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Evolution of Regulatory Policy For Cell/Gene Therapy

  • Broadcast in Science
Pharma Talk Radio

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In this podcast, first recorded at the 2021 IO360° Summit, Dr Peter Marks, Center for Biologics Evaluation and Research (CBER), FDA, moderated a panel on the evolution of regulatory policy for cell/gene therapy.

Discussion points include:

  • What are the greatest challenges to the expeditious development of cell and gene therapies at this time?
  • How does the existing regulatory framework mesh with the current state of development of cell and gene therapy products?
  • What adaptations or adjustments to the regulatory framework that might further advance manufacturing or clinical development of these products?
  • Are there scientific developments coming that will require further adaptation or adjustment to the regulatory framework?

Panelists include:
Jeff Allen, PhD, Friends of Cancer Research
Anne Chew, PhD, University of Pennsylvania
Alberto Santagostino, Lonza Pharma & Biotech

To learn more about the upcoming 2021 IO360° conference, please visit