Peter Marks, MD, PhD
Former Director, FDA Center for Biologics Evaluation and Research
Dr. Peter Marks is a hematologist-oncologist who served as Director of the FDA’s Center for Biologics Evaluation and Research, where he led the Center through the COVID-19 vaccine response and the modern era of cell, gene, and tissue therapy regulation. He was a co-architect of Operation Warp Speed and oversaw the regulatory framework for an unprecedented expansion of advanced biological therapeutics, including chimeric antigen receptor T-cell therapies, gene therapies for rare and ultra-rare diseases, and the first wave of mRNA-based products. His perspective bridges academic hematology, translational research, and the most consequential biologics regulatory decisions of the past decade.