Sunday, October 6, 2024 10/6/2024

University of North Carolina Clinical Center for DILIN

Award Number: U01DK065201
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $368,806 )
2024	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	22	8/15/2024	NON-COMPETING CONTINUATION	$368,806
2024	2023	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	21	4/3/2024	COMPETING CONTINUATION	$0
2024	2023	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	21	8/14/2024	COMPETING CONTINUATION	$0
2024	2022	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	20	4/3/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $368,806

Issue Date FY: 2023 ( Subtotal = $398,587 )
2023	2023	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	21	9/1/2023	COMPETING CONTINUATION	$398,587
2023	2022	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	20	4/14/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $398,587

Issue Date FY: 2022 ( Subtotal = $349,335 )
2022	2022	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	20	8/11/2022	NON-COMPETING CONTINUATION	$349,335
2022	2021	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	19	6/23/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $349,335

Issue Date FY: 2021 ( Subtotal = $349,335 )
2021	2021	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	19	8/17/2021	NON-COMPETING CONTINUATION	$349,335
2021	2020	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	18	3/18/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $349,335

Issue Date FY: 2020 ( Subtotal = $349,338 )
2020	2020	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	18	8/10/2020	NON-COMPETING CONTINUATION	$349,338
														Subtotal = $349,338

Issue Date FY: 2019 ( Subtotal = $349,332 )
2019	2019	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	17	8/13/2019	NON-COMPETING CONTINUATION	$349,332
2019	2018	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	16	5/31/2019	COMPETING CONTINUATION	$108,082
2019	2017	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	5/31/2019	NON-COMPETING CONTINUATION	-$108,082
														Subtotal = $349,332

Issue Date FY: 2018 ( Subtotal = $302,420 )
2018	2018	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	16	8/24/2018	COMPETING CONTINUATION	$302,420
2018	2017	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	8/21/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $302,420

Issue Date FY: 2017 ( Subtotal = $386,930 )
2017	2017	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	15	8/24/2017	NON-COMPETING CONTINUATION	$386,930
2017	2016	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	14	11/10/2016	EXTENSION WITH OR WITHOUT FUNDS	$144,945
2017	2015	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	13	11/10/2016	NON-COMPETING CONTINUATION	-$144,945
														Subtotal = $386,930

Issue Date FY: 2016 ( Subtotal = $307,359 )
2016	2016	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	14	8/3/2016	EXTENSION WITH OR WITHOUT FUNDS	$307,359
														Subtotal = $307,359

Issue Date FY: 2015 ( Subtotal = $363,110 )
2015	2015	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	13	8/25/2015	NON-COMPETING CONTINUATION	$363,110
														Subtotal = $363,110

Issue Date FY: 2014 ( Subtotal = $258,218 )
2014	2014	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	12	9/3/2014	NON-COMPETING CONTINUATION	$258,218
														Subtotal = $258,218

Issue Date FY: 2013 ( Subtotal = $271,218 )
2013	2013	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	8/8/2013	COMPETING CONTINUATION	$271,218
														Subtotal = $271,218

Issue Date FY: 2012 ( Subtotal = $295,438 )
2012	2012	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	8/23/2012	NON-COMPETING CONTINUATION	$295,438
														Subtotal = $295,438

Issue Date FY: 2011 ( Subtotal = $315,971 )
2011	2011	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	9/9/2011	NON-COMPETING CONTINUATION	$315,971
														Subtotal = $315,971

Issue Date FY: 2010 ( Subtotal = $163,249 )
2010	2010	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	8/19/2010	NON-COMPETING CONTINUATION	$163,249
														Subtotal = $163,249

Issue Date FY: 2009 ( Subtotal = $201,082 )
2009	2009	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	7	9/4/2009	NON-COMPETING CONTINUATION	$201,082
2009	2008	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Digestive Diseases and Nutrition Research	001	6	11/18/2008	COMPETING CONTINUATION	$0
2009	2008	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Digestive Diseases and Nutrition Research	000	6	11/10/2008	COMPETING CONTINUATION	$0
														Subtotal = $201,082

Issue Date FY: 2008 ( Subtotal = $259,405 )
2008	2008	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Digestive Diseases and Nutrition Research	000	6	9/29/2008	COMPETING CONTINUATION	$259,405
														Subtotal = $259,405

Issue Date FY: 2007 ( Subtotal = $201,480 )
2007	2007	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	440 WEST FRANKLIN ST, CB #1350	CHAPEL HILL	NC	27599	ORANGE	USA	Digestive Diseases and Nutrition Research	000	5	9/17/2007	NON-COMPETING CONTINUATION	$201,480
														Subtotal = $201,480

Issue Date FY: 2006 ( Subtotal = $201,480 ) (Continued on the next page)
Grand Total All Awards = $6,349,261

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University of North Carolina Clinical Center for DILIN

Award Number: U01DK065201

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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