Peter Marks, MD, PhD is director of the FDA’s Center for Biologics Evaluation and Research (CBER). The Center is responsible for ensuring the safety and efficacy of biological products, including vaccines, allergy products, blood and blood products, and cell, tissue and gene therapies.
Dr. Marks and staff at the center work to facilitate the development of biological products and oversee the entire product life cycle. Examples of these activities are:
“The center manages and researches complex biological products that touch people’s lives every day,” said Dr. Fraction. “Many of the products we regulate are critical to advancing and protecting public health, including vaccines, blood products, and tissues used for transplantation. I am proud to lead a highly dedicated team whose efforts help ensure timely development of safe Effective products to address important medical needs.”
Dr. Peter Marks holds degrees in Cell and Molecular Biology and Medicine from New York University. He then completed his internal medicine residency training and hematology/medical oncology fellowship at Brigham and Women’s Hospital in Boston, before joining the treatment team as a clinician scientist and eventually as the clinical director of hematology.
He then worked in the pharmaceutical industry for several years in the clinical development of hematology and oncology products before returning to Yale to pursue an academic career in medicine, leading the Adult Leukemia Service and serving as Chief Clinical Officer at Smilow Cancer Hospital. He joined FDA in 2012 as CBER Deputy Center Director and became Center Director in 2016. Dr. Marks is a board-certified physician in Internal Medicine, Hematology, and Medical Oncology and a Fellow of the American College of Physicians. In 2022, he became a member of the National Academy of Medicine, one of the highest honors in health, science and medicine.