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 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 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)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), and (8)Services Equipment Decontamination System (SEDS) The AUTOINJ program 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, 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 FY23, AUTOINJ will submit to the FDA an Emergency Use Authorization package for D4, 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, and initiate activities for an Alternative-Midazolam (anticonvulsant) autoinjector. The AV TX program will develop and deliver FDA approved antiviral therapeutics for the warfighter. Based on the current gap in defense to the warfighter, the initial therapeutic candidate is now for a treatment against the Marburg virus in lieu of Ebola Zaire to follow for approval of a PanFilo therapeutic. Other pathogens on the biological warfare threat lists, including viruses of interest from Filoviridae, Arenaviridae, Bunyaviridae, and Flaviviridae, are targets of future interest. Developed broad spectrum antiviral therapeutics will be employed after suspected or confirmed exposure to the relevant threat agents and AVTX Medical Countermeasures (MCMs) 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. FY23 funding is required for completion of efficacy studies and to prepare Food and Drug Administration (FDA) approval package. The CET RAIDR program will develop repurposed drugs as medical countermeasures towards known, potential, and unknown and emerging threats, bridging the gap from when a threat is identified until targeted countermeasures such as vaccines are available. CET RAIDR will leverage lessons learned in Coronavirus Aid, Relief, and Economic Security (CARES) Act funded efforts under Coronavirus Disease (COVID) Repurposed Therapeutics (CR TX) and address advanced development portion of Science and Technology (S&T) efforts from Development of Medical Countermeasures Against Novel Entities (DOMANE) program for new and emerging threats. FY23 CET RAIDR funding is required to ensure development of up to two FDA-approved or late-stage products for repurposing against chemical and biological medical indications. The FY23 CET RAIDR-ENBD funding enables the development of at least two FDA-approved or late stage products for repurposing against chemical and biological medical indications. The 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. In FY23, Program will award contract option with prime contractor to acquire 200 SSA Blister Kits and 45 LSA Blister Kits to complete DT, conduct System Verification Review (SVR), Production Readiness Review (PRR), Functional Configuration Audit (FCA) and Logistics Demonstration, as well as award Low-Rate Initial Production (LRIP) option for production representative kits for 25 SSA-B kits and 30 LSKB kits in support of Operational Test planned for 4QFY23. 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. The FAMS-S will be developed using a Middle Tier Acquisition (MTA) approach. In FY23, FAMS-S completes prototype refinement and the developmental and operational testing phase. 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. INATS CA includes modernization of Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP; pyridostigmine bromide [PB] tablets). In FY23, INATS CA will complete nonclinical work to refine the efficacious dose, complete functional and environmental testing for the autoinjector, and begin manufacture of cGMP registration lots. Interaction with the FDA under PL115-92 will occur during nonclinical testing and autoinjector development. The SEDS program 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 Joint Force military by reducing logistical burden to increase tactical agility and sustain a resilient force posture, and align with the National Defense Strategy. SEDS 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 FY23, the Program will conduct MS B activities for Special Operation Forces (SOF) and Other Services, award contract to conduct EMD testing, conduct Preliminary Design Review (PDR) for SOF and prepare for Operational Assessment for SOF and EDT for Other Services.

Document Details

• Document Type: Project
• Publication Date: Oct 01, 2023
• Source ID: MT5_0604384BP_5_0400_PB_2023

Tags

Readers

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

Technology Areas

• Biotechnology