>>WELCOME TO THE OPEN SESSION OF THE 202nd MEETING OF THE ALLERGY AND INSPECTION ANXIOUS DISEASE. AS YOU KNOW, DURING THE OPEN SESSIONS WE'RE JOINED FROM PROFESSIONAL AND LAY ORGANIZATION WHO'S SHARE INTEREST AND ACTIVITIES IN COMMON WITH THE MISSION OF THE INSTITUTE. WE WELCOME THEM, AS ALWAYS, AND I'D LIKE TO ALSO WELCOME TWO AD HOC DAIT COUNCIL MEMBERS WHO ARE JOINING US TODAY. Dr. DAVID ARTIST IS THE MICHAEL KORS PROFESS OF IMMUNOLOGY IN THE DEPARTMENT OF MEDICINE WITH THE CORNELL MEDICAL COLLEGE AND Dr. DEB ROSS KEY HERMIGHT FR IMMUNEEL GE AND PATHO BIOLOGY. WE ARE DELIGHTED TO HAVE THESE TWO AD HOC MEMBERS WITH US TODAY. COUNCIL MEMBERS Dr. LINDA BAKKENSTED IS UNABLE TO BE WITH US TODAY. WITH REGARD TO THE MINUTES, THE FIRST ITEM OF BUSINESS IS TO REVIEW AND APPROVE THE MINUTES FROM THE LAST MEETING. YOU SHOULD ALREADY HAVE SEEN A COPY OF THE MINUTES IN THE ELECTRONIC COUNCIL BOOK. ARE THERE ANY CORRECTIONS TO THE MINUTES? DOES ANYONE HAVE ANY QUESTIONS OR CONCERNS ABOUT THE CONCEPTS PRESENTED AT THE PREVIOUS MEETING? IF NOT, MAY I HAVE A MOTION FOR APPROVAL? IS THERE A SECOND? ALL IN FAVOR OF THE MINUTES, PLEASE A AYE. ANY OPPOSED? THE MINUTES STAND AS APPROVED. NOW, LET'S GET ON WITH THE FORMAL REMARKS TO THE COUNCIL. PRESIDENT JOE BIDEN HAS NOMINATED Dr. ARATI PRABHAKAR TO SERVE AS THE DIRECTING OFF THE OF THE WHITE HOUSE OFFICE OF SCIENCE OF THE OSTP. ONCE CONFIRMED TO THIS POSITION, SHE ALSO WOULD SERVE AS ASSISTANT TO THE PRESIDENT FOR SCIENCE AND TECHNOLOGY AS IS CHIEF ADVISER THE SCIENCE AND TECHNOLOGY, SHE WOULD BE A CABINET MEMBER. THE SENATE CONFIRMATION PROCESS FOR HER NOMINATION, IS CURRENTLY UNDERWAY. SHE, A HIGHLY RESPECTED ENGINEER AND APPLIED PHYSICIST, SERVED IN PREVIOUS ADMINISTRATIONS AS DIRECTOR OF TAP ADDRESS AND TECHNOLOGY AND THE DEFENSE ADVANCED RESEARCH PROJECT AGENCY OR. THE ADMINISTRATION ANNOUNCED THE APPOINTMENT OF THE SEASON EMERGENCY MANAGEMENT LEADER ROBERT FENTON UNION AS THE WHITE HOUSE NATIONAL MONKEYPOX COORDINATOR. Dr. DEMETRE DASKALAKIS, A HELPER THE CDC DIVISION OF HIV PREVENTION WAS NAMED THE DEPUTY COORDINATOR. THE STRATEGIC AND OPERATIONAL RESPONSE TO THE MONKEYPOX OUTBREAK IS NOW BEING LED BY THESE TWO INDIVIDUALS WITH DECADES OF RELEVANT AND COMPLIMENTARY EXPERIENCE, Mr. FENTON SERVED AS ACTING FEMUR ADMINISTRATOR AND LED MULTIPLE CHALLENGING OPERATIONS THROUGHOUT HIS CAREER. PRIOR TO JOINING THE CDC, Dr. DASKLAAKIS OVER AWE INFECTIOUS DISEASE MANAGEMENT FOR THE DEPARTMENT OF HEALTH AND MENTAL HYGIENE IN NEW YORK CITY. BOTH PLAYED CRITICAL ROLES IN MAKING COVID-19 VACCINES MORE ACCESSIBLE TO UNDERSERVED COMMUNITIES. IN JULY, FDA COMMISSIONER, Dr. ROBERT KAYLORA ANNOUNCED THE SELECTION OF TWO OUTSTANDING PROFESSIONALS TO FILL IMPORTANT SENIOR LEADERSHIP POSITIONS AT THE AGENCY. Dr. BUMPIS WHO SERVED AS DIRECTOR OF THE DEPARTMENT OF MOLECULAR SCIENCES AND PHARMACOLOGY AT THE JOHNS HOPKINS SCHOOL OF MEDICINE IS THE NEW FDA CHIEF SCIENTIST. Dr. HILARY MARSTON A HIGHLY-VALUED COLLEAGUE, WHO PREVIOUSLY SERVED IN MY OFFICE AS MEDICAL OFFICER AND POLICY ADVISER FOR GLOBAL HEALTH AND MOST RECENTLY AS THE WHITE HOUSE SENIOR POLICY ADVISER ON COVID-19, IS NOW THE CHIEF MEDICAL OFFICER AT FDA. PRESIDENT JOE BIDEN HAS SELECTED Dr. MONICA BERKTECHNOLI AS A CLINICIAN AND AN EXECUTIVE AS THE NEXT DIRECTOR IN THE FIRST WOMAN TO LEAD THE NATIONAL CANCER INSTITUTE. CURRENTLY, Dr. BERT AGO KNOWLEDGE' IS THE RICHARD E. WILLIAM PROFESSOR OF SURGERY AT HARVARD MEDICAL SCHOOL AND SHE HOLD POSITIONS AT BRIGHAM. SHE WILL TAKE OVER THE REIGNS FROM Dr. DOUG LOWY WHO HAS BEEN SERVING AS ACTING NIH/NCI DIRECTOR SINCE FORMER NCI DIRECTOR Dr. NED SHARPLESS STEPPED DOWN LAST SPRING. IN JUNE, ACTING NIH DIRECTOR Dr. LARRY TABAK ANNOUNCED THE SELECTION OF KEVIN WILLIAMS AS THE DIRECTOR OF THE NIH OFFICE OF EQUITY, DIVERSITY AND INCLUSION OR EDI. KEVIN JOINS NIH FROM THE U.S. FEDERAL TRADE COMMISSION WHERE HE MOST RECENTLY HELD A POSITION OF DEPUTY EXECUTIVE DIRECTOR. HE WILL GUIDE THE STRATEGIC DIRECTION FOR NIH ON ALL INCERTAINAL EDI MATTERS. LET ME DIGRESS TO BRING YOU UP-TO-DATE ON NIAID ACTIVITIES IN THIS AREA. MANY OF YOU MAY BE AWARE OF EFFORTS ACROSS THE NIH TO ENHANCE DIVERSITY, EQUITY, INCLUSION AND ACCESSIBILITY OR DEIA. IN CARRYING OUT OUR MISSION, NIAID IS COMMITTED TO FOSTERING A WORKPLACE THAT EMBODIES AND VALUES THE DIVERSE STAFF. THE FUNDS IN EXTRA RESEARCH PORTFOLIO INCLUSIVE OF THE VARIOUS POPULATIONS IT SERVICE AND THAT PRIORITIZES HEALTH EQUITY IN ALL RESEARCH THAT NIAID CONDUCTS AND SUPPORTS. AS PART OF THIS COMMITMENT, NIAID HAS ESTABLISHED AN INTERNAL DEIA COUNCIL ADVISING OUR LEADERSHIP ON MANY OF THESE ACTIVITIES GOING FORWARD. TO GATHER INFORMATION FROM AN EXTRAMURAL COMMUNITY TO ENHANCE DEIA ACROSS NIAID ACTIVITIES, WE'LL BE ISSUING A REQUEST FOR INFORMATION THIS FALL. THE RFI IS INTENDED TO INFORM US OF POTENTIAL APPROACHES TO ADVANCE DEIA AND TO ENSURE THAT ALL AVAILABLE PERSPECTIVES ARE CONSIDERED AS NIAID DEVELOPS AND IMPLEMENTS DEIA STRATEGIES. WE ENCOURAGE THE EXTRAMURAL RESEARCH COMMUNITY TO SHARE YOUR THOUGHTS WITH US IN THIS IMPORTANT DISCUSSION. NOW LET ME GET BACK TO A FEW MORE PERSONNEL UPDATES. THE DIVISION OF EXTRAMURAL ACTIVITIES SELECTED EILEEN LOUIS AS A NEW BRANCH CHIEF IN THE OFFICE OF ACQUISITIONS. SHE WILL OVERSEE RESEARCH CONTRACTS, BRANCH B. AND HER EXPERIENCE HAS CONTRACT MANAGEMENT ACQUISITION AND SPANS MORE THAN 28 YEARS. INITIALLY, AS A PRIVATE SECTOR CON TRACKER TO THE OFFICE OF NAVAL RESEARCH, SHE JOINED THE NIAID DEA OFFICE OF ACQUISITIONS IN 2011. NIAID WELCOMES TWO NEW BRANCH CHIEFS TO JOINS THE TECHNOLOGY TRANSFER AND INTELLECTUAL PROPERTY OFFICE. Dr. COSSEY MAFUDA IS THE TIP AND Dr. CHATTERJEE IS THE NEW CHIEF OF THE BRANCH B. COSMO SERVED AS THE DIRECTOR OF THE OFFICE OF PARTNERSHIP AND BUSINESS DEVELOPMENT AT THE NATIONAL MEDICAL RESEARCH CENTER. PREVIOUSLY, HE WAS A PATENT AND LICENSING CONSULTANT IN THE FDA TECHNOLOGY TRANSFER PROGRAM AND A PATENT IN LICENSING OFFICER AT THE UNIVERSITY OF MARYLAND, BALTIMORE. Dr. CHATTERJEE CAME TO NIAID FROM THE NCI. HE WAS A MEMBER OF THE LEADERSHIP TEAM AND THE TECHNOLOGY TRANSFER CENTER AND SERVED AS THE UNIT SUPERVISOR FOR TECHNOLOGY TRANSFER OPERATIONS NOT ONLY OF NCI AND ALSO OF OTHER NIH ENTITIES. FINALLY, WE ARE PLEASED TO WELCOME BACK TO NIAID STEPHANIE HIXSON, THE NEW DIRECTOR OF OUR OFFICE OF WORKPLACE SOLUTIONS. STEPHANIE FILLS THE POSITIONS LEFT BY THE RETIREMENT OF JUDY YAS KNEE LATE LAST YEAR. STEPHANIE CAME TO NIH FROM HER POSITION AS SENIOR DIRECTOR OF REAL ESTATE AND CONSTRUCTION SHE PROVIDED 15 YEARS OF DEDICATED SERVICE TO NIH, INCLUDING, MANAGING THE DESIGN AND ACTIVATION OF NIAID'S ON CAMPUS BIO CONTAINMENT RESEARCH BUILDING AND MANAGING THE NIAID'S BSL4 MRI IMAGING FACILITY. THROUGHOUT THE YEAR, NIAID HOSTS MANY INTERNATIONAL DELEGATIONS WITH WHICH I, AND OTHER STAFF MEMBERS, MEET. DURING THE LAST FEW MOVES WE HAVE COORDINATED VIRTUAL AND IN-PERSON MEETINGS WITH VISITORS FROM THE UNITED ARAB EMIRATES, GERMANY, ITALY, EUROPE, SOUTH KOREA AND THE UNITED KINGDOM. THIS SLIDE HIGHLIGHTS JUST A FEW OF THESE MEETINGS. PICTURED IN THE UPPER-LEFT OF THE SLIDE IS PROFESSOR CHRIS WHITTY THE CHIEF MEDICAL OFFICER FOR ENGLAND. WE'VE HAD SEVERAL REGULARLY-SCHEDULED RECENT EXCHANGES TO DISCUSS COVID-19 RESEARCH AND CHALLENGES AS WELL AS THE MONKEYPOX OUTBREAK. IN THE UPPER-RIGHT OF THE SLIDE, I AM PICTURED GREETING Dr. HANCE KLUGE THE WHO REGIONAL DIRECTOR FOR EUROPE DURING HIS VISIT TO WASHINGTON IN EARLY DOUG. HE AND I DISCUSSED COVID-19 READINESS FOR THE FALL, MONKEYPOX AND OTHER TOPICS. IN THE LOWER-RIGHT AREA OF THE SLIDE, I AM PICTURED WITH A DELEGATION OF SENIOR UAE HEALTH OFFICIALS. NIAID STAFF FROM OUR INTRAMURAL PROGRAM AND THE VRC JOINED ME IN DISCUSSING WITH THEM COLLABORATIVE ACTIVITIES INCLUDING A JOINT GRANT PROGRAM THAT WE ARE CO FUNDING WITH UAE INSTITUTIONS. THE PHOTO IN THE LOWER-LEFT AREA OF THE SLIDE SHOW A VIRTUAL MEETING I ATTENDED JUNE 3 JUNE 30th WITH THE GERMAN MINISTER OF HEALTH Dr. KARL LAUTERBACH AND Dr. SAHIN AS WELL AS THE WHITE HOUSE CORONAVIRUS RESPONSE COORDINATOR Dr. JHA TO DISCUSS THE SCIENTIFIC EVIDENCE FOR GUIDING VACCINES SELECTION FOR THE FALL IMMUNIZATION CAMPAIGN. ON JULY 8th, WE ENTERED INTO A AGREEMENT WITH . TECHNOLOGY COMPANY BASED IN CAPE TOWN, SOUTH AFRICA. THE MRNA VACCINE CENTER OF EXCELLENCE AND TRAINING OR THE TECHNOLOGY TRANSFER HUB PART OF AN EFFORT LED BY W.H.O. TO BUILD CAPACITY IN LOW AND MIDDLE INCOME COUNTRIES TO MAKE mRNA VACCINES. THE MUTUALLY BENEFICIAL COLLABORATION WILL ENABLE SCIENTISTS AT THE NIAID/VRC AND AFRIGEN TO SHARE KNOWLEDGE, EXPERTISE AND DATA ON mRNA PRODUCTION PROCESSES TO SUPPORT THEIR RESPECTED MISSIONS FOR THE VRC TO PRODUCE VACCINES FOR EARLY-STAGE CLINICAL TRIALS AND FOR AFRIGEN TO MANUFACTURE VACCINES AT SCALE. NOW, I WOULD LIKE TO TAKE A FEW MINUTES TO UPDATE YOU ON THE NIH BUDGET. AS YOU MAY RECALL AT OUR LAST MEETING, I UPDATED YOU ON THE FISCAL 2023 PRESIDENT'S BUDGET RELEASED ON MARCH 28th. SINCE THEN, THE HOUSE AND SENATE HAVE BOTH RELEASED DRAFT BUDGETS FOR NIH. THE OVER ALL PROPOSAL INCREASED FOR NIH IN THE BOTTOM-MIDDLE OF THE SLIDE IS 5.5% UNDER THE HOUSE BILL, AND 6.6% ON THE RIGHT LOWER PANEL FOR THE SENNAL BILL WITH MOST INSTITUTES RECEIVING AN INCREASE OF 2% ON BOTH BILLS. NOTABLY, THE HOUSE BILL PROPOSES LARGER FUNDING INCREASES THAN MOST INSTITUTES INCLUDING THE NIAID. THE HOUSE AND SENATE BILLS HAVE A DIFFERENT STRATEGY FOR FUNDING THE ADVANCED RESEARCH PROJECTS AGENCIES FOR HEALTH OR ARPA-H. THIS IS AN INITIATIVE CREATE TODAY SPEED TRANSFORMATION IN THE HEALTH RESEARCH AND THE APPLICATION AND IMPLEMENTATION OF HEALTH BREAKTHROUGHS. UNDER THE HOUSE BILL, ARPA-H WOULD RESIDE OUTSIDE OF THE NIH, SPECIFICALLY WITHIN THE HHS OFFICE OF THE SECRETARY WITH AN INITIAL BUDGET OF $2.75 BILLION. THE SENATE BILL INCORPORATES ARPA-H WITHIN NIH WITH A BUDGET OF $1 BILLION. THE CONFERENCE COMMITTEE IS IN THE PROCESS OF IRONING OUT THE DIFFERENCES CONTAINED IN THE HOUSE VERSUS THE SENATE BILLS BEFORE IT SENDS THE BUDGET PACKAGE TO THE PRESIDENT FOR HIS SIGNATURE. GIVEN WHERE WE ARE IN THE BUDGET PROCESS, WE EXPECT TO BEGIN FISCAL '23 UNDER A CONTINUING RESOLUTION OR A CR. THIS IS NOTHING NEW. WE HAVE BEGUN THE FISCAL YEAR UNDER CR EVERY FISCAL YEAR SINCE 1998. UNTIL A FINAL FY23 BUDGET IS PASSED, WE WILL MAINTAIN A CONSERVATIVE POSTURE IN SETTING PAY LINES AND PROGRAM LEVELS SO WE MAINTAIN THE FLEXIBILITY TO ADJUST PROGRAMS TO EFFECTIVELY OPERATE WITHIN THE FINAL BUDGET LEVEL WHICH WE DO NOT ME AT THIS POINT. THIS SLIDE SHOWS THE NIAID FINANCIAL MANAGEMENT PLAN FOR THE FISCAL '23 BUDGET. OUR RO1 PAYLINES FOR ESTABLISHED AND NEW P.I.s ARE AT THE TENTH . COMPETING UNSOLACATED AWARDS AS WELL AS NON COMPETING GRANTS AND RND AWARDS WILL INCUR NEW PROBLEMATIC ADJUSTMENTS AND COMPETING RESEARCH INITIATIVES HAVE BEEN CUT BY UP TO 20% TO SUSTAINED NEW INVESTIGATOR INITIATED AWARDS. WE ESTIMATE THAT OVER ALL SUCCESS RATES WILL BE 18 TO 22% SIMILAR TO THAT OF 2022. NOW AN IMPORTANT ASPECT OF OUR APPROPRIATION IS TO SUMMARIZE THE PREPORTION THAT CONGRESS HAS EARMARKED FOR NIAID TO SPEND ON SPECIFIC DISEASE AREAS. WE APPRECIATE THE ADDITIONAL FUNDING. HOWEVER, EARMARKS LIMIT OUR FLEXIBILITY TO SUPPORT INVESTIGATOR-INITIATED PROJECT AND OTHER IMPORTANT NIAID RESEARCH PRIORITIES. THE ATTACHED TABLE SHOWS THE COMPONENTS OF OUR BASE AND EARMARKED BUDGETS FROM FISCAL 2022 COMPARED TO PROPOSES IN THE HOUSE AND SENATE BILLS FOR FISCAL '23. BOTH THE HOUSE AND SENATE BILLS PROPOSE INCREASING THE EARMARKS ALLOCATIONS FOR ANTIMICROBIAL RESISTANCE AND RESOURCE AND VACCINES. THEY MAINTAIN THE SAME BUDGET ALLOCATIONS FOR 23 REGIONAL BIO CONTAINMENT LABS THAT WE INITIALLY FUNDED IN FISCAL 2003 TO PREVENT, PREPARE FOR AND RESPOND TO INFECTIOUS DISEASES OUTBREAKS. THE HOUSE BILL ALSO PRIORITIZES FUNDING TO SUPPORT THE CONSORTIUM OF FOOD ALLERGY RESEARCH AND HEALTH DISPARITIES RESEARCH. AS I NOTED BEFORE, WE WILL HAVE TO WAIT UNTIL THE HOUSE AND SENATE RESOLVE DIFFERENCES CONTAINED IN THEIR BILLS TO SEE THE FINAL PREPORTION OF FUNDING DIRECTED TO EARMARKS. NOW, LET ME TAKE A FEW MOMENTS TO BRIEFLY SUMMARIZE FUNDING PROVIDED TO NIAID TO RESPOND SPECIFICALLY TO THE COVID-19 PANDEMIC AND CORONAVIRUSES. THE TOP HALF OF THE TABLE RECAPS FUNDING BY NIAID AND THE NIH SINCE MARCH OF 2020 THROUGH FOUR SUPPLEMENTAL APPROPRIATIONS. THESE FUNDS ARE AVAILABLE TO USE UNTIL SEPTEMBER THE 30th, 2024. NIAID'S $1.5 BILLION IN FUNDING SUPPORTS A BROAD ARRAY OF INTRAMURAL AND EXTRAMURAL RESEARCH TO IMPROVE OUR FUNDAMENTAL UNDERSTANDING OF SARS-CoV-2, AND COVID-19 DISEASE PROGRESSION, OUTCOMES, RECOVERY, AND TO ADVANCE THE DEVELOPMENT OF SAFE AND EFFECTIVE VACCINES, THERAPEUTICS AND DIAGNOSTICS. WE HAVE AWARDED OR COMMITTED MORE THAN 95% OF THESE FUNDS. NIH IS $3.3 BILLION IN ADDITION TO COMPLIMENTING OUR ACTIVITIES INCLUDES $1.9 BILLION TO ADVANCE RESEARCH TO DEVELOP AND VAL DADE NEW AS SAYS AND RETOOL EXISTING DIAGNOSTIC PLATFORMS THROUGH PROGRAMS SUCH AS THE RAPID ACCELERATION OF RADX ALSO INCLUDED IN THE $3.3 BILLION IS $1.15 BILLION FOR NIH TO SUPPORT RESEARCH INTO THE PROLONGED HEALTH CONSEQUENCES OF SARS-CoV-2 INFECTION OR ALSO KNOWN AS LONG-COVID. THE BOTTOM HALF OF THE TABLE NOTES FUNDING PROVIDED TO DATE BY THE HHS OFFICE OF THE SECRETARY TO NIAID TO EXECUTE NIH'S ACCELERATING COVID-19 THERAPEUTIC INTERVENTIONS AND VACCINES OR ACTIVE PARTNERSHIP. ACTIVE WORKS WITH THE HHS COORDINATION OPERATIONS AND A RESPONSE ELEMENT OR H-CORE PREVIOUSLY KNOWN AS COUNTERMEASURES ACCELERATION GROUP AND OPERATION WARP SPEED. WE DO THIS TO COORDINATE THE GOVERNMENT'S PANDEMIC RESPONSE AND INTERACT WITH THE PRIVATE SECTOR TO ACCELERATE THE DEVELOPMENT, MANUFACTURING AND DISTRIBUTION OF COVID-19 VACCINES, THERAPEUTICS AND DIAGNOSTICS. THE $2.5 BILLION FOR NIAID INCLUDES SUPPORT FOR PHASE 3 CLINICAL TRIALS OF FIVE CANDIDATE VACCINES, AS WELL AS VACCINES STUDIES AND SPECIAL POPULATIONS. FUNDING ALSO SUPPORTS CLINICAL TRIALS TO EVALUATE COVID-19 THERAPEUTICS AND INCLUDING THE ACT OF TWO STUDY AND ADAPTIVE TRIAL TESTING INVESTIGATIONAL AGENTS AND NON HOSPITALIZED ADULTS WITH MILD TO MODERATE COVID-19 SYMPTOMS. IN ADDITION, THESE FUNDS SUPPORT COMPREHENSIVE REAL-TIME RISK ASSESSMENT OF EMERGING MUTATIONS AND EFFORTS TO RAPIDLY CHARACTERIZE EMERGING VARIANTS AND ACTIVELY MONITORING THE IMPACT ON SARS-CoV-2 VACCINES AND THERAPEUTICS THROUGH THE SARS-CoV-2 ASSESSMENT OF VIRAL EVOLUTION OR SAVE PROGRAM. NIAID HAS INVESTED $0.7 BILLION THROUGH THE AMERICAN RESCUE PLAN TO IMPLEMENT THE ANTIVIRAL PROGRAM FOR PANDEMICS WHICH INCLUDES AWARDING ABOUT $600 MILLION TO NINE ANTIVIRAL DRUG DISCOVERY OR AVID CENTERS AND THESE CENTERS WILL CONDUCT INNOVATIVE, MULTI-DISCIPLINARY RESEARCH TO DEVELOP CANDIDATE COVID-19 ANTIVIRALS AND ESPECIALLY THOSE THAT CAN BE TAKEN IN AN OUT PATIENT SETTING. AS WELL AS ANTIVIRALS TARGETING SPECIFIC VIRAL FAMILIES WITH HYPO TEN SHIGH POTENTIAL TO CAUA PANDEMIC IN THE FUTURE. WE'RE UNCERTAIN ABOUT THE SOURCE OF FUTURE-YEAR FUNDING TO CONTINUE THE ANTIVIRAL PROGRAM FOR PANDEMICS, WE'VE BEEN WORKING ON POTENTIAL FUNDING SOLUTIONS TO SUSTAIN THIS VERY IMPORTANT INITIATIVE. FOR EXAMPLE, A PARTIAL SOLUTION IS THE SEPTEMBER 2nd PROPOSED SUPPLEMENT THE BUDGET TO CONGRESS FOR FISCAL 2023. WHICH INCLUDES $22 BILLION TO OVER ON GOING NEEDS ASSOCIATED WITH THE COVID-19 PANDEMIC. INCLUDED IN THAT PROPOSAL WAS $8 BILLION FOR PROJECT COVID SHIELD, TO DEVELOP AND LICENSE THE VACCINES AND THERAPEUTICS NEEDED TO BETTER ADDRESS THE EMERGENCE OF NEW STRAINS OF SARS-CoV-2. WE WILL NEED TO EVADE FOR CONGRESS TO DELIBERATE THIS REQUEST BUT AS MANY OF YOU HAVE HEARD, THE REPUBLICAN IN CONGRESS HAVE MADE IT CLEAR THEY'RE NOT SYMPATHETIC TO THIS REQUEST FOR SUPPLEMENTAL FUNDING. THIS SLIDE SUMMARIZES THE NIAID BUDGET FOR MONKEYPOX IN FISCAL 2021, 2022 AND 2023. FISCAL 2021 FUNDING REFLECTS NIAID'S PREPAREDNESS EFFORTS TO STUDY HIGH-CONSEQUENCE PATHOGENS IN KEY INTERNATIONAL LOCATIONS WHERE THEY ARE ENDEMIC AND INCLUDES A COLLABORATION WITH THE RESEARCH BIOMEDICAL OF THE DEMOCRATIC REPUBLIC OF THE CONGO OR DRC. WHICH EXPECTS TO SOON BEGIN A DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF THE SAFETY AND THE EFFICACY OF TPOX FOR TREATING ADULT AND PEDIATRIC PATIENTS DIAGNOSIS WITH MONKEYPOX. SINCE MONKEYPOX WAS DECLARED A PUBLIC-HEALTH EMERGENCY IN THE UNITED STATES IN AUGUST, WE HAVE EXPANDED OUR RESEARCH ON THE BIOLOGY AND CLINICAL MANIFESTATIONS OF MONKEYPOX'S INFECTION AS WELL AS STUDIES OF EXISTING AND POTENTIAL INTERVENTIONS TO DIAGNOSE TREAT AND PREVENT MONKEYPOX FISCAL 2022 INVESTMENTS REFLECT THE ABOVE RESEARCH AREAS INCLUDING TWO NOTABLE CLINICAL TRIALS. ONE IS A PHASE 3 RANDOMIZED PLACEBO CONTROL DOUBLE BLIND TRIAL FOR THE TREATMENT OF MONKEYPOX IN OUT PATIENT SETTINGS IN THE UNITED STATES THROUGHOUT AIDS CLINICAL TRIAL GROUP. THE SECOND, SAY CLINICAL STUDY OF GINIOS VACCINE AT LOWER DOSE AND BY A DIFFERENT ROUTES OF INOCULATION IN ADULTS 18 YEARS OF AGE OR OLDER, WHO ARE AT HIGH-RISK FOR MONKEYPOX INFECTION. WE ARE CURRENTLY WORKING WITH THE EXECUTIVE BRANCH ON FORMULATING RESEARCH NEEDS AND IDENTIFYING FUNDING SOURCES FOR FISCAL 2023 MONKEYPOX RESEARCH. NOTE, THAT ON SEPTEMBER 2nd, THE ADMINISTRATION ANNOUNCED ITS FISCAL 2023 SUPPLEMENTAL BUDGET REQUEST OF $4.5 BILLION TO ADDRESS THE CURRENT MONKEYPOX OUTBREAKS INCLUDING IN THAT FIGURE, IS CLOSE TO $200 MILLION TO HHS FOR HIGH-PRIORITY RESEARCH AND DEVELOPMENT. INCLUDING THE EVOLUTION OF VACCINES EFFECTIVENESS IN SPECIAL POPULATIONS AND THE DEVELOPMENT OF RAPID DIAGNOSTIC TESTS. THE BALL IS NOW IN CONGRESS' COURT. NOW LET ME MOVE ON TO DISCUSS SEVERAL ITEMS OF LEGISLATIVE INTERESTS. NIAID-SUPPORTED RESEARCH, INCLUDING OUR EFFORTS TO BETTER UNDERSTAND TREAT AND PREVENT COVID-19 AND POST ACUTE SEE QUELL A OF COVID KNOWN AS LONG-COVID, REMAIN TOPICS OF GREAT INTEREST TO THE CONGRESS. ON JUNE 16th, I TESTIFIED AT A SENATE HEALTH EDUCATION LABOR AND PENSIONS KNOWN AS THE HELP COMMITTEE HEARING ENTITLED "AN UPDATE ON THE ON GOING FEDERAL RESPONSE TO COVID-19 CURRENT STATUS AND FUTURE PLANNING" THE ASSIST APARASSISTANT PREPAREDNEE AND MY COLLEAGUES FROM CDC AND FDA ALSO PARTICIPATED. AS MANY OF YOU ARE AWARE IN JUNE, I TESTED POSITIVE FOR COVID-19, SO I JOINED THE HEARING VIRTUALLY WHILE IN ISOLATION SHOWN HERE DOING ZOOM FROM MY OFFICE. THE HEARING WAS AN IMPORTANT OPPORTUNITY TO DISCUSS SOME OF THE UNIQUE WAYS THE COVID-19 PANDEMIC HAS CHANGED HOW WE LIVE AND WORK AND EMPHASIZING THAT ADDITIONAL EFFORTS ARE NEEDED TO FULLY CURB THE PANDEMIC. THE COMMITTEE WAS ESPECIALLY INTERESTED IN OUR ON GOING EFFORTS TO BETTER UNDERSTAND AND TREAT LONG COVID AS WELL AS OUR PANDEMIC PREPAREDNESS EFFORTS. I SPOKE ABOUT OUR ANTIVIRAL PROGRAM FOR PANDEMIC AND INCLUDING OUR ANTIVIRAL DRUG DISCOVERY CENTERS TO DEVELOP THERAPEUTICS THAT COULD BE UTILIZED DURING A PANDEMIC. I ALSO STRESS THE IMPORTANCE OF INVESTING IN PANDEMIC PREPARED NESTOR ABLE TO QUICKLY RESPONSE TO THE INEVITABLE NEXT THREAT. I WANT TO ACKNOWLEDGE ON THIS BUSY SLIDE, THE NIAID STAFF WHO ARE PARTICIPATE ON MY BEHALF INCLUDING APPROPRIATION STAFF. THESE EVENTS, AS OUTLINED ON THIS SLIDE, HIGHLIGHT THE CONTINUED INTEREST OF CONGRESS IN THE BROADER NIAID RESEARCH PORTFOLIO AS WELL AS OUR EFFORTS TO ADDRESS COVID-19 AND ENHANCE OUR PREPAREDNESS. I WOULD LIKE TO TAKE A MOMENT TO NOW REFLECT ON THE LATE CONGRESSMAN JOHN PORTER. A TREASURED FRIEND OF NIH WHO PASSED AWAY SHORTLY AFTER THE COUNCIL LAST MET IN JUNE CONGRESSMAN PORTER SERVED AS THE U.S. REPRESENTATIVE FOR THE TENTH DIRECTING HE CHAIRED THE SUBCOMMITTEE ON LABOR HEALTH AND HUMAN SERVICES EDUCATION AND RELATED AGENCIES FROM 1995 THROUGH 2000 AND IN THAT ROLE, HE STRESSED ACHIEVING MEDICAL ADVANCES TO IDENTIFY, TREAT AND CONQUER DISEASE REQUIRES SUN PAINT SUPPORT FOR BIOMEDICAL RESEARCH AND NOTABLY, AS CHAIR, OF THE HOUSE LABOR HHS APPROPRIATIONS SUBCOMMITTEE CONGRESSMAN PORTER LED A SUCCESSFUL PUSH TO DOUBLE THE ANNUAL NIH BUDGET. YOU MAY BE AWARE THAT THE PORTER NEUROSCIENCE RESEARCH CENTER ON THE NIH CAMPUS IN BETHESDA IS NAMED IN HIS HONOR IN RECOGNITION OF HIS SUPPORT OF NIH AND ITS MISSION AND WE ARE GRATEFUL FOR CONGRESSMAN PORTER'S STRONG AND SUSTAINED SUPPORT FOR NIH AND HIS BELIEF IN THE TRANSFORMATIVE POWER OF MEDICAL RESEARCH. IT WAS MY IMMENSE HONOR TO WORK WITH CONGRESSMAN PORTER HE IS GREATLY MISSED BY THE NIH COMMUNITY. I WILL DEDICATE THE REMAINDER OF THIS SESSION TO A DISCUSSION YOU'VE ISSUES THAT HAVE ARISEN AND EVENTS THAT HAVE OCCURRED AND FOLLOW UPS OF MATTERS WE HAVE PREVIOUSLY DISCUSSED. FIRST, AN HIV/AIDS UPDATE. THIS SUMMER, WAS THE 21s 21st INTERNATIONAL AIDS CONFERENCE IN MONTREAL WHICH WAS A BOTH I AM PRESENT AND VIRTUAL MEETING. HENCE A HYBRID. THE THEME WAS TO REENGAGE AND FOLLOW THE SCIENCE. THERE WERE MANY NEW AND INTERESTING ISSUES THAT CAME UP, OUR OWN VRC PROGRAM, NEW INSIGHTS INTO IDENTIFYING HIV CELLS AND USING THEM AS POTENTIAL CURE TARGETS. ANOTHER WAS AN INTERESTING NON-AIDS ISSUE. PRESENTED AT THE AIDS MEETING. THIS WAS SUPPORTED BY NIAID DMID SHOWING THAT TAKING ANTIBIOTICS AFTER SEX CUTS CLASSICAL STIs BY GONORRHEA, CHLAMYDIA AND SYPHILIS BY 66% IN MEN WHO HAVE SEX WITH MEN AND TRANSGENDER WOMEN, BOTH LIVING WITH HIV AS WELL AS THOSE ON PREP. AS I MENTIONED TO THE COUNCIL IN PREVIOUS PRESENTATIONS, WE HAVE A VERY EFFECTIVE HIV PREVENTION TOOLKIT HOWEVER WE ARE EXPECTING THE EFFICACY OF THAT BY NEW INNOVATIONS AND SUCH AS LONG ACTING ART FOR PREP AND NUDE RAL TRIESING ANTIBODIES AS PREP. HERE ARE SOME EXAMPLES. IN DECEMBER OF 2021, THE FDA APPROVED THE FIRST INJECTABLE TREATMENT FOR HIV PRE EXPOSURE PROFILAXIS WHICH IS INJECTABLE CABOTEGRAVIR EXTENDED-RELEASE INJECTABLE SUSPENSION. WHICH CAN BE GIVEN EVERY TWO MONTHS AND PREVENT HIV AQUA SITUATION AS WELL AS OR IN MANY CASES BETTER THAN ORAL PREP WITH TRAVADA. ANOTHER STUDY PRESENTED AT THE MEETING SHOWED SUSTAINED EFFICACY OF THIS LONG-ACTING CABOTEGRAVIR AS PREP AMONG CISGENDER WOMEN. THIS SLIDE SHOWS A COUPLE OF THE STUDIES THAT ARE DONE THROUGHOUT THE COUNTRY ON THE PROMISE OF USING INTERMITTENT INFUSIONS 6 OF COMBINATIONS OF BROADLY NEUTRALIZING ANTIBODIES TO REPLACE THE NEED FOR DAILY ANTIRETROVIRAL THERAPY GIVEN ORALLY. WHAT IS PLOTTED IS THE SUPPRESSION OF PLAS MOW VIRINIA AFTER ANY VIRAL ORAL THERAPY WAS DISCONTINUED, AS AN ANALYTICAL TREATMENT INTERRUPTION. THE BROADLY NEUTRALIZING ANTIBODY IN BLUE DIVERGES GREATLY FROM THE PLACEBO IN RED AND AGAIN, THESE STUDIES WILL BE CONTINUED TO BE PURSUED FOR THE POSSIBILITY OF INTERMITTENTLY, A FEW TIMES A YEAR, HAVING PASSIVE TRANSFER OF ANTIBODY REPLACE THE NEED FOR DAILY A.R.T. MOVING ON TO MONKEYPOX UPDATE, IN AUGUST OF THIS YEAR, JUST LAST MONTH, CLIFF LINE AND I WROTE AN EDITORIAL IN THE NEW ENGLAND JOURNAL OF MEDICINE ENTITLED "MONKEYPOX PASS PAST AS PROLONG" AND WE SHOWED THE SIMILARITIES AS WELL AS DIFFERENCES BETWEEN THE VERY EARLY YEARS OF HIV AND WHAT WE'RE EXPERIENCING WITH THE EVOLUTION OF THE MONKEYPOX OUTBREAK. WHICH IS NOW, AS YOU KNOW, WORLDWIDE, WITH MORE THAN 55,000 CONFIRMED CASES IN 100 COUNTRIES AND NOW AS OF YESTERDAY, MORE THAN 21,000 CASES IN THE UNITED STATES WHICH AS YOU SEE, LEADS THE COUNTRIES THROUGHOUT WORLD IN NUMBER OF CASES. MONKEYPOX COUNTERMEASURES ARE AVAILABLE AS A RESULT OF WORK DONE DECADES AGO IN PREPARATION FOR A SMALLPOX BIO TERROR ATTACK. AND THEY INCLUDE TPOXX, VISITDE AND BRYNCIDOFOVIR AND WE HAVE JYNNEOA AS WELL AS THE ORIGINAL ACAM2000 WHICH IS A LIVE VACCINIA VIRUS VACCINE. THE FDA, LAST MONTH, AUTHORIZED THE EMERGENCY USE MAINLY IN EUA FOR JYNNEOA GIVEN AS AN INTRA DETERMINAL VACCINATION FOR PEOPLE 18 YEARS OF AGE AND OLDER AT A HIGH-RISK OF INFECTION. BUT THE EUA ALLOWED FOR THE INTRA DETERMINAL WHICH ACTUALLY CAN BE GIVEN AT 1/5 OF THE DOSE WITH COMPARABLE INDUCTION OF IMMUNE RESPONSE. THERE ARE CLINICAL TRIALS LAUNCHED OR PENDING ON MONKEYPOX. VERY BRIEFLY, ON SEPTEMBER THE EIGHTH, THERE WAS AN ALTERNATIVE STRATEGY FOR ADMINISTERING INTRA DETERMINAL DOSES OF JYNNEOS THE INTRA DETERMINAL I MENTIONED. ON THE NINTH OF SEPTEMBER, IT WAS A CLINICAL TRIAL OF TPOX IN THE UNITED STATES AS OUT PATIENT TREATMENT FOR PEOPLE WITH MONKEYPOX AND WHAT'S PENDING NOW, AND WILL START THIS MONTH IS A TPOX STUDY IN THE DEMOCRATIC REPUBLIC OF THE CONGO A STUDY LED BY CLIFF LANE. LET'S MOVE ON TO COVID UPDATES. THERE HAVE BEEN RECENT PAPERS NOW THAT STARTED OFF AS PRE PRINTS THAT ARE NOW BEEN PUBLISHED IN CELL AND SCIENCE HIGHLY PEER-REVIEWED SHOWING RATHER STRONG EVIDENCE FOR THE NATURAL OCCURRENCE AND EVOLUTION OF THE COVID-19 OUTBREAK FROM THE WUHAN MARKET IN CENTRAL CHINA AND THE DATA FROM HIGHLY QUALIFIED VIROLOGIST HAVE ANALYZED THE IN A STRONG WAY THIS WAS A NATURAL OCCURRENCE JUMPING FROM ANIMALS BROUGHT TO THE WUHAN MARKET. LET'S TAKE A LOOK AT THE EPI. CURRENTLY, THERE ARE OVER 600 MILLION REPORTED CASES AND SIX AND A HALF MILLION DEATHS GLOBALLY AND OTHERS I MENTIONED LAST TIME THE UNITED STATES IS DOING POORLY ON THIS AND ALMOST 100 MILLION REPORTED CASES AND NOW OVER 1 MILLION DEATHS OVER THE TWO AND A HALF YEARS OF THIS OUTBREAK. AS SHOWN HERE, WE ARE DOMINATED BY A BA5 ISOLATE SHOWN IN THE PURPLE ON THE RIGHT-HAND SIDE WHICH GRADUALLY. >> IF YOU LOOK AT THE DAILY CONFIRMED CASES IN THE UNITED STATES, AND COMPARE LAST WINTER IN JANUARY WITH TODAY, EVEN THOUGH THAT NUMBER IS UNACCEPTABLY HIGH AT A WEEKLY AVERAGE OF 75,000, IT IS A BIG DIFFERENCE FROM WHAT WE SAW IN JANUARY OF 800,000 A DAY. SAME WITH THE DEATHS. IN JANUARY WE WERE AVERAGING OVER 6,000 DEATHS PER DAY AND WE ARE NOW ABOUT 400. AGAIN, 400 IS AN UNACCEPTABLY HIGH LEVEL BUT JUST TO SHOW YOU THE DIFFERENCE BETWEEN THE STAGE IN JANUARY, AND WHERE WE ARE TODAY. AS I MENTIONED MANY TIMES, WE HAVE A THERAPEUTIC TOOLKIT FOR NON-HOSPITALIZED PATIENTS WITH PAXLOVID SHOWING CLEAR-CUT, HIGHLY EFFECTIVE AND KEEPING PEOPLE OUT OF THE HOSPITALS AS WELL AS OTHERS INCLUDING RECOMMENDDESIVIR AND MOLNUPIRAVI R & B TELOVIMAB AND ALSO A PROFILAXIS REDUCED THE RISK BY 80% OF DEVELOPING SYMPTOMATIC COVID COMPARED TO A PLACEBO. WE KNOW OF THE VACCINES WITH THE MODERNA AND THE BIOEN TECH PFIZER AND mRNA AS WELL AS THE J AND J AND NOW OTHERS INCLUDING THOSE AVAILABLE THROUGH EUA OR AS A BLA. RIGHT NOW WE'RE FOCUSING ON UPDATING THE VACCINES FOR THE ENTIRE COUNTRY AND NOW, THERE WAS A PRELIMINARY RESULT REPORTED IN A PRE PRINT THAT HIGHER OMICRON BA1 TITERS WERE OBSERVED COMPARED TO PROTOTYPE VACCINES AND THE TITERS AGAINST THE OMICRON BA45 WERE LOWER AGAINST BA1 ON ALL CANDIDATE VACCINES. BUT BASED ON THE TOTALITY OF EVIDENCE, AND THE EXPERIENCE OF THE BA1 OMICRON BIVALENT, THE CDC RECOMMENDED THE FIRST UPDATED COVID-19 BOOSTER WHICH IS A BIVALENT BA4-5 VACCINE AND FOR INDIVIDUALS OLDER THAN 12 OR OLDER FOR THE PFIZER mRNA AND INDIVIDUALS 18 OR OLDER WITH THE MODERNA mRNA. AND IN THE COMING WEEKS, THE CDC WILL BE EXPECTED TO RECOMMEND THAT UPDATED BOOST FOR THE OTHER PEDIATRIC GROUPS NAMELY THOSE YOUNGER THAN 12. LET ME QUICKLY MOVE ON TO NOW A REAL NEED, THE NEXT GENERATION CORONAVIRUS VACCINES. EITHER THE PAN-AND WE WROTE A PERSPECTIVE CALLING THE UNIVERSAL CORONAVIRUS VACCINES TRULY AN URGENT NEED GIVING THE EXPERIENCE WE'VE HAD WITH MULTIPLE VARIANTS. THERE'S A LOT OF REALLY GOOD WORK ALREADY GOING ON IN THE SPACE OF PAN CORONAVIRUS VACCINES PRE CLINICAL AND EARLY CLINICAL WORK. IN FACT, THERE'S A PAPER THAT JUST CAME OUT IN SCIENCE ABOUT A MONTH AGO, USING NANO PARTICLES WHICH PROTECT AGAINST CHALLENGED BY DIVERSE VIRUSES IN ANIMAL INFORMEDEL AND THE NIAID HAS MADE SIX RECENT AWARDS TOTALING ALMOST $60 MILLION FOR RESEARCH ON THESE BROADLY-PROTECTIVE CORONAVIRUS VACCINES WITH THREE-YEAR GRANTS IN THE INSTITUTION'S SHOWN HERE. ALSO, MUCOSAL VACCINES, WE KNOW, ARE EXTREMELY IMPORTANT FOR OUR FUTURE AGAINST PROTECTING INFECTION AND TRANSMISSION. THIS WAS NICELY REVIEWED IN AN ARTICLE LAST MONTH BY ERIC TOPOL ABOUT WHAT WE NEED TO DO WITH REGARD TO NASAL VACCINES TO COUNTER FUTURE COVID-19 AS WELL AS PRESENT AS ILLUSTRATED DEM ATTICLY THESE TYPE OF VACCINES WILL GIVE FASTER I AM AN TEE RECALL AFTER EXPOSURE AND ARE GEARED AT INFECTION AND TRANSMISSION BLOCKING. AND ALSO THE ADVANTAGE OF BEING NEEDLE FREE. ONE EXAMPLE OF THIS IS AN INACTIVATED WHOLE VIRUS CONSISTING OF SARS-CoV-2 FROM DIFFERENT STRAINS GIVEN BY AN INTER NASAL MIST IN A STUDY BY JEFF TAUBENBERGE SO THERE ARE GOOD PEOPLE EXTRAMURALLY WORKING ON THIS AND VERY QUICKLY LET ME CLOSE WITH A COUPLE OF OTHER UPDATES. VERY EXCITING WORK COMING FROM THE VRC WITH BOB CEDAR AND HIS COLLEAGUES IN A SINGLE INJECTION OF THE ANTIBODY L9LS WAS SAFE AND HIGHLY PROTECTED IN THE UNITED STATES ADULTS EXPOSED TO MALARIA PARASITES AND WE'RE GOING TO DO A LARGER TRIAL IN AFRICAN INFANTS AND CHILDREN. WE CONTINUE WITH THE WORK TOWARDS OUR PROTOTYPE PATHOGENS APPROACH FOR VACCINES AND MONO CRON ALAN TEE BODY WHICH SAY CRITICAL CAM PHONE ANT OF THE BROADER NIAID PLAN FOR PANDEMIC PREPAREDNESS. OUR STAFF AND I OUTLINED THIS IN A RECENT COMMENTARY IN THE JOURNAL OF INFECTIOUS DISEASES. THESE ARE THE TOP PRIORITIES OF THE VARIOUS FAMILIES AND WE'RE ALREADY WORKING ON SEVERAL OF THESE, FOR EXAMPLE, WE LAUNCHED THE CLINICAL TRIAL OF mRNA NIP OWE VIRUS VACCINES AS PHASE 1 AT THE NIH CLINICAL CENTER AND A PREVAIL STUDY DONE IN LI LIBERIS A VACCINE AGAIN A VERY IMPORTANT DISEASE IN THAT PART OF THE WORLD. AND ALSO THERE'S ENCOURAGING PROGRESS ON RSV VACCINES WORK THAT ORIGINATED FROM THE FUNDAMENTAL BASIC RESEARCH DONE BY BONNIE GRAHAM IN THE VRC YEARS AGO. AND LET ME CLOSE ON THIS LAST SLIDE, SO THAT WE DON'T FORGET THE IMPORTANCE OF THE WORK THAT WE'RE DOING TO DEVELOP A CURE FOR HEPATITIS B AS SHOWN IN OUR UPDATE THAT WAS PUBLISHED BY THE NIH HEPATITIS B STRATEGIC PLAN WORKING GROUP IN JULY 20622. OF 2022. SO I'LL STOP THERE AND BE HAPPY TO ANSWER ANY QUESTIONS. THANK YOU. >> OK, WELL, IF THERE ARE NO QUESTIONS, I CAN SEE, WE'LL HAVE TIME AT THE END AND I'LL BE ABLE TO GIVE THE OPPORTUNITY AFTER WE GET THE LAST PRESENTATION FROM Dr. HOLLAND. I DID NOT MENTION IN THE INTERESTING SOMETHING THAT I SHOULD HAVE AND THAT IS THAT THERE ARE SEVERAL MEMBERS WHOSE TERMS ARE EXPIRING ON OCTOBER 2022. AND I JUST WANT TO MENTION THEM AND THANK THEM FOR THEIR SERVICE TO US AND THAT IS Dr. ARGUILE, Mr. IBOW, Dr. GUPTA, Dr. RANDOLPH, AND Dr. RAY, SO THANK YOU SO MUCH FOR YOUR SERVICE TO US. AND BEFORE I INTRODUCE OUR NEXT SPEAKER, I JUST WANTED TO ACKNOWLEDGE AFTER 38 YEARS PRESIDING OVER THESE COUNCIL MEETINGS, THIS WILL BE THE LAST COUNCIL MEETING I WILL ADDRESS AS NIAID DIRECTOR AND I JUST WANT TO MENTION VERY SINCERELY THIS HAS BEEN AN ENORMOUS PLEASURE AND PRIVILEGE OF MY JOB TO HAVE WORKED WITH THE MANY EXTRAORDINARY AND TALENTED INDIVIDUALS WHO SERVED ON OUR COUNCIL, OVER THE YEARS. WE HAVE A TRULY OUTSTANDING INSTITUTE STRENGTHENED BY OUR INTERACTIONS WITH OUR COUNCIL. I'M CONFIDENT THE INSTITUTE WILL BE IN KALE ABLE HANDS AFTER I LEAVE AND I WANT TO THANK THOSE OF YOU HERE TODAY FOR YOUR SERVICE TO OUR INSTITUTE AS WELL AS PAST COUNCIL MEMBERS THAT HAVE SERVED US SO WELL OVER THE YEARS. COUNCIL MEMBERS ARE CRITICAL ADVISERS WHO BRING TO THE TABLE OUTSIDE PERSPECTIVES AND IDEAS THAT HELP AND SHAPE AND ADVANCE OUR MISSION SO THANK YOU SO MUCH FOR THAT. NOW I WOULD LIKE TO INTRODUCE Dr. STEVEN HOLLAND THE DIRECTOR OF YOU ARE INTRAMURAL RESEARCH PROGRAM WHO WILL PRESENT DURING THE NEXT PART OF OUR PROGRAM. STEVE, OVER TO YOU. >> THANK YOU SO MUCH, TONY AND THANK YOU FOR YOUR EXTRAORDINARY YEARS OF SERVICE. IT HAS BEEN A REAL HONOR AND PLEASURE TO SERVE UNDER WOW. AND I WILL NOW JUST GIVE A VERY BRIEF UPDATE ON THE INTRAMURAL PROGRAM AND I'M GOING TO SHARE MY SLIDES HERE BRIEFLY. IS THAT IN THE RIGHT MODE? >> THAT'S CORRECT. >> VERY GOOD. OK, SO I WILL GET RIGHT TO THE POINT. I'M GOING TO TALK TO YOU ABOUT THE INTRAMURAL PROGRAMS AND THE PRESENT, THE RECENT PAST THIS LAST YEAR AND SOME VERY FEW SELECT RESEARCH HIGHLIGHTS AND THEN I NEED YOUR HELP AT THE VERY END. SO, REMEMBER, INTRAMURAL RESEARCH, INSIDE THE WALLS IS WHAT WE'RE TALKING ABOUT AND THE CURRENCY STEMS FROM THE BOARD OF SCIENTIFIC COUNCILORS REVIEW. EVERY LAB, EVERY PRINCIPLE INVESTIGATOR, AT LAST EVERY FOUR YEARS GETS REVIEWED AND THIS IS A LARGE HIGHLY PROFESSIONAL, VERY ACCOMPLISHED GROUP, MANY OF YOU HAVE SERVED ON THESE COMMITTEES. CURRENTLY, WE ONLY DO IT TWICE A YEAR IN DECEMBER AND JUNE AND WE'RE DOING OUR BEST TO KEEP IT TO THAT LEVEL. IT'S HARD, INTENSE AND IT'S A LOT OF READING AND A LOT OF QUESTIONING AND A LOT OF LEARNING FOR EVERYBODY INVOLVED. WE STRIVE TO MAKE SURE THAT ALL OF OUR WORK IS AGAIN EYE INLY OUT STANDING AND WE NEED YOUR INPUT TO MAKE SURE THAT WE STAY TO THAT MARK. AND REALLY FROM THAT EVALUATION, ALL THINGS FLOW. THIS IS JUST A BRIEF LOOK AT THE NUMBER OF PRINCIPLE INVESTIGATORS IN THE INTRAMURAL PROGRAM. WE HAVE FLUCTUATED SOME OVER THE YEARS AND WE'VE NOW GOT A GOOD NUMBER ON TENURE TRACK AND WE'RE LOOKING FORWARD TO MAKING THESE THINGS COME TO LIFE. SO, REMINDING YOU THE PROGRAM HAS SEVERAL COMPONENTS. THE INTRAMURAL PART HERE IN BETHESDA IS SHOWN AT THE TOP OF THE SLIDE. OUR CAMPUS AT ROCKY MOUNTAIN IN HAMILTON, MONTANA, WHERE WE DO SO MUCH OF THE REALLY EXTRAORDINARY VSL3 AND 4 WORK AND THERE ARE MANY SITES AROUND THE GLOBE THAT ARE PART OF THE INTRAMURAL PROGRAM AS WELL AS MANY CRITICAL EXTRAMURAL COMPONENTS. SO OUR PRIORITIES IN THE INTRAMURAL PROGRAM ARE TO MAKE SURE WE'RE DOING TRANSFORMATIVE MEDICINE AND BIO MEDICAL RESEARCH AND THE BENCH-TO-BEDSIDE APPROACH THAT TAKES FULL ADVANTAGE OF THE CLINICAL CENTER WHICH IS REALLY QUITE A PRIVILEGE TO HAVE AND AS WELL AS OUR DOMESTIC AND INTERNATIONAL SITES. WE WANT TO BE RESPONDING TO PUBLIC-HEALTH THREATS INCLUDING DRUG RESISTANT MICROBES, EMERGING VIRUSES AND THE DESPERATELY NEEDED VACCINES THAT HAVE BEEN SO IMPORTANT TO US. WE WANT TO PARTNER TO ADVANCE THESE APPROACHES AND TO DO IT ACROSS BOTH INFECTIOUS AND IMMUNE LOGIC DISEASES. SO WHAT HAVE WE DONE IN THE LAST YEAR? WE'VE GOT 802 PUBLICATIONS SO FAR AND THE YEAR IS NOT OVER FOR US. THERE HAVE BEEN MANY THINGS HIGHLIGHTED BY THE NIAID BLOG AND WE HAVE ABOUT 200 ACTIVE CLINICAL STUDIES GOING ON THROUGH THE INSTITUTE. AS TONY MENTIONED, COVID FUNDING HAS BEEN AN IMPORTANT PART OF WHAT WE'VE BEEN WORKING WITH FOR THE LAST COUPLE OF YEARS. AND WITH THAT FUNDING, WE HAD MORE THAN 60% OF OUR PRINCIPLE INVESTIGATORS TAKE ON AND DEVELOP COVID PROJECTS LEADING TO NOW 451 PUBLICATIONS AND 80PIs AND BRANCHES WERE FUNDED INITIALLY. CURRENTLY THAT NUMBER HAS FALLEN A LITTLE BIT AS PEOPLE HAVE COMPLETED PROJECTS THAT HAVE NOW MOVED ON BACK TO THEIR PRIMARY INTERESTS. ONE OF THE APPROACHES WE'VE TAKEN TO THIS IS TO CREATE A SARS-CoV-2 VIROLOGY CORE WHERE WE CAN DO THE VSL3 WORK REQUIRED WITH PEOPLE WHO ARE EXPERT IN IT SO LABS WITH GOOD IDEAS COULD COME IN AND MAKE THOSE IDEAS WHOLE BUT DO IT WITH EXPERTS THAT WILL HELP US TO DO IT SAFELY. TED PIERSON THE CHIEF OF THE LABRADOR OF VIRAL DISEASES PUT TOGETHER THIS OUTSTANDING GROUP LED BY REID JOHNSON AND NICOLE LACKMIRE AND IT'S BEEN SUPPORTING RESEARCH FROM AROUND THE CAMPUS FROM LABORATORIES THAT DID NOT HAVE BSL3 CAPACITY. IT'S BEEN VERY SUCCESSFUL AND AS WE TRY TO THINK THROUGH WHAT IS THE APPROACH WE WANT TO BE DEVELOPING FOR PANDEMIC PREPAREDNESS IN THE INTRAMURAL PROGRAM, THIS IS ONE OF THE THINGS THAT I THINK WILL BE A PARADIGM FOR US. OF COURSE, IN THE LAST FEW MONTHS, MONKEYPOX HAS BEEN AN IMPORTANT COMPONENT OF OUR THINKING AND VINCENT MUNSTER HAS RISEN TO THE TASK HERE AND STUDYING VIRAL EVOLUTION, DIAGNOSTICS, THERAPEUTICS, AND ENVIRONMENTAL STABILITY AS WELL AS TRANSMISSION IN BOTH STUDIES IN THE CONGO AS WELL AS IN MONTANA. MOVING TO SOME OF THE CHANGES IN THE INTRAMURAL PROGRAM, WE'VE HAD TWO NEW LABORATORY CHIEFS SELECTED IN THE LAST YEAR AND CAROLINA MURRAY WHO IS NOW THE CHIEF OF THE LABORATORY OF MALARIA VECTOR RESEARCH AND A WORLD-RENOWNED INVESTIGATOR AND SONIA BEST THE CHIEF OF THE LAB TORE' OF PERSISTENT VIRAL DISEASES NOW THE LABORATORY OF NEWER LOGIC INFECTION AND IMMUNITY. SHE'S A VIROLOGIST AND IMMUNOLOGIST WHO WILL MARY THOSE THINGS TOGETHER AROUND -- MARRY THESE THINGS AROUND THE SYNDROMES. WE'VE BEEN INCREASING OUR NUMBER OF DEPUTY LAB CHIEFS IN RECOGNITION THAT YOU KNOW, DEATH TAXES AND ADMINISTRATIVE BURDENS ARE ALL INEVITABLE PARTS OF LIFE AND SO WE'VE BEEN GATHERING HELP TO DO THIS AND IN THE LABORATORY OF PARASITIC DISEASES, AMY KLEEON AND ELODIE GHEDIN HAVE JOINED THAT PROGRAM. WE'VE BEEN ADDING TO OUR RANKS AS WELL, THIS YEAR, WE HAVE A TENURED INVESTIGATOR AND YOU SAW ULA'S WORK ASK I'LL SHOW YOU MORE OF THAT IN A MOMENT. WE'VE GOT THREE-NEW TENURE TRACK INVESTIGATORS COMING INTO THE TOP TWO. ERIC VAN DANG AND HAU JIN ARE JOINING AND ERIC WILL WORK ON FUNGI AS PART OF THE MICRO BUY HOME AND HAO JIN WILL WORK ON NEURO LOGIC FUNCTION AND IMMUNITY AND HOW THOSE TWO THINGS INTERFACE AND TIJANA IVANOVICH IS JOINING LOOKING AT THE ULTRASTRUCTURE OF HOW VIRUSES GET INTO AND LIVE WITHIN CELLS. JUST REMIND YOU, OUR TENURE TRACK PROGRAM, WE HAVE SEVERAL DIFFERENT ROADS THAT LEAD TO THE SAME DESTINATION. AND THERE BE CAN A TENURE TRACK SEARCH SELECTED BY A LAB FROM AN ADD. THERE IS SOMETHING CALLED THE EARLY STADTMAN PROCESS THAT ARE OPEN APPLICATIONS BASIC SIGNS AND THAT COME IN FROM ALL AROUND THE COUND TREE AND AROUND THE WORLD AND THE LASKER CLINICAL PROGRAM WHICH IS AGAIN AN OPEN PROCESS FOR CLINICAL APPLICANTS AND THAT STAY HERE FOR FIVE YEARS AND HAVE A CHANCE TO STAY OR GO TO THE OUTSIDE WITH SUPPORT AND THEN FOR ALL OF THESE GROUPS, THERE'S WHAT IS CALLED THE DISTINGUISHED SCHOLAR PROGRAM WHICH IS FOR PEOPLE WITH A DEMONSTRATED AND SIGNIFICANT COMMITMENT TO DIVERSITY AND WE ARE VERY PROUD TO HAVE EIGHT DISTINGUISHED SCHOLARS IN THE TIRIN TRA MURAL PROGRAM. JOHN ZHANG LEFT TO FORM A PROGRAM AT YALE AROUND BIG OMICS-TYPE RESEARCH IN IMMUNOLOGY AND YOU KNOW ABOUT SOME OF OUR UPCOMING RETIREMENTS. TONY HAS MENTIONED HIS AND THE HAR LA CALDWELL WILL STEP DOWN,M LIDO WHO HAS BEEN A LEADER IN BIOLOGY WILL BE RETIRING NEXT YEAR. ELLEN CHER WHO LED CURRENTLY HELPS ONE OUR OX CAM PROGRAM WILL BE STEPPING DOWN THIS YEAR. ROCKY MOUNTAIN LABS, WE'VE HAD A REAL TURNOVER WHICH IS WHY SOME OF THE TENURE TRACKS LAST YEAR ARE OUT THERE AND JOE HINABUSH, BOB HEINESON, FRANK GHERADINI, DANA SCOTT WHO LED THE ROCKY MOUNTAIN VETERINARY BRANCH AND PATTY ROSA WHO ALSO LED THE LABORATORY OF BACK TERROLOGY FOR MANY YEARS AND HAS BEEN A LIME INVESTIGATORS. ON THIS CAMPUS, WE HAVE TWO LAB CLOSINGS THAT IS DIFFERENT THAN RETIREMENT. THESE PEOPLE WILL BE STAYING ON. JOHN GALLON WILL BE CLOSING HIS LABORATORY AFTER SEVERAL DECADES AND I THINK FIVE DECADES OF SUCCESSFUL CRITICAL WORK AND HE WILL STILL ON FOR CLINICAL RESEARCH AND THE CHIEF SCIENTIFIC OFFICER OF THE CLINICAL CENTER AND BOB MUNFORD WHO HAS BEEN THE SENIOR CLINICIAN IN THE LABORATORY OF CLINICAL IMMUNOLOGY AND MICROBIOLOGY WAS DEPUTY LAB CHIEF FOR MANY YEARS AND HAS BEEN OVERSEEING OUR SCIENTIFIC REVIEWS WILL BE CLOSING DOWN HIS SECTION BUT CONTINUING ON STAFF FOR A WHILE. THIS LEAVEs WITH SEVERAL OPENINGS THAT WE'RE LOOKING TO FILL. WE REALLY WOULD APPRECIATE YOUR HELP IN THIS. THE ROCKY MOUNTAIN VET TRA NAIR YAN BRANCH IS OPEN AND THE LABORATORY OF ALLERGIC DISEASES HAS TWO TENURE TRACK POSITIONS IT'S LOOKING TO FILL AND THEN WE ARE, AS YOU KNOW, LOOKING FOR LABORATORY CHIEFS. THE LABORATORY OF IMMUNO REGULATIONS THAT IS TONY'S LABORATORY, WILL BE LOOKING FOR A NEW CHIEF IN THE NEXT YEAR AND THE LABORATORY OF IMMUNOGENETICS LED BY SUE PIERCE WHO WILL STEP DOWN SOON, WILL LOOK FOR A CANDIDATE INTERNALLY BECAUSE OF SPACE CONSIDERATIONS. JUST A COUPLE OF VERY QUICK RESEARCH HIGHLIGHTS. WE ARE STILL DOING A LOT OF COVID WORK AS I KNOW MANY OF YOU ARE AS WELL. WE HAVE PUT TOGETHER A MULTI-NATIONAL TRIAL TRYING TO LOOK AT A MULTI OMIC APPROACH O CHILDREN LOOKING AT MISS C AND AT PEDIATRIC ACUTE COVID AS WELL AS HEALTHY CONTROLS AND I THINK YOU CAN SEE HERE THE LARGE NUMBER OF RED SPOTS ON THE LEFT IN THE COHORT AND IN THE ACUTE COHORT IN BLUE AND REALLY IDENTIFYING THEM AS DISTINCT DISEASES AND HE HAS BEEN IDENTIFYING TARGETS. KATIE BOSSOIO HAS BEEN IMMUNO METABOLISM TO COVID. LAST YEAR SHE WORKED ON THIS IN A HUMAN COHORT FROM YALE AND THIS YEAR SHE'S WORKING WHAT DOES THE RECEPTORS FOR ADVANCES GLY INDICATION OR RAGE HAS TO DO WITH IT AND IF YOU BLOCK RAGE YOU CAN INCREASE SURVIVAL IN A MOUSE MODEL GIVING KATIE NEW TARGETS TO GO AFTER IN TERMS OF THERAPEUTICS. FOLLOWING ALONG THE SAME SORT OF HOW TO USE THE MOUSE MODEL, SONIA BEST HAS PUT TOGETHER A REALLY IMPORTANT STUDY WITH NADDIA ROSENTHAL FROM JACK'S LABS USING THE COLLABORATIVE CROSS TO LOOK AT MOUSE GENETICS AND HOW WE CAN USE THOSE. I WANT TO POINT OUT HERE, ON THE LEFT SIDE, YOU SEE IN THE LEFT-TOP PANEL, MICE THAT DIE. THESE ARE ACE 2 TRANSGENIC MICE IN THE COLLABORATIVE CROSS. THEY DIE WITH COVID. OK, THEN THERE'S SOME MICE THAT ARE RESISTANT THAT TELL US MOUSE GENES WE CAN GO AND IDENTIFY. IF YOU GO INFORM THE RIGHT SIDE, IT'S LESS EXPECT AND MORE INTERESTING. WHAT YOU SEE ON THE TOP, IS THAT HERE IS A STRAIN OF MICE IN WHICH THE MALES ARE DRAMATICALLY MORE SUSCEPTIBLE TO COVID INFECTION AND NOT TOO DISSIMILAR FROM WHAT IS SEEN IN HUMANS AND ON THE BOTTOM, YOU SEE STRAINS ONLY THE FEMALE CARRY THE HIGH SUSCEPTIBLE. IT'S FASCINATING TO DISSECT THE GENETICS IN THE MOUSE THAT WE CAN GO BACK TO THE HUMAN TO INTERROGATE. FINALLY, ULA BUCKHOLD WORKS ON TRYING TO IDENTIFY VACCINES THAT ARE GOOD AGAINST COVID. SHE'S VERY INTERESTING IN RSV AND OTHER INFECTIONS AS WELL. IN THIS PARTICULAR PAPER, STILL IN THE PRE PRINT, WHAT YOU SEE IS IS SHE'S USING THE BOVINE HUMAN PARA 3 TO MAKE A SPIKE EXPRESSING VIRUS THAT IS HIGHLY STABILIZED AND WHAT YOU CAN SEE HERE, IF YOU LOOK AT THE BOTTOM PANEL, IN LUNG TISSUE, YOU CAN REALLY PREVENT THE PROLIFERATION OF SARS-CoV-2 AFTER A VIRUS CHALLENGE IN MACAQUES. SO HOPE THAT THIS MUCOSAL VACCINE COULD BE USEFUL. NOW, YOU KNOW, HAS THERE NOT MORE THAN COVID? OF COURSE. AND THERE WILL CONTINUE TO BE MORE THAN COVID. WE HAVE OTHER PANDEMIC THREATS TO WORRY ABOUT, HINES FELDMAN WORKS ON FEVER. CAN YOU SEE THIS VIRUS THAT THIS VACCINES THAT IS PROFOUNDLY PROSPECTIVE AGAINST CCHF AND HEINZ HAS BEEN TAKING THIS FORWARD. WE STILL HAVE MANY DIFFERENT CONTROLS TO UNDERSTAND HOW IMMUNE FUNCTION AND DYSFUNCTION WORK. HERE IN THIS REALLY ELEGANT TRANS INSTITUTE COLLABORATION BETWEEN YASMIN AND JULIE AND LED LOOKING HOW IS IT THAT ANTIBIOTICS, PRE DISPOSE TO FUNCTIONAL INFECTION. WE DON'T TYPICALLY THINK ABOUT BACTERIA BEING THE CAUSE OF FUNGAL DISEASE BUT AS YOU SEE IN THIS SCHEMATIC ON THE LEFT, IT'S THE REDUCTION IN CERTAIN BACTERIA AND THE GROUND POSITIVE CATEGORY THAT DIMINISH THE TH-17 ACTIVATION THAT ALLOW FOR FUNGAL PROLIFERATION AND CANADA DEEMIA AND PUTTING THESE MECHANISMS INTO CONTEXT IS WHAT WILL GIVE US REAL INSIGHTS TO GO FORWARD AND IDENTIFY SOME OF THE WAYS THAT WE TREAT OUR INTENSIVE CARE PATIENTS AND SO ON. AND THEN STAYING WITH THE BOWEL AS CRITICAL SITE OF ACTIVITY, MIKE LEARNARD OWE AND CO-WORKERS TOOK A HUMAN MUTATION THAT WAS RECOGNIZED IN A GENE INVOLVED IN MUCUS PRODUCTION TO RECOGNIZE THE CRITICAL ROLE FOR MUCUS SIGHALLATION IN MANAGING INDESTINATION HOST COMME COMMENE HOMEOSTASIS. IT HAS GIVEN US NEW IN SIGHT INTO HOW THE BOWEL FUNCTIONS AND HOW THE BOWEL PROTECTS ITSELF FROM INVASION. LASTLY, AS I CAME INTO THIS POSITION SEVERAL YEARS AGO, WE TALKED ABOUT A NEW APPROACH TO DOING HUMAN EX OWN SEQUENCE AND NOW HUMAN GENOME SEQUENCING. I WANT TO SHARE THE RESULTS OF THE FIRST 1,000 INDIVIDUALS SO OUR APPROACH HERE IS THAT EVERY PATIENT WHO COMES INTO THE NIAID, WHETHER THEY'RE NORMAL VOLUNTEER OR HIV INFECTED, IMMUNODEFICIENCY IS OFFERED THE CHANCE TO HAVE A WHOLE GENOME SEQUENCE DONE AND THE FIRST 1,000 PATIENTS THAT WERE SEQUENCES ARE SHOWN HERE. IT'S TOO SMALL TO READ WHAT THE GENES ARE AND IT'S VERY SKEWED TOWARDS THE DISEASES THAT WE STUDY A LOT OF. IF WE BREAK IT DOWN WHAT'S DID WE FIND IN LOOKING AT THE FIRST 1,000. WE FOUND MOLECULAR DIAGNOSIS IN 33%. 17 OF THOSE PEOPLE HAD COPY NUMBER VARIANTS, KIND OF STUFF YOU DON'T PICK UP ON WHOLE EX OWN SEQUENCING AND 32 OF THOSE PEOPLE HAD SECONDARY FINDINGS THAT'S THE KIND OF GENETIC PROBLEMS THAT THE AMERICAN COLLEGE OF MEDICAL GENETICS SAYS YOU NEED TO TELL PEOPLE ABOUT THIS WHETHER IT'S BRACK A 2 OR SOMETHING LIKE THAT. AND THEN 31 PEOPLE HAD MULTIPLE MOLECULAR DIAGNOSIS. IF YOU HAVE ONE MENDILIAN MUTATION, WHAT'S THE LIKELIHOOD YOU HAVE A SECOND ONE AND THE RATE FROM THAT RANGES FROM FIVE TO 10%. THINK ABOUT IT, JUST BECAUSE YOU GOT ONE PROBLEM, DOESN'T MEAN YOU DON'T HAVE TWO AND THEN IN AR PARADIGM FOR WHERE WE'RE GOING, REANAL SIGHS IDENTIFIED 22 MORE DIAGNOSIS AND IN NINE OF THOSE 22, THEY WERE NOVEL DISEASE GENE ASSOCIATIONS. SO, THIS IS REALLY WHERE THE FIELD IS HEADED AND I THINK WHERE WE'RE TAKING A GOOD ROLE HERE. SO, COMING TO THE END HERE, WHAT ARE OUR FUTURE DIRECTION THIS IS WE'RE OBVIOUSLY STILL WORKING HARD TO RECRUIT TALENTED AND DIVERSE INVESTIGATORS AND HE WANT TO FOSTER THESE BENCH-TO-BET SIDE APPROACH AND MAKE SURE THE CLINICAL CENTER RESOURCES ARE AVAILABLE TO ALL LABS, WHETHER BASIC OR CLINICAL. THAT IS WHERE WE CAN BRING THIS ALL TOGETHER. WE WANT TO PROMOTE THIS STUDY OF PATHO PHYSIOLOGY, INNOVATIVE STRATEGIES, VACCINES TARGETS, DIAGNOSTICS AND THERAPEUTICS AND ENCOURAGE OUR EXTRAMURAL AND INTERNATIONAL COLLABORATIONS. SO, NOW I'VE FINISHED THAT PART AND GIVE ONE LAST THING I NEED TO ASK FOR YOUR HELP WITH AND THIS IS CALLED A CONCEPT CLEARANCE. SOMETIMES WE DO THIS IN THE SMALLER GROUPS AND I'M GOING TO TAKE ADVANTAGE OF HAVING YOU ASSEMBLED HERE. WE NEED YOUR ADVICE ON WHETHER WE CAN GO FORWARD WITH IMPLEMENTING THIS APPROACH. SO THE CONCEPT CLEARANCE IS FOR SCIENTIFIC AND TECHNICAL STAFF AND SERVICES TO SUPPORT COLLABORATION WITH THE UGANDA VIRUS RESEARCH INSTITUTE ON EMERGING INFECTIOUS DISEASES. SO, PRIOR TO ANY MAJOR NIH CONTRACT SOLICITATIONS, THE SCIENTIFIC CONCEPT MUST BE APPROVED BY A FEDERAL ADVISORY COMMITTEE SUCH AS A BSC AND THE INSTITUTE SENIOR LEADERSHIP. AND THE CONSIDERATIONS INCLUDE HERE THE PURPOSE, THE SCOPE, AND THE OBJECTIVES OF THE CONTRACT. SO, IN BROAD OUTLINES, WE WANT TO OBTAIN PERSONNEL AND SCIENTIFIC SERVICE TO SUPPORT LABORATORY AND FIELD-BASED RESEARCH AT THE UGANDA VIRUS RESEARCH INSTITUTE IN UGANDA AND FIELD COLLECTION SITES THROUGHOUT UGANDA. THIS IS IN ORDER TO SUPPORT ON GOING RESEARCH COLLABORATIONS BETWEEN THE LABORATORY OF VIROLOGY HINES FELDMAN AND VINCENT MUNSTER IN PARTICULAR AND THE UVRI ON EMERGING INFECTIOUS DISEASES. OTHER LABORATORIES MAY PARTICIPATE IN THE FUTURE. SOME OF YOU MAY KNOW THE LABORATORY OF IMMUNE REGULATION HAS A PROGRAM THERE WITH TOM QUINN ALREADY IN UGANDA. AND THE OBJECTIVE HERE IS TO SUPPORT THE UGANDA RESEARCHERS AND RESEARCH SUPPORT STAFF AND SERVICES WITH RESEARCH SUPPORT STAFF AND SERVICES REQUIRED TO FACILITATE APPROPRIATELY REVIEWED AND APPROVED LABORATORY AND FIELD BASED STUDIES ON EMERGING INFECTIOUS DISEASES IN UGANDA SO WE'RE ASKING FOR YOUR A APPROVAL AND THIS WILL BE DETERMINED AT THE DMID DISCUSSION LATER ON TODAY AND WE'RE ASKING FOR YOUR APPROVAL OF THE CONCEPT THAT WE WOULD BE ABLE TO GO FORWARD WITH THIS. I'LL STOP THERE AND SAY THANK YOU, VERY MUCH AND I WILL BE HAPPY TO TAKE ANY QUESTIONS. >> ARE THERE ANY QUESTIONS OF STEVE ON HIS PRESENTATION? ALL RIGHT. SEEING NONE, WHAT WE'LL DO RIGHT NOW, THANK YOU SO MUCH, STEVE. I APPRECIATE IT. >> THANK YOU, TONY. >> Dr. Anthony S. Fauci: SO, WE WANT TO TAKE A COUPLE OF MINUTE BREAK. MATTHEW, SINCE WE'RE DOING THIS VIRTUALLY, HOW LONG DO WE -- WE JUST NEED PEOPLE WHO ARE NON HARE-GOVERNMENT, WE WOULD ASK THEM TO LEAVE THE ROOM SO WE CAN MOVE INTO THE CLOSED SESSION