R01AI190419

RAPID RESEARCH FOR DIAGNOSTICS DEVELOPMENT IN TB NETWORK: EPISODE 2 (R2D2 TB NETWORK II) - PROJECT SUMMARY IN HIGH BURDEN COUNTRIES, MANY PATIENTS WITH TUBERCULOSIS (TB) ARE NEVER DIAGNOSED OR TREATED WITH EFFECTIVE DRUG REGIMENS, LEADING TO ONGOING TRANSMISSION AND INCREASED MORTALITY. A PRIMARY REASON IS THAT CURRENT TB DIAGNOSTICS ARE INADEQUATE WITH KEY ISSUES INCLUDING INADEQUATE SENSITIVITY, HIGH COSTS, INABILITY TO BE USED AT LOWER LEVELS OF THE HEALTH SYSTEM AND/OR FAILURE TO IDENTIFY DRUG RESISTANCE. NO SINGLE TEST IS LIKELY TO ADDRESS ALL THESE LIMITATIONS AND THEREFORE THE WORLD HEALTH ORGANIZATION (WHO) HAS DESCRIBED OPTIMAL TEST CHARACTERISTICS FOR DIFFERENT USE-CASES IN THE FORM OF TARGET PRODUCT PROFILES (TPPS). TO ADVANCE NOVEL SOLUTIONS FOR HIGH PRIORITY TPPS, IDENTIFYING PROMISING TECHNOLOGIES AND LINKING THEIR DEVELOPERS TO EXPERIENCED CLINICAL STUDY SITES TO FACILITATE EVALUATION AND PERFORMANCE FEEDBACK IS ESSENTIAL. THE OVERALL GOAL OF THE RAPID RESEARCH IN DIAGNOSTICS DEVELOPMENT FOR TB NETWORK: EPISODE 2 (R2D2 TB NETWORK II) IS TO ADDRESS THE CRITICAL UNMET NEED FOR BETTER TB DIAGNOSTICS IN ORDER TO CLOSE THE “DIAGNOSTIC GAP” AND THEREBY IMPROVE PATIENT AND PUBLIC HEALTH OUTCOMES. TO ACHIEVE THIS GOAL, THE R2D2 TB NETWORK II WILL SOLICIT, REVIEW AND PRIORITIZE THE MOST RELEVANT NOVEL TB DIAGNOSTICS ACROSS DIFFERENT PHASES OF DEVELOPMENT AND ACROSS DIFFERENT USE CASES FOR EVALUATION DURING THE AWARD PERIOD (OBJECTIVE 1). WE WILL LEVERAGE OUR EXPERIENCED TECHNOLOGY TEAM, OUR PARTNERSHIP WITH A BIOTECH INCUBATOR TO BRING IN TECHNOLOGY INNOVATORS NOT ALREADY WORKING IN THE TB FIELD AND OUR PARTNERSHIP WITH KEY STAKEHOLDERS WITH CONNECTIONS TO TB DIAGNOSTICS DEVELOPERS. ANALYTICAL AS WELL AS CLINICAL STUDIES TO ASSESS ACCURACY, USABILITY, ACCEPTABILITY AND FEASIBILITY OF EARLIER PHASE TESTS WILL ALLOW FOR ITERATIVE TEST OPTIMIZATION (OBJECTIVE 2). THESE STUDIES WILL BE NESTED, WHERE POSSIBLE, WITHIN LARGE-SCALE, MULTI-CENTER ASSESSMENTS OF DESIGN-LOCKED DIAGNOSTICS TO FACILITATE WHO POLICY REVIEW (OBJECTIVE 3). THE CLINICAL STUDIES WILL RIGOROUSLY FOLLOW WHO GUIDANCE FOR SPECIFIC USE-CASES AS WELL AS GENERAL GUIDELINES FOR HIGH-QUALITY DIAGNOSTIC EVALUATIONS. FOR DESIGN-LOCKED DIAGNOSTICS, WE WILL COMPLEMENT THE CLINICAL STUDIES WITH ASSESSMENTS OF INCREMENTAL VALUE (INCLUDING WHEN COMBINED WITH OTHER TESTS) THROUGH HEALTH ECONOMIC AND TRANSMISSION MODELING STUDIES (OBJECTIVE 4) TO FURTHER SUPPORT WHO- AND COUNTRY-LEVEL POLICY REVIEWS. TO ACCOMPLISH THESE OBJECTIVES, THE R2D2 TB NETWORK II BRINGS TOGETHER INVESTIGATORS WITH A BROAD RANGE OF RELEVANT EXPERTISE RELATED TO TB DIAGNOSTIC RESEARCH AND 10 EXPERIENCED CLINICAL STUDY SITES IN 9 HIGH-BURDEN COUNTRIES THAT PROVIDE ACCESS TO RELEVANT POPULATIONS FOR EVALUATING TB DIAGNOSTICS. THE PIS OVERSEEING THE NETWORK HAVE DEEP EXPERTISE IN COORDINATION OF MULTI-CENTER STUDIES, A DEMONSTRATED HISTORY OF WORKING WITH A BROAD RANGE OF PRODUCT DEVELOPERS, EXPERIENCE IN THE REVIEW AND ENDORSEMENT PRACTICES OF THE WHO AND REGULATORY AUTHORITIES, AND MORE THAN A DECADE OF COLLABORATIVE LEADERSHIP EXPERIENCE. BY FOSTERING AND SUPPORTING A STRONG, COLLABORATIVE NETWORK OF INVESTIGATORS, PRODUCT DEVELOPERS AND STAKEHOLDERS ACROSS DIVERSE GEOGRAPHIC SITES, THE R2D2 TB NETWORK II WILL ADVANCE THE NEXT GENERATION OF TB DIAGNOSTICS.

San Francisco Regents Of The University Of California

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]

San Francisco, California 94110 United States

Single Zip Code

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 98% from $2,408,741 to $4,760,584.