SECTION 2

Effective regulatory strategies

Regulatory agencies worldwide are facing a sharp increase in complex cell and gene therapy product applications, making it harder for them to give companies timely advice and guidance. In this section, Parexel experts and former regulators share how greater self-reliance and thorough preparation can help companies avoid delays and setbacks.

Download the executive summary of the full report

Article

Self-reliant developers can help over-stretched regulators expedite reviews

7 min

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Article

Five regulatory pitfalls for cell and gene therapies in the US, EU, and China, and how to avoid them

10 min

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Article

How to navigate a cell or gene therapy through China’s two-tier regulatory system

5 min

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Article

Planning phase-appropriate compliance for cell and gene therapies

8 min

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Article

FDA approvals data

8 min

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Contributing Experts

Christiane Niederlander

VP, Technical - Regulatory Strategy

Mingping Zhang （张明平）

Vice President, Technical - Regulatory Strategy

Pengfei Song, Ph.D.

VP, Regulatory Strategy

Rajiv Gangurde, Ph.D.

VP, Technical Operations, Cell and Gene Therapy

Siegfried Schmitt

Vice President, Technical PC

Sinan Sirac, MD, Ph.D., MSc

VP, Technical - Regulatory Strategy

Steve Winitsky

VP, Technical - Regulatory Strategy

Contributing Experts

Christiane Niederlander

VP, Technical - Regulatory Strategy

Mingping Zhang （张明平）

Vice President, Technical - Regulatory Strategy

Pengfei Song, Ph.D.

VP, Regulatory Strategy

Rajiv Gangurde, Ph.D.

VP, Technical Operations, Cell and Gene Therapy

Siegfried Schmitt

Vice President, Technical PC

Sinan Sirac, MD, Ph.D., MSc

VP, Technical - Regulatory Strategy

Steve Winitsky

VP, Technical - Regulatory Strategy