>> GOOD MORNING AND GOOD
AFTERNOON EVERY ONE.
MY NAME IS MARY GLENSHAW I'M
THE EXECUTIVE SECRETARY OF THE
OFFICE OF AIDS RESEARCH
ADVISORY COUNCIL, THE OARAC,
WELCOME.
THANK YOU FOR PARTICIPATING
TODAY.
AS A BRIEF REMINDER OUR COUNCIL
IS GOVERNED BY THE ACT WHICH
SETS FORTH THE FORMATION AND
ADVISORY COMMITTEES.
ANY ROLE TO IS PREPARE
MEETINGS, ORGANIZE ATTEND AND
APPROVE ALL COUNCIL ACTIONS,
ADJOURN ANY MEETING WHEN IT'S
DEEMED TO BE IN PUBLIC INTEREST
AND CHAIR MEETINGS WHEN
DIRECTED BY THE NIH OR OAR
DIRECTOR.
SO AS PREVIOUS MEETINGS LET'S
GO OVER SOME GENERAL GUIDELINES.
AS THIS IS A VIRTUAL MEETING,
PLEASE STAY MUTED UNLESS YOU'RE
SPEAKING.
PLEASE KEEP YOUR CAMERA FOR
MOST OF THE MEETING, YOU MAY
HIDE IT WHEN YOU NEED TO BUT
TURN IT BACK ON WHEN YOU CAN.
WHEN YOU WANT TO PARTICIPATE IN
DISCUSSIONS, WE ASK YOU TO USE
THE ZOOM RAISE HAND FEATURE.
SO WE AVOID SPEAKING OVER EACH
OTHER.
PLEASE, BE AWARE THAT YOU'LL
NEED TO LOWER YOUR HAND
VIRTUALLY ONCE YOU'VE MADE YOUR
REMARKS.
WE HAVE THE CHAT FEATURE
DISABLED EXCEPT FOR LOGITIC
MESSAGES, IF YOU NEED ANYTHING,
FEEL FREE TO ACCEPTED ME AN
EMAIL.
YOU CAN ALSO EMAIL OARAC @
NIH.GOV.
FOR EVERY ONE ON VIDEO CAST IF
YOU WOULD LIKE TO USE THE CLOSE
CAPTION FEATURE, PLEASE CLICK
ON THE CC ICON WHICH IS ON THE
RIGHT HAND BOTTOM CORNER OF THE
SCREEN.
SO FOR MEMBERS, I WOULD LIKE TO
REMIND YOU OF POLICIES
RECORDING CONFLICT OF INTEREST.
COUNCILMEMBERS MAY NOT
PARTICIPATE IN THE SPECIFIC
PROJECT FOR WHICH YOU HAVE A
REAL OR PARENT CONFLICT OF
INTEREST.
IF A PROGRAM OR PROJECT IS
DISCUSSED THAT PRESENTS A
CONFLICT, PLEASE EXCUSE
YOURSELF AND TO DO THIS, PLEASE
SIGNAL ME AND WE'LL MOVE TO YOU
A SEPARATE SPACE.
AFTER THE MEETING, SIGN THE
FORM THAT WE WILL BE SENDING
YOU LATER TODAY.
THIS WILL VERIFY THAT NOTHING
SAID TODAY WILL POSE A CONFLICT
FOR YOU.
ARE THERE ANY QUESTIONS
REGARDING CONFLICT OF INTEREST
REGARDING TODAY'S AGENDA?
OKAY, HEARING NONE.
PLEASE ALSO, REMEMBER THAT
TODAY'S MEETING IS OPEN TO THE
GENERAL PUBLIC AND IS CURRENTLY
BEING RECORD ASKED VIDEO CAST
LIVE.
I'M HAPPY TO TURN OUR MEETING
OVER TO THE OARAC CHAIR TO
BRING THE MEETING TO ORDER,
THANK YOU.
>> THANK YOU, DR. GLENSHAW.
AND GOOD AFTERNOON, THE 67th
MEETING OF THE AIDS ADVISORY
COUNCIL OARAC, IS NOW IN
SESSION.
WELCOME COUNCILMEMBERS, INVITED
SPEAKERS AND GUESTS.
COLLEAGUES WE WILL NOW CONDUCT
A ROLL CALL, I'M TURNING BACK
OVER TO DR. GLENSHAW, WOULD YOU
PLEASE PROCEED WITH THE ROLL
CALL.
>> YES, MA'AM, THANK YOU.
SO FAR STANDING MEMBERS AND
GUESTS, WHEN WE CALL YOUR NAME,
PLEASE STATE YOUR POSITION AND
YOUR INSTITUTIONAL AFFILIATION.
I'M DELIGHTED THAT IN THIS
FIRST PART OF THE ROLL CALL, WE
HAVE FOUR NEW VOTING MEMBERS,
STARTING WITH THE VERY FIRST
TWO IN ALBA BET CAL ORDER, DR.
COURTNEY FLETCHER.
>> PRESENT, PROFESSOR
UNIVERSITY OF NEBRASKA MEDICAL
CENTER.
>> WELCOME.
DR. SONIA FLORES.
>> HI, WELCOME EVERYBODY.
I'M AT THE UNIVERSITY OF
COLORADO AND CAMPUS AND I'M A
PROFESSOR IN THE DEPARTMENT OF
MEDICINE.
>> THANK YOU, WELCOME.
DR. OMAR GALARRAGA.
>> BROWN UNIVERSITY PUBLIC
HEADLIGHT.
>> WELCOME THANK YOU.
>> DR. LOUIS MONTNTANER?
>> I'M PROFESSOR OF WINDSOR
INSTITUTE AND DIRECTOR OF
DISEASE CENTER.
?FM WELCOME.
>> DR.
>> PROFESSOR AND CHAIR OF
GENEALOGY AT JOHN HOPKINS.
>> HI, I'M A PROFESSOR OF THE
DEPARTMENT OF MINE AT
NORTHWESTERN UNIVERSITY.
>> WELCOME.
>> DR. ANNE MULE
>> I'M A PHYSICIAN AT
MASSACHUSETTS GENERAL HOSPITAL
AND INFECTIOUS DISEASE SXZ
ASSISTANT PROFESSOR AT
PEDIATRICS AT HARVARD MEDICAL
SCHOOL.
>> WELCOME AND OUR LAST TWO
NEWEST VOTING MEMBERS, DR.
DIANE FINZI.
>> UNFORTUNATELY WE CANNOT HEAR
YOU.
WE KNOW THAT YOU'RE HERE.
SO WE'LL CIRCUMSTANCING BACK TO
YOU.
DR. SARAH SAWYER.
>> HEY GOOD I'M SARAH WATER I'M
A PROFESSOR AT THE UNIVERSITY
OF COLORADO BOULDER.
>> THANK YOU.
WE'LL MOVE TO OUR OARAC
OFFICIOS.
DON'T THINK SHE HAS JOINED US
YET.
CARL JULIE ACHE?
>> GOOD MORNING, EVERY ONE.
OR AFTER I'M I'M INFECTIOUS
DISEASE PHYSICIAN AND DIRECTOR
OF THE INSTITUTE RESEARCH.
>> WELCOME.
>> DR. VICKY GAVI.
>> VICKY GAVE' I'M ASSOCIATE
CHIEF RESEARCH FOR VA AND
EX-OFFICIO FROM THE DEPARTMENT
OF VETERANS AFFAIRS.
THANK YOU.
>> THANK YOU, WELCOME.
>> DR. CARL?
>> GOOD AFTERNOON, I'M DIRECTOR
OF DIVISION OF AIDS OF
INSTITUTION OF INFECTIOUS
DISEASES.
>> THANKS, WELCOME.
DR. JONATHAN?
>> GOOD AFTERNOON, I'M JONATHAN
AND I'M DIRECTOR OF THE
NATIONAL CENTER FOR HIV AND S
T.D.s.
>> THANK YOU.
>> GOOD AFTERNOON, GOOD I'M
ROJAN I'M AT THE KENNEDY
NATIONAL INL STAOULT OF CHILD
HEALTH AND DEVELOPMENT.
HERE AT NIH WHERE I'M THE
DIRECTOR OF RESEARCH.
>> WELCOME, THANK YOU.
>> OUR ADVISORY COUNCIL
REPRESENTATIVES I'M NOT SURE
DR. MARGARITA LIGHTFOOT IS ON
YET.
I THINK NOT YET.
BUT I DO SEE DR. MELONY.
>> YES, HELLO EVERY ONE I'M
DIRECTOR OF GLADSTONE OF
VIROLOGY AND PROFESSOR AT UCSF
AND I REPRESENT NAFTA.
>> THANK YOU, I WILL MOVE ON TO
OUR LEADERS AND SPEAKERS.
IT'S OUR MY GREAT PLEASURE TO
WELCOME OUR NEW DIRECTOR.
>> WELCOME EVERYBODY, I'M
EXCITED TO BE HERE AND I'LL
PRESENT A LITTLE BIT MORE ON
MYSELF LATER.
>> THANK YOU.
>> WE ALSO HAVE SOME OTHER
SPEAKERS AND GUESTS FROM OAR.
>> I'M A HEALTH SCIENTIST HERE.
>> WELCOME.
AND I DON'T SHE HAS MADE IT YET
BUT WE'LL BE HEARING FROM MS.
CARETA.
AND LASTLY SOME OF OUR SPECIAL
GUEST FOR TODAY'S MEET ING,
OUR MOST RESENT DIRECTOR, DR.
FINZARAH I.
>> NICE TO SEE YOU, I WAS THE
ACTING DIRECTOR BUT NOW I'M
BACK TO MY PREVIOUS POSITION AS
DIRECTOR OF SCIENCES PROGRAM IN
THE DIVISION OF AIDS.
>> THANK YOU.
DR. WESLEY WSUNDQUIST.
>> HI EVERY ONE I'M CHAIR OF
CHEMISTRY AT THE UNIVERSITY OF
UTAH AND I DIRECT ONE OF THE
HIV CENTERS WITHIN THE DADES
PROGRAM.
>> THANK YOU FOR JOINING US
TODAY.
OUR LAST THREE GUESTS, I DON'T
BELIEVE ARE ON YET.
THEY ARE DR. TRIP COOLIC, DR.
DONNIE READY AND FRANKLIN YATES.
IS THERE ANYONE THAT WE DID NOT
ANNOUNCE?
OKAY, WONDERFUL, WITH YOU,
TURNBULL BACK TO YOU.
>> THANK YOU, AS A REMINDER OUR
CHARTER AND LEGISLATION, DIRECT
ON BOARD MATTERS RELATING TO
H.I.V. POLICIES AND STRATEGIC
PLANNING INCLUDING THE REVIEW
OF NIHHIV PROGRAMS.
I WILL NOW PROVIDE OVERVIEW OF
TODAY'S AGENDA.
WHICH WILL INCLUDE A REPORT
FROM OAR DIRECTOR.
A PRESENTATION FROM DR. WESLEY
WSUNDQUIST, CO-CHAIR OF
BIOCHEMISTRY UNIVERSITY OF UTAH
SCHOOL OF MEDICINE.
PRESENTATION FROM THE OAR TASK
FORCES RECORDING
RECOMMENDATIONS FOR THE
STRATEGIC PLAN FOR H.I.V.
RESEARCH.
FOLLOWING THIS SEGMENT, THERE
WILL BE A SPECIAL PRESENTATION
FROM THE AIDS RESEARCH
ADVISORY'S COMMITTEE FOLLOWED
BY OTHER ADVISORY COUNCIL
UPDATES AND FINAL LEE ANNE
UPDATE FROM THREE OF THE OARAC
CLINICAL GUIDELINES WORKING
GROUPS.
THE AGENDA ALSO INCLUDES TIME
FOR REGISTERED PUBLIC COMMENT.
ANYONE LISTENING TODAY WHO
WISHES TO MAKE A PUBLIC COMMENT
SHOULD EMAIL OARACINFO @ NIH
DOT GOV, WITH YOUR NAME AND O
FILLATION AND QUESTION OR
COMMENT.
PLEASE VISIT NIH WEBSITE FOR
THE FEDERAL REGISTRY NOTICE FOR
MORE DETAIL.
VERY EXCITED TO ANNOUNCE THAT
TODAY, MARKS THE FIRST OARAC
MEETING FOR THE NEW PERMANENT
DIRECTOR, DR. GERI DO NOTENBERG.
TO INTRODUCE HER, PLEASE
WELCOME DR. SCHETZ.
>> NOT SURE IF SHE'S ON YET.
>> CAN I JUST TAKE A QUICK
MOMENT, TO OUR AV COLLEAGUES,
I'M GETTING A LOT OF MESSAGES
THAT THE VIDEO CAST IS NOT
WORKING.
SO IF SOMEBODY COULD ADJUST
THAT, THAT WOULD BE GREAT.
>> THERE WAS, THERE WERE TWO
VIDEO CASTS EMAILS AND ONE WAS
CANCELED AND ONE IS WORKING.
SO I DON'T KNOW, WHAT WHAT
HAPPENED BUT, I TRIED TO LOG ON
TO THE ONE THAT WAS CANCELED
SEVERAL TIMES.
BUT--.
>> WE'LL GET IT STRENGTHENED
OUT AND CIRCULATE IT, THANKS.
IF YOU WANT TO PROCEED WE'LL
CONTINUE WITH DR. SCHETZWHEN
SHE COMES ON.
>> THANK YOU, I'LL BE HAPPY TO.
ARE MY SLIDES AVAILABLE?
OKAY, WELL WELCOME EVERY ONE.
I AM DELIGHTED TO BE HERE.
THIS IS MY FIRST MEETING OF
OARAC BUT ALSO AS THE NEW
DIRECTOR.
BUT IT'S ALSO THE FINAL OARAC
MEETING OF THE CALENDAR YEAR.
AND I'M DEEPLY HONORED TO STEP
IN THE ROLE AS NIH OFFICE OF
AIDS RESEARCH.
I'M EAGER TO BUILD ON WHAT
OTHERS HAVE ALREADY
ACCOMPLISHED AND HOPING THAT
TOGETHER WITH ALL OF YOU, WE
WILL ENSURE THAT THE HIV AGENDA
MEETS THE NEEDS OF THE EPIDEMIC.
I'M A CLINICAL PSYCHOLOGIST BY
TRAINING, I ATTENDED THE
UNIVERSITY IN MICHIGAN AT ANN
ARBOR AS UNDERGRAD AND RECEIVED
MY MASTERS AND Ph.d FROM UCLA.
AND I HAVE SPENT PRETTY MUCH
THE PAST 25 YEARS IN THE
ACADEMIA IN THE UNIVERSITY OF
CHICAGO.
SXL IT SPANS ABOUT THREE
DECADES OF NIH RESEARCH
ADDRESSING EACH STAGE OF THE
CONTINUUM AT SOME POINT OR
ANOTHER.
I FOCUS ON ADOLESCENT AND YOUNG
ADULTS BUT INTEGRATED MENTAL
HEALTH AND SOCIAL DETERMINANTS
OF HEALTH INTO MOST OF MY
STUDIES AND OVER THE COURSE OF
MY CAREER, I HAVE DEVELOPED AND
DEVELOPED AND TESTED
INTERVENTIONS AND CLINICAL
TRIALS EFFECTIVENESS TRIALS,
HYBRID IMPLEMENTATION, MOST
HAVE FOCUSED ON REDUCING
ADOLESCENT RISK THAT IS
ASSOCIATED WITH TRANSMITTING
HIV AND ALSO REDUCING VIRAL
LOAD.
AND I WOULD LIKE TO POINT OUT
THAT MOST OF MY WORK HAS BEEN
CARRIED OUT IN ALMOST
EXCLUSIVELY REAL PRACTICE
RESOURCE CONSTRAINT SETTINGS,
BOTH IN URBAN AREAS IN U.S. BUT
ALSO GLOBALLY PARTICULARLY IN
AFRICA AND IN ALL OF THAT WORK,
WORKING IN CLOSE COLLABORATION
WITH MEMBERS INCLUDING MEMBERS
WITH HIV.
MOST RECENTLY I FOUNDED AND
DIRECTED THE CENTER FOR DID I
SEM NATION AND IMPLEMENTATION
SCIENCE IN AT UNIVERSITY OF
ILLINOIS, CHICAGO.
AND THE MISSION OF OUR CENTER
IS TO ADVANCE IMPLEMENTATION
SCIENCE RESEARCH, PRACTICE AND
EDUCATION AND PARTNERSHIP WITH
COMMUNITIES TO REDUCE HEALTH
DISPARITIES .D AND I MENTION
THAT BECAUSE AS THE DRIVER OF
THE CENTER AND THE MISSION, I
THINK IT'S IMPORTANT THAT I
THAT I SHARE WITH YOU WHERE MY
POSITION WHERE MY POSITION IS
IN THESE ISSUES AND IN THE
EPIDEMIC.
AS MOST OF YOU KNOW, THERE IS A
PRETTY SIGNIFICANT TIME LAPSE
BETWEEN WHEN A SCIENTIFIC
INNOVATION IS DISCOVERED OR
DEVELOPED AND THEN LIKE LET'S
SAY PREP AND BY THE TIME IT
GETS DELIVERED AND PRACTICED.
IF IT EVER GETS DELIVERED AND
PRACTICED.
AND THE CONCERN OF COURSE IS
THAT THIS GAP IS LOSES AN
ENTIRE GENERATION OF
INDIVIDUALS WHO MIGHT HAVE
BENEFITED FROM IT.
BUT IT ALSO ENDS UP BEING LEAST
LIKELY TO REACH AND BENEFIT THE
POPULATIONS THAT NEED IT THE
MOST.
AND SO THE ABSENCE OF EQUITY IN
THIS RESEARCH AND UP TAKE OF
THESE INTERVENTION SOUTH SIDE
GRAVELY CONCERNING.
AND I'M HOPEFUL THAT AS WE MOVE
INTO THIS NEXT PHASE OF THE
H.I.V. RESEARCH WE'RE GOING TO
ADDRESS THIS HEALTH IMPERATIVE.
SO I'M PASSIONATE ABOUT
ADVANCING EVIDENCE BASE
INTERVENTION THAT'S MAKE A
GLOBAL IMPACT, ESPECIALLY IN
LOW RESEARCH SETTINGS AND THAT
BUILD CAPACITY WITHIN THOSE
SETTINGS TO ACTUALLY SUSTAIN
AFFECTIVE TREATMENT AND USING
IMPLEMENTATION SCIENCE WE CAN
DRIVE FORWARD NIH'S EFFORT TO
ACHIEVE HIV CONTROL.
SO THAT'S A BACKGROUND ABOUT ME.
I WANT TO TAKE A MOMENT TO NEXT
SLIDE, PLEASE.
I WANT TO TAKE A MOMENT TO
THANK AND ACKNOWLEDGELE DR.
FINZI'S ROLE AND HARD WORK AS
THE ACTING OAR DIRECTOR, I HAD
THE GREAT FORTUNATE OF MEETING
HER AT THE INTERNATIONAL
SOCIETY MEETING THIS PAST, I
THINK IT WAS JULY.
AND JUST SO IMPRESSED BY HER
DEDICATION AND HER WORK AND THE
COUNTLESS INITIATIVES THAT THEY
REALLY LEAD DURING HER TENURE
AS ACTING DIRECTOR.
SO I'M HOPING WE CONTINUE TO
WORK TOGETHER WHILE YOU
TRANSITION BACK INTO YOUR ROLE
AS DIRECTOR OF THE BASIC
SCIENCES PROGRAM.
AND MANY MANY THANKS TO YOU FOR
YOUR SUPPORT AND YOUR
LEADERSHIP DURING THIS
TRANSITION.
NEXT SLIDE, PLEASE.
I WOULD ALSO LIKE TO FORMALLY
WELCOME AND INTRODUCE OUR FOUR
NEW OARAC MEMBERS.
WE ARE SO FORTUNATE TO HAVE YOU
WORKING WITH US.
I HE YOU PRESENTED A LITTLE BIT
BUT I'LL ADD TO THAT.
DR. COURTNEY FLETCHER IS A
PROFESSOR OF PHARMACY IN THE
COLLING OF PHARMACY AND
MEDICINE AND DIRECTOR OF ANTI
VIRAL PHARMACOLOGY LABORATORY
AT THE UNIVERSITY OF NEBRASKA
MEDICAL CENTER FOR DRUG
DISCOVERY.
HE'S DEVOTED HIS RESEARCH AND
PRACTICE WHERE THE CLINICAL
PHARMACOLOGY OF ANTI VIRAL
AGENTS AND RECEIVED HIS DOCTOR
OF PHARMACY FROM THE UNIVERSITY
OF MINNESOTA IN MINNEAPOLIS.
NEXT WE HAVE SONIA FLORES WHO
IS A PROFESSOR OF MEDICINE AND
MICROBIOLOGY AT THE UNIVERSITY
OF COLORADO IN DENVER.
DR. FLORES WORK HAS FOCUSED ON
EQUITY AND INCLUSION WITHIN THE
BASIC SCIENCES AND H.I.V.
COMORBIDITY ISSUES.
SHE RECEIVED HER DOCTORAL
DEGREE FROM THE UNIVERSITY OF
ALABAMA.
NEXT IS DR. DIANE SANTA MARIA
WHO IS A DEAN AT THE PHYSICS
SCHOOL OF NURSING, HER RESEARCH
INTEREST INCLUDE WORKING IN
UNDER SERVED COMMUNITIES IN THE
U.S. COMMUNITIES CONDUCTING
H.I.V. AND REDUCTION WITH YOUTH
AND YOUNG ADULTS EXPERIENCING
HOMELESSNESS.
SHE BRINGS EXPERTISE IN
ADOLESCENT HEALTH HIV, STI
PREVENTION AND PREDICT I HAVE
MODELING.
RECEIVED HER DRPH IN THE
UNIVERSITY OF TEXAS IN THE
SCHOOL OF PUBLIC HEALTH.
AND THEN LAST BUT OF COURSE NOT
LEAST, WE HAVE SARAH SAWYER WHO
IS A PROFESSOR AT THE
UNIVERSITY OF COLORADO BOULDER.
SHE HAS RECEIVED NATIONAL SXINT
NATIONAL PRIZES IN VIRALOLOGY
INCLUDING THE PRESIDENTIAL
EARLY CAREER AWARD FOR
SCIENTIST AND ENGINEER FROM
PRESIDENT BARACK OBAMA IN 2001,
AND ALSO RECEIVED NIH
DIRECTOR'S PIONEER AWARD IN
2022.
HER RESEARCH FOCUSES ON H.I.V.
1 VACCINE MODELS INCLUDING A
RECENTLY ESTABLISHED ACUTE AND
CHRONIC H.I.V. 1 INFECTION IN
OWL MONKEYS AND HOLDS A Ph.d
FROM CORNELL UNIVERSITY.
SO WELCOME COLLEAGUES AND WE'RE
LOOKING TO ENGAGEMENT AND
PRODUCTIVE COLLABORATIONS.
NEXT SLIDE PLEASE.
SO YOU'LL SEE THAT WE HAVE A
PRETTY PACKED AGENDA.
WE'RE GOING TO START WITH A
DIRECTOR'S REPORT WHICH I WILL
GIVE.
THEN WE'RE GOING TO HEAR A
PRESENTATION ABOUT THE
STRUCTURE FUNCTION AND
INHIBITION OF THE H.I.V. ONE
CAPSID FROM DR. WSUNDQUIST.
NEXT WE'RE GOING TO HEAR FROM
OUR STRATEGIC PLAN TASK FORCE
THAT'S WERE CREATE TODAY
--CREATED TO HELP GUIDE THE
IDEAS BEHIND THE PLAN.
AND LASTLY, WE ARE GOING TO
HEAR SOME UPDATES FROM THE
H.I.V. ADVISORY COUNCIL AND
ALSO THE CLINICAL GUIDELINES.
NEXT SLIDE, PLEASE.
ALL RIGHT.
SO MY REPORT TODAY WILL COVER A
FEW DIFFERENT POINTS, ONE I'M
GOING TO HAVE A NICE
ANNOUNCEMENT TO SHARE AS WELL
AS GO INTO THE MISS CAL YEAR
2026NIH, H.I.V. ELECTIVE.
AND THEN ENGAGEMENT THAT THEY
HAVE HAD IN THE LAST YEAR AND
ALSO ENGAGEMENT TO SHARE OUR
VISION AS WE'RE MOVING FORWARD
WITH THE RESEARCH PORTFOLIO.
AND THEN YOU'RE GOING TO HEAR
ABOUT SOME STRATEGIC PLAN
DEVELOPMENTS AND UPDATE.
NEXT SLIDE, PLEASE.
SO EXCITINGLY, WE ARE ABLE TO
ANNOUNCE THE APPOINTMENT OF DR.
SARAH READ AS PRINCIPAL DEPUTY
DIRECTOR OF THE NATIONAL
DIRECTOR OF INFECTIOUS DISEASES.
SHE WILL BE WORKING ALONGSIDE
DR. MARATSO TO OVER SUE THE
NYADED PROGRAMS AND INITIATIVES.
NEXT SLIDE PLEASE.
SO MOVING ON TO THE
PROFESSIONAL JUDGMENT.
IS IT POSSIBLE TO JUST SEE IF
ANYONE HAS ANY QUESTIONS?
I FEEL LIKE I'M I DON'T KNOW
HOW THIS WORKS EXACTLY BUT IT
SEEMS LIKE A GOOD POINT TO SEE
IF THERE ARE ANY QUESTIONS.
CAN PEOPLE PUT QUESTIONS IN THE
CHAT?
>> THEY ACTUALLY CANNOT.
>> OH OKAY.
>> AND WE DO HAVE TIME AT THE
END FOR Q & A.
>> OKAY, THANK YOU.
EACH YEAR OUR OFFICE PREPARES A
PROFESSIONAL JUDGMENT BUDGET
THAT IS WHERE WE ESTIMATE THE
NEEDS, THE FUND NEEDS TO FULLY
PURSUE THE GOALS OF THE AGENDA.
SO YOU MAZE RECALL THAT DR.
FINZI HAD IN THE JUNE MEETING
AND NOW THE DOCUMENT HAS BEEN
RELEASED AND AVAILABLE ON THE
WEBSITE.
YOU CAN SCAN THE QR CODE IF YOU
WOULD LIKE TO LEARN MORE ABOUT
IT, IT'S ON THE SCREEN.
THE PROFESSIONAL JUDGMENT
BUDGET IS BASED SOLE REON
CURRENT RESEARCH OPPORTUNITIES
AND NIH, H.I.V. PRIORITIES.
IT'S REFERRED TO AS THE
PROFESSIONAL BUDGET BECAUSE IT
REPRESENTATIVES THE
PROFESSIONAL BUDGET OF OAR AND
PRESENTED DIRECTLY TO THE
PRESIDENT WITHOUT MODIFICATION
THROUGH FEDERAL PROCESSES.
THE PROFESSIONAL JUDGMENT
BUDGET IS ONE OF TWO BUDGETS
THAT OUR OFFICE CREATES.
THE SECOND ONE IS CALLED THE
CONGRESSIONAL BUDGET
JUSTIFICATION AND THAT SUPPORTS
THE NIH, H.I.V. BUDGET TO
CONGRESS.
THE 26 PROFESSIONAL BUDGET IS
STRUCTURE TO ALIGN WITH THE
STRATEGIC GOALS IN THE NEXT
ADORATION OF THE STRATEGIC
PLAN WHICH YOU'LL HEAR ABOUT
LATER TODAY.
IT INCLUDES FUNDAMENTAL
RESEARCH TO PROMOTE DISCOVERY
AND H.I.V. SCIENCE AND INCLUDES
PSYCHOSOCIAL I DON'T VARIABLES
AS WELL AND BEHAVIORAL RESEARCH
AS WELL AS, BASIC OTHER BASIC
SCIENCES.
DEVELOPMENT AND ASSESSMENT OF
NOVEL INTERVENTIONS FOR
PREVENTION AND TREATMENT OF
H.I.V. AND COOCCURING
DIVISIONS, AND IMPLEMENTATION
RESEARCH TO OPTIMIZE PUBLIC
HEALTH IMPACT AND THEN
WORKFORCE DEVELOPMENT AND
INFRASTRUCTURE TO ENHANCE
CAPACITY AND INCREASE DIVERSITY.
NEXT SLIDE, PLEASE.
SO AT THIS POINT, I JUST WANT
TO HIGHLIGHT SOME OF THE OUR
ENGAGEMENTS THAT WE'VE BEEN
INVOLVED IN.
WE'VE BEEN PRETTY BUSY.
SO YOU SEE HERE, THESE ARE JUST
A SELECT NUMBER BUT IF YOU WANT
TO LEARN MORE ABOUT THE EVENTS
THAT I'M HIGHLIGHTING HERE,
PLEASE USE THE QR CODE.
THE FIRST THAT YOU SEE HERE IS
THE U.S. CONFERENCE ON H.I.V.
AND AIDS, THAT WAS IN SEPTEMBER
IN NEW ORLEANS AND WE
PARTICIPATED IN A SESSION
TITLED A FEDERAL UPDATE ON
H.I.V. PROGRAMS AND TAKING A
SIN DEMIC APPROACH.
WE ALSO CONDUCTED LISTENING
SESSIONS FOCUSED ON TRIBAL
HEALTH IN PARTNERSHIP WITH NIH
TRIBAL HEALTH AND INDIAN
SERVICE.
WE LISTENED AND HEARD ABOUT
THEIR PREFERENCES AND CONCERNS.
ANOTHER ACTIVITY WE ENGAGED IN,
WE HOSTED A THE INNOVATION AND
H.I.V. RESEARCH IMPOSIUM THAT
WAS HELD IN ROCKFIELD AS PART
OF THE NIH FESTIVAL.
THAT PARTICULAR ACTIVITY
FEATURED INTERIM MURAL
INVESTIGATORS WHO RECEIVED
INNOVATION AWARDS.
ALSO HAD 16 PRESENTATIONS
COVERING VERY DIVERSE TOPICS
FROM VIRALOLOGY, DATA SCIENCE
AND COMOORE BITITY AND
COINFECTIONS.
THE SYMPOSIUM HIGHLIGHTED THE
PROGRAMS IMPACT AND FOSTERING
INNOVATIVE RESEARCH WITH THE
POTENTIAL TO ADVANCE THE H.I.V.
CARE CONTINUUM AND THE
PARTICIPANTS REPORTED REALLY
APPRECIATING FROM THE H.I.V.
COMMUNITY.
AND MULTIPLE OTHER INSTITUTES
ALSO PARTICIPATED.
NEXT SLIDE, PLEASE.
WE ALSO PARTICIPATED IN THE
AIDS 2024 MEETING OF THE
INTERNATIONAL AIDS CONFERENCE
AS WELL AS H.I.V. SORRY, H.I.V.
R4P.
AND TWO VERY IMPORTANT STUDIES
WERE PRESENTED THAT WE WANTED
TO DRAW YOUR ATTENTION TO.
ONE, WAS THE PURPOSE ONE TRIAL
AND IT REALLY WAS A
BREAKTHROUGH STUDY THAT
DEMONSTRATED LENACAPAVIR WHICH
IS A CAPSID INHIBITOR, IS 100
PERCENT AFFECTIVE IN PREVENTING
H.I.V. TRANSMISSION AGAINST
TRANSGENDER WOMEN AND THAT WAS
GROUND BREAKING, IMPORTANT
FINDING THAT SORT OF MADE EVERY
ONE VERY EXCITED AND IT BUILDS
ON DECADES OF NIH SUPPORTED
BASIC SCIENCE.
THE DEVELOPMENT OF LENACAPAVIR
REALLY UNDER SCORES THE ROLE OF
H.I.V. INVESTMENTS IN
FUNDAMENTAL RESEARCH THAT CAN
LEAD TO THERAPIST AND
SIGNIFICANTLY REDUCE GLOBAL
H.I.V. CASES.
AT THE INTERNATIONAL SOCIETY'S
5th PREVENTION CONFERENCE OR
H.I.V. RAP, THE CONFERENCE
HIGHLIGHTED NEW DATA FROM THE
PURPOSE 2 TRIALS.
THE LARGE NATIONAL AIDS
CONFERENCE REPORTED ON PURPOSE
1, THIS ONE REPORTED ON PURPOSE
2, AND THIS HIGHLIGHTED TWICE
YEARLY LENACAPAVIR, TWO
INJECTIONS SIGNIFICANTLY
REDUCES, DEMONSTRATING 96
PERCENT ETHICACY AMONG A NUMBER
OF HIGH-RISK PO POPULATIONS.
SO THE ADVANCEMENT IS PART OF A
BROADER DISCUSSION AT THE EVENT.
AND IT HIGHLIGHTED INNOVATIONS
IN PREP DELIVERY METHODS,
H.I.V. VACCINE RESEARCH, LONG
ACTING ANTI RETRO TECHNOLOGIES
AND TO ME WHAT IS REALLY
IMPORTANT IS THE EMPHASIS ON
THE NEED FOR GLOBAL ACCESS TO
THESE TOOLS.
ESPECIALLY, IN REGIONS WHERE
H.I.V. ARE RISING LIKE LATIN
AMERICAN.
IT ALSO HIGHLIGHTS FOR ME
OPPORTUNITIES FOR
IMPLEMENTATION SCIENCE.
THAT NOW WE HAVE THESE TOOLS
THAT WORK AND WE NOW HAVE A
NUMBER OF TOOLS THAT WORK.
AND WHAT WE NEED TO UNDERSTAND
IS HOW WE'RE GOING TO GET THOSE
TOOLS INTO THE COMMUNITY THAT'S
MOST NEED THEM?
WHAT DO WE NEED TO DO?
CAN WE IMPROVE REACH?
HOW CAN WE IMPROVE UPDATES?
WE KNOW THAT THERE ARE BARRIERS
TO GETTING THESE TECHNOLOGIES
OR INNOVATIONS OUT THERE AND
THAT IS AN EXCITING PART OF
THIS JOB FOR ME SO THAT I CAN,
SO THAT WE AS A TEAM CAN THINK
ABOUT HOW TO DO THAT.
I THINK I'M SUPPOSE TO PIVOT
RIGHT NOW AND ALLOW--.
>> ACTUALLY DR. DO
NOT--DONENBERG, HE HAD TO EXIT
SO FEEL FREE TO CONTINUE.
>> WE HAVE FOLKS WHO ARE
ATTENDING THAT FROM OUR OFFICE.
THE 15th INTERNATIONAL WORKSHOP
ON HIV AND AGING.
AND THIS IS A PLATFORM FOR
INTERNATIONAL CROSS
DISCIPLINARY EXCHANGE ON
INCREASINGLY ENCOUNTER IN THE
CLINICAL CARE AND DESIGN OF
STUDIES TO IMPROVE THE CARE OF
PERSONS AGING WITH H.I.V.
THEY BRING TOGETHER RESEARCHERS
AND COMMUNITY ADVOCATE IN ORDER
TO FOSTER DIALOGUE AND PROMPT
DISILLUSIONS, MAINLY TO BENEFIT
THE AGING POPULATION LIVING
WITH H.I.V.
WE ALSO ORGANIZED A SYMPOSIUM
IN PARTNERSHIP WITH THE
NATIONAL INSTITUTE OF MENTAL
HEALTH FOR TRAINEES AND JUNIOR
SCHOLARS TO PRESENT THEIR
RESEARCH AND NETWORK AND LEARN
FROM OTHER EXPERTS IN THE FIELD.
COMING UP, WE ARE GOING TO BE
ATTENDING THE ANNUAL 28th
ANNUAL NATIONAL CENTERS FOR
AIDS RESEARCH OR THE C-FAR
MEETING AND THAT'S GOING TO BE
IN NEW YORK.
AND I'LL BE SPEAKING AT THE
MEETING AS PART OF THE LARGER
AS PART OF THE PANEL PROVIDING
NIH PERSPECTIVE AND I REALLY
HOPE TO SPEND SOME TIME
EMPHASIZING THE SPORTS OF
TREATMENT ACCESS UP TAKE,
ADOPTION AND SUSTAINABILITY.
AND FINALLY, I'M REALLY LOOKING
FORWARD TO ATTENDING THE 83rd
MEETING OR PATCHA IN DECEMBER
IN ALABAMA.
AND AUZ A REMINDER, PATCHA
PROVIDES ADVISE, INFORMATION
AND RECOMMENDATIONS TO THE
SECRETARY OF HEALTH AND HUMAN
SERVICES REGARDING PROGRAMS AND
RESEARCH TO PROMOTE AFFECTIVE
TREATMENT AND PREVENTION OF
CURE AND H.I.V. INCLUDING
COMORBIDITIES.
NEXT SLIDE, PLEASE.
I DO WANT TO CALL ATTENTION TO
WORLD AIDS DAY WHICH IS
HAPPENING ON DECEMBER 1st IS
THE ANNUAL OBSERVANCE ALTHOUGH
BECAUSE THAT FALLS ON A
WEEKEND, OUR OFFICE IS GOING TO
BE CELEBRATING IT ON DECEMBER 4.
AND NIH IS STEWARD OF THE WORLD
LARGEST SECTOR INVESTMENT IN
HIV RESEARCH, WE'LL CONVENE
ACROSS RESEARCH PARTNERS TO
DISCUSS, RESENT PROGRESS AND
CHALLENGES THAT REMAIN, SHARE
UPDATES ON THE CURRENT STATE OF
HIV AND AND WHAT IS TO COME AND
COLLABORATE EXTENSIVELY WITH
FEDERAL PARTNERS TO COORDINATE
EFFORTS.
SO THIS YEAR'S FEDERAL WORLD
AIDS DAY THEME IS COLLECTIVE
ACTIONS, SUSTAINED AND
ACCELERATE HIV PROGRESS.
THIS THEME REFLECTS THE U.S.
GOVERNMENT'S COMMITMENT TO
BUILD ON THE MAJOR ACHIEVEMENTS
OF GLOBAL AND DOMESTIC HIV
PROGRAMS OVER THE PAST FOUR
YEARS.
SORRY, THE PAST FOUR DECADES.
THIS WAY, I THINK THIS
PARTICULAR CELEBRATION REALLY
WILL STRIFE TO ENSURE THAT ALL
COMMUNITIES ARE INCLUDED IN IN
THE BENEFITS THAT WE HAVE
ACHIEVED.
AT THE SAME TIME, WE HAVE
FOCUSED ON INNOVATIVE AND
ADAPTING STRATEGIES BASED ON
THE BREAKTHROUGHS,
IMPLEMENTATION RESEARCH AND
INSIDE GAIN FROM ON THE GROUND
PROGRAMS.
THE OAR WORLD AIDS DAY EVENT
WILL OCCUR ON DECEMBER 4th, AS
I MENTIONED.
PLEASE VISIT OUR WEBSITE FOR
MORE INFORMATION AS IT BECOMES
AVAILABLE.
NEXT SLIDE, PLEASE.
WONDERFUL.
OKAY.
HHS, OFFICE OF INFECTIOUS
DISEASES IS IN THE PROCESS OF
DEVELOPING THE 2026 TO 2030
NATIONAL STRATEGIC PLANS FOR
EACH OF THESE AREAS YOU SEE IN
THE SLIDE.
SO YOU SEE FOR SEXUALLY
TRANSMITTED INFECTIONS, VACCINE
AND VIRAL HEPATITIS.
THEY'RE COLLABORATED WITH THE
WHITE HOUSE OF AIDS POLICY TO
DEVELOP THE 2026 TO 2030
NATIONAL AIDS HIV-AIDS STRATEGY.
TONE SURE THESE PLANS ARE
RELEVANT AND AFFECTIVE, THEY
HAVE PUT OUT A REQUEST FOR
INFORMATION AND THAT'S FOR ALL
OF YOU ON THIS CALL OR ANYONE
WHO IS INTERESTED TO SUBMIT
INFORMATION THAT YOU WOULD THAT
IN RESPONSE TO THIS CALL.
SO, THEY WOULD LIKE INPUT FROM
INDIVIDUALS ORGANIZATIONS AND
PUBLIC HEALTH PARTNERS ONLINE
WITH SUBMISSIONS ARE OPEN UNTIL
SEPTEMBER 6.
SO PLEASE CONSIDER USING THE QR
CODE ON THE SLIDE TO ACCESS THE
FORM AND SUBMIT FEEDBACK.
VIRTUAL LISTENING SESSIONS WILL
ALSO BE HELD TOGETHER FEEDBACK
AND OAR OFFICE HAS ALREADY
PROVIDED INPUT FOR THE 2024 TO
2030 STRATEGIC--NATIONAL H.I.V.
STRATEGIC STRATEGY.
NEXT SLIDE, PLEASE, OOPS.
SORRY.
ALL RIGHT, NOW I WOULD LIKE TO
DO A BIT OF AN UPDATE ON THE
STRATEGIC PLAN PROCESS BUT I
THINK YOU'RE GOING TO HEAR MORE
ABOUT THIS LATER.
BUT NEXT SLIDE, PLEASE.
WHAT YOU SEE HERE IS THE WHAT
THE PLAN IS AND WHAT THE PLAN
IS NOT.
AND I THINK IT'S IMPORTANT TO
HIGHLIGHT FOR YOU THAT YOU KNOW
THE NIH STRATEGIC PLAN FOR
H.I.V. AND HIV-RELATED RESEARCH
GUIDES THE LARGEST INVESTMENT
IN HIV RESEARCH AND BUILDS ON
SIGN CIENTIFIC PROGRESS AND
OPPORTUNITIES TO ADVANCE TO
REACH 'EM DEM --EPIDEMIC
CONTROL.
AND YOU'LL SEE ON THIS SLIDE
THE PLAN, AND WHAT IT'S NOT.
IT'S NOT A STATIC PLAN, IT'S
NOT GRANULAR OR ALL INCLUSIVE,
IT CAN'T STAND ALONE.
IT'S OVER ARCHING ROAD MAP FOR
THE GUIDING FRAMEWORK THAEN
SHOESER THAT THE FUNDS ARE
ALLOCATED IN ACCORDANCE WITH
THE ESTABLISHED NIH SCIENTIFIC
PRIORITIES.
YOU'LL ALSO NOTICE THAT THE
PLAN IS BROAD ENOUGH TO CAPTURE
EVERYTHING THAT COULD BE FUNDED
WITH H.I.V. DOLLARS WHILE ALSO
TRYING TO HIGHLIGHT SPECIFIC
AREAS THAT SHOULD BE
PRIORITIZED.
AND THEN, FINALLY THE PLAN IS
ALIGNED WITH NATIONAL NIH, HIV
STRATEGY AND PLAN THAT IS
REVIEWED ANNUALLY.
INPUT FROM A BROAD RANGE OF
INTERESTED PARTIES, THIS
INCLUDES RESEARCHERS,
HEALTHCARE PROFESSIONALS,
ADVOCATE, SCIENTIFIC AND
PROFESSIONAL ORGANIZATIONS AS
WELL AS GOVERNMENT AGENCIES AND
COMMUNITY MEMBERS.
AND THE PLAN WILL CONTINUE TO
EVOLVE TO REFLECT RESEARCH
ADVANCES AND CHANGES IN THE
NEEDS OF THOSE AFFECTED BY
H.I.V.
NEXT SLIDE PLEASE.
THIS SLIDE JUST PROVIDES A BIT
OF AN OVERVIEW OF THE PLAN
PROCESS THAT WE WANT TO
HIGHLIGHT FOR YOU.
THE FIRST IS THAT YOU CAN SEE
HERE, THAT LET'S GO TO THE
NEXT, THE NEXT SLIDE, THE FIRST
IS THAT WE RECEIVED IMPACT FROM
MANY INDIVIDUALS AS I NOTED,
PREVIOUSLY.
AND THEN OVER THE LAST YEAR
INTERNAL WORKING GROUP AT OAR
CORRELATED THE FEEDBACK AND THE
INPUT FROM ALL THE VARIOUS
CONSTITUENCIES.
AND IF YOU CAN GO TO THE NEXT
SLIDE.
SO THIS IS JUST TO SHOW YOU
WHERE ALL THE FEEDBACK AND THE
SOURCES OF ALL THE FEEDBACK AND
SOURCES THAT WENT INTO THE
STRATEGIC PLAN THAT YOU'LL HEAR
ABOUT IN A MOMENT.
BUT I THINK IT'S VERY IMPORTANT
TO SEE ALL THE DIFFERENT
MEMBERS WHO ARE REPRESENTED
HERE AS WELL AS THE DATA THAT
WERE USED TO STRENGTHEN AND
OPTIMIZE THE PLAN.
SO THERE WERE INTERNAL
RESOURCES, YOU CAN SEE ON THE
LEFT IN TERMS OF NIH AND OAR
AND NIAD, BUT ALSO WORKSHOPS
AND LISTENING SESSIONS.
AND THOSE ARE REFLECTED IN THE
BLUE WRECK TANGLES TO THE RIGHT
AND OF COURSE OARAC IS CRITICAL
AND YOU'LL SEE, OARAC STANDS AT
THE BOTTOM WITH AN ARROW INTO
THE STRATEGIC PLAN AND IT'S
ANOTHER FOUNDATIONAL SOURCE OF
INPUT AS SEEN ON THIS GRAPHIC.
NEXT SLIDE, PLEASE.
AND THEN THE NEXT STEP THAT WE
DID WAS TO IDENTIFY TASK FORCES.
AND THOSE THOSE TASK FORCES
WERE CONVENED TO ANALYZE THE
INFORMATION GATHERED BY THE
SOURCES SHOWN ON THE PREVIOUS
SLIDE TO RESULT IN A REVISED
FRAMEWORK.
AND THESE TASK FORCES REVIEWED
THE INPUT THEY DISCUSSED, THEY
DELIBERATE D AND THEY REFINED
THE INPUT.
AND THESE THREE ASK FORCES,
FOCUSED ON FUNCTIONAL AREAS OF
SCIENCE, BASIC BIOMEDICAL
CLINICAL RESEARCH, AND
IMPLEMENTATION RESEARCH AND
CLINICAL AND INTERVENTION
RESEARCH.
SO YOU CAN SEE HERE THE THREE
TASK FORCES.
TASK FORCE ONE LEAD BY LOUIE
MONTANER.
AND TASK FORCE NUMBER 2 LEAD
BIO MARCH AND AMBER WILSON.
AND TASK FORCE NUMBER 3.
AND WE'RE SO GRATEFUL TO THE
TASK FORCES FOR REALLY PUTTING
TOGETHER AND WORKING HARD TO
DEVELOP THE PLAN THAT THEY PUT
FORWARD.
THE TASK FORCES ARE SHORT-TERM,
MULTI DISCIPLINARY WORKING
GROUPS SO BEYOND THE LEADERS
THERE WERE OTHERS THAT JOINED
AND THEY REPRESENT A VERY BROAD
DIVERSITY OF SUBJECT MATTER
EXPERTISE AND SCIENCE AND
POLICY AS WELL AS LIVED
EXPERIENCE.
AND THEY TOGETHER, PROVIDED
RECOMMENDATIONS REGARDING THE
RESEARCH PRIORITIES FOR THE NEW
STRATEGIC PLANS.
AND AGAIN, THEIR DEDICATION AND
PASSION TO THIS PROCESS IS
GREATLY APPRECIATED.
AND WE'LL BE HEARING MORE ABOUT
THEIR WORK LATER IN OUR AGENDA.
NEXT SLIDE, PLEASE.
THANK YOU.
AND THAT BRINGS US TO WHERE WE
ARE TODAY WHICH IS WE ARE
BRINGING IT TO OARAC, YOU, AND
YOU ARE RECEIVING REPORT OUTS
FROM EACH OF THE TASK FORCES
DURING THIS MEETING AND
HOPEFULLY YOU'LL BE MAKING
ADDITIONAL RECOMMENDATIONS
BASED ON WHAT YOU HEAR TODAY.
THE NIH CENTERS WILL ALSO SEE
THE RECOMMENDATIONS AFTER
OARAC'S FEEDBACK AND THEN WE'LL
ALSO PROVIDE ADDITIONAL
FEEDBACK ON STRATEGIC PLAN,
DRAFT STRATEGIC PLAN.
AND THEN IN FEBRUARY WE'LL BE
PRESENTING A UPDATE ON THIS
AGAIN.
OKAY, SO THAT INCLUDES MY
DIRECTOR'S REPORT AND I
APPRECIATE YOUR ATTENTION AND
DR. TURBULL BACK TO YOU.
>> THANK YOU, DR.
DOAN--DONE--DONENBERG.
DR. WSUNDQUIST SAID HE HAD TO
LEAVE EARLY?
SHOULD WE SHIFT?
>> I THINK IF WE COULD TAKE ONE
OR TWO QUICK COMMENTS OR
QUESTIONS, AND THEN LEAVE MORE
DISCUSSION FOR AFTER DR.
WSUNDQUIST IS FINISHED SO WE
CAN KEEP ON TRACK WITH HIS
AGENDA.
THANKS.
>> OKAY, GREAT, ARE THERE ANY
ONE OR TWO COMMENTS OR
QUESTIONS FOR DR. DONEBERG.
THANK YOU FOR SUCH A GREAT
REPORT.
>> WE'LL HAVE PLENTY OF TIME
LATER THIS AFTERNOON WHEN WE'RE
DISCUSSING THE STRATEGIC TASK
FORCE RECOMMENDATIONS, SO, WE
CAN PIVOT TO FINZI NOW.
>> DR. FINZI, YOU'RE GOING TO
INTRODUCE YOUR GUEST.
YOU MAY PROCEED.
>> OKAY, I HAD JUST A COUPLE OF
SLIDES.
I WAS WONDERING IF YOU HAVE
THEM.
OKAY, GREAT.
SO YOU KNOW, IT'S FUNNY, I, I'M
SO HAPPY TO HAVE WES HERE
TODAY, BECAUSE I FEEL LIKE THE
LENACAPAVIR STORY, YOU GO AND
HEAR ABOUT HOW GREAT THIS DRUG
IS AND WHAT AMAZING STRIDES
WE'VE MADE.
BUT THE STORY, THE LENACAPAVIR
STORY DOES NOT START WITH A
PURPOSE TRIAL, IT STARTS MUCH
BEFORE THEN.
AND JUST TO HIGHLIGHT A LITTLE
BIT, THE NIH, I WOULD LIKE TO
SAY THAT IT BEGINS WITH THE NIH
COMMITMENT AND INVESTMENT AIMED
AT UNDERING THE BASIC MECHANISM
THAT'S HIV USES TO INFECT CELLS.
SO NIH STUDIES IN THELE 80s AND
90s EARLY ON AND REVEALED
TARGETS, LIKE REVERSE
TRANSCRIPTAS AND AND THIS WAS
CRITICAL IN AIDING THE
DEVELOPMENT OF ANTI VIRAL DRUGS
THAT WE'RE USING THROUGHOUT THE
WORLD TODAY.
AND CONTINUED NIH SUPPORT
INCLUDING THE SUPPORT OF THE
CENTERS OF STRUCTURAL BIOLOGY
AND IN THE 2000 ENABLED SIGN
TIFFS TO INTEGRATE, TO CAPTURE
THE THREE DIMENSIONAL
STRUCTURES OF H.I.V. PROTEINS
AND THEIR INTERAGENCIES WITH
CELLULAR COMPONENTS IN
UNPRECEDENTED DETAIL.
IV PROTEINS AND THEIR
INTERAGENCIES WITH CELLULAR
COMPONENTS IN UNPRECEDENTED
DETAIL.
BUT THE CAPSID PROTEINS RANGE
THEMSELVES INTO REGULAR SHAPES
AND PENTMERS THAT COME TOGETHER
IN SORT OF A SOCCER BALL
ARRANGEMENT THAT IS CALLED THE
CONE.
AND LENACAPAVIR LINES WITHIN A
POCKET WITHIN THIS CAPSID LATIS
AT VARIOUS POINTS IN THE HIV
LIFECYCLE.
SO IN OTHER WORDS, THIS CONE
STRUCTURE TURNED OUT TO BE A
GREAT WITH THIS DRUG AND WITH
THE VULNERABILITIES WHICH
YOU'LL HEAR MORE ABOUT TODAY.
WES AND OTHER COLLEAGUES
COLLABORATE WITHED GIL IAED AND
HELPED DEVELOP LENACAPAVIR.
AND THEN GIDIAED INSUPPORTED
AND NOW NIH SCIENTIST ARE DOING
RESEARCH TO UNDERSTAND HOW
RESISTANCE ARISES AND HOW TO
MONITOR THE ETHICACY OF THE
DRUG IN THE CLINIC.
IN TURN, LENACAPAVIR IS TELLING
US MORE AND MORE ABOUT THE
CAPSID STRUCTURE HOW IT
FUNCTIONS DURING INFECTIONS AS
A FULL CIRCLE IN THE CYCLE OF
SCIENCE.
SO NOW, IT IS REALLY MY GREAT
PLEASURE TO INTRODUCE DR.
WESLEY WSUNDQUIST WHO WILL
SPEAK MORE ABOUT THE REMARKABLE
NIH SUPPORTED BASIC SCIENCE
THAT LEAD TO THIS GREAT
BREAKTHROUGH.
DR. WSUNDQUIST IS THE
PRESIDENTIAL HAIR CHAIR,
DISTINGUISHED PROFESSOR AND
CHAIR OF THE BIOCHEMISTRY AT
THE UNIVERSITY OF UTAH.
DR. WSUNDQUIST XLAOED HZ Ph.d
IN CHEMISTRY FROM MIT, WORKING
WITH STEVEN J AND WAS A NATO
POST DOCTORAL AT THE MIC
LABORATORY OF MALECULAR BIOLOGY
ELECTED TO THE NATIONAL ACADEMY
OF SCIENCES AND RECEIVED JUST
THIS PAST YEAR IN 2024, THE
HORWITS PRIZE FOR RESEARCH AND
BIOMEDICAL SCIENCE WITH DR.
SCOTT 'EMER, WES, REALLY A
PLEASURE TO HAVE YOU.
>> THANK YOU, DIANA FOR THAT
GENEROUS INTRODUCTION.
PEOPLE CAN SEE IN HERE OKAY?
>> YES.
>> THANK YOU, SO IT'S AN HONOR
TO ADDRESS THIS COMMITTEE.
AND AS YOU HEARD, THERE IS A
BREAKTHROUGH WITH LENACAPAVIR
AND CAP TOURS THE CAPSID
PROTEIN.
SO DIANA ASKED ME TO GIVE YOU A
BACKGROUND THAT SET THE STAGE
FOR LENACAPAVIR, SO THAT'S THE
GOAL OF WHAT I'M GOING TO DO
TODAY.
SO I THOUGHT I WOULD START WITH
THE PUNCH LINE, SO AS YOU ALL
KNOW, 1.3 MILLION PEOPLE WERE
NEWLY INFECTED WITH HIV AND
THAT HIGHLIGHTS THE DEVELOPING
THE PREVENTION LIKE VACCINE OR
AN EFFECTIVE APPLICATION.
AND THIS IS A SLIDE THAT I GOT
FROM TOMAS WHO IS OUR MAJOR
CONTACT AT GILAD AND HIGHLIGHTS
THE EXPERIMENT AT THE TRIAL.
SO WHAT YOU'RE LOOKING AT THIS
IS A CIS GENDER WOMEN, AS YOU
HEARD THE PURPOSE 2 IS SIMILAR
IN MALES AND NON BINARY
INDIVIDUALS AND THE RESULTS ARE
THE SAME IN BOTH.
AND THAT'S IF YOU LOOK AT THE
INCIDENT OF INFECTION.
IN AFRICA IT'S ABOUT 2.5 HER
100 PERSON.
IF YOU LOOK AT THE REGISTER
MINUTE, AT THIS IS AND IF YOU
LOOK AT THE CLINICAL RESULT FOR
LENACAPAVIR THE DRAMATIC
RESULTS IS THERE WERE NO
INFECTIONS.
SO THE INDEPENDENT GROUP
STOPPED THE CLINICAL TRIAL THIS
HAPPENED FOR PURPOSE 2 AND MADE
LENACAPAVIR AVAILABLE TO EVERY
ONE.
SO THESE RESULTS TOGETHER WITH
THE FACT THAT GILAD ANNOUNCED
THAT THEY'RE GOING TO ALLOW
GENERICS FOR THE POOREST OF 100
COUNTRIES IN THE WORLD, REALLY
RAISE THE PROMISE THAT THIS IS
GOING TO BEND THE PROGRESSIVE
OF HIV EPIDEMIC.
I WANT TO 'EM EMPHASIZE THAT
THE DRUG WAS DEVELOPED IN
GILIAD BUT CAPSID RESEARCHERS
IN SAYING THAT FIRST OF ALL
WE'RE REALLY EXCITED ABOUT THE
PROMISE, BUT SECOND OF ALL,
WE'RE PRIDE OF OUR
CONTRIBUTIONS THAT HELP TO MAKE
IT POSSIBLE TO DEVELOP FOR
GIDIAD FOR LENACAPAVIR.
AND THIS IS THE FIRST TIME THAT
WE'VE SEEN 100 PERCENT
PROTECTION FOR A PREP TRIAL.
SO IF WE'RE GOING TO TALK ABOUT
THE CAPSID, WE HAVE TO TALK
ABOUT WHERE IT CAME FROM.
AS YOU KNOW HIV IS A RETRO
VIRUS AND HAS A SINGLE GENE
THAT ORGANIZES THE VIRAL
PARTICLE.
SO GAG FIRST GETS MADE AS A
POLY PEPTIDE WHICH HAS A SERIES
OF SERIOUS REGION THAT THE
VIRUS USE TO SEE PERFORM
VARIOUS FUNCTIONS AND IT BINDS
TO MEMBRANES AND HOW THE VIRUS
KNOWS TO BIND TO THE MEMBRANE.
THE CENTRAL C A REGION TAKES
IMPORTANT PROTEIN PROTEIN
INTERACTIONS AT THIS STAGE AND
IT CUTS ON EITHER END OF THE C
A PROTEIN TO MAKE A NEW
DISCREET PROTEIN AND I'LL TRY
TO CALL C A, WE TRY TO CALL
THIS CA.
THE CA PROTEIN BUILDS THIS
CAPSID AND INSIDE THE CAPSID IS
THE VIRAL RNA AND WE TRY TO
CALL THIS ENTIRE CAPSID THE
CORE.
THEN THE NC IS A BINDING
PROTEIN, IT CAPTURES THE
GENEOWED AND WE THINK IT COATS.
AND P6 IS A REGION OF THE
PROTEIN THAT RECRUITS PROTEIN
AND THAT ALLOWS THE VIRUS TO
PINCH OFF CELLS AND TO SPREAD
AN INFECTION.
SO THE POINT I WANT TO MAKE
HERE IS THAT WE THINK OF THE
IMMATURE PARTICLE BEFORE GAG
HAS BEEN COLLEAGUED AS ASSEMBLY.
AND WHAT PROTO AL SIS DOES IT
CONVERTS THE ASSEMBLY MACHINE
INTO A INFECTIOUS PARTICLE AND
WE THINK OF THAT AS A PARTICLE
THAT IS ABLE TO ENTER AND
REPLICATE IN A NEW HOST CELL.
SO THAT'S THE PURPOSE OF THIS
TRANSFORMATION.
SO I'M EXCITE TODAY HAVE A
COLLEAGUE JANET THAT IS PART OF
AND SHE IS A MASTER MELACULR,
IT GOES THROUGH MELACLUR I'M
GOING TO SHOW YOU HER ANIMATION.
THESE ARE THE SPIKE PROTEINS,
THESE ARE THE GAG PROTEIN AND
SOMETIMES GAG IS MADE AS A
LONGER PROTEIN THAT'S HOW THE
ENZYMES GET INTO THE PROTEINS.
AND IF I RUN THE VAO, YOU SEE
THAT THEY ORGANIZE THEMSELVES
UNDER THE MEMBRANE OF INFECTED
CELL.
WE THINK VIRUS USES HELP FROM
HOST PROTEIN TO BEND THE
MEMBRANE AND WHEN IT REACHES
THE WHAT WE CALL THE LOLLIPOP
IT SEVERALS THE NECK AND
RELEASE THE VIRUS PARTICLE.
SO VIRUS IS RELEASED AS A
IMMATURE IT CUTS GAG AND GAG
PAUL INTO SMALLER PIECES.
THE NC AND RNA CONDENSED TO THE
CENTER OF THE VIRUS, AND THE CA
PROTEIN BUILDS THIS CHRONICLE
CAPSID THAT SOUNDS THE GENO.
SO THE THE REST OF THE TALK
WORE GOING TO TALK ABOUT THIS.
: SO ONE OF THE THINGS I WANT
TO EMPHASIZE THIS IS THAT WE'VE
BEEN DOING THIS FOR SOMETIME.
AND AS GERRY SAID, BASIC
RESEARCH, ALMOST FULFILLS
IMPORTANT PROMISES BUT IT TAKES
SOMETIME.
AND SO WHEN WE STARTED OUR WORK
IN THE 1990s, WE THOUGHT THE
MOST IMPORTANT THING TO
UNDERSTAND FIRST WAS WHAT IS
THE STRUCTURE OF THE PROTEIN?
BECAUSE WE BELIEVE THE
STRUCTURE OF PROTEIN DICTATES
ITS FUNCTION SO. TOGETHER WITH
MIKE SUMMERS AND CHRIS HILLS,
WE WERE ABLE TO SHOW THAT THE
PROTEIN FORMS A DAIMLER, IT
COMES TOGETHER AS TWO COPIES
AND DETERMINE THE STRUCTURE OF
THE DAIMLER.
SO THE C TERMINAL DOMAIN, WE
THOUGHT OF PROTEIN OF LOOKING
LIKE THE HEAD OF A RABBIT.
SO TWO COPIES OF THE C TERMINAL
DOMAIN COME TOGETHER SO THAT
MAKES THE DAIMLER AND THEN THE
EARS OF THE RABBIT ARE DEFINED
BY THE END TERMINAL DOMAIN OF
THE C A PROTEIN.
SO THAT WAS A GOOD START BUT TO
GIVE YOU A SENSE OF SCALE, IT
TAKES ABOUT 750 COPIES OF THIS
DIME TORE MAKE THE DOM NAL
CAPSID.
SO WHAT WE HAD TO UNDERSTAND IS
HOW DOES THE CA PROTEIN BUILD A
CONE?
AND WE HAD A VERY TALENTED
GRADUATE STUDENT AND SHE WAS
WORK WITHING PURE PROTEIN IN
THE LAB.
AND ONE DAY SHE STUMBLED ON
CONDITIONS ON THE CA PROTEIN
WOULD SPONTANEOUSLY FORM THESE
CAPSIDS.
IT'S MAKING CONES, SO INS THE
PROTEIN AND IT'S MAKING ZONES.
AND THIS IS AN ELECTRON MICRO
GRAPH ON FILM.
SO MY CONTRIBUTION TO THIS
EXPERIMENT WAS TO PUT MY THUMB
PRINT ON THE NICEST CONES THAT
WE HAD IN THE LAB.
AND WHEN YOU LOOK AT THE
STRUCTURES THEY CAN LOOK
SIMILAR TO THE CAPSID, SO THESE
ARE THIN SECTION IMAGES, SO
THIS IS THE ACTUAL VIRUS, YOU
CAN SEE THE CON:CA RID.
THIS IS THE STRUCTURE THAT
BARBIE WAS MAKING WITH PURE
PROTEIN AND YOU CAN SEE IT'S
THE SAME SCALE AND SIZE AND HAS
THE SAME CONE ANGLE.
AND IMPORTANTLY, IT LOOKS LIKE
IT'S CLOSED AT BOTH ENDS.
SO AT THAT POINT, WE HAD TO
THINK ABOUT HOW A SINGLE
PROTEIN SPONTANEOUS LEA SEMBLE
INTO A CONE.
SO THE CONE IS A UNUSUAL
ASSEMBLY IN BIOLOGY, AS FAR AS
WE'RE AWARE, THIS IS THE ONLY
EXAMPLE OF CANONICAL ASSEMBLY
AND BIOLOGY.
AND AT THE SAME TIME, SAM LEE
WORKING WITH FINCH, ONLY
STUDENT IN THE LAB WAS ABLE TO
SHOW THAT NOT ONLY DID THE
PROTEIN FORM DIMERS BUT IT
COULD ALSO FORM HEX AMERI RIGS.
SO WHEN WE PUT THAT INFORMATION
TOGETHER, WHICH IS THE DIA NA
WHAT WE CALL A FULLER EVEN ZONE.
SO THE SO THE BODY OF THE CONE
IS COMPOSED OF THESE SIX MEMBER
RINGS.
SO THIS IS LUKE A SOCCER BALLS.
AND THAT TURNS OUT TO BE
UNIVERSALLY TRUE, IT CAN'T
CLOSE UNLESS YOU PUT 12
PENTMERS SO THE VIRUS PUTS 7
PENTMER AT THE WIDENED AND 5 AT
THE NARROW END AND THAT FORMS A
CAPSID.
SO THE NEXT REALLY IMPORTANT
BREAKTHROUGH WAS MADE BY OWEN,
THEY WERE ABLE TO CLEVERLY
STABILIZE THE HEXMER AND
PENDMER AND EXTRACT THEM FROM
THE STRUCTURES THAT I SHOWED
YOU AND THAT ALLOWED THEM TO
CRYSTALIZE THE HEXMER AND
PENTMER AND THAT WAS IMPORTANT
ADVANCE FOR THREE REASONS.
ONE, IT PROOFS THAT THERE WERE
HEXMERS AND PENTMERS SO THAT
WAS STRONG EVIDENCE IN THE CONE
MODEL THAT I JUST SHOWED YOU.
THE SECOND IMPORTANT
CONTRIBUTION, WAS THAT IT IT
SHOWED US THE ATOMIC STRUCTURE.
AND FOR THOSE OF YOU WHO FOLLOW
VIRUS ASSEMBLY THESE TWO ARE
RELATED BY WHAT CASPER AND MY
FORMER POST MASTER CALLED
EQUIVALENTS.
THEY LOOK SIMILAR YOU CAN
REMOVE THE SUB UNIT AND CLOSE
OUT THE RING AND YOU GET THE
PENTMER.
AND THE FINAL IMPORTANT
CONTRIBUTION, THIS REPRESENTED,
IT ALLOWED STRUCTURE DESIGN.
YOU CAN BIND INHIBITOR SXZ SEE
EXACTLY HOW THEY BOUND AND
THAT WAS KEY IN MAKING
LENACAPAVIR THE PRECURSORS
BETTER AND BETTER.
SO IT TURNS OUT TO UNDERSTAND
WHEN LENACAPAVIR IT'S IMPORTANT
TO UNDERSTAND HOW THE HEXMER
PACK WITH ONE ANOTHER.
SO THIS IS HEXMER AS YOU WOULD
SEE IN THE BODY OF THE CONE AND
IT PACKS WITH SIX NEAREST
NEIGHBORS.
SO THIS IS HEXMER PACKED
AGAINST THIS HEXMER AND YOU CAN
SEE THE SEA TERMINAL DOMAIN NZ
LIGHT GREEN FROM ONE HEXMER AND
THE LIGHT RED AND THE ANOTHER
ALL OF THESE TWO HEXMER
TOGETHER.
AND IF WE EXTRACT THAT THAT'S
WHAT THIS LOOKS LIKE AND IF WE
TURN IT ON ITS SIDE, THAT'S THE
HEAD OF THE RABBIT SO. THAT
EXPLAINED HOW AS YOU RAISE THE
PROTEIN CONCENTRATION, YOU
FIRST FORMED DIMERS BUT THEN
THE DIMERS FORMED HEXMERS WHICH
CAN FORM THIS LATIS.
LATTICE.
A LOT OF GROUPS CONTRIBUTED I
WILL NOT NAME THEM ALL BUT I
WILL MAKE IT CLEAR THAT THERE
WERE A LOT OF CONTRIBUTORS
IMPORTANT WAS CHANG AND ANGELA
AND CHRIS AIKENS AND THEIR
COLLEAGUES AND THEY EMPHASISED
THAT ANOTHER INTERACTION THAT
HOLDS THE LAT --LATTICE
TOGETHER IS THIS THREE
INTERACTION AND THAT'S
IMPORTANT FOR MAKING THE
LATTICE.
AND THEN, MAYBE THE MOST
IMPORTANT INTERACTION OF ALL,
IS AN INTERACTION THAT
STABLELIZED THE HEXMER SO. THIS
RED SUB AOUPT THE SEA TERMINAL
DOMAIN PACKS AGAINST THE DOMAIN
OF ITS NEAREST NEIGHBOR WITHIN
THE HEXMER SO THE SEA TERMINAL
SORT OF BUT THE--BUTRESS, IT
CREATES THIS LARGE CREVICE AND
IT'S A CONSERVE HYDRO PHOBIC
CREVICE AND THE VIRUS USES THAT
CREVICE TO BIND AND HOST
PROTEINS.
THIS IS ONE EXAMPLE OF CPSF6 SO
THE VIRUS NEEDS THESE TO GET
INTO THE NUCLEUS SO IT
CONSERVES THEM.
AND I'LL COME BACK TO THAT IN
JUST A MOMENT SO. JUST TO
FINISH THE UNDERING OF THE
ARCHITECTURE OF CAPSID, ONE OF
THE THINGS THAT I WANT TO
EMPHASIS IS HIV HAS BEEN A
AMAZING TESTING GROUND FOR NEW
TECHNOLOGY THIS WAS TM
TOPOGRAPHY, THEY'RE ACTUALLY
LOOKING AUTHENTIC VIRUS AND USE
EM BUT IN THREE DIMENSIONS AND
WHAT YOU CAN SEE, SO WE'RE
SLABING THROUGH FOUR VIRAL
PARTICLES, YOU CAN SORT OF MAKE
OUT THE CONE.
AND THEY HAVE SUFFICIENT
RESOLUTION THAT IF WE RENDER
THOSE CONES YOU CAN SEE THAT
THE CONES IN THE CENTER OF THE
VIRUS ARE IN FACT FULLER' CONES.
SO YOU CAN SEE THAT THERE IS A
BODY, THERE ARE FIVE PENTMERS
AND IT LOOKS LIKE WHAT WE
ANTICIPATED.
BUT WHAT IS INTERESTING IF YOU
LOOK AT THE STRUCTURES, YOU CAN
SEE THAT THEY ALL LOOK SLIGHTLY
DIFFERENT, HERE, THE PENTMERS
ARE MOVED OUT INTO THE HEX SO
IT'S A STUBIER STRUCTUREMENT
AND HERE THE VIRUS HAS PUT SIX
PENTMERS ON ONE SIDE AND THE
OTHER.
IT'S A HEXAGONAL HEELCAL
LATTICE.
I HOPE YOU AGREE THOSE ARE
BEAUTIFUL STRUCTURE AND I'M NOT
THE ONLY PERSON THAT THINKS
THA. I WAS SITTING AT MY DESK
AND SOMEBODY CALLED, IT WAS A
GUY THAT BUILT COMPUTER VIRUS.
WHAT HE MEANT WAS SOMETHING
DIFFERENT, SO HE TAKES APART
OLD COMPUTERS AND SCAVENGES THE
PARTS AND MIRRORS FROM NEW
COMPUTERS AND REBUILDS THEM
INTO SCULPTURE AND THIS IS HIS
SCULPTURE, THIS IS A HIV CONE
IT'S LIKE A DISCO BALL.
AND HE'S NOT THE ONLY PERSON,
THIS IS HIGHLIGHTING ANOTHER
ARTIST CALLED JOHN WALTER WHO
IS A MULTI MEDIA ARTIST.
HE HAD A TRAVELING SHOW A FEW
YEARS AGO, IT'S CALLED CAPSID,
THIS IS A PICTURE FROM THE SHOW
IN THE GALLERY IN LONDON.
THIS IS JOHN, AND IT'S A MULTI
MEDIA MULTI LARGE SHOW BUT YOU
CAN SEE THE BIGGEST SINGLE
PIECE IS THIS ROUGHLY 15-FOOT
BY 20-FOOT CENTRAL PIECE AND AT
THE CENTER IS THE HIV CAPSID.
IT'S CAPTURED THE IMAGINATION
OF PEOPLE BECAUSE IT'S A
STRUCTURE IT HAS NO SYMMETRY,
IT'S A CONE SO IT LACKS
SYMMETRY AND ALSO BECAUSE IT
REPRESENTS BOTH A HUGE AMOUNT
OF HUMAN SUFFERING BUT ALSO
ULTIMATELY, THE CURE TO VIRUS.
WHAT IS IT GOOD FOR?
AND THIS SLIDE HIGHLIGHTS AN
EXPERIMENT THAT WAS DONE BY A
POST DOC AND I WANT TO
EMPHASIZE THE FIELD HAS MADE A
LOT OF CONTRIBUTIONS.
WHAT UTA DID, I TOLD YOU WE
KNEW THE STRUCTURE SO SHE COULD
DESIGN SINGLE MUTATION THAT'S
WERE DESIGNED TO ALTER THE
SURFACE OF THE CAPSID SLIGHTLY
BUT WITHOUT ALTERING THE
STRUCTURE.
AND SHE MEASURED THE INFECTITY
AND TO OUR SURPRISE, THEY BUILT
IN THIS CASE, 50 POINT
MUTATIONS AND 46 OF THEM WERE
AT LEAST TWO-FOLD IN
INFECTIVITY.
SO WITH WHAT THAT SAID WAS EVEN
SMALL SURFACES HAVE DETRIMENTAL
AFFECTS ON VIRAL REPLICATION.
SO HER MUTUAL, HER SET OF
COLLECTION OF MUTANTS ARE
IMPORTANT BECAUSE THEY HELP
SEPARATE OUT THE FUFRPTIONS OF
THE PROTEIN.
SOY TOLD YOU THAT THE CA
PROTEIN IS PART OF MAKING THE
IMMATURE VARIANT AND THESE RED
BALLS ARE MUTATIONS THAT REDUCE
VIRUS PROTECTION.
THE GREEN AND BLUE ONE ARE MORE
INTERESTS THEY MAKE CAPSIDS AND
IN THE BLUE ONE IS COMPLETELY
NON INFECTIOUS.
SO THAT TOLD US THAT THAT HAS
TO PERFORM IMPORTANT FUNCTIONS.
WITH CHRIS AIKENS LAB, WE WERE
ABLE TO SHOW THAT A COUPLE OF
MUTATIONS WERE MAKING THE CA
SID MORE STABLE THAN THE WILD
TYPE CAPSID AND THEY WERE
POORLY INFECTIOUS SO THIS SET
UP THIS SORT OF GOLDIE LOX
SITUATION.
AND THIS THEN THIS YELLOW
MUTATION HZ NO, MADE NO CAPSIDS
AND THEY WERE ALWAYS NON
INFECTIOUS.
AND THEN WE KNEW AT THE TIME
ABOUT ONE POST PROTEIN, AND NOT
SURPRISINGLY ARE MUTATIONS
THERE INHIBITED THAT THE
BINDING OF THAT AND THAT ALSO
REDUCED VIRAL REPLICATION.
SO THE TAKE HOME MESSAGE HERE
IS THAT CA PROTEIN DOES A LOT
OF DIFFERENT THINGS AND THAT
IT'S VERY SENSITIVE TO ANY
PABTRABATION.
THIS IS A ILLUSTRATION BY JANET
OF THAT FIRST LIFECYCLE.
THIS IS THE INFECTIOUS VIRUS,
WITH PROTEINS THEY INTERACT
WITH THE CD4 AND COINACCEPTER
THAT CAUSES FUSION OF THE VIRAL
AND RELEASES THE CORE PARTICLE
IN THE CYTO PLASM.
THEY CAN DEVELOPED RESPONSE
THAT'S CAN RECOGNIZE THE CORE
AND INACTIVATE IT.
BUT IF THE VIRUS ESCAPES THOSE
SYSTEMS, THEN MOSES HERE ON THE
COUNCIL HAS SHOWN THAT THEY CAN
LATCH ON AND MOVE TO MICRO
TUBIALS TO THE NUCLEAR CORE.
AND I SHOULD SAY THAT ONE OF
THE THING THAT HIV RESEARCH HAS
BEEN USEFUL AND AS DIANA SAID,
THERE ARE OFTEN THESE FULL
CYCLES IS TO HELP TO INFORM
CELL BIOLOGY.
SO IT WAS THOUGHT THAT THE CORE
PARTICLE COULDN'T GET INTO THE
NUCLEUS AND THAT'S BECAUSE
THEIR CELL BIOLOGY COLLEAGUES
HAD UNDERESTIMATED THE SIZE OF
THE POUR.
BUT IN FACT, GROUPS SHOW THAT
THE CORE DOES GET INTO THE
NUCLEI, AND IT TURNS OUT THAT
IT MAKES SENSE.
SO DURING ALL OF THESE STEPS,
THE MOST FAMOUS STEP IN VITRO
VILLOLOGY IS HAPPENING.
AND AT SOME POINT, AND WE DON'T
UNDERSTAND THIS WELL YET, THE
DNA HAS TO ESCAPE FROM THE
CAPSID AND DNA TOGETHER WITH
THE INTEGRATE ENZYME TO
INTEGRATES INTO THE CRONE ZONE.
--CHROMOSOME.
AND THIS IS WHY IT'S SO HARD TO
TREAT BECAUSE EVERY TIME
SOMEBODY GETS INFECTED, THERE
IS A REPLICATION--FIRST LINE
THERAPY I CAN AS IT COULD BE IF
WE CAN FIND OTHER DRUGS TO PAIR
IT WITH.
SO I THINK THERE IS A VERY
IMPORTANT ROLE STILL FOR
DISCOVERING HOW STEPS LIKE THIS
WORK SO THAT WE CAN UNDERSTAND
NEW DRUG TARGETS THAT MIGHT
GIVE RISE TO DRUGS THAT WOULD
PAIR WELL WITH LENACAPAVIR AND
OUR OTHER DRUGS.
SO I WANT TO TURN MIA --MY
ATTENTION TO HOW LENACAPAVIR
WORKS.
HE SAID DO YOU THINK CAPSID
WOULD BE A GOOD TARGET SO. WHEN
PHARMACEUTICAL COMPANY ASKED
THAT QUESTION, YOU SAY YES.
BUT I DID THINK THERE WAS
POTENTIAL BECAUSE OF SINGLE
MUTATIONS ON THE SURFACE ALWAYS
LEAD TO LESS INFECTIOUS VIRUS.
SO I WAS A SULT ANT, THIS IS
ANOTHER SLIDE THAT I GOT FROM
TOMAS, THEY'VE BEEN GREAT ABOUT
ACKNOWLEDGING THE CONTRIBUTIONS
OF THE COMMUNITY.
AND THEY STARTED STEVEN YEN
STARTED THEIR SCREENING PROGRAM
TO LOOK FOR SMALL MOLECULES
THAT WOULD ALTER CAPSID CA
INVIDRO.
SO AS I SHOW YOU, IT WILL
SPONTANEOUSLY,--AND IT START
INSIDE 2006 AND THEN DECIDED
THAT THEIR LEAD COMPOUND WAS
NOT GOING TO BE A DRUG.
SO AT THAT POINT, THEY
RESTARTED ANOTHER PROGRAM WITH
A SECOND LEAD, I'LL MENTION
THAT IN A MOMENT.
AND THEN I THINK REALLY
HEROICKLY, JOHN LINK LEAD THIS
MEDICINAL CHEMISTRY EFFORT
GOING FROM A LEAD COMPOUND TO
GOING TO LENACAPAVIR.
AND THE LEAD COMPOUNDS WERE
INTERESTING BECAUSE THEY
ACTUALLY PROMOTED ASSEMBLY
RATHER THAN BLOCKING IT.
THIS IS THE CHART OF MORE THAN
4,000 COMPOUNDED THAT GILET
MADE.
YOU CAN SEE THAT OVER SIX
YEARS, THEY END UP WITH
COMPOUNDS THAT ARE SIX LOGS
MORE POTENT.
AND I WOULD EMPHASIZE THAT EVEN
AT THESE STAGES, THEY WERE
HELPED BY BASIC SCIENCE.
SO DURING THIS PERIOD OF TIME,
THE STRUCTURE OF PENTMER AND
HEXMER AND PFIZER ALSO CAME OUT
WITH A MOLECULE CALLED C864
THAT SERVED AS A PROOF OF
PRINCIPLE SO EVEN THOUGH IT WAS
IMPORTANT.
IT HAS A POLY PEPTIDE BACKBONE
IT HAS A LARGE NUMBER OF
MODIFICATIONS AND IT BINDS WITH
PICAMO OR AFFINITY.
SO I WOULD LIKE TO TAKE YOU
THROUGH A PROPERTIES THAT MAKE
LENACAPAVIR SO SPECIAL.
SO GELIA HAS SHOWN THAT IT
BINDS TO THE POCKET.
YOU CAN GET DRUG RESISTANCE IN
CULTURE AND THAT OCCURS AT ALL
OF THESE AMINO ACIDS ZONE.
BUT WHEN THE VIRUS MAKES THE
MUTATION TZ GIVES RISE TO
POORLY REPLICATED VIRUS.
AND THEY'RE FINDING IT HAS TO
BE CONSERVED OR THE VIRUS IS
UNHAPPY.
THESE PROTEIN HELP THE VIRUS TO
GET INTO THE NUCLEUS.
SO THE SECOND PROPERTY OF
LENACAPAVIR IS ITS REMARKABLE
POTENCY.
THIS IS THE PLOT OF POTENCY SO
LOWER IS BETTER.
THIS IS LENACAPAVIR GS-CA 1.
AND YOU CAN SEE IT'S ABOUT A
ORDER OF MAGNITUDE AND THEY
ALSO WORK AGAINST OR THE
CLASSICAL DRUGS AND THEY ALSO
WORK AGAINST ALL THE DIFFERENT
SUB TYPES AS YOU WOULD EXPECT
BECAUSE THIS IS A CONSERVED
POCKET.
BUT REALLY THE MOST REMARKABLE
PROPERTY OF THE DRUG IS THAT
ITS LONG LASTING CONNECTIVES.
SO THIS IS FROM THE PHASE ONE
TRIALS, THEY INJECT PEOPLE WITH
THE DRUG, DIFFERENT LEVELS OF
THE DRUG AND THEN MEASURE THE
LEVELS OF THE DRUG IN THE BLOOD
AS A FUNCTION OF TIME AND THIS
RED LINE SHOWS THE EC95 THAT'S
THE DRUG LEVEL THAT WOULD BE
EXPECT TODAY INHIBIT 95 PERCENT
OF THE VIRUS.
AND YOU WOULD EXPECT AS IT
SLOWLY DECAYSED BUT THE KEY
THING IS THAT IT'S VERY SLOW.
SO THIS IS 24 WEEKS, THESE
WELL-TOLERATED LEVELS ARE STILL
ABOVE THE EC95.
SO THE DRUG WAS APPROVED FOR
INFECTED THERAPIES TWO YEARS
AGO FOR SIX-MONTH THERAPIES.
SO MAYBE, I'LL FINISH THE
SCIENCE PART BY TELLING YOU
THAT WE'RE STILL VERY EXCITED
ABOUT CAPSID RESEARCH, ONE OF
THE BREAKTHROUGH THAT'S WE HAVE
MADE TOGETHER WITH OWEN LAB WE
CAN NOW PURIFY CAPSID AND MAKE
THEM HOMOGENEOUS PURE, WE DON'T
HAVE TO LOOK AT LOOK AT ONE
VIRUS INFECTING A SINGLE CELL.
AND I HAVE TO SAY THAT THE
FIELD IS VERY ACTIVE, MAKING
REALLY IMPORTANT CONTRIBUTIONS.
AND THESE PURE CAPSIDS HAVE
EXACTLY THE PROTEIN CONTENT
THAT YOU WOULD EXPECT SO
THEY'RE PURE AND THEY'RE
BIOLOGICALLY ACTIVE.
YOU MAY HAVE HEARD THERE IS
BEEN A REVOLUTION IN WHICH WHAT
IS CALLED CRIO YEM CAN NOW
DETERMINE STRUCTURES.
WE CAN USE CRYOEM TO LOOK AT
THE STRUCTURES.
AT OUR LABORATORY HERE IN
UNIVERSITY OF UTAH.
YOU CAN LOOK AT FREE PARTICLES
AND IF THEY TREAT THEM WITH
LENACAPAVIR THE INTERESTING
THING THAT HAPPENS IS THE
LATTICE BECOMES MORE RIGID, YOU
CAN SEE IT'S MORE ANGULAR AND
THE SIZE OF THE PENTMER ARE
EJECTED.
AND WE THINK THAT THIS IS
PROBABLY THE WAY IN WHICH
LENACAPAVIR WORKS.
THIS SAYS THAT IT'S POSSIBLE TO
SEE THE INDIVIDUAL CA HEXMERS
AND THE BINDING SITES FOR THE
DRUGS.
YOU CAN SEE THAT THE DENSITY
MATCHED WITH THE LENACAPAVIR.
SO NOW WE CAN TAKE AUTHENTIC
VIRUS BIND DRUG TO THEM AND SEE
WHAT THE AFFECTS ARE.
AT THE SAME TIME, MY LAB HAS
BEEN, I DON'T WANT TO GO
THROUGH ALL OF THESE, BUT MY
LAB HAS BEEN WORKING ON
PURIFYING THESE PARTICLES.
WE CAN DO THAT, WE CAN TAKE
ADVANTAGE OF DISCOVERIES BY LEO
AND OWEN THAT A SMALL MOLECULE
WILL STABILIZE THE CORES AND
NOW WE CAN DO BIOCHEMISTRY ON
THEM.
AND IF WE ADD THE M.P. Ts, THEY
WILL GO AHEAD AND REPLICATE THE.
NOW WE CAN MAKE FULL DNA JUST
AS THE VIRUS WOULD DO IT BUT
NOW WE'RE DOING IT IN BULK AND
WE CAN DO THAT AT HIGH
EFFICIENCY AND IF WE GIVE A
PLASMA DNA THEN THE VIRUS WILL
GO AHEAD AND INTEGRATE.
SO NOW WE CAN DO A FEW STEPS
WITH PURE HOMOGENEOUS REAGENTS
SO WE'RE EXCITED ABOUT WATCHING
THE AND UNDERSTANDING THEM MUCH
BETTER THAN WE CURRENTLY DO.
I THOUGHT I WOULD FINISH WITH A
PERSONAL NOTE OF THANKS AND
TELL YOU BY MY OWN JOURNEY.
I STARTED OUR LAB IN 19922
--1991, --1992 AT THE
UNIVERSITY OF UTAH, I REALIZES
THAT I WAS NOT SURE WHAT OUR
LAB SHOULD WORK ON.
SO I ASKED FOR A LITTLE BIT OF
EXTRA TIME BEFORE REPORTING FOR
DUTY TO THINK ABOUT WHAT WE
SHOULD WORK ON.
AND WE WERE FORTUNATE TO BE
DOWN THE HALL FROM A GOOD HIV
LAB.
AND I DECIDED THAT OUR NEW LAB
WAS GOING TO WORK ON HIV BUT IT
DIDN'T MAKE SENSE FOR A NEW
PROFESSOR TO WORK ON THE 'EM
ENZYMES, THERE WAS ALSO A
STRATEGY.
SO WE DECIDE TODAY WORK ON HIV
ASSEMBLY.
WE START TODAY GENERATE
PRELIMINARY DATA AND THREE
YEARS LATER, I SUBMITTED MY
FIRST GRANT AND IT GOT TRIAAGED.
THE FUNDING WAS LOW AND I TOLD
MY GROUP, WE HAVE TO DO 60
PERCENTILE BETTER.
BUT UNFORTUNATELY WE FIGURED
OUT HOW TO WRITE SUCCESSFUL
R.O.GRANTS WHICH HAS BEEN
CRITICAL FOR OUR LAB AND WE'VE
HAD GREAT PROGRAM OFFICERS LIKE
CARL AND LEA AND OTHERS ALONG
THE WAY.
SO IN 2002, NI G.M. S DECIDE
TODAY APPLY FOR A PROGRAM AND
WE APPLIED ON ASSEMBLY AND WE
DID THAT AND THAT WAS REALLY
IMPORTANT FOR US BECAUSE WE CAN
ADD GRAN JOHNSON, MICHAEL K WHO
WORKS ON ENTRY AND IS A CHEMIST
SO THAT MEANS WE CAN TACKLE
PROBLEMS MORE BROADLY.
IN 2007 THEY TURNED IT INTO A P
5 PROGRAMS SO NOW WE CAN ADD
PEOPLE DOING REAL VIROLOGY THAT
WAS AN EXCITED TIME BECAUSE WE
CAN TACKLE PROBLEMS FROM THE
BEGINNING TO THE END.
AND AS YOU MAY KNOW, IN 2019,
THAT PROGRAM MOVED IT'S NOW THE
U54 PROGRAM.
ART CENTER HAS CONTINUED TO
GROW AND THIS REPRESENTS THE
FACT THAT WE'RE NOW IN NIAID
WE'VE GROWN AND ALSO TACKLED
SOME ADDITIONAL PROBLEM
ESPECIALLY IN VIRAL DYNAMICS.
SO WE NOW HAVE PEOPLE WORKING
ON LIVING MODEL SYSTEMS AND
LOOKING AT THE TRANSMISSION AND
REBOUND OF THE VIRUS.
SO, DURING THE NI G.M. S DAYS,
THE PROGRAM WAS RUN BY DAVE AND
I WANT TO THANK THEM.
SO DAVE McDONALD IS OUR PROGRAM
MANAGER, HE'S A VIROLOGIST SO
HE SPEAKS OUR LANGUAGE, HE
COMES TO ALL OF OUR VIDEO
CONFERENCE SXZ MAKES GREAT
SUGGESTIONS ESPECIALLY HOW WE
CAN CONNECT TO THERAPEUTIC
CONVERSATIONS.
I WANT TO THANK CARL BEINGER
HE'S HERE, HE'S THE DIRECTOR OF
DAIDS.
ABOUT A YEAR AGO, I GOT A CALL
AND HE ASKED IF I WOULD WRITE A
LETTER OF REFERENCE.
SO I WAS TOUCHED AND DID IT.
IN SPITE OF THAT, HE GOT THE
JOB AND I THINK HE'S BEEN A
GREAT DIRECTOR.
AND THEN I WANT TO THANK LAST
BUT NOT CERTAINLY LEAST, DIA
NA, AS YOU HEARD, SHE IS
RETURNING, FORTUNATE FOR US, TO
HER PREVIOUS POSITION AND SHE
HAS BEEN A CHAMPION.
FOR EXAMPLE WHEN OUR CENTERS
START TODAY GET TOGETHER, WE
HELD EVENING MEETINGS AND SHE
WENT TO ALL MEETINGS AND MADE
GREAT CONNECTING SUGGESTIONS.
SHE'S THE FIRST THAT TOLD ME
ABOUT THE AIDS--PROGRAM SO
THANKS TO DIA NA.
I WANT TO EMPHASIZE WHAT GERRY
SAID AT THE BEGINNING, THIS IS
BEEN I LONG JOURNEY AND WE
COULD NOT HAVE DONE IT WITHOUT
THIS SUPPORT.
SO DIANA SAID, I COULD MAKE
SOME OPINIONS.
I THOUGHT I WOULD MAKE FIVE
SCIENTIFIC POINTS AND FIVE
QUICK SORT OF POINTS ON POLICY.
SO ONE OF THE THINGS I THINK
WE'VE LEARNED THROUGH OUR WORK
AND OTHERS, IS THAT NATURE
COMPARTMENTALIZED, IT HAPPENS
WITHIN THE CAPSID.
SO THE VIRUS WANTS TO KEEP ALL
THE 'EM SIGNS TOGETHER WITH THE
GENENON AND USE THE CAPSID TO
CAT LIES THE STAGE OF
REPLICATION SO WE'RE ACTIVELY
TRYING TO UNDERSTAND THAT.
AND THIS IS TRUE, MOST VIRUSES
BUILD VIRAL REPLICATION
FACTORIES THAT HOLD EVERYTHING
TOGETHER.
ONE OF THE SURPRISES HAS BEEN
THAT VIRAL CAPSID HAVE BEEN
GENICKLY FRAGILE.
SO WHEN THE WORK STARTED EVERY
ONE THOUGHT OF THE CAPSID AS A
ROCK AND PURE DRUG TARGET
BECAUSE THEY HAD TO HIT IT WITH
MULTIPLE DRUGS.
AND WHAT WE NOW KNOW IS THAT AT
LEAST IN THE CASE OF HIV, THE
CAPSID IS VERY FRAGILE.
AND I THINK BECAUSE THE CA
PROTEIN HAS TO DO SO MANY
THINGS AS I EMPHASIZED.
BUT ALSO BECAUSE THE CAPSID IS
SORT OF ENERGETICKLY BALANCED.
IT HAS TO ASSEMBLE INTO A
CAPSID BUT THEN DIS ASSEMBLE TO
REVERSE DNA AND THAT MEANS IT
DOES NOT HAVE MUCH MARGIN FOR
ERROR.
MANY OF YOU WILL KNOW THAT DRUG
COMPANIES HAVE SHYED AWAY FROM
PROTEIN PROTEIN INTERACTIONS
BUT THAT'S WHAT LENACAPAVIR
TARGETS.
AND THEY DESERVE CREDIT THAT
THIS IS A CASE BY CASE BASIS.
IF YOU HAVE A DEEP CONSERVE
POCKET THAT PROTEIN PROTEIN
INTERACTION CAN BE JUST AS GOOD
AS ENZYME IN TERMS OF
INHIBATION.
I'VE BEEN A CONSULTANT FOR
SEVERAL DRUG COMPANIES AND
OFTEN TIME WHEN THEY IDENTIFY A
DRUG SCAFFOLD AND IT'S
INSOLUBLE, THEY THROW THAT AWAY
AND THAT'S BECAUSE IF YOU NEED
AN ACUTE NEED FOR DRUG, YOU
WANT IT TO BE SOLUBLE.
BUT LENACAPAVIR IS SLOWLY
LEECHES OUT AND THAT MEANS THAT
IT CAN LAST FOR SIX MONTHS.
BUT THAT ALSO REQUIRES THAT IT
BE A VERY POTENT INHIBITOR AND
THAT CREDIT THAT THEY'VE BEEN
ABLE TO MAKE SUCH POTENT
INHIBITOR.
BUT THIS IS A BENEFIT NOT A
PROBLEM.
AND FINALLY, NO ONE SHOULD
UNDERESTIMATE THE HUMAN
BEHAVIOR.
I DID NOT TALK ABOUT IT A LOT
BUT IT WORKS WELL WHEN PEOPLE
ARE ADHERENT BUT IN OTHER
COUNTRIES, PEOPLE BECOME NON
COMPLIANT.
IN STUDIES IT TURNED OUT AFTER
SIX MONTHS THAT 80 PERCENT OF
THE PEOPLE DIDN'T HAVE THE DRUG
IN THEIR SYSTEM.
AND SO WHAT SORT OF MAGIC OF
LENACAPAVIR IT ENFORCES GOOD
BEHAVIORLE YOU GET ONE
INJECTION AND IT LAST FOR SIX
MONTHS.
SO THAT'S TURNED OUT TO BE VERY
IMPORTANT.
THEN, IN SCIENTIFIC TERMS, I
WANT TO EMPHASIZE THAT LONG
TERM AND FINANCIAL SUPPORT WERE
CRITICAL, YOU KNOW WE'VE BEEN
DOING THIS FOR 30 YEARS AND IT
WAS REALLY IMPORTANT FOR US TO
GET CONSISTENT FUNDING AND ALSO
SUPPORT AS I SAID, WE
APPRECIATE THE NIH PROGRAM
SUPPORT.
SO, I GUESS IT WOULDN'T
SURPRISE YOU THAT I'M A FAN OF
BASIC SCIENCE.
AND I WANT TO EMPHASIZE THAT
DISCOVERY AND TRANSLATION AND
IMPLEMENTATION, THE ENTIRE
SPECTRUM IS CRITICALLY
IMPORTANT, I TRULY BELIEVE THAT.
BUT I THINK THAT WE SOMETIMES
UNDERESTIMATE UNDERSTANDING HOW
SYSTEMS WORK.
SO I THINK IT WOULD NOT HAVE
BEEN EXPECTED THAT THE CAPSID
WOULD BE A GOOD DRUG TARGET AT
THE BEGINNING OF THIS JOURNEY
AND OTHER EVEN BETTER EXAMPLES
THROUGHOUT BIOLOGY.
SO AS YOU KNOW, THE INITIAL
INNATE IMMUNE STUDIES THAT LEAD
TO THE MRNA VACCINES THAT IS
TAKING OVER AND REVOLUTIONIZING
VACCINE DEVELOPMENT, THE SAME
IS TRUE FOR THE CRISPER 9
SYSTEM THAT BEGAN AS BASIC
STUDIES OF BACTERIAL DEFENSE
SYMPTOMS AND IT'S NOW GOING TO
REVOLUTIONIZE GENERALITY I CAN
MEDICINE.
ON TIMES WE CANNOT PREDICT BUT
ALMOST ALWAYS TURNED OUT TO BE
IMPORTANT TO UNDERSTAND IN
MONTH --MOL ELAR.
IT CAN BE PAINFUL TO WATCH LABS
TRY TO DEVELOP INHIBITORS.
THAT'S TO SAY NOTHING OF
PRECLINICAL TRIALS.
BUT I BELIEVE IN THE ACADEMIC
INDUSTRY.
PEOPLE SHOULD DO WHAT THEY DO
WELL AND NOT SURPRISINGLY, I
THINK THE TWO GROUPS HAVE GREAT
RESPECT FOR EACH OTHER.
ONE OF THE THAINGZ WE LEARNED
IS PROGRAM I CAN SCIENCE CAN BE.
IF YOU PUT TWO TEAMS IN THE
SAME ROOM, THEY SHOULD BE ABLE
TO TACKLE PROBLEM IN DIFFERENT
WAYS.
I BELIEVE THAT SCIENTIST HAVE A
BASIC NEED THAT THEY FEEL LIKE
THEY'RE IN THE SAME TEAM THAT'S
THE GREAT THING ABOUT THE UB54
PROGRAM.
AND MAYBE CONTROVERSIAL, I
THOUGH I I BELIEVE IN TEAM
SCIENCE WE HAVE TO BE CAREFUL
OF SCALING IT CORRECTLY.
IF WE UNDERSTAND, THEN IT CAN
MAKE SENSE TO HAVE LARGE TEAMS.
BUT WHEN WE DON'T, SOME OF THE
SECRET SAUCE OF THE U54 PROGRAM
IS THAT WE HAVE SIX DIFFERENT
PROGRAMS AND WE'RE ALL BIG
ENOUGH TO MAKE A DIFFERENCE WE
OFTEN WORK TOGETHER BUT
SOMETIMES COMPETE AND TACKLING
PROBLEM FRZ DIFFERENT ANGLES
AND THAT'S IMPORTANT FOR THE
STATE OF OUR UNDERSTANDING.
SO I'M GOING TO FINISH BY THANK
WE'VE HAD AMAZING COLLABORATE
ORS, I TRIED TO MENTION MANY OF
THEM.
WE'VE HAD THIS GREAT
RELATIONSHIP WITH GELIAD, TOM
ADD ME TO CALL THE GROUP, THE
GIL YAT TEAM AND THEY DESERVE A
LOT OF CREDIT FOR DEVELOPING
LENACAPAVIR.
I WANT TO ACKNOWLEDGE OUR
SUPPORT AS THE CHEETAH CENTER
FROM THE DADES U54 PROGRAM.
THIS IS THE UNIVERSITY OF UTAH
HEALTH SCIENCES CENTER.
I'M SITTING IN THAT BUILDING
RIGHT THERE TALKING TO YOU.
THAT'S MY HOUSE, SO I COME UP
EVERY MORNING A HILL AND I GET
TO SEE THE MOUNTAINS IN FRONT
OF ME WHICH I FIND INSPIRING
AND ALL OF THESE PEOPLE
INSPIRING AS WELL.
SO THANKS TO THEM FOR THEIR
CONTRIBUTIONS AND THANKS TO YOU
FOR YOUR ATTENTION.
I'M HAPPY TO TAKE QUESTIONS.
>> THANK YOU, DR. SUNQUIST FOR
THAT FASCINATING PRESENTATION.
I SEE WE HAVE A FEW QUESTIONS.
DR. KNEELAND I SEE YOUR HAND
FIRS
>> THANK YOU DR. SUNQUIST FOR
COMING IN AND SPEAKING TO US
TODAY AND THE WORK OF SO MANY
PEOPLE I LOST COUNT AFTER 20
CONTRIBUTED TO THE STUDY OF
LENACAPAVIR AND THE STUDIES YOU
SHOWED WITH ZERO HIV INFECTIONS
THAT THAT PREVENTION STUDY.
SO I HAVE A COMMENT AND A
QUESTION.
HIV PRICES ARE A MAJOR BARRIER
TO ACCESS, DAILY GENERIC, IS
LESS THAN 150 PER YEAR,
LENACAPAVIR IS 42,000 PER YEAR
IN U.S.
YOU MENTIONED, WOULDN'T CHARGE
GENERIC CHAMPIONS SIX OF THEM
TO MANUFACTURE HOPEFUL LOW AT
LOWER PRICES.
TWO EXAMPLES BUT LEN WILL NOT
BE AVAILABLE UNTIL 2027 SO
THAT'S THREE YEARS AFTER THE
ANNOUNCEMENT DURING WHICH TIME
MILLIONS WILL BE INFECTED WITH
HIV
AND SECOND MANY INTERMEDIATES
NECESSARY FOR THE API THAT
AREN'T COVERED IN THE MEETING
AND THOSE INGREDIENTS CAN STILL
BE VERY EXPENSIVE AND THE
COMPANIES HAVE NOT YET
ANNOUNCED A PRICE.
AND THAT'S THE COMMENT AND NOW
THE QUESTION.
YOU HAVE BRIDGED FEDERAL AND
PRIVATE SECTOR SUPPORT.
AND I GUESS I WONDER WHAT
SUGGESTIONS DO YOU HAVE TO NIH
WHERE WE CAN BOTH INCENTIVIZE
TO DRIVE INNOVATION.
AND RESULTS AND ALSO THE
ULTIMATE PRICE ALSO ACCOUNTS
FOR TAXPAYER INVESTMENT IN THE
PRODUCT.
>> YES, SO THOSE ARE OBVIOUSLY
VERY IMPORTANT QUESTIONS THANKS
FOR ASKING THEM.
I THINK I'LL BE CAREFUL ABOUT
THE POLICY QUESTIONS BECAUSE
I'M NOT A POLICY PERSON.
BUT I ACTUALLY WAS REASONABLY
SHOCKED AT THE TIME SCALE OF 20
TP WHEN IT CAME OUT SO I SHARE
YOUR CONCERN WITH THAT.
I GUESS IT LOOKS LIKE WE HAVE
AN AMAZING TOOL, THE POLICY AND
THE IMPLEMENTATION SHOULD MATCH
THAT TOOL IN 2027 JUST SEEMS
ALMOST UNACCEPTABLE TO ME, AS
YOU SAY, THERE IS GOING TO BE
MILLIONS OF PEOPLE INFECTED.
SO I GUESS, I DON'T FEEL
QUALIFIED TO SAY HOW WE SHOULD
CHANGE IT BUT I BELIEVE WE
SHOULD CHANGE IT.
I THINK, YOU KNOW, WE HAVE TO
THINK ABOUT THIS, IS IT THE
GATE'S FOUNDATION, THAT IS HUGE
NUMBERS OR I WANT TO BE CAREFUL
ABOUT SUGGESTING POLICY BUT
EVERYTHING HAS TO MOVE FAST
BECAUSE THESE ARE HUMAN LIVES.
SO I COMPLETELY AGREE WITH THAT.
IN TERMS OF, OF PUBLIC PRIVATE
PARTNERSHIPS, WE HAVE BEEN
ALTHOUGH I WAS A CONSULTANT FOR
GILADD AND THEY GAVE US SPONSOR.
SO IT WAS SORT OF SEMI
INDEPENDENT, WE WERE TALKING A
LOT BUT, WE DIDN'T DO THAT, AND
AT LEAST IN OUR CASE, THAT
WORKED WELL.
I THINK THAT WE WERE DOING WHAT
WE DO BEST AND WE WERE HAVING
FUN TALKING TO THEM AND THEY
WERE DOING WHAT THEY DO BEST.
FOR US, WE DIDN'T REALLY NEED
AN INCENTIVIZATION TO WORK WITH
THEM.
BUT WE DID NEED INDEPENDENT
FUNDING BECAUSE IF WE HADN'T
HAD IT, WE WOULD NOT HAVE BEEN
A PARTNER IF THAT MAKES SENSE.
I'M AWARE OF THE PROGRAM FOR
EXAMPLE WHERE IT'S MUCH MORE
INTEGRATED WITH INDUSTRY.
AND I GUESS, I DON'T HAVE A
INTELLIGENT COMMENT TO MAKE.
I THINK IT'S REALLY IMPORTANT
TO WORK WITH INDUSTRY.
WHEN YOU SEE HOW THEY DO
THINGS, IT'S IMPORTANT FOR LABS
TO DO THINGS.
BUT I FEEL LIKE I SHOULD BE
CAREFUL ABOUT NOT ADVISING ON
HOW TO DO IT EXCEPT TO DO IT
HOW IT HAPPENED WITH OUR CASE.
>> THANKS SO MUCH.
>> DR. LIGAVI.
>> THANKS FOR A GREAT TALK.
AND A GREAT HIGHLIGHT OF THE
FUNDAMENTAL IMPACT OF THE BASIC
SCIENCE OF DEVELOPMENT OF
INNOVATIVE THERAPIES AS
EVERYBODY ELSE AND GERI AND
DIANA POINTED OUT.
SO AS A BIG FAN OF SCIENCE, MY
QUESTION IS LENACAPAVIR
FORMATION AND IMMATURE
PARTICLES.
IT MENTIONED THAT IT FLATTENS
THE CAPSID BUT IT DOES IT ALSO
INHIBIT CAPSID FORMATION?
OR BOTH?
SO THOSE ARE PRETTY GOOD GOOD
QUESTIONS AND I WENT FAST
THROUGH THAT.
I WOULD SAY WORK IS AS NICE AS
ANY RIGHT NOW.
AND WHAT THEY SHOW ONCE THEY
FORM A CAPSID.
THE DRUG WAS DEVELOPED BY
STIMULATING, SO IT BINDS TO THE
HEXMER AND THAT MEANS IT GOES
BETTER.
BUT IT ALSO STRANGLES THE
HEXMER, IF YOU THINK ABOUT THE
CONE, IT HAS TO CHANGE IN THE
CONE.
SO WHAT I THINK IT RA DIT FIES
THE LATTICE AND TO* GO FLATTER
SO THEY START TO POPOFF SO YOU
PROBABLY HAVE A MORE FRAGILE
CAPSID.
IT DOESN'T BIND TO THE PENTMER
SO THAT'S KIND OF INTERESTING
AS WELL.
SO I THINK THAT'S COMBINATION I
THINK THAT CAPSID IS POISED AT
THE RIGHT ENERGY AND IF YOU
FORCE IT TO ADOPT TO SLIGHTLY
DIFFERENT LATTICE THAT IT'S NOW
VERY VULNERABLE I THINK THAT'S
OUR BEST UNDERSTANDING.
>> THANKS.
>> DR. SAWYER.
>> HI, THIS IS DR. SAWYER.
WHO DOES GILADD INTEND THE AWED
UDIENCE FOR THIS DRUG?
LIKE PEOPLE LIVING HIGH-RISK
LIFE STYLES ARE OBVIOUSLY.
BUT ABOUT THE YOUNG WOMEN THAT
GETS HIV BY GETTING RAPED.
OR WHAT ABOUT THE WOMEN THAT
THINKS SHE'S AN MONOGAMOUS
MARRIAGE AND FINDS OUT SHE'S
NOT AND GETS AIDS.
AND IF THE HIGH-RISK POPULATION
IS THE MAIN TARGET, I WOULD BE
INTERESTED IN HEARING WHAT
THEY'RE THINKING ABOUT THAT, IF
THAT IS THE MAIN TARGET?
WHAT DOES BEHAVIORAL SCIENCE
SAYS ABOUT ADHERE WHO THAT
PEOPLE WILL BE SIX-MONTH
INTERVENTION LIKE THIS.
>> SO AS YOU KNOW, I'M AN
EXPERT ON NONE OF THOSE TOPICS
BUT I WILL STILL TELL YOU BUT
CAREFUL.
I THINK IT'S ENVISIONED AS
HIGH-RISK BASICALLY AS A
VACCINE BUT AT THE BEGINNING IT
WILL BE FOR HIGH-RISK
POPULATIONS.
THE ONE THING THAT I DON'T
AGREE, I AGREE WITH MOST WHAT
YOU BUT THE VERY LAST THING
THAT THESE GROUPS ARE NOT
LIKELY TO BE COMPLIANT.
THAT'S WHAT I THINK WAS TESTED
OVER THE ONE-YEAR TIME SCALE
AND IT SHOWS THAT THEY ARE
ADHERENT BY VIRTUAL THAT THEY
GET INJECTION AND NOT JUST SIX
MONTHS BUT EVEN LONGER.
THAT'S THEIR BUSINESS BUT NOT
MINE TO TALK ABOUT.
I GUESS, I THINK THAT IT
PROBABLY, YOU KNOW, EVERYBODY
IS GOING TO HAVE TO DO TOUGH
COST BENEFIT ANALYSIS, NOT
EVERY ONE IS GOING TO GEL
LENACAPAVIR SO ONE HAS TO THINK
AT WHAT POINT DOES THE COSTS IN
TERMS OF THE GIVING A DRUG TO
PEOPLE EXCEED THE BENEFIT
BECAUSE AS YOU SAY, WE GET HIV
INFECTIONS FROM ALL DIFFERENT
DIRECTIONS BUT CLEARLY IN THE
PREVALENT AREAS, YOU KNOW, 2.4
INFECTIONS PER 100, SO PEOPLE
ARE REALLY GETTING INFECTED SO
THAT POPULATION AND OTHERS
WOULD BENEFIT FROM THIS IF IT
CONTINUES TO WORK WHICH IT
LOOKS LIKE IT WILL.
>> THANK YOU.
>> DR..
>> THANK YOU, WHAT A GREA
PRESENTATION, AND I WOULD LIKE
TO ANSWER DR. SAWYER'S QUESTION
BUT I'LL HOLD BACK.
I HAVE HAD AN QUESTION.
YOU GAVE A GREAT STORY, THIS IS
THE KIND OF THING THAT NIH
WANTS TO PUT ON THEIR WEBSITE
TO SHOW HOW BASIC SCIENCE LEAD
OVER TWO DECADE PERIOD TO THE
MOST NEW INNOVATION THAT WE
HAVE IN HIV PREVENTION IN A
LONG TIME.
MY QUESTION, FOR YOU IS,
IMAGINE, YOU KNOW, YOU'RE DR.
DONEBERGH AND YOU JUST TOOK
OVER OAR AND YOU ARE THINKING
OF HOW TO PRIORITIZE THE MOST
BASIC SCIENCE, BECAUSE YOU TOLD
THE STORY OF THE NUMBER RATER,
THE SUCCESSFUL NUMBER RATER,
AND YOU WERE SELECTED FOR THIS
PARTICULAR EVENT BECAUSE YOU
SUCCEEDED, THERE ARE PROBABLY 9
OUT OF 10 BASIC SCIENCE STUFF
HAVE NOT COME TO FRUITION YET
TO SOMETHING THAT HAS NOT HAD A
MEANINGFUL AFFECT ON PUBLIC
HEALTH.
AND I'M WONDERING ARE THERE
PARAMETERS OR IDEAS THAT THE
TEAM USES TO TRY TO
DIFFERENTIATE EARLY ON, NOT
BETWEEN QUALITY OF SCIENCE,
BECAUSE THE QUALITY OF SCIENCE
CAN BE GREAT BUT MEANINGFULNESS
OF BASIC SCIENCE SO IT HAS A
HIGHER LIKELIHOOD OF FINDING A
HOME IN HEALTHCARE SUCCESS
WITHIN THE NEXT TWO DECADES?
BECAUSE HIV TWO DECADES IS A
LONG TIME.
>> I'LL START AND I'LL THEN
CARL SAY WHAT THEY WANT.
ONE OF THE THINGS THAT I THINK
WE HAVE TO BE CAREFUL IS,
MICROMANAGEMENT.
BECAUSE I THINK IF YOU TAKE ALL
THE EXAMPLES THAT I TALKED
ABOUT.
WE DIDN'T REALLY KNOW THAT
DISCOVERY THAT WAS GOING TO
COME OUT AT THE OTHER END.
SO I THINK, IF YOU HAD SAID
OKAY, WHAT'S THE MOST LIKELY
DRUG TARGET, YOU WOULD NOT HAVE
PICKED THE CAPSID.
AND SO, OF COURSE FIRST OF ALL,
FIRST AND FOR MOST, QUALITY IS
IMPORTANT.
IT REALLY IS, WE SHOULD BE
FUNDING THE BEST RESEARCH AND
THE BEST RESEARCH WHO CAN
ARTICULATE WHY THE PROBLEM IS
FUNDAMENTAL.
SO I DON'T THINK THAT ALL
RESEARCH IS EQUAL BUT I THINK
IT'S HARD, AND IT HAS BEEN HARD
TO MICROMANAGE EXACTLY, SO IT'S
OBVIOUS AND WE SHOULD DO THIS
WHEN WE CAN THAT WE SHOULD
ATTACK THE ENZYMES THAT THAT
WAS A GOOD PAIR DIME
THAT--PARADIGM THAT WAS GOING
TO HAPPEN.
BUT ONCE YOU UNDERSTAND HOW
THINGS WORK, THEY'RE OFTEN
UNEXPECTED SO. MY OWN VIEW IS
SHOULD BE CAREFUL NOT TO MAKE
TOO MANY POLICY DECISIONS TOO
EARLY.
BUT WHAT WE SHOULD DO, IS
PEOPLE LIKE MYSELF, TO USE A I
AND ALL OF THESE TOOLS THAT ARE
SPEEDING EVERYTHING UP.
WE HEARD A GREAT TALK
YESTERDAY, SORT ON THE FUTURE
OF DRUG DISCOVERY AND THAT WAS
HIS TAKE HOME MESSAGE.
THAT WE CANNOT BE SATISFIED
WITH ONE PERSON LIKE ME
STUDYING ONE PROTEIN, THE CA
PROTEIN FOR 25 YEARS, WE HAVE
TO BE FASTER.
I BELIEVE NA THAT BUT WE SHOULD
BE CAREFUL NOT TO MICROMANAGE
WHAT SCIENCE GETS DONE, THAT'S
MY OWN OPINION OBVIOUSLY.
>> I WOULD LIKE TO ADD TO THAT.
I THINK IT REALLY IS SOMETHING
WES SAID ABOUT THE DEGREES OF
COLLABORATION AND THERE IS A
POINT IN TIME WHERE COMPETITION
IS ESSENTIAL.
IN SCIENCE.
YOU WANT TO BE THE FIRST TO
DISCOVER SOMETHING BUT AS YOU
BUILD YOUR GROUP, YOU CAN GET
MORE INTEGRATED AND ADVANCED
IDEAS.
I DO AGREE THAT WE SHOULD NOT
GET INTO MICROMANAGING, BUT WE
ALSO CAN DO SOMETHING ABOUT
LOWERING THE BAR THE ACTIVATION
ENERGY TO GET INDUSTRY ENGAGED.
AND THAT IS ONE OF THE THAT'S
THE MAJOR TOOL THAT WE HAVE
CONTINUED TO USE HERE AT NIAD
TO COSTER A COLLABORATION
BETWEEN PHARMACEUTICAL AND
PEOPLE WHO ARE DOING BASIC
RESEARCH TO MAKE IT SO THAT
WHEN THERE IS SOMETHING THAT IS
WORTH AT LEAST HAVING A COMPANY
TAKE A LOOK AT IT, THAT THE
BRIDGE IS ALREADY BUILT.
THIS IS, YOU KNOW, A PRIME
EXAMPLE OF WHERE WE CAN GO WITH
THIS KIND OF FINDING IS THE
INFORMATION THAT HAS COME
AROUND CORONAVIRUS THAT IT TOO
ASSEMBLES A STRUCTURE THAT IS
QUITE RESILIENT AND DRUG DOES
NOT PENETRATE INTO DOES NOT GET
INTO THAT AREA AND SO THERE IS
A FORM LOGICAL PRIVILEGE SITE
THAO IT IT'S NOT AFFECTIVE.
SO YOU CAN LEARN FROM WES AND
THE CAPSID WORK IS ASSEMBLED
BUT NOW WE HAVE TO APPLY THAT
TO OTHER VIRUS.
BASIC RESEARCH IS ONE OF THE
CORE PURPOSES OF THE NIH AND AS
LONG AS WE ARE IN THE BUSINESS,
WE NEED TO MAKE SURE THAT WE
ARE SUPPORTING ENOUGH BASIC
RESEARCH SO THAT WE DON'T MISS
IDEAS.
THERE HAS TO BE ENOUGH WATER IN
THE STREAM TO FLOAT THE BOAT.
>> I'D ALSO JUST LIKE TO ADD
THAT BASIC SCIENCE IT IS AS YOU
SAY EXPENSE BUT NOBODY ELSE IN
THE WORLD THAT HAS THE
FINANCIAL ABILITIES TO BE ABLE
TO SUPPORT THIS TYPE OF WORK AT
THIS LEVEL.
I CANNOT THINK OF, I MEAN THERE
IS SOME COUNTRIES WHERE THERE
ARE BITS AND PIECES.
BUT YOU KNOW, THE NIH SUPPORT
IS REALLY BEYOND AND IT'S, YOU
KNOW IT'S A CROWN JEWEL IN THE
UNITED STATES BUT ALSO FOR THE
WORLD BECAUSE YOU JUST DON'T
KNOW WHERE YOU'RE GOING TO NEED
TO HAVE THIS FUNDAMENTAL
UNDERSTANDING WHAT PATHOGENS
REALLY LOOK LIKE IN DETAIL AND
HOW THEY IMPACT ON THE SCALES
THAT WES WAS DESCRIBING.
SO THAT'S MY PLUG FOR THE WORLD.
I THINK THAT THERE ARE OTHER
ASPECTS OF BEHAVIOR WHICH CAN
BE DONE IN OTHER PLACES.
SO AGAIN, I THINK BASIC SCIENCE
HOLDS A VERY IMPORTANT SPOT
ESPECIALLY AT THE NIH.
>> NOT SURPRISINGLY I AGREE WE
HAVINGER THAT WAS SAID.
BUT I WILL SAY THAT THE PROGRAM
HAS BEEN GOOD ABOUT PUSHING US
TO THINK ABOUT TRANSLATION AND
THAT'S OUR NEXT STEP.
SO I ALSO THINK THAT'S BEEN AN
IMPORTANT ROLE WITH DIANA AND
OTHERS HAVE PERFORMED.
I DON'T THINK WE SHOULD BE ABLE
TO A STUDY THAT INTERESTS US
BUT SOMETHING THAT MATTERS AND
CAN AND SHOULD BE TRANSLATED.
BUT I HATE AS A CHAIR OF
BIOCHEMISTRY DEPARTMENT AND
MEDICAL SCHOOL, WE HAVE TO MORE
TRANSLATION AL, WHAT PEOPLE
NEED TO DO IS REALLY GOOD
SCIENCE AND GOOD THINGS WILL
HAPPEN BUT WE CANNOT EXACTLY
PREDICT HOW.
>> WE HAVE TIME FOR ONE MORE
COMMENT, DR. MONTANER.
>> I WAS JUST GOING TO ECHO THE
POINT OF ENGAGEMENT.
I'LL PERHAPS BE MORE SPECIFIC,
DR. SUNQUIST, I MEAN YOU HAVE
30-YEAR TIME SPAN IN YOUR
CAREER THAT HAS EXPERIENCED THE
SUCCESS AND ADVANCE WHAT
ULTIMATELY LEAD TO A SUCCESSFUL
SUCCESSFUL INDUSTRY AND NOW
DRUG.
AS YOU LOOK BACK, DO YOU THINK
WHAT TYPE OF SUGGESTIONS DO YOU
HAVE FOR NEW ACADEMIC
PARTNERSHIPS?
WE HAVE THE SBRR AND THEY WRITE
THOSE, THEY ADD US AS
COLLABORATERS, BUT WE DON'T
REALLY HAVE AN INDUSTRY PIECE
THAT IS FUNDED DIRECTLY AT
LEAST MOST GRANTS DON'T HAVE A
COMPONENT GOING TO MARK OR
GILAD SO TRY TO INCENTIVE
GROUPS TO WORK AND GET THEIR
GRANTS.
BUT WHEN YOU LOOK AT YOUR WHOLE
TIME LINE, I MEAN, DO YOU, DO
YOU, WHAT TYPE OF TOOLS OR
GRANT INSTRUMENTS DO YOU THINK
WOULD HAVE ACCELERATED THIS
TYPE OF RELATIONSHIP?
BECAUSE YOU KNOW, I GUESS IT'S
ADVISORY WE HAVE TO BE KIND OF
LIKE TROUBLESHOOT NEW THINGS
THAT COULD BE ADVANCE THE FIELD.
I'M INTERESTED TO HEAR WHAT
YOUR PERSPECTIVE IS ABOUT WHAT
TYPE OF GRANT STRUCTURE OR TYPE
OF INITIATIVE WOULD YOU HAVE
LIKED TO HAVE SEEN?
>> THAT'S A REALLY GOOD
QUESTION AND I WISH I WAS
BETTER PREPARED TO GIVE YOU A
GOOD ANSWER.
I NEVER FELT THAT THERE WERE
BARRIERS, WE HAD GOOD
RELATIONSHIPS, THEY WERE DOING
THEIR OWN THING AND WE WERE
DOING OUR OWN THING.
BUT I REALLY ENJOYED GIVING
THEM ADVISE AND HEARING ABOUT
THEIR ADVANCES.
IN MY OWN CASE, THAT WOULD HAVE
BEEN HARDER TO INCENTIVIZE.
BUT IN MY DEPARTMENT, SOMETHING
THAT I SEE HAPPENING
SUCCESSFULLY.
ONE OF THE THINGS THAT WE
DIDN'T DO WELL, IS
COMMERCIALIZE THINGS AND THAT'S
WE HAVE A NEW GENERATION OF
YOUNG FACULTY WHO ARE DOING
THAT BETTER BY STARTING
COMPANIES AND NOT RUNNING THEM,
TRYING TO RUN COMPANIES BUT
THEY SHOULD TRY TO SPIN THEM
OFF.
SO I THINK THAT INCENTIVIZING
THAT IS OFTEN, THOSE ARE OFTEN
DIRECTLY DIRECTED TO THE
DISCOVERIES THAT THEY'VE MADE
AND THEY ENSURE THAT SOMETHING
IS MAKING DOING SOME MEDICINAL
DISCOVERY AND THEY'RE OFTEN
PICKED UP BY BIGGER DRUG
COMPANIES.
THAT'S SOMETHING THAT I'VE SEEN
IN MY DEPARTMENT, JERED ONE OF
THE LEADERS IS DOING
DIFFERENTLY FROM WHAT WE DID
AND MAY HAVE MADE A DIFFERENCE
IN OUR CASE.
BUT IN OUR CASE, WE WERE SMART
NOT TO DO DRUG DEVELOPMENT AND
ESPECIALLY HAVING SEEN.
AT ONE POINT, THEY HAD 25
DIFFERENT CHEMIST ACADEMIC LABS
SHOULD NOT DO THAT.
>> THIS IS BEEN A FABULOUS
CONVERSATION.
I KNOW --
~>> IVY CAN I MAKE ONE MORE
COMMENT.
>> YES, I DIDN'T SEE YOUR HAND.
>> YES, I THINK THE OTHER SORT
OF THROUGH LINE IN DR. SUNQUIST
TALK WAS THE TOOL DEVELOPMENT.
AND THAT WAS THE IMPROVEMENT IN
MICROSCOPY, THE IMPROVEMENT
WHERE YOU CAN NOW LITERALLY
DETERMINATION USING CRIO EM.
AND THE STRENGTH OF THE U54
PROGRAMS BOTH THE G.M. WAS
MAINTAINING THIS, THAT THE GOAL
IS NOT JUST DISCOVERY OF
BIOLOGY BUT ALSO IMPROVEMENT OF
THE TOOLS THAT WERE WE'RE USING
TO MAKE SHE'S DISCOVERIES.
SO G.M. AND NI A ID HAVE
INVESTED CLOSE TO 15-20 YEARS
AND THAT IS ANOTHER MAJOR
FACTOR IN THIS.
SO IN MY MANY WAYS HIV WAS THE
TEST CASE FOR AN AIDS WAS THE
PLACE TO DO THAT BECAUSE WE HAD
THE LEVEL OF SUPPORT THAT
ALLOWED FOR THESE CENTERS TO
COME TOGETHER AND ENGAGE IN
OPERATIVE TOOL DEVELOPMENT
WHILE SOLVING THE MOST
IMPORTANT PROBLEMS FOR WHAT I
CONSIDER THE MOST IMPORTANT
DISEASE, STILL IN THE WORLD.
>> I KNOW WE'RE RUNNING LATE ON
TIME, BUT I SHOULD HAVE SAID
THAT, I ENDORSE THAT 100
PERCENT.
WE HAD ELI HERE YESTERDAY, THEY
BUILT THEIR ENTIRE FACILITY.
AND THAT CAME OUT BECAUSE
EVERYBODY SHOWED THE CRIO EM
AND HOW FAR SRS BECAUSE THEY
KNEW HOW TO DO IT.
SO WOO CARL SAID WAS 100
PERCENT CORRECT.
>> THANK YOU ALL FOR THIS
ENGAGEMENT IN THIS FABULOUS
INFORMATION.
DR. SUNQUIST THANK YOU AGAIN
FOR YOUR PRESENTATION, IT'S NOW
1:58 WE'RE GOING TO TAKE A
SHORT BREAK.
PLEASE BE BACK AT 2:05?
AND SO THAT WE CAN CONTINUE
WITH OUR MEETING AGENDA.
THANK YOU ALL.
WELCOME BACK FROM THE BREAK
EVERY ONE.
WE WILL BEGIN WITH THE OAR TASK
FORCES, REGARDING THE STRATEGIC
PLAN WITH HIV RELATED RESEARCH.
TO INTRODUCE THE TASK FORCE, IS
DR. BOND SOL, TASK FORCE
COORDINATOR AND SENIOR SCIENCE
ADVISOR FROM OAR.
PLEASE BEGIN WHEN YOU'RE READY.
I WILL PRESENT INFORMATION FOR
THE FORCES CONVENED.
AS PART OF THE DEVELOPMENT OF
THE ANNEX STRATEGIC PLAN FOR
RELATED RESEARCH.
SO I WANT TO START BY
ACKNOWLEDGING THE PEOPLE BEHIND
THIS EFFORT.
WITH COLLEAGUES AND THED
FORMATION OF THE EXTRA TAOEMG
--STRATEGIC PLAN AS THEY TASK
FORCE.
AND ALSO HERE TODAY AND I WOULD
LIKE TO ACKNOWLEDGE THE TASK
FORCE TEAM MY COLLEAGUES, DR.
LESLIE MARSHAL AND MS. AMBER
WILSON THAT SERVED AS THE
SECRETARIES FOR THE TASK FORCES
AND PROVIDED THE ADMIN SUPPORT.
NEXT SLIDE PLEASE.
SO AS DR. DONENBERG, THE
PROCESS YOU SEE THE ONSCREEN.
TASK FORCES ARE A PART OF THIS
ON GOING PROCESS AND ARE
REPORTING OUT THEIR
RECOMMENDATIONS TO THE ADVISORY
COUNCIL TODAY.
THE ADVISORY COUNCIL
RECOMMENDATIONS WILL BE SHARED
WITH THE DIRECTOR FOR HER
REVIEW AND INPUT AND NHICs
PORTFOLIO.
SO TODAY'S RECOMMENDATION ARE
NOT THE FINAL PRODUCT.
NEXT SLIDE, PLEASE.
GRATEFUL TO OUR CHAIRS FOR
THEIR HARD WORK IN MAKE THISING
EFFORT POSSIBLE AND THE MEMBER
OF OAR SCIENCE TEAM IN
FACILITATING THE AGENDAS AND
NEEDING MATERIALS ET CETERA.
NEXT SLIDE PLEASE.
THESE GROUPS WERE PURPOSEFULLY
PUT TOGETHER TO REPRESENT A
BROAD DIVERSITY OF SUBJECT
MATTERS EXPERIENCE IN PRACTICE
AND POLICY AS WELL AS LIVED
EXPERIENCES.
WE AIM TO REACH PARTICIPANT
WITH GLOBAL AND DOMESTIC
EXPERIENCE INCLUDING ACROSS
ACTION REPRESENTATION AS WELL.
NEXT SLIDE, PLEASE.
AND WE ARE REALLY THANKFUL FOR
ALL THE MEMBERS FOR THEIR HARD
WORK AND COMMITMENT TO THIS
IMPORTANT EFFORT.
NEXT SLIDE.
SO THE TASK FORCES WERE CHARGED
WITH DEVELOPING OR IDENTIFYING
A SHORT LIST FOR THE NEXT 5
FISCAL YEARS.
ALL TASK FORCE MEMBERS WERE
PROVIDED OBJECTIVE HOUT THE
PRIMARILY TASK FORCES WAS
IDENTIFYING PRIORITIES FOR
OBJECTIVES THAT ALIGN WITH THE
TASK FORCE EXPERTISE.
AND THE DELIVERABLE WAS A
FRAMEWORK WITH RECOMMENDED
PRIORITIES UNDER EACH OBJECTIVE.
SO THIS SHOWS THE TIMELINE AND
STRUCTURE OF THE MEETINGS.
WE START WITHED KICKOFF MEETING
WHICH WAS JOINT MEETING FOR ALL
TASK FORCES TO ENSURE THAT
EVERY ONE RECEIVES THE SAME
INFORMATION AND RESOURCES.
EACH TASK FORCE MET TWICE WITH
ADDITIONAL COMMUNICATION IN
BETWEEN FOR REVIEW AND ANY
ADDITIONAL SUGGESTIONS.
AND THE WRAP UP MEETING WAS
AGAIN JOINED FOR ALL TASK
FORCES TO BE ABLE TO SEE AND
DISCUSS EACH OTHER'S WORK AND
HOW EVERYTHING FIT TOGETHER AND
IF THERE WERE ANY MAJOR
OMISSIONS.
AND THE DELIVERABLE FROM THESE
TASK FORCES IS BEING THIS
PRIORITY RECOMMENDATION THAT'S
ARE REPORT TODAY OARAC TODAY BY
THE TASK FORCE CHAIRS.
NEXT SLIDE, PLEASE.
SO THE EXTRA TAOEMG I CAN
FRAMEWORK HAS ONE CAPACITY GOAL.
EACH THREE TO FOUR
OBJECTIVITIES.
THE FOCUS WAS ON RECOMMENDING
THE FUNDING PRIORITY UNDER
SPECIFIC OBJECTIVES.
NEXT SLIDE, PLEASE.
SO THIS SLIDE SHOWS SPECIFIC
OBJECTIVES THAT WERE THE
PRIMARILY FOCUS FOR EACH OF THE
TASK FORCE.
DIFFERENT FUNCTIONAL AREAS OF
SCIENCE WERE REPRESENTED WITH
EACH GOAL AS YOU CAN SEE.
AND THEREFORE DIFFERENT TASK
FORCES WORKED ON DIFFERENT
OBJECTIVES WITHIN THE SAME GOAL.
ALL THE TASK FORCES WEIGHED IN
ON OBJECTIVES RELATED TO
COMMUNITY AND ENGAGED RESEARCH
AND INFRASTRUCTURE AND CAPACITY
BUILDING AND THAT WAS DONE TO
BRING THE PERSPECTIVE FROM ALL
THE FUNCTIONAL AREAS OF SCIENCE.
SO TODAY IN ADDITION TO
PRESENTING RECOMMENDATIONS FOR
THEIR SPECIFIC OBJECTIVE EACH
WILL PRESENT RECOMMENDATIONS
FOR THE SHARED OBJECTIVES.
NEXT SLIDE.
TASK FORCE RECEIVED SAME
INFORMATION, SAME MATERIALS AND
WHILE DEVELOPING PRIORITIES
WERE ASKED TO CONSIDER THESE
THREE THINGS, FIRST THE
STRATEGIC PLAN FOUNDATIONAL
PRINCIPALS WHICH ARE EQUITY,
INCLUSIVENESS OF ALL
POPULATIONS AND SETTINGS,
COMMUNITY ENGAGEMENT AND
POTENTIAL FOR GREATEST PUBLIC
HEALTH IMPACT.
THEY HAVE PROVICED REFERENCE
AND RESOURCES WHICH ARE INPUT
THAT OARAC RECEIVED FROM
VARIOUS SOURCES AS DR. DO
NOT--DONENBERG MENTIONED.
AND KEEPING IN MIND, THE MULTI
DISCIPLINARY NATURE OF
PORTFOLIO.
SO NOW I WILL HAND OVER TO THE
CHAIRS.
>> I WILL START BY THANKING ALL
THE EXECUTIVE SECRETARIES FOR
THEIR INCREDIBLE SUPPORT, ON
BEHALF OF ALL THE CHAIRS, WE
REALLY HAD AMAZING SUPPORT
THROUGHOUT THE ENTIRE PROCESS.
PRIORITY SO IF WE START WITH
GOAL NUMBER 1 WHICH IS REALLY
ONE FOCUS ON DISCOVERY AND
BASIC RESEARCH BUT FUNDAMENTAL
RESEARCH, THE GOAL IS TO
PHYSIOLOGICAL AND INTERPERSONAL
AND SOCIAL MEMBERISMS WITH HIV
HOW IT OPERATES AS A VIRUS AND
INFECTIOUS DISEASE AND
INDIVIDUAL COMMUNITY AND
POPULATION LEVEL.
THIS REALLY IS THE FOUNDATION
FOR THE DEVELOPMENT OF SAFE AND
AFFECTIVE AND DESIRABLE TOOLS
TO PREVENT AND CURE PERSONS
LIVING WITH HIV AS WELL AS
REDICED RISK OF COMPLICATION
AND COMORBID CONDITIONS.
SO NOW WE'LL GO THROUGH EACH OF
THE OBJECTIVE SXZ SOME OF THE
PRIORITIES THAT WERE IDENTIFIED.
SO IF WE CAN GO TO THE NEXT
SLIDE, OBJECTIVE 1.1.
THIS ONE, WAS TACKLED BY THE
BASIC ENVIRONMENTAL RESEARCH
TASK FORCE AND REALLY ADDRESSES
THE UNDERSTANDING OF HIV
BIOLOGY, VIROLOGY AND
PATHOGENSIS.
BREAD, TRANSITION AND
PATHOGENSIS OF HIV
WITH EMPHASIS OF PROTECTIVE
IMMUNE RESPONSE.
THE TASK FORCE SORT OF DEFINED
THIS TO BE AREAS FOR FUNDING
PRIORITIES THAT WERE ADVANCE
THE UNDERING OF BASIC AND HOST
MECHANISMS ESTABLISHMENT
SPREAD, TRANSMISSION AND
PATHOGENSIS OF HIV THROUGHOUT
THE LIFE SPAN.
AND REALLY EMPHASIZE THE LIVE
SPAN AND STRATEGIC PLAN.
UNDERSTANDING THE MECHANIC SIFM
OF REACTIVATION PERSISTENT AND
TISSUE BASE RESERVOIR DYNAMIC
TO DEVELOP STRATEGIES FOR
ELIMINATING OR CONTROLLING HIV
RESERVOIR INCLUDING RESISTANCE
BARRIERS.
THIS DISCUSSION REALLY
EMPHASIZE THAT APART FROM THE
BASIC TENANTS OF ALL OF THESE
CORE OBJECTIVES, THE DIE
VERSUSITY AND CELL TYPE IS AN
AREA THAT WE ALL RECOGNIZE
WHICH IS AN IMPORTANT NEXT
FRONTIER.
NEXT IS EVALUATE RESPONSE TO
VACCINATION TO NEUTRALIZING
ANTIBODIES SUCH AS GENE THERAPY.
THERE WAS A LOT OF DISCUSSION
THAT PRIORITY OF VACCINE AND
HOW WE NEED TO UNDERSTAND THE
UNDERSTAND OF DEVELOPING A
AFFECTIVE VACCINE.
ENHANCES EXISTING OR DEVELOPING
NEW TECHNOLOGY FOR ACHIEVING
BROAD HIV IMMUNITY IN THIS SORT
OF REFLECTS SOME OF THE EARLIER
DISCUSSIONS ABOUT
PRIORITIZATION.
THERE IS SOME INDICATION THAT
THESE DELIVERY COULD BE
BENEFICIAL AND I THINK WE NEED
TO SORT OF I GUESS, THERE WAS A
COLLECTIVE ASSESSMENT THAT WE
NEED TO DOUBLE DOWN TO
DETERMINE EXACTLY WHAT
TRANSLATION THESE STRATEGIES
MAY HOLD.
NEXT SLIDE, PLEASE.
ADVANCE UNDERSTANDING OF
INTRINSIC AND CONTROL
PROTECTIVE IMMUNE RESPONSE,
DYSFUNCTION, IMMUNE ACTIVATION
AND INFLAMMATION INCLUDING
RESPONSE TO CHRONIC HIV,
INCLUDING A I OR MACHINE
LEARNING STRATEGIES.
AND HERE'S WHERE ARTIFICIAL
STRATEGIST STARTED TO COME IN.
YOU'LL SEE IT IN MULTIPLE OTHER
OBJECTIVES AS TRYING TO
RECOGNIZE THAT HIGH DENSITY OF
DATA COULD POTENTIALLY BENEFIT
FROM INTERFACING MORE ACTIVELY.
UTILIZE THE UNDERSTANDING OF
INTRINSIC TO ENHANCE THE IMMUNE.
UNDERSTAND SUB TYPE DIFFERENCES
IN PRO POPULATION PERSON
SPECIFIC FACTORS FOR EXAMPLE,
TIMING OR TREATMENT INITIAL
TATION, MA MATERIAL AL FACTORS
AND SENSITIVITY IN INFANCY
CHILDHOOD, AFFECTING
PATHOGENSIS AND CURE STRATEGIES.
AND THIS WAS OUR ATTEMPT TO TRY
TO ENCOMPASS OUR NEED OF
UNDERSTANDING OUR BIOLOGIST
OUTSIDE THE CURRENT SUB TYPE IN
U.S. AND EUROPE AND THE
INFORMATION THAT STILL NEEDS TO
ADVANCE TO DEPLOY THE ADVANCES
ACROSS THE GLOBAL FRAMEWORK.
LASTLY, EVALUATION OF THE
IMPACT OF CURRENT THERAPIES AND
POLY PHARMACY ON IMMUNE AND
HEALTH.
THIS LAST ONE WAS THE COMMUNITY
TRYING TO HIGHLIGHT THE
PHARMACY ASPECT OF CURRENT
REJI REGIMEN.
WE'RE STARTING TO LOOK AT INTER
AXES.
INCLUDING THOSE THAT CONTRIBUTE
TO ACQUISITION, TRANSITION AND
VIRAL PERSISTENCE, AFTER
THERAPY SUCH AS OPPORTUNISTIC
INFECTIONS OR SUBSTANCE USE
DISORDER AND OTHER CAUSES OF
COMORBIDITY.
TRYING TO FOCUS ON ETOOOLOGY
REGIONAL ENVIRONMENTAL
DETERMINANTS ON COMORBID,
INCLUDING INTERACTIONS AT THE
MONTH ELECTRICLAR SUB TYPE.
THE NOVELTY WAS IS THE NEED TO
UNDERSTAND MORE REGIONAL AND
ENVIRONMENTAL DETERMINANT AS
THEY MAY IMPACT THESE CORE
AREAS THAT WE'VE BEEN INVESTING
ACROSS THIS PRIORITY.
STIMULATING TECHNOLOGY
DEVELOPMENT ON THE USE OF A I,
USE OF OUTPATIENT DATA AND
COMPUTING APPROACHES TO ADDRESS
MULTI FACT TORE AL INTERACTIONS
INCLUDING HOW HIV MAY IMPACT
PATH O GENESIS.
THIS IS THE CALL FOR MORE
INTERACTION WITH AI
INTELLIGENCE AND DATABASES
WHETHER IT'S FROM INSURANCE OR
MEDICAID OR OTHER TYPES OF
LARGE POPULATION BASE
ASSESSMENTS THAT THEY MAY
PROVIDE OPPORTUNITIES FOR
DISCOVERY REGARDING
INTERACTIONS THAT SHOULD
POTENTIALLY RECEIVE PRIORITY.
CHARACTERIZE THE MECHANISM OF
INFLAMMATION AND HIV
COMORBIDITY OR USING
GENERALEDERR AFFIRMING
THERAPIST.
INVESTIGATE THE HIV NON COMMUNE
CAL DISEASES INCLUDING,
CARDIOVASCULAR DISEASE AND
SUBSTANCE USE DISORDER AND
THEIR INTERACTIONS WITH HIV
STUDY THE FUNDAMENTAL MECHANISM
ASSOCIATED WITH CHRONIC TREATED
HIV
AND PERHAPS A--THE LAST THREE
IS REALLY TRYING TO INCOMPASS
THE BREATH OF TOPICS THAT ALL
OF THESE AREAS OF COMORBID
INTERFACE AND HOW ALL OF THEM
BECOME A PRIORITY.
THE NEXT I'LL SUMMARIZE THE
CLINICAL TASK FORCE ALTHOUGH
THIS IS ALREADY NOTED LEAD BY
TRIP--.
>> LUIS, I'M HERE.
>> OKAY, I WAS JUST FOLLOWING
THIS GUIDELINES BUT GO AHEAD.
>> NO, I'M HAPPY TO JUMPMENT
GOOD AFTERNOON, THIS IS TRIP
FROM WILD CORNELL.
I WAS PLEASE TODAY CHAIR THE
TASK FORCE.
I WANT TODAY ECHO LUIS'S THANKS
TO OARAC PROGRAM AND I WANTED
TO ACKNOWLEDGE THE TASK FORCE
MEMBERS AND FOUR OF YOU SIT ON
OARAC AND HERE TODAY.
COURTNEY FLETCHER, SLUD IMETA
AND SANTA MARIA.
THIS IS OBJECTIVITY
EPIDEMIOLOGY, COMORBIDITY AND
COMPLICATIONS WITH PEOPLE HIV
CROSS THE LIVE SPAN INCLUDING
POPULARITY POPULATIONS.
WITHIN THAT, TO DEVELOP NOVEL
APPROACHES TO EXAM DISEASE
BURDEN, DISTRIBUTION, POTENTIAL
RISK AND FACTORS IN SPECIFIC
POPULATION SXZ NATURAL HISTORY
STUDIES TO OBSERVE TRANSMISSION
DYNAMICS AND PATTERNS TRENDS IN
THE PREVENTION AND TREATMENT
CASCADES, EARLY STAGES OF
INFECTION AND PROGRESSION OF
HIV AND COMORBIDITY AND
COMPLICATIONS IN BOTH DOMESTIC
AND INTERNATIONAL SETTINGS TO
GUIDE PREVENTION AND TREATMENT
STRATEGIES AND OUR SPECIFIC
RECOMMENDATIONS FOR THIS
OBJECTIVES, THE PRIORITIES THAT
WE WERE TO IDENTIFY, WAS TO
DEVELOP NOVEL APPROACHES TO
UNDERSTAND HIV BURDEN,
DISTRIBUTION AND POTENTIAL RISK
AND PROTECTIVE FACTORS
INCLUDING THOSE THAT INFLUENCE
HIV TRANSMISSION, VIRAL
RESERVOIRS AND DISEASE
PROGRESSION IN PEOPLE WITH HIV
SECONDLY TO INCORPORATE ADVANCE
EPIOLOGY TO MONITORING OF
INDENSE AND TO IDENTIFY
HOTSPOTS AND TRENDS.
ALSO TO CONDUCT LONGITUDINAL
ASSESSMENTS OF PEOPLE AT-RISK
OR WITH HIV INCLUDING
SUPPORTING COHORT STUDIES TO
OBSERVE THE INCIDENTS AND
COURSE OF HIV FOCUSING ON
PHYSIOLOGICAL CELLULAR, BIO
CHEMICAL AND STRUCTURAL AND
BEHAVIORAL FACTORS IN BOTH
DOMESTIC AND INTERNATIONAL
SETTINGS TO GUIDE PREVENTION
AND TREATMENT STRATEGIES.
FOURTHLY TO CONDUCT STUDIES TO
BETTER UNDERSTAND THE IMPACT,
BURDEN, DISTRIBUTION, RISK
FACTORS AND DISEASE PROGRESSION
ASSOCIATED WITH COINFECTIONS,
CORE MORBIDITY AND SIN
--SYNDEMIC.
AND FINALLY TO CONDUCT STUDIES
TO ASSESS THE AGING WITH PEOPLE
LIVING WITH HIV INCLUDING
CLINICAL, SOCIAL AND STRUCTURAL
OUTCOMES.
IF WE GO TO THE NEXT SLIDE,
I'LL TURN IT OVER TO OMAR.
>> THANK YOU.
OBJECTIVE 1.4 IS ABOUT
PROCESSES.
THE TASK FORCE RECOMMENDATIONS
FOR PRIORITIES IS SPECIFICALLY
WHERE STUDIES THE CAUSAL
PATHWAYS OF SOCIAL DETERMINISM,
FOR EXAMPLE, SYSTEMIC RACISM,
POLITICAL CLIMATE, ECONOMIC,
HOUSING INSECURITY AS WELL AS
STRUCTURAL VIOLENCE.
ON THE RISK OF HIV ACQUISITION
AND HIV OUTCOMES TO AID IN THE
DEVELOPMENT OF AFFECTIVE AND
EQUITABLE PREVENTION AND CURE
INTERVENTIONS.
THE NEXT ITEM WAS RESEARCHING
THE ASSOCIATIONS AMONG AND
IMPACT OF COOCCURING INCLUDING
MENTAL HEALTH AND SUBSTANCE USE
AND RESILIENCE WITH RESPECT TO
HIV TRANSMISSION DISEASE
PROGRESSION CARE AND CURE.
THE NEXT ITEM WAS ELUCIDATING
STRUCTURAL STRUCTURE UNDER
DIFFERENTIAL OUTCOMES
SPECIFICALLY THOSE AFFECTED BY
HIV IN DIVERSE SETTINGS.
NEXT.
WE'RE BACK TO--GOAL 2.
>> SO GOAL 2 IS TO ADVANCE THE
DEVELOPMENT OF ASSESSMENT OF
NOVEL INTERVENTIONS FOR HIV
PREVENTION.
KNOWLEDGE FROM FUNDAMENTAL IN
FORMS CLINICAL TRIALS AND OTHER
INTERVENTION STUDIES THAT TEST
THE MOST PROMISING TOOLS OR
PRODUCT FOR HIV PREVENT,
TREATMENT AND CURE FOR HIV
RIGOROUS CONTROL TRIALS
OBSERVATION AL STUDIES AND
OTHER METHODOLOGY BY SOCIAL
OUTCOMES OF NOVEL INTERVENTION
SXZ THEIR VISIBILITY AND
EFFECTIVENESS IN DIVERSE
POPULATIONS AND ACROSS THE LIFE
SPAN.
SO THIS GOAL REALLY INTERFACES
THREE OBJECTIVES.
THE FIRST ONE WAS TACKLED BY
THE TASK FORCE.
NEXT SLIDE.
AND IT REALLY ADDRESSES THE
PRECLINICAL AND TRANSLATIONAL
RESEARCH SPACE IN THIS
PARTICULAR GOAL.
TRYING TO SUPPORT PRECLINICAL
STUDIES TO DEVELOP, EVALUATE
AND VALIDATE AND OP MIEZ THE
BIOMEDICAL RESEARCH DISCOVERIES
OF AGENTS, TARGETS AND
STRATEGIES TO BE TESTED FOR HIV
TREATMENT AND CORE MORBIDITY
AND CURE.
THE SPECIFIC RECOMMENDATION WAS
TO EMPHASIZE THE STUDY, THE
INTERACTIONS BETWEEN HIV AND
WHOLE CELLS TO IDENTIFY NEW
THERAPEUTIC TARGETS.
WE HEARD EARLIER ADDITIONAL
AREAS THAT REMAIN TO BE
ADVANCED FOR EXAMPLE.
NEXT TEST CANDIDATES INCLUDING
DRUGS DELIVERY SYSTEMS, VACCINE
AND CURE STRATEGIES.
WHICH ARE OBVIOUSLY, A CENTRAL
COME POENT--COMPONENT OF OUR ON
GOING EFFORT.
ARTIFICIAL INTELLIGENCE AND
PREDICT I HAVE MODELS TO
FORECAST TREATMENT OUTCOMES AND
THERAPEUTIC RESPONSE AND TO
INFORM CURE STRATEGIES.
ENHANCE EXISTING AND DEVELOP
NEW PRECLINICAL MODELS AND USE
OF CLINICAL RESOURCES TO STUDY
HIV PERSISTENT RESERVOIR
DYNAMIC, REPLICATION, ANTI
VIRAL STRATEGIES AND ART AND
SPREAD COINFECTIOUS AND OTHER
SUCH AS SUBSTANCE USE DISORDER.
AND THIS IS AN AREA THAT DREW A
LOT OF DISCUSSION ABOUT THE
NEED TO REALLY TRY TO MAXIMIZE
THE POTENTIAL OF NO HE WILL
PRECLINICAL MODELS WHETHER IT
ANIMAL OF PRIMATE OR HUMANIZED
MICE.
ELUCIDATE FACTORS THAT INFORM
DIAGNOSIS OF TREATMENT OF WOMEN
AND GIRLS LIVING WITH HIV
ACROSS LIFESTYLE, INCLUDING SEX
DIFFERENCES AND ARV.
NEXT SLIDE.
IMPLEMENT TRANSLATIONAL
RESEARCH INITIATIVE TO OPTIMIZE
HIV TREATMENT AND STRATEGIES
FOR DIVERSE POPULATIONS
BRIDGING THE GAP BETWEEN BASIC
RESEARCH AND APPLICATION TO SEE
BRING NEW TREATMENT AND
PREVENTIVE MEASURES TO PATIENTS.
AND IMPLEMENT AND SUSTAIN
PROGRAMS FOR ALL PHASES OF
CLINICAL DEVELOPMENT FOR CURE
DIRECT STRATEGIES INCLUDING
PROCESS AND G.M. P AND CLINICAL
PRODUCTION AND FORMULATION, AND
ASSOCIATED TASK LEADING TO THE
FILING OF INVESTIGATION ON NEW
DRUG APPLICATIONS AND THIS ALSO
DREW A LOT OF DISCUSSION ABOUT
TRYING TO BRIDGE THAT VALUE OF
DEATH, THAT COMPONENT OF
ACADEMIC DEVELOPMENT THAT
THEY'VE BEEN TRYING TO BRIDGE
THROUGH APPLICATION, ON GOING
INITIATIVES IN THIS REGARD AND
I THINK THAT MORE OF THAT WAS
VIEWED TO BE A PRIORITY MOVING
FORWARD.
AND WE TRANSITION NOW TO TRIP
ON CLINICAL.
>> RIGHT, SO CLINICAL TASK
FORCE TOOK ON THE NEXT TWO
OBJECTIVES.
THE ONE YOU SEE HERE, RESEARCH,
TRIALS AND OTHER INTERVENTION
STUDIES OF HIV PREVENTION
INCLUDING VACCINES, TREATMENT
COMORBIDITY WITH PEOPLE AT-RISK
INCLUDING UNDER STUDIED AND
PRIORITY POPULATIONS, MORE
SPECIFICALLY TO CONDUCT
CLINICAL RESEARCH INCLUDING ALL
THE WAY FROM FIRST IN HUMAN TO
PHASE 4 TRIALS TO ASSESS THE
SAFETY, ETHICACY AND ADHERENCE
TO HIV PREVENTION, TREATMENT,
CORE MORBIDITY AND METHODS
INCLUDING THOSE CONNECTED TO
VACCINE TREATMENT AND CURE,
EITHER USED ALONE OR IN
COMBINATION TO REDUCE THE
REDUCTION OF HIV AND RELATED
SEXUALLY TRANSMITTED DISEASES,
UNINTENDED PREGNANCY AS WELL AS
VIRAL RESERVOIR AND OTHER
ADVERSE EVENTS.
O OUR SPECIFIC RECOMMENDATION
START TO CONDUCT FIRST IN HUMAN
PHASE 4 CLINICAL STUDIES TO
ACCELERATE EVALUATION OF SAFETY
ETHICACY AND OPTIMAL DOSING AND
ADHERENCE IN THE FOLLOWING
BROAD AREAS.
NUMBER 1, HIV PREVENTION
INCLUDING ANTI RETRI VIRAL
VACCINE AND IMMUNE BASE
PREVENTION MULTI PURPOSE
PREVENTION TECHNOLOGIES AND
OTHER INNOVATIONS FOR PEOPLE
WHO ARE AT-RISK FOR HIV
SECONDLY, IS THE THERAPEUTIC
NEW AND NOVEL THERAPEUTIC
INTERVENTION SXZ ITS ASSOCIATED
COINFECTIONS, COMORBIDITY AND
SIN DEMIC CONDITIONS WITH
PEOPLE WITH HIV
THIRDLY HIV CURE AND REVISION
STRATEGIES FOR PEOPLE WITH HIV,
NEXT SLIDE.
AND AND LONG TERM SIDE AFFECTS
AND CURE INTERVENTIONS THROUGH
EXTENDED FOLLOW-UP STUDIES.
TO INVESTIGATE CAUSAL MODELING
AND AFFECTIVE OF INTERVENTIONS
AIMED AT IMPROVING OUTCOMES
WHILE ALSO REDUCING STIGMA AND
IMPROVING MENTAL HEALTH, USING
REAL WORLD DATA REFLECTING THE
COMPLEXITIES.
AND FINALLY, UNDER THE
OBJECTIVE TO ADAPT AND A TAR
EVIDENCE BASE INTERVENTIONS
INCLUDING BEHAVIORAL SOCIAL AND
STRUCTURAL INTERVENTIONS TO
MEET THE SPECIFIC NEEDS OF
PEOPLE AT-RISK OR WITH HIV IN
DIVERSE AND UNDER STUDIED
STUDIES.
NEXT.
IS OBJECTIVE 2.3 AND THIS IS
FOCUSING REALLY ON MODELS OF
CARE TO DEVELOP AND EVALUATE
AND INNOVATIVE AND INTEGRATED
MODELS OF CARE AND SERVICES FOR
HIV TREATMENT, PREVENTION CARE
AND HIV COMPLICATION SXZ
COMORBIDITY AND COINFECTIONS
BOTH IN PEOPLE AT-RISK OR ARE
HIV INCLUDING UNDER STUDIED AND
PRIORITY POPULATIONS.
AND MORE SPECIFIC TO DEVELOP
AND EVALUATE THE ETHICACY OF
INTEGRATED MODELS THAT COMBINED
BIO MEDICAL AND BEHAVIORAL AND
SOCIAL SCIENCE APPROACHES TO
HIV CARE, SUPPORT AS WELL AS
CURE RESEARCH AND SERVICES.
TO PROMOTE ASSESSMENT OF NOVEL
STRATEGIES USING NEW TECHNOLOGY
FOR EXAMPLE, TELE MEDICINE AND
THE USE OF NON CLINICAL SETTING
SUCH AS COMMUNITY BASE
ORGANIZATION TO DELIVER HIV
SERVICES.
LE ALSO TO INVESTIGATE THE
POTENTIAL OF INTEGRATED HIV
BEHAVIORAL HEALTH AND OTHER
CHRONIC AND NON COMMUNICABLE
DISEASE SERVICES.
AND TO DEVELOP AN EVALUATE
PERSON CENTER AND
COMMUNITY-LEAD SERVICE MODELS.
AND UNDER THAT OBJECTIVE, WE
HAD SPECIFIC RECOMMENDATIONS
FOR PRIORITY TO DEVELOP AND
ASSESS THE EFFECTIVENESS OF
PREVENTION AND TREATMENT
DELIVERY MODELS THAT INTEGRATE
BIO MEDICAL BEHAVIORAL AND
STRUCTURAL INTERVENTIONS TO
REDUCE HIV INCIDENTS WITH
PEOPLE AT-RISK WITH HIV
AND TO IMPROVE TREATMENT AND
IMPROVE COMORBIDITY OUTCOMES IN
PEOPLE LIVING WITH HIV
SECONDLY TO DEVELOP AND
EVALUATE COME PREHENCE,
INNOVATIVE PATIENT CENTERED OR
PERSON CENTERED, I SHOULD SAY,
CARE MODELS THAT INTEGRATE HIV
PREVENTION AND TREATMENT WITH
OTHER SERVICES AND SETTINGS
THROUGH PARTNERSHIPS WITH OTHER
GROUPS TO MANAGE COINFECTIONS,
COMORBIDITIES, COMPLICATIONS
AND SIN DIMIC CONDITIONS WITH
PEOPLE WITH HIV
NEXT.
TO DEVELOP AND EVALUATE THE
EFFECTIVE OF NOVEL STRATEGIES
PREVENTION AND TREATMENT
SERVICE DELIVERY, TO EXPLORE
AND EVALUATE CLINICAL AND
COMMUNITY BASE SERVICE DELIVERY
MODELS, TO ENHANCE STAINABLE
PROGRAMMING, COMMUNITY
ENGAGEMENT AND RETENTION IN
PREVENTION AND CARE AND FINALLY
TO LEVERAGE RESEARCH MODELS
THAT ASSESS THE IMPACT OF
SOCIAL AND STRUCTURAL
DETERMINANTS OF HEALTH AND
LOCAL STATE AND FEDERAL AND
GLOBAL POLICIES ON THE HEALTH
OF PEOPLE LIVING WITH AND
AFFECTED BY HIV IN DIVERSE AND
UNDER STUDIED SETTINGS.
NEXT SLIDE.
I THINK THIS IS OMAR.
>> YES, SO THIS IS GOAL 3 AND
THE GOAL HERE IS OPTIMIZING
PUBLIC HEALTH IMPACT OF HIV
DISCOVERY THROUGH DIS SEM
NATION OF MINDINGS.
IT WAS REALLY INTERESTING TO
HEAR THE PRESENTATIONS EARLIER
AND REALIZE IT HAS TAKEN 30
YEARS SINCE THE INITIAL THE
BASIC SCIENCE.
HOW DO WE BECOME MORE EFFICIENT
AT DOING THIS.
SO THE SPECIFIC OBJECTIVES ARE
3.1 ENHANCING IMPLEMENTATION
SCIENCE 3.2 PROMOTING RESEARCH
AND OBJECTIVE 3.3 IMPROVING DID
I SIM NATION THROUGH
COMMUNICATION RESEARCH.
NEXT.
SO THE LEMATION FOR OBJECTIVE
3.1 IN TERMS OF ENHANCING
IMPLEMENTATION SCIENCE ARE
FIRST, CONDUCTING
IMPLEMENTATION RESEARCH TO OP
MIEZ--OPTIMIZE THE REAL WORLD
ACTIVITY IN MULTIPLE SITES AND
SETTINGS.
THEN TO EVALUATE THE SCALE
ABILITY AND SUSTAINABILITY OF
EVIDENCE HIV INTERVENTION
MODELS IN DIVERSE POPULATION
SXZ SETTINGS INCLUDING RESEARCH
LIMITED SETTINGS.
THEN WE HAVE IDENTIFYING AND
ADDRESSING FACTORS AFFECTING
INTERVENTION, AND
SUSTAINABILITY TO PROMOTE
EQUITABLE UP TAKE AND IMPACT OF
HIV INTERVENTIONS.
THEN WE HAVE DEVELOPING AND
EVALUATE HEALTH SYSTEM
INTERVENTIONS THAT SUPPORT THE
COMPREHENSIVE HIV AS WELL AS TO
STRENGTHEN SERVICE DELIVERY
SUPPLY CHAIN MANAGEMENT ET
CETERA.
NEXT, STUDYING THE IMPACT OF
LOCAL STATE AND FEDERAL
POLICIES FOR EXAMPLE, HIV
CRIMINALIZATION LAWS, ANTI
TRANSGENDER, ANTI ABORTION AND
OTHER POLICIES AND REGULATORY
ENVIRONMENT ON IMPLEMENT OF HIV
AND CURE INTERVENTION TO
ADDRESS THE STRUCTURAL
IMPLEMENTATION BARRIERS.
DEVELOPING AND UTILIZING
IMPLEMENTATION SCIENCE FRAME
WORKEDS TO GUIDE DATA
COLLECTION AND SCIENCE AND
APPLICATION IN REAL LIFE
SETTINGS SUSTAINABILITY OF
INTERVENTION IN COMMUNITIES
DISPROPORTIONATE LEA
FEBRUARIEDING BY HIV
NEXT.
OBJECTIVE 3.2, IT'S ABOUT
PROMOTING COMMUNITY ENGAGE AND
COMMUNITY LEAD HIV RESEARCH.
THIS SPECIFIC RECOMMENDATIONS
AND THIS IS ALREADY INCLUDING
ALL OF THE TASK FORCES,
INCLUDES ENGAGING PERSON'S
LIVING WITH HIV ADVOCATE AND
PARTNERS NATIONALLY AND
GLOBALLY IN FULL RESEARCH
PROCESS.
FOR EXAMPLE, RESEARCH
QUESTIONS, STUDY DESIGN,
PROJECT RECOMMENDATION TO
ENSURE CULTURAL RELEVANCE AND
ACCEPTANCE INCLUDING THROUGH
THE USE OF COMMUNITY BASE
RESEARCH METHODS.
THEN WE HAVE DEVELOPED AND
EVALUATE COMMUNITY LEAD
INTERVENTION.
INCLUDING THOSE FOCUSED ON
ASSOCIATED INTERSECTIONAL
DISCRIMINATION AS WELL AS
MENTAL HEALTH AND SUBSTANCE
YOUTH.
AND WE ALSO HAVE SUPPORT,
COMMUNITY AND EDUCATION
STRATEGIES AND PUBLIC HEALTH
CAMPAIGNS.
COMMUNITY LEAD INTERVENTION
INCLUDING MONITORING AND
EVALUATE IN XLES DM*ES
--DOMESTIC SETTINGS.
HIV-RELATED OUTCOME INCLUDING
THROUGH ESTABLISHED NETWORK
ALREADY SERVING THE MOST
AFFECTED COMMUNITIES, AND
INSTITUTIONS WITH CLINICAL
TRANSLATIONAL SCIENCE CTSIs
RESEARCH, SUCH THAT HIV
RESEARCH AND INTERVENTION
DEVELOPED MEET THE NEEDS OF ALL
PEOPLE, IMPACTED BY HIV
SUPPORT SUSTAINABLE OF LONG
TERM RESEARCH EN DERING
INCLUDING THOSE INVOLVING YOUTH
AND THE NEXT GENERATION OF
COMMUNITY REPRESENTATIVES AND
SUPPORT RECOGNITION OF LIVED
EXPERIENCE IN HIV RESEARCH.
NEXT.
DEVELOPING AND IMPLEMENT AND
VALUE ATE INNOVATIVE TAYLOR
COMMUNICATION STRATEGY TO
TRANSLATE AND CLEARLY CONVEY
COMPLEX INFORMATION RELATED
RESEARCH FINDINGS TO DIVERSE
AUDIENCES.
THEN, TRAIN RESEARCHERS AND
COMMUNITY BASE ORGANIZATION ON
AFFECTIVE SCIENCE COMMUNICATION
TECHNIQUES INCLUDING THOSE
ADDRESSING THIS, ACCURATE
RESEARCH FINDINGS THROUGH
VARIOUS OUTLETS.
DEVELOP AFFECTIVE FRAME WORKS
AND PARTNERSHIPS BETWEEN
RESEARCH AND COMMUNITY MEMBERS
TO TRANSLATE RESEARCH FINDINGS
INTO ACTIONABLE PROGRAMS AND
POLICIES.
AND USE PRACTICES SUCH AS
COMMUNITY BASE RESEARCH TO
ENSURE THAT THE DID
DISSEMINATE, AND INFORM
DECISION MAKING.
NEXT.
>> SOING THIS IS ME AGAIN.
GOAL NUMBER 4 IS THE CAPACITY
GOAL.
OVERALL TO BUILD RESEARCH
WORKFORCE AND INFRASTRUCTURE
CAPACITY TO ENHANCE SUSTAINABLE
OF HIV DISCOVERY.
AND THE THOUGHTS HERE, AND ITS
APPLICATION REQUIRES ROBUST
SUPPORT FOR RESEARCH TOOLS AND
INSTRUMENTATION, METHODS
RESOURCES DATA AND WORKFORCE
DEVELOPMENT.
PARTICULARLY IN INSTITUTION
THAT'S SERVE UNDER REPRESENTED
OR HIGH HIV BURDEN POPULATIONS
OR HISTORICALLY BEING UNDER
FUNDED IN U.S. AND GLOBAL'.
SUCH ENHANCE EFFORTS WILL
PROMOTE DIVERSITY AND INCLUSION
IN THE HIV RESEARCH WORKFORCE.
THAT'S THE OVERALL GLOBALSINGER
THE THREE OBJECTIVES TO EXPAND,
WORKFORCE CAPACITY, STRENGTHEN
RESEARCH INFRASTRUCTURE AND
CAPACITY AND FINALLY TO ENHANCE
METHODS AND TECHNOLOGIES.
NEXT, SO AGAIN THIS IS A SHARED
OBJECTIVE, AMONG THE THREE
GROUPS, THE THREE TASK FORCES
TO CONSIDER EXPANDING WORKFORCE
CAPACITY.
THAT IS TRAINING AND MENTORING
ACTIVITIES TO SUPPORT CAREER
DEVELOPMENT AND STRENGTHEN THE
CAPACITY OF BIOMEDICAL,
BEHAVIORAL SOCIAL AND COMMUNITY
BASE HIV RESEARCHERS IN DIVERSE
SETTINGS AND INSTITUTIONS.
AND TO PROMOTE ACTIVITIES TO
INKRESS, ENHANCE AND SUSTAIN
DIVERSITY IN THE HIV WORKFORCE
IN THE U.S. AND GLOBALLY.
THIS SPECIFIC RECOMMENDATION
SXZ AGAIN, THESE ARE SHARED
BETWEEN THE THREE TASK FORCES,
TO DEVELOP COMPREHENSIVE INTER
DISCIPLINARY TRAINING PROGRAMS
THAT INCLUDE THE LATEST
BIOMEDICAL, BIOBEHAVIORAL AND
SOCIAL SCIENCE RESEARCH METH
YTHOLOGIES TO ENHANCE SKILL AND
KNOWLEDGE OF THE RESEARCH.
NEXT TO IMPLEMENT STRUCTURE AND
SUSTAINED MENTORSHIP
INITIATIVES TO SUPPORT EARLY
AND MID-CAREER HIV RESEARCHERS,
INVESTIGATES NEW TO HIV
RESEARCH AND COMMUNITY REPS IN
DIVERSE SETTINGS AND USING
DIVERSE METHODSES TO ENSURE
EXPANSION OF THE NEXT
GENERATION OF HIV WORKFORCE.
ALSO TO SUPPORT CAREER
DEVELOPMENT TO LONGITUDE THAT
PROVIDE FUNDING SKILLS BUILDING
MENTORSHIP AND LEADERSHIP
OPPORTUNITIES TO FACILITATE
TRANSITIONS FROM TRAINEE TO
INDEPENDENT RESEARCH.
RESEARCHER, AND FINALLY TO
DEVELOP AND IMPLEMENT
COMPREHENSIVE AND SUSTAINED
INITIATIVE TO INCREASE AND SUS
STAINT REPRESENTATION OF WOMEN,
RAISH I CAN'T AND ETHNIC
MINORITIES AND OTHER UNDER
REPRESENTED GROUPS IN THE HIV
WORKFORCE.
NEXT.
THREE OTHERS, ESTABLISH AND
EXPAND GLOBAL TRAINING NETWORKS
TO ENHANCE CAPACITY BUILDING,
SHARED KNOWLEDGE AND PROMOTE
CAREER DEVELOPMENT AND BEST
PRACTICES ACROSS DIFFERENT
SETTINGS, STRENGTHEN
PARTNERSHIPS BETWEEN ACADEMIC
INSTITUTIONS, HEALTHCARE
ORGANIZATION SXZ COMMUNITY BASE
ORGANIZATION TO SEE ENHANCE
RESEARCH TRAIN ANDING CAREER
DEVELOPMENT AND FINALLY, TO
SUPPORT RESEARCH LITERACY
PROGRAMS AND PROMOTE
COOPERATION AMONG MEDICAL
SCIENCE TRAINEE GROUPS.
NEXT.
>> NEXT IS ANOTHER SHARED
OBJECTIVE 4.2 STRENGTHEN THE
INFRASTRUCTURE AND CAPACITY.
TO ENABLE AND SUPPORT
STATE-OF-THE-ART SCIENCE AND
AFFECTIVE DATA MANAGEMENT
ACCESSIBILITY AND ANALYSIS.
ENSURE ACCESS TO RESOURCES AND
COHORTS FOR CONDUCTING
FUNDAMENTAL AND PRECLINICAL AND
OTHER INTERVENTION AL RESEARCH
INCLUDING CLINICAL TRIALS IN
DOMESTIC AND INTERNATIONAL
SITES AND IMPLEMENTATION
STUDIES SCIENTIFIC ENVIRONMENT
TO MEET TODAY'S CHALLENGES AND
OPPORTUNITIES IN HIV RESEARCH.
THE SPECIFIC RECOMMENDATIONS
WERE TO IMPROVE AND EXPAND
RESEARCH AND ANIMAL BREEDING
FACILITIES TO SUPPORT HIV
RESEARCH AND AGAIN THROUGH A
LOT OF DISCUSSION ABOUT THE
LIMITS OF OUR CURRENT
INFRASTRUCTURE WHEN IT COMES TO
AVAILABLE NON HUMAN
PRIMATEDSMENT NEXT IS INVEST IN
THE UPGRADE AND EXPANSION OF
ADVANCE LABORATORY
INFRASTRUCTURE AND ENSURE
EQUITABLE AND DIVERSE ACCESS TO
THESE AND EQUIPMENT AND
TECHNOLOGY TO SUPPORT CUTTING
EDGE HIV RESEARCH NATIONALLY
AND GLOBALLY.
SUSTAIN AND EXPAND
INFRASTRUCTURE INCLUDING
CLINICAL TRIAL SITES AND
RECRUITMENT SYSTEMS AND
REGULATORY SUPPORT.
IMPLEMENT AND SUSTAIN THAT A
MANAGEMENT SYSTEM THAT
FACILITATE THAT SHARING AND
COOPERATION AMONG RESEARCHER
AND ENHANCE IMPLEMENTATION AND
CARE.
ACADEMIC INDUSTRY PARTNERSHIP
TO FOSTER A I TECHNOLOGY.
AND THIS IS ANOTHER TOPIC AS
DISCUSSED EARLIER TODAY, THERE
IS GOOD THINGS ACADEMIA DOES
AND INDUSTRY DOES AND WE NEED
TO BRIDGE THE MAGNITUDE OF THE
INDUSTRY CAPACITY IN MORE
INNOVATIVE PARTNERSHIPS MOVING
FORWARD.
NEXT SLIDE.
ENHANCE SUPPORT FOR REGULATORY
SUPPORT AND PRODUCT PRODUCTION
FOR ACADEMIC AND STUDIES, THIS
IS SOMEWHAT ANOTHER STRESS
POINT THAT WE THOUGHT IN
EARLIER RECOMMENDATIONS.
ENSURE DEVELOP AND SUPPORT
COLLABORATIVE RESEARCH NETWORKS
TO FACILITATE SHARING AND MULTI
SITE STUDIES BY PROMOTING
DIRECTIONS BETWEEN CLINICAL
CENTERS AND PHILANTHROPIC
INDUSTRIES AND THIS IS ANOTHER
POINT THAT YOU ARE ALL
DISCUSSION TRYING TO TAP INTO
EXISTING NETWORKS.
ENHANCE OR DEVELOP RESEARCH
INFRASTRUCTURE TARGETING
SPECIFIC LEVELS OF EDGE FUND TO
GO ENHANCE GREATER WORKFORCE
DIVERSITY.
AND ENHANCE FULT MULTI
INVESTIGATOR RESOURCE BY ADDED
CONTRACT STRATEGIES DO
INTRODUCE CONSUMABLE AND
EXPANSION OF TISSUE DEPOSITORY
AND AGAIN THROUGH A LOT OF
DISCUSSION TRYING TO I GUESS,
FOSTER THAT THESE AGENT REPOS
TORIES CAN BE EXPAND ED TO
EXPRESS COMMON THAT
INVESTIGATORS USE AS FAR AS
INTER LOOKING TOO AND THINGS
THAT ARE KIND OF IN MOST
PEOPLE'S CONSUMABLE BUCKETS.
NEXT SLIDE.
REGARDING THE OBJECTIVE 4.3
ENHANCE METHODS AND TECHNOLOGY.
THIS IS AN OBJECTIVE THAT LOOKS
TO FURTHER DEVELOP AND OP MIEZ
CRITICAL METHODS SUCH AS
INSTRUMENTAL AND SOFTWARE AND
IMAGING, BIOENGINEERING, INFO
MATICS, BIOMARKERS FOR DID I
VERSE PROGRESSIVE AND
TREATMENT, NEW COMMUNICATION
AND SOCIAL MEDIA TECHNOLOGIES,
ARTIFICIAL INTELLIGENCE AND
NATURAL LANGUAGE FOR TREATMENT
AND CURE.
THE PRIORITIES WERE TO INVEST
INSTRUMENTAL AND TECHNOLOGY
INCLUDING ADVANCE IMAGING AND
SAMPLING TECHNOLOGY TO ENABLE
HIGH-QUALITY TRANSLATIONAL
BIOMEDICAL AND SOCIAL SCIENCE
RESEARCH.
ENHANCE COMPUTATIONAL RESOURCES
PATIENT OUTCOME DATA SETS AND
MODELING IN SUPPORT OF LARGE
SCALE HIV RESEARCH.
INVEST AND DEVELOPING DEPLOYING
TECHNOLOGIES AND SYSTEMS THAT
FACILITATE IMPLEMENTATION OF
NEW AND PREVENTION TREATMENT
INCLUDING HIV STATUS TESTING,
MONITORING AND ADHERENCE
TESTING INCLUDING AT POINT OF
CARE AND SELF HOME MONITORING.
NEXT SLIDE.
NEXT TWO OBJECTIVES WERE
LETHBRIDGE EQUITABLE USE OF
ARTIFICIAL INTELLIGENCE AND
NATURAL LANGUAGE PROCESSING AND
MACHINE LEARNING TECHNOLOGY TO
ANALYZE LARGE AND IDENTIFY
PATTERNS OF HIV PROGRESSION AND
EN PANS INCLUDING PREDICT I
HAVE MODELING AND DATA ANALYSIS.
AND LASTLY DEVELOP AND
IMPLEMENT AND SUSTAIN NEW
COMMUNITIES FOR DID I DID DIS
SEM NATION.
THIS WAS DREW A LO INVEST IN
MARKETING, EDUCATING BOTH
CLINICAL AND LATE COMMUNITIES
ABOUT THE NEED TO INTERFACE AND
COLLABORATE IN BASIC RESEARCH
INITIATIVE WHICH WAS A NOVEL
CAPACITY FROM A POINT OF VIEW
OF OUR WORDS.
I THINK THAT CONCLUDES OUR
DISCUSSION, THANK YOU.
>> THANK YOU SO MUCH.
THANK YOU SO DR.S BONSAL,
MONANER AND GALICK, NOW WE HAVE
TIME FOR DISCUSSION.
IF YOU HAVE ANY QUESTIONS OR
COMMENTS, PLEASE RAISE YOUR
HAND.
YES, DR. DONENBERG, YOU HAVE TO
UNMUTE YOURSELF.
>> THANK YOU, FIRST I WANT TO
THANK THE TASK FORCES, SO MUCH
WORK WENT INTO THOSE
RECOMMENDATION SXZ KUDOS TO YOU.
I THINK MY QUESTION AND MAYBE
WITH MY HAT ON AS OAR DIRECTOR,
THERE WERE A LOT OF
DATIONS.
ACROSS ALL OF THAT AND OF
COURSE, WHILE EVERY SINGLE ONE
OF THEM IS IMPORTANT AND
CERTAIN WELL JUSTIFIED GIVEN THE
THIS PHASE OF THE EPIDEMIC, MY
SUGGESTION WOULD BE TO PRIOR
TICE AND MAYBE THE TASK FORCES
OR OARAC TO SAY WHICH OF ALL OF
THESE RECOMMENDATIONS ARE THE
ONES THAT SHOULD RISE FOR THE
TOP FOR FUNDING AT THIS STAGE?
AND I THINK WE'VE HEARD VERY
COMPELLING JUSTIFICATION FOR
WHY BASIC SCIENCE IS VERY
IMPORTANT.
WE HEARD JUSTIFICATION FOR
INFRASTRUCTURE AND CAPACITY
BUILDING.
SO I'M INTERESTED IN HEARING
FROM THE TASK FORCE LEADERS AND
OARAC MEMBERS WHAT PROCESS
WOULD YOU GO THROUGH TO
IDENTIFY THE PRIORITIES TO
MATCH WITH FUN
UNITIES?
THANK YOU.
>> THANK YOU, DOCTOR.
I'LL START BUT I WANT TO
CLARIFY THAT OUR CHARTS FOR THE
TASK FORCES WAS TO ENUMERATE 5
TO 6 PRIORITIES AND WE WERE
SPECIFICALLY INSTRUCTED NOT TO
RANK THEM.
THERE WERE MEMBERS OF OUR TASK
FORCE THAT'S ASKED A SIMILAR
QUESTION AS YOU'RE RAISING.
WE'RE PRETTY MUCH BEING SO
INCLUSIVE THAT WE'RE NOT
PRIORITIZING ANY ONE AREA THAN
ANOTHER.
SO IT WOULD REPRESENT A
DIFFERENT EXERCISE IN WHAT WE
UNDERTOOK CAUSE WE WERE MORE
FOCUSED ON BEING INCLUSIVE OVER
OUR CURRENT EFFORTS BUT ADDING
COMPONENTS THAT WERE AS
EMPHASIZED FOR EXAMPLE,
ARTIFICIAL INTELLIGENCE, PRIET
AT RESOURCES THINGS THAT WE
THOUGHT AND PERHAPS I'M BEING
BIASED BECAUSE, I'M HAOUR TRIP
AND OTHERS WILL HAVE OTHER
TOPIC.
BUT YOU'RE RAISING A REALLY
IMPORTANT QUESTION BUT IT WOULD
BE US RANKING THEM HERE, AS FAR
AS HOW WE WOULD RANK THEM BUT
THAT'S NOT THE WHAT TASK FORCE
WAS REQUESTED TO REPORT.
>> YEAH, I'LL JUMP IN AFTER
LUIS AND ECHO THAT.
WE WERE SPECIFICALLY NOT
THINKING ABOUT RANKING THEM IN
TERMS OF PRIORITY.
AND JUST TO POINT OUT HOW
DIFFICULT THAT WOULD BE,
BECAUSE WE WERE DIVIDE INTO
THREE TASK FORCES BASED ON OUR
EXPERTISE AND OF COURSE ALONG
WITH EXPERTISE COMES OUR
EXPERIENCE AND IMPORTANTLY, THE
AREAS WE'RE WORKING IN NOW AND
ALTHOUGH WE ALL LIKE TO BE
OBJECTIVE AND LOOK AT THE BIG
PICTURE, TIME AND TIME AGAIN,
WE WERE FACED WITH ADVOCATING
FOR OUR OWN AREAS OF INTEREST.
, PARTICULARLY WHEN WH
DIVIDE US INTO THREE GROUPS,
BASIC CLINICAL AND SOCIAL
SCIENCE AND BEHAVIORAL.
SO THAT REINFORCED THE IDEA
THAT WE WERE GOING TO LOOK AT
OUR OWN AREAS AND TRY TO COME
WUP THE TOP PRIORITIES WITHOUT
RANKING THEM.
BUT I WOULD THINK THAT YOU
WOULD NEED A GROUP OF
INDIVIDUALS WHO AGREED TO LEAVE
BIAS SXZ PERSONAL INTEREST AT
THE DOOR AND TAKE A LOOK AT THE
BIG PICTURE, BECAUSE I THINK
JUST TO STATE THE OBVIOUS, THAT
WE APPRECIATE ALL THREE AREAS
AND WHAT THEY'VE CONTRIBUTED
AND WE'RE ONLY HERE TODAY
BECAUSE WE INVESTED IN ALL OF
THREE OF THOSE AREAS.
OMAR, YOU GET THE LAST WORD
FROM THE TASK FORCE GUYS.
>> THANK YOU.
>> THANK YOU, I THINK WE
STRUGGLED AS A HEALTH ECONOMIST.
I WENT IN SAYING, WELL WE NEED
TO RANK ORDER THIS AND THERE
ARE METHODS, WE CAN USE DELTA
METH OR EXPERIMENTS THAT'S MY
AREA OF EXPERTISE AND THAT'S
HOW WE HAVE PREFERENCE AND WHAT
WE HAVE HERE IS A CONSTITUENCY
AND WE HAVE TO MAP THE
PREFERENCES, I WAS LIKE, THIS
IS NOT IDEAL BUT I HAD TO DIAL
THAT BACK AND SAY THOSE ARE
BULLETS AND NOT RANKED.
THAT WAS OUR ASK.
THAT'S IT, I WILL SAY THAT JUST
TALKING ABOUT THE BEHAVIORAL
SOCIAL SCIENCE TASK FORCE, THAT
YOU KNOW, THE KEY HERE, AND I
THINK I'M SPEAKING ON BEHALF OF
THE WHOLE TASK FORCE
PERHAPS, YOU KNOW, THE FIELD
THAT WE REALLY NEED TO LISTEN
TO TH CLOSEST TO THE
PAIN.
AND GIVEN A SEAT AT THE TABLE
AND I THINK IT'S JUST THAT
IDEA, AND AGAIN, IT'S THE FOR
IMPLEMENTATION SCIENCE POINT OF
YOU, IT'S THE SO WHAT WE KNOW A
LOT OF THESE DISPARITIES, IT'S
BEEN 40 YEARS AND NOW IT'S WHAT
DO WE DO ABOUT IT?
AND HOW DO WE REDUCE THESE
DISPARITIES AND WHAT ARE THE
AFFECTIVE INTERVENTIONS TO GET,
YOU KNOW, PEOPLE TO TAKE THEIR
PILLS OR TO TAKE A SHOT IN THE
ARM.
SO TO ME, IS THAT BEING
PRACTICAL ABOUT THOSE POINTS?
AND AGAIN, I MEAN, I, I AM VERY
HUMBLED TO HAVE BEEN CHAIRING
THIS BUT IT'S A LOT OF PEOPLE
THAT WERE THERE AND IT'S THE,
THE BRAINS OF A LOT OF PEOPLE
THAT PARTICIPATED, THE EX
EXECUTOR AND TASK FORCE MEMBERS
WERE REACTIVE AND THOUGHTFUL IN
THEIR CONTRIBUTIONS.
SO I'M VERY THOUGHTFUL FOR THAT.
>> THANK YOU.
>> THANK YOU I WANT TO THANK
THE TASK FORCE FOR CREATING
AEFR ARCHING STRUCTURE.
THIS IS A NOT, A SET OF
PRIORITY, PRIORITIES OCCUR AT
THE, WE'RE THE NUNS HAVE THE
FUNDINGS AND EXECUTION OF THE
RESEARCH THAT WE ARE ASSIGNED
BY STATUTE TO PERFORM.
SO I THINK THAT THERE IS ENOUGH
HERE THAT ALLOWS THE INSTITUTES
TO FIT THEIR PRIORITIES WITHIN
THE OVER ARCHING STRUCTURE.
AS I WAS WILL IS NOTING, THE
CLARITY CAME THROUGH, WHEN I
GET TO MY PRESENTATION WHICH IS
GOING TO TALK ABOUT THE NEXT
STEPS ONE OF MY SLIDES IS ABOUT
THE CENTRAL OF COMMUNITY.
SO THERECOITAREAS OF ALIGNMENT
AND ULTIMATELY THIS IS AT THE
INSTITUTE LEVEL.
WHERE FUNDING DECISIONS ARE
MADE.
>> THANK YOU,.
>> DR. NEILAN.
>> THANK YOU.
IT SHOULD BE INTERESTING TO
HAVE A LITTLE MORE INSIDE TO
PLANS EVIOUS STRATEGI
AND USED THAT AS A STARTING
PLACE.
>> DR. A.
>> THANKS SO MUCH, I WOULD LIKE
TO COMMEND THE TEAMS S WHAT
THEY'VE DONE.
TO CLUT MANUFACTURING FAACCESS
SO I JUST WANTED TO HIGHLIGHT
THIS VERY THOROUGH AND INCLUDED
SOME VERY CRITICAL COMPONENTS.
MY SECOND COMMENT WOULD BE IN
THE SECTION 3., 3 IN GENERAL
3.2 IN PARTICULAR.
I THINK DID A VERY GOOD JOB OF
POINTING OUT A LOT OF THE
IMPORTANCE OF LOOKING AT
RESOURCE LIMITED AND GLOBAL
SETTINGS, WHERE HIV HITS THE
HARDEST SO I THINK AT'S AN
IMPORTANT IT'S AN IMPORTANT
THEME THAT IS MENTIONED BUT
PARTICULARLY WELL IN THAT AND
IN THAT SESSION BECAUSE WE CAN
DO A LOT OF WORK HERE IN THE
STATES AND IT'S NOT JUST
IMPLEMENTATION SCIENCE BUT
ACROSS THE SPECTRUM UNTIL IT
REACHES THE COMMUNITIES WHERE
THE EPIDEMIC IMPACTS THE MOST,
WE WILL NOT HAVE THE RESULTS WE
WANT TO SEE.
SO THANK YOU FOR CAPTURING THAT.
>> THANK YOU.
I JUST WANT TO HIGHLIGHT ONE
THING, I WOULD AFTER THE FINAL
RECOMMEND AS ARE SHARED, IT
MIGHT BE USEFUL FOR THE
INSTITUTIONS TO LOOK AT THE
WERE DRAFTED BY
EACH OF THE TASK FORCE, WE HAVE
THEM TOGETHER BUT EACH ONE HAD
THEIR OWN VERSION OF THE
CAPACITY PRIORITIES THAT WERE
THEN KIND OF CONDENSED INTO
FOUR TO SIX.
BUT FOR EXAMPLE, THERE WERE
EXAMPLES THAT WERE PRIORITIZED
THAT WE'RE TALKING ABOUT HOW
PROFESSIONAL DEVELOPMENT
PROGRAMS COULD POTENTIALLY BE
MORE INTENTIONAL ABOUT A TYPE
AWARD WITH A SUPPORT
INTERNATIONAL INVESTIGATOR TO
GO BACK TO THE HOME COUNTRY
WITH REMAINDER OF OUR OLE FACE
FOR EXAMPLE OR SOME OTHER
PROGRAMS THAT WERE HIGHLIGHTED
BY OTHER INSTITUTIONS THAT WERE
REALLY LOOKED AT MODELS.
AND SOME OF THESE WERE SORT OF
REMOVED BY TRYING TO HAVING A
STANDARD REDUCTIVE 4-6 THAT
INFORMATION IS AVAILABLE SO I
INVITE OTHER INSTITUTES TO LOOK
AT THAT IF THEY HAVE AN
INTEREST.
>> I GUESS, ONE OTHER THING TO
HIGHLIGHT THAT, EACH OF THREE
TASK FORCE CONSIDERED WAS WE
TRIED TO KEEP THINGS BROAD,
RATHER THAN GETTING TOO
SPECIFIC OR TOO SCRIPT IVE AND
CARL, I THINK THAT DUCK TAILS
GOOD ON HOW EACH INSTITUTES
LOOK AT THIS.
WE TRIED NOT TO MAKE LISTTHAT
ALLOWED FLEXIBLE OR ALLOW
FUTURE INNOVATION FOR WHATEVER
COMES NEXT.
>> THANK YOU, ANY OTHER
COMMENTS, QUESTIONS?
BEFORE WE MOVE ON TO OUR NEXT
SESSION?
IT ULD BE IMPORTANT FOR THE
OARAC TO UNDERSTAND THAT A BIT
MORE ABOUT THE NEXT STEPS AFTER
THIS MOMENT.
I KNOW DR. DONENBERG ELUDED IN
THEY ARE TALK.
WHAT THE CHAIRS WILL BE DOING,
THE CHAIRS OF THE TASK FORCES
WILL BE COMPILING A WRITTEN
REPORT FROM THE MATERIAL YOU
SAW TODAY WITH DR. TURNBUAND
WE WILL SHARE IT WITH OARAC FOR
FINAL COMMENT BEFORE IT'S
SUBMITTED AS RECOMMENDATION
FROM THE OARAC.
SO WE'RE VERY CLOSE TO THAT,
BUT IT, BUT IT'S SORT OF PUBLIC
DELIBERATION OF THAT MATERIAL.
SO WE'RE ASKING FOR ANY
ADDITIONAL COMMENTS ORCO
QUESTIOROR CLARIFICATION TO IC
SEE COME IN IN ABOUT THE NEXT
TWO WEEKS OR SO SO THAT REPORT
CAN HAPPEN WELL BEFORE THE END
OF THE CALENDAR YEAR.
WE WILL NOW HEAR FROM UPDATE
FROM NIH ADVISORY COUNCIL
REPRESENTATIVE WE'LL HAVE
MARGARITA AND MELONY OTT AND
I'M NOT SURE IF CO RETTE BYRD.
>> THE NIH INVESTMENT IN THE
CLINICAL TRIALS NETWORK.
THE STATUS REPORT OF WHERE WE
ARE.
NEXT SLIDE PLEASE.
SO EVER 7 YEARS WE
COMPETITIVELY RENEW OUR
NETWORKS.
THE COMPETITIVE IS THE AWARDS
WILL BE IN 2027.
SO STARTING NOW HALFWAY THROUGH
THE CYCLE, WE ARE GOING THROUGH
A PLANNING PROCESS WITH
COMMUNITY, WITH RESEARCHERS,
AND OTHER ACADEMICS TO DEFINE
THE FORWARD LOOKING RESEARCH
AGENDA WHICH WILL DETERMINE THE
FOCUS STRUCTURE OR THE NETWORKS
PRIME AURLY RESEARCH AGENDA
THROUGH 2024, WE'RE TRYING TO
MAKE THIS A TEN-YEAR VISION.
NEXT SLIDE, PLEASE.
SO WE HAVE ESTABLISHED AN OUT
REACH SYSTEM TO STAKEHOLDERS.
THIS IS OUR WEBSITE WHERE
PEOPLE CAN GO IN AND READ WHAT
HAS BEEN POSTED.
THERE IS BEEN A SERIES OF
ENGAGEMENTS WHERE THERE WERE
EXTENSIVE QUESTIONS ASKED AND
THEN ANSWERED AND THE ANSWERS
ARE POSTED ON THIS SITE.
ADDITIONALLY, THERE IS A
HISTORY LESSON ON THE LEFT HAND
SIDE OF THE SCREEN IS A BOX
THAT INCLUDES ALL THE
INFORMATION FROM THE PREVIOUS
RECOMPETITION.
SO YOU CAN SEE HOW THESE
CONTINUE TO BE EVOLVED.
NEXT SLIDE, PLEASE.
SO AS EXAMPLE OF OUT REACH
ACTIVITIES, WE'VE HELD, THROUGH
OUR HIV NETWORK COMMUNITY
ACTIVITIES, WE'VE HAD TWO OF
THESE WEBINARS WHERE IN EACH
CASE WE HAD OVER 500 PEOPLE
REGISTERED FOR THESE AND THEY
CAME ON, AND HEARD PRESENTATION
SXZ FOR ABOUT 90 MINUTES TO 2
HOURS, THEY ASKED QUESTIONS, WE
CAPTURED THE QUESTIONS THAT
COULDN'T BE ANSWERED AT THE
TIME AND POSTED THOSE QUESTIONS.
WE INTEND TO HAVE ONE MORE OF
THESE HIGH-LEVEL VERY LARGE NAR.
IN THE MEANTIME, NEXT SLIDE,
WE'VE HAD THE ABILITY TO TALK
TO COMMUNITY AT NETWORK
MEETINGS AND RESENT AND I HAD
TWO SESSION WZ COMMUNITY.
BUT I WANT TO START FROM THE
PERSPECTIVE JUST LIKE WE JUST
HEARD FROM THE STRATEGIC PLAN
THAT OAR IS PUTTING TOGETHER,
IT'S CENTERED ON COMMUNITY.
SO WHAT WE WOULD LIKE TO DO IS
JUST CENTER OUR NETWORK
ACTIVITIES AS THEY'VE HAVE BEEN
ON COMMUNITY.
COMMUNITY PLAYS ESSENTIAL ROLES
WITH ENGAGEMENT, AND INPUT.
THEY HELP INFORM NETWORK
RESEARCH PRIORITIES, THEY
PARTICIPATE IN OUR SCIENTIFIC
COMMUNITIES IN OUR SCIENTIFIC
COMMITTEES, THEY PARTICIPATE ON
PROTOCOL TEAMS, THEY ARE THERE
TO VOICE CONCERNS ABOUT TRIALS,
THE WAY THEY'RE IT BEING
DEVELOPED, ABOUT HOW THEY'RE
BEING IMPLEMENTED IN OUTCOMES
AND REALLY HELPS ENSURE
ININFORMED CON SENSE.
AND ADVOCATE ON TRIAL
PARTICIPANTS AND THEY ALSO
SERVE A ROLE IN THE COMMUNITY
TO SELF EDUCATION AND INCREASE
THE KNOWLEDGE AROUND HIV AND
INCREASE AWARENESS OF WHAT IS
GOING ON IN EACH OF THESE
IMPORTANT AREAS.
THEY'RE ALSO ESSENTIAL FOR
HELPING US INTERPRET AND
DISSEMINATE RESULTS AND ALSO
HELP US PROMOTE ETHICAL
RESEARCH PRACTICES.
THOSE ARE THE FOUR NETWORKS
THAT RECURRENTLY HAVE LISTED AT
THE BOTTOM OF THE SCREEN.
NEXT SLIDE, PLEASE.
SO HERE'S WHERE OUR CURRENT
THINKING LIES.
WE ARE PROPOSING AT THIS POINT
TO MAINTAIN THE FOUR EXISTING
LEADERSHIP GROUPS.
WE HAVE OVER ARCHING THEME THAT
WE ARE MOVING, THAT WE HAVE
THAT WE'RE MOVING FORWARD WITH
THIS RENEWAL.
AND THOSE ARE INNOVATION AND
COLLABORATION.
AS WE LOOK AT JUST THE
PROGRESS, THE GROUND BREAKING
STUDIES THAT HAVE SPROUTED FROM
THESE COLLABORATIONS MANY OF
THEM WITHIN THE NETWORK, WITH
INSTITUTES WITHIN THE NIH.
LISTED THERE ARE THE, NIH
NETWORKS THAT ARE CURRENTLY
ENGAGED WITHIN THE CLINICAL
TRIALS INFRASTRUCTURE AND ALL
OF THEM HAVE SIGNIFICANT AREAS
OF EMPHASIS THAT THEY BRING TO
THE TABLE TO HELP US MAKE THE
RESEARCH THAT WE'RE SUPPORTING
THROUGH THE NETWORKS MORE
COMPLETE.
MOVING FORWARD WE WOULD LIKE TO
EXPAND OUT THIS LEVEL OF
COLLABORATION PARTICULARLY WHEN
WE GET TO THE NEED OF RESURGE
INTO OUR PLANS.
IF WE THINK ABOUT THE
IMPLEMENTING PARTNERS THAT ARE
PART OF THE SYSTEM, CDC, AND
OTHERS WHAT ARE THEIR STRATEGIC
NEEDS AS IMPLEMENTER THAT WE AS
RESEARCHERS CAN HELP WITH.
BUILT WITH THAT IS ARE THE
IDEAS THAT WERE ADDRESSED THE
NEEDS OF THE PARTNERS WILL BE
ESSENTIALLY CRITICALLY
IMPORTANT.
ADDITIONALLY, SINCE 20 19,
2020, THE CLINICAL TRIALS
ENTERPRISE THAT NIH SUPPORT
REALLY PROVED ITS MEDAL, TO
OPEN UP AND ADDRESS THE
PANDEMIC RESPONSE IN TERMS OF
PERFORMING THE THERAPEUTIC
STUDIES THROUGH ACTIVE AND
THROUGH COV.P. N THE STUDIES OF
ANTIBODIES AND VACCINES.
IT'S ESSENTIAL THAT THEY
MAINTAIN THIS THAT IS ABLE TO
TURN ON A DIME AND BE READY IF
AND WHEN THE NEXT PANDEMIC
ARISES.
NEXT SLIDE, PLEASE.
SO ONE OF THE AREAS THAT CAN
BE, WHAT ARE THE AREAS THAT WE
CAN PILE IT BETWEEN NOW AND THE
END OF THE CURRENT CYCLE?
AND THE FUNCTION FOR SCIENTIFIC
DISCOVERY THAT CAN BE MADE NOW
THAT WILL HELP US ACCELERATE
THE PACE OF DISCOVERY.
NEXT SLIDE, PLEASE.
SO JUST TO REMIND EVERYBODY
THIS IS OUR BASIC STRUCTURE,
EACH STRUCTURE CONSIST OF
LABORATORY, AND A LABORATORY, A
DATA MANAGEMENT SYSTEM CENTER,
A LEADERSHIP AND OPERATIONS
CENTER AND THEN AROUND THE
SIDES ARE THE TYPES OF NETWORK
OVERSIGHT AND COORDINATION THAT
WE SEEK TO USE TO OVERSEE THESE
NETWORK ACTIVITIES, AT THE
BOTTOM, THE LITTLE VIRUS LIKE
PARTICLES WITH THE CLINICAL
TRIALS UNITS AT THE CENTER AND
THE CLINICAL RESEARCH SITES
WHICH ARE THE KNOBS ON THE END
OF THIS FOLKS.
HERE'S A LITTLE BIT OF DETAILS
ABOUT HOW THOSE STRUCTURES
EXIST, AT LEAST THREE MODELS
FOR HOW CLINICAL RESEARCH UNITS
ARE CAN BE BROUGHT IN.
AND IT'S IMPORTANT THAT WE
MAINTAIN THIS FLEXIBILITY AS WE
MOVE FORWARD CAUSE NOT ALL
RESEARCH IS DONE IN AN ACADEMIC
SETTING.
FOR EXAMPLE, RIGHT NOW WE HAVE
A STUDY IN BARBER SHOPS AND
WE'RE USING, NON TRADITIONAL
SITES TO PERFORM THESE TYPES OF
STUDIES.
BY HAVING PROTOCOL SPECIFIC
SITES, WE CAN UTILIZE THAT KIND
OF IMPORTANT ACTIVITY AND
COMMUNITY TO HELP US REACH THE
POPULATIONS WE ARE SEEKING TO
REACH.
NEXT SLIDE, PLEASE.
SO, I HAVE A LITTLE BIT ABOUT
EACH OF THE AREAS BUT A LOT OF
THIS, IS VERY WELL KNOWN TO
THIS GROUP ABOUT WHAT EACH OF
THESE NETWORK ACTIVITIES COVER.
SO I WILL GO THROUGH THIS
RELATIVELY QUICKLY IN THE
INTEREST OF TIME.
CLEARLY FOR HIV PREVENTION, IT
IS ABOUT SUPPORTING BIO MEDICAL
PREVENTION INTERVENTIONS THAT
CAN CHANGE CLINICAL PRACTICE
AND REDUCE INCIDENTS.
THE OVER ARCHING GOAL THAT WE
SEE FOR OUR PREVENTION RESEARCH
FOR HIV VACCINES AND PREVENTION
IS DEVELOP THE TOOLS AND
TECHNOLOGY THAT WILL REDUCE HIV
INCIDENTS BOTH DOMESTICALLY AND
GLOBALLY.
WE'VE SEEN THAT THROUGH THE
MALE CIRCUMCISION, WE'VE SEEN U
WEEKALS U BECOME A MAJOR TOOL
AND RECENTLY WE HAVE SEEN
VAGTIER FOR MEN AND WOMEN.
LENACAPAVIR IS IN THE PROCESS
OF FILING FOR APPROVAL SO AS OF
RIGHT NOW, LENACAPAVIR, REMAINS
THE INJECT AB THAT HAS BEEN
AVAILABLE FOR USE AND SAFE TO
BE PREGNANCY SO IT CAN BE USED
ACROSS THE LIFE SPAN.
NEXT SLIDE, PLEASE.
FOR EACH OF THESE AREAS, I
LISTED THE PARTNERSHIP, WE WORK
CLOSE WITH THE INSTITUTIONS,
COLLABORATION WITH CDV,
INTERNATIONAL GOVERNMENTS, AND
INDUSTRY.
THIS IS NOT JUST ABOUT ADULTS
BUT ALSO ABOUT PEDIATRICS, THIS
IS AN OPPORTUNITY FOR US TO
REALLY TAKE NEW STRATEGIES TO
HELP US REDUCE VERTICAL
TRANSMISSION BY COORDINATING
WHAT WE'RE DOING IN THE AREAS
OF PREVENTION AS WELL AS
THERAPEUTICS AND CURE RESEARCH
IN THOSE INCREDIBLY POPULAR
POPULATIONS.
AN ESSENTIAL PARTNER FOR ALL OF
OUR PREVENTION WORK AND FRANKLY
OUR WORK ACROSS THE BOARD IS A
PART OF NIH, ANOTHER INSTITUTE
NATIONAL INSTITUTE FOR MENTAL
HEALTH, THAT IS COLOCATED WITH
THE DIVISION OF AIDS HERE AT
FISHERS LANE AND BECAUSE OF
THEIR STRENGTH AS BEING
BEHAVIORAL SCIENTISTS, WE
REALLY HAVE THE BEST OF BOTH
WORLD'S WITH THE STRONG
BIOMEDICAL PROGRAMS THAT NI A
ID CAN DEVELOP BUT THEN PARTNER
WITH NIH AND BRING THE BEST
BEHAVIORAL AND SOCIAL SCIENCE
ALL BETTER.
AS EVERYBODY KNOWS, PILLS AND
SHOTS AND MEDICINES, DO NOT
TAKE THEMSELVES.
THIS IS ONE OF THE STATEMENTS
THAT WE MAKE TO EACH OTHER ALL
THE TIME.
BUT BEHAVIORAL COME POENTS ARE
CRITICAL ACROSS THE ENTIRE
SPECTRUM.
NEXT SLIDE, VACCINE ALTHOUGH AN
AREA THAT REMAIN IMPORTANT.
ONE OF THE QUESTION THAT IS
CONSTANTLY BEING ASKED IS WHY
DON'T WE JUST STOP AND THE
ANSWER, I THOUGHT THAT WAS VERY
CLEAR TODAY FROM THE DISCUSSION
ON LENACAPAVIR, YOU CANNOT
ACHIEVE CONTROL OF THE GLOBAL
PANDEMIC THROUGH THE USE OF
LENACAPAVIR OR INJECTABLES,
IT'S NOT COST AFFECTIVE EVER,
WE ARE GOING TO NEED, FIRST OF
ALL GOVERNMENTS ARE ONLY GOING
TO BUY ENOUGH MATERIAL TO
PROVIDE SERVICES TO THE MOST
VULNERABLE AND MORE AT-RISK
POPULATIONS.
THE GOAL OF WHICH IS SAFE
AFFECTIVE AND DURABLE AND DOES
NOT NEED TO BE REGIVEN EVERY
SIX MONTHS REMAINS OUR GOAL.
SO THAT'S ALL I'LL SAY ABOUT
VACCINES.
NEXT SLIDE, PLEASE.
PARTNERS, ARE LISTED THERE.
WITHIN THIS IS ALSO NOT JUST
PREVENTION OF HIV BUT ALSO
PREVENTION OF COMORBIDITY,
INCLUDING WORK ON TB VACCINES,
TB RETAINS THE SINGLE BIGGEST
COST OF MORBIDITY WITH PEOPLE
LIVING WITH HIV SO TREATING TB
IS ESSENTIAL GOING FORWARD.
NEXT SLIDE PLEASE.
FOR HIV THERAPEUTICS, THIS IS
AN IMPORTANT ONE.
ONE OF THE AREAS THAT WE FEEL
VERY STRONGLY ABOUT, IS IN
TERMS OF DEVELOPMENT OF
MEDICINES FOR TREATING AND
CURING HIV, WE IN MANY WAYS ARE
ESSENTIAL TO THE PIPELINE.
BUT WHEN IT COMES TO THE NON
INFECTIOUS COMORBIDITY, WE'RE
NOT THE INSTITUTE FOR HEART
DISEASE OR LUNG BE SEAS OR
KIDNEY DISEASE OR BONE
DISEASE, THE DISCOVERY IN THOSE
DISEASES EXIST IN OTHER
INSTITUTES.
SO THE ABILITY TO FORM
PARTNERSHIPS ACROSS THE NIH TO
HELP BRING FORWARD NOVEL
STRATEGIES TO DEAL WITH
MORBIDITY, SO WE CAN CREATE AS
AS WE REFER TO AS THE 495 OR
THE LAST 95 WHERE THE PEOPLE
LIVING WITH HIV ARE LIVING
HEALTHY LIVES.
WITH SIGNIFICANTLY REDUCED
LEVELS OF COMORBIDITY AND THAT
HAS TO BE AN NIH ACTIVITY AND
THAT'S SOMETHING THAT WE WOULD
LIKE TO SEE AS PARTNERSHIP
MOVING FORWARD.
THERE WAS A FAIR AMOUNT OF
DISCUSSION THAT WE JUST HEARD
ABOUT THAT KIND OF ACTIVITY TO
ENGAGE THE RESEARCH COMMUNITY
AS WELL AS ENGAGE COMMUNITY AND
IDENTIFYING THOSE NEEDS AS WELL
AS INDUSTRY.
BUT, BRINGING THE INSTITUTES TO
THE TABLE, TO HAVE THOSE LINKS
IN THOSE INDUSTRIES WILL BE
ESSENTIAL FOR THE AIDS
COMMUNITY TO HELP TACKLE NON
INFECTIOUS COMORBIDITY.
SO IT'S ABOUT CREATING EQUITY
FOR ALL THROUGH THE DEVELOPMENT
OF NOVEL THERAPISTS, SO
OPTIMIZE BOTH PEDIATRIC DAILY,
THAT WILL BE IMPORTANT AS THESE
CHILDREN AGE UP INTO
ADOLESCENCE AND WE WANT TO BE
ABLE TO WORK WITH PARTNERS TO
IMENT --IMPLEMENT OUR
DISCOVERIES.
NEXT SLIDE, PLEASE.
HIV CURE REMAINS ABSOLUTELY
ESSENTIAL ON GOAL FOR OUR
RESEARCH WE WANT TO BE ABLE TO
CONTINUE TO DEVELOP STRATEGIES
THAT ERADICATE REPLICATION AND
CONFIDENT RESERVOIR OR DEVELOP
STRATEGIES TO CONTROL VIRAL
REBOUND WITHOUT IV ERADICATION
IN THE ABSENCE OR SUSTAIN VIRAL
REMISSION.
IT'S ALSO ESSENTIAL THAT WE
WORK ACROSS THE LIFE SPAN IN
THIS AREA.
THERE IS A UNIQUE OPLATION OF
BABIES THAT ARE BORN INFECTED.
AND THE NETWORK THAT'S JUST
COMPLETED A PROTOCOL TRYING TO
REPLICATE THE MISSISSIPPI CHILD
EXPERIENCE.
AND THAT REALLY PROVED TO BE
INCREDIBLY VALUABLE AS THAT HAS
BEEN COMPLETE ASKED NOW WE'RE
MOVING ON TO ADDITIONAL, A
SECOND VERSION OF THAT PROTOCOL
THAT WE CAN EXPAND TO A POINT
WHERE THROUGH THE USE OF LONG
ACTING MEDICINES, PLUS EARLY
TREATMENT, WE CAN REDUCE
SIGNIFICANTLY THE LEVEL OF HIV
ACQUISITION THAT A OCCUR
VERTICAL OR THROUGH BREAST
FEEDING AND THE CHILD CAN GO
INTO A PROTOCOL AND BE TREATED
IN A WAY THAT WILL ALLOW THEM
TO, HAVE A CHANCE OF HAVING
THEIR HIV CURED.
SO IT'S, IT'S AN INTERESTING
MODEL, IT'S AN INTERESTING
APPROACH FOR TACKLING PEDIATRIC
HIV AND ONE THAT WE CAN START
WITH QUICKLY AND EXPAND THROUGH
THE RENEWAL.
ADDITIONALLY BEING ABLE TO MOVE
CURE ACTIVITIES FOR DISCOVERY
AS WELL AS TRANSLATION OUTSIDE
OF THE LOWER 48 STATES IS
EXTREMELY IMPORTANT AND WE ARE
BUSY DESIGNING PROGRAMS TO
IMPLEMENT CLINICAL ACTIVITIES
IN LOW AND MIDDLE INCOME
COUNTRIES AND WISH TO CONTINUE
TO EXPAND THAT AS THE
OPPORTUNITIES CONTINUE TO
PRESENT THEMSELVES.
NEXT SLIDE, PLEASE.
THESE ARE THE CHALLENGES,
THEY'RE NOT, THEY REMAIN
SIGNIFICANT CHALLENGES AND WE
WILL CONTINUE TO DEVELOP THE
TOOLS AND TECHNOLOGIES TO
ADDRESS THESE.
NEXT SLIDE, PLEASE.
AND THAT'S IT FOR ME.
AGAIN, I THOUGHT I WAS REALLY
IMPORTANT TO GIVE THE OARAC AN
OVERVIEW OF WHAT WE ARE
CONSIDERING AND WHERE WE ARE.
OUR TIMELINE ALLOWS US NOW TO
TAKE FEEDBACK FROM PEOPLE WHO
WISH TO TO CONTINUE
CONVERSATIONS ABOUT THIS.
WITH A GOAL TOWARD HELPING TO
SHAPE THE NETWORK STRUCTURES
INTO SOMETHING THAT IS
OPTIMIZED FOR COLLABORATION AND
INNOVATION BETWEEN NOW AND 2034.
THANK YOU.
>> THANK YOU, WE'LL WAIT UNTIL
ALL THE PRESENTATION RIGHT SIDE
MADE AND IF ANY MEMBERS HAVE
QUESTIONS, WE'LL GET TO THAT
THEN.
CAN, DR. LIGHTFOOT, YOU MAY
BEGIN.
>> THANK YOU, DR. TURNBULL.
IT'S MY PLEASURE TO PROVIDE AN
UPDATE ON ACTIVITY OF NIMH.
ONE OF THE BIGGEST PIECES THAT
THEY HAVE A NEW INTERIM
DIRECTOR AND THIS IS A NICE
WORK OF WHAT SHELLEY PUT
TOGETHER ABOUT WHAT HER WORK
HAS PUT TOGETHER.
SHE CAME TO NIH IN 2001 AND
JOINED THE NIMH AS A SCIENTIST
AND MOVED IN 2005.
ULTIMATELY VERY BECAME THE
CHIEF OF THE DEVELOPMENTAL
TRAJECTORY MENTAL HEALTH
DISORDER BRANCH.
WHILE THERE, SHE LEAD THE PAOED
ATTRITION TRANSFORM PORTFOLIO
AND THAT REORIENTING EMPHASIS
ON BEHAVIORAL DEVELOPMENT TRO
JEKT REESE OF ILLNESS AND
IDENTIFICATION OF EARLY
BIOLOGICAL BEHAVIORAL.
SHE IS ALSO DEVELOPED SEVERAL
RESEARCH PROGRAMS FOCUSED ON
DEPRESSION AND BIPOLAR AND
CHRONIC IRITIABLEITY IN
CHILDREN.
AND A COUPLE OF OTHER MAJOR
STAFF CHANGES WHERE NICOLE
MARTINO WAS APPOINT
APPROXIMATED NIMH EXECUTIVE
OFFICER DEPUTY DIRECTOR.
AND SHE WAS PREVIOUSLY ACTING
EXECUTIVE OFFICER FOR THE PAST
SIX MONTHS, SHE IS SUCCEED WHO
WAS EXECUTIVE OFFER BEFORE
RETIRING IN FEBRUARY OF 2024.
THE SECOND MAJOR STAFF CHANGE
IS SUSAN COESTER AS APPOINTED
ACTING NIMH DEPUTY DIRECTOR IN
NUERO SCIENCE AND GENO TYPE
EXPRESSION.
ONE OF THE LARGEST ACTIVITY
THAT NIMH HAS BEEN ENGAGED IN
IN THE LAST YEAR, IS 75th
CELEBRATIONS AND THAT CONCLUDE
THE CELEBRATION AND ANNIVERSARY
FINAL AND FINAL SYMPOSIUM WHICH
OCCURED ON SEPTEMBER 20, 2024
AND THAT SYMPOSIUM FOCUSED ON
THE INSPIRATION DRIVING NIMH
RESEARCH.
THE FIRST WAS SHARYL BELLMY WHO
COWROTE A BOOK AND PLAYS IN
MONOLOGUES THAT WAS CALLED
POSITIVE NEGATIVE, WOMEN OF
COLOR AND WOMEN OF AGE AND TOLD
HER STORY HER PROJECTORY IN
JOURNEY BEGAN WITH THE
ATTENDING UNIVERSITY OF
MICHIGAN TO DO RESEARCH.
THE SECOND PERSON SPOTLIGHTED
IN NIMH SIM POSIAL WAS A
DOCTORAL STUDENTS NAMED JOHN
JERAMILIO AT THE HEALTH
UNIVERSITY OF MIAMI.
RESEARCH IS CENTERED ON HEALTH
OF MINORITY WITH INTEGRATING
IDENTITY AND CULTURE
CONSIDERATION IN THE HEALTH
PROMOTION FOR THAT POPULATION.
THEY HAVE ALSO WORKED WITH
DEVELOPING AND TESTING
INTERVENTION AND CULTURAL
CONFIDENT CARE FOR COMMUNITIES
IN SOUTH FLORIDA.
SO I THOUGHT IT WAS WONDERFUL
THAT NIMH WAS INCLUDED.
AND SPOT LINE ON MATERNAL
HEALTH AND THAT OCCURED ON
SEPTEMBER 16th WHERE THE OFFICE
OF DISPARITY RESEARCH WORKFORCE
DIVERSITY ALONG WITH THE NIH
OFFICE OF RESEARCH OF WOMEN'S
HEALTH CO-HOSTED A ROUNDTABLE
AS PART OF THE NIH EVALUATING
WOMEN'S VOICE TO SEE IMPROVE
MATERNAL HEALTH SERIES.
SO THIS IN PARTICULAR, I THINK
IS WHILE IT WAS NOT SPECIFIC TO
HIV, IT REPRESENTS AN
OPPORTUNITY TO REALLY HIGHLIGHT
HIV RESEARCH AND ITS IMPACT ON
THE HEALTH OF WOMEN OF COLOR.
SO DURING THIS ROUNDTABLE,
SPEAKERS HIGHLIGHTED HIGH
PRIORITY RELATED TO WOMEN'S
HEALTH DURING PREGNANCY AND
POST PARTUM PERIOD AND EXPLORED
HOW RESEARCH CAN REDUCE THE
BURDEN OF MENTAL ILLNESS THAT
CONTRIBUTE TO IMMORTALITY.
AND THEN THE LAST THING WAS
THAT THERE WAS A THAT MAY BE OF
INTEREST OF THIS GROUP IS
RESPONSIBLE USE OF ARTIFICIAL
INTELLIGENCE AND RESEARCH IN
THERE IF ANYONE IS INTERESTED
IN THAT.
NEXT SLIDE, PLEASE.
SO YOU'VE HEARD A LOT ABOUT THE
BUDGETS SO JUST IN TERMS OF
THOSE IMPACTS ON AND I MENTION
SPECIFICALLY, SO AS YOU ALL
KNOW, PRESIDENT BIDEN SIGNED
THAT APPROPRIATIONS ACT IN
2024, THAT PROVIDED FUNDS
THROUGH SEPTEMBER 30th.
SO THAT LAW PROVIDE ABOUT 2.3
MILLION DOLLARS TO NIMH AND
THAT APPROPRIATION REFLECTED
THAT INCLUDED FUND TO GO NIMH
THAT INCLUDED AN INCREASE OF
ABOUT 75 MILLION TO SUPPORT
RESEARCH FOCUSED ON DEVELOPING
TARGETS PREVENTIVE INTER
INTENTIONS AND TREATMENT FOR
MENTAL ILLNESS AND ALSO,
APPROPRIATION INCLUDE INCLUDES
130 MILLION REDUCTION IN THE
21st CENTURY FOR THE BRAIN
RESEARCH THROUGH ADVANCING
NUERO TECHNOLOGY SO THAT BRAIN
INITIATIVE.
IN TERMS OF NEW GRANTS AWARDED,
WHAT YOU SEE HERE ON THIS
SLIDE, NIMH INTENDS TO AWARD
ABOUT 600 NEW COMPETING
PROJECTS IN 2024, GIVEN THAT
FUND THATING WAS AVAILABLE AND
WITH ESTIMATED SUCCESS ABOUT 22
PERCENT WE IS REFLECTIVE OF
ABOUT WHAT IT'S BEEN IN THE
LAST COUPLE OF YEARS.
NEXT SLIDE, PLEASE.
OKAY.
SO IN TERMS OF AN UPDATED ABOUT
THE APPROPRIATIONS, AND HOW
IT'S IMPACTING NIMH ON THE
REQUEST FOR NIMH WAS ABOUT 2.5
MILLION THAT REQUESTED INCLUDED
10 MILLION FOR IMPLEMENTATION
INITIATIVE AND 190 MILLION FOR
OTHER MENTAL HEALTH RESEARCH
SUPPORTING BETTER DIAGNOSTICS
AND ENHANCE PREVISION.
: THE HEALTH INCLUDED ABOUT 3.2
MILLION COMBINING AN INCREASE
OF 23 MILLION OF GENERAL
APPROPRIATION WITH A 3.1
MILLION AND THEN THE SENATE
APPROPRIATIONS BILL WOULD
APPROPRIATE 2.7 MILLION TO NIMH
RESTORING FUNDING FOR THE BRAIN
INITIATIVE AND PROVIDING 275
MILLION TO SUPPORT RESEARCH
FOCUSED ON TARGETED PREVENTION
OF AND FOR MENTAL ILLNESS.
THAT GIVES YOU THE SENSE OF
WHAT THE BUDGET FOR NIMH IS
LOOKING LIKE.
NEXT SLIGHTED, PLAS ALSO THE
LAST NIMH MEETING FEW
SPOTLIGHTS ON RESEARCH.
TWO OF WHICH WERE HIV-RELATED.
THE FIRST, IT'S ANOTHER INFECTS
THE NERVOUS SYSTEM AND
ESTABLISHES PERSISTENT VIRAL
INFECTION THAT MAKES IT
DIFFICULT TO ERADICATE THE
VIRUS.
SO HIV IS BELIEVED AS YOU ALL
KNOW, BELIEVED TO PREDOMINANT
PERSIST IN A DOR MENT STATE IN
BRAIN CELLS, BMCs AND PLAY
CRITICAL ROLE IN RESPONDING TO
THE INFECTION.
SO DR. YAWNING OVER THE
UNIVERSITY OF, A SINGLE CELL
TECHNOLOGY TO IDENTIFY FACTORS
SIGNALING PATHWAYS THAT CONTROL
DORMENT.
SO THIS RESEARCH DR. SEANING
AIMS TO BETTER UNDERSTAND
PERSISTENT WITHIN THE CENTRAL
SYSTEM AND DEVELOP NOVEL TERMS
IN THE BMCs SO HOPEFULLY MOVING
US ONE STEP CLOSER TO
ERADICATING HIV IN THE BRAIN.
THE SECOND SPOTLIGHT I THOUGHT
THIS WAS REALLY RELEVANT FOR A
POPULATION THAT IS HIGHLY
VULNERABLE TO HIV AND THE
FINDINGS WILL BE RELEVANT TO HIV
TRANSGENDER AND NON BINARY
THOSE WHO IS IDENTITY DOES NOT
RELATE TO SEX ASSIGNED TO THEM
AT BIRTH, THEY'RE TWICE LIKELY
TO EXPRESS DEPRESSION AND
SUICIDE BEHAVIORS.
HIGH QUAUNT HEALTHCARE DUE TO
THE STIGMA, DUE TO SHORTAGE IN
SPECIALIZED SERVICES.
SO WITH FUNDING AND SERVICES
AND INTERVENTION RESEARCH DR.
CHEN FROM CHILDREN HOSPITAL IN
CHICAGO AIMED TO PILOT TEST A
MOBILE PHONE APPLICATION, A
PHONE APP THAT IS BASED ON
BEHAVIORAL THERAPY.
INTERNIZE TRANS PHOBIA NEGATIVE
FUTURE EXPECTATIONS, IDENTITY,
NON DISCLOSURE AND NON GENDER
IDENTITY PRIDE, SO COACHING SO
EITHER BY PHONER OWE I WILL CAN
IMPROVE.
SO THE RESULTS CAN YIELD
CRITICAL DATA TO INFORM LARGE I
IMPLEMENTATION.
FOR ALL OF THESE YOUNG PEOPLE.
NEXT SLIDE, PLEASE.
THERE WAS ALSO ONE HIV-RELATED
CONCEPT CLEARANCE PRESENTED, SO
THE PURPOSE OF THIS CONCEPT WAS
TO IDENTIFY MODIFIABLE TARGETS
AND MECHANISM TO SEE ALLEVIATE
CLINICALLY CENTRAL SERVICE
COMPLICATION SXZ DEVELOP
COMPREHENSIVE VALIDATED
TREATMENT STRATEGIES TO IMPROVE
OUTCOMES PEOPLE LIVING WITH HIV
BUT IMPROVE QUALITY OF LIFE AND
REDUCE SYSTEM SEVERITY AND
EXPERIENCING ADVERSITY.
FURTHERMORE, THE CONCEPT TO
REALLY ENCOURAGE ADOPTING MILD
BASE, GO NO GO IN TREATMENT
STRATEGIES DESIGN COUPLED WITH
TESTING TO VALIDATE TARGET EN
GIJMENT AND CHANGES OUTCOMES
AND ENSURING THAT ONLY
PROMISING ARE INVOLVED.
IN TRAIL PHASES.
SO THIS CONCEPT EXTENDS AND
IT'S EXPERIMENTAL PARADIGM TO
TREATMENT STRATEGIES.
SO THE MOST TREATABLE TRADES
CONTRIBUTE TO GO PATH O
GENESIS AND PEOPLE LIVING WITH
HIV AND THIS CONCEPT OF LISTED
APPROVED BY COUNCIL.
NEXT SLIDE PLEASE.
AND THEN, THERE ARE TWO FEATURE
FUNDING MECHANISMS.
THE FIRST IS NIMH RESEARCH
MENTORING FOR HIV RESEARCHERS.
THIS MECHANISM HAS FUNDED HIV
PROGRAMS FOR A WHILE AND IT'S
INTENDED TO SUPPORT AND
CONTINUED TO SUPPORT RESEARCH
ACTIVITIES.
THE OVER ARCHING GOAL OF THE
R25 PROGRAM IS TO SUPPORT
ACTIVITIES AND ENHANCE THE
WORKFORCE TO MEET THE NATION'S
BIO MEDICAL BEHAVIOR.
THE SECOND, THE SECOND IS FOR
MECHANISM BETWEEN HIV NUERO
INFLAMMATION AND SEEING
PERSISTENT HOW THE IMPLICATIONS
ARE IN HIV NUERO PATHOGENSIS.
NUERO INFLAMMATION AND HIV
PERSISTENCE AND TO RESEARCH
DEFINING THE ROLE AND
MECHANISMS OF DEFECTIVE PRO
VIRUSES HIV PROTEINS AND
REDUCING INFLAMMATION.
I THINK THAT'S IT, THANK YOU
VERY MUCH.
>> THANK YOU SO MUCH, DR.
LIGHTFOOT FOR THAT UPDATE.
DR. OTT, PLEASE PROCEED.
>> YEP.
HELLO EVERYBODY, I'M SLIGHTED
TO PROVIDE SOME HIGHLIGHTS FROM
THE NATIONAL INSTITUTE OF DRUG
ABUSE, NAIDA.
WOULD LIKE TO HIGHLIGHT ONE OF
THE PAPERS, ONE OF THEIR PAPERS
IN THEIR PORTFOLIO THAT WAS
GENERATED BY ONE OF THEIR A
VANGUARD AWARD RECIPIENTS, LEO
WINEBERGER HE HAS USED TIPS
THERAPEUTIC INTERFERING
PARTICLES WHICH ARE DERIVED
FROM DEFECTIVE INTERFERING
PARTICLES TO INTERFERE WITH HIV
AND IT'S ACTUALLY BEAUTIFULLY
FITTING INTO WHAT WES HAS TOLD
US EARLIER ABOUT CAPSID AND HIV
ASSEMBLY.
NEXT SLIDE.
BECAUSE THESE TIPS ARE
BASICALLY MINI HIV VIRUSES OR G
NODES THAT RELY ON
COMPLIMENTATION OF CRITICAL
VIRAL PROTEINS EN VIERRAL SO
THE TIP STEALS PROTEINS FROM
THE VIRUS AND TO PROPAGATE ITS
OWN REPLICATION AND A MAJOR
POINT OF, OF INTERACTION IS THE
CAPSID THAT THAT IS BEING
EXCHANGED.
AND SO THE MODEL IS THAT THESE
ENGINEERED DEFECTIVE PARTICLES
ARE SHORTER, THEY REPLICATE
FASTER AND THAT'S WHY, THEY YOU
KNOW, DOMINATE OVER THE FULL
LENGTH VIRUS IN THE CELL AND
THIS HAS BEEN ZONE IN THIS
PAPER, ALSO IN MONKEYS WHERE A
SINGLE DOSE OF THE TIP
PREVENTED THE MAJORITY OF
ANIMALS THAT GOT INFECTED WITH
THE SHIFT VIRUS FROM DEVELOPING
PATHOGENSIS AND STAYED
RELATIVELY HIGH OVER A MULTIPLE
MONTHS.
TTSZ NOT AFFECTIVE AS
LENACAPAVIR, WHICH WE HEARD A
LOT ABOUT TODAY, A PROMISING
AND POTENT CAPSID INHIBITOR, WE
HEARD ABOUT PURPOSE ONE AND
PURPOSE 2 STUDIES.
I WANT TO DRAW YOUR ATTENTION
TO THE PURPOSE 4 STUDIES WHICH
IS DESIGNED FOR PEOPLE WHO
INJECT DRUGS AND IT'S CURRENTLY
NOT ROLLING AND WILL HOPEFULLY
ESTABLISH A SIMILAR HIGH
EFFECTIVENESS OF TWICE A YEAR
INJECTION IN PREVENTING
ACQUISITION ALONG PEOPLE WHO
INJECT.
NEXT SLIDE.
I WANT TO POINT OUT ANOTHER
VERY IMPORTANT ASPECT OF HIV
CARE, IS THAT CURRENTLY,
OVERDOSE IS AMONG THE GREATEST
THREATS TO PEOPLE WITH HIV
THIS WAS SHOWN IN A 2017
ANALYSIS IN NEW YORK WHERE,
WHERE HIV SURVEILLANCE FOUND
OUT THAT THE RATE OF OVERDOSE
DEATH OF PEOPLE LIVING WITH HIV
WAS MORE THAN DOUBLE WITH THE
OVERALL OVERDOSE DEATH RATES.
SO PEOPLE WITH HIV DIE ALMOST,
YOU KNOW, MORE THAN DOUBLE IN
RATES ON BY OVERDOSE.
AND THIS IS NOT BECAUSE THEY
ARE FALLING THROUGH THE CARE,
THE MOST OF THEM ARE 98 OF THEM
ARE IN CARE AND THEY ARE
ACTUALLY, LOOKED AFTER AND
RETAINED AND CARE AND MORE THAN
HALF OF THEM WERE VIRALLY
SUPPRESSED.
SO THIS IS NOT AN NEGLIGENCE
ISSUE BUT I THINK AS DR. NORA,
DIRECTOR OF NIDA AND DIRECTOR
OF NID POINTED OUT, IT'S A
SPECIFIC RESPONSIBILITY FOR
THESE HIV CARE CENTERS TO
INCLUDE EDUCATION AND
POTENTIALLY TRAINING
APPLICATION IN THESE, IN
INCORPORATE THAT INTO THE HIV
CARE.
AND I THINK HAVING THESE PEOPLE
IN HERE, IS REALLY UNIQUE
OPPORTUNITY HERE TO PREVENT
THIS LARGE OVERDOSE DEATH BY
OVERDOSE RATE IN ORDER TO MAKE
A DIFFERENCE IN THE FUTURE.
THE NEXT SLIDE.
ANOTHER IMPORTANT ASPECT THAT
WE WOULD LIKE TO HIGHLIGHT IS
THE HIV INFECTION IN PEOPLE WHO
ARE ASSOCIATED WITH THE
CRIMINAL LEGAL SYSTEM.
THERE IS A SPECIAL NIDA NETWORK
THAT HAS BEEN FORMED THE
COLLABORATIVE NETWORK TO END
THE HIV EPIDEMIC AND ADDRESS
ADDICTION IN THE CRIMINAL
JUSTICE SYSTEM.
AND THIS IS BASICALLY AN
INITIATIVE THAT CONSIST OF 8
GRANTS INCLUDING 7 ACADEMIC
RESEARCH HUBS AND A PATIENT
ENGAGEMENT RESOURCE CENTER WITH
THE GOAL OF, OF RESEARCH AND
CAPACITY BUILDING, BUILDING
RESEARCH AND CAPACITY BUILDING
PROJECT TO REALLY ADDRESS THE
UNIQUE NEEDS OF INDIVIDUALS
WITH HIV AND SUBSTANCE USE
DISORDER, AS THEY TRANSITION
BETWEEN THE CRIMINAL LEGAL
SYSTEM AND THE COMMUNITY.
SO THIS IS A NEW INITIATIVE
THAT REALLY ADDRESSES THIS
UNIQUE ASPECT OF HIV CARE THAT
IS ASSOCIATED WITH NIDA AND I
THINK THESE ARE ALL MY UPDATES
FOR TODAY.
>> THANK YOU SO MUCH, DR. OTT.
OUR FINAL UPDATE FOR TODAY WILL
COME FROM THE HIV CLINICAL
GUIDELINES WORKING GROUP OF
OARAC, JUST LET ME SAY BEFORE I
CONTINUE, WE HAD SCHEDULED MRS.
CORETTE BYRD BUT WE HAVE
RESCHEDULED SO SHE'LL BE
PRESENTING AT OUR FEBRUARY
MEETING.
OUR FINAL WILL BE FROM THE
GUIDELINE THESE INCLUDE BOTH
GUIDELINES AND PANEL UPDATE.
DR. DHANIREDDY WILL PROVIDE
UPDATES ON OPPORTUNISTIC
INFECTIONS.
DR. DHANIREDDY OVER TO YOU.
>> THANK YOU FOR INVITING ME.
THANK YOU FOR HAVING ME TODAY.
IF YOU CAN ADVANCE TO THE NEXT
SLIDE.
I THINK IT'S ON DR. BYRD.
>> WE'RE JUST PULLING UP YOUR
SLIDES, IT WILL TAKE A SECOND.
THANK YOU.
I'M ONE THE CO-CHAIR FOR THE
GUIDE LIESED OF OPPORTUNISTIC
INFECTION NEXT SLIDE.
WE HAVE PREPARATION FROM NIH,
TWO OF THEM INFECTIOUS AND HIV
MEDICAL ASSOCIATION.
THE CDC HAD ALSO HAD A
REPRESENTATIVE BUT AN UPDATE AS
OF THIS YEAR IS THAT CDC HAS
CHOSEN TO NOT APPOINT A
CO-CHAIR AND HAVE A FORMAL
RECOGNITION ON THIS GUIDELINE.
AT DR. BURKS HAD BEEN SERVING
AS IN THAT ROLE BUT HE RECENTLY
RETIRED WILL BE AN INDEPENDENT
CO-CHAIR WITH KNOWLEDGE IN THIS
AREA AND LONG TIME MEMBER OF
THE GUIDELINE.
THERE ARE 151 MEMBERS, 36 NEW
MEMBERS HAVE REPLACED RETIRING
MEMBERS OVER THE PAST YEAR.
AND WE HAVE 25 SUBJECT REPLETE,
SO THEY'RE EXPERTS IN THEIR
PARTICULAR AREAS THAT ARE
REPRESENTATIVES IN THE
GUIDELINES AND THEY LEAD A
GROUP OF OTHER MEMBERS IN THE
SUBCOMMITTEE THAT ALSO HAVE A
WIDE RANGE OF EXPERIENCE
RESEARCH AND CLINICAL, IN THAT
AREA.
AND WE'VE HAD 7 NEW SUBJECT
REPLETES THAT ARE REPLACED
RETIRING IN THE PAST YEAR.
WE HAVE 30 CHAPTERS AND THOSE
CHAPTERS ARE CONTINUOUSLY
REVIEWED.
WE HAVE REGULAR LITERARY
SEARCHES THAT ARE PUT THROUGH
AND ANY UPDATES THAT MAY IMPACT
THESE GUIDELINES ARE REVIEW AND
MATERIAL IS REVISED AS NEEDED.
NEXT SLIDE.
SO I KNOW DR. BULLIC IS ON HERE
AND ABLE TO TALK ABOUT THE
TREATMENT GUIDELINES AND YOU
CAN SEE WE'RE IN SECOND PLACE
IN THE TREATMENT GUIDELINES, WE
HAVE OVER HALF A MILLION VIEWS
THROUGH DECEMBER OF LAST YEAR
FOR THE YEAR AND WE ARE ON PAR
TO HAVE THAT OR MORE FOR THIS
YEAR.
NEXT SLIDE.
AND THIS IS AN INCREASE
COMPARED TO THE YEAR BEFORE,
AND WE KNOW THAT WE'RE SEEING
MORE LATE DIAGNOSES OF HIV THAT
CONTINUE SO THESE GUIDE LINES
ARE STILL RELEVANT FOR MANY,
EVEN THOUGH WE HAVE AREAS WITH
HIGHLIGHTS OF VIROLOGY, WE
CONTINUE TO SEE PEOPLE WITH
LATE STAGE DISEASE.
NEXT SLIDE.
THEN YOU CAN SEE A BREAK DOWN
OF ALL THE DIFFERENT SUBJECTS,
THAT BY PAGE VIEWS AND THE BLUE
OF BAR IS FROM THIS PAST YEAR
IN 2023.
PNEUMONIA IS THE MOST
FREQUENTED WEBSITE ON OUR IN
OUR GUIDELINES AS PEOPLE
REFERENCE TREATMENT AS WELL AS
PROFOLIX AND THEN WE HAD A
INCREASE USE FOR IMMUNIZATION
GUIDELINES THERE IS A NICE
TABLE REVIEWING ALL THE
RECOMMENDED VACCINES FOR PEOPLE
WITH HIV
NEXT SLIDE.
THIS SHOWS SORT OF BY COUNTY
EVEN THOUGH THESE ARE
GUIDELINES REALLY FOR THE
UNITED STATES, AND THAT'S WHERE
THE MAJORITY OF PEOPLE ARE THAT
ACCESS THE GUIDELINES.
YOU CAN SEE THAT THERE ARE A
NUMBER OF COUNTRIES THAT ALSO
USE THESE GUIDELINES FOR AND
INDIVIDUALS USE THESE
GUIDELINES IN THEIR PRACTICE
AND OTHER COUNTIES, INDIA BEING
THE BIG ONE HERE OUTSIDE OF U.S.
NEXT SLIDE.
SO WE HAVE A NUMBER OF RECENTLY
PUBLISHED UPDATES.
SO IN TERMS OF SECTIONS, WE
HAVE MTB VEX, WE WENT THROUGH A
HUGE OVERHAUL AND CONTINUES TO
HAVE AN UPDATE THAT IS
PUBLISHING, I'LL TALK MORE
ABOUT HPV.
AND LEASH MANSIS AND MYCO NN
BCTIUM.
SO NEXT SLIDE.
THE UPDATES THAT ARE GOING TO
BE PUBLISHED SOON, ARE THESE
AND I THINK THERE WAS A SLIDE
MISSING, BUT I'LL GET BACK TO
YOU IN A SECOND.
SO HISTO AND CRYPTO AND
SISCICCO ARE GOING TO HAVE
UPDATES.
SO FOR A SECOND, I WANT TODAY
TALK ABOUT THE HPV GUIDELINES.
SO THE HPV WENT A HUGE OVERALL
THIS YEAR AND REALLY IN
RESPONSE TO DATA FROM THE
ANCHOR STUDY WHICH CAME OUT A
COUPLE OF YEARS PRIOR, LOOKING
AT ANAL CANCER, THE TREATMENT
OF HIGH GRADE LESIONS AND THE
PRIMARY POINT WAS PROGRESSION
TO ANAL CANCER.
AND BASED ON THAT, THERE WERE
GUIDELINES THAT WERE PUBLISHED
BIT ANAL NEO PLACIA THAT
ADDRESSED ANAL CANCER SCREENING.
THESE WERE GENERAL GUIDELINES
AND OUR HPV GROUP MET AND
REVIEWED ALL OF THE GUIDANCE
AND THE DATA AND CAME OUT WITH
THE FIRST-EVER PUBLISHED
GUIDELINES FOR ANAL CANCER
SCREEN ANDING PEOPLE WITH HIV,
WHY THIS IS IMPORTANT ANAL HAS
A HIGHER INCIDENT WITH PEOPLE
ARE HIV AND WE KNOW THAT
IDENTIFYING HIGH GRADE LESIONS
AND TREATING THEM CAN PREVENT
THE DEVELOPMENT OF ANAL CANCER
WHICH IS A VERY HAS HIGH
MORBIDITY IN OUR PATIENTS AND
LEADS TO VERY DIMINISHED
QUALITY OF LIFE.
SO WE EXPECT TO SEE SOME
FURTHER ADJUSTMENTS AND
AMENDMENTS TO THESE GUIDELINES
AS WE GET MORE DATA AND AS
PEOPLE ARE STARTING TO
SCREENING MORE OVER THE NEXT
COUPLE OF YEARS.
THANK YOU.
>> THANK YOU.
THE NEXT UPDATE IS FROM DR.
TRIP GULICK.
DR. GULICK, YOU HAVE THE FLOOR.
>> THANKS VERY MUCH.
SO ANOTHER ROLE I SERVE IS
ACADEMIC CO-CHAIR OF THE ADULT
AND ADOLESCENT ANTI ANTI VIRAL
GUIDELINES, CLIFF IS THE NIH
CHAIR AND ALICE POWELL IS OUR
EXECUTIVE SECRETARY.
SO I'M PRESENTING ON BEHALF OF
THE PANEL.
SOL WHAT IS NEW WITH US, NEXT
SLIDE.
SHERISH JUST SHOWED YOU SOME
PAGES AND WE CONTINUE TO--PAGE
VIEWS CONTINUE ABOUT COUPLE
THOUSANDS AND THAT'S GONE UP
FROM ABOUT A HALF A MILLION.
SO IT CONTINUES TO BE A POPULAR
RESOURCE FOR PEOPLE TAKING CARE
OF PEOPLE CAN HIV
NEXT, COUPLE OF UPDATES FOR US,
SO IN FEBRUARY OF THIS YEAR, WE
CAME OUT WITH FORMAL
RECOMMENDATIONS FOR STATEN USE
WITH PEOPLE WITH HIV FOR CARD I
CAN'T VASCULAR--CARDIO VASCULAR
DISEASE, AND THIS SHOWING
DECREASE FOR CARD I CAN'T
VASCULAR BY A THIRD SO VERY
IMPRESSIVE RESULTS.
JUST LAST MONTH IN SEPTEMBER,
WE HAD A RELEASE OF NEW
GUIDELINES UPDATES, I'LL SHOW
YOU WHAT THOSE WERE.
A WEEK LATER, WE HAD OUR ANNUAL
PANEL RETREATS WHICH WAS HELD
IN WASHINGTON DC AND I'LL LET
YOU KNOW WHAT WE DISCUSSED.
AND IT SAYS SOON TO GO TO BE
RELEASED BUT IT HAS NOW BEEN
RELEASED WE HAVE UPDATED AND
RERELEASED CARING FOR PEOPLE
WITH HIV DISPLACEDS BY NATURAL
DISASTER AND THIS CAME OUT ON
OCTOBER 11, RIGHT BEFORE THE
RESENT TWO HURRICANES THAT HIT
THE SOUTHEASTERN UNITED STATES,
SO IT WAS A TIMELY UPDATE THERE.
NEXT, SO THE USE OF STATINS IN
HIV WAS AN IMPORTANT TOPIC.
IN REDUCING MIs AND STROKES AND
OTHER CARDIO VASCULAR
COMPLICATIONS TO CONTROL THEIR
LIPIDS.
AND WE ACTED VERY QUICKLY, WE
APPOINTED A LEADER JASON BAKER
FROM MINNESOTA, INCLUDED SOME
OF OUR MEMBERS AND THEN REACHED
OUT TO SEVERAL CARDIOVASCULAR
SOCIETIES, A.C. C AND A H A,
THE AMERICAN HEART ASSOCIATION
AS WELL AS ID S A ASKED PEOPLE
TO FORM A PANEL TO MAKE FORMAL
RECOMMENDATIONS FOR WITH HIV TO
TRY TO INCORPORATE THESE
RESULTS.
AND THESE DID COME OUT KIND OF
RECORD TIME, WE WERE VERY PROUD
OF THAT TO MAKE FORMAL
RECOMMENDATIONS TO
PRACTITIONERS AS TO WHAT TO DO
WITH STATINS AND AS YOU MAY
EXPECT, WE DID ENDORSE
STATINTHERAPY FOR PEOPLE WITH
HIV
WE ARE NOW GOING TO INCORPORATE
THIS INTO A MANUSCRIPT AND HOPE
TO SUBMIT THAT TO ANNUALS OF
MEDICINE.
AND THAT WAS ENDORSED BY ALL OF
THESE DIFFERENT GROUPS.
NEXT.
AS MENTIONED IN SEPTEMBER WE
CAME OUT WITH A MAJOR UPDATE TO
THE ANTI VIRAL GUIDELINES AND
GO THROUGH SOME UPDATES.
NEXT.
ONE BIG THING WAS TO ADD A BIG
SECTION.
WE HAD NEVER CONSIDERED ORGAN
TRANSPARENT IN HIV THAT IS
BECOMING INCREASINGLY COMMON
WEX LENT RESULTS.
WE COMMISSIONED ARTHUR KIM WHO
IS A PANEL MEMBERS AND
TRANSPLANT AND EXPERT DISEASE
PHYSICIAN, CHRISTINE WITH
EXTENSIVE EXPERIENCE IN HIV AND
TRANSPLANTATION.
AND WHAT THIS NEW SECTION DOES
IT TO PROVIDE GUIDANCE FOR ART
MANAGEMENT FOR CELL TRANSPLANT
BOTH CANDIDATES AND RECIPIENTS
EMPHASIZE THE IMPORTANCE OF
VIRAL SUPPRESSION AND EMPHASIZE
THE NEED FOR DISCIPLINARY TEAM
TO MANAGE THE COMPLEXITY OF
MULTIPLE MEDICATIONS POST
TRANSPLANT INCLUDING DRUG
INTERACTIONS OF ANTI VIRALS AND
OVERLAPPING TOXITIES AND IMPACT
ON ORGAN FUNCTION AND WE ALSO
DISCUSSED SPECIFICALLY ABOUT
DONOR WITH HELP SITES B,
HEPATITIS-C OR HIV, SO I THINK
IT'S A VALUABLE DECISION TO THE
GUIDELINES.
NEXT.
WE CHANGED OUR WHAT TO START
UPDATES IN A MAJOR WAY AND I'LL
DETAIL WHAT THOSE WERE, THE
FIRST IS VAC VEER NOW NOT
CONSIDERED AMONG THE MEMBERED
THERAPY AND THAT'S BECAUSE OF A
HOST OF FINDINGS INCLUDING THE
NEED FOR US A SPECIFIC GENETIC
TO RULE OUT THE HYPER SENSE
ITIVITY REACTION BUT ALSO
ASSOCIATE A VACAVIR AND THAT
NOW FEATURE IT AS AN
ALTERNATIVE.
SMFT OTHER REGIMENS HAVE BEEN
REMOVED.
SO WE NOW HAVE REMOVED BOTH AV
VIE, AND RAL TAGRE VIR SO
ESSENTIALLY LEAVING VICTIM, AND
TAG AND INJECTABLE BUT REMOVING
THOSE REMOVING, ADDUNSANVIR
FROM A LIST OF AND NOW THE ONLY
RECOMMENDED IS RESVIR AND ONLY
NNRTIs RECOMMENDED OUR DOVAVI
N*E AND REAL AND REMOVING THE
OLDER FORMULATION OF TENAFA DIR
T.D. F IN THE TRIPLE
COMBINATION COFORMULATION.
IN ADDITION, WE EXPANDED OUR
DISCUSSIONS WITH TREATING
PEOPLE WITH HIV WHO USED AN
INTER GRACE INHIBITOR EITHER
FOR PREP.
SO ESSENTIALLY STREAMLINING AND
EMPHASIZING THE MORE AFFECTIVE
CHOICES FOR BOTH PREFERRED AND
ALTERNATIVE REGIMEN BASED ON
DATA DRIVEN.
NEXT.
WE EXPANDED SECTIONS ON LONG
ACTING AND ADDRESSED OPTIMIZING
ART WHAT TO DO IN THE IN THE
BIOLOGIC FAILURE OR ADHERENCE.
AS YOU'RE AWARE, V EMERGING
DATA YOU GO SUGGESTING ITS USE
IN OTHER POPULATIONS WHERE IT
MIGHT BE HELPFUL INCLUDING
VIREMIC PATIENTS, SO THEY'RE
EMERGING DATA ON THAT GROUP SO.
WHAT WE WROTE FOR THAT A GROUP
IS BASED ON VERY LIMITED DATA,
THE PANEL RECOMMENDS THE USE OF
LUNG ACTING CAB ON A CASE BY
CASE BASIS.
AND SHARED DECISION MAKING--WHO
HAVE NO EVIDENCE RESISTANCE TO
CAB AND SHARED DECISION MAKING
BETWEEN PROVIDERS AND PEOPLE
WITH HIV, STI IS AN OPTIONAL
AND 3 THE LOWEST QUALITY OF
EVIDENCE THAT IS EXPERT OPINION.
BUT WE REALLY WANTED TO LEAVE
THIS OPEN FOR PEOPLE IN THIS
SCENARIO AND LOOK FORWARD TO
MORE STUDIES TO PLAYBOYING IT
MORE EVIDENCE BASE.
NEXT.
WE UPDATED A NUMBER OF OTHER
SECTIONS, AS YOU CAN SEE HERE.
SUBSTANCE USE DISORDER,
TRANSGENDER PEOPLE, ADHERENCE,
HEPATITIS B, TB COINFECTION,
DRUG RESIST NOTS TESTING AND
EARLY HIV INFECTION, WOMEN COST
CONSIDERATION, DRUG
INTERACTIONS AND WE UPDATED OUR
VOLUNTARY LUM NOUS ABLES AS
WELL.
THIS WAS THE RETREAT THAT WE
HAD SEPTEMBER 20, 2024 WAS HELD
IN THE DC AREA.
AND YOU CAN SEE WE HAD GREAT
ATTENDANCE, A LARGE GROUP OF
OUR FOLKS.
CAN WE ACKNOWLEDGE WE HAD FIVE
OUTGOING MEMBERS, DR., BROOKS,
SWINDLE AND THOMPSON AND
ACKNOWLEDGED THEIR
CONTRIBUTIONS.
NEXT, WE ALSO WELCOMED NEW
MEMBERS TO THE PANEL AS YOU CAN
SEE HERE.
DR. KNEEL--NEILAN WHO IS ON THE
CALL TODAY.
AND YOU CAN SEE THE AREA OF
EXPERTISE REALLY HELPING FILL
OUT EXPERTISE ON THE PANEL
RIGHT NOW.
NEXT.
WHAT ELSE DO WE CONSIDER AT THE
RETREAT, WE DID A REVIEW OF THE
GUIDELINES, WE LIKE TO SEE HOW
OUR GUIDELINES FIT IN WITH OR
WITHOUT WHAT PEOPLE ARE DOING.
WE HAD A VERY SPIRITED DEBATE
ABOUT WHETHER WE SHOULD DO
INTER GRACE RESISTANCE TESTING
IN ALL PEOPLE WITH HIV PRIOR TO
STARTING ART.
MELODY THOMPSON REVIEWED NEW
DRUG IN THE PIPELINE WHERE
THERE ARE MANY AND DISCUSSION
ON RESEARCH GAPS, WE ASKED ALL
THE PANEL MEMBERS WHAT DATA ARE
WE MISSING, AND I'LL SHARE THE
TOP FIVE ON THE NEXT SLIDE.
AND THEN FINALLY, WE DEVELOPED
A REVISION PLAN FOR THE NEXT
YEAR MOVING FORWARD.
NEXT.
SO WE THOUGHT IT WOULD BE
INTERESTING FOR YOU ALL TO SAY,
WELL WHAT ARE THE RESEARCH GAPS
IN ART?
WHAT DATA DO WE NEED TO BETTER
INFORM THE GUIDELINES, THESE
ARE THE TOP FIVE.
NOT A LOT OF DATA THERE, RESIST.
HOW DO WE BEST USE LONG ACTING
ART ON NON VIROLOGYCAL SUPPRESS
THED POPULATIONS.
WHAT IS THE ROLE OF GLP-1
AGONIST FOR WEIGHT LOSS AND
SUBSTANCE USE DISORDER.
AND HOW ABOUT DRUG-DRUG
INTERACTIONS.
AND LAST BUT NOT LEAST, WHAT
ARE THE LONG TERM OUTCOMES IN
SPECIAL POPULATIONS ARE HIV
INCLUDING THE PARANATAL AND
TRANSGENDER.
THIS IS MY LAST SLIDE, UPDATE
FOR CARING FOR PEOPLE DISPLACED
BY NATURAL DISASTERS ON OCTOBER
11, WE ARE WORKING ON A NEW
SECTION ON METABOLIC IN PEOPLE
WITH HIV FOLLOWING THE REPRIEVE
STUDY AND WE EARMARKED A NUMBER
OF SECTION THAT'S WE WANT TO
UPDATE AND REVISE INCLUDING
LAND MONITORING, WHEN TO START,
TREATMENT AS PREVENTION, POOR
CD4 RECOVERY AND PERSISTENT
INFLAMMATION, SO-CALLED IMMUNO
LOGIC FAILURE, ADOLESCENT AND A
ADVERSE AFFECTS.
WE HAVE A BUSY YEAR.
I THINK THAT'S MY LAST SLIDE.
>> THANK YOU, DOCTOR.
THE FINAL UPDATE WILL BE FROM
DR. FRANKLIN YATES WHO WILL
PROVIDE AN UPDATE ON PEDIATRIC
INFECTION GUIDELINES.
DR. YATES, YOU MAY BEGIN.
>> HI, EVERYBODY I'M PLEASED TO
BE HERE AND AND PRESENT OUR
BRIEF HIV GUIDELINES AND I'M
ALSO PLEASED TO DO IT WITH DR.
DONENBERG WHO IN KNOW WELL FROM
OTHER CAPACITIES.
NEXT SLIDE, SO THIS CHART
DEMONSTRATES THE CONTINUING
HIGH RATE OF PAGE VIEWS OF
THESE GUIDELINES, THE PEDS ARE
SMALLER BUT THE STABILITY OF
THESE NUMBERS SHOW HOW THESE
GUIDELINES CONTINUE TO BE
RELEVANT AND USEFUL RESOURCE
FOR PRACTITIONERS.
THIS CALENDAR YEAR REEMBARKED
ON OF RESTRUCTURING AND
REVISION PROCESS.
I THINK NEXT, SLIDE, PLEASE.
YES.
THANKS.
WE HAVE DONE AN ANALYSIS ON THE
TIMELINE OF OUR REVISIONS
PROCESS OVER THE PAST TWO
YEARS, AND FOUND THAT IT IS
BEEN TAKING TOO LONG UPWARDS OF
A YEAR TO REVISE AND FURTHER A
SECTION WE DID FURTHER ANALYSIS
ON THE NEED FOR PHARMACOLOGY AS
WELL AS EVALUATION OF OUR
SECTION FORMATTING WITH AN EYE
TO ENSURING CONSISTENCY BETWEEN
OUR OWN SECTIONS AND THOSE OF
ADULT GUIDELINES AS WELL AS
SOME EXTERNAL SOCIETY
GUIDELINES.
SO THINGS THAT WE'VE DONE IN
THE PAST YEAR, WE MAINTAINED A
RELATIONSHIP WITH OUR CDD
LIASON SO ENSURE THAT WE HAVE
CDC SUBJECT MATTER EXPERT
CONTRIBUTIONS TO SECTIONS
MOVING FORWARD.
WE HAVE A RECURRENTLY IN THE
PROCESS OF EXPANDING OUR PEDS
PANEL WHO ONLY HAS TWO
PHARMACOLOGIST TO ALLOW FOR
FOUR FORMAL FORM LOGICAL REVIEW
OF EACH SECTION AND WE HAVE
CREATED A NEW GUIDE FOR
ENSURING THAT THERE WILL BE
FORMATTING CONSISTENCY BETWEEN
OUR PEDS GUIDELINES AND ADULT
GUIDELINES AND IN SOME CASES,
GUIDELINES OF OTHER SOCIETY
EXTERNAL SOCIETIES.
NEXT SLIDE, PLEASE.
SO OUR MOST RESENT SECTION
UPDATE IS A BRAND NEW SECTION
FOR US COVID-19 SECTION, IT
DESCRIBES THE APPROACH TO
PREVENTION AND MANAGEMENT OF
COVID-19 AND CHILDREN EXPOSED
TO HIV
INCLUDES COVID-19 VACCINATION
IN CHILDREN.
AND ALSO HAS RECOMMENDATIONS
FOR THE TREATMENT OF COVID-19
FOR EN DES--R*E MDESVIR.
NEXT SLIDE PLEASE.
WE HAVE A NUMBER OF SECTIONS
THAT ARE IN THE PIPELINE FOR
THIS YEAR AND WE THOUGHT THAT
THEY MAY BE PUBLISHED BY THIS
MONTH BUT THEY'RE ACTUALLY DUE
TO BE PUBLISHED IN NOVEMBER AND
DECEMBER, SO IF I SHOULD HAVE
MORE DETAILS BY NEXT GO-AROUND
OF THIS MEETING.
BUT, IN NOVEMBER, WE DO
ANTICIPATE HEPATITIS-C,
BACTERIAL INFECTIONS AS WELL AS
IMPORTANT AND IN DECEMBER, WE
ANTICIPATE THE PUBLICATION OF
OUR VACCINE PREVENTABLE
DISEASES SECTION, HEPATITIS B
AND OUR IMPORTANT TABLES 4 AND
5 PHARMACOLOGY THOSE THAT HAVE
TO DO WITH DRUG INTERACTIONS
AND ADVERSE AFFECT.
NEXT SLIDE.
SO I BELIEVE THAT IS IT FOR MY
BRIEF UPDATE AND THANK YOU FOR
THE OPPORTUNITY TO PRESENT.
>> THANK YOU, DR. YATES.
I WANT TO CHECK IN WITH
GLENSHAW AT THIS TIME, DO WE
HAVE TIME FOR AT LEAST ONE OR
TWO QUESTIONS.
>> ABSOLUTELY, WE HAVE ABOUT 15
MINUTES.
>> OKAY, GREAT.
ANYBODY HAVE ANY QUESTIONS,
COMMENTS?
YES, DR. FLETCHER.
>> HI, I WANT TO THANK EVERY
ONE FOR THE VERY NICE UPDATE.
MY QUICK QUESTION WOULD BE FOR
DR. DHONEREDDY, I GUESS IT CAME
TO A SURPRISE THAT THE CDC DID
NOT APPOINT A DIRECTOR.
DOES THAT CREATE--.
>> SIMILAR TO THE PEDIATRIC
GUIDELINES, WE'LL STILL
CONTINUE TO HAVE GROUP MEMBERS
IN OUR SECTIONS THAT ARE FROM
THIS CDC WHAT IS ELIMINATED IS
THE CLEARANCE PROCESS BY HAVING
THE CO-CHAIR AND HAVE THE
GUIDELINES BE PART OF THE CDC
GUIDE GUELINES.
THAT PROCESS TAKES A LONG TIME
WITH ADDITIONAL TIMELY UPDATES
IN THE GUIDELINES AND I'M SURE
MY PEDIATRIC COLLEAGUES WOULD
AGREE WITH THAT.
SO I THINK THIS ACTUALLY, WE'LL
CONTINUE TO HAVE THE SAME
SUBJECT MATTER EXPERTS BUT LESS
OF THE BUREAUCRATIC CLEARANCE
PART OF THE PROCESS.
>> GREAT, THANK YOU.
>> ANYONE ELSE?
DR. MONT ANER.
>> YES, THANK YOU JUST A POINT
OF DISCUSSION FOR DR.--THANK
YOU FOR THE PROCESS.
IT'S SUCH AN IMPORTANT PIECE OF
THE NIH PORTFOLIO, THANK YOU
FOR THE LEADERSHIP AND
CONTRIBUTION OF EVERY ONE.
KIND OF LIKE I SIT IN THE
FEDERAL CLINIC BOARDS HERE IN
PHILADELPHIA AND ALSO
PARTICIPATE IN SEVERAL
INITIATIVES AND CENTER MINORITY
INSTITUTIONS AND THEIR YEARLY
MEETINGS.
AND THROUGH THESE TYPES OF
EXPERIENCES, I KIND OF LIKE
ALWAYS HAD A KIND OF DESIRE
THAT THERE WOULD BE MORE KIND
OF BRIDGES BETWEEN THE EXISTING
NETWORKS AND THESE TYPES OF
ORGANIZATIONS BECAUSE OF THEIR
OBVIOUS CONSTITUENCY THAT DEALS
WITH A LOT OF PEOPLE LIVING
WITH HIV
SO I'M JUST SORT OF APPOINT OF
OBSERVATION THAT IF THERE WOULD
BE ANY CONSIDERATIONS TO CREATE
THEIR INTENTIONAL INITIATIVE TO
TRIAL WHETHER IT BE
INCENTIVIZING TO HAVE
TMENT IN THESE SITES OR
INCORPORATE INVESTIGATORS INTO
THEIR TEAMS OR ANY SORT OF
ACTIVE OUT REACH INITIATIVE TO
CREATE MORE BRIDGES SO PEOPLE
CAN TALK AND INTERACT.
YOU HAVE SUCH A UNIQUE
OPPORTUNITY THAT YOU'RE SETTING
THE AGENDA FOR THE NEXT SEVEN
YEARS IN RELATION TO HOW THESE
NETWORKS OPERATE.
I REBT TIME WHEN THERE WERE THE
NETWORKS AND THE, THESE
INITIATIVES WERE REALLY
SUCCESSFUL IN PENETRATING
COMMUNITIES AND IT SEEMS SINCE
THAT STOPPED AND WE WENT TO THE
SCBG SITES NOW WITH THE FEDERAL
CLINICS PERHAPS THERE IS
ANOTHER OPPORTUNITY TO LOOK FOR
SOME OTHER WAYS.
I DON'T HAVE THE ANSWERS BUT I
HAVE SUCH AN OBSERVATION IF
THERE WAS AN OPPORTUNITY TO
THINK ABOUTHWHAT WE COULD TRY
TO BRIDGE, THIS WOULD BE IT.
>> YOU RAISE A VERY IMPORTANT
POINT, LUIS, I APPRECIATE THAT
A LOT.
THIS IS AN AREA OF ACTIVE
DISCUSSION.
AND THERE IS, THERE IS A LOT OF
PRESSURE ON THE CLINICAL TRIAL
UNITS AND CLINICAL TRIAL SITES.
IF THEY'RE ENGAGED IN IND LEVEL
RESEARCH THAT REQUIRES THE
INPUT OF DATA INTO TRIAL MASTER
FILE AND IT'S HEADED TOWARDS A
REGULARATRY COMPLIANCE.
IT REQUIRES A SITE TO HAVE AN
EXTENSIVE AMOUNT OF EXPERIENCE.U
SO YOU JUST CAN'T ARM ONE OF
THOSE--[INDISCERNIBLE]
A CLINICAL PROGRAM THAT PROVIDE
CARE DOES NOT MEET THAT
STANDARD AT ANY LEVEL.
SO WHEN I TALKED ABOUT THE
OTHER WAYS OF ADDING SITES, THE
THE SPECIFIC SITES, THAT IS THE
WAY IN.
IS THAT PROTOCOLS THAT HAVE ARE
IMPORTANT BUT NEED POPULATIONS
OR THERE IS A DEMONSTRATED
ABILITY FOR THOSE KINDS OF SITES
THE QUESTION IS HOW DO WE
CAPTURE THE ABILITY OR
EXPERIENCE OF SITES?
WITHOUT OVERLOADING THE REVIEW
PROCESS?
THEY DON'T HAVE THE ARTS THAT
PEOPLE NEED.
SO THAT, YOU THINK THE
ABILITY TO BRIDGE IN THE HEALTH
CENTERS WOULD BE A GREAT PLACE
TO START.
I THINK THE OTHER ISSUE ARE
THE, THE H U MEDICAL
SCHOOLS IS ANOTHER OPTION
THROUGH THE PROGRAM.
WE'VE BUILT REALLY OUTSTANDING
BRIDGE WITH H B.C. MEDICAL
SCHOOL AND I THINK THAT WOULD
BE ANOTHER PLACE THAT WE'RE,
ACTIVELY TALKING ABOUT HOW
THOSE BRIDGES COULD BE EXPANDED.
YOU KNOW, HOW IT'S A MA'SAYER I
LIKE THAT.
SO IT'S AN IMPORTANT QUESTION.
IT'S ONE THAT WE'RE ACTIVELY
TALKING ABOUT.
SO THANK YOU FOR RAISING IT.
>> YES.
>> ANY FINAL QUESTION>>
OKAY.
SEEING NO HANDS RAISED, AS WE
BEGIN TO CLOSE TODAY'S MEETING,
THIS IS THIS TIME HAS BEEN
LO--THIS TIME HAS BEEN
ALLOCATED FOR PUBLIC COMMENT.
DOCTOR GLENSHAW, HAVE YOU
RECEIVED ANY PUBLIC COMMENT FOR
TODAY'S MEETING.
>> NO, NOT TODAY.
>> OKAY.
>> I WOULD LIKE TO TAKE THIS
OPPORTUNITY TO THANK EVERY ONE
AND AGAIN TO THANK OUR TASK
FORCE CHAIRS EXECUTIVES AND
MEMBERS FOR ALL THEIR WORK.
AND FOR OUR OARAC MEMBERS
YOU'LL RECEIVE A CONFLICT OF
INTEREST FORM AT THE CLOSE OF
THE MEETING IN A FEW MINUTES
AND PLEASE SIGN AND RETURN THAT
AT YOUR EARLIEST CONVENIENCE.
PLEASE NOTE OUR NEXT MEETING IS
FEBRUARY 20.
OVER TO YOU.
>> THANK YOU, I'M SO GRATEFUL
FOR EVERY ONE WHO TOOK THE TIME
TO BE HERE TODAY.
AGAIN THANKS FOR EVERY ONE'S
HARD WORK AND PURSUITHIS
AND I WILL LEAD THAT
LEAVE IT THERE.
SO HAVE A VERY NICE REST OF
YOUR DAY AND YOUR WEEKEND.
>> AND THANK YOU, EVERY ERONE F
ENGAGING IN THIS FABULOUS
MEETING.
AND ONCE AGAIN, I WOULD LIKE TO
WELCOME DR. DONENBERG,
FLETCHER, FLORES AND MA SANTA
MARIA.
TODAY'S MEETING IS NOW
ADJOURNED.
>> THANK YOU.
>> THANK YOU, BYE BYE.
>> THANK YOU.