Yale-Mayo center formed to advance regulatory science

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

The award will utilize the strengths of both institutions to address challenges presented by transformations in medical product development. Its goal is to 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; build FDA capacity and capability to deploy advanced analytic methods; and 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.

“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,” says Joseph S. Ross, M.D., M.H.S., associate professor of medicine (general medicine) and of public health (health policy), who is principal investigator of the award.

Ross says Yale’s role in the initiative reflects the achievements and support of the Schools of Medicine, Public Health, Management, and Law, as well as the Center for Outcomes Research and Evaluation at Yale New Haven Health.