MEDICAL BIOLOGICAL DEFENSE (EMD)
Abstract
This project supports Engineering and Manufacturing Development and Low Rate Initial Production (EMD/LRIP) of medical countermeasures, development of reagents, assays, diagnostic equipment, biosurveillance and supporting efforts. Efforts included in this project are: (1) Medical Countermeasure Platform Technologies (MCMPT) (2) Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC) (3) Advanced Development and Manufacturing (ADM) facility (4) Countermeasures for Multi-Drug Resistance-Bacterial (CMDR-B) (5) Next Generation Diagnostic System (NGDS) (6) Defense Biological Products Assurance Program (DBPAP) (7) Antiviral Therapeutic Program (AV TX) (8) Botulinum Vaccine (VAC BOT) (9) Antiviral Prophylaxis Studies (Congressional Interest Item) (10) Next Generation Anthrax Vaccine (VAC NGA) (11) Plague Vaccine (VAC PLG) (12) Special Immunizations Program (VAC SIP) The MCMPT will leverage platform technologies to streamline and accelerate the MCM delivery to the Force by reducing developmental risk. 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 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 JMEDICC is a collaboration between United States and Ugandan research and outbreak response entities intended to enable clinical trials for filovirus (Ebola and Marburg) therapeutics during an outbreak. The JMEDICC effort provides a platform of advanced supportive care, scientific rigor, laboratory and logistical capacity, mobility, and rapid response to test new therapeutics or MCM in a filovirus outbreak setting. The JMEDICC effort is a project currently under the Antiviral Therapeutic Program (AV TX) whose resulting capability offers a mechanism to greatly accelerate the development of life-saving products for future outbreaks. The capability building effort at the DoD ADM will establish and enhance proven biopharmaceutical and vaccine manufacturing technologies to accelerate the delivery of medical countermeasures as part of a medical integrated layered defense. The return on investment is an increased level of preparedness and responsiveness to counter current and emerging chemical and biological threats. By establishing and enhancing proven enabling technologies, the DoD ADM will accelerate development of MCMs at all stages of development, enhance preparedness for existing threats, and accelerate response to emerging threats. MCMs impacted by these efforts include: Vaccines for Viral Agents, Vaccines for Bacterial Agents and Toxins, Monoclonal antibodies, antibody fragments, and antibody conjugates for therapeutic and prophylactic use across all agent classes, and Adjuvants. Funds to support the state of readiness were previously provided through individual product development and manufacturing funding lines. In FY20 the Department is providing dedicated funds to support operational availability. The CMDR-B program develops medical countermeasures (MCMs) for Service members for protection against 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 candidate drug was approved by the FDA in Oct 18 for Community Acquired Bacterial Pneumonia (CAPB) that was required as part of the acquisition strategy for the antibiotic repurposing program from S&T to advanced development. The NGDS is a family of systems providing increments of diagnostic capabilities over time that address varied CBR threats across the different echelons of the Combat Health Support System. The mission of the NGDS is to provide 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 improves diagnostic capabilities in deployable and laboratory-based combat health support units. NGDS Inc 1 offers improved operational suitability and affordability over legacy systems by developing FDA cleared biological warfare agent (BWA) and infectious disease IVD assays on an existing commercial diagnostic device with a well established FDA regulatory history and pipeline of commercial non-BWA infectious disease diagnostic tests. 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, by developing lightweight, portable, and simple-to-use instruments and test kits. The 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. This includes advanced platform technologies within the DoD's Advanced Development Manufacturing (ADM) facility. The AV TX will develop and deliver FDA approved antiviral therapeutics for the warfighter. Initial drug product will be developed targeting Ebola Virus Disease. Development of models to test for alphavirus therapeutics are also in work. Other pathogens on the biological warfare threat lists, including viruses of interest from Filoviridae, Arenaviridae, Bunyaviridae, and Flaviviridae, are targets of future interest. 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 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 and Plaguevaccines. 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 SIP conducting research on these diseases.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2020
- Source ID
- MB5_0604384BP_5_0400_PB_2020
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
- Child Accomplishment: 1) MCMPT
- Child Accomplishment: 2) JMEDICC
- Child Accomplishment: 3) DoD ADM Support
- Child Accomplishment: 4) CMDR-B
- Child Accomplishment: 5) NGDS 2
- Child Accomplishment: 6) NGDS 2
- Child Accomplishment: 7) DBPAP
- Child Accomplishment: 8) DBPAP
- Child Accomplishment: 9) AV TX
- Child Accomplishment: 10) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 11) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 12) Cong Mark #230
- Child Accomplishment: 13) VAC NGA
- Child Accomplishment: 14) VAC PLG
- Child Accomplishment: 15) VAC PLG
- Child Accomplishment: 16) VAC SIP
- Child Cost Item: 8c7f1ecf167cab69b6fef08135c6d10e
- Child Cost Item: 302a45541dcbdbfb5bd95b1df01155e1
- Child Cost Item: 653e85039e1f41ec6c3e27b84c21f9f6
- Child Cost Item: 46ec7da3dd12541351a2ada86dab44c4
- Child Cost Item: a1a6d3d30b0cb3902e75ee5e549d4dae
- Child Cost Item: 9f0baee5cd114c4d983b69fc09959a40
- Child Cost Item: be70cc53eac2eb2f7dce38e2a2336c39
- Child Cost Item: 3cfaf9e87dfd501248d79547ac260420
- Child Cost Item: dbeb0ceeecd5eabdb4bedad21c15979d
- Child Cost Item: 99b88e7f6a564672d2a16c4d3900d7c8
- Child Cost Item: 4c12a595911897f00f05a2b8d0012ef1
- Child Cost Item: bfaec7ff6d3b00763e622d2e4e2355be
- Child Cost Item: e9d9a7b2ec1bad67f136b1b78a45658d
- Child Cost Item: e0369e2fd762c4f6246f3b7c4405c7f4
- Child Cost Item: 83a058b923598c9dfac7dc58349e953d
- Child Cost Item: 00e674c4e04407ee461926a63348ec85
- Child Cost Item: d52f1660992cc3e0650021044a0c67db
- Child Cost Item: d76c6d8fb56a38a1b6ed8e231460da2e
- Child Cost Item: eba577cdfdf00f109900a70ccf7099ff
- Child Cost Item: d6c25aa675725e4467af76ae3c3a9d60
- Child Cost Item: 77924330bff63dea6e90cdc3c3e1bc4f
- Child Cost Item: a6e8e06fe94edf2b376a8f887675b22f
- Child Cost Item: edb67ebb21082fdd15ae6514054ca2a5
- Child Cost Item: de472b46930c87148bede45d8a8a975e
- Child Cost Item: f08335421c5d118f44550c35999a0857
- Child Cost Item: a824ddc953193a1a8419035d53b0e077
- Child Cost Item: b9c3809525d672fbda210f0de4bea865
- Child Cost Item: 26af7b2ac83d02f1cde6dabad31e0bd2
- Child Cost Item: d02c176b324cd3661a5c49b886eed880
- Child Cost Item: 5fc11d1bbcc3b5872cb4dcbaba6d70de
- Child Cost Item: 1eb4f61a53060f64a59148f4ecc64d3b
- Child Cost Item: 88049d4a8c912d2723cbf8771c94f56b
- Child Cost Item: 9a5cd3cce24e8d32034ce0159f5cc8f6
- Child Cost Item: 11e28c77fd22565b2ff48771060ad43c
- Child Cost Item: a0c83aaba613d371dc0bf55073b0e02f
- Child Cost Item: 0e782cf691eb3f3dd7d02eab8c0cd515
- Child Cost Item: 90e02cfc60bac09ffa188ce917144f94
- Child Cost Item: c99ea3cdb37bb75dcc2ac83394882a01
- Child Cost Item: ce424cc0c226cdc42a4a85606c5eb1ee
- Child Cost Item: 2e7f9f9a9a9834fe2f366837159b6069
- Child Cost Item: f697a2bf50d6d7c2f09ca60752f1f838
- Child Cost Item: 9895a752775d848cf3449d892e211408
- Child Cost Item: 7ed14be531806853ccf886a0f71db595
- Child Cost Item: 0c2d6b0ab00ccd4a2c6a57c8eb6f87ae
- Child Cost Item: 026278aedf6b35897c5bb14f901a5a6c
- Child Cost Item: f359cd6969e9a74990952c0f896497b6
- Child Cost Item: ba238524932b6d4820e7736e0c3d2460
- Child Cost Item: ed5c77e5768f0329a2e423b3cdde2db5
- Child Cost Item: 3e4270b0eef18ef17c7fdaf896868e6e
- Child Cost Item: 4519eb12a5f11c0c272e6021f5a2b83b
- Child Cost Item: 08ec963b62a16b2dfd4b2da48ad9fd2c
- Child Cost Item: e2ee4fae994b691bced9192fdf0b89bc
- Child Cost Item: b8ba9572f5de3c27d18487fccf9fa3fb
- Child Cost Item: bffe7cc0797ca1bb524c3f35ef9b39a9
- Child Cost Item: 71853ca7a742805b731b738202428c97
- Child Cost Item: f81a0d5b2244078f207d090658c095f8
- Child Cost Item: 25f1ad5fd65d0802447a9fdb32378205
- Child Cost Item: d22849af548d2c65d4d444200e527871
- Child Cost Item: 10c9e1b69f2baa180a88d3696c55e112
- Child Cost Item: 1dc4c780ff1ea7876393efaad3c4dc8e