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Cell Therapies Branch, Division of Cellular and Gene Therapies, OTAT, CBER, FDA
Presently, Dr. Fink is engaged in overseeing an extensive portfolio of applications that includes hematopoietic, mesenchymal, cord blood, placenta-derived, and pluripotent stem cell-derived cellular products. His current appointment is as Expert Regulatory Biologist with specific...
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Founding Director, Interdisciplinary Stem Cell Institute; Professor of Medicine, University of Miami
Dr. Joshua Hare directs the Interdisciplinary Stem Cell Institute at the University of Miami. He is a pioneer advancing stem cell therapeutics through first-in-human clinical trials. He's published multiple clinical trials investigating mesenchymal stem cells in patients with heart...
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President of Research and Technology, Regenerative Patch Technologies
Jane Lebkowski has been actively involved in the development of cell and gene therapies since 1986 and is President of R&D at Regenerative Patch Technologies, a biotechnology firm developing composite stem cell-based implants for geographic atrophy. Jane Lebkowski also served as Chief...
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Director, Center for Biologics Evaluation and Research, 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...
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Vice President of Regenerative Medicine and Head of Neuroscience Programs, Athersys, Inc.
Dr. Mays is the Head of Neuroscience and VP of Regenerative Medicine at Athersys, Inc. He is focused on the company's proprietary stem cell product, MultiStem®, and its applications in Regenerative Medicine. Dr. Mays was the Principal Investigator of the published MASTERS clinical...
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Vice President of Regenerative Medicine and Head of Neuroscience Programs, Athersys, Inc.
Dr. Mays is the Head of Neuroscience and VP of Regenerative Medicine at Athersys, Inc. He is focused on the company's proprietary stem cell product, MultiStem®, and its applications in Regenerative Medicine. Dr. Mays was the Principal Investigator of the published MASTERS clinical...
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Industry Stakeholder Liaison, Corporate Stakeholders Department, European Medicines Agency (EMA)
Marie-Helene Pinheiro currently the Industry Stakeholder Liaison within the Corporate Stakeholders Department, at the European Medicines Agency. She is responsible for coordinating the Agency’s interaction with industry stakeholder organisations, for human and veterinary medicines...
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Director/DCEPT, Office of Tissues and Advanced Therapies, CBER, FDA
Dr. Purohit-Sheth is the Director for the Division of Clinical Evaluation and Pharmacology Toxicology (DCEPT) in CBER’s Office of Tissues and Advanced Therapies. Her division is responsible for oversight of clinical, pharmacology/toxicology, and clinical pharmacology reviews for...
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Branch Chief of Pharmacology and Toxicology 2, OTAT, CBER, FDA
Iwen Wu is currently Branch Chief of Pharmacology/Toxicology Branch 2 in the Office of Tissues and Advanced Therapies at CBER where she was previously a Pharmacology/Toxicology Team Lead and Reviewer. Prior to joining CBER, she was a lead reviewer in the Renal Devices Branch at the...
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