Warfighter Brain Health (WBH): Late and Long-Term Consequences of Head Impact Exposure and Concussion/Mild Traumatic Brain Injury (mTBI) on Brain Health

The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for a Request for Project Proposals (RPP) for OTA prototype projects focused on determining the relationship between concussion/mild traumatic brain injury (mTBI) and brain health (BH) outcomes through a longitudinal human subject study assessment. BACKGROUND The Department of Defense (DoD) Comprehensive Strategy for Warfighter Brain Health (CSWBH) addresses brain health, brain exposures, to include repetitive head impact exposures, TBI and long-term or late effects, with the goal of optimizing brain health and combating TBI. The DoD's pursuit of superior lethality, per the National Defense Strategy (2018) hinges on the Warfighter's optimal neurocognitive abilities, thus detection and management of brain injury at the time it occurs is paramount. One of the objectives of this strategy is to understand the nature and causes of long-term or late effects of single or repetitive head impact exposures and mTBI/concussion. This remains a significant gap that has stymied translatable knowledge or technology to be conveyed for the benefit of the Warfighter. Several gaps in the existing evidence remain related to the extent by which single and repetitive concussions and/or head impact exposures result in static or progressive changes in brain structure or function and performance. Additionally the need for predictive models to assist in mitigation and prognosis efforts is critical. OVERALL PROGRAM OBJECTIVE The overall objective of the Warfighter Brain Health (WBH) program is to advance both knowledge and technology prototypes (i.e., training, tools, and practice guidelines for assessment, metrics, and interventions) that will reduce or eliminate acute to late and long-term effects from single and repetitive concussion/mTBI. The DoD is seeking Solution Briefs for utilization of an already established and experienced Clinical Research Consortium (CRC) that will follow human subjects who have sustained a single or repeated concussion/mTBI to determine the relationship between concussion/mTBI, head impact exposures and brain health outcomes. The CRC will be expected to interact with a Government Steering Committee with involvement from the USAMRDC and other stakeholders. Solution Briefs submitted in response to this RPP are required to propose an already established and experienced CRC with a proven capability to recruit and maintain study individuals with TBI. Existing study data within the established network with the ability to follow this existing cohort is a requirement. The CRC must include an established network of experts from research, clinical, data management, policy guidance, etc. to meet the intent of this RPP. In addition, desirable capabilities (not listed in order of importance) of the existing CRC infrastructure are that it currently has (at the time of submission of the Solution Brief): The capability to recruit, enroll, and follow a large population of control and TBI patients who have sustained a single or repeated concussion/mTBI (preferably upwards of 15,000 human subjects, if feasible); Access to study populations and data already collected from human subjects that support the goals of this program and the ability to maintain and interpret these data; Ongoing relationships with both non-Government and DoD organizations that comprise the CRC network; Experience with sports- and military-related concussion; Access to military patients with brain trauma including repetitive concussion and/or head impact exposure; Access to human patients with concussion that are part of the National Collegiate Athletic Association (NCAA) [to compare with military patients to build the capability of predictive models and strategies for clinical interventions]; and, The focus to be metric-driven with requirements for prototype development toward clinical interventions, endpoints, policy and processes for mitigation and management of concussion, including the correlation of single and repetitive head impact exposure to Warfighter performance. The end goal of the program is to deliver translatable processes, knowledge and technology (i.e., training, and practice guidelines for assessment and interventions) to better understand, optimize care for, and treat the immediate, long-term and late effects of repetitive head impact exposure (i.e. jump zones, training activities, shipboard, etc.) and single and repetitive concussions/mTBI in order to maximize WBH. It is expected that outcomes will be transitioned to inform practice guidelines, training and clinical trial endpoints. *NOTE: The DoD requires that awardees make TBI research data generated by this award mechanism available to the research community through the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System. Please refer to the full RPP available on MTEC's website (see link below) for more details. POTENTIAL FUNDING AVAILABILITY AND POP The Government expects to have available approximately $25 Million (M) for a period of performance (PoP) for 5 years. Awards resulting from this RPP are expected to be made in Fiscal Year 2021. 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 $25M in Government funding to be provided under the resultant award(s). MTEC anticipates that one award will be made to a qualified Offeror to accomplish the statement of work. Potential non-competitive follow-on work may include tasks related to clinical research with single or repeated concussion/mTBI and clinical trials for concussion/mTBI for therapeutic interventions and/or diagnostic/prognostic technology. ACQUISITION STRATEGY The MTEC will use a streamlined, accelerated approach for this acquisition which will result in Other Transaction (OT) Agreements for prototype projects under the authority of 10 U.S.C. - 2371b. 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 OT 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 full version of the 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 available on MTEC's website (see link below). 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, 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 November 19, 2020 at 12:00pm Eastern Time. The full version of the RPP is posted to the MTEC website (mtec-sc.org); this notice has been posted in order 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 November 16, 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 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 the full length version of the solicitation, please visit MTEC's website at https://www.mtecsc.org/solicitations/