MTEC understands the importance of sharing technical requirements as soon as possible with both members and to potential consortium members in order to allow the maximum possible time to prepare, team, and identify both public and private solicitation sponsors. Draft Request for Project Proposals will be shared via email upon request and this website. Understand that this information is draft in nature and changes could occur prior to publication of final documents. For specific Request for Project Information or Request for Project Proposal inquiries, please direct your correspondence to the following contacts:
- Questions concerning contractual, cost or pricing should be directed to the MTEC Contracts Manager, Ms. Lisa Fisher, firstname.lastname@example.org
- Technology Readiness Levels (TRLs) for most proposed projects must be identified and included with the Technical Proposal. TRL definitions are provided here. Technical related questions should be directed to the MTEC Director of Research, Dr. Lauren Palestrini, Ph.D., email@example.com
- Questions concerning membership should be directed to Ms. Stacey Lindbergh, MTEC Executive Director, firstname.lastname@example.org
- All other questions should be directed to Ms. Kathy Zolman, MTEC Program Manager, email@example.com
Development and Evaluation of a Cryopreserved Platelet (CPP) Product for the U.S. Military
Solicitation Number: MTEC-18-06-CPP
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.
Overall Program Objective:
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.
Offerors are expected to conduct all manner of development, test and evaluation activities (as necessary) to achieve an FDA-licensed CPP product that is suitable for use by the U.S. Military. Anticipated activities include (but are not limited to):
- Design and development of a CPP manufacturing process that is compliant with FDA regulations and applicable guidance for current good manufacturing practices (cGMP).
- Design, development, and validation of processes (inclusive of any necessary materials, equipment, and tests/assays) to enable storage and shipment of CPP for U.S. Military use.
- Performance of all necessary non-clinical (in-vitro) studies and clinical trials.
- Execution of all activities commensurate with serving as the IND holder and regulatory sponsor in accordance with 21 Code of Federal Regulations (CFR) 312 subpart D, including all regulatory submissions and regulatory sponsorship.
- Development and maintenance of various management, risk, project, and quality plans/reports (as necessary) to provide documented evidence that the development effort is being effectively managed in accordance with the risk profile.
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.
The MTEC will use a streamlined, accelerated approach for this acquisition. This approach will consist of the following steps:
Step 1: MTEC members who wish to offer a solution to the RPP must submit a Solutions Brief. The Solutions Brief will contain the MTEC Offeror’s technical concept and approach along with their viability toward the specific effort. To meet the statutory requirement of the Other Transaction authority, Offeror Solutions Briefs will also have to address the significant participation of a Nontraditional Defense Contractor or Nonprofit Research Organization on the team or the willingness to provide 1/3 cost share to the project. The Offeror will also be expected to present a rough order of magnitude (ROM) cost and schedule.
Step 2: As part of the Government review of the Solutions Brief, MTEC members who have submitted a favorable Solutions Brief based on the RPP criteria may be invited to present and discuss their solution with the Government sponsors for the research via a virtual or in-person “pitch” of the proposed project along with a SOW/Milestone Payment Schedule and cost information.
Step 3: MTEC Offeror(s) will be notified of the down select recommendation(s), and if selected, will be invited to submit a detailed Cost Proposal in accordance with the MTEC Proposal Preparation Guide (PPG).Because of the nature of the requirements set forth in the forthcoming RPP, this streamlined, interactive approach is anticipated to be a better means to highlight company methodologies and skills and allow the government to gain a fuller appreciation of the work required to be completed. It provides more freedom and initiative to the Offeror to describe how they would approach and solve such an action. The full description of this contracting approach is included in the RPP.
The MTEC mission is to assist the U.S. Army Medical Research and Materiel Command (USAMRMC) by providing cutting-edge technologies and effective materiel life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, “non-traditional” government contractors, academic research institutions and not-for-profit organizations.
Solution Briefs are due no later than August 17, 2018 at 12:00pm EST. This RPP is posted to the MTEC website (www.mtec-sc.org) and FedBizOpps (www.fbo.gov) to notify interested parties. MTEC membership is required for the submission of a Solution Brief response to this MTEC RPP. Offerors submitting Solution Briefs as the prime contractor must be MTEC members of good standing by August 14, 2018. To join MTEC, please visit http://mtec-sc.org/how-to-join/
A Proposers Conference via webinar will be held for interested parties to have their questions answered by the Government after the RPP is posted. MTEC Members will be notified when the Proposers Conference is scheduled.
For inquiries regarding this announcement, please direct your correspondence to the following contacts:
- Technical questions
Dr. Lauren Palestrini, MTEC Director of Research, Lauren.Palestrini@officer.mtec-sc.org
- Contracting questions
Ms. Rebecca Harmon, MTEC Contracting, firstname.lastname@example.org
- Administrative questions
Ms. Kathy Zolman, MTEC Program Manager, Kathy.Zolman@ati.org
- Membership questions
Ms. Stacey Lindbergh, MTEC Executive Director, email@example.com
To view this solicitation, click here.