Center for Excellence in Regulatory Science and Innovation
In 2016, Yale University and Mayo Clinic collaboratively established a Center for Excellence in Regulatory Science and Innovation (CERSI) program, which is funded by consecutive Food and Drug Administration (FDA) grants. CERSI programs — collaborations between the FDA and academic institutions — aim to advance regulatory science through research, education and scientific exchanges.
Together, Yale and Mayo Clinic have created a collaborative infrastructure that supports several areas of focus in the FDA's strategic plan for regulatory science, including:
- Stimulating innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes
- Harnessing diverse data through information sciences to improve health outcomes
- Strengthening social and behavioral science to help consumers and professionals make informed decisions about regulated products
The multidisciplinary collaborative team seeks to address gaps in knowledge surrounding the safety and efficacy of medications and other regulated medical products. 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's strategic plan.
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.
More information about CERSI programs is available on the FDA website.