Triangle CERSI is about synergy.
Together with the FDA, other CERSI centers, industry, academia, and the public, we advance regulatory science in design, practice, impact and public perception.
Our Consortium
The Triangle Center of Excellence in Regulatory Science and Innovation (Triangle CERSI) is a partnership between University of North Carolina at Chapel Hill (UNC-CH) and Duke University (Duke) and involves collaboration with North Carolina State University (NCSU), North Carolina Central University (NCCU), and the Burroughs Welcome Fund. This CERSI further leverages additional organizations and industry partners in centrally located Research Triangle Park, NC, to provide the CERSI network with complimentary expertise and infrastructure to help the FDA address the full spectrum of current and evolving needs in regulatory science.
Focus Areas
Technological Innovations to Evolve Regulatory Decision Making
The complexity and convergence of technologies and their applications have continued to accelerate, outpacing efforts to evaluate or optimize their design and use. For example, the emerging field of in silico trials—or computer simulations of how medical interventions interact with human anatomy, physiology, and pathological processes—represent a crucial advancement in regulatory science with transformative implications.
The ability to use digital twins as virtual study “participants” would signify a paradigm shift in how we assess the safety and efficacy of interventions. In partnership with the FDA, researchers at the Triangle CERSI address knowledge gaps in these emerging areas to help the agency adapt and innovate.
Solutions to Harness Data, Augment Quality and Modernize Clinical Trials
There is an imperative for novel, efficient, transparent, and validated methods to augment regulatory science. Those include the evaluation of autonomous AI, interpretability and transparency of AI methods, task-based quantification, and validating the accuracy and effective use of real-world evidence.
Triangle CERSI specializes in creating and testing new methods to find optimal treatment approaches and to identify groups of patients who are most likely to benefit—or experience harm—from therapies. Our specialization in Bayesian methods, causal inference, digital health, AI, and machine learning support improved regulatory decision making, particularly in rare diseases as well as cardiovascular, oncologic and pediatric trials.
Engaging with Patients, Consumers & Workforce to Understand Preferences, Perspectives and Differences
Achieving heterogeneity in clinical trial participants as well as among scientists, trainees and regulators is imperative to ensure unbiased healthcare outcomes. Studying patient-reported outcomes and engaging in community-based participatory research assures that patients and consumers are well-informed and share in decision-making.
Drug safety remains a key priority of regulatory science and understanding differences is crucial. A major strength of Triangle CERSI is expertise in pre- and post-marketing side effect assessment, defining mechanisms of racial differences in drug metabolism and susceptibility to drug-induced injury to inform risk. Proper dosing is another foundational topic, especially in pediatric patients. Supporting the FDA portfolio across the age spectrum, we bring unique resources and expertise to pediatric regulatory science.
Initiatives to Promote Health & Resiliency
Triangle CERSI unites four of the Triangle area research Universities, UNC Chapel Hill, Duke University, NC Central University and NC State University—as well as the vast network of clinical research organizations and biotech industries throughout the Research Triangle Park—to provide broad expertise and infrastructure for regulatory science collaborations with the FDA. Together, we address salient and novel topics related to health, wellness, and resiliency. Our capabilities in substance use disorders, emerging infectious diseases, antimicrobial resistance, food safety, and cross-cutting topics of public health importance will enhance the FDA’s understanding and assessment of risk and ensure continued safety and efficacy of products used by the public.
Technological Innovations to Evolve Regulatory Decision Making
The complexity and convergence of technologies and their applications have continued to accelerate, outpacing efforts to evaluate or optimize their design and use. For example, the emerging field of in silico trials—or computer simulations of how medical interventions interact with human anatomy, physiology, and pathological processes—represent a crucial advancement in regulatory science with transformative implications.
The ability to use digital twins as virtual study “participants” would signify a paradigm shift in how we assess the safety and efficacy of interventions. In partnership with the FDA, researchers at the Triangle CERSI address knowledge gaps in these emerging areas to help the agency adapt and innovate.
Solutions to Harness Data, Augment Quality and Modernize Clinical Trials
There is an imperative for novel, efficient, transparent, and validated methods to augment regulatory science. Those include the evaluation of autonomous AI, interpretability and transparency of AI methods, task-based quantification, and validating the accuracy and effective use of real-world evidence.
Triangle CERSI specializes in creating and testing new methods to find optimal treatment approaches and to identify groups of patients who are most likely to benefit—or experience harm—from therapies. Our specialization in Bayesian methods, causal inference, digital health, AI, and machine learning support improved regulatory decision making, particularly in rare diseases as well as cardiovascular, oncologic and pediatric trials.
Engaging with Patients, Consumers & Workforce to Understand Preferences, Perspectives and Differences
Achieving heterogeneity in clinical trial participants as well as among scientists, trainees and regulators is imperative to ensure unbiased healthcare outcomes. Studying patient-reported outcomes and engaging in community-based participatory research assures that patients and consumers are well-informed and share in decision-making.
Drug safety remains a key priority of regulatory science and understanding differences is crucial. A major strength of Triangle CERSI is expertise in pre- and post-marketing side effect assessment, defining mechanisms of racial differences in drug metabolism and susceptibility to drug-induced injury to inform risk. Proper dosing is another foundational topic, especially in pediatric patients. Supporting the FDA portfolio across the age spectrum, we bring unique resources and expertise to pediatric regulatory science.
Initiatives to Promote Health & Resiliency
Triangle CERSI unites four of the Triangle area research Universities, UNC Chapel Hill, Duke University, NC Central University and NC State University—as well as the vast network of clinical research organizations and biotech industries throughout the Research Triangle Park—to provide broad expertise and infrastructure for regulatory science collaborations with the FDA. Together, we address salient and novel topics related to health, wellness, and resiliency. Our capabilities in substance use disorders, emerging infectious diseases, antimicrobial resistance, food safety, and cross-cutting topics of public health importance will enhance the FDA’s understanding and assessment of risk and ensure continued safety and efficacy of products used by the public.
Leadership
Paul Watkins, MD
Principal Investigator, UNC
Director, Institute for Drug Safety Sciences; Howard Q. Ferguson Distinguished Professor of Pharmacy; Professor, UNC School of Medicine and UNC Gillings School of Global Public Health
Susan Halabi, PhD
Principal Investigator, Duke
James B. Duke Distinguished Professor; Professor of Biostatistics & Bioinformatics; Chief, Division of Biostatistics; Member of the Duke Cancer Institute
Robert Mentz, MD
Principal Investigator, Duke
Associate Professor of Medicine; Associate Professor in Population Health Sciences; Member in the Duke Clinical Research Institute
Ehsan Samei, PhD, DABR, FAAPM, FSPIE, FAIMBE, FIOMP, FACR
Principal Investigator, Duke
Reed and Martha Rice Distinguished Professor of Radiology; Professor in Radiology; Member of the Duke Cancer Institute; Professor of Biomedical Engineering; Professor in the Department of Electrical and Computer Engineering; Professor of Physics
Christin Daniels, MA
Executive Director
Jennifer Cavender, MPH
Project Manager
Anna Maria Caruso, MS
Grants Manager
The CERSI Network
There are currently five CERSIs. The institutions were selected and awarded through a competitive process for a cooperative agreement under RFA-FD-23-004. Renewal awards were made to University of Maryland, Johns Hopkins University, Yale University in joint effort with Mayo Clinic and University of California at San Francisco in a joint effort with Stanford University. The Triangle CERSI is the newest awarded and launched on September 1, 2023.
Want to learn more about Triangle CERSI?
Reach out to us through our Contact page to learn more about Triangle CERSI.