The Food and Drug Administration will award up to $50 million over five years to help Duke and the University of North Carolina at Chapel Hill establish a new research center.
The award, announced earlier this month, is part of the FDA’s Centers of Excellence in Regulatory Science and Innovation program, which was “established to foster robust and innovative approaches to advance regulatory science.” The new center, the Research Triangle CERSI, will be the newest of five CERSIs across the country.
The Triangle CERSI will be led by Susan Halabi, James B. Duke distinguished professor of biostatistics and bioinformatics; Robert Mentz, associate professor of medicine and population health sciences at Duke; Ehsan Samei, Reed and Martha Rice distinguished professor of radiology at Duke, and Paul Watkins, Howard Q. Ferguson distinguished professor of pharmacy at the UNC Eshelman School of Pharmacy.
The center will engage faculty across the area, including those from Duke, UNC Chapel Hill, North Carolina State University and North Carolina Central University.
“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,” Mentz said.
According to Halabi, the CERSI will begin operations in September. Halabi wrote in an email to The Chronicle that there will be “several opportunities” for students to collaborate with investigators at the new center, where there will be projects having to do with “novel statistical methodology, machine learning, imaging and patient reported outcomes.”
“Education in regulatory science [will be] a priority of the new center,” Samei wrote in an email to The Chronicle. “We will use the projects of the center to involve students across all [T]riangle universities including Duke.”
Samie further noted that the projects undertaken will serve to “inform and enrich FDA processes for faster qualification of products and drugs.” The grant application for the center included 38 proposed projects.
“The Triangle CERSI is a significant opportunity for our scholarly communities to curate and direct our intelligence towards addressing an important societal need for proficient and efficient regulatory approval and oversight,” Samei said.
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Jazper Lu is a Trinity junior and managing editor of The Chronicle's 119th volume.