Fieldable Solutions for Hemorrhage with bio-Artificial Resuscitation Products (FSHARP)

Funding Agency:
Department of Defense

The Defense Advanced Research Projects Agency (DARPA) is soliciting innovative proposals to develop a deployable, shelf-stable, universal whole blood substitute as a hemorrhage countermeasure to sustain injured warfighters and civilians in austere, pre-hospital settings. Proposals should address the following areas for technical innovation: (1) development of bioartificial resuscitation products that perform the therapeutic functions of blood components important for resuscitation (e.g., oxygen delivery; hemostasis, or cessation of bleeding; volume expansion); (2) integration of products into formulations that enable co-administration to achieve near-parity to whole blood functionality with no adverse effects; (3) preservation processes that impart months-long shelf-stability in a variety of expected operational conditions without coldchain requirement; and (4) manufacturing processes and technologies that enable quick, scalable, and consistent production of formulations. Proposed research should develop innovative technologies to enable cost-effective production of resuscitative formulations suitable for use in field-forward locations. Specifically excluded is research that primarily results in incremental improvements to the existing state of practice

Deadlines:

o Proposal Abstract Due Date and Time: June 22, 2021, 4:00 PM ET

o Full Proposal Due Date and Time: August 10, 2021, 4:00 PM ET

Agency Website

Areas of Interest

The program consists of two Technical Areas (TAs) to be addressed concurrently:

  • Technical Area 1 (TA 1): Blood Substitute Development
  • Technical Area 2 (TA 2): Manufacturing and Stabilization

The objective of TA1, Blood Substitute Development, is to develop multiple therapeuticallyactive bio-artificial components that will address three primary lifesaving functions of whole blood in resuscitation: oxygen delivery, hemostasis, and volume expansion. Performers may also develop adjunct therapies to aid or complement the above functions. These components will be integrated into combinations that will allow for co-administration to approximate comprehensive whole blood functionality without causing adverse effects. The objective of TA2, Manufacturing and Stabilization, is to develop chemical modifications and manufacturing approaches that enable the products developed in TA1 to be produced in an easily portable form that can be maintained under a range of environmental conditions likely to be encountered in military operations and in sufficient quantities on a timescale that meets DoD needs. Proposers must plan to verify the effectiveness and safety of their bio-artificial blood substitutes in relevant models of hemorrhage in studies that could support submission of an FDA IND application. Proposers must also plan to demonstrate manufacturing capabilities in concordance with GMP guidelines.

Proposers must propose to both TAs, and both TAs must run concurrently over the duration of the effort. Proposers are responsible for ensuring their team has the requisite technical expertise, capabilities, and facilities to address all aspects of both technical areas. Proposals that fail to address both technical areas will be considered non-conforming and will not be evaluated.

Funding Type

Grant

Eligibility

Faculty

Category

Engineering and Physical Sciences
Environmental & Life Sciences
Medical
Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

August 10, 2021