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Pharmacogenetics to improve drug therapy

Award Number: R35GM131770
ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2019
PERIOD OF PERFORMANCE END DATE: 03/31/2025

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Pharmacogenetics to improve drug therapy - ABSTRACT The proposed research program will focus on two pharmacogenetic challenges that hold great potential for improving patient therapy. 1) The first challenge is to define the clinical importance of known pharmacogenetic associations, as related to drug toxicity and therapeutic failure—common outcomes of any therapy. The genetic contribution to variability in pharmacokinetics and pharmacodynamics, and thus potentially to differences in drug response, is well recognized. However, despite intensive research, little of this work has translated to clinical practice. A critical barrier is that the effect of genotype on meaningful patient outcomes in clinical practice is not known. Ideally, large randomized controlled trials would define the effect of genotype on clinical outcomes, and a few such studies are underway. However, given the expense of such trials, the many genotypes, drugs, and outcomes of interest, as well as the difficulties extrapolating from precise clinical trials to imprecise clinical practice, this approach is limited. Consequently, the path forward to translate science into practice is unclear. Accordingly, we propose a novel, cost effective approach: to use a de-identified electronic medical record (EHR) linked to a DNA biobank with >200,000 patients (BioVU) to define the clinical importance of variation in genes affecting drug metabolism or response. The long-term goal of this area of work is to develop and implement methods to define the importance of genetic variation on the outcomes of drug therapy in real world clinical practice. 2) The second challenge is to use genetics to predict unexpected toxicities and benefits of drugs. Over time, most drugs newly introduced to the market are found to have additional therapeutic indications and also unexpected toxicities. A critical barrier is that traditional post-marketing approaches to define these effects often require decades of study. During this time patients would accrue unwanted currently unknown adverse effects and forgo potential off-target benefits. Genetic approaches can provide information to speed this process. The mechanism of action of some drugs (e.g., ezetimibe that inhibits Nieman-Pick C1-like 1 (NPC1L1)) are mimicked by variations in genes (NPC1L1). By studying individuals who carry these variants and determining their outcomes in large EHR databases using a technique called phenome-wide association studies (PheWAS) followed by fine-phenotyping we can infer potential outcomes when patients are exposed to the drug. The long-term goal of this area of work is to develop and implement methods to use genetic information to discover unexpected benefits and risks of drugs. The two pharmacogenetic challenge areas that will be the foundation of the research program have high public health impact, not only in translating basic science to improved patient care for the drugs studied, but also in providing new approaches for testing the clinical importance of a range of drug/genotype questions.


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 = -$3,973 )
2025	2023	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Biomedical Research and Research Training	001	5	6/16/2025	NON-COMPETING CONTINUATION	-$3,973
2025	2023	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Biomedical Research and Research Training	000	5	11/5/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = -$3,973

Issue Date FY: 2023 ( Subtotal = $340,000 )
2023	2023	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Biomedical Research and Research Training	000	5	4/21/2023	NON-COMPETING CONTINUATION	$340,000
														Subtotal = $340,000

Issue Date FY: 2022 ( Subtotal = $340,000 )
2022	2022	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Biomedical Research and Research Training	000	4	3/29/2022	NON-COMPETING CONTINUATION	$305,998
2022	2022	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Biomedical Research and Research Training	001	4	6/22/2022	NON-COMPETING CONTINUATION	$34,002
														Subtotal = $340,000

Issue Date FY: 2021 ( Subtotal = $340,000 )
2021	2021	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Biomedical Research and Research Training	000	3	3/8/2021	NON-COMPETING CONTINUATION	$340,000
														Subtotal = $340,000

Issue Date FY: 2020 ( Subtotal = $340,000 )
2020	2020	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Biomedical Research and Research Training	000	2	3/23/2020	NON-COMPETING CONTINUATION	$340,000
														Subtotal = $340,000

Issue Date FY: 2019 ( Subtotal = $340,000 )
2019	2019	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Biomedical Research and Research Training	000	1	5/24/2019	NEW	$340,000
														Subtotal = $340,000

Grand Total All Awards = $1,696,028

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Pharmacogenetics to improve drug therapy

Award Number: R35GM131770

ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/01/2019

PERIOD OF PERFORMANCE END DATE: 03/31/2025

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