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Kimberly Benton, PhD

Master Principal
Dark Horse Consulting Group

Dr Kimberly Benton is a Master Principal at Dark Horse Consulting Group, where she provides extensive regulatory expertise and perspective to a broad range of clients in the cell and gene therapy field. Prior to joining DHC, she served for over 22 year at the US Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). Most recently, she served for as Associate Director for Regulatory Management in the Office of Tissues and Advanced Therapies (now known as the Office of Therapeutic Products). In this role, she directed the regulatory review program for the broad portfolio of products under OTAT’s purview: human tissues, cellular therapies, gene therapies, therapeutic vaccines, xenotransplantation products, and purified and recombinant versions of therapeutic proteins for hematology. For the majority of her career at FDA, she directed and managed chemistry, manufacturing, and controls review, serving in prior positions as Deputy Director of the Division of Cellular and Gene Therapies in the Office of Cellular, Tissue, and Gene Therapies, and Chief of the Cell Therapies Branch. She began her regulatory career as a Chemistry, Manufacturing, and Controls Reviewer of cell therapies, and a research Staff Fellow.
In her cumulative experience at CBER, Dr. Benton participated in all aspects of the regulatory review and oversight of cell and gene therapy products, from pre-submission meetings (pre-INDs), IND review, BLA review, advisory committees meetings for scientific topics and for license applications, device review (510(k), PMA, HDE), guidance and policy development, and regulation writing, revision, and interpretation.
Other highlights of her time at FDA include initiating regulatory convergence and harmonization efforts on cell therapies with global regulatory agencies including foundational efforts for the International Pharmaceutical Regulators Forum and conferences with the Asia Pacific Association of Southeast Asian Nations (ASEAN).

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