In 2016, Yale University and Mayo Clinic collaboratively established a Center for Excellence in Regulatory Science and Innovation (CERSI) program. CERSI programs — collaborations between the Food and Drug Administration (FDA) and academic institutions — aim to advance regulatory science through research, education and scientific exchanges. More information about CERSI programs is available on the FDA website.
The Yale University and Mayo Clinic CERSI program, funded by an FDA grant for up to $6.7 million over two years, seeks to address gaps in knowledge by developing tools to measure regulated medical products' safety and efficacy. As new discoveries are made and new understanding is developed, the Yale and Mayo CERSI team will work together to translate those discoveries into improved practice.
Further, Yale and Mayo Clinic will inform new and revised health care policy and support regulatory decision-making in alignment with the FDA mission of stimulating innovation, harnessing diverse data, and strengthening social and behavioral science to improve product development and patient outcomes.
The CERSI's work also can help regulators, manufacturers, clinicians and patients make informed decisions about regulated products, including the safety of generic drugs and the use of opioids.
The Yale University and Mayo Clinic CERSI program's specific aims include:
- Supporting the FDA's regulatory mission by leveraging Mayo Clinic's and Yale University's respective strengths, including each institution's track record of pioneering new approaches for data science and producing studies that regularly appear in top medical journals
- Providing education in regulatory science research and affairs at Yale and Mayo Clinic, including courses in the field as part of a degree program and online content
- Supporting scientific exchange at the FDA and across the CERSI network
- Conducting high-impact research in collaboration with the FDA, taking advantage of real-world data sources, including genomic and biobank data, and applying that knowledge to ensure patient-centered care and affect health care-improving change
- Pursuing other funding opportunities to leverage the FDA grant
The 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 Mayo Clinic Kern Center for the Science of Health Care Delivery's collaborative relationships by using data available through the OptumLabs Data Warehouse.