Founding Partner & President
Rachel E. Sherman, MD, MPH, FACP
Rachel is the President and Founding Partner of Rachel Sherman Partners, LLC. She established the company in 2019 after almost 30 years with the U.S. Food and Drug Drugs Administration, ultimately serving as Principal Deputy Commissioner of Food and Drugs. Working with a network of expert associates, Rachel has successfully addressed a wide variety of client challenges at all stages of product development, both nationally and internationally. She advises clients of all sizes, including pharmaceutical manufacturers, biotech companies working on gene therapy, investment firms, regulatory consultancies, and academia.
With a background as an internist with a subspecialty in infectious diseases, Rachel applies her expertise in regulatory science and medical product evaluation and approval to areas of focus including:
Key areas of focus include:
Study design, clinical testing, and expedited development
Data analysis and novel sources of evidence, including RWD and RWE
Postmarket surveillance and safety challenges
Emerging areas, including combination products, rare diseases, biosimilars, and cell and gene therapies
Communicating high-quality patient and provider information
Patient advocacy
An accomplished executive, Rachel has a proven track record of building high-performing, dynamic teams that quickly adapt to challenging, high-pressure work environments to advance project goals.
Rachel has served as a member of the Department of Population Health, Harvard Pilgrim Health Care Institute. She has also served on the boards of Aptinyx, a clinical-stage biopharmaceutical company focused on the discovery and development of transformative therapies for challenging neurologic disorders, and of Sema4 (now, GeneDx), a patient-centered health intelligence company.
In January 2023, Dr. Sherman joined the board of directors of Curexa Investors, LLC, where she advises on regulatory policy and organizational matters, including on pharmacy compounding.
For more information about Rachel’s expertise, visit the sections below:
+ Background
Dr. Sherman joined FDA in 1989 as a medical reviewer but soon took on more responsibilities. She was a driving force in HIV drug development in FDA's Center for Drug Evaluation and Research (CDER) during the height of the AIDS crisis. After 15 years of increasing responsibility in CDER, in 2005, Dr. Sherman moved to FDA's Office of the Commissioner, becoming Associate Commissioner for Clinical Programs and directing a variety of programs, including FDA’s Critical Path Initiative. Upon her return to CDER in 2009, Dr. Sherman served concurrently as CDER's Associate Center Director for Medical Policy and Director of the Office of Medical Policy, a large, multidisciplinary staff charged with developing and implementing high-priority policies and programs, including launching and advancing the Sentinel Initiative; FDA's program for regulating biosimilars; and the agency's expedited drug development and breakthrough therapy designation programs. She spearheaded the creation and use of multi-stakeholder public-private partnerships; oversaw development of regulations and guidances for industry focusing on clinical trial quality, advertising and promotion, human subject protection and communicating information about medical products—key elements to her career-long role advocating for patients and the health care providers who care for them.
In 2015, after a brief retirement, Dr. Sherman was asked to return to FDA to lead the Office of Medical Products and Tobacco, overseeing multiple cross-center initiatives aimed at fostering efficient medical product development and facilitating patient access to innovative medical products.
During her time as Principal Deputy Commissioner, Rachel was responsible for cross-cutting clinical policy programs and operations, with a budget of more than $500 million and some 2,000 employees. She held key organizational responsibilities, including establishing FDA’s Oncology Center of Excellence and leading the reorganization of the FDA Commissioner’s office. In both 2014 and 2019, Rachel received the FDA Distinguished Career Service Award in recognition of her dedicated service to the agency.
Dr. Sherman is an internist with a subspecialty in infectious diseases. She received her MPH from Johns Hopkins University, her MD from Mount Sinai School of Medicine, and her BA in Mathematics from Washington University in St. Louis. She has served over the years as attending physician in the Division of Infectious Diseases, Veterans Affairs Medical Center; Clinical Assistant Professor of Medicine (infectious diseases) at Georgetown University; and volunteer physician with Montgomery Mobile Health.
+ Certifications & Licensure
• Licensure, State of New York, 1983 – 1988, 2015 – Present
• American Board of Internal Medicine, Internal Medicine, 1986 – Present
• American Board of Internal Medicine, Infectious Disease, 1990 – 2000
• Licensure – State of Maryland, 2002
+ Education
• Johns Hopkins University, MPH, 1988 – 1989
• The Mount Sinai Hospital, Fellowship in Infectious Diseases, 1986 – 1988
• Montefiore Hospital and Medical Center, Internship and Residency, 1983 – 1986
• Mount Sinai School of Medicine, MD 1979 – 1983
• Washington Univ. in St. Louis, AB, Mathematics, 1975 – 1979
For more information, including Dr. Sherman’s substantial publications list, see her CV here