# University of North Carolina Clinical Center for DILIN

> **NIH NIH U01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $368,806

## Abstract

Abstracts
Since the inception Drug-Induced Liver Injury Network (DILIN) in 2003, the University of North Carolina
Clinical Center have led all DILIN centers in total subject recruitment, participation in DILIN's subcommittees,
execution of ancillary studies, and authorship on DILIN publications. In the next 5 years, we propose to
continue our center's leadership as the network strives to attain the four stated goals of the RFA: 1. Advance
the clinical, biochemical, histologic and biologic characterization of DILI. We will continue to participate
in, or lead, all subcommittees, and the majority of ancillary studies and publications. We will expand our
access to minority patients through a new Community Health Care Network coordinated by an historically
black university. 2. Lead in the proposal and execution of ancillary studies and collaborations that
would investigate basic mechanisms of liver injury due to specific drugs and provide insights into
pathogenesis of DILI and potential targets for prevention and treatment. We will continue to support
DILIN's pioneering work on Genetic Risk Scores, their mechanistic insight, and their clinical application. We
will also guide discovery and application of promising non-genetic biomarkers through collaborations with the
major European biomarker initiative (Transbioline), the National Institutes for Environmental Health Sciences,
and potentially with a lead company in clinical application of metabolomics. 3. Develop pilot/feasibility
studies that would lay the groundwork for future studies on treatment of DILI. Our center is well
positioned to participate in a proposed open label pilot study of budesonide. 4. Promote pharmacovigilance
of HDS and newly approved prescription medications (collaboration with FDA) and public resources
for accurate information on DILI (DILIN centers and Livertox). We will help improve the new Revised
Electronic Causality Assessment Method (RECAM) instrument, including incorporation of genetic risk scores,
which should soon be adopted in assessment of clinical trial and early post-marketing DILI cases. We will
help mentor, along with FDA colleagues, an FDA supported ORISE fellow to improve prediction of liver injury
severity using traditional liver safety biomarkers. All four of our center's investigators will continue help build
and improve the Livertox website. In summary, we believe we are well poised to help guide the accelerated
rate of discovery and clinical application that will occur in the next 5 years and are very excited about it.

## Key facts

- **NIH application ID:** 10918224
- **Project number:** 5U01DK065201-22
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** PAUL B WATKINS
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $368,806
- **Award type:** 5
- **Project period:** 2003-09-30 → 2028-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10918224

## Citation

> US National Institutes of Health, RePORTER application 10918224, University of North Carolina Clinical Center for DILIN (5U01DK065201-22). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10918224. Licensed CC0.

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