MTEC - Prevention of Combat Wound Infections

The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for an Other Transaction Agreement for prototype projects Request for Project Proposals (RPP) to develop prototype solutions for the prevention of infection of combat wounds. This RPP seeks a non-surgical, definitive solution(s) for a moderate to severe dermal disruption (penetrating wounds) with a focus on averting infection, with the ultimate goal of returning the Service Member to full functional duty without the need for evacuation. The proposed solution(s) may also be used as a temporary treatment when surgical capability is unavailable. BACKGROUND Combat wound infections in a prolonged care environment are a major risk to Warfighter survivability and their ability to return to duty, posing a significant burden to an Army Health System that has little to no capacity for significant periods of time during Multi-Domain Operations. Research has shown that greater than 30% of all combat wounds become infected. That percentage is expected to rise in a prolonged care environment, hence integrated interventions provided by Tactical Combat Casualty Care (TCCC) providers at the point of injury are critically important to diminish the occurrence of infection in battlefield wounds. OVERALL PROGRAM OBJECTIVE The goal of this RPP is to develop prototype solutions that enable prevention of Warfighter wound infections on the battlefield as close to the point of injury as possible to enable speedy return of Warfighters to duty and without requiring evacuation to higher roles of care. Therefore, this requirement is focused on a multi-layered approach to protecting Warfighters against wound infections. The proposed solution(s) is expected to be part of a system to provide an adequate response to complex traumatic penetrating injuries that can lead to wound infections. Minimum Requirements for Submission of an Enhanced White Paper: The Technology Readiness Level (TRL) at the start of the period of performance (PoP) is 3/4 and at the end of the PoP is TRL 6/7 [definition of TRLs can be found here: https://mtec-sc.org/wp- content/uploads/2016/12/TRL-definitions.pdf] At the time of submission, the Offeror shall have a candidate solution with non-clinical data (in vitro, toxicology, pre-clinical animal data, etc.) indicating safety and/or efficacy. The Offeror shall have demonstrated manufacturing feasibility of the candidate solution. In addition to these minimum requirements, it is strongly preferred that Offerors have had at least one meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory strategy for their candidate(s). Therefore, proposals demonstrating evidence of the FDA engagement may receive a higher rating. An ideal solution would meet the following requirements (not listed in order of importance): Broad and rapid microbicidal (bacterial and/or fungal) activity with a shelf life of at least a year. For proposed solutions that may have to be opened multiple times, it is preferred that the - use within period is at least one year. Ease of use, small and lightweight (i.e., should fit in a combat medic's medical bag) without the need for additional logistic considerations, e.g., cold/warm storage, impact protection, additional supplies/products to enable use. When placed into a wound, the product should not stain the skin or surrounding exposed underlying tissue and should be easily removable (i.e., washed out of the site of placement with sterile water or saline). The product should be usable and efficacious in austere environment conditions, as well as packaging that maintains integrity in wide temperature ranges (between 0-45oC), and also in conditions of high and low humidity. Demonstrable efficacious use of the product on the wound for at least three days in austere environmental conditions referenced above. At the end of the PoP, the performer(s) is expected to have successfully achieved the following milestones: Completed Good Laboratory Practice (GLP)-compliant study demonstrating acceptable safety and efficacy profile in relevant animal model(s), human dose equivalent, and route of administration as intended for human use. Completed a Phase 1 clinical trial demonstrating adequate safety and preliminary efficacy profile in optimized dose and schedule. A Defined Regulatory Pathway: An adequately defined, detailed regulatory pathway towards a Medical Device, Biologics License or New Drug Application, including (but not limited to) Phase 2 and 3 study plans validated by formal communication with the FDA. Evidence that production is capable of scale up and available quantities of the product are adequate to support the remainder of clinical development. Demonstrated stability of product(s) for at least one year at 0-45oC and under conditions of high humidity. POTENTIAL FUNDING AVAILABILITY AND POP The Government Department of Defense (DoD) currently has approximately $4 Million (M) available for a PoP for up to 24 months. Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the $4M in Government funding to be provided under the resultant award(s). It is expected that MTEC will make up to two awards to qualified Offerors to accomplish the statement of work. Potential follow-on work may include (but is not limited to) manufacturing of prototypes for further clinical testing and further clinical testing of candidate prototypes. ACQUISITION STRATEGY This RPP will be conducted using the Enhanced White Paper approach. In Stage 1, current MTEC members are invited to submit Enhanced White Papers using the mandatory format contained in this RPP (see Section 8 of the version of the RPP available on MTEC's website). The Government will evaluate Enhanced White Papers submitted and will select those that best meet their current technology priorities using the criteria in Section 5 of the full RPP. An Offeror(s) whose proposed solution is selected for further consideration based on the Enhanced White Paper evaluation will be invited to submit a full cost proposal in Stage 2. Notification letters will contain specific Stage 2 proposal submission requirements. For more information regarding the requirements of the Enhanced White Paper process and template, refer to the full version of the RPP (see the bottom of this posting for a link to MTEC's website). MTEC The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting 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, - nontraditional government contractors, academic research institutions, and not-for-profit organizations. ADMINISTRATIVE INFORMATION Enhanced White Papers are due no later than December 17, 2020 at 12:00pm Eastern Time. The full version of the RPP is posted to the MTEC website (mtec-sc.org). MTEC membership is required for the submission of an Enhanced White Paper in response to the MTEC RPP. Offerors submitting Enhanced White Papers as the prime contractor must be MTEC members of good standing by December 14, 2020. To join MTEC, please visit http://mtec- sc.org/how-to-join/ POINTS OF CONTACT Please direct your inquiries and correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator at contact@example.gov Technical and membership questions - Dr. Lauren Palestrini, MTEC Director of Research, contact@example.gov Administrative questions - Ms. Kathy Zolman, MTEC Director of Program Operations, contact@example.gov To view the full version of the solicitation please visit MTEC's website at: https://www.mtec-sc.org/solicitations/