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. In FY 2023, the Chemical Biological Defense Program (CBDP) RDT&E Projects were restructured to align with the CBDP portfolio construct. MT5 efforts in FY 2022 remain in Projects DE5, MB5, and MC5. This restructuring provided standardization and alignment across CBDP research, development and acquisition efforts. Efforts included in this Project are: (1) Alternative Autoinjector Manufacturer Capability (AUTOINJ) (2) Antiviral Therapeutics Program (AV TX) (3) Countering Emerging Threats Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) (4) Countering Emerging Threats Rapid Acquisition and Investigation of Drugs for Repurposing-Enhanced Biodefense (CET RAIDR-ENBD) (5) Decontamination Family of Systems Contamination Indicator Decontamination Assurance System (DFoS CIDAS BLISTER) (6) Forward Area Mobility Spray - System (FAMS-S) (7) Improved Nerve Agent Treatment System Centrally Acting (INATS CA) (8) Service Equipment Decontamination System (SEDS) The AUTOINJ effort provides for FDA approved alternative source(s) for autoinjectors that deliver DoD nerve agent antidote and treatment capabilities to the warfighter; thereby mitigating capability fielding and operational readiness risks. This program augments legacy autoinjectors, antidote treatment nerve agent autoinjector (ATNAA), 2-PAM, and Convulsant Antidote for Nerve Agents (CANA) by providing alternative commercial sources which includes Dual Drug Delivery Device (D4), the Atropine Auto-Injector, and an anticonvulsant autoinjector. In FY24, AUTOINJ will submit New Drug Application packages to the FDA for D4 and Alternative-Diazepam, initiate activities for a wet-dry atropine autoinjector that provides an extended shelf-life compared to the fielded FDA approved Atropine Auto-Injector. The Anti-viral Therapeutics (AV TX) program will develop and deliver a Food and Drug Administration (FDA) approved antiviral therapeutics for the warfighter. Based on the current gap in defense to 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 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 leverage lessons learned to 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 Non-Human Primate (NHP) studies to repurpose as a CBRN Medical Countermeasure. Studies will generate safety and efficacy data to support the use of these tested product against CBRN threats. Efforts include additional investments in enhanced biodefense and pandemic preparedness. The Decontamination Family of Systems (DFoS) Contamination Indicator Decontamination Assurance System (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. In FY24, the program will conduct a Manufacturing Readiness Assessment (MRA) and a Physical Configuration Audit (PCA) with Prime Contractor and complete Operational Testing in support of Full Rate Production (FRP)/Fielding Decision. FY24 is last year of BA5 funding, program is transitioning to Production. 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. FAMS-S is a Middle Tier Acquisition (MTA) program. The 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 FY24, INATS CA will continue nonclinical work to refine the efficacious dose, complete functional and environmental testing for the autoinjector, and begin manufacture of current Good Manufacturing Practice (cGMP) registration lots. Interaction with the FDA under PL115-92 will occur during nonclinical testing and autoinjector development. The Joint Service Equipment Decontamination System (SEDS) and SOF Critical Equipment Decontamination (CEDS) programs 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 sustain the both the Joint and Special Operations Forces by reducing 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 that have been 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 FY24, the Joint SEDS effort will continue through the EMD phase with Developmental Testing (DT) and a Critical Design Review (CDR).

Document Details

• Document Type: Project
• Publication Date: Oct 01, 2024
• Source ID: MT5_0604384BP_5_0400_PB_2024

Tags

Readers

• Critical Infrastructure Protection in CBRN and WMD Threats.
• Neurotoxicology