Former FDA Reviewers Panel: Perspectives on Cell and Gene Therapy Development from Inside and Outside the FDA

The development of cell, gene therapy, and genome editing presents several challenges. While research in this area has been happening for decades, the FDA’s first approval of a gene therapy was only 5 years ago. As the field continues to evolve, regulatory agencies have faced groundbreaking technologies that sometimes move faster than the regulations. In addition, several innovations in the field are academic based and the translation from academia to biotech to bring these medicines to patients can face major hurdles. Our panel of former FDA and experts in the field of cell and gene therapy aim to present solutions to some of these major challenges. Their experience from the FDA and now from the perspective of the developers will provide insights and best practices on how to address these challenges. The target audience includes academic researchers, start-ups, biotech companies in early to mid-stage of development, regulators, and investors.