Mitigate (SDD)
Abstract
The Mitigate System Development & Demonstration (SDD) Project provides the Joint Force the ability to recover from exposure to chemical and biological hazards and quickly return to the fight. Efforts include development of U.S. Food & Drug Administration (FDA) approved medical countermeasures (MCMs) to protect the lives and maintain the battle readiness of the warfighter. Efforts also provide safe, effective MCMs to enable warfighter recovery and return to duty after exposure to chemical threat agents, and reduce logistics needs of decontamination methods with operationally-relevant test methods and allows personnel to reduce Mission-Oriented Protective Posture (MOPP) levels as rapidly as possible. Activities in this project realize considerable efficiencies through cost sharing agreements. Efforts included in this Project are: (1) Alternative Autoinjector Manufacturer Capability (AUTOINJ) (2) Countering Emerging Threats Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) (3) Countering Emerging Threats Rapid Acquisition and Investigation of Drugs for Repurposing-Enhanced Biological Defense (CET RAIDR-ENBD) (4) Improved Nerve Agent Treatment Centrally Acting (INATS CA) (5) Service Equipment Decontamination System (SEDS) (6) Tactical Contamination Mitigation System (TCMS) (7) Decontamination Family of Systems Contamination Indicator Decontamination Assurance Spray Blister (DFoS CIDAS BLISTER) (8) Antiviral Therapeutics (AV TX) (9) Forward Area Mobility Spray System (FAMS-S) The Alternative Autoinjector Manufacturer Capability (AUTOINJ) program expands the industrial base to provide Food and Drug Administration (FDA)-approved alternative source(s) for currently-fielded autoinjectors that deliver Department of Defense (DOD) Nerve Agent (NA) antidote and treatment capabilities to the warfighter. This industrial base expansion reduces the inventory risk of a single source and mitigates capability fielding and operational readiness risks. This program augments legacy autoinjectors - Antidote Treatment Nerve Agent Autoinjector (ATNAA) and AtroPen, by providing alternative commercial sources, which includes the Dual Drug Delivery Device (D4), the Atropine Autoinjector, and Reconstitution Autoinjector Device - Atropine (RAD-A), previously referred to as Wet-Dry Autoinjector. In FY25, the program will be initiating the development of the semi-automated manufacturing line for RAD-A. The Countering Emerging Threats Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) program will develop repurposed drugs as medical countermeasures towards known, potential, and emerging threats, bridging the gap from when a threat is identified until targeted countermeasures are available. CET RAIDR will repurpose U.S. Food & Drug Administration (FDA) approved therapeutics to reduce risk to the warfighter by providing medical countermeasures to CBRN threat symptoms. CET RAIDR will evaluate FDA-approved and/or late-stage products through nonclinical studies to repurpose as a CBRN Medical Countermeasure. Studies will generate safety and efficacy data to support the use of these tested products against CBRN threats. In FY25, the CET RAIDR program will generate data to inform the Clinical Practice Guidelines. The Countering Emerging Threats Rapid Acquisition and Investigation of Drugs for Repurposing - Enhanced Biological Defense (CET RAIDR-ENBD) program will use nonclinical safety/efficacy model studies to evaluate FDA-approved and/or late stage products to repurpose as a CBRN Medical Countermeasures toward known, potential, and emerging threats, bridging the gap from when a threat is identified until targeted countermeasures are available. Studies will generate safety and efficacy data to support the use of these tested product against CBRN threats. In FY25, the CET RAIDR-ENBD program will generate safety/efficacy model data to inform the Clinical Practice Guidelines. The Improved Nerve Agent Treatment System Centrally Acting (INATS CA) program will develop the centrally-acting anticholinergic, scopolamine, to increase survivability and decrease morbidity following exposure to toxic nerve agents. When added to currently fielded nerve agent treatments, scopolamine will improve overall medical outcomes and will be available in both a vial for use at definitive care, and in an autoinjector for use in the field. In FY25, INATS CA will complete all non-clinical studies required to support the scopolamine vial new drug application (NDA) submission, continue scopolamine vial stability studies, submit NDA for scopolamine vial, continue functional and environmental testing for the autoinjector device, and begin manufacturing of current Good Manufacturing Practice (cGMP) autoinjector registration lots. Interaction with the FDA through Public Law 115-92 prioritization will continue throughout non-clinical testing, scopolamine vial NDA review and autoinjector development. The Service Equipment Decontamination System (SEDS) program consists of two efforts, Joint SEDS and Special Operations Forces (SOF) Critical Equipment Decontamination (CEDS), which will develop reliable and modular hardware intended to decontaminate military equipment in operational environments, including personal effects and weapons, to pre-contamination conditions. This capability is needed to reduce logistical burdens in order to increase tactical agility and sustain a resilient force posture and align with the National Defense Strategy (NDS). SEDS and CEDS will provide contamination mitigation capabilities for critical equipment exposed to chemical and biological contamination and achieve efficacy levels that allow unprotected post-decontamination exposures for long periods with less than negligible severity effects. In FY25, Joint Service SEDS Engineering & Manufacturing Development (EMD) Phase continues with Developmental Testing, Operational Testing (DT/OT), and Operational Assessment (OA). In FY25, the CEDS (SOF) will complete DT/OT testing and program documentation in preparation for entry into the Production and Deployment (P&D) phase. The Tactical Contamination Mitigation System (TCMS) will address gaps related to the decontamination of critical equipment and vehicles and reduce the time and logistics associated with decontamination. TCMS will limit the spread and mitigate the effects of Chemical, Biological, and Radiological (CBR) contamination to allow warfighters to continue their mission for an extended period of time in a high threat, CBR contaminated environment. The effort will mitigate risk to personnel by limiting the potential spread of CBR contamination and eliminate the need for subsequent decontamination to mitigate contamination on military equipment. TCMS, when combined with weathering, may reduce Mission Oriented Protective Posture (MOPP) level requirements. FY25 BA5 funding will achieve Milestone B, conduct critical design review (CDR) and a test readiness review to support the initiation of Development Testing/Operational Testing (DT/OT). The Decontamination Family of Systems Contamination Indicator Decontamination Assurance Spray Blister (DFoS CIDAS BLISTER) program addresses traditional blister agents, two separate threat scenarios that require different materiel solutions, modernizing a key capability to help build a more lethal force, as outlined in the National Defense Strategy. Program efforts terminate in FY24 and all CIDAS Blister programmatic documentation will be archived and the Joint Requirements Office will enter the Capability Development Document (for the CIDAS Blister KSA) in the Knowledge Management/Decision Support tool for Archiving. The Anti-viral Therapeutics (AV TX) program will develop and deliver a Food and Drug Administration (FDA) approved antiviral therapeutics for the warfighter. The initial therapeutic candidate is a treatment against the Marburg virus. Developed broad spectrum antiviral therapeutics will be employed after suspected or confirmed exposure to the relevant threat agents and AV TX Medical Countermeasures (MCM) will ameliorate the effect of threat agents to the warfighter. In the event of a natural occurring outbreak, antiviral therapeutics can be provided to ensure freedom of operation. The FAMS-S will provide Special Operations Forces (SOF) and SOF Task Forces (SOTFs) with transportable, rapidly-deployable decontamination systems in three variants: man-portable, small vehicle-mounted, and large vehicle-mounted systems to rapidly decontaminate chemical and biological (CB) agents from the exterior of vehicles and support equipment to a level that is clean enough for re-use during missions without the need for donning CB personal protective equipment. This will maximize tactical flexibility and fighting strength while minimizing the logistical burden and the cost of conducting Countering Weapons of Mass Destruction (CWMD) and CB operations. BA5/RDTE activities closed out in FY23.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2025
- Source ID
- MT5_0604384BP_5_0400_PB_2025
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- Root: Chemical and Biological Defense Program - EMD
- Child Accomplishment: 1) AUTOINJ - RAD-A
- Child Accomplishment: 2) AUTOINJ - Dual Drug Delivery Device (D4)
- Child Accomplishment: 3) CET RAIDR
- Child Accomplishment: 4) CET RAIDR-ENBD
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- Child Accomplishment: 7) INATS CA - Non-Clinical
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- Child Accomplishment: 9) TCMS
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- Child Accomplishment: 11) AV TX
- Child Accomplishment: 12) FAMS-S
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