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Precision Medicine in the Acute Respiratory Distress Syndrome

Award Number: R35HL140026
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/16/2018
PERIOD OF PERFORMANCE END DATE: 03/31/2025

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Precision Medicine in the Acute Respiratory Distress Syndrome - ABSTRACT The acute respiratory distress syndrome (ARDS) is a common cause of respiratory failure in critically ill patients, with nearly 200,000 cases per year in the US alone and mortality rates of 30-40%. Clinical trials of novel pharmacotherapies in ARDS have met with nearly ubiquitous failure, a dismal track record which has been attributed at least in part to the considerable clinical and biological heterogeneity within this syndrome. With this strong evidence of significant clinical and biological heterogeneity and a major need for new therapies to improve poor clinical outcomes, ARDS is a ripe target for the application of precision medicine, yet little has been done to move from our current one-size-fits-all approach to ARDS clinical care and trials to a more targeted and personalized approach. We recently identified and validated the presence of two distinct subphenotypes (also known as “endotypes”) of ARDS in four large randomized controlled trials. In an independent analysis of all four datasets, there was strong evidence for two different endotypes within ARDS: a hyper-inflammatory endotype and a hypo-inflammatory endotype. These endotypes had strikingly different (1) clinical characteristics, (2) biomarker profiles, (3) clinical outcomes, and (4) treatment responses. Most notably, significant endotype- specific treatment responses were identified within three clinical trials previously thought to be “negative.” While these data are highly promising, we have only a basic understanding of the biology of these endotypes, of the full range of differential treatment responses they exhibit, of the impact of environmental exposures on endotypes, and of how best to translate this growing knowledge base into practical tools for application at the bedside and in clinical trials. In this application, we describe a research program that brings together expertise in molecular phenotyping of critical illness, environmental exposures assessment, advanced statistical approaches to analysis of complex multi-dimensional data, an experimental human lung model of ARDS, and access to clinical trial networks and diverse heterogeneous patient cohorts, in order to determine the optimal approach to applying precision therapeutics in human ARDS. This program has the potential to be paradigm-shifting by developing practical models for personalized medicine for patients with ARDS, targeted to the biology of an individual patient's disease, with a significant impact on both clinical trials and ultimately clinical care. In addition, these studies will have a high impact via identification of endotype-specific therapeutic responses in completed and ongoing ARDS clinical trials and by improving our understanding of the diverse biology of human ARDS, enhancing the likelihood that successful new therapeutics will be identified for each endotype. Finally, this program will develop a framework by which the principles of precision medicine can be applied to the fast-paced, rapidly evolving setting of critical care medicine.


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	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Lung Diseases Research	001	7	3/28/2025	NON-COMPETING CONTINUATION	$0
2025	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Lung Diseases Research	000	7	11/6/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $948,798 )
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	001	7	11/29/2023	NON-COMPETING CONTINUATION	$871,345
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Lung Diseases Research	002	7	6/12/2024	NON-COMPETING CONTINUATION	$77,453
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	6	10/30/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $948,798

Issue Date FY: 2023 ( Subtotal = $968,160 )
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	6	12/23/2022	NON-COMPETING CONTINUATION	$871,345
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	001	6	3/3/2023	NON-COMPETING CONTINUATION	$96,815
														Subtotal = $968,160

Issue Date FY: 2022 ( Subtotal = $967,250 )
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	001	5	6/13/2022	NON-COMPETING CONTINUATION	$96,725
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	5	1/21/2022	NON-COMPETING CONTINUATION	$870,525
														Subtotal = $967,250

Issue Date FY: 2021 ( Subtotal = $967,250 )
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	001	4	5/15/2021	NON-COMPETING CONTINUATION	$96,725
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	4	1/21/2021	NON-COMPETING CONTINUATION	$870,525
														Subtotal = $967,250

Issue Date FY: 2020 ( Subtotal = $965,311 )
2020	2020	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	001	3	3/13/2020	NON-COMPETING CONTINUATION	$48,267
2020	2020	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	3	12/16/2019	NON-COMPETING CONTINUATION	$917,044
														Subtotal = $965,311

Issue Date FY: 2019 ( Subtotal = $963,597 )
2019	2019	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	2	1/8/2019	NON-COMPETING CONTINUATION	$963,597
														Subtotal = $963,597

Issue Date FY: 2018 ( Subtotal = $986,596 )
2018	2018	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 420	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Lung Diseases Research	000	1	1/16/2018	NEW	$986,596
														Subtotal = $986,596

Grand Total All Awards = $6,766,962

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Precision Medicine in the Acute Respiratory Distress Syndrome

Award Number: R35HL140026

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/16/2018

PERIOD OF PERFORMANCE END DATE: 03/31/2025

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