MY NAME IS MARY GLENSHAW, DESIGNATED FEDERAL OFFICIAL OR EXECUTIVE SECRETARY OFFICE OF AIDS RESEARCH ADVISORY COUNCIL, OARAC. WELCOME, THANK YOU FOR YOUR PARTICIPATION TODAY. AS A REMINDER OUR COUNCIL IS GOVERNED BY PROVISIONS OF FEDERAL ADVISORY COMMITTEE ACT OR FACA AS AMENDED WHICH SETS FORTH STANDARDS FOR THE FORMATION AND USE OF ADVISORY COMMITTEES. TODAY'S MEETING WE WILL FOLLOW SOME GENERAL GUIDELINES, FIRST PLEASE STAY MUTED AT ALL TIMES UNLESS SPEAKING. PLEASE KEEP YOUR CAMERA ON FOR MOST OF THE MEETING. FEEL FREE TO HIDE YOUR CAMERA P IF YOU NEED TO LEAVE MOMENTARILY AND RETURN. WHEN YOU WOULD LIKE TO PARTICIPATE IN DISCUSSION PHYSICALLY RAISE YOUR HAND OR USE THE ZOOM RAISE HAND FEATURE. THE CHAIR DR. TOLBERT AND I WILL NOTE WHO WANTS TO SPEAK AND CALL ON YOU IN TURN SO WE CAN AVOID SPEAKING OVER EACH OTHER. PLEASE DO BE AWARE YOU WILL NEED TO LOWER THE FEATURE ONCE YOU MADE YOUR REMARKS. FOR THIS MEETING THE ZOOM CHAT FEATURE IS ENABLED ONLY FOR LOGISTICS MESSAGES TO THE HOSTS. ANY CONCERNS SEND ME A TEXT MESSAGE AND YOU CAN ALSO CONTACT MS. MELISSA OUR INFORMATION IN YOUR INBOX. FOR EVERYONE ON THE VIDEOCAST, IF YOU WOULD LIKE TO SEE THIS PRESENTATION USING CLOSE CAPTION FEATURE, PLEASE CLICK THE CC ICON IN THE BOTTOM RIGHT CORNER OF THE VIDEO. NOW I WOULD LIKE TO REMIND OUR OARAC MEMBERS OF POLICIES REGARDING CONFLICTS OF INTEREST. COUNCIL MEMBERS MAY NOT PARTICIPATE IN THE REVIEW OR DISCUSSION OF SPECIFIC PROGRAM OR PROJECT FOR WHICH THEY HAVE A REAL OR APPARENT CONFLICT OF INTEREST. IF A PROGRAM OR PROJECT IS DISCUSSED THAT PREVENTS AS CONFLICT FOR YOU YOU MUST EXCUSE YOURSELF FROM THE MEETING. TO DO THIS PLEASE SIGNAL ME AND WE WILL MOVE YOU TO A SEPARATE MEETING SPACE IN THE ZOOM. FOR THE PORTION OF THE DISCUSSION THAT POSES THE CONFLICT. AT THE CONCLUSION OF TODAY'S MEETING, YOU WILL HAVE FORM IN YOUR IN BOX, PLEASE KINDLY ELECTRONICALLY SIGN IT TO CONFIRM THAT NO CONFLICTS WERE PRESENTED FOR YOU TODAY. ARE THERE ANY QUESTIONS REGARDING POTENTIAL CONFLICT OF INTEREST FOR TODAY'S MEETING? HEARING NONE, PLEASE DO REMEMBER THAT TODAY'S MEETING IS OPEN TO THE GENERAL PUBLIC. AND IS CURRENTLY BEING RECORDED AND VIDEOCAST LIVE. I WILL NOW TURN THE MEETING OVER TO OUR CHAIR, DR. BLANTON TOLBERT WHO WILL BRING THE MEETING TO ORDER. THANK YOU >>THANK YOU, MARY. SO GOOD AFTERNOON, EVERYONE. THE 62ND MEETING OF OFFICE OF AIDS RESEARCH ADVISORY COUNCIL IS IN SESSION. WELCOME COUNCIL MEMBERS, INVITED SPEAKERS, NIH COLLEAGUES AND GUESTS WHO ARE LISTENING IN. COLLEAGUES I WANT TO START BY INTRODUCING OUR OARAC AD HOC ADVISOR, EXCUSE ME, AD HOC MEMBER, WHO IS JOINING US TODAY AND THAT IS DR. LOUISE (INDISCERNIBLE) OF THE WYSTAR INSTITUTE. AS REMINDER AD HOC MEMBERS WILL BE FORMALLY INTRODUCED WHEN THEY JOIN AS FULL VOTING MEMBERS. WELCOME, WE LOOK FORWARD TO YOUR INPUT. WE WILL MOVE WITH THE ROLL CALL. COLLEAGUES WHEN I CALL YOUR NAME STATE YOUR POSITION AND INSTITUTIONAL AFFILIATION. DR. TABIA AKINTO AKINTOBI. >>GOOD MORNING. TABIA AKINTOBI, PROFESSOR AND CHAIR DEPARTMENT OF COMMUNITY HEALTH AND PREVENTIVE MEDICINE, AND PRINCIPLE INVESTIGATOR OF THE INSTITUTIONS PREVENTION RESEARCH CENTER. >>THANK YOU. DR. MARGARET BRANDEAU. >>PROFESSOR MANAGEMENT SCIENCE AND ENGINEERING AND PROFESSOR HEALTH POLICY STANFORD UNIVERSITY. >>DR. KATHLEEN COLLINS. >>GOOD MORNING. I'M KATHLEEN COLLINS, PROFESSOR OF INTERNAL MEDICINE IN THE DIVISION OF INFECTIOUS DISEASE AND PROFESSOR OF MICROBIOLOGY IMMUNOLOGY AT UNIVERSITY OF MICHIGAN. ALSO I'M DIRECTOR OF MICHIGAN MSTP AND ASSOCIATE DEAN OF PHYSICIAN SCIENTISTS EDUCATION AND TRAINING. I RUN A LABORATORY THAT STUDIES MOLECULAR MECHANISMS OF HIV DISEASE PATHOGENESIS. >>THANK YOU, DR. COLLINS. DR. HEIDI CRANE. YOU ARE MUTED DR. CRANE. >>MY APOLOGIES, HEIDI CRANE, UNIVERSITY OF WASHINGTON PROFESSOR INFECTIOUS DISEASES. >>THANK Y THANK YOU. DR. SHRUT. >>GOOD MORNING, EARN, PROFESSOR AND VICE CHAIR DEPARTMENT OF EPIDEMIOLOGY JOHNS HOPKINS AND ALSO CO-DIRECTOR OF THE JOHNS HOPKINS CFAR. >>THANK YOU. DR. VERONICA MILLER. >>VERONICA MILLER, UNIVERSITY OF CALIFORNIA BERKELEY SCHOOL OF PUBLIC HEALTH. WHERE I'M ON FACULTY AND ALSO THE DIRECTOR OF THE FORUM FOR COLLABORATIVE RESEARCH. >>THANK YOU, DR. MILLER. DR. -- EXCUSE ME RICARDO RIVERA. >>GOOD MORNING, EVERYONE. RICARDO RIVERO, PROFESSOR AT UNIVERSITY OF ILLINOIS COLLEGE OF MEDICINE, DEPARTMENT OF FAMILY MEDICINE AND EXECUTIVE DIRECTOR OF THE MIDWEST AIDS (INDISCERNIBLE) CENTER. >>THANK YOU, DR. RIVERO. DR. JOHN SLEASMAN. >>JOHN SLEASMAN, PROFESSOR CHIEF OF DIVISION OF ALLERGY IMMUNOLOGY AT DUKE UNIVERSITY AND MEMBER OF THE SCIENTIFIC LEADERSHIP GROUP FOR IMPACT. >>THANK YOU. LAST, OF OUR VOTING MEMBERS DR. IVY TURN BUTURNBALL.YOU ARE MUTED DR. TU >>I'M SORRY. GOOD MORNING, EVERYONE. IVY TURNBALL, DEPUTY EXECUTIVE DIRECTOR AIDS ALLIANCE FOR WOMEN INFANTS CHILDREN YOUTHND FAMILIES AND CHAIR OF THE NATIONAL BLACK WOMEN'S HIV AIDS NETWORK. >>THANK YOU, DR. TURNBALL. COLLEAGUES I WILL MOVE ON NOW TO OARAC EXPO F EX-OFFICIO MEMBERS. ROBERT EISINGER. >>I DON'T BELIEVE HE'S JOINING TODAY. >>THANK YOU. DR. VICTORIA DAVIE. >>UNFORTUNATELY DR. DAVIE IS UNABLE TO JOIN AS WELL. >>THANK YOU, MARY. MOVING ON DR. CARL DIEFFENBACH. >>GOOD MORNING, EVERYBODY. CARL DIEFFENBACH, DIRECTOR DIVISION OF AIDS AND NIAID. >>THANK YOU. DR. ROHAN HAZRA. IS DR. HAZRA WITH US? >>JOINING LATER. REAR ADMIRAL JONATHAN MERMIN. >>GOOD MORNING, I'M JONATHAN MERMIN DIRECTOR OF NATIONAL CENTER FOR HIV VIRAL HEPATITIS STD AND TD PREVENTION CDC. LOOK FORWARD TO THE MEETING. >>THANK YOU, DR. MERMIN. SO NEXT I'LL INTRODUCE KNEW NIDA ADVISORY COUNCIL REPRESENTATIVE. DR. MELANIE OTT OF THE GLADSTONE INSTITUTE OF VIROLOGY, UNIVERSITY OF CALIFORNIA SAN FRANCISCO. >>GOOD MORNING, EVERYBODY, MELANIE OTT DIRECTING THE GLADSTONE INSTITUTE OF VIROLOGY, PROFESSOR MEDICINE AT THE UC SAN FRANCISCO. THANK YOU. DELIGHTED TO BE HERE. >>THANK YOU. SO MOVING ON TO CURRENT ADVISORY COUNCIL REPRESENTATIVES. FOR THOSE WHO ARE HERE WITH ME PLEASE INTRODUCE YOURSELF WHEN I CALL YOUR NAME. DR. FRANCIS ALI-OSMAN. DR. MONICA GANDHI. >>MONICA GANDHI, PROFESSOR MEDICINE UCS STAFF AND ON NIAID ADVISORY COUNCIL. THANK YOU. >>THANK YOU. DR. MARGARITA LIGHTFOOT. >>GOOD MORNING, EVERYBO EVERYB. MARGUERITA LIGHTFOOT ASSOCIATE DEAN RESEARCH OHSU SCHOOL OF PUBLIC HEALTH REPRESENTING NIMH COUNCIL. >>THANK YOU. NEXT, I WILL MOVE TO OUR OAR LEADERSHIP AND SPEAKERS. DR. MAUREEN GOODENOW. GOOD MORNING. >>GOOD MORNING. >>REAR ADMIRAL TIMOTHY HULS. >>DEPUTY DIRECTOR OAR. >>CAPTAIN PARI GLENSHAW. >>GOOD MORNING, -- MARY GLENSHAW. >>GOOD MORNING, EVERYBODY. >>THANK YOU, DR. (INDISCERNIBLE) >>I'M GEETANJALI BANSAL. >>THANK YOU, DR. BANSAL. LASTLY, I -- I WILL INTRODUCE INVITED GUESTS WHO WILL LIKELY JOIN US LATER. SO I WILL START WITH MR. TIMOTHY WESTMORELAND. >>GOOD MORNING, TIM WESTMORELAND, PROFESSOR EMERITUS AT GEORGETOWN LAW SCHOOL. >>THANK YOU MR. WESTMORELAND. DR. RICHARD HODES. DR. STACY KIERINGTON LAWRENCE. HERE WITH US? DR. BASAL EL DADA. >>GOOD MORNING, PROGRAM OFFICER AT THE NATIONAL INSTITUTE ON AGING. >>THANK YOU. DR. JUDY LEVINSON DR. THEODORE RAUL. >>HE WILL BE JOINING LATER TOO >>THANK YOU. DR. ATHENA CURTIS JOINING LATER. DR. RONALD WILCOX. DR. RENEE (INDISCERNIBLE) WHO WILL JOIN LATER AS WELL. ROY GULICH (PHONETIC) JOINING LATER. LASTLY DR. HENRY BASUR (PHONETIC) WHO I ASSUME IS ALSO JOINING US LATER >>THAT'S CORRECT. >>ALL RIGHT. SO COLLEAGUES, IS THERE ANYONE THAT I DID NOT CALL OR THAT I MISSED? OKAY. OUR FIRST ORDER OF BUSINESS IS TO APPROVE THE MINUTE THE OCTOBER 2022 OARAC MEETING. YOU SHOULD HAVE RECEIVED THESE MINUTES ELECTRONICALLY IN YOUR BRIEFING BOOK. ARE THERE ADDITIONS OR CORRECTIONS TO THE MINUTES? HEARING NONE IS THERE A MOTION TO ACCEPT MINUTES AS THEY STAND? >>I MOVE WE APPROVE THE MINUTES AS THEY STAND. >>THANK YOU, DR. AKINTOBI. IS THERE A SECOND? >>I SECOND. >>THANK YOU. IS ANYONE OPPOSED TO APPROVING THE MINUTES AS THEY STAND? HEARING NONE THE MOTION IS PASSED, MINUTES ARE APPROVED SO THANK YOU, EVERYONE. AS A REMINDER, PER OUR CHARTER AND LEGISLATION, THE OARAC ADVISES THE OAR DIRECTOR ON BROAD MATTERS RELATING TO HIV RESEARCH POLICIES PRIORITIES AND STRATEGIC PLANNING INCLUDING THE REVIEW OF NIH AIDS RELATED PROGRAMS. NOW I WILL PROVIDE A BRIEF OVERVIEW OF TODAY'S AGENDA WHICH YOU CAN FIND AGAIN IN YOUR BRIEFING BOOK. REPORT FIRST BY OAR DIRECTOR. WE WILL HAVE A SPECIAL GUEST SPEAKER, MR. TIMOTHY WESTMORELAND. A PRESENTATION FROM THE DIRECTOR OF THE NATIONAL INSTITUTES OF AGING AND THE PROGRAM LEADERSHIP FROM NIH. ALSO HAVE A REPORT ON NIH OAR HIV AND AGING ACTIVITIES. AND UPDATE ON THE INFANT FEEDING FOR INDIVIDUALS WITH HIV IN THE UNITED STATES RECOMMENDATION. A PRESENTATION ON EXPANDING INCLUSION IN NIH TREATMENT TRIALS WORKSHOP. A PRESENTATION FROM THE DIRECTOR OF ADVANCE RESEARCH PROJECTS AGENCY FOR HEALTH ARPA H. UPDATES FROM THE ADVISORY NIH ADVISORY COUNCIL. AND UPDATES FROM THE OARAC HIV CLINICAL GUIDELINES WORKING GROUP. AS YOU CAN SEE WE HAVE A VERY BUSY SCHEDULE, HENCE THE EARLY START FOR TODAY. SO THE AGENDA WILL ALSO INCLUDE TIME FOR REGISTERED PUBLIC COMMENTS. SO ANYONE LISTENING IN TODAY WHO WISHES TO MAKE A PUBLIC COMMENT H WAS THERE A COMMENT? OKAY. SO IF YOU HAVE A PUBLIC COMMENT YOU SHOULD EMAIL DR. GLENSHAW AT OINFO@NIH.GOV. OARACINFO@NIH.GOV WITH YOUR QUESTION AND COMMENT. OR VISIT THE WEBSITE OR FEDERAL REGISTER NOTICE FOR MORE DETAILS. SO WE WILL NOW HEAR FROM DR. GOODENOW, DIRECTOR OF OFFICE OF AIDS RESEARCH WHO WILL INTRODUCE OUR SPECIAL GUEST SPEAKER THIS MORNING. DR. GOODENOW, OVER TO YOU. >>GREETINGS, AND THANK YOU ALL FOR JOINING US FOR THE 62ND NIH OARAC MEETING. THANKS, BLANTON FOR THE INTRODUCTIONS. THIS YEAR MARKS THE ANNIVERSARY OF ORGANIZATIONS THAT PLAY A CRUCIAL ROLE TO SAVE AND IMPROVE THE LIVES OF MILLIONS OF PEOPLE WITH HIV. WE SHOULD RECOGNIZE THE 20 YEARS OF SERVICE PROVIDED BY PEPFAR. THE 30TH ANNIVERSARY OF THE CONFERENCE ON REROW VIRUSES AND OPPORTUNISTIC INFECTIONS, CROI. 30 YEARS OF THE HRSA RYAN WHITE HIV AIDS PROGRAM. AND THE 35TH ANNIVERSARY OF THE NIH OFFICE OF AIDS RESEARCH. I WOULD LIKE TO START BY THANKING BLANTON TOLBERT, WHO HAS BEEN A MEMBER OF OARAC SINCE 2020 AND HAS SERVED AS THE OARAC CHAIR SINCE JUNE OF 2021. I ALSO WANT TO ACKNOWLEDGE THE FOLLOWING OARAC MEMBERS WHO ALONG WITH BLANTON, HAVE EXTENDED THEIR SERVICE WITH OUR THANKS AND WILL COMPLETE THEIR TURNS ON OARAC AS OF MARCH 29 THIS YEAR. THAT INCLUDES DR. MARGARET BRANDEAU, DR. HEIDI CRANE, AND DR. JONAH SACHA. THANK YOU VERY MUCH FOR YOUR CONTRIBUTIONS AND YOUR VALUABLE SERVICE. IT IS A PLEASURE TO INTRODUCE DR. IVY TURNBULL, NEW ACTING OARAC CHAIR. SHE WILL ASSUME HER DUTIES AS ACTING CHAIR BEGINNING MARCH 30TH. DR. TURNBULL IS DEPUTY EXECUTIVE DIRECTOR OF THE AIDS ALLIANCE FOR WOMEN INFANTS CHILDREN YOUTH AND FAMILIES AT THE AIDS INSTITUTE. LOOKING FORWARD TO WORKING WITH YOU, IVY. THANK YOU TO THOSE WHO PARTICIPATED IN YESTERDAY'S ORIENTATION. THE OARAC ORIENTATION IS AN ANNUAL EVENT AND THERE WILL BE AN OPPORTUNITY FOR THOSE WHO MISSED IT THIS YEAR TO PARTICIPATE NEXT YEAR. AGAIN, WELCOME TO DR. LOUISE MONTANA WHO IS WITH US TODAY FOR HIS FIRST AD HOC MEETING. SWITCHING GEARS, RELATED TO THE BUDGET, THE FY 2023 OMNIBUS BILL INCLUDES INCREASE OF $100 MILLION ABOVE THE FY 2022 AND ACTIVE LEVEL FOR E RESEARCH RELATED TO HIV AIDS ACROSS THE NIH. THIS IS A 3.1% OVER THE FY 2022 NIH HIV BUDGET WHICH ALSO INCLUDED INCREASE OF $104 MILLION. THE FY 2022 INCREASE WAS THE LARGEST SINGLE YEAR INCREASE SINCE FY 2014. OUR OVERALL SINCE 2018 THERE'S BEEN A $299 MILLION INCREASE IN THE NIH RESEARCH BUDGET FOLLOWING YEARS OF FLAT FUNDING. WORKING WITH THE NIH OFFICE OF DIRECTOR, THESE INCREASES WERE DEPLOYED ACROSS THE NIH HIV RESEARCH PROGRAM. THE FY 2022, $104 MILLION INCREASE WAS PRIMARILY ALLOCATED TO RESEARCH ASSOCIATED WITH TWO OF THE NIH PRIORITIES FOR HIV AND HIV RELATED RESEARCH. NAMELY, ADDRESS HIV ASSOCIATE T CO-MORBIDITIES, CO-INFECTIONS AND COMPLICATIONS, AS WELL AS THE CROSS-CUTTING RESEARCH PRIORITIES. THE FY 23, $100 MILLION INCREASE IS DEPLOYED TO NINE INSTITUTES TO SUPPORT PROJECTS IN ALIGNMENT WITH AREAS OF EMPHASIS OUTLINED IN THE FY 23 PROFESSIONAL JUDGMENT BUDGET. EACH YEAR OAR LEGISLATIVELY MANDATED TO DEVELOP HIV AIDS PROFESSIONAL JUDGMENT BUDGET WHICH HIGHLIGHTS ACCOMPLISHMENTS IN HIV AIDS RESEARCH DURING THE PRIOR YEAR. AND ESTIMATES THE AMOUNT OF ADDITIONAL FUNDS NEEDED TO ADVANCE PROGRESS AND PRIORITY AREAS OF SCIENCE AS OUTLINED IN THE CURRENT NIH STRATEGIC PLAN FOR HIV AND HIV RELATED RESEARCH. THE FY 2024 PROFESSIONAL JUDGMENT BUDGET FOR HIV AIDS RESEARCH REQUESTS $3.673 BILLION, AN INCREASE OF 470 MILLION OR 15% OVER THE FY 2022 ACTIVE BUDGET OF 3.4 MILLION OF AIDS RESEARCH AT THE NIH. SOME OF THE SCIENCE OPPORTUNITIES HIGH LIGHT LIGHTEN THE FY 24 INCLUDE AREAS EXPANDING BASIC BIOMEDICAL AND BEHAVIORAL RESEARCH, ALSO EMPHASIZES THE NEED TO UNDERSTAND BIOLOGICAL BEHAVIORAL SOCIAL CONDITIONS ASSOCIATED WITH EFFECTS OF HIV ACROSS THE LIFE SPAN. THE FY 24 PJ DESCRIBES WAYS ALSO TO STRENGTHEN THE CAPACITY AND DIVERSITY OF THE HIV AIDS RESEARCH WORK FORCE SUCH AS EXPAND POOL OF DIVERSE EARLY CAREER HIV INVESTIGATORS, AND IMPROVE AND UPGRADE INFRASTRUCTURE AND EQUIPMENT AT INSTITUTIONS CONDUCTING HIV AIDS RESEARCH PARTICULARLY THOSE WITH LIMITED RESOURCES. THE FULL TEXT OF THE FY 2024 NIH HIV AIDS PROFESSIONAL JUDGMENT BUDGET IS AVAILABLE ON THE OAR WEBSITE. IN THE LAST CALENDAR YEAR OAR HAS ACCELERATED THE DEVELOPMENT OF THE PJ BUDGETS TO ALIGN MORE CLOSELY WITH THE US GOVERNMENT BUDGET PROCESSES OVERALL. AND SO WHILE WE JUST RECENTLY POSTED THE FY 2024, WE ARE ALREADY DEVELOPING THE FY 25 PJ. THIS YEAR MARKS THE 35 -- 35 YEARS OF INNOVATIVE INTERDISCIPLINARY AND GLOBAL HIV AIDS RESEARCH PROGRAM THAT HAS TRANSFORMED HIV AIDS FROM A ONCE FATAL DISEASE INTO A MANAGEABLE CHRONIC CONDITION WITH TREATMENT. AS WE LOOK FORWARD TO THE FUTURE OF HIV AIDS RESEARCH, THE PUBLIC NEEDS OF THE COMMUNITIES AFFECTED BY HIV CONTINUE TO CHANGE ESPECIALLY AS PEOPLE LIVE AND AGE WITH HIV. OAR AGENDA NEEDS TO LOOK FORWARD TO WHAT IS NEEDED TO GET US ACROSS THE FINISH LINE AND END HIV AS BROAD EXPERTISE AND EXPANDED PARTNERSHIPS. IT IS NOW MY PLEASURE TO INTRODUCE A SPECIAL GUEST SPEAKER, MR. TIMOTHY WESTMORELAND. MR. WESTMORELAND SPENT THE EARLY PART OF HIS CAREER WORKING FOR THE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT OF THE U.S. HOUSE OF REPRESENTATIVES UNDER THE CHAIRMANSHIP OF CONGRESS HENRY WAXMAN. WHO IS FROM CALIFORNIA. THERE HE STAFFED HEARINGS AND LEGISLATION ON PUBLIC HEALTH, HIV AIDS, REPRODUCTIVE HEALTH BIOMEDICAL RESEARCH, BIOMEDICAL ETHICS AND HEALTH REGULATION AND IN THIS ROLE HE WAS ONE OF THE AWE ORS OF THE LEGISLATION THAT CREATED THE OAR IN 1988. FOLLOWING HIS TIME IN CONGRESS MR. WESTMORELAND MOVED TO GEORGETOWN LAW AND APPOINTED DIRECTOR OF THE MEDICAID AND CHIP PROGRAMS IN THE DEPARTMENT OF HEALTH AND HUMAN SERVICES UNDER PRESIDENT CLINTON. MR. WESTMORELAND IS CURRENTLY PROFESSOR FROM GEORGETOWN UNIVERSITY LAW CENTER WHERE HE TAUGHT FROM 2001 TO 2022. HE HAS TAUGHT HEALTH LAW, IF ED RAIL BUDGETS AND LEGISLATION, HE SERVED MANY ADVISORY ROLES INCLUDING KEISER FAMILY FOUNDATION AND ELIZABETH GLASER PEDIATRIC AIDS FOUNDATION WHICH IS WHERE TIM AND I MET YEARS AGO MY FIRST GRANT WAS FROM THE PEDIATRIC AIDS FOUNDATION. AND SO IT IS GREAT TO HAVE YOU HERE, TIM. VERY EXCITED TO HEAR SOME OF YOUR REFLECTIONS ON THE START OF OAR. WE WILL PUT THE SLIDES OFF FOR NOW. >>OKAY. THANK YOU. FIRST I WANT TO SAY THANK YOU TO MAUREEN AND OTHERS FOR THE INVITATION. WHEN I STARTED WORKING ON HIV ISSUES IN THE FALL OF 1981, THERE WAS A TIME I FELT LIKE I KNEW EVERY HIV RESEARCHER BY NAME. THEN THE FIELD GREW AND IT IS NICE TO BE BACK. I NEED TO BEGIN WITH COUPLE OF DISCLAIMERS. I INTEND THESE TO BE INFORMAL REMARK, I'LL HAVE NO FOOT NOTES, NO SLIDES, JUST TALKING. I'M A SOUTHERN PREACHERS KID. AND THE VIEWS I EXPRESS ARE MY OWN. THEY SHOULDN'T BE CONSTRUED TO BE THOSE OF PAST, PRESENT AND MAYBE SOME DAY FUTURE EMPLOYERS. THEN FINALLY, PROBABLY MOST SIGNIFICANTLY, THESE EVENTS THAT I'M REMINISCING ABOUT FOR YOU, TOOK PLACE A LONG TIME AGO AND MY MEMORY IS AGING SO I'M SURE SOME OF IT IS FLAWED. BEFORE I TALK ABOUT OAR FOUNDING, I NEED TO SET SOME CONTEXT HOW WE WERE WORKING AT THE TIME. THIS WAS A LONG TIME AGO AND THINGS WERE REALLY VERY DIFFERENT. MR. REGA REAGAN WAS PRESIDENT, MEMBERS OF CONGRESS WERE QUITE BLUNT SAYING THEY DIDN'T LIKE GAY MEN AND DIDN'T CARE WHAT PARTED TO THEM. THE WHITE HOUSE PRESS SEC WAS EXCHAINING CRUDE AIDS JOKES WITH THE PRESS CORP. THE FIRST LEGISLATION I WORKED ON FOR AIDS FUNDING FRAMED GENERICALLY ABOUT PUBLIC HEALTH EMERGENCIES BECAUSE MY SENATE REPUBLICAN COUNTER PART WAS UNSURE WHETHER IT WOULD SHORT CONVOY VERSEIAL RESEARCH. THEN OF COURSE AS YOU KNOW THERE WAS WILD CONFUSION ABOUT WHAT THE DISEASE WAS. FOR YEARS NO ONE COULD EVEN IDENTIFY AN INFECTIOUS AGENT. SOME MEMBERS OF CONGRESS WHOM I WORKED WITH WERE CONVINCED THAT IT WAS SPREAD BY MOSQUITOES AND WE HAD TO COMMISSION A TECHNICAL REPORT TO RESPOND TO THAT. A FEW OF THEM STAYED OUT OF THE HOUSE GYM BECAUSE THEY WERE AFRAID OF SWEAT. ONE NEWS MAGAZINE RAN A COVER, NOW WE ARE ALL AT RISK FOR AIDS. ANOTHER PREDICTED THE INSURANCE INDUSTRY WOULD NOT SURVIVE THE EPIDEMIC. PEOPLE WITH AIDS LOST THEIR JOBS, THEIR HOMES, AND THEIR FAMILIES. KIDS WERE KEPT OUT OF SCHOOL. AND ALL THIS WITHOUT LEGAL RECOURSE IN MOST STATES. ACROSS THE BOARD THE REAGAN ADMINISTRATION WAS OPPOSING ALL INCREASES IN FUNDING NOT JUST ON AIDS BUT EVEN ON POLIO VACCINES AND TUBERCULOSIS CONTROL. NO NEW MONEY EXCEPT FOR DEFENSE. THE WHITE HOUSE THREATENED A VOTE TOE AN APPROPRIATIONS BILL IN PART BECAUSE IT HAD TOO MUCH AIDS RESEARCH MONEY IN IT. WE HAD IN THE SUBCOMMITTEE ON HEALTH, HEARING AFTER HEARING ON WHAT RESEARCHERS AND PUBLIC HEALTH AUTHORITIES THOUGHT WAS NEEDED. I HAVE TO ACKNOWLEDGE THIS WAS ALL BEFORE THE INTERNET AND EVEN MO BEFORE EMAIL SO I GT DOCUMENTS AND LEAKS OF INTERNAL BUDGET PROPOSAL THE PUBLIC HEALTH SERVICE AND ITS OFFICERS, IN PLAIN BROWN ENVELOPES. OFFICIAL WITNESSES LIKE TONY FAUCI AND JIM KERNS FROM CDC HAD TO SUPPORT THE OFFICIAL ADMINISTRATION BUDGET BUT OVER TIME WE DEVELOPED A MENUETTE OF QUESTIONS WHERE WE CAN SAY WHAT PRESIDENT SUPPORTED AND MEMBERS OF CONGRESS COULD ASK THEM IN YOUR PERSONAL PROFESSIONAL JUDGMENT WHAT WOULD BE NEEDED TO RESPOND. WITH THAT KIND OF QUESTION OFFICIALS COULD RESPOND. USUALLY REPEATING WHAT THE AUTHORITY RECEIVED IN THE PLAIN BROWN ENVELOPES. EVENTUALLY THE PRESS AND PUBLIC BEGAN TO AGREE THAT MORE HAD TO BE DONE. AND ON A BIPARTISAN BASIS THE CONGRESS CONTINUED TO INCREASE NIH AND CDC FUNDING FOR AIDS WORK. BY 1987 THE HOUSE BUDGET RESOLUTION PROPOSED DOUBLING THE AIDS RESEARCH BUDGET. AFTER ALREADY DOUBLING IT THE YEAR BEFORE. BUT AT THE SAME TIME THE OMB AND THE OFFICE OF PERSONNEL MANAGEMENT WERE IMPOSING PERSONNEL CEILINGS MAKING HARDER TO EXPEDITE RESEARCH AWARDS OR DO INTRAMURAL WORK. AS YOU NO BETTER THAN I -- KNOW BETTER THAN I WHEN THE FUNDING WAS APPROVED AIDS RESEARCH WAS BEING CONDUCTED IN EVERY NIH INSTITUTE AND CENTER. EVEN COUNTING THE GRANTS IN THE PROJECTS FOR AIDS AND RELATED RESEARCH WAS DIFFICU DIFFICULT.H LESS FOLLOWING IT. THERE WAS DUPLICATION. ALLERGY, CANCER WERE DOING SOME OF THE SAME PROJECTS. AND THERE WERE GAPS AND OMISSIONS OF IMPORTANT ISSUES THAT PEOPLE SIMPLY WEREN'T STUDYING. AND THERE WAS NO OVERALL COORDINATED PLAN FOR AIDS RESEARCH. SO IN 1988, THE CONGRESS BEGAN NEW LEGISLATION. THERE WAS ONE VERY HIGH PROFILE BILL TO CREATE A FEDERAL GRANTS PROGRAM FOR HIV COUNSELING AND TESTING. AND TO PROVIDE FOR CONFIDENTIALITY AND NON-DISCRIMINATION TO ENCOURAGE PEOPLE TO BE TESTED. THERE WAS A SECOND ONE TO IMPROVE AIDS RESEARCH AUTHORITIES, INCLUDING EXPEDITING RESEARCH AWARDS, INCREASING THE PERSONNEL FOR AIDS RESEARCH, CREATING AN ANNUAL REPORT TO THE CONGRESS ON THE RESEARCH, AND CODIFYING OFFICE OF AIDS RESEARCH IN ORDER TO COORDINATE NIH AIDS ACTIVITY AND REPORT ON THEM. MOST OF THE CONGRESSIONAL DEBATE AND CONTROVERSY WERE ABOUT THE FIRST BILL THOUGH NEW DRUGS FOR PREVENTING OPPORTUNISTIC INFECTIONS, NOT ALL OF THE AIDS ACTIVISTS SUPPORTED FEDERAL ENCOURAGEMENT OF TESTING. FOR THE RIGHT WING AMENDMENT AFTER AMENDMENT WAS PROPOSED TO REQUIRE MAUNDSTORY TESTING AND REPORTING OF NAMES. THE PEOPLE WHO DIDN'T LIKE GAY MEN WERE OPPOSED TO THE NON-DISCRIMINATION PROVISIONS, SAYING THAT THE TESTING BILL WAS A SECRET GAY RIGHTS BILL. AND BEFORE THE DEBATE PROTECTIONS -- BEFORE THE DEBATE, THOSE PROTECTIONS HAD TO BE DROPPED TO MAKE THE BILL BIPARTISAN. BUT THE REAGAN ADMINISTRATION ALSO OPPOSED RESEARCH PROVISIONS SAYING THEY WERE ALL MICROMANAGEMENT THAT WAS UNNECESSARY. AS ALWAYS THE OMB SAID ALL THAT COULD BE DONE WAS BEING DONE. THE SENATE HAS IS NOT PASSED BILL ON CONFIDENTIALITY, THEY WERE TOO CONTROVERSIAL. WE TRIED TO GET SENATE AGREEMENT IN CONFERENCE BUT JESSIE HELMS I DESCRIBE IN MY PERSONAL VIEWS AS THE 80s EQUIVALENT OF TED CRUZ AND RAND PAUL WRAPPED INTO ONE, THREATENED TO VETO THE WHOLE PACKAGE, THAT WAS TOO MUCH PROTECTION OF PEOPLE WITH AIDS FOR HIM TO ACCEPT. AND ANY BOSS, MR. WAXMAN SAID HE COULDN'T SUPPORT A FEDERAL TESTING PROGRAM THAT DIDN'T PROSECT CONFIDENTIALITY SO THE TESTING AND TITLE OF THE BILL HAD TO BE DEVELOPED DROPPED IT CAME BACK LATER AS THE RYAN WHITE ACT IN 1990 BUT NOT PART OF THE LARGE LEGISLATION IN 1988. BUT THE OAR AND OTHER RESEARCH PROVISIONS WERE PASSED AND ENACTED, ON A BIPARTISAN BASIS. AS TIME WENT ON IT BECAME CLEAR THAT OAR COULD NOT GET THE ATTENTION OF INSTITUTES WHEN THEIR SPENDING PLANS. IF I MAY, MONEY TALKS EVEN WITHIN THE NIH. THERE WAS DISCUSSION OF CREATING AN AIDS INSTITUTE IN THE CONGRESS, THE AIDS BUDGET WAS ALREADY LARGER THAN A NUMBER OF THE EXISTING INSTITUTES. AND THERE MIGHT BE COORDINATING AND PLANNING BENEFITS FROM WORKING WITHIN ONE STRUCTURE. THERE ARE ALSO SIGNIFICANT DISADVANTAGES OF UPROOTING SCIENCE, SCIENTISTS AND LABS, AND DISRUPTING COORDINATION AND COMMUNICATION. THERE WAS A POLITICAL FEAR, A POLITICAL FEAR, OF A PROLIFERATION OF DISEASE SPECIFIC INSTITUTES AT NIH. SO BY 1992 THERE WAS HYBRID STRUCTURE DEBATED IN THE CONGRESS AND INSTITUTE WITHOUT WALLSWALLS WAS THE PHRASE. KEEPG THE WORK AND PEOPLE WITHIN EXISTING INSTITUTES AND CENTERS, COORDINATING FUNDING DECISIONS TO INSTALL GAPS AND OVERLAPS. A NUMBER OF OUTSIDE SCIENTISTS AND ADVOCATES WERE SUPPORTIVE. BUT THE INSTITUTE DIRECTOR HAROLD VARMUS AND TONY FAUCI WERE OPPOSED AND THAT MATTERED ON THE HILL AND PRES PRESS. I TALKED TY BEING HEAD OF SUCH AN INSTITUTE WHICH HE DIDN'T WANT. BUT HE DIDN'T WANT THE OAR TO HAVE ANY CONTROL OF THE BUDGET EITHER. NONETHELESS THE STRUCTURE WAS INCORPORATED INTO THE NIH REVITALIZATION ACT OF 1982. THAT ACT, HAD CENTRAL CONTROVERSY, NOT THE OAR, IT WAS NOT THE REQUIREMENT TO INCLUDE WOMEN AND RACIAL ETHNIC MINORITIES IN CLINICAL TRIALS SUPPORTED BY NIH. IT WAS LIFTING THE MORATORIUM ON NIH SUPPORT OF FETAL TISSUE TRANSPLANTATION WHICH WAS BANNED BY NIH CELL TORR HEELEY, THAT WAS THE FRONT PAGE NEWS WITH PARKINSON AND DIABETES GROUPS LINED UP AGAINST ANTI-ABORTION GROUP GROUPS BILLS VETOED OVER FETAL TISSUE BY PRESIDENT BPRESIDENT BUSH. THE S OVERWRITTEN IN THE SENATE, SOMETHING THAT ALMOST NEVER HAPPENS AND INCLUDED SIGNIFICANT SUPPORT FROM REPUBLICANS. WE FAILED TOOVER RIDE IN THE HOUSE, HAVING A CLEAR MAJORITY TO DO SO BUT NOT THE TWO-THIRDS REQUIRED THEN MR. CLINTON MADE THE BUSH VETO AN ELECTION ISSUE PROMISING TO SIGN IT AND LIFTING THE FETAL TISSUE RESEARCH MORATORIUM BY EXECUTIVE ORDER. THE BILL -- THE NIH REVITALIZATION ACT PASSED INCLUDING STRENGTHENING OAR WITH BUDGET AUTHORITY. SEEMS A LONG TIME AGO, AND I'M NOW THOROUGHLY OUT OF TOUCH WITH THE FIELD THAT YOU ARE THE LEADERS IN. I DON'T KNOW EVERY AIDS RESEARCHER BY NAME ANY MORE. AND I DON'T KNOW THE ONGOING RESEARCH AND THOSE PROJECTS THAT ARE WAITING IN THE WINGS. BUT I ASSUME AND LISTENING TO YOUR AGENDA, I KNOW, THAT THE ORGANIZATIONAL PARADOXES ARE STILL MUCH THE SAME. HOW TO COORDINATE WORK OVER MULTIPLE INSTITUTES AND CENTERINGS WITH MULTIPLE CONSTITUENCIES AND HOW TO MAKE SCIENTIFIC PROGRESS OVER SO MUCH POLITICAL CONTROVERSY. I KNOW YOU HAVE GOT GOOD LEADERSHIP AND I WISH YOU LUCK. MAUREEN. >>THANKS, TIM, THAT WAS GREAT. REALLY GOOD TO SEE YOU, JUST SO EVERYONE KNOWS WE WILL HAVE TIME DURING THE DISCUSSION AFTER I FINISH MY REMARKS THAT WE CAN -- IF ANYONE HAS COMMENTS PARTICULARLY OR QUESTIONS FOR TIM, HE'S STILL ON LINE WITH US. SO LOOKING FORWARD, I WANT TO BRING UP ABOUT LISTENING SESSIONS, WHICH ARE CRITICAL TO ACCOMPLISHING THE HIV OAR MISSION. IF I CAN GET BACK TO MY RIGHT SCREEN, THERE WE ARE. OAR LISTENING SESSIONS WITH COMMUNITY PARTNERS PROVIDE DATA, USED TO ENSURE THE NIH HIV RESEARCH PROGRAM IS FLEXIBLE AND THAT RESEARCH PRIORITIES ARE RESPONSIVE TO THE EMERGING CHALLENGES AND NEEDS. OAR IS FINALIZING A THIRD LISTENING SESSION REPORT WHICH WILL COVER SESSIONS HELD BETWEEN AUGUST 2021 AND DECEMBER 2022. THESE SESSIONS WERE HELD IN D.C. HOUSTON TEXAS, SAN JUAN PUERTO RICO AND MON STRE MONTREAL, CANN PARTICULAR SAN JUAN AND MONTREAL WAS IN PERSON THE FIRST OUTS OF DC FOR MOST OF US. MAJOR THEMES THAT EMERGED DURING THESE SESSIONS INCLUDE TOPICS DIRECTLY OR SUPPORTED IN EXPANSION OF HIV RESEARCH WORK FORCE INFRASTRUCTURE, AND RESOURCES OTHER THEMES INCLUDING HIV ACROSS THE LIFE SPAN, SOCIAL STRUCTURAL FACTORS THAT IMPACT HIV RISK AND UPTAKE OF SERVICES, CULTURAL COMPETENCE AND COMMUNITY ENGAGEMENT IN HIV RESEARCH. INFORMATION DISSEMINATION BOTH FOR HEALTH EDUCATION AND FOR RESEARCH FINDINGS. SO I LOOK FORWARD TO YOUR THOUGHTS REGARDING THE OAR LISTENING SESSIONS DURING THE DISCUSSION FOLLOWING THIS PRESENTATION. LISTENING SESSIONS WITH FEDERAL ACADEMIC AND COMMUNITY PARTNERS CONTINUE TO GUIDE OAR FOCUS ON SPECIAL AREAS OF INTEREST TIED TO THE NIH HIV RESEARCH MISSION. IN THE CURRENT PRIORITIES FOR HIV AND HIV RELATED RESEARCH. WE CALL THESE AREAS OF HERSELF SIGNATURE PROGRAMS AND I'M GOING TO BRIEFLY HIGHLIGHT A FEW OF THEM AND SOME OF THE ACTIVITIES SINCE OUR LAST OARAC MEETING. THE OAR SIGNATURE PROGRAMS SHOWN IN THIS SLIDE PLAY A SIGNIFICANT ROLE IN GUIDING ACTIVITIES AND THEY ARE MULTI-DISCIPLINARY AND OPEN TO ALL NIH ICOs. TODAY'S OARAC AGENDA HIGHLIGHTS THE HIV AGING SIGNATURE PROGRAM, AND SHORTLY WE WILL BE HEARING FROM THE NATIONAL INSTITUTE ON AGING DIRECTOR DR. RICHARD HODES WHO WILL REVIEW NIH HIV AGING RESEARCH PRIORITIES AND PLANS AND WE WILL ALSO HEAR FROM OAR HEALTH SCIENTIST ADMINISTRATOR DR. GEETANJALI BANSAL WHO WILL REPORT ON THE NIH OAR HIV AND AGING ACTIVITIES. FUTURE OARAC MEETINGS WILL FEATURE UPDATES ON ACTIVITIES ASSOCIATED WITH THE OTHER THREE SIGNATURE PROGRAMS. WITH THE GROWING NUMBER OF PEOPLE AGING WITH HIV, WE ANTICIPATE THE NEED FOR GREATER SUPPORT IN THE FUTURE. THE AGING AND HIV SIGNATURE PROGRAM AIMS TO CATALYZE COLLABORATION TO ADDRESS RESEARCH GAPS AND OPPORTUNITIES AT THE INTERSECTION OF HIV AND AGING. A TOTAL OF 17 INSTITUTES CENTERS AN OFFICES SUPPORT THE MULTI-FACETED HIV AND AGING PORTFOLIO. WITH ESTIMATED FUNDING FOR RESEARCH IN FY 2022, FOR THIS AREA ABOUT $119 MILLION. IN THE FY 2023 OMNIBUS BILL REPORT, CONGRESS ENCOURAGED OAR TO FUND INTERDISCIPLINARY RESEARCH AND TRAINING PROGRAMS IN HIV AND AGING. THERE WAS A DISCUSSION YESTERDAY FOR THOSE WHO HEARD IT ABOUT THE IMPACT OF REPORT LANGUAGE ON HOW THE BUDGET IS SPENT. OAR HAS PARTNER WITH THE NATIONAL INSTITUTE ON AGING TO FORM THE NIH HIV AGING WORKING GROU GROUP. WITH REPRESENTATION FROM NIH INSTITUTES CENTERS AND OFFICES THAT SUPPORT THIS RESEARCH. THIS GROUP AIMS TO STRENGTH HAD BEEN STRATEGIC PARTNERS ACROSS AGENCY, ACADEMIA AND COMMUNITY ORGANIZATIONS TO ENSURE THAT NIH RESEARCH IS IN LINE WITH COMMUNITY NEEDS AND CULTURAL PREFERENCES. AFTER HEARING MORE ABOUT HIV AND AGING RESEARCH AND ACTIVITIES, TODAY'S AGENDA FEATURES A PRESENTATION ON UPDATES TO RECOMMENDATIONS ON INFANT FEEDING FOR INDIVIDUALS WITH HIV IN THE UNITED STATES AND OTHER UPDATES TO THE HIV CLINICAL PRACTICE GUIDELINES. WE ARE GOING TO BE HEARING ABOUT EXPANDING INCLUSION IN HIV TREATMENTS TRIALS, AND ALSO THE PRESENTATION ON ADVANCE RESEARCH PROJECTS AGENCY FOR HEALTH OR ARPA H. THIS IS A NEW MULTI-DISCIPLINARY PROGRAM INCLUDED ON THE AGENDA AS PARTS OF THE OAR ONGOING SERIES TO HIGHLIGHT EXISTING NIH RESOURCES THAT CAN BE LEVERAGED TO ADVANCE HIV RESEARCH. IN PREVIOUS OARAC MEETINGS, WE FEATURED NIH RESOURCES SUCH AS THOSE FOUND WITHIN THE NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING NIBIB, THE NATIONAL CENTER FOR ADVANCE TRANSLATION SCIENCES AND THE ALL OF US RESEARCH PROGRAM. AFTER ARPA H WE WILL HEAR UPDATES THROUGH NIH ADVISORY COUNCIL REPRESENTATIVES AND THE NIH CLINICAL GUIDELINES WORKING GROUPS. SO THANK YOU FOR MAKING THESE MEETINGS A PRIORITY. THE NEXT MEETING OF OARAC IS SCHEDULED JUNE 22ND, AND AT THIS TIME OAR IS PLANNING FOR THIS TO BE A HYBRID MEETING. SO SOON AS WE CAN CONFIRM ALL DETAILS FOR THOSE ARRANGEMENTS WE WILL INFORM EVERYONE. WE ARE VERY EXCITED, LOOKING FORWARD TO HAVING THIS OPPORTUNITY. SO WITH THAT, I REMIND YOU THAT THERE ARE MANY WAYS TO STAY CONNECTED WITH OAR AND ACTIVITIES, AND IF I COULD SAY A FEW REMARKS IN CLOSING BEFORE TURNING THIS BACK TO BLANTON. FOR 35 YEARS OAR COORDINATED NIH OAR AGENDA CONVENING PARTNERS TO CATALYZE INTERDISCIPLINARY EFFORTS. OUR GOAL REMAINS THE SAME. TO END THE HIV PANDEMIC AND IMPROVE THE HEALTH OF PEOPLE WITH HIV. WE MUST FOCUS ON ACTION TO PREVENT, TO TREAT, AND TO CURE HIV. THESE ACTIONS WILL REQUIRE CONTINUED COMMITMENT INNOVATION AND CREATIVITY. TO REDUCE ANY EFFORTS NOW INEVITABLY LEAD TO RESURGENCE HIV WORLDWIDE. COMPROMISING GLOBAL HEALTH IN THE 21ST CENTURY. WE MUST REMAIN NIMBLE TO RESPOND TO NEW CHALLENGES, LEVERAGE NEW AND EXISTING PARTNERSHIPS, AND ENSURE ALL VOICES CAN CONTRIBUTE. THESE ACTIONS REQUIRE CONTINUED COMMITMENT INNOVATION AND CREATIVITY. TO REDUCE -- WE MUST BUILT BILLION DOLLAR ON OUR ROBUST REPERTOIRE OF OPTIONS TO IMPROVE PREVENTION AND TREATMENT STRATEGIES. MEANWHILE, THE SCIENTIFIC AGENERAL DA WILL CONTINUE -- AGENDA WILL CONTINUE, INNOVATIVE RESEARCH AND IMMUNOLOGY VIROLOGY, BEHAVIORAL AND SOCIAL SCIENCES. AS WELL AS IMPLEMENTATION SCIENCE RESEARCH WHICH IS KEY FOR DISSEMINATION OF RESEARCH DISCOVERIES TO THE COMMUNITIES WHO BENEFIT THE MOST. ENDING THE HIV EPIDEMIC PANDEMIC IS AN AMBITIOUS BUT FEASIBLE GOAL. THANK YOU. BLANTON, BACK OVER TO YOU FOR DISCUSSION. >>THANK YOU, MAUREEN, FOR A WONDERFUL PRESENTATION AND ALSO TIM, FOR THE REMARKS IN HISTORICAL CONTEXT. COLLEAGUES WE HAVE ABOUT 20 MINUTES FOR DISCUSSION AND CONVERSATION. I ALREADY SEE A HAND UP. BEFORE I GO OVER TO YOU, DR. AKINTOBI, I WANT TO ASK MR. WESTMORELAND A QUESTION JUST A LEAD-OFF QUESTION. I ALSO WANT TO SHARE THAT I'M ALSO A SOUTHERN BRIEFER'S KID SO I APPRECIATE YOUR PRESENTATION STYLE -- PREACHER'S KID. I APPRECIATE YOUR SOUTHERN PRESENTATION STYLE. GIVEN YOUR EXPERIENCE, ARE THERE ANY LESSONS, BEST PRACTICES OR PARALLELS THAT YOU LEARNED FROM HIV AIDS AND THE CURRENT PANDEMIC THAT YOU MIGHT CAN COMMENT ON? >>AS ALL OF US KNOW, THE CURRENT PANDEMIC AND HIV HAVE A LOT OF DIFFERENCES BETWEEN THEM. THERE ISN'T THE LEVEL OF STIGMA, THERE'S NOT THE LEVEL OF IGNORANCE, THERE'S PLENTY OF PUBLICITY TO GO AROUND. SO THOSE THINGS ARE QUITE DIFFERENT. THE THING THAT I THINK THE CONGRESS COULD LEARN IS SOMETHING THAT MY BOSS USED TO TELL ME WHEN I WORKED FOR THE HOUSE. WHICH WAS HE WANTED ME TO THINK OF MYSELF AS A PUBLIC HEALTH SERVICE EMPLOYEE WHO DIDN'T HAVE TO RESPOND TO THE OMB IN THE WHITE HOUSE. SO I WAS SUPPOSED TO CONVEY TO HIM AND THE CONGRESS -- AND WE TRIED TO MAKE THE CONGRESS FOLLOW THAT, WHAT WAS YOU NOW REFER TO AS PROFESSIONAL JUDGMENT OF THE PUBLIC HEALTH FIGURE, AND NOT TRY TO SUBS INSTITUTE AND MICROMANAGE FROM THE CONGRESSIONAL LEVEL WHAT WAS THE NEXT BEST THING TO DO. BY ACTING AS IF I WERE A PHS EMPLOYEE, I GOT SOME PEOPLE GOT SOME CONFIDENCE THAT THE CONGRESS WAS LISTENING TO THEM. SO THOSE PLAIN BROWN ENVELOPES CONTINUE TO COME. I WOULD SAY THE CONGRESS SHOULD LEARN TO LISTEN TO EXPERTS AND NOT TRY TO FREELANCE ON THEIR OWN. YOU ARE MUTED. >>I'M SORRY, I WAS SAYING THANKS FOR SHARING AND I APPRECIATE YOU RESPONDING TO A QUESTION THAT WAS SLIGHTLY OUTSIDE OF THE SCOPE OF YOUR PRESENTATION. I WANT TO GO BACK NOW AND ACKNOWLEDGE THE HANDS FROM MY COLLEAGUES. DR. AKINTOBI. >>THANK YOU VERY MUCH, DR. TOLBERT. I WANTED TO FIRST THANK DR. WESTMORELAND FOR HIS INSIGHTS AND JUST THE IMPORTANCE OF US REMEMBERING THE HISTORY AND THE POLITICS RELATED TO HOW WE GOT HERE, I THINK IT IS IMPORTANT FOR US AS WE THINK ABOUT THE FUTURE, THE OARAC AND IMPORTANT WORK WE ARE DOING IN HIV RESOURCES. SO THANK YOU SO MUCH FOR THAT. DR. GOODENOW, MIGHT YOU SHARE AN EXAMPLE OF TWO TO REMIND US OR ORIENT A FEW OF OUR MEMBERS HOW THE COMMITTEE LISTENING SESSIONS HAVE TRANSLATED INTO ANY TYPE OF ACTION. I THINK THAT IS IMPORTANT. THE LISTENING IS CRITICAL TO UNDERSTANDING EXAMPLES OF HOW THEY MADE THEIR WAY INTO DECISIONS RELATED TO THE DIVISION OF OARAC I THINK IS EVEN MORE IMPORTANT. IF YOU COULD SHARE AN EXAMPLE OR TWO, PLEASE. >>THANKS FOR THAT QUESTION. REALLY, I THINK THE BEST EXAMPLE TRANSLATING WHAT WE HEARD INTO ACTION IS DEVELOPMENT OF FOUR SIGNATURE PROGRAMS. IN PARTICULAR HIV AND AGING OR HIV ACROSS THE LIFE SPAN AND FOR THE EARLY CAREER INVESTIGATORS, THOSE THEMES WERE -- HAVE BEEN HEARD FROM EVERY PLACE WE HAVE BEEN IN DIFFERENT WAYS BUT THOSE ARE ABSOLUTELY THE MOST I WOULD SAY RECURRING THEMES. EVEN THOUGH WE HEAR SIMILAR PIECES OF INFORMATION AND GET DIFFERENT -- SIMILAR INSIGHTS FROM DIFFERENT COMMUNITIES, I THINK THE REALLY IMPORTANT ASPECT OF LISTENING SESSIONS IS THAT IT ALSO GIVES US SOME OF THE RARE COMMENTS THAT WE DON'T ALWAYS HEAR. JUST BECAUSE IT MIGHT BE ONE OR TWO INDIVIDUALS MAKING THE COMMENT, IT DOESN'T -- THIS IS NOT A POPULARITY OR INFORMAL POLL TO HOW MANY QUICK VOTES WE GET BUT TO BE ABLE TO LISTEN AND TO HEAR ALL THE VOICES THAT COME TOGETHER IN DIFFERENT WAYS, THAT HELP TO GUIDE THE PROGRAMS THAT WE ARE SPONSORING WITH MORE EMPHASIS. >>THANKS FOR THE QUESTION, DR. AKINTOBI AND MAUREEN, FOR THEIR RESPONSES. GOOD TO KNOW THE FOUR SIGNATURE PROGRAMS YOU DISCUSS ARE A PRODUCT OF LISTENING TOURS. SO I WANT TO MOVE ON NOW TO DR. MONTANAIR. >>THANK YOU, GOOD MORNING, MAUREEN. REALLY INSPIRING HISTORY LESSON, AMAZING HOW MUCH WE ADDRESS THE SAME ISSUES AS YOU NOTED IN A DIFFERENT SCALE. I WANT TO SHARE WITH EVERYONE THAT I HAVE THE PLEASURE TO JOIN MAUREEN AT THE LISTENING SESSION SAN JUAN PUERTO RICO, IT PROVIDED A FIRSTHAND ACCOUNT AS TO WHAT THE OUTCOME OF THESE LISTENING SESSIONS ARE AT LEAST FOR THIS PARTICULAR COMMUNITY. I WANT TO STRESS IT WAS QUITE IMPACTFUL EXERCISE, FIRST IT BROUGHT TOGETHER ALL THE NIH FUNDED INVESTIGATORS THAT HAVE NOT OTHERWISE ACTUALLY COME TOGETHER AS A GROUP. WITH RESPECT TO COMMON PURPOSE OR MISSION IN THE CONTEXT OF THE AIDS AGENDA. IT ALSO PROVIDED A LOT OF UNFILTERED COMMENTS FOR MAUREEN AND HER STAFF. A LOT OF SIGNATURE PROGRAMS THAT WERE ALREADY HIGHLIGHTED AS AN OUTCOME OF'S THESE LISTENING SESSIONS. HE ALSO HAD THE OUTCOME THAT IT ACTUALLY IDENTIFIED COMMON THEMES WITHIN THE GROUP THAT WERE GEOGRAPHICALLY NOT IN THE SAME LOCATION. WHICH THEN PROMPTED DISCUSSIONS ABOUT COLLABORATION AND INTEGRATION AND COALITION BUILDING. SO I THINK THAT THE LISTENING SESSION THAT I ATTENDED WAS VERY IMPACTFUL, VERY PRODUCTIVE AND HAD LONG STANDING OUTCOMES. SO I WANT TO COMMEND MAUREEN'S OFFICE FOR SPONSORING THIS PROGRAM AND ENCOURAGE THAT YOU WOULD CONTINUE. THANK YOU. >>THANKS FOR SHARING THAT, DR. MONTANARA. THAT IS QUITE POWERFUL TO HEAR. TO HEAR THE OUTCOMES OF THAT. MOVING ON DR. SLEASMAN. >>I WANT TO FOLLOW ON WHAT LUIS WAS TALKING ABOUT IN TERMS OF LISTENING SESSION. ENGAGEMENT OF STAKEHOLDERS IN RESEARCH AGENDA IS ABSOLUTELY CRITICAL TO MOVING FORWARD AND DEVELOPING HOW THE NEXT PHASE OF THE OAR HIV RESEARCH AGENDA. I AM INVOLVED IN THREE DIFFERENT ADVOCACY GROUPS OUTSIDE OF HIV, ONE IS THE JEFFREY (INAUDIBLE) FOUNDATION, THE OTHER PRIMARY (INDISCERNIBLE) FOUNDATION, NATIONAL KIDNEY FOUNDATION, ALL ARE FOUNDATIONS THAT ARE HIGHLY ENGAGED IN PATIENT ADVOCACY AND A LOT OF DISCUSSIONS AROUND FOR EXAMPLE COVID VACCINES AND COVID IN PEOPLE WHO ARE HIGHLY SUSCEPTIBLE. I HAVE TO THANK THE CDC, THE CDC IS INVOLVED IN THESE LISTENING SESSIONS THEY COME TO EVERY SINGLE ONE OF THEM. THE FRAMEWORK WE DEVELOPED WAS AROUND OAR HAS DONE IN THE HIV WORLD SO OAR IS LEADING THE FIELD AND SADLY NOT SEEN HIV REPRESENTATION IN THESE GROUPS BUT I THINK THAT SOMETHING I WOULD RECOMMEND IS ALL NIH NEEDS TO BE MORE INVOLVED WITH THE COMMUNITY BASED GROUPS GOING FORE AND NOT HOLD BACK. >>DR. SLEASMAN, DR. GANDHI. >>THANK YOU SO MUCH. THAT WAS EXTREMELY POWERFUL, DR. WESTMORELAND, YOUR RECOUNTING THE EARLY HISTORY OF WHAT HAPPENED IN CONGRESS. THE REASON THAT I THINK WE DO HAVE TO THINK ABOUT THE CURRENT PANDEMIC, AN WHAT HAPPENED IN CONGRESS, WITH HIV IS MY UNDERSTANDING IS DESPITE WHAT HAPPENED WITH THE TERRIBLE STIGMATIZATION AND TERRIBLE POLICIES BEGINNING OF '80s TOWARDS HIV THE DENTS OF CERTAIN PERSONALITIES DID LEAD TO BIPARTISAN SUPPORT OF HIV AND THAT WAS THROUGH FIRST CARE IN 1990 AND PIPFAR IN 2003. -- PEP FAR IN 2003. NO WAY AROUND THE BIPARTISAN, THERE NEEDS TO BE BIPARTISAN SUPPORT BECAUSE THEY ARE THE ONES, CONGRESS IS THE ONE WHO WRITES CHECKS, THEY ARE THE ONES WHO FUND OUR ORGANIZATIONS. SO IT FEELS LIKE I THINK WHAT I HAVE BEEN WATCHING IN THE NEWS IS IT FEELS LIKE THERE IS ONE SIDE IS RIGHT, ONE SIDE IS WRONG ON COVID AS OPPOSED TO COULD WE WORK WITH MEMBERS OF CONGRESS THAT ARE ON THE OTHER SIDE TO GET THIS BIPARTISAN MOVEMENT BECAUSE IT WORKED, I KNOW IT TOOK A LONG TIME, NINE YEARS AT LEAST FROM 1981 TO RYAN WHITE CARE BUT IT DID HAPPEN. I THINK IT WAS REALLY STRONG PERSONALITIES THAT ARGUED PASSIONATELY FOR THE NEEDS FOR BIPARTISAN SUPPORT OF HIV WHICH WAS NOT GOING AWAY, NEITHER IS COVID. >>YOU ARE COMPLETELY CORRECT. ALL THESE THINGS HAD TO HAPPEN ON A BIPARTISAN BASIS. AIDS POLICY AND AIDS POLICY ACT NIH REVITALIZATION ACT, RYAN WHITE THOSE THINGS HAD SIGNIFICANT REPUBLICAN LEADERSHIP. WHEN YOU TALK ABOUT PEPFAR, IT WAS THE REPUBLICAN LEADERSHIP THERE. I WISH I COULD POINT YOU TOWARDS SOME INSIPIENT BIPARTISAN SHIP GOING ON IN THE CONGRESS RIGHT NOW BUT AT THIS POINT I DON'T THINK YOUR REVIEW OF THE NEWS IS WRONG. I THINK THE SCORCHED EARTH WEAN THE TWO PARTIES IS HARD TO GET PAST. I WILL HAVE TO -- WHEN I WORKED UP THERE, THERE WERE MODERATE REPUBLICANS AND MODERATE DEMOCRATS AND NOW THERE ARE ONLY PEOPLE WHO THINK THEIR PARTY IS THE ONLY ANSWER. SO I DON'T KNOW. WE ARE ALL STRUGGLING FIGURING HOW TO DO THIS BUT I THINK YOU ARE RIGHT. I THINK WE WON'T HAVE A SIGNIFICANT BREAK THROUGH IN LEGISLATION UNTIL WE DO GET IT. >>YES. THANK YOU. >>MR. WESTMORELAND, THANK YOU. MOVING ON NOW TO DR. TURN BULL. >>I WANT TO TAKE THE OPPORTUNITY TO THANK YOU, DR. WESTMORELAND FOR ALL THE WORK THAT YOU HAVE DONE, PARTICULARLY ON BEHALF OF THE OARAC. YOU HAD YEARS AND YEARS OF SERVICE. THANK YOU VERY MUCH. >>MY PLEASURE. >>DR. GOODENOW, I -- IN TERMS OF THE SIGNATURE PROGRAMS, THE SPECIFIC QUESTION AROUND THE LISTENING SESSIONS, I WAS WONDERING DURING THOSE LISTENING SESSIONS THAT YOU HAVE HAD WONDERING IF THE SUBJECT OR CONVERSATIONS, HAD PARTICULARLY AROUND INFANTS WHO WERE BORN WITH HIV, WHO ARE NOW ADULTS 35 AND 40 AND WHETHER OR NOT THAT CATEGORY WILL FALL INTO THE SIGNATURE PROGRAM OF HIV AND AIDS, PARTICULARLY SINCE THERE WAS A CAVEAT TO THAT INITIATIVE AND THAT SAYS OVER 50. IF THEY ARE NOT THERE, WHERE WILL THEY BE? >>SO YES WE CERTAINLY HAVE HEARD THAT GROUP REFERRED TO AND THOSE PERINATALLY EXPOSED BUT NOT INFECTED INDIVIDUALS AND THOSE WHO WERE INFECTED PERINATALLY. AS THEY AGE WITH HIV. ONE OF THE GOOD PIECES OF NEWS IS THAT BECAUSE OF TREATMENT OF SOME OF THESE BABIES WEREN'T ABLE TO GO ON TO ANTI-RETROVIRALS VERY EARLY IN THEIR LIVES AND SOME OF THEM ARE NOW PARENTS OF THEIR OWN FAMILIES AND THEIR CHILDREN ARE NOT HIV INFECTED. BUT YES IN TERMS OF THE AGING ISSUE, THE AGING TOPIC, WE REALLY THINK ABOUT HIV ACROSS THE LIFE SPAN. THE AGE TIME OR LENGTH OF INFECTION TIME IS NOT REALLY THE CRITICAL FACTOR AND THEY ARE NOT HARD DIVISIONS OF GROUPS INTO DIFFERENT SUB GROUPS. . I THINK THIS IS DEFINITELY A MORE FLUID KIND OF COVERAGE IF YOU WILL, ACROSS THE LIFE SPAN, THERE'S DIFFERENT FEATURES OF THE LIFE SPAN AND FOR DIFFERENT PEOPLE CERTAINLY WOMEN HAVE DIFFERENT ISSUES THAN MEN AGING WITH HIV AND SO I THINK HAVING SOME OF THESE PEOPLE AT THE TABLE DURING SOME OF THE LISTENING SESSIONS, I THINK THE LISTENING SESSION WE WANT TO THAT YOU HELPED SPONSOR IN NEW YORK, BEFORE THE PANDEMIC, I REMEMBER SPECIFICALLY THERE WERE ONE OR TWO YOUNG PEOPLE THERE WHO HAD BEEN PERINATALLY INFECTED. IT WAS VERY, VERY POWERFUL TO HAVE THEIR INPUT. AND TO THE DISCUSSION WE HAVE THERE. THANK YOU FOR THAT. >>THANK YOU. >>DR. MILLER. >>THANKS. FIRST OF ALL I DID WANT TO THANK DR. TIM WESTMORELAND FOR YOUR WONDERFUL PRESENTATION AND BRINGING US REALLY ILLUSTRATING FOR US WHAT CAN HAPPEN AS VERONICA SAID WHEN THE RIGHT STRONG VOICES REALLY CHIMED IN. IT REMINDS ME ALSO OF THE LEADERSHIP OF (INDISCERNIBLE) IN THOSE DAYS AND YOU REMEMBER MAYBE REMEMBER WE DO HAVE THE PUBLIC HEALTH LEADERSHIP AWARD WHICH WE AWARDED TO CONGRESSMAN WAXMAN. IT WAS TONY FAUCI WHO PRESENTED THAT AWARD TO HIM. VERY UNIQUE EXAMPLE OF PUBLIC HEALTH LEADERSHIP IN THOSE DAYS. THANK YOU FOR ALL OF YOUR WORK. I WANTED TO SIMPLY ECHO WHAT JOHN SLEASMAN WAS SAYING BEFORE ABOUT LISTENING TOURS AND THE MODEL FOR THIS, THE PATIENT, NOT THE PATIENT ONLY BUT ALSO THE COMMUNITIES WHERE PATIENTS LIVE. IMPORTANT TO HOW WE DEAL WITH A DISEASE ACHRONIC DISEASE LIKE HIV IS SO IMPORTANT AND HIV THAT HAS BEEN IS GROUND BREAKING AND HOW TO DO THAT. YOU MENTIONED THERE SHOULD BE A BROADER NIH APPROACH AND I WANTED TO ECHO THAT. THANK YO THANK YOU. >>THANK YOU, DR. MILLER. THESE LISTENING TOURS ARE CERTAINLY POPULAR AND LEADING THE WAY, SOUNDS LIKE. MAUREEN, I HAVE A COUPLE OF QUESTIONS MYSELF RELATED TO THE LISTENING TOURS. IN THE SECOND TIME I WANT TO MAYBE ASK ONE, RELATED TO WHAT YOU MIGHT HAVE BEEN HEARING FROM THE EARLY CAREER INVESTIGATORS AND MY QUESTION IS ABOUT THIS CHALLENGE THAT WE HAVE NOW WITH POST-DOCS WHO ARE DECIDING TO LEAVE ACADEMIA AND TAKE POSITIONS IN INDUSTRY. HAVE YOU HEARD ANYTHING FROM THAT GROUP ON YOUR LISTENING TOURS IN TERMS OF WHY THEY MAYBE MAKING THIS DECISION AND WHAT TYPE OF INCENTIVES CAN KEEP THEM IN ACADEMIC SCIENCE. CERTAINLY WHEN WE HAVE THE LISTENING SESSIONS, ONE APPROACH WE TAKE IS TO WORK WITH SUBGROUPS OF PEOPLE, MEETINGS WITH COMMUNITY PEOPLE SEPARATE FROM THE ACADEMIC COMMUNITY, FOR TWO REASONS. ONE IS TO KEEP THE GROUP SMALL. AND NOT HAVE HUGE ROOMS WHEN WE ARE STILL MEETING IN PERSON BUT EVEN LOTS AND LOTS OF PEOPLE ON THE SCREEN BECAUSE IT REALLY DOES HELP THE CONFERENCE THE GROUPS HAVE 15, 20 PEOPLE IN THEM. SO MORE GROUPS. THERE'S DIFFERENT COMMENTARIES AND YOU HEAR THE DIFFERENT NUANCES BETWEEN DIFFERENT GROUPS OF INDIVIDUALS. SO WITHIN THE ACADEMIC CONVERSATIONS WE HAD, THE POST-DOCS HAVE BEEN MENTIONED AND SOMETIMES THERE ARE ACTUALLY POST-DOCS THERE. I THINK THERE ARE AMONG THEM MORE SHIER GROUP TO SPEAK UP ESPECIALLY WHEN THEIR FACULTY IS PRESENT AND THAT'S SOME OF THE THINGS WE CAN TIE IN TERMS OF TRYING TO BREAK IT OUT MORE. WHAT WE HAVE BEEN FOCUS CANNING ON HAS BEEN EARLY CAREER INVESTIGATORS, PEOPLE WHO ALREADY HAVE PASSED THROUGH POST-DOCTORAL TRAINING AND ARE STARTING AT FACULTY POSITIONS. THE CHALLENGES THEY FACE IN GETTING THEIR FIRST GRANTS AND THE NUANCES OF REVIEWS AND SCIENTIFIC MERIT COMMENTARIES AND THINGS LIKE THAT. THE ISSUE NOW WITH THE POST-DOCS THAT IS ARISING IS REALLY IMPORTANT AND I THINK IT WILL DEFINITELY BE COMING UP MORE IN OUR LISTENING SESSIONS. BECAUSE WE REALLY HAVE TO LOOK AT THE WHOLE PIPELINE. PEOPLE HAVE TALKED TO US ABOUT FROM CLINICAL RESEARCH SIDE HOW IMPORTANT THE K AWARDS ARE, THERE IS ALSO A LOT OF CHALLENGES WITH K AWARDS AND REALLY ACHIEVING THE GOALS OF SUPPORTING CAREER DEVELOPMENT LUIS TALKED TO US AT ONE POINT ABOUT SOME OF THE THINGS THEY HAVE BEEN HEARING ABOUT K AWARDS AND HOW THEY COULD POTENTIALLY BE STRUCTURED DIFFERENTLY. THE WHOLE DEVELOPMENTAL, THE WHOLE PIPELINE OF DEVELOPING SCIENCE AND SCIENTIFIC INVESTIGATORS REALLY NEEDS TO BE LOOKED AT AS TO WHERE CONSTRICTIONS AND WHAT THE DIFFERENT SOLUTIONS ARE, BECAUSE CLEARLY, WORKING IN DIFFERENT SECTIONS OF THE PIPELINE REQUIRE DIFFERENT TYPES OF APPROACHES. I AGREE WITH YOU AND WHAT IS HAPPENING FOR THE FIELD BIOMEDICAL RESEARCH, IT IS NOT SPECIFIC TO HIV BUT CERTAINLY IMPACTING THE AGENTS IN THE FIELD. THANK YOU FOR COMMENTING ON THAT QUESTION. DR. SLEASMAN, YOUR HAND IS UP, DO YOU HAVE ANOTHER QUESTION? >>I DON'T I THOUGHT I LOWERED IT. >>I WANT TO GET US BACK TO THE AGENDA. DR. GOODENOW I BELIEVE I HAND THIS BACK TO YOU TO INTRODUCE OUR NEXT SPEAKER IN THE SESSION. >>YES. SO OUR NEXT PRESENTATION IS FROM THE DIRECTOR OF THE NATIONAL INSTITUTES ON AGING. DR. RICHARD HODES. IS REALLY A GREAT PLEASURE TO INTRODUCE HIM TODAY. DR. HODES DIRECTS THE NIA NATIONAL INSTITUTE ON AGING, HE IS LEADING IMMUNOLOGIST WHO IS NAMED NIA DIRECTOR IN 1993. TO OVERSEE STUDIES OF THE BIOLOGICAL CLINICAL BEHAVIORAL AND SOCIAL ASPECTS OF AGING. UNDER DR. HODES STEWARDSHIP THE NIA BUDGET HAS GROWN TO NEARLY 1.6 BILLION REFLECTING INCREASE PUBLIC INTEREST IN AGING AS AMERICA AND THE WORLD GROWS OLDER. DR. HODES DEVOTE HIS TENURE TO DEVELOPMENT OF STRONG DIVERSE AND BALANCED RESEARCH PROGRAM FOCUS ON GENETICS AND BIOLOGY OF AGING BASIC CLINICAL STUDIES RELATED OR AIMED TO REDUCE DISEASE AND DISABILITY INCLUDING ALZHEIMER'S DISEASE AND AGE RELATED COGNITIVE CHANGE. THE INVESTIGATION OF THE BEHAVIOR ON SOCIAL ASPECTS OF AGING. ALSO THESE EFFORTS HAVE A GOAL, IMPROVING THE HEALTH AND QUALITY OF LIFE FOR OLDER PEOPLE AND THEIR FAMILIES. THANK YOU, RICHARD FOR BEING HERE AND TURN THE FLOOR OVER TO YOU. >>THANK YOU. IT IS A GREAT PLEASURE TO BE HERE. I WANT TO STRESS THE CLOSE RELATIONSHIP WE HAVE HAD BETWEEN NIA AND YOUR OFFICE. AND MORE BASICALLY, THE RELEVANCE OF HIV TO AGING RESEARCH. THE NEXT FEW SLIDES I WILL TRY TO EMPHASIZE THAT, AFTER MY PRESENTATION SOME OF MY PROGRAM STAFF CLOSELY INVOLVED WILL GET ON TO FURTHER CONVERSATION. NIA MOSTLY APOLOGIZE FOR THE FACT I CAN'T BE WITH YOU AND ADVISORY COUNCIL LONGER DO CONFLICTING COMMIT COMMITMENTS. CAN WE GO TO THE NEXT SLIDE PLEASE. >>THIS IS A -- THE MISSION STATEMENT THAT ACCOMPANY THE ESTABLISHMENT OF NIA. I SHOW YOU HERE BECAUSE IT DOES EXPRESS THE BREADTH OF RESPONSIBILITIES FOR THE AGING INSTITUTE. IN TERMS OF SUPPORTING RESEARCH, I WILL COME BACK TO THIS REPEATEDLY, THIS RELATES TO RESEARCH MOST BIOLOGIC MOLECULAR LEVELS, THROUGH CLINICAL BEHAVIOR, SOCIAL ECONOMIC RESEARCH. THAT TOO REFLECTS THE BREADTH OF OVERLAPPING INTEREST IN HIV AND AGING. WE ALSO FOSTER CAREER DEVELOPMENT AND TRAINING, RESOURCES ROLE AND DISSEMINATE INFORMATION TO THE PUBLIC. NEXT SLIDE PLEASE. THE APPROPRIATION HISTORY OF NIA IS REMARKABLE, YOU SEE IN THE NEXT SLIDE THE APPROPRIATION FOR 2023 NIH OVERALL $47.7 BILLION, THE NIA BUDGET FOR THIS CURRENT YEAR IS 4.4, $1 BILLION WITH GROWTH I WILL SHOW YOU THAT MAKES NIA THE THIRD LARGEST OF INSTITUTES BEHIND NCI AND NIAID. THE INCREASE THIS YEAR TARGETED NUMBER OF AREAS BUT ONE OF THE LARGEST OF THOSE IS AGAIN INCREASE IN FUNDING ALLS MER'S DISEASE AND DEMENTIA, ADRD $26 MILLION TO NIH OVERALL FOR THAT. THE NEXT SLIDE PLEASE. THIS SHOWS YOU THE PACE WHICH THE BUDGET HAS INCREASED. SO AS RECENTLY AS 2015, OVER A BILLION DOLLARS TO WHERE WE ARE NOW AS MENTIONED $4.4 BILLION, THIS HAS BEEN A GROWTH INCLUDED A LARGE COMPONENT SHOWN IN BLUE HERE, THIS IS THE COMPONENT THAT IS THE ACCRUED OR AGGRAVATED OF TARGETED INCREASES WHICH CONGRESS COMMITTED TO ALZHEIMER'S RELATED DEMENTIA RESEARCH, OVERALL BUDGET INCREASE DRAMATICALLY, IN PARTICULAR AD AND ADRD AND THIS HAS IMPLICATIONS FOR RESEARCH SUPPORT. NOW, I WANT TO EMPHASIZE ONE ASPECT OF GROWTH THAT HAS BEEN STRONG IN MIND DURING OUR COMMITMENT IS TO MAKE SURE THAT WE ARE RECRUITING PEOPLE FROM DIVERSE BACKGROUNDS Z ACROSS ALL DEMOGRAPHIC DIMENSIONS BUT ALSO IN TERMS OF SCIENTIFIC DISCIPLINES, TO MOST APPROPRIATELY GROW PRODUCTIVELY APPROACH TO AD AND ADRD, IMPORTANT TO DRAW UPON TALENTS OF PEOPLE WITH IN MANY AREAS. ONE OF THE PROGRAMS, ONE ILLUSTRATED HERE IS A SUPPLEMENT PROGRAM IN WHICH WE NIA WILL FUND ADMINISTRATIVE SUPPLEMENTS TO GRANTS SUPPORTED BY ANY NIH INSTITUTES, THOSE GRANTS MUST BE NON-AD ADRD THEMSELVES. THOSE FOR WHICH A CASE CAN BE MADE FOR SUPPLEMENT TAKE ADVANTAGE OF EXPERTISE AND CONTENT MATTER OF THOSE GRANTS SUPPLEMENT IN A WAY TO BECOME RELEVANT TO AD AND ADRD. THE SHORT TERM GOAL IS RESEARCH OF GREAT DIVERSITY, RECRUITED TO THE FIELD AND LONGER TERM AS BEGINNING TO SEE NOW DEVELOPMENT OF MORE AND MORE INVESTIGATORS BROUGHT INTO THE FIELD FROM THAT STRATEGY. YOU CAN SEE ESSENTIALLY ALL THE NIH INSTITUTES HAVE BEEN PARENTS PATING THE LAST YEAR OVER 200 SUPPLEMENTS AND $75 MILLION INVESTED. THIS IS REFLECTED AS WE TRACK IT IN THE FACT FROM 2015 THROUGH 2022, WHERE WE HAVE THESE DATA AND THE DRAMATIC INCREASE IN APPROPRIATIONS AND BUDGET, OF THAT PERIOD ONE-THIRD OF ALL OF OUR AWARDEES WERE EITHER NEW OR EARLY STAGE INVESTIGATORS AND THOSE DEFINITIONS ARE PROBABLY WELL KNOWN TO YOU, A FIFTH IN THE CATEGORY WE NEWLY ESTABLISHED AND DEFINED NEW TO THE FIELD. THIS IS INVESTIGATORS NEVER APPLY FOR ANY RESEARCH OF ANY KIND RELATED TO AD ADRD AT ALL. I THINK SERVES US WELL TO BRING IN RESEARCHERS INCLUDING THOSE STRONG IMPORTANT INTERFACE BETWEEN HIV RESEARCH AND AGING. NEXT SLIDE. SO AS HAS BEEN CRITICAL IMPORTANT INTENSIFYING THEME ACROSS NIH AND NATIONALLY, HEALTH DISPARITIES FRAMEWORK IS IMPORTANT TO NIA QUITE SOME TIME. THIS IS A HEALTH DISPARITIES RESEARCH FRAMEWORK. I WILL POINT OUT PUBLISHED IN 2015. AND THE AUTHORS THIS CAME FROM NIA BUT INCLUDED MARIE BERNARD WHO LEADS NIA -- NIH WIDE EFFORTS IN THIS DOMAIN WAS THE DEPUTY DIRECTOR NIA FOR 13 YEARS, BUT TO MOVE TO TAKING THIS AT THE NIH LEVEL, ANOTHER CO-AUTHOR NOTED IS ELISEO PEREZ STABLE. WENT ON TO BECOME DIRECTOR OF NIMHD. A LONG COMMITMENT AND EMPHASIZE IT ISN'T JUST HEALTH DISPARITIES AT SOCIETAL OR SOCIO CULTURAL LEVEL BUT BEHAVIORAL RESEARCH AND BIOLOGIC RESEARCH ACROSS THE MATRIX TO ADDRESS AREAS RELEVANT TO DIVERSITY DISPARITIES AND EQUITY ACROSS THE FULL SPECTRUM OF RESEARCH. SOME OF THE PROGRAMS, THAT HAVE BEEN OVER THE PAST YEARS A MEANS FOR ACHIEVING THESE GOALS, A NATIONAL STRATEGY FOR RECRUITMENT AND PARTICIPATION OF PARTICIPANTS IN ALZHEIMER'S AND RELATED DEMENTIA RESEARCH HUGE EFFORT THAT'S BEEN INSUFFICIENT TO DATE. AND WHERE SUCCESS IS ABSOLUTELY UNSATISFACTORY. SO WE ARE LOOKING FOR MORE BETTER AND MORE EFFECTIVE WAYS TO RECRUIT DIVERSE POPULATIONS INTO RESEARCH, REFLECT THE POPULATIONS THAT OF COURSE ARE RELEVANT FOR RESEARCH AND LEARNING ABOUT RESEARCH AND ULTIMATELY THOSE TARGETS OF WHAT WE LEARNED IN TERMS OF IMPROVED INTERVENTIONS. YOU CAN SEE SOME OF THESE SPECIFIC AREAS HERE TRYING TO PROVIDE RESOURCES TO THE FIELD TO MAKE EASIER FOR INVESTIGATORS TO TAILOR TARGETS FOR RECRUITMENT AS THEY WORK AND THE LAST BULLETED HERE CHROMES CLINICAL RESEARCH SYSTEM, FIRST TIME GIVING NEAR REAL TIME ABILITY TO TRACK RECRUITMENT AND DEMOGRAPHICS TO ALL OUR CLINICAL TRIALS, WHICH IS GOING TO ALLOW TO PROVIDE HELP AND ASSISTANCE THOSE INVESTIGATORS NOT NEEDING GOALS AN TARGETS NOT END OF YEAR OR TWO OF PROGRESS REPORTS BUT REAL TIME. SO TRY TO ENHANCE EFFICIENCY OF RECRUITMENT EFFORTS. TURN FIRST TO SOME ASPECTS OF INTERSECTION OF HIV AND AGING AND REPEAT FOLLOWING MY PRESENTATION, YOU WILL BE HEARING FROM SENIOR NIA STAFF WHO HAVE BEEN MOST INVOLVED IN THIS INTERACTION AND PROVIDING MORE EXAMPLES OF CURRENT ONGOING WORK TOGETHER. HERE VERY VIVIDLY IS THE WELL KNOWN TO YOU, ALL OF US, THE FACT THAT AGING IS RELEVANT TO HIV AT THE LEVEL OF THE EPIDEMIOLOGY AND DEMOGRAPHICS OF INFECTION ITSELF SO 50% OF PEOPLE WITH HIV IN THE U.S. IS OVER 50 AND A LOT OF THIS IS PEOPLE ACQUIRED HIV INFECTION EARLY AGE TO SURVIVE AGES OVER 50 BUT ALSO 17% OF NEW INFECTIONS REMAIN THOSE IN POPULATIONS OVER 50. SO OUR DIVERSE EFFORTS WORKING WITH OAR ARE TO PROMOTE HEALTHY AGING AMONG OLDER ADULTS WITH HIV ACROSS THE WHOLE BREADTH OF BIOLOGIC THROUGH BEHAVIORAL SOCIAL RESEARCH MENTIONED IN THE PRIOR COMMENTS. GERO SCIENCE IS RELEVENCE TO THIS. IT SPRINGS THE REALIZATION AND AFFECT HYPOTHESIS THAT MANY CHANGE OCCUR WITH AGING OVER DOMAINS THAT INCLUDE A VARIETY OF MOLECULAR AND BIOLOGIC CHANGES WHERE IN COMMON TO THE ETIOLOGIES OF MULTIPLE DISEASE AND CONDITIONS. MULTIPLE DISEASE AND CONDITIONS HAVE AS A COMMONALITY THE FACT AGING IS A RISK FACTOR. FOR HIV, THIS RELATES TO THE WAY WHICH HIV INFECTION AND IMPORTANTLY NOT JUST HIV INFECTION BUT TREATMENT OF HIV INTERACTS WITH THE AGING PROCESS, APPEARS SOME CASES TO ACCELERATE CHANGES WHICH OCCUR DURING AGING. SO THE COMPLEX BIOLOGICAL REPACKS WITH AGING AND AGE AND HIV INFECTION IS EXCITED TO RESEARCH AND GERMANE TO UNDERSTANDING THE PROCESSES THAT WE CAN ADDRESS THEM IN REAL WORLD PRACTICAL CLINICAL OUTCOMES. NEXT PLEASE. SOME EXAMPLES, OF HIV AGING RESEARCH, I SHOW THIS AGAIN, THIS IS ORGANIZATIONAL STRUCTURE TO EMPHASIZE THAT THE RELATIONSHIP SPANS ALL, DIVISION OF BIOLOGY, CHANGES THAT OCCUR IN TERMS OF ALTERED IMMUNE RESPONSE WITH AGING, INFLAMMATORY RESPONSE. ALTERATIONS IN PROTEIN FOLDING AND SENESCENCE OF CELLS ARE BASIC BIOLOGY OF AGING. DIVISION OF NEUROSCIENCE, NOW LARGEST AREA INCLUDES BUT NOT LIMITED TO THE AD ALZHEIMER'S DEMENTIA THAT I MENTIONED, HAS NOTED CRITICAL INNEVER RELATIONSHIPS BETWEEN HIV AND INFECTION AND PATHOLOGY OF NEURODEGENERATION. DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY, THE FACT THAT COMPLEXITY OF CLINICAL CHALLENGES PEOPLE AS THEY AGE INVOLVE CO-MORBIDITIES, IN PARTICULAR FOR A DISCUSSION TODAY HIV INFECTION INTERRELATES WITH CO-MORBIDITIES OF AGING CRITICALLY IMPORTANT PART TO UNDERSTANDING HOW TO BEST MANAGE AND SERVE OLDER ADULTS WITH HIV. DIVISION OF BEHAVIORAL SOCIAL RESEARCH AS WE LOOK NOT JUST AT THE BEHAVIORAL ASPECT OF HIV INFECTION OR RESPONSE TO TREATMENT BUT ALSO WAY WE ASSESS THE HEALTHCARE SYSTEMS AND INFRASTRUCTURE, IMPORTANT TO HOEING HOW TO BEST PROVIDE CARE AND SERVICES FOR OLDER ADULTS INCLUDING THOSE WITH CO-MORBIDITIES AND MORE SPECIFICALLY FOR TODAY INCLUDING THOSE WITH HIV INFECTION. NEXT PLEASE. SOME OF THE PRIORITY AREAS HERE TO TOUCH ON THESE BULLETS, UNDERSTANDING THE INTERACTION BETWEEN GENETIC CELLULAR CHANGES AND HIV INFECTION UNDERSTANDING THOSE MECHANISMS THAT ARE RELATED TO THE CO-MORBIDITIES THAT OCCUR WITH AGING, UNDERSTANDING THE CONTRIBUTIONS OF INDIVIDUAL DIFFERENCES AND STRUCTURAL INSTITUTIONAL FACTORS, INCLUDING IMPORTANT SOCIAL INEQUITIES AND DISPARITIES WAY HIV MANIFESTS ITSELF HOW WE EFFECT AND BEST ADDRESS THE NEEDS OF PEOPLE WITH HIV INFECTION. THE RELATION OF HIV INFECTION AND COGNITIVE DECLINE IS MORE ACUTE SPECIFIC LATELY AND I KNOW IN PAST CONVERSATION COVID INFECTION AS ANOTHER VIRAL INFECTION AND THERE TOO THE IMPACTS ON THE NERVOUS SYSTEM, COGNITIVE DECLINE BUT HIV LONG STANDING FOCUS WHICH WE HAVE HAD IMPORTANT COLLABORATIONS. UNDERSTANDING THE ASSESSMENT OF TREATMENT IN OLDER INDIVIDUALS WITH HIV WHICH POLYPHARMACY OTHER DRUGS IN RESPONSE TO HIV TREATMENT ITSELF IS INFLUENCED BY AGING PROCESS. NEXT PLEASE. ANNOUNCEMENTS AND INITIATIVES I'M REFERRING TO THE CENTRAL OF HEALTH DISPARITIES DIVERSITY AND APPROACHING STRUCTURAL RACISM. HERE TOO WE HAVE HAD A LONG STANDING AND VERY PERSONAL INTEREST IN MANY ASPECTS HERE. I GUESS FOR DISCUSSION TODAY PERHAPS NEW RESEARCH, THE N IN UNITE. THE NEW RESEARCH IN HEALTH DISPARITIES MINORITY HEALTH INEQUITIES AS THEY APPLY TO HIV INFECTION IMPORTANT PART OF OUR PARTNERSHIP BETWEEN NIA AND OAR. AND THERE WAS TALK EARLIER ABOUT THE STATE OF TRAINEES, CAREER DEVELOPMENT POST-DOCTORAL FELLOWS, AND BALANCE BETWEEN THOSE GOING TO ACADEMIC CAREERS AN THOSE CHOOSING PRIVATE SECTOR INDUSTRY AND OTHER AREAS. I WOULD COMMENT HERE THAT AS WE KNOW IT IS ONLY MINORITY FRACTION OF THOSE PEOPLE WITH MANY BIOMEDICAL Ph.D. DEGREES END UP IN PROFESSIONAL ACADEMIC CAREERS. AND WITH THIS IN MIND AS WELL AS CHALLENGE OF DIVERSITY INCLUDING THE DIVERSITY OF OUR WORK FORCE WE INITIATED LAST YEAR, I THINK NEW INNOVAR ITIVE PROGRAM WHICH WAS A STARTUP CHALLENGE TO FOSTER DIVERSITY AND INNOVATION IN THE AREAS OF RESEARCH THAT ARE ENTREPRENEURIAL. ON TOP OF THE UNDERREPRESENTATION OF MANY GROUPS IN THE BIOLOGIC WORK FORCE ACADEMICALLY, IT IS MORE PROFOUND IN IN SMALL BUSINESS LARGE BUSINESS PHARMA AND ENTREPRENEURIAL AREAS SO WHAT WE DID IS ESTABLISH INITIATIVE WHICH HAD 200 PEOPLE INITIALLY RESPONDING. PROVIDED WITH MENTORS, FOR THOSE WHO HAVE EXPERTS IN THE FIELD OF ENTREPRENEURIAL RESEARCH IN BUSINESS, THEY WENT THROUGH A CHALLENGE THAT INVOLVED THEIR PROPOSING THEIR OWN RESEARCH AREAS. HAVING EXPERT ASSISTANCE IN GUIDANCE FOR WHAT IT MEANS TO BE ENTREPRENEURIAL TO PROVIDE TO POTENTIAL FUNDERS TO UNDERSTAND WHAT IT MEANT -- MEANS TO HAVE RESEARCH THAT DOES HAVE TRANSLATIONAL PERSPECTIVE. THOSE WE CAME DOWN TO 20 FINALISTS, SELECTED FOR A BOOT CAMP WHICH WAS QUITE INTENSIVE OVER WEEKS IN WHICH THEY WORKED WITH MENTORS TO COME UP WITH PROPOSALS. AND THEN FROM THOSE THE TOP FIVE RECEIVED A $60,000 AWARD TO ALLOW THEM TO FURTHER BEGIN DEVELOPMENT OF A SMALL BUSINESS APPLICATION WHICH THEN WOULD COME TO NEA OR OTHER RESEARCH INSTITUTES WITH CONTINUED MENTORING. LONG TERM. IT IS ENORMOUSLY SUCCESSFUL, THE PICTURES OF 2022 CHALLENGE WINNERS AND REPEAT THE PROGRAM IN 2023. SO AS WE SHARE COMMITMENT TO TRY TO MAKE THE PATHWAY FOR ACADEMIC RESEARCH TO BE AS RECEPTIVE AS IT CAN, WE ARE EQUALLY COMMITTED TO SUPPLYING THE NEEDS OF PRIVATE SECTOR DOING THAT IN AREA WHERE INCREASED DIVERSITY INCLUSION IS VERY MUCH NEEDED. NEXT SLIDE. SOME OTHER PROGRAMS MANY OF YOU MAY BE AWARE OF BUTLER WILLIAM PROGRAM, THE WEEK LONG IMMERSION PROGRAM NIA RESPONDER SOD FOR YEARS, NEW TO THE FIELD PEOPLE, JUNIOR FACULTY DOCTORAL DEGREE, A VERY STRONG EMPHASIS ON DIVERSITY AND DISPARITIES RESEARCH. THE MEETINGS HAD BEEN IN PERSON I WILL COVID BUT LAST TWO YEARS HAVING VIRTUAL TURNED OUT EXTREMELY PRODUCTIVE WITH FEEDBACK REVIEWS. SO IN 2023 PUBLIC HEALTH VIRTUALLY AS WELL AND ENCOURAGE THOSE OF YOU TO THINK ABOUT WAYS WHICH YOU YOUR STUDENTS AND SCHOLARS MIGHT BE INTERESTED IN PROFIT FROM THE PROGRAM, THE LINK IS SHOWN HERE AND OPEN FOR APPLICATIONS THROUGH NEXT MONTH. NEXT PLEASE AROUND ALZHEIMER'S RESEARCH WE HAD ANNUAL SUMMITS THAT ARE IN SERIES OF TWO THREE YEAR FOR EACH KINDS OF SUMMITS. ONE IS ALZHEIMER'S RESEARCH SUMMIT AND OTHER IS ALZHEIMER'S RELATED DEMENTIA SUMMIT AND THIRD WHAT IS HAPPENING THIS YEAR, A SUMMIT FOCUSED ON CARE SERVICES SUPPORT PEOPLE LIVING WITH DEMENTIA AND CARE PARTNERS AND CAREGIVERS. THIS IS MARCH 20, 22ND, VIRTUAL, STILL POSSIBLE TO SIGN UP AND I STRESS HERE, SOME OF THE CHALLENGES WE SEE WITH INDIVIDUALS WITH HIV AIDS CO-MORBIDITIES, A REAL INTERSECTION I THINK OF SOCIAL INFRASTRUCTURAL NEEDS. SO EMPHASIZE PEOPLE HAVING IN MIND THAT CONNECTION AND CONSIDERING WHETHER THEY WANT TO SPEND TIME AT THIS SUMMIT AND LEARNING THE WAY IT INTERSECTS WITH SOME OF THE OTHER BROADER CATEGORIES OF CARE SERVICES FOR OLDER ADULTS VERY MUCH INCLUDING THOSE WITH HIV. NEXT PLEASE. TALK ABOUT GERO SCIENCE A BIT, I WON'T GO INTO IT AGAIN BUT TO SAY THE FOURTH GERO SCIENCE SUMMIT OCCURS THIS ONE HYBRID HOPEFULLY BY APRIL WILL BE ALL RIGHT ON CAMPUS. OPEN FOR REGISTRATION NOW. THIS WILL DEAL WITH THE MANY ASPECTS OF BASIC BIOLOGY OF AND SOCIAL DETERMINANTS OF AGING HOW THEY INTERSECT WITH CONDITIONS OF THE DISEASE RELEVANT TO HIV AMONG OTHERS. FINALLY FROM MY PRESENTATION TODAY A SERIES OF WAYS WHICH WE HOPE WE CAN KEEP IN TOUCH WITH YOU AND WHAT WE ARE DOING BEING PROACTIVE SUBSCRIBING TO OUR BLOG OR SUBSCRIBING TO ANY ONLINE SERVICES. WE TREASURE THE INPUT FROM ALL OF YOU IN YOUR COMMUNITY AND HOPE THIS WILL CONTINUE. LET ME STOP THERE AND SEE WHAT WORKS ON YOUR AGENDA AND MORE TALK ABOUT MAKING CLEAR OTHER FOLKS AT NIA WILL BE TALKING WITH YOU IN THE TIME TO COME DURING THIS MEETING. MARINE, WHERE ARE WE? WHAT CAN I DO FOR YOU? >>I WANT TO THANK YOU FOR A GREAT PRESENTATION. IF YOU HAVE A MINUTE OR TWO FOR COUPLE OF QUESTIONS OR -- I KNOW YOU DO HAVE TO LEAVE. I SEE THAT (INAUDIBLE) FROM CDC HAS A QUESTION. IS THAT OKAY? >>ABSOLUTELY. >>GREAT. >>THANK YOU VERY MUCH FOR A TOUR DE FORCE, INCREDIBLE WORK. YOU HIGHLIGHTED NUMBER OF AREAS FOR RESEARCH FROM LIKE DISEASES THAT PREDOMINANTLY OCCUR IN OLDER AGE AND THEN SOME OF THE ASPECTS OF AGING AMONG PEOPLE WITH HIV. I HAD A QUESTION FOR YOU PERSONALLY. WHICH IS FROM THE FUNDAMENTAL CELLULAR ASPECTS OF AGING WHETHER GLYCOSYLATIONS TO FORMIZATION, TELOME LINK, -- PHOSPHORYLATION, WHATEVER, THERE'S A MOVEMENT OF SCIENCE INTO CLINICAL TRIALS. I WAS JUST WONDERING, DO YOU HAVE ANY SENSE OF WHAT YOU THINK WOULD BE THE MOST PROMISING INTERVENTIONAL CLINICAL TRIALS THAT COULD BENEFIT PEOPLE WITH HIV AT THIS TIME? ARE THERE ANY THAT ARE INCLUDING PEOPLE WITH HIV? >>GREAT QUESTION. STARTING WITH THE BASIC, IT IS THE QUESTION WHETHER THERE WERE TREATMENTS FOR INTERVENTION NOT FOR A SPECIFIC DISEASE OR CONDITION RELATED TO AGING BUT COULD INTERVENE SOMEHOW IN AGING PROCESSES THAT ARE RELEVANT TO MULTIPLE CONDITIONS DISEASES MAKE A DIFFERENCE, THERE'S BEEN A LONG STANDING ONE. THE INTERVENTION AROUND THE LONGEST SURE YOU ARE AWARE, IS CALORIC RESTRICTION. AND WHAT ITS PRACTICALITIES WERE BUT MORE RECENTLY THERE'S SOME -- THIS IS SOME VERY IMPRESSIVE PROGRESS, IN AREAS AROUND THE PILLARS MECHANISMS OF AGING ONE WHICH I COULD FOCUS ON MAYBE TO YOUR QUESTION, SPECIFICALLY IS THAT OF SENESCENCE. CELLULAR SENESCENCE. JUST TO BRING PEOPLE UP TO COMMON BASES FOR THIS, THIS IS DESCRIBED AS A PHENOMENON WHICH SAYS IF YOU CULTURE CELLS IN VITRO, IN TISSUE CULTURE THEY SINs AND STOP DIVIDING. THAT WAS BIG NEWS IN 19 # 0s BECAUSE UNTIL THEN THE LANGUAGE WAS INDIVIDUAL CELLS WERE IMMORTAL. NOW AS A RESULT OF CELLULAR SENESCENCE AND CHARACTERIZING WHAT IT MEANS FOR THEM TO SINESCE IN THE PAST DECADE QUITE EXTRAORDINARY PROGRESS IDENTIFYING NORMAL ANIMALS AN INDIVIDUALS AS THEY AGE, SENESCENCE CELLS APPEAR, CAN BE IDENTIFIED BY GENE EXPRESSION PATTERNS WHAT THEY SECRETE, THEY INCREASE NUMBERS WITH AGING, THEY ARE IN ALL TISSUES. AND THEY DON'T JUST SIT THERE CELLS THAT CAN'T DIVIDE ANY MORE, BECAUSE OF THE SECRETORY PHENOTYPES HAVE ADVERSE EFFECTS IN MANY DOMAINS ANDY MENTIONS. IN ANIMAL STUDIES OVER THE PAST FEW YEARS DRAMATIC FINDINGS WENT THROUGH CLEVER GENETIC MANIPULATIONS, SENESCENCE CELLS WERE SELECTIVELY ELIMINATED. FUNCTION, MOTOR FUNCTION, COGNITIVE FUNCTION LIFE SPAN ALL INCREASE. TO YOUR POINT ABOUT CLINICAL TRANSLATION AFTER THIS -- APOLOGIZE FOR THE LONG BUILD UP TO IT. NOW QUITE REMARKABLY THIS IS INTO CLINICAL TRIALS PRIVATE SECTOR IS TAKEN UP LOOKING AT DRUGS THAT HAVE RELATIVELY SELECTIVE IMPACTS ON SENESCENCE CELLS. IN THE BEGINNING AS MAKES NO SENSE TRANSLATION NOT TRYING TO IF YOU WILL CURE AGE OR EXTEND LIFE SPAN BUT FIRST LOOKING AT SPECIFIC CONDITIONS, AND THEY INVOLVE SKIN CONDITIONS, MUSCULOSKELETAL CONDITIONS, WHERE SENESCENCE CELLS ACCUMULATIONS HAPPEN, EASY TO MONITOR WHEN SENESCENCE CELLS ARE AFFECTED BY TREATMENT. A QUITE EXTRAORDINARY PACE, THIS IS MOVING INTO CLINICAL AREAS. I THINK WE ARE NOT QUITE THERE YET. TO MY KNOWLEDGE AT LEAST FOR HIV INFECTION. BUT EXTENT WE ARE LOOKING AT IMPACTS ON THE IMMUNE SYSTEM AND ELIMINATING SENESCENCE CELLS BY TRANSCRIPTIONAL FACTOR MANIPULATIONS, YOU MENTION SPECIFIC LIP REVERSING CHANGES OF AGING AND ENHANCING RESPONSIVENESS OF THE SYSTEM, ONE CAN IMAGINE HERE IMPACT ON ERADICATING INFECTION INCLUDING CHRONIC INFECTION. THAT IS PROBABLY TRAJECTORY THAT MAKES MOST SENSE TO ME AS ONE RELEVANT TO HIV AT PRESENT. SO THE PACE EARLY STAGES BUT QUITE EXTRAORDINARY AS A RATE OF DEVELOPMENT I WOULD THINK. >>GREAT. ARE THERE ANY -- I DON'T SEE ANY OTHER HANDS BUT IF YOU HAVE TIME FOR ONE MORE QUESTION IF THERE IS ONE. >>HAPPY TO. >>BLANTON, CAN YOU SEE ANYTHING THAT I'M MISSING? >>I DON'T SEE HANDS. ACTUALLY DR. BRANDEAU. >>THANK YOU FOR THE GREAT PRESENTATIONS, SUPER INTERESTING. MY QUESTION, I THOUGHT YOUR WHAT YOU TALKED ABOUT WITH THE SESSIONS FOR INVESTIGATORS NEW TO THE FIELD REALLY EXCITING. AND YOUR BUSINESS DEVELOPMENT STARTUP IDEAS OR WHATEVER YOU WANT TO CALL THAT.MENT I WONDER IF OTHER PARTS OF NIH ARE DOING SUCH THINGS? THEY SEEM LIKE REALLY WONDERFUL WAYS OF WE HAVE TALKED ABOUT A LOT OF SCHOLARS, DON'T STAY IN ACADEMIA FOR BETTER OR WORSE. OR DON'T DO BAYING IS RESEARCH. . THEY JUST SEEM LIKE WONDERFUL WAYS TO ENGAGE PEOPLE, WONDER IF OTHER PARTS OF NIH ARE DOING SIMILAR THINGS. >>I DO THINK IT IS RELATIVELY NOW, SO WE FIRST INSTITUTED THE PROGRAM, PRESENTED IT AT ONE OF OUR THURSDAY MORNING MEETINGS INSTITUTE DIRECTORS, WELL RECEIVED WITH INTEREST SO WE TALKED TO OTHER INSTITUTES BUT SO NEW THERE'S NOT TIME FOR IT TO BE PICKED UP AS YET. THAT SPECIFIC PROGRAMMING. >>THANK YOU SO MUCH AGAIN RICHARD, GOOD TO SEE YOU, GOOD LUCK WITH YOUR NEXT MEETING. >>MY PLEASURE. >>TAKE IT. BYE-BYE. BLANTON, BACK TO YOU. >>THANK YOU, MAUREEN. SO WE HAVE TWO ADDITIONAL SPEAKERS IN THIS SESSION AND CERTAINLY GOING TO HAVE A RICH DISCUSSION AFTERWARDS. SO I WANT TO NOW INTRODUCE DR. STACY LAWRENCE, THE NIA DIVISION OF AGING AND BIOLOGY AND DR. BASAL ELDAHDAH DIVISION OF GERIATRIC AND CLINICAL GERONTOLOGY. WELCOME, COLLEAGUES. >>THANK YOU. I WANT TO THANK DR. HODES FOR COMPREHENSIVE OVERVIEW OF NIA AND INTRODUCING OUR HIV RESEARCH THAT WE SUPPORT. BAS AL WILL AND I WILL PROVIDE ADDITIONAL FOCUS ON THE CIVIC DIVISIONS DR. HODES MENTIONED. ALSO RECENT HIGHLIGHTS FROM HIV STUDIES SUPPORTED BY NIA. TO INTRODUCE THE NIH AVE TEAM. IN I A DIVISION TO MYSELF AND BASIL, THE TEAM ALSO INCLUDES DR.S MELISSA GERALD, MACKOITH (PHONETIC) AND MIA MACK, AND THEY SHOULD BE AVAILABLE AT THE CONCLUSION OF THE PRESENTATION TO ANSWER QUESTIONS. AS DR. HODES MENTIONED THERE ARE FOUR SCIENTIFIC DIVISIONS AND I WILL START WITH THE DIVISION OF AGING BIOLOGY. WHICH IS DIVISION I REPRESENT IN THE WORK GROUP AT NIA. THIS DIVISION HAS A FOCUS ON UNDERSTANDING THE IMPACT OF HIV INFECTION AND PATHOGENESIS, IN THE CONTEXT OF AGING RELATED GENETIC MOLECULAR AND CELLULAR CHANGES. AS WELL AS PHYSIOLOGICAL OUTCOMES. WE SUPPORT RESEARCH TO UNDERSTAND THE MOLECULAR MECHANISMS THAT MAY BE COMMON TO MULTIPLE CO-MORBID STATES IN AGING. INCLUDING AGING WITH HIV. AND WE ALSO PROVIDE RESEARCH RESOURCES TO ADVANCE THESE AND OTHER AGING STUDIES. NEXT SLIDE. MANY OF THE STUDIES SUPPORT AIMING TO UNDERSTAND THE INTERACTIONS AMONG THE HALLMARKS OF AGING, AS WELL AS MECHANISMS INVOLVED IN IMPORTANT CROSS TALK. DR. HODES MENTIONED A LITTLE BIT ABOUT THE HALLMARKS OF AGING, WHICH ARE BIOCHEMICAL CHANGES THAT OCCUR IN ALL ORGANISMS THAT EXPERIENCE BIOLOGICAL AGING AND LEAD TO PROGRESSIVE LOSS OF OR I GUESS DEFICITS LEAD TO PROGRESSIVE LOSS OF PHYSIOLOGICAL INTEGRITY IMPAIRED FUNCTION LEADING TO FRAILTY AN CO-MORBIDITIES ASSOCIATED WITH AGING. THESE CHANGES INCLUDE DYSFUNCTION, CELLULAR SENESCENCE WE HAD A CONVERSATION ABOUT. MITOCHONDRIAL DYSFUNCTION, MICROBIOME DYSBIOSIS, LOSS OF PROTEIN INTEGRITY, EPIGENETIC CHANGES AMONG MANY OTHERS. THE DIVISION ALSO SUPPORTS RESEARCH EXAMINATIONS SIGNALING PATHWAYS AND MECHANISMS INVOLVED IN INTERORGAN COMMUNICATION, WHICH AS SOME OF YOU MAY KNOW IS THE GATEKEEPER FOR METABOLIC HEALTH THESE MULTI-DIRECTIONAL INTERACTIONS BETWEEN THE VARIOUS ORGANS ALONG WITH THE CENTRAL NERVOUS SYSTEM HELPED MAINTAIN WHOLE BODY HOMEOSTASIS AND ENSURES SORT OF OUR ABILITY TO ADAPT TO OUR ENVIRONMENT. HIV INFECTION HAS BEEN SHOWN TO IMPACT SEVERAL OF THESE PROCESSES AND MANY HIV STUDIES WITHIN OUR DIVISION PORTFOLIO ARE FOCUSED ON THESE AREAS. AS DR. HODES MENTIONED OUR DIVISION IS ALSO LEADING EFFORTS ON GERO SCIENCE WHICH IS FOCUSED ON DISCOVERY AN TRANSLATION OF BIOLOGICAL TARGETS TO INTERVENTIONS THAT PREVENT MINIMIZE OR REVERSE AGING RELATED DEFICITS. THESE DEFICITS ARE WHAT DIMINISHED QUALITY OF LIFE FOR OLDER INDIVIDUALS. OUR DIVISION SUPPORTS TWO SPECIFIC PROGRAMS THAT LOOK AT PRE-CLINICAL RESEARCH TO IDENTIFY INTERVENTIONS THAT IMPACT NOT JUST LONGEVITY BUT HEALTH SPAN. AND AGAIN WE WILL BE HOLDING THE FOURTH GERO SCIENCE SUMMIT, WILL TAKE PLACE NEXT MONTH, INCLUDES PRESENTATIONS OF RELEVANCE TO THE HIV COMMUNITY. AND IF YOU WOULD LIKE ADDITIONAL INFORMATION ABOUT GERO SCIENCE MORE BROADLY OR SUMMIT FIND ON OUR DIVISION OF AGING WEBSITE. LASTLY, FOR THE DIVISION OF AGING BIOLOGY, I WANT TO HIGHLIGHT A COUPLE OF RECENT STUDIES THAT PROVIDE COMPELLING EVIDENCE HIV INFECTION CAUSES ACCELERATED AGING. TWO GROUPS THAT HAVE SHOWN USING VARIOUS EPIGENETIC PLAQUES WHICH MEASURE GENERAL IF I CAN MODIFICATIONS OR METHYLATION CHANGES TO THE GENOME, THAT HAVE BEEN ASSOCIATED WITH CELLULAR AGING, OCCUR FROM THE VERY BEGINNING OF HIV INFECTION AS A STRESSOR AND SHOWS ABOUT A TWO TO FIVE YEAR ACCELERATION IN BIOLOGICAL AGE. THESE STUDIES WERE PERFORMED AT A SMALL NUMBER OF PARTICIPANTS SO MORE WORK NEEDS TO BE DONE IN THIS AREA TO UNDERSTAND DURATION OF THIS ACCELERATION WHETHER ACCELERATION AGING FLUCTUATES OVER TIME. AND WITH EFFECTIVE INTERVERTEBRAL TREATMENT. MORE RESEARCH NEEDS TO BE DONE TO LINK STUDIES TO MORBIDITY AND MORTALITY IN PEOPLE WITH HIV. SO THE DIVISION OF NEUROSCIENCE IS REPRESENTED BY DR.S MACKOWITSTS WITH OUR TEAM AT NIAND THAT FOCUSES ON FURTHERING ARE THE UNDERSTANDING OF NOT ONLY DEMENTIA AND AGE AND THE NEUROLOGICAL PROCESSES ASSOCIATED WITH A NORMALLY AGING BRAIN. THIS DIVISION SUPPORTS BASIC CLINICAL EPIDEMIOLOGICAL STUDIES OF ALZHEIMER'S DISEASE ON RELATED DEMENTIA AGING AS WELL AS RELATIONSHIPS BETWEEN HIV INFECTION AND COGNITIVE DECLINE ESPECIALLY IN ALZHEIMER'S DISEASE AND OTHER NEUROLOGICAL IMPAIRMENTS IN PEOPLE WITH HIV AND ADVANCING AGE. SO THE DIVISION OF NEUROSCIENCE PORTFOLIO INCLUDE SEVERAL STUDIES, INCLUDING THESE THAT ARE LISTED HERE FROM COLLABORATION BETWEEN THE NIA AND OAR THAT WAS INITIATED IN I THINK 2018, 2019, TO ASSESS SIMILARITIES AND DIFFERENCES IN HIV ASSOCIATED NEUROLOGICAL COMPLICATIONS IN ALZHEIMER'S DISEASE. SIX STUDIES SUPPORTED THROUGH THIS PARTNERSHIP, WITH YEARLY PROGRESS UPDATES, AS WELL AS OPPORTUNITIES AMONG THE AWARDED RESEARCHERS OR COLLABORATION AND NETWORKING. THERE HAVE BEEN SEVERAL IMPORTANT DISCOVERIES MADE ALREADY FROM THESE INVESTIGATORS. AND I WILL JUST HIGHLIGHT ONE OF THE STUDIES LED BY DR.S SUSAN AND JOHN QUERY FROM THE SCHOOL OF MEDICINE MOUNT SINAI. NEXT SLIDE PLEASE. SO ON THIS STUDY DR.S MORBELA FOUND HIV DURATION BUT NOT ACTIVE BRAIN INFECTION PREDICTS CRITICAL CORTICAL DATA DEPOSITION. ABNORMAL DEPOSITION OF THE ANTIMICROBIAL PEPTIDE AMYLOID BETA, IS CHARACTERISTIC OF ALZHEIMER'S DISEASE. SO THE OBJECTIVE OF THIS STUDY WAS TO ELUCIDATE RISK FACTORS FOR BRAIN AMYLOID BETA IN A COHORT THAT WAS ENRICHED FOR HIV AND OTHER NEUROTROPIC AGENTS. IN THE FIGURE YOU CAN SEE PATTERNS OF AMYLOID BETA DEPOSITION IN THE BRAIN OF HIV HIV PATIENTS AND TS STUDY SHOWED HIV STATUS IS PROTECTIVE FOR AMYLOID, IN SHORT NO INCREASED EVIDENCE OF AMYLOID BETA IN HIV, OR GREATER HIV DISEASE DURATION AS RISK FOR AMYLOID DEPOSITION. THIS REPLACES CHRONOLOGICAL AGE AS A RISK FACTOR. FINALLY, PTAU IN NEURONS, NOT CORTICAL AMYLOID BETA DEPOSITION, IS ASSOCIATED WITH DECREASED GLOBAL COGNITIVE SCORE. MORE INFORMATION CAN BE FOUND ON THE DIVISION OF NEUROSCIENCES WEBSITE. I THINK WITH THAT I WILL TURN IT OVER TO BASIL. >>THANK YOU, STACY. IF WE COULD HAVE THE NEXT SLIDE PLEASE.LY TALK ABOUT OTHER TWO DIVISIONS, DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY, SUPPORTS CLINICAL TRANSLATIONAL RESEARCH ON HEALTH AND DISEASE AND THE AGENT AS WELL AS RESEARCH IN AGING OVER THE HUMAN LIFE SPAN INCLUDING RELATIONSHIPS TO HEALTH OUTCOMES. AS DR. HODES PRESENTED HIS TALK, THE BULLET THAT MAPS TO OUR DIVISIONS INTEREST RELATE TO HIV IS THIS ONE, ENHANCING ASSESSMENT AND TREATMENT OF OLDER INDIVIDUALS WITH HIV AND CO-MORBIDITIES POLYPHARMACY, DISABILITY OR DISPARITIES IN HEALTH OUT. COOUTCOMES.SO THERE ARE TWO FRAS THAT DESCRIBE AN INDIVIDUAL WITH MULTIPLE CHRONIC CONDITIONS, THE CO-MORBIDITY MODEL, FOCUSES ON INDEX CONDITION, AT THE CENTER OF AN INDIVIDUAL'S EXPERIENCE, CO-OCCURRING WITH SEVERAL OTHER CO-MORBIDITIES BUT IN CLINICAL AGING RESEARCH, THERE'S A FRAMEWORK BASED ON THE IDEA OF MULTI-MORBIDITY. AND THIS DISTINCTION IS IMPORTANT FOR A FEW DIFFERENT REASONS. ONE IS THAT IT RECOGNIZES THAT PEOPLE MAY HAVE MORE THAN JUST DIAGNOSED CO-OCCURRING DISEASES, THEY MAY ALSO HAVE CONDITIONS AND SYNDROMES LIKE DISABILITY OF RECURRENT FALLS, HEARING OR VISUAL IMPAIRMENT, SARCOPENIA, MANY OTHERS. ALSO TO EFFECTIVELY MANAGE MULTIPLE CONCURRENT DISEASES AND CONDITIONS, THERE NEEDS TO BE A SHIFT FROM TREATING EACH ONE INDIVIDUALLY TO UNDERSTANDING HOW ALL THE CONDITIONS INTERACT WITH EACH OTHER, THE TRADE-OFFS THAT NEED TO BE CONSIDERED IN DOING SO, AND HOW INDIVIDUALS INTERACT WITH THE HEALTHCARE SYSTEM AS A RESULT. THEN THIRDLY, MULTI-MORBIDITY MODEL PLACES THE FOCUS BACK ON THE PATIENT, THE INDIVIDUAL WHO IS AT THE CENTER OF THIS. AND WHO IS MORE THAN JUST THE SUM OF THEIR DISEASES AND THEIR CONDITIONS, BUT SOMEONE WHO EXISTS IN A SOCIAL CULTURAL AND ENVIRONMENTAL MILIEU. NEXT SLIDE PLEASE. SO THIS IS AN EXAMPLE OF ONE OF THE MANY STUDIES THAT WE ARE CURRENTLY SUPPORTING, THIS IS FROM DR. EMILY HYLE INFECTIOUS DISEASE SPECIALIST AT MASS GENERAL HOSPITAL AND HARVARD MEDICAL SCHOOL. HER AND HER TIME DEVELOPED A MICROSIMULATION MODEL OF MULTI-MORBIDITY FOR PEOPLE AGING WITH HIV. BY POPULATING THIS MODEL WITH PUBLISHED DATA FROM COHORT AND FROM CLINICAL TRIALS, THEY CAN PROJECT LONG TERM CLINICAL OUTCOMES AND COSTS FOR PEOPLE AGING WITH HIV IN THE US. HEADACHE ALSO COMPARE CROSS EFFECTIVENESS FOR DIFFERENT STRATEGIES FOR INTERVENTION DIAGNOSESSIS AN TREATMENT OF SEVERAL CURRENT CONDITIONS INCLUDING ONES NOTED HERE, DEPRESSION, DEMENTIA, CARDS OWE VASCULAR DISEASE AND HIV. -- CARDIOVASCULAR DISEASE AN HIV. ON THE RIGHT HAND SIDE YOU CAN SEE SAMPLE MODEL OUTCOMES FOR CUMULATIVE INCIDENCE OF DEMENTIA, OVER THE NEXT 35 YEARS AMONG PEOPLE IDENTIFIED AS ANNOUNCED AT BIRTH. FIGURE ALSO INCLUDES SENSITIVITY ANALYSES BASED ON MODEL TWOFOLD, INCREASE IN DEMENTIA INCIDENCE AMONG PEOPLE WITH HIV WHICH IS THE ORANGE LINE. OR AMONG PEOPLE WITH HIV FULLY ENGAGED IN HIV CARE WHICH IS THE BLUE LINE. SO THE IDEA BEHIND THE STUDY TO UNDERSTAND HOW MULTIPLE CHRONIC CONDITIONS CONVERGE IN INDIVIDUALS, HOW THEY LEAD TO ADDITIVE EFFECTS HOW THERE MAYBE COMPETING RISKS FOR VARIOUS OUTCOMES AND HOW THEY INFECT -- HAVE AN EFFECT ON CARE AND COST. I WANT TO HIGHLIGHT ONE NI ASHES PROGRAM THE GEM STAR PROGRAM, A PRE-K PROGRAM FOR EARLY CAREER PHYSICIANS OR DENTISTS INTERESTED IN RESEARCH CAREER THAT BRIDGES THEIR CLINICAL SPECIALTY WITH AGING RESEARCH. IT PROVIDES TWO YEARS OF RESEARCH SUPPORT AND AWARDEES ARE ALSO EXPECTED TO SECURE SOME INDEPENDENTLY SUPPORTED PROFESSIONAL DEVELOPMENT. WILL IS ALSO A YEARLY INVESTIGATORS MEETING FOR NETWORKING AND ADDITIONAL MENTORING. IT IS VERY WELL SUBSCRIBED PROGRAM, VERY COMPETITIVE, SINCE WE STARTED THE PROGRAM IN 2011, THERE'S BEEN EIGHT GEMSSTAR AWARDEES FOCUSING ON HIV AND AGING RESEARCH PROJECTS AND YOU MAY RECOGNIZE MANY NAMES HERE, MOSTLY THEY ARE INDIVIDUAL WHOSE HAVE INFECTIOUS DISEASE SPECIALTY TRAINING, AND WE ARE NOW SEEING THAT THE EARLIER AWARDEES OF THIS PROGRAM ARE GOING ON TO COMPETE SUCCESSFULLY FOR RO1s AND K AWARDS, AND TAKING LEADERSHIP POSITIONS IN THEIR INSTITUTIONS AS WELL AS IN OTHER PROFESSIONAL SOCIETIES. VERY SUCCESSFUL PROGRAM. SO I WILL PRESENT THE NEXT FEW SLIDES ON BEHALF OF MY COLLEAGUE, DR. MELISSA GERALD IN OUR DIVISION OF BEHAVIORAL SOCIAL RESEARCH, THIS DIVISION SUPPORTS SOCIAL BEHAVIORAL PSYCHOLOGICAL AND ECONOMIC RESEARCH AND RESEARCH TRAINING ON THE PROCESSES OF AGING OF BOTH THE INDIVIDUAL AND SOCIETAL LEVELS. THE TUITION SUPPORTS BASIC RESEARCH, THAT DOWN THE ROAD CAN HAVE IMPLICATIONS FOR HEALTH AND INTERVENTION RESEARCH AIMED AT IMPROVING PHYSICAL HEALTH OR PSYCHOLOGICAL HEALTH AND WELL BEING OR BOTH. NEXT SLIDE PLEASE. AS THE WORD CLOUD SHOWS HERE NIA IS FUNDING HIV AIDS RESEARCH FOCUS ON BROAD RANGE OF TOPIC AREAS. NEXT SLIDE. AND AS EXAMPLE OF SPECIFIC RESEARCH SUPPORTED BY THIS DIVISION, THIS IS ONE, NEWLY FUNDED RO1 FROM DR. J,SUS, CHIEF OF DIVISION OF PREVENGES SCIENCE AND HIV AIDS SCIENCE OF THE AIDS RESEARCH INSTITUTE AT UCSF. SO THE PREMISE FOR THE STUDY IS WHILE THERE IS SOME EVIDENCE SUGGESTING SEXUAL HEALTH IN GAY MEN IS NEGATIVELY AFFECTED BY STIGMA BASED ON HOMOSEXUALITY, RACE AGE AN HIV STATUS, DR HIS PROJECT WHETHER WHEN THESE FACTORS COMBINED AFFECTED HEALTH IN OLDER GAY MEN SO RACIAL HOMOSEXUAL AND HIV STATUS, STRUCTURAL RACISM AND DISCRIMINATION RESOURCES AN BIOMARKERS OF HEALTH AGING IN GAY MEN, IN FOUR RACIAL ETHNIC GROUPS. AFRICAN AMERICAN, LATINX, ASIAN AMERICAN AND WHITE. AN ACROSS HIV STATUS. THE TEAM IS GUIDED BY SEVERAL THEORIES STRESSED ACROSS THAT SOCIAL INTEGRATION STIGMA AND THEY HYPOTHESIZE THAT SEXUAL AND ETHNIC RACIAL MINORITIES ARE EXPOSED TO STRESSORS IN THE FORM OF STRUCTURAL RACISM, DISCRIMINATION AND STIGMA. AND THAT EXPERIENCING STIGMA THROUGH THE ACTIONS OF OVERS CAN LEAD TO INCORPORATION OF SOCIETAL AND WHAT IS CONCEPT OF SELF ALSO CALLED INTERNALIZED STIGMA WHICH MAY LEAD TO SIGNIFICANT HEALTH INEQUITIES THROUGH PHYSIOLOGICAL EFFECTS AND INTERNALIZATION. SO NEXT SLIDE PLEASE. SO THANKS FOR YOUR ATTENTION. THAT IS JUST A SNAP SHOT OF WHAT WE DO AT NIA. THERE IS PLENTY MORE TO TALK ABOUT BUT GIVEN THE TIME I WILL HAND IT OVER TO DR. BANSAL NOW. >>ALL RIGHT. THANK YOU, DR. LAWRENCE AND ELDAHDAH FOR THE TWO PRESENTATIONS. IF YOU COULD PLEASE MAYBE STOP SHARING YOUR SLIDES FOR THE MOMENT. I WOULD LIKE TO ENTER DEUCE OUR NEXT PRESENTER. SO NEXT ON THE AGENDA IS DR. GEETANJALI BANSAL. SO DR. BANSAL IS A SENIOR SCIENCE OFFICER AT THE OAR. SHE LEADS THE OAR HIV AND AGING SIGNATURE PROGRAM AND PARTICIPATE IN THE OAR EARLY CAREER INVESTIGATORS HIV PROGRAM WITH SHARED RESPONSIBILITY FOR CROSS CUTTING AREAS OF RESEARCH INCLUDING HIV ASSOCIATED CO-MORBIDITIES, CO-INFECTIONS AND COMPLICATIONS. SO IN THE SECOND TIME I WANT TO HAND THIS OVER -- IN THE SAKE OF TIME I WILL HAND IT TO DR. BANSAL TO WRAP UP THE PRESENTATIONS IN THIS SESSION. >>THANK YOU, DR. TOLBERT. THANK YOU, DR. ELDAHDAH AND DR. CARRINGTON-LAWRENCE. I'M GOING TO PROVIDE AN OVERVIEW OF THE NIH OAR HIV AND AGING PORTFOLIO AND THE BRIEFLY THE SIGNATURE -- AGING SIGNATURE PROGRAM. NEXT SLIDE PLEASE. WITH THE SUCCESS OF ANTI-RETROVIRAL THERAPIES PEOPLE WITH HIV ARE LIVING LONGER AND NOW CAN HAVE NEARLY NORMAL LIFE SPAN WITH APPROPRIATE TREATMENT. MORE THAN HALF OF THE PEOPLE WITH HIV IN THE UNITED STATES ARE 50 YEARS OR OLDER. THIS AGE GROUP IS STEADILY INCREASING, VERSUS THE STABLE NUMBERS IN THE YOUNGER AGE GROUPS. NEXT SLIDE PLEASE. IN 2020, 17% OF DIAGNOSIS OF HIV INFECTION IN THE U.S. WERE AMONG PEOPLE AGE 50 OR OLDER. 43% IN 30 TO 49 YEARS AGE GROUP AND 40% IN THE YOUNGER POPULATION. THE PROCESS OF AGING IS ACROSS THE LIFE SPAN. IN FACT EPIGENETIC CHANGES HAVE BEEN SEEN IN THE YOUNG PEOPLE THAT ARE NEARLY INFECT WITH HIV AND ON ANTI-RETROVIRALS. WE HAVE HEARD FROM THE OLDER COMMUNITY REP RECENTLY ABOUT THEIR NEEDS AN CHALLENGES THEY ARE FACING AND BEING RESPONSIVE TO THAT, THE FOCUS OF THIS PRESENTATION IS ON THE OLDER AND OF THE AGING SPECTRUM. NEXT SLIDE PLEASE. OLDER ADULTS WITH HIV FACE THE SAME ISSUES AS THEIR PEERS WITHOUT HIV AS WELL AS SOME UNIQUE CHALLENGES. THEY ARE MORE LIKELY THAN THE PEERS WITHOUT HIV TO EXPERIENCE CERTAIN AGE RELATED COMPLICATIONS, MOST COMMON CO-MORBIDITIES BEING NEUROCOGNITIVE IMPAIRMENT, MUSCLE DISORDERS, FRAILTY, CARDIOVASCULAR DISEASE, MAKING POLYPHARMACY AND DRUG DRUG INTERACTIONS MAJOR ISSUES. ON SOCIAL BEHAVIORAL SIDE PEOPLE AGING WITH HIV FACE MULTIPLE INTERSECTIONAL STIGMAS, FOR EXAMPLE, HIV AND AGEISM, SOCIAL ISOLATION, INCREASE CAREGIVER BURDEN AND OTHER MENTAL CO-MORBIDITIES FOUND IN THE INTERSECTION OF AGING AND HIV. THIS AGE GROUP HAS MORE COMPLEX CARE AND SUPPORT SERVICE NEEDS DUE TO THESE DISTINCTIVE CHALLENGES. NEXT SLIDE PLEASE. AGING WITH HIV HAS MULTIPLE FACETS. AND REQUIRES A MULTI-DIMENSIONAL RESPONSE. THIS IS REFLECTED BY THE CURRENT HIV AND AGING PORTFOLIO THAT IS SUPPORTED BY 17 OF THE 27 NIH INSTITUTES CENTERS AND OFFICES. THE TOTAL NIH INVESTMENT IN HIV AND AGING RESEARCH FOR FY 22 IS $119 MILLION, ABOUT 5% OF THE TOTAL HIV FUNDS. OVERALL, RESEARCH ON HIV AND AGING WOULD BENEFIT FROM GROWTH. WHAT I AM SHOWING HERE THE PAST FIVE YEARS, HAVE INCREASED FUNDING FOR HIV AND AGING RESEARCH BY 50% OR MORE. NEXT SLIDE PLEASE. THE PORTFOLIO INCLUDES RESEARCH FUNDED THROUGH A VARIETY OF FUNDING MECHANISMS THE LARGEST IS THE RO1, MAJORITY OF THESE GRANTS ARE UNSOLICITED. THE RO1s ARE FOLLOWED CLOSELY BY COOPERATIVE AGREEMENTS, MAJORITY OF WHICH ARE COMPOSED OF HIV COHORTS SUCH AS MAX WISE. THE REST INCLUDE CFARS, THE TISSUE CONSORTIUM OR REPOSITORIES AND OTHER TYPES OF GENETIC APPLICATIONS. NEXT SLIDE PLEASE RESEARCH IN HIV AND AGING PORTFOLIO FALLS UNDER ALL THE HIV RESEARCH PRIORITIES MAJORITY BEING IN CROSS CUTTING RESEARCH AND ADDRESS THERAPIES FOR HIV ASSOCIATED CO-MORBIDITIES AND CO-INFECTIONS. CROSS CUTTING RESECTION INCLUDES BASIC AS WELL AS BEHAVIORAL AND SOCIAL SCIENCES RESEARCH, TRAINING AMONG OTHERS. THE NIH HIV PROGRAM ALSO SUPPORTS RESEARCH ON THE DEVELOPMENT OF EVIDENCE BASED STRATEGIES AND EVALUATING STRATEGIES FOR RISK MANAGEMENT OF CO-MORBIDITIES AND EVALUATING AND REFINING INTEGRATED CARE PREVENTIONS INTERVENTIONS FOR PEOPLE WITH HIV. SEVERAL EXAMPLES ARE SHOWN BY THE COLLEAGUES EARLIER TOO. THESE GENERALLY COME UNDER NEXT GENERATION THERAPIES. SOME OF THESE PROGRAMS ALSO HELP EXPAND CLINICIANS CROSS TRAINED IN HIV AND OTHER RELEVANT DISCIPLINES. THIS SLIDE SHOWS THE MAJOR TOPIC AREAS COVERED BY THE PROJECTS IN THE HIV AND AGING RESEARCH PORTFOLIO. VIEW PORTFOLIO ANALYSIS PLATFORM THAT USES TEXT MINING FOR ANALYSIS AND RATES ACROSS PROJECTS OF SIMILAR TOPICS. THE LISTED TOPICS ARE MAJOR TEAMS ON AREAS WE SAW RATHER THAN COMPREHENSIVE LISTING OF ALL THE TOPICS IN THE PEAK. SO THIS SLIDE HIGHLIGHTS THE BREATH AND DEPTH OF THE HIV AND AGING RESEARCH PORTFOLIO THAT ENCOMPASSES CO-MORBIDITIES AND COMPLICATIONS PREVENTION, TREATMENT, CARE SERVICES, AS WELL AS THE NEXT GENERATION OF HIV RESEARCH CENTERS. NEXT SLIDE PLEASE. CURRENTLY THERE ARE TWO ACTIVE FOAs TO US CANNED ON HIV AND AGING, THESE ARE LONG STANDING FUNDING OPPORTUNITIES WITH -- SINCE 2012, CURRENTLY 7 ICs ARE PARTICIPATING IN IT. AND THERE'S CERTAINLY IS ROOM FOR MORE. NEXT SLIDE PLEASE. SO THIS IS DR. GOODENOW ALREADY COVERED THIS SO BRIEFLY BASED ON THE PORTFOLIO ANALYSIS AND INPUT FROM VARIOUS PERSPECTIVES AND COMMUNITY VOICES, NIH OAR INSTITUTED SIGNATURE PROGRAM ON HIV AND AGING. AND AIMS TO CATALYZE COLLABORATIONS TO ADDRESS RESEARCH AT INTERSECTION OF HIV AND AGING. NEXT SLIDE PLEASE. TO FURTHER GOALS OF CATALYZING THIS RESEARCH AND EXPANDING THE POOL OF HIV AND AGING RESEARCHERS, OAR PARTNERED WITH NIA AND TO FUND SUPPLEMENTS AND WE DID THAT IN THE LAST FISCAL YEAR. WE HAD A ROBUST RESPONSE INCLUDING 17 AWARDS INCLUDING NON-HIV AND HIV PARENT GRANTS PROPOSING IMPORTANT HIV AGING RESEARCH AND A FEW SUPPORTING ESR RESEARCH. WE ARE NOW IN DISCUSSION WITH MULTIPLE OTHER ICs FOR ANOTHER SUCH OPPORTUNITY FOR ONE YEAR SUPPLEMENTS. IN I A DIVISION NIH OAR AND NIA FORM A THINK TANK SINCE LAST SEPTEMBER, WE HAD SOME EXCELLENT DISCUSSIONS AND WOULD LIKE TO THANK OUR NIA COLLEAGUES PARTICULARLY BASIL, STACY AND MELISSA. WE ARE DISCUSSING COMMUNITY NEEDS RESEARCH QUESTIONS THAT WILL BE IMPORTANT FOR HIV AND AGING RESEARCH AND STRATEGIES TO FACILITATE INTERDISCIPLINARY RESEARCH AND ACCELERATE IMPLEMENTATION OF RESEARCH RESULTS. NEXT SLIDE. BASED ON THINK TANK'S RECOMMENDATIONS, NIH OAR LAUNCHED A MULTI-IC HIV AND AGING WORKING GROUP, CO-LED BY NIH OAR AND NIA. TO FOCUS ON THERE ARE CURRENTLY TEN MEMBERS ICs REPRESENTING THE HIV AND AGING PORTFOLIO. THE WORK GROUP AND DIVERSE TOO LINK NIH COMMUNITY, THAT IS PEOPLE WITH NIH AND RESEARCHERS, AND RELEVANT US GOVERNMENT PARTNERS IN DISCUSSIONS TO FOST DEPOSIT COLLABORATIONS -- FOSTER COLLABORATIONS TO RESEARCH GAPS AND FACILITATE INTERDISCIPLINARY RESEARCH AND TRAINING IN HIV AND AGING SPACE. THE WORK GROUP IS ALSO DISCUSSING DIVERSE TO HOLD WORKSHOP THIS FALL. SO I WILL STOP HERE. >>GREAT, THANK YOU DR. BANSAL. SO THIS IS -- HAS BEEN A VERY INCIINSIGHTFUL RICH PART OF THE AGENDA. WE HAVE TIME FOR COMMENTS AND FEEDBACK FROM THE OARAC. HAVE HANDS GOING UP. SO WE WILL START WITH DR. SLEASMAN >>MY QUESTION IS MOSTLY FOR BASIL. BUT LEAVE IT UP TO ANYBODY TO ANSWER. REALLY HAS TO DO WITH THE ROLE OF OAR IN TRANS-INSTITUTE RESEARCH. SO ADULT CLINICAL TRIALS WITH THE ACTG, THEIR AVERAGE IN AGO OF THEIR ENROLLEES IN CLINICAL TRIALS THAT WERE 50, AND IT IS AN EXCELLENT OPPORTUNITY, TO BE EFFECTIVE AGING AND HIV INFECTED INDIVIDUALS. I WONDERED HOW MUCH TRANS-COOPERATION IS THERE BETWEEN AGING AND THE ACTG AND OTHER CLINICAL TRIAL NETWORKS THAT ARE INVOLVED? AND WHETHER OR NOT OAR CAN MAKE ANY RECOMMENDATIONS TO HELP FACILITATE THIS THROUGH TARGETED FUNDING OR CROSS-INSTITUTE WORKING GROUP. >>SO I WILL START, SURE MY COLLEAGUES WILL PROBABLY CHIME IN AS WELL. WE HAVE BEEN HAVING ONGOING CONVERSATIONS WITH THE ACTG LEADERSHIP, FOR A FEW YEARS NOW. AND ABSOLUTELY I THINK THAT THAT IS A VERY UNIQUE RESOURCE TO EXPLORE QUESTIONS OF AGING RESEARCH AND HIV. SO THOSE CONVERSATIONS ARE ONGOING, THERE ARE PROJECTS THAT WE HAVE OUR EYE ON. AND NOT SURE I CAN SAY MORE ABOUT THAT JUST YET. BUT IT IS CERTAINLY SOMETHING ON OUR RADAR. >>ARE YOU GUYS PROVIDING A DIRECTIVE YOU ARE THE AGING EXPERTS ARE YOU PROVIDING A DIRECT CONSULTATION WITH THE ACTG? >>SO WE HAVE BEEN CONVERSING WITH THEIR LEADERSHIP ABOUT AGING QUESTIONS, AND OUR PLAN IS TO DO MORE OF THAT. >>GREAT. THANK YOU. >>DR. MONTANER. >>YES, THANK YOU. IT IS JUST A COUPLE OF OBSERVATIONS AND SUGGESTIONS. THAT I WAS REALLY IMPRESSED BY THE PROGRAM THAT WAS PRESENTED ON THE SUPPLEMENTS RELATIVE TO EXISTING RESEARCH GEARED TOWARDS AGING AND ALZHEIMER'S AND I WANTED TO PERHAPS ENCOURAGE DIALOGUE WITH THE RCA MY PROGRAM, MINORITY INSTITUTION PROGRAM FOR THE CENTERS BECAUSE YOU KNOW, I REVIEW A LOT OF PILOTS AT LEAST TWO OR THREE AND THEY HAVE A LOT OF INITIATIVES THAT WOULD FOSTER BOTH DIVERSITY AND DIRECTED RESEARCH TOWARDS NIA OBJECTIVES AT THE SAME TIME. SO I WOULD ENCOURAGE SOME DIALOGUE BETWEEN THESE PROGRAMS TO TRY TO SYNERGIZE EXISTING EFFORTS THAT ALREADY HAVE IDENTIFIED DEVELOPMENT OF DIVERSE WORK FORCE FROM -- AND N,A OBJECTIVES ON RESEARCH BECAUSE IT SEEMED TO BE SOME SILOED ISSUES HERE AN EVERYONE IS TRYING TO DO THE SAME THING BUT IF THERE COULD BE MORE COALITION THAT WOULD BE EXCELLENT. THE SECOND POINT IS FOLLOWING JOHN'S COMMENT OF TRANS-RESEARCH BECAUSE I SEE NIA IS NOT ONE OF THE FUNDERS OF MARKING ANY COLLABORATORY ON -- BUT WE AS A WHOLE GROUP, THIS IS A GROUP OF TEN INITIATIVES, THAT PRIMARILY BY THE NIAID AND WITH MULTIPLE PARTNERS. AND THE FIELD IS MOVING MORE TOWARDS TRYING TO GET A GREATER UNDERSTANDING OF LONG TERM ART. 20 YEARS MORE ART ON THE BURDEN OF EPIGENETICS AND AGING STARTS TO COME INTO FOCUS AS AN AREA AND AGAIN, A SUPPLEMENTING INITIATIVE THAT IS TIED TO THE COLLABORATORY COULD SPIN OFF RO1s THAT WOULD GO INTO THE EXISTING PROGRAM ANNOUNCEMENTS SO THAT IS SOMETHING ELSE THAT I WOULD ENCOURAGE YOU TO AT LEAST CONSIDER. >>I AGREE WITH YOU ON BOTH. >>DO WE HAVE ANY OTHER COMMENTS? DR. GANDHI? >>YES, WE -- THESE WERE GREAT PRESENTATIONS, WE HAVE A GEMSSTAR AT UCSF THROUGH THE GOLDEN COME PASS PROGRAM, WHICH IS A COMPREHENSIVE CARE PROGRAM FOR PEOPLE WHO ARE OLDER LIVING WITH HIV. THE QUESTION I HAVE IS THAT THERE'S BASIC SCIENCE ON AGING, BASIC SCIENCE ON CHRONIC INFLAMMATION AND THERE IS INCREASINGLY IMPLEMENTATION SCIENCE. AND TRYING TO WORK ON PROGRAMS THAT BEYOND THE PATHOPHYSIOLOGY DIRECTLY WORK ON LINKING PEOPLE TO CARE, THIS IS WHAT OUR PROGRAM DOES, PROVIDING CARDIOLOGY CARE EARLIER FOR THOSE WHO ARE OLDER, PROVIDING -- WE PROVIDE MEMORY CARE, BRAIN HEALTH CLASSES, WE PROVIDE DEXs EARLIER. IT IS A VERY CLINICAL PROGRAM, THE GOLDEN COMPASS PROGRAM. WONDERING ABOUT THE INTEREST FROM OFFICE OF AIDS RESEARCH TO PUSH FOR MORE GEMSSTAR OR IMPLEMENTATION SCIENCE STUDIES ON AGING. BEYOND THE PATHOPHYSIOLOGY, IF YOU DON'T ACCELERATE CARE, MORE QUICKLY FOR PEOPLE WHO ARE YOUNGER WITH HIV BECAUSE THEY ARE AGING INTERNALLY AT EARLIER RATES, IT IS REALLY ABOUT CLINICAL CARE PROGRAMS I THINK. AND EVALUATING CLINICAL CARE PROGRAMS. >>IF I MAY YOU MADE A VERY NICE POINT, DR. GANDHI. ONE OF THE GOALS AND ONE OF THE THINGS WE HAVE DISCUSSED WITH NEA AND OUR THINK TANK AN DISCUSSING WITH NIH WORKING GROUP IS HOW TO FACILITATE FOSTERING IMPLEMENTATION OF RESEARCH AS A RESULT SO EVIDENCE BASED INTERVENTIONS AND STRATEGIES ARE DEVELOPED WITH NIH FUNDED RESEARCH BUT HOW CAN THEY ACTUALLY REACH CLINIC FASTER. SO ONE OF THE GOALS OF THE WORKING GROUP, AND THAT IS WHAT OUR ENDEAVOR IS TO LINK RELEVANT PARTNERS TOGETHER, WITH -- AND HAVE DISCUSSIONS THAT WOULD BE INFORMED AND INVOLVED WITH THE COMMUNITY SO THAT WE CAN ADDRESS ALL THOSE NEEDS. >>THANK YOU. >>DR. -- THIS WILL BE THE LAST QUESTION WE WILL TAKE THE SESSION. >>THANK YOU ALL THIS IS A REALLY FANTASTIC INITIATIVE. JUST WANTED TO POINT OUT FROM THE BASIC SCIENCE SIDE, FROM HIV RESEARCH, THERE'S MANY CLEAR MOLECULAR LINKS WITH THE AGING PATHWAYS THAT HAVE BEEN DISCOVERED IN THE PAST BY US AND OTHERS. YOU KNOW, HIV PROTEINS DIRECTLY INTERFERE WITH AGING RELATED PROTEINS LIKE -- IT IS REALLY SOMETHING THAT HAS BEEN INCREDIBLY INTRIGUING FROM THE BEGINNING. AND I THINK ESPECIALLY ALSO BASIC SCIENCE RESEARCH PROGRAMS EXPLORING THIS BETTER AND GETTING A BETTER MOLECULAR INSIGHT HERE ARE NEEDED TO FULLY ELUCIDATE THIS VERY INTRIGUING INTERACTIONS THAT MIGHT HAVE STRONG CLINICAL IMPLICATIONS. >>I SEE A FEW NODS THERE AN AGREEMENT DR. OTT. I APPRECIATE THAT COMMENT AND WE HAVE TO MOVE INTO THE BREAK. YOU HAVE ABOUT 13 MINUTES TO STRETCH AND WALK AROUND HIS NECK A BITE TO EAT AND WILL START PROMPTLY AT 1:15 WELCOME BACK FROM THE SHORT BREAK. WE WANT TO CONTINUE WITH THE AGENDA HERE. AND IF YOU LOOK IN YOUR BRIEFING BOOK, YOU WILL SEE THAT WE HAVE THRE TALKS IN THE NEXT PART OF THE AGENDA, AND WE'LL FOLLOW THOSE WITH A SHORT DISCUSSION SESSION SO LET ME GO AHEAD AND INTO THE FIRST TWO SPEAKERS IN THE SESSION THOSE WOULD BE DOCTORS JUDY LEVISON AND DR. THEODORE RUEL. DR. LEVISON IS PROFESSOR OF OBSTETRICS & GYNECOLOGY AND FAMILY AND COMMUNITY MEDICINE, BAYLOR COLLEGE OF MEDICINE, MEMBER, TREATMENT OF HIV DURING PREGNANCY AND PREVENTION OF PERINATAL TRANSMISSION PROVIDES CONSULTATION FOR THE NATIONAL PERINATAL HOTLINE. AND WORK IN THE AREA OF HIV HAD LED HER TO CONSULT ON PROJECTS WORLDWIDE IN HER WORK IS THE FIRST IN THE UNITED STATES TO DEVELOP A CURRICULUM FOR GROUP PRENATAL CARE FOR WOMEN LIVING WITH HIV, AND TO FOLLOW THE OUTCOMES OF THAT PROGRAM. DR. RUEL IS PROFESSOR OF PEDIATRICS, CHIEF, DIVISION OF PEDIATRIC INFECTIOUS DISEASES AND GLOBAL HEALTH, DIRECTOR, PEDIATRIC INFECTIOUS DISEASES FELLOWSHIP, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO BENIOFF CHILDREN’S HOSPITAL, CO-CHAIR, PANEL ON ART AND MEDICAL MANAGEMENT OF CHILDREN LIVING WITH HIV THE RESEARCH FOCUSES ON OPTIMIZATION AND OUTCOMES FOR CHILDREN LIVING WITH HIV INFECTION AND DR. RUEL SERVES AS COCHAIR PEDIATRIC RETROVIRAL PANEL TO PUBLISH CHILDREN'S GUIDELINES FOR CHILDREN IN THE UNITED STATES AND IS VICE CHAIR OF THE WORLD HEALTH ORGANIZATION SO DR. LEVISON I WILL PASS IT OVER TO YOU NOW. >>DR. LEVISON: THANK YOU SO MUCH FOR GIVING US THE OPPORTUNITY TO TELL YOU ABOUT CHANGES IN THE NEW RECOMMENDATIONS FOR INFANT FEEDING AND PREVENTION OF PEDIATRIC HIV INFECTION IN THE US, WHAT THEY ARE AND WHY NOW. I HAVE NO DISCLOSURES. HOPE BY THE END YOU WILL BE ABLE TO DESCRIBE SOME OF THE CHANGES IN THE PERINATAL HIV GUIDELINES RELEASED ON JANUARY 31 OF THIS YEAR WHICH DISPLAYS THE SCIENCE AND THE SOCIAL CONTRACT THAT SUPPORTED THOSE CHANGES. FIRST OF ALL WHAT HAS BEEN THE FEEDING GUIDELINES FOR PEOPLE LIVING WITH HIV? HTLV-III/LAV-INFECTED WOMEN SHOULD BE ADVISED AGAINST PROCEEDING TO AVOID POSTNATAL TRANSMISSION TO A CHILD WHO MAY NOT GET INFECTED IN 2015 WAS A BIG STEP FORWARD IN THE PERINATAL GUIDELINES AND ONE SENTENCE WAS ADDED. IN DISCUSSING THE AVOIDANCE OF BREAST-FEEDING IS A STRONG STANDARD RECOMMENDATION FOR HIV-INFECTED WOMEN IN THE UNITED STATES. THE PANEL NOTES THAT WOMEN MAY FACE SOCIAL, FAMILIAL, AND PERSONAL PRESSURES TO BREAST-FEED DESPITE THIS RECOMMENDATION THAT IS IMPORTANT TO BEGIN ADDRESSING POSSIBLE BARRIERS TO FORMULA FEEDING DURING THE ANTENATAL PERIOD. NEXT SLIDE. 2018 WAS A LITTLE DIFFERENT. AT AN ENTIRE NEW SECTION WAS ADDED TO THE GUIDELINES. SOME OF THE LANGUAGE WERE STILL PRETTY NEGATIVE AND THE SECTION OPEN WITH THE FOLLOWING: BREAST-FEEDING IS NOT RECOMMENDED FOR WOMEN LIVING WITH HIV IN THE UNITED STATES AND WOMEN WHO HAVE QUESTIONS ABOUT BREAST-FEEDING OR WHO DESIRE TO BREAST-FEED SHOULD RECEIVE PATIENT CENTERED, EVIDENCE BASED COUNSELING ON INFANT FEEDING OPTIONS. WIN-WIN MEN WITH HIV CHOOSE TO BREAST-FEED DESPITE INTENSIVE COUNSELORS SHOULD BE COUNSELED TO USE HARM REDUCTION MEASURES TO MINIMIZE THE RISK OF HIV TRANSMISSION. YOU CAN SEE HIGHLIGHTED IN YELLOW THAT IS OUR SIGNAL AND THE GUIDELINES PANEL THAT THESE THINGS ARE NEW. AND FOR THOSE OF YOU WHO HAVE SEEN THE GUIDELINES, YOU WILL RECOGNIZE THIS FORMAT. NEXT SLIDE PLEASE. THE MAJOR CHANGES THE FOLLOWING. THE PRIMARY RECOMMENDATION IS NOT TO SUPPORT PARENTAL CHOICE THROUGH SHARED DECISION-MAKING AND NOT A SPECIFIC INTERFEEDING MODE. NEXT SLIDE. THIS IS SOME OF THE THINGS WE TOOK INTO CONSIDERATION IN WAYS THAT DON'T THINK WE HAD BEFORE. FIRST THE HEALTH BENEFITS FROM BREAST-FEEDING. FOR THE INFANT WE KNOW THAT THERE IS A LOWER RISK OF INFANTS DEVELOPING ASTHMA, OBESITY, TYPE I DIABETES, RESPIRATORY DISEASE, OTITIS MEDIUS -- AND FOR THE PROCEEDING PARENT ARE ALSO ADVANTAGES DECREASED RISK OF HYPERTENSION, AND REDUCING RISK OF BREAST AND OVARIAN CANCERS. BLACK WOMEN ARE DISPROPORTIONATELY AFFECTED BY HIV AND PEOPLE OF COLOR EXPERIENCE A GREATER BURDEN OF MANY HEALTH CONDITIONS THAT MAY BE ALLEVIATED BY BREAST-FEEDING. CULTURAL CONSIDERATIONS: ENVIRONMENTAL SOCIAL AND FAMILIAL PRESSURE TO CONSIDER BREAST-FEEDING AND THE FEAR THAT NOT BREAST-FEEDING WOULD LEAD TO DISCLOSURE OF THEIR HIV STATUS. NEXT SLIDE. SO, WHAT IS THE RISK OF HIV VIA BREASTFEEDING? WITHOUT MATERNAL INFANT PROPHYLAXIS THE RISK IS ABOUT 15-20% OVER TWO YEARS IN ACHIEVING AND MAINTAINING VIRAL SUPPRESSION DURING ART AND POSTPARTUM DECREASES TRANSMISSION RISK LESS THAN 1% BUT NOT ZERO. NEXT SLIDE. AND I THINK YOU'RE GOING TO TAKE IT FROM HERE. >>DR. RUEL: THANKS JUDY SO WE ARE NOT GOING TO TURN TO LOOK AT SOME OF THE CONTENT AND HOW THERE ARE KEY PARTS FOR PEOPLE RECOGNIZING THERE IS MUCH THAT WE WON'T BE ABLE TO HIGHLIGHT TODAY. TO START WITH THE OVERVIEW, AND COUNSELING AND MANAGEMENT, FOR PEOPLE WITH HIV WHO ARE NOT ON TREATMENT AND DO NOT HAVE SUPPRESSED VIRAL LOAD AT THE TIME OF DELIVERY RECOMMENDATIONS REMAIN THE SAME WHICH IS REPLACING FEEDING FORMULA OR BANK PASTEURIZED DONOR HUMAN MILK IS RECOMMENDED TO LIMIT THE RISK OF HIV TRANSMISSION. AND OF COURSE NEW CONTENT IS FOR INDIVIDUALS WITH HIV ON TREATMENT WILL HAVE A CONSISTENTLY SUPPRESSED VIRAL LOAD DURING PREGNANCY WHICH INCLUDES AT A MINIMUM THROUGH THE THIRD TRIMESTER AND AT THE TIME OF DELIVERY. THE IDEA IS THAT THEY SHOULD BE COUNSELED OPENLY ON DIFFERENT OPTIONS, FROM FORMULA FEEDING BANKED DONOR MILK, OR BREAST-FEEDING. INFANT FEEDING OPTIONS THAT ELIMINATE THE RISK OF TRANSMISSION OUR FORMULA AND THAT MILK AND RECOGNIZING THAT FULLY SUPPRESSIVE ART DURING PREGNANCY AND BREAST-FEEDING DECREASES PRESSING TRANSMISSION TO LESS THAN 1%, BUT WE CANNOT SAY ZERO YET. NEXT SLIDE. THE HIGHLIGHTS ALSO HIGHLIGHT WHAT TO DO IF THERE IS CONCERN ABOUT -- BREAST-FEEDING SHOULD BE STOPPED. REPLACING WITH FEEDING FORMULA. BUT THE VIRAL LOAD IS DETECTABLE THERE IS REALLY A SHIFT IN THE GUIDANCE BACK TO THE MORE DIRECTIVE IDEA OF CESSATION OF BREAST-FEEDING, AND INITIATION OF A GREATER DEGREE OF PROPHYLAXIS FOR THE INFANT IN THAT CONTEXT. NEXT SLIDE. SO ONE OF THE MORE CHALLENGING PARTS OF THE GUIDANCE WAS TO GET CONSENSUS ON WHAT TO DO WITH PROPHYLAXIS FOR INFANTS WHO ARE BREAST-FEEDING IN THIS CONTEXT. THERE WAS REAL DIVERSITY ACROSS THE PANEL. MOST PANEL MEMBERS AGREED THAT TWO WEEKS OF ZDV AS YOU WOULD WITH HIGHER OR LOWER RISK WOULD BE SUFFICIENT BUT SOME FELT THAT FULL ACCESS OR LONGER, 4-6 WEEKS WHICH WAS UNTIL A FEW YEARS AGO WAS OUR STANDARD WOULD BE PREFERRED. IN SOME RECOMMENDED SIX WEEKS WITH NEVIRAPINE AND SOME OTHERS OPTED FOR CONTINUATION OF PROPHYLAXIS SUCH AS NEVIRAPINE FOR THE DURATION OF BREAST-FEEDING AND THE LAST SLIDE HIGHLIGHTS ONE OF THE BIG CHALLENGES WITH THIS VERSION. YOU KNOW RECOMMENDING AND SUPPORTING BREAST-FEEDING NOW MEANT WE HAD TO DEVELOP A LOT OF NEW CONTENT AROUND WHAT TO DO. FOR INSTANCE WHEN SOMETHING LIKE MASTITIS HAPPENS. THERE'S A LOT OF NEW CONTENT THERE BUT A LOT OF IT IS MADE UP TO ADDRESS THE NEW CHALLENGES WE HAVE NOW. AND WE REALLY REALIZE THAT THERE ARE A LOT OF GAPS THE PROCESS THAT LIMIT WHAT WE CAN SAY, IN THE STRENGTH OF THE RECOMMENDATIONS. TO DATE NEW STUDIES HAVE SYSTEMATICALLY EVALUATE THE RISK OF TRANSMISSION THROUGH BREAST-FEEDING IN THIS CONTEXT OF AFFECTED MATERNAL TREATMENT THAT WE HAVE AND WE KNOW DATA THAT EXIST IN THE FREQUENCY OF VIRAL LOAD TESTING FOR THE INFANTS AND MOTHERS. A LOT OF THIS IS PUT OUT THERE AS OUR BEST ESTIMATES ON THE CATEGORY OF MORE EXPERT GUIDANCE AND UNFORTUNATELY NOT DRIVEN BY AS MUCH DATA BY WE WOULD LIKE. WANTED TO HIGHLIGHT THE LAST PART OF THE CONTENT. ENGAGING CHILD PROTECTIVE SERVICES OR SIMILAR AGENCIES IS NOT AN APPROPRIATE RESPONSE TO INFANT FEEDING CHOICE OF AN INDIVIDUAL WITH HIV. IN THIS REALLY POINT TO A REAL PROBLEMATIC HISTORY IN THE RELATIONSHIP BETWEEN PROVIDERS, PARENTS AND THEIR INFANTS HISTORICALLY THAT HAS LED TO A LOT OF HARM AND TRAUMA IN PARENTING AND THE FAMILY STRUCTURE AND THIS IS REALLY IMPORTANT TO MEMBERS OF THE COMMUNITY AND PROVIDERS TO INCLUDE SPECIFICALLY AS THE GUIDELINES SHOW HIGHLIGHTED IN THE MAIN BOX. NEXT SLIDE. SO, TO HIGHLIGHT A FEW NEW THINGS ABOUT THE PROCESS THIS YEAR. AS YOU MENTIONED, THERE WAS EARLY IMPORTANT , INPUT FROM THE COMMUNITY THAT LED TO THIS CHANGE. MEMBERS OF THE WELL PROJECT INTERNATIONAL COMMUNITY OF WOMEN LIVING WITH HIV IN NORTH AMERICAN OTHERS, INDIVIDUALS AND FAMILIES AND PEOPLE IN THE PANEL HAVE WORKED WITH; ANOTHER KEY CONTRIBUTOR WERE LACTATION SPECIALISTS FROM THE CDC THAT GUIDANCE TO HELP US. THERE WAS A NEW LEVEL OF COLLABORATION BETWEEN PERINATAL AND PEDIATRIC PANELS. WE WORK TOGETHER IN THE PAST BUT THIS WAS MUCH MORE INTERACTIVE WITH CO-EDITING OF THE KEY PORTIONS OF THE GUIDELINES. THIS IS SOMETHING WE ANTICIPATE WILL BE A LASTING THERE IS LESS OF A RISK OF PARALLELING AND SLIGHTLY NUANCED OUT THERE. NEXT SLIDE. SO WE WANTED TO FINISH BY POINTING OUT THAT THIS CHANGE IN THE GOVERNANCE COME TO THE RIGHT TIME WHAT WE SEE HERE ARE CALLED TO THE NATIONAL CLINICAL CONSULTATION CENTER FOR BOTH JUDY AND I WORK. AS MANY OF YOU KNOW WE SUPPORTED THE ENDEAVOR REFERRED TO A LOT IN THE GALLONS WERE WE TO QUESTIONS ABOUT THE GUIDELINES. AND YOU CAN SEE THE HEIGHT OF THE BARS IS THE PORTION OF CALLS TO THE PERINATAL GUIDELINES, IN WHICH BREAST OR CHEST BEATING WERE DISCUSSED STARTING IN 2014 AT SOMETHING LIKE 4% OF CALLS UP THE LAST YEAR OVER 1/4 OF CALLS CONCERNED INTEREST IN BREAST/CHEST FEEDING, IMPORTANT TIME TO PROVIDE GUIDANCE TO THIS RISING INTEREST IN PROVIDERS AND FAMILIES. NEXT SLIDE. AND TO FURTHER SUPPORT THAT, THIS IS A STUDY THAT WAS DONE BY SOME RESIDENTS AT UCSF THAT REACHED OUT TO US TO HELP WITH THIS PROJECT AS WELL. THIS WAS A SERVICE PROVIDERS ACROSS THE US, AND IT FOUND REALLY HIGHLIGHTED THE DISCOMFORT THAT WAS FELT BY PROVIDERS AT THIS TIME. THIS WAS BASICALLY TO 2021 INTO 2022. 42% HAD CARED FOR PEOPLE WITH THIS INTEREST BUT ONLY 10% HAD AN INSTITUTIONAL PROTOCOL AND REALLY ALL OF THEM EXPRESSED DISCOMFORT WITH NOT HAVING GUIDANCE. TRYING TO NAVIGATE THE PERSONAL SENSE OF ETHICS TO DISAGREEMENTS ACROSS PROVIDERS, TRYING TO ALIGN WITH HOSPITAL POLICIES AND NOT GET IN TROUBLE, A LOT OF FEAR AND A LOT OF DISCOMFORT AS THEY TRY TO BALANCE DESIRES TO ADDRESS PERSON'S CHOICE BUT ISSUES WITH PATERNALISM AND THE FORMAL STRUCTURE OF THE GUIDELINES OUT THERE, SO COMING OUT AT A GREAT TIME. >>DR. LEVISON: SO IN ADDITION PATIENTS IN THE US HAVE STRUGGLED TO NAVIGATE THE INFANT FEEDING OPTIONS IN THE ABSENCE OF MORE GUIDANCE. THERE HAVE BEEN SOME WOMEN WHO HAVE GONE FROM DOCTOR TO DOCTOR UNTIL THEY FOUND SOMEONE WHO WOULD SUPPORT WHAT THEY WANTED TO DO. AND IT HAS LED TO A LOT OF MISTRUST. AS ONE PERSON SAID THE FIRST THING YOU HAVE TO DO AS A HEALTHCARE PROVIDER IS RESTORE TRUST. I NEED A HEALTHCARE PROFESSIONAL AND NOT AN INVESTIGATIVE. AND THEN CC KOVIN (PHONETIC) WHO HAS BEEN A REALLY ARTICULATE SPOKESPERSON FOR THE COMMUNITY SAID THAT IT IS VERY IMPORTANT THAT WE ARE GIVEN A CHOICE, NOT GIVEN A CHOICE LIKE I JUST NEED TO SUPPORT WHAT MY DECISION IS. IT IS NOT MY PROVIDER'S PLACE TO TELL ME WHAT TO DO WITH MY LEFT AND MY BABIES I NEED YOU TO LEAVE THE SPACE OPEN FOR DISCUSSION AND CHOICE. AND THE RESOURCES THAT WE ADVISE EVERYBODY IN EVERY TALK TO CONSIDER ARE THE HIV-INFO @NIH.GOV GUIDELINES WHERE YOU HAVE THE PEDIATRIC AND PERINATAL GUIDELINES AND THE NATIONAL WILL INITIAL CONSULTATION CENTER AND AT THE PEOPLE AT THE BEGINNING OF EVERY TALK IF YOU DO NOT REMEMBER ANYTHING ABOUT WHAT I SAID PUT THIS NUMBER AND PUT IT IN YOUR PHONE. NEXT SLIDE. WE HAVE SOME REALLY DEEP ACKNOWLEDGMENTS TO OUR PATIENTS, THE PERINATAL PANEL AND A PEDIATRIC PEBBLE IN THE CDC. THE OFFICE OF AIDS RESEARCH ADVISORY COUNCIL AND THE WELL PROJECT SPECIFIC INDIVIDUALS WITHOUT WHOM THIS WOULD NOT HAVE HAPPENED. DEB STORM, WHO MANY OF YOU KNOW HAVE LED THE PANEL THROUGH MANY EDITS TO REACH CONSENSUS AND I BET WE HAVE A RECORD FOR HOW MANY EDITS, HOW MANY VERSES WE WENT THROUGH AND ATHENA KOURTIS OUR VOICES CDC AND LEALAH POLLOCK CO-AUTHOR ON THE BULK OF INFANT FEEDING GUIDELINES AND ELAINE ABRAMS. WITH THANK YOU. >>CHAIR TOLBERT: THANK YOU DRS. LEVINSON AND RUEL FOR THE PRESENTATION WE WILL MOVE ON COLLEAGUES WITH OUR VERY OWN ORAC MEMBER DR. MILLER AND, EXECUTIVE DIRECTOR FOR FORUM OF COLLABORATIVE RESEARCH, UNIVERSITY OF CALIFORNIA, BERKELEY. SHE DEVELOPED AND TAUGHT A COURSE BASED ON CASE STUDIES FROM THE FORUMS, RICH HISTORY OF FACILITATING BOTH AT THE FDA AND DRUG DEVELOPMENT. SHE MENTORS INTERNS AND FELLOWS PURSUING REGULATORY BIOTECH AND TRANSLATIONAL MEDICINE CAREERS. DR. MILLER SERVES ON NUMEROUS INDUSTRY AND GOVERNMENT ADVISORY BOARDS AND HAS PUBLISHED EXTENSIVELY ON REVELATORY STRATEGIES RELATED TO HIV AND HCV. I WILL HAND IT OVER TO A COLLEAGUE DR. MILLER. >>DR. MILLER: THANK YOU SO MUCH FOR THAT VERY KIND INTRODUCTION. AND IT IS MY PLEASURE-- IT IS ACTUALLY MY HONOR-- TO BE ABLE TO GIVE SOME FEEDBACK ON ONE OF OUR RECENT WORKSHOPS. DO I MOVE THE SLIDE FORWARD? >>I WILL ADVANCE THEM FOR YOU. >>DR. MILLER: GREAT PLEASE. FIRST OF ALL I WANTED TO GIVE A HUGE APPLAUSE AND THANK YOU TO ALL OF OUR WORKSHOP PLANNING GROUP MEMBERS. I WANT TO POINT OUT THAT IT WAS MONICA GANDY WHO IS ALSO ON THE CALL TODAY, AND TIM WOOKEN (PHONETIC) FROM CORNELL UNIVERSITY WHO APPROACHES WITH SOME CHALLENGES THEY WERE SEEING WITH RESPECT TO THE ACTG PROGRAM AND CLINICAL TRIALS, USING NON-ACTING RETROVIRAL. WHEN WE AGREED THAT THE FORUM , ON THIS OR AT LEAST THE FIRST ONE ALSO POSSIBLY A SERIES OF WORKSHOPS, WE SAID OKAY BUT LET'S TAKE THIS OUTSIDE THE BROADER-- INTO A BROADER CONTEXT SO IT IS NOT JUST AN ACTG-FOCUSED ISSUE BUT REALLY KIND OF TAKING A BROADER VIEW OF WHO ARE THE PATIENTS THAT MOST NEED LONG-ACTING TREATMENT AND WHAT ARE THE ISSUES AND HOW CAN WE AS A BROADER HIV COMMUNITY START DEALING WITH THIS? ALSO THANK YOU FOR MENTIONING OUR INTERNS IN YOUR INTRODUCTION. NAYRI ALAJALI, HER NAME STARTS WITH A AND THAT IS WHY SHE IS AT THE TOP BUT YOU SHOULD ALSO BE AT THE TOP BECAUSE SHE DID ALL OF THE HEAVY LIFTING FOR ORGANIZING THIS REPORT AND USING AN ADAPTIVE WILL REPORT SHE IS WORKING ON FOCUSING SPECIFICALLY ON REIMBURSEMENT HOME ISSUES THAT SHE WILL BE PRESENTING FOR HER GRADUATION FROM THE MPH PROGRAM. AND SO AS YOU CAN SEE, THIS IS THE BROAD STAKEHOLDER GROUP THAT THE FORUM WORKS WITH AND WE HAVE INDUSTRY AND GOVERNMENTAL AGENCIES, AND ACADEMIC RESEARCHERS ALL COMING TOGETHER TO TRY AND DEAL WITH THE ISSUES. NEXT SLIDE. SO THE OVERALL WORKSHOP GOAL THEN WAS TO IMPROVE ACCESS TO LONG-ACTING ANTIRETROVIRAL THERAPY BUT PEOPLE WHO MOST NEED THESE THERAPIES AND THIS IS A VERY HIGH-LEVEL GOAL THAT WE HAVE TRIED TO ADDRESS. WHEN WE TALK ABOUT PEOPLE WHO MOST NEED THESE THERAPIES, THERE'S SO MANY DIFFERENT WAYS TO DESCRIBE THEM. BUT I THINK PEOPLE THAT HAVE CHALLENGES WITH ADHERING TO A DAILY ORAL REGIMEN, FOR MANY DIFFERENT REASONS, BUT ALSO PEOPLE WHO HAVE BEEN HISTORICALLY UNDERREPRESENTED IN CLINICAL RESEARCH. I WANT TO POINT OUT HERE THE VERY BEGINNING THAT WHEN WE TALK ABOUT ACCESS, WE DON'T JUST MEAN THAT THEY CAN JUST GO AND GET THE DRUGS. WE WANT RECOGNITIONS FOR SAFE AND EFFECTIVE USE AND WE WANT THESE THERAPIES TO BE AVAILABLE AND ALSO ADMINISTERED, SO WHEN WE ARE TALKING ABOUT LONG-ACTING INJECTABLES, IT IS A DIFFERENT MATTER THAN JUST GOING TO THE PHARMACY AND GIVING THEM YOUR PRESCRIPTION. THEY ALSO NEED TO BE REIMBURSABLE ACCESS REALLY ENTAILS QUITE A FEW DIFFERENT, SOMETIMES KIND OF STICKY KIND OF POLICY ISSUES THAT WE NEED TO GET THROUGH. NEXT SLIDE. SO AS WE WORKED WITH OUR PLANNING GROUP, WE STARTED TO THINK ABOUT WHAT ARE SOME OF THE CONSIDERATIONS THAT WE NEED TO INCLUDE AS WE THINK OF THIS TOPIC? ONE OF THE FIRST ONE IS THAT YOU KNOW WE REALLY NEED TO ACCEPT AND RECOGNIZE THE FACT THAT IT IS IMPORTANT FOR PEOPLE WHO WILL STAND TO BENEFIT FROM NEW THERAPEUTIC INTERVENTIONS TO ACTUALLY BE INVOLVED IN THE CLINICAL RESEARCH THAT ASSESSES THE SAFETY AND EFFICACY OF THESE INTERVENTIONS. THIS IS SO IMPORTANT AND WE COULD DO A WHOLE DAY WORKSHOP JUST ON THE BENEFITS OF PARTICIPATING IN CLINICAL RESEARCH. AND THESE BENEFITS ARE EVIDENT BOTH AT THE INDIVIDUAL AND COMMUNITY LEVELS. SO IT IS REALLY IMPORTANT TO NOT TO CONTINUE HAVE HISTORICALLY UNDERREPRESENTED POPULATIONS IN THE CLINICAL RESEARCH PARADIGM AND THIS GOES FOR ALL DISEASES. THIS IS NOT UNIQUE TO HIV. ANOTHER BIG CONSIDERATION IS THAT MANY PEOPLE ARE EXCLUDED IN EARLY-- ESPECIALLY PREAPPROVAL-- CLINICAL RESEARCH AND OFTEN THIS IS FOR SAFETY REASONS. AND THAT IS SOMETHING WE NEED TO WORK WITH. AND I PUT HERE A SPECIAL POPULATIONS IN QUOTATION MARKS. IN THIS CASE WE ARE TALKING FOR EXAMPLE PEOPLE WHO INJECT DRUGS, HAVE MENTAL HEALTH ISSUES AND/OR OTHER COMORBIDITIES BUT ALSO PATIENTS IN RURAL SETTINGS WHO ARE FAR AWAY FROM TRADITIONAL CLINICAL TRIAL CENTERS. AND AND THEY MAY HAVE DIFFERENT ISSUES THAT THEY ARE DEALING WITH IN THEIR DAILY LIVES FROM PEOPLE LIVING IN URBAN CENTERS. BUT IT IS-- THERE ARE REASONS WHY WE NEED TO BE VERY CAREFUL ABOUT THE SAFETY EARLY ON. BUT WE NEED TO RECOGNIZE THAT. AND PLAN FOR INCLUSION IN CLINICAL TRIALS AS SOON IT IS LEGITIMATE TO DO SO. AND WE REALLY LACK-- AS A RESULT OF THIS HAVING NOT INCLUDED MANY OF THESE PATIENTS-- WE LACK INFORMATION AT THE TIME OF APPROVAL ON HOW THESE DRUGS COULD SAFELY BE USED, AND THEIR EFFECTIVENESS IN WHAT I CALL "REAL-WORLD PATIENTS." PATIENTS THAT DEAL WITH ALL OF THE REAL ISSUES OF MENTAL HEALTH, ADDICTION, UNSTABLE HOUSING, ETC., ETC. NEXT SLIDE. OH, IN THE SOUL ABOUT THE BENEFIT IN RISK. IT WILL BE DIFFERENT IN DIFFERENT POPULATIONS SO WHAT BENEFIT WE EXPECT AND WHAT RISK WE ARE WILLING TO LIVE WITH WHEN WE TALK ABOUT PEOPLE WITH UNIQUE NEEDS WHO ARE REALLY EXPERIENCING AN UNMET MEDICAL NEED. AND THE DIFFERENT RISKS WE MAY TALK ABOUT, MAY BE VIEWED DIFFERENTLY IN THESE PREPARATIONS OF THE OTHER CONSIDERATIONS WE INCLUDED ARE IN THE NEXT SLIDE. AT THE MOMENT WE ONLY HAVE ONE REGIMENT THAT IS LONG-ACTING INJECTABLE APPROVE FOR TREATMENT AND I AM USING CABENUVA HERE IS A SHORT FORM, AND SOME OF THE ISSUES ARE VIROLOGICALLY SUPPRESSED, NO PREVIOUS TREATMENT FAILURES AND RELEVANT RESISTANT MUTATIONS TO A VERY SPECIFIC INDICATION. IN THE FUTURE THAT MIGHT NOT BE THE CASE ESPECIALLY WE ALL DECIDE WE ARE GOING TO LEARN AS MUCH AS WE CAN FROM THIS FIRST ITERATION OF LONG-ACTING ART, AND APPLY THOSE LESSONS TO ADDITIONAL REGIMENTS AS WE CAN FORWARD. AND POSSIBLY FOR FUTURE LA ART WE CAN THINK ABOUT HOW WE CAN PLAN AHEAD FOR SEAMLESS TRANSITION TO DIVERSE POPULATIONS BEFORE THE TIME OF APPROVAL. SO LET'S LEARN AS MUCH AS WE CAN FROM THIS FIRST THERAPY. BUT THEN ALSO THINK TOWARDS THE FUTURE AND SEE HOW THAT MIGHT BE DIFFERENT. BUT BECAUSE THIS IS THE ONLY ONE THAT IS APPROVED, A LOT OF THE DISCUSSION FOCUSED ON THE SPECIFIC DRUG LABEL AND ISSUES RELATED TO THIS PARTICULAR THERAPY. NEXT SLIDE. SO THE OBJECTIVE THEN OF THE WORKSHOP WAS TO IDENTIFY AND DISCUSS CHALLENGES AND THE EXECUTION OF CLINICAL TRIALS AND ASSESSING THERAPIES FOR POPULATIONS MOST AT NEED FOR SUCH SERVICE AND TO FIND RECOMMENDER SOLUTIONS TO SOME OF THESE CHALLENGES. NEXT SLIDE. WE TALKED ABOUT ABOUT WHAT CAN WE LEARN FROM OTHER FIELDS SUCH AS PSYCHIATRY AND WE SPENT A LOT OF TIME ON THE PATIENT PERSPECTIVE ON THE IMPACT OF LONG-ACTING THERAPIES IN THE ROLE OF CLINICAL TRIAL NETWORKS. AND EVIDENCE GENERATION FOR THE SAFETY AND EFFICACY AND ADHERENCE TO CHALLENGE POPULATION BOTH IN PREAPPROVAL AND POST PREAPPROVAL CLINICAL RESEARCH PHASE AND THE ROLES, THE DIFFERENT ROLES THAT THE REGULATORY PROCESS WHICH RESULTS IN A DRUG LABEL OR THE INDICATION FOR USE, IN CLINICAL PRACTICE WHICH IS REALLY THE TREATMENT GUIDELINES. AND FACILITATING AND ENSURING ACCESS, I PUT HERE THE WEB LINK TO ALL OF THIS INFORMATION IN TERMS OF AGENDA AND PRESENTATION ON OUR WEBSITE. NEXT SLIDE. SO, HERE ARE JUST SOME HIGH-LEVEL FINDINGS. THERE WAS SUCH A RICH DISCUSSION BUT I WANTED TO HIGHLIGHT SOME OF THE KEY FINDINGS. GREG -- GAVE AN AMAZING CONVERSATION THAT AT HCV PEOPLE WERE VERY SUCCESSFUL IN INCLUDING ACTIVELY INJECTING DRUG USERS IN PREAPPROVAL TRIALS. AND THE DATA EMANATING FROM THIS WAS REALLY INFORMATIVE BUT ALSO INSTRUMENTAL FOR ACCESS TO THE TREATMENT. SO THE LESSON HERE IS THAT WE CAN BE SUCCESSFUL WORKING WITH PEOPLE WHO ACTIVELY INJECT DRUGS IN CLINICAL TRIAL SETTINGS, INCLUDING PRE-MARKETING APPROVAL. AND THE MESSAGE THAT WAS PUT OUT WAS BE BRAVE. DON'T ASSUME YOU CAN'T DO THESE TRIALS. BE BRAVE BUT PLAN CAREFULLY AND PLAN INCLUSIVELY. WE THEN HAD ANOTHER VERY NICE PRESENTATION BY JONATHAN WU (PHONETIC) WHO IS DOING A PSYCHIATRY FELLOWSHIP AT THE GEORGE WASHINGTON UNIVERSITY, AND INCIDENTALLY I CAN'T HELP BUT MENTION WAS ONE OF OUR EARLY MPH INTERNS FROM UC BERKELEY BACK IN 2014. HE TALKED ABOUT WHAT THE PSYCHIATRY FIELD DOES IN TERMS OF IMPLEMENTATION WITHIN COMMUNITIES WHERE THEY GO INTO THE COMMUNITIES AND TO THE INJECTIONS. AND FIND THE PATIENTS AND KEEP THEM ON TREATMENT AND HOW COST-EFFECTIVE THIS IS BEEN, ESPECIALLY WHEN IT COMES TO REDUCING THE NEED FOR HOSPITALIZATION IN THE LESSON HERE IS THAT THE COST BENEFIT GETS BETTER AND BETTER OVER TIME. THE INITIAL INVESTMENT IN ALL OF THIS REALLY PAYS OFF. AND THE MESSAGE TO US IS, LET'S CONSIDER COMMUNITY OUTREACH IMPLEMENTATION MODEL TO -- -- BECAUSE THERE IS SUCH AN OVERLAP BETWEEN PEOPLE WITH HIV AND PEOPLE WITH PSYCHOSIS. NEXT SLIDE. ANOTHER SET OF FINDINGS WAS THE PATIENT PERSPECTIVE. THEY DESCRIBED THESE LONG-ACTING THERAPIES AS (INDISCERNIBLE) -- THIS IS FROM A DIFFERENT VERSION AND AGAIN WE SHOULD NOT GROUP ALL PATIENTS INTO ONE GROUP. THERE ARE MANY REASONS WHY PEOPLE PREFER LONG-ACTING, IS DIVERSE AND DIFFERENT AS PATIENTS OR ANY OTHER MESSAGE THAT IS CLEAR COME TO IS THAT INVESTIGATORS NEED TO RESPECT THE COMMUNITIES THEY ARE SERVING AND I WILL ECHO WHAT -- THERE'S A TYPO-- REAL OR PERCEIVED THREATS AND WE NEED TO UNDERSTAND THEM IN WHICH THESE POPULATIONS OPERATE AND PATIENTS NEED TO BE RECOGNIZED IN RESEARCH AND POLICY DISCUSSIONS. WE HEARD YOU HAVE TO SEE US I AM. WE HAVE TO RECOGNIZE THEM IN THE FULL DIVERSITY NOT JUST ASSUME THEY ARE ALL ONE CATEGORY OF PEOPLE. AND THE MESSAGE HERE IS THAT LONG-ACTING ART SHOULD BE AVAILABLE TO ALL AND AGAIN WE NEED TO SUBSTANTIATE THAT WITH THE APPROPRIATE EVIDENCE. NEXT SLIDE. WE TALKED ABOUT RESEARCH OPPORTUNITIES IN RURAL AMERICA AND AS I MENTIONED, IT WAS MONICA AND KIM THEY CAME TO US ON BEHALF OF THE ACTG, CLINICAL TRIALS NETWORK AND WANT TO TAKE THE TIME TO CONGRATULATE MONICA ON THE WARD 86 PILOT PROGRAM AND TAKE THE TIME TO ALSO REALLY APPRECIATE THE PRESS RELEASE THAT CAME OUT AFTER HER PRESENTATION ON THIS PROGRAM WITH MANY DIFFERENT INSTITUTIONS, AND DIVISIONS OF THE NIH PARTICIPATING IN COMMENTARY THERE. IT WAS A WONDERFUL PRESS RELEASE. BUT WHAT WE HAVE IN THESE RULE SETTINGS AND SALLY HOTTERS (PHONETIC) REMARK SPECIFICALLY ABOUT WEST VIRGINIA, HOTSPOTS FOR HIV INCIDENCE BUT REALLY SUCH A PAUCITY OF CLINICAL TRIALS AND USING THE NIH FUNDED -- THIS IS AN OPPORTUNITY I THINK FOR ALL OF US TO THINK ACROSS THE NIH AND WHAT IS BEING FUNDED-- IS THE IDEA STATES AND PUERTO RICO PROGRAM, AN OPPORTUNITY FOR RESEARCH WERE RESEARCH CAPACITIES BEING BUILT OUT AND THEY HAD A GREAT CONTRIBUTIONS TO THE COVID RESEARCH AND TREATMENT AND DIAGNOSIS AND VACCINES. AND SO THE LESSON HERE FOR US IS, RURAL OR NONTRADITIONAL RESEARCH SUBJECTS HAVE CAPACITY, PATIENTS AND RESOURCES AND WE SHOULD NOT BE AFRAID TO CONSIDER SOME OF THESE ASIDES ARE BOTH PUBLIC AND PRIVATELY FUNDED HIV RESEARCH. NEXT SLIDE. AND THEN, KIND OF GETTING INTO THE REGULATORY ISSUES HERE, BEFORE APPROVAL WE ALL ACCEPT THE CLINICAL RESEARCH OBJECTIVE IS TO GET THE DRUGS APPROVED AS EFFICIENTLY AS POSSIBLE TO ENSURE ACCESS TO THE NEW THERAPY IS POSSIBLE. AND WITHOUT FDA APPROVAL THE DRUG IS NOT REALLY ACCESSIBLE TO ANYONE. SO WE NEED THAT. BUT THE DIRECT LABEL, THE INDICATION FOR USE, WILL BE BASED ON THE DATA SUBMITTED BY THE SPONSOR TO THE AGENCY. AND IF YOU WANT TO CHANGE THIS INDICATION, THAT WOULD GENERALLY REQUIRE RANDOMIZED TRIALS, IN THE DATA SUBMITTED BY THE SPONSOR TO THE FDA AND I WANT TO POINT OUT THAT FOR CABENUVA WE HAD A VERY SPECIFIC INDICATION REGARDING THE -- SUPPRESSION SO IT BECOMES BOUNCER WORKING ON THE CENTER TRIAL SIZE, AND GETTING THE DRUG APPROVAL AS EFFICIENTLY AS POSSIBLE BUT NOT FORGETTING WHAT I CALL THE "ADHERENCE CHALLENGE" PATIENT EARLY IN THE PROCESS AND REALLY PLANNING ON HOW WE ARE GOING TO MEET THEIR NEEDS. AND THERE ARE MANY OPTIONS FOR LATE STAGE OR SOME OPTIONS FOR LATE STAGE OR PREAPPROVAL TRIAL DESIGN, SUCH AS IMMEDIATE VS. DELAYED START. AND WHEN WE GO TO THE NEXT SLIDE, WE CAN TALK ABOUT OTHER SOURCES OF EVIDENCE FOR EFFICACY AS WELL. AND I'M NOT GOING TO GO INTO ALL OF THESE IN GREAT DETAIL. BUT WE HAD VERY RICH DISCUSSIONS ON HOW TO DO STUDIES IN COMMUNITIES OUTSIDE OF THE MAIN CENTERS, EITHER DURING THE PREAPPROVAL PROCESS OR ESPECIALLY PLANNING FOR THIS AROUND THE TIME OF APPROVAL AND GOING FORWARD. AND ONE THING THAT REALLY CAME OUT TOO, IS THAT WE KNOW THE DRUGS WERE. WE KNOW THE EFFICACY. WE DEMONSTRATED THAT. BUT BUT WE REALLY WANTED IN SOME OF THESE PREPARATIONS IS TO LAY TO REST ANY CONCERNS ABOUT SPECIFIC SAFETY ISSUES. AND SO WE CAN ALSO THINK ABOUT DOING SAFETY MONITORING, SINGLEARM STUDIES FOR EXAMPLE THE FOCUS JUST ON THE SAFETY IN TERMS OF DRUG INTERACTIONS DURING PREGNANCY, COMORBIDITIES AND ISSUES LIKE DRUG RESISTANCE THAT MAY ARISE. NEXT SLIDE. AND THEN ANOTHER SET OF FINDINGS WAS THAT WE DO HAVE APPROVAL OPPORTUNITIES ONCE THE DRUGS APPROVED THERE IS A COLLABORATIVE NETWORK AND THERE ARE INVESTIGATOR INITIATED STUDY FOR WE CAN THINK ABOUT THIS IS WHERE SOME OF THE RULES SETTINGS REALLY COULD PLAY A BIG ROLE. DOING AND EFFICACY STUDY THAT RULES AND CONDITIONS STUDIES WE HAVE EFFICACY AND EFFECTIVENESS TOO AT THE SAME TIME AND WE CAN USE HUB AND SPOKE MODELS. AND ONE AREA THAT HAS BEEN UNEXPLORED THUS FAR IN HIV IS THE USE OF REAL-WORLD DATA AND HOW WE BRING THAT AS REAL-WORLD EVIDENCE OF THE FORTH. NEXT SLIDE. SO IN CONCLUSION WITH ALL OF THESE, THE CHANGING OF THE DRUG LABEL OR INDICATION NOT THE ONLY PATH TO INCREASE SUCCESS. THE ROLE OF TREATMENT GUIDELINES IS VERY SIGNIFICANT IN FACILITATING REIMBURSEMENT AND -- WILL BE TALKING ABOUT THE HIV GUIDELINES PANEL THAT IS SUPPORTED BY NIH, AND HAS PLAYED SUCH AN AMAZING ROLE IN OUR HIV HISTORY IN THIS COUNTRY. AND THAT THE GUIDELINE PANELS LOOK AT THE TOTALITY OF EVIDENCE FROM DIFFERENT SOURCES. WHEREAS THE FDA-- THE LABEL-- IS REALLY JUST THE DATA THAT IS PRESENTED TO THE FDA BY THE SPONSOR FOR THE INITIAL APPROVAL. NEXT SLIDE. SOME KEY TAKE-HOME POINT IS THAT IT IS POSSIBLE TO ENGAGE HARD-TO-REACH INDIVIDUALS IN ART WITH HIGH LEVELS OF SUCCESS. WE HAVE THEACTG 5359, THE PILOT STUDY LED BY MONICA GANDY ON WARD 86. AND AGAIN CONGRATULATIONS MONICA FOR ALL YOUR WORK IN THIS AREA. WE ARE CONCERNED ABOUT SAFETY, IN TERMS OF POPULATIONS. FOR EXAMPLE THE POSSIBILITY OF DRUG RESISTANCE BUT AT THE SAME TIME WE NEED TO THINK ABOUT THE UNMET MEDICAL NEED OF PEOPLE WHO ARE AT THE END OF ORAL TREATMENT OPTIONS. IN THAT SITUATION, LONG-ACTING ART COULD BE LIFE SAVING FOR THEM AND ALSO CABENUVA IS THE FIRST ITERATION OF LA ART, AND SUBSEQUENT THERAPIES WILL BECOME EASIER ESPECIALLY THEY HAVE LONGER PERIODS OF ACTIVITY, SO THAT MAYBE THE INJECTION WILL ONLY HAVE TO BE DONE EVERY FOUR MONTHS OR EVERY SIX MONTHS. OR THE IMPLANT OR THE PATCH OR WHATEVER THE ADMINISTRATION METHOD IS. NEXT SLIDE. SOME GENERAL ACCOMMODATIONS. WE AS A COMMUNITY WORK COLLABORATIVELY TO GENERATE USEFUL DATA FOR BOTH TREATMENT GUIDELINE PANELS AND FOR THE REGULATORY AUTHORITIES. WE SHOULD FOCUS ON EFFICACY AND SAFETY. AND REALLY TO PUT ALL OPTIONS ON THE TABLE. LET'S WORK MULTIPLE AVENUES FOR DATA LET'S FIND THE BEST USE FOR INDUSTRY SPONSORED TRIALS, AND ACADEMIC LED CLINICAL RESEARCH. LET'S ALSO THINK ABOUT WHAT ARE THE UNIQUE CONTRIBUTIONS THAT OTHER COMMUNITIES COULD BRING? AND MARINE, ONE OF YOUR COMMENTS AT THE MEETING AND THANK YOU SO MUCH AGAIN FOR ATTENDING A WORKSHOP, WAS THAT WE NEED TO ALSO THINK ABOUT BRINGING TO RESEARCH OTHER ECONOMIC CENTERS INTO THE COMMUNITIES AND THAT THIS REFLECTED WHAT YOU KEEP HEARING ON YOUR LISTENING TOURS. AND I THINK IT WILL BRING DATA FROM DIFFERENT SOURCES TO CONSISTENCY IN THE DATA OUTCOMES WILL REALLY INCREASE THE CONFIDENCE IN FINDINGS IS REMOVED FROM THESE HIGHLY CONTROLLED RANDOMIZED CLINICAL TRIALS AT THE BEGINNING OF THE DRUG DEVELOPMENT PATHWAY, TO THE IMPLEMENTATION PROGRAMS, AND THE USE OF THESE DRUGS IN REAL-WORLD SETTINGS. NEXT SLIDE. LET'S REMEMBER THAT WE NEED TO APPLY THE COMBINATION APPROACH NOT JUST THE DIRECT REGIMENT BUT ALSO A DRUG MEASUREMENT PLUS A BEHAVIORAL SUPPORT. AND WE NEED TO BRING OLD PLAYERS TO THE TABLE. WE HAD A VERY GOOD GROUP AND WE NOTICE THAT OKAY WE WERE MISSING A COUPLE OF ORGANIZATIONS AND STAKEHOLDER GROUPS FOR CONTINUING DISCUSSIONS; WE WOULD LIKE TO BRING IN THE VETERANS ADMINISTRATION AND INDIAN HEALTH SERVICE, AND THINK ABOUT REPRESENTATIONS FROM ADOLESCENTS AND THEIR SPECIFIC NEEDS AND FOR MORE EFFICIENT RECRUITMENT INTO THESE TRIALS. WE SHOULD DEFINITELY CONSIDER EUROPEAN COLLABORATORS. NEXT SLIDE. LET'S LEARN FROM THE PROOF OF CONCEPT THAT WE DO HAVE DEFINED IMPLEMENTABLE OPTIONS. FOR EXAMPLE MONEY BECAUSE YOU REALLY OUTLINE THIS. THE AMOUNT OF INVESTMENT YOU HAVE MADE INTO THIS PROGRAM AND SUPPORT IS AVAILABLE TO THE PATIENTS AND THE CLINIC STAFF. HOW WILL WE IMPLEMENT THIS ON A LARGE SCALE? HIS HOME TESTING SUFFICIENT FOR THIS PURPOSE? IS QUALITATIVE TEST EFFICIENT? CAN WE USE RETAIL PHARMACIES AND WE SHOULD CONSIDER LOWER INCOME COUNTRIES. AND THAT IS IT SO I WANTED TO HIGHLIGHT OUR WORKSHOP GOALS TO BRING IT BACK UP TO THE TOTALITY OF WHAT WE ARE TALKING ABOUT. I WANT TO THANK THE HIV FORUM SPONSORS AND THANK YOU FOR YOUR ATTENTION. >>CHAIR TOLBERT: THANK YOU DR. MILLER FOR THE PRESENTATION. WE ARE TIGHT ON TIME AND I WANT TO ACKNOWLEDGE OUR NEXT SPEAKER, WHO IS A DIRECTOR OF ARPAH. WANT TO USE MY CHAIR DISCRETION HERE TO TRY TO GET TO A COUPLE OF COMMENTS BEFORE WE MOVE ON TO THE NEXT PART OF THE AGENDA. >>I WANT TO MAKE A QUICK COMMENT MINDFUL OF TIME. I WANT TO THANK THE SPEAKERS FOR AN OUTSTANDING PRESENTATION AND I THINK THE MAIN ISSUE HERE AS YOU POINTED OUT IN YOUR SLIDE PARTICULARLY SLIDE 18, IS THE MESSAGING. AND THE FACT THAT WE ARE GOING TO GET A LOT OF CONFUSION PUSHBACK MOSTLY BY PROVIDERS BUT TO A LESSER EXTENT BY THE COMMUNITY. AND I THINK WHAT WOULD BE REALLY WISE FOR US IS TO THINK OFF LINE WITH ROHAN'S INPUT, PROVIDE INFORMATION OUTSIDE OF THE GUIDELINES AND WEBSITES, AND A TOUR OF FORCE AND ENGAGE PAF, ENDORSES CHANGE AND PROVIDE SOME GRANULARITY ON PROTOCOLS FOR MONITORING VIRAL LOAD, AND WHAT TO DO THE CASE OF MASTITIS, AND HOW DO WE WEAN. THE KINDS OF QUESTION THAT FAMILIES WITH HIV AND PROVIDERS ARE GOING TO HAVE. THIS IS THE START OF THE KICKOFF AND THEN WE CAN REALLY GET THIS ON THE ROAD AND PROVIDE SUPPORT ACROSS COUNTRY FOR THIS. >>CHAIR TOLBERT; ALL RIGHT THANK YOU DR. SLEASMAN. WE WILL GO TO DR. TURNBUL NEXT. >>I AGREE HUNDRED PERCENT WITH DR. SLEASMAN AND HIS ASSESSMENT PARTICULARLY AROUND THE GARLANDS AND THERE HAS BEEN A LOT OF CHATTER AROUND THIS CALLOUS PARTICULARLY IN THE COMMUNITIES, BUT NOBODY IS REALLY QUITE SURE WHAT IS, AND REALLY MAKING INFORMED CONSENT AND I WHOLEHEARTEDLY AGREE, HOW WE GET THIS INFORMATION OUT THERE NOT ONLY TO THE PROVIDERS BUT TO THE WOMEN AS WELL AND THAT IS THE FIRST THING. THE SECOND THING IS I WANT TO SAY THANK YOU TO DR. MILLER FOR YOUR PRESENTATION. MY QUESTION TO YOU WOULD BE, HAVE YOU LOOKED AT, OR DISCUSSED, OR EVEN THOUGHT ABOUT -- LIKE THE SUCCESS OR NON-SUCCESS OF ESTABLISHING CLINICAL TRIAL PRACTICES WITHIN THE COMMUNITIES. NUMBER ONE. AND IN TERMS OF ENGAGING PERSONS WITH LIVED EXPERIENCE, IN THE ACTUAL DEVELOPMENT AND CREATION OF THE RESEARCH STUDIES, WHEN WE TALK ABOUT INCLUSION THAT IS WHAT I THINK ABOUT. IF YOU COULD RESPOND TO THAT DR. MILLER THAT WILL BE HELPFUL. >>DR. MILLER: THANK YOU SO MUCH DR. TURNBULL. GOOD TO SEE YOU GET AN ABSOLUTELY I AM SORRY IT DID NOT COME THROUGH MORE CLEARLY. ABSOLUTELY THE LIVED EXPERIENCE NEEDS TO BE A ON THE TABLE, AT THE TABLE AS WE RECOGNIZE AND WORK WHEN WE SEE THE PEOPLE THAT WE ARE TRYING TO SERVE AND THAT IS ABSOLUTELY THE CASE. WE HAD SOME REPRESENTATION AT THE MEETING BUT OBVIOUSLY, AGAIN, IT IS SUCH A DIVERSITY AND FULL JOY THAT WE NEED TO RECOGNIZE AND NOT JUST KIND OF FOCUS ON ONE OR TWO CATEGORIES OF PATIENTS. >>THANK YOU. >>CHAIR TOLBERT: THANK YOU DR. MILLER. DR. MHETA AND GANDI I WILL CIRCLE BACK TO YOU AFTER THE GUARD REPRESENTATIONS AND I WANT TO KEEP US ON SCHEDULE BECAUSE WE DO HAVE ADDITIONAL GUESTS. SO I'M GOING TO GO AHEAD AND PROCEED AND INTRODUCE OUR NEXT PRESENTERRENEE WEGRZYN, PHD, DIRECTOR, ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H) . PREVIOUSLY SERVED AS VICE PRESIDENT OF GINKGO BY WORKING HEALTH INNOVATION AT CONCENTRIC -- WHICH HE FOCUS AND APPLY THE TOOLS OF SYNTHETIC BIOLOGY TO OUTPACE INFECTIOUS DISEASES. SHE COMES TO ARPAH WITH EXPERIENCED WORKING FOR OVER A DECADE OF THE DEFENSE ADVANCED RESEARCH PROJECTS, DARPA. FIVE OF THOSE YEARS AS A PROGRAM MANAGER WITH A $250 MILLION FOLIO, AND IS A TECHNICAL ADVISOR TO THE INTELLIGENCE ADVANCED RESEARCH PROJECT ACTIVITY DR. WEGRZYN LEVERAGE THE TOOLS OF-- TO SUPPORT THE DOMESTIC OF BIO ECONOMY AND STORED BY THREATS WE ARE VERY PLEASED TO HAVE DR. WEGRZYN WITH US TODAY AND I WILL HAND IT OVER TO YOU. >>DR. WERGZYN: THANK YOU APPRECIATE THE INVITATION TO PARTICIPATE AND I AM EXCITED TO SHARE WITH YOU LITTLE ABOUT ARPAH THE NEW FEDERAL AGENCY THAT STARTED AT LAB THE END OF LAST YEAR AND I WANT YOU TO THE MISSION OF PROGRESS WAS MADE BUT MORE IMPORTANTLY OUR BUSINESS MODEL. AS WE GROW YOU CAN UNDERSTAND WHAT ARE THE BEST WAYS TO WORK WITH ARPAH SINCE THIS IS BRAND-NEW TO THE HEALTH ECOSYSTEM. NEXT SLIDE. SO VERY IMPORTANTLY, OUR MISSION IS SIMPLY PUT TO ACCELERATE BETTER HEALTH OUTCOMES FOR EVERYONE. WE MEASURE OUR SUCCESS IN TERMS OF HEALTH OUTCOMES SO WE LOVE THE ACADEMIC RESEARCH BUT WE ARE NOT INTERESTED IN A LOT OF PUBLICATIONS FOR SCIENCE WE WANT TO PUT TOOLS IN THE HANDS OF AMERICANS THAT ARE GOING TO IMPROVE THEIR HEALTH MOVING FORWARD AND IMPROVE THE HEALTH OF EVERYONE AND YOU WILL SEE AS WE TALK ABOUT OUR ORGANIZATION HOW WE ARE TRYING TO INCLUDE EQUITY AND DIVERSITY IN EVERYTHING WE DO IN THE DESIGN OF OUR PROGRAMS. NEXT SLIDE. SO AS IT WAS MENTIONED IN THE INTRODUCTION THIS IS PRESIDENT BIDEN'S VISION, TO BE IN AN ORGANIZATION SO AUDACIOUS THAT WE CAN TRY IDEAS THAT BREAK THE MOLD AND GET ALL OF THE THINGS IN A GOVERNMENT AGENCY IN ONE PLACE OF THE CONTRACT AND SHOP, OUR LEGAL TEAM AND ARE A TEAM AND THE BUDGETING SO WE CAN START TO BRING THE TECHNICAL LEADERS TO LAUNCH PROGRAMS TO DO JUST WHAT THE PRESIDENT CALLED US ON TO DO. I WILL SPEND A LITTLE BIT OF TIME ON THE SLIDE BECAUSE IT IS IMPORTANT TO UNDERSTAND HOW WE ARE DIFFERENT THAN THE REST OF THE HEALTHCARE ECOSYSTEM. WE ARE HERE TO CATALYZE THE ENTIRE ECOSYSTEM AND WE HAVE A FEW SPECIAL AUTHORITIES THAT CONGRESS HAS GIVEN US AND THE PRESIDENT HAS SIGNED INTO LAW THAT MAKES THIS POSSIBLE. HERE I AM THE ARPAH DIRECTOR AND I REPORT DIRECTLY TO SEC. BECERRA. A LOT OF THE DECISION-MAKING THAT I'M GOING TO DO IS DONE IN THE CAPACITY OF HHS INDEPENDENT OF NIH WE ARE NOT AN INCIDENT WITHIN NIH. WE ARE AN INDEPENDENT AGENCY BUT BEING BUILT INSIDE OF NIH WHAT THAT HELPS US DO IS FROM THE ONE WE WERE ABLE TO HIT THE GROUND RUNNING. HAVE PAYROLL AND WE DID NOT NEED TO HAVE STAFF TO DO THAT, GETTING ALL OF OUR IT EQUIPMENT AND ALL OF THE THINGS THAT YOU NEED TO BE A GOVERNMENT EMPLOYEE, INCLUDING HEALTHCARE BENEFITS ETC. THEY WERE ABLE TO HELP US WITH AND NOW AS WE TRANSITION INTO THE MORE TECHNICAL WORK THAT I WILL TALK A LITTLE BIT ABOUT, WE ARE RIGHT ADJACENT TO SUBJECT MATTER EXPERTS CAN HELP US DESIGN OUR PROGRAMS EVEN IF THE PROGRAM MANAGER IS THE SOLE DECISION-MAKER. THERE IS AN IMPORTANT DIFFERENTIATOR. AT ARPAH WE DID NOT DESIGN ON THE PROGRAM TO WORK ON THROUGH THE PROJECT SESSION BUT WE WOULD DECIDE TO FUND THE PROPOSAL AND HELP SHAPE WHAT THE PROPOSAL AND THE WORK LOOKS LIKE. WE WON'T BE ISSUING ANY GRANTS. THIS WILL BE COOPERATIVE AGREEMENTS, CONTRACTS AND OTHER TRANSACTIONAL AUTHORITIES FOR THOSE AFICIONADOS IN THE ACQUISITION AND THE FEDERAL GOVERNMENT. CONGRESS INITIALLY GIVES $1 BILLION TO START. WITH RECENT APPROPRIATIONS WE HAVE 1.5 BILLION NOT LINKED TO ANY SINGLE DISEASE THESE ARE OPEN DOLLARS MEANT TO BE A PLACE FOR PROGRAM MANAGERS TO COME IN WITH THE BIG IDEA THAT THEY WANT TO SOLVE IN ANY CAPACITY. MAYBE IT IS A CANCER MOONSHOT SPECIFIC PROGRAM. IT COULD BE SOMETHING COMPLETELY DIFFERENT, NEUROSCIENCE FOCUSED, HIV-FOCUSED OR DEVELOPING NEW DEVICE. ALL OF THOSE ARE WITHIN THE SCOPE AND WE HAVE THAT FREEDOM TO TRANSACT, BY RISK AND SHOW THAT SOMETHING IS POSSIBLE WE ARE A PLACE, THAT NO HIGHER RISK TYPE OF PROJECT WILL BE ABLE TO BE PURSUED THAT IS A ROLE HERE. WE DO NOT HAVE INTERNAL RESEARCH LABS, THIS IS STRICTLY A FUNDING AGENCY, EXTRAMURAL RESEARCH. ON OTHER INTERESTING PART OF HOW WE ARE BUILT IS THE CONGRESS HAS CAPPED US AT 210 EMPLOYEES WE HAVE A VERY FLEXIBLE AND ADAPTABLE WORKFORCE AND IS A PROJECT MANAGER LAUNCHES THE PROGRAM ON GENE EDITING THAT CAN AUGMENT A TEAM OF CONTRACTORS TO SUPPORT THE WORK IN THE TEAM MAY LEAVE THE ORGANIZATION WHEN ANOTHER PROGRAM MANAGER COMES IN WHO HAS A NEUROSURGERY PROGRAM TO BE A COMPLETELY DIFFERENT SKILL SET. AND IN THIS WAY WE ARE REALLY BEING ABLE TO BE FLEXIBLE AND RELEVANT AND ADAPTABLE WITH OUR WORKFORCE AND WITH THAT WE WOULD NOT BE ABLE TO DO IN A STRUCTURE. GOING TO THE NEXT SLIDE. THIS IS OUR ECOSYSTEM SO YOU ARE ALL PART OF OUR ECOSYSTEM ARE STAKEHOLDERS AT NIH, TO MAKE SURE THAT OUR TRANSITIONAL PARTNERS AND THE PRIVATE INVESTORS ARE AWARE OF US AND HELP INFORM THE PROGRAM DESIGNED TO ENSURE THE TRANSITION. WE DO NOT WANT TO CREATE A CLIFF AT THE BACK END, WE WANT ALL THESE INNOVATIONS TO EXIST IN THE REAL WORLD AND TO SERVE OUR CUSTOMERS IN ALL OF THE ARPAS, WE HAVE THE LARGEST CUSTOMER BASE IN THE MOST DIVERSE CUSTOMER BASE, THE AMERICAN PEOPLE AND THE PUBLIC AND PATIENT GROUPS AND OUR PERFORMERS, THESE ARE THE FOLKS WE FOUND A PREDOMINANTLY FROM ACADEMIA AND FROM INDUSTRY AND BUSINESS OR TEAMS THAT ARE BUILT OR ARE A BLEND OF THE TWO SOMETHING THAT WE ANTICIPATE WILL HAPPEN VERY COMMONLY. NEXT SLIDE. WHAT THIS ALL CREATE IS WHAT WE LIKE TO THINK ABOUT AS A FLYWHEEL OF PROGRAMS AND PROGRAM MANAGERS AND PROGRAM MANAGERS HAVE A TERM APPOINTMENT THREE YEARS. THEY CAN STAY UP TO AN ADDITIONAL THREE YEARS FOR A TOTAL OF SIX AND THEN THEY WILL LEAVE THE ORGANIZATION. WE ASKED HIM TO TAKE A RISK ON AS. WE GIVEN THE OPPORTUNITY TO GET A BIG BACK AND COUNT, TYPICALLY $50-$150 MILLION DOLLAR PROGRAMS AND WE OFFER A COMPETITIVE SALARY, OUTSIDE OF THE GS SCALE. WE ARE NOT GOING TO REQUIRE ANYBODY TO MOVE SO THAT IS ONE BENEFIT OF A POST-COVID ENVIRONMENT AND WE HAVE PROGRAM MANAGERS ALL OVER THE COUNTRY AND IT WILL BE BUSY TRAVELING. THEY ARE GOING TO BE ENGAGING WITH PATIENTS AND CUSTOMERS WITH LIVED EXPERIENCES. THEY WILL BE WORKING WITH THE BEST AND BRIGHTEST THAT UNIVERSITIES AND HOSPITALS ALL OVER THE COUNTRY. AND SO ONE FINAL POINT IF YOU LOOK AT ARPA-H I HOPE TO HIRE 20 PROGRAM MANAGERS THIS YEAR AND IF YOU LOOK AT ADDITION YOU WILL SEE 20 TOTAL PROJECT IN TWO YEARS FROM NOW IT WILL BE COMPLETELY DIFFERENT COLLECTION OF PROGRAMS AND PROJECTS BECAUSE WE ARE GOING TO HAVE NEW PROGRAM MANAGERS, AND THE OTHER PROGRAMS WILL BE GRADUATING. IN THIS WAY WE ARE ABLE TO SERVE THE ENTIRE ECOSYSTEM. NEXT SLIDE. I THINK IT IS HELPFUL, ONE OF THE MOST IMPORTANT THINGS THAT I CAN DO AND I THINK WHAT THE PRESIDENT CALLED ON ME WAS TO BRING THE ARPA ATTITUDE AND CULTURE TO ARPA-H. AND THESE ARE SOME OF THE ORGANIZATIONAL ATTRIBUTES WE TREASURE AND PROTECT. ONE IS THAT THE PROGRAM MANAGERS ARE THE NUCLEUS OF OUR ORGANIZATION. SO WE REALLY HOLD SACRED THE ABILITY TO MANAGE HIS PROGRAMS INDEPENDENTLY SO WE CAN TAKE THIS RISK. AND I CONSIDER MYSELF A SOMEBODY WHO WORKS FOR THIS PROGRAM MANAGERS AND GOES TO THE HILL AND BLOCKS AND TACKLES AND MAKE SURE WE HAVE THOSE FREEDOMS BECAUSE WE WANT TO CREATE THE INLET AND GPS THE SAME WAY ARPA DID BUT FOR HEALTH. WE SEE THE FUTURE OF RADICAL CHANGE TO ITERATIVE PROJECT, BRUTE FORCE PROJECT NEED NOT APPLY. AUTONOMY IS KEY AS WELL. YOU ALREADY SEE THE STRUCTURES THAT WE HAVE IN REPORTING UP A DIFFERENT HIERARCHY CHAIN. ARE PROGRAM MANAGERS ONCE THEY GET THE BANK ACCOUNT IT REALLY IS UP TO THEM TO PICK THE TEAM OF PERFORMERS AND SOLVERS THAT WILL WORK TO SOLVE THE PROBLEM. I WILL TALK A LITTLE BIT ABOUT PROGRAM STRUCTURE IN JUST A MOMENT. AND FINALLY, I MENTIONED TERM LIMITS. I AM TERM LIMITED AS THE PROGRAM MANAGERS ARE SO WE HAVE A SENSE OF URGENCY WHEN WE ARRIVE. WE KNOW THIS IS AN INCREDIBLE OPPORTUNITY TO MAKE A DIFFERENCE AND WE ARE GOING TO MAKE EVERY MINUTE COUNT. NEXT SLIDE. THE NEXT FEW SLIDES I'M GOING TO WALK YOU THROUGH WHAT DOES THIS MODEL LOOK LIKE? SO RIGHT NOW, WITH THE PROGRAM MANAGERS ARRIVE BEFORE SOMEBODY COMES ON BOARD, WE LIKE TO SAY PROGRAM MANAGERS THINK LIKE CEOS AND THE COOS OF THE PROGRAM AND BECOME TO ARPA-H WITH CLEARLY ARTICULATE A PROBLEM IN HEALTHY WANT TO SOLVE SO IT IS A COMMISSION OF THE TWO THINGS WE HIGHER ON. AND THEN BRING A PROGRAM MANAGER IN. IT TAKES ABOUT THREE OR FOUR MONTHS TO WRAP UP A SOLICITATION, TALK TO THE STAKEHOLDERS THAT WILL BE KEY PLAYERS HERE, AND THEN LAUNCH THOSE PROGRAMS, WANT TO SOLICITATION HAS A PROPOSALS THE PROGRAM MANAGER WILL SELECT THE PERFORMERS OR TEAMS THAT WILL BE THE SOLVERS TO ADDRESS THAT CHALLENGE MOVING FORWARD. NEXT SLIDE. THIS IS REALLY A MODEL FOR THE PROGRAM MANAGER IS A LOT OF CONTACT WITH PERFORMERS. THIS IS WHY WE DON'T USE A GRANT SPACE, ACQUISITION SYSTEM WE USE CONTRACTS AND COOPERATIVE AGREEMENTS BECAUSE WE HAVE A SEAT AT THE TABLE WE WANT ALL OF OUR TEAM TO BE SUCCESSFUL BUT WE KNOW THERE'S A RISKY SOME OF THEM WILL NOT BE SUCCESSFUL. BY BEING VERY CLOSE TO THE WORK WE CAN IDENTIFY THOSE THAT ARE NOT BEEN SUCCESSFUL AND WE CAN DOUBLE DOWN WE CAN HELP THEM ACCELERATE AND GRADUATED FOR THOSE EFFORTS THAT MAYBE ARE NOT QUITE AS SUCCESSFUL IT IS RESPONSIBILITY OF THE PROGRAM MANAGER TO PIVOT AND DIVERT RESOURCES TO OTHER SOURCES SO WE WILL HAVE A VERY WELL RESOURCED PROGRAMS BUT WE HAVE A GOAL IN MIND. WE ARE GOING TO BE REALLY FOCUSED ON ACHIEVING THAT GOAL. THESE PROGRAM MANAGERS HAVE A REALLY IMPORTANT RESPONSIBILITY AND BEING A STEWARD OF TAXPAYER DOLLARS. I WILL TELL YOU TO A LITTLE BIT ABOUT THE NEW OFFICE IN CAPABILITY THAT WE ARE SETTING UP BECAUSE THIS IS SO CRITICAL IN CONSCIENCE WITH DARPA, MANY OTHER PROGRAMS LIKE THE DEPARTMENT OF DEFENSE TO BE IN ADVANCED DEVELOPER AND TAKE THE CAPABILITIES ALL THE WAY TO COMPLETE TECHNOLOGY READINESS. THAT DOES NOT EXIST IN THE HEALTH SECTOR SO WE REALLY RELY SO MUCH ON THE PRIVATE SECTOR TO BE ABLE TO HELP US TRANSITION PROJECTS. AND ON THE I WILL WALK YOU THROUGH HOW DOES THE PROGRAM MANAGER DO THIS? AND SO WE HAVE ADOPTED AT ARPA-H WHAT ARE CALLED THE HEIMEYER QUESTIONS (PHONETIC), STARTED BY DIRECTOR HEILMEYER. WHAT ARE YOU TRYING TO DO? WHAT HEALTH PROBABLY TRYING TO SOLVE? WHAT IS A NEW APPROACH? WHAT IS THE COMPANY THAT YOU KNOW ABOUT THAT YOU KNOW WILL BE A GAME CHANGER TO REALLY SOLVE THIS PROBLEM AND WANT TO GIVE IT A SHOT? WHAT ARE THE RISKS? WHAT WILL PREVENT US FROM REACHING OUR OBJECTIVE? HOW LONG WILL IT TAKE? HOW MUCH WILL IT COST? AND MOST OF THESE PROJECTS THAT WE WILL PURSUE PROBABLY WILL HAVE SOMETHING ON THE LINE OF 5, 10, 15 YEARS UNTIL WE KNOW IF IT IS SUCCESSFUL OR NOT MAYBE THAT IS HOW LONG IT TAKES TO GET TO THE CLINIC AND THAT'S OKAY BECAUSE WE NEED TO HAVE MEASURES FOR INTERIM SUCCESS, SO WE KNOW THAT WE ARE MOVING ALONG AND HAVE GO, NO GO DECISIONS AND DE-RISKING THIS FOR THE REST OF OUR ECOSYSTEM TO TRANSITION TO. WE'VE ADDED TWO ADDITIONAL QUESTIONS AT ARPA-H. ONE IS TO ENSURE EQUITABLE ACCESS FOR ALL PEOPLE. EVERY PROGRAM MANAGER BEFORE WE GIVE THEM THE BANK ACCOUNT HAS TO SHARE HOW THEY WILL ADDRESS ACCESSIBILITY, CAUSE AND ALSO USER EXPERIENCE. WE WANT TO MAKE SURE WE ARE CREATING TOOLS THAT CUSTOMERS AND PEOPLE WILL LIVED EXPERIENCES WILL ACTUALLY BENEFIT FROM. AND FINALLY HOW MIGHT THIS PROGRAM BE MISPERCEIVED OR MISUSED? WE KNOW THERE'S A LOT OF MISINFORMATION ABOUT HEALTH OUT THERE AND WE DO NOT WANT TO BE CONTRIBUTING TO THE PROBLEM. WE WANT TO THINK PROACTIVELY AT THE BEGINNING OF THE PROGRAM TO LIMIT THAT IS MUCH AS POSSIBLE. AND SO ON THE REALLY THE LIFECYCLE. 95% OF WHAT THE PROGRAM MANAGERS GOING TO DO. SOMEWHERE ALONG THE LIFECYCLE IF YOU DO START A NEW PROGRAM SO YOU WILL HAVE MULTIPLE PROGRAMS RUNNING AT ONCE AND IN DIFFERENT STAGES OF THE LIFECYCLE. EVERYTHING FROM DESIGNING A PROGRAM, FOR EXAMPLE IF WE HAD A PROGRAM IN HIV, STAKEHOLDERS LIKE YOU MAKING SURE WE ARE INCLUDING YOUR INSIGHTS AND WHAT IS WORKING AND WHAT IS NOT IN THE COMMUNITY IF WE HAVE A BIG INVESTMENT IN THIS AREA. THIS WILL REALLY CHANGE A STATE-OF-THE-ART. WE NEED TO COLLECT THOSE INSIGHTS ARE AND ALSO UNDERSTAND THE MARKETPLACE. IS OUR MARKET FOR THIS OR NOT? IT'S OKAY IF IT ISN'T THAT WE NEED TO SHIP THAT MARKET AS WE MOVE FORWARD. AND THEN BILLING THE PERFORMANCE TEAMS AND PUTTING OUT THE SOLICITATION AND SELECTED THE TEAM TO DO THE WORK. AND THEN IT IS ACTIVE PROGRAM MANAGER AND BEING THE CEO OF THE PROGRAM AND MAKING SURE THE TEAMS ARE WORKING TOWARDS THEIR GOALS AND HELPING THEM. SOMETIMES IT IS MAKING INTRODUCTIONS, BRINGING IN NEW PLAYERS AS NEEDED. LEARNING AND GROWING. WE ARE GOING TO FAIL SOMETIMES AND IN SOME WAY SUCCESS EARLY ON FOR US IS GOING TO LOOK LIKE FAILURE BECAUSE YOU'RE NOT TAKING BIG ENOUGH RISK BUT WE TRANSPARENT IN PUBLIC ABOUT THESE FAILURES SO THE WHOLE COMMUNITY CAN LEARN FROM THEN WE DON'T HAVE TO REPEAT THOSE MISTAKES AND LEARN FROM THEM. AND COMMERCIALIZATION TRANSITION. THE PROGRAM MEASURES ARE ALSO RESPONSIBLE TO MAKE SURE THE PROGRAM CAN GRADUATE OUT OF THE AGENCY. THE PROGRAM MANAGERS WILL BRING THEIR OWN IDEAS OTHER SPECIFIC PROGRAM THAT THEY WANT TO FOCUS ON BUT I HAVE OUTLINED FOUR INITIAL FOCUS AREAS FOR ARPA-H THAT I BELIEVE FURTHER INVESTMENT CAN CHANGE THE STATE-OF-THE-ART IN THE FIELD. FIRST IS SELF SCIENCE FEATURES EXPANDING WHAT IS TECHNICALLY POSSIBLE. THINK HERE ABOUT THE TOOLS, TECHNOLOGIES AND PLATFORMS. IT IS DISEASE AGNOSTIC BUT YOU MADE DECIDE TO CREATE A NEW CELLULAR MANUFACTURING PROBLEM HE WAS SELECTED TEAM FOCUSED ON CANCER. YOU MAY SELECT OTHER TEAM THAT IS FOCUSED ON ALZHEIMER'S DISEASE. AND HAVE THEM NOT COMPETE AGAINST EACH OTHER. WE LIKE TO THINK OF COOPETITION, WERE BOTH ARE THINKING ON THE SAME GOAL BUT ONE WILL ADVANCE THE STATE-OF-THE-ART. SCALABLE SOLUTIONS IS REACHING EVERYONE CRITICALLY, BRINGING A NEW THERAPY, AND THE SCALE OF REACHING PEOPLE WHERE THEY ARE AT BUT YOU HEARD WHEN THE LAST TALKS ABOUT RURAL SETTINGS. WEST VIRGINIA IS DIFFICULT TO REACH PATIENTS AND WHAT ARE THE NEW CAPABILITIES TO REACH THE SCALE OF EVERYONE WHERE THEY ARE AT? THAT ARE MEANT TO BE THE CUSTOMERS OF THESE PROGRAMS? CO-ACTIVE HEALTH AND KEEPING PATIENTS IN PLACE. AND THE DETECTION PROBLEMS THAT WILL CONTRIBUTE TO THIS GOAL AND FINALLY RESILIENT SYSTEMS. AND HOW TO CREATE A GREATER CAPABILITY WHERE THE SUM IS MORE IMPACTFUL THAN THE PARTS. THIS IS ALSO THE PLACE WHERE THERE ARE MANY LOW HANGING FRUIT, DIGITAL SOLUTIONS IF WE CAN GET SOME OF THOSE TO BE ABLE TO SPEAK TO ONE ANOTHER AND SHARE DATA AND MAKE IT MACHINE-READABLE WE CAN REALLY IMPROVE CARE FOR PATIENTS. NEXT SLIDE. THIS IS REALLY UNIQUE TO ANY ARPA, WE ARE THE FIRST ONE WITH THE PROJECT ACCELERATED TRANSITIONAL OFFICE AND WE DO NOT HAVE ADVANCED DEVELOPERS AND THE FEDERAL GOVERNMENT FOR MOST THINGS COMING OUT OF AN ARPA, SO THAT MEANS WE START TO PRIME THE PUMP FOR TRANSITION RIGHT FROM THE BEGINNING OF THE PROGRAM. UNDERSTANDING HOW DO WE DESIGN THESE PROGRAMS IF SOMEBODY WANTS TO USE THE TOOL TO THE BACK END OF THE PROGRAM, ACCESSING THE MARKETS AND MAKE SURE WE HAVE SOLICITATION THAT IS RELEASED SUCH AS A BAA, TO IDENTIFY PEOPLE WHO MIGHT WANT TO BE FUNDED BY ARPA-H. NOT EVERYBODY KNOWS ABOUT ARPA-H YET. SO IT IS A GOOD GROUP TO BE HERE TODAY TO SHARE A LITTLE BIT MORE ABOUT OUR ORGANIZATION. WE NEED TO MAKE SURE WE HAVE A BROAD REACHING WE DO NOT MISS THE OPPORTUNITY TO WORK WITH A GROUP THAT MIGHT HAVE A REALLY UNIQUE SOLUTION. AND WE ARE GOING TO DO VENTURE CAPITAL STYLE DUE DILIGENCE WHETHER TECHNICAL DILIGENCE, MANAGEMENT DILIGENCE AND WE ARE GOING TO LEAN ON THIS OFFICE TO HELP US DO THAT. WE KNOW THAT IS GOING TO HAPPEN AT THE BACK END OF THESE PROGRAMS ANYWAY SO WE MIGHT AS WELL BE HELPING THESE TEAMS FROM THE VERY BEGINNING AND THEN WE WILL ASSESS PERFORMANC, UNDERSTAND MVPS BEFORE WE ITERATE IN THE WRITTEN SESSION WILL START TO ADOPT A LOT OF THE OTHER TOOLS IN THE FEDERAL TOOLKIT LIKE THE SBARS, ETC., AS WE MOVE FORWARD. SO WE ARE STILL FAIRLY EARLY DAY. I WOULD LIKE TO HIRE 20 PROGRAM MANAGERS THIS YEAR AS I MENTIONED AND WE WILL START TO SEE THE FIRST PROGRAM MANAGERS COMING ON IN THE NEXT FEW WEEKS AND AT WHAT I WOULD ASK YOU AND YOUR COMMUNITY, IF YOU ARE REALLY PASSIONATE ABOUT WHAT YOU DO AND YOU WANT TO SEE ARPA-H WORKING IN THE FIELD, THE BEST THING YOU CAN DO IS THINK ABOUT ONE OR TWO PEOPLE IN YOUR NETWORK-- OR MAYBE IT IS YOU-- THAT WANT TO COME ON AND BE A CHAMPION FOR THIS EFFORT AND SOLVE ONE OF THESE BIG PROBLEMS. SO THESE ARE THE PROGRAM MANAGERS. THEY THINK LIKE CEOS AND THEY ARE DECISIVE. THERE IS AN URGENCY TO THE PROBLEMS THEY NEED TO SOLVE AND NOT AFRAID TO FAIL. THEY ARE VERY CUSTOMER CENTRIC. THEY KNOW THE PROGRAMS BELONG TO ARPA-H AND THEY WANT TO GET IT OUT THERE TO THE AMERICAN PEOPLE AND THIS COULD BE FOLKS IN ALL DIFFERENT STAGES OF THEIR CAREERS. IT COULD BE EARLY-STAGE AND UNBIASED, FRESH WITH IDEAS AND MAYBE MORE MIDDLE CAREER STATUS QUO CHALLENGER. THIS WAS ME. I HAD A BLOCKER, AND SOME OF THE WORK THAT I WAS DOING AND I CAME TO ARPA-H TO GET A BIG BANK ACCOUNT TO TRY TO UNBLOCK AT WHICH WE WERE ABLE TO DO FOR SAFER, MOST EFFECTIVE GENETIC TECHNOLOGIES. AND THEN THE CAREER FOLKS WHO ARE NOT AFRAID TO TAKE RISKS. THIS MIGHT BE THE LAST STOP IN GOVERNMENT BEFORE THE RETIRE. SO THIS IS A GREAT WAY TO HAVE SOMEONE WHO REALLY UNDERSTANDS THE PROBLEM AND TRY TO SOLVE IT. NEXT SLIDE. A COUPLE OF QUICK THINGS ABOUT BECOMING A PROGRAM MANAGER. I MENTIONED THAT IT IS A TERM APPOINTMENT, THREE YEARS WITH AN ADDITIONAL THREE YEARS AND CAN OFFER COMPETITIVE SALARY. IT CAN BE A DIRECT GOVERNMENT HIGHER OR WHAT IS CALLED AN IPA, SO WE CAN BRING FOLKS ON LOAN FROM A UNIVERSITY SO THEY DO NOT LOSE THERE'S LOTS. BUT THEY WILL BE EMPLOYED FOR ARPA-H DURING THEIR TIME HERE AND THAT IS IMPORTANT TO UNDERSTAND THE APPLICATION PROCESS. IS PRETTY SIMPLE BUT IT IS INTENSE. IT STARTS WITH MAKING CONTACT, A COVER LETTER, CV, BUT THE BIG PROBLEM HELP THAT YOU WANT TO SOLVE ARTICULATED THROUGH THE QUESTIONS AND WE WILL HAVE A CONVERSATION WITH YOU. LEARN A LITTLE BIT MORE ABOUT YOU AND WHAT YOU WOULD WANT TO COME TO ARPA-H AND THE CONCEPT THAT YOU WANT TO PURSUE. AND THAT IF IT IS LOOKING GOOD WE WILL HELP YOU SHAPE THE IDEA AND THEN HELP YOU PITCH THE CONCEPT OF YOUR SELECTED INDIVIDUAL HAVE ABOUT 3 TO 4 MONTHS TO LAUNCH THE PROGRAM AND START WORKING IN EARNEST ON THE EFFORT WITH THE TEAMS THAT THEY FUND. LAST, I WANT TO SAY THAT FOR A SUCCESS IS REAL WORLD IMPACT. WE WANT REAL PEOPLE TO WANT TO USE THE TOOLS AND ENTHUSIASTICALLY ADOPT THEM. AND SHOW PROOF OF CONCEPT OR WE CAN TAKE SOMETHING THAT SEEMED IMPOSSIBLE, AND SHOW THEY CAN ACTUALLY BE DONE AND TO DO THIS AGAIN IN AN EQUITABLE WAY FOR OTHER COMMUNITIES THAT NEED THEM AND THE BEST VEHICLES TO NEW THEM OTHER COOPERATIVE AGREEMENTS, CONTEXT ANOTHER TRANSACTIONAL AUTHORITIES. SO A QUICK LOOK AT THE MILESTONES THAT WE PICKED. WE ARE REALLY A STARTUP. AS A STARTUP, WE LAUNCHED OUR WEBSITE ABOUT A MONTH AGO, THE FIRST PROGRAMS WILL COME UP THIS SUMMER AND WE BUILT THE BUSINESS OF THE HOUSE WE ARE EXCITED TO HAVE THE CONTRACTOR TEAM AND THE OTHER COMPONENTS THAT NEED TO BE IN PLACE A PROGRAM MANAGERS TO BE SUCCESSFUL AND WE HAVE OUR FIRST SOLICITATIONS OUT FOR SOME OF THE PATTY OFFICE AND THE PARTNERSHIP AND INTERMEDIARY AGREEMENT FOR TRANSITION AND TRANSITION PROGRAM MANAGERS ON BOARD SO SERIOUSLY TO TAKE THAT. I SPENT A LOT OF MY TIME IN THE FIRST THREE MONTHS WITH CONGRESS, ENJOYING BIPARTISAN SUPPORT IN EVERYBODY IS TOUCHED BY HEALTH AND FRUSTRATED ABOUT HOW LONG IT TAKES TO GET SOLUTIONS FORWARD. THEY REALLY WANT TO HELP US BE SUCCESSFUL AND WE WERE THRILLED BY THE AUTHORITY THEY GAVE US TO HELP US DO THAT. THIS IS A PICTURE OF MYSELF AND THE FDA COMMISSIONER, WE WERE AT J.P. MORGAN EARLIER THIS YEAR WE WERE TALKING ABOUT ONE OF THE SPECIAL SUPERPOWERS THAT ARPA-H THROUGH OUR AUTHORITY IS WE CAN DIRECTLY REIMBURSE THE FDA FOR SERVICES PROVIDED AND THERE'S NOT A LOT OF GUIDANCE BEYOND THAT. HOW CAN WE USE THIS TO INCENTIVIZE INDUSTRY TO WORK WITH ARPA-H? THIS IS SOMETHING WE KNOW IS GOING TO BE REALLY ATTRACTIVE TO HAVE INDUSTRY WORK WITH US SO MORE TO COME THERE BUT WOULD LOVE TO HEAR YOUR THOUGHTS AND SOME OF THE REVELATORY CHALLENGES YOU ARE FACING AS WELL. WITH THAT I AM HAPPY TO STOP AND TAKE ANY QUESTIONS FROM THIS GROUP I THINK I HAVE ABOUT FIVE MINUTES REMAINING. THANK YOU AGAIN FOR THE TIME AND REALLY IS AN HONOR TO BE ABLE TO PRESENT THIS GROUP. >>CHAIR TOLBERT: THANK YOU DR. WEGRZYN FOR AN EXCITING PRESENTATION, AND YOUR ENTHUSIASM FOR ARPA-H REALLY POURED OUT. APPRECIATE THAT. ACTUALLY I WANTED TO MAYBE GET A LEAD IN QUESTION. IT KIND OF RELATES TO THIS ORGANIZATION MODEL THAT YOU PUT IN PLACE FOR THE PROGRAM MANAGERS, AND THE TURN OVER. AND WE HEARD EARLIER IN OUR CONVERSATION TODAY ABOUT THE IMPORTANCE OF INCLUSION AND COMMUNITY ENGAGEMENT. THE QUESTION IS HOW DO YOU BALANCE EQUITY, INCLUSION, WITH HIGH RISK PROJECTS, AND PROGRAM MANAGER FOR TURNOVER FREQUENTLY? >>REALLY, I SHARED THAT WE WON'T GIVE A PROGRAM MANAGER A BANK ACCOUNT TO HAVE A CLEAR PLAN ON HOW THEY WILL ADDRESS THAT. WHEN A PROGRAM MANAGER MAKES A BROAD AGENCY ANNOUNCEMENT IT WOULD MAKE INSTRUCTION TO THE TEAM THAT WE WILL NOT FUND YOU AS YOU PROPOSE, SAY CLINICAL TRIAL THAT IS EXEMPLARY OF THE POPULATION THAT IS MOST IMPACTED BY THIS DISEASE. HOW WILL YOU DO THAT? SO BRING THAT TO THE SOLVERS. WE LOOK FOR CREATIVE SOLUTIONS FROM THOSE COMMITTEES THAT WE CAN MAKE THAT AS A REAL GUIDELINE. YOU WILL NOT GET THIS FUNDING UNLESS YOU ACTUALLY ADDRESS THIS CRITERIA. THAT IS SOMETHING WE ARE TAKING REALLY SERIOUSLY AS PART OF THIS. >>CHAIR TOLBERT: THANK YOU. >> THANK YOU FOR THAT THAT IS AN EXCITING INITIATIVE AND ALL OF US ARE LOOKING FORWARD TO HELPING YOU SUCCEED ANYWAY WE CAN. I WANTED TO GET YOUR THOUGHTS TO WHAT YOU THINK ARE ACHIEVABLE TRANSFORMATIONAL GOALS IN A LESS THAN THREE YEAR TIMELINE FOR MY MEDICAL PROBLEMS THAT HAVE A 10 OR 15 YEAR TIMELINE? WHEN IT COMES TO DESIGNING A NEW CHIP OR A NEW TECHNOLOGY A LOT OF THE ADVANCES CAN BE CATEGORICAL. YOU JUST BROKE THROUGH THE BARRIER AND WHEN IT COMES TO BIOLOGY, IS MORE SORT OF NOT AS CLEAR WHAT THE 10 YEAR TIMELINE WOULD BE. YOU MAKE THESE INFERENCES ABOUT THE IMPACT. AND STUDY SECTIONS AS YOU KNOW , KIND OF TAKE YOU AT YOUR WORD THAT THIS IS WORTH ADDRESSING SO WE ARE GOING TO GIVE YOU THE OPPORTUNITY BECAUSE WE ALL SAY IN THE GRANTS THAT WE WILL ADVANCE TO CURE OR TRANSFORM HEALTH AND DO ALL THE THINGS THAT LONG-TERM OBJECTIVES THAT COULD BE REPHRASED SUCH AS ARPA-H. HI DO YOU DEFINE THE FOR THE PROGRAM OFFICER? IF PROGRAM OFFICERS ARE MAKING THAT DETERMINATION, THE OTHER ONES BASED IN THE NETWORK INCLUDE THE CAN APPROACH AND REACH OUT TO. AND THAT IT IS TIED TO THE NETWORK ITSELF AND SO I'M TRYING TO RECONCILE HOW YOU, WHAT YOUR THOUGHTS ARE. >>SO WE ARE NOT RESTRICTED TO ANY KIND OF TECHNOLOGY READINESS LEVEL SO IT CAN BE ANYTHING, 1 THROUGH 9. 1 IS PRUITT THE BENCHTOP AND 9 IS GET THIS ON THE SHELF AT CVS. WE CAN FIND ANYTHING IN THAT SPECTRUM AND WHAT IS REALLY IMPORTANT I THINK, SOMETIMES TO GET FROM 1 TO 9 WILL TAKE 15 YEARS AND THAT THREE YEARS THAT I TALKED ABOUT WILL BE 15 YEARS BUT IT DOES NOT MEAN THAT EVERY PERSON HAS TO END AT THE VERY HIGH TECHNOLOGY LEVEL. AS AN EXAMPLE WHAT ARE THE PROGRAMS AT DARPA STARTED FOR YOU CAN FERMENT A MOLECULE TO MAKE IN MEDICINE. IT TOOK ABOUT TWO YEARS TO DO THAT EVERY TIME WE SAID DO IT A THOUSAND TIMES AND WE KNOW YOU CAN'T DO THAT WITH FORCE, HAVE TO FUNDAMENTALLY CHANGE YOU DO THAT AND WE PROVED THAT WAS POSSIBLE AND INDUSTRY PICKED IT UP. IT IS NOT MEANT TO FUND THE ENTIRE 15 YEARS. IT IS MEANT TO FUND THE SPARK. WHEN I WAS AT DARPA I WAS PART OF THE TEAM THAT FOUNDED MODERNA WHEN THERE WERE FOUR PEOPLE. AND THEN IT WAS LEFT UP TO THE REST OF -- AND HERE WE ARE 10 YEARS LATER, AND I WOULD ARGUE MOST OF US HAVE IT IN OUR ARM RIGHT NOW. THIS IS THE KIND OF SPARK THAT WAS INTENDED AND YOU MENTIONED A NETWORK. IT IS CERTAINLY NOT NETWORK BIASED BUT WE KNOW THAT WILL HAPPEN. PART OF THIS PATIO OFFICES TO TRY TO REMOVE THAT BIAS. SO THERE'S A FEW WAYS YOU CAN DO THAT. WE NEED TO MAKE SURE WE TALK TO ALL THE RIGHT STAKEHOLDERS THAT NEED TO BE AT THE TABLE. WE ALSO WANT TO BE WHERE WE SHARE IN BROAD AGENCY ANNOUNCEMENT DO WE NEED TO MAKE SURE THEY GET BLASTED 12 COMMUNITIES THAT WOULD HAVE RESPOND, AND BRING NEW PLAYERS TO THE TABLE IN FACT IF I HAVE A CONNECTION WITH SOME ORGANIZATION, I WOULD HAVE AN ORGANIZATIONAL CONFLICT OF INTEREST THAT WOULD NOT BE ABLE TO FUND THEM. TO YOUR POINT WE NEED TO BE VERY PROACTIVE ABOUT NOT FUNDING THE USUAL SUSPECTS IF YOU WILL AND THAT WORK. >>CHAIR TOLBERT: WANT TO ALLOW ONE MORE QUESTION FROM DR. GANDHI. >>I AM REALLY SORRY, MY HAND IS NOT SHOW UP WELL ON ZOOM. I REALLY WANTED TO COMMEND JUDY AND TED. I THINK IS THE DUTY OF PUBLIC HEALTH THAT WE CAN'T ELIMINATE MAYBE EVERY SINGLE RISK, BUT TO SHARE DECISION-MAKING ABOUT BREAST-FEEDING WITH WOMEN. IS LONG IN COMING AND NOTHING WILL NOT BE EVER BE ABLE TO ELIMINATE THE RISK IN PUBLIC HEALTH BUT IT IS A DECISION WITH THE PATIENT. AND IT REALLY HELPED ME AS SOMEONE WHO PROVIDES CARE FOR WOMEN HAVE THIS CHANGE MADE. THE SECOND IS THAT THE LONG-ACTING AWARDS PRESENTED AT CROY (PHONETIC), TO TELL YOU WHAT HAS BEEN SPURRED ABOUT THAT THE ECTG PUTTING A REQUEST TO ME AND OTHER STAKEHOLDERS TO SEE WHO COULD DO LARGER STUDY ACROSS ECTG OF LONG ACTING -- -- IN PATIENTS AND IT LOOKS LIKE IT IS GOING TO GO FORWARD IT AND IT WILL BE GREAT TO HAVE A MULTISITE STUDY. IT WOULD TAKE SOME BOLDNESS TO DO IT IN ONE PLACE BUT WE NEED TO GENERALIZE THE ABILITY OF MULTIPLE SITES TO GET IT ON THE GUIDELINES. >>CHAIR TOLBERT: THANK YOU DR. GANDHI. AND THANK YOU AGAIN DR. WEGRZYN, AND WHEN YOU VISIT ORAC YOU CAN GET SWEPT INTO ONGOING CONVERSATIONS. SO WE ARE GOING TO TAKE A BREAK NOW FOR 1 5 MINUTES. I WOULD ENCOURAGE EVERYONE TO TURN YOUR CAMERAS OFF AND YOUR MIC AND WE WILL SEE YOU BACK IN 15 MINUTES. WELCOME BACK, WE HAVE THE BRIEF UPDATES FROM THE COMMITTEES. I WOULD LIKE TO INVITE DR. GUNDY, MARGUERITA LIGHTFOOT, AND GEETANJALI BANSAI WITH THE NATIONAL ADVISORY MENTAL HEALTH COUNCIL, NATIONAL ADVISORY ON DRUG ABUSE, ARAC AND AIDS EXECUTIVE COMMITTEE. MONICA SERVES AS DIVISION CHIEF OF THE DIVISION OF HIV, INFECTIOUS DISEASES AT USF, AND DR. MARGUERITA LIGHTFOOT IS WELL KNOWN TO THE OARAC. CHIEF OF THE DIVISION OF PREVENTION SCIENCE AND DIRECTOR OF THE CENTER FOR PREVENT STUDIES, AT THE PREVENTION PRESEARCH CENTER. AND DR. OAT SERVES AS THE DIRECTOR OF THE GLADSTONE INSTITUTE AND DR. DR. DB, I'M SORRY, I HAD AN A LITTLE TROUBLE WITH MY VOICE. I WILL HAND IT OVER TO DR. GUNDY NOW. >>THANK YOU SO MUCH. I AM WONDERING IF I CAN SHARE THEM MYSELF, IF YOU WANT, I CAN KEEP ON SAYING, NEXT SLIDE. WHATEVER YOU LIKE. NEXT SLIDE. WE ARE GOING TO, I HAD TO GO FAST, I HAVE A LOT OF SLIDE, I AM JUST GOING TO SKIP SOME OF THIS. WE HAD AN AMAZING COUNCIL. THE DIRECTORS REPORT. IT WAS MORE OF AN OVERVIEW ON THE VACCINE RESEARCH PROGRAM. THERAPEUTICS, PREVENTION SCIENCE, WHAT CAN WE LEARN FROM COVID FOR FOR HIV, AND IF WE GO TO THE NEXT SLIDE, THE DIRECTOR'S REPORT, WE TALKED ABOUT THIS. WE HAVE BEEN FORTUNATE, THERE WAS A LOT OF CONSTERNATION ON THE CALL. THE ADVISORY COUNCIL WAS THE PANDEMIC INITIATIVE, NOT APPROVED BY CONGRESS. THAT CONSTERNATION LEAD TO REAL QUESTIONS ABOUT HOW OTHER FUNDING CAN GO TOWARD PANDEMIC PREPAREDNESS. NEXT. THEN WE TALKED ABOUT A MINUTE, ON HOW INCREDIBLE NIH HAS BEEN DURING THE COVID PANDEMIC TO CONTRIBUTE TO RESEARCH AND PROBABLY HASN'T BEEN RECOGNIZED ENOUGH, THAT NOT ONLY DID THEY CONTRIBUTE TO ALL OF THE VACCINE TRIALS IN SOME WAY, AND THE RESEARCH CENTER HELPED TO DEVELOP THE MRNA, THE THERAPEUTIC CONTRIBUTIONS FROM THE NIH, THEY WERE THROUGH THE ACTIVE TRIALS. HARNESSING THE NIH NETWORKS TO LOOK AT ALL OF THE TREATMENTS FOR COVID WAS ONE OF THE GREATEST STRENGTHS THEY HAD TO PLAY IN THIS SLIDE. I THINK I WOULD GO TO THE NEXT SLIDE, THAT SHOWS WHAT WE ARE DOING NOW IN TERMS OF THERAPEUTIC TRIALS. THE NEXT THERAPY TO LOOK AT IS THE PROJECT, PROBABLY THE LAST ONE THROUGH THE EMERGENCY PHASE TO ADD FUNDING TO LOOK AT AN IMPORTANT FOR THE TREATMENT OF COVID. NEXT, I WOULD REFER EVERYONE TO THIS SCIENCE ARTICLE WRITTEN BY FRANNIS COLLINS. NEXT. GOING TO VACCINE RESEARCH. AND THERAPEUTICS. THE VACCINE RESEARCH PROGRAM FOR HIV, WE ALL KNOW IT WAS PUT OUT IN PRESS RELEASE. IT WAS KNOW AN EFFECTIVE VACCINE. NEXT, SLIDE. TO TAKE ANTIBODY, RAISED TO HIGH LEVELS. IT IS SO PROMISING IN TERMS OF A PROFOUND UMMUNE -- IMMUNE RESPONSE. NEXT SLIDE SHOWS US. THERAPEUTIC PROGRAM THAT IS WEIGHTED AS IT SHOULD BE TOWARD CLINICAL TRIALS, HOW MUCH IS GOING IN IN THE NEXT SLIDE, PLEASE. WHAT WE TALKED ABOUT ON THE SESSION THERE IS A VERY BIG FOCUS ON NEW AND IMPROVED, LONG ACTING TREATMENTS FOR THE NEXT PHASE OF THE TREATMENT. AND NOT ONLY THROUGH DEMONSTRATIONAL PROJECTS, I THINK IMPORTANTLY, THROUGH THE CLINICAL TRIALS NETWORKS AS WE TALKED ABOUT. THEN END WITH THE LAST PART, WAS TALKING ABOUT THE PREVENTION SCIENCES. THE NEXT SLIDE SHOWS THE PREVENTION. I THOUGHT IT WAS A GREAT SLIDE TO SHOW WHAT THE PROGRAM IS INVOLVED IN. IT IS SO DIVERSE. ALL THE WAY FROM EVOLVING RESEARCH, AND INFANTS AND CHILDREN, TO IMPROVING ENGAGEMENT IN KEY POPULATIONS, ALL THE PRIORITIES, YES, FLKS SLIDE. AND SO, I THINK THE ONES THE PREVENTION SCIENCE PROGRAM HIGHLIGHTED FOR US, ARE THE HIGHLIGHTS WE TALKED ABOUT THE CALL. THE REGULARATORY APPROVAL FOR CHILDREN. AND THE ANTIBODIES, AND THE LACTATING MOTHERS. A FEW MORE R APP S, REALLY, LOOKING, 52% OF CHILDREN HAVE ACCESS TO THE STATISTICS FROM THE ENDAFR REPORT. NEED TO WORK MORE ON PEDIATRIC FORMULATIONS ON MEDICATIONS. BIOLOGY, CURE AND PREVENTION. YOU CAN SEE HOW THEY ARE OVERLAPPING. THE NEXT SLIDE, ALL THE INITIATIVES FOR STRUCTURAL BIOLOGY. INCLUDING A PROGRAM HERE, AND THE NEXT SLIDE, THE CURE INITIATIVES. THROUGH THE DIFFERENT COLLABORATIONS. REALLY, ABLAZING CURE PROGRAMS ALL OVER THE COUNTRY. AND THE NEXT SLIDE, SHOWS THROUGH THE BASIC SCIENCE PROGRAM. EHE MONEY, HAS BEEN GOING OUT. AND THEN END WITH THE NEXT SLIDE. NEXT SLIDE. THIS IS WHAT I TOOK FROM WHAT WORKED DURING COVID FOR US. KIND OF RAPID TRIAL DESIGNS, USING THE FRAMEWORK, AND WHAT DIDN'T WORK. REGULATORY TIMELINES DELAYED IN OTHER COUNTRIES. COMPLEX TRAVEL DESIGNS DIDN'T WORK. WE NEEDED TO USE REAL WORLD EVIDENCE AND HARNESS THAT TO GET THE INFORMATION OUT THERE. IT WAS ONE OF THE BEST AND MOST COMPREHENSIVE MEETINGS I EXPERIENCED. >>THANKS YOU DR. GANDHI. MARGUERITA LIGHTFOOT. I AM HERE TO REPORT IMH. IN TERMS OF THE APPROPRIATIONS AND BUDGE FOR NIMH HAS BEEN INCREASING CLOUDS. AND EXPANSION OF BUDGET TO ADDRESS COVID 19 AND MENTAL HEALTH, THAT WILL BE ON-GOING. THE DIRECTOR TOLD US ABOUT THE NEW INITIATIVES AT NIMH IS PART OF. HHS RELEASED ROAD MAP FOR BEHAVIORAL INTERIGRATION. IN THE FIRST, THE PRESIDENT'S FIRST STATE OF THE UNION TALKED ABOUT THE PROVIDING SUPPORT, AND NIMH IS IT WILLY INVOLVED IN THAT. MEMBERSHIP OF US KNOW CONFUSING DATA SHARI REQUIREMENTS ARE REQUIRED FOR GRANT PROPOSALS, I AM TAKE A UNIQUE PROSPECTIVE. DURING REVIEW, REVIEWERS ARE COMMENTS ON THE DATA SHARING REQUIREMENTS. ANY DATEDA SHARING PROVIDED BY THE INVESTIGATORS WAS INADEQUATE, IT WON'T KEEP THE GRANT FROM BEING FUNDED AT NIMH. THEY HAVE A TEAM THAT WILL BE WORKING WITH ADVISORY TO BRING UP TO SPEED PLANS IN THE GRANTS THAT WERE NOT REVIEWED WELL. I AM ANXIOUS, SPENDING A LOT OF TIME AND EFFORT IN WORK FIRST DEVELOPMENT. WORK FIRST DEVELOPMENT, PARTICIPATING IN TWO PROGRAMS, ONE IS THE SUPMRIMENT FOR -- SUPPLEMENT FOR DEI MEMBER, THIS IS THE SUPPLEMENTS WILL BE AVAILABLE FOR ALL GRANT TYPES, INCLUDING CURRENT DEVELOPMENT GRANTS, COOPERATIVE AGREEMENTS AND RESEARCH, THEY WILL PROVIDE UP TO 250,000 IN DIRECT COST TO THE PARENT GRANT. THE OTHER ONE, RESEARCH OPPORTUNITIES FOR NEW AND AT-RISK INVESTIGATORS TO PROMOTE WORK TOWARD DIVERSITY IS INTENDED TO SUPPORT NEW INVESTIGATORS, AND AT-RISK MEANS A PI, ON A SUBSTANTIAL RESEARCH AWARD, A LESSER SUCCESS IN SECURING THE NEXT GRANT IN THE CURRENT FISCAL YEAR,TYPICALLY, THESE ARE GOING TO BE FOLKS LOOKING AT, WITHOUT GETTING THAT NEXT GRANT. AND OF NOTE, THE NIMH STJIC FRAMEWORK. AND THE NEXT SLIDE, PLEASE. WE HEARD ABOUT A PRESENTATION ABOUT THE GLOBAL MENTAL HEALTH RESEARCH CENTER THAT IS HAPPENING BEEN FORMED AT NIMH, THE IDEA BEHIND THE CENTER IS TO WORK WITH LMICs TO EMMRIMENT AND ADOPT AND SCALE UP EVIDENCE-BASED MENTAL HEALTH INTERVENTIONS, AND THE FOCUS OF THIS GROUP IS LOOKING AT THE POTENTIAL FOR MULTIDIRECTIONAL EXCHANGE. ADAPTATION, RECIPROCAL LEARNING BETWEEN LMICs, AND THE INVESTIGATORS. SOME OF THE LESSONS LEARNED FROM THE WORK THAT HAS HAPPENED SO FAR, BY THE CENTER, IS THAT GROUP LEARNING IS POWERFUL. CROSS SECTION, MULTISECTORED GROUPS TOGETHER TO THINK ABOUT HOW WE SCALE UP INTERVENTIONS FOR MENTAL HEALTH. IN THE U.S., DISTRESS IS INCREASING GLOBALLY. USING AN IMPLEMENTATION SCIENCE, AND EFFORTS FORWARD THAT IS SOMETHING LOOKED AT HERE. THERE ARE A NUMBER OF RESEARCH PARTNERSHIPS FOR SCALING UP LMICs, ACROSS THE COUNTRY. SO, THEY ARE IN SOUTH AFRICA, PERU, LIBERIA, AFGHANISTAN, I WON'T CATCH ALL OF THEM. IT IS A REFLECT OF GLOBAL REACH. NEXT SLIDE, PLEASE. WE DID HEAR FROM THE DIVISION FOR AIDS RESEARCH NIMH. THEY HAD CONCEPT CLEARANCE REVIEWED BY THE COUNCIL MEMBERS, AND SUPPORTED BY COUNCIL MEMBERS AS WELL. THERE WAS SUPPORT, IT WAS CALLED RECIPROCAL INFORMATION. AND CENTRAL NERVOUS SYSTEM NEUROPATHOGEN SIS AND CURE. GOAL IS TO ENCOURAGE RESEARCH USING NOVEL CNS CELL SYSTEMS, ERADICATING, AND UNDERSTANDING THE MECHANISMS IN AIDS RESEARCH. THE OTHER PARTS OF THE RATIONAL FOR THIS CONCEPT CLEARANCE, HIV CONTINUES TO BE OBSERVED IN PATIENTS, AS WE ALL KNOWS, RESIDUAL LEVELS OF AND PERSISTENT LEVELS OF INFLAMMATION, AND PERSISTENCE CONTINUES TO EXIST. HOPEFULLY, TO BE ABLE TO ADDRESS THAT. NEXT SLIDE, PLEASE. I THINK THAT MIGHT BE IT. THANK YOU. THANK YOU DR. OAT, OVER TO YOU. I AM A NEW MEMBER, I HAD MY FIRST MEETING FEBRUARY 8th, INTERESTING AND PRODUCTIVE MEETING. IT WAS CENTERED A LOT AROUND THE FENTANYL CRISIS. WANTED TO BRING TO YOU, TWO PAPERS, TWO CONCEPTS THAT I SHOULD HIGHLIGHT WITH YOU, THAT IN THE HIV AREA. THE FIRST ONE, THE RECENT MOLECULAR CELL, RESEARCH AND FOCUS AT NIGHTA WITH THE BRAIN. HIV AND SUBSTANCE ABUSE OR SUBSTANCE ABUSE DISORDERS. THIS PAPER HAS DONE AN AMAZING JOB, USING SOPHISTICATED GENOME ANALYSIS TECHNOLOGIES, STARTING FROM SINGULAR NUCLEUS, HIGH-C, AND SEQUENCES, TO FRONTAL CORTEX SAMPLES WITH INSEF LIGHTS OR WITHOUT ENCEPHALITTIS. AND INTERESTING OBSERVATIONS WERE MADE. THROUGH 3-D. REMODELLING HERE. AT VERY SPECIFIC SET OF NURRAL GENES WERE FOUND REPRESSED, AND SHOWN THAT ENCEPHALITIS G NO CONFIGURATION, AND STIMULATED GENE EXPRESSION. THERE IS ALSO CLEAR EVIDENCE THAT HIV TARGETS GENOMIC REGIONS, AND HIV IS TRANSCRIBED IN IT WAS CLEAR THAT DURING ENCEPHALITIS EXPRESSION OF HIV IS ENHANCED. THE NEXT SLIDE, PLEASE. THE SECOND PAPER IS FOCUSED ON THE SECOND AREA OF FOCUS. HOW CAN LATENCY BE ADDRESSED, BETTER UNDERSTOOD, AND THERAPEUTICALLY REVERSED OR ENFORCED. THIS IS A STUDY FROM THE EMER MAN LAB, THAT PERFORMED A SCREEN IN CELLS, PROVIRUS, TO IDENTIFY FACTORS THAT REPRESS THE SCREEN WAS DONE WITH THIS TO REACTIVATE THE VIRUS. TO IDENTIFY FACTORS THAT WOULD ENHANCE OR BLOCK THE REACTIVATION. YOU MIGHT ASK WHY ANOTHER, HIGHLY CURATED DIET ENA, FOCUSED ON GENETICS, SO THAT OTHER PATHWAYS, THAT CAN OVERSHADOW QUESTION HOW IS THE VIRUS REGULATED. I AM NOT ADDRESSED IN THIS. AND BURYING OTHERWISE INTERESTING HITS. THEY CAME BACK TO AN ALREADY KNOWN FACTOR, THE TRANSFER, A SUBSET OF THIS IN A FACTOR HIGHLIGHTED HERE ON THE SCREEN. THAT SEEMED TO BE IMPORTANT IN PRECESSING HIV, IT IS AN INTERESTING CONCEPT. THE CONCEPT THAT ASSETALATION IN HIV LATENCY IS CLEARLY ASSOCIATED WITH REPRESSION. THAT IS VERY INTERESTING. NEXT SLIDE, PLEASE. THE 2025 CONCEPT HAS BEEN FINALIZED. LISTED HERE. I WILL LET YOU GO THROUGH THEM. I WANT TO FOCUS ON THE TWO HIGHLIGHTS HERE. HIV AND ADDICTIVE DRUGS, AND MITHE FOCUS HERE IS ON THE BRAIN. IN THE FIRST INITIATIVE, IT REALLY IS LOOKING IN THE COMBINATION OF THE NEUROAND THE CENTRAL NERVOUS SYSTEM AND THE HUMAN SYSTEM, I WANT TO HIGHLIGHT ONE SENTENCE HERE IN THE LOWER PART, STUDIES INVESTIGATIONING THE NEUROIMMUNE CROSS TALK, AND NEUROCOGNITION, BEHAVIOR AND SUBSAN ANTONIO USE, THE IMMUNE SYSTEM AND THE CENTRAL NERVE SYSTEM IS INTERESTING TO SEE HOW IT THEN CHANGES BEHAVIOR, AND IT CHANGES HIV INFECTION. THE OTHER THE NEXT ONE, PLEASE. IT IS ALSO VERY MUCH FOCUSED ON THE BRAIN. HERE, IT IS CLEAR THAT MICROGLIAL, BETWEEN HIV AND SUBSTANCE ABUSE DISORDER, IT IS A CONVERGENCE POINT, IN THE WAY THAT THESE CELLS PLAY AN ENORMOUS ROLE HAR VESING IT, SUBSTANCE DISORDERS AFFECTING THE BEHAVIOR AND CHANGES PATHWAYS IN THE BRAIN. THIS IS AN INITIATIVE THAT IS SEEKING PROFILING OF THE MICROGLIAL CELLS, MODIFYICATIONS TO SEE HOW THEY BEHAVE AND LOOK IN DISEASE AND HEALTH. THE FOCUS HERE IS REALLY NOT ON ISOLATED CELLS, BUT ON BRAIN REGIONS, AND SPECIFIC BRAIN REGIONS, AND IT IS ENCOURAGED TO USE HUMAN OR ANIMAL MODELS TO LOOK AT MICRO GLIAL, RATHER THAN IN AN ISOLATED MODEL. I HAND IT OVER TO THE NEXT SPEAKER. >>THANK YOU. OVER TO YOU NOW, DR. GEETANJALI BANSAI. >>CLEARED CONCEPTS, NEXT SLIDE, PLEASE. THIS IS A SUMMARY, WITH A TOTAL OF 17 NEW, AND REISSUED CONCEPTS. NATIONAL INSTITUTION OF MINORITY HEALTH HAS TWO NEW CONCEPTS, FOCUSING ON HEALTH DISPARITIES, WITH THOSE LIVING WITH HIV, HOUSING AND FOUR NEW CONCEPTS, ONE FOCUSES ON THE DELIVERY TREATMENT FOR TREATMENT, A SECOND CONCEPT IS THE RAPID DIAGNOSTICS, SELF MONITORING, AND ANOTHER ONE, HEP TITUS B, C, AND HIV. AND HCV CURE. THE NEXT SLIDE, PLEASE. NATIONAL INSTITUTION ON DRUG ABUSE NEW CONCEPTS LISTED HERE. ALREADY PRESENTED TODAY. NEXT SLIDE. A NEW CONCEPT ON THE HIV, AND OROPHAR LANGIAL CANCER. NATIONAL INSTITUTE OF MENTAL HEALTH, REVIEWED IN A PRESENTATION. NEXT SLIDE, PLEASE. NATIONAL INSTITUTE OF DRUG ABU, SIX CONCEPTS LISTED HERE. NEXT SLIDE. NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM, REISSUED TWO CONCEPTS THE REFRESH YOUR RECOLLECTIONS O1, AND REFRESH YOUR RECOLLECTIONS 34. THE INCIDENCE OF NEW INFECTIONS. NEXT SLIDE, PLEASE. THE OFFICE OF RESEARCH AND INFRASTRUCTURE PROGRAMS. IMPORTANTLY, USING THE ORIP ISSUE ISSUED APPLICATIONS FROM RESEARCH INSTITUTIONS TO SEEK FUNDS TO DEVELOP RESEARCH FACILITIEDS THAT SUPPORT HIV RESEARCH, IN THE AREAS OF BASICALLY SOCIAL, AND BEHAVIORAL RESEARCH. UNDER SERVED POPULATIONS, AND INSTITUTIONAL DEVELOPMENT OR IDEA ELIGIBLE STATES, THE FACILITIES HIV RESEARCH. WE WILL STOP HERE. COLLEAGUES, WE HAVE ABOUT A MINUTE FOR ANY QUESTIONS OR COMMENTS. FROM THE LAST PRESENTERS. SEEING NO HANDS. WE WILL MOVE ON AND THE AGENDA, WE ARE IN THE HOME STRETCH HERE. THE NEXT PART OF THE AGENDA, WE WILL HEAR FROM THE HIV CLINICAL GUIDELINES WORKING GROUPS. BOTH GUIDELINES AND PANEL UPDATES, WE WILL HAVE TWO PRESENTERS, THE FIRST PRESENTER IS DR. GULICK, WELL KNOWN COLLEAGUE AND FORMER ESHG CHAIR. HERE IS THE ROCHEL SUBDIVISION OF INFECTIOUS DISEASES, WEILL MEDICAL COLLEAGUE OF CORNELL UNIVERSITY. H.P.T. NETWORKS, OUR SECOND PRESENTER IS DR. MASUR, CHIEF OF THE CRITICAL CARE MEDICINE DEPARTMENT NIH, GUIDELINES FOR OPPORTUNISTIC INFECTIONS IN ALL THES AND ADOLESCENTS. PAST PRESIDENT OF IDSA. WE WILL START WITH DR. GULICK, OVER TO YOU. >>THANK YOU. DR. TOL BERT. GREETINGS TO THE ESHG, PLEASURE TO SEE YOU ON ZOOM. OVERVIEW ON THE CLINICAL PRACTICE GUIDELINES PROCESSES. WHY IS THAT? NEXT SLIDE. WELL, BECAUSE THE HIV CLINICAL GUIDELINES, AND THERE ARE FIVE OF THEM, ARE WORKING GROUPS OF OARAC. FEDERALLY APPROVED CLINICAL PRACTICE GUIDELINES FOR HIV AIDS. YOU KNOW THEM WELL. THEY ARE LISTED HERE. LEFT TO RIGHT, THE ADULT AND ADOLESCENT GUIDELINES, AND ADULT AND ADOLESCENT OPPORTUNISTIC INFECTIONS, PED AT RICK ARV, AND PEDIATIC OPPORTUNISTIC GUIDELINES, AND THERE ARE THE PERNATAL CLINICAL GUIDELINES, THEY ARE ALL AVAILABLE AT CLINICAL INFO HIV.GOV. OF THE FIVE, THE ONES THAT I KNOW THE BEST ARE THE GUIDELINES FOR THE ANTIRETROVIRAL AGENTS IN ADULTS AND ADOLESCENTS WITH HIV. I WILL FOCUS ON THE ADULT GUIDELINES. WHAT ABOUT THE HISTORY OF THE GUIDELINES, WHERE DID THAT KIFRESHMAN? IN 1996, THE PANEL WAS FIRST COCONVENED BY DHHS AND THE CASER FOUNDATION, CONCEIVED AS A PRIVATE PARTNERSHIP. WHY DID WE NEED THIS? 1996 WAS A BANNER YEAR IN HIV, THAT WAS THE YEAR THEY APPROVED THREE INHIBITERS. IT WAS FELT THAT THEY NIGHEDED GLIDANCE. THE GOAL WAS TO PROVIDE GUIDANCE. NEXT, THE FIRST GUIDELINES WERE PUBLISHED AFTER THE PANEL MET IN THE MMWR. THEY WERE RELATIVELY SHORT, AND GAVE DIRECT INFORMATION TO PRACTICING CLINICIANS AS TO HOW TO USE ART. LATER, FAST FORWARDING, 2005, THE GUIDELINES BECAME A WORKING GROUP OF THE OFFICE OF AIDS RESEARCH ADVISORY COUNCIL, THAT IS YOU ALL. WE CURRENTLY GOT UPDATE EACH OF THE FIVE SETS OF GUIDELINES, ONCE OR TWICE A YEAR, DEPENDING ON THE NEED. NEXT. HERE IS THE PANEL STRUCTURE, THERE ARE TWO CO-CHAIRS, CLIP LANE FROM NIH, I AM THE ACADEMIC CHAIR, AND THE EXECUTIVE SECRETARY. THERE ARE FIVE MEMBERS FROM PARTS OF HHS, REPRESENTATIVE FROM THE CDC, AND HIH, HRSA. THERE ARE 38 SCIENTIST MEMBERS FROM ACADEMIC CONSTITUTION INSTITUTIONS ACROSS THE UNITED STATES, AND ADDITIONALLY, THERE ARE FIVE COMMUNITY MEMBERS. WE HAVE THREE NONVOTING OBSERVERS FROM OTHER GUIDELINE PANELS, PERRYINATELY, AS WELL AS A CLINICAL PHARMACIST. THE XSHT EASE FOR THE GUIDELINES, SPANS AM MULTIPLE AREAS, EXPERTISE AND ADOLESCENTS, VIRAL HEP TITUS, BIOSTATISTICS, IMMUNOLOGY, SUBSTANCE USE, TRANSGENDER CAR, COMORBIB IDS, AND COST EFFECTIVENESS. THREE NONVOTING OBSERVERS, THREE NONMEMBER CULTANTS, ONE IS AN EXPERT IN HIV AND TREATMENT. THE FLAUN HHS MEMBERS ARE SELECTED THROUGH OPEN APPLICATIONS, THAT WOULD BE THE 38 CLINICAL AND SCIENTIFIC MEMBERS. THEY EACH SERVE A FOUR-YEAR TERM, HAVE THE OPTION TO REVIEW IT ONE TIME. NEXT, WE HAVE AND IN OUR STRUCTURE, 21 WRITING TAMS, FOCUSED ON DIFFERENT AREAS OF IMP SYSTEM. 4 TO 12 MEMBERS. THAT IS WHERE THE WORK OF THE GUIDELINES IS DONE. THIS WILL SHOW YOU HOW WE DEVELOP AND REVISE THE GUIDELINES, NEXT, THE FIRST THING WE DO IS REVIEW THE LITERATURE, THE PUBLISHED LITERATURE, ABSTRUCTS PRESENTED AT CONFERENCES, THESE DAYS, PRESS RELEASES AND PRE-PRINTS ARE PART OF THE BODY OF LANGUAGE THAT WE REGALLY, NEW SECTIONS OF THE GUIDELINES. ONE OF THOSE WRITING SCHEMES, FOCUSES ON THE DRAFTS, CIRCULATES TAKES COMMENTS TO DRAFT A NEW SEKSZ OR UPDATED SECTION OF THE GUIDELINE. MOST OF THE WORK IS DONE WITHIN THE SUBTEAM. ULTIMATELY, THEY PRODUCE A FINAL DRAFT, WHICH GOES TO THE FULL PANEL AND PRESENTED AT ONE OF OUR MONTHLY CONFERENCE CALLS. THE ENTIRE PANEL HAS THE RIGHT TO GIVE FEEDBACK ON AN INDIVIDUAL SECTION, AND THE TEAM WILL REVISE THE SECTION BASED ON THE COMMENTS, THE PANEL VOTES FOR EACH NEW RECOMMENDATION, AND BASED ON THAT, THE TEAM WILL INCORPORATE COMPLENTS AND THE VOTE WILL FULLY PROVE THE SECTION TO MOVE FORWARD >>THE NEXT STEPS, SUBMIT TO HIV INFO, AND ULTIMATELY, THE SECOND IS REVIEWED BY THE EXECUTIVE SECRETARY TO FINALIZE IT. IT WOULD BE PUBLIC. IMPORTANT TO KNOW THAT ALL OF OUR TEAMS WORK SIMULTANEOUSLY. FROM START TO COMPLETION OF A REVIG, CAN TAKE BETWEEN 4 AND 9 MONTHS, WE TYPICALLY, UPDATE THE RELEASE ABOUT ONCE A YEAR FOR A NEW VERSION OF THE GUIDELINES. NEXT. NEXT. SO, HERE ARE THE CURRENT GUIDELINES, SECTIONS, WHAT IS NEW, THE BASELINE EVALUATION. LAB TESTING, TREATMENT GOALS, INITIATION OF ART, WHAT IS TO START. WHAT NOT TO USE. MANAGEMENT AND THEN, CO-INFECTION, OLDER PEOPLE, SUBSTANCE USE, TRANSGENDER AND WOMEN. A FEW LAST SECONDS, ART AND CO-INFECTIONS, LIMITATIONS TO ARC, A HELPFUL SECTION ON RENAL DOSING TABLES. WE HAVE THE TUNGZ TO MAKE INTERMITEN RELEASES, IF THERE IS RAPID COMMUNICATION THAT NEEDS TO BE PROVIDED TO PROVIDERS ACROSS THE U.S. AN UNDER THE TIME OF CONCEPTION, RERAYING IT THIS INFORMATION TO U.S. PROVIDERS. YOU CAN SEE THE TITLES THERE. THE OTHER THING THAT WE CAN DO IS OFFER SPECIFIC GUIDANCE. HOW DO YOU MANAGE PEOPLE LIVING WITH HIV DURING A DISASTER, WE CAME UP FOR FORMAL GIANS FOR CARING FOR THOSE PEOPLE LIVING WITH HIV. THESE ARE POPULAR GUIDELINES FROM AROUND THE WORLD, THESE ARE RECENT, YOU CAN SEE 6, 6 SEVEN,000, THE AUSTRALIANS USE THEIR GUIDELINES, AND ANNOTATE THEM FOR THEIR USE. OF ALL THE GUIDELINES AROUND THE WORLD, THEY CHOSE US, WHICH WE ARE PROUD OF. WE COMMUTE WITH THEM. THANKS ON OARAC FOR SUPPORTING US OVER THE MANY YEARS, OF COURSE, THE OFFICE OF AIDS RESEARCH, AND MY COACH, AND SECOND AND MY LAST SLIDE LISTS THE NUMBERS. CAN YOU SEE, WE HAVE BROUGHT REPRESENTATION FROM ACADEMIC CENTERS ACROSS THE COUNTRY, AND THE FOUR COMMUNITY MEMBERS, FROM LOS ANGELES, THE DISTRICT OF COLUMBUSIA, SAN DIEGO AND I WILL STOP THERE, THANKS FOR YOUR ATTENTION. >>WE WILL MOVE ON TO DR. MASURE. >>THANKS. THANK YOU FOR THE OPPORTUNITY TO PRESENT THE GUIDELINES, HOW ABOUT PROCESS IS SIMILAR, NOT IDENTICAL. OURS ARE A LITTLE DIFFERENT STRUCTURE. WE DO THIS JOINTLY WITH THE INFECTIOUS DISEASE SOCIETY, AND WITH CDC, SO THAT OUR CO-CHAIRS, IN ADDITION TO ME, CONNIE BENSON, JOHN BROOKS FROM CDC, AND ALICE POW, ONE OF THE CO-CHAIRS AS WELL. WE ARE CONCERNED WITH HOW MUCH USE THE GUIDELINES HAVE. WE WILL LIKE TO RECOGNIZE THOSE WHO USE IT WISELY. THESE GUYS ARE FREQUENTLY ACCESS, WHILE THE GUIDELINES DON'T ACCESS AS OFTEN AS THE A ART GUIDELINE, 5,000 STAGE VIEWS, THESE ARE LARGELY IN THE UNITED STATES, NOT EXACTLY, THE GUIDELINES ARE FOCUSED ON THE U.S., THAT IS WHAT WE ARE CONS CONSTITUTED WITH, WE DO THINK THEY HAVE WIDE INFLUENCE. FLKS SLIDE. IF YOU LOOK AT WHAT SECTIONS ARE BEING USED, 29 DIFFERENT CHAPTERS ON INDIVIDUAL PASSAGES, GROUPS OF PASSAGES, IT IS ALWAYS INTERESTING TO SEE WHAT SECTIONS ARE USE ARES A OUR USERS ARE LOOKING AT. MAINTAIN ON THE LESS USED SECTIONINGS, THOSE ARE THE ONES, WHEN YOU GET A CASE OF HIV THAT IS WHEN YOU ARE MOST DESPERATE FOR SOMETHING UP TO DATE AND RELEVANT. EVEN THE LESS USE. NEXT SLIDE. WE UPDATE THESE, MOST RECENTLY, UPDATED THE HEP-C VIRUS SECTION. OUR SECTION GROUPS MEET AS A GROUP. WE ASK THEM WHAT IT NEEDS TO BE UPDATED. WE PUBLISH UPDATES THROUGHOUT THE YEAR. NEXT SLIDE. SOME OF THE ADMINISTRATIVE CHANGES WE ARE MAKING WE LOOK TO SEE, ARE THEY READABLE? ARE THEY EASY TO ACCESS? WHAT DO THE PARTNER OTHERS WANT. TO BE MORE INVOLVED, LOOKING AT THE CONTENT. THEY GIVE US USEFUL FEEDBACK. THEIR FEEDBACK OR SESSION CDC ALSO DOES THIS. WE ARE IN THE PROCESS OF WORKING WITH OUR SUBJECT GROUP, SIMPLIFY THE TABLES TO MAKE THEM MORE READABLE. WE HAVE A SECTION REVIEW GROUP, WHO READ EACH GROUP AND MAKE SESSIONS AS TO WHETHER OR NOT THE SECTIONS ARE CLEAR, PRACTICAL AND CONFORM TO WHAT PEOPLE ARE ACTUALLY DOING. NEXT SLIDE. THIS IS AN EXAMPLE. RECENTLY, WE Z DVEN UPDATES, WE CHANGED OVER TABLES, IN THE NEAR FUTURE, WE ARE MAKING MORE CHANGES, THEY WILL BE ROLLED OUT PERIODICALLY THROUGHOUT THE YEAR. THAT COMPLETES THIS UPDATE. AGAIN, WE VALUE FOR OAR, AND HAVING UPTO DATE INFORMATION WE ARE ABLE TO UPDATE MORE FREQUENTLY THAN BOOKS AND SOURCES. WE ARE HAPPY THEY GET USED. THANK YOU VERY MUCH. >>WE Z QUITE A BIT OF TIME LEFT FOR SOME GOOD Q AND A. >>THANK YOU FOR THOSE PRESENTATIONS, THANK YOU FOR ALL THE WORK YOU DO, PUTTING THE GUIDELINES TOGETHER. IT IS AN UNVALUABLE RESOURCE. GET YOUR INSIGHTS, WHETHER OR NOT YOU HAVE CONSIDERED MAKING GUIDELINES FOR CARING FOR PERSONS IN HIV TRIALS. WE FIND THAT AT LEAST IN THE CONTEXT OF TRIAL RECRUITMENT, RECURRENT EXPERIENCES THAT WE HAVE TO EDUCATE THE PROVIDERS ABOUT MAKING THEM COMFORTABLE, SO THEY ALLOW THEIR PATIENTS TO PARTICIPATE OF RESEARCHERS, COMFORTABLE WITH THIS NOTION. THERE IS THE CENTER CITY AND OUTSIDE PROVIDERS, MORE FOREIGN TO THIS. HOW DO WE GET MORE WOMEN INVOLVED. PROVIDERS, SOMETIMES NOW PART OF THE ACADEMIC CENTER, THEY ARE LESS VERSED IN THE RESEARCH PROCESS. WHEN WE APPROACH THEM, THE PARTICIPANT, MANY TIMES THEY SAY ABSOLUTELY, TALK TO THE PROVIDER AND SAY, YOU KNOW, IT IS A RISK, WHATEVER. THE DISCUSSION ENDS. THERE MAY BE AN OPPORTUNITY TO AT LEAST DISCUSSION IF THERE IS VALUE TO CREATING A RESOURCE THAT COULD MAYBE FACILITATE THIS DISCUSSION OR EDUCATION. I AM NOT SAYING, MAYBE YOU HAVE IT, I AM INTRODUCING AT LEAST A GAP THAT WE FACED OFTEN, I AM SURE YOU ARE AWARE OF IT AS WELL. COULD THIS TOOL BE SOMETHING IN THE TOOL KIT WE COULD CONSIDER. >>TRIP AND I WOULD BE INTERESTED TO SEE IF WE HAVE IDENTICAL OR PARALLEL VIEWS. THE ONLY GUIDELINES THAT I AM AWARE OF HAS BEEN WILLING TO DO. THEY ARE SO TIME INTENSITY, AND IT IS NOT EXACTLY OUR MISSION. YOU COULD ARGUE THAT IT IS IMPORTANT THAT WE COMMUNICATE. THE ONLY THINGS WE DO, IS HIV GUIDELINES AND SO VID. WE HAVE TRIED TO THE FOCUS GUIDELINE, TO FOCUS ON THE MISSION. TO UPDATE, THERE ARE MANY THINGS WE CAN DO. THE QUESTION IS, IS THAT AN INVESTMENT THEY WANT TO MAKE? IS THAT OUR ROLE? THESE ARE ENORMOUSLY TIME CONSUMING. THE QUESTION HOW WOULD YOU ANSWER THAT >>I AGREE WITH YOU, NOT SURPRISINGLY. THAT IS A GREAT POINT. IN CLINICAL TRIALS, HOW DO WE EDUCATE COMMUNITY PROVIDERS ABOUT CLINICAL TRIALS, WHAT THEY MIGHT DO FOR US. AS HENRY MENTIONED, IT MAY BE OUT OF -- IN THE GUIDELINES, WE INCORPORATE THE RESULT. WHEN WE GIVE RESULTS, UNANSWER ED THE NEXT STEP, CLARIFYING, WHAT ARE CLINICAL TRIALS, WHAT CAN THEY DO FOR YOU, THAT MAY BE BEYOND OUR PERVIEW. OTHER GROUPS MAY BE THINKING ABOUT THIS. >>LET ME MAKE A POINT FROM SOMEONE WILL RESPOND. FOR THE INDIVIDUAL PANELS. I AGREE WHAT YOU ARE PROPOSING IS IMPORTANT. THESE PANELS TAKE AING HUGE AMOUNT OF INPUT FROM VOLUNTEERS, RIGHT NOW, ESPECIALLY IN COVID, THE VOLUNTEERS, IT IS REMARKABLE HOW MUCH TIME THEY ARE WILLING TO VOLUNTEER. I ACCEPT IT WOULD BE WITHOUT CREATING DIFFERENT PANELS. I DON'T KNOW IF ANYONE ELSE WOULD LIKE TO MAKE A COMMENT OR RATHER THAN MAKE A COMMENT ON THAT MAUREEN? I THINK YOU ARE ON MUTE. >>BUT I SAID ALL THE GOOD STUFF. I WAS THANKING TRIP AND HENRY. GOOD TO SEE THEM. WE ARE IN LISTENING MODE, HENRY, IN TERMS OF GETTING INPUT TO THIS IDEA FROM THE OARAC FLBS AND CONSIDER WHAT FURTHER WHAT WE SHOULD DO ABOUT IT. I WOULD LIKE TO HEAR WHAT OUR OARAC NUMBERS IN GENERAL THINK ABOUT IT. I THINK THERE ARE TWO QUESTIONS, IS THIS WORTHWHILE, AND IS THIS AN INTERESTING LINK BETWEEN CRITICAL CARE AND RESEARCH TO DEVELOP CLINICAL CARE. AND THE PRODUCTS THAT ARE PUT INTO CLINICAL CARE F SO, HOW COULD THIS BE? I THINK IT IS A TWO-PART QUESTION. THANKS. >>I WILL PASS IT OVER TO MARY, BRIEFLY. >>THANK YOU DOCTOR, I WANTED TO MAKE SURE WE WERE ALL AWARE THAT DR. RONALD WILCOX ARE WITH US, AND DR. ROHAN, THEY ARE MEMBER OF THE PEDIATRIC PANEL. WE WERE JOINED BY THE PRENATAL PANEL. IF THERE ARE QUESTIONS REGARDING THE FEEDING GUIDELINES MENTIONED EARLIER, FEEL FREE TO ASK THEM AS WELL. >>THANK YOU. >>DR. MILLER? >>I JUST WANTED TO THANK TRIP, AND HENRY FOR THE PRESENTATIONS, HAVING SPENT TIME TALKING ABOUT THE GUIDELINES, NOT JUST FOR THE CARE OF PATIENTS BUT ACCESS TO THE CARE THEY NEED IN TERMS OF SUPPORTING REIMBURSEMENT AMONG THE COMPLICATED REIMBURSEMENT PARTIES THAT WE HAVE HERE IN THE U.S. IN JUST FOR THE REMINDER HOW SPECIAL THE NIH TREATMENT PANEL IS. I DON'T BELIEVE IT EXISTS IN THAT FORM FOR ANY OTHER DISEASE. I MAY BE WRONG. TO HAVE A FEDERALLY APPROVED NIH GUIDELINES PANEL, THAT INCLUDES, ALL THE AGENCIES, I THINK IT IS UNIQUE. PLEASE CORRECT ME IF I AM WRONG. TO ACKNOWLEDGE, NOT JUST THE AMOUNT OF TIME IT TAKES ON THE PARTICIPANTS AND PANEL MEMBERS, BUT ALSO, ON THE LEADERSHIP ON PEOPLE LIKE YOU AND ALICE. IT MADE ME WANT TO THANK EVERYBODY FOR THEIR EFFORTS. THE CLINICAL TRIAL QUESTION, I REALLY THINK THAT THAT MAYBE POINTING OUT WHAT CLINICAL TRIALS ARE, AND WHAT MIGHT COME UP IN FUTURE TREATMENT OPTIONS MIGHT BE GOOD. THE ONE AREA WHERE SOME OF THE CLINICAL PAIR, AND DEVELOPMENT OVERLAPS A BIT IS IN EXPAND ED AND COMPATIBLE USE. AS A CLINICAL CARE PROCESS, NOT SO MUCH A RESEARCH PROCESS. I DON'T KNOW IF THE GUIDELINES HAVE EVER GOTTEN INTO YOU KNOW, THE ISSUE OF COMPASSIONATE USE APPLICATIONS. OR EXPANDED ACCESS PROGRAMS. >>>WE HAVE FEATURED INFORMATION ON THEM IN THE PAST. AGAIN, WE LOOK FOR INFORMATION THAT IS USEFUL TO PROVIDERS. PROVIDERS HAVE A HARD TIME FINDING THE INFORMATION THAT YOU MENTIONED. IT IS MORE OF AN ISSUE IN THE PAST THAN IT IS NOW. >>WE APPRECIATE WHAT YOU SAID ABOUT THE AMOUNT OF TIME IT TAKES. THE QUESTION WE DEAL WITH IN ALL OF OUR LIVES, WHAT DO WE HAVE THE TIME TO DO WELL, IF WE EXPAND TO DO THAT, CAN WE DO THAT WELL? THAT IS A CONSTANT STRUGGLE. >>I HEAR YOU. >>JUST ECHOING WHAT MARY, IF THERE ARE ANY QUESTIONS OR COMMENTS, FROM THE ADVISORY AS IT RELATES TO THE FEEDING GUIDELINES, THAT WE DIDN'T HAVE TIME FOR, WE CAN OPEN IT FOR DISCUSSION NOW. LUIS. >>A QUICK ONE. WE HAVE A COUPLE OF EMPTY SAYS, HAVE YOU BEEN ABLE TO EVALUATE THE READS FROM THE U.S. VERSUS INTERNATIONAL? OTHER CONDITIONS RAISED THE QUESTION. YOU ARE SERVING A BROADER AUDIENCE. >>WE HAVE. THE U.S. IS THE NUMBER ONE USER OF OUR GUIDELINES. THERE ARE USERS FROM AROUND THE WORLD. NO QUESTION. HENRY, YOU CAN PROBABLY COMMENT ON THE FACT THAT YOUNGER PROVIDERS HAVE NOT SEEN A CASE BEFORE, MAKING THE GUIDELINES RELEVANT ALL OVER AGAIN. >>IT IS TRUE, I MEAN, WE THINK THAT AS OLDER PROVIDERS, WE HAVE SEEN MANY OF THE DISEASES. TRIP SAYS, THERE ARE PEOPLE WHO NEED TO LOOK AT -- MAKING IT INTERNATIONAL, IS A COMPLEX ISSUE. FOR A U.S. GOVERNMENT AGENCY, WE HAVE TO BE CAREFUL ABOUT NOT TREADING ON OTHERS' TOES WHEN WE DON'T KNOW THE SITUATIONS IN OTHER COUNTRIES. IT IS DIFFICULT TO DEAL WITH ALL THE COUNTRIES OUT THERE, TO SAY SOMETHING IRRELEVANT. WE HAVE LARGELY U.S. PROVIDERS. UNLESS WE ASK FOR A COLLABORATIVE AGREEMENT WITH OTHER COUNTRIES, AND PUT THEM ON HERE, IT IS HARD TO GIVE GUIDANCE FOR OTHER PLACES. IT WOULD MAKE THEM TREMENDOUSLY MORE. >>I WASN'T SUGGESTING THAT A GLOBAL GUIDELINES, I WAS TRYING TO GET A SENSE AS TO YOUR AUDIENCE. AS TO WHO ACCESSES. HOW MUCH IS U.S. VERSUS INTERNATIONAL. >>THAT IS AN IMPORTANT ISSUE. ALEX POWELL LOOKS AT THIS CAREFULLY FOR ALL THE GUIDELINES. >>MAYBE YOU CAN JUMP IN QUICKLY TO MENTION THAT WE DO LOOK AT THE METRIC FORS PAGE VIEWS AND DIFFERENT VIEWS BY LOCATION. WE HAVE THAT DATA. WE WOULD BE HAPPY TO SHARE WITH YOU. IT DOES BARE ON THE TYPE OF GIAN ARE YOU LOOKING AT. NATIONAL GUIDELINES FOR ARVs, MORE PREVALENT. WE DO HAVE A NUMBER OF INTERNATIONAL HITS, IF YOU WILL FOR THE OI GUIDELINES. WE DO FOR ALL OF THEM. THOSE IN PARTICULAR. >>THAT IS AN INTERESTING QUESTION ABOUT THE INTERNATIONAL VIEWS. I THINK NAWOULD BE INTERESTING TO SEE WHAT DETAILS ON THAT. AND I JUST, AGAIN, GOING BACK TO THE WORKSHOP, THAT IS STILL FRESH IN MY MIND. THE ISSUE OF FACILITATING. I AM NOT SAYING ABOUT ANY OF HER PEOPLE INVOLVED, IT MAY MAKE AN INTERESTING, YOU KNOW, THESIS FOR A STUDENT. TO HOOK AT WHAT MEKS TENT THE GUIDELINES HAVE BY THIS PANEL. BY THIS FEDERAL -- AS A RESEARCH TOPIC. BRAIN STORMING HERE ABOUT IT. WE SAY THE HELP. HCB, I THINK IT BECAME CLEAR, I WONDER IF IT WOULD BE AN INTERESTING RESEARCH TOPIC FOR A STUDENT AT SOME POINT. >>THANK YOU AGAIN, FOR THE IDEA. I THINK OUR COLLEAGUES, I WANT TO MAKE SURE, WE HAVE ABOUT 10 MINUTES LEFT IN THE SCHEDULE IF THERE ARE ANY OTHER THOUGHTS AND COMMENTS WE CAN MAKE. HANDS ARE GOING UP. I AM GOING TO GO WITH DR. METTA FIRST, AND WE WILL COME BACK TO YOU. >>I AM GOING TO GO BACK TO THE COMMENT I WANTED TO MAKE EARLIER, THANK YOU FOR THE PRESENTATIONS TODAY. MY COMMENT AND QUESTION WAS FOR DR. MILLER'S PRESENTATION. I WAS EXCITED TO SEE ALL OF THE PRESENTATIONS, IN PARTICULAR, THIS ONE, IT HIGHLIGHTED THE SYSTEMATIC INCLUSION OF THOSE WHO INJECT AND DRUGS, PREVENTION TRIALS, RAISED AT CROIX THIS YEAR. PEOPLE WHO USED INJECT DRUGS WERE NOT INCLUDED IN THE LONG-ACTING PREP TRIALS. WE DON'T HAVE THAT EVIDENCE BASE. YOU HAVE EXCELLENT RECOMMENDATIONS AND GREAT EXAMPLES I WORRY WE KEEP MAKING THE SAME MISTAKES IN THE EARLY FACES, IN TERMS OF SAFETY, AND THE EARLY TRIALS. HOW DO WE, AS NEW INNOVATIONS COME DOWN THE PIKE, A DIFFICULT QUESTION, ENSURE THAT POPULATIONS, INCLUDE PEOPLE WHO STAND TO BENEFIT FROM THE INTERVENTIONS. >> YOU ARE SO RIGHT. THANK YOU FOR RAISING THAT. PREVENTION AND PARTIES ARE STARTING TO OVERLAP A LOT MORE. OBVIOUSLY, THEY ARE SEPARATE IN MANY WAYS, I THINK WHEN PEOPLE DO TREATMENTS AND TRIALS -- YOU KNOW, THERE WAS A TRIAL IN THAILAND THAT WAS FOR INJECTION DRUG USERS. >>IT WAS ORAL PREP. MOST OF WHAT THEY FOCUS ON, IS THERE HIGH ENOUGH INCIDENTS, TO SEE A DECREASE. THEY ARE NOT UNIFORM. THEY MIGHT BE INJECTING, MAYBE FOR WOMEN, IN DIFFERENT SETTINGS. I THINK THAT IS WHY SOME OF THE RURAL SETTINGS, WHERE YOU SEE THE HOT SPOTS OF HIV INCIDENTS, DON'T -- IT WOULD BE SO IMPORTANT TO STUDY AND PREP AS WELL. I THINK THAT IT IS THE LONG ACTING MOLECULE, USE IT FOR PREVENTION OR TREATMENT. THERE SHOULD BE MORE OVERLAP THERE, AND LESSONS LEARNED ON THE SAFETY SIDE. IN BOTH PROGRAMS. I SO AGREE WITH YOU. WE NEED TO TALK WITH THE SPONSORS AND THE COMMITTEES ABOUT HOW TO INCREASE DIVERSITY AND INCUBATION TRIALS. >>I WILL GO TO JONATHAN NEXT. >>CAN YOU HEAR ME OKAY? >>WE CAN. >>I WILL SAY THAT THE VIDEO GREMLIN TOOK OVER MY CAMERA. I DIDN'T WANT TO SIGN OUT AND MISS SOMETHING, AND SIGN BACK IN. OTHERWISE, I WOULD BE SHOWING MY FACE. THIS HAS BEEN A GREAT MEETING. I WANTED TO APPRECIATE ALL THE COMMENTS FROM FOLKS, ONE QUESTION, I THINK FOR THE GROUP. MAYBE FOR ONE IN PARTICULAR. A LOT OF WHAT WE HAVE BEEN BRINGING UP IN THE CONCEPT, HOW DO WE DO A BETTER JOB WITH HOLISTIC AND APPROACHES, AND ACROSS BARRIERS, SOME OF IT RELATES TO POPULATIONS, WOMEN, OR TRANSGENDER GROUPS WHO USE DRUGS. I WANT TO CARE FOR SOMEONE'S HIV, BUT THOSE LIVING WITH HIV. I THINK THAT BROAD PICTURE I HAD IS HOW DO WE DO THAT? IS ON. AR CAPABLE OF SUPPORTING AND USING RESOURCES FOR THOSE KINDS OF CROSS-DISEASE APPROACHES, OR DO THEY FEEL LIMITED BY LAW NOT TO USE THEM? SOMETHING WE HAVE BEEN THINKING ABOUT AS BEING AN OPTION AT THE CDC, A LOT OF OUR INFECES ARE CHRONIC INFECTIOUS DISEASES, THE DIAGNOSIS IS OFTEN DELAYED, AND PROBABLY BETWEEN HIV, 15%, HEP C, 14%, HEP C, OR PEOPLE WHO DON'T KNOW THEIR STATUS. GET TESTED. IT IS AN EXTRA STEP THAT WILL PREVENT IT FROM OCCURRING. IF THERE IS A SYSTEM IN PLACE, FOR ANTIBODIES OR BOTH, I WENT TO THE DOCTOR, IN THE ER. THEY ORDERED 90/20, AND 20 PICKING UP CHRONIC INFECTIONS, WE WOULD GREATLY BENEFIT. IT WOULDN'T BE HIV-SPECIFIC. I WONDER IF THERE IS A SCOPE FOR THAT OR DO CHANGES NEED TO BE MADE? MARR EEP, I BELIEVE THE QUESTION WAS TO YOU. I WILL GIVE YOU AN OPPORTUNITY TO COMMENT IF YOU HAVE ONE. >>YOU ALWAYS ASK THE GREAT QUESTIONS. I THINK WHAT YOU ARE TALKING ABOUT IN TERMS OF LOOKING AT ISSUES MORE THAN JUST HIV, IN CONSIDERABLE PROPOEGZ WITH PEOPLE WHO HAVE HIV WHO HAVE OTHER CONDITIONS, COLON INFECTIONS OR COMORBIDITIES, IS IT SCIENTIFICALLY JUSTIFIABLE AS PART OF IT, I WOULD SAY YES, DEPENDING ON HOW THE TERMS AND THE QUESTIONS ARE DEVELOPED. FOR THE FUNDING AND THE SUPPORT. THERE IS A LOT OF WAYS TO LOOK AT PREVENTION AND PARTICULARLY TREATMENT OF PEOPLE WITH HIV, AND THEIR COMORBIDITIES AND COINFECTIONS ANDANCEULARY ISSUES THAT CAN COMPLICATE THEIR CARE AND TREATMENT. IT IS NOT NECESSARILY EXCLUSIVE. THE RECURRING PROBLEM OR CHALLENGE, IT WAS A PROBLEM BEFORE I WAS THE DIRECTOR. IT IS HOW DO YOU DEFINE THESE AREAS? IT IS SOMETHING THAT WE GRAPPLE WITH. IF THERE WERE LIMITLESS FUNDS, THERE COULD BE LIMITLESS WAYS. ON THE INCREASING INVOLVE, HOW WE DEPLOY THE RESOURCES, THE ONE OF THE QUESTIONS THAT YOU GRAPPLE WITH, IT MAY BE A GOOD QUESTION FOR OARAC IN THE FUTURE, HOW MANY DEGREES ARE THERE, IMPORTANT SCIENCE, NOT INTIMATELY RELATED TO HIV. >>I AM APPRECIATING YOUR EXPERIENCE. >>THANK YOU FOR THE QUESTION. >>WHAT IS THE POSITION OF THE COMMITTEE, PRIMARILY FOR THE SUPPRESSED, THERE HAS BEEN A LOT OF DISCUSSION ABOUT THE POPULATIONS WHO THE GAIN WILL MOST MAY NOT HAVE SUSTAINED SUPPRESSION, AND HAVE THIS FOR AN ALTERNATIVE. I DON'T KNOW WHAT THE GUIDELINES COULD CHANGE. THERE MAY BE A GAP BETWEEN PROVIDERS LOOKING FOR THIS OPTION, AND THE INDICATION COMING OUT FOR IT. DOES THE GUIDANCE COMMITTEE TAKE A POSITION? >>WE, LIKE PRACTICING PHYSICIANS, CAN INCLUDE OFF LABEL -- WE ARE NOT BOUND BY THE FDA, WE WOULD CONSIDER THEM CAREFULLY. MORE IMPORTANTLY, WE ARE LOOKING FOR DATA TO SUPPORT OUR RECOMMENDATIONS. ANEC DOTTA DATA IS JUST THAT. WE ARE LOOKING FOR MORE DATA TO SUPPORT RECOMMENDATIONS. YES, THERE ARE TIMES THAT WE HAVE MADE A RECOMMENDATION THAT IS OFF LABEL USE OF THE MEDICATION. >>THANK YOU. MONICA, THE LAST QUESTION. >>JUST TO RESPOND. WHAT IS CONSIDERED ANECDOTAL AND A PROJECT THAT IS ENOUGH? DO YOU HAVE A NUMBER IN MIND THAT PEOPLE FLEEDED TO TREAT, 133 PEOPLE, WELL, NOW WE HAVE MORE. WHAT IS IT IS BEING REVIEWED AS A MANUSCRIPT, I KNOW THAT IS SMALL, SO, ABOUT 57 PEOPLE. WHAT KIND OF NUMBERS, IS THAT SOMETHING YOU HAVE TO MEET AND DISCUSS. WHAT DATA WOULD IT TAKE FOR THE GUIDELINES TO SAY, NOT A GRADE A RECOMMENDATION, BUT SOMETHING THAT PEOPLE ARE TRYING, EASIER FOR THEM TO GET EXPERIENCE TO DO THAT, THE GUIDELINES COMMITTEE STATEMENT ABOUT IT. >>WE LOOK AT THE TOTALITY OF THE DATA, AND THE HIGHEST LEVEL, OF COURSE, A RANDOMIZED CLINICAL TRIAL, DONE AT MULTIPLY PEL INSTITUTIONS, AND SHOWS A RESULT, TWO AT MULTIPLE U.S. INSTITUTIONS. WE HEAR CASE REPORTS, AND LEVIEW THE DATA. CLEARLY, SOME DATA ARE STRONGER THAN OTHERS, AND MORE INFLUENTIAL FOR GUIDELINES. A SINGLE CENTER REPORT OF A GROUP OF PATIENTS, WEST COAST CITY THAT HAS A GOOD RESULT, CERTAINLY IS SOMETHING TO DISCUSS. WHETHER IT IS POWERFUL ENOUGH TO CHANGE GUIDELINES MERITS DISCUSSIONS. >>THANK YOU. >>>THIS, THIS TURNED INTO A REALLY RICH DISCUSSION. WE WILL MOVE ALONG NOW IN THE AGENDA, THIS IS THE TIME THAT WE A LOT FOR PUBLIC COMMENT. MARY, DO YOU -- DID YOU RECEIVE ANY PUBLIC COMMENTS? >>AS A MATTER OF FACT, WE DO HAVE ONE. I WILL GO AHEAD AND SHARE THAT WITH YOU NOW. THIS IS FROM MR. JULES LEIN, NATIONAL AIDS ADVOCACY. THANKS FOR LISTENING TO THE CONCERNS VOICED AROUND HIS PROBLEM. HE KNOWS THERE ARE CONCERNS THAT REMAIN ON THE MAT. MR. LEVIN STATES THAT AGING WITH HIV IS A MAJOR PROBLEM FOR PERSONS WITH HIV OVER 50, AND PARTICULARLY THOSE OVER THE AGE OF 65. HE KNOWS THAT FOR OLDER PERSONS WITH HIV, THEY MAY SUFFER FROM EARLIER ON-SET AND COMORBIDITIES, AND MULTIPLE COMORBIDITIES. HE KNOWS THAT ALZHEIMER'S RISK MAY BE INCREASED. PEOPLE OVER 65 WITH UNSET CARE NEEDS, THE NEED FOR GERIATRIC SCREENINGS ARE NOT PERFORMED OFTEN IN HIV CLINICS, AND HIV CARE IS NOT OFTEN PROVIDED IN GERIATRIC CLINICS. THESE ISSUES CAN RESULT IN IMPAIRMENT AND PREMATURE DEATH. HE ACKNOWLEDGES THE BROAD NIHESTS, AND EMPHASISES THE NEED TO GO BEYOND SCIENCE. INNOVATIVE RESEARCH TO, SUPPORT THE CLINICAL CARE OF EARLY WITH HIV. HE STATES THAT HIV ADVOCACY COMMUNITY HAS BEEN DISCUSSING THIS, HAVING DIRECT DISCUSSIONS WITH THE OARAC, AND HE NOTES THAT HE AND OTHER ADVOCATES WOULD LIKE TO PARTICIPATE IN WHAT WAS DISCUSSED EARLIER TODAY. AND WITHIN THE ACTG, AND ADVOCATES FOR 34R EDUCATION THROUGH THE NETWORK. THE ACTG FUNDING, AND ATTENTION TO PROVIDE QUALITY CARE FOR THOSE WHO ARE PERNATALLY INFECTED. THAT CLON CLUDES THE PUBLIC COMMENT. I WOULD LIKE TO THANK A MOMENT TO THANK YOU AS THE CHAIR, THIS IS YOUR LAST MEETING AS CHAIR. WE HOPE TO HAVE YOU BACK IN OTHER CAPACITIES IN THE FUTURE. IT HAS BEEN MY PLEASURE TO WORK WITH YOU. THANK YOU. >>THANK YOU, MARY. BEFORE I HAND IT OVER TO MAUREEN, I WOULD LIKE TO SAY THAT THE PAST TWO YEARS HAVE BEEN QUITE YOU KNOW, A LEARNING EXPERIENCE FOR ME. SOMEONE COMING IN WHO IS A BASIC SCIENTIST TO THINKS OF THE MOLECULES OF THE VIRUS, HOW TO SLOW DOWN PROGRESSION AND MOLECULAR LEVEL. I GAINED A LOT FROM SERVING AS CHAIR OF THE OARAC FOR THE PAST TWO YEARS, AND I WANT TO END ON, ONE OF THE THINGS THAT I LEARNED AND APPRECIATED IS THAT YOU KNOW, THE COOPERATION, AND CONVERANCE AND CLINICAL TRIALS, PUBLIC ENCOURAGEMENT, I HAVE HEARD A LOT ABOUT IT OVER THE LAST TWO YEARS, IT HAS BEEN GREAT. I WILL CAST IT OVER TO MAUREEN. >>OKAY, WELL, THANK YOU VERY MUCH TO EVERYONE, BLANTON, I WANT TO SAY AWE FEW WORDS ABOUT YOUR TENURE AS OARAC CHAIRS, YOU ARE UNIQUE, IN THE SENSE THAT YOU ARE THE FIRST CHAIR TO HAVE TO RUN VIRTUALLY THROUGH THE ENTIRE TIME OF YOUR TENU, VIRTUAL MEETINGS, YOU WE HAVE NEVER DONE BEFORE. YOU HAVE BEEN INCREDIBLY TALENTED IN HOW YOU CAN. UDOS TO YOU FOR A FANTASTIC JOB AS CHAIR. OF THE OARAC, AND ALL THE NEW POSITION WITH THE HOWARD HUGHES INSTITUTE. I SHOULD POINT OUT THAT WE HAD TRIP GULICK TODAY, AND JEN, THEY HAVE ALL BEEN CHAIR. YOU NEVER ESCAPE, ONCE YOU HAVE COME IN TO THAT CATEGORY. I AM GLAD YOU WILL SPEND PART OF YOUR TIME IN D.C., WE HAVE LUNCH. I AM EXCITED LOOKING TO THE JUNE MEETING. HOPEFULLY, WE CAN PULL OFF AT LEAST A HYBRID. AND HAVE SOME OF YOU COME INTO TOWN. IF NOT A LOT OF YOU. I CAN'T SAY SAFE TRAVELS, SINCE YOU ARE PROBABLY ALL IN YOUR HOMES AT BEST. WE DO THANK YOU VERY MUCH AND APPRECIATE ALL OF THE INPUT, AND CONTINUED CONVERSATION. NO REASON WHY WE CAN'T TALK TO EACH OTHER IN BETWEEN TIMES. IF YOU HAVE AN IDEA. POP IT ALONG. IF WE NEED TO GET INFORMATION QUICKLY, WE HAVE A HUGE RESOURCE IN THE PEOPLE ON THE COMMITTEE. AND ALL OF THE DIFFERENT CAPACITIES IN WHICH YOU FUNCTION. THANK YOU AND HAVE A GREAT DAY.