Accelerating the Pace of Progress for Innovative Biologic Products

  • Highlight the importance of manufacturing technologies for innovative biologic products
  • Discuss efforts to expedite development of products for small populations through increased use of accelerated approval
  • Review efforts toward global regulatory convergence
  • Summarize internal changes and external initiatives at FDA in support of expeditious product development

Peter Marks
Director – Center for Biologics Evaluation and Research (CBER)

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training 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 the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.