MTEC Solicitation Summary: Agile Medical Countermeasure Decision Support Tool (AMDST) Prototype

The Medical Technology Enterprise Consortium (MTEC) is excited to post the Request for Project Proposals (RPP) for MTEC-24-04-AMDST 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 Agile Medical Countermeasure Decision Support Tool (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. As stated at the end of this announcement, the full RPP is posted to the MTEC website (mtec-sc.org); this notice is intended only to notify interested parties of the available solicitation. 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 by assessing threat agent risk, alongside MCM benefits and risks as well as timely fielding risks of layered MCM strategies, including Food and Drug Administration (FDA) approved, repurposed and investigational MCMs. This concept is the basis for the 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 drugs 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. Solution Requirements: DTRA’s RD-CBI is seeking interdisciplinary teams of performers with both medical expertise and software development experience to address the following requirements: Develop a software application that includes a Graphical User Interface (GUI) capable of: 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) Converting and integrating an existing Excel- and MATLAB-based analytical framework into an open source programming language (e.g., R, Python) Automatically accessing and ingesting gold standard databases with a mechanism that provides for continuous database updates at various periodicities; databases, file formats, and their respective periodicities will be determined in coordination with DTRA Incorporating additional, ad hoc, data streams or files, to include verification of source data Functioning as a web-based platform via GovCloud resources/real-time feeds as well as a standalone system that includes built-in data Ensuring user-based access is secured in accordance with DoD Development, Security, and Operations (DEVSECOPS) standards (e.g., two-factor or CAC-enabled authentication) Prototype software is expected to support: Direct end-user decision making through the generation of both standard and customized reports, which will be formatted and designed in coordination with RD-CBI and end-users Interoperability with other systems/applications through the exchange of data and visualizations (e.g., Discovery of Medical Countermeasures Against New and Emerging threats (DOMANE), Algorithm Generator to Explore Novel Threats Leveraging the Rapid AI Platform for Innovating Data Science (AGENT-RAPIDS), Rapid Access to Products in Development (RAPID)) AMDST software development shall: Implement a modular design to allow for maximum flexibility in maintenance, further development, and/or integration with other systems/applications as noted above Follow an agile development process with incremental software deliveries and incorporation of Continuous Integration/Continuous Development (CI/CD) processes Additional Considerations: Highly competitive proposals will address all of the 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 database. 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 Member 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. It is the intent that a contractual relationship with other Government-funded contractors would be executed under the MTEC OTA. Interested parties are encouraged to review the MTEC Base Agreement, which includes the overarching terms and conditions from the OTA for prototype projects between the Government and MTEC that all Research Project Awardees are expected to agree to. The MTEC Base Agreement can be found on the MTEC Website (within the Documents Library: https://www.mtec-sc.org/documents-library/) and the Members-Only website at www.mtecsc.org. Potential Follow-on Tasks: Under awards resulting from this RPP, there is the potential for award of one or more non-competitive follow-on tasks based on the success of the project (subject to change depending upon Government review of completed work and successful progression of milestones). Potential follow-on work may be awarded based on the advancement in prototype maturity during the PoP. Offerors are encouraged, as appropriate, to discuss potential follow-on work in the Enhanced White Paper submission to demonstrate the ability to further advance the project maturity beyond the proposed PoP. This will also allow the Offeror to highlight the potential capabilities that can be explored/achieved through short term and/or long-term advancement of the project in a way that is beneficial to the Government. 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 RPP will be conducted using the Enhanced White Paper approach. In Stage 1, current MTEC members are invited to submit Enhanced White Papers using the mandatory format contained in the RPP. The Government will evaluate Enhanced White Papers submitted and will select those that best meet their current technology priorities using the criteria listed in the 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. Proposers Conference : A proposers conference for this effort will be held via Zoom on Wednesday January 24, 2024, at 2PM EST. The MTEC proposers conference is a virtual webinar that provides potential Offerors the opportunity to interact directly with both MTEC and the Government Sponsors related to the information in this RPP. The flow for this conference will be as follows. First, MTEC will provide an administrative overview of the solicitation. Second, representatives from the Defense Threat Reduction Agency (DTRA) will then provide an overview of the technical requirements of this effort. Finally, all attendees are invited to anonymously type questions into the webinar’s Q&A function, which are answered verbally and live by the appropriate presenter from MTEC or the sponsor. Please use the following link to register for the conference to be held on Wednesday January 24, 2024, at 2PM EST : https://ati.zoomgov.com/webinar/register/WN_9Q0Rj7VsThet2aUh1MYVmw 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, please direct your correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator, [email protected] Technical and membership questions should be directed to the MTEC Research Associate, Dr. Chuck Hutti, Ph.D., [email protected] All other questions should be directed to the MTEC Program Director, Mr. Evan Kellinger, [email protected] To view the full length version of this solicitation, visit www.mtec-sc.org/solicitations/.