Rachel Sherman

Dr. Rachel Sherman is the former Principal Deputy Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), where she oversaw medical programs and initiatives that are cross cutting and clinical, scientific, regulatory, or operational.  As the Commissioner’s most senior policy advisor, Dr. Sherman provided council on medical product development and regulatory issues and oversees on his behalf high-priority programs and offices, including the Office of Medical Products and Tobacco, Office of Operations, Office of the Chief Scientist, and the Oncology Center of Excellence.  Key areas of recent focus include modernizing the agency’s organizational structure, streamlining review of combination products, and developing policies around orphan product development, patient engagement, use of real world evidence, prescription drug promotion and patient information, use of innovative trial designs, and standards for evidence development.

Dr. Sherman served the FDA since 1989 in a variety of capacities.  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 FDA’s Critical Path Initiative.

Upon her return to CDER in 2009, Dr. Sherman served 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.  Dr. Sherman was instrumental in 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 use of multi-stakeholder public-private partnerships; oversaw development of regulations and numerous guidances for industry; and played a key role in enhancing clinical trial quality and human subject protection. Her achievements contributed directly to more effective prescription drug promotion and to the modernization of professional drug labeling, generic drug labeling, and medication information for patients.

In 2015, after a brief retirement, Dr. Sherman was asked to return 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, work she continued in her role as Principal Deputy Commissioner.

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.  Currently, Dr. Sherman is a Senior Policy Fellow at the Margolis Center for Health Policy, Duke University; a Clinical Lecturer in the Department of Population Health, Harvard Pilgrim Health Care Institute, Harvard Medical School, and a Fellow of the American College of Physicians.

ALL OF DR SHERMAN’S SESSIONS ARE HIGHLY CUSTOMIZED AND DETAILED SESSION DESCRIPTIONS FOLLOW INITIAL BRIEFING AND BACKGROUND RESEARCH AND CLIENT PREEVENT CONFERENCE CALL

• Inside the FDA
• Analytics Data Quality Issues
• Building Effective Organizations
• Women in the Workplace
• Working Effectively with Government Agencies