US FDA goals and priorities for cell & gene therapy regulation

Peter Marks

Peter Marks is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. Dr Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University. Following this, he completed an Internal Medicine residency and Hematology/Medical Oncology fellowship at Brigham and Women’s Hospital in Boston, where he subsequently joined the attending staff as a clinician-scientist and eventually served as Clinical Director of Hematology. He then moved on to work for several years in the pharmaceutical industry on the clinical development of hematology and oncology products prior to returning to academic medicine at Yale University where he led the Adult Leukemia Service and served as Chief Clinical Officer of Smilow Cancer Hospital. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016. Dr Marks is board certified in internal medicine, hematology and medical oncology, and is a Fellow of the American College of Physicians.

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