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. In FY2023, the Chemical Biological Defense Program (CBDP) RDT&E Projects have been restructured to align to the CBDP portfolio. MB4 efforts in FY2022 progress to the Enabling Investments (EN) and Protect (PT) portfolio. This restructuring is intended to provide standardization and alignment across CBDP research, development and acquisition efforts. Efforts included in this Project are: (1) COVID Therapies Monoclonal Antibodies (COVID TX MAB) **Progresses to PT4 in FY2023**, (2) Validated Nucleic Acid Vaccine Construction (COVID VAC) **Progresses to PT4 in FY2023**, (3) Biosafety Level 4 Good Laboratory Practice Test and Evaluation (BSL4 GLP T&E), (4) Chem Bio Incident Preparedness and Response - Biosafety Level 4 Research Institute of Infectious Diseases (CBIPR - BSL4 RIID), (5) Chem Bio Incident Preparedness and Response - Advanced Development and Manufacturing (CBIPR - ADM) **Progresses to EN4 in FY2023**, (6) Medical Countermeasure Platform Technologies (MCMPT) **Progresses to PT4 in FY2023**, and (7) Next Generation Diagnostic System 2 Chemical Diagnostics (NGDS 2 CHEMDX) The COVID TX MAB program will leverage lessons learned from the COVID response to rapidly discover, manufacture and clinically evaluate new monoclonal antibodies to deliver short term capabilities against long standing biological threats. Monoclonal antibodies are a proven technology and first line of defense for many biological threats. In FY22, COVID TX MAB will target the discovery, identification and small scale manufacture of mAbs, with sufficient material to support non-clinical and clinical testing. COVID VAC will leverage lessons learned from the COVID response to shorten future emergency response timelines and creating interim capabilities for prophylaxis. In FY2022, COVID VAC will work with the interagency, industry, and academia to design and construct vaccine prototypes on validated nucleic acid vaccine platforms then evaluate them in appropriate animal models through Phase 1 clinical trials for safety as needed. The BSL4 GLP T&E program performs T&E and provides the essential data packages to support US Food and Drug Administration (FDA) approval of leading biodefense medical countermeasure candidates to protect the Warfighter and the Nation. This capability provides dedicated capacity at U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) for Department of Defense (DoD) to conduct biosafety level "4" studies that produce Good Laboratory Practices (GLP) study reports required by the FDA. The CBIPR - BSL4 RIID program continues to utilize and maintain a testing capability at the existing and planned new USAMRIID facilities supporting testing of Medical Countermeasures (MCM) against threats that require high-level containment using non-human primates. 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. In FY22, the CBIPR-ADM program continues to establish and enhance new manufacturing platform technologies that will enable the development of MCMs against chemical and biological threats. The MCMPT program intends to streamline and accelerate medical countermeasure delivery to the Warfighter by reducing developmental risk using well known platform technologies. MCMPT is establishing enabling technologies and prepositioning platform systems within the DoD's Advanced Development Manufacturing (ADM) network using standardized discovery, design, manufacturing, and testing processes to reduce the medical countermeasure (MCM) development risks. MCMPT will deliver an enduring capability from which future candidates can be manufactured. In FY23 the MCMPT program continues development of a rapid response capability. The NGDS 2 ChemDx program will provide a rapid, hand-held, point-of-care device. It utilizes an electrochemical assay for the quantitative detection of acetylcholinesterase (AChE) activity in finger stick and venous whole blood samples of individuals suspected of being exposed to cholinesterase inhibiting substances, such as nerve agents. NGDS 2 ChemDx diagnostic capabilities will be employed in Army, Air Force, Navy, Marines and United States Special Operations Command (SOCOM) (Roles 1-3), with applicability to routine healthcare at higher echelons. NGDS 2 ChemDx test results are to be used to aid in the diagnosis of cholinesterase inhibition in an individual suspected of having exposure to non-traditional agents (NTAs) and his/her treatment decision with an Antidote Treatment Nerve Agent, Autoinjector (ATNAA): self-aid; buddy aid; combat lifesaver; or medic. In FY22 NGDS 2 ChemDx continues Engineering & Manufacturing Development.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2023
- Source ID
- MB4_0603884BP_4_0400_PB_2023
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (ACD&P)
- Child Accomplishment: 1) COVID TX MAB
- Child Accomplishment: 2) COVID VAC
- Child Accomplishment: 3) BSL-4 GLP Test & Evaluation
- Child Accomplishment: 4) CBIPR-BSL4 RIID
- Child Accomplishment: 5) CBIPR - ADM
- Child Accomplishment: 6) Medical Countermeasure Platform Technologies (MCMPT)
- Child Accomplishment: 7) MCMPT
- Child Accomplishment: 8) NGDS 2 Chemical Diagnostics (NGDS 2 CHEMDX)
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