MTEC-20-15-TBI_RPP.pdf

Request for Project Proposals

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”

Issued by:

Advanced Technology International (ATI), MTEC Consortium Manager (CM) 315 Sigma Drive

Summerville, SC 29486 for the

Medical Technology Enterprise Consortium (MTEC)

Request Issue Date: July 30, 2020

Solutions Brief Due Date: September 1, 2020 Noon Eastern Time Zone

White Papers Are NOT Required

Request for Project Proposals MTEC-20-15-TBI Number W81XWH-15-9-0001

Table of Contents 1 Executive Summary

1.1. The Medical Technology Enterprise Consortium

1.2. Purpose

2 Administrative Overview

2.1. Request for Project Proposals (RPP)

2.2. Proposers Conference

2.3. Funding Availability and Type of Funding Instrument Issued

2.4. Acquisition Approach & Rolling Down-Selection

2.5. MTEC Member Teaming

2.6. Proprietary Information

2.7. Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Sharing

2.8. Offeror Eligibility

2.9. Inclusion of Nontraditional Defense Contractors or Nonprofit Research Institutions

2.10. Nontraditional Defense Contractor Definition

2.11. Requirements

2.12. Cost Sharing Definition

2.13. MTEC Assessment Fee

2.14. Intellectual Property

2.15. Data Rights

2.16. Expected Award Date

2.17. Anticipated Solutions Brief Selection Notification

3 Solution Brief

3.1. Solution Brief

3.2. Solution Brief Submission

3.3. Submission Format

4 Solution Brief Preparation Instructions

4.1. General Instructions

5 Technical Requirements

5.1. Introduction

5.2. Technical Focus Area

5.3. Scope of Work

5.4. Restrictions on Animal and Human Subjects:

6 Solution Brief Preparation

6.1. Preparation of the Solution Brief

6.2. Cost Proposal

6.3. Solution Brief and Cost Proposal Preparation Costs

6.4. Freedom of Information Act (FOIA)

7 Selection 8 Points-of-Contact 9 Acronyms/Abbreviations Attachment A: Statement of Work (SOW) Attachment B: Rough Order of Magnitude (ROM) Pricing Attachment C: Technical Addendum for Potential Follow-On Work Attachment D: Technical Addendum for Expansion of Use or Utility (if applicable) Attachment E: IP and Data Rights Attachment F: BIDS Instructions

1 Executive Summary

1.1. The Medical Technology Enterprise Consortium

The Medical Technology Enterprise Consortium (MTEC) is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities, in cooperation with the U.S. Army Medical Research and Development Command (USAMRDC) and other Government agencies in the biomedical sciences (including but not limited to drugs, biologics, vaccines, medical software and medical devices) to protect, treat and optimize the health and performance of U.S. military personnel. MTEC is a nonprofit corporation with the following principal objectives:

(a) biomedical research and prototyping;

(b) exploration of private sector technology opportunities;

(c) technology transfer; and

(d) deployment of intellectual property (IP) and follow-on production.

MTEC is openly recruiting members to join a broad and diverse biomedical consortium that includes representatives from large businesses, small businesses, contract research organizations, “nontraditional” defense contractors, academic research institutions, and not-for-profit organizations; for more information on the MTEC mission, see the Proposal Preparation Guide (PPG) and MTEC website.

MTEC operates under an Other Transaction Agreement (OTA) for prototypes with USAMRDC.

As defined in the OTA Guide dated November 2018, a prototype project addresses a proof of concept, model, reverse engineering to address obsolescence, pilot, novel application of commercial technologies for defense purposes, agile development activity, creation, design, development, demonstration of technical or operational utility, or combinations of the foregoing. A process, including a business process, may be the subject of a prototype project.

Although assistance terms are generally not appropriate in OT agreements, ancillary work efforts that are necessary for completion of the prototype project, such as test site training or limited logistics support, may be included in prototype projects. A prototype may be physical, virtual, or conceptual in nature. A prototype project may be fully funded by DoD, jointly funded by multiple federal agencies, cost-shared, funded in whole or part by third parties, or involve a mutual commitment of resources other than an exchange of funds.

1.2. Purpose

This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International (ATI), represents a Request for Project Proposals (RPP) for MTEC support of the 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 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.

2 Administrative Overview

2.1. Request for Project Proposals (RPP)

Each MTEC Solution Brief submitted must be in accordance with the mandatory format provided in the MTEC PPG, which is available on the Members‐Only MTEC website at www.mtec‐sc.org. White papers are not required for this RPP. The Government reserves the right to award Solution Briefs received from this RPP on a follow-on prototype OTA or other stand-alone OTAs as necessary to meet mission requirements.

2.2. Proposers Conference

MTEC will host a Proposers Conference within two weeks after the release of the RPP that will be conducted via webinar. Further instructions will be forthcoming via email. Offerors are advised to check the MTEC website periodically during the proposal preparation period for any clarifications found in Frequently Asked Questions (FAQ) responses.

2.3. Funding Availability and Type of Funding Instrument Issued The Government currently has available the following for the base period of performance (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 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.

http://www.mtec‐sc.org/

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. Note, however, that as of the release date of this RPP, future year Defense Appropriations Bills have not been passed and there is no guarantee that any additional funds will be made available to support this program. The funding estimated for this RPP is approximate and subject to realignment. Funding of proposals received in response to this RPP is contingent upon the availability of federal funds for this program. The Government reserves the right to reduce the scope/funding of the subsequent PoP (PoP2) for the continuation of prototype development as part of the rolling down-select, if the Offeror's technology after the initial base period (PoP1) excels only in a limited number of the solutions requirements detailed in Section 6 of this RPP. Furthermore, the Government reserves the right to encourage teaming arrangements between any or all of the base PoP (PoP1) awardees/performers to collaborate in the subsequent PoP award phase (PoP2) to maximize performance across the greatest number of the solutions requirements, and may allocate the subsequent PoP funds in accordance with participation in such a collaboration.

Award funding will be structured incrementally and based upon the completion of milestones.

2.4. Acquisition Approach & Rolling Down-Selection

This RPP will be conducted using a multi-staged approach. In Stage 1, current MTEC members are invited to submit Solution Briefs using the mandatory format contained in this RPP (see Section 6 of this RPP). The Government will evaluate Solution Briefs submitted and will select the Solution Briefs that best meet their current technology priorities using the criteria in Section 7 of this RPP. Offerors whose proposed solution is selected for further consideration based on the Solution Brief evaluation will be invited to submit a “pitch” in Stage 2. Notification letters will contain specific Stage 2 proposal submission requirements. See Section 6 below for additional details regarding the Stage 2 solicitation process.

Offerors are hereby notified that the Government intends to utilize a rolling down-select approach during the performance of prototype projects awarded as a result of this RPP. Using this approach, the intends to award projects, structured into two different Periods of Performance (PoPs), with an initial base period (PoP1) (see period of performance and funding details under Section 1.7 below) reflecting the first of the two PoPs. After an In-Process Review (IPR), an evaluation of project deliverables and other considerations to include progress towards completion of the base PoP tasks, the Government intends to award a second PoP, referred to as the 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) (tentatively projected to occur 20 months into PoP1). See the proposal format requirements and instructions to Offerors detailed under Section 6 (“Technical Requirements”) of this RPP for additional details.

The Government reserves the right to end all awarded projects after the initial base period and award no subsequent PoP tasks depending on project outcomes, availability of funding, and changing Government requirements. Additionally, the Government reserves the right to negotiate with performers (selected for award under this RPP), on a noncompetitive basis, to award additional scope to successful projects. While this is anticipated to occur after the subsequent PoP (PoP2), this may occur at any time following award of OTA for prototype projects.

Pending successful completion of the total effort, the Government may issue a non-competitive follow-on production contract or transaction pursuant to 10 USC 2371b section f.

The Government-selected Research Project Awards will be funded under the Other Transaction Agreement for prototype projects (OTA) Number W81XWH-15-9-0001 with MTEC administered by the CM, ATI. The CM will negotiate and execute a Base Agreement with MTEC members (if not yet executed). The same provisions will govern this Base Agreement as the OTA for prototype projects between the Government and MTEC. Subsequently, any proposal that is selected for award will be funded through a Research Project Award issued under the member’s Base Agreement. A sample of the MTEC Base Agreement can be found on the MTEC website and Members-Only website at www.mtec-sc.org.

At the time of the submission, if Offerors have not yet executed a Base Agreement, then Offerors must certify on the cover page of their Solution Brief that, if selected for award, they will abide by the terms and conditions of the latest version of the MTEC Base Agreement. If the Offeror already has executed an MTEC Base Agreement with the MTEC CM, then the Offeror must state on the cover page of its Solution Brief that, if selected for award, it anticipates the proposed effort will be funded under its executed MTEC Base Agreement.

2.5. MTEC Member Teaming

While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to Solution Brief 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. The purpose of the tool is to help MTEC member organizations identify potential teaming partners by providing a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, Research and Development (R&D) highlights/projects, and technical expertise. The Primary Point of Contact for each member organization is provided access to the collaboration database tool to make edits and populate their organization’s profile. There are two sections as part of the profile relevant to teaming:

“Collaboration Interests” - Select the type of teaming opportunities your organization would be interested in. This information is crucial when organizations need to search http://www.mtec-sc.org/ the membership for specific capabilities/expertise that other members are willing to offer.

“Solicitation Collaboration Interests” - Input specific active solicitations that you are interested in teaming on. This information will help organizations interested in a specific funding opportunities identify others that are interested to partner in regards to the same funding opportunity. 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 can be accessed via the “MTEC Profiles Site” tab on the MTEC members-only website.

2.6. Proprietary Information

The MTEC CM will oversee submission of Solution Briefs submitted in response to this RPP. The MTEC CM shall take the necessary steps to protect all proprietary information and shall not use such proprietary information for purposes other than the evaluation of an Offeror’s Solution Brief and the subsequent agreement administration if the Solution Brief is selected for award.

In accordance with the PPG, please mark all Confidential or Proprietary Information as such. An Offeror’s submission of a Solution Brief under this RPP indicates concurrence with the aforementioned CM responsibilities.

Also, as part of MTEC’s mission to incorporate philanthropic donations, MTEC frequently makes contact with private entities (e.g., foundations, investor groups, organizations, individuals) that award grants or otherwise co-fund research, and/or operates in research areas that are aligned with those of MTEC. These private entities may be interested in reviewing certain Proposals within their program areas, allowing opportunities to attract supplemental funding sources. On your Proposal Cover Page, please indicate your willingness to allow MTEC Officers and Directors access to your Proposal for the purposes of engaging in outreach activities with these private organizations. MTEC Officers and Directors granted Proposal access have signed Non-disclosure Agreements (NDAs) and Organizational Conflict of Interest (OCI) statements. Additionally, all Technical Evaluation Panel participants will agree to, and sign a nonproprietary information and a conflict of interest document.

2.7. Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Sharing The DoD requires that awardees make TBI research data generated by this award mechanism available to the research community through the FITBIR Informatics System. The FITBIR Informatics System is a free resource designed to accelerate research progress by allowing the storage, re-analysis, integration, and rigorous comparison of multiple datasets. Currently FITBIR eligible research include all studies generating prospectively collected human TBI subject data (e.g., clinical, demographic, phenotypic, imaging, and genomic).

Data reporting to FITBIR is an opportunity for investigators to facilitate their own research and to collaborate with others engaged in similar research. While there is no direct charge to users of the FITBIR Informatics System, a project estimation tool (https://fitbir.nih.gov/jsp/contribute/fitbir-costs.jsp) is available to help estimate costs and manpower needs that may be associated with data submission. FITBIR guidance and policies, as well as the considerable advantages of FITBIR participation to the researcher, are detailed at http://fitbir.nih.gov/.

In order to share data with FITBIR, three elements must be included in the proposed research:

1. Updated informed consent language that includes FITBIR data sharing. Sample consent language is included in Appendix III.

2. Global Unique Identifier (GUID): FITBIR encourages collaboration between laboratories, as well as interconnectivity with other informatics platforms. Such community-wide sharing requires common data definitions and standards. FITBIR allows for de-identification and storage of data (medical imaging clinical assessment, environmental and behavioral history, etc.) of various types (text, numeric, image, time series, etc.).

Use of FITBIR’s GUID system facilitates repeated and multi-user access to data without the need to personally identify data sources. In order to generate a GUID for a subject, the following personally identifiable information (PII) must be collected in the proposed research:

a. Complete legal given (first) name of subject at birth

b. Complete legal additional name of subject at birth (if subject has a middle name)

c. Complete legal family (last) name of subject at birth

d. Day of birth

e. Month of birth

f. Year of birth

g. Name of city/municipality in which subject was born

h. Country of birth

Note that this PII is never sent to the FITBIR system. PII cannot be extracted from the GUID.

Information on GUID compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations can be found at https://fitbir.nih.gov/content/global-unique-identifier.

3. Common Data Elements (CDEs): Research data elements must be reported using the National Institute of Neurological Disorders and Stroke (NINDS) TBI CDEs or entered into the FITBIR data dictionary as new, unique data elements (UDEs). For the most current version of the NINDS TBI CDEs, go to http://www.commondataelements.ninds.nih.gov.

Assistance will be available to help the researchers map their study variables to specific CDEs and ensure the formats of the CDEs collected are compatible with the FITBIR Informatics System. Use of the TBI CDEs is required wherever possible in an effort to create standardized definitions and guidelines about the kinds of data to collect and the https://fitbir.nih.gov/jsp/contribute/fitbir-costs.jsp http://fitbir.nih.gov/ https://fitbir.nih.gov/content/global-unique-identifier http://www.commondataelements.ninds.nih.gov/ data collection methods that should be used in clinical studies of TBI. Use of UDEs is strongly discouraged and subject to program approval.

2.8. Offeror Eligibility

Offerors must be MTEC Members in good standing. Offerors submitting Solution Briefs as the prime contractor must be MTEC members of good standing by August 27, 2020.

2.9. Inclusion of Nontraditional Defense Contractors or Nonprofit Research Institutions Proposals that do not include Nontraditional Defense Contractor or Nonprofit Research Institution participation to a significant extent, or do not propose at least one third acceptable cost sharing, will not be eligible for award.

This requirement is a statutory element of the Other Transaction Authority. Please see the MTEC PPG and RPP (Section 5) for additional details.

2.10. Nontraditional Defense Contractor Definition

A nontraditional defense contractor is a business unit that has not, for a period of at least one year prior to the issue date of the Request for Project Proposals, entered into or performed on any contract or subcontract that is subject to full coverage under the cost accounting standards (CAS) prescribed pursuant to section 26 of the Office of Federal Procurement Policy Act (41 U.S.C. 422) and the regulations implementing such section.

2.11. Requirements

Research Projects selected for funding under this RPP are required to meet at least one of the following conditions:

Have at least one nontraditional defense contractor or nonprofit research institution participating to a significant extent

All significant participants other than the Federal Government are small businesses (including small businesses participating in a program described under section 9 of the Small Business Act (15 U.S.C 638).

Provide at least 1/3 of the Research Project cost as cost share.

Beyond that, cost sharing is encouraged if possible, as it leads to stronger leveraging of Government-Contractor collaboration.

If the Offeror asserts either (1) it is a nontraditional defense contractor or (2) proposes a nontraditional defense contractor as a team member/subcontractor, the Offeror shall submit Warranties and Representations (see PPG) specifying the critical technologies being offered and/or the significant extent of participation of the nontraditional defense contractor. The nontraditional defense contractor can be an individual so long as he/she has a DUNS Number and meets the requirements in the Warranties and Representations. The significance of the nontraditional defense contractor’s participation must be explained in detail in the signed Warranties and Representations. Inadequate detail can cause delay in award.

Per the DoD OT Guide, rationale to justify a significant contribution include:

a. Supplying a new key technology, product or process;

b. Supplying a novel application or approach to an existing technology, product or process;

c. Providing a material increase in the performance, efficiency, quality or versatility of a key technology, product or process;

d. Accomplishing a significant amount of the prototype project;

e. Causing a material reduction in the cost or schedule of the prototype project;

and,

f. Provide for a material increase in performance of the prototype project

2.12. Cost Sharing Definition

Cost sharing is defined as the resources expended by the award recipients on the proposed statement of work (SOW). If cost sharing is proposed, then the Offeror shall state the amount that is being proposed and whether the cost sharing is a cash contribution or in-kind contribution; provide a description of each cost share item proposed; the proposed dollar amount for each cost share item proposed; and the valuation technique used (e.g., vendor quote, historical cost, labor hours and labor rates, number of trips, etc.). Cost sharing is encouraged if possible, as it leads to stronger leveraging of Government-contractor collaboration.

Cash Contribution Cash Contribution means the Consortium and/or the Research Project Awardee (or Awardees' lower tier sub-awards) financial resources expended to perform a Research Project. The cash contribution may be derived from the Consortium's or Research Project Awardee (or Awardees' sub-awards) funds or outside sources or from nonfederal contract or grant revenues or from profit or fee on a federal procurement contract.

An Offeror’s own source of funds may include corporate retained earnings, current or prospective Independent Research and Development (IR&D) funds or any other indirect cost pool allocation. New or concurrent IR&D funds may be utilized as a cash contribution provided those funds identified by the Offeror will be spent on performance of the SOW of a Research Project or specific tasks identified within the SOW of a Research Project. Prior IR&D funds will not be considered as part of the Offeror's cash.

Cash contributions include the funds the Offeror will spend for labor (including benefits and direct overhead), materials, new equipment (prorated if appropriate), awardees' sub-award efforts expended on the SOW of a Research Project, and restocking the parts and material consumed.

In-Kind Contribution In Kind Contribution means the Offeror’s non-financial resources expended by the Consortium Members to perform a Research Project such as wear-and-tear on in-place capital assets like machinery or the prorated value of space used for performance of the Research Project, and the reasonable fair market value (appropriately prorated) of equipment, materials, IP, and other property used in the performance of the SOW of the Research Project.

Prior IR&D funds will not be considered as part of the Consortium Member's cash or In-Kind contributions, except when using the same procedures as those that authorize Pre-Award Costs, nor will fees be considered on a Consortium Member's cost sharing portion.

See the MTEC PPG for additional details. If the offer contains multiple team members, this information shall be provided for each team member providing cost share.

2.13. MTEC Assessment Fee

Per Section 3.4 of the Consortium Member Agreement (CMA), each recipient of a Research Project Award under the MTEC OTA shall pay MTEC an amount equal to 1% of the total funded value of each research project awarded. Such deposits shall be due no later than 90-days after the research project award is executed. Awardees are not allowed to use MTEC funding to pay for their assessment fees.

2.14. Intellectual Property

Intellectual Property (IP) rights for MTEC Research Project Awards will be defined in the terms of an awardee’s Base Agreement and resultant Task Orders. MTEC reserves the right to assist in the negotiation of IP, royalties, licensing, future development, etc., between the Government and the individual performers during the entire award period.

Additionally, MTEC has established two methods of payment to be made to MTEC surrounding the licensing/commercialization of Intellectual Property developed with funding received from MTEC Research Project Awards:

Royalty Payment Agreements Government-funded research projects awarded through MTEC will be subject to a 10% royalty on all Net Revenues received by the Research Project Award recipient resulting from the licensing/commercialization of the technology, capped at 200% of the Government funding provided.

Additional Research Project Award Assessment In lieu of providing the royalty payment agreement described above, members receiving Research Project Awards may elect to pay an additional assessment of 2% above the standard assessment percentage described in Section 3.4 of the CMA. This additional assessment applies to all research project awards, whether the award is Government funded or privately funded.

2.15. Data Rights

The Offeror shall comply with the terms and conditions defined in the Base Agreement regarding Data Rights. It is anticipated that anything delivered under this proposed effort would be delivered to the Government with unlimited data rights unless otherwise asserted in the proposal and agreed to by the Government. Rights in technical data in each Research Project Award shall be determined in accordance with the provisions of MTEC Base Agreement.

See Attachment E for more detail.

2.16. Expected Award Date

Offeror should plan on the period of performance beginning May 1, 2021 (subject to change).

The Government reserves the right to change the proposed period of performance start date through negotiations via the CM and prior to issuing a Research Project Award.

2.17. Anticipated Solutions Brief Selection Notification

As the basis of selections is completed, the Government will forward their selections to the MTEC CM to notify Offerors. Proposers will be notified by letter from the MTEC of the results of the evaluation. Those successful will move forward to the next phase of solution brief pitch while those rejected will gain evaluation rationale for non-selection.

3 Solution Brief

3.1. Solution Brief

The MTEC will use a streamlined, interactive approach for this RPP. Because of the nature of the requirements set forth in this RPP, this streamlined, interactive approach is anticipated to be a better means to highlight company methodologies and skills that should 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 the Offeror would approach and solve such an action. The following sections describe the formats and requirements of the Solution Brief.

Offerors who submit Solution Briefs in response to this RPP must submit by the date on the cover page of this RPP. Solution Briefs received after the time and date specified will not be evaluated.

3.2. Solution Brief Submission

Solution Briefs shall be submitted by the date and time specified on the cover page using BIDS:

https://ati2.acqcenter.com/ATI2/Portal.nsf/Start?ReadForm. Include the MTEC-20-15-TBI Solicitation Number on each Solution Brief submitted. See RPP Attachment F for further information regarding BIDS registration and submission.

Do not submit any classified information in the Solution Brief submission.

3.3. Submission Format

Offerors should submit files in Microsoft Office formats or Adobe Acrobat (PDF – portable document format) as indicated below. ZIP files and other application formats are not acceptable. All files must be print-capable and without a password required. Filenames must contain the appropriate filename extension (.docx, .doc, .pptx, .ppt .xlsx, .xls or .pdf). Filenames should not contain special characters. Apple users must ensure the entire filename and path are free of spaces and special characters.

MTEC will email receipt confirmations to Offerors upon submission. Offerors may submit in advance of the deadline. Neither MTEC nor ATI will make allowances/exceptions for submission problems encountered by the Offeror using system-to-system interfaces. If the Offeror receives errors and fails to upload the full submission prior to the submission deadline, the submission will not be accepted. It is the Offeror’s responsibility to ensure a timely and complete submission.

4 Solution Brief Preparation Instructions

4.1. General Instructions

The Solution Brief and Cost Proposal format provided in this MTEC RPP are mandatory and shall reference this RPP number (MTEC-20-15-TBI). Offerors are encouraged to contact the Point-of- Contact (POC) identified herein up until the Solution Brief submission date/time to clarify requirements.

All eligible Offerors may submit Solution Briefs for evaluation according to the criteria set forth herein. Offerors are advised that only ATI as the MTEC’s CM, with the approval of the DoD Agreements Officer, is legally authorized to contractually bind or otherwise commit funding for selected awards as result of this RPP.

https://ati2.acqcenter.com/ATI2/Portal.nsf/Start?ReadForm

5 Technical Requirements

5.1. Introduction

Current wartime operations assume that the United States and our allies will maintain air, land, maritime, space and cyber superiority. Future conflicts against peer and near-peer adversaries are expected to be layered stand-offs, fought across multiple domains (Multi-Domain Operations, MDO). Mission success will be determined by our ability to compete to expand the competitive space, penetrate both strategic and operationally, disintegrate enemy’s defenses, exploit enemy weaknesses and re-compete to consolidate gains. Medical plays a critical role in each aspect of MDO and must modernize rapidly to maintain Force readiness and increase soldier lethality. Diagnosis, treatment, monitoring, and maintenance of TBI casualties in the acute setting can significantly improve long-term functional outcomes and reduce injury severity. Development of diagnosis and treatment interventions to reduce injury severity and improve casualty maintenance that can be employed at Role 1 (far-forward medical care), over the course of the subsequent 1-3 days following injury, will facilitate reductions in permanent brain damage, better Warfighter care and improved return-to-duty times.

For additional information on JPC-6/CCCRP, the program’s previous and current successes, and other documents related to the program’s long-term planning efforts, please visit the CCCRP official website at https://ccc.amedd.army.mil/Pages/default.aspx

5.2. 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. 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 CCCRP 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 https://ccc.amedd.army.mil/Pages/default.aspx 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:

1. Currently be at Technology Readiness Level (TRL) of 4 or 5 [definition of TRLs – https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf]; and,

2. Currently be in development or commercially available.

Additional points of consideration:

Project Maturity: This solicitation is not meant to support development of a new prototype, but should focus on fine-tuning and optimization of existing prototypes or other technologies. [NOTE: This RPP allows for proposed solutions to be currently at TRL 4 of 5 at the time of submission. It is the goal that proposed projects should achieve TRL https://tracktbinet.ucsf.edu/ https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf

6 by the end of the total program (which may include potential follow-on funding and PoP beyond the initial base PoP of 24 months (Phase 1)).]

Industry Partners: It is expected that the eventual goal of projects funded by this RPP will transition to organizations for the preparation for (e.g., advanced development of the prototype) and execution of Phase 2 clinical trials with the ultimate goal to reach market. While not a requirement, Offerors are strongly encouraged to include industry partnerships as appropriate.

Cost Share: The Government funds provided for this initiative are not anticipated to be the sole funding resource for the efforts. Because the RPP is focused on prototyping activities, rather than basic science and discovery, it is anticipated that the Government funds would provide incentive for industry funding to join the project. While not a requirement, Offerors are strongly encouraged to include Cost Share as appropriate.

Military Impact: Priority will be given to technologies that can be utilized for all injury severities and can be scaled to fit the needs of DoD. Offerors need to demonstrate the capability to complete TRL 6 with an appreciation of the military and commercial markets for TBI interventions, and demonstrate an understanding of the military need for far forward diagnostic and therapeutic interventions for TBI.

5.3. Scope of Work

Scope 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 PoP (tentatively projected to occur 20 months into 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).

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 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 during 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.

5.4. Restrictions on Animal and Human Subjects:

Solution Briefs must comply with restrictions and reporting requirements for the use of animal and human subjects, to include research involving the secondary use of human biospecimens and/or human data. The Awardee shall ensure local Institutional Animal Care and Use Committee (IACUC) and Institutional Review Board (IRB) approvals, continuing review (in the intervals specified by the local IACUC and IRB, but at a minimum, annually), and approval by the U.S. Army Animal Use and Review Office (ACURO) and U.S. Army Human Research Protections Office (HRPO). Offerors shall include IACUC, ACURO, IRB and HRPO review and approval in the SOW/Milestones Table submitted with the Solution Brief Pitch.

These restrictions include mandatory Government review and reporting processes that will impact the Offeror’s schedule.

For example, the clinical studies under this RPP shall not begin until the USAMRDC Office of Research Protections (ORP) provides authorization that the research may proceed. The USAMRDC ORP will issue written approval to begin research under separate notification.

Written approval to proceed from the USAMRDC ORP is also required for any Research Project Awardee (or lower tier sub-awards) that will use funds from this award to conduct research involving human subjects. Offerors must allow at least 60 days in their schedule for the ORP review and authorization process.

6 Solution Brief Preparation

6.1. Preparation of the Solution Brief

Offerors submitting Solution Briefs in response to this RPP will be required to submit using the following steps outlined below:

Step 1: Solution Brief

Required Submission Documents (1): Submitted via BIDS

Solution Brief: One PDF document 5MB or lower.

The Offeror will submit a Solution Brief, which describes the overall technical concept and approach along with the viability toward the Offeror’s specific effort. The following sections must be included in the Solution Brief:

Cover Page (included in the page limit) must include the following information:

o Title of Solution Brief o Offeror’s name and contact information (such as name of the organization, point of contact’s name, email address, phone number, mailing address, etc.)

o Statement that “This Solution Brief is submitted pursuant to the RPP MTEC-20-

15-TBI”

o Indicate which Focus Area this proposal is addressing (only 1 focus area may be selected per Solution Brief):

Focus Area #1: Treatments Focus Area #2: Diagnostics o Dates of submission and signature of official authorized to obligate the institution contractually o Willingness to allow MTEC Officers access to your Solution Brief for the purposes of engaging in outreach activities with private sector entities: Indicate YES or NO [As part of MTEC’s mission to incorporate philanthropic donations, MTEC frequently makes contact with private sector entities (e.g., foundations, organizations, individuals) that award grants or otherwise co-fund research, and/or operate in research areas that are aligned with those of MTEC. Additional private entities may be interested in reviewing certain Solution Briefs and Cost Proposals within their program areas, allowing opportunities to attract supplemental funding sources. Please indicate your willingness to allow MTEC access to your Solution Brief for the purposes of engaging in outreach activities with these private sector entities. MTEC staff has signed NDAs and OCI statements.]

Approach: [Briefly describe your approach to solving the problem. Include relevant background data about your approach. Describe the existing technology, including the TRL. Note: References are included within the page limit. There is no required format for the inclusion of references.]

Objectives: [Specify the objectives of the proposed effort for the base PoP1 of up to 24-months.]

Technical Strategy: [Outline the proposed methodology for the base PoP1 of up to 24-months by task in sufficient detail to show a clear course of action that addresses the technical requirements described in this RPP.]

Anticipated Outcomes: [Provide a description of the anticipated outcomes from the proposed work. List milestones and deliverables from the proposed work.]

Regulatory Pathway: [Provide a brief description of the anticipated regulatory pathway for the base PoP1 and proposed follow-on work to achieve TRL 6.]

Commercialization Strategy: [Provide a brief description of the commercialization plans.]

Military Impact: [Offeror should demonstrate an appreciation of the DoD and demonstrate an understanding of the DoD need for far-forward diagnostic and therapeutic interventions for TBI.]

Participants: [Briefly state the qualifications of the Principal Investigator, key personnel, and organizations that will perform the SOW proposed in the base PoP1.]

Base POP: [Indicate the proposed base PoP1. Provide an estimated Gantt Chart of the major activities proposed.]

Project Management Plan: [The Solution Brief shall describe the overall project management plan.]

Cost Share: [It is anticipated that Government funds would provide incentive for industry funding to join the project. While not a requirement, Offerors are strongly encouraged to discuss the ability to bring leveraged funding/cost share to complete the project goals.]

Non-traditional defense contractor, nonprofit research institution, or 1/3 cost sharing:

[Describe the plan to include significant participation of a non-traditional defense contractor, nonprofit research institution, or the ability to meet 1/3 cost sharing requirement. Refer to Sections 2.5-2.8 for more information.]

Rough Order of Magnitude (ROM) Pricing: [Refer to Attachment B.]

Technical Addendum for Potential Follow-On Work for PoP2: [Refer to Attachment C, limited to three pages, included in the 15 page Solution Brief page limitation. This technical addendum is a critical component of the Solution Brief submission. Please provide a well-thought out response. This addendum should be indicative of the work that you propose to conduct in PoP2.]

Technical Addendum for Expansion of Use or Utility (if applicable): [Refer to Attachment D, limited to two pages, included in the 15 page Solution Brief page limitation. This technical addendum is a critical component of the Solution Brief submission. Please provide a well-thought out response.]

IP and Data Rights: [Refer to Attachment E, included in the 15 page Solution Brief page limitation. IP and data rights are a critical component of the Solution Brief submission.

Please provide a well-thought out response.]

The Solution Brief is limited to fifteen pages (including cover page), 12 point font (or larger), Single-spaced, single-sided, 8.5 inches x 11 inches). Smaller type may be used in figures and tables, but must be clearly legible. Margins on all sides (top, bottom, left, and right) should be at least 0.5 inch. Solution Briefs exceeding the 15-page limit will not be accepted.

Solution Brief Evaluation:

The CM will distribute all Solution Briefs to the Government for evaluation. The Government will evaluate and determine which proposal(s) to award based on the following criteria:

Factor 1 – Technical Feasibility: Feasibility of the proposed solution and its alignment with the RPP’s topic area, including access to human subject population if applicable.

Factor 2 – Potential for Transition: Soundness of regulatory strategy and potential to achieve TRL 6 with success. Military impact will also be considered as part of this factor.

Factor 3 – Project Team: Strength of the organization/team proposed to complete the work and its financial stability to potentially continue the maturation of the system beyond the scope of this RPP. Includes experience with animal research for IND, and human research, study population recruitment and sustainment.

Factor 4 – Cost/Price: Estimated ROM costs represent reasonable value for proposed solution offered.

Factor 5 – OTA Compliance Requirement: Inclusion of nontraditional or small business participation, nonprofit research institution, or a 1/3 cost share.

Upon review of the Solution Briefs, Offerors may be invited into Step 2 of the Solution Brief process. Offerors who are not invited to proceed into Step 2 will be provided feedback.

Step 2: Solution Brief Pitch:

Required Submission Documents (2): Submitted via BIDS

Solution Brief Pitch: One PDF document 5MB or lower.