feb 13, 2018: middag - 12:55 p.m.
Dr. Rachel Sherman is Principal Deputy Commissioner of the U.S. Food and Drug Administration (FDA). She oversees all FDA medical programs and initiatives that are agency cross cutting and clinical, scientific, regulatory, or operational. She also provides advice and counsel to the FDA Commissioner on medical product regulation and oversees on his behalf other high-priority agency initiatives and programs. Key focus areas include modernization of combination product review, orphan product development, the Oncology Center of Excellence, promoting the use of innovative trial designs, and standards for evidence development.
Dr. Sherman has served FDA since 1989 in a variety of capacities, beginning as a primary reviewer in FDA's Center for Drug Evaluation and Research (CDER) during the height of the AIDS crisis. In 2005, Dr. Sherman moved to FDA's Office of the Commissioner, where she served until 2009 as Associate Commissioner for Clinical Programs and directed the agency's Critical Path Initiative.
From 2009 to 2014, as CDER's Associate Center Director for Medical Policy and Director of CDER's Office of Medical Policy, Dr. Sherman led a large, multidisciplinary staff charged with developing and implementing high-priority policies and programs, including the Sentinel Initiative, FDA's program for regulating biosimilars, and the agency's expedited drug development and breakthrough therapy designation programs. She organized multi-stakeholder public private partnerships, oversaw development of regulations and guidance for industry, and played a key role in enhancing clinical trial quality and good clinical practice. 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 2014, after 25 years of dedicated service to FDA and public health, Dr. Sherman retired. In 2015, she was asked to return to lead the Office of Medical Products and Tobacco, focusing on cross-center initiatives that foster efficient medical product development and facilitate patient access to new therapeutic products, work she will continue in her role as FDA 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, Division of Infectious Diseases, at the 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 an adjunct assistant professor in the Division of Clinical Pharmacology in the Department of Medicine at Duke University.
Speaker: Rachel Sherman, MD, MPH, Principal Deputy Commissioner, U.S. Food and Drug Administration (FDA)
Moderator: James C. Greenwood, President and Chief Executive Officer, Biotechnology Innovation Organization (BIO)