Peter Marks | Director, Center For Biologics Evaluation And Research (CBER)
U.S. Food and Drug Administration

Peter Marks, Director, Center For Biologics Evaluation And Research (CBER), U.S. Food and Drug Administration

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.


Day 1: Wednesday 19th May 2021 - Cell Therapy @ 12:00

Keynote panel discussion: How to ensure clinical success

  • Perfecting the art of regulatory submissions from pre-IND to final registration
  • How can we avoid idiosyncratic clinical responses to ATMPs?
  • Renewed guidance: are regulatory agencies changing how they view these approvals?
  • Safety and clinical considerations:Robust, novel pre-clinical models and standardised assaysWhat in vitro tests and animal models can you use to minimise clinical risk?What can you really extrapolate from preclinical investigation to humans?How much should you expand cells? Is a high or low cell dose important?Pharmacogenetics, biodistribution, toxicology.
  • Justification for routes of administration: what do the regulators think about delivery methods?

Day 1: Wednesday 19th May 2021 - Cell Therapy @ 12:30

Roundtable with the regulators: Ensuring clinical success

  • How do we move ahead?
  • Why is it important?
  • What’s the case to be made?
  • Why is it important that we get there?
  • Are there things we can do?
  • Smaller vs larger patient populations

Day 3: Friday 21st May 2021 - Commercialisation, Pricing & Access @ 11:30

Keynote panel discussion: Tackling large-scale, commercial regulatory

·Regulatory harmonisation issues·Covering multiple regions·Aligning regulatory approvals·State of affairs: a lot of modernisation
last published: 10/May/21 08:45 GMT

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