MEDICAL BIOLOGICAL DEFENSE (EMD)
Abstract
This project includes medical countermeasures, development of reagents, assays, diagnostic equipment, biosurveillance and supporting efforts. Biosurveillance programs align the biosurveillance efforts across the DoD and national strategies. The BSV program will scope and influence BSV capabilities as products to meet Warfighter requirements through innovative management of key BSV initiative. BSV will also support the Joint US Forces Korea (USFK) Portal and Integrated Threat Recognition (JUPITR) 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 laboratory to operational use. Depending on the maturity, outputs will focus on providing component, CONOPS, and subsystem transition into programs of record (PORs) and/or integration into existing PORs. Technologies identified from the JUPITR ATD will be fielded in FY16 to Pacific Command (PACOM). Future ATD developments will continue to bridge communication gaps between US Forces across other Combatant Command (COCOMs). The Biosurveillance (BSV) program will transfer from the Medical Countermeasures (MB) Project to the Contamination Avoidance (CA) Project effective FY 2016. The Critical Reagents Program's (CRP) strategy establishes a core research and development capability by developing biological threat agent reference materials (strains, antigens, antibodies and nucleic acids) and detection/diagnostic assays for biothreat agent detection. These reagents/assays are leveraged across multiple programs to meet the requirements of the Warfighter and Joint biological defense systems and support the biological defense community. Through the Targeted Acquisition of Reference Materials Augmenting Capabilities (TARMAC) initiative, the CRP will use a systematic approach to the introduction of new materials and information into MCM 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. The first indication being pursued is influenza 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. It 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 EMD phase. EID Tx will leverage on going filovirus countermeasure development 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. This work will be funded by the Antiviral Therapeutic programs. 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 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 were the focus of the TMRR phase. FDA approval for Filovirus therapeutics are expected following completion of the EMD phase. Beginning in FY17, the work will be continued under the Antiviral Therapeutic Countermeasures program. The Antiviral Therapeutic Program will combine the efforts of the Emerging Infectious Diseases Therapeutics 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. The program will conduct human clinical safety studies, pilot and pivotal animal efficacy, and toxicology studies, required for FDA approval. The performers will submit New Drug Applications/Biologic License Agreements for the therapeutics during the EMD Phase. During the Production and Deployment phase, full rate manufacturing and stockpile production will be pursued. If the FDA mandates post-marketing surveillance studies, they will be conducted during Production and Deployment. 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 FDA-cleared diagnostics to inform individual patient treatment and CBR situational awareness and disease surveillance. NGDS Increment 1 will significantly improve diagnostic capabilities for deployable combat health support units (Role 3) while also improving operational suitability and affordability. The term "Role" is used to describe the stratification of the four tiers in which medical support is organized, on a progressive basis, to conduct treatment, evacuation, resupply, and functions essential to the maintenance of the health of the force. Role 3 support is normally provided at Division or Service equivalent level and includes specialist laboratory resources. 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 DoD provides for the development of 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 BW agents. Vaccines have been identified as the most efficient countermeasure against the validated threat of BW weapons. Products under development in this budget item include Recombinant Botulinum A/B, Plague, and Filovirus vaccines. Efforts to be conducted during the Engineering Manufacturing Development (EMD) Phase include the development of large scale manufacturing process and validation of that process, nonclinical studies, demonstration of manufacturing consistency, and expanded clinical human safety studies. The results of these efforts, and those conducted during the EMD phase, will be used to submit a Biologic License Application (BLA) to the Food and Drug Administration (FDA) for product licensure. To evaluate vaccine effectiveness, pivotal animal studies will be conducted concurrently with the Phase 3 clinical trial to satisfy the requirements of the FDA's "Animal Rule". 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). Upon FDA licensure, the product will transition to full-scale licensed production. The DoD also has the mission to maintain Investigational New Drug (IND) vaccines in Good Manufacturing Practice (GMP) storage and to conduct the periodic potency and sterility testing of these materials to support submissions to the FDA. These IND vaccines will be used to provide additional levels of protection to laboratory workers in the Special Immunizations Program (SIP) conducting research on these diseases.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2017
- Source ID
- MB5_0604384BP_5_0400_PB_2017
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
- Child Accomplishment: 1) AV TX - Candidate 1 (Filovirus TRL 6)
- Child Accomplishment: 2) BSV
- Child Accomplishment: 3) BSV
- Child Accomplishment: 4) CRP
- Child Accomplishment: 5) CRP
- Child Accomplishment: 6) CRP
- Child Accomplishment: 7) CRP
- Child Accomplishment: 8) CRP
- Child Accomplishment: 9) DFAS EFD ADJUSTMENT
- Child Accomplishment: 10) EID TX
- Child Accomplishment: 11) EID TX
- Child Accomplishment: 12) EID TX
- Child Accomplishment: 13) EID TX
- Child Accomplishment: 14) EID TX
- Child Accomplishment: 15) EID TX
- Child Accomplishment: 16) HFV
- Child Accomplishment: 17) HFV
- Child Accomplishment: 18) HFV
- Child Accomplishment: 19) DFAS EFD ADJUSTMENT
- Child Accomplishment: 20) NGDS - Increment 2
- Child Accomplishment: 21) NGDS - Increment 2
- Child Accomplishment: 22) NGDS - Increment 2
- Child Accomplishment: 23) NGDS - Increment 2
- Child Accomplishment: 24) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 25) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 26) VAC BOT
- Child Accomplishment: 27) DFAS EFD ADJUSTMENT
- Child Accomplishment: 28) VAC FILO
- Child Accomplishment: 29) VAC FILO
- Child Accomplishment: 30) VAC PLG
- Child Accomplishment: 31) VAC PLG
- Child Accomplishment: 32) VAC PLG
- Child Accomplishment: 33) VAC PLG
- Child Accomplishment: 34) DFAS EFD ADJUSTMENT
- Child Accomplishment: 35) VAC SIP
- Child Accomplishment: 36) SBIR/STTR
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