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), CDER. In this role she leads CDER's Rare Diseases Team and serves as Program Manager for the Accelerating Rare disease Cures (ARC) Program. Dr. Lee joined the FDA as a medical officer in 2014 with the former the 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. Dr. Lee maintains a steadfast interest in international policy and bioethics and worked for several years at the former National Bioethics Advisory Commission on reports advising the executive branch on ethical and policy issues in both international and domestic clinical trials as well as interning at the World Health Organization.