UC7AI180261

Positioning Mason's Regional Biocontainment Laboratory for Effective Pandemic Preparedness - Overall Core Abstract

George Mason University (GMU) Biomedical Laboratory (BRL) is one of 12 Regional Biocontainment Laboratories (RBLS) established through NIAID support in the early 2000s to serve as Biosafety Level 3 (BSL-3) facilities to conduct cutting-edge pathogen research and serve as resources to rapidly address emerging infectious disease outbreaks.

The BRL serves as a center for scientific collaboration to 1) generate advanced knowledge of pathogen biology and host interaction mechanisms, and 2) evaluate diagnostics, therapeutics, and vaccines.

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic exposed critical vulnerabilities to the nation's BSL-3 research infrastructure, including the GMU BRL facility. GMU learned that there are gaps and opportunities to enhance safe BRL operations management to more effectively face sudden disease outbreaks and support a more robust pipeline of innovations for response to future pandemics.

This proposal outlines activities for three cores to enhance the BRL facility, increase high containment training, and provide additional BSL-3 research services for pre-clinical innovation. The GMU RBL will 1) implement a comprehensive BSL-3 facilities preventative maintenance and upgrade plan to ensure continuity of operations, compliance with federal regulations, and a safe and secure facility; 2) enhance safety and quality of BSL-3 laboratory practices; and 3) create two new research cores in high containment.

The expanded Microphysiological Systems (MPS) Core will enable organ-on-a-chip (OOC) and organoid models for lead optimization, safety assessment, off-target effects, toxicity, and efficacy analysis. The Advanced Animal Research (AAR) Core will support pre-clinical studies starting with in vivo exposures and countermeasure testing and transitioning to advanced animal imaging, spatial tissue, and cellular analysis.

Together, the cores will accelerate vaccine and therapeutic drug discovery and improve understanding of the transmission and pathogenesis of infectious agents as well as host response.

George Mason University

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Manassas, Virginia 201102201 United States

Single Zip Code

Limited Competition: Resources and Workforce Development for the Regional Biocontainment Laboratories (UC7 Clinical Trial Not Allowed) (RFA-AI-22-075)

Amendment Since initial award the total obligations have increased 202% from $2,495,244 to $7,525,547.