Speaker Profile
M.D.,Ph.D., Director, CBER, FDA
Biography
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 HematologyMedical 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 2016.
Session Abstract – PMWC 2025 Silicon Valley
Track 1 - February 5 9.00 A.M.-4.30 P.M.
Track Co-Chairs:
Yael Weiss, Mahzi Tx
Morten Sogaard, Astellas Gene Therapies
- PMWC 2025 Award Ceremony
Pioneer Honoree: James M. Wilson, University of Pennsylvania
Luminary Honoree: Carolyn Bertozzi, Stanford
- Keynote: Bioorthogonal Chemistry, from Basic Science to Clinical Translation
- Carolyn Bertozzi, Stanford
- Keynote: The Promise of Genetic Medicines Unless You're Too Poor or Too Rare
- James M. Wilson, University of Pennsylvania
- Reimbursement for Genetic Medicines in Rare Diseases
Chair:
- Erin Satterwhite, Optum Specialty Pharmacy
- Next-Generation Delivery Systems for Gene Therapies (PANEL)
Chair: Morten Sogaard, Astellas
- Mathieu Nonnenmacher, Voyager Therapeutics
- Kevin Friedman, Kelonia Therapeutics
- Kunwoo Lee, GenEdit
- Haig Aghajanian, Capstan Therapeutics
- James M. Wilson, University of Pennsylvania
- Beyond the Genome: Harnessing Epigenetics in Rare Disease Treatment (PANEL)
Chair: Charles Gersbach, Duke
- Prashant Mali, UCSD
- Nadav Ahituv, UCSF
- Blythe Sather, Tune Therapeutics
- Fyodor D Urnov, Berkely University
- Navigating the Regulatory Landscape for Gene and Cell Therapies (PANEL)
Chair: Yael Weiss, Mahzi Tx
- Courtney Silverthorn, Bespoke Gene Therapy Consortium (BGTC)
- Peter Marks, FDA
- Ben Dewees, Kyverna Therapeutics
- AI-driven Improvements in Gene and Cell Therapy (PANEL)
Chair: Morten Sogaard, Astellas
- Francois Vigneault, Shape Therapeutics
- John Androsavich, Ginkgo Bioworks
- Yogev Debbi, mana.bio
