FDA awards $50 million to Triangle universities for joint work on drug development process, regulatory oversight, public health information

The U.S. Food and Drug Administration will award up to $50 million over five years to the University of North Carolina at Chapel Hill and Duke University to establish the Research Triangle Center of Excellence in Regulatory Science and Innovation (CERSI).

The FDA expects the Triangle center to provide "essential new information, as well as infrastructure and tools to shorten the drug and device development process, to advance public health and to inform regulatory decision making and guidance documents."

The funding will be available on Sept. 1.

The center will serve as an accelerator to meet the FDA’s evolving need to access the most current scientific knowledge, and to also create a tight-knit community for regulators, academia, industry and other stakeholders.

The Triangle will be the site of the fifth CERSI in the nation. Other CERSIs are based at the University of Maryland, the University of California at San Francisco in partnership with Stanford University, Johns Hopkins University, and Yale University in partnership with Mayo Clinic.

The Triangle CERSI will be led by Paul Watkins with the UNC Eshelman School of Pharmacy and will include faculty from the UNC Eshelman School of Pharmacy, UNC School of Medicine, UNC Gillings School of Global Public Health, UNC School of Data Science and Society, Duke University School of Medicine, Duke University Pratt School of Engineering, Duke University’s Center for Virtual Imaging Trials, the Duke Clinical Research Institute, the Colleges of Engineering and Veterinary Medicine at NC State, the NCCU College of Health and Sciences, NCCU College of Arts, Social Sciences and Humanities, the NCCU Biomanufacturing Research Institute and Technology Enterprise and the NCCU Julius L. Chambers Biomedical and Biotechnology Research Institute.

“We are delighted to be awarded the fifth national CERSI, which is a testament to the outstanding scientists at Carolina and Duke, along with our collaborating institutions NC State and NCCU. This center will support many joint research projects involving FDA scientists to better inform regulatory decisions and thereby improve public health,” Watkins said.

Dr. Robert Mentz, associate professor of medicine and population health sciences and chief of the heart failure section at Duke University School of Medicine and a Duke Clinical Research Institute faculty member, said, “We are uniquely positioned to leverage the tremendous strengths of Duke’s trial and observational research infrastructure, machine learning, statistical knowledge, in silico trials, and imaging expertise to answer meaningful questions for patients and other key stakeholders.”

The expert knowledge Triangle universities can provide will be helpful in public health emergencies.

"Preparation for the next pandemic is something that the FDA [U.S. Food and Drug Administration] is very interested in, and fortunately, we have great expertise – unparalleled expertise actually – at our area universities to really help guide the FDA to make the right decisions," Watkins said.

Watkins said the FDA has a wide purview and the experts can guide decision-making.

"They can, of course, ask for consultants, but there are areas where there are gaps in knowledge, and that's what this is designed to do," Watkins said. "Use our very top scientists to help them fill in those gaps."