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Steven R. Bauer PhD
Chief Regulatory Science Affairs Program Officer
Wake Forest Institute for Regenerative Medicine
Winston Salem
USA
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Steven R. Bauer, PhD, Chief Regulatory Science Affairs Program Officer. Dr. Bauer co-directs the Translational Core and participates as a regulatory science advisor in the Regenerative Medicine Hub at the Wake Forest Institute for Regenerative Medicine in Winston-Salem, NC. Before joining WFIRM, Dr. Bauer was Chief of the Cellular and Tissue Therapies Branch in the Division of Cellular and Gene Therapies, in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). Dr. Bauer has three decades of experience in regulatory science research, regulatory oversight, and policy development for regenerative medicine product development. Dr. Bauer was a member of FDA’s Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS). As the Chief of CTTB, Dr. Bauer supervised CBER scientific staff engaged in review of cell- and gene-based biological therapies, policy development in emerging areas of cellular therapies, and research relevant to their use in clinical trials. Dr. Bauer has extensive regulatory experience with review of hundreds of regulatory submissions from all phases of product development from IND to BLAs including many novel cell, gene and tissue engineering applications. Dr. Bauer also headed FDA’s multipotent stromal cell (MSC) research consortium that published over twenty papers illustrating challenges and improvement strategies for characterization of complex MSC-based cellular and tissue engineering products. Dr. Bauer received his Ph.D. in Biochemistry from the University of Maryland in 1986. From 1986 through 1991, Dr. Bauer was a scientific member of the Basel Institute for Immunology in Basel, Switzerland. His research interests include development of strategies to improve characterization of stem-cell based therapies and to enhance our understanding of how manufacturing of regenerative medicine products influences the biological properties of these complex and heterogenous products.