MEDICAL BIOLOGICAL DEFENSE (EMD)
Abstract
This project includes medical countermeasures, development of reagents, assays, diagnostic equipment, biosurveillance and supporting efforts. The Critical Reagent 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 CRP program will transition to the Defense Biological Products Assurance Program (DBPAP) in FY18. 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 product in development failed during phase 3 clinical trials as a result the flu effort is being terminated. The development of a broad spectrum medical countermeasure will continue under the Antiviral Therapeutic program. 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 (AV TX) 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. 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 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 focus on establishing a rapid response capability through rationale design to support identification of viral targets and development of protein expression processes that will support rapid response. 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 for the Recombinant Botulinum A/B, Plague, and Filovirus programs 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, 2018
- Source ID
- MB5_0604384BP_5_0400_PB_2018
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
- Child Accomplishment: 1) MCMPT
- Child Accomplishment: 2) NGDS 2
- Child Accomplishment: 3) NGDS 2
- Child Accomplishment: 4) NGDS 2
- Child Accomplishment: 5) NGDS 2
- Child Accomplishment: 6) NGDS 2 In Vitro Diagnostic Assay Development and Maturation
- Child Accomplishment: 7) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 8) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 9) VAC BOT
- Child Accomplishment: 10) VAC FILO
- Child Accomplishment: 11) VAC FILO
- Child Accomplishment: 12) VAC PLG
- Child Accomplishment: 13) VAC PLG
- Child Accomplishment: 14) VAC PLG
- Child Accomplishment: 15) VAC PLG
- Child Accomplishment: 16) VAC SIP
- Child Accomplishment: 17) CRP
- Child Accomplishment: 18) CRP
- Child Accomplishment: 19) CRP
- Child Accomplishment: 20) CRP
- Child Accomplishment: 21) CRP
- Child Accomplishment: 22) DBPAP - Select Agent Reference Materials
- Child Accomplishment: 23) DBPAP - Development of Immunoassays
- Child Accomplishment: 24) DBPAP - QA/QC Testing
- Child Accomplishment: 25) DBPAP - Accreditation Audits
- Child Accomplishment: 26) DBPAP - Unified Culture Collection
- Child Accomplishment: 27) EID TX
- Child Accomplishment: 28) EID TX
- Child Accomplishment: 29) HFV
- Child Accomplishment: 30) HFV
- Child Accomplishment: 31) AV TX - Candidate 1
- Child Accomplishment: 32) AV TX Candidate 1
- Child Accomplishment: 33) AV TX Candidate 1
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