>> DISCUSSION OF A SPECIFIC PROGRAM OR PROJECT FOR WHICH THEY HAVE A REAL OR APPARENT CONFLICT OF INTEREST. IS A PROGRAM DISCUSSED PRESENTS A CONFLICT, EXCUSE YOURSELF FROM THE ROOM, THERE'S A CONFLICT OF INTEREST FORM IN YOUR MEETING FOLDER ON THE TABLE, IF YOU COULD PLEASE SIGN AND RETURN TO THE OAR STAFF AT THE RECEPTION DESK BY THE END OF THE DAY IT WOULD BE GREATLY APPRECIATED. I'LL TURN THE MEETING OVER NOW TO DR. MONICA GANDHI. >> OKAY, GOOD MORNING. 47th MEETING IS NOW IN SESSION. I'D LIKE TO WELCOME THE COUNCIL MEMBERS AND GUESTS IN THE AUDIENCE. WE'LL BEGIN WITH EVERYONE AT THE TABLE INTRODUCING THEMSELVES. ACTUALLY WE'LL START WITH DR. TOLBERT AND GO AROUND. >> BLANTON TOLBERT, CASE WESTERN RESERVE, MY LAB STUDIES STRUCTURAL BIOLOGY OF HIV TRANSCRIPTION AND SPLICING. >> DICK CHASE, JOHNS HOPKINS, RUN THE CENTER FOR TB RESEARCH AND CENTER FOR AIDS RESEARCH AT HOPKINS. >> GOOD MORNING, GEN CATES, KAISER FAMILY FOUNDATION IN WASHINGTON, D.C. OFFICE, I DIRECT GLOBAL HEALTH AND HIV POLICY WORK. >> KIM SCARSI, COLLEGE OF PHARMACY, UNIVERSITY OF NEBRASKA. >> (INDISCERNIBLE) NORTHWESTERN, CHICAGO. >> BRUCE SHACKMAN, PROFESSOR AT WILE CORNELL AND NIAIDA FUNDED RESEARCH. >> LYNN MOFENSON, PEDIATRIC SPECIALIST WITH THE ELIZABETH GREATER FOUNDATION. >> STEPHANIE, ASSOCIATE DEAN THE GLOBAL HEALTH SERVICE UC SAN DIEGO. >> GOOD MORNING, RALPH DECLEMENTE, PROFESSOR OF PUBLIC HEALTH EMORY UNIVERSITY, SCHOOL OF PUBLIC HEALTH. >> ALLEN GREENBERG, GEORGE WASHINGTON UNIVERSITY, DIRECTOR OF THE DISTRICT OF COLUMBIA CENTER FOR AIDS RESEARCH. >> LINDA DEAN, HOME ORGANIZATION IS AIDS ACTION BALTIMORE, ALSO WITH THE AIDS TREATMENT ACTIVIST COALITION AND SPENDING MOST OF MY TIME LATELY ON THE MARTIN DELANEY CAB, A CURE RESEARCH AS WELL AS DARE AND AMFAR CURE INSTITUTE. >> GOOD MORNING, JONATHAN MERMAN, DIRECTOR OF NATIONAL CENTER FOR HIV VIRAL HEPATITIS SEXUALLY TRANSMITTED DISEASE AT THE CENTERS FOR DISEASE CONTROL. >> TRISH BURDO, ASSOCIATE PROFESSOR AT TEMPLE UNIVERSITY, DEPARTMENT OF NEUROSCIENCE. >> GOOD MORNING, CHUCK LURE, SCHOOL OF MEDICINE AT DARTMOUTH, PROFESSOR WORKING ON MUCOSAL IMMUNITY AND HETEROSEXUAL TRANSMISSION OF HIV. >> MARGARET BRANDO, PROFESSOR OF MANAGEMENT SCIENCE AND ENGINEER AND PROFESSOR OF MEDICINE AT STANFORD UNIVERSITY, POLICY MODELS FOR HIV AND DRUG ABUSE. >> LIZ CONNICK, CHIEF OF INFECTIOUS DISEASE UNIVERSITY OF ARIZONA, HIV RESEARCH. >> CARL DIEFFENBACH, DIRECTOR OF DIVISION OF AIDS. >> SCOTT RHODES, WAKE FOREST SCHOOL OF MEDICINE, WORK AROUND LATINO COMMUNITIES AND I ALSO DIRECT A PROGRAM IN COMMUNITY ENGAGEMENT. >> JONAS SASHA, OREGON HEALTH SCIENCE UNIVERSITY, PORTLAND, OREGON, I WORK ON PRE-CLINICAL VECTOR DEVELOPMENT AND UNDERSTANDING HOW TIMOTHY BROWN WAS CURED VIA STEM CELL TRANSPLANT IN NON-HUMAN PRIMATES. >> I'M INGRID BASSETT, ASSOCIATE PROFESSOR HARVARD MEDICAL SCHOOL INFECTIOUS DISEASE PHYSICIAN AND DO MAINLY IMPLEMENTATION SCIENCE RESEARCH, SUB-SAHARAN AFRICA. >> JULIE ACHE, MILITARY HIV PROGRAM, WALTER REED. >> JOHN CHEN, HUNTER COLLEGE, CITY UNIVERSITY OF NEW YORK, URBAN POLICY AND PLANNING DEPARTMENT, I DO HIV SOCIAL SCIENCE RESEARCH. >> DR. DAN KROTSKUS IS JOINING US BY PHONE. HE'S NOT, OKAY. THE FIRST ORDER OF BUSINESS TO APPROVE THE BUSINESS FROM THE NOVEMBER 16 MEETING, AND YOU SAW YESTERDAY THAT THEY WERE SENT OUT ELECTRONICALLY AGAIN AFTER A FEW CORRECTIONS. SO YOU SHOULD HAVE RECEIVED THEM VIA E-MAIL. THERE'S A COPY IN THE OAR WEBSITE. SO I WANT TO SEE IF THERE'S A MOTION TO APPROVE THE MINUTES. AND SECOND, FOR THE MINUTES. OKAY. ALL RIGHT. SO ALL IN FAVOR. OKAY. TODAY'S MEETING IS GOING TO INCLUDE A REPORT FROM DR. GOODENOW, REPORT OF THE OAR DIRECTOR, REVIEW THE PANEL ACTIVITIES FOR THE HIV TREATMENT AND PREVENTION GUIDELINES, UPDATES ON THIS NIH AIDS STUDY SECTIONS, WE'LL TALK ABOUT THE OAR COST SHARING TASK FORCE AND THE WORK OF THAT WILL BE PRESENTED TODAY. AND THEN WE WILL -- GINA BROWN WILL GO OVER THE 2019/20 TRANS-NIH STRATEGIC PLAN FOR HIV AND HIV-RELATED RESEARCH. AND HIV RESEARCH ACTIVITIES FROM THE NATIONAL CANCER INSTITUTE, OFFICE OF RESEARCH INFRASTRUCTURE PROGRAMS, AND NATIONAL INSTITUTE OF MENTAL HEALTH. THE AGENDA WILL INCLUDE TIME AT THE END FOR FORMAL PUBLIC COMMENT, SO IF ANYONE WISHES TO MAKE A PUBLIC COMMENT WHO IS ON THE PHONE WE ASK THAT YOU NOTIFY OAR STAFF BY PROVIDING NAME AND AFFILIATION PRIOR TO THE PUBLIC COMMENTS SECTION OR WHO IS HERE, OUTSIDE THE CONFERENCE ROOM. AND THE ALLOTTED TIME IS FOR BRIEF STATEMENTS, NOT FULL PRESENTATIONS. SO THANK YOU. DR. GOODENOW, THE DIRECTOR OF THE OFFICE OF AIDS RESEARCH, WILL NOW BRIEF US ON THE COUNCIL. >> WELL, GOOD MORNING. I'D LIKE TO GIVE A WARM WELCOME TO THE COUNCIL MEMBERS. WE REALLY APPRECIATE YOUR DEDICATION AND YOUR SERVICE TO THE OAR AND TO THE NIH. I WOULD LIKE TO THANK ALL PARTICIPANTS FROM PROFESSIONAL AND LAY ORGANIZATION ATTENDING TODAY, OTHER MEMBERS AND COLLEAGUES FROM THE NIH AND ALL THOSE WHOSE INTEREST AND ACTIVITIES ALIGN WITH THE MISSION OF THE NIH OFFICE OF AIDS RESEARCH. I ALSO WANT TO MAKE A COMMENT ABOUT THIS WONDERFUL NEW PODIUM BECAUSE I DON'T KNOW, FOR THOSE WHO DON'T RECALL, FOR SHORT PEOPLE LIKE MYSELF WE USED TO HAVE TO LOOK OVER THE EDGE. THERE WERE PEOPLE WHO WOULD SPEAK AND YOU COULDN'T EVEN SEE THEM. THIS IS DEFINITELY AN IMPROVEMENT. KUDOS TO THE ORGANIZING OR WHOEVER DID THIS. GREAT. OKAY. LET'S SEE HOW THIS WORKS. WHAT I'M GOING TO START WITH IS THE OARAC UPDATE. WE ACTUALLY HAVE FOUR OF OUR MEMBERS WHOSE TERMS END IN THIS CYCLE. AND THAT INCLUDES DR. MONICA GANDHI, WHO HAS BEEN A MAGNIFICENT WONDERFUL CHAIR FOR THE LAST FOUR MEETINGS. DR. MOISES AUGUSTA ROSARIO, WHO IS THE DIRECTOR OF TREATMENT AT THE NATIONAL MINORITY AIDS COUNCIL. DR. RALPH DECLEMENTE, PROFESSOR AT ROLLINS SCHOOL OF PUBLIC HEALTH AT EMORY, AND DR. DAN KURITZKEK FROM HARVARD MEDICAL SCHOOL. YOU WERE INVOLVED WITH OARAC BEFORE I BECAME DIRECTOR, HAVING YOU HERE WHILE I WAS GETTING USED TO THE SYSTEM AND BRINGING ON NEW MEMBERS AND WONDERFUL HELP AND I REALLY APPRECIATE THE FACT YOU GUYS ACTUALLY VOLUNTEERED TO EXTEND YOUR SERVICE BY AN EXTRA SIX MONTHS WHILE WE WERE GOING THROUGH THE TRANSITION OF GETTING NEW MEMBERS AND STAYING ON SO WE HAD A QUORUM AND WERE ABLE TO CONTINUE DOING OUR ACTIVITIES. THANK YOU VERY MUCH. YOU MAY BE FORMAL OFF, WE KNOW WHERE YOU ARE. SPECIAL WELCOME TO OUR NEW VOTING MEMBERS, DR. ELIZABETH CONNICK, WHO YOU JUST HEARD IS PROFESSOR OF MEDICINE AT THE UNIVERSITY OF ARIZONA, AND DAZEON DIXON DIALLO, PRESIDENT OF SISTER LOVE, EXPERTISE IN COMMUNITY BASED RESEARCH, HIV RESEARH AND WOMEN. JUST AS A QUICK REMINDER, COUNCIL MEMBERS TODAY ARE UNABLE TO ATTEND, BUT WE DO HAVE A QUORUM. WE HAVE AD HOC SOME NEW AD HOC MEMBERS, INDIVIDUALS NOMINATED TO BE ON OARAC, IN THE PROCESS OF GOING THROUGH CLEARANCE AND APPROVALS INTO HHS. I'D LIKE TO WELCOME DR. MARGARET BRANDO, WHO IS FROM STANFORD UNIVERSITY, WITH EXPERTISE IN MATHEMATICAL AND ECONOMIC MODELS FOR HEALTH POLICY DECISION MAKING. DR. HEIDI CRANE FROM UNIVERSITY OF WASHINGTON WITH EXPERTISE IN BEHAVIOR AND SOCIAL SCIENCES, RELEVANT TO HIV/AIDS, CLINICAL CARE AND INFECTIOUS DISEASE AND DR. WILLIAM POWDERLY, CO-DIRECTOR, DIVISION OF INFECTIOUS DISEASE AT WASHINGTON UNIVERSITY. SCHOOL OF MEDICINE, COMPLICATIONS OF ANTIRETROVIRAL. THE AD HOC MEMBERS INCLUDE JONAS SAKKA, ASSOCIATE PROFESSOR AT VACCINE AND GENE THERAPY INSTITUTE, WITH EXPERTISE IN MOLECULAR BIOLOGY, IMMUNOLOGY, NON-HUMAN PRIMATE ANIMAL MODELS, DR. DAVID SMITH FROM UNIVERSITY OF CALIFORNIA SAN DIEGO AND DR. TOLBERT, CASE WESTERN RESEARCH, EXPERT IN STRUCTURAL BIOLOGY, MOLECULAR BIOLOGY AND RETROVIROLOGY. AND YOU ALSO HEARD THIS MORNING AN INTRODUCTION THAT THE DOCTOR FROM THE U.S. MILITARY HIV-INFECTED RESEARCH PROGRAM IS ATTENDING TODAY, AS THE DESIGNEE OF OUR EX OFFICIO MEMBER DR. NELSON MICHAEL. THANK YOU ALL FOR BEING HERE AND FOR WHAT IS GOING TO BE A REALLY THINK VERY BUSY DAY WITH A LOT OF INTERESTING INFORMATION. THE UPCOMING OARAC MEETINGS IN 2018 THURSDAY JULY 12 WEB-BASED MEETING, THURSDAY NOVEMBER 16, THOSE ARE THE 2018 MEETINGS. THIS SCHEDULE NOW INCLUDES THREE MEETINGS WITH ONE OF THEM BEING A TELECONFERENCE IN JULY. I IMPLEMENTED THREE ANNUAL OARAC MEETINGS IN FY17 WHICH IS MY FIRST FULL YEAR AS DIRECTOR, STARTING IN 2019 THE THREE ANNUAL OARAC MEETINGS WILL CONTINUE BUT THEY ALL THREE WILL BE IN-PERSON MEETINGS. TODAY'S MEETING PRECEDED BY A TELECONFERENCE TO PROVIDE OARAC MEMBERS OVERVIEW ABOUT AGENDA ITEMS AND ANSWER PROCEDURAL QUESTIONS. OAR WILL CONTINUE TO ORGANIZE PRE-MEETING TELECONFERENCES GOING FORWARD. STARTING IN NOVEMBER 2018, OAR WILL PROVIDE ON AN ANNUAL BASIS A HALF DAY IN-PERSON ORIENTATION WORKSHOP FOR THE OARAC. THE GOAL FOR THE WORKSHOP IS TO PROVIDE OVERVIEW OF ROLES AND RESPONSIBILITIES OF THE OAR, VARIOUS TYPES OF INPUT THAT OAR CAN RECEIVE IN THE FORM OF COMMITTEES, WORKING GROUPS, TASK FORCES, REQUESTS FOR INFORMATION, COORDINATING COMMITTEES, OARAC AND NIH AIDS EXECUTIVE COMMITTEE, FOR EXAMPLE. THE WORKSHOP WILL REVIEW PROCESSES FOR OAR TO SYNTHESIZE INFORMATION, HOW OAR DEVELOPS AND PROCESSES POLICIES IN NIH LEADERSHIP AND HOW OAR ACHIEVES ITS MISSION AS COORDINATOR OF THE TRANS-NIH HIV RESEARCH PORTFOLIO. MOST IMPORTANTLY FOR THE ORIENTATION IS HOW OARAC MEMBERS CONTRIBUTE TO NIH VISION, POLICIES AND RESEARCH TO END THE NIH PANDEMIC AND IMPROVE THE HEALTH OF PEOPLE LIVING WITH HIV. I NOW WANT TO REVIEW SOME OF THE KEY APPOINTMENTS THAT HAVE GONE ON WHICH ARE DEFINITELY IMPORTANT FOR OAR AND FOR THE OARAC. AT THE END OF JANUARY, ALEX AZAR WAS SWORN IN AS SECRETARY OF HHS, SPENT A CAREER IN PUBLIC AND PRIVATE SECTOR AS ATTORNEY, AND SENIOR LEADERSHIP HEALTH CARE REFORM AND INNOVATION, REPLACING DR. THOMAS PRICE WHO RESIGNED IN 2017. MR.AZAR SERVED AT HHS IN THE PAST FROM 2001 TO 2007 AS GENERAL COUNSEL AND DEPUTY SECRETARY. DURING HIS TERM AS DEPUTY SECRETARY, MR. AZAR WAS INVOLVED IN IMPROVING DEPARTMENT OPERATIONS BY ADVANCING ITS EMERGENCY PREPAREDNESS AND RESPONSE CAPABILITIES, GLOBAL HEALTH AFFAIRS ACTIVITIES, AND HELPING TO OVERSEE THE ROLLOUT OF MEDICARE PART D PRESCRIPTION DRUG PROGRAM. IN 2007 MR. AZAR WAS SENIOR VICE PRESIDENT FOR CORPORATE AFFAIRS AND COMMUNICATIONS AT ELI LILLY AND COMPANY, FROM 2012 TO 2017 SERVED AS PRESIDENT OF LILLY USA LLC, THE COMPANY'S LARGEST AFFILIATE. GRADUATED WITH A BACHELOR'S DEGREE FROM DARTMOUTH COLLEGE, LAW DEGREE FROM YALE UNIVERSITY. AND LAST WEEK, YOU HEARD THAT DR. ROBERT REDFORD, MEDICAL DEGREE GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE, APPOINTED NEXT DIRECTOR OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION. HE REPLACES DR. BRENDA FITZGERALD WHO RESIGNED ON JANUARY 31, 2018. PRIOR TO HIS APPOINTMENT HE WAS DIRECTOR OF INSTITUTE OF HUMAN VIROLOGY AT THE UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE, CHIEF OF INFECTIOUS DISEASE AND VICE CHAIR OF MEDICINE FOR CLINICAL AFFAIRS. HE OVERSAW EXTENSIVE CLINICAL PROGRAM PROVIDING HIV CARE AND TREATMENT IN THE BALTIMORE-WASHINGTON COMMUNITY AS WELL AS PART OF PEPFAR. DR. REDFIELD SERVED AS MEMBER OF THE PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS FROM 2005 TO 2009, AND WAS CHAIR OF THE INTERNATIONAL SUBCOMMITTEE FROM 2007 TO 2009 AND SERVED ON THE OARAC IN 2002 TO 2005. THE ADVISORY BOARD OF THE NIH'S FOGARTY INTERNATIONAL CENTER AND ADVISORY ANTI-INEFFECTIVE COMMITTEE. THIS IS LIKE HAVING ONE OF OUR NEIGHBORS AND ONE OF OUR COLLEAGUES IN THIS REALLY IMPORTANT POSITION. SO IT'S VERY EXCITING TO HAVE THESE NEW APPOINTMENTS. THIS JUST GIVES AN OVERVIEW OF THE REST OF MY TALK AND TOPICS THAT ARE GOING TO BE COVERED. QUICK BUDGET UPDATE, AS YOU KNOW FRIDAY FINALLY WE WERE -- FY 2018 CONSOLIDATED APPROPRIATION ACT WAS SIGNED BY THE PRESIDENT, THAT PROVIDES GOVERNMENT FUNDING THROUGH SEPTEMBER 30, 2018, SO ALTHOUGH WE'VE GOT ALL BRIEFED ON HOW TO GO THROUGH A GOVERNMENT SHUTDOWN FORTUNATELY WE DIDN'T HAVE TO DO IT. WE'RE BUDGETED THROUGH THE END OF 2018 FISCAL YEAR AND WE'RE WORKING THROUGH THE 2,000-PAGE DOCUMENT TO SEE WHAT'S THERE. THE OAR SENIOR STAFF UPDATE, DR. PETER KIM, DEPUTY DIRECTOR THE FIRST OFFICIAL DEPUTY DIRECTOR FOR OAR, IS NOW THE DIRECTOR OF THE THERAPEUTICS RESEARCH PROGRAM IN THE DIVISION OF AIDS, NATIONAL INSTITUTE OF ALLERGIES AND INFECTIOUS DISEASES, AND WHILE THIS WAS A GREAT MOVE FOR DR. KIM, IT WAS TOUGH FOR US BECAUSE HE'S BEEN A FANTASTIC COLLEAGUE OVER THE PAST YEAR, CERTAINLY FOR MY BENEFIT HAVING SOMEONE WHO IS SO INTIMATELY INVOLVED IN THE NIH, KNOWS HOW THE NIH WORKS, IT WAS A FANTASTIC OPPORTUNITY FOR ME TO HAVE EXCELLENT GUIDANCE AND ADVICE. SO WE WISH DR. KIM WELL IN HIS NEW ENDEAVORS, AND DR. DIEFFENBACH FOR HIS NEW STAFF. WE ARE IN RECRUITMENT MODE, I'M HAPPY TO SAY. WE'VE BEEN APPROVED TO RECRUIT A NEW DEPUTY DIRECTOR, SENIOR BUDGET ANALYST, SUPERVISORY HEALTH SCIENTIST ADMINISTRATOR AND HEALTH SCIENTIST ADMINISTRATOR, AND ALL OF THESE RECRUITS ARE ACTIVELY BEING PURSUED, THE DEPUTY DIRECTOR POSITION IS OPENING OFFICIALLY I THINK APRIL 3, THE FIRST MEETING OF THE SEARCH COMMITTEE IS THIS WEEK. AND SIMILARLY WITH SENIOR BUDGET ANALYST IN OTHER POSITIONS WE'RE MOVING AHEAD VERY RAPIDLY TO IDENTIFY THE BEST CANDIDATES AND MOVE THESE SELECTIONS AND APPOINTMENTS ALONG AS QUICKLY AS WE CAN. AND SO CERTAINLY IF ANYONE KNOWS OF PEOPLE WHO WOULD BE CANDIDATES FOR THESE POSITIONS, PLEASE BE IN TOUCH AND HAVE THEM CHECK OUT THE WEBSITE WHEN THESE ARE OFFICIALLY LISTED. SO I WANT TO TAKE A FEW MINUTES TO TALK ABOUT THE UPDATE OF THE COUNCIL AND PASSING OF OUR DEAR COLLEAGUE AND FRIEND DR. BONNIE MATHESON WHO PASSED AWAY JANUARY 8, 2018, SNORKLING IN ARUBA, SOMETHING SHE LOVED TO DO. BONNIE ACTUALLY RETIRED IN DECEMBER 2017, AFTER A LONG AND DISTINGUISHED CAREER AT NIH, SPANNING 43 YEARS. SHE WAS HONORED IN NOVEMBER FOR HER SERVICE TO THE NIH BY THE NIH OFFICE OF THE DIRECTOR. MOST RECENTLY BONNIE SERVED AS HEALTH SCIENCE ADMINISTRATOR AT OAR WHERE SHE LED THE HIV/AIDS VACCINE PROGRAM, THAT IT THIS ROLE BONNIE LENT HER EXPERTISE, WISDOM, ADVICE AND SUPPORT TO NUMEROUS VACCINE TRIALS, INCLUDING RV144. SHE WAS A GREAT SPONSOR OF THE NATIONAL PRIMATE RESEARCH CENTERS AND SPF COLONIES, AND HELPED DEVELOP VACCINE SCHOLARS PROGRAM TO TRAIN THE NEXT GENERATION OF SCIENTISTS. PRIOR TO JOINING OAR, BONNIE WAS A PROGRAM OFFICER IN THE VACCINE BRANCH OF THE DIVISION OF AIDS, NIAID, WHERE HER IMMUNOLOGY EXPERTISE WAS VITAL TO NIH'S MISSION OF DEVELOPING AND TESTING AN HIV VACCINE. AND BEFORE JOINING NIAID BONNIE MADE SEMINAL CONTRIBUTIONS TO THE FIELD OF BASIC T CELL IMMUNOLOGY AS AN INVESTIGATOR HERE AT THE NIH IN THE NATIONAL CANCER INSTITUTE. BONNIE SERVED ON REVIEW BOARDS FOR WHO WORLD HEALTH ORGANIZATION AND GREATS FOUNDATION, AUTHORED CHAPTERS, WON ALUMNUS AWARD FROM THE WEILL CORNELL MEDICAL COLLEGE WHERE SHE RECEIVED HER Ph.D. IN MEDICAL SCIENCES, BACHELOR'S DEGREE IN BOUGHT BOTANY, AND MASTER'S DEGREE IN MEDICAL MICROBIOLOGY FROM LELAND STANFORD JR. UNIVERSITY. BONNIE POSSESSED A PASSION FOR BENCH SCIENCE, AND DEDICATED THE LATTER PART OF HER CAREER TO GUIDING HIV VACCINE RESEARCH, WELL RESPECTED MEMBER OF THE NIH COMMUNITY WHO SUPPORTED, ADVISED AND QUESTIONED COLLEAGUES IN EQUAL PART. BONNIE WAS A TIRELESS ADVOCATE FOR YOUNG PEOPLE, FOR WOMEN, AND EARLY CAREER INVESTIGATORS. SHE WAS RESPECTED AS INTERNATIONAL LEADER IN THE HIV VACCINE FIELD, AND DEVOUT SUPPORTER OF RESEARCH TO PREVENT HIV AND IMPROVE HEALTH AND OUTCOMES OF PEOPLE LIVING WITH HIV. THOSE OF US FORTUNATE TO KNOW AND WORK WITH BONNIE LOST A DEAR FRIEND, COLLEAGUE AND ALLY. WE AT OAR ALREADY MISS HER KNOWLEDGE, COMMITMENT, INSIGHT AND LAUGHTER. THE HIV/AIDS RESEARCH COMMITTEE LOST ANOTHER DEAR COLLEAGUE WITH THE PASSING OF DR. MATILDA KREM, A PIONEER FOR HIV/AIDS, PASSED AWAY JANUARY 15 OF 201, THE FOUNDING CHAIRMAN OF AMFAR, FAMILIAR FOUNDATION FOR AIDS RESEARCH, LEADER IN AIDS RESEARCH AND ACTIVISM, AT THE FOREFRONT OF SCIENTIFIC AND PHILANTHROPIC RESPONSE TO HIV/AIDS BEFORE THE WORLD UNDERSTOOD ITS GLOBAL CATASTROPHIC IMPACT, ACTIVE IN RESEARCH IN INTERFERON, IN AUGUST 2000 AWARDED PRESIDENTIAL MEDAL OF FREEDOM. AND FINALLY THE HIV/AIDS COMMUNITY MOURNS THE PASSING OF DR. DAVID COOPER ON MARCH 18. PROFESSOR COOPER WAS THE PAST PRESIDENT OF THE INTERNATIONAL AIDS SOCIETY, INTERNATIONALLY RECOGNIZED AS CLINICIAN AND INVESTIGATOR, SINCE DIAGNOSING SOME OF AUSTRALIA'S FIRST CASES OF HIV IN 1983, PROFESSOR COOPER DEDICATED HIS CAREER TO HIV EPIDEMIOLOGY, TREATMENT AND PREVENTION, THE AIDS RESEARCH COMMUNITY IS GRATEFUL FOR HIS TREMENDOUS CONTRIBUTIONS TO THE FIELD. I THINK WE'LL TAKE A COUPLE OF SECONDS OF SILENCE JUST TO THINK ABOUT OUR FRIENDS. OKAY. SO SINCE THE LAST -- THE NOVEMBER OARAC MEETING, I AM GOING TO UPDATE YOU BRIEFLY ON SOME OF THE ACTIVITIES THAT I'VE BEEN INVOLVED WITH IN STAKEHOLDER ENGAGEMENT. I WAS INVITED TO PRESENT AT THE INTERNATIONAL CONFERENCE ON EMERGING INFECTIOUS DISEASES IN THE PACIFIC RIM IN CHINA IN JANUARY, AND THEN HAVE BEEN ABLE TO DO OPENING REMARKS WHICH I REALLY LIKE TO DO AT A NUMBER OF THESE NIH WORKSHOPS AND MEETINGS OR SIM SYMPOSIUM, THREE IN THE LAST FEW MONTHS, ONE ON REGULATION OF CLINICAL RESEARCH RELATED TO HIV CURE, THE NIAID WORKSHOP ON HIV-1 NUCLEAR IMPORT AND NEUROHIV CONFERENCE THAT WAS JUST LAST WEEK, OR A COUPLE WEEKS AGO. OAR, MYSELF AND SOME OF -- SEVERAL OF THE HSAs ACCOMPANIED ME TO GO TO CROIX. MOST OF YOU WERE THERE SO WE'RE NOT GOING TO GO THROUGH VERY MUCH ABOUT THAT, EXCEPT WE DO WANT TO POINT OUT THAT DR. GINA BROWN DID A FACEBOOK LIVE INTERVIEW FOR HIV.GOV ON WOMEN-CENTERED RESEARCH FOR WOMEN, GIRLS, FOR WOMEN AND GIRLS FOR THE HIV/AIDS AWARENESS DAY MARCH 10 AND YOU CAN SEE THAT ONLINE IF YOU'RE INTERESTED. OAR HAS GEARED UP OUR COMMUNICATIONS, AND WHAT WE'RE NOW DOING IS WE'RE REDESIGNING THE WEBSITE THAT WILL LAUNCH IN EARLY SUMMER, AND WE HAVE A TWITTER ACCOUNT, SO YOU CAN TWEET OAR WITH MESSAGES. I'M JUST LOOKING BECAUSE I THINK I SOMEHOW GOT THE SLIDES MIXED UP. WORLD AIDS DAY WAS DECEMBER 1, 2017, AND WE HAD OAR SPONSORED AND HOSTED HIV AND BEYOND, THE BENEFITS OF HIV -- BENEFITS OF HIV RESEARCH, FOR WORLD AIDS DAY. WE HAD FIVE SPEAKERS FROM WITHIN THE NIH REPRESENTING DIFFERENT INSTITUTES AND CENTERS WHO TALKED ABOUT THE IMPACT OF HIV RESEARCH OVER THE YEARS, ON THE RESEARCH AGENDAS, AND ON THE RESEARCH AREAS IN THEIR INSTITUTES AND CENTERS. THAT IS FULLY RECORDED AND IS NOW ON THE OAR WEBSITE. ONE OF THE ACTIVITIES THAT OAR IS AUTHORIZED TO CARRY OUT IS TO PROVIDE A PROFESSIONAL JUDGMENT BUDGET, UNDER THE 1993 AUTHORIZATION, REPRESENTING OAR'S PROFESSIONAL JUDGMENT FOR ALLOCATION OF HIV RESEARCH FUNDS ACROSS NIH BASED SOLELY ON RESEARCH OPPORTUNITIES AND PRIORITIES, WITHOUT REGARD TO THE PROBABILITY THAT THE FUNDS WILL BE APPROPRIATED. WE SUBMITTED BUDGET DIRECTLY TO THE PRESIDENT AFTER OPPORTUNITY FOR COMMENT FROM THE SECRETARY OF HHS AND NIH DIRECTOR. IN 2018 THE OAR REQUESTED A 15% INCREASE OF $450 MILLION OVER FY 2017 ENACTED BUDGET, WHICH HAD A TOTAL REQUEST OF $3 BILLION. THE BUDGET DOCUMENT IS NOW POSTED FOR 2018, NOW POSTED ON THE WEBSITE, IT WAS PRESENTED, FORWARDED TO CONGRESS I BELIEVE AT THE END OF 2017. WE ARE CURRENTLY THE FY 2019 PROFESSIONAL JUDGMENT BUDGET IS IN REVIEW THROUGH THE NIH DIRECTOR AND SECRETARY OF HHS, AND WE EXPECT THAT TO BE POSTED IN THE NEXT COUPLE OF MONTHS. THE 2020 PROFESSIONAL JUDGMENT BUDGET, WE'RE IN THE PROCESS NOW OF INITIATING DEVELOPMENT OF THAT, IT WILL BE INFORMED BY THE FY 2020 STRATEGIC PLAN WHICH IS IN DEVELOPMENT, AND YOU'LL HEAR MORE ABOUT THE STRATEGIC PLAN PROCESS FROM DR. BROWN SHORTLY. TODAY ALSO ON OUR AGENDA WE'RE GOING TO BE HEARING ABOUT SOME WORK THAT OAR HAS BEEN UNDERTAKING TO EXAMINE AND DEVELOP SOME -- GATHER INFORMATION ABOUT IDEAS FOR HOW COST SHARING CAN BE IMPLEMENTED FOR HIV RESEARCH. THIS IS GOING TO BE -- THIS IS THE STRATEGIC PLAN FOR 2019-2020 THAT DR. BROWN IS GOING TO BE TALKING ABOUT. AND WE'LL ALSO BE HEARING PRESENTATIONS TODAY, UPDATES FROM THE NEW DIRECTOR OF THE NATIONAL CANCER INSTITUTE, WE'LL HAVE UPDATES FROM THE NATIONAL INSTITUTE OF MENTAL HEALTH, FROM THE CENTER FOR STRATEGIC RESEARCH, FOR REVIEW, AND FROM ONE OF OUR SISTER ORGANIZATIONS OR OFFICES WITHIN DPCPSI, THAT'S ORIP. WE'VE GOT A VERY FULL SCHEDULE. THANK YOU AGAIN FOR BEING HERE AND FOR WORKING WITH US ON THIS IMPORTANT ACTIVITY AND I WILL NOW TURN IT OVER TO ALICE PAU. >> SO THANK YOU. ALICE PAU, EXECUTIVE SECRETARY FOR ANTI-RETRO L GUIDELINES, CLINICAL STAFF SCIENTIST AT NIAID, PART OF THE INTRAMURAL CLINICAL MANAGEMENT AND OPERATIONS BRANCH, SHE'S GOING TO TALK ABOUT THE UPDATES FOR THE DHHS HIV/AIDS TREATMENT AND PREVENTION GUIDELINES. >> THANKS. I AGREE WITH MAUREEN ABOUT THE PODIUM. [LAUGHTER] THANKS FOR GIVING ME THE OPPORTUNITY HERE TO REPORT ABOUT THE ADULT ADOLESCENTS ANTIRETROVIRAL GUIDELINES, DR. MASUR AND HAZRA WILL REPORT ON THE OTHER GUIDELINES AS WELL. I'M REPRESENTING THE GUIDELINES PANEL, WHICH CONSISTS OF ABOUT 40 MEMBERS OR SO, AND SOME OF YOU MAY REMEMBER OUR FIRST GUIDELINES CAME OUT IN MMWR 20 YEARS IN 1998, APRIL 28, 1998, COMING UP ON THE 20th ANNIVERSARY VERY SOON. WE HAD 27 GUIDELINES UPDATES SINCE THEN, THE LAST WAS OCTOBER 17, 2017. SO WE'VE BEEN VERY BUSY OVER THE LAST 20-SOMETHING YEARS. FIRST I'M GOING TO REPORT SOME OF THE MEMBERSHIP CHANGES THAT'S GOING TO HAPPEN OR ACTUALLY HAD ALREADY HAPPENED. WE USUALLY HAVE REPRESENTATIVES FROM DIFFERENT DHHS AGENCIES, INCLUDING CDC, FDA, AS WELL AS HRSA AND NIH. WE HAVE TWO FDA REPRESENTATIVES, DR. ADAM SHERWOOD FROM FDA SERVED US FOR THREE OR FOUR YEARS, AND REPLACED BY DR. VIRGINIA SHAKE IN 2018. WE HAVE A NUMBER OF MEMBERS WHO WILL BECOME COMPLETING MEMBERSHIP AND TERMS IN APRIL OF 2018 WHEN WE'RE GOING TO HAVE A RETREAT ON APRIL 19, DR. MARTY HIRSCH WHO SERVED ON THE PANEL FOR THE NEXT 18 YEARS AND WAS ON THE PANEL IN 1996, 20 YEARS NOW, SERVED AS CO-CHAIR THE LAST FOUR YEARS, WILL BE LEAVING THE PANEL. THE PANEL WILL BE CO-CHAIRED BY DR. TRIP GULICK AND DR. CLIFF LANE. TWO SCIENTIFIC MEMBERS, DICK PRICE FROM UCSF AND TAMASKIN FROM MAYO CLINIC WILL BE LEAVING. JEFF TAYLOR WILL BE LEAVING PANEL AS WELL. THROUGH OPEN NOMINATION AND SELECTION PROCESS WE HAVE PICKED SEVEN MEMBERS BEGINNING THE TERMS IN APRIL 2018, NAMES LISTED DOWN THERE. THIS HAS BEEN A VERY BUSY YEAR ALREADY IN 2018, TWO DRUGS APPROVED, AS YOU HAVE SEEN, IN JANUARY OF 2018 TACK LA VEER WITH TWO OTHERS APPROVED, INTEGRASE BASED SINGLE TABLET REGIMEN IN TREATMENT NAIVE PATIENTS, APPROVED FOR TWO INDICATIONS, FIRST FOR TREATMENT NAIVE PATIENTS AS INITIAL THERAPY FOR ADULTS GREATER THAN 18 YEARS OF AGE, OR CASES AN INDIVIDUAL SUPPRESSED WITH NO RESISTANCE CAN BE SWITCHED TO THIS REGIMEN. IN MARCH OF 2018 IBALIZUMAB WAS APPROVED, FIRST LONG ACTING MONOCLONAL ANTIBODY THAT CAN BE GIVEN BY IV INFUSION EVERY TWO WEEKS, APPROVED FOR PATIENTS WITH MUST BE RESISTANT HIV INFECTION. WE'RE PROPOSING AND WE'LL BE UPDATING ONE-PAGE RECOMMENDATION COMING OUT TOMORROW, RECOMMENDING A LISTING AS ONE OF THE RECOMMENDED INITIAL REGIMENS FOR MOST PEOPLE WITH HIV. THE RECOMMENDATION WAS PRIMARILY BASED ON RESULTS FROM TWO LARGE PHASE 3 RANDOMIZED CONTROL TRIALS THAT DEMONSTRATED NON-INFERIORITY OF THIS REGIMEN WITH ONE OF THE RECOMMENDED REGIMENS IN THE GUIDELINES. IT SHOULD BE NOTED IT IS ONLY APPROVED FOR INDIVIDUALS 18 YEARS OR OLDER, A SMALL TRIAL WAS PUBLISHED, PRESENTED AT CROIX THIS YEAR FOR ADOLESCENCE BETWEEN 12 AND 18, LASTLY SHOULD BE NOTED THAT IT IS A SUBSTRATE OF CYP3A4 AND SUBSTRATES, NOT RECOMMENDED FOR USE WITH RIFAMYCISN, ANTI-CONVOLSUVANTS AND ST. JOHN'S WORT. A NUMBER OF TABLES THAT WE HAVE IN THE GUIDELINES INCLUDING DRUG INTERACTION, CHARACTERISTICS AND ADVERSE EVENTS WILL INCORPORATE INTO BIVTEGRAVIR. THE DISCUSSION WILL BE EXTENDED ON THE USE, CLINICAL USE OF PRO VIRAL DNA GEN TYPIC ASSAY IN THE GUIDELINES AS WELL, IN THE BIOLOGICAL FAILURE SECTION WE WILL BE USING -- INCLUDING APPROVAL OF IBALIZUMAB, AND LASTLY A NUMBER OF NEW STUDIES TO LOOK AT DIFFERENT WAYS IN WHICH WE CAN SWITCH A PATIENT FROM REGIMEN THAT THEY ARE RECEIVING AND UNDER GOOD SUPPRESION INTO NEW REGIMEN THAT COULD BE SIMPLER OR LESS TOXIC, SO THE REGIMEN SWITCHING SECTION WILL BE UPDATED IN ORDER FOR US TO INCORPORATE SOME OF THESE NEW DATA INTO THE GUIDELINES. TWO SECTIONS REQUIRE SOME UPDATING, NOT BEEN UPDATED FOR A FEW YEARS, INCLUDING SUBSTANCE USE AS WELL AS TB SECTION, AND THOSE WE ANTICIPATE TO BE UPDATED. THE WORK COULD NOT BE DONE WITH THE PEOPLE ON THE WORKING GROUP INCLUDING HHS REPRESENTATIVES, ACADEMICS AS WELL AS COMMUNITY MEMBERS. I ALSO WANT TO ACKNOWLEDGE THE WORK OF THE WEBSITE WHICH HELPS AND NUMBER OF OTHER WORK THAT NEEDS TO BE DONE, I'M GOING TO PASS TO DR. MASUR. >> HE SERVES AS CHIEF OF CRITICAL CARE MEDICINE DEPARTMENT AT NIH CLINICAL CENTER WHERE HE LEADS A GROUP OF PHYSICIANS WITH INTERNATIONAL ACCLAIM FOR TREATMENT OF INTERNATIONAL INFECTION. >> I'D LIKE TO GIVE AN OVERVIEW OF THE USE OF THESE GUIDELINES BEFORE WE TALK SPECIFICALLY ABOUT THE OPPORTUNISTIC INFECTION GUIDELINES. YOU ALL REALIZE THIS IS A SUBSTANTIAL INVESTMENT BY THE OFFICE OF AIDS RESEARCH. THE QUESTION IS HOW MUCH ARE THE GUIDELINES USED AND WHAT IMPACT DO THEY HAVE. THE LATTER IS DIFFICULT TO LOOK AT, THE FORMER IS EASIER TO GET SOME METRICS ON. IF YOU LOOK AT THE NUMBER OF PAGE VIEWS, YOU LOOK ON THE LEFT SIDE HERE, FROM ANTIRETROVIRAL GUIDELINES, O I, PERINATAL, PEDIATRIC, YOU CAN SEE SUBSTANTIAL NUMBER OF PAGE VIEWS SUGGESTING GUIDELINES ARE USED BY THE PRACTICING COMMUNITY. IF YOU LOOK AT THE TRENDS, YOU CAN SEE OVER TIME THESE GUIDELINES ARE USED MORE AND MORE. WHY THIS IS, I THINK REQUIRES MORE ANALYSIS BUT USE BY PROVIDERS OF EACH OF THE GUIDELINES IS NOT GOING AWAY, SUGGESTING THESE ARE STILL VALUED BY THE COMMUNITY THAT WE'RE TRYING TO SERVE. IF YOU LOOK AT HOW THE USE OF GUIDELINES IS CHANGING, THERE'S A TIME WHEN THEY WERE PUBLISHED IN PRINT FORM, NOW OBVIOUSLY THEY ARE ALL ONLINE, IF YOU LOOK ON THE LEFT SIDE, WITH DIFFERENT Y-AXIS, THE GUIDELINES ARE DOWNLOADED AS PDFs WITH HIGH FREQUENCY. WHY THERE ARE THESE PEAKS AND VALLEYS, I THINK IS ANOTHER ISSUE. WHEN A NEW VERSION OF A GUIDELINE COMES OUT, ESPECIALLY WITH IMPORTANT CHANGES, THERE'S OFTEN A BUMP IN ACTIVITY. BUT YOU CAN SEE, AGAIN, THAT THE GUIDELINES WITH THE HELP OF ALI McDOUGAL AND HER TEAM CAME UP WITH NEW WAYS OUR AUDIENCE TRIES TO USE THESE. WE'LL PROBABLY SEE THE APP DOWNLOADS USED MORE AND MORE. IF YOU'RE INTERESTED IN THE METRICS OF HOW PEOPLE FIND THESE GUIDELINES, THERE ARE A VARIETY OF SEARCH TERMS THAT PEOPLE USE. YOU CAN SEE MOST PEOPLE GO TO GOOGLE, YAHOO, SOMETHING LIKE THAT, LOOKING SPECIFICALLY FOR GUIDELINES. SOME PEOPLE ARE REFERRED FROM OTHER WEBSITES LIKE UP TO DATE, YOU CAN SEE THAT THERE ARE REFERRALS FROM THE PLACES YOU WOULD EXPECT THEM, FACEBOOK, TWITTER, ET CETERA. SO, AGAIN, I THINK AIDS INFO IS TRYING TO UNDERSTAND HOW PEOPLE ACCESS AND WHO IS ACCESSING SO WE CONTINUE TO MAKE SURE THAT PEOPLE CAN FIND THESE BY THE MEDIA THEY LIKE TO USE. LET'S TURN TO THE GUIDELINES, THERE'S SOME PEOPLE WHO DID THE SEMINAL STUDIES WE REFERRED TO 30 YEARS LATER. BILL POWERLY, CRYPTOCOCCAL, DICK CHASE ON TB, THE STAPLES BECAUSE IN SOME WAYS THESE GUIDELINES ARE BASED ON STUDIES DONE 25 YEARS AGO, OUR CHALLENGE AS OPPOSED TO ANTIRETROVIRAL KEEPING THESE CURRENT WITH NOT MANY TRIALS, LOOKING AT OBSERVATIONAL STUDIES AND USING PLAUSIBLE INFERENCES FROM OTHER PATIENT POPULATIONS. O I GUIDELINES ARE UPDATED MULTIPLE TIMES. GUIDELINES STARTED IN 1989 WITH THE ONLY THING WE KNEW HOW TO DO, TO PREVENT PNEUMOCYST IS PNEUMONIA, MORPHING INTO PREVENTION AND TREATMENT OF OPPORTUNISTIC INFECTION IN GENERAL, AND NIH WAS JOINED BY CDC AND IDSA, OAR PROVIDES ALL THE FUNDING FOR THESE GUIDELINES, AND CURRENTLY JOHN BROOKS FROM CDC IS AN IMPORTANT MEMBER AND MAKES SURE GUIDELINES ARE HARMONIZED WITH CDC, AN IMPORTANT ISSUE, FEDERAL GUIDELINES MAY NOT BE IDENTICAL BUT ARE HARMONIZED, DIFFERENCES FROM ONE DOCUMENT TO ANOTHER. KING HOLMES REPRESENTED IDSA FROM THE BEGINNING, CONNIE BENSON ISED A AN AD HOC LEADER AS WELL. IF YOU LOOK AT THE PARTS USED, PEOPLE LOOK AT WHAT'S NEW, ALSO THE STAPLES OF PNEUMOCYST, AND MICRO BACTERIUM PEOPLE COMMONLY USE. WE DO GUIDELINES DIFFERENT FROM ANTIRETROVIRAL. WE HAVE A CALL EVERY MONTH WITH LEADERSHIP, EVERY QUARTER SUBJECT GROUP LEADS ON OPPORTUNISTIC PAST GENERALS HAVE A CALL. WE ASK EACH SUBJECT GROUP LEADER IF THEY REVIEWED THEIR SECTION, WHETHER THERE ARE UPDATES NEEDED AND MAKE A DECISION ABOUT MOVING FORWARD WITH AN UPDATE AND DECIDE BASED ON THE IMPORTANCE OF THE NEW INFORMATION WHAT THE URGENCY OF THAT UPDATE IS. WE DO THESE UPDATES IN REAL TIME SO AS SOON AS THE SUBJECT GROUPS HAVE THEIR UPDATE READY, IT IS POSTED, AND AIDS INFO HAS BEEN GREAT ABOUT DOING THAT ON AN AS-NEEDED BASIS. WE RELY ON VOLUNTEERS AS DO ALL OF THE GUIDELINES, AND WE'RE PLEASED WE HAVE PEOPLE WILLING TO VOLUNTEER, WE TRY TO MAKE SURE THERE'S TURNOVER OF MEMBERSHIP, EACH PERSON THAT IS A 3-YEAR TERM, RENEWAL OPTION. WE WELCOME ANY OF YOU WHO HAVE SUGGESTIONS ABOUT NEW MEMBERS. WE'RE LOOKING FOR DIVERSITY OF ALL SORTS. AND WE'RE LOOKING FOR YOUNGER PEOPLE WHO HAVE EXPERIENCE WITH OPPORTUNITY IN INFECTIOUS DISEASE AND WANT TO MAKE CONTRIBUTIONS SO WE ADVERTISE FOR NEW MEMBERS AND WE WELCOME SUGGESTIONS. IF YOU LOOK AT THE SPECIFIC UPDATES, THERE ARE UPDATES THAT ARE IMPORTANT TO MAKE SURE PROVIDERS ARE AWARE OF. FOR INSTANCE RECOGNIZING THAT FOR HPV NON-VALENT VACCINE IS WHAT IS RECOMMENDED, WAS A CHANGE WE MADE RECENTLY. WITH HHV8 INFORMATION ABOUT NEW SYNDROMES LIKE KICKS, MANAGING MULTI-CENTRIC CASTLEMANS, DETAILS UP TO DATE FOR INSTANCE WITH CAN DETECTIVE A, ISOVUKONAZOL IS NOT A MAJOR CHANGE, DRUGS INCLUDED IN THE GUIDELINES, DETAILS ABOUT PHARMACOKINETICS. ALI McDOUGAL IS IMPORTANT, NOT WOULD EXIST WITHOUT ALICE PAU, ACCURACY DEPENDS ON ALICE IS DOING THAT, MAKING SURE TABLES GET UPDATED, AND INFORMATION IS HARMONIZED WITH WHAT IS IN THE TEXT. THERE ARE SOME NEW CHANGES WHICH I THINK WILL HAVE IMPACT. WE'VE DEBATED FOR A COUPLE YEARS ABOUT WHETHER IN THIS ERA MICROBACTERIUM PROPHYLAXIS SHOULD BE INDICATED AND WE'VE DECIDED BASED LARGELY ON OBSERVATIONAL DATA TO WITHDRAW THAT FOR PRIMARY PROPHYLAXIS, THAT'S COMING SOON. THERE'S A LOT OF DEBATE WHICH OF THE ZOSTER VACCINES TO BE USED, IN THE ABSENCE OF DATA, WE'RE WAITING FOR CHRISTINE JOHNSON AND PANEL TO SUGGESTION OUR PERSPECTIVE AND JOHN BROOKS IS WORKING WITH CDC TO MAKE SURE SAY. HEPATITIS C IS AN INTERESTING ISSUE, CHANGES SO QUICKLY. WE HAVE ELECTED NOT TO FOCUS SO MUCH ON THE THERAPY OF HEPATITIS C, TO RELY ON THE GUIDELINES WHICH ARE UPDATED IN REAL TIME, THE MOST UPDATED INFORMATION ON TREATMENT, SO WE LARGELY REFER TO THEM. THERE ARE NEW CHANGES COMING OUT ABOUT HOW TO MANAGE HPV, AND THERE WAS INTERESTING NEW DATA, SOME OF WHICH WAS REPORTED BY DR. CHAISEON AT CROIX, ONE THING WE STRUGGLED WITH WITH NEW INFORMATION IS WHEN THERE'S NEW INFORMATION PRESENTED, ABSTRACT, SHOULD THAT GO INTO THE GUIDELINE BEFORE IT APPEARS IN PRINT? SO WE DON'T WANT TO BE -- WE DON'T WANT LACK OF CURRENCY. WE WANT TO BE UP THE TO DATE. SO THE TB SUBGROUP IS NOW DECIDING WHAT EXACTLY WE WILL SAY AND WHEN WE WILL SAY THAT. THAT'S BASICALLY WHERE WE STAND WITH THE OI GUIDELINES, NOW ROHAN IS GOING TO TELL YOU ABOUT THE PEDIATRIC GUIDELINES. >> DR. ROHAN, EXECUTIVE SECRETARY OF HHS PANEL ON ANTIRETROVIRAL, PEDIATRIC, NATIONAL INSTITUTE OF CHILD AND HUMAN DEVELOPMENT. >> THANK YOU. I'M GOING TO GO OVER THE THREE PEDIATRIC AND MATERNAL GUIDELINES, THE PEDIATRIC TREATMENT GUIDELINES, THE PERINATAL GUIDELINES AND PEDIATRIC OI GUIDELINES. FIRST WITH PEDIATRIC GUIDELINES, THIS IS THE TIME OF YEAR WE DO A FULL UPDATE OF THE GUIDELINES, SO WE'RE RAPIDLY GETTING READY TO DO THAT, HOPEFULLY FINISH UP AND PUBLISH NEXT MONTH. I'M GOING TO GIVE YOU THE UPDATE SINCE WE LAST MET. WE HAVE THREE SECTIONS PUBLISHED IN NOVEMBER THAT WE'VE NOW DEVELOPED JOINTLY WITH THE PERINATAL PANEL AND THEY ARE LISTED THERE, RELATED TO MATERNAL HIV TESTING AND IDENTIFICATION OF PERINATAL EXPOSURE IN THE BABY, ART MANAGEMENT OF NEWBORNS WITH EXPOSURE AND DIAGNOSIS OF INFECTION IN INFANTS AND CHILDREN. I THINK THIS SPEAKS TO SOME OF WHAT HENRY AND ALICE HAVE BEEN SAYING TRYING TO STANDARDIZE ACROSS GUIDELINES WHEN THERE ARE COMMON ISSUES BEING DEALT WITH. AGAIN, DON'T NEED TO REMIND YOU ALL OF THESE PANELS ARE WORKING GROUPS OF THIS COUNCIL, AND THEREFORE MAKES OF COURSE TOTAL SENSE THAT THEN THEY SHOULD BE CONSISTENT WHEN THEY ARE DEALING WITH THE SAME OR SIMILAR ISSUES. WITH THIS UPDATE THAT'S COMING UP WITH THE PEDIATRIC GUIDELINES BY NEXT MONTH, REALLY HAVE DONE A COMPLETE REVIEW OF ALL OF THE SECTIONS, AND WE ALSO AS PART OF OUR ANNUAL PROCESS HAVE LOOKED AT MEMBERSHIP AND HAVE IN THE PROCESS OF INVITING NEW MEMBERS WHOM I WILL BE ABLE TO TELL YOU ABOUT THE NEXT TIME WE MEET. AND AS I MENTIONED, WE'RE WORKING TOWARDS PUBLISHING WHOLE NEW VERSION NEXT MONTH. I WANTS TO START WITH THE PEDIATRIC GUIDELINES TALKING ABOUT ANNIVERSARIES THAT WE HAVE. SO THERE WAS ACTUALLY 25 YEARS AGO, 1993, AN NIH-LED NATIONAL GUIDELINE FOR PEDIATRIC HIV AND SO THIS WAS A PEDIATRIC HIV RESOURCE CENTER GUIDELINE ON ANTIRETROVIRAL THERAPY, LED BY PHIL PIZZO AND KATHY WILLFORD, WE'VE BEEN PROVIDING GUIDELINES FOR 25 YEARS ON THE CARE AND MANAGEMENT OF THE HIV-INFECTED CHILD. YOU CAN IMAGINE INTERESTING READING IF YOU WERE TO GO BACK AND LOOK AT THIS DOCUMENT, WHEN BASICALLY ALL WE HAD WAS AZT AND JUST A LITTLE BIT OF 3TC TO WHERE WE ARE NOW AS I'LL TALK ABOUT IN A COUPLE SLIDES. SIMILAR TO ADULT GUIDELINES IN 1998, SO 20 YEARS AGO, ALSO WITH THE MMWR WAS A FEDERAL GUIDELINE FOR THE USE OF ART, IN PEDIATRIC INFECTION SO CHAIRED BY DR. ZOLETSKI FROM SCOTT FROM NEW JERSEY AND UNIVERSITY OF MIAMI, CELEBRATING THIS YEAR WITH THIS PUBLICATION. SIMILAR TO THE OTHER SLIDE LOOKING AT THE MOST ACCESS PAGES IN THE LAST YEAR FROM THE PEDIATRIC GUIDELINES. SO THE MOST COMMON IS ACTUALLY DIAGNOSIS, FOLLOWED BY WHAT'S NEW, NEVIROPENE RECOMMENDATION FOR THERAPY IN CHILDREN AND ZIVOVUDINE, SPEAKING TO HOW MUCH PERINATAL EXPOSURE IS VERY MUCH AN ISSUE WITH RESPECT TO HOW TO DIAGNOSE HIV, ESPECIALLY GIVEN THE NEWER ASSAYS AND COMPLICATED ISSUES RELATED TO ANTIRETROVIRAL THERAPY AND IMPACT ON VIRAL LOAD IN BABIES BUT THEN ALSO USE STILL OF ZDV AND NEVIROPENE AS FIRST LINE FOR PREVENTION. AS I MENTIONED, WITH THE UPDATE THAT'S COMING NEXT MONTH ALL OF THE SECTIONS HAVE BEEN REVIEWED AND UPDATED TO INCLUDE NEW DATA AND PUBLICATIONS WHEN INDICATED. AND I'M JUST GOING TO GO THROUGH SOME OF THE HIGH LEVEL CHANGES THAT WE'RE PROPOSING. WE'VE ALWAYS TALKED ABOUT HAVING VIRAL LOAD MEASUREMENT EVERY THREE ON FOUR MONTHS AS A WAY TO CONTINUE TO ASSESS ADHERENCE AS CHILDREN GROW AND DEVELOP AND CHANGE BOWS AND FORMULATION. FOR NOW IT'S LISTED AS A BULLETED RECOMMENDATION WITH AN A3 RATING, STRONGLY ENCOURAGED BUT BASED ON EXPERT OPINION. WE NOW STRONGLY RECOMMEND ALL CHILDREN SHOULD RECEIVE ART, THERE'S VERY LIMITED DATA IN CHILDREN TO SAY THAT THEY SHOULD ALL BE TREATED. BUT REALLY WITH THE PREPONDERANCE OF EVIDENCE WE SEE IN ADULTS AND ADOLESCENTS, PLUS FRANKLY EASIER EASE OF THERAPY AND LESS TOXIC THERAPIES DEVELOPED THE PANEL HAS GONE TO THIS IS NOW A STRONG RECOMMENDATION FOR ALL CHILDREN. WHAT TO START SECTION GETS A LOT OF UPDATES, BECAUSE OF THE NEW DRUGS THAT ARE AVAILABLE, BUT ALSO COMPLICATION OF WHEN DO WE DECIDE THERE'S ENOUGH PEDIATRIC DATA TO THEN ENDORSE AGENTS IN THIS WHEN TO START SECTION. HEATED DEBATES, GIVEN, AGAIN, THAT OFTENTIMES ALL WE HAVE HAD RELATIVELY SMALL PHASE 1 STUDIES OF SAFETY AND PHARMACOKINETICS AND TRYING TO DECIDE WHEN DO WE THEN ENDORSE THE USE OF PARTICULAR AGENTS AS FIRST LINE THERAPY IN CHILDREN. SO ONE OF THE THINGS WE HAVE DONE IS EXPANDED SORT OF THE DIFFERENT ISSUES THAT NEED TO BE ADDRESSED, WHEN SELECTING AN ANTIRETROVIRAL REGIMEN INCLUDING CAN THE CHILD SWALLOW A PILL VERSUS LIQUID, HOW MANY PILLS CAN THEY TAKE, SOMETHING AS SIMPLE AS RETONVIRE REQUIRES TWO STRENGTHS TO FORM THE APPROPRIATE DOSE FOR A CHILD, A NO-BRAINER FIRST LINE IN ADOLESCENT OR ADULT FOR A CHILD NOT PRACTICAL BECAUSE MUCH OF TWO FORMULATIONS YOU HAVE TO PROVIDE TO GIVE THE DOSE YOU WANT, THERE'S A LOT OF ISSUES, WE'VE EXPANDED TO SAY THIS IS EXTREMELY COMPLICATED DISCUSSION THAT NEEDS TO INVOLVE FAMILY, CAREGIVER, YOU KNOW, SCHOOL, WHO IS GOING TO BE ADMINISTRATION MEDICATION, AND THEN WHAT THE CHILD CAN TAKE AND TOLERATE. WE'VE EXPANDED THAT. RALOTEGROVIR IS NOW APPROVED DOWN TO BIRTH, A MAJOR ADVANCE, BASED ON RELATIVELY SMALL STUDY OF SAFETY AND PHARMACOKINETICS IN HIV UNINFECTED BUT EXPOSED CHILDREN. REALLY WE HAVE PRACTICALLY NO DATA ON THE USE OF RALOTEGROVIR IN HIV-INFECTED NEONATES. IN ADDITION IT'S QUITE A COMPLICATED FORMULATION TO ADMINISTER. SO IT WAS A FAIR AMOUNT AGAIN, A LOT OF DEBATE WHETHER WE SHOULD LIST AS PREFERRED OR NOT BUT WHEN YOU RECOGNIZE THAT AT THIS POINT FOR A NEONATE, OR ANY BABY WITHIN THE FIRST TWO WEEKS OF LIFE, THE ONLY ALTERNATIVE, THE ONLY OPTION FOR FIRST LINE THERAPY IS NEVIROPENE, SUBOPTIMAL, THE PANEL WEIGHED IN AND DECIDED TO ENDORSE RALOTEGROVIR AS PREFERRED OPTION BUT AGAIN WITH THAT STRONG WARNING THERE'S ALMOST NO DATA ON ITS USE IN INFECTED INFANTS, AND IT IS A COMPLICATED REGIMEN TO ADMINISTER. THE FDC TABLETS, GENVOYA IS NOW RECOMMENDING. IT'S JUST EASY AND COMFORT WITH USE OF THESE AGENTS, SO INITIALLY WILL BE RECOMMENDED AS USED IN SPECIAL CIRCUMSTANCES WHEN THERE'S JUST SAFETY AND PK DATA AND THEN AS THERE'S MORE USE OF THE AGENT IN CLINICAL PRACTICE IT MOVES UP AND AT THIS POINT FOR THIS ONE GENVOYA IS LISTED AS OPTION. TAF/FTC COMBINATION PREFERRED, BACKBONE OFFICE, LESS THAN OR EQUAL TO 6 YEARS OF AGE BECAUSE OF AVAILABILITY OF A SAFETY AND PK DATA IN THAT AGE GROUP. TENOFOVIR IS AN ALTERNATIVE BACKBONE TO CHILDREN LESS THAN 12 YEARS OF AGE, PREVIOUSLY IN SPECIAL CIRCUMSTANCES, ALL OF YOU PROBABLY KNOW WHILE IT WAS WIDELY ENDORSED FOR USE IN ADOLESCENTS IN ADULTS, BECAUSE OF ITS BONE TOXICITY AND POTENTIALLY INCREASED EFFECT ON THE BONE OF GROWING AND DEVELOPING CHILDREN THERE WAS A RELUCTANCE TO USE TENOFOVIR IN YOUNGER CHILDREN, EVEN THOUGH THERE WAS FDA APPROVAL DOWN TO 2 YEARS OF AGE. AGAIN, I THINK SOME OF THIS EVOLUTION OF NOW HAVING IT LISTED AS ALTERNATIVE IS PARTLY BECAUSE WE'RE SEEING MORE AND MORE DATA TO SHOW ONCE A CHILD COMES OFF TENOFOVIR BONE DENSITY DOES SEEM TO RECOVER THOUGH IT DOES TAKE TIME BUT FRANKLY THERE ARE SO MANY OTHER OPTIONS. NOW PEOPLE ARE POTENTIALLY COMFORTABLE USING TDF, NOT TENOFOVIR, TDF FROM 2 TO PUBERTY AND SWITCH TO TAF, AVAILABILITY ALLOWSES FOR CHANGES BUT WITH THE ABSENCE OF DATA HOW WE SHOULD BE USING THEM. BECAUSE NOW THE AVAILABILITY OF TAF DOWN TO 6 YEARS OF AGE, BECAUSE PEOPLE ARE MORE COMFORTABLE USING TDF, ZDV WHICH HAS BEEN THE CORNERSTONE OF TREATMENT AND PREVENTION IN INFANTS AND CHILDREN, IS NOW DOWNGRADED TO AN ALTERNATIVE NRTI. AGAIN SHOWS YOU THE LAG IN PEDIATRIC TREATMENT BECAUSE OBVIOUSLY ZDV IN THE ADULT WORLD HAS NOT BEEN A PREFERRED ALTERNATIVE FOR MANY, MANY YEARS. ZDV NOW FOR CHILDREN AND ADOLESCENTS GREATER THAN 6 NOW AN ALTERNATIVE GIVEN WE NOW HAVE THE AVAILABILITY OF TAF-CONTAINING FORMULATIONS. THAT WAS JUST A QUICK SUMMARY OF CHANGES IN WHAT TO START. WE ALSO HAVE A MAJOR SET OF SECTIONS ABOUT MANAGING CHILDREN WHO ARE ON ANTIRETROVIRAL THERAPY. AS YOU CAN MESSAGE A LOT OF THE ISSUES THAT I TALKED ABOUT WITH RESPECT TO THE USE OF AGENTS AS FIRST LINE THERAPY ALSO IMPACTS HOW THEY SHOULD BE USED IN CHILDREN ON THERAPY, WHEN DO YOU SWITCH, HOW DO YOU SWITCH, WHO TO USE FOR SECOND LINE, THIRD LINE, ET CETERA. MANY OF THE CHANGES THAT I TALKED ABOUT FOR WHAT TO START ENDED UP BEING MADE IN THESE SECTIONS ON MEDICAL MANAGEMENT OF CHILDREN ON ANTIRETROVIRAL THERAPY. ALSO THE SECOND BULLET HERE ABOUT ISSUES RELATED TO CHILDREN FROM LIMITED RESOURCE SETTINGS, AND CHILDREN TRAVELING BACK AND FORTH TO THEIR HOME COUNTRIES, IS ACTUALLY AN INTERESTING ONE BECAUSE THESE ARE U.S. GUIDELINES. BUT WHAT WE'RE ALSO NOW REALIZING THANKS TO DATA FROM CDC THERE ARE MORE CHILDREN NOW DIAGNOSED WITH HIV IN THE UNITED STATES FOREIGN BORN THAN WHO ARE BORN IN THE UNITED STATES. SO THE GROUP THAT'S ACTUALLY MOST -- SEEING MOST IN TERMS OF BEING STARTED ON TREATMENT OR NEEDING TO HAVE THEIR TREATMENT MANAGED ARE CHILDREN COMING FROM OTHER COUNTRIES. AND SO AGAIN BECAUSE OF INPUT FROM THE PRACTITIONERS ON THE GUIDELINES AND AVAILABILITY OF DATA FROM CDC WE'RE TRYING TO EXPAND MANAGEMENT OF THAT SITUATION, NOT BY HAVING A SPECIAL SECTION BUT REALLY TRYING TO BE COGNIZANT OF THOSE ISSUES THROUGHOUT THE WHOLE GUIDELINE. WE HAVE PROBABLY SOME OF YOU KNOW, MANY CHILDREN ARE OFTEN NOT AT THE MAJOR URBAN CENTERS WHERE THERE'S A LOT OF PEDIATRIC TREATMENT SO WE HAVE FOLKS FROM DENVER, SEATTLE, THE MIDWEST ACTUALLY HELPING TO MANAGE HOW DO WE MAKE SURE WE'RE DEALING WITH THOSE ISSUES OF THE ADOPTED OR IMMIGRANT CHILD THROUGHOUT THE GUIDELINES. WE HAD A SECTION ON THE ROLE OF THERAPEUTIC DRUG MONITORING, THAT IS REALLY AT THIS POINT NOW WITH FIXED DOSE COMBINATIONS AND REALLY PRETTY GOOD SAFETY AND PK DATA, THERE'S LESS AND LESS USE OF TDM, AND SO WE'VE GONE AHEAD AND WE'RE GOING TO GO AHEAD AND REMOVE THAT SECTION, BUT THE OLD SECTION WILL BE AVAILABLE IN THE ARCHIVED GUIDELINES. AND THEN WHAT I'VE LISTED HERE IS JUST INDIVIDUAL DRUG SECTIONS THAT HAVE HAD MAJOR UPDATES. MOST I'VE TALKED ABOUT WHEN I TALKED ABOUT WHAT TO START BUT I WANTED TO TOUCH ON A COUPLE OF THEM. 3TC PEOPLE ARE SAYING WHAT WOULD YOU CHANGE IN 3TC, WE'VE HAD THE TROUBLE AVAILABLE SINCE 25 YEARS AGO. WE'LL SHOW HOW SLOW IT IS TO GET THE RIGHT DOSE IN PEDIATRICS. SORBITOL NEGATIVELY AFFECTS. FDA APPROVED A HIGHER DOSE OF 3TC THAN WHAT WE USED FOR 20 OR 25 YEARS, THAT'S THE CHANGE. I'LL TOUCH ON THERE THAT RALOTEGROVIR THERE'S AN ORAL POWDER FORMULATION. ALEX MENTIONED THE BIG TEGROVIR, WE'LL BE LOOKING AT DATA TO DECIDE IF AND WHEN WE SHOULD BE ENDORSING THE TEGROVIR-CONTAINING COMBINATION FOR ADOLESCENTS. I TALKED ABOUT THE MAJOR CHANGES FOR RALOTEGROVIR IN RELATION TO NEONATAL TREATMENT. WE HAVE IN-PROCESS CHANGE. IN ADDITION TO I MENTIONED FOR RALOTEGROVIR WE'VE ENDORSED FOR TREATMENT BUT THERE'S THE ISSUE OF WHAT WE CALLED PREEMPTIVE THERAPY, A BABY BORN IN A HIGH RISK SITUATION, WHERE PRACTITIONERS WANT TO GO AHEAD AND START WITH TRIPLE ANTIRETROVIRALS WHILE WAITING FOR TESTING. WE'LL PROPOSE CHANGES ON USE OF RALOTEGROVIR IN THAT SETTING AND, AGAIN, THAT WAS THE TRIAL THAT ACTUALLY DEVELOPED THE DATA FOR ITS USE, WAS IN THAT PARTICULAR SETTING. SO ACTUALLY THERE WE'LL HAVE THE DATA FOR WHAT WE'RE ACTUALLY TRYING TO DO. AND SO WE'LL BE WORKING ON SOME OF THOSE UPDATES WITH THE PERINATAL PANEL, ONCE BOTH PANELS APPROVE THE CHANGES, THEN WE'LL HOPE TO MAKE THOSE AS A REALTIME UPDATE. AND THEN AS I MENTIONED WE'RE GOING TO BE LOOKING AT THE ADOLESCENT DATA FOR BIGGING AT THE ROW VEER DISCUSSED AS CROIX AND THEN SOME OF YOU MAY KNOW THERE'S A LOW DOSE FIXED DOSE COMBINATION WITH RESPECT TO PEDIATRIC USE, THOSE DISCUSSIONS COMING AFTER WE PUBLISH THE NEXT FULL VERSION AND HOPE TO MAKE THOSE THOSE AS REALTIME UPDATES AS WELL. I'M SWITCHING TO THE PERINATAL GUIDELINES, A NEW EXECUTIVE SECRETARY FROM THE PERINATAL GUIDELINES, GEORGE STEPPED DOWN AS EXECUTIVE SECRETARY, AND NAHITA IS NOW THE NEW EXECUTIVE SECRETARY. THIS GUIDELINE AIMS TO PUBLISH ONE FULL UPDATE EVERY YEAR AND PERIODIC PARTIAL UPDATES AS NEW INFORMATION BECOMES AVAILABLE. THE FULL UPDATE FOR THIS PANEL WAS PUBLISHED LAST FALL. AS I MENTIONED THAT INCLUDED THREE SECTIONS WITH THE PEDIATRIC PANEL, THE PLAN TO HAVE A FULL UPDATE MORE AT THE END OF THIS CALENDAR YEAR. THERE'S THE SAME USAGE GRAPH FOR THE PERINATAL GUIDELINES, JUST TO SHOW YOU THERE THAT THE MOST COMMON PAGE IS WHAT'S NEW, FOLLOWED BY INFANT PROPHYLAXIS, MANAGEMENT OF NEWBORNS, POSTNATAL, AND INTRAPARTUM PROPHYLAXIS, THESE ARE THE MAJOR SECTIONS FOR THAT GUIDELINE, THE MEAT OF WHAT THIS GUIDELINE ADDRESSES, HOW TO MANAGE THE HIV-INFECTED AND EXPOSED INFANT. AS I MENTIONED THE FULL UPDATE WAS LAST NOVEMBER. A NEW SECTION WILL BE PUBLISHED SOON ON BREASTFEEDING THAT WE DID TALK ABOUT AT THE OARAC MEETING LAST FALL. THERE WILL BE SOME PERIODIC UPDATES, AS I MENTIONED, WITH SOME OF THE NEWER AGENTS, AS THERE ARE DATA THAT BECOME AVAILABLE IN PREGNANT WOMEN, BUT THEN WITH FULL REVISION PLANNED IN THE FALL OF 2018. MOVING TO THE PEDIATRIC OI GUIDELINES, TWO, GEORGE SYBERRY STEPPED DOWN, REPLACED BY BILL KAPAJONAS, A SPECIALIST IN MY BRANCH AT NICHD, SIMILAR TO ADULT GUIDELINES DEVELOPED IN COLLABORATION WITH A NUMBER OF GROUPS INCLUDING CDC, HIV M.A., IDSA, PEDIATRIC INFECTIOUS DISEASE SOCIETY AND AMERICAN ACADEMY OF PEDIATRICS, EACH TOPIC IS REVIEWED, UPDATED AND PUBLISHED INDIVIDUALLY. THERE'S A LIST OF MOST ACCESSED PAGES IN THE LAST YEAR AND THE MOST COMMON ONE IS IMMUNIZATION SCHEDULE IN HIV-INFECTED CHILDREN FOLLOWED BY TABLE OF SIGNIFICANT DRUG-DRUG INTERACTIONS, WHAT'S NEW, PCP AND HHV 8. THESE UPDATES ARE FINISHING GOING THROUGH CDC CLEARANCE AND SO I'M GOING TO TOUCH ON THE SUMMARY OF SOME OF THESE, IN CANADA JUST AS HENRY MENTIONED REALLY ADDING THE NEWER AGENTS AND RECOMMENDATIONS FOR THOSE AGENTS, STRENGTHENING RECOMMENDATION FOR NIDOXADI FOR TREATMENT, UPDATING TESTING PROPHYLAXIS AND THERAPY FOR CMV AND EXPANDING SECTION ON HCV, UPDATED TESTING AND EVALUATION RECOMMENDATIONS AND USE OF THE DAAs IN CHILDREN. ADDING RECOMMENDATION FOR DISCONTINUING SECONDARY PROPHYLAXIS, MACK, WE'RE STILL ENDORSING USE OF MACK PROPHYLAXIS WHEN INDICATED, BUT LOOKING AT WHEN TO START A.R.T., PATIENTS TREATED FOR DISSEMINATED MACK, LOOKING AT TB SECTION AND UPDATING THAT BASED UPON MORE RECENT INFORMATION, AND ALSO UPDATING THE VARICELLA ZOSTER SECTION. ACROSS FIVE PANELS IT'S 200 VOLUNTEERS THAT PROVIDE A LOT OF TIME AND EXPERTISE AND THOUGHTFUL CARE TO ALL THESE DIFFERENT ISSUES, SO I WANT TO THANK ALL OF THOSE VOLUNTEERS ON THOSE PANELS TO THANK ALI McDOUGAL AND HER GROUP AT AIDS INFO, THANK YOU FOR YOUR ATTENTION, AND HAPPY TO TAKE ANY QUESTIONS. >> OKAY. WE'LL OPEN UP THE WHOLE THING FOR DISCUSSION. THE ADULT GUIDELINES, OI GUIDELINES AND PEDIATRIC AND PERINATAL. ANY COMMENTS FROM THE COUNCIL? AND EVENTUALLY WE'LL ACTUALLY VOTE ON THESE, SO KEEP THAT IN MIND WHEN YOU DISCUSS. I HAD A QUESTION -- I'M SO SORRY. WAS THERE A QUESTION OVER HERE? LINDA, PLEASE, YES. GO AHEAD. >> DR. MASUR, I WAS WONDERING ABOUT THE RATIONALE FOR THE MICROBACTERIUM, NO TAKERS, IS THAT THE DEAL? SUCCESS? >> SO I MEAN THAT'S BEEN A CONTROVERSIAL ISSUE BECAUSE WE CAN'T DO A CONTROLLED TRIAL, BUT OBVIOUSLY THERE WAS AN ERA WHEN ANTIRETROVIRAL THERAPY WAS AVAILABLE OR EFFECTIVE, USING MACK PROPHYLAXIS MADE SENSE GIVEN FREQUENCY OF DISEASE. NOW ONCE YOU RECOGNIZE SOMEBODY WITH HIV THEY GET STARTED ON ANTIRETROVIRAL THERAPY. HOW MANY PEOPLE ARE GOING TO GET MACK? WHEN YOU GET SOMEBODY WHO IS SAID TO HAVE MACK IS THAT ACTIVE INFECTION OR IS THAT IMMUNE RECONSTITUTION SYNDROME? SO BASED ON OBSERVATIONAL DATA IT WOULD APPEAR BENEFIT FROM YOU GET FROM ERYTHROMYCIN IS SMALL IN SOMEBODY THAT ADHERES TO ANTIRETROVIRAL THERAPY. WE DON'T HAVE REALLY A RANDOMIZED TRIAL TO PROVE THAT BUT THAT'S CONSENSUS. >> THANKS. >> A COMMENT ON THE QUESTION. I JUST WONDER ALSO THAT MAYBE THE CONCENTRATION OF EXPOSING SOMEONE WITH MACK TO THERAPY MIGHT BE ANOTHER CONSIDERATION BECAUSE IF YOU HAVE MACK AND GIVE, THIS MIGHT BE A PROBLEM, THAT MIGHT BE ANOTHER FACTOR IN THE DECISION. >> I THINK RELATED QUESTION THAT I HAD FOR YOU, HENRY, WHICH WAS AROUND THE COMMENT YOU MADE ABOUT THE TB, SHORTENED TB GUIDELINES FOR HIV, AND WHEN THERE'S -- IF THE DATA IS WELL PRESENTED, WE HAVE A LOT OF DATA, IF THERE'S STILL A QUESTION THAT GUIDELINES COULD CHANGE BASED ON ABSTRACT WAITING FOR THE PAPER. SOUNDS LIKE IT'S A DEBATE THAT YOU'RE HAVING. >> WELL, WE DON'T WANT TO -- THERE WAS A -- (INAUDIBLE) THE POINT IS REALLY MAYBE I OVER EMPHASIZED WE WANT TO MAKE SURE THE DATA IS SOLID. WE OFTEN WILL TALK TO THE PRESENTER, AND LOOK AT MORE DATA, BUT I THINK IF THE DATA IS SOLID, AS IN THIS CASE IT APPEARS TO BE, I SUSPECT YOU'LL SEE A RECOMMENDATION. JOHN BROOKS REALLY DOES A TREMENDOUS AMOUNT OF WORK BEHIND THE SCENES TO MAKE SURE WE'RE NOT MARKEDLY DIFFERENT FROM WHAT THE CDC SAYS. IT MAY BE THE CDC ISN'T READY TO COMPLETELY ENDORSE IT WITH ENTHUSIASM YET. WE GIVE A MORE TEMPERED RECOMMENDATION BUT IN THE NEXT MONTH OR TWO YOU'LL SEE THE GUIDELINE. >> ALICE HAS A COMMENT. >> USING ABSTRACTING, NOT ALL ARE EQUAL, MOST ARE CONSIDERED NOT PEER REVIEWED, ONLY PEER REVIEW FOR 500 WORDS, WHATEVER IT IS IN THERE. WE REALLY WOULD HAVE TO LOOK AT EACH ABSTRACT INDEPENDENTLY. FOR INSTANCE, IF AN ABSTRACT SHOWS THERE'S HARM DONE TO A CERTAIN GROUP OF PATIENTS, WHICH ONE OF THE EXAMPLES OF THE ARV GUIDELINES THAT MAY EXTEND ON MAKING RECOMMENDATION WOULD BE WHEN THE SMART STUDY CAME OUT SHOWING DISCONTINUATION OF THERAPY IS HARMFUL, WE ENDORSED THAT BEFORE THE PUBLICATION BECAME AVAILABLE, WHEREAS THERE ARE A NUMBER OF ABSTRACTS WITH SMALL INDIVIDUALS, VIEWED DIFFERENTLY. >> DICK, PLEASE. >> WELL, FIRST, JUST IN TERMS OF ANNIVERSARIES, IN 1989 I REMEMBER HENRY REJECTING THE DATA IN AN ABSTRACT WE PRESENTED AT ICAC ON EFFECTIVENESS OF AEROSOLIZED PENTAMADINE. >> (INAUDIBLE). >> THAT'S EXACTLY WHAT YOU SAID. GIVEN BY LINDA'S ORGANIZATION IN BALTIMORE, WHICH WE'VE SHOWN ACTUALLY WAS SAVING LIVES. BUT YOU SAID NOT PUBLISHED, GO AWAY, SON. [LAUGHTER] SO I'M GLAD TO SEE THERE'S BEEN SOME EVOLUTION. [LAUGHTER] BUT THAT'S REALLY JUST AN ASIDE. MY QUESTION FOR ALICE IS, I'M REALLY CURIOUS, YOU KNOW, DRUG-DRUG INTERACTIONS WITH ERYTHROMYCINS OF GREAT IMPORTANCE, WE SAW AT CROIX THIS YEAR A NUMBER OF STUDIES WITH DALUTEGRAVIR, BICTEGRAVIR AND TAF. WITH BICTEGRAVIR IT DOESN'T LOOK LIKE THE COMPANY HAS INTEREST, ALL BUT THREE OF THE PEOPLE HAD PERFECTLY ADEQUATE EXPOSURES AND DIDN'T LOOK AT EFFECTIVENESS. THAT'S REMINISCENT OF THE EFAVERIN EXPERIENCE, NONSENSE ABOUT INCREASING DOSES THAT PROVED TO BE TOTALLY UNNECESSARY. MY QUESTION FOR YOU IS ABOUT TAF, GIVEN -- YOU HAVE A RECOMMENDATION AGAINST USE OF RIFOMYCIN WITH TAF BUT DATA AT CROIX LOOKS REMARKABLY GOOD SO I WONDER HOW YOU'RE GOING TO HANDLE THAT BEFORE IT'S PUBLISHED. >> SO IT WOULD BE INTERESTING, LOOKING AT KIM, WHO IS PART OF THE GROUP WHO WILL BE PUTTING TOGETHER OUR TABLES, AND AS YOU KNOW WE DON'T ALWAYS HAVE TO FOLLOW GUIDELINES FROM THE FDA PRODUCT INFORMATION, WHICH AN EXAMPLE WOULD BE EFAVERINS. WE LOOK AT DATA, COME UP WITH RECOMMENDATION, COULD BE CAUTIONARY TYPE OF LANGUAGE IN THERE, BUT WE WILL DEFINITELY -- AND LOCATIONALLY IT TAKES A LONG TIME FOR A LABEL TO BE CHANGED, DESPITE DATA THAT CAME OUT. SO WE'LL HAVE TO LOOK AT IT VERY CAREFULLY. >> JEN, DO YOU HAVE A COMMENT? OKAY, PLEASE, CHUCK. >> ROHAN, I WANT TO EXPRESS MY APPRECIATION TO YOUR COMMITTEE WHICH WORKED ARDUOUSLY TO REVIEW AND EXTEND GUIDELINES. FROM THE STANDPOINT OF POLICY, THEY WILL BE READY IN A MONTH OR TWO. DO THEY GO OUT OR NEED TO COME TO THIS COUNCIL FOR APPROVAL? >> I'LL HAVE LIZ TAKE THAT ON. >> SO THIS IS THE PRESENTATION TO THE COUNCIL FOR APPROVAL. THE UPDATE SIDES FROM EACH OF THE GUIDELINES IS WHAT THE COUNCIL WILL BE VOTING ON. SO IT'S A BROAD UPDATE THAT WAS PRESENTED. >> I WILL REMIND FOLKS ONCE THEY ARE PUBLISHED, THERE'S AN OPEN PUBLIC COMMENT PERIOD AS WELL. AND AS ALICE KNOWS, SOME YEARS WE GET A LOT OF COMMENTS, OTHERS YEARS VERY LITTLE. BUT THEY ARE ACTUALLY OPEN FOR PUBLIC COMMENT. WE LOOK AT THOSE COMMENTS AND THEN, YOU KNOW, TAKE THOSE UNDER CONSIDERATION. SOMETIMES WE WILL ACTUALLY ISSUE AN UPDATE RIGHT AWAY. OTHER TIMES WE SORT OF TAKE THAT UNDER ADVISEMENT AND MAKE WHATEVER CHANGES ARE NECESSARY WITH THE NEXT FULL PUBLICATION. >> JOHN, SORRY. PLEASE. >> I'M FAR AWAY. SO FIRST, I WANT TO COMPLIMENT ALL THREE COMMITTEES. IT'S REMARKABLE HOW USEFUL THESE GUIDELINES ARE. I MEAN, YOU PRESENTED DATA TO SHOW THAT. SOMEHOW IN MY MIND I'M MATHEMATICALLY MODELING THE NUMBER OF LIVES SAVED BECAUSE OF PEOPLE ADAPTING TO THE THOUGHTFUL GUIDELINES PRODUCED, I WANTED TO THANK YOU FOR THE ENORMOUS AMOUNT OF WORK, AND I KNOW AT LEAST A REPRESENTATIVE, DR. JOHN BROOKS, ENJOYS THE PROCESS. I JUST HAD A QUESTION, ALICE, PRIMARILY FOR YOU. IN OUR LAST MEETING WE TALKED ABOUT HOW THE HHS TREATMENT AND PREVENTION GUIDELINES PERHAPS CONSIDERING CLINICAL PRACTICE RECOMMENDATIONS REGARDING THE EFFECTIVE ANTIRETROVIRAL GUIDELINES, IF THAT'S COMING UP. >> JOHN BROOKS IS TALKING ABOUT THAT AT OUR RETREAT, THIS TOPIC THAT HE'S GOING TO BE DISCUSSING WITH OUR GROUP. WE HAVE IN THE WHEN TO START SECTION, A SECTION THAT TALKS ABOUT PREVENTION OF SECONDARY TRANSMISSION, AND INCLUDING SOME OF THE DATA, AND WE'RE GOING TO HAVE DISCUSSIONS ABOUT WHETHER THAT IS THE RIGHT PLACE TO TALK ABOUT IT BECAUSE PEOPLE ONLY GO TO WHEN TO START WHEN THEY INITIATE THERAPY BUT THIS GOES ALONG THE WHOLE CONTINUUM OF RECEIVING ANTIRETROVIRAL THERAPY, SO THIS IS GOING TO BE A TOPIC OF DISCUSSION. >> THIS WOULD BE A GOOD TIME TO VOTE, AND REALLY WHAT WE'RE VOTING ON IS TO APPROVE THE REPORT OF THESE. LINDA, ONE FINAL COMMENT BEFORE WE VOTE. >> I WANTED TO ASK YOU ABOUT YOUR COST EFFECTIVENESS GROUP AND IDEA THAT A NUMBER OF DRUGS ARE GOING TO BE GENERIC. SO A MOVEMENT IN THAT DIRECTION? >> WELL, YOU KNOW, THIS IS VERY COMPLICATED, AS YOU CAN IMAGINE. COST IS A VERY COMPLICATED ISSUE IN THE U.S. AND WE HAVE CONTINUOUSLY TALKED ABOUT -- THIS YEAR IS PROBABLY ONE OF THE BIGGEST YEARS BECAUSE OF A NUMBER OF GENERIC FORMULATIONS BEING APPROVED ALMOST EVERY MONTH YOU SEE SOMETHING NEW COMING UP. THIS IS ALSO A DISCUSSION THAT WE HAVE ONGOING RIGHT NOW, WHEN ARE WE GOING TO MAKE A STAND, AS YOU KNOW SOME OF THE GENERIC DRUGS ARE ALSO THE ONES WE'RE NO LONGER RECOMMENDING, WHAT WE CONSIDER TO BE INITIAL THERAPY FOR MOST PEOPLE. SO THAT BECOMES A LITTLE BIT MORE TRICKY. AS FAR AS EFFICACY VERSUS COST, SO WE HAVE CONTINUOUS DISCUSSIONS ABOUT THAT. >> ONE ISSUE, LINDA, THAT WE'VE DISCUSSED OVER THE YEARS, THESE PANELS ARE LARGELY CONSTITUTED BY CLINICAL EXPERTS. WE'RE NOT MANAGEMENT AND FINANCIAL EXPERTS. SO IT'S BEEN A DEBATE WHICH MANY OF US HAVE ENGAGED IN AS TO WHETHER THESE PANELS SHOULD ISSUE STATEMENTS ABOUT THIS. ALSO WE'RE ALL AWARE OF THE FACT COST CHANGES RAPIDLY FROM MONTH TO MONTH. SO WHETHER OR NOT THIS IS THE RIGHT VENUE TO GET INTO COST EFFECTIVENESS, I GUESS WE LISTENED WITH INTEREST TO WHAT THE SPONSORS AND ADVISORS HAVE TO SAY. >> OKAY. SO THIS IS THE TIME WE VOTE. IS ANYONE IN FAVOR OF -- WE'RE NOT GOING TO DO GUIDELINES IN DETAIL, BUT JUST APPROVING THE REPORTS THAT WERE PRESENTED. AND ANY -- WHO WOULD LIKE TO MOTION. YES, PLEASE, LYNN. SECOND. CHUCK, OKAY. ALL IN FAVOR. OKAY. THANK YOU. WE CAN HAVE THAT BREAK. LET'S TAKE A LITTLE BREAK, IT GOES TO 10:30. WE'LL TRY TO BE COMPLETELY ON TIME TODAY. THANK YOU. >> OKAY. THANK YOU. SO WE'RE GOING TO RESUME OUR PROGRAM. THE NEXT SECTION IS AN UPDATE ON THE AIDS STUDY SECTIONS BY DR. ROBERT FREUND, WHO WE'VE ALL HEARD FROM, CHIEF OF THE REVIEW GROUP CENTER FOR SCIENTIFIC REVIEW HERE AT NIH, LEAD SCIENTIST, ADMINISTRATIVE STAFF, MANAGED REVIEW FOR MAJORITY OF GRANT APPLICATIONS SUBMITTED TO NITTR, REVIEWING GRANT APPLICATIONS, AND WILL GO OVER THOSE STUDY SECTIONS AND ORGANIZATION RIGHT NOW. THANK YOU. >> THANK YOU FOR GIVING ME THIS OPPORTUNITY TO TALK TO YOU ABOUT REORGANIZATION AT CSR OF THE AIDS AND AIDS-RELATED RESEARCH STUDY SECTIONS. I'D LIKE TO TAKE A MINUTE TO ACKNOWLEDGE SOME OF THE PEOPLE WHO HAVE HELPED IN THIS ENDEAVOR, AND FIRST AND FOREMOST ENCOURAGE THE BY CSR, IN PARTICULAR DR. NAKAMURA, WHO IS IN THE AUDIENCE, WHO HAS HELPED, AND VALERIE DURAN, DIVISION DIRECTOR, WHO INITIATED THIS, AND HAS DONE MOST OF THE WORK. AND BOTH OF THEM HAVE ALLOWED ME TO GIVE THIS TALK TODAY. OTHER PEOPLE ARE THE SROs, AND MY WIFE WHO ALSO LISTENED AND WONDERED WHY I COULDN'T DO SOME HOUSEHOLD CHORES, I KEEP SAYING I'M WORKING ON THE REORGANIZATION. [LAUGHTER] BUT I WANT TO THANK EVERYBODY IN THE AUDIENCE. AS I LOOK AROUND, THERE'S A LOT OF PEOPLE WHO ARE INVOLVED IN HELPING WITH THIS REORGANIZATION, AND ALSO WHO ARE GOING TO BE AFFECTED BY THIS REORGANIZATION. SO WHAT I'M GOING TO DO IN THE NEXT 15 MINUTES IS REALLY TELL YOU ABOUT THIS REORGANIZATION, TELL YOU A LITTLE BIT ABOUT THE HISTORY OF THE STUDY SECTIONS, AND CURRENT STATE OF THE STUDY SECTIONS AND WHY WE DECIDED TO REORGANIZE, HOPEFULLY WHEN I TELL YOU ABOUT THE CURRENT STATE THAT YOU'LL SEE WHY WE DECIDED TO REORGANIZE AND THEN I'LL TELL YOU ABOUT THE PROCESS AND ALSO THE RESULT OF THE WORK THAT WE'VE DONE TO TRY TO REORGANIZE AND COME UP WITH THE DIFFERENT STUDY SECTIONS. SO JUST A SECOND -- SO AIDS AND AIDS-RELATED RESEARCH IRG WHICH STANDS FOR INTEGRATED RESEARCH GROUP, IS THE EQUIVALENT OF A BRANCH FOR THE ICs, AND SO WHAT WE ARE IS A GROUP OF SROs AND SUPPORT STAFF, AND WE REVIEW ALL THE APPLICATIONS THAT PERTAIN TO BASIC TRANSLATIONAL, CLINICAL AND BEHAVIORAL ASPECTS OF HIV AND AIDS RESEARCH TO THE CENTER FOR SCIENTIFIC REVIEW, THAT'S TO POINT OUT NOT ALL OF APPLICATIONS COME TO CSR, SOME REVIEWED IN IC REVIEW GROUPS, THIS DOES NOT PERTAIN TO ANY OF THOSE KIND OF REVIEW GROUPS. AND THE SECOND PART IS THAT ALL OF THE APPLICATIONS THAT COME TO CSR THAT ARE FROM THE HIV AND AIDS-RELATED APPLICATIONS COME, ARE REVIEWED ON EXPEDITED VIEW CYCLE, AND EITHER REVIEWED IN STUDY SECTIONS OR IN SPECIAL EMPHASIS PANELS, AND WHAT THAT MEANS IS THAT EVERY APPLICATION THAT COMES IN, WE RECEIVE IT, WE REVIEW IT, AND WE FINISH IT, WITHIN ONE COUNCIL ROUND SO IT CAN COME BACK THE NEXT COUNCIL ROUND. SO IT'S A LITTLE DIFFERENT THAN MANY OF THE OTHER TYPES OF REVIEWS. SO IT'S EXPEDITED. SO LET ME JUST TELL YOU A LITTLE HISTORY. IT'S A LITTLE INTERESTING, AT LEAST TO ME. IT ALL STARTED BACK IN 1987, AS ONE STUDY SECTION CALLED SPECIAL STUDY SECTION A. BASICALLY IT HAD IMMUNOLOGY AND VIROLOGY APPLICATIONS. AND WHEN CONGRESS MANDATED EXPEDITED REVIEW, IT WAS AT THE SAME TIME THEY MANDATED THE OFFICE OF AIDS RESEARCH. WE ESTABLISHED THREE STUDY SECTIONS WHICH WERE THE IMMUNOLOGY, VIROLOGY AND EPIDEMIOLOGY STUDY SECTIONS. BASICALLY OVER TIME WE'VE ADDED A FEW MORE, AND BASICALLY DRUG DISCOVERY, CLINICAL RESEARCH, AND NEUROSCIENCE AND BEHAVIORAL SCIENCE WERE ADDED, AND BASICALLY IN 2003, 15 YEARS AGO, WAS THE LAST TIME WE HAD ORGANIZED OR CHANGED THESE STUDY SECTIONS. WHAT WE ARE NOW ARE NINE STUDY SECTIONS. WE HAVE SOME CLINICAL AND EPIDEMIOLOGY, WE HAVE DRUG DISCOVERY, IMMUNOLOGY, MOLECULAR AND CELL BIOLOGY, AND VACCINE, NEURO, AIDS AND OTHER END ORGAN DISEASES, AND I'LL TALK A LITTLE BIT MORE, WE HAVE TWO BEHAVIORAL STUDY SECTIONS THAT DO -- ONE DOES PREVENTION, AND THE OTHER ONE DOES CONSEQUENCES, AND FOCUS ONLY ON BEHAVIORAL AND SOCIAL SCIENCES. SO, REALLY THE ORGANIZATION OF THESE STUDY SECTIONS, MANY OF THEM, I SHOW YOU FIVE OF THEM, THAT REALLY ARE PREDOMINANTLY BASIC AND TRANSLATIONAL, AND TRANSLATIONAL WE MEAN ANIMAL MODELS. AND THEY HAVE BEEN THIS WAY FOR A LONG TIME, WHERE WE'VE REALLY FOCUSED ON -- THERE'S BEEN A FOCUS ON THEIR BASIC NATURE, BASIC SCIENCE NATURE, AND THEN WE HAVE A FEW, AIP OR WHICH IS AIDS AND IMMUNOLOGY AND PATHOGENESIS, THAT ONE HAS SLOWLY BECOME A LITTLE BIT MORE CLINICAL, AND THEN WE'VE HAD THREE STUDY SECTIONS THAT REALLY HAVE BEEN CLINICAL AND POPULATION STUDIES, ALMOST EXCLUSIVELY. SO THIS IS THE WAY WE SITUATED NOW, AND JUST TO GIVE YOU AN EXAMPLE, WE GET ABOUT 2,000 APPLICATIONS A YEAR, OR ABOUT 700 EACH COUNCIL ROUND, AND OF THAT, 400 TO 500 GO TO STUDY SECTIONS, AND WE HAVE OTHER STUDY SECTIONS THAT COVER SOME OF IT, BUT THERE'S QUITE A BIT OF APPLICATIONS, AS MANY AS 200, 200 APPLICATIONS THAT COME IN ON RFAs AND PARs. AND OVER THE LAST COUPLE YEARS, THAT NUMBER HAS SORT OF INCREASED, ALTHOUGH IT DOESN'T LOOK THAT WAY. SO WE GET -- WE HAVE 10 -- SOMETIMES OVER 10 MEETINGS COVERING THE PARs AND RFAs, WHICH REPRESENT EMERGING AREAS AND THINGS LIKE THAT. SO, LET ME JUST SHOW YOU A LITTLE BIT OF WHAT -- THE REASONS WE FINALLY DECIDED TO REORGANIZE. IF YOU LOOK AT DRUG DISCOVERY, THIS IS TWO GRAPHS. THEY SHOW YOU BOTH THE VACCINE STUDY SECTION AND THE DRUG DISCOVERY SECTION, AND MOLECULAR BIOLOGY ONE AND PATHOGENESIS ONE. BUT WHAT I WOULD LIKE TO POINT OUT IS A NUMBER OF APPLICATIONS THAT WE GET EACH COUNCIL ROUND. AS YOU CAN SEE, THE MOST EXTREME IS THE VACCINE STUDY SECTION, WHERE WE RARELY GET 30 APPLICATIONS AROUND. AND EVEN WHEN YOU THINK ABOUT IT WITH IMMUNOLOGY AND PATHOGENESIS, THAT ONLY GIVES US ABOUT 40 APPLICATIONS, AND AMCB AND , 30 TO 35 FROM EACH STUDY SECTIONS AROUND. THAT'S A LITTLE BIT DIFFERENT WITH NEURO, AIDS, AND ORGAN DISEASES WHICH FLUCTUATE MORE, AND AIDS AND OPPORTUNISTIC INFECTION AND CANCER BUT THEY ALSO ARE AVERAGING ABOUT 40 APPLICATIONS AROUND EACH. SO THAT -- THE APPLICATIONS THAT FOCUS ON BASIC SCIENCE AND TRANSLATIONAL STUFF SEEMS TO BE ONLY ABOUT -- THIS IS TWO YEARS WORTH. THEY SEEM TO BE PRETTY CONSISTENT AND THEY ARE 30 TO 50 APPLICATIONS AROUND IN THOSE STUDY SECTIONS. NOW THE THREE MORE CLINICAL STUDY SECTIONS HAVE MANY MORE APPLICATIONS, THE TWO BEHAVIORAL SCIENCE ONES, EACH ROUND HAVE -- AVERAGE AROUND 70 APPLICATIONS, AND ACE, WHICH IS CLINICAL SCIENCE AND EPIDEMIOLOGY THAT VARIES AGAIN FROM ROUND TO ROUND, BUT AGAIN HAS NOW BEEN ABOUT 60 APPLICATIONS, OR 65 APPLICATIONS FOR THE LAST YEAR OR SO. SO, REALLY THE REASON WE WANTED TO REORGANIZE IS A COMBINATION OF TWO THINGS. ONE IS THE STATE OF THE STUDY SECTIONS, THE WAY I DESCRIBED IT, AND ALSO THAT BASICALLY TO TRY TO ALIGN WITH THE CURRENT STATE OF THE SCIENCE TODAY, AS I SAID, FOR THE LAST 15 YEARS WE HAVE NOT REORGANIZED. AND ALSO ADMINISTRATIVELY IT IS BASICALLY TO TRY TO REALIGN TO SUPPORT THE -- TO INCREASE THE SCIENTIFIC BREADTH AND HELP WITH MEETING MANAGEMENT SO WE HAVE 60 TO 80 APPLICATIONS PER STUDY SECTION. AND ALSO TO TRY TO INCORPORATE SOME OF THE EMERGING SCIENTIFIC AREAS AND SPECIAL TOPICS WITHIN THESE STUDY SECTIONS SO THAT MAYBE WE'LL HAVE LESS PARs AND RFAs AND CAN INCORPORATE THEM INTO THE STUDY SECTION. SO, ALTHOUGH THIS IS A GROUP I PROBABLY DON'T HAVE TO EXPLAIN ABOUT HOW THE SCIENCE HAS CHANGED, BUT AS YOU ALL KNOW THE SCIENCE HAS CHANGED FROM THE LAST 15 YEARS FROM ACUTE DISEASE TO CHRONIC INFECTION, SO THE SCIENCE HAS CHANGED, AND THERE'S A GREATER EMPHASIS ON CURE, ON RESERVOIR ELIMINATION, AND PERSISTENCE OF VIRUS, PREVENTION, INTERVENTION, SUCH AS VACCINE AND THERAPEUTICS, AND CERTAINLY PrEP AND TREATMENT AS PREVENTION AND THEN THE PEOPLE LIVING WITH HIV-INFECTED, THEY HAVE COMORBIDITIES AND CO-INFECTIONS, AND CARE CONTINUUM AND SERVICE DELIVERY. WHAT WE'VE SEEN IS THAT THE SCIENTIFIC SCOPE HAS BECOME MUCH MORE INTERDISCIPLINARY AND OVERLAPPING AND HAS COVERED MUCH OF THE SCIENCE COVERS BOTH BASIC AND CLINICAL, WITHIN THE SAME APPLICATIONS. SO IT'S SOMETHING THAT WE HAVE TRIED TO INCORPORATE AND TRIED TO HAVE A MORE BENCH-TO-BEDSIDE APPROACH WITH WHEN WE'VE TRIED TO ORGANIZE THESE STUDY SECTIONS. THE WAY WE'VE DONE THE PROCESS, WE'VE INCORPORATED HELP FROM EVERYBODY, ESPECIALLY PEOPLE INVOLVED IN THE OFFICE OF AIDS RESEARCH, AND ICs, AND WE STARTED WITH INTERNAL REVIEW AND ASSESSMENT, WHICH IS BASICALLY LOOKING AT THE NUMBERS AND LOOKING AT THE APPLICATIONS THAT ARE COMING IN, AND WE USED A SMALL EXTERNAL WORKING GROUP, TO COME IN. IT SEEMS LIKE YESTERDAY BUT I GUESS IT WAS IN MAY. AND WE ASKED THEM TO HELP US WITH LOOKING AT THESE STUDY SECTIONS. WE GAVE THEM SOME OF THE INFORMATION ABOUT WHAT'S COMING IN A LITTLE BIT MORE EXACT, AND SOME OF THE NUMBERS. AND WE TOOK THEIR RECOMMENDATIONS AND MADE SOME REFINEMENTS IN THE ORIGINAL PLAN THAT WE HAD COME UP WITH, AND THEN WE ASKED THE ICs TO HELP US AS WELL, AND WE FIRST STARTED WITH OFFERING PROGRAM OFFICERS AND PEOPLE IN THE OFFICE OF AIDS RESEARCH TO COME IN ON WHAT WE CALL AN IAM MEETING BUT WHAT IT REALLY IS IS A CHAT GROUP. WE GAVE THEM THE INFORMATION. WE GAVE THEM WHAT WE WERE THINKING. AND WE ASKED FOR COMMENTS. IT WAS OPEN I THINK FOR ABOUT A WEEK. AND PEOPLE MADE COMMENTS. THEY LOOKED AT THE INFORMATION. AND THEN WE INCORPORATED A SMALL WORKING GROUP, AND TALKED TO THEM AND TRIED TO SEE WHAT THEY FELT, AND WE CAME UP WITH WHAT WE CALL PLAN 2, AND WE REASSESSED AND CHANGED IT A LITTLE BIT, AND WE PRESENTED IT TO THE ADVISORY COUNCIL. WE WENT AND TALKED TO MAUREEN AND WE GOT SOME INPUT FROM SENIOR PEOPLE AT ICs, AND BASICALLY CAME UP WITH A PLAN. AND IN THE LAST COUPLE MONTHS I'VE BEEN WORKING ON THE STUDY SECTION DESCRIPTIONS, AND THE NAMES, AND HAVE CERTAINLY BEEN STRUGGLING WITH NAMES. I THINK YESTERDAY WE GOT A TALK ABOUT SOMEBODY WHO HAD GREAT NAMES LIKE STAR, BUT OURS ARE NOT AS INNOVATIVE. WE PUT TOGETHER THAT. AND THEN OVER THE LAST COUPLE WEEKS I'VE SENT OUT A MUCH MORE DETAILED ANALYSIS OF HOW WE'RE GOING TO PUT THE STUDY SECTIONS TOGETHER, WITH DESCRIPTIONS AND BULLETS, AND WE'VE SENT IT OUT TO OVER 100 PEOPLE AND BOTH AT THE I.C. LEVEL AND REVIEWERS, AND CAME BACK AND I WENT THROUGH ALL OF THEM AND TRIED TO INCORPORATE SOME OF THEM, AND WHEN WE PUT -- RATHER THAN JUST TELL YOU WHAT IT IS, I'M GOING TO TELL YOU -- HOLD YOU IN SUSPENSE HERE. [LAUGHTER] SO ALTHOUGH WE DID MOST OF THE REORGANIZATION, BASED ON APPLICATIONS AND WHAT WE'VE SEEN, WHEN WE WERE DONE WITH THIS ORGANIZATION WE FOUND THAT WE ALIGNED OURSELVES VERY CLOSELY WITH WHAT WE CONSIDER TO BE THE OFFICE OF AIDS RESEARCH PRIORITIES. AND SO WE WERE PRETTY HAPPY THAT WE CAME OUT WITH THE SAME, AND LIKE I SAID, EVEN MAUREEN AGREED WE DID A GOOD JOB OF COMING UP. SO HERE IS WHAT WE CAME UP WITH. WE DID COME UP WITH, AGAIN, AS I SAID, A MORE BENCH-TO-BEDSIDE APPROACH. WE HAVE A STUDY SECTION THAT IS MORE BASIC SCIENCE, WHICH WILL COVER THE MOLECULAR VIROLOGY, CELL BIOLOGY AND DRUG DEVELOPMENT. THEN THREE STUDY SECTIONS THAT ARE BASICALLY COVERING, AGAIN, THESE COVER BASIC TWO CLINICAL STUDIES. WE HAVE IMMUNOPATHOGENESIS AND VACCINE DEVELOPMENT. AND ANOTHER ONE, COMORBIDITIES AND CLINICAL STUDIES. CO-INFECTION AND ASSOCIATED CANCERS. AND THEN WE'VE TAKEN THE OTHER TWO, WHICH GO INTO POPULATION STUDIES, WHERE WE HAVE BASICALLY DETERMINANTS AND BEHAVIORAL INTERVENTION AT THE MORE INDIVIDUAL LEVEL AND THEN EPIDEMIOLOGY, POPULATION AND PUBLIC HEALTH APPROACHES, AND THE OTHER LEVEL. SO THIS IS JUST TO MIMIC THE FIRST SLIDE, AND SOME OF THESE COVER AREAS THAT ARE -- THEY DON'T USE THE WORDS, BUT WE HAVE IN EPIDEMIOLOGICAL POPULATION PUBLIC HEALTH APPROACHES. WE'VE INCORPORATED IMPLEMENTATION SCIENCE, AS WELL AS MODELING, AND SOME OF THE OTHER ISSUES. CO-INFECTION HAS -- GOES FROM NEUROCOGNITIVE STUDIES TO HEART AND LUNG. TRYING TO THINK OF SOME OF THE HIGHLIGHTS HERE. BUT IMMUNOPATHOGENESIS WILL COVER BOTH IMMUNE RESPONSE AS WELL AS SOME OF THE BASIC -- MORE BASIC VACCINE STUDIES, BUT WHEN IT STARTS TO GET MORE IN THE CLINICAL SIDE IT WILL START TO MOVE OVER TO COMORBIDITIES AND CLINICAL STUDIES, SO WE SEEM TO TRY TO COVER MOST OF THE AREAS BASED ON WHAT WE GET. OKAY. SO I THINK THIS IS CLOSE TO THE LAST SLIDE. LET ME TELL YOU WHERE WE ARE. SO WE HAVE THESE NAMES. WE'RE STILL TWEAKING THEM AND TRYING TO INCORPORATE SOME OF THE BASICALLY BULLETS TO THIS, TO MAKE SURE EACH OF THE STUDY SECTIONS ARE INCORPORATING A LOT OF THE STUFF THAT WE GET, AND ALSO WE HAVE BEGUN TO DO WHAT'S CALLED MOCK SORT, WHICH WHAT THAT MEANS IS WE'VE TAKEN ALL THE APPLICATIONS WE'VE GOTTEN THIS ROUND, AND WE SORTED THEM TO THE NEW STUDY SECTIONS TO SEE HOW IT WORKS OUT, AND AT LEAST PRELIMINARILY, WE ARE AT ABOUT WHAT WE WERE LOOKING FOR, THAT EACH OF THE STUDY SECTIONS HAVE BETWEEN 60 AND 80, SOME ARE A LITTLE DIFFERENT. VALERIE AND I DON'T ALWAYS AGREE, SO VALERIE WINS. [LAUGHTER] BUT THAT'S JUST IN THE MOCK SORT. SO WE ARE STILL TRYING TO MAKE SURE THAT WE ARE DOING THAT. SO, AS PEOPLE CAME UP TO ME BEFORE THE TALK AND SAID, WELL, WHAT'S HAPPENING, YOU KNOW, WHEN IS THIS HAPPENING, SO WE'RE GOING TO START TO COMMUNICATE THESE CHANGES MORE OFFICIALLY AND TRY TO TELL THE REVIEWERS THAT WE HAVE WHERE THEY ARE GOING, AND HOW WE'RE GOING TO PUT THESE TOGETHER, AND TALK TO THEM A LITTLE BIT MORE ABOUT HOW THINGS WILL FALL OUT. WE WILL START TO ADVERTISE THE NEW STUDY SECTIONS MORE BROADLY, WE WILL POST THEM ON THE WEBSITE. WHEN I SAW ROHAN AND HENRY'S PRESENTATION I THOUGHT IT COULD HAVE HAD ONE MORE SLIDE TO SEE HOW MANY PEOPLE GO TO OUR WEBSITE. BUT I THINK ONCE WE PUT THESE NEW STUDY SECTION DESCRIPTIONS ON THERE WE SHOULD GET MORE. SO THE NEXT TIME YOU INVITE ME, I WILL HAVE THAT SLIDE. AND WE WILL THEN MORE OFFICIALLY COME UP WITH THE ROSTERS AND MEMBERSHIP ASSIGNMENTS WITH THE HELP OF WHAT WE CALL BUILDING 1. WE HAVE TO GET EVERYTHING APPROVED. AND WE'RE HOPING TO HAVE THE FULL -- WELL, NOT HOPING. WE WILL HAVE THE FULL IMPLEMENTATION OF THIS THING, WHETHER IT KILLS ME OR NOT, IN WHAT WE CALL THE 2019-01 COUNCIL ROUND, SEPTEMBER RECEIPT DATE WITH STUDY SECTIONS IN PLACE AND GOING FOR THE NOVEMBER 2018 STUDY SECTION. SO I DON'T REALLY MEAN QUESTIONS. >> STEPHANIE? >> FIRST, I WANT TO COMMEND YOU. THIS IS A BIG JOB. IT WAS LONG OVERVIEW. A NUMBER OF US IN THIS ROOM COULD SEE THERE WAS A LOT OF OVERLAP BETWEEN SOME OF THE STUDY SECTIONS AND IT LED PEOPLE TO KIND OF, YOU KNOW, TRY TO STEER GRANTS TO CERTAIN PLACES ON THEIR OWN RATHER THAN LETTING CSR DO IT'S JOB. TO ME IT LOOKS LIKE A REASONABLE BREAK IN TERMS OF, YOU KNOW, THE BASIC SCIENCE, CLINICAL SCIENCE, EPIDEMIOLOGY, SOCIAL SCIENCES, AND, YOU KNOW, I'M GLAD TO SEE THAT THE MOCK -- LARGE ENOUGH TO GIVE YOU THE GENERAL SENSE THIS IS GOING TO WORK OUT SO YOU DON'T HAVE 90 GRANTS GOING TO ONE IRG OR DO YOU NEED TO GO BACK OVER THE LAST YEAR. >> SO BASED ON THIS MOCK SORT, I DON'T THINK I HAVE THE STRENGTH TO DO TWO. WE WILL TRY TO MOVE THE BULLETS AND MAKE SURE SOME OF OUR NUMBERS FLUCTUATE, NOT SO MUCH, EVEN ON BEHAVIORAL, BUT SOME FLUCTUATE BECAUSE WE GET -- WHEN PARs AND RFAs END, THEY COME IN FOR ONE ROUND, THEN WE GET, I DON'T KNOW THE WORD, LEFTOVERS, SO THAT WILL CAUSE SOME FLUCTUATION. BUT I THINK OVER THE YEARS EVEN THOUGH THOSE SCALES WERE BIG, I THINK THERE'S BEEN FOR THE FIVE YEARS THAT I'VE BEEN DOING THIS, OR SIX YEARS NOW, THEY ARE PRETTY STABLE. AND THE TYPES OF APPLICATIONS WE GET HAVE BEEN STABLE. THE LINES HAVE GOTTEN FUZZIER, AS YOU MENTIONED, BUT THE NUMBERS SEEM TO STAY THE SAME. >> YES, SO THANKS FOR THE OVERVIEW. WE'VE ALL BEEN ANXIOUSLY WAITING FOR THIS TYPE OF THING, ESPECIALLY MEMBERS OF THE STUDY SECTION. I HAVE TWO BRIEF QUESTIONS. SO HOW MANY PEOPLE NOW ARE GOING TO BE ON STUDY SECTION PER GROUP, IF YOU'RE MOVING FROM NINE STUDY SECTIONS TO SIX, I'M ASSUMING YOU'RE HAVING BIGGER GROUPS SO WHAT DOES THE NUMBER LOOK LIKE FOR THAT? >> THE NUMBER OF REVIEWERS? >> YES. >> SO WE TRIED TO COORDINATE WITH -- SO EVERY YEAR WE HAVE A NEW GROUP THAT GOES OFF. WE'VE BEEN TRYING TO COORDINATE THAT. AND WE DON'T FORESEE THAT STUDY SECTION. THE NUMBERS WILL BE APPROPRIATE. SO FOR 70 APPLICATION STUDY SECTION WE HAVE ABOUT 25, 20, SOMEWHERE AROUND 20 MEMBERS, AND THEN WE WOULD GET AD HOC MEMBERS TO MAKE UP THE EXPERTISE THINGS. >> AND MY OTHER QUESTION IS, CAN YOU BRIEFLY DESCRIBE WHAT THE DIFFERENCE BETWEEN THE CO-INFECTION AND COMORBIDITY GROUPS ARE. YOU MENTION CO-INFECTION, YOU SAID BRAIN AND HEART, BUT THEN TO ME I WAS THINKING THOSE WOULD BE MORE COMORBIDITY. >> I'M SORRY, THEN I SAID THAT WRONG. HEART, LUNG, AND COMORBIDITIES, HIV AND TB WOULD BE CO-INFECTION, HIV AND HCV ARE APPLICATIONS COMING IN MORE AND MORE IN THAT DIRECTION. THOSE WOULD BE IN CO-INFECTION, AND THEN WE GET QUITE A FEW OF OPPORTUNISTIC INFECTIONS AND VIRUSES THAT COME IN. YES. >> THANKS FOR THAT PRESENTATION. I WAS CURIOUS AS TO I SAW IN THE NEW STUDY SECTION NAMES THERE'S NO WORD "PREVENTION" IN THERE, I WAS CURIOUS AS TO WHETHER THAT WAS A BIG DISCUSSION, AND IN YOUR MOCK SORT DOES PREVENTION NOW FALL IN ALL THE STUDY SECTIONS? HOW IS THAT WORKING OUT? >> SO YOU'RE RIGHT, NOW THAT I LOOK AT THEM, THERE IS NO -- THE WORD "PREVENTION" ISN'T THERE, BUT CERTAINLY THE -- WHAT WE CALL -- I'M TRYING TO MEMORIZE. HIBI, EASIER THAN READING THE WHOLE THING, THAT HAS MANY OF THE APPLICATIONS THAT ARE BEHAVIORAL AND SOCIAL SCIENCE PREVENTION, AND SOME OF THE OTHER TYPES OF PREVENTION WOULD FALL UNDER IMMUNOPATHOGENESIS, BUT I THINK THE PREVENTION THAT YOU'RE REFERRING TO WOULD FALL BOTH IN HIBI AND THE PPH. YOU KNOW, I'M STILL USED TO THE OTHERS. I HAVE TO LOOK AT THESE BECAUSE THEY DON'T COME NATURALLY. >> RALPH, YOU HAD A QUESTION. >> COMMENDABLE JOB. I'M SURE IT WAS NO SMALL TASK, YOUR WIFE WILL ATTEST TO THAT I'M SURE. BUT THE CATEGORIZATIONS THAT YOU'VE USED, CLASSIFICATIONS BETTER REFLECT EVOLVING HIV EPIDEMIC, WHICH AS YOU SAY MAPS ON NICELY WITH THE OAR PRIORITIES THAT ARE DESIGNED TO ADDRESS THE CHANGING EPIDEMIC. HYPOTHETICAL QUESTION, I GUESS YOU'RE GOING TO GET A LOT OF THESE AS YOU GO DOWN THE ROAD. FOR EXAMPLE, HIBI, IF A PERSON WAS DESIGNING A BEHAVIORAL INTERVENTION TO REDUCE ALCOHOL OR DRUG USE, AMONG PEOPLE WITH HIV, FOR EXAMPLE AS A WAY OF REDUCING THE IMPACT OF HCV CO-INVECTION, WOULD THAT STILL BE AN HIBI OR IN A COMORBIDITIES? >> SO WE WOULD HAVE TO LOOK VERY CLOSELY AT THE APPLICATION AND TRY TO FIND OUT WHAT THE FOCUS IS, IF IT REALLY IS SOLVING A PREVENTION BETWEEN HIV AND HCV WOULD GO THERE BUT IF IT'S A PRE- PREVENTION IN GENERAL SENSE WOULD GO TO HIBI. WE WOULD LOOK AT THESE APPLICATIONS AND WHAT WE'RE HOPING WHEN WE POST THE THINGS WITH THE BULLETS, PEOPLE WILL BE ABLE TO MAKE A JUDGMENT AND I GUESS I'LL BE ANSWERING THOSE QUESTIONS. >> CHUCK, YOU HAD A QUESTION. >> THANK YOU. CHUCK WEIR. I REALIZE THAT CHANGE DOESN'T COME EASY, AND THAT IT'S IMPORTANT THAT CHANGE DOES TAKE PLACE. BUT I'M REALLY CONCERNED THAT MAJOR AREAS THAT HAVE BEEN UNDERINVESTIGATED HAVE BEEN COMPACTED DOWN INTO ONE BASIC SCIENCE STUDY SECTION, MOLECULAR BIOLOGY, CELL BIOLOGY AND DRUG DEVELOPMENT. HIV IS A SEXUALLY TRANSMITTED DISEASE, MUCOSAL IMMUNOLOGY IS STILL A VASTLY UNDERESTIMATED AREA, WE'RE JUST SCRATCHING THE SURFACE WITH THE MICROBIOME MUCH LESS UNIQUE CHARACTERISTICS PRESENT. THAT BEING SAID, PARTICULAR AREA OF INTEREST IN MY LIFE IS WOMEN AND GIRLS, GROSSLY UNDERREPRESENTED IN MOST STUDY SECTIONS, MOST FUNDING AGENCY AND MANY OF THE YOUNG INVESTIGATORS I KNOW WOULDN'T BE ALIVE TODAY IF IT WASN'T FOR RFAs. AND I THINK THAT I COULD GO ON WITH THE LIST BUT I THINK IT IS REALLY VERY IMPORTANT TO MAKE SURE THAT THERE'S A WAY THAT THESE THINGS ARE INCLUDED, NOT JUST AS AFTERTHOUGHTS. I CAN SEE IN A STUDY SECTION OF 35 OR 40 PEOPLE THE FOUR TOPICS I MENTIONED, I DIDN'T MENTION THE ELDERLY, AN EXPLODING AREA WITHIN THIS COUNTRY, ARE NOT GOING TO REALLY GET MUCH ATTENTION WITHOUT SOME REEMPHASIS OF WHAT'S GOING ON HERE. >> I THINK IT'S THE OPPOSITE. SO WE HAVE TRIED TO INCLUDE SOME OF THESE TOPICS THAT YOU JUST MENTIONED, AND IN PARTICULAR IN THE IMMUNOPATHOGENESIS SHOULD COVER, WE SHOULD CERTAINLY HAVE MUCOSAL IMMUNITY AND MICROBIOME, AND IN THE COMORBIDITIES WE'LL CERTAINLY HAVE THE AGING AND SO I DIDN'T GO THROUGH THE BULLETS, AND WE'RE STILL TWEAKING THE BULLETS BUT THESE ARE SPECIFIC BULLETS I'VE PUT IN BECAUSE I DO REALIZE TIMES ARE CHANGING AND WE HAVE TO CHANGE WITH THEM. THAT'S THE GOAL, TO INCORPORATE THINGS INTO STUDIES AND WE HAVE REVIEWERS THAT WILL SEE THE IMPACT OF THESE, WHAT THE IMPACT HAS AND WILL BE. >> IT'S HARD TO SUMMARIZE EVERYTHING GOING INTO EACH SECTION. WHAT THE BULLETS WILL SHOW US IN MAY WHEN YOU POST ON THE WEBSITE IS EXACTLY WHAT CHUCK ASKED FOR, THE GREATER DETAIL ON WHAT WOULD BE COVERED UNDER EACH SECTION. FEELS LIKE WE COULDN'T COVER THAT HERE IN THIS SHORT TALK BUT SOUNDS LIKE THIS WAS AN ATTEMPT TO BE MORE INCLUSIVE RATHER THAN -- >> IF YOU'RE THINKING ABOUT THESE THINGS, IT'S GREAT, BUT IT REALLY NEEDS TO BE BROUGHT OUT. SO I LOOK FORWARD TO SEEING THE NEXT ITERATION OF THIS. >> ME TOO. [LAUGHTER] >> ONE QUICK QUESTION TO END, SORRY, AND I'LL GO TO INGRID, CURRENT STUDY SECTION MEMBERS WILL STAY STUDY SECTION MEMBERS BECAUSE IF THEIR TERMS SPAN SEPTEMBER 2018 -- >> YES. >> THEY CAN FOLD INTO A NEW GROUP. >> A TEST. IF THEY CAN REMEMBER THE NEW -- THEN WE KEEP 'EM. >> OKAY, GOOD. PLEASE. >> I JUST WONDERED IF YOU ANTICIPATED THE EXPEDITED HIV DEADLINES REMAINING REALITY. >> SAY AGAIN, I'M SORRY. >> SORRY. I WONDERED IF YOU ANTICIPATE THE EXPEDITED HIV DEADLINES WILL REMAIN. >> CONGRESS DID THIS THE FIRST TIME, MY INPUT IN THIS IS ABOUT THE SAME AS IT WAS IN 1988. SO IF YOU CAN CONVINCE CONGRESS TO CHANGE IT, WE'LL CHANGE IT. >> WE DON'T WANT IT CHANGED. >> DON'T CHANGE IT. >> I DON'T ANTICIPATE, BUT I HAVE NOTHING TO DO WITH IT. >> OKAY. STEPHANIE. >> I ECHO THE WORD "PREVENTION" IS MISSING WHICH OBVIOUSLY IS IMPORTANT, BUT ALSO THE SOCIAL SCIENCES, YOU KNOW, DOESN'T NEATLY FIT IN. I'M WONDERING IF SOME THOUGHT HAS BEEN GIVEN TO THAT. FOR EXAMPLE, IN THE HIBI, IT WOULD BE HIV/AIDS INDIVIDUAL, SOCIAL, SOCIAL LEVEL DETERMINANTS, AND BEHAVIORAL INTERVENTIONS, BUT THAT'S JUST ONE SUGGESTION. IS IT POSSIBLE FOR US TO SEE THE FULL BULLETS THAT ARE GOING TO BE LINKED TO EACH ONE OF THOSE IRGs? >> WE'RE STILL CHANGING THEM BUT YES. I'D BE HAPPY TO SEND THEM TO YOU IN PARTICULAR, BUT ALSO ANYBODY ELSE. >> I'D BE HAPPY TO GIVE ADDITIONAL FEEDBACK. THANKS SO MUCH FOR THE OPPORTUNITY. >> THANK YOU. >> OKAY. THAT WAS GREAT. THANK YOU. AND SO OUR NEXT SECTION TOPIC INTRODUCED A COUPLE TIMES AGO IS TASK FORCE FOR COST SHARING SECTION. REMEMBER THIS GOT BROUGHT UP WITH DR. PETER KIM, AND WE HEARD NOW PROBABLY TWO MEETINGS WHERE WE TALKED ABOUT THIS, AND NOW TODAY WE'RE GOING TO HEAR FROM DR. JEAN PATTERSON, L. JEAN PATTERSON, ABOUT THE TASK FORCE RECOMMENDATION FOR COST SHARING, SHE JOINED ON THE HIV/AIDS COMMITTEE AS ADVISOR AND LET PORTFOLIO REVIEW IN 2015, AFTER DR. FRANCIS COLLINS RELEASED GUIDE NOTICE AND LAST YEAR WAS PROMOTED AS CO-LEAD FOR REDUCING INCIDENCE SECTION AND MORE RECENTLY NOW SERVES AS LEAD OF THE OAR COST SHARING TASK FORCE. THIS WE TALKED ABOUT ON FRIDAY IN OUR CALL. THIS WOULD BE THE PRESENTATION, VERBAL PRESENTATION, OF THE RECOMMENDATIONS BY THE TASK FORCE AND LATER THIS GROUP WILL REVIEW THE POLICY DOCUMENT IN DUE COURSE. THIS IS REALLY THE TASK FORCE'S RECOMMENDATIONS THAT WE'RE REVIEWING IN PRESENTATION FORM. >> THANK YOU, MONICA. GOOD MORNING, EVERYONE. I'M PLEASED TO BE ABLE TO PRESENT A SUMMARY OF THE FINAL RECOMMENDATIONS FOR THE OAR COST SHARING TASK TO ALL OF YOU FOR YOUR INFORMATION AND COMMENT, I THINK. BEFORE I DO THAT THOUGH I'D LIKE TO REMIND EVERYONE OF THE STEPS WE'VE ALREADY TAKEN AND WE PLAN TO TAKE IN THE FUTURE TO ACHIEVE OUR GOAL OF DEVELOPING A TRANS-NIH HIV COST SHARING POLICY. AS EARLY AS 2015, WE IDENTIFIED THE NEED FOR COST SHARING USING OUR AIDS DESIGNATED DOLLARS. AND AT THE END OF 2017, WE FORMED AN AD HOC COST SHARING TASK FORCE MEANT TO PROVIDE RECOMMENDATIONS FOR COST SHARING STRATEGIES DIRECTLY TO THE OAR, AS ONE PIECE OF OUR INFORMATION GATHERING PROCESS. SO THEY DELIVERED THOSE RECOMMENDATIONS TO US LAST MONTH, AND THIS IS WHERE WE ARE NOW. WE'RE GOING OUT TO OUR STAKEHOLDERS FOR COMMENT. AND OUR GOAL HERE IN THE PROCESS IS TO KEEP YOU INFORMED, AND TO GET YOUR FEEDBACK OBVIOUSLY. AND WE'VE ALREADY SHARED A SUMMARY OF THESE RECOMMENDATIONS WITH OUR AIDS EXECUTIVE COUNCIL, AND TODAY NOW OUR OARAC, IN THE COMING WEEKS WITH NIH LEADERSHIP. SO BASED ON INPUT FROM ALL OUR STAKEHOLDERS, OAR WILL THEN WORK WITH NIH LEADERSHIP TO FINALIZE TRANS-NIH POLICY ON COST SHARING AND THEN IMPLEMENT IT. SO BY WAY OF BACKGROUND, I'D LIKE TO PROVIDE HISTORICAL CONTEXT TO ILLUSTRATE HOW WE GOT WHERE WE ARE. MOST OF YOU KNOW ALREADY IN 2015 DR. COLLINS RELEASED BOTH STATEMENT AND GUIDELINES IN THE NOTICE LISTED HERE. THE STATEMENT OUTLINED OUR NEED TO FOCUS PRIORITIES FOR HIV RESEARCH, AND GUIDELINES WERE HELPFUL IN DETERMINING HOW TO ALIGN THOSE PROJECTS WITH THE PRIORITIES. SO THAT OF COURSE LED OAR TO REDEFINE AND FOCUS OUR RESEARCH PRIORITIES. FROM NINE SEPARATE AREAS OF SCIENCE TO FIVE COMPLEMENTARY AREAS, ALLOWING TO WORK COLLABORATIVE AND IN A CROSS-DISCIPLINE WAY TO ACHIEVE OUR GOAL, TO FUND RESEARCH THAT WILL HAVE THE GREATEST RELEVANCE TO END THE PANDEMIC AND IMPROVE THE LIVES OF PEOPLE WITH HIV. CLEARLY ADVANCES IN ANTIRETROVIRAL THERAPY CHANGED THE LANDSCAPE FOR PREVENTION AND EPIDEMIC ITSELF, CERTAINLY CHANGED TO INCLUDE PEOPLE EXPOSED AND AT RISK AND THOSE REPLACED ON LONG-TERM PrEP. AFTER THE NOTICE WAS ISSUED A TASK WAS PORTFOLIO REVIEW OF PROJECTS IN OUR DATABASE HIGHLIGHTING FOR US THE COMPLEXITY OF OUR HIV-FUNDED RESEARCH, AND THIS IS REALLY JUST A STOCK PHOTO OF A CLUSTER ANALYSIS, BUT FOR ME GRAPHICALLY REPRESENTS THE PORTFOLIO. IF HE LOOK AT THE GREEN DOTS AS BEING HIV RESEARCH, YOU CAN SEE IT'S PRIMARILY FOCUSED IN ONE, IT'S HIV FOCUSED, BUT THERE ARE ALSO DISTINCT OVERLAPPING CIRCLES DESIGNATED HIV-RELATED RESEARCH WITH CAPACITY TO INFLUENCE EPIDEMIC WHICH MAY NOT BE ENTIRELY HIV FOCUSED. SO IT BECAME CLEAR THAT THE MOST RELEVANT RESEARCH GOING FORWARD MAY INVOLVE BOTH COMBINED APPROACHES, USING -- INCLUDING HIV AND NON-HIV COMPONENTS. AND WE NEED TO LEVERAGE INVESTMENT TO QUICKLY AND OPTIMALLY ADVANCE HIV RESEARCH. THEREFORE WE QUICKLY MOVED TO THE CONCEPT OF COST SHARING, SO AS TO HAVE THE SCIENCE OF THE PROCESS OF FUNDING. SO AFTER THE PORTFOLIO REVIEW, AND SAME YEAR, 2015, IT WAS A VERY BUSY YEAR FOR US, WE HAD PROPOSED GUIDELINES FOR PRO RATING, AT THE TIME WE CALLED IT PRO RATING, ESSENTIALLY COST SHARING, BASED ON ACCRUED ASSESSMENT OF HIV RELATEDNESS USING CRITERIA SUCH AS PERCENT OF HIV-FOCUSED RESEARCH WITHIN A PROJECT, AND YOU CAN SEE THE FIVE BUCKETS THAT WE ATTEMPTED TO USE THERE. WHEN WE DID A PILOT STUDY USING SUBGROUP OF REVIEWERS FOR THE PORTFOLIO REVIEW IT TURNED OUT THAT THAT INTERPRETATION WAS QUITE VARIABLE AMONG REVIEWERS. IT WASN'T GOING TO MEET OUR NEEDS CLEARLY TO BE ABLE TO CONSISTENTLY APPLY THAT, THIS METRIC. WE HAD TO RETHINK OUR APPROACH TO COST SHARING. WE KNEW WE NEEDED TO DO IT. BUT CLEARLY IN A MORE MEANINGFUL WAY. AND WE NEED TO KNOW HOW WE MIGHT IMPLEMENT SUCH A POLICY. SO IN 2017 OAR ENGAGED A MULTI-DISCIPLINARY GROUP OF EXPERT STAKEHOLDERS TO ADDRESS THE QUESTION AND WE FORMED THE AD HOC COST SHARING TASK FORCE, MEANT TO BE FLEXIBLE AND TIME SENSITIVE AND REPORTING BACK TO THE OAR. TO BE CLEAR, TO BUILD UPON WHAT MAUREEN HAD SLIGHTLY INTRODUCED IN HER TALK, THE COST SHARING TASK FORCE IS ESTABLISHED BY OAR. AND THEY WILL PROVIDE OR HAVE PROVIDED RECOMMENDATIONS DIRECTLY TO US AS PART OF OUR INFORMATION GATHERING PROCESS, TO DEVELOP A POLICY AS I MENTIONED BEFORE. THE MEMBERSHIP ON THE TASK FORCE REFLECT DIVERSE BACKGROUNDS AND EXPERTISE, AND THEY REALLY GAVE US EXPERT THOUGHTFUL RECOMMENDATIONS IN A VERY SHORT TIME FRAME AND REALLY ARE TO BE COMMENDED FOR THAT. SUMMARY OF RECOMMENDATIONS AGAIN WERE ALREADY PRESENTED TO OUR NAEC, FEW COMMENTS, WHICH WAS GOOD, MANY PEOPLE WERE ALSO ON THE EXECUTIVE COMMITTEE. THEN OF COURSE THE RECOMMENDATIONS WILL BE ALSO SHARED WITH NIH LEADERSHIP, AND THEN WE'LL FINALIZE THE POLICY. HERE'S THE PROCESS, LED BY MYSELF AND JUDY AURBACH, CHAIRED BY BRUCE SHACKMAN FROM WEILL CORNELL. BRUCE AND JUDY'S LEADERSHIP, THEY WERE INVALUABLE TO THE PROCESS, REALLY AT ALL THE STAGES. IT WAS A REAL PLEASURE TO WORK WITH THEM ON THIS. AND WE HAD IN ADDITION EXTERNAL MEMBERS, INTERNAL NIH-ERS, REPRESENTATIVES FROM THE TOP SIX INSTITUTES BY ALLOCATION. FOUR MEETINGS, THREE CALLS, ONE IN-PERSON MEETING ON JANUARY 10 IN HERE IN FISHERS LANE. IN ADDITION TO BRUCE, WE HAD GREG CON SAL VEZ FROM, FROM PENN, FROM JUDY KERR FROM UCLA, EXPERT AND INSIGHTFUL COMMENTS FROM THESE BUSY PEOPLE, WE'RE GRATEFUL FOR THEIR TIME AND EFFORT, NIH MEMBERS, THE GOVERNMENT MEMBERS, INCLUDED THE LIST HERE FROM OAR AND I WANT TO SINGLE OUT PETER KIM HERE, BACK AT NIAID AND LAUNCHED THE EFFORT AND WE WANT TO THANK HIM. MOST OF THE NIH MEMBERS ARE ALSO ON OUR EXECUTIVE COMMITTEE, THEIR INPUT WAS CRUCIAL TO THE PROCESS. GUIDING PRINCIPLES, WE WANTED TO USE AIDS-DESIGNATED DOLLARS IN THE MOST EFFECTIVE WAY TO END THE PANDEMIC, IMPROVE HEALTH AND WELL-BEING OF PEOPLE WITH HIV, THAT'S THE OAR VISION. AND WE WANT -- GIVEN THE SCIENTIFIC AND BUDGETARY COMPLEXITIES THAT EXIST AT NIH, IT WOULD REQUIRE OAR AND INSTITUTES HAVE FLEXIBILITY AND PLANNING FOR AND IMPLEMENTING COST SHARING, IN PARTICULAR WE WANTED TO REMIND THEM WE NEED TO IMPLEMENT THIS DURING THE EARLY BUDGET PROCESS, IN A PERSPECTIVE WAY, TO MAKE IT MEANINGFUL REALLY. AND THAT BOTH OAR AND INSTITUTES SHOULD ENSURE TRANSPARENCY AND CONSISTENCY IN ALL STAGES OF THE COST SHARING PLANNING, IMPLEMENTING AND REPORTING. THE FRAMEWORK PROVIDED TO THE TASK FORCE, OR CHARGE, AS IT IS, WAS TWO-FOLD. ONE, HOW DO WE DETERMINE BEST METHOD TO ASCERTAIN PROPORTIONATE OR PERCENT LEVELS OF SUPPORT USING AIDS DESIGNATED INCREASE DOLLARS WHEN AN AREA IS NOT SOLELY FOCUSED ON HIV. AND KEEPING IN MIND THAT IT'S CRITICAL TO DEVELOP MECHANISMS THAT CAN BE APPLIED PROSPECTIVELY AS I JUST SAID AND TOPICAL BASIS, NOT JUST GRANT BY GRANT BASIS BUT AREA OF SCIENCE. TASK FORCE PROVIDED RECOMMENDATIONS TO THE OAR, AND I'LL DESCRIBE A FEW HIGHLIGHTS. BUT IN THE AREA OF IMPLEMENTATION THEY RECOMMENDED WE IDENTIFY TOPICAL GROUPINGS THAT COULD BE APPLIED ACROSS ALL THE INSTITUTES, CENTERS AND OFFICES, AND FUNDING MECHANISMS. WHICH IS STRAIGHTFORWARD, I THINK, THAT THEY ALSO RECOMMENDED THAT WE TOGETHER DETERMINE LEVEL OF COST SHARING, IN AN AREA OF SCIENCE, AND DO IT AGAIN PROSPECTIVELY, THEY AGREED WITH OUR GUIDELINES THIS WOULD BE THE BEST WAY TO IMPLEMENT THIS. AND THEY WANTED US TO LOOK AT THE DEFINITIONS AND PERCENTAGE OR LEVELS THESE TOPICAL GROUPINGS PERIODICALLY, TO KEEP UP WITH CHANGING SCIENCE. AND CRITERIA IS THE MOST IMPORTANT SLIDE IN THE WHOLE PRESENTATION, IF YOU TAKE ONE TAKEAWAY SLIDE, THIS WOULD BE IT, BECAUSE THIS IS WHAT WE GRAPPLED WITH IN THE PAST WITH HOW TO DETERMINE PROPORTIONATE LEVELS, AND WE HAD A DIFFICULT TIME IN THE PAST TO DETERMINE THAT. THE FIRST REALLY TWO IMPORTANT POINTS IS TAKE INTO ACCOUNT INCIDENCE AND PREVALENCE OF A CONDITION IN POPULATIONS LIVING WITH LIVE AND ELEVATED RISK FOR HIV INFECTION. AND/OR THE TRANSLATIONAL POTENTIAL OF THE SCIENCE. SECONDLY, THE COST SHARING LEVELS SHOULD BE DETERMINED IN ACCORDANCE WITH PROPOSED CRITERIA FOR HIV RELATEDNESS, AND THAT BASICALLY IS STATED IN THE 2015 NOTICE FOR ALIGNMENT. SCIENTIFIC PRIORITIES IN THE STRATEGIC PLAN. OAR STRATEGIC PLAN INFORMS INITIATIVE DEVELOPMENT BY INSTITUTES, INSTITUTES BRING IN INITIATIVES TO OAR FOR REVIEW AND DETERMINATION THERE OF POTENTIAL COST SHARING ARRANGEMENTS. OKAY. SO I WILL BE AS BOLD IN THE NEXT FEW SLIDES TO GIVE YOU EXAMPLES OF AREAS THAT WERE SUGGESTED FOR APPROPRIATE COST SHARING. AGAIN, THIS IS NOT AN INCLUSIVE LIST. REALLY, THESE ARE JUST SUGGESTIONS THAT ARE MEANT AS A GUIDE FOR THE INSTITUTES AND OAR. IT'S NOT MEANT TO LIST EVERY RELEVANT AREA OF SCIENCE OR TOPIC. BUT IN GENERAL I WANTED TO DEFINE WHAT WE MEAN BY HIV RELATED AND RELEVANT SCIENCE, DEFINED AS AN ACTIVITY IN WHICH HIV OR AIDS IS A MEANINGFUL COMPONENT OF THE ACTIVITY, AND/OR THE KNOWLEDGE ABOUT HIV WILL BE ENHANCED. AND ALSO THAT HIV IS ONE OF MULTIPLE COMPONENTS OR PART OF A BROADER SAMPLE OR COMPARATIVE COHORT WHERE HIV IS NOT THE PRIMARY FOCUS. SO, FOR EXAMPLE, THE FIRST TWO LISTED HERE BASIC RESEARCH ON PATHOGENS, CANCERS, VIRUSES, ONCOGENIC VIRUSES, THAT AFFECT HIV-INFECTED PEOPLE, INCREASED SUSCEPTIBILITY OR BENEFIT PERSONS, COVERING TB, MALARIA, AND MANY OTHERS. CLINICAL TRIALS AND COHORT STUDIES OF COMORBIDITY COULD BE CARDIOVASCULAR RESEARCH, CHRONIC INFLAMMATION, ASSOCIATED NEUROCOGNITIVE DISORDERS, HIV-ASSOCIATED MALIGNANCIES, AND EXPOSED UNINFECTED CHILDREN. MORE EXAMPLES WOULD INCLUDE CLINICAL TRANSLATIONAL AND INTERVENTIONAL RESEARCH ON COMORBIDITIES WHICH THE FOCUS IS ON COMORBIDITES BUT HIV IS INCLUDED, AND THIS MIGHT BE CLINICAL TRIALS WITH TREATMENT AMONG PEOPLE WHO USE DRUGS, PEOPLE LIVING WITH ELEVATED RISK OF ACQUIRING HIV INFECTION. THE BASIC CLINICAL TRANSLATIONAL RESEARCH ON HIV HEALTH PROMOTION AND TREATMENT IN THE CONTEXT OF HEALTH SYSTEMS, EXAMINING FACILITIES, OBSTACLES, ACCESS TO AND UPTAKE OF PREVENTION AND TREATMENT SERVICE AMONG THOSE AT RISK. AND THEN BASIC SOCIAL SCIENCE RESEARCH ON FACTORS OR SOCIAL DETERMINANTS, INCLUDING TRANSMISSION, ACQUISITION OF SEXUALLY TRANSMITTED INFECTION INCLUDING BUT NOT FOCUSED ON HIV. EXAMPLE WOULD BE STUDIES ASSESSING ROLE OF GENDER BASED VIOLENCE, STI ACQUISITION AMONG ADOLESCENT GIRLS AND YOUNG WOMEN. AND LASTLY EXAMPLES ARE SOME BASIC IMMUNOLOGY RESEARCH WHICH WOULD HAVE APPLICABILITY TO TRANSLATIONAL RESEARCH THAT INFORMS FUNDAMENTAL MECHANISMS RELEVANT TO HIV DISEASE, AND NOT FOCUSED ON ANOTHER CLINICALLY RELEVANT PATHOGEN INCLUDING INNATE, B AND T CELL, ADJUVANTS, IMAGING A TECHNOLOGIES, BIOINFORMATICS, COMPUTER MODELING RELATED TO IMMUNE MONITORING OR MONITORING OF IMMUNE FUNCTION, OR IMMUNOTHERAPEUTICS RELATIVE TO HIV-INFECTED TREATMENT. AGAIN, THIS IS NOT INCLUSIVE, JUST A FEW EXAMPLES FOR YOUR INFORMATION. SO THE TASK FORCE RECOMMENDED OAR GOING FORWARD THAT, AGAIN, TRANSPARENCY IS RECOMMENDED, ACROSS THE INSTITUTES, ALSO WITHIN THE COMMUNITY, ON THE TOPICAL GROUPINGS THAT WE SELECTED TO COST SHARE WITH AS WELL AS LEVELS. AND CLEARLY PERSPECTIVE PLANNING IS KEY HERE BECAUSE IF WE DO THIS AT THE OUTSET, IT GIVES US A LOT MORE FLEXIBILITY THAN TO BE ABLE TO MEANINGFULLY AGREE UPON THIS PROCESS, AND IMPLEMENT IT DOWN THE LINE. OAR IS ENCOURAGED TO CONSIDER APPLYING RECOMMENDATIONS TO INTRAMURAL ACTIVITIES AS WELL, SO REALLY THE TASK FORCE INFORMED US EXPERTLY AS TO OUR NEXT STEPS, WHICH AT THIS POINT IS TO FINALIZE, AGAIN INPUT FROM STAKEHOLDERS, AND WITH NIH LEADERSHIP FINALIZE POLICY ON COST SHARING AND IMPLEMENT IT SO I THINK THAT'S IT. THANKS FOR YOUR ATTENTION. IF YOU HAVE ANY QUESTIONS, YOU CAN ASK BRUCE. HE'S SITTING RIGHT BACK THERE. [LAUGHTER] >> OKAY. OPEN FOR DISCUSSION. ANYONE, PLEASE. >> I JUST WANT YOU TO SAY MORE ABOUT THE TOPICAL GROUPING IDEA AS OPPOSED TO GRANT BY GRANT AND WHAT THAT WOULD MEAN IN PRACTICE. >> YEAH, SO IT'S EASIER FOR US I THINK TO IDENTIFY AN AREA OF SCIENCE THAT WOULD BE RELEVANT HERE THAN JUST GOING DOWN AND DRILLING DOWN INTO IT, BECAUSE AT THE PERSPECTIVE STAGE OF FUNDING WE ACTUALLY DON'T HAVE THE GRANTS YET. YOU KNOW, IT'S AN INITIATIVE STAGE. AT THAT LEVEL WE CAN THEN SORT OF COME UP WITH AN AGREEMENT ABOUT AN AREA THAT WE NEED TO HIGHLIGHT AND THEREFORE FUND. YEAH, WE CAN'T DO IT AFTER THE FACT. IT'S MUCH MORE DIFFICULT. >> BRUCE? >> THANKS, JEAN. FIRST ON BEHALF OF THE TASK FORCE, I WANT TO THANK JEAN AND JUDY AURBACH WHO DID A FANTASTIC JOB GUIDING US ALONG THE PATH. TO FOLLOW INGRID'S QUESTION, WE GOT SPECIFIC GUIDANCE THE PREVIOUS ATTEMPT ON GRANT BY GRANT BASIS WAS NOT FEASIBLE GIVEN STAFF AND ALSO GIVING INCONSISTENT READS. SO WE WERE SORT OF ASKED TO THINK ABOUT A MORE PROSPECTIVE STRUCTURE. AND SO, WHAT WE TRIED TO DO IS PROVIDE RECOMMENDATIONS THAT ARE NOT DEPENDENT ON THE CURRENT SET OF PRIORITIES BY THE DIRECTOR, BECAUSE THOSE ARE GOING TO CHANGE AS THE EPIDEMIC CHANGES, AS SCIENCE CHANGES, AS THE DIRECTOR CHANGES HIS PERCEPTION OF THOSE THINGS AS WELL, HIS OR HER PERCEPTION OF THOSE THINGS AS WELL. SO WHAT WE TRIED TO DO IS CREATE SOME GUIDANCE THAT WOULD BE REGARDING A PROCESS THAT COULD ACCOMMODATE THOSE CHANGES OVER TIME. AND MANY OF THESE AREAS OF OPPORTUNITY FOR COST SHARING FALL MORE WITHIN MEDIUM PRIORITY LEVEL RATHER THAN HIGH, PART IS TO HIGHLIGHT THAT OPPORTUNITY FOR THINGS THAT MAY NOT BE AT THE TOP OF THE HIV PRIORITY LEVEL AND COMPLETELY 100% HIV RELATED. SO I THINK OF THIS AS THE PROCESS THAT WILL OPEN THE DOOR FOR ICs TO CONSIDER BUT IT'S UP TO THE ICs TO STEP THROUGH THE DOOR. WE REALLY HOPE WE REALIZE FUNDS ARE LIMITED AND THERE ARE PRIORITIES THAT HAVE TO BE SET, BUT WE HOPE THAT THIS WILL GIVE FLEXIBILITY TO THE ICs TO THINK ABOUT WORKING IN MORE CREATIVE WAYS IN TERMS OF FUNDING, TAKING ADVANTAGE OF THESE OPPORTUNITIES BUT AGAIN IT'S GOING TO BE UP TO THE ICs TO DO THAT. AND I HOPE THAT IN THE FUTURE WE'LL GET A REPORT BACK AS TO HOW THEY HAVE -- HOW MUCH THEY WALKED THROUGH THE DOOR AND TO WHAT DEGREE. >> CARL? >> ONE OF THE INSTITUTES WE REALLY WELCOME THIS, WHEN THE EVENT OCCURRED WITH NOTICE IN THE GUIDE FRANCIS PUBLISHED IN 2015 PUT A CHILL ON CERTAIN TYPES OF RESEARCH, MADE IT DIFFICULT TO SUPPORT, AN EXAMPLE FROM TB WE COULD DO ANYTHING WE WANTED CLINICALLY WITH TB, IN HIV-INFECTED PEOPLE, BUT IN ORDER TO GET AN INTERESTING MOLECULE THAT MAY HAVE SOME VERY SPECIFIC ACTIVITY, WHETHER IT'S A VACCINE OR DRUG, THROUGH THE PIPELINE, WE COULDN'T USE HIV MONEY. SO IT REALLY CREATED AN IMBALANCE. AND WHAT THIS DOES IS RECTIFY THIS NOT JUST FOR TB AND IMMUNOLOGY BUT ACROSS THE INSTITUTES AS YOU'RE SAYING FOR THE MEDIUM PRIORITIES, CARDIOVASCULAR DISEASE, THE LIST OF CANCER-CAUSING VIRUSES IS A PERFECT EXAMPLE. SO THIS IS IN MANY WAYS PUTTING A STRUCTURE AROUND WHAT IS PART OF THE EVOLUTION THAT IS NEEDED IN ORDER FOR HIV RESEARCH TO REALLY BREAK THROUGH SOME OF THESE ONGOING WHAT HAVE BECOME UNFORTUNATELY STRUCTURAL BARRIERS THAT ARE THEN IMPEDING SCIENTIFIC PROGRESS, IT WILL MAKE A BIG DIFFERENCE. >> I MIGHT ALSO ADD IN ADDITION TO TAKING ADVANTAGE OF THE AREAS OF SCIENCE THAT WE SHOULD BE INVESTING IN, THERE ARE INSTITUTES THAT ARE CURRENTLY COST SHARING, AND UNFORTUNATELY THEY ARE DOING IT VERY DIFFERENTLY AMONG INSTITUTES. SO WE WANT TO BE ABLE TO GET A HANDLE AND BE ABLE TO APPLY THIS IN A VERY CONSISTENT WAY. >> I HAD A QUESTION WHICH IS IT SEEMS LIKE THE DIRECTION IS HIV DOLLARS TOWARDS OTHER TOPICS THAT ARE HIV RELATED AND WOULD ADD. SO THAT'S THE QUESTION. LIKE IF I. >> BIDIRECTIONAL. >> BY DIRECTION -- BIDIRECTIONAL. >> IT'S AN EQUILIBRIUM. ANY OTHER -- PLEASE, LINDA. >> SO, I GUESS IT'S ENCOURAGING IN RECENT YEARS THE DIFFERENT INSTITUTES COLLABORATING ON HIV-RELATED THINGS, AND I HEARD WHAT CARL SAID, I'M WONDERING WITHOUT NAMING ANY NAMES OF OTHER INSTITUTES, WHAT DO YOU FEEL LIKE WAS -- IS THERE BUY-IN HERE FROM OTHER INSTITUTES? I SAW THE SLIDE GO BY QUICKLY OF OTHER INSTITUTES INVOLVED IN YOUR PROCESS. I JUST WONDER -- >> WE DID BRING IN TO OUR AIDS EXECUTIVE COUNCIL INCLUDING MEMBERSHIP FROM MOST OF THE INSTITUTES WHO FUND HIV RESEARCH, OF COURSE WE HAD SIX MEMBERS OF INSTITUTES, SIX INSTITUTES ON OUR TASK FORCE. I THINK, YOU KNOW, THERE MIGHT HAVE BEEN SOME HESITATION AT FIRST, I THINK THAT MOST PEOPLE FEEL LIKE CAUTIOUSLY OPTIMISTIC THAT THIS MIGHT BE SOMETHING THAT, YOU KNOW, IT'S HARD TO GRAPPLE WITH CHANGES, THE PREVIOUS SPEAKER WAS SAYING, ADAPTING TO THAT, BUT I THINK THAT, YOU KNOW, IF WE CAREFULLY PLAN IT THERE COULD BE OPPORTUNITIES HERE THAT WE HAVE NOT TAPPED INTO YET. WE'LL SEE. IMPLEMENTING IS GOING TO BE HARD. NIH SYSTEM IS CUMBERSOME BUT I BELIEVE WE CAN DO IT. >> THIS GROUP, LIZ, OKAY, THERE WILL BE A PROCESS BY WHICH THIS GROUP WILL LOOK AT POLICY DOCUMENT. THAT'S ACTUALLY -- THAT WAS THE TIME FOR COUNCIL DISCUSSION. DOES THAT MEAN THAT WE WILL BREAK FOR LUNCH MAYBE FIVE MINUTES EARLY? WHICH I THINK IS OKAY UNLESS PEOPLE ARE SAD ABOUT THAT. OKAY. ALL RIGHT. WE'RE OKAY WITH IT. SO WE WILL BE BACK HERE AT 1:00. AND IN WHICH CASE WE'LL HEAR THE UPDATE FROM DR. BROWN ON THE TRANS-NIH STRATEGIC PLAN. THANK YOU. THE EAR SESSION THIS MORNING WE HEARD AN UPDATE FROM THE DIRECTOR FROM OARAC AND HEARD ABOUT TERMS THAT ARE SENDING IN THIS GROUP. THE NEW VOTING MEMBERS THAT ARE JOINING AND THEN WE HEARD ABOUT THE NEW AD HOC MEMBERS WE HEARD ABOUT THE NOW THREE IN-PERSON ANNUAL MEETING GOING FORWARD. NEW KEY APPOINTMENTS AT THE VERY HIGH LEVELS OF SECRETARY OF HHS AND DIRECTOR OF THE CDC AND THEN WE HEARD SOME CHANGES IN THE OAR STAFF MOVING ON. THEN WE HEARD ABOUT DIRECTOR ACTIVITIES OVER THE LAST SIX MONTHS. THEN WE HEARD FROM THE DHHS GUIDELINES COMMITTEES ALL THREE AND APPROVED THOSE PRESENTATIONS THEN FINALLY WE HEARD ABOUT THE RESTRUCTURE OF THE AIDS STUDY SECTION GROUPS AND HOW DIFFERENT THAT'S WILLING GO TO BE AND IT'S GOING TO GO INTO SIX, WE HEARD ABOUT THE ACRONYMS FOR THOSE AND THEY MAY CHANGE AND HOW THAT WILL GO INTO PLAY IN SEPTEMBER 2018 FOR THAT CYCLE. WE ALL WILL HAVE OPPORTUNITY TO COMMENT ON DESCRIPTIONS OF THOSE STUDY SECTIONS STARTING IN MAY. FOR DIRECTIONAL FLOW OF FUNDS FROM RELATED MUNICIPALS AND BACK AND FORTH FROM THE INSTITUTES TO FUND THE MOST IMPORTANT SCIENCE THAT'S RELEVANT TO HIV. SO, NOW WE'RE AFTER THE BREAK WE'RE GING TO HEAR FROM DR. GINA BROWN ABOUT THE TRANS-NIH STRATEGIC PLAN FOR HIV AND HIV-RELATED RESEARCH. PRESENTATION OF THESE PRIORITIES AHEAD OF THE BUDGET GINA WILL TALK ABOUT THAT. GINA BROWN JOINED IN 2008, CURRENTLY LEADING REALLY THE NON-VACCINE PREVENTION INITIATIVES WITHIN REDUCING INCIDENT SECTION ALSO SERVES AS LEAD FOR RESEARCH PRIORITY AREA OF COMORBIDITIES, COINFECTIONS, BIG PROPONENT OF WOMEN'S REALLOT RESEARCH SO THANK YOU. >> THANK YOU, EVERYBODY. WHAT I'M GOING TO TALK YOU THROUGH WHAT WE'VE BEEN DOING WITH PUTTING TOGETHER THE TRANS-NIH PLAN FOR HIV RELATED RESEARCH FOR FY19-20 WHICH YOU'LL GET HOW WE'RE GOING ABOUT THIS HOW WE'RE GATHERING EXTERNAL INFORMATION WHAT WE EXPECT TO END UP WITH AS A PRODUCT AT THE END. THE VISION OF OAR IS DO -- FACILITATE RESEARCH THAT WILL BRING AN END TO THE PANDEMIC AND IMPROVE THE HEALTH OF PEOPLE WITH HIV. WE IMPLEMENT THAT THROUGH ACTIVITIES, ONE BY COMMUNICATION BIDIRECTIONAL COMMUNICATION WITH THE OFF OF AIDS RESEARCH WITH THE TRANS-NIH RESEARH PROGRAM. ALSO WITH EXTERNAL STAKEHOLDERS. WE ALSO CATALYZE, CONVENE AND COORDINATE TRANS-NIH RESEARCH MAKING SURE THAT WE REALLY ADDRESS THE HIGHEST PRIORITY ITEMS BUT ALSO ENSURING THAT THERE'S NOT UNNECESSARY DUPLICATION OF EFFORT. THE GOAL IS TO REALLY PRIORITIZE THE PROGRAMS AND RESEARCH THAT WILL LEAD US TOWARD REACHING THE ULTIMATE ACCOMPLISHING THE VISION OF THE OFFICE OF AIDS RESEARCH. WE ARE REQUIRED TO PUT TOGETHER STRATEGIC PLAN THAT COORDINATES HIV RESEARCH THROUGH THE NIH. THE GOAL OF THAT TO REALLY ADDRESS THE GAPS BUT LOOK AT THE OPPORTUNITIES THAT ARE AVAILABLE BOTH FROM PREVIOUS ACCOMPLISH MENTS BUT ALSO AS SCIENCE MOVES ALONG HOW DO WE PUSH THE SCIENCE FORWARD. ABSOLUTELY SUPPORT THE COORDINATION OF EFFORTS WE DON'T HAVE LOT OF PEOPLE TRYING TO DO THE SAME THING LEAVING GAPS WHERE SOMETHING ELSE COULD BE DONE. AND TO MAKE SURE THAT WE BEST USE THE NIH RESOURCES TO ACCOMPLISH THE RESEARCH. PROVIDE BOTH STRUCTURE AND GUIDANCE FOR RESEARCH COLLABORATION AND WHEN YOU LISTEN TO OVER THE COURSE OF THE YEARS LISTEN TO THE DIFFERENT INSTITUTES AND CENTERS TALK ABOUT THE WORK THAT THEY'RE DOING. HEAR SOME OF THESE EFFORTS TO COORDINATE RESEARCH BETWEEN AND AMONGST THE DIFFERENCE INSTITUTES. OTHER THING THIS DOES BY PROVIDING TRANS-NIH PLANS IT PROVIDES THE BLUEPRINT WHICH THE BUDGETING HIV RESEARCH AND ALSO HOW FUNDING DECISIONS ULTIMATELY ARE MADE TO ENSURE THAT THEY CORRESPOND TO THE HIGHEST PRIORITY RESEARCH. WHAT YOU'RE GOING TO HEAR ABOUT IS THE FY19-20 STRATEGIC PLAN IN PREVIOUS YEARS WE'VE DONE INDIVIDUAL PLANS FOR EACH YEAR. THIS WILL BRING US TO A POINT WHERE WHEN OUR PLANNING PROCESSES WILL ACTUALY BE COINCIDING WITH HAVING TRANS-NIH PLAN OUT AHEAD OF MOST OF THE IC s AND THEIR PLANNING PROCESSES IT WILL HELP GOOD WHAT RESEARCH GETS FUNDED IN THE FUTURE. AS OF FY2021 WE'LL PROVIDE TRANS-NIH PLAN THAT ENCOMPASSES THREE YEARS OF RESEARCH, WE'RE REQUIRED TO ANNUALLY REVIEW THAT RESEARCH PLAN THEN PROVIDE SOME UPDATES BUT ACTUAL COMPREHENSIVE PLAN MOVING FORWARD WILL HAPPEN IN ABOUT THREE-YEAR CYCLES, ADDRESSING, REVIEWING ALLOWS US TO BE NIMBLE AS RESEARCH CHANGES SOMETIMES VARY QUICKLY. BUT ALSO RECOGNIZING THAT YOU HAVE TO PLAN OUT BECAUSE PROJECTS TAKE MUCH LONGER THAN A SINGLE YEAR'S WORTH. THE ANNUAL BUDGET PLANNING WILL STAY BASICALLY THE SAME. AN ANNUAL EFFORT AS YOU'VE SEEN IF YOU WATCH THE NEWS. THEN WE'LL USE THIS ANNUAL REVIEW OF THE STRATEGIC PLAN TO REALLY ADDRESS WHATEVER GAPS ARISE AS RESULT OF SOME OF THE RESEARCH THAT'S OCCURRED OR AS WE LOOK UP SEE SOMETHING LIKE THE NEW INFECTIOUS ISSUES SURROUNDING THE OPIOID EPIDEMIC BEING ABLE TO RESPOND IN A NIMBLE PHYSICIAN. ENSURE THAT THERE IS A BUDGET THAT CAN ADDRESS THAT. IN THE DEVELOPMENT OF THE PLAN WE'RE TRYING TO MAKE SURE THAT WE ENHANCE TRANSPARENCY. EVERYBODY KNOWS WHAT THE PROCESSES ARE, EVERYBODY KNOWS WHAT THE APPROACHES ARE THAT THERE ARE OPPORTUNITIES FOR INDIVIDUAL STAKEHOLDERS AND GROUP STAKEHOLDERS INSIDE AND OUTSIDE OF NIH TO BE ABLE TO WEIGH IN. SET UP NUMBER OF PROCESSES TO MAXIMIZE STAKEHOLDER INPUT BUT IN ADDITION WE'LL USE DATA TO IDENTIFY WHAT THE SCREENTIVE I CAN PRIORITIES SHOULD BE. YOU'VE HEARD ABOUT PORTFOLIO REVIEW OVER THE PREVIOUS MEET INGS. THERE'S A DATA ANALYTICS TEAM THAT YOU'LL HEAR MUCH MORE ABOUT THAT GETS A SENSE OF HOW MUCH IS ACTUALLY BEING SPENT ON DIFFERENT RESEARCH AREAS, WHAT'S ALREADY BEEN ACCOMPLISHED AND THAT LET'S US BETTER ASSESS WHAT THE GOALS ARE. THEN OAR STAFF ARE USED TO PROVIDE THAT TRANS-NIH PERSPECTIVE. PROVIDE A PLATFORM FOR COLLABORATION. THIS IS THE TIMELINE, WE HAD AN RFI, REQUEST FOR INFORMATION THAT WENT OUT IN 201 WE GOT RESPONSES BACK. WE HAVE AIDS EXECUTIVE COMMITTEE THAT'S MADE UP OF REPRESENTATIVES FROM EACH OF THE DIFFERENT UPS TAKE TOUTS AND CENTERS THAT RECEIVE HIV FUNDING THAT IS THE NAAC THE NIH AIDS EXECUTIVE COMMITTEE THEY PROVIDE INPUT IN FEBRUARY. WE HAVE SMALLER WORKING GROUP OF THAT, THAT AIDS EXECUTIVE COMMITTEE THAT ARE REALLY HELP ING US FOCUS THIS, I'LL WALK THROUGH THAT IN A SECOND. I PROVIDED THIS SAME PRESENTATION TO THE NAC THAT I'VE GIVING TO YOU TODAY THEY HAD CHANCE TO WEIGH IN AND ASK QUESTIONS. WE HOPE TO HAVE FINAL DRAFT BY END OF THE APRIL AND IT WILL GO FOR CLEARANCE, BUILDING ONE IS THE OFFICE OF THE DIRECTOR OF NIH DIRECTOR IT SHOULD BE GOING TO THE OFFICE OF THE DIRECTOR BY MAY OF 018. THERE WILL BE ANOTHER ONE COMING OUT TO INFORM THE 20 1 PLAN, THEY ARE STRUCTURED QUESTIONS, WE GET ANSWERS AND OTHER INPUT. THE NAEC LOOKED AT PREVIOUS ITERATION OF THE PLAN PROVIDED INPUT ON THAT AND EDITS BUT IN ADDITION THEY GAVE US LIST OF WHAT THEY THOUGHT THE GAPS WERE IN RESEARCH. ALSO TOLD US ABOUT THE ACCOMPLISHMENTS, AREAS THAT ARE COVERED THROUGH THEIR INSTITUTE AND CENTER, FROM THAT WE CAN GET SENSE OF WHAT ARE THE OPPORTUNTIES THAT ARE AVAILABLE TO FURTHER RESEARCH. IN ADDITION THEY ALSO PROVIDED US WITH A LIST OF THEIR FUNDING OPPORTUNITY ANNOUNCEMENTS THAT GIVES US MUCH BETTER SENSE OF WHAT'S ALREADY BEING PLANNED SO WE DON'T STRUCTURE THE TRANS-NIH PLAN BUT THINK ABOUT THIS IN TERMS OF MOVING THINGS FORWARD. SMALLER WORKING GROUP AS WORKED WITH US TO PRIORITIZE WITHIN FOUR AND CROSS CUTTING OVERARCH ING PRIORITIES. WE'RE WORKING WITH THAT NOW, THEIR IN PUT ALSO THE INPUT FROM THE NAEC AND RFI TO COME UP WITH A COMPREHENSIVE PLAN. THEN O.A.R. STAFF WILL REVIEW AND EDIT THAT. THE RFI RESPONSE WAS PRETTY TREMENDOUS THERE ARE 318 RESPONSES, THERE WAS DEPTH AND BREADTH OF THE KIND OF RESPONSES THEY PRETTY MUCH REFLECT THE STAKEHOLDERS ACADEMIC INSTITUTIONS WHERE 60% OF THE RESPONSES BY PARTNERSHIPS AND NETWORKS ARE GROUPS OF INDIVIDUALS WHO CAME TOGETHER OR GROUPS OF ORGANIZATIONS THAT CAME TOGETHER TO PROVIDE INPUT AT ABOUT 13.5% OF THE RESPONSES. THERE WERE INDIVIDUALS, ADVOCACY ORGANIZATIONS, COMMUNITY-BUYSED ORGANIZATIONS, BUT YOU CAN SEE HOW IT BREAKS DOWN. AS I SAID TRYING TO SUMMARIZE THIS INTO A SINGLE SLIDE, REALLY COMPLETELY DOES NOT DO IT JUSTICE BUT THESE ARE JUST SOME OF THE BROAD AREAS. THINGS THAT STAND OUT, THOUGH, I THINK SHOULD BE PAID ATTENTION TO ARE THEY STRESS THE IMPORTANCE OF GLOBAL RESEARCH AND GLOBAL PARTNERSHIPS. ALSO TRANS-NIH, TRANS GOVERNMENTAL, EXTRAMURAL, COMMUNITY AND GLOBAL COLLABORATIONS THAT NEED TO HAPPEN TO MAKE SURE THAT RESEARCH IS ACCOMPLISHED IN AN EFFICIENT AND EFFECTIVE MANNER. THERE IS ABSOLUTELY A LOT OF DISCUSSION AROUND BSSR AND STIGMA-RELATED RESEARCH THEN MANY GROUPS THOUGHT IT WAS ABSOLUTELY IMPORTANT THAT WE THINK VERY HARD ABOUT HOW WE'RE GOING TO STRUCTURE AND BUILD IN BRINGING ALONG THIS NEXT GENERATION. THERE'S BEEN TREMENDOUS SUPPORT FOR LOOKING AT RESEARCH ACROSS THE LIFE CYCLE NOT JUST INFANTS, NOT JUST PREGNANCY, NOT JUST OLD AGE BUT RECOGNIZING IF YOU'RE GOING TO UNDERSTAND THOSE DIFFERENCES YOU ALSO NEED TO UNDERSTAND WHAT'S HAPPENING IN YOUNGER CHILDREN, WHAT'S HAPPEN ING IN ADOLESCENTS, WHAT'S HAPPENING IN YOUNGER AND OLDER ADULTS SO THAT OUR RESEARCH WILL ENCOMPASS THAT. LOOKING AT HEALTH DISPARITIES. AS I SAID THE NAEC INPUT IS TO PROVIDE US WITH MUCH GREATER SPECIFICITY. WHAT WE'RE NOT TRYING TO DO IS GIVE YOU A LAUNDRY LIST OF EACH INDIVIDUAL KIND OF STUDY. WHAT WE'RE WORKING ON IS COMPREHENSIVE LANGUAGE THAT LEAVES ROOM FOR DEPTH AND BREADTH OF STUDIES THAT NEED TO HAPPEN BUT ALSO TRYING TO BE MORE SPECIFIC WITHIN THE CONTEXT OF OUR OVERARCHING PRIORITIES. WE'RE DEFINING THE GAPS, I THINK LOOKING AT WHAT ARE THE INFRASTRUCTURE NEEDS THAT NEED TO BE BUILT IN AND SUPPORTED OVER TIME TO ENSURE THAT THIS RESEARCH CAN CONTINUE TO OCCUR. MOST IMPORTANTLY LEVERAGING THE OPPORTUNITIES. WHAT'S THE RESEARCH THAT NEEDS TO BE DONE IN RESPONSE TO THE SUCCESSES OR SOME OF WHAT WE CALL FAILURES OR -- THAT I THINK ARE BETTER CLASSIFIED AS LEARN ING EXPERIENCES ALONG THE WAY. MAKING SURE THAT WE GET -- WE'RE MAKING SURE THAT WE GET INPUT FROM ANYBODY WHO HAS HIV BUDGET FROM WITHIN NIH, REAL GOAL IS ALSO TO SUPPORT COLLABORATION. WE CAN BE BOTH COST EFFICIENT BUT ALSO SUPPORTS MULTI- DISCIPLINARY SCIENCE THAT PROBABLY IS THE REAL ANSWER TO HOW WE'LL GET TO THE END OF THIS PANDEMIC. ADDRESS THE DIFFERENT TOPICS KNOW HOW MONEY IS BEING SPENT EVEN IF IT MAY -- THERE MAY BE SOMETHING IN A DIFFERENT INSTITUTE THAT DOESN'T LOOK LIKE IT OUGHT TO BE ASSOCIATED WITH THAT INSTITUTE BUT ACTUALLY COVERS THE TOPIC AND LOOKING FOR OPPORTUNITIES FOR THE INSTITUTES AND CENTERS TO WORK TOGETHER FOR LARGER -- GREATER GOOD. WHEN YOU LOOK AT THIS PLAN YOU'RE NOT GOING TO SEE INIVIDUAL DO RESEARCH ON THIS IN WOMEN, DO RESEARCH ON CHILDREN, BUT PROVIDE SOME COMPREHENSIVE LANGUAGE THAT RECOGNIZES THAT THIS NEEDS TO BE DONE ACROSS AGE GROUPS, ACROSS MOST AT-RISK POPULATIONS WITHOUT NECESSARILY CALLING THEM OUT FOR EVERY SPECIFIC THING. LOOKING AT DISEASES AS AS WHOLE NOT NECESSARILY CALLING OUT EACH AND EVERY INDIVIDUAL DISEASE THAT NEEDS TO BE COVERED. IT'S LANGUAGE THAT WILL LET YOU KNOW IT CAN BE ENCOMPASSED BUT DOESN'T MEAN THAT THERE'S A LAUNDRY LIST AND CHECKLIST YOU SAY, CARDIOVASCULAR, WE CAN'T DO BONE. IT ALLOWS SOME NIMBLENESS WITH RESPECT TO OUR UNDERSTANDING. LONGER PERIOD OF TIME IN OTHERS. THEN BREAK DOWN BY INDIVIDUAL RESEARCH PRIORITIES. WITHIN THAT WE'LL GO TO EACH OVERARCHING PRIORITY, PROVIDE SUMMARY STATEMENT ABOUT THE OBJECTIVES AND RESEARCH GAPS AND THEN WHAT THE PRIORITIZED RESEARCH OPPORTUNITIES, PARTICULARLY BASED ON THE INPUT FROM THE NAEC SMALLER WORKING GROUP BUT ALSO INCLUDING THE CORRECTIONS OR EDITS TO THE PLAN PROVIDED BY GREATER NAEC AND RFI FUNDAMENTAL CROSS CUTTING RESEARCH, EXAMPLE I CAN GIVE IS THERE'S BEHAVIORAL AND SOCIAL SCIENCES RESEARCH THAT'S APPLICABLE TO LOOKING AT REDUCING THE INCIDENTS BUT THERE'S ALSO FUNDAMENTAL BEHAVIORAL AND SOCIAL SCIENCES RESEARCH THAT INFORMS HIV/AIDS IN GENERAL, HIV/AIDS RESEARCH IN GENERAL THAT ISN'T NECESSARILY CLASSIFIED AS ONLY WITH CO MORBIDITIES OR ONLY WITH REDUCING THE INCIDENTS OR ONLY WITH CURES. PROVIDES US THAT OPPORTUNITY FOR THIS CROSS CUTTING RESEARCH TO BE DONE ON LARGER LEVEL. THEN WE'LL ALSO OUTLINE SPECIFIC GAPS AND OPPORTUNITIES AND PRIORITIES FOR EACH OF THE CROSS CUTTING AREAS IN SOMEWHAT SHORTER VERSION. WHAT WE HOPE TO END UP WITH IS PLAN THAT REALLY ENCOMPASSES THE INPUT FROM RFI FROM THE O.A.R., RFI GIVES US OUR OUTSIDE OF NIH INPUT THAT IS ABSOLUTELY IMPORTANT. OTHER THAN THE SMALLER MEETINGS HE WE USED TO HAVE WITH EXTERNAL REPRESENTATIVES IT DOES PROVIDE THE OPPORTUNITY FOR ANYBODY WHO WANTS TO WEIGH IN, WHO EXPANDS OUR ACCESS TO THE VARIETY OF STAKEHOLDERS WHO HAVE AN INTEREST IN HIV/AIDS AND HIV/AIDS RESEARCH. WE ULTIMATELY HOPE TO END UP WITH PLAN THAT BOTH INFORMS THE BUDGET AS NECESSARY. REALLY INFORMS WHAT THE ULTIMATE NIH RESEARCH PORTFOLIO IS BUT ALSO GIVES US THE RESEARCH WITH THE GREATEST RELEVANCE TO ULTIMATELY END THE PANDEMIC AND IMPROVE THE LIFE OF PEOPLE WITH HIV. HI DO HELP IN TERMS OF US FULLY UNDERSTANDING WHAT WE CAN AND CAN'T DO WITH THIS. >> THIS IS OUR TIME FOR DISCUSSION. IT SEEMS LIKE THIS IS BEING DONE ENOUGH IN ADVANCE THAT IT WILL INFORM THE BUDGET LIKE YOU SAID IF WE LOOK BACK AT THE OLD PRIORITIES MAYBE THOSE WERE DONE AFTER. IF YOU CAN EXPLAIN THAT. >> NOT NECESSARILY AFTER. I THINK IT INFORMS -- IT WAS ALWAYS DONE BEFORE THE ABSOLUTE BUDGET. IT WAS DONE EARLIER THAN MANY OF THE INSTITUTES AND CENTERS HAD STARTED TO PUT TOGETHER THEIR PRIORITIES FOR RESEARCH WITHIN EACH INSTITUTE AND CENTER. IT ENSURES THAT WE'RE OUT AHEAD OF ALMOST ALL OF THE ICs, THERE AREN'T ADJUSTMENTS THAT NEED TO BE MADE WHAT COMES UP THROUGH THE TRANS-NIH PLAN. >> LINDA. >> I WAS GOING TO SAVE THIS FOR LATER BUT SEEMS MORE APPROPRIATE NOW. WHAT ONE THING, THE RFI RESPONSE THE LITTLE PIE CHART I'M NOT SURE WHERE OUR GROUP WAS IN THIS , BUT I JUST WONDER, WE SENT IN ONE RESPONSE BUT IT WAS FROM LIKE 30 ORGANIZATIONS. THAT MIGHT BE -- THOSE RESULTS OF COMMUNITY PARTICIPATION MIGHT BE A LITTLE BIT SKEWED BY THAT. >> THAT LIKELY CAME IN WITH PARTNERSHIPS AND NETWORKS. THAT'S JUST THE NUMBERS OR SORT OF THE -- >> YEAH. I THINK THE POINT IS THAT THAT MAY HAVE BEEN 13.5% BUT MIGHT REPRESENT LOT MORE PEOPLE THAN THAT MIGHT SEEM. >> WHEN I SAY 13.5% WE GOT 13.5% OF THE RESPONSES CAME FROM GROUPS LIKE YOURS. NOT THE ACTUAL RESPONSE ITSELF, WHAT WAS THE CLASSIFICATION OF GROUPS THAT PUT IN RESPONSES. YOUR GROUP MAY HAVE PUT IN 35 RESPONSES. >> WE PUT IN ONE FOR LIKE 35 PEOPLE. 35 ORGANIZATIONS. >> THAT'S PARTNESHIP AND NETWORKS. THOSE ANSWERS CAME FROM GROUPS LIKE YOURS THAT CAME TOGETHER. >> REPRESENT LOT MORE ORGANIZATIONS THAN IT SEEMS. I SAY THAT BECAUSE I HELPED PUT THAT TOGETHER AND SUBMIT THAT AND ONE OF THE REALLY BIG CONCERNS IN THE COMMUNITY IS BEHAVIORAL RESEARCH, IMPLEMENTATION SCIENCE AND THAT CROSS CUTTING THING IS SO IMPORTANT AND IT JUST NEVER SEEMS TO GET THE ATTENTION IT DESERVES. WHEN YOU THINK ABOUT THE CASCADE , WHEN YOU THINK ABOUT THE GOOD JOB CDC HAS BEEN DOING ABOUT -- WITH PREPARE GETTING PEOPLE, HOW MUCH WE NEED THIS FOR CURE RESEARCH ALWAYS LIKE THE BASTARD STEP CHILD. WE LIKE TO SEE THAT CHANGE BECAUSE IT'S SO VERY IMPORTANT TO DEVELOP ALL THESE DRUGS THEN NOBODY TAKES 'EM. DON'T TAKE 'EM FOREVER. >> WHEN I BROKE DOWN -- WHAT I DIDN'T DO SHOW YOU THE ACTUAL BREAK DOWN OF WHAT EACH OF THE -- WHAT THE NAC WORKING GROUP WAS ASKED TO PROVIDE US IN PUT. FOR EACH OF THE DIFFERENT PRIORITIES THEY WERE ASKED TO PROVIDE WHAT'S BASIC SCIENCE AND TRANSLATIONAL SCIENCE, WHAT'S THE CLINICAL, WHAT'S THE BEHAVIORAL AND SOCIAL SCIENCE, WHAT'S THE IMPLEMENTATION SCIENCE THAT'S APPLICABLE TO EACH OF THE DIFFERENT OVERARCH ING PRIORITIES. IT IS COVERED. IN 'D TO THE CROSS CUTTING AREAS WE'VE ASKED FOR BEHAVIORAL AND SOCIAL SCIENCE WHICH IS CROSS CUTTING AREA, BASIC SCIENCE WHICH IS CROSS CUTTING AREA. THOSE THINGS WERE -- WILL BE COVERED AS PART OF THE PLAN. >> I GUESS WHAT I'M SAYING IS LET'S JUST MAKE SURE THEY'RE FUNDED. [ LAUGHTER ] >> YOU KNOW, LINDA -- >> THANKS FOR YOUR ATTENTION. >> ANY OTHER DISCUSSION OF THIS? I THINK IT'S -- I THINK THIS IS A GREAT LIST IF ANYONE WANTS TO DISCUSS A LITTLE BIT MORE HOW THEY PARSE OUT OR MAKE THIS CLEAR WE DO HAVE A LITTLE BIT OF TIME BEFORE DR. SHARPLESS WILL COME FROM THE NCI THIS IS OUR TIME FOR DISCUSSION. LET'S DISCUSS. DOES ANYONE HAVE ANY -- ANYONE HAVE ANY BURNING COMMENTS THEY WANT TO MAKE? WE CAN THINK ABOUT THIS IN COMBINATION WITH DR. FREUND'S PRESENTATION HOW THINGS WILL BE REVIEWED FROM NOW ON. I'D LIKE TO MAKE COMMENT ON RESEARCH AND TRAINING FOR EARLY AND MID CAREER INVESTIGATORS THAT I THINK NIH DID REALLY GOOD JOB PUTTING FORTH HOW IMPORTANT EARLY INVESTIGATORS WERE THIS YEAR, AS YOU KNOW, WE'VE TALKED ABOUT IN THIS GROUP THERE'S A LOT OF ANXIETY THAT EARLY INVESTIGATORS HAVE AS THEY WATCH BUDGETS GO BACK AND FORTH THEY THINK ABOUT THEIR ACADEMIC CAREER. I THINK WE CAN'T STRESS ENOUGH HOW KEEP ON PUTTING OUT THOSE MESSAGES FROM THE NIH THAT TALK ABOUT THE EMERGING INVESTIGATOR I THINK LIKE ONE MESSAGE CAN MAKE PEOPLE FEEL VERY SUPPORTED. I WOULD JUST MAKE THAT COMMENT. ANY OTHER COMMENTS OR DISCUSSION RIGHT NOW? OR I'LL HAVE TO CALL ON YOU. >> I'LL SAY SOMETHING FROM THE INSTITUTE PERSPECTIVE. I THINK OVER THE YEARS THIS DOCUMENT HAS BEEN -- HAS EVOLVED IN WAY THAT GOT TO POINT WHERE IT WASN'T THAT USEFUL. WHAT HAS HAPPENED WITH THIS KIND OF A RESET, AN 'DEPARTMENT TO GET BACK TO WHERE WE WERE IN TERMS OF THE TYPES OF PRIORITIES THAT WERE BEING SET. IT'S NOT GOING TO BE EVERYTHING WE'RE DOING BUT REALLY SET OF PRIORITIES. THIS IS ESSENTIAL STEP. GOOD EXERCISE, WE'RE GETTING THERE, IT'S REALLY GOOD. >> MAYBE THIS IS MORE ABOUT LOGISTICS OF THINGS. BACK TO THE COMMENT ABOUT WANTING TO SEE THINGS FUNDED, HOW DOES PLAN LIKE THIS TRANSLATE INTO PAs OR FUNDING CUTOFFS AND THAT SORT OF THING? IS THERE A DIRECT RELATIONSHIP BETWEEN THE PRIORITIES HERE AND HOW THE DIFFERENT AREAS ARE FUNDED? [ INAUDIBLE ] >> -- ANY OF THESE OVERARCHING PRIORITIES, THAT'S NOT A PA THAT IS CONSIDERED TO BE A HIGH PROCEED COURT PA FOR FUNDING WHEN IT GETS SENT TO US WE SEND IT BACK TO THE IC SAY THAT'S NOT CONSIDERED HIGH PRIORITY. IF IT FITS IN, THESE ARE LARGE BUCKETS, THEY'RE BROAD BUCKETS IN THAT SENSE OF TRYING TO PROVIDE APPROPRIATE COVERAGE IT INFORMS HOW THOSE PAs BECAUSE INSTITUTES AND CENTERS KNOW WHAT IS IN THE TRANSNIH PLAN. IT'S A RARE EVENT THESE DAYS THAT WE HAVE THINGS THAT COME THROUGH THAT DON'T -- THAT DON'T FIT BECAUSE WE'VE BEEN TALKING ABOUT THIS NOW FOR -- SINCE 2015 I THINK. '15-16. >> LINDA. >> I'M ALWAYS INTERESTED IN ACTUAL COLLABORATION LIKE NUTS AND BOLTS OF THAT AND HOW MANY -- I GUESS USED TO THE NIH BEING BYZANTINE. I COME FROM A TIME WAY BACK WHEN INSTITUTES WOULDN'T COLLABORATE WITH EACH OTHER I THINK I SAID EARLIER THAT I'M ENCOURAGED BY MORE COLLABORATION HAPPENING. HOW DO YOU GET TOGETHER WITH THEM TO MAKE SURE THERE'S BUY IN , WHAT'S THE PROCESS THERE, NUTS AND BOLTS SORT OF TO GET THE OTHER INSTITUTES TO LISTEN TO YOU AND TO COLLABORATE AND ACCEPT SUGGESTIONS AND HOW DO YOU REALLY GET -- TALK ABOUT IMPLEMENTATION SCIENCE, RIGHT? >> I THINK ONE OF THE BETTER EXAMPLES OF THAT IS PROBABLY WHAT'S HAPPENING WITH MULTI- CENTER AIDS COHORT STUDY WHICH IS MEN'S FOLLOW UP AND WOMEN'S INTER-AGENCY HI WHICH IS WOMEN'S -- GOING FORTH THEY'RE NOW WORKING ON THEIR APPLICATION FOR SINGLE NETWORK THAT WILL DO -- SINGLE NETWORK COHORT OF BOTH MEN AND WOMEN. IT MEANT TAKING PROJECTS THAT WERE INDIVIDUALLY ABOUT FOUR OR FIVE OF THE ICs MAY HAVE WORKED TOGETHER WORKING ON THIS THERE ARE 12 OR 13 NOW. PEOPLE COMING INTO A ROOM WE DO 134 WORK TALKING TO THE INDIVIDUAL -- I DON'T, THE GROUPS OF US DO SOME WORK TALK ING TO THE INDIVIDUAL PROGRAM DIRECTORS, INSTITUTE DIRECTORS ABOUT THE OPPORTUNITIES HERE THEN BRING PEOPLE INTO THE ROOM THEN LET THEM COME UP TO OUR -- HOW THIS SHOULD HAPPEN NOT US SAYING YOU HAVE TO DO THIS OR THAT IT IS TALKING ABOUT WHAT THE OPPORTUNITIES ARE. THE ICs ARE INCREDIBLY WILLING TO WORK TOGETHER TO -- FOR COMMON GOAL. I THINK ALL OF US SEE WHAT THE OUTCOMES NEED TO BE AND WHAT THE GOALS ARE AND RECOGNIZE THE IN ABILITY OF SINGLE INSTITUTE OR CENTER TO BE ABLE TO DO THAT BY THEMSELVES, THEY WELCOME THE SHARING OF RESOURCES BOTH MONETARY BUT ALSO THE SHARING OF INTELLECTUAL RESOURCES. WE HAD SOME TREMENDOUSLY INTERESTING CONVERSATIONS ABOUT KIND OF SCIENCE THAT NEEDS TO MOVE FORWARD WITH SOMETHING LIKE X AND Y. THE COHORT STUDY DOING ANOTHER VARIATION ON THAT BY INVITING WHAT SOME OF THE ADULT FOLKS ARE DOING INTO THESE CONVERSATIONS TO FIGURE OUT HOW YOU START TO HARMONIZE DATA. THESE ARE JUST TWO EXAMPLES. THERE ARE MANY EXAMPLES OF THIS HOW TO GET OTHER INSTITUTES AND CENTERS AND THEIR EXPERTISE INTO THE ROOM. I DON'T THINK WE'VE HAD A SINGLE OR RARE EVENT THAT ANYBODY DOESN'T WANT TO BE PART OF THIS. HOW CAN WE WORK TOGETHER FOR COMMON GOAL. >> ONE THING ALZHEIMER'S RESEARCHERS ARE THERE COLLABORATIONS WITH THEM. >> THERE'S AN FOA THAT -- THAT'S LOOKING AT THE ISSUES, PARTICULARLY ISSUES OF ALZHEIMER'S IN HIV, PEOPLE LIVING WITH HIV ALONG WITH PEOPLE NOT LIVING WITH HIV AND TRYING TO DETERMINE WHAT SOME OF THOSE DIFFERENCES ARE BUT ALSO WHAT SOME OF THE SIMILARITIES ARE SO THAT THEY CAN INFORM EACH OTHER. THAT TOOK BIT OF A CONVERSATION BETWEEN THE INSTITUTE OF AGING DIRECTOR -- >> I WAS JUST GOING TO JUMP IN ALSO REMIND YOU THAT WE DO HAVE THE ANY AIDS EXECUTIVE COMMITTEE THAT'S A GROUP THAT WE MEET WITH EVERY MONTH. WE HAVE A FORMAL MEETING WITH THEM AND ITS REPRESENTATIVES FROM VIRTUALLY ALL INSTITUTES AND CENTERS THAT RECEIVE HIV RESEARCH DOLLARS. IN ADDITION TO WHAT GINA DESCRIBED IN TERMS OF SPECIAL OPPORTUNITIES WE MEET WITH THEM EVERY SINGLE MONTH AND IT'S REALLY ROBUST MEETING THAT'S WHERE THEY BRING IDEAS ABOUT NEW PROJECTS, NEW INITIATIVES, FUND ING OPPORTUNITIES. I DON'T HAVE THE HARD DATA BUT THE NUMBER OF INSTITUTES AND CENTERS THAT COFUND IN THE FUND ING OPPORTUNITY AREA IS REALLY REMARKABLE. I THINK WE'VE GOT A GOOD FRAMEWORK TO DO THIS ON A REGULAR BASIS AS WELL AS FLEXIBILITY TO JUMP IN TO SPECIAL OPPORTUNITIES. THE AMOUNT OF COLLABORATION AND COOPERATION IS VERY IMPRESSIVE. >> DOES THE AMOUNT OF RESOURCES AVAILABLE TO THE ICs FACTOR INTO THE DECISION ABOUT WHAT TO COST SHARE? COULD YOU LOOK AT ONE IC SAY MAYBE THE -- THEY HAVE TON OF MONEY SO WE NEED TO BE MORE AGGRESSIVE IN TERMS OF SUPPORT ING RESEARCH WITH THE INVESTORS AND OTHERS THAT MIGHT HAVE LESS FUNDING, DOES THAT FACTOR IN TO YOUR DECISION AT ALL? >> I THINK IT'S -- SO THE SCIENCE IS WHAT DRIVES THE DECISION MAKING. IT'S NOT JUST THE AMOUNT OF MONEY. ALTHOUGH YOU MAY HAVE AN IC, FOR EXAMPLE, YOU GAVE THAT MAY HAVE MORE MONEY THAN ANOTHER SMALLER IC WE'RE ALSO TALKING ABOUT WHAT THEY HAVE IN TERMS OF HIV DOLLARS WHICH ISN'T NECESSARILY REFLECTED IN HOW MUCH MONEY THE ENTIRE IC HAS. NOT A DETERMINED PERCENTAGE. IT'S BASED ON WHAT SCIENCE GETS PUT FORTH. WE DON'T JUST LOOK SAY YOU SHOULD BE COST SHARING MORE BECAUSE YOU HAVE MORE MONEY IT'S WHAT THE SCIENCE DEMANDS OR WHAT THE SCIENCE -- HOW THE SCIENCE DRIVES THIS ISSUE OF SHARING COSTS AND ALSO SHARING COLLABORATION. >> PUBLIC COMMENT SECTION. SORRY. DURING THAT TIME, THANK YOU. ANY OTHER COMMENTS FROM THE COUNCIL BEFORE WE MOVE ON? SORRY. >> I WAS JUST GOING TO SAY THAT ONE OF THE THINGS THAT YOU MENTIONED WAS LOOKING, PICKING UP WHAT LINDA WAS SAYING, THE BEHAVIORAL AND SOCIAL SCIENCE AND IMPLEMENTATION SCIENCE ALONGSIDE EACH OF THE CATEGORIES I THINK THAT'S VERY USEFUL THING HAVE BEEN ON IC PRESENTATION THIS MORNING -- NOT IC, PRESENTATION THIS MORNING ABOUT NEW STUDY SECTIONS AND THERE SEEMS TO BE SENSE THAT -- OR COULD BE THAT CERTAIN OF THOSE CATEGORIES ARE VIEWED ONLY -- VIEWS AS OPERATING ONLY AT THE POPULATION LEVEL OR ONLY AT THE INDIVIDUAL LEVEL. IN FACT I THINK THAT IS SOMEWHAT ARBITRARY DISTINCTION. SO MAYBE STUDY SECTIONS MAY BE SET UP THAT WAY BUT WE SHOULD EN COURAGE INDIVIDUAL LEVEL AND POPULATION LEVEL INVESTIGATORS TO THINK ABOUT THESE -- BOTH OF THESE ISSUES. >> ALL RIGHT. GOING TO GO ON TO THE UPDATE FROM THE NATIONAL CANCER INSTITUTE ON HIV/AIDS RESEARCH ACTIVITIES. OVER THE LAST TIME WE'VE HEARD FROM DIRECTORS OF INSTITUTES ON HIV ACTIVITIES AND THEIR INSTITUTE THIS WILL START SERIES OF TALKS THAT WE'LL HEAR THIS AFTERNOON. WE WELCOME DR. NORMAN E. SHARP LESS WHO WAS SWORN IN AS 15 TH DIRECTOR OF THE NATIONAL CANCER INSTITUTE IN OCTOBER 2017 NCI LEADS AND CONDUCTS AND SUPPORTS CANCER RESEARCH ACROSS THE NATION TO ADVANCE SCIENTIFIC KNOWLEDGE HELP PEOPLE LIVE LONGER, HEALTHIER LIVES. PRIOR TO JOINING THE NIH DR. SHARPLESS WAS THE DIRECTOR OF THE UNIVERSITY OF NORTH CAROLINA LINE BERGER CANCER WHERE WHERE HE WAS -- MOLECULAR BIOLOGY OF CANCER AND AGING. THANK YOU VERY MUCH. THEN WE'LL HAVE DISCUSSION FOLLOWING THIS. >> GOOD MORNING, THANK YOU -- GOOD AFTERNOON I GUESS. I TIMED IT JUST RIGHT BECAUSE I FORGOT MY CARD I HAD TO GET X-RAYED ON THE WAY IN. THAT THROUGH OFF THE SCHEDULE A LITTLE BIT. I REALLY APPRECIATE THE OPPORTUNITY TO COME SPEAK TODAY. TOPICS OF AIDS RELATED CANCER IS VERY IMPORTANT IN THE NCI AND WE HAVE LARGE PORTFOLIO IN THAT AREA. I THINK THERE ARE SOME REALLY TREMENDOUS SUCCESSES TO TALK ABOUT ALSO AN ISSUE I'LL COME TO THE AT THE END OF THE TALK. BRIEFLY THIS IS REMIND ME TALK ABOUT MYSELF FOR A MOMENT. I STARTED OUT AS HIV RESEARCHER, MY FIRST JOB IN THE LAB WAS IN BUILDING 36 AT THE NIH WHEN I WORKED FOR NEUROVIROLOGIST WHO WAS STUDYING INFECTIONS OF THE BRAIN AND HIV WHEN IT WAS EMERGING. LIKE ALL PEOPLE INTERESTED IN CANCER I STARTED OUT AS TUMOR VIROLOGIST. THAT MIGRATED MORE TO MALIGNANCY AS MENTIONED I RAN CANCER CENTER THAT HAD VERY STRONG VIROLOGY PROGRAM, LOT OF WORK IN KHHV AND OTHER HIV ASSOCIATED CANCERS, THIS IS SOMETHING THAT I'VE TRIED TO KEEP UP WITH ENIN MY CANCER LIFE. THE OTHER THING TO SAY ABOUT THIS IS, I'LL TELL ONE STORY FROM BEING A CANCER CENTER DIRECTOR I WAS ACTUALLY UNIVERSITY OF NORTH CAROLINA BUILD THIS GORGEOUS NEW CANCER HOSPITAL AND WE WERE JUST START ING TO THINK HOW WE WOULD DO CELLULAR IMMUNOTHERAPY. CAR T CELLS. DAVID, WELL-KNOWN HIV RESEARCHER MOST OF YOU KNOW CALLED ME, COULD WE DO SOME CLINICAL TRIALS OF CELLULAR IMMUNOTHERAPY IN YOUR CANCER HOSPITAL. ALL THE PHYSICIANS IN THE CANCER HOSPITAL SAID, ABSOLUTELY NOT. THERE'S NO -- WE CAN'T TAKE CARE OF AIDS PATIENTS IN THE CANCER HOSPITAL THIS IS A CANCER HOSPITAL. I SAID, NO, ACTUALLY, WE CAN HELP YOU, DAVID, WE'LL BE HAPPY TO DO THOSE TRIALS. THEY WANT NURSES THAT HAD EXPERIENCE WITH INFUSION, CELLULAR PRODUCTS. SO I SORT OF CONTRAVENED WHAT EVERYBODY ELSE SAID, PEOPLE EAGER TO DO THOSE, TWO REASONS, FIRST OFF IS DAVID IS GOING TO CURE AIDS WE WANT TO BE IN THE PRESS RELEASE. SECONDLY, THOUGH, REALLY WAS SOMETHING IN IT FOR US. WE WERE GOING TO GIVE THESE SAME KIND OF CELLULAR PRODUCTS, THE IDEA HERE WAS TO USE LYMPHOCYTES BUT NOT REALLY THAT DIFFERENT FROM USING LYMPHOCYTES TO ATTACK CANCER. CAR-T CELLS. WE WOULD DO THOSE TRIALS I WANT ED TO GET SOME EXPERIENCE. IT SEEMED TO ME THAT WAS WORTHY LINE OF RESEARCH FOR US BECAUSE BENEFITED NOT ONLY PATIENTS WITH HIV BUT ALSO PATIENTS WITH CANCER WHO WERE BOTH GOING TO BENEFIT I BELIEVE IN THE FUTURE FROM CELLULAR IMMUNOTHERAPY. I'LL REVISIT WHY I THINK THAT'S TELLING STORY LATER. I DON'T THINK I NEED TO TELL THIS AUDIENCE ABOUT SORT OF CONTRIBUTION OF THE NATIONAL CANCER INSTITUTE TO HIV RESEARCH BUT IT REALLY IS -- EVEN I WHO WAS SORT OF AT NIH FOR THIS HAVE BEEN LONG TIME CANCER AND HIV ASSOCIATED MALIGNANCY WATCHER WAS BLOWN AWAY WHEN WE STARTED PUTTING TOGETHER THE CONTRIBUTIONS WITHIN THE NCI RELATED TO HIV RESEARCH JUST SHOWN SOME OF THESE HERE, SORT OF STARTS WITH BOB GALLOW AND BA RB AND SAM AND OTHERS AND CONTINUES TO THIS PRESENT DAY, I WON'T READ THEM ALL OUT. SUFFICE IT TO SAY WE'VE HAD IMPORTANT WORK ON PATHOGENESIS OF HIV, ON NOVEL DYING NOT PARTICULAR METHODS RELATED TO HIV AND LOT OF WORK IN THERAPEUTICS RELATED TO HIV. THAT CONTINUES TODAY THERE'S NO DIMINISHED COMMITMENT OR LOSS OF INTEREST IN THIS TOPIC OR ANY OF THAT. TRANSNATIONAL AND BASIC SCIENCE. HERE IS SORT OF A SLIDE OF THE CURRENT PORTFOLIO, AS YOU SEE IT BREAKS OUT ALONG LINES YOU MIGHT EXPECT THERE'S SOME THERAPEUTICS WORK, POT GENESIS WORK, INFRASTRUCTURE OF VACCINES, EPIDEMIOLOGY, WE DO ACTUALLY IMPORTANTLY SUPPORT A NUMBER OF STUDIES INTERNATIONALLY THAT I'LL SHOW LATER ON. A REAL GLOBAL ONCOLOGY PORTFOLIO AS I'M SURE MOST OF YOU ARE AWARE THE BURDEN OF HIV ASSOCIATED CANCERS IN MALAWI WHERE I USED TO RUN A HOSPITAL AT UNC IS VERY DIFFERENT. HERE IS SOME OF THE SORTS OF STUDIES I WANTED TO SHOW. THIS MAKES IMPORTANT POINT RELATED TO WHAT KINDS OF CANCERS THAT WE'RE STARTING TO SEE IN THE UNITED STATES NOW IN PATIENTS WHO ARE LIVING WITH AIDS. THE CLASSICS, CERVICAL CANCER, VIRALLY ASSOCIATED CANCER WE STILL SEE BUT IMPORTANT REALIZATION THAT THERE'S EXCESS OF SORT OF NONVIRAL ASSOCIATED CANCERS IN THESE POPULATIONS AS QUELL. SQUAMOUS IS HPV ASSOCIATED. LUNG CANCER IN PARTICULAR IS VERY IMPORTANT CAUSE OF MORTALITY IN THE UNITED STATES AND THERE'S A SIGNIFICANT INCREASE IN HIV ASSOCIATED -- IN THIS CANCER IN PEOPLE WITH LIVING WITH AIDS. THERE'S A LOT OF INTERESTING RESEARCH GOING ON ABOUT INFLAMMATION AND LUNG CANCER, THERE'S INTERESTING FINDING CARDIOLOGY TRIAL ABOUT ANTI- INFLAMMATORY MOLECULE THAT WAS DESIGNED TO PREVENT LIKE RHEUMATOID ARTHRITIS. AS WELL AS VERY STRONG STATISTICALLY SIGNIFICANT SIGNAL THAT WAS UNINTENDED IN THE ORIGINAL DESIGN. THAT IS A TOP THAT I CAN WE DON'T FULLY UNDERSTAND BUT IT'S VERY ROBUST FINDING FOR HIGH LEVEL CANCER. I WOULD ARGUE A GOOD AREA OF BIOLOGICAL INQUIRY THAT WOULD BENEFIT NOT ONLY PATIENTS WITH AIDS BUT PEOPLE WHO ARE GOING TO GET LUNG CANCER. I WOULD SAY, AS YOU'RE PROBABLY AWARE DEMOGRAPHICS OF HIV IN THE UNITED STATES HAS CHANGED DRAMATICALLY, REALLY FROM THE POINT OF VIEW OF CANCER RESEARCH HEAR THISTH MEANS AS POPULATION OF PATIENTS LIVING WITH HIV IS THE AVERAGE AGE INCREASES THE KINDS OF CANCERS THAT WE START TO SEE IN THE PATIENTS CHANGES QUITE A BIT AS I MENTIONED WE START SEEING MORE AND MORE OF THE CANCERS THAT PATIENTS WHO ARE OLDER IN THE UNITED STATES GET WHICH ARE PREDOMINANTLY CARCINOMA, LUNG CANCER, BREAST CANCER. ONE MORE FURTHER CLARIFICATION ON THIS POINT, BACK IN THE '90s THE AIDS ASSOCIATED MALIGNANCY PROBLEM WAS LARGELY ABOUT AIDS DEFINING CANCERS BUT NOW WE'RE SEEING REALLY BUILT CAN OF CANCER IN THIS POPULATION ARE BECOMING MORE OF THE NON-HIV -- NONCLA SSIC AIDS DEFINING MALIGNANCIES LIKE LUNG CANCER. IF PATIENTS WITH HIV LIVE TO OLDER AGE, THEN THEY START SEEING CANCERS THAT LOOK MORE AND MORE LIKE WHAT WE SEE IN THE GENERAL POPULATION OF THE UNITED STATES. CARCINOMAS AND HEAD AND NECK CANCER AND THINGS LIKE THAT. AS I MENTIONED WE HAVE PORTFOLIO THAT INCLUDES STUDIES THROUGHOUT THE WORLD, IN SUBSAHARAN AFRICA, FOR EXAMPLE, CAPACHIES THE MOST COMMON CANCER OF MEN AND CERVICAL CANCER IN WOMEN IN PLACE LIKE MALAWI. WHILE THE -- BOTH OF THOSE ARE STRONG HIV ASSOCIATED IN THOSE AREAS. THAT SPECTRUM STILL AS I SAID QUITE DIFFERENT FROM WHAT IS GOING ON IN THE UNITED STATES NOW WHERE IT USED TO BE MUCH MORE COMMON NOW IN THE ORDER OF SORT OF THOUSAND CASES A YEAR IN THE UNITED STATES. ONE WANTS TO DO CERTAIN KINDS OF TRIALS, BERKETTS LIKE. GREAT INTEREST IN EXPAND ING TRIALS INTER-NAEC NALLY TO 'PRESS SPECIFIC TYPES OF RESEARCH QUESTIONS. THIS IS AS I SAID WORTH NOTING ABOUT AFFECT OF HEART ON SPECTRUM OF CANCER IN THE UNITED STATES SHOWING THAT MOST FREQUENT CAUSE OF DEATH IN PATIENTS NOW IN THE UNITED STATES WITH HIV ACCORDING TO SOME SOURCES THIS IS SOMEWHAT CONTROVERSIAL TOPIC, BUT ACCORDING TO SOME SOURCES NOW MALIGNANCY INCLUDING NON-AIDS DEFINING MALIGNANCIES ARE BECOMING AN IMPORTANT CAUSE OF MORBIDITY AND MORTALITY IN THE UNITED STATES HIV POPULATION. BRIEFLY A WORD ABOUT THE ONGOING PORTED FOLIO AT NCI I JUST -- OF ABOUT 40 GOOD EXAMPLES OF THINGS THAT ARE GOING ON INTRAMURALLY AND EXTRAMURALLY. I CHOSE TO HIGHLIGHT TWO OR THREE. THIS WAS COOL STORY ABOUT A NOVEL THERAPEUTIC IS BEING DEVELOPED WITHIN NCI ONE OF THESE MATURATION INHIBITORS THAT TARGETS DIFFERENT STEP IN HIV PROCESSING THAT IS -- I THINK IS INTERESTING LINE OF INQUIRY IS GOOD FIT FOR OUR RESEARCH GIVEN OUR LONG HISTORY OF DEVELOPING SMALL MOLECULE THERAPEUTICS. SHOWING THAT THERE IS VERY LIMITED VIRAL REPLICATION THERE FOR AS IMPLICATIONS FOR SORT OF HOW THESE VARIABILITY OF THE VIRUS DEVELOPS IN FULLY REPRESSED HOST AND ARGUES THAT IT'S REALLY THE CLONAL PROLIFERATION OF INFECTED CELLS THAT'S MORE IMPORTANT THE BURDEN OF THESE PATIENTS THAN REPLICATION. I THINK THIS IS AN IMPORTANT STUDY ABOUT SOME VACCINE WORK TO WHICH I ALLUDED TO WHICH IS THE IDEA IS TO DEVELOP AN SI VIE VACCINE THEN TEST -- EFFICACY IN HUMANS USING WHAT IS SHOWN HERE. I THINK NOW UNDERSTAND SORT OF MODERN ERA OF COMBINING HEART WITH DIFFERENT REGIMENS LIKE EPO C MORE GENITAL WAY OF REDUCING REMIX WE HAVE VERY GOOD OUTCOMES IN BURR KIT'S-LIKE LYMPHOMA. SO, REAL PROGRESS IN THE TREATMENT OF HIV ASSOCIATED I THINK REALLY INTERESTING RESEARCH QUESTION IS THE USE OF CHECK POINTED INHIBITORS IN PATIENTS WITH HIV. SO AS YOU KNOW THESE DRUGS TARGET EXHAUSTED T CELLS AND PARTICULARLY EXHAUSTED T-CELLS ARE TARGETED AGAINST ANTI-TUMOR RESPONSE AND REAWAKEN THE CELLS LEAD TO BENEFICIAL ANTI-TUMOR RESPONSE. HAS ADDITIONAL COMPLICATIONS SO LIKEWISE COULD THERE BE SOME -- THAT'S NEGATIVE SIDE OF REACTIVATING EXHAUSTED T CELLS COULD THERE BE BENEFICIAL ANTI- VIRAL RESPONSE WOKEN UP BY USING THEM IN PATIENTS WITH CANCER. SO I THINK LOOKING AT THE EFFICACY OF THESE DRUGS WHICH REQUIRE FUNCTIONING T-CELLS IN HIV INFECTED POPULATIONS IS AN INTERESTING QUESTION. BUT ALSO LOOKING -- HAS ANY AFFECT ON SORT OF VIRAL RESERVOIR I THINK IS INTERESTING QUESTION. THIS IS ANOTHER PROJECT, AS MENTIONED AGE CANCER WHICH IS HP V ASSOCIATED. THIS LED IS TRIAL WITH CERVICAL CANCER PRECURSOR LESION CALLED H CELL AS WITH CERVICAL CANCER WE'RE SCREENING INTERVENTIONS TO REDUCE NEOPLASTIC CLONES WITHIN CERVIX ARE EFFECTIVE WE'RE NOW ATTEMPTING SUCH A TRIAL IN THE UNITED STATES IN THE ANCHOR STUDY WHICH IS THE IDEA, ACTUALLY, BOB IS THIS INTERNATIONAL TRIAL OR U.S. TRIAL? U.S. AND CANADA TRIAL. INTENT TO SCREEN LARGE NUMBER OF PATIENTS AND TRY TO REDUCE INCIDENCE OF PROGRESSION TO FULL BLOWN MALIGNANCY. AS IS THE CASE FOR CERVICAL CANCER. WE NOW HAVE -- BEEN WORKING ON PARTNERSHIP WITH OUR CENTER FOR GLOBAL HEALTH WHICH IS IN THE NCI. TO START THINKING ABOUT NEW WAYS OF DOING CLINICAL TRIALS IN COUNTRIES THROUGH OUR CANCER CENTER PROGRAM WE REALIZE THAT NOT REALLY THROUGH DESIGN BUT ALMOST ORGANICALLY, MANY OF OUR CANCER CENTERS OF WHICH THERE ARE ABOUT 70 DESIGNATED CANCER CENTERS HAVE STARTED DOING QUITE A LOT OF RESEARCH IN LOW AND MIDDLE INCOME COUNTRIES. AND FEW YEARS AGO THE NCI DECIDED IT WANTED TO TRY TO ORGANIZE THOSE GLOBAL ONCOLOGY EFFORTS AND NOW EVEN TALK ABOUT HOW YOU CAN DO CONSORTIA-LIKE TRIALS. THE INITIAL FOCUS WAS ON BURKITT 'S LYMPHOMA BUT WOULD LIKELY GO ON TO THOSE SHOWN HERE A BRIEF WORD ABOUT MY -- IN THE SIX MONTHS I'VE BEEN AT THE NCI I'VE LEARNED A LOT ABOUT HOW IMPORTANT FUNDING VIA OFFICE OF AIDS RESEARCH TO THE NCI'S MISSION BUT I'VE ALSO LEARNED ABOUT SOME OF THE LIMITATIONS ABOUT HOW WE CAN SPEND THOSE FUNDS. AS I'M SURE THIS GROUP IS MUCH MORE FAMILIAR THAN I, THERE IS THIS POLICY ABOUT CHOOSING TOPICS FOR RESEARCH AS HIGH PRIORITY AND LOW PRIORITY THE PRESIDENT OF THE NCI IS RESTRICTED TO THE USE OF NCI FUNDS FOR HIGH PRIORITY TOPICS. THAT MEANS THAT WE CAN WORK ON PATIENTS WHO HAVE CANCER AND HIV NO DISPUTE THERE THAT'S A GOOD TOPIC. WE CAN DO RESEARCH ON HIV SPECIMENS OR HIV OR TUMOR PATHOGENESIS AND KAPOSIS. BUT WE CAN'T WORK ON EBV AND HPV WHICH SEEMS TRAINING. UNITED STATES ABOUT SIX TIMES AS MANY PEOPLE WILL GET EBV -- SIX TIMES AS MANY PATIENTS WITH HIV WILL GET EBV AS OPPOSED TO KHHV. BUT EPBV IS A BIGGER DILLER OF AMERICANS AT PRESENT, HPV EVEN FURTHER. THEN THERE'S STUDIES LIKE BASIC IMMUNOLOGY WHICH I'M NOT SURE QUALIFY UNDER THE PRESENT SYSTEM FOR EXAMPLE, THAT WORK I DESCRIBED WITH DAVID MARGOLIS THE CURE AIDS STUFF REALLY LOOKS TO ME LIKE ITS FOR THE MOST PART THE BASIC SCIENCE OF CURE AIDS. HOW YOU WAKE UP A LATENT VIRUS, HOW YOU GENERATE CAR-T CELLS HOW YOU MAKE THEM, NONE OF THAT STUFF REALLY LOOKS LIKE IT WOULD FALL UNDER HIGH PRIORITY AREA YET -- I WOULD ARGUE THAT IF THE NCI WERE GOING TO WORK ON CAR-T CELLS MOST OF THAT EFFORT AIMED AT PATIENTS OUT HIV BUT SOME IS WOULD BENEFIT PATIENTS WITH HIV. SOME PORTION OF THAT CERTAINLY NOT MAJORITY BUT SOME PORTION COULD BE CONSIDERED RESEARCH BENEFIT OF PATIENTS WITH AIDS. MY CONCERN IS THAT THE RULES ARE ACTUALLY FORCING US TO WORK ON THINGS THAT ARE NOT IN THE PATIENT'S BEST INTEREST. THIS IS NOT ALLY BY THE NCI DIRECTOR TO MISAPPROPRIATE FUNDS USE THEM ON COLON CANCER OR SOMETHING BUT I DON'T THINK THAT I'M ABLE TO SPIN THINGS IN AREAS WHERE I THINK MOST INTERESTING QUESTIONS FOR PATIENTS WITH HIV BECAUSE OF THE LIMITATIONS. LIKE EBV ONE I MENTIONED. TO SORT OF SHOW AN EXAMPLE HOW THIS AFFECTED US RECENTLY THIS WAS THE 2015 PROVOCATIVE QUESTIONS WE ISSUED. THE NCI STARTED UNDER HAROLD HAS THIS PQ, THE NCI DIRECTOR AND COLLEAGUES COME UP WITH THE KEY QUESTIONS IN A FIELD. WE DID COME UP WITH SOME PQs RELATED TO HIV. BUT IF YOU LOOK AT THE QUESTIONS THEY'RE PRETTY NARROW. THEY ARE REALLY MUCH LESS SORT OF BASIC BIOLOGY THAT MIGHT BE RELEVANT TO PATIENTS WITH HIV. THE FIRST THREE ARE THE SAME THING LIKE HOW DOES INFLAMMATION CONTRIBUTE TO HIV. NOT A BAD QUESTION. BUT THE UNIVERSE OF THINGS WE WOULD HAVE CHOSEN IF WE DIDN'T HAVE TO WORRY ABOUT THIS HIGH- LOW PRIORITY BUSINESS WOULD HAVE BEEN DIFFERENT. JUST LAST THING MAKE THE POINT HAVING REAL IMPACT. AS I SAID I WOULD PROBABLY ARGUE THAT IN THE UNITED STATES THE EB V SPEND PROBABLY MORE IMPORTANT FOR PATIENTS WITH HIV YET THAT IS GOING DOWN WHERE AS OUR KKSHV IS GOING UP BECAUSE THAT ALWAYS QUALIFIES. THAT DECISION IS NOT LIKE ACADEMIC. THIS IS SOMETHING THAT I DEAL WITH AT EVERY COUNCIL MEET WHEN WE TO GO OUR BOARD OF ADVISORS SAY WE LIKE TO SPEND MONEY ON THIS TOPIC NOT THAT TOPIC. HIV IS SOMETHING -- IT'S $280 MILLION PORTION OF THE NCI PORTFOLIO. SIGNIFICANT AMOUNT OF FUNDING. THIS IS ANALYSIS BY BOB BY THE WAY. I THINK THAT WHILE PROPOSAL THAT CAME ABOUT WITH THIS SORT OF VERY STRONG VIEW OF HIV FUNDING VERSUS LOW PRIORITY HAD LAUDABLE INTENT, I UNDERSTAND WHY WE GOT THAT, WHERE THAT POLICY CAME FROM, I THINK IS ACTUALLY BECOME OVERLY RIGID AT LEAST FOR THE NCI. SIMILARLY SPOKE ENTO TONY AT NIA D I THINK HIS VIEWS ARE SIMILAR TO MINE THAT THERE ARE THINGS THAT NIAD WOULD LIKE TO DO THAT THEY FEEL SOMEWHAT LIMITED BY PRESENT CONCERNS ABOUT WHAT IS GOING TO BE DESIGNATED HIGH OR LOW PRIORITY. TO FURTHER UP, THIS POINT THAT E BV IS A BAD PROBLEM IN PATIENTS WITH HIV. VARIETY OF DIFFERENT TUMOR TYPES , BURKITT'S, CNS LYMPHOMA, IT'S NOT 100% OF ANY OF THEM. I THINK IT WOULD BE REASONABLE TO SAY THAT SOME PORTION OF EBV ASSOCIATED CANCER RESEARCH WOULD BE REASONABLY CONSIDERED HIV RELATED, SOME PORTION WOULD NOT. I'M ARGUING FOR THIS IDEA OF COST SHARING TO DESIGNATE OF T- CELL BIOLOGY OR SOME PORTION OF CAR-T MANUFACTURER OR SOME PORTION OF EBV RESEARCH AS BEING BENEFIT TO HIV PATIENTS. WITH THAT I'D BE HAPPY TO TAKE ANY QUESTIONS ABOUT NCI'S VISION OR COST SHARING OR OTHER OPPORTUNITIES OF B. THANK YOU FOR THE OPPORTUNITY TO COME TODAY. >> THANK YOU SO MUCH. WE'LL OPEN THIS UP FOR QUESTIONS AND COMMENTS, THIS RELATES NICELY BECAUSE WE TALKED ABOUT COST SHARING. >> I KNEW THAT WAS ON YOUR DOCKET. >> VERY FULL CIRCLE. >> GIVE ME AN OPPORTUNITY TO VISIT. >> THANK YOU SO MUCH. WHO HAS A COMMENT, PLEASE, LIZ. >> CAN YOU SAY YOUR NAME, TOO, I CAN'T SEE NAME TO GO FROM HERE. >> HI, I'M LIZ. I WANTED TO ASK, I GUESS TO ME IT'S JUST MIND BOGGLING THAT PH V WITH CERVICAL CANCER BEING SUCH A MAJOR CAUSE OF DEATH IN WOMEN INCLUDING HIV INFECTED WOMEN IN SUBSAHARAN AFRICA THAT THIS IS NOT CONSIDERED TO BE A HIGH PRIORITY. >> LET ME BE CLEAR. HPV RESEARCH IS A VERY HIGH PRIORITY FOR THE NCI. IN FACT I WOULD ARGUE THAT OF ALL THE THINGS THE INTRAMURAL PROGRAM DOES WELL, HPV RESEARCH MAY BE NUMBER ONE BASED ON SOME METRICS THAT WE LOOKED AT, DOUG AND COLLEAGUES, IT'S REALLY AN AREA WHERE THE NCI HAS LONG STANDING TRADITION OF GREAT RESEARCH. THE IMPACT THAT HAVE RESEARCH IS TREMENDOUS WORLDWIDE. DEVELOPMENT OF VACCINE, THE USE WILL HAVE MAJOR IMPACT ON CANCER ONLY PART THAT IS NOT HIGH PRIORITY IS HPV AS IT RELATES TO HIV MALIGNANCY, THAT SEEMS ODD. WE'LL WORK ON HPV. NCI WILL HAVE HUGE PORTFOLIO IN THAT TOPIC BUT RIGHT NOW IF I'M USING O.A.R. FUNDS TO FUND THAT RESEARCH THEN THERE'S THIS PROCESS WHERE IT GETS NOTED AND TAKEN AWAY AT SOME POINT. THEN REDISTRIBUTED FOR SOME OTHER PURPOSE. I THINK THAT IS NOT IN THE BEST INTEREST OF PATIENTS WITH HIV BOTH IN THE UNITED STATES AND INTERNATIONALLY. BUT THAT RESEARCH IS GOING TO HAPPEN NO MATTER WHAT POLICY WE COME TO WITH REGARD TO COST SHARING IT IS SUCH AN IMPORTANT AREA FOR THE NCI. >> IS THERE SOME WAY TO MAKE IT A HIGH PRIORITY HIV RESEARCH? >> I THINK -- MY UNDERSTANDING IS HISTORY WAS THAT -- IN DAYS GONE BY THAT SHOCKINGLY SOME OF THE INSTITUTES AND CENTERS WERE LESS CIRCUMSPECT. THERE WAS BROADENING OF SCOPE TO THE POINT WHERE THINGS -- MONEY WAS BEING SPENT ON THINGS THAT WASN'T HIV RESEARCH, NOBODY WANTS. THAT'S A PROBLEM. THE SOLUTION THAT CAME FORWARD WAS TO BE MUCH MORE RIGOROUS ABOUT WHAT IS AND ISN'T HIV RESEARCH. THAT'S LAUDABLE. I THINK LOT OF MERIT TO THAT, THAT'S THE WILL OF CONGRESS THAT CERTAINLY WE STILL NEED GOOD RESEARCH IN THE BIOLOGY AND TREATMENT OF HIV ASSOCIATED CANCERS. BUT MY ONLY ARGUMENT AT THIS POINT IS THAT POLICY COULD USE SOME TWEAKING. FOR EXAMPLE, I WOULD BE HAPPY IF WE SAID, 30% OF HPV RESEARCH. IT CAN'T BE A SOLUTION THAT IS GRANT BY GRANT WE CAN'T EXPECT MAUREEN'S STAFF TO LOOK AT EVERY GRANT SAY YES, YES, NO, NO. THEY NEED SOME GUIDANCE ON TOPICS BUT ONE COULD COME UP WITH A LIST OF -- NOT HUNDRED TOPICS, PROBABLY 30. THAT YOU WOULD SAY THIS PORTION -- IF THIS ABSTRACT IS DESIGNATED OF THIS TOPIC, SAY EB V ASSOCIATED CANCERS. WE'D SAY WELL EBV ASSOCIATED CANCERS AUTOMATICALLY, 30% IS O.A.R. AND 70% IS NCI OR WHATEVER NUMBER MAKES SENSE. I'M SURE WE HAVE ROBUST, WONDERFUL DISCUSSION HOW TO BREAK DOWN THOSE TOPICS. I THINK B CELL BIOLOGY, T CELL BIOLOGY, HFV, EVB IS PRETTY OBVIOUS. ONE I WORRY ABOUT IN CANCER COMES UP ALL THE TIME THAT CANCER NOT ONE DISEASE, A THOUSAND DISEASES IF YOU HAVE ONE OF THESE RARE CANCERS YOU HAVE THIS IS A CONDITION SER WITH ONE MUTATION IN IT WE HAVE NO GOOD IDEAS. WHEN ADVOCACY COMMUNITY COMES TO ME SAYS TO ME I WANT TO YOU WORK ON THAT TUMOR TYPE I SAY ONLY THING WE CAN DO USEFUL ARE NOT THE ONLY THING, MOST USEFUL THING BASIC SCIENCE. NONE OF OUR THERAPEUTIC MODALITIES THAT EXIST TODAY IS REALLY GOOD USE OF FUNDS. BIG CLINICAL TRIALS NOT GOING TO HELP ANYBODY. I WOULD ARGUE THAT THAT APPLIES TO HIV AS WELL THAT THERE ARE SOME TOPICS WHERE MORE TRANSLATIONAL RESEARCH WHICH IS WHAT THIS POLICY PRIORITIZES IS LAUDABLE. NOT IN THE PATIENT'S BEST INTEREST TO EXCLUDE. WHICH I THINK POLICY UNINTENDED CONSEQUENCES OF THAT. >> DAVE SMITH FROM SAN DIEGO. THOSE SIX IMPORTANT QUESTIONS THAT YOU ASKED, HOW WERE THE RESPONSES IN TERMS OF NUMBER OF APPLICATIONS DID YOU THINK, ALSO THIS ONE, IN TERMS OF MILLION DOLLARS SPENT AS WELL BETWEEN HIV AND EBV, WAS THERE DIFFERENCE NOT JUST NUMBER SPENT BUT NUMBER OF APPLICATIONS? >> THIS IS BEFORE MY TIME. I'LL LET BOB TALK ABOUT OUR -- HOW WE FELT ABOUT RESPONSE TO THE PQs. BOB, DO YOU WANT TO SAY ANYTHING ABOUT THAT? >> PARTICULAR VIRUS OR SUCH, THESE WERE REALLY PUT UP HERE TO SHOW JUST HOW FLARE ROW THE BASIC RESEARCH THAT WE FELT THAT WE COULD FUND WITH THE HIGH PRIORITIES. IN TERMS OF OVERALL GRANTS WITH KSHV AND EBV THEY ARE SCORED BY CSR WE TEND TO SCORE THEM BASICALLY ACCORDING TO THE NUMERICAL SCORES. WE WILL SOMETIMES -- WE'VE HAD R FA THAT IS IN CLUEDED KSHA RESEARCH, FOCUSED ON AIDS MALIGNANCIES THAT MEET THE HIGH PRIORITIES ON THOSE PARs WE'RE ABLE TO FUND ADDITIONAL GRANTS WITH DSHV. WE DO FUND BIT MORE BUT GET ROBUST GRANTS PUT IN FOR BOTH OF THEM. AGAIN PEOPLE PUTTING GRANTS BASED ON WHAT THEY THINK WHERE THE MONEY'S AVAILABLE. ALL THESE THINGS TRICKLE DOWN EFFECTS AT MULTIPLE LEVELS. >> THESE PQs LOOK GREAT, RIGHT SOME I WAS JUST WONDERING IF YOU HAD ACTUAL RESPONSES TO THOSE PQ s THAT SEEMED ADEQUATE. OR WAS IT REALLY LIMITING THE NUMBER OF GOOD SCIENCE THAT WAS COMING? >> AS I RECALL WE DIDN'T USE ALL THE MONEY THAT WAS SET ASIDE FOR THESE PQs BECAUSE WE DIDN'T FEEL THAT THERE ARE ENOUGH -- WE FUNDED MAYBE 70% -- IS THAT -- I THINK WE FUNDED ABOUT 70% OF THE MONEY THAT WE SET ASIDE FOR IN PART BECAUSE THERE WEREN'T COMPLETELY ENOUGH GRANTS BUT AGAIN ISSUE WAS THAT THE PQs THEMSELVES WERE VERY NARROW. THAT'S THE CONCERN THAT WE'VE HAD WITH THEM. AND THE OTHER -- [ INAUDIBLE ] >> COULD I SAY ONE THING ABOUT K SHV. AT OUR MOST RECENT COUNCIL WE PROPOSED AN RFA OR SPECIAL FUND ING OPPORTUNITY RELATED TO BASICALLY TISSUE BANKING, BIO BANKING RELATED TO KSHV. AND OUR COUNCILORS THOUGHT THAT WAS LAUDABLE AREA OF INVESTIGATION, DIDN'T HAVE MAJOR PROBLEMS WITH THAT THEY SAID WHY DON'T YOU BROADEN -- THAT'S FAIRLY NARROW AND SPECIFIC WE CAN USE BIOBANKING AND WE'RE STUCK IN THIS SORT OF COMPLICATED POSITION. THERE'S THE ANSWER -- MAIN ANSWER IS THAT THE USE OF FUNDS, RIGHT? THE COST SHARING WOULD PRECLUDE US FROM SPENDING CERTAIN KINDS OF MONEY ON THAT TOPIC. AS I SAID, I FEEL LIKE MORE THAN ONCE I'M IN THIS POSITION WHERE I'M ASKED TO DEFEND SOMETHING, A DECISION BY THE NCI RELATED TO VIRAL INDUCED CANCERS, A LOT THAT HAVE IS DRIVEN BY WELL MEAN ING POLICY THAT I THINK HAS BECOME SOMEWHAT INFLEXIBLE. >> AS MONICA SAID WE WERE JUST TALKING ABOUT THIS, FIRST LET ME CONGRATULATE BOB ON THE STUDY THAT'S BEEN SUCH A LONG TIME COMING AND SO IMPORTANT TO PEOPLE WITH HIV. YEAH, BOB. IT'S FUNNY THAT ALL OF THE THINGS YOU CHECKED OFF ESPECIALLY THE CURE RESEARCH AREA I HAD WRITTEN DOWN BEFORE I ACTUALLY LOOKED AT YOUR SLIDE. I'M GLAD THAT YOU MENTIONED ALL THOSE THINGS. JUST SO WE'RE CLEARF THIS -- IF THESE AIDS FUNDS CANNOT BE USED FOR -- THOSE CATEGORIES WERE CHANGED A LITTLE BIT YOU'RE SAY ING THAT THE NCI WOULD BE COMMITTED TO DOING MORE RESEARCH , 70-30 WHATEVER. YOU'RE COMMITTING TO THE IDEA OF DOING THIS COLLABORATION RESEARCH IF CERTAIN THINGS COULD CHANGE AND HELP YOU EXPLAIN WHY YOU'RE DOING CERTAIN THINGS. >> AS I SAID, IT'S LIKE THE HPV QUESTION. WE'RE COMMITTED TO DOING HPV RESEARCH, THE QUESTION IS HOW ARE WE GOING TO PAY FOR IT. AND IT IS NOT -- I DIDN'T BRING DATA BUT WE HAVE HAD A DECREASE IN OUR FUNDING OVER THE LAST FEW YEARS RELATED TO THIS POLICY. IT'S MILLIONS OF DOLLARS THAT YOU NO LONGER COME TO NCI BECAUSE OF THIS HIGH-LOW PRIORITY ISSUE. THOSE FUNDS MAY TO GO OTHER AREAS OF RESEARCH THAT ARE LAUDABLE AND GREAT IN HIV. I'M NOT MAKING ANY STATEMENTS ABOUT THAT TODAY. BUT I CAN TELL YOU THAT THE UN ANTICIPATED CONSEQUENCE OF THIS WE WANT TO HAVE SORT OF WORK IN VIRALLY ASSOCIATED CANCER, DO MORE KSHV AND LESS OF OTHERS. THAT'S JUST SORT OF OTHER THE WAY IT WORKS. THE ROLE OF T CELLS IN CANCER IS LIKE ABOUT MOST EXCITIG THING IN ONCOLOGY RIGHT NOW. WE WOULD LOVE TO SPEND MONEY ON BASIC T CELL BIOLOGY LIKE WHY T CELLS GET OLD. WE'VE NOTICED WHEN YOU HAVE T CELLS FROM YOUNG DONORS WE CAN EXPAND THEM EX VIVO MAKE CAR T CELLS JUST GREAT. THERE'S A AGING OF THE IMMUNE SYSTEM THAT IS RELEVANT THAT PROCESS IS EXACTLY RELEVANT TO PATIENTS WITH CHRONIC HIV. BECAUSE THEY DESTROY AND REPLACE T CELLS. ALSO THIS ACCELERATED T CELL. A BASIC BIOLOGIC INQUIRY HOW DOES THAT WORK, WHAT IS THE CHANGE THAT MAKES T CELL OLD THAT'S GRANT THAT WOULD BE DIRECTLY RELEVANT TO THE USE OF CHECK POINTED INHIBITORS FOR CANCER THERAPY AS WELL AS PROGRESSION IN HIV. RIGHT NOW WE FUND THOSE KINDS OF GRANTS. WE HAVE ROBUST PORTFOLIO. BUT IT'S NOT WITH HIV FUNDS AT ALL, FOR EXAMPLE. I WOULD THINK THAT IT WOULDN'T BE DIFFICULT FOR MAUREEN AND COLLEAGUES TO COME UP WITH A SORT OF COST SHARING PLAN ON THESE TOPICS BECAUSE WE THINK ARE SORT OF EASY TO IDENTIFY THAT WOULD BE NONCONTROVERSIAL. I THINK EVERYBODY HERE WOULD AGREE, WOW, SIGNIFICANT PORTION OF HPV RESEARCH IS OF BENEFITS TO PATIENTS WITH HIV. THAT WOULD BE NOT A CONTROVERSIAL STATEMENT TO ANYONE. THAT WOULD ALLOW US TO -- AS WE THINK OF RFAs WE DON'T FOCUS ON KSHV WE HAVE ALL THREE VIRUSES OR FUND SOME LUNG CANCER WORK WHICH I THINK IS BIG KILLER NOW TRY TO MAKE CLEAR. THAT'S REALLY THE ISSUE IS THAT I FEEL LIKE POLICY IS CAUSING US TO DO THINGS THAT ARE NOT NECESSARILY IN THE BEST INTEREST OF PATIENTS. >> YOU'VE SAID THIS TEN TIMES. WE KNOW WHAT AIDS FUNDS CANNOT BE USED FOR, I GUESS I'M TRYING TO GET AT WHAT NCI FUNDS CANNOT BE USED FOR. YOU'RE ABSOLUTELY COMMITTED TO DOING THIS, A LITTLE BIT OF TWEAKING WOULD MEAN THAT MORE COLLABORATION WOULD HAPPEN. >> THAT'S ACCURATE. THE NCI FUNDS FOR MOST PART NOT COMPLETELY BUT COME TO THE DIRECTOR'S OFFICE AND CAN BE USED TO THE DIRECTOR'S DISCRETION FOR CANCER RESEARCH WHATEVER THE CANCER DIRECTOR DECIDES IS IS CANCER RESEARCH. WE ARE HEAVILY WATCHED BY CONGRESS HOW WE SPEND OUR FEDERAL MONIES, WE'RE VERY CAUTIOUS ABOUT THAT TOPIC. SOME OF THE FUNDING WE GET COMES THROUGH OTHER MECHANISMS. LARGEST PORTION THAT HAVE IS WHAT WE GET FROM THE O.A.R. WHICH IS HUNDREDS OF MILLIONS OF DOLLARS. THAT COMES WITH THIS SORT OF ADDITIONAL CHECK THAT NOT ONLY IS IT RELATED TO CANCER OR CANCER BIOLOGY, BASIC BIOLOGY, BUT ALSO GOT TO BE VALUE TO PATIENTS, TO THE PROBLEM OF AIDS , PROBLEM OF CHRONIC HIV INFECTION. I DON'T THINK THAT'S UN REASONABLE. CONGRESS ASKED FOR THAT. I DO THINK THAT IF WE'RE GOING TO HAVE SUCH POLICY WE OUGHT TO THINK ABOUT IT. BECAUSE IT CAN HAVE UNINTENDED CONSEQUENCES LIKE NOBODY STUDY ING HPV OR NOT NOBODY, BUT DECREASE IN THAT PORTFOLIO HE IS SPIFF I CANNILY AS IT RELATES TO PATIENTS WITH CHRONIC HIV INFECTION. >> YOU HAD A QUESTION THEN JONATHAN. >> I THINK SOME OF THE LAST COMMENT ADDRESSED THE QUESTION I HAD, WE'VE HEARD COMMENT FROM DR. CONNICK AND YOUR SUPPORT OF THE IDEA THAT THE PRIORITIZATION OF FUNDING FOR AIDS RELATED THROUGH NCI IS KNOTTED PERFECT. I WAS JUST HOPING TO YOUR APPROACH TO SOLVING THAT PROBLEM , WHAT IS THE PATHWAY, BECAUSE IT SEEMS LIKE YOU'RE IN AGREEMENT THAT THIS NEEDS TO CHANGE. I'M NOT SURE I UNDERSTAND HOW YOU WILL ACCOMPLISH THAT CHANGE. SOUNDS LIKE POLICY IS MORE -- MORE APPROPRIATE IN THE PRE-ART ERA. ISSUES THAT IS -- BEEN -- POST A RT ERA WE HAVE TO -- WHAT WE HAVE NOW DOESN'T WORK. >> I CAN SEE THIS GOING THREE WAYS. ADVICE OF THIS COMMITTEE WILL BE VERY IMPORTANT TO THAT DECISION. ONE, WE CAN KEEP THINGS THE WAY THEY ARE, IT'S NOT A TERRIBLE SYSTEM. I THINK THE VAST MAJORITY OF OUR PORTFOLIO FUNDS LAUDABLE STUFF THAT I BELIEVE IN. THAT WOULD BE ONE WAY TO GO. ANOTHER WAY WOULD BE TO SUDDENLY TWEAK THE PRESENT SYSTEM INSTEAD OF SAYING, IT'S BASICALLY THE PRESENT SYSTEM BUT FOR FEW TOPICS INSTEAD OF SAYING EBV ASSOCIATED CANCERS ARE NOT -- RESEARCH ARE NOT HIGH PRIORITY FOR HIV YOU CAN HAVE THIS MIDDLE GROUND WHERE YOU SAY THEY'RE 30% HIGH PRIORITY OR SOMETHING. SOME PORTION OF THAT WOULD THEN BE ALLOWED FOR THAT KIND OF RESEARCH. THAT NUMBER WOULD BE PRE SPECIFIED. BEFORE THE SPECIFIC GRANT WAS EVER LOOKED AT IF IT'S EBV ASSOCIATED GRANT WE SAY 30-50% WHATEVER. IS COMES FROM THE O.A.R. FUNDS REST COMES FROM THE NCI FUNDS. ONE COULD DO THE SAME THING FOR B CELL BIOLOGY OR T CELL OR HPV RESEARCH OR ANY OF THESE NUMBERS OF AREAS. THEN A THIRD -- I THINK BY THE WAY I HAVE DISCUSSED THAT IDEA WITH OTHER IC DIRECTORS, NOBODY THINKS IT'S A BAD IDEA. I TENTATIVELY DISCUSSED WITH FRANCIS COLLINS THEY'RE INTERESTED IN HEARING MORE. FRANCIS DOES HAVE PERSPECTIVE THAT THE BAD OLD DAYS THERE WAS A PROBLEM, WE DON'T WANT BACK TO THAT HE DOESN'T WANT POLICY THAT WOULD BE TOO FLEXIBLE BECAUSE IT COULD LEAD TO IC DIRECTORS FUND HANG THEY WANT TO FUND RATHER THAN STUFF THAT WOULD BE BEST USE FOR PATIENTS WITH HIV. THE THIRD OPTION WOULD BE FOR THIS COMMITTEE TO THINK NEITHER IS GOOD, LET'S COME UP WITH A THIRD NEW PROPOSAL I WOULDN'T BE FOR THAT. I THINK THAT THIS HAS BEEN DISCUSSED ENOUGH LATELY THAT PROBABLY -- SOLUTION A OR B WOULD BE BETTER THAN THAT. BUT THAT IS A QUESTION FOR YOU GUYS F. THERE'S A BETTER WAY TO DO THIS, YOU WOULD BE THE PEOPLE TO THINK ABOUT IT. I WILL LIVE WITH WHATEVER POLICY O.A.R. EVENTUALLY HITS UPON. BUT FROM MY POINT OF VIEW AS I SAID, I THINK IN THE BEST INTEREST OF PATIENTS WOULD BE A SYSTEM THAT IS MORE FLEXIBLE THAN ONE WE HAVE TODAY. BUT NOT DRAMATICALLY DIFFERENT. TWEAKED, SUDDENLY, COST SHARING OR -- >> I THINK THIS TWEAK CAN BE ACCOMPLISHED WITH COST SHARING BECAUSE WE HEARD LOT ABOUT IT BEFORE. >> THERE MAY BE OTHER WAYS TO TWEAK IT WE AREN'T TALKING ABOUT THAT SEEMS LIKE RELATIVELY STRAIGHT FORWARD ONE TO ME. >> JONATHAN, LAST FINAL COMMENT BEFORE THE BREAK. >> THANKS FOR REALLY HONEST AND COMPREHENSIVE DISCUSSION. SEEMS LIKE THERE'S THREE DIFFERENT TYPES OF RESEARCH AT NCI. THERE'S NCI LOOKING AT MALIGNANCY IN ITS TOTAL FORMS SAYING THESE ARE THE PRIORITIES BASED ON EITHER INTELLECTUAL CURIOSITIES, PUBLIC HEALTH IMPACT, SCIENTIFIC POSSIBILITY, WHATEVER YOU THINK. THEN YOU WOULD SEE WHAT PROPORTION THAT HAVE HAPPENS TO BE IN THE FIELD OF HIV THEN YOU WOULD REQUEST TO HAVE SOME OF THAT FUNDED. SECOND IS THAT YOU HAVE A PROJECT THAT YOU REALLY VALUE AND YOU THINK THAT IT WOULD BE HELPFUL TO HAVE SOME HIV RESEARCH TO SUPPORT IT LIKE BIO BANK F. NCI FELT IT WAS IMPORTANT TO HAVE BIOBANK OF -- [ INAUDIBLE ] THIRD IS THAT, WELL, THERE'S -- LIKE GOOD ACADEMIC WE SHOULD APPLY FOR IT. TRY TO THINK OF THE BEST IDEAS THAT WE HAVE WITHIN THE FIELD OF HIV. WHICH DID YOU DO? >> WE DO ALL OF THOSE. AS YOU TALK ABOUT YOU REMIND ME JUST TO MAKE ONE POINT CLEAR. WE HAVE SOME GIGANTIC INFRASTRUCTURE PROGRAMS LIKE CYR YOU KNOW WHAT THE CYR DATABASE, HUNDREDS OF MILLIONS TO AGGREGATE BIG DATA ABOUT PATIENTS WITH CANCER. IN FACT I WOULD ARGUE MOST OF THE -- WITH HIV IS FROM CYR. WOULDN'T BE PROPOSING THAT WE USE MONEY FOR THAT. BECAUSE THAT BY THE WAY WOULD BE -- EVEN 5 % WOULD BE LOT OF MONEY. I'M NOT SAYING THAT FOR THE BIG CLINICAL TRIALS, APPARATUS OR CY R OR THOSE THINGS THAT WE CONSIDER THEM I'M TALKING MORE ABOUT THE INVESTIGATOR INITIATED SCIENCE. AND SORT OF THE COOPERATIVE GROUP AGREEMENTS LIKE BIOBANK. >> WHAT I WAS SAYING I THINK YOU'RE KIND OFLY FOR BASIC SCIENCE RESEARCH COULD FALL UNDER THOSE SAME CATEGORIES AS WELL. >> I AGREE. THIS IS ALWAYS THE PROBLEM WITH BASIC SCIENCE, THERE COULD BE SOMETHING REALLY BASIC THAT YET MIGHT BE JUST THE THING TO CURE LOT OF PATIENTS. THE PROBLEM WITH BASIC SCIENCE YOU NEVER KNOW WHAT YOU'RE GO WILLING TO GET. THERE ARE CERTAIN BASIC B CELL AND T CELL IMMUNOLOGY THAT'S -- ANYTHING YOU LEARN IN THAT FIELD THAT'S REALLY IMPORTANT MECHANISTICALLY IS PROBABLY GOING TO BENEFIT PATIENTS WITH BOTH DANCER AND CHRONIC VIRAL INFECTIONS INCLUDING HIV. PROBABLY ARE SOME AREAS OF BASIC INVESTIGATION WHERE WE COULD SAY SOME PORTION WOULD BE HIV ASSOCIATED. I WOULD PROPOSE THAT PEOPLE LIKE THIS COMMITTEE ARE THE ONES WHO LOOK AT THAT LIST. I DON'T THINK WE SHOULD BE THE ONES TO COME UP WITH IT. ALTHOUGH I'M SURE OUR INPUT WOULD BE ASKED. I THINK REALLY IT WOULD BE VET TED BY PEOPLE WITH AN INTEREST IN HIV RESEARCH TO MAKE SURE IT'S NOT NEFARIOUS NCI DIRECTOR TRYING TO RUN OFF WITH THE FUNDS. >> I'M SORRY I DIDN'T RECOGNIZE THAT JENNIFER HAD ONE FINAL COMMENT. I THINK THAT IS OUR -- SORRY. WE HAVE TWO. REALLY FAST. AND DICK. REALLY FAST JENNIFER. >> JUST GOING TO MAKE A POINT TO CONNECT WHAT YOUR COMMENTS TO THE EARLIER DISCUSSION ABOUT COST SHARING I WAS ON THAT TASK FORCE. THE EXACT ISSUES THAT YOU'RE PRESENTING ARE THE ONES THAT WE GRAPPLED WITH. WE HAD THIS CONVERSATION JUST EVERYONE IS ASSURED THIS IS EXACTLY WHAT WE WERE LOOKING AT WE'RE AWARE OF THE WHOLE HISTORY AND WE'RE NOT TRYING TO -- WE ACTUALLY DIDN'T THROW OUT EVERYTHING BUT WE REALLY TRIED TO UPDATE IT I THINK. THE FRAMEWORK THAT WAS PRESENTED BEFORE WE'RE TRYING TO SHOW THAT WE INTRODUCED NEW ELEMENT THAT I THINK COULD BE A WAY TO LOOK AT THIS WHICH IS LOOKING AT THE INCIDENTS AND PREVALENCE FOR PEOPLE WITH HIV IN DIFFERENT SETTINGS. ALSO VERY COGNIZANT THAT THIS IDEA WOULD NOT BE ONE APPLY ON GRANT BY GRANT BASIS BUT TO BROAD AREAS. IT WAS VERY MUCH IN SYNC WITH WHERE YOU'RE COMING FROM. WE WEREN'T AS A TASK FORCE ASKED TO DOLL. UP WITH PERCENTAGES. BUT FRAMEWORK REALLY TRIES TO ADDRESS THAT CHALLENGE. NOT LIKE THERE'S A GROWING PIE. TOUGH DECISIONS HAVE TO BE MADE. >> I'M NOT GOING TO TALK ABOUT COST SHARING, I DON'T THINK SO. I WANTED TO COMPLIMENT NCI FOR ITS RECENT -- EMPHASIS RECENTLY ON IMPLEMENTATION SCIENCE PARTICULARLY RELATED TO DISADVANTAGED POPULATION, RURAL POPULATIONS, ET CETERA. I WAS WONDERING WHERE YOU SEE THAT IN YOUR AIDS PORTFOLIO. >> THAT'S REALLY GOOD QUESTION. THANK YOU. DISPARATE, CANCER HEALTH DISPARITIES IS HAVING ITS MOMENT CLEARLY. ACR MADE THAT TOPIC OF INTEREST. JUST WRITTEN BUNCH OF NEW SORT OF POSITION PAPERS ON RESEARCH OF CANCER DISPARITIES. WE HAVE ALWAYS HAD LARGE PORTFOLIO. CERTAINLY GROWING. AS YOU ALLUDE -- IF YOU LOOK AT THE DATA ACTUALLY, DELTA IN MORTALITY BETWEEN AFRICAN AMERICAN PATIENTS AND CAUCASIAN PATIENTS THEY'RE BOTH GOING DOWN , DELTA IS GETTING SMALLER. SHRINKING. DISPARATE WITH POSITIVE -- DON'T WANT TO GET RID OF DISPARATE BY THAT. BOTH GOING DOWN, ONE GOING DOWN MORE QUICKLY THAN OTHERS. GOOD NEWS ON OVERALL MORTALITY WITH REGARD TO RACE. IN THE COURSE OF THOSE INVESTIGATIONS WE ALSO LOOK AT OTHER CAUSES OF MORTALITY THOSE DATA FOR NON-CANCER MORTALITY ARE QUITE SHOCKING WHICH RELATE TO THE INCREASE IN PARTICULARLY CAUCASIAN DEATHS IN YOUNG MEN AND YOUNG WOMEN RELATED TO POISONINGS, OPIOIDS AND WHAT NOT I DIGRESS. SINCE THE 1990s. NOT AS QUICKLY AS WE'D LIKE THAT IS SUBSTANTIAL AND LARGE BUT GOING IN THE RIGHT DIRECTION. DISPARATE THAT IS NOT GOING IN THE RIGHT DIRECTION IS RURAL URBAN DISPARATE. N.1990s, RURAL PATIENTS IN THE UNITED STATES WITH CANCER HAD BETTER OUTCOME THAN URBAN PATIENTS. THAT HAS CHANGED DRAMATICALLY THAT DISPARATE IS WIDENING EVERY YEAR FOR REASONS WE DON'T COMPLETELY UNDERSTAND. RURAL IS CONFOUNDED BY RACE, SOCIOECONOMIC STATUS, ACCESS TO CARE, EDUCATION, NUMBER OF THINGS. ALL OF THOSE ARE PLAUSIBLE CAUSES OF DISPARATE. IT'S GETTING WORSE EVERY YEAR. FOR CANCER MORTALITY NOT TO MENTION NON-CANCER MORTALITY. THAT IS AN AREA WHERE WE'RE ISSUING NEW RFAs DEVOTING NEW EMPHASIS. WE HAVE THESE IMMENSE GREAT TOOLS LIKE CYR AND OTHER KINDS OF COMPREHENSIVE DATABASES THAT ARE IDEAL. AS I MENTIONED THOSE THINGS ARE USEFUL FOR ANY AREAS, QUESTIONS LIKE DISPARITIES IN PATIENTS WITH HIV INFECTION. LASTLY I'LL SAY BIG EMPHASIS OF THE NCI WHILE I'M IN CHARGE OF IT FOR THE BRIEF TIME AS PRESIDENTIAL APPOINTMENT. I WILL BE BIG DATA. IN CANCER WE'VE GOT PRETTY GOOD JOB OF AGGREGATING LARGE DATA SETS, MILLIONS OF PATIENTS WITH GENOMICS IDENTIFIED WE'VE SEQUENCED THEIR TUMOR, POINT MUTATIONS. BUT DON'T KNOW VERY MUCH AT ALL ABOUT CLINICAL OUTCOME OF THOSE PATIENTS. GETTING ANNOTATION ON OUR PATIENTS THEN LINKING IT IN WAY THAT RESPECTS PATIENT PRIVACY SOMETHING WE'RE GOING TO SPEND LOT OF TIME AND MONEY TRYING TO MAKE WORK. NO MATTER WHAT YOU'RE INTERESTED IN IN CANCER RESEARCH BIG DATA SETS ARE LINKED ARE USEFUL. FOR EXAMPLE, PROBLEMS LIKE OUTCOMES OF PARENTS WITH HIV WILL BE WELL SERVED. >> DICK, FINAL COMMENT. >> I APOLOGIZE FOR THAT. >> I'M FROM JOHNS HOPKINS. MAKE IT BRIEF I'M INTERESTED IN YOUR PREVIOUS HAT AS CANCER CENTER DIRECTOR AT UNC AND EXPERIENCE IN MALAWI I THINK THAT'S GREAT. I WONDER HOW YOU DID THAT. DID YOU DO THAT WITH HIV DOLLARS , DID YOU DO THAT WITH NON-HIV DOLLARS. >> DOESN'T DESERVE 30 SECOND ANSWER THAT IS 30 MINUTE OVER DRINKS ANSWER HONESTLY. AS YOU PROBABLY KNOW THE MALAWI STARTED AT HIV PROGRAM. MIKE COHEN DOING STUDIES TRYING TO REDUCE SPREAD AMONG PARTNERS. ASTHMA HOWIE DID BETTER JOB OF GETTING EVERYBODY IN THE COUNTRY WHO IS HIV INFECTED ON ANTI- RETRO-VIRALS THE INCIDENTS OF FULL BLOWN AIDS IN MORBIDITY HAS GONE DOWN CANCER IS BECOMING BIGGER PROBLEM. PARTICULARLY CANCER IN YOUNG PEOPLE LIKE AVERAGE AGE, ESOPHAGEAL CANCER, HIGHLY DEADLY MALIGNANCY MAINLY WE IS SEEN IN 30-YEAR-OLDS, 30, 40, 50 -YEAR-OLD. THE CANCER BURDEN THERE LOT OF LYMPHOMA, LOT OF BURKITT'S, HODGKIN'S DISEASE AND HIV ASSOCIATED MALIGNANCIES. IT'S REALLY INTERESTING POPULATION TO DO BASIC CANCER -- TRANSLATIONAL CANCER RESEARCH. BUT FUNDING THAT IS ANOTHER KETTLE OF FISH. WE DIDN'T REALLY -- THERE WERE SOME NCI GRANTS THAT FUND INTERNATIONAL ACTIVITIES, THOSE TEND TO BE SMALL, THEY STILL EXIST I SHOWED THE ONE WE TALKED ABOUT. THERE'S SOME PROBLEM OF THE OFF SITE GETTING LOWER INDIRECT RATE , THAT IS HASSLE. THEN I DID LOT OF TIME AS CANCER DIRECTOR TRYING TO DO PHILANTHROPY FOR RESEARCH IN MALAWI. I'D SAY 99% OF DONORS THEIR EYES QUICKLY ROLLED BACK WHEN YOU START TALKING ABOUT GLOBAL ONCOLOGY BUT 1%, THE BILL GATES OF THE WORLD WHO REALLY GET THIS AND WANT TO PROVIDE FUNDING AND OFTEN THOSE PEOPLE ARE SIGNIFICANT MEANS. WE'VE BEEN TRYING TO GET INDUSTRY INVOLVED. THEY GOT A BLACK EYE BECAUSE OF CULTURAL SENSITIVITY IN THE PAST THEIR INTEREST WAS TEPID, BUT GROWING I THINK ESPECIALLY WHEN YOU TALK ABOUT DOING THING LIKE CHECKPOINT INHIBITOR TRIAL IN HODGKIN'S DISEASE YOU WANT DO THAT IN UNITED STATES FOR VARIETY OF REASONS BUT YOU CAN DO IT IN MALAWI AND INDUCTION THERAPY IS NOT SO STRAIGHT FORWARD BECAUSE OF THE TOXICITY. IT'S VERY CHALLENGING. I FELT LIKE THAT WAS ONE OF THE BEST THINGS THAT MY CANCER CENTER SUPPORTED. IT WAS PHENOMENALLY INTERESTING SCIENTIFICALLY, JUST FELT LIKE YOU WERE DOING A GOOD THING WHEN YOU VISITED THERE AS A HUMAN BEING. BUT I WORRIED A LOT ABOUT IT. SORT OF ONE BAD BUDGET YEAR THE WHOLE THING WAS A PROBLEM. NO MATTER WHAT WENT OVER THERE, MID STUDENTS, WHATEVER, FOUND SOMETHING TO DO. OWE USED LABOR FORCE VERY EFFECTIVELY. NOW IT'S INTERESTING AS NCI DIRECTOR IF I BELIEVE IN THAT CLEARLY I DO WHY CAN'T WE USE MORE FEDERAL FUNDS FOR RESEARCH THAT HAVE TYPE. THAT'S A VERY TOUGH QUESTION. THERE IS SOMETHING FOR THE NCI IN GLOBAL ONCOLOGY RESEARCH. IT'S AN IMPORTANT PART OF OUR MISSION BUT OF COURSE WE ALWAYS HAVE TO ANSWER TO CONGRESS WHAT'S IN IT FOR THE AMERICAN TAXPAYER. >> GOING TO STOP BECAUSE WE HAVE NOW A 20-MINUTE BREAK. WE'LL START PROMPTLY AT 2:45 KEEP OURSELVES ON TIME FOR FLIGHTS. WE'LL HAVE MORE TIME FOR DISCUSSION, THANK YOU SO MUCH. >> THANKS FOR THE OPPORTUNITY. I HAVE TO DASH OUT. >> THANK YOU. THE NEXT -- ONE REMINDER, PLEASE TAKE OUT YOUR CONFLICT OF INTEREST FORM AND PLEASE SIGN IT AND GIVE IT TO ELIZABETH CHURCH HERE OR PIPER OUTSIDE PLEASE. UPDATES ON RESEARCH ACTIVITIES WE'RE NEXT GOING TO HEAR FROM FRANZISKA B. GRIEDER. WHO IS THE DIRECTOR OF THE ORIP WHICH STAND FOR THE OFFICE OF RESEARCH INFRASTRUCTURE PROGRAM. AT THE NIH. DR. GRIEDER JOIN THE NIH IN 2000 IS NOW DIRECTOR OF THE OFFICE OF RESEARCH INFRASTRUCTURE PROGRAMS WITHIN DIVISION OF PROGRAM COORDINATION, PLANNING AND STRATEGIC INITIATIVES WHICH ALSO HAS ACRONYM. ORIP SUPPORTS RESEARCH INFRASTRUCTURE AND RELATED RESEARCH PROGRAMS BY FUNDING ANIMAL MODEL PROGRAMS, RESEARCH TRAINING OPPORTUNITIES FOR VETERINARY SCIENTISTS AND CONSTRUCTION ALSO THE SHARED INSTRUMENT PROGRAM. SHE ALSO IS ADJUNCT FACULTY AT THE SERVICES IN BETHESDA, MARYLAND. THANK YOU. IT'S A PLEASURE TO BE HERE TODAY SHARE WITH YOU A LITTLE BIT ABOUT OUR INTER-ACT BETWEEN ORIP AND O.A.R. AS YOU WILL SEE THAT INTER- ACTION ACTUALLY HAS BEEN GOING ON FOR QUITE AWHILE. ORIP OR THE OFFICE OF RESEARCH INFRASTRUCTURE PROGRAMS WAS ACTUALLY FOUNDED IN DECEMBER OF 2011. THAT DATE IS THE BIRTHDAY FOR OTHER NIH ENTITY THAT WILL BE NC ATS BY ME TELLING YOU THAT NCA TS AND WE WERE FOUNDED OR FUNDED AT THE SAME TIME YOU MAY RECALL THAT THERE USED TO BE ENTITY CALLED NCRR. THAT TOOK DIVISION POINT BIGGER PART BECAME NCATS SO OTHER PARTS WENT OTHER PLACES THEN WE BECAME ORIP OR OFFICE OF RESEARCH INFRASTRUCTURE PROGRAMS. WE LIKE TO USE SHORT DESCRIPTION FOR OUR MISSION AS INFRASTRUCTURE FOR INNOVATION. OUR GOALS OR OUR PROGRAMS ARE BEST DESCRIBED BY THE TWO DIVISIONS WHICH YOU ALREADY HEARD IS DIVISION OF CONSTRUCTION AND PRESIDENT TRUMP THAT'S PRETTY STRAIGHT FORWARD DOES EXACTLY WHAT IT DOES. THEN DIVISION OF COMPARATIVE MEDICINE WHICH FOCUSES ON ANIMAL MODELS FOR BIOMEDICAL RESEARH AND TRAINING FOR NET THEY'RIANS. COUPLE OF YEARS AGO WE PUBLISHED OUR FIRST STRATEGIC PLAN. I SHAMELESSLY PUT COUPLE BACK THERE IN THE CORNER SOMEBODY IS INTERESTED. OUR STRATEGIC PLAN OF COURSE FOCUSES ON TOPICS THAT ARE IN OUR MISSION. THEY FOCUS ON TRANS-NIH ACTIVITIES. ON PRECISION AND REPRODUCIBILITY ONE OF THOSE WORDS THAT IS USED VERY HEAVILY THAT'S OF HIGH IMPORTANCE TO NIH. AND SHARED RESOURCES. A LITTLE BIT MORE BECAUSE WE FUND THE PROGRAM OF THE NATIONAL PRIMATE RESEARCH CENTERS WHERE WE HAVE LOTS AND LOTS OF INTER- ACTIONS WITH O.A.R. THE NNPRC, NATIONAL PRIMATE RESEARCH CENTERS ARE SOME OF THE LONGEST FUNDED PROGRAMS WITHIN NIH I'LL TELL YOU A LITTLE BIT MORE ABOUT THEM. THOSE GRANTS ARE 55 YEARS OLD. NOT MANY OTHER GRANTS THAT HAVE BEEN FUNDED CONTINUOUSLY FOR THAT AMOUNT OF TIME. OF COURSE THE REASON WHY I'M STRESSING THE NPRC IS THAT FOR HIV RESEARCH IS A LOT OF NEED. THAT'S WHERE ONE OF THE BIG INTER-ACTIONS BETWEEN O.A.R. AND PROGRAMS WE OVERSEE. COMES ALONG. I'M NOT GOING TO TALK ABOUT BECAUSE I REALLY CAN'T SAY THAT MUCH ABOUT IT. IT'S A FAULT THAT WAS FUNDED WITH O.A.R. MONEY AT DUKE AND IT FOCUSES ON MANUFACTURING OF VACCINES. VERY LAST SLIDE IN YOUR HAND OUT TALKS A LITTLE BIT ABOUT IT BUT IT WAS ONLY FUNDED LAST YEAR SO THERE'S NOT MUCH UPDATES TO BE GIVEN. HOWEVER, I WILL TALK ABOUT THE THREE OTHER TOPICS, SHARE WITH YOU ABOUT NONHUMAN PRIMATE THAT WE SUPPORT AND USED BY O.A.R. INVESTIGATORS. TALK ABOUT SOMETHING VERY NEW THAT'S ACTUALLY SO NEW THAT IT'S ONLY POSTED BUT NO APPLICATION HAS BEEN RECEIVED. THEN THE O.A.R. KO1 VACCINE SCHOLARS PROGRAM. LET ME START WITH THE PRIMATES. I TOLD YOU THAT WE FUND THE NATIONAL PRIMATE RESEARCH CENTERS IT'S A CONSORTIUM THERE ARE SEVEN SITES. THEY ARE LISTED ON THIS MAP AND YOU SEE MOVING FROM EAST TO WEST THERE IS ONE CENTER AT EMORY, ONE AT UNIVERSITY OF WISCONSIN IN MADISON, AT TULANE UNIVERSITY , AT TEXAS, SOUTHWEST FOUNDATION AND THREE CENTERS AT WEST COAST AT UC DAVIS IN CALIFORNIA, AT OREGON HEALTH SCIENCE CENTER THEN WASHINGTON. SEVEN CENTERS ARE OF COURSE HUGE CENTERS THAT WORK TOGETHER AS I TOLD YOU IN CONSORTIUM. THE CONSORTIUM OF COURSE DOES MUCH, MUCH MORE THAN JUST BREED ING MONKEYS. WHAT DO THEY DO. THEY FUND, SUPPORT, MAKE IT POSSIBLE FOR OVER A THOUSAND FUNDED NIH FUNDED PROJECTS TO HAVE NONHUMAN PRIMATES FOR THEIR RESEARCH. THEY CONDUCT OVER -- THERE ARE OVER 2,000 SCIENTISTS ENGAGED IN RESEARCH. THERE ARE OVER 20,000 ANIMALS INVOLVED IN THOSE SEVEN SITES. YOU CAN SEE QUITE A VOLUME. IT'S QUITE A BUDGET, TOO. THE 20,000 ANIMALS ARE IN ABOUT EIGHT DIFFERENT SPECIES, DEPENDS HOW ONE COUNTS. OF COURSE FOUR OF THEM ARE OF MOST INTERET FOR HIV/AIDS RESEARCH. THAT WOULD BE ON THE TOP RECESS MCCOOK. THE BIG TAIL IS ONE IN THE MIDDLE ON THE BOTTOM. SOTTY MANGABEY ON THE LEFT THEN THE CYNOMOLGUS IS ON THE THREE SIDE. USED FOR DIFFERENT ASPECTS OF HIV RESEARCH, FOR EXAMPLE, THE C YNOMOLGU ARE USED -- RELATIVELY HOMOGENEOUS GENETICALLY THERE IS LESS DIVERSITY. SOME OF THE OTHER SPECIES ARE USED FOR SPECIFIC TRANSMISSION PATHWAYS OR FOR SPECIFIC VACCINES INVESTIGATION. AS I MENTIONED PREVIOUSLY, NPRC OR NATIONAL PRIMATE RESEARCH CENTERS ARE NOT JUST MONKEY- BREEDING FACILITIES BUT THEY ALSO PROVIDE THE INVESTIGATORS WITH TOOLS AND TECHNIQUES, WITH EXPERTISE AND RIGHT ANIMAL CARE THAT'S NEEDED. IN MANY CASES INVESTIGATORS DON'T HAVE THE FACILITIES AT THEIR SITES THEY RELY ON EXPERIMENTS ACTUALLY BEING CONDUCTED AT THE PRIMATE CENTERS THE NPRCs ARE FUNDED ON THE MECHANISM. IF YOU ARE NIH YOU LOVE MECHANISM THINGS. THEY ARE ONLY USED BY PRIMATE CENTERS WE ARE THE ONLY ONES WHO USE THIS MECHANISM. WE ARE NIH INSIDER, THE P TELLS YOU THAT THEY ARE GRADES, THEY NORMALLY DON'T FORM CONSORTIA WHEN YOU HAVE Ps. ABOUT TEN IS PROBABLY ABOUT RIGHT. TEN YEARS AGO WE TALKED THEM INTO ACTUALLY FORMING A CONSORTIUM AND THAT'S WHY THEY HAVE WEBSITE AMONGST THE SEVEN CENTERS. WE WORK VERY CLOSELY WITH THE SEVEN CENTERS. WE PROVIDE FUNDS FOR THEM IN THE CONSORTIUM NETWORK TO HAVE COORDINATOR AMONG THE MEMBERS TO FORM SUBCOMMITTEES WHICH ARE -- WHICH ALL MEMBERS PARTICIPATE IN TO COORDINATE THEIR EFFORTS IN BREEDING ANIMALS IN GENETIC ANIMALS IN PATHOLOGY, THERE ARE ABOUT 11 OF THEM. THIS EFFORT HAS REALLY STREAMLINED AND HELPED THE COHESIVENESS OF THE PROGRAM AND PROGRAM TO BE USEFUL TO INVESTIGATORS. IF YOU HAPPEN TO GO TO THESE WEBSITES AND YOU LOOK AROUND, YOU CAN FIND TWO THINGS WHICH I FIND INCREDIBLY HELPFUL TO INVESTIGATORS. FIRST IS LIST OF AREAS OF EXPERTISE. YOU SEE THE SEVEN LISTED ON THE RIGHT SIDE. THE NUMBER ONE IS MAJOR PRIORITY , NUMBER TWO IS MINOR PRIORITY THEY ANNOUNCED TWO RESEARCHERS WERE -- IF YOU ARE INTERESTED IN THIS AREAS I CAN THERE'S IMMUNOLOGY ANDTISE.- INFECTIOUS DISEASE CATEGORY WITH A LITTLE ARROW IF YOU EXPAND THAT THAT WOULD SEE HIV/AIDS. SECOND SUCH SITE GIVES YOU TOOLS AND TECHNOLOGIES AND FACILITIES THAT THE CENTER PROVIDE FOR INVESTIGATORS. SAME SET UP AS BEFORE, THE SEVEN CENTERS, ONE AND TWO AND A LIST ING OF AREAS OF -- THAT THEY PROVIDE SUPPORT FOR AND INVESTIGATORS CAN USE. WITH THAT R THAT I'M MOVING OVER TO A LITTLE BIT DIFFERENT BUT RELATED TOPIC ON NONHUMAN PRIMATES THAT'S THE SPF OR SPECIFIC PATHOGEN FREE COLONIES. OF COURSE THOSE ARE OF PARTICULAR INTEREST TO HIV AND AIDS RESEARCHERS AS WELL. WITH O.A.R.'S HELP OR IF -- FUNDS 11 SUCH COLONIES. THEY ARE LOCATED AT EIGHT DIFFERENT LOCATIONS. SIX LOCATIONS ARE AT THE NATIONAL PRIMATE RESEARCH CENTERS WHICH I JUST DESCRIBED TO YOU SO THAT WOULD BE THE FIRST SIX LISTED. THERE ARE ADDITIONAL TWO, ONE AT HOPKINS UP THE STREET THEN ONE AT THE CARIBBEAN PRIMATE CENTER. AS YOU CAN SEE SOME OF THEM HAVE TWO SUCH COLONIES, I LISTED THEMED FOR YOU, MOST OF THEM ARE SPECIFIC PATHOGEN FREE FOR FOUR VIRUSES, THOSE WOULD BE HIV, TWO RETRO-VIRUSES LISTED THEN OF COURSE HERPES B. THEN THEY ARE AT THE ADVANCED OR ENHANCED EXPANDED SPF COLONIES THOSE ARE LISTED AS WELL ON THE SLIDE FOR YOU. MOST OF THESE COLONIES ARE RHESU S, TWO ARE PIG TAILS AS YOU CAN SEE ON THE SLIDE. WHAT THIS SLIDE ON TOP OF -- SHY ADD ONE MORE PIECE OF INFORMATION. AMONGST THE 11 COLONIES THERE ARE -- THEY HAVE ABOUT 7-- ANIMALS THAT BECOME AVAILABLE IS A LITTLE BIT SMALLER THAN 7,000 IT TAKES ABOUT THREE YEARS FOR ANIMALS TO MATURE BE USED BY INVESTIGATORS. THERE IS CURRENTLY BIG DEMAND ON SPF ANIMALS THAT THERE IS SUPPLY IT'S ALWAYS VERY CHALLENGING FOR THE BREEDERS FOR GRANTEES TO KIND OF KNOW HOW MANY ANIMALS TO BREED BECAUSE DON'T WANT TO INVEST THREE YEARS INTO BREEDING ANIMALS, A LITTLE BIT EASIER IF YOU HAVE MICE OR FOR THAT MATTER FISH, IT GOES A LITTLE BIT FASTER AND QUICKER. I TOLD YOU IN ADDITION TO THE NP RC'S, SOME PRIMATE FACILITIES WE HAVE, WE FUND. TWO ARE LISTED HERE. ONE THAT I WANT TO DRAW YOUR ATTENTION TO IS THE CARIBBEAN PRIMATE CENTER. BECAUSE THAT'S NEXT TOPIC I'M GOING TO TALK ABOUT. THE CARIBBEAN PRIMATE CENTER IS LOCATED ON PUERTO RICO OR IN PUERTO RICO ON THE ISLAND. THEY HAVE A HUGE, AS I JUST TOLD YOU SPF COLONY ACTUALLY, THEY SUPPLY A LOT OF THE ANIMALS. THEY ARE ONE OF THE STRONGEST COLONY, THEY HAVE OVER 2,000 ANIMALS. I LIST FOR YOU WHAT RESEARCH AREAS ARE, WHAT YOU KIND OF WOULD EXPECT LIKE STRATEGIES, PRECLINICAL SAFETY TESTING, SOME IMMUNE INVESTIGATION, PASSIVE IMMUNITY. RECTAL TRANSMISSION AND PROTECTIVE CELLS. UNIQUE SETTING IN PUERTO RICO OF THIS ISLAND CALLED CAYO SANTIAGO IS OF SPECIFIC INTEREST BECAUSE THERE IS FREE RANGING COLONY ON CAYO. THAT COLONY WAS ACTUALLY STARTED WITH ABOUT 400 ANIMALS. 400 ANIMALS THAT ARE OF INDIAN ORIGIN WITH VERY LITTLE INBREED ING FROM OTHER SOURCES. SORRY ABOUT THAT. I USUALLY HAVE SUCH A LOUD VOICE THAT NOBODY EVER COMPLAINS TO ME I WILL TRY TO DO A LITTLE BIT BETTER. THAT COLONY OF SPECIFIC INTEREST TO INVESTIGATORS BOTH HIV INVESTIGATORS AND NON-HIV INVESTIGATORS. LET ME SHOW YOU HOW THAT SETTING AT THE CARIBBEAN PRIMATE CENTER LOOKS LIKE. YOU SEE THE ISLAND. CLOSE TO THAT YOU SEE FIELD STATION WITH THE CORRALS, WHERE MANY OF THE ANIMALS SPECIFICALLY SPF COLONIES ARE HOUSED. YOU SEE RESEARCH LABS AND MAIN FACILITY, INDOOR FACILITY THEN IN THE RIGHT LOWER CORNER YOU SEE CAYO SANTIAGO. YOU SEE THE ISLAND, IF I HAD A POINTER -- I DO, HERE IS THE ISLAND I WANT TO POINT THIS OUT TO YOU THEN HERE IS LITTLE CAYO AND ITHSMU, IS THAT CONNECTS THE TWO. IT WILL BECOME CLEAR IN JUST A MINUTE. THAT IS THE SETTING WHICH THE ANIMALS, THE 400 ANIMALS START ING NOW OVER COUPLE THOUSAND THEY ARE FREE RANGING ON THE ISLAND, THEIR CARETAKERS AND VETERINARIANS GO OUT WITH BOATS AND TAKE CARE OF THEM. OF COURSE BREEDING AND HABITATS ARE VERY EASY TO MAINTAIN OUT THERE. THEN SEPTEMBER 17TH -- SEPTEMBER 20TH, 2017 HAPPENED. AS YOU CAN SEE FROM THESE SLIDES THE OUTLINE OF PUERTO RICO AND THE EYE OF THE HURRICANE JUST MOVED RIGHT ACROSS THE ISLAND. AS YOU CAN SEE IT MOVED RIGHT ACROSS WHERE CAYO SANTIAGO. IT MOVED RIGHT ACROSS IT. MAUREEN AND I WERE ON TELEPHONE CONFERENCE CALLS AFTER SEPTEMBER 20TH, IT WAS REALLY QUITE DEVASTATING WHAT HAD HAPPENED. LET ME SHOW YOU THIS ONE SIDE. I COULD SHOW YOU SLIDES AND SLIDES WHAT HAD HAPPENED. I THINK THIS SLIDE ACTUALLY MAKES THE POINT QUITE CLEARLY. HERE ON THE LEFT SIDE YOU SEE WHAT I POINTED OUT TO YOU ON THE PREVIOUS SLIDE. LITTLE ITHMUS FROM BIG TO THE SMALL ISLAND WERE WHERE CARETAKERS AND ANIMALS HAVE PASSED BETWEEN THE TWO PLACES WHERE FOOD WAS CARRIED OVER. THIS IS POST HURRICANE. THIS IS POST HURRICANE THE ITHSM US IS GONE, BRIDGE IS GONE, IT'S JUST NOT THERE ANY MORE. THAT'S JUST ONE REFLECTION OF HOW DEVASTATING THE HURRICANE WAS. THE SURPRISING ISSUE WAS THAT VERY, VERY FEW ANIMALS WERE ACTUALLY LOST. IT WAS AMAZING HOW THE ANIMALS JUST HID AND HUDDLED UP DID THE BEST THEY COULD. COUPLE OF WEEKS BEFORE IN THE " WASHINGTON POST," MARK TRAIL -- SORRY ABOUT THIS -- PICKED THAT UP SO I CAN PASS THIS AROUND. IT WAS PICKED UP THAT THE ANIMALS ACTUALLY ARE NOT DOING SO BADLY, VEGETATION IS WIPED OUT. BUT SIGN FISTS ARE REALLY STEPPING UP TO THE PLATE AND HELPING THE ANIMALS IN PUERTO RICO AND CAYO SANTIAGO OUT, I THOUGHT THAT WAS PRETTY FUNNY. I NOT I WOULD SHARE THAT WITH YOU. ANYWAY, MAUREEN AND I AND LOTS OF OTHER PEOPLE, JUST CALLING OUT MAUREEN BECAUSE IT'S EASIER FOR ME TO DO IT THAT WAY. WORKED VERY HARD STEPPED UP TO THE PLATE TO HELP THEM OUT. AND WROTE FUNDING OPPORTUNITY ANNOUNCEMENT FOR CO6 THAT WILL BE CONSTRUCTION RENOVATION GRANT TO LIMIT -- MORE LIMITED APPLICATIONS TO COME FIN PUERTO RICO ONLY TO REBUILD FACILITIES AND RENOVATE AND UPDATE DESTROYED INFRASTRUCTURE. LOTS OF THE WATER SUPPLIES, LOTS OF THE POWER SUPPLIES THEY WERE JUST DESTROYED. THE CO6 WAS PUBLISHED ON MARCH 1 WE EXPECT APPLICATIONS, WE EXPECT TWO TO COME IN BY END OF NEXT MONTH, THAT WOULD BE VERY SOON IN GRANT TERMS. HAVE TO WRITE APPLICATIONS FOR RENOVATION AND IMPROVEMENT, RE STORAGE OF THE PHYSICAL INFRASTRUCTURE AND WE HOPE TO FUND THE APPLICATION O.A.R. FUNDS BY THE END OF THE CURRENT FISCAL YEAR. WE HAVE A LITTLE BIT OF WORK AHEAD OF US BUT I'M VERY CONFIDENT THAT RECEIVE COMPETITIVE APPLICATIONS THAT WE ACTUALLY CAN DO IT. WITH THAT, LET ME MOVE TO MY LAST TOPIC BECAUSE I SEE THAT THE TIME IS MOVING ON QUITE QUICKLY. LAST TOPIC IS THE O.A.R.-ORIP SUPPORTED SCOTT WAR. IN ORDER TO INSURE HIGHLY TRAINED INVESTIGATORS WHO WORK ON ANIMALS -- ANIMAL MODELS, PRE CLINICAL TOPICS WITH TOPICS IN HIV VACCINES. THIS PROGRAM WAS STARTED ABOUT -- WELL ACTUALLY FIRST IDEAS WERE ABOUT THREE AND A HALF YEARS AGO LOTS OF SMART PEOPLE SPEND LOT OF HOURS DISCUSSING OPTIONS AND OUTCOME WAS A KO1 MENTORED RESEARCH SCIENTIST AWARD PROGRAM THAT WAS FUNDED COUPLE OF YEARS AGO FOR THE FIRST TIME, RECEIVED APPLICATIONS 17 FUNDING, THE '18 FUNDING APPLICATIONS WERE RECEIVED EARLIER IN THE YEAR WERE ACTUALLY REVIEWED LAST WEEK IN RESPONSE TO THE CURRENT FUND ING OPPORTUNITY ANNOUNCEMENT THAT I SHOW YOU HERE I CAN TELL YOU THAT WE HAVE SIX SCHOLARS FUNDED CURRENTLY FUNDED. WE HOPE THAT WE CAN ADD A FEW MORE OUT OF THESE LATEST CROP OF APPLICATIONS. OF COURSE HAVE JUST BEEN REVIEWED. VERY POSITIVE ASPECT THAT GOES ALONG WITH THE SCHOLARS PROGRAM IS ACTUALLY A CONFERENCE EVENT THAT'S FUNDED BY OUR GRANT. SCHOLARS COME TOGETHER WITH THEIR MENTORS WITH OTHER SCHOLARS, YOUNG EARLY STAGE INVESTIGATORS COME TOGETHER, EXCHANGE THEIR IDEAS, THEIR RESEARCH AND DISCUSS IT. THE NEXT CONFERENCE, FIRST ONE WAS A YEAR AGO, NEXT ONE IS IN MAY. I'M VERY EXCITED ABOUT THIS PROGRAM AS A MATTER OF FACT THINK THIS WILL REALLY ENHANCE YOUNG SCIENTISTS IN HIV/AIDS RESEARCH GOING INTO PRECLINICAL- CLINICAL DIRECTION. WITH THAT I WILL CLOSE JUST SAY THAT IN MY OPINION ORIP AND O.A.R. HAVE ENJOYED AN INCREDIBLY PRODUCTIVE PARTNERSHIP. WE HAVE HAD MANY CHALLENGES, HAVE ALWAYS COME OUT WITH GOOD SOLUTIONS. I AM CONVINCED AS I HAVE SAID MANY TIMES THAT THERE ARE MORE CHALLENGES WE CAN FACE, FEWER ANSWERS THAN WE HAVE QUESTIONS BUT IN THE END WE WILL ADJUST TO WHATEVER IS NEEDED HOWEVER WE CAN ADDRESS THE NEEDS FOR THE NEEDS OF THE SCIENTISTS WITH THAT I'M HAPPY TO ANSWER ANY QUESTIONS IF THERE SHOULD BE ANY >> GREAT. WE'RE OPEN FOR DISCUSSION. I JUST HAD A QUESTION BECAUSE -- IN YOUR INTRODUCTION TALKED ABOUT THE FUNDING OF VETERINARY SCIENTISTS IS THIS KO1 OPEN FOR VARIETY OF SCIENTISTS? >> APPLICANTS CAN HAVE VARIETY OF DEGREES THE CURRENT CADRE I DID ASK SPECIFICALLY ARE ALL Ph Ds IN THE NEW U.S. U.S. GROUP WE HAVE APPLICANTS WHO HAVE DVMs I WAS HOPING TO GET SOME MDs IN THERE TO GO MORE INTO THE PRECLINICAL-CLINICAL ARENA WE'LL JUST HAVE TO SEE WHAT APPLICATIONS WE CAN -- IT'S DEFINITELY OPEN TO EVERYBODY. IT'S A LITTLE BIT LIMITED IN HOW MANY YEARS POST YOUR FINAL DEGREE YOU CAN BE ABOUT TEN-YEAR WINDOW. BECAUSE IT IS TARGETED FOR EARLY STAGE INVESTIGATORS. >> PLEASE, BRUCE. >> IS THERE A REASON WHY IT'S ONLY THREE YEARS GIVEN I THINK MOST OTHER KSR TIME TO MAKE THAT TRANSITION TO RO1 GETTING LONGER >> THE DECISION TO FUND THREE YEARS WAS MADE BASED ON FUNDING DECISIONS, WAS MADE BASED ON WHERE THESE PEOPLE ARE IN THEIR STAGE OF TRAINING THAT THE THREE YEARS WAS FELT TO BE LIKE THE RIGHT TIME. BECAUSE AS MENTORED KO1 GRANTEE INVESTIGATORS YOU ACTUALLY RECEIVE MOST OF YOUR SALARY NOT REALLY ANY OTHER SUPPORT THAT YOU RECEIVE. WE NEED TO RECEIVE THE FUNDING FOR THE RESEARCH MOSTLY FROM OTHER SOURCES, FROM YOUR MENTOR FROM OTHERS. >> LIZ. >> THE NONHUMAN PRIMATE RESOURCES, I KNOW THAT ZICA RESEARCH HAS PUT SOME INCREASED DEMAND FOR ANIMALS FOR STUDY. I'M WONDERING IF THERE'S BEEN AN INCREASE IN FUNDING FOR THE CENTERS TO COMPENSATE FOR THAT. >> SO, YES, WE HAD OF COURSE QUITE AN UPTICK IN REQUESTS FOR ZIKA. WE HAD AN UPTICK IN REQUEST FOR PREGNANT ANIMALS. I FEEL THAT I'M A LITTLE BIT LOW ON THE PECKING ORDER TO TALK ABOUT FUNDING. I'M VERY HAPPY TO SPEND WHAT I'M GIVEN. I ALWAYS ASK FOR MORE. THE BUDGETS ARE -- THIS YEAR WE JUST GOT OUR BUDGET THIS YEAR SO WE ALWAYS MAKE STRATEGIC DECISIONS. BY THE WAY IT'S INTERESTING, YOU GUYS ARE THE COUNCIL FOR O.A.R. OUR COUNCIL IS ACTUALLY THE COUNCIL OF COUNCILS THAT'S WHERE WE WOULD BRING ANY REQUESTS FOR FUTURE FUNDING ANNOUNCEMENTS OR FUTURE DIRECTION. >> CARL. >> TO THE CONTINUE THE MARCH OF ADDITIONAL DISEASES FOR THE CENTERS TO BE CONSIDERING, TUBERCULOSIS IS ONE AS ANIMAL MODEL TB IS BECOMING, A VERY IMPORTANT MODEL. HOWEVER, NO CENTER WANTS TB INFECTED ANIMALS WITHIN IT. WHAT ARE YOUR PLANS BECAUSE THERE'S THIS PUSH FOR EXPANSION OF TB FACILITIES. ADDITIONALLY THERE'S NEED FOR PET AND OTHER ANCILLARY EQUIPMENT TO GO WITH THIS. HOW CAN WE GO ABOUT ACHIEVING THIS, IT'S NOT JUST ZIKA BUT THERE IS THIS REAL PUSH TO USE NONHUMAN PRIMATE MODEL. >> OF COURSE THERE'S ALWAYS A GREAT NEED FOR NONHUMAN PRIMATES I MIGHT HAVE OVER SOLD A LITTLE BIT SAYING LIKE, HIV/AIDS, HIV/AIDS, BUT I FIGURED THAT WAS MY MISSION HERE. BIG PART OF THE 20,000 ANIMALS ARE GOING FOR HIV RESEARCH, BY THE WAY. BUT, YES, THERE IS NEUROSCIENCE, THERE IS REPRODUCTIVE QUESTIONS, LOTS OF OTHER INFECTIOUS DISEASES PUTTING ON MY INFECTIOUS DISEASE HAT THAT NEEDS TO BE ADDRESSED. TB IS ONE OF THE CHALLENGING ONES AS ANYBODY WHO HAS EVER SEEN OR ENTERED PRIMATE FACILITY YOU NEED TB TEST, MEASLES TEST, TO ENTER FACILITY SO NOBODY WANTS TB TO BE STUDIED. THERE ARE SOME STUDIES GOING ON. THERE ARE SOME STUDIES GOING ON TO DEVELOP BETTER DIAGNOSTIC TESTS. BUT OF COURSE THAT'S ALL VERY ISOLATED. MAYBE THE ISLAND WILL BE -- MAYBE A LITTLE CAYO WE DON'T HAVE THE ISTHMUS ANY MORE. YOU ADDRESS VERY CHALLENGING ISSUE. YOUR LAST POINT WAS LIKE MANY OTHER INFECTIOUS DISEASES OF COURSE, ABSOLUTELY. >> I HAD QUESTION ABOUT THE SHARED INSTRUMENT PROGRAM. BECAUSE I THINK IF YOU THINK ABOUT TYPICAL RO1 FUNDING YOU CAN'T PURCHASE EQUIPMENT. YOU CAN DO THINGS LIKE LEASE EQUIPMENT BUT NOT PURCHASE IT OUTRIGHT. THIS IS A GREAT PROGRAM THAT YOU HAVE TO SHARE INSTRUMENTS ACROSS THE CAMPUS. IT SEEMS IT'S SORT OF A LIMITED -- IT COMES OUT WHEN IT COMES OUT MEANING IS IT ONGOING ROLLING SUBMISSION PROCESS THAT EVERYONE CAN PUT IN SHARED INSTRUMENT GRANT OR ONLY AT TIMES WHEN YOU HAVE FUNDING CAN PUT IT TOWARDS THESE LARGE INSTRUMENTS. >> IT'S AN ANNUAL PROGRAM. ANNOUNCEMENT COMES OUT ONCE A YEAR AND WE AWARD GRANTS THROUGHOUT THAT FISCAL YEAR. THERE ARE TWO PROGRAMS. WE HAVE TO SHARED INSTRUMENTATION PROGRAM THAT GOES UP TO 500K. THEN 500K TO TWO MILLION THAT'S HIGH END INSTRUMENTATION PROGRAM WHY DID WE DO THIS? WELL IT'S A LONG STORY. THAT'S JUST HOW IT WAS SPLIT OVER THE YEARS. THERE IS ONE APPLICATION DEADLINE, ONE ANNOUNCEMENT THAT COMES OUT THOSE PROGRAMS THAT ARE BEING FUNDED. I'LL GIVE YOU A LITTLE BIT MORE INFORMATION FOR THOSE WHO DON'T KNOW IT'S ACTUALLY SHARED INSTRUMENTS ARE FUNDED UNDER S10 PROGRAM UNDER S20 MECHANISM THAT MAKES IT EASIER FOR TO YOU SEARCH. ABOUT 66 MILLION WE FUND ABOUT QUARTER OF THE APPLICATIONS THAT WE RECEIVE. WE GET ABOUT 400 CAN FUND ABOUT A HUNDRED. >> I HAVE ONE MORE THING. BECAUSE I THINK IT'S ACTUALLY NOT WELL ENOUGH KNOWN, YOU PUT IN APPLICATION FOR THOSE WHO DON'T KNOW YOU HAVE TO HAVE THREE NIH FUNDED GRANTS THAT CAN USE THE INSTRUMENT THAT YOU APPLY FOR. MOST APPLICATIONS THAT ARE FUNDED HAVE AT LEAST EIGHT NIH FUNDED GRANTS. THERE IS ALSO SOME CONSIDERATION GIVEN IMPLEMENTED TO MAYBE MAKE SOME DIFFERENCES BETWEEN IDEA STATES, NOT SO WELL FUNDED AREAS THAN BETTER FUNDED AREAS. >> THERESA. >> I'M FROM TEMPLE OF THE. I PUT IN ONE OF THE S10 GRANTS, MY QUESTION IS, HAVE YOU THOUGHT ABOUT DOING IT MORE THAN ANNUALLY? BECAUSE YOU HAVE TO -- YOU GET COMMENTS, YOU GET A SCORE THEN RESUBMIT. IF IT'S ON ANNUAL BASIS IT SEEMS FOR INSTRUMENT PURPOSE THEN IT COULD BE LIKE ALMOST TWO YEARS BEFORE YOU GET THAT. FOR ME I THINK WE HAD TO GO FIND OTHER SOURCES OF FUNDING BECAUSE IT'S JUST -- DON'T WANT TO WAIT TWO YEARS TO GET THE MACHINE. CAN YOU JUST COMMENT ON THAT? >> THAT'S VERY INTERESTING QUESTION. THE HIGH END I TOLD YOU ABOUT SHARED INSTRUMENT AND HIGH END. HIGH END USED TO BE EVERY OTHER YEAR. THEN WHEN I CAME ALONG I COULDN'T REALLY UNDERSTAND WHY THAT WOULD BE GOOD IDEA IT HAD TO DO WITH THIS SPLIT APPROACH OF FUNDING, HALF IN ONE YEAR, HALF IN THE OTHER YEAR, JUST DIDN'T MAKE SENSE TO ME. WE ACTUALLY CHANGED IT TO ANNUAL COULD WE EVER CHANGE IT TO A MORE FREQUENT CYCLE, OF COURSE THAT WOULD MEAN THAT WE HAVE FEWER APPLICATIONS IN EACH CYCLE , FEWER APPLICATIONS, KEEP IN MIND THESE ARE APPLICATIONS SEQUENCING, THAT ARE FACTS THAT ARE YOU NAME IT. THERE'S LOTS OF DIFFERENT APPLICATIONS. I THINK IN MY PERSONAL OPINION REVIEW IS A LITTLE BIT BETTER IF THE COHORTS OF APPLICATIONS THAT COME TOGETHER ARE A LITTLE BIT MORE BULK TOGETHER INSTEAD OF LIKE ONE ON, ONE OFF. THAT IS PROBABLY NOT GOOD ENOUGH REASON TO SAY WE SHOULDN'T HAVE MULTIPLE SUBMISSION DEADLINES. FOR RIGHT NOW THIS IS ACTUALLY THE PATTER THAN WORKS, THAT DOESN'T MEAN WE COULDN'T CONSIDER SOMETHING ELSE IN THE FUTURE. >> I HAVE A PUERTO RICO QUESTION THE CENTER THERE, IS IT VIABLE? DO THEY HAVE ELECTRICITY IS IT UP AND RUNNING? >> THE SURPRISING PART WAS ACTUALLY THAT, YOU KNOW, YES, THEIR WATER TREATMENT SYSTEM, MAUREEN HELP ME IF I'M DOING THIS WRONG, WAS KNOCKED OUT AND THEIR POWER SUPPLY WAS PARTIALLY KNOCKED OUT. BUT THEY WERE ACTUALLY RELATIVELY SOON BACK OPERATIONAL THEY HAD ON THE ISLAND, MAIN ISLAND NO ANIMAL LOSS WHATSOEVER ON CAYO WHEN THEY COUNTED THE ANIMALS THEY LOST HANDFUL OF ANIMALS. IT WAS JUST UNBELIEVABLE. WORKERS WERE INCREDIBLE. THEY WALKED FOR HOURS TO GET TO THE SITE AND WORK AND TAKE CARE OF THINGS THAT NEEDED TO BE TAKEN CARE OF. NATIONAL PRIMATE RESEARCH CENTERS ON THEIR OWN, NOT OUR MONEY, NOT NIH MONEY, THEY PUT A TRUCK TOGETHER -- A CONTAINER TOGETHER WITH NEEDED ITEMS, THEY THE HARDEST THINGS WAS ACTUALLY HOW TO UNLOAD THE THING AND DISTRIBUTE IT PROPERLY. IN ANSWER TO YOUR QUESTION, THEY ARE OPERATING REASONABLY WELL AND WE ARE KEEPING VERY CLOSE EYE ON THEM SEE LIKE WRITE THIS APPLICATION, ARE YOU SURE, CAN YOU WRITE IT, DO YOU NEED HELP, NOT FROM US, OF COURSE. CAN YOU DO IT. SO FAR WE HAVE ACTUALLY GOTTEN UP. >> WHAT KIND OF -- WHAT KIND OF MOUSE IS THAT? >> THAT'S MY FUTURE MOUSE. THAT'S MY LEOPARD MOUSE. >> WE THINK IS IT A CHEETAH MOUSE? >> IT'S A CHEETAH MOUSE. THANK YOU VERY MUCH. IF THERE ARE NO MORE QUESTIONS. APPRECIATE IT. >> THANK YOU, THAT WAS REALLY LOVELY TO HEAR ACTUALLY ABOUT PRIMATES IN PUERTO RICO. NOW GOING TO TURN TO THE FINAL UPDATE OF THE DAY, THIS WILL BE FOLLOWED BY DISCUSSION THEN PUBLIC COMMENT. THAT LAST UPDATE IS THE UPDATE FROM THE NATIONAL INSTITUTE OF MENTAL HEALTH ON HIV/AIDS RESEARCH BEING DELIVERED BY THE HEAD OF NIMH DR. DIANNE RAUSCH. SHE IS DIRECTOR OF THE AIDS RESEARCH, DIVISION SHE LEADS SUPPORTS BROAD RANGE OF RESEARCH THAT INCLUDES BASIC AND CLINICAL NEUROSCIENCES IN HIV INFECTION, LOT OF FOCUS ON THE CNS THEN ALSO BASIC AND APPLIED BEHAVIORAL SCIENCE TO PREVENT NEW HIV INFECTIONS TO LIMIT IMPACT ON THOSE WHO ARE LIVING WITH HIV. >> THANK YOU VERY MUCH FOR LETTING ME COME AND DO THIS. BEFORE I START I DO WANT TO SAY THAT I'M SPEAKING FOR DR. JOSH GORDON OUR NEW DIRECTOR HE COULDN'T MAKE IT TODAY BUT SENDS HIS REGRETS. HE'S A PSYCHIATRIST AND NEURO SCIENTIST, SEES PATIENTS, HE HAS A LAB AND HE'S VERY SMART AND WE'RE REALLY HAPPY TO HAVE HIM BECAUSE HE PRECIOUS OUR SCIENCE AND HE IS VERY SUPPORTIVE OF OUR PROGRAM. I'M GOING TO GIVE A LITTLE OVERVIEW OF THE NATIONAL INSTITUTE OF MENTAL HEALTH PROGRAM THEN GIVE OVERVIEW OF THE AIDS PROGRAM AND THEN AS REQUESTED OF INTEREST I WILL GIVE SOME EXAMPLES OF DAR THEN OPPORTUNITIES FOR COST SHARING WITH NIMH, NON-AIDS PROGRAM. THE NIMH IS THE LEAD FEDERAL AGENCY FOR RESEARCH ON MENTAL HEALTH. WE SUPPORT MORE THAN 3,000 RESEARCH GRANTS AND CONTRACTS AT UNIVERSITIES AND INSTITUTIONS ACROSS THE COUNTRY AND OVERSEAS. WE SUPPORT INTER-MURAL RESEARCH PROGRAM WITH ABOUT 600 SCIENTISTS WORKING ON THE NIH CAMPUSES. THE VISION IS TO SEE A WORLD WHICH MENTAL HEALTH, MENTAL ILL NESSES ARE PREVENTED AND CURED. THE VISION AND MISSION TO TRANSFORM THE UNDERSTANDING AND TREATMENT OF MENTAL ILLNESS THROUGH BASIC AND CLINICAL RESEARCH PAVING THE WAY FOR PREVENTION AND CURE. TO MEET THE MISSION AND THE VISION, THERE ARE FOUR OBJECTIVES TO DEFINE THE MECHANISMS OF COMPLEX BEHAVIORS WHICH IS COMPLEX TASK. TO CHART MENTAL ILLNESS TO DETERMINE WHEN, WHERE, HOW TO INTERVENE. THAT IS A REAL HIGH PRIORITY BECAUSE EARLY INTERVENTION HAS BEEN SHOWN AMONG MANY MENTAL ILL NESSES TO HAVE -- END WITH BETTER HEALTH OUTCOMES, MENTAL HEALTH OUTCOMES. STRIVE FOR PREVENTION AND CURES, TO STRENGTHEN THE PUBLIC HEALTH IMPACT OF NIMH SUPPORTED ESEARCH. THE INSTITUTE IS DIVIDED, HAS FOUR DIVISIONS. DIVISION OF NEUROSCIENCE AND BASIC BEHAVIORAL SCIENCE, DIVISION OF TRANSLATIONAL RESEARCH AND DIVISION OF SERVICES AND INTERVENTION RESEARCH. GOES ACROSS BASIC TRANSLATIONAL INTERVENTION. THEY WORK CLOSELY WITH FEDERAL AGENCIES IN LOCAL ORGANIZATIONS AND HEALTH CARE SYSTEMS TO PROVIDE VARIETY OF WAYS IN WHICH TO GET EVIDENCE-BASED PRACTICE RESEARCH INTO THE PUBLIC DOMAIN AND TO THE PEOPLE WHO NEED IT. THE AIDS IS CONSIDERED DIVISION OF AIDS RESEARCH CONSIDERED A CROSS-CULTING DIVISION AND AS YOU'LL SEE WHEN I GO INTO IT WE DO SUPPORT RESEARCH ACROSS BASIC TRANSLATIONAL AND I AM MI MEN TAKES SCIENCE. THERE ARE OTHER CROSS CUTTING OFFICES, DISPARITIES, GLOBAL MENTAL HEALTH, GENOMICS AND TECHNOLOGY. THOSE ARE THE AREAS THAT ARE PROBABLY MOST LIKELY THAT WE CAN DO SOME SHARING OF OUR APPROACHES. FEELS IT'S IMPORTANT -- IN ORDER TO REACH THE GOALS TO HAVE SHORT , MEDIUM, LONG TERM GOALS TO GET TO APPROACH THE SCIENCE. THE GOALS ARE EARLY INTERVENTION AND SUICIDE PREVENTION THOSE ARE THE TWO HIGHEST PRIORITIES AT THIS TIME TO GET IMPLEMENTABLE EVIDENCE-BUYSED PRACTICES AND KNOWLEDGE GAPS OUT THERE. MEDIUM GOALS ARE NEUROCIRCUITS TO DEVELOP TECHNOLOGIES TO INTERROGATE NEUROCIRCUITS ULTIMATELY IMPROVE THE UNDERSTANDING AND TREATMENT OF MENTAL DISORDERS. THIS IS AN AREA THAT I'LL TALK ABOUT IN A FEW MINUTES THAT I THINK IS POTENTIAL FOR CROSS CUTTING INTEREST. LONG TERM GOALS ARE COMPUTATIONAL PSYCHIATRY TO DEVELOPMENT COMPUTATIONAL PERSPECTIVES AND APPROACHES TO IMPROVE THE UNDERSTANDING AND TREATMENT OF MENTAL HEALTH DISORDERS. I'M GOING TO TURN TO AN OVERVIEW OF THE -- THERE'S ONE OTHER POINT I WANTED TO MAKE HERE. THAT IS, ALL OF THE FUNDING FOR AIDS WORK IS DONE WITHIN THE DIVISION OF AIDS RESEARCH. ALL OF THE AIDS RESEARCH WE FUND IS 100% AIDS RELEVANT. WE DON'T HAVE CROSS SHARING PROGRAM YET. AS I SAID WE HAVE SOME IDEAS I'M GOING TO SHARE THEM BUT AT THIS POINT IN TIME THE DIVISION OF AIDS RESEARCH IS REALLY ENTITY IN AND OF ITSELF. NOW TO GO TO THE AIDS PROGRAM. OUR MISSION TO REDUCE GLOBAL INCIDENTS OF AIDS, TO REDUCE MORBIDITY AND MORTALITY AND VERY ACTIVE IN THE CURE RESEARCH EFFORT. OUR PRIORITIES BASIC AND APPLIED BEHAVIORAL AND SOCIAL SCIENCE, BASIC AND CLINICAL NEURAL SCIENCE AND MENTAL HEALTH RESEARCH TO IMPROVE TREATMENT AND PREVENTION. THE GOALS OF THE BEHAVIORAL SCIENCES TO DEVELOP TESTS AND IMPLEMENT INTERVENTIONS TO PREVENT THE SPREAD OF HIV INFECTION AND IMPROVE HEALTH OUTCOMES. THE BASIC NEUROSCIENCE GOAL TO IDENTIFY MECHANISMS UNDERLYING HIV INDUCED CNS DYSFUNCTION AND DEVELOPMENT THERAPEUTIC STRATEGIES TO PREVENT AND TREAT THEM I'LL EXPLAIN THE PRIORITIES BIT MORE DETAIL. WE DO THIS ACROSS THE LIFE SPAN, WE HAVE A STRONG INFANT CHILD AND ADOLESCENT PROGRAM WE'RE INTERESTED IN THE CNS COMPLICATIONS FROM BEING -- PERINATAL INFECTION AND THE LIVING WITH HIV FROM CHILDHOOD ON. WE ALSO HAVE VERY STRONG ADOLESCENT PROGRAM IN PREVENTION AND PROMOTING POSITIVE HEALTH OUTCOMES THROUGH -- TREATMENT, ET CETERA. ALSO RECOGNIZE THAT AGING IS REALLY IMPORTANT, PEOPLE ARE LIVING LONGER WITH HIV. AND THERE ARE PREVENTION AS WELL AS TREATMENT ISSUES AROUND AGING POPULATION. WE CAN'T FORGET THE GENERAL POPULATION ALSO KEY POPULATIONS, HEALTH DISPARITIES ISSUES AROUND MEN, WOMEN AND HARD TO REACH POPULATIONS, WE REALLY DO COVER THE SPECTRUM. THE DIVISION OF AIDS RESEARCH IS VERY MUCH WORKS ACROSS BOTH BASIC DISCOVERY SCIENCE, TRANSLATIONAL SCIENCE AND IMPLEMENTATION SCIENCE. THAT IS BOTH IN THE BEHAVIORAL AND SOCIAL SCIENCE ARENA AS WELL AS NEUROSCIENCE ARENA WE HAVE STRONG INTERESTED IN MENTAL HEALTH ACROSS ALL OF WHAT WE DO. I'LL TALK ABOUT THAT A BIT MORE. I LIKE TO SHOW THIS SLIDE, IT WAS FROM A PAPER THAT WAS DONE BY PAUL AT O.A.R. AND MIKE AT NI MH IT IS A FUNCTIONAL FRAMEWORK FOR THE BEHAVIOR ON SOCIAL SCIENCE, IT'S ACROSS EVERYTHING WE DO AND HIV/AIDS PREVENTION CARE AND CURE. THE WAY -- THEY DIRECT THIS INTO FOUR PILLARS, BASIC BEHAVIORAL AND SOCIAL SCIENCES CRITICAL TO UNDERSTANDING VULNERABLE POPULATIONS, DEFINE RISK SETTINGS WAYS TO ADDRESS THOSE RISKS. ELEMENTAL BASIC BEHAVIOR AND SOCIAL SCIENCE TO TARGETED TO IMPROVING THE BEHAVIOR AND SOCIAL FACTORS THAT IMPACT RISK AND RISK REDUCTION EFFORTS. SUPPORTIVE BEHAVIOR AND SOCIAL SCIENCE, STRENGTHENING BIOMEDICAL PRODUCT DEVELOPMENT, IMPLEMENTATION OF INTERVENTIONS IN CLINICAL TRIALS FOR BETTER EFFICACY. FINALLY INTEGRATIVE BEHAVIOR AND SOCIAL SCIENCE WHICH CONTRIBUTES TO THE EE TECH FIEF IMPLEMENTATION OF KNOWN EFFECTIVE STRATEGIES AND MULTI- LEVEL SETTINGS. THIS DEFINES BREADTH OF WHAT WE DO IN THE BEHAVIORAL AND SOCIAL SCIENCE. WE ALL KNOW THAT THE KEY TO GET -- WE HAVE LOT OF IMPORTANT INTERVENTIONS THAT ARE EFFECTIVE BUT WE ALSO HAVE NEW DISCOVERY. OPPORTUNITIES TO DISCOVER NEW THINGS ALSO HAVE LOT OF -- VERY IMPORTANT TO ALSO TRANSLATE THESE INTO INTERVENTION, IS THAT CAN BE TAKEN UP BROADLY AND EFFECTIVE IN A BROAD SCALE. SO THE FIRST STEP OF COURSE IS TESTING, HOW TO GET PEOPLE TESTED. IF THEY TEST NEGATIVE, FIND WAYS TO GET THEM LINKED TO PREVENTION EFFORTS. STAY NEGATIVE THROUGH UPTICK OF PREP, BEHAVIOR MODIFICATION AND ROUTINE HIV TESTING. IF THEY TEST POSITIVE GET THEM LINKED TO CARE, IMPROVE ADHERENCE, NOT ONLY FOR BETTER HEALTH OUTCOMES BUT ALSO FOR TREATMENT AS PREVENTION. ACROSS ALL OF THESE ARE THE PSYCHOLOGICAL PROCESSES THAT CAN HAVE IMPACT AT EACH STAGE OF THIS AND WE'RE VERY INTERESTED IN ADDRESSING THESE ACROSS TRAJECTORY. ALSO FUND STRUCTURAL STUDIES TO LOOK AT THE IMPACT OF POLICIES OR FINANCIAL ASSISTANCE, POVERTY , FOOD SECURITY, WE HAVE PARTICULAR INTEREST IN VIOLENCE HOW THAT -- HOW WE CAN IMPACT AGAINST VIOLENCE BOTH TO CHILDREN AS WELL AS INTIMATE PARTNER VIOLENCE IN BOTH MEN AND WOMEN. WE ALSO KNOW THAT SOCIAL NETWORKS ARE REALLY IMPORTANT SO WE HAVE STUDIES TARGETING THOSE. SO LOOKING NOW, TURNING TO THE NEURO. THE CLINICAL PICTURE IS CHANGING YOU HEARD THAT A LITTLE BIT FROM DR. SHARPLESS. IN THE EARLY DAYS BEFORE THERE WAS LOT OF VIRUS IN THE CNS, MULTI-NUCLEATED GIANT CELLS, THAT CAUSED NEURAL DAMAGE, ALSO VIRAL TOXICITY, INFLAMMATION, ENCEPHALITIS, THIS LED TO VERY SEAR AIDS DEMENTIA TO PARALYSIS, PREDICTED RAPID DISEASE PROGRESSION IN ACCELERATED MORTALITY. IN THE CURRENT ERA, THERE'S STILL HIV IN THE CNS WE KNOW THAT HIV GETS INTO THE CNS AS EARLY AS EIGHT DAYS AFTER INFECTION. IT RESIDES IN THE CNS IN GLIAL CELL, IN MULTI-GLIAL CELLS AND MACROPHAGES ALSO SOME EVIDENCE THAT IT RESIDES IN OTHERS. ALSO KNOW THERE'S SUBCLINICAL INFLAMMATION. VASCULAR. BUT MUCH MORE SUBTLE THAN IT USED TO BE. WE SEE MUCH MORE MILD COG COGNITIVE CHANGES. THERE IS SOME EVIDENCE OF ACCELERATED AGING BUT THE OTHER THING THAT IS REALLY HAVING AN IMPACT ON THE FUNCTION OF INDIVIDUALS LIVING LONG TERM WITH AIDS IS COMORBIDITIES. THIS CAN INCLUDE DRUG INTER- ACTIONS, FROM MULTIPLE USE OF DRUGS, POLYPHARMACY AS PEOPLE GET OLDER GET TREATED FOR OTHER DISEASES, AGING, HEART DISEASE, MENTAL HEALTH ISSUES. TRY TO LOOK AT CLINICAL PICTURE WE HAVE TO INTEGRATE SOME OF THESE OTHER BODY SYSTEMS TO REALLY UNDERSTAND WHAT'S GOING ON. ALSO WE KNOW THAT ADHERENCE AND SOCIAL SUPPORT CAN HAVE GOOD ADHERENCE AND GOOD SOCIAL SUPPORT CAN HAVE POSITIVE IMPACT , BAD ADHERENCE, BAD SOCIAL SUPPORT CAN HAVE NEGATIVE IMPACT WE HAVE TO PAY ATTENTION TO THOSE FACTORS, TOO. WE HAVE STRONG PROGRAM PLOOKING AT LATENCY AND DETECTION OF VIRUS AND WHERE IT'S AT. WE'RE VERY INTERESTED IN FINDING WHAT THE MECHANISMS OF PATHOGENESIS ARE IN AN ERA WHERE THERE'S MUCH LESS VIRUS WITHIN THE CNS AND WE'RE ALSO VERY INTERESTED IN THERAPEUTICS, WE'RE INTERESTED IN TARGETING THERAPEUTICS TO IMPROVE HEALTH OUTCOMES AND IMPROVE MOTOR COG ANY SIEVE FUNCTION. WE ALSO KNOW THAT -- BECAUSE OF THE POLYPHARMACY THAT MAY HAPPEN , THERE COULD BE SOME PHARMACODYNAMIC, NEGATIVE INTER- ACTIONS, EVEN ANTI-RETRO- VIRALS CAN HAVE SOME CNS TOXICITY. WE HAVE STRONG PROGRAM LOOKING AT THE THERAPEUTICS. COLLABORATE WITH EVERYONE. WE ARE ACTIVELY INVOLVED IN THE NIAD CLINICAL TRIALS NETWORK, CO FUND ALL OF THEM, WE SERVE AS COMMITTEES AND WE REALLY -- IT'S BEEN A GREAT COLLABORATION TO BE PART OF THE NETWORKS AND EXPAND THE SCIENCE. WE WORK WITH -- ALSO WORK WITH THE COHORT NETWORKS, WE WORK WITH THE NICHD, ATN, ACTIVE PARTNERS. WE ALSO WORK VERY CLOSELY WITH OUR FEDERAL PARTNERS, CDC, MILITARY HIV RESEARCH PROGRAM. THIS IS ALL DONE BOTH DOMESTICALLY AND INFER NATIONAL LY WE HAVE A VERY BROAD PROGRAM. OF COLLABORATION. NOW I'M GOING TO TURN TO OF DAR SPECIFIC PRIORITIES IDENTIFY WHAT MIGHT BE SOME OPPORTUNITIES FOR COST SHARING WITH NIMH NON- AIDS WHICH HAS NOT BEEN THE CASE SINCE THE BEGINNING. FIRST AND MOST OBVIOUS IS MENTAL HEALTH. I'M GOING TO FOCUS ON DEPRESSION , BECAUSE DEPRESSION IS WHAT IS THE MOST PREVALENT. IT'S MOST COMMON MENTAL HEALTH DISORDER AMONG PEOPLE LIVING WITH HIV, HAS NEGATIVE IMPACT ON THE HIV CARE CONTINUUM ALSO UN TREATED AMONG PEOPLE LIVING WITH HIV. THAT WAS CASCADE PUT TOGETHER BY BRIAN PENCE OF ALL THE PREVALENT CASES OF DEPRESSION, LESS THAN HALF ARE CLINICALLY RECOGNIZED, LESS THAN 20% ARE ON ANY TREATMENT AT ALL. TO HAVE REALLY ADEQUATE TREATMENT OR ACHIEVE REMIX IS PRETTY UNLIKELY. THIS IS AN AREA THAT IS REALLY IMPORTANT TO US. THE NIMH WITHIN PAST FEW YEARS DEVELOPED THIS GLOBAL MENTAL HEALTH AND BEYOND PROGRAM. GLOBAL MENTAL HEALTH PROGRAM AND THEIR GOAL WAS TO EXPAND STRATEGIES TO REDUCE MENTAL HEALTH DISPARITIES ACROSS THE WORLD, TO SUPPORT RESEARCH CAPACITY BUILDING, DEVELOP NEW STRATEGIES FOR THE DELIVERY OF HIV CARE AND SUPPORT RESEARCH MENTORING TO BUILD UP INTER- DISCIPLINARY WORKFORCE. THEY HAVE SET UP THESE HUBS ALL OVER THE WORLD THAT HAVE DEVELOPED RESEARCH PARTNERSHIPS FOR SCALING UP MENTAL HEALTH INTERVENTION IN LOW AND MIDDLE INCOME COUNTRIES. THAT'S REALLY IMPORTANT GOAL IN THE INTERNATIONAL AIDS ARENA. HAVE BEEN VERY SUPPORTIVE OF THIS, I THINK THAT THIS IS AN AREA THAT WE CAN WORK REALLY CLOSELY WITH OUR MENTAL HEALTH PARTNERS IN THE NON-AIDS ARENA TO BUILD AND SYNERGIZE ON WHAT WE'RE DOING. LOT OF THE INFRASTRUCTURE THAT THEY HAVE BUILT UP OVERLAPS WITH A LOT OF PEPFAR INFRASTRUCTURE THAT'S WHAT WE WORK WITH PREPPY CLOSELY. WE'VE ALREADY GOT LOTS OF IDEAS AND PLANS TO PURSUE THIS. ANOTHER AREA THAT CROSSES OVER INTO THE INSTITUTE IS STIGMA. WE ALL KNOW STIGMA IS A BARRIER TO PREVENTION AND TREATMENT. IT'S A BARRIER TO TESTING, CARE AND ENGAGEMENT AND RETENTION, MEDICATION USE. BUT IT TAKES MULTIPLE FORMS IN ORDER TO GET AT STIGMA WE REALLY HAVE TO UNDERSTAND THE MECHANISMS AND PATHWAYS TO DEVELOP EFFECTIVE INTERVENTIONS TO REDUCE IT. THIS IS A MODEL OF ALL THE DIFFERENT COMPONENTS OF STIGMA THAT CAN BE INTERVENED UPON. THERE ARE PREDICTORS OF STIGMA AND IT CAN BE ENACTED AT AN INDIVIDUAL LEVEL, AT A COMMUNITY LEVEL. THERE ARE MECHANISMS, INTERPERSONAL, PSYCHOLOGICAL, MENTAL HEALTH AND STRESS PROCESSES THEN THEY HAVE STIGMA CAN HAVE AFFECT ON CARE AND OUTCOME. TO GIVE AN EXAMPLE OF THE KIND OF MECHANISMS OF STIGMA THAT WE ARE INTERESTED IN, THIS IS MEDIATION ANALYSIS OF THE DIFFERENT COMPONENTS THAT HAVE IMPACT FROM STIGMA ON TO ADHERENCE. THERE'S A DIRECT TRAJECTORY IF THERE IS HIGH INTERNALIZED STIGMA ON ADHERENCE BUT ALSO CAN BE MEDIATED BY OTHER PIECES. IF YOU HAVE INTERNALIZED STIGMA IT CAN RESULT IN SOCIAL ISOLATION, DECREASED SOCIAL SUPPORT THAT CAN ALSO ADD TO THE THE AFFECT OF THE STIGMA. BUT GOOD SOCIAL SUPPORT CAN HAVE IMPROVED ADHERENCE. IF WE LOOK AT THESE DIFFERENT COMPONENTS AND HOW THEY INTER- ACT WITH EACH OTHER WE CAN IDENTIFY AREAS TO TARGET BOTH INDIVIDUALLY AS WELL AS IN COMBINATION THAT MIGHT BE ABLE TO HAVE MORE EFFECTIVE IMPACT ON THE STIGMA. I WANT TO TALK A LITTLE BIT ABOUT DEPRESSION. CURRENTLY DEPRESSION IS DEFINED AS A BEHAVIORAL SYMPTOMOLOGY. WE DON'T HAVE ANY BIOMEDICAL MARKERS OF DEPRESSION THAT WE CAN ACTUALLY USE. AND MOST OF THE DRUGS THAT ARE USED TO TREAT DEPRESSION HAVE BEEN SERENDIPITOUSLY DEVELOPED OR IDENTIFIED AND THEY TARGET SYMPTOMS BUT NOT THE MECHANISM. SO THERE'S A LOT OF INTEREST IN FINDING BIOLOGICAL MECHANISMS THAT MIGHT -- MARKERS THAT MIGHT UNDER -- DEFINE DEPRESSION IN MORE STRUCTURED WAY THAT CAN THEN BE INTERVENED UPON. LOT OF NEW INTEREST NOW IN THE NEUROIMMUNE ACCESS BECAUSE DISTURBING THAT CAN DISTURB, DISRUPT NEUROCIRCUITRY, PERHAPS RESPONSE OF STRESS ON NEURAL FUNCTION. ESPECIALLY WITH IMPROVED TECHNOLOGY THAT'S OUT THERE WE CAN BEGIN TO LOOK AT SOME OF THE NEUROIMMUNE MECHANISMS OF DEPRESSION AND INFORM OUR INTERVENTIONS, JUST SOME EXAMPLES OF THIS. THIS WAS STUDY THAT WAS DONE IN THE ACUTE INFECTION GROUP IN THAILAND, THEY SHOWED THAT ACUTE INFECTION, DEPRESSION AND ANXIETY ARE COMMON, ASSOCIATED WITH PLASMA IMMUNE ACTIVATION NOT JUST, OH, YOU'RE HIV POSITIVE THERE FOR YOU'RE DEPRESSED. THERE ARE IMMUNOLOGICAL FACTORS AND MARKERS THAT GET ELEVATED THAT CAN BE TARGETED TO BETTER UNDERSTAND IT. WE ALSO, THERE'S A LOT OF WORK NOW ON MOB SIGHT TRAFFICKING TO THE GRAIN WHICH CAN THEN INFLUENCE SOME MOOD AND BEHAVIOR OUTCOMES. THESE ARE SOME AREAS THAT THERE'S LOT OF INTEREST IN PURSUING, I THINK HIV CAN BE A MODEL IN SOME WAYS TO DO THIS. I'M GOING TO SHOW A LITTLE BIT OF DATA THAT WAS FUNDED BUT BEFORE I TALK ABOUT THE STUDY, I WANT TO PUT IT IN CONNEXT. YOU ALL KNOW ABOUT COLLABORATORIES THAT NIAD FUNDS AND WE COFUND LOOKING AT WAYS TO ADDRESS LATENCY AND HIV RESERVOIRS AND THERE WAS A STUDY DONE BY STEVE AND HIS GROUP AT THE COLLABORATORY WHERE THEY WERE USING A LATENCY REVERSING AGENT TO -- FOR PATIENTS THEN MEASURING THE UNSPLICED RNA AS MEASURE OF LATENCY. WHEN THEY WERE DOING THIS STUDY THEY DID COUPLE OF PRELIMINARY MEASURES OF THE -- THIS RNA THEN ON DAY OF THE TRIAL THEY MEASURED IT IN THE SAME PATIENTS THEY FOUND A VERY DIFFERENT BASELINE OF THIS VIRAL RNA COMPARED TO THEIR PRETREATMENT MEASUREMENTS. THEY DIDN'T KNOW WHAT CAUSED THIS. WE SAW THIS DATA WE ASKED THEM TO LOOK INTO THE POSSIBILITY THAT IT COULD BE CIRCADIAN RHYTHMS BECAUSE IT WAS IN THE MORNING, COULD BE A STRESS AFFECT OR WHATEVER. THEY DECIDED TO DO THAT. WHAT THEY FOUND -- WHAT THEY DID HERE WAS TAKE 25 HIV POSITIVE, WELL CONTROLLED INDIVIDUALS WHO HAVE BEEN VIRALLY SUPPRESSED FOR MORE THAN THREE YEARS. THEY DID COUPLE OF BASELINES OF THEIR CELL ASSOCIATED UNSPLICED RNA THEN DID THIS SOCIAL STRUCTURE -- SOCIAL STRESS TEST WHICH IS A VALIDATED TEST THAT SHOWS AUTONOMIC NERVOUS SYSTEM GETS ACTIVATED AS RESPONSE TO THIS STRESS OR. AFTER THEY DID THE BASELINE AND AFTER THEY DID THE TEST THEY FOUND THAT CELL ASSOCIATED UN SPLICED RNA WENT UP IN STATISTICALLY SIGNIFICANT WAY AFTER THE STRESS TEST BUT DNA STAYED THE SAME. THEY CONCLUDE THAT STRESS COULD BE MEDIATING FACTOR FOR THIS OF THESE STUDIES THAT THEY'RE DOING STUDYING RESERVOIRS BUT THEY ALSO THINK IT MIGHT INFORM SOME NEW WAYS OF TARGETING THE RESERVOIR. WE ALSO THINK THAT THIS COULD BE A MODEL THAT WE CAN BEGIN TO SAY WE HAVE A DIRECT STIMULUS, DIRECT AFFECT THAT WE CAN BEGIN TO STUDY SOME OF THE EFFECTS OF STRESS ON LONG TERM HEALTH OUTCOMES WHICH MAY NOT ALWAYS -- PEOPLE WHO ARE STRESSED BUT MAY NOT ALWAYS BE DUE TO ADHERENCE. IT'S PROVOCATIVE. WE'RE INTERESTED IN IT. THEY'RE FOLLOWING UP. WE WERE PRETTY EXCITED ABOUT IT. OTHER AREAS, HUMAN CONNECTOME PROJECT IS MAKING GREAT PROGRESS IN UNDERSTANDING THE CONNECTIVITY IN THE BRAIN AND AS YOU REMEMBER OUR NEW DIRECTOR IS VERY INTERESTED IN INTERROGATING NEUROCIRCUITS TO IMPROVE THE UNDERSTANDING AND TREATMENT OF MENTAL HEALTH DISORDERS JUST PUT OUT RFA WITH SOME OF OUR SISTER WE HOPE THAT WE CAN FROM THIS IN FORM NORTHWEST NEUROCOMMUNITY ABOUT SOME OF THESE ALTERED CIRCUITS IN RESPONSE TO IMMUNE MECHANISMS AS OPPOSED TO SOME OTHER FACTORS. FINALLY MY FUTURISTIC SLIDE GIVEN ALL OF THE ADVANCES IN IMAGING TECHNOLOGY, WE CAN NOW DO REALTIME ANALYSIS OF PEOPLE'S THOUGHTS AND ACTIONS AND GET A LOT OF INFORMATION ABOUT HOW THE BRAIN FUNCTIONS AND WE'RE DOING A LOT OF THIS NOW IN HIV POSITIVE PEOPLE TO LOOK FOR SIGNALS OF NEURAL DAMAGE TRY TO UNDERSTAND SOME OF THE MORE SUBTLE NEURAL DAMAGE THAT MAYBE TAKING PLACE. AGAIN WE'RE WORKING WITH A LOT OF OUR SISTER INSTITUTES TO DO THIS. I'LL STOP THERE I'M HAPPY TO TAKE ANY QUESTIONS. >> THANK YOU SO MUCH. I HAD QUESTION TO START US OFF EARLY CAREER IN VEST GATORS WILL ASK ME ABOUT. PAY LINES THAT ARE POSTED BY DIFFERENT INSTITUTES. I WAS CURIOUS THAT THE NIMH DIDN'T EVER SPECIFICALLY POST PARTICULAR PAY LINES LIKE NIAD DOES. IF THAT WAS A POLICY AT THE INSTITUTE WHERE THAT CAME FROM OR HOW YOU ADDRESSED THAT. I THINK IT'S PROBABLY GOOD THING FOR THEM. TO NOT BE HELD TO THESE CERTAIN NUMBERS BUT I'M JUST CURIOUS OF THE HISTORY OF THAT. >> WE DON'T PUBLISH OUR PAY LINES BECAUSE OUR FUNDING IS SEPARATE FROM NIMH, DOES FUND SOME INFORMATION ON WHAT THEY'RE FUNDING, WE DON'T BECAUSE OUR BUDGET, I PURPOSELY DIDN'T INCLUDE A BUDGET SLIDE BECAUSE OUR BUDGET IS COMPLICATED. OUR BUDGET -- WE CAN'T DO IT UNTIL WE GET A BUDGET AND WE HAVEN'T HAD ONE. ONCE WE GET A BUDGET THEN IT DEPENDS ON A LOT OF THINGS WE ALSO SHARE PART OF OUR BUDGET WITH NIAD SO SOME OF OUR FUNDING DECISIONS GET MADE IN COLLABORATION WITH NIAD. WE ALSO HAVE CERTAIN SMALL POTS OF MONEY THAT MAY BE AT O.A.R. THAT WE AREN'T SURE ARE GOING TO BE -- WE JUST -- SO MUCH UN CERTAINTY THAT WE CAN'T REALLY DO IT. WE TRY TO FUND UP TO THE 9TH OR 10TH PERCENTILE UNTIL WE GET MONEY. ALSO WE HAVE TO SEE HOW MANY APPLICATIONS COME IN. NUMBER OF APPLICATIONS THAT HAVE BEEN COMING TOWN NIMH HAS INCREASED PRETTY DRAMATICALLY OVER THE PAST COUPLE OF YEARS. SO THE OTHER THING THAT WE'RE TRYING TO DO IS BECAUSE FUNDING IS FLAT AND PRIORITIES ARE BROADENING ACROSS COMORBIDITIES, ET CETERA. WE'RE TRYING TO STAY FOCUSED ON WHAT KIND OF RESEARCH NIMH CAN FUND. WE'RE ACTIVE COLLABORATION WITH NATIONAL INSTITUTES OF HEALTH ND S, INSTITUTE OF AGING AND DRUG ABUSE TO SORT OF PARSE OUT WHAT EACH OF US WILL FUND. UNTIL WE GET SOME CERTAINTY ABOUT WHERE WE'RE GOING, WE'RE JUST TAKING IT ONE STEP AT A TIME. >> FANTASTIC. JUST ONE VERY QUICK QUESTION. WHICH IS, WHAT IS PORTION OF THE BUDGET THAT YOU GIVE OUT IS FOCUSED ON BASIC SCIENCE VERSUS BEHAVIORAL. YOU HAD THAT SPLIT. >> TRADITIONALLY WE HAD 60% BEHAVIORAL AND 40% BASIC NEURO SCIENCE. BECAUSE OF THE WAY THE EPIDEMIC IS EVOLVING AND THE CLINICAL PICTURES THOSE LINES HAVE BECOME REALLY FUZZY. WE ACTUALLY DO A PORTFOLIO ANALYSIS EVERY CYCLE AROUND TO MAKE SURE THAT WE ARE FAIRLY COVERING ALL THE DIFFERENT AREAS I TRY TO KEEP IT 60-40 BUT IT DEPENDS ON HOW YOU CODE IT. >> WAS THAT DECIDED A PRIORITY BECAUSE IT'S BEST OR TRADITION. >> IT'S OUR TRADITION. IT'S SUBJECT TO CHANGE. >> I GUESS I'M REALLY INTERESTING YOU MADE VERY POWER FUL ARGUMENT WHY MENTAL HEALTH IS IMPORTANT FOR PEOPLE WITH HIV. IN IT'S OWN RIGHT WHAT ARE INTERVENTIONS TO HELP PEOPLE. THERE'S ANOTHER SPACE I GUESS WHICH IS THAT OVER THE PAST TEN YEARS THERE'S BEEN A WELL RECOGNIZED I GUESS UNDERSTANDING THAT THE MOST EFFECTIVE INTERVENTIONS WE HAVE ARE BIOMEDICAL. THAT THE BEHAVIORAL ASPECTS TOWARDS PREVENTIONS WILL BE THROUGH CHANGING PATIENT'S BEHAVIOR IN TERMS OF PILL TAKING OR IN TERMS OF CLINICIAN BEHAVIOR OR IN TERMS OF OTHER BEHAVIORS BUT IT'S NOT NECESSARILY FOCUSED ON HAVING PEOPLE USE CONDOMS EVERY TIME THEY HAVE INTERCOURSE. HOW DID THAT CHANGE IN YOUR PORTFOLIO LIKE HOW DID YOU EMBRACE THE BIOMEDICAL PORTFOLIO >> HOW DID WE OR HOW DO WE? >> I ASSUMED IT'S PAST TENSE MAYBE IT'S PRESENT TENSE IT'S AN ACTIVE PROCESS. HOW IS THAT HAPPENING? >> BUY INTO THE INTEGRATED APPROACH VERY STRONGLY. WE KNOW THAT BEHAVIOR CHANGE ALONE IS NOT GOING TO STOP THE EPIDEMIC. IF EVERYBODY STOPPED HAVING SEX AND STARTED USING CONDOMS WHEN THEY DID, WE PROBABLY MAKE A DENT BUT THAT'S NOT GOING TO HAPPEN. WE THINK THAT INTEGRATED BIOMEDICAL BEHAVIORAL APPROACH IS CRITICAL. SO ALMOST EVERYTHING THAT WE DO, WELL, I SHOULDN'T SAY THAT. WE STILL HAVE VERY STRONG BASIC BEHAVIORAL AND SOCIAL SCIENCE AGENDA BECAUSE WE REALLY NEED TO UNDERSTAND THE FACTORS THIS PUT PEOPLE AT RISK. THE REASONS WHY PEOPLE WON'T -- WE CAN DO INTERVENTIONS TO IMPROVE TESTING. MOST OF THE BEHAVIORAL AND SOCIAL SCIENCE WORK THAT WE DO IS TARGETED TO BETTER INTEGRATE AND GET BETTER IMPROVE UPTAKE, USAGE AND ADHERENCE TO THE BIOMEDICAL APPROACHES. BECAUSE WE REALLY BELIEVE THAT THAT IS -- EVEN FROM ALL THE WAY FROM TRANSLATIONAL INTO IMPLEMENTATION SCIENCE. IT'S AN INTEGRATED APPROACH. MOST OF -- ALL OF OUR NETWORK WORK IS INTEGRATED. WE HAVE VERY SIGNIFICANT AMOUNT VESTED IN ALL THE NETWORK. >> LINDA? >> SO, DIANNE, MORAL CIRCUITS, TO INTERROGATE CIRCUITS THAT'S A GREAT LINE, GIVE ME AN EXAMPLE OF THE TECHNOLOGY THAT WOULD INTERROGATE, SOUNDS LIKE ME. NEUROCIRCUITS. >> CELLS COMMUNICATE VIA RECEPTORS AND MOLECULES THAT MOVE FROM THE CELL TO THE RECEPTOR AND THEN TRANSFER DOWN SO THAT -- THAT'S HOW NEURO FUNCTION HAPPENS. THERE HAS TO BE THIS INTER- ACTION. IF IT'S INTERVENED, IMPACTED NEGATIVELY BY ALTERED CYTOKINES, INFLAMMATORY MARKERS, JUST A BREAK DOWN OF A PARTICULAR NEURO TRANSMITTER CAN HAVE TOXIC AFFECT. IF THE NEUROCIRCUITRY IS IMPAIRED AND USUALLY THOSE TOXIC MOLECULES THAT ARE PRODUCT OF SOME SORT OF BREAK DOWN CAN BE TOXIC TO NEURONS. USUALLY THERE'S A MECHANISM IN PLACE SCOOP UP THOSE TOXIC FACTORS, BYPRODUCTS GET RID OF THEM. IF THE NEUROCIRCUITRY IS NOT WORKING THEN THOSE TOXIC PIECES CAN STAY THERE, TOXIC PRODUCTS CAN CAUSE NEURONAL DAMAGE. THAT IS SIMPLISTIC WAY OF SAYING IT. THE THING ABOUT NEUROCIRCUITRY IS THAT IT'S NOT JUST ONE CELL NTER-ACTING WITH ONE OTHER CELL THERE'S CIRCUITRY THAT'S VERY COMPLEX, SO IF THIS CIRCUITRY GOING FROM A TO B NECESSARY FOR CIRCUITRY GO GO FROM B TO D THEN IF YOU BREAK D THEN C TO D NOT GOING TO WORK AND C TO D MAY HAVE COMPLETELY -- BE NECESSARY FOR -- IF YOU CAN THINK OF IT AS SORT OF ARBOR OF PIECES THAT GO OUT AND INTER-ACT THROUGH DIFFERENT MOLECULES, SOLUBLE RECEPTORS, CELL SURFACES ALL THESE HAVE TO INTER-ACT. THAT'S BEEN ONE OF THE REASONS IT'S BEEN SO HARD TO REALLY UNDERSTAND MENTAL HEALTH BECAUSE THEY'RE ALL SO INTER-CONNECTED TO BEGIN TO SEE PATTERNS AND THAT'S ACTUALLY WITH THE NEURO CONNECTION. BEGINNING TO SEE PATTERNS THAT IF YOU INTER-ACT IN THIS PARTICULAR PART OF THE BRAIN AND YOU GET AN AFFECT IN ANOTHER PART SOMEHOW THAT CONNECTION HAS BEEN BROKEN. CAN BEGIN TO UNDERSTAND THESE. >> WHAT SORTS OF TECHNOLOGIES WOULD HELP ELUCIDATE ALL OF THAT >> LOT IN VITRO WHERE YOU SET UP YOU CAN DO IT THROUGH ANIMAL MODELS WHERE YOU CAN, FOR INSTANCE, IN MONKEYS THE BASIC NEUROSCIENCE THAT'S DONE IN MONKEYS IS LESION IN A CERTAIN AREA, THEN THEY HEAL THEY CHECK TO SEE WHERE THAT LESION HAS AN AFFECT. YOU CAN GET SMALLER AND SMALLER LESIONS YOU CAN THEN LOOK DOWNSTREAM AFFECTS. DOES THAT HELP? >> THANKS. >> ANY OTHER QUESTION? THANK YOU. >> WE'RE JUST MARVELING AT THE BREADTH OF YOUR PORTFOLIO HOW WELL YOU DESCRIBED IT. PROBABLY DESERVE TO HEAR THAT PUBLICLY. >> THANK YOU. >> SO THIS IS THE TIME TO REMIND YOU ONE MORE TIME TO PLEASE FILL OUT THE CONFLICT OF INTEREST FORM BRING IT OVER HERE OR OUTSIDE. THEN THIS IS NOW THE TIME FOR PUBLIC COMMENTS. WE DIDN'T ACTUALLY GET ANY SPECIFIC REQUESTS, BUT YET IF ANYONE WANTS TO MAKE PUBLIC COMMENT WHO IS HERE, FOR EXAMPLE , YOU WOULD PLEASE GET UP SAY YOUR NAME AND AFFILIATION AND THEN WHATEVER YOU'D LIKE TO SAY. >> THIS IS LIA. I HAVE A QUESTION THAT RESOLVES AROUND COST SHARING AND THE WAY IT AFFECTS AN INSTITUTE'S BUDGET ALLOCATION FROM O.A.R. FOR INSTANCE, WE ALL KNOW BUDGET IS STAGNANT. EACH INSTITUTE GETS A PIECE OF THE PIE, LET'S SAY. WOULD BE ABLE TO LEVERAGE THE SIZE OF THAT PORTFOLIO TO ASK FOR MORE MONEY FROM O.A.R. OR IS IT MORE OF LIKE, EVER ONE GETS SAME BUDGET, SAME BUDGET PROCESS THEN IT'S UP TO THE IC TO THEIR PIECE OF THE PIE. SHARE- >> IT IS A BIDIRECTIONAL PROCESS WE'D CERTAINLY CONSIDER THINGS, ALTHOUGH I AM NOT SURE HOW -- IT DEPENDS HOW MUCH YOUR INSTITUTE 'S BUDGET WILL INCREASE OR NOT. WE NEED TO SORT OF HAVE THIS NEGOTIATION AGAIN UP FRONT AND CONSIDER THEM IN TOTAL. >> I WAS JUST GOING TO SAY THIS ABOUT AROUND THE ISSUE OF WHY -- WHAT DRIVES THE COLLABORATION BETWEEN THE DIFFERENT INSTITUTES I JUST WANTED TO SAY THAT IN EARLY DAYS THE INSTITUTES WERE REALLY SILOED THEY HAD THEIR AGENDAS THEY HAD THEIR MISSIONS PUT OUT THEIR RFAs THEY -- THERE WAS COLLABORATION BUT I THINK -- I WAS ON THE COST SHARING COMMITTEE, TOO, LISTENED TO THE DISCUSSION I'VE ALSO BEEN AROUND FOREVER. I DO THINK THAT GIVEN THE BUDGET AND THE STATE OF THE SCIENCE AND THE BROADLY EXPANDING AGENDA, THAT THERE'S A LOT OF -- THOSE SILOS ARE BREAKING DOWN. I THINK THE ICs ARE WORKING TOGA LOT BETTER IT'S REALLY FUN TO SEE. LIKE I SAID WE'RE TRYING TO PARSE OUT -- EVERYBODY'S TRYING TO PARSE OUT WHAT THEIR PRIORITIES ARE AND DO RFAs EVEN WITH OUR RFAs OTHER INSTITUTES WILL JOIN IN. THERE IS A LOT MORE COLLABORATION GOING ON. >> THANK YOU, I THINK THAT'S THE END OF PUBLIC COMMENT. WE'RE NOW GOING TO HEAR FROM DR. GOODENOW WITH CLOSING COMMENTS FOR THIS MEETING. >> WELL FIRST OF ALL, THANK YOU VERY MUCH, ALL OF YOU. IT HAS BEEN I THINK ONE OF THE BEST -- I THINK I'VE ONLY DONE THREE OF THESE BUT THIS IS DEFINITELY THE BEST FROM MY PERSPECTIVE. THIS IS A GREAT TEAM. I'M REALLY VERY, VERY EXCITED ABOUT WORKING WITH YOU GOING FORWARD. I WANT TO TAKE THE OPPORTUNITY ALSO TO THANK THE O.A.R. STAFF IN PARTICULAR, DR. ELIZABETH CHURCH FOR ORGANIZING THAT MEET ING. I'M ALWAYS IMPRESSED. [ APPLAUSE ] SOME OF THE O.A.R. STAFF IS BACK THERE. THEY REALLY DO FANTASTIC JOB THEY JUST HAVE -- [ INAUDIBLE ] I REALLY WANT TO THANK MONICA AGAIN BECAUSE IT'S BEEN WONDERFUL HAVING YOU AS THE CHAIR. SHE DOES THESE WONDERFUL WRAP-UP S. [ APPLAUSE ] JUST VERY BRIEFLY BECAUSE I KNOW THE DAY IS LONG AND IT'S TIME TO GET OUT OF HERE. I THINK JUST FROM MY PERSPECTIVE WHAT I HEARD TODAY STARTING FROM THE VERY BEGINNING AT THE -- WITH THE REPORTS ON GUIDELINES WAS, A, HOW FAR WE'VE COME IN A RELATIVELY SHORT PERIOD OF TIME. JUST HEARING ABOUT HOW THE INITIAL PEDIATRIC START WITH IAZ T -- AZT THAT'S JUST AMAZING HOW FAR WE'VE COME IN THIS PERIOD OF TIME AND HOW I THINK WELL THE INVESTMENT BY THE AMERICAN TAXPAYERS HAS PAID OFF IN TERMS OF THE OUTCOMES OF WHERE WE ARE NOW. CERTAINLY WHAT WE'VE HEARD IS THAT THE WHOLE LANDSCAPE PARTICULARLY RESEARCH ENTERPRISE IS VERY DIFFERENT. I'M HOPING THAT YOU HEARD TODAY A GOOD WINDOW OR GOOD STORY ABOUT HOW COLLABORATIVE THE NIH IS. WHEN I FIRST CAME HERE I HAD A LOT OF INPUT FROM PEOPLE WHO SAID, NOBODY CORROBORATES, THEY'RE ALL GOING -- IT'S GOING TO BE REALLY TOUGH JOB THINGS LIKE THAT. I HAVE TO SAY THAT SINCE I'VE BEEN HERE, WHAT YOU HEARD TODAY ABSOLUTELY THE STORY ABOUT WHAT I'VE BEEN HEARING AND COLLABORATION LEVEL IS FANTASTIC I THINK REALLY WHAT'S DRIVING THAT IS THE SCIENCE. THE SCIENCE HAS GOTTEN TO THE POINT WHERE HE REALLY NEEDS THIS TYPE OF INTER-ACTIVE, TRANS DISCIPLINARY, MULTI-FACETED APPROACH IF WE'RE REALLY GOING TO NOW SOLVE THE WHOLE NEXT GENERATION OF CHALLENGES THAT WE HAVE IF WE'RE GOING TO GET WITH HIV WHERE WE WANT TO BE. THAT IS END THE PANDEMIC IMPROVE THE HEALTH OF PEOPLE LIVING WITH HIV. THAT IS REALLY AN EXCITING TIME. WE HAVE AN OPPORTUNITY TO FOCUS AND TO REALLY CAPITALIZE ON THIS NETWORK OF EXPERTISE AMONG PEOPLE WHO ARE REALLY SMART, REALLY WILLING TO WORK TOGETHER. SO THANK YOU AGAIN FOR YOUR TIME TODAY AND YOUR INPUT. LOOK FORWARD TO OUR NEXT MEETING WHICH WILL BE TELETELECONFERENCE IN JULY THEN OUR GRAND MEETING IN NOVEMBER. THANK YOU VERY MUCH. SAFE TRAVELS. [ APPLAUSE ] >> EVERYONE IS GETTING UP, WHY DON'T I JUST SAY, NO WRAP UP, JUST ADJOURN. THAT'S FINE. THANK YOU VERY MUCH.