Protect (ACD&P)
Abstract
The Protect Advanced Component Development and Prototypes (ACD&P) Project provides the ability to shield the Joint Force from harm caused by Chemical Biological Radiological and Nuclear (CBRN) hazards by preventing or reducing individual and collective exposures, applying prophylaxis to prevent or mitigate negative physiological effects, and protecting critical equipment. In FY 2023, the Chemical Biological Defense Program (CBDP) RDT&E Projects were restructured to align with the CBDP portfolio construct. PT4 efforts in FY 2022 remain in Projects IP4, MB4, and TM4. This restructuring provided standardization and alignment across CBDP research, development and acquisition efforts. Efforts included in this Project are: (1) Accelerated Antibodies-Enhanced Biodefense (AA-ENBD) (2) Biological Warfare Defense Prototype (BIOPROTO) (3) Generative Unconstrained Intelligent Drug Engineering-Enhanced Biodefense (GUIDE-ENBD) (4) Medical Countermeasure Platform Technologies (MCMPT) (5) Plague Monoclonal Antibodies (PLG MAB) (6) Uniform Integrated Protective Ensemble Family of Systems Footwear (UIPE FoS Footwear) (7) Vaccine Acceleration by Modular Progression-Enhanced Biodefense (VAMP-ENBD) The Accelerated Antibodies - Enhanced Biodefense (AA-ENBD) will develop prophylactic and therapeutic monoclonal antibody (mAb) Medical Countermeasure (MCM) against a broad range of biological threats. Funded in FY22 as COVID Therapies Monoclonal Antibodies (COVID TX MAB), this is a continuation which will target the discovery, identification and small scale manufacture of mAbs with sufficient material to support non-clinical and clinical testing. Sufficient doses will be produced and maintained for potential use in emergency response situations. AA-ENBD was formerly known as Monoclonal Antibodies Therapeutics-Enhanced Biodefense (MAB TX-ENBD). The Biological Warfare Defense Prototype (BIOPROTO) supports early-phase clinical development and supporting non-clinical safety, tolerability and toxicity data for candidate vaccines and therapeutic drugs prior to transition to System Development & Demonstration. This work provides safe and effective medical defense against validated biological threat agents and emerging infectious disease biothreats including bacteria, toxins, and viruses. This work also involves the evaluation of Food and Drug Administration (FDA) approved therapeutics for operational use, as well as generation of novel drug products and formulations, to enhance level of protection and/or operational utility for the Warfighter. This effort reduces programmatic risk of failure in the advanced development phase. The Generative Unconstrained Intelligent Drug Engineering - Enhanced Biodefense (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 impacts the discovery and design of biologics products (e.g., monoclonal antibodies and vaccines) and small molecule drugs through a multi-faceted optimization process capturing critical quality attributes of safety, efficacy, manufacturability and pharmacokinetics/pharmacodynamics (PK/PI). Furthermore, GUIDE incorporates computational approaches to manufacturing controls and preclinical/clinical testing. GUIDE is a collaboration between the interagency, academia and industry partners and is integrated to the Accelerated Antibodies and RNA vaccine (VAMP) programs. In FY24 GUIDE will continue to develop a fully integrated computational approach to accelerating medical countermeasure development. The Medical Countermeasure Platform Technologies (MCMPT) program streamlines and accelerates delivery of medical countermeasure to the Warfighter against known and emerging biological threats by establishing mature platform technologies that allow for rapid response and by reducing developmental risks. MCMPT is establishing enabling technologies and prepositioning platform systems within the Department of Defense (DoD)'s Advanced Development Manufacturing (ADM) network using standardized discovery, design, manufacturing, and testing processes to reduce the medical countermeasure (MCM) development risks. MCMPT will deliver an enduring capability from which future candidates can be manufactured. The Plague Monoclonal Antibodies (PLG MAB) program was transitioned in FY2023 from MCMPT Advanced Development and Manufacturing of Antibody Technology (ADAMANT), PLG MAB will provide a pre-exposure monoclonal antibody product to protect the Warfighter from aerosolized plague and is intended for intramuscular route of administration. This capability is complementary to plague therapeutics and will provide a continuum of protection against plague bacteria. In FY24 PLG MAB continues monoclonal antibody discovery and half-life extensions to produce product to support a Phase 1 clinical study. The Uniform Integrated Protective Ensemble Family of Systems Footwear (UIPE FoS Footwear) will provide the warfighter with percutaneous protection against liquid, vapor, dust, particulate, or sporulated toxic material, chemical and biological warfare agents and radiological fallout particles when worn as part of the Uniform Individual Protection Ensemble (UIPE). In FY24 UIPE FoS Footwear will initiate prototype development to evaluate up to ten footwear alternatives, conduct chemical agent swatch testing to inform initial down select of alternatives, conduct limited early user testing to garner feedback on service preferred alternatives and generate documentation for Milestone B 2QFY25. The Vaccine Acceleration by Modular Progression - Enhanced Biodefense (VAMP-ENBD) will leverage 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 partnership, VAMP will continue to build the Warfighter's bio-armor to protect against biological threat families. VAMP will continue to develop alternative vaccine platform technologies and manage awards utilizing go/no-go checkpoints along the development pathway.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2024
- Source ID
- PT4_0603884BP_4_0400_PB_2024
Related Documents
- Root: Chemical and Biological Defense Program - Dem/Val
- Child Accomplishment: 1) AA-ENBD
- Child Accomplishment: 2) BIOPROTO
- Child Accomplishment: 3) GUIDE-ENBD
- Child Accomplishment: 4) MCMPT
- Child Accomplishment: 5) MCMPT
- Child Accomplishment: 6) MCMPT
- Child Accomplishment: 7) PLG MAB
- Child Accomplishment: 8) UIPE FoS Footwear
- Child Accomplishment: 9) VAMP-ENBD
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