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

Solicitation Number: MTEC-20-15-TBI - 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 announcement for a Request for Project Proposals (RPP) focused on supporting 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 an acute 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 AREAS: 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. This MTEC RPP is aimed at acute diagnostic, therapeutic and management technologies across the spectrum of TBI severities capable of being used in a far-forward operational environment. The USG DoD has identified two focus areas for funding. To meet the intent of this RPP, each Solution Brief MUST specifically address only ONE of the two Focus Areas described below. Offerors are not limited to a 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 FDA-approved therapeutic intervention. 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. Offerors should only propose technology solutions that meet the following two criteria: Currently be at TRL 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. *NOTE: Other points of consideration are described in the RPP, including project maturity, industry partners, cost share, and military impact. POTENTIAL FUNDING AVAILABILITY AND PoP: The USG DoD currently has available the following for the base PoP1 of up to 24 months (18 months or less is preferable): FOCUS AREA #1 (Treatments): Approximately $12 Million FOCUS AREA #2 (Diagnostics): Approximately $9.2 Million The maximum request for Government 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. 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. Additional funding is anticipated for the performer(s) that is selected for the continuation of prototype development under the subsequent PoP (PoP2) of the resultant award(s), after the Go/No-Go Decision Point. SCOPE OF WORK: Scope of Work of Base PoP1 (up to 24 months) The initial, maximum of 24-month base PoP1 should be focused on tasks relevant to advance the prototype to the next 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 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 PoP1, the Government will conduct an in process review (IPR), in which the Awardees will attend and participate in, to assess the work completed for each PoP1 Awardees. 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 down-select represents the Go/No-Go Decision point between PoP1 (base) and PoP2 (subsequent). 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. 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. 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 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: Solution Briefs are due no later than September 1, 2020 at 12:00pm Eastern Time. The RPP is posted to the MTEC website (mtec-sc.org) and a notice is posted on www.beta.SAM.gov to notify interested parties. MTEC membership is required for the submission of a Solution Brief in response to this MTEC RPP. Offerors submitting Solution Briefs as the prime contractor must be MTEC members of good standing by August 27, 2020. 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 USG DoD after the RPP is posted. MTEC Members will be notified when the Proposers Conference is scheduled. 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 this solicitation, click here. Sincerely, MTEC Project Team