Fireside Chat: So You Have an Accelerated Approval: What Now?

Time: 9:30 am
day: Day One AM

Details:

• Outlining challenges in the post-market studies to provide confirmatory data of a clinical benefit
• Implications for drug developers if confirmatory trials are negative
• Exploring the challenge of these therapies being deemed “unproven” or “experimental” by private insurers
• Understanding how to operationalize and source data being requested by the FDA

Speakers:

Peter Marks Peter Marks, M.D., Ph.D. is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. He joined the Read more

Richard Colvin Richard Colvin, MD, PhD, has served as Chief Medical Officer of bluebird since March 2021. Prior to bluebird, Rich was an executive director in translational Read more