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