Kimberly Benton, Ph.D.


Former FDA; regulatory and CMC expert with extensive knowledge of regulations and policy related to CGT and beyond

About Kimberly

Dr. Benton specialized in cell and gene therapy products during her multi-decade career 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 (OTAT). 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.

Kim 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, Kim 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).

Dr. Benton’s experience with DHC clients often includes an element of how best to achieve the client’s regulatory goal(s) by ensuring that information presented to the regulatory body in meetings or in regulatory submissions is presented as clearly and effectively as possible.


  • KA Benton. FDA Perspectives on Characterization and Comparability of Cellular Therapy Products. 2003. BioProcessing Journal, Jan/Feb, 44-47.
  • Areman, E, Benton, K, McFarland, RD. Regulatory considerations in manufacturing, product testing, and preclinical development of cellular products for cardiac repair, in “Cell Therapy and Tissue Engineering for Cardiac Repair: From Basic Research to Clinical Applications,” Dib, N, Taylor, DA, Dietrich, EB, eds., Springer Scientific, New York, 2005.
  • McCright, B, JM. Dang, DA Hursh, DS. Kaplan, R Ballica, KA Benton, and AL Plant. Synopsis of the FDA-NIST Co-Sponsored “In Vitro Analyses of Cell/Scaffold Products” Workshop. 2009. Tissue Engineering, 15:3, 1-6.
  • Arcidiacono, JA, JW Blair, KA Benton. US Food and Drug Administration international collaborations for cellular therapy regulation. 2012. Stem Cell Research & Therapy, 3:38.
  • Bailey AM, Arcidiacono J, Benton K, Taraporewala Z, Winitsky, S. United States Food and Drug Administration Regulation of Gene and Cell Therapies; In Cristina M and Serabian M (Eds): Regulatory Aspects of Gene and Cell Therapy Products: A Global Perspective; Advances in Experimental Medicine and Biology Springer Series Press; September 2015.


University of Alabama at Birmingham
Ph.D. in Microbiology

Salisbury State University
B.S. in Biology, Minor in Chemistry

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