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. He is a Fellow of the American College of Physicians and in 2022 he was elected to the National Academy of Medicine.

Dr. Atouf has over 20 years’ experience in research, product development, characterization and quality assessment of biologics including cell and gene therapies (CGT). At USP, he heads the Biologics program and oversees standards development, stakeholder engagement and external collaboration, to support the quality and safety of biological medicines. Dr. Atouf implemented new engagement models and collaboration approaches with academia, biopharma industry, and global government agencies. He has strong background in the regulation and standardization of pharmaceutical products including biologics and advanced therapies. He holds a Ph.D. in Cell Biology from the Pierre & Marie Curie University, Paris, France.

Dr. Verdun joined FDA in 2012, first in the Office of Hematology Oncology Products as a medical officer and a liaison for sickle cell therapeutics and anticoagulants, and then Therapeutic Biosimilars. She was appointed as the Deputy Director of the Office of Blood Research and Review in the Center for Biologics Evaluation and Research (CBER) in October 2016 and was promoted to Office Director in 2018. In 2023, Dr. Verdun was selected as the Super Office Director of the Office of Therapeutic Products, overseeing 6 Offices dedicated to the regulation and approval of Cell and Gene therapies in the United States. She overseas both a research and regulatory portfolio in CBER. She is also on staff at Children’s National Medical Center.

Dr. Nikiforow is currently an Assistant Professor at Harvard Medical School with the Stem Cell Transplant Program at Dana-Farber Cancer Institute, Medical Director of the Cell Manipulation Core Facility (CMCF), and Technical Director of DFCI’s Immune Effector Cell Program. She earned her MD and a PhD in Immunobiology at Yale University. Through the CMCF and as Principal Investigator of Phase I and II clinical trials, she is working to bring cellular therapies such as chimeric antigen-receptor T cells, genetically-modified stem cells, and regulatory T-cell infusions into the clinic at Dana-Farber. Her active involvement with FACT, ASTCT, ISCT, and CIBMTR committees enables engagement in initiatives across the cell therapy field and globe.

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas. James received his undergraduate and graduate degrees from Duquesne University and received his Health Care Compliance Certificate from Seton Hall University Law School. He is a member of various regulatory and quality work groups including RAPS, OCRA and the ASQ Orange Empire Section.