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Kimberly Maxfield, PhD

Pharmacologist
FDA
Silver Spring, MD

Dr. Kimberly Maxfield is a PhD pharmacologist and regulatory scientist whose career focuses on the intersection between public health, drug development, policy, and regulation of therapeutic proteins. Currently, she serves as the scientific lead on the Biosimilar User Fee Act (BsUFA) III regulatory research pilot program in the U.S. Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars (OTBB). Prior to OTBB, Dr. Maxfield led development of evidence-based guidance and policy in the FDA Office of Clinical Pharmacology (OCP). She also led the CDER Immunogenicity Review Committee (IRC) defining and leading multidisciplinary and integrated approaches to immunogenicity risk assessments. Additionally, Dr. Maxfield established and administered the CDER postdoctoral fellowship program for training in policy development and regulatory science that aimed to promote therapeutic individualization through policy evaluation and development.

Dr. Maxfield received her PhD in Pharmacology from the School of Medicine at the University of North Carolina at Chapel Hill. Due to a laboratory relocation, she performed a half of her dissertation research at University of Texas Southwestern Medical Center (UTSW) in Dallas, Texas. Her doctorate focused on the systematic dissection of tumor cell biology through pan-genomic high throughput screening for the rational design of new therapeutic and dose combinations. Dr. Maxfield completed post-doctoral fellowships at the National Academies of Sciences, Engineering, and Medicine (NASEM) and at the FDA in health policy and regulatory science. The NASEM fellowship focused on the clinical implementation of immunotherapies and drug development paradigms in oncology. The FDA fellowship addressed the public health impact of FDA external engagement. Also, as a life-long learner, she is currently enrolled in a Master of Public Health with a Global Health Certificate program to focus on intersecting her scientific, technical, and regulatory experience with public health practice and policy.

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