Attachment 1 MVP 2025 Industry Partnership RFI_Heart Failure RFI 2.pdf

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AJ11--36C24E-24-AP-1087 | RFI for Industry Partnership with MVP in heart failure See attached RFI and instructions.
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36C24E24Q0136
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This document is a Request for Information (RFI) issued by the Million Veteran Program (MVP), a national research program under the Department of Veterans Affairs (VA), to survey responses that may further advance translational research in heart failure using MVP data.

The RFI provides background on the MVP program, its objectives, and the available data, which includes electronic health records, self-reported surveys, genomic data, and other approved sources. The research scope focuses on using MVP data and VA investigators' expertise to aid industry partners in areas such as generating genetic evidence for drugs in the pipeline for heart failure, identifying and validating targets for repurposing drugs or novel drug development, identifying patient populations likely to benefit from potential clinical trials, and developing or validating biomarkers.

The RFI requires that industry partners and project staff be located in the United States and that respondents complete an attached intake form. The VA will treat any response to this RFI as source selection sensitive information and will protect confidentiality accordingly. This RFI is for information and planning purposes only and is not a commitment by the government to engage in any future contract or agreement.

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Attachment 2 MVP 2025 Industry Partnership Intake Form.pdf PDF

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BACKGROUND

The Million Veteran Program (MVP) is a national research program designed to advance precision health care by learning how genes, lifestyle, military experiences, and exposures affect health and wellness. MVP is the nation’s largest biorepository of Veteran data with more than 1,000,000 Veterans enrolled and has one of the world’s most diverse cohorts of any genetic research program. A strength of MVP is in the diversity of participants, which includes 25% from racial minority backgrounds, of which 18% are of African ancestry. Additionally, Hispanic Veterans represent 8% of participants and women Veterans make up 10% of the cohort. To date, more than 700 researchers have used MVP data resulting in in 400+ publications.

PURPOSE:

The MVP is issuing this Request for Information (“RFI”) to survey responses which may further advance translational research in heart failure with MVP data. Information collected from this RFI will serve as continued market research for the potential future solicitation and development of a Collaborative Research and Development Agreement (CRADA) with an industry partner(s).

Such an agreement will detail the resources to be provided by the VA and the Industry partner and describe the purpose and expected work to be accomplished between the MVP research team and industry to study Heart Failure and its clinical subtypes. MVP VA researchers will leverage MVP resources to aid the industry partner(s) in their research and development of treatments, diagnostics, biomarkers, and other health initiatives for heart failure and its clinical subtypes.

DESCRIPTION OF DATA: MVP data includes electronic health record data, MVP self-reported surveys, MVP genomic data, and data from other approved data sources on MVP participants. Access to individual level coded MVP data is limited to VA researchers and provided within the MVP secure computing environment, in accordance with VA regulatory approvals.

For other important information and tools used for MVP please visit:

1. mvp.va.gov

a. MVP background and objectives

b. MVP_Publications_2024_06.pdf (va.gov)www.research.va.gov/programs/cipher/

2. CIPHER - VA (ornl.gov) Developed by the U.S. Department of Veterans Affairs (VA), CIPHER is an online knowledge-sharing platform that aims to optimize electronic health records (EHR) data for use in research and clinical operations. CIPHER catalogs phenotypes based on algorithm components, data source(s), method, programming language, context of development, and validation metrics. What initially began as a collective effort to drive collaboration and innovation within the largest healthcare system in the United States is now available as a public resource.

RESEARCH SCOPE:

Heart failure is a global epidemic affecting 64 million individuals worldwide and 6 million in the US, including 5% of US Veterans costing roughly $6.6 billion dollars globally. This condition has a high morbidity, mortality, and cost of care to each patient which in turns burdens the already strained healthcare system. To better understand and characterize the genetic and phenotypic http://www.research.va.gov/programs/cipher/ https://phenomics.va.ornl.gov/web/ indicators to treat heart failure, the VA has employed some of the foremost experts, who have conducted extensive research using MVP data.1,2 The goal of this collaboration between the VA and industry partner(s) is to utilize MVP data and VA investigators’ expertise to better aid the industry partner(s) on novel discovery in heart failure and its clinical subtypes that can be used but not limited to:

1. Generate genetic evidence for drugs in pipeline for heart failure

2. Identify and validate targets for repurposing drugs in pipeline

3. Identify and validate novel drug targets for development

4. Identify patient populations likely to derive maximum benefit to be used in preparation for future or potential clinical trials

5. Develop or validate biomarkers

REQUIREMENTS:

• Industry partner and project staff shall be located in the United States

• Complete the attached Intake form

HOW TO REPOND TO NOTIFICATION:

Email Intake form and attachments to MVPPartnerships@va.gov and the Contracting Officer michael.haydo@va.gov

NOTES:

MVP will not return or provide feedback on any submissions, but MVP does reserve the right to further engage with respondents to clarify understanding of submitted content.

MVP will treat any response to this RFI as source selection sensitive information and will protect confidentiality accordingly.

This notice is for information and planning purposes only and is not to be construed as a commitment by the Government nor will the Government pay for information solicited.

Respondents may be notified of the results of the evaluation.

REFERENCES:

1 Joseph, J., Liu, C., Hui, Q. et al. Genetic architecture of heart failure with preserved versus reduced ejection fraction. Nat Commun 13, 7753 (2022). https://doi.org/10.1038/ s41467-022-35323-0 2 Rasooly, D.,…...Joseph, J., Casas, J.P. Genome-wide association analysis and Mendelian randomization proteomics identify drug targets for heart failure. Nat Commun 14, 3826 (2023).

https://doi.org/10.1038/s41467-023-39253-3 mailto:MVPPartnerships@va.gov https://doi.org/10.1038/s41467-022-35323-0 https://doi.org/10.1038/s41467-022-35323-0 https://doi.org/10.1038/s41467-023-39253-3

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