
UNCLASSIFIED
PE 0604384BP: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
UNCLASSIFIED
Chemical and Biological Defense Program Page 147 of 182 R-1 Line #127
Exhibit R-2A, RDT&E Project Justification: PB2023Chemical and Biological Defense Program
Date: April 2022
Appropriation/Budget Activity
0400 / 5
R-1 Program Element (Number/Name)
PE 0604384BP / CHEMICAL/BIOLOGICAL
DEFENSE (EMD)
Project (Number/Name)
MB5 / Medical Biological Defense (SDD)
BoNT serotypes A/B in adults. 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 maintains the DoD-ADM facility in a state of operational readiness so that it can rapidly develop and manufacture medical countermeasures
(MCMs) against current and emerging chemical and biological threats including pandemic response. Operational readiness is achieved by establishing and enhancing
proven biopharmaceutical manufacturing platform technologies and infrastructure at the facility. By establishing and enhancing proven manufacturing platform
technologies and infrastructure, the DoD-ADM facility 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 impacted by 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 the facility in a state of 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.
The NGDS 2 ChemDx program will provide a rapid, hand-held, point-of-care device, for the quantitative detection of acetyl cholinesterase (AChE) activity in finger stick
and venous whole blood samples of individuals suspected of being exposed to cholinesterase inhibiting substances, such as chemical nerve agents. 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. In FY23, NGDS 2 MPDS concludes
hardware, software and assay design; completes clinical trials for the device and two assay panels, and; continues development of a third assay panel.
The DBPAP program facilitates new technology transition to advanced development, efficient production, and timely distribution. DBPAP consists of a Critical Assays
and Reagents, which serves as the principal resource for biological assays and reagents, and the Targeted Acquisition of Reference Materials Augmenting Capabilities
(TARMAC), which generates data on biodefense pathogens to inform product development. DBPAP 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 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. In FY23 DBPAP continues development/expansion of biological threat
agents reference materials to known and emerging threats.
The AV TX program will develop and deliver 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, including viruses of interest from Filoviridae, Arenaviridae, Bunyaviridae, and Flaviviridae, are targets of future interest. Developed broad
spectrum antiviral therapeutics will be employed after suspected or confirmed exposure to the relevant threat agents and AVTX Medical Countermeasures (MCMs)
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