The Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI), a joint effort between Yale University, Mayo Clinic and the Food and Drug Administration (FDA) to conduct research and develop tools to support regulatory decision-making, has received renewed FDA funding to advance its efforts to improve public health.
The renewed funding — spanning 5 years and up to $50 million —will support a wide range of research projects focused on areas such as the development of innovative scientific approaches, improved regulatory decision-making and better patient outcomes.
The continued collaboration will enable both institutions to advance their efforts to improve the safety and availability of medical products and treatments.
"The CERSI grant supports research that addresses the FDA’s highest priority questions in regulatory science," says Molly M. Jeffery, Ph.D., scientific director at Mayo Clinic for Emergency Medicine Research and the co-Principal Investigator for Yale-Mayo Clinic CERSI. “The work we do in collaboration with the FDA results in immediate impact both for scientists and policymakers and for the public.”
The Yale-Mayo Clinic CERSI is one of a few cooperative agreements that work to support the FDA strategic plan for regulatory science. The CERSIs’ work includes promoting innovation in clinical evaluations and personalized medicine, harnessing diverse health data through information sciences and strengthening social and behavioral science to help consumers and professionals make informed decisions about regulated products.
Dr. Jeffery notes that the grant renewal highlights the importance of continued efforts to support research that protects and advances public health.
"One of the best things about the CERSI is that the work we do directly influences policy and practice," says Dr. Jeffery. "The FDA works with the CERSIs to promote projects that answer their most pressing questions."
The CERSI program is led by the FDA's Office of Regulatory Science and Innovation (ORSI), in collaboration with FDA scientific experts and funding offices.
Mayo Clinic's program is coordinated through the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery and the Mayo Clinic Knowledge and Evaluation Research Unit. It also leverages another of the Kern Center's collaborative relationships by using data available through the OptumLabs Data Warehouse.
More information about CERSI programs is available on the FDA website