Speaker Profile

M.D., Ph.D., Director, Center for Biologics Evaluation and Research, FDA

Biography
Peter Marks received his graduate and medical degrees from New York University. Following this, he completed an Internal Medicine residency and Hematology/Medical Oncology fellowship at Brigham and Women’s Hospital in Boston, where he subsequently joined the attending staff as a clinician-scientist and eventually served as Clinical Director of Hematology. He then moved on to work for several years in the pharmaceutical industry prior to returning to academic medicine at Yale University where he served as Chief Clinical Officer of Smilow Cancer Hospital. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016. Dr. Marks and center staff are committed to facilitating the development of biological products and providing oversight throughout the product life cycle.

Talk
Immuno-Oncology Products At CBER
The Center for Biologics Evaluation and Research (CBER) regulates complex biologic products including genetically modified T cells (e.g., CAR-T cells), therapeutic cancer vaccines, and microbiome products. All of these are increasingly being used in the treatment of cancer. CBER aims to take a risk-based approach to ensuring that safe and effective IO products are available as quickly as possible to benefit cancer patients in need.


 Session Abstract – PMWC Silicon Valley


Recent articles questioned the validity of the current FDA programs for rapid cancer drugs approval, suggesting they may be flawed. This panel will review the FDA Accelerated Approval, Breakthrough Therapy, Fast Track, and Priority Review programs, why the programs were created, how they address the needs and wishes of patients and families, and some of the points that the authors failed taking into consideration.