Regulatory Perspectives on Gene and Cell Therapy: Past Lessons, Current Challenges, Future Directions - 2022 World Medical Innovation Forum

Regulatory Perspectives on Gene and Cell Therapy: Past Lessons, Current Challenges, Future Directions

Regulatory Perspectives on Gene and Cell Therapy: Past Lessons, Current Challenges, Future Directions

Monday, May 2, 2022

3:40 PM – 4:05 PM America Ballroom View Here
Fireside

At the end of 2021, roughly 410 novel drugs had been approved in the past decade. On average, there were 40 approvals per year with over 150 of them being between 2018 and 2020. What has changed in the approval process and what is the vision of the future state? What will happen over the next 1–3 years? What does the new iteration of the Prescription Drug User Fees Act (PDUFA) need to do in this area and which fields show the greatest potential for innovation in CGT?

Moderator:
Luk Vandenberghe, PhD
  • Grousbeck Associate Professor in Gene Therapy, Mass General Brigham (on leave)
Panelist:
Peter Marks, MD, PhD
  • Director, Center for Biologics Evaluation and Research, FDA