Skip to main content

Triangle CERSI

Informing regulatory decisions and improving public health

Triangle CERSI logo

Developed in partnership with The University of North Carolina at Chapel Hill, Duke University, North Carolina Central University, North Carolina State University and the Burroughs Wellcome Fund

MPS in Regulatory Science

Interested in becoming a regulatory scientist? The Eshelman School of Pharmacy offers a fully online Master of Professional Science in Regulatory Science.

The U.S. Food and Drug Administration awarded $50M 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. The Center is the fifth one to be awarded and will also involve collaborations with North Carolina State University and North Carolina Central University. Working collaboratively with the FDA, our overarching goal is to serve as an accelerator hub to provide an abundance of essential new information, infrastructure, and tools to shorten the drug and device development process, to advance public health, and to inform FDA activities in ways that complement other CERSI's and contribute to achieving the goals of the national CERSI program.

 

Opportunity

New drugs, devices and technologies are constantly bursting onto the scene, aided by the use of artificial intelligence and other methodological innovations. For regulatory agencies, such as the FDA, keeping pace can be a challenge.

 

Solution

The Triangle CERSI unites the University of North Carolina at Chapel Hill, Duke University, North Carolina State University and North Carolina Central University – and the vast network of organizations and industries throughout the Research Triangle Park—to provide broad expertise and infrastructure for collaborations with the FDA where together, we’ll address the full spectrum of current and evolving needs in regulatory science.

Our capabilities in medical imaging, virtual twins and in silico trials, AI and machine learning methodologies, drug safety and pediatric clinical pharmacology coupled with our broad capabilities to address equitable race and gender representation within clinical trials will enhance the FDA’s understanding and assessment of risk and ensure continued safety and efficacy of products used by the public.

Showcasing the Triangle's Collective Strengths

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.

Headshot of Paul Watkins

Paul Watkins, PhD
Howard Q. Ferguson Distinguished Professor of Pharmacy at the UNC Eshelman School of Pharmacy and professor at the UNC School of Medicine and the UNC Gillings School of Global Public Health

Smarter Regulating

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.

Headshot of Ehsan Samei

Ehsan Samei, Ph.D
Reed and Martha Rice Distinguished Professor of Radiology at Duke University and chief imagining physicist for Duke University Health System

Innovation Mindset

There is no shortage of innovators working across our Triangle area research universities. As the newest CERSI, we can more directly partner with the FDA to apply our unique capabilities and strengths, such as the use of virtual twins, to ultimately speed and scale solutions toward making drugs, devices, the food supply, cosmetics and various other products more effective, safer and affordable.

Headshot of Christin Daniels

Christin Daniels, MA
Executive Director, Triangle CERSI

In the News

Eshelman Innovation

An Innovation Engine Evolves

Venture Studio

New Health Tech Platform to Help Fight the Opioid Crisis

Therapeutics

Eshelman Innovation Establishes Research Collaboration with Aston University

We value your privacy.

This website collects cookies to deliver a better user experience. By clicking “Accept”, you consent to our use of cookies.

Accept