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. Efforts included in this project are: (1) COVID Therapies Monoclonal Antibodies (COVID TX MAB) (2) COVID Vaccine Validated Nucleic Acid Vaccine Construction (COVID VAC) (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) (6) Medical Countermeasure Platform Technologies (MCMPT) (7) Next Generation Diagnostic System 2 (NGDS Increment 2) (8) NGDS 2 Chemical Diagnostics (NGDS 2 CHEMDX) (9) Filovirus Vaccine (VAC FILO) (10) Venezuelan Equine Encephalitis (VAC VEE) 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. The COVID VAC Validated Nucleic Acid Vaccine Construction program will leverage lessons learned from the COVID response to shorten future emergency response timelines and create interim capabilities for prophylaxis. In FY22, COVID VAC will work with 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 is the capability building effort at the DoD ADM to establish and enhance proven biopharmaceutical and vaccine manufacturing technologies and accelerate the delivery of medical countermeasures as part of a medical integrated layered defense. The CBIPR-ADM 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 medical countermeasures (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 Department is providing dedicated funds to support operational availability. In FY22, CBIPR-ADM continues tech transfer and enhancement of manufacturing technologies to support MCM development against biological threats. The MCMPT program intends to streamline and accelerate medical countermeasure delivery to the Warfighter by reducing developmental risk using the CBDP's strategic framework, the Agile Medical Paradigm. MCMPT is establishing enabling technologies and prepositioning 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. 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. In FY22 the MCMPT program continues development of a rapid response capability. The NGDS is a family of systems providing increments of diagnostic capabilities over time that address varied chemical, biological and radiological (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 2 will complement NGDS Increment 1 by developing diagnostics for unmet biological pathogen and toxin threats, chemical and radiological exposures, and provide capability to lower echelons of care. NGDS Increment 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 Increment 2 transitions into two programs of record; NGDS 2 Man Portable Diagnostic System (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 against chemical threat agents to end-users in non-laboratory, far-forward environments. The VAC FILO Program develops vaccines that will offer protection against the threat of Ebola and Marburg viruses. The program office is prioritizing the development and delivery of a licensed Marburg vaccine while working with Science & Technology (S&T) to further develop Ebola vaccine candidates to meet the DoD requirement. The current budget supports responsible closeout of program development efforts. The DoD anticipates that the FDA will approve a vaccine using the Animal Rule, which allows for the demonstration of efficacy in a relevant animal model(s). Program continuing to conduct market research to identify viable candidates for transition in the out years. The VAC VEE Program develops a vaccine that will protect the Warfighter against aerosolized exposure to the alphavirus Venezuelan equine encephalitis. Additionally, the Program Office will partner with Health and Human Services/National Institute of Allergies and Infectious Diseases (HHS/NIAID), DoD agencies, and laboratories. This DoD program is the Public Health Emergency Medical Countermeasures lead for the advanced development of this vaccine and is leveraging expertise across the Federal and International sectors to ensure programmatic success. FY20 budget supports responsible closeout of program.

Document Details

• Document Type: Project
• Publication Date: Oct 01, 2022
• Source ID: MB4_0603884BP_4_0400_PB_2022

Tags

Readers

• Critical Infrastructure Protection in CBRN and WMD Threats.

Technology Areas

• Biotechnology