Thank you for your interest in our upcoming webinar series.
The speakers in this webinar series are experts in navigating market requirements and supporting client partners to successfully launch their innovative Orphan and Gene Therapy drug products globally. They have extensive practical experience in the areas of regulatory, quality, packaging design, serialisation and supply chain management, working with our client partners, they ensure launch milestones are met and market entry strategies are successful.
Meet the Experts
Director Business Development ,
Regulatory Affairs Lead,
Serialisation System Team Leader ,
Packaging Design Manager,
Head of Technical Support, Packaging ,
Client Services Manager,
Head of Supply Chain, EMEA, Novartis Gene Therapies ,
Cara Young, Director Business Development
PhD Pharmaceutical Sciences
Cara is responsible for partnering with pharmaceutical and biotech businesses that are seeking specialized outsourcing strategies. Before joining Almac, she worked in research and development for 15 years. She uses that technical experience today to recognize whether a client’s program is a good fit for Almac’s many drug product capabilities, which range from early clinical development through commercial manufacturing and packaging.
What she enjoys most about her role is seeing drug candidates successfully advance through clinical phases, then rapid launch to the market, and improve patients’ lives. Cara holds a PhD in Pharmaceutical Sciences from Temple University.
David McCoubrey, Regulatory Affairs Lead
Education: MPharm Pharmacy, Member of the Pharmaceutical Society of Northern Ireland
David has worked in the Scientific Affairs Department of Almac Group for over ten years. His experience encompasses development, pre-approval and post-approval regulatory activities. This includes the management of scientific advice meetings, compilation and submission of clinical trial applications, and the management, compilation and submission of new Marketing Authorisation applications for medicinal products in the EU. David also has experience with the maintenance of INDs and NDAs for US drug products. He has prepared, submitted and maintained EU and US orphan designations, including managing pre-submission teleconferences with the European Medicines Agency and FDA.
After graduating from Queen’s University Belfast with a Masters degree in Pharmacy, David completed his training as a Pharmacist with Alliance Boots. He worked as a Pharmacist Manager for the company for three years before joining Almac.
Roisin Reilly, Serialisation System Team Leader
Education: Pharmaceutical Chemistry
Roisin has worked in serialisation at Almac for over 4 years as part of the Serialisation System Team at Almac. She has been responsible for the implementation of global serialisation projects, working with multi-disciplinary teams including QA, Packaging Design, Production, Logistics, IT and Client Services. Leading serialisation projects to introduce Almac serialisation solution for global markets, including US, EU and Russia.
During her time in the Serialisation Team she has led and developed a team of System Specialists and System Administrators ensuring Almac compliance in a constantly evolving and challenging area.
Stuart Hunter, Packaging Design Manager
Education: City & Guilds of London Diploma in Lithographic Printing; City and Guilds of London Diploma in Artwork & Design for Print
Joining Almac Group in February 2010 as Packaging Design Manager, Stuart has almost 20 years of pharmaceutical packaging and artwork experience in which he has assisted in the launch of various product globally. Stuart has significant experience working with regulatory affairs, supply chain and operation for the strategy and implementation of medicinal products in global markets including Europe, USA, Canada, Japan, Australia, New Zealand, Brazil and South Africa / other African markets.
While responsible for the packaging design, artwork creation and management of all printed commercial packaging components, Stuart also possesses extensive printing knowledge across all platforms and acts as the primary interface with print packaging suppliers to ensure components are printed and manufactured as per design specification.
Robert O’Brien, Head of Technical Support, Packaging
Education: BSc Chemistry; Diploma Packaging Development Technology
Robert has almost 20 years’ experience in managing commercial product launches in both pharmaceutical and FMCG industries. Over this period, he has led multi-disciplinary teams to support a number of challenging, but ultimately, successful, global product launches and transition into on-going commercial supply. Leading the Technical Support function within Almac Commercial Packaging, he and his team are responsible for end-to-end operational launch. From product & process design, through validation requirements to timely commercial production and launch.
After graduating from University of Liverpool, Robert spent the majority of his career in the soft drink industry working for both Coca-Cola and Britvic plc on national and international developments and product launches, before transferring to pharmaceuticals.
Emma Jordan, Logistics Manager
Education: BSc Economics with Finance
Emma is responsible for the Logistics Department within Almac Pharma Services; encompassing the distribution, warehousing and procurements functions of the business. The Logistics department is responsible for managing the despatch of temperature controlled material throughout Great Britain, Europe and Rest of World, as well as supporting procurement activities on a global scale.
Emma has gained significant experience in supporting Clients to navigate the regulatory and customs landscape to develop supply chains bespoke to their product needs.
Emma joined Almac Pharma Services after graduating from Queens University Belfast and has held different roles within the Logistics Department of the company. She has gained significant experience in several fields within Logistics and has led numerous projects within the business including the addition of a new cold chain facility and is listed as Responsible Person on the Almac Pharma Services Wholesale Distribution Authorisation (WDA).
Gregory Lee, Client Services Manager
Education: BSc Pharmacy
Greg is responsible for all US New Production Introductions and Commercial Packaging projects at Almac Pharma Services. His team comprises of Product Supply Managers and Project Coordinators, each dedicated to all types of primary and secondary packaging, labelling, and serialization projects. Based on Successful Project Management principles, the Client Services Team customizes each Project Plan to provide personalized, flexible, quality led commercial solutions from orphan drug launches to ongoing high volume commercial product packaging and supply.
After graduating from University of the Sciences in Philadelphia with his Pharmacy degree, Greg has spent his 20+ year career on all facets of a drug life cycle as a Project Manager:
- Phase II-III Clinical Trials, eCOA/ePRO/eClinical Outcome Assessments, End-Point Data Reliability, Rater Training, Trial Efficiency, and RTSM
- Commercial Drug/Device Manufacture and Packaging
- In-patient Hospital and Retail Pharmacy
- Clinical Pharmacology and Drug Information
- Post-approval Formulary and Protocol Management, REMS, SFA/CRM, Patient Access
- Hospital and IDN Contracting and Reimbursement/Loss of Exclusivity Management
Ian Mussen, Head of Supply Chain, EMEA, Novartis Gene Therapies
Ian has over 20 years’ experience in global supply chain operations with the last 13 in Biotech, predominantly establishing and building manufacturing and supply operations, leading to subsequent product and market launches.