FDA awards UNC and partner universities up to $50 million for new research center

Operations for the Research Triangle Center of Excellence in Regulatory Science and Innovation (CERSI) will officially begin this September through a grant awarded by the Food and Drug Administration. 

The grant will provide up to $50 million in funds to the Triangle CERSI.

A collaboration between the FDA and several North Carolina universities, the Triangle CERSI is designed to investigate questions regarding the treatment and detection of diseases through drugs and devices. 

Along with UNC, researchers from Duke University, N.C. State University and N.C. Central University will be affiliated with the new center.

Paul Watkins, a professor at UNC's Eshelman School of Pharmacy, was one of four principal investigators who assembled the initial application for the center. Watkins said the grant recognizes the Research Triangle as a leading area for scientific expertise, calling the new Triangle CERSI a “one-stop shop” for the FDA. 

In contrast to other organizations, such as the National Institutes of Health, which are primarily focused on biomedical research, the CERSI is designed to answer research requests from the FDA.

“It does shed a very favorable light on the quality of the scientists and what they’re doing in the Triangle area,” Watkins said. “I think it will be helpful in both recruitment and retention of the top faculty, but I also think it’s contributing to the increased momentum sitting in the Triangle nowadays, the renaissance of the (Research Triangle Park), and this is going to help that, certainly on a national image level, but also having these kinds of direct connections to the FDA.”

The Triangle center is the newest CERSI to be founded by the FDA, and joins other national locations at universities such as the University of Maryland and Johns Hopkins University. 

While the Triangle CERSI will largely be a virtual center due to having multiple institutions, facilities for in-person gatherings will be provided courtesy of the Burroughs Wellcome Fund, a non-profit medical research organization. 

According to Watkins, the center will open up direct connections between the Triangle and the FDA. 

Although the FDA has funded research in the Triangle area in the past, Watkins said it was a more cumbersome process. With the new Triangle CERSI, he said a project can begin within two months, an asset to both the FDA and principal investigators. 

Lisa LaVange, professor and chair of the Department of Biostatistics at the Gillings School of Global Public Health, said the main purpose of the CERSI is to foster research in the regulatory sciences. 

“It's basically research into areas that can contribute to the development of safe and effective medicine and to their evaluations,” LaVange said.

LaVange said the field included research into the toxicology of drugs, clinical trial designs and the post-marketing activities of drugs once approved and on the market. She said many of the project proposals were variable and diverse.

Within this focus, the grant application for the Triangle CERSI featured 38 proposals from a range of disciplines, including novel statistical methodology, patient-reported outcomes, and artificial intelligence and machine learning applications.

One proposal explored methods for local pharmacies and underserved communities to be more effective in monitoring and limiting opioid overdoses, Watkins said. 

LaVange said one of the proposals was from the biostatistics department at Gillings and was a project that used Bayesian methods for clinical trial design using external data for control. 

Robert Mentz, chief of the Heart Failure Section at the Duke University School of Medicine and co-principal investigator of the Triangle CERSI, said mentorship is another key goal of the center. He said they hope to do so by supporting junior investigators and trainees and improving diversity and inclusion. 

Ultimately, Mentz said he hoped the center will act as both an incubator and an accelerator for not only the sciences but also for investigators, ranging from those beginning their careers as medical students to senior investigators. 

“We want to make sure that all the insights gleaned from the activities of the CERSI are translated to the broad community,” Mentz said. “We want to make sure that the science can be conveyed to the individuals that it matters to in a way that's clear, regardless of level of educational background or socioeconomic status.”

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