AMR Conference Speaker Grace Yan Danielsen

Grace Yan Danielsen

Deputy Director of the Division of Infectious Disease Pharmacology, U.S. Food and Drug Administration (FDA)

Dr. Grace Danielsen is Deputy Director of the Division of Infectious Disease Pharmacology in the Office of Clinical Pharmacology at the U.S. Food and Drug Administration (FDA). She received her PhD in Pharmaceutical Sciences from the University of North Carolina, Chapel Hill. Her work at FDA involves the application of clinical pharmacology and translational medicine to the development and evaluation of antiviral and anti-infective drugs and drugs developed under the animal rule. Many indications evaluated under the animal rule are related to counter-terrorism efforts, such as plague and anthrax. Dr. Danielsen is actively engaged in guidance development and regulatory science in the areas of clinical pharmacology and infectious diseases. She helped draft several new or updated guidance documents related to clinical pharmacology and antimicrobial drug development. She also serves on the FDA review board to evaluate research proposals from external investigators and oversee the progress of the FDA funded antimicrobial research.