Dr. Steve Winitsky, MD

Dr. Steve Winitsky, MD
Vice President, Technical
Parexel International

Dr. Winitsky spent more than 11 years at the FDA as a medical officer, a team leader, and acting branch chief in the Center for Biologics Evaluation and Research’s Office of Tissues and Advanced Therapies, which has recently been renamed the Office of Therapeutic Products. He has extensive experience with the review and supervision of CGT applications, including sponsor requests for Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations.


Effective regulatory strategies for rare disease

August 11, 2023

In the rare disease issue of New Medicines, Novel Insights from Parexel, experts and former regulators share insights for developing effective regulatory strategies earlier.