May 19, 2014 12:12 PM Eastern Daylight Time
WASHINGTON--(BUSINESS WIRE)--Greenleaf Health LLC ("Greenleaf") today announced that Rachel Sherman, M.D., M.P.H., F.A.C.P., former senior official at the U.S. Food and Drug Administration ("FDA" or "agency"), has joined the firm as Principal, Drug and Biological Drug Products. Prior to joining Greenleaf, Sherman served as Director of the Center for Drug Evaluation and Research's ("CDER") Office of Medical Policy and Associate Center Director for Medical Policy. In her new role at Greenleaf, Sherman will continue her commitment to public health by providing strategic consulting services and working with clients to bring innovative medical products to patients.
During her FDA tenure, Sherman was a driving force for innovation, new programs and policy. Sherman was responsible for spearheading and implementing the Sentinel Initiative, the Critical Path Initiative, biosimilars policy and the new Breakthrough Therapy Designation.
As Director of CDER's Office of Medical Policy and Associate Center Director for Medical Policy Sherman was responsible for developing, coordinating, and implementing medical policy programs and strategic initiatives as well as establishing and chairing CDER's Medical Policy Counsel. This included overseeing the regulation of prescription drug promotion and advertising.
Sherman began her career with FDA in the Division of Antiviral Drug Products at CDER in 1989—first as a medical reviewer and then as a clinical team leader. In 1998, she was appointed Deputy Office Director for the Office of Drug Evaluation I. In 1999, she assumed the duties of Deputy Office Director for the newly established Office of Medical Policy in CDER.
Sherman is a board certified internist and infectious disease subspecialist. She received her B.A. in mathematics from Washington University in St. Louis, her M.D. from Mt. Sinai School of Medicine in New York City, and her M.P.H. from the Johns Hopkins School of Hygiene and Public Health.
Dr. Rachel Sherman joins several former FDA officials at Greenleaf Health LLC, including Patrick Ronan, former FDA Chief of Staff and currently president of Greenleaf; Dr. Daniel Schultz, former Director of the Center for Devices ("CDRH") and Radiological Health and currently Greenleaf's Principal for Medical Devices and Combination Products; Michael Chappell, former Associate Commissioner for Regulatory Affairs, and currently Greenleaf's Principal for Regulatory Compliance; Heather Rosecrans, former Director of CDRH's 510(k) staff and currently Senior Vice President for Medical Devices and Combination Products; Linda Carter, formerly Associate Director of CDER's Office of Evaluation I and currently Vice President of Drug and Biological Drugs; and Taryn Fritz Walpole, former FDA Deputy Chief of Staff, and currently Chief Operating Officer and Senior Vice President for Regulatory Affairs. This blend of experience makes Greenleaf a unique consulting firm within the FDA arena.
Greenleaf Health is a full service regulatory consulting firm that provides strategic guidance to companies regulated by the FDA and those developing innovative solutions to pressing public health challenges around the globe. For more information on Dr. Sherman and Greenleaf Health, please visit www.greenleafhealthllc.com
Contacts
Greenleaf Health LLC
Taryn Walpole 202-609-8996 x4