Peter Marks

Peter Marks is a prominent American hematologist and oncologist recognized for his leadership role as the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). He took on this critical position in 2016, following his tenure as the deputy director, where he played an integral role in overseeing the FDA’s vaccine program, particularly significant during public health emergencies.

Marks has been instrumental in advancing regulatory science and ensuring the safety and efficacy of biologics, including vaccines and blood products. His work has contributed to the development and approval of numerous therapies that have had a substantial impact on patient care.

However, in March 2025, Peter Marks was removed from his role by the U.S. Secretary of Health and Human Services, Robert F. Kennedy, Jr., marking a significant shift in leadership within the FDA. Throughout his career, Marks has been a strong advocate for innovation in medical products and has worked tirelessly to balance public health needs with regulatory requirements. His contributions to the field continue to influence policy and practice in hematology and oncology, earning him recognition as a key figure in the advancement of biologics regulation in the United States.