Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, M.D., has joined as Senior Vice President, Drug and Biological Products. Throughout her 18-year FDA service, Sarah held multiple leadership, review, and advisory positions within the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Her knowledge of the FDA review process and regulatory policy will enrich the strategic and scientific guidance that Greenleaf provides to clients.
As an infectious disease specialist, Sarah dedicated much of her career to CDER’s antivirals division, where she played a significant role in the approvals of important new antiviral products, including the first-in-class HIV treatment raltegravir (as primary reviewer), the first-in-class hepatitis C treatment sofosbuvir (as team leader), and the SARS-CoV-2 treatment Paxlovid (nirmatrelvir co-packaged with ritonavir), as well as in the emergency use authorizations for anti-SARS-CoV-2 monoclonal antibody and small molecule products. Sarah was also the division’s Associate Director of Bioinformatics for three years (2017-2020), providing subject matter expertise in medical science and drug regulatory review processes and leading a multidisciplinary team within CDER responsible for modernizing the FDA’s review of marketing applications.
Her FDA experience further included serving as Acting Deputy Division Director in the epidemiology division of CBER, where she oversaw postmarket surveillance and adverse biologic reactions, as well as serving on the clinical advisors team for the Office of New Drugs (OND) policy group, where she contributed to the development of the FDA’s new drug guidance and policy.
Sarah received her M.D. from Georgetown University Medical School and completed a residency in internal medicine and a fellowship in infectious diseases at Duke University.
Learn more about Sarah McGarry.
About Greenleaf Health
Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience. Sarah McGarry joins a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Patrick Ronan, former Chief of Staff for two FDA Commissioners; Daniel Schultz, M.D., former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Karen Midthun, M.D., former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); John Jenkins, M.D., former Director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Robert Meyer, M.D., former Director of CDER’s Office of Drug Evaluation II; Sandra Kweder, M.D., former Deputy Director of the FDA’s Europe Office and Liaison to the European Medicines Agency (EMA); Wilson Bryan, M.D., former Director of CBER’s Office of Tissues and Advanced Therapies; Chris Leptak, M.D., Ph.D., former Acting Office Director of CDER’s Office of Drug Evaluation Science; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; Cynthia Schnedar, Director of CDER’s Office of Compliance, 2014-2016; Donald Ashley, Director of CDER’s Office of Compliance, 2017-2022; Heather Rosecrans, former Director of CDRH’s 510(k) staff; Mark Kramer, former Director of the Office of Combination Products; Joseph Griffin, former Associate Director for Policy Development, CDER Office of Medical Policy; Kalah Auchincloss, former Deputy Chief of Staff for two FDA Commissioners; Stephen Mason, former Assistant Commissioner of Legislation; Kristen Grumet, former Field Investigator for medical devices and member of the FDA Design Control Inspection Strategy (DCIS) Team; Thomas Berry, former Director of Compliance, Office of Pharmaceutical Quality Operations IV; and Grace McNally, former division director, CDER Office of Pharmaceutical Quality Policy.
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s combination of subject matter expertise, strategic insight, and deep institutional knowledge of the Food and Drug Administration equips clients with reliable, objective advice throughout the complex process of bringing medical products to the U.S. market.