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Research Project: Research, Development, Testing, and Technical Services to Advance the Technology Transfer of Veterinary Medical Countermeasures at the NBAF

Location: Biologics Development Module

2023 Annual Report


Objectives
Objective 1. Advance the development of veterinary medical countermeasures to detect, prevent, control, and respond to Foot-and-Mouth Disease (FMD) incursions. Objective 2. Advance the development of veterinary medical countermeasures to detect, prevent, control, and respond to African Swine Fever (ASF) incursions. Objective 3. Advance the development of veterinary medical countermeasures to detect, prevent, control, and respond to Vesicular Stomatitis Virus (VSV) incursions. Objective 4. Advance the development of veterinary medical countermeasures to detect, prevent, control, and respond to Japanese Encephalitis Virus (JEV) incursions. Objective 5. Advance the development of veterinary medical countermeasures to detect, prevent, control, and respond to Rift Valley Fever (RVF) incursions. Objective 6. Advance the development of veterinary medical countermeasures to detect, prevent, control, and respond to Henipaviral incursions. Objective 7. Advance the development of veterinary medical countermeasures to detect, prevent, control, and respond to Crimean-Congo Hemorrhagic Fever Virus (CCHF) incursions. Objective 8. Advance the development of veterinary medical countermeasures to detect, prevent, control, and respond to new emerging diseases of high consequence to the U.S economy and public health.


Approach
The mission of the BDM is to provide research, development, testing and evaluation (RDT&E), and technical services necessary to advance through the early development stage, veterinary medical countermeasures (MCM) for a broad array of animal and public health threats. The BDM program at NBAF plays a critical role in bridging the gap to decrease risk for private sector investments in agro- and biodefense MCM development. Mitigating the risk for private sector investments in MCM development for foreign animal diseases is paramount since there is no commercial market for diseases that technically, do not exist in the United States, but pose a significant threat to animal agriculture and public health. Importantly, the BDM directly supports APHIS’s roles and responsibilities related to veterinary public health and food defense associated with emerging and zoonotic high consequence pathogens.


Progress Report
The Biologics Development Module (BDM) is getting ready to begin the Phase 0 Science Transition within the National Bio and Agro-Defense Facility (NBAF) in Manhattan, Kansas, where staff will be using Biologic Security Level-1 (BSL-1) cell lines and non-infectious organisms to test the procedures and mechanical systems within NBAF. Despite some minor facility modifications that still need to be made to support the new equipment, it is expected the BDM will be ready for the Phase 1 Science transition. Additional staff were added this year, and the BDM has begun putting workflows and processes into place. The BDM has several research agreements that have been submitted for approval.


Accomplishments

4. Biologics Development Module stakeholder meeting. Biologics Development Module stakeholder meeting. The Biologics Development Module Stakeholder Meeting was conducted by the National Bio and Agro-Defense Facility in Manhattan, Kansas, on June 21st-22nd, 2023. The meeting brought together Biologics Development Module staff, National Bio and Agro-Defense Facility scientists and leadership, along with stakeholders from large and small veterinary biologics manufacturers, diagnostic companies, regulatory authorities, academic institutions, government agencies, and others to learn more about the Biologics Development Module and its functions and capabilities. The feedback we received was overwhelmingly positive, and new research agreements for the Biologics Development Module and other National Bio and Agro-Defense Facility science units will be one of the outcomes of the meeting.