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Natural Product-Drug Interaction Research: The Roadmap to Best Practices

Award Number: U54AT008909
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2015
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Natural Product-Drug Interaction Research: The Roadmap to Best Practices - PROJECT SUMMARY OF THE OVERALL U54 CENTER Assessing the risk of adverse natural product (NP)-drug interactions (NPDIs) is of paramount importance due to the exponential NP sales growth in the US. This effort is challenged by relatively scant pharmacokinetic knowledge of individual NP constituents that precipitate these interactions and a lack of mechanistic understanding of NP effects on drug disposition. Investigations of NPDIs to address these knowledge gaps are complicated by the inherently large variability in phytoconstituent composition of supposedly the same NP, acquisition of sufficient high-quality NP study materials, and the diverse populations to which NPs are marketed, including the elderly. Our established Center of Excellence for Natural Product Drug Interaction Research (NaPDI Center) was created by the National Center for Complementary and Integrative Heath (NCCIH) in 2015 to address this public health problem. A cross-disciplinary research team composed of experts in clinical pharmacology, NP chemistry, biomedical informatics, and health communications led the charge to address the challenges unique to NPDI research. As detailed in this renewal application, we will advance the mission of the NaPDI Center by designing and executing new mechanistically-driven Interaction Projects, expanding the utility of our web-based data repository and public portal, and broadening dissemination of knowledge to national and international research communities. These activities will be accomplished through synergistic interactions between three established scientific Cores (Pharmacology, Analytical, and Informatics) and an overarching Administrative Core. The Pharmacology Core will expand an innovative method to select three to five high priority NPs to study as precipitants of potential clinically significant NPDIs. The Analytical Core will source and fully characterize the chemical composition of commercially available, representative NPs and provide NP study materials free of adulterants and contaminants for the Interaction Projects. The Pharmacology Core will design and execute rigorous in vitro studies to establish the mechanism of NP effects on drug disposition; predict the magnitude of NPDIs using physiologically-based pharmacokinetic modeling and simulation; and design and conduct clinical NPDI studies. The Analytical Core will provide quantitative analysis of object drugs, NP constituents, and emerging drug disposition biomarkers in the human pharmacokinetic samples. The interpreted data generated from the Interaction Projects will be transferred to the data repository developed and maintained by the Informatics Core. Major findings will be disseminated to scientific and other interested communities through our unique public access web portal perpetuated by the Informatics Core. All Cores will share the task of broadening Center outreach activities through targeted workshops and symposia at national and international scientific meetings. A Steering Committee composed of Core leaders and NCCIH officials will jointly oversee Center scientific progress with an External Advisory Panel of experts in relevant fields selected by NCCIH.


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: 2025 ( Subtotal = $0 )
2025	2024	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	001	10	8/8/2025	NON-COMPETING CONTINUATION	$0
2025	2024	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	000	10	7/22/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $2,094,143 )
2024	2024	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	001	10	8/27/2024	NON-COMPETING CONTINUATION	$2,094,143
2024	2023	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	000	9	4/17/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,094,143

Issue Date FY: 2023 ( Subtotal = $2,136,215 )
2023	2023	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	002	9	8/17/2023	NON-COMPETING CONTINUATION	$2,136,215
2023	2022	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	001	8	6/26/2023	NON-COMPETING CONTINUATION	$0
2023	2022	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	000	8	5/23/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,136,215

Issue Date FY: 2022 ( Subtotal = $2,176,368 )
2022	2022	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	002	8	9/14/2022	NON-COMPETING CONTINUATION	$2,176,368
2022	2021	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	000	7	10/27/2021	NON-COMPETING CONTINUATION	$0
2022	2021	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	001	7	3/23/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,176,368

Issue Date FY: 2021 ( Subtotal = $2,210,151 )
2021	2021	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	003	7	8/18/2021	NON-COMPETING CONTINUATION	$2,210,151
2021	2020	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	002	6	2/16/2021	COMPETING CONTINUATION	$0
2021	2020	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	001	6	2/9/2021	COMPETING CONTINUATION	$1,152,001
2021	2019	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	000	5	2/9/2021	NON-COMPETING CONTINUATION	-$1,152,001
														Subtotal = $2,210,151

Issue Date FY: 2020 ( Subtotal = $2,250,000 )
2020	2020	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	001	6	9/4/2020	COMPETING CONTINUATION	$2,250,000
2020	2019	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	000	5	3/13/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,250,000

Issue Date FY: 2019 ( Subtotal = $2,908,386 )
2019	2019	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	003	4	6/5/2019	SUPPLEMENT FOR EXPANSION	$158,967
2019	2019	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	004	5	8/29/2019	NON-COMPETING CONTINUATION	$2,464,888
2019	2018	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	002	4	12/27/2018	NON-COMPETING CONTINUATION	$328,738
2019	2018	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	000	4	10/29/2018	SUPPLEMENT FOR EXPANSION	$0
2019	2016	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	001	2	12/27/2018	NON-COMPETING CONTINUATION	-$44,207
														Subtotal = $2,908,386

Issue Date FY: 2018 ( Subtotal = $2,531,852 )
2018	2018	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	003	4	9/13/2018	SUPPLEMENT FOR EXPANSION	$888,473
2018	2018	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	000	3	1/4/2018	SUPPLEMENT FOR EXPANSION	$151,564
2018	2018	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	002	4	9/5/2018	NON-COMPETING CONTINUATION	$1,776,346
2018	2017	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	001	2	2/2/2018	SUPPLEMENT FOR EXPANSION	-$284,531
														Subtotal = $2,531,852

Issue Date FY: 2017 ( Subtotal = $2,116,766 )
2017	2017	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Research and Training in Complementary and Integrative Health	001	3	9/19/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,832,235
2017	2017	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	2	2/16/2017	SUPPLEMENT FOR EXPANSION	$284,531
														Subtotal = $2,116,766

Issue Date FY: 2016 ( Subtotal = $1,928,492 )
2016	2016	UNIVERSITY OF WASHINGTON	3917 UNIVERSITY WAY NE	SEATTLE	WA	98105	KING	USA	Research and Training in Complementary and Integrative Health	000	2	9/6/2016	NON-COMPETING CONTINUATION	$1,928,492
														Subtotal = $1,928,492

Issue Date FY: 2015 ( Subtotal = $2,015,154 )
2015	2015	UNIVERSITY OF WASHINGTON	3917 UNIVERSITY WAY NE	SEATTLE	WA	98105	KING	USA	Research and Training in Complementary and Integrative Health	000	1	9/1/2015	NEW	$2,015,154
														Subtotal = $2,015,154

Grand Total All Awards = $22,367,527

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Natural Product-Drug Interaction Research: The Roadmap to Best Practices

Award Number: U54AT008909

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2015

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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