Pharmaceutical Development of ATMPs

Alison Wilson

Alison is an independent regulatory affairs consultant. Previously regulatory affairs manager for Smith & Nephew Wound Management, she has over 25 years’ experience of regulatory affairs in medicinal products, human tissue products and medical devices. She is a nominated UK expert for ISO (International Standards Organisation) TC150/WG 11 – Tissue Engineered Medical Products and a member of BSI Technical Panel RGM/1 – Regenerative Medicine.

Alison is a Module Advisor for the TOPRA* MSc in Regulatory Affairs (Pharma) (Module 9 – Biotechnology) and was Module Advisor for the MSc in Medical Technology Regulatory Affairs (Module 6 – Combination Products and Other Technologies) from 2006-2012. She is a member of the Topic Selection Panel for the MHRA Medical Device Technology Forum. She was a member of the MHRA (then MDA) working group responsible for production of the Code of Practice for Production of Human-Derived Therapeutic Products, 2002, and is the technical author for the BSI publication PAS 93: Characterisation of human cells for clinical application, published August 2011.

CellData Services provides strategic regulatory and development advice for a range of UK, EU and US clients seeking to develop and commercialise advanced therapy medicinal products (ATMPs), regenerative medicine therapies and drug-device combination products in the EU. Alison has extensive expertise in guiding smaller companies and academic groups through the regulatory complexities of development of novel regenerative medicine products, in particular scientific advice procedures and first-in-man clinical trials, and in recognition of this has received the first TOPRA Futures Award for contribution to regulatory science in new technology areas.

Andrew Willis

An independent consultant with 32 years of experience with regulatory affairs and pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects.

His experience is wide ranging, allowing fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management.

• Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintain patient focus.
• Orphan drug registrations of vaccine products and synthetic molecules
• NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised submission)
• Support for NBE during clinical phases and CMC support for a Biosimilar, Biosimilar / Biologic CMC reviewer for major pharma. Biosimilar experience includes working on first EU biosimilar onwards.
• Oversight of Regulatory strategy for ATMP (Cancer vaccine) and CMC lead for Stem Cell treatment
• Training to major pharmaceutical companies for Chemistry and Pharmacy section of the dossier and Life Cycle Management. Additional lead training / presentations on Life Cycle Management for TOPRA.

Furthermore, his responsibilities have provided senior management oversight and direction in the following key areas: -

• Strategic management of ATMP products for Biotech start-up company
• Strategic Biosimilar team, developing a global biotech and biosimilar strategy for key biosimilar products.
• Global Quality Leadership Team, providing oversight and direction for global quality processes.
• Innovation Team, providing oversight and direction for the innovation.

Additional experiences reflect raising funds for new start-up companies and associated due diligence activities. Also he has substantial awareness of management of P & L performance, growth initiatives related to service expansion, geographical expansion and innovative business development approaches.