MEDICAL BIOLOGICAL DEFENSE (EMD)
Abstract
This project includes medical countermeasures, development of reagents, assays, diagnostic equipment, biosurveillance and supporting efforts. The Defense Biological Products Assurance Program (DBPAP) 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 DBPAP 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 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 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 Antiviral Therapeutic Program (AV TX) will develop and deliver FDA approved antiviral therapeutics for the warfighter. 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. Medical Countermeasure Platform Technologies (MCMPT) will leverage platform technologies to streamline the MCM delivery to the Force by reducing developmental risk and a subset of these technologies will be adapted to deliver a rapid response capability to novel and emerging threats. The first platform being established as part of an Advanced Technology Demonstration (ATD) is the Advanced Development and Manufacturing Antibody Technologies (ADAMANT). A second platform technology will be established which will focus on a vaccine platform capability. 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 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 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 2 will provide additional capability for diagnosis of CBR-induced diseases, suitable for use in far forward environments. 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 Next Generation Anthrax 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 Next Generation Anthrax vaccine 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, 2019
- Source ID
- MB5_0604384BP_5_0400_PB_2019
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
- Child Accomplishment: 1) MCMPT
- Child Accomplishment: 2) MCMPT
- Child Accomplishment: 3) CMDR-B
- 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) CRP
- Child Accomplishment: 8) CRP
- Child Accomplishment: 9) CRP - ADAMANT
- Child Accomplishment: 10) CRP
- Child Accomplishment: 11) CRP
- Child Accomplishment: 12) CRP
- Child Accomplishment: 13) DBPAP
- Child Accomplishment: 14) DBPAP
- Child Accomplishment: 15) DBPAP
- Child Accomplishment: 16) DBPAP
- Child Accomplishment: 17) DBPAP
- Child Accomplishment: 18) EID TX
- Child Accomplishment: 19) AV TX
- Child Accomplishment: 20) AV TX
- Child Accomplishment: 21) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 22) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 23) VAC BOT
- Child Accomplishment: 24) VAC NGA
- Child Accomplishment: 25) VAC PLG
- Child Accomplishment: 26) VAC PLG
- Child Accomplishment: 27) VAC PLG
- Child Accomplishment: 28) VAC PLG
- Child Accomplishment: 29) VAC SIP
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