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Hilary D. Marston

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Hilary D. Marston
Hilary D. Marston
Alma materYale College (BA)
University of Pennsylvania (MD)
Harvard University (MPH)[1]
Scientific career
FieldsPandemic preparedness, clinical trial innovation, regulatory policy, global health
InstitutionsFood and Drug Administration

Hilary D. Marston is the former Chief Medical Officer of the Food and Drug Administration.[1]

Career

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Marston worked for McKinsey & Company and at the Bill & Melinda Gates Foundation as a program officer and special assistant. She then studied medicine at the Perelman School of Medicine and completed her residency in internal medicine and Global Health Equity at Brigham and Women's Hospital and earned her M.P.H. at the Harvard T.H. Chan School of Public Health.[2] In 2013, Marston joined National Institute of Allergy and Infectious Diseases (NIAID), as a medical officer and policy advisor for global health and pandemic preparedness.[3]

In 2021, Marston joined the United States National Security Council as director for medical and biodefense preparedness. She then served as director for global COVID-19 response on the White House COVID-19 Response Team. In this role, she led the US government's work in global distribution of COVID-19 vaccines, including overseeing sharing from the domestic supply and large-scale vaccine purchases for international donation.[4]

In 2022, Marston joined the US Food and Drug Administration as Chief Medical Officer.[5] In this role she oversaw the Office of the Chief Medical Officer which guides efforts to ensure timely review of combination products, incentive programs to promote interventions for rare diseases, and dedicated labeling for pediatric patients. She provided executive leadership, coordination, and oversight of FDA cross-cutting clinical and public health emergency-related regulatory policy matters, and public health preparedness and response activities on behalf of the Commissioner.[1]

During her tenure, Marston helped shape FDA work on real-world data in collaboration with other health agencies,[6] honed ethics frameworks for modern research approaches,[7] and harmonized clinical research terminology.[8] Marston left the FDA in 2025.[9]

Selected works

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  • Warraich, HJ; Marston, HD; Califf, RM (8 February 2024). "Addressing the Challenge of Common Chronic Diseases - A View from the FDA". The New England Journal of Medicine. 390 (6): 490–492. doi:10.1056/NEJMp2313217. PMID 38314843.
  • Rivera, Donna R.; Cutler, Tracy L.; McShane, Lisa; Meeker-O’Connell, Ann; Marston, Hilary D.; Califf, Robert M.; Bertagnolli, Monica M.; Avilés-Santa, Larissa; Ayalew, Kassa; Bayha, Ryan; Chetta, Joshua; Concato, John; Culp, Michelle; Dodd, Lori; Facey, Natasha; Forshee, Richard; Freedman, Andrew; Friedman, Philipa; Golfinopoulos, Elisa; Grandinetti, Cheryl; Jarman-Miller, Hannah; Jorgenson, Lyric; Karesh, Alyson; Kline, Lydia; Kluetz, Paul G.; Kraus, Stefanie; Lee, Jennifer J.; Lerro, Catherine C.; Levenson, Mark; Li, Jie; Lu, Yun; Moore, Céline; Ordóñez, Anna E.; Potter, Gail; Prindiville, Sheila; Rosenberg, Yves; Sarosy, Gisele; Shapley, Stephanie; Smith, Emily R.; Talley, Anne; Tamburro, Robert; Viviano, Charles; Yongpravat, Charlie (17 June 2025). "Modernizing Research and Evidence Consensus Definitions: A Food and Drug Administration–National Institutes of Health Collaboration". JAMA Network Open. 8 (6): e2516674. doi:10.1001/jamanetworkopen.2025.16674. PMID 40526378.
  • Califf, Robert M.; Meeker-O’Connell, Ann; Targum, Shari; Marston, Hilary (20 May 2025). "Recent Updates to the Declaration of Helsinki: A View from the U.S. Food and Drug Administration". Therapeutic Innovation & Regulatory Science. doi:10.1007/s43441-024-00734-2. PMID 40392410.


References

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  1. ^ a b c "Hilary Marston". Food and Drug Administration. 24 November 2024. Archived from the original on January 4, 2023.
  2. ^ "Hilary Marston, M.D., M.P.H." (PDF). Retrieved 25 November 2024.
  3. ^ "Office of the Chief of Staff - Contacts". NIH: National Institute of Allergy and Infectious Diseases. Archived from the original on December 25, 2016. Retrieved 2021-01-28.Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ "2021 Alumni Awards announced". 12 August 2021. Retrieved 24 November 2024.
  5. ^ "FDA adds some fresh senior leadership with new chief scientist, chief medical officer". Endpoints News. Retrieved 3 March 2023.
  6. ^ Abbasi, Ali B.; Layden, Jennifer; Gordon, William; Gregurick, Susan; DeLew, Nancy; Grossman, Jordan; Bierman, Arlene S.; Monarez, Susan; Curtis, Lesley H.; Viall, Abigail H.; Rocca, Mitra; Rivera, Donna R.; Marston, Hilary; Mugge, Alexandra; Smith, Scott R.; Bent, Katherine; Macrae, James; Sheehy, Ann; Wegrzyn, Renee D.; Valdez, R. Burciaga; Johnson, Carole; Bush, Laina; Blum, Jonathan; Cohen, Mandy K.; Bertagnolli, Monica M.; Califf, Robert M.; Tripathi, Micky (25 March 2025). "A Unified Approach to Health Data Exchange: A Report From the US DHHS". JAMA. 333 (12): 1074. doi:10.1001/jama.2025.0068. PMC 11936714.
  7. ^ Califf, Robert M.; Meeker-O’Connell, Ann; Targum, Shari; Marston, Hilary (20 May 2025). "Recent Updates to the Declaration of Helsinki: A View from the U.S. Food and Drug Administration". Therapeutic Innovation & Regulatory Science. doi:10.1007/s43441-024-00734-2.
  8. ^ Rivera, Donna R.; Cutler, Tracy L.; McShane, Lisa; Meeker-O’Connell, Ann; Marston, Hilary D.; Califf, Robert M.; Bertagnolli, Monica M.; Avilés-Santa, Larissa; Ayalew, Kassa; Bayha, Ryan; Chetta, Joshua; Concato, John; Culp, Michelle; Dodd, Lori; Facey, Natasha; Forshee, Richard; Freedman, Andrew; Friedman, Philipa; Golfinopoulos, Elisa; Grandinetti, Cheryl; Jarman-Miller, Hannah; Jorgenson, Lyric; Karesh, Alyson; Kline, Lydia; Kluetz, Paul G.; Kraus, Stefanie; Lee, Jennifer J.; Lerro, Catherine C.; Levenson, Mark; Li, Jie; Lu, Yun; Moore, Céline; Ordóñez, Anna E.; Potter, Gail; Prindiville, Sheila; Rosenberg, Yves; Sarosy, Gisele; Shapley, Stephanie; Smith, Emily R.; Talley, Anne; Tamburro, Robert; Viviano, Charles; Yongpravat, Charlie (17 June 2025). "Modernizing Research and Evidence Consensus Definitions: A Food and Drug Administration–National Institutes of Health Collaboration". JAMA Network Open. 8 (6): e2516674. doi:10.1001/jamanetworkopen.2025.16674.
  9. ^ Masson, Gabrielle. "FDA's chief medical officer Hilary Marston is out amid mass layoffs". Fierce Biotech. Retrieved 2 April 2025.
Public Domain This article incorporates public domain material from websites or documents of the National Institutes of Health.
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