The Defense Threat Reduction Agency (DTRA) has released a Statement of Objectives (SOO) to develop prototype Medical Countermeasures (MCMs) aimed at addressing therapeutic indications of Warfigher exposure to viral and bacterial biothreat agents.
Key Information and Deadlines
The Project Agreement Holder must state if their proposal is for the solution of the objecties of Thrust 1, Thrust 2, or a combination of Thrust 1 and 2 in their entirety. Once the government receives the proposals, they will evaluate solutions either against Thrust 1 or Thrust 2 independently, or the consolidated solutions including both Thrust 1 and Thrust 2.
The expected Period of Performance for this effort is up to three (3) years from the date of award, although longer durations may be considered. Specific timelines will be negotiated. It is anticipated that the primary location for the work will be the facilities of the Project Agreement Holders; however, this aspect is open for negotiation as part of their submission.
The anticipated award date for this effort is Q2 FY2025.
Project Scope and Objectives
The primary aim of this project is to develop prototype MCMs addressing Warfighter exposure to viral and bacterial biothreat agents. The two solutions that are needed are for Thrust Area 1, Thurst Area 2, or both Thrust Area 1 & 2.
- Direct Acting MCM (Thrust Area 1): Focus on broad-spectrum antiviral MCMs for viral families like Filoviridae, Togaviridae, etc. Screening for emerging and traditional viruses is encouraged. Priorities include oral, broad-spectrum, and combination therapies, with preference for repurposed commercial compounds. Platform technologies enhancing bioavailability are also of interest.
- Host-Directed Therapies (Thrust Area 2): Focus on MCMs targeting host pathways related to conditions like acute respiratory distress syndrome (ARDS) and sepsis. Must demonstrate broad-spectrum efficacy against bacterial and viral threats (e.g., Bacillus anthracis, Yersinia pestis). Combination therapies using FDA-approved products are preferred, particularly if they enhance treatment efficacy or reduce drug resistance.
Summary
This solicitation welcomes proposals for activities ranging from discovery to Phase 1 clinical trials (TRL1-6), with a focus on traditional drug development plans, though innovative approaches, especially for combination therapies, are encouraged. Multiple awards are anticipated for promising candidates, with projects concluding after proof-of-concept evaluation in small animals. Proposals for more advanced candidates that have completed Phase 1 clinical trials are also welcome. Proposals can be structured in phases, possibly within a 36-month period of performance, and must include decision gates to justify follow-on work.
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