MEDICAL BIOLOGICAL DEFENSE (ACD&P)
Abstract
This Advanced Component Development and Prototypes (ACD&P) Project supports: The Medical Countermeasure Test and Evaluation (MCM T&E) 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. Biosurveillance (BSV) actively gathers, analyzes, and interprets collected information that includes biosphere data that relate to disease activity and threats to human or animal health in order to achieve early warning of health threats, early detection of health events, and overall situational awareness of disease activity. BSV will align the biosurveillance efforts across DoD and national strategies. BSV will scope and influence BSV capabilities as products to meet Warfighter requirements through innovative management of key BSV initiatives. BSV requirements address medical and physical CBRN mission needs spanned in over 11 requirements documents and through Combatant Commander (COCOM) identified needs. BSV funds will support Joint US Forces Korea (USFK) Portal and Integrated Threat recognition (JUPITR) ATD/BSV ATD which will find, demonstrate, transition, and transfer the best operational concepts and technology solutions in support of a holistic approach to countering biological threats from the laboratory to operational use and theater confirmation of a Biological Event. JUPITR ATD will consist of four legs; Early Warning (EW), Biological Identification Capabilities Sets (BICS), Assessment of Environmental Detectors (AED), and Biosurveillance Portal (BSP). The JUPITR ATD will provide the USFK with a holistic biosurveillance capability to provide early warning, detection, collection, identification, and theater confirmation of a Biological event. The JUPITR ATD consists of filling capability gaps through information sharing and communication systems and detection/diagnostic systems for the USFK. Outputs will focus on proving component, CONOPS, and subsystem transition into programs of record (PORs) and/or integration into existing PORs. Excursion for whole system live agent test (WSLAT) of AED units will support JPM NBC CA Mission for Point Biological Detection. The Biosurveillance (BSV) program will transfer from the Medical Countermeasures (MB) Project to the Contamination Avoidance (CA) Project effective FY 2016. 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. The resulting products(s) will be US Food and Drug Administration (FDA)-approved to prevent or minimize effects of MDR bacterial exposures. Leveraging collaborative Department of Defense (DoD), United States Government, and industry efforts will reduce program risk, lower program cost, and accelerate the delivery of therapeutics to the Warfighter. The program has established a translational team with the Joint Science and Technology Office for animal model work and pipeline candidates that could transition to CMDR-B for Advanced Development. The Emerging Infectious Diseases Therapeutics (EID Tx) program is developing and will deliver a Food and Drug Administration (FDA) approved, broad-spectrum medical countermeasure to the Warfighter for protection against naturally occurring or biologically engineered viruses. EID Tx is pursuing influenza indication as the first step in the development of a broad spectrum antiviral drug due to a clear and established FDA regulatory approval pathway. The drug in development is highly efficacious against multiple influenza viruses, including the 2009 H1N1 pandemic virus, H5N1 avian influenza virus, the most recently identified H7N9 virus from the outbreak in China, and drug resistant strains of influenza viruses. This drug has also demonstrated efficacy against other viruses of concern to the DoD's biodefense program. FDA approval for an influenza treatment is anticipated following completion of the SDD phase. Ongoing EID Tx drug development will be leveraged to demonstrate additional broad-spectrum MCM's against naturally occurring and/or engineered biowarfare threats. To meet the mission need of "one drug, many bugs" EID Tx is testing product efficacy on BWA threats. This will allow the military to leverage a product that will be FDA approved for influenza against other viruses. The Hemorrhagic Fever Virus (HFV) MCS Acquisition Program develops medical countermeasures (MCMs), using high threat, extremely lethal Biological Warfare Agents (BWAs) of the Filoviridae family agents (Ebola) as a model system. Medical countermeasures will be advanced through the Food and Drug Administration (FDA) licensure/approval via the FDA 'Animal Rule', which allows for the demonstration of efficacy in relevant animal model(s) when human testing is not ethically feasible. HFV will also conduct animal model development and refinement as needed to support the pivotal animal efficacy testing required under the FDA 'Animal Rule'. Completion of Phase I trials, animal model development, and manufacturing scale up are the focus of the ACD&P phase. FDA approval for Filovirus therapeutics are expected following completion of the SDD phase. The NGDS is an evolutionary acquisition family of systems to provide increments of capability over time across many echelons of the Combat Health Support System. The mission of the NGDS is to provide Chemical, Biological and Radiological (CBR) threat and infectious disease identification and U.S. Food and Drug Administration (FDA)-cleared diagnostics to inform individual patient treatment as defined in the approved NGDS Capabilities Development Document (CDD) and CBR situational awareness and disease surveillance as defined in the Common Analytical Laboratory (CALS) CDD. NGDS Increment 1 (NGDS Inc 1) will significantly improve diagnostic capability for deployable combat health support units (Role 3) while also improving operational suitability and affordability by developing FDA cleared biological warfare agent (BWA) and infectious disease in vitro diagnostic (IVD) assays on existing commercial diagnostic device with a well established FDA regulatory history and pipeline of commercial non-BWA infectious disease diagnostic tests. The NGDS Inc 1 program has a streamlined MS A to MS C - Limited Deployment acquisition strategy. BA4 funds support the NGDS Increment 1 program through the Technology Maturation and Risk Reduction phase to complete competitive prototyping activities, initiate development of six BWA IVDs (Anthrax, Ebola, Marburg, Plague, Tularemia and Q-Fever), initiate the development of BWA environmental surveillance assays, multiservice operational test assessment, and Urgent Material Release of systems and Ebola emergency use diagnostic test in support of the DoD's Ebola Response and Preparedness initiative under Title X. NGDS Increment 2 will complement NGDS Increment 1 by developing diagnostics biological pathogens and toxins, and addressing diagnostics for chemical and radiological exposures, and to provide capability to lower echelons of care. NGDS Increment 2 will also conduct collaborative work with the Defense Advanced Research Project Agency to accelerate development of a ruggedized Ebola detection and diagnostic system for use in austere environments in support of the DoD's Ebola Response and Preparedness initiative under Title X. The Department of Defense (DoD) funds the technology development phase for vaccines that are directed against validated biological warfare (BW) weapons to include bacteria, viruses, and toxins of biological origin. Effective medical countermeasures to negate the threat of these biological warfare (BW) agents are urgently needed. Vaccines have been identified as the most efficient countermeasure against the validated threat of BW weapons. The multiple Trivalent Filovirus Vaccine (VAC FILO) Program will offer protection against the threat of Ebola and Marburg viruses. The current budget supports development and acceleration of two multiple candidates, in response to the Ebola outbreak, to provide an interim fielding capability, through the Technology Development Phase. The DoD anticipates that the Food Drug Administration (FDA) will approve this vaccine using the 'Animal Rule', which allows for the demonstration of efficacy on relevant animal model(s). During this phase a scalable manufacturing process is developed. This process will be used to develop current Good Manufacturing Practices (cGMP) lots suitable for a Phase 1 clinical trial. In addition, animal safety and efficacy studies will be conducted to support an Investigational New Drug (IND) submission to the FDA. These efforts will support a Milestone B decision and entry into the Engineering, Manufacturing, and Development (EMD) phase. The DoD is the Public Health Emergency Countermeasures lead for the advanced development of the Filovirus Vaccine. The Ricin toxin is a validated bioweapon threat due to its availability and efficiency of production. The program supports one DoD vaccine candidate including manufacturing cGMP lots; and the continuation of animal model and assay development studies. These efforts also include a Phase 1b clinical trial, regulatory integration, and a manufacturing technology transfer to the ADM capability. The DoD is the Public Health Emergency Countermeasures lead for the advanced development of the Ricin Vaccine. The Western, Eastern, and Venezuelan Equine Encephalitis (VAC WEVEE) Vaccine program initiated competitive candidates in FY13 to reduce program risk, and is developing two candidates through the Technology Development Phase. The efforts to be conducted during this period include: develop pilot scale manufacturing processes and manufacture of cGMP lots to support nonclinical and clinical studies; develop vaccine formulation that meets the logistical requirements of the DoD; conduct non-clinical GLP safety studies; submit Investigational New Drug (IND) applications; and conduct Phase 1 clinical human safety studies. The DoD anticipates that the FDA will approve these products using the 'Animal Rule', which allows for the demonstration of efficacy in relevant animal model(s). These efforts will support a Milestone B decision and entry into the EMD phase. The DoD is the Public Health Emergency Countermeasures lead for the advanced development of the WEVEE Vaccine. FY 2015 funding includes $89.1 million of base funding and $17.3 million of Ebola emergency funding.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2016
- Source ID
- MB4_0603884BP_4_0400_PB_2016
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- Root: CHEMICAL/BIOLOGICAL DEFENSE (ACD&P)
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