SAM #DARPA-PA-26-09

DARPA RAPIID TA-3: Research and Regulatory Advancement for Deployable Blood Analog Systems

DARPA's Biological Technologies Office is seeking proposals for Task Area 3 (TA-3) of the RAPIID program, focused on advancing deployable blood analog systems from laboratory proof-of-concept to clinical and field use. - Government Buyer: - Defense Advanced Research Projects Agency (DARPA), Biological Technologies Office (BTO) - OEMs and Vendors: - No specific OEMs or vendors are named for the blood analog systems - Example participants in a related demonstration (PBJ sandwich optimization) include Pepperidge Farm, Jif, and Smuckers laboratories - Products/Services Requested: - Research and development services to advance shelf-stable blood analog products - Includes preclinical evaluation, regulatory sponsorship (IND/IDE submissions), clinical trial design and execution (Phase I and II trauma trials), data management, and clinical practice guideline development - Requires in-house Clinical Research Organization (CRO) or Academic Research Organization (ARO) capabilities - Coordination with other RAPIID program task areas - Additional demonstration task (PBJ sandwich optimization) involving protocol development, optimization experiments, and taste-testing panel - Unique or Notable Requirements: - Experience with multi-site trauma clinical trials and regulatory sponsorship - Engagement with military and civilian trauma care leadership - Ability to conduct GLP-compliant preclinical testing and manage regulatory submissions - Development of enabling field technologies for blood analog deployment - For the PBJ demonstration: optimization of food product assembly and sensory evaluation - No specific products, part numbers, or purchase quantities are listed for the main RAPIID TA-3 effort

Description

Please note that this announcement specifically solicits proposals only for Task Area 3 (TA-3) of the RAPIID program. Primary challenges with translating technological advancements from the laboratory to real-world usage include a lack of investment to ensure manufacturing scalability, and usability, as well as clinical, regulatory, and commercialization preparedness. Previous investments by DARPA to address potential blood shortages in austere, pre-hospital settings (i.e., the Fieldable Solutions for Hemorrhage with bio-Artificial Resuscitation Products (FSHARP) program) have derisked scalable, shelf-stable components that would provide the resuscitative functions of whole blood (i.e., oxygen delivery, hemostasis, and volume expansion) when used together. However, bringing those components through clinical studies and regulatory approval as well as the development of enabling technologies and guidance to facilitate their use outside of the laboratory were out-of-scope in previous DARPA efforts. RAPIID is designed to bridge the gap between the proof-of-concept achievements of the FSHARP program and actual clinical use by the military and civilians. With FSHARP demonstrating that shelf-stable blood products can be created, DARPA is now taking on the next challenge: delivering a complete, deployable, and authorized system that can save lives in the field. To achieve this goal, RAPIID will focus on pushing high technology readiness level (TRL)/medical readiness level (MRL) capabilities through the regulatory process by funding studies to demonstrate safety and efficacy of blood analog components and their ability to work in combination; manufacturing scalability of individual blood analog components; and developing and scaling associated fielding technologies.

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