Speakers

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 is serving as a Lead of Regulatory Affairs, US at Biocon Biologics, a biosimilar developer. Prior to Biocon Biologics, she was the scientific lead on the Biosimilar User Fee Act (BsUFA) III regulatory research pilot program in the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars (OTBB). Before OTBB, Kimberly 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, Kimberly performed genetics and oncology clinical pharmacology reviews and established and led the postdoctoral fellowship for training in policy development and regulatory science.