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. After FY 2022, the Chemical Biological Defense Program (CBDP) RDT&E Projects were restructured to align with the CBDP portfolio construct. MB5 efforts in FY 2022 progress to Projects UN5, PT5, MT5 and EN5. This restructuring provides standardization and alignment across CBDP research, development and acquisition efforts. Efforts included in this Project are: (1) Antiviral Therapeutics Program (AV TX) **Progresses to MT5 in FY2023**, (2) Botulinum Monoclonal Antibodies (BOT MAB) **Progresses to PT5 in FY2023**, (3) Chem Bio Incident Preparedness and Response - Advanced Development and Manufacturing (CBIPR - ADM) **Progresses to EN5 in FY2023**, (4) Countering Emerging Threats Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) **Progresses to MT5 in FY2023**, (5) Defense Biological Products Assurance Program (DBPAP) **Progresses to UN5 in FY2023**, (6) Next Generation Diagnostic System (NGDS) 2 Chemical Diagnostic (NGDS 2 CHEMDX) **Progresses to UN5 in FY2023**, (7) Next Generation Diagnostic System (NGDS) 2 Man Portable Diagnostic System (NGDS 2 MPDS) **Progresses to UN5 in FY2023**, and (8) Special Immunizations Program (VAC SIP) **Progresses to PT5 in FY2023** The Antiviral Therapeutics (AV TX) program will develop and deliver U.S. Food & Drug Administration (FDA) approved antiviral therapeutics for the warfighter. Based on the current gap in defense to the warfighter, the initial therapeutic candidate is now for a treatment against the Marburg virus in lieu of Ebola Zaire to follow for approval of a PanFilo therapeutic. Other pathogens on the biological warfare threat lists, include viruses of interest from Filoviridae, Arenaviridae, Bunyaviridae, and Flaviviridae. Developed broad spectrum antiviral therapeutics will be employed after suspected or confirmed exposure to the relevant threat agents and AV TX Medical Countermeasures (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 Botulinum Monoclonal Antibodies (BOT MAB) program will provide protection from Botulinum neurotoxin (BoNT) which is classified by the Centers for Disease Control and Prevention (CDC)as a category A threat, one that poses the highest risk to the public and national security. This Medical Countermeasure (MCM) will prevent (pre-exposure) and reduce the incidence or progression of botulism disease, following exposure to BoNT serotypes A/B. The drug product contains a total of six monoclonal antibodies, three for BoNT type A and three for BoNT type B, and the planned route of administration is Intra-Muscular (IM) injection. The CBIPR-ADM program ensures prioritization to domestic biopharmaceutical manufacturing capacities, capabilities, and infrastructure (e.g. the DoD-ADM Facility and other strategic partners) that are operationally ready to rapidly develop and manufacture medical countermeasures (MCMs) against current and emerging chemical and biological threats including pandemic response. Prioritization is achieved by establishing and enhancing proven biopharmaceutical manufacturing platform technologies and infrastructure at these facilities. Thus, these facilities will have the capability to accelerate development of MCMs at all stages of development, enhance preparedness for existing threats, and rapidly respond to emerging threats as part of a medical integrated layered defense. MCMs that benefit from these efforts include: Vaccines for Viral Agents, Vaccines for Bacterial Agents and Toxins, monoclonal antibodies, antibody fragments and conjugates for therapeutic and prophylactic use across all agent classes. Funds to support prioritization and operational readiness were previously provided via individual product development and manufacturing funding lines. The Department is now providing dedicated funds. The CBIPR-ADM return on investment is an increased level of preparedness and responsiveness. In FY24, the CBIPR-ADM program continues to establish and enhance new manufacturing platform technologies and infrastructure that will enable the development of MCMs against chemical and biological threats. The Countering Emerging Threats Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) program will develop repurposed drugs as medical countermeasures towards known, potential, and emerging threats, bridging the gap from when a threat is identified until targeted countermeasures such as vaccines are available. CET RAIDR will leverage lessons learned in Coronavirus Aid, Relief, and Economic Security (CARES) Act funded efforts under Coronavirus Disease (COVID) Repurposed Therapeutics (CR TX) to address repurposing of therapeutics. This effort will also use Enhanced Biodefense (ENBD) funding starting in FY23 to evaluate additional drugs candidates for repurposing. The Defense Biological Product Assurance Program (DBPAP) serves as the principal resource of high quality, validated, and standardized biological detection assays and reagents that meet the requirements of the warfighter and Joint biological defense systems. DBPAP pursues an array of analytical tools to verify assay performance and predict effective medical countermeasure solutions that are critical to preparedness. The DBPAP enables an Ordering System for Critical Assays and Reagents (OSCAR), where multiple government agencies and customers can place orders, track order status, and monitor ordering history. In FY24 DBPAP will continue to support optimization and expansion of biological threat agents reference materials and assays to known and emerging threats. The NGDS 2 ChemDx program will provide a rapid, hand-held, point-of-care device, for the quantitative detection of acetyl cholinesterase (AChE) levels in blood samples, an indicator of possible Nerve Agent exposure in individuals. NGDS 2 ChemDx will be employed by the Army, Air Force, Navy, Marines and SOCOM at multiple echelons of healthcare. NGDS 2 ChemDx test results are to be used to aid in the diagnosis and treatment of individuals suspected of having exposure to chemical nerve agents. The NGDS 2 MPDS program will provide a simple-to-use, portable diagnostic device capability that can be used in austere battlefield environments to assist in the diagnosis of infectious diseases and biological warfare agents. The MPDS will enable earlier patient diagnosis, improve decision support for treatment, evacuation and command situational awareness, and mitigate the effects of exposure to unknown infectious disease and biological agents. The SIP continually manages, updates, and executes the Investigational New Drugs (INDs) of selected prophylaxis, treatments and diagnostics development products which provide additional protection to individuals that are at high risk of exposure to CBRN agents. DoD has the mission to maintain 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. In FY23 SIP continues storage of product until destruction. VAC SIP restructures to the Rapid Access to Products in Development (RAPID) program in FY24.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2024
- Source ID
- MB5_0604384BP_5_0400_PB_2024
Related Documents
- Root: Chemical and Biological Defense Program - EMD
- Child Accomplishment: 1) AV TX
- Child Accomplishment: 2) BOT MAB
- Child Accomplishment: 3) BOT MAB
- Child Accomplishment: 4) CBIPR-ADM
- Child Accomplishment: 5) CET RAIDR
- Child Accomplishment: 6) CET RAIDR
- Child Accomplishment: 7) DBPAP
- Child Accomplishment: 8) NGDS 2 CHEMDX
- Child Accomplishment: 9) NGDS 2 CHEMDX
- Child Accomplishment: 10) NGDS 2 MPDS
- Child Accomplishment: 11) NGDS 2 MPDS
- Child Accomplishment: 12) VAC SIP
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