2023-11-13T10:57:54-06:00 2022-12-31 440160260 FORVIS LLP 901 EAST CARY STREET SUITE 1000 RICHMOND VA 23219 990 2022-01-01 521986675 FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH INC FOUN 3014025311 11400 ROCKVILLE PIKE 600 NORTH BETHESDA MD 20852 DR JULIE L GERBERDING CHIEF EXECUTIVE OFFICER 3014025311 2023-11-09 1 DR JULIE L GERBERDING 999009999 1 LAKRISHA J CASTLEBERRY P01677333 8042827636 2023-11-09 2 AAL1 IAL1 2022 2023-04-26 12:10:37Z DONALD M HILL 11400 ROCKVILLE PIKE 600 NORTH BETHESDA MD 20852 209200907 0 X HTTP://WWW.FNIH.ORG X 1996 MD THE FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH (FNIH) CONNECTS THE WORLD'S LEADING PUBLIC AND PRIVATE ORGANIZATIONS TO ACCELERATE BIOMEDICAL BREAKTHROUGHS FOR PATIENTS, REGARDLESS OF WHO THEY ARE, WHERE THEY LIVE, OR WHAT DISEASE THEY HAVE. TOGETHER WITH LEADING SCIENTISTS AND PROBLEM-SOLVERS, AND A SUCCESSFUL TRACK RECORD OF NAVIGATING COMPLEX PROBLEMS, THE FNIH ACCELERATES NEW THERAPIES, DIAGNOSTICS, AND POTENTIAL CURES; ADVANCES GLOBAL HEALTH AND EQUITY IN CARE; AND CELEBRATES AND TRAINS THE NEXT GENERATION OF SCIENTISTS. ESTABLISHED BY CONGRESS IN 1990 TO SUPPORT THE MISSION OF THE NATIONAL INSTITUTES OF HEALTH (NIH), THE FNIH IS A NOT-FOR-PROFIT 501(C)(3) CHARITABLE ORGANIZATION. FOR MORE INFORMATION ABOUT THE FNIH, PLEASE VISIT FNIH.ORG. 25 24 90 24 0 0 105993785 68998263 50000 50000 1523894 1459757 38012 77179 107605691 70585199 20925571 32121575 0 0 11200771 12734826 0 0 142183 26276294 32561709 58402636 77418110 49203055 -6832911 221939759 216582542 10990437 18255107 210949322 198327435 X SEE SCHEDULE O, STATEMENT OF ORGANIZATION'S PRIMARY EXEMPT PURPOSE STATEMENTTO CREATE AND LEAD ALLIANCES AND PUBLIC-PRIVATE PARTNERSHIPS THAT ADVANCE BREAKTHROUGH BIOMEDICAL DISCOVERIES AND IMPROVE THE QUALITY OF PEOPLE'S LIVES 0 0 69214470 31578039 50000 SEE SCHEDULE O, PROGRAM ONE, RESEARCH PROGRAMSPROGRAM ONE - RESEARCH PROGRAMS -ACCELERATING MEDICINES PARTNERSHIP PROGRAM (AMP) THE FNIH MANAGES THE ACCELERATING MEDICINES PARTNERSHIP (AMP) PROGRAM WITH THE INTERESTS OF THE COLLECTIVE SCIENTIFIC AND MEDICAL RESEARCH COMMUNITIES IN MIND. OUR MISSION IS TO IMPROVE UNDERSTANDING OF DISEASE PATHWAYS, FACILITATE BETTER SELECTION OF TARGETS FOR TREATMENT, AND IDENTIFY PLATFORMS AND PROCESSES TO ACCELERATE NEW AND EFFECTIVE THERAPIES TO PATIENTS.ALL AMP PROJECTS OPERATE UNDER THE BROAD PRINCIPLE OF DELIVERING PRE-COMPETITIVE ADVANCEMENTS TO THE RESEARCH AND MEDICAL FIELDS AND ENABLING THE BROADEST POSSIBLE ACCESS AND USE OF AMP RESEARCH DISCOVERIES. A CRITICAL COMPONENT OF EACH PUBLIC-PRIVATE PARTNERSHIP IN THE AMP PROGRAM IS AN AGREEMENT AMONG PARTNERS TO MAKE DATA AND ANALYSES ARISING FROM THE COLLABORATION PUBLICLY ACCESSIBLE TO BENEFIT THE BROADER BIOMEDICAL COMMUNITY. INDIVIDUAL AMP PROJECTS FREQUENTLY ESTABLISH PUBLIC PORTALS TO RAPIDLY DISSEMINATE DATA FROM THEIR RESEARCH EFFORTS, AND AMP-FUNDED PUBLICATIONS ARE REQUIRED TO BE MADE AVAILABLE PUBLICLY WITHIN SPECIFIC TIMEFRAMES.AT THE CENTER OF THE AMP PROGRAM IS A COMMON GOAL OF ACCELERATING NEW AND EFFECTIVE THERAPIES TO PATIENTS. AMP PROJECTS WORK TOWARDS THIS GOAL BY IDENTIFYING CLINICALLY RELEVANT DISEASE TARGETS, IMPROVING IDENTIFICATION OF PATIENTS MOST LIKELY TO RESPOND TO A PARTICULAR TREATMENT, AND SAFELY REDUCING THE DEVELOPMENT TIMELINES FOR LIFE-SAVING THERAPIES AND IMPROVEMENTS IN PATIENT OUTCOMES.ACTIV IN MARCH 2020, AS THE RAPIDLY DEVELOPING THREAT OF THE COVID-19 PANDEMIC BECAME CLEARER, OFFICIALS OF THE NIH AND THE FNIH SPEEDILY ASSEMBLED A GOVERNMENT-INDUSTRY-ACADEMIA COALITION TO COORDINATE RESEARCH AND CLINICAL TESTING EFFORTS TO COUNTER THE VIRUS. THE RESULTING PARTNERSHIP IS CALLED ACTIV (ACCELERATING COVID-19 THERAPEUTIC INTERVENTIONS AND VACCINES) AND INCLUDES EIGHT U.S. GOVERNMENT AGENCIES, 20 BIOPHARMACEUTICAL COMPANIES, AND SEVERAL NONPROFIT ORGANIZATIONS, WITH THE MISSION OF DEVELOPING A RESEARCH STRATEGY FOR PRIORITIZING AND SPEEDING DEVELOPMENT OF THE MOST PROMISING COVID-19 VACCINES AND THERAPEUTICS.ACTIV REPLACED A PLETHORA OF SMALL INDIVIDUAL TRIALSMANY TOO SMALL OR INADEQUATELY DESIGNED TO PRODUCE MEANINGFUL RESULTSWITH A NATIONAL RESEARCH AGENDA FOR DEVELOPING THERAPEUTIC COUNTERMEASURES TO THE PANDEMIC AND PROVIDED SUPPORT FOR VACCINE DEVELOPMENT EFFORTS. ACTIV STANDS AS A MODEL FOR HOW THE BIOMEDICAL RESEARCH COMMUNITY CAN BE EFFECTIVELY MOBILIZED IN RESPONSE TO A GLOBAL PUBLIC HEALTH CRISIS.BIOMARKERS CONSORTIUM THE BIOMARKERS CONSORTIUM CONVENES GOVERNMENT, INDUSTRY, PATIENTS AND PATIENT ADVOCACY GROUPS, AND NOT-FOR-PROFIT ORGANIZATIONS TO ADDRESS ONE OF THE MOST PRESSING NEEDS IN THE DIAGNOSIS AND TREATMENT OF DISEASE: THE DEVELOPMENT AND THE SEEKING OF REGULATORY APPROVAL FOR DISEASE BIOMARKERS AND SURROGATES. THE BIOMARKERS CONSORTIUM CREATES AND LEADS CROSS-SECTOR EFFORTS THAT VALIDATE AND QUALIFY BIOMARKERS AND OTHER DRUG DEVELOPMENT TOOLS TO ACCELERATE BETTER DECISION MAKING FOR THE DEVELOPMENT OF NEW THERAPEUTICS AND HEALTH TECHNOLOGIES.THE CORE OPERATIONS OF THE BIOMARKERS CONSORTIUM ARE SUPPORTED THROUGH CONTRIBUTING MEMBERSHIP. ORGANIZATIONS REPRESENTING PRIVATE INDUSTRY (INCLUDING THE PHARMACEUTICAL, BIOTECHNOLOGY, DIAGNOSTICS, AND INFORMATION TECHNOLOGY INDUSTRIES) AND NOT-FOR-PROFIT ORGANIZATIONS (INCLUDING ASSOCIATIONS, ADVOCACY GROUPS, TRADE ORGANIZATIONS, AND PHILANTHROPIC ORGANIZATIONS) THAT WISH TO SUPPORT BIOMARKERS DEVELOPMENT ARE ELIGIBLE TO BECOME CONTRIBUTING MEMBERS.GENECONVENE THE GENECONVENE GLOBAL COLLABORATIVE ADVANCES BEST PRACTICES AND INFORMED DECISION MAKING FOR DEVELOPMENT OF GENETIC BIOCONTROL TECHNOLOGIES TO IMPROVE PUBLIC HEALTH. GENECONVENE OFFERS TECHNICAL INFORMATION, ADVICE, TRAINING, AND COORDINATION FOR RESEARCH ON GENE DRIVE AND OTHER GENETIC BIOCONTROL TECHNOLOGIES TECHNOLOGIES THAT USE GENETIC VARIANTS OF A TARGET SPECIES, LIKE A DISEASE-TRANSMITTING MOSQUITO, TO CONTROL ITS UNDESIRABLE IMPACTS. EFFORTS TO CONTROL THE SPREAD OF MOSQUITO-BORNE DISEASES SAVE HUNDREDS OF THOUSANDS OF LIVES EVERY YEAR, BUT THE TOOLS AND RESOURCES AVAILABLE ARE NOT SUFFICIENT TO PROTECT EVERYONE. GENE DRIVE IS RECOGNIZED AS A POTENTIALLY POWERFUL TOOL TO HELP CONTROL MALARIA. GENETIC BIOCONTROL HAS BEEN USED ON DISEASE-TRANSMITTING MOSQUITOES FOR OVER 60 YEARS, BUT SCIENTIFIC ADVANCES IN THE PAST 20 YEARS HAVE DRAMATICALLY IMPROVED THE ABILITY OF RESEARCHERS TO ENGINEER NEW GENETIC BIOCONTROL APPROACHES, INCLUDING GENE DRIVES. GENECONVENE WAS CREATED TO SUPPORT INFORMED DECISION MAKING ON THE OPEN SCIENTIFIC, REGULATORY, AND POLICY QUESTIONS RAISED BY THESE NEW TECHNOLOGIES.RESEARCH PROGRAMS FOR ACCELERATING NEW THERAPIESIMPROVING HEART HEALTH WITH THE AMP HEART FAILURE PROGRAMTHE ACCELERATING MEDICINES PARTNERSHIP PROGRAM IN HEART FAILURE AMP HF, LAUNCHED ON SEPTEMBER 29, 2022, SEEKS TO ADDRESS A CRITICAL UNMET NEED IN CARDIOVASCULAR HEALTH BY BETTER UNDERSTANDING THE PHENOTYPIC DIVERSITY OF HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFPEF) THAT WILL ALLOW FOR THE IDENTIFICATION OF NOVEL PROTEINS OR GENES WITH THE POTENTIAL TO SERVE AS THERAPEUTIC TARGETS.BRINGING TOGETHER RESOURCES FROM THE NIH'S NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI), U.S. FOOD AND DRUG ADMINISTRATION (FDA), AND SEVEN INDUSTRY AND NON-PROFIT PARTNERS, THE AMP HF LAUNCHED WITH COMBINED COMMITMENTS TOTALING $37 MILLION. THE AMP HF INAUGURATION PRECEDED THE HEART FAILURE SOCIETY OF AMERICA'S ANNUAL MEETING AT NATIONAL HARBOR, MARYLAND, WITH REPRESENTATION FROM 17 STAKEHOLDERS FROM INDUSTRY, ACADEMIA, GOVERNMENT, AND NON-PROFIT ORGANIZATIONS.AT THE INAUGURATION, THE NHLBI'S HEARTSHARE PROGRAM HOSTED A WORKSHOP HIGHLIGHTING THE PROGRESS OF SIX CLINICAL CENTERS IN ITS PROGRAM. THE AMP HF BUILDS ON THE INFRASTRUCTURE CREATED BY HEARTSHARE WHOSE GOALS CLOSELY ALIGN WITH THE AMP HF PROJECT: DECONSTRUCTION OF HFPEF SYNDROME LEADING TO THE DISCOVERY OF POTENTIAL THERAPEUTIC TARGETS. SINCE THE AMP HF LAUNCH, THE HEARTSHARE WEBSITE HAS BEEN REBRANDED BRINGING TOGETHER ALL RESOURCES AND KNOWLEDGE UNDER A SINGLE, UNIFIED PORTAL. TO LEARN MORE ABOUT THE AMP HF STUDY DESIGN, PLEASE VISIT THIS ARTICLE BY NATURE REVIEWS DRUG DISCOVERY.REVOLUTIONIZING LIVER DISEASE DIAGNOSIS AND TREATMENT WITH THE NIMBLE INITIATIVENONALCOHOLIC STEATOHEPATITIS, OR NASH, IS A SERIOUS LIVER CONDITION ASSOCIATED WITH OBESITY AND TYPE 2 DIABETES. IT IMPACTS BETWEEN 9 AND 15 MILLION PEOPLE IN THE UNITED STATES. THE CONDITION, WHICH IS A PROGRESSED VERSION OF NONALCOHOLIC FATTY LIVER DISEASE, IS CAUSED BY A BUILDUP OF FAT IN THE LIVER, LEADING TO INFLAMMATION AND SCARRING. INDIVIDUALS WITH NASH OFTEN SHOW VERY FEW EARLY SYMPTOMS. AS A RESULT, THIS ELUSIVE DISEASE FREQUENTLY REMAINS UNDIAGNOSED. MANY PATIENTS ONLY DISCOVER THEY HAVE THE CONDITION AFTER IT HAS PROGRESSED TO CIRRHOSIS, A LATE-STAGE, IRREVERSIBLE FORM OF LIVER SCARRING, OR DEADLY LIVER CANCER.CURRENTLY, AN INVASIVE AND PAINFUL LIVER BIOPSY IS THE ONLY METHOD AVAILABLE TO DIAGNOSE NASH. UNFORTUNATELY, PATIENTS TEND TO BALK AT UNDERGOING REPEATED BIOPSIES OR ENROLLING IN DRUG DEVELOPMENT TRIALS THAT EMPLOY BIOPSIES. WITH THESE CONCERNS IN MIND, FNIH'S NONINVASIVE BIOMARKERS OF METABOLIC LIVER DISEASE (NIMBLE) INITIATIVE IS WORKING TO STANDARDIZE AND COMPARE THE BEST TOOLS FOR DIAGNOSING NASH, INCLUDING NONINVASIVE AND MORE ACCURATE BLOOD-BASED AND IMAGING BIOMARKERS. THE COMPLETED FIRST STAGE OF THE NIMBLE PROJECT HAS SUCCESSFULLY MADE ADVANCEMENTS TOWARDS NONINVASIVE LIVER TESTING. THE FDA HAS ACCEPTED LETTERS OF INTENT (LOIS) FOR 10 NONINVASIVE BIOMARKERS BEING TESTED IN NIMBLE BOTH BLOOD-BASED AND IMAGING-BASED TO SERVE AS ENRICHMENT TOOLS FOR DIAGNOSING "AT RISK" NASH.NIMBLE STAGE 1 FINDINGS DEMONSTRATE THAT NONINVASIVE BIOMARKERS CAN DIAGNOSE "AT RISK" POPULATIONS THAT ARE LIKELY TO PROGRESS TO CIRRHOSIS. THIS WILL REDUCE THE NUMBER OF PATIENTS WHO NEED TO BE CONFIRMED THROUGH BIOPSY PROCEDURES, WHICH THEN REDUCES THE RISK OF MORBIDITY RESULTING FROM BIOPSIES, ENHANCES PATIENT SAFETY, AND BOOSTS THE EFFICIENCY OF CLINICAL TRIALS.THIS IDENTIFICATION OF PATIENTS WHO ARE LIKELY IN THE "AT RISK" CATEGORY ALSO INCREASES THE POTENTIAL FOR THEM TO BE RECRUITED TO CLINICAL TRIALS FOR DEVELOPING DISEASE-ALTERING THERAPIES. THIS REDUCES THE USE OF CLINICAL TRIAL RESOURCES SIGNIFICANTLY, RESULTING IN SUBSTANTIAL COST SAVINGS FOR CLINICAL TRIAL SPONSORS. 1173980 543536 SEE SCHEDULE O, PROGRAM TWO, AWARDS, EVENTS, EDUCATION/TRAINING PROGRAMSPROGRAM TWO - AWARDS, EVENTS, EDUCATION/TRAINING PROGRAMS - POWERING SCIENCE: 2022 FNIH AWARDS THE LURIE PRIZE IN BIOMEDICAL SCIENCESIN 2022, THE LURIE PRIZE IN BIOMEDICAL SCIENCES RECOGNIZED THE OUTSTANDING ACHIEVEMENTS OF TWO RESEARCHERS STUDYING THE AGING PROCESS, EACH OF WHOSE WORK HAS PARALLELED AND COMPLEMENTED THE OTHER'S OVER THE PAST 20 YEARS. BOTH WINNERS OF THE 10TH ANNUAL LURIE PRIZE IN BIOMEDICAL SCIENCES HAVE ACHIEVED INCREDIBLE MILESTONES IN BIOMEDICAL SCIENCE, AND THE FNIH IS PROUD TO HONOR THEIR EFFORTS.THE AWARD INCLUDED A $100,000 HONORARIUM, SPLIT BETWEEN THE TWO WINNERS AND MADE POSSIBLE BY A DONATION TO THE FNIH BY PHILANTHROPIST ANN LURIE, PRESIDENT OF THE ANN AND ROBERT H. LURIE FOUNDATION, PRESIDENT OF LURIE HOLDINGS, INC., AND HONORARY FNIH BOARD MEMBER. A DISTINGUISHED JURY OF BIOMEDICAL RESEARCHERS, CHAIRED BY FNIH BOARD MEMBER SOLOMON H. SNYDER, MD, SELECTED THE 2022 WINNERS.2022 AWARD RECIPIENT: ANNE BRUNET, PHD, IS THE MICHELE AND TIMOTHY BARAKETT PROFESSOR OF GENETICS AT STANFORD UNIVERSITY. DR. BRUNET EMPLOYS A UNIQUE MULTI-ORGANISMAL APPROACH TO INVESTIGATE THE ABILITY OF ENZYMES TO REGULATE GENES IMPLICATED IN AGING AND HAS IDENTIFIED GENES AND PATHWAYS CRITICAL FOR MAINTAINING NEURAL STEM CELLS THAT MAY HELP PRESERVE BRAIN FUNCTION DURING AGING. 2022 AWARD RECIPIENT: ANDREW DILLIN, PHD, IS A HOWARD HUGHES MEDICAL INSTITUTE INVESTIGATOR AND THE THOMAS AND STACEY SIEBEL DISTINGUISHED CHAIR IN STEM CELL RESEARCH AT THE DEPARTMENT OF MOLECULAR AND CELL BIOLOGY AT THE UNIVERSITY OF CALIFORNIA, BERKELEY. DR. DILLIN EXPLORES THE ABILITY OF ORGANISMS TO SUSTAIN PROPER PROTEIN PRODUCTION PROCESSES ESSENTIAL TO MAINTAINING CELLULAR STRUCTURE AND FUNCTION IN AGINGTRAILBLAZER PRIZE FOR CLINICIAN-SCIENTISTSTHE FNIH TRAILBLAZER PRIZE FOR CLINICIAN-SCIENTISTS RECOGNIZES THE OUTSTANDING CONTRIBUTIONS OF EARLY CAREER CLINICIAN-SCIENTISTS WHOSE WORK HAS THE POTENTIAL TO, OR HAS LED TO, INNOVATIONS IN PATIENT CARE. IN SEARCHING FOR POTENTIAL WINNERS, WE SEEK TO HIGHLIGHT TRUE SCIENTIFIC INNOVATORS AND THIS YEAR WAS NO EXCEPTION. CONGRATULATIONS WENT TO TWO 2022 TRAILBLAZER PRIZE WINNERS.THIS $10,000 HONORARIUM AND PRIZE, SPLIT BETWEEN THE TWO WINNERS, CELEBRATES THE TRANSFORMATIONAL WORK OF INDIVIDUALS WHOSE RESEARCH TRANSLATES BASIC SCIENTIFIC OBSERVATIONS INTO NEW PARADIGM-SHIFTING APPROACHES FOR DIAGNOSING, PREVENTING, TREATING, OR CURING DISEASE AND DISABILITY. THE TRAILBLAZER PRIZE IS MADE POSSIBLE BY A GENEROUS DONATION FROM JOHN I. GALLIN, MD, AND ELAINE GALLIN, PHD.2022 AWARD RECIPIENT: ELIEZER VAN ALLEN, MD IS ASSOCIATE PROFESSOR OF MEDICINE AT HARVARD MEDICAL SCHOOL, CHIEF OF THE DIVISION OF POPULATION SCIENCES AT THE DANA-FARBER CANCER INSTITUTE, AND ASSOCIATE MEMBER OF THE BROAD INSTITUTE. DR. VAN ALLEN HAS MADE SIGNIFICANT CONTRIBUTIONS TO THE ADVANCEMENT OF THE SCIENCE OF PERSONALIZED CANCER CARE. USING INNOVATIVE COMPUTATIONAL APPROACHES, DR. VAN ALLEN'S RESEARCH IS HELPING DETERMINE THE IMPACT OF BOTH INHERITED AND ENVIRONMENTAL FACTORS ON CANCER AND THE INFLUENCE OF GENES ON AN INDIVIDUAL'S RESPONSE TO CANCER TREATMENT.2022 AWARD RECIPIENT: NIKHIL WAGLE, MD, IS ASSOCIATE PROFESSOR OF MEDICINE AT HARVARD MEDICAL SCHOOL, INSTITUTE MEMBER OF THE BROAD INSTITUTE, AND AN ONCOLOGIST SPECIALIZING IN BREAST CANCER AT THE DANA-FARBER CANCER INSTITUTE. DR. WAGLE DEVELOPED NOVEL GENE SEQUENCING APPROACHES TO PROFILING CANCER MUTATIONS THAT AFFECT TREATMENT RESPONSE AND DRUG RESISTANCE. IN ADDITION, DR. WAGLE DIRECTS COUNT ME IN, AN INNOVATIVE PARTNERSHIP BETWEEN PATIENTS AND RESEARCHERS THAT EMPOWERS PATIENTS TO ACTIVELY PARTICIPATE IN CANCER RESEARCH AND SPEED THE DISCOVERY OF NEW TREATMENTS. CHARLES A. SANDERS, MD, PARTNERSHIP AWARDIN HONOR OF FORMER FNIH CHAIRMAN OF THE BOARD, CHARLES A. SANDERS, MD, WE CELEBRATE OUR PARTNERS AND THEIR CONTRIBUTIONS THROUGH THE ANNUAL PARTNERSHIP AWARD. IN KEEPING WITH DR. SANDERS' VISION, THE AWARD RECOGNIZES PERSONS AND/OR ORGANIZATIONS THAT HAVE MADE SIGNIFICANT CONTRIBUTIONS TO OUR WORK IN CREATING, IMPLEMENTING, AND NURTURING PRIVATE-PUBLIC PARTNERSHIPS THAT BUILD BRIDGES TO BREAKTHROUGHS IN IMPROVED THERAPEUTICS, DIAGNOSTICS, AND POTENTIAL CURES. A COMMITTEE COMPRISED OF FNIH BOARD MEMBERS SELECTED TWO PARTNERS FOR 2022, AMGEN AND FRANCIS S. COLLINS, MD, PHD, WHO HAVE SUPPORTED AND ACCELERATED THE WORK OF THE FNIH FOR MANY YEARS.2022 AWARD RECIPIENT AMGEN: AMGEN'S PARTNERSHIP OVER MANY YEARS HAS HAD A STRONG IMPACT ON A DIVERSE SLATE OF FNIH INITIATIVES, FROM CLINICAL TRIALS TO MENTORSHIPS TO EDUCATIONAL PROGRAMS. GENEROUS FINANCIAL AND SCIENTIFIC SUPPORT FROM AMGEN, A MEMBER OF THE FNIH BIOMARKERS CONSORTIUM, HAS ADVANCED FNIH RESEARCH INITIATIVES IN CANCER, IMMUNOTHERAPY, CARDIOMETABOLIC DISEASE, AND PRECISION MEDICINE. 2022 AWARD RECIPIENT FRANCIS COLLINS, MD, PHD: AS NIH DIRECTOR FROM 2009 TO 2021, DR. FRANCIS S. COLLINS ROBUSTLY SUPPORTED THE MISSION OF THE FNIH, ADVANCING A REMARKABLE LIST OF INITIATIVES TO EXPAND SCIENTIFIC KNOWLEDGE AND PAVE THE WAY FOR HUMAN RIGHTS, PRIVACY ISSUES, AND ETHICS. DR. COLLINS PARTNERED WITH THE NIH'S NATIONAL HUMAN GENOME RESEARCH INSTITUTE AND THE GENETIC ASSOCIATION INFORMATION NETWORK (GAIN) TO CREATE A SIGNIFICANT RESOURCE FOR GENETIC RESEARCHERS. HE HELPED ESTABLISH THE NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS), PROVIDING A CRITICAL VENUE FOR PRECOMPETITIVE PUBLIC-PRIVATE COLLABORATION TO SPEED THE TRANSFORMATION OF BASIC RESEARCH INTO PATIENT THERAPEUTICS. THIS LED TO THE LAUNCH OF THE FNIH-MANAGED ACCELERATING MEDICINES PARTNERSHIP (AMP) PROGRAMA POWERFUL COLLABORATION BETWEEN THE NIH, THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), AND PUBLIC AND PRIVATE ORGANIZATIONS. HE ALSO MANAGED TWO OF THE LARGEST CRISES CHALLENGING HUMAN HEALTH VIA FNIH INITIATIVES: THE HELPING TO END ADDICTION LONG-TERM INITIATIVE (HEAL) AND ACTIV (ACCELERATING COVID-19 THERAPEUTIC INTERVENTIONS AND VACCINES).EVENTS AND EDUCATIONTHE MEETINGS AND EVENTS DEPARTMENT CONCEPTUALIZES, PLANS, EXECUTES AND EVALUATES HIGH-QUALITY, PRODUCTIVE, INNOVATIVE AND ECONOMICAL CONVENINGS THAT ADVANCE THE ORGANIZATION'S MISSION. THESE CONVENINGS INCLUDE, BUT ARE NOT LIMITED TO, RESEARCH PROJECT TEAM MEETINGS AND CONFERENCES, DONOR STEWARDSHIP LECTURES AND SYMPOSIA AND SPECIAL EVENTS. THE DEPARTMENT OVERSEES THE MANAGEMENT OF FNIH HIGHLY RESPECTED AWARDS AND PRIZES. SOME OF THE FNIH'S MARQUEE EVENTS IN 2022 INCLUDED: THE FNIH AWARDS CEREMONY, THE CANCER STEERING COMMITTEE'S ANNUAL SYMPOSIUM, AND THE GENECONVENE VIRTUAL INSTITUTE WEBINARS SERIES.IN PARTNERSHIP WITH NIH AND OUR PHILANTHROPIC SUPPORTERS, WE FUND AND ADMINISTER TRAINING PROGRAMS THAT PROVIDE OPPORTUNITIES TO STUDENTS OF SCIENCE, FROM HIGH SCHOOLERS TO POST-DOCTORAL SCHOLARS. HERE ARE A FEW EXAMPLES OF THESE PROGRAMS IN ACTION:-ANNUALLY, THE MEDICAL RESEARCH SCHOLARS PROGRAM ENROLLS 50 MEDICAL, DENTAL, AND VETERINARY STUDENTS IN A YEAR-LONG RESEARCH TRAINING AND MENTORSHIP PROGRAM, INCLUDING LECTURES, CLINICAL TEACHING ROUNDS, AND A RESEARCH SYMPOSIUM.-THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE'S HEALTH DISPARITIES IN TRIBAL COMMUNITIES SUMMER INTERNSHIP PROGRAM (HDTC-SIP) PROVIDES STEM EXPOSURE TO STUDENTS FROM UNDERREPRESENTED POPULATIONS.-THE AMGEN SCHOLARS PROGRAM OFFERS SUMMER TRAINING FOR UNDERGRADUATES TO PARTICIPATE IN CUTTING-EDGE RESEARCH.-THE PEW LATIN AMERICAN FELLOWS PROGRAM PROVIDES POST-DOCTORAL TRAINING TO YOUNG STUDENT SCIENTISTS FROM LATIN AMERICA.WE SUPPORT SCIENTISTS AND PROMOTE THEM THROUGH ANNUAL LECTURES AT THE NATIONAL EYE INSTITUTE, THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE, THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, THE NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH, AND ELSEWHERE.MEANWHILE, LEGACY FUNDS FROM INDIVIDUAL BENEFACTORS, SUCH AS THE JAMES T. WENDEL FUND THAT SUPPORTS NEUROLOGICAL RESEARCH IN THE LAB OF NIH'S DR. CARSTEN BONNEMANN, HELP MOVE SCIENTIFIC ACHIEVEMENT FARTHER, FASTER, GIVING HOPE TO FUTURE PATIENTS. THE WILLIAM AND BUFFY CAFRITZ FAMILY FOUNDATION IS ALSO MOVING THE NEEDLE ON NOVEL RESEARCH THROUGH THE PAMELA ANNE CAFRITZ RENAL CELL CARCINOMA AWARD, WHICH SEEKS TO ATTRACT NEW INVESTIGATORS-PARTICULARLY WOMEN-TO KIDNEY CANCER RESEARCH AT THE CENTER FOR CANCER RESEARCH, NATIONAL CANCER INSTITUTE.INDIVIDUAL PROGRAMS, SUCH AS THE SALLIE ROSEN KAPLAN FUND FOR WOMEN SCIENTISTS IN CANCER RESEARCH AND THE DEEDA BLAIR RESEARCH INITIATIVE FOR DISORDERS OF THE BRAIN, PROVIDE FINANCIAL SUPPORT, MENTORING, AND RECOGNITION TO PROMISING YOUNG SCIENTISTS.IN 2022, THE 2021 RECIPIENTS OF THE DEEDA BLAIR RESEARCH INITIATIVE FOR DISORDERS OF THE BRAIN USED THEIR AWARD AND RECOGNITION TO MAKE SIGNIFICANT INROADS IN BOTH THEIR RESEARCH AND THEIR PROFESSIONAL STANDING. 70388450 1 1 0 1 0 1 0 0 0 1 1 0 0 0 1 1 1 0 0 0 1 1 0 1 1 0 0 1 1 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 46 0 1 90 1 0 0 0 0 0 1 1 0 0 0 0 0 0 X 25 24 0 0 0 0 0 0 0 1 1 0 0 1 1 1 1 1 1 1 1 0 MD VA AL AK AR CA CO CT DC FL GA HI IL KS KY ME MA MI MN MS NV NH NJ NM NY NC ND OH OK OR PA RI SC TN UT WA WV WI X X DONALD M HILL 3014356246 11400 ROCKVILLE PIKE 600 NORTH BETHESDA MD 20852 DR STEVEN M PAUL CHAIRMAN 1.50 X X 0 0 0 DR SOLOMON H SNYDER VICE-CHAIRMAN 0.50 X X 0 0 0 MR STEVEN C MAYER TREASURER 2.00 X X 0 0 0 MRS WILLIAM MCCORMICK BLAIR JR SECRETARY 1.00 X X 0 0 0 DR JULIE L GERBERDING CEO (START MAY 2022) 40.00 X X 314575 0 9931 DR KATHY BLOOMGARDEN BOARD MEMBER (UNTIL DEC. 2022) 0.50 X 0 0 0 DR MARIJN DEKKERS BOARD MEMBER 0.50 X 0 0 0 MR JAMES H DONOVAN BOARD MEMBER 0.50 X 0 0 0 DR PAUL L HERRLING BOARD MEMBER 0.50 X 0 0 0 DR THOMAS R INSEL BOARD MEMBER 0.50 X 0 0 0 DR JUDY LANSING KOVLER BOARD MEMBER 0.50 X 0 0 0 DR RONALD L KRALL BOARD MEMBER 0.50 X 0 0 0 DR FREDA LEWIS-HALL BOARD MEMBER 0.50 X 0 0 0 JULIE BELL LINDSAY BOARD MEMBER 0.50 X 0 0 0 DR EDISON T LIU BOARD MEMBER 0.50 X 0 0 0 MR JOEL S MARCUS BOARD MEMBER 0.50 X 0 0 0 GILBERT S OMENN BOARD MEMBER 0.50 X 0 0 0 DAME JILLIAN SACKLER BOARD MEMBER 0.50 X 0 0 0 MRS LILY SAFRA BOARD MEMBER (UNTIL JULY 2022) 0.50 X 0 0 0 DR CHARLES A SANDERS BOARD MEMBER 0.50 X 0 0 0 MR FRED SEIGEL BOARD MEMBER 0.50 X 0 0 0 DR ELLEN V SIGAL BOARD MEMBER 0.50 X 0 0 0 MR RUSSELL W STEENBERG BOARD MEMBER 0.50 X 0 0 0 DR PAUL STOFFELS BOARD MEMBER 0.50 X 0 0 0 DR ELIAS ZERHOUNI BOARD MEMBER 0.50 X 0 0 0 DAVID WHOLLEY EXEC. VP, STRATEGY & BUSINESS DEVELOPMENT 40.00 X 513679 0 38966 DONALD M HILL CHIEF FINANCIAL OFFICER 40.00 X 277640 0 37972 KEVIN A KLOCK SR. VP OF OPERATIONS & LEGAL AFFAIRS 40.00 X 263184 0 34602 MICHAEL SANTOS VICE PRESIDENT OF SCIENCE 40.00 X 348716 0 31698 JULIE WOLF-RODDA CHIEF STRATEGIC ALLIANCES & ADVANCEMENT OFFICER 40.00 X 329125 0 38966 JOSEPH P MENETSKI VP OF RESEARCH PARTNERSHIPS 40.00 X 301247 0 36795 STACEY ADAM ASSOCIATE VP, RESEARCH PARTNERSHIPS 40.00 X 235748 0 26042 STEVEN HOFFMANN ASSOCIATE VP, RESEARCH PARTNERSHIPS 40.00 X 218627 0 30234 COURTNEY SILVERTHORN ASSOCIATE VP, RESEARCH PARTNERSHIPS 40.00 X 211603 0 24500 EVA COYNE VICE PRESIDENT & CONTROLLER 40.00 X 207270 0 32329 DAVID O'BROCHTA SCIENTIFIC PROGRAM MANAGER, TECHNICAL LEAD OF GENE 40.00 X 199952 0 31704 3421366 0 373739 43 0 1 0 SWOG CTI 24 FRANK LLOYD WRIGHT DRIVE PO BOX ANN ARBOR MI 48105 CLINICAL TRIAL FOR LUNG MAP PROJECT 7225965 DELOITTE CONSULTING LLP 4022 SELLS DRIVE HERMITAGE TN 37076 COVID-19 PROJECT PROFESSIONAL SERVICES 2408787 DANA-FARBER CANCER INSTITUTE 450 BROOKLINE AVENUE BOSTON MA 02215 THE PACT, MRD & CTDNA RESEARCH COLLABORA 1593527 THE UNIVERSITY OF TEXASMD ANDERSON PO BOX 4266 HOUSTON TX 77210 THE PACT PROJECT RESEARCH COLLABORATION 1348679 ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI ONE GUSTAVE L LEVY PLACE NEW YORK NY 10029 THE PACT & THE MUCOSAL HEALING ULCERATIV 1097909 30 221000 2000000 66777263 4121955 68998263 ADMINISTRATIVE REVENUE 900099 50000 50000 50000 2204173 2204173 137517946 138262362 -744416 -744416 -744416 430525 221000 353346 77179 77179 70585199 50000 0 1536936 31526028 31526028 107500 107500 488047 488047 2577096 949715 1616338 11043 7378822 5077247 2300194 1381 631787 375329 245919 10539 1446996 908822 511386 26788 700125 357994 342131 231734 174800 55515 1419 104328 15750 88578 190215 190215 22534 16276 6258 14111 5007 9104 128139 27674 42410 58055 743745 179469 564276 1584497 1472506 79058 32933 233480 233480 241849 133789 108060 PROGRAM CONTRACTS 23379246 23379246 CONSULTANTS 5078454 4736266 342188 BAD DEBT EXPENSE 200000 200000 RECRUITING 141708 127196 14512 267669 129789 137855 25 77418110 70388450 6887477 142183 47993053 73162269 67125693 49795550 230354 255982 3044663 1473431 1725769 1571232 101529635 84510224 3335255 7287285 221939759 216582542 8537356 8918557 338978 783334 2114103 8553216 10990437 18255107 X 28544211 27430780 182405111 170896655 210949322 198327435 221939759 216582542 -6832911 -5788976 0 X X 0 1 X 1 1 1 X 60444618 50623645 98343956 105993785 68998263 384404267 60444618 50623645 98343956 105993785 68998263 384404267 133730186 250674081 2057158 2818334 1722957 1346882 2204173 10149504 394553771 114723 0.63530 0.59950 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 0 1 0 0 0 0 1 0 0 0 0 PART II-B, LINE 1: FNIH CONSULTED ITS CONGRESSIONAL COMMITTEES OF JURISDICTION ON PUBLIC HEALTH LEGISLATION. 1 3800 17623 203378 1 1 0 0 24511134 -85775 -788802 2807342 20829215 20878035 3154350 544664 65915 24511134 14897505 5648998 419982 88450 20878035 12514811 1788682 705900 111888 14897505 11920726 1032217 -267231 103397 67504 12514811 0.76819 0.23181 0 0 1869159 590503 1278656 1175504 882928 292576 1571232 CHARITABLE GIFT ANNUITY 114097 OPERATING LEASE LIABILITY 8439119 8553216 X 65280120 -5788976 320766 -5468210 70748330 190215 -353346 -163131 70585199 77902007 320766 353346 674112 77227895 190215 190215 77418110 PART V, LINE 4: THE FOUNDATION HAS ONE ENDOWMENT THAT IS FUNDED BY MULTIPLE DONORS TO SEED NEW DISCOVERIES AND/OR BE AVAILABLE TO RESPOND TO EPIDEMICS AND FOUNDATION'S UNANTICIPATED NEEDS. THE FOUNDATION'S OTHER ENDOWMENTS CONSIST OF INDIVIDUAL DONOR-RESTRICTED ENDOWMENT FUNDS ESTABLISHED FOR A VARIETY OF PURPOSE. (E.G. VARIETY OF RESEARCH AND EDUCATIONAL INITIATIVES AT THE FOUNDATION FOR THE NIH, INC). NET ASSETS ASSOCIATED WITH ENDOWMENT FUNDS ARE CLASSIFIED AND REPORTED BASED ON THE EXISTENCE OR ABSENCE OR DONOR-IMPOSED RESTRICTIONS. PART X, LINE 2: THE FOUNDATION IS EXEMPT FROM FEDERAL INCOME TAXES UNDER SECTION 501(C)(3) OF THE INTERNAL REVENUE CODE; ACCORDINGLY, THE ACCOMPANYING FINANCIAL STATEMENTS DO NOT REFLECT A PROVISION OR LIABILITY FOR FEDERAL AND STATE INCOME TAXES. THE FOUNDATION HAS DETERMINED THAT IT DOES NOT HAVE ANY MATERIAL UNRECOGNIZED TAX BENEFITS OR OBLIGATIONS AS OF DECEMBER 31, 2022 AND 2021. PART XI, LINE 4B - OTHER ADJUSTMENTS: FUNDRAISING DIRECT EXPENSE -353,346. PART XII, LINE 2D - OTHER ADJUSTMENTS: FUNDRAISING DIRECT EXPENSE 353,346. 1 EUROPE (INCLUDING ICELAND & GREENLAND) 0 0 GRANTMAKING 426370 SUB-SAHARAN AFRICA 0 0 GRANTMAKING 21677 NORTH AMERICA 0 0 GRANTMAKING 40000 0 0 0 0 0 0 488047 0 488047 SUB-SAHARAN AFRICA RESEARCH 21677 WIRE TRANSFER 0 EUROPE (INCLUDING ICELAND & GREENLAND) RESEARCH 426370 WIRE TRANSFER 0 NORTH AMERICA RESEARCH 40000 WIRE TRANSFER 0 0 3 0 0 0 0 0 0 PART I, LINE 2: PROGRAM AND GRANTS MANAGEMENT STAFF INVEST CONSIDERABLE EFFORT IN PROVIDING SCIENTIFIC, ADMINISTRATIVE, AND FISCAL OVERSIGHT FOR FNIH GRANTS. SCIENTIFIC AND TECHNICAL PROGRESS IS MONITORED THROUGH SEMI-ANNUAL AND ANNUAL REPORTS FROM THE GRANTEES AS WELL AS THROUGH DIRECT CONTACT WITH INVESTIGATORS BOTH BY TELECONFERENCE AND SITE VISITS, AND FOLLOW UP TO PROGRESS REPORTS AND SITE VISITS WHERE SCIENTIFIC QUESTIONS OR ADMINISTRATIVE ISSUES ARE IDENTIFIED. SCIENTIFIC REPORT SUBMISSIONS COVER A WIDE RANGE OF ITEMS INCLUDING INDIVIDUAL OBJECTIVES AND OVERALL PROGRESS REVIEW, MILESTONE ACHIEVEMENT, PROJECT PLAN UPDATE, AND ANY OTHER SIGNIFICANT CHANGES. FINANCIAL REPORTING IS REQUIRED ANNUALLY FOR ALL OF THE GRANTEES, AND SEMI-ANNUALLY FOR INSTITUTIONS THAT REQUIRE ADDITIONAL OVERSIGHT, SUCH AS SOME DEVELOPING COUNTRY INSTITUTIONS. DUE DILIGENCE PROCEDURES, SUCH AS FNIH COMPLIANCE WITH THE USA PATRIOT ACT AND IRS REQUIREMENTS ON EXPENDITURE RESPONSIBILITIES, HAVE BEEN INCORPORATED INTO THE REPORTING PROCESS TO ENSURE THAT THE GRANTEES ARE COMPLYING WITH GRANT, LEGAL, FINANCIAL, AND REGULATORY REQUIREMENTS. PART III ACCOUNTING METHOD: X X X X X 1 MICHAEL J WORTH & ASSOCIATES 3622 JENIFER STREET NW WASHINGTON DC 20015 PLANNED GIVING CONSULTING SERVICES (STRENGTHENING PLANNED GI 0 0 15000 -15000 15000 -15000 MD VA AL AK AR CA CO CT DC FL GA HI IL KS KY ME MA MI MN MS NV NH NJ NM NY NC ND OH OK OR PA RI SC TN UT WA WV WI 2022 FNIH AWARD CEREMONY 2000 2000 2704 2023 FNIH AWARD CEREMONY 649525 221000 428525 33133 317509 651525 221000 430525 33133 320213 353346 77179 1 NIHCC - CLINICAL CENTER 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 28754 0 RESEARCH NIH NIA 9001 ROCKVILLE PIKE BETHESDA MD 20893 520858116 170(C)(1) GOVERNMENT 2901055 0 RESEARCH NIHNCI 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 5827431 0 RESEARCH NIHNIAID 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 5440078 0 RESEARCH NIHNIAMS 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 3700000 0 RESEARCH NIHNINDS 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 1078415 0 RESEARCH NIH NHLBI 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 598380 0 RESEARCH NIHOD 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 99215 0 RESEARCH NIH NIMH 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 3779046 0 RESEARCH RESEARCH TRIANGLE INSTITUTE PO BOX 900002 RALEIGH NC 27675 560686338 501(C)(3) 1041504 0 RESEARCH UNIVERSITY OF ALABAMA AT BIRMINGHAM DEPT OF PEDIATRIC ADMIN LOWDER BLDG 608 1600 7TH AVENUE SOUTH BIRMINGHAM AL 35233 636001138 501(C)(3) 1129930 0 RESEARCH THOMAS JEFFERSON UNIVERSITY 125 SOUTH 9TH STREET 2ND FLOOR SHERIDAN BUILDING PHILADELPHIA PA 19107 231352651 501(C)(3) 498980 0 RESEARCH GEORGETOWN UNIVERSITY 3700 O STREET NW WASHINGTON DC 20057 530196603 501(C)(3) 24734 0 RESEARCH UNIVERSITY OF NORTH CAROLINA CHAPEL HILL 104 AIRPORT DRIVE SUITE 2200 CAMPUS BOX 1350 CHAPEL HILL NC 27599 800543561 501(C)(3) 216595 0 RESEARCH THE TRUSTEES OF COLUMBIA UNIVERSITY PO BOX 29789 GENERAL POST OFFICE NEW YORK NY 10087 135598093 501(C)(3) 287875 0 RESEARCH TRUSTEES OF INDIANA UNIVERSITY THE POPLARS BUILDING400 E SEVENTH ST BLOOMINGTON IN 47405 356001673 501(C)(3) 228729 0 RESEARCH UNIVERSITY OF VIRGINIA PO BOX 400195 CHARLOTTESVILLE VA 22904 546001796 501(C)(3) 176560 0 RESEARCH UNIVERSITY OF COLORADO DENVER PO BOX 910238 DENVER CO 80291 846000555 501(C)(3) 245158 0 RESEARCH DUKE UNIVHUMAN VACCINE INSTITUTE 2200 WEST MAIN STREET SUITE 820 ERWIN SQUARE PLAZA DURHAM NC 27705 560532129 501(C)(3) 179913 0 RESEARCH FRED HUTCHINSON CANCER RESEARCH CTR 1100 FAIRVIEW AVE N SEATTLE WA 98109 237156071 501(C)(3) 858905 0 RESEARCH UNIVERSITY OF PITTSBURGH 200 LOTHROP ST BIOMEDICAL SCIENCE TOWER W 950 PITTSBURGH PA 15213 250965591 501(C)(3) 456993 0 RESEARCH TRUSTEES OF BOSTON UNIVERSITY 85 EAST NEWTON STREETM M-921 BOSTON MA 02118 042103547 501(C)(3) 593808 0 RESEARCH JOHNS HOPKINS UNIVERSITY 615 N WOLFE ST W1100 BALTIMORE MD 21205 150595110 501(C)(3) 10000 0 RESEARCH BRIGHAM & WOMEN'S HOSPITAL 1620 TREMONT STREET 3RD FLOOR RM BC 3002 BOSTON MA 02120 042312909 501(C)(3) 50000 0 RESEARCH FRIENDS OF CANCER RESEARCH 1800 M STREET NW SUITE 1050 SOUTH WASHINGTON DC 20036 521983273 501(C)(3) 138296 0 RESEARCH UNIVERSITY OF SOUTHERN CALIFORNIA SOTO STREET BUILDING 2001 SOTO STREET LOS ANGELES CA 90089 911642394 501(C)(3) 1258000 0 RESEARCH WESTERN MICHIGAN UNIVERSITY 1903 W MICHIGAN AVENUE KALAMAZOO MI 49008 386007327 501(C)(3) 17003 0 RESEARCH TRANSLATIONAL GENOMICS RESEARCH INSTITUTE 446 N FIFTH STREET SUITE 600 PHOENIX AZ 85005 331092191 501(C)(3) 86763 0 RESEARCH LEIDOS BIOMEDICAL RESEARCH INC 1050 BOYLES STREET FREDERICK MD 21702 330653185 CORPORATE ENTITY NOT 509908 0 RESEARCH GORDON RESEARCH CONFERENCES 5586 POST ROAD G02 EAST GREENWICH RI 02818 260150662 501(C)(3) 64000 0 RESEARCH 29 1 AWARDS 4 107500 FMV PART I, LINE 2: PROGRAM AND GRANTS MANAGEMENT STAFF INVEST CONSIDERABLE EFFORT IN PROVIDING SCIENTIFIC, ADMINISTRATIVE, AND FISCAL OVERSIGHT FOR FNIH GRANTS. SCIENTIFIC AND TECHNICAL PROGRESS IS MONITORED THROUGH SEMI-ANNUAL AND ANNUAL REPORTS FROM THE GRANTEES AS WELL AS THROUGH DIRECT CONTACT WITH INVESTIGATORS BOTH BY TELECONFERENCE AND SITE VISITS, AND FOLLOW UP TO PROGRESS REPORTS AND SITE VISITS WHERE SCIENTIFIC QUESTIONS OR ADMINISTRATIVE ISSUES ARE IDENTIFIED. SCIENTIFIC REPORT SUBMISSIONS COVER A WIDE RANGE OF ITEMS INCLUDING INDIVIDUAL OBJECTIVES AND OVERALL PROGRESS REVIEW, MILESTONE ACHIEVEMENT, PROJECT PLAN UPDATE, AND ANY OTHER SIGNIFICANT CHANGES. FINANCIAL REPORTING IS REQUIRED ANNUALLY FOR ALL OF THE GRANTEES, AND SEMI-ANNUALLY FOR INSTITUTIONS THAT REQUIRE ADDITIONAL OVERSIGHT, SUCH AS FOR-PROFIT INSTITUTIONS. DUE DILIGENCE PROCEDURES, SUCH AS FNIH COMPLIANCE WITH THE USA PATRIOT ACT AND IRS REQUIREMENTS ON EXPENDITURE RESPONSIBILITIES, HAVE BEEN INCORPORATED INTO THE REPORTING PROCESS TO ENSURE THAT THE GRANTEES ARE COMPLYING WITH GRANT, LEGAL, FINANCIAL, AND REGULATORY REQUIREMENTS. FELLOWS SELECTED FOR FOUNDATION FELLOWSHIPS ARE SELECTED THROUGH NATIONWIDE AND INTERNATIONAL COMPETITIONS. X 1 1 X X X X X 0 0 0 0 0 0 0 0 0 DAVID WHOLLEY EXEC. VP, STRATEGY & BUSINESS DEVELO 393629 0 109250 0 10800 0 24400 0 14566 0 552645 0 0 0 MICHAEL SANTOS VICE PRESIDENT OF SCIENCE 348716 0 0 0 0 0 24400 0 7298 0 380414 0 0 0 JULIE WOLF-RODDA CHIEF STRATEGIC ALLIANCES & ADVANCEM 274225 0 54900 0 0 0 24400 0 14566 0 368091 0 0 0 JOSEPH P MENETSKI VP OF RESEARCH PARTNERSHIPS 265247 0 36000 0 0 0 24229 0 12566 0 338042 0 0 0 DR JULIE L GERBERDING CEO (START MAY 2022) 311515 0 0 0 3060 0 0 0 9931 0 324506 0 0 0 DONALD M HILL CHIEF FINANCIAL OFFICER 267640 0 10000 0 0 0 22556 0 15416 0 315612 0 0 0 KEVIN A KLOCK SR. VP OF OPERATIONS & LEGAL AFFAIRS 255184 0 8000 0 0 0 21336 0 13266 0 297786 0 0 0 STACEY ADAM ASSOCIATE VP, RESEARCH PARTNERSHIPS 225748 0 10000 0 0 0 18844 0 7198 0 261790 0 0 0 STEVEN HOFFMANN ASSOCIATE VP, RESEARCH PARTNERSHIPS 213627 0 5000 0 0 0 17668 0 12566 0 248861 0 0 0 EVA COYNE VICE PRESIDENT & CONTROLLER 200270 0 7000 0 0 0 17013 0 15316 0 239599 0 0 0 COURTNEY SILVERTHORN ASSOCIATE VP, RESEARCH PARTNERSHIPS 211603 0 0 0 0 0 16942 0 7558 0 236103 0 0 0 DAVID O'BROCHTA SCIENTIFIC PROGRAM MANAGER, TECHNICA 199952 0 0 0 0 0 16288 0 15416 0 231656 0 0 0 PART I, LINE 1A WE PROVIDED A STIPEND FOR HOUSING TO OUR CEO. THE TERMS FOR THIS STIPEND ARE SET FORTH IN THE CEO'S EMPLOYMENT AGREEMENT. X 7 4121956 FMV 0 0 0 FORM 990, PART III, LINE 4A, PROGRAM SERVICE ACCOMPLISHMENTS CONTINUED: NIMBLE'S INNOVATIVE APPROACH HAS ALREADY SHOWN INCREDIBLE POTENTIAL FOR REVOLUTIONIZING MEDICAL RESEARCH AND PATIENT CARE. AS A RESULT OF THE INITIATIVE'S ACHIEVEMENTS, NUMEROUS ABSTRACTS WERE PRESENTED AT THE ANNUAL AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES (AASLD) CONFERENCE AND THE EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER (EASL) CONFERENCE. MOREOVER, CORRESPONDENCE WAS PUBLISHED IN THE HIGH-IMPACT JOURNAL NATURE MEDICINE HIGHLIGHTING THE PROGRAM'S FINDINGS TO DATE. STRENGTHENING THE PATIENT VOICE WITH DIGITAL MEASURES WORKSHOPS OVER THE PAST FEW YEARS, THE FNIH BIOMARKERS CONSORTIUM HAS LAUNCHED A SERIES OF DIGITAL MEASURES WORKSHOPS DESIGNED TO BRING REGULATORS, PAYERS, AND PATIENTS TOGETHER TO STREAMLINE DIGITAL MEASURE DEVELOPMENT AND IMPLEMENTATION PROCESSES. THE FIRST WORKSHOP, WHICH WAS CONDUCTED IN FEBRUARY 2020, WAS INSTRUMENTAL IN HELPING THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) BRING FORWARD THE INNOVATIVE SCIENCE AND TECHNOLOGY APPROACHES FOR NEW DRUGS (ISTAND) PROGRAM. THE WORKSHOP ALSO HELPED THE FDA REDEFINE ITS NOMENCLATURE AROUND DIGITAL HEALTH AND BIOMARKERS AND FOCUS ON DIGITAL MEASURES. THE FNIH BIOMARKERS CONSORTIUM HOSTED ITS SECOND DIGITAL MEASURES WORKSHOP SEPTEMBER 2022 IN ZURICH, SWITZERLAND, WITH A GOAL OF EMPHASIZING PATIENT-CENTRICITY IN SHAPING AND IMPROVING HOW DIGITAL MEASURES ARE IDENTIFIED, DESIGNED, AND IMPLEMENTED. THIS WORKSHOP ESTABLISHED A GLOBAL FOOTPRINT FOR FNIH AND ITS PARTNERS, ENGAGING THE EUROPEAN MEDICINES AGENCY (EMA) AND OTHER INTERNATIONAL PARTNERS IN A WAY THAT HADN'T BEEN PREVIOUSLY POSSIBLE. A THIRD FUTURE WORKSHOP WILL PROVIDE THE CRITICAL LINK BETWEEN NIH, REGULATORS, AND INDUSTRY TO ENSURE THAT ALL PLAYERS HAVE A SEAT AT THE TABLE, THAT PATIENTS ARE INCLUDED, AND THAT THE FIELD CAN COLLECTIVELY IDENTIFY PROCESSES AND CHECKS SO THAT DIGITAL HEALTH LEADS TO USEFUL TOOLS, NOT JUST MORE GADGETS. RESEARCH PROGRAMS FOR ADVANCING GLOBAL HEALTH PREVENTING SEPSIS IN LABORING MOTHERS WORLDWIDE MATERNAL AND NEONATAL SEPSIS IS ONE OF THE TOP THREE CAUSES OF MATERNAL AND NEWBORN DEATHS GLOBALLY. TO ADDRESS THIS PRESSING ISSUE AND URGENT GLOBAL NEED, THE AZITHROMYCIN PREVENTION IN LABOR USE STUDY (A-PLUS) WAS CONDUCTED BY THE EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD)'S GLOBAL NETWORK FOR WOMEN'S AND CHILDREN'S HEALTH RESEARCH AND WAS CO-FUNDED BY NICHD AND THE FNIH, WITH SUPPORT TO THE FNIH PROVIDED BY A GRANT FROM THE BILL & MELINDA GATES FOUNDATION. THE STUDY ASSESSED LOW-COST, SUSTAINABLE INTERVENTIONS TO IMPROVE MATERNAL AND CHILD HEALTH IN LOW- AND MIDDLE-INCOME COUNTRIES. AFTER A RIGOROUS PROCESS OF TRAINING AND PILOT-TESTING, INVESTIGATORS EXAMINED THE SAFETY AND EFFECTIVENESS OF A SINGLE ORAL DOSE OF AZITHROMYCIN ADMINISTERED DURING LABOR (COMPARED TO PLACEBO) IN REDUCING THE RISK OF NEONATAL AND MATERNAL SEPSIS OR DEATH IN LABORING WOMEN. THE RESULTS WERE VERY PROMISING, SUGGESTING THAT AZITHROMYCIN CAN REDUCE THE OCCURRENCE OF MATERNAL SEPSIS AND DEATH BY APPROXIMATELY ONE-THIRD. FOLLOWING THE STUDY, INVESTIGATORS RAPIDLY ANALYZED THE QUALITY OF THE DATA AND RESULTS TO ENABLE OPEN ACCESS TO THE FINDINGS IN A TIMELY MANNER. AN ABSTRACT WAS SUBMITTED TO THE WORLD'S PREMIER PREGNANCY CONFERENCE, THE SOCIETY FOR MATERNAL-FETAL MEDICINE'S ANNUAL PREGNANCY MEETING (SMFM). THE ABSTRACT WAS ACCEPTED AND BECAME THE #1 LATE-BREAKING PRESENTATION AT THE CONFERENCE IN FEBRUARY 2023. THE STUDY INVESTIGATORS ALSO SUBMITTED A MANUSCRIPT TO THE NEW ENGLAND JOURNAL OF MEDICINE (NEJM), WHICH WAS ACCEPTED AND PUBLISHED AS THE CONFERENCE PRESENTATION WAS BEING DELIVERED. AS A NEXT STEP, THE A-PLUS INVESTIGATORS WILL FOLLOW UP WITH A SUBSET OF THE MOTHERS AND INFANTS TO EXAMINE POTENTIAL ANTIMICROBIAL RESISTANCE AT MULTIPLE POINTS IN TIME, UP TO A YEAR AFTER INITIAL DELIVERY, AS A FURTHER SAFETY MEASURE. THE STUDY FINDINGS COULD RESULT IN A CHANGE TO THE CURRENT STANDARD OF CARE BY ADDING THIS SIMPLE PREVENTIVE INTERVENTION AN ADJUSTMENT THAT COULD SAVE MILLIONS OF LIVES. REDUCING ANEMIA IN POSTPARTUM WOMEN IRON DEFICIENCY ANEMIA REMAINS A MAJOR CONTRIBUTOR TO MATERNAL ILLNESS AND MORTALITY WORLDWIDE, AND DESPITE NUMEROUS EFFORTS, RATES OF ANEMIA HAVE NOT DECREASED IN LOW- AND MIDDLE-INCOME COUNTRIES. THANKFULLY, INTRAVENOUS IRON TREATMENTS HAVE BEEN DEMONSTRATED TO BE A SAFE, EFFECTIVE INTERVENTION TO REDUCE ANEMIA DURING PREGNANCY. HOWEVER, INTRAVENOUS IRON TREATMENTS HAVE NOT BEEN COMPREHENSIVELY ASSESSED DURING THE POSTPARTUM PERIOD UNTIL NOW. FIRST LAUNCHED IN NOVEMBER 2022, THE PREVENTION OF IRON DEFICIENCY ANEMIA POST-DELIVERY (PRIORITY) TRIAL AIMS TO DETERMINE IF A SINGLE-DOSE INTRAVENOUS IRON INFUSION IS MORE EFFECTIVE THAN THE CURRENT STANDARD OF CARE ORAL IRON SUPPLEMENTATION AMONG POSTPARTUM WOMEN WITH MODERATE ANEMIA IN LOW- AND MIDDLE-INCOME COUNTRIES. IN ADDITION TO COMPARING OUTCOMES FOR TREATING ANEMIA, RESEARCHERS ARE ASSESSING TRIAL PARTICIPANTS FOR IMPORTANT SECONDARY OUTCOMES RELATED TO ANEMIA, PARTICULARLY POSTPARTUM DEPRESSION, WHICH CAN AFFECT MATERNAL QUALITY OF LIFE, FATIGUE, BREASTFEEDING INITIATION AND RETENTION RATES, AND INFANT-MOTHER BONDING. THE STUDY RESULTS ARE EXPECTED TO BE USEFUL FOR INFORMING NATIONAL HEALTH POLICIES AND PRACTICES, IMPROVING THE CARE OF WOMEN. ADVISING ON AN HISTORIC GLOBAL PANDEMIC TREATY AT AN HISTORIC GATHERING IN 2021, 173 MEMBER GOVERNMENTS OF THE WORLD HEALTH ORGANIZATION (WHO) RESOLVED TO NEGOTIATE AN INTERNATIONAL AGREEMENT ON PANDEMIC PREPAREDNESS AND RESPONSE. THE FNIH, IN PARTNERSHIP WITH WHO'S COLLABORATING CENTER AT GEORGETOWN UNIVERSITY'S O'NEILL INSTITUTE FOR NATIONAL AND GLOBAL HEALTH LAW, CONVENED DOZENS OF LEADING EXPERTS FROM AROUND THE WORLD TO PROVIDE TECHNICAL ADVICE AND LEARNINGS TO POLICYMAKERS, MEMBER STATES, AND THE PUBLIC. ON THE HEELS OF THE CONSORTIUM'S REPORT ON LEGAL TOOLS FOR PANDEMIC PREPAREDNESS, THE FNIH AND O'NEILL INSTITUTE ALSO BROUGHT TOGETHER THOUGHT LEADERS TO CONSIDER THE NATIONAL SOVEREIGNTY IMPLICATIONS OF A PANDEMIC INSTRUMENT, AND TO ANALYZE THE RANGE OF AGREEMENTS PREVIOUSLY DEPLOYED TO COORDINATE INTERNATIONAL ACTIVITY AND HOW THEY MIGHT INFORM A TREATY ADDRESSING CATASTROPHIC EPIDEMIC EVENTS. IN ADDITION, THE FNIH'S KEVIN A. KLOCK, WHO CO-CHAIRS THE INITIATIVE WITH THE O'NEILL INSTITUTE'S LAWRENCE O. GOSTIN, PUBLISHED A SERIES OF SUPPORTING PAPERS IN PROMINENT JOURNALS AND OUTLETS, INCLUDING THE LANCET, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, STAT, AND THINK GLOBAL HEALTH. A THIRD CONVENING, CO-LED WITH THE JOINT UNITED NATIONS PROGRAMME ON HIV/AIDS (UNAIDS), COMMENCED IN THE SECOND HALF OF 2022 AND LED TO A 2023 REPORT CALLED ADVANCING A WORLD TOGETHER EQUITABLY, WHICH EXPLORES EXISTING MECHANISMS THAT ASSERT EQUITY AS A PRIORITY AND ANALYZED HOW THEY COULD BE INCORPORATED INTO A TREATY. FORM 990, PART VI, SECTION A, LINE 1A THE BOARD HAS AN EXECUTIVE COMMITTEE, WHICH CAN MAKE DECISIONS ON BEHALF OF THE BOARD (WITH SOME EXCEPTIONS) IN BETWEEN BOARD MEETINGS. FORM 990, PART VI, SECTION B, LINE 11B PRIOR TO THE SUBMISSION OF THE FOUNDATION FOR NIH'S FORM 990 TO THE INTERNAL REVENUE SERVICE, EACH VOTING MEMBER OF THE BOARD OF DIRECTORS SHALL BE PROVIDED WITH A COPY OF THE DRAFT FORM 990 AS APPROVED BY THE CHIEF FINANCIAL OFFICER. FORM 990, PART VI, SECTION B, LINE 12C DIRECTORS, OFFICERS AND EMPLOYEES ARE REQUIRED TO ANNUALLY SIGN A STATEMENT WHICH AFFIRMS THAT THEY HAVE: O RECEIVED A COPY OF THE CONFLICT OF INTEREST POLICY O READ, UNDERSTOOD AND AGREED TO COMPLY WITH THE POLICY O RECEIVED AND REVIEWED A LISTING OF CORPORATE AND FOUNDATION DONORS, CONTRACTORS, VENDORS, GRANTEES, PRINCIPAL INVESTIGATORS AND FINANCIAL INSTITUTIONS WITH WHOM THE FNIH HAS A CURRENT RELATIONSHIP O NO ACTUAL OR APPARENT CONFLICTS OF INTEREST OTHER THAN THOSE DISCLOSED IN THE STATEMENT. THEY MUST ALSO MAKE CERTAIN NOTIFICATIONS IN PARTICULAR CIRCUMSTANCES. THE CONFLICT OF INTEREST POLICY ALSO HAS MECHANISMS FOR HANDLING SUCH CONFLICTS. FORM 990, PART VI, SECTION B, LINE 15 THE COMPENSATION COMMITTEE OF THE BOARD REVIEWED AND CONCURRED WITH THE CEO'S DECISIONS ESTABLISHING AND ADJUSTING THE SENIOR EXECUTIVE TEAM'S ANNUAL SALARIES AND RELATED COMPENSATION DECISIONS. THE COMPENSATION COMMITTEE ALSO APPROVED THE COMPENSATION LEVEL OF THE CEO AND RELATED COMPENSATION DECISIONS. FORM 990, PART VI, SECTION C, LINE 19 ALL SUCH DOCUMENTS ARE AVAILABLE UPON REQUEST. IN ADDITION, THE GOVERNING DOCUMENTS AND FINANCIAL STATEMENTS ARE AVAILABLE ON THE FNIH WEBSITE. FORM 990, PART XII, LINE 2C: PROCESS HAS NOT CHANGED FROM THE PRIOR YEAR. FORM 990, PART X, CASH & INVESTMENTS: APPROXIMATELY $122 MILLION OF FNIH'S CASH AND INVESTMENTS ARE INVESTED IN HIGH QUALITY SHORT-TERM FIXED INCOME SECURITIES WHICH ARE COMMITTED TO FNIH'S RESTRICTED ASSETS.