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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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 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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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.

The post Almac Announces Investment in Singapore to Enhance Cold Chain Facility for Global Pharmaceutical Sponsors and Patients appeared first on Almac.

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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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

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 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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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, 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 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.”

The post CBS This Morning Features Pfizer’s Phase 3 COVID-19 Vaccine Trial appeared first on Almac.

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

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, 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 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.

The post Almac Clinical Services Launches Virtual Auditing Solution for Clients appeared first on Almac.

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

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, 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 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.

The post Almac Group Launches Tempod® 1000 to Improve Clinical Site Temperature Data Management appeared first on Almac.

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.

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.

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, 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 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.

The post Almac Group Supports Two COVID-19 Clinical Studies in Sub-Saharan Africa appeared first on Almac.

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

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.

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. Click here to view our facilities.

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.

 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.

###

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.

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. Click here to view our facilities.

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 Group launches enhanced Label Approval Solution (LAS) appeared first on Almac.

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.

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.

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. Click here to view our facilities.

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 Group to Host West Coast Lunch and Learn Workshop Series on Adaptable Clinical Supply Chain Strategies for Biologics appeared first on Almac.

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’

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 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia. Click here to view our facilities.

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 latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com

almacgroup.com

The post Almac and Pfizer celebrate success of patient-led clinical supply model in gene therapy trial appeared first on Almac.

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

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.

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. Click here to view our facilities.

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 Group to Host Clinical Trial Supply Workshop in Germany appeared first on Almac.

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.”

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 please click here.

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.

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 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia. Click here to view our facilities.

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 Group Invites Biopharma Industry Members to Learn About Almac Adapt™ – Just in Time Manufacturing at Complimentary Workshop appeared first on Almac.

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.

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.

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.

The post Almac Group Launches Almac Adapt™ – a New Patient-centric Supply Solution appeared first on Almac.

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.

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.

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.

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.

The post Almac Group Announces Almac ONE™ – A Unified Clinical Trial Supply Solution appeared first on Almac.

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 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 17 facilities including Europe, the US and Asia.

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 latest news, follow Almac Group on Twitter and LinkedIn. 

The post Almac Group to host Clinical Trial Supply Lunch and Learn Workshop in San Francisco appeared first on Almac.

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

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.

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. Click here to view our facilities.

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 Group Invites Attendees to Join Workshop in San Diego to Learn About Cold Chain Management in Clinical Trials appeared first on Almac.

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

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.

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. Click here to view our facilities.

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.

The post Almac Clinical Services Wins Excellence Awards at 2018 Cold Chain Global Forum appeared first on Almac.

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.”

###

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.

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 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia. Click here to view our facilities.

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.

The post Almac Group Announces Successful HSA Inspection of Singapore Facility appeared first on Almac.

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.

###

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.

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. Click here to view our facilities.

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 Group Invests to Expand its Existing North Carolina Facility appeared first on Almac.

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.

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.

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.

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.

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 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.

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.

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).

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.

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.

The post Petya ransomware attack – Almac update appeared first on Almac.

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 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 Executives Share Expertise at Upcoming Industry Conferences appeared first on Almac.

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.

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.

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.

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.

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).

The post Almac Group’s Temperature Management Software Solution Receives Innovation Award appeared first on Almac.

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’

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 4,000 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.

The post Successful Inspection by FDA of Almac Clinical Services North Carolina Facility appeared first on Almac.

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’

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 4,000 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.

The post The Almac Pod™ – Changing the Dynamics of Temperature Controlled Shipping Solutions appeared first on Almac.

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.

The post Almac Group Expands Clinical Trial ‘Direct to Patient’ Service throughout Europe appeared first on Almac.

The post Almac Group Expands Asia Pacific Presence with New Regional Headquarters and Clinical Trial Supply Facility in Singapore appeared first on Almac.

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.”

The post Almac Introduce Flexible Clinical Trial Direct to Patient Solution appeared first on Almac.

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 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 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.

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 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 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.

 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.

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 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 SupplyTraQ™ Technology Solution to Streamline Clinical Trial Supply Administration appeared first on Almac.

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 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 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.

“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.

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 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. 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

The post Almac Introduce Contained Drug Handling and Bottling Capabilities in EU and US Clinical Services Sites appeared first on Almac.

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

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

The post Almac to deliver insight into Supply Chain Management at Clinical Trial Supply Europe Event appeared first on Almac.

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

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

The post Successful MHRA Inspection of Almac’s Clinical Services UK Facility appeared first on Almac.

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

The post Almac Streamline Temperature Sensitive Clinical Supplies with Enhanced Service Offering appeared first on Almac.

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:

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.

The post Almac Introduces Qualified Person Facilitation Program appeared first on Almac.

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

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.

The post Almac Adds High-Speed Clinical Trial Blistering Equipment at US HQ appeared first on Almac.

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 Steakhouse, 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

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.

The post Almac’s Clinical Trial Workshop Series to return in 2012 appeared first on Almac.

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 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 inPennsylvania, North Carolina and California.

The post Almac adds aXcess™ to its suite of services to complement clinical packaging and distribution bundle appeared first on Almac.

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 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 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.

The post New building will help Almac serve customers from Argentina to Zimbabwe appeared first on Almac.

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

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 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 Almac wins ‘The American Society for Quality’ Award in Philadelphia appeared first on Almac.

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

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 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 Almac Expands Global Coverage by Adding Depots for Clinical Trial Supply Distribution to the Asia Pacific Region appeared first on Almac.

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

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 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 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.

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.

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 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

The post Almacs New Headquarters Takes Control of Scheduled I-V Substances Capabilities appeared first on Almac.

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.

“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

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 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.

Click here to view video.

The post View our Client Message Regarding New North American Headquarters appeared first on Almac.

Souderton, Pa. – Almac has addressed ongoing industry demands by greatly expanding the storage capacity in the New North American Headquarters. Increased storage space was sparked by current trends and forecasts in the pharmaceutical industry, specifically the growing demand for biologics. Biologics, which are protein based, require cold storage to prevent degradation where as “small-molecule” drugs (non-protein based) can be stored at room temperature. Almac has made accommodations for growth by building a 271,000 cubic ft. 2-8°C cold storage facility.

“Much of the demand coming from customers has been in this area,” said Mark Rohlfing, Director of Quality at Almac. “Our current cold storage capacity in Audubon was limited, hence the 400% increase in capacity. We have also built large cold stores at our other sites in recent years to support this change.” According to a recent pharmaceutical publication, biologic ingredients are set to grow 12 – 15 percent per year to reach $12 billion by 2011. Industry analysts report that 6 of the top 10 drugs and half of the top 100 drugs in 2014 will be biologics, an approximate 2 fold increase from 2008.

Currently, Almac’s Audubon facility provides space for 400 pallets in the 2-8°C range while the new facility allows for up to 1600 pallets. Storage for 15 – 25°C products also expanded from 4200 to 6300 pallet spaces. A 6,131 cubic ft. storage unit for products between -25 to -15°C is also available, as well as mobile freezer units for products between -80 to -60°C.

Improvements are also significant in vault storage for Schedule I and II controlled substances. The vault is maintained at 15-25°C and encompasses 80,000 cubic feet, with enough racking space for 310 pallets. This is a vast increase from the current 170 pallet space offered in the Audubon facility. A limited list of personnel will have access to this area and must pass DEA background checks. With levels of theft within the pharmaceutical industry on the rise, Almac took preventative measures by establishing multiple security systems. Examples include security coded doors, alarm systems, finger-print monitored access tools and motion censored cameras.

Expansion is allowing Almac to meet the needs of clients more efficiently. “With the increasing pressure to bring products to market faster, clients will find the increased capacity a true benefit,” said Dave Setley, Head of Business Development at Almac. “From the increase in storage capacity, to the additional packaging rooms and laboratory facility all located on a single site in North America our clients will find their packaging and distribution time streamlined. Pharmaceutical and Biotech clients will enjoy the benefits of a single site from day one when they are able to approve multiple vendor’s i.e. packaging/distribution, analytical and IVRS all in one site visit.”

This increase in storage capacity is also evident across the Atlantic at the company’s EU headquarters which are located in Craigavon, Northern Ireland where 15000 square feet of 15 – 25°C storage space has been added offering an additional 625 pallet spaces.

Almac’s new headquarters is located at 25 Fretz Road, Souderton PA. Operations will transfer to the new facility during Fall 2010. For more information, visit www.findpharmony.com.

Contact:

Jennifer Melroy

jennifer.melroy@almacgroup.com

Tel: 610.666.9500

Notes to Editors

About Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), 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 2,600 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters started in July 08 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post Almac’s US Headquarters will Address Capacity Demand for Clinical Supplies appeared first on Almac.

With its academic origins and many of their key Project Leaders fully qualified pharmacists it is not surprising that the site is seeing increased partnerships with academically led Clinical Trials. Staff experienced with this specific client type are aware of the deeper level of involvement required from the outset and have an understanding of the full clinical trial process –disease state knowledge, how patients move through the hospital and pharmacy best practice when working directly with investigators. Project Leaders are also involved with writing the CTM section of the clinical protocol through to reconciling drug returned from the clinical sites at close out.

Donna Christopher, VP of Operations at Almac Clinical Services, Durham Facility commented ‘As our business continues to evolve under the Almac brand we have stayed close to our roots in academically based clinical trials – an area where our expertise lies. Alongside our core contract services, we also advise many of our clients on how to conduct their trials. From the outset we provide information on clinical input, study materials required, efficient drug kits design as well as full supply chain management in addition to providing training and monitoring to sites. We work together with our Academic clients to ensure their clinical trials are run to maximum efficiency enabling them to focus solely on their trial results. . In recent months we have doubled our capacity to enable us to meet the increased demands for our services.”

About Almac

Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.

The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters in PA started in July 08 and will be completed in 2010.

The post Almac’s North Carolina Facility Continues Growth in Academically based Clinical Trials appeared first on Almac.

This is the latest addition to the Almac Clinical Services portfolio in improving the overall clinical label approval process. Traditionally manual in scope and highly labour intensive this system development will automate the approval process and speed up the time taken to generate labels for investigational products. It will ensure all steps involved in the label approval are easily visible, traceable and actionable to users – eliminating the need for reliance on e-mail, fax and hard copy, thereby speeding up the editing process. The system includes multiple reports so users have full traceability for reviews, edits and approval allowing them to identify any bottlenecks in the label approval process and improve the overall efficiency of clinical label generation.

Key Features

The Label Approval System (LAS) has a number of key features that will enhance the overall label approval process allowing the seamless coordination of approvals among multiple approvers.

• Label proofs are automatically sent to predefined user groups
• Users have instant visibility to the status of all label approval tasks
• Automatic email notifications are sent to designated approvers when labels are available
• Identify bottlenecks in the clinical trial label approval process for future improvements.
• Online pdf mark-up brava reader tool to clearly specify changes to label design
• Automatic notification of ‘late’ tasks
• Generate multiple reports – adding transparency
• Current Status Reports – “What labels are with Almac & affiliates and for how long?”
• History Reports – “Who did what in a specific time period”
• Label Lifecycle Reports – “How long did the design, approval, changes take per label?”

Paul O’Connor, Vice President of Quality, Almac Clinical Services commenting on the launch of the new system said ‘ I am delighted to announce the launch of our new Label Approval System – we have invested significantly in the development of this new system which is the latest in a series of process improvements to remove bottlenecks in the clinical supply chain. This latest offering to our service portfolio range will be of major interest to our clients within the Pharmaceutical and Biotech industries who are seeking faster routes to get their drugs to market.’

This latest launch also coincides with the launch of a new web based Shipping Temperature Electronic Monitoring System – stems. Upon download, stems equips clinical supply professionals with immediate visibility over all crucial shipment temperature reports. This enables users to make instant decisions 24/7 on their clinical supplies without the need to monitor returns or faxing of results. Testimony to the Almac’s Groups commitment to innovation and looking for alternative methods to exceed their client expectations.

If you would like further information on the system or would like to view a demo please visit www.las.almacgroup.com.

Contact:

Aileen Murphy

aileen.murphy@almacgroup.com

Tel: +44(0)28 3836 2436

More Images can be viewed at the following link: http://www.flickr.com/photos/almac_clinical_services/

About Almac

Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.

The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters in PA started in July 08 and will be completed in 2010.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post Almac to Improve Label Approval Process in Clinical Trials appeared first on Almac.

The FDA performed the one day general inspection of the facility which included packaging, warehousing and distribution operations as well as quality systems – no 483 was issued.

Commenting on the inspection, Paul O’Connor (Vice President, Quality) said:

“We are delighted with the results of this latest inspection. It is testimony to the continued dedication and effort of our employees who ensure that our procedures and processes fully adhere to GMP requirements and the high standards set by the various international regulatory bodies. As one of our core values – “Quality” is central to our business ethos and ultimately the key to our future sustainability and success. We hope this latest announcement is of great reassurance to our clients, who ultimately rely on our commitment to provide a high quality framework to ensure their clinical trials are a success.”

Contact:

Aileen Murphy’

aileen.murphy@almacgroup.com

Tel: +44(0)28 3836 2436

About Almac

Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.

The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters in PA started in July 08 and will be completed in 2010.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post Successful Inspection by FDA of Almac Clinical Services North Carolina Facility appeared first on Almac.

“Almac Clinical Services marked the start of 2010 with the official launch of a new state-of-the-art web-based, Shipping Temperature Electronic Monitoring System – stems. Unique to the pharmaceutical and biotech industries, this latest addition to the Almac services portfolio is set to revolutionise the management of temperature controlled shipments within the clinical trial industry”.

Temperature excursions can inhibit the clinical supply chain, resulting in crucial investigational products being delayed or quarantined and not made available for immediate use at the study site. Excursions can occur at any point in a global supply chain and often arise as a result of multiple uncontrollable factors

Upon download, Almac’s Shipping Temperature Electronic Monitoring System – stems, equips clinical supply professionals with immediate visibility over all crucial shipment temperature reports. This enables users to make instant decisions 24/7 on their clinical supplies without the need for monitor returns or faxing of results.

stems reduces any quarantine time for clinical supplies at study sites, saving both time and money for a global clinical study.

stems is the latest addition to the Almac services portfolio for temperature controlled clinical supplies. Alongside the Group’s Specialist Temperature Controlled Team, and customised shipping unit systems, this new technology delivers the following key features:

Key Features

• 100% shipping temperature reports –  allowing root cause analysis for process improvements saving time & financial resources in large global trials
• Instant reporting enabling near zero quarantine time – improved inventory management whilst  saving time and reducing costs
• Fully-validated system – compliant with 21 CFR Part 11 requirements
• No return shipments required for devices, saving time and reducing expenditure
• Fully compatible with a range of browsers and requires little training
• Automated email notifications sent to predefined users
• Complex multiple alarm system programmed to match drug temperature requirement

This latest launch also coincides with a new Label Approval System (LAS) – a unique workflow-based label approval management system. LAS gives users full online review, amendment, traceability and control functionality regardless of geographic location.

Martin Lamb, Vice President of Global Business Development, Almac Clinical Services commenting on the launch of the new system: “I am delighted to announce the launch of our new Shipping Temperature Electronic Monitoring System – stems. We have experienced rapid growth in the volume of our controlled temperature shipments in the past few years. Improving visibility and performance in this area is a key goal for Almac, our clients and regulators alike, so the introduction of new, innovative tools has been a core part of our business strategy. By helping our clients achieve these goals, stems will be of major interest to Pharmaceutical and Biotech clients.’

Contact:

Aileen Murphy

E: aileen.murphy@almacgroup.com

Tel: +44(0)28 3836 2436

About Almac

Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.

The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”.  US operations are based in Pennsylvania, North Carolina and California.  Construction of the company’s new $112m North American Headquarters in PA started in July 08 and will be completed in 2010.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac Launches New STEMS System to Transform Temperature Controlled Shipment Monitoring in Clinical Trials appeared first on Almac.

This expansion has greatly increased storage capacity for clinical supplies with an additional 3,000 pallet locations and is part of global growth across the Almac Group in recent months. This includes the completion of a specialist clinical supplies storage facility in Craigavon, U.K. and the ongoing development of a 240,000 square foot North American headquarters facility in Pennsylvania on target for completion in 2010. This new facility will initially house Clinical Services and Clinical Technologies operations with expansion from other divisions in the Almac Group.

The new facility in Durham, NC was built to accommodate increased demand in outsourcing of clinical supply management services from Biotech and Pharma organisations. It will also ensure that synergies between Clinical Services and Diagnostics are fully realised for the benefit of clients. This additional facility, along with existing capacity, will increase the Durham campus to almost 138,000 square feet; more than double the size of their original operations.

Donna Christopher, Vice President of Operations at Almac Clinical Services, Durham site said: “This latest investment by Almac will act as a platform for us to serve the increasing demands of our client base who are seeking faster routes to get their products through the clinical development process. We now have 200 employees at our North Carolina operations which is more than five times the number we had when we first started out in 1998 with a team of 35. With over 20 years experience in clinical supply management Almac are recognised as a strategic partner in the clinical supply process by most of the world’s pharma and biotech companies. This increase in capacity is a sign of our commitment to offer market driven solutions to our customers.”

Contact:

Aileen Murphy

Tel: +44(0)28 3836 2436

Photo Captions:

More Images can be viewed at the following link:

http://www.flickr.com/photos/almac_clinical_services

About Almac

Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.

The company has over 2,500 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters in PA started in July 08 and will be completed in 2010.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post Almac Doubles Capacity at North Carolina Facility appeared first on Almac.

The group today announced the opening of an additional storage facility at its EU headquarters in Craigavon to meet the increased demands for cold-chain & controlled clinical supply storage.

The huge new facility has been fuelled by unprecedented demand in the marketplace for provision of supply services catering for Biotech / Pharma companies that require refrigerated or controlled storage requirements for their clinical supplies.

This new purpose built facility contains a 1277m³ vault, holding an additional 150 pallet spaces for controlled drug storage. The facility provides 450 extra pallet spaces for storage of refrigerated material (2-8°C), with room for an additional future expansion of 400 pallets. This extra capacity is in addition to that already available at the site.

This latest development is in line with Almac’s continued expansion plans, as already reflected in the significant expansions for cold storage at the groups Durham (NC) and Audubon (PA) sites. This new state-of-the-art facility combined with Almac’s global depot network ensures Almac continues as a world leader in the provision of clinical supply services and solutions.

Robert Dunlop, President of Almac Clinical Services commented ‘The opening of the new storage warehouse is a testimony to our commitment to providing the highest quality of service and available capacity to our customers. As demand for both controlled drug and cold chain storage has grown steadily in recent times, we must provide our offerings in line with market demands. This positions Almac firmly as a market leader for clinical supplies, offering unrivalled cold chain & controlled drug resources for our client base.’

About Almac Clinical Services

Almac Clinical Services is a global company focused on clinical trial supply solutions, with sites in Craigavon (UK), Audubon (PA, USA) and Durham (NC, USA). Almac Clinical Services enables clients to meet their trial start dates by leveraging skilled and experienced personnel coupled with robust quality systems and operational flexibility. Services provided include blinding, packaging, labelling, global distribution, QP release, analytical testing, drug supply management and online randomization.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

The company has almost 2,200 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100m North American Headquarters started in July 08 and is expected to be completed 2010.

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The post Almac Continues Global Expansion of Clinical Supply Services with Huge Facility for Specialist Storage appeared first on Almac.

Intelligroup was selected for the project following a rigorous five month process.  The multi-million dollar agreement, which represents the first time the two companies have worked together will include approximately 50 resources working for a period of 18 months.

“Selecting a partner who possesses a comprehensive understanding of our business and strong skills across all phases of the life cycle with Oracle E-Business Suite® Release 12 implementations was of paramount importance to us,”

said Dr. Robert Dunlop, Managing Director of Almac Clinical Services.

“Intelligroup presents an excellent strategic partner for this project, demonstrating a thorough understanding of our business and ERP and a track record of executing Oracle rollouts across all phases of implementation.”

“Intelligroup is very pleased to have been selected by Almac,”

stated Vikram Gulati, President & Chief Executive Officer of Intelligroup.

“Our fundamental focus is on our clients, and I believe our ability to help clients achieve business value with Oracle solutions is unmatched in the industry.  The expertise of our Oracle team, along with that of our Life Sciences practice, were instrumental in securing this project.  We are committed to meeting the objectives of the COSMOS project and look forward to a long and successful partnership with Almac.”

About Intelligroup, Inc.

Intelligroup is an ERP-focused enterprise applications systems integrator providing consulting, implementation, testing, application management and other IT services for global corporations. The Company possesses deep expertise and proprietary tools in industry-specific enterprise solutions and has been recognized by clients, partners including SAP and Oracle and IT industry analysts for consistently exceeding expectations. Intelligroup won the 2007 global annual Pinnacle Award from SAP, was a finalist in Oracle 2007 Titan Awards, and was recognized by NASSCOM as a Top 100 Innovator. Intelligroup’s global service delivery model combines onsite teams and offshore development capabilities to deliver solutions that accelerate results, reduce costs and generate meaningful ROI for clients. Intelligroup clients include Varian Medical, Reckitt Benckiser, Royal Greenland, SAP, GE, Magellan, Hershey’s, Eastman Chemical and Hitachi.

About Almac Clinical Services

Almac Clinical Services is a global company focused on clinical trial supply solutions, with sites in Craigavon (UK), Audubon (PA, USA) and Durham (NC, USA). Almac Clinical Services enable clients to meet their trial start dates by leveraging skilled and experienced personnel coupled with robust quality systems and operational flexibility. Services provided include blinding, packaging, labelling, global distribution, QP release, analytical testing, drug supply management and online randomisation.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

The company has over 2,200 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100m North American Headquarters started in July 08 and is expected to be completed 2010.

To find out more about Almac visit almacgroup.com

For more information, please contact:

The post Intelligroup Secures Multi-Million Dollar COSMOS Implementation with Almac Clinical Services appeared first on Almac.

Almac Clinical Services, which employs 576 people in Craigavon, and is one of the key divisions at the Almac Group, has this month reached its twentieth year of operation. The Clinical Services division was founded in 1988 and has grown to become the largest and one of the most successful parts of the Almac family.

Originally operating with two employees in one location in Craigavon, the company now employs 1100 skilled individuals across three main operational centers – Craigavon (UK), Audubon (PA) and Durham (NC) in the US.

Almac Clinical Services has enjoyed exceptional year-on-year growth and continues to out-perform in the clinical supply marketplace in what has become an ever more challenging and competitive environment globally. The ongoing success has been built on a solid platform of providing service excellence to all clients irrespective of size, with Almac’s highly skilled and dedicated staff working within a quality ethos across all sites.

As Almac Clinical Services enters its third decade of operations, the company is now firmly established as a market leader in provision of world-class clinical services. Almac has recently announced further expansion with a new $110m North American Headquarters in the US, which will create hundreds of additional new jobs in Pennsylvania as well as further opportunities for existing staff.

Commenting on this milestone, Almac Clinical Services MD Dr Robert Dunlop said: “When we began trading as Clinical Trial Services, we competed in the market by offering all of our clients exceptional customer service. Although the service we provide has been complemented as technological and other advancements are made, that core commitment to customer services remains as strong as it was twenty years ago.

“Many of the staff who founded and contributed to the progress of our company are still with us today and have helped ensure Almac Clinical Services continues to occupy the market leading position it acquired many years ago.”

“We congratulate all of those who have worked here over the past twenty years, both our dedicated staff and faithful clients alike. I am confident that over the next twenty years and beyond we will continue to develop the services that our market deserves and that our dedication to service will remain as strong as ever,”

he added.

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Contact:

Jonathan Calderwood

E: Jonathan.calderwood@almacgroup.com

T: +44 28 38 363857

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

The company has almost 2,200 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100m North American Headquarters started in July 08 and is expected to be completed 2010.

To find out more about Almac visit almacgroup.com

The post Key Almac division celebrates 20 years of growth appeared first on Almac.

This was the final inspection covering the group’s main sites for clinical supplies and follows those performed at their Craigavon (UK) and Audubon (PA) facilities within the last 4 months.

The voluntary inspection, which occurred on 21st and 22nd November 2008, observed that the Durham site was fully compliant with EU Good Manufacturing Practices, with no critical or major failures noted.

Commenting on the global significance of the inspections, Paul O’Connor (Vice President, Quality) said:

“The inspection at our Durham site is the third and final outcome in demonstrating global GMP compliance for Almac Clinical Services. Once again we have proven our company wide attitude towards a total quality ethos and this has been reflected in the results of the recent inspections. I would like to thank all of our staff for their hard work towards achieving this success.”

Robert Dunlop, President, Almac Clinical Services, added

“Congratulations to all staff across our three sites who have put significant effort into the design and implementation of our quality systems. This result gives our client base an assurance of high standards and consistency across all of our operational sites. Quality is one of Almac’s core values and we use the strength of our systems, facilities and people to differentiate ourselves in the marketplace.”

End

About Almac Clinical Services

Almac Clinical Services is a global company focused on clinical trial supply solutions, with sites in Craigavon (UK), Audubon (PA, USA) and Durham (NC, USA). Almac Clinical Services enables clients to meet their trial start dates by leveraging skilled and experienced personnel coupled with robust quality systems and operational flexibility. Services provided include blinding, packaging, labelling, global distribution, QP release, analytical testing, drug supply management and online randomisation.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

The company has almost 2,200 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100m North American Headquarters started in July 08 and is expected to be completed 2010.

To find out more about Almac visit almacgroup.com.

Contact:

Jonathan Calderwood

Jonathan.calderwood@almacgroup.com

+44 28 38 363857

The post Almac Clinical Services milestone achievement as full GMP compliance achieved across global sites appeared first on Almac.

The inspection was conducted from the 22nd to the 25th September 2008 and noted that the site was compliant with EU Good Manufacturing Practices, with no critical or major failures observed. This follows the recent successful voluntary inspection of Almac Clinical Services, Pennsylvania.

Commenting on the inspection, Paul O’Connor (Vice President, Quality) said: “We are extremely pleased that our UK operations have also undergone a positive and successful inspection by the MHRA. We have been providing clinical services from our European facility for twenty years and continue to see ourselves as a market leader in delivering quality services to our Pharmaceutical and Biotech clients alike.”

Paul added “I wish to thank all of the staff involved for their efforts in regards to this inspection. Both this outcome, along with the successful inspection of our Pennsylvanian facility, places Almac at the forefront of providing quality clinical supplies worldwide.”

Ends

Contact:

Jonathan Calderwood

Jonathan.calderwood@almacgroup.com

+44 28 38 363857

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

The company has almost 2,200 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100m North American Headquarters started in July 08 and is expected to be completed 2010.

To find out more about Almac visit almacgroup.com

The post Almac Clinical Services Craigavon Facility Achieves Successful Inspection by MHRA appeared first on Almac.

The voluntary inspection, which occurred on 15th and 16th September 2008, noted that the site was compliant with EU Good Manufacturing Practices, with no critical or major failures noted.

Commenting on the inspection, Paul O’Connor (Vice President, Quality) said:

“We are delighted with the results of this inspection. Almac has always strived to ensure that our procedures and processes meet the high standards set by the various international regulatory bodies. We find this is of great reassurance to our clients, who often require clinical services on a multi-site basis.”

Paul added

“I wish to thank all of the staff involved for their efforts and dedication in providing a robust and transparent quality framework across all of the Almac Clinical Services sites.”

The MHRA is also inspecting Almac Clinical Services Durham (NC) and Craigavon (UK) facilities.

Ends

Contact:

Jonathan Calderwood

Jonathan.calderwood@almacgroup.com

+44 28 38 363857

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

The company has almost 2,200 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100m North American Headquarters started in July 08 and is expected to be completed 2010.

To find out more about Almac visit almacgroup.com

The post Successful inspection by MHRA of Almac Clinical Services’ Pennsylvanian facility appeared first on Almac.

Almac Clinical Services launched WebEZ™ in 2006 to provide sponsor companies with a configurable web-based randomization system that can be rapidly deployed in days rather than weeks.

This perceived gap in the market for swift-to-deploy randomization systems has grown and now is reshaping the market itself , delivering very clear benefits to Pharma and Biotech companies alike.

WebEZ™ has delivered over 100 web based randomization systems, thus playing an integral part in reducing the time frames and costs required to drive innovative products to market. By using a configurable approach rather then relying on custom programming, much of the manpower and associated timelines required for system development can be removed.

Commenting on this key milestone, Donna Christopher (VP, Operations) says

“We are obviously proud that WebEZ™ has reached this significant milestone. We have a unique offering in the marketplace, deployed by a single Project Manager, who also delivers clinical supply packaging and distribution, alongside drug supply management. This is a truly differentiating factor within the market and that’s why we look forward to our next 100 systems.”

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Contact:

Carl Whyte

Stakeholder Communications

+44 (0)28 9033 9949

The post WebEZ™ reaches a key milestone appeared first on Almac.

The current global nature of clinical trials and the push towards new markets continues to pose fresh challenges. Never has it been more crucial to understand how the clinical supply chain must be managed to access these new markets, be equipped to assess the pitfalls associated with less developed countries and identify what can be done to combat these weaknesses. We look at the relationships between all parties involved in the clinical supply chain and what their roles contribute to successful global IMP distribution.

The challenges presented to every distribution manager for the shipping of clinical trials materials to emerging markets are often identified early with the customer. Patient recruitment is now spreading to countries that have not previously had access to clinical trials. There are also countries that, although clinical trials have been established for three to four years, still present challenges to the IMP professional due to the existence of challenging regulatory systems.

Many new trials are being located in countries that often do not have a robust infrastructure or a regulatory system that is tailored for clinical trials. Together these factors produce many of the common pitfalls often associated with emerging markets. China, India and regions such as Eastern Europe, South America and South East Asia all present their own unique challenges to distribution.

Factors leading to globalisation include countries that have now developed economically and have significant populations that can offer excellent patient recruitment opportunities. There is also a greater awareness of clinical trials. Eastern European countries, inaccessible for over 50 years, now offer significant patient recruitment potential and more opportunities to expand the reach of the clinical supply networks than ever before, despite regulatory challenges.

DIFFICULTIES FOR IMP LOGISTICS

With new countries and economies come the difficulties of distribution. Studies that are distributed to multiple countries will be subject to different conditions, both environmental and regulatory. Depending on the geographical location of a country, challenges include:

• • Temperature conditions for shipments: cold chain shipments in warm climates (and vice versa) must be managed effectively to ensure a successful delivery and a reduced rate of out-of-specification shipments.
  • Obtaining import licenses: this can be a lengthy process involving two or more parties, and coupled with the eventual customs clearance processes mean that communications are tested at various critical stages. If the communications fail there is a risk that the consignments are not cleared in time for resupply to the patient?

TEMPERATURE ISSUES FOR SHIPPING

Many clinical trials now involve some aspect of temperature control – either cold chain or controlled ambient conditions. These factors can complicate an already rudimentary system. A good level of trained personnel in countries that have to handle temperature-sensitive shipments can be a scarce resource. Getting the in-country depot to use a local courier familiar with temperature-sensitive cargo is a challenge in itself. Customs in these emerging countries may decide to open the shipments or hold them despite the best efforts of the consignee. Being at the mercy of these organisations and the inconsistencies in the regulations or how they are applied at ports of entry is frustrating and time consuming.

IMPORTATION ISSUES AND PAPERWORK

If temperature complications can be overcome, there are additional paperwork difficulties to resolve. The quantities of drug required for a study may change as the study progresses, perhaps due to the stock predictions being inaccurate or because patient recruitment is better than expected, or extended. The import license will have a set drug quantity and usually a time limit of 12 months (although this varies from country to country). To extend this requires a further application to import additional trial supplies. The paperwork aspect of trial material importation is every bit as vital as the CTA and product specifications files and so needs appropriate management.

DISTRIBUTION STRATEGY

Global supply chains are becoming increasingly challenging. There are a number of approaches that can be combined to create an effective supply chain, and these are best dictated by country, trial material restrictions and transit times for each study.

CENTRAL STORAGE

A central master depot situated in a region that can act as a hub to distribute materials to several countries may solve some of the supply chain problems. The central master depot can perform storage and distribution operations so that individual investigator sites can be reached efficiently with a reduced transit time from depot to site. This has the advantages of reducing the exposure to risk of temperature-sensitive products being in the supply chain and also improves the response time for resupply to the patient.

IN-COUNTRY DEPOTS

There can be regulatory requirements or distance restrictions that necessitate the contracting of a third party to hold bulk stocks of clinical trial materials. This is to overcome the repetitive nature of paperwork for dozens of shipments into the country in question. Sending a bulk order to a depot and then having a pick-and-pack operation can overcome the amount of work required to get individual shipments to the investigator sites.

On occasion, the distributor may be located on the other side of the globe in comparison to the region where the study is being conducted. South East Asia is an example of this. Country regulations are not an issue in themselves, but shipping and distributing temperature-sensitive or large numbers of site deliveries means that a depot located in

this region is a solution. One bulk shipment and a pick-and-pack operation from country to country provides one solution.

Local depots present their own hurdles such as language, time zone differences, culture and differing interpretations of quality standards. The challenge is choosing the correct solution.

CUSTOM PITFALLS, CASE STUDY AND BEST PRACTICE

Russia is an example of a country, which has repeated difficulties as a shipping destination, with extensive bureaucracy surrounding the importation of shipments. There are differences in paperwork depending on which brokers and indeed which couriers are used. Shipments are often opened by customs officials and not always released within the timeframes specified.

Access to temperature-sensitive cargo may be limited when these are held in customs areas for clearance. The most effective method to deal with this situation is to establish communication with a broker that, by reputation, does perform well with clinical trials. Keep shipments to a single broker who becomes familiar with your paperwork and presentation of documentation. This is the best method for working with Russian customs; they will not stand for any deviation in documentation and will examine every aspect of your shipments.

THE USE OF DEPOT MANAGEMENT

Setting up a depot management function to deal directly with third-party distributors can be advantageous. The management of the depots includes the provision for setting up and maintaining commercial and technical agreements, along with micro-management of the supply chain and inventory at the depots. Depot management as a function needs to be included in general study set-up practices, and to be a proactive approach implemented by being involved with the customer and depot network from as early a stage as is practicable. It can lead to expertise being shared in this area and become a central point of contact for all parties concerned.

USE OF IVRS TECHNOLOGY

The use of IVRS to facilitate management of the global inventory is a well-documented tool in the clinical supply armoury. This asset has been proven to work effectively with the distribution process to ensure that stocks in central and local depots are monitored, and that resupply is conducted in a timely fashion. The ability to track and trace the drug and ancillary stocks allows both the distributor and the sponsor to proactively manage the studies and to utilize resources where they should be ahead of the curve.

RELATIONSHIPS

Countries new to clinical trials will continually test the resolve and ingenuity of sponsor, courier and the depot. Therefore, the relationships between these entities are critical to the success of the supply chain. Third parties such as independent brokers can be consulted – this knowledge is invaluable in assessing the emerging country.

These various organisations must build effective communication and take advice from those within the supply chain that have experience in new countries or have identified key areas in the regulations that must be adhered to.

CONCLUSION

The hazards and frustrations of distributing clinical trials material to emerging markets are encountered daily by distributing organizations. Effective points of communication are the key to succeeding in emerging markets. Centralising the management of distribution to internal departments, such as depot management teams, will assist in the overall operational efficiency of the supply chain and provide effective communication with third parties.

T: +44(0)28 3836 2436

The post The Power of Communication appeared first on Almac.

Almac Clinical Services largest ever supply of clinical trials material has landed in Manila, Philippines to be delivered to investigational institutions across the region. The shipment, which weighed some 65 tonnes, is Almac’s largest ever cargo shipment.

In order to meet the requirements of the trial, and the delivery of the product, it was necessary to charter a commercial freight Boeing 747 Jumbo Jet. Individually insulated pallets were packed to provide strictly controlled temperatures of between +10°C and +30°C during shipment as required for the product. Thanks to a good working relationship between the courier and airlines, the goods cleared customs smoothly. The trial supplies have been transported to a number of clinical trial locations across South Asia.

The preparation of patient supplies also utilized Almac’s automated label verification system, to check the 320,000 labels rapidly for production. Andrew Scott, Logistics Manager, Almac Clinical Services said:

“I am delighted with the success of this delivery and am confident that our extensive logistical efforts will ensure that the clinical trial materials reach as wide a population as possible.”

“The order also required a tremendous effort from the operational and project management teams within Almac Clinical Services. The labeling and packaging of the 45 tonnes of clinical material over 22 operations was scheduled at short notice and required huge flexibility in terms of man hours and effort required.”

“We could not have managed this large operation without the flexibility and dedication of our staff from across all of the departments within Clinical Services.  I am very thankful for their time and hard work in contributing to the successful delivery of supplies for this important clinical trial.”

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors. The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The post Largest Ever Clinical Trials Cargo Shipped from Northern Ireland appeared first on Almac.

As clinical supplies and supporting services has become a truly global market, Almac continues to see itself at the forefront of current thinking and innovation. Almac personnel have chaired, presented, hosted and facilitated events spanning the globe – from San Diego and Philadelphia to Amsterdam and Copenhagen. As well as key clinical supply events, Almac has also presented to several FDA Symposium events held in New Jersey and Maryland, USA.

Almac adopts a positive approach to sharing knowledge and best practices with industry peers. Insights and ideas can only be found by meeting with clinical supply groups wherever they meet globally and assisting with the common push to deliver investigational products to investigators and sites in the most efficient way possible.

Commenting on the recent successful events, Robert Dunlop (President, Almac Clinical Services) said

“Almac makes great progress by speaking and listening to its customers and stakeholders. It is important that this is a two-way process and that we can share our thoughts and experiences with our peers. Of course this may assist in improving our clients service levels within their own clinical supply chain and they may help in turn improve the processes and practices within Almac.”

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Contact:

Carl Whyte

Stakeholder Communications

+44 (0)28 9033 9949

The post Almac at the center of industry thinking appeared first on Almac.

Paul O’Connor, Vice- President of Quality and Qualified Person (QP) delivered the keynote address during a David-Begg Associates gathering on 12th July 2007. Over 70 industry QPs were present at the event, entitled

“Strategic Issues for the Pharmaceutical Professional”,

which took place on 12th July in York, United Kingdom.

During the invitation only seminar, Paul discussed the challenges faced by QPs in today’s industry. The presentation also reviewed the Clinical Trial Directive EU 2001/20/EC and examined the roles and responsibilities of the Qualified Person post-directive.

Paul said:

“There are many stakeholders within our marketplace and it is of immense benefit to share expertise and experiences, particularly regarding the legislative framework which affects us.”

“Within Almac, we continually share our knowledge with our client base, but importantly also with the wider clinical and pharmaceutical audience with whom we play a critical role in the drug development process,”

he added.

Ends

Contact:

Carl Whyte

Stakeholder Communications

07841 970678

The post Almac present on Investigational Medicinal Products to leading Industry body appeared first on Almac.

Jonathan Calderwood, Global Marketing Manager, Almac Clinical Services

What is your career background?

I studied Biochemistry at Queens and then completed a Postgraduate in Computer Science. After graduation in 1994, I started working at the old CTS division of Galen, which is now Almac Clinical Servcies. My first job was as a Production Supervisor and I did find working full time a bit of a shock to the system. The role gave me a great insight into the operations side of the business and it was also a crash introduction into managing people. I then moved to a Project Management role which was much more customer focused; this position gave me a clear understanding of the size and potential of the markets Almac operates in across Europe, North America and further afield. I was then appointed Business Development Manager for Europe because of my experience across different parts of the company. Since we deal with multi-national pharmaceutical companies its important to have the proper technical knowledge which I’d gained through my early experience at Almac. My new role involved a lot of travel, and as Almac evolved into a fully global business I was then appointed to my current position as Global Marketing Manager.

What was your first job and how much were you paid?

My first job was at the Roads Service in Hyde Bank when I was a student, I worked as a general dogs body and answered the phone. Not too challenging but it paid well!

Have you ever had a job you hated?

I once spent a few weeks working at an amusement park in the US where my role was to stand as a target for visitors to throw rubber ducks at. Thankfully things have improved since then.

What was your first success in the business?

My first break in Almac was when the old CTS division invested a huge amount in a new facility and I was given a crack at writing the procedures for the new operation. I had to think about how the operations worked, how the facility could function to its optimum, even how the people got to their workstations when they clocked in. This sparked my interest in operations and gave me an understanding of how it can drive success and competitive advantage in a company.

What business figure(s) do you most admire?

The people I most admire are local business figures, big and small, who’ve had to put up with so much for so long. I hope that now that things have turned around in Northern Ireland that these entrepreneurs can benefit from their long-term commitment. Northern Ireland wasn’t a stable place and this factor, combined with a small population made it difficult to start a business. Still, many local people still took risks and managed to make their business a success.

Have you ever made a big mistake in business and if so what did you learn from it?

I haven’t made any drastic mistakes but lets just say I’m constantly on the learning curve. In this job you learn your lessons and don’t forget them.

What is the most valuable piece of business advice you have ever been given?

That the most important thing is to think outside our own area and our comfort zones. The impact of China and India will be huge and we now have to compete on ideas which can only be generated by thinking this way. That’s why its always vital that we bring our own concepts to the table to give us that extra competitive advantage.

What one item would you take with you to a desert island and why?

Although definitely not an ‘item’, I’d take my wife Claire with my son Ben in her backpack. And if that wasn’t allowed, my trusted iPod.

What has been your biggest financial extravagance?

My biggest extravagance is my music collection which is currently enjoying a period of unstoppable exponential growth. At the moment it looks like I might have to move some into the attic.

Do you have a business mantra?

There are so many floating around that’s its hard to pick but the most important thing is to be yourself. People may be able to replicate systems and technologies but they can’t replicate personalities and relationships.

What items do you always carry with you?

My Blackberry has become vital. I’ve been totally sucked in and find it hard to believe we ever operated without one.

When will you retire?

Hopefully next year, but that isn’t looking likely. I think most probably whenever the situation presents itself.

The post Almac Clinical Services Feature in “The Big Question” appeared first on Almac.

Kristina Spitler, Training Manager at Almac Clinical Services’ facility in North Carolina, is speaking at the upcoming FDA Regulatory and Compliance Symposium “Managing Risks – From Pipeline to Patient”. The Symposium takes place August 22nd through 24th at Harvard University.

Kristina will lead a seminar discussion on designing effective training to meet FDA requirements. The FDA issued over 40 warning letters last year for inadequate training. Kristina’s seminar, entitled

“Really Trained or Reportedly Trained?” will discuss what FDA warning letters say about the effectiveness of corporate training programs and how to develop training that delivers more than just “documented training”.

“At Almac, our core values are centered around people, and it follows that we place special importance on designing training programmes which exceed regulatory requirements and are stimulating and relevant for our employees. I look forward to sharing our expertise and experience at the Symposium this Summer,”

said Kristina.

Kristina will also present a similar subject involving GMP training effectiveness at a FDA News audio-conference on June 26th.

Ends

Contact:

Carl Whyte

Stakeholder Communications

07841 970678

The post Almac Clinical Services to present at FDA Symposium at Harvard University. appeared first on Almac.

Almac Clinical Services has today launched two Clinical Trial supply systems that are new to the marketplace and will significantly remove bottlenecks within the supply chain process.

Almac Clinical Services has developed a new system of automated label verification. The Almac system was introduced following analysis of the current industry practice of 200% manual checking of both fixed and variable text on clinical trial study kit labels, and included discussion on how lead time could be reduced. Almac ‘s new system effectively removes the requirement for manual checking of study labels, greatly enhancing their speed of availability and provides a more robust audit trail. The label verification system is pioneering in that variable content including randomization details are checked and verified by the system as well as industry standard fixed text checking.

Almac Clinical Services have also introduced a fully automated modular over-encapsulation system that provides a significant addition to the tools available for blinding of comparator products in clinical trials. This system removes the requirements for individual tooling for each tablet shape/size resulting in improved timelines and hence start dates of the clinical trial.

These projects are aimed at redefining the clinical trial supply chain and build on Almac’s already strong portfolio of industry leading services designed to aid and assist in the development of new medicines.

Robert Dunlop, President and MD, Almac Clinical Services said: “These projects are further evidence of our success in designing services which deliver industry leading solutions into the marketplace. We have identified bottlenecks that are common within the clinical supply chain and targeted our solutions to these two key areas. We are confident that our automated label verification system and new array of comparator blinding options will assist in ensuring trials are started on time and lead times are shortened to bring drug to market.”

The post Almac Launches New Innovative Clinical Supply Systems appeared first on Almac.

The workshops illustrated a new approach to the clinical trial supply chain in an integrated manner, concentrating primarily on the relationships between trial supply provision and implementation of IVRS (interactive voice response) systems The speakers included experts within both disciplines from two Almac divisions, Clinical Technologies and Clinical Services. The Almac team provided delegates with a deeper insight on how they can manage these supply chain relationships to aid the delivery and implementation of their clinical trials.

Each daily workshop consisted of presentations on each subject area, question and answer sessions with work through case studies. Almac shared experiences and expertise surrounding the significant areas of overlap between clinical trial supplies and management of IVR Systems. Clients were able to learn how they can effectively manage these areas of interface and what types of approach can be adopted for both trial supply provision and IVR systems.

Over 100 delegates attended the workshops, representing 62 different Pharmaceutical and Biotechnology companies globally that have benefited from Almac’s educational program.

About Almac

Almac offers a full range of clinical technologies and trial supply solutions that improve the quality and efficiency of the clinical trial process. Our offerings range from clinical supply packaging and management, phone and web based IVR system, global distribution, and EDC services.

ALMAC and its affiliated companies (Almac Diagnostic Services, Almac Sciences, Almac Clinical Services, Almac Clinical Technologies and Almac Pharma Services) provide a broad range of services across drug discovery, diagnostics, pharmaceutical research and development, manufacture of API, clinical trials and drug product manufacture. US operations are based in Pennsylvania, North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh.

integrated@almacgroup.com

T: +44(0)28 3836 2436 (UK enquiries)

T: +1 267 685 4284 (US enquiries)

-Ends-

The post Almac Hosts Successful Clinical Supply Management Workshops across North America appeared first on Almac.

Almac Clinical Services have announced further additions to their global distribution depot network. The company has signed a new distributorship agreement with a major commercial Pharmaceutical distributor covering the South-East Asia region. The hub facility in Singapore covers IMP distribution across South-East Asia, including Malaysia, Taiwan, the Philippines, Korea and Thailand.

Also, further agreements are now operational in China and India, two key emerging markets within the clinical trials Industry. These agreements are another major boost to the range and breadth of service offered by Almac for global IMP distribution.

Logistics Manager Andrew Scott said:

“We are delighted to add these territories to our global depot network. These will enable us to offer our clients extensive coverage for any future trials that may be performed in these regions. We have effectively responded to the market need to offer GMP compliant distribution services within these key clinical trial countries, and have greatly improved our offering to prospective clients.”

Robert Dunlop, President and MD, Almac Clinical Services said:

“This move forms part of our overall strategy to provide a range of clinical trial services globally to our clients. The opening of emerging markets in the clinical trial industry requires companies with a global presence to ensure effective reach for shipping of patient supplies worldwide.”

These additions build on an existing depot network located across the world including Russia, Ukraine, Argentina, Mexico, Brazil, Peru, Chile, Israel, France and Australia.

-Ends-

Contact:

Jonathan Calderwood

Global Marketing Manager, Almac Clinical Services

+44(0)28 3836 2436

jonathan.calderwood@almacgroup.com

Carl Whyte

Stakeholder Communications

+44 (0)28 9033 9949

The post Almac distribution network now worldwide appeared first on Almac.

The company held a 10th anniversary gala dinner hosted by Sir Allen McClay, Chairman of the Almac Group. All 300 staff at the Audubon site were invited and Almac staff from other US and European facilities travelled to Audubon for the celebrations. Since its opening in the US, Clinical Services has achieved significant growth in the American market.

“Our operations at Audubon have gone from strength to strength since their opening ten years ago. Clinical Services work with many of the leading pharmaceutical and biotech companies and have been involved in many of the largest clinical trials conducted worldwide. We currently distribute investigational clinical trial products to over 100 countries globally and this list is ever expanding.”

said Robert Dunlop, President & M.D., Almac Clinical Services.

Group Chairman, Sir Allen McClay, said:

“At Almac, we recognise that people are core to driving the company forward in terms of innovation and market share.  I would like to take this opportunity to congratulate all the people involved in driving our US efforts forward and look forward to further success in the future.”

Almac Clinical Services is one of the world’s leading providers of clinical trial material manufacturing, packaging and distribution services and employs 900 people in Europe and the US.

The post Almac Clinical Services Celebrates 10 Years in US appeared first on Almac.

The award, which recognises outstanding achievement and success through training and development, was presented at a gala ceremony last night in Belfast City Hall.

Faced with increased competition from US companies, the company needed to expand its range of services to retain its place in the market and improve its European trade base.

Almac Clinical Services offers a full range of services associated with the clinical trial process, including manufacturing, packaging, labelling and global distribution. Successful trials result in the licensing of superior new drugs which ultimately lead to improved healthcare solutions for patients. The company works with over 450 companies worldwide including all the market leaders in the pharmaceutical and biotech sectors.

In 2004 senior managers agreed a plan to reposition Almac Clinical Services as a premier supplier of value added services in Europe. Central to this was a Drug Supply Management, (DSM), plan made up of a number of key projects.

The strategy involved training over 300 employees and required an investment of £196,000.

Zoë Young, Almac Clinical Services Learning and Development Officer, explained the strategy:

“We wanted to achieve four main business goals including a new marketing strategy for DSM, a standard process capability across the group and to implement portal and people development.

“The resulting training programme was designed to include a broad spectrum of learning and development skills, ranging from communication and management to specific technical, business and IT application.

“The benefits have included a record turnover in the past 12 months. Almac Clinical Services gained 48 new customers in 2005 and a further 12 in 2006. In the past 12 months, one in three recruitments has been via internal promotion/transfer. This is a strong indication of the success of our investment and staff development through this training programme.”

Sir Allen McClay, Chairman of Almac, said: “I would like to take this opportunity to congratulate Zoë on her award, and thank her for her efforts on behalf of the entire Almac family. At Almac, the development of our staff is of prime importance, and this award recongises both Zoë’s efforts and our company’s commitment to its employees.”

If you are interested in attending an NTA information seminar in October, please log on to http://www.nationaltrainingawards.com for further details.

NOTES TO EDITORS:

1. 20 winners including employers, individuals, partnerships and training organisations received National Training Awards at a ceremony in Belfast City Hall on Tuesday 17 October 2006.

2. Almac Clinical Services is a division of the Almac Group comprising five closely integrated divisions offering a broad range of services from R&D, diagnostics, API manufacture, formulation development, through all phases of clinical trials to commercial scale drug product manufacture. Working with companies including all the world leaders in the pharmaceutical and biotech sectors, the five divisions are Almac Diagnostic Services, Almac Sciences, Almac Clinical Services, Almac Clinical Technologies and Almac Pharma Services. The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. In Europe, as well as Craigavon, operations are also located in London and Edinburgh.

3. Almac Clinical Services Ltd holds an Investor in People Award.

4. Photograph caption:

5. Media queries to the Department for Employment and Learning Press Office on 028 9025 7872.

clinicalservices@almacgroup.com

The post Almac Clinical Services Scoops National Training Award appeared first on Almac.

This adds to the already established high level of global capacity available dedicated to refrigerated clinical trial supplies. The unit consists of over 1500 shelved locations for storage and distribution of trial materials.

The clinical trial market has presented a huge increase in the requirements for dedicated cold chain facilities, particularly from the emergent Biotechnology sector. Temperature sensitive products require expertise in management of the complete supply chain, from shipper design, courier interactions and data monitoring to reduce overall risk to trial supplies.

Combined with Almac’s global depot network, cold–chain specialists and experience in cold-chain management , Almac now offers unrivalled cold chain resources for their client base.

About Almac Clinical Services

Almac Clinical Services is a globally integrated company focused on clinical trial supply solutions, with sites in Craigavon (UK), Audubon (PA, USA) and Durham (NC, USA). Almac Clinical Services enables clients to meet their trial start dates by leveraging skilled and experienced personnel coupled with robust quality systems and operational flexibility. Services provided include blinding, packaging, labelling, global distribution, QP release, analytical testing, drug supply management and online randomisation.

About Almac

Almac comprises five closely integrated divisions offering a broad range of services from R&D, diagnostics, API manufacture, formulation development, through all phases of clinical trials to commercial scale drug product manufacture. Working with companies including all the world leaders in the pharmaceutical and biotech sectors, the five divisions are Almac Sciences (formerly CSS), Almac Clinical Services (formerly CTS), Almac Clinical Technologies (formerly ICTI), Almac Pharma Services (formerly PDMS) and Almac Diagnostic Services. The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. In Europe, as well as Craigavon, operations are also located in London and Edinburgh.

The post Clinical Services Continues Expansion with New Refrigerated Facility appeared first on Almac.

Further agreements have been implemented in both China and India, two key emerging markets within the Clinical Trials Industry. These agreements are a further boost to the range and breadth of service available for the global distribution of clinical trial patient kits.

Logistics Manager Andrew Scott said:

“We are delighted to add these countries to our global depot network. This will enable us to offer our clients extensive coverage for any future clinical trials that may be performed in these regions. We have effectively responded to the market need to offer GMP compliant distribution services within these key clinical trial destinations, and have greatly improved our offering to prospective clients.”

These additions build on an existing depot network located across the world in including Russia, Ukraine, Argentina, Mexico, Brazil, Peru, Chile, Israel, France and Australia.

About Almac Clinical Services

Almac Clinical Services is a globally integrated company focused on clinical trial supply solutions, with sites in Craigavon (UK), Audubon (PA, USA) and Durham (NC, USA). Almac Clinical Services enables clients to meet their trial start dates by leveraging skilled and experienced personnel coupled with robust quality systems and operational flexibility. Services provided include blinding, packaging, labelling, global distribution, QP release, analytical testing, drug supply management and online randomisation.

About Almac

Almac comprises five closely integrated divisions offering a broad range of services from R&D, diagnostics, API manufacture, formulation development, through all phases of clinical trials to commercial scale drug product manufacture. Working with companies including all the world leaders in the pharmaceutical and biotech sectors, the five divisions are Almac Sciences (formerly CSS), Almac Clinical Services (formerly CTS), Almac Clinical Technologies (formerly ICTI), Almac Pharma Services (formerly PDMS) and Almac Diagnostic Services. The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. In Europe, as well as Craigavon, operations are also located in London and Edinburgh.

The post Clinical Services Expands Its Global Depot Network appeared first on Almac.

The award-winning program, “GMP Training: Clinical Trial Blinding – Is That What I Think It IS?” provides background and hands-on experience in the area of “Blinding” (or masking) of clinical trial products. This program presents information in an interactive format using employee groups made up of every department at CTS. It is divided into two sessions and facilitated by the training and quality departments at CTS.

Led by CTS Training Manager Jacqueline Tusman, instructional designers and trainers include:

Lisa Anderson, Trainer

Troy Suessmuth, QC Manager

Al Benedict, QC Supervisor

Chris Groff, QC Supervisor

Barry Kerr, QC Supervisor

Tina Starson, QC Supervisor

Other 2006 Trainer’s Choice Award recipients include:

Abbott Laboratories

ZLB Berhing

Bristol-Myers Squibb

About the Conference

The PDA Biennial Training Conference and accompanying training courses and exhibition aims to help pharmaceutical and biopharmaceutical companies ensure they have well-trained workforces to implement new technologies effectively and efficiently. Themed, “Training… A Winning Strategy,” this year’s conference featured 35 concurrent sessions covering five learning tracks with the goal of helping delegates develop actionable strategies for business success.

About PDA

Connecting People, Science and Regulationsm

The Parenteral Drug Association (PDA) is a nonprofit international organization and a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at www.pda.org.

About CTS

CTS is a globally positioned company focused on provision of solutions for clinical trial supplies. CTS enables client companies to meet their trial start dates by leveraging of experienced staff and flexibility with robust quality systems. Services provided by CTS include blinding, packaging, labelling, global distribution, QP release, analytical testing, drug supply management and online randomisation via the WEBEZTM system.

Almac Sciences and its affiliated companies (CSS (Chemical Synthesis Services), CTS (Clinical Trial Services), ICTI (Interactive Clinical Technologies Incorporated), PDMS (Pharmaceutical Development and Manufacturing Services) and Almac Diagnostic Services) provide a broad range of services across drug discovery, diagnostics, pharmaceutical research and development, manufacture of API, clinical trials and drug product manufacture. US operations are based in Pennsylvania, North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh.

The post CTS Awarded Best Classroom Training Manual at 2006 PDA Biennial Training Conference appeared first on Almac.

The issue of a letter of compliance followed a recent voluntary inspection of the CTS Durham site and quality systems by two representatives of the MHRA on January 26th and 27th. The inspection examined the US site in terms of reference against the published EU guidelines on Good Manufacturing Practice (GMP) and found that CTS Durham were compliant with these guidelines.

Reflecting the global nature of clinical trials, the letter of general compliance demonstrates the need to adhere to the principles of GMP and the importance of consistent quality procedures across all sites involved in packaging and distribution of clinical trial supplies. CTS Durham now joins CTS Audubon (PA) in formally demonstrating EU GMP compliance.

Commenting on the inspection, Dr Robert Dunlop (Senior VP, CTS) said: “This is a tremendous achievement for CTS Durham and I would like to congratulate all the CTS staff involved in achieving this recognition. For our clients, this is a further demonstration by CTS of its commitment to providing leading quality practices in support of their global clinical trial requirements.”

Mr Paul O’Connor (Global VP Quality, CTS) added “This is excellent news for CTS Durham and testament to the quality and skill of our staff. At CTS we recognise the global scope, relevance and impact of our sphere of work. This ‘extra mile’ of cross market compliance echoes our commitment to be a world leader on quality and on service – wherever we do business.”

About CTS

CTS is a globally positioned company focused on provision of solutions for clinical trial supplies. CTS enables client companies to meet their trial start dates by leveraging of experienced staff and flexibility with robust quality systems. Services provided by CTS include blinding, packaging, labelling, global distribution, QP release, analytical testing, drug supply management and online randomisation via the WEBEZTM system.

Almac Sciences and its affiliated companies (CSS (Chemical Synthesis Services), CTS (Clinical Trial Services), ICTI (Interactive Clinical Technologies Incorporated), PDMS (Pharmaceutical Development and Manufacturing Services) and Almac Diagnostic Services) provide a broad range of services across drug discovery, diagnostics, pharmaceutical research and development, manufacture of API, clinical trials and drug product manufacture. US operations are based in Pennsylvania, North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh.

Contact Information:

Jonathan Calderwood

CTS Global Marketing Manager

+44 28 38 363857

pr@cts-almac.com

www.cts-almac.com

The post CTS Durham Undergoes EU-GMP Inspection From MHRA appeared first on Almac.

The objectives of the workshops were to allow clients access to various different “experts” across all the inter-related functions involved with Global IMP distribution. Subjects covered included an overview of cold chain distribution, shipping of controlled materials, use of distribution depots, hazardous goods, the perspective from the Qualified Person and how best to leverage links with IVRS systems.

Each workshop lasted a full day and consisted of presentations on each subject area, question and answer sessions with work through examples/case studies. This enabled clients to learn from the experience from within CTS and also from their industry peers, therefore adding to each individual’s knowledge of IMP distribution and the various pitfalls within the process.

A total number of 151 delegates attended the workshops over the two-week duration and this represented 64 different Pharmaceutical and Biotechnology companies that have benefited from the knowledge sharing with CTS.

This has been a very successful and rewarding event for all those involved, for both organisers and participants, so congratulations to everyone that played a part in the success.

About CTS and Almac Sciences

CTS is a globally positioned company focused on provision of solutions for clinical trial supplies, with sites based in Craigavon (UK), Audubon (PA, USA) and Durham (NC). CTS enables client companies to meet their trial start dates by leveraging of experienced staff and flexibility with robust quality systems. Services provided by CTS include blinding, packaging, labelling, global distribution, QP release, analytical testing, drug supply management and online randomisation via the WEBEZ system.

Almac Sciences and its affiliated companies (CSS (Chemical Synthesis Services), CTS (Clinical Trial Services), ICTI (Interactive Clinical Technologies Incorporated), PDMS (Pharmaceutical Development and Manufacturing Services) and Almac Diagnostic Services) provide a broad range of services across drug discovery, diagnostics, pharmaceutical research and development, manufacture of API, clinical trials and drug product manufacture. US operations are based in Pennsylvania, North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh.

Contact Information:

Jonathan Calderwood

CTS Global Marketing Manager

+44 28 38 363857

jonathan.calderwood@cts-almac.com

www.cts-almac.com

The post CTS Host Successful Global Clinical Trial Distribution Workshops In The US appeared first on Almac.

With the ever-changing clinical landscape CTS has assembled a group of key personnel from across all three sites, to present a series of single day, FREE, non-proprietary workshop on various aspects of global clinical trial distribution.

The post CTS Announce Agenda for Clinical Trial Distribution Workshops appeared first on Almac.