FDA grant establishes Yale-Mayo Clinic center to advance regulatory science

The U.S. Food and Drug Administration (FDA) has awarded Yale and Mayo Clinic a grant up to $6.7 million over two years to establish a Center of Excellence in Regulatory Science and Innovation (CERSI).

The award will support a collaboration bridging the campuses of Yale and Mayo Clinic, leveraging the strengths of both institutions to create a novel partnership to support the FDA’s regulatory mission and advance regulatory science through research, education, and scientific exchanges.

FDA CERSIs foster collaborations to primarily address the challenges presented by transformations in medical product development. The goal of the Yale-Mayo CERSI is to: 1) take advantage of routinely collected, real-world data sources, existing clinical trial data, and genomic and biobank data in order to inform regulatory decision-making; 2) build FDA capacity and capability to deploy advanced analytic methods, and; 3) disseminate the knowledge generated.

This information will be used to ensure patient-centered regulatory decision-making; create better-informed regulators, manufacturers, clinicians and patients; and support shared decision-making. Additional specific aims over the two-year award period include: support for training and career development in regulatory science; support for scientific exchanges and learning across institutions; high-impact research projects using real-world data sources; and collaborations among stakeholders at Yale, Mayo, the FDA, industry, and across the CERSI network, which also includes University of Maryland, Georgetown University, UCSF-Stanford University, and Johns Hopkins University.

“This cooperative grant creates a unique opportunity for the faculty and trainees at Yale and Mayo Clinic to use their combined research expertise to examine massive amounts of data and engage with the FDA in meaningful, data-driven change, supporting efforts to protect the public’s health, and improve health care for patients,” said Dr. Joseph Ross, associate professor of medicine and public health at Yale and principal investigator of the award.

Ross, who co-leads the Yale-Mayo CERSI with Nilay Shah, associate professor of health services research at Mayo Clinic, said that the initiative reflects the achievement and support of the Yale Schools of Medicine, Public Health, Management, and Law, as well as the Center for Outcomes Research and Evaluation at Yale New Haven Health, along with the Division of Health Care Policy and Research, Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery and Knowledge and Evaluation Research Unit at the Mayo Clinic, reflecting the culture of interdisciplinary collaboration across both institutions.

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