| FORM 990, PART III, LINE 4A, PROGRAM SERVICE ACCOMPLISHMENTS CONTINUED: |
PARTNERSHIP FOR ACCELERATING CANCER THERAPIES (PACT) IMMUNOTHERAPIES TREATMENTS THAT STIMULATE THE BODY'S OWN IMMUNE SYSTEM TO FIGHT CANCER HAVE PROVEN TO BE AN EFFECTIVE AND PROMISING TREATMENT OPTION FOR CERTAIN CANCERS IN RECENT YEARS. YET THESE IMMUNOTHERAPY TREATMENTS DO NOT WORK FOR ALL PATIENTS, AND WE LACK A PRECISE UNDERSTANDING OF WHY. DEVELOPING STANDARDIZED BIOMARKER TESTS TO UNDERSTAND HOW IMMUNOTHERAPIES WORK IN SOME PATIENTS, AND THUS TO PREDICT PATIENT RESPONSES TO TREATMENT, IS URGENTLY NEEDED FOR THESE THERAPIES TO BENEFIT THE MAXIMUM NUMBER OF PEOPLE. PACT, A FIVE-YEAR PUBLIC-PRIVATE RESEARCH COLLABORATION LAUNCHED IN 2019 BY THE NIH, THE FNIH, THE FDA, AND 12 PHARMACEUTICAL COMPANIES AS PART OF THE CANCER MOONSHOT, INTEGRATES THE EXPERTISE OF RESEARCHERS AT FOUR TOP CANCER RESEARCH CENTERS DANA-FARBER CANCER INSTITUTE, STANFORD UNIVERSITY, MD ANDERSON CANCER CENTER, AND MOUNT SINAI MEDICAL CENTER TO DEVELOP THESE ASSAYS AND HARMONIZE THEM FOR USE ACROSS THE CANCER FIELD. TO DATE, PACT RESEARCHERS HAVE ANALYZED OVER 5,000 SAMPLES FROM 12 CLINICAL TRIALS IN DIFFERENT CANCERS AND USED THE RESULTING DATA TO VALIDATE EXISTING ASSAYS ACROSS ALL FOUR LABORATORIES. SIX EXISTING ASSAYS COMMONLY USED IN ASSESSING IMMUNOTHERAPIES AND COMBINATION THERAPIES ACROSS 15 DIFFERENT CANCERS HAVE BEEN HARMONIZED TO DATE. THE RESULTING STANDARDS HAVE BEEN PUBLISHED IN FOUR MAJOR JOURNAL ARTICLES TO MAKE SURE THESE TESTS CAN BE PERFORMED UNIFORMLY IN LABORATORIES ACROSS THE U.S. AS DATA ANTICIPATED FROM AN ADDITIONAL 35 TRIALS BECOMES AVAILABLE, PACT RESEARCHERS WILL BE ABLE TO USE IT TO HELP DEVELOP NEW BIOMARKERS TO HELP PHYSICIANS SELECT THE MOST OPTIMAL IMMUNOTHERAPY TREATMENTS FOR THEIR PATIENTS. MUCOSAL HEALING FOR ULCERATIVE COLITIS IN APRIL 2021, THE FNIH BIOMARKERS CONSORTIUM LAUNCHED ITS MUCOSAL HEALING IN ULCERATIVE COLITIS (UC) PROJECT TO IMPROVE DIAGNOSIS AND TREATMENT OF A DEBILITATING INFLAMMATORY BOWEL DISEASE THAT AFFECTS MORE THAN THREE MILLION PEOPLE WORLDWIDE. THIS THREE-YEAR INITIATIVE AIMS TO GENERATE BEST PRACTICES AND CONSENSUS STANDARDS FOR ASSESSING DISEASE ACTIVITY AT THE TISSUE-LEVEL IN UC CLINICAL TRIALS. THE PROGRAM ALSO HOPES TO DEVELOP CUTTING-EDGE METHODOLOGIES TO MEASURE MUCOSAL HEALING THE BODY'S ABILITY TO RESTORE INTESTINAL LINING DAMAGED BY UC, AND AN IMPORTANT OUTCOME IN CLINICAL TRIALS MORE ACCURATELY IN THE FUTURE. CREATING A MORE PRECISE MEASURE WITH WHICH TO JUDGE THE OUTCOME OF CLINICAL TRIALS PROMISES TO MEANINGFULLY ACCELERATE THE DEVELOPMENT OF NEW THERAPIES FOR PATIENTS WITH UC. THE ABILITY TO USE A COMMON PROTOCOL AND AUTOMATE THE EVALUATION OF MUCOSAL INFLAMMATION AND HEALING WILL ENABLE THESE MEASUREMENTS TO BE APPLIED MORE CONSISTENTLY, PRECISELY, AND RAPIDLY AND MAY REDUCE THE NUMBER OF BIOPSIES NEEDED. THE GOAL IS TO ADVANCE PHYSICIANS' ABILITY TO HELP GUIDE APPROPRIATE TREATMENT TO REDUCE OR EVEN PREVENT RELAPSES AND COMPLICATIONS, IMPROVING THE PATIENT EXPERIENCE. GENECONVENE IN THE MIDST OF AN ALREADY-STALLED GLOBAL STRUGGLE AGAINST MALARIA, COVID-19-RELATED DISRUPTIONS TO HEALTH CARE SYSTEMS PROMPTED A DANGEROUS RESURGENCE OF THIS DEADLY DISEASE IN 2020. RECOGNIZING THE URGENT NEED FOR NEW STRATEGIES, IN MAY 2021 THE WORLD HEALTH ORGANIZATION (WHO) WITH SUPPORT FROM FNIH'S GENECONVENE GLOBAL COLLABORATIVE PUBLISHED AN UPDATED GUIDANCE FRAMEWORK TO INFORM RESEARCH AND DEVELOPMENT OF GENETICALLY MODIFIED MOSQUITOES. MODIFYING THE GENES OF MALARIA-CARRYING MOSQUITOES CAN REDUCE THEIR ABILITY TO REPRODUCE, SO THAT THERE ARE FEWER TO SPREAD THE DISEASE, AND MAY DECREASE THE MOSQUITOES' ABILITY TO TRANSMIT THE MALARIA PARASITE. IF PROVEN SAFE, EFFECTIVE, AND AFFORDABLE, THESE TECHNOLOGIES COULD OFFER A GAME-CHANGING ADDITION TO THE EXISTING ARSENAL OF INTERVENTIONS AGAINST MALARIA. BUT THERE ARE MANY IMPORTANT QUESTIONS FOR DECISION MAKERS TO ADDRESS WHEN EVALUATING WHETHER AND HOW TO MOVE FORWARD WITH RESEARCH AND IMPLEMENTATION. THE FNIH-LED GENECONVENE INITIATIVE WORKS TO ENSURE THAT ALL STAKEHOLDERS INCLUDING RESEARCHERS, POLICYMAKERS, REGULATORS, AND COMMUNITIES AFFECTED BY MALARIA ARE EQUIPPED WITH THE RIGHT TOOLS TO MAKE INFORMED, RESPONSIBLE DECISIONS ABOUT THESE TECHNOLOGIES. THE NEW WHO GUIDANCE IS A SIGNIFICANT MILESTONE IN THIS EFFORT. IT PROVIDES ANSWERS TO SOME OF THE TOUGHEST QUESTIONS IN THE FIELD, INCLUDING: - HOW CAN THE POTENTIAL EFFECTIVENESS AND RISKS OF GENETICALLY MODIFIED MOSQUITOES ON REDUCING DISEASE BE EVALUATED? - WHAT ARE THE KEY ETHICAL CONSIDERATIONS? - WHICH REGULATORY FRAMEWORKS WILL OVERSEE DECISIONS ABOUT RESEARCH? LIKE MANY OTHER FNIH COLLABORATIONS, GENECONVENE CENTERS ON A CRITICAL INFLECTION POINT WHERE ADVANCES IN BIOMEDICAL RESEARCH DEPEND ON BRINGING DIVERSE GROUPS TOGETHER TO PURSUE A COMMON GOAL. WITH MALARIA CAUSING MORE THAN 600,000 DEATHS WORLDWIDE IN 2020 ALONE, THERE IS AN URGENT NEED TO EVALUATE THE PROMISE OF GENETICALLY MODIFIED MOSQUITOES BOTH QUICKLY AND RESPONSIBLY. GENECONVENE ALSO SERVES AS A GLOBAL HUB FOR RELEVANT, TIMELY AND ACCURATE KNOWLEDGE. A KEY RESOURCE FOR THIS WORK IS THE GENECONVENE VIRTUAL INSTITUTE, ALSO LAUNCHED IN 2020. THE VIRTUAL INSTITUTE IS AN ONLINE LIBRARY HOUSING SCHOLARLY LITERATURE, POLICY PAPERS, OPINION PIECES, EDUCATIONAL VIDEOS AND MEDIA COVERAGE. GENECONVENE ALSO HOSTS REGULAR WEBINARS THAT PROVIDE DIVERSE, MULTIDISCIPLINARY PERSPECTIVES ON THE SCIENTIFIC, SOCIAL AND ETHICAL DIMENSIONS OF GENETIC BIOCONTROL TECHNOLOGIES. REALIZING THE IMMENSE PROMISE OF GENETIC BIOCONTROL RESEARCH TO END MALARIA AND OTHER MOSQUITO-BORNE DISEASES OVER THE LONG TERM WILL REQUIRE A RIGOROUS EVALUATION OF THE RISKS AND BENEFITS OF EACH STEP ALONG THE WAY, FROM THE LABORATORY TO FIELD TESTING TO POTENTIAL IMPLEMENTATION. THROUGH THE GENECONVENE GLOBAL COLLABORATIVE, FNIH IS COMMITTED TO ENSURING THAT EVERYONE CHARGED WITH MAKING DECISIONS ABOUT GENETIC BIOCONTROLFROM SCIENTISTS TO POLICYMAKERS TO COMMUNITIESHAS THE KNOWLEDGE THEY NEED TO MOVE FORWARD SAFELY AND ETHICALLY. GENE DRIVE RESEARCH FORUM HUNDREDS OF PARTICIPANTS AROUND THE WORLD JOINED A 2021 SERIES OF VIRTUAL DISCUSSIONS COHOSTED BY GENECONVENE AND MCMASTER UNIVERSITY IN ONTARIO, CANADA, TO EXPLORE CRITICAL ETHICAL QUESTIONS RELATED TO GENE DRIVE. TOPICS INCLUDED THE ETHICAL PRINCIPLES THAT SHOULD GOVERN GENE DRIVE RESEARCH, AND JUSTICE AND EQUITY CONSIDERATIONS FOR APPLYING GENE DRIVE AT THE LOCAL COMMUNITY LEVEL. THE GENE DRIVE RESEARCH FORUM ORGANIZED BY GENECONVENE DEVELOPED THESE PANELS, AS WELL AS A COMPANION SERIES COHOSTED BY GENECONVENE AND THE GENETIC BIOCONTROL OF INVASIVE RODENTS (GBIRD) PARTNERSHIP THAT FOCUSED ON BEST PRACTICES FOR ENGAGING STAKEHOLDERS TO EXPLORE GENE DRIVE TECHNOLOGIES TOGETHER. COMPREHENSIVE CELLULAR VACCINE IMMUNE MONITORING CONSORTIUM (CCVIMC) IN JULY 2021, THE GATES FOUNDATION RENEWED FOR ANOTHER FIVE YEARS THE REMARKABLE WORK OF THE FNIH COMPREHENSIVE CELLULAR VACCINE IMMUNE MONITORING CONSORTIUM (CCVIMC). FOCUSED ON SUPPORTING THE DEVELOPMENT OF AN EFFECTIVE VACCINE FOR THE HIV VIRUS THAT CAUSES AIDS, THE CCVIMC CONVENES LEADING SCIENTISTS ACROSS THE GLOBE TO PROVIDE STANDARDIZED MEASUREMENTS FROM CLINICAL AND PRE-CLINICAL STUDIES OF THE DISEASE AND SHARE DATA TO OPTIMIZE VACCINE PLATFORMS BEING DEVELOPED THROUGH THE COLLABORATION FOR AIDS VACCINE DISCOVERY. GLOBALLY 1.5 MILLION PEOPLE ARE INFECTED WITH HIV ANNUALLY. OVER THE NEXT FIVE YEARS THE CCVIMC WILL CONTINUE TO BUILD ON RESEARCH ENABLING NEW APPROACHES TO HIV VACCINES TO BE STUDIED. THE END GOAL IS DEVELOPMENT OF A SAFE AND BROADLY EFFECTIVE VACCINE THAT WILL PREVENT HIV INFECTION. |
| 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 A, LINE 2 |
MARIA FREIRE, THE FNIH PRESIDENT AND EXECUTIVE DIRECTOR UNTIL SEPTEMBER 2021, IS A NON-EXECUTIVE MEMBER OF THE BOARD OF DIRECTORS OF ALEXANDRIA REAL ESTATE. JOEL MARCUS IS THE CHAIRMAN AND CEO OF ALEXANDRIA REAL ESTATE AND A NON-EXECUTIVE MEMBER OF THE FNIH BOARD OF DIRECTORS. |
| FORM 990, PART VI, SECTION A, LINE 4 |
THE FNIH BY-LAWS WERE AMENDED IN MAY 2021 TO MAKE CHANGES TO THE TERMS OF MEMBERS OF THE BOARD OF DIRECTORS. |
| 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 PRESIDENT AND EXECUTIVE DIRECTOR'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 PRESIDENT AND EXECUTIVE DIRECTOR 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. |
Attach to Form 990 or 990-EZ.