WASHINGTON--(BUSINESS WIRE)--Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that Wilson Bryan, M.D., has joined as Executive Vice President, Drug and Biological Products. Wilson served as Director of the Office of Tissues and Advanced Therapies (OTAT) in the FDA’s Center for Biologics Evaluation and Research (CBER) from OTAT’s establishment in 2016 through February 2023, leading the FDA’s oversight of cell and gene therapies and other advanced technologies during a transformative period in their development and regulation. His experience enhances Greenleaf’s cell and gene therapy capabilities and brings added perspective to the firm’s strategic advising on drug, biologic, and medical device regulation more broadly. As a neurologist and neuromuscular specialist, Wilson deepens Greenleaf’s expertise in those fields as well.
Under Wilson’s leadership, OTAT was responsible for the regulation of gene therapies, cellular therapies, genetically-modified cells (e.g., chimeric antigen receptor T cells), tissue-engineered products, plasma protein therapeutics (e.g., immunoglobulins; coagulation factors), selected medical devices, and xenotransplantation, covering a full range of medical indications. Of the thousands of applications in the OTAT portfolio, approximately 50% were for the treatment of rare diseases. OTAT also developed processes and standards for the new Regenerative Medicine Advanced Therapy (RMAT) designation.
During his 19 years with the FDA, Wilson also served as Director of CBER’s Division of Clinical Evaluation and Pharmacology/Toxicology, Chief of the Clinical Evaluation Branch in CBER’s Office of Cellular, Tissue, and Gene Therapies (OCTGT), a clinical team leader for the Division of Neurology Products in the Center for Drug Evaluation and Research (CDER), and a medical officer in CBER.
Prior to his work at the FDA, Wilson was on the faculty of the Department of Neurology of the University of Texas Southwestern (UTSW) Medical School for 13 years. At UTSW, he served as a neuromuscular specialist and was an investigator for clinical trials in neuromuscular disorders, particularly amyotrophic lateral sclerosis (ALS), and in cerebrovascular disease. Wilson received his medical degree from the University of Chicago Pritzker School of Medicine.
Learn more about Wilson Bryan.
About Greenleaf Health
Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience. Wilson Bryan 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); Heather Rosecrans, former Director of CDRH’s 510(k) staff; 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; Mark Kramer, former Director of the Office of Combination Products; and Chris Leptak, M.D., Ph.D., former Acting Office Director of CDER’s Office of Drug Evaluation Science.
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 robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.
For more information on Greenleaf Health, visit greenleafhealth.com.