Overview of Solicitation
Hemorrhage remains one of the leading causes of preventable death on the battlefield, with existing countermeasures often falling short in their transition from laboratory research to clinical and commercial application. In response, the Defense Advanced Research Projects Agency (DARPA) Biological Technologies Office (BTO) has released a Request for Information (RFI) under Special Notice DARPA-SN-26-61 seeking input from industry and academia on capabilities to support independent verification and validation, clinical trial execution, and commercialization of hemorrhage countermeasures. While this RFI does not constitute a formal solicitation and no funding award is guaranteed at this stage, it represents a clear signal that DARPA is actively scoping a future program in this space and is looking for capable partners.
Purpose and Scope of the RFI
This RFI is a preliminary market research step designed to identify organizations capable of providing third-party assessments of the safety and efficacy of potential hemorrhage countermeasures, with a focus on synthetic or biosynthetic components. DARPA is particularly interested in respondents who can comprehensively address all task domains — preclinical evaluation, clinical trial support, and commercialization — under a single provider, to maintain data continuity and tailor regulatory and market strategies efficiently. Responses should demonstrate expertise specifically rooted in hemorrhage and resuscitation products, not unrelated fields.
Capability Areas Requested
The RFI is structured around six capability domains that respondents must address in their white paper submissions:
- Organizational Capabilities and Past Performance – Core competencies in medical countermeasure development against hemorrhage, including preclinical and clinical research facilities, large animal model capacity, and prior DoD or U.S. Government experience
- Preclinical Evaluation Capabilities – Proposed technical approach for in vitro and in vivo studies assessing safety and efficacy in both small and large animal models, including Good Laboratory Practice (GLP) compliance
- Clinical Trial Support – Experience designing and managing Phase I and Phase II clinical trials or evidence of a capable clinical trial partner, and experience in regulatory affairs, including Institutional Review Boards (IRBs), IND submissions to the FDA, and patient enrollment strategies
- Technology Commercialization and Transition Support – Experience conducting technical and financial due diligence on third-party technologies, including IP landscape assessments and market analysis for drugs, biologics, and combination products
- Program Management and Key Personnel – Brief summaries of key scientific and management personnel, along with a high-level timeline for a 3-year program spanning preclinical through emergency use authorization (EUA) submission
- Rough Order of Magnitude (ROM) Estimate – A budget breakdown by major phase for a notional 5-year effort, including Preclinical Efficacy Testing, GLP Preclinical Testing, Phase I and Phase II Clinical Trials
Submission Format and Key Deadline
DARPA strongly encourages focused and concise submissions. White paper responses are limited to 10 pages, using 12-point font with 1-inch margins on standard 8.5 x 11-inch paper. All submissions must be delivered electronically in PDF format. The response deadline is May 4, 2026, at 4:00 PM ET. All correspondence and submissions should be directed to [email protected]. Emails sent directly to the Program Manager may result in delayed or no response.
What This RFI Means for Potential Performers
It is important to understand that this RFI is issued solely for information and planning purposes, and DARPA will not reimburse respondents for the cost of preparing or submitting a response. Responding to this RFI is also not required to propose to any subsequent Broad Agency Announcement (BAA) or formal solicitation that may follow. That said, engaging now by submitting a strong, well-scoped white paper is a strategic opportunity to shape DARPA’s understanding of market capability and position your organization as a credible partner ahead of any formal award process.
Advancing Warfighter Survivability Through Innovative Medical Countermeasures
This RFI reflects DARPA BTO’s broader mission to develop next-generation medical countermeasures that protect and restore the health of U.S. warfighters in the field. By identifying organizations capable of bridging the gap between laboratory innovation and clinical and commercial readiness, DARPA is laying the groundwork for a program that could meaningfully advance how hemorrhage is treated both on and off the battlefield. Organizations with relevant expertise in preclinical testing, clinical trials, or medical product commercialization should take note of this early-stage opportunity.
If your company is considering responding to this RFI or positioning for the potential program that may follow, your federal funding journey starts here. EverGlade is a national firm that helps organizations win and manage federal awards. We offer services ranging from Pursuit, Proposal, and Post-Award support to comply with federal regulations at agencies including BARDA, ARPA-H, NIH, DTRA, JPEO, DOD, DIU, DOE, and DARPA.
