Evolution of Regulatory Policy For Cell/Gene Therapy

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 www.io360summit.com