Chemical and Biological Defense Program - Dem/Val

The BCIS-ENBD program will provide a negative pressure shelter system for medical treatment of biologically contaminated patients in a field hospital environment. BCIS-ENBD benefits the warfighter by providing a ground-based isolation area for personnel infected or suspected of infection from a biological threat and allows medical staff to monitor and/or treat while decreasing the risk of infecting other patients and staff. This project was funded in FY 2024 under the Collective Protection CONEX-Enhanced Biological Defense (COL PRO CONEX-ENBD) effort and beginning in FY 2025 was renamed BCIS-ENBD to accurately reflect the capability and applicability of the system.

The ADD will provide the capability to perform presumptive disease classification and differentiation of unknown biological threats, during early stages of illness, suitable for use at the lowest Roles of Care. These unknown threats may include traditional/non-traditional biological warfare agents, as well as other known/unknown and emerging infectious diseases. ADD benefits the warfighter by providing timely feedback for disease prevention in operational environments, quickly identifying warfighters who may have contracted illness. ADD is a new start program in FY 2024.

The AET Defense program continues to address the highest priority chemical and biological (CB) gaps and supports the Chemical Biological Defense Program (CBDP) Strategic Line of Effort to meet current and emerging threats by anticipating chemical, biological and toxin hazards and identifying capabilities to counter emerging and future threats. The AET Defense program collaborates with the Joint Services and interagency to align RDT&E resources to determine readiness against emerging threats as they are identified across the entire CBDP enterprise portfolio.

The CIND is a low-cost, easy to use, ultra-low size, weight, power and cost (SWaP C) modular open system based chemical detector that is widely distributed to the General Forces as an integrated kit for indication of chemical hazards. CIND will provide detection and classification capabilities for traditional, advanced and or emerging chemical hazards such as chemical warfare agents (CWA), non-traditional agents (NTA), pharmaceutical-based agents (PBA), riot control agents (RCA), toxic industrial chemicals (TIC) and toxins in all states of matter (solid, liquid, vapor, aerosol). CIND benefits the warfighter by providing a low-cost, easy to use, higher confidence liquid, solid and vapor hazard detection capabilities for traditional, non-traditional, pharmaceutical-based, emerging chemical and toxin hazards. CIND is a new start program in FY 2025.

Chemical and biological (CB) Support to CSC2 is the overarching System of Systems that provides Service and Combined Joint All Domain Command and Control (CJADC2)-compatible CB Common Operating Environment (COE) architecture and deployment environments for the interoperability and integration of CB and non-CB sensor data to achieve needed situational awareness and understanding, interdependent with Service and Mission Partner COE and Computing Environments.

FFBS system is a rapid handheld biological sequencing device that will identify an unlimited number of Biological Warfare Agents (BWAs) to include emerging or engineered biological weapon threats on or near the objective. It will provide far-forward Special Operations Forces (SOF) and Special Operations Task Forces (SOTFs) the detect-to-inform capability with near-real time identification of BWAs. FFBS will significantly increase the situational awareness of biological threats to SOF forces operating in a far forward environment and decrease the tactical decision timeline from weeks to hours. FFBS will increase tactical flexibility and fighting strength, protect the Special Operations Forces, and it will save lives.

The Non-Targeted Sequencing Identification System (NSIS) provides a rapid biological sequencing capability to identify known, emerging, engineered, or enhanced biological warfare agents (BWA). NSIS allows for the detection of genetically-engineered agents at the point of attack, reducing potential spread and increasing opportunity for containment. NSIS capability will increase the Joint Force's ability to identify agents beyond those currently targeted by fielded equipment, providing early warning of a potential outbreak or attack and informing decisions to protect the Homeland and Joint Force Missions. NSIS benefits the warfighter by enabling untargeted analysis on-site to provide actionable intelligence to the Commander at the speed of relevance.

The PCAD provides handheld identification of visible liquid and solid chemical threats observed by the warfighter at standoff (non-contact) distances. PCAD is intended to enhance mission effectiveness by reducing sample analysis time in the field. PCAD benefits the warfighter by providing a handheld stand-off (non-contact) capability to identify chemical hazards, providing commanders with decision quality to inform follow-on decisions.

The PM2S program transitions efforts to the Chemical and Biological Wearables (CB WEARABLES) program line in FY 2026. The PM2S program develops chemical and biological (CB) exposure software capabilities that analyze physiological data collected from wearable sensors. These capabilities provide commanders with actionable information to maximize warfighter readiness, performance, and enhance resiliency before, during, and after CB operations.

The CB WEARABLES program integrates software capabilities transitioned from the Physiological Monitoring Sensor Suite (PM2S) program line with wearables equipping initiatives. The program develops and equips joint warfighters with software capabilities that analyze physiological data collected from wearable sensors and alert potential exposure to chemical and biological (CB) threats. These software capabilities, which integrate into the hardware-focused decision support tools developed under the CB WEARABLES - Enhanced Biological Defense (ENBD) program, provide commanders with actionable information to maximize warfighter readiness, performance, and resiliency before, during, and after CB operations.

The SPCHAR-ENBD utilizes Pathogenicity Studies to investigate development of chemical and biological defense threat agents and verify usefulness of models. SPCHAR-ENBD benefits the warfighter by identifying targets from study results for MCM (Medical Countermeasures) development, testing, and helps to identify groups of chemical and biological defense threat agents susceptible to broad-spectrum MCMs.

The Compact Vapor Chemical Agent Detector (CVCAD) is a light weight chemical detection capability that will continuously, and autonomously, monitor and alert joint forces to an unsafe environment without further burdening the warfighters payload or interfering with the primary mission. CVCAD will warn of Chemical Weapon Agents (CWA), Toxic Industrial Chemicals (TIC), and confined space hazards to inform immediate force protection decisions. The small form factor (less than two pounds) is amenable to both man-worn and unmanned aerial or ground system operations to enable timely personnel protective action and other force protection decisions. CVCAD benefits the warfighter by providing a person worn chemical vapor detector that warns the wearer to the presence of a variety of chemical vapor hazards.

The ASPIRE Next Generation Respirator (NGR) effort provides respiratory and ocular protection against Chemical and Biological (CB) threats that allows near normal operations in a CB environment. The program will lay out the strategy and path forward required to minimize the burden to the warfighter while still providing respiratory and ocular protection against CB agents. ASPIRE benefits the warfighter by providing respiratory and ocular protection minimizing or eliminating physical and psychological burden and increasing warfighter lethality.

The AA-ENBD will develop prophylactic and therapeutic monoclonal antibody (mAb) Medical Countermeasures (MCMs) against a broad range of biological threats. AA-ENBD will build prototype MCMs at a sufficient technical and regulatory maturity (e.g., non-clinical and clinical) with quantities of associated doses ready for potential emergency use against biological threats. AA-ENBD benefits the warfighter by providing operational data packages and/or sufficient doses that will be produced and maintained for either further development (through full licensure) and/or can be incrementally fieldable for potential use in emergency response situations.

The COL PRO CONEX-ENBD effort will provide a negative pressure shelter system for medical treatment of biologically contaminated patients in an Army field hospital environment. COLPRO CONEX-ENBD benefits the warfighter by providing a ground-based isolation area for personnel infected or suspected of infection from a biological threat and allows medical staff to monitor and/or treat while decreasing the risk of infecting other patients and staff. COL PRO CONEX-ENBD was renamed Biological Containment Isolation System - Enhanced Biological Defense (BCIS-ENBD) beginning in FY 2025 to accurately reflect the capability and applicability of the system. COL PRO CONEX-ENBD was a new start program in FY 2024.

The GUIDE-ENBD is an intelligent drug design and engineering system intended to decrease product development risk throughout the medical countermeasure development life cycle, accelerate candidate development, and enable preemptive preparedness and rapid response. GUIDE-ENBD is a collaboration between interagency, academia, and industry partners. GUIDE-ENBD benefits the warfighter by fundamentally changing our biodefense response posture by taking a strategic approach to threat space, mitigating product development risks to allow for evolutionary acceleration, and creating a capabilities-based framework and infrastructure to enable response.

The MCMPT program streamlines and accelerates medical countermeasure delivery to the Warfighter by establishing, maturing, and/or transitioning enabling technologies from the Science and Technology base. These technologies can reduce time for product development and eventual emergency fielding. MCMPT benefits the warfighter by leveraging S&T investments focused on platform systems and then prepositioning them within the Department of Defense (DoD)'s Advanced Development Manufacturing (ADM) network.

Host Directed Countermeasure

The PLG MAB program will provide a pre-exposure monoclonal antibody based medical countermeasure for protection against aerosolized Yersinia pestis (plague) exposure. PLG MAB product will have sufficient technical and regulatory data (e.g., non-clinical and clinical) and associated doses which can be further developed (through full licensure) and/or can be incrementally fielded for potential use in emergency response situations. PLG MAB benefits the warfighter by providing a pre-exposure product which contributes to the integrated layered defense against this high priority pathogen.

The VAMP-ENBD leverages lessons learned to shorten future emergency response timelines, mitigate impacts of biological threat outbreaks, and create interim capabilities to protect the warfighter. Leveraging interagency, industry, and academia partnerships, VAMP-ENBD continues to build the warfighter's bio-armor to protect against biological threat families. VAMP-ENBD benefits the warfighter by expediting prototype vaccine medical countermeasure delivery by advancing and accelerating development of existing vaccine platforms. VAMP-ENBD has transferred two vaccines to Rapid Access to Products In Development (RAPID) and is advancing nine vaccine candidates utilizing platform technologies.

The PPTS-ENBD will provide a biocontainment isolation system to safely transport personnel infected or suspected of infection. The project will evaluate and/or improve upon previous biocontainment isolation transport systems (for example, Transport Isolation System, Chemical-Biological Aircraft Survivability Barrier, Portable Bio-containment Care Module, Negatively Pressurized Conex, and Casualty Containment Litter). PPTS-ENBD benefits the warfighter by providing a means to safely transport asymptomatic, infected, or symptomatic patients with known or suspected exposure to contagious and infectious diseases while protecting transport vehicles and support personnel. PPTS-ENBD was a new start program in FY 2024.

The SIS project will provide the capability to temporarily isolate or quarantine personnel to prevent the spread of a biological threat. SIS will be used on multiple Navy ship classes. SIS benefits the warfighter by containing and medically monitoring/treating patients while protecting embarked crew and personnel. SIS was a new start program in FY 2024.

The ADS provides a semi-autonomous supported capability that relies on precision detection capabilities, modernized decontaminants, and robotics to allow a Chemical and Biological (CB) decontamination squad to provide platoon level thorough decontamination on critical mission equipment. ADS benefits the warfighter by mitigating the risk of exposure of warfighters to chemical agents by accomplishing mitigation tasks through robotic means. ADS was a FY 2024 New Start program.

AD TX is a new start in FY 2025. The program is a capability that will go after multiple virus families to develop and deliver Food and Drug Administration (FDA) approved broad-spectrum antiviral therapeutic Medical Countermeasures (MCM) against highly contagious and lethal threats to the warfighter. Developed agent directed broad spectrum AD TX will be employed after suspected or confirmed exposure to known or potential threat agents, providing a rapid treatment response. AD TX will benefit the warfighter by providing broad-spectrum treatment solutions for viral infections with the Arenaviruses and Paramyxoviruses threat preserving combat power.

AVO TX will provide the Joint Force the ability to recover from exposure to biological hazards. Efforts include development of Food and Drug Administration (FDA) approved Medical Countermeasures (MCM) oral broad spectrum therapeutic against disease caused by Equine Encephalitic Alphaviruses. Antiviral Oral Therapeutics program will benefit the warfighter by providing broad-spectrum treatment solutions for viral infections with the Alphaviruses threat preserving combat power. AVO TX program was a new start in FY 2024.

BOT TX is the development a U.S. Food and Drug Administration (FDA) approved treatment to treat respiratory depression caused by botulinum intoxication. This intravenous injectable treatment will be developed by reformulating an oral drug product already approved by the FDA. Botulinum Toxin Therapeutic program will benefit the warfighter by providing treatment for intoxication with Botulinum Toxin A. BOT TX provides protection to the warfighter from respiratory depression caused by botulinum intoxication preserving combat power. The BOT TX program was a new start in FY 2024.

The CNATS will deliver an FDA-approved autoinjector that combines anticholinergics, atropine and scopolamine, and a new, improved oxime. CNATS benefits the warfighter by combining nerve agent treatments into fewer autoinjectors, reducing the basic load for service members, and increasing survivability. CNATS is a new start program in FY 2025.

The MED DECON PS will provide a personnel decontamination capability to lessen the effects of chemical warfare nerve agents on intact skin, eyes, and contaminated wounds. MED DECON PS will benefit the warfighter by providing a broad-spectrum chemical skin decontamination capability with low logistics footprint (e.g., shelf life and storage conditions). MED DECON PS is a new start program in FY 2025 for intact skin and wound decontamination capabilities.

The RNATS will provide an FDA-approved improved oxime in a vial formulation to address emerging chemical threats and fourth generation agents (FGAs). RNATS will benefit the warfighter by increasing survivability against a broad spectrum of chemical warfare nerve agents, mitigating risks from nerve agent exposure, and reducing the impact of nerve agent intoxication. RNATS was a new start program in FY 2024.

The TCMS will provide a forward deployed contamination mitigation capability (decontaminant and applicator) that allows expeditious execution of decontamination that results in Mission Oriented Protective Posture reduction/removal. TCMS will decontaminate hardened equipment, such as vehicles, weapons and other critical assets. TCMS benefits the warfighter by mitigating risk to personnel by limiting the potential spread of Chemical and Biological (CB) contamination allowing warfighters to continue their mission for an extended period in a high threat, CB contaminated environment and eliminate the need for subsequent decontamination to mitigate contamination on military equipment and allow continuation of mission at a high tempo.

The CBIPR-MODEL effort supports Science and Technology and Advanced Development studies under the Chemical and Biological Defense Program (CBDP). CBIPR-MODEL will source and purchase, in advance, essential nonclinical models that are both fit-for-purpose and required for Food and Drug Administration (FDA) approval of medical countermeasures (MCMs). CBIPR-MODEL benefits the Warfighter by securing these nonclinical models that are critical in demonstrating the safety and efficacy of new MCMs to combat current and emerging chemical and biological (CB) threats.

The MCM MFRO enhances the existing DoD manufacturing capabilities and enables a priority access mechanism with industry partners to enable rapid response to biological incidents. MCM MFRO leverages partners across Industrial Base, Chemical and Biological Defense Program, and Defense Health Program to reduce time required to onshore materials critical to the rapid production of medical countermeasures (MCMs). In addition, MCM MFRO optimizes existing manufacturing platforms for MCM development efforts to decrease the time to an interim fielding capability. MCM MFRO benefits the warfighter by accelerating the manufacturing timelines associated with MCM prototypes and by onshoring critical materials needed for those products.

Small Molecule Synthesis

The CBIPR-ADM ensures prioritization to domestic biopharmaceutical manufacturing capacities, capabilities, and infrastructure (e.g. the DoD-ADM Facility and other strategic partners) that are operationally ready to rapidly develop and manufacture medical countermeasures (MCMs) against current and emerging chemical and biological threats including pandemic response. Prioritization is achieved by establishing and enhancing proven biopharmaceutical manufacturing platform technologies and infrastructure at these facilities. MCMs that benefit from these efforts include Vaccines for Viral Agents, Vaccines for Bacterial Agents and Toxins, monoclonal antibodies, antibody fragments and conjugates for therapeutic and prophylactic use across all agent classes. CBIPR-ADM benefits the warfighter by providing the capability to accelerate development of MCMs at all stages of development, enhance preparedness for existing threats, and rapidly respond to emerging threats as part of a medical integrated layered defense.