Thomas_Finn

Thomas Finn

CBER, FDA

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, from pre-pre-IND advice to post-licensure supplements, and performs pre-licensure and biannual facility inspections. Dr. Finn reviews a wide range of cellular therapies, such as cancer immunotherapies and regenerative medicine products, including neural and cardiovascular stem-cell based 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. He 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.


Appearances