Candidate Acute Traumatic Brain Injury (TBI) Management Capabilities (CATMC) and Acute TBI Diagnostics and Monitoring (ATDM) in Austere Environments

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Army Medical Research and Development Command (USAMRDC) Combat Casualty Care Research Program (CCCRP). Strategic oversight for the award(s) supported by this RPP will be provided by USAMRDC. Project management will be conducted by the Congressional Directed Medical Research Program (CDMRP). Portfolio management will be conducted by CCCRP.

This program aims to support the acute diagnostic, therapeutic and management technologies across the spectrum of traumatic brain injury (TBI) severities capable of being used in a farforward operational environment:

• Focus Area #1 - Treatments: Development of an acute treatment (pharmaceutical, technology, etc.) for TBI.
• Focus Area #2 - Diagnostics: Diagnostic, prognostic, and management technologies for acute, early intervention for TBI.

Scope of Work

Base Period of Performance (PoP1) (up to 24 months)

The initial maximum of this 24-month, PoP1 should be focused on tasks relevant to advance the prototype to the next Technology Readiness Level (TRL). Project scope should be proposed based on the prototype’s maturity (TRL 4 vs. 5) at the time of submission. The work in the base PoP1 could include, but is not limited to:

• Prototype refinement/maturation progressing towards clinical product.
• Pre-clinical work (as needed) to support an Investigational Device Exemption (IDE) or Investigational New Drug (IND) application (or other appropriate U.S. Food and Drug Administration (FDA)) submission.
• Animal studies under Good Laboratory Practice (GLP) (as needed) to support the IDE or IND (or other appropriate FDA) submission.
• IDE or IND (or other appropriate FDA) submission.
• Clinical safety studies (as needed) to support regulatory approval/clearance.
• Clinical feasibility studies (as needed) to support regulatory approval/clearance.
• Clinical pivotal studies (as needed) to support regulatory approval/clearance.
• Stability and shelf-life studies, considering military-relevant environments.
• Establishment of Good Manufacturing Practice (GMP) manufacturing for clinical trials and for market release.
• Interoperability and open-source technology.
• Initial production runs, first article testing, etc.
• Low rate initial product runs to reach Full Operating Capability (FOC).
• Draft product support documentation (e.g., training guides, product inserts, etc.).
• Development of a business and/or commercialization plan for market release.

Go/No-Go Decision Point

Prior to the end of the base PoP (tentatively projected to occur 20 months into PoP1), the Government will conduct an in-process review (IPR), which the Awardees will attend and participate in to assess the work completed for each PoP1 Awardee. The IPR will be an in-person meeting at USAMRDC at Fort Detrick, MD. Following the IPR, the Government intends to down-select Awardees to a smaller number for continuation of funding for the conduct of follow-on work representing PoP2 or the subsequent PoP of the prototype project. This downselect represents the Go/No-Go decision point between PoP1 (base) and PoP2 (subsequent).

In preparation for the IPR, all awardees shall submit a deliverable to the Government. Each Awardee shall submit full details of the tasks proposed for the subsequent PoP (PoP2) phase, in separate technical and cost volumes, as a deliverable to the Government. The exact due date for this deliverable is to be determined (TBD) (anticipated on or about two weeks prior to the date of the IPR). This deliverable will be reviewed and evaluated as part of the Go/No-Go decision point, at which time the Government will make award recommendations for the subsequent PoP selections.

All Offerors responding to this RPP shall account for the IPR requirement and associated deliverable requirement by identifying these as a milestone(s) in the Step 1 (Solution Brief) submission.

Potential for Follow-on Work

Potential follow-on work for PoP2 and subsequent PoPs may be awarded based on the advancement in prototype maturity during the base PoP1. Potential follow-on work may include tasks related to advancement of prototype maturity to achieve TRL 7, and/or to expand the use or utility of the prototype.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.