Yelizaveta (Lisa) Torosyan, MD, PhD
General Health Scientist
US. Food and Drug Administration
Dr. Torosyan is a General Health Scientist in the Division of Epidemiology of the Center for Devices and Radiological Health at FDA (DEPI/CDRH/FDA). Prior to coming to FDA, Dr. Torosyan garnered multidisciplinary expertise involving epidemiology, molecular biology, genetics and bioinformatics. A physician by training, Dr. Torosyan started her career in the academic and hospital setting, treating pediatric patients and teaching medical students. As a an MD/PhD scientist with clinical background and NIH basic research experience, she was involved in cross-disciplinary research projects on population genetics, epidemiology, pathophysiology, and treatment of genetic inflammatory disorders, cancer, and other pathologies. Her ‘omic research in particular was focused on the selection of candidate markers based on bioinformatics approaches utilizing pre-existing open-source data for hypothesis generation and data cross-validation.
After joining FDA in 2012, Dr. Torosyan applied her clinical background and research expertise to the regulatory review and research pertaining to various devices and in vitro diagnostics and involving the broad areas of orthopedics, rheumatology, pulmonology/anesthesiology, cancer, and diabetes. As a reviewer, she conducts reviews for the mandated Post-Approval Studies and Postmarket Surveillance (522 Section) Studies. As a member of the Metal-on-Metal, Pre/Post-Market Balance, Infrastructure working groups and signal management teams, she contributes to the device-related gap analysis, HIVE-based infrastructure development, and detection of potential safety signals. She is also involved in the MDEpiNet-affiliated activities on expanding conventional device surveillance by incorporating Translational Epidemiology approaches and developing the national infrastructure for postmarket surveillance of medical devices. Dr. Torosyan’s regulatory research is aligned with Precision Medicine initiatives and is specifically aimed at new evidentiary approaches integrating non-conventional (e.g., ‘omic) data and developing an in silico framework for identification of new endpoints, markers, and risk predictors for more predictive evaluation of real-world device performance.
Dr. Torosyan shared her experience and research findings in FDA-affiliated as well as national and international meetings such as the International Conference of PharmacoEpidemiology (ICPE). She authored and co-authored peer-reviewed publications in journals such as Cell, American Journal of Human Genetics, Proteomics Clinical Applications, Cancer Research, Oncogene, and Clinical Orthopaedics and Related Research.