Kerry Jo Lee

Associate Director for Rare Diseases at Office of New Drugs | Center for Drug Evaluation and Research | FDA

Speaker

Dr. Kerry Jo Lee is the Associate Director for Rare Diseases in the Division of Rare Diseases and Medical Genetics, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs (OND), CDER. In this role she leads the Rare Diseases Team, a multidisciplinary rare disease programming and policy team that works across CDER to promote their mission to facilitate, support, and accelerate the development of drugs and therapeutic biologics for rare diseases. Dr. Lee also serves as Program Manager of CDER’s Accelerating Rare disease Cures Program. Dr. Lee is a pediatric gastroenterologist/hepatologist who joined the FDA as a medical officer in 2014. Through previous roles in CDER/OND, Dr. Lee has 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 in CDER drug review and policy.