MEDICAL BIOLOGICAL DEFENSE (ACD&P)
Abstract
This project includes Medical Countermeasure platform technologies, Medical Countermeasures (vaccines and therapeutics), development of reagents, assays, diagnostic equipment, biosurveillance and supporting efforts. Efforts included in this project are: (1) Medical Countermeasure Platform Technologies (MCMPT) (2) Advanced Development and Manufacturing (ADM) facility (3) Biosafety Level 4 Good Laboratory Practice Test and Evaluation (BSL4 GLP T&E) (4) Countermeasures for Multi-Drug Resistance-Bacterial (CMDR-B) (5) Next Generation Diagnostic System (NGDS) (6) Antiviral Therapeutic (AV TX) (7) Filovirus Vaccine (VAC FILO) (8) Ricin vaccine (VAC RIC) (9) Venezuelan Equine Encephalitis (VAC VEE) (10) Western, Eastern, and Venezuelan Equine Encephalitis (VAC WEVEE) Vaccine The goal of the MCMPT is to counter a variety of threat agents using standardized discovery, design, manufacturing, and testing processes to reduce the medical countermeasure (MCM) development risks. Efforts will center on leveraging the DoD's Advanced Development Manufacturing (ADM) facility and developing robust manufacturing processes. 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 a thirty-six month Advanced Technology Demonstration (ATD) is the Advanced Development and Manufacturing Antibody Technologies (ADAMANT). This platform provides an enduring capability from which future candidates can be manufactured. 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 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 Medical Countermeasure BSL-4 GLP 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) GLP T&E studies to meet programmatic needs following all applicable regulatory, biosurety, and safety standards. The CMDR-B program develops 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 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 chemical, biological and radiological (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 Increment 1 offers improved operational suitability and affordability over legacy systems by developing FDA cleared biological warfare agent (BWA) and infectious disease in vitro diagnostic (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 AV TX Program is continuing the development of a Ebola Zaire therapeutic treatment drug that is on the regulatory path for FDA approval as an antiviral therapeutic for the warfighter. AV TX is continuing the development of models to test for alphavirus therapeutics that include several Natural History Studies required per FDA and animal rule regulatory requirements. Other pathogens on the biological warfare threat list, including viruses of interest from Filoviridae, Arenaviridae, Bunyaviridae, and Flaviviridae, are targets of future development efforts. 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 VAC FILO Program develops vaccines that will offer protection against the threat of Ebola and Marburg viruses. The program office is prioritizing the development and delivery of a licensed Marburg vaccine while working with Science & Technology to further develop Ebola vaccine candidates to meet the DoD requirement. The current budget supports development of a single Marburg prototype to protect against the BW threat through TMRR phase. The DoD anticipates that the FDA will approve a vaccine using the Animal Rule, which allows for the demonstration of efficacy in a relevant animal model(s). The VAC RIC program supports one DoD vaccine candidate including manufacturing GMP lots; and the continuation of animal model and assay development studies. The Ricin toxin is a validated bioweapon threat that is lethal, available and easily produced. The VAC RIC Program concluded development activities and transferred the technology to the ADMc in FY18. The VAC WEVEE Vaccine will protect the Warfighter against aerosolized exposure to three strains of alphaviruses; Western, Eastern and Venezuelan equine encephalitis viruses. Services have prioritized the development and delivery of an FDA-licensed Venezuelan Equine Encephalitis Virus (VEEV) vaccine. In FY19 the VAC WEVEE program shifted to the VAC VEE program. The VAC VEE program uses a parallel evaluation of Modified Vaccinia Ankara (MVA) and Virus Like Particle (VLP) vaccine prototypes through Phase I clinical trials to achieve competitive prototyping in the Technology Maturation & Risk Reduction phase. Several potential decision points will be used to assess the prototypes at competitive selection. The schedule is based on a competitive selection to one prototype. The Government will serve as the integrator during this phase by managing and coordinating the various vaccine development efforts. At MS B, the best prototype will be selected through a full and open competition to transition to the Engineering and Manufacturing Development (EMD) phase, with delivery of a FDA-licensed WEVEE vaccine. The development efforts will be a Cost Plus and Firm Fixed Price CLINs. Additionally, the Program Office will partner with Health and Human Services/National Institute of Allergies and Infectious Diseases (HHS/NIAID), DoD agencies, and laboratories to include U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). This DoD program is the Public Health Emergency Medical Countermeasures lead for the advanced development of this vaccine and is leveraging expertise across the Federal and International sectors to ensure programmatic success.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2020
- Source ID
- MB4_0603884BP_4_0400_PB_2020
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