Amy B. Cadwallader, PhD is the Directory of Regulatory and Public Policy Development at the U.S. Pharmacopeia (USP) where leads development of USP regulatory and public policy positions and is responsible for the creation of evidence-based policy content to advance the supply of quality medicines and biomedical innovations. She also leads the USP Quality Institute, an independent, globally focused research department of USP with a mission to generate high-quality, forward-thinking evidence to inform open discussion, public policy, and regulatory reforms that advance the supply of quality medicines globally. Dr. Cadwallader received her doctorate in pharmacology and analytical toxicology from the University of Utah, her M.S. in biology/forensic science from Virginia Commonwealth University, and B.S. in chemistry and biochemistry and molecular biology from Dickinson College.