Dr. Chaohong Fan is a board-certified hematologist and oncologist and serves as a lead oncology medical officer at the U.S. FDA, with 19 years of experience at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Dr. Fan is responsible for supervising and conducting clinical reviews and implementing regulations for cell and gene therapies aimed at the prevention, diagnosis, and treatment of cancers within the Office of Therapeutics Products (OTP) at CBER. She also acted as the branch chief for the Malignant Hematology Branch. Dr. Fan served as the key clinical reviewer in the drug development and approval of CBER’s first cellular therapy, Provenge (sipuleucel-T), gene therapy, Imlygic (talimogene laherparepvec), CAR-T product, Kymriah (tisagenlecleucel), and Tumor Infiltrating Lymphocytes (TIL) product, Lifileucel ( Amtagvi) for patients with oncological diseases. OTP plays a crucial role in facilitating the development and approval of the most innovative gene and cellular cancer therapeutics with curative potential. Prior to joining the FDA, Dr. Fan was an associate researcher in gene mapping and cloning for neurogenetic disorders including Amyotrophic Lateral Sclerosis at Northwestern University, Chicago after earning a Ph.D in genetics at Umea University, Sweden, an M. Sc in Medical Genetics at Hunan Medical University, China, and a M.D. at Zunyi Medical University, China.
Oncology Branch, DCEO, OTP