Chemical and Biological Defense Program - Advanced Development

Provides innovative and rapid medical countermeasures (MCMs) development capabilities (Artificial Intelligence, machine learning, data science, and platform technologies) that reduce developmental risks, cost, and schedule associated with MCM fielding. Building upon previous investments in Discovery of Medical Countermeasures Against Novel Entities (DOMANE) (e.g. BA2 funded efforts), this program focuses on predictive and generative AI/ML capabilities to rapidly identify safe and effective MCMs against a broad range of new and emerging threats.

This effort focuses on rapid medical countermeasure (MCM) system development of tools and platforms to enable disease predictions, identify druggable targets and recommend possible MCMs.

While there exist multiple processes and reagents for cleaning physical surfaces that have been contaminated with chemical agents, there are limited options for human skin, and nothing that could be used for open wounds. This represents a source of continuing exposure for the warfighter and a hazard to medical personnel treating them. CROWD focuses on developing a ready-to-use product to remove Chemical Warfare Agent (CWA) contamination on skin, eyes and ultimately wounds. Removing or neutralizing CWA decreases the total exposure to the warfighter and allows optimal effectiveness of other medicines.

This portfolio is focused on developing chemical medical countermeasures (cMCMs) that prevent or treat the adverse effects of priority emerging chemical threats as well as identifying threat agnostic cMCMs that can treat multiple symptoms.

The ReACT portfolio is developing a number of different candidate medicines that are effective against a broader range of nerve agents – including fourth generation agents - than had ever before been thought possible. Successful development of these medicines will greatly enhance the ability of the warfighter to survive, recover, and continue with assigned duties.

Critical Area Decontamination mitigates hazards and contamination spread in mission-critical areas, such as airports and seaports, that are operationally essential for Combatant Command (CCMD) commanders to generate combat power within the theater of operations and enable normal, unprotected operations. This will enhance the Joint Force’s ability to fight through and recover rapidly from adversary CB attacks on these mission-critical areas.

Advanced Technology Demonstrations (ATDs) are Joint Task Force (JTF) scenario-based experiments that demonstrate and evaluate groupings of integrated technologies or prototype systems, prioritized on warfighter operational needs in the context of the future fight, mitigate transition risk by assessing technologies for Doctrine, Organization, Training, Materiel, Leadership and Education, Personnel, Facilities and Policy (DOTMLPF-P) considerations and demonstrating operational utility.

Enhanced Survivability Coatings assesses existing technologies and develops new coatings to increase chemical agent resistance for equipment. This will make it quicker and easier to decontaminate and restore assets for use in normal, unprotected operations. It will also allow the Joint Force to reduce individual protective gear more quickly.

Equipment Decontamination develops decontaminant systems, formulations, and procedures that reduce or eliminate residual contamination hazards; enable decentralized unit-level decontamination with rapid unmasking; reduce manpower and logistics (e.g., water) needed to accomplish the task; enable rapid sorting of clean from dirty to rapidly return high-value equipment to normal, unprotected use; develop improved realistic test methods.

Multifunctional Materials for Protection (MMfP) matures next generation hazard mitigation materials for decontaminants and equipment coatings that absorb, neutralize, and repel chemical and biological warfare agents, which will reduce costs by extending service life and make decontamination easier. MMfP begins manufacturing and scaling processes for technologies that transition to all physical hazard mitigation thrust areas.

Personnel Decontamination provides new personnel decontamination kits with reduced costs and logistics (storage and shelf-life limitations) compared to the currently fielded product and provides new processes and methods for decontamination of unbroken skin.

Wide Area Decontamination develops autonomous systems and formulations for decontamination of mission-critical terrain.

Equipment Decontamination - Enhanced Biological Defense provides guidelines, standards, and methods for disinfection of Department of Defense (DoD) facility and large-platform interiors; provides biological contamination mapping capability for surfaces.

Wide Area Decontamination develops autonomous systems and formulations for biological decontamination of mission-critical terrain.

Critical Area Decontamination - Enhanced Biological Defense uses autonomous systems to mitigate biological hazards and contamination spread in mission-critical areas, such as airports and seaports. These areas are operationally essential for Combatant Command (CCMD) commanders to generate combat power within the theater of operations and enable normal, unprotected operations. Autonomous decontamination will reduce manpower, resources, and risk to the Joint Force, enabling them to fight through and recover rapidly from adversary CB attacks on these mission-critical areas.

This effort will focus on the development and validation of alternate safety/efficacy models that mimic the human system. Investment includes efforts to advance multiple models to replace, reduce, or refine appropriate models for demonstration of safety and efficacy use in medical countermeasure development in alignment with Congressional requirements (the Food and Drug Administration (FDA) Modernization Act 2.0).

This thrust area invests in breakthrough technology to improve wearable device-based early warning capabilities by conducting data collection trials to support algorithm development; leveraging artificial intelligence (AI) to identify key indicators of exposure, combinations of indicators, and sensing modalities; and exploring alternative methods for non-invasive early warning of chemical and biological (CB) exposure. This will reduce false alarms and strengthen predictions of potential CB exposure—including emerging threats. This thrust area will enable the ability to achieve CB information dominance and make hard decisions easier.

Understanding how various chemical and biological (CB) threats—both traditional and emerging—interact with the environment and impact the human body is essential to support CB information dominance and enables the joint force to operate effectively in a CB-contested environment. Leveraging data from other science and technology (S&T) programs, CB Defense Situational Awareness creates forecasting models and hazard assessments to provide warfighters with optimal situational awareness in these environments. This thrust area is also exploiting advances in eXtended Reality (XR), Virtual Reality (VR) and Augmented Reality (AR) to provide warfighters with an immersive environment for realistic training and mission rehearsal opportunities.

The Chemical Biological Defense Program (CBDP) is enhancing the warfighters’ ability to seek medical treatment earlier and take other measures to minimize the impact to joint force operations, by identifying exposure to biothreats at the earliest time possible, including before symptoms appear. This will enable the CBDP to achieve chemical and biological (CB) information dominance and make hard decisions easier at all echelons of operations. Efforts in this area include focusing on data collection and analysis of CB exposure data; competitive prototyping of wearable-based early warning algorithms to optimize performance; expansion of efforts to develop analytic resources for early warning/decision support; and the advancement of an integrated cloud-based data environment to store a dynamic knowledge base of biothreat characteristics.

Develop and deliver improved solutions for comprehensive biothreat characterization in support of achieving chemical and biological (CB) information dominance and Chemical and Biological Defense Program (CBDP) biodefense modernization goals, to include leveraging a cloud based data environment of biothreat characteristics, data sources, repositories created and curated under the Chemical, Biological, Radiological and Nuclear (CBRN) Battlespace Sensing, Alerting, and Response thrust area, and translating it into actionable information for transmission to and use on end-user devices (EUDs).

Explore solutions for comprehensive biothreat characterization to achieve chemical and biological (CB) information dominance and support of Chemical and Biological Defense Program (CBDP) biodefense modernization goals, including the development of data analytics using machine learning (ML) and artificial intelligence (AI) and efforts to provide a suite of analytic tools for biological threat agent modeling, forecasting, and prediction to determine optimal defense postures.

Provide innovative and integrated capabilities to the warfighter that are able to diagnose threats across the chemical spectrum. Enhance force protection by investing in diagnostics for exposure to traditional and nontraditional Chemical Warfare Agents (CWA), including pharmaceutical based agents.

Develop diagnostic platforms that equip the warfighter with tools ensuring force protection against chemical and biological (CB) threats. Enhance force protection by investing in field forward, point of care medical diagnostics to identify multiple pathogens simultaneously.

Optimize the diagnostic development pathway by incorporating independent testing and evaluation for more informed prototype transition prior to advanced development. Investments in this area allow evaluation of diagnostic platforms through real world, austere environment testing. This area maintains access to research sites where populations are exposed to diseases of interest that would affect the warfighter in battlefield settings, thus providing valuable test data which will aid further prototype development.

Lays a foundation for the entire diagnostics portfolio by exploiting areas such as machine learning (ML), synthetic biology and chemistry to develop novel and rapid diagnostic tests for utilization in the event of an outbreak of an unknown threat.

Provide innovative capabilities to the warfighter that increase the speed of relevancy, enhance troop preparedness, aid with triage support, and provide diagnosis at lower roles of care. Develop field forward medical diagnostics that allow for multiplexed detection of biological and toxin threats. Leverage immunodiagnostics to identify specific targets using current or novel approaches to enable broader and more accurate diagnosis for a range of targets and across a wider window following exposure.

User Assessments are designed to optimize individual technologies for the intended mission, explore how Science & Technology (S&T) prototypes and models might support future capability gaps and high priority mission deficiencies and identify candidates for rapid acquisition initiatives. These projects work directly with the warfighter to help answer the question “What is the benefit to the mission?”

Advance the diagnosis of emerging and/or low prevalence but high threat biological agents leveraging novel technologies. Develop threat agnostic tests based on host biomarkers that identify known or emerging bacterial or viral infections. Characterize markers for antibiotic resistance or susceptibility to identify challenging threats and inform treatment decisions. Improve capabilities to identify diverse biological agents that are not well characterized using molecular or immunodiagnostic approaches.

Integrate advances in regulatory science, formulation and delivery technologies and processes. Also will develop safety/efficacy models, drug discovery and evaluation of platforms as enablers of the advanced development of Chemical Biological Defense Program medical countermeasure products. These initiatives will lead to the establishment of multi-use platforms, novel formulations and safety/efficacy models that can be leveraged during a chemical and biological (CB) response to accelerate medical product development and/or regulatory approval as well as reduce overall development costs.

Develop new science and technology capabilities that allow for the rapid characterization of emerging threats to support operational decision making and requirements setting. Support an integrated approach to developing new or enhanced countermeasures against emerging threats through innovative science and technology solutions for detection, protection, decontamination, and medical countermeasures (MCMs). Efforts supply test methodologies and supporting science to verify capabilities, develop protection and hazard mitigation options, expand hazard assessment tools, and develop MCMs against emerging threats. Chemical and Biological Emerging Threat Innovation Fund challenge DoD Labs and innovation cells to deliver transformational technologies against emerging threats that enables the force to compete, deter, and win in strategic environments.

This effort focuses on repurposing Food and Drug Administration (FDA) approved therapeutics to support the development of drug repurposing tools and processes to accelerate development of therapies that mitigate symptoms of disease and speed up delivery of therapeutic interventions.

Develop novel, state of the art capabilities that lay the foundation for modernizing other areas within the diagnostics portfolio. This includes exploiting areas such as synthetic biology and chemistry to develop novel and rapid diagnostic tests for utilization in the event of an outbreak of an unknown threat. Invest in efforts that lead to accelerated assay development timelines and optimized test parameters through leveraging artificial intelligence (AI) and machine learning (ML) to allow us to quickly pivot and develop assays for emerging threats in days instead of weeks.

Push beyond the boundaries of the traditional threat list in the field of diagnostics to better prepare for surprise. Development of diagnostic systems that leverage novel approaches to characterize pathogen or host response and can identify the classification of threat (e.g., bacterial vs viral) from an unknown sample. Invest in diagnostic tests that enable the delivery of actionable information, such as administering the appropriate medical countermeasure (e.g. antibiotic, antiviral, vaccine),at the lowest roles of care, greatly improves turnaround time for soldier wellness and return to duty.

Develop platforms to prepare the warfighter with rapid and easy to use diagnostics tests to make sure they are healthy and ready for movement. Platforms developed with affinity-based identification of either pathogen or host response to the pathogen may leverage immunodiagnostics to identify specific targets using antibodies, or explore other innovative approaches. This will enable broader and more accurate diagnosis for a range of targets and across a wider window following exposure. Investments in this area will provide capabilities to the warfighter that increase the speed of relevancy, enhance troop preparedness, aid with triage support, and provide diagnosis at lower roles of care.

In order to achieve chemical and biological (CB) information dominance and unencumber the warfighter at the tactical edge, efforts continue to develop and transition science & technology (S&T) for CB defense Decision Aids on end user devices (EUDs) in both connected and disconnected operations by leveraging increased automation, reducing the burden experienced by the warfighter, and providing accurate, actionable information.

The goal of Emerging and Enhanced Biothreat Sensing is to analyze wastewater for emerging biological threats and help foster early warning. Early warning will allow for more timely and useful consequence management operations (Vaccine development, diagnostic testing).

Developed threat sensing and sampling payloads for manned and unmanned aerial system (UAS) and ground (UGS) platforms to enhance early warning and situational awareness of chemical threats. Sensor development will support dismounted reconnaissance and surveillance missions by providing low size, weight, power and cost sensors or sensing/collection systems that are rugged, rapid and accurate.

The Operational Chemical Sensing thrust area will mature and miniaturize chemical threat sensing and sampling technologies for distributed and networked detection systems beyond the warfighter’s line of sight to support early warning of chemical threats for fixed site, reconnaissance, and maneuver operations. Furthermore, the thrust area will provide capabilities for the full spectrum of missions and threats with rugged, low-cost point sensors and automated technologies.

The Modernized and Enhanced Chemical Sensing thrust area will develop a suite of modernized detection technologies for traditional chemical threats while enhancing detection capabilities for non-traditional, emerging, and mixed chemical hazards. Furthermore, this thrust area will miniaturize high-fidelity identification instruments for field use, keeping the warfighter ahead of traditional and emerging chemical threats in complex environments.

Developed disruptive technologies to identify unknown or emerging chemical threats as well as sensors that can operate in complex threat environments with high accuracy. Efforts in this area pursue a “fail fast” approach, with promising technologies transferred to other thrust areas/budget lines for further development.

Provided general and specialized forces with the ability to modernize detection technologies for traditional threats while enhancing detection capabilities for non-traditional, emerging, and mixed chemical hazards.

The nerve agent (NA) prophylaxis portfolio is developing protective medicines that are effective against a broader range of nerve agents – including fourth generation agents – than had ever before been thought possible. Successful development of these medicines will greatly enhance the ability of the warfighter to stay in the fight and move forward.

This effort funds biomedical research focused on the evaluation and development of broadly-acting therapeutic countermeasures that support development of novel and repurposed therapeutic interventions.

Develop threat sensing and sampling payloads for manned and unmanned aerial system (UAS) and ground (UGS) platforms to enhance early warning and situational awareness of biological and chemical threats. Sensor development will support dismounted reconnaissance and surveillance missions by providing low size, weight, power and cost sensors or sensing/collection systems that are rugged, rapid and accurate. Early indications from capabilities under Chemical and Biological (CB) Reconnaissance will allow for enhanced warning of threats.

The Operational Biological Sensing Thrust Area aims to inform and alert the warfighter of biological hazards they may encounter in an operational setting. This thrust area continues to develop fieldable technologies capable of collecting and detecting air-borne biological threats in the battlespace.

Establish robust capability to assess emerging and enhanced biological threats to rapidly develop biosensors for detecting emerging or enhanced biological threats. Quickly develop adaptable, analyte-agnostic laboratory and field-forward detection capabilities to provide a spectrum of improved detection assets for novel threats. This thrust area leverages multi-omics data science or the combining multiple measurements to inform rational and rapid design and development of biodetection solutions. Synthetic biological concepts will be thoroughly evaluated and exploited for the development of biosensing solutions and refinement of laboratory methods.

Develops disruptive technologies to identify unknown or emerging biological threats as well as sensors that can operate in complex threat environments with high accuracy. Efforts in this area pursue a “fail fast” approach, with promising technologies transferred to other thrust areas/budget lines for further development.

Efforts in this area focus on exploring potential operational use of emerging technology concepts for potential applications to the warfighter. These efforts are conducted prior to and during development of models and prototypes, scope future Science & Technology (S&T) efforts, map future warfighter engagements, and how this capability may change the way the warfighter fights in the future operating environment.

Establish a layered defense capability by developing and implementing automated and integrated technologies enabling unattended monitoring for chemical and biological threats. These technologies will provide early warning of vapor, aerosol, solid, and liquid hazards and unencumber the warfighter by reducing logistics and operator burden. Providing a reliable detect-to-warn capability at fixed or expeditionary sites will enhance the overall protective posture of ground and maneuver forces as robust technologies can be miniaturized for portability and operational sustainment.

Provide non-invasive disease screening capabilities to rapidly respond to emerging biological threats and greatly enhance the warfighters' ability to seek medical treatment at the earliest indication of exposure.

Provide agile assay development capabilities aided by Artificial Intelligence (AI) to advance the speed and accuracy of diagnostic assay design, addressing a key functional capability needed for emerging biological threat response.

Provide end users with a rapid assay capability (< 6 weeks from discovery of emerging/enhanced threat to delivery of the initial assay) that will be disruptive to current detection and diagnostic timelines. Eliminate the need to rely on single-source reagents to rapidly respond to emerging biological threat.

Expand on agnostic disease screening and sensing capabilities for emerging biological threats.

Technical Surprise assesses technological advancements for potential implications to the threat space, including agent use and release. Technical Surprise includes horizon scanning to identify potential areas of concern as well as conducts technical assessments of emerging technological advancements (e.g. biotechnology, artificial intelligence, machine learning, quantum computing). This program develops capabilities to evaluate and assess technical enhancements that may alter the nature or magnitude of a threat agent. The technical surprise program evaluates technologies and convergence of technologies that improve the ease of threat use and make threats more likely to survive being released. The program identifies the limitations and barriers associated with synthetic biology and assesses the implications. Finally, these efforts identify and assess former technology hurdles that have been lowered or overcome and assesses the implications to the magnitude of the potential threat.

This area supports development and evaluation of lead Project PT2/Protect (Applied Research) platforms and capabilities (including broad-spectrum and rapid response).

Air purification filters go on individual protective gear (masks) and collective protection (i.e., military systems such as tanks, ships, and buildings). Current filters are expensive and do not alert operators when they are no longer effective at blocking Chemical and Biological (CB) threats. Air Purification Enhancements develops filters that last longer and reduce lifecycle costs, as well as devices to monitor their effectiveness throughout their lifecycle. The thrust area's filters will develop and mature enhanced protection technologies against both traditional and advanced threats.

Current individual protective gear can be uncomfortable to wear for extended periods of time and the gear can make it less natural to perform essential warfighting functions. All-Hazards and Respiratory Protection designs and develops reduced burden, low encumbrance respiratory and ocular (eye) protection. This will make it easier for the warfighter to perform mission essential tasks while operating in individual protective gear. Current CB protective masks don’t integrate with current optical sites and developmental optical systems, such as heads up displays. All-Hazards Respiratory Protection works to develop CB defense masks that integrate with these combat systems.

Creates military equipment coatings that make equipment easier to decontaminate. Develops and optimizes test methods, temporary equipment coatings, and other approaches that resist chemical agent absorption and are quickly decontaminated in the field for rapid reduction in Mission-Oriented Protective Posture (MOPP) and return to mission. Temporary coatings are intended to last longer than six months, up to the lifetime of the underlying coating.

Develops next generation protection materials for protective garments, masks, and filters. It identifies and tests new materials that absorb, neutralize, and repel chemical and biological warfare agents with high efficiency, which will reduce costs by extending service life. New materials can also reduce the heat burden of individual protection and make it more natural to operate. This will allow warfighters to operate in individual protection gear for extended periods of time, reducing the necessity of early warning. Multifunctional Materials for Protection (MMfP) replaces per- and polyfluoroalkyl substances (PFAS)-based textile finishes and surface coatings. MMfP begins manufacturing and scaling processes for technologies that transition to all physical protection thrust areas.

Advances garment material and ensemble technologies with revolutionary capability improvements using integrated, low encumbrance garment designs and fabrication processes for thermal burden reduction, greater mobility, longer service life, and simplified logistics. Incorporates state-of-the-art threat protection technologies and develops supporting test methodologies and methods that provide operationally relevant, consistently comparable test data on protective garments.

Develops, optimizes, demonstrates, and transitions technologies, guidelines, and engineering standards that extend collective protection filter life to reduce costs while maintaining or improving biological protection against traditional and emerging threats. Integrates new collective protection filters into developmental Service major combat platforms and Department of Defense (DoD) facilities.

Develops, optimizes, and transitions low cost, low burden, antimicrobial respiratory and ocular protection for operations specifically in a biologically contaminated environment.

Develops, optimizes, and transitions low cost, low burden, antimicrobial percutaneous protection for operations specifically in a biologically contaminated environment.

Vaccine Acceleration by Modular Progression-Enhanced Biological Defense (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.

Funds biomedical research focused on the nonclinical and early clinical development of repurposed therapeutic countermeasures.