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 - Critical Illness Immunological Reprogramming and Control Point Learning Engine (CIRCLE)

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

Executive Summary:

The Advanced Research Projects Agency for Health (ARPA-H), Resilient Systems Office (RSO), has released an Innovative Solutions Opening (ISO) for the Critical Illness Immunological Reprogramming and Control Point Learning Engine (CIRCLE) (Solicitation Number: ARPA-H-SOL-26-139, Amendment 1).

CIRCLE seeks to reduce ICU stay length and improve outcomes by developing integrated systems that:

• Measure tissue-specific immuno-inflammatory biomarkers in near real time

• Build mechanistic, patient-specific computational “digital twin” models

• Modulate immune dysfunction using personalized therapeutic interventions

The program aims for a 25% reduction in average ICU stay length and progression toward FDA-compliant systems and clinical adoption.

Solution Summaries are due March 30th.

How much funding would I receive?

The solicitation states that multiple awards are anticipated.

• Awards will be made as Other Transaction (OT) agreements.

• The number of awards will depend on the quality of proposals and the availability of funds.

• Individual award amounts are not specified in the solicitation.

• Cost share requirements are not specified in the solicitation.

ARPA-H reserves the right to:

• Fund proposals in phases

• Segregate portions into pre-priced options

• Make partial awards

• Make no awards at all

What could I use the funding for?

Funding supports the integrated development of a Measure–Model–Modulate system for critical illness, including:

TA1 – Measurement

• Biomarker discovery and validation

• Tissue-specific immune monitoring technologies

• Data generation suitable for mechanistic modeling

TA2 – Modeling

• Mechanistic computational digital twin models

• In silico clinical trials

• FDA-compliant digital twin platforms

TA3 – Modulation

• Repurposing FDA-approved immunomodulatory therapies

• Development of novel immune-modulating approaches (if justified)

• Pre-clinical and clinical validation

Associate Performers (AP1, AP2, AP3)

• Data infrastructure and standards (AP1)

• Regulatory-compliant digital twin validation environment (AP2)

• ICU-realistic validation infrastructure and clinical trial support (AP3)

Projects must focus on immuno-inflammatory mechanisms common across critical illness and integrate into ICU workflows.

Are there any additional benefits I would receive?

CIRCLE performers will receive:

• Access to ARPA-H resources supporting regulatory approval

• Access to clinical trial consortia to accelerate FDA approvals

• Integration into a shared CIRCLE database that will ultimately become a public resource

• Structured cross-team collaboration across TAs and APs

• Government Purpose Rights (GPR) for certain deliverables

• Potential flexible IP treatment for commercially sensitive technologies (with approval)

Open-source development is highly encouraged using permissive licenses (e.g., CC-BY, BSD, MIT, Apache 2.0).

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

Key deadlines (Eastern Time):

• Proposers’ Day: Wednesday, March 11, 2026

• Solution summary submission: Monday, March 30, 2026, 1:00 PM

• Questions & Answers (Q&A) submission: Friday, May 22, 2026, 1:00 PM

• Proposal submission: Thursday, May 28, 2026, 1:00 PM

Deadlines will be strictly enforced.

Period of Performance

The program includes milestones extending up to 5 years from award date, including:

• 3 months: Coordination plans and metric establishment

• 6 months: Research plan finalization and approvals

• 1–3 years: Model development, calibration, validation

• 4–5 years: Integrated system validation and first-in-human adaptive platform trial

Funding timing after selection is not specified in the solicitation.

Where does this funding come from?

Funding comes from:

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

• Resilient Systems Office (RSO)

Solicitation Number: ARPA-H-SOL-26-139 (Amendment 1)

Awards will be issued as Other Transaction (OT) agreements.

Who is eligible to apply?

Eligible proposers include:

• Universities

• Non-profit organizations

• Small businesses

• Other than small businesses

FFRDCs and U.S. Government entities:

• May not respond as prime or sub-performers

• May engage with ARPA-H separately under specific conditions

Non-U.S. entities:

• May participate if compliant with applicable laws and regulations

• Awards will not be made to entities organized under the laws of a covered foreign country, foreign entities of concern (per CHIPS and Science Act), or individuals involved in a Malign Foreign Talent Recruitment Program.

All proposers must disclose Organizational Conflicts of Interest (OCI).

What companies and projects are likely to win?

Selectable proposals will:

• Directly address CIRCLE’s goals and objectives

• Integrate measurement, modeling, and modulation components

• Present realistic commercialization plans (for TA proposals)

• Demonstrate regulatory strategy and transition planning

• Provide strong interdisciplinary integration

• Include complete and realistic budgets

Proposals are evaluated individually (not comparatively) based solely on published evaluation criteria.

Budgets that are unrealistically high will be viewed unfavorably.

Are there any restrictions I should know about?

Key restrictions include:

• Funding cannot be used for human subjects research until all approvals are granted.

• Animal research requires IACUC approval prior to incurring costs.

• Performers must comply with federal human subjects and animal welfare regulations.

• Certain software and system components must be delivered with Government Purpose Rights.

• ARPA-H may impose publication restrictions if research involves sensitive information.

• All APIs must use open standards (e.g., REST, JSON, JSON-LD) unless otherwise approved.

• Existing data standards (e.g., HL7, FHIR, DICOM, LOINC, SNOMED CT) must be used where applicable.

Non-conforming proposals may be rejected without further review.

How long will it take me to prepare an application?

The solicitation warns that parts of the submission process may take from one business day to one month to complete.

Given the complexity of:

• Multi-TA integration

• Regulatory planning

• Data standards compliance

• Commercialization strategy

• Cross-team coordination

Companies should expect a significant preparation effort. The exact preparation time will depend on team readiness and prior integration planning.

How can BW&CO help?

BW&CO can support you by:

• Structuring your technical narrative around the Measure–Model–Modulate framework

• Stress-testing alignment with evaluation criteria

• Translating complex science into a fundable ARPA-H narrative

• Designing commercialization and transition strategies

• Supporting budget justification and value positioning

• Coordinating multi-institutional team structures

• Preparing for OT negotiation

CIRCLE is a systems-level, high-integration program. Positioning and coherence across TAs and AP interfaces will be critical.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements for submitting the Solution Summary ($7,500) available.

Additional Resources

Review the solicitation here.

NIDDK: Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes

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

Executive Summary:

NIH/NIDDK is seeking investigator teams to lead clinical trials testing digital health technologies in Type 2 Diabetes management. This R01 requires a clinical trial and aims to build evidence on how digital tools (e.g., continuous glucose monitors, mobile apps, telehealth, wearables) can improve glycemic and related outcomes in people with Type 2 Diabetes. Applications are due October 6, 2026 by 5:00 PM local time — plan ahead to prepare a full clinical trial proposal that adheres to NIH requirements.

How much funding would I receive?

Funds anticipated: Direct costs ~

• $1.5M in FY2026,

• $3.0M in FY2027-2030,

• $1.5M in FY2031.

Award budget: Not capped — must reflect actual needs of the proposed clinical trial project.

Project period: Up to 5 years.

What could I use the funding for?

General principles:

• Multimodality DHT interventions that for example, combine CGM concurrently with other digital interventions in a virtual remote continuous care intervention, though not required, are of particular interest to this NOFO.

• All investigators are expected to include meaningful engagement approaches with the relevant research population in designing and implementing the proposed trial. This may involve engagement with patients, family members or caregivers, community members, community-based organization, clinicians and other care providers, health care systems, or other relevant partners throughout the research process. Meaningful engagement must entail more than focus groups, surveys, or other activities where partners are only involved as participants or respondents. Engagement must be designed to ensure that the research is practical and aligns with partners' preferences and values. Meaningful collaboration will lead to optimal trial recruitment and conduct as well as potential for future dissemination and sustainability. 

• Multiple digital interventions have applicability to management of both T1 and T2 diabetes and these DHT interventions are of interest to this NOFO.

• Partnering with industry providers of virtual diabetes clinic offerings is allowed but not required.

• Clinical trials funded in response to this NOFO are expected to provide efficacy data that will enable future large multicenter clinical effectiveness studies on the application of DHT to PWD.

Examples of DHT interventions to be tested include, but are not limited to:

• Continuous glucose monitoring:

  • Studies on the efficacy of CGM in T2D, including in PWD not taking insulin

  • Studies on the utility of CGM in persons with prediabetes, for example, interventions that prevent the progression of prediabetes to diabetes

  • Studies examining the role of CGM in monitoring and adapting dietary interventions

  • Studies on the dose and duration of CGM usage necessary to effect change in health activation and healthy behaviors

  • Studies to assess and promote the accessibility, adoption and sustainability of CGM interventions

  • Studies assessing and improving the integration of CGM into clinic workflow, particularly in primary care settings

• Activity monitoring:

  • Studies examining the role of digital monitoring of activity on improvement of glycemia and other metabolic parameters in PWD

• Digital nutritional monitoring

  • The use of mobile applications to facilitate measures of macronutrient content of meals in PWD, and the impact of these interventions on diabetes-specific outcomes.

• Telemedicine, directed text messaging, patient portals, and peer-support

  • Studies assessing the incorporation of virtual communication into a multimodality virtual diabetes clinic model

  • Studies examining the influence of digital methods of multi-touchpoint peer support on glycemic and non-glycemic diabetes-specific outcomes

• Gaming and gamification

  • Studies examining the effect of digital gamification on the uptake and sustained adoption of diabetes education to improve knowledge and promote self-care behaviors (dietary, activity, and medication adherence) in a manner that improves diabetes-specific outcomes

• DHT adoption and sustainment

  • Studies examining factors predicting and improving patient engagement, adoption, and sustained use and utility of DHT interventions in PWD, and phenotyping according to acceptance of different modalities of DHT (CGM, wearables, telehealth, etc.) 

  • Studies examining the role of interventions to improve access of DHT for all PWD; to evaluate, measure, and improve digital literacy; and examine the influence of health beliefs and trust in the HCS on the successful utilization of all forms of DHT, including telemedicine 

  • Studies examining the influence of DHT interventions on patient engagement, self-empowerment, diabetes distress, and quality of life using validated measures.

  • Studies including a specific aim to determine the cost-effectiveness of specific DHT interventions in PWD 

  • Studies examining the effect of incentivizing PWD, providers and the health care system to incorporate DHT into diabetes management 

  • Studies examining the role of digital health navigators, including AI-based systems, in improving the acceptability and sustainability digital health interventions in PWD 

Are there any additional benefits I would receive?

• Potential to position your digital health intervention for future large multicenter effectiveness studies if early clinical evidence is strong.

• Grant support includes access to NIH peer review and scientific oversight.

Note: There’s no letter of intent required.

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

Posted Date: September 17, 2025

Application Due: October 6, 2026 by 5:00 PM local time

Where does this funding come from?

NIH — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the U.S. Department of Health and Human Services.

CFDA: 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research.

Who is eligible to apply?

Eligible domestic applicants include:

• Higher education institutions (public/private)

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

• For-profit organizations (including small businesses)

• Local and state governments

• Tribal governments/organizations

• Public housing authorities

• Independent school districts

• U.S. Federal agencies are eligible

Foreign organizations are NOT eligible.

What companies and projects are likely to win?

Strong proposals will have:

• A clearly defined clinical trial plan with measurable outcomes.

• Meaningful patient, provider, and community engagement integrated into design and implementation.

• Digital interventions that are ready for testing, not just conceptual.

• Evidence of feasibility and mechanism for adoption in real-world settings.

Are there any restrictions I should know about?

Not responsive:

• Projects developing new digital devices or algorithms.

• Studies focused on automated insulin delivery, artificial pancreas, or hybrid closed-loop tech.

• Research using DHT data only for subtyping/classification.

• Mechanistic trials that are not testing an intervention’s effectiveness.

How long will it take me to prepare an application?

Typical NIH R01 applications take several months to:

• Develop a rigorous clinical trial design,

• Form research team + collaborations,

• Draft research strategy + human subjects sections,

• Complete registrations (SAM, eRA Commons).

Most institutions begin 6-12 months before due date.

How can BW&CO help?

BW&CO can assist with:

• Translating this technical RFA into a clinical trial proposal roadmap.

• Crafting aims, hypotheses, and outcomes tables tailored to NIH review criteria.

• Aligning digital intervention strengths with NIH priorities.

• Supporting human subjects/clinical trial documentation and compliance.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements ($13,000 + 5%) available.

Additional Resources

Review the solicitation here.