Peter Marks

Peter Marks

Company: FDA

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: Investigating the Current Global Regulatory Landscape in Light of Recent Approvals 12:30 pm

Learning from previous approvals to shape standards for future approvals Emphasizing safe and responsible development of gene therapies Exploring impacts on regulation of increased numbers of gene therapies looking for approvalRead more

day: Track C - Day 1 am

Industry Leaders Panel: Delivering on the Promise of Gene Therapies 9:00 am

Gene therapies continue to redefine the treatment of rare diseases, but these conditions present many distinct development challenges. This panel discussion will bring together experts from leading organizations in this field to analyse how we can overcome these hurdles to realize the potential of gene therapies Navigating uncharted territory: sharing the decisions industry pioneers have…Read more

day: Day One

Keynote: FDA’s Efforts to Enhance Gene Therapy Regulatory Interactions 8:00 am

Sharing FDA considerations regarding product manufacturing, including process validation Understanding how regulatory oversight will need to adapt to keep pace with technical innovations in gene therapy manufacturing and development Introducing the CATT meeting – an additional early opportunity to engage with regulators around key issues encountered in the broader development of gene therapies Distinguishing how…Read more

day: Day One

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