Medical Biological Defense (ACD&P)
Abstract
This project includes Medical Countermeasure platform technologies, Medical Countermeasures (vaccines and therapeutics), development of reagents, assays, diagnostic equipment, biosurveillance and supporting efforts. Efforts included in this project are: (1) Biosafety Level 4 Good Laboratory Practice Test and Evaluation (BSL4 GLP T&E) (2) Chem Bio Incident Preparedness and Response - Biosafety Level 4 Research Institute of Infectious Diseases (CBIPR - BSL4 RIID) (3) Chem Bio Incident Preparedness and Response - Advanced Development and Manufacturing (CBIPR - ADM) (4) Countermeasures for Multi-Drug Resistance-Bacterial (CMDR-B) (5) Medical Countermeasure Platform Technologies (MCMPT) (6) Next Generation Diagnostic System 2 (NGDS Increment 2) (7) NGDS 2 Chemical Diagnostics (NGDS 2 CHEMDX) (8) Filovirus Vaccine (VAC FILO) (9) Venezuelan Equine Encephalitis (VAC VEE) The Medical Countermeasure BSL-4 GLP T&E capability performs T&E and provides the essential data packages to support US Food and Drug Administration (FDA) approval of leading biodefense medical countermeasure candidates to protect the Warfighter and the Nation. This capability provides dedicated capacity at U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) for Department of Defense (DoD) to conduct biosafety level studies to meet programmatic needs following all applicable regulatory, biosurety, and safety standards. The capability building effort at the DoD ADM will establish and enhance proven biopharmaceutical and vaccine manufacturing technologies to accelerate the delivery of medical countermeasures as part of a medical integrated layered defense. The return on investment is an increased level of preparedness and responsiveness to counter current and emerging chemical and biological threats. By establishing and enhancing proven enabling technologies, the DoD ADM will accelerate development of medical countermeasures (MCMs) at all stages of development, enhance preparedness for existing threats, and accelerate response to emerging threats. MCMs impacted by these efforts include: Vaccines for Viral Agents, Vaccines for Bacterial Agents and Toxins, Monoclonal antibodies, antibody fragments, and antibody conjugates for therapeutic and prophylactic use across all agent classes, and Adjuvants. Funds to support the state of readiness were previously provided through individual product development and manufacturing funding lines. The Department is providing dedicated funds (CBIPR-ADM) to support operational availability. The CMDR-B program develops MCMs for Service members for protection against multi-drug resistant (MDR) bacteria, including Biological Warfare Agents (BWAs) and organisms that are genetically modified to be MDR and resulting bio-toxins. The resulting product(s) will be FDA approved to prevent or minimize effects of MDR bacterial exposures. The candidate drug was approved by the FDA in Oct 2018 for Community Acquired Bacterial Pneumonia (CAPB) that was required as part of the acquisition strategy for the antibiotic repurposing program from S&T to advanced development. MCMPT is establishing enabling technologies and pre positioning platform systems at the DoD's Advanced Development Manufacturing (ADM) facility using standardized discovery, design, manufacturing, and testing processes to reduce the medical countermeasure (MCM) development risks. Efforts will center on leveraging the ADM's facility and developing robust manufacturing processes. MCMPT will leverage platform technologies to streamline and accelerate the MCM delivery to the Force by reducing developmental risk. A subset of these technologies will be adapted to deliver a rapid response capability to novel and emerging threats. Through the Advanced Development and Manufacturing Antibody Technologies (ADAMANT) and Rapid Response platforms, MCMPT will deliver an enduring capability from which future candidates can be manufactured. The Agile Medical Paradigm (AMP) is the CBDP's strategic framework to accelerate the delivery of MCMs. To achieve this goal the DoD is establishing a medical countermeasures platform technology (MCMPT) capability. The NGDS is a family of systems providing increments of diagnostic capabilities over time that address varied chemical, biological and radiological (CBR) threats across the different echelons of the Combat Health Support System. The mission of the NGDS is to provide CBR threat and infectious disease identification and FDA-cleared diagnostics to inform individual patient treatment and CBR situational awareness and disease surveillance. NGDS Increment 1 improves diagnostic capabilities in deployable and laboratory-based combat health support units. NGDS Increment 1 offers improved operational suitability and affordability over legacy systems by developing FDA cleared biological warfare agent (BWA) and infectious disease in vitro diagnostic (IVD) assays on an existing commercial diagnostic device with a well-established FDA regulatory history and pipeline of commercial non-BWA infectious disease diagnostic tests. NGDS Increment 2 will complement NGDS Increment 1 by developing diagnostics for unmet biological pathogen and toxin threats, chemical and radiological exposures, and to provide capability to lower echelons of care. NGDS Increment 2 will provide additional capability for diagnosis of CBR-induced diseases, suitable for use in far forward environments, by developing lightweight, portable, and simple-to-use instruments and test kits. In FY21 NGDS Increment 2 has been broken out into two separate programs; NGDS 2 Man Portable Diagnostic System (MPDS) Program and NGDS 2 CHEMDX Program. NGDS 2 MPDS will complement NGDS Increment 1 by providing a lightweight, portable, and simple-to-use diagnostic capability to end-users in non-laboratory, far-forward environments. NGDS 2 CHEMDX will provide a lightweight, portable, and simple-to-use diagnostic capability to end-users in non-laboratory, far-forward environments. The VAC FILO Program develops vaccines that will offer protection against the threat of Ebola and Marburg viruses. The program office is prioritizing the development and delivery of a licensed Marburg vaccine while working with Science & Technology (S&T) to further develop Ebola vaccine candidates to meet the DoD requirement. The current budget supports responsibly shelving program development efforts until prototype transition from our S&T partners. The DoD anticipates that the FDA will approve a vaccine using the Animal Rule, which allows for the demonstration of efficacy in a relevant animal model(s). The VAC VEE Program develops a vaccine that will protect the Warfighter against aerosolized exposure to the alphavirus Venezuelan equine encephalitis. Additionally, the Program Office will partner with Health and Human Services/National Institute of Allergies and Infectious Diseases (HHS/NIAID), DoD agencies, and laboratories to include U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Defense Threat Reduction Agency (DTRA), Joint Science Technology Office (JSTO) and other agencies. This DoD program is the Public Health Emergency Medical Countermeasures lead for the advanced development of this vaccine and is leveraging expertise across the Federal and International sectors to ensure programmatic success.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2021
- Source ID
- MB4_0603884BP_4_0400_PB_2021
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- Root: CHEMICAL/BIOLOGICAL DEFENSE (ACD&P)
- Child Accomplishment: 1) BSL-4 GLP Test & Evaluation
- Child Accomplishment: 2) CBIPR-BSL4 RIID
- Child Accomplishment: 3) CBIPR - ADM
- Child Accomplishment: 4) Countermeasures for Multi-Drug Resistance-Bacterial (CMDR-B)
- Child Accomplishment: 5) Medical Countermeasure Platform Technologies (MCMPT)
- Child Accomplishment: 6) MCMPT
- Child Accomplishment: 7) MCMPT
- Child Accomplishment: 8) Next Generation Diagnostic System 2 (NGDS 2)
- Child Accomplishment: 9) NGDS 2 Chemical Diagnostics (NGDS 2 CHEMDX)
- Child Accomplishment: 10) Filovirus Vaccine (VAC FILO)
- Child Accomplishment: 11) VAC FILO
- Child Accomplishment: 12) Venezuelan Equine Encephalitis (VAC VEE)
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