The Yale-Mayo Clinic FDA Center of Excellence in Regulatory Science and Innovation (CERSI) was recently renewed with an award of up to $50M for five years from the U.S. Food and Drug Administration (FDA). The partnership between Yale School of Medicine (YSM) and Mayo Clinic provides academic scientists the opportunity to perform regulatory science research, training, and education in collaboration with the FDA.
Joseph Ross, MD, MHS, professor of medicine (general medicine), YSM, and of public health (health policy and management), Yale School of Public Health, explains the CERSI’s scope.
“We bring together faculty and FDA scientists to work on a wide range of research efforts, from running clinical trials to working with large data sets, to performing pre-market evaluation work to figuring out endpoints that should be used in clinical trials or other patient reported outcome measures. The CERSI is a great opportunity for scientists at Yale and Mayo Clinic to work directly with folks in the FDA so that their work has direct policy relevance,” said Ross.
Ross co-leads the effort with health economist and health services researcher Molly Jeffery, PhD, MPP, associate professor of emergency medicine and assistant professor of health services research at Mayo Clinic.
The duo harmonizes research, educational, and training efforts across the two institutions and with the FDA. “When a specific center has a project that they're interested in that requests proposals, Molly and I think through who at our institution would be most interested in applying for the project funding and connect them with the opportunity,” said Ross.
One of the many perks of working with the CERSI is the possibility of starting on a research endeavor quickly.
“The CERSI provides direct contact and opportunity for collaboration with policymakers. It also provides an opportunity to get your work moving more quickly. Because the CERSI is set up as a U01 mechanism, the FDA is continually asking for new project ideas and providing new funding. It is different than submitting projects through other organizations with longer lead times,” explained Ross.
The Yale-Mayo Clinic CERSI combines efforts across nearly 100 faculty, trainees, and staff across both institutions and has completed over 20 projects since its inception. Jessica Ritchie, MPH, PMP; Michelle Bernabeo; and Leah Springer serve as project staff.
Recent projects completed by the CERSI that resulted in publication include:
- Understanding the safety and efficacy of generic drugs used for hypothyroidism
- Opioid protocol for acute pain pathways
This announcement marks the second grant renewal since the Yale-Mayo Clinic CERSI launched in 2016. For more information, visit Yale University-Mayo Clinic CERSI.