The last few years have shown us that cell and gene therapies, now called Advanced Therapy Medicinal Products (ATMP), are not just academic exercises in innovation but life-changing and viable candidates for regulatory approval. PDA has worked for several years to advance these therapies through the development lifecycle with an ongoing series of workshops and conferences, development of the ATMP Interest Group, publication of PDA Technical Report No. 81: Cell-Based Therapy Control Strategy and presentation of the annual PDA Europe Conference on Advanced Therapy Medicinal Products. Given the importance of these products to patients worldwide and the need for holistic collaboration across both industry and global regulatory authorities, PDA established the ATMP Advisory Board. The Advisory Board, which reports to the PDA Board of Directors, is tasked with driving the strategy for stewardship of emerging ATMP science, guidance and regulation.
The ATMP Advisory Board will help the industry navigate the complexities surrounding this relatively new class of biologics. Because the space is so new, the industry is experiencing a highly dynamic regulatory environment with new guidance and regulations developed at a rapid pace. This is significant in that the technologies used in ATMP manufacturing often outpace the regulatory framework required to guide organizations toward approval. The ATMP Advisory Board is focused on these topics and will help facilitate consistency across the industry through collaboration with volunteers and engagement with worldwide regulatory agencies.
The charter developed for the ATMP Advisory Board focuses on three priorities:
- Those technical aspects of ATMP that PDA believes are needed
- New members, particularly early career professionals, not just because the board is new, but because the ATMP space is new and requires new ways of thinking and approaching challenges
- Near-term concentration in the areas of product development, control strategy and microbiological methods
To pursue these goals, the ATMP Advisory Board is looking for volunteers to provide leadership through this complex milieu of science, technology and regulation. If you are interested in becoming a member of the ATMP Advisory Board, please fill out the skills and experience survey so the advisory board can evaluate your qualifications. If you have an idea for a project that the ATMP Advisory Board and PDA should consider, please fill out a project proposal form.