UCSF-Stanford Center of Excellence in Regulatory Science and Innovation

Abstract: The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) supports FDA’s mission of protecting the public health through collaborative research, as well as training and outreach activities. Our CERSI, launched in 2014, brings together a world-class team of scientists from two outstanding academic institutions to focus on innovative regulatory science research in collaboration with FDA scientists—generating new knowledge, tools and standards that help FDA in its regulatory decision-making. Our research informs regulatory processes, guidances, and policies relevant to the evaluation and monitoring of safe and effective medical products. The major goal of this five-year competing renewal application is to advance regulatory sciences primarily through collaborative research projects between scientists at the FDA and faculty at UCSF and Stanford. A secondary goal is to provide education and training to students, postdocs, and scientists in medical product development. Our CERSI offers research projects grounded in the enormous research breadth of the two academic institutions: UCSF and Stanford. Eight projects are included in the first year of funding (selected from over 30 submitted proposals). Several of the eight projects are focused on the use of artificial intelligence and real-world data, a major strength of both institutions, to advance the FDA mission. In addition, we include research focused on novel clinical trial design in diverse populations, a multiscale research project that uses AlphaFold on highly polymorphic pharmacogenes to model adverse drug events, and projects focused on advancing digital health tools and vaccine surveillance. These eight projects address research priorities at the FDA including those of the Center for Drug Evaluation and Research (CDER); the Center for Biologics Evaluation and Research (CBER); and the Center for Devices and Radiological Health (CDRH). We also include 18 half-page research proposals that may be funded after the first year; these projects will advance research in data analytics, clinical trial design, digital health, biologics, and special populations. We include a range of education and outreach activities of our CERSI, which include fellowship and diversity scholarship programs, courses, workshops, and summits. We describe top-level scientific advisory board and management and financial teams which have guided our CERSI over almost 10 years in collaborative research, training, and outreach interactions with the FDA. The UCSF-Stanford CERSI provides a West Coast hub for FDA collaborative science and has facilitated the growth of regulatory science at UCSF and Stanford University.