- Review the current state of gene therapy
- Discuss overcoming barriers to product development
- Make the case for global regulatory convergence
- Describe FDA actions facilitating gene therapy development
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Peter Marks
Director – Center for Biologics Evaluation and Research (CBER)
FDA
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.