Resuscitation and Prevention of Ischemia-Induced Dysfunction (RAPIID) - TA3

The Defense Advanced Research Projects Agency seeks a single awardee to serve as a Contract Research Organization or Academic Research Organization to manage clinical trials, regulatory submissions, and preclinical testing for the Resuscitation and Prevention of Ischemia-Induced Dysfunction (RAPIID) Task Area 3 program, with proposals due July 29, 2026 at 3:00 PM ET. The award will be made under an Other Transaction for Research agreement; DARPA anticipates funding one contract.

Organizations awarded funds under TA-1 or TA-2 are ineligible, as are organizations with any financial, advisory, or commercialization interests in TA-1 or TA-2 performers, products, or technologies. FFRDCs, UARCs, and Government entities are not eligible. No set-aside applies.

TA-3 must provide unified accountability for the clinical and regulatory lifecycle of shelf-stable blood analog components, including multi-site trauma clinical trial sponsorship with Exception from Informed Consent expertise, IND and IDE regulatory submissions, GLP-compliant large-animal model execution, clinical data management, statistical oversight, and engagement with the Joint Trauma System and Committee on Tactical Combat Casualty Care for clinical practice guideline development. Proposers must demonstrate established in-house capabilities in multi-site trauma sponsorship, regulatory sponsorship authority, CRO-like operations, combination product testing, GLP-compliant large-animal models, and peer-reviewed publication records from completed trauma trials.

The program spans 36 months total: Phase 1 (Base, 12 months) and Phase 2 (Option, 24 months). Phase 1 deliverables include demonstrating combination non-inferiority to stored whole blood, completing IND-enabling assessments, submitting an IND package to the FDA, and achieving CMMC Level 2 certification by Month 3. Phase 2 includes initiating and completing Phase I and Phase II clinical trials and completing diagnostic and device validation studies.

Proposers must submit a technical and management proposal (maximum 10 pages), fixed payable milestones tied to technical metrics, detailed cost proposals with the DARPA Standard Cost Proposal Spreadsheet, and a completed sample OT agreement with tracked changes if modifications are proposed. Principal investigator effort should be a minimum of 20%. The NAICS code is 541714, Research and Development in Biotechnology (except Nanobiotechnology). All RAPIID information must be marked as Controlled Unclassified Information and handled per DoDI 5200.48 and DFARS 252.204-7012 requirements.