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Medical Technology Enterprise Consortium (MTEC) -- Development and Evaluation of a Cryopreserved Platelet (CPP) Product for the U.S. Military
The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) focused on the development of a dimethyl sulfoxide (DMSO) cryopreserved platelet (CPP) product that has an extended shelf life (minimum of 2 years). The overall end goal of the program is a commercial product that is approved by the U.S. Food and Drug Administration (FDA) to enhance the battlefield management of severe hemorrhage resulting from combat trauma.
Management of severe hemorrhage due to trauma and/or surgical repair of damaged organs and tissues, requires the contemporaneous replacement of large volumes of blood products, including platelets. Platelets are a normal component of blood and a key initiating factor in hemostasis (blood clotting). Current standard of care in both civilian and military settings consists of walking donor, room-temperature stored, apheresis platelets (i.e., LSP), which only have a shelf-life of 5-7 days with decreasing efficacy during this period of storage. Platelet supply in an unsettled military theater of operations is inherently limited due to the inability to store current platelet products for more than 5-7 days. In the event of in-theater mass casualty situations, the supply of walking donor apheresis platelets will not meet demand; compromising the ability (and capacity) of U.S. Army field medical teams to curtail bleeding and stabilize patients.
The leading candidate for a long-term stored platelet product, by virtue of technological maturity and risk, is DMSO CPP. DMSO CPP is a frozen platelet product (regulated as a biologic by the U.S. FDA) composed of γ-irradiated [2500 centi-gray (cGy)] leukocyte reduced apheresis platelets stored in plasma and anticoagulant citrate dextrose solution A (for up to 57 hours after apheresis), concentrated, and frozen in approximately 6% DMSO at -80°C and stored at ≤ -65°C. Hence forward, this candidate will be referred to as CPP. Development of CPP is in direct support of the USAMMDA’s line of effort to enhance battlefield management of severe hemorrhage due to combat trauma.
The objective of this program is to achieve an FDA licensed, commercially viable CPP product.
Solution Briefs are due no later than August 17, 2018.
Offerors must be MTEC Members in good standing.
The U.S. Department of Defense (DoD) currently anticipates up to $36 Million (M) in funding for Fiscal Years (FY) 18-24, with an expected start date of December 31, 2018 (subject to change).
It is expected that MTEC will make a single award to a qualified team to accomplish all tasks. The program shall be led by a centralized point of contact at the prime contracting organization. If a single Solution Brief is unable to sufficiently address the entire scope of this RPP’s objectives, several Offerors may be asked to work together in a collaborative manner or MTEC may make multiple, individual awards to Performers(s) to accomplish subset(s) of the key tasks.