UNC-Chapel Hill and Duke Team Up to Support FDA Research

• UNC-Chapel Hill and Duke University are partners in the new CERSI, with collaboration from North Carolina State University and HBCU North Carolina Central University.
• The Triangle CERSI is the fifth CERSI and adds veterinary drug expertise from NCSU.
• UNC-Chapel Hill recently added an online master of professional science in regulatory science in the School of Pharmacy.

Graduate students studying in the North Carolina Research Triangle may have the opportunity to work with the U.S. Food and Drug Administration (FDA) to research and resolve drug-safety issues.

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) announced the Research Triangle Center of Excellence in Regulatory Science and Innovation (Triangle CERSI) on July 11 — a partnership with Duke University — that will get $50 million in funding over five years from the FDA.

BestColleges spoke with Paul Watkins — the principal investigator for Triangle CERSI at UNC-Chapel Hill, a physician-scientist in its Eshelman School of Pharmacy, and director of the Institute for Drug Safety Sciences — to learn about opportunities for the lead institutions and students.

FDA Backs Research Institutions

As a starting point, the CERSI setup allows these institutions to have a direct line for fast collaborations with the FDA, Watkins said.

"[The FDA] put together some money and said, 'Well, let's find institutions around the country with the best experts so that at the drop of a hat, we can get research going between our scientists at the FDA and scientists at these institutions,'" Watkins told BestColleges. "And it's been a successful program."

The Triangle CERSI, a partnership between UNC-Chapel Hill and Duke, is the newest of the CERSIs nationwide. Collaborators North Carolina Central University, one of the country's historically Black colleges and universities (HBCUs), and North Carolina State University (NCSU) can participate in research projects but receive no direct funding.

The Triangle CERSI is the fifth CERSI in the nation alongside the University of Maryland; the University of California, San Francisco in partnership with Stanford University; Johns Hopkins University; and Yale University in partnership with the Mayo Clinic.

Triangle CERSI also partners with the Burroughs Wellcome Fund, a grant organization for researchers from degree-granting institutions to improve the general environment for science.

"If the FDA has a question that they think is important to answer, and if they can identify funding to do it, they will then notify the CERSIs, all five of us now, saying, 'We're really interested in whatever,'" Watkins said.

From there, a researcher will submit a one-page proposal to the FDA. The FDA will ask the researcher to submit a full five-page proposal if it approves the project.

"It goes back to them, and they say yes or no. And if it's yes, you get your money, you start right off, which is not the usual way at all to get money from the government to do research."

Watkins added that unlike the National Institutes of Health (NIH), the FDA is not interested in funding cutting-edge research. The CERSIs are assigned short-term projects focused on specific questions. The Triangle CERSI has five years of funding with the possibility of extension — so the FDA can continue to get quick answers to its questions.

Watkins said which projects the FDA will fund and how much funding the Triangle CERSI receives is related to project success, FDA funding, inflation, and the GOP-led restriction on discretionary spending.

Opportunities for Students

UNC-Chapel Hill's Eshelman School of Pharmacy will start a new online master's degree program in regulatory science in the fall.

Watkins said all these Triangle CERSI research projects on drug safety will certainly have graduate and postdoc students involved.

What Kinds of Projects Will CERSI Handle for the FDA?

"People ask, 'Well, what's your theme? How did you become one of the five? Did you fill in a gap that the others didn't have?'" Watkins said.

"We said, 'We can do most of what you'd want. Just tell us what you want.' So, there is no common theme."

Watkins said while the Triangle CERSI did not fill too many gaps, NCSU's veterinary medicine expertise for drugs and drug trials in animals is a new addition to the CERSI arsenal.

The project Watkins is most excited about is one of the original 38 proposals the FDA still hasn't called him back for yet.

He proposed a short-term project determining whether a bad drug reaction in a clinical event was related to the drug or another factor like an antibiotic or a person's genetic risk.

"I think they may still fund it," said Watkins. "We have FDA collaborators who want to do it. The question is, do they have the money to do it?"

Over at Duke, Ehsan Samei, medical physicist and principal investigator, proposed advanced modeling and artificial intelligence to do clinical trials with virtual avatars to inform human trials. Watkins said that the technology is phenomenal but very expensive.

Watkins said the FDA's creation of the Triangle CERSI is part of a research renaissance in the Raleigh-Durham-Chapel Hill area.

"The Research Triangle Park itself was an experiment that was hugely successful and then imitated around the country to take land in the middle of nowhere and suddenly give it away for free to industry to build there," he said.

Watkins said other areas of the country mimicked the model, which took business away from the Triangle. Recently, the Triangle has been making it easier to retain and recruit top faculty by increasing commerce and research infrastructure.

"There aren't many of these centers, and the idea of having the top academic people that are also wired into the FDA directly is a plus."

And the project gives these two longtime, fierce college rivals a chance to work together.

Watkins said there's a ton of athletic competition between UNC-Chapel Hill and Duke — with basketball, football, and his favorite, tennis.

"But athletics aside, when we partner with Duke, we almost always get whatever grant you want," said Watkins. "I mean, the two institutions together are a force that is staggering in terms of the expertise and equipment and infrastructure and ability to do things. It's awesome."