Tom Finn, Ph.D. is a CMC reviewer in the Division of Cell and Gene Therapy within the Office of Tissues and Advanced Therapies at FDA/CBER. He joined the FDA in 2006 where he reviews regulatory submissions at all stages of product development, and performs pre-licensure and biannual facility inspections. Dr. Finn reviews a wide range of cellular therapies, including a variety of cancer immunotherapies, neural and cardiovascular stem-cell based products, and many regenerative medicine products. Dr. Finn has regulatory expertise in bioassays, product comparability, product stability, and process validation, and was part of the BLA review team for Provenge and Kymriah. He is involved in numerous CBER internal working groups, such as CBER’s CMC Coordinating Committee, and also serves on the FNIH Biomarker Consortium Neuroscience Steering Committee. He received his PhD in Cell Biology from Oregon Health & Science University, conducted neuroimmunology postdoctoral work at the Portland VA Medical Center, and then continued his research interests as a Research Assistant Professor in the Department of Neuroscience at Georgetown University.
He has given numerous talks on a variety of regulatory challenges for cell and gene therapies, including for PDA, Well Characterized Biologics, Phacilitate, ISCCR, ISCT, and major academic centers.