Dr. Rosa Sherafat is a board-certified pediatric endocrinologist and the branch chief for General Medicine Branch 2, in the Super-Office of Therapeutic Products (OTP), in the FDA Center for Biologics Evaluation and Research (CBER). She received her medical degree from Tehran University of Medical Sciences, completed residency in pediatrics at University of Illinois Medical Center, Chicago, IL and fellowship in pediatric endocrinology in Cincinnati Children’s Hospital, Cincinnati, OH. She has been an associate professor of pediatrics in the Department of Pediatrics, Medstar Georgetown University Hospital, Washington, DC (2007-2018).
Dr. Sherafat joined FDA CBER in 2018 and has served as a Clinical reviewer and Team Lead in General Medicine Branch 2 for several cellular, tissue, gene therapy products and medical devices for a variety of neurology, dermatology and pulmonary indications. Dr. Sherafat served as the clinical co-chair and FDA speaker at the 70th Meeting of the Cellular, Tissue, and Gene Therapies (CTGT) Advisory Committee Meeting on Toxicity Risks of AAV Vector-Based Gene Therapy Products (September 2-3, 2021). She participated in the revision of the FDA Guidance for Industry, Long Term Follow Up after Administration of Human Gene Therapy Products (January 2020) and has represented CBER in several public meetings and workshops.