Sherrill Lathrop Macura, PhD
U.S. Food and Drug Administration
I completed my graduate work in Cell and Molecular Biology at the University of Vermont in 2012. This work focused on development and validation of animal models of clinical disease progression and the development of novel antibody targeted imaging and chemotherapeutic delivery devices for the treatment of malignant mesothelioma and melanoma. My post graduate work (2012-2015) was conducted at the Department of Veteran Affairs and Dartmouth College conducting Clinical Trials in collaboration with the Eastern Virginia Medical School for the development of new viral transmission and replication inhibitors for HIV. Transitioning from bench research to regulatory review I have been at the FDA from 2015 to present conducting pre-market reviews as lead reviewer for The Dental Branch in the Center of Devices and Radiological Health. In this position, I conduct comprehensive, scientifically-based reviews and evaluations of various regulatory premarket submissions providing recommendations, while working interactively with sponsors to ensure the safety and effectiveness/substantial equivalence of medical devices entering the market for interstate commerce. I specialize in biocompatibility and sterility studies, preclinical and clinical study evaluation as well as more complex or combination device reviews.