Demystifying Cell & Gene Therapy Trials – Critical areas you should know for incorporating current FDA perspectives

Sponsored By:

Mo Heidaran, PhD., Vice President, Technical, Regulatory & Access, Parexel International Steve Winitsky, MD, Vice President, Technical, Regulatory & Access, Parexel International

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The field of Cell and Gene Therapy (CGT) holds tremendous promise for providing transformative benefits for unmet clinical needs, but biological complexity poses many challenges throughout the lifecycle of CGT product development. Keeping up to date with the latest Health Authority (HA) perspectives and understanding the phase-specific HA requirements provides a roadmap for planning a CGT development program. This session will discuss the implications of current FDA regulatory thinking on key CMC (Chemistry, Manufacturing and Controls), Clinical, and Compliance issues for CGT programs.

In this webinar, experts will highlight:

  • Strategic considerations for CGT product development
    • Gain insight on HA considerations for specific safety concerns for CGT product and indication
    • Tailored in vitro and in vivo safety evaluation strategies
  • Solutions on key challenges in consistent manufacturing of Cell and Gene Therapy products at commercial scale
    • Collection of starting materials
    • Establishing manufacturing controls
    • Dealing with manufacturing changes during all stages of the product development lifecycle
  • Addressing cGMP compliance issues for manufacturing and clinical evaluation of CGT products from a US FDA regulatory perspective
    • Chain of custody and chain of identity for early phases
    • Vendor and material qualification
    • Considerations for working with CMOs
  • Early FDA engagement opportunities for CGT sponsors
    • The recent INTERACT early feedback program
    • Expedited development programs, including RMAT
    • Considerations for development of CGTs as COVID-19 therapeutics
  • Lessons Learned
    • Case study of CAR-T development highlighting key clinical considerations for CGTs

On Demand

About the Sponsors

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. Headquartered near Boston, Massachusetts and in Durham, North Carolina, and supporting clients in more than 100 countries, our almost 20,000 employees are united by one simple fact. We care. We’re not just the people with brains, we’re the people with heart.

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