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. After FY 2022, the Chemical Biological Defense Program (CBDP) RDT&E Projects were restructured to align with the CBDP portfolio construct. MB4 efforts in FY 2022 progress to Projects EN4 and PT4. This restructuring provides 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) Chem Bio Incident Preparedness and Response - Advanced Development and Manufacturing (CBIPR - ADM) **Progresses to EN4 in FY2023**, and (4) Medical Countermeasure Platform Technologies (MCMPT) **Progresses to PT4 in FY2023** 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 monoclonal antibodies (mAbs), with sufficient material to support non-clinical and clinical testing. In FY23 COVID TX MAB transitions to the Accelerated Antibodies-Enhanced Biodefense (AA-ENBD) program. COVID VAC will leverage lessons learned from the Coronavirus Disease 2019 (COVID-19) response to shorten future emergency response timelines, mitigate impacts of biological threat outbreaks, and create interim capabilities to protect the warfighter. In FY 2022, COVID VAC will leverage interagency, industry, and academia partnerships to develop nucleic acid vaccines. COVID VAC will transition to Vaccine Acceleration by Modular Progression (VAMP) in FY 2023 where VAMP will continue to build the Warfighter's bio-armor to protect against biological threats. In addition to nucleic acid vaccines, VAMP will develop alternative vaccine platform technologies and manage awards utilizing go/no-go checkpoints along the development pathway. 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 MCMPT program streamlines and accelerates delivery of medical countermeasure to the Warfighter against known and emerging biological threats by establishing mature platform technologies that allow for rapid response and by reducing developmental risks. MCMPT is establishing enabling technologies and prepositioning platform systems within the Department of Defense (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.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2024
- Source ID
- MB4_0603884BP_4_0400_PB_2024
Related Documents
- Root: Chemical and Biological Defense Program - Dem/Val
- Child Accomplishment: 1) COVID TX MAB
- Child Accomplishment: 2) COVID VAC
- Child Accomplishment: 3) CBIPR-ADM
- Child Accomplishment: 4) MCMPT
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