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K. Reynolds: FDA experiences with drug development for pediatric patients


Dr. Kellie Reynolds is deputy director of the Division of Clinical Pharmacology 4 in the Office of Clinical Pharmacology, Center for Drug Evaluation and Research, FDA. Dr. Reynolds received her B.S. in Biochemistry from Virginia Tech and her Pharm.D. from Virginia Commonwealth University. She completed a fellowship in Clinical Pharmacokinetics and Drug
 Development at the University of North Carolina at Chapel Hill.  Her current work involves the application of clinical pharmacology to the development of anti-viral, anti-infective, and transplant drugs.  Within these therapeutic areas, Dr. Reynolds’ professional and research interests include dose selection for individual patient sub-populations, factors affecting drug absorption, drug metabolism, drug interactions, and the communication of appropriate drug use information to health care providers and patients.
 
Dr. Reynolds has given many national and international presentations on the clinical interpretation of in vitro drug metabolism data, in vivo drug interaction data, and the design of in vivo drug interaction studies.  She has published a number of peer-reviewed articles and book chapters that address drug interactions.   She participates in meetings of the Pediatric HIV/AIDS Treatment Public Private Partnership.  Dr. Reynolds is a member of the American Society of Clinical Pharmacology and Therapeutics.  She serves as an associate editor for the journal Clinical Pharmacology and Therapeutics