Wilson joined Greenleaf Health in 2023, following a 19-year career at the FDA that culminated in his leadership of the Office of Tissues and Advanced Therapies in the Center for Biologics Evaluation and Research (CBER). A neurologist and neuromuscular specialist, Wilson was a clinician and clinical researcher for over a decade prior to his work at the Agency.
Wilson began his regulatory career as a medical officer in CBER, where he served as primary reviewer for Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs). He subsequently served two years as a clinical team leader in the Division of Neurology Products within the Center for Drug Evaluation and Research (CDER), with a focus on neuromuscular disorders, bioterrorism, and sleep disorders. Wilson then worked for three years as a regulatory consultant with the Biologics Consulting Group.
Wilson returned to CBER in 2009 as Chief of the Clinical Evaluation Branch in the Office of Cellular, Tissue, and Gene Therapies (OCTGT), and was later promoted to Director of the Division of Clinical Evaluation and Pharmacology/Toxicology. In 2016, Wilson became Director of the newly formed Office of Tissues and Advanced Therapies (OTAT). 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. OTAT-regulated products covered a full range of medical indications, including oncology, hematology, neurology, cardiology, endocrinology (e.g., diabetes), pulmonary, nephrology, dermatology, and a variety of surgical 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. Wilson retired from the FDA when OTAT was reorganized into the Office of Therapeutic Products (OTP) in 2023. His work at Greenleaf is informed by the experience of overseeing the FDA’s regulation of cellular and gene therapies, along with other advanced technologies, during a transformative period in which the foundation was laid for today’s development and approval processes.
Before joining the FDA in 2000, 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 bachelor’s degree from the University of South Carolina and his medical degree from the University of Chicago Pritzker School of Medicine. He completed an internal medicine internship at Grady Memorial / Emory University Hospitals, a neurology residency at Parkland Memorial Hospital / University of Texas Southwestern Medical School, and a neuromuscular / neurophysiology fellowship at Tufts University / New England Medical Center.