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Peter Marks (physician)

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For the English businessman and CEO, see Peter Marks (businessman).
Peter Marks
Director of the Center for Biologics Evaluation and Research
In office
January 1, 2016 – April 5, 2025
PresidentBarack Obama
Donald Trump
Joe Biden
Donald Trump
Preceded byKaren Midthun
Succeeded byVinay Prasad
Personal details
EducationColumbia University (BS)
New York University (MD, PhD)
Scientific career
FieldsHematology, Oncology
InstitutionsBrigham and Women's Hospital
Yale University
Doctoral advisorFrederick R. Maxfield

Peter Marks is an American hematologist and oncologist who served as the director of the Center for Biologics Evaluation and Research within the Food and Drug Administration. He was appointed to the position in 2016 after previously serving as deputy director. Among other duties, Marks oversaw the FDA vaccine program.

In March 2025, the US Secretary of Health and Human Services, Robert F. Kennedy, Jr., decided to force Marks from his position.

Education

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Marks earned a Bachelor of Science degree from Columbia University, followed by a Doctor of Medicine and PhD in cell and molecular biology from New York University in the lab of Fredrick R. Maxfield. As an undergraduate, he volunteered at Mount Sinai St. Luke's in New York City, where he worked in the radioimmunoassay lab. He completed an internal medicine residency and oncology training at the Brigham and Women's Hospital.[1][2]

Career

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After completing his training, Marks worked at the Brigham and Women's Hospital as a clinician-scientist, and later served as Clinical Director of Hematology. He then worked in the pharmaceutical industry, where he worked on the development of hematology and oncology products. He later managed the Adult Leukemia Service at Yale University and served as the Chief Clinical Officer of the Yale New Haven Hospital Cancer Center. Marks joined the FDA'sCenter for Biologics Evaluation and Research as deputy director in 2012, and was promoted to director in 2016.[3][4]

In May 2020, he was selected to serve as a member of the White House Coronavirus Task Force,[5] although he left a few days later over concerns that his participation would represent a conflict with his position at FDA.[6] Marks also played a role in establishing Operation Warp Speed, a partnership between the federal government and various private companies to develop a COVID-19 vaccine, but left the project in May 2020 shortly after it was launched. Marks believed he would be more useful in his role as chief regulator of vaccines as the Director of FDA's Center for Biologics Evaluation and Research.[7][8][9]

In 2021, Marks served as a plenary speaker at the State of the National Hemophilia Foundation's Science Research Summit.[10] In 2024, Marks overruled FDA staff to approve gene pharmacotherapy Elevidys—intended to treat Duchenne muscular dystrophy—despite it failing in Phase III clinical trial.[11]

On March 28, 2025, US Secretary of Health and Human Services, Robert F. Kennedy, Jr., informed Marks that he should resign or be fired. Marks wrote a resignation letter that lamented Kennedy's attempts to erode trust in vaccines: “However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”[12][13]

Personal life

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Marks has two children and resides in Washington, D.C., with his wife.[14]

References

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  1. ^ admin (2019-02-01). "Pulling Back the Curtain: Peter Marks, MD, PhD". ASH Clinical News. Retrieved 2020-08-31.
  2. ^ "Peter Marks, MD, PhD - BIO Digital | BIO". www.bio.org. Retrieved 2020-08-31.[permanent dead link]
  3. ^ Commissioner, Office of the (2020-02-03). "Peter Marks | FDA". U.S. Food and Drug Administration. Archived from the original on September 12, 2019. Retrieved 2020-08-31.
  4. ^ "BIO 2019 - Profile - Peter Marks". bio2019.zerista.com. Retrieved 2020-08-31.
  5. ^ "New Members of the White House Coronavirus Task Force Announced". whitehouse.gov. Retrieved 2020-08-31 – via National Archives.
  6. ^ "White House coronavirus task force fades further as fear of second wave emerges". NBC News.
  7. ^ "FDA's vaccine head quits Operation Warp Speed days after joining". www.beckershospitalreview.com. Retrieved 2020-08-31.
  8. ^ McGinley, Laurie. "Meet the most important federal official you probably don't know — the man who holds the fate of the coronavirus vaccine in his hands". Washington Post. ISSN 0190-8286. Retrieved 2020-08-31.
  9. ^ Owermohle, Sarah. "FDA struggles to remain independent amid race for virus cure". POLITICO. Retrieved 2020-08-31.
  10. ^ "NHF State of the Science Research Summit". National Hemophilia Foundation. Retrieved 2021-08-05.
  11. ^ "Sarepta Gains as FDA Official Overrules Staff to Approve Therapy". Bloomberg. Retrieved 2024-06-29.
  12. ^ Jewett, Christina; Stolberg, Sheryl Gay; Weiland, Noah (29 March 2025). "Top F.D.A. Vaccine Official Resigns, Citing Kennedy's 'Misinformation and Lies'". New York Times. Retrieved 29 March 2025.
  13. ^ Diamond, Dan (29 March 2025). "RFK Jr. forces out Peter Marks, FDA's top vaccine scientist". The Washington Post. Retrieved 29 March 2025.
  14. ^ "Operation Warp Speed: Transforming Disease Prevention with Peter Marks, MD, PhD". National Foundation for Infectious Diseases. 1 November 2023. Retrieved 29 February 2024.
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