WASHINGTON– 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.
