Winitsky has more than 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) in the Center for Biologics Evaluation and Research (CBER). He has extensive experience with review and supervision of cell and gene therapy files ̶ INTERACTs (previously known in OTAT/OCTGT as pre-preINDs), INDs, and BLAs. Steve has also been a clinical reviewer for approximately 90% of the cardiovascular files regulated by OTAT/OCTGT, along with oversight of numerous files covering over 50 clinical indications. He has also reviewed or supervised the review of numerous Fast Track, Regenerative Medicine Advanced Therapy (RMAT), and Breakthrough Designation request applications.
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