Peter Marks

Company: FDA

Job title: Director

Bio:

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 FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016.  Dr. Marks is board certified in internal medicine, hematology and medical oncology, and is a Fellow of the American College of Physicians.

Seminars:

Fireside Chat: So You Have an Accelerated Approval: What Now? 9:30 am

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 FDARead more

day: Day One AM

Establishing a Robust Framework to Accommodate for the Increased Number of Clinical Stage Products 9:00 am

Benchmarking progress made with Operation Warp Speed for Rare Diseases Accelerated approval: clarifying its use for gene therapies and advice for programs submitting for it Outlining the key ‘call to actions’ needed for the rare gene therapy field to advanceRead more

day: Day One AM