DoD

A potential request for project proposals for technologies such as point-of-care testing, therapeutics, and patient tracking systems.

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a potential Request for Project Proposals (RPP) focused on the development of prototypes aimed to combat the coronavirus (COVID-19).

*CAUTION: All information contained in this pre-announcement has not been formally approved by the Government, and represents MTEC’s interpretation of the situation at this time. All information is subject to change.

PROGRAM BACKGROUND:

In light of the magnitude and potential threat that the coronavirus (COVID-19) poses to our military’s health and readiness, the Government seeks to rapidly accelerate the inquiry, testing, and fielding of new 21st century capabilities, employing novel technologies and approaches to the detection of exposure, prevention, containment and treatment of COVID-19 and future emerging threats.

SOLUTION REQUIREMENTS:

This pre-announcement has been developed by MTEC to provide notice for the possibility of one or more upcoming RPPs focused on combating COVID-19. This notice may also help the membership form appropriate partnerships/teaming relationships so that they are poised to respond to the full requirements described in potential upcoming RPPs. CAUTION: These solution requirements have not been formally established by the Government, and are solely MTEC’s interpretation of the critical needs of the U.S. military.

MTEC believes that an emphasis will be placed on technologies that can be deployed as soon as possible but no later than 31 December 2020. In support of this, MTEC has identified the following potential areas of interest:

• Point-of-care diagnostic that provides rapid and accurate determination on exposure to COVID-19.                         
• Prophylactic(s)/Therapeutic(s) that can prevent and/or treat in a rapid manner (few hours to 2 days) potentially in a non-hospital environment.  Repurposing FDA-approved drugs/biologics for prevention/treatment of COVID-19 or testing of drugs/biologics that have already demonstrated safety in humans for the prevention/treatment of COVID-19 are preferred.
• Disease predictive modeling that provides early warning through data capture from several different streams of data to include social media and artificial intelligence (AI) parameter decision tools that would provide actionable information to medical service providers and command structures.
• Patient monitoring, tracking, and management system for in-home or non-hospital environment patient tele-health services to include interface into the Cerner electronic health record.

POTENTIAL FUNDING:

Although there is no specific funding commitment by the U.S. Government at this time, MTEC believes that there may be tens of millions of dollars available for combating COVID-19 programs with a likelihood of follow-on funding.

ACQUISITION APPROACH:

The MTEC will implement the “Enhanced White Paper” contracting methodology for this potential upcoming RPP(s), which will be an accelerated approach to award. Because of the nature and urgency of the program’s requirements, this streamlined approach is anticipated to be a better means to highlight company methodologies and skills required to address the technical and transition requirements. The Enhanced White Paper process requires extremely quick turnaround times by Offerors. Once the RPP is released, Offerors will be required to submit their Enhanced White Papers within two weeks. Enhanced White Papers will include an abbreviated technical approach, detailed statement of work, and an estimate of cost. All Enhanced White Papers will be provided to the Government for scientific and programmatic relevance evaluation. Upon review of the Enhanced White Papers, several Offerors may be invited for informal discussions with the Government. Offerors who are recommended for award will be required to submit a full cost proposal. MTEC anticipates that awards will be issued within 4-6 weeks of the RPP release date.  Please pay special attention to the upcoming RPP instructions because of the changes that will be made to accommodate the expedited solicitation to award timeframes.

The upcoming RPP(s) will be posted to the MTEC website (mtec-sc.org) and a notice will be posted on www.beta.SAM.gov to notify interested parties. Contingent upon approval from the Government, the upcoming RPP(s) is expected to be released within the next few weeks and will have an extremely short preparation period (approximately 14 days). Due to the critical and urgent nature of the technical topic area, MTEC membership is NOT required for the submission of an enhanced white paper in response to this upcoming MTEC RPP. However, membership will be required for Offerors recommended for award. To join MTEC, please visit http://mtec-sc.org/how-to-join/.

The PRMRP Technology/Therapeutic Development Award is a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into products for clinical applications in one or more Focus Areas published in this funding opportunity for the FY20 PRMRP Topic Areas of Emerging Viral Diseases and/or Respiratory Health. Products in development should be responsive to the healthcare needs of military Service members, Veterans, and/or beneficiaries.

The product(s) to be developed may be a tangible item such as a pharmacologic agent (drugs or biologics) or device, or a knowledge-based product. (A "Knowledge Product" is a non-materiel product that addresses an identified need in a Topic Area, is based on current evidence and research, aims to transition into medical practice, training, tools, or to support materiel solutions [systems to develop, acquire, provide, and sustain medical solutions and capabilities], and educates or impacts behavior throughout the continuum of care, including primary prevention of negative outcomes.) The Principal Investigator (PI) must provide a transition plan (including potential funding and resources, see Attachment 8) showing how the product will progress to the next level of development (e.g., clinical trials, delivery to the military or civilian market) after the completion of the PRMRP award. PIs are encouraged to develop relationships with industry and/or other funding agencies to facilitate moving the product into the next phase of development.

Proof of concept demonstrating the potential utility of the proposed product, or a prototype/ preliminary version of the proposed product, should already be established. Applications must include relevant data that support the rationale for the proposed study. These data may be unpublished and/or from the published literature.

The PRMRP Investigator-Initiated Research Award is intended to support studies that will make an important contribution toward research and/or patient care in one or more Focus Areas published in this Funding Opportunity for the FY20 PRMRP Topic Areas of Emerging Viral Diseases and/or Respiratory Health.

The rationale for a research idea may be derived from a laboratory discovery, population-based studies, a clinician’s first-hand knowledge of patients, or anecdotal data. Applications must include relevant data that support the rationale for the proposed study. These data may be unpublished or from the published literature.

Impact: The Investigator-Initiated Research Award is designed to support research with the potential to yield highly impactful data that could lead to critical discoveries or major advancements. The application must clearly demonstrate the project’s potential short-term and long-term outcome(s)/product(s) (knowledge and/or materiel) and how they will impact a critical problem or question in the field of research and/or patient care in one or more Focus Areas published in this funding opportunity for the FY20 PRMRP Topic Area(s) of Emerging Viral Diseases and/or Respiratory Health.

Research projects may focus on any phase of research from basic laboratory research through translational research, including preclinical studies in animal models and human subjects, as well as correlative studies associated with an existing clinical trial. Research involving human subjects and human anatomical substances is permitted; however, this award may not be used to conduct clinical trials. For more information on how to distinguish clinical research from clinical trials, see the Human Subject Resource Document at https://ebrap.org/eBRAP/public/Program.htm.

As part of the COVID-19 National Response Team's effort to combat COVID-19, the Department of Defense has created this industry portal as a one-stop shop for defense industry, commercial companies and academia to share creative ideas with federal agencies to combat the virus.

All resources and solutions are welcome from industry, academia, venture capital firms, individual contributors and more. Start by using the Request for Information (RFI) form below to share your capability with the team and explore additional resources further down the page.

Mission Focus Areas

1. Combating the Spread (predictive analytics, next hotspot, threat to current activities, decision support, etc.)

2. Welfare of citizens (effects to transportation, movement of people and goods, education and development, physical training, regular HR functions, job transition, etc.)

3. Readiness (continuing operations through the outbreak, coordinating with allies and partners, continuing long term projects, etc.)

4. Logistics (security and protection, supply chain protection and assessment, etc.)

5. Industrial base impacts (small businesses, payments, contracts, large system programs, protection and expansion of critical assets, etc.)

6. Medical (telehealth, medical capacity and sustainment, medical supplies and equipment, etc.)

Review specific urgent needs for the medical category here.

7. Other

The Peer Reviewed Medical Research Program (PRMRP) offers the following three opportunities for Emerging Viral Diseases and Respiratory Health with a focus on COVID-19 research. (1) Clinical Trial Award (W81XWH-20-PRMRP-CTA-COV) - preproposal due June 8, 2020 full proposal due June 22, 2020, (2) Investigator Initiated Research Award (W81XWH-20-PRMRP-IIRA-COV) - preproposal due May 28, 2020 full proposal due June 12, 2020, (3) Technology/Therapeutic Development Award (W81XWH-20-PRMRP-TTDA-COV) - preproposal due May 28, 2020 full proposal due June 12, 2020. Full details are on the CDMRP website.

The Army is looking for information on innovative medical equipment, therapeutics, diagnostics, and vaccines. You must schedule a call for more information (see the website).

Funding for novel conceptual frameworks or theory-based approaches that present disruptive ways of thinking about fundamental scientific problems that have evaded resolution, propose new, paradigm-shifting scientific directions, and/or address fundamental and important questions that are argued to be undervalued by the scientific community. Approaches can include analytical reasoning, calculations, simulations, and thought experiments. While data collection and production are therefore allowed, all supporting data should be generated without the use of laboratory-based experimentation or instrumentation.

The Army has launched a new prize competition, the xTech COVID-19 Ventilator Challenge to help combat the COVID-19 pandemic. The Army is seeking out low-cost, readily manufacturable emergency ventilator to quickly augment ventilator capacity in the exigent COIVID-19 pandemic. The ventilator challenge is open to all US-based entities and is currently accepting applications. Submissions that are approved by the judging panel will receive an invitation to conduct a virtual pitch to a panel beginning on April 13, 2020.