Safety Reviewer
Office of Surveillance and Epidemiology, Center for Drug Research and Evaluation, U.S Food and Drug Administration
James is a safety reviewer for anti-infective and ophthalmic drugs and biologics in the Office of Surveillance and Epidemiology in FDA's Center for Drug Evaluation and Research. His training includes a postdoctoral fellowship in anti-infective clinical and translational pharmacology under David P. Nicolau at the Center for Anti-Infective Research and Development in Hartford, CT, as well as PGY-1 and PGY-2 Critical Care residencies at Baystate Health in Springfield, MA. His professional interests include the use of real-world evidence in drug safety and using patient-specific pharmacokinetics to evaluate the relationship between drug exposure and adverse events.