About me
In his current position as Vice President, Technical for Regulatory Consulting 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 cell and gene therapies. Prior to coming to Parexel, he served 11 years as a Medical Officer in OTAT/CBER (the FDA Office that regulates cell and gene therapies), where he transitioned from Primary Clinical Reviewer to Team Leader, and finally to Acting Clinical Branch Chief for General Medicine. During his FDA tenure, he reviewed or supervised review of INDs for a variety of classes of cell and gene therapies in over 50 clinical indications.
