Dr. Reynolds is Director of the Division of Infectious Disease Pharmacology in the Office of Clinical Pharmacology, CDER, FDA. She received her B.S. in Biochemistry from Virginia Tech, Pharm.D. from Virginia Commonwealth University, and completed a fellowship in Clinical Pharmacokinetics and Drug Development at University of North Carolina. Her work involves application of clinical pharmacology to development of antiviral and anti-infective drugs and drugs developed under the animal rule. Her interests include dose selection for sub-populations, drug interactions, risk/benefit assessment, and communication. Her work at FDA began in 1994 during a pivotal phase of HIV drug development, allowing her to experience the essential contribution of clinical pharmacology to development of drugs for a life threating disease.
Dr. Reynolds is currently a member of the following groups in CDER: Drug Interaction Working Group, Drug Interaction Labeling Working Group, Renal Impairment Working Group, and OCP IND Review MAPP Working Group. She is the FDA topic lead for the International Council for Harmonization (ICH) Drug Interaction Working Group.
Over the past three years, Dr. Reynolds participated in a number of activities related to CDER modernization efforts. She helped draft the framework for the new integrated review for assessing NDAs and BLAs and the associated new review process. She currently supports the roll-out of the integrated review process.
Dr. Reynolds is a past president of the American Society for Clinical Pharmacology and Therapeutics and was an associate editor for Clinical Pharmacology and Therapeutics.
