Research triangle center of excellence in regulatory science and innovation

Active Cooperative Agreement Awarded Last action

Award ID
U01FD007857
Recipient
Awarding agency
Obligated
$31,056,379

Award facts

Assistance listing
93.103 Food and Drug Administration Research
Completion date 91% complete
Funding agency
Office of the Commissioner Food and Drug Administration, Department of Health and Human Services
Place of performance
Chapel Hill, NC 27599, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
The rapid emergence of innovative technologies, therapeutics, and other FDA-regulated products have outpaced the ability to effectively appropriate them for public benefit. Doing so hinges on the capability to expeditiously evaluate these products and effectively monitor them once on the market. However, methodologies for pre- market evaluation through laboratory testing and clinical trials for drugs, devices, and biologics and for post- marketing surveillance of all FDA-regulated products have not kept pace, and key gaps in knowledge exist that would inform regulatory decision making in many areas. In the face of these pressing needs, the research triangle center of excellence in regulatory science and innovation (triangle cersi) will provide a one-stop- shop accelerator to meet FDA's current and evolving needs in regulatory science and a generative community for regulators, academia, industry, and other stakeholders. A collaboration of the university of north carolina at chapel hill, duke university, north carolina state university, and north carolina central university, all in close proximity, the triangle cersi represents a broad network of investigators and national and international collaborators that bring unique and diverse expertise and resources for regulatory science, including but not limited to novel approaches in statistical methodologies, machine learning and artificial intelligence, imaging, in silico trials, pediatric pharmacology, patient reported outcomes (pro), population science, and safety assessment across the lifespan, and other areas. The triangle cersi includes two schools of medicine, a school of pharmacy, two schools of nursing, a school of public health, a college of veterinary medicine, a leading historically black university, a national center for virtual imaging trials, and the duke clinical research institute, and leverages relationships with nearby companies and organizations in the research triangle park. The triangle cersi has three specific aims: 1. Conduct regulatory science projects in collaboration with FDA to deliver major advances in regulatory science and rapidly address a broad range of major, specific, and emerging challenges in response to FDA needs. 2. Establish robust cersi core infrastructure to develop, propose, support, enable, and monitor execution of cersi research projects to facilitate rapid achievement of project deliverables; partner OAK ridge national laboratory provides support for data access, computation, and resource sharing. 3. Expand support of the triangle cersi and extend its impact through regulatory science information sharing activities, including efforts to diversify the regulatory science workforce. The triangle cersi will actively share results and newly developed tools and resources with the FDA, research community, stakeholders, and our institutions' students and trainees. Together, our overarching goal is 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 cersis and contribute to achieving the goals of the national cersi program.

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Subawards

Subrecipient Amount Awarded
University Of Alabama At Birmingham The project aims to develop estimands, analysis methods, visualization techniques, and sensitivity analysis tools within a principal stratification framework… $87,402
North Carolina Central University Opioids account for nearly 75% of U.S. overdose deaths, with the epidemic costing an estimated $1.5 trillion. Among 2.7 million adults with Opoid Use Disorder… $51,723
Duke University Clinical trials assessing oral inhibitors of IDH1 and IDH2 have demonstrated efficacy in IDHmutated acute myeloid leukemia, but racial-ethnic minority groups… $148,724
Duke University The project aims to develop comprehensive educational modules that provide learners with an overview of the Roadmap to Patient-Focused Outcome Measurement in… $1,321,444
The University Of Kentucky Research Foundation The University of Kentucky research team will contribute their expertise to coordinate all the project activities and meet the aims of the study: Aim 1 -… $349,461
Duke University The Duke University investigator will be responsible for: * Overseeing and leading the team research to conduct all of the proposed research; * Guide the PhD… $579,675
Duke University The goal of this project is to identify the influence of recall periods on measurement of patient-reported symptoms and function for episodic… $156,147
Duke University The Duke University leadership team will be responsible for the timely and compliant conduct of the CERSI, collaboration with the US FDA to identify, develop,… $725,346
Digital Medicine Society Inc. This research will test the hypothesis that identifying the behavioral aspects of relapse in OUD can inform the development of protocols for the development and… $1,294,086
Duke University The Duke CERSI team will perform a systematic literature review to synthesize findings from existing qualitative research pertaining to behavioral aspects of… $568,063

Quick answers

Who received award U01FD007857?

U01FD007857 was awarded to University Of North Carolina At Chapel Hill by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 1, 2023.

How much is award U01FD007857 worth?

$31,056,379 has been obligated on U01FD007857.

Which agency awarded U01FD007857?

FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded U01FD007857, with funding from Office of the Commissioner (Food and Drug Administration).

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