Professor and Dean
Loyola University of Chicago
I am Professor and Founding Dean of the Parkinson School of Health Sciences and Public Health, Loyola University Chicago. Trained in epidemiology at Johns Hopkins University and board-certified in public health, my academic research and practice focuses on accelerating the national translation of medical innovation into practice, with a specific focus on drug warnings. I have advised the FDA on issues of drug safety and risk management in over 50 advisory committee meetings and expert panels having served on the Drug Safety and Risk Management and chaired the Pulmonary Allergy Drug Advisory Committees. I recently completed a 2-year Visiting Scientist position with FDA to advance regulatory science affecting pharmaceutical risk management (REMS program) design, implementation and evaluation.
My career interests have been at the intersection applied clinical and translational research and dissemination and implementation science. For the first half, I was a product development manager in the pharmaceutical industry where I directed late-stage clinical development and commercialization teams to advance new claims and indications for OTC and prescription drug products in North America and Europe. During the second half of my career, I have been in academia and received funding from the National Institutes of Health (NIMH, NCI, NIDDK, NHLBI), Agency for Healthcare Research and Quality, and other public and private organizations. My current research is funded by the Centers for Disease Control and Prevention and the NIH National Center for Advancing Translational Science.
Within ISPE, I co-Chair the Special Interest Group on Benefit-Risk Assessment, Communication, and Evaluation (BRACE) and have served for two years on the ICPE scientific program planning committee.