Steve Winitsky MD

Vice President, Technical Regulatory & Access, KMI/PAREXEL Inc

Steve has over 11 years of former FDA experience as a Medical Officer, Team Leader, and Acting Branch Chief in the Office of Tissues and Advanced Therapies (OTAT, formerly known as OCTGT) in the Center for Biologics Evaluation and Research (CBER). Dr. Winitsky gained extensive experience with review and supervision of cell and gene therapy files — INTERACTs (previously known in OTAT/OCTGT as pre-preINDs), INDs, and BLAs; plasma protein files — INDs and BLAs; device files — 510(k)s, IDEs, PMAs; and combination biologic and device files. Dr. Winitsky served as the primary clinical reviewer for approximately 90% of the cardiovascular files regulated by OTAT/OCTGT, along with oversight of numerous files covering over 50 clinical indications (e.g., inborn errors of metabolism, infectious disease, solid organ transplant, orthopedics, endocrinology, immunology, rheumatology, in utero repair) as Team Leader and Branch Chief. He worked closely with the Center for Devices and Radiological Health (CDRH) in reviewing combination biologic and device files. During his time in OTAT/OCTGT, he was involved in Working Groups that were responsible for drafting and finalizing FDA and CBER Guidances and implementing PDUFA and 21st Century Cures initiatives. He also reviewed or supervised the review of numerous Fast Track, Regenerative Medicine Advanced Therapy (RMAT), and Breakthrough Designation request applications. Dr. Winitsky earned a B.A. in Chemistry from Columbia University in New York in 1992. He then went on to earn his M.D. from the University of Miami School of Medicine in Florida in 1996. He was an internal medicine resident at Emory University and completed his residency in the NHLBI/NIH Clinical Associate Program in 1999, continuing as a Clinical and Research Fellow in the NHLBI Cardiology Branch, Laboratory of Molecular Cardiology, Molecular Physiology Section. Dr. Winitsky has received several Recognition Awards from the Food and Drug Administration, the most recent being an FDA Outstanding Service Award and a CBER Director’s Distinguished Service Award.