PAR-26-040: Advancing Bioinformatics, Translational Bioinformatics and Computational Biology Research (R01 Clinical Trial Optional)

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

PAR-26-040 invites research teams to lead transformational advances in bioinformatics, translational bioinformatics, and computational biology. This opportunity from the National Library of Medicine (NLM) supports projects that create cutting-edge methods, tools, and computational approaches for extracting actionable knowledge from complex biological and biomedical data. Applications open April 6, 2026 and follow NIH standard due dates (first due June 5, 2026). This initiative supports scalable, generalizable innovations that accelerate biomedical discovery and improve health outcomes.

How much funding would I receive?

• Direct cost limit: Up to $250,000 per year (applicants must justify budget based on project needs).

• Anticipated total program funding: Approximately $2,500,000.

• Estimated number of awards: 10.

What could I use the funding for?

Fund research projects that:

• Develop new computational methods and tools for bioinformatics and biomedical data science.

• Leverage AI, machine learning, and large-scale computation to interpret diverse biological datasets.

• Produce durable, generalizable artifacts (software, workflows, resources) that benefit the wider research community.

• Enable translational insights with potential impact on health outcomes.

Excluded: incremental tweaks to existing tools, projects outside core bioinformatics/computational biology focus, social/ethical studies unrelated to computational method advancement.

Are there any additional benefits I would receive?

• Projects are expected to produce open science outputs (e.g., FAIR tools, publicly available code, datasets).

• Participation in NIH peer review and community of biomedical informatics researchers.

What is the timeline to apply and when would I receive funding?

• Standard NIH due dates: June 5, October 5, February 5 recurring through 2029 (all due by 5:00 PM local time of the applicant).

• NOFO expiration date: March 6, 2029.

• Earliest possible project start: July 2026.

Where does this funding come from?

This opportunity is funded by the U.S. Department of Health and Human Services (HHS) through the National Institutes of Health (NIH), specifically the National Library of Medicine (NLM).

Who is eligible to apply?

Eligible applicants include:

• Higher education institutions (public and private).

• Nonprofits (with or without 501(c)(3) status).

• For-profit organizations, including small businesses.

• Local and state governments.

• Tribal governments and organizations.

• Foreign organizations (subject to NIH policies).

Important NIH policy: NIH will not issue awards for applications that include foreign subawards or subcontracts unless submitted to a NOFO specifically for international collaborations.

What companies and projects are likely to win?

Competitive applications will:

• Demonstrate high innovation and impact in computational biology/bioinformatics.

• Deliver tools and methods that are publicly accessible and broadly usable.

• Show rigorous validation and clear plans for dissemination.

• Integrate interdisciplinary approaches and emphasize scalability.

Are there any restrictions I should know about?

• Foreign subawards/subcontracts are not allowed (projects with those elements will be noncompliant).

• Cost sharing/matching is not required.

• The project must align with NLM’s focus areas; non-responsive or tangential projects will not be reviewed.

How long will it take me to prepare an application?

Preparation time varies by complexity, but obtaining organizational registrations (SAM, eRA Commons) alone can take several weeks. Technical application drafting with rigorous computational research plans, data management strategy, and dissemination plans typically requires multiple months of coordinated effort.

How can BW&CO help?

BW&CO can:

• Translate scientific aims into NIH-aligned application narratives.

• Help articulate innovation, significance, and approach clearly.

• Build budget justification and milestone plans that meet NIH expectations.

• Develop data management, dissemination, and impact strategies that strengthen score.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements for submitting application ($13,000) available.

Additional Resources

Review the solicitation here.

PAR-26-042: Research Grants in Clinical Informatics (R01 Clinical Trial Optional)

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

This funding opportunity from the National Library of Medicine (NLM) at NIH supports investigator-initiated research grants in clinical informatics that develop innovative, generalizable methods and tools to transform complex health data into actionable knowledge and improve decision-making and health outcomes. Applications must be submitted by 5:00 PM local time on one of the standard NIH due dates (next dates include June 5, 2026; October 5, 2026; February 5, 2027, etc.) and the NOFO remains active until its expiration on March 6, 2029.

How much funding would I receive?

• Direct cost limit: Up to $250,000 per year (applicants must justify budget based on project needs).

• Anticipated total program funding: Approximately $2,500,000.

• Estimated number of awards: 10.

What could I use the funding for?

Fund research focused on the design, implementation, and evaluation of clinical informatics tools and methods that:

• Enable data-driven discovery and evidence-based decision-making.

• Transform raw, heterogeneous health data (e.g., EHRs, clinical notes, imaging, patient-generated data) into usable knowledge.

• Produce scalable, reproducible, domain-independent approaches broadly applicable across clinical settings.

• Improve clinical workflows, predictive analytics, decision support, interoperability, and precision health.

Are there any additional benefits I would receive?

• Potential to accelerate scientific insights and inform future research beyond the project period.

• Alignment with NLM’s mission to advance data-driven biomedical research and healthcare.

• Software, datasets, methods, and resources are expected to be disseminated widely to maximize impact.

What is the timeline to apply and when would I receive funding?

• Standard NIH due dates: June 5, October 5, February 5 recurring through 2029 (all due by 5:00 PM local time of the applicant).

• NOFO expiration date: March 6, 2029.

• Earliest possible project start: July 2026.

Where does this funding come from?

This opportunity is funded by the U.S. Department of Health and Human Services (HHS) through the National Institutes of Health (NIH), specifically the National Library of Medicine (NLM).

Who is eligible to apply?

Eligible applicants include:

• Higher education institutions (public and private).

• Nonprofits (with or without 501(c)(3) status).

• For-profit organizations, including small businesses.

• Local and state governments.

• Tribal governments and organizations.

• Foreign organizations (subject to NIH policies).

Important NIH policy: NIH will not issue awards for applications that include foreign subawards or subcontracts unless submitted to a NOFO specifically for international collaborations.

What companies and projects are likely to win?

Competitive applications will:

• Address transformative clinical informatics challenges and align tightly with NLM goals.

• Demonstrate innovation, scalability, and generalizability beyond narrow disease-specific problems.

• Provide clear plans for evaluation, dissemination, and sustainability of tools and methods.

• Present metrics for impact and comparison to existing approaches.

Are there any restrictions I should know about?

• Projects must be clearly focused on clinical informatics and not be incremental improvements of existing tools.

• Projects primarily focused on social determinants of health or ethical/legal/social issues are considered non-responsive.

• Applications with foreign subawards/subcontracts are noncompliant and will not be reviewed.

How long will it take me to prepare an application?

Preparation time depends on your readiness, but NIH typically recommends starting months before the nearest due date to:

• Complete registrations (Grants.gov, eRA Commons, SAM/NCAGE, UEI).

• Develop a rigorous research plan with evaluation and dissemination strategies.

• Coordinate any institutional approvals.

Begin ASAP to ensure you meet the due date’s 5:00 PM local time deadline.

How can BW&CO help?

BW&CO can:

• Translate scientific aims into NIH-aligned application narratives.

• Help articulate innovation, significance, and approach clearly.

• Build budget justification and milestone plans that meet NIH expectations.

• Develop data management, dissemination, and impact strategies that strengthen score.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements for submitting application ($13,000) available.

Additional Resources

Review the solicitation here.

ARPA-H SSO: “AGENTIC AI-ENABLED CARDIOVASCULAR CARE TRANSFORMATION” (ADVOCATE)

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

ARPA-H is now accepting proposals for ADVOCATE: Agentic AI-Enabled Cardiovascular Care Transformation, a major new Innovative Solutions Opening (ISO) focused on deploying autonomous, FDA-regulated clinical AI agents for cardiovascular disease (CVD) care at national scale.

This program is designed to fund teams that can build, validate, and deploy patient-facing AI agents, paired with independent supervisory AI, and integrate them directly into real healthcare systems. Selected performers will work closely with FDA, large health systems, and ARPA-H leadership to establish a blueprint for scalable, reimbursable agentic AI in healthcare. A Solution Summary is mandatory and is due February 27, 2026, at 5:00 PM EST. Full proposals are by invitation only and are due April 1, 2026, at 5:00 PM EST.

How much funding would I receive?

• Total award size: Not specified in the solicitation

• Number of awards: Multiple awards anticipated

• Funding mechanism: Other Transaction (OT) Agreements

• Program length: Up to 39 months

  • Phase 1A: 12 months

  • Phase 1B: 12 months (option)

  • Phase 2: 15 months (option)

What could I use the funding for?

Funding must support development, validation, and deployment of agentic AI systems for cardiovascular care, aligned to one or more of the following Technical Areas (TAs):

TA1 — CVD Agent (Patient-Facing Clinical AI)

• Autonomous or semi-autonomous AI agents that:

  • Provide diagnostic and treatment assistance

  • Adjust prescriptions for CV conditions (FDA medical device)

  • Integrate real-time EHR and wearable data

  • Deliver 24/7 outpatient care management

• Clinical reasoning using multimodal inputs (text, voice, image, video)

• FDA regulatory engagement and authorization

• Deployment into real health systems for scalability studies

TA2 — Supervisory Agent (AI Oversight & Control)

• Disease-agnostic AI that:

  • Monitors safety, accuracy, uncertainty, and risk of clinical AI

  • Enables real-time control and auditability

  • Supports FDA Medical Device Development Tool (MDDT) qualification

• Continuous post-market monitoring functionality

• Strong preference for open-source solutions

TA3 — Scaled Implementation (Health Systems Only)

• Integration of TA1 and TA2 agents into live clinical workflows

• Access to EHR production and pre-production environments

• Execution of large-scale Scalability Studies

• Clinical outcome, cost, and reimbursement evidence generation

Are there any additional benefits I would receive?

Selected teams receive:

• Direct engagement with FDA throughout development

• Access to real EHR data, clinicians, and patients (via TA3 performers)

• Participation in large, ARPA-H-funded scalability studies

• Validation by an independent IV&V partner

• Visibility with payers and CMS-relevant evidence generation

• Potential facilitation of investor engagement by ARPA-H

What is the timeline to apply and when would I receive funding?

Key dates (firm):

• Posting date: January 13, 2026

• Proposers’ Day: January 23, 2026 (8:30 AM – 5:00 PM EST)

• Proposers’ Day registration deadline:

  • In-person: January 21, 2026, at 5:00 PM EST

  • Virtual: January 21, 2026, at 5:00 PM EST

• Solution Summary due: February 27, 2026, at 5:00 PM EST

• Full proposal due (if invited): April 1, 2026, at 5:00 PM EST

Funding timing after submission is not specified and is contingent on negotiations and down-selection decisions.

Where does this funding come from?

• Agency: Advanced Research Projects Agency for Health (ARPA-H)

• Office: Scalable Solutions Office (SSO)

• Authority: Other Transaction (OT)

Who is eligible to apply?

Eligible applicants include:

• U.S. startups and growth-stage companies

• Universities and academic teams

• Non-profit organizations

• Non-federal research organizations

Not eligible:

• Federally Funded Research and Development Centers (FFRDCs)

• Federal government entities or employees (as performers)

• Entities from covered foreign countries or foreign entities of concern

• Organizations with unmitigable ARPA-H conflicts of interest

TA3 applicants cannot apply to TA1 or TA2.

What companies and projects are likely to win?

ARPA-H is explicitly seeking teams that:

• Are building agentic (not rules-based) clinical AI

• Can meet FDA medical device or MDDT requirements

• Have real experience integrating with EHRs and health systems

• Can demonstrate a path to non-inferiority vs cardiologists

• Are prepared for open data sharing and multi-party collaboration

• Can scale beyond pilots into national deployment

Incremental clinical decision support tools are unlikely to be competitive.

Are there any restrictions I should know about?

Key restrictions include:

• Foundation models cannot be developed from scratch

• Solutions must be interoperable with other agents

• Clinical AI must pursue FDA authorization or qualification

• Extensive data-sharing and collaboration are mandatory

• Foreign talent, ownership, or funding risks are heavily scrutinized

• TA1 and TA2 proposals must remain technically independent

How long will it take me to prepare an application?

• Solution Summary: ~2–4 weeks for competitive teams

• Full Proposal: ~6–10 weeks if invited

Team formation, regulatory strategy, and data architecture must be addressed early.

How can BW&CO help?

BW&CO helps teams:

• Translate ADVOCATE requirements into a clear, fundable narrative

• Position technical capabilities against TA-specific metrics

• Shape FDA and commercialization strategy language

• Design compliant multi-party teaming structures

• Avoid common ARPA-H disqualifiers

How much would BW&CO Charge?

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

Review the solicitation here.