MEDICAL BIOLOGICAL DEFENSE (ACD&P)
Abstract
This project includes medical countermeasures, development of reagents, assays, diagnostic equipment, biosurveillance and supporting efforts. This Advanced Component Development and Prototypes (ACD&P) Project supports: The Antiviral Therapeutics (AV TX) Program will combine the efforts of the Emerging Infectious Diseases Therapeutics Program and the Hemorrhagic Fever Virus Program into a consolidated effort to develop and deliver FDA approved antiviral therapeutics for the warfighter, beginning in FY17. Drug products will be developed targeting the pathogens on the biological warfare threat lists, such as Ebola. This includes viruses of interest from the following families: Filoviridae, Alphaviridae, Arenaviridae, Bunyaviridae, and Flaviviridae. Developed antiviral therapeutics will be employed after suspected or confirmed exposure to the relevant threat agents and AV TX 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. The Medical Countermeasure BSL-4 GLP Test and Evaluation capability performs T&E and provides the essential data packages to support US Food and Drug Administration approval of leading biodefense medical countermeasure candidates to protect the Warfighter and the Nation. This capability provides dedicated capacity for DoD to conduct biosafety level-4 (BSL-4) Good Laboratory Practice (cGLP) T&E studies to meet programmatic needs following all applicable regulatory, biosurety, and safety standards. 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 (MCMPT) capability. The goal of the MCMPT is to counter a variety of threat agents using standardized discovery, design, manufacturing, and testing processes to reduce the MCM development risks. Efforts will center on leveraging the DoD's Advanced Development Manufacturing (ADM) facility and developing robust manufacturing processes. The Countermeasures for Multi-Drug Resistance-Bacterial (CMDR-B) program develops medical countermeasures (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 US Food and Drug Administration (FDA)-approved to prevent or minimize effects of MDR bacterial exposures. The NGDS Family of Systems program provides Chemical, Biological and Radiological (CBR) threat and infectious disease diagnostic capabilities across several echelons of care, as well as for environmental sample analysis as part of the Common Analytical Laboratory System (CALS). The NGDS Increment 1 provides an U.S. Food and Drug Administration (FDA)-cleared reusable, portable biological pathogen diagnostic system to Army, Air Force and Navy deployable Combat Health Support units, to support near real-time patient treatment decision making, force health protection decision making and CBRN situational awareness. 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. The Department of Defense (DoD) supports the Technology Maturation and Risk Reduction (TMRR) phase for vaccines that are directed against validated biological warfare (BW) weapons to include bacteria, viruses, and toxins of biological origin. Effective medical countermeasures are urgently needed to negate the threat of these biological warfare (BW) agents. Vaccines have been identified as the most efficient countermeasure against the validated threat of BW weapons. The Filovirus Vaccine (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 S&T further develops Ebola vaccine candidates to meet the DoD requirement. The current budget supports development of multiple Marburg prototypes to protect against the BW threat through TMRR phase. The DoD anticipates that the Food and Drug Administration (FDA) will approve a vaccine using the Animal Rule, which allows for the demonstration of efficacy in a relevant animal model(s). The Ricin toxin is a validated bioweapon threat that is lethal, available and easily produced. The Ricin vaccine program (VAC Ricin) supports one DoD vaccine candidate including manufacturing cGMP lots; and the continuation of animal model and assay development studies. The Ricin Vaccine will protect the Warfighter against aerosolized exposure to ricin toxin. The Western, Eastern, and Venezuelan Equine Encephalitis (VAC WEVEE) Vaccine program initiated competitive prototypes in FY13 to reduce program risk, and is developing multiple prototypes through the Technology Development Phase. The Western, Eastern, and Venezuelan Equine Encephalitis (VAC WEVEE) Vaccine will protect the Warfighter against aerosolized exposure to three strains of alphaviruses; western, eastern and Venezuelan equine encephalitis viruses. The program office is prioritizing the development and delivery of a licensed VEE vaccine. Anthrax is a validated bioweapon threat for which the Force is being vaccinated against. The current anthrax dose schedule requires up to 6 doses to be fully protective. Health and Human Services has developed a next generation vaccine for post exposure to anthrax. The DoD is seeking to leverage HHS development efforts and extend the label to pre-exposure to anthrax. This will allow both the civilian and military populations to maintain the same standard of care.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2018
- Source ID
- MB4_0603884BP_4_0400_PB_2018
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (ACD&P)
- Child Accomplishment: 1) MCMPT
- Child Accomplishment: 2) BSL-4 GLP T&E
- Child Accomplishment: 3) CMDR-B
- Child Accomplishment: 4) CMDR-B
- Child Accomplishment: 5) CMDR-B
- Child Accomplishment: 6) NGDS 2 Family of Systems
- Child Accomplishment: 7) VAC FILO
- Child Accomplishment: 8) VAC FILO
- Child Accomplishment: 9) VAC FILO
- Child Accomplishment: 10) VAC FILO
- Child Accomplishment: 11) VAC NGA
- Child Accomplishment: 12) VAC RIC
- Child Accomplishment: 13) VAC WEVEE
- Child Accomplishment: 14) VAC WEVEE
- Child Accomplishment: 15) VAC WEVEE
- Child Accomplishment: 16) VAC WEVEE
- Child Accomplishment: 17) AV TX - Candidate 2
- Child Accomplishment: 18) AV TX Candidate 2
- Child Accomplishment: 19) AV TX Enabling Technology
- Child Accomplishment: 20) AV TX Enabling Technology
- Child Accomplishment: 21) AV TX Enabling Technology
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