BIO
Steve Winitsky, M.D.
Senior Vice President, Technical, Regulatory Consulting
Steve spent more than 11 years at the FDA as a former Medical Officer, Team Leader, and Acting Branch Chief in the Center for Biologics Evaluation and Research’s (CBER’s) Office of Tissues and Advanced Therapies, which has recently been renamed the Office of Therapeutic Products (OTP). He has extensive experience with the review and supervision of cell and gene therapy (CGT) applications, including sponsor requests for Breakthrough Therapy and Regenerative Medicine Advanced Therapy designation. He also supervised numerous Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) and pre-IND meetings for CGTs.
More By This Expert
CTB Blog
Decoding FDA's new ‘plausible mechanism framework’ guidance: what drug developers need to know
Blog
FDA's new ‘plausible mechanism pathway’: Transforming regulatory approval for personalized gene therapies
Blog
Accelerated approval: Navigating FDA’s recent guidance and confirmatory trial considerations
Webinar
FDA Rare Disease Innovation Hub: Enhancing Collaboration and Speed?
Blog
Gene therapy: are high costs and manufacturing complexities impeding progress?
Blog
Key implications for nonclinical development: FDA guidance on human gene therapy products incorporating human genome editing
Blog
Making cell and gene therapy more accessible in the treatment of solid tumors
Podcast
CAR-T boxed warnings: What comes next?
Blog
CAR-T product development: an assessment of FDA’s final guidance for industry
Article
Five regulatory pitfalls for cell and gene therapies in the US, EU, and China, and how to avoid them
Article
Five regulatory myths about cell and gene therapy (CGT) orphan drug development
Article
Self-reliant developers can help over-stretched regulators expedite reviews
Article
What to know about FDA INTERACT meetings
Article
The Evolving Cell and Gene Therapy (CGT) Sector in China
Blog
Criticality of Institutional Biosafety Committee for Clinical Studies of Cell and Gene Therapy Products
Blog
Former FDA expert provides valuable advice on INTERACT programs for CBER products
CTB Blog
Decoding FDA's new ‘plausible mechanism framework’ guidance: what drug developers need to know
Blog
FDA's new ‘plausible mechanism pathway’: Transforming regulatory approval for personalized gene therapies
Blog
Accelerated approval: Navigating FDA’s recent guidance and confirmatory trial considerations
Webinar
FDA Rare Disease Innovation Hub: Enhancing Collaboration and Speed?
Blog
Gene therapy: are high costs and manufacturing complexities impeding progress?
Blog
Key implications for nonclinical development: FDA guidance on human gene therapy products incorporating human genome editing
Blog
Making cell and gene therapy more accessible in the treatment of solid tumors
Podcast
CAR-T boxed warnings: What comes next?
Blog
CAR-T product development: an assessment of FDA’s final guidance for industry
Article
Five regulatory pitfalls for cell and gene therapies in the US, EU, and China, and how to avoid them
Article
Five regulatory myths about cell and gene therapy (CGT) orphan drug development
Article
Self-reliant developers can help over-stretched regulators expedite reviews
Article
What to know about FDA INTERACT meetings
Article
The Evolving Cell and Gene Therapy (CGT) Sector in China
Blog
Criticality of Institutional Biosafety Committee for Clinical Studies of Cell and Gene Therapy Products
Blog
Former FDA expert provides valuable advice on INTERACT programs for CBER products
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