Job title: Director, CBER
Peter Marks, M.D., Ph.D. is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. The center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies. Dr. Marks and center staff are committed to facilitating the development of biological products and providing oversight throughout the product life cycle. Examples of these activities include:
- reviewing and providing advice during product development
- evaluating applications and making approval decisions based on safety and effectiveness data
- monitoring the safety of biological products
- conducting research that supports product development and characterization
“The center regulates and does research on complex biologic products that touch people’s lives on a daily basis,” says Dr. Marks. “Many of the products that we regulate are vital for promoting and protecting the public health, including vaccines, blood products, and tissues for transplantation. I’m very proud to lead a team of highly committed individuals whose efforts help to ensure the timely development of safe and effective products to meet important medical needs.”
Dr. Peter Marks 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, 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 on the clinical development of hematology and oncology products prior to returning to academic medicine at Yale University where he led the Adult Leukemia Service and 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 2016. Dr. Marks is board certified in internal medicine, hematology and medical oncology, and is a Fellow of the American College of Physicians.
Panel Discussion: Evaluating the Analytical Strategies of the Leading Companies in the Field 11:45 am
This interactive panel discussion will bring together the leading companies in the field to discuss key takeaways from pioneering gene therapy programs. Topics to be covered include: Investigating common analytical challenges encountered across various programs in different indications and with different specifications Balancing the complexities of analytical requirements with the drive to progress therapeutics to…Read more
day: Day One
FDA Perspective on Analytical Regulatory Expectations 8:30 am
Provide insight in to the type of analytical data required to support agency licensure Present case studies reflective of specific requirements reflective of recent regulatory experience Share the need for adaptation to the specific and unique nature of the gene therapy program – how do expectations differ between indications and scales of manufacturing Review the…Read more
day: Day One