Regenerative Medicine: Regulatory, Enforcement, and Legal Challenges for Cell and Gene Therapies

Keynote Address | April 2, 2020

During the COVID-19 crisis, FDLI is dedicated to serving as an educational resource for our valued members. To keep you up to date on the latest in the food and drug law community, we are providing exclusive access to a recording of Dr. Marks’ keynote address from FDLI’s first-ever Regenerative Medicine Conference, held virtually on April 2, 2020.

Dr. Peter Marks is the Director of FDA’s Center for Biologics Evaluation and Research (CBER). He received his graduate degree in cell and molecular biology and his medical degree at New York University. Following this, he completed an Internal Medicine residency and Hematology/Medical Oncology fellowship at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.