Follow the Money

CE147274 · Department of Health and Human Services · Health Resources and Services Administration · MO · award runs 2022-09-01 to 2025-08-31

COMMUNITY PROJECT FUNDING/CONGRESSIONALLY DIRECTED SPENDING - CONSTRUCTION - THIS PROJECT INCLUDES THREE CONSTRUCTION PROJECTS: THE ROY BLUNT NEXTGEN PRECISION HEALTH BUILDING INITIAL CONSTRUCTION (NGPH CONSTRUCTION); THE ROY BLUNT NEXTGEN PRECISION HEALTH BUILDING LEVEL 4 SHELL SPACE FITOUT (NGPH FITOUT); AND THE NEXTGEN UNIVERSITY OF MISSOURI RESEARCH REACTOR WEST BUILDING ADDITION (NEXTGEN MURR WEST). NGPH CONSTRUCTION, NGPH FITOUT, AND NEXTGEN MURR WEST PROVIDE THE FACILITIES AND RESOURCES NEEDED TO INTEGRATE MULTIDISCIPLINARY LABORATORY SPACE WITH ADVANCED ANALYTICAL INSTRUMENTATION, COMPUTATIONAL PROCESSING, AND PILOT-SCALE MANUFACTURING TO CREATE A COMPREHENSIVE PRECISION HEALTH RESEARCH PIPELINE THAT ENCOMPASSES THE ENTIRE UNIVERSITY SYSTEM. PRIOR, INITIAL CONSTRUCTION EXPENSES FOR THE NGPH CONSTRUCTION AND CONSTRUCTION NGPH FITOUT INCLUDE EXTERIOR CONSTRUCTION, INTERIOR CONSTRUCTION OF OFFICE AND LAB SPACES, AND EQUIPMENT PURCHASES. THE NEXTGEN MURR WEST ADDITION INVOLVES BOTH EXTERIOR AND INTERIOR CONSTRUCTION AND EQUIPMENT PURCHASE TO EXPAND THE OPERATIONS AT MURR AND IMPROVE ITS SERVICE TO SOCIETY. AGGRESSIVE AND DEADLY DISEASE LIKE CANCER, HEART DISEASE, AND KIDNEY DISEASE HAVE IMPACTED ALL AREAS OF THE UNITED STATES. UNFORTUNATELY, MISSOURI HAS BEEN DISPROPORTIONALLY AFFECTED. ACCORDING TO THE 2019 CDC STATISTICS, MISSOURI IS RANKED 4THHIGHEST FOR MOST KIDNEY DISEASE DEATHS AND 12TH HIGHEST FOR CANCER DEATHS, NATIONALLY. HOWEVER, THE UNIVERSITY OF MISSOURI (MU) HAS ALSO BEEN AT THE FOREFRONT WITH RESEARCH AND TREATMENTS AT A LOCAL TO GLOBAL LEVEL. THIS PROJECT WILL FURTHER THESE ADVANCEMENTS. THIS PROJECT SUPPORTS THE UNIVERSITY OF MISSOURI’S NEXTGEN PRECISION HEALTH GOAL TO UNITE TALENTED INVESTIGATORS FROM ACROSS THE UM SYSTEM: UNIVERSITY OF MISSOURI – COLUMBIA (MU), UNIVERSITY OF MISSOURI – KANSAS CITY (UMKC), MISSOURI UNIVERSITY OF SCIENCE AND TECHNOLOGY (MISSOURI S&T), AND UNIVERSITY OF MISSOURI – ST. LOUIS (UMSL) WITH A CUTTING-EDGE RESEARCH FACILITY DEDICATED TO SOLVING OUR MOST PRESSING HEALTH CONCERNS. DESIGNED TO EMPOWER INTERDISCIPLINARY COLLABORATION AS THE CORNERSTONE OF THE INITIATIVE, THE BUILDING WILL PROVIDE THE COLLABORATIVE NEXUS FOR ACTIVITY FOCUSED ON SPEEDING THE PATH TO NEW TREATMENTS AND MAKING THEM ACCESSIBLE TO PEOPLE IN NEED, FASTER THAN TRADITIONAL BENCH-TO-BEDSIDE METHODS. AS ONE OF ONLY SIX PUBLIC UNIVERSITIES IN THE COUNTRY WITH SCHOOLS OR COLLEGES OF MEDICINE, VETERINARY MEDICINE, AGRICULTURE, ENGINEERING, ARTS AND SCIENCE, LAW, AND A POWERFUL RESEARCH REACTOR — ALL ON ONE CAMPUS — MU IS UNIQUELY POSITIONED TO MEET THE CHALLENGES OF PRECISION HEALTH. OUR POSITION IS FURTHER STRENGTHENED BY MU HEALTH, OUR ACADEMIC HEALTH SYSTEM THAT IS HOME TO GROUNDBREAKING RESEARCH, AND HAS HEADQUARTERS LOCATED RIGHT NEXT TO THE NEXTGEN BUILDING. ADDITIONALLY, FOR MORE THAN 50 YEARS THE FACULTY AND STAFF OF THE UNIVERSITY OF MISSOURI RESEARCH REACTOR (MURR®) HAVE PROMOTED GROUNDBREAKING RESEARCH AND DEVELOPED LIFE-SAVING RADIOPHARMACEUTICALS, PROVIDING BENEFITS TO PEOPLE ACROSS THE COUNTRY AND AROUND THE WORLD. MURR IS THE HIGHEST-POWER UNIVERSITY RESEARCH REACTOR IN THE UNITED STATES, OPERATING AT 10 MEGAWATTS, 6.5 DAYS A WEEK AND 52 WEEKS A YEAR. THE MURR FACILITY ENABLES RESEARCH ACROSS MANY DISCIPLINES SUCH AS ANALYZING INDUSTRIAL MATERIALS AND DEVELOPING RADIOPHARMACEUTICALS THAT HAVE LIFESAVING CLINICAL APPLICATIONS. RESEARCH THROUGH THE UNIVERSITY OF MISSOURI’S NEXTGEN PRECISION HEALTH WILL PROVIDE MAJOR RETURNS ON INVESTMENT THROUGH HEALTHIER COMMUNITIES, BETTER EDUCATIONAL OPPORTUNITIES FOR STUDENTS, GAME-CHANGING ECONOMIC DEVELOPMENT, AND NEW PRECISION HEALTH TECHNOLOGIES FOR MISSOURI AND BEYOND. COMBINING OUR COLLECTIVE EXPERTISE AND WORLD-CLASS RESOURCES WILL ALLOW MU RESEARCHERS TO EFFECTIVELY ANALYZE AND DEVELOP SOLUTIONS TO OUR CRITICAL HEALTH CHALLENGES AND DELIVER TREATMENTS WITH ACCESS FOR ALL, IMPROVING THE LIVES OF PEOPLE LIVING IN URBAN, RURAL AND REMOTE COMMUN

NE11OE000032 · Department of Health and Human Services · Centers for Disease Control and Prevention · PR · award runs 2022-12-01 to 2027-11-30

STRENGTHENING U.S. PUBLIC HEALTH INFRASTRUCTURE, WORKFORCE, AND DATA SYSTEMS - SINCE 2006, PUERTO RICO HAS BEEN HIT BY AN ECONOMIC CRISIS THAT FORCED THE GOVERNMENT TO MAKE TOUGH BUT NECESSARY DECISIONS REGARDING ITS SPENDING WHILE PROMOTING BETTER USE OF SCARCE RESOURCES. AS A RESULT, A SIGNIFICANT NUMBER OF GOVERNMENT EMPLOYEES WERE LAID OFF, CAUSING THE PUERTO RICO DEPARTMENT OF HEALTH (PRDOH) TO FACE AN EVER-INCREASING STAFF SHORTAGE. IN ADDITION, THE RESULTS OF AN ORGANIZATIONAL CAPACITY ANALYSIS SHOW THAT THE AVERAGE AGE OF PRDOH CURRENT STAFF IS 52 YEARS AND THEY HAVE AN AVERAGE OF 21 YEARS OF EXPERIENCE IN GOVERNMENT. THIS HAS LED TO AN AGING OF HUMAN RESOURCES AND A LOOMING LOSS OF KNOWLEDGE AND INSTITUTIONAL MEMORY. IN 2017, HURRICANES IRMA AND MARIA DESTROYED LARGE PARTS OF THE ISLAND, LEAVING MANY PUERTO RICANS WITHOUT A SAFE PLACE TO LIVE AND TRIGGERING A SIGNIFICANT BRAIN DRAIN TO THE MAINLAND TO FIND BETTER JOB OPPORTUNITIES. AN EARTHQUAKE SWARM HIT SOUTHERN PUERTO RICO IN EARLY 2020, AND A LOCKDOWN WAS DECLARED IN THE FIRST QUARTER OF THAT YEAR AS A COVID -19 PREVENTION AND CONTROL STRATEGY. THE COVID -19 PANDEMIC HIGHLIGHTED THE VULNERABILITY OF HEALTH CARE WORKERS, WHO WERE THE POPULATION MOST AFFECTED BY THE SARS-COV -2, MORE LIKELY TO BE INFECTED, AND FACED UNFAVORABLE WORKING CONDITIONS DUE TO LABOR SHORTAGES. COVID THE -19 PANDEMIC PLACED A GREAT BURDEN NOT ONLY ON GOVERNMENTS, BUT ALSO ON HEALTH SYSTEMS, WHICH, AS IN THE CASE OF PUERTO RICO, HAVE FRAGILE INFRASTRUCTURE. THE SHORTAGE OF HEALTH PROFESSIONALS HAS BECOME ONE OF THE MAIN PROBLEMS NOT ONLY IN PUERTO RICO, BUT WORLDWIDE, AS IT HAS A GREAT IMPACT ON GLOBAL HEALTH SECURITY. THE STRAIN PLACED ON PUERTO RICO'S PUBLIC HEALTH SYSTEM BY RECENT THREATS TO PUBLIC HEALTH HAS EXACERBATED INEQUITIES FOR MARGINALIZED POPULATIONS. TO MEET THE NEEDS OF THE POPULATION, IT IS CRITICAL TO IMPLEMENT A REALISTIC SUCCESSION PLAN TO INCREASE INFRASTRUCTURE CAPACITY, WHICH WOULD NOT BE POSSIBLE WITHOUT THE SUPPORT OF STATE AND FEDERAL FUNDS ALLOCATIONS (COMPONENT A.1: WORKFORCE). IN ADDITION, WITH THIS FUNDING OPPORTUNITY, THE PRDOH WOULD CONTINUE TO ADVANCE THE ACCREDITATION PROCESS THAT BEGAN IN 2019 (COMPONENT A.2: FOUNDATIONAL CAPABILITIES), WHICH WOULD IMPACT OTHER ESSENTIAL CAPABILITIES THAT WOULD CREATE THE NECESSARY INFRASTRUCTURE TO PROVIDE EQUITABLE AND ESSENTIAL PUBLIC HEALTH SERVICES. FINALLY, THIS OPPORTUNITY WOULD ALLOW THE GROUNDWORK TO BE LAID FOR ANY DATA MODERNIZATION INITIATIVE TO PREVENT FURTHER DEGRADATION OF THE PRDOH IT INFRASTRUCTURE (COMPONENT A.3: DATA MODERNIZATION). ONE HUNDRED SEVENTY-ONE (171) PUBLIC HEALTH PROFESSIONALS WILL BE RECRUITED AND RETAINED THROUGH THESE PROJECT FUNDS: ONE HUNDRED FORTY-NINE (149) FOR COMPONENT A.1: WORKFORCE, NINETEEN (19) FOR COMPONENT A.2: FOUNDATIONAL CAPABILITIES AND THREE (3) FOR COMPONENT A.3: DATA MODERNIZATION. THESE PROFESSIONAL STAFF INCLUDE THE FOLLOWING CLASSIFICATION CATEGORIES: AGENCY LEADERSHIP AND MANAGEMENT, OFFICE AND ADMINISTRATIVE SUPPORT, BUSINESS AND FINANCIAL OPERATIONS, EPIDEMIOLOGISTS, STATISTICIANS, DATA SCIENTISTS AND OTHER DATA ANALYSTS, INFORMATION TECHNOLOGY AND DATA SYSTEM DATA SYSTEMS STAFF, PUBLIC INFORMATION AND PUBLIC POLICY STAFF, BEHAVIORAL HEALTH AND SOCIAL SERVICES, PUBLIC HEALTH CLINICIANS, ENVIRONMENTAL HEALTH WORKERS, ANIMAL CONTROL AND COMPLIANCE/INSPECTION STAFF AND OTHER UNCATEGORIZED PROFESSIONALS.

U19AI171403 · Department of Health and Human Services · National Institutes of Health · GA · award runs 2022-05-16 to 2026-10-31

ANTIVIRAL COUNTERMEASURES DEVELOPMENT CENTER (AC/DC) - THE ANTIVIRAL COUNTERMEASURES DEVELOPMENT CENTER (AC/DC) WILL TARGET PATHOGENS IN FIVE FAMILIES OF RNA VIRUSES WITH SIGNIFICANT PANDEMIC POTENTIAL, WITH THE OVERARCHING GOAL TO IDENTIFY AND DEVELOP ORALLY BIOAVAILABLE, DIRECT ACTING ANTIVIRAL DRUGS (DAAS). SPECIFIC VIRAL TARGETS INCLUDE ZOONOTIC AND HUMAN VIRUSES IN THE CORONAVIRUS, PARAMYXOVIRUS, FLAVIVIRUS, PICORNAVIRUS, AND TOGAVIRUS FAMILIES. THE AC/DC MPIS DRS. PAINTER AND PLEMPER, WHO WILL LEAD THIS EFFORT, HAVE DEMONSTRATED THE POWER OF THEIR COMBINED EXPERTISE IN IDENTIFYING NOVEL ANTIVIRAL CHEMOTYPES AND ADVANCING THEM FROM HIT STAGE TO CLINICAL CANDIDATE, BEST EXEMPLIFIED BY THEIR SUCCESSFUL JOINT WORK ON MOLNUPIRAVIR, CONSIDERED FOR EMERGENCY APPROVAL AS THE FIRST ORAL THERAPEUTIC FOR THE TREATMENT OF COVID- 19. THE MPIS HAVE ASSEMBLED A TEAM OF RECOGNIZED EXPERTS IN THE BIOLOGY OF THE VIRAL PATHOGENS BEING TARGETED. THEIR EFFORTS ARE ORGANIZED INTO FIVE SYNERGISTIC PROJECTS SUPPORTED BY CUTTING-EDGE TECHNICAL EXPERTISE IN FIVE AC/DC SCIENTIFIC CORES, COVERING KEY AREAS OF PRECLINICAL DRUG DISCOVERY AND DEVELOPMENT. A NUMBER OF THE CORE LEADERS HAVE SIGNIFICANT EXPERIENCE IN THE DEVELOPMENT OF ANTIVIRALS IN THE PHARMA AND BIOTECHNOLOGY SECTORS. THE AC/DC WILL ACHIEVE ITS OVERARCHING GOAL IN TWO MAJOR OBJECTIVES. PILOT STUDIES IDENTIFIED TWO CHEMICALLY DISTINCT BROAD-SPECTRUM RIBONUCLEOSIDE ANALOGS AND TWO NON-NUCLEOSIDE VIRAL POLYMERASE INHIBITORS WITH CONFIRMED ORAL EFFICACY AGAINST ONE OR SEVERAL OF THE FIVE VIRAL FAMILIES TARGETED, INCLUDING A NOVEL CHEMOTYPE THAT IS ORALLY EFFICACIOUS AGAINST SARS-COV-2 IN RELEVANT ANIMAL MODELS. OBJECTIVE 1 WILL ADVANCE THIS SET OF FOUR NOVEL DAA LEADS THROUGH FINAL SYNTHETIC OPTIMIZATION AND DE-RISKING IN ANIMAL MODELS AND PRIMARY HUMAN ORGANOIDS AS IMMEDIATE DELIVERABLES TO MITIGATE THE URGENT THREAT TO PUBLIC HEALTH. SIMULTANEOUSLY, OBJECTIVE 2 WILL IDENTIFY ADDITIONAL VIABLE HIT CHEMOTYPES TO EXPAND THE AC/DC'S ANTIVIRAL PORTFOLIO BY LEVERAGING CENTER EXPERTISE IN REVERSE GENETICS OF ALL VIRAL TARGET FAMILIES, EXISTING GROUNDBREAKING REPORTER VIRUS TECHNOLOGIES, AND HIGH-THROUGHPUT SCREENING UNDER STANDARD AND HIGH BIOCONTAINMENT CONDITIONS. HITS WILL BE COUNTERSCREENED AGAINST ALL CENTER TARGET FAMILIES, MOLECULAR VIRAL TARGETS AND MECHANISM OF ACTION CHARACTERIZED, AND A POTENCY, PHARMACOKINETICS, AND PHARMACOPHORE-DRIVEN SYNTHETIC DEVELOPMENT PROGRAM LAUNCHED TO IDENTIFY OPTIMIZED LEADS. ALL DATA GENERATED BY THE PROJECTS AND CORES WILL BE EVALUATED CENTER-WIDE UTILIZING QUANTITATIVE PERFORMANCE MILESTONES OF A DEFINED AC/DC LEAD ADVANCEMENT CASCADE THAT GOVERNS THE PROGRESSION OF A CHEMOTYPE FROM HIT TO CLINICAL DEVELOPMENT CANDIDATE.

R24AC00488 · Department of the Interior · Bureau of Reclamation · NE · award runs 2024-09-17 to 2029-12-31

THROUGH THIS AGREEMENT, THE NEBRASKA COMMUNITY FOUNDATION WILL PROVIDE FINANCIAL AND ADMINISTRATIVE SUPPORT TO THE GOVERNANCE COMMITTEE OF THE PLATTE RIVER RECOVERY IMPLEMENTATION PROGRAM (PROGRAM). THE PROGRAM PROVIDES ENDANGERED SPECIES ACT COMPLIANCE, WHICH IS CRUCIAL FOR THE CONTINUED OPERATION OF RECLAMATIONS PROJECTS ON THE NORTH PLATTE AND SOUTH PLATTE RIVERS. THE CONTINUED OPERATION OF THESE PROJECTS WILL ALLOW RECLAMATION TO DELIVER STORAGE WATER FOR IRRIGATION AND MUNICIPAL AND INDUSTRIAL PURPOSES, AND TO CONTINUE TO GENERATE HYDROPOWER, FOR THE BENEFIT OF THE PUBLIC. THE OPERATION OF THESE PROJECTS PROVIDES FOR RECREATIONAL OPPORTUNITIES FOR THE GENERAL PUBLIC, AND THE PUBLIC WILL ALSO BENEFIT FROM INCREASED ACCESS TO PROGRAM LANDS IN NEBRASKA FOR CERTAIN RECREATIONAL USES DURING CERTAIN TIMES OF THE YEAR.SPECIFIC PROJECT ACTIVITIES INCLUDE:PROGRAM ADMINISTRATIONPROGRAM LAND PLAN IMPLEMENTATIONLAND ACQUISITIONPROGRAM WATER PLAN IMPLEMENTATION (NON-ACQUISITION)PROGRAM WATER PLAN IMPLEMENTATION (ACQUISITION)PROGRAM ADAPTIVE MANAGEMENT PLAN IMPLEMENTATIONTHIS IS A MANDATORY AGREEMENT, AUTHORIZED IN PUBLIC LAW 110-229, THE PLATTE RIVER RECOVERY IMPLEMENTATION PROGRAM EXTENSION ACT.

UM1TR004406 · Department of Health and Human Services · National Institutes of Health · NC · award runs 2023-04-28 to 2030-03-31

NORTH CAROLINA TRANSLATIONAL AND CLINICAL SCIENCES INSTITUTE (NC TRACS) - PROJECT SUMMARY THE NORTH CAROLINA TRANSLATIONAL AND CLINICAL SCIENCES INSTITUTE (TRACS) IS A DYNAMIC REGIONAL NETWORK OF UNIVERSITIES, RESEARCH INSTITUTES, HEALTHCARE PROVIDERS, AND >250 COMMUNITY COLLABORATORS ACROSS OUR STATE. BASED AT UNC CHAPEL HILL, TRACS HAS STRATEGICALLY FOSTERED PARTNERSHIPS WITH NC A&T, THE LARGEST HBCU IN THE U.S., WHICH BRINGS EXPERTISE IN HEALTH EQUITY RESEARCH, WORKFORCE DEVELOPMENT, ENGINEERING, AND DATA SCIENCE, AND NC STATE, WITH A NATIONALLY RANKED SCHOOL OF VETERINARY MEDICINE AND ADDITIONAL EXPERTISE IN ENGINEERING AND COMPUTER SCIENCE. OVER THE NEXT SEVEN YEARS, WE WILL CATALYZE DEVELOPMENT, TESTING, IMPLEMENTATION, AND DISSEMINATION OF TRANSLATIONAL SCIENCE AND RESEARCH TO IMPROVE HUMAN HEALTH, WITH AN EXPLICIT FOCUS ON ADVANCING HEALTH EQUITY BY COMPLETING OUR OVERALL AIMS. AIM 1: PERFORM AND SUPPORT RESEARCH THAT ADVANCES THE SCIENCE OF TRANSLATION WITH THE GOAL OF CLEARING BARRIERS TO RAPID TRANSLATION OF RESEARCH TOWARDS IMPLEMENTATION OF BEST EVIDENCE TO OUR PATIENTS AND THEIR COMMUNITIES. AIM 2: MAXIMIZE THE INFORMATIVENESS OF TRANSLATIONAL RESEARCH, TO DRIVE ITS IMPACT TO IMPROVE CLINICAL BENEFITS AND REDUCE HARMS WITH PARTICULAR ATTENTION TO POPULATIONS IMPACTED BY HEALTH INEQUITIES. AIM 3: TRAIN AND MAINTAIN A DIVERSE, EXPERT, MULTIDISCIPLINARY TRANSLATIONAL RESEARCH WORKFORCE AT ALL PROFESSIONAL LEVELS, PREPARED TO MEET THE CHALLENGES OF CURRENT AND FUTURE HEALTH CRISES. AIM 4: IMPLEMENT EVIDENCE-BASED STRATEGIES TO IMPROVE HUMAN HEALTH USING OUR LEARNING HEALTH CARE SYSTEM AS OUR LABORATORY. WE HAVE INTENSIFIED OUR EFFORTS IN HEALTH EQUITY AS WELL AS DISSEMINATION AND IMPLEMENTATION, RECOGNIZING THAT THESE ARE THE CRITICAL BARRIERS TO EFFECTIVE TRANSLATION OF INNOVATION TO HEALTH. WE WILL CAPITALIZE ON (I) THE SUBSTANTIAL RESOURCES OF OUR LEARNING HEALTH CARE SYSTEM AND (II) THE COLLECTIVE EXPERTISE OF TRACS, HONED OVER 14 YEARS OF SUPPORTING WORLD-CLASS TRANSLATIONAL RESEARCH, TO INTEGRATE THE PRINCIPLES OF SOCIAL JUSTICE IN ALL OUR SERVICES AND TRAININGS AND TO REALIZE OUR VISION OF “A HEALTHIER NORTH CAROLINA THROUGH INNOVATION”. WE WILL INNOVATE INCLUSIVE METHODS AND PROCESSES, ENGENDER TRUST, AND RECRUIT RESEARCH PARTICIPANTS WHO REFLECT THE DIVERSITY OF OUR STATE. WE WILL IMPLEMENT OUR ADVANCES TO ENSURE BENEFITS FOR OUR PARTICIPANTS, THEIR COMMUNITIES AND PATIENTS EVERYWHERE. WITH BROAD STAKEHOLDER ENGAGEMENT AND RIGOROUS EVALUATION OF OUR EFFORTS, WE WILL MAXIMIZE THE RELEVANCE OF OUR RESEARCH TO THOSE WE SERVE. TRACS WILL LEAD AND SUPPORT EFFORTS ACROSS THE CTSA CONSORTIUM TO CREATE A MORE EFFICIENT, INCLUSIVE RESEARCH ENVIRONMENT TO MITIGATE HEALTH DISPARITIES.

U19AG074866 · Department of Health and Human Services · National Institutes of Health · PA · award runs 2022-09-01 to 2027-08-31

GENERATION, CHARACTERIZATION, AND VALIDATION OF MARMOSET MODELS OF ALZHEIMER'S DISEASE - PROJECT SUMMARY OVERALL ALZHEIMER’S DISEASE (AD) IS A DEVASTATING NEURODEGENERATIVE DISORDER AFFECTING NEARLY 6 MILLION AMERICANS AND IS EXPECTED TO INCREASE OVER THE NEXT SEVERAL YEARS. OUR LIMITED UNDERSTANDING OF THE MECHANISMS THAT TRIGGER THE EMERGENCE OF AD HAS CONTRIBUTED TO THE LACK OF INTERVENTIONS THAT STOP, PREVENT, OR FULLY TREAT THIS DISEASE. WE PROPOSE TO ESTABLISH THE MARMOSET AS THE FIRST PRIMATE-SPECIFIC MODEL TO REVEAL THE EARLIEST CELLULAR AND MOLECULAR EVENTS OF AD PROCESSES AND ALLOW CHARTING AD PROGRESSION FROM ITS INCEPTION. TO DO SO, WE WILL DRAW FROM A SELF-SUFFICIENT AND LARGE COLONY OF RESEARCH MARMOSETS WITH DEDICATED VETERINARY AND HUSBANDRY TEAMS, STATE-OF-THE-ART IN VIVO NEUROIMAGING AND MOLECULAR ASSAYS, AND A MULTIDISCIPLINARY TEAM OF EXPERTS IN AGING BIOLOGY, AD GENETICS AND GENOMICS, ANIMAL MODEL DEVELOPMENT AND CHARACTERIZATION, BEHAVIORAL AND COGNITIVE PHENOTYPING, AND MARMOSET GENE-EDITING TECHNOLOGIES. OUR PROPOSAL’S OVERARCHING GOALS ARE TO DEVELOP MARMOSET MODELS OF EARLY-ONSET AD (EOAD) AND LATE-ONSET AD (LOAD) TO ENABLE THE INVESTIGATION OF THE UNDERLYING CELLULAR AND MOLECULAR ROOT CAUSES OF THE PATHOGENESIS AND PROGRESSION OF AD AND SUPPORT FUTURE TRANSLATIONAL STUDIES. WE BELIEVE THAT THE SIMULTANEOUS ASSESSMENT OF GENETIC, MOLECULAR, FUNCTIONAL, BEHAVIORAL, AND PATHOLOGICAL PHENOTYPES IN MARMOSETS WILL PROVIDE TRANSLATABLE KNOWLEDGE OF THE ORIGINS AND PROGRESSION OF AD IN HUMAN POPULATIONS. FURTHERMORE, WE POSIT THAT THE COMPREHENSIVE STUDY OF GENE-EDITED MARMOSET MODELS OF AD FROM NEURODEVELOPMENT THROUGH AGING WILL IDENTIFY EMERGING PHENOTYPES THAT PRECEDE FRANK NEUROPATHOLOGY. OUR PROPOSAL CONSISTS OF 3 INTEGRATED RESEARCH PROJECTS THAT AIM TO: (1) CONDUCT CHARACTERIZATION AND VALIDATION OF PSEN1 MUTATIONS IN MARMOSETS AS A MODEL FOR THE STUDY OF EOAD, AND INVESTIGATE EARLY LIFE MOLECULAR DETERMINANTS OF AD DISEASE PATHOGENESIS ASSOCIATED WITH GENETIC RISK FOR EOAD; (2) IDENTIFY AND ENHANCE LOAD-RELATED SIGNATURES IN OUTBRED AND GENETICALLY-ENGINEERED MARMOSETS; AND (3) CONDUCT A COMPARATIVE MULTIMODAL PHENOTYPIC CHARACTERIZATION OF MARMOSET MODELS OF AD. THESE PROJECTS WILL BE SUPPORTED BY 5 RESEARCH CORES FOCUSED ON PROJECT ADMINISTRATION, BIOINFORMATICS, GENETIC ENGINEERING, MULTIMODAL DISEASE CHARACTERIZATION, AND VETERINARY AND COLONY MANAGEMENT. THESE SUPPORTING CORES WILL INTEGRATE MARMOSET AND HUMAN GENOMIC SIGNATURES AND PROVIDE DATA DISSEMINATION AND RESOURCES TO THE GREATER RESEARCH COMMUNITY AS PART OF OUR COMMITMENT TO OPEN SCIENCE, GENERATE NOVEL GENE-EDITED MARMOSET MODELS OF AD, DEVELOP OPTIMIZED PROTOCOLS FOR STUDYING DISEASE ONSET AND TRAJECTORY IN LINE WITH CLINICAL PROTOCOLS, EVALUATE THERAPEUTIC STRATEGIES, AND PROVIDE SPECIALIZED ANIMAL CARE AND SUPPORT, RESPECTIVELY, ALLOWING COMPLETE CHARACTERIZATION OF THE MARMOSET MODELS. AT THE CONCLUSION OF THIS PROJECT, WE WILL HAVE GENETICALLY ENGINEERED THREE AD RISK VARIANTS INTO MARMOSET MODELS, ESTABLISHED A DISEASE CHARACTERIZATION PIPELINE FOR COMPREHENSIVE PHENOTYPING, AND SHARED THESE RESOURCES WITH THE GREATER RESEARCH COMMUNITY.

P01AI077774 · Department of Health and Human Services · National Institutes of Health · TX · award runs 2008-08-15 to 2027-02-28

PATHOGENESIS, TRANSMISSION AND DETECTION OF ZOONOTIC PRION DISEASES (P01)

NU50CK000648 · Department of Health and Human Services · Centers for Disease Control and Prevention · MN · award runs 2024-01-01 to 2028-12-31

MINNESOTA DEPARTMENT OF HEALTH EMERGING INFECTION PROGRAM - THE MINNESOTA DEPARTMENT OF HEALTH (MDH) IS APPLYING TO CONTINUE TO BE PART OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION EMERGING INFECTIONS PROGRAM (EIP). IN 1995, MDH BEGAN AS ONE OF THE FOUR ORIGINAL EIP SITES, AND WE HAVE CONSISTENTLY BEEN A PRODUCTIVE AND LEADING EIP SITE EVER SINCE. THE PURPOSE OF THE PROPOSED WORK IS TO PROVIDE HIGH QUALITY SCIENTIFIC INFORMATION TO MONITOR EMERGING INFECTIOUS DISEASES THROUGH ACTIVE, POPULATION-BASED SURVEILLANCE, CONDUCT APPLIED EPIDEMIOLOGIC STUDIES, IMPLEMENT AND EVALUATE PUBLIC HEALTH INTERVENTION STUDIES, INFORM PUBLIC HEALTH POLICY, AND SERVE AS A FLEXIBLE PARTNER ABLE TO RAPIDLY RESPOND TO EMERGING THREATS. MDH PLANS TO CONTINUE WITH CORE EIP SURVEILLANCE FUNCTIONS, INCLUDING: ABCS (SELECT BACTERIAL PATHOGEN SURVEILLANCE, EFFECTIVENESS STUDIES FOR VACCINES, GUIDELINES, AND OTHER PREVENTION MEASURES); FOODNET (SURVEILLANCE FOR ENTERIC PATHOGENS TO DETERMINE TRENDS AND RISK FACTORS); FLUSURV-NET (SURVEILLANCE FOR HOSPITALIZED CASES OF INFLUENZA AND VACCINE-EFFECTIVENESS STUDIES); RSV-NET (SURVEILLANCE FOR HOSPITALIZED CASES OF RESPIRATORY SYNCYTIAL VIRUS INFECTION AND SPECIAL STUDIES); COVID-NET (SURVEILLANCE FOR HOSPITALIZED CASES OF COVID-19 AND SPECIAL STUDIES); HEALTHCARE ASSOCIATED INFECTIONS (HAI) (SURVEILLANCE, ANTIMICROBIAL RESISTANCE, RISK FACTOR STUDIES, HAI PREVALENCE, AND ANTIMICROBIAL USE STUDIES); TICKNET (SURVEILLANCE FOR LYME DISEASE AND OTHER TICKBORNE DISEASES, RISK FACTOR STUDIES, PREVENTION AND CONTROL EVALUATION); AND, SURVEILLANCE FOR UNEXPLAINED DEATHS AND CRITICAL ILLNESSES OF POSSIBLE INFECTIOUS ETIOLOGY. MDH PROPOSES TO EXPAND EIP ACTIVITIES TO INCLUDE DATA MODERNIZATION AND INFRASTRUCTURE, ENHANCED SURVEILLANCE FOR PRION DISEASES (E.G., CREUTZFELDT-JAKOB DISEASE), AND MPOX VACCINE EFFECTIVENESS EVALUATION. FUNDING IS REQUESTED FOR EPIDEMIOLOGY, PUBLIC HEALTH LABORATORY, AND INFORMATION TECHNOLOGY STAFF AND SUPPLIES. MDH HAS CONSISTENTLY BEEN AND WILL CONTINUE TO BE A LEADER IN CARRYING OUT ROUTINE EIP FUNCTIONS, SUCH AS COLLECTING AND PROVIDING HIGH QUALITY DATA AND CLINICAL ISOLATES, WHILE ALSO ACTIVELY DEVELOPING STUDY PROTOCOLS, PROVIDING OVERALL SCIENTIFIC LEADERSHIP, TRAINING PUBLIC HEALTH STUDENTS AND CLINICIANS, AND DISSEMINATING IMPORTANT PUBLIC HEALTH FINDINGS. WE WILL CONTINUE OUR LONG-STANDING EXTERNAL PARTNERSHIPS WITH COLLABORATORS FROM THE UNIVERSITY OF MINNESOTA SCHOOLS OF PUBLIC HEALTH, MEDICINE, AND VETERINARY MEDICINE; MINNESOTA INFECTION PREVENTIONISTS (APIC-MN); THE MAYO CLINIC; AND LOCAL AND TRIBAL PUBLIC HEALTH AGENCIES. ALL THIS WILL BE DONE UNDER RIGOROUS OVERSIGHT BY MDH EIP LEADERS, MANY OF WHOM HAVE 20-25 YEARS OF EIP EXPERIENCE. EIP WORK WILL BE ACCOMPLISHED WHILE OBSERVING PROTECTION OF HUMAN SUBJECTS IN RESEARCH PROVISIONS, AND PRE-ESTABLISHED MEASURES OF EFFECTIVENESS WILL BE MET CONSISTENTLY.

F18AF01209 · Department of the Interior · U.S. Fish and Wildlife Service · FL · award runs 2018-07-01 to 2025-06-30

FL-F-FLORIDA'S FRESHWATER FISHERIES MANAGEMENT PROGRAM

NU51CK000376 · Department of Health and Human Services · Centers for Disease Control and Prevention · UT · award runs 2024-08-01 to 2029-07-31

UTAH'S PROPOSAL FOR ACTIVITIES WITHIN THE 2024 EPIDEMIOLOGY AND LABORATORY CAPACITY FOR PREVENTION AND CONTROL OF EMERGING INFECTIOUS DISEASES (ELC) COOPERATIVE AGREEMENT. - • A. CROSS-CUTTING EPI AND LAB CAPACITY: ASSESSMENTS AND TRAINING; ENHANCE SKILLS; BUILD SUPPORT AND CAPACITY; IMPROVE DISEASE DASHBOARDS; CONDUCT APPROPRIATE TESTING; IMPROVE EFFICIENCY; IMPROVE DATA QUALITY; AUTOMATE DATA EXPORT AND ANALYSIS; COLLABORATE WITH PARTNERS; LAB LANDSCAPE ANALYSIS. • B. ELC LEADERSHIP, MANAGEMENT, AND ADMINISTRATION: PLAN AND COORDINATE ACTIVITIES; MANAGE FINANCIAL ASPECTS; IMPROVE OUTCOMES; REPORT ON PROGRESS. • C. HEALTH INFORMATION SYSTEMS CAPACITY: IMPROVE FUNCTIONALITY; SUSTAINABILITY PLAN; EVALUATE DATA; ADDRESS GAPS; SIMPLIFY REVIEW OF DATA QUALITY AND COMPLIANCE; IDENTIFY BEST PRACTICES; IMPROVE DATA QUALITY; COLLABORATE FOR AND STREAMLINE ONBOARDING; MODERNIZE PIPELINES AND REPORTING; SUPPORT MODERNIZED INFRASTRUCTURE; MIGRATE SYSTEMS TO CLOUD-BASED/HOSTED ENVIRONMENTS; IMPLEMENT SCALABLE DATA MANAGEMENT. • D. ADVANCED MOLECULAR DETECTION: AMD REGIONAL WORKFORCE DEVELOPMENT TRAINING LEAD; DEVELOP AMD BIOINFORMATICS RESOURCES. • E. NATIONAL WASTEWATER SURVEILLANCE SYSTEM: DATA COORDINATION, SUBMISSION, TIMELINESS, AND QUALITY; DISSEMINATE DATA; EXPAND LAB CAPACITY; AUTOMATE DATA TRANSFER; COORDINATE AND COMMUNICATE DATA. • F. CROSS-CUTTING EMERGING ISSUES: COORDINATE WITH CDC IF FUNDED. • G. ENTERIC, FOODBORNE, WATERBORNE, AND ZOONOTIC DISEASES: IMPROVE INTERVIEW TIMELINESS AND LAB COORDINATION; TRAINING; USE DATA TO IDENTIFY PREVENTION OPPORTUNITIES; IMPLEMENT MODEL PRACTICES; TRANSLATE MATERIALS; BEGIN COLLABORATION ON PUBLIC DASHBOARD; PARTICIPATE IN STRATEGIC PLANNING; ENHANCE SURVEILLANCE; CREATE GUIDANCE FOR SPECIMENS; IMPROVE COMMUNICATION; PROMOTE AWARENESS; BUILD PARTNERSHIPS; IMPROVE METAGENOMICS METHODS. • H. HEALTHCARE-ASSOCIATED INFECTIONS, ANTIMICROBIAL RESISTANCE, AND ANTIBIOTIC STEWARDSHIP: IMPLEMENT RESPONSES; SUPPORT CASE AND OUTBREAK INVESTIGATIONS; PREVENT SPREAD OF MDROS; CONDUCT ON-SITE INFECTION PREVENTION AND CONTROL ASSESSMENTS; ADDRESS HEALTH DISPARITIES; IMPROVE ANTIBIOTIC STEWARDSHIP CAPACITY; UPDATE SOPS; PROVIDE IPC TRAINING. • I. ANTIMICROBIAL RESISTANCE LABORATORY NETWORK: MAINTAIN TRAINED STAFF; MONITOR COMPLIANCE; CONDUCT SEQUENCING; TRAIN AND MONITOR COMPETENCY; SUSTAIN AND ESTABLISH LAB CAPACITY; SURVEILLANCE ON SPECIFIC ORGANISMS; COLONIZATION SCREENING TESTING; SUPPORT EPI INVESTIGATIONS; MAINTAIN AR LAB EXPERT; PROVIDE OUTREACH, DEVELOP PROTOCOLS; MAINTAIN AND SUSTAIN REPORTING. • J. ENHANCED SURVEILLANCE FOR VACCINE-PREVENTABLE DISEASE AND RESPIRATORY DISEASES: MAINTAIN STAFF; COLLECT CASE DATA; INCREASE REPORTING; OUTBREAK INVESTIGATIONS; IMPROVE SURVEILLANCE; SUPPORT TESTING CAPACITY; LINKAGE OF DATA; COORDINATE ACTIVITIES. • K. VECTOR-BORNE DISEASES AND TICK-ASSOCIATED CONDITIONS: IDENTIFY AND REPORT CASES AND BLOOD DONATIONS; MMG ONBOARDING; COLLECT AND REPORT PASSIVE DATA; PROVIDE GUIDANCE; CONDUCT PATHOGEN TESTING; ANALYZE AND INTERPRET DATA; MAINTAIN AND ENHANCE TESTING CAPACITY; PROFICIENCY TESTING; OUTREACH. • L. PRION SURVEILLANCE: IDENTIFY AND INVESTIGATE CASES; USE SURVEILLANCE; SUPPORT EVIDENCE-BASED AND COST-EFFECTIVE POLICIES; WORK COLLABORATIVELY WITH PARTNERS; IDENTIFY AUTOPSY FACILITIES; CONDUCT OUTREACH; DISSEMINATE INFORMATION ON PRION DISEASE; PROVIDE EDUCATION. • M. MYCOTICS. DETECTING AND PREVENTING FUNGAL INFECTIONS: USE CASE DEFINITIONS; CONDUCT ENHANCED SURVEILLANCE; REPORT OUTBREAKS; COLLABORATE WITH CDC; PARTICIPATE IN FUNGAL OUTBREAK INVESTIGATIONS; ESTABLISH FUNGAL TESTING CAPACITY; LAB PERSONNEL TRAINING; DISSEMINATE MATERIALS AND INFORMATION; MAINTAIN PARTNERSHIPS; IDENTIFY AND IMPLEMENT INTERVENTIONS. • R. RABIES SURVEILLANCE AND LABORATORY CAPACITY: SAMPLE COLLECTION AND TESTING. • S. SURVEILLANCE FOR EMERGING THREATS TO PREGNANT PEOPLE AND INFANTS NETWORK: DEVELOP CASE ASCERTAINMENT PLAN; DEVELOP DATA LINKAGES; CONDUCT CASE ASCERTAINMENT AND FOLLOW-UP; SPECIFY DATA ELEMENTS; MODERNIZE CORE SURVEILLANCE CAPACITY; WORK WITH PARTNERS; PERFORM OUTREACH; ANALYZE AND PREPARE DATA; SPECIFY NEW PROCESSES.

NU51CK000341 · Department of Health and Human Services · Centers for Disease Control and Prevention · NC · award runs 2024-08-01 to 2029-07-31

NC'S EPIDEMIOLOGY AND LABORATORY CAPACITY FOR PREVENTION AND CONTROL OF EMERGING INFECTIOUS DISEASES - NORTH CAROLINA IS THE 9TH MOST POPULOUS U.S. STATE, WITH AN ESTIMATED POPULATION OF NEARLY 11 MILLION PERSONS. THE POPULATION HAS GROWN MORE THAN 12% SINCE THE 2010 CENSUS, AND DEMOGRAPHERS SUGGEST THAT OUR STATE WILL BECOME THE 7TH MOST POPULOUS STATE BY THE EARLY 2030S. WHILE THE MAJORITY OF THE POPULATION (57%) IS CONCENTRATED IN METROPOLITAN STATISTICAL AREAS, MOST OF OUR COUNTIES (71 OF 100) REMAIN RURAL. ACCORDING TO CDC, RURAL AMERICANS FACE NUMEROUS HEALTH DISPARITIES COMPARED WITH THEIR URBAN COUNTERPARTS DUE TO A VARIETY OF FACTORS INCLUDING HIGHER RATES OF POVERTY, LESS ACCESS TO HEALTHCARE AND PUBLIC HEALTH SERVICES, AND LOWER RATES OF HEALTH INSURANCE COVERAGE. DURING THE COVID-19 PANDEMIC, THESE FACTORS CONTRIBUTED TO HIGHER MORTALITY RATES AMONG PERSONS IN RURAL COUNTIES. FURTHERMORE, RECENT STUDIES HAVE SHOWN A WIDENING GAP IN CHILDHOOD VACCINATION RATES BETWEEN URBAN AND RURAL RESIDENTS, INCREASING THE RISK OF INFECTIOUS DISEASES IN RURAL COMMUNITIES. DURING 2023, THE COMMUNICABLE DISEASE BRANCH RECEIVED AND REVIEWED SLIGHTLY MORE THAN 157,000 REPORTABLE EVENTS. FOLLOWING CASE INVESTIGATION, MORE THAN 120,000 OF THESE CASE REPORTS WERE DETERMINED TO MEET CRITERIA FOR REPORTING AND NATIONAL NOTIFICATION AND SUBMITTED TO CDC AS PART OF THE NATIONAL NOTIFIABLE DISEASE SURVEILLANCE SYSTEM. ADDITIONALLY, AS OF MARCH 27, 2024, IN BP5 OUR EPIDEMIOLOGIST ON CALL HAD PROCESSED REPORTS FROM LOCAL HEALTH DEPARTMENTS OF 1,515 POSSIBLE OUTBREAKS, AND ANSWERED 2,235 CALLS FROM LOCAL HEALTH DEPARTMENTS, MEDICAL PROVIDERS, AND THE GENERAL PUBLIC. THE OVERALL COMMUNICABLE DISEASE BURDEN IN NORTH CAROLINA IN COMPARISON TO OTHER US STATES IS DIFFICULT TO QUANTIFY, BUT SEVERAL INFECTIOUS DISEASES HAVE INCREASED SIGNIFICANTLY IN RECENT YEARS. THESE INCLUDE E. COLI, CARBAPENEMASE-PRODUCING ORGANISMS, INVASIVE MENINGOCOCCAL DISEASE, LEGIONELLOSIS, AND SYPHILIS. IN ADDITION, WE CONTINUE TO EXPERIENCE HIGH RATES OF COVID-19 ASSOCIATED MORTALITY AND CONTINUE TO RECEIVE NEW REPORTS OF MPOX INFECTIONS. NORTH CAROLINA IS A NATIONAL LEADER IN LIVESTOCK FARMING, WITH CHICKEN, TURKEY, AND PIG PRODUCTION AMONG THE TOP 3 STATES. THE SCOPE AND SCALE OF THESE INDUSTRIES IN THE STATE AS COMPARED TO OTHER STATES PRESENTS AN INCREASED RISK FOR INFECTIONS WITH ZOONOTIC POTENTIAL, AS DEMONSTRATED BY RECENT OUTBREAKS OF HIGHLY PATHOGENIC AVIAN INFLUENZA IN NORTH CAROLINA POULTRY FARMS AND IN ONE DAIRY HERD. THIS THREAT REQUIRES CLOSE COLLABORATION BETWEEN PUBLIC HEALTH AND AGRICULTURE TO ENSURE ADEQUATE CAPACITY EXISTS FOR SURVEILLANCE, INVESTIGATION, AND RESPONSE. SINCE ANTIBIOTICS ARE COMMONLY USED IN THE LIVESTOCK INDUSTRY, ROBUST EPIDEMIOLOGY AND LABORATORY CAPACITY IS ALSO NEEDED TO DETECT AND RESPOND TO ANTIMICROBIAL DISEASE THREATS AT THE HUMAN-ANIMAL INTERFACE. TRACKING RESPIRATORY DISEASES IS A TOP PRIORITY IN NORTH CAROLINA. WE HAVE A VERY ROBUST SURVEILLANCE INFRASTRUCTURE CONSISTING OF OUR CASE-BASED REPORTING SYSTEM, NORTH CAROLINA ELECTRONIC DISEASE SURVEILLANCE SYSTEM (NC EDSS); OUR SYNDROMIC SURVEILLANCE SYSTEM, NORTH CAROLINA DISEASE EVENT TRACKING AND EPIDEMIOLOGIC COLLECTION TOOL (NC DETECT); THE NORTH CAROLINA WASTEWATER MONITORING NETWORK; AND THE LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS). SIGNIFICANT INVESTMENTS IN SURVEILLANCE AND PUBLIC DATA SHARING FOR INFLUENZA, RSV, AND COVID-19 HAVE TRANSLATED TO MORE INFORMED INDIVIDUAL RISK-BASED DECISION MAKING AND HAVE HELPED RAISE AWARENESS OF RACIAL AND ETHNIC DISPARITIES.

P01AI165072 · Department of Health and Human Services · National Institutes of Health · MA · award runs 2021-09-16 to 2025-08-31

DISCOVERING DURABLE PAN-CORONAVIRUS IMMUNITY - OVERALL SUMMARY SEVERE ACUTE RESPIRATORY SYNDROME (SARS) CORONAVIRUS (COV)-2 IS A DEVASTATING HUMAN THREAT. WHILE SUCCESSFUL VACCINE PROGRAMS ARE UNDERWAY, GENETIC DRIFT AND IMMUNE ESCAPE HAVE ALREADY BEGUN TO SUBVERT IMMUNITY, WITH MORE VARIANTS LIKELY TO CONTINUE TO EMERGE. MOREOVER, THE RATES OF ZOONOTIC COV TRANSMISSION HAVE INCREASED OVER THE PAST TWO DECADES—INDICATING THAT IT MAY NOT BE LONG BEFORE ANOTHER COV BREACHES HOST-SPECIES BARRIERS INTO HUMANS. NEXT GENERATION VACCINE DESIGN STRATEGIES THAT ARE ABLE TO PROVIDE ROBUST PROTECTION AGAINST EVOLVING SARS-COV-2 STRAINS IN ADDITION TO OTHER COVS ARE URGENTLY NEEDED. THE OVERALL GOAL OF THIS PROGRAM IS TO PRODUCE CRITICAL INFORMATION NECESSARY FOR THE DESIGN AND TESTING OF NEXT GENERATION VACCINE STRATEGIES THAT PROVIDE PROTECTIVE EFFICACY WITH THE GREATEST POSSIBLE BREADTH ACROSS THE COV FAMILY. THE OVERALL PROGRAM HYPOTHESIS IS THAT IMMUNOLOGICAL DISCERNMENT OF HETEROGENEITY IN HUMAN RESPONSES TO SARS-COV-2 INFECTION AND VACCINATION WILL ILLUMINATE FACTORS THAT CAN IMPACT EFFICACY AND BREADTH OF COV VACCINE STRATEGIES. THIS HYPOTHESIS IS SUPPORTED BY RECENT PUBLICATIONS AND PRELIMINARY DATA FROM OUR TEAM. IN THIS REGARD, ALTHOUGH HUNDREDS OF VACCINES ARE UNDER DEVELOPMENT, THE TARGETS MOST RELEVANT FOR PAN- COV IMMUNITY MAY DEFY THE SIMPLE NEED FOR THE INDUCTION OF NEUTRALIZING ANTIBODY RESPONSES, WHICH LARGELY BIND TO NON-CONSERVED AREAS IN THE S1 REGION OF THE VIRAL SPIKE (S) PROTEIN—SUSCEPTIBLE TO VIRAL ESCAPE. EMERGING EVIDENCE FROM OUR TEAM POINTS TO THE IMPORTANCE OF THE S2 REGION, WHICH IS MORE CONSERVED ACROSS COVS. OUR TEAM HAS FOUND THAT RAPID INDUCTION OF ANTI-S2 ANTIBODIES IS CONNECTED TO LESS DEATH IN SEVERE DISEASE, MORE CROSS-REACTIVE MEMORY B CELL RESPONSES, SWIFT HEALING IN MILD DISEASE, AND IMPROVED ANTIBODY DURABILITY AFTER DISEASE RESOLUTION. THE FACTORS UNDERLYING WHY SOME PEOPLE DEVELOP BETTER-CLINICAL-OUTCOME- ASSOCIATED CROSSREACTIVE ANTI-S2 IMMUNE RESPONSES REMAINS TO BE FULLY DEFINED. WE HAVE ASSEMBLED A MULTIDISCIPLINARY TEAM WITH EXPERTISE IN IMMUNOLOGY, VIROLOGY, GENETICS, MEDICINE, BIOCHEMISTRY, STRUCTURAL BIOLOGY AND MATHEMATICS TO ACHIEVE THE OVERALL PROGRAM GOAL. THE COMPLEMENTARY AND INTEGRATIVE EXPERTISE OF THE TEAM WILL COME TOGETHER TO: 1) FINELY MAP THE HUMORAL AND CELLULAR RESPONSES TO SARS-COV-2 VARIANTS AND CORONAVIRAL RELATIVES THAT EMERGE AFTER NATURAL INFECTION OR VACCINATION, 2) DEFINE THE MECHANISM(S) BY WHICH THESE RESPONSES CONFER PROTECTION, AND 3) UTILIZE THESE MECHANISTIC CORRELATES OF IMMUNITY TO INSPIRE CUTTING EDGE, STRUCTURALLY STABLE NATIVE-LIKE S ANTIGENS THAT WILL BE USED IN A STEP-WISE IMPROVEMENT APPROACH IN VACCINATION AND PROTECTION STUDIES. COLLECTIVELY, THE DATA GENERATED BY THIS TEAM WILL (A) IDENTIFY IMMUNOLOGICAL CORRELATES OF ANTI-COV BREADTH EXPECTED TO INFORM VACCINE DESIGN; (B) DEFINE THE MOST CONSERVED TARGETS ON COV S ACCESSIBLE TO THE HUMAN ADAPTIVE IMMUNE SYSTEM AND MECHANISTIC INSIGHTS INTO THEIR RECOGNITION; (C) GENERATE NOVEL IMMUNOGENS INCORPORATING B AND T CELL STRATEGIES INFORMED BY (A-C) ABOVE; AND (D) TEST THEM IN THE CONTEXT OF PROGRAM-OPTIMIZED DELIVERY METHODS TO MAXIMIZE BREADTH OF PROTECTIVE, DURABLE COV IMMUNITY.

NU51CK000339 · Department of Health and Human Services · Centers for Disease Control and Prevention · FL · award runs 2024-08-01 to 2029-07-31

FLORIDA'S RESPONSE TO THE NOTICE OF FUNDING OPPORTUNITY TO THE EPIDEMIOLOGY AND LABORATORY CAPACITY APPLICATION - FLORIDA IS A LARGE STATE GEOGRAPHICALLY AND IN POPULATION (21.54 MILLION IN 2022, WITH 134 MILLION VISITORS ANNUALLY, MANY OF WHOM ARE INTERNATIONAL. GIVEN THE STATE’S LARGE AND GLOBALLY MOBILE POPULATION AND THE NUMBER OF HEALTH CARE FACILITIES INVOLVED, EMERGING INFECTIONS PRESENT CHALLENGES FOR FLORIDA. THE ACTIVITIES PROPOSED IN THIS GRANT WILL STRENGTHEN COMMUNICATION AND COLLABORATION BETWEEN PUBLIC HEALTH AND MULTIPLE PARTNERS ACROSS THE SPECTRUM OF HEALTH CARE TO ADDRESS THE CHALLENGES PRESENTED IN DETECTING, RESPONDING, PREVENTING AND CONTROLLING HIGHLY INFECTIOUS DISEASES. CAPACITY SUSTAINED BY THIS EPIDEMIOLOGY AND LABORATORY CAPACITY FOR INFECTIOUS DISEASES (ELC) FUNDING OPPORTUNITY WILL HELP SUPPORT PROGRAM SPECIFIC COMPONENTS IN THE AREAS OF HEALTHCARE-ASSOCIATED INFECTIONS, ZOONOTIC, VECTOR BORNE, ANTIMICROBIAL RESISTANCE, AND FOOD AND WATERBORNE SURVEILLANCE. ELC FUNDS WILL INTEGRATE EPIDEMIOLOGY AND LABORATORY CAPACITY ACTIVITIES AND IMPROVE HEALTH INFORMATION SYSTEMS FOR TRACKING TRENDS IN KNOWN AND EMERGING INFECTIOUS DISEASES. TOGETHER THESE ACTIVITIES WILL SUPPORT AND ENHANCE EARLY DETECTION OF AND RAPID RESPONSE TO DISEASE OUTBREAKS, AS WELL AS EVALUATION OF PUBLIC HEALTH INTERVENTIONS.

NU50CK000628 · Department of Health and Human Services · Centers for Disease Control and Prevention · MN · award runs 2022-09-30 to 2027-09-29

MINNESOTA DEPARTMENT OF HEALTH PATHOGEN GENOMICS CENTER OF EXCELLENCE - THE MINNESOTA DEPARTMENT OF HEALTH (MDH) IS APPLYING TO BE PART OF THE PATHOGEN GENOMICS CENTER OF EXCELLENCE (PGCOE) NETWORK. MDH IS APPLYING FOR THE MANDATORY CORE AND RESPONSE PORTION, AND OPTIONAL EDUCATION PGCOE LEAD PORTION OF THIS FUNDING OPPORTUNITY. THE DEVELOPMENT OF ADVANCED MOLECULAR DETECTION (AMD) AT THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) AND STATE PUBLIC HEALTH LABORATORIES OVER THE YEARS ESTABLISHED A COMPREHENSIVE FOUNDATION FOR PUBLIC HEALTH INFECTIOUS PATHOGEN GENOMIC SURVEILLANCE. THE COVID-19 PANDEMIC AND ITS SHOCKWAVE REVEALED THE URGENT NEED TO FURTHER ADVANCE AMD INFRASTRUCTURE AND ORGANICALLY INTEGRATE GENOME DATA INTO ROUTINE PUBLIC HEALTH EPIDEMIOLOGY PRACTICE. IN ADDITION, THE PANDEMIC AMPLIFIED THE LONG-EXISTING DISPARITIES: HEALTH INEQUALITY IN RURAL AREA AND MINORITY POPULATION; ZOONOTIC DISEASE SURGE ROOTED FROM CLIMATE CHANGE; FOOD SAFETY AND INSECURITY DUE TO ANTIBIOTIC RESISTANCE AND PANDEMIC-DRIVEN PUBLIC HEALTH WORKFORCE SHORTAGES. THE PROJECTS OF OUR PGCOE PROPOSAL, WHICH IN COLLABORATION WITH OUR ACADEMIC PARTNERS, ARE INTENDED TO WORK TOWARDS THESE ISSUES. MDH’S PRIMARY ACADEMIC PARTNERS ARE THE UNIVERSITY OF MINNESOTA AND THE MAYO CLINIC, WHERE WE HAVE DEVELOPED PARTNERSHIPS WITH A TEAM OF WORLD-CLASS SCIENTISTS WHO WILL COLLABORATE WITH MDH TO CREATE AND APPLY NOVEL GENOMIC AND BIOINFORMATIC TOOLS TO MONITOR AND RESPOND TO A WIDE RANGE OF PUBLIC HEALTH THREATS. THE DIVERSE PROJECTS PRESENTED IN THIS APPLICATION SPAN FROM NEW ASSAY/WORKFLOW DEVELOPMENT TO RESPIRATORY PATHOGEN BURDEN IN RURAL AND UNDERSERVED COMMUNITY, TO ENVIRONMENTAL SURVEILLANCE OF PUBLIC HEALTH PATHOGENS, TO EARLY SENTINEL SURVEILLANCE TO MINIMIZE THE THREAT OF FOODBORNE DISEASE, AND FINALLY, TO UTILIZE EXISTING EDUCATIONAL INFRASTRUCTURE TO CULTURE FUTURE PUBLIC HEALTH GENOMIC LABORATORIANS AND EPIDEMIOLOGISTS. FUNDING IS REQUESTED FOR MDH STAFF AND SUPPLIES AS WELL AS FOR ACADEMIC COLLABORATORS TO CARRYOUT THE PROPOSED COLLABORATIVE PROJECTS. MDH WILL HAVE OVERSIGHT OVER PGCOE ACTIVITIES WITH AN EXTERNAL ADVISORY COMMITTEE THAT WILL ENSURE MEASURES OF EFFECTIVENESS ARE MET. WITH THE STATE-OF-THE-ART EXISTING INFRASTRUCTURE, PIONEER SCIENTISTS, LABORATORIANS, EPIDEMIOLOGIST FROM MDH AND ITS LONG-STANDING ACADEMIC COLLABORATORS, AS WELL AS DELIBERATELY PLANNED PROJECTS, MINNESOTA PGCOE WILL HAVE A STATE, REGIONAL, NATIONAL AND INTERNATIONAL IMPACT TO THE DAILY PRACTICE OF PUBLIC HEALTH IN THE PATHOGEN GENOMIC ERA.

NU51CK000340 · Department of Health and Human Services · Centers for Disease Control and Prevention · GA · award runs 2024-08-01 to 2029-07-31

THE EPIDEMIOLOGY AND LABORATORY CAPACITY FOR PREVENTION AND CONTROL OF EMERGING INFECTIOUS DISEASES (ELC) - THIS FUNDING OPPORTUNITY THROUGH THE EPIDEMIOLOGY AND LABORATORY CAPACITY FOR PREVENTION AND CONTROL OF EMERGING INFECTIOUS DISEASES (ELC) COOPERATIVE AGREEMENT CONTINUES TO SUPPORT THE GEORGIA DEPARTMENT OF PUBLIC HEALTH (GDPH) IN ITS COMMITMENT TO BUILD UPON PROGRAMS TO DIRECTLY ADDRESS EMERGING INFECTIOUS DISEASE THREATS. USING ELC FUNDS, THESE PROGRAMS CONTINUE TO ENHANCE THE CAPACITY OF OUR STATE’S PUBLIC HEALTH AGENCIES TO EFFECTIVELY DETECT, RESPOND, PREVENT AND CONTROL KNOWN AND EMERGING (AND RE-EMERGING) INFECTIOUS DISEASES. THIS WILL CONTINUE TO BE ACCOMPLISHED THROUGH THE APPLICATION OF THE FINANCIAL AND TECHNICAL RESOURCES PROVIDED BY THIS PROGRAM TOWARD STRENGTHENING EPIDEMIOLOGIC CAPACITY, ENHANCING LABORATORY CAPACITY, IMPROVING INFORMATION SYSTEMS INCLUDING PUBLIC HEALTH INFORMATICS GOALS OUTLINES IN CDC’S DATA MODERNIZATION INITIATIVE, AND ENHANCING COOPERATION AMONG EPIDEMIOLOGY, LABORATORY, AND INFORMATION SYSTEMS COMPONENTS OF PUBLIC HEALTH DEPARTMENTS. GDPH WILL FURTHER EXPAND ITS SCOPE OF ACTIVITIES FUNDED THROUGH ELC BY APPLYING FOR ADDITIONAL PROGRAMS AND PROJECTS OVER THIS NEXT FIVE-YEAR RENEWAL PERIOD. GDPH WILL PARTICIPATE IN ALL ACTIVITIES UNDER THE CROSS-CUTTING EMERGING INFECTIOUS DISEASE CAPACITY, SYSTEMS, AND LEADERSHIP SECTION (I). PREVIOUS SUPPLEMENTAL FUNDING THROUGH ELC DUE TO THE COVID PANDEMIC ENABLED GDPH TO DEVELOP ITS ADVANCED MOLECULAR DETECTION (AMD) PROGRAM AND A NATIONAL WASTEWATER SURVEILLANCE SYSTEM IN COLLABORATION WITH ITS LABORATORY. BOTH OF THESE ACTIVITIES WILL UNDERGO FURTHER DEVELOPMENT AS UNIQUE PROJECTS UNDER THIS NEW APPLICATION. GDPH WILL CONTINUE TO PARTICIPATE IN ALL EMERGING INFECTIOUS DISEASE PROGRAMS SUPPORTED UNDER ELC DIRECTED AGAINST FOODBORNE, WATERBORNE, ZOONOTIC, HEALTHCARE ASSOCIATED, ANTIMICROBIAL RESISTANT, VACCINE PREVENTABLE, RESPIRATORY, VECTOR-BORNE, AND TICK-ASSOCIATED DISEASES. NEW DISEASE-SPECIFIC PROJECTS THAT GDPH WILL SEEK FIRST TIME FUNDING FOR INCLUDE PRION SURVEILLANCE AND TO BECOME AN HIV CENTER FOR ENHANCED DETECTION OF HIV CLUSTERS AND OUTBREAKS. ELC SUPPORT WILL ENABLE GDPH WILL MAINTAIN ITS STRONG COLLABORATION BETWEEN EPIDEMIOLOGY, LABORATORY, AND HEALTH INFORMATION SYSTEM COMPONENTS, AS WELL AS WITH ELC PARTNERS, LOCAL HEALTH DEPARTMENTS, AND OTHER PARTNERS AND ORGANIZATIONS WITHIN THE JURISDICTION. HEALTH INFORMATION SYSTEMS (HIS) ARE EVER MORE CRITICAL CORE ASPECTS OF PUBLIC HEALTH FOR BOTH INTERNAL ADMINISTRATIVE AND PROGRAMMATIC UNITS AS WELL AS EXTERNAL PARTNERS. DATA COLLECTED IMPROVES SERVICE DELIVERY AND REPORTING WHICH LEADS TO MORE TIMELY AND ACCURATE DECISION MAKING. DATA ANALYTICS SUPPORTS DECISION MAKING, TRANSPARENCY, AND PROVIDES UNDERSTANDING. EFFORTS TO IDENTIFY AND ALLEVIATE HEALTH DISPARITIES AMONG SPECIFIC POPULATIONS IN GEORGIA WILL BE PARAMOUNT WHEN DESIGNING AND IMPLEMENTING PROGRAM ACTIVITIES AND ANALYZING DATA. GDPH WILL CONTINUE TO STRIVE FOR A MORE EFFECTIVE PUBLIC HEALTH WORKFORCE, IMPROVED USE OF DATA TO INFORM BEST PRACTICES, AND TO REDUCE MORBIDITY, MORTALITY, AND HEALTH DISPARITIES FROM INFECTIOUS DISEASES.

W9126G2220021 · Department of Defense · Department of the Army · HI · award runs 2022-09-15 to 2026-11-23

NATURAL RESOURCES AND THREATENED ENDANGERED SPECIES MANAGEMENT FOR THE ARMY NATURAL RESOURCES PROGRAM ON OAHU, US ARMY GARRISON HAWAII, OAHU, HAWAII

U01CK000564 · Department of Health and Human Services · Centers for Disease Control and Prevention · award runs 2019-09-01 to 2026-08-31

IDENTIFICATION, SURVEILLANCE, AND CONTROL OF VECTOR-BORNE AND ZOONOTIC INFECTIOUS DISEASES IN UGANDA

UC2AR082200 · Department of Health and Human Services · National Institutes of Health · TX · award runs 2022-09-23 to 2027-07-31

NEURONAL ANATOMY, CONNECTIVITY, AND PHENOTYPIC INNERVATION OF THE KNEE JOINT - PROJECT SUMMARY IDENTIFYING PATTERNS OF NEURONAL CONNECTIVITY IS CRITICAL FOR UNDERSTANDING FUNCTIONAL AND ANATOMICAL CIRCUITS THAT MEDIATE PAIN PERCEPTION. HOWEVER, KNOWLEDGE ABOUT THE TYPES AND DISTRIBUTION OF NEURONS IN JOINT TISSUES HAVE GENERALLY BEEN LIMITED TO TRADITIONAL 2-DIMENSION HISTOPATHOLOGICAL AND IMMUNOHISTOPATHOLOGICAL APPROACHES, AND LITTLE TO NO INFORMATION IS AVAILABLE ON CONNECTIVITY AND NEURONAL PHENOTYPES. NEW TECHNOLOGIES HAVE EMERGED THAT ALLOW FOR BOTH TRANS-SYNAPTIC CIRCUIT ANALYSIS AND PRECISE CONTROL OF NEURONAL FIRING, INCLUDING THE USE OF RETROGRADELY TRANSPORTED VIRAL VECTORS (I.E., PSEUDOTYPED RABIES VIRUS) AND HETEROLOGOUS RECEPTOR ACTIVATION. AT THE SAME TIME, 3-DIMENSIONAL VISUALIZATION OF NEURONAL AND VASCULAR PATTERNS HAVE BEEN ADVANCED BY TISSUE CLEARING TECHNIQUES IN CONJUNCTION WITH CELL TYPE SPECIFIC FLUORESCENT MARKERS GENERATED BY INTERCROSSING CELL TYPE SPECIFIC CRE RECOMBINASE MOUSE LINES WITH A VARIETY OF CONDITIONALLY ACTIVATED REPORTERS. FINALLY, THE ADVENT OF SINGLE CELL RNA SEQUENCING HAS ALLOWED FOR EXTENDING CELLULAR PHENOTYPING TO A MOLECULAR LEVEL THAT HAS NOT ONLY INCREASES ANALYTIC RESOLUTION, BUT ALSO THERAPEUTIC TARGETING WITH GREATER DISEASE SPECIFICITY THAN PREVIOUSLY POSSIBLE. THE DEVELOPMENT OF HIGH RESOLUTION SPATIAL TRANSCRIPTOMICS, I.E., MERFISH, ALLOWS FOR CORRELATION AND VALIDATION OF SCRNA-SEQ DATA. IN THIS CONTEXT, OSTEOARTHRITIS OF THE KNEE JOINT IS AN OPTIMAL MODEL FOR APPLYING THESE TOOLS AS ABUNDANT GENETIC AND SURGICAL MODELS ARE AVAILABLE FOR ORTHOGONAL VALIDATION OF FINDINGS. MOREOVER, IN THE PRECLINICAL CONTEXT, VARIOUS THERAPEUTIC APPROACHES INCLUDING GENE THERAPY HAVE BEEN SHOWN TO IMPACT PAIN MEASURES, AND AS SUCH, THEY CONSTITUTE AN IMPORTANT INTERVENTIONAL VALIDATION OF MOLECULAR CHANGES THAT ARE IDENTIFIED IN NEURONS IN THE DISEASE STATE. THE FACT THAT SOME OF THESE THERAPIES ARE NOW IN CLINICAL TRIAL ADDS TO THE POTENTIAL TRANSLATIONAL IMPACT OF THE PROPOSED PRECLINICAL FINDINGS HERE. ULTIMATELY, THE COMBINATION OF BOTH ANATOMIC, 3-D, AND MOLECULAR SIGNATURES WILL FACILITATE THE TRANSLATION INTO HUMAN TISSUES AND BIOPSIES, WHILE MAXIMIZING THE LIKELIHOOD OF RELEVANT NEW THERAPEUTIC TARGETS.

P20GM130448 · Department of Health and Human Services · National Institutes of Health · KS · award runs 2020-06-01 to 2031-04-30

CENTER ON EMERGING AND ZOONOTIC INFECTIOUS DISEASES

F25AF01494 · Department of the Interior · U.S. Fish and Wildlife Service · FL · award runs 2025-07-01 to 2026-06-30

CURRENTLY THE FLORIDA WILDLIFE MANAGEMENT AREA (WMA) SYSTEM CONSISTS OF OVER 150 TRACTS AND 6 MILLION ACRES. THIS WILDLIFE RESTORATION GRANT PROJECT INCLUDES 84 WMAS AND 4.55 MILLION ACRES. THIS PROJECT WILL RESTORE AND MAINTAIN OR ENHANCE THE HABITAT FOR WILDLIFE AND ASSIST IN PROVIDING PUBLIC ACCESS TO THE WMAS OF FLORIDA. PROJECT ACTIVITIES INCLUDE THE DEVELOPMENT AND MAINTENANCE OF WMAS IN FLORIDA. THE FLORIDA WMAS PROVIDE A VARIETY OF RECREATIONAL OPPORTUNITIES SUCH AS HUNTING AND FISHING OR WILDLIFE VIEWING. THESE NATURAL AREAS ALSO PROVIDE VALUE BY MAINTAINING ENDANGEREDSPECIES AND PRESERVING WETLANDS AS WELL AS PROVIDING A STABLE ECOSYSTEM. AS THE FLORIDA LANDSCAPE BECOMES SUBJECT TO MORE GROWTH AND DEVELOPMENT THE FUTURE OF MANY WILDLIFE SPECIES WILL REST WITH HOW SUCCESSFUL WE ARE AS LAND MANAGERS AND STEWARDS OF THE RESOURCES. IT IS IMPERATIVE THAT SOUND MANAGEMENT PRACTICES ARE IMPLEMENTED ON THESE CONSERVATION LANDS TO PROTECT THE NATURAL RESOURCES AND BALANCE RECREATIONAL OPPORTUNITIES.

P01AI168347 · Department of Health and Human Services · National Institutes of Health · MO · award runs 2022-09-02 to 2027-08-31

THE DEVELOPMENT AND EVALUATION OF PAN-CORONAVIRUS VACCINES - OVERALL SUMMARY GIVEN THE HISTORICAL OUTBREAKS OF CORONAVIRUSES, COUPLED WITH THE RECENT EMERGENCE OF SARS- COV-2 AND THE DESTABILIZING CONSEQUENCE OF COVID-19 ON GLOBAL HEALTH AND ECONOMY, THERE IS AN URGENT AND CRITICAL NEED TO DEVELOP NEW VACCINES CAPABLE OF BROAD PROTECTION AGAINST EXISTING AND FUTURE SARBECOVIRUSES AND MERBECOVIRUSES. THIS P01 PROGRAM PROJECT (PPG) ADDRESSES THE HYPOTHESIS THAT A COMBINATION OF EVOLUTIONARILY-DESIGNED AND OPTIMIZED B AND T CELL ANTIGENS CAN CONFER BROAD AND PROTECTIVE IMMUNITY AGAINST SARBECOVIRUSES AND MERBECOVIRUSES THAT CURRENTLY EXIST OR COULD EMERGE FROM ZOONOTIC RESERVOIRS. THE PPG INTEGRATES THE WORK OF ELEVEN LEADING LABORATORIES WITH RECORDS OF COLLABORATION THAT HAVE EXPERTISE IN CORONAVIRUS BIOLOGY, VIRAL PATHOGENESIS, B AND T CELL IMMUNITY, VACCINE DEVELOPMENT, ANIMAL CHALLENGE STUDIES, STRUCTURAL BIOLOGY, ANTIBODY STRUCTURE AND FUNCTION, ANTIGEN DESIGN, AND EVOLUTIONARY ANALYSIS OF VIRUSES. ALL PROJECTS AND CORES PLAN INTERACTIVE STUDIES WITH THE FOCUSED GOAL OF DESIGNING OPTIMIZED B AND T CELL ANTIGENS FOR INCORPORATION IN ADENOVIRAL (CHAD) AND VESICULAR STOMATITIS VIRUS (VSV) VECTORS TO CREATE MUCOSAL AND SYSTEMIC VACCINES THAT PROTECT AGAINST INFECTION AND DISEASE CAUSED BY A RANGE OF CORONAVIRUSES OF POTENTIAL CONCERN. THE PPG IS SERVED BY A CENTRAL ANIMAL CHALLENGE CORE THAT PERFORMS VACCINATION AND INFECTION EXPERIMENTS IN MICE AND HAMSTERS AND A CENTRAL ADMINISTRATIVE CORE THAT STREAMLINES DATA MANAGEMENT AND SHARING, PROVIDES COMPUTATIONAL ANALYSIS FOR DOWN-SELECTION AND SCIENTIFIC DECISION-MAKING, AND FACILITATES COMMUNICATION. OUR PROPOSAL AND ANTIGEN DESIGN PROGRAM SERVES AS A BLUEPRINT FOR POSSIBLE PRODUCT DEVELOPMENT WITH CHAD VACCINES, VSV-BASED VACCINES, OR EVEN WITH OTHER PLATFORMS (E.G., MRNA VACCINES, NANOPARTICLES, ETC.) NOT DIRECTLY EVALUATED HERE. BY THE CONCLUSION OF OUR PPG, WE ENVISION GENERATING AT LEAST ONE AND LIKELY MULTIPLE VIRAL- VECTORED VACCINE PLATFORMS THAT INDUCE BROAD SPECTRUM IMMUNITY TO MULTIPLE CORONAVIRUSES OF CONCERN INCLUDING HUMAN AND ZOONOTIC SARBECOVIRUSES AND MERBECOVIRUSES THAT COULD EMERGE IN THE FUTURE.

U01FD007857 · Department of Health and Human Services · Food and Drug Administration · NC · award runs 2023-09-01 to 2027-02-28

RESEARCH TRIANGLE CENTER OF EXCELLENCE IN REGULATORY SCIENCE AND INNOVATION - ABSTRACT THE RAPID EMERGENCE OF INNOVATIVE TECHNOLOGIES, THERAPEUTICS, AND OTHER FDA-REGULATED PRODUCTS HAVE OUTPACED THE ABILITY TO EFFECTIVELY APPROPRIATE THEM FOR PUBLIC BENEFIT. DOING SO HINGES ON THE CAPABILITY TO EXPEDITIOUSLY EVALUATE THESE PRODUCTS AND EFFECTIVELY MONITOR THEM ONCE ON THE MARKET. HOWEVER, METHODOLOGIES FOR PRE- MARKET EVALUATION THROUGH LABORATORY TESTING AND CLINICAL TRIALS FOR DRUGS, DEVICES, AND BIOLOGICS AND FOR POST- MARKETING SURVEILLANCE OF ALL FDA-REGULATED PRODUCTS HAVE NOT KEPT PACE, AND KEY GAPS IN KNOWLEDGE EXIST THAT WOULD INFORM REGULATORY DECISION MAKING IN MANY AREAS. IN THE FACE OF THESE PRESSING NEEDS, THE RESEARCH TRIANGLE CENTER OF EXCELLENCE IN REGULATORY SCIENCE AND INNOVATION (TRIANGLE CERSI) WILL PROVIDE A ONE-STOP- SHOP ACCELERATOR TO MEET FDA’S CURRENT AND EVOLVING NEEDS IN REGULATORY SCIENCE AND A GENERATIVE COMMUNITY FOR REGULATORS, ACADEMIA, INDUSTRY, AND OTHER STAKEHOLDERS. A COLLABORATION OF THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL, DUKE UNIVERSITY, NORTH CAROLINA STATE UNIVERSITY, AND NORTH CAROLINA CENTRAL UNIVERSITY, ALL IN CLOSE PROXIMITY, THE TRIANGLE CERSI REPRESENTS A BROAD NETWORK OF INVESTIGATORS AND NATIONAL AND INTERNATIONAL COLLABORATORS THAT BRING UNIQUE AND DIVERSE EXPERTISE AND RESOURCES FOR REGULATORY SCIENCE, INCLUDING BUT NOT LIMITED TO NOVEL APPROACHES IN STATISTICAL METHODOLOGIES, MACHINE LEARNING AND ARTIFICIAL INTELLIGENCE, IMAGING, IN SILICO TRIALS, PEDIATRIC PHARMACOLOGY, PATIENT REPORTED OUTCOMES (PRO), POPULATION SCIENCE, AND SAFETY ASSESSMENT ACROSS THE LIFESPAN, AND OTHER AREAS. THE TRIANGLE CERSI INCLUDES TWO SCHOOLS OF MEDICINE, A SCHOOL OF PHARMACY, TWO SCHOOLS OF NURSING, A SCHOOL OF PUBLIC HEALTH, A COLLEGE OF VETERINARY MEDICINE, A LEADING HISTORICALLY BLACK UNIVERSITY, A NATIONAL CENTER FOR VIRTUAL IMAGING TRIALS, AND THE DUKE CLINICAL RESEARCH INSTITUTE, AND LEVERAGES RELATIONSHIPS WITH NEARBY COMPANIES AND ORGANIZATIONS IN THE RESEARCH TRIANGLE PARK. THE TRIANGLE CERSI HAS THREE SPECIFIC AIMS: 1. CONDUCT REGULATORY SCIENCE PROJECTS IN COLLABORATION WITH FDA TO DELIVER MAJOR ADVANCES IN REGULATORY SCIENCE AND RAPIDLY ADDRESS A BROAD RANGE OF MAJOR, SPECIFIC, AND EMERGING CHALLENGES IN RESPONSE TO FDA NEEDS. 2. ESTABLISH ROBUST CERSI CORE INFRASTRUCTURE TO DEVELOP, PROPOSE, SUPPORT, ENABLE, AND MONITOR EXECUTION OF CERSI RESEARCH PROJECTS TO FACILITATE RAPID ACHIEVEMENT OF PROJECT DELIVERABLES; PARTNER OAK RIDGE NATIONAL LABORATORY PROVIDES SUPPORT FOR DATA ACCESS, COMPUTATION, AND RESOURCE SHARING. 3. EXPAND SUPPORT OF THE TRIANGLE CERSI AND EXTEND ITS IMPACT THROUGH REGULATORY SCIENCE INFORMATION SHARING ACTIVITIES, INCLUDING EFFORTS TO DIVERSIFY THE REGULATORY SCIENCE WORKFORCE. THE TRIANGLE CERSI WILL ACTIVELY SHARE RESULTS AND NEWLY DEVELOPED TOOLS AND RESOURCES WITH THE FDA, RESEARCH COMMUNITY, STAKEHOLDERS, AND OUR INSTITUTIONS’ STUDENTS AND TRAINEES. TOGETHER, OUR OVERARCHING GOAL IS TO PROVIDE AN ABUNDANCE OF ESSENTIAL NEW INFORMATION, INFRASTRUCTURE, AND TOOLS TO SHORTEN THE DRUG AND DEVICE DEVELOPMENT PROCESS, TO ADVANCE PUBLIC HEALTH, AND TO INFORM FDA ACTIVITIES IN WAYS THAT COMPLEMENT OTHER CERSIS AND CONTRIBUTE TO ACHIEVING THE GOALS OF THE NATIONAL CERSI PROGRAM.

NU51CK000346 · Department of Health and Human Services · Centers for Disease Control and Prevention · NM · award runs 2024-08-01 to 2029-07-31

EPIDEMIOLOGY & LABORATORY CAPACITY FOR PREVENTION & CONTROL OF EMERGING INFECTIONS (ELC) - NEW MEXICO (NM) HAS A DIVERSE POPULATION OF 2,117,292 ACCORDING TO NM’S INDICATOR-BASED INFORMATION SYSTEM (NM-IBIS) 2020 ESTIMATES. AMERICAN INDIAN AND ALASKA NATIVES MAKE UP 9% OF THE POPULATION AND 50% OF THE POPULATION ARE PERSONS OF HISPANIC OR LATINO ORIGIN. NEW MEXICO IS A GEOGRAPHICALLY LARGE, PREDOMINATELY RURAL AND FRONTIER “MAJORITY-MINORITY” STATE THAT SHARES A BORDER WITH MEXICO. NEW MEXICO HAS A CENTRALIZED DEPARTMENT OF HEALTH (NMDOH) WITHOUT LOCAL HEALTH OFFICES. THE EPIDEMIOLOGY AND LABORATORY CAPACITY (ELC) GRANT FUNDS PUBLIC HEALTH ACTION THROUGHOUT THE STATE. THE MAIN ELC BENEFICIARIES AT NMDOH ARE THE EPIDEMIOLOGY AND RESPONSE DIVISION, THE SCIENTIFIC LABORATORY DIVISION (SLD, STATE PUBLIC HEALTH LABORATORY) AND TO A LESSER DEGREE THE PUBLIC HEALTH DIVISION (PHD, STAFFS LOCAL PUBLIC HEALTH OFFICES/CLINICS). THE NEW MEXICO DEPARTMENT OF HEALTH PROPOSES TO CONDUCT ACTIVITIES IN THE FOLLOWING AREAS: SECTION I: CROSS-CUTTING EMERGING INFECTIOUS DISEASE CAPACITY, SYSTEMS, AND LEADERSHIP PROGRAM A: CROSS-CUTTING EPIDEMIOLOGY AND LABORATORY CAPACITY PROJECT B: ELC LEADERSHIP, MANAGEMENT, AND ADMINISTRATION PROJECT C: HEALTH INFORMATION SYSTEM (HIS) CAPACITY PROJECT D: ADVANCED MOLECULAR DETECTION (AMD) PROJECT E: NATIONAL WASTEWATER SURVEILLANCE SYSTEM PROJECT F: EMERGING ISSUES SECTION II: EMERGING INFECTIOUS DISEASE PROGRAMS PROGRAM G: ENTERIC, FOODBORNE, WATERBORNE, AND ZOONOTIC DISEASES: SURVEILLANCE, DETECTION, RESPONSE, REPORTING, AND PREVENTION PROGRAM H: HEALTHCARE-ASSOCIATED INFECTIONS, ANTIMICROBIAL RESISTANCE, AND ANTIBIOTIC STEWARDSHIP PROGRAM I: ANTIMICROBIAL RESISTANCE LABORATORY NETWORK (AR LAB NETWORK) PROGRAM J: ENHANCED SURVEILLANCE FOR VACCINE-PREVENTABLE DISEASE (VPD) AND RESPIRATORY DISEASES PROGRAM K: VECTOR-BORNE DISEASES AND TICK-ASSOCIATED CONDITIONS SECTION III: DISEASE-SPECIFIC PROJECTS PROJECT M: MYCOTICS: DETECTING AND PREVENTING FUNGAL INFECTIONS PROJECT N: BINATIONAL BORDER INFECTIOUS DISEASE SURVEILLANCE (BIDS) PROJECT Q: COMBATING ANTIMICROBIAL RESISTANT GONORRHEA AND OTHER STIS (CARGOS) PROJECT R: RABIES SURVEILLANCE AND LABORATORY CAPACITY PROGRAM FUNDING WILL BE SPENT IN ACCORDANCE WITH THE GRANT GUIDANCE. PROJECT-SPECIFIC PERFORMANCE MEASURES ARE PROPOSED TO MONITOR GRANT-RELATED ACTIVITIES.

NU51CK000360 · Department of Health and Human Services · Centers for Disease Control and Prevention · OR · award runs 2024-08-01 to 2029-07-31

OREGON APPLICATION FOR EPIDEMIOLOGY AND LABORATORY CAPACITY FOR PREVENTION AND CONTROL OF EMERGING INFECTIOUSDISEASES - THE PURPOSE OF THIS FUNDING IS TO PROTECT THE HEALTH AND SAFETY OF THE AMERICAN PEOPLE, AND IN PARTICULAR PEOPLE IN OREGON, BY ENHANCING THE ABILITY OF OREGON HEALTH AUTHORITY (OHA) AND ITS PARTNERS TO EFFECTIVELY PREVENT, DETECT, AND RESPOND TO EMERGING INFECTIOUS DISEASE THREATS. THROUGH THIS APPLICATION, OHA PROPOSES TO MAINTAIN CAPACITY TO IMPROVE INFECTIOUS DISEASE SURVEILLANCE SYSTEMS AND OUTBREAK RESPONSE AS WELL AS PROVIDE TRAINING TO LOCAL PUBLIC HEALTH AUTHORITIES (LPHAS) IN THESE AREAS. SECONDLY, WE PROPOSE TO IMPROVE LABORATORY CAPACITY THROUGH CONTINUED COLLABORATION WITH LPHAS TO ENHANCE THE TIMELY RECEIPT OF SPECIMENS, TESTING, AND RESULTS REPORTING WHILE MAINTAINING CORE INSTRUMENTATION TO ASSURE OPERATIONAL READINESS AND RESPONSE. THIRDLY, WE PROPOSE TO MAINTAIN CAPACITY TO IMPROVE HEALTH INFORMATION SYSTEMS BY ADVANCING STANDARDS-BASED ELECTRONIC DATA EXCHANGE, INCREASING INFORMATION SYSTEMS INTEROPERABILITY, AND SUSTAINING AND ENHANCING INTEGRATED SURVEILLANCE INFORMATION SYSTEMS. WITHIN THIS APPLICATION, OHA PROPOSES TO AUGMENT OUR CURRENT CAPACITY THROUGH THE ADDITION OF PROJECTS ENHANCING GENOMIC SURVEILLANCE (PROJECT D), WASTEWATER SURVEILLANCE (PROJECT E), VACCINE-PREVENTABLE DISEASE SURVEILLANCE AND RESPONSE (PROJECT J), GONORRHEA SURVEILLANCE (PROJECT Q), AND RABIES SURVEILLANCE (PROJECT R). OREGON WILL LEVERAGE THIS FUNDING OPPORTUNITY TO BUILD UPON THE ENHANCEMENT ACHIEVED DURING THE COVID-19 PUBLIC HEALTH EMERGENCY WHILE REFOCUSING OUR ATTENTION ON URGENT COMMUNICABLE DISEASE THREATS, INCLUDING HEALTHCARE-ASSOCIATED INFECTIONS SUCH AS CANDIDA AURIS, ANTIBIOTIC-RESISTANT SHIGELLOSIS CLUSTERS, AND HIGHLY PATHOGENIC AVIAN INFLUENZA MONITORING.

NU51CK000355 · Department of Health and Human Services · Centers for Disease Control and Prevention · PA · award runs 2024-08-01 to 2027-07-31

PHILADELPHIA EPIDEMIOLOGY AND LABORATORY CAPACITY FOR PREVENTION AND CONTROL OF EMERGING INFECTIOUS DISEASES (ELC) APPLICATION - THE PHILADELPHIA DEPARTMENT OF PUBLIC HEALTH (PDPH) SERVES AND PREVENTS DISEASE AMONG A DIVERSE URBAN POPULATION OF 1.6 MILLION RESIDENTS, INCLUDING MANY VULNERABLE PERSONS (E.G., >4,725 RESIDENTS EXPERIENCING HOMELESSNESS, 21.7% LIVING UNDER THE POVERTY LEVEL, 6.8% WITHOUT INSURANCE, 47.0% WITH PUBLIC INSURANCE). PHILADELPHIA IS THE 6TH MOST POPULATED CITY IN THE UNITED STATES (US) AND HAS BEEN IDENTIFIED AS THE POOREST LARGE CITY IN THE US. THE CITY’S POPULATION IS VERY DIVERSE BOTH ETHNICALLY AND SOCIALLY WITH EXTENSIVE GLOBAL AND DOMESTIC TRAVEL THROUGH INTERSTATE HIGHWAYS, MAJOR RAILWAY SYSTEMS, AND AN INTERNATIONAL AIRPORT THAT SERVED 28.1 MILLION TRAVELERS IN 2023 AND HOUSES A CDC QUARANTINE STATION. POVERTY AND ACCESS TO HEALTH SERVICES ARE GREAT CHALLENGES TO MANY PHILADELPHIA RESIDENTS AND IMMIGRANTS. THERE ARE LARGE POPULATIONS OF PEOPLE EXPERIENCING HOMELESSNESS IN PHILADELPHIA, THOSE WHO ARE INCARCERATED AND PERSONS WHO ACTIVELY USE DRUGS. THE CITY HAS A LARGE AND ACTIVE LGBTQ COMMUNITY AND IS THE EPICENTER FOR THE REGION REGARDING SOCIAL INTERACTIONS, DISEASE TRANSMISSION, AND ACCESS TO SPECIALTY HEALTH SERVICES. IN ADDITION TO THE COVID-19 PANDEMIC, PDPH HAS NEEDED TO EXECUTE SEVERAL LARGE AND VARYING RESPONSES WITH NOTABLY LARGER NUMBERS OF CASES OR EXPOSED PERSONS IN RECENT YEARS (E.G., INCREASES IN HEPATITIS A AMONG AT-RISK ADULTS, ENDEMIC TRANSMISSION OF MPOX, SHIGELLA AMONG AT-RISK ADULTS, MEASLES OUTBREAK, ETC.). AS DEMONSTRATED DURING THESE RESPONSES, CROSS-CUTTING APPROACHES AMONG EPIDEMIOLOGY, LABORATORY, AND HEALTH INFORMATION SYSTEMS ALONG WITH PLANNING FOR RESPONSE ACTIVITIES AND SURGE SUPPORT ARE ESSENTIAL. MOREOVER, THESE RESPONSES HAVE HIGHLIGHTED THE NEED FOR DIRECTING ADDITIONAL RESOURCES AND EFFORTS TO REACH THE CITY’S MOST VULNERABLE RESIDENTS. WITH LOWER COVID-19 ACTIVITY DUE TO MEDICAL COUNTERMEASURES, PDPH STAFF HAVE BEGUN TO INTEGRATE COVID-19 SURVEILLANCE AND RESPONSE ACTIVITIES INTO ROUTINE SURVEILLANCE AND HEALTHCARE-ASSOCIATED INFECTION ACTIVITIES ALONG WITH THE RESUMPTION OF PREVENTION ACTIVITIES FOR COMMON COMMUNICABLE DISEASES. THE OPIOID EPIDEMIC CONTINUES TO PRESENT ONGOING CHALLENGES AND HAS CONTRIBUTED TO LARGE OUTBREAKS OF HEPATITIS A, SHIGELLA, AND INVASIVE GROUP A STREPTOCOCCAL INFECTIONS AMONG PERSONS WHO USE DRUGS IN PHILADELPHIA AND/OR ARE EXPERIENCING HOMELESSNESS. PDPH ALSO CONTINUES TO MONITOR FOR POTENTIAL IMPORTATIONS OF EMERGING AND PREVIOUSLY ELIMINATED INFECTIONS (E.G., VIRAL HEMORRHAGIC FEVERS, MEASLES, MALARIA, TRAVEL-ASSOCIATED ARBOVIRUSES, NOVEL INFLUENZA A, ETC.) IN THE CITY AND CONTINUES TO IMMEDIATELY RESPOND TO PATIENTS SUSPECTED TO HAVE INFECTION DUE TO A HIGH CONSEQUENCE PATHOGEN (E.G., VIRAL HEMORRHAGIC FEVERS, HUMAN RABIES). THE PDPH HEALTHCARE-ASSOCIATED INFECTIONS AND ANTIBIOTIC RESISTANCE PROGRAM INVESTIGATES, RESPONDS, PROMOTES ANTIBIOTIC STEWARDSHIP, AND CONDUCTS ONSITE INSPECTIONS TO CONTROL THE SPREAD OF EMERGING MULTIDRUG-RESISTANT ORGANISMS (E.G., CRE, CRPA, CRAB, CANDIDA AURIS) IN HEALTHCARE SETTINGS INCLUDING 47 LICENSED SKILL-NURSING FACILITIES. ELC FUNDING HAS GREATLY IMPROVED THE PDPH PUBLIC HEALTH LABORATORY’S INFRASTRUCTURE, WHICH HAS ALLOWED FOR THE IMPLEMENTATION OF MORE ADVANCED AND EFFICIENT TESTING METHODS (E.G., WHOLE GENOME SEQUENCING). DURING THE NEW FUNDING CYCLE, EFFORTS WILL BE MADE TO EXPAND USE OF THIS LABORATORY TECHNOLOGY BEYOND COVID-19. THE 2024-2029 ELC COOPERATIVE AGREEMENT FUNDING OPPORTUNITY GIVES PDPH THE MEANS TO CONTINUE AND IMPROVE ESSENTIAL PUBLIC HEALTH SERVICES BY ENHANCING DISEASE CONTROL PROGRAMS, IMPROVING ELECTRONIC LABORATORY REPORTING AND INFORMATICS INFRASTRUCTURE, EXPANDING DIAGNOSTIC TESTING CAPACITY, ACTIVATING RESPONSE ACTIVITIES, AND ESTABLISHING BETTER COLLABORATION AND OVERSIGHT OF ELC ACTIVITIES. THIS FUNDING IS CRITICAL TO PROTECT THE PUBLIC EQUITABLY AS OTHER INFECTIOUS DISEASE ACTIVITY RETURNS TO PRE‐PANDEMIC LEVELS AND NEW CONCERNS RELATED TO EMERGING/RE-EMERGING INFECTIONS ARISE.