Dr. Kerry Jo Lee is the Associate Director for Rare Diseases in the Division of Rare Diseases and Medical Genetics, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER). In this role she leads the Rare Diseases Team, a multidisciplinary rare disease programming and policy team that works to promote their mission to facilitate, support, and accelerate the development of drugs and therapeutic biologics for rare diseases. The RDT also serves as the program management office for CDER’s ARC Program. Dr. Lee joined the FDA as a medical officer in 2014 with the former Division of Gastroenterology and Inborn Errors Products, OND, CDER. Dr. Lee then moved to a position as a clinical advisor for the Office of New Drug Policy, CDER, where she served as a lead in the areas of benefit-risk assessment, modernization efforts (including the integrated review for marketing applications), and real-world data/evidence programming before serving in her current position.
Dr. Lee is a pediatric gastroenterologist/hepatologist. She is a graduate of Princeton University and the New York University School of Medicine with an honors degree conferred in microbiology. She completed her residency in pediatrics at the Children’s Hospital of Los Angeles followed by a post-doctoral clinical fellowship in Pediatric Gastroenterology, Hepatology, and Nutrition at Columbia University College of Physicians and Surgeons in New York.