Rachel E. Sherman, MD, MPH, FACP - Founder
Few consultants can say they helped build the FDA regulatory framework your drug must navigate. Dr. Rachel Sherman can. After nearly 30 years at FDA — culminating as Principal Deputy Commissioner of Food and Drugs — she established RSP in 2019 to put that insider expertise to work for clients.
“Progress in medical product development requires all constituencies at the table. That conviction has been the guiding principle of my career.”
Rachel E. Sherman, Rachel Sherman Partners, LLC
MD, Mount Sinai School of Medicine | MPH, Johns Hopkins University |
BA Mathematics, Washington University in St. Louis |
Fellow, American College of Physicians
What Sets Dr. Rachel Sherman Apart
Dr. Sherman didn't just work at FDA — she shaped it.
On the Front Lines of the AIDS Crisis
Both at FDA and in the clinic, Dr. Sherman dedicated herself to patients in dire need — combining compassion and science to pioneer the expedited pathways that accelerated HIV drug approval, ensuring patients received therapy in record time without compromising important safeguards.
A Career Defined by Pioneering Programs
Dr. Sherman has led many of FDA’s most consequential initiatives. She directed the Critical Path Initiative, pioneered the Sentinel Initiative’s use of real-world electronic health data, shaped the Breakthrough Therapy program, built FDA’s biosimilars program from the ground up, conceived and built the Clinical Trials Transformation Initiative, and pioneered the use of public-private partnerships at FDA.
Proven Executive. Every Scale. Every Challenge.
A seasoned executive, Dr. Sherman brings rare operational depth to every engagement. Her career has spanned everything from go-to-market strategies for nimble start-ups to tenure as Principal Deputy Commissioner at FDA, when she was responsible for several thousand employees and a budget exceeding $500M.
Received FDA's Distinguished Career Service Award — Twice
Dr. Sherman was recognized in both 2014 and 2019 for her exceptional dedication and impact at the agency.
SUPPORTING CLIENTS Since Day One at RSP
Dr. Sherman is an engaged and proactive advisor. She has served on multiple corporate boards and in advisory roles, including:
Aptinyx (neurologic disorders) · Sema4 / GeneDx (genomic intelligence) · Curexa Investors (pharmacy compounding policy) · Pike Therapeutics, Chief Clinical/Regulatory Advisor · TriNetX, Advisor on real-world evidence · Harvard Pilgrim Health Care Institute, Lecturer · Duke-Margolis Center for Health Policy, Senior Policy Fellow
Dr. Sherman remains an active voice in regulatory policy — publishing, speaking, and driving initiatives that shape the future of drug development. Much of her most impactful work happens behind the scenes, in the boardroom and at the negotiating table, where discretion is as highly valued as expertise.
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.
Today, Rachel Sherman Partners (RSP) is bringing that unmatched regulatory expertise directly to clients, many of whom are navigating complex challenges to medical product development while trying to navigate the evolving environment at FDA. Frequent areas of RSP focus have included study design and clinical testing; novel evidence sources, such as real-world data and real-word evidence; combination and biosimilar product development; proactive identification and resolution of potential premarket hurdles; and assistance with post-approval marketing, surveillance, and safety challenges.
Recent RSP successes include managing the resubmission and FDA approval of compounds to treat rare diseases, in the face of previous failures; analyzing the regulatory landscape of program areas to enhance client submissions; rapidly interpreting and applying regulatory advice, including resolution of contentious Complete Response Letters, resulting in successful resubmissions; preparing clients for possibly contentious FDA advisory meetings and smoothing interactions with FDA to achieve productive results; resolving clinical holds by rapidly addressing Agency concerns; carrying out due diligence for investments; and preparing organizations to leverage large government contracts.
+ 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 impactful publications list, see her CV here