Enabling Investments (ACD&P)

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…

FY2027 planned work 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 program in FY 2027 will primarily support material capability development required for biological deterrence in USINDOPACOM.

FY2026 to FY2027 change Increased investment focuses and expands existing experimentation and prototyping efforts toward priority Areas of Responsibility (AoR).

FY2027 planned work 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” experimentation enabler that supports the Enterprise’s capability development efforts.

FY2026 to FY2027 change CBRNDEX focuses and expands existing experimentation and prototyping efforts.

FY2027 planned work Initiate the establishment of disease agnostic clinical Master Protocols and access to clinical trial networks/sites and evaluate digital health technologies in clinical trials.

FY2026 to FY2027 change Investment increases provides network support to enable improved coverage, protocols and decentralized data collection to enable medical readiness and response.

FY2027 planned work Transition and further develop organoid development and evaluation technologies to reduce the utilization of non-clinical models.

FY2026 to FY2027 change FY 2027 increase transitions organoid technologies from Science and Technology to reduce risks and reliance on traditional non-clinical models used for medical countermeasure development.

FY2027 planned work 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 development. Initiate manufacturing optimization efforts for additional medical countermeasure (MCM) modalities to accelerate and improve readiness against biological and chemical threats.

FY2026 to FY2027 change Increase due to support of FDA engagements and preparatory accelerations of 100-day manufacturing sprints to improve readiness against biological and chemical threats.

FY2026 plans — current year Complete subset of optimized manufacturing processes for multiple vendors.

FY2025 accomplishments Continued to develop innovative approaches that span the drug development lifecycle for optimization of the current manufacturing platforms/techniques for the seamless integration into an emergency response system. Initiated system tests for platform optimization to optimize two platform technologies

FY2027 planned work 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.

FY2026 to FY2027 change Decrease due to program shift from solely sourcing non-clinical testing articles to evaluating new alternative models to reduce CBDP enterprise risk and reliance on traditional non-clinical models for MCM development.

FY2026 plans — current year Continue contract to support the purchase of nonclinical models at staggered intervals.

FY2025 accomplishments Secured two sources of essential non-clinical testing articles for up to three performing entities in support of preclinical studies for CBDP enterprise. Executed quarterly requests for information to canvas and project future FY needs. Partnered with other government agencies to collaborate on resourcing CBDP non-clinical supply needs.

FY2027 planned work 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.

FY2026 to FY2027 change Increase due to an upscale of efforts to mitigate supply chain risks through on-shoring KSM and API materials for MCM development activities.

FY2026 plans — current year Complete FDA regulatory filings and continue storage of API for stockpile

FY2025 accomplishments Developed a synthetic Active Pharmaceutical Ingredient (API) manufacturing pathway for a key medical countermeasure (MCM) and on-shored key starting materials (KSM) for the MCM.

FY2027 planned work 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.

FY2026 to FY2027 change Increased investment enables medical readiness and response through integrated systems and innovative processes and technologies to identify potential process and technology barriers.