Chemical and Biological Defense Program - Dem/Val

Initiate the establishment of disease agnostic clinical Master Protocols and access to clinical trial networks/sites and evaluate digital health technologies in clinical trials.

Continue to support the supply of essential non-clinical testing articles for pre-clinical models on an as needed basis to mitigate a program's pre-clinical timeline.

Transition and further develop organoid development and evaluation technologies to reduce the utilization of non-clinical models.

Initiate a Foundry pilot to accelerate development of CBRN defense capabilities that address the operational needs of U.S. Indo-Pacific Command and demonstrate the value of this integrated experimentation and prototyping concept. Funds the personnel, equipment and other resources required to stand up a “minimum viable product”…

Design and execute rapid experiments for component validation with USINDOPACOM and CBRND unit and other applicable stakeholders for subsystem and component validation, mature concepts of operations and concepts of employment and integrate CBRND experimentation into Combatant Command field exercises. Experimentation efforts funded by this…

Design and build out CUI/SIPR/JWICS-level HPC and AI/ML enabled computing resources for CBRND Bio-Surveillance/Deterrence missions such as global biosurveillance, operational threat assessment, rapid countermeasure development, and chem-bio protective materials. This includes key infrastructure investments for compute and test &…

Optimize manufacturing activities and integration of software with hardware assets. The initiative will provide multiple echelons with real-time understanding of the adversarial threat information left of launch, support and enable Commanders to adopting protective measures, optimize detection and characterization efforts, and ensure…

Conduct preparatory manufacturing runs to lead up to a full end-to-end current Good Manufacturing Production run to demonstrate a 100-day manufacturing capability from sequence to drug product. Conduct Food and Drug Administration (FDA) engagements to determine regulatory pathway for approval of platform technology for drug product…

Continue to develop key starting materials (KSM) and Active Pharmaceutical Ingredients (API) for the stockpile to meet future needs, to include on-shoring key materials to mitigate supply chain risks.

Initiate pre-planning activities to include a system-level tabletop exercise to assess current portfolio readiness and what aspects of the capabilities will be demonstrated and tested in live fire event.

Complete phase 1 clinical studies follow-ups for prototype two, continue clinical studies for prototype three, complete manufacturing and preclinical studies for prototype four and submit Investigational New Drug package to Food and Drug Administration for approval to execute a phase 1 clinical study.

Completed closeout activities from concept development demonstration.

Continue planning, coding, building, and testing new and existing digital tools and corresponding experimental capabilities to increase speed and accuracy of computational medical countermeasure (MCM) discovery efforts to enable rapid response capability. Continue design of new MCMs for transition to the Rapid Access to Products in…

Complete optimization of platform performance, conduct annual exercises to validate platform activity, and prepare for potential transition activities in FY 2028.

Execute current GMP to produce phase 2 compliant doses for use in an emergency situation. Complete non-clinical testing to support Investigational New Drug filing to the FDA. Prepare for phase 1 clinical trial execution.

Complete phase 1a patient follow ups. Transition data products to Rapid Access to Products in Development. Initiate transition of products for potential further clinical evaluation to expand the safety database for use in an emergency situation.

Initiate non-clinical trials in first candidate from industry.

Continue development and manufacturing of multiple vaccine candidates against biothreats. Continue test and evaluation efforts in safety and efficacy clinical trials.

Completed closeout activities from concept development demonstration.

Completed closeout activities from concept development demonstration and continued test planning.

Receive Phase II prototypes and conduct a Soldier Touch Point (STP) and limited government testing. Down select and award a Phase III contract to 1-2 vendor(s) to refine their prototypes further based on test results and feedback. Complete Phase III Contractor Qualification Testing (QT) and receive prototype(s) in preparation for another…

Phase 2 clinical trial completion and execution of drug product manufacturing to support Phase 3 studies.

Initiate non-clinical testing of multiple candidates.

Initiate the evaluation of Host Directed candidates and execute initial non clinical studies.

Initiated drug development, initiated manufacturing and systems engineering.

Continued Natural History Studies with procurement of long lead items and received FDA feedback on the regulatory strategy.

Completed Animal model development and Natural History studies. Due to technical issues with the product in S&T, program is ending in FY25 following receipt of deliverables.

Perform market research and plan for transitioning next capabilities from partner agency.

Continue efforts to produce additional data to better assess detection, protection, and hazard mitigation capabilities against chemical, biological, toxic, and other threats. Conduct workshops on understanding advanced and emerging threat priorities to align with the CBDP. Conduct market surveys and assessments of technologies for rapid…

Perform required testing in coordination with evaluator's to develop modified Commercial Off-The-Shelf (COTS) systems to the warfighter that meet the requirements. This will support Capability Set #2 Milestone C in FY 2028. Continued Program management and administration processes to include but not limited to program oversight, resource…

Continue feature development of CSC2 capabilities, including integration of S&T capabilities for sensor data analytics, non-CBRN sensor data, decision support tools, and data broker capabilities for internal and external data exchanges. Features will be delivered through quarterly software capability releases. This continues the ability…

FFBS Increment 2 will continue prototype development and testing of up to two promising S&T performers under TTA # 26-FFBS-25-001T with a planned down-select to one to enter Engineering and Manufacturing Development (EMD).

Investigate methods to identify toxins, fungi, and agnostic unknown biological threat agents using genomic sequencing. Areas of development will include both wet laboratory protocols and bioinformatics/data analysis. Funds will also cover the quality assurance and quality control of consumables from commercial vendors, to ensure…

Begin developmental testing on prototypes transitioned from Science and Technology (S&T). Complete necessary requirements for successful Milestone A decision planned in fourth quarter FY 2027. Begin Program management and administration processes to include but not limited to program oversight, resource justification, budgeting and…

Continue studies to investigate chemical and biological defense threat pathogenesis and/or pathogenicity models.

FY 2025 efforts supported advanced experimentation activities with joint warfighters to identify CB defense capability gaps across the services. As part of a coordinated experimentation campaign, the program used BA4 to finish development of a joint service algorithm software environment that enables the integration, packaging, and…

Efforts support advanced experimentation activities with joint warfighters to identify CB defense capability gaps across the services. As part of a coordinated experimentation campaign, the program will use BA4 to harden non- and minimally-invasive physiological monitoring software capabilities transitioned from the PM2S program line and…

Funding was awarded for bioinformatics software development, test articles, developmental testing, and a Soldier touchpoint. Funds also supported program labor, office management, and administrative processes to include program oversight, resource justification, budgeting and programming, milestone and schedule tracking.