Full Name
Dr. Sara Brenner
Job Title
Chief Medical Officer & Associate Director for Medical Affairs
Speaker Bio
Dr. Sara Brenner, MD, MPH is a preventive medicine and public health physician serving as the Chief Medical Officer for In Vitro Diagnostics and Associate Director for Medical Affairs in the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA) where she advises leadership on regulatory premarket and post-market compliance and surveillance as well as broader initiatives to promote and protect public health across the medical technology landscape. She contributes to decisions regarding policy development, program execution, and short- and long-range program goals and objectives. Dr. Brenner provides medical, public health, technological, and scientific direction to a multidisciplinary professional staff engaged in developing and implementing standards for the safety and effectiveness of medical devices marketed and used through the United States.
From February 2020-May 2023, Dr. Brenner supported the National COVID-19 Response at multiple levels, focused on diagnostics, data, and leveraging technology across the interagency response, including serving as the Diagnostic Data Lead on the U.S. Department of Health and Human Services (HHS) Data Strategy and Execution Workgroup (DSEW) for two years. She and her team worked across the interagency to advance diagnostic data quality, harmonization, reporting, diagnostic device performance, and leverage emerging technologies for public health, medical, and policy decision-making during the pandemic. They communicated directly with a broad stakeholder community across the U.S. including states, territories, and local health departments and advance both policy and technical recommendations and implementation strategies with senior leaders in HHS and the White House. Her championing of these efforts over two years helped to secure significant resources for formal program development at FDA in the areas of digital diagnostics and laboratory data interoperability. The resulting FDA Diagnostic Data Program, launched in November 2021, endeavors to improve the quality, interoperability, and utility of diagnostic data for direct patient care and population health. The goal of the program is to develop a robust infrastructure for improving data portability from of over-the-counter (OTC), point-of-care (POC), and laboratory in vitro diagnostic (IVD) data within and between institutions and individuals. It also serves as a model for how high-quality data from both conventional and unconventional sources, including real-world data, can be used to support regulatory decision-making across other medical product spaces. In FY22-24, the FDA Diagnostic Data Program has executed approximately $100M in extramural awards and contracts to support its mission of collecting and utilizing high-quality data from both inside and outside of clinical laboratories for regulatory decision-making and clinical care.
Prior to joining FDA, Dr. Brenner served as a Senior Policy Advisor in the White House Office of Science and Technology Policy (OSTP) with a broad portfolio in biomedical science, technology, and human health. From within the Executive Office of the President (EOP), Dr. Brenner worked with U.S. Departments and Agencies, the Office of Management and Budget, the National Security Council, the Domestic Policy Council, and other White House components to develop national policy relevant to health care, medical technology, biomedical science, innovative early-stage research, and workforce training and education. Her portfolio included focus areas in health data interoperability, privacy, and national security, interagency coordination in biological and health sciences, research business models and reducing burdens on the national research enterprise, open science/open data initiatives, translational science and commercialization, promotion and protection of the U.S. bioeconomy, biomedical research in microgravity (space), national public health response to combat the opioid crisis, Veterans’ suicide prevention (PREVENTS), and risk assessment and mitigation related to human exposures to contaminants of emerging concern. Dr. Brenner worked closely with colleagues throughout the EOP and across numerous agencies to develop high level policy priorities, actions, and implementation strategies. She also engaged numerous and diverse stakeholders from the public and private sectors in carefully crafting recommendations, Jan 2024 policy options, and solutions to the most pressing needs and opportunities at the nexus of technology and human health.
Prior to joining the U.S. Federal Government, Dr. Brenner was a tenured faculty member at the SUNY Polytechnic Institute Colleges of Nanoscale Science & Engineering (CNSE) where she was an Associate Professor of Nanobioscience, the Assistant Vice President for NanoHealth Initiatives, and the Director of the MD/PhD Program in Nanomedicine. Dr. Brenner’s academic research advanced technology applications in the life sciences, including medicine and public health, as well as safeguarded against unintended health effects of exposure to engineered nanomaterials and emerging advanced materials. She led health initiatives related to nanoscale and advanced material applications in medicine, as well as conducted research with diverse stakeholders to evaluate exposure in the workplace, consumer marketplace, and environment. She spear headed the development and operation of the NanoHealth and Safety Center at CNSE, a $10M public-private partnership to address gaps in understanding of the safety and risk associated with the unique characteristics of nanoscale materials used in advanced manufacturing. Her research team incorporated theory from many disciplines including physics, engineering, biology, genetics, medicine, public health, epidemiology, industrial hygiene, and environmental science to advance risk assessment and reduction strategies for occupational exposures, monitor materials that may impact population health and public safety, and develop industrial practice standards for product safety. Dr. Brenner also was the CNSE Program Director of the MD/PhD program in Medicine and Nanoscale Science or Engineering, a program that she helped co-found with SUNY Downstate Medical Center. It is the first dual-degree clinical training program in nanomedicine that aims to produce a new, hybrid generation of physician researchers poised to integrate technology and medicine from benchtop to bedside. Dr. Brenner received her MD from the University of Iowa Carver College of Medicine, her MPH from the SUNY UAlbany School of Public Health (Health Policy and Administration), and BS in genetics (minor in philosophy) from Iowa State University. She trained in Internal Medicine at Evanston Northwestern in Chicago and Preventive Medicine and Public Health at the New York State Department of Health and SUNY UAlbany School of Public Health.
Sara Brenner