R01AI190528

FEND-TB - AMONG THE ESTIMATED 10 MILLION PEOPLE WITH TUBERCULOSIS (TB) IN 2022, OVER 3 MILLION WERE NOT DIAGNOSED, UNDERSCORING THE NEED FOR NEW TOOLS AND DIAGNOSTIC STRATEGIES TO IMPROVE TB CASE DETECTION, INCLUDING IN DIFFICULT TO-DIAGNOSE POPULATIONS SUCH AS CHILDREN AND PEOPLE WITH EXTRAPULMONARY OR EARLY/SUBCLINICAL TB. AN EQUALLY URGENT NEED IS FOR DRUG SUSCEPTIBILITY TESTS (DST) THAT CAN RAPIDLY IDENTIFY TB DRUG RESISTANCE/SUSCEPTIBILITY, INCLUDING TO NEW DRUGS, TO CURE EACH PERSON WITH TB AND TO PROTECT THE EFFICACY OF NEWER DRUGS FOR THOSE WHO MAY BENEFIT FROM THEM IN THE FUTURE. PARTIALLY FUELED BY INNOVATIVE PLATFORMS DEVELOPED TO ADDRESS THE COVID-19 EPIDEMIC, THE LAST DECADE HAS SEEN A SURGE OF NEW TB DIAGNOSTIC PLATFORMS AND ASSAYS. THESE NEW TESTS, SOMETIMES DEVELOPED BY SMALL COMPANIES WITH LIMITED RESOURCES AND LITTLE OR NO EXPERIENCE WORKING WITH MYCOBACTERIUM TUBERCULOSIS (MTB) AND CLINICAL TB, REQUIRE RIGOROUS AND UNBIASED EVALUATIONS. FURTHERMORE, MANY DIAGNOSTIC DEVELOPERS DO NOT SUFFICIENTLY APPRECIATE THE CHALLENGES PRESENTED BY SAMPLE PROCESSING, THE (OFTEN) NEED FOR HIGH TEST SENSITIVITY, OR THE ACCEPTABLE TRADEOFFS BETWEEN SENSITIVITY/SPECIFIC VERSUS ASSAY COSTS, EASE OF USE AND RELEVANT TARGET POPULATIONS OR TB DISEASE STATES. THUS, THE UNMET NEEDS OF TB DIAGNOSTIC DEVELOPERS ARE SPECIFIC TO THE TYPE OF MANUFACTURER, DIAGNOSTIC TECHNOLOGY, ASSAY FORMAT, AND INTENDED USE. OUR PROPOSAL BRINGS TOGETHER A CONSORTIUM OF EXPERIENCED INVESTIGATORS AND A GLOBAL NETWORK OF CLINICAL RESEARCH SITES TO SUPPORT TB DIAGNOSTIC EVALUATIONS THROUGH A FAST-PACED AND FLEXIBLE PIPELINE THAT INCLUDES TECH SCOUTING, DEVELOPMENT MENTORING, AND CLINICAL TESTING OF EARLY-STAGE TB DIAGNOSTICS. WITH THE INCLUSION OF AN ANALYTIC LABORATORY CORE THAT CAN ASSESS AND HELP OPTIMIZE NEW TECHNOLOGIES PRIOR TO AND AFTER CLINICAL STUDIES OUR PROGRAM OFFERS A UNIQUE OPPORTUNITY TO ACCELERATE PROMISING TB DIAGNOSTICS THROUGH THEIR OPTIMAL DEVELOPMENT PIPELINE. CONSORTIUM MEMBERS HAVE ALMOST THREE DECADES OF LEADERSHIP EXPERIENCE IN DIAGNOSTIC TECH SCOUTING, RESEARCH, DEVELOPMENT, CLINICAL TRIALING, AND IMPLEMENTATION ACTIVITIES. FIELDING A BALANCE OF ESTABLISHED PLATFORMS, FAST FOLLOWERS, AND CUTTING- EDGE TECHNOLOGIES, WE WILL PERFORM THE FOLLOWING SPECIFIC AIMS: 1) IDENTIFY PROMISING EARLY-STAGE DIAGNOSTICS FOR EVALUATION AND DEVELOP FOR EACH A STEPWISE EVALUATION PLAN; 2) EVALUATE THE DIAGNOSTIC ACCURACY OF NOVEL RAPID POINT OF CARE/NEAR CARE TB DIAGNOSTICS AND DETERMINE THE IMPACT OF RELEVANT PATIENT CHARACTERISTICS ON TEST ACCURACY; AND 3) PROVIDE FEEDBACK TO DIAGNOSTIC DEVELOPERS, POLICYMAKERS, AND OTHER STAKEHOLDERS ON PERFORMANCE AND USABILITY OF NOVEL DIAGNOSTIC TESTS AND POTENTIAL STRATEGIES FOR USE IN TB ENDEMIC SETTINGS.

Rutgers The State University Of New Jersey

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]

New Jersey United States

State-Wide

Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) (R01 Clinical Trial Not Allowed) (RFA-AI-24-010)

Amendment Since initial award the total obligations have increased 19% from $2,593,818 to $3,089,360.