Medical Biological Defense (SDD)
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) Botulinum Monoclonal Antibodies (BOT MAB) (2) Chem Bio Incident Preparedness and Response - Advanced Development and Manufacturing (CBIPR - ADM) (3) Countermeasures for Multi-Drug Resistance-Bacterial (CMDR-B) (4) Medical Countermeasure Platform Technologies (MCMPT) (5) Next Generation Diagnostic System 2 (NGDS 2) (6) NGDS 2 Chemical Diagnostic (NGDS 2 CHEMDX) (7) NGDS 2 Man Portable Diagnostic System (NGDS 2 MPDS) (8) Defense Biological Products Assurance Program (DBPAP) (9) Antiviral Therapeutics Program (AV TX) (10) Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC) (11) Botulinum Vaccine (VAC BOT) (12) Antiviral Prophylaxis Studies (Congressional Interest Item) (13) Plague Vaccine (VAC PLG) (14) Special Immunizations Program (VAC SIP) Initiated by the Medical Countermeasure Platform Technologies (MCMPT), the goal of Botulinum Monoclonal Antibodies (BOT MAB) advanced development effort is to counter exposure to BOT A & B toxins. This capability is complementary to botulinum vaccine and therapeutics and will provide a continuum of protection against botulinum toxins. BoNT Advanced Development and Manufacturing of Antibody Technology (ADAMANT) leverages the advanced platform technology developed within the DoD's Advanced Development Manufacturing (ADM) facility. Efforts will focus on the evaluation of efficacy in pivotal animal studies to satisfy Food and Drug Administration (FDA) requirements for the animal rule, as well as the preparation for and execution of consistency lots to support phase 2/3 clinical trials. A Biologics License Application (BLA) will be submitted to the FDA including all clinical, non-clinical and manufacturing data. The FDA grants licensure to products that are determined to be safe and efficacious. 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. 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 (CABP) that was required as part of the acquisition strategy for the antibiotic repurposing program from S&T to advanced development. MCMPT is establishing enabling technologies and pre positioning platform systems at the DoD's Advanced Development Manufacturing (ADM) facility using standardized discovery, design, manufacturing, and testing processes to reduce the medical countermeasure (MCM) development risks. Efforts will center on leveraging the ADM's 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. Through the Advanced Development and Manufacturing Antibody Technologies (ADAMANT) and Rapid Response platforms, MCMPT will deliver an enduring capability from which future candidates can be manufactured. 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 technology (MCMPT) capability. 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 Increment 1 offers improved operational suitability and affordability over legacy systems by developing FDA cleared 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. In FY21, NGDS 2 has been broken out into two separate programs; NGDS 2 MPDS Program and NGDS 2 CHEMDX Program. NGDS 2 MPDS will complement NGDS Increment 1 by providing a lightweight, portable, and simple-to-use diagnostic capability to end-users in non-laboratory, far-forward environments. NGDS 2 CHEMDX will provide a lightweight, portable, and simple-to-use diagnostic capability to end-users in non-laboratory, far-forward environments. 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 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 with Marburg and Sudan to follow for approval of a PanFilo therapeutic to the warfighter. Development of models to provide a therapeutic for alphavirus are being developed through JSTO Research & Development. 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 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 whose resulting capability offers a mechanism to greatly accelerate the development of life-saving products for future outbreaks. The performer received approval of an emergency access protocol for the use of the Remdesivir drug in the country of Uganda. JMEDICC effort was funded by the AV TX Program in FY19. 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 Plague 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 BLA to the 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 Recombinant Botulinum A/B and Plague vaccine programs are no longer seeking FDA licensure. IND vaccines will be used to provide additional levels of protection to laboratory workers in the SIP conducting research on these diseases. DoD has the mission to maintain Investigational New Drug (IND) vaccines in Good Manufacturing Practice (GMP) storage and to conduct the periodic potency and stability testing of these materials to support submissions to the FDA.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2021
- Source ID
- MB5_0604384BP_5_0400_PB_2021
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
- Child Accomplishment: 1) Botulinum Monoclonal Antibodies (BOT MAB)
- Child Accomplishment: 2) Chem Bio Incident Preparedness and Response - Adv Dev Mfg (CBIPR - ADM)
- Child Accomplishment: 3) Countermeasures for Multi-Drug Resistance-Bacterial (CMDR-B)
- Child Accomplishment: 4) Medical Countermeasure Platform Technologies (MCMPT)
- Child Accomplishment: 5) Next Generation Diagnostic System 2 (NGDS 2)
- Child Accomplishment: 6) NGDS 2
- Child Accomplishment: 7) NGDS 2 Chemical Diagnostic (NGDS 2 CHEMDX)
- Child Accomplishment: 8) NGDS 2 Man Portable Diagnostic System (NGDS 2 MPDS)
- Child Accomplishment: 9) NGDS 2 MPDS
- Child Accomplishment: 10) Defense Biological Products Assurance Program (DBPAP)
- Child Accomplishment: 11) Antiviral Therapeutics Program (AV TX)
- Child Accomplishment: 12) AV TX - JMEDICC
- Child Accomplishment: 13) Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC)
- Child Accomplishment: 14) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 15) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 16) Cong #230
- Child Accomplishment: 17) VAC PLG
- Child Accomplishment: 18) VAC PLG
- Child Accomplishment: 19) VAC SIP
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