>> GOOD AFTERNOON.
I'M EYE HOLTZ HOLTZ AND I'M THE
DESIGNATED FEDERAL FINANCIAL,
EXECUTIVE SECRETARY -- TIMOTHY
HOLTZ.
THE OFFICE OF THE OARAC.
WELCOME AND THANK YOU FOR YOUR
PARTICIPATION TODAY.
AS A BRIEF REMINDER, OUR COUNCIL
IS GOVERNED BY THE PROVISIONS OF
THE FEDERAL ADVISORY COMMITTEE
AS AMENDED WHICH SETS FORTH
STANDARDS FOR THE FORMATION AND
USE OF ADVISORY COMMITTEES.
MY ROLE AS DESIGNATED FEDERAL
OFFICER IS TO PREPARE MEETING
AGENDAS, ORGANIZE MEETINGS, AND
APPROVE ALL COUNCIL AND
SUBCOMMITTEE MEET AGO, ADJOURN
ANY MEETING WHEN IT'S DETERMINED
TO BE IN THE PUBLIC INTEREST AND
CHAIR MEETINGS WHEN DIRECTED BY
THE NIH DIRECTOR OR OAR DIREC
DIRECTOR.
AS IN PREVIOUS MEETINGS, LET'S
GO OVER GENERAL GUIDELINES FOR
TODAY.
PLEASE ALWAYS STAY MUTED UNLESS
YOU'RE SPEAKING.
PLEASE KEEP YOUR CAMERA ON FOR
MOST OF THE MEETING.
FEEL FREE TO HIDE YOUR CAMERA IF
YOU NEED TO LEAVE MOMENTARILY
AND RETURN.
WHEN YOU LIKE TO PARTICIPATE IN
DISCUSSIONS, WE ASK THAT YOU
PLEASE USE THE ZOOM RAISE HAND
FEATURE.
DR. TURN BULL, THE CHAIRPERSON,
AND I WILL NOTE THOSE WHO WANT
TO CALL ON YOU TO TRY TO AVOID
SPEAKING OVER ONE ANOTHER.
YOU'LL NEED TO LOWER THE ZOOM
HAND FEATURE ONCE YOU MADE YOUR
REMARKS.
FOR THIS MEETING, THE ZOOM CHAT
FEATURE HAS BEEN DISABLED EXCEPT
FOR MESSAGES TO THE MEETING
POSTS.
IF YOU HAVE CONCERNS, PLEASE
CALL OR TEXT ME OR
Ms. STEVENS.
OUR PHONE NUMBERS ARE IN YOUR
E-MAIL.
FOR EVERYONE ON VIDEOCAST, IF
YOU WOULD LIKE TO SEE THE CLOSED
CAPTIONS FOR THE MEETING, CLICK
THE CCI CONON THE BOTTOM -- ICON
ON THE BOTTOM RIGHT-HAND CORNER
OF THE VIDEO.
OUR POLICIES REGARDING CONFLICTS
OF INTEREST.
COUNCIL MEMBERS MAY NOT
PARTICIPATE IN THE REVIEW OR
DISCUSSION OF A SPECIFIC PROGRAM
OR PROJECT FOR WHICH THEY HAD A
REAL OR APPEARED CONFLICT OF
INTEREST.
IF A PROGRAM OR PROJECT IS
DISCUSSED THAT PRESENTS A
CONFLICT FOR YOU, EXCUSE
YOURSELF FROM THEI MEET -- SLID,
PLEASE.
THESE VISIONARIES WERE LEADERS
IN THE HIV SPACE AND MANY HAD
THE HONOR OF WORKING WITH THEM.
A PIONEER IN HIV ACTIVISM BY
EXPOSING THE HIV/AIDS EPIDEMIC
IN CHINA IN THE 1990S AND
THROUGH HER EFFORTS IN HIV
PREVENTION AND ANTI-STIGMA
EDUCATION, WHICH RESULTED IN
RECOGNITION OF HIV AND AIDS IN
CHINA AND POLICIES TO PREVENT
AND CONTROL HIV.
SHE EARNED NATIONAL AND
INTERNATIONAL ACCLAIM AND KEPT
UNDER CLOSED STATE SURVEILLANCE
AND EVENTUALLY FLED TO THE
UNITED STATES.
DR. VICTORIA ANN JOHNSON,
DEPARTMENT OF MADISON AT THE
UNIVERSITY OF ALABAMA AT
BIRMINGHAM, WAS A PIONEER IN HIV
DRUG RESISTANCE RESEARCH AND IN
THE USE OF COMBINATION
ANTI-RETROVIRAL DRUG REGIMENS
STANDARD APPROACHES IN HIV
TREATMENT.
DR. ADAORA ADIMORA WAS AN HIV
RESEARCHER AND PROFESSOR OF
MEDICINE IN EPIDEMIOLOGY AT THE
UNIVERSITY OF NORTH CAROLINA
SCHOOL OF MEDICINE AND GILLINGS
SCHOOL OF GLOBAL PUBLIC HEALTH.
SHE DEDICATED HER CAREER TO
STUDYING EPIDEMIOLOGY OF
HETEROSEXUAL HIV TRANSMISSION
AMONG AFRICAN-AMERICANS, THE
SOCIAL DETERMINANTS OF HEALTH
THAT DRIVE HIV, RACIAL AND
ETHNIC DISPARITIES AND WOMEN IN
HIV.
AND JUST TWO DAYS AGO, SADLY, WE
LOST HYDEIA, AN AIDS ACTIVIST
BORN WITH HIV AND BECAME A
LEADING VOICE IN THE FIGHT
AGAINST THE EPIDEMIC.
ADOPTED AT SIX WEEKS OLD, SHE
WAS ULTIMATELY DIAGNOSED WITH
HIV WHEN SHE WAS THREE, HAVING
CONTRACTED THE DISEASE IN UTERO.
SHE GREATLY EXCEEDED
EXPECTATIONS TO BECOME A
ACTIVIST WHO RAISED AWARENESS
ABOUT THE VIRUS, ESPECIALLY
AMONG YOUNG PEOPLE AND REFUSED
TO LET IT NEGATIVELY DEFINE HER
LIFE.
WHEN I READ THROUGH SOME OF THE
QUOTES YESTERDAY, THE THINGS SHE
SAID, I WAS STRUCK BY ONE IN
PARTICULAR FROM HER BOOK, IN
WHICH SHE SAID, I AM A WARRIOR.
I RAISE EACH DAY WITH PURPOSE
WHILE STILL BEING A WORK IN
PROGRESS.
WE WILL TURN THE MEETING TO THE
CHAIR TO DR. IVY TURNBULL, WHO
WILL BRING THE MEETING TO ORDER.
>> THANK YOU DR. HOLTZ.
AND GOOD AFTERNOON EVERYONE.
THE MEETING OF OFFICE OF AIDS
RESEARCH ADVISORY COUNCIL IS NOW
IN SESSION.
COLLEAGUES, WE WILL NOW CONDUCT
THE ROLL CALL, WHEN I CALL YOUR
NAME, PLEASE STATE YOUR POSITION
AND INSTITUTION.
OARAC VOTING MEMBERS,
DR. KATHLEEN COLLINS.
>> MY NAME IS A WELL COLLEEN:
FROM THE UNIVERSITY OF MICHIGAN
AND I'M PROFESSOR OF INTERNAL
MEDICINE WITH SPECIALTY IN
INFECTIOUS DISEASE.
>> DR. OMAR GALARRAGA.
>> HI, I'M OMAR.
I'M AN ASSOCIATE PROFESSOR IN
THE BROWN UNIVERSITY SCHOOL OF
MR.IC HEALTH.
I'M ALSO THE DIRECTOR OF THE
DOCTORAL PROGRAM IN HEALTH
SERVICES RESEARCH.
>> DR. SHRUTI MEHTA.
>> PROFESSOR AND VICE-CHAIR OF
THE DEPARTMENT OF EPIDEMIOLOGY
AT JOHNS HOPKINS AND ALSO THE
CO-DIRECTOR OF --
>> DR. SHRUTI MEHTA.
>> I [ INAUDIBLE ]
>> DR. MAG MAG.
>> HI, I'M ALAN MAGILL AND I'M
A -- - MOJGAN NAGHAVI AT
NORTHEASTERN UNIVERSITY.
>> DR. ANN.
>> I'M AN ASSISTANT PROFESSOR IN
PEDIATRICS AT HARVARD MEDICAL
SCHOOL AND INFECTIOUS DISEASES
IN MASS GENERAL HOSPITAL IN
BOSTON.
>> DR. RICARDO.
>> HELLO, EVERYONE.
CLINICAL ASSISTANT PROFESSOR AT
UNIVERSITY OF ILLINOIS,
DEPARTMENT OF FAMILY MEDICINE IN
CHICAGO AND ALSO -- [ INAUDIBLE
>> DR. A SLEETS SLEETS.
>> PROFESSOR AND CHIEF OF
IMMUNOLOGY AT THE UNIVERSITY AND
THE SCIENTIFIC LEADERSHIP GROUP
FOR THE IMPACT.
>> 2022 AD-HOC MEMBERS.
DR. AUDWIN FLETCHER.
>> COURTNEY FLETCHER, PROFESSOR
OF PHARMACY AND INFECTIOUS
DISEASES AT THE UNIVERSITY OF
NEBRASKA MEDICAL CENTER IN
OMAHA.
>> DR. DIANE SANTA MARIA.
>> GOOD MORNING.
I'M HERE AT THE SCHOOL OF
NURSING AT THE UNIVERSITY OF
TEXAS HEALTH SCIENCE CENTER IN
HOUSTON.
>> DR. ANNA MARIA.
>> I'M ANNA, A PROFESSOR OF
PEDIATRICS AT BAYLOR COLLEGE OF
MEDICINE AND TEXAS CHILDREN'S
HOSPITAL WHERE I HELP TO
CODIRECT THE -- AND FOCUS ON HIV
AND SUB-SAHARAN AFRICA.
>> DR. SONIA FLORES.
>> HI, I'M SONIA, AND I'M A
PROFESSOR AND VICE-CHAIR IN THE
DEPARTMENT OF MEDICINE AT THE
MEDICAL CAMPUS AT THE UNIVERSITY
OF COLORADO.
>> AND DR. SARAH SAWYER.
>> GOOD MORNING, EVERYBODY.
I'M SAILORRA SAWYER, PROFESSOR
IN BOLDER, COLORADO AND I'M A
VIROLOGIST AND IMMUNOLOGIST
FOCUSING ON HIV RESEARCH.
>> OARAC EX OFFICIOS.
DR. TARA SCHWETZ.
>> HI, I'M THE NIH DEPUTY
DIRECTOR FOR PROGRAM
COORDINATION, PLANNING AND
STRATEGIC INITIATIVES.
>> DR. JULIE.
>> I'M JULIE THE DIRECTOR OF THE
U.S. MILITARY HIV RESEARCH
PROGRAM AT THE WALTER REED.
>> DR. ROHAN.
>> HI, I'M A PEDIATRIC DISEASE
FISSION AND DIRECTOR OF THE
DIVISION OF EXTRAMURAL RESEARCH
AT NICHD AND I HAVE THE HONOR
AND PRIVILEGE OF HELPING TO TAKE
CARE OF -- WHEN SHE WAS HERE AT
OUR NIH CLINICAL CENTER.
SO REALLY A BIG LOSS FOR THE
PEDIATRIC HIV COMMUNITY.
THANK YOU.
>> AND REAR ADMIRAL JONATHAN
MERMAN.
NO?
OKAY.
WE'LL MOVE -- MAYBE HE WILL JOIN
US LATER.
WE ARE MOVING TO THE ADVISORY
COUNCIL REPRESENTATIVES.
DR. MONICA GANDHI.
>> HI, I'M MONICA, PROFESSOR OF
MEDICINE AT UCSF AND THE
DIRECTOR OF OUR C FAR AND ALSO
OF OUR WARD 86 HIV CLINIC.
THANK YOU.
>> DR. MARGARITA.
>> HELLO.
I'M MARGARITA.
I SERVE AS THE REPRESENTATIVE
FOR NIMH COUNCIL, PROFESSOR AND
ASSOCIATE DEAN FOR RESEARCH AND
DOCTORAL PROGRAMS AT THE SCHOOL
OF PUBLIC HEALTH.
>> AND DR. MELANIE ON THE WILL
BE JOINING US LATER -- OTT.
THE OAR LEADERSHIP AND SPEAKERS.
WE HAVE A FINS FINS.
>> GOOD MORNING.
I'M DEANNA FINSY, THE ACTING
ASSOCIATE DIRECTOR OF AIDS
RESEARCH AND ACTING DIRECTOR OF
THE OFFICE OF AIDS RESEARCH AT
THE NIH.
>> TIMOTHY HOLTZ.
>> I'M A MEDICAL OFFICER WITH
THE U.S. PUBLIC HEALTH SERVICE
AND AT NIH.
>> CAPTAN MARRY GLENN SHAW.
>> MARY GLENSHAW, I LEAD THE
SCIENCE GROUP HERE AT THE NIH
OFFICE OF AIDS RESEARCH.
>> DR. RACHEL ANDERSON.
>> I'M THE SENIOR POLICY ADVISOR
AT OAR.
>> AND Ms. CORETTE BYRD.
>> CORETA WILL BE JOINING US
LATER.
>> THANK YOU.
I'D LIKE TO TAKE THIS
OPPORTUNITY TO GIVE DR. SLEETS
MAN A FEW MOMENTS.
HE HAS A STATEMENT HE WOULD LIKE
TO HAVE READ INTO THE MINUTES.
>> THANK YOU, IVY AND I WON'T
READ THE WHOLE STATEMENT FOR THE
PURPOSE OF REVITY.
I WOULD LIKE TO THANK THE OFFICE
OF THE DIRECTOR OF THE NIH AND
THE OAR FOR ALLOWING ME TO SERVE
ON THE ADVISORY COMMITTEE.
THIS WILL BE MY LAST MEETING.
OVER THE PAST FOUR YEARS IT'S
BEEN AN HONOR TO BE PART OF
THIS.
I WANTED TO GO BACK TO
PRESENTATION THAT TIM HAD FOR US
A FEW MEETINGS AGO WHERE HE
TALKED ABOUT THE INCEPTION OF
THE OARAC AND OAR AND WE LEARNED
ABOUT HOW THIS PARTICULAR OFFICE
HAD BEEN THE TEMPLATE FOR FUTURE
INITIATIVES FOR NIH TO ADDRESS
THE NATIONAL AND GLOBAL HEALTH
CRISIS AND TO THAT EXTENT, I
THINK THE OAR HAS BEEN EXTREMELY
SUCCESSFUL.
THE REASON FOR MY COMMENTS TODAY
IS I WANTED TO RECOGNIZE AND
APPRECIATE THE INCREDIBLE
LEADERSHIP OF MAUREEN.
HER GUIDANCE AS THE DIRECTOR
FORMULATED OUR CURRENT FIVE-YEAR
STRATEGIC PLAN.
SHE ENGAGED IN COMMUNITY
STAKEHOLDER DIRECTLY, LISTENING
SESSIONS AND ENHANCED DIVERSITY
OF INCLUSION WITHIN THE HIV
RESEARCH COMMUNITY.
SHE ENCOURAGED PARTNERSHIPS WITH
INSTITUTES THAT PREVIOUSLY HAD
NOT BEEN GREATLY INVOLVED IN THE
HIV RESEARCH AGENDA SUCH AS
NATIONAL INSTITUTE ON AGING.
AND EXPERTISE INVOLVED IN
EXAMINING THE CO-MORBIDITIES
ASSOCIATED WITH PEOPLE LIVING
WITH HIV AS THEY AGE UP.
IN THIS REGARD, I THINK OAR IS
IN A VERY GOOD PLACE.
I SEE THIS AS A CRITICAL TIME
FOR AIDS RESEARCH BECAUSE OAR
HADS BEEN WITHOUT A PERMANENT
DIRECTOR FOR OVER A YEAR, NOW IN
OUR SECOND INTERIM LEADERSHIP.
I'M CONCERNED THAT SPECIAL
INTERESTS WITH NO CONSTITUENCY
WILL BE ABLE TO INFLUENCE THE
HIV AGENDA WITHOUT STRONG
LEADERSHIP AND PERMANENT
LEADERSHIP.
I'M ALSO CONCERNED ABOUT SMALL
INSTITUTES THAT THE CRITICAL HIV
RESEARCH AND HOPE THAT LARGER
INSTITUTES DO NOT DIVERT THE
FUNDING FROM THESE CRITICAL
MISSIONS.
SO WITH THAT REGARD, I'D LIKE TO
THANK DR. MAUREEN GOODENOW FOR
HER RESEARCH AND I HOPE WE HAVE
A NEW LEADER COMING SOON TO
PRESERVE HER LEGACY.
THANK YOU.
>> THANK YOU VERY MUCH, JOHN.
AS A REMINDER TO EVERYONE, PER
OUR CHARTER AND LEGISLATION, THE
OARAC ADVISES THE OAR DIRECTOR
ONBOARD MATTERS RELATING TO HIV
RESEARCH POLICIES, PRIORITIES
AND STRATEGIC PLANNING,
INCLUDING THE REVIEW OF NIH,
HIV/AIDS PROGRAM.
I WILL NOW PROVIDE A BRIEF
OVERVIEW OF TODAY'S AGENDA,
WHICH INCLUDES A REPORT FROM
DR. MARY GLENSHAW AND RACHEL
ANDERSON ON THE NIH STRATEGIC
PLAN FOR HIV AND HIV-RELATED
RESEARCH.
UPDATES FROM NIH ADVISORY
COUNCIL AND FINALLY UPDATES FROM
THE OARAC HIV CLINICAL
GUIDELINES.
THE AGENDA ALSO INCLUDES TIME
FOR REGISTERED PUBLIC COMMENT.
ANYONE LISTENING IN TODAY WHO
WISHES TO MAKE A PUBLIC COMMENT
SHOULD E-MAIL OARAC INFO@NIH GOV
WITH YOUR NAME, AFFILIATION AND
QUESTION OR COMMENT.
PLEASE VISIT THE NIH OAR WEBSITE
FOR THE FEDERAL REGISTER NOTICE
FOR MORE DETAIL.
BEFORE DR. FINSY PROVIDES THE
DIRECTOR'S REPORT, WE WILL HEAR
A FEW WORDS FROM THE NIH DEPUTY
DIRECTOR OF PROGRAM
COMMUNICATION, PLANNING AND
STRATEGIC INITIATIVES.
WELCOME.
>> HI, EVERYONE.
GOOD AFTERNOON OR GOOD MORNING,
DEPENDING ON WHERE YOU ARE.
I'M REALLY DELIGHTED TO BE HERE
TO JOIN YOU ALL TODAY.
I DO WANT TO TAKE JUST A MOMENT
TO WELCOME DR. IVY TURNBULL IN
HER FIRST MEETING AS OFFICIAL
OARAC CHAIRPERSON.
CONGRATULATIONS AND WELCOME.
AND ALSO, DEANNA FINSY IN HER
FIRST MEETING AS THE ACTING
DIRECTOR OF THE OAR.
I'M DELIGHTED TO HAVE BOTH OF
YOU IN THESE ROLES.
I KNOW IT WAS MENTIONED A FEW
MOMENTS AGO SOMETHING ABOUT THE
ACTING LEADERSHIP OF OAR.
I JUST JOINED IN THIS POSITION
AT NIH, SHIFTED INTO THIS ROLE
ABOUT THREE MONTHS AGO AND I CAN
TELL YOU I'M VERY COMMITTED TO
FINDING PERMANENT LEADERSHIP FOR
THIS AND THE SEARCH IS
PROGRESSING.
AND WE HOPE TO BE ABLE TO HONE
IN ON THE NEXT PERMANENT
LEADERSHIP VERY SOON.
SO JUST TO CLARIFY THAT PIECE
AND GIVE YOU THAT UPDATE.
SPEAKING OF ACTING, SO I WOULD
LIKE TO THANK DR. BILL, WHO LEFT
THE ACTING ROLE AFTER ACCEPTING
A NEW POSITION AT HHS BACK IN
DECEMBER.
GRATEFUL TO HIM FOR HIS
DEDICATED EFFORTS IN LEAD CAN
OAR FOR MUCH OF LAST YEAR.
AND I ALSO LIKE TO THANK
DR. TIMOTHY HOLTZ FOR HIS
CONTRIBUTIONS FOR DEPUTY
DIRECTOR OF OARAC AS HE IS
RETIRING FROM THE PUBLIC HEALTH
SERVICE IN A MONTH OR SO.
NOW, AS I MENTIONED, I HAVE BEEN
IN MY CURRENT ROLE FOR ABOUT
THREE MONTHS AT THE NIH --
DEPUTY DIRECTOR FOR PROGRAM
PLANNING AND STRATEGIC
INITIATIVES.
I SERVICE AS THE DIRECTOR OF THE
DIVISION AS WELL.
AND THAT'S WHERE OAR SITS AND
REALLY HAS EVOLVED OVER TIME TO
HELP IDENTIFY AND ADDRESS THOSE
KNOWLEDGE GAPS AND TO IDENTIFY
EMERGING SCIENTIFIC
OPPORTUNITIES IN THE AREA OF
HIV/AIDS RESEARCH.
NOW, NOWHERE IS THE VALUE OF THE
IMPACT OF THIS NIH-WIDE
COORDINATION BECAUSE THAT REALLY
IS THE BREAD AND BUTTER OF WHAT
WE DO IN DEPI KIPSY IS THAT
COORDINATION, AND NOWHERE IS IT
MORE EVIDENCE OR IMPACTFUL THAN
IN THE AREA OF HIV RESEARCH.
THE BREATH AND THE DEPTH OF HIV
RESEARCH FUNDED AND CONDUCTED BY
NIH IS TRULY INCREDIBLE.
AND NIH PROVIDES THE LARGEST
PUBLIC INVESTMENT IN HIV
RESEARCH IN THE WORLD WITH MORE
THAN 3500 PROJECTS AND 96
COUNTRIES.
AND THE SPANS EVERY AREA OF
MEDICINE AND SCIENTIFIC
INVESTIGATION FROM BASIC SCIENCE
TO IMPLEMENTATION RESEARCH AND
BEYOND.
I'M SURE YOU ALL ARE MUCH MORE
AWARE OF ALL OF THE DIFFERENT
TYPE OF WORK THAT YOU AND I HAVE
IN OAR AND NIH SUPPORTS.
AND THIS INVESTMENT REALLY HAS
YIELDED SOME GROUNDBREAKING
RESEARCH ADVANCES IN THE AREAS
OF TREATMENT PREVENTION AND
CARE.
AND THE BRICK THROUGHS ARE
HELPING TO PREVENT THE HIV
TRANSMISSION, TO HALT HIV
DISEASE PROGRESSION, PROTECT
SEXUAL PARTNERS AND PERSONS WHO
USE DRUGS FROM HIV TRANSMISSION
AND I THINK IMPORTANTLY, AS WELL
ENABLE PEOPLE WITH HIV TO LIVE
HEALTHIER AND LONGER LIVES.
AND WE ARE SEEING THIS NOW IN
THAT THE ISSUE OF HIV AND AGING
IS BECOMING MORE AND MORE
PROMINENT.
THE IMPACT OF THE HIV RESEARCH
PROGRAM HAS ALSO EXTENDED FAR
BEYOND THE FIELD OF HIV ITSELF.
I MEAN, I THINK SO I SPENT TIME
WORKING AT NIAID AND DR. FAUCI
AND I WROTE A COMMENTARY ON THIS
EXACT TOPIC SEVERAL YEARS AGO.
IT'S AMAZING SOME OF THE STUFF
THAT WE HAVE BEEN ABLE TO LEARN
FROM THE WORK OF HIV.
AND WE SAW THIS MOST RECENTLY IN
THE RESPONSE TO THE COVID-19
PANDEMIC WHERE HIV RESEARCH
NETWORKS AND PLATFORMS HELPED TO
ENABLE RAPID DEVELOPMENT OF
TESTING COVID AND TREATMENTS AND
VACCINES.
BUT WE KNOW THAT DESPITE ALL OF
THE ADVANCES THAT HAVE BEEN MADE
OVER THE LAST SEVERAL DECADES, A
LOT OF WORK REMAINS.
THERE ARE KNOWLEDGE GAPS THAT
PERSIST AND THERE IS A CRITICAL
NEED FOR CONTINUED AND EXPANDED
RESEARCH INVESTMENTS IN BASIC
SCIENCE, IN LONGER-LASTING
PROVISION OPTIONS, TREATMENTS,
VACCINE, A CURE AND THE
AGING-RELATED ISSUES I MENTIONED
EARLIER.
AND THIS WORK REQUIRES THAT WE
CONTINUE TO LEVERAGE THE BREADTH
AND DEPTH OF EXPERTISE ACROSS
ALL OF THE INSTITUTES AND
CENTERS AND OFFICES WITHIN NIH.
AND THAT'S WHY THIS ESSENTIAL
WORK OF OFFICE OF AIDS RESEARCH
COMES IN BUT IT'S ALSO WHERE I
THINK YOU ALL PROVIDE A REALLY
GREAT OPPORTUNITY TO HELP US AND
ADVISE US AND GIVE FEEDBACK ON
THE WORK THAT WE'RE DOING ACROSS
NIH.
SO AS YOU KNOW, OAR IS THE
COORDINATING FORCE BEHIND THE
HIV-RELATED SCIENCE THAT DRIVES
INNOVATION AND HELPS IMPROVE
PUBLIC POLICY AND ALSO WORKS TO
ACHIEVE GLOBAL HEALTH SECURITY.
AND LIKE ALL THE OTHER -- MOST
OF THE OTHER OFFICES, OAR WORKS
TO MOVE RESEARCH FORWARD IN NEW
AND SIGNIFICANT WAYS TO HELP
EXPAND AND FORM AND DEVELOP NEW
PARTNERSHIPS AND NEW APPROACHES.
AND ENGAGE EXTERNALLY TO ADDRESS
COMMUNITY NEEDS AND CONCERNS.
OAR ALSO HAS A LOT OF UNIQUE
AUTHORITIES THAT IT CAN LEVERAGE
TO HELP MANAGE THE NIH HIV
ENTERPRISE.
AND ITS EFFORTS, FACILITATE A
UNIFIED RESEARCH APPROACH TO
ADDRESS THE GLOBAL HIV PANDEMIC.
AND THAT'S MADE POSSIBLE IN PART
BY ENGAGEMENT WITH ALL OF YOU
WHO ARE MEMBERS OF THIS COUNCIL.
THROUGHOUT YOUR TENURE, AS OARAC
MEMBERS, WE REALLY LOOK FORWARD
TO YOUR EXPERT INPUT ON HIV
RESEARCH PRIORITIES.
YOUR THOUGHTFUL FEEDBACK ON THE
WORK OF OAR AND THE QUESTIONS
THAT YOU RAISE AND THAT YOU CAN
HELP US TO ASK BY HELPING US
REFINE OUR THINKING AND IDENTIFY
OPPORTUNITIES TO IMPROVE OUR
EFFORTS.
THAT FEEDBACK WE TAKE TO HEART
AND USE THAT TO HELP SHAPE SOME
OF THE WORK THAT WE'RE DOING.
SO, I WILL WRAP UP TODAY.
I KNOW YOU'RE GOING TO HEAR
ABOUT CURRENT AND UPCOMING
ACTIVITY TO ESTABLISH RESEARCH
PRIORITIES AND HELP DEVELOP THE
NEXT NIH STRATEGIC PLAN FOR HIV
AND HIV-RELATED RESEARCH.
AND AS PART OF THIS REALLY
CRITICAL PROCESS, OAR HAS ISSUED
A REQUEST FOR INFORMATION TO
GATHER UP PUT FROM EVERYONE IN
THE COMMUNITY ON THE FRAMEWORK
THAT THEY OUTLINED FOR THE
STRATEGIC PLAN AND SPECIFIC
RESEARCH PRIORITIES.
SO, I'D LIKE TO ASK THAT YOU ALL
SHARE YOUR INPUT AND HELP
DISTRIBUTE THE INFORMATION ABOUT
THIS RFI ACROSS YOUR NETWORKS TO
BE SURE THAT THE NEXT STRATEGIC
PLAN WAS REALLY INFORMED BY
BROAD AND DEEP INPUT, FEEDBACK,
EXPERTISE, ACROSS THE RESEARCH
COMMUNITY.
SO JUST WANTED TO FLAG THAT RFI
IS BEING REALLY IMPORTANT
MECHANISM FOR HARNESSING INPUT.
NOW, WITH THAT, I WILL THANK YOU
FOR YOUR TIME TODAY AND THANK
YOU SO, SO MUCH FOR YOUR SERVICE
ON THIS ADVISORY COUNCIL TO HELP
SUPPORT THE WORK THAT WE DO HERE
AT NIH AND OAR.
AND NOW I WILL TURN THE
MICROPHONE BACK OVER TO DR. IVY
TURNBULL.
>> THANK YOU VERY MUCH FOR THE
WELCOMING REMARKS.
I WILL NOW TURN THE FOCUS TO
DR. JESSI A FINN DIANA FINZI WHL
PROVIDE THE DIRECTOR'S REPORT.
>> THANK YOU.
WELCOME, EVERYONE TO THIS
65th OARAC MEETING AND THANK
YOU VERY MUCH FOR JOINING US
TODAY.
AND THANK YOU TARA FOR YOUR
VERY, VERY THOUGHTFUL REMARKS.
OAR LOOKS FORWARD TO CONTINUING
OUR WORK WITH YOU.
MY REPORT TODAY WILL COVER
LEADERSHIP TRANSITIONS AT THE
OAR AND NIH LEVELS, OARAC MEMBER
UPDATES, OAR SIGNATURE PROGRAMS
AS WELL AS RECENT AND UPCOMING
OAR ENGAGEMENTS AND THE ROLE OF
OAR, OARAC AND THE NEXT
ITERATION OF THE NIH STRATEGIC
PLAN FOR HIV AND HIV-RELATED
RESEARCH.
SO, WITH REGARD TO TRANSITIONS
AT OAR AND AT NIH, AS YOU MAY
KNOW, EFFECTIVE DECEMBER 17 OF
2023, I ASSUMED THE POSITION OF
NIH ACTING ASSOCIATE DIRECTOR
FOR AIDS RESEARCH AND ACTING
DIRECTOR OF OAR WHILE A
NATIONWIDE SEARCH FOR THE NEW
PERMANENT DIRECTOR CONCLUDES.
MANY, MANY THANKS TO DR. BILL
WHO SKILLFULLY HELD THESE
POSITIONS FOR MOST OF 2023.
BILL MOVED TO A NEW POSITION IN
THE BIOMEDICAL ADVANCED RESEARCH
AND DEVELOPMENT AUTHORITY,
OTHERWISE KNOWN AS BARDA, WITHIN
THE HHS ADMINISTRATION FOR
STRATEGIC PREPAREDNESS AND
RESEARCH.
AND WHILE AT OAR, I SERVE AS THE
DIRECTOR OF THE BASIC SCIENCES
PROVISION.
I HAVE BEEN AT NIAID FOR OVER 20
YEARS AND AN IMMUNOLOGIST BY
TRAINING.
MY ENTIRE CAREER HAS BEEN
FOCUSED ON HIV.
ITS INTERACTIONS WITH THE IMMUNE
SYSTEM AND THE PROBLEM OF VIRAL
PERSISTENCE OF HIV IN
LATENTLY-INFECTED CD4 CELLS IN
TREATED INDIVIDUALS.
I ALSO HAVE A MASTER'S DEGREE IN
PUBLIC HEALTH.
AND A TRUE INTEREST IN
TRANSLATING BASIC SCIENCE OF HIV
TO BETTER HEALTH OUTCOMES TO ALL
WHO ARE AFFECTED BY HIV.
THERE IS MORE INFORMATION ON MY
BACKGROUND AND ON THIS
TRANSITION ON OUR OAR WEBSITE.
SO NOW -- OARAC DESIGNATED
FEDERAL OFFICIAL OR DFO, IS
RETIRING FROM THE U.S. PUBLIC
HEALTH SERVICE AND THAT WILL BE
EFFECTIVE ON MARCH 31.
TIM WILL BE LEAVING HIS POSITION
AT OAR AS DEPUTY DIRECTOR AND
WILL BE MOVING TO THE NEXT STEP
IN HIS CAREER IN GLOBAL PUBLIC
HEALTH AS A CIVILIAN.
ON BEHALF OF OAR AND THE NIH,
I'D LIKE TO THANK TIM FOR HIS
OUT STABBING COMMITMENT AND
SERVICE TO OAR AND THE NIH-HIV
RESEARCH PROGRAM.
AND FOR SERVING AS OARAC DFO.
PLEASE JOIN ME IN WISHING HIM
WELL IN HIS NEW POSITION.
WHILE THE NIH CONDUCTS A
PERMANENT OAR DEPUTY DIRECTOR,
MARY GLENSHAW, SENIOR SCIENCE
ADVISER WILL SERVE AS ACTING OAR
DEPUTY DIRECTOR AND AS THE OARAC
DFO.
OARAC MEMBERS WILL RECALL THAT
MARRY SERVED AS OARAC DFO PRIOR
TO DR. HOLTZ.
THANK YOU AGAIN TIM FOR YOUR
SERVICE AND THANK YOU MARY FOR
YOUR WILLINGNESS TO TAKE ON
THESE RESPONSIBILITIES.
SO IN ADDITION TO TARA'S NEW
ROLE, THERE ARE TWO OTHER NIH
LEADERS I WOULD LIKE TO
HIGHLIGHT WHO HAVE TRANSITIONED
INTO NEW POSITIONS.
ON DECEMBER 18 OF 2023, KIM
STARTED AS THE 17th DIRECTOR
OF THE NATIONAL CANCER
INSTITUTE.
SHE CAME TO NCI FROM VANDERBILT
UNIVERSITY MEDICAL CENTER AND IS
A RENOWNED KIDNEY CANCER EXPERT
AND AN INFLUENTIAL LEADER IN
CANCER RESEARCH AS WELL AS IN
PATIENT CARE.
DR. ROTH MEL WAS SELECTED BY
PRESIDENT BIDEN TO SUCCEED
DR. MARTIN WHO LEFT THE POSITION
TO BECOME THE NIH DIRECTOR ON
NOVEMBER 9 OF 2023.
DR. MONICA BERTAGNOLLI IS THE
FIRST SERGEANT AND THE SECOND
WOMAN TO HOLD THIS POSITION.
BEFORE JOINING NCI, SHE
SPECIALIZED IN TREATING AND
RESEARCHING GI CANCERS IN HER
ROLE AS THE PROFESSOR OF SURGERY
AT HARVARD MEDICAL SCHOOL AND
SURGEON AT BRING AM AND WOMEN'S
HOSPITAL AS WELL AS MEMBERS OF
THE GI CANCER TREATMENT AND
SARCOMA CENTERS AT DANA-FARBER
CANCER INSTITUTE.
SO NOW I'D LIKE TO PROVIDE SOME
UPDATES REGARDING COUNCIL
MEMBERS.
OUR AD-HOC OARAC MEMBERS IN
ATTENDANCE INTRODUCED THEMSELVES
AT THE BEGINNING OF OUR MEETING
TODAY.
BUT I'D LIKE TO FORMERLY
RECOGNIZE AND WELCOME THEM HERE.
DR.S COURTNEY FLETCHER, SONIA
FLORES, ANNA, DIANE SANTA MARIA
AND SARAH SAWYER.
THANK YOU FOR SERVING ON OARAC
AND WE REALLY LOOK FORWARD TO
YOUR CONTRIBUTIONS.
WE'LL HAVE MORE FORMAL
INTRODUCTIONS WHEN THEY BECOME
FULL VOTING MEMBERS.
AND TO HAVE AFTER SOME DELAYS,
WE ARE VERY, VERY EXCITED AND
HAPPY TO BE ABLE TO OFFICIALLY
RECOGNIZE DR. IVY TURNBULL AS
OAR CHAIRPERSON.
SHE IS THE DEPUTY EXECUTIVE
DIRECTOR AT THE AIDS ALLIANCE
FOR WOMEN AND CHILDREN, YOUTH
AND FAMILIES.
DR. IVY TURNBULL, THANK YOU FOR
YOUR PATIENCE AND THANK YOU FOR
TAKING ON THIS RESPONSIBILITY.
WE LOOK FORWARD TO YOUR
CONTINUED SUPPORT.
AND I ALSO LIKE TO THANK THE
FOLLOWING MEMBERS WHO HAVE
COMPLETED THEIR TURNS AND HERE
FOR THEIR LAST MEETING.
MILLER, RIVERA AND JOHN
SLEASMAN.
COLLEAGUES, THANK YOU FOR YOUR
SERVICE AS OARAC MEMBERS.
WE WILL CONTINUE TO STAY
CONNECTED THROUGH OUR OARAC
WORK.
AND ONE FINAL ITEM REGARDING
COUNCIL.
DR. MONICA GANDHI HAS BEEN
SERVING AS OUR REPRESENTATIVE
FROM THE NIAID NATIONAL ADVISORY
ALLERGY AND INFECTIOUS DISEASES
COUNCIL FOR THREE YEARS AND SHE
IS NOW ROTATING OFF.
WE WELCOME DR. ABRAMS AS THE NEW
COUNCIL REPRESENTATIVE TO OARAC.
WE VERY MUCH APPRECIATE THE
VALUE THAT OUR ADVISORY COUNCIL
REPRESENTATIVES BRING TO THE
COUNCIL AND THANK THEM FOR
BRINGING ITEMS OF INTEREST FROM
THE ICs THEY REPRESENT TO
OARAC AND FOR SHARING IMPORTANT
OARAC UPDATES WITH THEIR ICs.
SO, NOW I'D LIKE TO SHARE SOME
INFORMATION ON TWO RECENT NIH
OAR ENGAGEMENT AND THE PREVIEW
SOME ACTIVITY TAKING PLACE
BEFORE OUR NEXT MEETING IN JUNE.
MANY OF OAR'S ENGAGEMENTS ARE
DRIVEN DRIVEN BY OUR SIGNATURE
PROGRAMS.
YOU HEARD ABOUT THESE AT PRIOR
OARAC MEETINGS.
THESE SIGNATURE PROGRAMS HAVE
LAST NOVEMBER THE OAR SIGNATURE
PROGRAM ON TECHNOLOGY ADVANCES
ORGANIZED AND HELD A TWO-DAY
COMMUNITY ORIENTED WORKSHOP
FOCUSED ON ADVANCING THE
DEVELOPMENT OF HIV TESTING
TECHNOLOGIES.
THE WORKSHOP'S AGENDA WAS
DEVELOPED IN PARTNERSHIP WITH
THE PREVENTION ACCESS CAMPAIGN.
REGULATORY PARTNERS AND
LEVERAGED THE MOMENTUM GAINED
THROUGH RADx TO PUSH FOR THE
DEVELOPMENT OF BETTER
DIAGNOSTICS AND VIRAL LOAD
MONITORING TESTS AT POINT OF
CARE OR PARTICIPANTS AGREED THAT
ACCESS TO -- AFFORDABLE TESTING
IN VIRAL LOAD MONITORING IS
CRITICAL FOR SUSTAINING THE
SUCCESSFUL, UNDETECTABLE,
UNTRANSMITTABLE CAMPAIGN.
ADDITIONAL INFORMATION IS
AVAILABLE ON OUR WEBSITE.
DECEMBER ONE, 2023, MARKED THE
35th OBSERVANCE OF WORLD
AIDS DAY.
OBSERVANCE OF WORLD AIDS DAY
WITHIN AN EVENT ENTITLED,
ACHIEVING EXCELLENCE AND EQUITY
IN HIV RESEARCH.
THE PROGRAM FEATURED AN UPDATE
ON THE HIV/AIDS STRATEGY FROM
Mr. PHILLIPS AND PERSPECTIVES
FROM DR. BILL AND NIAID
DIRECTOR.
OAR WILL CONTINUE PRIORITIZING
OF COLLUSION OF WOMEN IN
PREVENTION, TREATMENT AND CURE
AS AN ESSENTIAL COMPONENT OF
ENDING THE HIV EPIDEMIC.
AND THEN ON APRIL 24, OAR WILL
HOST ITS THIRD ANNUAL VIRTUAL
WORKSHOP FOR EARLY CAREER
INVESTIGATORS.
WE ANTICIPATE ANOTHER GREAT --
ANOTHER GREAT OUTCOME THIS YEAR
AND LOOK FORWARD TO SHARING NEW
DATA REGARDING THE USEFULNESS OF
THIS RESOURCE.
AND I WILL ADD THAT WE ALREADY
HAVE ABOUT 500 PEOPLE REGISTERED
FOR THIS WORKSHOP.
PLEASE CHECK OUR WEBSITE FOR
ADDITIONAL INFORMATION ON THESE
KEY OPPORTUNITIES TO PARTICIPATE
IN ALL OF THESE UPCOMING OAR
ENGAGEMENTS.
AND NOW, I'LL BRIEFLY DISCUSS
THE ROLE OF OAR ANDO RACK AS
WELL AS OUR PLANS FOR THE NEXT
ITERATION OF THE NIH STRATEGIC
PLAN FOR HIV AND HIV-RELATED
RESEARCH.
FOLLOWING MY PRESENTATION,
CAPTAN MARY GLENSHAW AND OAR
SENIOR POLICY ADVISOR,
DR. RACHEL ANDERSON WILL PROVIDE
OVERVIEW OF THE PROCESS TO
DEVELOP THE PLAN AND SHARE NEW
PROPOSED FRAMEWORKS FOR HIV
RESEARCH PRIORITIES.
THEY'LL OUTLINE NEXT STEPS AND
DESCRIBE THE ROLE OFO RACK IN
SUPPORTING THIS ACTIVITY.
THIS IS AN IMPORTANT TIME FOR
OAR AND WE REALLY DO WELCOME
YOUR ADVICE.
SO, FOR A LITTLE BACKGROUND, OAR
WAS CREATED BY CONGRESS IN 1988
AND HAD ITS MANDATE EXPANDED IN
1993.
THE OFFICE AS YOU HEARD FROM
TARA, AUTHORIZED TO ESTABLISH
HIV RESEARCH PRIORITIES, TO
ENSURE NIH AND HIV/AIDS RESEARCH
IS DIRECTED AT THE HIGHEST
PRIORITY RESEARCH AREAS,
DISSEMINATE INFORMATION ABOUT
THE RESEARCH PORTFOLIO TO THE
PUBLIC AND OVERSEE, COORDINATE
AND MANAGE ALL NIH HIV RESEARCH
ACROSS NIH INSTITUTES, CENTERS
AND OFFICES CONDUCTING HIV
RESEARCH.
SO NOW FOCUSING FOR JUST A
MOMENT ON COORDINATION AND
MANAGEMENT AS WELL AS THE NUMBER
OF INSTITUTES, CENTERS AND
OFFICES INVOLVED IN NIH HIV
RESEARCH.
IT'S EVIDENT THAT LIKE AN
ORCHESTRA, EVERY MEMBER PLAYS A
CRITICAL ROLE.
THE NUMBER OF INSTITUTES,
CENTERS AND OFFICES REFLECTS THE
COMPLEXITY OF THIS DISEASE.
AND NOW WITH THIS SLIDE, I WANT
TO SHARE JUST ONE EXAMPLE OF THE
GREAT BREADTH AND SCOPE OF NIH
HIV RESEARCH.
AND HOW INSTITUTES MAY COME
TOGETHER TO ACHIEVE A COMMON
GOAL.
I WILL USE ACRONYMS TO REFER TO
THE INSTITUTES AS I'M TRYING TO
MAKE THE POINT THAT MANY
INSTITUTES CAN BE INVOLVED AND
ARE INVOLVED IN MOVING US
FORWARD.
ON THE LEFT IS AN IMAGE OF THE
CORE STRUCTURE OF HIV.
RESEARCH ON THIS STRUCTURE
BIOLOGY FUNDED FOR MANY, MANY
YEARS BY NIGMS, RESULTED IN A
DEEP UNDERSTANDING OF HOW
INDIVIDUAL MOLECULES INTERACT
AND THEN COME TOGETHER TO FORM
THIS STRUCTURE COMPOSED OF
HEXAMERS DEPICTURED IN ORANGE
AND PENTAMERS IN YELLOW.
NIAID TOOK OVER THESE GRANTS AND
FURTHER FUNDED STUDIES ON HOW
THE INCORPORATION OF THE
PENTAMERS INTO THE STRUCTURE CAN
BE THWARTED AND THEREBY STOP THE
FORMATION OF THIS STRUCTURE AND
STOP VIRAL PRODUCTION.
A DRUG COMPANY USED THIS
FUNDAMENTAL DISCOVERY, THESE
FUNDAMENTAL DISCOVERIES TO THEN
DEVELOP A FIRST-IN CLASS OR A
FIRST OF ITS TYPE DRUG.
THIS IS A NEW DRUG THAT CAN BE
FORMULATED AS A LONG-ACTING DRUG
AND FOR VARIOUS REASONS, IT MAY
ACTUALLY TURN OUT TO BE MORE
PROMISING THAN OTHER DRUGS THAT
WE HAVE FOR PREVENTION AND
TREATMENT.
SEVERAL NIH ICOs INCLUDING
NIAID, NIDA, NICHD AND THE ORWH,
HAVE ALREADY EXPLORED THE
BENEFITS OF LONG-ACTING DRUGS OR
BIOLOGICALS SUCH AS ANTIBODIES.
THIS NEW DRUG MAY BE INVALUABLE
FOR PEOPLE WHO NEED ALTERNATIVE
OPTIONS TO A DAILY PILL OR
PERHAPS IN PREGNANT WOMEN OR IN
ADOLESCENCE OR CHILDREN.
OF COURSE, SIGNIFICANT CHALLE
CHALLENGES REMAIN, BUT IT IS THE
RESEARCH CARRIED OUT THROUGH
EACH INSTITUTE THAT WILL BE MOST
LIKELY TO BETTER THE LIVES OF
ALL PEOPLE AROUND THE WORLD
AFFECTED BY THIS VIRUS.
SO THAT WAS JUST ONE RECENT
EXAMPLE OF WHICH THERE ARE MANY.
THESE ARE NOT SIMPLE PATHWAYS.
THERE ARE CHALLENGES ALONG THE
WAY FROM BASIC BIOLOGY TO HUMAN
BEHAVIOR, FROM LOCAL STRUCTURAL
DETERMINANTS OF HEALTH TO WORLD
POLITICS.
RESEARCH FROM ACROSS THE NIH IS
CRITICAL IN HELPING PAVE THE WAY
FORWARD.
SO, IT IS WITH THIS PERSPECTIVE
THAT OAR IS DEVELOPING THE NEXT
FIVE-YEAR STRATEGIC PLAN
COVERING FY -- IT'S IMPORTANT TO
UNDERSTAND HOWO RACK FITS INTO
THIS PROCESS.
PART OF THE CHARTER, COUNCIL
MEMBERS PROVIDE GUIDANCE ON THE
PLANNING, COORDINATION AND
EVALUATION OF THE NIH HIV
RESEARCH PROGRAMS AND RELATED
ACTIVITIES.
O RACK ADVISES THE DIRECTOR
REGARDING HIV RESEARCH
PRIORITIES AND THE ON THE
DEVELOPMENT OF A COMPREHENSIVE
PLAN -- PRIOR DFO APPROVAL.
AS WE DEVELOP, THE NEXT
STRATEGIC PLAN, WE ARE REALLY AT
A CRITICAL MOMENT.
WE ARE LOOKING TO OARAC AND THE
BROADER COMMUNITY FOR INPUT AS
WE WORK TO DETERMINE PRIORITIES,
GAPS AND AREAS OF FOCUS.
THIS IS A CHALLENGE AS GREAT
PROGRESS HAS BEEN MADE BUT THERE
IS STILL MANY MAJOR GAPS THAT
PERSIST ACROSS THE ENTIRE
CONTINUUM.
THEIR IMPACTFUL DECISIONS TO BE
MADE AT THIS TIME, PARTICULARLY
GIVEN THAT WE MAY BE WORKING
WITHIN THE CONSTRAINTS OF A
LIMITED -- MORE LIMITED BUDGET.
THE EVOLUTION OF THE STATE OF
HIV SCIENCE, FOR EXAMPLE, THE
RECENT DEVELOPMENT SUCH AS THE
CONVERGENCE OF PREP AND
TREATMENT AS WELL AS NEW
LONG-ACTING FORMULATIONS, HAS
LED US TO RECONSIDER HOW TO
FRAME THE PRIORITIES MOVING
FORWARD.
THE REALITY OF INCREASINGLY
CONSTRAINED BUDGETS AND A MORE
DEFINED FEDERAL AGENDA TO END
THE HIV EPIDEMIC PROVIDE
OPPORTUNITIES EXPLORE AS WE LOOK
AT OUR PRIORITIES.
WE AIM TO INCREASE THE
EFFICIENCY BY BRINGING
INSTITUTES TOGETHER, FOSTERING A
DEEPER SENSE OF COLLABORATION
WHENEVER POSSIBLE TO INTEGRATE
AND COMPLIMENT EACH OTHER'S
WORK.
THE FY2026-2030 PLAN WILL
CONTAIN A REVISED FRAMEWORK
FOLLOWING THE HIV RESEARCH
CONTINUUM.
INCLUDING SPECIFIC RESEARCH
CAPACITY PRIORITIES.
YOU'LL HEAR MORE ABOUT THIS IN
THE NEXT PRESENTATION BUT AT A
VERY, VERY HIGH LEVEL, THE NEW
PLAN WILL ALSO FACILITATE AND
SUPPORT DATA-INFORMED
PRIORITIZATION FOR DIRECTING
CONGRESSIONALLY-APPROPRIATED NIH
HIV FUNDING.
WHILE ALSO ENABLING TRANSPARENCY
TO FOSTER EFFICIENCY AND
COLLABORATION ACROSS AND BETWEEN
NIH INSTITUTES AND CENTERS.
SO NOW MOVING FORWARD TO JUST A
FEW HOUSEKEEPING ITEMS BEFORE I
CONCLUDE.
I WANT TO REMIND COUNCIL MEMBERS
THAT OUR NEXT MEETING IS ON
THURSDAY JUNE 20, 2024 AND THAT
MEETING WILL BE HELD IN PERSON.
AS ALWAYS, THE MEETING WILL ALSO
BE VIDEOCAST SO THE PUBLIC CAN
VIEW.
I WANT TO THANK YOU FOR MAKING
THESE MEETINGS A PRIORITY IN
YOUR BUSY SCHEDULES.
THE REST OF THE AGENDA TODAY
INCLUDES THE DEEPER DIVE, WHICH
I MENTIONED, INTO THE
DEVELOPMENT OF THE NEXT
STRATEGIC PLAN, UPDATES FROM NIH
ADVISORY COUNCIL REPRESENTATIVES
TO OARAC, AND UPDATES FROM THE
HIV CLINICAL GUIDELINES WORKING
GROUPS AT OARAC.
THANK YOU ALL SO MUCH FOR YOUR
ATTENTION.
WE NOW HAVE TIME FOR SOME
QUESTIONS AND FOR SOME
DISCUSSION.
BUT I'LL ASK YOU HOLD ANY
QUESTIONS RELATED TO THE
STRATEGIC PLAN UNTIL AFTER THE
NEXT PRESENTATION.
AND, WE JUST PUT THIS SLIDE UP
AND WE'LL KEEP IT UP AS IT HAS
THE QR CODE FOR THE RFI.
THANK YOU AND BACK OVER TO YOU,
DR. TURN BULL.
>> IVY TURNBULL: THANK YOU FOR
THIS UPDATE.
WE WILL NOW HAVE TIME FOR
DISCUSSION.
BEFORE WE MOVE INTO OUR
DISCUSSION SESSION, I'D LIKE TO
ACKNOWLEDGE THAT TWO MEMBERS OF
THE OARAC EX OFFICIOS JOINED THE
MEETING AND THAT IS DR. JONATHAN
MERMIN AND -- SO OARAC MEMBERS,
PLEASE IF YOU HAVE A QUESTION OR
COMMENT, PLEASE USE THE RAISE
YOUR HAND FUNCTION SO THAT WE
CAN BEGIN OUR DISCUSSION.
IF YOU DON'T HAVE ANY QUESTIONS
OR COMMENTS -- I DON'T SEE ANY
RAISED HANDS.
WE WILL THEN MOVE --
>> DR. TURNBULL, I THINK THERE
IS A HAND UP.
>> SORRY.
>> IT'S ALL RIGHT.
I WANT TO MAKE SURE THAT WE
WELCOME DR. FINSY AS ACTING
DIRECTOR.
I THINK HER EXPERIENCE IN THIS
AREA REALLY POISES THE OARAC TO
GOOD HANDS MOVING FORWARD.
SO THANK YOU FOR ACCEPTING
TAKING THIS CHARGE.
AND I THINK IT'S REALLY AN
EXCITING TIME.
I'M LOOKING FORWARD TO THE
STRATEGIC PLAN AND TO THE
DIFFERENCE WE ARE ALL GOING TO
MAKE BECAUSE I THINK IT'S REALLY
TRANSFORMATIONAL PERIOD FOR THE
HIV RESEARCH EFFORT IN MANY
FRONTS.
AND SO I THINK THE FUTURE LOOKS
VERY GOOD FOR ADVANCEMENTS AND
FOR GUIDING THIS EFFORT FORWARD.
BUT I WANTED TO WELCOME YOU AND
THANK YOU FOR TAKING ON THIS
CHARGE.
>> THANK YOU LUIS, I REALLY
APPRECIATE IT AND I WANT TO
THANK YOU BACK FOR BEING SO
SUPPORTIVE AND SO INVOLVED IN
WORLD AIDS DAY AS WELL AS
SUPPORTING US AT OAR.
VERY MUCH APPRECIATE IT.
THANK YOU.
>> ANY OTHER COMMENTS OR
QUESTIONS?
THANK YOU, EVERYONE.
SEEING NONE, WE'LL NOW HEAR FROM
DR. MARY GLENSHAW AND DR. RACHEL
ANDERSON WHO SERVE AS OAR SENIOR
SCIENCE ADVISER AND SENIOR
POLICY VISOR, RESPECTIVELY.
DR. GLENN SHAW AND DR. ANDERSON,
PLEASE BEGIN WHEN YOU'RE READY.
>> THANK YOU AND GOOD AFTERNOON,
EVERYONE.
TODAY I'M SPEAKING WITH CAPTAN
FLOWN SHAW TO SHARE AN UPDATE ON
BEHALF OF THE NIH OAR STRATEGIC
PLAN AND NIH RESEARCH PRIORITIES
WORKING GROUP.
HERE IS A QUICK OUTLINE OF OUR
REMARKS TODAY.
WE WILL START BY PROVIDING SOME
BACKGROUND AND CONTEXT INCLUDING
A RATIONAL FOR UPDATING THE
STRATEGIC PLAN FRAMEWORK.
DESCRIBE THE UPDATED FRAMEWORK
AND PROCESS AND THEN WE'LL TALK
ABOUT THE SOURCES OF INPUT AND
NEXT STEPS AND THEN FINALLY WE
WILL DESCRIBE OARAC INVOLVEMENT
IN MORE DETAIL.
AS YOU HEARD EARLIER, OAR IS
LEGISLATIVELY MANDATED TO
DEVELOP AN UPDATED STRATEGIC
PLAN FOR HIV RESEARCH ACROSS
NIH.
BEYOND FULFILLING THE MANDATE,
THE STRATEGIC PLAN IS USED TO
SUPPORT MANY CORE FUNCTIONS OF
OAR.
THE PLAN NOT ONLY PROVIDES A
ROADMAP FOR HIV RESEARCH, IT
ALSO SERVES AS A GUIDING
FRAMEWORK FOR OAR'S EDUCATIONAL
FUNDS TO THE DIFFERENT ICOs TO
ENSURE INVESTMENT OF RESOURCES
IN THE HIGHEST SCIENTIFIC
PRIORITY AREAS.
THE PLAN ALSO INFORMS
DEVELOPMENT OF OUR TWO MAJOR
BUDGET NARRATIVE REPORTS EACH
YEAR INCLUDING THE CONGRESSIONAL
JUSTIFICATION OF THE BUDGET AS
WELL AS THE PROFESSIONAL
JUDGMENT BUDGET.
ADDITIONALLY, THE STRATEGIC PLAN
CAN SERVE AS A TOOL THAT INSURES
TRANSPARENCY.
WE SAY WHAT OUR RESEARCH
PRIORITIES ARE AND THAT'S WHAT
WE SUPPORT.
FINALLY, OUR STRATEGIC PLANNING
PROCESS IS DESIGNED TO MAXIMIZE
PARTNER INPUT.
TO PROVIDE SOME HISTORICAL
CONTEXT, I'LL BRIEFLY OUTLINE
THE RECENT HISTORY OF THE NIH
STRATEGIC PLANS FOR HIV
RESEARCH.
SINCE ISSUING THE FIRST PLAN IN
1993, OAR HAS DEVELOPED
COMPREHENSIVE RESEARCH PLAN EACH
YEAR THROUGH A COLLABORATIVE
PROCESS INVOLVING BROAD INPUT
FROM THE COMMUNITY.
UNTIL RECENTLY, THESE WERE
ANNUAL PLANS.
OLDER STRATEGIC PLANS INCLUDED A
BROAD LIST OF TOPICAL RESEARCH
AREAS OF EMPHASIS WHICH WAS
APPROPRIATE AT THE TIME WHEN
LITTLE WAS YET KNOWN ABOUT AIDS,
HIV AND HOW TO MITIGATE THE
EPIDEMIC AND DURING A TIME WHEN
THE HIV -- SORRY WHEN THE NIH
RESEARCH BUDGET DOUBLED.
THAT WAS FOR 1998-2003.
OVER TIME, THE STRUCTURE OF THE
PLANS EVOLVED TO DESCRIBE THE
BIOMEDICAL AND BEHAVIORAL
RESEARCH AND TRAINING ACTIVITIES
NEEDED TO ADDRESS THE HIV
EPIDEMIC AND TO DEFINE SPECIFIC
PRIORITIES AS THE SCIENCE AND
THE EPIDEMIC EVOLVED.
IN 2013, NIH LEADERSHIP TASKED
OARAC WITH DEVELOPING A NEW
BLUEPRINT FOR HIV RESEARCH
PRIORITIES.
PRIORITIES THAT WERE BOLD BUT
ACHIEVABLE AND SIMULTANEOUSLY
SPECIFIC AND COMPREHENSIVE.
THIS DEVELOPMENT TOOK TIME AND
ULTIMATELY RESULTED IN THE
CONCEPT OF OVERARCHING
PRIORITIES WHICH WAS FIRST
INCLUDED WITH THE FISCAL YEAR
2017 PLAN.
AS YOU CAN SEE IN THE GRAPHIC ON
THE RIGHT, THERE WERE FOUR
OVERARCHING PRIORITIES REDUCING
INCIDENCE, NEXT GENERATION
THERAPIES, CURE AND
CO-MORBIDITIES AS WELL AS
CROSSCUTTING AREAS DEPICTED IN
THE ARROW THAT SPANS ACROSS THE
AREAS.
THE FOLLOWING YEAR, THE FISCAL
YEAR 2018 PLAN INCLUDED AN
EXPANSION OF THESE CROSSCUTTING
AREAS ACROSS THE FOUR
OVERARCHING PRIORITIES.
THESE AREAS INCLUDED BASIC
RESEARCH, HEALTH DISPARITIES,
BEHAVIORAL AND SOCIAL SCIENCE
AND INFORMATION DISSEMINATION.
IN 2019, THE CURRENT VERSION OF
THESE PRIORITIES WAS PUBLISHED
IN THE NOW FAMILIAR GRAPHIC ON
THE RIGHT.
SPECIFIC AND CROSSCUTTING AREAS
WERE FURTHER REFINED.
THE FIRST FIVE-YEAR PLAN WAS
RELEASED IN 2021 AND REMAINS IN
PLACE TO THE END OF FISCAL YEAR
2025.
A FIVE-YEAR PLAN FACILITATES
LONGER-TERM PLANNING AND
RECOGNIZES THE MULTI-YEAR TIME
LINES ASSOCIATED WITH MOST NIH
SUPPORTED RESEARCH PROJECTS.
FIVE YEARS IS ALSO CONGRUENT
WITH OTHER PLANS ACROSS NIH
INCLUDING THE NIH-WIDE STRATEGIC
PLAN.
THE FOUR STRATEGIC GOALS AND
FIVE OVERARCHING PRIORITIES
FEATURED IN THE CURRENT PLAN ARE
SHOWN ON THE SLIDE HERE.
BY DESIGN, THERE IS NO DIRECT
RELATIONSHIP BETWEEN THE GOALS
AND PRIORITIES IN THIS PLAN.
AS A REMINDER, THE CURRENT
STRATEGIC GOALS ARE TO ADVANCE
RESEARCH, REMAIN FLEXIBLE AND
RESPONSIVE TO EMERGING NEEDS, TO
PROMOTE IMPLEMENTATION AND
DISSEMINATION OF RESEARCH
FINDINGS AND TO STRENGTHEN
WORKFORCE AND INFRASTRUCTURE
CAPACITY.
THE PRIORITY AREAS SHOWN HERE
AGAIN ON THE SLIDE ARE EQUALLY
BROAD.
THESE PRIORITY AREAS AS
CURRENTLY STATED REPRESENT A
COMBINATION OF TOPICAL AREAS AND
SCIENTIFIC DISCIPLINES.
DESPITE THE LABEL, THESE AREAS
DO NOT ACTUALLY ARTICULATE
SPECIFIC LEVELS OF FUNDING --
SORRY.
SPECIFIC LEVELS OF PRIORITY OF
RESEARCH AREAS.
THE REALITY OF INCREASINGLY
CONSTRAINED BUDGETS REQUIRES
PRIORITIZATION WITH GREATER
CLARITY AND SPECIFICITY.
IN 2023, OAR RECEIVED PERMISSION
FROM NIH LEADERSHIP TO REVISIT
HOW THE HIV RESEARCH PRIORITIES
ARE FRAMED WITHIN THE STRATEGIC
PLAN.
WE NOW HAVE THE OPPORTUNITY TO
REARRANGE THE STRUCTURE
SOMEWHAT, TO DIRECTLY LINK HIV
GOALS, HIV RESEARCH GOALS WITH
CORRESPONDING OBJECTIVES AND
TOPICAL PRIORITIES.
UPDATED FRAMEWORK CAN LEVERAGE
THE INCREASING INTERSECTION OF
SCIENTIFIC APPROACHES ACROSS HIV
PREVENTION, TREATMENT,
CO-MORBIDITIES AND CURE
RESEARCH.
THESE CHANGES CAN PROMOTE
INTERDISCIPLINARY INTEGRATIVE
RESEARCH AND HIGHLIGHT
POPULATIONS, SETTINGS AND
CHALLENGES THAT, MERGE AND SHIFT
OVER TIME.
IT'S IMPORTANT TO NOTE THAT THE
UPDATED FRAMEWORK WILL NOT
ELIMINATE THE CURRENT PRIORITY
AREAS BUT WILL HIGHLIGHT THESE
TOPICS DIFFERENTLY ACROSS THE
BACKDROP OF THE RESEARCH
CONTINUUM.
AS A FIRST STEP IN UPDATING THE
FRAMEWORK, OUR WORKING GROUP
ESTABLISHED FOUNDATIONAL
PRINCIPLES RELEVANT THROUGHOUT
HIV RESEARCH.
I'LL DESCRIBE THE PRINCIPLES
NOW.
RESEARCH TO IDENTIFY AND ADDRESS
HIV-RELATED HEALTH DISPARITIES
IS ESSENTIAL TO ENSURE THAT THE
BENEFITS OF SCIENTIFIC ADVANCES
REACH ALL PEOPLE UP AND
COMMUNITIES AFFECTED BY HIV,
INCLUDING GROUPS THAT
HISTORICALLY BEEN UNDER
REPRESENTED AND UNDERSERVED.
RESEARCH MUST ALSO ADDRESS THE
UNIQUE NEEDS OF PEOPLE WITH HIV
ACROSS THE LIFESPAN,
PARTICULARLY AS PEOPLE AGE WITH
THE VIRUS, INCLUDING THOSE BORN
WITH HIV.
AND FINALLY, ENGAGEMENT AND
PARTNERSHIP WITH COMMUNITIES
AFFECTED BY HIV ARE BOTH
ESSENTIAL AT EVERY STAGE OF
RESEARCH.
WE DEVELOPED THE PROPOSED
FRAMEWORK TO ALIGN WITH THE NEW
NIH COMMON TEMPLATE FOR
STRATEGIC PLANS, AN EFFORT TO
HARMONIZE STRATEGIC PLANNING
ACROSS NIH.
WE ALSO LOOKED TO THE STRUCTURE
OF THE MOST RECENT PROFESSIONAL
JUDGMENT BUDGET WHICH FOLLOW
STAGES OF THE RESEARCH
CONTINUUM.
OUR PROPOSED FRAMEWORK INCLUDES
STRATEGIC -- I'M SORRY.
OUR PROPOSED FRAMEWORK INCLUDES
RESEARCH GOALS AND THE CAPACITY
GOAL.
THE RESEARCH GOALS HAVE BEEN
SLIGHTLY MODIFIED FROM THE
STRATEGIC GOALS OUTLINED IN THE
CURRENT PLAN AND ARE AS FOLLOWS:
GOAL 1 IS TO ENHANCE DISCOVERY
AND ADVANCE HIV SCIENCE THROUGH
FUNDAMENTAL RESEARCH.
GOAL 2 IS TO ADVANCE THE
DEVELOPMENT AND ASSESSMENT OF
NOVEL INTERVENTIONS FOR HIV
PREVENTION, TREATMENT AND CURE.
GOAL 3 IS TO OPTIMIZE THE PUBLIC
HEALTH IMPACT OF HIV DISCOVERIES
THROUGH TRANSLATION,
DISSEMINATION AND IMPLEMENTATION
OF RESEARCH FINDINGS.
AND FINALLY, GOAL 4 IS TO BUILD
RESEARCH WORKFORCE AND
INFRASTRUCTURE CAPACITY TO
ENHANCE SUSTAINABILITY OF HIV
RESEARCH DISCOVERY.
NOW THIS SLIDE SHOWS YOU HOW WE
ENVISIONED THE PLAN'S STRUCTURE.
WITHIN EACH GOAL, OBJECTIVES
REFLECTING DIFFERENT RESEARCH
AREAS WILL BE IDENTIFIED.
SPECIFIC FUNDING PRIORITIES WILL
THEN BE HIGHLIGHTED WITHIN EACH
OBJECTIVE.
FUNDING PRIORITIES WILL BE
IDENTIFIED TO REFLECT BOTH
ONGOING RESEARCH AND AREAS WHERE
ADDITIONAL INVESTIGATION IS
NEEDED.
AS WELL AS EMERGING AREAS OF
RESEARCH AND NEW OPPORTUNITIES.
PLEASE NOTE THAT THE STRUCTURE
MAY BE THE SAME FOR EACH GOAL
BUT THE NUMBER OF OBJECTIVES AND
PRIORITIES PER GOAL WILL DIFFER.
TO HELP YOU ENVISION HOW SOME
RESEARCH TOPICS MIGHT FIT INTO
THE NEW FRAMEWORK, WE MAPPED OUT
A FEW EXAMPLES.
IN THE CURRENT FRAMEWORK ON THE
RIGHT, RESEARCH ON HIV AND
SUBSTANCE ABUSE CORRESPONDS WITH
THE CO-MORBIDITY AREA IN GREEN.
IN THE NEW STRUCTURE, SUBSTANCE
USE RESEARCH COULD FALL WITHIN
ANY OF THE THREE RESEARCH GOALS.
VACCINE RESEARCH WHICH
CORRESPONDS TO REDUCING
INCIDENTS, PRIORITY AREAS SHOWN
IN ORANGE, IS A SIMILAR EXAMPLE.
AS IS RESEARCH ON LONG ACTING
FORMULATIONS CURRENTLY MAPPED TO
NEXT GENERATIONS THERAPY IN
PURPLE.
CURE RESEARCH SHOWN IN RED,
WOULD LIKELY FIT WITHIN GOALS 1
AND 2 WHILE HELP COMMUNICATIONS
RESEARCH PREVIOUSLY ACROSS
CUTTING AREA WOULD FIT WITHIN
GOALS 2 AND 3.
YOU CAN ALSO SEE THE
CROSSCUTTING AREAS OF
CONSTRUCTION GRANTS AND TRAINING
GRANTS WOULD FIT UNDER GOAL 4.
AS THE SCIENCE EVOLVES, THE
POSITIONING OF THESE TOPICAL
AREAS ACROSS GOALS IS
ANTICIPATED TO SHIFT.
THIS SLIDE PROVIDES AN OVERVIEW
OF THE PROCESS TO DEVELOP THE
NEXT STRATEGIC PLAN.
WE'LL DESCRIBE EACH OF THESE
STEPS IN MORE DETAIL IN THE NEXT
SLIDES.
BUT FIRST, WE STARTED IN MID
2023 BY FORMING AN INTERNAL
WORKING GROUP THAT WAS
ESTABLISHED IN ORDER TO PROPOSE
A NEW FRAMEWORK FOR THE PLAN.
SO HERE WE ARE.
WE ARE CURRENTLY SEEKING INPUT.
WE STARTED INTERNALLY WITH OAR
SCIENCE STAFF AND MEMBERS OF THE
NIH AIDS EXECUTIVE COMMITTEE.
AND THAT'S THE COMMITTEE THAT
REPRESENTS THE INSTITUTES AND
CENTERS AND OFFICES ACROSS NIH
WITH THE RELEASE OF OUR RFI
EARLIER THIS MONTH.
WE ARE CONTINUING TO SOLICIT
INPUT INCLUDING FROM WITHIN NIH
AND FROM THE EXTERNAL COMMUNITY.
THE COLLECTIVE INPUT WILL INFORM
THE FRAMEWORK AND GENERATE
PROPOSED PRIORITIES FOR REVIEW
AND SYNTHESIS BY THE WORKING
GROUP AND WILL BE SHARED WITH
OARAC TASK FORCES.
WE WILL RELY ON TASK FORCES OF
OARAC TO PROVIDE RECOMMENDATIONS
TO THE OAR DIRECTOR.
WE'LL THEN WORK WITH THESE
REFINERIES TO WRITE THE PLAN.
THE PLAN WILL BE SHARED WITH
OARAC FOR APPROVAL BEFORE GOING
THROUGH NIH CLEARANCE AND
PUBLICATION.
NOW, I'LL HAND IT OVER TO CAPTAN
GLENN SHAW TO TELL YOU MORE
ABOUT THE SOURCES OF INPUT THAT
WILL INFORM DEVELOPMENT OF OUR
RESEARCH PRIORITIES.
>> JOE GLINIEWICZ: THANK YADRIE.
CAN EVERYONE HEAR ME OKAY?
NEXT SLIDE, PLEASE.
THERE ARE SIX FUNDAMENTAL
SOURCES OF INPUT INVOLVED IN THE
DEVELOPMENT OF THIS STRATEGIC
PLAN AS YOU CAN SEE HERE.
INTERNAL NIH SOURCES ARE SHOWN
ON THE LEFT INCLUDING OAR
SUBJECT MATTER EXPERTS AND THE
NAEC AS MENTIONED BY RACHEL.
DISCUSSIONS AND INPUT AT THESE
LEVELS LED TO THE REVISED
FRAMEWORK WE PRESENTED TODAY AND
INITIAL FEEDBACK REGARDING
OBJECTIVES AND RESEARCH
PRIORITIES.
EXTERNAL SOURCES OF SHOWN IN
BLUE ON THE RIGHT AND INCLUDE
OAR LISTENING SESSIONS,
SIGNATURE PROGRAM AND OTHER
WORKSHOPS AND PUBLIC INPUT FOR
REQUESTS FOR INFORMATION.
THESE SOURCES CAN HELP IDENTIFY
RESEARCH PRIORITIES, GAPS AND
OPPORTUNITIES AND COMMON THEMES
AMONG PARTNERS.
IMPORTANTLY, THEY ARE ALSO
OPPORTUNITIES FOR DEVELOPING NEW
PARTNERSHIPS.
FINALLY, YOU WILL SEE YOURSELF
THE OARAC, INCLUDING HHS AND NIH
LEADERSHIP AS FOUNDATIONAL AT
THE BASE OF THIS GRAPHIC.
IT IS IMPORTANT TO RECOGNIZE
THAT MUCH OF THE WORK TOWARDS
DEVELOPING THE NIH HIV STRA
TEAMIC PLAN INVOLVES TWO PRIMARY
ADVISORY COUNCIL.
OARAC AND THE NAEC.
OARAC ADVISES THE OAR DIRECTOR
IN THE PLANNING, COORDINATION
AND EVALUATION OF HIV RESEARCH
AT THE NIH.
THE COUNCIL REFLECTS NATIONAL
REPRESENTATION BY MEMBERS FROM A
WIDE RANGE OF DISCIPLINES.
THE OARAC CHARTER SPECIFICALLY
CALLS OUT STRATEGIC PLAN ADVICE
AS A CORE ROLE.
THE NAEC IS THE ADVISORY ARM AND
COORDINATING COMMITTEE FOR NIH
HIV RESEARCH EFFORTS.
MEMBERS REPRESENT ICOs WITH
HIV FUNDING.
THEY ASSIST AND ADVISE IN
COORDINATION OF PROGRAM
INITIATIVES AND INTRA-AGENCY
COORDINATION.
A FOUNDATIONAL STEP IN STRATEGIC
PLAN DEVELOPMENT IS THE INTERNAL
DISCUSSION AND ANALYSIS OF THE
HIV PORTFOLIO.
ANALYSIS ASSESS TRENDS OVER TIME
ACROSS SEVERAL FACTORS AND CAN
HELP DETERMINE GAPS AND
OPPORTUNITIES IN THE PORTFOLIO.
TOPICAL ANALYSIS SUCH AS THOSE
LISTED HERE, HELP US RESPOND TO
PARTNER AND COMMUNITY INQUIRIES,
SHAPE OUR SIGNATURE PROGRAMS AND
REFINE RESEARCH PRIORITIES.
AS PRESENTED TO THE OARAC IN
JUNE 2023, THERE ARE NEW DATA
DASHBOARDS PUBLICLY AVAILABLE ON
THE OAR WEBSITE AS SHOWN ON THE
UPPER RIGHT.
NEXT SLIDE, PLEASE.
AS PREVIOUSLY REPORTED, NIH OAR
IS HEAVILY INVOLVED IN THE
ORGANIZATION AND COORDINATION OF
LISTENING SESSIONS WITH
DIFFERENT PARTNERS.
I ENCOURAGE YOU TO SCAN THIS QR
CODE TO READ REPORTS OF
LISTENING SESSION FINDINGS, THE
MOST RECENT PUBLISHED THIS PAST
DECEMBER.
ONGOING LISTENING SESSIONS
INCLUDE ENSURING BROAD AND
INCLUSIVE INPUT FROM DIVERSE
PARTNERS AND COMMUNITIES AND
PROVIDING A FORUM TO COMMUNICATE
WITH THE NIH FROM LOCAL AND
REGIONAL PERSPECTIVES,
PARTICULARLY REGARDING RESEARCH
PRIORITIES.
TO DAYLIGHT, OAR CONDUCTED
NEARLY 60 LISTENING SESSIONS IN
20 LOCATIONS SHOWN HERE ON THE
MAP, INCLUDING MANY EAG PRIORITY
JURISDICTIONS.
LISTENING SESSIONS PRODUCED
REOCCURRING THEMES REGARDING
RESEARCH AREAS SUCH AS THOSE
LISTED HERE.
AND ACROSS CUTTING THEMES THAT
ARE RELEVANT ACROSS TOPICAL
AREAS, SUCH AS THE IMPORTANCE OF
COMMUNITY PARTNERSHIP AND
CULTURAL HUMILITY, INFORMATION
DISSEMINATION AND SUPPORT OF HIV
RESEARCH WORKFORCEFRASTRUCTURE
AND RESOURCE NEEDS.
OAR HAS RECENTLY REDOUBLED
EFFORTS IN OUR CONVENING ROLE.
IN FISCAL YEAR 2023 ALONE, OAR
LED OR CO-LED 11 WORKSHOPS OF
WHICH MANY OF WHICH SUPPORT
NIH-WIDE SIGNATURE PROGRAMS.
THESE WORKSHOPS INVOLVED OVER
1200 PARTICIPANTS REPRESENTING
DOZENS OF ORGANIZATIONS,
INSTITUTIONS, STATES, NATIONS,
POPULATIONS AND LEVELS OF TEN
TENURE.
KEY FINDING AND INPUT FROM THESE
WORKSHOPS ARE WELL DOCUMENTED IN
SUMMARIES, REPORTS, AND
PUBLICATIONS.
IN ADDITION, WE ARE IN RECEIPT
OF DATA FROM A RECENT RFI
REGARDING RESEARCH OPPORTUNITIES
RELATED TO HIV AND WOMEN'S
HEALTH CO-ISSUED BY THE OAR AND
NIH OFFICE ON RESEARCH FOR
WOMEN'S HEALTH.
INPUT FROM ALL OF THESE
ACTIVITIES WILL BE INCORPORATED
INTO THE NEXT STRATEGIC PLAN.
THE FINAL EXTERNAL SOURCE OF
INPUT IS A FORMAL OUTREACH
METHOD TO EXTERNAL PARTNERS
THROUGH AN RFI OR REQUEST FOR
INFORMATION.
THIS WEB-BASED REQUEST ENABLES
WRITTEN FEEDBACK USING ONLINE
FORUM.
YOU SEEN IT BEFORE BUT FEEL FREE
TO SCAN THE QR CODE HERE TO SEE
THE RFI ON LINE AND PLEASE
CONSIDER SHARING YOUR INPUT
BEFORE IT CLOSES ON MARCH 28.
FEEDBACK FREQUENTLY INTERESTED
CONSTITUENTS SUCH AS THOSE SHOWN
HERE ARE INVITED TO PROPOSE
RESEARCH PRIORITIES FOR GREATEST
POTENTIAL TO ADVANCE HIV SCIENCE
AND IMPACT HIV ASSOCIATED PUBLIC
HEALTH ACROSS THE FOUR RESEARCH
CAPACITY BUILDING ROLES.
WE ALSO LOVE ADDITIONAL FEEDBACK
ON THE UPDATED FRAMEWORK.
NOW WE'LL MOVE TO SPECIFIC
INFORMATION REGARD OTHER OARAC
IN THIS PROCESS.
OARAC INPUT IS ESSENTIAL TO
DEVELOP A REPRESENTATIVE AND
ROBUST STRATEGIC PLAN.
THUS, OAR WILL INITIATE SHORT
TERM MULTISECTORIAL TASK FORCES
WITH OARAC MEMBERS AND INVITED
PARTICIPANTS TO REVIEW AND
SYNTHESIZE INPUT FROM THE MANY
SOURCES DISCUSSED TODAY.
TASK FORCE PARTICIPANTS WILL ADD
THEIR OWN IMPRESSIONS AND AREAS
TO CONSIDER ALONG WITH
RECOMMENDATIONS TO THE OAR
DIRECTOR.
THESE TASK FORCES ARE CONCEIVED
TO BE SIMILAR TO THE
COORDINATING COMMITTEES THAT
SUPPORTED STRATEGIC PLAN
DEVELOPMENT IN THE PAST.
THE TASK FORCES WILL BE ASKED TO
DEVELOP CRITERIA TO CATEGORIZE
INPUT BY TYPE, SUCH AS TOPICAL
AREAS, METHODS AND APPROACHES,
AND BI-LEVEL SUCH AS HIGH,
MEDIUM AND LOW.
THE TASK FORCES WILL BE ASKED TO
ASSESS THE INPUT RECEIVED
INCLUDING ANY FROM THE TASK
FORCE MEMBERS ITSELF.
AND ESTABLISH CONSENSUS ON
PRIORITY AREAS AND DOCUMENT ANY
OUTLIERS OR AREAS THAT LACK
CONSENSUS.
AND FINALLY, REPORT THEIR
FINDINGS TO THE OAR DIRECTOR.
ON THE RIGHT YOU'LL SEE A BRIEF
PROPOSED STRUCTURE FOR HOW THESE
TASK FORCES MAY BE COMPOSED.
CO-CHAIRS INCLUDE ONE OARAC
MEMBER AND ONE NIH SME OR
SUBJECT MATTER EXPERT.
MEMBERS WOULD BE INVITED FROM
NAEC AND NON FEDERAL PARTNERS
AND REPRESENT MULTIDISCIPLINARY
EXPERTISE, INCLUDING LIVED
EXPERIENCE.
WE'LL REVIEW THE STAGES OF PLAN
DEVELOPMENT AND THE ANTICIPATED
TIMELINE.
AS YOU CAN SEE HERE, THE
PREPARATION STAGE JUST CONCLUDED
WHICH INVOLVED PERFORMING
INTERNAL WORKING GROUP AT THE
OAR, DRAFTING NEW FRAMEWORK AND
COORDINATING INTERNAL NIH INPUT.
WE ARE CURRENTLY HERE IN THE
CONVENING ENGAGING STAGE.
THIS STAGE WILL LAST THROUGH THE
CURRENT FISCAL YEAR AND INVOLVES
SIN SIZING INPUT FROM SEVERAL
SOURCES SUCH AS RFI LISTENING
SESSIONS AND STANDING UP THE
SHORT TERM MULTISECTORIAL TASK
FORCES I JUST MENTIONED.
LOOKING AHEAD, WE ANTICIPATE
RECEIVING RECOMMENDATIONS FROM
OARAC LATER THIS YEAR WHEN WE
START FORMERLY DEVELOPING THE
PLAN FOR NIH CLEARANCE.
FINAL REVIEWS MAY TAKE THE FIRST
HALF OF FISCAL YEAR 2025.
AND FINALLY, WE ARE AGING TO
PROMOTE AND LAUNCH THE NEW PLAN
NEXT SUMMER BEFORE THE START OF
FISCAL YEAR 2026.
IN CONCLUSION, WE INVITE YOUR
FEEDBACK, OVER ALL IMPRESSIONS
AND QUERIES.
ANY SPECIFIC RECOMMENDATIONS OR
FEEDBACK FOR THE SECTORS IS
WELCOME.
IDEAS ON TASK FORCE ORGANIZATION
AND THE TIMELINE WOULD ALSO BE
APPRECIATED.
RACHEL AND I WOULD ESPECIALLY
LIKE TO THANK OAR AND NIH
COLLEAGUES PARTICULARLY THE
STRATEGIC PLAN AND HIV RESEARCH
PRIORITIES WORKING GROUP FOR THE
DEVELOPMENT OF THIS PRESENTA
PRESENTATION.
THANK YOU.
>> THANK YOU DR. FLOWN SHAW AND
DR. ANDERSON.
WE NOW HAVE TIME FOR DISCUSSION.
ANY MEMBERS WHO HAVE ANY
QUESTIONS OR COMMENTS, PLEASE
REMEMBER TO USE THE RAISE HAND
FUNCTION SO I CAN SEE YOU.
>> I SEE JOHN SLEASMAN AND
OTHERS.
>> THANK YOU.
I DON'T SEE ANY OF THAT.
THANK YOU VERY MUCH.
IN THAT ORDER.
>> LADIES FIRST.
>> OKAY.
>> THANKS VERY MUCH.
DR. ANDERSON AND CAPTAN GLENN
SHAW.
CAN YOU TALK MORE ABOUT THE ROLE
AND TIMELINE OF THE PORTFOLIO
ANALYSIS COMPONENT?
AND HOW THE RESULTS OF THAT
PORTFOLIO ANALYSIS WILL EITHER
BE FOLDED INTO A REPORT OR INTO
THE SPECIFIC TASK FORCES?
THANK YOU VERY MUCH.
>> SURE, I'M HAPPY TO TAKE THAT.
THESE ANALYSIS AND REPORTS ARE
CONTINUOUS.
WE CONTINUALLY ANALYZE DIFFERENT
ASPECTS OF THE PORTFOLIO AND TRY
OUT NEW METHODOLOGIES FOR
ANALYSIS AND WE ANTICIPATE USING
THIS TOOL TO SORT OF HELP REFINE
THE INPUT THAT WE'RE GETTING SO
WE DON'T HAVE SORT OF A PRE-SET
PLAN FOR THESE NEW ANALYSIS.
IT WILL DEPEND ON THE INPUT WE
ARE GETTING.
AND ONE EXAMPLE WOULD BE IF A
PRIORITY AREA IS NOTED THAT WE
DON'T HAVE A GREAT SENSE FOR HOW
MUCH RESEARCH HAS BEEN DONE IN
THAT AREA IN THE PAST, WE COULD
LOOK AT THE LEVELS OF
INVESTMENT, TYPES OF GRANTS, THE
DIFFERENT INSTITUTES THAT FUND
THAT TYPE OF RESEARCH, HOW IT'S
GROWN OR SHRUNK OR CHANGED OVER
TIME, TO REALLY HELP DETERMINE
HOW MUCH OF A GAP THIS PRIORITY
IS.
DOES THAT HELP.
>> YES IT DOES. I WAS WONDERING
WERE THERE GAPS IDENTIFIED WHERE
THE PORTFOLIO ANALYSIS DIDN'T
NECESSARILY MAP TO THE PRIOR
STRATEGIC PLANNING?
WERE THERE ANY INSIGHTS GARNERED
FROM THAT PROCESS?
BUT IT SOUNDS LIKE THIS IS MORE
OF A TOOL TO IDENTIFY HOW
SPECIFIC AREAS ARE FUNDED BY
SPECIFIC INSTITUTES AND FUNDING.
THANKS.
>> AMONG OTHERS, YES.
AND TRULY LOOKING MORE
PROSPECTIVELY AT THIS POINT.
>> DR. JOHN SLEASMAN.
>> THANK YOU THANK YOU.
I LOVE THE SLIDES.
I DEPENDENT HEAR MUCH ABOUT
PARTNERSHIPS WITH THE OTHER
FEDERAL AGENCIES THAT ARE
INVOLVED IN HIV AND PARTICULARLY
INVOLVING THE COMMUNITY OUTREACH
SPECIFICALLY THINKING ABOUT
INTERACTIONS BETWEEN -- AS WE
START TO THINK ABOUT UNDERSERVED
POPULATIONS AND HEALTH CARE
DISPARITIES, WHICH ARE REALLY A
BIG THING FOR A LOT OF US.
ONE OTHER THING.
SO A LOT OF THE TIMES THE RFIs
HAVE ONLY BEEN ENGAGED ACADEMIC
CENTERS AND I THINK WE HAVE TO
BE CAREFUL THAT WE GET THE FULL
SCOPE OF THE PEOPLE THAT ARE
AFFECTED BY HIV AND AIDS THAT
ARE OUTSIDE OF THE ACADEMIC
CENTERS.
>> THANK YOU DR. JOHN SLEASMAN.
GREAT ADVICE.
I THINK REACHEL HAS SOME
THOUGHTS AS WELL.
>> I WANTED TO ADD THAT WE ARE
DEFINITELY ENGAGING WITH OUR
COLLEAGUES AT -- WE INCLUDED
THEM IN PART OF OUR OUTREACH AND
PROMOTIONAL PLAN FOR THIS RFI
RELEASE.
SO, WE ARE SHARING THIS REQUEST
WITH THEM AND WE ALSO ENGAGE
WITH HIV.GOV TO COORDINATE
DISTRIBUTION OF THIS REQUEST
ACROSS THE GOVERNMENT.
>> I WANTED TO REITERATE, JOHN,
RACHEL IS OUR NEWLY-PROMOTED
SUPERVISOR OF THE POLICY
LEGISLATIVE COMMUNICATIONS AND
ENGAGEMENT TEAMS.
THIS IS VERY MUCH PART OF OUR
OAR STRUCTURE.
>> THANKS.
>> THANKS AND REGARDING THE
ACADEMIC CENTERS AS WELL, WE DO
HAVE A NUMBER OF OUTREACH
OPPORTUNITIES WITH NON-ACADEMIC
PARTNERS AND WE TAKE THOSE VERY,
VERY SERIOUSLY AND WILL BE
CONTINUING THOSE.
AND WE ALSO HAVE A NUMBER OF
ONGOING FEDERAL TO FEDERAL
ENGAGEMENTS, FOR EXAMPLE, NIH
AND CDC MEET QUARTERLY TO
DISCUSS TOPICAL EVENTS AND
ACTIVITIES.
WE MEET WITH OUR PARTNERS
FREQUENTLY AS WELL.
SO WE'LL BE PROMOTING THIS
THROUGH BOTH FORMAL AND KIND OF
ROUTINE CHANNELS.
>> THANK YOU.
DR. LUIS MONTANER.
>> YES, THANK YOU.
SO I THINK THIS PLAN IS REALLY
SETS THE TONE FOR HOW WE ARE
GOING TO ENGAGE THE FOLLOWING
PRIORITIES MOVING FORWARD.
ONLY TWO POINTS.
ONE TO JUST SORT OF FOLLOW-UP ON
THE -- GETTING INPUT FROM THE
OUTSIDE AND WE TALKED ABOUT THE
ROLE OF COMMUNITY HEALTH CENTERS
AND THE NETWORKS WITHIN THESE
CLINICS THAT CARE FOR A LOT OF
INDIVIDUALS WITH HIV THAT THEIR
VOICE WILL MEET THAT ARE MORE
OPERATIONAL WILL BE REALLY
IMPORTANT TO TAKE INTO ACCOUNT.
THE RCMI NETWORKS ALSO THAT ARE
DEALING WITH ENVIRONMENTS THAT
WE WANT TO LOOK INTO IS ANOTHER
ONE.
SO I WOULD JUST ENCOURAGE YOU TO
TRY TO REACH OUT OUTSIDE OF THE
COMFORT ZONE OF ACADEMIC
STANDARDS AGGRESSIVELY.
MY SECOND POINT IS THAT WHEN IT
COMES TO STRATEGIC PLAN, WE ALL
WANT TO THINK ABOUT
OPERATIONALLY REDUCING TO VERY
SPECIFIC ACTIONS BUT OBVIOUSLY
AT THIS POINT, WE ARE TALKING
ABOUT MUCH BROADER THEMES AND
PRIORITIES.
SO I WANT TO ENCOURAGE WHEN YOU
DEFINE TASK FORCE, THAT YOU
DEFINE SOME OF THESE TASK FORCES
TO BE MORE INQUISITIVE ABOUT THE
GAPS.
LIKE FOR EXAMPLE, WE TALKED
ABOUT HOW TO REACH GREATER
COMMUNITY-BASED RESEARCH OR HOW
TO BREAKTHROUGH OUR STUDY
SECTIONS ON COMMUNITIES THAT ARE
TRYING TO DEVELOP RESEARCH
INITIATIVES BUT THEY BASICALLY
DIE ON THE STUDY SECTION.
AND THERE IS THE GOAL AND THERE
IS THE OPERATIONAL PROCESS TO
GET THE GOAL IMPLEMENTED.
AND TO THE POINT THAT THE
PRIORITIES COULD TRY TO CHIP
AWAY AT TRYING TO ACKNOWLEDGE
THAT WE DO NEED TO DO BETTER
THAN JUST GO AFTER THE TOPICS.
WE NEED TO ALSO LOOK AT THE
OPERATIONAL PROCESS BY WHICH WE
SUPPORT OUR RESEARCH STRUCTURE,
BECAUSE I THINK THAT THERE IS
SOME REALIGNMENT THAT COULD
POTENTIALLY OPEN UP FOR MORE
REPRESENTATION IN THE RESEARCH
EFFORT ACROSS-THE-BOARD AND
BY - EYE UNDERSTAND THE BARRIERS
ARE IMPORTANT BECAUSE OF THE
GOALS BUT WE ALSO HAVE TO
ACKNOWLEDGE THE PROCESS OF
GETTING THOSE GOALS IS ALSO
IMPORTANT.
SO I DON'T KNOW TO WHAT EXTENT
WE COULD INTRODUCE OPERATIONAL
RESEARCH SUPPORT,
COMMUNITY-BASED RESEARCH
OPPORTUNITIES, AND HOW THESE
PRIORITIES WILL ACKNOWLEDGE THAT
THAT IS SOMETHING THAT WE WANT
TO DO BETTER IN THE FUTURE.
>> THANKS.
IF I MAY, IT SOUNDS LIKE YOU
REALLY ARE SUPPORTING THE NOTION
OF NOT ONLY ELUCIDATING RESEARCH
PRIORITIES BUT PATHWAYS TO REACH
THOSE PRIORITIES.
>> CORRECT.
I THINK THE PATHWAY IS WHERE WE
LOSE A LOT IN THE PROCESS.
>> ABSOLUTELY.
AND JUST IF IT WASN'T CLEAR
REGARDING THE TASK FORCES, WE
WILL ABSOLUTELY BE INVITING
COMMUNITY MEMBERS, NON-ACADEMIC
COMMUNITY MEMBERS TO THESE TASK
FORCES AS WELL.
>> THANK YOU BOTH.
DR. AKE.
>> I HAD TWO COMMENTS.
ONE WAS JUST TO REALLY COMMEND
THE PRESENTATION FOR SEPARATELY
IDENTIFYING AND BY COROLLARY,
PRIORITIZING FOR RESOURCES,
EFFORTS FOR CAPACITY BUILDING,
TRAINING GRANTS IN THAT
PRESENTATION.
AND THOSE ARE REALLY IMPORTANT
EFFORTS TO SUSTAINABILITY OF HIV
RESEARCH, REALLY ACROSS THE
SPECTRUM OF THE WORK THAT IS
DONE.
AND EVEN ADDRESSING THE
DISPARITIES WITHIN THE RESEARCH
COMMUNITY, ARE GOING TO
REACQUIRE A FOCUSED ATTENTION ON
THAT VERY ISSUE.
SO I REALLY WANTED TO COMMEND
THE PRESENTATION AND EARLY PLANS
FOR CALLING THAT OUT.
THE COMMENT I'D LIKE TO MAKE
ABOUT THAT IS IT IS MOST USEFUL
WHEN THOSE CAPACITY-BUILDING
EFFORTS ARE REALLY INTEGRATED
INTO THE PRIMARY RESEARCH
EFFORTS THAT ARE DESCRIBED.
LIKE A TRAINING GRANT IS NOT
HELPFUL IF SOMEONE DOESN'T HAVE
A RESEARCH PROJECT THAT GIVES
THEM DATA OR AN ANALYSIS THAT
THEY ARE ABLE TO WORK ON FOR
THEIR TRAINING.
AND DISSERTATION.
SO, YOU MIGHT WANT TO CONSIDER
WAYS THAT YOU MIGHT BE ABLE TO
VISUALLY SHOW OR THROUGH THE
WRITING OF THE PLAN, SHOWING HOW
EACH OF THE BASIC SCIENCE TOOL
DEVELOPMENT AND IMPLEMENTATION
SCIENCE COMPONENTS OF THE
RESEARCH PILLARS COULD EACH
INCORPORATE SOME OF THOSE
CAPACITY-BUILDING
CONSIDERATIONS.
THANK YOU VERY MUCH.
>> THANK YOU.
DR. GANDHI.
>> I JUST WANT TO SAY I SO
APPRECIATE THE FOURTH GOAL BEING
ALL ABOUT CAPACITY.
I THINK THAT'S AMAZING BECAUSE I
THINK WHAT COULD GET LOST IN THE
PRIOR ITERATION WAS THAT IT WAS
A CROSSCUTTING PRIORITY.
BUT TO HAVE A DISTINCTIVE GOAL
FOR CAPACITY BUILDING AND
TRAINING BIOMEDICAL RESEARCH
WORKFORCE, I THINK DISTINGUISHES
IT AND MAKES IT SO MEANINGFUL IN
TERMS OF WHAT THE NIH IS TRYING
TO DO TO BUILD THE WORKFORCE.
AS YOU KNOW IN INFECTIOUS
DISEASE, WE HAD REDUCTIONS IN ID
MATCHES, AT LEAST TWO YEARS AGO,
AND THIS IS JUST CRITICAL TO
BUILDUP THE CAPACITY AND
TRAINING WORKFORCE.
SO I LOVE THAT SO MUCH.
AND I JUST WANTED TO GIVE THAT
FEEDBACK THAT I THOUGHT THAT WAS
FANTASTIC.
>> THANK YOU FOR SHARING THAT.
AND I'LL ADD TO THE COMMENT THAT
THIS IS REALLY AN NIH-WIDE
INTEREST IN HAVING A SPECIFIC
FOCUS AND A SEPARATELY CALLING
OUT CAPACITY.
AND SO, THIS WAS PART OF THE NIH
COMMON TEMPLATE FOR STRATEGIC
PLANS WHERE THE EXPECTATION IS
NOW THAT ALL STRATEGIC PLANS
ACROSS NIH WILL KIND OF
SEPARATELY ADDRESS THE RESEARCH
QUESTIONS VERSUS THE CAPACITY
INFRASTRUCTURE AND TRAINING
NEEDS.
SO THANKS FOR YOUR COMMENT.
>> ANY OTHER COMMENTS OR
QUESTIONS?
>> IF I MAY, JUST TO REITERATE
THAT WE WILL BE CALLING YOU TO
JOIN THESE TASK FORCES VERY SO
SOON.
SO, WE WILL BE IN TOUCH VIA
E-MAIL.
WE'LL BE GETTING YOUR
AVAILABILITY BUT WE ARE THINKING
SORT OF LATE SPRING, EARLY
SUMMER FOR SOME INTENSIVE WORK
AND SERIAL MEETINGS, MAYBE 3-4,
AND THESE WILL NOT BE PUBLIC
MEETINGS.
THESE ARE CLOSED TASK FORCE
MEETINGS.
BUT THE ACTIVITIES OF EACH OF
THE GROUPS WILL BE COLLATED AND
REPORTED OUT AT THE JUNEAU RACK
AND AT THE OCTOBER OARAC LATER
THIS YEAR.
SO STAY TUNED AND THANK YOU VERY
MUCH FOR THE FEEDBACK.
>> THANK YOU.
ALL RIGHT, I DON'T SEE ANYMORE
RAISED HANDS.
SO I'D LIKE TO TAKE THE
OPPORTUNITY TO THANK YOU, TO ALL
OF OUR PRESENTERS AND OARAC
MEMBERS FOR SUCH A FRUITFUL
DISCUSSION.
WE WILL NOW TAKE A 15-MINUTE
BREAK.
WE'LL RETURN PROMPTLY AT 2:00.
PLEASE DO NOT LOG OUT OF YOUR
ZOOM MEETING, BUT DO MUTE YOUR
LINE AND PLEASE HIDE YOUR
CAMERA.
SEE YOU ALL BACK IN 15.
>> WELCOME BACK FROM THE BREAK,
EVERYONE.
WE WILL NOW HEAR A BRIEFLY
UPDATE FROM OTHER NIH ADVISORY
COUNCILS AND THE NATIONAL AIDS
EXECUTIVE COMMITTEE.
I WOULD LIKE TO INVITE
DR. MONICA GANDHI,
DR. MARGUERITA LIGHTFOOT.
>> DR. MELANIE OTT AND
Ms. CORETTE BYRD, TO PROVIDE
SUMMARIES OF RECENT MEETINGS OF
THE AIDS RESEARCH ADVISORY
COUNCIL, NATIONAL ADVISORY
MENTAL HEALTH COUNCIL, NATIONAL
ADVISORY COUNCIL ON DRUG ABUSE
AND THE NIH HIV/AIDS EXECUTIVE
COMMITTEE.
DR. MONICA GANDHI IS ALSO
WELL-KNOWN TO THE OARAC AS A
PRIOR CHAIR.
SHE SERVED AS PROFESSOR OF
MEDICINE AND ASSOCIATE DIVISION
CHIEF WITH THE DIVISION OF HIV,
INFECTIOUS DISEASE AND GLOBAL
MEDICINE AT UCSF SAN FRANCISCO
GENERAL HOSPITAL.
DR. MARGUERITA LIGHTFOOT SERVES
AS SORT DEAN FOR RESEARCH AND A
PROFESSOR AND HEALTH EQUITY AT
THE OREGON HEALTH AND SCIENCE
UNIVERSITY AND PORTLAND STATE
UNIVERSITY SCHOOL OF PUBLIC
HEALTH.
DR. MELANIE OTT SERVES AS
DIRECTOR AND SENIOR INVESTIGATOR
AT THE GLAD STONE INSTITUTE OF
VIROLOGY AND MIMINOLOGIY AND
PROFESSOR OF MEDICINE AT THE
UNIVERSITY OF CALIFORNIA SAN
FRANCISCO.
AND Ms. CORETTE BYRD SERVES AS
A HEALTH SCIENCE POLICY ANALYST
MEETING OAR, HIV INFO AND
CLINICAL GUIDELINES ACTIVITIES
AND OTHER COURSE CUTTING OAR AND
NIH ACTIVITIES.
DR. GANDHI, WE WILL BEGIN WITH
YOU.
>> THANK YOU VERY MUCH.
SO THIS IS REALLY A REPORT ABOUT
NIAID ADVISORY COUNCIL AND ARAC.
NEXT SLIDE, PLEASE.
SO ONE THING THAT STARTED OUT
EVERY MEETING AT THE MOMENT IS
THIS DISTRESSING SLIDE OF THE
POTENTIAL HOUSE CUTS TO NIAID
THAT SEEMS TO TARGET NIAID
SPECIFICALLY.
THIS HAS BEEN A SLIDE THAT IS
REALLY BEEN CIRCULATING FOR A
WHILE NOW.
BUT LUCKILY, WITH CONTINUING
RESOLUTIONS, AND HOPEFULLY
ADVOCACY IN CONGRESS, THIS WILL
NOT COME TO PASS.
BUT THIS IS HOW THINGS START OUT
AT THE NIAID ADVISORY COUNCIL
MEETINGS FOR THE LAST SEVERAL
MEETINGS.
SO, ON THE PLUS SIDE, AFTER
SEEING THAT SLIDE WE ALL HATE,
THIS IS THIS INCREASED FUNDING
TO NIAID THAT HAS BEEN QUITE
AGGRESSIVE OVER THE YEARS,
INCLUDING IN THE CONTINUING
RESOLUTION OF THE REALLY FLAT
FUNDING FROM 2023-2024 AND THEN
THIS SLIDE AT THE BOTTOM RIGHT
THAT SHOWS US HOW THE FUNDING AT
NIAID IS DIVIDED INTO HIV VERSUS
NON-HIV PRIORITIES, REALLY BIG
EMPHASIS ON ANTIMICROBIAL
RESISTANCE WHICH IS INCREDIBLY
IMPORTANT AND THEN EMERGING
INFECTIOUS DISEASES GET PULLED
INTO ALL OF THAT, ACTUALLY.
NEXT SLIDE.
SO, THEN THE REMAINDER OF THE
DAY WAS A REPORT BACK FROM FOUR
PROGRAMS AND THAT WAS SUCH A
GOOD DAY TO HEAR REALLY
COMPREHENSIVE WAY WHAT'S BEEN
HAPPENING BIOMEDICAL,
BIOBEHAVIORAL, SOCIAL
BEHAVIORAL, SCIENCE AND BASIC
TRANSLATIONAL RESEARCH ACROSS
NIAID.
IT'S SO INCREDIBLY EXCITING.
SO THESE WERE THE FOUR REPORT
BACKS.
AND THE FOUR LEADERS OF THOSE
PROGRAMS THAT PRESENTED THOSE
FOUR REPORT BACKS.
NEXT SLIDE.
SO TO GIVE THE HIGHLIGHTS FROM
THE THERAPEUTICS RESEARCH
PROGRAM PRESENTED BY DR. KIM,
THERAPEUTICS RESEARCH PROGRAM IS
TO INCLUDE THE HEALTH OF PEOPLE
LIVING WITH HIV BUT THAT
INCLUDES TB TREATMENT, HEPATITIS
TREATMENT AND PANDEMIC RESPONSES
IS IN THAT, BECAUSE OF THE COVID
AND M POX RESPONSE GOT FOLDED
INTO A LOT OF THE HIV CLINICAL
TRIAL NETWORKS.
AND SO, REALLY A DIVISION
DR. KIM TALKED TO US ABOUT FOUR
LONG-TERM GOALS, NEW AND
IMPROVED TREATMENTS AND
STRATEGIES WHICH FOLDS NICELY
INTO THE NEW PRIORITIES THAT WE
JUST WENT OVER, NIH HIV
PRIORITIES, POINT OF CARE AND
HOME BASED BIOG NOSTICS AND WE
HAVE DONE A LOT OF STRATEGIES ON
CURE AND ADDRESSING KEY
MORBIDITIES THROUGH STRATEGIES
FOR COOPERATION IN THESE REALLY
KEY MOMENTS WITH TB AND
HEPATITIS.
AND THEN HIGHLIGHTED SOME VERY
MAJOR ADVANCES THAT CAME
ABSOLUTELY DIRECTLY OUT OF THE
THERAPEUTICS RESEARCH PROGRAM
OVER THE LAST YEAR.
WHAT I THINK HAS BEEN EXTREMELY
EXCITING IS NOT ONLY THE
RESEARCH ON LONG ACTING
FORMULATIONS AND YESTERDAY THERE
WAS A PRESS RELEASE FROM NIAID
ON THE STUDY SHOWING THAT LONG
ACTING ART IS SUPERIOR TO ORAL
ART IN PARTICIPANTS WITH
ADHERENCE CHALLENGES, THAT WAS
VERY EXCITING TO SEE THAT
YESTERDAY.
BUT THEN IN TERMS OF THE
CO-MORBIDITIES ASPECT, THIS
MAJOR PUBLICATION FROM ACTG
WHICH WAS THE REPRIEVE STUDY
PUBLISHED IN AUGUST HAS CHANGED
CLINICAL CARE ALREADY, THE USE
OF STATENS IN THOSE WHO ARE LOW
TO MODERATE RISK OF
CARDIOVASCULAR DISEASE IN PEOPLE
LIVING WITH HIV.
AND REALLY SHOWED THAT IN A
RANDOMIZED WAY A STATEN IS GOING
TO PREVENT CARDIOVASCULAR
DISEASE OUTCOMES.
THIS IS SO PIVOTAL TO HOW WE ARE
CHANGING OUR CARE YESTERDAY AND
WE JUST AUTOMATED THIS SO WE
REALLY HAVE TO MAKE AN EXCUSE
WHY YOU'RE NOT PUTTING YOUR
PATIENT ON A STAT IN.
SO THEN THEN IT WAS PREVENTION
SCIENCE PRIORITIES AND AN
AMAZING PORTFOLIO OF NEW
PREVENTION PRODUCTS.
A LOT ON ENGAGING KEY
POPULATIONS AND SOCIAL BASIC
SCIENCE, HOW IMPORTANT ADHERENCE
IS TO ANYTHING THAT INVOLVES
PREVENTION.
SO THIS WAS THE ROUND PORTFOLIO
AND THEN HIGHLIGHTED, NEXT
SLIDE, WAS REALLY NEXT SLIDE.
WAS REALLY SHOWING FOUR MAJOR
ACCOMPLISHMENTS THAT I THINK ARE
IMPORTANT TO JUST BRIEFLY
MENTION.
ONE IS A FOCUS FROM NIAID ON
DEVELOPMENT OF PEDIATRIC
FORMULATIONS AS WE ARE LOOKING
AT LONG ACTING FORMULATIONS, WE
DO NEED TO INCLUDE CHILDREN IN
THAT, ESPECIALLY WITH THE LOWER
RATES OF BOTH ACCESS AND
VIROLOGICAL SUPPRESSION IN
CHILDREN.
SO THINKING ABOUT PREVENTION
PRODUCTS FOR CHILDREN THAT ARE
PATCHES, SHOTS, SOMETHING THAT
CAN BE REALLY EASILY TAKEN.
THE SECOND WAS PREVENTION AND
TREATMENT FOR PREGNANT WOMEN AND
HIGHLIGHTING THE VAGINAL RING IN
PREGNANT WOMEN TO PREVENT HIV
DURING THAT TIME PERIOD.
THE THIRD IS THE DEVELOPMENT OF
NEW HIV PREVENTION TRIALS, OF
COURSE NIAID WAS PIVOTAL IN THAT
STUDY SHOWING SUPERIORITY -- AND
THEN FINALLY, REALLY A FOCUS ON
CHILDREN WITH BOTH PREVENTION
BUT ALSO TREATMENT WHICH I THINK
IS TERRIBLY IMPORTANT GIVEN THE
DISPARATE OUTCOMES ESPECIALLY IN
VERY YOUNG CHILDREN.
NEXT SLIDE.
THE THIRD FOCUS WAS ON THE BASIC
SCIENCES PROGRAM.
ALSO REALLY EXCITING.
I DO HAVE TO SAY IT WAS DIVIDED
INTO TWO THINGS.
ONE IS BASIC PIVOTAL WORK ON
CURE RESEARCH.
THE SECOND WAS BROADLY
NEUTRALIZING ANTIBODIES AND THE
PROMISE OF THOSE.
THERE WILL BE A LOT ON BONDING
NEUTRALIZING ANTIBODIES FOR
PREVENTION, TREATMENT AND CURE.
AND THEN FOCUS THROUGH THE BASIC
SCIENCES PROGRAM ON SCIENCE
WORKFORCE DIVERSITY.
NEXT SLIDE.
SO SOMETHING TO HIGHLIGHT THAT
REALLY PRIMARY AREAS OF FOCUS IN
THIS AREA WERE REALLY
MECHANISTIC WORK AROUND CURE,
SMALL MOLECULES, BIOLOGICS
ALREADY THERAPEUTICS, THIRD IS
IDENTIFYING THROUGH SURVEILLANCE
APPROACHES, THE CLINICAL OUTCOME
TO STUDY, BASIC SCIENCE
APPROACHES.
AND THEN FOURTH REALLY FOCUS ON
IMPLEMENTATION RESEARCH TO
COLLABORATE BETWEEN DIFFERENT
FEDERAL AGENCIES TO END THE HIV
EPIDEMIC.
SO REALLY BROAD SCOPE OF THE
BASIC SCIENCE PROGRAM.
AND THEN THE NEXT SLIDE SHOWS
THE LAST PRIMARY FOCUS, WHICH
WAS VACCINE PROGRAM.
WE HAD MAJOR SETBACKS EVEN
RECENTLY IN THAT MAJOR VACCINE
FILES BUT I THINK WE ARE STILL
REALLY HOPEFUL THAT THERE ARE
TRANSLATIONAL APPROACHES,
INCLUDING mRNA VACCINES THAT
COULD BE USEFUL FOR HIV.
AND SO THERE IS NOT ONLY FOCUS
ON NEW VACCINE STRATEGIES BUT ON
BROADLY NEUTRALIZING ANTIBODIES
FOR VACCINE AND THEN FINALLY,
VACCINE ADJUVANTS AND HOW TO
DESIGN THE ADJUVANTS AND REALLY
EXCITING TO SEE THE mRNA
VACCINE GET THE NOBEL PRIZE.
AND THEN THE LAST SLIDE
HIGHLIGHTED THAT THE OARAC
TALKED ABOUT THIS COMMUNITY PATH
ON SELF TESTING.
SO THANK YOU VERY MUCH.
>> THANK YOU, DR. GANDHI.
DR. MARGUERITA LIGHTFOOT OPEN TO
YOU.
>> THANK YOU.
SO NEXT SLIDE, PLEASE.
I'M HOPING TO GIVE YOU ALL
HIGH-LEVEL INFORMATION ON THINGS
THAT ARE HAPPENING ON NIMH AND
SOME SPECIFIC THAT WOULD BE OF
INTEREST TO THOSE CONDUCTING HIV
RESEARCH.
IN TERMS OF THE OVERARCHING NEW
NEWS HAPPENING IN NIMH, THERE IS
A NEW DIVISION REPLACING THE
FORMER OFFICE OF TECHNOLOGY
DEVELOPMENT AND COORDINATION.
SO THAT IS THE DIVISION OF DATA
SCIENCE AND TECHNOLOGY.
THIS NEW DIVISION IS GOING TO
PROVIDE VALUABLE SUPPORT TO NIMH
INVESTIGATORS, INCLUDING
LARGE-SCALE SEQUENCING, BRAIN
AND TISSUE BANK, DATA ARCHIVES,
NON-HUMAN PRIMATE RESOURCES AND
INSTRUMENTATION.
ALSO THIS DIVISION WILL SUPPORT
THE DEVELOPMENT OF NEW TOOLS,
TECHNOLOGIES AND APPROACHES FOR
BRAIN AND BEHAVIORAL RESEARCH
AND PROVIDE INFRASTRUCTURE
RELATED TO DATA MANAGEMENT.
SO THE DIRECTOR OF DST IS GREG
FARBER.
NIMH AS I MENTIONED LAST TIME,
IT'S CONTINUING ITS 75TH
ANNIVERSARY.
NEW THINGS TO NOTE IS THAT WE
LAUNCHED A NEW PODCAST SERIES
FOR THE ANNIVERSARY.
IT'S CALLED MENTAL HEALTH
MATTERS AND IT'S HOSTED BY
DR. GORDON, THE DIRECTOR.
THEY ALSO LAUNCHED A SOCIAL
MEDIA CAMPAIGN CALLED, I AM NIMH
AND IT SHOWCASING MEMBERS OF THE
DIVERSITY GROUP OF INDIVIDUALS
THAT WORK AT NIMH AND JUST
SHOWING THE PASSION AND THE
DIVERSITY OF WORK THAT IS
HAPPENING AROUND NIMH AND THE
WORK IT'S DOING.
NIMH ALSO IS HEAVILY PARTNERED
AND INVESTED IN SUICIDE
PREVENTION.
SO THEY RECENTLY PARTNERED WITH
SAMHSA AND RECENTLY AWARDING
ABOUT 230 MILLION DOLLARS IN
GRANTS FOR SUICIDE PREVENTION
AND BEHAVIORAL HEALTH FOR
MARGINALIZED COMMUNITIES.
AND SO NIMH HAS A COUPLE OF
NOTICES OUT RIGHT NOW FUNDING
MECHANISMS, THAT ARE SUPPORTING
THIS WORK ON SUICIDE PREVENTION.
NIMH IS ALSO VERY MUCH INVESTED
IN BRAIN RESEARCH.
SO RESEARCHERS FROM THE BRAIN
INITIATIVE -- SOMETHING I WANTED
TO HIGHLIGHT IS WE HEARD ABOUT
THESE SUCCESSES FROM THIS
FUNDING.
ONE OF THE THINGS WE HEARD ABOUT
WERE THE RESEARCHERS FROM THE
BRAIN INITIATIVE CELL CENSUS
NETWORK, THERE ARE TWO MAJOR
ACCOMPLISHMENTS.
SO THEY DETAILED CELL MAPS TO
THE HUMAN BRAIN AND THE
NON-HUMAN PRIMATE BRAIN RECENTLY
IN A SERIES OF PUBLICATIONS.
AND SO IT REALLY SHOWCASED
EXCEPTIONALLY COMPLEXED
DIVERSITY OF CELLS HAPPENING IN
THE BRAIN AND HOPEFULLY IT WILL
LEAD TO A NEW GENERATION OF
TREATMENTS.
IN TERMS OF SOME ALSO HIGH-LEVEL
CHANGES IN PERSONNEL, ANN
HOUSTON WHO WAS THE NIMH DEPUTY
DIRECTOR OF MANAGEMENT AND THE
EXECUTIVE OFFICER.
SHE RECENTLY RETIRED.
THIS PARTICULAR POSITION
PROVIDED STRATEGIC DIRECTION AND
MANAGEMENT OF THE ADMINISTRATIVE
FUNCTIONS WHICH INCLUDED
OVERSILENT OF THE BUDGET AND
OVER 1600 STAFF, CONTRACTORS AND
STUDENTS.
A REPLACEMENT HAS NOT BEEN FOUND
YET FOR THAT POSITION BUT SHE
HAD BEEN THERE FOR OVER 30
YEARS.
RELEVANT TO THIS GROUP, TO OARAC
AND HIV RESEARCHERS, NIMH
ANNOUNCED THE APPOINTMENT OF
GREG GREENWOOD AS THE DEPUTY
DIRECTOR OF THE NIMH DIVISION OF
AIDS RESEARCH.
AND SO AS DEPUTY DIRECTOR, HE IS
GOING TO OVERSEE THE
DEVELOPMENT, DIRECTION AND
COORDINATION AND EVALUATION OF
DAR PROGRAMS.
THE DIVISION OF AIDS RESEARCH
PROGRAMS AND ACTIVITIES.
HE WILL ALSO CONTINUE TO SERVE
AS THE BRANCH CHIEF OF THE
DEVELOPMENTAL AND CLINICAL
NEUROSCIENCE OF HIV PREVENTION
AND TREATMENT BRANCH.
SO, GREG IS SUCCEEDS TIM
BROWERS, WHO I HAD MENTIONED AT
THE LAST MEETING, RETIRED IN
FEDERAL SERVICE IN 2023.
IN TERMS OF FUNDING, SIMILAR TO
NIAID, WE ALSO GO OVER THE
FUNDING FOR NIMH AT EVERY
COUNCIL MEETING AND FUNDING
LEVELS.
SO AS YOU CAN SEE HERE, NIMH
AWARDED 579 NEW GRANTS AND
COMPETING RESEARCH PROJECTS IN
FISCAL YEAR 23.
SO THAT REFLECTS AN OVERALL
SUCCESS RATE OF ABOUT 22%.
NIMH AWARDS MORE THAN 85% OF THE
RO1 APPLICATIONS SCORING IN THE
20th PERCENTILE OR BETTER.
HERE IS A GRAPH LOOKING AT
FUNDING OVER TIME.
SO FROM FISCAL YEAR 10 TO FISCAL
YEAR 23, NIMH RECEIVED INFLATION
ADJUSTED BUDGET OF ABOUT 18%.
THAT IS GOOD NEWS.
BUT ON THE MORE SIMILAR TO WHAT
DR. GANDHI TALKED ABOUT WHEN WE
LOOK AT THE CONTINUING
RESOLUTION, NIMH IS CURRENTLY
OPERATING UNDER THAT CONTINUING
RESOLUTION THROUGH MARCH OF
2024.
SO, WHILE UNDER THAT CONTINUING
RESOLUTION, NON-COMPETING GRANTS
WILL BE AWARDED AT LEVELS BELOW
THE COMMITTED AMOUNTS, TYPICALLY
AT ABOUT 90%.
AND AS YOU ALL KNOW, ON JANUARY
7, THERE WAS A AGREEMENT ON THE
FISCAL YEAR TOP LINE FUNDING
LEVELS WHICH WAS 772 BILLION FOR
NON DEFENSE PROGRAMS.
SO, THIS AGREEMENT REFLECTS A
FLAT BUDGET FOR MANY NON-DEFENSE
PROGRAMS, INCLUDING NIMH.
NEXT SLIDE.
THERE ARE A NUMBER OF FUNDING
OPPORTUNITIES THAT I THOUGHT
WOULD BE OF INTEREST TO THIS
AUDIENCE.
THE FIRST ONE IS LOOKING AT
INTERVENTIONS TO REDUCE SUICIDE
AMONG YOUNG PEOPLE AND
UNDERSERVED POPULATIONS.
THIS INITIATIVE WILL SUPPORT
REACH TO TEST THE EFFECTIVENESS
OF COMBINED STRATEGIES TO BOTH
THE TECH AND INTERVENE TO REDUCE
THE RISK OF SUICIDE, SUICIDE
IDEATION AND BEHAVIOR.
AND/OR NON-SUICIDAL SELF HARM,
AMONG CHILDREN AND ADOLESCENCE
FROM UNDERSERVED POPULATIONS.
THE SECOND HERE IS A
STREAMLINING MENTAL HEALTH
INTERVENTIONS FOR YOUTH LIVING
WITH HIV AND LMICs.
THE PURPOSE OF THIS INITIATIVE
IS TO USE NOVEL METHODS TO
STREAMLINE EVIDENCE-BASED MENTAL
HEALTH INTERVENTIONS FOR YOUTH
LIVING WITH HIV.
SO THEY REQUIRE FEWER RESOURCES
WHILE STILL LEADING TO
CLINICALLY MEANING IMPROVEMENTS
IN MENTAL HEALTH AND HIV
OUTCOMES.
AND THEN THE LAST ONE HERE SEEKS
TO ADVANCE DATA SCIENCE RESEARCH
IN HIV.
AND IT'S INTENDED TO ENCOURAGE
THE GENERATION OF CUTTING-EDGE
SYNTHETIC DATASETS, ARTIFICIAL
INTELLIGENCE AND MACHINE
LEARNING APPROACHES TO EXPAND
CAPACITY TO ADDRESS THE DYNAMIC
COMPLEX AND EVOLVING HIV
EPIDEMIC.
SO TEAM SCIENCE APPROACHES WHERE
THE STRENGTH AND EXPERTISE OF
MULTIPLE INDIVIDUALS ACROSS DATA
AND COMPUTATIONAL SCIENCES,
BIOSTATS, BEHAVIORAL AND SOCIAL
SCIENCES, COMPUTER SCIENCE AND
HIV PREVENTION AND CARE IS WHAT
IS REALLY STRONGLY ENCOURAGED
FOR THIS.
AND I ALSO LISTED THE NUMBERS
HERE FOR THOSE CALLS.
NEXT SLIDE.
WE HEARD -- COUNCIL HEARD AND
APPROVED TWO CONCEPT CLEARANCES
THAT WERE RELATED TO HIV THIS
ROUND.
SO THE FIRST WAS PRESENTED BY
DR. LORI SHELTON, GENERATIVE
ARTIFICIAL INTELLIGENCE,
OPPORTUNITIES AND CHALLENGES FOR
HIV CLINICAL CARE.
SO THE GOAL OF THIS CONCEPT WAS
TO ENCOURAGE THE USE OF
MULTI-MODAL AI TO ACCELERATE
DIAGNOSIS, PREVENTION AND
TREATMENT.
SO THE CONCEPT IS CONSISTENT
WITH THE HHS-AI STRATEGY.
SO MORE SPECIFICALLY THIS
CONCEPT AIMS TO ENCOURAGE THE
USE OF MULTI-MODAL AI IN
CLINICAL CARE THAT CAN EXPAND
OUR CAPACITY TO ADDRESS THE
DYNAMIC COMPLEX AND EVOLVING HIV
EPIDEMIC AND IT HAS THREE MAIN
GOALS.
THE FIRST IS DEVELOPMENT,
ADAPTATION AND USE OF ACCURATE,
SAFE AND EFFICIENT AND UNBIASED
AI MODELS TO SUPPORT DIVERSE
RANGE OF HIV APPLICATIONS.
THE SECOND IS THE CREATION OF
KNOWLEDGE GRAPHS TO STRENGTHEN,
MODAL INTERPRETATION AND
EXPLAINABILITY OF APPLICATIONS
OF AI APPLICATIONS IN HIV
RESEARCH CLINICAL CARE AND
PUBLIC HEALTH.
AND THE THIRD IS EXPLORATION OF
SINNER GEANISTIC INTEGRATION OF
KNOWLEDGE GRAPHS AND MODELS FOR
MORE RECISE MODEL OUTPUTS AND
INCREASE USE OF HIV CLINICAL
CARE.
THE SECOND CONCEPT CLEARANCE WAS
PRESENTED BY DR. JOSEPH AT DAR.
THE GOAL OF THIS CONCEPT WAS TO
ENCOURAGE RESEARCH TO DEFINE THE
MECHANISMS AND ROLES OF T-CELLS
AND HIV AND CNS RESERVOIR
SEEDING AND PERSISTENCE IN
NEUROPATHOGENESIS.
SO THIS RESEARCH WILL BE
CRITICAL IN DEVELOPING
THERAPEUTIC STRATEGIES FOR
TARGETING CNS RESERVOIRS AND
ONGOING NEUROINFLAMMATION THAT
DRIVES CNS CO-MORBIDITIES.
SO, THEY ARE LOOKING FOR --
LOOKING AT THIS BEING ABLE TO
DEFINE MECHANISMS OF
NEUROINVASION OF HIV INFECTED
T-CELLS AND ACUTE AND CHRONIC
BASES OF INFECTION, TO ADDRESS
THE ROLE OF T-CELLS AND CNS
SEEDING AND PERSISTENCE.
TO DEFINE T-CELL CONTRIBUTION TO
CNS HIV CLEARANCE,
NEUROINFLAMMATION AND
NEUROPATHOGENESIS AND TO DEVELOP
THERAPEUTIC STRATEGIES TO TARGET
T-CELL NEUROINVASION RESERVOIR
MAINTENANCE AND
NEUROPATHOGENESIS.
NEXT SLIDE, PLEASE.
WE ALSO HEARD HIV-RELATED
RESEARCH HIGHLIGHT.
SO THIS WAS HIGHLIGHTING SOME
RESEARCH THAT IS CURRENTLY BEING
FUNDED BY NIMH.
SO THIS AS WE KNOW, CURRENT
ANTI-RETROVIRAL THERAPY DOESN'T
COMPLETELY ELIMINATE HIV FROM
THE NERVOUS SYSTEM.
AND HIV CAN LIE DORMANT WITHIN
BRAIN RESERVOIRS FOR MANY YEARS
WHERE IT CAN INTEGRATE INTO THE
GENOME OF THE HOST CELLS AND
CONTRIBUTE TO HIV-ASSOCIATED
NEUROLOGICAL DISORDERS.
SO THIS GROUP AT GEORGE MASON
UNIVERSITY IS SEEKING TO TEST A
HIGHLY INNOVATIVE MODULAR
APPROACH TO PRODUCING LONG TERM
STABLE SILENCING OF HIV
TRANSCRIPTION BY DELIVERING
ANTIVIRAL MODALITIES THROUGH
EXTRACELLULAR VESICLES TO
HIV-INFECTED CELLS.
SO THESE BRAIN DERIVED
EXTRACELLULAR VESICLES ARE NOVEL
AND THEY CAN CARRY LARGE TARGET
HIV-INFECTED CELLS AND THE
INVESTIGATOR WILL TEST THIS
METHOD TO PRESS EXPRESSION LONG
TERM IN THE BRAIN AND ULTIMATELY
INHIBITING HIV NEUROLOGICAL
DISORDERS.
SO THIS APPROACH CAN OFFER NEW
PLATFORMS FOR DELIVERY
THERAPEUTICALLY RELEVANT RNAs
TO TARGET CELLS AND MAY
ELIMINATE HIV IN INDIVIDUALS.
I BELIEVE THAT IS MY LAST SLIDE.
THANK YOU VERY MUCH.
>> THANK YOU DR. LIGHT FOOT.
DR. OTT, OVER TO YOU.
>> THANK YOU VERY MUCH HELLO,
EVERYBODY.
I'M GOING TO GIVE YOU THREE
HIGHLIGHTS FROM THE CURRENT NIDA
PORTFOLIO HIGHLIGHTING SOME OF
THE UNIQUE ASPECTS OF THE
RESEARCH DONE AT NIDA.
NEXT SLIDE, PLEASE.
THE FIRST ONE IS A NIDA FUNDED
STUDY THAT HAS LOOKED AT
OVERDOSE DEATH AMONG PEOPLE WITH
HIV IN NEW YORK CITY.
AND THEY HAVE COMPARED THAT RATE
SPECIFICALLY AMONG PEOPLE WITH
HIV COMPARED TO THE OVERALL
DEATH RATE BASED ON OVERDOSES
AND FOUND THAT THE RATE IS
ACTUALLY DOUBLE IN PEOPLE WITH
HIV.
AND THEN THEY DUG DEEPER AND
LOOKED AT WHETHER PEOPLE WITH
HIV DIVIDED ON THE LEFT SIDE AND
ACCIDENTAL OVERDOSE DEATH OR ON
THE RIGHT SIDE INTENTIONAL
OVERDOSE DEATH, WERE ACTUALLY IN
CLINICAL CARE AND FOUND THAT
MOST OF THEM HAD BEEN RETAINED
IN A RELATIVELY HIGH LEVEL OF
CLINICAL CARE, INDICATING THERE
WERE PLENTY OF OPPORTUNITIES TO
POTENTIALLY PREVENT THESE
OVERDOSES.
AND HIGHLIGHTING REALLY AN
IMPORTANT WINDOW OF OPPORTUNITY
HERE THAT OBVIOUSLY WAS MISSED.
THE SECOND IS A VERY PRACTICAL
ONE.
IT IS A MOBILE VAN THAT WAS
ESTABLISHED BY A RECENT ADJUVANT
GUARD AT YALE UNIVERSITIY.
SHE IS AN M.D., PH.D. AND HAS
ESTABLISHED THIS COMBINED RETAIL
PHARMACY AND CLINIC VAN ON
WHEELS THAT IS SPECIFICALLY
TARGETED TO PEOPLE WITH HIV, HEP
C AND SUBSTANCE USE DISORDERS.
AND HER REASONING IS THAT PEOPLE
IN THAT CATEGORY OFTEN HAVE A
LOT ON THEIR PLATE INCLUDING
UNSAFE HOUSING AND OTHER THINGS
SO THAT HEALTH CARE COMES REALLY
LAST ON THE LIST OF THEIR NEEDS.
AND BRINGING IT DIRECTLY TO THEM
IS THE APPROACH HERE TO REALLY
IMPROVE CARE FOR PEOPLE
AFFLICTED WITH THESE DISORDERS.
AND I THINK THERE IS A LOT OF
ENTHUSIASM ABOUT THE APPROACH
AND A LOT OF FIRST SUCCESSES AND
WE ARE LOOKING REALLY FORWARD TO
SEEING HOW THIS IS PANNING OUT
AS A POTENTIAL MODEL.
NEXT SLIDE.
AND THE THIRD ONE IS SHINING
LIGHT ON CLIMATE CHANGE AND HOW
THIS EFFECTS MORTALITY OF HIV
INFECTED PEOPLE.
THE POINT IS HERE THAT THERE WAS
A LARGE COHORT STUDY IN AFRICA
WHO LOOKED AT THE INDIVIDUAL
RESEARCH RESULTS FROM THESE
CENTERS, SPECIFICALLY MORTALITY,
IN THESE CENTERS, COMPARED TO
RELATIVE RAINFALL DECREASE.
AND FOUND THAT ACTUALLY, A
DECREASE OR SHORTAGE OF RAINFALL
TRANSLATED, ESPECIALLY IN RURAL
AREAS, TO A SIGNIFICANT INCREASE
IN MORTALITY.
IT DID NOT CHANGE CD4 COUNTS OR
VIRAL LOADS OR EVEN LARGER THAN
12 MONTH GAPS IN CARE.
BUT IT LED TO LESS SIGNIFICANTLY
LESS VISITS INTO THE CENTERS,
POTENTIALLY TRANSLATING INTO
TREATMENT AND CARE UPDATES OR
LACK OF THOSE.
AND DISTURBING INCREASE IN
MORTALITY DIRECTLY LINKED OR
LINKED TO A DECREASE IN RAINFALL
AND RESULTING FROM CLIMATE
CHANGE.
NEXT SLIDE.
THERE ARE A COUPLE -- A SERIES
OF VERY INTERESTING HIV FUNDING
OPPORTUNITIES PUBLISHED BY NIDA.
AND THEY RANGE FROM A VERY
INTERESTING -- ADDRESSING REALLY
SOCIOECONOMIC CHARACTERISTICS IN
THE NIDA PORTFOLIO RANGING FROM
SEXUAL AND GENDER MINORITIES TO
PSYCHOSOCIAL STRESS, PSYCHIATRIC
DISORDERS, SEXUAL VIOLENCE AND
TRAFFICKING, TO MORE BASIC
RESEARCH TOPICS, ALSO TARGETING
HIV CURE BY MODULATING HIV
TRANSCRIPTION WITH SPECIFICALLY
CHEMICAL PROBES TO STUDYING THE
AUTOPHAGY AND INTERPLAY WITH
CELL DEATH AND HIV PATHOGENESIS.
AND SPECIFICALLY THE EFFECT OF
HIV AND SUBSTANCE USE
CO-MORBIDITIES ON THE MATERNAL
OUTCOME.
FOR THE FUTURE, NEXT SLIDE,
COUNCIL APPROVED THE FOLLOWING
CONCEPTS WHERE RESEARCH TO
ADDRESS MULTI-LEVEL BARRIERS AND
FACILITATORS TO IMPROVE PrEP
IS SPECIFICALLY HIGHLIGHTED
TOGETHER WITH ADVANCING RESEARCH
ON MOLECULAR TARGETS, MECHANISMS
THAT INFLUENCE INTERPLAY BETWEEN
SEX HORMONES, ADDICTED
SUBSTANCES AND HIV INFECTION.
MITOCHONDRIAL-ASSOCIATED
MECHANISMS OF NEUROPATHOLOGICAL
AND IMMUNODEFICIENT AGING IN THE
CONTEXT OF HIV AND SUBSTANCE USE
DISORDER.
WASTE NOT, WANT NOT.
EXPLORING INTERACTIONS BETWEEN
BRAIN WASTE CLEARANCE AND
RENEWAL SYSTEMS WITH HIV AND
ADDICTION.
AND MECHANISM OF CELL-TO-CELL
INTERACTIONS AND COMMUNICATION
IN CENTRAL NERVOUS SYSTEM HIV
REPLICATION.
SO I THINK ALSO LEARNING SOME OF
THE SORT OF COMMON THEMES WITH
THE OTHER INSTITUTES WHERE I
THINK REPLICATION IN THE BRAIN
COMBINED WITH AGING AND
SPECIFICALLY SEX-SPECIFIC
ASPECTS ARE REALLY PRIORITIZED
HERE.
WITH THIS, I WILL STOP AND HAND
OVER TO THE NEXT SPEAKER.
>> THANK YOU DR. OTT.
NOW WE'RE GOING TO GO TO
Ms. CORETTE BYRD.
>> THANK YOU VERY MUCH,
DR. TURNBULL.
GOOD AFTERNOON AND GOOD MORNING.
I THINK IT'S SAFE TO SAY FOR
THOSE ON THE WEST COAST AS WELL
AS HAPPY NEW YEAR.
IT IS NICE TO SEE MANY OF YOU
AGAIN, AND TODAY I WILL PROVIDE
A BRIEF OVERVIEW OF A FEW
ADDITIONAL HIV CONCEPTS AND
RE-ISSUED CONCEPTS SINCE THE
OCTOBER OARAC MEETING BY THE
INSTITUTE CENTERS AND OFFICES
HERE AT NIH.
SO HERE SAY SUMMARY OF ALL NEW
AND RE-ISSUED CLEARED CONCEPTS.
AND AS YOU CAN SEE, THERE ARE 12
NEW AND FOUR RE-ISSUED CONCEPTS
FOR A TOTAL OF 16.
THE NATIONAL INSTITUTE ON
ALLERGY AND INFECTIOUS DISEASE
HAS THREE NEW CONCEPTS.
AND THE NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS HAS ONE
NEW CLEAR CONCEPT.
NIAID, THEIR FIRST CONCEPT
RESOURCE RELATED RESEARCH TO
SUPPORT COLLABORATIVE
IMPLEMENTATION SCIENCE TO END
HIV EPIDEMIC IS A NOTICE OF
SPECIAL INTEREST TO SOLICIT
PROPOSALS FOR RESOURCE-RELATED
RESEARCH PROJECTS, INCLUDING A
COORDINATION, CONSULTATION AND
DATA MANAGEMENT CENTER.
AND REGIONAL CONSULTATION HUBS
TO SUPPORT ONGOING
IMPLEMENTATION SCIENCE RESEARCH
THAT ADDRESSES THE GOALS OF
ENDING THE HIV EPIDEMIC IN THE
U.S.
THE NEW DRUG CLASSES WITH NOVEL
MECHANISMS OF ACTION FOR HIV,
HEPATITIS B AND TUBERCULOSIS,
SUPPORTS SMALL BUSINESSES IN THE
DEVELOPMENT OF NEW DRUG CLASSES
FOR HIV, HPV OR TUBERCULOSIS
THERAPY, WITH A DIFFERENT MODE
OF ACTION THAN FDA-APPROVED
DRUGS CURRENTLY IN USE.
AND THE THIRD DEVICES AND
MATERIALS-BASED PLATFORMS FOR
THE DELIVERY OF BROADLY
NEUTRALIZING ANTIBODIES SUPPORTS
SMALL BUSINESSES IN A
DEVELOPMENT OF DEVICES AND/OR
MATERIALS FOR ADMINISTRATION OF
THE DERIVATIVES RESULTING IN
INCREASED PROTECTION FROM
INFECTION.
FOR NINDS, THE NEXT GENERATION
PRE-CLINICAL MODELS OF NEUROHIV
IN THE CART ERA, SOLICITS
APPLICATIONS FOR THE DEVELOPMENT
AND EARLY STAGE VALIDATION OF
NEXT GENERATION HUMAN AND SMALL
ANIMAL MODELS AND/OR HUMAN
CELLULAR MICROPHYSIOLOGICAL
SYSTEMS THAT IMPROVE THE
TRANSLATIONAL RELEVANCE OF
NEUROHIV MODELS.
SPECIFICALLY IN THE CONTEXT OF
CHRONIC HIV INFECTION OF THE
CENTRAL NERVOUS SYSTEM AND THE
MODERN ANTI-RETROVIRAL THERAPY
ERA UNDER CONDITIONS OF VIRAL
SUPPRESSION.
THESE ARE THE FIVE NEWLY CLEARED
CONCEPTS FROM NIDA.
AND ON THIS SLIDE, THE NATIONAL
INSTITUTE OF DENTAL AND
CRANIOFACIAL RESEARCH HAS ONE
NEW CLEAR CONCEPT AND THE
NATIONAL INSTITUTE OF MENTAL
HEALTH HAS TWO NEWLY-CLEARED
CONCEPTS WHICH HAVE BEEN
DISCUSSED BY DR. LIGHT FOOT.
FOR NIDCR, ADVANCING HIV/AIDS
AND ORAL HEALTH RESEARCH SEEKS
TO SOLICIT INNOVATIVE AND
MULTI-DISCIPLINARY BASIC,
TRANSLATIONAL AND CLINICAL
RESEARCH ON HIV/AIDS THAT IS
RELEVANT TO DENTAL, ORAL AND
CRANIOFACIAL HEALTH.
IN TERMS OF CONCEPTS FOR
RE-ISSUANCE, THE NATIONAL
INSTITUTE OF ALLEY JEER AND
INFECTIOUS DISEASE RE-ISSUED TWO
CONCEPTS AND THE NATIONAL
INSTITUTE OF CHILD HEALTH AND
DEVELOPMENT AND THE NATIONAL
INSTITUTE OF DRUG ABUSE EACH
HAVE RE-ISSUED ONE CONCEPT.
NIAID'S RAPID DIAGNOSTIC ASSAYS
FOR SELF-MONITORING OF ACUTE OR
REBOUND HIV-1 INFECTION AIMS TO
DEVELOP LOW-COST RAPID
DIAGNOSTIC ASSAYS TO ENABLE
UNTRAINED INDIVIDUALS TO TEST
FOR HIV-1 INFECTION.
DURING THE EARLIEST STAGES OF
INITIAL FINNECTION OR DURING
LOSS OF VIRAL SUPPRESSION IN
CHRONIC TREATED INFECTION, A
TIME WHEN ANTIBODY RESPONSES ARE
NOT AN ACCURATE SURROGATE FOR
VIRAL LOAD.
FOR NICHD'S PEDIATRIC HIV/AIDS
COHORT STUDY, SUPPORTS RESEARCH
ON A DEVELOPMENTAL AND CLINICAL
COURSE OF PERIFATALITY ACQUIRED
HIV.
THE TRANSITION TO ADULTHOOD WITH
PERRY NATALY ACQUIRED HIV,
PROVIDES AN IMPORTANT
OPPORTUNITY TO UNDERSTAND A HOST
OF SIGNIFICANT HEALTH OUTCOMES
INCLUDING REPRODUCTION, ORAL,
COGNITIVE, NEURODEVELOPMENTAL,
MENTAL HEALTH, SUBSTANCE USE,
BEHAVIORAL, EMOTIONAL, ACADEMIC
AND SOCIAL OUTCOMES.
FOR NIAIDA'S SEEKS TO STIMULATE
OBSERVATIONAL OR INTERVENTIONAL
RESEARCH ON STRUCTURAL FACTORS,
ORGANIZATIONAL PRACTICES,
POLICIES AND OTHER SOCIAL,
CULTURAL AND CONTEXTURAL
INFLUENCES THAT LEAD TO
INEQUITIES AT THE INTERSECTION
OF HIV AND SUBSTANCE USE AMONG
UNDERSERVED, RACIAL AND/OR
ETHNIC MINORITY POPULATIONS
AFFECTED BY PERSISTENT HIV
DISPARITIES.
AND LASTLY, SCORCH, THE SINGLE
CELL OPIOID RESPONSES IN THE
CONTEXT OF HIV PROGRAM SUPPORTS
DATA-MINING ON SINGLE CELL
DATASETS TO IDENTIFY CELL TYPES,
TRANSCRIPTS, ENHANCERS OR
TRANSCRIPTIONAL NETWORKS THAT
PLAY A ROLE IN HIV, ART OR
SUBSTANCE USE DISORDER RELEVANT
MOLEC LARRY RESPONSES.
AND TO SUPPORT FUNCTIONAL
VALIDATION STUDIES SUCH AS
EPIGENOMIC.
TO CONFIRM OR DENY A BIOLOGICAL
ROLE FOR ONE OR MORE OF THE DATA
CELL TRANSCRIPTS ENHANCERS OR
TRANSCRIPTIONAL NETWORKS IN HIV
AND ART AND SUBSTANCE USE
DISORDERS, MOLEC LARRY RESPONSE.
>> WE ARE NOW OPEN FOR
DISCUSSION.
ONCE AGAIN, FEEL FREE TO USE THE
RAISE HAND OPTION IN THE CHAT.
DR. HOLTZ IF YOU CAN SEE
ANYBODY'S HAND RAISED, THAT I
CAN'T SEE, LET ME KNOW.
>> I SEE JONATHAN MERMIN.
>> THANK YOU.
WHAT A FANTASTIC SET OF
PRESENTATIONS.
IT'S GREAT TO WELCOME ALL THE
NEW PEOPLE TO OARAC.
I THINK I HAVE ONE SMALL AND
THEN A BIGGER KIND OF BIGGER
QUESTION.
I THINK THE IDEA OF HAVING SOME
KIND OF NUCLEIC ACID TEST FOR
SELF TESTING FOR HIV IS
TREMENDOUS.
AND I WANTED TO MENTION THAT NOT
ONLY ALL THOSE OTHER REASONS YOU
MENTIONED, BUT WE HAVE A LOT OF
TROUBLE FROM PEOPLE ON PrEP.
AND OUR CURRENT RECOMMENDATIONS
ARE QUITE CONSTRAINING ON WHAT
KIND OF TESTS ARE AVAILABLE.
AND IF YOU COULD DO HOME TESTING
FOR NUKE LAKE ACID ON PrEP,
THEN YOU COULD ESSENTIALLY NOT
HAVE TO VISIT A CLINIC.
JUST GET YOUR MEDS.
SO EVEN A BIGGER OPPORTUNITY FOR
THAT.
SO IT'S GREAT THAT YOU'RE
THINKING ABOUT THOSE THINGS.
THEN THE OTHER QUESTION I HAD
WAS JUST THAT THERE IS SO MUCH
GOOD WORK ON THE NEW STRATEGIC
PLAN, IT SEEMS TO BE REFRAMING
THE AREAS FOR FOCUS.
BUT ONE OF THE QUESTIONS THAT
COMES UP IS, IT'S TRULY ABOUT
SHIFTING RESOURCES TO DIFFERENT
AMOUNTS FOR EACH OF THOSE FOCIS.
SO, HOW MUCH OF THE MONEY THAT
COMES TO OAR AND THEN FOR HIV
RESEARCH IN GENERAL SHOULD BE
GOING TO COINJECTIONS VERSUS A
CURE, VERSUS OTHER FOCI?
AND I'M JUST THINKING BECAUSE
ALL OF THE RESEARCH STUDIES ARE
IMPORTANT AND INTERESTING.
SOME MAY HAVE -- MAY BE MORE
POWERFULLY ALONG THE LOGIC MODEL
TOWARDS THOSE GOALS OF A CURE OR
A LONG-ACTING TREATMENT.
BUT I WONDER HOW THAT HAPPENS?
IS THAT SOMETHING THAT OAR DOES?
IS IT SOMETHING YOU WORK WITH
THE INSTITUTES TO DO?
>> THAT'S A REALLY GREAT
QUESTION.
AND I DON'T HAVE AN ANSWER FOR
YOU AT THIS MOMENT BUT IT IS
CERTAINLY SOMETHING THAT I CAN
LOOK INTO AND TO GET BACK TO YOU
ON THAT.
SO, THANK YOU VERY MUCH FOR THAT
QUESTION.
>> EXCELLENT PRESENTATIONS.
MY QUESTION, I JUST WOULD LIKE
TO ASK DR. LIGHT FOOT, THAT WAS
REALLY INNOVATIVE, MOLECULAR
APPROACH TO PRODUCE THIS -- TO
CHOOSE THIS EXTRACELLULAR
VESICLES.
SO THE VESICLES, THAT WOULD
SPECIFICALLY TARGET THE MAIN
RESERVOIR WHICH ARE MICROGLIA'S
IN THE BRAIN?
I WOULD JUST LIKE TO KNOW IF
THAT WOULD BE THE APPROACH?
>> IS DR. LIGHT FOOT STILL ON?
MAYBE ON MUTE?
>> NO WORRIES.
I CAN FIGURE OUT THE
APPLICATIONS.
>> I DON'T SEE THAT SHE IS STILL
ON LINE.
APOLOGIES ABOUT THAT.
>> THANK YOU.
PERHAPS WE CAN FIGURE OUT HOW
DR. LIGHTFOOT HAS AN OPPORTUNITY
TO RESPOND TO DR. MOJGAN
NAGHAVI'S QUESTION.
DR. LUIS MONTANER.
>> IN THE CAPACITY OF THE
ADVISORY ROLE OF THIS GROUP, I
WANT TO SPEAK ABOUT CURE AND AS
ONE OF THE AREAS THAT NEEDS TO
GROW IN THE PORTFOLIO AS FAR AS
INVESTMENT AND RELATIVE TO THE
PRIORITIES.
AND I WOULD LIKE TO SUGGEST THAT
WE ARE MAYBE ENCOURAGING MAYBE
IN AID PARTICULARLY TO CONSIDER
A SMALL PHASE I OR PROOF OF
PRINCIPLE STUDIES.
I SIT IN THE CURE TSG AS WELL AS
THE LABORATORY, AND THE
COLABORATORIES ARE REALLY
GENERATING A LARGE NUMBER OF
INITIATIVES THAT ARE REALLY IN
THE NEED OF PROOF-OF-CONCEPT
CLINICALLY BUT A LOT OF THE
TRIALS THAT ARE BEING PROPOSED
ARE KIND OF LIKE LARGER
INITIATIVES THAT LOOK FOR SORT
OF AN IMPACT ON THE RESERVOIR
AND IMPACT ON THE REBOUND WITH
SORT OF EXPECTATIONS THAT THE
APPROACHES WOULD WORK IN-VIVO,
WHEREAS IF WE HAD A SYSTEM THAT
HAD LIKE A SMALLER PHASE I TYPE
OF PROOF OF PRINCIPLE, SHORT
INVESTMENT AND SHORT DURATION,
THEN MAYBE WE COULD POTENTIALLY
CREATE A PIPELINE FOR MORE HUMAN
STUDIES THAT COULD LEVERAGE SOME
OF THESE PROOF OF PRINCIPLE
INITIATIVES.
AND RIGHT NOW, THERE IS THE CURE
INITIATIVE THAT THE ACDG IS
OFFERING BUT THESE AS WELL
PROPOSED SORT OF VERY SORT OF
COMPREHENSIVE TRIALS HAVE BEEN
WAITING TO DEVELOP.
SO I'M NOT SUGGESTING THEY ARE
NOT WARRANTED.
THEY ARE.
BUT I THINK THAT THERE IS ROOM
FOR A LOT OF MORE GROWTH IN
SMALLER INITIATIVES THAT
POTENTIALLY COULD TAKE ADVANTAGE
OF ALL OF THESE STRATEGIES THAT
ARE EMERGING THROUGH THE
COLLABORATORIES.
>> THANK YOU.
DR. COLLINS.
>> THANK YOU FOR TAKING MY
QUESTION.
I GUESS ON A RELATED THEME OF
MOVING THINGS TO THE CLINIC,
EVEN BEFORE PHASE I TRIALS IT
CAN BE CHALLENGING FOR
INVESTORS -- INVESTIGATORS TO
MOVE FROM SMALL-MOLECULE
CANDIDATES TO THE NEXT STAGE
BECAUSE EFFICACY IS HARD TO
REALLY ESTABLISH IN SMALL-MODELS
THAT CURRENTLY EXIST FOR HIV
DISEASE, ESPECIALLY FOR NEED
IMMUNE RESPONSE AND YOU NEED
ANTI-RETROVIRAL THERAPY AND
EVERYTHING AND FOR THE ANIMAL TO
LIVE LONG ENOUGH FOR A THOROUGH
TEST.
ANIMAL MODELS ARE SUPER TRICKY.
AND SO I THINK SOME HELP WITH
INVESTIGATORS IN MOVING
CANDIDATE SMALL MOLECULES FOR
COMPLEX IMMUNOLOGIC FUNCTIONS
FROM THE BENCH INTO MAYBE LARGER
MODELS, EVEN BEFORE PHASE I IS
AN AREA THAT I THINK MANY PEOPLE
COULD GET SOME HELP WITH TO KIND
OF MOVE FORWARD THE CURIOUS
STRATEGIES THAT ARE EXPERIMENTAL
AT THIS POINT.
>> THANK YOU DR. COLLINS.
ANY OTHER HANDS?
DR. HOLTZ DO YOU SEE ANY HANDS
ON YOUR SIDE?
>> I WANTED TO QUICKLY JUST
RESPOND TO A QUESTION.
I WAS HAVING TOGGLING ISSUES ON
MY MUTE BUTTON.
THE ANSWER IS ESSENTIALLY BOTH.
WE FOLLOW THE BUDGET AND WE HAVE
A LEGISLATIVE TEAM THAT FOLLOWS
THE BUDGET AND WHAT IS HAPPENING
WITH THE BUDGET ON THE HILL VERY
CLOSELY WITH OUR TEAM AND WE
WORK WITH THAT INFORMATION ABOUT
WHAT THE POSSIBLE BUDGET CUTS
WILL BE.
OF COURSE IT ISN'T IN THE
APPROPRIATIONS USUALLY, SPECIFIC
PRIORITY AREAS, BUT WE TRY TO
MAKE SURE THAT IT'S BALANCED AND
IF THERE IS AN INCREASE OR
DECREASE, THAT WE HAVE RESEARCH
PRIORITIES IN MIND.
THE OAR DIRECTOR OR ACTING
DIRECTOR HAS DIRECT LINK TO ALL
THE IC DIRECTORS WITHIN OUR
AGENCY AND IS IN CONTACT WITH
THEM REGARDING ANY CHANGES IN
THE BUDGET AND WE ALSO DISCUSS
THIS AT THE NIH AIDS EXECUTIVE
COMMITTEE.
>> THANK YOU.
THANK YOU FOR SUCH A LIVELY
DISCUSSION.
OUR FINAL UPDATE FOR TODAY WILL
COME FROM THE HIV CLINICAL
GUIDELINES WORKING GROUP OF
OARAC.
THESE INCLUDE BOTH GUIDELINES
AND PANEL UPDATES.
WE HAVE FOUR PRESENTERS TODAY.
DR. AMAZE MAS, DR. A POW POW,
DR. NAHIDA CHAKTOURA,
DR. FRANKLIN YATES.
>> DR. CHRISTINE MIASKOWSKI IS
THE FOUNDING THE TORAND LEAD OF
GUIDELINES FOR MANAGEMENT OF
OPPORTUNISTIC INFECTION IN
ADOLESCENCE WITH HIV.
-- DR. HENRY PASUR.
DR. PAU IS A CRITICAL MEMBER OF
THE ADULT AND ADOLESCENCE
ANTI-RETROVIRAL GUIDELINES PANEL
SINCE 1998 AND BECAME THE
EXECUTIVE SECRETARY OF THE PANEL
IN 2003.
SHE IS A CO-ED TORE OF THE PANEL
ON TREATMENT AND PREVENTION OF
OPPORTUNISTIC INFECTION AND THE
LEAD UP OF THE FORMS OF THESE
GUIDELINES.
DR. NAHIDA CHAKTOURA IS THE
CHIEF MEDICAL OFFICER IN THE
PEDIATRIC INFECTION DISEASE
BRANCH AT THE EUNICE KENNEDY
DRIVER NATIONAL INSTITUTE OF
OF CHILD HEALTH AND HUMAN
DEVELOPMENT.
SHE OVERSEES VARIOUS HIV/AIDS
RELATED CLINICAL TRIALS AND
ADOLESCENCE EVENTS WITHIN THE
INTERNATIONAL PEDIATRIC
ADOLESCENT CLINICAL TRIAL
NETWORK.
DR. FRANKLIN YATES IS A MEDICAL
OFFICER IN THE MATERNAL AND
PEDIATRIC INFECTIOUS DISEASE
BRANCH AT THE EUNICE KENNEDY
DRIVER NATIONAL INSTITUTE
OF CHILD HEALTH AND DEVELOPMENT.
HIS RESEARCH INCLUDES HIV
PREVENTION STRATEGY AMONG YOUTH
AND ADOLESCENTS AND EVALUATING
TOOLS FOR CARE NAVIGATION AND
MANAGEMENT OF HIV AND VIRAL
HEPATITIS AND THEIR
CO-MORBIDITIES IN LOW-RESOURCED
SETTINGS.
DR. MASUR, WE WILL START WITH
YOU.
>> THANK YOU FOR THAT
INTRODUCTION.
TO START WITH THE -- TWO
QUESTIONS I WANT TO ADDRESS.
ONE IS, ARE THESE GUIDELINES
STILL NEEDED AND USED?
NUMBER 2, WHAT ARE WE DOING WITH
THE GUIDELINES?
SO WE CAN SEE THE NEXT SLIDE.
IF YOU LOOK AT THE NUMBER OF --
OVER THE LAST FEW YEARS, WE HAVE
HAD ABOUT 500,000.
THIS SUGGESTS THAT EVEN THOUGH
IT WAS UP-TO-DATE WITH ON LINE
RESOURCES, PEOPLE STILL RELY ON
THIS BECAUSE THEY SEE IT -- I
THINK AS AN AUTHORITATIVE AND
NEEDED ACCESSORY SOURCE.
IF YOU LOOK AT THE TOTAL NUMBER
FROM LAST YEAR, IT'S ABOUT THE
SAME.
IT'S INTERESTING TO LOOK AT WHAT
PEOPLE REALLY WANT TO KNOW
ABOUT.
AND IF YOU LOOK AT THE LEFT SIDE
OF THIS, THE RED IS 2022, THE
BLUE IS 2023.
REALLY THE 5 OR 6OIs IMPORTANT
IN LATE 1980S ARE STILL THE SA
SAME.
BUT IF YOU LOOK AT THE
RIGHT-HAND SIDE, WHILE VERY FEW
PEOPLE RELATIVELY LOOK AT THESE,
WE SEE THOSE AS ALMOST EQUALLY
VALUABLE BECAUSE FOR MOST OF US,
WE SEE A PATIENT WITH HIV, WE
REALLY DO NEED EXPERT ADVICE IF
YOU WANT TO KNOW WHO ACCESSES
THESE, MUCH THESE COME FROM THE
UNITED STATES.
THE OTHER COUNTRIES THAT YOU SEE
HERE LISTED ARE PROBABLY NOT
SURPRISING, AND THIS IS USED IN
ASIA, USED IN EUROPE AND THIS IS
USED IN LATIN AMERICA.
NOT SURPRISING THAT THESE HAVE A
WIDE VIEWERSHIP.
BUT WE SEE THAT OUR MANDATE IS
REALLY TO ADDRESS THE UNITED
STATES.
SO WE MAINTAIN WE HAVE THE
AGENCIES OR THE ABILITY TO
HANDLE OPPORTUNIES.
WE HANDLE OPPORTUNISTIC
INFECTIONS AS THEY WOULD BE
DEALT WITH IN OTHER HEALTH CARE
SYSTEMS.
IF YOU WANT SOME IDEA OF THE
RANGE OF THINGS WE UPDATE, WE
MAKE A EFFORT TO TRY TO KEEP
THESE GUIDELINES CURRENT AND WE
TURN OUT AS MANY UPDATES PER
YEAR AS WE THINK ARE
APPROPRIATE.
AND JUST TAKING A QUICK LOOK,
YOU CAN SEE HERE THAT THERE ARE
QUITE A FEW SECTIONS THAT
RECENTLY WE HAVE MADE UP.
WHAT DO THESE UPDATES LOOK LIKE?
IF YOU LOOK AT SYPHILIS AS AN
EXAMPLE, WE INCLUDE SOME
CLINICAL INFORMATION ABOUT
WHAT'S NOT SO NEW BUT MORE
OCULAR SYPHILIS BEING SEEN.
ALTHOUGH WE ARE NOT
COMPREHENSIVE, WE DO UPDATE
INFORMATION ABOUT DIAGNOSTICS,
PARTICULARLY THE TWO DIFFERENT
DIAGNOSTIC APPROACHES.
WE DON'T GIVE A SPECIFIC
RECOMMENDATION FOR DOXYBUT WE
MENTION IT BECAUSE IT IS A
RECOMMENDATION AND THE
SYPHILIS -- AND WE ADDRESS WHAT
THE OPTIONS ARE IN TERMS OF
PENICILLIN SHORTAGES, AND THAT
PROBABLY NEEDS TO BE UPDATED
AGAIN.
SOME OF THE UPDATES ARE MORE
MINOR BUT STILL IMPORTANT.
HEPATITIS B, FOR INSTANCE, HEP I
WILL SAF, THE ADJUVANT VACCINE
FOR HEPATITIS B HAS BEEN MOVED
UP AND NOW CONSIDERED THE FIRST
LINE VACCINE.
UPDATES ARE CURRENT FOR INSTANCE
MEN I THINK COCKAL VACCINE AND
THESE ARE HARMONIZED WITH CDC
AND EVERYTHING GETS REVIEWED AND
APPROVED BY CDC BEFORE IT GOES
OUT.
AND THEN FOR MONKEY POX, THAT
HAS HAD ITS UPS AND DOWNS
EPIDEMIOLOGICALLY AND WE TRY TO
KEEP THE CURRENT CLINICAL
EXPERIENCE AT LEAST SUMMARIZED
WITH REFERENCES AND AS THERE ARE
CHANGES IN PREVENTION OR
THERAPY, THOSE WILL BE CHANGED
AS WELL.
THERE IS SOME CONTROVERSIAL
ISSUES.
THERE ARE PEOPLE ON THIS PANEL
WHO KNOW A LOT MORE ABOUT HPV
THAN I DO.
ONE OF THE THINGS WE STRUGGLED
WITH IS THE INTERNATIONAL ANAL
NEOPLASIA STUDY ISSUED NEW
GUIDELINES THIS PAST YEAR AND
THEY WERE BASED ON NEW ENGLAND
JOURNAL OF MEDICINE SAYING THAT
THE GAPLESS KEY, ALSO ON OUR
PANEL WHO IS THE LEADER AUTHOR
ON, AND THAT REALLY IS THE FIRST
DATA THAT OBJECTIVELY SHOWS THE
SCREENING EARLY INTERVENTION ARE
IMPORTANT IN TERMS OF REDUCING
ANAL CANCER, AT LEAST IN ONE
POPULATION.
WE HAVE SEVERAL PROBLEMS.
ONE IS WE HAVE TO MAKE SURE WE
AGREE ON WHAT THE CONTENT IS AND
WHAT IS EVIDENCE-BASED AND WHAT
IS BASED ON EXPERT OPINION.
AND OF COURSE IN MOST
RECOMMENDATIONS AND THE
GUIDELINES, DON'T HAVE DATA.
THEY HAVE EXPERT PERSON, WHICH
WE THINK IS USEFUL BUT IT'S JUST
A DIFFERENT LEVEL OF WHAT IS
BEING RECOMMENDED.
A SECOND PROBLEM IS IN TERMS OF
MAKING THE INFORMATION
UNDERSTANDABLE.
WE HAVE BEEN THROUGH A COUPLE OF
ITERATIONS OF THIS SECTION
OURSELVES.
WE LOOKED AT WHAT THE
INTERNATIONAL ANAL NEOPLASIA
SOCIETY HAS, AND IT IS VERY HARD
TO UNDERSTAND THE TABLES AND THE
TEXT IF YOU'RE A CLINICIAN
TRYING TO FIGURE OUT WHAT TO DO.
AND WE ARE WORKING ON TRYING TO
MAKE THAT UNDERSTANDABLE WITH
MORE FLOW DIAGRAMS AND BETTER
TABLES, BUT GIVEN THE DATA, THAT
ISN'T EASY.
WE ALSO WANT TO HARMONIZE
EVERYTHING WITH ACOG AND THE
NEOPLASIA SOCIETY CLINICIANS IF
POSSIBLE, AND NOT CONFRONT WITH
DIFFERENT TABLES AND DIFFERENT
RECOMMENDATIONS.
AGAIN THERE MAY BE SOME SLIDE
DIFFERENCES BUT WE UNDERSTAND
THAT THERE ARE A LOT OF PEOPLE
WHO THINK WE NEED TO GET THESE
GUIDELINES OUT.
WE WANT TO MAKE SURE WE CAN
STAND BY THE CONTENT AND THAT
THE PRESENTATION IS
UNDERSTANDABLE.
BY THE TIME UPDATES GET REVIEWED
BY ALL AFTER THE DEVELOPMENT, IT
DOES TAKE TIME FOR THESE
VOLUNTEER GROUPS TO REVIEW
THESE.
WE TRY TO SPEED THIS UP AS MUCH
AS POSSIBLE, AND TO MAKE SURE
THAT THESE KEEP MOVING ALONG.
WE ARE ALSO VERY AWARE OF THE
FACT THAT WE NEED TO MAKE SURE
THAT OUR MEMBERSHIP IS
REPRESENTATIVE AND THAT THERE IS
WIDE ACCESS TO BEING ON THE
PANEL.
WE HAVE OVER 100 MEMBERS IN OUR
VARIOUS GROUPS ON THE PANEL.
PEOPLE SERVE A FOUR-YEAR TERM.
WE DO ADVERTISE BUT REMEMBER WE
ALSO SOLICIT FOR MEMBERS WHO
RECOMMEND OTHERS AND THERE IS
SOME ROTATION IN THE SUBJECT
GROUP LEADS AND THE MEMBERS EACH
YEAR.
AND AGAIN, WE ARE COGNIZANT OF
WHAT THE PROFILE OF OUR
PANELISTS ARE.
SO, YOU CAN STOP THE SLIDES.
THAT'S REALLY A SUMMARY OF WHERE
WE ARE.
AND YOU CAN DECIDE WHAT YOU WANT
TO TAKE QUESTIONS AT THE END OF
EACH PRESENTATION OR WAIT UNTIL
THE END OF ALL OF THEM.
THANK YOU.
>> THANK YOU.
ARE WE ARE GOING TO WAIT AND
TAKE THE QUESTIONS AFTER
EVERYBODY MAKES THEIR
PRESENTATION.
DR. PAU OVER TO YOU.
>> THANK YOU.
THANK YOU EVERYONE FOR INVITING
ME TO GIVE YOU A PRESENTATION OF
WHAT HAPPENED SINCE THE LAST
TIME WE REPORTED.
IF I CAN HAVE THE NEXT SLIDE,
PLEASE.
SO, WE HAD AN UPDATE IN DECEMBER
OF 2023.
WE MAINLY FOCUSED ON TWO
DIFFERENT TOPICS AT THAT TIME.
ONE IS HIV 2 AND THE OTHER IS AN
UPDATE ON THE EARLY ACUTE OR
RECENT HIV INFECTION.
HIV-2, WE USUALLY UPDATE THAT
PROBABLY EVERY TWO OR THREE
YEARS OR SO AND AS THEY ARE NOT
AS MUCH NEW DATA AVAILABLE AND
ALSO IS NOT AS RELEVANT,
HOWEVER, WE DO RECOGNIZE THAT WE
HAVE INDIVIDUALS THAT ARE IN THE
U.S. COMING FROM COUNTRIES
ENDEMIC WITH HIV-2 AND NOTING
THAT A COUPLE OF IMPORTANT
ISSUES THAT WE WANT TO ADDRESS.
ONE OF WHICH IS THE FACT THAT WE
ALL KNOW THAT IT IS
INTRINSICALLY CONSISTENT TO
NNRTIs AND BECAUSE OF THAT,
NOW BECAUSE OF THIS REGIMEN
SWITCHING IN MOST COUNTRIES
AROUND THE WORLD, THAT IS NO
LONGER AS MUCH OF AN ISSUE,
HOWEVER, WE DO RECOGNIZE THAT
SOME PEOPLE MAY NOT BE THINKING
ABOUT THE USE OF LONG-ACTING --
IN THE CASE OF PATIENTS WHO
EITHER HIV-2 OR HAS CO-INFECTION
WITH HIV-1 AND 2.
SO WE MORE EXPLICITLY PUT OUT A
RECOMMENDATION THAT IN PATIENTS
WHO HAVE BEEN DIAGNOSED WITH
HIV-2, THE USE OF LONG ACTING --
IS NOT RECOMMENDED.
RECOGNIZING THAT VERY FEW
INDIVIDUALS WITH MULTIDRUG
RESISTANT HIV-2 INFECTION IN
VITRO DATA HAS SHOWN THAT BOTH
THESE DRUGS HAVE GAINS IN HIV-2
AND POTENTIALLY USED IN THE CASE
WHERE THERE ARE PATIENTS THAT
HAS MULTIPLE DRUG RESISTANT
INFECTION.
AND LASTLY, THERE ARE NOW MORE
CLINICAL DATA TO LOOK AT THE
EFFICACY OF DOLUTEGRAVIR IN THE
TREATMENT OF HIV-2 SO WE ARE
MORE CONFIDENT IT WILL BE AN
EFFECTIVE REGIMEN TO BE USED IN
THAT SETTING.
THE OTHER THING WE TRY TO UPDATE
IS WITH REGARDS TO EARLY HIV
INFECTION AND THAT IS PRIMARILY
BY UPDATING THE DATA THAT WERE
REPORTED FROM EXTENDED ANALYSIS
FROM HPTN0 A LITTLE 3 TO LOOK AT
CAB-LA FOR PrEP VERSUS
PLACEBO.
THERE ARE A NUMBER OF REPORTS OF
CASES OF HIV OCCURRING WHILE THE
PATIENT WAS SUPPOSED TO BE
RECEIVING KABLA INCLUDING THOSE
ON LINE INJECTIONS ON TIME
INJECTIONS.
THEY ALSO, BECAUSE OF THE FACT
THAT THEY MIGHT HAVE LOW-LEVEL
OF HIV, IT MAY CAUSE DELAY IN
DIAGNOSIS.
AND AS WELL AS THE FACT THAT
THERE ARE A NUMBER OF CASES THAT
ARE REPORTED EACH THOUGH THE
NUMBERS ARE SMALL, OF
INDIVIDUALS AFTER THEY HAD BEEN
DIAGNOSED WITH HIV HAVE FOUND TO
HAVE MAJOR INSTI-RELATED
RESISTANT MUTATIONS.
AND BASICALLY THESE DATA
REINFORCED THE FACT IT'S
IMPORTANT TO TAKE THE HISTORY OF
A PATIENT WITH NEWLY DIAGNOSED
HIV TO NOTE THAT IF SOMEONE HAS
BEEN ON PRIOR HISTORY OF CAB-LA
USE FOR PrEP, THE GENOTYPE
SHOULD BE DONE AND ONE MAY NOT
WANT TO USE A REGIMEN UNTIL WE
KNOW FOR SURE THAT A PATIENT
DOES NOT HAVE -- RESISTANT
MUTATIONS.
NEXT SLIDE, PLEASE.
NOW THIS IS THE EXCITING PART.
THERE WERE REPRIEVE STUDY
PUBLISHED IN JULY 2023, HAS
SHOWN THERE WAS BENEFIT AS
PRIMARY PREVENTION OF
CARDIOVASCULAR DISEASES,
ESPECIALLY IN THE PATIENTS WITH
LOW TO MODERATE TENURED ASCVD
RISKS.
WE HAVE A LOT OF DEBATES WHERE
THIS BELONGS TO MAINLY BECAUSE
WE ARE THE ANTI-RETROVIRAL
TREATMENT GUIDELINES.
WE ALSO RECOGNIZE THE LIMITATION
OF OUR PANEL MEMBERS THAT WE
EVEN THOUGH WE ARE GENERAL
INTERNISTS, THIS WAS INFECTIOUS
DISEASES SPECIALISTS, WE REALIZE
THAT WE ARE NOT SPECIALISTS IN
CARDIOLOGY.
SO WE DON'T FEEL TOTALLY
COMFORTABLE IN MAKING OUR
RECOMMENDATION WITHOUT
CONSULTING EXPERTS IN THE AREA.
SO IN NOVEMBER OF 2023, WE
DECIDED THAT WE DO NEED TO MAKE
SOME RECOMMENDATION, EACH THOUGH
WE ARE ANTI-RETROVIRAL THERAPY
GUIDELINES.
WE HAVE CONSULTED WITH THE TWO
MAJOR ORGANIZATION, AMERICAN
COLLEGE OF CARDIOLOGY AND
AMERICAN HEART ASSOCIATION.
WE ALSO WORK WITH DRIVING HIV
MA, ESPECIALLY THOSE WRITING THE
PRIMARY CARE GUIDELINES AND ALSO
IN THE PROCESS OF TRYING TO
FIGURE OUT WHAT TO DO WITH THE
DATA.
AND TO TRY TO CREATE THE RAPID
COMMUNICATION ON THE USE OF STAT
IN WITH HIV.
SO WE FINALLY DEVELOPED THE
DOCUMENT AND THE DATE THAT I PUT
ON HERE FEBRUARY 29, WHICH IS
NEXT THURSDAY, IS NOT GOING TO
BE THE DATE.
WE TRIED TO MOVE IT UP TO NEXT
TUESDAY FOR RELEASE THAT WILL
COME OUT.
AND THIS DOCUMENT HAS BEEN
WRITTEN AS WELL AS ENDORSED BY
ALL THREE OF THE ORGANIZATIONS
ON TOP OF OUR PANEL.
SO AS I MENTIONED, IT WILL BE
RELEASED ON FEBRUARY 27.
NEXT SLIDE, PLEASE.
THIS IS A PREVIEW OF OUR DRAFT
RECOMMENDATIONS.
THIS IS WE DIVIDE THEM BASED ON
INDIVIDUAL RISKS.
THERE ARE MORE INFORMATION ABOUT
THOSE INDIVIDUALS WITH LESS THAN
20 -- GREATER THAN 20% RISK.
AND WE ALSO NEED READERS TO USE
THE CALCULATOR IN DETERMINING
THE RISK OF THE INDIVIDUAL
PATIENT.
AND THEN DIVIDE BY AGE 40-75
VERSUS LESS THAN ANAL 40 YEARS
OF AGE.
40-75 IS THE AGE RANGE IN WHICH
THE STUDY WAS BEING DONE.
AS WELL AS THAT IS THE AGE RANGE
IN WHICH THE AHAACC LIPID
GUIDELINES RECOMMENDATIONS CAME
FROM.
SO, WHEN INDIVIDUALS WHO ARE
BETWEEN AGE 40-75, WITH A 5-LESS
THAN 20% RISK, THE PANEL
RECOMMENDS AT LEAST A MODERATE
INTENSITY STAT IN WITH AN A ONE
RECOMMENDATION.
SO THIS IS A STRONG
RECOMMENDATION.
RECOGNIZING THAT THE STUDY
REPRIEVE WAS USING STAT IN, ALSO
RECOGNIZED THE FACT THAT NOT ALL
INSTITUTES HAVE THIS STAT IN IN
THE FORMULARY.
WE PROVIDED THE INFORMATION ON
THE USE OF TWO OTHER STAT INS
INCLUDING -- THESE INDIVIDUAL
STATINS THAT HAS SOME OTHER DATA
RATHER THAN LARGE RANDOMIZED
CONTROL TRIAL TO SHOW THEY HAVE
BENEFITS IN REDUCING
INFLAMMATION AND POTENTIALLY
HAVE SIMILAR BENEFITS AS SEEN
WITH TAPA STAT IN.
FOR INDIVIDUALS WITH LESS THAN
5% RISK, WOO INDICATED WE FAVOR
INITIATING A MODERATE IN DENSITY
STAT IN WITH A WEAKER
RECOMMENDATION.
NOTING THAT THE ABSOLUTE RISK IN
THESE -- THE BENEFITS FROM THE
STAT IN IS MODEST IN THIS
POPULATION BASED ON THE NUMBER
NEEDED TO TREAT FOR FIVE YEARS
IN THE REPRIEVE DATA.
AND BECAUSE OF THAT, THE
POSITION FOR INITIATING SHOULD
TAKE INTO ACCOUNT THE PRESENCE
OR ABSENCE OF OTHER HIV-RELATED
FACTORS THAT CAN INCREASE CBD
RISK.
BECAUSE OF THE FACT THAT THE
STUDY DID NOT STUDY INDIVIDUALS
FOR LESS THAN 40 YEARS OF AGE,
WE INDICATED THAT THE DATA I
BELIEVE SUFFICIENTLY WAS TO MAKE
RECOMMENDATION OR AGAINST THE
USE OF STATINS PRIMARY
PREVENTION IN THESE PATIENTS.
THE OTHER IMPORTANT INFORMATION
IS LIFESTYLE MODIFICATIONS
RECOMMENDED FOR THESE
INDIVIDUALS ESPECIALLY FOR THOSE
WHO HAVE OTHER RISK FACTORS FOR
CARDIOVASCULAR DISEASE.
NEXT SLIDE.
SO AS I MENTIONED BEFORE, THIS
WILL NOT HAVE BEEN DONE AND WE
WOULD NOT FEEL AS COMFORTABLE IN
MAKING OUR RECOMMENDATIONS
WITHOUT THE HELP OF OUR
COLLEAGUES FROM ACC, AHA AND HIV
MA.
I WANT TO ACKNOWLEDGE A NUMBER
OF OUR CONSULTANTS
REPRESENTATIVES FROM THOSE
ORGANIZATIONS THAT PARTICIPATED
IN A LOT OF PHONE CALLS WITH US
AND A LOT OF RECONCILING THE
DIFFERENT REGIMENS, DIFFERENT
DOCUMENTS THAT WE HAVE.
NEXT SLIDE, PLEASE.
ON TOP OF THATTINGS, WE ARE
REALLY WORKING VERY CLOSELY WITH
OUR PANEL TO UPDATE OTHER
SECTIONS OF THE GUIDELINES
WITHIN ANTICIPATION THAT NEW
UPDATES WILL COME OUT IN LATE
SPRING TO EARLY SUMMER AND THAT
INCLUDES A BRAND NEW SECTION ON
HIV AND TRANSPLANT WITH FOCUS ON
HOW TO MANAGE THE PATIENT
PRE AND POST TRANSPLANT NOTING
INTERACTIONS AND OTHER FACTORS.
OTHER SECTIONS TO BE UPDATED
INCLUDE WHAT TO START OPTIMIZING
ERT, HIV IN OLDER PEOPLE, IN
WOMEN, IN HEPATITIS B
CO-INFECTION, SUBSTANCE USE,
ADHERENCE, DRUG-DRUG
INTERACTIONS AND RENAL DOSING.
THAT IS ALL I HAVE.
THANK YOU.
>> THANK YOU VERY MUCH DR. PAU.
DR. NAHIDA CHAKTOURA.
>> THANK YOU VERY MUCH.
ON BEHALF OF MY EXCELLENT PANEL
OF VOLUNTEER EXPERTS AND
CO-CHAIRS I'M PRESENTING THE
UPDATES FROM THE PERINATAL
GUIDELINES THAT WERE RECENTLY
PUBLISHED IN JANUARY OF THIS
YEAR, JANUARY 31.
NEXT SLIDE, PLEASE.
SO AS I MENTIONED, THE -- I KEEP
GETTING A THING SAYING YOU WANT
ME TO START MY VIDEO.
I'M GOING TO TRY TO -- SO WE
HAVE FOUR CHAIRED SECTIONS WITH
OUR PEDIATRIC PANEL
COLLABORATORS AND SO WE HAVE
PUBLISHED ONE OF THE FOUR
SECTIONS AND THEN THE OTHER
THREE WILL BE PUBLISHED LATER ON
IN THE SPRING OF THE SO THE
UPDATE TO THE PREGNANCY AND
POSTPARTUM HIV TESTING AND
IDENTIFICATION OF THE PERINATAL
AND POSTNATAL EXPOSURE WAS
UPDATED.
THE OTHER THREE SUBSES WILL BE
UPDATED IN THE SPRING.
NEXT SLIDE, PLEASE.
SO THERE ARE MINOR REVISIONS
MADE TO INCORPORATE OR CONTINUE
TO INCORPORATE GENDER INCLUSIVE
LANGUAGE WHERE APPROPRIATE AND
WHERE APPROPRIATE ALSO IN LINE
WITH ALICE'S GUIDELINES OF THE
ADULT AND ADDS LES ENT PANEL.
AND WE ALSO MADE CLARIFICATIONS
AROUND THE TIMING OF EXPOSURE IN
PREGNANCY SO CLEARLY DEFINED.
THIS WAS AN INTRODUCTION
SECONDS.
CLEARLY DEFINED WHAT WE
CONSIDERED PERINATAL, WHICH
WOULD INCLUDE DURING PREGNANCY
AND LABOR AND DELIVERY AND THEN
POSTNATAL HIV TRANSMISSION FOR
THOSE THAT WOULD BE ACQUIRED
THROUGH THE BREASTFEEDING
PERIOD, WHICH IS OUTSIDE OF THE
PERINATAL TIMEFRAME.
NEXT SLIDE, PLEASE.
WE'VE ALSO UPDATED
RECOMMENDATIONS FOR THE AIV DRUG
MANAGEMENT DURING PREGNANCY FOR
PEOPLE TRYING TO CONCEIVE AND
THOSE ARE FOUND IN TABLE 6 AND
7.
AND WE UPDATED -- INSUFFICIENT
DATA TO RECOMMEND INJECTABLE
LONG-ACTING TREATMENT IN
PREGNANCY AND FOR INDIVIDUALS
WHO ARE ON LONG-ACTING THERAPY
FOR PrEP DURING PREGNANCY, THE
PANEL MADE SURE TO POINT OUT
THAT, REALLY TO DISCUSS THE
DECISION OF WHAT TO DO AND HOW
TO MANAGE INDIVIDUALS WHO BECOME
PREGNANT AND WHEN CONSIDERING
CHANGE TO EITHER ORAL REGIMEN
FOR INDIVIDUALS WHO ARE TRYING
TO CONCEIVE SO IT IS MORE OF A
PATIENT-CENTERED APPROACH IN
THEIR RECOMMENDATIONS.
NEXT SLIDE, PLEASE.
WE HAVE ALTERED OR CHANGED THE
RECOMMENDATION AS FOR PREFERRED
REGIMEN FOR TREATMENT FOR
PREGNANT PEOPLE WHO HAVE NEVER
RECEIVED ARV TO START WITH A
THREE-DRUG REGIMEN WITH DOLL TAG
VER-BASED REGIMENS.
WE CHANGED THE REGIMEN FROM
PREFERRED TO ALTERNATIVE FOR
INITIATION OF TREATMENT FOR
INDIVIDUALS DURING PREGNANCY
EXCEPT IN SITUATIONS WHERE THERE
IS A USE OF LONG-ACTING
TREATMENTS DUE TO CONCERNS WITH
THE RESISTANCE MUTATIONS, AS
ALICE MENTIONED EARLIER.
AND BIC TEGRA VEER IS
ALTERNATIVE TREATMENT FOR USE IN
PREGNANCY, INCLUDING FOR THOSE
INDIVIDUALS WITH HIV-2
INFECTION.
AND THAT IS A CHANGE FROM
INSUFFICIENT TO RECOMMENDED.
NEXT SLIDE, PLEASE.
SO WE ALSO UPDATED THE BULLETED
RECOMMENDATIONS AND THE TEXT TO
DEFINE LACK OF VIRAL SUPPRESSION
AND VIROLOGICAL FAILURE FOR
PREGNANT INDIVIDUALS FOR THOSE
WHO ARE NOT PREGNANT AND
CLARIFIED GUIDANCE ABOUT THE
EVALUATION AND MANAGEMENT WHEN
VIRAL SUPPRESSION IS NOT
ACHIEVED DURING PREGNANCY.
SO THAT IT IS CLEAR
RECOMMENDATIONS OF WHAT TO DO.
WE ALSO ADDED RECOMMENDATIONS
FOR VIRAL CO-INFECTION TESTING
IN INFANTS WHO ARE EXPOSED TO
HIV TO INCLUDE CONGENITAL,
HEPATITIS C AND THE B AND
PROVIDED LINKS ABOUT TESTING AND
CARE IN THOSE INDIVIDUALS IN OUR
SECTION RELATED TO INITIAL
POST-NATAL MANAGEMENT OF THE
NEONATES AND EXPOSED TO HIV.
AND WE HAVE UPDATED THE SAFETY
OF TOXICITY FOR INDIVIDUALS
ANTI-RETROVIRAL TREATMENTS TO
INCORPORATE NEW DRUGS, EACH
THOUGH THERE ARE NOT NECESSARILY
RECOMMENDED BUT JUST MAKE SURE
THAT WE HAVE INCLUDED THEM INTO
THE UPDATES FOR THE GUIDELINES.
AND THEN FINALLY TO MAKE AN
ANNOUNCEMENT ON BEHALF OF THE
PEDIATRIC PANEL IS THAT WE ARE
SOLICITING PANEL MEMBERS AS WELL
FOR THE PEDIATRIC PANEL.
THE APPLICATIONS ARE DUE NEXT
WEEK AND THE DETAILS ON THE
APPLICATION IS ON CLINICAL INFO
AND THE NEWS WEBSITE.
SO PLEASE ENCOURAGE PEOPLE TO
APPLY.
AND I WANT TO ACKNOWLEDGE OR
TAKE THE OPPORTUNITY TO
ACKNOWLEDGE AND THANK A MEMBER
OF OUR PANEL THAT A LONGSTANDING
MEMBER OF OUR PANEL, WHO HAS
REALLY MADE SIGNIFICANT
CONTRIBUTIONS AND HAS BEEN VERY
INSTRUMENTAL IN BOTH THE
PEDIATRIC AND THE PERINATAL
PANEL AND THAT IS DR. STORM.
AND SHE WILL BE RETIRING THIS
YEAR.
WE WILL SORELY MISS HER AND WE
JUST WANTED TO SAY THANK YOU.
>> THANK YOUAISETHYOU.
>> THANK YOU.
DR.IATES OVER TO YOU.
>> I'M FRANKLIN YATES, A MEDICAL
OFFICER WITH NICHD AND THE
PLEASED TO PRESENT UPDATES WITH
THE PEDIATRIC GUIDELINES FOR
2023.
NEXT SLIDE.
JUST TO ACKNOWLEDGE THERE HAVE
BEEN A COUPLE OF TRANSITIONS
THAT OCCURRED IN THE PAST YEAR.
FIRST AND FOREMOST, DR. BILL
KAPOGIANNIS, MY FRIEND AND
FORMER COLLEAGUE, HAS STEPPED
OUT OF THE ROLE OF EXECUTIVE
SECRETARY AND HAS MOVED ON,
ALTHOUGH WE ARE GRATEFUL THAT HE
IS -- REMAINS A PANEL MEMBER.
AND THEN ALSO DR. NESHEIM ALSO
TRANSITIONED OUT OF HIS ROLE.
AND WE ARE VERY GRATEFUL AND
THANKFUL FOR ALL OF HIS MANY
CONTRIBUTIONS IN A LONGSTANDING
MEMBER.
THIS SLIDE SERVES TO ILLUSTRATE
THAT THE CONSISTENCY AND THE
ROBUSTNESS OF THE LEADERSHIP OF
THE WEB PAGES, EVEN THROUGHOUT
THE COVID EPIDEMIC YEARS, AND
STILL HAVE AROUND THE SAME AS IN
2019.
NEXT SLIDE, PLEASE.
AND THIS SLIDE IS ILLUSTRATING
THE TOP 10 PAGE VIEWS AND
PERHAPS NOT UNEXPECTEDLY THE
MOST VIEWED PAGE IS THE WHAT'S
NOW SECTION IN THE GUIDELINES.
FOLLOWED BY THE RECOMMENDED
IMMUNIZATION SCHEDULE.
AND THEN SECTIONS OF PATHOGENS,
PCP, TOXO PLASMA AND
CYTOMEGALOVIRUS.
THESE DATA HAVEN'T REALLY
CHANGED MUCH OVER THE PAST FEW
YEARS.
NEXT SLIDE.
2023 WE PUBLISHED SEVERAL NEW
SECTIONS AND ABOUT FOUR NEW
APPENDICES.
FIRST THE INTRODUCTION WAS
COMPLETELY REWRITTEN AND NOW
SUMMARIZES KEY CHANGES THAT
RESULT FROM THE RESCOPING
CONSULTATION THAT OCCURRED IN
2021.
AND SOME OF THOSE IMPORTANT
CHANGES INCLUDE UPDATES TO THE
FREQUENCY WITH CERTAIN SECTIONS
WILL BE REVISED.
THEY WILL NOW BE REVISED ON AN
EITHER FOUR-YEAR SCHEDULE,
DEPENDING ON THE SECTION, AND
ALSO THE INTRODUCTION HIGHLIGHTS
TRANSITION TO THE NEW EVIDENCE
RATINGS SCHEME TO BE ALIGNED
WITH OTHER GUIDELINES.
THEY ALSO, IN SEPTEMBER,
PUBLISHED A UPDATE TO THE
CYTOMEGALOVIRUS SECTION AND A
KEY FINDING FROM THIS SECTION IS
THAT THERE IS NOW A UNIVERSAL
RECOMMENDATION TO TEST INFANTS
EXPOSED TO HIV FOR CONGENITAL
CMV.
WE ALSO PUBLISHED IN SEPTEMBER A
REVISED TB SECTION, AND ADDED
RECOMMENDATIONS FOR
INHIBITOR-BASED REGIMENS IN
CONTEXT OF TB DISEASE.
THERE IS ALSO NOW AN ADDED
RECOMMENDATION THAT SOME
CHILDREN OVER THE AGE OF TWO,
LIVING WITH HIV, CAN RECEIVE THE
LTBI TREATMENT REGIMEN.
WE HAVE A NUMBER OF SECTION
UPDATES COMING IN WENT TOY 24.
PROMISES TO BE A -- 2024 --
PROMISES TO BE A BUSY YEAR AND
CURRENTLY SLATED FOR PUBLICATION
IN THE EARLY STRING, IF NOT LATE
WINTER, WE HAVE HEPATITIS B
VIRUS SECTION.
THE HEP C VIRUS SECTION AND
SARS-COV-2 SECTION.
AND THEN ON TRACK FOR
PUBLICATION IN THE FALL, IS THE
SECTION ON VACCINE-PREVENTIBLE
DISEASES AS WELL AS BACTERIAL
INFECTIONS AND HPV SECTION.
I BELIEVE THAT IS MY LAST SLIDE.
>> THANK YOU.
COLLEAGUES, WE ARE NOW OPEN FOR
DISCUSSION.
ANY HANDS I'M NOT SEEING,
DR. HOLTZ?
HERE WE GO.
>> I SEE DR. AKE AND DR. JOHN
SLEASMAN.
>> I SEE THEM TOO NOW, THANK
YOU.
>> DR. AKE.
>> THANK YOU VERY MUCH, JOHN WAS
FIRST.
>> OKAY.
[ MULTIPLE SPEAKERS ]
>> THANK YOU VERY MUCH.
AND I GUESS I WOULD REITERATE
WHAT SOME OF THE DATA HAS SHOWN,
WHICH IS JUST HOW CONTINUOUSLY
THESE GUIDELINES CONTINUE ARE
USEFUL.
AND I WILL SAY THAT IT MIGHT BE
FOR SOME VERY CLINICALLY ACTIVE
PEOPLE WHO RUN INTO RARE
CIRCUMSTANCES, BUT WE HAPPEN TO
BE PART OF A REALLY DIVERSE
COMMUNITY OF PEOPLE WHO ARE
RESEARCHERS WHO, THEY MAY ONLY
SPEND TWO MONTHS A YEAR SEEING
PATIENTS.
AND I WOULD SAY IT'S EQUALLY IF
NOT MORE SO USEFUL FOR SUCH AN
UP-TO-DATE EXPERT,
EVIDENCE-DRIVEN RESOURCE TO BE
AVAILABLE FOR THOSE CLINICIANS
AS WELL.
I THINK IN MANY WAYS, THOSE WHO
SPEND SO MUCH TIME DEVELOPING
THESE GUIDELINES INFLUENCE THE
CARE FOR SO MANY, THEY ARE
UNSUNG HEROES IN OUR FIELD AND I
JUST WANT TO CONVEY THAT
APPRECIATION AND EXTEND MY THANK
YOU TO ALL OF THOSE INDIVIDUALS
WHO ARE LEAVING THE PANELS WE
HEARD ABOUT.
THEY PROBABLY DON'T HAVE A SENSE
FOR HOW MANY INDIVIDUAL PATIENTS
THEY'VE IMPACTED THE CARE OF AND
IMPROVED THE CARE OF.
BUT THEY HAVE.
AND SO, I WOULD JUST EXTEND THAT
CONGRATULATIONS.
>> THANK YOU, DR. AKE.
>> JOHN SLEASMAN.
>> MOSTLY ABOUT ARV USE IN
ADULTS AND PEDIATRICS.
BUT ONE OF THE THINGS THAT CAME
OUT OF THE LISTENING SESSIONS
AROUND THE COUNTRY, RURAL AND
UNDERSERVED AREAS LIKE
MISSISSIPPI IS IN WHILE HIV CARE
IS ADMINISTERED IN HEALTH
DEPARTMENTS AND/OR IN FAMILY
PRACTICE OFFICES OR BY
PHYSICIANS AND PROVIDERS WHO ARE
NOT HIV EXPERTS.
SO HAVING THESE GUIDELINES IS
ESSENTIAL.
AND I GUESS ONE OF THE QUESTIONS
IS, ARE WE DOING A GOOD JOB IN
GETTING THOSE FOLKS TO USE THE
GUIDELINES AS A PRIMARY SOURCE
FOR THE TREATMENT?
AND HOW ARE WE TRACKING THAT?
AND THEN THE SECOND THING IS,
MORE FOR DR.-- IS -- AND I ASKED
THIS QUESTION BEFORE.
IS THAT THE OI USE SEEMS VERY
HIGH SO I SUSPECT THAT PEOPLE
WHO HAVE A -- ARE SURFING OFF
THE HIV GUIDELINES IN ORDER --
FOR PATIENTS WHO DON'T HAVE HIV.
HOW DO WE DEAL WITH THAT IN
TERMS OF RECOMMENDATIONS?
>> MAYBE I CAN ANSWER THE
QUESTION FIRST ABOUT HOW DO WE
TRACK PEOPLE ARE USING THE
GUIDELINES.
NUMBER 1, I DON'T KNOW THE
ANSWER TO THE QUESTION.
BUT SECONDLY IS THE FACT THAT I
KNOW HRSA DEFINITELY THROUGH THE
RYAN WHITE PROGRAM AND -- HAVE
SOME WAYS OF TRACKING WHAT ARE
BEING USED.
AND PERIODICALLY, LAURA ACHIEVER
IS PART OF OUR GUIDELINES PANEL
MEMBER AND SHE IS EXTREMELY
HELPFUL IN GUIDING US WHENEVER
WE HAVE ANY QUESTIONS AS
RELATING TO HOW OUR GUIDELINES
BEING USED BY THE COMMUNITY.
>> INTERESTING THEN, ARE THEY
LOOKING AT HOW THEY ARE BEING
USED IN COMPARED TO THE
GUIDELINES AS A --
>> I CAN BRING IT UP TO HER
ATTENTION BECAUSE OFTENTIMES
WHEN WE ARE WRITING SOMETHING,
SOMETHING THAT SHE ALWAYS POINT
OUT IS THAT THEY WILL BE USING
IT AS THEIR MEASURE WHATEVER WE
RECOMMEND.
FOR INSTANCE, WHEN WE WERE
TRYING TO MAKE RECOMMENDATIONS,
HOW OFTEN DO WE GET VIRAL LOAD
AND CD4 COUNT?
THAT WILL BE ONE OF THE MEASURES
THAT WILL USE IN TERMS OF
FUNDING AND OTHER REASONS AS
WELL.
BUT THE OTHER WAY AROUND WOULD
BE TRYING TO SEE HOW THE
PRESCRIBING IS GOING ON IN
DIFFERENT PARTS OF THE COUNTRY
AND DIFFERENT PROGRAMS THAT WE
SEE FUNDING -- RECEIVE FUNDING.
>> MANY PROVIDERS ARE
CONSTRAINED BY WHAT'S AVAILABLE
IN THEIR STATE MEDICAID, WHICH
IS A REAL PROBLEM.
THAT'S A STORY FOR ANOTHER DAY.
>> I WANT TO ADD THAT SIMILAR
FOR THE PERINATAL GUIDELINES,
THERE IS MEMBERS OF THE
PERINATAL GUIDELINES THAT GO OUT
TO THE HRSA FQHCs AND DO
TRAINING AND/OR PRESENTATIONS ON
UPDATES RELATED TO TREATMENT IN
PREGNANT INDIVIDUALS.
AND THAT IS SUPPORTED BY HRSA AS
WELL.
>> I SEE DR. JONATHAN MERMIN AND
DR. ROHAN HAZRA.
>> THANK YOU.
I WANTED TO ALSO APPRECIATE THE
COLONEL'S COMMENTS ABOUT THESE
GUIDELINES.
THIS IS HARD AND REALLY
MEANINGFUL.
AND COMPLETELY THANKLESS.
SO HERE YOU GET SOME POSITIVE
REINFORCEMENT FOR SOME REALLY
HARD WORK HERE.
I HAD A QUESTION FOR DR. AMAZE
MAS.
YOU MEN MAZUR.YOU MENTIONED YOUG
ON -- SYPHILIS, WHICH ALSO KIND
OF IS COVERED IN CDC'S STI
GUIDELINES AND THE DRAFT
HOPEFULLY SOON-TO-BE FINAL.
AND I MENTION THERE IS DIFFERENT
PLACES IN THE GUIDELINES THAT
YOU'RE LEADING WHERE THERE ARE
OTHER GUIDANCE OUT THERE FROM
OTHER EITHER GOVERNMENT BODIES
OR PROFESSIONAL ORGANIZATIONS.
AND I'M WONDERING, I THINK THESE
GUIDELINES ARE GREAT EXAMPLES OF
LIVING GUIDELINES THAT KEEP
GETTING ADAPTED AS THINGS
CHANGE.
HOW HAVE YOU DEALT WITH THAT?
IS THERE A WAY OF LINKING TO
OTHER GUIDANCE AND SAYING WE
DEFER TO THESE?
BUT THIS IS THEIR MAIN,
CURRENTLY WHAT THEY ARE
COVERING?
WHAT HAPPENS IF YOU FEEL
DIFFERENTLY THAN WHAT THESE
OTHER GUIDELINES MAY SAY?
HOW DO YOU COPE WITH THAT?
>> YOU DON'T COUNT ON YOUR
FRIENDS TO ASK YOU IMPOSSIBLE
QUESTIONS.
SO THANK YOU FOR THAT.
WE WORK VERY CAREFULLY, AS YOU
KNOW WITH JOHN BROOKS, AND JOHN
TRIES TO MAKE SURE THAT WE
COORDINATE CERTAINLY WITH CDC
GUIDELINES.
WHEN YOU SAY DO WE DEFER TO
OTHER GUIDELINES, IT DEPENDS ON
WHO IS PUTTING OUT THE GUIDELINE
AND WHAT IS THE CONTENT.
BUT SINCE CDC AND ITSA ARE
SPONSORING, WE TRY TO HARMONIZE
OUR GUIDELINES.
AS YOU KNOW, THERE ARE CERTAIN
AREAS LIKE TB WHERE WE CAN'T
COME TO CONSENSUS BUT WE TRY IN
A COLLEGIAL WAY TO STATE THAT
THERE ARE DIFFERENCES OF
OPINIONS.
THIS IS OUR OPINION.
BUT CDC HAS A DIFFERENT OPINION.
THERE ARE NOT VERY MANY
SITUATIONS LIKE THAT.
AND PARTICULARLY WITH STDs, WE
RECOGNIZE THAT CDC HAS
HISTORICALLY ALWAYS BEEN THE
SOURCE OF GUIDELINES.
SO I THINK THAT IS AN AREA WHERE
WE ARE UNLIKELY TO HAVE
SOMETHING OTHER THAN A LINK.
BUT WE ALSO FEEL THAT PEOPLE
DON'T LIKE TO JUMP AROUND TOO
MUCH FROM ONE GUIDELINE TO
ANOTHER.
SO WE WILL PUT SOMETHING IN
THERE BUT I THINK I'M TRYING TO
THINK IF THERE IS ANY SITUATION
WITH STDs WHERE WE DIFFER FROM
CDC.
BECAUSE THEN IT GETS CONFUSING
FOR A CLINICIAN.
BUT I THINK MOST OF THE TIME
WHERE WE DISAGREE EVEN ABOUT TB,
IS SOMETHING RELATIVELY ESOTE
ESOTERIC.
>> ONE THING THAT IS SOMEWHAT
SIMILAR THAT IS THAT ONE THING
WE OFTENTIMES FIND DIFFICULT IS
THAT DIFFERENT GUIDELINES ARE
UPDATED AT DIFFERENT TIMES.
WHEN NEW INFORMATION BECOMES
AVAILABLE, YOU MAY HAVE ONE
GUIDELINE THAT DECIDES THEY ARE
GOING TO HAVE TO UPDATE BUT THE
OTHER IS NOT READY YET.
SO YOU WILL HAVE INFORMATION
FROM DIFFERENT GUIDELINES WHERE
THE CLINICIANS WILL GO TO ONE
PLACE AND SAY, NOW WHICH ONE AM
I GOING TO FOLLOW BECAUSE OF
THAT?
AND THAT IS UNAVOIDABLE AND WE
TRY TO DO THE BEST WE CAN TO
MAKE SURE WE WILL HAVE SOME
HARMONIZING OF SOME THESE
GUIDELINES THAT IS NEVER EASY TO
DO.
>> AND ONE COMMENT TO THAT.
I SUSPECT THAT ALL THE GUIDELINE
PANELS ARE GRATEFUL WITH THE
FACT THAT OAR PROVIDES
ADMINISTERS THE UPDATES.
PROFESSIONAL SOCIETIES STRUGGLE
WITH THIS ISSUE OF UPDATING
GUIDELINES AND SOME OF THEM, THE
GUIDELINES ARE LUCKY IF THEY ARE
UPDATED EVERY TWO OR THREE YEARS
AND SOMETIMES YOU'RE LOOKING AT
MORE THAN FIVE YEARS.
SO ONE OF THE STRENGTHS OF THESE
GUIDELINES IS THAT WE CAN UPDATE
NEW INFORMATION AND ON THE RARE
OCCASIONS WHERE WE HAVE WRONG
INFORMATION, WE CAN CORRECT IT.
AND AGAIN, THAT'S BECAUSE WE
HAVE SUPPORT THAT VERY FEW OTHER
GUIDELINES PANELS HAVE.
AND I THINK WE HAVE TO RECOGNIZE
THAT IS AN IMPORTANT PART OF THE
INVESTMENT, WHICH OAR HAS BEEN
WILLING TO MAKE.
>> THANK YOU.
WE HAVE ONE FINAL QUESTION FROM
DR. ROHAN HAZRA.
>> THANK YOU.
THIS IS JUST A COMMENT TO
DR. JOHN SLEASMAN'S QUESTION
ABOUT HOW THE GUIDELINES ARE
USED.
AND WE HEARD ABOUT THE FACTS
COHORT EARLIER THAT FOLLOWS
ACQUIRED IN CHILDREN AND YOUNG
ADULTS AND PERINATALLY-ACQUIRED
INFECTION.
BUT ALSO PREGNANT PEOPLE WITH
HIV AND FOLLOWING THEIR HIV
EXPOSURE IN UNINFECTED INFANTS
AND CHILDREN.
AND AN ANALYSIS LOOKED AT HOW
WELL THE -- HOW THE TREATMENTS
DURING PREGNANCY AND THE FACTS
COHORDE ALIGNED OR DIDN'T ALIGN
WITH THE GUIDELINES.
AND AT THAT TIME, ABOUT A THIRD
OF WOMEN WERE ON REGIMENS OF
INSUFFICIENT DATA TO RECOMMEND
OR NOT RECOMMENDED AT ALL.
I THINK IN PREGNANCY, THAT IS
PROBABLY SHOWING YOU THE LACK OF
CONVINCING DATA TO PUT CERTAIN
REGIMENS IN THE GUIDELINES AND
THESE ARE CLINICIANS THAT ARE
OUT FRONT IN FRONT OF THE
GUIDELINES.
AND I THINK IT'S AN AREA THAT OF
COURSE USE OF MEDICATIONS IN
PREGNANCY WE'RE ALWAYS GOING TO
BE FIGHTING AGAINST.
THAT IS ONE ANALYSIS THAT
CLEARLY SHOWED MISALIGNMENT
BETWEEN WHAT IS BEING DONE IN
PRACTICE VERSUS WHAT IS BEING
RECOMMENDED.
>> THANK YOU.
THANK YOU VERY MUCH.
THANK YOU ALL FOR SUCH A LIVELY
DISCUSSION.
AS WE BEGIN TO CLOSE OUR MEETING
FOR TODAY, THIS PARTICULAR TIME
HAS BEEN ALLOTTED FOR PUBLIC
COMMENT.
DR. HOLTZ, HAVE WE RECEIVED ANY
COMMENTS FOR TODAY'S MEETING?
>> THANK YOU DR. TURNBULL.
WE DO NOT HAVE ANY PUBLIC
COMMENTS FOR TODAY'S MEETING.
>> OKAY.
>> NO COMMENTS?
I JUST WANT TO QUICKLY NOTE FOR
OARAC MEMBERS TO KINDLY RETURN
YOUR CONFLICT OF INTEREST FORMS
AT THE CLOSE OF THE MEETING AND
PLEASE NOTE THE NEXT PUBLIC
MEETING IS ON THURSDAY, JUNE 20,
2024.
BEFORE I TURN THE MEETING BACK
TO DR. TURNBULL, I'D LIKE TO
THANK THE MEMBERS FOR YOUR
PARTICIPATION IN OAR'S ADVISORY
COUNCIL.
THIS IS A TRANSFORMATIONAL TIME
AND EVERYONE'S INPUT IS VITAL.
I WOULD LIKE TO THANK DR. FINSY
FOR HER LEADERSHIP, CAPTAN
GLENNSHAW FOR HER WILLINGNESS TO
STEP IN AS ACT WELL DEPUTY GOING
FORWARD AS WELL AS THANK ALL MY
FELLOW COLLEAGUES IN OAR AND THE
NIH AIDS EXECUTIVE COMMITTEE FOR
THE PRIVILEGE OF WORKING WITH
THEM FOR THE PAST FIVE YEARS.
AND MOST PARTICULARLY, MY FELLOW
STAFF THAT SUPPORT THIS
COUNCIL'S REGULAR MEETINGS AND
THE IMPORTANT ADVISORY
RESPONSIBILITIES TO THE NIH OAR
CODIFIED IN THE CHARTER.
DR. TURNBULL, OVER TO YOU FOR
CLOSING REMARKS.
AND THANK YOU AGAIN.
>> THANK YOU ALSO, TIM.
THANK YOU EVERYONE FOR A
FANTASTIC AND INFORMATIVE
MEETING TODAY.
WE APPRECIATE YOUR CONTINUED
FEEDBACK AND THE GREAT DIVERSITY
OF PERSPECTIVES AND INPUT.
TODAY'S MEETING IS NOW
ADJOURNED. 4449 02:58:51,654 THANK YOU ALL.