The American Society of Hematology (ASH) recognized Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA), for his outstanding commitment to hematology in overseeing the approval of therapeutics that improve the quality of the lives of people with blood disorders.
Dr. Marks received the 2021 ASH Outstanding Service Award, an honor recognizing effective leadership behind the scenes in areas relevant to the mission of the Society, and his overall commitment to advancing public health. Dr. Marks has been an active ASH member for more than 25 years and has been instrumental in leading efforts at the FDA to respond to the COVID-19 pandemic.
Peter Marks, MD, PhD
Martin S. Tallman, MD
“ASH is pleased to honor Dr. Marks, under whose leadership the FDA has made incredible advancements in the field of hematology, including overseeing the approvals of innovative cellular and gene-based therapies and working to streamline the regulatory process to get innovative therapies to patients in need,” said ASH President Martin S. Tallman, MD, of Memorial Sloan Kettering Cancer Center. “Dr. Marks has a long history of engagement as a member of ASH and as a valued friend to the Society through his role at the FDA. His support and leadership have contributed to the success of joint ASH-FDA programs in recent years.”
Contributions to Hematology
Dr. Marks, a clinician-scientist who is Board-certified in internal medicine and hematology and medical oncology, joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016. In this role, he oversees the center’s work of assuring the safety and effectiveness of biologic products, including vaccines; allergenic products; blood and blood products; and cellular, tissue, and gene therapies.
Dr. Marks has made hematology a key priority during his tenure at FDA. He helped the Agency lead the implementation of the 21st Century Cures Act, in which CBER rolled out the Regenerative Medicine Advanced Therapy Designation program for reviewing cell therapies and tissue-engineering products. Dr. Marks was instrumental in the success of the 2018 FDA-ASH Sickle Cell Disease Clinical Endpoints Workshop and the 2021 Real-World Evidence Stakeholder Initiative, hosted by the ASH Research Collaborative and the Institute of Genomics Innovation, in collaboration with the FDA.