Inactive

PRE-ANNOUNCEMENT “Candidate Acute Traumatic Brain Injury (TBI) Management Capabilities (CATMC) and Acute TBI Diagnostics and Monitoring (ATDM) in Austere Environments” The Medical Technology Enterpris... PRE-ANNOUNCEMENT “Candidate Acute Traumatic Brain Injury (TBI) Management Capabilities (CATMC) and Acute TBI Diagnostics and Monitoring (ATDM) in Austere Environments” The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on the support of acute diagnostic, therapeutic and management technologies across the spectrum of traumatic brain injury (TBI) severities capable of being used in a far-forward operational environment: FOCUS AREA #1 (Treatments): Development of a treatment (pharmaceutical, technology, etc.) for TBI. FOCUS AREA #2 (Diagnostics): Diagnostic, prognostic and management technologies for acute, early intervention for TBI. The goal of this program is to fund projects to complete technology readiness level (TRL) 6. To achieve this, MTEC and the U.S. Government (USG) Department of Defense (DoD) will utilize a rolling down-select approach during the performance of prototype projects awarded as a result of the RPP. Using this approach, the Government intends to award projects, structured into two Periods of Performance (PoPs), with an initial base period (PoP1) reflecting the first of the two PoPs. More detail is provided below. Technical Focus Area: Traumatic brain injury (TBI) is a major health burden in both military and civilian populations. In the last two decades, there have been approximately 420,000 documented incidents of Service members sustaining at least one TBI. Future combat operations are expected to result in an increase in time to evacuation, delaying TBI diagnosis and treatment during the most critical period after injury. The DoD U.S. Army Medical Research and Development Command’s (USAMRDC’s) Combat Casualty Care Research Program (CCCRP) has identified two focus areas for funding. To meet the intent of this upcoming RPP, Offerors should only propose technology solutions that meet the following two criteria: Currently be at TRL of 4 or 5 [definition of TRLs – https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf]; and, Currently be in development or commercially available. Each Solution Brief MUST specifically address only ONE of the two Focus Areas described below. Offerors are not limited to a single Solution Brief submission. Projects not aligned to at least one of these Focus Areas will not be considered for funding. FOCUS AREA #1 (Treatments): Development of a treatment (pharmaceutical, technological, etc.) for traumatic brain injury. The intent of this focus area is to enable the advancement of candidate treatments (pharmaceutical, technological, etc.) to TRL 6 for the treatment of TBI, for eventual evaluation by the TBI Clinical Trial Network as appropriate. Despite the enormous burden of TBI on Service members and their family, there is no effective therapeutic intervention approved by the U.S. Food and Drug Administration (FDA). In addition to the complexities of treating TBI, future operational environments pose an addition barrier to the treatment of TBI: time and location. Through MTEC, the DoD U.S. Army Medical Materiel Development Activity (USAMMDA) has recently made an award and established a contractual relationship with a competent and experienced TBI Clinical Trial Network to enable the rapid clinical testing of several TBI drug candidates. The intent of this prior award was to establish an experienced and funded infrastructure that could be made available to drug sponsors/industry partners for the evaluation of candidate TBI drugs in Phase 2 clinical trials. The awarded TBI Clinical Trial Network (https://tracktbinet.ucsf.edu/) brings 18 potential clinical sites and staff that are very familiar with TBI diagnosis, studies, and treatment. The already awarded TBI Clinical Trial Network is now poised and ready to collaborate with several drug sponsors/industry partners to design and execute focused Phase 2 clinical trials on TBI drug candidates, with the goal to reduce the overall risk of future investment in a Phase 3 clinical trial for TBI. FOCUS AREA #2 (Diagnostics): Diagnostic, prognostic and management technologies for TBI, most likely requiring FDA clearance. The intent of this focus area is to enable the advancement of candidate technologies to TRL 6 for the objective diagnosis, prognosis, and/or management of TBI. Currently, TBI severity is stratified by Glasgow Coma Scale (GSC)- mild (GCS 14-15), moderate (GCS 9-13), and severe (GCS 3-8); however, a more thorough classification of TBI based on endophenotypic characterization of the injury (neurological exam, imaging, blood-based biomarkers, symptomology, etc.) would provide a more comprehensive picture of the overall injury burden. Additionally, in future combat operations, delayed evacuation times will create a prolonged care scenario that will require TBI casualty management for periods in excess of 24 hours. Examples of these technologies include non-invasive and portable TBI diagnosis and neurocritical care parameter monitoring technology. Potential Funding Availability and Period of Performance (PoP): The USG DoD currently has available the following for the base PoP (PoP1) of up to 24 months: FOCUS AREA #1 (Treatments): Approximately $12 Million (M) FOCUS AREA #2 (Diagnostics): Approximately $9.2 M The maximum request for USG funding for each Solution Brief should not exceed $2.0 million for projects proposing to achieve TRL 5 and $3 million to achieve TRL 6. Cost sharing, including cash and in kind (e.g., personnel or product), contributions are strongly encouraged and have no limit. Additional funding is anticipated for the performer(s) that is selected for the continuation of prototype development to achieve TRL 6 under the subsequent PoP (PoP2) of the resultant award(s), after the Go/No-go Decision Point. MTEC anticipates that one or more awards will be made to qualified Offerors to accomplish the statement of work. It is possible that a single Offeror could receive an award for more than one Focus Area. Project Scope (PoP1 & PoP2) and non-competitive Follow-on Work: The USG and MTEC expect that Offerors’ proposed project scope and maturity will vary based on the initial maturity of the proposed prototype and the ability to meet the solution requirements listed above. Therefore, USG decisions regarding both the rolling down-select and potential non-competitive follow-on work will be based on the advancement in prototype maturity (among other considerations), as it applies to each resultant award(s) during the performance of the prototype project(s). The USG may consider funding any of the following (but not necessarily limited to the) work listed below during any period (i.e., PoP1, PoP2) of the awarded prototype project(s) to include any non-competitive follow on work (which may proceed PoP2 tasks): 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 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: After an In-Process Review (IPR), an evaluation of project deliverables and other considerations to include progress towards completion of the base PoP1 tasks, the Government intends to award a subsequent PoP (PoP2), to the performer(s) that demonstrates a best value approach for follow-on tasks. Award decisions for the subsequent PoP (PoP2) work will be completed during the Go/No-go Decision Point which is expected to occur prior to the end of the base PoP (PoP1). Acquisition Strategy: 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 Solution Brief. The Solution 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 Solution Briefs will also have to address the significant participation of a Nontraditional Defense Contractor or Nonprofit Research Institution 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 Solution Brief, MTEC members who have submitted a favorable Solution 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. MTEC Member Teaming: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to proposal submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. MTEC members are encouraged to use the MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow-up conversations between members as needed. The Collaboration Database Tool can be accessed via the “MTEC Profiles Site” tab on the MTEC members-only website. MTEC: The MTEC mission is to assist the 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: The RPP will be posted to the MTEC website (mtec-sc.org) and a notice will be posted on Contract Opportunities (Beta.SAM.gov) to notify interested parties. MTEC membership is required for the submission of a Solution Brief in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/. For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@officer.mtec-sc.org Sincerely, MTEC Project Team