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