Steve Winitsky

Dr. Steve Winitsky has 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, the cell and gene therapy office, now known as OTP) in the Center for Biologics Evaluation and Research (CBER). He performed primary or supervisory clinical review of INDs for a variety of cell and gene therapy (CGT) products, covering over 50 clinical indications (e.g., cardiovascular, inborn errors of metabolism, infectious disease, solid organ transplant, orthopedics, endocrinology, immunology, rheumatology). During his time in OTAT, 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. In his current position as Vice President, Technical for Regulatory Strategy at Parexel International, Dr. Winitsky is a member of the Cell and Gene Therapy Center of Excellence. He provides clinical regulatory support to clients for all phases of product development for CGTs, including: support for rare disease program applications such as ODD and RPDD; helping to prepare clients for FDA meetings, such as INTERACT (early engagement program for CBER-regulated products), RMAT Designation meetings, and Type A/B/C Meetings, including pre-IND, end-of-phase, and pre-BLA meetings; and participating in authoring or review of BLA clinical modules. He also provides clinical and regulatory thought leadership as an invited speaker and author.