News Items Archive - Almac

Almac Diagnostic Services Awarded Olink™ Certified Service Provider Status, Expanding Proteomics Capabilities for Biopharma Clients

chloefinch — Thu, 02 Jul 2026 08:52:09 +0000

Almac Diagnostic Services, a global leader in precision medicine and biomarker-driven clinical trial solutions, today announces that it has been awarded Certified Service Provider (CSP) status by Olink^TM, part of Thermo Fisher Scientific). This certification enables Almac Diagnostic Services to offer multiple Olink proteomics solutions to biopharmaceutical partners, further strengthening its multi‑omic capabilities across biomarker discovery, translational research and clinical development.

As an Olink Certified Service Provider, Almac Diagnostic Services delivers gold‑standard, high‑sensitivity proteomics services using Olink’s industry‑leading Proximity Extension Assay^TM (PEA) technology. The Almac service offering includes Olink^TM Target 48, Olink^TM Target 96, and Olink^TM Reveal panels, supporting studies ranging from focused pathway analysis to high‑throughput, large‑scale protein profiling.

The service is delivered through Almac’s CLIA‑certified and CAP‑accredited global laboratories, supported by ISO‑aligned quality systems, ensuring robust, reproducible data generation suitable for biopharma research and regulated clinical programmes.

Almac provides end‑to‑end proteomics support, including study design, sample preparation, library preparation, qPCR and NGS sequencing, data QC and advanced bioinformatics analysis. Secure sample storage and future re‑analysis options are also available, enabling long‑term value from precious clinical samples.

“Almac Diagnostic Services is dedicated to expanding our Multi-Omic Services portfolio, in response to client needs. Incorporating innovative technologies like Olink Proteomic panels helps to expand our offering for biopharma clients to include both molecular and proteomic solutions that are required for complex biomarker drug development programmes. We are also able to offer IHC, single cell and spatial transcriptomics as part of Almac’s overall offering.” said Laura Knight, VP of Genomic Services, Almac Diagnostic Services.

For more information about Almac Diagnostic Services’ proteomics offerings, visit:
www.almacgroup.com/diagnostics/proteomics-service

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Almac Diagnostic Services Expand NGS Capabilities for Clinical Trial Research

chloefinch — Tue, 02 Jun 2026 07:46:47 +0000

Almac adds Thermo Fisher Ion Torrent Genexus™ system to lab portfolio

Almac Diagnostic Services, part of the Almac Group, today announces further investment in its global Next Generation Sequencing (NGS) infrastructure to support biomarker driven clinical research.

This infrastructure expansion includes the addition of Thermo Fisher Scientific’s Ion Torrent Genexus™ System, which supports the delivery of high‑quality genomic data for biomarker discovery and patient stratification in both early- and late-phase clinical trials. It also strengthens Almac’s targeted DNA and RNA sequencing offerings, reinforcing its position as a trusted partner for precision medicine.

Sponsors will now benefit from an integrated, end‑to‑end NGS workflow made possible by the Ion Torrent Genexus™ System, which combines library preparation, sequencing, data analysis and reporting within a single platform. Automation of key steps reduces manual handling and variability, helping to deliver consistent, high‑quality genomic data with faster turnaround times.

By expanding NGS capabilities within its laboratory, Almac Diagnostic Services further strengthens its ability to support global clinical trials from its existing multi-omic laboratories in UK / Europe and the United States. This latest investment reflects its ongoing commitment to expand its clinical trial solutions, supporting biopharmaceutical partners evolving needs for global technologies that enable biomarker‑driven, drug development programmes.

Michael Sloan, Global Vice President of Commercial Operations, Almac Diagnostic Services, commented:

“This investment further enhances our NGS capabilities for biopharma partners. The platform supports faster, more streamlined genomic testing while maintaining the quality, consistency and regulatory rigour required for clinical trial applications.

It forms part of our ongoing strategy to invest in technologies that help customers accelerate development and bring targeted therapies to patients sooner.”

For more information on Almac Diagnostic Services range of services visit: www.almacgroup.com/diagnostics

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Almac Group delivers record year of growth

brendanhagan — Tue, 19 May 2026 07:58:24 +0000

Revenue rises to £1.1 billion, profit increases by 16%, and global workforce grows to more than 7,900 as long-term investment continues to drive expansion.

Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced record financial results for the year ending 30 September 2025, with revenue, profit and employee numbers all reaching their highest levels to date.

Annual accounts released today show revenue increased to £1.1 billion, up £71.9 million (7%) on 2024. Pre-tax profit rose by 16% to £138.9 million, compared with £119.3 million in the previous year, while employee numbers have grown by 6% over the same period.

Almac reinvests all profits back into the company to support long-term growth. These latest results mark the fifth year of Almac Group’s £500 million+ global capital investment programme, first announced in November 2021. Since then, employee numbers have increased by more than 2,000, with over half of these new roles created in Northern Ireland.

The programme includes major investment across diagnostic and pharmaceutical development and manufacturing, clinical production and distribution, commercial manufacturing and packaging, global cold-chain infrastructure, and analytical services. It also supports significant campus improvements designed to enhance the working environment for employees.

Almac now employs more than 7,900 people worldwide and plays a vital role in helping develop, manufacture, test and distribute essential medicines for patients around the globe. During the financial year, the Group supported the development and ongoing commercial supply of hundreds of life-saving drugs across more than 20 therapeutic areas, including oncology, cardiology, immunology, gene therapy and neurology.

Alan Armstrong, Almac Group Chairman and CEO, said:

“These results reflect another successful year for Almac and demonstrate the resilience of our long-term growth strategy in a changing global environment.”

As a privately owned company, we are proud to reinvest our profits to support our global clients, drive innovation and expand our capabilities. None of this would be possible without the exceptional commitment of our people across the globe.”

*The employee percentage number rise in the financial accounts relates to the average employment figure for FY 2024/2025 vs 2023/2024. Employee numbers currently exceed 7,900 as of May 2026.

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Almac Clinical Technologies Named “Best Clinical Trial Technology Solution Provider” in 2026 MedTech Breakthrough Awards Programme

thomasdrake — Thu, 07 May 2026 15:25:12 +0000

10th Annual Awards Programme Recognises the Most Innovative Digital Health and Medical Technology Solutions Worldwide

Almac Clinical Technologies today announced that it has been selected as winner of the “Best Clinical Trial Technology Solution Provider” award in the 10^th annual MedTech Breakthrough Awards programme conducted by MedTech Breakthrough, an independent market intelligence organisation that recognises the most innovative companies, technologies and products in the global digital health and medical technology market.

Almac earned the recognition for not only its broad commitment to advancing clinical trial execution through integrated technology, operational expertise and global support capabilities, but also for the impact of the company’s breakthrough new platform, Almac Trial Coordinator™.

Almac Trial Coordinator™ was introduced in 2025, delivering a next-generation orchestration solution that unifies the operational journey of a clinical trial, bringing together tasks, data, systems, and people into a single, intuitive experience. It features a role-based, multi-modal interface that presents accurate information to the correct user at the right moment.

Sites have the ability to consolidate visit windows, patient status, eCOA compliance, drug accountability, and study tasks, while sponsors and CROs gain oversight through intelligent dashboards, alerts, and predictors, enabling proactive decision-making.

In line with Almac’s integrated approach to trial technology, Almac Trial Coordinator™ offers seamless interoperability with Almac’s global IRT platform and with third-party systems, ensuring real-time data synchronisation and equipping teams with up-to-date operational information wherever needed. Early deployments have shown reduced site burden, fewer protocol deviations, more consistent data collection, and enhanced oversight.

“Our years of Clinical Trial Technology delivery and support experience have informed every component of the platform – from user experience to compliance safeguards. Almac Trial Coordinator™ is reliable in environments where precision, auditability, and regulatory alignment matter most. We are delighted to be recognised by MedTech Breakthrough for the impact Almac Trial Coordinator will continue to have on crucial studies and the patients that rely on them,” said Valarie Higgins, President and Managing Director of Almac Clinical Technologies.

Now celebrating its 10th anniversary, the MedTech Breakthrough Awards programme has spent a decade recognising the companies driving meaningful progress and improving patient care across the global health and medical technology industry. The programme spans a wide range of categories – including Telehealth, Clinical Administration, Patient Engagement, Electronic Health Records (EHR), Virtual Care, Medical Devices and beyond – honouring the innovations reshaping how care is delivered worldwide.

This year’s programme drew a record-breaking number of nominations from leading companies and startups across more than 20 countries, reflecting the growing global impact and momentum of the digital healthcare industry.

“Combining interoperability, automation, and user-centred design, Almac Trial Coordinator sets a new benchmark for how modern trials should be managed. The disconnect across individual technologies like eCOA, IRT, and more forces sites and study teams to rely on manual workarounds, duplicated data entry, and error-prone processes, slowing down studies, burdening sites, and complicating operational oversight,” said Steve Johansson, managing director, MedTech Breakthrough. “Almac Clinical Technologies delivers something genuinely transformative: a unified operational command centre designed to simplify, streamline, and elevate the clinical trial experience for all stakeholders. We’re pleased to award Almac Group with ‘Best Clinical Trial Technology Solution Provider!’”

Explore how Almac Clinical Technologies is transforming trial execution with integrated solutions and expert support – learn more on our dedicated resources page.

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Almac Sciences Launches New cGMP Flow Hydrogenation Capability

chloefinch — Fri, 13 Mar 2026 10:09:16 +0000

The company’s latest flow chemistry investment strengthens continuous processing offering for clinical and commercial manufacturing programs

Almac Sciences, a member of the Almac Group, is pleased to announce a significant expansion of its API and flow chemistry services with the launch of cGMP compliant flow high pressure hydrogenation. This new capability brings enhanced precision, safety, and scalability to one of the most critical transformations in modern synthetic chemistry and is now available for both clinical and commercial manufacturing programs.

Hydrogenation is an essential step across many synthetic routes and performing it under continuous flow conditions offers transformative benefits. Flow operation provides superior control over temperature, pressure, and mixing, enabling improved reaction performance, reduced impurity formation, and reliable reproducibility at scale. By integrating this technology under cGMP conditions, Almac Sciences now gives clients access to faster, safer, and more efficient hydrogenation up to 100 Bar pressure and 300 deg C with the confidence of full regulatory compliance and rigorous analytical oversight.

This advancement builds on over eight years of substantial investment in flow chemistry, during which Almac Sciences has developed deep expertise in packed-bed hydrogenation and demonstrated robust performance at scales exceeding 100 kg. The addition of cGMP capability further strengthens Almac’s position as a leading provider of manufacturing solutions.

“This investment marks a significant milestone for our team and our clients,” said Dr. Scott Wharry, Associate Director of Custom and Flow Chemistry at Almac Sciences. “By combining cGMP flow hydrogenation with our established expertise in cryogenic organometallic chemistry and large scale packed-bed hydrogenation, we are offering continuous processing capability today. These technologies not only improve safety and efficiency but also align with the industry’s drive toward sustainability and innovation.”

With this latest investment, Almac Sciences continues to expand its comprehensive continuous flow offering, providing global partners with cutting-edge technologies backed by the company’s multidisciplinary team of chemists, engineers, analysts, automation specialists, and project managers. This integrated expertise ensures clients receive not only technical excellence but also strategic guidance and support at every stage of their molecule’s journey.

Prof. Tom Moody, VP API Development and Commercialisation, added: “Flow hydrogenation under cGMP is a major step forward for our customers. It delivers enhanced process confidence, consistent high quality output, and exceptional scalability, all while reducing environmental impact and operational risk. As the industry increasingly prioritises safer, greener, and more flexible manufacturing solutions, this capability reinforces our commitment to supporting clients from early development right through to commercialisation.”

Find out more about our Flow Chemistry Capabilities

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Winter Storm impacting North America: Almac Group Update

evewallace — Mon, 26 Jan 2026 10:24:04 +0000

Due to the impact of Winter Storm Fern, and in the interests of employee safety, Almac Group has closed its North Carolina operations on 26th January. It is planned that business will resume as normal on Tuesday 27th January. Due to the adverse weather, Almac has also closed its Distribution & Production Operations in Audubon and Souderton, Pennsylvania until 3pm EST on Monday.

Almac is committed to continuity of supply for our clients, their patients and to excellence in our customer service. We will endeavor to mitigate any significant impact due to this short closure.

Impact on clinical shipments – North Carolina

There has been significant disruption to distribution routes in North Carolina and to our North Carolina facility. As a result, Almac has suspended all shipments on Monday 26th January.

We are working closely with our courier partners to limit any delays. Shipments originally planned for Monday will be collected and dispatched throughout Tuesday, 27 January. Please note that shipments scheduled for dispatch on Tuesday may experience delays of up to 24 hours.

If you have urgent concerns or critical shipments requiring prioritization, please contact our monitored helpdesk at logisticsservices@almacgroup.com.

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Almac Group releases 2025 Sustainability Report

evewallace — Thu, 18 Dec 2025 16:26:38 +0000

Almac Group today releases our 2025 Sustainability Report, which outlines the progress on our ongoing global commitments in the key areas of people, planet and the communities where we operate.

This year we made substantial progress on our environmental based goals. We received validation from the Science Based Targets initiative (SBTi) in June of this year for both our near and long-term emissions reduction targets— a recognition of our commitment to climate action in alignment with the latest climate science. We also report notable progress in the transition to renewable energy, with 54% of global operations now powered by renewable sources.

Reflecting our commitment to programmes that foster inclusive, healthy workplaces for our people, we were delighted to be a recipient of a ‘best practice’ commendation this year for employee health and wellbeing during ISO 45001 (health and safety) and ISO 14001 (environmental management) surveillance audits.

In the communities where we operate, we are proud that we supported 74 different charities through global philanthropy and reached more than 20,000 post-primary pupils through in-person and virtual outreach programmes.

Alan Armstrong, Chairman and CEO, Almac Group said: “Almac’s mission to advance human health continues to guide every aspect of our work and extends beyond the work we do for our customers to ensure a healthy and more sustainable future for the world around us.”

“The achievements outlined in this report reflect the passion and perseverance of our people – individuals I am honoured to work alongside. By living out our mission each day, they are collectively impacting human health across the globe”

Read the full report here

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Almac announces multi-million-pound investment in Singapore

brendanhagan — Mon, 17 Nov 2025 17:07:13 +0000

Almac Group has announced a multi-million-pound investment to expand its facility in Singapore, as the company marks ten years of operations in the country.

The investment by Almac Clinical Services is part of a long-term commitment to expand warehouse capacity in Singapore and increase regional clinical supply management expertise to address client demand.

This initiative supports our five-year growth strategy, which has included the quadrupling of dedicated -20°C capacity, expansion of secondary cold chain packaging capabilities and enhanced temperature-controlled clinical supply services. These investments address client expectations and market demand to support clinical trials from Singapore and to provide advanced cold chain solutions.

APAC continues to be one of the fastest growing markets for clinical trials, and Almac has seen unprecedented growth over the last ten years in line with this. Singapore offers clear benefits as a strategic centre for clinical packaging, along with both regional and global logistics.

Dr Robert Dunlop, President and Managing Director of Almac Clinical Services said: “We are proud to celebrate a decade of operations in Singapore. This investment reflects our unwavering commitment to advancing human health, not only in Asia-Pacific but globally.

“For over a decade our facilities in Japan and Singapore have played a pivotal role in enabling Almac to efficiently manage the APAC clinical supply chain, delivering significant value to our clients.

“It fuels our continuous improvement across services and infrastructure to support clients with securing the best possible outcome for patients worldwide. As we look ahead, we are committed to deepening our partnerships with existing and new clients, and we remain dedicated to our promise to Supply with Care.”

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Almac Group Launches “Farm to Fork Project” in Souderton Area Schools

chloefinch — Tue, 21 Oct 2025 13:05:10 +0000

Almac Group is proud to announce that the company has launched the “Farm to Fork Project,” a multi-phase experiential education and community building initiative to benefit the Souderton Area School District (SASD).

“Farm to Fork” is designed to demonstrate community health and stewardship through hands-on, agricultural and science-based classroom learning that centres on how local food is grown. Adoption into SASD curriculum was initiated by Almac Group and championed in collaboration with the Indian Valley Education Foundation (IVEF) and Garden of Health Food Bank, who will serve as advisors to the programme.

The programme launches this year at all six district elementary schools and will eventually unfold in three yearlong stages — Discover, Learn, and Thrive. During this three-year period, $30,000 in programme-enabling extracurriculars will be financially supported by Almac Group.

This inaugural year, “Discover,” just commenced with an immersive education session at Garden of Health’s Hatfield Farm for all fifth graders, including experiences ranging from harvesting, drying and identifying herbs, transplanting seedlings, and beekeeping.

In the future, Almac’s support will expand to in-classroom and outdoor classroom-based growing needs, including “ready to grow kits” for each participating classroom to facilitate and complement the formal curriculum roll out in Fall 2026.

“Farm to Fork was born from our vision to create a meaningful, place-based learning experience here in Souderton that tangibly shows students how food, agricultural science, health and community are interconnected,” said Mark Rohlfing, Vice President of Operations, Almac Group.

The programme is the latest addition to Almac’s long repertoire of pioneering educational, STEM-based enrichment experiences for students in the communities where they operate. In the past three years, the company has reached over 5,000 students through sponsored enrichment experiences in Northern Ireland, the home of the company’s Global Headquarters.

“We’re proud to build on our global commitment to STEM education through Farm to Fork and look forward to its positive impact over the next three years,” Mark Rohlfing continued.

“Farm to Fork strengthens our science curriculum by connecting hands-on learning to real-world purpose,” said Katie Kennedy-Reilly, Director of Curriculum, Instruction, Assessment, and Technology K-12. “Through this programme, students explore the relationship between food, health, and community in ways that nurture curiosity, compassion, and a sense of belonging. It reflects our commitment to whole-child learning and to helping students see themselves as innovators and stewards of the future.”

“By planting the seeds of curiosity early, we are nurturing the next generation of community leaders,” said RuthE Potter, Executive Director of the Indian Valley Education Foundation. “This programme is a shining example of what’s possible for our children when industry, nonprofits, and schools work together.”

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Almac Trial Coordinator Launched in $48 Million Investment to Advance Integrated eClinical Technologies

thomasdrake — Tue, 14 Oct 2025 13:30:04 +0000

Innovative technology platform reshapes how sponsors, CRO, and clinical sites manage complex clinical trials at scale

Almac Group has today announced a $48 million investment in eClinical technologies that includes the launch of Almac Trial Coordinator™ – a first-in-class interoperable clinical trial technology platform, enhancements to its eClinical ecosystem capabilities, and creation of over 100 advanced technology roles globally. This investment addresses the top technology challenges facing sponsors, CROs, and clinical sites through the solution’s market-disrupting and interoperable approach to integration, enabling high-quality, efficient trials with full visibility, reduced risk, and enhanced patient engagement.

Almac Trial Coordinator™ is purpose-built to unify operational processes, clinical data, and systems into one unified protocol. The platform is novel due to its unique ability to meet the industry’s pressing and unmet system fragmentation challenge, offering both standardisation and flexibility where trials and data providers differ. This supports sponsors in futureproofing their technology strategy, eliminates vendor lock-in, and greatly expands the number of sites capable of meeting the demands of modern clinical trials.

The platform features open APIs and standards-based exports to fit modern tech stacks to ensure interoperability for its users- offering full visibility across connected solutions and supporting fast, low-disruption protocol amendments through controlled workflows. Key usability features include intuitive, role-specific interfaces, two-tap onboarding, 24/7 multilingual support, and built-in localisation and validation. These leading features are all underpinned by strong data provenance and reusable libraries of standardised study templates to accelerate study build and ensure quality.

“This investment underscores our commitment to delivering flexible, scalable solutions that empower sponsors and sites to run complex trials with confidence and efficiency,” said Valarie Higgins, President & Managing Director at Almac Clinical Technologies. “Almac Trial Coordinator™ is a transformative solution with a unique focus on streamlining the site’s ability to navigate today’s eClinical ecosystem with confidence and ease – addressing a critical industry need that does not get enough attention.”

Kees van Ooik, Vice President of eClinical Solutions, added: “Our vision is to simplify complexity and deliver measurable value through an integrated eClinical ecosystem. This investment enables us to enhance interoperability, improve user experience, and meet the evolving needs of global clinical trials.”

Learn more Book a demo

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Almac Group launches collaboration with Young Enterprise

brendanhagan — Tue, 30 Sep 2025 08:00:00 +0000

Alan Armstrong, CEO Almac Group said: “At Almac, we’re committed to investing in the next generation of talent who may one day contribute to our mission to advance human health. Over the last year alone we have reached over 17,000 students through our various programmes including direct engagement with schools, colleges and strategic partnerships.

Almac Group has today announced its collaboration with Young Enterprise NI as an ESG Business Backer, as part of the Group’s talent outreach programme.

As one of Northern Ireland’s largest indigenous companies, Almac currently employs over 7,700 people globally, over 4,000 of whom are based in Northern Ireland.

Almac has developed a team of 11 mentors spanning a range of disciplines including finance, legal, IT, HR, engineering and marketing, who will work with students from three schools throughout the course of the academic year.

“We are looking forward to this new collaboration with Young Enterprise which gives us another opportunity to inspire young people and have a positive impact on the communities where we operate.”

Carol Fitzsimons MBE, CEO of Young Enterprise Northern Ireland, welcomed Almac Group’s support: “We are delighted that Almac has joined us as an ESG Business Backer. Almac represents the best of entrepreneurial culture and skills in Northern Ireland, and local students will benefit from learning from their global expertise.”

This partnership marks another milestone in Young Enterprise’s growing network of business backers who are committed to fostering an entrepreneurial culture and supporting the development of future talent in Northern Ireland.

Almac’s ongoing outreach programme includes direct engagement with schools, strategic partners including the Almac MED-LAB at W5, scholarship programmes and work experience opportunities.

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Almac Group Expands Bioavailability Enhancement Capabilities – Addressing a critical need in drug development

chloefinch — Tue, 09 Sep 2025 14:45:00 +0000

Almac Group has completed a multi-million-pound expansion of its bioavailability enhancement capabilities at its facility in Charnwood, UK.

The significant investment by Almac Pharma Services, will address ongoing industry challenges around solubility and growing global demand for advanced formulation solutions. The investment includes the installation of Buchi S300 and GEA PSD1 closed-loop spray drying technology and extensive expansion of the facility’s analytical laboratories.

This new technology, coupled with existing liquid capsule filling and non-sterile oral liquid formulation solutions at the facility, widens Almac’s bioavailability enhancement capability. The new technologies’ containment capabilities also complement existing potent-handling capabilities at the site.

This latest clinical investment expands on Almac’s long-standing pre-clinical expertise in bioavailability and amorphous solid dispersion development using a range of technologies including spray drying and melt extrusion. Almac also offers advanced particle engineering technologies and supporting analytical capabilities.

This expansion of market-leading technologies and expertise across Almac’s scientific teams now bridges the gap between pre-clinical and clinical drug development and gives clients even greater access to a range of advanced formulation approaches. This results in delivering a faster route to market for our clients, improved therapeutic performance and ultimately better patient outcomes.

James Hurst, VP Operations and Charnwood Site Head, Almac Pharma Services said: “This investment is a direct response to the growing demand for sophisticated formulation solutions. Spray drying is a cornerstone technology for enabling next-generation therapeutics, and our expanded capabilities ensure we remain at the forefront of pharmaceutical innovation. Our clients trust us to deliver precision, speed, and scientific excellence – this investment reflects our ongoing commitment to supporting clients with advanced technologies and expertise that drive success.”

This latest announcement builds upon the Group’s £11m investment in global analytical capabilities and comes just months after Almac Pharma Services officially opened its 100,000 square foot commercial manufacturing facility at its global headquarters in Craigavon, Northern Ireland. The £65 million facility further strengthens Almac’s end-to-end service offering, reinforcing the company’s ongoing commitment to expanding capacity, advancing technological innovation, and supporting clients worldwide with industry-leading pharmaceutical development and manufacturing solutions.

Find out more about our Bioavailability Enhancement Capabilities

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Almac Group Expands US Analytical Capacity with New Stability Chambers in Souderton, PA

brendanhagan — Fri, 01 Aug 2025 09:00:00 +0000

Almac Group has announced the official opening of new GMP-qualified analytical stability chambers and office space at its US Headquarter campus in Souderton, Pennsylvania. This $2 million investment builds on the multi-million-dollar expansion of global analytical services and reinforces Almac’s commitment to meeting growing client demand.

The new facility includes 1,600 ft² of dedicated stability chamber space and an additional 1,600 ft² of modern office accommodation / laboratory space. The chambers are fully GMP-qualified and equipped with alarmed and redundant systems and utilities, supporting all standard ICH and custom stability conditions including: -20°C, 5°C, 25°C/60%RH, 30°C/65%RH, 30°C/75%RH, and 40°C/75%RH.

This expansion significantly increases Almac’s capacity and capability to support clients’ global stability programmes and enhances operational flexibility across its US and European sites. As the business continues to grow, headcount at the Souderton site is expected to increase to support the expanded service offering.

Dr Stephen Barr, Managing Director & President, Almac Sciences said: “Client demand for stability services is growing, and this investment is a direct response to that need.

“By expanding our footprint in Souderton, we are future proofing our operations and ensuring that we can continue to deliver the high-quality, compliant services our clients expect.”

“This new space is a testament to our commitment to continuous improvement and innovation,” added Joseph Forth, Director of Analytical Operations, Almac Sciences, Souderton. “Our expert analytical teams bring a wealth of experience, skill, and knowledge to every project, and this investment ensures we are well-positioned to support our clients’ evolving needs.”

This latest development complements Almac’s strong track record in delivering expert analytical services globally. With over 700 highly skilled analysts operating across five GMP-approved sites in the UK, Ireland, and the US, Almac offers a comprehensive suite of analytical testing services from early development through to commercial release.

For more information, visit www.almacgroup.com.

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Almac Group North Carolina – 25th Anniversary Celebrations

brendanhagan — Tue, 29 Jul 2025 15:14:36 +0000

Almac Group in Durham, North Carolina is celebrating its 25^th anniversary!

Almac first established a presence in the US in 1996 with the opening of its clinical trial operations in Audubon, Pennsylvania.

In 2000, Almac acquired the Duke Clinical Research Institute Pharmacy (DCRIP), which established our presence in North Carolina. Over the last 25 years the site has grown from 30 employees to more than 450 employees and is home to Almac Clinical Services, Almac Diagnostic Services, Almac Clinical Technologies and Almac Group support. The campus has also expanded from 1 facility to 4, housing offices, warehousing, production and drug returns.

Expanding into North Carolina significantly advanced the development of Clinical Services’ Supply Chain Management services across all global locations.

WebEZ was created and launched from North Carolina in 2006. WebEZ, the world’s first configurable randomisation system, has enabled hundreds of clinical trials to transition from manual methods to robust automated solutions for randomisation and drug ordering.

Our Durham facility continues to lead in innovation, most recently with the introduction of cutting-edge UltraLow and Cryogenic solutions designed to meet the needs of the expanding Biotech sector. The site recently implemented a –70C purpose built large-scale storage unit for critical medicines and temperature-sensitive product. This is one of the first units of its kind in the US.

In 2015 Almac Diagnostic Services established a US laboratory at the Almac Durham site to provide biomarker testing solutions for global clinical trials. Now CAP, ISO15189 and ISO13485 certified, the facility has delivered testing using Almac-developed novel biomarker assays across a range of technologies for both US based and global clinical trials, directly impacting treatment for thousands of patients to date.

Almac Clinical Technologies has focused on the design, project management and oversight of IRT systems for pharmaceutical and CRO clients.

Donna Christopher, Global VP Operations, Almac Clinical Services said: “We are proud to mark our 25^th year in North Carolina and to celebrate the impact that our facility has on Almac’s global success in supporting our clients and contributing to the advancement of human health. As well as our contribution to the local community as a premier employer in Durham.”

For more information, visit www.almacgroup.com.

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Almac completes a multi-million-pound Investment Enhancing Cold Chain Capabilities in Craigavon

brendanhagan — Mon, 07 Jul 2025 10:58:47 +0000

Almac Clinical Services, part of the Almac Group, has completed a multi-million-pound investment to enhance cold chain capabilities at its global headquarters in Craigavon, Northern Ireland.

This strategic investment includes the completion of a purpose-built Ultra-Low Temperature facility which has tripled Almac Clinical Services’ -15°C to -25°C secondary packaging capabilities and doubled ultra-low temperature storage capacity (-60°C to -80°C) in Craigavon.

This investment is part of Almac’s global ongoing programme to expand Ultra-Low capabilities, including North Carolina and Singapore facilities which have already been completed.

Almac has also expanded its cold chain packaging capabilities and increased capacity by more than 60% in the Craigavon facility. The recent developments include an upgraded cold chain management centre with additional 2°C to 8°C secondary production rooms; new label printing and checking suites and new packaging design facilities.

This investment significantly expands the company’s global clinical supply to support biopharmaceutical products and will meet growing demand for Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies, which require ultra-precise cold chain logistics to maintain product viability and compliance.

Dr Robert Dunlop, President and Managing Director of Almac Clinical Services said: “Almac is committed to supporting trial sponsors around the world to champion innovation and advance human health.

As the number of biological products in clinical development continues to grow, it is important that Almac can offer both the capability and capacity that clients will require in the future. The expansion of our existing Cold Chain management centre in Craigavon offers a prime solution to many of the manufacturing and supply chain challenges that impact the success of clinical trials.

“Combined, we’re proud to provide strict GMP environments, robust cold chain logistics and quality control through our state-of-the-art, ultra-low, temperature-controlled storage and production capability. This enables sponsors to deliver compliant and cost-effective packaging and labelling of biological IMPs and keep patient supply at the heart of our operations.

“These investments are a testament to our strategic vision to stay ahead of industry needs. By expanding our infrastructure and capabilities, we are ensuring that Almac remains a trusted partner in the evolving landscape of clinical trials.”

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Almac Group announces validated near and long-term science-based emissions reduction targets with the Science Based Targets initiative (SBTi)

thomasdrake — Mon, 02 Jun 2025 13:00:00 +0000

The Almac Group has received validation from the Science Based Targets initiative (SBTi) for its emissions reduction targets. This milestone is another recognition of Almac’s commitment to sustainability and climate action in alignment with the latest climate science.

As part of its long-standing dedication to environmental stewardship, Almac has set robust targets aimed at reducing greenhouse gas emissions across its operations. These targets, now validated by the SBTi, are designed to support the global effort to limit temperature rises to 1.5°C above pre-industrial levels.

Key targets include the following:

Almac Group Limited commits to reach net zero greenhouse gas emissions across the value chain by FY2045
Near-term targets: Almac Group Limited commits to reduce absolute scope 1 and 2 GHG emissions 50% by FY2030 from a FY2019 base year. Almac Group Limited also commits to reduce absolute scope 3 GHG emissions 27.5% within the same timeframe
Long-term targets: Almac Group Limited commits to reduce absolute scope 1 and 2 GHG emissions 95% by FY2045 from a FY2019 base year. Almac Group Limited also commits to reduce absolute scope 3 GHG emissions 90% within the same timeframe

Emissions reductions will be achieved through a comprehensive net zero strategy which includes a transition to renewable energy via a virtual Power Purchase Agreement (vPPA) with a local wind farm provider providing power for our Craigavon headquarters, energy efficiency programmes under ISO50001(a key standard in energy management and conservation) and sustainable procurement practices. Almac is also committed to transparent reporting via sustainability organisations and platforms. The validation of our reduction targets by the SBTi represents a key milestone in Almac’s net zero journey.

Niall Harkin, Executive Director, Almac Group said: “We are immensely proud to have our targets validated by SBTi. This validation reflects our rigorous approach to climate action and reinforces our commitment to making a measurable and positive impact on our planet. We are dedicated to driving sustainability throughout our operations and across the pharmaceutical and biotech sectors.“

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Almac Group surpasses £1 billion revenue with latest Annual Accounts reporting record revenues, profit and employee numbers

chloefinch — Wed, 28 May 2025 13:30:00 +0000

Almac Group, the global contract pharmaceutical development and manufacturing organisation, has today announced its highest ever revenue, profit and employee numbers.

Figures released for Almac’s financial year ending 30 September 2024 reported £1.027 billion of revenues, a £69.5 million (7%) increase from 2023. Pre-tax profits rose by 27% to £119 million, up from £93.8 million in the previous year, and average employee numbers grew by 3% over the same period.

Almac reinvests all profit back into the business and these financial results mark the fourth year of Almac Group’s £400 million+ global capital investment programme, announced in November 2021. This programme has included the development of a Centre of Excellence for Diagnostic development and commercial manufacturing, a state of the art 100,000 sq ft pharmaceutical manufacturing facility, and an expansion of cryogenic and ultra-low temperature service capabilities for clinical supply across Durham, North Carolina and Singapore. A major expansion continues to clinical production and distribution capabilities in Souderton, Pennsylvania.

Almac, which currently employs more than 7,700 people worldwide, is at the forefront of developing, manufacturing, testing and distributing essential medicines to patients around the world. During this financial year the group was involved in the development of hundreds of life-saving drugs spanning more than 20 therapeutic areas including oncology, cardiology, immunology, gene therapy and neurology.

Alan Armstrong, Almac Group Chairman and CEO said: “Today’s results mark another successful year of growth for Almac. As a privately-owned and independent company, we re-invest all our profits back into the business, enabling us to innovate and expand to meet the growing needs of our global clients, working in partnership to advance human health.

“I am proud of the continued progress we are making, which is thanks to the dedication of our valued global workforce.”

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Almac Clinical Services wins ‘Innovation in Distribution’ award at the Making Pharmaceuticals Awards

chloefinch — Thu, 08 May 2025 15:17:59 +0000

Almac Clinical Services has won the ‘Innovation in Distribution’ award for the Almac Pod™ at the 2025 Making Pharmaceuticals Awards.

Sharon Courtney, Lead Innovator for Almac Pod™ said: “The Almac Pod™ is a tangible embodiment of our mission to supply with care. We are proud to have received this award, which recognises our unwavering dedication to pioneering safer, smarter, and more sustainable pharmaceutical logistics for the patients who rely on us most.

“By integrating advanced temperature control, GPS-enabled tracking, and a circular return-and-reuse model, we have reshaped industry standards in sustainability, compliance, and patient care.”

Almac Clinical Services was also shortlisted for the ‘Sustainability in Distribution’ award, highlighting our commitment to environmental responsibility in pharma logistics.

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Almac Discovery and Formosa Pharmaceuticals announce global licensing agreement for development and commercialisation of ALM-401, a first-in-class EGFRxROR1 Bispecific Antibody-Drug Conjugate

evewallace — Tue, 06 May 2025 13:06:43 +0000

TAIPEI, Taiwan and BELFAST, Northern Ireland – 6 May 2025 – Formosa Pharmaceuticals, Inc. (“Formosa”; 6838.TW ticker-symbol on the Taiwan Stock Exchange) and Almac Discovery announce a global licensing agreement for development and commercialisation of ALM-401, a first-in-class engineered bispecific Antibody-Drug Conjugate (ADC), addressing the high unmet needs of cancer patients worldwide suffering with intractable and aggressive solid tumours.

The agreement facilitates the next phases of CMC and drug development by Formosa, including IND submission and early clinical proof-of-concept in international clinical trials.

ALM-401 has been the culmination of a multi-year R&D programme at Almac Discovery deploying their proprietary OmniaScape™ informatics platform, protein engineering and medicinal chemistry capabilities.

The design of ALM-401 has built upon the recent clinical successes within the ADC field, including selection of a linker-payload matched to potential clinical cancer indications, and the molecule also benefits from being approximately half the size of conventional ADCs, thereby facilitating enhanced solid tumour penetration. The main features of ALM-401 include:

Innovative bi-specific target-pairing based on co-expression and functional analysis of specific, aggressive solid tumours
Sustained high-efficacy in vivo in PDX models; as presented at the 2025 American Association for Cancer Research (AACR; Chicago) annual meeting
Half-the-size of conventional ADCs for enhanced solid tumour penetration and optimised manufacturing.

Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology, with particular CMC and manufacturing expertise for specialist ADC therapeutics. “Formosa Pharma is pleased to have this opportunity to bring ALM-401 into our development pipeline. This novel, next-generation ADC complements our corporate strategy and resources and promises to deliver a differentiated therapy to cancer patients worldwide. We look forward to collaborating closely with Almac Discovery in advancing this exciting program through clinical trials, commercialization, and beyond.” said Dr. Erick Co, President and CEO of Formosa Pharmaceuticals.

“We are pleased to have met Formosa’s exacting selection requirements for Next Generation ADC candidates,” said Dr Stephen Barr, President and Managing Director of Almac Discovery. “This agreement allows the seamless progression of the molecule into clinical evaluation, driven by Formosa.”

“In addition to an excellent preclinical efficacy profile, high-quality, robust and scalable CMC and manufacturing is a key competitive advantage for ADCs in the fast-moving race for effective cancer therapeutics” commented Dr Graham Cotton, Vice-President of Protein Therapeutics, Almac Discovery.

ENDS

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company’s flagship program, APP13007, is a novel topical formulation of the potent corticosteroid, clobetasol propionate, and was approved by the US FDA in 2024 for the treatment of post-operative inflammation and pain following ocular surgery, with multiple regional licensing partners worldwide. The company’s proprietary nanoparticle formulation technology (APNT^®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. For more details please visit www.formosapharma.com

Contact:

Mr Wayne Wei, MPH, CLP, RAC

Chief Strategy & Business Officer

E: waynewei@formosapharma.com

About Almac Discovery Limited

Almac Discovery has drug discovery facilities in Belfast, Edinburgh and Manchester. It is led by an experienced team with a track record in delivering successful pre-clinical programmes. Internal capabilities include discovery biology and bioinformatics, protein engineering, medicinal chemistry and translational sciences. Almac Discovery utilises its unique blend of protein engineering and small molecule capabilities to create and develop First in Class and Best in Class NCEs through to the pre-clinical candidate/IND-ready stages, after which it seeks to collaborate with partners to accelerate their development.

The Discovery business benefits from collaboration and licensing partnerships with global R&D-focused biotech and pharmaceutical organisations.

Contact:

Dr Enda Gribbon

Business Development and Licensing

E: enda.gribbon@almacgroup.com

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Almac Diagnostic Services launches PNPLA3 Genotyping Kit for Liver Disease Research

chloefinch — Thu, 01 May 2025 15:17:34 +0000

~Almac kit will assist researchers with further insights into MASH / MASLD biology ~

Almac Diagnostic Services, a member of the Almac Group, has today announced the launch of a new PNPLA3 genotyping kit for liver disease research. This novel kit provides accurate genotyping of the PNPLA3 gene within a simple workflow, providing researchers with further biological insights into steatotic liver disease (including MASH and MASLD).

The Almac qPCR based kit delivers highly repeatable and reproducible results (≥99%) from blood or buccal swab specimens, with hands-on time of less than 30 minutes. It includes three genotyping assay controls to ensure confidence for researchers in allelic assay calls.

Metabolic dysfunction-associated steatotic liver disease (MASLD), is one of the most common forms of chronic liver disease, with an estimated prevalence of about 30% across many countries.¹The I148M genotype variant of the PNPLA3 gene is linked to liver disease severity and fibrosis progression even in the absence of classical metabolic dysfunction such as obesity.

By providing a reliable method to genotype the PNPLA3 gene, Almac is enabling researchers to identify genetic risk factors to understand the underlying genetic predisposition to MASLD better, to investigate how the I148M variant influences disease severity and fibrosis progression, and to develop future targeted therapies through better disease population understanding.

Michael Sloan, Global VP of Commercial Development, Almac Diagnostic Services said: “The launch of the Almac PNPLA3 Genotyping Kit represents our commitment to providing researchers with the tools they need to uncover useful biological information to further precision medicine in liver disease.”

Almac Diagnostic Services will be attending EASL 2025 in Amsterdam from 7-10 May to launch and promote the new kit. EASL is one of Europe’s largest liver disease conferences. Almac will be exhibiting at Booth #BS7 in Hall 12. See: https://www.almacgroup.com/events/easl-congress-2025/

To find out more about Almac’s PNPLA3 Genotyping Kit and to order go to: https://www.almacgroup.com/diagnostics/almac-pnpla3-genotyping-kit/

References:

¹ – The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review https://pubmed.ncbi.nlm.nih.gov/36626630/

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Almac Diagnostic Services adds single cell sequencing to its lab services to further enable biopharma clients research needs

chloefinch — Wed, 26 Mar 2025 09:00:00 +0000

Almac Diagnostic Services, a member of the Almac Group, has announced the launch of a new single cell RNA sequencing service. This addition will enhance its genomic services portfolio, providing biopharma clients access to the latest methods for biomarker research.

The Almac Single Cell Next Generation Sequencing (NGS) solution for biomarker discovery leverages the 10x Genomics Chromium X platform and chemistries to produce RNA-Seq data at the cellular level. This service is compatible with cell suspensions stored in Cryo-preservative or treated with Formaldehyde.

Almac’s Single Cell Sequencing service features a scalable bioinformatic pipeline powered by 10x Genomics’ Cell Ranger software, ensuring comprehensive quality control and precise single cell gene expression analysis. Clients can also opt for Almac’s custom bioinformatics solutions, which include cell type identification, differential expression analysis between cell types and pathway analysis.

Almac Diagnostic Services lab is the first commercial laboratory in Northern Ireland to achieve 10x Genomics Certified Service Provider (CSP) status. The certification was awarded in recognition of Almac’s expertise and data quality for single cell RNA-Seq projects. The CSP status ensures that clients benefit from best practice, are supported to overcome research challenges and can accelerate projects with confidence in the results.

Dr Laura Knight, Global VP of Genomic Services, Almac Diagnostic Services said: “By integrating Almac’s single cell workflows and bioinformatics options with 10x Genomics’ Chromium technology, we empower our clients with high quality single cell sequencing solutions to advance their translational medicine goals.

“Almac Diagnostic Services is dedicated to expanding our Genomic Services portfolio, in response to client needs, incorporating innovative technologies like single cell sequencing. We are also exploring spatial genomics solutions as part of our ongoing commitment to innovation.”

“At 10x Genomics, we deliver powerful, reliable tools that fuel scientific discoveries, and we’re thrilled that Almac Diagnostic Services is bringing our Chromium platform to its clients, expanding access to cutting-edge single cell technology for biopharmaceutical research,” said Everton Bačić-Robinson, Vice President, EMEA, 10x Genomics. “This collaboration will help accelerate scientific insights and advancements in biomarker research, and we’re excited to be part of that impact.”

To find out more about Almac single cell RNA Sequencing Solutions visit: https://www.almacgroup.com/diagnostics/rna-sequencing-solutions/

To find out more about 10x Genomics CSP providers visit: https://www.10xgenomics.com/service-providers

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Almac Pharma Services Opens Doors on £65m New Commercial Manufacturing Facility

thomasdrake — Tue, 11 Mar 2025 16:00:00 +0000

Almac Group has today announced the official opening of a new, state-of-the-art, £65m commercial manufacturing facility for Almac Pharma Services at its global headquarters in Craigavon, Northern Ireland.

The new 100,000sq ft facility enhances existing capabilities in commercial manufacture of oral dose treatments for a variety of therapeutic areas. The high-specification production suites, managed by Almac Pharma Services’ experienced scientific and operational teams, are fully equipped with the latest in pharmaceutical manufacturing technology and includes an extension to current production scales of potent and highly potent drug products.

Construction of the building was completed in late 2024 and following successful completion of validation activities, manufacture of GMP batches will commence next week (18th March) in the regulatory approved facility. This Centre of Excellence has been designed with flexibility and a wide range of uses in mind and includes opportunities for partner companies to install custom and / or dedicated technology tailored to their individual and emerging pipeline needs.

“We are thrilled to officially open our new commercial manufacturing facility at our global headquarters site,” said John McQuaid, President and Managing Director, Almac Pharma Services. “This investment underscores our commitment to supporting our clients’ growing needs with the highest level of service and expertise.

“The new facility not only expands our range of capabilities but also reinforces our position as an industry leader in pharmaceutical development and commercial manufacturing with an ability to tailor our services to suit individual products. It also demonstrates our commitment to working in true partnership with our clients as we support them in bringing important new therapies to the patients we serve.”

This £65 million investment by Almac Pharma Services in Craigavon marks a significant milestone in Almac Group’s ongoing global expansion programme. Almac Group initially committed to £250 million in capital investment and a growth of 1,800 new jobs across the Group globally in 2022. Since then, the Group has increased its projected investment figure to over £400 million.

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Almac Pharma Services expands with exciting career opportunities

thomasdrake — Wed, 26 Feb 2025 15:52:49 +0000

Almac Pharma Services is hosting an information day at the Seagoe Hotel, Portadown on Tuesday 1^st April from 12pm to 7pm.

Almac is actively recruiting for a range of roles based at the headquarters in Craigavon, which are available to suit people no matter what their qualifications or experience. All of the jobs offer a competitive salary and huge potential to progress in a rewarding and varied career.

There are opportunities available within manufacturing and packaging operations, including Grade II and III Senior Operators with various shift patterns including early/late rotating shift and permanent night shifts. Salaries range from £33,998 for a Grade II position (early/late rotating shift) up to £44,638 for a Grade III position (continental night shift).

The company is also hiring Graduate Production Technicians suitable for individuals with a third level education (e.g. HNC, HND (or higher) in a Life Science or Engineering subject), and no previous experience. This offers a clear career pathway where successful hires can expect to progress to a Production Technician within two to three years, dependent on performance.

There are numerous opportunities available for Production Technicians aimed at individuals with significant relevant experience working within the pharmaceutical industry or in an engineering environment.

Representatives from operations and engineering will provide company overviews with more information on the type of roles available, career pathways across the Almac Group and an insight into the company culture. HR representatives will also be present to provide advice on completing application forms and discuss the benefits that exist within Almac.

Tom Hegarty, Director, Operations – Manufacturing, Almac Pharma Services said: “We are excited to open our doors to passionate and talented individuals who are keen to make a difference in the pharmaceutical industry.

“Our open day is a fantastic opportunity to learn about the diverse and rewarding career paths at Almac Pharma Services. Join us to meet our dedicated team, explore our innovative roles, and discover how you can grow with us. We look forward to welcoming you and helping you take the next step in your career journey.”

To find out more about the roles or register for our recruitment event visit – https://www.almacgroup.com/careers/recruitment-open-day-craigavon/

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Almac invests £500,000 in state-of-the-art instrumentation within spectroscopy laboratories

brendanhagan — Fri, 17 Jan 2025 11:02:40 +0000

Almac Sciences, a member of the Almac Group, has invested £500,000 in state-of-the-art instrumentation within its spectroscopy laboratories at its global headquarters in Craigavon, Northern Ireland.

Almac is committed to providing the best analytical facilities for its customers and the recent purchase of the new Agilent 6545XT AdvanceBio Q-TOF Mass Spectrometer and a Malvern Panalytical Empyrean X-Ray Powder Diffractometer supports this goal.

This latest investment is additional to the company’s announcement in October 2024 of an £11million spend to expand Almac’s global analytical services capabilities, which includes the creation of 100 jobs.

The Craigavon laboratories house state-of-the-art Mass Spectrometers, X-Ray Powder Diffractometers as well as Nuclear Magnetic Resonance Spectrometers. These investments substantially increase the company’s capabilities in solving complex analytical challenges and provide additional security for urgent analyses, additional processing capabilities, and superior data integrity controls to ensure increasing regulatory compliance needs are met.

Within the dedicated facility, equipped with advanced LC-MS, GC-MS, ICP-MS, XRPD and NMR instrumentation, clients can benefit from a range of spectrometry services, including the quantitation of genotoxic impurities, trace elemental analysis, isotopic purity determinations, structure elucidation, analysis of peptides, proteins, glycoproteins and antibody products as well as polymorph screening, confirmation and quantitation of crystalline phases.

Dr John Malone, Associate Director of Spectroscopy, Almac Sciences said: “The continued investment and growth in our spectroscopy laboratories underlines Almac’s commitment to providing the best analytical facilities for its customers, and seamlessly meeting their needs.  We are delighted to offer our clients cutting-edge technology that supports their product safety imperative and accelerates the drug development cycle.”

Dr Darren Thomas, Vice President of Analytical Operations commented: “As we continue to enhance our analytical capabilities, our commitment to excellence remains unwavering. This substantial investment in cutting-edge technology emphasises our dedication to offering comprehensive analytical solutions to clients around the world.”

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Almac Acquires Your Research to expand eClinical solutions for participants, sites and sponsors

thomasdrake — Wed, 11 Dec 2024 08:00:00 +0000

Almac Clinical Technologies’ expands capabilities to accelerate clinical trials, by adding advanced solutions including electronic Clinical Outcome Assessments (eCOA), eConsent, Visit Management, and participant retention.

Almac Clinical Technologies, a member of the Almac Group, today (11 December) announced the acquisition of Your Research, an innovative Netherlands-based clinical trial software company.

Your Research software will become a key element of Almac Clinical Technologies and will enhance the experience for participants, sites, and sponsors alike. A phased rollout is planned to start mid-2025, with broader expansion anticipated later in the year.

As the clinical research landscape becomes increasingly complex, the need for efficient, high-quality, and participant-focused tools is greater than ever. Your Research’s advanced solutions and expertise in participant-centric technology complement Almac’s current offerings, enabling Almac to provide industry leading clinical trial technology, expertise, and seamless service at every stage along the participant’s journey.

These new solutions will provide a seamless clinical trial experience making it easier for sites and participants to engage with the study, and sponsors to gather and analyse data in real-time. The acquisition reflects Almac Clinical Technologies’ proactive approach in anticipating and solving key challenges faced in the clinical trial process.

Valarie Higgins, President and Managing Director of Almac Clinical Technologies, said: “Almac’s acquisition of Your Research signifies a bold step towards innovation in clinical trials. By prioritising a service-driven approach, Almac is not just enhancing our software offerings; we are transforming the clinical trial experience for participants, sites, and sponsors.”

Kees Van Ooik, Co-Founder of Your Research, added: “Almac’s dedication to service excellence and innovation aligns perfectly with Your Research’s data and participant management system. Paired alongside Almac’s industry leading IXRS®3 IRT solution, we will provide trial stakeholders with an unprecedented level of insight and automation, further increasing data quality and adherence while making it easier to navigate complex clinical trial processes and the current multitude of systems.”

Cheryl Kole, Vice President, Solution Strategy and Commercialisation said: “This acquisition is an exciting advancement for Almac! It enables us to deliver a wider array of services, further reinforcing our commitment to delivering trusted solutions and support for clinical trials.”

For more information: https://www.almacgroup.com/clinical-technologies/your-research

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Almac Group launches Climate Action initiative with local primary schools

brendanhagan — Tue, 10 Dec 2024 10:00:12 +0000

The Almac Group has launched a new sustainability initiative for Primary 6 and 7 children across Northern Ireland. The “Climate-Action-in-a-Box” programme is a five lesson, hands-on resource specifically designed to engage and educate children with a solution-based programme exploring climate change and action.

Almac is investing £30,000 in the programme and plans to reach 2,000 children across 40 primary schools over the next three years. This new initiative is part of Almac’s overall sustainability strategy – supporting the health of our planet, looking after their employees, and making a positive impact in the communities where they operate.

Niall Harkin, Executive Director for Almac Group said: “At Almac, we want to help children understand the science of climate change and the part they can play in contributing towards a greener future.

“We are delighted to launch this programme to deliver hands-on, creative lessons to local primary school children, and support teachers in encouraging positive climate action.”

St Francis’ Primary in Lurgan is one of six local primary schools who have received the programme resources as part of the initial roll out. World Around Us and Eco Coordinator Dwyer Coleman said: “This is an amazing opportunity given to us by Almac and their new initiative. These resources will help make understanding Climate Change real for our pupils in Primary 6.

“It’s fantastic to see a local business supporting our community with real practical learning opportunities for our children. It will also support us across the range of activities we need to complete as part of our eco flags accreditation.”

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Almac Group releases 2024 Sustainability Report

thomasdrake — Tue, 10 Dec 2024 09:00:00 +0000

The Almac Group has today announced the release of its 2024 Sustainability Report which outlines Almac’s ongoing commitment to their people, the planet and the communities where the Group operates, through sustainable practices, community engagement and ethical business operations.

One of Almac’s core objectives is to support, develop, and reward its global workforce of over 7,500 people. The group recently announced that each employee will receive an additional day of leave. This ‘Diversity Day’ can be used to celebrate diversity, to volunteer or take part in community work.

During the last year, Almac Group has supported 60 different charities through global philanthropy and reaching more than 17,000 post-primary pupils through in-person and virtual outreach programmes.

The transition to renewable energy has been a key part of Almac’s journey to net zero over the last year, having announced a virtual power purchase agreement (vPPA) with a wind farm to provide electricity for its Craigavon headquarters. 95% of the electricity consumed at Almac’s Craigavon campus comes from renewable sources, representing a 46% reduction in global scope 2 emissions.

In August 2024 Almac successfully completed the ISO 14064 -1 verification. This emphasises Almac’s dedication to environmental sustainability and transparency through accurate and reliable reporting of greenhouse gas (GHG) emissions.

The report also highlights that Almac is now zero waste to landfill in the facilities where 80% of employees are based.

Alan Armstrong, Chairman and CEO, Almac Group said: “As we support our partners in delivering life-saving medicines across the globe we are conscious of our impact on the people and world around us”

“The achievements in this report reflect Almac’s commitment to advancing human health through the work we do for our clients but also the part we play in ensuring a more sustainable future. The progress made towards our goals this year is thanks to the dedication of our people who I am truly honoured to work with each and every day.”

Read the full report here – Almac Sustainability Report 2024

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Almac announces key partnership with Future Medicines Institute

thomasdrake — Wed, 04 Dec 2024 16:45:41 +0000

The Almac Group has been announced as one of the key industrial partners involved in the launch of the Future Medicines Institute (FMI).

This £55 million industry-led collaborative initiative, backed by a consortium of leading companies in Precision Medicine is also supported by leading academics from Queen’s University Belfast and Ulster University.

Almac’s significant involvement in the new Institute, for Almac Discovery and Almac Diagnostic Services in particular, is a further demonstration of our commitment to the Life and Health Sciences Sector locally.

The FMI will also focus on skills development, leveraging the local universities and colleges to address talent gaps in the sector, foster spinouts, and drive job creation to support the broader Northern Ireland economy. This will further help to build on Almac’s existing track record of investing in the area of skills, whether through STEM engagement, apprenticeships, placements and work experience.

Alan Armstrong, Chair and CEO of Almac Group said: “Congratulations to colleagues in Almac Discovery, Almac Diagnostic Services and Group for the central role they have played in today’s announcement of the £55m Future Medicines Institute. We look forward to working with our other industrial partners and the two universities to deliver on the potential for the life and health sciences sector that the Strength in Places project and the FMI represent for NI.”

The industry-led consortium has been offered £35m from the Northern Ireland Executive towards FMI, with the consortium members contributing an additional £20m. This will fund a wide range of collaborative R&D activities between the companies and universities. It will also create a shared lab within Queen’s University Belfast, where industry and academics can come together to collaborate and access leading edge technologies.

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Almac’s Singapore facility secures GMP Certification

brendanhagan — Thu, 07 Nov 2024 10:43:35 +0000

Almac Clinical Services’ facility in Singapore has received Good Manufacturing Practice certification from the Health Sciences Authority, for cell, tissue and gene therapy products.

This certification demonstrates our commitment to upholding the highest standards of manufacturing quality systems. Clients can be confident that their clinical trial materials, from small molecules to next generation CGTs – are consistently produced and controlled according to relevant GMP standards.

During the inspection in May, the HSA confirmed that Almac’s Singapore facility was compliant with the principles and guidelines of GMP. We recently completed a significant investment to enhance cold chain facilities that will quadruple the site’s existing floorspace and enhance Almac’s capabilities in managing temperature-sensitive clinical supplies. This investment combined with our new certification gives sponsors unparalleled opportunity to maximise success for their next generation therapy trials.

For more information, please contact one of our team here, alternatively you can email info@almacgroup.com.

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Almac Pharma Services announces recruitment event following major expansion at Craigavon HQ

thomasdrake — Mon, 28 Oct 2024 14:33:39 +0000

Almac Pharma Services, is hosting a recruitment event at the Crowne Plaza Hotel, Belfast on 25th November from 4pm to 7:30pm.

Almac is actively recruiting for over 30 roles to suit people no matter what their qualifications or experience. All of the jobs offer a competitive salary and huge potential to progress in a rewarding and varied career.

The recruitment event will give prospective applicants the opportunity to learn more about the work of Almac Pharma Services and an insight into the company’s culture from managers and team members. HR representatives will also be on hand to provide advice on completing the application form and to discuss the benefits and progression pathways that exist within Almac.

Available roles include Technicians, Specialists and Team Leaders within the Production, Operations, Analytical and Quality teams as well as Formulation Development and Technical Specialist roles within its Scientific, Engineering, and Technical departments. The company is also looking for individuals with previous project management experience for a variety of rewarding roles across its multiple client-facing departments.

Mark English, VP Operations at Almac Pharma Services commented: “This is a fantastic opportunity for individuals to join our growing team and contribute to our mission of advancing human health. With the recent expansion of our facilities, we are excited to offer a wide variety of roles that cater to a huge range of individuals regardless of their qualifications and experience. We look forward to welcoming prospective applicants and showcasing the rewarding career paths available within Almac.

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Almac chemist recognised as “Future Leader” at CPHI Celebration Awards 2024

thomasdrake — Wed, 09 Oct 2024 07:11:24 +0000

Dr Megan Smyth wins award for rising stars bringing fresh approaches in the pharma industry

Almac Sciences, a member of the Almac Group, is delighted to announce Dr Megan Smyth, Senior Team Leader, Custom & Flow Chemistry, has been recognised with the Future Leader award at the 2024 CPHI Celebration Awards.

The inaugural award, announced at The CPHI Celebration ceremony in Milan last night, recognises pharma leaders of the future who are bringing a fresh approach to the industry via evidence-based examples of leadership & collaboration, external recognition, personal brand and industry involvement. For more than 20 years, the CPHI Pharma Awards have celebrated innovators making a difference – individuals, teams and companies who are breaking new ground and driving the industry forward.

Megan’s success was demonstrated through her role as Senior Team Leader within Almac Sciences’ Custom & Flow Chemistry team, where she has shown strategic leadership in the further development of Almac’s flow chemistry capabilities, including the establishment of a commercially viable manufacturing platform. Over the past five years, Megan has been an integral part of Almac’s flow team, generating revenue to meet ambitious growth targets, thus adding significant value to Almac’s business. The judges noted that Megan stood out as an emerging talent who had demonstrated the introduction of new ideas, inspired her colleagues and contributed to the broader industry through collaborations, conferences and scientific journals.

In 2022, Megan also won a highly competitive UK Research and Innovation (UKRI) Future Leaders Fellowship (FLF). The R&D grant, worth £1.5 million, funded over a 4-year period, has been enabling further enhancement of innovative continuous manufacturing.

Megan commented: “I am thrilled to receive this inaugural Future Leader award from CPHI. To be globally recognised for my contributions to the pharmaceutical industry as a Future Leader is a huge honour. The implementation of flow chemistry continues to be hugely impactful within the pharmaceutical industry and I am excited to see what the future brings for me, my team and Almac Sciences.”

Prof Tom Moody VP Technology Development & Commercialisation added “Congratulations to Megan for winning this award. Megan is the most worthy recipient and has been instrumental to the growth of our flow chemistry expertise. A Future Leader award is a well deserved merit for all of her achievements to date and I wish her continued success at Almac.”

Visit Almac at CPHI Milan from 8 – 10 October at stand 7C2.

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Almac Group announces £11m investment to expand global analytical services

evewallace — Tue, 01 Oct 2024 08:00:00 +0000

Almac Group, the global contract development and manufacturing organisation (CDMO), has today announced an £11m investment and the creation of over 100 new jobs to expand global analytical services capabilities.

Over the past 18 months, Almac Sciences, which provides development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API), and Almac Pharma Services, which specialises in pharmaceutical drug product development, manufacture and commercial services, have jointly made this significant investment to expand their existing analytical laboratories, technology and resource to meet ongoing global demand.

Almac employs over 700 highly skilled analysts working in regulatory approved GMP laboratories across five locations in Craigavon, UK; Charnwood, UK; Souderton, Pennsylvania; Athlone, Ireland and Dundalk, Ireland. Construction of new laboratory space at the company’s global HQ site in Craigavon considerably increases overall capacity, whilst additional upgrades and development of existing labs across all sites means Almac will seek to increase its existing global analytical employee headcount by over 100 in the next 12 months.

With more than 55 years’ experience, Almac supports drug substance and drug product analytics across all phases, from early phase pre-clinical / clinical development to commercial release. The company typically develops over 1,000 analytical methods and validates over 250 analytical methods each year. Their expert teams offer a comprehensive end-to-end suite of analytical testing for a range of product types including small molecules, peptide, biologics, conjugates, potent and controlled substances.

Almac has added a significant number of specialised instrumentation and techniques across several service lines including chromatography, spectroscopy and biologics. The recent introduction of the Raman TRS100 system also offers clients a faster array of tablets, capsules and other dosage forms. Additional investment in physical sciences equipment (XRPD, PSD, TGA and DSC) provides enhanced capability to support the company’s new spray drying offering from its Charnwood site.

A multi-million-pound digitisation upgrade across all sites, including further investment in Almac’s existing laboratory information management system (LIMS), highlights the company’s ability to seamlessly share information across multiple teams, departments and facilities offering clients a reliable, optimised and streamlined solution.

As part of its ongoing outreach programme, Almac has invested heavily in continuous training and development of its analytical experts. The teams also work closely with local academia to promote and develop a pipeline of talent by providing apprenticeship placements throughout the year.

Darren Thomas, Vice President Analytical Operations, Almac Sciences, commented: “We have experienced a significant increase in demand for our dedicated analytical solutions and recognise the importance of continually investing, not just in our systems and facilities, but also in our people. We are committed to offering a best-in-class service to our global client base and are delighted to continue at pace with significant investment across our UK, EU and US facilities in order to strengthen our competitive position in the marketplace.”

Trevor Clarke, Vice President Analytical Operations, Almac Pharma Services added: “We are positioned as the partner of choice with significant experience in a wide range of analytical services to meet the varying requirements of our clients’ unique development and commercial programs. As we continue to expand our global analytical capabilities, we remain committed to delivering excellence. This significant investment in innovative technology, skilled talent, and state-of-the-art laboratories underscores our dedication to providing comprehensive analytical solutions for our clients worldwide.”

Today’s announcement is part of Almac Group’s £400 million investment to ensure Almac remains global leaders in the industry, giving clients, and ultimately patients across the world who benefit from these therapies, the best possible range of solutions.

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Almac Pharma Services Appoints New VP Finance

brendanhagan — Mon, 30 Sep 2024 12:00:00 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has announced the appointment of Samantha Fitzpatrick as its Vice President of Finance.

As part of Almac Pharma Services’ executive leadership team, Samantha will oversee financial planning, analysis and accounting. In addition, she will collaborate with global department heads to progress a business partnership approach aimed at transforming financial reporting and systems to enhance availability and clarity of financial information. This will facilitate improved decision-making across all aspects of the organisation and support the next phase of growth for the organisation.

Samantha holds a BA (Hons) in Accounting and is a member of the Institute of Chartered Accountants Scotland (ICAS). She has over 15 years of experience in financial leadership roles within Fast-Moving Consumer Goods (FMCG) organisations, including Irwin’s Bakery and Moy Park. She has a proven track record in supporting strategic business growth and joins Almac from Finnebrogue Artisan where she served as Deputy Chief Financial Officer and Financial Controller.

“We are delighted to welcome Samantha to the Almac Pharma Services executive team,” commented John McQuaid, President and Managing Director, Pharma Services. “Samantha’s extensive experience, skill set and leadership will be instrumental in guiding Pharma Services through our next phase of growth. We look forward to the positive impact she will undoubtedly bring to our business.”

The appointment comes just months after Almac Pharma Services announced the completion of a custom-built, high-volume facility significantly increasing its commercial manufacturing and packaging capacity, forming part of the Group’s ongoing global expansion investment programme totalling £400m.

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Arran Chemical Company celebrates 40 successful years in business

brendanhagan — Tue, 24 Sep 2024 08:00:00 +0000

Twenty-million-euro investment by Almac Group trebles chemical company’s revenues and innovative services

Arran Chemical Company (Arran), a member of the Almac Group, is celebrating 40 years in operation.

Originally founded in 1984 by Dr Anthony Owens, Almac acquired the company in 2015 to combine its biocatalysis and flow chemistry expertise with Arran’s large scale manufacturing capacity to improve production processes while enhancing sustainability.

Arran has grown significantly under Almac’s ownership – having invested over €20 million to date, revenues have more than trebled and employee numbers have grown from 45 to 125 people. Further planned facility and capacity expansions will support growth and meet future client demands.

Arran is a named manufacturer of key building blocks that go into over 30 different commercial drugs ranging from products that are used to treat hypertension, cardiovascular issues, renal problems and epilepsy among others. As well as life-changing pharmaceutical products, Arran manufactures aroma chemicals for the fragrances industry used in high-end perfumes and personal performance applications. Arran also manufactures a range of fine chemicals used by the contact lens sector.

Dr. Stephen Barr, President and Managing Director of Almac Sciences said: “We are delighted Arran has reached this operational milestone and are proud of our global reputation for excellence built over these 40 years.

“Our success and ability to provide first class service has only been made possible by the dedication of our exceptional employees, and we pay tribute to their work as we reflect on this milestone. As we look to an exciting future, we wish to thank everyone who has played their part in our story so far. So, to our employees, clients, suppliers and other key stakeholders, thank you.”

Professor Tom Moody, VP Technology Development and Commercialisation for Arran added: “Arran has engaged and thrived in chemical manufacturing for 40 years and continues to innovate in this space through the development of new technologies and subsequent deployment at production scale.

“Almac’s continued investment has allowed us to future-proof the business and we are excited about the years to come. I also echo my thanks to our great team in Athlone, our clients and key stakeholders. We look forward to reaching new milestones and making further advancements across the business.”

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Almac Pharma Services Joins European Paediatric Formulation Initiative (EuPFI)

thomasdrake — Fri, 30 Aug 2024 08:00:00 +0000

Charnwood, UK – 30 Aug 2024 – Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, is proud to announce it has become a member of the European Paediatric Formulation Initiative (EuPFI).

EuPFI is a consortium dedicated to formulating better medicines for children. Their workstreams focus on critical aspects of pediatric formulation development, including age-appropriate formulations, administration devices, taste masking, pharmaceutical excipients, and biopharmaceutics.

As part of EuPFI, Almac Pharma Services’ can contribute to improving access to paediatric medicines by sharing their expertise in this field and collaborating with other industry, academic and regulatory expert partners to identify innovative solutions to the challenges associated with developing medicines for children. By aligning with EuPFI’s mission, Almac will continue its contribution to improving pediatric healthcare worldwide.

Prof Catherine Tuleu, EuPFI’s Founder, added: “We are delighted to partner with Almac to advance ‘little humans’ health! Their unique tailor-made pharmaceutical development and commercial solutions towards paediatric & age-appropriate formulations, as well personalised medicines, is a welcome synergistic addition to our consortium.”

Terry Ernest, Director of Manufacturing Science and Technology, Almac Pharma Services, commented “With over 55 years development experience across Almac, our experts specialise in the design, development, manufacture and packaging of age-appropriate drug products. Becoming a member of the EuPFI enables us to contribute meaningful insights and collaborate with other members as we work together to advance pediatric medicine.”

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Almac Announces Investment in Singapore to Enhance Cold Chain Facility for Global Pharmaceutical Sponsors and Patients

brendanhagan — Tue, 30 Jul 2024 08:00:00 +0000

Almac Clinical Services has announced a significant investment to develop a new frozen facility in Singapore which will quadruple the existing facility’s floorspace and provide an additional 480 storage locations.

This strategic investment aims to enhance Almac’s service offerings in the APAC region, ensuring that global pharmaceutical sponsors receive optimal support across their clinical supply chain.

This development will expand the existing infrastructure to accommodate both production and logistics activities. The state-of-the-art facility will operate at temperatures ranging from -25°C to -15°C and will include a dedicated secondary production room with frozen conditions, further enhancing Almac’s capabilities in managing temperature-sensitive clinical supplies.

Almac is also expanding its range of global secondary clinical supply packaging and temperature-controlled clinical supply and logistics services. These enhancements will support industry trends and the growing demand for advanced cold chain management solutions.

Commenting on the investment Kevin Cheong, Director of Clinical Operations at Almac Clinical Services, said: “The growth of biologics and the complexities surrounding their development and use, necessitates continuous improvement. Biologics are highly sensitive to environmental conditions, including temperature, light, pH, and oxygen levels. Even minor deviations can lead to significant changes in the stability efficacy, and safety of these products.

This investment will significantly enhance our ability to support our global pharmaceutical sponsors and underscores our dedication to providing the best service offering to clients, ensuring that patients receive the right drugs, at the right time and in the right condition.

Our commitment to advancing human health drives us to continually improve all our services and infrastructure. Securing the best possible outcome for patients worldwide is the reason we Supply with Care™.”

For more information about Almac and its comprehensive clinical services, please visit www.almacgroup.com/clinical-services.

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Almac Pharma Services Announces Successful FDA Inspection at Charnwood, UK Facilities

brendanhagan — Tue, 23 Jul 2024 08:00:00 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, is delighted to announce the successful completion of its first US Food and Drug Administration (FDA) inspection of its commercial manufacturing facility in Charnwood, England.

The pre-approval inspection which took place over the course of five days was in relation to a solid oral dose product which the site will manufacture for a global pharmaceutical company. On completion, the inspector concluded the facility, systems and practices comply with FDA requirements with no Form 483 observations or comments reported.

Since its acquisition in 2015, Almac Pharma Services’ facility, which is set within the Charnwood Campus in Loughborough, has experienced significant growth and now employs over 250 highly skilled and experienced individuals. The site provides a wide range of oral dose development and manufacturing specialising in high potency and age-appropriate treatment options.

This successful FDA inspection marks a significant milestone as it represents the final Almac Pharma Services’ site to receive FDA approval. This achievement now complements the existing FDA-approved facilities at the company’s global headquarters in Craigavon, Northern Ireland, Dundalk, Ireland, and its US facility in Audubon, Pennsylvania. It also further reinforces the company’s commitment to upholding the highest standards of quality as it experiences significant growth across its product development, manufacture and commercialisation services to meet ongoing client needs.

Almac Pharma Services’ Vice President, Quality, Ian Markwell commented: “This milestone underscores our commitment to maintaining the highest quality standards and regulatory compliance enabling us to consistently deliver best-in-class services to our clients. With this achievement, we continue to strengthen our position as a trusted, reliable and stable partner as we work together to advance human health for the sake of patients in need.”

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Almac Group’s power purchase agreement for renewable energy goes live

brendanhagan — Thu, 18 Jul 2024 08:00:00 +0000

Almac will reduce carbon emissions from electricity consumed at Craigavon headquarters by 95% through wind power purchase agreement

Niall Harkin, Executive Director, Almac Group

Almac Group has announced that it is now actively sourcing electricity generated by the newly constructed Murley wind farm, located in Co. Tyrone, as part of their 15-year virtual power purchase agreement (VPPA), which was signed earlier this year. The agreement will reduce carbon emissions by over 95% from electricity consumed at Almac’s Global HQ in Craigavon, as almost all of the site’s electricity will ultimately be generated by the windfarm.

Almac’s share of the wind project will deliver 34GWh of renewable electricity annually. Murley, owned by NTR Renewable Energy Income Fund II, is a 21.6MW windfarm with six wind turbines.

This reduction in Almac’s carbon footprint represents a significant step in the Group’s progress towards its carbon reduction goals.

“We are delighted that this project is now operational and that our Craigavon site is now being powered with fully certified electricity from renewable energy,” said Niall Harkin, Executive Director, Almac Group. “This project is a crucial step on our journey to net zero and will significantly reduce carbon emissions from the electricity we consume.

“I am hugely encouraged by the progress that we are making on our climate journey and proud to mark this significant milestone we announce today.”

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Almac Pharma Services Supports Rapid Launch of BioLineRx’s APHEXDA® (motixafortide)

brendanhagan — Tue, 18 Jun 2024 08:00:00 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has successfully supported the commercial packaging and rapid launch of BioLineRx’s APHEXDA® (motixafortide) into the US market.

APHEXDA®, which is administered by injection, was approved on 11 September 2023 by the U.S. Food and Drug Administration (FDA) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

Multiple myeloma is an incurable blood cancer that affects plasma cells, a type of white blood cell found in the bone marrow. It is estimated that more than 35,000 people will be diagnosed with the disease and 13,000 will die due to the condition in the US in 2023, according to the American Cancer Society. The symptoms of the disease include bone pain or fracture, low red blood cell counts, fatigue, high calcium levels and kidney problems or infections.

A multi-departmental team comprised of specialists from Almac’s New Product Introduction (NPI), Planning, Quality Control, Quality Assurance and Artwork departments collaborated with the BioLineRx team to gain a full understanding of the product, approval timelines, various considerations, handling and distribution requirements.

Leveraging Almac’s expertise and experience in launch programmes, the teams worked in true partnership to assess various launch models and together agreed a tailored framework to efficiently, and effectively prepare, label and pack the treatment for immediate distribution upon FDA approval ensuring patients’ needs were met on time.

Asaf Aloni, VP Global Supply Chain, BioLineRx commented: “We engaged with Almac Pharma Services about a year before the expected launch. Almac’s teams worked tirelessly and professionally to help BioLineRx launch successfully on the date set by the company. Almac’s true strength lies in its employees and their dedication to help clients achieve their goals.”

Grainne Hughes, VP Business Support Operations, commented: “Congratulations to BioLineRx on this fantastic achievement. We are pleased to have shared our knowledge and experience with the team to enable the successful rapid launch of this much needed therapy to patients in the US. We wish BioLineRx continued success as we look forward to developing our partnership to supply many more patients in the years ahead.”

Almac Pharma Services’ reliability and commitment to partnering to advance human health is most visible through key partnerships with companies such as BioLineRx, who are working to advance life-changing treatments and therapies to patients.

As part of the Group’s ongoing global expansion investment totalling £400m, the company recently announced the completion of a 32,000 square feet custom-built high-volume facility that significantly increases its existing commercial manufacturing and packaging capacity.

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Almac Pharma Services Appoints New VP of Business Development

thomasdrake — Tue, 04 Jun 2024 08:00:00 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has announced the appointment of Simon Wright as its new Vice President of Business Development.

In his new role, Simon, who holds a BSc in Chemistry, will oversee Almac Pharma Services’ global business development and marketing strategy, in addition to supporting the Senior Leadership team in managing strategic business relationships with existing clients and developing opportunities to drive growth and market expansion for the business.

With a career spanning 30 years, Simon brings a wealth of experience in global business development, strategic leadership, and client relationship management. Most recently, Simon held the position of Head, Global Commercial Operations for Argenta where he was responsible for the management of new and existing customer relationships. Prior to this, he spent over 2 decades with Catalent where he held various senior business development roles and executed effective strategies for building strong relationships with internal teams and customers.

Welcoming Simon to the role, John McQuaid, President and Managing Director, Almac Pharma Services said, “We are delighted to have Simon on board. His experience, coupled with his deep industry knowledge and proven track record of developing successful partnerships, is a vital addition to our senior leadership team. We look forward to working with him as, together, we drive continued growth and success for Almac Pharma Services.”

The appointment comes just 2 months after Almac Pharma Services announced the completion of a custom-built, high-volume facility significantly increasing its commercial manufacturing and packaging capacity, forming part of the Group’s ongoing global expansion investment programme totalling £400m.

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Almac Discovery nominates ALM-401 as a First in Class Bispecific Next Generation ADC targeting EGFR/ROR1 to progress into pre-clinical development

thomasdrake — Thu, 30 May 2024 11:00:00 +0000

Almac Discovery, a research driven drug discovery company and member of the Almac Group, has today announced the nomination of a new pre-clinical candidate molecule (ALM-401), a First in Class Bispecific Antibody Drug Conjugate (ADC) for the treatment of refractory lung cancer, characterised by dual expression of ROR1 and EGFR.

ALM-401 has demonstrated an excellent preclinical efficacy profile in a range of models when benchmarked against clinical stage ROR1 targeting ADCs, as well as strong preclinical development potential.

The bispecific nature of ALM-401 enhances both the activity and selectivity of the product relative to monospecific drug conjugates, delivering sustained regressions in a series of NSCLC PDX models, and with a consistently improved efficacy profile relative to a clinical stage monospecific ROR1 targeting ADC. ALM-401 has a pleiotropic mechanism of action: in addition to direct tumour cell-killing, it blocks EGFR-mediated signalling and induces bystander killing for increased therapeutic activity. The architecture of ALM-401 has been designed to be half the size of a conventional ADC to promote improved tumour penetration and ease of manufacture.

Dr Graham Cotton, Vice President Protein Therapeutics at Almac Discovery, said: “The nomination of this candidate drug represents a significant value inflection point in the development of our ADC portfolio and an important step forward in our search for new treatments for solid tumours. This molecule has arisen from our strategic collaboration with Elasmogen Ltd, and we are confident that ALM-401 has the potential to progress to a First-in-Class drug which exploits the co-localisation of these clinically validated targets.”

Prof. Tim Harrison, VP Drug Discovery at Almac Discovery, added: “We see the emergence of new ADC formats including bispecific and biparatopic pairings as an important stepping stone in the evolution of ADCs, and are excited about the potential of ALM-401. We are now seeking to identify a partner to accelerate the clinical development of this molecule.”

For further details contact Enda Gribbon (enda.gribbon@almacgroup.com)

Connect with Enda Gribbon to arrange a meeting at Bio 2024, San Diego to discuss the potential of ALM401 for the treatment of refractory lung cancer.

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Almac Group announces record revenue figure resulting from another year of growth

thomasdrake — Tue, 28 May 2024 09:00:00 +0000

Revenue up 14% to £958m with profit at £93.8m

Almac Group, the global contract pharmaceutical development and manufacturing organisation, has today announced its financial results for year ending 30 September 2023.

Figures released show the company recorded a £118 million (14%) rise in revenue, up from £840 million in 2022 to £958 million in the period. Operating profit rose again – final pre-tax profits were recorded at £93.8 million, down slightly from £97 million (3.3%) in the previous year, due to a significant exchange rate adjustment¹.

The numbers released cover the second year of Almac Group’s £400M global expansion plans, announced in November 2021. This global expansion programme announced the creation of 1,800 new roles at Almac. 1,200 of those have already been filled and current Almac Group employee numbers now exceeds 7,300.

Almac is at the forefront of developing, manufacturing, testing and distributing essential medicines to patients around the world. During this financial year the group was involved in the development of hundreds of life-saving drugs spanning more than 20 therapeutic areas including oncology, cardiology, immunology, gene therapy and neurology.

Alan Armstrong, Almac Group Chairman and CEO said: “We are a privately-owned and independent company, committed to re-investing all our profit back into the business. We continuously innovate and expand our business offerings, enabling us to support our clients while advancing human health.

“Today’s announcement is a welcome continuation of growth for the Almac Group, and I would like to thank everyone within the organisation for playing their part. Our valued global workforce is Almac’s greatest asset providing the foundation for our success.

“Almac is dedicated to ensuring we remain a global leader in our industry, giving our clients and ultimately patients across the world the best possible offering. We continue to play our part as a valued and trusted member of the communities in which we operate.”

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Almac Pharma Services Supports Industry Consortium to Address Titanium Dioxide Alternative Challenge

brendanhagan — Tue, 30 Apr 2024 08:56:20 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has announced the completion of multiple assessments in support of a global pharmaceutical industry Consortium to help address the challenge of titanium dioxide (TiO₂) usage in drug products.

With over 50 years’ experience in product development and an established reputation for oral dose formulation expertise, Almac Pharma Services was selected by the Consortium to support the critical investigation into TiO₂-free systems with the aim of future proofing the delivery of safe and effective solid oral treatment supply to patients in need.

Due to its unique properties, TiO₂ has been used as a colourant, opacifier and for protection from UV radiation on solid oral dosage forms for decades. In 2022, following an assessment by the European Food Safety Authority (EFSA), the EU commission banned TiO₂ from use in food but allowed its ongoing use in medicines upon the recommendation of the EMA, with a further review scheduled for April 2024. The European Commission is expected to make a final decision on the ban in February 2025 following the update EMA assessment^[1].

To coordinate activities and deliver an industry-aligned assessment, a grouping of (>20) industry leading pharmaceutical companies was formed in 2022 to collectively address this via a new pre-competitive industry Consortium. The aim of the ‘Alternatives Consortium’ was to generate evidence that can be used by the EMA to support the re-evaluation of the feasibility of removing TiO₂ from the list of excipients for use in medicines.

In preparation for the pending EMA review, the time sensitive project was initiated in March 2023 and members of the Consortium provided a full brief of the requirements. In true partnership with key members of the group, Almac’s scientific experts conducted multiple assessments with respect to the processibility and manufacture of TiO₂-free options based on their effectiveness, impact on product and general technical feasibility.

Upon completion of the 12-month investigation involving a significant volume of testing, and meeting all key milestones throughout the project, Almac provided a comprehensive range of observations and significant data sets enabling the Consortium to submit their final report to the EMA.

Alan Carmody, TiO₂ Alternative Consortium, experimental and data interpretation work stream lead: “When the consortium approached Almac we set out a significant challenge to evaluate 34 different film coat systems and 17 hard shell capsule systems. Almac accepted the challenge and have been excellent partners showing resilience and flexibility to meet our requirements and produce the comprehensive data package we required for our submission to the EMA.“

John McQuaid, President & Managing Director, Almac Pharma Services commented on the partnership: “We recognised the enormous challenge a potential ban on titanium dioxide usage could have for many products across the industry. Being able to partner with a global Consortium to support this crucial investigation into suitable TiO₂ alternatives has been incredibly rewarding for our teams as we worked together to find a solution to safeguard patients now, and in the future.”

Last month, Almac Pharma Services announced the completion of a custom-built, high-volume facility significantly increasing its commercial manufacturing and packaging capacity, forming part of the Group’s ongoing global expansion investment programme totalling £400m.

[1] https://www.raps.org/News-and-Articles/News-Articles/2023/11/Pharma-groups-fight-proposed-ban-on-titanium-dioxi

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Almac Group partners with Reach Out and Read at Children’s Hospital of Philadelphia to distribute 6,000 books at CHOP Primary Care, Souderton

thomasdrake — Tue, 23 Apr 2024 13:00:00 +0000

Funding by Almac will help distribute thousands of books to local families during well-child visits at CHOP Primary Care, Souderton location

In celebration of World Book Day this April 23, Almac Group is pleased to fund Children’s Hospital of Philadelphia’s (CHOP) award winning, national Reach Out and Read programme serving the Primary Care, Souderton location for one year, effective immediately.

Almac’s backing will allow Reach Out and Read at CHOP to procure 6,000 books to be distributed by medical providers at CHOP Primary Care, Souderton to all patients ages newborn to five during well-child visits. As an early literacy intervention programme, the Reach Out and Read model enables physicians and nurse practitioners to use the books as a developmental surveillance tool during well-visits and as a springboard for conversations with parents about the importance of reading aloud, all while building home libraries for children no matter their financial resources.

As a celebration of World Book Day and the launch of this partnership, a volunteer activity at Almac is set for April 23 for employees to help prepare over 1,000 books for the inaugural book delivery.

“Almac is thrilled to promote the importance of equitable access to literacy this World Book Day through our support of Reach Out and Read at CHOP,” said Valarie Higgins, Managing Director and President of Almac Clinical Technologies. “Recognising how vitally important early literacy skills are for childhood development, we applaud CHOP’s incredible efforts to make this award winning programme accessible in Greater Philadelphia.”

“Reach Out and Read’s mission to support healthy brain and social/emotional development in children through reading directly aligns with Almac’s mission to advance human health, as well as our commitment being an enduring example of corporate social responsibility here in Souderton,” added Mark Rohlfing, Vice President of Operations, Almac Clinical Services. “We are thrilled to assist CHOP through this sponsorship to benefit patients in this community.”

“We are so thankful for Almac’s generous donation to Reach Out and Read at CHOP Primary Care, Souderton. The children excitedly anticipate a new book at each well check which develops their love of reading at a very young age,” said Kathy Filograna, MD, Regional Medical Director, CHOP Primary Care Network and Medical Director, CHOP Primary Care, Souderton. “With this donation, our families will have the opportunity to curl up with a good book, read to their children, while expanding their imaginations and developing those important early literacy skills.”

Endorsed by the American Academy of Pediatrics as the sole evidence-based national pediatric programme centred on emotional bonding, Reach Out and Read annually serves more than 4.4 million children in every state across the U.S., delivering services through 6,200 clinics and leveraging the expertise of 36,000 clinicians. Through the CHOP Primary Care Centers, Reach Out and Read will serve at least 93,000 young children, ages newborn through 5 years, and distribute at least 160,000 brand-new, age-appropriate books this year.

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Amicus Therapeutics Inc and Almac Pharma Services Mark 15-year Strategic Partnership with Patient Advocacy Event

admin — Mon, 22 Apr 2024 12:59:41 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has celebrated a key milestone of its strategic partnership with global biotechnology company, Amicus Therapeutics Inc, by hosting a patient advocacy event for its employees.

Almac Pharma Services commenced their relationship with Amicus in 2009 by providing product development and clinical manufacture services and continued its successful partnership as the drug moved into commercialisation after gaining FDA and EMA approval. Almac’s expert teams has now provided fully integrated, end-to-end commercial manufacture, packaging and distribution solutions to Amicus for over 15 years from its Craigavon headquarter facility ensuring reliable and efficient global distribution to meet ongoing patient demand.

To mark the occasion, on 17^th April, Almac Pharma Services welcomed Amicus Therapeutics’ Chief Patient Advocate, Jayne Gershkowitz along with several patient advocates, who shared their experiences of living with a rare disease with Almac’s employees. The two-hour information session offered a unique opportunity for team members from across multiple departments including packaging, distribution, project, quality and engineering to hear, first-hand, from patients about their journey from rare disease diagnosis to treatment and the impact this has had on their lives.

Andrew Harrison, Packaging Team Leader, an Almac Pharma Services employee for over 30 years, attended the event and commented: “This patient advocacy event has given us all the opportunity to learn more about the impact a disease has on, not only the patients, but their families too. Hearing from individuals about their lived experience in this way enables us to gain a deep understanding and appreciate the positive contribution we are making every single day to healthcare.”

Grainne Hughes, VP Business Support Operations, Almac Pharma Services, stated: “We are extremely proud of the strong, global reputation that Almac has built over the last 55 years as a trusted and stable CDMO partner.

“Partnering with the Amicus team to support the ongoing supply of their drug has been hugely rewarding for our team. Knowing that our support is contributing to patient health in this way is clear motivation to ensure we continue to provide best-in-class, tailored services to our clients. We thoroughly enjoy working with Amicus and look forward to our continued partnership.”

Jayne Gershkowitz, Chief Patient Advocate, Amicus, commented: “Celebrating our 15-year partnership with Almac is an important milestone, and a testament to the significance of shared vision in supporting the rare disease community. We are honoured to be part of this event and bring the perspective of patients to Almac to inspire the team to continue its important work of making medicines that improve the lives of people with rare diseases.”

Just last month, as part of the Group’s ongoing global expansion investment totalling £400m, the company announced the completion of a 32,000 square feet custom-built high-volume facility that significantly increases its existing commercial manufacturing and packaging capacity.

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Almac Clinical Services celebrates Grace Science, LLC in dosing first NGLY1 deficient patient with their innovative gene therapy

admin — Thu, 11 Apr 2024 14:04:28 +0000

Almac Clinical Services is proud to celebrate Grace Science, LLC in reaching a critical milestone in their innovative GS-100 gene therapy programme for NGLY1 Deficiency— dosing their first patient in February 2024.

NGLY1 Deficiency is a life-threatening rare autosomal recessive disease with no approved therapy. The disease devastates the central nervous system, causing severe and debilitating symptoms, such as global developmental delay, cognitive impairment, movement disorders, and other neurological symptoms. Grace Science’s gene therapy, GS-100, is an AAV9 single-stranded viral vector that encodes a full-length version of the human NGLY1 gene.

Almac was honoured to support Grace Science in meeting this milestone, which required a fast-tracked dosing schedule to meet a momentous “dosing day” target in late February. The target date was especially significant as it coincided with Rare Disease Day.

Understanding that there was no room for error on the timeline, Almac’s clinical services teams from both the Souderton, PA and Durham, NC facilities sprang into action. Leading up to “dosing day,” the teams worked “all hands on deck” to ensure the high-value gene therapy product made it on time and in the right temperature sensitive condition to the site in Houston, Texas.

“I want to thank all of my colleagues across Almac that worked around the clock to dose patient 1 in Grace Science’s exciting new gene therapy trial,” said Todd Huml, Project Services Manager- Customer Support. “This was a true showing of departments across the company coming together to meet a patient’s need and truly Supply with Care.”

“This trial of a high-value, sub 80 degree gene therapy product has the potential to make a considerable impact on the lives of patients with NGLY1 Deficiency. Grace Science is a passionate partner and we are proud that Almac was able to play a role in this incredible milestone in their journey towards a cure.”

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Almac Pharma Services Appoints New Director of Manufacturing Science and Technology

admin — Thu, 04 Apr 2024 07:58:00 +0000

Craigavon, UK – 4 April 2024 – Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has announced the appointment of Terry Ernest as its new Director of Manufacturing Science and Technology.

Terry has extensive experience within the pharmaceutical development and manufacturing industry, including a deep knowledge of a variety of dose forms including modified release formulations, tablets, capsules, oral liquids and sterile liquids.

A Chartered Biologist with a Masters Degree in Industrial Pharmacy and PhD in Pharmaceutics, Terry joins Almac from GSK where he held a number of senior positions over his 30 year tenure, including his most recent role as Director, Product Development at its site in Ware, UK.

As a subject matter expert in age-appropriate drug development, Terry is a member of several paediatric focus groups in addition to multiple product development industry bodies and has published a number of papers on the topic. He has also been invited to deliver technical presentations at global conferences and industry events throughout the last 20 years.

James Hurst, VP Operations & Charnwood Site Head, commented on Terry’s appointment “We are delighted to welcome Terry to our team of established experts. His vast experience and product development expertise will provide additional technical support to our growing client base. His appointment comes at an exciting time as we proceed with our strategic growth plans by investing in our facilities, technology and our most vital asset, our people, as we continue to offer our clients, and ultimately patients across the world, a best-in-class service offering.”

Terry’s appointment comes just weeks after Almac Pharma Services announced the completion of a custom-built, high-volume facility significantly increasing its commercial manufacturing and packaging capacity, forming part of the Group’s ongoing global expansion investment programme totalling £400m.

#ENDS#

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

Employing over 1,600 highly skilled individuals across 4 locations in Europe and the US, the company provides tailored, quality-led and timely solutions from early and late phase pharmaceutical development, clinical and commercial drug product manufacture, product launch through to commercial packaging and global distribution.

To keep up to date with latest news, follow us on LinkedIn or visit our website.

About Almac Group

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically, now employing 7,200 highly skilled personnel across 18 facilities including Europe, the USA and Asia.

To keep up to date with latest news, follow us on X and LinkedIn or visit almacgroup.com.

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Almac Group announces support of ESG category at this year’s Belfast Telegraph Business Awards

admin — Wed, 27 Mar 2024 15:29:08 +0000

Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle.

Niall Harkin, executive director of Almac Group, commented on Almac’s support for the ESG category in Belfast Telegraph Business Awards.

“Being a responsible business has always been ingrained in our culture at Almac. ESG (environmental, social and governance) is key to how we do business, and it is of growing importance for our clients, our people, and our potential new employees. Now more than ever it is imperative that companies act on ESG.

“Given its rising importance, it’s crucial to acknowledge the changes you need to make, be transparent about the progress made, and then take steps to make the changes happen. We are pleased to support the ESG category at this year’s Belfast Telegraph Business Awards, to recognise a company that has demonstrated excellence in this area with an ambitious ESG agenda right at the heart of its organisation.”

Read the full article here

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Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia

admin — Wed, 20 Mar 2024 14:42:54 +0000

Tonmya™ is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by positive results from two Phase 3 studies

New Drug Application (NDA) submission to the FDA planned for second half of 2024

CHATHAM, N.J., March 20, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced it has selected two contract manufacturing organizations (CMOs), one of which is Almac Pharma Services, a member of the privately owned- Almac Group, as dual supply sources for the potential launch and commercialization of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in the U.S.

‘‘Dual sourcing is a critical element for the successful commercial launch and supply chain management of a product,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We are excited to advance our first internally developed program toward NDA submission and to work with two well-established CMOs for commercial supply and potential launch of Tonmya.”

“Having supported the development and clinical trial supply of this drug, we’re thrilled to be continuing our partnership with Tonix to support the commercial launch and ongoing supply of this important new non-opioid analgesic to patients with fibromyalgia, a chronic debilitating disease.” said Mark English, VP Operations, Almac Pharma Services.

Tonmya is a centrally acting, non-opioid medication. As previously announced, Tonix’s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies, and no new safety signals were observed.

Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2024 for Tonmya for the management of fibromyalgia.

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Almac Sciences awarded Life Sciences Innovative Manufacturing Fund Grant

brendanhagan — Thu, 14 Mar 2024 09:00:00 +0000

Grant awarded to support the expansion of Almac’s small molecule API manufacturing plant

Almac Sciences, a member of the Almac Group, has been awarded a Life Sciences Innovative Manufacturing Fund (LSIMF) Grant to support the expansion of its small molecule active pharmaceutical ingredients (API) manufacturing facility at its Global Headquarters in Craigavon, UK.

The grant will support the installation of the expanded facility, already under construction, which is due for completion in Summer 2025. Once complete, the 30,000 sq ft facility will support small molecule API production at 100s kg to metric tonne scale.

As announced by Jeremy Hunt, UK Chancellor, Almac was one of two UK pharmaceutical companies awarded the grant to support manufacturing expansion projects. The Department for Science Innovation and Technology (DSIT) reopened the LSIMF in 2023 to support businesses investing in manufacturing projects in the UK. Over its lifetime, the fund will provide capital grants for investments in the manufacture of human medicines (drug substance and drug product), medical diagnostics and MedTech products.

Almac Sciences has grown rapidly over the last five years and this expansion is part of a multi-million-pound investment programme to support increased client manufacturing demands. The first stage of Almac’s GMP facility expansion was announced late 2022 with an extension to its current GMP manufacturing facility, and warehouse expansion opened Summer 2023. Increased capacity for peptide API production has just been announced, creating another manufacturing centre of excellence and further supporting the business’ ongoing growth plans.

Dr Daniel Bayston, VP Small Molecule API, said: “As a privately-owned and independent company, we are committed to re-investing all our profit back into the business, allowing us to continuously innovate and expand. We are delighted and grateful to be awarded this grant, assisting us with our ongoing expansion plans.

“Almac has a strong, global reputation, built over the last 55 years as a trusted and stable CDMO partner for the world’s leading biopharma companies. This new manufacturing facility is critical to support the increased demand from our clients and provides us with a stronger ability to serve our global customer base advancing human health.”

Almac has a proven track record and expertise in small molecule and peptide API manufacturing from pre-clinical to commercial scale and has developed long-established relationships from pharma and biotech clients offering comprehensive end-to-end development and manufacturing solutions.

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Almac Group Awarded six 2024 CDMO Leadership Awards

brendanhagan — Tue, 12 Mar 2024 14:30:00 +0000

Almac Group, the global contract development and manufacturing organisation, is delighted to announce that the Group’s Pharma Services and Sciences divisions have, once again, been recognised in all six core categories in this year’s CDMO Leadership Awards programme.

The annual award programme, presented by Outsourced Pharma and Life Science Leader, recognises top performing CDMOs, celebrating outstanding companies in drug development and manufacturing, emphasising high standards of quality, integrity and innovation exemplified in their work. Results are based solely on primary market research by Industry Standard Research (ISR), with winners in each category judged by their customers as either exceeding expectations or as top performers in outsourced projects conducted within the past 18 months.

Almac holds an exceptional record of client service, further underscored by the CDMO Leadership Awards programme and its primary research-driven methodology. The company is a privately owned and independent CDMO that has grown organically for over five decades, now employing over 7,200 and undergoing significant expansion in capacity and technology exceeding £400 million across the globe.

This year, 98 contract manufacturers were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. This experiential feedback was analysed by sponsor company size to reveal leading CDMOs in different performance categories.

Almac was successful in achieving awards in all core categories including:

Capabilities (Small Pharma)
Compatibility (Small Pharma)
Expertise (Small Pharma)
Quality (Small Pharma)
Reliability (Overall, Small Pharma)
Service (Small Pharma)

John McQuaid, President and Managing Director, Almac Pharma Services, commented: “Our mission is to advance human health by providing high quality, end-to-end solutions to our clients and ultimately their patients. Receiving recognition, for yet another year, demonstrates our commitment to excellence in pharmaceutical development and commercial supply services and is particularly significant as we have been assessed by our valued clients.”

Stephen Barr, President and Managing Director, Almac Sciences, added: “Once again, I am delighted and proud that Almac has been recognised by our clients via the Life Sciences CDMO awards. To win in all six categories further endorses our excellence in research, development and manufacturing of high-quality chemical products used in high-profile consumer industries across the globe. We will continue to drive innovation to deliver exceptional science, sophisticated technology and unparalleled expertise.”

Louis Garguilo, Chief Editor and Conference Chair, Outsourced Pharma said: “Drug and therapy sponsors had much to be concerned with the last 12 months or so. There was still supply-chain uncertainty, ever-growing novelty in platforms and processes requiring new skillsets and technologies, and the speed of everything seemed to accelerate. Through it all, CDMOs stayed focused, and also adapted to customer and market needs. Those best at serving their customers (and thus patients) are recognized as the 2024 CDMO Leadership Award winners. CDMOs may not have had all the answers in an uncertain year, but these are the external partners who provided the biopharma industry with the best solutions.”

The company has just announced the completion of two new purpose-built facilities to expand its commercial manufacturing and packaging as well as peptide production as part of its ongoing global expansion investment programme.

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Almac Group Expands Commercial Manufacturing and Packaging as well as Peptide Production Capacity

brendanhagan — Wed, 06 Mar 2024 08:45:59 +0000

Ongoing Global expansion investment now totals over £400m / $500m

The Almac Group has today announced the completion of two new purpose-built facilities at its headquarters in Craigavon, Northern Ireland meeting client demand in commercial manufacturing and packaging as well as peptide production.

The multi-million-pound large-scale expansion substantially grows operations for two of the Group’s business units, Almac Pharma Services and Almac Sciences.

The first of these two major projects is a 32,000 square feet custom-built high-volume facility for Almac Pharma Services that significantly increases commercial manufacturing and packaging of sachet drug product presentations. The investment includes additional large-scale manufacturing suites, automated primary and secondary sachet packaging technologies and also expands the company’s QC Laboratory Testing capacity.

The second project is a 28,000 square feet GMP facility that more than doubles peptide API manufacturing capacity for Almac Sciences. It will enhance synthesis, purification and isolation capabilities and meet anticipated demand for clinical development and commercial products.

These new developments are part of Almac’s global investment programme announced in June 2022. Since the start of the programme Almac has also announced a Centre of Excellence for Commercial Drug Product Partnership; a CDx Development, Manufacturing and Commercial centre; a drug substance GMP facility for clinical and commercial manufacturing; further expansion to clinical production and distribution capabilities in Souderton, Pennsylvania and the launch of cryogenic and ultra-low service capabilities for clinical supply in Durham, North Carolina.

Graeme McBurney, Chief Operating Officer, Almac Group said: “Today’s announcement of continued expansion ensures that we remain the global leaders in our industry, giving our clients and ultimately patients across the world who benefit from these therapeutics, the best possible offering from Almac.

“Our new peptide API manufacturing facility will significantly grow our portfolio of client APIs and is the latest stage of a wider development and manufacturing expansion initiative for Almac Sciences. The business has also recently opened a new technology development centre, installed additional small molecule API GMP reactors, and opened a dedicated chemical warehouse.

“In the drug product service arm of our business, Almac Pharma Services is adding to its large-scale commercial manufacturing and packaging capabilities in response to growing demand for tailored solutions to meet clients’ market growth needs. This allows us to support our clients throughout a drug’s lifespan, from early development through to commercialisation.

“Almac Group believes it is vital to keep growing our capacity and our range of service offerings to meet the growing needs of all our clients now and into the future. I am extremely proud of the strong, global reputation that Almac has built over the last 55 years as a trusted and stable CDMO partner for the world’s leading biopharma companies.

“We are a privately-owned and independent company, committed to re-investing all our profit back into the business so that we can continuously innovate and expand, enabling us to support our clients and together advance human health.”

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Almac Pharma Services Renew HPRA GMP Certification for European Facility

evewallace — Mon, 12 Feb 2024 14:46:40 +0000

Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has received renewal of The Health Products Regulatory Authority (HPRA) Certificate of GMP Compliance for the company’s European facility.

The achievement comes following an in-depth, on-site 5-day audit conducted by an HPRA inspector from 6^th – 10^th November. The certification applies to all labelling, secondary packaging including specialist ultra-low temperature processing, analytical and distribution activities performed at the company’s Dundalk, Ireland facility.

The audit was overseen by Andrew Spence, Almac Pharma Services’ Head of Quality Assurance, and Fiona McDonnell, Dundalk’s Quality Manager supported by multiple subject matter experts from across Almac Pharma Services’ production, warehouse, labs, QP, global QA and technical quality teams.

The multi-departmental collaboration exhibited throughout this regulatory inspection, and our ability to maintain our reputable high standard of on time, in full (OTIF) service levels throughout the week, is testament to the commitment and professionalism of the entire Almac Pharma Services’ team.

Ian Markwell, VP Quality Assurance, Almac Pharma Services, said: “As a trusted partner to hundreds of global pharmaceutical clients we are committed to delivering best-in-class, tailored and quality-led services. The renewal of our HPRA certificate is a clear reflection of how our people, infrastructure, policies, systems and skills combine to achieve excellence for our customers. Thank you to everyone who contributed to the successful outcome of this inspection at our Dundalk facility, and I look forward to continued growth of this site in the coming years.”

Almac Pharma Services’ Dundalk facility is one of four operational sites and is a dedicated Centre of Excellence offering Just-in-Time labelling, packaging and serialisation of all pharmaceutical products including advanced therapeutical medicinal products which are often handled at ultra-low temperatures (-20°C to -80°C).

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Almac Group signs virtual power purchase agreement (VPPA) for renewable energy – reducing their global scope 2 emissions by 46%

brendanhagan — Tue, 06 Feb 2024 09:50:29 +0000

Almac Group today announced a 15-year virtual power purchase agreement (VPPA) with renewable energy provider, NTR plc. to source electricity generated by the newly constructed Murley wind farm, located in Co. Tyrone, Northern Ireland. The agreement will reduce scope 2 carbon emissions by 46% across Almac’s operations globally and by over 95% at Almac’s Global HQ in Craigavon, as almost all of the site’s electricity will ultimately be generated by the windfarm.

Almac’s Craigavon site has undergone significant expansion in recent years with Almac announcing hundreds of £millions of investment in 2022. The campus currently employs over 4,000 of Almac’s 7,000 global workforce supporting pharma and biotech companies in their drug development process.

Almac’s share of the wind project will deliver 34GWh of renewable electricity annually. Murley is a 21.6MW windfarm with six wind turbines currently in late-stage construction and is expected to be operational by July 2024.

This reduction in Almac’s carbon footprint represents a significant step in the Group’s progress towards its carbon reduction goals. Signing this agreement follows a number of recent steps taken by the Group to support their 2045 net zero target. These include joining the Science Based targets Initiative (SBTi) which defines and promotes best practice in science-based target setting.

“We are delighted to partner with NTR on this exciting project which will allow us to power the operations at our Craigavon site with fully certified renewable energy,” said Niall Harkin, Executive Director, Almac Group. “Almac’s participation in this project is a crucial step on our journey to net zero and will significantly reduce carbon emissions from the electricity we consume.

“As a global leader in providing a range of expert services and support across the drug development lifecycle, it is crucial that we demonstrate our commitment to the long-term sustainability goals of the sector. I am hugely encouraged by the progress that we are making on our climate journey and proud to mark this significant milestone we announce today.”

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Almac Sciences extends selectAZyme™ offering to include therapeutic oligonucleotide synthesis

brendanhagan — Thu, 25 Jan 2024 12:00:00 +0000

Synthesis leverages new RNAL Ligase (RNAL) enzyme kit, a focussed library of 10 double stranded RNA Ligase enzymes selected from Almac Sciences’ extended RNAL enzyme panel

Almac Sciences, a member of the Almac Group, announces new capability to synthesize therapeutic oligonucleotides, made possible by the introduction of a new an easy-to-use RNA Ligase (RNAL) enzyme kit that extends the company’s selectAZyme^TM enzyme screening collection.

The kit contains a focussed library of 10 double stranded RNA Ligase enzymes, selected from an extended RNAL enzyme panel, and can be used to make single and double stranded RNA— as described in technical paper by Caswell et al. ACS Chem. Biol. 2023, 18(10), 2183-2187.

This marks the first time that Almac’s award-winning enzyme technology has been applied to therapeutic oligonucleotide synthesis, a class of drug that has rapidly grown in interest due to their synthesis and manufacture. Building upon the strong biocatalytic technology base already available at Almac, this newly available synthesis leverages the company’s selectAZyme™ ligase enzymes to produce both single stranded and double stranded oligo products.

The Ligase panel has the following attributes:

Manufacture of high-quality RNA oligo product using the Almac ligase 3:2:3:2 approach via RNA blockmer assembly,
Activity against both natural and unnatural nucleosides with modifications including 2’F, 2’MOE & 2’OMe modifications and many more,
Enzymes can be immobilised and/or provided with low-endotoxin levels on request,
The enzymes can be used to complement existing oligonucleotide synthesis by combining a biocatalytic approach with existing classical chemical synthesis,

Choosing a complementary biocatalysis route for oligonucleotide synthesis offers many benefits including higher isolated purity of the RNA product, purity enrichment via ligation of the blockmers due to complementarity of base pairing. This technology also allows for convergent synthesis opening up new supply chain opportunities.

Dr Jill Caswell, Biology Senior Team Leader commented “Almac has developed a range of biocatalytic products and services to facilitate the challenges posed in biocatalytic oligonucleotide synthesis and this new RNAL kit has the ability to diversify and strengthen supply chain blockmer manufacture which can often shorten timelines, benefitting our customers greatly. The expansion of our portfolio of product offerings further showcases our commitment to providing our customers with the most innovative and efficient processes.”

The selectAZyme^TM RNA Ligase kit is readily available now and extended panels of double stranded RNA Ligase enzymes are available on request as well as single stranded RNA Ligases.

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Almac Launches Manufacturing and Development Recruitment Drive

brendanhagan — Mon, 15 Jan 2024 13:52:21 +0000

Following recent significant expansion Almac Group is recruiting for a large variety of roles at the company’s global headquarters in Craigavon.

This expansion offers a wide range of opportunities to suit people no matter what their qualifications or experience. There are roles for all – those who do not have a degree, recent graduates and people who are experienced in their field. All of these roles offer huge potential to progress in a rewarding and varied career.

Available roles include Grade 3 Senior Operators, Production Technicians, Production Specialists and Production Team Leaders within the Production and Operation teams as well as Formulation Development and Technical Specialist roles within our Scientific, Engineering and Technical teams.

The company is hosting an information day at the Seagoe Hotel, Portadown on Tuesday 6th February from 12pm and 8pm to give prospective applicants the opportunity to hear more about the roles and speak to managers and current team members. HR representatives will also be on hand to provide advice on completing the application form and to discuss the benefits and progression pathways that exist within Almac.

Tom Hegarty, Head of Technical Operations at Almac Pharma Services, said: “We are pleased to be recruiting for a range of roles to support our growing global business and continue to meet increasing client demand. We look forward to welcoming new colleagues who can make a meaningful contribution to the development and delivery of life-saving treatments and help us in our mission to advance human health together.”

To find out more about the roles or register for our recruitment event visit:

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Almac Group awards over $120,000 in higher education funding to two undergraduate students

brendanhagan — Thu, 30 Nov 2023 09:08:24 +0000

Group renews commitment to reducing educational barriers in communities local to US- based facilities in Philadelphia, PA and Durham, NC

This National Scholarship Month, Almac Group announces that the Almac Group Scholarship programme has been extended to award over $120,000 in funding to two recipients in Philadelphia, Pennsylvania and Durham, North Carolina.

Almac Group’s needs- based scholarship awards are valued between $45,000- $80,000 per recipient and are distributed across four years. With the average college debt sitting at over $30,000 per student in the United States, Almac developed this award programme in 2021 through partnerships with the Triangle Community Foundation and Philadelphia Education Fund to make a considerable, measurable impact on the life of its recipients.

Applicants must be first generation college students and live in the communities local to the Group’s US-based facilities in Pennsylvania and North Carolina.

In Pennsylvania, the 2023 recipient is Daniarkos Pierre of Philadelphia. Daniarkos is a graduate of Olney High School and the Philadelphia Education Fund’s College Access Program. She is currently studying biology at Montclair State University.

In North Carolina, the 2023 recipient of the Almac award is Monserrat Elizalde Martinez of Durham. Monserrat is a graduate of Josephine Dobbs Clement Early College High School and is studying mechanical engineering at North Carolina State University.

In addition to tuition and fee assistance, recipients will have the opportunity to develop a meaningful relationship with Almac Group during their undergraduate study, gaining exposure to the organisation’s role in the global pharmaceutical and biotech industry.

“We are delighted to announce that Almac has extended our partnership with the Triangle Community Foundation and the Philadelphia Education Fund to recognise and award two additional students from our local communities this year,” commented Alan Armstrong, Almac Group Chairman and CEO.

“At Almac, it is one of our core values to give back to the communities in which we operate. Our successful scholarship programme has allowed us to not only financially support local students in their educational ambitions, but also to welcome them to Almac for meaningful experiences. We congratulate both Monserrat and Daniarkos for all of their success and achievement thus far and look forward to supporting their educational ambitions over the next four years.”

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Almac Discovery and Queen’s University launch state-of-the-art Chemoproteomics facility in Belfast

brendanhagan — Wed, 29 Nov 2023 11:30:00 +0000

Almac Discovery and Queen’s University Belfast have today announced a five-year project to develop a new Chemoproteomics Centre of Excellence for drug discovery.

The multi-million-pound facility, which is jointly funded by Almac Discovery and a BBSRC Prosperity Partnership award, is a first of its kind in Northern Ireland and will be located at Queen’s.

The project combines and harnesses the experience of industrial and academic experts to shine a new light on the way drug molecules could be used to treat disease, by using advanced mass spectrometry techniques to examine their effects on thousands of potential drug targets simultaneously, in disease relevant systems.

This latest collaboration builds on a long-established relationship between Almac Discovery and Queen’s in biological research and early-stage drug discovery. It will leverage the capabilities and state-of-the-art expertise of Queen’s researchers in mass spectrometry and biological research across three Queen’s University research centres.

Securing a Prosperity Partnership award for this project highlights the importance of advanced proteomics in addressing drug discovery challenges which will ultimately make a difference to people’s lives.

Professor Tim Harrison, Vice President of Almac Discovery said: “Creating this industry-facing, university-based facility represents a unique opportunity to provide a step-change in proteomics-based experimental capabilities in Northern Ireland.

“Our vision is to build an internationally recognised resource comprising chemical probes, experimental capabilities, and proteomics expertise which will accelerate the research and development programmes of regional, national and international industrial and academic partners.”

Professor Christopher Scott, Dean of Research, Faculty of Medicine, Health and Life Sciences, Queen’s, said: “We are delighted to see this new exciting initiative which will drive the research capabilities of both Queen’s and Almac. Our vision is that this Centre of Excellence will become a national asset that can help support broader research and education pipelines nationally”.

The Centre of Excellence will also enhance Northern Ireland’s drug discovery research capabilities, providing skills training for apprenticeships through to doctoral researchers.

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Almac Pharma Services Receives Brazilian ANVISA GMP Certification for US Facility

brendanhagan — Tue, 14 Nov 2023 13:07:16 +0000

Almac Pharma Services, a member of the Almac Group providing product development, manufacturing and commercial services to global pharmaceutical and biotech organisations, has received its ANVISA GMP Certificate for the company’s Pennsylvanian facility, which approves the site for supply of products into Brazil.

An ANVISA GMP certificate is issued by the Brazilian Health Regulatory Agency (ANVISA) to confirm that an establishment complies with the technical requirements of Good Manufacturing Practices (GMP) needed for commercialising a product, according to the current law.

The facility, located in Audubon, is an established, FDA approved site offering a range of specialist pharmaceutical product launch and commercial supply solutions including complex patient kit processing and complements Almac Pharma Services’ three European locations.

Harry Lindenmuth, VP Operations and Audubon Site Head, Almac Pharma Services, said: “This certification marks an important regulatory milestone for our facility in Audubon, PA. It represents further evidence of our continued commitment to offering best-in-class, quality-led and tailored services for our clients, and the patients they serve.

“This accomplishment is testament to the continued progress in developing the site by the Audubon team. Congratulations to everyone involved in making this possible. We look forward to the continued growth of Almac Pharma Services in the US.”

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Almac Group releases 2023 Corporate Social Responsibility Report

brendanhagan — Thu, 09 Nov 2023 10:07:54 +0000

Annual report highlights the Group’s progress and commitments to our people, our planet, and the communities in which we operate.

Almac Group today announces the release of the company’s 2023 Corporate Social Responsibility report, which highlights Almac’s progress and commitments to our people, our planet, and the communities in which we operate.

The report also provides insights into Almac’s client delivery across the drug development pipeline, and a look into the company’s ambitious growth strategy posed to sustain best-in-class service offerings to clients and bolster innovation.

Alan Armstrong, Chairman and CEO, commented: “Almac’s mission to advance human health is the driving force behind everything we do as an organisation. We are exceedingly proud of how we have delivered on our responsibilities this year—particularly, our progress towards our commitment to reach net zero by 2045, our further investment in health and wellbeing offerings for our people, and our contributions to our communities.

“We are also proud to recognise the essential role our colleagues have played in our success – by living out our mission each day, they are collectively impacting human health across the globe.”

In 2022, Almac announced a commitment to reach net zero by 2045, and to reduce Scope 1 and Scope 2 emissions by 50 percent by 2030. Highlights from this year’s report that support the company’s net zero ambition include:

Joining the Science Based Targets Initiative (SBTi), which defines and promotes best practice in science-based target setting for the reduction of greenhouse gases

Appointing a dedicated Global Energy Manager to drive actions to support Almac’s net zero commitment, and develop business improvement initiatives across the globe

Almac is also wholly committed to supporting, developing, and rewarding our people, as well as making a positive and lasting contribution to our communities. Highlights from the last year in these areas include:

2,000 employees received recognition awards

Reaching 100% of employees with health and wellbeing programme

Supporting 40 different charities through global philanthropy

Reaching an estimated 10,000 post-primary pupils through in-person and virtual outreach programmes.

Almac’s CSR strategy is designed to align priorities with the United Nations’ Sustainable Development Goals (SDGs) and the Pharmaceutical Supply Chain Initiative (PSCI).

Read the full report here – https://www.almacgroup.com/corporate-social-responsibility

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Almac Group releases details of £80 million expansion in Northern Ireland

brendanhagan — Thu, 19 Oct 2023 09:00:00 +0000

Expansion will create 550 jobs in 140,000ft² development and manufacturing facilities

The Almac Group has today announced details of an £80 million investment programme to build new extensive manufacturing, production and diagnostic laboratory facilities at its Global Headquarters in Craigavon, Northern Ireland.

The construction of these two significant facilities will create over 550 jobs locally, spanning a range of lab and non-lab-based roles, with recruitment already commenced for some positions. This is part of the company’s international recruitment drive which is expected to create 1,000 jobs in Northern Ireland over three years.

The expansion, which is part of the global investment programme announced in 2022, will significantly grow operations for two of the Group’s business units, Almac Pharma Services and Almac Diagnostic Services.

Almac Pharma Services supports the development and commercialisation of new treatment options for a wide range of therapy areas including oncology and immunology. Almac Diagnostic Services offers a range of biomarker discovery, development and commercialisation solutions to Biopharma partners globally.

The first of these two major projects is a 100,000ft² state-of-the-art multi-product Good Manufacturing Practice (GMP) facility for Almac Pharma Services. This Centre of Excellence for manufacturing will house a custom designed dispensary area, multiple production suites, process equipment wash facilities and a lineside warehouse for ambient, refrigerated and frozen storage. The new facility will primarily support solid oral dose products, complementing Almac’s existing capabilities in this area.

The facility, which will be operational from Q3 2024, will expand Almac Pharma Services’ existing manufacturing capabilities and offers additional capacity for further strategic production contracts. The high-specification production suites have been designed with flexibility and a wide range of uses in mind which offers opportunities for clients to install bespoke technology specific to their individual needs.

The second project is a 40,000 ft² four-storey diagnostic development and manufacturing centre for Almac Diagnostic Services which will be completed by Q1 2024. The new facility will enable Almac Diagnostic Services to expand its assay development offering and to manufacture and distribute Companion Diagnostic (CDx) kits on a commercial scale to support growing client demand.

This expansion will enhance Almac’s existing early phase biomarker development capabilities through to assay development and deployment in clinical trials, cementing the company’s position in the market as a fully resourced partner of choice to pharma companies for manufacturing and commercialisation of companion diagnostics.

Alan Armstrong, Chief Executive of Almac Group said: “Almac is committed to re-investing all our profit back into the business.

“This £80 million expansion and the creation of 550 new, highly skilled jobs in Northern Ireland will ensure that we remain the global leaders in our industry, giving our clients and ultimately patients across the world who benefit from these therapeutics, the best possible offering from Almac.”

These projects have been supported by Invest Northern Ireland who have welcomed the development and ongoing expansion of the Almac Group.

Jeremy Fitch, Executive Director of Business Growth Group, Invest Northern Ireland said: “Almac’s commitment to innovation and excellence has positioned it as a cornerstone of our region’s Life & Health Sciences success story and supported it to build a world-renowned reputation for ground-breaking work in the global pharmaceutical industry.

“We are delighted to support this investment which is creating hundreds of employment opportunities in the Armagh, Banbridge and Craigavon Borough Council area and will bolster Northern Ireland’s reputation as a hub for pharma and diagnostic development. We commend Almac’s dedication and vision and we look forward to witnessing the positive impact this investment will have on Northern Ireland’s economy and the advancement of life changing medicines.”

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Almac Sciences and HydRegen successfully complete first scale up of their joint development project

brendanhagan — Wed, 11 Oct 2023 08:00:00 +0000

Joint project to develop sustainable chemical processes funded by UK Innovation & Science Seed Fund (UKI2S) and Innovate UK (IUK)

Almac Sciences, a member of the Almac Group, in partnership with HydRegen, has completed the first scale up demonstration of the joint Almac Sciences – HydRegen bio-manufacturing route to a critical commodity chemical, achieving >99.9% conversion in industrially relevant timeframes in a kilo-lab hydrogenation facility.

The demonstration combines Almac Sciences’ Carbonyl Reductase (CRED) enzyme with HydRegen’s proprietary enzyme platform with a ‘lead’ for clean and efficient carbonyl-to-alcohol conversion. This demonstration takes the HydRegen platform for enabling biocatalytic hydrogenation closer to large-scale manufacturing and showcases its capabilities for supporting a more energy, cost and resource efficient chemicals sector.

The project, funded by UK Innovation & Science Seed Fund (UKI2S) and Innovate UK (IUK) alongside private investors, was launched 18 months ago to develop and scale up the HydRegen technology for more sustainable commodity chemical manufacturing and subsequent implementation into new chemical processes.

Prof. Tom Moody, VP Technology Development and Commercialisation at Almac Sciences said: “I am very pleased to see the high conversion achieved by the team using the HydRegen technology coupled with the Almac CRED enzyme. I look forward to running this process under flow conditions and showcasing the benefits of running this bioreduction.”

Click here for more detailed information on the joint project.

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Almac selected as finalist for KTP “Best of the Best” awards

amoreland — Fri, 01 Sep 2023 13:08:41 +0000

The only Northern Irish company to reach the finalist category of awards to celebrate the most positive impacts of Knowledge Transfer Partnerships

Almac Sciences, a member of the Almac Group, has been shortlisted as a finalist in the Technical Excellence category at this year’s national Knowledge Transfer Partnership (KTP) Awards by Innovate UK.

The award nomination was based on the successful completion of a three-year research project in collaboration with Queen’s University Belfast (QUB) and is the only Northern Irish submission to be shortlisted.

The project involved the development of highly innovative continuous flow processes with a key focus on high pressure hydrogenations to access critical raw materials for the chemical industry. This project was recently awarded the highest grade of “outstanding” by the grading panel after successfully meeting all the KTP’s objectives and is only one of three finalists in this prestigious category.

The Innovate UK-funded KTP aimed to embed flow technologies to ensure long term security of supply for critical raw materials through development of a continuous flow technology. Continuous flow chemical manufacture is impacting the drive to strengthen supply chain resilience, contribute to Net Zero Impact and support continued growth of the chemical manufacturing sector here in the UK.

Gary Morrison, former KTP associate is now a Chemist in the Custom and Flow team at Almac commented: “It is an honour to be shortlisted as a finalist in the Technical Excellence category at this year’s national KTP awards by Innovate UK. Contributing to the evolution of flow chemistry expertise at Almac throughout the 3-year project has been hugely beneficial and I am delighted that we have been recognised. I would also like to thank my academic and industrial mentors Dr. Haresh Manyar and Dr Megan Smyth for their expertise and advice.”

Dr. Scott Wharry, Custom and Flow Chemistry Manager, Almac Sciences added: “We once again offer our congratulations to the whole team on this recognition. The KTP project has been a huge success which has embedded new technology, capacity and knowledge into Almac. As an organisation we understand the criticality of creating academic partnerships via programs such as KTP to help drive innovation whilst developing the necessary skills to secure a pipeline of talent within the pharmaceutical industry.”

The KTP awards ceremony will be held on Wednesday 18th October in Cardiff.

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Almac expands Next Generation Sequencing capabilities through investment in new Illumina NovaSeq™ X Plus instrument

amoreland — Thu, 31 Aug 2023 08:00:00 +0000

Almac Diagnostic Services, a member of the Almac Group, has announced investment to expand its Next Generation Sequencing (NGS) capabilities for BioPharma partners, following the purchase and installation of the first Illumina NovaSeq™ X Plus instrument in Northern Ireland and the whole island of Ireland.

This investment in the newest and most powerful instrument from Illumina enhances Almac’s NGS portfolio of DNA Sequencing Service offerings, including Whole Genome Sequencing, Whole Exome Sequencing and a range of RNA Sequencing Service offerings for Biomarker Discovery projects.

Adding the Illumina NovaSeq X Plus’s powerful processing capabilities to Almac’s existing range of NGS platform offerings will enable even larger sample runs, greater read depth, including both short and long-read sequencing and faster speeds. As a result, it will increase throughput, variant detection quality and accuracy, while reducing turnaround time and cost per sample for client biomarker research projects.

Michael Sloan, Global VP of Commercial Operations, Almac Diagnostic Services said: “Almac is at the cutting edge of NGS diagnostics. Investing in this new instrument further enhances our DNA and RNA panel offerings, opens the potential for further expansion of our NGS solutions for clients and significantly increases overall sequencing capacity, ensuring that Almac continues to play a leading role within precision medicine.”

Almac Group has committed to achieving net zero by 2045 and to reducing Scope one and Scope two emissions by 50 percent by 2030. Illumina’s focus on sequencing sustainability to reduce impact on the environment aligns with this commitment. The NovaSeq™ X Plus has 90 per cent less packaging weight and waste, new compact cartridges and packaging design and more recyclable plastics which helps to save on disposal costs and environmental impact.

“Almac has a record for excellence in precision medicine and we are delighted that as an important strategic partner, it’s taken delivery of the first NovaSeq™ X Plus instrument in Northern Ireland and Ireland and invested in this state-of-the-art technology to significantly expand its high-throughput sequencing capabilities,” said Mark Robinson, General Manager, UK and Ireland, Illumina. “With its new chemistry, the NovaSeq X series will enable, Almac, to maximise productivity and minimise turnaround time, with faster, more powerful, and more sustainable sequencing.”

Find out more about Almac’s range of Genomic Services.

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Almac Group grows by 150, exceeding 500 total headcount in Durham

amoreland — Wed, 30 Aug 2023 13:00:00 +0000

Corporate investment and client demand leads to growth in headcount by more than a third in two years.

Almac Group, the global contract development and manufacturing organisation, today celebrates that the company has exceeded 500 employees at its Durham, North Carolina location. This organic growth has led to 150 new employees joining the company since 2021, an over 30% increase in total headcount for the site.

Almac’s rapid growth in Durham is solely as result of inward investment and increased client demand for the company’s market – leading clinical and diagnostic services offered at the site. Since taking occupancy at the technology park in 2000, Almac has more than doubled capacity, now spanning four buildings on the campus totaling 150,000 ft2.

Almac is a privately owned, Northern Ireland – based company that re-invests all profits back into its business. The company has continued to demonstrate a commitment to the growth and stability of its North Carolina operations by launching a number of specialist capabilities for the Group at the site since its inception. These investments over the years have included significant capacity expansions for clinical supply services, the opening of diagnostic laboratory, the launch of an innovative temperature monitoring system for clinical supplies, and the addition of ultra-cold and Cryogenic clinical services capabilities to meet the demands of Advanced Therapeutic Medicinal Products (ATMPs).

As a further part of Almac’s commitment to the community, the past two years in Durham have also included ongoing and extended charitable partnerships with North Carolina A&T State University, Duke Children’s Hospital, No Kid Hungry NC, and the Triangle Community Foundation, among many others.

“We are thrilled to celebrate this corporate milestone in Durham, exceeding 500 employees,” said Donna Christopher, Global Vice President of Operations and lead of the Durham facility. “At Almac, we believe our people are our greatest asset— and it’s a testament to our meaningful work and culture that we have successfully retained and grown even among challenging times.”

“Our region here in Durham has exceptional talent, community partners and opportunities – and Almac is thrilled to continue our growth and commitment in this community. We look forward to the impact our work here will continue to have on our clients and patients globally,” she continued.

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Almac Group marks groundbreaking of $65 million facility expansion in Montgomery County

brendanhagan — Mon, 07 Aug 2023 08:00:00 +0000

Capital growth project expands Souderton campus by nearly 50% of current footprint and brings 355 local jobs to the region.

Almac Group, the global contract development and manufacturing organisation, today marks the ceremonial ground breaking of a $65 million expansion project on the company’s North American headquarters campus in Souderton, PA.

This expansion is a strategic investment in Cold Chain Operations, Just-In-Time Processing, and Analytical Testing capabilities. These are crucial to supporting the development of Advanced Therapeutic Medicinal Products (ATMPs). As previously announced in August 2022, the expansion will yield a 60% increase in capacity for Almac’s clients, supported with a projected total of 355 new jobs by 2026.

The project will bring 115,000ft²of new building space to the campus, adding an additional 50% of the current footprint upon its completion in 2025. In keeping with Almac’s commitment to reach net-zero emissions by 2045, construction plans will follow U.S. Green Building Council LEED certification standards for healthy, efficient, carbon and cost-saving green buildings.

Further environmental safeguards include the installation of a 140-foot pedestrian bridge to minimise impact to the environment on the expanded campus, while also enhancing walkability for employees and guests.

This news follows Almac’s recent announcement of record breaking financial results and confirmation that its global workforce has reached 7,000.

Alan Armstrong, Almac Group Chairman and CEO remarked at the ground breaking ceremony:

“Today’s ceremony is a welcome sign of the continuation of growth for the Almac Group. I would like to thank all within the organisation for playing their part in our success. We are committed to reinvesting all our profits back into the business, and this expansion in Pennsylvania will play a vital part in our continued growth.”

“Almac is dedicated to ensuring we remain a global leader in our industry, giving our clients, and ultimately patients, across the world the best possible offering. We continue to play our part as a valued and trusted member of the communities in which we operate.”

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Almac Group opens a new custom-built GMP warehouse at its Global Headquarters

amoreland — Wed, 19 Jul 2023 13:00:00 +0000

The new custom-built facility will consolidate the existing warehouses to support all manufacturing and laboratory activities.

Almac Sciences, a member of the Almac Group, has officially opened a new custom-built GMP warehouse and dispatch hub at its Global Headquarters in Craigavon, UK.

The new 19,500 square foot facility consolidates the existing warehouses and supply chain offices and will provide support to all Active Pharmaceutical Ingredient (API) manufacturing and laboratory activities, from development to commercialisation.

The warehouse has capacity to store 500 pallets of solvent, 800 pallets of 15-25^oC materials as well as walk-in fridge and freezer- all of which are connected to an Environmental Monitoring System (EMS). The facility also houses downflow booths for sampling incoming materials and is the centralised location for all staff in the Supply Chain department. An extensive expansion area also remains for additional office space on the first floor.

This new building forms part of the multi-million-pound manufacturing investment programme to support client requirements. The first stage of Almac’s GMP facility expansion was announced in December 2022 with an extension to its current GMP manufacturing facility. The next stage will create manufacturing centres of excellence to support small molecule API production at up to 200 – 300kg scale, as well as increased capacity for peptide API production.

Michael Rainey, Head of Supply Chain, Almac Sciences said: “The new warehouse has been designed to ensure there is sufficient capacity to support our manufacturing expansions in line with the GMP storage of raw materials and manufactured API. The consolidation of the Warehouse areas and Supply Chain offices provides a new central location for the warehousing, purchasing, imports and dispatch teams to provide support to the business’ ongoing growth plans.”

Dr Dan Bayston, Vice President, Small Molecule API, said: “Almac Sciences is undergoing a period of rapid growth and expansion within its manufacturing areas and our new warehousing and dispatch facility is critical to support the increased demand from our clients. This new facility at our global headquarters expands storage capacity by ~300% which aligns with our future growth plans within manufacturing, allowing us to better serve our clients, and ultimately patients, worldwide, thus enabling us to enhance human health.”

The next phase of development is currently underway with further manufacturing expansions which will be announced in due course.

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Almac Group Wins Life Sciences Team of the Year

amoreland — Fri, 07 Jul 2023 08:00:00 +0000

Almac Sciences, a member of the Almac Group, is delighted to announce a win in the Life Sciences Team of the Year category during this year’s Irish Life Sciences Awards ceremony, held on 6 July 2023 at Crowne Plaza Hotel, Dublin.

Almac Sciences’ Technology Group was selected as the winner of the “Life Sciences Team of the Year” category. The Technology Group is a multi-disciplinary team, offering a toolbox of innovative technology solutions for synthetic chemistry including biocatalysis, biology services, custom and flow chemistry, radiochemistry and physical sciences right through to manufacture on tonne scale.

Key to the success of the team is the integration of multi-disciplinary scientific expertise with the aim of developing new greener and sustainable chemical processes that go beyond the traditional realms of chemical synthesis. The team has delivered multiple innovative manufacturing processes for their clients and has enhanced Ireland’s position as a global chemical manufacture for the pharmaceutical and fine chemical sectors.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company, commented: “Receiving this award demonstrates our excellence in the research, development and manufacturing of high-quality chemicals which will ultimately be used in high-profile consumer and healthcare products across the globe.

“We are delighted that the Pharma Industry Awards have recognised our team for offering innovative technology and our contribution to chemical manufacture in a more sustainable way. We look forward to further contributing to the Island of Ireland’s growing role as a global hub of exceptional science, sophisticated technology and unparalleled expertise in chemical manufacture.”

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Almac Group signs up to Science Based Targets initiative

amoreland — Tue, 04 Jul 2023 11:15:00 +0000

Latest announcement underscores company’s commitment to be net zero by 2045

Almac Group today announces joining the Science Based Targets Initiative (SBTi), which defines and promotes best practice in science-based target setting. This development is the latest step taken by the Group on its path to reach net zero emissions by 2045.

By signing up to SBTi, Almac will set greenhouse gas reduction targets against stringent SBTi criteria. Once targets are set, they will be submitted for validation and approval and published externally. The SBTi initiative is a collaboration between CDP, the United Nations Global Compact, the World Resources Institute (WRI), and the Worldwide Fund for Nature (WWF).

Joining SBTi follows a number of other recent measures taken by the Group to support their net zero goal. These include the expansion of accreditations with the International Standard Organisation (ISO), accepted as the gold standard in health, safety and environmental activity.

In the UK and EU Almac’s sites are now accredited to ISO 50001:2018, a key standard in energy management and conservation. The Group has also expanded its ISO 45001 and ISO 14001 accreditations to include its integrated health and safety and environmental management systems at its site in Singapore. These represent important milestones along the previously announced global strategy to expand these internationally recognised accreditations to all of Almac’s facilities.

All of these recent developments are key components of Almac’s environmental strategy.

“Developing science-based targets for the reduction of greenhouse gas emissions is a crucial next step and demonstrates the commitment to our environmental responsibilities at Almac,” said Niall Harkin, Executive Director, Almac Group. “At Almac, we see transparency and alignment to internationally recognised standards as essential in demonstrating our commitment to making a measurable and positive impact on our planet. Signing up to SBTi, coupled with our latest ISO certifications represent an essential part of Almac’s plan to reach net-zero by 2045 and we are proud to mark these milestones in our progress.”

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Almac Group reaches a global workforce of 7,000 as it marks most successful financial year ever

amoreland — Wed, 07 Jun 2023 11:15:00 +0000

Almac Group, the global contract pharmaceutical development and manufacturing organisation, has today announced its financial results for year ending 30 September 2022.

Today’s figures show the company recorded a £105 million (14.3%) rise in revenue from £735 million in 2021 to £840 million in 2022. Pre-tax profits were recorded at £97 million, up from £81 million (20% increase) for the same period the previous year.

This comes as Almac also reveals today that its global workforce has now reached 7,000 people, a total growth of over 1,000 employees in the last 18 months. This rise, aligned with the current capital investment programme, means Almac is well on its way to delivering on the significant expansion plans that were first announced in November 2021.

Alan Armstrong, Almac Group Chairman and CEO said: “Today’s announcement is a welcome continuation of growth for Almac Group, and I would like to thank all within the organisation for playing their part. We are committed to reinvesting all our profits in the business, this success will play a vital part in our continued growth, expansion, and increase in our employee numbers.

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WEE1 Inhibitor discovered by Almac Discovery advanced into two clinical studies addressing the treatment of advanced solid tumours

amoreland — Tue, 06 Jun 2023 12:00:00 +0000

Almac Discovery, the drug discovery biotech operating within the Almac Group of companies, has announced that the highly selective WEE1 inhibitor which it licensed to Debiopharm (Switzerland) and now known as Debio 0123, has been progressed into further clinical studies. The first patients have now received treatment in two separate clinical studies involving glioblastoma (GBM) and small cell lung cancer (SCLC).

In both studies, Debiopharm has combined Debio 0123 with standard of care therapy in patients with either GBM, one of the most aggressive and common lethal tumours of the central nervous system, or SCLC, a highly aggressive, hard-to-treat cancer with poor prognosis.

The Debio 0123 programme offers the potential to improve clinical outcomes and quality of life for patients suffering from GBM or SCLC. In cancer cells, DDR pathways are often upregulated due to genomic instability, providing potential resistance pathways to DNA-damaging therapies. Therefore, blocking kinases such as WEE1 which play essential roles in DNA repair is likely to increase the cancer’s vulnerability to SOC therapies. Preclinical results have shown that Debio 0123 successfully crosses the blood brain barrier and inhibits tumour growth.

Dr Stephen Barr, Managing Director and President, Almac Discovery said: “Since the discovery of our highly selective WEE1 inhibitor, we have looked forward to understanding its potential therapeutic benefit for cancer patients across the globe. We are delighted that it has progressed into further clinical development in these two cancer indication studies with high unmet medical need and look forward to seeing further progress from this ongoing clinical research.”

“The Debio 0123 program originates from a growing awareness of DDR inhibition in fighting life-threatening cancers. Optimizing efficacy, while preserving safety are key elements that Debiopharm is eager to assess throughout the clinical development of Debio 0123. With the fruition of these factors, Debio 0123 could become the first choice WEE1 inhibitor.” Angela Zubel, Chief Development Officer, Debiopharm.

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Almac Group joins Employers for Carers to further support working carers

amoreland — Thu, 25 May 2023 08:00:00 +0000

The Almac Group, which employs over 6,500 people across the world has joined Carers UK’s business forum Employers for Carers (EFC), to enhance the support they currently give to working carers.

Almac, which is headquartered in Craigavon, is the first indigenous Northern Ireland company to join EFC, which provides guidance on how employers can support carers within the workplace.

According to Employers for Carers, almost one in seven employees juggle work with caring for older, seriously ill or disabled loved ones. The charity also says that without the right support, as many as one in six carers will have to give up work or reduce their working hours to care.

Dr Sue Bill, Global Vice President of HR, Almac Group, said: “Being the best employer is extremely important to Almac. We strive to foster a working environment and culture that is safe, inspiring and inclusive, helping our people to thrive both in and out of work.

“Given the multi-generational nature of our workforce, we know that many of our employees are juggling their work with caring responsibilities and it’s important we enable colleagues to do their caring role alongside their work.

“Being a member of Employers for Carers allows us to understand the impact caring can have and gives us additional tools and advice to provide even better support to our valued employees whether they need it now or at some point in the future.”

Liam Duggan, Senior Policy and Engagement Officer, Carers Northern Ireland, said: “We are delighted to welcome Almac on board as a member of Employers for Carers. Our purpose is to ensure that employers like Almac have the support to retain and empower employees with caring responsibilities and we very much look forward to further collaboration in the future.”

Almac has developed a host of practices and wellbeing initiatives across the business that support, develop and reward employees at every stage of their career.

This carers initiative also includes the launch of a carers toolkit which has been designed by our #All4health team to help employees define what it means to be a carer and how to access available support. A dedicated carers network will be set up to encourage employees to share advice and guidance with others and to help develop the business’s understanding of what additional support they need.

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Almac Diagnostic Services updates claraᵀ report with significant new content for cancer research

amoreland — Wed, 17 May 2023 13:20:18 +0000

Almac Diagnostic Services, a member of the Almac Group, has announced significant updates to clara^T, its unique software-driven solution for gene expression data analysis, which gives cancer researchers access to the most comprehensive and robust biomarker discovery support available.

Almac’s clara^T, which has supported over 60 oncology studies to date for multiple Biopharma and Academic clients, classifies the most biologically relevant gene expression signatures into a comprehensive easy-to-interpret report that covers all 10 Hallmarks of Cancer.

The updates include 16 new gene expression signatures across the Hallmarks of Cancer, improved functionality with online data access and simplified reporting through an interactive dashboard. Clients receive a unique, interactive report that allows the easy visualisation of the key discriminating biologies within either a large cohort or an individual tumour sample.

Toshimitsu Uenaka, President EPAT (Epochal Precision Anti-Cancer Therapeutics), at Eisai Inc., whose translational team have used Almac clara^Tstated: “We really found the clara^T analysis of our studies to be very informative and a useful tool for our future drug discovery.”

Adding these new gene expression signatures ensures that clara^T remains current in the market with the most up to date content available. Almac clara^T offers a unique solution in the market for biomarker discovery from either RNASeq data generated from sample profiling within Almac labs or from gene expression data sets generated elsewhere that require further bioinformatics analysis.

Professor Richard Kennedy, Global VP and Medical Director, Almac Diagnostic Services said: “Being able to equip leading Biopharma and academic cancer researchers globally with a powerful gene expression analysis platform has supported the identification of exciting new data.

“Conventionally gene expression signatures are applied individually to classify patients into molecular subgroups. Signatures designed to identify the same biology are often developed independently using different bioinformatics algorithms and therefore may not classify identically. To address this, we developed the clara^T software solution which uses consensus between multiple published signatures, categorised into the Hallmarks of Cancer, to classify cancers in a more robust manner. Importantly, this standardised bioinformatics approach enables the analysis of datasets in a highly reproducible and cost-effective offering.

“Our proprietary clara^T report has demonstrated its ability to accelerate mRNA-based research, enabling deeper insights into translational cohorts which leads to better drug development and trial stratification, potentially contributing to better patient outcomes in the future.”

Almac Diagnostic Services is hosting a GenomeWeb Webinar on Tuesday 13^th June alongside leading cancer researchers from the University of Kansas, USA. The webinar will focus on how clara^T was utilised effectively within breast cancer studies.

The LIVE webinar will be held at 11am EDT / 4pm BST and interested parties can sign up here.

To find out more about Almac clara^T visit: www.almacgroup.com/diagnostics/claratreport

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Almac Pharma Services Hosts Recruitment Open Day in Loughborough

amoreland — Fri, 12 May 2023 13:18:27 +0000

Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services, is actively recruiting to fill 30 new analytical roles over the next year, over half of which are live right now, with more to follow based at its Charnwood Campus in Loughborough.

As part of this recruitment, Almac is hosting two open day sessions on Wednesday 24^th May where interested candidates can tour the Charnwood facilities and find out more about the company, available roles and the wide range of career opportunities available.

A number of Almac’s analytical staff will be on hand to talk about their experiences of working at the global organisation. There will also be one-to-one sessions with Almac’s hiring teams to discuss CVs, learn more about individual roles and potential fast-track to interview. Registration to attend is now open here.

The expert team at Almac’s Charnwood facility partners with global pharmaceutical and biotech companies to provide tailored drug development, manufacturing and analytical solutions for a range of therapy areas including oncology, infectious disease and respiratory.

Trevor Clarke, Vice President of Analytical Operations, Almac Pharma Services, said: “Almac is experiencing significant growth and filling these roles will bolster our ability to continue to support our many clients across the globe.

“We are looking for talented analytical staff at all levels who can apply their current skills, expertise and ideas. You will play an essential role in helping us to achieve our goal of advancing human health, meaning you will make a real difference to patients in need.

“A career at Almac provides you with an excellent opportunity to join an established, global company where we are committed to your career success.

“If you are looking for a new challenge in a growing, progressive company, we want to hear from you!”

Jane Hunt, Member of Parliament for Loughborough has welcomed news of additional new job opportunities locally with Almac. She commented: “I am delighted at Almac’s success to date and excited at their level of ambition for growth.

“It is great to see highly skilled job opportunities being made available and I wish the company well in this latest recruitment drive. I look forward to seeing the company further expand and wish them continued success.”

Almac’s Charnwood facility has been a true success story since its acquisition in 2015, growing from a core staff of 70 people, the company now employs over 250 individuals and continues to increase its capacity and capabilities to meet increasing client demand for its innovative drug development services.

For more information on roles and recruitment within Almac Pharma Services, visit here.

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Almac Group Hosts Recruitment Open Day in the North West as 20 new jobs are announced

brendanhagan — Thu, 11 May 2023 13:14:33 +0000

The Almac Group is actively recruiting to fill another 20 new roles, including project management, software development and quality, based at their office on the Northland Road in the North West.

Almac is hosting two information sessions at 4pm and 6pm in the Everglades Hotel on Wednesday 24^th May 2023 where interested candidates can find out more about the company and the available roles.

Some of Almac’s employees will be on hand to talk about their experiences of working at Almac. There will also be one-to-one sessions with Almac’s hiring teams to discuss CVs, hear more about individual roles and potential fast-track to interview. Registration to attend is now open.

Almac opened their facility in Derry/Londonderry in December 2021 and plans to continue developing their operations here over the next few years.

Alan Armstrong, CEO, Almac Group, said: “We are looking for talented people from a range of different backgrounds who can apply their current skills and ideas to our industry.

“A career at Almac provides you with an excellent opportunity to join an established, global company where we are committed to your career success.  You will play an essential role in helping us to achieve our goal of advancing human health, meaning you will make a real difference.

“Almac is experiencing significant growth and filling these roles will bolster our ability to continue to support our many clients across the globe. We are proud to have our global Headquarters in Craigavon and we are very pleased that we have an established and growing base in Derry/Londonderry.

“If you are looking for a new challenge in a growing, progressive company, we want to hear from you!”

The Mayor of Derry City and Strabane District Council, Councillor Sandra Duffy has welcomed news of additional new job opportunities locally with Almac. Encouraging applicants to avail of the opportunity to work with a global company of such a high calibre, Mayor Duffy said the council was delighted to be working alongside Almac in its recruitment drive and was supportive of its efforts to expand its workforce to employ the pool of educated and skilled people in the city and district.

Mayor Sandra Duffy said: “I am delighted at Almac’s success to date and excited at their level of ambition for growth for the future. The Council is committed to working with local companies to drive employment and create exciting new opportunities for job seekers. It is great to see highly skilled job opportunities being made available and I wish the company well in this latest recruitment drive. I look forward to seeing the company further expand and wish them continued success in our city and district.”

Almac is a global contract development and manufacturing organisation with over 6,500 employees located in 18 locations across the world, almost 4,000 of whom are based at the global Headquarter campus in Craigavon.

To find out more or to apply for a position, visit www.almacgroup.com/northwest-jobs

Experience of the pharmaceutical industry is not an essential requirement for these roles as full on-the-job training is provided.

ENDS

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Almac Sciences and University College Dublin BROADEN Continuous Flow Chemistry Collaboration

amoreland — Thu, 04 May 2023 13:10:01 +0000

Almac Sciences, a member of the Almac Group, announces a strengthened collaboration with University College Dublin (UCD) that will focus on the development of novel continuous flow protocols for accessing new industrially relevant drug targets.

The new project, entitled “BROADEN”, involves continuous flow in-situ Bromination for Application in the synthesis of Drugs and thEir buildiNg blocks. These are among the most fundamental transformations in organic chemistry, allowing the functionalisation of simple substrate molecules to become advanced building blocks for today’s drugs.

Successful completion of BROADEN will result in a competitive edge for chemical manufacturing in Ireland including societal impacts through improved access to cheaper chemicals and medicines, economic impacts (lowering cost of goods, shorter processes, less waste) and improved sustainability metrics.

This is a four-year project, co-funded by Almac Sciences and the Irish Research Council, through their enterprise partnership scheme. It will develop methods that generate bromine from benign precursors and through continuous flow approaches, immediately consume the reactive intermediate in a variety of industrially relevant chemical transformations. The project expands the existing collaboration with Dr Marcus Baumann at UCD where a range of projects utilising continuous flow for both oxidations and enzyme mediated transformations are ongoing.

Davin Cronly, PhD student at UCD, said: “This research is exciting as there is the potential to develop innovative solutions to complex scientific challenges. I want to use my knowledge as a chemist to make a real impact on the lives of those around me and I am looking forward to spending time at Almac Sciences to learn from industrial experts.”

Dr Megan Smyth, Team Leader and UKRI Future Leaders Fellow, Almac Sciences commented: “We are delighted to welcome Davin to the collaborative team we have established between Almac Sciences and UCD. I look forward to mentoring and working closely with Davin in the development of novel continuous flow protocols, applying/disseminating these outputs into industrial best-practice and wish him every success in his studies.”

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Almac Announces Launch of IXRS®3 Partnership Network

amoreland — Tue, 25 Apr 2023 13:06:00 +0000

Almac Clinical Technologies, a member of the Almac Group, has announced the launch of its IXRS®3 Partnership Network for biopharmaceutical sponsors, which aims to accelerate the development and delivery of innovative eClinical solutions.

Almac Clinical Technologies has over 25 years’ experience of working in partnership with specialist technology and service companies and understands that the interoperability of eClinical data systems is a priority for biopharmaceutical sponsors.

This Partnership Network gives sponsors and CROs the opportunity to share data and solutions to build a more inclusive clinical trial experience for all sites and patients.

George Tiger, Global Vice President of Almac Clinical Technologies Global Business Development, said: “Managing a mix of technologies throughout the course of a clinical trial is a common pain point for sponsors and service providers. Clinical technology companies who can demonstrate flexibility and interoperability can make the study build process and support more seamless, more transparent, and more cost-effective for sponsors and sites.

“IXRS®3 is the most trusted Interactive Response Technology platform in the industry¹ and our aim is to build the most in-depth and innovative partnership network in the eClinical space.

“We are thrilled that some of the most innovative names in the industry have already joined the Partnership Network including Veeva, THREAD, Kayentis, N-SIDE, and ESMS Global. Their expertise spans clinical development cloud software, eCOA, decentralised clinical trials, clinical supply planning and optimisation, and medical monitoring.”

Mike Hutton, the Head of Partnerships and Strategic Alliances at ACT concluded: “We share an important goal with our trusted partners to provide our sponsors, sites, and patients with the best eClinical technology and services in the industry, and we can do it much better together.

“We look forward to growing this network with more partners as we strive to improve interoperability, making clinical trials easier to conduct for our sites and sponsors and participation easier for patients.“ For more information and to join the IXRS®3 Partnership Network, click here.

ENDS

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Almac Appoints Global Energy Manager as part of ongoing commitment to net zero strategy

amoreland — Fri, 21 Apr 2023 13:03:00 +0000

The Almac Group has announced the appointment of Ramees Raja as Global Energy Manager.

This is a new role which will drive actions to support Almac’s commitment to be net zero by 2045 and to reduce the Group’s Scope one and Scope two emissions by 50 percent, by 2030.

Ramees will work closely with Almac Group’s Corporate Social Responsibility and Procurement teams to develop business improvement initiatives across the globe. These initiatives will include the use of solar panels across various Almac buildings, participation in power purchase agreements, moving away from the use of natural gas and the continued roll-out of our energy management standard ISO5001 across all operational Almac sites.

Ramees has more than 12 years’ experience working with a range of organisations, including Ameeri Industries and Iqonomic. He joins Almac from Muntons where he was Group Energy Manager, responsible for group’s Energy management and Renewable Energy Projects.

Ramees holds a BEng in Electrical and Electronic Engineering and MSc in Renewable Energy Engineering.

Niall Harkin, Almac Group Executive Director said: “It gives me great pleasure to announce Ramees’ appointment as Global Energy Manager. His wealth of expertise and experience will be instrumental in progressing our sustainability commitments.”

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Almac Group Enters Strategic Partnership with North Carolina A&T University’s Deese College of Business & Economics

admin — Thu, 30 Mar 2023 12:58:00 +0000

Partnership aims to build talent pipeline between the global organisation and the top-ranked, North Carolina-based public HBCU.

Almac Group is pleased to announce a new strategic partnership with the Willie A. Deese College of Business and Economics at North Carolina Agricultural and Technical State University.

The partnership will build a talent pipeline between the global organisation and the university, the nation’s largest and top-ranked public historically Black college and universities (HBCU). The partnership serves as a springboard for unique student engagement, recruitment, and mentorship opportunities with Almac Group.

Engagement launched this month with a “Day in the Life” visit for students in the Deese Aggie Supply Chain Club at Almac’s Durham, North Carolina facility, including a meet and greet for students and Almac’s global supply chain leadership, a facility tour and a panel discussion on topics ranging from global supply chain opportunities to industry career advice.

This partnership marks Almac’s latest commitment to inspire the next generation’s students in the communities local to the global organization’s 18 facilities across the world, a key corporate social responsibility and recruitment initiative of the Group.

“Almac Group is committed to investing in the future we wish to see in our communities, and understand that contributing to a strong and diverse local workforce is paramount not only for the success of Almac, but for the prosperity of our community,” said Donna Christopher, Global Vice President of Operations at Almac Clinical Services. “We are very fortunate to have an esteemed institution like North Carolina A&T right in our backyard, and we look forward to influencing future industry business leaders together.”

North Carolina A&T’s Deese College is the top-ranked undergraduate and graduate business program at a public HBCU according to U.S. News and World Reportrankings, and is a comprehensive business school with approximately 1,800 students, 87% of whom are black and 95% of whom are from underrepresented populations. The Wall Street Journal ranked A&T as the No. 2 university in America for combining research and classroom teaching.

“Almac’s commitment will provide invaluable support by preparing our students for the needs of today’s workforce,” said Dr. Lisa Owens-Jackson, interim dean of the Deese College. “Our programs strive to provide career readiness, innovative academic experiences, and experiential learning to enable and produce highly qualified students with strong business skills. Partnerships with global leaders like Almac Group open doors and enrich our students’ experience.”

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Technical Quality Team Leaders Graduate with Masters in Pharmaceutical Validation Technology

admin — Fri, 24 Mar 2023 13:52:00 +0000

Three members from Almac Group’s Pharma Services’ Technical Quality team, Emma Kelly, Jason Wilson and Darryl McConnell recently graduated from Technological University Dublin with a Masters of Science in Pharmaceutical Validation Technology.

The graduates began the intensive course in January 2020 and completed it earlier this year. It has expanded their advanced technical knowledge and in turn benefitted the teams they lead.

The Technical Quality team has been focused on developing employee knowledge through a range of qualifications and CPD modules with the ultimate goal of enhancing client delivery. This has been endorsed by the Executive and Senior Management teams, particularly Trevor Clarke, VP Analytical Operations.

Trevor Clarke said: “Almac Pharma Services is committed to investing in the continual training and upskilling of our employees. Providing support from placement students through to Master’s degrees ensures that we continue to carve a pathway to develop and grow knowledge in a productive and beneficial way.

Courses in validation are not widely available which makes these MSc credentials an important asset to the knowledge we provide to our clients. We previously shared the news that a number of the Technical Quality team had completed CPD modules in validation. The successful completion of this course helps to build on the knowledge and experience that has already been developed.

Throughout the MSc, Emma, Darryl, and Jason, who are all line managers were supported to focus on their studies during semesters. They all demonstrated immense dedication to complete the remainder of their course workload during evenings and weekends, largely during the pandemic.

The knowledge gained by everyone is evident at cross-functional internal business meetings, client and vendor calls, audit support and in the direction given to their respective teams on validation strategy, execution, and overall compliance.

Knowledge sharing is key and each of the team leaders regularly share materials and learnings with their teams and support employees who are undertaking CPD Modules from the same course.

Congratulations to Emma, Darryl, and Jason on their significant achievement.”

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Almac Sciences successfully completes an outstanding Knowledge Transfer Partnership with QUB

amoreland — Wed, 15 Mar 2023 16:00:00 +0000

Almac Sciences has been awarded the highest grade of “outstanding” by the KTP Grading Panel.

Almac Sciences, a member of the Almac Group, has been awarded the highest grade of “outstanding” by the Knowledge Transfer Partnership (KTP) grading panel following the successful completion of a three year project in collaboration with Queen’s University Belfast (QUB).

The project which looked at the development of highly innovative continuous flow processes with a key focus on high pressure hydrogenations received the highest accolade after successfully meeting all of the KTP’s objectives.

The Innovate UK-funded KTP aimed to embed flow technologies to ensure long term security of supply for key raw materials through development of a continuous flow platform technology. Continuous flow approaches are impacting the drive to ensure novel, improved technologies strengthen supply chain resilience, contribute to Net Zero Impact and support continued growth of the manufacturing sector.

Dr. Megan Smyth, Team Leader and UKRI Future Leaders Fellow, Almac Sciences commented: “The KTP project has been a huge success which has embedded new technology capacity and knowledge into Almac. As a CDMO, having a wide range of synthetic capabilities is essential to deliver on the complex target chemical structures that our customers contract us to manufacture.”

The main achievements from this KTP partnership include the build and installation of flow rigs within Almac Sciences and the successful delivery of multiple projects at 100’s of kgs scale. Project success has been disseminated through peer reviewed publications, multiple conference presentations, poster prizes and retention of the KTP associate in a full-time employment within the company.

Dr. Scott Wharry, Custom and Flow Chemistry Manager, Almac Sciences, commented: “Congratulations to the whole team on the successful completion of the KTP. Receiving the highest accolade is testament to the hard work throughout the project. The flexibility and resilience demonstrated by both the KTP associate, Academic supervisor and Company supervisors during the pandemic was admirable as they worked tirelessly to ensure project delivery and managed change to deliver with a business-centric focus.”

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Almac Group Awarded with Six CDMO Leadership Awards Across all Core Categories

amoreland — Tue, 21 Feb 2023 12:00:00 +0000

Overall recognition received for compatibility, expertise, quality and reliability.

Craigavon, N.I. – Almac Group, the global contract development and manufacturing organisation, is delighted to announce it has won six CDMO Leadership Awards for 2023.

The CDMO Leadership Awards recognise top performing CDMOs, celebrating outstanding companies in drug development and manufacturing, emphasising high standards of quality, integrity and innovation exemplified in their work. The winners will be presented with an award at a ceremony on 22nd March in New York.

Primary market research by Industry Standard Research (ISR) is the basis of the awards. 72 contract manufacturers were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. This experiential feedback was analysed by sponsor company size to reveal leading CDMOs in different performance categories. CDMOs must meet the minimum threshold of customer survey responses to be eligible for an award.

Almac was successful in achieving awards in all core categories including:

Excellence in Capabilities (Small Pharma)
Compatibility (Overall and Small Pharma)
Expertise (Overall and Small Pharma)
Quality (Overall and Small Pharma)
Reliability (Overall and Small Pharma)
Service (Small Pharma)

Winners in each of these categories were judged by their customers as either exceeding expectations or as top performers in outsourced projects conducted within the past 18 months.

Outside of the core metrics, Almac also received individual attribute awards for five additional categories – accessible senior management, innovation, on-time delivery, reputation and right first time.

John McQuaid, President and Managing Director, Almac Pharma Services, commented: “I am both delighted and proud that Almac has been recognised again by Life Science Leader at the annual CDMO awards. To have won in all six categories, and four overall reflects the commitment of the Almac team who work hard to provide best-in-class, tailored solutions to our global client base and their patients. The accreditations are particularly meaningful as we have been evaluated by customers we have partnered with.”

Stephen Barr, President and Managing Director, Almac Sciences, added: “To receive this recognition, influenced directly from our clients, is a fantastic endorsement and testament to our excellence in research, development and manufacturing of high-quality chemical products used in high-profile consumer industries across the globe. We are delighted that Life Science Leader has recognised our team for delivering innovative, original, and high-quality service and solutions in these categories which has contributed significantly to the betterment of human health.”

Kate Hammeke, Vice President, Industry Standard Research said “Industry Standard Research is proud to be a part of the CDMO Leadership Awards. ISR’s research methodology ensures that the people who participate in the contract manufacturing benchmarking market research are highly qualified decision-makers with first-hand experience working with the suppliers they evaluate. These awards are based on experiential feedback and enable users of ISR’s market research to make data-driven decisions with respect to choosing an outsourcing partner. It also means the winners of these awards have been delivering the highest quality of service according to their current and recent customers and are deserving of these accolades for their distinction.”

To learn more about Almac’s exceptional culture and commitment to quality, please visit our website: https://www.almacgroup.com

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Almac Pharma Services and Provention Bio, Inc Celebrate Rapid Launch of TZIELD™ (teplizumab-mzwv)

amoreland — Tue, 14 Feb 2023 13:00:00 +0000

Audubon, PA, USA – 8 February 2023 – Almac Pharma Services was delighted to welcome the Provention Bio Inc’s management team to celebrate the successful packaging and rapid launch of Provention Bio Inc’s first biologic treatment, TZIELD™ (teplizumab-mzwv) into the US market.

TZIELD* was approved on November 17 by the U.S. Food and Drug Administration for intravenous use as the first and only immunomodulatory treatment to delay the onset of Stage 3 Type I diabetes (T1D) in adult and pediatric patients aged 8 years and older with stage 2 T1D. Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening.

The Provention Bio Inc’s team toured the Almac Pharma Services’ Audubon, PA facility and met with some of the team who have been key to ensuring their product had a smooth and successful launch. Culminating in a celebratory lunch and presentation to the operational staff, sharing insights into the patient journeys that have been key in the development and delivery of TZIELD™. The visit was proposed by Provention Bio Inc as an opportunity to recognise and thank the operational teams who work so hard on packaging and preparing their drug product for market.

The Almac Pharma Services’ Pennsylvanian based team began its partnership with Provention Bio, Inc. to support the packaging of the TZIELD product for commercial supply in 2020. Together they agreed on an appropriate strategic programme to efficiently, and effectively, prepare the specialised treatment for distribution including expediting all aspects of packaging and labelling to distribute TZIELD to patients within weeks of FDA approval. This visit further solidifies the by Almac Pharma Services and Provention Bio Inc, to advance the treatment of T1D to patients.

Harry Lindenmuth, VP Operations Audubon, Almac Pharma Services commented: “We are pleased to have Provention Bio, Inc join our teams on site to celebrate the successful launch of their first biologic treatment. Almac Pharma Services is delighted to have played a role in packaging this key advancement. Being able to mark this occasion with Christina and the Provention Bio Inc management team has been very meaningful to our own team. Seeing the patient journeys has been particularly impactful.”

Almac Pharma Service’s commitment to partnering to advance human health is most visible through key partnerships with companies such as Provention Bio, Inc., who are working to advance life-changing treatments and therapies to patients.

*TZIELD may cause serious side effects, including Cytokine Release Syndrome and a decrease in white blood cells. Please see Important Safety Information http://bit.ly/3VgvSjX and Medication Guide and Prescribing Information http://bit.ly/3hZZiEK.

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Almac Group Opens Registration for Internationally Recognised Process Chemistry Forum in Belfast

amoreland — Thu, 26 Jan 2023 12:00:00 +0000

Registration is now open for the Nordic-Irish Process Chemistry Conference, June 2023

Almac Sciences, a member of the Almac Group, is delighted to announce that registration is now open for the Nordic-Irish Process Chemistry Forum, taking place from 6 – 8 June 2023. This internationally recognised forum for leaders in process chemistry, will be held in Belfast, Northern Ireland for the very first time in the event’s history.

As a leader in process chemistry and R&D, Almac Sciences will host the forum, which has a long history of attracting some of the most respected and innovative speakers in the world of chemistry. The Belfast event will be the 9th forum since it was founded in 2004.

The main driver of the forum has always been to bring together scientists who are involved in the design and scale up of chemical processes. This upcoming event in Belfast is no exception — an impressive line-up of industrial and academic speakers has been secured for the forum including Professor Oliver Kappe, Professor Anthony Burke and Professor Andreas Liese, covering a range of subjects within the process chemistry field.

Professor Tom Moody, VP Technology Development & Commercialisation at Almac & Arran Chemical Company commented: “We are excited to share our agenda and formally open this event for registration. Participants will truly benefit from learning about the rich chemistry expertise and innovative research taking place among industry and academia across the EU and within the island of Ireland. For the first time we are also giving PhD students the opportunity to showcase their research studies in front of industry peers. There will be no better audience to engage with and I strongly urge early registration.”

The Nordic Irish Process Chemistry Forum will be held from 6 – 8 June 2023 at W5, Belfast, Northern Ireland. Visit the dedicated webpage at https://npcf2023.com to register and find out more about the agenda and participation opportunities.

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Full STEAM ahead for Almac Group’s Primary School Science Initiative

amoreland — Tue, 24 Jan 2023 09:00:00 +0000

The Almac Group is giving almost 1,000 P6 and P7 children from 16 primary schools across Northern

Ireland access to “Science in a Box”, a fun and engaging curriculum-linked science programme.

This is the second phase of Almac’s £45,000 investment in its STEAM box outreach programme which is on track to reach 50 schools and approximately 3,000 children over the next three years.

This initiative is one part of Almac’s overall mission to inspire the next generation of scientists, engineers, and technologists by helping children to learn vital science, technology, engineering, arts and maths (STEAM) skills, sparking their natural curiosity about the world around them.

Dr Frances Weldon, STEM Outreach Manager for Almac Group said: “We are excited to engage with even more schools and pupils this year with this initiative. It delivers fun, interactive Biology-based programmes to P6 / P7 classes and supports teachers in the delivery of the World Around Us curriculum. Over the course of five lessons, the children will learn about the building blocks of life, the human body and how it works.

“As well as increasing their scientific knowledge, this programme will also help to develop creativity, communication and critical-thinking skills. At Almac, we are keen to help children understand that STEAM is for everyone and leads to so many diverse and fulfilling careers right here in Northern Ireland.”

Each of the schools will receive a Science-in-a-Box programme, along with a training webinar, resources and support from staff at Almac and STEAM Education Ltd based in Cork.

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Almac Pharma Services Announces Two Vice President Appointments

admin — Mon, 23 Jan 2023 16:53:00 +0000

Craigavon, Northern Ireland – 23 January 2023 – Almac Pharma Services, a member of the Almac

Group providing innovative pharmaceutical development, manufacture and commercial services, has announced the appointment of two new Vice Presidents. Both will serve on the Almac Pharma Services’ Executive Leadership Team, reporting directly to John McQuaid, President & Managing Director of Almac Pharma Services.

Trevor Clarke has been appointed to the position of Vice President, Analytical Operations, Pharma Services.

Harry Lindenmuth has been appointed to the position of Vice President, Operations Audubon, Pharma Services.

John said: “It gives me great pleasure to announce these two appointments.

“Trevor has been a key member of the team since he joined as a Quality Manager in 2005. He has held various site and global quality leadership roles and has been influential in supporting growth and service expansion of the business. This appointment to the Almac Pharma Services’ Executive team underlines the importance placed on Analytical Operations which underpins so many of the services we deliver to our clients.”

“Harry joined Almac as Audubon Site Director in June 2020. He has been influential in the strong performance of the Pennsylvanian based site with delivery metrics resulting in positive client sentiment and leaving the site well poised for further growth.”

“I look forward to their contribution to our continued success.”

#ENDS#

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

With facilities located in Europe and the US, we provide tailored, quality-led and timely solutions from early and late phase pharmaceutical development, clinical and commercial drug product manufacture, product launch through to commercial packaging and global distribution.

About Almac Group

A unique culture delivering exceptional solutions

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 6,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Pharma Services Recruiting Senior Operators in Charnwood

davidkane — Thu, 12 Jan 2023 15:16:07 +0000

Loughborough, UK – 11 January 2023 – Almac Pharma Services, the global pharmaceutical contract development and manufacturing organisation is recruiting a number of Senior GMP Operators within its Pharmaceutical Manufacturing team at its Charnwood site in Loughborough.

No previous experience is required to join the company at Senior GMP Operator Grade 1 level as full training will be provided, allowing candidates to progress through the Senior Operator grades as their skills develop. Almac also offers opportunities for experienced professionals.

The successful candidates will be supported by Senior Operators and the Operations Management team through a mentoring and training programme, to identify how best to put their unique skills to use. The programme aims to enhance the trainee Operators’ capabilities and assist them to truly shine in their career at Almac whilst making a significant contribution to patient health worldwide.

An open day will be held at 6pm on Wednesday 18^th January, 2023 at Almac’s production facility, in the Charnwood Campus, Woodhouse Building on Bakewell Road in Loughborough. Prospective applicants will have the opportunity to hear more about the roles and tour Almac’s facility. HR representatives will also be on hand to provide advice on completing the application form, and to discuss the benefits included in the programme.

James Hurst, VP of Operations and Charnwood Site Head, said: “At Almac, we are passionate about mentoring our employees to highlight the possibilities that come with their skillset and develop those skills to unlock their potential, career progression and growth. We look forward to welcoming new colleagues to help us advance human health together.”

Jane Hunt, Loughborough MP, said “I am very proud that Almac is based in Loughborough, it is a prestigious company to have at our Charnwood Campus site. The recruitment drive will offer new opportunities to local residents and graduates alike and will give employees the ability to gain new skills and move up the career ladder. Please do go along to the event and find out more.”

Hasan Girach, Senior Operator, Grade 2 said, “As a physics graduate with no experience in the pharmaceutical industry, joining Almac was initially a daunting prospect. However, working alongside skilled operators with a vast array of knowledge, in a fast-paced environment guaranteed new learning opportunities on a daily basis.

“Being trusted to lead projects and operate often complex equipment allowed me to build my confidence, quickly progress in my role and set off my career in the pharmaceutical industry”

Kieran Gillman, Senior Operator Grade 1 said: “I joined Almac without any Pharmaceutical experience. Today I am leading projects, operating complex machines and passing down my knowledge to new employees.

“Almac has given me opportunities I never thought I’d be given and has boosted my confidence and broadened my scope within the industry.”

For details on the information session, please visit: https://www.almacgroup.com/careers/almac-charnwood-operator-career-open-day/

ENDS

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

About Almac Group

A unique culture delivering exceptional solutions.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group says goodbye to Colin Hayburn

davidkane — Fri, 30 Dec 2022 09:22:59 +0000

The Almac Group would like to wish Colin Hayburn every success as he moves on from his position of Executive Director to pursue new challenges on December 31^st 2022.

For over 14 years, Colin was part of Almac Group’s Leadership team and a valued member of the Almac board. He brought a wealth of both strategic leadership and governance experience to Almac during this period of unprecedented growth for the organisation. Colin was also a Trustee of the McClay Foundation.

Alan Armstrong, Almac Group CEO, said: “Colin was highly regarded by his fellow board members and colleagues from across the Almac Group. I would like to thank him for the valuable contribution he made to the organisation. We wish him every success as he leaves us to join Extern as their CEO in early 2023.”

Colin is a Queens University graduate and was awarded an MBE for services to economic development and philanthropy in June 2022.

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Almac Group secures HPRA certification for biologics testing

davidkane — Wed, 14 Dec 2022 15:00:00 +0000

Health Products Regulatory Authority (HPRA) has certified Almac Sciences Ireland (ASI) facility for testing of biologics after a successful audit

Almac Sciences Ireland, a member of the Almac Group, has secured certification from the Health Products Regulatory Authority (HPRA) for biologics testing after a successful audit.

The certification adds to Almac’s existing GMP certificate, renewed in 2022, which covers testing raw materials, small molecules and microbiology. This additional certification enables Almac to perform biologics testing for the determination of product quality attributes throughout the drug development cycle, from development to commercialisation.

The analytical testing lab, based in Athlone, Ireland, provides a comprehensive range of flexible pharmaceutical testing services to support clients’ drug development programmes adhering to industry regulations including FDA, EMA and HPRA under GMP standards.

Almac’s biologic testing services include GMP lot release and stability testing to support clients’ drug substance and drug product programmes for both novel biologics and biosimilars. It also includes fit-for-purpose analytical method development / phase-appropriate method validation; raw material testing for microbial and mammalian expression systems that comply with pharmacopeial requirements and clients’ specifications.

The addition of this biologics certification complements the well-established range of analytical services already offered from Athlone as well as its global headquarters in Craigavon, UK and Almac’s facility in Pennsylvania, North America.

Dr Pavan Kumar Kunala, Biopharma Lab Manager for Almac Sciences said: “I am delighted that our lab has received this HPRA certification which will enable us to offer enhanced analytical testing services to our clients. With the current landscape of increased growth in biologics post-pandemic, Almac’s service offering for biologics testing reiterates the commitment to provide superior solutions in the advancement of human health.”

Dr Simon Cocks, Site Manager of the Athlone laboratory, added: “Achieving this certification is testament to the commitment of the biologics testing team. Biologics have gained huge traction in the last decade and are poised for stronger growth in the coming years, with potential to significantly impact patient lives. We are confident that the addition of this biologics testing certification will continue to strengthen our competitive position in the marketplace.”

ENDS

About Almac Group

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Employees Raise £50,000 for Two Local Children’s Charities

davidkane — Wed, 14 Dec 2022 12:19:34 +0000

Employees from The Almac Group have raised an incredible £50,000 for two local children’s charities, Angel Wishes and the Children’s Heartbeat Trust, enabling them to continue to provide invaluable support to young people and their families across Northern Ireland.

The money was raised through Almac’s annual raffle which offered over 130 prizes.

Elaine Gibson, Almac Group’s Global Travel and Events Manager, said: “We are really pleased that thanks to the generosity of our employees, we have raised £50,000 from the raffle and can donate such a significant sum of money to both Angel Wishes and the Children’s Heartbeat Trust.”

Samantha Coleman, Fundraising Manager for Children’s Heartbeat Trust said: “Thank you most sincerely to Almac and their staff for their generous donation of £25,000 to the vital work of Children’s Heartbeat Trust. Every year in Northern Ireland 200 babies are born with a congenital heart defect. We provide, financial, emotional and practical support to children and their families living with CHD, supporting close to 500 families on a yearly basis, a diagnosis of CHD can be extremely frightening and we are there for families when they need us most. We do not receive any government funding so are indebted to companies like Almac who so generously give to our important work.”

Gaye Kerr, Angel Wishes, commented: “Angel Wishes cannot begin to express our gratitude to Almac for all their generosity and support they have given our charity from day 1. The amount of money raised is phenomenal and will make a huge difference to our families in NI affected by cancer related conditions. On a very personal note, I would like to thank Almac for helping me to keep the legacy/memory of my children Helen (aged 3) and Brian (aged 10) alive through the smiles of others.”

The draw was hosted by Almac Group’s CEO, Alan Armstrong and live-streamed on the company’s intranet.

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Almac Pharma Services Supports Rapid Launch of Provention Bio, Inc.’s Treatment TZIELD™ (teplizumab-mzwv)

davidkane — Tue, 13 Dec 2022 15:00:00 +0000

First and only treatment indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and paediatric patients aged eight years and older with Stage 2 T1D

Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services, has successfully supported the packaging and rapid launch of Provention Bio Inc’s product, TZIELD™ (teplizumab-mzwv) into the US market.

TZIELD* was approved on 17^th November by the United States Food and Drug Administration for intravenous use as the first and only immunomodulatory treatment to delay the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older with stage 2 T1D. Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening.

T1D is an autoimmune disease that occurs when the immune system attacks and destroys the cells that make insulin. People with Stage 3 T1D have increased glucose levels, eventually requiring insulin shots (or wearing an insulin pump) to survive and must check their blood sugar levels regularly throughout the day. Although it can appear at any age, T1D is usually diagnosed in children and young adults.

“At Provention, we look to our manufacturing and operational partners for their strong industry expertise, infrastructure and compliance to regulatory standards to help execute a successful commercial launch,” noted Christina Yi, Chief Operations Officer at Provention Bio. “That’s why we partnered with Almac – our operational partnership supports TZIELD reaching patients across the US and helps us accelerate the depth and breadth of its launch.”

Harry Lindenmuth, Audubon Site Director, Almac Pharma Services commented: “We are pleased to have supported the launch of Provention Bio, Inc.’s first biologic treatment. Our team is delighted to have played a role in packaging this key advancement in delaying the onset of stage 3 type 1 diabetes. Through our relationship with Provention Bio, Inc., the teams worked diligently to develop a plan and implement the most appropriate robust and timely processes, protecting the integrity of TZIELD whilst ensuring it was delivered shortly after FDA approval. Many congratulations to our partners at Provention Bio, Inc. on the development of this treatment.”

#ENDS#

About Provention Bio, Inc.

Provention Bio, Inc. (Nasdaq: PRVB) is a commercial-stage biopharmaceutical company focused on advancing the development and commercialization of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Company’s pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including T1D, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Pharma Services Supports Rapid Launch of Provention Bio, Inc.’s Treatment TZIELD™ (teplizumab-mzwv) appeared first on Almac.

Almac Group Completes First Stage of GMP API Facility Expansion

davidkane — Tue, 06 Dec 2022 12:00:00 +0000

Expanded GMP manufacturing facility now operational for use in clinical and / or commercial manufacturing

Almac Sciences, a member of the Almac Group, has completed the first stage of its GMP API facility expansion in a multi-million-pound investment programme.

An extension to the current API facility situated at Almac Group’s global headquarters in Craigavon, the completed installation hosts an additional 2 x 1000 L Glass Lined Steel Reactors with associated filtration and drying equipment allowing the manufacture of 50 – 100 kg batch API output.

Almac Sciences has grown rapidly over the last five years and this expansion is the latest stage of a multi-million-pound investment programme to support increased client manufacturing demands. The ongoing investment programme will create manufacturing centres of excellence to support small molecule API production at up to 200 – 300kg scale, as well as increased capacity for peptide API production.

The fully operational facility complements the R&D technology centre opened in 2021 for Almac’s established biocatalysis, flow chemistry and peptides businesses.

Dr Dan Bayston, Vice President, Small Molecule API, said: “The investment in this new manufacturing facility has been critical to support the increased demand from our clients. As our business grows, we are experiencing an ever-increasing pipeline of projects taking advantage of our integrated offering from development through to manufacture and are delighted that this expansion provides us with a stronger ability to serve our global customer base.”

Active recruitment to fill production technician, engineering and Quality Assurance positions is well underway to support current and future manufacturing demands. These roles are critical for Almac’s continued success with further opportunities for career progression and growth.

The next phase of development is currently underway with further manufacturing and warehousing expansions which will be announced in due course.

#ENDS#

About Almac Group

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Clinical Technologies announces IXRS®3 as market leading in key industry report

davidkane — Tue, 06 Dec 2022 09:30:00 +0000

Almac Clinical Technologies (ACT), part of the Almac Group, has been ranked as the industry’s most preferred IRT application globally, among recent users in a recent independent survey for their Interactive Response Technology (IRT) software, IXRS®3. 61 per cent of ACT’s recent users chose ACT as the provider they most prefer to use.

Industry Standard Research (ISR)’s ‘IRT Market Dynamics and Service Provider Benchmarking report’, published in October 2022, is designed to help key decision makers across the eClinical ecosphere to stay current with market dynamics and anticipate industry changes. Feedback was assessed from over 100 respondents throughout the professional IRT community, and the results are categorized by IRT supplier performance and preference metrics.

Almac’s IXRS®3 solution was ranked first in the “IRT Vendor Preference” section out of over 20 global companies based on respondents’ experience with the platform. The customer feedback showcased ACT as a top performer in project manager quality, ease of use for the clinical and site teams, reporting and cross study-design functionality.

Used in over 4,000 clinical trials in over 120 countries, IXRS®3 is available to deploy through multiple start up modes and is the most configurable and customizable IRT available. From Phase I through to Phase IV, simple designs to complex adaptive trials, the application can accommodate any permutation of study objectives, and is fully supported by a team of eClinical professionals with supporting services in biostatistics, systems integrations and regulatory compliance.

Valarie Higgins, President and Managing Director, Almac Clinical Technologies said: “These survey results not only affirm Almac Clinical Technologies’ software as the global leader but the data also highlights the importance of the people and expertise behind the technology which is unique to Almac.

“I am proud of the customer service our teams provide for customers, supporting them throughout their IRT journey through a fully streamlined partnership.”

These results reflect the findings of a similar survey that was carried out earlier this year by a third-party provider on behalf of ACT. The results also cement an industry leading position for ACT’s IXRS software on a range of key performance indicators.

Ends

Notes to editor:

ACT is the most popular IRT software provider when comparing provider preference between recent users of a range of IRT companies, with 61% of ACT’s recent users saying that ACT is the company they most prefer to use.

The survey included 108 respondents from North America, Europe and Asia.

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Almac’s Higher Level Apprentice success in WorldSkills UK National Competition

davidkane — Thu, 01 Dec 2022 09:00:00 +0000

Three Almac Group Chemical Sciences Higher Level Apprentices (HLAs) have been successful at this year’s World Skills UK National Competition. Anastasiya Kovtun won bronze and Wiktoria Kurkowska and Abigail Magill both received Highly Commended.

Almac’s Higher Level Apprentice success in WorldSkills UK National Competition

Anastasiya and Abbi from Almac Sciences and Wiktoria from Almac Pharma Services are currently completing their HLA programme through the organisation’s partnership with Southern Regional College. This partnership provides a range of apprenticeship opportunities for students interested in a career at Almac.

Almac’s HLAs competed among 500 finalists at the competition which took place across the UK this week. As a bronze medal winner, Anastasiya may have the opportunity to represent the UK at the “Skills Olympics” in France in 2024.

World Skills UK is an independent charity which partners with employers, education and government and is a member of the global body, WorldSkills, created to support young people via competitions-based training, assessment and benchmarking.

Tanya Graham, Sciences’ Head of Analytical Services, said: “We offer huge congratulations to Anastasiya, Abbi and Wiktoria on their success in the WorldSkills UK development programme. We are delighted for you and extremely proud of the achievement of all our HLAs who competed.

“Almac’s apprenticeship programmes enable students to develop the technical knowledge and skills they need to support projects at different stages in drug development. The support and mentorship we offer our apprentices, as well as the opportunity to take part in competitions like WorldSkills, really helps our apprentices develop valuable interpersonal skills and grow in confidence in their respective roles.”

Almac’s partnership with Southern Regional College has created 66 apprenticeship jobs, over two thirds of whom are still working within the group and we are aiming to train over 100 apprentices by 2025.

ENDS

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Odyssey Trust invests £3 million in state-of-the-art new centre to offer Learning Innovation for Everyone

davidkane — Thu, 01 Dec 2022 08:00:00 +0000

The Odyssey Trust has opened a state-of-the-art learning centre, LIFE at W5, as part of a major extension to its mission to offer Learning Innovation For Everyone.

Representing a capital investment of circa £3million, the facility will support the learning and skills pipeline in Northern Ireland, creating and nurturing future talent for STEM and technology sectors. Working in partnership with industry partners including Microsoft, Almac and Belfast Harbour, the Odyssey Trust anticipates the centre will offer skills-based learning and training programmes and outreach to over 160,000 people over the next five years.

The impressive 20,000sq. foot space occupies the former Bambu Beach Club and is part of the overall reimagining of the Odyssey complex. LIFE at W5 will offer on-site and digital outreach programmes to foster and facilitate opportunities for young people in industries with real and tangible career opportunities.

Particular effort will be made to identify and engage with hard-to-reach schools, young people and adult learners in underrepresented communities, through strategic linkages and direct community engagement work.

Commenting at the opening, Robert Fitzpatrick, CEO, The Odyssey Trust said: “Building on over 20 years of STEM based learning in W5, this dedicated hub will provide a new home for learning, that is welcoming and accessible to all. We wanted to create a space, outside of the realms of formal education, where people from across Northern Ireland could come to learn more about themselves, and perhaps the opportunities they have missed, or may not have considered previously.

“We believe this space has the potential to be a catalyst to properly engage and deliver the new 10x Skills Agenda, that will increase understanding and awareness of technologies and associated careers pathways. Ultimately, we hope to help nurture, develop, and retain talent that will be crucial to our future economic and societal wellbeing. This vision aligns with the charitable objectives of The Odyssey Trust to improve the life chances for people in Northern Ireland.”

Collaborative partnerships with industry will be core to the success of the programmes offered by the new centre, which it is hoped will reach in excess of 40,000 participants each year.

Judith Harvey, Group Head of Education and Public Engagement, Odyssey Trust said: “As a charitable Trust, we want to make a difference. Our programming will focus on accessible and inclusive approaches to gaining employability and life skills, not just for young people, but across all life stages, promoting true lifelong learning.

“Working collaboratively with our founding partners Microsoft, Almac and Belfast Harbour, we are developing programmes that will have a positive impact on people’s lives, whilst addressing the skills gaps needed to grow the NI economy and create jobs. Programmes will have inbuilt progression and industry accreditation opportunities, linked to employability pathways.”

Within LIFE at W5, Microsoft has invested in the creation of a dedicated Microsoft Dream Space experience for the students and teachers of Northern Ireland to access. The fully immersive STEM experience has been developed by Microsoft in partnership with educators to inspire, encourage and challenge students to think creatively in areas such as computer science, AI, Mixed Reality, and robotics.

Speaking about the investment Anne Sheehan, General Manager, Microsoft Ireland said: “At Microsoft, we’re passionate about helping young people to engage in STEM learning and shift their perceptions about the role technology can play in their future career choices. With digital technology reshaping how we live, work, and learn, it is important that young people develop digital skills at the earliest opportunity. That’s why, four years ago we invested in the Microsoft Dream Space experience and just recently announced our commitment to its continued growth and expansion over the next four years.

“We’ve had many students from Northern Ireland based schools both participate in our virtual Dream Space offering and attend our hub at our campus in Dublin, however, it was always an ambition of ours to have a physical Dream Space experience here in Northern Ireland. It’s great to have reached this milestone and to be here today celebrating the official opening. We look forward to our continued partnership with the team at Odyssey Trust and the impact we can have together.”

Almac will build on its work in MED-Lab, W5’s interactive medical themed exhibition area, to develop STEM programmes and career-based learning, exploring potential opportunities in medical and life sciences.

Dr Stephen Barr, Managing Director and President of Almac Sciences and Almac Discovery said: “We are delighted to be a partner with the Odyssey Trust on LIFE at W5. As a business that employs over 6,500 individuals globally, our success depends on the talent and skills of our most important asset, our people. At Almac we know that career pathway decisions can start as early as 10 years of age and so investing in the potential of Northern Ireland’s young people is crucial to developing the next generation of talent.”

As an extension of its community outreach partnerships with the Belfast Giants and W5, Belfast Harbour will support the development of programmes that will serve underrepresented communities.

Joe O’Neill, Chief Executive of Belfast Harbour, said: “As a socially responsible port that is committed to inclusivity, equality and providing a gateway to opportunity for all, Belfast Harbour is excited to support the opening of the new LIFE at W5 centre. The centre’s core objective to create tangible new career opportunities for young people aligns with Belfast Harbour’s own commitment to encourage and support the development of skills and to improve access to employment in our local communities.”

For further information, visit www.w5life.co.uk

ENDS

Notes to editors:

The Odyssey Trust Company is a registered charity and was established to, ‘hold, manage, safeguard and develop the investment in the Odyssey project for the benefit of all the people of Northern Ireland’.
The Odyssey Trust provides educational advancement and Learning activities at W5, the interactive science and discovery centre, and by offering a wide range of recreation and leisure activities and events in The SSE Arena, Belfast, and the Odyssey complex. The Odyssey is widely recognised as one of the most successful millennium projects funded by the Big Lottery in Northern Ireland.
In 2019, the Odyssey Trust acquired circa 20,000 sq. ft of space within the extended footprint of the former Odyssey Pavilion, which was designated as a potential new Learning Centre.
Significant conversations with industry partners led to the development of a plan to deliver this new space, which includes a sustainable recurrent funding model for 10 years.
To date the Trust has invested circa £3m capital in this innovative project.

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Agios Pharmaceuticals Celebrates PYRUKYND® Launch Success with Almac Group

davidkane — Tue, 22 Nov 2022 08:00:00 +0000

First Disease-Modifying Therapy for Hemolytic Anemia in Adults with Pyruvate Kinase (PK) Deficiency

Craigavon, Northern Ireland – 22 November 2022 – Almac Group, the global contract development and manufacturing organisation, hosted a visit from strategic partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, to jointly celebrate the launch of its product PYRUKYND® (mitapivat) in the United States.

PYRUKYND is the first disease-modifying therapy for Hemolytic Anemia in adults with Pyruvate Kinase (PK) Deficiency – a rare, debilitating blood disorder which causes red blood cells to be broken down prematurely. The treatment was approved by the U.S. Food and Drug Administration (FDA) in February this year.

A team from Agios visited Almac Group’s headquarter facility in Craigavon, Northern Ireland, to meet the Almac team responsible for managing the successful clinical trial distribution and rapid multi-SKU launch of PYRUKYND earlier this year.

During its pivotal Phase 3 study, Almac Clinical Services provided global clinical supply chain expertise to assist in bringing PYRUKYND (mitapivat) to market. A full suite of end-to-end clinical supply solutions including clinical packaging, labelling, distribution and QP Services was provided, all while working collaboratively with Almac Sciences and Almac Pharma Services to create a seamless bridge between clinical and commercial development.

Agios then leveraged Almac Pharma Services’ highly experienced and tailored manufacturing and logistics expertise to anticipate and execute the bespoke printing, packaging, labelling, and shipment of multiple batches across the US within hours of FDA approval.

During the visit, Agios presented Almac with the ‘Agios Arete Award’ for ‘thriving to do the absolute best, both in Almac Pharma Services and Almac Clinical Services, one patient at a time’. The term ‘Arete’ is taken from the Greek word meaning ‘living up to one’s full potential and executing with excellence’. The award was created exclusively for Almac by an artist in Massachusetts.

“We were pleased to celebrate the successful launch of PYRUKYND with the team at Almac, and we are so appreciative of their partnership as we worked together to efficiently to bring this new medicine to patients who previously had no options,” said Wendy Xia, Vice President and Head of Supply Chain, Agios. “At Agios, we are fuelled by connections, and Almac’s expertise, collaboration, and unflagging dedication to patients were critical to the seamless launch of this first-in-class medicine for people with PK deficiency.”

The visit marked a key point in Almac Pharma Services’ relationship with Agios, providing the team with the first opportunity to see their product on site before being packed and prepared for shipment.

“We were thrilled to host this visit by Agios which was long awaited due to restrictions imposed throughout the pandemic. To receive recognition in the form of the ‘Agios Arete Award’ for our services is an absolute honour and we are delighted to share in Agios’ success. All credit goes to the multi-disciplinary teams who worked diligently to successfully deliver the timely rapid launch of PYRUKYND to patients in need and support Agios in their commitment to make a difference for people with PK deficiency.” commented Grainne Hughes, VP Business Support Operations, Almac Pharma Services.

Richard Segiel, VP Business Development North America, Almac Clinical Services, said: “We have a strong and developing relationship with Agios and are delighted with this award. Ultimately, we all strive to deliver as best we can to the benefit of every patient on every trial. Successful collaboration across the different teams and functions for both Almac and Agios has resulted in this success. We are so very proud of playing a part in helping treat patients with PK deficiency and look forward to collaborating more in the future.”

#ENDS#

About Agios Pharmaceuticals, Inc.

Agios is a biopharmaceutical company that is fueled by connections. The Agios team cultivates strong bonds with patient communities, healthcare professionals, partners and colleagues to discover, develop and deliver therapies for genetically defined diseases. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for adults with PK deficiency, the first disease-modifying therapy for this rare, lifelong, debilitating hemolytic anemia. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. In addition to its clinical pipeline, Agios has multiple investigational therapies in preclinical development and an industry-leading research team with unmatched expertise in cellular metabolism and genetics. For more information, please visit the company’s website at www.agios.com.

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Hosts Internationally Recognised Chemistry R&D Forum in Belfast

amoreland — Tue, 15 Nov 2022 11:46:33 +0000

Nordic-Irish Process Chemistry Conference re-scheduled to June 2023

Almac Sciences, a member of the Almac Group, has announced that the Nordic Process Chemistry Forum, an internationally recognised forum for leaders in chemistry, will be held in Belfast, Northern Ireland for the very first time in the forum’s history. Traditionally hosted by Nordic-based companies, this move has resulted in the forum being renamed to the Nordic-Irish Process Chemistry Forum in advance of the event, which was originally scheduled to run in May 2020 but rescheduled due to the global COVID-19 pandemic.

As a leader in process chemistry and R&D, Almac Sciences will serve as the host during the forum from 6^th to 8^th June 2023. The Nordic Process Chemistry Forum has a long history of attracting some of the most respected and innovative speakers in the world of chemistry, and the Belfast event will be the 9th event forum.

Since the event was founded in 2004, by a group representing pharma company AstraZeneca and CRO/CMO Syntagon, all based in Sweden, the main driver of the forum has been to bring scientists together who are involved in the design and scale up of chemical processes. The event facilitates networking, addresses pertinent chemical challenges, and fosters idea sharing and hosts new chemical trends. The upcoming event in Belfast is no exception— a fantastic line-up of industrial and academic speakers has been secured for this event, covering a range of subjects within the process chemistry field. A dedicated website has been created for this event (see below) and expression of interest is now open with opportunities for participation.

Professor Tom Moody, VP Technology Development & Commercialisation at Almac and Arran Chemical Company commented: “We have established excellent relationships with the Nordic Process Chemistry industry and are delighted to be entrusted to host this event in Northern Ireland. The rich chemistry expertise and innovative research taking place among industry and academia across the EU and within the island of Ireland will be showcased this at the event. We are delighted to re-schedule this prestigious event and look forward to hosting our guests in Belfast where chemistry will be brought to life.”

Professor Hans-Jurgen Federsel, co-Founder of the Nordics forum, said: “The basic idea behind starting the Nordic Process Chemistry Forum was the feeling that this part of the world was in dire need of a meeting where chemists, notably active in an industrial setting, could meet biannually and share top scientific and technical achievements. Unfortunately, the global pandemic prevented the 2020 event going ahead but I’m personally very happy that my friends at Almac have remained committed to re-organizing the event which will be hosted for the first time outside the realm of the original Nordic countries.”

The Nordic Irish Process Chemistry Forum will be held from 6 – 8 June 2023 at W5, Belfast, Northern Ireland. Visit the dedicated webpage at https://npcf2023.com to register interest and find out more participation opportunities.

#END#

About Almac Group

A unique culture delivering exceptional solutions

Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5,000 highly skilled personnel across 17 facilities including Europe, the US and Asia.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Pharma Services Audubon site receives first product approval by MHRA and Health Canada

davidkane — Tue, 15 Nov 2022 09:18:55 +0000

Global contract development and manufacturing organisation, Almac Group , has announced that after the successful pre-approval inspection (PAI) of its Pharma Services’ operations located in Audubon, Pennsylvania by the US Food and Drug Administration (FDA), the site has received product approval from the US FDA, UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada.

The PAI, conducted by three FDA Investigators last month, resulted in the approval of all three products that were covered by the inspection. The scope of the inspection included both the blistering of a multi-product blister pack as well as two products using stickpack (sachets) packaging which is an innovative new process introduced to the Audubon facility. All three product portfolios were extensively reviewed for 11 days by the investigators with no findings related to these products.

This is a significant milestone for Almac Pharma Services’ Audubon site since its initial FDA site approval in 2013 and is testimony to the company’s confidence that Almac Pharma Services will continue to grow as the global solution provider to the pharmaceutical and biotech industries.

Ian Markwell, VP of Quality at Almac Pharma Services: “It is good to see that the successful FDA inspection earlier this year is paving the way for the approval of the Audubon site to supply products for other markets.”

Almac Pharma Services’ Audubon site provides a range of solutions for blister packs, stickpacks, and kitting. Site capabilities include a semi-automated packaging system which offers a streamlined and efficient semi-automated process for the packaging of complex medical kit components. These bespoke technologies are available to meet the needs in the U.S. market and provide worldwide supply.

#ENDS#

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

With facilities located in Europe and the US, we provide tailored, quality-led and timely solutions from early and late phase pharmaceutical development, commercial drug product manufacture, product launch, commercial packaging through to global storage & distribution.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac announces commitment to be net zero by 2045

brendanhagan — Tue, 08 Nov 2022 08:00:00 +0000

Almac also announces 2030 emissions target – a part of its ongoing environmental strategy 

The Almac Group has today pledged to be net zero by 2045. Today’s announcement also includes the commitment to reduce the Group’s Scope one and Scope two emissions by 50 percent, by 2030.

These commitments coincide with the release of Almac’s 2022 Corporate Social Responsibility (CSR) report, which highlights the Group’s ongoing commitment to their people, the planet and the communities in which they operate.

Within the report, Almac details actions already taken to address energy use, including the accreditation of UK and Ireland sites to the international standard for Energy Management, ISO 50001. A future commitment was also made to roll it out to US and APAC sites in the coming years.

The company has also included a commitment in the report that all new building projects at Almac Group campuses globally will be designed and constructed to Building Research Establishment Environmental Assessment Method (BREEAM) standards (or appropriate global equivalent).

“I am hugely encouraged by the progress that we have made this year as detailed in this report and very proud of the environmental commitments that we announce today.” said Niall Harkin, Almac Executive Director.  

“Almac is proud to publish our annual Corporate Social responsibility report for 2022, which details our commitment to our people, our planet, and the communities in which we operate. The report outlines excellent progress in these focus areas, and looking forward, we will continue to introduce new initiatives to deliver our future ambitions.” said Alan Armstrong, CEO. 

About Almac Group

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Pharma Services Supports Packaging and Supply of PTC Therapeutics’ Gene Therapy Upstaza™ for EU Launch

davidkane — Mon, 17 Oct 2022 13:00:00 +0000

Tailored ultra-low temperature solutions enabled first and only approved disease-modifying treatment for AADC deficiency to be approved by EMA

Craigavon, Northern Ireland – 17 October 2022 – Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services, has successfully supported the packaging and commercial supply of PTC Therapeutics, Inc.’s gene therapy product, Upstaza™ (eladocagene exuparvovec).

Upstaza is the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency and the first marketed gene therapy infused directly into the brain. The product is approved for patients 18 months and older and marketing authorisation is applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein.

Almac Pharma Services began their partnership with PTC to support the Upstaza product introduction in 2019 through its innovative and tailored ultra-low temperature (ULT) solutions. The Almac team, located in Europe, worked directly with PTC to establish a deep understanding of the unique treatment, and every aspect of the special conditions required to handle, store and process the gene therapy product.

Together they agreed an appropriate strategic programme to efficiently, and effectively, prepare the specialised treatment including packaging, labelling and serialisation over dry ice to guarantee product integrity throughout.

“We are proud to partner with Almac to support packaging and supply of Upstaza for people living with AADC deficiency in Europe,” said Kylie O’Keefe, Senior Vice President, Head of Global Commercial and Corporate Strategy, PTC Therapeutics. “We look forward to continuing our partnership with Almac to bring the best innovation from PTC to the people living with rare diseases who are counting on us.”

Grainne Hughes, VP Business Support Operations, Almac Pharma Services commented: “We are delighted to have supported the rapid launch of this ground-breaking gene therapy product which has been marked as a pivotal milestone for AADC deficiency patients. Our ULT specialists understand that each product is unique in its requirements to guarantee its integrity throughout the entire process. Through our established relationship with PTC, the teams worked diligently to develop a plan and implement the most appropriate robust and timely processes, underpinned by Quality Risk Management, to protect the integrity of Upstaza whilst ensuring it was delivered on time. Many congratulations to our partners at PTC on this fantastic achievement.”

In March 2022, Almac announced the expansion of its dedicated Centre of Excellence and offers an expansive storage facility with specialist suites and freezer capacity to enable inventory stock of crucial product supply ready for rapid distribution when required. The CDMO currently provides solutions for over 25% of EU approved/pre-registration advanced therapeutic medicinal products (ATMPs) having processed and QP released over 700 batches to date.

#ENDS#

About PTC Therapeutics, Inc.

PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC’s ability to innovate to identify new therapies and to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC’s mission is to provide access to best-in-class treatments for patients who have little to no treatment options. PTC’s strategy is to leverage its strong scientific and clinical expertise and global commercial infrastructure to bring therapies to patients. PTC believes this allows it to maximize value for all its stakeholders. To learn more about PTC, please visit us at www.ptcbio.com and follow us on Facebook, Instagram, LinkedIn and Twitter at @PTCBio.

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac McKervey Award for Excellence in Chemistry 2022 Winner Announced

davidkane — Wed, 05 Oct 2022 13:00:00 +0000

The Almac Group, has announced that Alex Olsen, from Portadown, is this year’s recipient of the ‘Almac McKervey Award for Excellence in Organic Chemistry.’

Alex, a MChem Chemistrystudent who has begun a year-long industrial placement in Almac Sciences’ Process Development Chemistry group, received his award and a £1,500 bursary towards his tuition fees from Dr Stephen Barr, Managing Director and President, Almac Sciences & Almac Discovery.

Stephen said: “Pursuing a career in science provides graduate Chemists and Chemical Engineers the opportunity and potential to use their skills, knowledge and talent to make a real difference in advancing human health across the world.

“I am pleased to present the Almac McKervey Award to Alex in memory of our esteemed colleague and friend, Tony, whose commendable leadership and kind manner inspired many of us during his long service with Almac.

“Many congratulations to Alex who has demonstrated exemplary performance and commitment throughout his degree to date. I hope, that in receiving this recognition today, he will progress to a long and rewarding career in chemistry.”

Alex said: “I am honoured to receive this year’s Almac McKervey Award dedicated to the inspiring Tony McKervey. My experience with Almac began with a work shadow placement in 2018 organised by Dr Frances Weldon for Sciences and Discovery business units. I am thrilled to be here at Almac and am already enjoying the new chemistry I’m being shown by my co-workers. I know the experience I will receive over this year-long placement will be invaluable to my career in chemistry.”

Alex’s name was added to the perpetual commemorative wall plaque at the David Keir building at Queen’s – a replica of which is displayed at Almac’s global headquarter facility in Craigavon.

The Almac McKervey award was established in 2018 as a commemoration to the life and work of one of Ireland’s most distinguished scientists, Professor Tony McKervey, who passed away in June 2017. A former Professor of Organic Chemistry at both University College Cork and Queen’s University Belfast, Tony founded Almac’s Sciences business unit in 1992 and continued to support Almac as a member of the Sciences’ senior management team until his death at the age of 78.

Professor McKervey was an esteemed academic and an industry expert, having received the ASTRA Award of the Royal Dublin Society in 1986 and the Boyle-Higgins Gold Medal of the Institute of Chemistry of Ireland in 1993. He also authored over 270 published research papers in world-renowned journals.

The ‘Almac McKervey Award’, which is open to students studying Chemistry or Medicinal Chemistry at the School of Chemistry and Chemical Engineering, Queen’s, is presented each year to the top applicant, selected on both their academic achievement and performance at an interview with Almac’s chemistry experts.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 6,000 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Announces New COO and Appoints New Almac Pharma Services MD

davidkane — Tue, 04 Oct 2022 07:00:00 +0000

The Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced the appointment of Graeme McBurney to the Board of Directors in the role of Chief Operating Officer effective 1st October 2022.

Graeme has over 30 years’ experience in the pharmaceutical industry. He joined the Almac Group in 1990 and has held a number of operational and management positions, most recently as Managing Director and President of Almac Pharma Services since 2003.

In his new role, Graeme will be responsible for implementing operations aligned with long term business goals and the Group’s strategies. He will oversee operations of the Group and work with Almac Executives to secure the functionality of the business to drive continued growth.

Almac has also announced today that John McQuaid will succeed Graeme as Managing Director and President of Almac Pharma Services, which provides a range of pharmaceutical development, manufacture and commercial services. John will now be responsible for overall strategic, operational and financial leadership of the Almac Pharma Services business.

John has been with Almac since 1994 and has held a number of management roles including project management, production and quality. He was appointed Vice President of Technical Operations in 2011 where he was responsible for overseeing the strategic growth and development of the Pharmaceutical Development service offering within Almac Pharma Services.

Alan Armstrong, CEO Almac Group, said: “We are delighted to welcome Graeme to the Board at this exciting time as we progress our global growth strategy. His wealth of experience and expertise will be instrumental in supporting our vision and congratulations to John on his new role as he leads Almac Pharma Services.”

Graeme commented: “I am honoured to join the Almac Group Board of Directors and look forward to the next phase of Almac’s evolution as we remain focused on our client relationships and the continued strategic growth of the Group. I also congratulate John on his promotion to MD of Almac Pharma Services. Having worked alongside John for many years, I am confident his technical knowledge and expertise coupled with strategic management experience is the perfect blend to lead and evolve the business.”

This announcement comes just months after the Group announced a £200m global expansion having recorded a £58m (8.6%) rise in turnover from £677m in 2020 to £735m in 2021 and a 5.8% increase in the Group’s average employee figures from 5,466 to 5,783 from October 2020 to September 2021.

ENDS

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

With facilities located in Europe and the US, we provide tailored, quality-led and timely solutions from early and late phase pharmaceutical development, commercial drug product manufacture, commercial packaging through to global storage & distribution.

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Almac unveils new Cryogenic Service Solution for advanced therapy trials

davidkane — Tue, 04 Oct 2022 07:00:00 +0000

Investments in next generation cold chain solutions at the company’s Durham facility exceed $4m

Durham, North Carolina – 4 October 2022 – Almac Clinical Services, a member of The Almac Group, the global contract development and manufacturing organisation, today announces a new state-of-the-art Cryogenic Service Solution within its Durham, North Carolina campus to support cell and gene therapies.

This latest investment from Almac adds to the company’s overall $4m investment to date in innovative cold chain technology in North Carolina. The Cryogenic Service Solution ensures an unbroken chain of custody from product line to patient, for sponsors of advanced therapy trials.

The fully contained GMP suite features sophisticated processing rooms to safely handle, package, and label advanced therapies under cryogenic conditions. Segregated processing rooms with cutting edge cryogenic freezers, capable of storing 40,000+ vials in -150°C to -196°C temperature ranges, will enable biologic materials to be preserved in liquid nitrogen vapor, while offering 100% redundancy to maximise product integrity.

A new cryogenic shipping service completes the offering, using specialist vapor and validated shippers with cryogenic boxes; dispatching products to customer destinations and guaranteeing product integrity throughout transit.

This announcement follows Almac’s unveil of an innovative combination Ultra-Low freezer and cold processing suite also at its North Carolina campus, accommodating 960 ft3 of Ultra-Low temperature sensitive materials.

Donna Christopher, Global Vice President of Operations for Almac Clinical Services explains:

“The continued growth of the cell and gene therapy market represents an incredibly exciting chapter in modern drug development. This growth brings with it significant opportunity across a broad range of therapeutic areas, from oncology to autoimmune diseases and diabetes. Yet the opportunity is not without challenge. The complexity of operating global clinical trial supply chains involving incredibly volatile, high value IMP has the potential to drastically restrict study success.

“Despite the unprecedented disruption caused by the pandemic in recent years, Almac’s mission to invest in the continued advancement of human health has remained steadfast. Almac’s new Cryogenic Service Solution is testament to this and our commitment to customers and the patients they serve, both today and tomorrow. With the complete chain of custody, the Cryogenic Service Solution provides advanced therapy sponsors precise cryogenic conditions at every touchpoint; upholding product integrity and a truly integrated, optimised and patient-centric clinical supply chain experience.”

Almac Clinical Services continues to invest in capabilities, capacity and technology to deliver an innovative clinical supply solution for Advanced Therapy Investigational Medicinal Products. The range of exciting, advanced therapies in clinical development continues to increase across Almac’s global sites in the US, EU and APAC, demanding unique expertise and an end-to-end view of the complete clinical supply chain.

For more information about Almac’s Cryogenic Service Solution, please visit here.

#ENDS#

About Almac Clinical Services

The most comprehensive Global Clinical Supply Chain Solution in the marketplace

Almac Clinical Services has over 30 years’ experience deploying clinical supply chain expertise and a full suite of end-to-end clinical solutions to over 600 Pharmaceutical and Biotech companies worldwide.

Guided by extensive clinical supply experience and expertise, Almac Clinical Services are recognised as one of the leading, multi-faceted, global solution providers within the niche and complex market of clinical trial supply.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac announces Business in the Community membership

davidkane — Thu, 22 Sep 2022 07:00:00 +0000

The Almac Group has joined Business in the Community, Northern Ireland’s Responsible Business Network. Today’s announcement was marked by a visit from Kieran Harding, Managing Director, Lisa McIlvenna, Deputy MD, and Gareth Williamson, Relationship Manager, to Almac’s Global Headquarters in Craigavon.

Joining Business in the Community highlights Almac’s continued commitment to long-term corporate sustainability. Fostering and promoting policies and procedures across the company which support the health and well-being of over 6,500 employees across the globe, as well as creating sustainability in those communities, has always been of utmost importance to Almac.

Alan Armstrong, Almac Group CEO, said: “Almac’s overarching mission is to “Advance Human Health.” This is the driving force behind everything we do as an organisation.

“Businesses here have an important role to play in making Northern Ireland a better place to work and live, by fostering and promoting practices that support the health and wellbeing of employees contributing directly to the sustainability of the local community.

“Not only do we believe that this is the right thing to do, but it’s what helps to make The Almac Group a good neighbour, the best employer, and a strong commercial partner.

“We know that our vision and goals are shared by Business in the Community. This membership gives us an opportunity to support Business in the Community’s sustainability programmes and initiatives. We look forward to working with them as we continue to have a positive corporate impact on the planet, our people and the wider community.”

BITC attendees were given a tour of the Almac campus and buildings, providing them with an in-depth understanding of Almac’s business activities and future plans for the Craigavon Headquarters.

Kieran Harding, Managing Director, Business in the Community NI said: “We are delighted to welcome Almac into membership, understanding the significant impact they have made over the last 50 years. Our members recognise the huge benefits that come from managing their businesses in a responsible and sustainable way, and we look forward to working with Almac Group and supporting them as they continue their responsible business journey.”

ENDS

About Almac Group

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 6,500 highly skilled personnel across 18 facilities including Europe, the USA and Asia. To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Sciences and UCD strengthen collaboration with prestigious SFI grant

evewallace — Tue, 06 Sep 2022 08:00:00 +0000

Development of continuous flow enzyme cascade processes

Almac Sciences, a member of the Almac Group, and University College Dublin (UCD), have been awarded a Science Foundation Ireland (SFI) ‘Frontiers for the Future’ grant.

The €420,000 grant will enable the exploitation, for the first-time, of emerging enzymes such as ene-reductase (ERED) and carboxylic acid reductase (CAR) enzymes in continuous flow reactors to develop new routes to chemical products. Almac Sciences and UCD will work together to establish the use of enzymatic multi-step reactions in continuous flow reactors as readily and widely applicable tools for the sustainable synthesis of fine chemicals.

The project team, co-funded by Almac Sciences, will include one postdoctoral researcher and two PhD studentships over the next 4 years based primarily in UCD. Both PhD students, Ruairi Bannon and Philip Jamieson, have undertaken industry placements within Almac as part of their undergraduate studies. The placement has equipped them with key transferable skills and valuable insights into critical decision-making for flow processes with industrial relevance.

Lead academic at UCD, Dr Marcus Baumann said “This project will further build on our existing collaboration with Almac Sciences, strengthening expertise for continuous flow within Ireland with a focus on enhancing the application of continuous flow within the biocatalysis sphere.”

Almac and UCD have collaborated on various projects over the last few years and have recently been awarded SSPC’s Industry Impact of the Year, recognising their joint development of continuous flow processes using enzymes.

Almac continues to enhance its flow service offering with a completed £500,000 investment to date already in place. This project further establishes Almac Sciences in the field of flow chemistry and builds on novel methodologies applicable for industrial scale transformations.

Dr Megan Smyth, Team Leader Custom and Flow Chemistry, Almac Sciences commented: “Collaborations such as these established with Marcus and UCD are of the utmost importance to us in Almac Sciences. By supporting development of students, we can ensure a pipeline of expertly trained flow chemists in line with our growing capabilities. For Ruairi and Philip, the opportunity to avail of expertise at Almac Sciences and UCD fosters key interdisciplinary skills and research excellence in the area of flow. I am excited to work closely with them both throughout their studies and wish them every success.”

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group’s Dundalk Site Achieves Globally Recognised Health & Safety and Environmental Management System Certifications

allie — Thu, 18 Aug 2022 13:17:58 +0000

A key advancement in Almac’s global Corporate Social Responsibility strategy

Almac’s European Campus in Dundalk has today been recommended for full certification to the International Organisation for Standardisation (ISO) standards 45001 and 14001 after a full UKAS Accredited audit of the Integrated Management System (IMS).

ISO is an independent, non-governmental, international organisation that produces standards to support innovation and provide solutions to global challenges. The standards achieved are globally recognised for Operational Health & Safety and Environmental Management.

The integrated framework provides all managers and employees with guidance and support regarding the management of HSE, from identifying and handling risks to evaluating and continuously improving processes and is continually updated and improved through regular assessments, reviews and internal audits. The certification of our European Campus is part of Almac’s ongoing strategy to roll out ISO 45001 and ISO 14001 certification across the group’s global sites with an ambition to certify Singapore in 2023 and begin the process for our US sites in 2024.

Almac Group opened the Dundalk facility in 2017, as part of its ongoing global expansion strategy to meet client demand. The site is complementary to the group’s existing clinical supply and drug product development operations offered from its global headquarters in Craigavon, Northern Ireland.

Niall Harkin, Executive Director, Almac Group says: “Almac Group is committed to operating as a responsible business and being a good corporate neighbour across all our sites globally. We are therefore dedicated to implementing the highest standards in sustainability, health and safety into our business. Thank you to everyone involved in our success, including all my colleagues at the Dundalk site, and the Global HSE team who supported the preparations and execution.”

###

About Almac Group

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 6,500 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Announces $65M Expansion of North American Headquarters in Pennsylvania

brendanhagan — Thu, 11 Aug 2022 15:00:00 +0000

Capital plan will increase U.S. clinical supply capacity by 60% upon completion in 2024

Almac Group, the global contract development and manufacturing organisation, today announces a $65 million, 100,000 ft²expansion of clinical supply operations at the company’s North American headquarters in Souderton, PA. The capital investment plan increases clinical capacity at the facility by 60%, with additional cold and ultra-low storage and just-in-time processing capabilities which is forecasted to support the industry trend towards biologics and advanced therapeutic medicinal products (ATMPs).

Almac’s expansion will break ground in early 2023 and upon completion, will bring the company’s North American headquarters footprint to a total of 340,000 ft². Capacity will increase specifically in the following areas:

200% increase in 2-8°C Storage:
140% increase in 2-8°C Packaging
100% increase in 20°C Packaging
30% increase in 15-25°C Storage
115% increase in Ultra-Low Storage
100% increase in Just-In-Time Manufacturing

This investment enables Almac to better support the North American market – Robert Dunlop, President and Managing Director, Almac Clinical Services, commented: “Drug development and clinical trials continue to evolve across the world, with sponsors expanding their pipelines to focus on biologics, vaccines and advanced therapy medicinal products. Almac is at the forefront of building supply chain expertise and capacity for this evolution. We are committed to investing in our clients’ future challenges and are delighted that this expansion provides us with a stronger ability to service our growing customer base.”

The North American Headquarters expansion comes on the heels of the company’s July announcement that the overall planned investment in Pennsylvania operations and facilities will total $93.5 million over the next three years and will total over $250 million for the Group globally during the same period.

The company has committed to creating 355 new Montgomery County-based jobs to support the forecasted growth and is actively recruiting for positions across disciplines and experience levels.

Acting Secretary of Economic and Community Development Neil Weaver today visited Almac’s North American headquarters to mark the next chapter of growth for the company and local community.

“It’s a thrill to be here today to see first-hand what Almac has planned for their expansion, and I’m glad that DCED and the Wolf Administration could assist with these plans and invest in this project,” said Weaver. “This project is bringing good paying jobs to the region and shows what Pennsylvania has to offer to companies, especially in the life sciences. This state, and this area, continues to be a worldwide leader in the biotech and life sciences industries.

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Almac, AstraZeneca CDx Partnership Branching Out to New Disease Areas, Drawing on NGS, qPCR

davidkane — Thu, 11 Aug 2022 07:28:36 +0000

Read Almac Diagnostic Services recent genomeweb feature on our CDx collaboration with AstraZeneca in multiple chronic disease indications.

In this article, written by Justin Petrone, hear from Almac on why companion diagnostics business has always been a core service for Almac and how the change in technology focus towards qPCR and Next Generation Sequencing (NGS) is increasing with market demand.

Hear from AstraZeneca, where a precision medicine approach is an integral part of the company’s R&D efforts to develop precision medicines for chronic diseases that make it possible to diagnose and intervene earlier.

Access the full article here.

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Almac Group Expands Laboratory Scale Jet Milling Capabilities for Formulation and Toxicology Studies

davidkane — Tue, 02 Aug 2022 07:00:00 +0000

Craigavon, Northern Ireland – August 2022 – Almac Sciences, a member of the Almac Group, has invested in additional milling capabilities to now provide small scale, non-GMP prototype batches of jet milled material for formulation trials and toxicology studies, including a new Hosokawa Alpine 50AS spiral jet for micronisation of drug substance prepared directly from a tightly controlled crystallisation process.

Jet milling can be an essential process to reduce the particle size of a powder to less than 10 µm. It is also well recognised that by reducing the particle size of a drug substance, the surface area of the powder increases to support faster dissolution or adsorption, subsequently improving its bioavailability. This approach is commonly used for drugs that exhibit poor aqueous solubility or for drugs that are inhaled.

By introducing a Hosokawa Alpine 50AS Spiral Jet mill to Almac Sciences’ toolbox, Almac is now offering small scale non-GMP jet milling on gram to kilogram scale to support the existing GMP jet milling service offering.

Dr Jonathan Loughrey, Physical Sciences Manager, Almac Sciences, commented: “Milling and micronisation are key technologies for pharmaceutical development. Using our experience and knowledge of solid form and formulation development, we are now able to take the next step into providing non-GMP prototype batches of jet milled material for formulation trials and tox studies. By using the existing expertise and available equipment for materials characterization, the Physical Sciences group can now prepare and characterise prototype jet milled batches for direct shipment to our clients or a site specified by them”.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company, commented: “Almac Sciences is a science and technology partner, and we are committed to investing in the latest equipment and key technologies to accelerate drug development. We listen to the needs of our clients and are happy to have closed a capability gap in our existing jet milling and micronisation service offering. Being able to offer this key technology from gram to kilogram scale to support non-GMP drug substance development, we can help to accelerate development of drug substances that may exhibit challenging solubility profiles so life changing treatments may be available to patients faster.”

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Pharma Services Opens Applications for Trainee Production Operator Programme

allie — Mon, 01 Aug 2022 09:32:22 +0000

Applications are open to anyone with A-Levels or an equivalent level 3 standard qualification, including students expecting to receive grades in August.

Almac Pharma Services is recruiting ten Trainee Production Operators within its Packaging Operations team at the company’s global headquarters in Craigavon.

Almac’s Trainee Production Operator programme, now in its second year, give applicants the opportunity to develop their career and progress through various roles within the leading global company.

Applications are open to anyone who is qualified to A-Level or an equivalent level 3 standard qualification, including students expecting to receive grades in August.

An information day will be held at 2pm, 4pm and 6.30pm on Wednesday 24th August at the Seagoe Hotel, Portadown to give prospective applicants the opportunity to hear more about the roles and speak to Managers and current Trainee Production Operators. HR representatives will also be on hand to provide advice on completing the application form and to discuss the benefits included in the programme.

Mark English, VP Packaging and Logistics Operations at Almac Pharma Services, said: “We are pleased to be recruiting for STEM roles that would be suited to school leavers or young adults who have the relevant A-Levels or BTECs.

“At Almac, we are passionate about mentoring our junior employees to highlight the possibilities that come with their skillset and develop those skills to unlock their potential, career progression and growth. We look forward to welcoming new colleagues to help us advance human health together.”

Ben Armstrong, Trainee Production Operator at Almac Pharma Services, said: “The Trainee Operator programme has helped me adjust into a fulltime working environment after just leaving school. Working on the production floor has given me a greater insight into how the company works.

“My colleagues have been very helpful in my first six months in the role, from Operators through to Senior Managers.”

For details on the information session, job specification or to make an application ahead of the deadline on 29^th August. please visit: https://almac-group.rezoomo.com/job/34669/

###

About Almac Group

A unique culture delivering exceptional solutions.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 6,00 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac’s Higher Level Apprentices shortlisted for WorldSkills UK National Competition

davidkane — Wed, 20 Jul 2022 10:57:59 +0000

Three of Almac’s Chemical Sciences Higher Level Apprentices (HLAs) have been named as finalists in this year’s World Skills UK national competition.

Abbi Magill and Anastasiya Kovtun from our Sciences’ business unit and Wiktoria Kurkowska who works within Pharma Services are currently completing their HLA programme through Almac’s partnership with Southern Regional College which provides a range of apprenticeship programmes for students interested in a career at Almac.

They are among 500 finalists who will be competing for gold, silver and bronze at the competitions taking place across the UK in November – those who are successful will then have the opportunity to represent the UK at the “Skills Olympics” in France in 2024.

Tanya Graham, Sciences’ Head of Analytical Services, said: “Congratulations Abbi, Wiktoria and Anastasiya on getting this far in the WorldSkills UK development programme. We are really proud of your achievement and wish you all the best at the upcoming finals.”

“Our partnership with Southern Regional College has created 52 apprenticeship jobs, over three quarters of whom are still working with us and we are exploring additional opportunities with the aim of training over 100 apprentices by 2025.”

ENDS

About Almac Group

The figures quoted in this announcement relate to the financial period 1 October 2020 to 30 September 2021. Employee numbers recorded in the results relates to the average figures during that financial year.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group employees complete Certificate in Customs Compliance

davidkane — Fri, 01 Jul 2022 07:00:00 +0000

Almac Clinical Services is delighted to congratulate Catherine Smyth and Rebecca Fitzpatrick for successfully completing customs training and qualifying as Associate Customs Practitioners.

Customs professionals are granted with the knowledge they require to prepare and lodge customs declarations with HM Revenue & Customs by the Academy of Customs Practitioners. Catherine and Rebecca completed the Level 3 Certificate in Customs Compliance within the one year requirement and received the intermediate qualification following an online curriculum of webinars, videos and step-by-step guides.

Rebecca Fitzpatrick, Customs Compliance Officer, Almac Clinical Services said: “I really enjoyed the course and the exams. I improved my knowledge and had many key takeaways which I use to support my role. I was delighted to get a Distinction grade and I’m looking forward to starting the next level.”

Catherine Smyth, Customs Compliance Officer, Almac Clinical Services stated: “The course was very informative, and it covered a broad spectrum of Customs Compliance Legislation and provides a good base of knowledge for anyone interested in all aspects of Imports/Exports Customs procedures.”

Sharon Courtney, Logistics Services Manager, Almac Clinical Services recognised their achievements: “Almac Clinical Services is delighted to have supported Catherine and Rebecca, to further enhance their knowledge in this specialised area. Achieving Level 3 Certificate in Customs Compliance is a notable achievement, and we look forward to them supporting our global client base in achieving trade compliance. Congratulations and we wish them the best of luck as they move onto completing the next level.”

#ENDS#

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Almac Group to Create 355 Jobs and Invest $93.5 Million in Pennsylvania Expansion

davidkane — Thu, 30 Jun 2022 14:00:00 +0000

Almac Group, the global contract pharmaceutical development and manufacturing organisation, announces today that the company is expanding its North American headquarters in Montgomery County, Pennsylvania and will create 355 new jobs through the project.

Almac Group’s expansion in Pennsylvania will add 100,000 square feet to their existing 246,000-square-foot North American headquarters facility, as well as upgrades at the company’s two other Montgomery County sites, to meet increased and next generation client demand.

The company has operated in Pennsylvania for more than 20 years and officially opened a North American headquarters site in Souderton, Pennsylvania in 2011.

“We are delighted to mark this next milestone of our future in Pennsylvania,” said Alan Armstrong, Almac Group Chairman and Chief Executive. “We look forward to welcoming over 350 new employees, who will be an essential part of our continued success over the next three years. Almac Group’s mission is to advance human health and we are committed to re-investing all of our profits back into the business to ensure we are market leading for our clients and patients and offer the best possible work environment for our people.”

The company received a funding proposal from the Pennsylvania Department of Community and Economic Development (DCED) for a $1.775 million Pennsylvania First grant and a $250,000 workforce development (WEDnet) grant and were encouraged to apply for the department’s Manufacturing Tax Credit (MTC) and Research and Development Tax Credit (R&D) programs. Almac Group has committed to creating at least 355 new jobs, retaining 1,434 existing jobs and investing approximately $93.5 million into the project within the next three years.

This project is the second of Almac Group’s expansion projects under current Pennsylvania Governor Tom Wolf, the first of which was announced in November 2016. Both projects were coordinated by the Governor’s Action Team (GAT), an experienced group of economic development professionals who report directly to the governor and work with businesses that are considering locating or expanding in Pennsylvania.

“It’s truly a testament to what our commonwealth has to offer, when an internationally successful company like the Almac Group chooses to expand its North American headquarters here in Pennsylvania,” said Gov. Wolf. “This is the company’s second expansion during my administration, and I think our pro-business climate has a great deal to do with that. Pennsylvania is a great choice for companies looking to set up shop or businesses already located here who want to grow and thrive for years to come.”

“Almac’s exciting new phase of growth in Montgomery County is a testament to the excellent workforce and exceptional quality of life our communities offer,” said David Zellers, Jr., Director of Commerce, Montgomery Count Commerce Department.

Almac Group is a global company based in Northern Ireland that is at the forefront of developing, manufacturing, testing and distributing essential medicines to vulnerable patients around the world. During this financial year, the group was a partner of choice in the development of over 300 life-saving drugs spanning more than 20 therapeutic areas including oncology, cardiology, immunology, gene therapy and neurology.

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Almac Diagnostic Services collaborates with AstraZeneca to Develop and Commercialise Companion Diagnostics (CDx)

davidkane — Thu, 23 Jun 2022 07:00:00 +0000

CDx programmes initiated under master collaboration agreement

Almac Diagnostic Services, a member of the Almac Group, today announced it has signed a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialise multiple companion diagnostic (CDx) products. Almac will work to support AstraZeneca in its drive to bring new therapies to patients globally in disease areas of high unmet need.

Under the terms of the agreement, Almac will develop and validate specific CDx assays for patient selection in various AstraZeneca clinical trials across a range of therapeutic areas including kidney disease, non-alcoholic steatohepatitis, and respiratory disease. Almac will seek regulatory approval for individual CDx assays in agreed jurisdictions in tandem with linked AstraZeneca therapeutics. To date, a number of programmes have already been initiated under this model.

Professor Paul Harkin, President & Managing Director, Almac Diagnostic Services, commented: “We are delighted to have signed this CDx master collaboration agreement, which represents a further strategic alignment with AstraZeneca, and enhancement of an already strong relationship. We are looking forward to working collaboratively together to develop and commercialise these companion diagnostic tests to help identify the right patient populations that will benefit from future AstraZeneca targeted therapies.”

Maria Orr, Head of Precision Medicine, BioPharmaceuticals R&D, AstraZeneca said: “Precision medicine is at the heart of AstraZeneca’s ambition to dramatically improve patients’ lives globally; it is an interconnected cycle from early research, innovative pharmacology and drug modalities, to clinical trial design and diagnostic development. Through collaborating with our partners we can lead the way in a new era of precision medicines for complex chronic diseases. We are committed to matching life-changing medicines to patients most likely to benefit and we believe our collaboration with Almac will help us achieve this.”

ENDS

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Notes to editors

About Almac Group

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

For media enquiries:

Julie Watts, Almac Group, julie.watts@almacgroup.com

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Almac Group & Indian Valley Education Foundation Cut Opening Ribbon on Student Careers Experience Center at Souderton Area High School

allie — Thu, 16 Jun 2022 11:00:00 +0000

Almac Group today announces the official dedication of an innovative student careers space at Souderton Area High School, marking the culmination of a three-year, innovative community-based partnership between Almac Group, Indian Valley Education Foundation, and Souderton Area School District.

As the cornerstone of the partnership, a portion of the Souderton Area High School library has been remodeled into a “Career & Collaboration Corner” through Almac’s financial support, outfitted with new furnishings and technology to foster collaboration, small group opportunities, and speakers. In addition, Almac also sponsored a hands-on careers exploration experience with students, enabling students to: visit the company’s North American headquarters in Souderton; film, edit, and produce video interviews featuring Almac employees and their firsthand career experiences; and create a digital tool for their peers that maps Almac’s career opportunities to the school’s Pathway 360°program.

Ribbon cutting festivities included remarks from Valarie Higgins, President & Managing Director, Almac Clinical Technologies; RuthE Potter, Executive Director, Indian Valley Education Foundation; school administration; and six students who presented the digital career path tool to the audience.

Remarks were followed by the Office of Congressman Brian Fitzpatrick, presenting a flag flown over the U.S. Capitol in commemoration of the public-private educational partnership.

Almac Group is a leading employer in the Indian Valley and is at the forefront of developing, manufacturing, testing and distributing essential medicines to vulnerable patients around the world. The privately owned company re-invests all profits back into its business and this week announced a $250 million global capital investment plan to meet increased client demand over the next three years, including in North America.

“It is an essential part of our culture and purpose as an organization to invest in the next generation of scientists, engineers and technologists who will continue our mission to advance human health. We are thrilled that Souderton Area High School’s goal to expand and adapt the library into an innovative space for students was achievable through Almac’s sponsorship,” Valarie Higgins, President & Managing Director, Almac Clinical Technologies, said.

“To the students—as a leading employer in the Indian Valley, we have been honored by the opportunity to work with you and share more about what careers are possible in your own backyard. You truly represent the future of our community.”

RuthE Potter, CEFL, Executive Director IVEF said, “We are most proud to see that our students leave the Souderton Area School District prepared to navigate in the world as informed, well-educated, respectful human beings. While those skills are developed within the walls of our schools, they are reinforced through the interactions and opportunities they have with our community partners.”

“Almac has stepped forth to bring their resources and commitment to our school district in a unique and impactful way. We hope this will light a spark with other area businesses to consider their role in positively supporting public education. Creating tomorrow’s workforce begins today.”

ENDS

About Almac Group

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Rising talent receives prestigious £1.5M UKRI Future Leaders Fellowship

evewallace — Wed, 15 Jun 2022 13:00:00 +0000

Further investment set to expand Sciences’ continuous flow platform

Craigavon, Northern Ireland – 15 June 2022 – Almac Sciences, a member of the Almac Group, is delighted to announce Dr Megan Smyth, Team Leader, Custom & Flow Chemistry, has been awarded a highly competitive UK Research and Innovation (UKRI) Future Leaders Fellowship (FLF). The Research and Development grant, worth £1.5 million, funded over a 4-year period, enables further enhancement of innovative continuous manufacturing in tandem with a strong focus on development of strategic leadership thus strengthening the business skills for the Fellow.

The FLF scheme facilitates the development of the next wave of world-class research and innovation leaders for both academia and business. The FLF scheme also supports the Fellows through their ambitious and challenging projects in conjunction with the host organisation.

The project will deliver a platform technology to expand Almac Sciences’ service offering in oxidative chemical continuous processing for the benefit of its global customers. Aerobic oxidations are extremely atom efficient, however fall into a unique category of reactions which are difficult to perform in batch at scale due to safety concerns.

Through horizon scanning it was identified there is a need to the develop an industrially useful oxidative flow platform using air as oxidant. This FLF project will address this need and is necessary for CDMOs like Almac to lead competitively here in the UK.

Dr Megan Smyth commented: “Using flow technology opens up many opportunities to replace traditional stoichiometric oxidants with inexpensive, green and abundant oxygen. Through this grant, my team and I will exploit innovative approaches such as ultrafine bubbles and 3D printing to streamline chemical processing resulting in cost savings for our customers. This oxidative platform will allow us to back integrate raw material synthesis into our manufacturing assets in the UK and Ireland resulting in more secure supply chains.”

Prof Tom Moody VP Technology Development & Commercialisation said: “The overall impact of the project will be diverse and will positively affect the environment, economy and society. It will aid in supporting the competitive edge for the UK chemical manufacturing industry, to securing high skilled jobs for Northern Ireland which will undoubtedly have a multiplier effect. It will also lead to improving sustainability metrics and lowering environmental burden by the essential reshoring of key chemical manufacture to minimise our reliance on Asia.”

Along with exceptional scientific advancements from the innovative research, the Fellowship is a unique programme designed to allow businesses to attract, retain and develop the very best early career innovators delivering new knowledge and understanding and tackling some of the greatest challenges of our time.

Megan added: “I am thrilled to receive this Fellowship which will equip me with a cutting-edge combination of research excellence and transferable management skillsets. The FLF will help to address future economic and societal challenges at Almac Sciences and for the UK. My ambition is to lead a technology platform, driving increased business revenue beyond proof of concept, to manufacture and subsequent supply of chemicals here in the UK. It is an exciting time for me, my team and Almac Sciences.”

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group records highest ever revenue, profit and employee numbers as £200 million global expansion plans announced

davidkane — Tue, 14 Jun 2022 07:00:00 +0000

Almac Group, the global contract pharmaceutical development and manufacturing organisation, has today (Tuesday 14^th June) reported its highest ever end-of-year results for revenue, profit, and employee numbers.

In their financial results for year ending 30 September 2021, Almac recorded a £58 million (8.6%) rise in turnover from £677 million in 2020 to £735 million in 2021. Pre-tax profits were recorded at £81 million, up from £64 million (27.1% increase) for the same period the previous year.

The report also detailed an increase in Almac’s average employee figures from 5,466 to 5,783 (5.8%) during the period of October 2020 to September 2021. Current employee numbers for the Group now sits at over 6,500 and a current global recruitment drive will increase the total number to over 8,000 over the next three years, with over 1,000 of these new roles planned for Northern Ireland.

Privately owned Almac is committed to re-investing all profits back into its business and today announces a £200 million global capital investment plan to meet increased client demand over the next three years.

Investment will take place in existing Almac locations in Northern Ireland, other sites in the UK, Europe, North America and Asia.

Almac is at the forefront of developing, manufacturing, testing and distributing essential medicines to vulnerable patients around the world. During this financial year the group was involved in the development of over 300 life-saving drugs spanning more than 20 therapeutic areas including oncology, cardiology, immunology, gene therapy and neurology. Almac was also instrumental in supporting over 200 research projects for COVID-19 vaccines and treatments.

Alan Armstrong, Almac Group CEO, said: “I am hugely proud of our achievements in the last financial year. I am incredibly grateful to every one of our employees for their part in delivering these outstanding results as we continue our vital work developing life-saving and life-enhancing medicines for our clients and patients.

“Almac is committed to re-investing all our profit back into the business to ensure we are market leading for clients and offer the best possible work environment for our people.

“For our clients, we are investing £200 million on expansion to ensure we remain the global leaders in our industry and give them, and ultimately patients across the world who receive benefit from these therapeutics, the best possible offering from Almac.”

ENDS

About Almac Group

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group launches fully funded degree apprenticeship programme Almac Accelerate

davidkane — Fri, 27 May 2022 07:00:00 +0000

Almac Group has launched its new degree apprenticeship programme, Almac Accelerate, in partnership with Ulster University which will begin in September 2022.

The ‘earn as you learn’ three-year programme aims to kickstart an exceptional career in Almac for four successful candidates. Almac Accelerate combines a fully funded BSc. Honours Degree in Leading on Customer Operations and paid work experience within either Almac Clinical Services’ Project Management or Procurement teams at the company’s global headquarters in Craigavon.

The application process is now live and is open to students with, or who are about to qualify with, a Level 3 qualification. The four available places are funded by the Department for Economy’s Higher Level Apprenticeship programme.

As with Almac’s other award-winning Higher-Level Apprenticeship programmes, this new initiative includes a structured programme of tailored on-the-job training and mentorship to support and guide the apprentices throughout their studies. Almac Accelerate will give students an opportunity to secure a permanent position in the company upon award of their degree and a clear career path into more senior roles across the company.

In addition to a debt-free degree, the successful candidates will also receive an attractive benefits package including a competitive salary, flexible working patterns, annual bonuses and employer pension contributions.

Kelly Neill, Head of Project Services at Almac Clinical Services, said: “Through Almac Accelerate we’re eager to support young adults in developing their business skills and experience, while working towards a very practical degree with truly applicable modules for the workplace.

“With the ever-increasing costs of third level education and the struggle to get hands-on experience, degree apprenticeships are a win-win for both the students and Almac.

“Sir Allen McClay was a huge advocate of supporting jobs in the local community and this apprentice program is a continuation of his legacy. This year will be the start of what we expect to be a hugely successful program that will grow year on year, securing the talent that Almac needs to allow us to continue to excel in the future.”

Ruth Mercer, Course Director at Ulster University Business School said:“We are very excited to partner with Almac to offer this pioneering Degree Apprenticeship. The delivery of customer operations globally is evolving rapidly, and the part-time BSc (Hons) Leading on Customer Operations programme has been designed to equip employers with the next generation of customer-centric leaders.

“Apprentices will benefit from the innovative and job-relevant applied learning, and a rewarding career path. Strategic partnerships, like this, between academia and industry, will continue to play an instrumental role in ensuring the workforce is equipped with the skills of the future. This investment from Almac signals their commitment to creating a diverse talent pool and we’re delighted to support that ambition.”

Advance, Achieve and Accelerate with Almac. To apply, please visit https://almac-group.rezoomo.com/job/31782/

ENDS

About Almac Group

A unique culture delivering exceptional solutions.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Celebrates Earth Day with Habitat for Humanity of Montgomery and Delaware Counties

evewallace — Mon, 25 Apr 2022 13:00:00 +0000

Almac to support and participate in “Rock the Block” Community Clean Up Events

Almac Group, the global contract development and manufacturing organization, is proud to celebrate this year’s observance of Earth Month and support the local community by participating in a key sustainability initiative of Habitat for Humanity of Montgomery and Delaware Counties (MontDelco), Rock the Block 2022.

Habitat for Humanity of MontDelco’s signature “Rock the Block” community clean up events are timed this year to observe and celebrate Earth Day. Citing issues such as combating air pollution and heat-related deaths, as well as improving youth educational performance, mental and physical health and social connections, Habitat for Humanity of MontDelco’s Rock the Block events will also launch the organization’s commitment to plant 500 trees in key revitalization zones by the end of 2022.

Rock the Block is an extension of Habitat for Humanity of MontDelco’s neighborhood revitalization efforts, which work holistically with communities to stabilize neighborhoods, and improve residents’ safety and quality of life.

Niall Harkin, Executive Director at Almac Group, said: “Almac proudly shares Habitat for Humanity of MontDelCo’s commitment to sustainability and building healthier communities. We are honored to play a role in making this year’s Rock the Block event a success, and are proud of our Almac colleagues who have volunteered their time to support the community. We also want to take this opportunity to commend Habitat for Humanity of MontDelco on their inspiring goal to plant 500 trees across Montgomery and Delaware counties this year.”

“Our mission at Almac is to ‘advance human health,’ and therefore, fostering and promoting practices within the business that support the health and sustainability of the communities in which we operate is of utmost importance. We believe that this is not just the right thing to do, but it is also what helps to make Almac Group a good neighbor, the best employer and a strong commercial partner.”

#ENDS#

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Galen expands product portfolio with GelX® Oral Spray

evewallace — Thu, 21 Apr 2022 13:00:00 +0000

Galen, a global pharmaceutical company, and part of the Almac Group headquartered in Craigavon, has announced a new partnership with Sunstar Suisse S.A. to exclusively distribute and commercialise GelX^® Oral Spray in the United Kingdom and Ireland.

GelX^® OralSpray is a product designed to treat Oral Mucositis (OM), a painful inflammation of the lining of the mouth and throat often caused by radiation and chemotherapy cancer treatments.¹ OM increases the likelihood of infection and puts severely immunocompromised patients at risk of sepsis and septicemia.² The collaboration with Galen will ensure that this oncology supportive care product is readily available in a hospital setting for direct use by clinicians to improve the quality of life of their patients.

Galen, which has successfully launched over 100 products in more than 25 locations across the world in a range of areas including medical nutrition, pain management, dermatology and gastroenterology, has developed a global expansion strategy of its product portfolio. This partnership extends the company’s UK and Ireland offering to more treatment areas, providing Galen with a growing hospital portfolio which now includes oncology supportive care as well as respiratory disease and Emergency Medicine.

Galen’s Managing Director and President, Dr Dennise Broderick, said: “Galen is recognised as a partner of choice for specialty pharma companies to launch and promote their products within the UK, Ireland, Europe, US and other global regions.”

“We continually invest in building a portfolio of innovative branded products with global potential in existing and new markets. This new partnership with Sunstar Suisse S.A. to supply GelX^® Oral Spray, along with the recent announcement of our distribution agreement for Provocholine^® (methacholine chloride) are evidence of our ongoing commercial success and expertise.”

#ENDS#

References

GelX^® Oral Spray package leaflet January 2020.
Al-Dasooqi N. et al. Emerging evidence on the pathobiology of mucositis. Support Care Cancer. 2013 21:2075-2083.

About Galen

Established in 1968, Galen is a privately owned pharmaceutical sales and marketing company, headquartered in Craigavon (Northern Ireland), with products in therapy areas including medical nutrition, gastroenterology, pain management and dermatology.

Through organic growth and acquisitions, we have established product sales in 25 locations.

About Almac Group

Galen is a member of the Almac Group. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across, and beyond, the drug development lifecycle to the pharmaceutical and biotech sectors globally.

The international company is a privately owned organisation that has grown organically over the past five decades and now employs over 6,000 highly skilled personnel across 18 facilities including Europe, the US and Asia.

For further information please visit almacgroup.com.

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Almac Group Announces £500,000 Investment in NMR Technology to Enhance Security, Flexibility, and Capacity in Analytical Services

allie — Tue, 12 Apr 2022 08:00:00 +0000

Almac Sciences, a member of the Almac Group, announces a £500,000 investment in nuclear magnetic resonance (NMR) instrumentation at its global Headquarters, Craigavon, UK, marking an over £900,000 total investment in NMR technology for the organisation since 2018.

High-resolution NMR is a key enabling technology that delivers advanced characterisation and purity assessment abilities in line with regulatory requirements. The service helps deliver comprehensive solutions that support drug substance (API) and drug product development programs, from early phase to commercialisation.

Almac’s investment includes the addition of a second 500MHz NMR system, which has been added to further expand the current service offerings within of Almac Sciences’ state-of-the-art cGMP facility. This will boost Almac’s well-established NMR testing service already available to clients, while also increasing through-put, capacity, and speed to enhance efficiency and turnaround times.

The second 500MHz NMR instrument installation at Almac combines Bruker’s cutting-edge Avance Neo platform with a Prodigy Cryoprobe. This set up provides improves capacity to analyse nuclei from 15N to 31P to high sensitivity and resolution, in addition to the running of 2D and quantitative NMR experiments. It also provides additional security for urgent analyses, additional processing capabilities, and superior data integrity controls to ensure increasing regulatory compliance needs are met.

Dr John Malone, Analytical Manager, Almac Sciences said, “The additional NMR technology installation in our cGMP lab allows increased security, flexibility and capacity enabling us to provide an enhanced service to our clients.”

Dr. Darren Thomas, Vice President, Almac Sciences commented “Almac Sciences is committed to ensuring our investments are future-proof and enable us to seamlessly meet our clients’ needs that exist not just today, but in the future. By continuing to invest in NMR service offerings, we’re delighted to offer our clients cutting-edge technology that supports their product safety imperative and accelerates the drug development cycle”

#ENDS#

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Galen expands product portfolio with Provocholine® (methacholine chloride)

davidkane — Mon, 11 Apr 2022 11:44:28 +0000

Galen, a global pharmaceutical company, and part of the Almac Group headquartered in Craigavon, has acquired the rights to Provocholine^® 100 mg Powder for nebuliser solution (methacholine chloride), manufactured by Methapharm Specialty Pharmaceuticals of Canada, to exclusively distribute and commercialise this product in the United Kingdom.

Methacholine chloride 100 mg Powder for nebuliser solution is used by healthcare specialists in patients aged 17 and over to detect bronchial airway hyperreactivity, to assist in the diagnosis of asthma.¹ Approximately 5.4 million people in the UK receive treatment for asthma² which equates to over £1bn being spent annually on treatment and care.³ Approximately one third of these patients are reported to have been misdiagnosed.⁴ Using methacholine chloride 100 mg Powder for nebuliser solution in direct challenge testing could eliminate a misdiagnosis.

Galen, which has successfully launched over 100 products in more than 25 locations across the world in a range of areas including medical nutrition, pain management, dermatology and gastroenterology, has developed a global expansion strategy of its product portfolio. This partnership extends the company’s UK offering to more treatment areas, now including respiratory disease.

“This new partnership with Methapharm to supply Provocholine^®highlights our commitment to continually invest in building a portfolio of innovative branded products with global potential in existing and new markets.”

Chris Calenti, Executive Vice Presidentof Methapharm stated “We are delighted to confirm our new distribution partnership with Galen which extends Provocholine^® availability in the UK”.

#ENDS#

References

Provocholine 100 mg Powder for nebuliser solution (methacholine chloride), UK Summary of Product Characteristics. August 2020. https://mhraproducts4853.blob.core.windows.net/docs/9b1847f453148fd7dc52b3a0d1c1a5905c09a037.
Asthma UK, Slipping through the net: The reality facing patients with difficult and severe asthma, July 2018. https://www.asthma.org.uk/support-us/campaigns/publications/difficult-and-severe-asthma-report/#:~:text=Of%20the%205.4%20million%20people,and%20bespoke%20support%20and%20treatments
Asthma UK, Asthma UK study estimates that asthma care costs at least £1.1bn per year, August 2016. https://www.asthma.org.uk/about/media/news/asthma-uk-study-1.1bn
Kavanagh J. et al. Over- and under-diagnosis in asthma. Breathe (Sheff). 2019 Mar;15(1)e20-e27. https://breathe.ersjournals.com/content/15/1/e20.

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Almac Clinical Technologies Launches OVERSIGHT Trial Data Integrity Monitoring System

allie — Thu, 31 Mar 2022 12:00:00 +0000

New system offers on-demand visibility to the data history of kits, subjects, and sites

Almac Clinical Technologies , a member of the Almac Group and global provider of Interactive Response Technology (IRT) for the biopharmaceutical industry, today announces the launch of OVERSIGHT Trial Data Integrity Monitoring System, available as an add-on suite to the company’s IRT platform, IXRS®.

The OVERSIGHT system provides on-demand visibility to the data history of Kits, Subjects, and Sites within the IXRS—enabling sponsors to identify data integrity issues through audit trail reviews before they can impede a study. It was developed in direct response to new regulations, namely—guidance from the MHRA, FDA and 2021 draft guidance from the EMA—that has expanded the responsibility and accountability of sponsors in maintaining trial data integrity.

Using OVERSIGHT, sponsors are empowered to proactively flag negative trends and performance outliers to keep studies compliant and audit-ready 24/7. It allows on-demand access to study data to identify risks, via quick and easily digestible summary and detailed data views, and filtering capabilities, to support Sponsors with their processes and procedures around periodic review and risk identification and remediation.

“The audit trail is an integral part of any e-clinical system and should be utilized as a tool to drive data reviews forward,” said Cheryl Kole, Head of Solutions Strategy and Commercialization at Almac Clinical Technologies. “Using OVERSIGHT, sponsors can take control of data integrity considerations at a critical first point of entry, before potentially discrepant data is pushed to downstream systems.”

“As both regulatory guidance and technology capabilities continue to evolve, both systems and processes must stay up to speed. Almac is committed to helping sponsors navigate evolving regulations and we’re excited to offer OVERSIGHT as a proactive solution to keep studies compliant and audit ready, minimizing the risks of impeding studies and impacting patients who rely on receiving the right medication at the right time.”

For more information about OVERSIGHT, visit here.

#ENDS#

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Almac Group Clinical Supply and Commercial Solutions Support Agios’ Road to FDA Approval

allie — Tue, 22 Mar 2022 13:00:00 +0000

Almac Group welcomes U.S. FDA Approval of First Disease-Modifying Therapy for Hemolytic Anemia in Adults with Pyruvate Kinase (PK) Deficiency

Almac Group, the global contract development and manufacturing organisation, is proud to confirm it has supported Agios Pharmaceuticals, Inc., a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, in the clinical trial and rapid commercial launch of PYRUKYND® (mitapivat).

The treatment is the first ever U.S. Food and Drug Administration (FDA) approved, disease-modifying therapy for adults with hemolytic anemia caused by PK (pyruvate kinase) deficiency, a rare, debilitating, and lifelong form of anemia.

Almac’s engagement with Agios began in 2014, while the treatment was under clinical study. During the pivotal Phase 3 study, Almac Clinical Services provided global clinical supply chain expertise to assist in bringing AG-348 / PYRUKYND® (mitapivat) to market. Almac Clinical Services provided a full suite of end-to-end clinical supply solutions including expert packaging, labelling, distribution and QP Services, all while working collaboratively with Almac Sciences and Almac Pharma Services to create a seamless bridge between Clinical and Commercial.

Most recently, Almac Pharma Services, which specialises in product development and commercial services, provided rapid launch commercial services in anticipation of FDA approval. This bespoke, proactive service leverages Almac’s highly experienced and tailored manufacturing and logistic expertise to anticipate and execute the bespoke printing, packaging, labelling, and shipment of a drug within hours of U.S. Food and Drug Administration Approval from the company’s Craigavon, Northern Ireland global headquarters.

Dr Robert Dunlop, Managing Director & President, Almac Clinical Services, states, “We send our congratulations to Agios on the FDA approval of PYRUKYND®, we hope this outstanding achievement will significantly improve the quality of life for patients who are living with this debilitating disease. We are proud to have supported this important clinical study and to work in partnership with Agios to deliver crucial supplies to trial patients. I would like to thank those within Almac Clinical Services who worked extremely efficiently to ensure timelines were met and product was delivered on time.”

Graeme McBurney, Managing Director & President, Almac Pharma Services, commented, “We are delighted to congratulate Agios on the FDA approval of PYRUKYND®, a remarkable step forward for patients who suffer from PK deficiency. As an organisation with a mission to advance human health, we have been honoured to support this work that addresses an unmet medical need and provides an unprecedented therapy for those patients who need it most. I would also like to thank our team at Almac Pharma Services, whose ongoing dedication has enabled the seamless, rapid launch of this product into the U.S. commercial space.”

“We are grateful to the team at Almac for their dedication to providing the highest quality service and care for people with PK deficiency in our clinical trials and those who are now getting access to the commercial product for the first time,” said Wendy Xia, Vice President Supply Chain, Agios. “Almac shares our deep commitment to supporting and partnering with the PK deficiency community, and with their collaboration, we have been able to expediently and seamlessly bring PYRUKYND® from the clinic to patients who previously had no approved treatment option.”

#ENDS#

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Almac Pharma Services Expands its Unique Ultra-Low Temperature Solutions for Advanced Therapy Medicinal Products

thomasdrake — Mon, 14 Mar 2022 08:30:00 +0000

Tailored service enables processing and QP release within 20 hours

Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services, has expanded its state-of-the-art Ultra-Low Temperature commercial packaging, labelling and distribution solutions to support the launch of Advanced Therapy Medicinal Products (ATMPs) from its European Centre of Excellence.

Almac Pharma Services was one of the first European CDMOs to support Gene Therapy product launches and currently provides solutions for over 30% of EU approved/pre-registration ATMPs having processed and QP released over 600 batches to date. The specialist team offers its global clients a wealth of expert knowledge, deep understanding, and unique partnerships enabling the processing and release of tailored treatment in as little as 20 hours.

Almac’s bespoke solutions of Just-in-Time labelling, packaging and serialisation at ultra-low temperatures
(-20°C to -80°C) has been enhanced to offer clients a uniquely tailored experience ensuring every step of the highly complex process is adjusted to meet the specific requirements of both the client and the valuable product. In addition, a dedicated team of fully qualified and licenced QPs is on hand to provide expert advice on every aspect of ATMP launch offering a bespoke end-to-end consultancy service.

Robert Smith, Fellow of the Royal Pharmaceutical Society of Great Britain and Consultant QP to Almac Pharma Services noted, “As a result of the nature of these therapies, QP release of ATMPs requires an advanced level of knowledge, training and certification to ensure they understand the biological processes and the variability this brings. It is imperative, therefore, to partner with an experienced CDMO – like Almac – to facilitate and expedite this crucial stage and have confidence that product will be delivered to the patient as quickly as possible.”

Almac’s proven track record and expertise in temperature-controlled logistics combined with its long-established relationships with reputable, experienced and trusted global supply chain providers offers clients a comprehensive end-to-end service guaranteeing expedited delivery direct to patient. Almac’s use of innovative shippers, temperature monitors and digital platforms which enables real-time visibility into product and shipper conditions, as well as location of the shipment, ensures product will not be compromised during transit.

The dedicated Centre of Excellence is located in Europe and offers an expansive storage facility with specialist suites and freezer capacity to enable inventory stock of crucial product supply ready for rapid distribution when required.

The market for ATMPs is forecast to expand through the foreseeable future. Indeed, some industry analysists predict as much as 20 percent year-on-year growth through 2025.

Mark English, VP Packaging & Logistics for Almac Pharma Services commented: “These products are high value and, in some cases, lifesaving medication. The specialist handling, packaging, delivery, and administration of ATMPs is highly complex and time sensitive. Often, patients require treatment within days of diagnosis and therefore any delay or product degradation during any stage of processing or delivery could have devastating consequences for their health.

“We are cognisant that we implement robust and timely processes, underpinned by Quality Risk Management and designed to protect the integrity of the product whilst ensuring it gets to the patient on time.

“Through our work with a variety of ATMPs, we understand that each product is unique in its requirements to guarantee its integrity throughout the entire process. Through our deep understanding, experience and tailored offering, we work in close partnership with our clients to identify and agree the most appropriate methods to meet their needs.

“These innovative and personalised treatments rely on packaging and labelling over dry ice to help prevent temperature excursions and limit the time out of condition. As such, our specialist teams are highly trained and work with precision along each critical step of the operation.”

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Almac supports Belfast Telegraph Business Awards Category – ‘Excellence in Corporate Social Responsibility’

davidkane — Fri, 11 Mar 2022 09:39:00 +0000

Almac Group is at the forefront of developing, manufacturing, testing and distributing essential medicines to vulnerable patients around the world.

Headquartered in Craigavon, Almac employs over 6,000 highly skilled personnel in 19 facilities across the globe including Europe, the US and Asia, over 3,600 of whom are in Northern Ireland.

Sustainability and protecting our employees, clients and communities is central to Almac Group’s ethos. We are committed to being good global neighbours by reducing our own environmental footprint and through the development of green technology to ensure that together with our clients, we achieve a low-carbon future.

Niall Harkin, Executive Director at Almac, said: “Almac Group’s overarching mission is to “Advance Human Health.” This is the driving force behind everything we do as an organisation. Fostering and promoting practices within the business that support the health and wellbeing of our employees and the sustainability of the communities in which we operate is of utmost importance. We believe that this is not just the right thing to do, but it is also what helps to make Almac Group a good neighbour, the best employer and a strong commercial partner.

“Our focus on supporting the health and wellbeing of our local communities has been especially important during the global pandemic. During the pandemic Almac has been instrumental in providing support to over 200 separate research projects for COVID-19 vaccines and treatments through a range of our service areas within very tight timeframes.

“Also during the same period we were honoured to partner with 33 charitable organisations, chosen by our employees, to financially support the health and welfare of our neighbours in each of our corporate locations and beyond.

“Being the best employer in Northern Ireland and across our 19 global locations is an extremely important aspiration to Almac and we are proud to have recently been named Best Apprentice Employer of the Year within our area. We are committed to the personal and professional development of each employee, from our higher level apprentices to operations, senior staff and management level roles, up to and including senior director level.

Niall continued: “We are pleased to support the CSR category at this year’s Belfast Telegraph Business Awards, to reward a company which has made a significant, positive impact through its involvement in a specific programme or initiative designed to make a demonstrable difference to the community.

“Particularly throughout the last two years, there is no doubt we have all developed a deeper appreciation of and commitment to the communities in which we live and work. I can imagine there will be a great number of strong entries showcasing that drive.”

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Almac Group Partners with Irish American Business Chamber & Network to Promote International Business & Life Science Sector Growth in Greater Philadelphia

allie — Wed, 09 Mar 2022 00:40:22 +0000

Almac Group, the global contract pharmaceutical development and manufacturing organization, is delighted to partner with the Irish American Business Chamber & Network (IABCN) to support two key programs that aim to promote international business and life science sector growth in Greater Philadelphia.

As part of the partnership, Almac has supported IABCN’s annual Ambassador Awards, recognizing individuals and companies who exemplify the Chamber’s mission to promote international business and education in Greater Philadelphia.

Almac will also support the IABCN’s Life Science Forum, an annual discussion on topics impacting Greater Philadelphia’s life science sector. This year’s event on April 5 will feature a discussion with Stephen Klasko, MD, MBA of Thomas Jefferson University and Jefferson Health, and will be moderated by George Tiger, Vice President of Global Business Development, Almac Clinical Technologies.

Almac Group is headquartered in Northern Ireland and at the forefront of developing, manufacturing, testing and distributing essential medicines to vulnerable patients around the world. In 2016, Almac became the first Northern Ireland-based company to win the prestigious Ambassador Award, as result of significant growth and economic contribution to the region.

Kevin Reid, Global Vice President of Marketing and Corporate Development at Almac Group, said: “Almac Group is proud of the continued success and milestones we have reached in Greater Philadelphia. We have welcomed over 1,500 members of staff to our three Montgomery County sites, expanded our innovative offerings for clients in the life science sector, and most recently, supported over 200 COVID-19 programs across the globe. We thank IACBN for their ongoing support of our local growth and are delighted to support them in their mission to promote prosperity in Greater Philadelphia.”

Lisa Maloney, President, IABCN, said: “We are proud to have Almac Group as a member of IABCN and as a thriving Northern Ireland-based life science company growing in Greater Philadelphia. Their local success exemplifies why our mission to strengthen the business and educational ties between the island of Ireland and the United States is important to our community. We are glad to have their support for our Ambassador’s Awards and Life Science Forum programs and look forward to a continued prosperous future together.”

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Almac Celebrates International Women’s Day

lorrainemcclay — Tue, 08 Mar 2022 09:00:00 +0000

Almac is marking International Women’s Day by celebrating the significant contribution that women make to the global firm at all levels and through all disciplines.

Dr. Sue Bill, Almac’s Global VP of Human Resources, explains: “The roles we fulfil range from higher level apprentices, through senior staff and management level roles, up to and including Executive positions across a wide range of disciplines including Operations, Project Management, IT, Sciences and Quality .

“As females we are thriving in an environment that supports diversity and hires the best person for the job whilst at the same time offering flexibility in how we work and career progression in what we do. It is an exciting time for Almac with the global growth we continue to experience, and I would encourage women to see what we have on offer.

“With over 600 positions open for application, across 266 different job roles, predominantly at our HQ in Craigavon, including 20 positions in the North West, the opportunities for personal and professional development within the company are extensive. Currently making up nearly 50% of our total workforce, it would be great to see more women enter our employment, to share in the experiences that many of us are already benefitting from, as we support our mission to advance human health.”

ENDS

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Almac scoops the prize for Best Apprentice Employer of the Year at ABC Business Awards

davidkane — Tue, 01 Mar 2022 16:31:03 +0000

Almac Group has been named Best Apprentice Employer of the Year at the recent Armagh, Banbridge and Craigavon Business Awards.

This award recognises our ongoing commitment to the growth and development of our apprentices and the contribution and success that apprenticeships have brought to the company.

Almac Group has a long and consistent track record of recruiting apprentices, helping them to develop their knowledge and skills while contributing to our business through theoretical and work-based learning.

Almac’s partnership with SRC since 2016 has created 52 apprenticeship jobs, 39 of whom are still working for the company. 13 higher level apprentices were recruited in 2021, almost twice the number of 2020. Our vision is that within the next three years, Almac will have trained over 100 apprentices in collaboration with the SRC.

Kevin Reid, Global Vice President of Marketing and Corporate Development for Almac Group said: “The judges told us we won because our apprenticeship programme is clearly central to the future growth and development of the overall company. They recognised Almac’s significant, long-term investment in time and effort to ensure that not only do our apprentices develop their skills, but that they also thrive within the business.

“We are delighted to win this award and congratulations to everyone across the business who contributes to the success of our award winning apprenticeship programme, enabling us to be exceptional together.”

#ENDS#

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Full STEAM ahead for Almac Group’s Primary School Science Initiative

davidkane — Tue, 01 Mar 2022 09:00:00 +0000

Almac Group has partnered with STEAM Education Limited to give Primary 7 children across Northern Ireland access to “Science in a Box”, a fun and engaging curriculum-linked science programme.

Almac is distributing 24 of these boxes, valued at £500 each to 12 schools in 2022 and will continue the initiative each year covering different primary schools. Almac hopes that 50 schools and approximately 3,000 children will participate in the programme over the next 3 years.

This new initiative is part of Almac’s mission to inspire the next generation of scientists, engineers, and technologists by helping children to learn vital science, technology, engineering, arts and maths (STEAM) skills, sparking their natural curiosity about the world around them.

Dr Frances Weldon, STEM Outreach Manager for Almac Group said: “We are excited to launch this new initiative to deliver fun, interactive Biology-based programmes to P7 classes and support teachers in the delivery of the World Around Us curriculum. Over the course of five lessons, the children will learn about the building blocks of life, the human body and how it works.

“As well as increasing their scientific knowledge, this programme will also help to develop creativity, communication and critical-thinking skills. At Almac, we want to help children understand that STEAM can be fun and that there are so many diverse and fulfilling careers available to them, right here in Northern Ireland.”

Each of the schools will receive a Science-in-a-Box programme, along with a training webinar, resources and support from staff at Almac and STEAM Education Ltd.

STEAM Education Limited, the Cork-based company who supply the Science-in-a-Box programmes devised “Science in a Box” to teach a fun and engaging science program to children in primary school with new innovative materials.

Alice D’Arcy, Managing Director, STEAM Education Ltd said: “Supporting enhanced science education at primary level is critical to developing better career pathways for children in the STEAM sector. We are delighted to be working with Almac to support children to reach their potential, to enhance their awareness of amazing opportunities for STEM careers in the region, and most importantly to love learning science!”

ENDS

About Almac Group

A unique culture delivering exceptional solutions.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 6,000 highly skilled personnel across 19 facilities including Europe, the US and Asia.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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New paper reveals Thermodynamic Control Key to Achieving Crystallisation Goal for Psilocybin

allie — Tue, 22 Feb 2022 08:00:00 +0000

Almac Sciences, a member of the Almac Group, is proud to publish a peer-reviewed article in collaboration with Usona Institute. The article, published by American Chemical Society publication ACS Omega, investigates the improvement of the crystallisation process for synthetically produced Psilocybin— a naturally occurring hallucinogenic chemical found in some species of mushrooms.

Psilocybin is a serotonergic agonist given “breakthrough therapy” status by the United States Food and Drug Administration for clinical trials involving major depressive disorder and treatment-resistant depression. The article published by Almac and Usona Institute investigated the applicability of a crystal engineering technique to improve the physicochemical properties of Psilocybin as a pharmaceutical ingredient in the scale up of the compound.

Dr Jonathan Loughrey, Physical Sciences Manager, Almac Sciences, commented: “The collaborative efforts between Usona Institute and Almac Sciences’ Physical Science team highlighted the challenge associated with the kinetic crystallisation of psilocybin, therefore, developed a thermodynamically controlled crystallisation process from water. This process afforded the correct anhydrous polymorphic form with the desired particle size distribution and improved impurity profile. What made this study all the more impressive was that an anhydrous form of psilocybin, Polymorph A, was prepared while two other forms (a metastable anhydrate, Polymorph H, and trihydrate, Polymorph B) were avoided by carefully tuning the crystallization and drying processes.”

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company said:  “Almac Sciences is committed to developing the medicines of tomorrow. Using our combination of advanced analytical techniques and detailed technical knowledge of crystallisation and polymorphism, Almac Sciences’ Technology Group again show our ability to evaluate and mitigate the risks associated with the isolation of the targeted form of psilocybin. We are delighted to showcase collaborations with our customers and continue to produce publication quality results even when faced with the added handling constraints of schedule 1 controlled drugs.”

The article, “Psilocybin: Characterization of the Metastable Zone Width (MSZW), Control of Anhydrous Polymorphs, and Particle Size Distribution (PSD),” can be read here: https://pubs.acs.org/doi/10.1021/acsomega.1c06708

#ENDS#

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Almac Group Actively recruiting in the North West

davidkane — Fri, 18 Feb 2022 09:00:00 +0000

Almac Group is actively recruiting to fill another 20 new posts across their Information Systems, Clinical Services and Clinical Technologies teams based at the company’s facility in Northland Road Business Park, Derry/Londonderry.

The new positions cover a mixture of project management, software engineering, clinical supply and design management positions at all levels. Experience of the pharmaceutical industry is not an essential requirement for these roles as full on-the-job training is provided.

Almac’s strategic expansion plan to develop its operations within the North West is well underway. The infrastructure is now in place, enabling the company to move to a new intensive phase of recruitment to fill these highly skilled job roles across three areas of the business.

Since the announcement in June 2021 to set up a facility in Derry/Londonderry, Almac has recruited 10 new employees covering a variety of roles including Project Group Managers and Clinical Supply Managers for Clinical Services’ Project Services department, Software Engineers for the Information Services team, and Software Developers with Clinical Technologies.

Alan Armstrong, CEO, Almac Group, said: “These 20 new posts, alongside the ten that we have already filled mean that we are well on our way towards meeting our goal of recruiting 100 employees at our new location in the North West by the end of 2024.

“Almac is experiencing significant growth and filling these roles will bolster our ability to continue to support our many clients across the globe. We are proud to have our global Headquarters in Craigavon and we are very pleased that we now have an established base in Derry/Londonderry.”

Mayor of Derry City and Strabane District Council Alderman Graham Warke has welcomed news of additional new job opportunities locally with Almac. Encouraging applicants to avail of the opportunity to work with a global company of such a high calibre, Mayor Warke said Council was delighted to be working alongside Almac in its recruitment drive and was supportive of its efforts to expand its workforce to employ the pool of educated and skilled people in the city and district.

He said: “I am delighted at Almac’s success to date and excited at their level of ambition for growth for the future. It is great to see highly skilled job opportunities being made available and wish the company well in this latest recruitment drive. I look forward to seeing the company further expand and wish them continued success in our city and district.”

Almac is a global contract development and manufacturing organisation with over 6,000 employees located in 19 locations across the world, 3,600 of whom are based at its global Headquarter campus in Craigavon.

To find out more or to apply for a position, visit almacgroup.com/northwest-jobs

ENDS

About Almac Group

A unique culture delivering exceptional solutions.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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The College of Paramedics Opens Dr John Hinds Scholarship Call for Entries

allie — Tue, 01 Feb 2022 11:25:02 +0000

The College of Paramedics, in association with Galen, the privately-owned pharmaceutical sales and marketing company is pleased to announce that applications for this year’s Dr John Hinds Scholarship Award will open on Monday 31^st January 2022. The recipient will win a place on the much-coveted Anaesthesia Trauma and Critical Care (ATACC) course and have their case study published in the College of Paramedics’ magazine, ‘Paramedic INSIGHT’.

The recipient of the scholarship will take up a fully funded place on ATACC’S three-day course in the UK, widely accepted as the most advanced trauma course currently available in the world. Associated travel costs will also be covered. Entrants are required to write a case study which should be written to protect patient confidentiality, using original text, and with all appropriate references included. It must be countersigned by a paramedic colleague who is prepared to confirm that your submission is a genuine case study.

This scholarship is presented in memory of the late Dr John Hinds, who was regarded as an inspirational leader by paramedics and emergency medical technicians and indeed by anyone with an interest in pre-hospital care within Ireland. A world-renowned critical care physician, Dr Hinds gave a huge amount of his own time to educating and supporting paramedics and ambulance staff throughout the Island of Ireland. He died in 2015 following a motorcycle accident.

Dr Dennise Broderick, Managing Director & President, Galen, said: “This award is not only a fitting and lasting tribute to Dr Hinds, but it also provides a unique opportunity for healthcare professionals to advance their expertise and gain access to a globally recognised, highly coveted training programme. Dr Hinds was a pioneering leader in the field of emergency trauma care who dedicated his life to helping others and Galen is extremely proud to support this annual scholarship programme in his honour.”

Imogen Carter, Executive Officer for Policy Development at the College of Paramedics said: “The College of Paramedics is proud to host this award in the name of Dr John Hinds, with Galen’s generous support. We look forward to receiving many high quality clinical case studies from responders across NI and ROI by the 21^st March, a closing date for all College awards, picked as a tribute to Dr Hinds on what would have been his birthday.”

Last year’s recipient, Edel Mullen of National Ambulance Service in Ireland commented: “There’s so much I can say about the ATACC course, I don’t even know where to begin.

“As a newly qualified paramedic, I felt I came away with so much. The knowledge and experiences I gained from ATACC would have taken me years to gain by myself working on the road. I was a part of a really amazing team (Team Orange). They were skilled, enthusiastic and so much fun. It really made for an exciting weekend.

“It was great to be around like-minded people who were so eager to share their knowledge and help you improve your practice.”

Submissions must be made using the Dr John Hinds Scholarship Award Entry Form – link and submitted via email to awards@collegeofparamedics.co.uk by 1200hrs on Monday 21^st March 2022. Submissions will only be accepted by applicants from Northern Ireland or the Republic of Ireland. The College Honours and Awards Committee will then select the winning piece. Due to restrictions imposed as a result of COVID-19, the recipient will be given more details of how the 2022 award will be presented, as soon as they are decided

Submissions should be 750–1,000 words, excluding references and appendices. As a condition of the award, the recipient will be required to submit their case study for publication in Paramedic INSIGHT magazine which has over 20,000 subscribers, along with a follow-up article that describes their experience on the ATACC course.

#END#

Notes to editors

About College of Paramedics

The College of Paramedics is the professional body for all paramedics in the UK, whose role is to promote and develop the paramedic profession across England, Scotland, Wales and Northern Ireland. Membership is open to all UK paramedics, student paramedics and anyone with an interest in the paramedic profession and healthcare delivery. All members, access to a wide variety of learning resources that provide high quality continuing professional development (CPD) across a range of platforms and also at many events held around the UK.

About Galen

The company plans to continue expanding its portfolio with selected specialty products on an international basis. By combining innovation in product development with competitive pricing, Galen aims to work in partnership with healthcare professionals and patients to create real, long-term value. Visit: www.galen-pharma.com

About Almac Group

Almac’s innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture, product development and marketing.

The international company is a privately owned organisation that has grown organically over the past five decades and now employs 6000 highly skilled personnel across 19 facilities including Europe, the US and Asia.

For further information please visit almacgroup.com.

About The ATACC Group

The ATACC Group is a medical and specialist led organisation principally driven by people with a background in health care, UK emergency services and associated professional industries. They are trusted providers of education and training courses to a wide variety of healthcare professionals and emergency care providers. In addition to education and training provision they offer medical oversight and clinical governance services to UK emergency services and emergency response teams.

For further information please visit https://www.ataccgroup.com

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Almac Group Recognised in Life Science Leader CMO Awards for the Eighth Time

allie — Tue, 01 Feb 2022 08:00:00 +0000

Almac Pharma Services, a member of the Almac Group, has been named as a winner of the CMO Leadership Awards for the eighth time. The global contract manufacturing and development organisation which offers a comprehensive range of tailored solutions from pharmaceutical development to commercial services were named as a top performer in both the Quality and Compatibility categories.

The CMO Leadership Awards recognises top performing CMOs, celebrating outstanding companies in drug development and manufacturing emphasising high standards of quality, integrity and innovation exemplified in their work. Almac Pharma Services received two awards based on its global reputation for excellence built over 50 years of client service across the drug development and commercialisation lifecycle.

Industry Standard Research Contract Manufacturing Quality Benchmarking research is conducted annually via an online survey and winning CMOs are chosen based on impartial feedback from sponsor companies that utilise outsourcing services. For the 2022 CMO Leadership Awards almost 90 contract manufacturers were evaluated on 23 performance metrics. CMOs must meet the minimum threshold of customer survey responses to be eligible for an award.

Graeme McBurney, President and Managing Director, Almac Pharma Services, commented: “I am delighted that Almac Pharma Services has been recognised by the prestigious CMO Leadership Awards once again. It is especially poignant at a time when we have all faced unprecedented challenges brought about as a result the COVID-19 pandemic. Winning this award in both the Quality and Compatibility categories is testament to the continued efforts of our global team to ensure we deliver best-in-class, tailored and timely solutions to our clients, and their patients”

The CMO Leadership Awards offers accurate and reliable customer feedback to provide support in choosing a reputable partner for development and manufacturing needs within the biopharmaceutical and pharmaceutical industry.

“Congratulations to all the Life Science Leader and Outsourced Pharma 2022 CMO Leadership Award winners. You are the biopharma industry’s top service providers – those who have exceled for your customers through pandemic hurdles, supply-chain challenges, and advancing demands of new platforms and technologies. An award in any category – capabilities, compatibility, expertise, quality, reliability and service – is one recognized throughout the industry,” added Louis Garguilo, Chief Editor and Conference Chair, Outsourced Pharma.

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn.

About the CMO Leadership Awards

Now in its 11th year, Outsourced Pharma and Life Science Leader’s CMO Leadership Awards provide readers with accurate and reliable customer feedback to assist them in choosing a reputable partner for their development and manufacturing needs. For the 2022 CMO Leadership Awards, Industry Standard Research determined the award recipients through their evaluation of more than 86 contract manufacturers. These CMOs were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. For more information about the awards, visit the awards website.

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Almac Diagnostic Services’ claraT Report Assists Researchers In Uncovering New Oncology Findings

davidkane — Wed, 08 Dec 2021 08:00:00 +0000

Publications from US and UK-based researchers could lead to better future therapeutic outcomes in brain and breast cancer

Craigavon, N.I., Wednesday 8 December 2021 – Almac Diagnostic Services, a member of the Almac Group, is delighted to announce that its unique software driven solution for gene expression data analysis – claraT – has assisted oncology researchers at The University of Arkansas for Medical Sciences (US) and Queen’s University Belfast (UK) in the study of brain and breast cancers. The studies, recently published in the MDPI Cancer Journal and the British Journal of Cancer, have the potential to lead to better therapeutic outcomes for patients.

The research teams, led by Dr Analiz Rodriguez at the University of Arkansas for Medical Sciences and Dr Stuart McIntosh at Queen’s University Belfast, cite use of Almac’s claraT report as a key method used to uncover new findings in their oncology studies.

Almac’s claraT report assists in the analysis of gene expression data by classifying the most biologically relevant gene expression signatures into a comprehensive easy-to-interpret report that covers all 10 Hallmarks of Cancer.

In Dr Analiz Rodriguez’s study, claraT was utilised as a method to facilitate the molecular profiling of brain metastases. Together with other genomic and transcriptomic tools, claraT helped identify novel molecular subtypes and new drivers of brain cancer progression in parallel to novel drug targets. These findings have been published in the MDPI Cancer Journal.

Dr Rodriguez said “We are grateful for the Almac Group’s claraT platform as it allowed us to evaluate hundreds of gene expression signatures and single gene targets that correlated to the Hallmarks of Cancer. Transcriptome data can be difficult to analyze, especially in our heterogenous dataset which included brain metastases samples from various primary cancer subtypes. The claraT software solution immensely simplified our workflow and helped us identify a novel subgroup of brain metastases which warrants further investigation.”

Dr McIntosh’s study at Queen’s University Belfast demonstrated that the Almac DNA-damage immune-response (DDIR) assay could be used to identify a group of breast cancer patients more likely to benefit from DNA damaging chemotherapy prior to surgery. The team then used transcriptome profiling and the claraT report to demonstrate that patients with low baseline immune signalling or “cold” tumours could be immune primed through the prior use of DNA damaging chemotherapy, potentially sensitizing these tumours to immune checkpoint therapy. Taken together, these results could help refine the treatment of breast cancer patients and lead to better therapeutic outcomes. These results have been published in the British Journal of Cancer.

Dr McIntosh said “The increasing use of neoadjuvant chemotherapy for breast cancer has great potential to benefit patients, but there is a real need for validated biomarkers to identify those patients who will benefit from it. Furthermore, although there is increasing interest in the use of immune checkpoint therapies in breast cancer, we still don’t know which patients are likely to respond, nor what the best accompanying chemotherapeutic regimen is to sensitise patients to these. The use of Almac’s claraT report in our study has given us a valuable insight into the underlying biology of breast tumours before and during neoadjuvant chemotherapy, allowing us the potential to develop studies with a sound scientific rationale to further improve outcomes for these women.”

Professor Richard Kennedy, Global VP and Medical Director, Almac Diagnostic Services stated: “We are delighted to be able to equip leading cancer researchers like Professor Rodriguez and Dr McIntosh with a valuable gene expression analysis platform which has supported the identification of exciting new data in their studies. We congratulate them and their teams on their recent publications and look forward to seeing how their studies progress towards new therapeutic interventions in both brain and breast cancer.”

To see the current list of publications, posters and presentations that Almac’s claraT report has assisted research institutions with. Please see: https://www.almacgroup.com/diagnostics/claratreport/publications

ENDS

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Almac Sciences Shines the Light on Corning Collaboration

allie — Mon, 06 Dec 2021 08:00:00 +0000

Getting to the HEART of continuous flow photochemical reactions

Craigavon, Northern Ireland – 6 December 2021 – Almac Sciences, a member of the Almac Group, has announced a technology collaboration with Corning Incorporated, one of the world’s leading innovators in materials science, to utilise Corning® Advanced-Flow™ Reactors (AFR) within Almac’s Technology Centre at its global Headquarters in Craigavon, NI. The collaboration will enhance Almac’s existing capabilities in photochemistry and will further unlock difficult-to-perform photooxidations in flow, which will build further development capacity for Almac Sciences global clients.

Compared to traditional batch reactors, Corning’s AFR technology is an inherently safer technology for the production of chemicals in the pharmaceutical, specialty and fine chemical industries. The technology is specially designed to enable the conversion from traditional batch to continuous flow chemical processing for lab to industrial-scale production. The core of AFR technology is Corning’s integrated fluidic module with its patented HEART design, which is meticulously engineered out of glass or silicon carbide materials to allow for rapid and seamless scale-up, as well as improved heat transfer and mass transfer (mixing).

Dr. Philippe Roth, Application Engineer, Corning Advanced-Flow Reactors, said, “Our collaboration with Almac Sciences allows us to support cutting-edge research and development activities in photooxidation and showcases further examples of how our equipment can be used successfully for such transformations.”

This collaboration will help to further enhance Almac’s technology platform and flow chemistry expertise, which has the potential to unlock new synthetic routes and strategies that are not always possible using conventional batch processing and that are often more cost effective, safer and better control the quality of the product.

Dr. Megan Smyth, Team Leader, Custom and Flow, Almac Sciences, commented, “We are excited by the opportunity to collaborate with the team at Corning as we develop photooxidations. We are keen to build upon our existing in-house expertise while continuing to expand the scope of our flow-technology platform.”

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Almac Group Reaffirms Commitment to Reducing Global Plastic Pollution

allie — Wed, 24 Nov 2021 08:00:00 +0000

About Almac Group

Almac holds “Engaged Member” Status with Acclaimed Sustainability Program

Craigavon, Northern Ireland – 24 November 2021 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is proud to announce that the company has enhanced its engagement with the Responsible Plastics Management (RPM) Program, an internationally recognised, not-for-profit membership organisation set up by certificate and sustainability experts to tackle the plastic pollute crisis.

As an engaged member, Almac will receive direct guidance from RPM on potential performance improvement measures to implement across the organisation in the area of plastics management, as well as strategies for promoting the responsible use of plastics with employees and the greater community. RPM’s recommendations leverage over 20 years’ experience of auditing and managing ISO 14000 series Standards and ISO 17065 Product and Systems Certification, the international gold standards for sustainability.

Commented Niall Harkin, Executive Director, “The plastic problem, if left unresolved, is contributing to pollution in our oceans, hazards to wildlife and threatening our human health and water security. As a global business with a mission to advance human health, Almac Group takes our corporate social responsibility to minimise these risks very seriously. We look forward to leveraging the vast expertise of RPM to promote the reduction, re-use and recycling of plastics at our facilities and across our global supply chain.”

For more information on Almac’s commitment to Corporate Social Responsibility, click here.

#ENDS#

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Almac Group to Create 1,800 New Jobs Globally

allie — Mon, 08 Nov 2021 13:00:00 +0000

Significant investment drives expansion offering opportunities over next 3 years

Craigavon, N.I. – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is planning to recruit 1,800 new jobs across its global operations over the next three years.

These new jobs include operational, supervisory and managerial roles across its business and offers an exciting variety of opportunities for both graduates and experienced candidates alike. Positions are available immediately across 120 different job roles at its sites in the UK, Ireland, North America, Singapore, Japan and the Nordic region.

The company, which marked 50 years in business in 2018, is at the forefront of the development, manufacturing, testing and distribution of essential medicines to vulnerable patients across the globe. Over the past 18 months, Almac has been instrumental in providing support to over 140 separate crucial research projects for COVID-19 vaccines and treatments through a range of service areas.

Almac Group has experienced continued growth in revenue and employee numbers annually over the past 15 years and with significant investment in expansion projects planned over the next three years, the company will see its headcount rise to 8,000 across its 19 facilities globally. Earlier this year the Group reported £677.3 million turnover for its financial year 2019/20 – an increase of £43 million (6%) from the previous year.

With 100% of the Group’s profits reinvested into the business, Almac has already committed to a number of significant expansion and improvement projects across its sites. These new roles will support this ongoing investment.

Alan Armstrong, Almac Group CEO, commented: “Almac’s mission is to “advance human health” and we are proud to be supporting so many global clients as they develop their life-saving treatment for patients in need.

He continued “As demand for our services steadily increases, our aim is to continue to grow our global team by actively recruiting 1,800 new individuals across a wide variety of diverse and exciting areas. These roles come with a range of benefits including flexible working, competitive salary and an annual bonus. Crucially this offers individuals the chance to help us continue our provision of solutions whilst making a real and positive contribution to health right across the world.”

To find out more, visit almacgroup.com/careers.

ENDS

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Almac Sciences and Irish Manufacturing Research Collaborate to Enhance Flow Chemistry Expertise

allie — Tue, 02 Nov 2021 08:00:00 +0000

Innovative 3D printing solutions to design novel flow reactors

Craigavon, Northern Ireland – 2 November 2021 – Almac Sciences, a member of the Almac Group, has initiated a new flow chemistry collaboration with Irish Manufacturing Research (IMR) to design and 3D print novel flow reactors and static mixers. The planned project takes advantage of the design freedom of Additive Manufacturing (AM, an industrialised approach to 3D printing) to make bespoke reactors allowing previously unobtainable chemistry plausible.

Flow chemistry is gaining momentum in its application within the pharma industry by unlocking reaction chemistry not possible in traditional batch mode. At Almac, exploiting continuous flow technology aims to offer clients the best available technology to meet their demanding processing needs of today whilst securing manufacture for the future, by expediting the development of processes where the target chemistry is inherently difficult to scale due to safety concerns.

IMR is a leading manufacturing Research and Technology Organisation (RTO) with labs and industrial pilot lines in Ireland. IMR’s ambition is to accelerate the implementation of key elements of Ireland’s industrial strategy and enable Irish based manufacturers to be early adopters of new technology.

Lead collaborator at IMR, Tristan McCallum said: “I am very excited about our collaboration with Almac Sciences where, with our expertise at IMR, we can support Irish industry to design and produce AM reactors and mixers locally; using the advanced additive manufacturing capability here in Ireland.”

Dr Megan Smyth, Team Leader, Custom and Flow Chemistry at Almac Sciences commented: “This collaboration enables us to move to the next step of our flow chemistry service allowing immediate access to printed reactors with unique properties. This project will ensure we continue to offer our customers best-in-class technical solutions to address the many challenges that contract chemistry brings. As an industry, we need to develop innovative manufacturing routes that opens up access to new raw material supply chains with more secure and mature options. Flow chemistry can assist with this and we are delighted to be progressing it with IMR.”

Earlier this year, Almac Sciences invested over £5million to establish its R&D centre to support increased client demand for its established biocatalysis, flow chemistry and peptides solutions. ”

#ENDS#

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Dr Richard Turkington Joins Almac Diagnostic Services to Support Biomarker Research

allie — Thu, 07 Oct 2021 13:23:39 +0000

Craigavon, Northern Ireland – 7 October 2021 – Almac Diagnostic Services , is delighted to announce Dr Richard Turkington has joined its management team as UK Medical Director to further support biomarker research and clinical trial delivery.

Bringing together academia, industry and healthcare stakeholders, this unique collaboration creates alignment of academic insight and industrial capability in the field of personalised medicine. As part of the Innovate UK funded Innovation Scholar award, the appointment will see Dr Turkington, who is currently Clinical Senior Lecturer in Medical Oncology at the Patrick G Johnston Centre for Cancer Research, Queen’s University Belfast and an Honorary Consultant at the Northern Ireland Cancer Centre, join the Almac team for three years.

As medicine is transitioning from a ‘one-size-fits-all’ approach to more personalised treatments, it is clear more robust biomarker tests are needed to guide treatment decisions. Richard has over 10 years’ experience in personalised medicine and leads an academic research group focussed on improving outcomes for patients with oesophageal and gastric cancer through biomarker-led clinical trials. During his tenure, Dr Turkington will be integral to the validation of new biomarkers and their implementation in international clinical trials in collaboration with Almac’s pharmaceutical industrial clients.

He commented: “I am delighted to join the team at Almac Diagnostic Services and hope that the array of experience I have can help build upon the excellent foundations that are already in place. As a biomarker expert and clinical triallist, the addition of my role will enhance the excellent research and development carried out by Almac Diagnostic Services in biomarkers and support our goal of providing personalised treatment for patients globally.”

Professor Paul Harkin, Managing Director & President, Almac Diagnostic Services said: “Dr Turkington’s wealth of experience and insight into precision medicine is a true asset to our team and we are delighted that he is joining us. His unique position will see him working at the intersection of academia and industry which will benefit the wider healthcare infrastructure and ultimately patients by providing effective, precise and tailored treatments.”

ENDS

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Almac Group Procurement Professionals Achieve Chartered Institute of Procurement & Supply (MCIPS) Designation

allie — Tue, 05 Oct 2021 07:00:00 +0000

Craigavon, Northern Ireland – 5 October 2021 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is delighted to announce that six of the organisation’s employees from across the Group have achieved the prestigious Member of the Chartered Institute of Procurement & Supply (MCIPS) designation, after completing an intensive study and training programme delivered by the Chartered Institute of Procurement & Supply (CIPS). The MCIPS distinction is an internationally recognised qualification that represents the global standard within the profession for procurement and supply professionals.

The programme was the only one of its kind in Northern Ireland and was tailored specifically to meet the complex requirements of the Group. The Almac cohort members began their journey towards this distinction in September 2018, beginning at “Practitioner” level, followed by an 18-month period at “Advanced Practitioner” level. During this time, cohort members participated in interactive workshops to bring views and opinions from across the supply chain, mastered practical assignments on concepts learned within the areas of Strategic Supply, Category Management and Contracting Excellence and completed live business projects which facilitated the implementation of measurable improvements directly into the Almac organisation.

Participants of this intensive program, who have graduated with professional qualification and the designation ‘MCIPS’ are:

• Aidan Reynolds

• Michael Rainey

• Peter Livingstone

• Linda Tug

• Deborah Thompson

• Andrew Hughes

Support from Almac and Invest Northern Ireland made this cohort of the Chartered Advanced Practitioner Programme possible. In addition to the six Almac participants, a participant from Northern Ireland Water also joined the cohort, making it viable for the programme to be delivered locally in Northern Ireland.

Commenting Thomas Crawford, Group Head of Procurement, Almac Group, said “Almac fosters a culture of continuous learning and improvement and it is therefore always a priority for us to seek avenues to develop our employees professionally. We are delighted that, with the support of Invest Northern Ireland, we have supported the development of our Procurement team through the pursuit of the internationally recognised award that represents the global standard for procurement professionals. After three rigorous years of study, we congratulate our Graduates on a job well done and look forward to the improvements they will promote within our organisation.”

#ENDS#

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Almac Sciences and UCD Announce PhD Scholarship

allie — Tue, 05 Oct 2021 07:00:00 +0000

Academic/industry collaboration to further enhance flow chemistry expertise

Craigavon, Northern Ireland – 5 October 2021 – Almac Sciences, a member of the Almac Group, has has announced expanding collaborations with University College Dublin (UCD) for flow based-oxidation approaches through a co-funded PhD scholarship.

Almac Sciences and Dr Marcus Baumann have an already well-established partnership through a Science Foundation Ireland (SFI) Industry Fellowship on the Continuous Biocatalysed Chemicals (CATCH) project which was publicised in 2020. Together the team has published six peer-reviewed papers focusing on the development of continuous flow approaches to demonstrate the synergies between technology platforms, such as flow chemistry and biocatalysis. Highlights include development of Curtius rearrangements under flow and demonstration of the synergies attainable with biocatalysis with a novel enzyme mediated purification strategy.

The new PhD scholarship is co-funded by Almac Sciences and the SFI Research Centre for Pharmaceuticals (SSPC) over the next 4 years and will investigate flow-based oxidation processes. This year’s student, Niamh Disney, will undertake industry placements within Almac, offering an immersive experience on which she will build key transferable skills and gain insight into critical decision-making for flow processes on an industrial scale.

Lead academic at UCD, Dr Marcus Baumann said “I am very excited to continue to work with Almac Sciences and publish further as we investigate novel oxidative approaches under continuous flow. It affords further extension of my research portfolio in industrially relevant fields.”

This latest development demonstrates further Almac’s commitment to technology innovation as it continues to expand service offerings for the pharmaceutical, biotechnology, life sciences and fine chemical sectors following a £325,000 investment, specifically in flow capabilities.

Dr Megan Smyth, Technical Leader, Almac Sciences commented: “This PhD further intensifies our collaboration with the Baumann group at UCD and we look forward to working with Marcus and Niamh. Through close collaboration, and time with us at our state-of-the-art facilities, Niamh will gain a valuable insight into industrially relevant target transformations and I wish her every success with her studies.”

#ENDS#

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Almac Sciences and Queen’s University Belfast Collaboration Successfully Flows Through Mid-point

allie — Wed, 22 Sep 2021 07:00:00 +0000

Continuing to expand technology capabilities through Innovate UK funded Knowledge Transfer Partnership

Craigavon, Northern Ireland – 22nd September 2021 – Almac Sciences, a member of the Almac Group, has successfully reached the midway point of its continuous flow technology project made possible through an Innovate UK funded Knowledge Transfer Partnership (KTP) in partnership with Queen’s University Belfast.

The aim of the Innovate UK funded KTP is to further enhance established flow technologies platforms at Almac Sciences. The technology will be used for development and manufacture of key raw materials and unlock capacity to perform challenging chemical transformations. The KTP scheme supports business growth through identification of new skills and transfer of the latest academic concepts to deliver a strategic innovation programme.

Modular flow technology for continuous manufacture of chemicals is one of the most exciting technologies in the international pharmaceutical and fine chemical industries. There have been significant efforts in the design of flow equipment and processes globally which includes multi-phase flow reactors, gas/liquid mixers and structured catalysts to offer manufacturing flexibility and robustness in continuous production of chemicals.

The Almac team is now delighted to report its KTP project has passed the mid-point with multiple successful outcomes including dissemination through peer-reviewed publication and several conference presentations detailing the development of a continuous flow packed bed catalytic process for hydrogenation of aromatic nitrobenzoic acids to produce corresponding anilines.

Academic Supervisor, Dr Haresh Manyar, Senior Lecturer in Chemical Engineering at QUB, commented “The hydrogenations under investigation are more efficient, less consumptive and safer than the corresponding batch process. Various industrially important aromatic anilines were produced in excellent yields with high throughputs. A continuous flow approach meant no evidence of genotoxic intermediates and, with the modular reactor design, it can be scaled to produce several kilos without extensive redesign.’ He added ‘This unique collaboration with Almac Sciences is a key milestone for Catalysis research at QUB and we are delighted to work together to advance flow technology within an industrial setting.”

For Almac Sciences, the KTP has a positive reach through increasing competitiveness and productivity with a recent investment of £325,000 in continuous flow, including flow hydrogenation capabilities of up to 100 bar pressure and 300°C. Dr Megan Smyth, Technical Leader, Almac Sciences discussed the positive impact the KTP project has had on the expansion of service offerings within the Technology Group adding, “the ongoing successful knowledge transfer has allowed Almac to deliver kilogram manufacture of product for our customers.”

Dr Scott Wharry, Custom and Flow Chemistry Manager and Company Supervisor, Almac Sciences said “Research and innovation are at the heart of what we do on a daily basis within our Technology group. This KTP project has not only increased capacity but has allowed in-depth understanding on which we can build a platform capability which will underpin future process development and further innovation. I wish the team continued success and look forward to seeing the final outcome of the project.”

#ENDS#

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Apex Friendship Graduate Receives Inaugural $50,000 Scholarship from Almac Group

davidkane — Thu, 02 Sep 2021 13:00:00 +0000

Scholarship established in partnership with Triangle Community Foundation to support next generation

Durham, North Carolina – 2 September 2021 – Almac Group is delighted to announce that Khadeeja Ali Syeda, a 2021 graduate of Apex Friendship High School, has been selected as the recipient of the inaugural Almac Group Scholarship, and will receive $50,000 over the next four years.

After an independent review by Triangle Community Foundation’s seasoned scholarship committee, Khadeeja was named this year’s recipient due to her impressive academic performance and involvement in the community, interest in pursuing a STEM career, and powerful personal statement. She will attend North Carolina State University and will receive, in addition to tuition assistance, mentorship opportunities and unique exposure to Almac Group’s career opportunities in the global pharmaceutical and biotech industry.

Commented Donna Christopher, Global VP of Operations, Almac Clinical Services, “Almac and the McClay Foundation support students in overcoming barriers to education across the world, and I am so pleased that we have expanded our reach to create opportunity here in the Triangle region. On behalf of Almac, we are excited to offer the inaugural Almac Group Scholarship to Khadeeja Ali Syeda, whom we had the recent pleasure of meeting at our facility in Durham prior to her first day at North Carolina State University. She is an impressive student who is well-prepared to succeed, and we look forward to continuing to forge a relationship with her as we provide support to help chart her success during her college career and beyond.”

Commented Khadeeja Ali Syeda, “”I would like to thank Almac for their generosity. This scholarship will alleviate much of the financial burden I had due to the cost of my education, and will make it easier for me to pursue my goals. I am honored to have been the recipient of this award, and I am excited for the opportunities it will open up for me in the future.”

The Almac Group Scholarship Fund was established in Spring2021 in partnership with Triangle Community Foundation to support a substantial, multi-year scholarship award for a selected first-year college student in the Triangle region. Triangle Community Foundation is responsible for scholarship administration and independent evaluation of scholarship candidates, and the McClay Foundation, which wholly owns the Almac Group, is the sole financier of the Fund and its subsequent awards, including this year’s award.

Commented Julia Da Silva, Scholarships Officer at Triangle Community Foundation, “We’re thrilled to be able to partner with Almac Group to support Khadeeja through her college journey and see her join our community of scholars. We can’t wait to see the positive impact she will have on her community and the amazing things she will do with the degree she has chosen to pursue.”

The McClay Foundation was established by the late Sir Allen McClay, one of Northern Ireland’s most distinguished entrepreneurs and philanthropists and founder of Almac Group, with the vision to “make a meaningful improvement and advance human health,” through the contributions of Almac Group’s innovative family of companies and support to a wide range of global charitable organizations.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

About Triangle Community Foundation

Triangle Community Foundation is building a brighter future for everyone in the Triangle region of North Carolina. By working with dedicated donors and strong nonprofits, we are able to guide gifts in a strategic way to fill in gaps, reduce inequities, and solve the region’s most pressing challenges. Since 1983, we have envisioned a Triangle that works together so everyone can thrive. Learn more and join us at trianglecf.org.

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Almac Group and PILA PHARMA Ink Manufacturing Agreement

allie — Tue, 10 Aug 2021 07:00:00 +0000

Availability of API is a key factor in progressing ongoing type 2 diabetes clinical studies

Craigvon, U.K.- 10 August 2021- – Almac Sciences, global provider of integrated drug development services and member of the Almac Group, is delighted to announce that the company has signed a manufacturing agreement with Swedish biotech company, PILA PHARMA, for the production of XEN-D0501 active pharmaceutical ingredient (API).

From its global headquarter facilities in Northern Ireland, Almac Sciences will manufacture XEN-D0501, a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has demonstrated applications across pain and inflammatory diseases and possibly in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, and subsequently, PILA PHARMA has demonstrated good safety results as well as efficacy, i.e. a statistically improved endogenous insulin response to oral glucose versus placebo in patients with type 2 diabetes, thus demonstrating proof of principle of XEN-D0501.

Commented by Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company, “Almac Sciences is delighted to be working with PILA PHARMA and supporting their API manufacture. The project showcases deployment of our technology platforms including integration of green chemistries and we look forward to further opportunities in this space.”

Dorte X. Gram, CEO, PILA PHARMA states, “The availability of new API is key for us to be able to conduct planned 3-month toxicology studies, that are in turn a prerequisite for initiating our main goal, conducting a clinical phase 2b study with XEN-D0501 in type-2 diabetics. I am, therefore, very pleased to have signed off this agreement and we look forward to the collaboration with Almac on timely delivery of new API.”

The global company has proven expertise in small and large molecule analytics, API supply, stable & 14C radiolabelling, formulation development & solid-state services and earlier this year announced the completion of its £5 million two-storey centre for biocatalysis, flow chemistry technologies and peptide research and development.

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Almac Clinical Technologies and THREAD Partner to Eliminate Common Clinical Trial Delays

allie — Wed, 28 Jul 2021 12:00:00 +0000

SOUDERTON, PA, and CARY, NC- 28 July 2021– Almac Clinical Technologies, a member of the contract and development organization, Almac Group, and THREAD, a technology and service provider enabling decentralized clinical trials (DCTs), and today announced a strategic partnership. The market leaders will integrate their technologies to enable more efficient clinical trials that generate better outcomes.

By integrating their proprietary technology platforms, Almac and THREAD will provide sponsors and contract research organizations (CROs) with a full range of tools to reduce the risk of trial delays. Almac’s IXRS™ solution and industry-leading services for randomization and clinical trial supply management will be available to THREAD customers and THREAD’s DCT solution will be available to Almac customers. The two companies will leverage single sign-on and application program interfaces (APIs) to integrate their technologies and automate DCT workflows across their respective platforms to:

• minimize duplicate data entry, particularly for research sites
• provide sponsors with integrated reports on trial progress
• preserve automation to ensure operational efficiency

Organizations interested in learning more can request more information here.

“We’re thrilled to be working with THREAD, an acknowledged leader in DCT technology,” said George Tiger, vice president of Global Business Development, Almac Clinical Technologies. “As part of our growing Partnership and Alliance program, this specific partnership will enable us to offer an additional level of support to Almac clients as they seek to decentralize their clinical trials.”

“A common pain point for research sites is the abundance of technologies they have to independently maintain for each clinical trial,” said John Reites, chief executive officer of THREAD. “By integrating Almac within our comprehensive platform, sites and study teams will have a single DCT study experience. Almac is a longstanding global leader in clinical research, and we’re excited about this synergistic partnership.”

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Galen Medical Nutrition Announces Scholarship Award

davidkane — Tue, 27 Jul 2021 07:00:00 +0000

Supporting patients with metabolic disorders accessing further education

Craigavon, U.K. – 27 Jul 2021 – Galen, the privately-owned pharmaceutical sales and marketing company, is pleased to announce the inaugural Galen Medical Nutrition Scholarship Award designed to support people with metabolic disorders, such as Phenylketonuria (PKU), accessing further education, training and development courses or apprenticeships.

Entrants are required to complete an application form and submit a personal statement (1000 words or less) describing their educational plans and how this scholarship will enable them to achieve their personal and career goals. Two scholarships will be awarded to people with metabolic disorders and the award is open to applicants right across Europe.

The prize-winners will each win a bursary of up to £2,000/€2,500 towards their education/training course fees, in addition to a full technology package worth £2,000 including a state-of-the-art laptop, monitor, tablet, Apple watch and AirPods and a £200 voucher for study aids. Due to restrictions imposed as a result of COVID-19, the 2021 awards will be presented to the recipient at ceremonies in September.

The Galen Medical Nutrition Awards committee, which will include representatives from the metabolic disease community, will evaluate entries and select two winners based on their written entry, aspirations and commitment to study.

Dr Dennise Broderick, Managing Director & President, Galen, said: “We recognise that people who are born with metabolic disorders, such as PKU, and receive the correct treatment can absolutely have the same educational and career goals as anyone else. Galen is committed to bringing innovation, quality and customer focus to people diagnosed with this condition and we are delighted to launch this scholarship programme to offer support and encourage the aspirations of individuals who deserve the opportunity to fulfil their ambition.

She continued: “We look forward to awarding this year’s winners and following how they progress over the course of their studies and beyond.”

Submissions must be made using the Galen Medical Nutrition Scholarship Award Entry Form – www.galen-pharma.com/galen-medical-nutrition-scholarship and submitted via email to medicalnutritionaward@galen-pharma.com by 1700hrs (BST) on Friday 03 September 2021.

#END#

Notes to editors

About Galen

As a subsidiary of Galen Limited, Galen US also has a growing presence in select conditions such as those requiring topical anaesthesia. The company plans to continue expanding its portfolio with selected speciality products on an international basis. By combining innovation in product development with competitive pricing, Galen aims to work in partnership with healthcare professionals and patients to create real, long-term value.

For further information please visit: www.galen-pharma.com

About Almac Group

The international company is a privately owned organisation that has grown organically over the past five decades and now employs over 6,000 highly skilled personnel across 18 facilities globally.

For further information please visit almacgroup.com.

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Almac Group Announces Innovative Community-Based Partnership with Indian Valley Education Foundation

allie — Wed, 14 Jul 2021 11:00:00 +0000

Sponsorship will support a student experience project at Souderton Area High School

Souderton, PA – 14 July 2021 – Almac Group , the global contract development and manufacturing organization, is delighted to support an innovative student experience project at Souderton Area High School, in partnership with the Indian Valley Educational Foundation.

Understanding that today’s successful student experience requires access to collaborative space, technology, and a tangible connection between classwork and future opportunity, the project will support the remodeling of a large area of the Souderton Area High School library into a “Career & Collaboration Corner,” designed with students’ needs in mind. Through Almac’s financial support, the space will be outfitted with new furnishings and technology to foster collaboration, small group opportunities, and speakers, while also exposing students to Almac as a leading employer in the Indian Valley area.

The Group employs over 6,000 highly skilled personnel globally, 1,500 of whom are based across 3 locations in Pennsylvania. Almac provides a range of innovative services to the pharmaceutical and biotech industry, thereby offering a wide variety of career opportunities. Recently, the Indian Valley Chamber of Commerce recognized Almac with the “Pillar of the Community” award for exceptional contributions to combatting the COVID-19 pandemic, which included support to over 140 vaccine trials and treatment options.

Commented Alan Armstrong, Almac Group CEO, “At Almac, we are committed to inspiring and investing in the next generation of scientists, engineers and technologists who will continue our mission to advance human health. We are delighted that Souderton Area High School’s goal to expand and adapt the library into an innovative space for students is achievable with our sponsorship. We also wish to thank the Indian Valley Education Foundation for making it possible for us to support the students in our community.”

Commented Frank T. Gallagher, Ed.D., Superintendent of Schools, “The collaboration between community-based businesses with the Souderton Area School District through a partnership with the Indian Valley Education Foundation has been an incredible benefit to our students. I am grateful for Almac Group’s commitment to this community, and our students. By providing the resources to create this space they have provided a glimpse of what career education and development can and should be.”

Commented Sam Varano, Ed.D., Principal Souderton Area High School “We are incredibly grateful to Almac for providing a foundation for endless opportunities to connect our students’ classroom experiences to the “real world.”

A ribbon cutting ceremony, which will include representatives from Almac, Indian Valley Education Foundation, Souderton Area High School and invited members of the community, will be planned in the future to mark the project’s completion in school year 2021-2022.

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Almac Group’s Charnwood Site Achieves Globally Recognised Health & Safety and Environmental Management System Certifications

allie — Tue, 06 Jul 2021 06:55:00 +0000

Craigavon, UK, 6 July 2021 – Almac Group, the contract development and manufacturing organisation, is pleased to announce that the organisation’s Charnwood site (Loughborough, England) has been certified to the International Organisation for Standardization (ISO) standards 45001 and 14001, following a United Kingdom Accreditation Service (UKAS) accredited audit of the site’s Integrated Management System (IMS).

ISO is an independent, non-governmental, international organisation that produces international standards to support innovation and provide solutions to global challenges. Almac’s recent UKAS certifications in Charnwood were to ISO 45001 and 14001, globally recognised standards for Operational Health & Safety and Environmental Management, respectively.

Almac expanded to the Charnwood site in Loughborough in 2015, in direct response to client demand. The site is a complement to the company’s existing pharmaceutical drug product development services at the company’s global headquarter campus in Craigavon, Northern Ireland, which has been certified with Health & Safety and Environmental standards for over a decade. The facilities at Charnwood have significant capacity to support tailored GMP formulation development and manufacturing of solid oral dosage forms for clinical and small-scale commercial needs, in addition to housing over 1,500m² of readily available, customisable GMP floor space.

James Hurst, VP Operations & Charnwood Site Head, commented: “As an organisation, Almac takes our commitment to corporate social responsibility seriously. We are therefore delighted that the results of the UKAS audit certify that we meet the high ISO standard of Health & Safety and Environmental Management, a significant achievement in demonstrating that our Charnwood site is a safe, sustainable and responsible place for our global partners to conduct their projects. We look forward to further growth at the site.”

The integrated framework gives all managers and employees guidance and support regarding the management of HSE, from identifying and handling risks to evaluating and continuously improving processes and is continually updated and improved through regular assessments, reviews and internal audits. The certification of the Charnwood campus marks the start of Almac’s overall strategy to roll out the ISO 45001 and ISO 14001 certification throughout multiple sites across the globe in the coming years.

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Almac Group’s Ciara Cassidy Scoops ‘Developer of the Year’ at Digital DNA Awards

davidkane — Fri, 02 Jul 2021 10:50:20 +0000

Annual programme recognises, celebrates, and promotes Northern Ireland’s best tech talent

Craigavon, Northern Ireland – 2 July 2021 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is delighted to announce that Ciara Cassidy, Principal Applications Developer, was awarded ‘Developer of the Year’ at this year’s Digital DNA Awards, live-streamed from Belfast.

Now in their 6th year, the Digital DNA Awards are widely regarded as the number one awards programme for companies and individuals working within the fast growing and highly competitive tech industry in Northern Ireland.

Ciara Cassidy was named ‘Developer of the Year’ for her role as Lead Developer in Almac’s first foray into serverless application development, through a partnership with Amazon Web Services. Ciara’s team worked to architect and ramp up AWS to meet the needs of a business critical project, and after only 3 months of development, the solution went into production and is now actively used by a large Almac team.

Commented Brendan Woods, Group Head of Systems Delivery, “Almac’s Information Services team is a global and disparate central unit that supports mission critical life sciences applications 24/7. We are delighted to have a ‘Developer of the Year’ within our IS organisation, and congratulate Ciara on her well-deserved success.”

Commented Mark McColgan, Group Head of Software Engineering, “Since joining Almac in 2018, Ciara has become an integral part of our IS organisation. She expertly bridges the gap between pharma regulations, business applications, and the latest technologies to drive modernisation in our organisation, all while effectively mentoring other team members. She is very deserving of the ‘Developer of the Year’ award and I am thrilled to congratulate her success.”

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Almac Group Invests £600,000 to Expand Crystallisation Capabilities

allie — Thu, 01 Jul 2021 06:55:00 +0000

Craigavon, Northern Ireland – 1 July 2021 – Almac Sciences, a member of the Almac Group, has invested ~£350,000 in an automated crystallisation platform to support solid form screening of polymorphs, salts and crystals in addition to crystallisation of amorphous materials. A new Empyrean X-ray powder diffractometer, which allows X-ray powder diffraction analysis of samples, represents a further £250,000 investment by the company.

The ChemSpeed Swing Crystal platform automates many common crystallisation operations, which reduces overall duration for solid form screening projects, accommodates a 24/7 run schedule and allows for rapid screening of a significantly wide variety of crystallisation conditions, including where limited sample quantity is available. The platform has the capability to:

Weigh up to eight different powdered solids from 1mg- 100g, including either amorphous or crystalline material and electrostatic powders
Handle up to 60 different liquids, including a range of organic solvents, acid and base solutions for volumetric dispensing from 100µL-10mL
Dispense into glass vials or well-plates suitable for direct analysis by X-ray powder diffraction
Filter slurries and provide inert atmosphere options for sensitive materials, where required
Carry out a diverse range of crystallisation unit operations, including evaporation, slurry, temperature cycling, and antisolvent additions, thereby maximising the chance of nucleation / crystallization of the material

The platform is currently set up to accommodate vials and has been selected due to its ability to be adapted, allowing the ability to facilitate well-plates in future.

Dr Jonathan Loughrey, Physical Sciences Manager, Almac Sciences, commented: “We are excited to remain at the forefront of solid form research and development by embracing automation to maximise experimental diversity and sample throughput for tailored work programs to ensure our clients receive a premier service offering.”

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company, commented: “Almac Sciences is a cutting-edge science and technology partner and we are committed to investing in the latest equipment to best serve our clients. With the time and cost saving benefits of automation in mind, we’re delighted to announce this further investment into automating our crystallisation capabilities which is modular in design enabling elements to be upgraded in the future for expanded use cases.”

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Almac Pharma Services Launches Trainee Recruitment Drive

kelly — Wed, 16 Jun 2021 14:24:49 +0000

Craigavon, UK, 16 Jun 2021 – Almac Pharma Services, a member of established global contract development and manufacturing organisation Almac Group, is recruiting up to ten new Trainee roles within its Packaging Operations team at the company’s global headquarters in Craigavon.

The new Trainee Production Operative roles will be 1-year fixed term contracts with potential to become permanent members of the Almac team and progress towards Grade 2 Senior Operator status. Beyond this, opportunities exist to progress to Grade 3 Senior Operator, Production Technician and Supervisor roles.

There is further potential to transfer skills and explore other support roles within Almac Pharma Services, for example in Quality, Validation or Production Support.

The roles in question are suitable to those who are qualified to A-Level (or an equivalent level 3 standard qualification), including those expecting to receive grades in August. The company is particularly interested to hear from candidates who have studied Life and Health Sciences (or other STEM subjects) and BTEC Applied Science. Candidates who are mechanically minded or are proficient in the use of computer software and touchscreen applications will also be of interest.

Mentorship and full training will be provided by Senior Operators and the Operations Management team. Successful candidates will be guided to find aspects of the role where their unique skills can be put to use, enhancing their capabilities and assisting them to truly shine in their career.

With over 30 years’ experience in the development and manufacture of medicinal products, the capabilities of Almac Pharma Services include formulation and analytical development, clinical and commercial-scale drug product manufacture, primary and secondary packaging and global supply chain management.

Mark English, VP Packaging & Logistics at Almac Pharma Services, said, “The Institute for Fiscal Studies reported that young workers today would be hit hardest by the pandemic with regards to unemployment and job prospects. We are pleased, particularly in the current climate, to be recruiting for STEM roles that would be suited to school leavers or young adults who are qualified with relevant A-Levels or BTECs.

“At Almac, we are passionate about mentoring our junior employees to highlight the possibilities that come with their skillset and developing those skills to unlock potential progression and growth. We look forward to welcoming our new colleagues to help us advance human health together.”

For information on the opportunities available, including job specification and to make an application ahead of the deadline on 9 July, please visit Almac Group Careers website.

ENDS

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com

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Almac Group Launches Innovative Virtual Work Experience Hub

laurenharris — Mon, 14 Jun 2021 07:00:00 +0000

Craigavon, Northern Ireland – 14 Jun 2021 – Almac Group has launched a new, first of its kind virtual work experience programme enabling young people to gain a real insight into life at one of world’s top global contract pharmaceutical development and manufacturing organisations.

With in-person shadowing and visit opportunities halted due to the Coronavirus pandemic, Almac has pivoted its traditional in-person work experience programmes to offer a fully virtual learning experience and fulfil its commitment to continue to invest in young people.

The newly launched Almac Virtual Work Experience Hub allows students to discover the wide variety of career paths available at Almac through a series of day-in-the-life videos, presentations, activities and Q&A sessions with Almac professionals.

Aimed at students aged 15 to 18 (academic years 12-14) right across Northern Ireland, the programme is flexible and learner-driven, meaning individuals can select relevant content to complete entirely at their own pace and can also receive a Certificate of Completion.

Placement numbers are unlimited and students can log on from any location which provides even greater access to the programme which would traditionally be held in-person at the company’s global headquarter site in Craigavon.

Dr Frances Weldon, Almac Group’s STEM Outreach Manager said: “Investing in the potential of Northern Ireland’s young people is of the utmost importance to Almac Group, demonstrated through our many established outreach programmes. Whilst COVID-19 posed many challenges, it was essential that we pivot to continue to meet the needs of students. Our accessible, enriching virtual hub equips students with unique career exploration resources, while also building digital literacy and critical thinking skills. We are thrilled to be able to offer this innovative programme and look forward to welcoming more students as it continues to progress.”

Dr Megan Smyth conducted work experience at Almac as a student and is now employed as a Technical Leader at Almac Sciences. She commented: “The biggest influence on my career came on the first day of Upper Sixth when I visited Almac. I only had to spend a few hours in the labs in Craigavon to cement in my mind that this was the role for me. The people that I met were passionate and inspired me to pursue a career in Science. The continued support and mentorship I received from Almac during my University studies shaped my career direction. I have never looked back and feel very fortunate to have found a career path that is rewarding, stimulating and that I still get that buzz about the potential opportunities to come. I would highly recommend the Almac programme, and now it’s virtual it can offer participants so much more, including the opportunity to be part of a truly global team!”.

To find out more and participate in our virtual work experience programme, click here: https://www.almacgroup.com/careers/almac-work-experience-hub/

#ENDS#

About Almac Group

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Almac Group’s Turnover Increases by £43M to £677M in 2020

allie — Mon, 07 Jun 2021 13:55:40 +0000

6% growth in global workforce to 5,466 during same period

Craigavon, N.I., 07 Jun 2021 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has reported a £43 million (6%) rise in turnover from £634.3 million in 2018/19 to £677.3 million for its financial year 2019/20.

During this period, the revenue increase resulted in improved pre-tax profits which were recorded at £63.5 million, up from £47.6 million for the same period the previous year. Group performance in 2020 was enhanced through the receipt of a number of out-licencing payments from products developed in-house.

Average employee figures increased from 5,150 to 5,466 during the same period. These figures were recorded in the organisation’s annual report for year ending 30 September 2020.

Throughout this year, Almac invested significantly in both new and existing facilities to meet ongoing global demand for its unique, high-quality solutions. In addition, the Group completed the acquisition of Swedish-based boutique healthcare company, POA Pharma, which added substantial new therapeutic areas and territories to its existing Galen portfolio.

As the race for a vaccine and treatment for COVID-19 escalated, Almac partnered with a variety of global pharmaceutical, biotech and research institutions to support over 140 separate crucial research projects through a range of service areas, including analytical services, peptide development, expedited Interactive Response Technology (IRT) support and clinical trial management.

Alan Armstrong, Almac Group CEO, commented: “The last financial year was challenging for everyone as companies, including Almac, had to adapt much of their typical operational practices in response to the pandemic whilst ensuring the safest working environment for employees. I am extremely proud of Almac’s efforts to ensure client service levels were not impacted in any way throughout and ensuring patients received the medication they so depend upon. The commitment, dedication and professionalism from our employees has been exemplary and I wish to thank them all.

He continued: “Almac’s mission is to “advance human health” and this has never been more applicable than right now as we continue to support multiple companies in their quest to make significant advances in the fight against COVID and other diseases. With 100% of our profits reinvested into our business, we have already committed to a number of significant expansion and improvement projects across our sites in the US, Europe and Asia in order to ensure we provide the premium solutions our global client base rely on.”

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Almac Group Named 2020 “Pillar of the Community” by Indian Valley Chamber of Commerce

allie — Fri, 04 Jun 2021 00:02:49 +0000

Souderton, P.A. – 3 June 2021 – Almac Group, the global contract development and manufacturing organization, is delighted to announce that the organization was named the 2020 “Pillar of the Community” by the Indian Valley Chamber of Commerce. The award was presented at the Chamber’s annual awards dinner, held this year on June 1 in Telford.

The Pillar of the Community is awarded annually to a large business, actively involved in the Chamber that has demonstrated a significant commitment to the community by the company and its employees. Nominations are submitted by a Chamber Executive Committee, and the final decision to award Almac was made by the Chamber’s Board of Directors.

Almac was named this year’s Pillar of the Community due to the exceptional contributions of Almac and its employees during the COVID-19 pandemic. As an essential business, Almac continued its operations through the pandemic, ensuring no interruption in the supply chain of the hundreds of essential medicines the company supports through its integrated range of services across the drug development lifecycle. In addition, Almac contributed to over 140 treatment and vaccine options to combat COVID-19, notably supporting the Pfizer-BioNTech vaccine clinical trial, which upon authorization, has led to millions of vaccinations across the globe and a distinct turning point in the pandemic.

Mark Rohlfing, VP of Operations, Almac Clinical Services, accepted the award with remarks on behalf of Almac. He commented: “Almac’s mission is to advance human health, and we believe this extends to supporting the health and well-being of our local communities. Therefore, we are proud to support the Indian Valley community and Chamber of Commerce.”

“We’re also proud to acknowledge that with this award, the Chamber has recognized the exceptional dedication of hundreds of Almac employees in Pennsylvania, whose contributions directly supported COVID-19 relief efforts, as well as the continued supply of hundreds of other essential medications for patients across the globe. Our people are essential to our success and we are grateful to the Chamber for acknowledging the impact of their hard work during unprecedented times.”

Steven Hunsberger, Executive Director at Indian Valley Chamber of Commerce, commented: “We are thrilled to recognize Almac as the Indian Valley Chamber of Commerce’s 2020 Pillar of the Community. Through their contributions to human health and most recently, the COVID-19 pandemic, Almac has the distinction of providing significant service to not just our community, but the world. We are proud to watch them thrive in the Indian Valley and look forward to a continued prosperous future together.”

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Almac Group Announces Expansion into North West

kelly — Wed, 02 Jun 2021 12:48:58 +0000

Creation of up to 100 new career opportunities in next three years

Craigavon, UK, 02 Jun 2021 – Almac Group, the global contract development and manufacturing organisation, has today announced the launch of a recruitment campaign with a view to setting up a facility in Derry/Londonderry.

With over 5,600 employees located in 18 locations across the world, 3,600 of whom are based at its global Headquarter campus in Craigavon, Almac is planning to offer up to 100 new, highly skilled jobs specifically targeting the North West region of Northern Ireland over the next three years. The initial recruitment drive is underway and offers a mixture of project management and software engineering positions at all levels. Experience of the pharmaceutical industry is not an essential requirement for these roles as full on-the-job training is provided.

Alan Armstrong, CEO, Almac Group, explains, “We are experiencing significant growth and have a need to support our many clients across the globe. With substantial advancement in technology, we are fortunate to be able to locate our employees anywhere we choose offering greater flexibility and access to our various range of services. Given the skills pipeline coming from Ulster University at Magee and Coleraine, combined with the excellent choice of workspace available in the Derry/Londonderry area, we have decided to explore this region as our next Almac location.

“We are proud to have our global Headquarters based in Northern Ireland and it is our plan to expand our reach and establish a base in the North West. We are hopeful that, when word spreads about our expansion plans to this region, we will be able to obtain the required numbers and quality of job applicants who are keen to join us and support our mission to advance human health globally.

“Given the success experienced by many other companies in this area, we plan to employ up to 100 staff at this new location over the next three years.”

This announcement comes as the company continues to recruit globally, in particular for its Craigavon campus, as the company grows in response to increased client demand.

To find out more or to apply for a position, visit: https://hubs.li/H0Pqy0-0

ENDS

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Almac Group invests £325,000 as part of Stage 1 entry into continuous flow manufacturing

allie — Tue, 25 May 2021 06:00:00 +0000

Enabling seamless “flow” for our clients through proof-of-concept, scale-up and manufacture

Craigavon, Northern Ireland – 25 May 2021 – Almac Sciences, a member of the Almac Group, has invested £325,000 in continuous flow chemistry equipment to further its most recent laboratory expansion, a £5 million, two-storey R&D centre for flow chemistry, biocatalysis and peptide technologies.

Sited within a dedicated laboratory in the new 32 fumehood technology centre, Almac Sciences’ 10-strong custom and flow chemistry team, can rapidly screen new processes to demonstrate reaction validity under continuous flow and the added value of technology implementation for clients. Success affords the opportunity to move immediately to kilo scale and subsequent delivery of product with seamless “flow”.

Dr. Scott Wharry, Almac Sciences’ Custom and Flow Chemistry Manager commented: “The recent investment is critical for our strategic growth and highlights Almac Sciences’ commitment to offering our clients the best available technology solutions. Our technology development has included the installation and commissioning of high pressure hydrogenation pilot rig (with capability range up to 300◦C and 100 Bar pressure) and from Chemtrix both lab (Labtrix^® ) and kilo (Protrix^®)scale flow rigs. These enhanced capabilities enable us to deliver superior solutions driving projects from proof of concept to kilo manufacture rapidly in response to our customers’ critical timelines”.

Additional flow equipment within the facility includes: microreactors, photocatalysis flow rig, Continuous Stirred-Tank Reactors (CSTR’s), Vapourtec E series flow rig, in-house built cryogenic rigs, microbubble and pressure technology, as well as, spray drying, UF/DF and liquid-liquid separation technology.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company commented: “This investment highlights our commitment to ensure continual innovation and world-class technology platforms to meet the increasing demand of our global clients across the pharmaceutical, biotechnology, life sciences and fine chemicals sectors. This, coupled with our established expertise demonstrates our long-term commitment to advancing our capability and innovative range of services for our clients.”

Almac Sciences has seen rapid growth over the last five years and an anticipated continued trajectory with significant investments in its global non-GMP and GMP manufacturing plants, in addition to enhanced analytical solutions to support increased client manufacturing demands. Further announcements are expected in the coming months.

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Almac Group Launches Partnership with Philadelphia Education Fund

allie — Thu, 15 Apr 2021 07:00:29 +0000

Almac Group Scholarship aims to promote opportunity and remove the financial barriers to undergraduate study

Souderton, PA – 15 April 2021 – Almac Group has today announced the establishment of the Almac Group Scholarship, in partnership with the Philadelphia Education Fund (PEF ). The inaugural award, renewable up to $75,000 over four years, will be made to a sole recipient in Summer 2021.

The Almac Group Scholarship is a needs-based award, open to graduates of the Philadelphia Education Fund’s College Access Program who seek to attend an accredited college or university located in Pennsylvania. The College Access Program is a comprehensive college readiness program for 9th through 12th graders in Philadelphia’s lowest graduation-rate high schools, designed to help low-income, students of color, and first generation college-goers reach their educational ambitions through one-on-one advising, college readiness workshops, financial aid counseling, and access to private scholarships.

In addition to financial assistance, the selected student will participate in PEF’s Philadelphia Scholars Program to ensure a successful undergraduate experience. The student will have the opportunity to develop a meaningful relationship with Souderton-based pharmaceutical contract development and manufacturing organization, Almac Group, gaining unique exposure to the vast range of careers available in the global pharmaceutical and biotech industry.

Support for the Almac Group Scholarship comes directly from the McClay Foundation, the sole shareholder of Almac Group. The Foundation was established by the late Sir Allen McClay, one of Northern Ireland’s most distinguished entrepreneurs and philanthropists and founder of Almac Group, with the vision to “make a meaningful improvement and advance human health,” through the contributions of Almac Group’s innovative family of companies and support to a wide range of global charitable organizations.

“Recognizing the significant barriers to education that many students face, we are honored to launch the Almac Group Scholarship, specifically designed to support local students in their educational ambitions, regardless of financial circumstance,” commented Alan Armstrong, CEO of Almac Group and Chairman of the McClay Foundation. “We are delighted that in Philadelphia Education Fund, we have successfully identified a charitable partner which shares in one of our core values —that educational opportunity has the power to transform lives and communities. We look forward, with great anticipation, to awarding to a deserving student this summer.”

“We are grateful to Almac Group and McClay Foundation for their recognition of our work, and we’re excited to be able to offer this scholarship to our students,” said Farah Jimenez, PEF’s President and CEO. “What makes this new partnership special is the career exposure opportunity that the student will have. Having a broader sense of where their degree can take them will be both guiding and motivating.”

The Almac Group Scholarship in Philadelphia is one of two programs launched in 2021 with support from McClay Foundation to support local students in the communities that Almac Group calls home. Local to our Durham facility, a partnership was launched with Triangle Community Foundation, paving way for a student in the North Carolina Triangle region to be awarded a scholarship in Summer 2021 as well.

Locally, McClay Foundation has continued to support Children’s Hospital of Philadelphia, most recently by assisting the scale-up of support to children treated at CHOP’s “Community Health and Literacy Center” located in South Philadelphia. In addition, recognizing that charitable organizations had been impacted significantly as a result of the pandemic, Almac announced late last year that it had donated a quarter of a million pounds to 33 charities globally in order to support their critical work. In the Philadelphia metro area, those beneficiaries included CHOP’s COVID Relief Research & Development Fund, and Laurel House, a comprehensive domestic violence agency serving families in Montgomery County.

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Almac Group Appoints Julie Shannon as Vice President and Deputy Head of Information Services

allie — Wed, 14 Apr 2021 06:30:00 +0000

Craigavon, UK, 01 April 2021 – Almac Group, the contract development and manufacturing organisation, has today announced the appointment of Julie Shannon as Vice President and Deputy Head of Information Services (IS), globally.

In her role as VP, Julie will continue to support the Group’s Global Vice President & Group Head of Information Services, Andy Hillis. She will oversee the continuous streamlining, simplification and improvement of processes, with a view to removing non-value adding tasks thereby improving delivery across the entire department.

Julie will also be introducing the concept of shared services into IS in an effort to increase and improve collaboration in the standardization of service delivery provided by the department. This will ensure the IT operating model provides the best value to Almac by understanding current and future technology needs.

Improving the management of the Group’s IS suppliers and vendors will also be a key part of Julie’s role as they, in many cases, provide key technical expertise which in turn supports the services provide by the team. She will also provide executive-level leadership and guidance to Almac’s IS operations which provides support for over 4,000 global users.

Having spent time working for multinational information technology equipment and services company, Fujitsu, Julie joined the Almac IS team in 2001 and has been a key member throughout. Most recently she served as Group IS Support Manager where she led a global team to support Almac’s IS infrastructure, network, databases, systems and hardware.

Providing an extensive range of integrated services to the pharmaceutical and biotech sectors globally is built upon sound IS infrastructure and as Almac Group has grown, so too has the Group’s dependency on more advanced, secure and innovative digital technology. With over 2 decades experience, Julie has played a pivotal role in the seamless execution and expansion of IS services and support across Almac’s multiple facilities and offices throughout Europe, Asia and the United States in order to meet this growing demand.

Andy Hillis commented on Julie’s appointment: “I am delighted to announce Julie’s promotion to Vice President and Deputy Head of Information Services. Over the past 20 years she has been a valuable member of our team providing advice, guidance and support to enable the continual development of our global IS infrastructure, operations and resources. The commitment, experience and expertise Julie has demonstrated through her various roles within the department has been crucial in supporting the development of the IS team and I wish her every success in her new role.”

ENDS

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Almac Group Awarded ISO Certification for Integrated Safety and Environment Management System

kelly — Thu, 25 Mar 2021 07:00:00 +0000

Craigavon, Northern Ireland – 24 Mar 2021 – Almac Group, the global contract development and manufacturing organisation, has recently secured the International Standard Organization (ISO) certifications for its Integrated Health, Safety and Environment Management Systems under the ISO 45001 and ISO 14001 standards – the most internationally recognised standards for health, safety and environment (HSE) management systems.

The achievement followed an extensive virtual auditing process, performed by the National Quality Assurance (NQA) certification body over a three-day period. The audit involved a range of virtual tours, presentations and an extensive review of Almac’s integrated management system. NQA determined that Almac demonstrated a clear commitment to meeting the highest standards of HSE and accountability throughout the business and are fully accountable for ensuring these standards are maintained through integrated and standardised policies and procedures.

The certification covers Almac Group’s provision of research, development, innovation and contract manufacturing services by each of its facilities based at its global Headquarters campus in Northern Ireland, which employs over 3,500 individuals. The integrated framework gives all managers and employees guidance and support regarding the management of HSE, from identifying and handling risks to evaluating and continuously improving processes and is continually updated and improved through regular assessments, reviews and internal audits.

Jon Cooil, Global VP HSE, Facilities and Engineering, Almac Group commented: “This ISO certification is an acknowledgement that our robust processes, procedures and systems have been designed and implemented with health, safety and the environment as the utmost priority.

We consistently adhere to the highest standards and guidelines enabling us to have an organised and streamlined set of processes that perform seamlessly and efficiently, whist providing a healthy and safe working environment for our employees. The achievement underpins our ongoing commitment to provide world-class contract manufacturing and development solutions to our global clients.”

The Group’s HSE team is currently progressing the programme to extend the scope of both ISO 45001 and ISO 14001 to several of its European sites.

#ENDS#

About Almac Group

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Almac Group Announces Four-Year PhD Scholarship at UCL

kelly — Mon, 08 Mar 2021 08:00:00 +0000

Unique academic /industry collaboration supports discovery of novel enzymatic alkylation technology

Craigavon, Northern Ireland – 08 Mar 2021 – Almac Sciences, a member of the Almac Group, has announced its collaboration with University College London (UCL) aimed at investigating the use of enzymes for selective alkylation.

The exclusive programme builds on their strong relationship, first announced in 2013, and will see Almac co-fund a BBSRC London Interdisciplinary Biosciences PhD Consortium (LIDo) iCASE PhD scholarship over the next four years to investigate selective alkylations using enzymes.

Alkyl groups can have a significant beneficial effect on the physicochemical and biological properties of bioactive compounds. However, it is very difficult to achieve selective alkylation reactions using traditional synthetic approaches and toxic reagents are typically used. Enzymatic alkylation provides a highly valuable alternative method using a specific class of transferase enzymes. They are particularly useful enzymes for the regioselective alkylation of compounds as well as the diversification of compound libraries.

Almac is interested in developing the use of these transferase enzymes in selective alkylation reactions with the aim of constructing novel enzyme cascades for the sustainable synthesis of structurally diverse compounds.

Lead academic at UCL, Prof. Helen Hailes says ‘We are very excited to continue to work with Almac Sciences on the discovery and application of transferase enzymes for the selective derivatisation of pharmaceutically relevant compounds and for incorporation into enzyme cascades.”

This latest development demonstrates Almac’s ongoing commitment to innovation as it continues to engineer its technology platforms for the pharmaceutical, biotechnology, life sciences and fine chemicals sectors. This investment comes just weeks after the company announced it had completed a £5 million R&D centre within which its multi-million programme to accelerate enzyme discovery (INSIGHT^TM) is currently underway.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company commented: “We have a strong track record working with UCL that spans more than a decade and look forward to working with Helen, and her new PhD student, Matthew Salinger. I wish Matt every success in his studies and look forward to our first publication together as we welcome him to our new custom-built technology centre at our global headquarters.”

#ENDS#

About Almac Group

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Almac Clinical Technologies Appoints Abi Pesun as Vice President of UK Operations

kelly — Mon, 01 Mar 2021 08:00:00 +0000

Craigavon, UK, 01 March 2021 – Almac Clinical Technologies, a member of the Almac Group, today announced the appointment of Abi Pesun to the position of Vice President of UK Operations.

In her role as VP, Abi will oversee the organisation’s United Kingdom Operations and staff, provide strategic direction for regional projects, and serve as executive sponsor for key accounts. She will also continue to oversee the operational team supporting Almac ONE – a unified clinical trial solution that harnesses over three decades of experience delivering Clinical Supplies services and Interactive Response Technology to redefine the Clinical Supply Chain experience, creating a responsive end-to-end process that enhances visibility and accuracy throughout the lifecycle of a clinical study.

Prior to her role as Vice President, Abi most recently served as Director of Clinical Project Services. She has been a key member of Clinical Technologies for 20 years, and notably played a pivotal role in the incorporation and expansion of Almac Clinical Technologies into Almac Group’s Headquarters site in Craigavon, Northern Ireland.

Valarie Higgins, President and Managing Director of Almac Clinical Technologies, commented on Abi’s appointment: “We are pleased to congratulate Abi on her well-deserved promotion to our executive management team at Almac Clinical Technologies. She has made remarkable contributions to our clients and our organisation as she has progressed from Group Leader to Manager and then Director, most notably as a driving force behind our innovative unified clinical trial solution, Almac ONE, and for her leadership role in expanding our Craigavon office into the multi-site facility it is today. We look forward to seeing her unquestionable success in the future.”

ENDS

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Almac Group Completes £5million Research & Development Centre

kelly — Tue, 23 Feb 2021 07:00:00 +0000

Significant expansion of biocatalysis, flow chemistry, and peptide capacity

Craigavon, Northern Ireland – 23 February 2021 – Almac Sciences, a member of the Almac Group, has completed a £5 million investment in a new two-storey centre for biocatalysis, flow chemistry technologies and peptide research and development.

Almac Sciences has grown rapidly over the last 5 years with significant investments in its non-GMP and GMP manufacturing plants to support increased client manufacturing demands. Adding to this growth, the first phase of expansion for technology development has been completed with the opening of a new facility housing additional R&D scientists to develop new technology and projects for Almac’s established biocatalysis, flow chemistry and peptides businesses. Additional capacity has also been created to enable further growth of its chemical development offering.

The 2,000m², two-storey dedicated technology centre is located at the Group’s global headquarter campus and consists of 32 fume hoods, an engineering workshop for tooling and has capacity to accommodate up to 100 employees. Active recruitment for 20 additional staff members is underway and with a significant number of projects already commenced.

The completion of this new facility further showcases Almac’s dedication to innovation and investment in technology as it continues to engineer its technology platforms for the pharmaceutical, biotechnology, life sciences and fine chemicals sectors and comes just months after Almac announced its multi-million pound investment to further develop a program to establish IN Silico Informed metaGenomic Harvesting Technology (INSIGHT) continuing its commitment to develop flow processes.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company commented: “The investment in this new, state-of-the-art facility has been critical to support the rapid expansion of our innovative technology offering across different disciplines. As our technology evolves, we are experiencing an ever-increasing pipeline of projects taking advantage of our integrated offering from development through to manufacture. It is an exciting time to be at Almac as our technology success breeds success. We look forward to driving innovation for our clients in this new centre.”

The next phase of development is currently underway with further announcements expected in the coming months.

#ENDS#

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Almac Group Launches Scholarship Fund, Will Award $50,000 to Triangle Student in 2021

kelly — Wed, 27 Jan 2021 12:00:00 +0000

Fund aims to promote opportunity and remove the financial barriers to undergraduate study

Durham, North Carolina – 27 January 2021 –Almac Group has today announced the establishment of the Almac Scholarship Fund in partnership with Triangle Community Foundation. The inaugural award, a $50,000 over four-year scholarship, will be made to a sole recipient in Spring 2021.

The Almac Scholarship Fund of Triangle Community Foundation exists to support first-year college students in the Triangle region pursuing four-year degrees at a North Carolina public college or university. Applicants must be a resident of Chatham, Durham, Orange, or Wake county, and must demonstrate financial need.

In addition to tuition assistance, the selected student will receive resources from Triangle Community Foundation to help support a successful undergraduate experience and will have the opportunity to develop a meaningful relationship with Durham-based contract development and manufacturing organization, Almac Group, gaining exposure to the organization’s role in the global pharmaceutical and biotech industry.

Support for the Almac Scholarship Fund comes directly from the McClay Foundation, the sole shareholder of Almac Group. The Foundation was established by the late Sir Allen McClay, one of Northern Ireland’s most distinguished entrepreneurs and philanthropists and founder of Almac Group, with the vision to “make a meaningful improvement and advance human health,” through the contributions of Almac Group’s innovative family of companies and support to a wide range of global charitable organizations.

The application for this year’s Almac Scholarship Fund award is currently live and interested students must apply via Triangle Community Foundation’s online portal (link here) by noon on March 1.

“Recognizing the significant barriers to education that many students face, we are honored to launch the Almac Scholarship Fund, specifically designed to support local students in their educational ambitions, regardless of financial circumstance,” commented Alan Armstrong, CEO of Almac Group and Chairman of the McClay Foundation. “We are delighted that in Triangle Community Foundation, we have successfully identified a charitable partner which shares in one of our core values —that educational opportunity has the power to transform lives and communities. We look forward, with great anticipation, to making our first award to a deserving student this spring.”

“As an employer of approximately 400 individuals in the Triangle region, Almac, with the support of the McClay Foundation, has always endeavored to make a positive contribution to the community in which we all live and work,” commented Donna Christopher, Global VP of Operations, Almac Clinical Services. “With the average college debt sitting at over $25,000 per student in North Carolina, our scholarship award is poised to make a considerable, measurable impact on the life of a local student. On behalf of all my colleagues in Durham, we look forward to celebrating this year’s awardee in the spring, and chart their success in the future.”

“We’re excited to be partnering with Almac, an international business with a local presence, to offer such a significant scholarship to a Triangle student,” said Sarah Battersby, MSW, Senior Scholarships & Education Officer, Triangle Community Foundation. “In these challenging economic times, and with the added impact of the COVID-19 pandemic, we know that scholarships are more critical than ever in enabling our youth to attend and successfully complete college.”

Locally, over the past two years, the McClay Foundation has continued to support Duke Children’s Development Hospital programs for families in need. Most recently, this support has provided access to vital small items, such as thermometers for infants, diapers, infant, toddler and child car seats, transportation vouchers and health & hygiene packages for adolescents, to over 14,000 families in the region. In addition, recognising that charitable organisations had been impacted significantly as a result of the pandemic, Almac announced late last year that it had donated a quarter of a million pounds to 33 charities globally in order to support their critical work.

#ENDS#

About Almac Group

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Almac Group Further Expands Global Biologics Testing Solutions

kelly — Tue, 26 Jan 2021 07:00:00 +0000

£0.5M investment in mass spectrometry support accelerates biologics development and approval

Craigavon, Northern Ireland – 26 January 2021 – Almac Sciences, a member of the Almac Group, has announced additional expansion of its biologics testing laboratory with significant investment in mass spectrometry equipment.

The new high-resolution mass spectrometer has been installed at Almac’s global headquarters, located in Northern Ireland, and will support its biologics offering for the analysis of peptides, proteins, glycoproteins and antibody products. This adds to the existing industry support at its new biologic testing laboratory based in Athlone, Ireland, announced just three months ago, which supports QC release and characterisation of biologics.

The £500,000 investment in a Thermo Orbitrap LC-MS instrument substantially increases the company’s capabilities in solving biologic analytical challenges and underlines Almac’s commitment to providing the latest in cutting-edge analytical solutions, equipment and facilities for its global client base. The instrument is capable of offering a complete analysis package to cGMP including amino acid sequencing, peptide mapping, disulfide bridge analysis using MS and MS/MS, glycosylation analysis, identification of post-translational modifications e.g. acetylation, phosphorylation in addition to biomarker discovery.

With this additional service, clients will benefit from an extended range of mass spectrometry services including the quantitation of genotoxic impurities, structure elucidation, isotopic purity determinations and high-resolution mass spectrometry of both large and small molecules.

John Robson, VP Analytical Services, Almac Sciences commented, “This new mass spectrometer reinforces Almac’s vision of delivering the best for our customers and substantially enhances the level and depth of services we provide.”

John Malone, Analytical Manager added, “We are delighted with this vital investment – whilst customer focus is always our priority, we are confident that the enhanced service offering will benefit our clients further.”

The addition of this equipment further complements the well-established range of analytical services already offered from Almac’s global analytical testing facilities located in the UK, Ireland and North America.

#ENDS#

About Almac Group

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The College of Paramedics Opens Dr John Hinds Scholarship Call for Entries

evewallace — Mon, 25 Jan 2021 07:00:00 +0000

Craigavon, N.I., 25 January 2021 – The College of Paramedics, in association with Galen, the privately-owned pharmaceutical sales and marketing company is pleased to announce that applications for this year’s Dr John Hinds Scholarship Award will open on Tuesday 26^th January 2021. The recipient will win a place on the much-coveted Anaesthesia Trauma and Critical Care (ATACC) course and have their case study published in the College of Paramedics’ magazine, ‘Paramedic INSIGHT’.

Dr Dennise Broderick, Managing Director & President, Galen, said: “This award is not only a fitting and lasting tribute to Dr Hinds but it also provides a unique opportunity for healthcare professionals to advance their expertise and gain access to a highly coveted training programme. Dr Hinds was a pioneering leader in the field of emergency trauma care who dedicated his life to helping others and Galen is therefore proud to support this annual scholarship programme in his honour.”

Last year’s recipient, Orla Morrow of Northern Ireland Ambulance Service, Belfast commented: “The ATACC programme is accredited by the Royal College of Surgeons and is an extremely coveted course worldwide. It provides an opportunity to learn and experience, through simulation, the most up-to-date and advanced trauma skills within the pre-hospital environment and offers a range of examples of how to apply these in practice. I was delighted to win my scholarship and would like to thank both Almac and the Hinds family for providing this amazing opportunity.”

Submissions must be made using the Dr John Hinds Scholarship Award Entry Form – l in k and submitted via email to awards@collegeofparamedics.co.uk by 1200hrs on Friday 26 March 2021. The College Honours and Awards Committee will then select the winning piece. Due to restrictions imposed as result of COVID-19, the 2021 award will be presented to the recipient at a ceremony in September.

Submissions should be 750–1,000 words, excluding references and appendices. As a condition of the award, the recipient will be required to submit their case study

for publication in Paramedic INSIGHT magazine which has over 20,000 subscribers, along with a follow-up article that describes their experience on the ATACC course.

#END#

Notes to editors

About College of Paramedics

About Galen

As a subsidiary of Galen Limited, Galen US also has a growing presence in select conditions such as those requiring topical anaesthesia. The company plans to continue expanding its portfolio with selected specialty products on an international basis. By combining innovation in product development with competitive pricing, Galen aims to work in partnership with healthcare professionals and patients to create real, long-term value. Visit: www.galen-pharma.com

About Almac Group

The international company is a privately owned organisation that has grown organically over the past five decades and now employs over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

For further information please visit almacgroup.com.

About The ATACC Group

For further information please visit https://www.ataccgroup.com

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Personal Genome Diagnostics and Almac Diagnostic Services Enter Strategic Collaboration to Enhance Patient Care in Oncology

kelly — Mon, 11 Jan 2021 13:00:00 +0000

BALTIMORE, MD, January 11, 2020 – Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, announced today a strategic collaboration with Almac Diagnostic Services to enhance opportunities for clinical trial development and companion diagnostic (CDx) projects.

PGDx and Almac Diagnostic Services will focus on providing access to tumor profiling assays for both tissue and plasma samples, specifically, PGDx elio™ tissue complete and PGDx elio™ plasma resolve. This collaboration will combine Almac’s world-class genomics services and expertise in development and delivery of molecular diagnostics with PGDx’s leadership in cancer genomics to accelerate solutions that will deliver precision medicine to more patients.

“We are proud to enter into this strategic collaboration with Almac. Their longstanding reputation for providing high quality lab services to patients worldwide, along with their proven track record of implementing new technologies make this partnership ideal,” said Megan Bailey, CEO, PGDx. “As we continue our quest to empower the fight against cancer, collaborating with Almac will allow us to deliver precision medicine solutions to a broader population and advance innovations in next-generation sequencing technology.”

Michael Sloan, Global Vice President of Commercial Operations, Almac Diagnostic Services said: “This collaboration with PGDx will enable Almac to provide our Pharmaceutical and Biotech partners with tissue and liquid biopsy options to support their translational research, clinical trials and CDx development requirements. The assay panels PGDx have developed will allow our clients to access world-class next generation sequencing science and bioinformatics solutions.”

About Personal Genome Diagnostics

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by researchers from Johns Hopkins University who are pioneers in cancer genome sequencing and liquid biopsy technologies. For additional information, visit www.pgdx.com.

About Almac Diagnostic Services

We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs.

The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics.

About Almac Group

A unique culture delivering exceptional solutions

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Almac Group Raises £30k for Southern Area Hospice

kelly — Mon, 21 Dec 2020 09:00:00 +0000

Craigavon, Northern Ireland – 21 Dec 2021 – Employees from Craigavon-based Almac Group, the global contract development and manufacturing organisation, have raised an incredible £30,000 for Southern Area Hospice enabling them to continue their invaluable care and support to patients with life-limiting illnesses.

The money was raised through Almac’s annual raffle which, this year, offered over 110 fantastic prizes generously donated by the company’s suppliers, consultants and other businesses. Employees started purchasing online tickets in November with the chance to win a range of quality items including smart TVs, tablets, luxury hampers, hotel & gift vouchers and other amazing prizes.

Elaine Gibson, Almac Group’s Global Travel & Events Manager, commented: “This is the 14^th year we have held our grand draw and this is a record-breaking total. We are delighted that our employees have again risen to the challenge and donated this incredible amount of money for such a worthy cause. A huge thank you to all the companies who donated prizes and PRA, Tempsen and Westrock who made donations directly to Southern Area Hospice.”

Anne MacOscar, Corporate Partnerships Officer, Southern Area Hospice, commented: “Southern Area Hospice Services is delighted to have been selected to benefit from Almac Group’s Charity Raffle this year. Covid-19 has had a major impact on our ability to fundraise and has had a huge impact on the way we deliver our services. However, our beds are still full and patients and families still need us. Thank you so much for this incredible donation which enables us to continue to provide essential care and support to our patients and families in need through this very challenging time.”

The socially distanced draw took place on Monday 14^th December with Almac’s CEO, Alan Armstrong, selecting the winners at random from a large tombola. The event was filmed live and posted on the company’s intranet to enable employees to share the excitement of the raffle.

Earlier this year Almac announced an employee-driven initiative which saw 33 health and welfare organisations local to Almac’s 11 global facilities benefit from a total of £250,000. Read more here.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Granted Phase I Award Under the ‘Sustainable Innovation Fund’ to Aid COVID-19 Recovery

kelly — Thu, 10 Dec 2020 09:00:00 +0000

Craigavon, Northern Ireland – 10 December 2020 – Almac Sciences, a member of the Almac Group, has announced it has secured an award under ‘The Sustainable Innovation Fund: Small Business Research Initiative (SBRI) phase 1’ to undertake a project in order to help businesses across the UK recover from the impact of COVID-19 in a sustainable manner.

The initiative is being led by Innovate UK, the UK’s innovation agency, and is a SBRI competition, which will fund organisations to develop and demonstrate new products or services to help businesses and/or the public sector in the UK recover from the coronavirus pandemic in a sustainable manner, demonstrating the impact and potential of a clean growth-led recovery and transition to net zero.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company (Ireland), will lead a team of experts to complete the project entitled ‘Manufacturing Oxidative Products’ over the next 3 months. The funding received from the SBRI will enable the team to demonstrate both innovative flow chemistry and biocatalytic routes to oxidative products as a technology platform for exploitation by UK fine chemical and pharmaceutical industries.

The findings of the project will then be submitted to phase 2 of the Sustainable Innovation Fund and, if successful, could receive additional funding of up to £3 million over a 1-year period to continue the innovative research, development and testing.

Professor Moody commented “The team and I are excited to receive this phase I award from Innovate UK enabling us to conduct vital research into a sustainable method of manufacturing an adequate supply of oxidative products. The coronavirus pandemic has affected many businesses, and indeed individuals, across the world and we are proud to have been selected based on our expertise and capability, to play our part in the sustainable recovery process.”

Innovate UK Executive Chair Dr Ian Campbell said: “In these difficult times we have seen the best of British business innovation. The pandemic is not just a health emergency but one that impacts society and the economy.” He added “Almac’s project, along with every initiative Innovate UK has supported through this fund, is an important step forward in driving sustainable economic development. Each one is also helping to realise the ambitions of hard-working people.”

The COVID-19 pandemic has resulted in an unexpected and unparalleled disruption to UK jobs, businesses, the economy at large and society in general. Recovering will take considerable time and ongoing investment, but the opportunity exists to recover in a sustainable way, resulting in increased prosperity with lower carbon emissions.

This news comes just one month after Almac announced it has been awarded a grant of ~$500,000 by the COVID-19 Therapeutics Accelerator towards developing cost effective, scalable processes for the production of the active pharmaceutical ingredient (API) of the drug remdesivir. Find out more here.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

About Innovate UK

Innovate UK drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas.

We connect businesses to the partners, customers and investors that can help them turn ideas into commercially successful products and services and business growth.

We fund business and research collaborations to accelerate innovation and drive business investment into R&D. Our support is available to businesses across all economic sectors, value chains and UK regions.

Innovate UK is part of UK Research and Innovation. For more information visit www.innovateuk.ukri.org.

About SBRI

The SBRI programme uses the power of government procurement to drive innovation. It provides opportunities for innovative companies to engage with the public sector and gain contracts to solve specific problems.

Competitions for new technologies and ideas are run on specific topics and aim to engage a broad range of organisations.

SBRI enables the public sector to engage with industry during the early stages of development, supporting projects through the stages of feasibility and prototyping. For more information visit https://www.gov.uk/government/collections/sbri-the-small-business-research-initiative.

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Almac Group Works to enable efficient manufacturing of remdesivir in Response to COVID-19

kelly — Tue, 17 Nov 2020 08:00:00 +0000

Grant awarded from the COVID-19 Therapeutics Accelerator

Craigavon, Northern Ireland – 17th November 2020 – Almac Sciences, a member of the Almac Group, has been awarded a grant of ~$500,000 by the COVID-19 Therapeutics Accelerator towards developing cost effective, scalable processes for the production of the active pharmaceutical ingredient (API) of the drug remdesivir.

Remdesivir, an antiviral medication, is the first drug to be approved by the US Food and Drug Administration (FDA) as a treatment for COVID-19 after a trial showed it cut recovery time by five days. In order to ultimately lower raw material usage, increase global yields and lower the overall cost of goods (COG) for the remdesivir development process, Almac Sciences has devised a plan to improve the overall route of synthesis to remdesivir including application of synthetic flow methodology and biocatalysis.

This investment supports efforts to combat the COVID-19 pandemic through the rapid process development and manufacturing of remdesivir.

“We are delighted to receive funding from the Therapeutics Accelerator to apply our skills in the fight against COVID-19,” said Dr Stefan Mix, Head of Biocatalysis, Almac Sciences. “With the skillset of our multidisciplinary teams, we are confident that our developmental approach to the manufacture of remdesivir will positively impact patients’ lives who are in urgent need, regardless of their location.”

“This project highlights Almac’s strength in technology deployment through application of both innovative flow chemistry and biocatalysis technologies to support development of processes which are economical, greener and safer to perform” says Prof. Tom Moody, VP of Technology Development and commercialisation at Almac Sciences and Arran Chemical Company.

The COVID-19 Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard, with funding from an array of public and philanthropic donors to speed up the response to the COVID-19 pandemic by funding the identification, assessment, development and scale up of treatments.

This news comes just six months after Almac announced it was supporting two COVID-19 clinical studies in Sub-Saharan Africa through a grant also awarded from the COVID-19 Therapeutics Accelerator.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Welcomes COVID-19 Vaccine Trial News Announced by Pfizer & BioNTech

kelly — Tue, 10 Nov 2020 19:03:53 +0000

Craigavon, Northern Ireland – 10 November 2020 – Almac Group, the global contract development and manufacturing organisation, has welcomed the exciting news from Pfizer, and its German partner, BioNTech, that its potential COVID-19 vaccine showed better than 90% efficacy in their pivotal Phase III trial.

Almac Clinical Services is proud to support its client, BioNTech, by performing a range of services including secondary labelling, storage, distribution, provision of depots, temperature management through its TempEZ™ platform, drug returns and pharmacist services across the globe.

Commenting on the development, Dr Robert Dunlop, Managing Director & President, Almac Clinical Services, stated “We are delighted with their announcement that significant progress has been made in this trial. The extremely positive news that we may see a vaccine being approved for use before the end of the year is the development the world has been waiting for and we are proud to have played our part.”

Global VP of Operations, Donna Christopher, who led the project for Almac added: “We are both proud and privileged to support this clinical study through a range of services which has enabled us to play our part in the fight against COVID-19. I would like to offer our congratulations to the diligent teams at Pfizer and BioNTech for their work thus far, and to thank those within Almac for all their work in support of this. Everyone at Almac wishes Pfizer and BioNTech every success as they continue their excellent work to hopefully bring this pandemic to an end.”

In addition to the services listed above, Almac’s bespoke temperature controlled shipping solution, the Almac Pod™, is being used to transport the vaccine in the required frozen condition to investigator sites across the world. This offers a protected, optimised and dynamic solution that safeguards the product and mitigates against temperature changes throughout transit using advanced phase change technology thereby ensuring the patient receives a stable, fit-for-purpose drug which has not been compromised at any stage.

Almac Group continues its partnership with a variety of other global pharmaceutical, biotech and research institutions to support over 80 separate crucial research projects into COVID-19 treatment options. The Group is supporting this urgent research need through a range of service areas, including analytical services, peptide development, expedited Interactive Response Technology (IRT) support and clinical trial manufacturing, packaging and distribution.

Find out more – https://www.almacgroup.com/almac-is-proud-to-support-multiple-programs-to-accelerate-covid-19-treatment/

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Continues HLA Scheme for Aspiring Scientists, Technologists and Engineers

admin — Wed, 04 Nov 2020 09:00:00 +0000

On-the-job training programme maximises career development potential

Craigavon, Northern Ireland – 04 November 2020 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is continuing its successful Higher-Level Apprenticeship (HLA) programme enabling students to earn a salary whilst developing their experience, maximising their career development potential and completing a structured programme of tailored on-the-job training.

The multifaceted scheme offers HLAs in Applied Industrial Sciences (Chemical Sciences), Computing and Mechatronic Engineering giving access to key departments and globally respected experts across multiple disciplines. Available for both existing and newly recruited employees, Almac’s programme has been operating for the last five years and is delivered through the ApprenticeshipsNI programme, in association with Southern Regional College (SRC).

To date, Almac’s intake has been extremely popular with over 30 HLAs being recruited in various departments by the global organisation. Apprentices who participate in the programmes can work in a high-quality, customer focused, innovative environment and are fully supported by both an expert Almac mentor and a personally assigned assessor from SRC.

Almac’s HLA programme illustrates a shift in the employment of apprenticeships by employers across the UK. While the total number of apprenticeships has been declining for several years, new schemes are being created to attract school leavers to highly technical roles or provide practical training for existing employees.

“The success of our business depends on having a diverse workforce of suitably trained and qualified staff,” said Dr Frances Weldon, STEM Outreach Manager, Almac Group. “Offering different pathways into the various opportunities available at Almac is a fundamental part of that and we have no doubt that the incorporation of apprenticeship programmes to recruit staff into our labs, engineering and IS teams will mean we can grow a talent pipeline from within our organisation.”

Michelle McKinstry graduated with a BSc Degree this summer having completed her HLA in Applied Industrial Sciences (Chemical Sciences) with Almac Sciences over the past 4 years. Now employed full time as an Analytical Chemist, Michelle reflects on her pathway: “The HLA is a brilliant experience, challenging, but very rewarding and it has enabled me to earn while I learn, without paying any tuition fees or running up any student debt. I have developed new skills and increased my knowledge of the pharmaceutical industry. The experience I have gained has been invaluable and working at Almac has given me the confidence to progress and succeed in my chosen career path.”

For further information regarding the various HLA opportunities available at Almac visit almacgroup.com/careers/apprenticeships.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Sciences Achieves Thought Leadership Milestone

kelly — Wed, 14 Oct 2020 07:00:00 +0000

Professor Tom Moody Exceeds 100 Technical Publications Since Tenure at Almac

Craigavon, Northern Ireland – 14 October 2020 – Almac Sciences, a member of the Almac Group, is pleased to congratulate Professor Tom Moody, VP of Technology Development and Commercialisation, for achieving the impressive milestone of over 100 peer reviewed publications since beginning his tenure with the organisation.

Professor Moody is a seasoned technical expert in chiral chemistry and biocatalysis with more than 18 years of extensive academic and industry experience. In recent years, his publications have centred on the economic and environmental benefits of “green” chemical methods, including biocatalysis, a direct and simple way to synthesise complex achiral and chiral compounds, and most recently innovations in continuous flow chemistry.

At Almac Sciences and Arran Chemical Company, Professor Moody is responsible for driving new technology processes from conception to commercial scale-up across multi-disciplinary research including enzyme engineering, biocatalysis, flow chemistry, isotope chemistry, custom synthesis and commercial production.

He previously held the role of Head of Biocatalysis and Isotope Chemistry, where he led the development of Almac Sciences’ Biocatalysis Technology platform selectAZyme^TM. He also played an integral role in the integration of Arran Chemical Company Ltd into Almac Sciences and ensured smooth transfer of manufacturing projects from Craigavon to the Arran site in Athlone, Ireland.

Professor Moody is a tenured honorary professor at Queens University Belfast in the area of Green Chemistry. In addition to his accolades in Chemistry including a Bachelor of Science (BSc) in Chemistry (First Class Hons) and a PhD in Organic Chemistry he holds a Master’s in Business with Distinction in Business Strategy.

Professor Moody commented, “At Almac Sciences, it is a fundamental value of our organisation to be innovative and share acquired technical knowledge that will advance our industry, particularly in areas that can reduce the environmental impact and cost of chemical production. I am grateful for the many opportunities I have received to share the innovative methods we’re developing with the wider industry and academic communities through publication and look forward to the continued opportunity to do so in the future.”

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Appoints Vice President of Small Molecule API

kelly — Wed, 07 Oct 2020 07:00:00 +0000

Craigavon, Northern Ireland – 06 October 2020 – Almac Sciences, a member of the Almac Group, has announced the appointment of Dan Bayston as Vice President of Small Molecule API.

Dan has been a key member of the company’s global Chemical Development and Scale-up team for the past 17 years. His unique knowledge, strong technical background and delivery track record has driven significant innovation in our service offering during this time and, in recent years, he has become increasingly involved in customer management, business performance assessment and business strategy.

Dr Stephen Barr, President & Managing Director, Almac Sciences, commented “Dan’s experience, credentials and working relationship with both his team, and the wider Business Unit, makes him a well-respected leader. This promotion is well deserved and I, and the rest of the Sciences’ Executive team, look forward to working with him in his new role.”

Prior to joining Almac in 2003, Dan completed a BSc at the University of Sheffield, a PhD at the University of Louvain-la-Neuve (Belgium) and held a Post-doctoral research position at the University of Oxford.

In addition, he has almost a decade of experience in various process development roles with a UK based chemical services company.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia. To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

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Almac Group Ranked Second in Belfast Telegraph’s “Businesses making the largest contribution to incomes” Table

kelly — Wed, 30 Sep 2020 15:57:16 +0000

Moves to Number Eleven in “Top 100 Companies” List

Craigavon, N.I., 30 Sep 2020 – Craigavon based Almac Group, the global contract pharmaceutical development and manufacturing organisation, is honoured to take the number two spot in this year’s Belfast Telegraph “Businesses making the largest contribution to incomes” table. In addition, in a table listing Northern Ireland’s “Top 100 Companies” the company has moved up eight positions to number eleven.

The table ranks the most successful Northern Ireland-registered companies in order of pre-tax profits and has been described as a “timely reminder of the ongoing strength and diversity of our economy”. Company accounts from across Northern Ireland were analysed by top economist John Simpson to create the list and inevitably pre-date Covid-19.

The news comes as the Group’s figures for year ending 30 September 2019 reported a £85.4 million rise in turnover at £634.3 million with pre-tax profits recorded at £47.6 million, up from £27.6 million, while average global employee figures increased from 4,798 to 5,150 during the same period. Since these figures were published, much has changed in the pharmaceutical industry as a result of the impact of the current pandemic, however Almac continues to conduct its critical business operations across all its locations and is currently supporting over 80 separate crucial research programs to accelerate COVID-19 treatment.

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Almac McKervey Award Presented for Excellence in Chemistry

davidkane — Tue, 29 Sep 2020 08:00:00 +0000

Craigavon, N.I., 29 Sep 2020 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has today announced this year’s recipient of the ‘Almac McKervey Award for Excellence in Organic Chemistry’.

The award, established in 2018 as a commemoration to the life and work of one of Ireland’s most distinguished scientists, Professor Tony McKervey, who passed away in June 2017, was made to Queen’s University Belfast MChem in Medicinal Chemistry student, Sinead McCann.

Dr Stephen Barr, Managing Director and President, Almac Sciences, announced the winner at the Queen’s School of Chemistry and Chemical Engineering virtual Graduation awards ceremony on 22nd July. In his video address, Dr Barr made reference to the truly monumental period where, due to the pandemic, the profile given to science and scientists has never been higher, offering the Graduates of 2020 the opportunity and potential to make a real difference in the world by combining their skills, knowledge and talent with others to support global health, socio-economic and environmental challenges.

Sinead, who is from Magherafelt, also received a £1,500 bursary towards her tuition fees and a 12-month placement with Almac to gain practical industry experience and mentorship in process development chemistry.

Dr Stephen Barr said: “I am pleased to present this year’s Almac McKervey Award to Sinead in memory of our esteemed colleague and friend Tony whose commendable leadership and kind manner inspired many of us during his long service with Almac. Sinead has demonstrated exemplary performance throughout her degree to date and I hope, that in receiving this recognition today, she will progress to a long and rewarding career in chemistry. Many congratulations.”

Upon receiving the award, Sinead said: “I am delighted to have won this year’s Almac McKervey award and am excited to carry out my placement at Almac. The experience and insight I will be exposed to will certainly help me develop my wider chemistry understanding, introduce me to new techniques and help me develop my skills further.”

Sinead’s name was added to the perpetual commemorative wall plaque at the David Keir building at Queen’s- a replica of which is displayed at Almac’s global headquarter facility in Craigavon.

Born in Ederney, Co Fermanagh in 1938, Tony earned a degree in Chemistry from Queen’s in 1961. A former Professor of Organic Chemistry at both University College Cork and Queen’s University Belfast, Tony founded Almac’s Sciences Business Unit in 1992 and continued to support Almac as a member of the Sciences’ senior management team until his death at the age of 78.

The Almac McKervey Award, which is open to students studying Chemistry or Medicinal Chemistry at the School of Chemistry and Chemical Engineering, Queen’s, is presented each year to the top applicant, selected on both their academic achievement and performance at an interview with Almac’s chemistry experts.

#END#

Notes to Editor

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac McKervey Award Presented for Excellence in Chemistry appeared first on Almac.

Almac Group Launches Biologics Testing Solutions

davidkane — Thu, 24 Sep 2020 07:00:00 +0000

Comprehensive and flexible service accelerates biologics development and approval

Athlone, Ireland – 24 September 2020 – Almac Sciences, a member of the Almac Group, has announced the expansion of its existing suite of analytical solutions to include biologics testing.

This new offering follows the announcement of the company’s expansion of its Irish laboratory in 2019 and from which Almac Sciences now provides a comprehensive range of flexible pharmaceutical testing services to support clients’ drug development programs adhering to industry regulations including FDA, EMA and PMDA, under GMP standards

Almac’s new services include GMP lot release and stability testing to support clients’ drug substance and drug product programs for both novel biologics and biosimilars; fit-for-purpose analytical method development / phase-appropriate method validation; raw material testing for microbial and mammalian expression systems that comply with pharmacopeial requirements and clients’ specifications.

The expansion of biologics analytical testing solutions complements the well-established range of analytical services already offered from Athlone as well as its global headquarter campus in the UK and facility in Pennsylvania, North America. Currently employing over 150 highly skilled scientists globally, this investment will see an increase to its existing workforce to meet continued client demand. In order to provide additional leadership and site management to ensure the continued execution of this expanded offering, two key posts have been appointed within the last six months.

Simon Cocks has been appointed as Athlone Site Manager and, with a PhD in Analytical Chemistry from Loughborough University, brings over 25 years’ industry experience to the role. Prior to joining Almac, he managed multifunctional/multisite technical and support teams within both the CRO/CDMO and pharmaceutical industries. He is a chartered chemist and a Fellow of the Royal Society of Chemistry and brings with him a wealth of knowledge including discovery and development, manufacture, clinical analysis and commercial supply of both small and large molecules in all of the GxP regulatory sectors.

Pavan Kumar Kunala has been recruited as Biopharma Lab Manager, also based at Almac’s Athlone facility. Pavan has a strong background in the field of analytical development for biologics, with over a decade of experience. In his previous roles at Intas Biopharmaceuticals and Pfizer, he was responsible for leading a team of scientists to support analytical method development, validation and overall CMC strategy for the advancement of early, late and commercial biologics. Pavan holds a M.S. degree in Biological Sciences from Arkansas State University.

Dr John Robson, Vice President Analytical Operations at Almac Sciences, commented: “Biologics have gained huge traction in the last decade and are poised for stronger growth in the coming years with potential to significantly impact patient lives. The launch of this service offering furthermore demonstrates Almac’s commitment to offering a best-in-class service to our global client base and in advancing human health. We are confident the addition of biologics testing solutions will continue to strengthen our competitive position in the marketplace.”

Amid the current COVID-19 pandemic, Almac Sciences is now offering virtual auditing solution for clients on request.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Clinical Technologies Named Leader in Key Industry Report

davidkane — Wed, 09 Sep 2020 13:00:00 +0000

IXRS®3 selected as preferred IRT application on flexibility, quality, and project management

Souderton, P.A., USA – 09 September 2020 – Almac Clinical Technologies, part of the global contract pharmaceutical development and manufacturing organization, the Almac Group, is proud to announce its innovative Interactive Response Technology (IRT) application, IXRS®3, has been named as the industry’s most preferred IRT application, globally.

Industry Standard Research (ISR)’s ‘IRT Market Dynamics and Service Provider Benchmarking report’, published in August 2020, is designed to help key decision makers across the eClinical ecosphere stay current with market dynamics and anticipate industry changes. Feedback was assessed from over 100 respondents throughout the professional IRT community, and the results are categorized by IRT supplier performance and preference metrics.

Almac’s IXRS3 solution was ranked first in the “IRT Vendor Preference” section out of over 20 global companies, a spot it shared with Parexel Informatics’ ClinPhone product, and was chosen based on respondents’ experience with the platform and its demonstrable flexibility, high quality, and superior project support.

Used in over 3,000 clinical trials in over 120 countries, IXRS3 is available in multiple modalities and is the most configurable and customizable IRT available. From Phase I through to IV, simple designs to complex adaptive trials, the application can accommodate any permutation of study objectives, and is fully supported by a team of professional biostatisticians, language and integration experts. Almac’s recent partnership with Exostar enhanced the IXRS3 platform by enabling Single Sign-On (SSO) capabilities for users through a standardized integration.

As part of Almac’s commitment to innovation and providing a better IRT experience for clinical trial operations, the company announced the launch of its next-generation IRT solution, Simplify^TM, in June. The solution is the result of analyzing over 3,000 clinical trial protocols to identify common functionality available for consolidation into a pre-validated and configurable ecosystem that enables deployment in four weeks or less. Simplify is powered by IXRS3 technology and is designed to accelerate the study start-up process with greater efficiency.

Valarie Higgins, President & Managing Director, Almac Clinical Technologies said: “We’re honored to be recognized as an industry leader in this renowned benchmark of global IRT Market Dynamics and Service Providers. This is a fantastic achievement and testament to the hard work and creativity of the Almac Clinical Technologies’ team. For over 25 years, our strategy has been focused on the delivery of innovation, service, and quality in the IRT landscape, and we are truly humbled that the clinical development community continues to value and share our priorities.”

Notes to Editors

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CBS This Morning Features Pfizer’s Phase 3 COVID-19 Vaccine Trial

davidkane — Wed, 09 Sep 2020 09:56:18 +0000

Clinical study supported by Almac Clinical Services

Almac Group is proud to be continuing our partnerships with a variety of global pharmaceutical, biotech and research institutions to support over 80 separate crucial research projects and having further discussions with clients on how we can support an additional 50 programmes.

Almac Clinical Services is currently supporting a clinical study which has been featured as part of CBS This Morning’s Coronavirus “The race to respond” series. On 21st August “The race for a vaccine” feature focused on Pfizer and BioNTech’s vaccine trial, now in phase 3, where CBS’s Chief Medical Advisor, Dr John Lapook, reported on the progress of the clinical trial programme and the incredible milestones achieved thus far.

Almac is currently performing secondary labelling, storage, distribution, depots, TempEZ™ life cycle management, adjudication and pharmacist services for this product. The video footage used for the CBS report shows the use of Almac’s bespoke temperature controlled shipping solution, the Almac Pod™, which is used to transport the vaccine in the required frozen condition and safeguards the product against temperature changes throughout transit. This ensures the patient receives a stable, fit-for-purpose drug which has not been compromised at any stage.

Dr Robert Dunlop, Managing Director, Clinical Services commented: “We are proud to be playing our part in the fight against COVID-19 and the inclusion of our innovative shipping solution, the Almac Pod, in this CBS report for the current Pfizer and BioNTech’s phase 3 study is really poignant as it acts as a reminder of how the work we do on a daily basis directly contributes to the well-being of patients right across the world. We wish Pfizer and BioNTech, and indeed all our partners, every success with finding an effective treatment or vaccine to help end this pandemic.”

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Arran Chemical Company Continues Unique Industry – Academia Collaboration with Athlone Institute of Technology

davidkane — Tue, 08 Sep 2020 07:19:44 +0000

Announcing a new four-year PhD scholarship to deliver greener and more economic alternatives to chemical production methods

Athlone, Ireland, 08 Sept 2020 – Arran Chemical Company, a member of the Almac Group, has embarked on its second collaboration project with Athlone Institute of Technology (AIT) to support a four-year PhD programme which will investigate a novel library of Laccase enzyme biocatalysts in oxidative green chemistry.

Leading the project is Hong Ann Gan, the 2020 recipient of AIT’s President’s Doctoral Scholarship award. Hong recently completed a BSc (Hons.) in Medicinal Chemistry and Chemical Biology at UCD achieving a First-Class Honours Degree and will commence the project in October. Hong, originally from Malaysia, will be jointly supervised by AIT’s Dr. Sean Reidy, Lecturer in Chemistry, Dr. Noreen Morris, Lecturer in Chemistry, in collaboration with Professor Tom Moody, VP of Technology Development and Commercialisation, Almac Sciences & Arran Chemical Company and Dr. Peter Cairns, Technical Manager, Arran Chemical Company.

The project will focus on greener and more economic alternatives to chemical production methods for the synthesis of oxidative products which is currently an under resourced and studied area. This technology will find application in both pharmaceutical and fine chemical industries. Laccases are considered by many in the biotechnology field as the ultimate green catalyst due to the myriad of functional transformations, broad substrate specificity and relative autonomy due to the fact they only produce water as a by-product. In addition, the high stability, selectivity and mild reaction conditions, make these enzymes particularly attractive as oxidative catalysts for chemical synthesis. It is therefore essential that new methodologies are explored to expedite their use.

This Laccase project has the backing of Professor Moody, who commented: “We are delighted to be supporting AIT once again and look forward to working together over the next four years. Almac will supply the college with all the necessary biocatalysts needed for this investigation and, of course, guidance and expertise from our specialists in this field. We wish Hong every success in his PhD project.”

Dr Reidy stated “This project has the exciting prospect of exposing both the student and supervisors to new and exciting areas of research. A collaboration with Arran Chemical Company, an established global chemical company with a wealth of experience which works with clients globally, will raise the profile of Athlone Institute of Technology as a base of R&D excellence and lead to further opportunities for collaborative research in the future.”

AIT has established strong links with Arran Chemical Company over many years and, together, have carried out a variety of projects on the synthesis and separation of chiral amines. This project is the second such Academia – Industry collaboration between the Almac Group and AIT in recent years. The first project was initiated last summer and focused on the use of biocatalysis in the asymmetric synthesis of chiral amines and diamines. Lauryn Bracken, a recipient of AIT’s President’s Doctoral Scholarship award (2019), is undertaking this work as part of her PhD studies.

#END#

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Almac Group Donates a Quarter of a Million Pounds to Global Charities in Wake of COVID-19

davidkane — Wed, 02 Sep 2020 14:48:56 +0000

Employee-driven initiative will benefit 33 health and welfare organisations local to Almac’s 11 global facilities

Craigavon, Northern Ireland – 02 September 2020 – Almac Group has today announced the organisation will donate £250,000 to 33 charities globally to support their critical work in the wake of COVID-19.

Each year Almac hosts a summer “family fun day” at each of its locations, bringing together employees and their families to enjoy a full day of socialising, games and events. As the global organisation continues to focus on the wellbeing of all its employees throughout the global COVID-19 situation and, with social distancing remaining a priority, these fun days were unable to proceed.

Recognising that charitable organisations rely on significant donations typically received via monthly events and fundraising, and that those efforts have ceased as a result of the pandemic, Almac deemed it appropriate to use the money which would have been typically spent on its fun days to make a contribution to a number of registered charities in each of its localities. The company launched a localised employee survey to determine which regional charitable beneficiaries would receive a share of a quarter of a million pounds total contribution.

Each of Almac’s 5,600 employees across 11 main facilities located in the U.K., Europe, Asia and North America were given the opportunity to select those charities they deemed most important to their local communities, yielding 3 beneficiaries per location. A total of 33 organisations were selected to receive a donation in direct response to Almac’s employee feedback and cover a wide range of missions ranging from childhood welfare, hunger, cancer support, hospice and social justice causes.

Alan Armstrong, Group CEO, commented: “As a global organisation, Almac’s mission is to advance human health, and we recognise that this extends to supporting the health and wellbeing of our local communities, especially during a global pandemic. In response, we are honoured to support 33 organisations, chosen by our employees, which support the health and welfare of our neighbours in each of our corporate locations, and we are proud to give back during this unprecedented time.”

The global organisation is also partnering with a variety of global pharmaceutical, biotech and research institutions to support over 80 separate crucial research projects into COVID-19 treatment options. These vital projects cover a range of different areas including vaccines and various potential treatments for symptoms and the effects of this disease. Find out more https://www.almacgroup.com/almac-is-proud-to-support-multiple-programs-to-accelerate-covid-19-treatment.

Notes to Editors

Almac Group hosts annual fun events for all employees and their immediate families in each key location. Given the exceptional circumstances brought about by COVID-19 pandemic, in 2020 the Almac Group executive team agreed to combine the money typically spent on organising these multiple events and supplement the total in order to enable a donation of a quarter of a million pounds Stirling.

About Almac Group

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Almac Group Moves to Number Five in Ulster Business Top 100 Companies List

davidkane — Thu, 20 Aug 2020 10:19:18 +0000

2018/19 figures report turnover increased by £85M with 7% growth in global workforce

Craigavon, N.I., 20 Aug 2020 – Craigavon based Almac Group, the global contract pharmaceutical development and manufacturing organisation, is honoured to move up three positions to number five in this year’s Ulster Business “Most valuable businesses” table.

For the third consecutive year, the Group was also listed in a supplementary report detailing the “Most profitable companies in Northern Ireland”, and moved up from tenth place in 2019 to this year’s number eight.

Niall Harkin, Almac Group Finance Director, commented: “We are delighted to see Almac placed at number five in this year’s Ulster Business Top 100 companies tables. 2019 was a highly successful year for Almac as we continued to invest significantly in our people, facilities and unique solutions to ensure our growing client base are offered the most flexible, innovative and efficient services in our marketplace with the sole aim of advancing the health of patients across the world. Achieving recognition in these listings, and indeed our overall success, is testament to the dedication, expertise and contribution of our ever increasing global and diverse employee base.”

The Ulster Business Top 100 list has showcased the performance of the biggest firms from right across Northern Ireland, ranked by turnover, for more than 30 years. The annual report is sponsored by A&L Goodbody and uses a combination of data sourced from both Dun & Bradstreet’s information database and Companies House. It incorporates the results of Northern Ireland based companies, either Northern Ireland registered, or when a significant portion of their business is driven and transacted through the province.

ENDS

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Almac Clinical Services Launches Virtual Auditing Solution for Clients

davidkane — Tue, 11 Aug 2020 12:00:00 +0000

Digitising conventional on-site audits to ensure continued quality and regulatory compliance for clinical trials

Craigavon, NI – 11 Aug 2020 – Almac Clinical Services has digitised its conventional on-site auditing process and launched a virtual auditing solution for clients. This is to ensure continued quality and regulatory compliance during the current COVID-19 pandemic, maintain GMP standards and deliver on the terms of quality and technical agreements all whilst protecting employees and upholding social corporate responsibility to partners and suppliers. Global clients can realise clear advantages saving time and money otherwise spent on travel and accommodation requirements.

Within the clinical supply industry, there is a significant emphasis on robust supply chain processes. Audits are essential and play a critical role in ensuring clients can continue to deliver and meet regulatory standards. With continued advances in technologies available for business communication and as a direct response to travel restrictions and social distancing measures posed by the current pandemic, postponing audits is not a long-term option. Almac is therefore offering a series of alternative auditing strategies for its clients, enabling them to facilitate ongoing clinical trials and accelerate timelines for COVID-19 studies.

“With a changing clinical trial landscape and the need for an adaptable business model due to impacts of COVID-19, Almac continues to innovate and provide solutions for clients,” said Dr Robert Dunlop, Managing Director & President, Almac Clinical Services. “Our clients are supporting complex, global clinical studies and we understand the pressures they face at this time. In fulfilling our obligation to ensure quality oversight, it is important Almac continues to provide an environment where traditional systems and procedures can be suitably challenged and adapted.

Combining best-in-class technology and Almac expertise, our remote auditing service is now operational, accepted by industry regulators and built to support three components of a conventional industry audit. They include auditing of Almac Clinical Services’ global facilities, QP auditing of sponsors’ manufacturing sites and audits of Almac vendors’ facilities. This new service is the latest development in our ongoing program of solutions that will help sponsors face the challenges that the clinical supply chain of tomorrow may bring.”

1) Virtual auditing of Almac facilities for clients

A customised and comprehensive digital audit programme is agreed between Almac and the client as a first step in this process. The virtual audit is designed to deliver upon three core elements from the standard conventional site-based audit. They include a tour of Almac’s facilities to review manufacturing processes in operation; a document review session, harnessing secure content collaboration platforms and dialogue with Almac’s subject matter experts. Two virtual tour options are available for clients. Almac Clinical Services is providing 3D pre-recorded virtual tours plus 3D live streaming virtual tours of Almac’s facilities.

Dialogue is held via interactive and collaborative technologies to facilitate remote communication for clients. This is a central part of the audit to ensure that areas of importance for sponsors are addressed as they would be if on-site, with a dedicated question and answer session with Almac’s team of global clinical supply experts.

2) Almac qualified persons (QP) quality audit of client sites

Almac Clinical Services is committed to ensuring clients uphold quality standards and regulatory compliance and ensure their contracted organisations supply goods and services that are fit for use and meet the terms of quality and technical agreements. Using the same technology to host customer audits, Almac’s QPs are carrying out due diligence audits to provide assurance that the relevant systems and processes are in place at sponsors’ manufacturing sites whilst addressing the EU regulatory expectations and enabling continuation in the supply of vital medicines to patients.

3) Quality audits of Almac suppliers

As businesses expand operations and supply chains across international borders, it is increasingly important to have a cohesive approach to quality, safety and sustainability goals. To ensure the reliability of our suppliers, Almac Clinical Services’ supplier quality team can harness the same interactive and secure technologies. Virtual auditing is a robust method to safeguard the same high standards of quality and regulatory compliance throughout the entire clinical supply chain.

ENDS

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Almac Group “CATCH”es a SFI Industry Fellowship

davidkane — Wed, 22 Jul 2020 07:00:00 +0000

Collaboration with University College Dublin further expands its continuous flow platform

Craigavon, N.I., 22 Jul 2020 – Almac Sciences, a member of the Almac Group, “CATCH”es a prestigious Science Foundation Ireland (SFI) Industry Fellowship in collaboration with University College Dublin’s (UCD) flow chemistry specialist, Dr. Marcus Baumann. The Industry Fellowship Programme aims to enhance industry-academia collaborations through funding of research projects focused on knowledge exchange to drive excellence and innovation throughout Ireland.

CATCH – derived from continuous biocatalysed chemicals – underlines a commitment to develop new sustainable technologies that enables the competitive, and environmentally friendly, manufacture of chemical intermediates and active pharmaceutical ingredients (APIs) via the synergetic marriage of continuous flow and biocatalytic processes.

Upon winning the Fellowship, Dr. Baumann commented “This project will enhance my academic profile by extending my research portfolio into industrially relevant fields through close collaboration with a world leading industrial partner like Almac.”

Professor Tom Moody, VP Technology Development and Commercialisation at Almac Sciences and Arran Chemical Company further commented “The CATCH strategy will continue our commitment to exploit sustainable biocatalytic processes to synthesise chemicals in an on-demand flow fashion, thereby minimising the amount of by-products formed and demonstrating the synergies between our flow chemistry and biocatalysis platforms. Importantly, the CATCH project will continue to strengthen industrial and academic knowhow in this exciting field.”

Almac’s flow chemistry experts, Dr. Scott Wharry and Dr. Megan Smyth, are delighted to be working with Dr Baumann and his team at UCD. This news comes in addition to their existing collaboration with Queen’s University Belfast in the area of flow research (APPFlow), which secured a Horizon 2020 funded Innovative Training Network (ITN) Marie Skłodowska-Curie programme to support 4 PhD studentships over 4 years.

The expertise developed throughout this project will further expand Almac’s existing flow chemistry platform ensuring Almac continues to offer customers the best available technology to meet their demanding processing needs today, tomorrow and in the future.

ENDS

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Almac Group Announces Winners of claraT Grant Programme for Academia

davidkane — Tue, 21 Jul 2020 06:00:00 +0000

Over $280,000 of gene expression analysis awarded to 10 cancer researchers

Craigavon, N.I., 20 Jul 2020 – Almac Diagnostic Services, a member of the Almac Group, is pleased to announce the winners of its inaugural clara^T* ‘Grant Programme for Academic Cancer Researchers’. Worth

$287,000 of data analysis in total across all winners, ten selected research institutions globally will now each have the chance to utilise Almac’s clara^T software solution to further their gene expression cancer research projects.

Academic research scientists may not always have access to expertise in the comprehensive analysis of gene expression data, which could ultimately help fast-track biomarker discovery and translational research.

Almac invited global academic research scientists, with an oncology focus, who had access to good quality gene expression data, to submit applications providing details of their project and how clara^T could benefit their cancer research efforts.

The 10 successful grant recipients are:

Cancer Researcher	Institute	Disease Indication
USA
Wei Zhang PhD	Northwestern University	Glioblastoma
Zhou Zhang PhD
Analiz Rodriguez MD, PhD	University of Arkansas	Brain Metastasis
Jarod Barrott PhD	Idaho State University	Osteosarcoma
Gjumrakch Aliev MD, PhD	GALLY Research Institute	Lung Carcinoma & Sleep Apnea
Canada
Prof Tarek Bismar	University of Calgary	Prostate Cancer
Europe
Verena Wally PhD	Medical University of Salzburg, Austria	RDEB/SCC
Dr Yue Zhao	University Hospital of Cologne, Germany	Gastrointestinal Cancer (GI)
Dr Mariano Ponz-Sarvise	Clinica Universidad de Navarra, Spain	Pancreatic Cancer
Dr Vincenzo Corbo	University of Verona, Italy	Pancreatic Cancer
Antonella Verrienti PhD	Sapienza University of Rome, Italy	Thyroid Cancer
Prof Anna Maria Cimini	University of L’Aquila, Italy	Glioma

The full Academic institution information and Academic researcher titles can be found here: https://www.almacgroup.com/diagnostics/claratreport/almac-clarat-grant-programme-for-academia/

Professor Richard Kennedy, Almac Diagnostic Services’ Global VP of Biomarker Development & Medical Director, commented: “Congratulations to all the successful Almac grant recipients. We wish them every success as they continue their research efforts, new discoveries and future publications. Almac are delighted to play a part in that journey. We are pleased to be able to offer this opportunity to cancer research scientists where Almac will cover the costs associated with utilising clara^T to help classify gene expression data. Ultimately, with a view to better understanding the significance of the underlying biologies, which could lead to novel combination or targeted therapies in the future.”

Grant applications were received from across the US, Canada and Europe. All submissions were reviewed by a multidisciplinary scientific review panel, highly experienced within the cancer research field. The review panel, comprised of Dr Kienan Savage from Queen’s University Belfast PGJCC (The Patrick G Johnston Centre for Cancer Research), Almac’s Dr Laura Knight, Global VP of Data Sciences and Dr Nuala McCabe, Biomarker Research Manager, ranked and selected the winning grant projects based on the submission pre-defined selection criteria. Applications were assessed on the study design, the translational significance & the potential to generate data for publication within a year.

Each recipient will be given the opportunity to use Almac’s innovative clara^T software solution which provides a concise, easy to interpret report ,with over twelve months of bioinformatic analysis in just a couple of days. Almac clara^T reads out 92 unique gene expression signatures across all 10 Hallmarks of Cancer^ – A process which typically requires deep technical expertise and significant time & money investment.

One winner, Dr Wei Zhang, Associate Professor, Department of Preventative Medicine, from Northwestern University Feinberg School of Medicine (Chicago, USA), upon receiving the Almac grant award, stated what this would mean for their research: “Having won this Almac grant award, we are very pleased to have an opportunity to utilise an innovative tool that could provide us with novel insights into gene networks and pathways that are related to glioblastoma and patient survival.”

Further information on Almac clara^T Total mRNA Report can be found here: almacgroup.com/diagnostics/claratreport

* clara^T is a unique software driven solution, classifying the most biologically relevant gene expression signatures into a comprehensive easy-to-interpret report. Note: clara^T is for research use only (RUO) and is not to be used for diagnostic or prognostic purposes, including predicting responsiveness to a particular therapy.

ENDS

Notes to editors

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Almac Group Launches Tempod® 1000 to Improve Clinical Site Temperature Data Management

davidkane — Wed, 24 Jun 2020 12:00:00 +0000

Innovative USB extends established temperature management service for sponsors and patients

Durham, N.C., 24 June 2020 – Almac Clinical Services, part of the Almac Group, the global contract pharmaceutical development and manufacturing organization, has launched Tempod® 1000 which bolsters the company’s Site Compliance and temperature management offering for sponsors.

An extension to Almac’s established temperature management service, Tempod 1000 is a USB device that captures and stores all clinical site temperature data and automatically identifies unreported excursions once uploaded into TempEZ™. Designed to remove the administrative burden of updating manual temperature logs, it also increases site compliance with reporting data and promotes best digital practice in clinical studies and patient safety.

Manual methods of data capture have proved challenging due to disruptions caused by the global pandemic. Many clinical sites are operating reduced hours and, in some cases, closing. The Tempod 1000 automates the process by continually recording temperature data for drug products stored at clinical sites, providing sponsors and CRAs with full, remote visibility thereby ensuring quality and integrity of the drug product.

“Tempod 1000 is an enhanced service for sponsors already benefiting from Almac’s Site Compliance module and TempEZ platform,” said Donna Christopher, Global VP of Operations, Almac Clinical Services. “It will save time and resource through automated collection of temperature data at the clinical sites. Not only will this relieve the pressure on site staff, but it also provides audit-ready temperature history that can be accessed remotely by the sponsor or CRAs. Almac is committed to digital transformation and recognises the value of replacing manual, paper-based processes.”

Tempod 1000 follows the recent launch of the Site Compliance module of Almac’s leading, web-based temperature data management system, TempEZ. The module, combined with Tempod 1000, is another step closer to our goal to digitize, visualize and manage the temperature data held by clinical sites. This will create an end-to-end view of temperature data within TempEZ and demonstrate products have been stored within the label claim at each stage in the supply chain, including at clinical sites where most temperature excursions occur.

In addition, Tempod 1000 will reduce the risk of missed patient visits due to unreported excursions, enable sponsors and CRAs to identify and resolve excursions remotely, speed-up CRA review time during site visits and facilitate timely and efficient study close-outs and database locks. Find out more about Almac’s TempEz solution here.

ENDS

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2018-19 Figures Show Almac Group’s Turnover Increased by £85M to £634M

laurenharris — Fri, 12 Jun 2020 14:24:29 +0000

7% growth in global workforce to over 5,100 during same period

Craigavon, N.I., 12 Jun 2020 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has reported an £85.4 million rise in turnover from £548.9 million to £634.3 million for its financial year 2018-19.

During this period, the revenue increase resulted in improved pre-tax profits which were recorded at £47.6 million, up from £27.6 million for the same period the previous year. Higher exchange gains on financial activities in the year also contributed to this profit level improvement.

Average employee figures increased from 4,798 to 5,150 during the same period. These figures were recorded in the organisation’s annual report for year ending 30 September 2019.

Throughout this period, the Group continued to invest heavily in its existing facilities across UK, Europe, North America and Asia. In addition, the organisation launched a number of innovative and unique solutions designed to offer greater efficiency to its global clients within the diagnostic, clinical trial and pharmaceutical development arenas.

Alan Armstrong, Group CEO, commented: “These results show a strong growth trajectory which is testament that our strategy of investing significantly in our people, facilities and unique solutions is clearly effective. With 100% of our profits reinvested into our business, we will continue to innovate and improve our wide range of services and products to ensure we provide the premium solutions our global client base relies on.

He continued: “These results are for our 2018-19 financial year and, since then, much has changed in our industry. In response to the COVID-19 pandemic, we continue to conduct our critical business operations across all our locations. The health and safety of our employees and our ability to ensure the delivery of medicines to patients is, and always has been, our top priority and we are committed to ensure this continues.”

ENDS

About Almac Group

The figures quoted in this announcement relate to the financial period 1 October 2018 to 30 September 2019 and does not include work relating to COVID-19 or other projects being carried out during the current 2019/2020 FY.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Welcomes Confirmation that Northern Ireland’s Pharmaceutical Industry will Maintain Regulatory Alignment with the EU Post-Brexit

evewallace — Thu, 04 Jun 2020 08:50:09 +0000

Move offers Almac clients unique, unfettered and flexible access to both the UK and European markets

Craigavon, N.I., 04 Jun 2020 – Northern Ireland-based Almac Group has welcomed confirmation from the EU’s medicines regulator, the EMA, that, post-Brexit, Northern Ireland will remain in regulatory alignment with the EU, acknowledging that EU laws, in respect of medicinal products, shall continue to apply in Northern Ireland. The UK Government has now also confirmed that this will be the case.

As a result, manufacturing and associated QP (Qualified Person) certification, for both clinical supplies and commercial product performed at Almac’s global HQ site in Craigavon, will continue to be recognised both by the UK and European regulatory agencies and allow products processed at its facilities seamless regulatory movement into both the EU and UK.

Due to the geographical location of its global headquarters in Craigavon, Northern Ireland, Almac Group is now in a uniquely advantageous position to offer its global client base unique, unfettered and flexible access to both the UK and European markets. This move provides customers the clarity, confidence and reassurance they have been seeking regarding continuity of supply to their patients throughout the transition period and beyond.

Alan Armstrong, CEO, Almac Group, commented: “This latest confirmation, coming from both the EU and the UK, is a welcome step and ensures our current and future clients can continue to receive an unfettered solution with exclusive access to both the EU and UK marketplace. Crucially, our unique location in Northern Ireland ensures we can provide uninterrupted service provision now, and into the future, maintaining our position as a global leader in the life sciences sector.”

This news comes three years after the Group established a bespoke facility in Dundalk, Ireland, which enabled Almac to guarantee immediate and seamless access to the EU, regardless of the final shape of Brexit. This proactive move provided welcome reassurance to its global clients at a time of uncertainty throughout the Brexit negotiations. This new confirmation around the NI protocol will offer clients even further reassurance around another of Almac’s facilities.

ENDS

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Almac Clinical Technologies Introduces SimplifyTM, an Advanced IRT Solution Enabling Faster Clinical Trials Start-up

evewallace — Mon, 01 Jun 2020 12:00:00 +0000

Developed using data from over 3,000 clinical trials, Simplify™ empowers trial sponsors and CROs to conduct patient randomization, site and drug supply management in half the time of traditional solutions

Souderton, PA – 1 Jun 2020– Almac Clinical Technologies, part of the Almac Group, today announced the availability of Simplify^TM, a next-generation Interactive Response Technology (IRT) solution that comes standard with an array of configurable functionality designed to accelerate the study start-up process with greater efficiency.

Simplify was designed for trial sponsors and CROs who need to quickly and efficiently stand up critical eClinical infrastructure with minimal effort or oversight. The new IRT solution offers a no-hassle, straightforward approach for deploying industry-leading IRT capabilities in half the time of traditional solutions.

In order to provide faster implementation time with the same level of high quality that Almac is known for, an extensive analysis of over 3,000 clinical trials that were previously supported with Almac IRT solutions was conducted for the purpose of identifying and standardizing the most commonly requested and critical IRT functions. As a result, Simplify offers trial sponsors and CROs a streamlined and consolidated deployment schedule that eliminates traditional bottlenecks typically associated with requirements gathering, customization specifications and prolonged periods of User Acceptance Testing.

Simplify is powered by state-of-the-art Almac IXRS^® 3 technology that is known for high performance and reliability. The solution also provides users with the experience and usability expected from a premium brand, yet at a significantly reduced cost.

“Simplify sets itself apart from other IRT alternatives by offering the flexibility to scale the scope of your solution to at any time. Explains Valarie Higgins, President & Managing Director of Almac Clinical Technologies. “This means that unplanned, or unexpected, protocol changes that require custom solutions can be swiftly implemented without requiring a major redesign, and are guided by our expert team of biostatistical, integration, design and support consultants. We’re very proud of our longstanding reputation for developing novel solutions in direct response to the pain points we have observed in the industry.”

In the current environment where time is of essence, Simplify has already demonstrated success through a recent collaboration with a top-10 multinational pharmaceutical company that needed to deploy an expedited clinical trial in support of COVID-19. As announced in April, together with Simplify and Almac Clinical Technologies, the trial sponsor was able to progress from award of the contract to patient enrolment in just seven days.

To learn more about how Almac can help to simplify your next clinical trial, please visit almacgroup.com/simplify.

ENDS

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Almac Group Supports Two COVID-19 Clinical Studies in Sub-Saharan Africa

davidkane — Thu, 28 May 2020 13:00:12 +0000

Grant awarded from the COVID-19 Therapeutics Accelerator, an Initiative by the Bill & Melinda Gates Foundation, Wellcome and Mastercard

Craigavon, N.I., 28 May 2020 – Almac Group, the global contract development and manufacturing organisation, has received a $288,000 grant to support a clinical study in Sub-Saharan Africa in efforts to find a treatment for Coronavirus. This was awarded from the COVID-19 Therapeutics Accelerator, an initiative by the Bill & Melinda Gates Foundation, Wellcome and Mastercard.

Almac Clinical Services is providing a full range of clinical trial solutions from protocol through to patient delivery, whilst Almac Sciences is providing analytical support, direct from its global headquarters in Craigavon, Northern Ireland. In an effort to expedite the drug development process, Almac Clinical Services has received the active drug and is providing over encapsulation services, manufacturing a placebo match, packaging and labelling the supplies to support this blinded clinical trial. Almac Sciences is conducting rigorous analytical and stability testing for the investigational drug.

Dr. Robert Dunlop, Managing Director and President, Almac Clinical Services commented. “This virus is threatening peoples’ lives and livelihoods and nowhere worse than in the poorer regions of the world. Almac’s global capabilities and expertise enables us to play our part and support efforts to find a vaccine and/or treatment for Coronavirus. We are delighted to be awarded this grant from the COVID-19 Therapeutics Accelerator and to be supporting these clinical studies in Sub-Saharan Africa.”

Almac Clinical Services will ship all supplies to the clinical site with onward management of logistics and distribution of quality drug for delivery safely to patients. This Covid-19 study is being led by an African Principal Investigator. In addition, Almac is supporting a second open label clinical study through the distribution of commercial packs to a pharmacy in South Africa. Due to its comprehensive range of innovative and flexible services, Almac was approached to support these urgent clinical studies by R&D Supply Chain Advisors, Brizzey LLC.

ENDS

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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InMed and Almac Group Developing Improved Cannabinoid Production Methods

davidkane — Tue, 05 May 2020 10:30:00 +0000

Vancouver, BC – May 5th, 2020 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (TSX:IN; OTCQX:IMLFF), a clinical-stage pharmaceutical company developing medications targeting diseases with high unmet medical need and leading the way in the clinical development of cannabinol (“CBN”), today announced that it is working with the Almac Group (UK) (“Almac”) on a proprietary approach to augment current biosynthesis-based methods for cannabinoid production.

Over the last several months, InMed and Almac have been engaged in developing a streamlined cannabinoid manufacturing process, specifically optimizing the upstream cannabinoid assembly processes as well as downstream purification, to achieve cost efficient, GMP-grade active pharmaceutical ingredients for prescription-based medications.

“InMed’s research and development teams have been working diligently in identifying an approach that integrates several existing pharmaceutical manufacturing processes to enable cannabinoid production,” said InMed’s Senior Vice President, Preclinical Research & Development, Dr. Eric Hsu. “An essential part of our effort has been drawing on the extensive experience and ‘best practice’ expertise of leading contract development and manufacturing organizations. Almac brings extensive knowledge and a successful track record to this effort, from early process development to commercial-scale manufacturing. We are very much looking forward to continuing our combined efforts in optimizing different aspects of the cannabinoid manufacturing process.”

Prof. Tom Moody, Almac’s VP of Technology Development and Commercialisation added, “Working with the InMed team on, what we all believe may become, a state-of-the-art approach to cannabinoid manufacturing has been an exciting challenge. Our companies continue to make steady progress in several areas across multi-disciplinary research including enzyme engineering, process design and development and downstream processing.”

About InMed: InMed Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of cannabinoid-based medications, initially focused on the therapeutic benefits of cannabinol (CBN) in diseases with high unmet medical need. The Company is dedicated to delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines. For more information, visit www.inmedpharma.com.

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TruSight Oncology Family Grows with Liquid Biopsy and High-Throughput Assay Additions

davidkane — Fri, 24 Apr 2020 17:30:00 +0000

Providing customers with a versatile, scalable, sample-to-report workflow

Craigavon, U.K., 24 April 2020 – Bringing comprehensive genomic profiling (CGP) one step closer to the standard of care in oncology, Illumina is now shipping TruSight™ Oncology 500 ctDNA (TSO 500 ctDNA), our first liquid biopsy solution for detecting cancer biomarkers, and TruSight Oncology 500 High-Throughput (TSO 500 HT), enabling high-throughput implementation by large labs with high-volume tissue sample needs. TSO 500 ctDNA and TSO 500 HT provide labs with the flexibility to run tissue or blood plasma samples on a single high-throughput platform, the NovaSeq™ 6000 Sequencing System. These two new additions join the TruSight Oncology 500 (TSO 500) family – the tissue-based version of the assay, which is optimized for both the NextSeq 550 and NextSeq 550Dx Systems. TruSight Oncology 500 products are currently intended for research use only (RUO).

TSO 500 ctDNA enables non-invasive, comprehensive genomic profiling of circulating tumor DNA (ctDNA) when tissue testing is not optimal, or to complement tissue-based testing. TSO 500 ctDNA is one of the first liquid biopsy assays to enable comprehensive genomic profiling that interrogates the sequence of 523 genes in key cancer-related pathways, including single-nucleotide variants (SNVs), Indels, copy-number variants (CNVs), fusions, microsatellite instability (MSI) and tumor mutational burden (TMB).

Optimized for the NovaSeq 6000, TSO 500 ctDNA offers both the economic value and the scale of sequencing needed to properly interrogate ctDNA at high levels of sensitivity and specificity. Complementing TSO 500 ctDNA on the NovaSeq 6000 is TSO 500 HT, providing large labs the ability to perform CGP analysis of up to 192 FFPE samples at a time, in a single NovaSeq sequencing run. Additionally, the two assays offer comprehensive coverage including a majority of the known and anticipated biomarkers associated with guidelines and clinical trials.

“We believe in the advancement of personalized medicine guided by molecular-based testing to improve patient outcomes,” said Margot P. Schoenborn, CEO of OmniSeq, Inc. “TSO 500 HT gives us the scalability to process a large number of samples every week, in that we can batch from 16 to 192 samples in a single run on the NovaSeq. Having the flexibility to run multiple flow cell options will enable us to optimize sequencing runs based on clinical volumes and flexibility to meet the turnaround time requirements of our customers.”

By offering solutions that independently interrogate both tissue and liquid biopsies on the NovaSeq 6000, Illumina’s TSO 500 portfolio enables a complete solution of in-house quality comprehensive genomic profiling assays, providing customers with:

Flexibility and efficiency to deploy the same oncology panel, on the same sequencing platform, regardless of sample type
Ability to run comparability of results in tissue and blood from a single individual, or across individuals
Scalability to meet high-throughput lab requirements

“Comprehensive genomic profiling on the DNA- and RNA- level will play an increasing role for cancer precision medicine,” said Professor Albrecht Stenzinger, MD, from the Institute of Pathology at University Hospital in Heidelberg, Germany. “There is a growing number of drug targets, as well as an emerging landscape of resistance mechanisms, that will make large panels, which I define as panels with more than 1 Megabase genomic footprint, not the exception, but the norm. High quality data with low TAT will be crucial in this context,” he concluded.

Offering an impressive sample-to-answer workflow, with a five-day turn-around time

Secondary analysis of large liquid biopsy CGP panels can be challenging. To address this issue, TSO 500 ctDNA utilizes the Illumina DRAGEN^TM (Dynamic Read Analysis for GENomics) Bio-IT Platform to provide accurate and ultra-rapid secondary analysis of sequencing data. TSO 500 ctDNA leverages the combination of the DRAGEN Bio-IT server hardware and DRAGEN TruSight Oncology 500 ctDNA Analysis Software to offer an accelerated, easy-to-implement, fully integrated set of bioinformatics algorithms to overcome ctDNA challenges, and ensure optimal assay performance. This is important because it provides robust and accelerated comprehensive variant calling, at very low limits of detection, in a single solution.

Dr. Steven Walker, Head of Product Development, Almac Diagnostic Services said: “This innovate product from Illumina will enable Almac to provide Pharmaceutical and Biotech companies with a new liquid biopsy option to support their translational research, clinical trials and CDx development. The assay, based on the TSO 500 platform, allows the mutational assessment of 523 genes from a single liquid biopsy sample. Integration of the Illumina DRAGEN™ Bio-IT platform into the workflow will help to significantly reduce the turnaround time for complex data analysis for our clients.

He continued: “Almac sees this product as a key component in our broad range of biomarker solutions. From the pharma or biotech perspective, this platform will enable biomarker discovery and testing from non-invasive samples, rather than typical tumor biopsy based methods which can be challenging. We believe this large panel and powerful analysis platform will enable our clients to effectively develop exciting new biomarkers for novel therapeutics.”

The TSO 500 menu, including TSO 500, TSO 500 ctDNA [WL1] and TSO 500 HT offer Pierian Dx’s streamlined tertiary interpretation and reporting, from their Clinical Genomics Workspace (CGW) platform. Powered by a comprehensive Clinical Genomics Knowledgebase, CGW gives customers the ability to identify and categorize pathogenic variants, and build a final annotated interpretation report. The combination of Illumina’s comprehensive tumor profiling assays coupled with DRAGEN and PierianDx’s variant interpretation and reporting solutions provides customers with a seamless and semi-automated workflow, from sample to final report.

Read Chief Medical Officer, Phil Febbo’s, perspective on the power and promise of liquid biopsies here. For more information on TSO 500 ctDNA and TSO 500 High-Throughput, click here.

###

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Achieves Zero Landfill Target

davidkane — Wed, 22 Apr 2020 12:58:43 +0000

Global organisation announces ground-breaking environment milestone just in time for Earth Day

Craigavon, U.K., 22 April 2020 – The global pharmaceutical company, Almac Group, is pleased to announce this Earth Day 2020 that the organisation has achieved a ground-breaking environmental milestone by becoming a zero waste to landfill organisation at its global Headquarter campus in Craigavon. This was achieved by diverting all waste from landfill sites thereby significantly reducing the associated greenhouse gas emissions.

To address the challenge of zero landfill, Almac identified a number of potential outlets for their wasted resources. Subsequently the company commenced a programme to educate key stakeholders about the materials that could be recycled or reused by charities and community organisations.

As a result, recycling and food waste bins were introduced across the Craigavon campus and its 3,500 employees based there encouraged to observe good waste management practices. All waste was either recycled, processed to produce biogas and fertiliser or burned to produce energy.

Wesley Best, Environment Manager at Almac Group, comments on the company’s environmental achievements: “As one of the world’s largest contract pharmaceutical development and manufacturing organisations we were becoming more aware of the environmental impact caused by the needless disposal of waste going to landfill. The process has been carefully orchestrated thanks to the assistance of local contractors, companies and charities, who have helped us achieve our zero-waste goal.

He added: “We are grateful to all our employees who have committed to the initiative and hope that we can lead by example as a company who can make effective steps to prevent landfill waste.”

###

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Clinical Technologies announces expedited support for COVID-19 Clinical Trials

evewallace — Tue, 07 Apr 2020 10:31:24 +0000

Expedited implementation of Interactive Response Technology (IRT) in support of pandemic research efforts

Souderton, PA, USA, 7 Apr 2020 – Almac Clinical Technologies, a member of the Almac Group, has today announced the expedited deployment and support of multiple Interactive Response Technology (IRT) solutions in support of COVID-19 treatments.

Several clinical trial sponsors have recently entrusted Almac in order to support expedited pathways to emergency clinical trials designed to investigate the efficacy of investigational medicinal products and commercially pre-approved medicinal products to reduce the impact of the novel COVID-19 coronavirus.

The result of these collaborations materialized in the form of fully-functioning IRT systems used for patient randomization and clinical trial material management that were designed, validated, and deployed in as little as one week.

As part of Almac’s ongoing commitment to innovation and providing a better IRT experience for clinical trial operations, a novel, expedited process was utilized to reduce the time requirements and input needed from trial sponsors – thereby ensuring the focus could remain on optimizing patient outcomes.

In one instance, the date for the first patient to be enrolled shifted, and Almac had to deliver the IRT system a day earlier than what had been initially planned. The client’s request was circulated among Almac teams on a Friday afternoon, and by Saturday, an array of IRT specialists had already established how they could deliver for the sponsor. The Almac team volunteered to work tirelessly on nights and weekends to be part of what they hope may lead to a scientific breakthrough.

Valarie Higgins, President and Managing Director, Almac Clinical Technologies commented: “In times such as these, Almac’s mission to Advance Human Health has never been more applicable. We stand committed in global solidarity – to do our part in reducing the burden and barriers involved in solving global challenges such as COVID-19 through clinical research. We hope to that our singular focus on the rapid delivery and support of Interactive Response Technology used in clinical trials will prove to be a catalyst in advancing the research and data acquisition efforts that are urgently needed. We stand ready and committed to supporting our biopharmaceutical partners through any means necessary.”

To find out more about Almac, visit here.

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Self-administered pain-killer saves patient time and NHS resources in accident and emergency departments

davidkane — Tue, 31 Mar 2020 14:21:45 +0000

Inhaled analgesic can save average patient 71 minutes for some common injuries compared to traditional therapies

Craigavon, N.I., Tuesday 31 March 2020 – An inhaled analgesic recently introduced to the UK can save more than one hour per appropriate procedure in hospital accident and emergency (A&E) departments on average – allowing more patients to be seen and potentially saving money for the NHS, a new study reveals.1

The drug, Penthrox▼ (methoxyflurane), has been widely used in Australia and New Zealand for many years, where it has been nicknamed “the Green Whistle” based on its appearance. However, it is used in fewer than half of UK A&E departments mainly due to staff unfamiliarity with the treatment.

Now, researchers from St Mary’s Hospital in London, part of Imperial College Healthcare NHS Trust, have found the drug, which is self-administered under the supervision of a trained professional, can save 71 minutes on average in treating some A&E patients, compared to usual pain-killing techniques, with the added benefit of saving up to 50% on the cost of treatment per patient depending on the type of trauma injury.1

The results come at a time when the NHS is facing exceptional pressure. They demonstrate how the use of Penthrox as a first-line analgesic for appropriate patients may free up resources including staff and equipment required to treat patients compared with standard treatments.

Over the course of six months, the researchers, supported by A&E Consultant Dr George Bailey, looked at length of stay in A&E for patients with moderate or severe trauma pain who received methoxyflurane compared with those who received standard care.1

There were particular gains for patients suffering from a dislocated shoulder, where methoxyflurane patients saved around three hours in treatment time.1

The study, published today in the journal Advances in Therapy, also looked at costs between the different treatments and concluded that methoxyflurane may save up to 50% on the cost of treatment per patient depending on the type of trauma injury.1 The researchers explained that Penthrox can negate the need for procedural sedation, which requires an intravenous line into the arm, a resus bed, which are often not immediately available, and also requires the time of three staff to carry out the procedure. By contrast, Penthrox could be administered in a chair or on a trolley and only required one or, sometimes two, staff members depending on the procedure, as Penthrox is self-administered by the patient.

The researchers commented “Long waiting times, slow discharge times and overcrowding are affecting almost every emergency department in the UK, and the situation does not show any signs of significant improvement at present.”

They concluded “This evaluation demonstrated that the early use of methoxyflurane can positively impact length of stay within emergency departments and provide effective pain relief for patients.”

Commenting on the findings, Dr George Bailey said: “During our evaluation the use of Penthrox was well received by our staff and patients. Being able to offer early fast acting pain relief is essential and we were pleased to find the additional benefit of reducing time patients spent in A&E compared to standard care.”

Penthrox consists of a green-coloured tube containing a fixed measure of methoxyflurane and can be self-administered by patients. It can provide up to 60 minutes of pain relief per treatment.2 As a single-use product that requires no canisters, additional breathing masks or tubes and is disposed of after patient use via a sealable plastic bag, it greatly minimises the potential of inadvertently spreading infection across a department or between buildings. It is marketed in the UK by the pharmaceutical company Galen.

Notes to editors

About Penthrox▼ (methoxyflurane)
Penthrox (methoxyflurane) is a rapidly-acting inhaled analgesic agent which is self-administered under the supervision of a person trained in its administration.2 It has been proven to rapidly provide effective analgesia3,4 and potentially reduce patient length of stay in hospital settings.1

Methoxyﬂurane has been used extensively in Australia and New Zealand as emergency analgesia for more than 40 years and is licensed in a number of European countries for the emergency relief of moderate-to-severe pain associated with trauma in conscious adult patients.2

About Galen
Established in 1968, Galen is a privately owned pharmaceutical sales and marketing company, headquartered in Craigavon (Northern Ireland), with products in therapy areas including gastroenterology, pain management and dermatology.

About Almac Group
Galen is a member of the Almac Group. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across, and beyond, the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Almac’s innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture, product development and marketing.

Almac has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

For further information please visit almacgroup.com.

References

Young L, Bailey G, McKinley J. Service evaluation of methoxyflurane versus standard care for overall management of patients with pain due to injury. Adv Ther 2020.
Penthrox (methoxyflurane) Inhalation Product Information. December 2018 https://www.medicines.org.uk/emc/product/1939/smpc.
Coffey F, Wright J, Hartshorn S et al. STOP!: a randomised, double-blind, placebo-controlled study of the efficacy and safety of methoxyflurane for the treatment of acute pain. Emerg Med J 2014; 31(8):613–618. https://doi.org/10.1136/emermed-2013-202909.
Mercadante S, Voza A, Serra S, et al. Analgesic Efficacy, Practicality and Safety of Inhaled Methoxyflurane Versus Standard Analgesic Treatment for Acute Trauma Pain in the Emergency Setting: A Randomised, Open-Label, Active-Controlled, Multicentre Trial in Italy (MEDITA). Adv Ther 2019; 36(11):3030-3046.

MAT-PEN-UK-000244 Date of Preparation: March 202

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Call for entries for the Dr John Hinds Scholarship

admin — Tue, 03 Mar 2020 14:53:14 +0000

Craigavon, N.I., 3 Mar 2020 – The College of Paramedics, in association with Galen the privately owned pharmaceutical sales and marketing company, is calling on all levels of pre-hospital responders on the island of Ireland, to take part in this exciting opportunity to win a place at the much coveted Anaesthesia Trauma and Critical Care (ATACC) course, widely accepted as the most advanced trauma course currently available across the globe.

This Scholarship is presented in memory of the late Dr John Hinds, who was held in high regard as an inspirational leader by paramedics and emergency medical technicians and indeed by anyone with an interest in pre-hospital care within Ireland. He selflessly gave a huge amount of his own time to educating and supporting paramedics and ambulance staff throughout the Island of Ireland; consequently, a scholarship for those colleagues is a fitting and practical way to preserve the memory of such a well-respected colleague and medical professional.

Entrants are required to write a case study, written to protect patient confidentiality, using original text, and with all appropriate references included. It must be countersigned by a paramedic colleague who is prepared to confirm that your submission is a genuine case study. Submissions should be 750–1,000 words, excluding references and appendices.

The recipient of the Scholarship will be funded to attend an ATACC course in the UK, in addition to associated travel costs.

Dr Dennise Broderick, Galen’s Managing Directory & President, stated “This award provides a unique opportunity for healthcare professionals to advance their expertise and gain access to a highly coveted training programme.

She added, “Dr Hinds was an incredibly inspirational individual who dedicated his life to helping others and Galen is therefore proud to support this annual scholarship programme in his honour.”

As a condition of the award, the recipient will be required to submit their case study for publication in Paramedic INSIGHT, along with a follow-up article that describes the experience attending the ATACC course.

Submissions must be made using the Dr John Hinds Scholarship Award Entry Form – link and submitted via email to awards@collegeofparamedics.co.uk. The College Honours and Awards Committee will then select the winning piece.

Submissions should be sent to awards@collegeofparamedics.co.uk and must be received by 1200hrs on 6th April 2020.

The award will be presented to the recipient on 13th May 2020 at the College of Paramedics Awards ceremony at the Hilton Birmingham Metropole, Birmingham.

2019 recipient, David Murtagh, commented “I was honoured to be selected as the inaugural recipient of the Dr John Hinds Scholarship. The Anaesthesia Trauma & Critical Care (ATACC) course offered three days of immersive, high-fidelity simulations involving wrecked cars/trains/buildings, local trauma units and major trauma centres. These were interspersed with practical skills stations and up-to-date relevant lectures, all delivered by a large and expert international faculty. The training I underwent highlighted the standard of trauma care we should be delivering, not just within a major trauma-centre setting, but also throughout our local emergency departments and in our communities.”

David is a Paramedic registered with the Pre-Hospital Emergency Care Council in the Republic of Ireland and has been working for the National Ambulance Service for three years. He is also an experienced mountain and cave rescue volunteer.

Notes to editors

About Galen

As a subsidiary of Galen Limited, Galen US also has a growing presence in select conditions such as those requiring topical anaesthesia. The company plans to continue expanding its portfolio with selected specialty products on an international basis. By combining innovation in product development with competitive pricing, Galen aims to work in partnership with healthcare professionals and patients to create real, long-term value. Visit: www.galen-pharma.com

About Almac Group

For further information please visit almacgroup.com.

About The ATACC Group

For further information please visit https://www.ataccgroup.com/

References

Galen. PKU Easy Microtabs datasheet.
MacDonald A, Smith A, de Silva S, et al. The personal burden for caregivers of children with phenylketonuria: A cross-sectional study investigating time burden and costs in the UK. Molecular Genetics and Metabolism Reports 2016;9:1-5.
NHS. Phenylketonuria. Available at: https://www.nhs.uk/conditions/phenylketonuria/.
Ford S, O’Driscoll M, MacDonald A. Living with Phenylketonuria: Lessons from the PKU
community. Molecular Genetics and Metabolism Reports 2018;17:57–63.
Giovannini M et al. (2014) Randomized Controlled Trial of a Protein Substitute with Prolonged Release on the Protein Status of Children with Phenylketonuria, Journal of the American College of Nutrition, 33:2, 103-110, DOI:10.1080/07315724.2013.857281

MAT-POA-UK-000003

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Almac Clinical Services’ Just in Time Manufacturing Operations Pass EU Regulatory Inspection

admin — Tue, 18 Feb 2020 09:00:32 +0000

Craigavon, N.I., 18 February 2020 – Almac Clinical Services, a member of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, today announced its Just in Time Manufacturing (JTM) processes have received GMP compliance certification from Ireland’s Health Products Regulatory Authority (HPRA). This assessment occurred as part of a recent inspection at the Group’s European campus in Dundalk, Ireland.

Almac’s innovative JTM service, Almac Adapt™ was launched globally in June 2019 and enables full late stage customisation of clinical supplies by postponing packaging and labelling until the site or patient’s need arises.

The HPRA inspected Almac’s JTM suites and associated processes at the facility, which are capable of servicing clinical trials of all temperature ranges, from ambient through to ultra-low. No deviations or concerns were noted and the highly respected body subsequently updated Almac’s manufacturing authorisation (MA) to include secondary packaging capabilities.

Almac has invested more than £4.4m in the development of the JTM service Almac Adapt and facilities globally including its sites in Craigavon (UK), Dundalk (Ireland), Souderton (Pennsylvania), Durham (North Carolina) and Singapore to meet the needs of the changing clinical trial landscape and reducing timelines, wastage and mitigating product shortages associated with conducting clinical trials.

Natalie Balanovsky, JIT, Manufacturing Solutions Manager, Almac Clinical Services commented:

“This successful inspection is another significant milestone for Almac Clinical Services and, in particular, Almac Adapt™. It positively reflects our commitment to supporting our clients with their global clinical supply operations. Receiving the official HPRA certification is testament to the quality and skill of our employees who are a key part of our ongoing strategy to meet both ongoing market and patient needs.”

#Ends#

About Almac Group

A unique culture delivering exceptional solutions

We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Clinical Services’ Just in Time Manufacturing Operations Pass EU Regulatory Inspection appeared first on Almac.

Launch of innovative medical food provides a palatable new option for people diagnosed with rare metabolic disorder in the UK

admin — Wed, 12 Feb 2020 10:00:24 +0000

Launch of innovative medical food provides a palatable new option for people diagnosed with rare metabolic disorder in the UK

Craigavon, N.I., 13 Feb 2020 – An innovative medical food (food for special medical purpose) for people living with the rare, inherited metabolic disorder, phenylketonuria – or PKU as it is known for short – has been launched today in the UK. PKU EASY Microtabs provides a palatable alternative to other protein substitutes on the market, to help patients aged 8 and above manage the incurable condition and consume the protein they need each day.¹

Approximately 70 babies each year are born with PKU in the UK,² an inherited disorder which prevents the body from breaking down the proteins in foods to amino acids and if unmanaged, can lead to brain damage.³ Most patients in the UK are diagnosed at birth via newborn blood spot screening, also known as the heel-prick test, and are immediately started on treatment to reduce the risk of serious complications.³ Central to this is a lifelong, restrictive diet to limit the intake of one of the amino acids, phenylalanine, found in natural high-protein foods such as meat, fish, eggs and nuts. This is replaced with specially-designed medical foods to support the body’s everyday functions.^2,3

However, results from a 2018 survey of patients and caregivers in the UK found that the unpleasantness of available protein substitutes was one of the top three issues affecting both children and adults’ ability to follow their prescribed diet.⁴ PKU Easy Microtabs are small, innovative tablets with two distinct coatings that have been designed to overcome this challenge. The first delivers a palatable taste experience and prevents the tablet from dissolving before it hits the stomach, minimising acid reflux and bad breath; the second enables a slow release of amino acids into the body.⁵

“There’s no getting away from the fact that people living with PKU rely heavily on medical foods to supplement their diet in order to get the level of protein needed for good health. Yet we know from the community that many of the available options have an off-putting smell, taste bad and leave the patient with bad breath because of how they are digested. Today’s launch gives UK patients a more pleasant choice that other countries have already enjoyed the benefit of for years.” explained Simon Lawrence, Commercial Director of Galen Nordics (formerly known as POA Pharma).

PKU Easy Microtabs was first launched by POA Pharma across Scandinavia in 2011, but until now, was not available to UK patients via the NHS. Last month, Galen announced the completion of its acquisition and takeover of POA Pharma. Alongside its wider product portfolio, the move was intended to expand access to the company’s innovative nutritional therapies for people with PKU.

Dr Dennise Broderick, President & Managing Director Galen said: “Within one month of the completion of our acquisition of POA Pharma we are delighted to be able to bring this important new dietary management option to the 6,000 plus patients living with PKU across the UK. This is a condition that patients have to think about every single day of their lives to ensure they have the right levels of protein to function correctly.

Portability, taste and digestion of medical foods are all important considerations that we are proud to have addressed for the community with our novel microtabs.”

Notes to editors

About PKU Easy Microtabs¹

PKU Easy Microtabs are small coated microtabs containing non-Phe amino acids, for the dietary management of PKU for patients aged 8 and above. They are swallowed with liquid or eaten with cold foods, such as jam or fruit purée.

The dose is established in cooperation with a dietician and it should only be used under medical supervision. It is not meant to be the only source of nutrition.

About Galen

As a subsidiary of Galen Limited, Galen US also has a growing presence in select conditions such as those requiring topical anaesthesia. The company plans to continue expanding its portfolio with selected specialty products on an international basis. By combining innovation in product development with competitive pricing, Galen aims to work in partnership with healthcare professionals and patients to create real, long-term value. Visit: www.galen-pharma.com

About Almac Group

For further information please visit almacgroup.com.

References

PKU Easy Microtabs datasheet.
MacDonald A, Smith A, de Silva S, et al. The personal burden for caregivers of children with phenylketonuria: A cross-sectional study investigating time burden and costs in the UK. Molecular Genetics and Metabolism Reports 2016;9:1-5.
Phenylketonuria. Available at: https://www.nhs.uk/conditions/phenylketonuria/.
Ford S, O’Driscoll M, MacDonald A. Living with Phenylketonuria: Lessons from the PKU community. Molecular Genetics and Metabolism Reports 2018;17:57–63.
Giovannini M et al. (2014) Randomized Controlled Trial of a Protein Substitute with Prolonged Release on the Protein Status of Children with Phenylketonuria, Journal of the American College of Nutrition, 33:2, 103-110, DOI:1080/07315724.2013.857281

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Almac Group launches enhanced Label Approval Solution (LAS)

admin — Thu, 06 Feb 2020 16:21:49 +0000

Delivering an efficient, seamless process for clinical labels from protocol to print

Craigavon, U.K., 6 Feb 2020 – Almac Clinical Services, a member of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, has today announced the launch of its enhanced Label Approval Solution (LAS) – a fully compliant and validated system providing sponsors with an end-to-end solution to manage their clinical labels more effectively from Protocol to Print.

As part of its customer experience initiative with an ongoing focus to provide customers with flexible, innovative and efficient processes, Almac’s enhanced LAS will enable sponsors to have access to the latest online technology thereby streamlining review, mark up and approval of label proofs, master text production and label text localization. The solution optimises all clinical label development processes, with dedicated project management teams and supporting centralised technology (LAS), to deliver a seamless process for sponsors.

In an era of change and digitalisation, labels are one clinical supply item that often defines the critical path in the supply chain. These emerging technologies are reshaping the clinical trial landscape and with this brings a wealth of opportunities to use technology to increase R&D productivity and provide the information that sponsors need to optimise decision-making.

Almac is an experienced provider of clinical labelling, printing millions of global labels on a monthly basis. By addressing the disconnects that have become synonymous with traditional labelling processes, Almac’s enhanced Label Approval Solution offers sponsors a single secure platform for Investigational Medicinal Product (IMP) label development, management and tracking while mitigating risk through in-depth project planning. Bringing together text generation, regulatory review, translation, proof generation and proof approval within a standalone workspace enables sponsors to benefit from fully validated end-to-end label development with real-time visibility, control and traceability of label text.

Nathan Kohner, Almac Clinical Services’ Label Service Solutions Manager, commented: “We understand our customer’s challenges and we have the resources, experience and expertise to manage the range of labelling scenarios they may face. Our enhanced Label Approval Solution provides sponsors with an end-to-end review process that ensures labels meet the needs of clinical sites and patients. By designing labels based on clinical knowledge, unique and compliant design strategies can be developed to deliver sponsor-specific solutions that suit the needs of an individual whilst mitigating risks, optimising workflow processes, saving time and money and safeguarding the patient. I am delighted to launch this solution that further cements our commitment to the advancement of human health.”

To learn more about Almac’s enhanced LAS, download our Brochure and Case Study.

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About Almac Group

A unique culture delivering exceptional solutions

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Almac Group to Host West Coast Lunch and Learn Workshop Series on Adaptable Clinical Supply Chain Strategies for Biologics

admin — Tue, 28 Jan 2020 14:00:30 +0000

Open invitation to the biopharma industry to share insights

Souderton, PA, U.S., 28 January 2020 – Almac Clinical Services, part of the global contract pharmaceutical development and manufacturing organization the Almac Group, is delighted to invite participants from the Pharma & Biotech industries to join its West Coast Lunch and Learn Workshop Series.

Almac’s subject matter experts, Natalie Balanovsky, Just In Time Manufacturing Solutions Manager, and Bryan Thompson, Production Manager, will host the exclusive masterclass titled, “Ensuring Supply Chain Flexibility and Viability for Biologics”.

The complementary workshops will be held on:

February 25 in San Diego, CA
February 26 in San Francisco, CA
February 27 in Seattle, WA

Natalie comments on the upcoming lunch and learn:

“These sessions will provide attendees with a thorough understanding of how an agile clinical supply chain will decrease waste, increase product availability, and effectively manage limited stability profiles to meet the specific needs of biologic trials. As the number of biologic and biosimilar type drugs being trialled continues to increase, Almac understands that time is precious for our sponsors and we have crafted this educational session with that in mind.”

As industry leading experts with over 30 years’ experience in clinical trial supply, Almac hopes that the information presented during this complimentary event, as well as future workshops, will help guide industry professionals throughout their clinical supply journey.

To find out more and to sign up click here.

About Almac Group
A unique culture delivering exceptional solutions.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac and Pfizer celebrate success of patient-led clinical supply model in gene therapy trial

admin — Wed, 22 Jan 2020 14:30:11 +0000

Craigavon, N.I., 22 January 2020 – Almac Clinical Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, has released a case study detailing how the organisation’s successful LEAN packaging process supported Pfizer’s urgent mission to dose a child diagnosed with Duchenne Muscular Dystrophy (DMD), with a life enhancing gene therapy.

Pfizer has made a significant effort to extend the life expectancy and improve the quality of life for patients with Duchenne Muscular Dystrophy (DMD), one of nine types of muscular dystrophy. In 2017, Pfizer’s solution— a new mini-dystrophin gene therapy drug (PF-06939926)— was granted Orphan Drug and Paediatric Rare Disease Designations by the FDA and Orphan Medical Product Designation by the European Medicines Agency. The following year, Pfizer embarked upon a Phase Ib, US-based clinical study to assess the safety, tolerability and efficacy of the product.

The case study released by Almac is centred on Pfizer’s urgent need to dose the trial’s first paediatric patient an exact quantity of the mini-dystrophin gene therapy in two weeks, three times less than the standard timeframe. In response, Almac developed a bespoke strategy based on the organisation’s industry-leading LEAN packaging and labelling principals, that resulted in the patient being dosed in just twelve days, an unprecedented four weeks quicker than the standard.

Natalie Balanovsky, JIT Manufacturing Solutions Manager at Almac comments “We are delighted to present our efforts alongside Pfizer and share insights from our collaboration through this case study. As clinical trials become more complex with the rise of biologics, we believe that the benefits associated with adapting a patient-centric approach to supply strategy are significant and we are therefore pleased to share our successes with the industry.”

The full case study can be downloaded here: https://www.almacgroup.com/clinical-services/case-study-lean-packaging-process-supports-pfizers-urgent-mission-to-dose-child-with-life-enhancing-gene-therapy/

About Almac Group

‘Partnering to Advance Human Health’

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com

almacgroup.com

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Northern Ireland’s STEM Excellence Celebrated

admin — Fri, 10 Jan 2020 09:00:37 +0000

Hans Sloane & Sloane McClay Award nominations reach all time high

Craigavon, N.I., 10 Jan 2020 – Nine top Northern Ireland science students, and their schools, have been recognised for their outstanding excellence through the Hans Sloane Medal and the Sloane McClay Awards.

The Hans Sloane Memorial Fund Trust, in partnership with National Museums NI, was established in 1960 to commemorate the life and work of the celebrated Killyleagh physician, scientist and collector. In 2017, and in collaboration with Almac Group, the Hans Sloane Trustees launched the Sloane McClay award in memory of Sir Allen McClay, the late Founder and Chairman of global contract pharmaceutical development and manufacturing organisation, the Almac Group.

The Hans Sloane Medal is awarded to the top student obtaining the highest combined marks in ‘A’ level biology, chemistry and physics. To augment the Hans Sloane Medal, the Sloane McClay (Triple) Award is presented to the top student obtaining the highest combined marks in GCSE biology, chemistry, physics and maths. This was enhanced in September 2019 with the addition of a new Sloane McClay (Double) Award offered to students studying double award science and maths.

In September, school principals from across the province were invited to nominate their top performing ‘A’ level and GCSE science & maths students. This year saw a record number of nominations with 142 individuals put forward for consideration for all three awards.

Winning students, and their families, attended a prestigious awards ceremony in the Ulster Museum on Thursday 9th January 2020, to recognise their individual achievements. Professor Tom Moody, VP Technology Development and Commercialisation, Almac Group, delivered an engaging lecture entitled “Science of our DNA” before presenting the individual and school awards.

The winner of the 2019 Hans Sloane Medal, certificate and cheque for £500 was Claire Whiteside. Her former school, Strathearn, Belfast, also received a Hans Sloane Medal and framed certificate as recognition for excellence in teaching. Claire is now studying Medicine at Queen’s University, Belfast.

Second place certificate and a cheque for £300 was presented to Aoibheann Quail from St. Louis Grammar School, Kilkeel. Sarah O’Callaghan from Thornhill College, Derry received a certificate and £150 cheque for third place.

The Sloane McClay (Triple) award first prize went to Francesca Wilson from Our Lady & St. Patrick’s College, Knock while the newly introduced Sloane McClay (Double) top award was presented to Larne Grammar School’s Isaac Holst. Francesca and Isaac received the Sloane McClay trophy, certificate and cheque for £250 each while their respective schools received a replica trophy and framed certificates to celebrate their teaching excellence.

Katie House from Foyle College (Triple Award Science and Maths) and Conor Gallagher (Double Award Science and Maths) at St. Columb’s College received 2^nd prize for their outstanding achievements at GCSE level. They were presented with a cheque for £150 and a certificate.

Third prize for the Triple award was presented to James Craig from Ballymena Academy and the accompanying Double award went to Seadhna Campbell from St. Patrick’s Academy, Dungannon. Each received a £50 cheque and a certificate.

All winning students also have the opportunity to carry out structured, informative and valuable work experience at Almac’s facilities in Northern Ireland offering them a chance to see first-hand what it is like to work in a leading global pharmaceutical contract manufacturing and development organisation.

Tom commented: “As a business employing over 5,600 individuals globally, our ongoing success depends on the talent and skills of our most important asset, our people, it is therefore crucial that we continue to invest in the next generation. Almac is strongly committed to recognising and rewarding achievements in STEM and our ongoing partnership with the Hans Sloane Trust is the perfect platform which enables us to do just that. I would like to congratulate all of today’s worthy recipients of the Hans Sloane medals and the Sloane McClay awards and wish them every success for their future.”

Dr Sally Montgomery, Chairman Hans Sloane Memorial Fund, commented: ‘The achievements of this year’s nominations have been exceptional and is testament to the teachers’ and students’ ability and hard work. We would like to extend our congratulations to all the students nominated this year. The partnership with Almac and the National Museums ensures that we continue to highlight the importance of STEM to the wonderful achievements of these students.’

To find out more about the Hans Sloane and Sloane McClay awards, visit almacgroup.com/sloanemcclay.

ENDS

About Sir Hans Sloane

The Hans Sloane (Memorial Fund) Trust, in partnership with National Museums NI, was established in 1960 to commemorate the life and work of the notable Killyleagh surgeon and collector, Sir Hans Sloane (1660–1753). Sloane promoted inoculation against smallpox, the use of quinine (a treatment for malaria) and the health-giving properties of drinking chocolate mixed with milk. Sloane’s collection became the foundation of the British Museum.

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com

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Galen, an Almac Company, announces Completion of Multi-Million Pound POA Pharma Acquisition

admin — Wed, 08 Jan 2020 05:00:46 +0000

Move adds substantial new therapeutic areas and territories to Galen’s reach

Craigavon, N.I., 8 Jan 2020 – Galen, the privately owned global pharmaceutical sales and marketing company, today announced the completion of a multi-million pound acquisition and takeover of boutique healthcare company, POA Pharma. The move enables Galen to significantly expand its global reach and product portfolio in exciting new therapy areas, such as rare metabolic disease.

Headquartered in Sweden, with additional facilities located across the Nordic region and North America, POA Pharma currently represents 16 producers from 10 countries and retains a strong portfolio of products and an extensive network worldwide. Galen first signed a distribution agreement with POA Pharma in April 2016, allowing the company to market and sell POA Pharma’s metabolic product portfolio in the UK and Ireland. The acquisition is an extremely significant new phase of Galen’s growth, as it extends its global footprint into the Nordic territory and Northern Europe.

As part of the takeover, Simon Lawrence, who has held various senior management positions with Galen over 33 years, has been appointed Commercial Director – Nordics and will be based at the POA facility in Copenhagen. He will oversee operations in the region and grow the team to reflect demand in line with the global Galen strategy.

Simon Lawrence commented: “Galen’s long-heritage and expertise in delivering valued medicines to the people that need them most, coupled with POA Pharma’s important portfolio, means we now have the opportunity to improve the lives of more people affected by a variety of diseases on a truly global scale. Particularly for the underserved, rare, phenylketonuria (PKU) population, who have limited treatment options available to them, today’s completion is a welcome step towards better access to life-saving nutritional therapies across Galen’s extensive distribution network and beyond.”

Dr Dennise Broderick, President & Managing Director Galen added: “This acquisition is highly complementary to our established business and marks a key milestone in our strategic global growth plans. The founders of POA have created a highly successful business and we look forward to incorporating and growing the reputable company further as part of the Galen organisation. This acquisition will enable Galen to offer a wider range of products to our customers, healthcare professionals and patients around the world.”

Notes to editors

About POA

POA Pharma is a market oriented Boutique Healthcare Company present in 9 competence areas with offices in Denmark, Finland, Norway, Sweden and US. The home market is the Nordic countries were POA represents 16 pharmaceutical producers from 10 countries. Our export is based on POA proprietary products, classified as food for specific medical purposes, products that are sold in more than 40 countries. www.poapharma.com

About Galen

Established in 1968, Galen is a privately owned pharmaceutical sales and marketing company, headquartered in Craigavon (Northern Ireland), with products in therapy areas including gastroenterology, urology, female health, pain management and mental health.

As a subsidiary of Galen Limited, Galen US also has a growing presence in select conditions requiring topical anaesthesia and Central Nervous System disorders. The company plans to continue expanding its portfolio with selected specialty products on an international basis. By combining innovation in product development with competitive pricing, Galen aims to work in partnership with healthcare professionals and patients to create real, long-term value. Visit: www.galen-pharma.com

About Almac Group

For further information please visit almacgroup.com.

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Almac Group and Exostar Collaborate to offer Better IRT Experience

admin — Thu, 12 Dec 2019 15:00:08 +0000

Standardize integration and frictionless identity management integration for BioPharma

Souderton, PA, USA, 12 Dec 2019 – Almac Clinical Technologies, a member of the Almac Group, has today announced the launch of a standardized, operationally-proven integration between its Interactive Response Technology (IRT) platform – IXRS® 3 and Exostar’s Identity and Access Management Platform.

The two global companies first announced a pilot partnership in December 2016 to demonstrate a proof-of-concept for eClinical application users to benefit from Exostar’s industry-leading Single Sign-On (SSO) expediency and enhanced security.

This latest technological advance will enable users of Almac Clinical Technologies’ Interactive Response Technology (IRT) to harness Exostar’s industry-leading credentialing, federation, and web-based Single Sign-On (SSO) capabilities to seamlessly and securely log in to Almac’s IXRS® 3 with credentials provided to each user by any member of the Exostar Life Sciences Community – which includes Trial Sponsors, Contract Research Organizations (CROs), cloud application providers, and others. Half of the world’s 20 largest pharmaceutical companies and nearly 15,000 industry organizations actively participate in the Exostar Life Sciences Community.

In addition, the collaboration with Exostar allows Almac to further its mission of enhancing the patient experience. The upgraded identity management capabilities within IXRS® 3 created as a result of the integration eliminate a major burden on trial sites, and enable them to focus more time and energy on patient care.

Valarie Higgins, President and Managing Director, Almac Clinical Technologies commented: “I’m delighted to further expand the capabilities of the IXRS® 3 solution and help broaden the ecosystem created by Exostar’s identity management platform and Transcelerate’s Shared investigator platform. These enhancements help to further our mission of creating a better IRT experience by reducing the burden on investigators and their teams, and leaving them with more time to spend with their patients.”

Kenny Kong, Director of Life Sciences & Health IT for Exostar added: “The clinical trials experience is going digital with the eClinical revolution, making ease of secure access a top priority. Sites need on-demand access to sponsor applications without the burden and vulnerability of juggling unique logins and credentials for each sponsor. Sponsors must quickly activate their sites and empower them with the tools they need to advance their studies. All parties require an identity and access management experience that’s simple, straightforward, and secure. The Almac/Exostar integration enables IXRS® 3 users to realize those benefits.”

If you’re interested in learning more about this collaboration and how it can support your clinical trial, Almac Clinical Technologies and Exostar will be co-presenting at the SCOPE Summit for Clinical Ops Executives from 18^th to 21 February in Orlando, Fl.

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

About Exostar

The leader in trusted, secure business collaboration in aerospace and defense, life sciences, and healthcare.

Exostar’s cloud-based platforms create exclusive communities within highly-regulated industries where organizations securely collaborate, share information, and operate compliantly. Within these communities, we build trust. More than 135,000 Aerospace and Defense organizations and agencies in over 150 countries trust Exostar to strengthen security, reduce expenditures, raise productivity, and help them achieve their missions. Ten of the top twenty global biopharmaceutical companies rely on Exostar to help them speed new medicines and therapies to market. Exostar is a Gartner Cool Vendor. For more information, please visit www.exostar.com.

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Almac Group’s Comprehensive STEM Programme Wins “Innovation in Sponsorship” Award

admin — Fri, 06 Dec 2019 14:01:56 +0000

Craigavon, N.I., 6 December 2019 –Almac Group, a global contract development and manufacturing organisation, is delighted to announce it has won the “Innovation in Sponsorship” award during this year’s Irish Sponsorship Awards ceremony in Dublin.

This award, given annually, recognises “a distinct new method or unique approach to a sponsorship activation, partnership or initiative”. Almac Group was awarded this honour for the organisation’s unique and innovative £1 million sponsorship agreement with W5, the interactive discovery centre in Belfast. The partnership, a first of its kind in Ireland, has resulted in a comprehensive STEM learning programme based at W5 that aims to improve access to STEM education and promote exciting career possibilities available through pursuing STEM subjects.

As a business employing over 5,600 individuals globally, Almac’s success depends on the talent and skills of its most important asset— its people. Understanding that it is therefore critical to engage as many pupils as possible to cultivate future talent, a partnership with W5 was launched in 2018 to showcase the organisation and greatly expand access to STEM programming to students, teachers and parents throughout Ireland.

From its onset, this included the construction of an interactive, bespoke physical exhibition for W5’s, ‘Med-Lab,” which utilises 3D technology to transport visitors into Almac’s laboratories and production environments. Through immersion into Almac’s business, visitors learn about the different stages in the medicine-making process that the organisation supports globally.

To further the impact of its exhibit, Almac’s sponsorship also included the launch of a STEM Pathway® Programme at W5. The programme, which began in October 2019, includes a series of unique, exciting and interactive workshops at W5 for post-primary schools. These events, tailored for each of the Key Stages from Year 8-14, provide students and teachers with the opportunity to speak with Almac staff, participate in practical demonstrations and get involved in hands-on activities.

Commenting, Kevin Reid, VP Global Marketing Almac Group said, “Through our unique sponsorship agreement with W5, Almac’s capability to fulfil its mission to reach, educate and engage pupils, parents and teachers from all over Ireland is greatly enhanced. Through sponsorship of Med-Lab and creation of a bespoke exhibit and associated education programme, Almac has built a distinctly hands-on, exciting method for pupils to learn about their health and pharmaceutical development, as well as a sneak peek into the operations occurring right at the heart of Almac, one of Northern Ireland’s largest employers.”

Since launching in 2012, the Irish Sponsorship awards have recognised industry leaders who leverage the sponsorship medium as a key strategic marketing channel through which to deliver business and organisational success. The winners were revealed at a Gala Awards dinner on 5 December at Croke Park, Dublin where Dr Frances Weldon, Almac Group’s STEM Outreach Manager received the award.

About Almac Group

‘Partnering to Advance Human Health’

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com

almacgroup.com

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Almac Group Hosts Internationally Recognised Chemistry Forum in Belfast

admin — Fri, 01 Nov 2019 07:45:17 +0000

Newly coined Nordic-Irish Process Chemistry Conference Scheduled in May 2020

Craigavon, N.I., 01 November 2019 – Almac Sciences, a member of the Almac Group, is delighted to announce that the 2020 Nordic Process Chemistry Forum, an internationally recognised forum for leaders in chemistry, will be held in Belfast, Northern Ireland for the very first time in the forum’s history. Traditionally hosted by Nordic-based companies, this move has resulted in the forum being renamed to the Nordic-Irish Process Chemistry Forum in advance of the event.

As a leader in process chemistry and R&D, Almac Sciences will serve as the host during the forum in May. The Nordic Process Chemistry Forum has a long history of attracting some of the most respected and innovative speakers in the world of chemistry, and the Belfast event will be the 9th forum in an unbroken chain of biannual events.

Since the event was founded in 2004, the main driver of the forum has been to to bring scientists together who are involved in the design and scale up of chemical processes. The event facilitates networking, addresses pertinent chemical challenges, and fosters idea sharing and hosts new chemical trends. The upcoming event in Belfast is no exception— a fantastic line-up of industrial and academic speakers has been secured for this event, covering a range of subjects within the process chemistry field. A dedicated website has been created for this event (see below) and registration is now open with opportunities for participation.

Professor Tom Moody, VP Technology Development & Commercialisation at Almac & Arran Chemical Company commented, “We have established excellent relationships with the Nordic Process Chemistry industry and are delighted to be entrusted to host this event in Northern Ireland. Almac knows, first-hand, of the rich chemistry expertise and innovative research taking place among industry and academia across theEU and our own island of Ireland and we are excited to showcase this at the event. We look forward to hosting our guests in Belfast where chemistry will be brought to life.”

Professor Hans-Jurgen Federsel, Founder of the Nordics forum, commented, “The basic idea behind starting the Nordic Process Chemistry Forum was the feeling that this part of the world was in dire need of a meeting ground where chemists, notably active in an industrial setting, could meet biannually and share top scientific and technical achievements. I’m personally very happy that my friends at Almac took on the task of organizing the 9^th consecutive event of this unbroken series and that we for the first time will be located outside the realm of the original Nordic countries.”

The Nordic Irish Process Chemistry Forum will be held from 12 – 14 May 2020 at the Titanic Quarter, Belfast, Northern Ireland. Visit the dedicated website here to register and download the agenda.

#END#

About Almac Group
A unique culture delivering exceptional solutions

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with our latest news, follow us on Twitter and LinkedIn

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Almac Group £35 million Brexit Solution Complete

admin — Mon, 21 Oct 2019 08:22:42 +0000

EU distribution centre attains successful HPRA inspection

Craigavon, N.I., 21 Oct 2019 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced the completion of the final phase of its £35 million custom-built European Campus in Dundalk, County Louth, Ireland. This site provides uninterrupted service provision to its global clients regardless of the outcome of the Brexit negotiations.

Almac first announced acquisition of its new European Campus in early 2017 as part of its global expansion strategy creating over 100 new jobs.

Twelve months later, the company announced further investment at the campus to significantly increase the Group’s footprint and provide an expanded presence within the European Union in preparation for Brexit.

This latest milestone follows Almac Clinical Services’ (Ireland) successful completion of a Health Products Regulatory Authority (HPRA) inspection of its bespoke 79,000ft2 EU distribution centre for clinical trial supply at the campus. Regulatory approvals are now in place in this new facility to enable GMP receipt & storage, QP certification, Just-in-Time labelling and global logistics.

In addition to the distribution centre, the European Headquarter campus also houses a state-of-the-art QC laboratory and dedicated packaging facility for commercial drug products operated by Almac Pharma Services (Ireland) which received HPRA approval in October 2018.

The combined services offered from the campus complement the existing clinical supply and drug product development operations provided from Almac’s Global HQ site in Craigavon, Northern Ireland, which is just 40 minutes, by road, from Dundalk.

Alan Armstrong, CEO Almac Group said, “I am pleased to note that we have made significant progress on our global growth strategy and I am proud to announce the completion of the final phase of our new European HQ campus in Ireland. Our global clients expect, and deserve, certainty and clarity as we prepare for Brexit and these facilities offers just that. This has been an extremely ambitious project and represents a key milestone in our success as we continue to strengthen and develop our capacity, capabilities and scale to meet growing client demand. We look forward to further developing this campus, and growing our team in Dundalk, as we continue to provide best-in-class services across the globe.”

This year, Almac reported a £17 million rise in turnover at £548 million for 2017-18 whilst average global employee figures increased by 8% to 4,798 for the same period. The Group continues to expand globally as it experiences increased demand for its wide range of services.

More about Almac European HQ campus can be viewed here.

#ENDS#

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Almac Group Hosts Montgomery County Students for National Manufacturing Day 2019

admin — Mon, 07 Oct 2019 12:30:10 +0000

Souderton, PA- 07 Oct 2019 – Almac Group, the global contract pharmaceutical development and manufacturing organization, is proud to announce the organization’s participation in MFG Day 2019.

Almac hosted more than 30 students and educators from North Montco County Technical Career Center’s Mechatronics class on October 4 as part of an effort to highlight modern manufacturing—a vibrant and growing industry that offers diverse career opportunities in all sectors. The event showcased the organization’s contract manufacturing business based at the company’s US headquarters in Souderton which currently employs over 1,300 people. Three interactive tours were provided for the North Montco students enabling them to see, first hand, Almac’s operations, production environments, and unique facility components and technologies.

MFG Day is an annual series of events held in communities across the country, and is supported by thousands of manufacturers who open their doors to students, teachers, parents and community members for tours and interactive sessions. The goal is to change perceptions of manufacturing and highlight the high-tech and innovative companies that are solving tomorrow’s challenges today.

“North Montco Technical Career Center is pleased to participate in National MFG Day 2019 with Almac,” said Gina Pardovich, Administrative Director, North Montco Technical Career Center. “North Montco has a long history of training students for the manufacturing industry. The students who participated in this event are able to benefit from innovative technology in the training environment enabling them to become skilled technicians ready to enter the workforce, or, preparing them for post-secondary education as engineers.”

“The MFG Day initiative allows manufacturing companies, like ours, to showcase to students what manufacturing looks like, and the impact a manufacturing-related career can have on a diverse number of industries,” said Rich Moore, US Director of Human Resources, Almac Group. “We are proud to highlight the innovative work we are doing here in Souderton to advance human health and hope our event inspires the next generation of workforce talent.”

First held in 2012, MFG Day is now organized by The Manufacturing Institute—the education and workforce partner of the National Association of Manufacturers. The kick-off events around the country and month-long initiative gives manufacturers the opportunity to address the skills gaps they face, connect with future generations, take charge of the public image of manufacturing and ensure the ongoing prosperity of the industry as a whole. Learn more about MFG Day and the significant impact this event has across the nation here.

#ENDS#

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

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Almac’s unique gene expression report enables cancer researchers to discover exciting new insights

admin — Thu, 26 Sep 2019 12:55:15 +0000

~ clara^T report now includes all ten Hallmarks of Cancer to aid novel Biomarker Discovery ~

Craigavon, N.I., 26 September 2019 – Almac Diagnostic Services, a member of the Almac Group, will launch the complete version of clara^T* at the ESMO Congress in Barcelona on 27th September.

The Almac clara^T Total mRNA Report content has expanded considerably from the initial version launched the previous year at the ESMO Congress. The complete version now includes 92 gene expression signatures, 100 single gene drug targets and over 7,000 additional biology linked genes, categorised by all 10 Hallmarks of Cancer.

The innovative clara^T Total mRNA Report benefits both academic and biopharma biomarker discovery and translational researchers by saving them valuable time in analysing gene expression data and helping to maximise the understanding of their dataset. clara^T analyses multiple published gene expression signatures that represent the Hallmarks of Cancer simultaneously, and presents the results in a comprehensive, easy-to-interpret format. Researchers are provided with an interactive report that facilitates easy visualisation of novel molecular subgroups within the sample cohort and the key discriminating biologies within an individual tumour sample.

By allowing multiple biologies to be evaluated in parallel, as opposed to the traditional method of focusing on one biology alone, the clara^T Total mRNA Report supports the identification of novel insights, highlighting consensus signatures within, and between, the Hallmarks of Cancer. This analysis allows researchers to confirm known findings in the field, but more importantly helps to identify new and unique observations such as novel pathways and biologies predicting response to therapeutic targets that may not yet be proven to do so.

One such researcher who has benefited from using Almac’s solution is Priyanka Sharma MD, Professor of Medicine at The University of Kansas Medical Centre & Vice Chair of the Breast Committee at South Western Oncology Group (SWOG). Dr Sharma stated: “RNA sequencing is a valuable tool for interpreting the gene expression shifts that occur in tumors as a result of cancer therapy. We recently used Almac’s innovative gene expression analysis tool, clara^T, to simultaneously assess multiple biologies in a breast cancer clinical trial cohort. clara^T analysis revealed the specific Hallmarks of Cancer and novel expression signatures that are directly associated with treatment response in this trial involving a drug targeting the PI3K pathway. We anticipate that these exciting new findings may guide future clinical trial design and patient selection criteria.”

RNA-Sequencing (RNA-Seq) data is complex and difficult to interpret, often requiring extensive bioinformatic capabilities. Almac has developed an optimised RNA-Seq platform alongside proprietary bioinformatics pipelines and software solutions to report and visualise this myriad of data in an intelligently simplified manner.

Professor Richard Kennedy, Global VP of Biomarker Discovery, Almac Diagnostic Services stated: “We are delighted to be able to assist leading cancer researchers like Dr Sharma with identifying exciting new data and look forward to the results being published in the near future. Our proprietary clara^T report has only been on the market for twelve months but has already generated considerable interest and has been adopted by some leading pharma companies and academic researchers for gene expression analysis. It has demonstrated its ability to accelerate RNA-based biomarker research, enabling deeper insights into translational cohorts for better trial stratification and potentially improving patient outcomes in the future.”

For further information on clara^T click here.

To discuss your RNA biomarker research project requirements and how clara^T can help, visit the Almac booth #473 at ESMO 2019.

*NOTE: The results displayed in the clara^T report are for research use only (RUO) and are not to be used for diagnostic or prognostic purposes, including predicting responsiveness to a particular therapy.

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specializing in biomarker driven clinical trials. The company is focused on the discovery, development and commercialization of diagnostic and companion diagnostic tests. We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialization. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials.

Click here for more information.

About Almac Group
A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac’s unique gene expression report enables cancer researchers to discover exciting new insights appeared first on Almac.

Almac Pharma Services Achieves Unprecedented Global Regulatory Milestone

admin — Wed, 25 Sep 2019 07:00:03 +0000

Three successful regulatory inspections completed in two weeks

Craigavon, U.K., 24 Sep 2019 – Almac Pharma Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, has announced the successful completion of three global regulatory GMP inspections across three facilities in the space of just two weeks.

The UK MHRA conducted a routine GMP audit at the company’s Charnwood, UK facility. The 230,000ft² site, based in Loughborough, was acquired by Almac in 2015 and provides GMP development and manufacturing of solid oral dose clinical trial materials and small scale commercial volumes. The three day inspection of the site’s quality systems resulted in no critical or major findings.

Meanwhile, the company’s global HQ site in Craigavon, Northern Ireland was received a general GMP inspection by the US FDA. Operations carried out at this site include GMP and non-GMP pharmaceutical development, commercial scale manufacturing and packaging of solid oral dose material, secondary labelling, serialisation and distribution of drug product globally. The inspection was also successful with no 483 issued.

Finally, the US FDA performed an unannounced inspection at the company’s Audubon, PA, USA facility which provides a range of specialised commercial packaging services including complex kit assembly for medical devices, combination products and biologic packs. The inspection covered general aspects of GMP and the company’s operations with biologic products and, again, closed with no 483 being issued.

Ian Markwell is the VP of Quality and has overall responsibility for the company’s global regulatory compliance. He said: “It is unprecedented for the Almac Pharma Services business to have three regulatory authority inspections within such a short period of time. It is a great credit to the skilled and experienced teams involved across all locations that they resulted in a positive outcome.”

With over 50 years’ experience and a wealth of expertise providing flexible, quality-led pharmaceutical solutions Almac was pleased to achieve complete success across all three sites confirming that no critical or major observations were raised throughout.

Responding to the news, Graeme McBurney, Managing Director & President, Almac Pharma Services commented “We recognise that quality determines the extent of our success and therefore place a high priority on ensuring our company-wide quality systems not only meet, but exceed, global regulatory standards. Successful completion of these inspections at our multiple global facilities reflects our ongoing commitment to quality and teamwork across the entire organisation.

“We are dedicated to investing further in our innovative systems thereby ensuring our clients continue to receive superior services enabling them to bring important new treatment to patients throughout the world.”

###

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Pharma Services Achieves Unprecedented Global Regulatory Milestone appeared first on Almac.

Almac Group Participates in Global Clinical Supply BlockChain Working Group

admin — Tue, 17 Sep 2019 07:00:08 +0000

Craigavon, N.I., 17 September 2019 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is pleased to announce its participation in the Global Clinical Supply BlockChain working group (GCSBWG).

Given how well-suited the BlockChain technology is for supply chains where numerous organisations must handle sensitive information, the multi-stakeholder group, spearheaded by Biogen and Pfizer, convened to explore whether technology could address the growing demands of clinical trials.

With Phase 1 of the GSCWG complete, the group has published a whitepaper entitled “Transforming Pharmaceutical Clinical Supply Messaging with BlockChain” which outlines the programme’s highlights to date. A proof-of-concept iOS mobile application called “KitChain MVP” has also been built upon a hyperleger fabric permissioned BlockChain infrastructure which stimulates discussion amongst clinical supply chain participants. The ultimate aim of the working group is to envision a messaging and notification platform which can support the performance requirements of the whole clinical supply chain.

Almac’s Mark Hanly, Strategic Business Analysis Manager and Mark McColgan, Software Development Manager, will continue to work alongside a diverse group of global academia, pharmaceutical companies and other Contract Manufacturing Organisations through the next phases of the working group and contribute pertinent insight and debate. With this group there was significant potential to enhance the depth and breadth of knowledge on how BlockChain could potentially be applied in the industry.

Andrew Hillis, Vice President and Group Head of Information Services, Almac Group, commented:
“The rapid adoption of BlockChain technology, coupled with its clear applicability to the clinical supply chain, make this project extremely timely and relevant to meeting the future challenges our industry. We’re privileged to contribute our experiences and perspectives as one of the world’s largest global clinical supply providers to this endeavour that if successful, will undoubtedly have a major impact on clinical sites and ultimately, patients.”

ENDS

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Participates in Global Clinical Supply BlockChain Working Group appeared first on Almac.

Almac Group Invests in Future Employees through Apprenticeship Schemes

admin — Mon, 16 Sep 2019 09:58:53 +0000

Craigavon, N.I., 17^th September 2019 – Almac Group, the Craigavon based global pharmaceutical contract and manufacturing company, has concentrated efforts to encourage young people to continue further studies of STEM related subjects through its dedicated outreach strategy.

As part of its commitment the company is continuing to invest in its employees’ futures through funding and supporting Higher Level Apprenticeships (HLA) in both analytical chemistry and computing. Over the past four years, a team of experts, from various departments across the Almac Group, has worked closely with the Southern Regional College (SRC) to contribute valuable industry input to its HLA curriculum and help shape their popular and beneficial ‘earn as you learn’ programmes.

This year Almac is celebrating the recent success of its first HLA Graduates of the Applied Industrial Sciences (Chemical Sciences Pathway) programme – a two-year, part-time course which commenced in 2016. Students Maura Donnelly from Coalisland & Michelle McKinstry from Lisnadill, Armagh, are both employed as Analytical Apprentices at Almac’s global Headquarters in Craigavon. Throughout the course they worked four days a week and used their enhanced understanding of theoretical techniques drawn from their studies to better develop and troubleshoot methods for Almac’s global clients.

Maura was also recognised for excelling in her studies by being awarded this year’s BT Award for Excellence. This prestigious prize is awarded to the student who is studying a course with a blended learning aspect and has worked consistently and enthusiastically throughout the duration of the course.

Dr Frances Weldon, STEM Outreach Manager, Almac said: “The content covered in the HLA courses is highly relevant to the work performed within many parts of Almac and our Higher Level Apprentices benefit greatly from the additional workplace learning and mentorship they receive in techniques and sector-specific practices as part of their training.

“We are only too proud to have been involved in the development of high quality career pathways in both computing and chemical sciences and to have the students work with us as Apprentices during their studies. As a company, we benefit greatly from the increased knowledge and applied learning introduced to the business, whilst enabling the students and graduates to progress and develop their own career from within. Well done to Michelle and Maura on their achievements and we wish them the best for the next stage of their education.”

Both Maura and Michelle now progress to Level 8 – BSc Applied Pharmaceutical Sciences at Ulster University.

ENDS

Photo caption: L-R:– Tanya Graham, Analytical Manager, Almac, Michelle McKinstry, Maura Donnelly & Ann Heslip, Analytical Technical Leader at Almac.

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com

The post Almac Group Invests in Future Employees through Apprenticeship Schemes appeared first on Almac.

Almac Group to Host Clinical Trial Supply Workshop in Germany

admin — Tue, 13 Aug 2019 06:00:33 +0000

Craigavon, U.K., 13 Aug 2019 – Almac Clinical Services, part of the global contract pharmaceutical development and manufacturing organisation the Almac Group, is delighted to invite participants from the pharmaceutical and biotechnology industry to join its upcoming complimentary Workshop in Frankfurt on Thursday 12th September 2019.

Hosted at the Radisson Blu, Hotel from 11:00am – 5:00pm, the specifically designed session will examine “Clinical Trial Supply and Technology: A proven approach to achieve supply chain harmony.” Leading the workshop will be Almac’s subject matter experts, including Meryvn Preston, Supply Chain Management Project Group Manager, Andrew Thress, Project Group Manager, SCM and Brian Mullin, Clinical Project Services Manager. Andrew Scott, Head of Logistics (EU) Almac Clinical Services will also lead a BREXIT panel discussion.

Almac understands the challenges faced by biotechnology and pharmaceutical companies in an ever-evolving industry. Using real-life scenarios and interactive group discussions, participants will learn how to achieve an integrated, simplified and optimised clinical supply chain as well as discuss how to overcome the barriers posed by the management of clinical supplies.

Speaker, Mervyn Preston, commented on the upcoming workshop:

“The primary goal of this workshop is for attendees to leave with a wealth of knowledge on how to execute their trials more effectively based on a solid understanding of having a harmonised physical and digital clinical supply chain. We are excited to be hosting this exclusive session in Germany which will also give participants an opportunity to get to know our facilities, capabilities and services.”

As industry leading experts, Almac hopes that the information presented during this complimentary workshop will help to guide clinical supply professionals throughout their clinical supply journey.

To find out more and to sign up, please click here.

ENDS

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group to Host Clinical Trial Supply Workshop in Germany appeared first on Almac.

Almac Group’s Position Remains Unchallenged in Ulster Business Top 100 Listings

admin — Thu, 08 Aug 2019 07:19:56 +0000

Craigavon, N.I., 07 Aug 2019 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is privileged to be included in the top ten list of “Ulster Business Top 100 companies” for the second consecutive year.

The news comes as the Group’s figures for year ending 30 September 2018 reported a £17 million rise in revenue at £548 million with pre-tax profits recorded at £27 million.

In a supplementary table listing the most valuable firms in Northern Ireland, the global organisation, now with a tangible net worth of £285.7 million, was recorded in eighth position while it was listed as the second highest employer which had increased in 2017/18 by over 8% to 4,798.

Kevin Stephens, Almac Group Finance Director, commented: “As we celebrate 50 years of success I am delighted to see Almac highly ranked in the Ulster Business Top 100 companies once again. We are committed to providing our growing client base with the most innovative and efficient service in our marketplace and achieving recognition in this listing, published by Ulster Business, is testament to the continued dedication and contribution of our ever increasing global and diverse employee base.”

The Ulster Business Top 100 list is sponsored by A&L Goodbody and uses a combination of data sourced from both Dun & Bradstreet’s information database and Companies House. It incorporates the results of Northern Ireland based companies, either Northern Ireland registered, or when a significant portion of their business is driven and transacted through the province.

Michael Neill, head of office, A&L Goodbody Belfast, said: “The results of this resilience and determination speak for themselves in this year’s Top 100 rankings, with collective turnover increasing by 9.4% in the 12 months to £24.8bn. While many companies are long-standing players and remain unchallenged at the top end of the rankings, it is positive to see businesses continue to rise up the ranks, year-on-year.”

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group’s Position Remains Unchallenged in Ulster Business Top 100 Listings appeared first on Almac.

Almac Group to Host EU Product Launch Workshop Series in California and Washington States

admin — Mon, 05 Aug 2019 07:07:35 +0000

Craigavon, U.K., 05 Aug 2019 – Almac Pharma Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, is inviting members of the pharmaceutical and biotechnology industry to join its upcoming complimentary workshop series this September.

During these specifically designed knowledge sharing sessions, Almac’s subject matter experts will guide participants through the product launch timeline from Phase 3 to commercial launch and share valuable insights into the key requirements and considerations to ensure commercial launch in Europe is successful.

The three individual sessions will be hosted on Monday 16th September in the Hilton San Fran Airport Bayfront, San Francisco, CA; the Marriot La Jolla Hotel, San Diego, CA on Tuesday 17th September with the final workshop taking place on Thursday 19th September in the Pan Pacific Hotel, Seattle, WA.

Almac understands that launching drug product can be challenging, especially if sponsors are not familiar with the key milestone requirements that should be met at various time points in the MA submission process. Using real-life scenarios and interactive group discussions, participants will learn about the European regulatory framework and how this determines all launch milestones, understand the importance of the Qualified Person (QP) and QP declarations and identify top operational considerations as you progress to commercialisation and much more.

Workshop host, Adam Schroeder, Director of Business Development at Almac Pharma Services, commented on the upcoming workshop: “We are excited to offer this series of workshops in three significant locations across the west coast. The combination of interactive presentations, round table discussions and networking at these events will prove invaluable for participants wishing to find out more about launching their product into Europe. We look forward to sharing our industry insights and expertise with those attending in September.”

To find out more and to sign up, please click here.

ENDS

About Almac Group
A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group to Host EU Product Launch Workshop Series in California and Washington States appeared first on Almac.

Almac Group Invites Biopharma Industry Members to Learn About Almac Adapt™ – Just in Time Manufacturing at Complimentary Workshop

admin — Wed, 31 Jul 2019 12:50:57 +0000

Souderton, PA, U.S., 31 July 2019 – Almac Clinical Services, part of the global contract pharmaceutical development and manufacturing organization the Almac Group, is delighted to invite participants from the Biopharma industry to join its Souderton Lunch and Learn Workshop on Wednesday, September 18. This session will provide all participants with an understanding of what is needed to develop a truly robust JTM strategy for their individual clinical trials and will support the recent launch of Almac Adapt™ – an innovative Just in Time Manufacturing (JTM) solution.

The drive to optimize the performance of clinical trials is increasing with a positive impact on clinical development, however this has also brought some new challenges for Biopharma to overcome. This includes aggressive study timelines, rising costs, and the necessity to supply smaller, global clinical studies for specifically targeted populations. It is with these challenges in mind that Almac has developed its Almac Adapt™ – Just in Time Manufacturing (JTM) solution.

The complimentary workshop will be held from 11:00 am to 2:00 pm on Wednesday, September 18 at Almac Group’s US headquarters in Souderton, PA. Almac’s subject matter expert with over 15 years’ experience within the industry, Natalie Balanovsky (Almac’s JTM Solutions Manager), will host the exclusive masterclass titled, “Almac Adapt™ – Just in Time Manufacturing – Optimizing Flexibility and Adaptability.”

Natalie comments on the upcoming workshop: “This is an exciting year for the Almac Adapt team, and I am delighted to share my knowledge and expertise on this important subject matter at the upcoming Lunch and Learn. The session aims to provide participants with a thorough understanding of the importance of adopting an agile clinical supply chain. We will also discuss how Almac Adapt aligns speed with need throughout the clinical supply chain, to meet the variable demands of sites and patients, whilst effectively controlling costs. Almac understands that time is precious for all sponsors, we understand the challenges our clients face at a deeper level and it is with that in mind we have crafted this educational session.”

To find out more and to sign up please click here.

ENDS

About Almac Group
A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Invites Biopharma Industry Members to Learn About Almac Adapt™ – Just in Time Manufacturing at Complimentary Workshop appeared first on Almac.

Almac Diagnostic Services Launches Sample Management Service

admin — Wed, 31 Jul 2019 10:14:57 +0000

Almac Diagnostic Services Launches Sample Management Service to Streamline Biomarker Programmes for Clients

Craigavon, N.I., 31 July 2019 – Almac Diagnostic Services, a global stratified medicine company and member of the Almac Group, today announced the launch of its Sample Management Service.

This latest support offering includes pathology review & digital pathology, sample receipt and accessioning, sample storage and downstream processing. The service provides clients with the reassurance that samples are being stored safely, with reliable up-to-date information about sample inventory, ultimately enabling ready access to samples upon request.

Almac Diagnostic Services has over 15 years’ experience in sample preparation, analysis and reporting and as part of the Sample Management Service, offers a dedicated point of contact throughout an entire project. This, coupled with Almac’s unique LIMS barcode system, ensures sample traceability and full chain of custody, alongside bespoke data management reporting to suit client’s exact requirements.

A range of secure storage solutions are available at Almac Diagnostic Services’ facilities to suit individual study needs including ambient and cold storage which are temperature controlled, fully validated and HTA compliant, and monitored 24/7.

Whether clients are benefitting from Almac Diagnostic Services’ downstream sample processing services such as DNA/RNA extraction, DNA panel /RNA panel Next Generation Sequencing, Whole Exome Sequencing (WES) or if they require the analysis to be performed externally with another vendor, the new Sample Management Service helps coordinate these activities on the client’s behalf.

Dr Leeona Galligan, VP UK Operations, Almac Diagnostic Services, commented “The addition of this Sample Management Service to our growing portfolio of service offerings is further evidence of our commitment to provide a fully integrated laboratory service to our global biopharma client base. We have established a dedicated team to deliver this offering which will ultimately help simplify and streamline the clinical trial process for our customers and I am delighted to launch this new service.”

To find out more about Almac Diagnostic Services’ Sample Management Service, please visit:

https://www.almacgroup.com/diagnostics/clinical-trial-solutions/sample-management/

#END#

About Almac Diagnostic Services

The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics.

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac Diagnostic Services Launches Sample Management Service appeared first on Almac.

Almac Group Promotes High Flying STEM Careers at Airwaves Portrush

admin — Fri, 26 Jul 2019 13:27:40 +0000

Craigavon, N.I., 26 July 2019 – From 31st August to 1st September, a team of STEM (science, technology, engineering & maths) Ambassadors from global pharmaceutical and development organisation, Almac Group, will encourage attendees of all ages to participate in a range of fun, interactive science experiments at this year’s Airwaves Portrush event.

Visitors to the Almac exhibition will have the opportunity to learn more about the wide and varied range of careers available across its global sites and speak to employees about their own career paths. The more adventurous amongst the attendees can get involved in hands-on experiments that have been specifically designed to demonstrate key scientific principles used daily by chemists and biologists in Almac’s laboratories– including creating elephant toothpaste and, everyone’s favourite, making slime!.

The exhibition will take place as part of the Airwaves event’s “STEM Village”, which was introduced as part of the event programming in 2016 to showcase a variety of employers and educators that promote STEM education to visiting crowds. This year, attendance is expected to exceed 150,000.

Frances Weldon, STEM Outreach Manager Almac, said, “It’s our priority to meet and expose as many young people as we can to exciting career pathways in STEM, and exhibiting at the STEM Village provides a great opportunity to engage with many who may be interested in pursuing a STEM career. Our hands-on experiments aim to demonstrate scientific principles used every day at Almac and to show students how fun and engaging STEM subjects are when observed as real world biology and chemistry applications. We look forward to meeting people of all ages at Airwaves Portrush’s STEM Village!”

Experiments planned for the exhibition include:
• Creating ‘elephant toothpaste’
• pH experiments using every day household products
• Separation of dye pigments using paper chromatography
• Making slime
• Strawberry DNA extraction
• Indigo carmine traffic light experiment

#ENDS#

About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac Group Promotes High Flying STEM Careers at Airwaves Portrush appeared first on Almac.

Arran Chemical Company forms Unique Industry – Academia Collaboration with Athlone Institute of Technology

admin — Mon, 08 Jul 2019 10:19:03 +0000

Four year PhD scholarship will deliver novel, greener chemical synthesis modalities

Athlone, Ireland, 08 Jul 2019 – Arran Chemical Company, a member of the Almac Group, has embarked on a unique collaboration project with Athlone Institute of Technology (AIT) to support a four year PhD programme which will see the use of biocatalysis in the asymmetric synthesis of chiral amines and diamines.

Leading the project is Lauryn Bracken who was the 2019 recipient of AIT’s President’s Doctoral Scholarship award. Lauryn, from Tullamore, County Offaly, Ireland, recently completed a BSc (Hons) in Pharmaceutical Science at AIT and will commence the project in October. She will be jointly supervised by Dr. Noreen Morris, Lecturer in Chemistry and Dr. Sean Reidy, Lecturer in Chemistry, AIT, in collaboration with Professor Tom Moody, VP of Technology Development and Commercialisation, Almac Sciences & Arran Chemical Company and Dr. Peter Cairns, Technical Manager, Arran Chemical Company.

The project will focus on greener and more economic alternatives to chemical production methods for the synthesis of chiral amines and diamines. Approximatively 80% of Active Pharmaceutical Intermediates (APIs) contain groups derived from amines. It is therefore essential that new methodologies are explored to expedite their synthesis.

The basic concept of the project is to displace multistep chemical routes currently used for the synthesis of chiral amines and diamines to simpler, lower cost and less polluting enzymatic processes. Biocatalysis offers an attractive approach for synthesis resulting in greener processes and real benefits for both the environment and overall cost of goods. General benefits of enzyme chemistry include use of water as a safe solvent, lower temperatures and selectivity that is unachievable by chemical methods.

AIT has established strong links with Arran Chemical Company over many years and, together, have carried out a variety of projects on the synthesis and separation of amines. This project has the backing of Professor Moody, who commented: “We are delighted to be supporting AIT once again and look forward to working together over the next four years. Almac will supply the college with all the necessary biocatalysts needed for this investigation and, of course, guidance and expertise from our specialists in this field. We wish Lauryn every success in her PhD project.”

Dr Morris stated “This project has the exciting prospect of exposing both the student and supervisors to new and exciting areas of research. A collaboration with Arran Chemical Company, an established chemical company with a wealth of experience which works with clients globally, will raise the profile of Athlone Institute of Technology as a base of R&D excellence and lead to further opportunities for collaborative research in the future.”

#End#

About Arran Chemical Company
Arran Chemical Company – a member of the Almac Group – is a fine chemical company specialising in the manufacture of products for pharmaceutical and health care, flavour/fragrance, personal care, and other specialised chemical and industrial applications.

We are specialists in chiral chemistry using both chemocatalysis and biocatalysis technologies, but also have practical operating experience over a wide range of modern synthetic reactions. We offer our clients superior chemical solutions with a high rate of success.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Arran Chemical Company forms Unique Industry – Academia Collaboration with Athlone Institute of Technology appeared first on Almac.

Almac McKervey Award Presented for Excellence in Chemistry

admin — Tue, 02 Jul 2019 12:49:57 +0000

Craigavon, N.I., 01 July 2019 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has today announced this year’s recipient of the ‘Almac McKervey Award for Excellence in Organic Chemistry’.

Prof Tom Moody, VP Technology Development and Commercialisation, Almac Sciences, presented the award to Jonathan during the Queen’s School of Chemistry and Chemical Engineering Graduation awards ceremony on 28^th June. Jonathan, who is from Richhill, also received a £1,500 bursary towards his tuition fees and a 12 month placement with Almac to gain practical industry experience and mentorship.

Prof Moody said: “I am pleased to present today’s Almac McKervey Award to Jonathan in memory of our esteemed colleague and friend Tony. Jonathan has demonstrated exemplary performance throughout his degree to date and I hope, that in receiving this recognition today, he will progress to a long and rewarding career in chemistry. Many congratulations.”

Upon receiving the award, Jonathan said: “I am thrilled to accept this prestigious award from Almac and Queen’s. The practical experience I will gain during my work placement at Almac will enable me to deepen my knowledge and understanding of organic chemistry as I learn from the experts. Professor McKervey was such an inspiration to students and I am humbled to receive an award in his name.”

Dr Gary Sheldrake, Deputy Head of School, said: “Our connection with Almac and Professor McKervey in both research and teaching go back many years to the very roots of the company. We are delighted that Almac has decided to remember Tony by establishing this prestigious Award and we wish to extend our congratulations to Jonathan as well for this recognition of his achievement.”

Following the ceremony, Jonathan’s name was added to the perpetual commemorative wall plaque at the David Keir building at Queen’s- a replica of which is displayed at Almac’s global headquarter facility in Craigavon.

#END#

Notes to Editor

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac McKervey Award Presented for Excellence in Chemistry appeared first on Almac.

Almac Group Launches Almac Adapt™ – a New Patient-centric Supply Solution

admin — Thu, 13 Jun 2019 07:55:30 +0000

Innovative Just in Time Manufacturing (JTM) enables sponsors full late stage customisation of their clinical trial materials

Craigavon, N.I., 13 June 2019 – Almac Clinical Services, part of the Almac Group, has today announced the launch of Almac Adapt™ – an innovative Just in Time Manufacturing (JTM) solution. This latest offering puts patients first and provides sponsors with a unique, adaptive supply strategy to ultimately meet the expanding challenges of clinical trials.

The drive to optimize the performance of clinical trials is increasing. Positive advancements, like the growth in development of targeted biopharmaceutical therapies and new trial designs, have had an impact on clinical development but have also brought new challenges to overcome. These challenges have resulted in aggressive study timelines, rising costs, the need for supply chain flexibility and the necessity to supply smaller, yet more global, clinical studies for specifically targeted populations.

With Almac’s wealth of experience and understanding that time is a precious commodity for sponsors, its team of experts recognise the importance of having an agile clinical supply chain that meets the ever changing needs of an evolving clinical trial landscape and it is with this in mind that Almac has redefined the supply chain experience and developed Almac Adapt.

The Almac Adapt solution offers the generation and delivery of kits to sites and patients worldwide in a matter of days, avoiding needless delays and over-production of sponsor’s high value drug product. By shifting the focus from what we do to why we do it, Almac Adapt™ embodies this understanding in a patient-centric culture by translating itself into an actionable and proactive manufacturing, packaging, labelling and distribution solution.

When necessary, Almac Adapt can be coupled with Almac’s dedicated supply chain experts who with precision thinking, aligns ‘speed’ with ‘need’’. This is offered by utilising its flexible forward planning and adaptive on-demand supply chain enabling the efficient resolution of mid-study protocol and patient demand changes whilst ensuring the quality and compliance of the product. This can also dramatically reduce overage of expensive IMP where wastage is not an option, in turn reducing costs for the sponsor.

This solution manipulates the global supply chain and bridges the gap between supply and demand – optimising on-time delivery for patients, inventory flexibility for sites whilst achieving key time-based milestones for the sponsor.

Natalie Balanovsky, Almac Clinical Services’ Just in Time Manufacturing (JTM) Solutions Manager comments:

“The introduction of Almac Adapt further enhances Almac’s industry-leading capabilities within Clinical Trial Supply showcasing our commitment to advancing human health. We understand the challenges our clients are facing at a deeper level and we have the resource, experience and expertise to help by developing a robust Just in Time strategy. Working directly with sponsors we will deliver a flexible, adaptable and patient–centric supply solution. Because time is precious to both sponsors and patients nothing is more important to us than ensuring we deliver on this promise. I am delighted to announce the launch of Almac Adapt.”

ENDS

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn.

The post Almac Group Launches Almac Adapt™ – a New Patient-centric Supply Solution appeared first on Almac.

Almac Group Announces CE Mark of Diagnostic Assay to Support Turning Point Therapeutics’ Pivotal TRIDENT-1 Clinical Trial

admin — Wed, 05 Jun 2019 13:00:38 +0000

Achievement marks further progress towards development of therapy and assay to assist treatment of patients with unmet medical needs

Craigavon, N.I., 05 June 2019 – Almac Diagnostic Services, a global stratified medicine company and member of the Almac Group, today announced the successful CE marking of the diagnostic assay that will be used to determine molecular eligibility for enrolment into the pivotal Phase 2 portion of Turning Point Therapeutics’ TRIDENT-1 clinical trial.

The next-generation sequencing (NGS) assay is intended for use in identifying patients with ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumours.

Commenting on the CE mark, Stewart McWilliams, Global VP of Quality & Regulatory Affairs at Almac Diagnostic Services said: “CE marking of the assay allows it to be utilised for screening trial subjects for enrolment. In addition, it provides quality assurance of the assay’s analytical performance and demonstrates that the product meets the essential requirements of the European In Vitro Diagnostic Directive 98/79/EC for its intended use.”

This important milestone follows swiftly on from the recent announcement by Turning Point Therapeutics and Almac Diagnostic Services of the US Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) approval of the assay. The CE marking of the assay evidences the further utility of the test to support the European portion of the global TRIDENT-1 clinical study.

Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI), developed for the treatment of patients with advanced solid tumours harbouring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.

Turning Point Therapeutics’ TRIDENT-1 Phase 2 open-label, multi-cohort study is planned for initiation in the second half of 2019.

“Each milestone in our development of repotrectinib brings us one step closer to the ultimate goal of reaching global patients with new therapeutic options for their cancer,” said Athena Countouriotis, M.D., President and Chief Executive Officer of Turning Point Therapeutics. “We are pleased to gain the CE Mark for the companion diagnostic assay as we continue our planning to initiate the global Phase 2 portion of Trident-1.”

#END#

About Almac Diagnostic Services

The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics.

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

About Turning Point Therapeutics Inc.

Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients, and is planned to enter a registrational Phase 2 study in the second half of 2019. Turning Point’s kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment.

For more information, visit www.tptherapeutics.com.

The post Almac Group Announces CE Mark of Diagnostic Assay to Support Turning Point Therapeutics’ Pivotal TRIDENT-1 Clinical Trial appeared first on Almac.

Almac Group Reports Further Growth During Period of Significant Global Expansion

admin — Mon, 03 Jun 2019 12:00:56 +0000

2017-18 figures record turnover increased by £17 million with 8% growth in global workforce

Craigavon, N.I., 3 Jun 2019 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has reported a £17 million rise in turnover from £531 million to £548 million for 2017-18. Pre-tax profits were recorded at £27 million whilst average employee figures increased by 8% from 4,407 to 4,798 for the same period. The figures were recorded in Almac’s annual report with its results for the year ending 30 September 2018.

Throughout this period, the Group made a number of significant investments including further development of its European Campus in Dundalk, Ireland, a multimillion pound expansion of capacity at its site in Athlone in addition to further investment at its existing facilities in the UK, US and Asia.

Global expansion continued with the acquisition of Athlone-based, BioClin Laboratories, which significantly increased its global analytical services capabilities.

Delivering upon its outreach strategy, Almac also has committed to invest over £1 million through a partnership agreement with W5 in Belfast, Ireland’s interactive science centre, to enhance STEM (Science, Technology, Engineering & Maths) knowledge and understanding among the next generation.

Alan Armstrong, Group CEO, commented: “Almac experienced yet another strong year in 2018 with our key financial and global employee metrics increasing. We made significant progress on our ambitious growth strategy with the acquisition of BioClin Laboratories and the continued investment in our existing global facilities, in addition to increased headcount. With 100% of our profits reinvested into the business, we will continue to innovate and improve our wide range of services and products to ensure we provide the premium solutions our global client base relies on.”

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Reports Further Growth During Period of Significant Global Expansion appeared first on Almac.

Queen’s researchers work to improve maternal health in the developing world

admin — Wed, 29 May 2019 07:00:41 +0000

Craigavon, UK, 28 May 2019

A grant from the McClay Foundation will enable Queen’s researchers to work with clinicians to offer fast diagnostic testing to prevent meningitis and sepsis in maternity wards for the first time in Malawi.

Maternal health is a huge issue in developing countries where 99 per cent of all maternal and neonatal deaths occur ¹. The neonatal mortality rate is also much higher in Africa, at four times higher than that of developed regions².

Women and babies die as a result of complications during, and following, pregnancy and childbirth, including infection.

Queen’s University Belfast in collaboration with HiberGene Diagnostics and Belfast Health & Social Care Trust have developed an innovative rapid test for GBS using LAMP (Loop-mediated isothermal AMPlification) technology. The HiberGene test can identify GBS with very high accuracy within one hour, so it can be used during labour – a strategy called intrapartum testing. Intrapartum is considered the most accurate time to test as it prevents unnecessary antibiotic use or missed GBS infections. The test is also simple enough to use as a “near patient” test, in a small lab or room next to a ward, without the need for extensive laboratory training. Queen’s researchers will work with trained clinicians in a number of maternity wards in Malawi, to use the LAMP test.

Principal Investigator Professor Mike Shields from the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s University Belfast explains: “In developing countries, where access to laboratory testing is sparse, these tests could have a huge positive impact on the health of mothers and their babies. Detecting the GBS within the hour will mean that GBS positive women can be identified and given antibiotics to prevent transmission of GBS during delivery that could lead to serious infections including meningitis, sepsis and death.”

Around 25 per cent of pregnant women are colonised with the bacterium Group B Streptococcus (GBS).³ The majority of pregnant women who carry this bacterium will never be aware. However, it can be fatal in instances when it is passed to babies during childbirth.

Although this is extremely rare in the developed world, in developing countries where there are many risk factors including inadequate services, distance and poverty, the prevalence of serious GBS infection to new-borns is much higher.

GBS can be difficult to detect as the mother who carries the bacteria often shows no symptoms. In many developed countries, testing for GBS in pregnancy is carried out two to four weeks before delivery, to enable GBS positive women to be given antibiotics to prevent transmission of the infection to the baby during childbirth. The turnaround for current tests is 48 hours, which means testing during labour is not feasible.

In the developing world, testing that requires a laboratory can be prohibitively expensive and very difficult to access in practical terms, particularly in rural settings. In reality, conventional testing for GBS is not available in most developing countries, meaning proven strategies to prevent GBS transmission cannot be used.

¹ https://www.who.int/news-room/fact-sheets/detail/maternal-mortality

²UNICEF. Neonatal Mortality. https://data.unicef.org/topic/child-survival/neonatal-mortality/. Published 2017. Accessed May 9, 2019.

³ Support GBS. What is group b Strep? https://gbss.org.uk/info-support/pregnancy-and-birth/what-is-group-b-strep/. Published 2019. Accessed May 8, 2019.

The McClay Foundation has supported this project enabling clinicians in the developing world to detect this life-threatening pathogen within an hour at a maternity ward using the HiberGene GBS test.

ENDS

About Almac Group
A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn.

The post Queen’s researchers work to improve maternal health in the developing world appeared first on Almac.

Almac Group appoints Dr Sheryl Foster as Vice President of Quality

admin — Tue, 28 May 2019 08:55:43 +0000

Craigavon, UK, 28 May 2019 – Almac Sciences, a member of the Almac Group, today announced the appointment of Dr Sheryl Foster to the position of Vice President of Quality, reporting to Managing Director & President, Dr Stephen Barr.

Dr Foster will assume overall responsibility for global Quality Assurance across the Almac Sciences’ sites across Europe and the US driving the strategy and policy for quality excellence.

In addition to her direct quality responsibilities, Sheryl will also participate as a member of the Almac Sciences’ senior leadership team assisting with strategy development and implementation aimed at driving further growth and of the global business.

With extensive quality experience gained over the last 20+ years Sheryl is a highly respected quality professional. Her most recent roles were as a Product Quality leader for GSK in Singapore and most recently as Director of Quality for Avara’s API Manufacturing site in the UK. Prior to this, Sheryl worked in a number of quality roles in the UK, China and Australia.

Following this appointment, Almac Sciences’ current VP Quality Operations, Dr John Robson, will focus his attention on its Analytical services offering as the VP of Analytical Operations.

Dr Barr, commented on Sheryl’s appointment: “Sheryl is a highly experienced quality manager with a wealth of expertise, understanding and industry insight which will prove instrumental in the development of our business as we continue to expand globally. We are delighted to welcome her to our senior management team.”

ENDS

About Almac Group
A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn.

The post Almac Group appoints Dr Sheryl Foster as Vice President of Quality appeared first on Almac.

Turning Point Therapeutics and Almac Diagnostic Services announce approval of an investigational device exemption for the companion diagnostic assay to the registrational TRIDENT-1 clinical study

admin — Mon, 06 May 2019 14:42:59 +0000

SAN DIEGO, May 6, 2019 – Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing novel drugs that address treatment resistance, and Almac Diagnostic Services, a global stratified medicine company, today announced approval by the U.S. Food and Drug Administration (FDA) of an investigational device exemption (IDE) for the diagnostic assay that will be used in Turning Point’s registrational phase 2 clinical study.

The next-generation sequencing (NGS) assay is intended for use in identifying patients with ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors. Clinical investigators will use the diagnostic test to determine molecular eligibility for enrollment into Turning Point’s registrational Phase 2 portion of the global TRIDENT-1 clinical study.

“We are pleased to achieve this important milestone with our partner Almac, moving us closer to the start of our pivotal study for repotrectinib in the second half of 2019,” said Athena Countouriotis, M.D., president and chief executive officer. “With a clear unmet medical need for therapies that target genomic alterations in different cancers, the diagnostic assay will provide clinical investigators with timely information to confirm the presence of the oncogenic drivers we continue to study in patients with advanced solid tumors.”

Almac has been developing the NGS diagnostic based on Archer Dx’s Anchored Multiplex PCR (AMP™) chemistry, with the intent of submitting it for regulatory approval in the United States and using it initially at Almac’s CLIA-accredited laboratory in Durham, N.C. to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.

“We are very pleased to have been granted IDE approval by the FDA for the development and validation of this complex NGS diagnostic assay for its intended use as a clinical trial assay,” said Paul Harkin, President & Managing Director, Almac Diagnostic Services. “We are delighted to assist Turning Point Therapeutics with this important upcoming clinical study, and furthering our partnership to progress such a promising investigational therapy as repotrectinib.”

Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI) developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is much smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.

Turning Point Therapeutics’ TRIDENT-1 Phase 2 open-label, multi-cohort study is planned for initiation in the second half of 2019.

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specializing in biomarker driven clinical trials. The company is focused on the discovery, development and commercialization of diagnostic and companion diagnostic tests. Almac partners with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialization. Almac also facilitates biomarker clinical trial management and clinical test delivery from its CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials. For more information visit: almacgroup.com/diagnostics

About Turning Point Therapeutics Inc.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, and the other risks described in Turning Point Therapeutics’ filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

ENDS

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Turning Point Therapeutics and Almac Diagnostic Services announce approval of an investigational device exemption for the companion diagnostic assay to the registrational TRIDENT-1 clinical study appeared first on Almac.

Almac Group Launches TempEZ™ Site Storage Temperature Compliance Module

admin — Thu, 25 Apr 2019 07:00:05 +0000

A truly end-to-end regulatory compliant clinical supply chain solution

Durham, N.C., 25 Apr 2019 – Almac Clinical Services, part of the Almac Group, the global contract pharmaceutical development and manufacturing organization, has today announced the launch of the Site Storage Temperature Compliance module to its TempEZ™ platform. This additional component provides customers with a solution to digitize, visualize and manage temperature data held by the clinical sites.

TempEZ is Almac’s market leading web-based, temperature data management software. It provides sponsors with a single, secure database to collect the temperature data, required by GDP regulations, to prove their products have been stored within the label claim throughout the supply chain. TempEZ gives clients data visibility from manufacture to patient administration, flexibility to utilize any monitor brand, automates excursion management and moves data from paper to computerized records.

TempEZ’s Site Storage Temperature Compliance module, developed by Almac’s global in-house experts, is a welcome addition to Almac’s already established temperature management portfolio. The bespoke solution was developed to reduce the data collection burden at clinical sites and to improve the visibility of temperature data held by the clinical sites for both clients and CROs. The solution essentially closes the data gap which currently exists at clinical sites making temperature data visible and readily available.

“Almac’s TempEZ is the only software platform that offers sponsors a complete, end-to-end temperature history of their drug product,” explains Donna Christopher, Global Vice President Operations, Almac Clinical Services. “The focus for temperature data collection has typically been on transit data. However, drug products spend more time at the clinical site than in transit, resulting in the majority of temperature excursions occurring at the site. We need to focus our data collection efforts at this point to enable these excursions to be identified and adjudicated quickly, thus safeguarding the patient. In the current climate, sponsors have difficulty accessing temperature data held at the clinical sites. This release of TempEZ digitizes any form of temperature data and makes it visible and readily available to sponsors and CROs. In addition, CRAs can remotely query the data directly from TempEZ. I am delighted to announce the launch of our new functionality.”

Find out more about Almac’s TempEZ solution here.

Join Almac’s Supply Chain Solution Managers, Heather Bogle and Sarah Smyth at the upcoming, Global Clinical Supplies Group (GCSG) conference in San Antonio, US from 28^th April – 1^st May as they present ‘Temperature Data at the clinical site; the missing piece of the puzzle’.

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Launches TempEZ™ Site Storage Temperature Compliance Module appeared first on Almac.

Almac Group Partner with Queen’s Researchers to pioneer potentially life-changing oesophageal cancer test

admin — Thu, 18 Apr 2019 14:39:17 +0000

18 Apr 2019 – Researchers at Queen’s University Belfast and the University of Cambridge, in partnership with the stratified medicine company Almac Diagnostic Services, has validated a test that for the first time could enable clinicians to decide the most appropriate chemotherapy for early stage oesophageal cancer. This personalised medicine approach of tailoring treatment to the individual could lead to more patients having their tumours successfully removed, improving their prognosis and quality of life.

Current treatment for oesophageal cancer involves a course of standard chemotherapy aiming to reduce the tumour size before follow-up surgery can be carried out to remove it. Only around 20 per cent of tumours will reduce in size following the standard course of chemotherapy. For oncologists identifying the most effective chemotherapy to reduce the size of oesophageal tumours before they are operated on is a challenge.

Dr Richard Turkington, Senior Clinical Lecturer at Queen’s University Belfast, and lead author on the study explains: “The UK has the highest incidence in the world of a particular type of oesophageal cancer called oesophageal adenocarcinoma, with 16,000 cases each year. One-third of patients are diagnosed with tumours which have not spread and can be removed by surgery following a course of chemotherapy. However, less than one in five patients show evidence of shrinkage from the chemotherapy when their tumour is removed.”

“In order to cure more oesophageal cancers we need to identify the most effective treatment for each patient to give them the best chance of all of their cancer being removed. At present we apply a ‘one-size-fits-all’ approach where everyone gets the same type of chemotherapy before their surgery. But we know that different chemotherapies work better for different patients so we need to match the right treatment to the right patient. This test enabled us to gain a molecular understanding of each patient’s cancer, which could then inform the decision to select the right chemotherapy to shrink the tumour.”

Queen’s has collaborated with Almac Diagnostic Services to bring personalised medicine to oesophageal cancer. Almac Diagnostic Services has previously developed the DNA Damage Immune Response (DDIR) Signature, previously known as DDRD, to personalise chemotherapy for breast cancer but further studies indicated that it may be applied to other cancer types. The DDIR Signature is a 44 gene signature which uses the expression of each gene present in each tumour to generate a score for each patient. A high score indicates that the tumour has a higher likelihood of responding to DNA damaging chemotherapies.

Professor Richard Kennedy, McClay Professor of Medical Oncology at Queen’s University Belfast and Global Vice-president of Biomarker Development at Almac Diagnostic Services commented: “This study highlights the benefits of close collaboration between academia and industry and the strong links between Queen’s and Almac in particular. It expands the indications for the DDIR signature to oesophageal adenocarcinoma and brings stratified medicine a step closer in this difficult to treat cancer.”

This research study is part of the Oesophageal Cancer Clinical and Molecular Stratification (OCCAMS) consortium led by Professor Rebecca Fitzgerald from the Medical Research Council Cancer Unit at the University of Cambridge and funded by Cancer Research UK.

Professor Fitzgerald commented: “The OCCAMS collaboration is a UK wide network of centres for the collection of tissue samples and clinical information to study the biology and treatment of oesophageal cancer. A key aim of the consortium is to translate laboratory discoveries into clinical progress and this study is an example of using this knowledge to improve diagnosis and treatment for oesophageal cancer patients.”

The research has been published in the prestigious journal Gut, one of the highest ranking gastroenterology journals in the world and is freely available to the research community. The research team is continuing to test the assay further in other sample collections and through clinical trials.

The research paper is available from the journal Gut here.

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Partner with Queen’s Researchers to pioneer potentially life-changing oesophageal cancer test appeared first on Almac.

Almac Group Further Expands Global Analytical Services Capability

admin — Mon, 15 Apr 2019 07:00:18 +0000

Craigavon, N.I., 15 April 2019 – Further to Almac Group’s recent announcement regarding expansion of its global analytical services capabilities, the organisation is delighted to announce additional expansion plans at its Athlone facility.

Currently employing over 150 highly skilled analysts working in GMP / GLP environments from its 3 locations in Craigavon, UK; Athlone, Ireland; and Souderton, Pennsylvania, North America, Almac is positioned as the partner of choice with significant experience in a wide range of analytical services.

In October, Almac’s Sciences Business Unit united its world-class capabilities to form a global analytical group to meet the varying requirements of its clients’ development programs.

As a result of ongoing and increased demand, Almac is now investing significantly in additional laboratory space at its Athlone facility in order to support microbiology and GMP analysis of small and large molecules.

As a result of this expansion, the company will seek to double its existing workforce with up to 40 highly skilled new jobs being created in the next 24 months.

Dr John Robson, Vice President Quality Operations at Almac Sciences, commented:

“When we acquired the Athlone facility in 2017 we recognised a clear potential to expand and develop the highly experienced team to complement our analytical services at our global headquarter campus and facility in the US. Almac is committed to offering a best-in-class service to our global client base and delighted to continue at pace with significant investment across all our facilities in order to strengthen our competitive position in the marketplace.”

Find out more about Almac’s range of analytical services here.

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Further Expands Global Analytical Services Capability appeared first on Almac.

Almac Group Publishes Comparison Report on Automated vs Paper based Accountability & Reconciliation

admin — Mon, 08 Apr 2019 13:00:28 +0000

Cost analysis findings include savings of over $1 million per trial

Souderton, PA, USA, 8 April 2019 – Almac Clinical Technologies, a member of the Almac Group, has today published a report which finds that the use of an automated chain-of-custody system can save a minimum of $1,300,000 per clinical trial in operating costs.

The drug accountability and reconciliation processes are noted for being time-consuming and error-prone, two characteristics that result in contributing significantly to clinical trial costs and timelines. The onerous task of reconciling discrepancies in drug supply records which can accumulate over the course of a trial often adds significant delays to the study close-out phase.

The implementation of drug accountability & reconciliation software eliminates paper-based records, transcription errors and multiple systems that lead to missing data and errors thereby reducing risk to patients, speeding trial close-out and preventing non-compliance errors throughout a clinical trial. However, the assumption has always been that automation can also cuts costs.

In order to quantify this assumed value, Almac Clinical Technologies sponsored a survey of clinical trial personnel involved in the accountability and reconciliation process to determine the time spent on reconciling supplies, resolving discrepancies at sites and completing close-out activities. The research compared trial sponsors and sites using manual processes against those using electronic (including those applying a hybrid combination of both paper & electronic) processes.

The results reveal that, on average, automation reduces time spent when reconciling supplies by 87% (32 minutes) per drug kit, whilst trimming time spent on close-out activities & reports pertaining to accountability & reconciliation by 35% per trial. Additional average savings of $435,456 per study are made by reducing the time that study monitors / CRAs would be required at clinical sites in order to complete accountability and reconciliation activities.

In total, the survey established the use of an automated drug accountability & reconciliation system can save a company a minimum of $1,300,000 per trial in tangible costs.

Valarie Higgins, President and Managing Director of Almac Clinical Technologies, comments:

“This research not only highlights the key benefits of using an automated drug accountability and reconciliation system compared to a traditional paper-based approach, but also the significant cost savings that could be achieved. We, at Almac, appreciate these finding are incredibly valuable to trial sponsors who are currently considering such an approach and we would be delighted to advise and support companies during this process.”

To read the report and find out more about Almac, visit here.

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Publishes Comparison Report on Automated vs Paper based Accountability & Reconciliation appeared first on Almac.

Almac Group Launches Upgraded Version of claraT – A Unique, Software-driven Gene Expression Report

admin — Wed, 27 Mar 2019 08:00:23 +0000

Now includes six Hallmarks of Cancer to aid Biomarker Discovery

Craigavon, N.I., 27 March 2019 – Almac Diagnostic Services, a member of the Almac Group, will launch its second iteration of clara^T* at AACR in Atlanta on 29 March. The clara^T report is a unique software-driven solution, classifying biologically relevant gene expression signatures into a comprehensive report and classifies using the Hallmarks of Cancer for easy interpretation – saving oncology researchers’ valuable time, whilst maximising the understanding of their dataset.

The new version content now includes 62 gene expression signatures and 60 single gene drug targets, in addition to almost 4,000 other biology linked genes.

The content has expanded from the first three hallmark biologies launched at ESMO 2018: Avoiding Immune Destruction, Activating Invasion and Metastasis and Inducing Angiogenesis. Almac has now enhanced the clara^T report further by upgrading three additional hallmark biologies: Genome Instability & Mutation, Sustaining Proliferative Signalling and Resisting Cell Death. Almac will continue to grow the clara^T report by developing content to eventually cover all 10 Hallmarks of Cancer by the end of the year.

The clara^Treport benefits Academic and BioPharma biomarker discovery and translational research. Clients are provided with an interactive report that allows the easy visualisation of the key discriminating biologies within both the study cohort and an individual tumour sample.

The clara^T report is a pan-cancer solution generated from raw gene expression data, utilising Almac’s RNA-Sequencing Service. RNA-Sequencing data is extremely complex and difficult to interpret, often requiring extensive bioinformatics expertise. Almac has developed proprietary bioinformatics pipelines to report this complex data through clara^T in a simplified manner, helping to save time and maximise the understanding of any dataset more quickly.

Richard Kennedy, Global VP of Biomarker Discovery, Almac Diagnostic Services stated: “Conventionally gene expression signatures are applied individually to classify patients into molecular subgroups. Signatures designed to identify the same biology are often developed independently using different bioinformatics algorithms and therefore may not classify identically.

In order to address this, we developed the clara^T software solution which uses consensus between multiple published and Almac proprietary gene signatures, categorised into the Hallmarks of Cancer, to classify cancers in a more robust manner. Importantly this standardised bioinformatics approach enables the analysis of datasets in a highly reproducible and cost effective offering.”

For further information on clara^T visit almacgroup.com/diagnostics/claratreport.

To discuss your RNA research project requirements and how clara^T can help, visit the Almac stand #3225 at AACR 2019.

*NOTE: The results displayed in the clara^T report are for research use only (RUO) and are not to be used for diagnostic or prognostic purposes, including predicting responsiveness to a particular therapy.

About Almac Diagnostic Services

For more information visit: almacgroup.com/diagnostics.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

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Almac Group Recognised with Six Life Science Leader CMO Awards

admin — Tue, 26 Mar 2019 08:00:59 +0000

Craigavon, N.I., 26 March 2019 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce it has won awards in all core categories for 2019 for excellence in Quality, Reliability, Capabilities, Expertise, Compatibility, and Service.

These awards recognise Almac’s global reputation for excellence built over 50 years of client service across the drug development and commercialisation lifecycle and is the organisation’s seventh consecutive year of winning the awards.

The CMO Leadership Awards recognise top performing CMOs, celebrating outstanding companies in drug development and manufacturing, emphasising high standards of quality, integrity and innovation exemplified in their work. The winners were revealed at a ceremony on 20^th March at Convene at 237 Park Avenue, New York.

ISR’s Contract Manufacturing Quality Benchmarking research is conducted annually via an online survey. For the 2019 CMO Leadership Awards more than 120 contract manufacturers were evaluated on 23 performance metrics. CMOs must meet the minimum threshold of customer survey responses to be eligible for an award.

Graeme McBurney, President and Managing Director, Almac Pharma Services, commented: “I am both delighted and proud that Almac has been consistently recognised by Life Science Leader at the annual CMO awards. Receiving recognition in all six categories reflects our continued efforts to provide best-in-class services to our global client base and these accreditations are especially meaningful as we have been evaluated by customers we have actually worked with.”

The CMO Leadership Awards are an opportunity to showcase companies with outstanding reliability and service capabilities impacting client’s complete drug development lifecycle.

“The value and importance of the Life Science Leader CMO Awards grows each year. No industry awards are more meaningful than these recognizing the highest level of accomplishment as evaluated by actual customers. An award in any of the categories assessed, including capabilities, compatibility, expertise, quality, reliability and service, adds a clear acknowledgement of the leadership provided by the CMO recipient. Our congratulations to all of this year’s CMO Award winners — you keep the industry on the path to further success.” says Louis Garguilo, Chief Editor and Conference Chair, Outsourced Pharma.

To learn more about Almac’s exceptional culture and commitment to quality, please visit our website: https://www.almacgroup.com

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn.

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Almac Group Announces Almac ONE™ – A Unified Clinical Trial Supply Solution

admin — Wed, 06 Mar 2019 07:55:02 +0000

Craigavon, N.I., 6 March 2019 – Almac Group announces Almac ONE™ – providing the first unified Clinical Trial Supply solution. This solution redefines the Clinical Supply Chain experience, creating a responsive end-to-end process that enhances visibility and accuracy throughout the lifecycle of a clinical study.

The drug development market continues to evolve significantly with common challenges such as expensive investigational products, limited inventory and globalization of clinical trials. One of the key challenges facing sponsors today is the disconnect that exists across the clinical supply chain with variable recruitment patterns and patient demand. This leads to disjointed and costly trials resulting in frequently missed milestones.

The consequence of a fragmented approach is that vital study data is not aligned therefore there is a need for much more informed, smart and timely decision making.

Supporting sponsors to fully optimize their clinical supply chain, Almac has harnessed over three decades of experience delivering Clinical Supplies services and Interactive Response Technology to develop Almac One™.

Bringing together expert consultants from across the clinical packaging, logistics and IRT spectrum, the Almac ONE solution provides sponsors with a single set of processes, combined with closed-loop technology to manage data end-to-end, for greater supply chain visibility and control throughout a study’s lifecycle. Almac ONE achieves this by aligning patient recruitment, clinical supply and IRT strategies to deliver a seamless data flow.

Val Higgins, President and Managing Director of Almac Clinical Technologies, comments:

“We understand that our clients conducting complex and global clinical studies are facing increased pressures on time, delivery and agility. In response to these challenges, I am delighted that Almac ONE will provide sponsors with a more streamlined approach to the global supply chain and empowers our clients to make speedier, more accurate decisions to manage their studies. This is the latest development in our ongoing program of solutions that will help our clients face the challenges that the clinical supply chain of tomorrow may bring.”

To find out more about this service, please visit: almacgroup.com/almac-one/

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn.

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Almac Group Engages with Science Exchange to Promote US Small Molecule Analytical Services

admin — Mon, 25 Feb 2019 07:55:49 +0000

Craigavon, N.I., 25 Feb 2019 – Almac Sciences, a member of the Almac Group, has announced a collaboration with Science Exchange, the world’s leading R&D Services Management company. The partnership will offer online access to Almac’s integrated services from development through commercial scale production of active pharmaceutical ingredients to clients worldwide.

Almac Sciences has profiled its service offerings on the Science Exchange website, including the recently announced full suite of analytical services now offered from its European and North American facilities. Employing 150 highly skilled analysts working in GMP / GLP environments, Almac is positioned as the partner of choice with significant experience in the analysis of both small and large molecules and a range of product types including peptides, biologics, conjugates, potents and controlled substances.

Science Exchange was founded in 2011 with the mission of democratising access to the world’s scientific expertise in order to move the research world forward at a faster pace. Science Exchange’s secure online solution to manage R&D services makes it easy for researchers to access the world’s leading scientific service providers and most innovative technologies.

“Science Exchange gives Almac Sciences another avenue where potential clients can find us in a quick and efficient manner,” says Denis Geffroy, VP Business Development, Almac Sciences. “This unique platform will enable us to provide added value across the clinical development lifecycle and help drive our clients to R&D success.”

Elizabeth Iorns, Ph.D., CEO and Co-Founder of Science Exchange, commented, “We are delighted that Almac has chosen to profile its offerings on our marketplace, where researchers from across the globe can readily access details on Almac’s vast range of services. Clients can use our platform to order services directly from Almac under a single, pre-established contract, enabling them to save time and money.”

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About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organization which has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn.

About Science Exchange, Inc.

Science Exchange is the world’s leading R&D Services Management company, empowering research organizations to accelerate science and drive more innovation success.

With a secure online solution to manage the complete R&D services eCommerce workflow, Science Exchange offers more than 7,000 services from a network of over 2,500 qualified research providers. For more information, visit www.scienceexchange.com.

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Almac Group to host Clinical Trial Supply Lunch and Learn Workshop in San Francisco

admin — Wed, 20 Feb 2019 12:55:55 +0000

Souderton, PA, U.S, 20 February 2019 – Almac Clinical Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, is delighted to invite participants from the Biopharma Industry to join its upcoming lunch and learn workshop in San Francisco, CA.

Hosted at Doubletree Suites by Hilton San Francisco Airport North on Wednesday, March 27^th, the complimentary workshop will examine “Clinical Trial Supply and Technology: A proven approach to achieve supply chain harmony”. Leading the workshop will be Almac’s clinical supply experts, including Jacqueline Masker, Supply Chain Manager, Project Leader Cheryl Kole, Director of Technical Solutions, and Andy Ritchey, Supply Chain Manager.

Almac understands the challenges faced by biotechnology and pharmaceutical companies in an ever-changing industry. Using real life case studies and interactive discussion, the workshop will follow the life cycle of the physical clinical supply chain from bulk manufacture to destruction, demonstrating the effective use of integrated digital systems for site, drug and patient management. Attendees will learn how to achieve an optimized and harmonized clinical supply chain as well as discuss how to overcome the barriers posed by the management of clinical supplies.

Workshop speaker, Cheryl Kole, comments on the upcoming event:

“We are excited to be hosting this unique workshop which will give participants an opportunity to understand Almac’s extensive clinical supply capabilities. The primary goal of this workshop is for attendees to leave with a wealth of knowledge on how to execute their trials more effectively based on a solid understanding of having a harmonized physical and digital clinical supply chain.”

As industry leading experts, Almac hopes that the information presented during this complimentary lunch and learn workshop can help to guide clinical supply professionals throughout their clinical supply journey.

To find out more and to sign up, please visit: almacgroup.com/clinical-services/clinical-trial-supply-and-technology-2/

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About Almac Group
A unique culture delivering exceptional solutions

The international company is a privately owned organization which has grown organically over the past five decades now employing over 5600 highly skilled personnel across 17 facilities including Europe, the US and Asia.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn.

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Inspiring the Next Generation Almac Group Promotes STEM Careers at W5

admin — Mon, 18 Feb 2019 12:00:18 +0000

Craigavon, N.I., 18 Feb 2019 – Following the recent launch of W5’s new interactive MED-Lab, in association with Craigavon based Almac Group, year 10 students from post primary schools across Northern Ireland were invited to attend a hands-on Science, Technology, Engineering and Maths (STEM) careers event run in partnership with Almac and the STEM Ambassadors Programme.

The event, run as part of the NI Science Festival 2019 over two days on February 15th and 28th, gives 400 young people an insight into the pharmaceutical industry and the breadth of careers it supports through presentations and speed networking opportunities with STEM Ambassadors from both Almac and QUB.

Dr Frances Weldon, STEM Outreach Manager Almac, said, “Almac is dedicated to sharing its passion about advancing knowledge and interest in STEM subjects to as wide an audience as possible. We want to show young people, in particular, not only the many pathways into a career in Health and Life sciences but also how varied and exciting that career can be. By enabling the students to meet and hear from our employees in a fun and informal way we hope to stimulate the next generation of budding scientists, engineers, mathematicians and technologists.”

MED-Lab aims to enable STEM knowledge and understanding and among W5 visitors of all ages through interactive learning. The only exhibition of its kind in Ireland MED-Lab gives visitors the ability to explore our bodies and enables them to get hands-on with some intriguing interactive exhibits, learning how scientists at Almac discover and develop medicines and diagnostic services tests for patients globally.

ENDS

About Almac Group
A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn.

The post Inspiring the Next Generation Almac Group Promotes STEM Careers at W5 appeared first on Almac.

W5 Opens New MED-Lab Exhibition

admin — Thu, 10 Jan 2019 12:33:24 +0000

Created in association with Almac Group, Ireland’s first attraction to explore human body unveiled

MED-Lab, a new interactive medical themed exhibition area at W5, takes visitors of all ages on an extraordinary and fun journey of discovery into the human body.

The only exhibition of its kind in Ireland, it offers visitors the opportunity to learn about the amazing systems that keep our bodies alive and, by using advanced imaging technologies, see inside the body.

MED-Lab gives us the ability to explore our bodies and enables visitors to get hands on with some intriguing interactive exhibits, learning how the scientists at Almac Group discover and develop medicines and diagnostic tests for patients globally.

This exciting new attraction has been developed by W5 in consultation with local audiences and is funded by the Inspiring Science Fund – a partnership between the Department for Business, Energy & Industrial Strategy (BEIS), UK Research and Innovation (UKRI) and Wellcome. Additional support was awarded by the Almac Group.

The Inspiring Science Fund is a £30 million capital scheme to support science centres across the UK, helping them rethink what they do and what they offer to the public.

Eric Porter, Chair of the Odyssey Trust said: “Enhancing education and scientific knowledge, MED-Lab is an innovative and intriguing investigation into our most prized possession – our body! We are delighted to unveil the first of eight new innovative zones in W5, which we know will be hugely popular with our visitors.”

Alan Armstrong, Chairman and CEO of the Almac Group said: “It is a real privilege to be partners in such an exciting project. As a business employing over 5,000 individuals globally, our success depends on the talent and skills of our most important asset, our people, it is therefore crucial that we continue to invest in the next generation. Almac is dedicated to advancing knowledge and interest in STEM subjects and sharing our rich history and work carried out in the medicine development lifecycle for patients globally. We hope that through MED-Lab combined and with our long term STEM Outreach strategy thousands of young people will be inspired to seek out careers and realise the potential opportunities that exist across Almac.”

MED-Lab aims to enhance STEM (Science, Technology, Engineering and Maths) knowledge and understanding among the next generation of budding scientists through interactive learning. It is now open to W5 visitors inviting them on an interactive and fun learning journey through the human body, with some amazing reveals such as a human bone can be four times stronger than concrete and that there are more than 100,000 Kilometres of blood vessels in the human body.

The new exhibition completed phase one of a refurbishment which will maintain W5’s position as a world class science and discovery centre attracting tourists and people of all ages from Northern Ireland and beyond. In addition to the £1m investment provided by Almac Group, W5’s new Health and Life Sciences partner as part of a 10 year agreement, there is a £4.5m capital investment package for W5 refurbishment during 2019-2020. £3m funding was awarded through the Inspiring Science Fund and a further £1.5m invested by the Odyssey Trust.

To find out more about MED-Lab and W5 visit www.w5online.co.uk

Ends

For more information contact Teri Kelly at teri@kellypr.co.uk or on 07957142915 or Gary Kelly at gary@kellypr.co.uk or on 07581282723.

Notes to editors

About W5

W5 opened on the 30th March 2001 and has attracted over 3.5 million visitors. W5 has over 250 interactive exhibits spread over five levels. The building also contains Climbit – a multi-story climbing structure, Space-base – a multi-sensory activity zone, a lecture theatre, a temporary exhibition space and ancillary facilities including a shop and café. During 2017/18 W5 attracted 270,000 visitors, which included 30,000 pupils on formal education school visits.

About Almac Group

Inspiring Science Fund

The Inspiring Science Fund is a £30 million capital scheme to support science centres across the UK, helping them rethink what they do and what they offer to the public.

The aims of the fund are to revitalise the offer of existing science centres through capital development, such as new exhibition spaces and learning centres, and the opportunity to develop meaningful and inclusive engagement with under-served and underrepresented audiences, engaging and inspiring new visitors. This opportunity to refresh how science centres are operating will lead to more sustainable business models and contribute to science centre sector development through shared learning.

The scheme is co-funded by UK Research and Innovation (UKRI) and Wellcome.

Wellcome

Wellcome exists to improve health by helping great ideas to thrive. We support researchers, we take on big health challenges, we campaign for better science, and we help everyone get involved with science and health research. We are a politically and financially independent foundation.

UKRI

UK Research and Innovation (UKRI), the new funding organisation for research and innovation in the UK, succeeded The Department for Business, Energy and Industrial Strategy (BEIS) as co-funder of the Inspiring Science Fund in 2018. UKRI brings together the 7 UK research councils, Innovate UK and a new organisation, Research England, working closely with its partner organisations in the devolved administrations.

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Galen Appoints Dr Dennise Broderick as Managing Director

admin — Tue, 08 Jan 2019 08:55:39 +0000

Craigavon, N.I., 8 January 2019 –Galen Ltd, the Northern Ireland based pharmaceutical company, is delighted to announce the appointment of Dr Dennise Broderick as its new Managing Director and President. She will report to Alan Armstrong, CEO and Chairman, Almac Group, – the parent company of Galen Ltd.

Together with Almac Group’s Board of Directors, Dennise is responsible for all aspects of the specialist pharmaceutical company’s operations, marketing and governance across its sites throughout Europe and the US.

Dennise is a highly successful, respected and inspiring Executive Business Leader, with an extensive career within the pharmaceutical industry. Most recently Dennise held the position of Country Manager, leading the Irish affiliate of IPSEN Pharmaceuticals and was responsible for all aspects of the business. Prior to this Dennise also held CEO/MD and senior leadership roles with Pfizer, Hospira, Zeneus, Viatris and other pharmaceutical companies both in Ireland and Europe.

Dennise is also very highly respected academically and remains on the invite list as a guest lecturer within the National Universities of Ireland having previously lectured part-time within their network.

Mr Armstrong, commented on Dennise’s appointment: “We are delighted to welcome Dennise to our team. Her inside knowledge of the industry will be instrumental in developing the Galen brand and growing the company globally. Her inspiring approach will be sure to help us meet our ambitious targets and look forward to an exciting future.”

Dr Broderick added, “It is an honour for me to join the Galen team and look forward to working with the established global management team to strengthen our vision to make Galen a successful global pharmaceutical company with a strong focus on both the customer and the patient. It’s an exciting challenge, one which I am looking forward to immensely.”

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About Galen

Established in 1968, Galen is a privately owned pharmaceutical sales and marketing company, headquartered in Craigavon (Northern Ireland), with products in therapy areas including gastroenterology, urology, female health, pain management and mental health.

Visit: www.galen-pharma.com

About Almac Group

A unique culture delivering exceptional solutions

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 17 facilities including Europe, the US and Asia. Click here to view our facilities.

To keep up to date with our latest news, follow us on Twitter and LinkedIn.

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Almac Group Flows into Continuous Technology

admin — Tue, 08 Jan 2019 01:10:20 +0000

Craigavon, N.I., 8 January 2019 – Almac Sciences, a member of the Almac Group, has expanded its technology capabilities within its Active Pharmaceutical Ingredients (API) services & chemical development portfolio with the implementation of continuous flow expertise at its global headquarters in Craigavon, UK, with further plans to introduce flow capacity within Arran Chemical Company (Athlone, Ireland).

Continuous flow manufacture is an innovative technology platform which is gaining momentum within the pharmaceutical industry with the FDA supporting the adoption for the manufacture of APIs. It offers significant improvements in relation to product quality, process safety, reduction in plant footprint and provides the ability to perform chemistry that is difficult or impossible to do in batch mode.

Almac Sciences has a 4-year strategy to develop Flow Assisted Synthesis Technology (FAST) focusing on four key areas; (1) high pressure hydrogenations, (2) high energy chemistry, (3) oxidation and (4) photo-redox LED mediated chemistries. To support this, Almac Sciences has been awarded a Knowledge Transfer Partnership from Innovate UK for the development of novel routes to chiral amines using flow technology. In addition, Arran Chemical Company, in partnership with Queen’s University, Belfast, has been successful in securing a Horizon 2020 funded programme to support 4 PhD studentships for the next 4 years (beginning in 2019) in line with the FAST strategy.

Almac will develop highly flexible, robust, efficient flow technology platforms for continuous manufacture for the benefit of its clients who seek high quality and best-in-class pharmaceutical synthesis.

Prof. Tom Moody, VP Technology Development & Commercialisation, Almac & Arran Chemical Company commented, “The introduction of continuous flow technology further enhances Almac Sciences’ capabilities within API development and manufacture. Flow technology is highly flexible, robust, economic and regarded as the most exciting and innovative growth technology for the preparation of APIs. We are delighted to now offer this within our portfolio and will strive to continue providing world-class solutions to advance human health globally.”

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About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn

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Almac Group Launches Second Line for High Throughput GMP Peptide Manufacturing

admin — Wed, 02 Jan 2019 09:51:01 +0000

Craigavon, N.I., 2 Jan 2019 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce that they have brought online a second stream for High Throughput GMP Peptide manufacturing.

The High Throughput GMP Peptide facility, based in Edinburgh, Scotland, manufactures neoantigen derived peptides for use in the production of patient specific, individualised cancer vaccines.

Almac has been active in High Throughput manufacturing of neoantigen derived peptides – branded by Almac as NeoPeptides™ – for several years. The NeoPeptides™ facility underwent a conversion from non GMP to GMP through 2018 and has been operating in full GMP mode since September. The facility has undergone a successful MHRA inspection and has now moved into routine GMP supply. Demand for Almac NeoPeptides™ is growing strongly and, in response, the company has moved quickly to bring online a second GMP manufacturing line.

Speed is critical within the field of individualised cancer vaccines and the entire supply chain is focused on minimising the time between the initial patient biopsy and the ultimate vaccine administration. Almac Sciences’ NeoPeptides™ offering is built upon Almac’s track record in high speed manufacturing of peptides from its Edinburgh facility. The key which has enabled Almac to convert this technical competence into High Throughput GMP manufacturing has been the creation and implementation of a bespoke Pharmaceutical Quality System, designed specifically to enable high speed, fully compliant GMP manufacturing. The company can already stand on its track record; in the first eight weeks of GMP operation the facility manufactured and released >80 GMP peptides.

Dr Charles Shields, Vice President Peptides and Small Molecule API commented “Almac’s decision to bring a second GMP NeoPeptides™ manufacturing stream online so quickly after the first is a clear statement of our commitment to the field of individualised cancer vaccines. We understand this market well and intend to maintain our world leading supply position on neoantigen derived peptides. We will be announcing further expansions of our facility and our service offering in the coming months.”

Neoantigen derived vaccines have become a major new strategy within oncology as researchers look to harness the body’s own immune system to fight cancer. The treatment platform is completely individualised. A patient’s tumour is biopsied and genetically sequenced to identify the epitope mutations which are present within the patient’s cancer. These neoepitopes are completely unique to that patient and their tumour. The neoepitopes are then replicated within a series of peptides – typically 10-30. The peptides are manufactured within Almac’s High Throughput GMP manufacturing facility, they are then formulated into a patient-specific cancer vaccine and administered to the patient. Each peptide manufacture is unique; manufacture occurs once and the product is administered to only one patient.

#END#

About Almac Group
A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Invites Attendees to Join Workshop in San Diego to Learn About Cold Chain Management in Clinical Trials

admin — Fri, 14 Dec 2018 01:55:14 +0000

Souderton, PA, U.S., 14 December 2018 – Almac Clinical Services, part of the global contract pharmaceutical development and manufacturing organisation the Almac Group, is pleased to invite participants from the pharmaceutical and biopharma industries to join its San Diego lunch and learn to discuss cold chain management in clinical trials.

The complimentary event will be held at the NINE-TEN Restaurant & Bar in San Diego, CA on Wednesday, January 30^th from 11:00 am to 2:00 pm. Two of Almac’s subject matter experts, Bryan Thompson and Mark Clayton, will deliver a presentation entitled Playing it cool – cold chain solutions for your clinical supply chain. The presentation will examine challenges faced with a temperature controlled clinical supply chain, and aims to educate attendees on choosing appropriate packaging, labelling, storage, and distribution for temperature sensitive clinical trial materials.

Almac Clinical Services Production Manager and presentation speaker, Bryan Thompson, comments on the upcoming lunch and learn:

“I am excited to be sharing my knowledge on this important topic. The primary goal of this presentation is for attendees to gain insight on how to execute their clinical trials more effectively based on a solid understanding of managing temperature controlled materials.”

With an increase in biologics and biosimilar type drugs being trialed, there is an increase in demand for cold chain management solutions in order to handle the packaging, labeling, storage and shipping of refrigerated and frozen product.

As industry leading experts, Almac understands the challenges faced by its customers regarding temperature control of clinical trial materials, and hopes that the information presented during this complimentary event can help to guide clinical supply professionals throughout their clinical supply journey.

Almac Group hopes that this workshop, as well as future workshops, will continue to aid customers in increasing their knowledge around global clinical trial supply services, and to provide them with additional networking opportunities.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Clinical Services Wins Excellence Awards at 2018 Cold Chain Global Forum

admin — Wed, 07 Nov 2018 12:45:13 +0000

Craigavon, N.I., 07 November 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is pleased to share that temperature-controlled packaging suppliers Cold Chain Technologies and Almac Clinical Services were recently announced as winners of the “Global Forum Excellence Awards for Best Innovative Supply Chain Strategy” and “Best Supplier Collaboration” at the 16th Annual Cold Chain Global Forum in Philadelphia, PA.

The selection of these companies was based on developing and implementing the Almac Pod™ Program: an innovative reusable small parcel temperature-controlled shipper and accompanying qualified refurbishment program. With Almac’s help, the companies co-created a high-performing shipping solution managed by a robust and repeatable refurbishment process, resulting in a program that has enabled increased throughput, improved program costs, enhanced temperature protection duration, weight reductions and reduced waste.

Leon Supplee, Director of Logistics, commented, “I am delighted to accept these awards on behalf of Almac Clinical Services and in conjunction with Cold Chain Technologies. The Almac Pod™ Program resulted from close and continuing collaboration between our organizations and we are very pleased with the outcome and ongoing benefits.”

“We are very pleased to receive these awards at the Cold Chain Global Forum. This represents important recognition among our peers of the value and effectiveness of the Almac Pod™ Program, as well as how this reusable shipping solution and refurbishment program results in real operational benefits to organizations like Almac Clinical Services,” said Anthony Rizzo, Senior Vice President at Cold Chain Technologies.

Cold Chain Technologies is a leading global provider of single-use and reusable thermal packaging solutions for the distribution and transport of temperature-sensitive shipments. The company is ISO 9001:2015 registered, with over 50 years of ensuring product safety for the pharmaceutical, life science, and food service industries.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn.

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Inaugural Almac McKervey Award Presented for Excellence in Chemistry

admin — Thu, 25 Oct 2018 07:30:46 +0000

Craigavon, N.I., 25 October 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is delighted to announce that the first ‘Almac McKervey Award’ for Excellence in Organic Chemistry has been awarded.

The award, a commemoration to the life and work of one of Ireland’s most distinguished scientists, Professor Tony McKervey, who passed away in June 2017, was made to Queen’s University Belfast Medicinal Chemistry student, Eilish Bonner.

Eilish, who is originally from Dungloe in County Donegal, was presented with the award by Dr Stephen Barr, Managing Director, Almac Sciences. She also received a £1,500 bursary towards her tuition fees and a 12 month placement with Almac to gain industry experience and mentorship.

Born in Ederney, Co Fermanagh in 1938, Tony earned a degree in Chemistry from Queen’s University Belfast in 1961. A former Professor of Organic Chemistry at both University College Cork and Queen’s University Belfast, Tony founded Almac’s Sciences Business Unit in 1992 and continued to support Almac as a member of the Sciences’ senior management team until his death at the age of 78.

Dr Barr said: “We chose to name an award after our esteemed colleague and friend, Tony, as a fitting tribute to someone whose leadership, exemplary work ethic and kind demeanour inspired many of us during his long service with Almac. Tony was committed to supporting students with a shared passion for science and this award is designed to support outstanding achievement in organic chemistry, something that our panel of experts felt strongly was exemplified in Eilish’s dedication to her studies.”

Eilish commented: “I am delighted and honoured to accept this prestigious award – particularly in its first year. I have enjoyed my degree at Queen’s thus far and am excited to be gaining hands on experience during my placement at Almac and working alongside so many chemistry experts. Professor McKervey was such an inspiration to students and I am humbled to receive an award in his name.”

“Queen’s is very proud of its long tradition of working with great companies, many like Almac, who employ outstanding QUB graduates from the sciences.” Commented Professor Mark Price, Pro-vice Chancellor for the Faculty of Engineering and Physical Sciences. “It is lovely to see an outstanding student like Eilish be recognised for her achievements through the generosity of this award, given in the honour of one of our most renowned graduates in the sciences. The stars of the past are helping to shine a light on the stars of the future!”

Following the ceremony, Professor McKervey’s daughter, Henrietta, unveiled a perpetual commemorative wall plaque at the David Keir building at Queen’s University – a replica of which has been erected in Almac’s global headquarter facility in Craigavon.

The Almac McKervey Award, which is open to students studying Chemistry or Medicinal Chemistry at the School of Chemistry and Chemical Engineering, Queen’s University Belfast, will be presented each year to the top applicant, selected on both their academic achievement and performance at an interview with Almac’s chemistry experts.

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About Almac Group

A unique culture delivering exceptional solutions

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Almac Group Receives Board of Trade Award by the United Kingdom’s Department of International Trade (DIT)

admin — Thu, 25 Oct 2018 01:00:32 +0000

Craigavon, N.I., 25 October 2018 – Almac Group, the global contract development and manufacturing organisation, is pleased to receive the UK’s Board of Trade Award, presented by the UK’s Department of International Trade (DIT) during its “International Trade Day” held aboard the Royal Navy’s HMS Queen Elizabeth in New York.

International Trade Secretary, Dr Liam Fox MP, hosted a series of events on Monday 22^nd October aimed at strengthening ties with the US, which took place days after US Treasury Secretary, Robert Lighthizer, announced that the US intends to begin negotiations towards a UK-US Free Trade Agreement after the UK leaves the European Union.

A number of British companies were presented with prestigious Board of Trade Awards by the Secretary of State alongside the Almac Group, recognising their successful export activity. Winners of the Board of Trade Awards come from a broad range of sectors, including life science, space and food & drink, representing the best of British innovation and entrepreneurship.

Mark Weir, US Group Financial Controller, commented: “We are deeply committed to honouring our historic roots by reinvesting in our core asset – our employees – for their work and expertise concentrated in Northern Ireland and internationally. As we celebrate our fiftieth year of business, we wish to thank DIT for continuing to place focus on a strong UK-US partnership, positioning Almac to successfully execute on its mission of ‘partnering to advance human health’.”

According to DIT, trade between the UK and the US totalled more than £180 billion in the year to June 2018, making the US the UK’s largest single nation trading partner and export market. Similarly, Almac reported a 19% rise in revenue in June, marking the first time turnover surpassed £500 million, following continued investment in expansion projects with the building of additional facilities and the construction of one of the largest pharmaceutical cold store facilities in Europe at its Global Headquarters in Craigavon, Northern Ireland.

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About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com

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Almac Group Scoops Research & Development Achievement at 2018 Irish Pharma Industry Awards

admin — Wed, 24 Oct 2018 13:31:10 +0000

Craigavon, N.I., 24 October 2018 – Following the success of picking up last year’s ‘Export Achievement’ award, Almac Group, the global contract development and manufacturing organisation, is delighted to announce it has won the Research & Development Achievement Award during this year’s Irish Pharma Industry Award ceremony. This award recognises the company’s commitment to delivering the highest quality R&D services to its global clients.

An independent panel, which comprised 14 industry leaders, judged the entries and determined the winners based on a number of key attributes. Almac’s entry was selected as the winner due to its highly effective and innovative selectAZyme™ research programme which offers green, economic, robust, scaleable and reliable processes for synthesis of chiral APIs and intermediates. It was one of 24 awards presented during the event.

“We are honoured to receive the Research and Development award which once again showcases the successful integration of the diverse and highly skilled technical workforce of Almac and Arran.” Commented Dr Stephen Barr, Managing Director, Almac Sciences. “This award serves to highlight our team’s dedication and commitment to quality and also showcases our ability to solve complex technical challenges. We’re grateful for this award and look forward to drive further success with our continued focus on a range of R&D programmes.”

Since launching in 2014, the Pharma Industry Awards recognise the successes and achievements of Ireland’s pharmaceutical industry and are seen as the benchmark for excellence for those operating within the sector. The winners were revealed at a Gala Awards dinner on 23rd October at The Clayton Hotel, Dublin.

Additionally, Almac Clinical Services’ team was a shortlist-nominee for the Supply Chain Achievement Award, which spotlighted their success with having extensive global coverage and expertise in servicing end-to-end supply chain management.

The Pharma Industry Awards celebrates individuals and companies who most distinguish themselves and demonstrate a commitment to innovative solutions and exemplary quality in the Irish Pharma sector. Ranging from process and formulation to contract-development and manufacturing services, these awards allow recipients to showcase their strengths and annual investments. Almac last received the R&D achievement award in 2014 for its work on Almac Diagnostic Services’ proprietary DNA Damage Repair Deficiency (DDRD) test which helps predict which breast cancer patients are likely to benefit from chemotherapy based on their genetic make-up.

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About Almac Group

‘Partnering to Advance Human Health’

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn

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TP Therapeutics and Almac Diagnostic Services Enter into Agreement to Develop Next-Generation Sequencing, Pan-Cancer Companion Diagnostic

admin — Wed, 24 Oct 2018 00:08:55 +0000

New Diagnostic Assay Intended to Identify Patients with ROS1, NTRK or ALK Gene Fusions for Treatment with TP Therapeutics’ Investigational Drug, Repotrectinib

San Diego, CA, October 24, 2018 – TP Therapeutics, a clinical-stage precision oncology company developing novel drugs that address treatment resistance, and Almac Diagnostic Services, a global precision medicine company, today announced a global collaboration agreement to develop and commercialize a next-generation sequencing (NGS) companion diagnostic (CDx) for repotrectinib, TP Therapeutics’ investigational therapy rationally designed to target ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors.

Under the agreement, Almac will develop the NGS diagnostic based on the ArcherDx’s Anchored Multiplex PCR (AMP™) chemistry, with the intent of submitting it for regulatory approval in the United States. The companion diagnostic will initially allow Almac’s CLIA-accredited laboratory in Durham, N.C. to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.

“Almac provides us with deep experience in the development and regulatory approval of next-generation sequencing diagnostic assays, which will enable the selection of patients who may not otherwise have access to a targeted therapy like repotrectinib,” said Dr. J Jean Cui, founder, president and chief scientific officer of TP Therapeutics. “We look forward to working with Almac to co-develop repotrectinib with a next generation sequencing based companion diagnostic that detects the presence of ROS1, NTRK1-3 and ALK gene fusions.”

“Molecular testing is critical to identifying patients most likely to benefit from a targeted treatment,” said Paul Harkin, managing director, Almac Diagnostic Services. “We have great expertise in the development of biomarker assays across a wide range of technologies and targets, with an extensive track-record in developing and validating assays under design control and according to regulatory requirements. We are very pleased to work with TP Therapeutics on such a promising investigational therapy as repotrectinib.”

Co-development of CDx and therapeutic products is critical to the advancement of targeted therapies and precision medicine. Companion diagnostics are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients, based on the individual molecular characteristics of each person. Incorporating a companion diagnostic strategy into a drug development program may help generate more effective treatments with improved safety profiles for patients.

The financial terms of the agreement were not disclosed.

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About Almac Diagnostic Services

For more information visit: almacgroup.com/diagnostics.

About Repotrectinib (TPX-0005)

Repotrectinib (TPX-0005) is a potent and orally bioavailable investigational small-molecule inhibitor of ALK, ROS1 and TRK family kinases. The clinical benefits of targeting ALK, ROS1 or TRK fusion kinases have been demonstrated with multiple kinase inhibitors already approved for the treatment of ALK+ non-small cell lung cancer (NSCLC), in addition to crizotinib for ROS1+ NSCLC, and larotrectinib and entrectinib in clinical studies for TRK+ cancers. The successes of these therapies are overshadowed by the development of acquired resistance. The acquired solvent front mutations including ALK G1202R, ROS1 G2032R, TRKA G595R and TRKC G623R render a common clinical resistance to the current ALK, ROS1, and TRK inhibitors. Repotrectinib has demonstrated potency against wildtype and mutated ALK, ROS1 and TRK family kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple lines of treatment. Repotrectinib may provide a new opportunity to inhibit the abnormal signaling of ALK, ROS1, or TRK family kinases in solid malignancies, and overcome multiple resistance mechanisms seen in refractory patients. Repotrectinib is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1 study, www.clinicaltrials.gov number NCT03093116). Interested patients and physicians can contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email clinical@tptherapeutics.com.

1Note: TPX-0005 had an initial generic name of “ropotrectinib,” which was later changed to repotrectinib and is now the accepted name by USAN and WHO INN.

About TP Therapeutics Inc.

TP Therapeutics is a clinical-stage precision oncology company forging a new path for targeted cancer care. Founded in October 2013 by Dr. J. Jean Cui, the lead inventor of Pfizer’s oncology drugs crizotinib and lorlatinib, the company is developing a pipeline of novel drugs that aim to tackle treatment resistance and give new hope to patients who have stopped responding to available targeted therapies. Mounting clinical data for the company’s lead program, a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors, has shown ongoing antitumor activity and durable responses among treatment-naïve and pre-treated patients. With additional programs underway to address similarly intractable oncogenic drivers, TP Therapeutics is marking a turning point in the way solid-tumor cancers are treated. For more information, visit www.tptherapeutics.com.

TP Therapeutics Investor and Media Contact:

Jason Spark

Canale Communications

619-849-6005

jason@canalecomm.com

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

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Almac Group Announces Successful HSA Inspection of Singapore Facility

admin — Mon, 22 Oct 2018 06:55:42 +0000

Craigavon, N.I., 22 October 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is pleased to announce it has received a renewal of its GMP/GDP certification following the successful regulatory inspection by the Health Sciences Authority (HSA) of its facility in Singapore.

The organisation’s Asia Pacific headquarters and clinical trial supply facility was first established in Singapore in 2015 and vastly expanded Almac’s range of unique solutions offered from within the region to further optimise the clinical supply chain for both global and regional studies in their customers’ own language and time zones. This accreditation was awarded after an on-site 3 day inspection held in June 2018 confirming Almac’s compliance with the HSA standards of safety, quality and efficacy across its various operations.

Almac has continued to invest in and strengthen its in-region capabilities which are a key part of its ongoing global expansion strategy to meet market and patient needs. As part of this strategy, the facility has seen a 40% uplift in business volume, which has led to the creation of further permanent jobs at our Singapore and Japanese facilities in support of this increased demand. The successful inspection strengthens Almac’s commitment to directly support sponsors conducting regional and global studies by providing clinical manufacturing, packaging, storage, distribution, supply chain management and Interactive Response Technology (IRT).

Paul O’Connor, Global VP Quality, Almac Clinical Services, said: “Almac was the first full service clinical trial packaging and distribution organisation to ever receive GMP certification in this region when we opened our Asia-Pacific Headquarters just 3 years ago. We are delighted to receive today’s official certification which is testament to the quality and skill of our employees. We recognise the global scope, relevance and impact of our sphere of work. This successful inspection echoes our commitment to be a world leader on quality and service wherever we do business.”

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‘Partnering to Advance Human Health’

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Almac Group Launches claraT – A Unique, Software-driven Gene Expression Report

admin — Fri, 19 Oct 2018 06:55:58 +0000

Craigavon, N.I., 19 October 2018 – Almac Diagnostic Services has launched clara^T – a unique software-driven solution, classifying biologically relevant gene expression signatures into a comprehensive, easy-to-interpret report.

The clara^T report will benefit BioPharma and Academic biomarker discovery and translational research. Clients are provided with an interactive report that allows the easy visualisation of the key discriminating biologies within both the study cohort and an individual tumour sample.

clara^T classifies relevant published gene expression signatures, alongside Almac’s own proprietary assays and single gene targets linked to multiple key biologies, according to the well-established 10 Hallmarks of Cancer. The clara^T report is a pan-cancer solution generated from raw gene expression data, utilising Almac’s RNA-Sequencing Service.

RNA-Sequencing data is extremely complex and difficult to interpret, often requiring extensive bioinformatics expertise. Almac has developed proprietary bioinformatics pipelines to report this complex data through clara^T in a simplified manner, helping to save time and maximise the understanding of any dataset more quickly.

The clara^T report classifies using the Hallmarks of Cancer for easy interpretation. Initial launch content includes 35 gene expression signatures and 30 single gene drug targets (in addition to other biology linked genes). The first three featured hallmark biologies included are: immuno-oncology (IO), epithelial to mesenchymal transition (EMT) and angiogenesis. Almac will continue to expand the clara^T report by developing content to ultimately cover all 10 Hallmarks of Cancer.

Michael Sloan, Global VP of Commercial Operations, Almac Diagnostic Services stated:

“RNA-Sequencing produces vast amounts of complex raw data that can be difficult to interpret. We believe clara^T offers a unique and highly cost-effective solution to this problem for BioPharma clients. From a single tumour sample sent to Almac’s labs, clara^T provides multiple biologically relevant signature readouts in an easy to interpret report, saving time and allowing researchers to identify key patterns of gene expression within their cohort.

“clara^T further enhances Almac Diagnostic Services’ capabilities within RNA expression profiling. The value of RNA alongside DNA in stratified medicine is slowly starting to be realised and Almac are hoping to provide further proof of its importance with our clara^T gene expression report.

We are excited by the potential effect clara^T may have for future oncology biomarker discovery research.”

For further information on clara^T visit the almacgroup.com/diagnostics/claratreport

About clara^T Report

The results displayed in the clara^T report are for research use only (RUO) and are not to be used for diagnostic or prognostic purposes, including predicting responsiveness to a particular therapy.

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specialising in biomarker driven clinical trials. The company is focused on the discovery, development and commercialisation of diagnostic and companion diagnostic tests. We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics.

About Almac Group

A unique culture delivering exceptional solutions

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Almac Group Invests in Cutting Edge Next Generation Sequencing Capabilities for Bio Pharma Clients

admin — Thu, 11 Oct 2018 06:55:15 +0000

Craigavon, N.I., 11 October 2018 – Almac Diagnostic Services, a global stratified medicine company specialising in biomarker driven clinical trials, has made a significant investment in a new Illumina NovaSeq 6000 sequencer which will benefit Biopharma clients’ biomarker discovery and clinical trial projects.

The addition of the NovaSeq’s powerful processing capabilities to Almac’s existing range of NGS platform offerings allows for larger sample runs, greater read depth and faster speeds. The new instrument will ultimately reduce sample turnaround times and increase variant detection quality and accuracy for clients.

With the NovaSeq, Almac will be able to sequence the transcriptomes of up to ~384 samples, per run (dual flow cell, 50M reads per sample) in a timeframe as short as 36 hours. The NovaSeq provides scalable throughput and flexibility for virtually any sequencing method, genome, and scale of project. To accommodate NovaSeq’s high capacity and efficiency, Almac has also invested in appropriate informatics infrastructure and installed high speed uplinks to cloud based providers.

The NovaSeq will form an integral part of Almac’s current DNA and RNA Sequencing offerings and future offerings for Whole Genome Sequencing (WGS) and Whole Exome Sequencing (WES). Almac Diagnostic Services already has extensive expertise in Next Generation Sequencing (NGS) technology and Bioinformatics. The company offers a customisable solution that allows clients to tailor their diagnostic requirements across multiple platforms and chemistry options to suit their specific translational research or clinical trial needs.

Michael Sloan, Global VP of Commercial Operations, Almac Diagnostic Services said: “We are excited about the potential benefits the NovaSeq will be able to bring to our customers with its sequencing capabilities enhancing our current DNA and RNA NGS panel offerings to the market. We are positioning ourselves at the cutting edge of NGS diagnostics and the investment in this new NGS platform will help Almac to continue to play a leading role within stratified medicine.”

The NovaSeq will also support Almac Diagnostic Services new unique gene expression report, clara^T, which will be launched to market at ESMO 2018 in Munich in October. clara^T is a unique software-driven solution, classifying biologically relevant gene expression signatures into a comprehensive, easy-to-interpret report for cancer research / biomarker discovery.

For more information on Almac Diagnostic Services DNA and RNA NGS Panels offerings go to: https://www.almacgroup.com/diagnostics/clinical-trial-solutions/

For more information and to register an interest in Almac’s upcoming clara^T gene expression report:

https://www.almacgroup.com/diagnostics/clarat-total-mrna-report/

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About Almac Diagnostic Services

For more information visit: almacgroup.com/diagnostics.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn

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Almac Group Invests to Expand its Existing North Carolina Facility

admin — Wed, 10 Oct 2018 00:55:50 +0000

Souderton, PA, US, 10 October 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, today announced the completion of an investment in its Durham, North Carolina Clinical Services’ and Diagnostic Services’ capabilities with the opening of a 24,000 sq. ft. building.

As part of Almac’s ongoing growth strategy, this significant expansion adds a fourth building to the Durham campus and provides additional office space for more than 100 new employees over the next three years. This additional capacity complements Almac’s existing Durham facility which offers a range of end-to-end clinical trial supply solutions to clients globally, as well as Almac Diagnostic Services which provides biomarker driven clinical trial solutions.

Donna Christopher, Global Vice President of Operations, Almac Clinical Services, commented:

“Almac’s exceptional quality is demonstrated by our dedicated employees, all of whom work hard to strengthen relationships for long-term collaboration. We are delighted that this further investment in our Durham facilities enables us to continue to support our clients’ needs and meet the increased demands for our integrated services. This expansion not only provides us with a stronger ability to service our growing customer base but it also serves to demonstrate our commitment to being the most trusted and stable name in the clinical supply marketplace.”

This expansion of service capacity comes shortly after the conclusion of Almac’s previous $5.2 million investment at the North Carolina facility in 2016, which saw the expansion of its Clinical Services operations along with the development of its Diagnostic Services and Clinical Technologies services. In its fifth decade of operations – with over twenty of these in North America – Almac’s commitment to be the partner of choice providing an array of innovative clinical solutions worldwide continues with ongoing expansion plans in development.

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About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Announces Successful HPRA Inspection at its European Campus

admin — Tue, 02 Oct 2018 06:55:02 +0000

Craigavon, N.I., UK, 02 October 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is pleased to announce the successful inspection of Almac Pharma Services (Ireland) at its European campus in Dundalk, Ireland, by the Health Products Regulatory Authority (HPRA).

Almac Group previously confirmed that the premises secured in Dundalk as part of its ongoing global expansion strategy were successfully inspected by the HPRA in January 2018. This initial inspection provided Almac with the regulatory approvals to conduct QP certification of both clinical and commercial drug product from its European campus in Dundalk.

Since January, Almac has made an investment of £10 million to establish state-of-the-art analytical laboratories and commercial packaging suites to ensure current and future client needs within the European Union are met.

This recent inspection by the HPRA now enables Almac Pharma Services to support analysis of commercial drug product and provide flexible secondary labelling and packaging solutions for a wide range of finished pack presentations. Ian Markwell, VP of Quality, commented “We are extremely pleased with this inspection outcome. Not only does this illustrate the strength of our Global Quality Management System but provides assurance to our client partners that we meet all EU regulatory requirements.”

Graeme McBurney, Managing Director, Almac Pharma Services, commented: “This is a great achievement and reflects Almac’s commitment to provide our global client partners with an uninterrupted service provision and seamless access to the EU marketplace. Regardless of the outcome of Brexit negotiations, we look forward to providing best in class, bespoke packaging solutions, from this new European facility.”

Ends

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

Almac would like to acknowledge and thank all those organisations who have provided support over the last 50 years including Danske Bank, Invest NI, PWC and IDA.

To keep up to date with our latest news, follow us on Twitter and LinkedIn.

The post Almac Group Announces Successful HPRA Inspection at its European Campus appeared first on Almac.

Almac Group Launches Global Analytical Services Capability

admin — Mon, 01 Oct 2018 06:55:18 +0000

Craigavon, N.I., 01 Oct 2018 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce its global analytical services capabilities spanning UK, Europe and North America.

Following the successful acquisition of BioClin Research Laboratories in 2017, Almac’s Sciences Business Unit has united its world-class capabilities to form an analytical group which can meet the varying demands required within its clients’ development programs. From 1^st October, BioClin will rename under the Almac Sciences brand, further strengthening its offering and presenting a unified platform within the pharmaceutical industry.

Employing 150 highly skilled analysts working in GMP / GLP environments from its 3 locations in Craigavon, UK; Athlone, Ireland; and Souderton, Pennsylvania, North America, Almac is positioned as the partner of choice with significant experience in the analysis of both small and large molecules, and a range of product types including peptides, biologics, conjugates, potents and controlled substances.

In order to satisfy client demand, resource at Almac’s PA based facility has also increased by 30%. The 2,500 sq ft laboratory provides GMP analytical support to the pharmaceutical industry including analytical method development and validation, GMP stability studies and clinical and commercial product release.

Dr Stephen Barr, President & Managing Director of Almac Sciences, commented: “We are excited to present to the industry a unified analytical offering to our clients under the Almac name. The investments we continue to make highlights the commitment we have to our global client base to meet their growing clinical and commercial requirements.”

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

Almac would like to acknowledge and thank all those organisations who have provided support over the last 50 years including Danske Bank, Invest NI, PWC and IDA.

To keep up to date with our latest news, follow us on Twitter and LinkedIn.

The post Almac Group Launches Global Analytical Services Capability appeared first on Almac.

Almac Group to host Clinical Trial Supply Lunch and Learn at North American Headquarters

admin — Mon, 10 Sep 2018 01:00:21 +0000

Souderton, PA. U.S., 10 September 2018 – Almac Clinical Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, is delighted to invite participants from the Biopharma Industry to join its fourth consecutive North American and seventh global “lunch and learn” seminar this year, building on its unique global knowledge share series.

Hosted at Almac’s North American headquarters in PA on Thursday, September 27^th, the complimentary seminar will examine “Clinical Trial Supply and Technology: A proven approach to achieve supply chain harmony”. Leading the seminar will be Almac’s subject matter experts, including Andy Thress, Supply Chain Manager, Cheryl Kole, Director of Technical Solutions, and Luke Moyer, Supply Chain Solutions Manager.

Almac understands the challenges faced by Biotechnology and Pharmaceutical companies in an ever-evolving industry. Using real life scenarios and interactive group discussion, participants will learn how to achieve an integrated, simplified and optimized clinical supply chain as well as discuss how to overcome the barriers posed by the management of clinical supplies.

Seminar speaker, Luke Moyer, comments on the upcoming seminar:

“We are excited to be continuing with our knowledge share series. This on-site experience will give participants a chance to view our facility and unique services in action. The primary goal of this seminar is for attendees to leave with a wealth of knowledge on how to execute their trials more effectively based on a solid understanding of having a harmonized physical and digital clinical supply chain.”

As industry leading experts, Almac hopes that the information presented during this complimentary lunch and learn seminar, and future seminars, can help to guide clinical supply professionals throughout their clinical supply journey.

To find out more and to sign up, please visit: https://www.almacgroup.com/lunch-and-learn-seminar-souderton-2018

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

Almac would like to acknowledge and thank all those organisations who have provided support over the last 50 years including Danske Bank, Invest NI, PWC and IDA.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com/50-years

The post Almac Group to host Clinical Trial Supply Lunch and Learn at North American Headquarters appeared first on Almac.

Almac Group Marks 50 Successful Years in Craigavon

admin — Thu, 06 Sep 2018 07:55:03 +0000

Organisation reaches 5,000 employees globally

Craigavon, N.I., 6 Sept 2018 – Almac is celebrating 50 years since its founder, Sir Allen McClay, opened the doors of his pharmaceutical development business on its Craigavon headquarters.

The organisation, which now operates in 18 locations across Europe, North America and Asia, was founded as Galen Limited in 1968. Following flotation on the New York, Dublin and London stock exchanges in 1997, Galen Holdings Plc became Northern Ireland’s first billion pound company.

When the company took a different path to that which Sir Allen had envisioned in 2001, he sold the majority of his shareholding and, in 2002, he founded the Almac Group.

Sixteen years later the campus at Craigavon serves as the organisation’s global headquarters and houses seven Business Units and this year saw the recruitment of Almac’s 5000th employee globally.

Alan Armstrong, CEO and Chairman of the Almac Group said: “When he opened the doors of his business 50 years ago in Northern Ireland, Sir Allen had a vision of making a substantial contribution to healthcare across the globe.

“We are proud of our global reputation for excellence built over those 50 years. Our client service, scientific and operational expertise right across the drug development lifecycle offers a tailored solution to each of our clients. It is the dedication of our exceptional employees that enables us to provide this service and we pay tribute to their work as we reflect on the success of our company.

“We are excited about the future of our company. We look forward to making more exciting announcements as we reach new milestones and advancements across the business. As we look forward to continuing success, we wish to thank all those who have played their part in our story so far. So to our employees, clients, suppliers and other key stakeholders, thank you.”

The company’s most recently published financial figures show a 19% rise in revenue to £531m. It also reported an increase in pre-tax profits, up from £27m in 2016 to over £33m for the year ending 30 September 2017.

ENDS

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

Almac would like to acknowledge and thank all those organisations who have provided support over the last 50 years including Danske Bank, Invest NI, PWC and IDA.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com/50-years

The post Almac Group Marks 50 Successful Years in Craigavon appeared first on Almac.

Almac Group Appoints New Site Head for Charnwood Campus, Loughborough, UK

admin — Mon, 27 Aug 2018 06:55:36 +0000

Craigavon, N.I., UK, 27 Aug 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced the appointment of a new Site Head for its Charnwood campus, in Loughborough, UK.

James Hurst, who joined Almac Pharma Services in 2008 as Analytical Manager, and in most recent years was Head of Pharmaceutical Development Operations at Almac’s global HQ site in Craigavon, has this year taken up the role of Site Head at the company’s new manufacturing and analytical facilities at the Charnwood Campus in Loughborough, UK.

Together with the Pharma Services’ Senior Management team, James will set the strategic direction of the site and will have responsibility for its operational management and performance.

James is a graduate of the Manchester Metropolitan University and holds a Bsc (Hons) in Chemistry.

John McQuaid, Vice-President Technical Operations of Almac Pharma Services commented “We are delighted that James has taken the position of Site Head at our Charnwood campus. James was key to the successful growth of our pharmaceutical development service offering at Craigavon and we look forward to him using this experience to drive the growth of operations at Charnwood as we increase capacity to support our global client base.”

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in Europe, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn.

The post Almac Group Appoints New Site Head for Charnwood Campus, Loughborough, UK appeared first on Almac.

Almac Group Appoints Jonothan Cooil as Vice President of Engineering, Facilities and Health, Safety & Environment

admin — Tue, 21 Aug 2018 06:55:14 +0000

Craigavon, N.I., UK, 21 Aug 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced the appointment of Jonothan Cooil to Vice President of Engineering, Facilities and Health, Safety & Environment. He will report to Almac Group CEO, Alan Armstrong.

Jon joins Almac with more than 20 years’ experience with some of the world’s leading companies. Most recently he was employed as Head of Engineering and HSE at a major global pharmaceutical company and was directly responsible for leading the expansion and regrowth of one of its sites. In addition, he led the corporate adoption of process safety in manufacture for the global organisation.

Previously, Jon was employed as Chief Engineer and Head of Process Safety at Warwick International, the world leader in the manufacture of Tetraacetylethylenediamine (TAED), where he was responsible for engineering and process safety on a 30 acre top tier Control of Major Accident Hazards (COMAH) chemical site.

Jon is a highly respected academic and has lectured at John Moores’ University as well as being the external examiner in the BEng and MEng engineering courses. He is also a certified 6 sigma black belt and a Total Productive Maintenance (TPM) champion.

Alan commented, “We are delighted to have Jon join the Almac leadership team. He has a proven track record of driving improvement and operational efficiency which is aligned to our global growth plans. His wealth of experience will be invaluable to our future success.”

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Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations throughout Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Almac Group Soars up Ulster Business Top 100 Charts

admin — Wed, 15 Aug 2018 07:55:52 +0000

Craigavon, N.I., 15 Aug 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is honoured to be included in the top ten list of this year’s Ulster Business top 100 companies.

The news comes as the company’s figures for year ending 30 September 2017 reported a 19% rise in revenue to £531M and an increase in pre-tax profits, up from £27M in 2016 to over £33M.

In a supplementary table listing the most valuable firms in Northern Ireland, Almac, with a net worth of £276.9M, was recorded as only one of two privately owned companies within the top six. Whilst the global organisation was listed in the top 3 companies with the most employees which has increased by over 10% to 4,407.

Alan Armstrong, CEO Almac Group commented: “I am delighted with our ranking in this year’s Ulster Business top 100 companies list. 2017 was a particularly strong year for Almac with significant investment made for the long term benefit of the Group, including global expansion into key strategic territories. Achieving such a high position in all 3 tables is testament to the quality, expertise and innovative services provided by our dedicated employees globally and I look forward to many more years of success.”

The Ulster Business Top 100 listing is compiled by independent consultant Jonathan Cushley and incorporates the results of Northern Ireland based companies, either Northern Ireland registered or when a significant portion of their business is driven and transacted through the province.

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with operations in Europe, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac Group Soars up Ulster Business Top 100 Charts appeared first on Almac.

Almac Group Launches GMP High Throughput Peptide Manufacturing Service

admin — Fri, 27 Jul 2018 07:55:04 +0000

Craigavon, N.I., 27 Jul 2018 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce the successful MHRA registration of its High Throughput GMP Peptide manufacturing facility. Based at the Technopole campus near Edinburgh, Scotland, the facility manufactures neoantigen derived peptides for use in the production of patient specific, individualised cancer vaccines.

Speed is critical within this therapeutic context as the entire supply chain is focused on minimising “needle to needle” time – i.e. the time between the initial patient biopsy and the ultimate vaccine administration. Almac Sciences’ experts have been associated with the individualised cancer vaccine field for several years and its facility and systems have been set up to enable fully GMP compliant manufacture and release of 20-30 GMP peptides within less than three weeks.

Almac has manufactured multiple High Throughput batches of neoantigen derived peptides –branded by Almac as NeoPeptides™ – for compassionate use treatments, and for P-I clinical trials, from its Edinburgh facility. Over the course of the past ten months the facility has been upgraded and segregated to enable GMP supply. A bespoke Pharmaceutical Quality System has been designed and implemented to enable high speed, fully compliant GMP manufacture. The systems have now been tested through a number of Pivotal Engineering Runs and have demonstrated robust performance and the ability to consistently achieve the less than three weeks peptide manufacturing target. GMP supply is expected to commence in Quarter 3, 2018.

Dr Charles Shields, Vice President Peptides and Small Molecule API, Almac Sciences commented “Almac is very excited to be at the leading edge of this revolutionary approach to immuno-oncology. The systems and capabilities we have established are world leading, but our vision goes beyond today’s performance and we already have clear plans for how to deliver higher capacity and faster manufacturing rates.”

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IVRS technology (IXRS®) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn

The post Almac Group Launches GMP High Throughput Peptide Manufacturing Service appeared first on Almac.

Almac Clinical Technologies Releases New Podcast Series Entitled “Spotlight on IRT: Best Practices”

admin — Wed, 25 Jul 2018 11:55:45 +0000

Souderton, PA – 25 July 2018 – Almac Clinical Technologies, a global leader in technology-enabled solutions for managing clinical trial patient and supplies data through its flagship IXRS® 3 Interactive Response Technology (IRT) debuts a first-in-industry podcast series entitled, “Spotlight on IRT: Best Practices.”

This podcast features both Almac thought leaders and outside experts discussing best practices relating to IRT, protocol changes, regulatory audits and the most current innovations in order to improve costs, safety and efficiencies in today’s complex clinical trials. The podcast homepage resides on the resource-filled Almac Clinical University and offers the listener the opportunity to submit questions, comments and/or a speaker for future episodes.

“Almac Clinical Technologies has been the leading partner in providing solutions and solving the challenges that occur in today’s dynamic global clinical trial landscape. Too often we see clients relying on legacy processes out of familiarity and forget to consider alternatives that may prove to be more efficient ways to approach a problem. Our intent is to shed light on some of the problem areas we see our clients facing on a regular basis, and suggest proactive and holistic solutions which can be readily implemented to ensure continued success,” said Valarie Higgins, President and Managing Director of Almac Clinical Technologies.

Matt Lowrie, Almac Clinical Technologies’ Quality Assurance Group Manager, who has 15+ years of hosting and managing regulatory agency inspections and effectively answering demands for hundreds of trials, serves as host for the series. The “Spotlight on IRT: Best Practices” podcast is free to access, available on iTunes®, Google Play™ and all other available podcast applications. Amazon Echo owners can also enable access to the podcast through the Almac Podcast skill, then simply asking Alexa to “Play Almac Podcast.”

To learn more about how Almac Clinical Technologies can help to transform your clinical trial, please visit almacgroup.com/clinical-technologies

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, Interactive Response Technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo)

To keep up to date with our latest news, follow us on Twitter and LinkedIn.

almacgroup.com

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Almac Group Appoints Three Vice Presidents

admin — Wed, 25 Jul 2018 07:00:28 +0000

Craigavon, N.I., 25 July 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced the appointment of three new Vice Presidents within its Pharma Services Business Unit as it expands its executive team.

Jonas Mortensen is appointed to the position of Vice President of Business Development. Bringing extensive experience to the role, Jonas is responsible for leading the global Business Development, Proposal and Marketing teams. Jonas is a graduate of the University of Copenhagen with a Masters in Biology. He started his career in discovery research as a scientist and project management before progressing into quality management for a Scandinavian pharmaceutical products company and until recently, worked in Business Development for a leading CDMO.

Grainne Hughes, who joined Almac Pharma Services in 1999 and in most recent years held the position of Head of Operations, was promoted to Vice President of Business Support Operations. Grainne will lead all support functions across the business including Client Services, Planning, Business Systems and Business Projects. Grainne graduated from Queen’s University Belfast with a BSc in Biomedical Sciences and also obtained an MSc in Manufacturing Management from Ulster University.

In a similar move, Mark English, who joined Almac Pharma Services in 2010 as Distribution Manager and in most recent years was Head of Logistics, has now been promoted to the position of Vice President of Packaging & Logistics Operations. In this role, Mark will have responsibility for all packaging and logistic operations across Almac Pharma Services’ global commercial facilities in the UK, Ireland and USA. Mark is a graduate of the University of Edinburgh and holds a BEng in Chemical Engineering.

Graeme McBurney, President and Managing Director of Almac Pharma Services commented “We are delighted to welcome Jonas, Grainne and Mark to their new positions at Almac Pharma Services. They each bring a wealth of experience and impressive track records in their various roles. We look forward to their contribution to the delivery and success of our future expansion plans.”

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About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo). To keep up to date with our latest news, follow us on Twitter and LinkedIn.

The post Almac Group Appoints Three Vice Presidents appeared first on Almac.

Almac Group Invests in NMR Equipment to Enhance Existing Analytical Services Capability

allie — Mon, 16 Jul 2018 07:45:44 +0000

Craigavon, N.I., 16 July 2018 – Almac Group, the global contract development and manufacturing organisation, has announced a £375,000 investment in additional NMR instrumentation at its global Headquarters, Craigavon, UK.

As part of Almac Sciences’ state-of-the-art cGMP facility, enhanced NMR services will be offered to help deliver comprehensive solutions supporting drug substance (API) and drug product development programs from early phase to commercialisation. These services include advanced characterisation and purity assessment abilities in line with regulatory requirements. This investment boosts the existing well-established Almac NMR testing service already available to clients.

The new 500MHz NMR instrument setup at Almac incorporates Bruker’s cutting-edge Avance Neo platform, in addition to a Prodigy Cryoprobe all within a temperature controlled environment. This provides greater flexibility, higher sensitivity and resolution. The capability to analyse nuclei from 15N to 31P, in addition to a wide range of 2D and quantitative NMR experiments, now allows Almac to increase its NMR service offering.

Almac’s dedicated NMR team has worked with many pharmaceutical companies providing novel solutions to their scientific problems, and now, with analysis running up to ten times faster, the increased through-put and capacity will increase efficiency and turnaround times. In addition, the latest software includes additional processing capabilities and provides superior data integrity controls which will ensure increasing regulatory compliance needs are met.

Dr John Malone, Analytical Manager, Almac Sciences welcomed this enhanced investment “The latest NMR technology installation in our cGMP lab allows increased flexibility and capacity enabling us to better serve our clients.”

“Almac’s continual investment to increase service capacity and ensure full regulatory compliance enables our clients to progress their projects more efficiently through the drug development cycle.” added Dr John Robson, VP Quality Operations, Almac Sciences.

#ENDS#

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“Portadown Gets Active” A summer scheme to support local children and end holiday hunger

admin — Fri, 06 Jul 2018 07:55:04 +0000

Children in Northern Ireland has just launched its latest “Gets Active” scheme to support local children in Portadown. The programme is being delivered in partnership with the community and voluntary sector, statutory agencies, local schools, local government and business.

The “Portadown Gets Active” summer programme is about fun, learning and food. It encourages young people to stay active during the summer months, attain a qualification and enjoy a healthy snack and lunch.

The programme is being held in St John the Baptist College to make the most of the school estate which would otherwise lie empty during the summer holidays.

The project was created in response to evidence that many families face severe difficulties during holiday periods when free school meal entitlement ends. Our project not only provides a healthy snack and lunch, but also gives children the opportunity to take part in a range of activities and gain an OCN qualification. Over 70 children are taking part in the programme. With a further 20 older children having already taken part in an OCN in Youth Work.

Pauline Leeson, Chief Executive of Children in Northern Ireland said:
“The premise behind free school meals is that children from low income families have access to a hot nutritional lunch during school. At times they also receive breakfast too. But what happens to those children during the long summer holidays and other holiday periods? For some families, the school holidays can be a struggle. It’s not just the increase in food cost but the pressures associated with keeping children active.”

The project in Portadown is a partnership between Oasis Youth Portadown, Children in Northern Ireland, the Children & Young People’s Strategic Partnership, Family Support Hubs, ABC Council with additional support from the Public Health Agency, food supplier Brakes UK and the Almac Group.

Alan Armstrong, Chairman & CEO Almac Group said: “We are aware that many local families face challenges in providing healthy meals for their children over the summer holidays. At Almac, we are proud to support such a positive and fun programme which focuses on educating young people about staying active and eating healthily, as well as gaining a qualification. This scheme is of great value to our young people and wider society both now and for the future, equipping them with the skills they need to become healthy adults and we are delighted to be associated with it.”

ENDS

Notes for editors

CiNI represents the interests of its 160-member organisations providing policy, information, training, and participation support services to members in their direct work with and for children and young people. CiNI membership also includes colleagues in the children’s statutory sector recognising that the best outcomes for children and young people are increasingly achieved working in partnership with all those who are committed to improving the lives of children and young people in NI.

The Children & Young People’s Strategic Partnership (CYPSP) is a multi- agency partnership that includes the leadership of key statutory agencies and community and voluntary organisations that have a responsibility for improving the lives of children and young people in Northern Ireland. Chief Executives represent statutory agencies on the partnership and an open call ensured senior representation of organisations from the community sector and voluntary sector.

Oasis is a local community group based in Portadown who work directly with over 700 children, young people and their families on a cross community basis, including a wide range of those from minority ethnic backgrounds.

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs close to 5600 highly skilled personnel.

Almac is headquartered in Craigavon with operations throughout Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

The post “Portadown Gets Active” A summer scheme to support local children and end holiday hunger appeared first on Almac.

Brexit – a seamless solution

evewallace — Tue, 05 Jun 2018 09:21:50 +0000

Timely assurance to you, our client, in relation to Brexit negotiations

Download our “Brexit – a seamless solution” factsheet

Download factsheet

The post Brexit – a seamless solution appeared first on Almac.

Almac Group turnover surpasses £500 million for first time

admin — Mon, 04 Jun 2018 12:58:01 +0000

Pre-tax Profits recorded at over £33M

Craigavon, N.I., 4 Jun 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has reported a 19% rise in revenue to £531M.

The global company has also reported an increase in pre-tax profits, up from £27M in 2016 to over £33M.

Globally, employee figures increased by over 10% to 4,407. Of this total 2,920 staff are employed at Craigavon, representing an increase of also 10% or 270 staff on the previous year.

The figures were recorded in Almac’s annual report with its results for the year ending 30 September 2017.

2016 pre-tax profit was recorded at £27M. This year’s figure of £33M benefited from upfront and other payments relating to the out-licensing of oncology products which had been developed in house by the group and which also contributed to the profit before tax figure for the year.

The company continued to invest in expansion projects in 2017 with the building of additional lab and office facilities and the ongoing construction of one of the largest pharmaceutical cold store facilities in Europe at its Global HQ campus in Craigavon.

Group CEO, Alan Armstrong commented: “2017 was a strong year for Almac with turnover over £531 Million and profits surpassing £33 million. During the year we made significant investment for the long term benefit of the Group including global expansion into key strategic territories. The financial benefit of these investments may not be realised immediately, however they will ensure steady and continued growth of the Group into the future. All our profits are reinvested into the business enabling us to offer best-in-class services and products to our clients and continue to be a leader in the life sciences sector.”

ENDS

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn

The post Almac Group turnover surpasses £500 million for first time appeared first on Almac.

Almac Group’s Vice President of Global Business Development Appointed to British American Business Council of Greater Philadelphia (BABCPHL) Board of Directors

admin — Tue, 29 May 2018 00:58:23 +0000

Souderton, US, May 23, 2018– Almac Group, the global contract pharmaceutical development and manufacturing organization, is proud to recognize the appointment of George Tiger, Vice President of Global Business Development, Almac Clinical Technologies, to the BABCPHL’s Board of Directors.

Leading global commercial activities for Almac Clinical Technologies, Tiger is responsible for the company’s commercial strategy and execution, working to build and strengthen client relationships, advance the industry-leading Almac ONE solution and expand strategic partnerships. He has over twenty-five years of success in sales, marketing and general management. Prior to joining Almac in 2015, Tiger served as Sr. Vice President for Health Market Science, and served in a number of global leadership positions with ERT and Abbott Laboratories. He is a graduate of Lafayette College with a BA in Economics and Business.

Michael Pedrick, BABCPHL President, commented: “The BABCPHL is pleased to welcome Almac as a Club Level Member. As a global pharmaceutical and biotech company, Almac represents a highly significant and growing business sector for the Greater Philadelphia region, and one that is a key component of US/UK trade in our area. We are delighted George is joining our Board of Directors. He will offer depth and insight about this critical sector, and will help our organization advance our mission and that of Almac through affiliation with the BABCPHL.”

Last year, the Almac Group hosted Ross Allen, Deputy Consul General and US Director of the Department for International Trade, and John Hoggard, Vice Consul and US Healthcare Sector Lead, to present a comprehensive overview of Almac’s history, global presence, and local operations.

Valarie Higgins, President & Managing Director of Almac Clinical Technologies, was also a recent finalist for the BABC’s global Transatlantic Growth (TAG) Women in Business Silver Award, which celebrates successful companies growing their transatlantic business, for her work to implement a successful growth strategy between Europe, the US, and internationally.

To learn more about Almac Group’s work in the US and globally, please visit: https://www.almacgroup.com or e-mail media@almacgroup.com.

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group’s Vice President of Global Business Development Appointed to British American Business Council of Greater Philadelphia (BABCPHL) Board of Directors appeared first on Almac.

Almac Group Participates in National Take Our Daughters and Sons to Work Day

admin — Fri, 04 May 2018 12:52:50 +0000

Souderton, U.S., May 4, 2018– Almac Group, the global contract pharmaceutical development and manufacturing organization with North American headquarters in Souderton, PA, participated in the nationally organized Take Our Daughters and Sons to Work Day, coordinating a full event schedule for over one-hundred and fifty children of Almac employees.

Organized into groups according to age, the projects covered the company’s unique service areas, including science demonstrations, clinical packaging relays, tours of supply chain warehouses, and individualized career development. Participants at Almac’s Durham, North Carolina facility had the opportunity to dissect a strawberry’s DNA, guided by diagnostic subject-matter-experts. Each group also contributed to organizing care packages to help our military heroes, aiding the Military Working Dog Team Support Association.

Helene Matthews, US Training Director, commented: “Almac enjoyed hosting this event for our employees’ families, as it fosters a shared educational experience and further provides participants with insights to an exciting and continually evolving industry. We thank everyone for their contributions and helping to make this year’s ‘Agents of Positive Change’ theme a success.”

A national movement led by the Take Our Daughters And Sons To Work Foundation, this year’s event focused on creating a transparent and equitable experience to showcase opportunities that girls and boys can use in their continued career exploration and build upon with future educational achievement.

Arden Pengelly, Parent and HSE Supervisor, commented: “STEM education is important to my children’s future. I’m proud to work for a company like Almac who chooses to invest resources and places considerable value on events like these. Many companies try to live up to their core values; Almac is a company that always does.”

To learn more about Almac’s dedication to its employees and corporate social responsibility efforts, please visit: https://www.almacgroup.com or e-mail media@almacgroup.com.

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Participates in National Take Our Daughters and Sons to Work Day appeared first on Almac.

Almac Group Appoints David Taylor as Head of Manufacturing Operations

admin — Tue, 01 May 2018 07:55:07 +0000

Craigavon, N.I., 01 May 2018 – David Taylor joined the Almac Group in November 2017 as Head of Manufacturing, Almac Sciences. He is tasked with the overall accountability for small molecule API and peptide manufacturing in Craigavon, and delivering on Almac’ Sciences’ supply chain operations at the Northern Ireland site. David has worked in the pharmaceutical and fine chemical industries for over twenty-two years, and brings with him a strong background in both the technical and manufacturing disciplines, allowing him to lead multidisciplinary teams to deliver streamlined operational outcomes. In an industry with significant emphasis on safety, quality and regulatory compliance, David has the skill set needed to anticipate and successfully communicate planning and procurement changes to customers, clients and third-parties abroad.

Dr Charles Shields, VP Peptides & Small Molecule API commented “We are delighted to welcome David to Almac. He clearly brings an impressive track record which is especially important to us as we continue to drive global sales and operational excellence. With his expertise and level of experience he will prove to be a great asset to our senior management team.”

After graduating from Newcastle Polytechnic and completing his PhD and post doctoral studies at the University of Sunderland, David worked as a chemist transferring fine chemicals and API manufacturing processes from lab scale through to full commercial scale. He transferred from R&D into manufacturing, leading large teams of shift operators for the cGMP manufacture of a range of APIs and registered intermediates on a top tier CoMAH site at ChiRex (now Sterling Pharma).

Following that, David gained experience in manufacturing, project and program management and has led teams to deliver projects in pre-clinical process development and multi gram synthesis to early phase multi kilo manufacture and through to late phase full scale process validation, product stability (full ICH study) and regulatory filing submission (DMF, CEP). He has worked at sites around the UK for Piramal Healthcare, Aesica and the Wasdell group.

David latterly gained senior leadership experience in drug product manufacture at Wasdell manufacturing (formerly SCM Pharma) and was accountable on the MHRA and Home office licences.

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The post Almac Group Appoints David Taylor as Head of Manufacturing Operations appeared first on Almac.

Almac Group leads key workshops at the upcoming Global Clinical Supplies Group Conference (GCSG) in Atlanta, GA

admin — Fri, 27 Apr 2018 15:15:57 +0000

Souderton, PA, U.S., 27 April, 2018 – Almac Clinical Services, a member of the Almac Group, a global pharmaceutical contract development and manufacturing organisation, will lead multiple strategic workshops at the upcoming Global Clinical Supplies Group GCSG Conference held at Grand Hyatt Atlanta in Buckhead from April 29 – May 2.

The following sessions, led by senior leadership, are designed to deliver key insights and provide an opportunity for participants to learn more about the state of clinical trials:

Mark Rohlfing, Vice President of Operations and Natalie Balanovsky, JIT Manufacturing Solutions Manager, will present on conference day 2 at 10:05am and day 3 at 11:30am on, Just in Time Services, a Custom Solution for Clinical Supplies (WS1).
Paul O’Connor, Global Vice President of Quality, will participate in multiple workshops and a panel discussion referencing Brexit’s impact to clinical supply logistics, on conference day 1 at 10:15am and 2:55pm, day 2 at 1:40pm and day 3 at 11:30am.
Olive McCormick, Head of Quality & QP, will present on conference day 2 at 2:55pm, on the topic of Data Integrity in the Clinical Supply Chain.

Richard Segiel, Vice President of Business Development, applauded Almac’s involvement: “Adding exceptional value through education is imperative to Almac’s commitment to our clients. Our team looks forward to providing GCSG participants with new information and solutions for successfully navigating the challenges within the clinical supplies industry.”

Conference attendees will immerse themselves in networking with peers and key opinion leaders, have the opportunity to participate in Q&A sessions following presentations on a range of clinical supply subjects, and enjoy a relaxed and educational atmosphere. Inspired by the GCSG mission, the theme for this year’s event will be “Rooted in Knowledge and Branching out through Innovation.”

To meet with members of Almac’s leadership during the GCSG Annual Conference, sign-up here: https://www.almacgroup.com/events/global-clinical-supplies-group-annual-meeting-2018/

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group leads key workshops at the upcoming Global Clinical Supplies Group Conference (GCSG) in Atlanta, GA appeared first on Almac.

Almac Group Receives Recognition at The Irish Laboratory Awards with Laboratory Supplier of the Year Award

admin — Fri, 20 Apr 2018 07:55:51 +0000

Craigavon, N.I., 20 April 2018 – Almac Group, the global contract development and manufacturing organisation is delighted to announce it has won the Laboratory Supplier of the Year Award during this year’s Irish Laboratory Awards, presented by Business River. This award recognises BioClin Research Laboratories’, a Member of the Almac Group, commitment to delivering the highest quality analytical services to its customers and clients.

The Irish Laboratory Awards spotlight excellence and achievement in the laboratory environment, covering management, innovation, collaboration, personnel development and laboratory equipment supply. The winners were revealed at a ceremony on 19^th April at Ballsbridge Hotel in Dublin. An independent panel of recognised and expert judges, representing Ireland’s scientific sector, determined the 2018 winners.

Judges awarded this based on the excellence demonstrated as a service provider, delivering “best in class” solutions to the pharmaceutical industry. Five additional companies were finalists for each category, as part of over a hundred nominees competing for twenty-two individual category awards.

Stephen Barr, President & Managing Director, Almac Sciences, commented: “I’m proud of our employees who work daily to provide unparalleled service to our customers and clients throughout the world. This award serves to highlight our team’s dedication and commitment to quality, and also showcases our diverse ability to deliver pharmaceutical, bio science and laboratory supplier services to the industry.”

Launched in 2013, The Irish Laboratory Awards has established itself as the premier event in Ireland for benchmarking those that demonstrate excellence, best practice and innovation in Ireland’s laboratories. These awards are an opportunity to showcase a company’s extensive knowledge, enthusiasm and expertise in the industry.

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The post Almac Group Receives Recognition at The Irish Laboratory Awards with Laboratory Supplier of the Year Award appeared first on Almac.

Almac Group Continues to Share Expertise as part of North America “Lunch & Learn” Seminar Series

admin — Wed, 18 Apr 2018 15:01:36 +0000

Souderton, PA, U.S., 18 April 2018 – Almac Clinical Services, part of the global contract pharmaceutical development and manufacturing organisation the Almac Group, is delighted to share the completion of its second consecutive bespoke North America “lunch and learn” seminar, building on its global knowledge share series.

The complimentary seminar was held at the San Francisco Hilton Hotel on Tuesday, March 27. The presentations titled Understanding Clinical Packaging and Labelling Design Strategies and The Fundamentals of Clinical Supply Import/Export, helped to educate industry professionals on best practices related to clinical packaging and labelling, and clinical supply import/export – relevant subjects with the globalisation of clinical trials on the rise now more than ever.

A number of Almac’s subject matter experts, including Brian Hilton, Production Manager, and Tony Mistretta, Distribution Manager, travelled from Almac’s North American headquarters in Souderton, Pennsylvania and joined a large group of key thought leaders within the pharmaceutical and biotech industries.

The seminar provided the ideal platform for Almac’s experts to share their expertise and discuss real world experiences to provide advice about how integrating and optimizing clinical packaging, labelling, and distribution strategies can improve the overall success of a clinical trial, as well as reduce costs and timelines.

Tony Mistretta, Distribution Manager, Almac Clinical Services commented, “Part of Almac’s commitment to delivering the highest quality service to our clients is a foundation of partnership. One of our goals is to share the expertise we have built over three decades in the clinical supply industry by offering educational seminars like these. A particular thanks to all of the attendees, and we hoped you enjoyed the event as much as we did.”

As industry leading experts, Almac understands the challenges faced by its customers and hopes that the information presented during this complimentary lunch and learn seminar, and future seminars, can help to guide clinical supply professionals throughout their clinical supply journey.

The primary goal of these seminars is for attendees to leave with a wealth of knowledge related to the delivery of global clinical trials from beginning with protocol up through patient delivery. Future seminars will continue to aid customers in increasing their knowledge around global clinical trial supply services and to provide them with additional networking opportunities.

To find out more and to sign up to receive information about upcoming events, please visit: https://www.almacgroup.com/global-event-item/clinical-services/

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Continues to Share Expertise as part of North America “Lunch & Learn” Seminar Series appeared first on Almac.

Almac Group Expands US Specialised Commercial Packaging Capabilities

admin — Mon, 16 Apr 2018 13:00:57 +0000

Audubon, PA, 16 April 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is pleased to announce that it has expanded its US commercial packaging capabilities at its Audubon, PA facility.

Addressing increased client demand of developing and bringing more advanced medicines and niche orphan drugs to market, Almac Pharma Services has enhanced its offering by adding bespoke technology for the specialised packaging of complex kit assembly for medical devices, combination products and biologic packs.

The innovative semi-automated packaging system (SAPS) was tailor designed, built and installed by Almac’s in-house engineering team providing a best-in-class packaging solution for medical device kits and parenteral delivery forms.

The SAPS line provides a streamlined and efficient semi-automated process for the packaging of complex medical kit components and can process both standard and custom syringes, as well as auto-injector pens and any other medical devices. The highly customisable technology can operate to various scales, allowing for a variety of pack formats from sample kits to marketing packs in addition to multi-product dosage packaging.

Ensuring quality is guaranteed throughout the process, the specialised packaging line has multiple state of the art vision systems providing 100% automated verification and rejection of all components, ensuring variable data correctness, full colour recognition and medical kit completeness.

Graeme McBurney, President and Managing Director of Almac Pharma Services commented “Almac continues to invest in, and expand upon, our US commercial packaging capabilities. The introduction of this specialised technology not only enhances our existing US commercial labelling and packaging capabilities, but provides an efficient and cost effective semi-automated packaging solution to meet the evolving packaging needs of our client partners.”

To find out more visit the Almac booth #524 at this year’s CPhI North America in Philadelphia from 24th April.

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Expands US Specialised Commercial Packaging Capabilities appeared first on Almac.

Almac Diagnostic Services Validates Illumina TruSight® Tumor 170 Cancer Mutation Panel for Prospective Testing in Clinical Trials

admin — Mon, 16 Apr 2018 07:50:42 +0000

Almac Diagnostic Services Validates Illumina TruSight® Tumor 170 Cancer Mutation Panel for Prospective Testing in Clinical Trials

CLIA compliant assay, for clinical trial use, including US and Europe

Validation performance specifications for review on Almac Diagnostic Services’ website

Craigavon, N.I., Monday 16th April 2018 – Almac Diagnostic Services, a global stratified medicine company specialising in biomarker driven clinical trials, has analytically validated Illumina’s TruSight® Tumor 170 cancer mutation panel as an IUO assay for prospective testing in clinical trials.

Almac Diagnostic Services is now in a position to partner with interested Pharmaceutical and Biotech firms with the Almac clinical trial assay to support clinical trial enrichment for future cancer trials.

Almac Diagnostic Services was one of only a handful of labs globally to be granted beta test site status for the Illumina TruSight® Tumor 170 panel. This facilitated early access to the RUO version of the panel prior to Illumina’s initial commercial release back in 2016 and has allowed the labs at Almac to build up a vast amount of experience with the cancer panel over an extended period of time.

The Almac Illumina TruSight® Tumor 170 Clinical Trial Assay is a Next Generation Sequencing (NGS) assay for use with FFPE tissue from solid tumours that targets DNA and RNA variants from the same sample. The Almac assay covers common cancer genes including key actionable mutations across multiple cancers. It targets single nucleotide variants, indels and gene fusions. The clinical trial assay does not cover amplifications or splice variants, but these can be identified in the RUO version of the assay also offered by Almac Diagnostic Services.

Michael Sloan, Global VP of Commercial Development, Almac Diagnostic Services said: “This Almac Diagnostic Services clinical trial assay will provide Pharmaceutical and Biotech companies with a new option in the marketplace to support their clinical trials and CDx development. The assay, based on the Illumina TruSight Tumor 170 chemistry and NextSeq platform, allows multiple biomarkers to be evaluated from one sample, thereby reducing the quantity of precious tissue sample necessary and offering a highly cost effective solution that will ultimately be kit-able further downstream.

He continued: “It’s a strong tool in our repertoire of broad screening assays for our clients. This offering can enable them to assess both DNA and RNA on an appropriate broad range of genes. From the Pharma or Biotech perspective, they’re going to have a drug, or a panel of drugs, for which they want to select a relevant biomarker to enable personalised treatment. So it’s an optimal screening mechanism for them.”

Almac Diagnostic Services offers clients powerful reporting for the assay through their own bioinformatics pipeline and software solution providing enhanced variant call reproducibility, accuracy and QC. Should clients also need further RUO interpretation of detected variants, Almac can also offer ‘IBM Watson for Genomics’ reporting for processed samples.

For more information on the Almac TruSight® Tumor 170 clinical trial assay and to view the validation performance specification visit the Almac Diagnostic Services website:

https://www.almacgroup.com/diagnostics/trusighttumor170/

ENDS

About Almac Diagnostic Services

For more information visit: almacgroup.com/diagnostics

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Diagnostic Services Validates Illumina TruSight® Tumor 170 Cancer Mutation Panel for Prospective Testing in Clinical Trials appeared first on Almac.

“Portadown Gets Active” — A scheme to support local children and end holiday hunger

admin — Fri, 06 Apr 2018 07:55:42 +0000

Craigavon, N.I., 6 April 2018 – Children in Northern Ireland together with local community organisation Oasis Youth are running an Easter scheme to support local children in Portadown, providing nutritious meals and further education through a wide range of activities. The programme is being delivered in partnership with the community and voluntary sector, statutory agencies, local schools and local government.

This Easter more than 100,000 children are at risk of going hungry. What should be a time of enjoyment for many children and young people is, in fact, often a battle for families against food insecurity, social isolation and lack of exercise.

Local children learning how to bake fifteens at “Portadown Gets Active” Easter scheme.

The “Portadown Gets Active” programme was created in response to evidence that many families face severe difficulties during holiday periods when free school meal entitlement ends. This project not only provides a healthy snack and lunch, but also gives children the opportunity to take part in various indoor and outdoor activities focused on health, wellbeing and nutrition and, during the summer programme, gain an OCN qualification in Healthy Living.

Chief Executive of Children in Northern Ireland, Pauline Leeson, CBE, said: “The absence of free school meals is even more important during holiday periods as family budgets are already stretched.”

“School holidays are an expensive time for families where there is financial strain on increased food budgets, childcare costs and paying for activities to keep children and young people entertained. Many parents are faced with the difficult choice of how to feed their whole family, with many parents going without in order to feed their children.”

The project in Portadown is a partnership between Oasis Youth Portadown, Children & Young People’s Strategic Partnership, Pathways Activities with additional support from the Public Health Agency, food supplier Brakes UK and the Almac Group.

Kevin Reid, Almac Global VP of Marketing visited the Easter scheme and commented: ”Playing our part in the local community is a key priority for Almac and we are proud to support this fantastic initiative. It is vital to ensure our children and young people are given the opportunity to achieve and develop the skills they need to succeed in life and this scheme offers a range of activities which will stay with them as they transition into adulthood.”

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post “Portadown Gets Active” — A scheme to support local children and end holiday hunger appeared first on Almac.

Almac Group named by Deloitte as One of Ireland’s Best Managed Companies

admin — Mon, 26 Mar 2018 16:01:51 +0000

Craigavon, N.I., 26 March 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has been named as one of Ireland’s Best Managed companies in the Deloitte Best Managed Companies Awards programme.

Almac was awarded the status for the first time following a detailed qualification and judging process and was recognised for demonstrating superior business performance. 22 new companies join a requalifying network of more than 100 companies, built over a decade of the programme. The awards, in association with Bank of Ireland, culminated with the Best Managed Companies Awards symposium and gala in Dublin on 15 March 2018, which was attended by over 1,000 people from the business community.

As part of its ongoing expansion strategy, Almac recently announced the completion of a £20 million investment in its cold chain management capabilities with the opening of a 95,000 sq ft custom built cold store facility at its global headquarters in Northern Ireland. The organisation also recently confirmed further investment at its European Campus in Dundalk which is scheduled to be operationally ready by January 2019.

Commenting on the award, Kevin Stephens, Finance Director, Almac Group said: “We are pleased to be recognised as a Best Managed Company by Deloitte. This achievement highlights our commitment to the growth and development of Almac on a global scale, ultimately benefitting patients worldwide”.

Commenting, Deloitte Partner, Anya Cummins said: “2018 marks the 10th year of the Deloitte Best Managed Companies Awards programme, which has grown from 25 companies in year 1 to 137 in year 10. The programme represents companies from different industries with many industry-specific challenges but also common characteristics such as adaptability, innovation and ambition.”

The Deloitte Best Managed Companies programme promotes and recognises excellence in Irish/Northern Irish owned and managed companies. It is the only awards scheme in the region that considers a business’ performance from every perspective.

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

About Deloitte Best Managed Companies Awards

The Deloitte Best Managed Companies programme, in association with Bank of Ireland, promotes and recognises excellence in Irish/Northern Irish owned and managed companies. It is the only awards scheme on the island of Ireland that considers a business’ performance from every perspective.

Entrants to the programme will compete for this designation in a rigorous and independent process that evaluates the calibre of their management abilities and practices. Programme sponsors are Bank of Ireland, the Irish Management Institute and the Sunday Business Post. For further information, visit www.deloittebestmanaged.ie.

The post Almac Group named by Deloitte as One of Ireland’s Best Managed Companies appeared first on Almac.

Almac Group Recognised with CMO Leadership Awards

admin — Thu, 22 Mar 2018 15:10:28 +0000

Craigavon, N.I., 22 March 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced it has been awarded CMO Leadership Awards for the sixth consecutive year.

The CMO Leadership Awards recognises top outsourcing partners, determined by feedback from sponsor companies who outsource manufacturing. Each year, the awards are presented by Life Science Leader and Industry Standard Research (ISR) during an annual award ceremony which celebrates drug development and manufacturing.

Almac Pharma Services received three awards at the prestigious celebratory event held on 21 March in New York which recognised its capabilities, overall compatibility and outstanding quality at small pharma level.

The global organisation recently announced the completion of a £20 million investment in its cold chain management capabilities with the opening of a 95,000sq ft custom built cold store facility at its global headquarters in Northern Ireland. The new facility complements Almac’s existing global drug product capabilities by boasting over 3,000 pallet spaces including -15°C to -25°C storage capacity, additional 2°C – 8°C secondary production rooms, 3PL processing areas and a custom designed clinical labelling suite.

Adam Schroeder, Director Business Development, Almac Pharma Services commented “Once again, we are delighted to receive these awards which recognises continued investment in our global capabilities and solutions. This achievement strengthens our commitment to better serve our clients, and ultimately patients worldwide, thereby maintaining our position as a global leader in the life sciences sector.”

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Recognised with CMO Leadership Awards appeared first on Almac.

Almac Group Launches ‘Almac McKervey Award’ for Excellence in Organic Chemistry

admin — Thu, 22 Mar 2018 10:30:52 +0000

Commemorating the life and work of Professor Tony McKervey

Craigavon, N.I., 22 March 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is delighted to announce the launch of the ‘Almac McKervey Award for Excellence in Organic Chemistry’, a commemoration to the life and work of one of Ireland’s most distinguished scientists, Professor Tony McKervey.

Open to students studying Chemistry or Medicinal Chemistry at the School of Chemistry and Chemical Engineering, Queen’s University Belfast, the ‘Almac McKervey Award’ will be presented to a student selected on the basis of academic achievement and performance at an interview with Almac’s chemistry experts.

The winning student will also receive a £1,500 bursary towards tuition fees, in addition to a paid twelve month placement with Almac to gain industry experience and mentorship. The inaugural ‘Almac McKervey Award ‘ceremony will be held at Queen’s University Belfast in October 2018.

Stephen Barr, Managing Director, Almac Sciences commented: “We chose to name an award after our esteemed colleague and friend, Tony, as a fitting tribute to someone whose leadership, exemplary work ethic and kind demeanour have inspired many of us during his many years of service with Almac. His academic and industrial career has made a considerable impact on many who studied and worked for, and with him, across the world. Tony was committed to supporting students with a shared passion for science and this award is designed to support outstanding achievement in organic chemistry and to further cement Tony’s research legacy within the field.”

Professor Peter Robertson, Head of School, School of Chemistry and Chemical Engineering commented: “Queen’s University Belfast is delighted that Almac has launched the ‘Almac McKervey Award for Excellence in Organic Chemistry’. Professor McKervey was a valued colleague and made a huge contribution to organic chemistry, both as an academic at Queen’s University Belfast and University College Cork and through his key involvement with industry, particularly with Almac. This award is a fitting legacy for Professor McKervey’s significant contribution as a world leading Organic Chemist.”

Last October, Almac partnered with the Hans Sloane Trust to launch the inaugural ‘Sloane McClay Award’. This award recognises and rewards the top student who obtains the highest combined marks in biology, chemistry, physics and maths at GCSE level. Many leaders in Northern Ireland, including both Sir Hans Sloane and Almac Group Founder Sir Allen McClay, envisioned a world dedicated to advancing human health. Almac continues to deliver on their achievements and dedication through helping to further develop youth engagement and support of Science, Technology, Engineering, and Maths (STEM) education.

For further information on the Almac McKervey Award, please contact Frances Weldon (STEM Outreach Manager) Almac Group.

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Launches ‘Almac McKervey Award’ for Excellence in Organic Chemistry appeared first on Almac.

Almac Group Partners with Indian Valley Chamber of Commerce

admin — Tue, 20 Mar 2018 11:00:29 +0000

A Discussion on the Importance of Shaping Company Culture in the Workplace

Souderton, U.S., March 19, 2018– Almac Group, the global contract pharmaceutical development and manufacturing organization with North American headquarters in Souderton, PA, partnered with the Indian Valley Chamber of Commerce (IVCC) to host a conversation with local business and civic leaders on how to successfully shape and support a company’s culture, allowing it to be a truly exceptional place to work.

Moderated by Sally Derstine, Managing Partner, Delaware Valley Family Business Center, the event was held on Wednesday, March 14^th bringing together over fifty community members in conversation highlighting many of the key categories for long-term employee success, including training and development, staff recognition, health & wellness, and long-term vision. A balanced work culture brings together employees at all levels, supporting a cohesive environment for mutual success and combined growth.

Steven Hunsberger, Executive Director, Indian Valley Chamber of Commerce, commented: “Creating and maintaining the appropriate culture is integral to the long-term success of an organization and the people of which it is comprised. The Chamber is pleased to have good corporate citizens, like the Almac Group, to partner with and make programming available to help chart the success of all the businesses in the community.”

Rich Moore, US Director of Human Resources, Almac Group, commented: “People are our core asset. Individually and collectively, they are critical to the success of our vision, and we are proud to join with organizations like the (IVCC) in helping to cultivate this focus among businesses in our community.”

To learn more about our many US careers or further read about why the Almac Group is driven by a unique entrepreneurial culture and commitment to grow and succeed please visit: https://www.almacgroup.com or e-mail media@almacgroup.com.

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

About the Indian Valley Chamber of Commerce

For over 30 years, we have served the Indian Valley Communities (Souderton, Telford, Franconia, Lower Salford, Upper Salford, Hatfield, Skippack, Towamencin, Rockhill, Hilltown and Salford). Our 450 members are made up of businesses and individuals dedicated to promoting a favorable economic climate and enhancing the quality of life in the Indian Valley Area. We’re ‘Business Advocates’ supporting ‘Community Development’ with a spirit of co-operation!

The post Almac Group Partners with Indian Valley Chamber of Commerce appeared first on Almac.

Almac Group Presents “Sir Allen McClay Award for Excellence in Chemistry”

admin — Mon, 12 Mar 2018 13:00:13 +0000

Awarded at the 61^st Annual Montgomery County Science Research Competition

Souderton, U.S., March 12, 2018— Almac Group, the global contract pharmaceutical development and manufacturing organization, is proud to announce its recent sponsorship of the Montgomery County Science and Teachers Association (MCSTA), and furthermore, delighted to recognize three middle school and three high school Montgomery County students for their innovative research and exemplary projects in the field of chemistry.

Student recipients at the high school level included 1) Angie Kuang, Methacton High School, 2) Annabelle Laughlin, Upper Dublin High School, and 3) Sophia Breslim, Dock Mennonite Academy High School. Student recipients at the middle school level included 1) Dylan Kuang, Arcola Intermediate School (Methacton), 2) Andrew Zhang, Arcola Intermediate School (Methacton), and 3) Anna Smith, Dock Mennonite Academy Middle School.

Michael Cannarsa, Director of Business Development, Almac Sciences, commented: “Advancing human health is our mission at Almac, and broadening education opportunities for local students is important for building on that mission going forward. We congratulate all on their successful participation and encourage them to continue asking questions and seeking answers in their pursuit of higher learning.”

The competition works to emphasize a commitment to STEM research and provides a platform for students to contribute related projects in over fourteen categories within their chosen field. The culmination of teacher, parent, and community organizations enables students to express their future interest in these career paths, as they illustrate creativity and enthusiasm.

Held at the Floy Lewis Field House at Ursinus College in Collegeville, PA, over four hundred participants submitted projects. The first, second, and third place winners from each category will move on to The Delaware Valley Science Fair, positioning students to make significant contributions to research and discovery.

Philip Rittenhouse, Event Director, commented: “We are pleased to have the Almac Group partner with us in helping to advance Science, Technology, Engineering, and Math (STEM) offerings in the region. With having three PA-based facilities across Souderton, Lansdale, and Audubon, we’re thankful for your support in furthering community education initiatives that have a direct impact on your employees and their families.”

To learn more about Almac Group’s work in the US and globally, please visit: almacgroup.com

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Presents “Sir Allen McClay Award for Excellence in Chemistry” appeared first on Almac.

US East coast storm: update

admin — Thu, 08 Mar 2018 08:58:16 +0000

Following a Health and Safety assessment of our Pennsylvania sites at Souderton, Lansdale, and Audubon and review of the prevailing weather conditions, we are pleased to announce that our operations have re-opened today.

Impact on clinical shipments

Almac is committed to continuity of supply and customer service excellence and will endeavour to mitigate any significant impact due to this short closure.
If you have any concerns or critical shipments that need to be prioritized please contact your Project Leader or our monitored helpdesk at logisticsservices@almacgroup.com.

The post US East coast storm: update appeared first on Almac.

Storm Emma – Update

admin — Fri, 02 Mar 2018 15:29:01 +0000

Following a Health and Safety assessment of the Almac Group site and review of the prevailing weather conditions, we are pleased to announce that our Northern Ireland operations will re-open on Friday 2^nd March from 3.30pm.

Impact on clinical shipments

We have been closely monitoring the situation with our Courier partners to minimise any impact upon shipments. Arrangements for additional staff and courier collections over the weekend and into next week have been made to further reduce any impact upon supply.

If you have any concerns or critical shipments that need to be prioritised please contact your Project Leader or our monitored helpdesk at logisticsservices@almacgroup.com.

Almac is committed to continuity of supply for our clients and customer service excellence and will endeavour to mitigate any significant impact due to our short closure.

The post Storm Emma – Update appeared first on Almac.

Almac Group Expands with Opening of £20 million Cold Chain Facility

admin — Wed, 28 Feb 2018 08:00:19 +0000

Continued investment in global expansion and service portfolio

Craigavon, N.I., 28 February 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, today announced the completion of a £20 million investment in its cold chain management capabilities with the opening of a 95,000sq ft custom built cold store facility at its global headquarters in Northern Ireland.

With over 30 years’ experience in the field of global distribution and management of temperature sensitive drug products, this expansion strengthens Almac’s ability to provide a seamless, best-in-class service to its growing global client base by ensuring efficient and effective delivery of both clinical supplies and commercial drug products.

The cold store, which is one of the largest of its kind in Europe, has been purpose built in response to customer requirements which includes consideration to the rapidly growing area of orphan drug products, changes to regulatory compliance and a more stringent focus on data across the supply chain. The additional capacity and tailored design also offers clients the opportunity to scale up with Almac as their biologic/biosimilar product portfolio increases.

The new facility complements Almac’s existing global clinical supply and drug product capabilities by boasting over 3,000 pallet spaces including -15°C to -25°C storage capacity, additional 2°C – 8°C secondary production rooms, 3PL processing areas and a custom designed clinical labelling suite. Supplementary office space has also been included to accommodate an additional 100 new employees who will be recruited as a result of the expansion.

Alan Armstrong, CEO Almac Group commented: “Once again, Almac has set the industry standard with another significant investment in our comprehensive global clinical and commercial supply chain offering. This new facility at our global headquarters expands our cold storage capacity by 300% and our frozen storage capabilities by over 50%, enabling us to better serve our clients, and ultimately patients, worldwide thereby maintaining our position as a global leader in the life sciences sector.”

This news comes just weeks after the company announced a £30 million investment in its new European campus based in Dundalk, Ireland which will ensure the company meets current and future client needs in the EU marketplace. This expansion includes a new QC laboratory, packaging facility for commercial drug products and a dedicated 79,000sq ft EU Distribution Centre for clinical trial supply, all of which is scheduled to be operationally ready by January 2019.

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Expands with Opening of £20 million Cold Chain Facility appeared first on Almac.

Almac Diagnostic Services Partners with DNAnexus to Power Clinical Trial Assay Development

admin — Mon, 12 Feb 2018 12:28:39 +0000

Craigavon, N.I., 12 February 2018 – Almac Diagnostic Services, a global precision medicine company, has selected Clinical Trial Solution (CTS), a product launched today by DNAnexus, the global leader in biomedical informatics and data management. Implementation of this product will enable Almac to streamline the use of next-generation sequencing (NGS) data in regulated clinical trials.

The DNAnexus cloud-based CTS enables the use of genomic and other -omic information in combination with trials data, to reduce the time and cost of clinical development, and improve trial results and patient care.

Almac Diagnostic Services has expertise in the development of biomarker assays for commercial partners across a wide range of technologies and has an extensive track-record in validating assays across key regulatory standards, including; CLIA, CLEP, CE-IVD and FDA.

“Genomic-based clinical trials are critical in identifying patient populations most likely to benefit from a targeted treatment,” said Dr Timothy Davison, VP of Data Sciences & Biostatistics, Almac Diagnostic Services. “The process of developing and validating a biomarker into a test fit for clinical delivery is complex. DNAnexus offers the industry’s most comprehensive security and privacy framework, which provides our global labs auditability, data immutability, and scalability to implement a streamlined integration of genome-based biomarker delivery in clinical trials.”

“The use of next-generation sequencing in clinical trials is on the rise, and we anticipate that the FDA will embrace these new clinical trial methodologies,” said Richard Daly, CEO of DNAnexus. “DNAnexus believes that the incorporation of genomic data into clinical trials will lead to more targeted therapies and improved companion diagnostics. Almac Diagnostic Services is a global leader in precision medicine and we’re excited to collaborate on bringing genomic-based targeted medicines to patients more quickly.”

Bringing a single oncology drug through FDA approval can take over a decade and cost more than $1 billion. By investing in NGS sequencing in early-stage clinical development, later phases can be optimized and de-risked through biomarker-driven participant selection and intervention guidance. The DNAnexus CTS combines secondary analysis, interpretation, and translational informatics solutions, on a GxP-compliant, quality managed, audit-friendly, cloud-based Platform-as-a-Service. The same compliant DNAnexus service powers the FDA’s precision FDA platform for advancing regulatory standards for NGS-based drugs and devices.

“Pharmaceutical companies and their research partners are looking for ways to incorporate human genome and microbiome-based insights into their clinical trial designs, and have been frustrated with the cost and time to deploy and operate GxP-compliant systems to manage high-throughput genomics data,” continued Richard Daly. “The DNAnexus Clinical Trial Solution enables our customers to rapidly integrate genomics into adaptive trial design and significantly improve outcomes, ensuring consistency and reproducibility of results across geographical regions and research partners.”

Deploying, qualifying, and validating bioinformatic tools for genomic data analysis, and operating GxP-compliant services, are specialized tasks that are required for discovery and use of genomics-based insights in clinical trials. The DNAnexus CTS enables biopharmaceutical companies to transition validated NGS pipelines from translational research into clinical development and, for approved drugs and devices, into clinical and companion diagnostics, all in compliance with HIPAA, CAP/CLIA, and GxP regulations.

For more information about Clinical Solutions and the DNAnexus Platform, please visit dnanexus.com/clinicaltrials

ENDS

About DNAnexus
DNAnexus, the global leader in biomedical informatics and data management, has created the global network for genomics and other biomedical data, operating in North America, Europe, Asia-Pacific (including China), South America, and Africa. The secure, scalable, and collaborative DNAnexus Platform helps thousands of researchers across a spectrum of industries – biopharmaceutical, bioagricultural, sequencing services, clinical diagnostics, government, and research consortia – accelerate their genomics programs globally. For more information on DNAnexus, please visit www.dnanexus.com or follow the company @DNAnexus.

About Almac Diagnostic Services
Almac Diagnostic Services is a global precision medicine company focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics. We partner with biopharma companies to provide solutions ranging from pre-clinical biomarker discovery to companion diagnostic development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited lab. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials. For more information visit: almacgroup.com/diagnostics

About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo). To keep up to date with our latest news, follow us on Twitter and LinkedIn

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Almac Group Appoints Dr Stefan Mix as Head of Biocatalysis

admin — Mon, 29 Jan 2018 09:00:55 +0000

Craigavon, N.I., 29 January 2018 – Almac Group, the global contract development and manufacturing organisation, has announced the appointment of Dr Stefan Mix to the position of Head of Biocatalysis, effective from 2 January 2018.

Stefan joined the Almac Sciences business in April 2005 as a chemist working in the lab on process development projects for chiral materials and has been part of the biocatalysis team since its beginnings. He has gained broad industrial experience including applications of biocatalysis, crystallisation development, process development for chiral building blocks and APIs, and technology transfer to manufacturing network partners, and was promoted to Biocatalysis Team Leader in 2012. All this time he has played a significant role in the development of Almac Sciences’ Biocatalysis Technology platform which has seen rapid growth and has multiple applications across a range of project scales and industry sectors.

In his new role, Stefan, who is the author of several publications will be responsible for the development and application of platform technologies within Almac Sciences leading a team of almost 50 scientists, in addition to supporting and directing commercialisation of new technology.

Stefan will report directly to Professor Tom Moody, VP Technology Development & Commercialisation, who congratulated him on his promotion: “Stefan’s wealth of knowledge, expertise and experience within biocatalysis and chemical synthesis has been critical to the success of our biocatalysis offering within Almac Sciences. I am delighted to announce Stefan’s promotion and wish him every success in his new role.”

Stefan was born in Berlin / East Germany, where he also completed his secondary education. After graduating with a Diploma in chemistry, he received his doctorate in 2004 from the Technical University of Berlin where he worked in a group under Professor Siegfried Blechert on stereoselective synthetic methodology and olefin metathesis.

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac Group Appoints Dr Stefan Mix as Head of Biocatalysis appeared first on Almac.

Almac Group Launches Bespoke Elemental Impurities Laboratory

admin — Wed, 24 Jan 2018 08:45:02 +0000

Craigavon, N.I., 24 January 2018 – The pharmaceutical industry is currently facing stringent new demands on elemental impurities from regulators stipulating the control and documentation of elemental impurities in drug products, drug substances and excipients. In response to these demands, Almac Group has announced significant investment in a state-of-the-art elemental impurities analysis laboratory at their European Headquarters, Craigavon, UK.

In compliance with USP <232 & 233>, EP (2.4.20) and ICH Q3D, all components, processes, packaging and final product must be risk assessed or tested for the presence of elemental impurities. Inductively coupled plasma mass spectrometry (ICP-MS) is widely recognised as the most suitable technique to meet the requirements of these, and future, regulatory requirements.

The new temperature controlled laboratory will incorporate industry-leading ICP-MS instruments; Thermo iCAP RQ C2 and Agilent 7900, in addition to MARS 5 and 6 microwave digesters. This investment enhances the existing well-established Almac ICP-MS testing service already available to clients.

Almac’s dedicated elemental impurities analysis team has already worked with many pharmaceutical companies to address the challenges of these new regulatory guidelines. A recent example was published in the Journal of Pharmaceutical and Biomedical Analysis: “Development and validation of an ICP-MS method for the determination of elemental impurities in TP-6076 active pharmaceutical ingredient (API) according to USP232/233” vol. 145, pp. 84–90, Oct. 2017.

“With this investment, we are in a position to fully support our global clients in both the pharmaceutical and biopharmaceutical sectors through the challenges of these new regulatory guidelines,” commented Dr Osama Chahrour, Leader of ICP-MS Services, Almac Sciences.

“Almac continues to invest heavily in state-of-the-art instruments and laboratories to meet the challenges of new regulations. This enables us to focus on fully supporting our clients through their drug development programs,” added Dr John Malone, Analytical Manager, Almac Sciences.

Almac Group

ENDS

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn

The post Almac Group Launches Bespoke Elemental Impurities Laboratory appeared first on Almac.

Almac Group Implements Salesforce Service Cloud to Enhance Client and Clinical Site User Experience

admin — Tue, 23 Jan 2018 12:00:32 +0000

Souderton, PA – 23 January 2018 – Almac Clinical Technologies, a global leader in technology-enabled solutions for managing clinical trial patient and supplies data through its flagship IXRS^® 3 Interactive Response Technology (IRT) has successfully implemented Salesforce Service Cloud, a best-in-class customer service software to facilitate inquiries from clients and clinical site users requesting live project support.

Run on the world’s number one Customer Relationship Management (CRM) platform, Almac Clinical Technologies implemented the system to deliver a smarter, streamlined approach to client support on a 24/7 basis. Unlike ticket-based systems currently being utilized throughout the industry, this Cloud-based scalable solution replaces auto-reply emails with real-time acknowledgement and empowers Almac Clinical Technologies’ IRT Technical Support Team to respond immediately to client or clinical site-user requests, ensuring real-time issue resolution. Using Service Cloud for all customer support activity produces enhanced predictive analytics that depict trending issues and service request-types. This enables Almac to anticipate future requests from clients and design preventative remediation tactics to ensure efficient and expeditious service.

“The fast-paced and time-sensitive nature of our industry requires service providers to be ready and able to respond to issues the moment they arise. By integrating Salesforce Service Cloud into our current processes, it allows us to see a full history of previous requests and feedback that mitigates future repetition and enhances reliability, therefore quickly resolving issues raised. We are proud to be the first provider in the market to deploy Salesforce Service Cloud to further enhance the experience of our clients and their clinical site partners,” commented Todd Kole, Vice President of Clinical Project Services.

By offering a more robust and reliable client service through Salesforce Service Cloud, Almac continues to keep their commitment to continuous improvement and delivering the most simple and effective customer experience for the clinical development community.

To learn more about how Almac Clinical Technologies can help to transform your clinical trial, please visit almacgroup.com/clinical-technologies

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About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, Interactive Response Technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs nearly 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo). almacgroup.com

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Almac Group announces further expansion at its European Campus in Dundalk

admin — Thu, 18 Jan 2018 08:00:54 +0000

Craigavon, N.I., 18 January 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, today confirmed the successful completion of Health Products Regulatory Authority (HPRA) inspections of Almac Clinical Services Ireland and Almac Pharma Services Ireland at its European campus in Dundalk, Ireland.

Almac previously confirmed that it secured new premises in Dundalk, Ireland in January 2017 as part of its ongoing global expansion strategy, to meet client demand and to address any potential challenges that may arise due to Brexit.

Following these successful HPRA inspections, Almac Group look forward to being officially licensed to conduct QP batch certification and release for both clinical trial material and commercial drug product from its European campus in Dundalk.

Ensuring the Group meets current and future client needs in the European Union marketplace, Almac has today announced further investment at the campus including a new QC laboratory and packaging facility for commercial drug products and a dedicated 79,000ft² EU Distribution Centre for clinical trial supply. This investment will more than treble the GMP footprint at its European campus which is scheduled to be operationally ready by January 2019.

This thirty million pounds investment complements the existing clinical supply and drug product development operations offered from its Global HQ site in Craigavon, NI – just 40 minutes by road from the new European campus.

The new European campus significantly increases the Group’s global footprint and provides an expanded presence within the European Union for both clinical trial supplies and commercial drug product operations, thereby providing uninterrupted service provision to its global clients.

Over the last 18 months, Almac has invested significantly, with the expansion of operational capabilities and employee numbers in each of its key territories including USA, Asia and UK. This announcement is part of a wider global expansion strategy. It will be paralleled with further investment and plans to increase employee headcount in all these locations in the coming 18 months, including its Global HQ in Craigavon, UK.

Alan Armstrong, CEO and Chairman of the Almac Group commented: “Achieving these successful HPRA inspections is a key milestone. In addition, the announcement today of further expansion will ensure our current and future clients receive a seamless solution with access to the EU marketplace. Crucially, this will ensure an uninterrupted service provision through any uncertainty Brexit may bring, and for the future, keeping Almac as a global leader in the life sciences sector.”

Welcoming the announcement Minister for Business, Enterprise and Innovation Heather Humphreys TD said, “This decision by Almac is a great vote of confidence in Dundalk, especially coming so soon after their initial decision to develop an operation in the area. It further strengthens Ireland’s Life Sciences capability in the North East and builds on a series of new IDA projects announced for Dundalk and elsewhere in County Louth over recent times. This exciting new facility is a further example of the success of our commitment under the Regional Action Plans for Jobs to provide quality jobs in regional locations.”

Commenting on the announcement Martin Shanahan, CEO, IDA Ireland said “This further investment in Almac’s European Campus in Dundalk is a very positive development for the company and the North East region. The Irish facility plays a strategically important role within Almac’s global footprint. Companies continue to choose Ireland as a location which provides certainty of access to the European Union in the long term post Brexit.”

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group announces further expansion at its European Campus in Dundalk appeared first on Almac.

Stunning Science Success Celebrated

admin — Fri, 05 Jan 2018 12:00:15 +0000

Craigavon, N.I., 04 Jan 2018 – Six top local science students, and their schools, have been recognised for their excellence through awards set up in memory of two of Northern Ireland’s most famous and forward thinking scientists, the Hans Sloane Medal and the Sloane McClay Award.

The Hans Sloane (Memorial Fund) Trust, in partnership with National Museums NI, was established in 1960 to commemorate the life and work of the celebrated Killyleagh physician, scientist and collector.

The Trustees award the Hans Sloane medal to the student obtaining the highest combined marks in biology, chemistry and physics each year at ‘A’ Level, along with their school, to recognise excellence in teaching.

This year, through a new partnership with Almac Group, a global pharmaceutical development organisation headquartered in Craigavon, the cash awards given to the top three ‘A’ level students have been increased and a new award for Northern Ireland’s brightest GCSE students has been established.

The winner of the Hans Sloane medal was Jamie Brannigan, a former pupil of St Colman’s College, Newry, who was also presented with a certificate and a cheque for £500. He is now studying Medicine at Cambridge University. St Colman’s principal, Cormac McKinney, also received a Hans Sloane medal from Professor Tim Harrison, Vice President, Drug Discovery, Almac Group.

Second place certificate and a cheque for £300 was presented to Zara Hamill from Omagh Academy and the third place certificate and a cheque for £150 was presented to Rachel Mooney from Regent House School, Newtownards.

The new award recognises excellence at GCSE level for science and maths students and has been introduced to commemorate the life and work of not only Sir Hans Sloane, but also Sir Allen McClay, the visionary entrepreneur and businessman from Cookstown, who founded the Almac Group.

The Sloane McClay awards were presented to Matthew Vennard, from Portadown College and principal Simon Harper by Professor Harrison. Matthew achieved the highest combined marks in biology, chemistry, physics and maths at GCSE level. Matthew, who is now is now studying for his ‘A’ levels, also received a cheque for £250.

Second place certificate, and a cheque for £150 was presented to James Pratt from Methodist College, Belfast. The third place certificate and a cheque for £50 was presented to Igor Silin, also from Methodist College.

Dr Sally Montgomery, a Hans Sloane Trustee, said: “The students have achieved remarkable marks across the subjects. The Trustees were delighted to introduce the new Sloane McClay award in partnership with Almac as it recognises the importance of maths and encourages students to consider STEM subjects for a future career in the field.”

Professor Tim Harrison, Almac, added: “Almac’s partnership with the Hans Sloane Trust enables us to recognise and reward excellence in key STEM subjects across the region. As a global business our success depends on the talent and skills of our most important asset, our people, and it is therefore crucial that we continue to invest in the next generation of scientists, mathematicians, engineers and tech experts. I would like to congratulate all the worthy recipients of the Hans Sloane Medals and the inaugural Sloane McClay Award and wish them every success for their careers.”

Kathryn Thomson, Chief Executive of National Museums NI, said: “We are delighted to partner with the Hans Sloane Memorial Fund and with Almac, recognising two of Northern Ireland’s most eminent scientists from the past. National Museums NI value learning and enriching the minds of all ages lies at the heart of what we do. These awards look to the future by rewarding our exceptional young science students and I would like to congratulate the six prize-winners on their outstanding achievements.”

To find out more about the Hans Sloane and Sloane McClay awards, visit almacgroup.com/sloanemcclay.

ENDS

About Sir Hans Sloane

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Stunning Science Success Celebrated appeared first on Almac.

Almac Group Launches Second Line for High Throughput GMP Peptide Manufacturing

admin — Tue, 02 Jan 2018 08:55:53 +0000

Craigavon, N.I., 2 January 2019 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce that they have brought online a second stream for High Throughput GMP Peptide manufacturing.

The High Throughput GMP Peptide facility, based in Edinburgh, Scotland, manufactures neoantigen derived peptides for use in the production of patient specific, individualised cancer vaccines.

Dr Charles Shields, Vice President Peptides and Small Molecule API commented “Almac’s decision to bring a second GMP NeoPeptides™ manufacturing stream online so quickly after the first is a clear statement of our commitment to the field of individualised cancer vaccines. We understand this market well and intend to maintain our world leading supply position on neoantigen derived peptides. We will be announcing further expansions of our facility and our service offering in the coming months.”

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About Almac Group

‘A unique culture delivering exceptional solutions’

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

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Young people presented with accredited awards at celebration event

admin — Fri, 08 Dec 2017 12:37:19 +0000

Amid media reports this week that 40% of young people in Northern Ireland are now obese or overweight, an awards ceremony in Portadown has shown how a key initiative encourages children to lead a healthy lifestyle.

Eighty young people from the Armagh City, Banbridge and Craigavon area who completed the Portadown Gets Active Youth programme over the summer months have been presented with Open College Network (OCN) accredited awards at a special celebration event.

The Portadown Gets Active programme, funded by the McClay Foundation and supported by Craigavon-headquartered Almac, was delivered through the Children and Young People’s Strategic Partnership’s (CYPSP) with partners Children in Northern Ireland, Pathway Activities NI, Oasis Youth Project, Education Authority, Public Health Agency and Brakes.

The youth summer programme encouraged young people to stay active during the summer months and helped them understand the importance of healthy living by providing them with the skills and confidence to cook simple nutritious meals on a budget. The OCN accreditation of the programme shows the possibilities of learning outside of a school setting and over the summer months in a fun and interactive way.

The Portadown Gets Active Programme emphasised the confidence, independence and team building skills that were built in the young people who participated on the programme.

In addition to creating a safe place for young people to continue learning and participate in physical activities during school holidays, the programme also fostered their relationship building skills and helped develop resilience to improve emotional wellbeing.

The awards evening was attended by statutory agencies including the Education Authority, Southern Health and Social Care Trust and the Health and Social Care Board.

Thirty eight young people received an OCN in Healthy Living and 58, aged between eight and 12 year were awarded with a mini medic’s first aid certificate of achievement. The awards event also showed the recognition of 20 peer mentors aged 12-16 year as who received an OCN in Peer Mentoring and collectively accrued over 720 volunteering hours of support on the programme over the summer months.

Hugh McCaughey, chair of the Children and Young People’s Strategic Partnership (CYPSP) commended the programme, saying: “CYPSP are committed to identifying what works through partnership working, co-design and co-production with organisations, children and their families. This work is being driven by a regional task and finish group for Northern Ireland.”

Andrew McCreery from Oasis Youth Project spoke on behalf of the partnership and said: ‘We are passionate about children and young people achieving their potential and recognise that being healthy is of prime importance in achieving this. Portadown Gets Active provided an excellent opportunity for our members to be educated about the importance of maintaining an active and nutritional lifestyle during the summer break”.

Alan Armstrong, CEO, Almac Group commented: “We were delighted to support this innovative programme and it is a privilege to attend the event to present OCN certificates to these inspirational young people. Congratulations to everyone involved in this outstanding project which has had a very positive impact within our local community.”

Ends

Notes to Editors:

The Children and Young People’s Strategic Partnership (CYPSP) is a multi-agency partnership, led by the Health and Social Care Board. It includes the leadership of key statutory agencies and community and voluntary organisations that have a responsibility for improving the lives of children and young people in Northern Ireland.

The post Young people presented with accredited awards at celebration event appeared first on Almac.

Almac Group Receives Annual Industrial Award from the Institute of Chemistry of Ireland

admin — Tue, 05 Dec 2017 08:30:36 +0000

Professor Tom Moody accepts accolade on behalf of Biocatalysis Team

Craigavon, N.I., 05 Dec 2017 – Almac Group, the global contract development and manufacturing organisation is delighted to announce Professor Tom Moody, VP Technology Development & Commercialisation at Almac & Arran Chemical Company, has received the prestigious Institute of Chemistry of Ireland Industrial Chemistry Award 2017.

Judges awarded Tom and his team with the honour based on the excellence demonstrated within Almac Sciences’ enzyme technology development research program. This is achieved through the unique collaboration between the biocatalysis team within Almac, headquartered in Northern Ireland, and Arran Chemical Company, Athlone, a member of the Almac Group since 2015.

The award was established to recognise the achievement of an individual chemist, or team of chemists, for making a significant contribution to the chemical or pharmaceutical industry in Ireland and the recipient is invited to present during the annual Eva Philbin Lecture – a series of keynote lectures in education institutions across Ireland. Eva Philbin was the first woman president of the Institute of Chemistry of Ireland. She began her career as a chemist in industry in 1939, and was chief chemist at two commercial companies before joining the chemistry department at University College Dublin in 1945.

Professor Moody presented his lecture on the subject of “Enzyme “feeds” rapid development and commercialisation” during the award ceremony held at the Albert Lecture Theatre, Royal College of Surgeons in Dublin, Ireland on 4^th December.

Tom leads a team of biocatalysis experts and is a distinguished chemist with an international reputation. He graduated from The Queen’s University Belfast with a 1st Class BSc(Hons) in chemistry before returning to gain a Ph.D. in Physical Organic chemistry. He has also completed a Masters Degree in Business graduating with distinction specialising in business strategy. His work has earned him numerous accolades and is co-author and author of >60 publications and patents. He is also an honorary Professor at Queen’s University of Belfast in the area of biocatalysis.

Upon receiving the award Professor Moody commented: “On behalf of the team at Almac Sciences and Arran Chemical Company, I am thrilled to receive this prestigious award. It is a true honour to be recognised in this way by the Institute of Chemistry and be invited to present a lecture in honour of Eva Philbin who is undoubtedly one of the most inspirational chemists of our lifetime. Special thanks to my entire team for their dedication, commitment and passion which has made winning this award possible.”

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Receives Annual Industrial Award from the Institute of Chemistry of Ireland appeared first on Almac.

Almac Clinical Technologies’ President & Managing Director Keynotes Life Sciences PA’s CRO & CMO Summit

admin — Mon, 13 Nov 2017 14:00:31 +0000

Souderton, U.S., November 13, 2017– Almac Group, the global contract pharmaceutical development and manufacturing organization, is delighted to recognize Valarie Higgins, President and Managing Director of Almac Clinical Technologies, as she keynotes Life Sciences PA’s upcoming CRO & CMO Summit.

Friday, November 17

West Pharmaceutical Services, Inc. in Exton, PA

8:00am – 11:00am

The CRO & CMO Summit is a half-day program designed specifically for those planning and conducting clinical trials or those who are seeking advice when selecting outsourced providers. Biotech, pharma, medical device, or diagnostic companies planning a clinical trial and individuals who have secured a CRO or CMO and the relationship was unsuccessful are encouraged to attend.

A distinguished and recognized leader in the Life Sciences and Healthcare IT sectors, Valarie Higgins is the Managing Director and President of Almac’s Clinical Technologies Business Unit, where she directs the overall strategic, financial, and operational leadership of the company. Since joining Almac nearly 18 years ago, Ms. Higgins has held numerous leadership roles, in which she was charged with direct responsibility for the overall commercial, operational, and client-centric success of the company.

Ms. Higgins’ remarks will provide an overview of the marketplace and how those within the industry can manage and cultivate long-term relationships to improve their clinical trial planning and maximize budgeting. Furthermore, she will discuss her career progression and ways she has developed and evolved as a leader.

The event is being held at West Pharmaceutical Services, Inc. in Exton, PA as part of their women’s leadership month that runs through the end of November.

To learn more about Almac Group’s work in the U.S. and globally, please visit: https://www.almacgroup.com or e-mail media@almacgroup.com.

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About Life Sciences Pennsylvania (LSPA)

Life Sciences Pennsylvania (LSPA), formerly Pennsylvania Bio, delivers two valuable services – public policy clout and strategic connections that can advance you and your organization. Our public policy work in both Harrisburg and Washington ensures that all of our members are heard by those who make legislative decisions.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Clinical Technologies’ President & Managing Director Keynotes Life Sciences PA’s CRO & CMO Summit appeared first on Almac.

Almac Group Enters Strategic Partnership with W5

admin — Mon, 06 Nov 2017 09:14:43 +0000

Million-pound agreement set to inspire next generation of scientists

Craigavon, N.I., 06 Nov 2017 – Over £1m is being invested through a partnership agreement between Almac Group and W5. The aim is to enhance STEM (Science, Technology, Engineering & Maths) knowledge and understanding among the next generation of budding scientists through interactive learning.

W5 has secured the Craigavon-headquartered global organisation as its Health and Life Sciences partner for the next 10 years, enabling W5 to expand its current footprint to create a dynamic new family learning opportunity.

The partnership includes a new 4,000sq ft exhibition area that explores the physical, chemical, genetic and medical aspects of the body. It will also showcase Almac’s history and its work carried out in the drug development cycle for pharmaceutical and biotech sectors globally. The new exhibition area is expected to open in autumn 2018.

Alan Armstrong, Chairman and CEO of Almac Group, said, “This is an exciting and forward-thinking partnership between Almac and W5, an award-winning science and discovery centre, which will provide key benefits for the people of Northern Ireland as well as both organisations.

“We are thrilled that the exhibition space adds to our existing presence in Belfast and provides us with a platform to tell our fascinating company history, from very humble beginnings to becoming a key player in the global biotech sector, employing almost 5,000 people worldwide, 3,000 of whom are based at our headquarters in Craigavon.”

“We plan to tell that story in an accessible and interactive way and hope we can inspire a new generation who have the potential to be employed in cutting-edge science in the future right here in Northern Ireland.”

Eric Porter, Chairman of the Odyssey Trust, said, “W5 and Almac share the aim of inspiring young people to consider careers in science, technology, engineering and maths. This agreement will also provide young people with the opportunity to explore an expanding array of careers within Almac and the biotech sector, as well as showcasing leading research and developments in biomedical science.”

“This new partnership with Almac supports our aim to create better life chances for young people by linking informal learning opportunities with leading industry partners to inspire and support STEM futures.”

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, Interactive Response Technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

almacgroup.com

About W5

W5 opened on the 30th March 2001 and has attracted over 3.5 million visitors. W5 has over 250 interactive exhibits spread over five levels. The building also contains Climbit – a multi-story climbing structure, Space-base – a multi-sensory activity zone, a lecture theatre, a temporary exhibition space and ancillary facilities including a shop and café. During 2016/17 W5 attracted 260,000 visitors, which included 30,000 pupils on formal education school visits.

W5online.co.uk

Inspiring Science Fund

The news of the agreement follows the recent announcement by the Odyssey Trust, the owners of W5, that £4.5m is to be spent on a major capital refurbishment and public engagement programme over the next three years. £3m was awarded through the Inspiring Science Fund, a collaborative initiative between Department for Business, Energy and Industrial Strategy (BEIS) and Wellcome with £1.5m being invested by the Odyssey Trust. The investment aims to establish a world-class innovative science centre that will create an inspiring visitor experience for new audiences and also increase visitor numbers.

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Almac Group’s US Financial Controller Appointed to Irish American Business Chamber & Network (IABCN)’s Board of Directors

admin — Thu, 02 Nov 2017 02:00:54 +0000

Souderton, U.S., November 02, 2017– Almac Group, the global contract pharmaceutical development and manufacturing organization, is delighted to recognize the appointment of Mark Weir, US Financial Controller, to the (IABCN)’s Board of Directors, based out of the City of Philadelphia.

Weir is a Fellow of the Institute of Chartered Accountants in Ireland and holds a Master’s degree from Dublin City University in IT & Accounting and a Bachelor’s Degree from Queens University, Belfast, N.I. in Economics. Originally from Northern Ireland, Mark moved to the USA in 2012 to accept his current position with the Almac Group. Prior to joining the Almac Group, Mark trained as a Chartered Accountant with PWC and worked in a number of international organizations, including a role leading the international expansion of a family-owned firm from Northern Ireland in establishing their first foreign facility in Kansas, U.S.

Kevin Kent, (IABCN) Chairman, commented: “The Irish American Business Chamber’s Board is thrilled to welcome Mark to our team. Mark adds a wealth of knowledge and experience. We know that his service, along with the continued involvement of Ambassador Club Member Almac Group, will only strengthen the Irish Chamber’s mission of serving our members, and promoting the development of economic and educational relationships between the United States and Ireland.”

The Almac Group became the first company headquartered in Northern Ireland to receive the prestigious Ambassador Award in 2016. The Ambassador Award is given annually to a member company that has helped to carry out the Chamber’s mission of strengthening business and educational ties between Ireland and the United States. Kevin Stephens, Finance Director of the Almac Group received the award from Barbara Jones, Irish Consul General on behalf of Anne Anderson, Irish Ambassador, at a ceremony in Philadelphia, U.S.

To learn more about Almac Group’s work in the U.S. and globally, please visit: https://www.almacgroup.com or e-mail media@almacgroup.com.

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About the Irish American Business Chamber & Network, Inc

The Irish American Business Chamber & Network is a nonpartisan business organization dedicated to promoting the interests of its members and the development of economic and educational relationships between the United States, Ireland and Northern Ireland. The Chamber provides growth opportunities to its members through a series of monthly networking forums, programs and a broad range of services. Its members span the Philadelphia, Delaware and New Jersey tri-state area and include Irish based companies with strong interests in this region.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs in excess of 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group’s US Financial Controller Appointed to Irish American Business Chamber & Network (IABCN)’s Board of Directors appeared first on Almac.

Veeva Systems Inc.: Veeva Announces Partner Approach for Best-in-Class Randomization and Trial Supply Management

admin — Wed, 01 Nov 2017 16:29:30 +0000

Vault EDC combined with IRT software will help improve data quality and speed study execution for the most complex clinical trials.

PLEASANTON, Calif.–(BUSINESS WIRE)– Veeva Systems (NYSE: VEEV) today announced it will partner with leading interactive response technology (IRT) vendors to provide advanced randomization and trial supply management capabilities with Veeva Vault EDC. Veeva is bringing together a modern EDC cloud application with best-in-class randomization and trial supply software to help the life sciences industry improve data quality and accelerate execution when managing complex clinical trials. Veeva’s open partnership approach will allow customers to use Vault EDC with the IRT solution that best meets their needs.Veeva will work with an ecosystem of highly specialized solutions like 4G Clinical, Almac Group, Bracket, IDDI, and YPrime to support sophisticated, adaptive trial designs. Customers will be able to assign patient treatments and supply investigator sites, while ensuring that accurate data flows seamlessly with Vault EDC to streamline trial design and execution. Veeva will also offer stratified randomization as a core capability in Vault EDC.

‘Veeva is committed to customer success and making it easier for companies to use Vault EDC with the software of their choice to manage randomization and their global supply chains,’ said Richard Young, vice president of Vault EDC.

‘Combining a modern EDC application with advanced randomization and supply management will help us ensure we have quality data output for our most sophisticated trials,’ said Kelly Ritch, vice president, clinical trial operations, IND 2 Results. ‘The ability for EDC and IRT solutions to work together is critical to implementing complex study designs with greater speed and efficiency.’

Veeva Vault EDC is a flexible, modern cloud application that helps life sciences companies easily design studies, manage amendments, and improve the speed and quality of data collection in clinical trials. Vault EDC is part of the Veeva Vault Clinical Suite, which also includes Vault eSource, Vault CTMS, Vault eTMF, Vault Study Startup, and Vault SiteExchange, to streamline clinical operations and clinical data management.

Market Response to Veeva’s Approach

At a recent Veeva partner event, leading IRT vendors shared their thoughts on the opportunity to combine their advanced randomization and supply management capabilities with Vault EDC:

‘4G Clinical is excited about Veeva Systems’ partner approach with Veeva Vault EDC and our Prancer RTSM solution,’ said 4G CEO Dave Kelleher. ‘As the need for speed and flexibility for complex trials increases, it is critical to align with other organizations that support our commitment to bring crucial medicines to those who need them faster.’

‘Almac is proud to collaborate with Veeva on this innovative open partnership approach to offer clients greater flexibility and data quality,’ said George Tiger, vice president of global business development, Almac Group. ‘We look forward to working closely with the Veeva team going forward.’

‘Integrating with EDC and other eClinical systems is an essential component of how Bracket designed our clinical IRT platform,’ said Jim Primerano, GM, eClinical, at Bracket. ‘We are excited about the opportunity to work with Veeva to give their customers a comprehensive solution for their clinical trials.’

‘The seamless integration of modern EDC and IRT solutions is key for the successful conduct and quality delivery of complex clinical trials,’ said Damien Tremolet, CEO of IDDI.

‘It’s exciting when two companies with significant complimentary expertise come together to make things easier for the customers we serve,’ said Shawn Blackburn, CEO of YPrime.

Additional Information

For more on Veeva Vault EDC, visit: veeva.com/VaultEDC

Stay updated on the latest Veeva news on LinkedIn: linkedin.com/company/veeva-systems

Follow @veevasystems on Twitter: twitter.com/veevasystems

Like Veeva on Facebook: facebook.com/veevasystems

About Veeva Systems

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 550 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit veeva.com.

Forward-looking Statements

This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions, particularly in the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, ‘Risk Factors’ and ‘Management’s Discussion and Analysis of Financial Condition and Results of Operations,’ in the company’s filing on Form 10-Q for the period ended July 31, 2017. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.

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Almac Group Announces Acquisition of BioClin Laboratories

admin — Wed, 01 Nov 2017 12:00:28 +0000

Significant global expansion of existing analytical services

Craigavon, N.I., 01 November 2017 – Almac Group, the global contract development and manufacturing organisation, today announced the acquisition of 100% shares of BioClin Laboratories, an independent and privately owned organisation based in Athlone, Ireland.

Established in 2002 and located in Garrycastle, just two hours away from Almac Group’s Headquarters in Northern Ireland, BioClin is internationally recognised for providing expert analytical services including cGMP pharmaceutical and biopharmaceutical analysis, GMP microbiology testing and GLP bioanalysis. The company also boasts Ireland’s leading GLP certified (INAB), cGMP certified (HPRA) and FDA registered contract laboratory.

BioClin’s bespoke 14,000sq ft modern facility significantly increases Almac’s analytical capacity and perfectly complements its existing business enabling strategic expansion and greater ability to serve clients’ needs globally. The acquisition will see BioClin’s analytical experts join Almac Sciences’ strong network of almost 600 employees across multiple sites in Europe and North America.

Almac also recently completed significant expansion of its existing analytical facilities at its global headquarter site in Northern Ireland with the creation of a new, bespoke, MHRA approved laboratory.

News of this acquisition comes just days after announcing a multi-million pound expansion of Almac owned, Arran Chemical Company, also based in Athlone, which substantially increased Almac’s manufacturing capacity for fine chemicals, pharmaceutical intermediates and advanced building blocks.

“We are delighted to announce this acquisition demonstrating further commitment to strategic growth and development of our global business.” stated Dr Stephen Barr, Managing Director, Almac Sciences. “Adding BioClin’s highly complementary analytical capacity and technical expertise to our existing capabilities, we are able to broaden our service offerings and address our global clients’ growing demands for a high quality, integrated, efficient service. We look forward to working with the BioClin team and plan to invest significantly in this facility.”

Mary Burke, Managing Director, BioClin Laboratories commented “We are very pleased to join Almac. With our shared values for outstanding quality, expertise and innovation we see this as an excellent strategic fit for BioClin enabling us to expand and deliver an enhanced range of analytical solutions to an international client market.”

End

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

About BioClin Laboratories

BioClin was established in 2002 and is internationally recognised for providing expert analytical services and rapid reporting of data to support drug development and product release. Its breadth of scientific experience and knowledge across a wide range of techniques, enables it to develop optimal methods that can be relied upon to run efficiently and meet regulatory requirements. BioClin joined Intertek Plc in February 2008 followed by a management buy-out on the 1st May 2013

BioClin is Irelands leading GLP certified (INAB), cGMP certified (HPRA) and FDA registered contract laboratory. BioClin maintains this position due to its versatility and capacity to integrate its exceptional technical expertise and quality management with a range of related services, enabling it to offer a complete range of development services to its clients.

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Almac Group Introduces Accountability and Reconciliation Tracking

admin — Tue, 24 Oct 2017 13:00:32 +0000

Fully Configurable Extension of IXRS^®3 Provides End-to-End Traceability of IMP

Souderton, PA – 24 October 2017 – Almac Clinical Technologies, a global leader in technology-enabled solutions for managing clinical trial patient and supplies data, has extended the functionality of its industry-leading IXRS® 3 IRT platform to include Accountability and Reconciliation Tracking (ART™).

ART captures all accountability data relating to the assignment, dispensation, and return of investigational medicinal products (IMP) throughout the course of a clinical trial. The toolkit provides total control over—and visibility into—the entire chain of custody down to the individual IMP unit level. This improves trial oversight, reduces dispensation errors, and strengthens patient safety.

To conform to Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) sponsors must be able to prove that the IMP administered to patients was in a safe condition and that it was used only by subjects and according to the prescribed dose. All unused IMP must be accounted for at the end of the trial, and any discrepancies in records must be documented and explained. This process, when not supported by automation, is onerous and error-prone.

“Many trial sponsors inadvertently allow discrepancies in the accountability and reconciliation process to accumulate until the end of the trial due to paper record keeping or data accumulation from disparate sources,” explains Valarie Higgins, President & Managing Director of Almac Clinical Technologies. “So what was at best a laborious task becomes a herculean effort that often adds as much as two years to the study close-out phase. We’ve found that by building error-prevention checks into a completely digital workflow, post-study reconciliation can be essentially eliminated. Trial Sponsors can close out their studies quickly and move forward with submitting their data packages for approval faster.”

ART is designed around a consistent and intuitive workflow across the full spectrum of the trial, providing insights on a single screen. “For ART to be effective, it had to be easy for users up and down the supply chain to use,” adds Higgins. “We’ve ensured that the solution supports, rather than detracts from, their daily work. The addition of this native functionality to Almac’s existing IRT solution will help sponsors and CROs realise time savings, improve site compliance, reduce risk to patient safety, and safeguard against trial delays.”

Importantly for sponsors, ART is fully configurable. It can be deployed quickly with minimal time, regardless of the trial’s complexity or size, or the design of the IMP.

To learn more about how Almac can help to transform your clinical trial chain of custody into a work of art, please visit almacgroup.com/ART

ENDS

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, Interactive Response Technology (IVRS/IWRS) through to commercial-scale manufacture.

The post Almac Group Introduces Accountability and Reconciliation Tracking appeared first on Almac.

Queen’s University Belfast in Collaboration with Almac Group Lead Largest Study of its Kind to Transform Prostate Cancer Treatment

admin — Mon, 23 Oct 2017 07:45:42 +0000

Queen’s University Belfast have led the world’s largest research study using a diagnostic test developed by Almac Diagnostic Services, to better understand the biology of prostate cancer tumours, which could lead to a transformation in how prostate cancer is diagnosed and treated.

Whether a prostate cancer patient has a slow-growing or aggressive tumour will affect the type of treatment required. It is only through understanding the type and genetics of the particular cancer tumour that clinicians will be able to put an effective treatment plan in place.

Lead researcher, Dr Suneil Jain from the Centre for Cancer Research & Cell Biology at Queen’s University Belfast explains: “Current diagnosis of prostate cancer involves biopsies, scans and blood tests to determine how aggressive the cancer is and subsequently to develop an appropriate treatment plan. Doctors repeatedly report that these tools aren’t always effective in determining how aggressive the cancer is, which can mean it is difficult to decide on the best treatment for an individual patient.”

Global Personalised medicine company Almac Diagnostic Services has developed a gene expression biomarker, known as Metastatic Assay, which aims to identify prostate cancer patients with aggressive disease. The test analyses the genetics of the tumour enabling clinicians to understand the type of tumour, whether it is a slow-growing or aggressive and if the latter, to what extent.

Researchers at Queen’s University Belfast led the world’s largest study of this kind, using Metastatic Assay on prostate biopsies from 248 patients who had previously been treated for prostate cancer. The research findings, published in Annals of Oncology, found the diagnostic test to be more effective than the standard clinical tests.

Professor Richard Kennedy, Global VP and Medical Director at Almac Diagnostic Services and McClay Professor in Medical Oncology at Queen’s University Belfast commented: “The assay has now proven to be superior to conventional clinical tests at predicting aggressive disease in two independent studies, the first of which used surgical tissue, while this study used tissue taken from needle biopsy. We believe it will play an important role in identifying men who may benefit from treatment intensification.”

Treatment options available to prostate cancer patients include radiotherapy, chemotherapy, brachytherapy and hormone therapy. Although radiotherapy is often used to effectively treat patients with prostate cancer, 20- 30% of patients can relapse within five years. Dr Jain explains: “The relapse of many prostate patients could be avoided through undergoing more intensive treatment including higher dosages of radiotherapy. There are also potential side-effects associated with administering more intensive treatment so a test that enables us to deliver the right treatment to the right patient would be extremely beneficial in clinical practice.”

The project was funded by Prostate Cancer UK and the Movember Centre of Excellence, a joint venture between Queen’s University Belfast and academic colleagues in Manchester.

Dr Iain Frame, Director of Research at Prostate Cancer UK said: “This research could provide clinicians with the answers they need to identify which cancers are likely to spread and give men peace of mind that the decision they make regarding their treatment is the right one. It’s still early days but it’s great to see how the work taking place at the Movember Centres of Excellence has the potential to bring about real change for men. We look forward to further results.”

Notes to Editor

1. About Almac Diagnostic Services

Almac Diagnostic Services is a global personalised medicine company focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics. Our approach to personalised medicine is poised to change the way that medicines are developed, regulated and prescribed. We partner with biopharma companies to provide solutions ranging from pre-clinical biomarker discovery to companion diagnostic development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited lab. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

An emphasis on scientific and technological excellence combined with a committed and passionate multi-functional team, puts Almac Diagnostic Services in a leadership position to take companion and other diagnostic tests all the way through development and to commercialisation.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs in 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

almacgroup.com

2. The Movember Centre of Excellence is based within the Centre for Cancer Research and Cell Biology (CCRCB) at Queen’s University Belfast. The Movember Centre of Excellence was launched in 2014 in partnership with Prostate Cancer UK. The Belfast-Manchester centre specifically aims to improve outcomes for men living with advanced disease.

For further information visit: prostatecanceruk.org/research/

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Almac Group Announces Successful MHRA Inspection at Charnwood Facilities

admin — Mon, 23 Oct 2017 07:30:10 +0000

Craigavon, N.I., UK, 23 October 2017 – Almac Group, the Craigavon-based global contract pharmaceutical development and manufacturing organisation, is pleased to announce the successful inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of its new Pharmaceutical Development & Manufacturing facilities at Charnwood Campus, Loughborough.

In November 2015, to meet ongoing client demand, Almac Group announced the expansion of its pharmaceutical development & manufacturing services with the acquisition of a significant proportion of the 70-acre Charnwood Campus in Loughborough, England – a world-class science, technology and enterprise park. Since that announcement the facilities have undergone significant investment both in building enhancements and the installation and validation of new processing and analytical technology.

This successful MHRA inspection provides Almac Pharma Services with the necessary licenses to develop, manufacture and pack non-potent and potent, solid oral drug products for clinical trials and commercial supply at the Charnwood site, with the new facility complementing the existing development & GMP services offered from the company’s Craigavon NI Headquarters.

Trevor Clarke, Global Head of Quality Systems commented, “We are extremely pleased with the successful roll-out of our Global Quality Management System to the new Charnwood site. This positive endorsement by the MHRA provides our clients with increased capacity governed by the same pharmaceutical quality system which they are already familiar with at our existing sites in Craigavon, Northern Ireland and Audubon, Pennsylvania.”

Graeme McBurney, Managing Director, Almac Pharma Services commented: “This is a great achievement and positive reflection of both the investment Almac has made in the site and of our staff operating the facilities. We are looking forward to beginning work for our clients at these world class facilities and already have committed projects which will commence in the coming months.”

Ends

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac Group Announces Successful MHRA Inspection at Charnwood Facilities appeared first on Almac.

The Search is on for ‘Northern Ireland’s Top Science Students

admin — Wed, 18 Oct 2017 07:31:31 +0000

Craigavon, N.I., 18 October 2017 – The search is on for Northern Ireland’s top science students who will be recognised by awards set up in the memory of two of Northern Ireland’s most famous and forward-thinking scientists.

The Trustees award the Hans Sloane Medal to the top student obtaining the highest combined marks in biology, chemistry and physics at ‘A’ level.

The Trustees, and National Museums NI are delighted to welcome a major partnership with Almac Group, the Craigavon based contract development and manufacturing organisation. This partnership will not only increase the cash awards given to the top three ‘A’ level students but establish a new award for Northern Ireland’s brightest at GCSE.

The ‘Sloane McClay Award’ commemorates the lives of both Sir Hans Sloane and Almac founder, inspirational entrepreneur and philanthropist Sir Allen McClay (1932-2010), whose vision was for Almac to be the leader in the generation of superior solutions for the advancement of human health. It will be awarded to the top student at GCSE obtaining the highest combined marks in biology, chemistry, physics and maths.

Both Sir Hans Sloane and Cookstown-born Sir Allen McClay were inspired by science to improve people’s quality of life and their values are inspirational to many. They both used their talents, time and wealth to help others and were recognised for their contributions to the world of healthcare with knighthoods.

Schools’ principals will receive a letter from National Museums NI and Almac, on behalf of the Hans Sloane Trustees, inviting them to nominate their top performing students by 17 November. Winning students and their families will be invited to attend a prestigious awards ceremony at the Ulster Museum in January, to recognise their achievements. The top ‘A’ Level student will receive the Hans Sloane bronze medal. The inaugural Sloane McClay Award will be presented to the top GCSE student. Cash awards and certificates are made to the top three students at both ‘A’ Level and GCSE.

Stephen Barr, President & MD Almac Sciences commented “We are delighted to partner with the prestigious Hans Sloane Trust to recognise and reward top performing students in key subject areas including science and maths. As a global organisation we rely on the talent and expertise of our employees and we must continue to encourage and engage the next generation of scientists to drive growth. It is our hope that recipients of both the Hans Sloane Medal and the Sloane McClay Award will continue to make a difference to knowledge, understanding and society in the same way Sir Allen McClay and Sir Hans Sloane did.”

Dr Jane Wilde, Chairman Hans Sloane Memorial Fund stated: “We are delighted to work in partnership with Almac, to support the Hans Sloane Medal and create the new Sloane McClay Award. Adding a new Award at GCSE is a very exciting opportunity to recognize the achievements of younger students. We are also grateful to CCEA who assist us with information from local examinations and school Principals, who can nominate students taking alternative examination boards.”

Kathryn Thomson, Chief Executive of National Museums NI, said: “Hans Sloane contributed significantly to scientific knowledge and was renowned for his love for learning and his quest for deeper knowledge and understanding, something that we are particularly passionate about here at National Museums NI.

“In partnership with Almac, we are thrilled to celebrate the achievements of young people who strive for scientific excellence and look forward to welcoming the winners of the awards to a ceremony at the Ulster Museum in January.”

END

Notes to Editor

A level student with the highest combined score in biology, chemistry and physics

1^st Prize winner receives the Hans Sloane Bronze Medal, a certificate and a cheque for £500
2^nd Prize winner receives a certificate and a cheque for £300
3^rd Prize winner receives a certificate and a cheque for £150

GCSE Student with the highest combined score in biology, chemistry, physics and maths

1^st Prize winner receives the Sloane McClay Award, a certificate and a cheque for £250
2^nd Prize winner receives a certificate and a cheque for £150
3^rd Prize winner receives a certificate and a cheque for £50

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post The Search is on for ‘Northern Ireland’s Top Science Students appeared first on Almac.

Almac Pod™ – Changing the Global Dynamics of Temperature Controlled Shipping Solutions

admin — Mon, 16 Oct 2017 12:49:11 +0000

Introducing a new product to the US clinical trial supply marketplace

Craigavon, N.I., UK, 16 October 2017 – Almac Group, the global contract development and manufacturing organisation, has recognised the need for a change in dynamics of temperature controlled shipping with the launch of its new Almac Pod™ service solution in the United States.

Understanding the cost, logistical and compliance challenges posed by this changing environment, the Almac Pod was originally released in Europe and serves as a first-to-market service solution. The innovative solution incorporates the efficiencies of the Almac-approved, global courier network and advanced phase change material technology (PCM) to create a temperature-controlled shipping service solution that eases the burden for its global clinical supply customers.

The Almac Pod offers a Protected, Optimised and Dynamic solution which safeguards customers’ products and mitigates against temperature excursions of all clinical shipments– the perfect solution for biologics or difficult to handle products. Since launching the service, the Almac Pod has been 100% effective in protecting the integrity of shipped products with no known temperature excursions within the shipper qualification period.

Leon Supplee, Director of Logistics, Almac Clinical Services, commented: “On the cusp of our success launching the Almac Pod in Europe, we have expanded our new temperature-controlled shipping service solution to the United States and internationally. Our customers continuously need a solution to keep pace with rapidly growing demand for controlled temperature shipments. With increased volume, the Almac Pod allows us to build on our streamlined clinical trial supply chain. The service has equipped us, and our clients, to work seamlessly across the logistics process by protecting temperature controlled products and compares more effectively than traditional water-based solutions. The Almac Pod is fully GDP-compliant and is available as part of Almac’s end-to-end, global supply chain management solution – your product, safe in our hands.”

For further details on the Almac Pod, download the whitepaper: Changing the Dynamics of Temperature Controlled Shipping Solutions here.

Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Pod™ – Changing the Global Dynamics of Temperature Controlled Shipping Solutions appeared first on Almac.

Hurricane Ophelia: Almac Group Update

admin — Mon, 16 Oct 2017 10:48:19 +0000

In anticipation of the impact expected by incoming Hurricane Ophelia, and in the interests of employee safety, Almac Group has closed its Northern Ireland operations on 16^th October. It is planned that business will resume as normal on Tuesday 17^th October.

Almac is committed to continuity of supply for our clients and customer service excellence and will endeavour to mitigate any significant impact due to this short closure.

Impact on clinical shipments

There has also been significant disruption to flights and sea crossings scheduled to depart from Northern Ireland and Ireland.

The cancellation of air and sea routes from Belfast / Dublin has impacted clinical supply shipments managed through Almac. Due to this temporary disruption, Almac have taken the decision to suspend all shipments on Monday 16^th Oct to minimise the risk of any further delays.

Almac are working closely with our Courier partners to reduce any impact and have arranged for these shipments to be collected and despatched throughout Tuesday 17^th Oct. Shipments due to be despatched on Monday 16^th Oct may incur up to a 24 hour delay.

If you have any concerns or critical shipments that need to be prioritised please contact our monitored helpdesk at logisticsservices@almacgroup.com

The post Hurricane Ophelia: Almac Group Update appeared first on Almac.

Almac Group Wins Export Achievement Award at the Pharma Industry Awards

admin — Fri, 06 Oct 2017 08:01:51 +0000

Craigavon, N.I., 06 Oct 2017 – Almac Group, the global contract development and manufacturing organisation has won the Export Achievement award at Ireland’s Pharma Industry Awards.

The award recognises the Group for an effective and rewarding export strategy, which demonstrated commitment to expand its global business.

An independent panel, which comprised 13 industry leaders, judged the entries and determined the winners based on a number of key attributes. Almac triumphed over the competition and clearly demonstrated its effective and innovative Goods Distribution Practice (GDP) strategy, how it implemented an efficient, cost effective and environmentally responsible approach to exporting, how the company engages with suppliers and the efforts to increase brand awareness in international markets. It was one of 22 awards presented to Ireland’s laboratory industry.

Alan Armstrong, Chairman and CEO Almac Group, commented: “We are delighted to receive this recognition from the Pharma Industry Awards. With 15 facilities and over 60 depots throughout the world, Almac continues to respond to industry demand by expanding our capacity and offer in-country expertise direct to our clients. This award is testament to the skill and innovation of our employees and we will continue to pride ourselves on our ability to provide high quality, flexible and innovative solutions to meet our global clients’ requirements.”

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, Interactive Response Technology (IVRS/IWRS) through to commercial-scale manufacture.

The post Almac Group Wins Export Achievement Award at the Pharma Industry Awards appeared first on Almac.

Almac Group Leads Economic Growth in Pennsylvania and the U.S.

admin — Wed, 13 Sep 2017 10:11:03 +0000

Featured in NBC10 News Segment entitled Growing Greater Philadelphia

Souderton, PA, US, 13 Sep 2017 – Almac Group, the global contract development and manufacturing organisation, receives the spotlight for its long-term commitment to expanding its footprint in the greater Philadelphia region. This has been achieved through continued reinvestment allowing the company to flourish to more than 5,000 personnel internationally and operating five locations in the U.S., including its North American headquarters in Souderton, PA, housing over 1,450 staff from the company’s Clinical Services, Clinical Technologies and Sciences business units.

The Greater Philadelphia Chamber of Commerce’s Select Greater Philadelphia Council, in coordination with NBC10/Telemundo62, created the Growing Greater Philadelphia television program to highlight unique job creators and business success stories in the region. The program shines a spotlight on innovative ways companies, like the Almac Group, are driving economic impact and advancing diverse products and services in the marketplace.

The segment aired on Tuesday, September 12th at 7:00 pm EST on NBC10 during the evening news hour.

The Philadelphia Metro Area recently jumped to Top-5 on JLL’s Life Sciences Outlook | 2017 report, citing the region as a “breakout cluster making strides in life sciences through new development and a growing scientific community.”

Valarie Higgins, President & Managing Director of Almac Clinical Technologies, commented: “Almac Group is much more than a pharmaceutical services company, we are a diverse and skilled family committed to a shared vision. By working in unique facets of the pharmaceutical lifecycle, our employees contribute to improving the client experience every day. We are fortunate to attract and cultivate an incredibly talented workforce and enjoy some of the highest employee retention and satisfaction rates in the industry. By continually investing to improve our best in class services, we ensure that we can always provide the high quality premium solutions that our clients, across Pennsylvania, the U.S., and throughout the globe, count on us for.”

To find out more and to watch the segment below:

Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The post Almac Group Leads Economic Growth in Pennsylvania and the U.S. appeared first on Almac.

Almac Group Announces US Workshops Targeting EU Product Launch Best Practices

admin — Thu, 10 Aug 2017 14:23:09 +0000

Craigavon, N.I., UK, 7 Aug 2017 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce two free, one-day exclusive knowledge sharing events titled “Almac Product Launch Workshop” on Tuesday, September 26^th at the Andaz Hotel in San Diego, CA and on Thursday, September 28^th at the DoubleTree by Hilton Hotel, Downtown Boston, MA.

These complimentary workshops will discuss key aspects regarding launching a product into Europe with a focus on niche and orphan drugs, including:

European regulatory framework
The importance of the role of the Qualified Person (QP)
Key considerations for packaging, selection and design
Strategies for stock optimization
Managing a complex EU supply chain
Considerations for a temperature sensitive product

A number of Almac’s subject matter experts, including Head of BD (Europe), Brian Eastwood, will join key thought leaders from McGee Pharma International, Vertex Pharmaceuticals and Optel Vision to share real world experiences and provide unique advice gained in their respective fields of expertise.

The information presented during these free workshops will guide attendees through the EU launch process, from submitting an MAA, to final distribution of drug product to the end-user. Attendees will leave the workshops with a wealth of advice and be better prepared for what is ahead to ensure their commercial launch is successful.

With over 40 years’ experience, Almac is an FDA and EU approved outsourcing partner to the global pharmaceutical and biotechnology industries. In the last three years alone, the company has supported the successful launch of more than fifteen first-to-market orphan drug products.

Brian Eastwood commented: “Companies face a number of challenges when launching a product into Europe for the first time. Almac understands the complexities involved in the entire end-to-end process and these complimentary workshops are an opportunity for us, in partnership with key industry leaders, to share our expertise, advice, and knowledge in a range of pertinent areas in this field.”

To find out more and to sign up, visit: EU Product Launch Workshop Agenda.

Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The post Almac Group Announces US Workshops Targeting EU Product Launch Best Practices appeared first on Almac.

“Portadown Gets Active” A scheme to support local children and end holiday hunger

lorrainemcclay — Thu, 10 Aug 2017 10:49:29 +0000

Children in Northern Ireland has just launched a scheme to support local children in Portadown. The programme is being delivered in partnership with the community and voluntary sector, statutory agencies, local schools and local government with additional support from Craigavon based Almac Group.

The “Portadown Gets Active” programme will run throughout August and is designed to encourage young people aged between 8 and 11 to stay active during the summer months and help them understand the importance of healthy living by providing them with the skills and confidence to cook simple nutritious meals on a budget.

The programme is being held in Presentation Primary School to make the most of the school estate which would otherwise lie empty during the summer holidays.

The project was created in response to evidence that many families face severe difficulties during holiday periods when free school meal entitlement ends. It not only provides a healthy snack and lunch, but also gives children the opportunity to take part in a range of activities and gain an OCN qualification in Healthy Living. A total of 70 children are taking part in the programme with a further 20 older children having already taken part in a Mentoring Programme.

Pauline Leeson, Chief Executive of Children in Northern Ireland said:

“For some families, particularly those who receive free school meals, the school holidays can be a struggle. It’s not just the increase in food cost but the pressures associated with keeping children active.”

Alan Armstrong, CEO, Almac Group said: “The opportunities created by this programme are to be greatly welcomed. It is great to see us all pull together to ensure these children receive the education and support they need to guarantee they have the skillset and ability to prepare decent, nutritious meals now and into the future. We are proud to be supporting this initiative to help unlock the potential of all children and young people no matter where they grow up.”

The project in Portadown is a partnership between Oasis Youth Portadown, Children & Young People’s Strategic Partnership, Pathways Activities and Presentation Primary School with additional support from the Public Health Agency, food supplier Brakes UK and the Almac Group.

ENDS

NOTES FOR EDITORS

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally.

Pathways is the youth engagement delivery team for the Reserve Forces & Cadets Association for Northern Ireland. The team delivers across all communities throughout Northern Ireland, has been in existence for 2 years and has delivered 62,350 places, primarily to the primary and post primary education sectors as well as a variety of community groups.

Meals & More is a charitable programme run by Brakes UK, it works with suppliers and delivery partners to provide holiday clubs across the UK.

The post “Portadown Gets Active” A scheme to support local children and end holiday hunger appeared first on Almac.

High-demand IT skills being developed at innovative summer camp

admin — Mon, 07 Aug 2017 08:34:39 +0000

Novosco Cloud Camp in partnership with Almac Group returns

The IT engineers of tomorrow are being ‘hothoused’ at an innovative IT infrastructure summer camp this week (7th – 11th August 2017).

Following its successful first year in 2016, Novosco Cloud Camp in partnership with Almac Group returns this week at Belfast Metropolitan College’s Titanic Quarter Campus.

The five-day summer camp, which is free to students aged 16-17 who are enrolled at schools and colleges throughout Northern Ireland, provides first-hand experience in the management and development of IT infrastructure in a fun learning environment.

Professional IT engineers and Belfast Met lecturers are facilitating the camp, which also includes a tour of Novosco’s headquarters at Catalyst in Belfast to allow students to see a world-class managed cloud company in action.

In addition to free registration, all participants are being provided with a free Raspberry Pi computer to keep.

Areas being covered at Novosco Cloud Camp include: networking, Python programming, basic HTML programming, and creating virtual servers.

At the end of the camp, students can keep their individual Raspberry Pi mini computers to continue practicing and honing the skills learned at the camp.

Novosco Managing Director, Patrick McAliskey, said: “Cloud Camp was a real success in 2016 and again we’ve had a big response this year in terms of applicants. We know that there is demand for IT skills in Northern Ireland and that this will grow. But it is evident from the registrations we’ve had in Cloud Camp that there is also real interest in IT careers.

“At Novosco we work hard to develop and retain the expertise we have, but with that comes the responsibility to support the development of the next generation of IT infrastructure engineers, skilled cloud technicians and future project managers. Novosco Cloud Camp is just one part of our commitment to supporting the future of the industry and growing the talent pool in Northern Ireland.

“We are delighted to be working with Almac Group and Belfast Met once again, who too share our commitment to developing the skills of the future in Northern Ireland.”

Andrew Hillis, Group Head of Information Services at Almac Group, commented: “Providing an extensive range of integrated services to the pharmaceutical and biotech sectors globally is built upon sound IT infrastructure. Some of the skills that young people are learning at Cloud Camp are crucial to the day-to-day operations of our international organisation. We’re thrilled to play our part alongside Novosco to stimulate interest in IT and encourage potential future employees.

Belfast Metropolitan College’s Principal and CEO, Marie-Thérèse McGivern, added: “It is a privilege to once again host the Novosco Cloud Camp, in partnership with Almac Group, this summer at our Titanic Quarter Campus.

“The college has a rich history in delivering comprehensive courses in ICT and guiding students along the path to future employment for some of Northern Ireland’s leading companies. We are really looking forward to welcoming this year’s campers and supporting them on their informative journey using our excellent facilities and top-class lecturers working alongside Novosco’s talented IT infrastructure engineers.”

Novosco is a managed cloud provider with clients in the public, private and voluntary sectors across the UK and Ireland, including Premiership football teams, police forces, some of the UK’s largest health trusts and many of Northern Ireland’s top companies.

Employing 150 people, Novosco has offices in Belfast, Manchester, Dublin, and Cork.

Novosco was recently shortlisted for ‘Best Cloud Support Provider’ in the 2017 Computing Cloud Excellence Awards – the only Northern Ireland company to make the shortlist.

For more information on Novosco, visit novosco.com.

For more information on the Novosco Cloud Camp, in partnership with Almac Group, visit novoscocloudcamp.com.

ENDS

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Lismore Comprehensive Represents Northern Ireland in Young Enterprise UK final

admin — Mon, 03 Jul 2017 07:06:15 +0000

Craigavon, N.I., 3 Jul 2017 – A group of innovative pupils from Lismore Comprehensive is representing Northern Ireland in London this week as they pitch their novel product in the UK final of the Young Enterprise Company of the Year competition.

The group from Year 13 who make up the team called “Never Lace” will be representing Northern Ireland. They have recently been supported in their preparation for the final by Senior Executive members from Almac Group and Danske Bank by sharing their expertise in areas including innovation, marketing, teamwork and presentation skills.

They will be competing against 13 other schools from across the UK. Each group will present their business ideas at the British Film Institute on Thursday 6th July.

Never Lace will be pitching a novel product which enables laces to be easily secured within a light magnetic buckle so that users need never tie their laces again.

The Lismore Comprehensive team members are Conall Brady, Dean Conway, Jamie Leighton, Jordan Greene, Michael Judge, and Se Kelly and will be accompanied to London by their Business Studies teacher and mentor, Mr Francis McVeigh who has directed the group through the entire process. Lismore’s Principal, Mrs Fiona Kane and Mrs K Adams, Governor Chair, will also provide support during the trip.

Conall, Managing Director Never Lace, explained how the idea had come about: “One of our teachers told us about how their four year old son had his laces untied and they got caught when he was going up a moving escalator. It was a traumatic experience for him and his family and we knew there was an opportunity to try to find a solution to this problem. We carried out market research and knew we had discovered a gap in the market that we had to act upon. We researched the product from a safety perspective as we knew it could be beneficial to children, the elderly and to sportspeople. Through working with Almac we have learnt so much about the range of skills needed to run a successful business as well as gaining confidence to go to London and pitch alongside some of the most innovative young teams in the UK.”

Never Lace is soon going to be stocked in Debenhams at Rushmere Shopping Centre in Craigavon after a successful pitch made by the team. The medium sized pharmacy, Northern Pharmacies with outlets across Northern Ireland have also issued a contract and are selling the Never Lace product. Local schools including Special Schools and care homes have also bought the product and Linfield footballer Roy Carroll, who has also played for Manchester United, is now using the product on the pitch, attracting much interest from his team mates who are also keen to use it.

Mr McVeigh commented, “This has been a fantastic inspirational journey, not only for students and their families, but for the entire school community. Students have gained entrepreneurial knowledge and developed many skills and qualities from their experiences. These young entrepreneurs are a strong, talented group of friends who have turned business partners and have started something special.”

Oonagh Murtagh, Head of South Business Centre at Danske Bank, said: “I really enjoyed working with this brilliant group of students as they prepared for the chance to pitch their exciting product at the Young Enterprise UK final. It is a fantastic achievement to have reached this level and hopefully the feedback and advice we as mentors gave them during our sessions will stand the team in good stead for their presentation. Danske Bank is always keen to support entrepreneurship and to encourage innovation, particularly amongst the many talented young people we have at schools right across Northern Ireland. The bank congratulates Lismore Comprehensive and the Never Lace team on reaching this stage of the competition and I wish them all the very best as they compete against the schools from other parts of the UK.”

Kevin Reid, VP of Corporate Marketing at Almac, said: “I have personal experience with the fantastic work undertaken by Young Enterprise and am aware how great an opportunity it is for these pupils to go to London and pitch their novel product. They are promoting an exciting product and are running a financially successful company which is worthy of high praise. But they also have overcome challenges along the way, finding solutions to problems that many businesses face and they have learned that continuous improvement, application of skills and innovation are all essential to business success. We congratulate them for reaching this stage of the competition and wish them the very best as they head to London. As one of Northern Ireland’s leading companies in the field of innovation we are delighted to be able to share our expertise with local schools and start-up businesses and help support the next generation of entrepreneurs.”

ENDS

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over almost 50 years and now employs in 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Lismore Comprehensive Represents Northern Ireland in Young Enterprise UK final appeared first on Almac.

Petya ransomware attack – Almac update

admin — Fri, 30 Jun 2017 13:27:43 +0000

As previously notified, Almac systems remain unaffected by the Petya ransomware attack.

Due to the ongoing issues being experienced by TNT air freight, Almac is achieving normal service (including full track and trace) for all outbound shipments through the use of our alternative Courier Service providers. We will also work to close any legacy issues directly with TNT air freight and secure Proof of Delivery for shipments affected to date.

Updates will continue to be provided by your Almac Project Leader / Manager as appropriate.

Almac is committed to continuity of supply for patients and customer service excellence and will endeavour to mitigate any impact due to this current situation.

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Almac Group scoops top prize at Made in the UK Awards

admin — Fri, 23 Jun 2017 12:45:25 +0000

Craigavon, N.I., 23 Jun 2017 – Almac Group, the established contract development and manufacturing organisation, has been recognised as the UK’s top manufacturer in the Medical/Life Sciences and Healthcare industry at the Made in the UK Awards.

As a result of being selected as the regional winner in the Made in Northern Ireland Awards, presented on 12^th May in Belfast, Almac Group was automatically entered to compete in the Made in the UK Awards as Northern Ireland’s representative for the category. Almac Group beat off strong competition from Crawford Healthcare, North West and Tissuemed, Yorkshire.

The event, which welcomed over 500 manufacturers from across the UK, was held on Thursday 22^nd June 2017 in the Titanic Hotel, Liverpool.

The ceremony organisers, Insider Media, designed the awards to recognise and reward manufacturing companies based in the UK which have demonstrated success in innovation, product development and growth in either domestic or overseas markets.

Kevin Reid, VP Corporate Marketing, who collected the award during the prestigious ceremony commented: “Almac Group are delighted to be named as the top UK manufacturer in the Medical/Life Sciences and Healthcare industry. We aim to ensure our products and services are innovative and of the highest quality for our global customer base. This award is testament to the commitment, talent and expertise of our colleagues, each of whom are dedicated to our vision to advance human health worldwide.”

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac Group scoops top prize at Made in the UK Awards appeared first on Almac.

Almac Group Recognised as a Top 50 Company for Transatlantic Operations

admin — Mon, 19 Jun 2017 07:20:29 +0000

Souderton, US, June 19, 2017– Almac Group, the global contract pharmaceutical development and manufacturing organisation, is delighted to have received recognition as a US-Ireland Top 50 Company for its commitment to building prosperity through business and job creation.

The Irish Echo Newspaper’s 10th Annual Awards Luncheon highlights companies who exhibit dedication to strengthening international trade between the US and Northern Ireland. The luncheon emphasises a commitment to future progress and prosperity between the citizens of New York, NY, US and Belfast, Northern Ireland, UK, while celebrating a shared history and past.

Almac received the award by demonstrating long-term growth by expanding venture in its US and Northern Ireland operations and investing more than $56 million combined, which will create more than 700 full-time jobs. As a result of this investment, Almac’s global headcount will increase to over 5,000 by the end of 2017. These expansions are supported by the Office of International Business Development, Pennsylvania Department of Community & Economic Development, and the Department of Jobs, Enterprise and Innovation through IDA Ireland, The Republic of Ireland’s inward investment promotion agency.

Mark Weir, US Group Financial Controller, commented: “At a time when our commitment to expanding operations in the US and Northern Ireland is strong, we are delighted to receive recognition as a US-Ireland Top 50 Company. By broadening performance and job opportunities, Almac is dedicated to mutual growth. Our company’s history is shaped by relationships and they remain fundamental to Almac’s future.”

This worldwide recognition showcases Almac’s mission in ‘partnering to advance human health’ by making continued investments into the communities it serves. Almac understands its advantage by offering industry-leading products and services to broaden the Group’s impact in the US, Northern Ireland, and worldwide.

To find out more about this award and request a meeting or information e-mail media@almacgroup.com.

Ends

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown almost 50 years and now employs in excess of 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Recognised as a Top 50 Company for Transatlantic Operations appeared first on Almac.

Almac Group Awarded U.S. Patents for Ground-breaking “DDRD” Assay

admin — Tue, 13 Jun 2017 08:50:36 +0000

Craigavon, N.I., 13 June 2017 – Almac Group’s Diagnostic Services business unit announced today it has been granted U.S. patent protection for its DNA Damage Response Deficiency (DDRD) assay. The U.S. Patent and Trademark Office (USPTO) issued U.S. Patent Numbers 9,670,547 & 9,677,140, each entitled, “Molecular Diagnostic Test for Cancer”, effective until 2031. This adds to the patent protection already granted in China, Singapore, Australia, New Zealand and South Africa for this assay.

Almac’s molecular assay detects a subgroup of patients with a defective FA/BRCA pathway, who are more susceptible to DNA damage and therefore likely beneficiaries of DNA-damage therapeutic agents such as anthracyclines and PARP inhibitors. Furthermore, DNA damage leads to the activation of a specific innate immune response pathway (cGAS/STING/TBK1/IRF3) and activation of immune checkpoint targets (such as PDL1 and IDO1), hence confirming the assay may be used to predict response to immune checkpoint inhibitors. Almac documented these findings in a study entitled “Activation of STING-Dependent Innate Immune Signalling By S-Phase-Specific DNA Damage in Breast Cancer” published by the Journal of National Cancer Institute (JNCI) last year.

“Almac has been at the forefront of RNA based genomic innovation for over 10 years and this patent is expected to be the first of many in the US and EU to protect our innovative pipeline of predictive tests,” said Professor Paul Harkin, President and Managing Director, Almac Diagnostic Services. “The biology behind the DDRD assay is now well established with the first clinical validation for predicting response to DNA damaging agents in breast cancer published in JNCI back in 2014. Further validation is planned to ensure all applications are made commercially available and the significant benefits are realised by patients in the near future.”

About Almac Diagnostic Services

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

almacgroup.com

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Almac Group Reports Pre-tax Profits of £27M

lorrainemcclay — Thu, 08 Jun 2017 14:00:13 +0000

Craigavon, N.I., 7 Jun 2017 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has reported pre-tax profits of almost £27M.

Growth in revenue for the global company was recorded at 14% higher than the previous year at £447M.

Globally, employee figures increased by 12% to 3,975. Of this total 2,650 staff are employed at Craigavon, representing an increase of 421 on the previous year.

The figures were recorded in Almac’s annual report with its results for the year ending 30 September 2016.

2015 pre-tax profit was recorded at £28M, however that year’s figures included $20M income from out-licensing oncology products and diagnostics tests developed in-house by Almac Diagnostic Services. No such R&D contribution was included in the £27M for 2016.

2016 saw significant investment on expanding Almac’s US Headquarter site in Souderton, Pennsylvania in addition to leasing new office space in nearby Lansdale in response to increased client demand for its services.

The company also recently announced a £5M investment at its Global HQ campus in Craigavon to build an additional lab and office facility whilst further considerable investment has been made in other operational sites in North Carolina, Ireland and Asia. Further investment is being planned as part of its global expansion strategy and will be announced throughout the year.

Group CEO, Alan Armstrong commented “2016 was a very successful year for Almac as we continued to deliver upon our global expansion strategy including investment of around £31 million in new facilities, equipment and resources. All our profits are reinvested into the business enabling us to offer best-in-class services and products to our clients.”

ENDS

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown almost 50 years and now employs in 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Reports Pre-tax Profits of £27M appeared first on Almac.

Almac Group Executives Share Expertise at Upcoming Industry Conferences

admin — Tue, 16 May 2017 08:10:20 +0000

Craigavon, N.I., Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced that two of its key clinical supply experts will deliver presentations at leading global conferences in May.

Heather Bogle, Supply Chain Solutions Manager, will speak at this years’ Temperature Controlled Logistics in Biopharmaceuticals conference being held in Princeton, NJ, 16-17 May 2017. Her presentation, titled “GDP Compliance: Are you keeping your cool or trending towards an excursion?” will take place at 2:00 pm on day one of the conference where she will share the stage with a growing list of other industry experts from across the globe.

During her talk, Heather will share her expertise and in-depth knowledge on a range of key considerations such as:

The impact of the GDP regulations and the latest news on inspection to prepare in advance
The challenges faced by sponsors and clinical sites when transporting and storing temperature sensitive pharmaceuticals
How new technologies can deliver effective temperature management solutions

Heather Bogle joined Almac in 2001 and has first-hand experience in managing the supply chain for studies across the globe with temperature sensitive products. She has expert knowledge on the challenges with temperature management throughout the supply chain, and extensive experience developing robust, efficient, and innovative solutions.

Caitriona Lenagh, QP Services Manager, will co-host a workshop at the upcoming Clinical Trial Supply West Coast conference being held in San Francisco, CA, 24-25 May 2017. The workshop, titled “Changes and key strategies to address QP requirements and their impact on releasing IMP in Europe” will take place at 2:15pm on day one of the conference where she will discuss how Almac continues to adapt to a changing regulatory environment in Europe.

Central to the conversation, Caitriona will share her experiences regarding Annex 16 and how this has impacted Almac’s operations, including:

Finding new ways to manage costs as a result of regulatory changes
Defining how Annex 16 will place more responsibility on Qualified Persons to ensure that supplies are being thoroughly checked with the introduction of a QP declaration
Preparing QP teams for the regulatory changes to ensure their preparedness for impending MHRA audits
Defining how Annex 16 could have a knock-on effect on other elements of supply operations, such as forecasting

Caitriona Lenagh joined Almac in 2009 and has first-hand experience in all QP requirements in the world of Global Clinical Trials. She has worked with international teams, educating and mentoring them in the requirements of EU legislation, particularly the roles and responsibilities of the Qualified Person. She has extensive experience in a number of dosage forms and has performed audits of manufacturing, testing and packaging sites throughout the world, imparting knowledge on the regulatory requirements and industry expectations.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The post Almac Group Executives Share Expertise at Upcoming Industry Conferences appeared first on Almac.

Almac Group Announces Publication of Prostate Cancer Metastatic Assay Validation

admin — Thu, 20 Apr 2017 12:53:44 +0000

Craigavon, N.I., 20 April 2017 – Almac Group’s Diagnostic Services business unit today announced the Journal of European Urology has published results relating to its Prostate Cancer Metastatic Assay. The publication demonstrates the assay can be used to analyse primary prostate cancer FFPE samples to identify a molecular subgroup with a high risk of developing distant metastases. The assay therefore has the potential to guide the choice of therapy for patients presenting with primary prostate cancer.

Professor Richard Kennedy, MD, PhD, VP and Medical Director, Almac Diagnostic Services and McClay Professor in Medical Oncology, Queen’s University Belfast commented “An unbiased discovery approach was used to identify a molecular subtype of primary prostate cancer that demonstrated metastatic biology. This approach has created a very robust assay with excellent performance, independent of clinical factors such as Gleason and CAPRA. We believe it will play a significant role in aiding clinicians to select the most appropriate therapy regimen for their patients.”

The study was conducted in conjunction with The Movember / Prostate Cancer UK funded Prostate Cancer Centre of Excellence at Queen’s University of Belfast and Manchester University along with Cardiff University, University College Dublin, Oslo University and the University of Surrey. Independent assay validation was performed using 322 radical prostatectomy samples with Metastatic Assay positive patients having increased risk of biochemical recurrence (Multivariable HR 1.62; p= 0.0092) and metastatic recurrence (Multivariable HR=3.20; p=0.0001). A combined model with CAPRA-S identified patients at increased risk of biochemical and metastatic recurrence superior to either model alone (HR=2.67; p<0.0001 and HR=7.53; p<0.0001) respectively.

“The publication of this manuscript in a journal of this calibre represents a significant milestone in the assay’s development and with two additional manuscripts being prepared for submission, further milestones are expected to be reached later this year. The first is another clinical validation but this time using biopsy FFPE tissue and the second is analytical validation to demonstrate the assay can be transferred to several commercial platforms.” said Professor Paul Harkin, President and Managing Director, Almac Diagnostic Services. He went on to say “Almac has been at the forefront of RNA based genomic innovation for over 10 years and this assay represents just one of our innovative pipeline of predictive and prognostic tests”.

About Almac Diagnostic Services

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown almost 50 years and now employs in 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Announces Publication of Prostate Cancer Metastatic Assay Validation appeared first on Almac.

Almac to Exclusively Share Global Expertise in EU Product Launch Workshop

admin — Wed, 15 Mar 2017 08:54:18 +0000

Craigavon, N.I., 15 March 2017 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce a free, one-day exclusive knowledge sharing workshop entitled ‘Considerations for EU Product Launch’ on Thursday 11 May 2017 at The Carlton Hotel Dublin.

This complimentary workshop will discuss key aspects regarding launching a product into Europe with a focus on niche and orphan drugs and will include:

European regulatory framework
The importance of the role of the Qualified Person (QP)
Key considerations for packaging, selection and design
Strategies for stock optimisation
Managing a complex EU supply chain
Considerations for a temperature sensitive product

A number of Almac’s subject matter experts, including VP Commercial Operations, David Downey, will join key thought leaders from PTC Therapeutics, Shire Pharmaceuticals and Quickstat to share real world experiences and provide unique advice gained in their respective fields of expertise.

The information presented during this free workshop will guide attendees through the EU launch process, from submitting an MAA, to final distribution of drug product to the end-user. Attendees will leave the workshop with a wealth of advice and be better prepared for what is ahead and ensure their commercial launch is successful.

David Downey commented: “Companies face a number of challenges when launching a product into Europe for the first time. Almac understand the complexities involved in the entire end-to-end process and this complimentary workshop is an opportunity for us, in partnership with key industry leaders, to share our expertise, advice and knowledge in a range of pertinent areas in this field.”

To find out more and to sign up, visit: EU Product Launch Workshop Agenda.

~ENDS~

Notes for Editors:

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information e-mail media@almacgroup.com.

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Almac Group Executives Share Expertise at Key Industry Events

admin — Tue, 14 Mar 2017 14:41:25 +0000

Craigavon, N.I., 14 Mar 2017– Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced that a number of its key clinical supply experts will deliver presentations at leading global conferences throughout March and April.

Heather Bogle, Supply Chain Solutions Manager will speak at this years’ Clinical Trial Supply Europe Conference being held in Barcelona, 15-16 Mar 2017. Her presentation, entitled “Regulatory Impact: Technology, Tools, and Insight to Mitigate Risk”, will take place at 4pm on day one of the conference where she will share the stage with a growing list of other industry experts from across the globe.

During her talk, Heather will share her expertise and in-depth knowledge on a range of key considerations such as how, today, both the drug manufacturer and the clinical sites face an increased number of challenges to stay compliant in the realm of temperature management. Heather will review real-life case studies to show how processes, technology and tools were implemented across global studies to reduce errors, improve efficiencies and improve compliance.

Olive McCormick, Head of Quality & QP will deliver a presentation on 23 March at 8.55am at the CRISP Spring meeting in San Francisco. Focusing on “Annex 16”, introduced in April 2016, Olive will discuss how the QP certification and batch release regulations have impacted clinical supplies and share her experiences in overcoming challenges associated with implementing the new requirements and how to ensure continued compliance.

In addition, on 23-24 April, Olive will join Mark Hanly, Strategic Business Analysis Manager and Paul O’Connor, Global Vice President Quality to host a number of workshops during the GCSG annual conference in New Mexico. This time Olive will focus on raising the awareness of the various regulatory labelling and custom requirements affecting clinical supplies in Asia whilst Mark and Paul will discuss a range of other pertinent clinical supply chain topics including “The benefit of integrated supply chain systems” and “Brexit and the potential impact to Clinical Supplies”.

Paul O’Connor has been with Almac Group for over 20 years and is responsible for overseeing the quality assurance, compliance and control processes, globally for Almac Clinical Services. He possesses a wealth of experience in all aspects of quality and regulatory practices and how they are applied in various regions.

Heather Bogle joined Almac in 2001 and has first-hand experience in managing the supply chain with temperature sensitive products for studies across the globe. She has expert knowledge on the challenges with temperature management throughout the supply chain and extensive experience developing robust, efficient and innovative solutions.

With extensive industry experience spanning over 20 years, Olive McCormick’s expert knowledge and deep understanding of quality procedures has established her as a thought leader in the industry.

Working with Almac for almost a decade, Mark Hanley has partnered with a number of clients to oversee key projects and drive efficiencies. He has vast experience, knowledge and expertise within project management and supply chain management including interactive response technologies.

To find out more about these events and request a meeting or information please visit: https://www.almacgroup.com/events/

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Executives Share Expertise at Key Industry Events appeared first on Almac.

Almac Diagnostic Services and EORTC Establish Collaboration for Tumour Molecular Profiling

admin — Wed, 08 Mar 2017 14:08:32 +0000

Partnership to support the discovery and development of novel biomarkers, enabling personalised medicine

Craigavon, N.I., 08 March 2017 – Almac Diagnostic Services, the global personalised medicine company, focusing on the discovery, development and commercialisation of complex diagnostic and companion diagnostic tests, has announced that it has been selected by the European Organisation for the Research and Treatment of Cancer (EORTC) as its preferred partner for molecular profiling of cancer patient samples collected by EORTC clinical trials, including SPECTA (Screening Patients for Effective Clinical Trial Access), a pan-European Cancer network.

The ambition of EORTC is to streamline patient inclusion in clinical trials of molecularly targeted treatment, gaining efficiency from reliable centralised molecular testing. In addition, EORTC seeks to standardise Next Generation Sequencing (NGS) and Gene Expression Analysis in translational research projects, enhancing reproducibility and comparability of results.

Almac Diagnostic Services will receive and process patient samples across multiple disease types from various locations across Europe, using the new Illumina Trusight Tumor 170 solid tumor NGS panel to analyse patterns of genomic variation within patient samples. The company will provide this service from its European facility in Craigavon, Northern Ireland.

The output of the analysis by Almac Diagnostic Services will contribute to the SPECTA database, which will be an invaluable resource to the Oncology community in terms of therapeutic development and identification of novel biomarkers of response and prognosis as well as diagnosis of cancer patients. This will ultimately lead to the development and commercialisation of future companion diagnostics.

Michael Sloan, VP of Commercial Operations at Almac Diagnostic Services said: “The SPECTA Programme is a unique cancer research initiative enabling personalised medicine through its key collaborations across Europe. We are proud to have been chosen by the EORTC as a partner of choice for the molecular profiling of these valuable SPECTA samples and excited by the opportunities the generation of this data will provide to improve patient care.”

Vassilis Golfinopoulos, EORTC Medical Director said: “This agreement with Almac Diagnostic Services is one of several key partnerships EORTC has established to further develop the SPECTA infrastructure. Through the Illumina Trusight Tumor 170 solid tumor NGS panel and pipeline, EORTC seeks to improve substantially all stages of therapeutic agents development, from early clinical assessment to refinement of targeted molecular indications.”

John Leite, PhD, Vice President of Oncology at Illumina said: “Illumina believes that TruSight Tumor 170 can become the standard across the industry for how cancer-relevant genetic variants are identified and, through the research done by SPECTA, lead to new diagnostics that will guide precision oncology decisions. The next step in this realization is to provide efficient access for patients to molecularly driven clinical trials. This is the goal of the collaboration between Almac Diagnostic Services and the EORTC, which Illumina fully supports.”

~ENDS~

Notes for Editors:

For more information e-mail media@almacgroup.com.

About Almac Diagnostic Services

About Almac Group
‘Partnering to Advance Human Health’

About EORTC

The European Organisation for the Research and Treatment of Cancer (EORTC) brings together European cancer clinical research experts from all disciplines for trans-national collaboration. Both multinational and multidisciplinary, the EORTC Network comprises more than 4,800 collaborators from all disciplines involved in cancer treatment and research in more than 800 hospitals in over 41 countries. A unique pan-European clinical research infrastructure, EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices through translational and clinical research.

More information: www.eortc.org

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Irish Ambassador to US will present distinguished awards to Beneficial Bank, Eileen McDonnell, and Sean Rooney

admin — Tue, 28 Feb 2017 10:41:48 +0000

Philadelphia, PA, (27 January 2017) – The Irish American Business Chamber & Network has announced the 2017 recipients of their highest awards. The Ambassador Award will be presented to Beneficial Bank, with President and CEO, Mr. Gerard Cuddy in attendance to accept the award. The Taoiseach Award honoree is Ms. Eileen McDonnell; the Uachtarán Award will be presented to Sean Rooney. The Ambassador of Ireland to the United States, Anne Anderson, will confer the awards.

The Ambassador Award is presented each year to a member company that has helped to carry out the Chamber’s mission of strengthening business and educational ties between Ireland and the United States. Past honorees include Almac Group, QVC, SAP, The Children’s Hospital of Philadelphia, Shire Plc, Aramark, The Vanguard Group, ICON Plc, Amicus Therapeutics, Siemens, Wyeth, ICT Group, GMAC Commercial Holding Corporation, and Cross Atlantic Capital Partners.

Founded in 1853, Beneficial Bank is the oldest and largest bank headquartered in Philadelphia. The Bank’s original purpose was to give Philadelphia’s growing Irish immigrant work force a safe place to keep their savings. Beneficial Bank continues this mission today, focusing on doing what is right for their customers.

The Taoiseach, or “Chieftain,” Award complements the Ambassador Award by recognising individuals of Irish decent who have exemplified leadership and compassion. The recipient of this year’s Taoiseach Award is Eileen C. McDonnell , Chairman and Chief Executive Officer of the Penn Mutual Life Insurance Company. Before joining Penn Mutual, she was president of New England Financial, a wholly owned subsidiary of MetLife, and senior vice president of the Guardian Life Insurance Company. Ms.

McDonnell is a former member of the Master of Science in Management faculty at The American College in Bryn Mawr, Pa., where she held the newly endowed chair for Women and Financial Services and was author of “Marketing Financial Services to Women.” She was honored in 2014 and 2015 in Irish America’s Annual Business 100 list and in 2016 to the magazine’s Top 50 Power Women’s list, honouring the best and the brightest Irish-American and Irish-born business leaders.

The Uachtarán, or “President’s,” Award honors Ireland’s president and that office’s tradition of building cultural and economic alliances. The recipient of this year’s Uachtaran Award is Mr. Sean Rooney, Founder of The Kelly Rooney Foundation. Sean is devoted to community and charity work. Sean started the Kelly Rooney Foundation, named after his late-wife who passed away in 2006 from breast cancer. Through partnerships with Breastcancer.org and The Abramson Cancer Center of the University of Pennsylvania, The Kelly Rooney Foundation seeks to be a catalyst for helping create a generation of women who are breast cancer- free. The Kelly Rooney Foundation marked its 10th year anniversary this summer and celebrates hitting in excess of $1 million in its fundraising efforts, granting $250,000 to Breastcancer.org for education and awareness programs to help young women make healthy lifestyle choices to reduce their risk of getting breast cancer.

The Ambassador of Ireland to the United States

Her Excellency Anne Anderson became Ireland’s first woman Ambassador to the United States in August 2013. Prior to her Washington appointment, she was Ireland’s Permanent Representative to the United Nations in New York. Her previous postings, among others, include: Permanent Representative of Ireland to the United Nations, New York; Ambassador to France (concurrently non-resident Ambassador to Monaco); and Permanent Representative of Ireland to the European Union, Brussels.

About the Irish American Business Chamber & Network, Inc

The Irish American Business Chamber & Network is a nonpartisan business organization dedicated to promoting the interests of its members and the development of economic and educational relationships between the United States and the Island of Ireland. The chamber provides growth opportunities to its members through a series of monthly networking forums, programs and a broad range of services. Its members span the Philadelphia, Delaware and New Jersey tri-state area and include Irish based companies with strong interests in this region

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Almac Group Hosts Official Visit by British Deputy Consul General

admin — Wed, 22 Feb 2017 09:21:23 +0000

Global organisation congratulated for celebrating 20 years in North America

Souderton, P.A., 21^st February 2017 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, was delighted to host an official visit by the British Consulate on Tuesday 21^st February to its state-of-the-art US headquarters in Souderton.

Almac recently marked 20 years in the US and, in November, the Group announced it was investing $25 million to expand its 240,000-square-foot facility in Souderton.

The expansion project involves substantial investment in new machine lines, computer equipment, software and an expanded cold storage area and will create 312 jobs across a wide range of functions and increases capabilities for its Sciences, Clinical Services, Clinical Technologies and Pharma Services businesses.

Ross Allen, Deputy Consul General and US Director of the Department for International Trade was accompanied by John Hoggard, Vice Consul and US Healthcare Sector Lead, at the meeting at Souderton. Mark Weir, Almac’s US Group Financial Controller, presented a comprehensive overview of Almac’s history, global presence, and US operations which was followed by a private tour of the manufacturing facility provided by Rich Segiel, Vice President, Business Development, Almac Clinical Services.

For almost 50 years, Almac, which is headquartered in Craigavon, Northern Ireland, has been delivering the most comprehensive range of integrated drug development services available to the pharmaceutical and biopharmaceutical industry. The Group first established a presence in the US in 1996 with the opening of its clinical trial operations in Audubon, Pennsylvania. By 2000, Almac had expanded its North American presence into North Carolina through the acquisition of Applied Clinical Concepts Inc (ACCI) and Duke Clinical Research Institute Pharmacy (DCRIP) which merged to form Almac Clinical Services based in the Research Triangle Park, Durham.

Mark Weir commented: “We are delighted to have the opportunity to meet with the Vice Consul and Deputy Consul General today and showcase our facility and capabilities, right here in Pennsylvania. Our commitment to the PA State was strengthened in November when we announced a $25 million investment to expand our operations both here and in Lansdale, creating over 300 new jobs, and we very much look forward to continuing our success in the US.”

“I am extremely impressed by the Almac team and their Souderton facility. Almac has a very interesting history and a focused mission” said Ross Allen. “The team are really passionate about their jobs, and rightly so: they are doing some great work that ultimately benefits huge numbers of patients. Almac has found there is an opportunity for their unique services and, in so doing, is bringing jobs and prosperity to both the UK and US.”

By expanding its operations in Europe and North America Almac’s global headcount is expected to reach 5,000 this year. The company is currently seeking exceptional, high-skilled individuals to fill roles at Souderton in areas including IT, business development, quality, production and project management. More information at almacgroup.com/careers/us-careers/

Ends

For further information:

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

About Department of International Trade

The UK’s Department for International Trade (DIT) has overall responsibility for promoting UK trade across the world and attracting foreign investment to the UK. We are a specialised government department with responsibility for negotiating international trade policy, supporting business, as well as delivering an outward-looking trade diplomacy strategy.

To find out how to grow your global business click here.

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Almac Diagnostic Services Appoints Dr Leeona Galligan as Vice President UK Operations

admin — Thu, 16 Feb 2017 12:54:37 +0000

Craigavon, N.I., 16 February 2017

Almac Diagnostic Services, the global personalised medicine company, focusing on the discovery, development and commercialisation of complex diagnostic and companion diagnostic tests, has announced the appointment of Dr. Leeona Galligan (PhD, FRCPath) to the position of Vice President, UK Operations.

In her new role, Dr Galligan will be responsible for all UK based operations including commercial biomarker discovery, CLIA/FDA compliant analytical validation, downstream clinical testing, manufacturing and shipping of clinical specimen and release of controls and reagents for registrational clinical trials. In addition, she will continue to serve as a valuable member of the Almac Diagnostic Services’ Executive team helping to define and implement its global business strategy.

Leeona joined Almac Diagnostic Services in September 2009 as a Senior Scientist within its research and development department. In 2012, she was appointed Manager of the newly formed clinical testing laboratory and, in 2014, was subsequently promoted to Head of UK laboratory based Operations.

Leeona obtained a B.Sc (Hons) in Genetics and a M.Med.Sc. (Laboratory Science) from Queen’s University Belfast and received her PhD in molecular haematology from Trinity College Dublin in 2003. Her research focused on the isolation and characterisation of a novel cellular receptor that is targeted in the treatment of sepsis. She subsequently completed a postdoctoral fellowship on the molecular mechanisms of drug resistance in colorectal cancer at the Department of Oncology at Queen’s University Belfast.

Following her Postdoctoral Fellowship, Leeona completed a 4 year training programme in specialist haemato-oncology laboratory services leading to her registration with the UK Health and Care Professions Council as a Clinical Scientist. She has also been awarded Fellowship of the Royal College of Pathologists (FRCPath) through examination in haemato-oncology and laboratory management.

“Leeona’s appointment to VP UK Operations is in recognition of the significant contribution she has made to our business over the past eight years,” said Paul Harkin, Managing Director & President, Almac Diagnostic Services.

“Her wealth of experience and expertise in the personalised medicine arena is a valuable asset which will help strengthen and deepen our Management team. We look forward to working together to further develop our strategy and continue to offer our global clients an expanded array of services.”

Ends

Notes to editors

About Almac Diagnostic Services

Almac Diagnostic Services is a global personalised medicine company, focusing on the discovery, development and commercialisation of complex diagnostic and companion diagnostic tests.

Our global, state of the art, CLIA-accredited labs in the USA and Europe are ready to operate both research-use-only and clinical diagnostic assays. Our flexible approach allows Almac Diagnostic Services to be platform agile and to provide genuinely novel Diagnostic and CDx solutions for even the most challenging of Pharma and BioTech clients.

About Almac Group
‘Partnering to Advance Human Health’

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Almac Group Launches Next Generation Temperature Management Software

admin — Mon, 30 Jan 2017 14:06:33 +0000

Almac Group Launches Next Generation Temperature Management Software

Innovative ‘TempEZ™’ Solution Offers Unrivalled End-to-End Drug Product Visibility

Craigavon, N.I., 30 January 2017 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has launched TempEZ™ – a ground-breaking temperature management software – and the inaugural offering from Almac’s “Next Generation Temperature Management Portfolio”. TempEZ is a web-based platform providing clients with a single database to store temperature data and to ensure regulatory compliance, thereby safeguarding the quality and integrity of drug product.

The superior, Good Distribution Practice (GDP) compliant solution has been designed by Almac’s global in-house temperature management experts who have over 25 years’ experience in the field. Their deep insight into the challenges faced by their clients has enabled TempEZ to be shaped to provide the most flexible, convenient and secure platform available on the market. This offering guarantees complete visibility of any commercial or clinical drug product’s temperature compliance throughout its entire journey from manufacture to patient administration, and crucially, not just transit.

The TempEZ design enables the client to use any monitor and any logistics provider for managing transportation of their product to its final destination. The GMP compliant software provides readily accessible data throughout the entire supply chain building a complete temperature history for a product at both a lot and serialised level.

By leveraging Almac’s extensive experience with medical products and as a logistics provider, clients can also benefit from the additional supporting Temperature Management services offered to supplement their own internal efforts. Almac’s global Temperature Management team perform compliance, excursion adjudication and life cycle management services. In addition, their Temperature experts will interpret the data collected by TempEZ and assist clients to develop bespoke solutions to improve their internal business processes and vendor performance.

“Almac’s TempEZ is the only software platform available on the market that offers clients a tailored, fully adaptable and GDP compliant solution providing a complete, end-to-end temperature history of their drug product.” explains Donna Christopher, Global Vice President Operations, Almac Clinical Services “In the current data model clients have difficulty accessing and analysing data to determine the impact of individual excursions occurring throughout the life cycle on the overall integrity of the product. By design, TempEZ gives any stakeholder in your supply chain the ability to upload data, resulting in a single repository of your temperature data. This makes the data readily accessible and any analysis easy to complete. I am delighted to announce the launch of TempEZ, which not only offers convenience for our clients but, more importantly, provides a single platform to document that a product has stayed within it labelled specification throughout its life cycle, helping you to protect the safety of your patient.”

Almac’s Supply Chain Solutions Manager, Heather Bogle, will be demonstrating TempEZ at IQPC’s 16th Annual Cool Chain Temperature Controlled Logistics Europe event (30 Jan – 2 Feb). To find out more please visit: https://www.almacgroup.com/journey

-Ends-

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Launches Next Generation Temperature Management Software appeared first on Almac.

Almac Group Announces Further Global Expansion as it Secures New Premises in Republic of Ireland

admin — Thu, 26 Jan 2017 09:22:20 +0000

Craigavon based global contract pharmaceutical development and manufacturing organisation, Almac Group, has secured new premises in Dundalk, County Louth to support its ongoing global expansion plans in response to increased client demand.

Almac will make a £ multimillion investment in the new facility at IDA Business Park. The expansion has been supported by the Department of Jobs, Enterprise and Innovation through IDA Ireland, Ireland’s inward investment promotion agency.

The facility will be utilised by Almac Pharma Services and Almac Clinical Services, both of which are registered to operate in the Republic of Ireland. The new premises increases the Group’s European footprint by 32,000sq ft and provides continued presence within the European Union in the long term.

This investment comes just weeks after Almac confirmed ambitious plans to expand its operations at its global Headquarters in Northern Ireland with the construction of a new laboratory and additional office facilities. The company simultaneously announced investment at its North American site creating an additional 300 new, full time jobs. These investments will see an increase of Almac’s global headcount to over 5,000 by the end of 2017.

Alan Armstrong, CEO Almac Group commented: “This latest investment in Dundalk is a further example of Almac’s ambitious global expansion plans and will deliver up to an additional 100 new jobs within the first two years. This news comes in addition to our recent announcement of a £27m investment at our global Headquarter site in Craigavon, our US operations and our European facility in Athlone. All of this is evidence of Almac’s commitment to provide best-in-class products and services to our clients across the world and we would like to thank all those who have supported us to date.”

Welcoming the investment by Almac, Minister for Jobs, Enterprise and Innovation, Mary Mitchell O’Connor said: “This is a very exciting project for Dundalk and builds on the strong cluster of multinational companies who have very successfully located in that town in recent years and who have found it a great base from which to promote their sales into other EU Member States. Ireland’s expertise in the Pharma sector is unrivalled, with virtually all the major international players having operations here, thus generating synergies and opportunities for new companies investing with us. These additional 100 jobs to be provided are very welcome and we look forward to a long and mutually beneficial engagement with Almac into the future”.

Martin Shanahan, CEO, IDA Ireland said “Almac’s decision to expand into Dundalk provides the company with certainty of access to the European Union in the long term– this certainty of access is an increasingly important selling point for Ireland as we look to win business for Ireland. IDA Ireland will continue to promote Ireland as an ideal location for companies from a range of sectors including pharmaceuticals, IT and financial services that are looking to ensure that they have a presence in the European single market.”

This investment strengthens Almac’s existing presence in the Republic of Ireland following the acquisition of Arran Chemical Company facility in Athlone in 2015. The facility has expanded the company’s biocatalysis services, which is part of Almac’s Sciences Business Unit.

Ends

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Announces Further Global Expansion as it Secures New Premises in Republic of Ireland appeared first on Almac.

Almac Group Executive to Speak at IQPC Clinical Trial Supply Europe 2017

admin — Thu, 12 Jan 2017 15:28:56 +0000

Supply Chain Solutions Manager Shares Expertise on the Regulatory Impacts of Temperature Management

Craigavon, N.I., 12 January 2017 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced that Heather Bogle, Supply Chain Solutions Manager, Almac Clinical Services, will speak at this years’ Clinical Trial Supply Europe conference, being held in London from 23 January until 25 January.

Ms Bogle’s presentation, entitled “Regulatory Impact: Technology, Tools, and Insight to Mitigate Risk”, will take place on day two (24^th January) of the conference where she will share the platform with a growing list of industry experts from across the globe.

During her talk, Heather will share her expertise and in-depth knowledge on a range of key considerations regarding understanding the challenges of staying compliant in the realm of Temperature Management and will discuss case studies on how processes, technology and tools are implemented. In addition, Heather will also be examining global case studies on how to reduce errors, improve efficiencies and develop compliance.

Heather Bogle graduated from Queens University, Belfast with a BSc in Chemistry. She joined Almac in 2001 and has worked with a wide range of Pharma and Biotech companies, from small specialist providers to multinationals, to manage supply chains across the full range of sponsors and trial designs. Heather has first-hand experience in managing the supply chain for studies across the globe with temperature sensitive products. She has expert knowledge on the challenges with temperature management through the supply chain and extensive experience in developing creative, efficient and robust solutions.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Executive to Speak at IQPC Clinical Trial Supply Europe 2017 appeared first on Almac.

Almac Group Collaborates with Exostar to Extend Clinical Trials Identity Management

admin — Thu, 15 Dec 2016 14:19:41 +0000

eClinical Application Users Benefit from Single Sign-On Expediency & Enhanced Security

Souderton, PA., 15 December 2016 – Almac Clinical Technologies, part of the Almac Group, the world’s largest privately-held contract pharmaceutical development and manufacturing organisation, today announced a collaboration with Exostar, whose cloud-based solutions help companies in highly-regulated industries mitigate risk and solve their identity and access challenges. The companies are working together to provide Single Sign-On (SSO) and Federated-Authentication access to eClinical applications used to support clinical trials, including Interactive Response Technology (IRT).

In its first eClinical proof-of-concept collaboration with Exostar, Almac successfully integrated its market-leading IXRS ^® 3 IRT with Exostar’s identity and access management platform for life sciences. As a result, Almac’s global client base is set to benefit substantially through simplified credential management for both clinical sites and trial sponsors – ultimately helping to streamline clinical trial workflows. The SSO functionality eliminates the need for site personnel and patients to maintain multiple credentials. When combined with fast credential de-provisioning, the solution enhances the controls and security surrounding trial-sponsor intellectual property. The user-authentication functionality extends to other federated partners of Exostar, including TransCelerate, Merck and AstraZeneca, further augmenting the value of the platform.

“The clinical trials process is dynamic and complex. With IXRS^® 3, Almac expedites drug discovery by bringing constituents, materials, and data together so the right people have access to the right information and supplies at the right time,” said Kenny Kong, Exostar’s Director of Life Sciences and Health IT. “By federating to the Exostar platform, Almac is furthering the value of their solution by enabling SSO for their clinical application, which eases the access burden on study sponsors, improves the site user experience, and raises the level of security.”

Charlie Morris, VP, New Products & Services – Almac Clinical Technologies commented:

“Protecting sensitive data and securely conducting clinical trial operations are critical functions, yet can prove immensely challenging for sponsors. Exostar’s cloud-based platform provides a perfect solution to enable our clients to overcome these challenges. We’re excited about Exostar’s dedication to streamlining identity management in the highly-regulated industry we work in, and we firmly believe that combining best-in-class technology solutions like IXRS® 3 with Exostar’s identity and access management platform for life sciences will inherently unlock new value and reduce burden for the biopharmaceutical clients we serve.”

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com

About Exostar
‘Providing a Trusted Workspace for Secure Business Collaboration’

Exostar, named a Cool Vendor for 2016 by Gartner, offers cloud-based solutions that help companies in highly-regulated industries mitigate risk and solve identity and access challenges. Nearly 125,000 organizations leverage Exostar to help them collaborate securely, efficiently, and compliantly with their partners and suppliers. By offering connect-once, single sign-on access, Exostar strengthens security, reduces expenditures, and raises productivity so customers can better meet contractual, regulatory, and time-to-market objectives. www.exostar.com.

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Almac Group Appoints Professor Tom Moody as VP of Technology Development and Commercialisation

admin — Tue, 13 Dec 2016 15:07:35 +0000

Craigavon, N.I., 12 December 2016 – Almac Group, the global contract development and manufacturing organisation has announced the appointment of Professor Tom Moody to the position of VP Technology Development and Commercialisation within Almac Sciences, effective from 1 December 2016.

Tom joined Almac in October 2001, moved into management in 2008 and has held the position of Senior Manager for the last 4 years operating in his role as Head of Biocatalysis and Isotope Chemistry. Over this time he has led the development of Almac Sciences’ Biocatalysis Technology platform which has seen rapid growth and has multiple applications across a range of project scales and industry sectors.

In the last year he has played an integral role in the integration of Arran Chemical Company Ltd into Almac Sciences and ensured smooth transfer of Biocatalysis manufacturing projects from Craigavon to the Arran site in Athlone, Ireland.

In his new role, Tom will be responsible for the development and application of platform technologies within both the Sciences and Arran businesses, in addition to supporting and directing commercialisation of new technology. He will have direct operational responsibility for the Biocatalysis and Isotope Chemistry businesses and the R&D function within Arran.

Tom will report directly to Dr Stephen Barr, President & MD, Almac Sciences who congratulated him on his promotion:

“Tom’s considerable expertise and experience within biocatalysis and chemical synthesis has been crucial in developing the Sciences, and more recently, Arran businesses. In addition, his ability to form incredibly strong relationships with our clients has been critical to the growth and success of these particular service offerings. I am delighted to announce Tom’s promotion to VP and wish him every success in his new role.”

Tom holds a Masters in Business with Distinction in Business Strategy, a PhD in Organic Chemistry and a Bachelor of Science (BSc) in Chemistry (First Class Hons).

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com

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Almac Group Trio are Masters of Work and Study

admin — Mon, 12 Dec 2016 11:47:54 +0000

Craigavon, N.I., 12^th December 2016 – Almac Group, the global contract development and manufacturing organisation, is honoured to support three of its employees through a new, tailored MSc Pharmaceutical Analysis degree undertaken at Queen’s University Belfast.

The Almac Sciences’ employees, Alison Quinn (Analytical Chemist), Robert Elliott (Data & Document Reviewer) and Laura McGee (Chemist) graduated together during a ceremony held at QUB on Friday 9^th December.

In an effort to encourage young people and students to continue their study of science, in particular, chemistry, Almac contributed vital input into the MSc curriculum and helped shape its programmes. Employees across Almac Sciences were invited to express interest in undertaking a two-year, part-time course and the three who put their names forward were funded by the organisation and went on to pass the intensive programme.

During their studies Laura, Robert and Alison continued to work four days a week at Almac’s global Headquarters in Craigavon, where they used their enhanced understanding of theoretical analytical techniques taken from the degree programme to better develop and troubleshoot analytical methods for Almac’s clients. Almac benefited greatly from the increased knowledge and applied learning introduced to the business whilst enabling the Graduates to progress and develop their own career from within.

Considering the success of this years’ graduates and the positive impact on both an individual and business level, Almac will continue to fund and support employees through this Pharmaceutical Analysis Master’s Degree for the foreseeable future. Two more employees have already enrolled in this year’s course and this number is expected to grow in the future as more new graduates are recruited into the business.

Stephen Barr, President & MD, Almac Sciences commented: “This is a unique opportunity for our employees to be part of something new which will enable them to develop their career whilst bringing insight and new techniques to our business. We are also proud to support other initiatives which drive interest in science and encourage young people to become equipped with the skills and qualifications needed by world leading life sciences companies such as Almac.”

Almac founder Sir Allen McClay, who died in 2010, was a long-time supporter of Queen’s University. He was the founding Chair of the Queen’s University of Belfast Foundation and one of the largest benefactors to Queen’s in the University’s history. The McClay Research Centre for Pharmaceutical Sciences in the School of Pharmacy, which bears his name, was funded by The McClay Trust, a charitable body which he established.

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com

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Almac Group Announces Strategic Partnership with inVentiv Health

admin — Tue, 06 Dec 2016 14:05:34 +0000

Offers Clients Advanced, Best-in-Class eClinical Technology Solutions

Souderton, PA., 6 December 2016 – Almac Clinical Technologies, part of the Almac Group, the world’s largest privately-held contract pharmaceutical development and manufacturing organisation, today announced the formation of a strategic partnership with inVentiv Health, a leading biopharma outsourcing company combining a leading CRO and the industry’s only Contract Commercial Organisation (CCO). The partnership presents an opportunity for both organisations to provide clients and sites with streamlined access to best-in-class clinical trial Interactive Response Technology (IRT) solutions.

Through the strategic partnership, Almac Clinical Technologies will now provide IRT solutions to inVentiv clients, including its market-leading IXRS^® technology. This technology has been used in over 2,000 trials and provides sponsors with the visibility and control needed to make data-driven decisions. inVentiv Health’s IRT specialists will also join Almac Clinical Technologies’ 500+ person expert consultancy team. This team and technology transition will allow Almac and inVentiv to seamlessly service current inVentiv Health IRT clients.

Gregory Skalicky, Chief Commercial Officer, inVentiv Health Clinical Division commented:

“We’re committed to accelerating clinical trials and see tremendous value in applying leading technology solutions to streamline the process. This partnership will enable inVentiv Health to enhance its clinical services continuum by offering clients access to Almac’s comprehensive, best-in-class IRT services to unlock further efficiencies in trial study configuration and deployment.”

inVentiv Health selected Almac as a partner based on Almac’s dedication to customer focus, quality, expertise and innovation. These factors align with inVentiv Health’s commitment to accelerating client success.

Valarie Higgins, President & Managing Director, Almac Clinical Technologies commented:

“This partnership reaffirms Almac’s position as the global leader in clinical technology solutions, like IRT. We’re thrilled to partner with inVentiv Health as their organisational mission aligns seamlessly with the ethos and priorities of the Almac Group. We look forward to our exciting new venture together and the opportunity to offer clients an expanded array of choices to help support the critical work they do every day.”

Almac Clinical Technologies and inVentiv Health will be exhibiting at the 8^th annual SCOPE Summit for Clinical Operations Executives on 24-26 of January 2017. Representatives from both organisations will be available to discuss the partnership in greater detail.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com

About inVentiv Health

inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions designed to improve client performance. With approximately 15,000 employees and the ability to support clients in 90 countries, our global scale and deep therapeutic expertise enable inVentiv Health to help clients navigate an increasingly complex environment. For more information, visit inVentivHealth.com.

For information about Almac and this Press Release, please contact Matt Cocking at 1.215.660.8500

For information about inVentiv Health and this Press Release, please contact Danielle DeForge 1.781.425.4624.

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Almac Group Executive to Speak at CTS East Asia Conference

admin — Mon, 28 Nov 2016 13:59:37 +0000

Global VP Quality Shares Expertise on Managing Biosimilar Products through Supply Chain

Craigavon, N.I., 28th November 2016 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced that Paul O’Connor, Global VP Quality, Clinical Services, will speak at this years’ Clinical Trial Supply, East Asia conference, being held in Seoul, Korea from 30 November to 1 December.Mr. O’Connor’s presentation, entitled “Successfully managing Biosimilar products through the Clinical Supply Chain”, will take place at 14:00 on day one of the conference where he will share the platform with a growing list of industry experts from across the globe.During his talk, Paul will share his expertise and in-depth knowledge on a range of key considerations regarding biosimilars highlighting how their handling should be considered differently to other products. He will also review considerations for acquiring comparator compounds and packaging, labelling and release of these products. Paul also examines best practices for maintaining temperature control during transit and examines new shipping and monitoring solutions, alongside Supply Chain Management strategies that can be deployed to reduce overall cost and minimise product waste.

Paul has almost 25 years’ experience in the industry and is responsible for the global oversight of quality operations, procedures and processes throughout the Clinical Services business encompassing over 220 professional employees based in US, UK and Asia. In addition, he continues to act as a European Union Qualified Person (QP) for the organisation, a post held by him for over 15 years. He holds a BSc First in Biochemical Sciences from Ulster University and is a renowned author of multiple published articles relating to quality matters.

Almac Clinical Services continue to serve the global Pharma and Biotechnology industries and have a significant presence within the APAC market, helping inform and shape the clinical trial infrastructure across all key clinical trial destinations.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Executive to Speak at CTS East Asia Conference appeared first on Almac.

Almac Group Team Up with Irish American Business Chamber & Network for Life Sciences Forum

admin — Thu, 17 Nov 2016 10:51:45 +0000

Souderton, PA, USA – November 17^th, 2016 – The Irish American Business Chamber and Network (IABCN) has teamed up with their 2016 Ambassador Award honouree, Almac Group, the global contract development and manufacturing organisation, to host a life sciences forum. The event is an interactive symposium featuring pharmaceutical/life sciences and commercial industry experts who will come together to discuss major trends in drug development, the cost of healthcare and impact on patients and our economy. The intent of the forum, scheduled for November 17^th, 2016 at 1pm, is to explore big pharma’s role in shaping patient wellness and our economy. Almac is sponsoring the forum and will host the event at its North American Headquarters in Souderton, PA. Other sponsors include KYW Newsradio and PixarBio.

Panellists for the event include Brendan Fenton, Regional Finance Director for Australia, Canada and Western Europe for Bristol-Myers Squibb, John Barry, Head of Portfolio Sourcing and Relationship Management, Merck Research Laboratories at Merck & Co., and Michael Sapienza, Chief Executive Officer of The Colon Cancer Alliance. The panel will be moderated by George Tiger, Vice President Global Business Development, Almac Clinical Technologies. The discussion will span dynamic industry topics including the greatest challenges faced today and the next generation of future collaborations that will be needed, the impact of the pharmaceutical industry in the broader economy, the pharmaceutical business model and risk profile and patient advocacy and engagement.

George commented: “We are delighted to be working with the British American Business Council and the Irish American Business Chamber and Network of Philadelphia on this initiative. It is a fantastic opportunity to share knowledge and discuss the pertinent topics relating to our industry – in addition to sharing a platform with experts and key opinion leaders from across the pharmaceutical spectrum.”

The Irish American Business Chamber & Network, Inc. (IABCN) is a nonpartisan business organisation promoting the interests of its members and the development of economic and educational relationships between the United States and the Isle of Ireland.

For more information, visit iabcn.org or email abarry@iabcn.org.

About Almac Group
‘Partnering to Advance Human Health’

The international company is a privately owned organization that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information visit – almacgroup.com or e-mail media@almacgroup.com.

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Almac Group Expands Commercial Capabilities to Meet Industry Demand for Paediatric Formulations

admin — Mon, 14 Nov 2016 13:56:08 +0000

Craigavon, N.I., UK, – Date 14 November 2016 – Almac Group, the global contract development and manufacturing organisation, is pleased to announce that it has expanded its MHRA/FDA approved UK commercial packaging facility with the acquisition of a stick sachet packaging line from Merz.

The acquisition comes in response to growing demand for the specialist packaging solutions for paediatric drug products, specifically powders, minitabs or granules into stickpack sachets. This investment was made in partnership with a long-term commercial US client who having worked with Almac since 2010, now sought an integrated commercial manufacturing and packaging solution for the EU supply of their new paediatric formulation drug product.

In line with EU Paediatric Regulations (EC1901/2006 and EC1902/2006), the US client implemented its Paediatric Investigation Plan (PIP) and developed and launched an age appropriate formulation to meet infant patient needs; with Almac manufacturing the paediatric granules, primary packing into stickpack sachets and then into wallet cards.

To facilitate the packaging of paediatric dosage forms, investment was made in Merz Stickpack technology. The SBL-50 stickpack technology is a fully automated forming, filling and sealing machine capable of filling 80 stickpacks / minute. This flexible technology not only meets the stickpack presentation needs of Almac’s current clients but has capacity to process new paediatric drug products (powders, granules and minitabs) that require this specialist packaging.

David Downey, VP Commercial Operations at Almac commented “Almac continue to expand our commercial packaging capabilities and the addition of this stickpack solution strengthens Almac’s position in providing flexible services to meet various market needs from small volume orphan drug products to large scale marketed products in both adult and paediatric forms.”

Holger Merz, General Manager at Merz said: “The innovative and committed team at Almac set up a compact, highly flexible packaging solution for micro tablets and powders in stickpacks to service the growing demand for this user-friendly dosage form. Advanced primary packaging forms like stickpacks offer highest flexibility for diversification of pharmaceutical products.”

About Almac’s Commercial Services

With over 40 years’ experience and commercial facilities in the UK and US, our global reach and local expertise provides flexible, quality led commercial solutions.

Providing commercial services for new product launches or transferring existing commercial products, we specialise in the scalable manufacture and packaging of solid oral dosage forms from niche orphan drugs to high volume marketed products. Complimented by tailored packaging solutions for sterile, sachet and blister presentations we have supported the launch of multiple orphan drug products over the last 3 years. Value added solutions in artwork/pack design, QP release and 3rd Party Logistics provides end-to-end commercial solutions for our client partners.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information visit almacgroup.com or e-mail media@almacgroup.com.

About Merz

For more than 40 years, the company MERZ Verpackungsmaschinen GmbH has been developing and manufacturing stickpack-machines, 3-and 4-side sealing bag machines, innovative dosing technology as well as tailored packaging equipment. MERZ packaging machines are in use in more than 40 countries all over the world!

A significant advantage for our customers is the supply of complete “turn-key” lines with 1 to 5 lanes, including end of the line packaging into folded cartons or into cardboard boxes.

The family owned company is the place for personal, customized packaging solutions and special machineries.

For more information, please visit www.merz-system.de or e-mail to mail@merz-system.de

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Almac Group Announce £27 million Global Expansion

admin — Thu, 10 Nov 2016 16:27:48 +0000

Almac Group Announce £27 million Global Expansion

Global Headcount Set to Reach 5,000 by 2017

Craigavon, N.I., 10^th November 2016 – Almac Group, the global contract pharmaceutical development and manufacturing organisation is excited to announce ambitious plans to expand its operations in Europe and North America increasing its global headcount to reach 5,000 by 2017.

As part of its ongoing global growth strategy and in response to increased client demand for its range of services the organisation will invest a further £20 million at Almac’s US headquarter site in Souderton, Pennsylvania to expand its existing 240,000-square-foot facility in addition to leasing a 26,000-square-foot office space in nearby Lansdale.

The expansion project will create 312 new, full time jobs across a wide range of functions and increases capabilities for its Sciences, Clinical Services, Clinical Technologies and Pharma Services businesses. The company received a funding proposal from the Department of Community and Economic Development comprised of a £1.3 million Pennsylvania First Program grant and involves substantial investment in new machine lines, computer equipment, software and an expanded cold storage area.

The company is also investing in the region of £5 million to build an additional laboratory and office facility at its global headquarters site in Craigavon, Northern Ireland. Around 170 existing employees will be transferred to the new building, many of whom are chemists and analysts involved in supporting drug research, development and manufacture.

An additional £2 million is being invested in the development of the Arran Chemical Company facility in Athlone, Ireland which was acquired by Almac last year. The capital project is enabling an upgrade of the existing site infrastructure and brings additional manufacturing capacity and assets on stream as well as more distillation and drying capabilities. Together, the expansion plans facilitates significant growth of the Almac Sciences business, which is vital to meet ongoing demand for its innovative API and chemical development services, with global headcount within this Business Unit alone expected to reach over 500 by next year – more than double its figure just three years ago.

In total, the Almac Group employs over 4,600 staff globally and is set to reach 5,000 by the end of 2017.

Secretary Dennis M. Davin from the Pennsylvanian Department of Community and Economic Development announced Almac’s plans during a visit to its North American Headquarter facility on Thursday 10^th November. This announcement comes just weeks after the company announced a £4.2 million expansion at its facility in North Carolina.

Governor of Pennsylvania, Tom Wolf welcomed the news: “In 2007, Almac Group invested $100 million, retained 495 jobs, and created another 264 jobs, when it successfully established its U.S. headquarters in Pennsylvania,” said Governor Wolf. “Since then, we’ve seen Almac Group’s significant contributions to the economic vitality of the region as a major player in south-eastern Pennsylvania’s strong bio-pharma industry, and we look forward to its continued success as it once again chooses Pennsylvania for its operations expansion.”

Alan Armstrong, CEO Almac Group commented “Due to significant industry demand for our services it is essential we build capacity and increase headcount to ensure we continue to compete at a global level. This year we are celebrating our twentieth year in the US and we are excited to make a further commitment within the Pennsylvania State and throughout North America. We are also delighted to announce our further expansion plans across Europe as we continue to build upon our tremendous global success and we are looking forward to an exciting future.”

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

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Almac Group Appoints Dr. Victor Diaz Perez as Head of Physical Sciences

admin — Fri, 28 Oct 2016 09:20:24 +0000

Craigavon, N.I., 26th October 2016 – Almac Group, the global contract development and manufacturing organisation has announced the appointment of Dr. Victor Diaz Perez as Head of Physical Sciences.

Dr. Diaz will further complement the existing physical sciences team bringing considerable experience in research and development within solid state chemistry. He will be responsible for Almac’s Solid State Chemistry and Physical Sciences business and tasked with strengthening the overarching chemical development strategy.

Before joining Almac Dr. Diaz spent ten years with Pharmorphix®, now part of Johnson Matthey Plc., a global CRO providing solid state services for the pharmaceutical and fine chemicals industry. There he worked as Projects Director before being appointed as Site Manager / Operations Director. He was also a key player in the acquisition of Pharmorphix® by Johnson Matthey Plc. from Sigma Aldrich Co. Ltd, which completed in October 2015.

Before joining Pharmorphix®, Dr. Diaz worked for over seven years as a Medicinal Chemist at Medivir AB, both within the hit identification and lead optimisation teams and, prior to that, he worked at High Force Research, Ltd providing chemical synthesis and R&D service to the pharmaceutical, agrochemical and fine chemical industries.

John Robson, VP Quality Operations at Almac Sciences commented on Dr. Diaz’s appointment: “Victor’s combined experience within physical sciences and his extensive knowledge of strategic management makes him a valuable addition to our team. We are delighted he has accepted this role with Almac and we look forward to working together to continue to develop our global business and provide best in class, innovative drug development solutions to our growing client base.”

Victor has a Ph.D. in Organic Chemistry from the University of Seville working on the design, synthesis and evaluation of glycomimetics of natural occurring azasugars used for the inhibition of glycosidases. He has also been awarded CChem status and recognition as a Fellow of the Royal Society of Chemistry.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com

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Almac Group’s Temperature Management Software Solution Receives Innovation Award

admin — Tue, 18 Oct 2016 13:03:09 +0000

Craigavon, N.I., 18th October 2016 – Almac Group, the global contract development and manufacturing organisation is delighted to announce that its temperature management software solution, TempEZ™, has received the award for Innovation from IT services company, Version 1, during their ‘Evolving the Digital Enterprise Expo’ at the Royal College of Physicians, Dublin, Ireland.

Judges selected the TempEZ™ offering based on three key criteria – excellence and innovation in delivery of Almac’s temperature management solution; the scale and complexity of the environment in which the project was executed and the tangible evidence of enhancing Almac’s business. The coveted award was accepted by Julie Shannon, Almac Group’s IS Support Manager during the event. Almac’s TempEZ™ solution was showcased at the 14th IQPC Cold Chain GDP & Temperature Management Logistics Global Forum in Boston on 26th September 2016. The innovative service offers clients a single database to store temperature data from manufacture of product right through to patient administration and assists with GDP and GMP regulatory compliance. The platform provides clients with the ability to record planned and unplanned excursions for pharmaceutical products and build a complete temperature history at either a batch or serialised level. The system is monitor, logistics provider and Interactive Response Technology (IRT) vendor agnostic, allowing clients flexibility in managing their supply chain. Donna Christopher, Global VP of Operations, Almac Clinical Services expressed her delight with the award stating:

This is worthy recognition of a market leading temperature management solution and also the years of work that our team has dedicated to developing this innovative product for our customers. We developed TempEZ™ from a pharmaceutical perspective, directly leveraging our experience of packaging, storing and distributing medical products; 2.5 million shipments over the last decade alone. We are confident that the launch of this software marks a turning point in the management of global temperature controlled logistics.

About Almac Group

‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

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Almac Group Wins Prestigious Research and Development Award

admin — Fri, 14 Oct 2016 06:57:35 +0000

Craigavon, N.I., 14 October 2016 – Almac Group, the global contract development and manufacturing organisation is delighted to have won the coveted Research and Development achievement award at this years’ Pharma Industry Awards.

The annual event aims to recognise and celebrate the most original and innovative individuals and companies that demonstrate excellence within the Irish Pharma sector and the glittering awards ceremony took place in the Ballsbridge Hotel, Dublin on the evening of Thursday 13^th October.

Almac received the award for demonstrating its excellence in enzyme technology development through their “selectAZyme™” research program. This is achieved through the unique collaboration between the biocatalysis team within Almac’s Sciences business unit and Arran Chemical Company which was acquired by the Almac Group in November 2015. The “selectAZyme™” program is centred around Almac’s enzyme platform which delivers a diverse A-Z range of enzymes for development and scale-up within medicinal chemistry, metabolite synthesis and specialty chemicals for large scale manufacturing projects.

An independent panel of recognised and expert individuals within the pharmaceutical sector judged the entries and determined the winners based on a number of key attributes. Almac beat off stiff competition and clearly demonstrated its team integration, innovation, increased business performance, skills benefit to the Northern Irish and Irish economies plus the environmental benefits associated with biocatalysis technology to pick up the prestigious trophy.

Professor Tom Moody, Head of Biocatalysis and Isotope Chemistry at Almac & Head of Technology at Arran Chemical Company commented “This award further demonstrates the combined capability, expertise and experience of the Almac and Arran Chemical Company teams. We are delighted to be recognised at the Pharma Industry Awards and pride ourselves on our ability to provide high quality, flexible and innovative solutions to meet our global clients’ requirements.”

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com

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Almac Group Discover an Exciting Link between its Immune Response Assay and Checkpoint Inhibitor Based Therapy

admin — Mon, 10 Oct 2016 16:02:25 +0000

Study Published in JNCI

Craigavon, N.I., 10 October 2016 – Almac Group’s Diagnostic Services business unit today announced the identification of a novel immune response mechanism in breast tumours deficient in DNA repair. The study has been published in the Journal of the National Cancer Institute (JNCI).

The publication entitled ‘Activation of STING-Dependent Innate Immune Signalling By S-Phase-Specific DNA Damage in Breast Cancer’ follows on from Almac’s previous publication of a 44 gene immune based assay capable of prospectively identifying breast cancer patients with a defect in the FA/BRCA pathway who benefit from anthracycline based chemotherapy.

The current study explains the molecular basis of this 44-gene immune based assay and demonstrates that the genes in the assay reflect activation of the innate immune response cGAS/STING/TBK1/IRF3 pathway in response to DNA damage.

The study is particularly interesting because it provides a clear rationale for the observed link between DNA repair deficiency and activation of the immune checkpoint PD-L1. Almac will now pursue their 44-gene assay as a means of prospectively identifying breast cancer patients likely to respond to PD-L1 targeted therapies.

The study was performed in collaboration with Queens University Belfast. Dr Eileen Parkes, Academic Clinical Lecturer at the Centre for Cancer Research and Cell Biology at Queen’s University said: “This research provides a new way of explaining how immune cells are targeted to certain breast tumours, and could help decide which patients are most likely to respond to this new class of immune therapies. Approximately one third of breast cancers will have this immune-rich picture, therefore a huge amount of patients could benefit from this research.”

Professor Richard Kennedy, MD, PhD, McClay Professor in Medical Oncology, Queens University Belfast and VP and Medical Director, Almac Diagnostic Services commented “The study provides strong justification for the underlying biology that causes enhanced PD-L1 expression. Almac will now engage with pharma and academia to investigate the potential clinical benefit for predicting response to immune checkpoint inhibitors, such as PD-L1 and IDO1 and their use in combination with DNA damaging agents”.

About Almac Diagnostic Services

Almac Diagnostic Services is one of five business units operating under the ownership of the Almac Group. The global personalised medicine company is focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics. In addition, Almac Diagnostic Services has a pipeline of proprietary oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com/diagnostics/

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Almac Diagnostic Services Partner with ArcherDX

admin — Tue, 04 Oct 2016 15:04:18 +0000

Technology Offering Expanded to Include FusionPlex® and VariantPlex NGS Assays

Craigavon, N.I., UK & Boulder, CO – 04 October 2016 Almac Group’s Diagnostic Services business unit today announced its partnership with ArcherDx to provide FusionPlex® and VariantPlex NGS assays as part of their CDx partnership solutions.

ArcherDX, the leader in NGS-based fusion detection assays and software, has also approved Almac Diagnostic Services as a Certified Service Provider (CSP) of Archer® NGS assays. This agreement further establishes Almac Diagnostic Services as a trusted partner providing scientific and technological excellence globally.

Almac Diagnostic Services, the personalised medicine business unit of the Almac Group partners with Biopharma on the discovery, development and commercialisation of diagnostic tests including companion diagnostics. It also has an internal portfolio of both prognostic and predictive assays in development across a wide range of disease areas.

As an Archer Certified Service Provider, Almac Diagnostic Services will leverage their CLIA-certified lab to include Archer FusionPlex® and VariantPlex™ assays in their service offering. About becoming an Archer CSP, Michael Sloan, VP Commercial Operations at Almac Diagnostic Services, stated, “Archer assays will not only enable us to offer targeted sequencing panels across a wide range of malignancies, but they give us the ability to customise gene panels based on our partners’ needs.”

Jason Myers, PhD, CEO at ArcherDX, added “Almac Diagnostic Services has a strong support network as part of the Almac Group, which gives them the ability to provide clinical services beyond the UK. Because clinical development is a global need, we’re excited that Almac Diagnostic Services can offer ArcherDX NGS assays for international drug and CDx development and clinical support.”

About ArcherDX

ArcherDX addresses the bottlenecks associated with using NGS in translational research by offering a robust platform for targeted sequencing applications.

By combining proprietary Anchored Multiplexed PCR (AMP™) chemistry and easy-to-use, lyophilized reagents, Archer NGS assays generate highly enriched sequencing libraries to detect gene fusions, point mutations, CNVs and RNA abundance. Complemented by the Archer suite of bioinformatics software, ArcherDX technology dramatically enhances complex mutation identification and discovery.

ArcherDX is headquartered in Boulder, Colorado, USA.

http://archerdx.com

About Almac Diagnostic Services

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com/diagnostics/

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Almac Group Celebrates 20 Years in North America with $5.2 million Expansion Creation of 79 Additional Jobs in North Carolina

admin — Tue, 20 Sep 2016 17:05:16 +0000

Craigavon, N.I., UK, – Tuesday 20 September 2016 Almac Group, the global contract development and manufacturing organisation, is celebrating 20 years in North America by announcing a $5.2 million investment and the creation of almost 80 new jobs across its Durham, North Carolina facilities.

Almac first established presence in the US in 1996 with the opening of its clinical trial operations in Audubon, Pennsylvania. By 2000, Almac had expanded its North American presence into North Carolina through the acquisition of Applied Clinical Concepts Inc (ACCI) and Duke Clinical Research Institute Pharmacy (DCRIP) which merged to form Clinical Trial Services based in the Research Triangle Park, Durham.

“This latest investment and increase in capacity at our Durham facility is a sign of our continuing commitment to offer market driven solutions to our client base,” says Donna Christopher, Global VP Operations, Almac Clinical Services. We are delighted to mark our 20^th year in the US with such a significant announcement – once again reinforcing our dedication to global expansion.”

Having experienced tremendous success in the North Carolina state over the past 16 years, it has been recognised as a significant hub for growth. Almac’s $5.2 million investment will see the expansion of its Clinical Services facility along with the development of its Diagnostics and Clinical Technologies operations based in the same area. Almac currently employs over 1,600 individuals across 6 facilities in the US, and almost 3,000 people based in Europe and Asia.

Closing in on its fifth decade of operations, Almac is firmly established as a market leader in the provision of world-class pharmaceutical contract development and manufacturing services. With further expansion in Asia and acquisitions in the UK and Ireland recently announced, Almac’s footprint is stronger than ever, positioning the organisation to better assist its global clients by providing services in their own region.

Commenting on this 20 year milestone, Robert Dunlop, President & Managing Director, Almac Clinical Services said: “Almac’s commitment to our customers remains as strong as it was when we first opened in the US twenty years ago. Our ongoing success would be impossible without the support and loyalty of our dedicated employees who remain committed to Almac’s vision. We are delighted to announce further investment in our Durham facilities enabling us to continue to support our clients’ needs and meet the increased demands for our integrated services and I look forward to our continuing success over the next twenty years and beyond.”

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Almac Publish Second Validation of Stage II Colon Cancer Recurrence Assay in the Journal of Clinical Oncology

admin — Mon, 08 Aug 2016 08:22:17 +0000

Craigavon, N.I., UK, – Monday 08 August 2016 Almac Group’s Diagnostic Services business unit today announced the publication of the second validation study of their stage II colon cancer recurrence signature ColDx in the Journal of Clinical Oncology (JCO).

The publication entitled ‘Association Between Results of a Gene Expression Signature Assay and Recurrence-Free Interval in Patients With Stage II Colon Cancer in Cancer and Leukemia Group B 9581 (Alliance)’ demonstrates that the ColDx assay is a significant, independent predictor of recurrence-free interval (RFI) in stage II colon cancer therefore indicating it’s potential utility with the traditional clinical markers of risk to refine patient prognosis.

The study was performed in conjunction with the Alliance for Clinical Trials in Oncology (Alliance) comprised of investigators from renowned institutions such as Duke University, Dana-Farber Cancer Institute, University of Chicago, Brigham and Women’s Hospital and Queen’s University Belfast.

This large, independent clinical validation study utilised data and samples from 393 stage II colon cancer patients enrolled in the phase III CALGB (Alliance) 9581 clinical trial to assess the ability of the prognostic, 634-probe gene expression signature (ColDx) to improve upon current methods of differentiating patients as higher versus lower risk of recurrence within five years post-surgery. The signature remained significant after adjustment for conventional prognostic risk factors (hazard ratio = 2.13; 95% CI, 1.3-3.5; p < 0.01), including micro-satellite instability (MSI), T-stage and number of nodes examined.

Professor Richard Kennedy, MD, PhD, VP and Medical Director, Almac Diagnostic Services and McClay Professor in Medical Oncology, Queen’s University Belfast commented “These findings confirm our previous independent validation results which were also published in the Journal of Clinical Oncology in 2011 and further substantiates the ColDx assay as an effective prognostic biomarker for stage II colon cancer. The ability to accurately stratify stage II colon cancer patients into low and high risk categories provides invaluable information, ensuring clinicians are better informed when deciding the most appropriate treatment for their patients.”

The ColDx assay has been out-licensed and is currently being marketed by Helomics® Corporation under the name GeneFx® Colon in the United States.

About Almac Diagnostic Services

About Almac Group

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information visit almacgroup.com or e-mail media@almacgroup.com

About Helomics® Corporation

Helomics® is a comprehensive personalized healthcare company, bringing the next generation of diagnostics to the oncology field. Helomics is dedicated to improving patient outcomes by providing a comprehensive personalized tumor profile utilizing a proprietary set of laboratory platforms that leverage both live and fixed cellular analysis to allow physicians to personally characterize malignant tumors. Helomics’ novel molecular and cellular markers and bioinformatics services are designed to support treatment decisions by providing vital information based on the specific biological processes of each individual’s cancer.

Helomics is headquartered in Pittsburgh, Pennsylvania where the company maintains two CLIA-certified laboratories. For more information please visit: www.helomics.com.

About GeneFx® Colon

GeneFx® Colon is a microarray-based gene signature developed for FFPE tissue from stage II colon cancer patients. GeneFx® Colon is performed on a small amount of tissue, removed during surgery and identifies patients at higher risk of recurrence within 5 years following initial surgery. GeneFx® Colon is expected to provide better-informed and more personalised treatment decisions for the physicians and patients facing this disease.

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Almac Group’s Integrated Development to Commercialisation Services Support Amicus Therapeutics’ First Commercial Orphan Drug Product

admin — Tue, 02 Aug 2016 09:08:16 +0000

Craigavon, N.I., UK, – 2 August 2016 – Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long-term client partner, Amicus Therapeutics on the European approval of its first orphan drug product and precision medicine Galafold™ (migalastat, also referred to as AT1001). Galafold was approved as a first line therapy for long-term treatment of adults and adolescents (aged 16 years and older) with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation.

The Almac / Amicus partnership began in 2009 when Amicus sought an outsourcing partner for Phase III clinical manufacture and packaging of its solid oral AT1001 compound. Almac’s Pharmaceutical Development and Clinical teams worked with Amicus to advance the drug product through scale up, registration and now onwards into commercial supply. Almac is manufacturing and packaging the drug product and supporting Galafold’s launch across Europe from its UK Headquarters in Northern Ireland.

Leveraging the Almac advantage of integrated development and commercial services ensured a smooth transition from development to commercialisation for Amicus. Utilising the experience of Almac’s multidisciplinary product launch team incorporating quality, packaging design, regulatory and distribution, aided Amicus in navigating EU market requirements. Upon marketing authorisation (MA), Galafold was packed and distributed to the German market within hours ensuring patients’ needs were met as quickly as possible.

David Downey, Vice President, Commercial Operations at Almac commented “It’s great to see the launch of this precision medicine addressing a debilitating unmet medical need and it is gratifying to have played our part in its development and commercialisation. Amicus drew upon many of the services Almac has to offer, from development, through clinic, and into commercialisation. We look forward to a growing partnership as Amicus services the needs of the Fabry patient population who have an amenable mutation.”

“Providing quality drug product and sufficient drug supply is critical to ensuring a successful launch of Galafold for Fabry patients who have an amenable mutation,” said Enrique Dilone, Ph.D., RAC, Senior Vice President, Technical Operations at Amicus Therapeutics, Inc. “Almac has been an outstanding outsourcing partner for Amicus and we look forward to continuing the relationship as Galafold becomes available across the EU.”

About Almac’s Commercial Services

With over 40 years’ experience and commercial facilities in the UK and US, our global reach and local expertise provides flexible, quality led commercial solutions.

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.comor e-mail media@almacgroup.com.

About Amicus Therapeutics

Amicus Therapeutics is a biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other lysosomal storage disorders.

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Almac Group’s Rapid Launch Services Support U.S. Approval of Intercept Pharmaceutical’s First Commercial Orphan Drug Product

admin — Thu, 14 Jul 2016 08:23:17 +0000

Craigavon, N.I., UK, – 14 July 2016 – Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long-term client partner Intercept Pharmaceuticals, Inc. on the U.S. Food and Drug Administration (FDA) approval of their first orphan drug product obeticholic acid, marketed in the US as Ocaliva®. Ocaliva has been granted accelerated approval for the treatment of primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The partnership between Intercept and Almac commenced in 2013, with Almac’s Pharmaceutical Development teams supporting the early phase development of various dosage forms of Ocaliva. Building on this partnership, Almac’s commercial teams have worked with Intercept for the commercial packaging including packaging design & artwork of the now FDA approved drug product Ocaliva.

Intercept received accelerated FDA approval on Friday, 27th May 2016, and utilising Almac’s commercial Rapid Launch program, delivered from its Audubon, Pa. commercial packaging facility, Ocaliva was successfully packed and distributed on Tuesday, 31st May after the Memorial Day holiday to Intercept’s specialty pharmacy network.

Almac will also support the anticipated EU launch of obeticolic acid, if Intercept receives marketing authorisation, together with bulk drug product manufacture from its commercial manufacturing and packaging facility at its UK Headquarters in Craigavon, Northern Ireland.

David Downey, VP Commercial Operations, commented, “Leveraging development and commercial teams, located both in the UK and US, illustrates Almac’s value proposition of service and team integration. This approach reduced lead-time, mitigated risk and managed challenges, which led to a successful rapid launch within 48 hours of FDA approval over a Memorial Day weekend. My congratulations to all those involved.”

“Our collaboration with Almac will help address the unmet need in PBC by bringing Ocaliva to U.S. patients living with the disease,” said Richard Lancaster, Senior Director, Product Development at Intercept. “We look forward to a continued partnership as we prepare for the anticipated EU approval.”

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.comor e-mail media@almacgroup.com.

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Successful Inspection by FDA of Almac Clinical Services North Carolina Facility

admin — Tue, 14 Jun 2016 09:34:30 +0000

Durham, N.C., USA – 13 June 2016 – Almac Group, the global contract development and manufacturing organisation, is pleased to announce that it’s Clinical Services Business has completed a successful inspection of their Durham, North Carolina facility.

The inspection was concluded on Wednesday, 8 June, 2016 by the US Food and Drug Administration (FDA).

The non-scheduled FDA visit lasted three days. The inspection was extensive and a variety of documentation including validation, e-records, and audits were reviewed. The requested documents covered deviation, change control, data integrity, and training. There were no verbal or written observations and consequently no 483 was issued.

Christi Gimber, Director of Quality at Almac Clinical Services commented on the inspection:

“We are delighted with the results of this latest inspection. Almac prides itself on delivering an exceptional level of quality and complete adherence to best practice for our industry. The inspector commented that we are doing GXP training the way it should be done and was very impressed with the program and the variety of topics covered. He also noticed from review of the Site Master File that most of our staff have been with Almac for many years and felt that said a lot about the kind of company Almac is. I would like to thank all the staff who supported the inspection. The result is a testimony to the dedication and effort of our employees who are committed to ensuring that the highest standards are always delivered by Almac.”

About Almac Clinical Services

Almac Clinical Services provides the most comprehensive global clinical supply chain solution in the marketplace. Guided by extensive supply experience, they provide the physical resources and supportive technologies that ensure their client’s clinical supply chain continually delivers across the globe.

Almac’s Durham, North Carolina site was opened in 2000 and currently employs over 300 employees. Almac Clinical Services also have facilities in Pennsylvania and San Francisco, as well as numerous locations across the globe.

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Almac Diagnostic Services Expand Companion Diagnostic Development Service Offering with NanoString Barcoding Technology

admin — Wed, 08 Jun 2016 08:19:36 +0000

Craigavon, N.I., UK, – 24 May 2016 Almac Group’s Diagnostic Services Business Unit today announced that it has expanded its range of Companion Diagnostic Development platforms to include NanoStrings’s nCounter Dx Analysis System with FLEX – a multiplexed diagnostic testing platform.

Almac Diagnostic Services is a personalised medicine company focused on the discovery, development and commercialisation of diagnostic and companion diagnostics tests. Almac’s global CLIA-accredited high-tech laboratories based in Craigavon, UK and Durham NC, USA are ready to operate both research-use-only and clinical diagnostic assays from a range of platforms including microarray, qPCR, NGS and IHC. Almac’s recent investment in NanoString’s novel digital molecular barcoding technology further supports our commitment to CDx partnerships, providing an additional platform choice on which to validate discoveries and translate them into clinically useful diagnostic assays.

NanoString’s nCounter Dx Analysis System with FLEX is a flexible platform used to translate oncology signatures from research to the clinic. The system supports research and development of clinical applications from basic discovery to the development of future molecular diagnostic tests on a single platform. Providing simple, multiplexed digital profiling of single molecules, the NanoString platform represents a natural, digital downstream companion to next-generation sequencing.

The nCounter system is uniquely positioned to support translational research on account of its ability to generate high-quality data from the difficult sample type’s common in clinical research, including Formalin-Fixed Paraffin-Embedded (FFPE) tissues.

NanoString’s new barcoding chemistry for the nCounter platform is a triple play, offering the ability to detect DNA, RNA, and proteins from the same sample and to harmonize the data analysis.

Professor Paul Harkin, President and Managing Director of Almac Diagnostic Services commented: “Almac offers significant expertise in the discovery, development and delivery of multiplex RNA, DNA and protein based tests and currently partners with a number of major biopharmaceutical companies to assist with companion diagnostic development. Almac’s investment in the NanoString nCounter systems serve to provide an additional platform for the delivery of complex assays expanding the options available to Almac partners.”

Find out more:

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Almac Appoints New Vice President of Corporate Marketing

admin — Thu, 02 Jun 2016 12:39:38 +0000

Craigavon, N.I., UK – 2 June 2016 – Almac Group, the global contract development and manufacturing organisation is pleased to announce the appointment of Kevin Reid to the position of Vice President of Corporate Marketing.

Kevin’s role will be to lead Almac’s Global Corporate Marketing team, support each of Almac’s business units in the design, management and implementation of their marketing plans as well as driving the overall Almac Group communications.

Kevin brings to this role extensive Corporate Marketing experience. Most recently he held the lead marketing position with BDO Ireland and previously headed up the marketing function for Associated Newspapers Ireland. Kevin’s experience also includes management roles with Planet 24 Television and Carlton Television. He graduated from the University of Stirling with a BA Hons in History before continuing his studies at the University of Strathclyde and gaining a Bachelor of Law (LLB).

Alan Armstrong, CEO of Almac Group commented:

“We are delighted to welcome Kevin to Almac. His impressive track record in management and marketing will bring a wealth of experience and support to the existing global marketing team. We know that Kevin will have a profound impact on the delivery and success of Almac’s future expansion plans.”

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Almac to partner with ZYMtronix to deploy its universal enzyme immobilisation platform

admin — Mon, 23 May 2016 08:37:49 +0000

ZYMtronix and Almac are collaborating on a National Science Foundation (NSF) sponsored project focusing on the stabilisation and immobilisation of metabolic enzymes for biooxidation applications. These enzymes have the potential to be powerful tools for accessing difficult to synthesise drug metabolites and oxidation products. However, they can be relatively unstable under chemical processing conditions and difficult to use in production.

“Almac is the ideal partner for ZYMtronix to deploy its universal enzyme immobilisation platform to enhance Almac’s monooxygenase enzyme collection. The project will allow both companies to provide the industry with efficient immobilised catalysts for mild and selective oxidation of chemical intermediates and APIs with reduced production costs,” said Dr. Stéphane Corgié, CEO of ZYMtronix.

Professor Tom Moody, Head of Biocatalysis at Almac commented:

‘We look forward to adding ZYMtronix technology to our expanding biocatalysis capabilities. Although monooxygenases have great potential for efficient synthesis of otherwise difficult to access products, implementation has been limited by slow reaction rates and need for high enzyme loadings. ZYMtronix technology has the potential to overcome these limitations.’

About Almac Group

‘Partnering to Advance Human Health’

Almac Group has supported the global biopharmaceutical industry with their drug development activities and bringing new drugs to market to advance human health for more than 40 years. Privately owned and headquartered in Craigavon, Northern Ireland, the company employs in excess of 4,000 personnel in the United Kingdom, United States and Asia. Almac’s commitment to quality is guaranteed through a comprehensive range of standard operating procedures and fully documented quality systems developed in accordance with global pharmaceutical guidelines. Almac’s research targets five main branches: diagnostics, sciences, clinical services, clinical technologies and pharmaceutical services. The Almac Biocatalysis group, led by Prof. Tom Moody, consists of computational, molecular- and microbiologists, enzymologists, organic chemists and analysts; the group has demonstrated expertise in gene identification, expression, enzyme evolution, fermentation, enzyme production and biotransformation scale-up. Expertise ranges from enzyme production to the synthesis of complex chiral APIs from milligram to ton scale.

About ZYMtronix

‘Biocatalysis in Motion’

ZYMtronix Catalytic Systems, Inc. (DBA ZYMtronix, Inc.) is a life science company formed in 2013 as a spin-off from Cornell University research. The company provides the industry – pharmaceutical and enzyme manufacturers – cost-effective solutions to maximize the use of enzymes in drug discovery and drug manufacturing. In traditional chemistry, making pharmaceutical drugs requires a long series of labor-intensive, expensive reactions, but employing immobilized enzymes cuts the number of necessary reactions and can reduce energy and the use of hazardous chemicals. The founders, Stéphane Corgié, PhD (CEO-CTO) and Juan Diego Alonso JD-MBA (CFO) are joined by Dr. Joseph Marasco who leads the company’s business development efforts as Chief Business Officer of Pharmaceutical Operations.

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The Almac Pod™ – Changing the Dynamics of Temperature Controlled Shipping Solutions

admin — Mon, 09 May 2016 15:51:03 +0000

Craigavon, N.I., UK, 9 May 2016 – With the rise of biologics and the introduction of strict Good Distribution Practices (GDP), Almac has recognised the need for a change in dynamics of temperature controlled shipping, with the launch of their new Almac Pod™ service solution.

Understanding the cost, logistical, and compliance challenges posed by this changing environment, the Almac Pod™ is a first-to-market service solution that incorporates the efficiencies of the Almac-approved, global courier network and advanced phase change technology (PCM) to create a temperature-controlled shipping service solution that eases the burden for their global clinical supply customers.

The Almac Pod™ offers a Protected, Optimised and Dynamic solution that safeguards customers’ products and mitigates against temperature excursions of all clinical shipments– the perfect solution for Biologics or difficult to handle products. Since launching the service, the Almac Pod™ has been 100% effective in protecting the integrity of shipped products with no known temperature excursions within the shipper qualification period.

Andrew Scott, Head of Logistics (EU) commented:

“I am delighted to announce the success of our new temperature-controlled shipping service solution – the Almac Pod™. With rapid growth in the volume of our controlled temperature shipments over the past few years, the introduction of innovative solutions such as the Almac Pod™ allows us to deliver on the growing needs of our clinical trial supply customers. The service has enabled us to achieve a major step up in protection for temperature controlled products during transit that competes head to head with the traditional water based solutions. The Almac Pod™ is fully GDP-compliant and is available as part of Almac’s end-to-end, global supply chain management solution – your product, safe in our hands.”

For further details on the Almac Pod™, download the whitepaper: Changing the Dynamics of Temperature Controlled Shipping solutions here.

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Almac Clinical Technologies Announces Participation in the Avoca Diligent Prequalification Platform

admin — Mon, 25 Apr 2016 08:10:57 +0000

Diligent Leverages Avoca Quality Consortium Standards Improve Quality and Reduce Cycle Time in the Prequalification of Technical Providers.

Souderton, PA., USA, – 25 April 2016 – Almac Clinical Technologies, a member of the Almac Group and the world’s leading provider of Interactive Response Technology (IRT) is pleased to announce its participation in the Avoca Diligent Prequalification Platform. The purpose of this initiative is to increase quality, improve efficiency, reduce risk, and accelerate technical service provider onboarding by centralising aspects of prequalification activities.

Diligent started by engaging an expert Advisory Board from the Avoca Quality Consortium to develop Industry Standards for Prequalification of technical service providers. These standards were mapped, when possible, to health authority regulations or regulatory guidance. They underwent a rigorous review by The Avoca Group, The Advisory Board, and companies in the industry that deliver these technical services. Upon finalising the Prequalification Industry Standards, prequalification tools were developed that map back to these standards, including Request for Information (RFI) templates.

The Avoca Group has been inviting leading technical service providers to complete core and technical RFI templates and centralise them so they are readily available to sponsors (and CROs, if applicable), to speed up the process of prequalifying and onboarding new technical providers. Almac Clinical Technologies is an early adopter for this transformational initiative and invites sponsors and CROs to contact The Avoca Group at Diligent@theavocagroup.com to request these completed RFIs as needed to accelerate their review and onboarding of Almac Clinical Technologies for their clinical trials.

“The Avoca Group is pleased to have Almac Clinical Technologies as a participant in Diligent,” said Patricia Leuchten, CEO of The Avoca Group. “It demonstrates Almac’s commitment to moving the industry forward in driving quality, standardising and streamlining processes.”

Bill Kane, Director of Quality Assurance for Almac commented: “Almac Clinical Technologies has been an active member of the Avoca Consortium for a number of years now, and a strong supporter of sharing quality principles and establishing uniform industry quality standards. Our involvement with Avoca has been of exceptional business value to Almac and is yet another way for us to demonstrate our commitment of Quality to our many partners in the Clinical Development industry.”

About Almac Clinical Technologies

Almac Clinical Technologies helps the biopharmaceutical industry bring new therapies to those in need by empowering trial sponsors and CROs to proactively manage sites, patients, and clinical supplies through our industry-leading technology and expert consultancy. For over two decades, Almac Clinical Technologies has maintained its reputation for being the most trusted ally for enabling real-time control of the most critical elements in protocol execution.

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Almac Group Launches US Serialisation Solution in Partnership with Optel Vision

admin — Mon, 25 Apr 2016 07:50:47 +0000

Craigavon, N.I., UK, – 25 April 2016 – Almac Group, the global contract development and manufacturing organisation, is pleased to announce an expansion to its serialisation capabilities to include its US commercial packaging facility in Audubon, PA.

Building upon Almac’s in-house expertise and proprietary serialisation / track and trace solution developed at its UK headquarters, this technology expansion will address FDA regulations meeting the requirements outlined in the Drug Quality and Security Act together with meeting client demand for a local US, flexible, contract packaging serialisation provider.

Having assessed multiple vendors, Almac partnered with Optel Vision to provide a versatile line level solution (hardware and software) that integrated with Almac’s in-house proprietary level 3, site level software. This new serialisation solution is a high-spec standalone line that prints, verifies and aggregates saleable packs through to the pallet with reporting functionality to ensure the client can meet the traceability requirements of the various markets.

Grainne Hughes, Operations Manager at Almac explains “Having built our own serialisation line for the UK operations some years ago we developed a strong knowledge base. To expand the solution into our US operations we decided that we needed an experienced partner that could integrate with our innovative product serialisation site level software. The partnership with Optel Vision has provided our US commercial packaging facility with a truly flexible and adaptable solution to readily meet specific country, market and client requirements whilst ensuring serialisation to GS1 Standards.”

“We knew Almac had its own in-house solution for the UK and for the first Almac serialisation project in the US, we combined the knowledge of both companies to design a solution that meets Almac quality standards as well as the demand from global markets using the Optel Vision hardware and software solutions. The system is now operational and can be easily scalable for future needs.” says Yvon Lemay, Optel Vision Project Manager.

Almac US can now offer the flexibility to our Clients to serialise as part of the pack process, as part of a repackaging exercise, or as a stand-alone serialisation application to already packed product.

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.comor e-mail media@almacgroup.com.

Almac’s serialisation experts will be attending Interphex New York (26 – 27 April) and Making Pharmaceuticals Birmingham (26 April).

About Optel Vision

Optel Vision is the leader in providing the most technically advanced systems for Vision Inspection and Track & Trace Solutions. Optel Vision’s systems ensure the safety of manufactured goods by inspecting package integrity and applying anti-counterfeiting measures.

For more information visit www.optelvision.com.

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Almac Wins Three CMO Leadership Awards

admin — Wed, 23 Mar 2016 15:48:36 +0000

Craigavon, N.I., UK, – 23 March 2016 We are pleased to announce that we have once again been selected as winners at this years’ CMO (Contract Manufacturing Organisation) Leadership Awards for the fifth year. The award was presented to VP of Commercial Operations, David Downey at an exclusive ceremony and reception in New York last week (16 March).

The awards are developed by Life Science Leader with the sole purpose of recognising the industry’s top CMO’s. The research was carried out by Industry Standard Research (ISReports.com) and based on their Contract Manufacturing Quality Benchmarking annual online survey. More than 80 contract manufacturers were evaluated on 26 different performance metrics.

There are five CMO Leadership Award core categories: Quality, Reliability, Capabilities, Expertise, and Compatibility. Multiple performance metrics feed into each of these award categories to give added confidence to Almac. Almac has emerged as the winner of three of these categories:

COMPATIBILITY – Met customers’ expectations
QUALITY – Met customers’ expectations
RELIABILITY – Met customers’ expectations

David Downey, VP Commercial Operations commented:

We are pleased to have received yet another CMO Leadership Award for these three key categories. We pride ourselves on our ability to provide high quality, flexible and innovative solutions to meet our global clients’ requirements and these awards are recognition of our teams’ ongoing commitment to deliver just that.”

About Almac Group

‘Partnering to Advance Human Health’

Almac Diagnostic Services is one of six business units operating under the ownership of the Almac Group. The global company partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics. In addition, Almac Diagnostic Services has a pipeline of proprietary oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Almac Group Opens Additional Companion Diagnostic Laboratory in Durham NC USA

admin — Tue, 08 Mar 2016 12:43:46 +0000

Craigavon, N.I., UK, – 08 March 2016 Almac Group’s Diagnostic Services Business Unit today announced the opening of their new companion diagnostic development facility located in the Research Triangle Park region of North Carolina, USA. The North Carolina facility will provide a US base to support Almac’s increased demand for its CDx development partnerships as well as a CLIA-accredited laboratory to support the downstream delivery of assays for patient testing.

Along with headquarters in Europe and partnerships in Asia, the new facility in the US will provide Almac Diagnostic Services with a strong global presence to continue to meet increasing customer demand and to support their growing client base.

The custom designed facility is located amongst one of the most prominent high-tech research and development centres in the world and contains molecular biology laboratories as well as office space. The state of the art laboratory is equipped with microarray and qPCR platforms appropriate for companion diagnostic development and will operate both research-use-only and clinical diagnostic tests. Plans are also in place to add additional technology platforms including NGS in the coming year.

‘The opening of our new CDx facility in the US is Almac Diagnostic Services’ latest initiative to better serve our global Biopharma partners. As we experience increased client demand for our companion diagnostic development services, this latest expansion will significantly enhance Almac’s offering, increasing capacity and further demonstrating our commitment to personalised healthcare’ said Professor Paul Harkin, President and Managing Director of Almac Diagnostic Services.

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Almac Group Win Irish American Business Chamber Award in USA

admin — Wed, 02 Mar 2016 19:11:46 +0000

Craigavon, N.I., UK, – 2 March 2016 – The Almac Group has become the first company from Northern Ireland to be presented with the prestigious Ambassador Award for 2016 by the Irish American Business Chamber and Network.

The Ambassador Award is given annually to a member company that has helped to carry out the Chamber’s mission of strengthening business and educational ties between Ireland and the United States. Kevin Stephens, Finance Director of the Almac Group received the award from Barbara Jones, Irish Consul General to the USA on behalf of Anne Anderson, Irish Ambassador to the USA at a ceremony in Philadelphia, USA.

Thanking the Chamber Kevin Stephens said,

“It is a real privilege to accept the Irish American Business Chamber Ambassador Award for 2016 on behalf of the Almac Group. It is even more of an honour to be the first company in Northern Ireland to receive this accolade. It is a very welcome recognition of our ongoing contribution to the economies of both the US and Northern Ireland and something of which we can all be very proud.”

The Almac Group employs almost 1,500 people in its operations in Pennsylvania, North Carolina and California.

The Irish American Business Chamber and Network Ambassador Awards primary purpose is to promote the interests of its members and the development of economic and educational relationships between the US, Ireland and Northern Ireland.

About Almac Group – ‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through tocommercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 4,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For further information, visit almacgroup.com or e-mail media@almacgroup.com.

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NEW Fluorescence Lifetime Platform Unveiled at SLAS

admin — Mon, 25 Jan 2016 16:01:58 +0000

Melbourn, UK, 20 January 2016. Combining their well-established expertise in drug discovery automation plus peptide and protein engineering and manufacture, TTP Labtech and Almac Group have formed a strategic partnership to bring you a fully integrated fluorescence lifetime platform. Being launched on Booth 621 at the Society for Laboratory Automation and Screening (SLAS) Conference in San Diego, USA the new platform comprises TTP Labtech’s new ameon^® lifetime reader and Almac’s FLEXYTE^® lifetime assays and reagents for precise lifetime assays, to provide a simple one-stop shop for robust, cost-effective drug screening and profiling.

On the booth, the new compact ameon lifetime reader will be on show which offers a step-change in lifetime data acquisition. Experts will also be on hand to explain how the reader can be combined with FLEXYTE lifetime reagents for the screening of common drug targets such as protein kinases and proteases, as well as challenging epigenetic targets. Applying such a powerful combination allows researchers to reduce compound-related assay interference, select fewer false leads and obtain the reliability normally associated with biophysical methods at the compound screen stage.

For scientists wanting to find out more about the unrivalled advantages of this accessible lifetime technology, there is a lunch tutorial entitled “An exciting talk: use of fluorescence lifetime technologies for high-throughput protein kinase screening and profiling” delivered by leading industry speakers on Monday 25th January from 12.30-13.15 in Room 1A. Please click the link to register https://discover.ttplabtech.com/SLAS-2016-lifetime-workshop.html. There are also poster presentations from AstraZeneca and GlaxoSmithKline detailing their recent experience with the platform.

Dr Wayne Bowen, CSO at TTP Labtech, stated: “We have listened, and in partnership with major pharma companies, have developed an intelligent approach to improve the efficiency of compound screening. Most screening methodologies continue to be impacted by too many false hits and the limited throughput of orthogonal biophysical technologies; the intrinsic robustness of Almac’s FLEXYTE lifetime reagents coupled with the precision of TTP Labtech’s new ameon lifetime reader sets a new benchmark for cost-effective screening through better discrimination of lead compounds at an earlier stage within the drug discovery process.”

Dr Charles Shields, VP of Peptides & Small Molecule API at Almac commented: “We believe that the strategic partnership between TTP Labtech and Almac will bring to the screening community a true step-change in assay performance with the ability to uncover previously obscured leads and the potential to access new chemical space.”

About TTP Labtech – natural innovators

From its global headquarters based near Cambridge, UK, TTP Labtech creates, designs and manufactures robust and innovative automated laboratory instrumentation and consumables for both the academic and industrial sectors of pharmaceutical and biotech research.

TTP Labtech is part of TTP Group plc, a company that originated from The Technology Partnership (TTP) which is Europe’s leading independent centre for innovation. Since 2002, TTP Labtech has successfully combined cutting edge science with first rate engineering. Innovation is at the core of the company and is illustrated by the passion and expertise of its personnel and evidenced by the novel products and technologies that are brought to market.

TTP Labtech provides state-of-the-art solutions developed for specific product areas: cell-based screening (acumen Cellista^®, mirrorball^®); sample management (comPOUND^®, arktic^®, lab2lab) and low volume liquid handling (mosquito^®, dragonfly^®).

For further information, please visit www.ttplabtech.com.

About Almac Group – ‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

For further information, visit almacgroup.com or e-mail media@almacgroup.com.

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Almac Group to Collaborate with Illumina on Next-Generation Sequencing Based Companion Diagnostic Development

admin — Thu, 12 Nov 2015 08:56:12 +0000

Craigavon, N.I., UK, – 12 November 2015 – Almac Diagnostic Services today announced that it had entered into a collaboration with Illumina, Inc. (NASDAQ: ILMN) to establish a framework for the development of next-generation sequencing (NGS)-based companion diagnostic assays.

The collaboration enables Almac to develop next-generation sequencing (NGS) assays using the Illumina MiSeqDx® instrument, the first FDA-cleared IVD NGS system designed specifically for the clinical laboratory environment.

Almac offers significant expertise in the development and delivery of multiplex RNA and DNA based tests and currently partners with a number of major biopharmaceutical companies to assist with companion diagnostic development. The collaboration with Illumina serves to provide an additional platform for delivery of complex assays expanding the options available to Almac partners.

‘We are extremely pleased to announce this collaboration with Illumina. We are fully committed to the development of precision medicine and partnerships of this nature provide more avenues for test delivery, enabling development of diagnostic tests which will ultimately improve care in a wide range of disease areas,’ said Professor Paul Harkin, President and Managing Director of Almac Diagnostic Services.

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.com or e-mail diagnostics@almacgroup.com.

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Almac Group announces significant expansion in pharmaceutical development capacity

admin — Mon, 09 Nov 2015 08:36:27 +0000

Craigavon, N.I., UK, – 09 November 2015 – Almac Group, the global contract development and manufacturing organisation, has confirmed a £16 million investment to expand its formulation and analytical development services to meet ongoing client demand.

The company announced the successful conclusion to negotiations to operate a significant proportion of the 70-acre Charnwood Campus in Loughborough, England – a world-class science, technology and enterprise park. Specifically, Almac will occupy the formulation development and analytical testing facilities at the site which will complement existing development & GMP services offered from its Craigavon NI Headquarters.

The Charnwood facilities were originally designed and built by a global Pharma company as part of its in-house formulation development, clinical manufacturing & analytical testing capabilities. Almac has now commenced recommissioning of the facilities with operations focusing initially on expanding both non-potent and potent solid oral dose processing, creating approximately 180 new jobs in the next 5 years. With an initial investment into the Charnwood site of ~£16m in process and analytical technologies, an operational start date is targeted for Q1 2017.

Graeme McBurney, Managing Director, Almac Pharma Services commented: “As we experience increased client demand for our pharmaceutical development and niche commercial manufacturing services, this latest expansion will significantly enhance Almac’s offering, increasing capacity and capability and further demonstrating our continued commitment to support our global clients in the development and manufacturing of their drug products.”

About Almac Group
‘Partnering to Advance Human Health’

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Almac Acquires Arran Chemical Company and Expands Biocatalysis Services

admin — Tue, 03 Nov 2015 13:56:56 +0000

Craigavon, N.I., UK, – 03 November 2015 – Almac Group, the global contract development and manufacturing organisation, today announced the acquisition of 100% shares of Arran Chemical Company, an independent and privately owned organisation based in Athlone, Ireland.

The addition of Arran Chemical Company marks a new chapter in Almac’s continuous growth, with significant increase in scale (a range of reactors up to 6,300L and total capacity of up to 45m³) the new combined business will integrate Biocatalysis technology with large scale intermediates manufacture.

Located in County Roscommon, just two hours away from Almac Group’s Headquarters, the existing Arran Chemical Company specialises in the manufacture of products for the pharmaceutical, flavour/fragrance, personal care and other specialised chemical and industrial applications. Both companies have more than 25 years’ experience and have been working together closely on multiple projects over the past 5 years.

The bespoke facility offers a full range of scales including kg lab, multi-purpose pilot plant and manufacturing plant. Arran’s assets strongly complements Almac Sciences’ existing business and will allow both entities to continue growing in their respective market.

“This is a very exciting opportunity for both Almac and Arran Chemical Company.” said Dr Stephen Barr, Managing Director, Almac Sciences. “Based on our combined strength, scale and technology, we will offer commercial products and pharmaceutical intermediates using our current world leading Biocatalysis technology platform enabling us to address our global clients’ growing demands for a high quality, integrated, efficient service and we are delighted to be able to support our clients in this way.”

Anthony Owens, Managing Director, Arran Chemical Company commented “We are very pleased with this significant development which enables us to continue to deliver high quality products to our global customer base in addition to offering a broader range of solutions. This move builds on our established presence in the industry and we look forward to merging our expertise and experience with Almac’s undoubted success to match the increasing requirements of customers across the whole spectrum of the industry.”

About Almac Group

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 3,900 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Industry’s Newest Generation IRT Fuels Growth of Almac Group’s Business

admin — Mon, 12 Oct 2015 07:43:49 +0000

A Majority of Top 15 Pharmaceutical Companies Have Committed to Using IXRS® 3 Across Development Programmes

Souderton, PA., USA, – 12 October 2015 − Almac Clinical Technologies, part of the Almac Group, a global leader in technology for managing clinical trial patients and supplies, is continuing to grow on the strength of its newest solution: IXRS® 3. Less than a year after launching the company’s latest generation Interactive Response Technology (IRT), a majority of the industry’s top 15 biopharmaceutical companies have committed to adopting the IXRS 3 platform.

Concurrently, Almac has seen consistent growth in demand for deployment of new programmes among leading Contract Research Organisations (CROs) seeking a technology partner that shares the vision of long-term success through quality and stability. Due to this uptake, Almac is seeking to attract additional top talent to its existing roster of experts in the eClinical solutions space.

President and Managing Director of Almac Clinical Technologies, Valarie Higgins, relates the overwhelming market response and subsequent expansion of the business to the need for greater efficiencies throughout the clinical development process, and the supply chain in particular. “Operational success is increasingly dependent upon a company’s focus on innovation and its ability to rely on technology partners to consistently deliver high quality data,” Valarie maintained. “I am also proud to report that due to this growth, we are actively hiring. We have a robust team of experts in place and are now looking to hire more of the brightest minds in the industry.”

A Pre-Configured Core that is Easily Customised

IXRS 3 is designed to automate daily tasks for investigator sites, sponsors and CROs in the management of patient events and drug inventory throughout the lifecycle of clinical trials. The proprietary software is pre-configured with the features and functions that most trials require, while the underlying architecture makes it easy to customise quickly for any given sponsor, programme or trial.

“IXRS 3 is all about solving complexity challenges and providing real-time control of protocol execution.” explains Valarie. “And that begins with rapid deployment. In the past, trial timelines could derail because of the complexity involved in configuring and adjusting the technology. But, no more. We’ve struck the perfect balance between features and functions that are built-in and those that can—and should—be bespoke for each installation. And that saves time and money in the development phase.”

Role-Specific Access and Capabilities

IXRS 3 is readily configurable—both at start up and as the study progresses—and caters to the needs of various different user types within sponsor organisations, CROs and trial sites. Self-service features allow users to change settings as befits their role and responsibilities without having to ask Almac support services for help. The system includes personalised services for:

Investigator Sites. The site-facing tool is unobtrusive, yet simplifies patient activities and automate steps that are prone to human error.
Supply Chain Managers. The system provides alerts and re-supply options to keep product supplies at optimum levels.
Study Management Teams. At-a-glance trial metrics and alerts help monitors prepare for site visits.
Clinical Operations. Easy-to-read dashboards show key patient metrics in real time to support constant performance monitoring.
Data Managers. Real-time data replication and pre-built integrations with leading EDC and CTMS contribute to higher quality source data—and fewer data discrepancies.
R&D Leaders. Sophisticated delivery and relationship management processes ensure compliance, ease the burden of vendor oversight and minimize the amount of training required.

Ongoing Innovation and Economies of Scale

When IXRS 3 is used alongside Almac’s services in product packaging, labelling, distribution, reconciliation and destruction, sponsors benefit from seamless alignment across all interdependencies in the global supply chain. “By synchronising the digital and physical supply chains in a closed-loop system, companies gain optimal visibility and efficiency,” added Valarie. “We’re able to engineer out costs, bake in standards and improve processes and system functionality.”

To find out more, please visit our website at almacgroup.com.

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Almac Group Addresses Industry Demand for Multiparticulate Drug Products with Scalable Fluid Bed and Encapsulation Technologies

admin — Wed, 07 Oct 2015 08:22:02 +0000

Craigavon, N.I., UK, – 07 October 2015 In response to increasing client demand for multiparticulate drug delivery systems, Almac Group, the global contract development and manufacturing organisation, is providing fluid-bed processing and encapsulation services to its global partners from its UK development and commercial manufacturing facilities.

Multiparticulate systems — including pellets, beads, granules and mini-tablets — are typically formulated to optimise drug performance, enhance patient tolerance and safety and extend patent protection. Development and scale-up of these dosage forms can be challenging, however, Almac’s clients are seeking the technical expertise and equipment capabilities that provide scalable solutions.

Almac’s most recent addition in multiparticulate technologies is focused on commercial-scale support. Almac has qualified both a Glatt GPCG PRO 120 fluid bed processor and an IMA Adapta 100 high speed encapsulator. The Glatt accepts modular inserts for each of the three common fluid bed processes: bottom spray, top spray or drying. Most recently, Almac’s development and commercial teams have successfully registered and commercially manufactured a product at 250kg scale using the bottom spray Wurster insert. Utilising the dedicated fluid bed drying / encapsulation suite, multiparticulates from those batches were then filled into capsules using our Adapta 100, which has a high throughput capacity of up to 100,000 capsules per hour and an integrated online checkweigher with feedback loop to maintain high yields.

As John McQuaid, VP Technical Operations at Almac, explains “Having both small and large scale fluid-bed and encapsulation technologies allows us to meet our clients’ needs for multiparticulate drug products from early phase clinical supplies through to ongoing commercial demand. Our clients benefit from a single-partner and single-site approach that eases tech transfer, provides scientific continuity and delivers savings in terms of both time and cost.”

About Almac Group

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 3,700 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information visit almacgroup.com or e-mail media@almacgroup.com.

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Almac Group’s Integrated CMC Services Support US Approval of Wellstat Therapeutics’ First Commercial Orphan Drug Product

admin — Wed, 09 Sep 2015 11:02:19 +0000

Craigavon, N.I., UK, – 9 September 2015 – Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long term client partner Wellstat Therapeutics on the commercial approval of their first orphan drug product XURIDEN™ (uridine triacetate). XURIDEN has been developed as a treatment for the rare disease Hereditary Orotic Aciduria (HOA).

The partnership began more than 5 years ago with Almac’s Sciences and Pharma Services business units providing expert support to Wellstat Therapeutics for the development of both the Active Pharmaceutical Ingredient (API) and formulation of the drug product. Having manufactured clinical, registration and PV batches, Almac will now produce the commercial product from its UK headquarter facilities, on behalf of Wellstat Therapeutics.

Following a successful Pre-Approval Inspection (PAI) of Almac’s UK facilities in May of this year and the subsequent FDA approval of the product on September 4, 2015, XURIDEN is forecast to be commercially available in early 2016.

Leveraging Almac’s unique integrated API and Drug Product expertise prior to and through NDA submission and approval, Wellstat Therapeutics worked with Almac to take advantage of a single partner approach with smooth transition through the drug development process and now commercialisation, saving time, transfers and other uncertainties inherent in a multi-supplier process.

David Downey and Charles Shields, VP’s of Almac’s Drug Product and API teams respectively commented “It is great to see a product that Almac has supported long term in both development of the API and Drug Product achieve commercial approval. The value of integrating development and the flexibility it offers our partners cannot be overstated.”

“Until FDA approval of XURIDEN, there were no approved treatments for patients with hereditary orotic aciduria, a rare, potentially life-threatening disease”, said Michael Bamat, VP Research & Development for Wellstat Therapeutics. “Almac has been an integral part of the API and drug product development team for XURIDEN.”

About HOA

Hereditary orotic aciduria (HOA) is a genetic disorder caused by mutations reducing the activity of uridine monophosphate synthase (UMPS), which converts orotic acid to UMP. Uridine deficiency underlies many of the symptoms of HOA, including hematologic abnormalities, developmental delays, failure to thrive, and if untreated, early mortality. Orotic acid biosynthesis is normally subject to feedback inhibition by intracellular uridine nucleotides and is therefore overproduced in HOA. The resulting increased levels of orotic acid can cause crystalluria and occasional obstructive uropathy.

The goal of uridine replacement therapy in HOA is to provide the uridine that these patients cannot make adequately themselves in order to restore intracellular uridine nucleotide concentrations, enabling and supporting the biosynthetic functions of pyrimidine nucleotides and their derivatives, and also normalizing orotic acid production.

About XURIDEN

XURIDEN is a pyrimidine analog for uridine replacement indicated for the treatment of hereditary orotic aciduria. Oral administration of XURIDEN delivers 4 to 7 times more uridine than oral administration of uridine itself.

Important Safety Information

Contraindications – None

Warning and Precautions – None

Adverse reactions – No adverse reactions were reported with XURIDEN in patients with HOA

Pregnancy – There are no available data on XURIDEN use in pregnant women to inform drug-associated risk

Lactation – There are no data on the presence of XURIDEN in human milk, the effect on the breast-fed infant or the effect on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for XURIDEN and any potential adverse effects on the breastfed infant from XURIDEN or from the underlying maternal condition.

Pediatric – The safety and effectiveness of XURIDEN have been established in pediatric patients.

For the full Prescribing Information go to http://www.xuriden.com/FPI.pdf.

About Almac Group

‘Partnering to Advance Human Health’

For more information visit almacgroup.com or e-mail media@almacgroup.com.

About Wellstat Therapeutics

Wellstat Therapeutics Corporation is a privately-held biopharmaceutical company located in Gaithersburg, Maryland. Wellstat Therapeutics is committed to discovering, developing and commercializing products that will provide new and improved treatments for patients in the fields of oncology and metabolic, neurometabolic and neurodegenerative diseases. Wellstat Therapeutics is part of the Wellstat group of companies, http://www.wellstat.com. For more information, please visit the website at http://www.wellstattherapeutics.com.

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Almac Group’s Asia Pacific Headquarters Receives Official Health Science Authority (HSA) Accreditation

admin — Mon, 07 Sep 2015 08:28:04 +0000

Singapore, 7 September 2015

Following on the recent announcement; ‘Almac Group Expands Asia Pacific Presence with New Regional Headquarters and Clinical Trial Supply Facility in Singapore’ (10 July 2015) detailing the successful completion of the Health Sciences Authority (HSA) inspection of their new Asia Pacific headquarters in Singapore, Almac can now officially confirm that, as a result of this inspection, the facility has received full GMP accreditation.

“We’re delighted to obtain the Health Sciences Authority’s certification of our Singapore facility,” commented Paul O’Connor, Global VP of Quality for Almac Group. “This development makes Almac the first full service clinical trial packaging and distribution organisation to ever receive GMP accreditation and solidifies Almac’s commitment to provide the highest possible standard of service to our customers in Asia Pacific and indeed around the world.”

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,700 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information, please contact:

Ruder Finn Asia

Ayuni Ali

Senior Account Executive

D: +65 6336 8750

E: alia@ruderfinnasia.com

Prasanthi Nair

Account Executive

D: +65 6336 6742

E: nairs@ruderfinnasia.com

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Almac Group Expands Clinical Trial ‘Direct to Patient’ Service throughout Europe

admin — Mon, 07 Sep 2015 08:26:44 +0000

Craigavon, N.I., UK, 7 September 2015 Due to the overwhelming success experienced since the launch of its “Direct to Patient” shipping service for clinical trials throughout US and Canada in October last year, Almac has announced the expansion of this innovative service to EU countries.

The Direct to Patient offering guarantees all shipments are delivered direct to patients’ homes on time and without compromising product integrity, providing clinical trial sponsors a more cost effective approach to conduct their studies. Patient compliance, efficiency and experience is also improved as they are offered a flexible and convenient method to participate in trials that suit their personal circumstances. This home delivery service further enhances the existing end-to-end clinical trial distribution service provided by Almac by co-ordinating all clinical trial (including temperature and non-temperature controlled) material shipments from clinical sites directly to patient’s homes within the European Union.

“The success of the service experienced to date across the US and Canada is testament to the upsurge in demand for a more patient-centric method of performing trials and we are pleased to be able to now offer this to European countries.” said Donna Christopher, Almac’s Global VP Operations “Patient retention is often a significant concern associated with conducting clinical trials and Almac’s innovative Direct to Patient solution offers clear advantages to clinical trial patients and is yet another example of how we can ease the burden for sponsors.”

Find out more about Almac’s Direct to Patient service here.

For a full list of countries offering our Direct to Patient service please contact info@cts-almac.com.

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Almac Group Expands Asia Pacific Presence with New Regional Headquarters and Clinical Trial Supply Facility in Singapore

admin — Fri, 10 Jul 2015 11:22:58 +0000

Jim Murphy and Dr Robert Dunlop Officially Open Almac’s New Singapore Headquarters

Singapore, 10 July 2015 – Almac Group, the global contract development and manufacturing organisation, today announced the successful completion of the Health Sciences Authority (HSA) inspection of their new Asia Pacific headquarters in Singapore.The new facility, which officially opens on 10 July 2015, enables Almac to expand on the unique suite of clinical trial primary and secondary packaging, distribution, technology and consultation solutions offered from within the region. This allows Almac to even better serve their Asia Pacific pharmaceutical clients either conducting regional trials or expanding to international markets as well as global clients who are conducting pharmaceutical clinical trials in the region.“Asia Pacific is a vital region for us, as currently 23% of global clinical trials for new pharmaceutical products are being conducted here. By basing our regional headquarters and operations in Singapore, we are better equipped to support our Asia-based clients in their own time zone and languages”, said Dr Robert Dunlop, President & Managing Director of Almac’s Clinical Services business unit. “With the opening of our new Singapore facility, we are directly supporting studies run by regional and global pharmaceutical firms by providing critical manufacturing, packaging, supply chain management and Interactive Response Technology (IRT) support services in Asia Pacific.”

“We welcome Almac’s investment into the vibrant ecosystem of biomedical sciences companies in Singapore,” said Mr. Kevin Lai, Executive Director of Biomedical Sciences and Consumer Businesses, Singapore Economic Development Board (EDB). “Their decision reinforces Singapore’s reputation as a preferred location where companies manage their clinical development and supply chain management for the region and beyond.”

The Health Sciences Authority (HSA) inspection of the new facility ensuring standards of safety, quality and efficacy will make Almac the first full service clinical trial packaging and distribution organisation to ever receive GMP certification. This facility strengthens the Group’s global footprint with facilities in Europe, the US and Singapore, as well as satellite offices in Japan.

The Singapore facility has full-service equipment which includes primary packaging rooms, secondary packaging areas, frozen storage, label control room, a Just-in-Time (JIT) labelling suite and non-GMP storage area offering clients in the region a streamlined, personalised, turnkey solution which ultimately optimises their clinical trial.

For more information on Almac’s Asia Pacific Facility, click here.

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Almac Group Appoints New Vice President of Global Business Development

admin — Fri, 10 Jul 2015 11:18:16 +0000

Souderton, P.A. – 29 June 2015 – Almac Group, the global contract development and manufacturing organisation, today announced the appointment of George Tiger to the position of Vice President of Global Business Development for its Clinical Technologies business unit responsible for commercial operations and business development.Prior to joining Almac, Mr Tiger held the position of Senior Vice President, Life Sciences Sales for Health Market Science where he was responsible for the sales efforts across the life sciences industry. Prior to this, his experience includes over 12 years with ERT, a leading supplier of cardiac safety, respiratory, and eCOA solutions, where he served in a series of management positions of increasing responsibility in the US, Europe and globally.With over 25 years’ experience in the field, he began his career with Abbott Laboratories, Diagnostics Division and holds a BA from Lafayette College in Economics and Business.

Jim Murphy, Managing Director, Almac’s Clinical Technologies business unit commented on Mr Tiger’s appointment: “We are pleased to welcome George to Almac. He clearly brings an impressive track record which is especially important to us as we continue to drive global sales and advance our integrated solutions across the Almac Group. With his expertise and level of experience he will prove to be a great asset to the senior management team.”

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Almac Group Appoints Dr. John Robson as VP Quality Operations

admin — Fri, 10 Jul 2015 11:14:25 +0000

Craigavon, UK – 07 Jul 2015 – Almac Group, the global contract development and manufacturing organisation has announced the appointment of Dr. John Robson to the position of Vice President Quality Operations for its Sciences’ Business Unit.

Dr. Robson will be responsible for the operation of their analytical services business and overseeing quality across their sites located throughout the UK and US. In addition to his direct operational responsibilities, he will also be an integral member of the senior leadership team, focusing on strategy development and implementation to expand and grow their global operations.With over 20 years of experience in a number of business leadership, quality and analytical roles Dr. Robson joins Almac directly from Lonza Biologics where he held the position of Global Head of Analytical Services. Prior to this, he served as Vice President and General Manager, Early Development at Covance, and Global Head of Bioanalytical Services at MDS Pharma Services.

Dr. Robson holds a PhD in Analytical Chemistry from the University of Plymouth in addition to a BSc in Environmental Chemistry and also holds an MSc in Organic Geochemistry from Newcastle University.

“John has an impressive track record and will bring a wealth of industry experience to the existing Management team. We are delighted to have him join us.” said Dr. Stephen Barr, Managing Director of Almac’s Sciences business unit.

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Almac Group Announce Companion Diagnostic Partnerships with OncoMed

admin — Fri, 10 Jul 2015 11:11:26 +0000

Craigavon, UK – 22 Jun 2015 – Almac Diagnostic Services today announced that it has entered into an agreement with OncoMed Pharmaceuticals, Inc. (Nassdaq: OMED) to develop a companion diagnostic test to help predict a patient’s likelihood of responding to OncoMed’s novel therapeutic which targets R-Spondin 3 (RSPO3). Anti-RSPO3 (OMP-13R10) has demonstrated activity in preclinical models against a variety of major tumour types, including colon, lung and ovarian cancers.Almac and OncoMed are currently developing a gene expression RSPO3 CLIA assay that can be used to prospectively select patients in the clinical development of anti-RSPO3. OncoMed has filed an Investigational New Drug (IND) application for anti-RSPO3 with the U.S. Food and Drug Administration and a Phase 1a clinical trial is due to commence in summer 2015.“We are very pleased to announce this partnership with OncoMed who we have worked with for many years. This companion diagnostic development program is a significant milestone in our work together and helps Almac achieve its goal of advancing human health globally,” said Professor Paul Harkin, President of Almac’s Diagnostic business unit.“Anti-RSPO3 will be OncoMed’s seventh proprietary candidate to enter clinical testing. In preclinical studies, we see a close correlation between RSPO3 biomarkers and potent anti-tumour activity and we are pleased to collaborate with Almac on the development of a CLIA-validated companion diagnostic assay to support our clinical development efforts.” said John Lewicki, Ph.D., OncoMed’s Chief Scientific Officer.

About OncoMed

OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells (CSCs). OncoMed has six anti-cancer product candidates in clinical development, the most advanced of which are in randomized Phase 2 clinical trials. Demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch2/3, OMP-59R5), brontictuzumab (anti-Notch1, OMP-52M51), anti-DLL4/VEGF bispecific antibody (OMP-305B83), vantictumab (anti-FZD7, OMP-18R5), and ipafricept (FZD8-Fc, OMP-54F28) each target key cancer stem cell signaling pathways including Notch and Wnt. OncoMed recently filed an Investigational New Drug application for anti-RSPO3 (OMP-131R10), an antibody targeting a third key cancer stem cell signaling pathway called R-spondin-LGR. OncoMed is also pursuing discovery of additional novel anti-CSC and cancer immuno-oncology product candidates.OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK). Additional information can be found at the company’s website: www.oncomed.com.

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Almac Group Named UK Trade & Investment Winner in Final of the European Business Awards 2014/5

admin — Fri, 10 Jul 2015 11:01:21 +0000

Craigavon , UK – 27 May 2015 Almac Group was last night named the winner of ‘The UKTI Award for Innovation’ in the final of this year’s European Business Awards, sponsored by RSM, at an exclusive awards ceremony held in London attended by prominent businesses leaders, European ambassadors and political representatives from the EU.The win celebrates the end of a yearlong journey for Almac that began in spring 2014 when the European Business Awards engaged with over 24,000 businesses at the entry stage of the competition. After being named one of 709 National Champions from 33 countries in November, the company took part in the public vote, which generated 174,000 votes, a record-breaking year.

Almac was then announced as one of the 110 Ruban d’Honneur finalists in February and underwent a final face-to-face presentation with a judging panel. Last night they were crowned one of the 11 category winners in front of the best businesses in Europe.

Michael Sloan, VP Business Development, Almac Diagnostic Services, commented on collecting the award: “We are absolutely thrilled to be chosen as one of the top 11 businesses in Europe. This is a major accolade for us as The European Business Awards programme is widely recognised as one of the most challenging competitions in Europe presided over by an esteemed panel of judges.”

Adrian Tripp, CEO of the European Business Awards said: “Our winners are shaping the face of European business and ensuring Europe’s position as a leading player on the global business stage. Huge congratulations to Almac for their success.”

Jean Stephens, CEO of RSM, the 7th largest network of independent audit, tax and advisory firms, said: “The extraordinary entrepreneurialism, innovation and business success demonstrated by this year’s winners shows how much can be achieved in challenging market conditions. They are all a credit to their country and we wish them every success for the future.”

In the 2014/15 competition, all EU member markets were represented plus Turkey, Norway, Switzerland, Serbia, Croatia and the Former Yugoslav Republic of Macedonia, Their combined revenue exceeded €1.5 trillion, and together they generated profits of over 60 billion Euros and employ over 2.5 million people.

The European Business Awards’ primary purpose is to support the development of a stronger and more successful business community throughout Europe. For further information about the European Business Awards and its winners please go to www.businessawardseurope.com.

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Almac Group Appoints Dr. Shirin Khambata Ford as VP Product Development

admin — Tue, 03 Mar 2015 13:58:32 +0000

Durham, N.C., USA, – 2 March 2015 – Almac Group, the global contract development and manufacturingorganization has announced the appointment of Shirin Khambata Ford, PhD to the position of Vice President Product Development for their Diagnostic Services’ Business Unit.

Dr. Ford is a renowned scientific executive with extensive experience in the global pharmaceutical industry having held senior oncology biomarker focused posts in BMS, Roche and Novartis. Until recently, Dr. Ford was the Global Head of Correlative Sciences in Oncology Global Development at Novartis Oncology. She led a group that is focused on developing Oncology Biomarkers and supporting translational research activities for Oncology full development programs. Prior to this Dr. Ford was a Senior Biomarker & Experimental Medicine Leader at Roche Pharma Research & Early Development. Previously she was the Director of Clinical Biomarkers Oncology at Bristol-Myers Squibb where she led a group responsible for the discovery, validation and strategic implementation of pharmacodynamic and predictive markers for the late stage oncology portfolio (Phase I/II through Life Cycle Management).

Her key accomplishments include being the lead researcher on the team that discovered that EGFR ligand gene expression and K-ras mutation status are predictive markers of benefit from cetuximab (anti-EGFR monoclonal antibody therapy) in metastatic colorectal cancer. This work was published in a seminal publication in the Journal of Clinical Oncology and has been validated by her team and others in multiple large retrospective studies. The biomarker research from her group has led to additional publications in journals such as the New England Journal of Medicine, multiple presentations at major international oncology conferences including ASCO, AACR and ESMO meetings and numerous patent applications. As the Biomarker Lead for cetuximab, Dr. Ford was a key participant in regulatory and diagnostic activities in addition to providing scientific leadership and expertise.

“We are delighted to welcome Shirin Ford to the Almac team. We have brought her on board to take over the management of our internal product pipeline. Many of these products are now close to commercialization and her unparalleled experience in the industry will be invaluable as we drive forward these products.” said Professor Paul Harkin, President of Almac’s Diagnostic business unit.

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Almac Group Drives Biocatalysis Leadership with a Further $7M Investment

admin — Thu, 05 Feb 2015 11:48:03 +0000

Craigavon, UK, February 2, 2015 – Almac Group, the global contract development and manufacturing organization, today announced a $7 million investment in a significant collaborative research and development expansion with Queens University Belfast (QUB) supported by Invest Northern Ireland in the area of biocatalyst discovery and development.

The ground-breaking project involves the further development of the Group’s biocatalysis services and will enable the team to build upon their considerable existing expertise.

The 3 year development programme will be in conjunction with QUB to provide new, best-in-class biocatalyst platforms and products for the global active pharmaceutical ingredient, flavour & fragrance, agrochemical and fine chemical sectors.

The investment will establish a unique dedicated biotechnology research team who will accelerate the development of bioinformatics, molecular modelling and enzyme evolution. This will facilitate the introduction of faster and superior methods to access novel enzymes with unique properties that are required for scale-up chemistry.

“The biocatalyst is the future for scale-up chemistry involving chirality as it provides efficient, clean and robust processes. The $7m R&D investment demonstrates Almac’s continued commitment to biocatalysis, supporting further growth in our expertise and capabilities in biotechnology”. Notes Head of Biocatalysis Professor Tom Moody.

Dr Chris Allen, Senior Lecturer in the School of Biological Sciences is Principal Investigator on the grant at QUB. He said: “Biocatalysis and industrial biotechnology are now becoming critical drivers in both the local and global economies. This research project will help to build the knowledge base and expertise in these fields for both Almac Sciences and QUB. The project also demonstrates how different subject areas in QUB – in this case Biological Sciences and Chemistry – can be combined to develop exciting new research opportunities.”

Other academic staff involved are Dr Meilan Huang (School of Chemistry & Chemical Engineering) and Dr Leonid Kulakov (School of Biological Sciences).

Invest NI has offered Almac Group £1.5 million of research and development assistance, this project is part-financed by the European Regional Development Fund under the Investment for Growth and Jobs Programme 2014-2020.

Jeremy Fitch, Invest NI’s Executive Director of Business Solutions said: “This investment in collaborative research and development is good news for Northern Ireland’s growing life sciences sector and will help to strengthen Almac’s expertise in biotechnology.

“Almac has a reputation for excellence in the international pharmaceutical sector and this latest R&D investment will ensure that it remains in a competitive position and can continue to meet the needs of its global client base.”

Stephen Barr, Managing Director, Almac’s Sciences business unit commented: “Today’s announcement is the latest in a series of investments made by Almac over recent years and represents our commitment to building and sustaining an innovative service offering to satisfy growing client demand. We very much look forward to working together with our clients on this exciting project”

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Almac Appoints VP Quality and Regulatory Affairs

admin — Thu, 05 Feb 2015 10:00:56 +0000

Almac’s Diagnostic Services business unit has named Dr Stewart McWilliams as VP Quality and Regulatory Affairs for its global operations.

Stewart will be responsible for regulatory compliance of both client and internal companion diagnostic tests and maintaining quality systems to support these developments. He will also lead the regulatory strategy for Almac’s internal product pipeline.

The move is a promotion for Stewart who has been employed at Almac for over a decade and has gained considerable regulatory experience working at the most senior level with clients to support their Companion Diagnostics regulatory strategies with the FDA, EMA and more recently CFDA.

Professor Paul Harkin, MD Almac’s Diagnostic Services business unit commented “Stewart’s wealth of experience and expertise has been invaluable to our team and this promotion was the natural next step. This new appointment enables us to further develop and successfully drive our strategy for planned future expansion into new markets and we look forward to Stewart’s contribution to our continued growth”.

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Almac Crowned overall Ulster Bank Business Achiever

admin — Mon, 08 Dec 2014 09:30:34 +0000

Craigavon pharmaceutical development company Almac has been crowned overall winner in this year’s Ulster Bank Business Achievers Awards at the final at the Mansion House in Dublin.

It’s the fourth successive time that a Northern Ireland company has won the accolade, this year beating off competition from a record number of entries from across the island of Ireland.

Two other Craigavon headquartered companies also enjoyed success at the national awards final. Avondale Foods was the all-island winner of the Food and Drink Award while Janet McCollum, Chief Executive of Moy Park, won a Judges’ Special Recognition Award for her achievements.

The judges felt that Almac was the stand out company of the finalists noting its state-of-the-art drug discovery, world leading cancer diagnostics, research and development and support of global clinical trials. Employing 3,500 staff worldwide and with a turnover of £350m, the Almac Group was described as “truly a global leader in its field”.

Family owned Avondale Foods, which celebrates its 50th birthday next year is a leading Irish and UK manufacturer of coleslaw, side salads and chilled products, which employs 400. The judges said: “Avondale Foods is a deserving winner of the Food and Drink Award category as they are a well-established company with steady growth which continues to innovate with constant market analysis and serious ambitions to expand further into Europe and beyond.”

Chief Executive of Moy Park Janet McCollum was singled out for her “extraordinary” achievements with a Judges Special Recognition Award. After joining the company in 1993 as European Accountant, she progressed to the Executive Board as Group Finance Director within six years and took up the position of Chief Executive Officer in January 2014.

Ellvena Graham, Head of Ulster Bank Northern Ireland, said:

“The Ulster Bank Business Achievers Awards are a highlight of our calendar in Ulster Bank. It gives us the opportunity to recognise and reward great innovation and also gives us the opportunity to meet exceptionally talented people.

The calibre of entries we have seen this year was excellent, from those across the technology, environmental and service industry sectors to those that promote the island’s world-class agriculture and food industries.

Ulster has traditionally punched above its weight in these awards and it’s great news that Almac is keeping the title of Overall Business Achiever in the region for another year. Congratulations to Almac and also to Avondale Foods and Janet McCollum, of Moy Park on their wonderful achievements.”

Doug Cookson, Vice President Corporate Marketing at Almac Group, says:

“We are delighted to be named Overall Business Achiever in these prestigious awards, particularly when pitched against other outstanding companies across all of Ireland. This is a fantastic recognition of the hard work by all our global teams and dedicated employees, without whom this success would not be possible. Huge congratulations to everyone at Almac on making winning this coveted award possible – it is a true honour for all of us.”

The awards are run in association with Invest Northern Ireland, InterTradeIreland, the Belfast Telegraph and SmallBusinessCan.com.

The companies were judged on a variety of merits including financial performance, company milestones and achievements, future strategy for business people and the business and the development of innovative products and services.

Almac will receive a comprehensive prize package including a £40,000 publishing bursary with the Belfast Telegraph or Irish Independent and business mentoring from Enterprise Ireland.

ENDS

Further information on companies and judges’ comments

Overall Ulster Bank Business Achiever 2014:

Almac Group Ltd

Headquartered in Craigavon, Co. Armagh, Almac is an established contract development and manufacturing organisation providing an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. Services include state-of-the-art drug discovery, world leading cancer diagnostics, research and development, manufacture of active pharmaceutical ingredients, formulation development and the support of global clinical trials.

The judges felt that this company was the stand out company of the finalists. Employing 3,500 and with a turnover £350m, the Almac Group is truly a global leader in its field with local facilities in Souderton and Audubon (Pennsylvania), Durham (North Carolina), San Francisco (California), Singapore and Tokyo. The company has a strong track record of investing in people.

Food & Drink Award:

Avondale Foods

Celebrating its 50th Birthday in 2015, Avondale Foods is the market leading Irish and UK manufacturer of coleslaw, side salads and chilled products. A family owned company, Avondale Foods is located in County Armagh from where its employs 400 people. The judges commented that Avondale Foods are deserving winners of this category as they are a well-established company with steady growth which continues to innovate with constant market analysis and serious ambitions to expand further into Europe and beyond.

Judges Special Recognition Award:

Janet McCollum, Chief Executive, Moy Park

The 2014 Judges Special Recognition Award is being presented by Ulster Bank Business Women Can to recognise the extraordinary achievements of one of the leading businesswomen on the island of Ireland. Having joined the company in 1993 as European Accountant, Janet McCollum progressed to the Executive Board as Group Finance Director within six years. She assumed the position of Chief Executive Officer on 1 January 2014, with leadership of the Moy Park Europe business which covers the UK, Ireland and Continental Europe. Employing some 12,000 people and with a turnover of over £1.2 billion across 14 sites, there are even bigger plans for the future development of the company.

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Almac raises £9,000 for ovarian cancer charity in memory of employee

admin — Wed, 26 Nov 2014 15:06:03 +0000

Almac has raised more than £9,000 for Angels of Hope, an ovarian cancer charity set up in memory of an employee who died from the condition.

Angels of Hope was established in 2003 by Portadown women Maureen Clarke, after the death of her daughter Julie Clarke, at the age of just 27 in October 2002. Julie worked in Almac’s Clinical Services business unit based in Craigavon.

The money was raised through a raffle organised by the company, with prizes donated by local businesses, clients and suppliers. They included business class return tickets to New York, luxury hotel breaks and tickets for concerts and sporting events as well as iPads and LED televisions.

Elaine Gibson, Almac’s Global Travel and Events Manager, organised the raffle and commented on the total: “We’re delighted that we’ve been able to raise so much money for Angels of Hope to support the charity’s work in raising awareness of ovarian cancer and funding research into the disease.

“Staff at our Craigavon headquarters were very keen to help raise funds in Julie’s memory and as Almac is currently carrying out important research into ovarian cancer, as a company we know that awareness and early detection of the disease is vital in order to try to identify appropriate treatment and increase survival rates.”

Earlier this year it was announced that a test devised by scientists at Almac to identify which ovarian cancer patients will react best to chemotherapy is a step closer to being used by doctors after being validated.

Maureen Clarke, from Angels of Hope, said: “Julie’s positive attitude and bravery throughout her illness both amazed and inspired me and it was her intention, when she recovered, to make more women aware of ovarian cancer, but sadly this was not to be. In keeping with her wishes, in May 2003, Angels of Hope was born.

“Angels of Hope relies solely on money raised from events and the generosity of the public who make donations. Without such generosity we would be unable to continue raising awareness or fund research. Without research we cannot hope to find early detection methods or better treatments for ovarian cancer patients. We greatly appreciate Almac’s donation.”

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Almac continues winning streak at Irish Pharma Industry Awards 2014

admin — Wed, 05 Nov 2014 11:01:52 +0000

Craigavon-based pharmaceutical development company Almac has continued its successful run of winning awards after lifting a top title at the 2014 Irish Pharma Industry Awards.

The global company’s Diagnostics business unit won the Research and Development Achievement Award for its work on the company’s proprietary DNA Damage Repair Deficiency (DDRD) test which helps predict which breast cancer patients are likely to benefit from chemotherapy based on their genetic make-up.

Last year the DDRD technology and intellectual property were exclusively licensed to US-company Genomic Health to further develop, validate and subsequently commercialise the test in a multi-million pound deal.

The Irish Pharma Industry Awards are designed to recognise and celebrate the most original and innovative individuals and companies that demonstrate excellence in the Irish Pharma sector. Almac beat off competition from other successful life science and biotech companies, including Aquila Bioscience, Biokinetic Europe and Innopharma Labs to win the R&D award.

Professor Paul Harkin, Managing Director of Almac’s Diagnostics business unit, said: “We are delighted to receive the R&D Achievement award in relation to our highly successful and ground-breaking DDRD test.

“Our developments and expertise in this field have attracted global attention and it is tremendously satisfying when the Irish Pharma Industry Awards judging panel recognised and rewarded our efforts. Huge congratulations to the entire Diagnostics team on winning this award.”

As well as winning two categories in the Aer Lingus Viscount Awards in London, Almac has also been selected as a National Champion in the European Business Awards and was named as the winner of the Best International Business in the Ulster Final of the Ulster Bank Business Achievers Awards. The company now goes forward for all-island judging against provincial winners in the International Business category of the Business Achievers Awards. Winners will be announced on December 4 at a gala event in Dublin.

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Almac’s PATHWAY™ Points Students in Right Direction for STEM Careers

admin — Tue, 21 Oct 2014 14:30:04 +0000

Over 500 students from across Northern Ireland will learn about the merits of pursuing a career in STEM subjects from world renowned scientists at Almac during the company’s Schools Outreach Programme this year.

Pathway™ programme which promotes STEM subjects (Science, Technology, Engineering and Mathematics) as the route to an exciting career was launched at the leading pharmaceutical development firm’s Craigavon headquarters today.

Through the initiative A level and AS level students will take part in tours of the different divisions of the company and meet scientists with varying backgrounds from across the Group, while others will take part in three day work experience placements.

Almac also has strong links with the local universities and each year offer placements to around 60 students on degree and postgraduate courses.

Alan Armstrong, Chairman and CEO of Almac, said: “As one of Northern Ireland’s leading businesses in the life sciences sector, we believe that we have a responsibility to encourage young people here to consider STEM careers which help to grow a dynamic and innovative economy.

“It’s important to us to welcome these students, tell them about what our business does and encourage them to continue studying STEM subjects as they provide an excellent grounding for many careers.”

Stephen Barr, Managing Director of Almac’s Sciences business unit, who oversees the Pathway™ programme, said: “Our STEM Ambassadors play a key role in the success of our Outreach programme. They are Almac employees who are keen to promote STEM subjects and the associated career pathways and they deliver presentations to school groups, facilitate onsite visits and host work experience placements.”

Pupils from the first schools taking part in this year’s outreach programme included those from Lurgan College, Our Lady’s Grammar School in Newry and Shimna Integrated College in Newcastle.

The initiative has been backed by the Department for Employment and Learning. Permanent Secretary of the Department, Derek Baker said: “For the future success of our economy it is vital that we encourage our young people to study STEM courses and educate them about the career opportunities available in the STEM-related industries in Northern Ireland.

“It’s reassuring that a leading, global company like Almac is working with so many young people through its Pathway™ programme to give a valuable insight into what the company does, the interesting jobs that people there perform and the potential routes students can take to pursue successful careers in the sector.”

John Finlay, a chemistry teacher at Lurgan College, said: “We’ve been taking part in Almac’s Schools Outreach Programme for several years and we feel it is a very valuable experience for those studying science subjects.

“We’re keen to provide students with as much career advice as we can in school but seeing the jobs that scientists actually do and having the opportunity to talk to them and tour Almac really helps increase their knowledge about the opportunities that studying science can offer. Several of our students have been inspired to continue their science studies at university level after taking part in the outreach programme.”

The outreach work is part of the company’s CSR strategy which also focuses on charity fundraising and environmental improvement. Over £20,000 has been raised for local charities, including Marie Curie, CLIC Sargent, Autism NI, Southern Area Hospice and Angels of Hope in the last year.

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Almac Introduce Flexible Clinical Trial Direct to Patient Solution

admin — Mon, 20 Oct 2014 08:05:26 +0000

Available for clinical studies conducted throughout the US & Canada

Almac are pleased to announce the launch of their novel “Direct to Patient” shipping service for clinical trials recognising the shift in market trends to introduce as many efficiencies as possible into the management of clinical trials and the supply chain.

The Direct to Patient offering further enhances the existing clinical trial distribution service provided by Almac by co-ordinating all clinical trial (including temperature and non-temperature controlled) material shipments from clinical sites directly to patient’s homes throughout the US and Canada. Due diligence has been performed to ensure adherence with US federal, state and Canadian regulations.

This service offers clinical trial patients enhanced flexibility as it works around their personal convenience and improves the patient experience by reducing on-site clinic visits. In addition patients no longer have to travel to clinical sites for all of their visits thereby reducing associated costs and drop-out rates.

The Direct to Patient service implemented by Almac is in response to increasing sponsor demand and enables trial sponsors to move closer to the patients participating in the trials, regardless of their proximity to study sites.

Donna Christopher, Global VP Operations at Almac commented “Our innovative direct to patient solution offers sponsors a flexible and cost effective approach to conduct their clinical trials which improves patient experience, compliance and efficiency whilst reducing the burden associated with patient retention. We firmly believe this addresses significant challenges currently experienced by our sponsors and Almac are delighted to offer this as part of our established clinical supply solutions.”

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PA Governor Tom Corbett Praises Almac during Visit

admin — Thu, 10 Jul 2014 08:33:41 +0000

The Almac Group were delighted to welcome Governor of Pennsylvania, Tom Corbett to their Souderton based facility on Tuesday 8^th July during which he was given an extensive tour of the state-of-the-art building which included observation of various operations within the production, warehouse and laboratory areas. He also used the opportunity to meet employees and discuss some of the ground-breaking activity being carried out by the Group.

Governor Corbett commented “We’re seeing jobs growing across Pennsylvania and this is just an opportunity to see it here in the middle of Montgomery County.” He praised Almac’s excellence in innovation which has delivered global success for the company and secured a significant number of high value jobs in the Souderton region. He also commended the exceptional financial benefit that Almac contributes to the wider economy which is estimated to be in excess of $20 billion by 2017.

Jim Murphy, President Almac Clinical Technologies Business Unit, commented: “We were delighted to welcome Governor Corbett to our premises here at Souderton so he could see first-hand some of the work carried out by our staff. It is hugely rewarding to be part of a community that recognises the vital importance of sustained economic development and the level of investment that a company like Almac provides.”

The Governor and his staff conveyed their sincere thanks to the entire team for taking time out to host the tour which he found extremely enlightening and he left with a clear understanding of the scale and capability of our operations in addition to our solid Northern Ireland/US links and heritage.

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Almac Launches Recruitment Drive to Fill up to 20 New Positions

admin — Thu, 05 Jun 2014 14:48:31 +0000

Almac is creating up to 20 new positions at its headquarters in Craigavon, most of which will be “high-value” jobs, the company has announced.

The pharmaceutical development company has launched a recruitment campaign, Challenge Yourself, with jobs available ranging from project co-ordinators and project managers to supply chain managers, project leaders and design managers.

Most of the jobs will be based in Almac’s Clinical Business Units, but the company is keen to highlight that candidates do not need to have a scientific background to gain employment.

Almac is holding a recruitment day for project management positions at the Europa Hotel, Belfast, on Wednesday June 18 and staff are keen to meet anyone who thinks they fulfil the requirements for the new jobs.

Dr Kelly Neill, Almac’s Head of Project Services for the UK, commented: “As a global company providing unique services, demand from clients all over the world continues to grow.

“To service that need, we currently have some fantastic opportunities for candidates who are interested in being involved in making a positive difference to human health.

“Working in project management with Almac provides many opportunities for career advancement and those who secure jobs with us face the exciting challenge of working with a dynamic, innovative organisation which offers extremely competitive rewards and benefits.

“We are looking for ambitious people with experience of project management, not necessarily in a scientific area, but there are also vacancies for high calibre graduates.”

Almac provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors including all the world leaders and the company has seen significant growth in the past few years with staff retention rates remaining high.

It now employs over 3,300 staff across its operations in Craigavon, the US – in Pennsylvania, North Carolina and California and its recently opened hubs in Singapore and Japan.

Almac recently announced record pre-tax profits of £19.2m in 2013, up around 30% on the previous year.

The company also saw turnover increase, up by 8% from £300m to £325m.

Almac’s Recruitment day takes place at the Europa Hotel in Belfast on Wednesday 18 June from 8:00am to 8:00pm. To register your interest in the event or to find out more information contact recruit@almacgroup.com or visit almacgroup.com/careers.

The company will also be one of the exhibitors at the Northern Ireland Graduate Recruitment Fair on Tuesday 10 June from 11am to 3pm in the Assembly Hall, University of Ulster, Jordanstown.

ENDS

Notes to Editors

About Almac Group

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

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Almac validates novel test for Ovarian Cancer patients

admin — Mon, 02 Jun 2014 07:19:42 +0000

AADx gene expression biomarker identifies a molecular subgroup of ovarian cancer patients that has better survival following standard chemotherapy but may be disadvantaged by bevacizumab.

CRAIGAVON, UK – Almac Group Ltd.’s Diagnostics Business Unit today announced the validated results of the ALM AADx assay, a gene expression test that identifies a subgroup of high grade serous ovarian cancer (HGSOC) patients that have a good prognosis following standard of care chemotherapy.

Significantly this good prognosis subgroup exhibited worse progression free and overall survival following the addition of bevacizumab within the ICON7 translational dataset. Patients whose tumours fell outside of this molecular subgroup exhibited a trend towards improved progression free survival.

The molecular subgroup identified by this test is defined by absence of angiogenesis and represents 40% of the HGSOC population. The molecular subgroup was identified by Almac in collaboration with Professor Charlie Gourley from the University of Edinburgh and was initially reported at ASCO 2011. The current work represents an independent validation of the assay and was carried out in collaboration with the Medical Research Council in the UK.

Unsupervised hierarchical clustering by Almac found three molecular subgroups within HGSOC; one with angiogenic gene inactivation and immune gene upregulation (‘termed the immune’ subgroup ) with better overall survival rates; and two with angiogenic gene upregulation and a corresponding worse overall survival rate following standard of care first line chemotherapy.

These latest validation results were presented at the 2014 ASCO Annual Meeting in Chicago by Professor Gourley.

Almac developed a 63 gene test that can prospectively identify the good prognosis angiogenesis inactive subgroup and independently validated the test within the ICON7 translational data set.

Almac is now seeking to perform additional validation studies of the test in HGSOC as well as in other cancer types. Almac believes that the test will also work for other anti-angiogenic compounds that function in a similar manner as well as for other diseases and has now engaged with the FDA & European Regulatory Authorities to bring this novel assay to market in 2015.

Prof Richard Kennedy, Almac & Queen’s University Belfast, stated, “This assay may help clinicians discuss the likely benefit from standard carboplatin and paclitaxel based chemotherapy with their patients and could inform discussions on other potential approaches to treatment for those with a predicted worse outcome”.

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Almac sees profits increase by 30% as company enjoys record year

admin — Tue, 27 May 2014 08:07:10 +0000

Craigavon-based pharmaceutical development company Almac recorded pre-tax profits of £19.2m in 2013, up around 30% on the previous year, it has announced.

The company also saw turnover increase, up by 8% from £300m to £325m.

Around 3,300 people now work for Almac globally, with over 2,000 based at their Craigavon Headquarter site.

The company has a major US operation in Pennsylvania and recently opened regional hubs in Singapore and Japan to help service increasing demand for its services in the Asian market.

Alan Armstrong, CEO of Almac, said: “Our long term objective is to be the leader in our chosen markets and following another successful year I’m pleased to report that we are showing sustained progress in reaching this goal.

“2013 was an exciting year for us with a major jobs boost in Craigavon as we completed a non-GMP drug development facility and expanded our manufacturing capabilities, announced a £13m investment in cancer research projects with Queen’s University and signed a $9m deal with Genomic Health securing the rights to further develop and commericalise our breast cancer test.

“We have continued to invest in research and development and capital programmes and this year is set to be another successful one both at our headquarters in Craigavon and globally, following the opening of our new offices in Asia, and looking ahead to the launch of our new facility in Singapore early next year.”

Almac will open a new clinical trial secondary packaging facility in Singapore at the start of next year to better enable just-in-time supply management and support drug pooling strategies, which further optimise the supply chain, minimise wastage and reduce costs.

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Almac flies high at Aer Lingus Viscount Awards

admin — Thu, 01 May 2014 09:00:00 +0000

Presented with Best Large Business and Overall Excellence Awards

Almac has been awarded with both the Best Large Business and Overall Excellence category awards at the 6^th annual Aer Lingus Viscount Awards in London.

Run in association with Ulster Business Magazine, the awards are designed to honour companies which have forged vital economic ties between Northern Ireland and Great Britain as well as recognising Northern Ireland’s best businesses across a wide spectrum of specialist areas.

The Best Large Business award recognised Almac as the most entrepreneurial large company, excelling in all functions of business by demonstrating significant commitment to producing and marketing its products and services and contributing to the NI/GB commercial relationship.

The award for Overall Excellence was presented to Almac in recognition of the company’s positive contribution and impact on the Northern Ireland economy, strong commercial performance, business growth and innovation in addition to its commitment to export excellence.

Both awards were presented to Almac’s VP Corporate Marketing, Doug Cookson, during an awards luncheon at the Royal Automobile Club in London.

As part of the award ceremony Dr Laura Hill, Almac’s Team Leader Clinical Bioinformatics, participated in a panel session alongside other Northern Ireland business leaders and award judges. Dr Hill discussed Almac’s remarkable progress over the past 12 months and explained how its continual innovation has enabled the company to achieve sustainable growth.

Doug Cookson, VP Corporate Marketing at the Almac Group, said: “We are delighted to have won two prestigious Aer Lingus Viscount Awards. It’s great to be acknowledged for the pioneering work our teams across the globe undertake and we’re proud to be recognised among the best of Northern Irish businesses.

“Our heart is very much based in Northern Ireland but our reach is truly global.

“Some of our notable achievements in the last year include significantly increasing our turnover to £300m, the development of a novel, state of the art, diagnostic test to assist in the treatment of breast cancer and enhancing our existing presence in Asia by starting the development of a new facility in Singapore and opening offices in Japan to further expand support for our customers.”

The awards come just one month after Almac picked up two category awards at the Belfast Telegraph Business Awards for Excellence in Innovation and Excellence in Technology in addition to being recognised at The Irish Laboratory Awards by winning “Laboratory Team of the Year” in December.

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Almac Achieves Double Success at Business Award Ceremony

admin — Fri, 28 Mar 2014 16:09:16 +0000

Almac are delighted to announce the exceptional achievement of picking up two category awards at last night’s prestigious Belfast Telegraph Business Award gala ceremony in association with British Airways. The awards are in their 12th year and are the premier symbol in Northern Ireland of commercial, industrial and social enterprise achievements.

The winning “Excellence in Innovation” entry focussed on the development of our Antibody Drug Conjugation (ADC) offering provided by the Science’s biocatalysis group headed up by Professor Tom Moody. Almac has developed the innovative ADC science from the laboratory bench into successful, novel, commercial offerings that are now part of their existing business portfolio.

The trophy was presented by Kevin Traynor, Belfast Telegraph’s Digital Director to Dr William Watters, Isotope Chemistry Manager at Almac’s Sciences Business Unit (pictured above). The other 2 finalists in this category were Core Systems and Randox Laboratories.

The “Excellence in Technology” award recognised the advances made by the Diagnostics team in relation to the recently announced DNA Damage Repair Deficiency (DDRD) research. This new technology offers significant advances in the treatment of cancer and has recently been the subject of a collaboration with US-based Genomic Health Inc to bring its benefits to patients worldwide.

The trophy was collected by Michael Sloan, VP Business Development for the Diagnostics Business Unit from Karen Blair, MD, Cleaver Fulton Rankin who sponsored the award. Other finalists in this category were PathXL and Taggled Ltd.

Alan Armstrong, CEO, Almac Group commented on receiving the honours: “We are delighted to receive these prestigious awards and is a tremendous tribute to the pioneering work carried out on a daily basis by our dedicated and talented teams here at Almac. It is especially pleasing to achieve recognition for our work within the context of such strong local competition and is testimony to the true innovation and technology that we pride ourselves on within the pharmaceutical and biotech industry.”

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Almac Expands Asia Pacific Operations, Establishes Regional Operations Center in Singapore

admin — Tue, 11 Mar 2014 08:16:29 +0000

Comprehensive support for trials of any size or complexity whether they originate in Asia or include Asian sites

Craigavon, UK – Almac today announced the expansion of its clinical services and technologies capabilities to include on-the-ground leadership as well as technical, project and operational resources in Asia. The company has established regional hubs in Singapore and Japan to better enable the industry’s growing need to conduct clinical trials in Asia and/or manage global trials from the region. Local teams apply insights gained from Almac’s experience managing more than 10,000 trials around the world to design, implement and manage drug supply strategies and efficient technology solutions throughout the life of the study.

“From protocol to patient to kit destruction, Almac delivers high quality, flexible and cost-effective solutions that enable a more comprehensive approach to trial supply management,” says Alan Armstrong, CEO, Almac. “No one else can provide the global scale, scope and reach required to optimize sponsors’ R&D investments across every facet of the supply chain — within Asia or around the world.”

Providing expert and responsive service is essential for all trials, but particularly those managed from or within Asia. Sponsors must be able to navigate technical, logistical and clinical complexities from trial start-up through to supply and patient management. Almac’s local teams support studies of all sizes and degrees of complexity, helping sponsors to achieve time-saving efficiencies, reduce costs and improve trial outcomes. Services are augmented by a secure, web-based interface to monitor trial execution anywhere in the world, multi-lingual technical and project teams, and an in-house 24 x 7 x 365 hotline connecting site staff to on-call clinicians and unblinding specialists. By positioning operational resources within the same time zones as where trials are executed, Almac is able to resolve issues in less than 24 hours — which in turn eliminates communications delays and improves patient care.

Almac is strengthening its Asia Pacific offerings by establishing a new secondary packaging facility in Singapore that will open by the end of 2014. Through this facility, the company will better enable just-in-time supply management and support drug pooling strategies, which further optimize the supply chain, minimize wastage and reduce costs.

“With 15 percent of all clinical trials conducted in Asia, it’s imperative that we provide localized service and support to our clients,” continues Armstrong. “We’ve long managed clinical trials on a global basis, but there’s now sufficient critical mass that requires we establish dedicated resources in the region. I’m pleased that our international expertise and global capabilities are now even more accessible to sponsors in this critically-important part of the world, and look forward to opening our new packaging facility later this year.”

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Data Presented Supporting Almac Developed Colon Signature as a Significant Predictor of Risk of Recurrence in Stage II Colon Cancer

admin — Tue, 28 Jan 2014 10:59:55 +0000

Almac’s Diagnostic Services business unit today announced the presentation of an external validation of their ColDx signature for stage II colon cancer recurrence. Following publication of the initial validation study in the Journal of Clinical Oncology (JCO) in November 2011, Almac subsequently out-licensed the test to Precision Therapeutics, Inc. for further independent validation and commercialisation in the USA.

The study performed by Precision Therapeutics in conjunction with the Alliance for Clinical Trials in Oncology (Alliance) comprised of investigators from renowned institutions such as Duke University, Dana-Farber Cancer Institute, University of Chicago, Brigham and Women’s Hospital, among others, demonstrates that the ColDx assay is a significant, independent predictor of recurrence-free interval (RFI) in stage II colon cancer. Findings were presented at the 2014 Gastrointestinal Cancers Symposium (ASCO-GI) held January 16-18^th, in San Francisco, California.

This large, independent clinical validation study utilised data and samples from 393 stage II colon cancer patients enrolled in the phase III CALGB (Alliance) 9581 clinical trial to assess the ability of the prognostic, 634-probe gene expression signature (ColDx) to improve upon current methods of differentiating patients as higher versus lower risk of recurrence within five years post-surgery. The signature remained significant after adjustment for conventional prognostic risk factors (hazard ratio = 2.1; 95% CI, 1.3-3.4; p < 0.01), including micro-satellite instability (MSI), T-stage and number of nodes examined. These findings confirm the previous independent validation results published in the Journal of Clinical Oncology in 2011 (Kennedy, et al.). The ColDx assay will be marketed by Precision Therapeutics, Inc. under the name GeneFx^® Colon in the United States.

“We are delighted that the ColDx assay has, once again, been validated as a prognostic biomarker for early stage colon cancer” says Richard Kennedy, MD, PhD, McClay Professor in Medical Oncology, Queens University Belfast and VP and Medical Director, Almac Diagnostic Services. “We believe this assay has the potential to help clinicians personalise the treatment of this disease and look forward to its full commercial launch this year by Precision Therapeutics.”

About GeneFx^® Colon

GeneFx^® Colon is a microarray-based gene signature developed for FFPE tissue from stage II colon cancer patients. GeneFx^® Colon is performed on a small amount of tissue, removed during surgery and identifies patients at higher risk of recurrence within 5 years following initial surgery. GeneFx^® Colon is expected to provide better-informed and more personalised treatment decisions for the physicians and patients facing this disease.

About The Alliance for Clinical Trials in Oncology

The Alliance for Clinical Trials in Oncology is a national clinical trials network sponsored by the National Cancer Institute that consists of a network of nearly 10,000 cancer specialists at hospitals, medical centers, and community sites across the country and Canada. The Alliance is dedicated to developing and conducting clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as researching methods to alleviate side effects of cancer and cancer treatments.

About Almac Group

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

Almac Diagnostic Services is a division of Almac Group Ltd focusing on the discovery, development and delivery of novel prognostic and predictive tests.

Almac Diagnostic Services has a pipeline of oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

In addition Almac Diagnostic Services partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics.

Visit almacgroup.com, e-mail info@almacgroup.com

About Precision Therapeutics

Precision Therapeutics, a leading life-science company based in Pittsburgh, Pennsylvania, is dedicated to personalising cancer care and improving patient outcomes. Precision offers a portfolio of products developed to help guide physicians with difficult clinical decisions throughout the cancer care continuum.

In addition to GeneFx Colon, Precision’s leading personalised medicine products include:

ChemoFx^®, a proprietary drug response marker which categorises an individual patient’s tumor response to a range of standard chemotherapeutic options. Recently published data demonstrates a 14-month improvement in overall survival (OS) when recurrent ovarian cancer patients are treated with ‘responsive’ therapies as indicated by ChemoFx^®.
BioSpeciFx^®, a portfolio of clinically relevant molecular tests that provide information about drug response and patient prognosis.
Precision also offers the microRNA-based Rosetta Genomics Cancer Origin Test^®, which identifies 42 tumor origins with overall specificity up to 99% and overall sensitivity up to 85%.

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Almac publishes breast cancer chemotherapy response assay in the Journal of the National Cancer Institute

admin — Tue, 21 Jan 2014 09:10:23 +0000

Almac’s Diagnostic Services business unit today announced the publication of its breast cancer chemotherapy response assay in the Journal of the National Cancer Institute (JNCI).

The article entitled “Identification and Validation of an Anthracycline/Cyclophosphamide– Based Chemotherapy Response Assay in Breast Cancer” led by Almac’s Medical Director, Professor Richard Kennedy gives detail on the development and initial validation of a predictive gene signature for chemotherapy response in breast cancer.

Breast Cancer is the world’s most common cancer among women with one in eight diagnosed in their lifetime. Although modern chemotherapy reduces the risk of recurrence for some patients, not everyone benefits. At present there is no means of identifying those patients who will and will not respond to first line therapy. Almac’s objective in the development of this assay was to provide a means of identifying those breast cancer patients more likely to respond to standard of care chemotherapy treatment.

The assay was developed by Almac in collaboration with Queens University Belfast and the Mayo Clinic, Rochester, USA. Almac carried out microarray analysis of patient samples and identified a molecular subgroup with a deficiency in DNA damage repair, termed DDRD for DNA Damage Repair Deficient. Almac then developed a 44 gene classifier capable of prospectively identifying this molecular group in patient tumour samples.

The DDRD signature was then initially validated in a neo-adjuvant breast cancer cohort. In the neo-adjuvant setting the assay predicted complete pathologic response with an odds ratio of 3.96, meaning those patients that were DDRD positive were almost four times more likely to respond to treatment compared to patients that were DDRD negative. In the adjuvant setting, a DDRD positive result predicted 5 year relapse free survival with a Hazard Ratio 0.37 compared with test negative patients.

“The publication of this data represents a significant milestone for Almac as we transition this assay into the clinic. The publication of these results combined with our recent out-licensing of the assay to Genomic Health for use in breast cancer patients, highlights the quality of the science being carried out here in Almac” said Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Services business unit.

The test has been developed and validated exclusively using formalin fixed paraffin embedded (FFPE) tissue using Almac’s own proprietary Breast Cancer DSA®.

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Almac wins Laboratory Team of the Year at The Irish Laboratory Awards 2013

admin — Tue, 10 Dec 2013 09:44:12 +0000

Almac‘s Enzyme Research and Development team have been recognised at The Irish Laboratory Awards by winning “Laboratory Team of the Year.”

The awards, the first of their kind in Ireland, were held to recognise the success and achievements of Ireland’s internationally renowned scientists in areas including innovation, leadership and collaboration, and focus on the on-going work of Irish scientists to grow and develop sustainable, globally competitive science research.

The 30-strong Almac Biocatalysis Team has been at the forefront of innovation and solutions to a large number of Pharmaceutical companies and API manufacturers across the world. Enzymatic technology is increasingly displacing chemical processes, yielding a higher quality product at a more attractive price while making significant benefit to the environment.

Tom Moody, Head of Biocatalysis and Isotope Chemistry at Almac commented, “Our team is recognised globally as a key player in the area of biocatalyst research and development and we are delighted to have won this award.”

“It is now acknowledged that the need for green, economic, robust and scalable processes is at the forefront of customer research plans for the synthesis of chiral APIs and intermediates. This award demonstrates our continued success in this field, and the Enzyme Research and Development team is a key to our future.”

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Genomic Health and Almac Group Enter Exclusive In-Licensing Agreement to Develop and Commercialize Anthracycline Chemotherapy Benefit Test for High Risk Breast Cancer

admin — Tue, 26 Nov 2013 08:40:25 +0000

REDWOOD CITY, Calif., and (CRAIGAVON, UK) Nov. 25, 2013 — Genomic Health, Inc. (Nasdaq: GHDX) and ALMAC GROUP Ltd jointly announced today that Genomic Health will exclusively license Almac Group’s technology and intellectual property to further develop, validate and subsequently commercialise a multi-gene test to predict benefit from DNA damage-based chemotherapy drugs, such as the commonly used anthracycline-based regimens, in breast cancer. Such a test would be particularly useful for high-risk breast cancer patients who are eligible for chemotherapy based on their Oncotype DX® score.

Genomic Health will identify a study cohort for the validation of Almac’s previously identified and published genes. Genomic Health made an up-front payment of $9 million dollars, which the company expects to expense in the fourth quarter of 2013, and will pay additional milestones as certain clinical and commercial endpoints are achieved in the future. Upon successful commercialisation of the test, Genomic Health will pay additional royalties to Almac Group.

“Working with Almac, we have the opportunity to gain further insight on the role of DNA repair in drug efficacy, which may provide clinical utility to help select which breast cancer patients benefit from specific chemotherapy drugs and regimens,” said Steven Shak, M.D., Executive Vice President of Research and Development of Genomic Health. “Over the past ten years Oncotype DX has played a critical role in predicting benefit of chemotherapy, in general, for more than 400,000 estrogen-receptor positive breast cancer patients. This new test may address another unmet need by providing additional information specific to the benefit from anthracycline-based regimens for high-risk patients and possibly those with triple negative breast cancer as well.”

Anthracycline-based chemotherapy regimens are commonly used to treat breast cancer, but have significant toxicities that can be debilitating and impact long-term quality of life. Currently, the decision to use these therapies is based on conventional clinical and pathologic factors including age, tumor grade, tumor size and patient comorbidities. However, none of these factors accurately determine which patients will benefit from anthracycline-containing regimens.

“As developers of novel prognostic and predictive tests, we are very pleased to partner with Genomic Health and look forward to leveraging their rigorous clinical validation approach and commercial expertise to advance our development work to reach patients,” said Paul Harkin, President and Managing Director of Almac Diagnostic Services. “We see tests such as this having a significant impact on accelerating personalised healthcare thereby improving the clinical management of cancer patients.”

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient’s journey, from screening and surveillance, through diagnosis, treatment selection and monitoring. Genomic Health’s lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS). In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of September 30, 2013, more than 19,000 physicians in over 70 countries had ordered nearly 400,000 Oncotype DX tests. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organization that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

Almac Diagnostic Services is a division of Almac Group Ltd focusing on the discovery, development and delivery of novel prognostic and predictive tests.

Almac Diagnostic Services has a pipeline of oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

In addition Almac Diagnostic Services partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics.

Visit almacgroup.com, e-mail info@almacgroup.com

Torreya Partners LLC advised Almac Group Ltd in this transaction

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to our plans to develop and validate a test for prediction of benefit from DNA damage-based regimens including Anthracycline for High Risk Breast Cancer; the expectation that the initial study results of the Almac group will be confirmed in further studies; our plans to commercially launch an Oncotype DX test for DNA damage-based regimens including Anthracycline Benefit Assay for High Risk Breast Cancer; the potential indications for use of a test; the ability of any such test to individualize cancer treatment decisions ; the potential of the test to change medical practice for high risk breast cancer patients ; the ability of the company to develop additional tests in the future; the scope, success or results of clinical trials and the timing of such activities; the ability to meet clinical and commercial endpoints; the timing and amount of any future milestone or royalty payments; the applicability of clinical study results to actual outcomes; the ability of the company to obtain and maintain adequate reimbursement for the test; our beliefs regarding the attributes of our product pipeline; and our ability to develop additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, the results of clinical studies; the applicability of clinical study results to actual outcomes; the risks and potential delays associated with such studies; the risks, costs and potential delays associated with the commercialization of current and future products; unanticipated costs or delays in research and development efforts; risks and uncertainties associated with the regulation of and reimbursement for our tests, both domestically and abroad; our ability to compete against third parties; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

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Almac Further Enhance 3rd Party Logistics Commercial Support Services for Niche / Orphan Drugs

admin — Mon, 18 Nov 2013 09:18:24 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, is pleased to announce the release of an enhanced 3rd Party Logistics (3PL) Customer Billing Application.

In response to growing client demand for fully integrated end to end support of EU product launches, from import testing, country specific packaging, QP release, online ordering, direct to pharmacy distribution and financial services, Almac have enhanced their customer billing software to facilitate a seamless invoicing process on behalf of 3PL clients.

3PL orders, received directly from hospitals / clinics / pharmacies, for niche/ orphan drug products, will now be processed, dispatched, and automatically invoiced on the client’s behalf. The process will be completed by reconciliation of payments to the client’s EU account, as well as debtor follow up.

David Downey, VP Commercial Operations of Almac explains “With our client partners, we have successfully launched many high-value, orphan drug / niche products into the European market. With this enhancement to our customer billing application, we can alleviate the client’s administrative burden, by essentially becoming an extension of their supply chain team and assist in managing cash receipts and debtor follow up. Particularly for US based clients with no EU operational footprint, this end to end service provides a compelling business case to partner with an experienced EU solutions provider. ”

About Almac

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

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Almac’s Strengthened Facilities Accommodates Demand of Late Stage API Manufacture

admin — Wed, 13 Nov 2013 11:04:06 +0000

Almac is pleased to report that the expansion of its API manufacturing facilities has allowed significant growth in its late stage manufacturing service.

The facility upgrade included installation of two 1,000L reactors and state-of-the-art pressure filter dryer, which now allows production of highly potent API manufacture up to 500kg with a dedicated nitrogen jet mill for micronisation.

Denis Geffroy, VP Business Development, commented: “Over the past few years, Almac’s API business has continued to grow at a double digit pace. The facility expansion was much needed and the results are already striking with several Phase III and Commercial projects awarded.”

Almac’s clients also leverage Almac’s API and Drug Product integrated offering where API manufacture and finished drug production is carried out on the same site, ensuring reduction in costs and timelines whilst maintaining scientific continuity. This year Almac has completed its first joint commercial API and Drug Product manufacture which demonstrated the advantages of integrated operations.

“Today, our API business is made of 30% late phase and commercial projects, compared to just 5% 3 years ago, which gives a clear indication that our strategy to invest through expansion was the right one.” added Denis.

Notes to Editors

About Almac

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

To learn more about Almac please visit almacgroup.com, e-mail info@almacgroup.com or follow us on Twitter at https://twitter.com/AlmacGroup.

The post Almac’s Strengthened Facilities Accommodates Demand of Late Stage API Manufacture appeared first on Almac.

Almac Increase Global Stability Storage Capacity

admin — Tue, 05 Nov 2013 09:15:12 +0000

Almac have completed a $2m investment programme which doubles its global API and drug product stability storage capacity in line with its growth forecast.

Almac’s new storage capacity at both its European headquarters in Craigavon, UK, and at its USA headquarters in Souderton, PA enable conditions of 25°C / 60% RH, 30°C / 65% RH, 30°C / 75% RH, 40°C / 75% RH, 5°C, -20°C to be offered. All conditions are ICH compliant, continually monitored, and supported with back-up systems ensuring a totally secure and controlled environment.

Within its Analytical Services unit, ICH method development, validation, dissolution and release testing are also offered. This capability enables physical and chemical stability studies to be conducted on both API and a diverse range of drug products, including DEA controlled substances.

Rick Dyer, VP Quality Operations, commented, “With over 150 live stability programmes being managed at any one time, this is a welcome investment and enhancement to our facilities in both UK and USA. Coupled with the recent completion of our API manufacturing facility, Almac are well placed to support the development and regulatory approval of our clients’ drug development programmes.”

Aeri Park, Director of USA Operations, added, “The brand new stability chambers are of the highest quality standards to continue offering excellent reliability and increased efficiency for our clients looking to outsource stand alone stability studies, or in an integrated fashion, with Almac’s clinical trial supply services.”

Almac can provide stability studies from a single batch to multiple batches / packaging materials for both drug substance and drug product; from non-GMP compliance to pivotal registration / commercial studies.

Find out more about this exciting announcement and other developments by visiting Almac at AAPS, stand 4128.

About Almac

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

To learn more about Almac please visit almacgroup.com, e-mail info@almacgroup.com or follow us on Twitter at https://twitter.com/AlmacGroup.

The post Almac Increase Global Stability Storage Capacity appeared first on Almac.

Richard Segiel, Jr. Joins Almac as Vice President of US Business Development

admin — Tue, 29 Oct 2013 09:21:27 +0000

Almac’s Clinical Services Business Unit is delighted to announce that Richard Segiel, Jr. has joined the company as Vice President of Business Development for the United States. He brings with him 23 successful years of experience in the contract pharmaceutical development sector. In his new role, he will focus on developing new business, maintaining existing business, and developing partnerships.

Prior to joining Almac, Richard held a number of Business Development and Operational positions at Intertek Pharmaceutical Services, MDS Tricon, Celsis Analytical Services, and Pharmakon Research International.

“Richard brings a compelling mix of business development, operational, and financial experience that will further strengthen Almac’s leadership team. This skill set is key to delivering on our core objective of enhancing our US client relationships, further developing our commitment to customer service, and helping achieve true strategic partnerships,” said Martin Lamb, Global VP of Business Development.

Most recently, Richard served as Business Development Director of Intertek Pharmaceutical Services where he had direct responsibility for all Business Development and Sales initiatives for the company’s Chemical and Pharmaceutical Division NA.

As Vice President, Business Development at Celsis Analytical Services, Richard assembled the sales and client services divisions, which achieved record sales performance for six consecutive years under his supervision. Additionally, Richard implemented many sales infrastructure programs including the organization’s first CRM system, new KPI metrics, as well as successful sales compensation plans.

“We are very pleased to have Richard on our growing Business Development team. Richard’s experience in the contract pharmaceutical development sector coupled with his proven ability to develop, build, and manage a world-class sales force will make him a vital asset to our team,” says Robert Dunlop, President of Almac’s Clinical Services Business Unit. “Our goal was to find a proven leader who could help us grow our business in the US, and Richard is the perfect fit.”

Richard holds a bachelor’s degree in Chemistry and Business from the University of Scranton and an MBA in Marketing and Finance. Richard lives in Gouldsboro, Pennsylvania with his wife Kimarie and their two children.

About Almac

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

To learn more about Almac please visit almacgroup.com, e-mail info@almacgroup.com or follow us on Twitter at https://twitter.com/AlmacGroup.

The post Richard Segiel, Jr. Joins Almac as Vice President of US Business Development appeared first on Almac.

Almac invests to accelerate formulation development services

admin — Wed, 23 Oct 2013 09:09:11 +0000

In Jan 2013, Almac completed the doubling of their pharmaceutical development service capabilities with the opening of a new dedicated Non-GMP facility together with 2 analytical laboratories at their UK headquarters.

Although the new facility is dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs.

In parallel to the new non-GMP facility, Almac has doubled its analytical capacity with new analytical laboratories for processing the large sample sets which result from non-GMP process development work for clients who seek to better understand their processes in line with the principles of QbD.

Additionally, in response to increased client demand for preclinical and early phase clinical GMP supply, Almac have further enhanced their pharmaceutical development offering with an investment in additional Xcelodose® technology. Similar to our existing Xcelodose technology this additional Xcelodose unit comes complete with an Xcelohood providing the capability to dose potent API directly into capsules.

“Almac is continually assessing and investing in solutions to accelerate the manufacturing of our client’s clinical supplies, while ensuring quality at all times. The investments this year in the new non-GMP facility and Xcelodose equipment strengthens Almac’s position as an integrated service provider in the pharmaceutical development sector.” said John McQuaid, VP Technical Operations.

For further information on our Pharmaceutical development services, please visit us at booth # 42L08.

The post Almac invests to accelerate formulation development services appeared first on Almac.

Almac expands US & UK commercial facilities

admin — Tue, 22 Oct 2013 12:52:13 +0000

Investments of over $20m enhance Almac’s commercial facilities on both sides of the Atlantic

With the opening of a new commercial packaging facility in the US and enhanced processing capabilities at the company’s Headquarters in Craigavon, UK, investments in the past year has substantially transformed the commercial business unit of Almac.

In Feb 2013, with FDA approval, Almac opened their US commercial packaging facility providing quality driven, flexible packaging solutions for both solid oral dosage forms and biopharmaceutical products.

Meanwhile, expansion continued at Almac’s UK commercial manufacturing and packaging facilities, with the completion of a US client led capital project in support of a key global product launch. This expansion has added significant capacity for commercial fluid bed drying and high speed encapsulation.

Additionally, in response to growing demand from a number of Japanese partners for enhanced flexibility related to larger blister sizes and requirement for non permeability and environmental protection, investment has also been made in state of the art blistering technology with product humidity control.

Due to record sales, growth in one of Almac’s client’s key products and entry into new markets including China, the most recent commercial expansion completed at the UK site was a client led second investment in dedicated facilities, doubling sachet output to 250 million sachets per annum.

David Downey, VP, Commercial Operations notes: “Almac continues to grow in partnership with our clients and is developing a strong reputation for the delivery of complex, time sensitive capital projects in support of growing, innovative products. This level of commercial investment demonstrates our commitment to building long term, strategic relationships.”

For further information on our commercial services, please visit us at CPhI booth # 42L08.

-End-

Notes to Editors

About Almac

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

To learn more about Almac please visit almacgroup.com, e-mail info@almacgroup.com or follow us on Twitter at https://twitter.com/AlmacGroup.

The post Almac expands US & UK commercial facilities appeared first on Almac.

Novozymes Biopharma announces collaboration with Almac in Drug Manufacture, Half Life Extension and Targeting Technologies

admin — Tue, 22 Oct 2013 08:07:04 +0000

Combined service offers drug development companies efficiencies in time and resource

Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, is delighted to announce its new collaboration with Almac, to provide a combined service for drug development applications in the field of drug targeting and pharmacokinetic improvements. The collaboration will allow clients to utilise Almac’s world-class manufacturing assets and protein conjugation capability to link Novozymes’ Recombumin® Flex technology successfully to their peptide and small molecule drugs. This subsequently improves the pharmacokinetics and has already been shown to improve drug targeting in oncology and rheumatoid arthritis. Collaborations with commercial partners have already begun and will continue to expand in early 2014.

Novozymes and Almac have a solid history of cooperation in peptide and small molecule conjugation projects. The formalisation of this collaboration offers drug developers the immediate benefit of continuity of service provision through the stages of clinical development -delivering efficiencies in time and internal resource, whilst increasing the chances of clinical success. Clients will also benefit from extensive experience in product and service provision to the pharmaceutical industry with access to a comprehensive level of both technical and regulatory support.

Novozymes’ Recombumin® Flex technology will be the focal point of this collaboration. Novozymes has modified the amino acid sequence of human albumin to increase its receptor affinity, providing novel properties including improved half-life extension and drug targeting. This technology naturally complements Almac’s expertise in peptide and small molecule manufacturing, and can also be allied to its world-class protein conjugation technology offerings. As a result, clients will be able to successfully use Almac’s technology to link Recombumin® Flex to their drug products as part of one contract service offering.

“By working alongside Almac, we are confident that we will be able to create more opportunities for developers seeking to benefit from the Recombumin® Flex technology.” stated Dermot Pearson, Marketing Director at Novozymes Biopharma. “The advantage of working with two companies well versed in providing products and services to the pharmaceutical industry is that customers gain the assurance that their needs will be provided for, not just in the short term, but right through to commercial supply.”

Denis Geffroy, VP Business Development for Almac stated: “This alliance has clear benefits for companies involved in both drug development and delivery technologies: a complete service can be recommended utilising the core expertise of both parties at an early stage of clinical development, thus significantly enhancing the success of drug development programmes.”

Both Almac and Novozymes Biopharma will be exhibiting at CPhI WorldWide: Almac in Hall 4.2 L08, and Novozymes Hall 6.2 62E47.

About Novozymes

Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries, we create tomorrow’s industrial biosolutions, improving our customers’ business and the use of our planet’s resources.

With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace. Read more at www.novozymes.com.

Contact:

Novozymes Biopharma:

Sally Vernon, Marketing Communications Manager

Email:SYKE@novozymes.com>

Tel. +44 115 955 3355

MEDIA CONTACTS

INVESTOR CONTACTS

Europe René Tronborg

Office: +45 4446 2274

Mobile: +45 3077 2274

retr@novozymes.com

USPaige Donnelly

Office: +1 919 494 3209

Mobile: +1 919 218 4501

pagd@novozymes.com

ChinaZhu Xiaoqing

Office: +86 106 298 7888+362

Mobile: +86 138 012 40590

xqzh@novozymes.com

BrazilAna Cecilia Amarante de Oliveira

Office: +55 41 3641 1096

Mobile: +55 41 9619 7594

aaov@novozymes.com

USThomas Steenbech Bomhoff

Mobile: +1 919 649 2565

tsbm@novozymes.com

About Almac

‘Partnering to Advance Human Health’

The international company is a privately-owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland, with US operations based in Pennsylvania, North Carolina and California.

To learn more about Almac please visit almacgroup.com, e-mail info@almacgroup.com or follow us on Twitter at https://twitter.com/AlmacGroup.

Contact:

Almac:

Denis Geffroy, VP Business Development

Email:denis.geffroy@almacgroup.com

Tel. +44 2838 332200

Contact:

De Facto Communications

Tristan Jervis

E-mail : T.Jervis@Defacto.com

Tel: 00 44 207 861 3019

Mobile: 00 44 771 363 8396

The post Novozymes Biopharma announces collaboration with Almac in Drug Manufacture, Half Life Extension and Targeting Technologies appeared first on Almac.

Almac Launches New [14C]-labelled ADCs Service Offering

admin — Mon, 07 Oct 2013 09:00:37 +0000

Almac has today announced the launch of a new offering for the provision of [14C]-labelled Antibody Drug Conjugates (ADCs).

In recent years the interest in antibody drug conjugates for the targeted treatment of various cancer types has grown massively, and the need for evaluation of the pharmacokinetic profile of these ADCs is becoming more important. Radiolabelling of drugs remains the most effective methodology to facilitate absorption, distribution, metabolism and excretion (ADME) studies, and therefore [14C] labelling of ADCs is becoming a critical part of their development.

The [14C] label is typically placed on either the active drug or the linker moiety, or can be incorporated into both.

Almac’s expertise in this area comes from the integration of biology, chemistry, peptide and purification science, analytical and quality disciplines within their isotope laboratories. The ability to deliver labelled linkers, payloads and complete the bioconjugation within one team shortens timelines and results in a more cost effective solution to clients.

Dr Tom Moody, Head of Biocatalysis and Isotope Chemistry at Almac commented: “As ADCs become more prevalent in drug development, our isotope expertise and technology has kept pace with our customers’ needs. Almac are in the unique position for the provision of all the services required to manufacture [14C] labelled ADCs and this can make a real difference to First in Human study programmes.”

Dr William Watters, Almac’s Isotope Manager added: “The merging of our Biocatalysis and Isotope Chemistry groups, coupled with the presence of an experienced Peptide Synthesis team, ensures that we have the right technical mix to successfully deliver on these complex projects.”

Almac has vast experience in the synthesis of [14C] labelled small molecules, peptides, linkers, and ADCs to both non-GMP and cGMP standards. Almac was also awarded a license by the MHRA in 2009 for the manufacture of [14C] radiolabelled drug product.

The post Almac Launches New [14C]-labelled ADCs Service Offering appeared first on Almac.

Almac Launches SupplyTraQ™ Technology Solution to Streamline Clinical Trial Supply Administration

brendanhagan — Mon, 23 Sep 2013 13:55:24 +0000

Online Tool Enables More Cost-efficient and Accurate Reconciliation and Reporting

Souderton, PA —Almac today announced the launch of SupplyTraQ™, a web-based drug accountability and reconciliation tool that improves clinical trial drug supply management and simplifies post-trial administration. Compatible with IXRS®, the company’s industry-leading IVR/IWR technology, SupplyTraQ enables users to capture drug supply data in real-time and improve the accuracy of the supply management process.

SupplyTraQ accommodates multiple protocols and study designs, offering users a cost-effective method of supporting clinical trials and consolidating trial supply records. Built-in validation checks flag discrepancies as soon as they occur, enabling more accurate data collection and reporting at trial sites and distribution depots.

“SupplyTraQ simplifies the drug accountability, reconciliation, and destruction process – all essential components of clinical trial management,” says Charlie Morris, Vice President, New Products & Services. “By having a real-time view of drug returns, transfers and destruction at both the site and depot levels for discrete drugs, trial managers can take better control of their drug supply and produce higher-quality data.”

SupplyTraQ provides a lower-cost alternative to the manual drug supply management processes used by many clinical trial professionals. Alerts and user-defined search capabilities support fast identification – and resolution – of discrepancies and help to accelerate accountability, reconciliation, and destruction activities. SupplyTraQ further streamlines the process by facilitating authorized, remote review of inventories, enabling site monitors to more efficiently manage their time and site visit schedule. The tool is also adaptable to company-specific processes and trial requirements, which can vary widely depending on study complexity and scope. When used in conjunction with Almac’s IXRS technology, supply management and patient events are completely integrated and yield a holistic view of the drug kit lifecycle.

###

About Almac

‘Partnering to Advance Human Health’

Almac’s Clinical Technologies business unit specializes in interactive technology and service solutions to increase the quality and efficiency of clinical trials. Our solutions include Interactive Voice and Web Response Systems (IXRS®) for patient randomization and drug assignment, patient and clinical supplies management, electronic-patient-reported-outcomes data collection, and Web drug reconciliation. Almac’s technologies have been deployed in over 1900 clinical trials, incorporating over 1.8 million patients in over 80 countries and in more than 60 languages.

To learn more about Almac please visit almacgroup.com, e-mail info@almacgroup.com or follow us on Twitter at https://twitter.com/AlmacGroup.

The post Almac Launches SupplyTraQ™ Technology Solution to Streamline Clinical Trial Supply Administration appeared first on Almac.

Almac Launches Reusable Shipper Option for Temperature-Controlled Distribution

admin — Thu, 19 Sep 2013 08:04:31 +0000

Reusable shippers greatly improve environmental impact and provide cost efficiencies

Almac’s Clinical Services business unit is pleased to announce the addition of refrigerated reusable shippers to its trusted portfolio of solutions for the management and global distribution of temperature controlled clinical supplies. Available as an option to replace single-use shippers for refrigerated shipments, 2°C to 8°C, the innovative, reusable shippers can significantly reduce shipping and storage costs while maintaining payload capacity.

This latest addition is complementary to an already extensive range of cold chain management solutions which include a global team of Cold Chain Experts, a strategic depot network, over 3,000 pallets of dedicated, refrigerated storage facilities, and a proprietary Shipping Temperature Electronic Monitoring System (STEMS) allowing for same day temperature data.

Features of the reusable shippers include identical product space with a smaller overall volume than single-use shippers, thus reducing shipping and storage costs. In addition, the environmental impact caused by single-use shippers is virtually eliminated, and clients will benefit from the removal of tedious destruction processes often required with single-use shippers. The refrigerated shippers have been verified by Almac Quality for temperature accuracy and meet Almac’s rigorous quality standards.

Commenting on the latest enhancement, Leon Supplee, Director of Logistics at Almac’s US headquarters in Souderton, PA stated, “With an increase in biologics and temperature sensitive shipments, Almac strives to offer the best in temperature-controlled distribution. The addition of reusable shippers is one more way that Almac has risen to meet the changing needs of our clients and provide further efficiencies in the supply chain.”

Almac also plans to release reusable options for controlled, ambient shipments, 15°C to 25°C and frozen shipments, -25°C to -15°C in the near future.

For more information on our full suite of cold chain solutions and how reusable shipper options can benefit your next clinical trial please contact clinicalservices@almacgroup.com.

Notes to Editors

About Almac:

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

To learn more about Almac please visit almacgroup.com, e-mail info@almacgroup.com or follow us on Twitter at https://twitter.com/AlmacGroup.

The post Almac Launches Reusable Shipper Option for Temperature-Controlled Distribution appeared first on Almac.

Almac Offering TruSight Tumor Profiling Next-Generation Sequencing Service

admin — Tue, 10 Sep 2013 08:43:21 +0000

Almac today announced they are now offering a Tumor Profiling service running Illumina’s next-generation sequencing (NGS) TruSight Tumor™ panel as part of their biomarker discovery, development and delivery solutions.

Almac, a personalised medicine company with CAP accredited and CLIA certified laboratories, extends their portfolio of services by offering TruSight Tumor™ to complement its current range of RNA, DNA and protein based technologies for biomarker analysis.

Almac is currently running many bespoke diagnostic assays for pharma customers for early phase clinical trial enrichment. The TruSight Tumor™ panel enables additional profiling of these patient samples to provide Almac’s pharma partners with further important information on emerging biomarkers that may also impact drug response.

The TruSight Tumor™ panel was developed by Illumina for their MiSeq® system, allowing targeted DNA sequencing and reporting on the mutation status of 26 genes which are most commonly mutated in solid tumors including lung, colon, ovarian, melanoma and gastric cancers.

One of Almac’s key strengths is many years of experience in working with formalin fixed paraffin embedded (FFPE) tissue. The TruSight Tumor™ panel is specifically designed for use with FFPE samples, and enables the highest levels of sensitivity for mutation detection with limited DNA input requirements.

“Almac is committed to the development of personalised medicine through the delivery of a wide range of innovative solutions. We are pleased to announce the expansion of our NGS service to include TruSight Tumor™” said Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic business unit.

Notes to Editors

About Almac

‘Partnering to Advance Human Health’

Almac’s Diagnostic Services business unit is focused on the discovery and development of biomarkers. It utilises its proprietary technology, extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

The post Almac Offering TruSight Tumor Profiling Next-Generation Sequencing Service appeared first on Almac.

Almac Receives Appreciation Award from Otsuka America Pharmaceutical, Inc.

admin — Wed, 31 Jul 2013 13:22:59 +0000

In June 2013, Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, hosted Otsuka America Pharmaceutical Inc.’s (OAPI) Clinical Trial Supply team at Almac’s North American Headquarters in Souderton, PA. The highlight of the meeting was a presentation of an award to the Almac team by Brent Kelly, OAPI’s Director of Clinical Supply Operations. Almac provided crucial clinical supply services for OAPI’s Abilify Maintena^TM(aripiprazole) clinical trial program, supporting the approval of the once-monthly injectable treatment for schizophrenia earlier in 2013.

“Pictured above is Almac’s Global VP of Operations, Celine Bradley, receiving an award of appreciation from Brent Kelly on behalf of Otsuka America Pharmaceutical, Inc. for Almac’s support in their Abilify Maintena^TM (aripiprazole) Product Study.”

This recognizes Almac’s commitment to quality, customer service, and operational excellence. Commenting on the award Celine Bradley, Almac’s Global VP of Operations said, “I am proud to receive this award from one of our valued customers, and I would like to congratulate OAPI on their successful registration of the Abilify Maintena product. Almac’s core values include our commitment to quality and customer focus, and it is very satisfying to have a client recognize when we have delivered on these. I would like to commend the Almac team for their dedication to successful and timely completion of this project. Awards like this highlight the importance of clinical trial supply in enabling our partners to make a real difference in patients’ lives.”

For further information on the benefits of partnering with Almac, visit our website or contact us today.

About Almac

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS(R) technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

To learn more about Almac please visit almacgroup.com, e-mail info@almacgroup.com or follow us on Twitter.

The post Almac Receives Appreciation Award from Otsuka America Pharmaceutical, Inc. appeared first on Almac.

Almac Introduce Contained Drug Handling and Bottling Capabilities in EU and US Clinical Services Sites

admin — Tue, 02 Jul 2013 09:11:19 +0000

Almac’s Clinical Services business unit has expanded its service offering for dispensing and bottling solid dosage products by introducing enhanced containment equipment and processes at its EU and US headquarters.

Managing Director of Almac Clinical Services, Dr Robert Dunlop commented, “In recent years we have experienced an increase in demand for facilities equipped to handle compounds of a higher potency. As a customer orientated company Almac saw an opportunity to meet the needs of its client base. This development at our European and North American Headquarters is the latest example of how Almac constantly strives to advance its service offering to reflect the needs of the drug development industry. “

Following successful installation and validation, the facilities are now operational and Almac welcome packaging discussions with companies who have potent products in their pipeline. For more information on Almac visit almacgroup.com

ENDS

Notes to Editors:

About Almac

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new North American Headquarters located in Souderton PA.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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ALMAC ANNOUNCES FURTHER EXPANSION AND 229 NEW JOBS

admin — Tue, 11 Jun 2013 13:44:00 +0000

Following the success of one of its key client partnered products, Craigavon-based pharmaceutical company Almac, has announced the commercial manufacturing expansion. Together with the recent completion of a new non-GMP drug development facility at the Craigavon site this dual expansion represents a total investment of £13.7million, which includes some financial support from Invest Northern Ireland. Over the next three years up to 229 jobs will be created across both projects.

The product, a laxative drug, which is contract manufactured by Almac, has recorded robust sales growth year on year throughout the UK and Europe. With existing facilities at full capacity and further demand forecast in a number of new markets Almac decided to focus all production in Northern Ireland with additional equipment and resources in Craigavon. The investment will deliver blending equipment, an automated packing and integrated cartoning line which will enable high volume bulk commercial manufacturing scheduled to begin in November 2013.

Also at the Craigavon site Almac is experiencing growth through the creation of a new 13,400 square feet formulation development facility and analytical laboratories. This facility focuses on the development of tablet and capsule formulations for new drugs which are in the early stages of development and which have not yet reached the market. The new “non-GMP” facility will enable greater speed in formulation and process development, by creating an environment where development work can be progressed quickly and efficiently, free of many of the constraints usually associated with drug manufacturing.

Graeme McBurney, President & Managing Director of the business unit explains, “The laxative product has been a great success in the UK and increasingly in European markets. The marketing and promotion of the product by our contract customer has been very effective and significant growth potential in several new territories such as China has been identified. Centralising and expanding our production in Craigavon will mean more cost effective manufacturing and optimal quality control and distribution.”

“We are also delighted to see the completion of the new non-GMP facility on site which, alongside Almac’s existing GMP capability, will enable us to operate with improved speed and efficiency in the early stages of projects. This latest addition makes Almac a much more attractive proposition to international clients who seek streamlined, one stop drug development solutions.”

Enterprise Minister Arlene Foster said, “This investment is good news for Craigavon and will reinforce Northern Ireland’s position in the wider life sciences sector. The 229 new jobs will deliver almost £5.5 million annually in salaries, bringing an important and positive economic boost which will benefit local people.”

“Almac has a reputation for excellence in the international pharmaceuticals sector and today’s announcement will ensure that it remains in a competitive position and can continue to meet the needs of its global client base.”

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Almac Employees Reward Macmillan Belfast, Mindwise Lurgan and Craigavon’s Neonatal Unit in Annual Charity of Choice Survey

admin — Fri, 07 Jun 2013 13:44:53 +0000

Craigavon-based company Almac has made a £1,000 donation to each of the three charities its employees have selected as part of Almac’s Employee Charity of Choice initiative. The initiative is one of Almac’s various charity programmes aimed at helping individuals and communities in Northern Ireland and further afield. The annual Employee Charity of Choice survey was sent out by Almac’s Charity Committee to all Craigavon-based employees, asking them to select their top three out of six identified charities. Macmillan Cancer Support in Belfast, Mindwise in Lurgan and the Neonatal Unit in Craigavon are this year’s chosen charities.

Almac’s employees boast a very successful track record in terms of fundraising for charities. They regularly participate in charity raffles, organise collections of Christmas presents for disadvantaged children, select their charity of the year and much more. Contributing to supporting local communities is an essential element of the company’s ethos and Almac’s staff are always ready to get involved.

Whether they support cancer patients and their families, individuals suffering from mental illness, or provide medical attention to babies born prematurely or with health concerns, charities rely heavily on the support of local businesses like Almac to sustain their services and alleviate feelings of isolation and powerlessness whilst addressing at the same time practical day-to-day needs in their local community.

Wendy Lyness, Chair of Almac’s Charity Committee, said: “Almac is delighted to support its employees’ choice by awarding £1,000 to Mindwise Lurgan, Macmillan Belfast and the Neonatal Unit in Craigavon. Almac employees have always been very supportive of charities and as a company we have ensured that a relevant committee and programmes were put in place to efficiently promote charitable initiatives and run successful fundraising events. We are delighted that the money has been allocated to such worthy charities and will be used towards caring for vulnerable individuals and communities.”

The post Almac Employees Reward Macmillan Belfast, Mindwise Lurgan and Craigavon’s Neonatal Unit in Annual Charity of Choice Survey appeared first on Almac.

You don’t need to wear a lab coat to work at Almac!

admin — Fri, 26 Apr 2013 09:11:56 +0000

Keen to dispel the myth that “only scientists may apply”, Almac are hosting a recruitment fair at the Europa Hotel in Belfast on Thursday 2 May (8am-8pm) where they will discuss the various Project Management posts and associated benefits currently available at their main Craigavon site.

Although Almac recruits on a rolling basis as its facilities keep expanding, the perception that only candidates with a scientific background will be considered is proving difficult to shift.

To nip this myth in the bud, Almac are hosting their very first recruitment fair to engage on a one-to-one basis with potential candidates and tease out the essential qualities for the available posts. Visitors could well be surprised to discover that they fit Almac’s job profile requirements perfectly, and could end up stepping onto a successful career ladder before spring gives way to summer.

A total of 14 positions are immediately up for grabs in the Clinical Project Services department and will suit candidates with an organised, problem-solving mind combined with good customer skills and a knack for managing project scope and timelines. Over the next few months, eight further Project Management positions will be advertised and the fair offers the perfect opportunity to meet Almac’s recruitment specialists and be noticed.

Abi Pesun, Director of Clinical Project Services of Almac’s Clinical Technologies business unit, says “Scientific and clinical services cannot function to optimal efficiency without the essential support our existing 50 Project Managers provide. We are looking forward to bringing in more enthusiastic Project Managers with varied specialities encompassing IT, logistics, customer service and more.

“Aside from working for an award-winning business offering excellent working conditions, employees also have access to opportunities for learning and development, helping them to secure professional roots and develop within the Almac family. We hope the recruitment fair will dispel misconceptions about Almac and show that indeed it takes all kinds to make Almac the extremely successful company it has become over the years.”

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Almac Receives FDA Inspection Approval

admin — Wed, 20 Feb 2013 10:03:02 +0000

Following from successful MHRA audits in 2011, Almac’s Sciences Business Unit has completed a successful inspection of its analytical facilities at its Craigavon Headquarters, Northern Ireland from the US Food and Drug Administration (FDA). The inspection concluded with no objectionable conditions (483 observations) nor recommendations for improvements.

The inspection of the control testing laboratory was in support of pre-approval inspections for products for which Almac Sciences are named as the contract test laboratory. The 3-day inspection covered the Quality and Laboratory Control systems and included tours of all test laboratories and specialist analytical facilities including mass spectroscopy laboratories. .

Commenting on the approval, President and Managing Director, Stephen Barr said:

“We are delighted with the outcome of this inspection. We have now established a track record with both authorities which highlights our strong focus on compliance and regard for regulatory standards. This outcome is even more significant with the completion of our expanded API facility, and focus on late phase clinical development projects. Our clients can be further assured that our systems and procedures are robust and their products will be delivered to the highest quality.”

Alan Chambers, Head of Quality Assurance added,

“This success confirms Almac’s dedication to delivering the highest quality standards. To complete this inspection with no findings is testament to the knowledge and expertise of the entire Almac workforce. We are committed to building on these strong foundations with continual investment within our quality systems.”

Almac is also pleased to announce expansion of its manufacturing and support facilities at its Craigavon plant. These include an extended API facility, which doubles the current GMP Active Pharmaceutical Ingredients (API) manufacturing capacity, and expansion of its stability storage chambers with also a doubled capacity increase.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

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Almac and DSM Collaboration Agreement in Biocatalysis Continues with Success

admin — Mon, 18 Feb 2013 09:32:30 +0000

In October 2012, Almac announced a collaboration agreement with DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM N.V. (NYSE, Euronext: DSM KON), in the field of biocatalysis to provide sustainable manufacturing services to the pharmaceutical industry, and is pleased to report the continuing success of the relationship, including the successful transfer of enzymes for enzyme screening, process development and scale-up manufacture.

The agreement grants both parties access to their enzyme platform technologies, services and expertise for the manufacturing of active pharmaceutical ingredients (APIs). Almac’s expertise in rapid enzyme identification, scale-up and implementation into early phase projects complements DSM’s experience and track record of over 30 commercial manufacturing bioprocesses run on a multi-ton scale. This gives customers of either party access to enzyme expertise and assets resulting in cost-effective, green processing at all phases of development from preclinical to commercial manufacturing scale. The collaboration also enables Almac to offer its customers a preferred partner for large-scale production.

Since then, Almac and DSM have initiated and completed multiple projects together in the fields of ketoreductase, transaminase, biooixdation and hydrolase. Having access to the largest portfolio of off-the-shelf enzymes has really aided in moving projects from conception to reality for customers of both companies.

Dr. Tom Moody, Head of Almac Biocatalysis, stated “The success of the projects undertaken between Almac and DSM already demonstrates there is a market for scalable green technologies to access difficult-to-make chiral chemicals. Cost remains a prevalent issue within the industry and the introduction of enzymes into processes earlier in the drug discovery pipeline helps to drive cost down as projects move forward. Our collaboration is delivering real rewards to clients from both a technical and financial perspective”.

Almac’s success in the biocatalysis field was further endorsed recently, by the completion of the Knowledge Transfer Partnership (KTP) with Queens University Belfast to develop, improve and embed bioprocesses in order to facilitate the delivery of novel products for its biocatalysis business. The project was awarded the highest grade of “Outstanding” by the KTP Grading Panel for it’s achievement in meeting KTP’s objectives.

Notes to Editors

About Almac

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

About DSM – Bright Science. Brighter Living.™

Koninklijke DSM NV is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of about € 9 billion. The company is listed on NYSE Euronext. More information can be found at www.dsmpharmaceuticalproducts.com and www.dsm.com.

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Almac to deliver insight into Supply Chain Management at Clinical Trial Supply Europe Event

admin — Wed, 13 Feb 2013 09:19:54 +0000

Almac, leading provider of contract services to the global Pharmaceutical and Biotech industries, will play a key role in delivering industry insight on the topic of Supply Chain Management at this year’s 14th Annual CTS Europe event, taking place 26-27^th February in Berlin.

The event offers attendees peer-delivered case studies, extensive networking opportunities and the most current industry insight. It will provide a platform for Almac’s Dr. Mike Hutton to deliver a presentation entitled: “Smart Standardization for IVRS/IWRS: Determining a Standard Approach while still Retaining Flexibility”” Supply Chain Management Expert Martin McGlone will be onsite for one-to-one consultations throughout the duration of the two day conference.

Looking forward to the event, Mr McGlone commented; “Almac has been listening to its client’s needs and we are committed to delivering innovative and cost-effective solutions in line with trial timelines through the use of market-leading technologies (IXRS) and our dedicated Supply Chain Management personnel,“ adding “We are delighted to be attending CTS Europe again this year to share thoughts on delivering efficiencies in the clinical trial supply chain with our industry colleagues.”

Notes to Editors

About Almac

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Almac launches US commercial packaging operations with successful FDA inspection and new client partnership

admin — Wed, 06 Feb 2013 09:14:51 +0000

Almac today announces the successful inspection of its new US Commercial Packaging operations located in Audubon, PA by the Food and Drug Administration (FDA). The inspection took place on the 9^thand 10^th January 2013 from which the regulatory body concluded that the Pennsylvania based site is fully compliant with Good Manufacturing Practices, with no 483 issued.

Commenting on the inspection, Ian Markwell, Vice President of Quality, said: “We are very pleased with the outcome of our inspection, as it marks the establishment of our US commercial packaging operations with FDA approval for bottle, blister, wallet and vial labeling/packaging.”

Jim McGibbon, US Director of Business Development explained “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the US. Now having been successfully inspected by the FDA, we are ready to commence operations for our first client.”

Almac’s first US commercial packaging client, a US-based diversified healthcare company, is an existing long term client partner of its UK operations for both formulation development and contract commercial manufacture services. Initially Almac will supply three commercial products with bulk tablet and capsule manufacture taking place in Almac’s EMA and FDA approved commercial facility in the UK, with final bottle and blister packaging taking place in Audubon.

“This is a significant first contract for the Audubon facility filling in excess of 4M finished packs per annum, so it’s proving a busy start to the year!” added McGibbon.

Almac’s new FDA approved, US commercial packaging facility in Audubon, PA, offers flexible packaging solutions from primary packaging of solid oral dosage forms to customized secondary labelling and packaging of sterile biopharmaceutical products for both established US products and niche/orphan drug launches alike.

Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

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Almac Successfully Completes Knowledge Transfer Partnership with Queens University with Highest Accolade

admin — Mon, 21 Jan 2013 09:47:28 +0000

Almac is pleased to announce the successful completion of the Knowledge Transfer Partnership (KTP) with Queens University, Belfast to develop, improve and embed bioprocesses in order to facilitate the delivery of novel products for its biocatalysis business. The project was awarded the highest grade of “Outstanding” by the KTP Grading Panel for it’s achievement in meeting KTP’s objectives.

The overall partnership aim was to allow technology transfer of fermentation and molecular / microbiology expertise from Queens University to Almac. Almac met the specific partnership objectives by not only sharing a program of work with academics at Queens, but also attending training courses organised through University College London and embedding key learning back into the company.

The resulting success of this collaboration is that Almac can now deliver a fully integrated fermentation, optimisation and bio-product service to its customers. Since completion of the KTP, Almac have successfully scaled fermentation and bio-oxidation reactions to thousands of litres.

Dr Tom Moody, Head of Biocatalysis and Radiolabelling Services, is understandably delighted with the results of this partnership: “To receive the highest grade of Outstanding is a huge achievement for Almac, and testament to the commitment of the team involved. Not only have we further strengthened our long-standing relationship with Queens University, but we have also increased our service offering within the biocatalysis field to our clients, thus allowing us to compete in an area which was previously beyond our reach.”

This achievement follows from an extremely successful year for Almac’s biocatalysis service offering. 2012 saw the launch of its metabolite synthesis services, winning a Belfast Telegraph Award in Excellence in Technology, and announcing an industry-leading biocatalysis collaboration with DSM Pharmaceutical Products.

Notes to Editors

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Almac Doubles Drug Product Development Capacity with a New Non-GMP Facility

admin — Mon, 14 Jan 2013 09:18:51 +0000

Almac is pleased to announce the expansion of our drug product Pharmaceutical Development services with the creation of a new non-GMP formulation development facility and two new analytical laboratories at our UK headquarters in Craigavon. The new facilities double our current pharmaceutical development capacity allowing us to meet the growing demand for our services, both from existing and new clients

The new non-GMP formulation development facility offers clients greater flexibility and speed in formulation and process development, creating an environment where development work can be progressed quickly and then easily transferred to the GMP environment at an appropriate stage. Although the new facility will be dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs.

Whereas, the existing GMP facilities can support drug product manufacturing from phase I up to registration and commercial scale, the new non-GMP facility will primarily focus on lab-scale experiments, with batch sizes ranging from <1kg up to an expected maximum of 15 kg scale for most technologies.

John McQuaid, VP of Technical Operations explains “Our priority was to ensure we had good integration of all technologies in both the non-GMP and GMP facilities. Duplicating equipment trains means that we can conduct non-GMP work efficiently and then transfer rapidly to GMP manufacturing for clinical and registration batches. We are finding that demand for non-GMP process development work has increased as clients seek to better understand their processes in line with the principles of QbD. This type of work also creates large sample sets for analytical testing and multiple stability studies which is why it was also important that we doubled our analytical capacity in parallel.”

The Almac Group provides a broad range of pharmaceutical services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,300 and is headquartered in Craigavon, Northern Ireland. Its North American Headquarters are in Souderton, Pennsylvania and the company also has sites at North Carolina and California.

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Almac and TTP Labtech form alliance in fluorescence lifetime technology

admin — Mon, 07 Jan 2013 09:55:25 +0000

Combining cutting edge science with first rate engineering

FLEXYTE™ assays harness the power and potential of fluorescence lifetime technology

Almac and TTP Labtech announced today the formation of an alliance in the field of fluorescence lifetime (FLT) technology to provide class leading screening performance. This will give customers of either party access to a broad range of biological applications coupled with the next generation of microplate reader technology.

FLT as a reading modality offers a robust, antibody-free, homogeneous assay platform which enables the user to avoid interference from fluorescent compounds within a screening library. Developed utilising experience in peptide engineering and chemical synthesis and design, Almac’s FLEXYTE™ assays harness the power and potential of FLT to provide an efficient and economical platform for screening and profiling. The evolving assay platform offers solutions for many major therapeutic target classes including kinases, proteases, phosphatases, DUB and an increasing number of epigenetic targets.

TTP Labtech’s Ameon™ system represents the next generation of FLT reader technology. By offering real-time decay curve analysis, the Ameon™ system provides a revolutionary combination of speed, precision, and data quality for FLT assays that can be readily integrated into HTS workflows.

‘The development of the Ameon™ reader by TTP Labtech has introduced an exciting new dimension to FLT technology and we are pleased that Almac’s FLEXYTE™ customers will be able to benefit from this advance in reader technology’ said Dr Stephen Barr, President and Managing Director of Almac Sciences.

‘We are excited by the potential of the FLEXYTE™ and Ameon™ reader combination to deliver robust, cost-effective screening results and enhanced productivity through better discrimination of lead compounds’ said Dr Wayne Bowen, Chief Scientific Officer of TTP Labtech.

Video Interview:

Wayne Bowden from TTP Labtech tells SelectScience how this alliance will give customers access to a broad range of biological applications coupled with the next generation of microplate reader technology. Wayne also tells us more about TTP Labtech’s Ameon™ system, which represents the next generation of FLT reader technology. In addition Robert Grundy from Almac discusses how FLEXYTE™ assays harness the power and potential of FLT to provide an efficient and economical platform for screening and profiling. Click here to view

Editors’ notes

About Almac

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

About TTP Labtech Limited

Based near Cambridge, UK, TTP Labtech creates, designs and manufactures robust, reliable and easy-to-use instrumentation to offer life scientists better tools and techniques, simplifying complex operations, saving time and material costs.

We provide state-of-the-art solutions developed for specific product areas including: cell-based screening (acumen^®, mirrorball^®); sample management (comPOUND^®), low liquid handling (mosquito^®) and the management of analytical automation (lab2lab).

TTP Labtech is owned by its employees, and our continued drive to innovate combines cutting edge science with first rate engineering, manufacturing and outstanding customer support.

For further information please visit www.ttplabtech.com

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Charlie Morris Appointed to Almac’s Clinical Technologies Executive Team

admin — Wed, 12 Dec 2012 09:08:58 +0000

The Almac Group’s Clinical Technologies business unit is pleased to announce that Charlie Morris has joined the company as Vice President of New Products and Services. In this role, Mr. Morris will report directly to Jim Murphy, President of Almac Clinical Technologies, and will oversee the development of Almac’s IXRS^® technology and enhance the company’s metrics-based discipline to the software development process.

Mr. Morris brings extensive experience in systems management and development to Almac. His varied background includes service in the financial services, government, and medical technology sectors. He has served in all stages of the systems development process, from inception to development to execution, and has significant experience managing international personnel.

Mr. Morris joins Almac after spending more than ten years serving as the Chief Technology Officer of Princeton Financial Systems (PFS), where he created and implemented multi-year IT strategic plans to grow and improve the PFS information technology infrastructure. He led a team of technical staff in the development, integration, and continuous improvement of a suite of investment accounting, compliance, and data warehousing applications to support financial services industry clients. Prior to his nearly two decades at PFS, Mr. Morris served as Director of Applications Development at Telescan Limited, building and implementing teleradiology systems. He began his career in military contracts where he developed flight simulation, anti-submarine warfare, and naval intelligence systems.

Jim Murphy, President of Almac’s Clinical Technologies business unit, comments on Mr. Morris’ appointment: “We are thrilled that Charlie Morris has joined Almac. He will be instrumental to the continued development of our IXRS^® integrated web and phone-based platform. Given his breadth of system development leadership experience, we are highly confident in his ability to align the New Products and Services department to support accelerated innovation of Almac’s technology. We welcome Charlie to Almac and know he will have a profound impact on the expansion of our technology offerings and client relationships.”

END

About Almac Group

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacturing, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac’s North American Headquarters is located in Souderton, PA.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Almac’s Early Christmas Present to Local Cancer Charity

admin — Fri, 16 Nov 2012 14:17:28 +0000

Craigavon-based company Almac has made a £10,000 donation to the Friends of the Cancer Center Charity to provide support and comfort to cancer patients across Northern Ireland.

The money was raised at the pharmaceutical company’s 2012 charity raffle, when employees were given the chance to buy ballot tickets and win 35 prizes donated by Almac suppliers. Ballot prizes included an Apple Macbook Air Laptop, an Apple iPad and a football signed by the Manchester Utd team. All proceeds were donated to the Friends of the Cancer Center charity.

Friends of the Cancer Center are based at the Cancer Center at the Belfast City Hospital, Northern Ireland’s regional center of excellence for cancer diagnosis and treatment. The ‘Friends’ charity has been tirelessly fundraising for the past three decades to support projects which are outside and in addition to the provisions made by the Health Service, such as medical research, the funding of medical equipment, the provision of comforts to improve the quality of life for patients and their families and even the creation of jobs to help with diagnosis and treatment. ‘Friends’ have to date successfully funded some major projects, responding to needs highlighted by the Cancer Center’s medical staff.

Colleen Shaw, Director of the Friends of the Cancer Center, said: “We are delighted to receive this very generous donation from Almac. The charity relies entirely on voluntary donations and it will make such a difference to the thousands of children, young people and adults with cancer across Northern Ireland that we help each year.”

Receiving the donation on behalf of the charity, Elaine Shaw, Friends of the Cancer Center Breast Oncology Clinical Nurse Specialist, said: “People often experience feelings of powerlessness when they have cancer. They have to spend time in impersonal surroundings, get their heads around diagnoses that can be difficult to explain, and cope with the emotional and psychological consequences of their illness. The Friends of the Cancer Center supports patients every step of the way by funding research, equipment and complementary therapies to help both patients and their families to cope better in traumatic times. Almac’s outstanding donation will greatly help us in our efforts to support even more patients and families across Northern Ireland.”

Alan Armstrong, CEO of the Almac Group, said: “Our staff are always very enthusiastic when it comes to supporting charities. This year was no exception and Almac’s charity raffle was a very successful event.

Since 2006 and thanks to Elaine Gibson, our Global Travel and Events Manager, who has worked tirelessly over the years to organise the raffle and secure the best fundraising opportunities, we have raised well over £60,000 for a wide range of local charities including the Northern Ireland Chest Heart & Stroke Association and the Southern Area Hospice amongst others. Our sincere thanks go to our many suppliers for the kind generosity in supplying prizes for the draw, and of course to our staff who gave generously and participated in the raffle event. We are delighted that the money raised will go towards caring for cancer patients and their families in the most challenging of times.”

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Recycling works: Almac’s new environment initiative saves £72,000 per year

admin — Wed, 07 Nov 2012 14:10:30 +0000

Following the launch of research, pharmaceutical development and manufacturing company Almac’s new recycling initiative in May 2012, the amount of recycled waste at Almac dramatically increased from 19% to 70% in just a couple of months, and has since remained at around 70%. Almac’s environmental set up now consistently saves the company £6,000 per month.

Thanks to a dynamic approach to recycling, Almac’s Antrim-based subcontractor McQuillan Envirocare manages all waste on site and new materials have been added to the recycling list, such as aluminium. Unsightly open skips have been replaced by 100 different wheelie bins and mini ‘recycler’ trains travel up and down the yards, keeping them in optimal condition. Beyond making Almac a ‘greener’ place to work in and to live close to, haulage fees and landfill tax have decreased, encouraging further savings.

McQuillan Envirocare’s Technical Manager, Neil McCauley stated: “We work in partnership with Almac to ensure their environmental and sustainability obligations are met through current and innovative waste management techniques. As our largest client, Almac helped to create new jobs by the employment of dedicated McQuillan Envirocare staff and indirectly by securing several jobs already within our organisation. We value this close working relationship and look forward to continued success over the coming years.”

Almac, one of Northern Ireland’s largest employers, is keen to successfully carry out its environmentally-friendly initiative not only in terms of its production waste, but also in terms of office and household waste, leading by example by involving each of their employees in the process. Recycling bins are available in offices and staff are actively encouraged to use them and to change their environmental behaviour at work and hopefully at home.

Wayne McMeekin, Almac Group HSE Manager said: “Back in April 2012, Almac was recycling 19% of its waste. The original target agreed within our new environment initiative was to reach 40% in December. We are delighted that all our hard work has paid off to the point of reaching 70% waste recycling in June 2012 and maintaining a steady performance since, saving Almac £72,000 per year. This is a fantastic result, which benefits not only the company in terms of savings but also Northern Ireland and its residents in terms of enjoying a better quality of life and a solid reputation in terms of caring for their environment.”

Ends

Notes to Editors

The company employs over 3,300 individuals and is headquartered inCraigavon,Northern Ireland.USoperations are based inPennsylvania,North CarolinaandCalifornia.

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Almac increase early phase ‘hit to lead’ chances with Pre-Clinical Screening Packages

admin — Wed, 10 Oct 2012 08:17:41 +0000

Almac’s solid state services group have created a series of pre-clinical screening packages for clients to identify their candidate’s chances of success much quicker than using traditional mechanisms.

The package, a unique offering within solid state services companies, utilises a smart, fast and economical approach for lead identification. Designed to identify candidates with drug product like characteristics, it will also highlight the potential pitfalls associated with the molecules. Experimental efforts concentrate on establishing the physical/chemical, solubility, stability and polymorphic characteristics of each candidate. The information generated can then be used to make a rational decision for lead identification.

Commenting on the launch of this extended offering, Linda McCausland, Head of Physical Sciences, said:

“We are excited to be in a position to offer this package to our clients. Not only is it affordable, but its output will allow a rapid decision on whether to progress candidates further through early stage development. With speed to market being the most critical factor in sustainable drug development, utilising this service can make a real difference in investment and timelines.”

Established in 2008, Almac’s solid state services group are equipped with state of the art analytical research and development technologies and specialise in solid form characterisation, screening and selection and crystallisation process development.

For further information, Almac will be exhibiting at the forthcoming CPhI (Booth 10E41) and AAPS (Booth 3027) conferences.

Notes to Editors

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Almac Concludes Commercial API Manufacturing Facility Expansion Plans

admin — Tue, 09 Oct 2012 08:11:35 +0000

In response to client requirements, Almac’s expansion of their API manufacturing facility at its European Headquarters in Craigavon, UK is near completion, and will be operational by the end of the year. This upgrade includes installation of two 1,000L reactors and state-of-the-art pressure filter dryer, which allows production of GMP Active Pharmaceutical Ingredients (API) up to 150kg batch size.

Almac’s strategy to increase market share in late phase clinical development is reaping rewards, and clients are already seeing the advantages of having one constant manufacturing partner through each phase of clinical development. “Almac’s investment has further demonstrated our goal of being the outsourcing partner of choice through all stages of clinical development.” stated Denis Geffroy, VP Business Development. “We are delighted to have the scale to share the manufacturing journey with our clients from preclinical phase to full commercialisation.”

Clients can also leverage Almac’s API and Drug Product integrated offering where API manufacture and finished drug production is carried out on the same site, ensuring reduction in costs and timelines whilst maintaining scientific continuity. Almac’s advantage of hosting all facilities on one site have led to the successful technology transfer of small molecule and peptide projects from lab development to large scale manufacture.

For further information, Almac will be exhibiting at the forthcoming CPhI (Booth 10E41) and AAPS (Booth 3027) conferences.

Notes to Editors

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Almac and DSM Sign Collaboration Agreement in Biocatalysis

admin — Mon, 08 Oct 2012 08:27:25 +0000

Almac is delighted to announce a collaboration agreement with DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM N.V. (NYSE, Euronext: DSM KON), in the field of biocatalysis to provide sustainable manufacturing services to the pharmaceutical industry.

The agreement grants both parties access to their enzyme platform technologies, services and expertise for the manufacturing of active pharmaceutical ingredients (APIs). Almac’s expertise in rapid enzyme identification, scale-up and implementation into early phase projects complements DSM’s experience and track record of over 30 commercial manufacturing bioprocesses run on a multi-ton scale. This will give customers of either party access to enzyme expertise and assets resulting in cost-effective, green processing at all phases of development from preclinical to commercial manufacturing scale. This collaboration will also enable Almac to offer its customers a preferred partner for large-scale production.

Alexander Wessels, CEO of DSM Pharmaceutical Products, stated, “Working with the Almac Group marks further advancement of DSM’s stated strategy towards strategic partnerships to excel in providing new customer solutions. DSM is a global leader in applied biocatalysis, providing high quality custom manufacturing and development services to the pharmaceutical and biopharmaceutical industries. Via this agreement, we maintain our commitment to the future of pharma manufacturing, adding to our green chemistry toolbox, which also includes complex chemical solutions and more efficient manufacturing with micro reactors, where DSM is unique in its pilot to commercial scale up offering.”

Dr. Tom Moody, Head of Almac Biocatalysis, stated “This collaboration has come at the right time as more and more customers need scalable green technologies to access difficult-to-make chiral chemicals. Having access to the right enzymes today will drive ‘hit to process’.” The introduction of enzymes into processes earlier in the drug discovery pipeline will therefore help to drive cost down as the projects move forward”. Dr. Stephen Barr, Managing Director of Almac’s Sciences business unit, added, “The synergies between Almac and DSM are not superseded today by any other collaboration in this area. Our customers will see real rewards from the fact that any bioprocess developed can go from conception to manufacture quickly within this agreement.”

Daniel Mink PhD, Corporate Scientist Biocatalysis and (Bio)-Organic Chemistry at DSM comments:

“One important success factor for implementing enzymatic routes is access to a diverse range of biocatalysts. DSM is continuously expanding its unique enzyme collection of more than 3,000 enzymes through in-house development as well as innovative partnering models. The collaboration with Almac completes the latest phase in this process. Together we will be able to offer a complete package serving the pharmaceutical industry at all stages of development from preclinical to commercial scale — bringing biocatalysis to the next level.”

Notes to Editors

About Almac

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

About DSM – Bright Science. Brighter Living.™

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Almac expands UK commercial capacity with the acquisition of new blistering technology

admin — Wed, 03 Oct 2012 08:26:47 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, is pleased to announce that it has expanded its MHRA/FDA approved UK commercial packaging facility with the acquisition of a state-of-the-art Noack N 623 blister packaging line from Romaco.

The acquisition comes in response to growing client demand for enhanced flexibility related to larger blister sizes and innovative multi unit blister formats, coupled to a requirement for non permeability and enhanced environmental protection, particularly product humidity control.

This highly flexible, cGMP compliant technology can be configured to process both thermoform and coldform materials, with maximum blister sizes of 220mm x 155mm. With its automatic feeding system, filling inspection and ejection station and shorter set-up times, the line provides increased productivity, processing over 25,000 blisters per hour, including multi-product blisters.

“Blister size and dosage formats are becoming increasingly more complex. Additionally, product handling for innovative new molecules often requires enhanced environmental controls. This investment allows Almac, through its Pharma Services business unit, to offer this additional flexibility,” says Geoff Sloan VP of Manufacturing Operations. “Through this acquisition, coupled with our imminent entry into the US commercial packaging market, we continue to expand our capabilities and flexibility to meet our client’s needs.”

“The blister technology from Romaco Noack offers high OEE values and low lifecycle costs. Product changeovers are carried out easily and cleaning is quickly done. Our machines prove themselves flexible in operation and versatile in use.”, says Bernd Webel, Sales Director, Romaco.

For more information on Almac’s commercial packaging capabilities, visit https://www.almacgroup.com/commercial-services

Almac will be exhibiting at CPHI Madrid, 9^th – 11^th October 2012 (booth number 10E41) and AAPS Chicago, 14^th – 18^th October 2012 (booth number 3027).

Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 individuals and is headquartered inCraigavon,Northern Ireland.US operations are based inPennsylvania,North Carolina andCalifornia.

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Successful MHRA Inspection of Almac’s Clinical Services UK Facility

admin — Wed, 26 Sep 2012 08:15:23 +0000

Almac is pleased to announce the successful inspection of its Clinical Services operations located in Craigavon by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The inspection, which occurred from 17^th to 20^th September 2012, was a routine inspection conducted by a MHRA inspector from the regulatory body who concluded that the site continues to be compliant with EU Good Manufacturing Practices, with no critical or major failures observed.

Commenting on the inspection, Paul O’Connor, Vice President of Quality, said:

“Once again we are extremely pleased with the outcome of our inspection. Quality is at the forefront of all our operations and all our employees continuously strive to ensure we have all the necessary processes in place to support our reputation in delivering global regulatory compliance and quality management excellence. This latest inspection is even more significant as it comes at an exciting time as we prepare to implement our new multi-million pound ERP system. This was reviewed intensively – one and a half days in total during the inspection period and resulted in no findings – testimony to our confidence that this exciting new development will further enhance our position as the premium supplier of global clinical supply chain solutions to the Pharmaceutical and Biotech industries.”

Almac has three MHRA approved clinical services facilities globally including our additional FDA assessed US facilities in Souderton, PA & Durham, NC.

Notes to Editors

About Almac

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Almac Launches New Histone Reagents Catalogue and Custom Synthesis Service

admin — Mon, 17 Sep 2012 08:27:59 +0000

Almac has today announced the launch of a new reagent offering based on the provision of homogeneous full length histones with defined patterns of modification. The histone reagents will prove a highly valuable tool for researchers seeking to prosecute key drug targets in the field of epigenetics.

Almac’s unique array of platform technologies for the chemical synthesis of proteins, enable the provision of pure full-length natural histones containing a wide variety of post-translational modifications at any specified site(s) within the protein. The reagents are set to be offered through a catalogue of modified histones and additionally as a custom synthesis service to meet bespoke customer demands. Almac believes this will provide the epigenetic research community with a unique source of enabling research tools. The modified histone reagent provision complements Almac’s growing range of FLEXYTE® FLT assays for epigenetic targets.

‘This is a first class example of how Almac can harness its unique protein synthesis capability to provide a much needed source of tools to the epigenetic research field. I am delighted that we are able to offer such capabilities.’ commented Dr Charles Shields, Vice President of Peptide and Protein Technologies at Almac.

Notes to Editors

About Almac

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Almac announces launch of Next Generation Sequencing service for personalised medicine

admin — Tue, 21 Aug 2012 08:19:58 +0000

Almac today announced that it is launching a Next Generation Sequencing service to further expand its range of solutions supporting the development of personalised medicine. The purpose of this service is to support Almac’s BioPharma partners in the development of molecular tests for trial enrichment and companion diagnostic development, specifically focussing on targeted re-sequencing

Almac currently offer solutions using microarray, qPCR and IHC and the addition of the Next Generation Sequencing (NGS) platform fully complements this range of clinically focused diagnostic delivery platforms.

Almac previously launched a service focussing on the analysis of Next Generation Sequencing (NGS) data and based on feedback from the market has decided to develop this service further to include data generation and to allow the delivery of NGS based assays in their CLIA lab.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostics business unit and Professor of Molecular Oncology at Queens University Belfast said:

“There are only a limited number of platforms that are truly amenable to diagnostic delivery. The NGS field has now moved to a point where it is a viable delivery platform and as such is a logical addition to our suite of services. We have already begun the process of developing CLIA based assays for important mutations involved in drug response.”

Almac already perform Next Generation Sequencing for Omixon, a bioinformatics company focused on the development of validated data analysis solutions to scientists working in genomics with special emphasis on clinical and diagnostic applications. Attila Bérces, founder and Chief Executive Officer of Omixon said:

“Omixon aims to provide the most accurate and highest quality DNA analysis software. Almac complements our effort by providing the highest quality sequencing data. The MiSeq data we received from Almac is of highest quality which helped Omixon in developing and validating our HLA-typing software. Next Generation Sequencing can revolutionize HLA-typing which is carried out on millions of samples annually.”

Ends….

Notes to Editors

About Almac

Almac’s Diagnostics business unit is focused on the discovery and development of biomarkers. It utilises its proprietary technology, extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Almac Streamline Temperature Sensitive Clinical Supplies with Enhanced Service Offering

admin — Wed, 08 Aug 2012 08:05:50 +0000

Almac, leading experts in the management of temperature controlled clinical supplies, has further enhanced its service offering with the completed expansion of refrigerated (2-8°C) storage and newly developed refrigerated labelling facilities at its UK site. This enhancement doubles Almac’s refrigerated storage capacity at its UK site and comes as a response to a growing number of client requests involving Biologics, Biosimilar Compounds and other temperature critical material.

The labelling, packaging, and distribution of cold chain materials can often prove complicated given the temperature sensitive nature of the products. In most cases, the product has a limited amount of time that it can be out of the specified temperature, whether it be 2-8°C or colder. With the introduction of the refrigerated labelling facility and expansion of refrigerated storage, Almac is able to offer a more streamlined cold chain service by ensuring the material flow is consistently monitored at every stage in the clinical supply chain. The offering, mirrored at the company’s US headquarters in Souderton, PA, is a substantial benefit to existing and potential clients where maintaining temperature control is critical to the shelf life and stability of their compound or the chosen comparator.

Almac has already taken great strides in enhancing the distribution portion of cold chain management by introducing an enhanced cold chain shipper solution. The containers are smaller, lighter and more robust than existing shipper solutions on the market, retaining maximised product space, thus making them a very cost-effective shipping option for Almac’s customers. Sharon Courtney, Head of Distribution, commented ‘In the first 6 months since their implementation, the shippers achieved an impressive <0.33% excursion rate across the board, making this one of the most effective shipping solutions in the industry.‘ Coupled with Almac’s Shipping Temperature Electronic Monitoring System (STEMS), which allows for same day temperature data, Almac delivers a comprehensive and reliable solution for cold chain distribution.

Further assistance in managing the supply chain for cold materials can be achieved through the utilisation of Almac’s in-house Supply Chain Management (SCM) team. The SCM team will have visibility of and be responsible for managing the entire supply chain and will optimise the size and frequency of shipments of cold material, working with clients to develop transit routes that mitigate the risk of temperature excursion during shipment. Ultimately this allows Almac to create and deliver a more efficient process for temperature sensitive materials.

Commenting on these recent developments, Martin Lamb, Vice President of Business Development, said “Our suite of leading cold chain solutions is a response to the growing customer demand for clinical services for temperature sensitive materials. Our goal is to provide closed loop cold-chain solutions tailored towards our customer’s individual needs, remaining mindful that we are servicing an industry wherein effectiveness and efficiency are increasingly sought after attributes.”

Contact a member of our Cold Chain Team today or visit our website for an overview on Almac’s cold chain services.

Notes to Editors

About Almac Group

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, and IXRS® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California

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US Consul General applauds Almac’s economic contribution to the US pharmaceuticals market

admin — Wed, 18 Jul 2012 08:18:25 +0000

Gregory S Burton, the new US Consul General in Northern Ireland, visited Almac’s headquarters in Craigavon today for a first hand overview of the Company’s latest investments in the US, specifically the $10m (£6.4m) state- of-the-art commercial packaging facility in Audubon, Pennsylvania.

Almac, a provider of pharmaceutical development services to more than 600 companies in the pharmaceutical and biotech sectors across the world, is opening the 100,000 sq ft new facility in Audubon to service its customers across the US.

The new facility has already been awarded contracts for two products that will exceed 1.5m bottles per annum. Tablets and capsules will be manufactured in Almac’s Craigavon facility and shipped to Audubon for commercial packing into bottles for distribution to the US market. State of the art packaging lines will enable Almac to process blisters, bottles, wallets and sterile packaged product for the US market.

Gregory S Burton, who has recently taken up the post at the US Consulate in Belfast, took a tour of the Craigavon site and was briefed on the most recent investments in the US, a market that represents around half of the Company’s total biotech and pharmaceuticals business.

“Almac’s investment in the U.S. underscores Northern Ireland’s capacity to contribute to the global economy in high–value sectors like pharmaceutical development. The company plays an important role in my home State of Pennsylvania and I was grateful for the opportunity of viewing their cutting-edge facility in Craigavon.” commented Gregory S Burton

Further to the Audubon investment Almac is also in the process of doubling the size of its Analytical labs in its new North American Headquarters in Souderton, Pennsylvania, which was opened last year by Senator George Mitchell.

Graeme McBurney, Managing Director of Almac Pharma Services, said: “It gives me immense pride to know Almac is a source of direct foreign investment into the US at a time of restricted economic capital. We are investing in the business significantly across the globe so that we can continue to make an improving economic contribution both within our industry and major markets.”

Notes to Editors

The company employs over 3,300 and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

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Almac launches mobile website in response to large mobile user base

admin — Mon, 02 Jul 2012 08:28:53 +0000

Embedded mobile icon means website can be accessed on the move in just one click

Almac is pleased to announce the launch of a mobile optimized version of its website, enabling biotech and pharma clients and prospective customers to access Almac’s content whilst out of the office with only a mobile to hand. The new mobile ready site (designed to work with all mobile operating systems including Android and Apple) contains shortened summaries of all the sections of Almac’s full website broken-down into 6 tabs – ‘Services’, ‘News’, ‘Events’, ‘Locations’, ‘Contact Us’, and ‘Vacancies’.

The new website was created in response to client demands; due to an ever growing number of visitors accessing the main site via mobile devices. The mobile ready site enables users to store an Almac icon on their phone’s screen providing rapid access in just one click, enhanced resolution for all screens sizes, and a search facility enabling visitors to access any content from the full site.

“At Almac we are always looking to help clients with any requirements they have and by launching this new mobile website we are providing even greater accessibility for the significant number of people that view our services and locations through mobile devices. We are one of the first CDMO companies to invest in online technologies to respond to this growing need, providing up to date information on our global portfolio helping to facilitate real time decision making wherever you are” said Philip Diamond, VP Corporate Market Development at Almac.

The new site can be visited on the following address: http://m.almacgroup.com/

Notes to Editors

About Almac:

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Almac Introduces Qualified Person Facilitation Program

admin — Wed, 13 Jun 2012 08:06:22 +0000

Program vastly simplifies and expedites the QP release process

Almac is pleased to announce the Qualified Person (QP) Facilitation Program; a value-add enhancement to Almac’s current suite of QP services. Offered to global clients importing investigational medicinal products (IMP) into the European Union for clinical trial, this solution has been developed to alleviate the complex logistical challenges surrounding the QP Release process as well as provide a deeper level of consulting during this critical stage of clinical trial distribution.

This latest addition to the Almac portfolio is complementary to the already extensive range of services including packaging, labelling and global distribution of clinical supplies. Directly, the on-site QP Facilitation Program enhances Almac’s QP services portfolio which currently includes regulatory guidance, global auditing and import testing. To simplify and expedite the often complicated QP Release process, an Almac Quality Compliance Manager will be placed at the client site in order to explain the release processes and to clearly define the responsibilities for both the sponsor and Almac.

Features of the program include access to a dedicated Quality Compliance Manager on-site that provides supply chain assessment, assembly and completion of relevant documentation necessary for QP Release, and an overall better understanding of all information pertaining to the QP release process. In addition to reducing the burden of handling this process internally, clients will receive unique, study specific guidance from an experienced Quality Compliance Manager who is an expert in the QP Release process.

“The QP Facilitation Programme, through face-to-face interaction, will work to eliminate issues with the QP Release process and effectively remove the preparation for QP Release from the critical path,” said Paul O’Connor, Global Vice President Quality at Almac. “We believe this service to be a tremendous benefit to clients with limited internal resources or those unfamiliar with the QP Release process.”

By participating in the QP Facilitation Program, Almac clients will find the QP Release process more straightforward and accomplish necessary documentation in a more timely fashion.

Notes to Editors

About Almac:

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Almac and VTU Technology form collaboration to provide customers with high yielding, fast-track generation of site-specific modified products

admin — Mon, 11 Jun 2012 08:16:44 +0000

Approach enables homogenous labelled product with retained biological activity

Almac and VTU Technology announced today their collaboration to offer joint services for the expression of recombinant proteins with site-specific modification and labelling, such as PEGylation for half-life extension of proteins.

Almac has previously developed technology for site-specific C-terminal modification of recombinant proteins. The technology can be applied to the generation of PEGylated proteins for half life extension, labelled proteins for PET and SPECT imaging, engineered and bispecific proteins and protein drug conjugates. Currently available protein labelling technologies produce products which are labelled at multiple sites in an uncontrolled manner. This inevitably results in a heterogeneous population of labelled molecules resulting in a net decrease in potency compared to the unlabelled analogue. The Almac approach allows the specific labelling site to be selected and controlled and generates a homogeneous labelled product in good yield with retained biological activity.

VTU Technology, a leading supplier of exclusive technologies and comprehensive services for the development of high yielding, high-performance Pichia pastoris protein expression strains and processes and Almac have recently completed a case study to prove the applicability of Almac’s site-specific PEGylation technology to proteins (single domain antibodies) produced through secreted expression from Pichia pastoris. The study clearly demonstrates the advantageous combination of a powerful eukaryotic expression system with a versatile approach for site-specific C-terminal protein modification and is applicable to a wide variety of modifications including attachment of polymers such as PEG, small molecule labels and synthetic peptides.

“We are delighted that our Pichia pastoris platform enables the production of intein-fusion proteins at high yields and proved to be perfectly compatible with Almac’s site-specific protein modification technology”, said Dr. Thomas Purkarthofer, Head of Business Development at VTU Technology.

“This collaboration between VTU Technology and Almac will help to further demonstrate the broad applicability of our Pichia protein production platform”, Purkarthofer added.

The Almac-VTU Technology alliance provides several benefits to biopharmaceutical companies seeking fast-track protein expression and process development and subsequent site-specific protein modification. This integrated service platform combines two proven and unique technologies. VTU Technology’s high-expression Pichia technology and speed in expression strain and process development along with Almac’s expertise in peptide and protein engineering techniques for the improvement of drug products. This ‘One-Stop-Shop’ offers customers an integrated approach with a smooth technology transfer throughout all phases.

“This exciting collaboration with VTU Technology has enabled us to demonstrate the utility of our unique protein engineering technology in Pichia therefore making our site-specific protein labelling solutions more accessible to the biotechnology community” commented Dr Stephen Barr, President and MD of Almac’s Sciences Business Unit.

VTU Technology and Almac will be exhibiting at the BIO 2012 International Convention in Boston and will be available to provide more information on intein-fusion protein expression and site-specific protein modification at booth 3265 and booth 1422 respectively.

Notes to Editors

About Almac:

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 individuals and is headquartered inCraigavon,Northern Ireland.US operations are based inPennsylvania,North Carolina andCalifornia.

About VTU Technology:

VTU Technology is a leading contract research and development company, providing services for the fast track generation of high performance, industrial protein production strains and economically viable protein production processes for pharmaceutical companies and other protein manufacturers.

VTU’s exclusive Pichia pastoris expression platform is based on its 1^st and 2^ndgeneration AOX1 promoter libraries enabling proper fine-tuning of protein expression. Applied by VTU’s sophisticated team, this cutting-edge platform facilitates the delivery of unparalleled expression levels often achieving more than 10 g/L secreted protein (20 g/L peak expression level) within a few weeks development time for a wide range of proteins including serum proteins, cytokines, fusion proteins, Fabs, antibody derived fragments, scaffold proteins and enzymes.

VTU Technology is part of VTU Group, a provider of comprehensive technology services with over 200 employees and several sites and offices acrossEurope.

For more information about VTU Technology, please visit www.vtu-technology.com or e-mail office.technology@vtu.com.

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Almac Adds High-Speed Clinical Trial Blistering Equipment at US HQ

admin — Mon, 14 May 2012 13:38:20 +0000

Almac announced today the acquisition of the new PharmaWorks TF3 high-speed / large-format blister equipment. The addition addresses a growing industry need for outsourced clinical trial services and follows another recent acquisition, the Bosch GKF 702 over-encapsulation machine. Both pieces of equipment will be housed in Almac’s North American headquarters in Souderton, PA, reinforcing the company’s global capacity by complementing existing equipment currently in the Craigavon, Northern Ireland global headquarters.

The cGMP-compliant equipment provides added value in Almac’s clinical manufacturing capabilities, strengthening the company’s focus on providing clients with a variety of high quality packaging solutions. In a broader scope, it lends itself to strengthen Almac’s service portfolio that addresses the clinical packaging, labelling, and distribution needs of global clients.

Features of the TF3 include a 220mm x 290mm form area, colour vision system, automated seal registration, and a programmable punch station. The machine is equipped with an automated feeder that can accommodate the input of up to 4 different products (tablets or capsules) simultaneously. Capable of speeds averaging 50 indexes per minute, this machine provides convenient and efficient tool-less changeovers.

Almac evaluated a number of high-quality vendors when looking into the purchase of the new blistering equipment. The TF3 was chosen based on its flexible and versatile nature and its ability to most suitably fulfil Almac’s need to expand to meet the growing needs of global clients.

“The purchase of the PharmaWorks TF3 machine will allow Almac to fulfil our customer’s needs by increasing our blistering capacity,” said Dan Megill, Director of Operations at Almac. “This machine offers leading functionality and supplies Almac with a highly flexible format to support our various clients and their packaging needs.

PharmaWorks are at the forefront of forming technology and the support we have received from them has been tremendous. We are pleased with this acquisition and expect it to contribute greatly to Almac’s overall productivity while enhancing our core services.”

Ben Brower, PharmaWorks VP, also commented “As our tag line on the TF3 brochure states – “No compromise: efficiency and flexibility across the entire spectrum of blisters”. I cannot think of a better summary of the TF3. We have included features and technology to solve many of the pharmaceutical industry’s blister production challenges. From our user friendly interface to our laser seal and punch registration features we feel the machine is state-of-the-art. We are proud to count Almac as a continued customer and partner in providing the highest quality in pharmaceutical blister production. Almac will be able to offer its customers unparalleled and equal efficiency whether producing HUD type blisters or large BINGO type blisters.

For more information on Almac’s clinical trial supply service portfolio, contact clinicalservices@almacgroup.com.

Notes to Editors

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Almac installs Uhlmann Blister Line in new US Commercial Packaging Facility

admin — Tue, 01 May 2012 08:07:17 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, is pleased to announce the acquisition of a state-of-the-art, high-speed blister line for their new 100,000ft² US commercial packaging facility in Audubon, PA.

The versatile UPS 4 blister line will process solid oral dose products, providing primary packaging into a range of materials including PVC, PVC/PVDC, Aclar and Alu/Alu. Complete with an integrated C2206 cartoner, the line will provide a highly efficient packaging solution with an output of up to 12,000 blisters per hour, in a wide range of blister sizes.

The line is capable of both multi-product blister processing and online blister printing (both flexographic and digital) addressing the need for enhanced patient compliance, whilst ensuring flexibility of supply.

Enhancing product compliance, the line will include a Total Quality Control Center (TQCC) incorporating a checkweigher and integrated print and vision system for auto – rejection of incorrect print / serialisation data including 2D codes.

The blister line will complement the full suite of highly flexible and state of the art commercial packaging equipment already installed in the new Audubon facility. Supporting high volume marketed products to niche/orphan drug launches, additional key technologies include bottling, walleting and vial labelling/packaging.

Geoff Sloan, VP Manufacturing Operations explained that the partnership with Uhlmann, one of the leading US Pharmaceutical equipment suppliers, was a natural choice. “Uhlmann were able to provide us with a versatile, high-spec blistering line to match ourUSclient requirements for a high quality, flexible commercial packaging solution.”

Ralf Klotz, Regional Sales Manager, Uhlmann commented “The construction and installation of this equipment proved to be a great project. We are looking forward to a long term partnership with Almac as their US Operations continues to grow. The flexibility of this equipment certainly puts Almac in a position as a leader in contract blister packaging”.

For more information on Almac’s service capabilities, visit almacgroup.com/uspack. Almac will be exhibiting at Interphex (booth 1109).

Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland.US operations are based in Pennsylvania, North Carolina and California.

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Almac Rewarded for Excellence in Technology

admin — Thu, 26 Apr 2012 08:27:58 +0000

Almac has been recognised for its cutting edge technological developments, scooping a top award at the recent Belfast Telegraph Northern Ireland Business Awards 2012, in association with British Midland International (bmi).

The Craigavon-based pharmaceutical development company collected the Excellence in Technology award at a ceremony held at the Ramada Plaza Hotel, Shaw’s Bridge, Belfast to reward the best of Northern Ireland’s business community across 12 categories.

Almac has developed new technology which sets it apart in a difficult chemical market which is under threat from Asia. Almac’s Sciences Business Unit has set up a dedicated group for discovering and implementing effective processes for biocatalysis – enzymes which effect desired chemical transformations.

The biocatalysis group has doubled since it was established in 2009 to become an integral part of the company. Almac’s growth in this area has been further enhanced by a £2.5m research and development investment, supported by INI, and the subsequent launch of a biocatalyst technology platform, SelectAZyme™ brand.

Almac is currently collaborating with institutions including Queen’s University Belfast and University College London in a bid to ultimately discover new catalysts with unique properties while providing industrial training opportunities for students and graduates.

The Almac team collected the award from Scott Kennedy, a director and head of the Intellectual Property and Technology team at category sponsor Cleaver Fulton Rankin Solicitors.

Stephen Barr, Managing Director of the Almac’s Sciences Business Unit, said: “Winning this award is recognition that we are at the forefront of technological advances in our field.

“Our unique technology is used in a range of applications from medicinal chemistry to the manufacture of specialist chemicals. It has enabled Almac to enter into complementary industries including flavour and fragrances and biofuel arenas.

“It has a positive environmental impact as it promotes the use of green, renewable clean catalysis and helps lower costs, reduce waste and increase productivity.”

Alastair Hamilton, chief executive of Invest NI, and a member of the Belfast Telegraph Business Awards judging panel said: “Companies which adopt and embrace technology as an integral part of their business model tend to be those which drive growth and success. Each of the shortlisted companies in this category has demonstrated excellence in technology in their own way. However, for its use of new technology to fuel its growth and become a world leader in the pharmaceutical and biotechnology sectors, the panel concluded that Almac is this year’s worthy winner.”

Brenda Morgan, Sales Manager Ireland at title sponsor bmi, added: “Within the annual business calendar there is no other event to equal the impact of the Belfast Telegraph Business Awards. The event provides the business community with the opportunity to share and celebrate the importance and impact of business excellence.

“This year’s awards ceremony highlighted that Northern Ireland is in business, not just business as usual, but business that is competitive and competing on a world stage. The 2012 winners reflect the range and diversity of outstanding business success both at home and abroad. There is a very clear message – the Northern Ireland business community are alive and well and are succeeding in one of the most difficult economic climates for many years.”

Notes to Editors

About Almac

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Almac reports progress in Clinical Technologies Lean Six Sigma Efforts

admin — Wed, 04 Apr 2012 08:15:58 +0000

The Almac Group announced today that its Clinical Technologies Business Unit has made significant progress in advancing its Six Sigma-led quality and productivity initiatives. The program began with the goals of increasing quality and productivity by addressing key issues relating to people, processes and technology. Directed by a certified Six Sigma Black Belt, Almac’s program has trained sixteen Green Belts and three Black Belts, and has now advanced to full-scale deployment across the unit.

Almac launched its Six Sigma program in 2011 with the training of its entire Clinical Technologies’ leadership team and selected staff from each functional discipline in Lean Six Sigma methodologies. This training helped prepare the organization to effectively leverage the team of twenty Six Sigma experts who are currently leading strategically-selected business improvement projects. By adhering to a disciplined, fact-based process excellence methodology, Almac expects its Six Sigma program to deliver increased value to clients, employees and sites, all of whom will benefit from the technology and process improvements currently underway.

Jim Murphy, President of Almac’s Clinical Technologies’ Business Unit comments: “Since our founding, Clinical Technologies has nurtured a learning culture that is focused on customer satisfaction, innovation and continuous improvement. A significant part of our corporate culture involves using metrics and data to make business decisions; this dovetails perfectly with the Six Sigma methodology, a systematic information-driven methodology for improving business performance by reducing, if not eliminating, product and process deficiencies and variation. With Six Sigma in our continuous improvement toolkit, Almac will drive efficiencies that we can pass on to our clients, all of whom are striving to increase the productivity of their R&D efforts.”

Almac selected the Juran Institute, an internationally recognized leader in the field of quality management, as its Lean Six Sigma training and deployment partner. Juran’s Lean Six Sigma program was especially attractive to Almac because it can be implemented flexibly and quickly to achieve performance breakthroughs and sustainable business results. Todd Kole, Almac’s Vice President of Clinical Project Services department comments on Almac’s selection of Juran: “Almac selected Juran as a partner in its Six Sigma training because of its reputation as one of the world’s leaders in both Six Sigma and Lean methodologies. More importantly, Juran took the time to understand Almac’s business, clients and industry and put together a tailored program that would help Almac achieve its strategic and operational goals.”

Notes to Editors

About Almac

Almac’s Clinical Technologies Business Unit specializes in interactive technology and service solutions to increase the quality and efficiency of clinical trials. Solutions include Interactive Voice and Web Response Systems (IXRS^®) for patient randomization and drug assignment, patient and clinical supplies management, electronic-patient-reported-outcomes data collection, patient compliance and Web drug reconciliation. Almac’s technologies have been deployed in over 1800 clinical trials, incorporating over 1.7 million patients in over 80 countries and more than 50 languages.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

About Juran Institute

In 1979, Dr. Joseph M. Juran founded Juran Institute, Inc., an organization aimed at providing research and pragmatic solutions to enable organizations from any industry to learn the tools and techniques for managing quality and performance excellence. Building upon Dr. Juran’s foundation, they now provide a number of services to help clients in all industries. Juran is known worldwide for research, consulting, and training that enables organizations to increase product and service quality, streamline business processes, reduce costs, and heighten their competitive edge.

Juran’s mission is to create value for society and customers through superior quality and sustainable results. Their vision is to be recognized by customers as the best source for achieving that value.

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Almac and Affymetrix Announce a Global Distribution Agreement for Almac’s Xcel™ Array

admin — Thu, 29 Mar 2012 13:02:37 +0000

Xcel™ array optimised for RNA expression profiling from Formalin Fixed Paraffin Embedded (FFPE) samples

Almac today announced that it has signed an exclusive global distribution deal with Affymetrix, Inc. enabling them to directly sell Almac’s proprietary Xcel™ array for biomarker discovery, development and delivery worldwide.

Almac’s Xcel™ array is a high density transcriptome-based microarray that has been optimised for the discovery and development of biomarkers from formalin fixed paraffin embedded (FFPE) tissue. Designed by Almac and built on the industry standard Affymetrix’ GeneChip^® platform, the content of Xcel™ array has been derived from high quality sequence data, as well as mining public gene expression and sequence databases.

The array contains more content than all currently available 3` microarrays, with over 97,000 transcripts including antisense, non-coding transcripts and significant unique content. Working with FFPE enables the potential to profile retrospective samples in tissue banks, a highly valuable resource.

Standard practice is to collect patient samples and store in FFPE and the ability to unlock information from these samples will rapidly increase the discovery opportunities in personalised medicine. Further to this, translating these discoveries into the clinic on an FFPE platform will drive the commercialisation of these biomarkers.

The substantial content on Almac’s Xcel™ array ensures that the platform technology is ideally suited for research in cross-disease areas, a notable advantage to pharmaceutical companies. It has also been designed to include all of the content from the Affymetrix’ GeneChip^® Human Genome U133 Plus 2.0 Array, enabling simple transfer and continuation of existing research.

Kevin Cannon, PhD, Expression Business Lead at Affymetrix commented:

“Almac’s Xcel™ array with its superior design and content derived from multiple cancer types provides an ideal microarray for gene expression profiling from FFPE tissues, unlocking previously inaccessible genetic content for translational research. Researchers now have the ability to carry out retrospective studies for discovery and validation of gene expression biomarkers and translate them into clinical practices. This array represents a significant technology advancement, and combined with Genisphere’s Sensation™ reagents address a much needed FFPE workflow solution for gene expression profiling and biomarker discovery.”

Vice President of Business Development of Almac’s Diagnostics Business Unit, Michael Sloan commented:

“We are very pleased to have entered into this agreement with Affymetrix. The Xcel™ array has proven to be extremely useful in our hands for biomarker discovery both for our in-house R&D and for our clients. This distribution deal with Affymetrix will enable more researchers to see the benefit of the platform.”

Affymetrix will officially launch the Almac Xcel™ array at this year’s AACR annual meeting in Chicago.

Ends….

Notes to Editors

About Almac

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

About Affymetrix

Affymetrix technology is used by the world’s top pharmaceutical, diagnostic, and biotechnology companies, as well as leading academic, government, and non-profit research institutes. More than 25,000 peer-reviewed papers have been published using the technology. Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Santa Clara, Cleveland, Ohio, and Singapore. The company has about 900 employees worldwide and maintains sales and distribution operations across Europe, Asia, and Latin America. For more information about Affymetrix, please visit http://www.affymetrix.com.

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Almac’s Clinical Trial Workshop Series to return in 2012

admin — Thu, 15 Mar 2012 09:21:22 +0000

Almac will be hosting a series of complementary ‘lunch and learn’ style workshops across Europe and the US this spring tailored towards clinical trial / outsourcing professionals from Pharmaceutical and Biotech companies. The content of the workshops, which are titled ‘“Blinding Techniques and Analytical Support for Clinical Trials”, will provide an informative and educational insight into the challenges involved in Phase I-III trial encapsulation, blinding, packaging, and labelling as well as the associated analytical considerations in this area.

Robert Dunlop, Managing Director at Almac commented: “The workshops are designed to promote learning and encourage dialogue amongst members of the clinical trial profession. Attendees can share experiences, discuss common challenges, and ultimately take away with them methods for overall success in clinical trials.“

As with previous workshops delivered by Almac, the content demonstrates how the integrated service offerings from the Almac Group deliver a more streamlined supply chain network in an industry wherein time and resources are limited.

The venues and dates for this year’s workshops can be found below.

US dates / locations

Location: Durham, NC

Date/ time: Tuesday, 24- April 11am-2pm

Venue: The Mez, 5410 Page Road, Durham, NC

Location: Bridgewater, NJ

Date/ time: Thursday, 26 – April 11am-2pm

Venue: Maggiano’s, 600 Commons Way, Bridgewater, NJ

Location: Boston, MA

Date/time: Tuesday, 1 – May 11am-2pm

Venue: Legal Sea Foods, 5 Cambridge Center, Cambridge, Massachusetts

Location: San Francisco, CA

Date/ time: Thursday, 3 – May 11am-2pm

Venue: Medallion Steakhous e, 1095 Rollins Road Burlingame,CA94010

EU dates / locations

Location: Cambridge UK

Date/ time: 3rd May -9:30 am- 2pm

Venue: 24 Cambridge Science Park, Milton Road , Cambridge CB4 0FN

Location: Copenhagen

Date/ time: 8th May -9:30am – 2pm

Venue: Scandic Hotel Raadhuspladsen 57 1550 Copenhagen

Location: Basel

Date/ time: 10th May -9:30 am – 2pm

Venue: Swissôtel Le Plaza Basel Messeplatz 25 4005 Basel Switzerland

To register for an event near you, visit the registration sites here. Seats are limited, and registration is required to secure your place. For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

Notes to Editors

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Almac and SRC to boost training for science careers

admin — Thu, 15 Mar 2012 09:18:19 +0000

Training for science careers in Northern Ireland is set to receive a boost thanks to a partnership between Almac and Southern Regional College announced today.

The Craigavon-based pharmaceutical development company has said it will create eight scientific apprenticeships for SRC students, starting in September this year.

The announcement was made at the opening of a new state-of-the-art science laboratory at the Portadown campus of the College and will see Almac providing two year apprenticeships to16 to 24 year olds studying NVQ laboratory technician courses to Level 3.

Stephen Barr, Managing Director of Almac Sciences, who officially opened the new science laboratory, said: “Almac is committed to the development of effective partnerships withNorthern Ireland’s schools, colleges and universities and working with SRC on this initiative to train local young people for science careers is a great example of this.

“For eight young people September will mark the start of an exciting two years which will see them gain extremely valuable experience both from SRC staff in these wonderful new labs in Portadown and on the job training with our scientists at Almac.

“We believe initiatives like this are vital to ensure our workforce has the right skills for the future as we continue to expand our services to companies across the world in the pharmaceutical and biotech sectors.”

Science has not been studied at the Portadown Campus of SRC for over a decade and the new lab will also see the introduction of science courses ranging from adult returner programmes to degree level courses in applied science.

Brian Doran, Director of Southern Regional College, commented: “Our curriculum in the next five years will be aligned to industrial requirements in the greater Craigavon area.

“We are delighted to be working with Almac, one of the leading pharmaceutical companies in the world, in delivering NVQ laboratory technician courses to Level 3 as part of the apprenticeship framework.

“This marks a significant milestone for the future delivery of science programmes in the greater Craigavon area and we look forward to taking forward our plans for the future development of science in our Portadown Campus.”

Anyone interested in finding out more about how to apply for the apprenticeships should go to www.src.ac.uk

Notes to Editors

About Almac Group

The company employs over 3,300 and is headquartered in Craigavon, Northern Ireland.USoperations are based in Pennsylvania, North Carolina and California.

About SRC

Southern Regional Collegeis the largest further and higher Education College outside ofBelfastinNorthern Ireland. With a total of six campuses across the counties ofArmaghand Down and covering four district councils, the College offers first class education and an exciting learning environment for further and higher education.

At further education level, the College offers courses from BTEC Level 1 Diplomas, through NVQs, National Diplomas and A levels. Many of these are aimed at the full time market although many of these courses are available on a part time basis also. The College also offers Apprenticeship Training programmes where students can learn valuable trades to take into the workplace.

The College takes enrolments of approximately 35,000 students each year and employs over 1,100 staff.

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Almac adds aXcess™ to its suite of services to complement clinical packaging and distribution bundle

admin — Mon, 12 Mar 2012 10:49:07 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, recently enhanced their web based randomization system WebEZ™, and are relaunching the product under the new name, aXcess™ includes similar features along with enhanced functionality to improve the user experience. Like WebEZ™, aXcess™ is fully configurable, can be set up very quickly, and is cost effective. Almac’s new state of the art IVR/IWR system includes key new features such as language capabilities and data integration.

aXcess™ provides a unique alternative to using paper based or manual systems to automate patient randomization and supply chain management for small to mid sized studies. Almac’s intuitive and user-friendly aXcess™ system gives clients the full benefit of a web-based randomization system, including state of the art reporting functionalities, shorter timelines for system build, and a price point to fit tight study budgets.

“The new IVR/IWR system, aXcess™, coupled with our clinical packaging and distribution bundle gives companies who would typically utilize a paper based approach to randomization and supply chain management an alternative option. This option more effectively manages the trials our clients are conducting at a cost that works within their budgetary restrictions”, says Donna Christopher, VP of Operations.

This recently enhanced IVR/IWR system was developed to give our clients the features and functionalities they are looking for in a web-based system for the small to mid-sized studies they are conducting.

For further information on aXcess™ or to request a demo please click here.

Notes to Editors

About Almac

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland.US operations are based inPennsylvania, North Carolina and California.

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Almac expands in US with addition of Commercial Packaging facility in Audubon

admin — Wed, 07 Mar 2012 10:45:03 +0000

Having identified a business need in the US for a flexible and high quality commercial packaging service provider, the Pharma Services business unit of Almac is proud to expand its established commercial packaging operations with a $10m investment in a new state-of-the-art 100,000ft² commercial facility in Audubon, PA.

Bringing more than 30 years’ commercial packaging experience from its MHRA/FDA approved UK facilities and having established a reputation for delivering high quality, reliable and cost-effective commercial packaging solutions, clients can now leverage this expertise from a local US based operation.

David Downey, VP Commercial Operations said, “Addressing the communicated needs of our Clients, we have taken the strategic step of establishing a US based operation for commercial packaging services. For many years we have been bulk manufacturing and packaging US products from our UK facility. With the addition of the Audubon facility, we will now be able to offer these packaging services local to the US market place, providing cost saving and mitigating supply risks”.

Following completion of the evaluation and feasibility design work, refurbishment of the facility has commenced and systems handover is scheduled for Fall 2012.

Upon FDA approval, Almac will offer commercial primary and secondary packaging of tablets and capsules into bottles, blisters, wallets and hospital unit dose formats along with secondary labeling and packaging of biopharmaceutical presentations such as vials and ampoules. Complementing these services are dedicated teams in pack design & artwork management and in-house tooling fabrication. Significant warehousing in ambient, refrigerated and controlled drug storage completes the services offering.

Graeme McBurney, President & Managing Director, Almac Pharma Services said, “We are delighted to be able to invest in new facilities and establish operations in the US. With the alignment of our packaging processes at both our UK and US sites, we offer the highest levels of customer service and continuity of supply, through a flexible and quality lead operation”.

Notes to Editors

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Almac Boosts Capacity and Productivity with Acquisition of New Encapsulation Equipment

admin — Tue, 28 Feb 2012 09:12:20 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, has addressed a surge in clinical outsourcing by acquiring two new pieces of encapsulation equipment at their North American headquarters in Souderton, PA. The Bosch GKF 702 capsule filler with integrated KKE 1700 checkweigher comes as a significant investment for the company close to the one year anniversary of the US headquarters’ grand opening.

The acquisition gives added value to the already impressive array of over-encapsulation capabilities offered by the global service provider as part of a complete clinical supply chain management portfolio. The Bosch cGMP-compliant system is able to produce 42,000 capsules per hour compared to the 2,700-4,500 output of Almac’s current machine in the United States. Further capabilities of the new equipment include powder, pellet, tablet, and placebo fill as well as multi-fill. The addition now creates balance between Almac’s EU and US sites by providing the same capacity to handle large and smaller scale projects simultaneously.

“This level of investment in encapsulation technology allows us to expand our capacity within our core services and shows our commitment to our clients,” says Dan Megill, Director of Operations at Almac. “Bosch was chosen by Almac because they are a leader in capsule filling and weighing equipment with a variety of options. We are extremely pleased with this acquisition and expect it to contribute greatly to Almac’s overall productivity.”

The KKE 1700 checkweighing machinery strengthens the acquisition by offering comprehensive documentation of the production batches, optimal pharmaceutical security, and a high degree of productivity.

The GKF 702 with its upgraded performance builds on the success of the previous GKF 701 model and the machine offers many advantages for research and development. The machine’s modular design offers the possibility to retrofit any future filling needs and all new filling stations currently in development will be compatible with this machine type.

For more information on Almac’s service capabilities, visit almacgroup.com. Further information about Bosch Packaging Technology is available online at www.bosch.com and www.bosch-press.com.

Notes to Editors

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selectAZyme™ grows into metabolite synthesis

admin — Mon, 13 Feb 2012 09:10:24 +0000

The biocatalyst group at Almac has doubled in size in the last year and is reaping rewards with major business growth in chiral building block supply, evolution and commercial manufacture projects as well as metabolite synthesis.

“Biocatalysis is now Almac’s first choice for any scale-up chemistry involving chirality resulting in cheaper, cleaner and robust processes” says Head of Biocatalysis, Dr. Tom Moody.

Metabolite synthesis is another tool within the selectAZyme^TM service offering that Almac has developed significantly in recent years, providing access to both oxidative and glycosylated products. Recombinant and microbial P₄₅₀ and glycosylating technology have been developed for accessing metabolites at mg to 100s grams scale. These enzymes mimic human systems and are a powerful tool for accessing metabolites rapidly and efficiently, typically in one step from the parent API.

Almac’s biocatalyst technology platform is well represented by the green selectAZyme^TM logo emphasising the “green” credentials the technology offers, from medicinal chemistry scaffold and metabolite synthesis through to commercial manufacture.

The application of biocatalysis results in reduced energy costs, lowered impact on the environment and efficient multi-tonne processing in timelines comparable to traditional chemistry.

Future plans involve discovery and development of novel P₄₅₀ and transaminase enzymes using metagenomic techniques which will significantly enhance and differentiate the portfolio of enzymes currently available to Almac and its customers.

If your process requires “greening” up, contact Almac’s biocatalysis group.

Almac will be exhibiting at the forthcoming Informex trade show, 14 – 17 February at Booth 2001.

Notes to Editors

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

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One Year On…Almac Doubles Analytical Capacity in US Headquarters

admin — Thu, 09 Feb 2012 09:06:43 +0000

Almac is pleased to announce the doubling of analytical capacity at its 240,000 sq. ft. North American Headquarters. The facility, built on a 40 acre site in Souderton, PA, north of Philadelphia, and occupied since 2010, delivers full-service, integrated clinical packaging, drug supply management and technology solutions to pharmaceutical and biotech clients. The facility boasts state of the art analytical labs, supplementing existing facilities in the UK.

The analytical labs provide support for clinical packaging operations as well as stand-alone analytical services and are equipped with the latest equipment, including HPLC, UPLC, GC, UV, IR, DSC, KF and others. The additional lab investment will continue to offer these services as well as polymorph and salt screening and solid form development.

In continuing its investment, the new lab will also be equipped with the latest bathless dissolution apparatus for rapid and efficient comparative dissolution studies. This provides maximum flexibility for developing, validating and running assay, dissolution and stability methods, further complementing the large capacity stability chambers which provide all the required ICH stability conditions.

Dr. Aeri Park, Operations Director commented: ‘”We always anticipated growth within our facility and are delighted that it has become necessary so quickly. This is testament to the dedication and commitment of our analytical team and we very much look forward to continued growth, coupled with superlative customer service in supporting clinical packaging operations and our stand-alone analytical and solid form businesses.”

The analytical facility complements Almac’s specialty capabilities, including biocatalysis, radiolabelling, and peptide and protein synthesis. These services are all part of Almac’s comprehensive drug development services, including API and drug product development and GMP manufacture.

Almac will be exhibiting at the forthcoming Informex trade show, 14 – 17 February at Booth 2001.

Notes to Editors

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Almac announce launch of Next Generation Sequencing (NGS) Data Analysis Services

admin — Wed, 01 Feb 2012 09:09:57 +0000

CRAIGAVON, NORTHERN IRELAND, 24 January 2012 – Almac’s Diagnostic Services business unit today announced launch of its advanced Next Generation Sequencing (NGS) data Analysis services.

These latest enhancements to Almac’s service portfolio include a comprehensive range of NGS solutions from professional study design to sample processing and expert data analysis for DNA and RNA samples. Uniquely, the services are highly customizable and are available on a standalone basis or in combination with Almac’s established bioinformatics offerings in the areas of biological analysis, biomarker and drug discovery and development and diagnostic product development. Almac will utilize the latest sequencing technologies and most sophisticated modern computational analysis techniques to ensure optimal results from customer data.

The solutions are delivered through a large and experienced bioinformatics team from a wide range of disciplines including biology, medicine, mathematics and biostatistics. In addition to the team’s expertise in bioinformatics and biostatistics they also have substantial experience in molecular and cell biology, drug discovery and development, and diagnostic product development.

Michael Sloan, Vice President of Business Development for Almac said:

“NGS is a rapidly maturing technology that continues to demonstrate significant benefits over traditional methods as well as making substantial steps toward routine use in the clinical setting. By expanding our services to include this range of DNA and RNA-Seq analysis we are empowering our customers with the most cutting edge technologies, opening new avenues within their research and boosting the potential for advancement of human health in a variety of disease settings”.

Almac’s NGS services build upon long standing expertise in the application of cutting edge technology to the improvement of human health.

Notes to Editors

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

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Almac Celebrates MHRA Audit Successes

admin — Mon, 23 Jan 2012 09:21:21 +0000

Almac’s Sciences Business Unit has achieved dual success in MHRA inspections at both their Craigavon Headquarters, Northern Ireland and Elvingston, Scotland sites. Both inspections were the first biennial audits to confirm continued compliance with Investigation Medicinal Products (IMP) licenses and GMP certificates.

The first inspection audited Almac’s isotope chemistry facility in support of their IMP license. During the inspection, tours of the new manufacturing finishing suite and associated infrastructure, in support of the extended API facility were conducted.

Following the MHRA’s acceptance of Almac’s response report, Almac’s licence will be applicable to both radiolabelled and non-labelled IMPs.

The second inspection covered Almac’s analytical laboratory in Elvingston, Scotland, supporting its GMP certificate as a contract analytical facility. The Inspector complimented Almac’s analytical team on their professionalism and laboratory high standards. As a result of this successful audit, two GMP certificates will be issued for human and veterinary applications.

Commenting on this dual success, President and Managing Director, Stephen Barr said:

“We are delighted with the outcome of these inspections. It is reassuring to know that the value we place on our staff and facilities is recognised in this way, and adds further credibility to our wealth of experience and services we offer.”

Alan Chambers, Head of Quality added,

“This success is just reward for the hard work and professionalism of the radiolabelling and analytical teams at both of our sites. We can all take pride in the success of these audits and their positive affirmation of the quality system to which all staff at Almac contribute.”

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

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MGB Biopharma and Almac Collaborate on Contract Manufacturing Project

admin — Tue, 17 Jan 2012 09:45:29 +0000

MGB Biopharma and Almac’s Sciences Business Unit have entered into a collaboration where Almac will manufacture the production of their lead gram positive antibacterial compound MGB-BP3.

The compound is a DNA minor groove binder and is currently in pre-clinical development with IND filing targeted for Q3 2012. CEO Dr Miroslav Ravic said “We were very quickly impressed with the approach taken by Almac and they have already shown an intuitive understanding of what it takes to support a small company like ours. We look forward to a continued successful relationship”.

Rick Dyer, VP Operations, Almac further commented “Almac has a wealth of expertise in early phase clinical development and we are delighted to undertake this phase of work for MGB Biopharma and hope this is the first of many successful projects between our companies.”

Following on from their expertise in early phase and steady growth in late phase clinical development, Almac recently announced a capacity expansion within its API facility, further leveraging its API and Drug Product integrated offering. This expansion will allow Almac to continue its commitment to deliver high quality API at competitive prices to its customers.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors

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Almac strengthens Board with appointment of new Financial Director

admin — Wed, 11 Jan 2012 09:15:11 +0000

The Almac Board is delighted to announce the appointment of Kevin Stephens to the executive position of Finance Director, Almac Group, with effect from 1 January 2012.

Kevin will take responsibility for all financial aspects of Almac Group activities globally, leading the financial management teams for all global operations, supporting the planned growth of the business and co-ordinating financial control and reporting throughout the Group.

After graduating from Queen’s University, Belfast, with a degree in Economics, Kevin qualified as a Chartered Accountant with Ernst & Young and then worked for 14 years with Kemira NI as Financial Controller.

Kevin joined the Group in 2001 and following a number of varied financial roles within the organisation. , was appointed to the position of Almac UK Group Financial Controller in January 2007. He was promoted to the role of VP Finance, Almac Group, in July 2009, and subsequently in October 2010 was appointed to the Almac Executive team as Executive VP Finance, Almac Group.

Alan Armstrong, CEO of the Almac Group commented: “We are delighted to appoint Kevin to this important financial position on our Board. Not only does he possess strong financial qualifications and training, he also has very specific knowledge and experience of the workings of the Almac Group having held a string of financial positions within the organisation. Indeed, we anticipate that Kevin will play a key strategic role in the continued growth and successful financial management of our Group of companies.”

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors

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New building will help Almac serve customers from Argentina to Zimbabwe

admin — Mon, 09 Jan 2012 12:24:31 +0000

Almac has opened a new £3m building at its Craigavon headquarters from which staff will provide services to customers in over 100 countries around the world.

Around 150 staff who work for Almac’s Clinical Services Business Unit have just moved to the new 30,000 sq ft building to consolidate its services.

Staff working in the pharmaceutical development company’s new offices will co-ordinate and manage the processes involved in packaging and distribution of medicinal supplies for clinical studies carried out as far afield as Argentina to Zimbabwe.

Many of the staff are clinical Project Managers and Project Co-ordinators, managing studies on behalf of world-leading pharmaceutical and biotechnology companies. Business Development, Marketing, Human Resources and Information Systems departments are also based in the new building.

Celine Bradley, Global VP of Operations said: “This addition to Almac’s continuously expanding headquarters brings together staff who have been working from different facilities on site for the past few years.

“Almac’s project staff manage clinical studies all around the world, providing cutting edge services that enhance the global clinical supply chain and contribute to the ethical goal of getting new treatments into the market faster

“Investment in our staff, state of the art global facilities and ongoing delivery of innovative services positions Almac as the premium provider of clinical trial supply chain solutions.”

Carrying out the clinical studies requires specific manufacture, packaging and labelling to prepare bespoke packs for distribution around the world. The company is constantly reviewing how to keep the drugs safe using its unique systems to monitor temperature conditions during transit and cut wastage. Over 90% of Almac’s sales come from outside the UK and its global supply network now extends into 32 countries and 37 depots.

Ends

Notes to Editors

About Almac

The company employs around 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new North American Headquarters located in Souderton PA.

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Almac’s Diagnostic Laboratory Receives Accreditation from College of American Pathologists

admin — Wed, 30 Nov 2011 09:08:46 +0000

Almac’s Diagnostic Services business unit has been awarded accreditation for its Craigavon, UK facilities by the Accreditation Committee of the College of American Pathologists (CAP), based on the results of a recent onsite inspection.

The laboratory’s director, Richard Kennedy, MBChB, PhD, was advised of the national recognition and congratulated for the excellence of the service provided by Almac.

The CAP Laboratory Accreditation Program commenced in the early 1960s and is recognized by the federal government as being equal to or more stringent than the government’s own inspection program.

During the CAP accreditation process, inspectors examine the laboratory’s records and quality control of procedures for the preceding two years. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and the overall management of the lab. This stringent inspection program is designed to specifically ensure the highest standard of care for all laboratory patients.

President and Managing Director, Professor Paul Harkin commented on the achievement “This accreditation allows us to further support our clients by running clinical diagnostic tests for trial enrichment. This is of increasing importance to our clients and constitutes an important part of our biomarker services”.

Notes to Editors:

About Almac:

The company employs over 3,300 individuals and is headquartered inCraigavon,Northern Ireland.US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new North American Headquarters located in Souderton PA.

About the College of American Pathologists:

The College of American Pathologists (CAP), celebrating 50 years as the gold standard in laboratory accreditation, is a medical society that serves more than 17,000 physician members and the global laboratory community. It is the world’s largest association composed exclusively of Board-certified pathologists and is the worldwide leader in laboratory quality assurance. The College advocates accountable, high-quality, and cost-effective patient care. More information about the College can be found at www.cap.org.

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Almac extends helping hand to local charities

admin — Tue, 29 Nov 2011 11:31:02 +0000

Craigavon-based company Almac has made donations totalling £12,500 to charities which help local people who are terminally ill.

The money was raised at the pharmaceutical development company’s annual ‘Event in the Tent’, which sees a giant marquee erected at its headquarters to hold a social event recognising staff’s achievements and successes.

This year it was attended by a record 1,300 staff who bought ballot tickets to win prizes, with all proceeds going to the local charities.

This year’s beneficiaries were Marie Curie Cancer Care and the Northern Ireland Hospice.

The Marie Curie Nursing Service makes it possible for people with terminal illnesses who want to be cared for at home at the end of their lives to have that choice.

Northern Ireland Hospice provides respite and end-of-life care for children, young people and adults with life-limiting and life-threatening conditions such as cancer, heart disease, muscular dystrophy and neurological conditions.

Ciara Gallagher, fundraising manager, Marie Curie, said: “We spend the money we raise locally on providing end of life care for patients with cancer and other terminal illnesses in the community and at the Marie Curie Hospice, Belfast.

“Throughout Northern Ireland Marie Curie nurses work in the community providing care, totally free for patients in their own homes and last year cared for 1,613 patients. For every £20 we raise the charity can provide one hour of nursing care.

“The money raised by Almac will fund over 300 hours of nursing care in the Southern Area which covers Craigavon, Portadown, Lurgan and Dungannon.”

Receiving the cheque on behalf of Northern Ireland Hospice, Evelyn Uprichard, Hospice Nurse Specialist, said: “We are delighted to receive this very generous donation from Almac. It will make such a difference to the 3,000 local children, young people and adults with a life-limiting or life-threatening condition that we help each year.

“Every year Northern Ireland Hospice has to raise over £5.5 million through voluntary donations to provide our specialist nursing care in the home and in hospice, and we could not do this without the continued support of local businesses like Almac.”

Alan Armstrong, CEO of the Almac Group, said: “Our annual ‘Event in the Tent’ which has been running for seven years always has a strong charity angle which is well-supported by our staff.

“Since 2006 we have raised well over £50,000 for a wide range of local charities including the Northern Ireland Chest Heart & Stroke Association, NI Cancer Fund for Children, Belfast City Hospital, Southern Area Hospice and Macmillan Cancer Fund. Our sincere thanks go to our many suppliers for the kind generosity in once again supplying the prizes for the draw.

“The event is our way of recognising the efforts of our team and we are so pleased that the money raised will go towards caring for people who are terminally ill.”

Notes to Editors

About Almac

For more information about Almac contact Jane Wells or Andrea Clements at JPR on 028 9076 0066.

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Almac Shines At Awards Ceremonies

admin — Mon, 28 Nov 2011 15:31:56 +0000

Almac’s Clinical Services business unit is celebrating having picked up three top accolades in the recent NI Chamber of Commerce Awards and The Chartered Institute of Marketing (CIM), Ireland, Marketing Excellence Awards. These latest achievements mark the end of a highly successful year for the NI Company who also won the Business of the Year at the BMI / Belfast Telegraph Awards earlier in the year. Almac was recognised for its continued excellence in the field of contract drug development and manufacturing within the biotechnology and pharmaceutical sectors, in which the company is globally renowned as a world class services provider. This year, Almac has again gone from strength-to-strength growing significantly despite the challenging economic environment. The Company is now successfully delivering critical patient medication to over 100 countries globally.

NI Chamber of Commerce Awards

In the recent NI Chamber of Commerce Awards, Almac Clinical Services picked up two prizes – Business of the Year and the Award for Innovation through Technology for an award submission based on their Shipping Temperature Electronic Monitoring System – STEMS. This was designed to improve the efficiency of the monitoring process of temperature sensitive clinical trial supplies during the distribution process. The awards are sponsored by high profile companies including RBS and NatWest, BT Business, BT Directories, Dell, the British Standards Institution (BSI), AXA PPP healthcare and Westfield Health who were involved in selecting the winners.

CIM Ireland Marketing Excellence Awards 2011

At a distinguished awards ceremony held at the City Hall, Belfast– Almac’s Clinical Services business unit received an award for Marketing Excellence within the Chemicals, Plastics and Pharmaceuticals sector in the centenary year of The Chartered Institute of Marketing Ireland, Marketing Excellence Awards 2011. The event which attracted more than 400 guests celebrated the remarkable achievements of the marketing profession across the island of Ireland.

Commenting on these recent achievements, Martin Lamb, Vice President of Business Development, Almac Clinical Services ‘We are delighted to have won these awards which recognise again the contribution Almac has made to the local NI Business Community in creating employment and supporting the local economy. Almac is one of Northern Ireland’s major success stories and we are honoured to receive these awards which reflect the hard work of all our employees across all disciplines & sites – fundamental to our success.”

The Almac Clinical Services Team pictured at the CIM Ireland Marketing Excellence Awards where they picked up the Award for Marketing Excellence within the Chemicals, Plastics and Pharmaceuticals sector.

Left – Right – Peter Sanford, Nicholas Griffin, Winnie McKeag, Laura Clarke, Maire Mullin, Jonathan Calderwood, Aileen Murphy, Paul Costelloe (Guest Speaker), Carolyn Timpany & Barry Cathcart

Jonathan Calderwood, Global Marketing Manager receives the NI Chamber of Commerce Awards for Business of the Year and the Award for ‘Innovation through Technology’

Notes to Editors About Almac Group

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Almac Responds to Alexion’s Request for Rapid Packaging and Distribution During Public Health Crisis in Germany

admin — Mon, 21 Nov 2011 09:20:30 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, responded earlier this year to an urgent request from their client partner, Alexion Pharmaceuticals, Inc., a global biotechnology company, for packaging and distribution of Soliris® (eculizumab) for patients with STEC-HUS during the E. coli outbreak in Germany earlier this year.

Background

Beginning in May and lasting through the summer, Germany experienced a historically large outbreak of food-borne E. coli infection, which resulted in more than 800 cases of STEC-HUS (Shiga-toxin producing E. coli hemolytic uremic syndrome), an ultra-rare and life-threatening complication of the infection. As the crisis grew, Alexion initiated an access program to provide Soliris free of charge in response to requests from physicians treating patients with STEC-HUS. Subsequently, Alexion commenced a clinical study with Soliris in STEC-HUS patients, in collaboration with the German healthcare authorities and leading physicians.

Although Alexion continuously maintains more than 18 months of Soliris inventory in addition to its two manufacturing sources, the need for Soliris specifically packaged for use at various centers in Germany was greater than the normal use of Soliris for patients with paroxysmal nocturnal hemoglobinuria (PNH) in that country. Alexion contacted Almac for assistance in delivering the drug, packaged and labeled, to the EU, and requested an extremely short turnaround time to package and distribute their drug product. Soliris is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare and life-threatening blood disorder, in the U.S., European Union, Japan and other countries. Soliris is also approved for the treatment of patients with atypical hemolytic uremic syndrome (aHUS), a debilitating, ultra-rare and life-threatening genetic disorder, in the United States. The German physicians were using Soliris in STEC-HUS on an investigational basis. The study evaluating the safety and efficacy of Soliris for the treatment of patients with STEC-HUS is ongoing.

“Almac understood the importance of meeting this critical timeline to Alexion and ultimately the German patients. Because of this, the project had visibility to the highest levels at Almac and meetings were held daily to ensure that nothing was missed or allowed to cause delay,” said Donna Christopher, VP of Operations at Almac’s Durham, North Carolina facility. “This was a very gratifying collaboration for Almac to be involved in, as we were able to make an immediate impact to a highly publicized public health crisis. This was satisfying to everyone who worked on this project.”

Almac’s overall approach was to quickly process (within 48 hours) the current commercial Soliris^® drug product stock held at Craigavon, UK (licensed for the treatment of PNH – paroxysmal nocturnal hemoglobinuria) on a Named Patient basis to German physicians to treat this life threatening condition. When the initial urgent requirement was met, Almac was then able to scale up the packaging and distribution of the clinical trial product.

The product was successfully delivered to patients in the time requested due to the careful planning and constant communication of all parties involved. “Almac was very pleased to be able to deliver the drug to Germany within the timeframe,” said Robert Dunlop, President of Almac Clinical Services. “Given the nature of our industry, there are occasions when we all have to pull together to address a critical patient need. The supply of Soliris^® to patients in Germany is a great example of what can be achieved when different stakeholders combine their respective strengths for the common good.”

For more information on Almac’s capabilities, please visit almacgroup.com or email info@almacgroup.com. More information on Alexion is available at www.alexionpharma.com.

Notes to Editors About Almac Group

About Almac

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Co Tyrone woman is Almac’s 2,000th UK employee

admin — Thu, 17 Nov 2011 09:28:22 +0000

Almac has welcomed its 2,000^th UK employee after doubling its workforce in the last six years.

Ciara Cassidy, from Aughnacloy, Co Tyrone, has just taken up a position at the Craigavon-based pharmaceutical development company as an Application Support Developer.

Her job will involve constant updating of Almac’s IT systems to help it provide services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

Almac joins just a handful of local independent private companies to pass the landmark of employing more than 2,000. It also employs around 1,200 people in America, over 900 of them at its $120m North American headquarters in Souderton, Philadelphia which was officially opened in May by formerUS Senator George Mitchell. The company also employs approximately 30 people in Edinburgh and Manchester.

Although many of its employees are leading scientists, the company’s rapid expansion has also created a wide range of opportunities in non-scientific jobs.

Over the last six years Almac has experienced double digit growth year on year and last year the company created 183 new jobs. It is expected that the rate of recruitment will continue across all areas of its work in Craigavon and at its US headquarters.

Stewart Watt, Almac’s Group HR Manager UK, said: “We are extremely fortunate to be enjoying global growth at a time of economic downturn and as a result we are able to offer employment in a wide variety of high value jobs.

“Our employees work in almost 600 different roles and we are constantly searching for talented staff to ensure our business success continues on both sides of the Atlantic.

“We have extremely low rates of staff turnover so the opportunities being provided are brand new jobs. At any one time our recruitment staff are working on filling up to 120 vacancies.

“There is a perception among some people that you need a scientific background to join Almac but for many of our jobs this is not the case. We currently have opportunities in information services, production manufacturing, engineering, quality and project management as well as HR and legal positions.”

Almac, which was founded by the late Sir Allen McClay in 2002, has more than doubled both its staff numbers and turnover since 2005.

Among its products and services are genomics, chemical development, manufacture, packaging, labelling, management and global distribution of clinical medication packs and commercial products. .

Notes to Editors

About Almac

The company employs over 3,300 individuals and is headquartered inCraigavon,Northern Ireland. US operations are based inPennsylvania,North CarolinaandCalifornia. Almac has now moved into its new North American Headquarters located in Souderton PA.

For more information about Almac contact Jane Wells or Andrea Clements at JPR on 028 9076 0066.

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Almac publishes Stage II colon cancer recurrence signature in the Journal of Clinical Oncology

admin — Tue, 08 Nov 2011 09:05:47 +0000

CRAIGAVON, NORTHERN IRELAND, 07 November 2011 – Almac’s Diagnostic Services business unit today announced the publication of its stage II colon cancer recurrence signature (diagnostic test) in the Journal of Clinical Oncology.

The article entitled “Development and Independent Validation of a Prognostic Assay for Stage II Colon Cancer Using Formalin-Fixed Paraffin-Embedded Tissue” gives detail on the development and validation of a prognostic gene signature in Stage II colon cancer.

Colon Cancer is the third most common cancer in the United States with over 101,000 cases diagnosed per year.

Current clinical guidelines for patients presenting with stage II colon cancer recommend treatment with surgery alone. This is effective for around 80% of patients, however 20% of the patients will experience recurrence of the disease and for these patients there may be benefit in offering adjuvant chemotherapy. The Almac test will identify those patients that have higher risk of disease recurrence, providing valuable information to the Oncologist to support their further treatment decisions

Most prognostic factors routinely used in the clinic do not exceed a HR of 1.5. The Almac developed test gives a hazard ratio of 2.53 with a p-value of <0.001. The signature has also been shown to be independent of other prognostic factors.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic business unit and Professor of Molecular Oncology at Queens University Belfast said:

“The stage II ColDx test represents a significant breakthrough in colon cancer management. We believe that this test will change clinical practice and benefit cancer patients.”

The test has been developed and validated exclusively using formalin fixed paraffin embedded (FFPE) tissue using Almac’s own proprietary Colorectal Cancer DSA^®.

Professor Patrick Johnston, Dean, School of Medicine, Dentistry and Biomedical Sciences at Queen’s, said:

“We are pleased to have been able to play a role in helping Almac to develop this groundbreaking technology which we hope could save many lives in the future. Both Queen’s and Almac are working tirelessly in advancing cancer research and treatments.”

The signature is currently undergoing a final external validation study and will be available to patients in 2012.

Notes to Editors

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Almac’s rapidd continuing to accelerate early stage development 2 years on

admin — Tue, 25 Oct 2011 08:54:14 +0000

October 2009 saw Almac launch an integrated early development service, rapidd^TM, to address the issues of time, cost and attrition in early clinical candidate development by taking a lead drug development candidate to Phase I regulatory submission in under 12 months. Two years on, Almac are pleased to report strong demand for the early stage development package.

rapidd^TM works by offering a lean, flexible package, fully compliant with ICH guidelines, and integrated services between Almac and selected global CROs which is managed by Almac through a dedicated programme management team.

In 2011 alone, three integrated programmes have been completed with a further 5 ongoing, or in late planning stages. Over the past two years, interest has remained strong in both the NCE and biopharmaceutical markets from a range of clients from virtual biotech companies to large pharma with both small molecule and peptide candidates.

“rapidd^TMenables our clients to make significant savings against conventional lead times from careful programme optimisation and avoidance of tech transfer time and other common issues which arise in a multiple partner process”, commented Denis Geffroy, VP Business Development. “We are delighted that our rapidd^TMprogramme has proven so successful in helping to eliminate these barriers. With our range of single-site services and capabilities, we are confident that our package brings even more added value in our clients’ pre-clinical development programmes.”

In the current uncertain financial climate, Almac’s clients have benefited from the flexible approach rapidd^TM offers – from taking advantage of Almac’s pre-clinical expertise to enabling payment schedules to be structured in line with agreed investor milestone payments.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

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Almac Invests in New Commercial API Manufacturing

admin — Mon, 24 Oct 2011 08:35:41 +0000

In order to satisfy increasing demands, Almac are expanding their manufacturing capacity to over 30m³ at its European Headquarters in Craigavon, UK. The upgraded facility will include reactor vessels with state of the art clean room product isolation and drying equipment to allow Highly Potent API manufacture up to 600kg batch size.

With currently 6 API and advanced chiral intermediates in Phase III clinical development, Almac has steadily increased its market penetration in late phase clinical development, leveraging its API and Drug Product Integrated offering. This major expansion will allow Almac to continue its commitment to deliver high quality API at competitive prices to its customers. Denis Geffroy, VP Business Development stated: “We are delighted with the progress made over the past 2 years to increase our presence in late phase clinical development. This capacity increase will allow a smooth transition from late phase clinical development to full commercialisation. Scale was becoming a limiting factor for some of our client projects and this new capacity is a strong commitment to offer project continuity. It opens up a new chapter in Almac’s API manufacturing capability”

It is anticipated that the facility will be built, commissioned and validated within the next 2 years. In the meantime, Almac will continue progressing late stage manufacturing projects within their existing facilities and with a number of key supplier relationships. Dr Rick Dyer, VP Operations added, ““This expansion allows us to build on our expertise in early phase clinical development projects and further continue our success within late phase projects so clients need not transfer some of our well developed processes elsewhere due to lack of scale. This investment will further place Almac as the supplier of choice to satisfy all client requirements from preclinical phase to full commercialisation.”

Almac’s advantage of hosting all facilities on one site have led to the successful technology transfer of small molecule and peptide projects from lab development to large scale manufacture.

Additionally, the increase in chiral late stage projects is attributed to Almac’s selectAZyme^TMtechnology platform. Almac is applying their enzyme technology to customer processes resulting in shorter and more stream lined syntheses. The customer sees immediate benefits due to lower chemical and manufacturing costs as well as applying green credentials to their process which is in line with the need to minimise environmental factors. Initially launched in 2009 with the sale of six enzyme kits, Almac’s biocatalysis capabilities have expanded to the supply of 100s of kgs of both chiral intermediates and APIs. Dr Tom Moody, Head of Biocatalysis notes “Biocatalysis is now recognised as a premier solution for solving complex chemistry problems due to its rapid implementation, economic benefits and “green” reputation. It is the technology of choice for chiral chemistry within Almac.”

Using selectAZyme^TM technology as opposed to conventional routes to APIs has significantly improved yields, productivity and timelines for multi-step syntheses. Denis Geffroy further commented, “We believe that our biocatalysis offering is unique within the marketplace and when coupled with our skills and expertise in synthetic chemistry, it opens immediate benefits to our customer projects. Our growth in this area, coupled with our planned facility expansion will give our clients maximum opportunity for success in their product development projects.”

For further information, Almac will be exhibiting at the forthcoming CPhI (Booth 41C18) and AAPS (Booth 2837) conferences.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

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Almac Invests £1M in Dedicated Mass Spectrometry Laboratory

admin — Fri, 21 Oct 2011 09:08:29 +0000

Almac has established a dedicated mass spectrometry laboratory in their European Headquarters, Craigavon, UK.

The £1M facility houses state-of-the-art mass spectrometers and underlines Almac’s commitment to providing the best analytical facilities for its customers. The investment of this laboratory and instruments substantially increases the company’s capabilities in solving complex analytical challenges. Instrumentation includes Quadrupole Time of Flight and Triple Quadrupole spectrometers for accurate mass and quantitation work.

With this dedicated facility, clients can now benefit from an extended range of mass spectrometry services, including the quantitation of genotoxic impurities, bioanalysis, structure elucidation, isotopic purity determinations and high resolution mass spectrometry of both small and large molecules.

Jon Cook, Head of Analytical Chemistry commented “This new mass spectrometry facility reinforces Almac’s vision of delivering the best for our customers and substantially enhances the level and depth of services we can provide.”

Paul Desmond, Analytical Manager added “We are delighted with this investment – whilst customer focus is always our priority, we are confident that the enhanced services offered within our facility, will benefit our clients further.”

Agilent Technologies were chosen as the preferred vendor to supply the suite of Mass Spectrometers to Almac. Agilent Technologies are a company of innovation, that deliver high quality products and technical solutions which will help enable Almac meet their clients expanding analytical requirements.

Declan Murray, Sales Manager noted “Agilent Technologies are delighted to be part of setting up such an important new Mass Spectrometry Laboratory in Almac. Agilent have a long relationship with Almac and the new MS facility merely builds and strengthens this relationship further.”

For further information, Almac will be exhibiting at the forthcoming CPhI (Booth 41C18) and AAPS (Booth 2837) conferences.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

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Almac Announces Expansion of Pharmaceutical Development Facilities

admin — Thu, 20 Oct 2011 09:13:34 +0000

Almac is pleased to announce the expansion of our Pharmaceutical Development services with the creation of a new facility at our UK headquarters in Craigavon.

With an initial investment of £4.5million, phase one of the expansion will provide a state-of-the-art, non-GMP formulation development facility for the development and scale-up of solid oral dose drug products using a broad range of technologies.

The new formulation development suites will complement Almac’s existing pharmaceutical development facilities and will include high levels of control over environmental conditions as well as extending current capabilities in processing high-potent compounds with OEL’s as low as 0.03μg/m³.

The current GMP development facilities focus on drug products up to pilot scale & registration, whereas, the new facility will operate at lab-scale, with batch sizes for most technologies typically expected to be less than 15 kg scale.

John McQuaid, VP of Technical Operations explains “Almac’s intention is to ensure that there is a seamless transition between development and GMP phases of projects in early stage clinical development. Additionally the scale we have chosen will support the growing area of process DoE studies for candidates in late stage development.”

Phase two of the project will involve a significant expansion of GMP analytical support capabilities with the construction of 2 additional QC laboratories within the new facility.

“The new facilities will effectively double our current pharmaceutical development capacity allowing us to meet the growing demand for our services, both from existing and new clients. Recruitment of experienced formulation and analytical development staff has already commenced in support of this exciting expansion” stated McQuaid.

Phase one of the expansion is due for completion mid 2012 with Phase two of the expansion and configuration of dedicated analytical labs completing towards the end of 2012.

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Almac and Greenphire Form Alliance to Deliver Direct-to-Patient Stipend Payments Through IXRS®

admin — Wed, 05 Oct 2011 09:33:06 +0000

The Almac Group and Greenphire announced today that Almac’s Clinical Technologies business unit, the leading provider of IXRS^®(Interactive Voice and Web Response) services relating to patient and drug supply management, has formed an exclusive alliance with Greenphire to offer joint services relating to patient payment administration for clinical trials. This new service improves current methods of manual patient payment management and alleviates administrative burden on personnel in biopharmaceutical companies and Contract Research Organizations (CROs), allowing them to focus on more study-specific responsibilities.

Greenphire has worked with Almac to seamlessly incorporate its ClinCard System, a market-leading patient payment management suite of technologies, with Almac’s IXRS^®system, an integrated phone and web platform. This unique industry offering provides patients with direct and timely compensation via a branded debit card. After patients complete required study-related tasks and responsibilities (e.g. attending site visits), their debit card is automatically and immediately credited with the appropriate stipend or reimbursement amount.

The Almac-Greenphire alliance provides several benefits to biopharmaceutical companies. The integrated platform improves operational efficiency, decreases sponsor, site and CRO administrative burden, reduces payment administration costs and timelines, and increases site and patient satisfaction. Research indicates that compensation is one of several important factors that drive patient compliance and eagerness to participate in clinical trials.

Almac President, Jim Murphy comments on the alliance with Greenphire: “Our customers are increasingly looking to Almac to help them find ways of improving patient management and compliance during clinical trials. Partnering with Greenphire enhances Almac’s suite of patient-centric services by offering direct-to-patient payments to subjects enrolled in clinical trials. This new joint service allows Almac to more efficiently manage patient payments and tie them closely to key study milestones through our IXRS^® technology.”

From Greenphire’s perspective, the strategic partnership with Almac establishes another integrated platform through which the ClinCard System delivers value to pharmaceutical, biotech, and medical device companies. Building on Greenphire’s prior integrations with leading web-based clinical platforms, the ClinCard System will be seamlessly customized to deliver, track, and report patient payments through Almac’s existing IXRS^®workflow. As an alternative to manual, paper-based payment management processes, the ClinCard System offers real-time, secure, and easily accessible patient stipend and reimbursement payments.

Greenphire CEO, Sam Whitaker expressed his enthusiasm with the landmark Almac partnership, saying “Our strategic partnership is groundbreaking. Greenphire’s technology has had a significant impact on driving efficiency to all of the key organizations responsible for executing study operations. Our integrated functionality with Almac not only increases the value to Greenphire’s current ClinCard offering, but also drives clinical operational efficiencies which new clients could never have achieved in the past.”

Almac and Greenphire will be featuring a demo of their integrated services at upcoming conferences and trade shows in 2011-12.

Notes to Editors

The company employs over 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new North American Headquarters located in Souderton PA.

Almac’s Clinical Technologies business unit specializes in interactive technology and service solutions to increase the quality and efficiency of clinical trials. Solutions include Interactive Voice and Web Response Systems (IXRS^®) for patient randomization and drug assignment, patient and clinical supplies management, electronic-patient-reported-outcomes data collection, patient compliance, and Web drug reconciliation. Almac’s technologies have been deployed in over 1700 clinical trials, incorporating over 1.6 million patients in over 80 countries, and more than 50 languages.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

About Greenphire

Greenphire’s clinical payment and communication solutions take a patient-centric and site-centric approach to driving data integrity and data completeness for sponsor, CRO, research university, and clinical research site clients. Greenphire’s web-based technologies are designed to improve the clinical experience for patients and sites, drive positive patient behavior, increase patient retention and compliance, and significantly reduce site and study team administration associated with patient payments and communication. Greenphire’s strategy is driven by the philosophy that empowered, satisfied patients and sites will deliver more consistent and better quality clinical data, which will in turn benefit both site coordinators and study teams. Learn more about Greenphire’s innovative clinical solutions at www.greenphire.com.

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Almac flies the flag for European Day of Languages

admin — Fri, 23 Sep 2011 14:32:16 +0000

Craigavon-based pharmaceutical development company Almac is celebrating the cultural and linguistic diversity of its employees today, European Day of Languages, (Monday September 26).

No fewer than 17 European languages including Finnish, Czech and Greek are spoken by staff in the company’s workforce of almost 2,000 in Northern Ireland and at the last count staff spoke a total of 31 world languages ranging from Japanese to Gujarati and Marathi. Many other languages are used by its employees on its sites in Pennsylvania, North Carolina, California and Edinburgh.

On a visit to Almac’s Craigavon site to mark European Day of Languages, MEP Jim Nicholson, said: “As a global leader in the biopharmaceutical industry Almac is attracting top talent from across the world as well as employing many of Northern Ireland’s leading scientists and businesspeople.

“Employing such a diverse range of local and international staff including those from a wide range of EU countries is paying dividends for Almac as it grows year on year, supporting and encouraging research and innovation in the field of healthcare.

“Although it is a world renowned company Almac has always retained a strong focus on contributing positively to the economy of Craigavon and Northern Ireland as a whole, providing high quality jobs for so many.”

Almac’s Chief Executive Alan Armstrong said: “People come from all over the world to work at Almac’s Craigavon site in a wide range of jobs. Whilst the vast majority of our employees are still from the local community, we are thrilled to have people of 31 nationalities among our workforce in Northern Ireland.

“Having such a culturally and linguistically diverse workforce is a great strength for Almac’s global business.

“While we live in a world that is instantly connected at the touch of the keyboard the ability to respect and appreciate different cultures and languages is vital to business success.”

Today marks the 10^th anniversary of European Day of Languages. The event has been growing every year since 2001 following a decision by the Council of Europe to declare the day to be celebrated on September 26.

The idea behind the event is to raise public awareness of all the languages spoken in Europe and the importance of language learning in spreading tolerance and mutual understanding. The European Day of Languages celebrates linguistic diversity as one of Europe’s strengths, and encourages lifelong language learning.

Notes to Editors

The company employs over 3,000 and is headquartered in Craigavon, Northern Ireland. Its North American Headquarters are in Souderton, Pennsylvania and the company also has sites at North Carolina and California.

For more information about Almac contact Jane Wells or Andrea Clements at JPR on 028 9076 0066. Jane.wells@jprni.com, 07860 288 860

Andrea.clements@jprni.com, 07808

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Almac takes a clinical approach – Almac CEO Alan Armstrong talks about the firm’s continuing expansion

admin — Thu, 08 Sep 2011 12:00:48 +0000

Ulster Business: – Northern Ireland’s Top 100 Companies by Symon Ross

Almac is regularly, and rightly, lauded as one of Northern Ireland’s business success stories.

It is the perfect example of the type of innovation-led export company which political and business leaders know the province will need more of if we are to reduce reliance on the public sector and create a knowledge economy.

The company provides a range of services extending from research through pharmaceutical and clinical development to commercialisation of products for more than 600 global clients.

Its history dates back to 1968 when the late Sir Allen McClay founded his original company Galen Ltd, which marketed and sold ethical pharmaceutical products in the UK and Ireland.

Through the years the company formed specialist divisions for Pharmaceutical Development & Manufacturing Services, Clinical Trial Services, Chemical Synthesis Services and Interactive Clinical Technologies Incorporated and a separate company Almac Diagnostic Services.

During 1997 Galen undertook an IPO to become Galen Holdings Plc. with listings on the London and Irish markets. Sir Allen McClay then made a strategic decision to retire from Galen Holdings Plc in 2001 and personally invest approximately £240m to purchase the four service-based businesses from Galen and incorporated Almac Diagnostic Services in order to keep the company in Northern Ireland.

PwC last year provided a measure of just how important the company has become to the Craigavon area, calculating that over 20 years Almac will generate sales revenue of £5.3bn for the Northern Ireland economy. Based on its current total of 2,000 employees that figure would now rise to £6.1bn.

And yet, despite continued growth in revenues and profits, there is an understated feel about the company, stemming perhaps from the character of its late founder Sir Allen McClay, who was not one for airs and graces.

Though he passed away in January 2010, there’s still a strong sense of Sir Allen McClay’s presence around the company. At reception in Craigavon a video charting the company’s history shows footage of him receiving his knighthood. And, several times during our interview Chief Executive Alan Armstrong nods towards an empty desk in the office behind him when he refers to ‘the auld fella’.

“He had a lot of ideas and philosophies that were woven into the organisation and which remain there. We’ll do our best at senior management level to keep them there,” says Armstrong, who first joined the company 33 years ago.

Many of Almac’s directors and senior management team have been with the company since they were graduates. That has added a stability and loyalty that few other companies of its size are able to claim, and means that McClay’s vision to see Craigavon remain the firm’s headquarters and engine room has not been altered.

“There’s a sense of loyalty and a sense of belonging. Allen McClay used to talk about the Almac family and there is something to that,” agrees Armstrong.

He puts the company’s continued growth through the recession down to the hard work and professionalism of its employees, as well as having the right products for them to present to clients in the right way. Almac employs a broad range of local graduates, and recruits more specialist roles from around the world.

It also counts all of the world’s major pharmaceutical firms and hundreds of biotech companies as clients.

But it is not resting on its laurels. Armstrong says R&D and innovation are the only way it can keep its competitive edge and this requires constant investment.

“The beauty of this organisation is that any surplus cash that’s generated, there’s no venture capital organisation or shareholders to look after. It’s all ploughed back into the business.

It is used to build buildings and buy equipment, all sorts of development work to make the business more sustainable and more profitable,” he said.

EXPANSION

Earlier this year Almac officially opened its North American headquarters in Souderton, Pennsylvania – a state-of-the-art facility that represented an investment of $120m and which houses more than 800 employees.

The decision to open a new facility came after Almac outgrew its facilities in Audubon and Yeardley. Rather than extending either of those it took the plunge to invest in a new 240,000 sq ft building on the basis that the business was expected to keep growing. With low greenhouse gas emissions and a water reclamation programme, the management feel the building reflects the cutting edge reputation of the company.

“It is a terrific facility, world class, well designed, well built and we’re proud of it. It came in on time and on budget,” says Armstrong.

“We tried to make it as similar to Craigavon as we could, to get the same look and feel as we have here just so there is some continuity for staff and customers,” he adds.

“Everyone knows the North American market is a huge market. You need to be seen to be a real player. We sent a message to our customers and our competitors that we are here and we are here to stay. It is a meaningful landmark.”

Almac’s divisions distribute products and services around the world, and the company’s goal is to add around 15 new customers every year.

It estimates that well over 90 per cent of its business is repeat business – showing, the CEO says, that if you are reliable and have the trust of your clients you don’t always have to be the cheapest in the market.

“That’s a big indicator of how well we are doing. Because if you’re doing a bad job customers won’t come back,” says Armstrong. Keen perhaps not to blow Almac’s own trumpet too much, he adds quickly: “We’re doing okay. You’re better not to get too big headed, but we’re doing alright.”

Armstrong believes the firm would do even better should the long discussed powers to lower corporation tax be devolved to Northern Ireland.

Sir Allen McClay was quoted as saying that a lower corporation tax rate in Northern Ireland would help him double the size of his business within 10 years. The company’s CEO is still happy to have that statement quoted.

“Lower corporation tax means we have more cash to invest back into the business and that is where it will go. There’s a knock on effect in that, if we’re employing more people, we require more packaging material, more buildings, more facilities and that all creates wealth in the economy,” he explains.

“If there’s not a sea change of some sort, the future is not terribly bright for Northern Ireland.”

THE FUTURE

While future growth for Almac seems assured, the CEO won’t be drawn into making predictions. He sees further potential in the services areas as more companies in the sector choose to outsource their drug development work to make it happen more quickly and cheaply.

“We don’t set goals that say if we’ve got there, we’ve succeeded. New things tend to come along all the time and we have to be versatile so we can adjust to the opportunity and go for it. That happens regularly, where a new area needs formulation and development, and so we need to keep fairly flexible so we can move to wherever’s required in terms of innovation, capacity and spending cash,” he said.

There are no immediate plans to enter into the process of developing drugs from initial compound to market, a process that can cost in the region of $2bn and, even for Almac, is a bridge too far at this stage.

However, Armstrong revealed that the company has “lots of irons in the fire” in the diagnostic space and that it has also been looking at opening an office in Asia.

“If we did it would be to supplement Northern Ireland and even bring more work here because we’re a bigger outlet for it. It would be to supplement it rather than take away from it,” he adds.

The ideal way ahead is, he says, one of steady and manageable growth.

“If you grow at too quick a pace maybe aspects of your business such as quality begins to slip. We want to grow but take everyone along with us. We’re not a public company so there’s no big profit or revenue figure we have to meet in order to keep the City happy. We keep ourselves happy.”

Perhaps therein lies Almac’s secret.

The post Almac takes a clinical approach – Almac CEO Alan Armstrong talks about the firm’s continuing expansion appeared first on Almac.

Almac-Queen’s cancer expert to lead £4.4m collaboration

admin — Wed, 07 Sep 2011 10:41:11 +0000

An investment of £4.4m in a unique academic-business collaboration between pharmaceutical development company Almac and Queen’s University will help develop better tests for diagnosing and treating prostate, ovarian and breast cancer.

The research initiative, based at the Center for Cancer Research and Cell Biology (CCRCB) at Queen’s, will be led by Professor Richard Kennedy, one of Almac’s experts in personalised medicine – which tailors specific treatment to each cancer patient.

Invest Northern Ireland and The McClay Foundation, the charitable trust established by the late Sir Allen McClay, are partnering to fund the lab facilities and staff costs. Invest NI has offered the Almac Group and QUB £1.5 million of support towards the collaboration, which includes part funding from the European Regional Development Fund (ERDF).

The collaboration was announced ahead of CCRCB’s 3rd International Cancer Symposium tomorrow (Wednesday and Thursday 7-8 September), which attracts leading cancer experts from around the world to focus on how academia can interact with industry to improve cancer treatment.

Professor Kennedy, the newly appointed McClay Chair of Experimental Cancer Medicine at Queen’s University – a joint appointment with Almac – said the project was an excellent example of how business and academia could work together in the fight against cancer, the leading cause of death in Western civilizations.

He explained: “The research will involve using cutting-edge technology developed by Almac which will allow us to analyse large numbers of patient tumours collected by Queen’s.

“We will develop these tests to help clinicians to better understand prostate, ovarian and breast cancer and prescribe the appropriate treatments tailored to the specific patient.

“We hope this will then improve the chances of cure using chemotherapy and radiotherapy.

“Queen’s and Almac will also use this information to design new therapies that could improve the chances of response and cure for these cancers in the future.

“More effective treatments will be good news for patients and also for reducing the pressure on the overburdened healthcare system.”

Enterprise Minister Arlene Foster said: “Almac remains at the cutting edge of drug development and delivery for specific types of cancer and with Invest NI support, has invested heavily in research projects which have delivered significant economic benefits and advancements in cancer treatment worldwide.

“The company is globally respected for its commitment to innovation and this collaboration project will build upon a successful and longstanding research relationship between Almac and Queen’s University, Belfast. Such academic and industrial linkages are vital to the growth of our economy as they strengthen our knowledge base and enhance Northern Ireland’s reputation as an international research and development hub.”

At this week’s symposium Professor Kennedy will present new research on better tailoring chemotherapy for breast cancer. He will also introduce the speaker of the 2011 McClay Foundation Lecture, Richard M Goldberg from the University of North Carolina and North Carolina Cancer Hospital.

Notes to Editors

The Almac Group provides a broad range of pharmaceutical services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The McClay Foundation, established by Almac founder, the late Sir Allen McClay in 2008, is a charitable trust which aims to advance the use of diagnostic tools and drugs in the prevention, control and cure of the disease; support and encourage research and innovation in the field of healthcare and allied technologies increase capacity of all people and specifically those in the developing world to access the latest benefits in healthcare and to generate and promote employment opportunities for the people of Northern Ireland.

Invest NI has offered the Almac Group and QUB £1.5 million of support which includes part funding from the European Regional Development Fund under the Sustainable Competitiveness Programme for Northern Ireland.

For more information about Almac contact Jane Wells or Andrea Clements at JPR on 028 9076 0066. Jane.wells@jprni.com, 07860 288 860

Andrea.clements@jprni.com, 07808 761 857

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Almac wins ‘The American Society for Quality’ Award in Philadelphia

admin — Tue, 19 Jul 2011 10:32:12 +0000

Almac’s Clinical Services business unit was presented with the ‘ASQ Philadelphia Section Large Company Member of the Year’ award at the section’s awards dinner held at the Timber Room at Wegman’s in Malvern, PA on 22 June. The award is presented annually to the company with more than 200 employees with the leading participation in section activities.

Receiving the award on behalf of Almac was Mark Rohlfing, Director of Quality for Clinical Services in Pennsylvania. “The award is a credit to the work of two groups of people including the Philadelphia Section of ASQ, which provides wonderful opportunities for folks from various industries to learn from one another, and the staff at Almac who take time away from their busy work and personal schedules to continue to learn and grow professionally for the good of themselves and Almac.”

In addition to Almac’s local involvement, over the years dedicated Almac employees have also obtained formal certification from ASQ in a number of quality fields from auditing to quality management. “ASQ certification shows that our employees are dedicated in understanding modern approaches to maintaining and improving quality within our business and because of that Almac has always been a big supporter” says Rohlfing.

The American Society for Quality is the world’s leading authority on quality and advances the professional development, credentials, knowledge and information services, membership community, and advocacy on behalf of its more than 85,000 members worldwide. The Philadelphia Section is one of the largest and most active of ASQ’s 250 sections.

The Almac Group also recently celebrated the official opening of its New North American Head Quarters in Philadelphia this spring- the $120m project houses state-of-the-art facilities and provides huge capacity, specifically for global clinical trial supply production and distribution.

For more information on Almac’s services visit almacgroup.com.

Notes to Editors About Almac Group

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac wins ‘The American Society for Quality’ Award in Philadelphia appeared first on Almac.

Almac to perform the analytic phase of AclarusDx™ for Exonhit

admin — Mon, 04 Jul 2011 08:53:30 +0000

Almac’s Diagnostic Services business unit today announced that it will be the central service lab to perform the analytic phase and deliver to the clinicians the result of Exonhit AclarusDx™ diagnostic test.

Exonhit AclarusDx™ is a micro-array-based test intended to aid in the diagnosis of Alzheimer’s disease (AD) by detecting biomarkers specific for AD in peripheral blood. The test was CE marked in March 2011 and has now been introduced for clinical diagnostic use in France. The test will be performed by Almac from its ISO17025 accredited laboratory. Almac will deliver the AclarusDx™ result to the clinicians.

Almac recently announced the opening of its CLIA registered Clinical Testing laboratory from which it is currently delivering the Therascreen® K-RAS Mutation Test. AclarusDx™ will be the second commercial clinical test that will be managed by Almac. In addition to standard molecular tests Almac will deliver a range of novel, validated biomarker assays from its Clinical Testing Laboratory to facilitate the stratification and enrichment of prospective clinical trials.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Services business said:

“The partnership with Exonhit is an excellent arrangement for both companies. Exonhit will focus on the sales and marketing of AclarusDx while we will focus on the delivery of the diagnostic in our ISO17025 certified laboratory.”

Loïc Maurel, M.D., Chairman of the Management Board at Exonhit said:

“We chose Almac Diagnostic Services as our reference lab to perform the analytic phase of AclarusDx™ due to its strong expertise in molecular biology and its practice of the Affymetrix platform. We also view the location of Almac Diagnostic Services in Northern Ireland as an asset for the upcoming roll-out of AclarusDx™ in Europe.”

Ends….

Notes to Editors

About Almac

The Almac Group offers a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Staff have now transferred to Almac’s new $120m North American Headquarters which is now fully operational.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

About Exonhit

Exonhit (Alternext: ALEHT) is a biotech company, focused on personalized medicine, which develops targeted innovative therapeutic and diagnostic products, in oncology and Alzheimer’s disease. Exonhit has a balanced investment strategy with internal development programs and strategic collaborations, in particular with Allergan.

Exonhit is headquartered in Paris, France and has a U.S. subsidiary in Gaithersburg, Maryland. The Company is listed on Alternext of NYSE Euronext Paris and is part of the NYSE Alternext OSEO innovation index. For more information, please visit http://www.exonhit.com.

Disclaimer

This press release contains elements that are not historical facts including, without limitation, certain statements on future expectations and other forward-looking statements. Such statements are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those anticipated.

In addition, Exonhit, its shareholders, and its affiliates, directors, officers, advisors and employees have not verified the accuracy of, and make no representations or warranties in relation to, statistical data or predictions contained in this press release that were taken or derived from third party sources or industry publications, and such statistical data and predictions are used in this press release for information purposes only.

Finally, this press release may be drafted in the French and English languages. In an event of differences between the texts, the French language version shall prevail.

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Almac Expands Global Coverage by Adding Depots for Clinical Trial Supply Distribution to the Asia Pacific Region

admin — Thu, 30 Jun 2011 09:06:46 +0000

Almac’s Clinical Services business unit, a leading provider of contract services to the clinical trial supply industry serving Pharmaceutical and Biotech companies worldwide have increased its presence in the Asia Pacific region. It has extended its reach by adding five new depots located in – Japan, Thailand, Hong Kong, Taiwan to its extensive global depot network. These latest developments in the Asian market enable Almac to provide customers with even more flexibility in their supply chain solution for their specific country clinical trial requirements. The number of depots within the Network is now 36 with a further 5 planned for 2012.

As part of Almac’s continued expansion of services globally they have also sought to expand their controlled drug network in Europe to ensure they have a network capable of storing this class of drugs within each EU country.

Almac’s Global Depot Network is managed by dedicated depot management teams who serve as the central contact point for the network and also perform regular visits to the depots which are fully audited and GMP compliant. In line with continuous depot expansion the resources within the Depot Management Team have also increased over the past 6 months. There are now 15 members of staff who are located in the UK, USA and Brazil that are dedicated to managing protocols across the depot network.

Mark Woolf, Global Depot Manager for Almac’s Clinical Services business unit commented ‘The latest depots are a very welcome addition to our network and have been strategically positioned in locations worldwide to ensure we can supply emerging markets with a consistent high level of service.’

Almac has over 20 years experience in the management of clinical trial supplies serving the majority of the top pharma and Biotech companies. Alongside distribution services Almac also provides specialist packaging/ labelling services, QP & Clinical Supply Management consulting services.

Notes to Editors About Almac Group

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Almac to Feature New Enhancements to its Integrated Supply Chain Management and Patient Compliance Services at the Annual DIA Meeting in Chicago

admin — Fri, 17 Jun 2011 08:14:54 +0000

Almac, a leading provider of clinical supply and IXRS^®(IVRS/IWRS) technology solutions, announced today that it will showcase new enhancements to its suite of Integrated Supply Chain Management and Patient Compliance Services at the 47^th Annual DIA Meeting in Chicago, IL. The new services (Shipping Temperature Electronic Monitoring System (STEMS), SMS/Text patient reminders, and consultation on packaging and labeling designs to improve patient compliance) are designed to support Almac’s objective of Making Clinical Trials Work Better^TM for patients, sites, and sponsors.

STEMS is a web-enabled, fully-validated data management system that assures pharmaceutical products are monitored within acceptable temperature ranges during shipping. STEMS provides immediate visibility on upload of shipment temperature reports and allows users to make instant decisions on temperature data essential to management of drug supplies. Providing online data access to sponsors is important to reduce quarantine times in trials where the period from shipment-receipt to dispensation to the patient is limited. This is a key enhancement to Almac’s integrated drug supply management solution that includes Manufacturing & Blinding, Patient Screening and Enrollment, Biostatistical Services, Randomization & Drug Assignment, Packaging and Labeling, Global Distribution & Depot Network, QP Release & Analytical Support, Cold Chain Storage and Shipping Temperature Electronic Monitoring System (STEMS), Drug Inventory Management, Patient Compliance programs, Study Closeout/Drug Reconciliation, IXRS^®Technology (IVR/IWR), and Data Integration & Reporting.

Robert Dunlop, President of Almac’s Clinical Services business unit comments on the significance of this new service offering. “STEMS satisfies an important need of our clients: making certain that drugs used in clinical trials are closely monitored for temperature excursions. By facilitating data upload and removing the need to return temperature control monitors, STEMS significantly streamlines the clinical supplies logistics process. And as part of Almac’s ongoing strategy to improve clinical supply chain management, we are pleased to announce that STEMS is compatible with Sensitech TempTale 4^® devices, allowing integration with one of the leading, industry standard monitors.”

Almac will also feature new enhancements to its Patient Compliance service offering at the DIA Conference. As part of its effort to improve patient compliance from initial recruitment to study closeout, Almac will showcase new components of its service offerings: Consulting on Packaging and Label Design for trial supplies and patient reminder services. The latter involves sending patients electronic reminders for a variety of tasks during a clinical trial, such as attending site visits, taking medication, fasting before laboratory visits, and completing Electronic Patient Reported Outcomes (ePRO) diaries, among others.

Almac’s President of Clinical Technologies, Jim Murphy, comments on the enhancements to Almac’s integrated services on patient compliance. “Almac is unique in the industry because we offer services that focus on driving patient compliance throughout the patient’s journey in a clinical trial. Our multi-modal patient reminder services (SMS/text, email and outbound calls) as well as Almac’s expertise in consulting and delivering supplies packaging and labeling services, provide sponsors with a variety of options to improve compliance rates and assure patients adhere to study protocols. Compliance is crucial to assuring patient safety and data quality during the trial, and Almac is focused on helping our clients achieve those key objectives.”

To reinforce its focus on patient management and integrated services, Almac’s industry experts Graham Nicholls, Director of Biostatistics, Hannah O’Gorman, Product Manager of ePRO, and Jennifer Ross, Senior Biostatistician will speak at the DIA conference on topics relating to ePRO, as well as patient retention and compliance in clinical trials.

Please visit booth # 1711 to view demos of STEMS and Almac’s new Patient Compliance Solutions.

-End-

Contact:

Kristi Bronico

T: (1) 215-660-8500

E: clinicaltechnologies@almacgroup.com

W: almacgroup.com

About Almac Group

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac to Feature New Enhancements to its Integrated Supply Chain Management and Patient Compliance Services at the Annual DIA Meeting in Chicago appeared first on Almac.

Almac data to be presented at annual ASCO meeting

admin — Tue, 31 May 2011 11:36:00 +0000

Almac’s Diagnostic Services business unit today announced research to be presented at ASCO.

Two of Almac’s main research projects have been selected for presentation at the 2011 ASCO meeting. Both of these studies are based on Almac’s approach of profiling large clinical datasets and analysing the data for molecular subgroups that can aid in improved diagnosis of cancer by identifying molecular subtypes and by identifying molecular subgroups which are of clinical and therapeutic relevance.

The first study was carried out in ovarian cancer and will be the subject of a podium presentation by Dr Charlie Gourley of the University of Edinburgh Cancer Research UK Center, where the patients were treated. The aim of the study was to identify molecular subtypes of ovarian cancer through profiling of a large clinical dataset of 363 patient samples. Unsupervised analysis of the full dataset identified 6 molecular subgroups which were highly associated with histology. Subsequent further analysis of the serous cancers identified 3 subgroups with the dominant biology of one of these related to angiogenesis. This subgroup may be useful in identifying patients more ideally suited to treatment with anti-angiogenic therapeutics. This research will be presented at the Clinical Science Symposium entitled ‘Ovarian Cancer: Novel Approaches to Improve Treatment Outcomes’ on 4^th June at 1.15pm in McCormick Place Room E354a.

The second study to be presented was carried out in breast cancer. In this study, a molecular subgroup was discovered which is DNA damage response deficient. This has resulted in the generation of a signature which is capable of identifying patients who do not respond to standard DNA damaging chemotherapy with a very high negative predictive value and relative risk. It is proposed that this signature will be developed into a patient stratification tool for existing chemotherapy or a trial enrichment tool for DNA damaging or repair targeted drugs in development. This research will be presented at a poster discussion session on 4^th of June at 5pm in McCormick Place Room S100bc.

Both studies were carried out using Almac’s proprietary Cancer DSA™ discovery arrays. These tools have been optimized to obtain data from FFPE samples.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Services business unit said:

“The ASCO meeting is always an important event in our calendar. We are very happy to have the opportunity to showcase some of our research at the meeting this year. Both of the studies being presented have significant clinical relevance and are likely to be of significant interest to both clinicians and the Pharma companies represented.”

Dr. Charlie Gourley of the University of Edinburgh Cancer Research UK Center, who will present the Ovarian cancer data said:

“As clinicians, we know from our day to day practice that ovarian cancer is a heterogeneous disease. This study shows that when patients are categorised according to the gene expression of their primary tumour that the 6 main subgroups which result have significantly different outcomes. Intriguingly, the gene expression profiles of some of the subgroups suggest that they may be particularly amenable to treatment with novel targeted agents such as anti-angiogenics. We are hopeful that this molecular classification will act as the template for the individualisation of ovarian cancer care based upon the biology of the patient’s tumour. ”

Ends….

Notes to Editors

About Almac

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac data to be presented at annual ASCO meeting appeared first on Almac.

Almac celebrate official opening of North American HQ with former US. Senator George Mitchell

admin — Fri, 20 May 2011 14:40:47 +0000

One of Northern Ireland’s most successful companies the Almac Group, is celebrating the official opening of its new North American Headquarters.

With global headquarters in Craigavon, Almac employs more than 3,000 people and provides services to more than 600 pharmaceutical and biotechnology companies worldwide.

The official opening was performed by former U.S. Senator George J. Mitchell, who most recently served as Special Envoy to the Middle East and was Chairman of the all party negotiations which led to the Good Friday Agreement of 1998.

Welcoming Senator Mitchell to the ceremony were Almac Chief Executive Alan Armstrong and Lady Heather McClay, wife of Almac’s founder, the late Sir Allen McClay. Almac CEO Alan Armstrong said “We are delighted to officially open our new North American Headquarters. The $120m investment is one of the largest ever made by a Northern Ireland owned firm in the United States and represents the continued expansion of the business on both sides of the Atlantic.

“With our rate of growth it is essential we build capacity in both our Northern Ireland & US operations to ensure the business continues to compete at a global level. It is a testament to the ambition of our founding Chairman Sir Allen McClay, who originally envisaged this project, and we are proud to have brought it to fruition.”

A centerpiece of the opening was the dedication of a major art installation of fused glass that tells the story of Almac and its growth over the years. The glass designs are interwoven with scientific references, symbols associated with Northern Ireland as well as those contained within the Pennsylvania State Crest. The work was designed and produced entirely in Northern Ireland, by David Esler in Leadlines, based in Co Antrim, before being carefully shipped across the Atlantic.

Lady Heather McClay said, “The installation is a wonderful tribute to Allen’s achievements and of those he called the ‘Almac family’. We are honoured to be joined by Senator Mitchell as someone who has played a key role in moving Northern Ireland into a new era. He is deservedly recognised in Northern Ireland for his role as Special Envoy and Chairman of the All-Party talks but his work as Chancellor of Queen’s University Belfast makes his presence here today particularly fitting as that institution was very close to Allen’s heart.”

Speaking at the opening Sen. George Mitchell paid tribute to the vision of Sir Allen McClay.

“Sir Allen had a real vision for this company and the building we are dedicating today will be a fitting monument to his life and work. This facility will be important not only to the economy of Pennsylvania but to the health of people all over the world.”

Almac’s $120 million, 240,000 square foot new North American headquarters houses more than 800 employees in state-of-the-art facilities. With low greenhouse gas emissions and a water reclamation program, the facility strives to maintain sustainability and has already added 300 new jobs to the greater Philadelphia region.

The event was also attended by dignitaries and representatives from State & local government level in Pennsylvania, a wide range of global pharmaceutical companies, as well as local families from the area and those who cared for Sir Allen in his period of illness in Hahnemann Hospital.

-Ends-

Contact:

John Hart

Stakeholder Communications

02890 339949 / 0779 147 0512

About Almac

The Almac Group offers a broad range of services, from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs more than 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information on Almac, please visit almacgroup.com.

To find out more about Almac visit almacgroup.com

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Almac to host inaugural European Product Launch workshop for US Biopharmaceutical Companies

admin — Wed, 11 May 2011 08:54:58 +0000

Almac to host inaugural European Product Launch workshop for US Biopharmaceutical Companies

Almac is hosting its inaugural European Product Launch workshop in Boston, MA on 17^th May 2011. Targeted specifically at the biopharmaceutical sector, the workshop provides consultative advice and services to US companies to successfully launch drug products onto the European market.

The workshop will provide US companies with important market and regulatory framework knowledge, whilst guiding them through the European product launch process right through from submitting an MAA to final distribution of drug products to end-users.

Attendees will also learn from the real life experiences of 3 of Almac’s many US clients who have successfully launched drug products into the European marketplace including: Eisai Inc, Millennium: The Takeda Oncology Company and The Medicines Company.

Ian Markwell, VP of Quality for Almac’s Pharma Services business unit commented ‘This workshop provides a significant opportunity for US companies to learn first hand of the processes of launching product into Europe, as many companies based outside the EU, find the European regulatory and quality framework complex.’

One of the key presenters at the workshop Ms Trudy Burke, Senior Director, Baltimore & Gliadel Operations, Eisai Inc remarked: ‘I am delighted to share my experience of partnering with Almac, while helping to advise US companies on the challenges of launching a high value, temperature sensitive product in Europe.’

Further details of this workshop can be found at http://almaceuproductlaunch.eventbrite.com or by contacting Tania Davis (Tania.davis@almacgroup.com) directly.

ENDS

Contact:

Tania Davis

Almac Pharma Services

T: +44 (0)28 3836 3363

E : tania.davis@almacgroup.com

Tristan Jervis

DeFacto

T.Jervis@Defacto.com

Tel: + 44 2078 613019

About Almac Group

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, pharmaceutical development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture and packaging. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac to host inaugural European Product Launch workshop for US Biopharmaceutical Companies appeared first on Almac.

Todd Kole Appointed to Almac’s Clinical Technologies Executive Team

admin — Fri, 06 May 2011 08:17:20 +0000

Almac’s Clinical Technologies business unit announced today that Todd Kole has joined the company as Vice President of Clinical Project Services (CPS) and a member of the Executive Leadership Team. As Vice President of CPS, Todd will report directly to the President of Almac Clinical Technologies and will oversee clinical project management and drug supply services globally.

Mr. Kole has extensive experience in the biopharmaceuticals industry, with specialized expertise in clinical technologies and clinical supplies management. He has served in a variety of capacities involving the provision of Interactive Voice and Web Response Systems (IVR/IWR) technologies, clinical and technology personnel management, as well as global project and client account management.

Mr. Kole joins Almac after spending 12 years at Clinphone and Perceptive Informatics. At Clinphone, Mr. Kole served as Director of US Operations before being promoted to Vice President of Global Client Services. In operations roles at Clinphone he was responsible for approximately 175 staff, ensuring operational accountability in managing the quality and timeliness of IVRS design, build, delivery and support. As VP of Client Services at Clinphone, he held global oversight responsibilities for the Project Management and Client Account Management divisions. During his tenure as Vice President of IVR Operations at Perceptive Informatics, Mr. Kole held P&L responsibilities and was a member of the Perceptive Executive Management Team. In that role, he was integral in working with clients and operations personnel during the acquisition of Clinphone by Perceptive Informatics.

Jim Murphy, President of Almac’s Clinical Technologies business unit comments on Mr. Kole’s appointment: “We are very pleased that Todd Kole has joined Almac. He brings a tremendous amount of industry experience to our firm that will help Almac maintain high levels of operational excellence as we continue to grow. Further, given the depth of his drug supply expertise, Todd will be instrumental to the continuing advancement of Almac’s market leading total drug supply chain management service. We welcome Todd to Almac and know he will have a profound impact on the development of the team and our client relationships.”

END

Contact:

Kristi Bronico

T: (1) 215-660-8500

E: clinicaltechnologies@almacgroup.com

W: almacgroup.com

About Almac Group

Almac’s Clinical Technologies business unit specializes in interactive technology and service solutions to increase the quality and efficiency of clinical trials. Our solutions include Interactive Voice and Web Response Systems (IXRS®) for patient randomization and drug assignment, patient and clinical supplies management, electronic-patient-reported-outcomes data collection, and Web drug reconciliation. Almac’s technologies have been deployed in over 1600 clinical trials, incorporating over 1.5 million patients in over 80 countries, and more than 60 languages.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Almac Introduces selectAZymeTM

admin — Wed, 04 May 2011 08:56:32 +0000

Almac’s biocatalysis business continues its strong growth and boosts its visability with the launch of the selectAZyme^TM brand.

As anticipated, Almac’s biocatalysis business has expanded from its 2009 launch with the sale of six enzyme screening kits, to the current supply of 100s of kgs of chiral intermediates for drug substance manufacture, regular enzyme supply to specialty chemical companies and continued growth of its screening kits offering. Biocatalysis is increasingly recognised as an alternative solution for solving complex chemistry problems due to its rapid implementation, economic benefits and ‘green‘, reputation. Almac’s growth in this area was further enhanced last year through a $4 million R&D investment. The natural next step for the business is the launch of the selectAZyme^TM brand to enhance its recognition.

“The selectAZyme^TM brand conveys Almac’s strong biocatalysis offering. Almac is providing a diverse, A-Z range of enzymes including reductases, transaminases, hydrolases, nitrilases and many others. In collaboration with our customers, Almac selects the optimum enzyme to provide an efficient and cost effective process. Almac enzymes are used in the A-Z of applications from medicinal chemistry to full production and in the manufacture of specialty chemicals. The key strength of enzymes is the high selectivity of the chemical reactions they catalyze”, comments Dr. Tom Moody, Head of Biocatalysis.

The rapid scale-up from biocatalyst screening to production prompted the recent paradigm shift to bioprocessing acceptance for the synthesis of APIs and fine chemicals. Biocatalysis is Almac’s first choice for any scale-up of chiral chemistry due to the cost, efficiency, robustness and ‘green’ benefits that result.

Metabolite synthesis is another tool within selectAZyme’s service offering providing access to both oxidative and glycosylated products. Almac has implemented state-of-the-art biocatalytic technology for rapid metabolite synthesis, isolation and structural identification. Almac has developed recombinant P450 technology for accessing metabolites at mg to 100s grams. These enzymes, which mimic human P450 systems, are a powerful tool for accessing metabolites rapidly. Moody further elaborates, “The marriage of microbial and recombinant enzymes is a real powerhouse in accessing difficult to synthesise metabolites. The scale-up capability allows Almac to rapidly take “hits” from conception to gram delivery as and when the customer requires the products.” In addition, Almac can also supply radiolabelled versions of these metabolites utilizing their in-house Isotope Chemistry group.

Almac also offers technology consultancy, aiding and supporting clients to set-up and run enzyme screening and scale-up in their own labs. Almac does not impose any IP roadblocks to implementing the technology and provides a simple and direct path for customers to access the benefits of biocatalysis. Recently Dr. David Rozzell, a world renowned authority in biocatalysis, has signed-on as Scientific Advisor to help Almac advance the technology.

The selectAZyme^TM service complements Almac’s speciality capabilities, including radiolabelling, polymorph and solid form optimisation, and peptide and protein synthesis. These services are all part of Almac’s comprehensive Drug Discovery Services, including API and Drug Product Development and GMP Manufacture.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors:

About Almac Group

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac Introduces selectAZymeTM appeared first on Almac.

Almac wins 2011 Northern Ireland Business of the year accolade

admin — Wed, 13 Apr 2011 13:40:36 +0000

Award recognises Almac’s continued growth success and presence as a world class player in pharmaceutical and biotech services

The Almac Group, headquartered in Craigavon Northern Ireland, is celebrating another highly impressive year after being named ‘Business of the Year’ (for the second time in 3 years), together with other significant accolades at the Northern Ireland business awards – run by the nation’s main daily newspaper, The Belfast Telegraph in association with BMI (British Midland International).

Almac was recognised for its continued excellence in the field of contract drug development and manufacturing within the biotechnology and pharmaceutcal sectors, in which the company is globally renowned as a world class services provider. This year, Almac has again gone from strength-to-strength growing significantly despite the challenging economic environment. . The Company is now successfully delivering critical patient medication to over 100 countries, with 89% its £250million global sales coming from outside the UK – representing a 10% increase in annual revenues compared with the previous year.

Almac picked up the overall ‘Business of the Year’ accolade, in addition its Clinical Services’ business unit winning ‘outstanding business team of the year’ for its business development and marketing activities. The team was recognised for its role in positioning Almac as a single, truly integrated services company by establishing cross selling opportunities, joint bids and integrated management approaches across the entire group. Additionally, the company was commended for providing innovative solutions that respond to growing customer need for pharmaceutical products to be maintained under refrigerated temperatures during distribution and for the successful export and manufacture of clinical supplies, clinical supply management , packaging and labelling of patient kits and warehousing, logistics and depot management.

Almac Group CEO Alan Armstrong expressed his pride in the recognition and said that he expected 2011 to be an exciting year for the company.

“Winning the 2011 “outstanding business team of the year’ was a great accomplishment for Almac at Northern Ireland’s main business awards, but to be recognised as the Country’s pre-eminent business for the second time in 3 years shows our success in achieving sustained economic growth in a competitive and challenging global economic environment.“

“Our strong expansion is testament to our focus on innovation, quality and dedication of the entire team across the Almac Group. Indeed, I’d like to take this opportunity to thank all our staff for their contribution to this fantastic achievement – they are the heart of our business.”

Judge Ian Murphy from Invest NI said the panel’s decision to recognise Almac was made “for transforming a Northern Ireland company to a company of global stature in the pharmaceutical and biotech sectors”

About Almac Group

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Northgate Managed Services Delivers Seamless Transfer to Almac’s New US HQ

admin — Thu, 07 Apr 2011 08:58:56 +0000

More than 15,000 records updated securely each day during a major migration programme thanks to Northgate’s expertise.

Newtownabbey based IT specialist, Northgate Managed Services has cemented its eight year partnership with global pharmaceutical company, The Almac Group after successfully migrating its global online resources to Almac’s new US headquarters in Souderton, Pennsylvania.

The new headquarters houses clinical trial supply and technology services as well as introducing Almac’s analytical services to the U.S. for the first time.

Using a specialist web application, up to 15,000 records are securely created and updated each day from Almac’s clients, worldwide. Northgate’s role was to manage the transition of key web services from its old data center locations to its new operation, whilst ensuring that clients experienced no downtime during the migration process.

A specialist team from Northgate was responsible for the highly time sensitive project which demanded meticulous planning together with implementation of the latest Citrix NetScaler web security technology. Now fully integrated, the new solution also allows Almac to meet the growing demands for its services from pharmaceutical and biotech companies world-wide.

Commenting on the success of the project Andrew Hillis, Group Head of Information Services for the Almac Group said, “The decision to move key operations to our new Souderton site was based on business growth and development, but the transition process had to be flawless, with absolutely no break in service. Having worked with Northgate for eight years, the company’s experience, expertise and understanding of our business proved vital. The end result was the successful transfer and centralisation of resources, with an enhanced and highly effective infrastructure which is positioned to allow for future growth.”

James Turnbull, Managing Director, Infrastructure Solutions, Northgate Managed Services said, “Almac’s feedback on the project is a strong endorsement of Northgate’s expertise and project management skills. Our client understanding and business insight proved key and ensured Almac delivered its three core commitments of innovation, quality and customer service. We look forward to developing and strengthening our partnership in the future.”

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Almac open CLIA lab for biomarker clinical trials

admin — Wed, 30 Mar 2011 09:00:45 +0000

Almac’s Diagnostic Services business unit today announced the opening of its CLIA registered laboratory.

The opening of the Almac CLIA Laboratory supports the company’s ongoing Biomarker Discovery and Development Strategy by enabling the use of novel tests to stratify and enrich prospective clinical trials. This ability is of key importance as Almac begins to transition the novel biomarkers that they have developed into clinical use, with the resulting potential to inform the drug development process and target therapies to responsive patients.

In addition to standard molecular tests, Almac have a pipeline of both internal clinical tests and companion diagnostic tests with Pharma partners in development that will be delivered from the Almac CLIA Laboratory.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Services business said:

“We are very happy to announce the launch of our CLIA lab, which has been opened to meet both our needs and the needs for our Pharma partners. We have come to a point where the biomarkers we have discovered and assays that we have developed are being used to stratify patients, enrich clinical trials and impact patient treatment decisions. As such, CLIA is a key necessity for the processing of these samples.”

Almac’s genomics laboratories have been supporting biomarker discovery projects for 8 years and already operate under ISO17025 accreditation and work to the principles of GLP.

About Almac

The company employs almost 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Staff have now transferred to Almac’s new $120m North American Headquarters which is now fully operational.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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BioFocus and Almac collaborate to offer fluorescent lifetime assays

admin — Mon, 28 Mar 2011 11:49:44 +0000

BioFocus and Almac have initiated a collaboration which will provide BioFocus customers with compound screening and profiling services using Almac’s FLEXYTETM fluorescence lifetime (FLT) assays. FLT as a reading modality offers a robust, antibody free, homogeneous assay platform which enables the user to avoid interference from fluorescent compounds within a screening library.

BioFocus has launched an FLT screening and profiling service utilising the FLEXYTETM assay platform and now offer campaigns against targets including proteases, phosphatases and kinases. The unique properties of FLT have also been harnessed to open up access to previously inaccessible epigenetics target classes. Several approaches can be taken using the FLEXYTETM platform including fragment based screens and kinetic profiling.

‘Being able to incorporate FLT in our service offering enables BioFocus to provide clients an approach to screening and profiling that will unlock significant potential within their drug discovery efforts’ commented Dr Kate Hilyard, VP Biological Sciences, BioFocus.

‘We are delighted that BioFocus has chosen to add our FLEXYTETM platform to their service offering. We feel that this will allow a broad range of drug discovery groups access to the power of FLT’ said Dr Stephen Barr, President and Managing Director of Almac Sciences.

For media enquiries please contact:

Tristan Jervis , Associate Director

DeFacto Communications

T.Jervis@Defacto.com

Tel: + 44 2078 613019

Robert Grundy, PhD

Director Research Alliance, Almac Discovery Ltd

Robert.grundy@almacgroup.com

T: +44 (0) 28 3833 2200

About BioFocus

BioFocus aims to expand its partners’ drug pipelines by accelerating the gene-to-drug candidate discovery process. This is achieved through a comprehensive discovery platform, which includes target discovery in human primary cells, focused as well as diverse compound libraries, in vitro and cell-based screening, structural biology, medicinal chemistry, ADME/PK services, supported by unique chemogenomic and informatics tools, and compound library acquisition, storage and distribution services. As a service division of Galapagos, BioFocus has over 250 employees in four countries worldwide. More information at www.biofocus.com

About Almac Group

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new $120m North American Headquarters located in Souderton PA.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

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Almac announces expansion to its commercial facility with the addition of increased storage capacity for biologic products

admin — Fri, 25 Mar 2011 11:41:12 +0000

In response to increased client demand for cold and dedicated frozen storage capacity for biopharmaceuticals, Almac’s Pharma Services business unit has expanded its commercial facilities to include an additional 6124 sq ft of cold and frozen storage.

This is a joint investment with a commercial client, for which Almac provides central EU importation, warehousing and distribution services. This includes dedicated -70°C, -20°C and 2-8°C storage for drug antibody, drug linker, bulk drug substance, placebo and filled vials, coupled to before and after distribution to various global processing facilities.

In preparation for the successful commercialisation of the drug product, 20 additional dedicated freezer units have been added to the existing 10, for the storage of the monoclonal antibody and bulk drug substance products.

Strengthening Almac’s EU product launch services, the expansion has also resulted in increased floor space facilitating shipping system configuration for bulk drug product and for direct to pharmacy supply of niche orphan drug products.

David Downey, Vice President, Commercial Operations comments “It is a pleasure to be able to expand our scope of services through this shared investment. Our ability to ensure all necessary preparations are made for this important commercial launch, positions Almac well within this growing biopharmaceutical sector”.

About Almac

The Almac Group offers a broad range of services from R&D, biomarker discovery and development, API manufacture, pharmaceutical development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture and packaging. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs almost 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Staff has now transferred to Almac’s new $120m North American Headquarters which is now fully operational.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac announces expansion to its commercial facility with the addition of increased storage capacity for biologic products appeared first on Almac.

Almac to Demonstrate New Patient Management Services at the Euro DIA and Partnerships in Clinical Trials Conferences

admin — Wed, 23 Mar 2011 11:35:32 +0000

Almac announced today that its Clinical Technologies business unit, a global leader in clinical trial management, will launch a suite of new services designed to improve patient compliance and retention in clinical trials. The new services will be demonstrated at the DIA’s 23rd Annual EuroMeeting located in Geneva, Switzerland, 28-30 March and at the Partnerships in Clinical Trials Conference in Phoenix Arizona, 30 March – 1 April. Almac is a leading provider of IXRS® (Interactive Voice and Web Response) services for patient and drug supply management. Recently, Almac has enhanced its offerings by forming an exclusive integrated trial management alliance with Exco InTouch, an innovative firm specializing in patient recruitment, retention, compliance, and ePRO services.

The joint Almac-Exco InTouch service offering enhances patient retention and compliance through the use of multiple technologies, such as SMS text messages and emails. The technology reminds patients to complete key elements of their required study obligations, such as taking medication, attending appointments, fasting prior to laboratory testing, filling out diaries, and others, while also collecting reasons for non-compliance. Almac is ideally suited to deliver this new suite of services by combining its industry leading IXRS® technology (used to screen, enroll, and randomize patients into clinical trials) with the Exco InTouch patient reminder capabilities. Working with sponsors on clinical trials, Almac will develop study-specific patient retention and compliance programs that will begin immediately upon randomization into the trial and remain in effect until the trial is completed.

Almac Vice President of Business Development, Geri Beyer comments on the launch: “We are very excited to offer the first-ever demo of this unique integrated service line which will revolutionize the future of patient and trial management for sponsors. With the increasing number and complexity of trials that Almac is managing across the globe, we are pleased to offer innovative and cost-effective technologies to our clients that will drive compliance and enhance productivity throughout the clinical trial.”

In addition to featuring the new integration with Exco InTouch, Almac will be demonstrating its world-class IXRS® (Interactive Voice and Web Response) services and Almac’s Interactive Reporting solution, two services that were launched in 2010.

Visit Almac at the 23rd Annual DIA EuroMeeting (booth # 1501) and Partnerships in Clinical Trials (booth #612) and participate in a special poster presentation by Hannah O’Gorman on “Identifying Patients’ Reasons for Non-Compliance in ePRO Studies to Improve Data Collection Methods.”

Contact:

Kristi Bronico

T: (1) 215-660-8500

E: clinicaltechnologies@almacgroup.com

W: almacgroup.com

About Almac Group

Almac’s Clinical Technologies business unit specializes in interactive technology and service solutions to increase the quality and efficiency of clinical trials. Our solutions include Interactive Voice and Web Response Systems (IXRS®) for patient randomization and drug assignment, patient and clinical supplies management, electronic-patient-reported-outcomes data collection, and Web drug reconciliation. Almac’s technologies have been deployed in over 1600 clinical trials, incorporating over 1.5 million patients in over 80 countries, and more than 60 languages.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac to Demonstrate New Patient Management Services at the Euro DIA and Partnerships in Clinical Trials Conferences appeared first on Almac.

The A to ZED of Automated Walleting for clinical trial supply

admin — Wed, 16 Mar 2011 10:31:34 +0000

Global Clinical Services provider Almac has announced an investment in two ZED automated inline wallet presses. Operating in Craigavon and Pennsylvania, the fully automated machines will drastically reduce timelines associated with the use of blister card packaging, when compared with current rotary press methods.

The automation on the machine allows for accurate placement of blister strips into the wallet cards. The location and orientation of the blisters is then verified by a vision system prior to sealing the card. This helps to keep rejects to a minimum and maximises yield on product. This is the latest development in an ongoing campaign by Almac to continually invest in automation as a boost in efficiency and capacity to core primary packaging services.

Commenting on the new machines, Almac’s Global VP of Business Development Martin Lamb said “The machines are a welcomed addition to Almac’s growing portfolio of automated primary packaging services as they demonstrate the company’s continued commitment to innovation and driving improvements across the clinical supply chain. These lines are ideal for larger Phase III trials that can require higher volumes of wallet cards. Also product pooling and using supplies across multiple protocols can drive card quantities past the traditional smaller volumes required for clinical supply. This allows us to provide the client with the right option for their study. ”

The investment comes at a time when Almac is gearing up for the official opening of their New North American Headquarters facility. The $120 million project, which began in Summer 2008 is now operational with the official opening of the 240,000 square foot premises planned for May 2011.

With over 20 years experience in clinical supply management Almac is recognised as a strategic partner in the clinical supply process by pharma and biotech companies across the world. These recent investments are a sign of their dedication to offer market driven solutions to their customers.

The post The A to ZED of Automated Walleting for clinical trial supply appeared first on Almac.

Live Webinar March 28th: An Integrated Approach to Biomarker Discovery

admin — Tue, 01 Mar 2011 14:13:18 +0000

Almac’s Diagnostic Services Business Unit will run complimentary live webinar ‘An Integrated Approach to Biomarker Discovery’ on Monday, March 28th, 2011, 11.00am EDT (16.00h GMT) .

Click here to register now.

Speakers for this Event:

Max Bylesjo, Ph.D., Bioinformatics Team Leader, Almac
Nicolas Goffard, Ph.D, Bioinformatics Scientist, Almac

One of the main challenges of biomarker discovery is the unbiased evaluation and rational selection of most promising biomarkers suitable for independent validation. The absence of a robust evaluation procedure can result in selecting too many biomarkers (thus creating multiplicity problems) with biased and often too optimistic estimates of performance and with limited clinical utility.

Almac’s Approach

Almac has developed an integrated approach to biomarker model development, evaluation and selection and applied it to real life projects. This approach is implemented in classification workflow software. This allows for parallel development of multiple biomarkers models and simultaneous generation of the data used in the model evaluation procedure we are going to describe in this webinar. An important feature of this procedure is the use of both statistical and functional characteristics of the models evaluated.

While traditional approaches to biomarker model generation commonly focus on purely statistical properties, in this webinar we demonstrate how functional analysis can be used as both an essential component of biomarker discovery as well as integral part of the biomarker selection process.

Join this webinar and learn:

How some of the major challenges of biomarker discovery can be addressed in an integrated manner.
How to discover and select the biomarker models most suitable for independent validation.
The importance of functional analysis as an essential component of biomarker discovery.

The post Live Webinar March 28th: An Integrated Approach to Biomarker Discovery appeared first on Almac.

Almacs New Headquarters Takes Control of Scheduled I-V Substances Capabilities

admin — Mon, 28 Feb 2011 11:39:31 +0000

Packaging, storage and distribution of schedule I – V controlled substance is now a fully functional capability of Almac’s new North American Headquarters facility in Souderton PA. As the phased transition nears its end, the portfolio of services and capacity offered to customers continues to grow as a result of the $120 million investment.

Storage for controlled materials is located in a highly secured temperature monitored cage and vault. Both locations meet DEA requirements in addition to providing substantially greater capacity. The total 3,980 square feet of storage space comes as a response to demand expressed by both the industry and existing clients. This, as well as expansive growth in areas of storage for ambient, refrigerated and frozen products, is part of Almac’s ongoing mission to ensure drugs get to market faster.

Dave Setley, Head of Business Development, commented on the addition by saying “The expanded storage and distribution of controlled drug product from the NAHQ further solidifies Almac’s position as a leader in the clinical supply arena.”

Almac’s facility growth has also allowed the company to offer a broad range of pharmaceutical development services from the US headquarter site – all under one roof, mirroring the successful mix of services offered by the Global Headquarters in Northern Ireland. Clients can now carry out their trial supply services from the Souderton, PA location as well as IWR/IVRS and analytical services if needed. This proves to be an unparalleled advantage in the market and sets Almac aside from its competitors in the industry.

As the phased transition nears its end, Almac is busily working around the clock to make sure current projects continue without interruption. Almac invites existing and prospective clients, as well as the media, to schedule tours of the facility or learn more by visiting almacgroup.com

About Almac Group

The company employs over 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new $120m North American Headquarters located in Souderton PA.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almacs New Headquarters Takes Control of Scheduled I-V Substances Capabilities appeared first on Almac.

Almac announce Launch of Bioinformatics Consultancy

admin — Thu, 17 Feb 2011 17:32:59 +0000

Almac’s Diagnostic Services business unit today announced the launch of its Bioinformatics Consultancy service.

Almac’s Bioinformatics consultancy supports discovery and development of biomarkers as well as enabling an in-depth understanding of biology by partnering with customers in the pharmaceutical, biotech and diagnostics setting from the initial study design through to the interpretation of data results.

The consultancy service offers a range of customisable bioinformatics and biostatistics solutions which include; Biomarker Discovery and Development, Exploratory Analysis, Mechanistic and Functional Analysis, Traditional and Next Generation Sequencing Data Analysis, Biostatistics and Data Integration.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Services business unit said:

“Bioinformatics has always been a key strength for us in Almac. Over the years we have built up a world class team of bioinformaticians and biostatisticians. This team has provided invaluable support for both our internal research and our external work. The launch of the full bioinformatics consultancy business is the next logical step in enabling our customer’s to access this important resource”.

Almac has secured its position in the personalized medicine market, following collaborations with some of the top Pharma companies worldwide including Pfizer, Eli Lilly and Merck.

Contact:

Emma O’Neill

Almac

028 38 33 7575

Emma.oneill@almacgroup.com

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac announce Launch of Bioinformatics Consultancy appeared first on Almac.

Graham Nicholls of Almac Group to Speak on Adaptive Trial Designs and Clinical Supplies at CTS Europe Conference

admin — Mon, 14 Feb 2011 12:35:34 +0000

The Almac Group announced today that Graham Nicholls, Director of Biostatistics for Almac’s Clinical Technologies business unit, will be speaking at the Clinical Trial Supply Europe conference (CTS Europe) held in Barcelona, Spain, 22-23 February 2011. The conference will be attended by two of Almac’s business units directly involved with providing an integrated clinical supply chain solution involving IXRS® technology, planning, forecasting, packaging, labeling, analytical testing, inventory management, and global distribution of supplies for clinical trials.

Graham Nicholls plans to speak on the topic of the challenges of conducting adaptive trials. A notable expert on this subject, Mr. Nicholls will provide an overview of adaptive trial designs and comment on some of the current regulatory and logistical perspectives of implementing such trials on a global basis. Additionally, Mr. Nicholls will address some of the particular challenges that adaptive trial designs have on clinical supplies planning, as well as on manufacturing, packaging, and IXRS® technology considerations.

Jim Murphy, President of Almac’s Clinical Technologies Business unit comments on the unique full service clinical supply solution offered by Almac: “Graham’s knowledge of dynamic randomization strategies has helped Almac solidify its reputation as an industry leader in adaptive and other complex trial designs. Graham’s knowledge complements Almac’s logistical expertise in managing clinical supply chains on a global basis, providing our clients with a full-service drug supply management solution for adaptive trials that is unmatched in our industry. As we are seeing an increasing number of adaptive trials, it is important to share Graham’s extensive knowledge at conferences, such as CTS Europe, to help sponsors plan and execute on complex study designs.”

Almac will be showcasing its integrated technology and clinical supply chain solution at booth #19 at the CTS Europe show.

Contact:

Joseph Bedford, PhD

T: (001) 215-660-8500

E: clinicaltechnologies@almacgroup.com

W: almacgroup.com

Tristan Jervis

DeFacto

T.Jervis@Defacto.com

Tel: + 44 2078 613019

About Almac Group

The company employs over 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new $120m North American Headquarters located in Souderton PA.

Almac’s Clinical Technologies business unit specializes in interactive technology and service solutions to increase the quality and efficiency of clinical trials. Our solutions include Interactive Voice and Web Response Systems (IXRS®) for patient randomization and drug assignment, patient and clinical supplies management, electronic-patient-reported-outcomes data collection, and Web drug reconciliation. Almac’s technologies have been deployed in over 1600 clinical trials, incorporating over 1.5 million patients in over 80 countries, and more than 60 languages.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Graham Nicholls of Almac Group to Speak on Adaptive Trial Designs and Clinical Supplies at CTS Europe Conference appeared first on Almac.

Almac Opens Analytical Labs in New US Headquarters

admin — Mon, 07 Feb 2011 12:43:05 +0000

Almac’s new 240,000 sq. ft. North American Headquarters, built on 40 acres in Souderton, PA, north of Philadelphia is part of the Almac Group’s integrated services solutions strategy. The new facility delivers full-service, integrated clinical packaging, drug supply management and technology solutions to pharmaceutical and biotech clients.

The facility has state of the art analytical labs, complementing existing facilities in the UK.

The lab provides support for clinical packaging operations as well as stand-alone analytical services to our customers. The labs are equipped with the latest equipment, including HPLC, UPLC, GC, UV, IR, DSC, KF and others. The new group will also offer Polymorph and Salt Screening and Solid Form Development.

Clinical packaging projects often require a range of analytical support, from simple ‘ID testing’ to full method development and validation. Over-encapsulation (OE) is now a widely accepted process for ‘blinding’ during clinical trials. The investigational product, a potential comparator and/or placebo are blinded in hard gelatin capsules, providing visually identical products, thus removing potential bias during a trial.

Having ‘modified’ the products through OE, it is critical to confirm that quality and activity have not been adversely affected. Good manufacturing practice (GMP) requires that it be shown that the OE products will behave identically to the original products. This requires comparative dissolution and stability testing of the OE product. As these products now contain a hard gel capsule and sometimes filler, assay method development and validation is often required. The US group draws on the many years of method development and GMP experience that resides in the UK group.

Almac has installed the latest bathless dissolution apparatus for rapid and efficient comparative dissolution studies. Installation of the newest Waters H-Class HPLC/UPLC systems provides maximum flexibility for developing, validating and running assay, dissolution and stability methods. Large capacity Stability chambers provide all the required ICH stability conditions in the new labs.

Now that the analytical labs and stability chambers are in-house at Souderton, Almac offers a ‘one stop shop’, and provides an efficient and comprehensive service to our customers.

Almac’s location in the Northeast US pharmaceutical corridor has allowed for the recruitment of top pharmaceutical technical talent. Dr. Aeri Park, Operations Director for the new facility commented: ‘We have built a professional team of skilled scientists, each with extensive pharmaceutical industry experience. We look forward to supporting the clinical packaging operations and growing our stand-alone Analytical and Solid Form business‘.

The new analytical facility complements Almac’s specialty capabilities, including Biocatalysis, Radiolabeling, and peptide and protein synthesis. These services are all part of Almac’s comprehensive Drug Development Services, including API and drug product development and GMP manufacture.

For further information on Almac’s new North American Headquarters and our service offerings please visit www.findpharmony.com

Contact:

Tristan Jervis

Account Director

De Facto Communications

330 High Holborn

London WC1V 7QD

T: +44 (0)207 861 3838

E: t.jervis@defacto.com

About Almac Group:

The company employs almost 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Staff has now transferred to Almac’s new $120m North American Headquarters which is now fully operational.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac Opens Analytical Labs in New US Headquarters appeared first on Almac.

Distribution Heats Up as Almac Continues its Transition to New North American Headquarters

admin — Wed, 19 Jan 2011 12:47:47 +0000

Almac is making substantial progress in transitioning operations to its new headquarters in Souderton, PA, especially in the area of distribution. The new facility has been successfully shipping clinical trial materials since November, and has recently seen an increase in shipment volumes due to the added efficiencies the new building provides.

Material packing for trial supply shipments is now performed in Almac’s state-of-the art Pharmacy. Providing nearly 8,000 square feet of space and situated adjacent to the distribution warehouse, the Pharmacy is designed to facilitate the picking of clinical distribution orders. Technicians are able to work more efficiently using industry leading RF scanning devices, ultimately reducing processing times. Orders are verified and then packed in custom designed individual Packing Suites. A more streamlined workflow was the key component when original layout designs were being considered, and has proven to be a positive addition to the headquarters project.

Scott McCurdy, Distribution Supervisor, commented on the operations in the new facility by saying

“The Almac Distribution Department successfully ceased operations in Audubon, transferred client material and relocated staff over the course of one weekend without affecting shipping timelines. Our new facility affords Almac Distribution the opportunity to expand and provide new solutions for the global clinical trial supply chain.”

Already cleared as a TSA Certified Cargo Screening Facility, the next step for the company is to relocate their label generation, controlled substance packaging, and primary packaging operations. Almac anticipates the phased transfer, which began in November, to be complete by February 2011 sequentially making both buildings in the headquarters project fully operational. A copy of the proposed dates of transfer can be viewed by visiting the NAHQ specific microsite.

The new headquarters houses clinical trial supply and technology services as well as introducing Almac’s analytical services to the U.S. for the first time. This combination of services optimizes the clinical supply chain by providing clients with the ability to approve multiple activities at one site, in one visit. In addition, the new building offers a huge expansion in capacity for the storage of trial materials, especially refrigerated storage, where pallet space has increased by 5 times to accommodate a growing demand amongst pharma and biotech companies.

Clients are invited to take a tour of the facility or request a meeting to further discover how the new features will benefit them and their organization. For more information on the recent happenings at Almac’s new NAHQ, please visit www.findpharmony.com

Almac has taken care to keep clients fully informed regarding transition times using direct mailings, email, and information updates on the NAHQ specific website as well as personally meeting with clients to discuss upcoming plans.

About Almac Group:

The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Distribution Heats Up as Almac Continues its Transition to New North American Headquarters appeared first on Almac.

Almac wins News Flow of the Year Category at the Genesis 2010 Awards

admin — Thu, 16 Dec 2010 14:08:34 +0000

The Almac Group, one of the world’s leading contract drug development and manufacturing organisations, was presented with the

“News Flow of the Year”

accolade at the 2010 Genesis Awards annual Gala dinner in London last week, following the company being shortlisted as a finalist in the category nominations. Now into its tenth year, Genesis is established as a leading life science networking conference.

Recognised by the Genesis Awards panel as an

“ambassador for the UK life sciences sector”,

Almac’s 2010 news flow has increased exponentially compared to previous years. Messaging and announcements have been tailored to developments within the Group’s areas of expertise, which extend from research, through development to commercialisation. Over 35 new stories have already been released this year with well over 400 items of coverage secured in target trade media world-wide.

The award comes hot on the heels of a string of accolades won by Almac this year, including winning the excellence in ‘Innovation’ category at Northern Ireland’s tenth annual Belfast Telegraph Business Awards in recognition of the Group’s discovery and validation of new pioneering biomarkers in the field of personalised medicine. Moreover, Almac was rated Great Place to Work®, complete with a top five company ‘excellence in disability’ rating, by the Great Place to Work® Institute UK’.

De Facto Communications, the leading life science and healthcare communications agency, implemented a news flow communications strategy for the organisation that focused on aligning Almac’s internal proposition with external perceptions across the wider market and industry. Furthermore, the Group’s US expansion has been extensively covered in announcements and secured media exposure. This approach has enabled Almac to showcase its wider integrated offerings to a more diverse range of audiences, highlighting the Company’s size, history and corporate strengths.

Tristan Jervis. Associate Director at De Facto Communications commented: “To achieve these communications goals, a series of messaging meetings were arranged within the Group at the start of 2010. Targeted media lists and multiple expertise marketing communications plans were created, together with a Group-wide communications plan, specifically designed to capture central corporate messages. This innovative approach has enabled the company to produce a constant stream of highly targeted coverage, whilst enabling Almac to more closely mirror its internal structure externally.”

Philip Diamond, Vice President of Corporate Market Development at the Almac Group commented:

“We are very pleased to have won this prestigious accolade and for the recognition that it affords. Indeed, we have significantly increased the volume of news flow released to the media this year and thanks to the quality of these announcements, we have significantly expanded our profile in the life science and pharmaceuticals sectors whilst enhancing target audience awareness of our integrated service offering and the expansion of our US operations”.

Alan Armstrong, CEO of the Almac Group commented:

“In addition to an extensive and regular flow of business related press releases, we have also focused announcements on CSR programmes, especially our regional support initiatives. Highlights have included a focus on Almac’s history, roots and committed support for the local Northern Ireland economy; exemplified by our late founder, Sir Allen McClay, being honoured with Craigavon’s “Young Business Person of the Year” Award named after him, together with the opening of the new Queen’s University library that he privately funded.”

Contact:

Tristan Jervis

Account Director

De Facto Communications

330 High Holborn

London WC1V 7QD

T: +44 (0)207 861 3838

E: t.jervis@defacto.com

About Almac Group

The company employs almost 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has officially gained full possession of its new $120m North American Headquarters which started in July 2008 and employees are relocating during the fall.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac wins News Flow of the Year Category at the Genesis 2010 Awards appeared first on Almac.

Almac adds Late Stage Customisation Suite to assist Orphan Drug / Niche Product Launches into Europe

admin — Fri, 26 Nov 2010 14:09:35 +0000

With a growing requirement to support our clients with their EU product launches, reduce stock holdings and provide greater flexibility with regional packs, Almac has added an additional dedicated Late Stage Customisation Suite to the company’s commercial facilities.

Mark English, Distribution Manager at Almac explains, “Late stage customisation involves working with the client, understanding their country launch requirements to develop an EU regional supply strategy. Grouping countries by language allowing for multilanguage packs to service multiple markets, with country specific information added at point of despatch, provides significant cost advantages. Working with products that are manufactured in very low volumes at, often, a very high cost means that solutions to minimise stock holding are of particular benefit”.

Historically the countries grouped together tended to be based on geographical proximity to ensure that distribution to the end user was as short as possible. However with modern shipping methods this is no longer necessarily the case. The main factors now tend to be which countries share a common language i.e. UK/Ireland and Germany/Austria and having at least one of the “Big 5” (Germany, France, Spain, Italy & the UK) in each regional pack, meaning that smaller markets can be served when required without committing any stock for orders that may never arise.

Assembling regional packs results in one pack being available for as many as 5 markets, as country specific information is applied to the ‘Blue Box’ area as orders are received direct from pharmacies or hospitals. The addition of the dedicated Late Stage Customisation Suite gives Almac the flexibility to process these orders immediately ensuring just-in-time delivery.

David Downey, VP Commercial Operations of Almac explains “With our client partners, we have successfully launched many high-value, orphan drug / niche products into the European market, hitting launch timelines, and maximising product flexibility to supply multiple markets. Utilising our integrated pharmaceutical and distribution services we can provide a seamless transfer of product and services to the end-user.”

Contact:

Tristan Jervis

De Facto Communications

Tel: + 44 207 8613019

E-mail@: t.jervis@defcato.com

About Almac Group

The company employs 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has officially gained full possession of its new $120m North American Headquarters which started in July 2008 and employees will relocate during the fall.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac adds Late Stage Customisation Suite to assist Orphan Drug / Niche Product Launches into Europe appeared first on Almac.

Almac discusses its investment in biocatalysis lauding cost and environmental benefits on OutsourcingPharma.com

admin — Tue, 23 Nov 2010 14:16:15 +0000

Almac invests $4m in biocatalysis R&D, describing such technologies as the way forward for the cost efficient production of highly chiral APIs and intermediates.

Click here to listen to the podcast featuring Tom Moody, head of Almac’s biocatlaysis unit (Almac Sciences business unit).

About Almac

For more information on Almac, please visit almacgroup.com or email info@almacgroup.com

The post Almac discusses its investment in biocatalysis lauding cost and environmental benefits on OutsourcingPharma.com appeared first on Almac.

Almac and the Royal Society of Chemistry host a workshop on the use of analytical techniques to control and monitor solid form

admin — Fri, 19 Nov 2010 14:17:28 +0000

Almac, in association with the Royal Society of Chemistry, hosted a scientific workshop focusing on advanced analytical techniques used to optimise, monitor and control solid state properties during the development of new medicines.

The milestone event, attended by representatives from industry and academia, included presentations and round table discussion regarding x-ray powder diffraction, hyper differential scanning calorimetry and Raman spectroscopy.

An important element of the workshop was the presentation of results from Almac’s collaborative research with Queens University Belfast regarding Raman spectroscopy. “The effect of crystal orientation on Raman Spectra” has been observed for the first time and these findings will have profound implications for the use of this technique in characterising physical forms.

Linda McCausland, Head of Physical Sciences, Almac, commented: “Almac has invested extensively in research and development in the field of solid state science and are currently involved in a number of academic collaborations. The research output of these studies will be available to clients to augment the development of their drugs. This workshop provided an opportunity for Almac to share its expertise with the pharmaceutical community and we are very proud to have worked with the Royal Society of Chemistry in staging such an exciting event.”

She added; “We do feel that the insight from the study’s findings are testimony to Almac’s status as a leader in the field of solid state science.”

Prof Duncan Burns, Analytical Division, Royal Society of Chemistry, remarked: “The workshop was a truly memorable day of excellent and well presented analytical science”.

Contact:

Tristan Jervis

De Facto Communications

Tel: + 44 207 8613019

E-mail@: t.jervis@defcato.com

Notes to Editors:

About Almac

For more information on Almac, please visit almacgroup.com

The post Almac and the Royal Society of Chemistry host a workshop on the use of analytical techniques to control and monitor solid form appeared first on Almac.

Almacs Clinical Technologies Business Unit Again Receives `Best Places to Work in PA 2010′ Award

admin — Wed, 10 Nov 2010 14:21:59 +0000

Almac’s Clinical Technologies business unit, a part of the Almac Group, has been named one of the Best Places to Work in PA for 2010. The awards program, created in 2000, is one of the first statewide programs of its kind in the country. The program is a public/private partnership between the Team Pennsylvania Foundation, the Pennsylvania Department of Community and Economic Development, and the Central Penn Business Journal.

This survey and awards program was designed to identify, recognize, and honor the best places to be employed in Pennsylvania, benefiting the state’s economy, its workforce, and businesses.

Companies from across the state entered the two-part process to determine the 100 Best Places to Work in PA. The first part of this process was evaluating each nominated company’s workplace policies, practices, philosophies, systems, and demographics. The second part consisted of an employee survey to measure the employee experience. The combined scores determined the top companies and the final ranking. Best Companies Group managed the overall registration and survey process.

Jim Murphy, President of Almac’s Clinical Technologies’ business unit, comments on receiving the award: “Almac is honored to receive the Best Places to Work in PA Award for the second year in a row. Almac’s core values are Quality, Service, Innovation, and People. Among these values, “People” is the most critical because Almac’s employees are the key to our ability to fulfill the other three core values. In recognition of this fact, Almac invests heavily in employment development and fosters a culture that creates a positive, collaborative, and productive working environment.”

Almac’s Clinical Technologies unit will be recognized at the Best Places to Work in PA evening awards ceremony on Tuesday, November 30, 2010, at the LancasterCountyConvention Center in Lancaster, PA. Rankings will be revealed at the ceremony.

Contact:

Joseph Bedford, PhD

T: (001) 215-660-8500

E: clinicaltechnologies@almacgroup.com

W: almacgroup.com

Tristan Jervis

DeFacto

T.Jervis@Defacto.com

Tel: + 44 2078 613019

About Almac Group

The Almac Group comprises of five closely integrated business units offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

Almac’s Clinical Technologies business unit specializes in interactive technology and service solutions to increase the quality and efficiency of the clinical trial process. Our solutions include Interactive Voice and Web Response Systems (IXRS™) for patient randomization, tracking and clinical supply management, electronic-patient-reported- outcomes data collection, and Web drug reconciliation. Almac’s technologies have been deployed in over 1500 clinical trials, incorporating over 1.5 million patients in over 80 countries, and more than 60 languages.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almacs Clinical Technologies Business Unit Again Receives `Best Places to Work in PA 2010′ Award appeared first on Almac.

Almac has Successful MHRA Inspection at its Clinical Services UK Site

admin — Mon, 18 Oct 2010 14:40:33 +0000

Almac is once again pleased to announce the successful completion of an inspection of its Clinical Services UK facility located in Craigavon by the Medicines and Healthcare products Regulatory Agency (MHRA)

The routine inspection which took place over 4 days, September 13th – September 16th was conducted by a MHRA inspector from the regulatory body who concluded that the site continues to be compliant with EU Good Manufacturing Practices, with no critical or major failures observed.

Commenting on the inspection, Paul O’Connor (Vice President, Quality) said:

“We are extremely pleased with the outcome of our inspection. These successful results are a positive reflection of all the investment Almac has made over the past few years in our facilities and recruitment of the best employees ensuring that we are a market leader and continue to deliver a high quality service. Quality is at the core of our ethos – we have three MHRA approved facilities globally including our additional FDA assessed US facilities in Audubon, PA & Durham, NC. The very high standards of quality compliance will continue with our new $120 million North American Headquarters in Souderton scheduled to open during the Fall.”

Contact:

Aileen Murphy

aileen.murphy@almacgroup.com

Tel: +44(0)28 3836 2436

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,800 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has officially gained full possession of its new $120m North American Headquarters, which started in July 2008, and employees will relocate during the fall.

For more information on Almac, please visit almacgroup.com

The post Almac has Successful MHRA Inspection at its Clinical Services UK Site appeared first on Almac.

Almac Successfully Moves its Clinical Technologies Business Unit into New North American Headquarters

admin — Wed, 13 Oct 2010 14:43:40 +0000

Almac announced today that its Clinical Technologies division has successfully moved into the Almac Group’s new North American Headquarters. After groundbreaking of the 40-acre site in Souderton, PA on 23 July 2008, the drug development firm has now completed the first phase of relocating employees from three Almac business units to the new 240,000 square feet state-of-the-art integrated drug development facility.

On 11 October, Almac’s technology business unit joined employees from Almac’s analytical testing and clinical supplies units as occupants at the North American Headquarters. Over the course of the next two months, Almac will transition the remainder of its clinical supplies operations currently located in Audubon, PA, into the integrated drug development facility in Souderton, PA.

The transition of the technologies business into Almac’s new North American Headquarters was carefully planned and executed. Over the course of the past few months, Almac successfully relocated and tested all of its new and existing technologies and systems in the new locale to make certain that there were no disruptions to client studies during the transition into the North American Headquarters.

Jim Murphy, President of Almac’s clinical technologies business unit, comments on the flawless move of the business from Yardley, PA, to its new location in Souderton, PA. Murphy: “Our IT, Quality Assurance, senior management team, and other key personnel worked in unison to ensure that all of our systems were tested and met the highest standards before we moved into the new facility. The transition team’s meticulous planning enabled us to avoid any downtime on client studies outside of our normal maintenance windows. I am delighted to announce that everything went as planned with this perfectly executed transition.”

The move of three Almac business units to a new North American Headquarters is part of the Almac Group’s integrated services solutions strategy. The new facility was planned to deliver a full-service, integrated drug supply management and technology solution to biopharmaceutical clients.

Joseph Bedford, Ph.D., Director of Marketing at Almac’s Clinical Technologies business unit comments: “The biopharmaceutical industry is making great strides to streamline drug development and bring efficiencies to clinical trials. Our new North American Headquarters allows Almac to deliver an integrated clinical supplies, analytical testing, and clinical technologies offering to sponsors that is unparalleled in our industry. Working with integrated teams of drug supply management and technology specialists at Almac, our clients will benefit from the combined insights of experienced professionals who deliver efficiencies in the clinical supplies chain that no other firm can match.”

Almac’s Clinical Technologies business unit began work on Monday, October 11th at the new facility after a celebration on Sunday, during which employees unpacked their work items and were treated to lunch with families and friends of Almac. By Monday morning, it was business-as-usual at Almac, with Clinical Technologies professionals managing hundreds of live studies for clients.

END

Contact:

Joseph Bedford, PhD

T: (001) 215-660-8500

E: clinicaltechnologies@almacgroup.com

W: almacgroup.com

About Almac Group

The Almac Group comprises of five closely integrated divisions offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,800 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has officially gained full possession of its new $120m North American Headquarters which started in July 2008 and employees will relocate during the fall.

Almac’s Clinical Technologies division specializes in interactive technology and service solutions to increase the quality and efficiency of the clinical trial process. Our solutions include Interactive Voice and Web Response Systems (IXRS™) for patient randomization, tracking and clinical supply management, electronic-patient-reported-outcomes (ePRO) data collection, and Web drug reconciliation. Almac’s technologies have been deployed in over 1500 clinical trials, incorporating over 1.5 million patients in over 80 countries, and more than 60 languages.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com. For a virtual tour of Almac’s North American Headquarters, please visit www.findpharmony.com.

The post Almac Successfully Moves its Clinical Technologies Business Unit into New North American Headquarters appeared first on Almac.

Almac continues biocatalysis business growth with a further $4m R&D investment

admin — Thu, 07 Oct 2010 14:44:52 +0000

The need for green, economic, robust and scaleable processes for the synthesis of chiral APIs and intermediates prompted Almac (CPHI Booth 4F32) to build and fully integrate a biocatalysis group into its service portfolio. Last year Almac launched carbonyl reductase, transaminase, hydrolase, nitrilase, and nitrile hydratase enzyme screening kits and is continuing to both advance the biocatalysis business – and to broaden application of its biocatalysis expertise with a further $4m R&D investment.

The investment will be used primarily to focus around discovery of new biocatalytic platforms that can be rapidly implemented and scaled delivering cost effective processes to chiral intermediates. Other areas of research will investigate hyper-activation of biocatalysts reducing enzyme loadings, as well as development of efficient and robust drivers for cofactor recycle and problems with equilibriums.

As anticipated, the business has advanced from the sale of enzyme screening kits, then to screening and optimising custom transformations, and finally to the supply of 10s then 100s of kgs of chiral intermediates.

For example, preliminary screening was carried out to demonstrate that a carbonyl reductase (CRED) bioreduction could replace a resolution for the preparation of a chiral alcohol. Having identified a CRED at small scale, Almac prepared a hundred grams of the chiral alcohol and integrated it into the API process development programme.

The next step was to manufacture 30 kgs for incorporation into the GMP API manufacture for Phase I clinical trials.

The rapid scale-up from biocatalyst screening has been the critical success factor for the recent paradigm shift to bioprocessing acceptance for the synthesis of APIs and fine chemicals.

“The biocatalyst is now Almac’s first choice for scale-up chemistry involving chirality as it provides efficient, clean and robust processes. The $4m R&D investment demonstrates Almac’s continued commitment to biocatalysis, supporting further growth in our expertise and capabilities in biotechnology” notes Head of Biocatalysis Dr. Tom Moody.

“Clean-up” application:

The latest addition to the application of Almac biocatalysis expertise is for the “clean-up” of chemical reactions (Moody, T. Pharma Chem, April/May edition, 36-38, 2010). Impurities produced in multi-step processes are often difficult to remove, particularly if they are similar in structure to the desired product. When crystallisation or partition does not provide sufficient purity, Almac has used a biocatalytic process to selectively modify impurities. The impurities are then sufficiently different in physical properties from the desired product that they can be removed using conventional separation techniques.

“Biocatalysis provides a mild, regio & chemoselective process to modify impurities, thus altering their physical properties to facilitate their removal” says Tom Moody.

ENDS

Contact:

Tom Moody

Head of Biocatalysis

Almac

T: +44 (0) 28 3833 2200

F: +44 (0) 28 3833 2299

Tristan Jervis

Account Director

De Facto Communications

T: +44 (0)207 861 3838

E: t.jervis@defacto.com

Notes to Editors

About Almac Group

For more information on Almac, please visit almacgroup.com

The post Almac continues biocatalysis business growth with a further $4m R&D investment appeared first on Almac.

Almac ‘Event in the Tent’ raises £14,500 for Charities

admin — Mon, 04 Oct 2010 14:49:37 +0000

Almac staff have provided a welcome boost for two charities with generous donations of £7,250 each.

The money was raised at the Almac Group’s annual ‘Event in the Tent’, which took place recently at the company’s headquarters in Craigavon. The beneficiaries were Macmillan Cancer and the NI Children’s Hospice who were delighted with the donations.

All parts of the organisation were well represented with over 1300 staff and management enjoying the traditional celebration with a three-course meal followed by entertainment.

The money was raised through a raffle with a range of great prizes including 2 return tickets to New York courtesy of Continental Airlines, a £1000.00 Holiday Gift Voucher donated by Elpro and 3 Apple iPad’s generously provided by donated by World Courier, DHL and Faubel.

Laura Johnston Community Corporate Manager, Macmillan said: “We are delighted to receive such a significant donation. This money will be used to support cancer patients in Northern Ireland. Macmillan receives no government funding and relies on the generosity of the public and so we would like to convey our heartfelt thanks to the staff of Almac for ensuring we continue to provide our caring services.”

Claire Brown, Corporate Fundraiser, NI Children’s Hospice said: “Almac have excelled yet again with their annual fundraiser and we are delighted to be have been selected again as a chosen charity. NI Children’s Hospice relies heavily on the support of Corporate NI and this generous donation will allow us to continue providing essential care to terminally ill children and their families across NI.”

Almac Chief Executive Alan Armstrong thanked staff at the event for all their effort during the previous year but particularly for their support after the loss of the Almac founder and Chairman Sir Allen McClay.

Alan Armstrong said: “This event is our first after the sad loss of Sir Allen McClay. We remember how he always enjoyed and valued this occasion as the gathering of the Almac family. The ‘Event in the Tent’ is our way of recognising the effort of our team and it is a tradition I know Allen was tremendously proud of.

Looking forward to next year he said: “The next 12 months will be very exciting for Almac. We have recently taken possession of our new North American Headquarters facility and are working well towards full operations commencing during the autumn”.

Ends

Contact:

John Hart

Stakeholder Communications

T: 02890 339949

About Almac

The company employs over 2,800 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has officially gained full possession of its new $120m North American Headquarters which started in July 2008 and employees will relocate during the fall.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac ‘Event in the Tent’ raises £14,500 for Charities appeared first on Almac.

Almacs North American Headquarters Opens Its Doors for Audits

admin — Mon, 04 Oct 2010 14:46:53 +0000

Almac has officially begun hosting customer audits onsite at the new North American Headquarters. Nine companies have already been given a tour of the new facility by Business Development staff. Almac has also hosted three of five “audit open houses” in which multiple customers are free to attend. The audits have been well received with auditors praising the overall structure of the building and its ability to efficiently accommodate their needs.

“The tours have gone very well and the feedback has been extremely positive. Auditors have been most interested in touring the physical space of facility since it is an entirely new building,” said Mark Rohlfing, Director of Quality. “They have been most impressed with the sheer size of the facility, in particular the warehouse and cold store spaces which alone represent a 4 to 5 fold increase in capacity over our existing spaces. Almac is very proud of its new facility and hopes that clients can appreciate the added benefits it provides to them.”

One main design feature consistently noted by auditors was the overall building layout. The flow of materials and personnel was a key component in deciding the specific location of each internal department. The layout makes for a smoother transition of materials between each location throughout the supply chain. Equally impressive to guests is the high-level of design on the primary production floor, most notably the use of clean room panels, flush mounted windows, and airlocks with air pressure gradients. Many have also noted that employee workstations are well situated making maximum use of natural daylight with many affording a view of the surrounding farmland.

Auditing groups have had the chance to sit down with Almac representatives after the tours to review numerous facility and equipment qualification documents. They have reviewed SOPs, environmental monitoring protocols, and plans for relocating operations.

Additional benefits that are offered to clients is the unification of Almac’s Clinical Services and Clinical Technologies units under one roof as well as introducing its Sciences unit in the United States for the first time. In terms of a scientific presence, analytical and solid state services will be provided by Almac via 2,925 square feet of laboratory space located on the 2nd floor of Building two. The laboratories, located on the same floor as primary production, will provide analytical services, solid state services, and a write up area for up to 20 analysts. ICH compliant stability rooms are available to support the analytical requirements.

Currently, tours are being scheduled for the remainder of 2010 and into 2011. Anyone interested in scheduling a tour is encouraged to reach out to their local Almac representative or visit the headquarters website at www.findpharmony.com and clicking on “request a tour”.

ENDS:

Contact:

Jennifer Melroy

Marketing Specialist

Almac

T: +1 (215) 660-8500

E: jennifer.melroy@almacgroup.com

Tristan Jervis

Account Director

De Facto Communications

T: +44 (0) 207 861 3838

E: t.jervis@defacto.com

Notes to Editors

About Almac Group

For more information about the Almac Group, please visit almacgroup.com or email info@almacgroup.com

The post Almacs North American Headquarters Opens Its Doors for Audits appeared first on Almac.

Almacs Clinical Technologies Division undergoes successful joint GCP-GMP MHRA Inspection

admin — Tue, 21 Sep 2010 14:54:00 +0000

Almacs Clinical Technologies division announced today that it had successfully passed one of the UK’s first joint routine GCP/GMP Medicines and Healthcare Products Regulatory Agency (MHRA) inspections at its Craigavon, UK site. This involved senior MHRA inspectors from both its GCP and GMP areas assessing compliance with UK and European legislation.

The MHRA inspection was conducted on the GMP side to determine whether Almac’s IXRS integrated phone and web response system was able to adequately ensure that expired products were not shipped to sites or dispensed to patients at clinical trial sites. Additionally the system was reviewed in general terms for its compliance with Good Clinical Practices (GCP). Almac Clinical Technologies received notice from MHRA that no serious findings were found in any of these areas or others investigated by the regulatory agency.

This was the first time in its history that Almac’s Clinical Technologies division has been inspected by a regulatory authority. The inspection was conducted as part of a routine inspection plan and process of MHRA and was not triggered by any particular events, issues, or potential violations at Almac. MHRA routinely conducts inspections of both pharmaceutical companies and associated vendors who are involved in clinical trials. The results of the MHRA inspection were reported to Almac on 3 September 2010 after the company was inspected from 23-25 August 2010.

Jim Murphy, President of Almac’s Clinical Technology division comments on this significant milestone: “The highly successful results of our first-ever regulatory inspection validate the efforts of all Almac employees to deliver the highest quality GCP and GMP systems and services to our clients. We take great pride in Almac’s specialized full supply chain solution involving patient, site and drug management services, which are delivered using our IXRS technology. As patient safety is a key concern for Almac, we employ every effort to assure that patients in clinical trials are provided with products that are managed carefully to prevent expiration and meet all the requirements defined and monitored by regulatory agencies.”

Bill Kane, Director of Quality Assurance for Almac’s Clinical Technologies division, notes that Almac was not surprised by the results, given the company’s long history of delivering quality systems and services to biopharmaceutical clients. “Almac has very stringent quality SOPs that clearly define and guide the way we build systems for our clients and manage the drugs that patients take during clinical trials. The MHRA inspection validates the quality procedures that Almac has put in place and offers another testimony to our focus on providing high quality technologies and services to biopharmaceutical companies worldwide. We typically excel at client audits and now have passed another key test – an MHRA inspection.”

About Almac Group

The company employs over 2,700 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has officially gained full possession of its new $120m North American Headquarters which started in July 2008 and employees will relocate during the fall. .

Almac’s Clinical Technologies division specializes in interactive technology and service solutions to increase the quality and efficiency of the clinical trial process. Our solutions include Interactive Voice and Web Response Systems (IXRS™) for patient randomization, tracking and clinical supply management, electronic-patient-reported- outcomes data collection, and Web drug reconciliation. Almac’s technologies have been deployed in over 1500 clinical trials, incorporating over 1.5 million patients in over 80 countries, and more than 60 languages.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

Contact:

Joseph Bedford

T: (001) 267-685-4284

E: clinicaltechnologies@almacgroup.com

W: almacgroup.com

The post Almacs Clinical Technologies Division undergoes successful joint GCP-GMP MHRA Inspection appeared first on Almac.

News Items Archive - Almac

Almac Diagnostic Services Awarded Olink™ Certified Service Provider Status, Expanding Proteomics Capabilities for Biopharma Clients

Almac Diagnostic Services Expand NGS Capabilities for Clinical Trial Research

Almac adds Thermo Fisher Ion Torrent Genexus™ system to lab portfolio

Almac Group delivers record year of growth

Almac Clinical Technologies Named “Best Clinical Trial Technology Solution Provider” in 2026 MedTech Breakthrough Awards Programme

Almac Sciences Launches New cGMP Flow Hydrogenation Capability

Winter Storm impacting North America: Almac Group Update

Almac Group releases 2025 Sustainability Report

Almac announces multi-million-pound investment in Singapore

Almac Group Launches “Farm to Fork Project” in Souderton Area Schools

Almac Trial Coordinator Launched in $48 Million Investment to Advance Integrated eClinical Technologies

Almac Group launches collaboration with Young Enterprise

Almac Group Expands Bioavailability Enhancement Capabilities – Addressing a critical need in drug development

Almac Group Expands US Analytical Capacity with New Stability Chambers in Souderton, PA

Almac Group North Carolina – 25th Anniversary Celebrations

Almac completes a multi-million-pound Investment Enhancing Cold Chain Capabilities in Craigavon

Almac Group announces validated near and long-term science-based emissions reduction targets with the Science Based Targets initiative (SBTi)

Almac Group surpasses £1 billion revenue with latest Annual Accounts reporting record revenues, profit and employee numbers

Almac Clinical Services wins ‘Innovation in Distribution’ award at the Making Pharmaceuticals Awards

Almac Discovery and Formosa Pharmaceuticals announce global licensing agreement for development and commercialisation of ALM-401, a first-in-class EGFRxROR1 Bispecific Antibody-Drug Conjugate

Almac Diagnostic Services launches PNPLA3 Genotyping Kit for Liver Disease Research

Almac Diagnostic Services adds single cell sequencing to its lab services to further enable biopharma clients research needs

Almac Pharma Services Opens Doors on £65m New Commercial Manufacturing Facility

Almac Pharma Services expands with exciting career opportunities

Almac invests £500,000 in state-of-the-art instrumentation within spectroscopy laboratories

Almac Acquires Your Research to expand eClinical solutions for participants, sites and sponsors

Almac Group launches Climate Action initiative with local primary schools

Almac Group releases 2024 Sustainability Report

Almac announces key partnership with Future Medicines Institute

Almac’s Singapore facility secures GMP Certification

Almac Pharma Services announces recruitment event following major expansion at Craigavon HQ

Almac chemist recognised as “Future Leader” at CPHI Celebration Awards 2024

Almac Group announces £11m investment to expand global analytical services

Expert Analytical Solutions

Almac Pharma Services Appoints New VP Finance

Arran Chemical Company celebrates 40 successful years in business

Almac Pharma Services Joins European Paediatric Formulation Initiative (EuPFI)

Almac Announces Investment in Singapore to Enhance Cold Chain Facility for Global Pharmaceutical Sponsors and Patients

Almac Pharma Services Announces Successful FDA Inspection at Charnwood, UK Facilities

Almac Group’s power purchase agreement for renewable energy goes live

Almac Pharma Services Supports Rapid Launch of BioLineRx’s APHEXDA® (motixafortide)

Almac Pharma Services Appoints New VP of Business Development

Almac Discovery nominates ALM-401 as a First in Class Bispecific Next Generation ADC targeting EGFR/ROR1 to progress into pre-clinical development

Almac Group announces record revenue figure resulting from another year of growth

Almac Pharma Services Supports Industry Consortium to Address Titanium Dioxide Alternative Challenge

Almac Group partners with Reach Out and Read at Children’s Hospital of Philadelphia to distribute 6,000 books at CHOP Primary Care, Souderton

Amicus Therapeutics Inc and Almac Pharma Services Mark 15-year Strategic Partnership with Patient Advocacy Event

Almac Clinical Services celebrates Grace Science, LLC in dosing first NGLY1 deficient patient with their innovative gene therapy

Almac Pharma Services Appoints New Director of Manufacturing Science and Technology

Almac Group announces support of ESG category at this year’s Belfast Telegraph Business Awards

Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia

Almac Sciences awarded Life Sciences Innovative Manufacturing Fund Grant

Almac Group Awarded six 2024 CDMO Leadership Awards

Almac Group Expands Commercial Manufacturing and Packaging as well as Peptide Production Capacity

Almac Pharma Services Renew HPRA GMP Certification for European Facility

Almac Group signs virtual power purchase agreement (VPPA) for renewable energy – reducing their global scope 2 emissions by 46%

Almac Sciences extends selectAZyme™ offering to include therapeutic oligonucleotide synthesis

Almac Launches Manufacturing and Development Recruitment Drive

Almac Group awards over $120,000 in higher education funding to two undergraduate students

Almac Discovery and Queen’s University launch state-of-the-art Chemoproteomics facility in Belfast

Almac Pharma Services Receives Brazilian ANVISA GMP Certification for US Facility

Almac Group releases 2023 Corporate Social Responsibility Report

Almac Group releases details of £80 million expansion in Northern Ireland

Almac Sciences and HydRegen successfully complete first scale up of their joint development project

Almac selected as finalist for KTP “Best of the Best” awards

Almac expands Next Generation Sequencing capabilities through investment in new Illumina NovaSeq™ X Plus instrument

Almac Group grows by 150, exceeding 500 total headcount in Durham

Almac Group marks groundbreaking of $65 million facility expansion in Montgomery County

Almac Group opens a new custom-built GMP warehouse at its Global Headquarters

Almac Group Wins Life Sciences Team of the Year

Almac Group signs up to Science Based Targets initiative

Latest announcement underscores company’s commitment to be net zero by 2045

Almac Group reaches a global workforce of 7,000 as it marks most successful financial year ever

WEE1 Inhibitor discovered by Almac Discovery advanced into two clinical studies addressing the treatment of advanced solid tumours

Almac Group joins Employers for Carers to further support working carers

Almac Diagnostic Services updates claraᵀ report with significant new content for cancer research

Almac Pharma Services Hosts Recruitment Open Day in Loughborough

Almac Group Hosts Recruitment Open Day in the North West as 20 new jobs are announced

Almac Sciences and University College Dublin BROADEN Continuous Flow Chemistry Collaboration

Almac also announces 2030 emissions target – a part of its ongoing environmental strategy 