Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Not Allowed)

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

Executive Summary:

This NIH funding opportunity (PAR-25-338) opens a repeated standard R01 grant mechanism to support academic-industrial partnerships that translate scientific discoveries and engineering developments into new technologies, methods, tools, assays, devices, or systems relevant to disease diagnosis, risk assessment, detection, prevention, treatment, or monitoring — with the expectation of translation to use and end users. This NOFO does not allow clinical trials and does not support basic research that lacks a translational component. Multiple standard NIH due dates run through January 8, 2028 (expiration), with recurring application windows (e.g., Feb 5, 2026; Jun 5, 2026; Oct 5, 2026, etc.) — all due by 5:00 PM local time on each date.

How much funding would I receive?

Award budget limit: up to $499,000 per year in direct costs.

1. Maximum project period: 5 years.

2. Number of awards: contingent on NIH appropriations and meritorious applications (not specified).

What could I use the funding for?

Funds may be used to enhance, adapt, optimize, validate, and otherwise translate technologies, methods, assays, devices, or systems that:

• Address problems in biology, pathology, risk-assessment, detection, diagnosis, treatment, or monitoring disease.

• Advance capabilities that are suitable for end users in pre-clinical or clinical research or clinical care.

• Examples include diagnostic/imaging systems, informatics tools, analytical methods, harmonized data methods, shared research resources, and technologies optimized for low-resource settings.

Are there any additional benefits I would receive?

The NOFO does not include special supplements, set-aside support, or technical assistance beyond standard NIH funding. (Not specified in the NOFO.)

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

• Open/earliest submission: January 5, 2025.

• Standard NIH due dates: recurring submission windows including Feb 5, Jun 5, Oct 5 of each calendar year, through January 8, 2028 (expiration). All are due by 5:00 PM local time.

• Applicants should allow time to correct any errors before each deadline.

• Estimated award start dates follow NIH standard review cycles (months after each review).

Where does this funding come from?

• Funding agency: National Institutes of Health (NIH), U.S. Department of Health and Human Services.

• Participating NIH components:

  • National Cancer Institute (NCI)

  • National Eye Institute (NEI)

  • National Institute of Dental and Craniofacial Research (NIDCR)

  • Office of Research on Women’s Health (co-funding support)

Who is eligible to apply?

Eligible applicant organizations include:

• Higher education institutions (public/private).

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

• For-profit organizations (including small businesses).

• Local/state governments; federally recognized tribal governments.

• Federal agencies; non-U.S. entities (foreign) and foreign components of U.S. organizations.

Eligible individuals: Anyone with the skills/resources to carry out the proposed research as PD/PI.

What companies and projects are likely to win?

Likely competitive projects will:

• Form true academic-industrial partnerships with complementary expertise.

• Target translation of a technology/method toward a defined end-user application.

• Demonstrate a coherent plan to enhance, optimize, validate, or translate the proposed technology.

• Show clear metrics, milestones, and feasibility for implementation or adoption.

• Address problems relevant to participating NIH institutes.

Are there any restrictions I should know about?

• Clinical Trials: Not allowed under this NOFO.

• Commercial production: NOT supported; the grant supports translation up to pre-commercial readiness, not manufacturing.

• Basic research: Projects lacking translation emphasis are non-responsive.

• Applications must conform to NIH research and submission policies (e.g., DMS, registrations).

How long will it take me to prepare an application?

Time depends on readiness of data, partnerships, and NIH registrations (e.g., SAM, eRA Commons). Typical R01 applications require weeks to months of preparation, including:

• Strategic alliance planning

• Preliminary data assembly

• Detailed research strategy

• Budget and justification

• Registrations (SAM/eRA Commons) prior to submission (can take ~6+ weeks).

How can BW&CO help?

BW&CO can:

• Clarify partner roles and narrative strategy for academic-industrial teams.

• Translate technical aims into NIH-aligned specific aims and research strategy.

• Advise on regulatory, translational, and commercialization framing.

• Support budget planning consistent with NIH guidelines.

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.

DIU: AI Assisted Triage & Treatment Challenge

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

Executive Summary:

The AI Assisted Triage & Treatment Challenge is a Defense Innovation Unit (DIU) prize challenge seeking portable, network-capable hemodynamic monitoring systems for forward combat medical environments. The goal is to enable real-time triage and predictive warning of dangerous physiological conditions in austere and Denied, Disrupted, Intermittent, and Limited (DDIL) settings.

Up to eight (8) finalists will share a $999,000 total prize pool and demonstrate at Sword 2026. Top performers may be invited to pursue a Prototype Other Transaction (OT) under 10 U.S.C. § 4022 without further competition.

Responses Due By: 2026-03-02 23:59:59 US/Eastern Time.

How much funding would I receive?

• $999,000 total prize pool, split among up to eight (8) finalist companies.

• Exact distribution per company is not specified.

• DIU has approved a budget and execution plan to negotiate Prototype Other Transaction (OT) projects pursuant to 10 U.S.C. § 4022 following Sword 26.

• The amount of any future OT award is not specified.

What could I use the funding for?

Prize funds are awarded through the Challenge.

If selected for a Prototype OT under 10 U.S.C. § 4022, funding would support development and prototyping of:

• Portable, network-capable hemodynamic monitoring devices

• Hardware, software, and networking components

• Demonstration and battlefield testing (up to 30 systems expected for Phase 3 testing)

Specific allowable cost categories are not detailed in the announcement.

Are there any additional benefits I would receive?

Selected teams may receive:

• Invitation to submit a Prototype OT proposal without further competition

• Participation in Sword 2026 (May 8–12, 2026)

• Engagement with DoW stakeholders and mission partners

• Potential participation in future exercises

• Consideration for scaling solutions into operational capabilities

DIU may assist in accelerating timelines for research approvals, subject to applicable processes and approvals.

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

Responses Due By: 2026-03-02 23:59:59 US/Eastern Time.

All dates are tentative and subject to change.

Prize Challenge Phases 1–3

• Feb 17, 2026: Open Call Release

• Feb 26, 2026: AMA Session (11:00 AM ET)

• Mar 2, 2026: Open Call Submission Window Closes

• Week of Mar 9, 2026: Semi-finalists Notified

• Apr 7–8, 2026: Virtual Pitches & Interviews

• Apr 10, 2026: Finalists Notified

• May 8–12, 2026: Sword 2026 Demonstration Event

• Week of Jun 8, 2026: Winners Announced

Prototype OT Phase

• June 2026: Top performers from Sword 2026 may be invited to submit a proposal for a Prototype OT pursuant to 10 U.S.C. § 4022, without further competition.

Prize payment timing is not specified.

Where does this funding come from?

This Challenge is issued by the Defense Innovation Unit (DIU) in partnership with Project Manager Soldier Medical Devices and other Department of War (DoW) stakeholders.

Who is eligible to apply?

Eligibility includes:

• Any U.S. or International Participants (subject to security screening before acceptance to finals)

• Ability to demonstrate capabilities at a Department-determined test site in Europe by May 2026

• Small businesses and non-traditional defense vendors are encouraged to apply

If advancing to Phase 4 (Prototype OT), teams must either:

• Include at least one non-traditional defense contractor or non-profit research institution with significant participation, or

• Ensure at least one-third of total OT costs are paid by parties other than the government

Companies must:

• Register in SAM and obtain a CAGE code (if selected for a Prototype agreement)

Non-Traditional Defense Contractor definition is provided in accordance with 10 U.S.C 2302(9).

What companies and projects are likely to win?

The DoW seeks:

• Portable, ruggedized, lightweight hemodynamic monitoring devices

• Minimum 72-hour operation without recharge

• Wireless data transmission

• Predictive warning indicators for dangerous hemodynamic status

• Usability by medical and non-medically trained personnel

• Integration with DoW and allied systems (e.g., electronic health record, BATDOK, ATAK)

• Cloud and on-premise functionality

• Internal data logging for DDIL environments

Additional favorable attributes:

• Extensibility to TCCC, CASEVAC, MEDEVAC, resupply

• Rapid fielding capability and exportability to allies

• Existing ATO or system-of-record certification

• FedRAMP Moderate and DISA IL-5 (PA), with final product compliant with FedRAMP High

• U.S. National Security Facility Clearance

• Manufacturing capacity for up to 15,000 units in first production year

White papers are judged on:

1. Introduction

2. System Effectiveness

3. Technical Feasibility

4. System Scalability/Economics

5. Commercial Viability

6. Submission Quality

Are there any restrictions I should know about?

• White paper limited to five (5) pages, 11-point Calibri, single-spaced

• Must use provided template

• Submit as PDF

• Footnotes not permitted

• References must be within page limit

• Must acknowledge familiarity with DoW Ethical Principles for AI and DIU Responsible AI Guidelines

• Must comply with 32 CFR 219 and DoDI 3216.02 if human subjects research is required

• Medical devices must seek FDA 510(k) clearance (minimally in trauma patients) and receive clearance before procurement and fielding

• Vendors with cloud solutions must meet FedRAMP and DISA IL requirements as stated

• DIU reserves the right to cancel, suspend, or modify the Challenge

How long will it take me to prepare an application?

Preparation time will depend on:

• Maturity of your technical solution

• Readiness to address regulatory (FDA), security (FedRAMP, DISA IL-5), and manufacturing scale requirements

• Ability to align with Responsible AI Guidelines

How can BW&CO help?

BW&CO can support you by:

• Assessing eligibility and OT strategy

• Structuring your white paper against the six evaluation criteria

• Positioning your solution for both prize selection and follow-on Prototype OT

• Clarifying Responsible AI, regulatory, and security alignment narratives

• Preparing you for the April 7–8, 2026 pitch event

Our goal is to help you compete not just for the prize pool, but for the potential 10 U.S.C. § 4022 Prototype OT without further competition.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements for submitting application ($9,000) available.

Additional Resources

Review the solicitation here.