Program to leverage advances in bio-artificial blood substitute technologies to sustain warfighter, civilian casualties in austere environments
May 11, 2021
In military, and many civilian settings, hemorrhage is the leading cause of potentially survivable, traumatic pre-hospital death. 1, 2, 3 Transfusion of whole blood is the preferred resuscitation fluid in tactical combat casualty care.4 However, its use in far-forward operations is challenging because of storage requirements, limited shelf-life, and logistical constraints. DARPA’s new Fieldable Solutions for Hemorrhage with bio-Artificial Resuscitation Products (FSHARP) program aims to leverage recent technical advances to meet the critical and immediate need for blood product alternatives.
“FSHARP links innovation across three areas to overcome the logistical challenges of whole blood in forward settings: new approaches to designing blood component substitutes; integration of those simulants into resuscitation products that approximate whole blood; and manufacturing and stabilization technology to ensure availability and functionality in challenging environments,” stated Commander Jean-Paul Chretien, FSHARP program manager. “FSHARP also begins to reduce dependence on donations for blood products. Ultimately, we envision products that can be designed for clinical requirements and manufactured at the scale needed regardless of donor supply.”
FSHARP is a four-year effort, organized as two sequential 24-month phases, during which two Technical Areas (TAs) will be concurrently addressed. The objective of TA1, Blood Substitute Development, is to develop multiple therapeutically-active bio-artificial components that will address oxygen delivery, cessation of bleeding, and replacement of volume. 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, and to be manufactured in sufficient quantities on a timescale that meets DoD needs. Performers will complete yearly demonstrations to prove capabilities.
Performers will develop bio-artificial products that perform the therapeutic functions of blood components important for resuscitation; integration of these products into formulations that can be co-administered to achieve near-parity to whole blood functionality with no adverse effects; preservation processes that impart up to 6-months-long shelf-stability in a variety of expected operational conditions without cold-chain requirement; and manufacturing processes and technologies that enable quick, scalable, cost-effective, and consistent production.
“We expect proposers may draw on recent innovations such as nanoparticle platforms for oxygen delivery, wound-sealing, or correction of disorders that accompany trauma,” added Chretien. “With flexible design approaches like these, along with new computational and in vitro testing platforms, rapid prototyping is possible to ensure the components work together and can be tailored to specific clinical scenarios.”
Proposers must plan to verify effectiveness and safety of their bio-artificial blood substitutes in studies that could support submission of an FDA Investigational New Drug (IND) application. Proposers must also plan to demonstrate manufacturing capabilities in accordance with Good Manufacturing Practices (GMP) guidelines.
Interested proposers have until July 27, 2021 to submit their proposals. A forthcoming Broad Agency Announcement on FSHARP will be posted to SAM.gov.
1 Eastridge BJ, Mabry RL, Sguin P, et al. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg 2012; 73:S431.
2 Callcut RA, Kornblith LZ, Conroy AS, et al. The why and how our trauma patients die: a prospective multicenter Western Trauma Association study. J Trauma Acute Care Surg 2019; 96:864.
3 Koh EY, Oyeniyi BT, Fox EE, et al. Trends in potentially preventable trauma deaths between 2005-2006 and 2012-2013. Am J Surg 2019; 218:50.
4 Butler FK, Holcomb JB, Shackelford S, et al. Advanced resuscitative care in tactical combat casualty care: TCCC guidelines change 18-01:14 October 2018. J Spec Oper Med 2018; 18:37.
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