MTEC Pre-Announcement: Agile Medical Countermeasure Decision Support Tool (AMDST) Prototype

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on the development of a software prototype that will allow a medical planner to assess the residual operational risk for a mission after layering in threat risk, medical countermeasure (MCM) risk-benefit tradeoffs, and fielding risk during mission planning. The AMDST layering model is intended to include all MCMs for a potential threat, including FDA-approved, repurposed, and investigational drugs. One of the goals for AMDST is to make operational planners aware of MCMs in the investigational and repurposed drug pipeline, allowing a demand signal from operations for MCM interim fielding.

Background:

The Defense Threat Reduction Agency (DTRA) Chemical and Biological Technologies Department (RD-CB), in its role as the Joint Science and Technology Office (JSTO) for the Chemical and Biological Defense Program (CBDP), manages a broad portfolio of basic and applied research and advanced technology development activities to support critical chemical and biological (CB) defense missions. Within DTRA RD- CB, the Digital Battlespace Management Division (RD-CBI) provides the warfighter with comprehensive CB data fusion and analytic capabilities to support situational awareness, decision making, and threat management.

Military medical planners require a decision support tool to enable the holistic evaluation of the residual risk to a mission from CB threats after assessing threat agent risk alongside MCM benefits and risks as well as fielding risks (i.e., manufacturing and logistics) of layered MCM strategies, including FDA approved, repurposed and investigational MCMs. This concept is the basis for the Agile MCM Decision Support Tool (AMDST).

AMDST is intended to provide a threat agnostic quantitative risk assessment framework that enables the assessment of key MCMs (vaccines, pre- and post-exposure prophylactics, and therapeutics) relevant to a potential threat, including FDA-approved, repurposed, and investigational MCMs, to allow an operational planner to quantitatively assess an overall residual risk to a mission associated with a CB threat agent alongside benefits and safety of MCMs, and operational relevant to the threat agent.

Ongoing efforts are focused on developing the analytical framework that will power AMDST. The quantitative framework is represented by metric, and submetric scores, which are weighted and organized into a hierarchy of elements underneath three top-level risk and benefit assessment factors. The framework applies to selection and fielding of combinations or layered MCM plans for a mission but does not apply to administration of MCMs to individual warfighters. One of the key outputs of the tool shall be a set of layered MCM plans for a specific mission.

Objective:

The objective of this effort is to develop a decision support software prototype [AMDST] to enable users with a range of expertise to compare operationally relevant risks and benefits of layered MCM plans. AMDST shall facilitate:

• Timely assessment and examination of various layered MCM courses of action (COAs)
• Analysis of risk-benefit tradeoffs during mission planning with CB threat potential
• Allowing a user with limited to no medical knowledge to compare COAs and, as needed, send a demand signal for specific investigational or repurposed MCMs up-the-chain of command
• Provide visualizations of residual risk scores among a set of candidate COAs for the planner to display to a decision maker for MCM planning in response to a mission.
  • Note: The scope of a COA will be limited to pre-planning, staging, and deployment of different MCMs to the battlefield in support of the mission and not on the administration of MCMs into an individual warfighter.

Requirements:

DTRA’s RD-CBI is seeking interdisciplinary teams of performers with both medical expertise and software development experience to address the following requirements:

1. Develop a software application that includes a Graphical User Interface (GUI) capable of:
   1. Supporting threat agnostic risk assessments by allowing end-users to either select standard planning options or input customized settings for various factors (e.g., MCM options, mission characteristics, threat characteristics)
   2. Integrating an existing analytical backbone (algorithm)
   3. Automatically accessing and ingesting gold standard databases with a mechanism that provides for continuous database updates at various periodicities
   4. Incorporating additional, ad hoc, data streams or files, to include authentication and validation of source data
   5. And functioning as a web-based platform via cloud resources/real-time feeds as well as a standalone system that includes built-in data

1. Prototype software is expected to support:
   1. Directing end-user decision making through the generation of both standard and customized reports
   2. Interoperability with other applications through the exchange of data and visualizations

1. AMDST software development shall:
   1. Implement a modular design to allow for maximum flexibility in maintenance, further development, and/or integration with other systems.
   2. Follow an agile development process with incremental software deliveries

Additional Considerations:

Highly competitive proposals will address all objectives and requirements above and demonstrate prior successful experience in prototype development as well as foundational knowledge in current and emerging CB threats, MCMs characteristics, and medical planning. Performer teaming arrangements are encouraged. A successful prototype must be capable of developing software ingestion pipelines to automatically extract relevant medical data from disparate inter- and intra-agency databases. Thus, proposals should discuss data sources and address the feasibility of developing pipelines to automatically extract relevant data into AMDST that will populate the metrics within the backend analytic algorithms powering the front-end GUI and visualizations. Further, proposals should also outline a risk management plan to address any potential technical challenges and proposed solutions in their scientific approach. The selected performer is expected to coordinate with other Government-funded contractors, at the Government sponsor’s direction, to ensure successful data integration into AMDST, and incorporation of end-user feedback through participation in user engagement events and technical interchange meetings.

Potential Funding Availability and Period of Performance:

Offerors are invited to propose budgets that are commensurate with the nature, scope, and complexity of the proposed research. Although the total funding amount for this effort is unspecified, FY24 funds are available for award; the USG may apply additional dollars for subsequent years and/or follow-on efforts via post award modification to any resultant award after the evaluation and acceptance of work and cost plan. Dependent on the results and deliverables, additional time may be added to the period of performance for non-competitive follow-on tasks.

MTEC expects to make a single award to a qualified Offeror to accomplish the scope of work. If a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner. See the “MTEC Member Teaming” section below for more details.

The PoP is not to exceed 36 months. ACQUISITION APPROACH:

This upcoming RPP will be conducted using the Enhanced White Paper approach. In Stage 1, Offerors are invited to submit Enhanced White Papers using the mandatory format contained in this upcoming RPP. The Government will evaluate Enhanced White Papers submitted and select those that best meet their current priorities using the evaluation criteria detailed in the upcoming RPP. Offerors whose proposed solution is selected for further consideration based on the Enhanced White Paper evaluation will be invited to submit a full cost proposal in Stage 2. Notification letters will contain specific Stage 2 proposal submission requirements.

This upcoming RPP will be posted to the MTEC website (mtec-sc.org) and a summary version will be available on SAM.gov to notify interested parties. The RPP is expected to be released as soon as possible and will have a short proposal preparation period (approximately 30 days). MTEC membership is required for the submission of an Enhanced White Paper in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/.

MTEC Member Teaming:

While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to Enhanced White Paper 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. The following resources may help prime contractors provide a more complete team for this requested scope of work.

• The MTEC M-Corps is a network of subject matter experts and service providers to help MTEC members address the business, technical, and regulatory challenges associated with medical product development. M-Corps offers members a wide variety of support services, including but not limited to: Business Expertise [i.e., business development, business and investment planning, cybersecurity, finance, intellectual asset management, legal, logistics/procurement, pitch deck coaching, transaction Advisory], and Technical Expertise [i.e., chemistry, manufacturing and controls (CMC), clinical trials, concepts and requirements development, design development and verification, manufacturing, process validation, manufacturing transfer quality management, regulatory affairs]. Please visit https://www.mtec-sc.org/m-corps/ for details on current partners of the M-Corps.

• 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.

• A dedicated chat forum has been established to facilitate direct interaction amongst MTEC members in relation to this active funding opportunity. The chat forum can be accessed via the “Discuss Portal” on the MTEC members-only website - https://private.mtec-sc.org/.

MTEC:

The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting 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” defense contractors, academic research institutions and not-for-profit organizations.

Point of Contact:

For inquiries regarding this pre-announcement, please direct your correspondence to the MTEC Biomedical Research Associate, Dr. Chuck Hutti, chuck.hutti@ati.org.

Sincerely,

MTEC Project Team