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Herbal and Dietary Supplement Induced Liver Injury in the U.S.

Award Number: U01DK083027
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2008
PERIOD OF PERFORMANCE END DATE: 07/31/2028

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Herbal and Dietary Supplement Induced Liver Injury in the U.S. - PROJECT SUMMARY Einstein-Jefferson will continue to recruit cases for the three DILIN protocols; prospective, retrospective, and acute, and to participate in all of its procedures and ancillary studies. At Einstein-Jefferson, our main objective is to study liver injury due to Herbal and Dietary Supplements (HDS). Specifically, our approach will entail, through Aim 1, ongoing recruitment of patients with drug and supplement induced liver injury, with several alliances built to promote the enrollment of patients from under-represented minority (URM) groups. Such enhanced enrollment of URMs will not only expand access to our study but will also support our analyses. Related to this aim, we will validate for HDS induced liver injury (HILI) a recently published form of causality assessment; the RECAM. In aim 2, through the DILIN HDS repository housed at Einstein, we will continue to collect products from patients enrolled at all DILIN sites that have been implicated in liver injury for chemical analysis at the National Center for Natural Products Research (NCNPR). Related to this aim, we will work with the NCNPR to explore mechanisms of HILI, and also expand our collaboration on chemical analysis to include other organizations, such as the National Toxicology Program (NTP) and the Botanical Safety Consortium (BSC). The expanded collaboration (NCNPR, NTP, BSC) will allow us to develop new analytical techniques that will form the foundation for the design of human safety and therapeutic trials of multi-ingredient supplements. The critical innovation of our research is explained in aim 3, with the formation of a multi- stakeholder panel to conduct pharmacovigilance for HILI. This panel, comprising the DILIN group, FDA, CDC, and the NTP will focus on detecting case clusters of HILI. Detection of case clusters will, in turn, facilitate response to improve supplement safety through the FDA's regulatory actions, support the CDC's scientific investigations to prove the association of injury with a product, and support the development of better analytical techniques to detect injurious products through our collaboration with the NCNPR, NTP and the BSC. Related to this aim, our research will update our prior work which defined the incidence of drug and supplement induced liver injury in the State of DE, a state that is demographically similar to the U.S. This is an important study to provide context to the importance of HILI pharmacovigilance.


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 = $371,520 )
2024	2024	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST STE 1	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	18	8/30/2024	NON-COMPETING CONTINUATION	$371,520
2024	2023	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST STE 1	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	17	8/29/2024	COMPETING CONTINUATION	$0
2024	2023	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	17	1/31/2024	COMPETING CONTINUATION	$0
2024	2023	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST STE 1	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	17	8/5/2024	COMPETING CONTINUATION	$52,084
2024	2022	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	16	8/5/2024	NON-COMPETING CONTINUATION	-$52,084
														Subtotal = $371,520

Issue Date FY: 2023 ( Subtotal = $388,099 )
2023	2023	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	17	9/1/2023	COMPETING CONTINUATION	$388,099
														Subtotal = $388,099

Issue Date FY: 2022 ( Subtotal = $390,000 )
2022	2022	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	16	8/12/2022	NON-COMPETING CONTINUATION	$390,000
														Subtotal = $390,000

Issue Date FY: 2021 ( Subtotal = $400,000 )
2021	2021	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	8/17/2021	NON-COMPETING CONTINUATION	$400,000
														Subtotal = $400,000

Issue Date FY: 2020 ( Subtotal = $395,000 )
2020	2020	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	14	8/10/2020	NON-COMPETING CONTINUATION	$395,000
														Subtotal = $395,000

Issue Date FY: 2019 ( Subtotal = $298,291 )
2019	2019	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	13	8/13/2019	NON-COMPETING CONTINUATION	$298,291
2019	2018	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	12	12/3/2018	COMPETING CONTINUATION	$146,453
2019	2017	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	12/3/2018	NON-COMPETING CONTINUATION	-$146,453
														Subtotal = $298,291

Issue Date FY: 2018 ( Subtotal = $317,500 )
2018	2018	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	12	8/24/2018	COMPETING CONTINUATION	$317,500
2018	2017	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	11	3/13/2018	NON-COMPETING CONTINUATION	$0
2018	2017	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	3/9/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $317,500

Issue Date FY: 2017 ( Subtotal = $434,839 )
2017	2017	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	008	11	8/24/2017	NON-COMPETING CONTINUATION	$434,839
2017	2016	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	10	4/21/2017	EXTENSION WITH OR WITHOUT FUNDS	-$110,596
2017	2016	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	007	10	4/21/2017	EXTENSION WITH OR WITHOUT FUNDS	$31,154
2017	2016	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	006	10	4/21/2017	EXTENSION WITH OR WITHOUT FUNDS	-$31,154
2017	2016	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	10	11/29/2016	EXTENSION WITH OR WITHOUT FUNDS	$149,854
2017	2016	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	005	10	4/21/2017	EXTENSION WITH OR WITHOUT FUNDS	$110,596
2017	2015	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	11/29/2016	NON-COMPETING CONTINUATION	-$8,104
2017	2015	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	9	11/29/2016	SUPPLEMENT FOR EXPANSION	-$110,596
2017	2015	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK RD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	9	11/29/2016	SUPPLEMENT FOR EXPANSION	-$31,154
														Subtotal = $434,839

Issue Date FY: 2016 ( Subtotal = $491,046 )
2016	2016	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK ROAD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	8/3/2016	EXTENSION WITH OR WITHOUT FUNDS	$491,046
														Subtotal = $491,046

Issue Date FY: 2015 ( Subtotal = $484,814 )
2015	2015	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK ROAD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	8/25/2015	NON-COMPETING CONTINUATION	$343,064
2015	2015	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK ROAD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	9	8/27/2015	SUPPLEMENT FOR EXPANSION	$31,154
2015	2015	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK ROAD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	9	9/17/2015	SUPPLEMENT FOR EXPANSION	$110,596
														Subtotal = $484,814

Issue Date FY: 2014 ( Subtotal = $342,316 )
2014	2014	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK ROAD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	9/3/2014	NON-COMPETING CONTINUATION	$342,316
														Subtotal = $342,316

Issue Date FY: 2013 ( Subtotal = $340,779 )
2013	2013	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK ROAD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	7	9/2/2013	COMPETING CONTINUATION	$343,766
2013	2012	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	3/7/2013	NON-COMPETING CONTINUATION	-$171,982
2013	2012	ALBERT EINSTEIN HEALTHCARE NETWORK	5501 OLD YORK ROAD	PHILADELPHIA	PA	19141	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	3/11/2013	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$168,995
														Subtotal = $340,779

Issue Date FY: 2012 ( Subtotal = $245,126 )
2012	2012	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	5	8/23/2012	NON-COMPETING CONTINUATION	$245,126
2012	2010	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Trans-NIH Recovery Act Research Support	000	2	3/30/2012	SUPPLEMENT FOR EXPANSION	$0
2012	2009	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Trans-NIH Recovery Act Research Support	001	2	7/27/2012	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $245,126

Issue Date FY: 2011 ( Subtotal = $250,885 )
2011	2011	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	9/9/2011	NON-COMPETING CONTINUATION	$250,885
														Subtotal = $250,885

Grand Total All Awards = $6,255,217

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Herbal and Dietary Supplement Induced Liver Injury in the U.S.

Award Number: U01DK083027

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/30/2008

PERIOD OF PERFORMANCE END DATE: 07/31/2028

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