I'M MARY GLENSHAW, DESIGNATED
FEDERAL OFFICIAL OF THE AIDS
RESEARCH ADVISORY COUNCIL.
WELCOME AND THANK YOU FOR YOUR
PARTICIPATION TODAY.
A BRIEF REMIND YOU ARE OUR
COUNCIL IS GOVERNED BY
PROVISIONS OF THE FEDERAL
ADVISORY COMMITTEE ACT, FACA, AS
AMENDED WHICH SETS FORTH
STANDARDS FOR FORMATION AND USE
OF ADVISORY COMMITTEES.
MY ROLE IS TO PREPARE MEETING
AGENDAS, ORGANIZE, ATTEND,
APPROVAL COUNCIL AND
SUBCOMMITTEE MEETINGS, ADJOURNED
WHEN DETERMINED IN THE PUBLIC
INTEREST AS WELL AS CHAIR
MEETINGS WHEN DIRECTED BY NIH
DIRECTOR OR OAR DIRECTOR.
AS IN PREVIOUS MEETINGS, LET'S
GO OVER GUIDELINES FOR TODAY.
PLEASE STAY MUTED UNLESS YOU'RE
SPEAKING.
PLEASE KEEP YOUR CAMERA ON FOR
MOST OF THE MEETING, HIDE IT IF
YOU NEED TO STEP AWAY AND PLEASE
PUT IT BACK ON WHEN YOU COME
BACK.
IF YOU WOULD LIKE TO PARTICIPATE
IN DISCUSSIONS WE'LL DO THIS TWO
WAYS.
FOR FOLKS ON THE M.S. TEAMS CALL
USE THE "RAISE HAND" FEATURE SO
WE CAN SEE THAT YOU'RE READY TO
MAKE A COMMENT.
FOR THOSE IN THE ROOM, PLEASE
STAND YOUR NAME CARD UP
VERTICALLY SO I CAN RECOGNIZE
YOU.
LOWER YOUR HAND OR NAME CARD
WHEN FINISHED SO WE KNOW YOU'RE
DONE.
PLEASE USE THE CHAT FEATURE FOR
LOGISTICS MESSAGES, NOT FOR
SUBSTANTIAL PARTICIPATION.
IF YOU HAVE QUESTIONS OR
CONCERNS E-MAIL US AT
OARACINFO@NIH.GOV.
FOR FOLKS USING THE VIDEOCAST,
IF YOU'D LIKE TO USE THE CLOSED
CAPTION FEATURE, CLICK THE CC I
CON ON THE BOTTOM RIGHT-HAND
CORNER OF THE VIDEO SCREEN.
I'LL REMIND OUR MEMBERS OF OUR
POLICIES REGARDING CONFLICT OF
INTEREST.
COUNCIL MEMBERS MAY NOT
PARTICIPATE IN THE REVIEW OR
DISCUSSION OF A SPECIFIC PROGRAM
OR PROJECT FOR WHICH THEY HAVE A
REAL OR APPARENT CONFLICT OF
INTEREST.
IF A PROGRAM OR PROJECT IS
DISCUSSED THAT PRESENTS A
CONFLICT, EXCUSE YOURSELF FROM
THE MEETING.
SIGNAL ME AND WE'LL MOVE YOU TO
A SEPARATE MEETING SPACE ON
TEAMS OR IN THE ROOM.
AFTER THE MEETING KINDLY SIGN
THE ELECTRONIC CONFLICT OF
INTEREST FORM E-MAILED TO YOU
TODAY TO VERIFY NOTHING
DISCUSSED POSED A CONFLICT FOR
YOU.
BEFORE I MOVE FORWARD ARE THERE
ANY QUESTIONS ABOUT CONFLICTS OF
INTEREST?
OKAY.
HEARING NONE, PLEASE ALSO
REMEMBER TODAY'S MEETING IS OPEN
TO THE GENERAL PUBLIC, AND
CURRENTLY BEING RECORDED AND
VIDEOCAST LIVE.
I WILL NOW WELCOME OUR NEW OARIC
CHAIR, DR. MONTANER AND TURN THE
MEETING OVER.
>> GOOD AFTERNOON, EVERY ONE,
THE 68th MEETING IS NOW IN
SESSION, WELCOME, EVERYONE.
WE WILL NOW PROCEED WITH THE
ROLL CALL, DR. GLENSHAW, PLEASE
PROCEED.
>> SURE.
STANDING MEMBERS AND GUESTS,
WHEN I CALL YOUR NAME STATE YOUR
POSITION AND INSTITUTIONAL
AFFILIATION.
WE REALIZE SOME PARTICIPANTS MAY
JOIN A LITTLE BIT LATER.
WE'LL START WITH OUR VOTING
MEMBERS.
DR. COURTNEY FLETCHER.
>> PRESENT, UNIVERSITY OF
NEBRASKA MEDICAL CENTER.
>> GREAT.
THANK YOU.
DR. FLORES.
>> HI, I'M AT UNIVERSITY OF
COLORADO ANSCHUTZ MEDICAL
CAMPUS, DEPARTMENT OF MEDICINE.
>> DR. ANN NEILEN.
>> GOOD AFTERNOON, DEPARTMENT OF
PEDIATRICS, DEPARTMENT OF
MEDICINE, HARVARD MEDICAL
SCHOOL, MASSACHUSETTS GENERAL
HOSPITAL IN BOSTON.
>> WELCOME.
DR. DIANE SANTAMARIA, SCHOOL OF
NURSING, UNIVERSITY OF TEXAS
HEALTH SCIENCE CENTER, HOUSTON.
>> THANK YOU.
DR. SARAH SAWYER MIGHT BE
JOINING A LITTLE BIT LATER.
MOVING TO THE EX OFFICIOS,
CENTER JULIE AKE.
>> DIRECTOR OF THE U.S. MILITARY
HIV RESEARCH PROGRAM, WALTER
REED ARMY INSTITUTE, JOINING
FROM HAWAII, SO ALOHA.
>> ALOHA.
THANK YOU.
DR. DIEFFENBACH?
HE MIGHT BE JOINING LATER TOO.
DR. ROHAN HASRA.
>> I'M DIRECTOR OF THE DIVISION
OF EXTRAMURAL RESEARCH AT THE
NATIONAL INSTITUTE OF CHILD
HEALTH AND HUMAN DEVELOPMENT AT
NIH.
>> THANK YOU.
IT'S MY PLEASURE TO WELCOME TO
THEIR FIRST MEETING TWO NEWEST,
OH
OFFICIOS.
>> HEATHER HAWK.
>> WELCOME.
>> AND GOOD AFTERNOON, ROBIN
FANFAIR, AT CDC IN ATLANTA.
>> REPRESENTING OUR FELLOW
ADVISORY COUNCILS DR. DIANNE
RAUSCH.
>> DIANNE RAUSCH, DIRECTOR OF
THE DIVISION OF AIDS RESEARCH AT
NATIONAL INSTITUTE OF MENTAL
HEALTH.
>> AND NOW TO OAR LEADERS AND
SPEAKERS.
DR. GERI DONENBERG.
>> HELLO, DIRECTOR OF THE OFFICE
OF AIDS RESEARCH.
>> INVITED GUESTS, FROM NIH, DR.
ALICE PAU.
>> ALICE PAU, AT NIAID, NIH.
>> THANK YOU.
DR. CHACKTORA.
>> AT THE NATIONAL INSTITUTE OF
CHILD HEALTH AND HUMAN
DEVELOPMENT, PREGNANCY AND
PERINATOLOGY BRANCH.
>> DR. HENRY MASUR MIGHT BE
JOINING LATER AND HENRY YATES.
AND IF YOU'RE ON THE LINE LET US
KNOW, DR. LISA ABGO.
STATE YOUR AFFILIATION.
>> UNIVERSITY OF COLORADO,
DENVER.
>> THANK YOU.
DR. ELAINE ABRAMS.
DR. CONNIE BENSON.
DR. JOHN BROOKS.
DR. ANDREA SIARANELLO.
DR. CHIP GULIK.
>> HI, I'M HERE.
DIVISION OF INFECTIOUS DISEASES,
WEILL CORNELL, NEW YORK CITY.
>> THANK YOU.
AND DR. KARINA RODRIGUEZ.
>> I'M HERE, UNIVERSITY OF SOUTH
FLORIDA.
>> THANK YOU, WELCOME.
IS THERE ANYONE WE DID NOT
ANNOUNCE?
THERE ARE TWO PEOPLE, MY
APOLOGIES.
DR. JULIO ALBERTI.
>> HI, SENIOR SCIENCE ADVISER,
OFFICE OF AIDS RESEARCH, NIH.
>> THANK YOU.
DR. DAVID CHANG.
>> HELLO, DAVID CHANG, SENIOR
SCIENCE ADVISER, OFFICE OF AIDS
RESEARCH.
>> THANK YOU VERY MUCH.
DR. DIEFFENBACH, WELCOME.
>> GLAD TO JOIN.
>> THANK YOU.
DR. MONTANER, BACK TO YOU.
>> THANK YOU.
I FORGOT TO INTRODUCE MYSELF,
LUIS MONTANER, WISTAR INSTITUTE,
PROFESSOR.
THANK YOU FOR JOINING.
FOR OUR CHARTER AND LEGISLATION
OARAC ADVISES ON MATTERS RELATED
TO RESEARCH, PRIORITIES,
STRATEGIC PLANNING INCLUDING
REVIEW OF THE NIH AIDS PROGRAMS.
I WILL NOW PROVIDE A BRIEF
OVERVIEW OF TODAY'S AGENDA WHICH
INCLUDES TO START A REPORT FROM
THE OAR DIRECTOR, DR. GERI
DONENBERG, THEN A PRESENTATION
ON ADVANCED PLATFORMS FOR VIRAL
LOAD MONITORING, POINT OF CARE.
THEN A STRATEGY UPDATE REGARDING
THE HIV CLINICAL PRACTICE
GUIDELINES.
AND FINALLY, AN UPDATE FROM
ADVISORY COUNCIL
REPRESENTATIVES.
THE AGENDA ALSO INCLUDES TIME
FOR REGISTERED PUBLIC COMMENTS
OF WHICH THERE HAVE BEEN QUITE A
FEW SO WE'LL GET TO THEM AT THE
END.
ANYONE LISTENING TODAY WHO
WISHES TO MAKE A PUBLIC COMMENT
SHOULD E-MAIL OARACINFO@NIH.GOV,
WITH YOUR NAME, AFFILIATION, AND
A QUESTION OR COMMENT.
PLEASE SEND COMMENTS BY VISITING
THE OAR WEBSITE OR FEDERAL
REGISTRY NOTICE FOR DETAILS.
WE'LL NOW PROCEED WITH THE
DIRECTOR'S REPORT FROM DR.
DONENBERG.
>> THANK YOU VERY MUCH.
LET'S SEE.
FIRST I JUST WANT TO WELCOME
EVERYONE.
THANK YOU FOR BEING HERE.
AGAIN, APPRECIATE VERY MUCH
EVERYONE'S CONTRIBUTIONS TO
OARAC.
THIS IS MY SECOND MEETING,
OFFICIALLY.
THE FIRST MEETING I SORT OF
JUMPED IN A WEEK AFTER I STARTED
THIS POSITION.
SO I'M A LITTLE BIT MORE
FAMILIAR NOW WITH OAR THAN I WAS
THEN, AND IT'S BEEN A VERY
EVENTFUL RIDE, I WILL SAY THAT.
I WILL ALSO SAY THAT I HAVE BEEN
INCREDIBLY IMPRESSED BY THE
DEDICATION OF ALL OF THE FOLKS
WHO WORK WITH THE HIV AND AIDS
RESEARCH PORTFOLIO, INCLUDING
THE STAFF AT OAR WHO HAVE
DEMONSTRATED GREAT COMMITMENT
AND PERSEVERANCE AND KNOWLEDGE
AND SUPPORT FOR THIS PORTFOLIO
AND FOR ADVANCING THE SCIENCE.
AND I'M EXCITED TO TELL YOU A
LITTLE BIT ABOUT WHERE WE ARE
GOING IN THE FUTURE IN LARGE
PART BECAUSE SOME OF THE
PRIORITIES OF THE NEW
ADMINISTRATION FIT REALLY WELL
WITH THE OFFICE OF AIDS
RESEARCH.
I WANT TO, AGAIN, JUST STATE
THAT AS THIS GROUP MOVES
FORWARD, I'M VERY HOPEFUL OARAC
WILL GUIDANCE, THIS IS A REPORT
OUT TO YOU ABOUT DIFFERENT
ASPECTS OF WHAT WE'RE DOING BUT
I'M HOPING THAT AS WE MOVE
FORWARD WE FIND WAYS TO ALSO
BRING IN A LOT MORE COMMENTS,
ADVICE, AND GUIDANCE AND
RECOMMENDATIONS MOVING FORWARD.
SO, TODAY OARAC IS BEING HOLD
THE DAY BEFORE THE HIV --
NATIONAL HIV TESTING DAY WHICH
WAS FIRST OBSERVED ON JUNE
27th IN 1995.
IT'S A DAY TO ENCOURAGE PEOPLE
TO GET TESTED FOR HIV, TO KNOW
THEIR STATUS, GET LINKED TO CARE
AND TREATMENT.
AND THE SAME FOR THE 2025
NATIONAL TESTING DAY IS LEVEL
UP -- THE THEME IS LEVEL UP YOUR
SELF LOVE, AND CHECK YOUR
STATUS.
THE REAL EMPHASIS IS VALUE
ONESELF, SHOW COMPASSION AND
RESPECT AND HONOR OUR NEEDS WITH
SELF-LOVE.
NOW, BEFORE MOVING ON TO MY
REPORT, I WANT TO ACKNOWLEDGE,
AND I THINK MARY DID SOME OF
THIS EARLIER, THAT THERE HAVE
BEEN THE DELAYS AND DISRUPTIONS
THIS YEAR POSED A NUMBER OF
CHALLENGES WITHIN OUR RESEARCH
COMMUNITY.
WE CERTAINLY WANT TO ACKNOWLEDGE
THEIR DEDICATION AND COMMITMENT
TO THE RESEARCH EFFORT.
WE DEEPLY APPRECIATE ALSO THE
NIH STAFF AND GRANTEES WHO HAVE
NAVIGATED THIS DIFFICULT
TERRAIN.
WITH THAT IN MIND, PLEASE NOTE
THAT OAR CANNOT COMMENT ON THE
FOLLOWING SPECIFIC SITUATIONS
SUCH AS INDIVIDUAL GRANTS,
APPLICATIONS, INSTITUTIONS, OR
INVESTIGATORS.
WE CANNOT COMMENT ON PENDING OR
ONGOING LITIGATION.
INTERNAL GUIDANCE DEVELOPED TO
ENSURE ALIGNMENT WITH CURRENT
PRIORITIES AND EXECUTIVE ORDERS,
AND WE ALSO CANNOT COMMENT ON
WHETHER OPPORTUNITIES WILL BE
REOPENED OR REISSUED IN THE
FUTURE.
AND WE THANK YOU FOR YOUR
PATIENCE IN THOSE LIMITATIONS.
THERE ARE, HOWEVER, PUBLICLY
AVAILABLE RESOURCES FOR YOU TO
STAY INFORMED, AND ONE OF THESE
IS THE NIH GRANTS AND FUNDING
INFORMATION STATUS WEB PAGE
WHICH INCLUDES INFORMATION ON
LATEST CHANGES THAT AFFECT NIH
GRANTS ADMINISTRATION AND
FUNDING.
THERE IS ALSO AN HHS WEBSITE
THAT PROVIDES A LIST OF ALL
NIH'S TERMINATED GRANTS,
ALTHOUGH GIVEN THAT THIS IS A
VERY EVOLVING SITUATION, YOU
ALMOST HAVE TO CHECK BACK DAILY
TO SEE WHAT'S LISTED AND WHAT
ISN'T.
BOTH OF THESE SITES CAN BE
ACCESSED BY SCANNING THE QR CODE
SHOWN ON THE SLIDE AND I'LL
PAUSE SO YOU MAY TAKE A PICTURE
OF THOSE IF YOU WANT.
YOU'LL SEE THAT WE HAVE QUITE AN
EXCITING AGENDA, I HOPE, FOR YOU
TODAY.
AND I WANT TO THANK ALL THE
PRESENTERS FOR THEIR TIME AND
WILLINGNESS TO PRESENT HERE.
FOLLOWING MY OWN DIRECTOR'S
REPORT, WE'RE EXCITED TO HEAR A
PRESENTATION ON ADVANCED
PLATFORMS FOR HIV VIRAL LOAD
MONITORING AT THE POINT-OF-CARE
FROM DR. SHAWN MULVANEY, OF
NIH'S NATIONAL INSTITUTE OF
BIOMEDICAL IMAGING AND
BIOENGINEERING.
I'LL THEN PROVIDE A STRATEGY
UPDATE REGARDING THE HIV
CLINICAL PRACTICE GUIDELINES
WHICH MANY OF YOU HAVE COMMENTED
ON.
AND THEN THAT WILL BE FOLLOWED
BY A PRESENTATION BY DR. JULIO
ALBERTI ON THE OAR INNOVATION
PROGRAM SYMPOSIUM FOLLOWED BY
DR. DAVID CHANG WHO WILL PRESENT
ON THE EARLY CAREER INVESTIGATOR
ENGAGEMENT ACTIVITIES, WHICH HAS
BEEN VERY ACTIVE AS OF LATE.
BOTH ARE HEALTH SCIENCE
ADMINISTRATORS HERE AT OAR, AND
SO WE'RE PROUD TO FEATURE THEIR
ACTIVITIES.
WE'LL THEN HEAR UPDATES FROM THE
NATIONAL INSTITUTES OF HEALTH,
INSTITUTE OF MENTAL HEALTH,
COURTESY OF DR. DIANNE RAUSCH
AND SUMMARIZE PUBLIC COMMENTS WE
RECEIVED IN ADVANCE OF AND
DURING TODAY'S MEETING.
SO, WITH THAT, I'M GOING TO MOVE
FORWARD WITH MY DIRECTOR'S
REPORT.
AND I'M GOING TO COVER A NUMBER
OF DIFFERENT TOPICS.
FIRST THERE'S BEEN LEADERSHIP
TRANSITIONS THAT YOU MAY OR MAY
NOT BE AWARE OF, STARTING WITH
OARAC AND THEN NIH AND AT THE
DPCPSI LEVEL, DPCPSI IS THE
DIVISION THAT OAR SITS IN, IN
THE OFFICE OF THE DIRECTOR.
I'LL PROVIDE UPDATES ON THE
PROPOSED NIH REORGANIZATION AND
RESEARCH -- AND NIH RESEARCH
BUDGET.
I'LL REVIEW THE PRIORITIES THAT
HAVE BEEN SET FORTH BY THE NEW
NIH DIRECTOR AS WELL AS
OPPORTUNITIES FOR OAR TO HELP
ADDRESS THESE PRIORITIES.
I'LL UPDATE YOU ON SOME
ENCOURAGING NEWS WHICH YOU MAY
KNOW ABOUT REGARDING LONG-ACTING
HIV PREVENTION, AND I'LL PROVIDE
AN UPDATE ON THE NIH STRATEGIC
PLAN FOR HIV AND HIV-RELATED
RESEARCH THAT MANY OF YOU HAVE
CONTRIBUTED HOURS AND LOTS OF
KNOWLEDGE AND SUPPORT FOR.
I'LL RECAP OAR'S KEY ENGAGEMENTS
SINCE WE LAST MET WITH YOU AND
PREVIEW UPCOMING ACTIVITIES AND
EVENTS.
AT THE OARAC LEVEL JOIN ME IN
WELCOMING DR. LUIS MONTANER AS
THE NEW CHAIRPERSON, I LOOK
FORWARD TO YOUR LEADERSHIP AND
CONTINUED CONTRIBUTIONS.
MANY THINGS FOR YOUR WILLINGNESS
TO SERVE IN THIS LEADERSHIP
POSITION.
AND THEN ON BEHALF OF OAR AND
OARAC A SPECIAL THANK YOU TO DR.
IVY TURNBULL, OARAC CHAIRPERSON
FROM 2023 UNTIL EARLIER THIS
YEAR.
YOUR COMMITMENT TO THE COUNCIL,
TO OAR, AND TO THE NIH HIV
RESEARCH ENTERPRISE IS GREATLY
APPRECIATED.
AND I LOOK FORWARD TO OUR
CONTINUED ENGAGEMENT.
MARY DID THIS EARLIER BUT I
WOULD LIKE TO ALSO WELCOME TWO
NEW EX OFFICIO MEMBERS TO OARAC,
WHICH INCLUDES CAPTAIN ROBIN
NEBLET FANFARE, REPRESENTING
CDC, AND HEATHER HAUCK, THANK
YOU BOTH FOR JOINING AND IN
ADVANCE FOR YOUR CONTRIBUTIONS.
SO MOVING TO NIH, MANY OF YOU
MAY KNOW ALREADY THERE HAVE BEEN
A NUMBER OF TRANSITIONS AT THE
ICO LEADERSHIP LEVEL SINCE WE
LAST MET.
AND THESE INCLUDE A NUMBER OF
NEW ACTING DIRECTORS LISTED ON
THIS SLIDE.
DR. CORTI AKLIN AT NATIONAL
INSTITUTE OF NURSING RESEARCH,
DR. ALISON CERNICH, EUNICE
KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH AND
HUMAN DEVELOPMENT.
DR. MONICA WEBB HOOPER AT
NATIONAL INSTITUTE ON MINORITY
HEALTH AND HEALTH DISPARITIES.
DR. ANDREA BECKEL-MITCHENER AT
MENTAL HEALTH, DR. JEFF
TAUBENBERGER, AND DR. CAROLYN
HUTTER, NATIONAL HUMAN GENOME
RESEARCH INSTITUTE AND WE THANK
THEM FOR STEPPING INTO THESE
ROLES AT THIS TIME.
FINALLY THERE HAS BEEN SOME
LEADERSHIP CHANGES IN OUR
DIVISION, THE NIH DIVISION OF
PROGRAM COORDINATION PLANNING
AND STRATEGIC INITIATIVES, WE
CALL DPCPSI, WHICH IS WITHIN THE
NIH OFFICE OF THE DIRECTOR.
THE NIH DIVISION WITHIN WHICH
OAR RESIDES.
DR. NICOLE KLEINSTREUER NAMED
ACTING DPCPSI DIRECTOR, SHE
REPLACES DR. TARA SCHWETZ.
TWO ACTING DIRECTORS NAMED FOR
OFFICES WITHIN DPCPSI, DR.
VIVIAN OTA WANG IS THE ACTING
DIRECTOR OF THE OFFICE OF
STRATEGIC COORDINATION.
AND MS. CINDY CAUGHMAN, ACTING
DEPUTY DIRECTOR, OFFICE OF
RESEARCH ON WOMEN'S HEALTH.
OKAY.
TURNING NOW TO NIH'S
ORGANIZATION, THE HIV RESEARCH
BUDGET.
SO, YOU HAVE LIKELY HEARD, I
WANT TO ALSO PUT A SHOUT OUT TO
MY COLLEAGUE, CARL DIEFFENBACH,
FOR SLIDES THAT I ADOPTED FROM
HIS PRESENTATION TO THE ACTG
NETWORK RECENTLY.
AND THIS IS ONE OF THEM.
YOU'VE LIKELY HEARD ABOUT THE
PROPOSED NIH REORGANIZATION.
THIS SLIDE DEPICTS WHAT THE NEW
ORGANIZATION WOULD LOOK LIKE.
IT COMES FROM THE HHS BUDGET IN
BRIEF FOR FISCAL YEAR 2026.
ON THE LEFT SIDE SHOWS THE 19
NIH INSTITUTES IN THEIR CURRENT
STRUCTURES, YOU'RE FAMILIAR
LIKELY WITH THAT.
ON THE RIGHT SIDE IT SHOWS THE
PROPOSED REORGANIZATION INTO
EIGHT INSTITUTES.
IT PRESERVES THE NATIONAL CANCER
INSTITUTE, NATIONAL INSTITUTE ON
AGING, AND NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS DISEASES
ON ITS OWN AS UNIQUE
INSTITUTIONS, THE OTHERS COMBINE
INTO THE INSTITUTES THAT YOU SEE
HERE.
IN TERMS OF BUDGET UPDATES, FOR
FISCAL YEAR 2025, YOU MAY KNOW
THAT THE FEDERAL GOVERNMENT
CONTINUED TO OPERATE UNDER A
FULL YEAR CONTINUING RESOLUTION.
THE PRESIDENT'S BUDGET THAT WAS
RELEASED FOR FISCAL YEAR 2026
REDUCES THE NIH BUDGET FROM $48
BILLION TO $27 BILLION.
AND IT CONSIDERS THE
REORGANIZATION THAT WE SHOWED ON
THE PREVIOUS SLIDE.
THIS LEVEL OF FUNDING WOULD
RETURN NIH TO THE ALLOCATION IT
RECEIVED IN FISCAL YEAR 2003.
CONGRESS, OF COURSE, CONTINUES
TO DEBATE AND DELIBERATE ON THE
FISCAL YEAR 2026 BUDGET.
SO WE DON'T KNOW WHAT THE FINAL
BUDGET WILL BE.
AND IT WILL BE JOINT DISCUSSION
AMONG THEM AND I'M SURE AS WELL
AS WITH THE PRESIDENT IN
NEGOTIATIONS.
EACH YEAR OAR PREPARES A
CONGRESSIONAL BUDGET
JUSTIFICATION.
WE USE THE NUMBERS THAT THE
PRESIDENT'S BUDGET OUTLINES.
FISCAL YEAR 26 CJ WAS RELEASED A
FEW WEEKS AGO, AND IS AVAILABLE
ON OUR WEBSITE.
YOU CAN SCAN THE QR CODE FOR A
COPY OF THE CJ.
IT'S ALSO INCLUDED IN BRIEFING
MATERIALS YOU RECEIVED.
THE FISCAL YEAR 26 CJ IS
ORGANIZED BASED ON PROPOSEED
STRUCTURE.
THE TABLE MAY BE DIFFICULT TO
READ BUT IT APPEARS ON PAGE 4 OF
THE C.J. DOCUMENT.
THE TABLE ON THIS SLIDE SHOWS IN
COLUMNS THE FINAL 2024
ALLOCATION, FISCAL YEAR 2024, IT
ALSO SHOWS THE 2025 ALLOCATION
UNDER THE CONTINUING CURRENT
CONTINUING RESOLUTION, AND THEN
IT PROVIDES WHAT THE ALLOCATION
WOULD BE UNDER THE PROPOSED 2026
PRESIDENT'S BUDGET.
SO THAT THE FAR RIGHT COLUMN
SHOWS DIFFERENCE BETWEEN THE
FISCAL YEAR 2025 FUNDED LEVELS
AND THE PROPOSED PRESIDENT'S
BUDGET.
IT SHOWS A NEARLY $1.4 BILLION,
OR 42%, REDUCTION IN TOTAL NIH
HIV FUNDING PROPOSED IN THE
PRESIDENT'S BUDGET FOR THE NEXT
FISCAL YEAR.
AGAIN, I WANT TO REITERATE THIS
IS A PROPOSAL.
AND CONGRESS WILL DETERMINE THE
FINAL BUDGET FOR THIS YEAR.
SO WITH THAT I'M GOING TO TURN
TO THE OVERVIEW OF THE NIH
PRIORITIES AND THE OAR'S
OPPORTUNITIES TO HELP ADVANCE
THESE PRIORITIES.
SO MANY OF YOU KNOW THAT DR. JAY
BHATTACHARYA HAS BEEN APPOINTED
NEW DIRECTOR OF THE NATIONAL
INSTITUTES OF HEALTH.
AND HE HAS OUTLINED A NUMBER OF
PRIORITIES THAT HE WOULD LIKE TO
SEE MOVE FURTHER IN THE NIH
PORTFOLIO.
ONE IS TO IMPROVE POPULATION
HEALTH.
NIH MUST -- AND HE DEFINES THIS
AS ADDRESSING THE HEALTH NEEDS
OF THE AMERICAN PEOPLE AND
FINDING BETTER WAYS TO PREVENT,
TREAT, AND CURE CHRONIC
DISEASES.
THE SECOND AREA OF PRIORITY IS
TO ENSURE RELIABLE RESULTS, AND
IN THAT WAY HE WANTS
NIH-SUPPORTED SCIENCE TO BE
REPRESENT LIABLABLE,
REPRODUCIBLE, GENERALIZABLE.
THIRD PRIORITY TO MAKE BIG
ADVANCES, HE WANTS NIH TO INVEST
IN INNOVATION, EMBRACE NEW
TECHNOLOGIES, NEW IDEAS, AND NEW
APPROACHES TO OLD PROBLEMS.
THE FOURTH AREA OF PRIORITY IS
TO MAINTAIN SAFETY AND
TRANSPARENCY.
AND WITH THIS HE STATES THAT THE
RESEARCH SHOULD MEET THE HIGHEST
ETHICAL STANDARDS AND SHOULD NOT
ENDANGER HUMAN POPULATIONS.
AND THEN FINALLY, HIS FIFTH
PRIORITY IS TO ENCOURAGE
ACADEMIC FREEDOM.
AND IN THIS WAY, HE STATES THAT
NIH WILL FOSTER A CULTURE IN
WHICH SCIENTISTS CAN EXPRESS
DISAGREEMENT RESPECTFULLY.
WITHIN DR. BHATTACHARYA'S
FRAMEWORK OF PRIORITIES, OAR IS
VERY WELL POSITIONED TO OVERSEE
AND COORDINATE COMPREHENSIVE,
COMPLEX NIH HIV RESEARCH
PORTFOLIO.
WHILE AT THE SAME TIME WORKING
TO IDENTIFY NEW RESEARCH
OPPORTUNITIES, ADDRESS
CHALLENGES, INCREASE EFFICIENCY,
PROMOTE INNOVATION, FACILITATE
COLLABORATIVE SCIENCE, ENSURE
RIGOR AND REPRODUCIBILITY.
I'D LIKE TO HIGHLIGHT THREE
AREAS IN WHICH OAR SEES GREAT
OPPORTUNITIES TO ENHANCE OUR
EFFORTS IN WAYS THAT ALIGN WITH
OUR UNDERSTANDING OF THE STATED
PRIORITIES OF DR. BHATTACHARYA
AND THE NEW ADMINISTRATION.
FIRST, HOW BEST TO PROMOTE DATA
HARMONIZATION, OR COMMON DATA
ELEMENTS.
I RECENTLY PUBLISHED A PAPER ON
THE BENEFITS OF DATA
HARMONIZATION, WHICH I SEE AS
BUILDING CONSENSUS ON A SET OF
COMMON DATA ELEMENTS THAT CAN BE
USED TO IMPROVE COMPARISONS
ACROSS STUDIES.
IT WILL ALSO PERMIT SECONDARY
DATA ANALYSES BY BOLSTERING
RIGOR AND REPRODUCIBILITY AND
INCREASING THE RETURN ON NIH
INVESTMENT.
SECOND, WE'D LIKE TO FOCUS ON
SUSTAINING EVIDENCE-BASED
INTERVENTIONS.
WHEN WE FIND SOMETHING THAT
WORKS, WE NEED TO WORK WITH OUR
FEDERAL, STATE, AND LOCAL
PARTNERS TO SUSTAIN IT.
THE ENDING THE HIV EPIDEMIC WAS
AN EXAMPLE OF WORKING WITH
COMMUNITY PARTNERS TO ENSURE
SUSTAINABILITY OF EFFECTIVE
INTERVENTIONS AND TOOLS.
LASTLY, WE'D LIKE TO EMPHASIZE
IMPLEMENTATION RESEARCH ENSURING
ALL AMERICANS BENEFIT FROM NIH'S
INVESTMENTS BY CLOSING THE GAP
BETWEEN AN INNOVATIVE DISCOVERY
AND APPLYING IT IN THE REAL
WORLD.
SORRY, THERE'S LIKE A FLY THAT
KEEPS COMING IN FRONT OF ME LIKE
A GNAT, IF YOU SEE ME DOING
THIS.
THIS REQUIRES RIGOROUS STUDY OF
FACTORS THAT WILL IMPROVE REACH,
ACCEPTABILITY, FEASIBILITY,
ADOPTION, FIDELITY,
SUSTAINABILITY.
SO TAKING ADVANTAGE OF THESE
FUTURE OPPORTUNITIES WILL
REQUIRE AN EMPHASIS ON
IMPLEMENTATION SCIENCE.
AS AN EXAMPLE, CDC SURVEILLANCE
DATA ESTIMATES 1 IN 8 AMERICANS
WITH HIV DO NOT KNOW THEIR
STATUS.
WE NEED IMPLEMENTATION SCIENCE
TO UNDERSTAND HOW BEST TO
IMPROVE UPTAKE AND ADOPTION OF
EVIDENCE-BASED TESTING IN THE
INTERVENTION TO CLOSE THIS GAP.
IN FACT, THERE IS A
WELL-ESTABLISHED 17-YEAR GAP
BETWEEN DISCOVERY AND WHEN IT
GETS USED IN PRACTICE.
EVEN THEN, FEWER THAN HALF OF
EVIDENCE-BASED INTERVENTIONS
EVER MAKE IT INTO PRACTICE.
IMPLEMENTATION SCIENCE SEEKS TO
CLOSE THIS GAP BY SPECIFYING
STEPS IN BETWEEN DEVELOPMENT OF
THE INNOVATION AND ITS
APPLICATION IN REAL LIFE.
SO IN OTHER WORDS IMPLEMENTATION
RESEARCH STUDIES THE WHY, WHAT,
WHEN, WHERE, AND WHO.
WHY AREN'T AMERICANS GETTING
TESTED FOR HIV?
WHAT STRATEGIES WILL OPTIMIZE
HIV TESTING?
WHEN SHOULD HIV TESTING BE
OFFERED TO MAXIMIZE UPTAKE?
WHERE SHOULD HIV TESTING BE
PROVIDED TO STRENGTHEN UPTAKE?
AND WHO SHOULD CONDUCT THE
TESTING TO ACHIEVE THE GREATEST
REACH?
I'M PLEASED TO LEARN THAT THE
NIH LEADERSHIP SHARES MY
APPRECIATION FOR THE IMPORTANCE
OF IMPLEMENTATION SCIENCE, AND
THEY HAVE REQUESTED A GREATER
EMPHASIS IN THIS AREA OF
RESEARCH.
OAR IS ACTIVELY MEETING WITH NIH
INSTITUTES AND CENTER DIRECTORS,
WITH HIV RESEARCH IN THEIR
PORTFOLIOS, TO DISCUSS THEIR
RESPECTIVE INTERESTS, CURRENT
ACTIVITIES, AND AVAILABLE
EXPERTISE RELATED TO
IMPLEMENTATION SCIENCE AND HIV.
I WILL ALSO BE WORKING WITH THEM
TO DEFINE AVAILABLE FUNDS FOR
EXPANDING IMPLEMENTATION SCIENCE
IN HIV RESEARCH.
WORKING WITH THE INSTITUTES, WE
WILL DEVELOP RECOMMENDATIONS,
DEFINE LEVELS OF SUPPORT,
IDENTIFY WAYS TO STRENGTHEN HIV
IMPLEMENTATION SCIENCE, CONVENE
CROSS-NIH PANELS, TO MAP
PATHWAYS FOR FACILITATING HIV
IMPLEMENTATION SCIENCE RESEARCH
AND SUPPORT.
AND THEN FINALLY WE PLAN TO
EXPAND CROSS-ICO COLLABORATIONS
TO DEVELOP A BROAD PROGRAM OF
HIV IMPLEMENTATION SCIENCE,
ENGAGING COMMUNITIES AT THE
CENTER AND OTHER PARTNERS.
THE GOAL IS TO CREATE INCLUSIVE
CROSS-INSTITUTE AND CENTER
FUNDING OPPORTUNITIES TO FOSTER
IMPLEMENTATION SCIENCE TO END
THE HIV EPIDEMIC.
ANOTHER EXAMPLE OF OAR
APPROACHES TO TAKE ADVANTAGE OF
FUTURE OPPORTUNITIES SHOWN A FEW
SLIDES AGO IS THROUGH NIH-WIDE
INITIATIVES DESIGNED TO CATALYZE
SCIENCE.
SHOWN ON THIS SLIDE ARE OUR FIVE
CURRENT FOCUS AREA THAT AIM TO
STIMULATE AND SUPPORT
INTERDISCIPLINARY RESEARCH AND
TRAINING TO MEET THE NEEDS OF
PEOPLE WITH AND IMPACTED BY HIV.
EACH OF THE PROGRAMS CONVENES
STAKEHOLDERS, PRODUCES
SCIENTIFIC WORKSHOP AND
DATA-DRIVEN FUNDING
OPPORTUNITIES.
MANY OF YOU HAVE BEEN
PARTICIPANTS AND CONTRIBUTORS TO
THESE PROGRAMS, AND WE'RE
GRATEFUL FOR YOUR ENGAGEMENT.
OAR IS CONGRESSIONALLY MANDATED
AS YOU KNOW TO MONITOR THE HIV
RESEARCH PORTFOLIO TO ENSURE IT
IS ALIGNED WITH THE STRATEGIC
PLAN.
TO DO SO, OAR STAFF BUILT A
ROBUST ANALYTICS PLATFORM THAT
SYNTHESIZES EXISTING HIV PUBLIC
DATA.
THE NIH OAR DATA HUB IS
AVAILABLE TO THE PUBLIC, AND
ENABLES RESEARCHERS TO IDENTIFY
HIV-RELATED AWARDS RELEVANT TO
THEIR SPECIFIC INTERESTS,
ESPECIALLY EARLY STAGE
INVESTIGATORS.
THE DATA HUB INCREASES
UNDERSTANDING OF THE RESEARCH
THAT WE DO, ENHANCES
TRANSPARENCY AND ACCOUNTABILITY,
HELPS DISSEMINATE HIV RESEARCH
INFORMATION, AND IT SERVES AS
ANOTHER EXAMPLE OF OUR EFFORTS
TO ALIGN WITH NIH'S CURRENT
PRIORITIES.
TURNING NOW TO A BRIEF UPDATE ON
LONG-ACTING HIV PREVENTION, THIS
IS A VERY EXCITING DEVELOPMENT I
THINK FOR ALL OF US.
WE DID DISCUSS AT THE LAST
MEETING HOW DECADES OF
INVESTMENT IN NIH RESEARCH
SUPPORTED THE FOUNDATIONAL
DISCOVERIES THAT LED TO THE
DEVELOPMENT OF LENACAPAVIR.
RECENT CLINICAL TRIALS
DEMONSTRATED IT IS REMARKABLY
EFFECTIVE FOR HIV PREVENTION.
IN ONE PROMISE STUDY, WOMEN WERE
100% PROTECTED IN SOUTH AFRICA
IN UGANDA, ADOLESCENT GIRLS AND
YOUNG WOMEN 16-25 YEARS OLD.
IN ANOTHER STUDY, IT WAS
DEMONSTRATED ACROSS -- OH, OKAY.
ACROSS SEVEN COUNTRIES, ABOUT
96% ADHERENCE -- PROTECTION
AGAINST HIV.
IN OTHER WORDS, 99.9% OF
PARTICIPANTS REMAINED HIV
NEGATIVE FOLLOWING TWO
INJECTIONS ANNUALLY.
IMPRESSIVELY THE JOURNAL
"SCIENCE" HAILED LENCAPAVIR AS
THE 2024 BREAKTHROUGH OF THE
YEAR.
NOTING THAT NIH-SUPPORTED BASIC
RESEARCH ADVANCES REGARDING THE
STRUCTURE AND FUNCTION OF THE
HIV CAPSID PROTEIN COULD
INCLUDES THE UNDERSTANDING OF
OTHER VIRAL CAPSID INHIBITORS TO
POTENTIALLY FIGHT OTHER VIRAL
INFECTIONS.
AND LAST WEEK WAS A HUGE
MILESTONE IN THAT THE FOOD AND
DRUG ADMINISTRATION APPROVED
LENCAPAVIR FOR HIV PREVENTION.
THIS GROUNDBREAKING INTERVENTION
HAS THE POTENTIAL TO CHANGE THE
COURSE OF THE HIV PANDEMIC, AS
LONG AS WE CAN ADDRESS ACCESS,
ACCEPTABILITY, DELIVERY
MESSENGERS AND OTHER
IMPLEMENTATION-RELATED CONCERNS.
I'M ALMOST DONE BUT I WOULD LIKE
TO PROVIDE A LITTLE UPDATE ON
THE STRATEGIC PLAN THAT IS
ORGANIZED AND PRODUCED BY OAR
FOR HIV AND HIV-RELATED
RESEARCH.
WE DISCUSSED IN THE LAST MEETING
WE WERE IN THE FINAL STAGES
DEVELOPING THE 2026-2030 NIH
STRATEGIC PLAN.
AND WE'LL SHARE IT WITH YOU IN
THE COMING MONTHS.
THE NEW PLAN HIGHLIGHTS HIV
RESEARCH OPPORTUNITIES ACROSS
THE RESEARCH CONTINUUM, STARTING
WITH FUNDAMENTAL BASIC SCIENCE
ALL THE WAY THROUGH
IMPLEMENTATION RESEARCH.
AND AT EACH OF THOSE PHASES,
STRENGTHENING CAPACITY TO
CONDUCT RESEARCH IN THESE AREAS.
SO, JUST AS A QUICK RECAP OF THE
STEPS THAT WENT INTO DEVELOPING
THE PLAN, WE RECEIVED FEEDBACK
AND INPUT FROM MULTIPLE INTERNAL
AND EXTERNAL SOURCES, INCLUDING
A PUBLIC REQUEST FOR INFORMATION
THAT WAS SUMMARIZED BY OAR INTO
A FRAMEWORK THAT WAS THEN
REVIEWED AND DELIBERATED BY OUR
THREE EXPERT TASK FORCES
REPRESENTED HERE.
AGAIN, I'D LIKE TO THANK THE
TASK FORCE LEADERSHIP AS WELL AS
THE TASK FORCE MEMBERS FOR ALL
OF THEIR HARD WORK.
AND THAT BRINGS US WHERE WE ARE
TODAY IN THE PROCESS.
OARAC RECEIVED REPORT-OUTS FROM
TASK FORCES AND PUT
RECOMMENDATIONS FORWARD TO ME.
INSTITUTES AND CENTERS HAVE SEEN
THESE RECOMMENDATIONS AND
PROVIDED INPUT ON THE STRATEGIC
PLAN AS WELL.
I'VE GIVEN MY FINAL REVIEW OF
THE PLAN, AND IT IS CURRENTLY
UNDERGOING INTERNAL NIH REVIEW
AND CLEARANCE.
WE WILL SEND THE PLAN TO OARAC
MEMBERS FOR NOTATIONAL VOTE
BEFORE RELEASING IT PUBLICLY
LATER THIS YEAR.
SO BEFORE CONCLUDING I'LL JUST
NOTE A FEW RECENT AND UPCOMING
OAR ENGAGEMENTS.
MUCH HAS HAPPENED SINCE WE MET
LAST OCTOBER.
AND WHILE THERE ISN'T ENOUGH
TIME TO DISCUSS EVERY OAR
ENGAGEMENT I'LL HIGHLIGHT AND
TOUCH ON A FEW.
SO, EACH YEAR OAR LEADS THE
ANNUAL NIH OBSERVANCE OF WORLD
AIDS DAY, AND THIS YEAR WE LED A
VIRTUAL EVENT DECEMBER 4 THAT
WAS VERY WELL RECEIVED.
I WAS JOINED BY FELLOW PANELIST
FRANCISCO RUIZ AND OTHERS.
THIS AND RELATED EVENTS WERE
WELL ATTENDED AND OFFERED TIME
TO CELEBRATE BREAKTHROUGHS IN
HIV RESEARCH AS WELL AS A CHANCE
TO ACKNOWLEDGE THE NEED TO
ACCELERATE SCIENTIFIC PROGRESS
AND ENSURE THAT THOSE WITH AND
AFFECTED BY HIV HAVE THE CHANCE
TO INFORM AND PARTICIPATE IN
RESEARCH AND EXPERIENCE THE
LIFE-CHANGING IMPACT OF RESEARCH
INNOVATIONS.
WE ALSO VERY SADLY PAID TRIBUTE
TO MANY HEROES IN THE HIV
COMMUNITY WHO WERE LOST
INCLUDING LONGTIME OAR ADVISER
MR. CORNELIUS BAKER.
LOOKING AHEAD, THE 13th IAS
CONFERENCE ON HIV SCIENCE WILL
BE HAPPENING NEXT MONTH IN JULY
IN RWANDA.
I WILL BE IN ATTENDANCE,
REPRESENTING NIH OAR.
IN ADDITION TO RESEARCH-BASED
PRESENTATIONS IAS 2025 WILL
ADDRESS THE CURRENT POLITICAL
AND FINANCIAL ISSUES AFFECTING
THE HIV RESPONSE, INCLUDING
IMPLICATIONS FOR AFRICA AND
GLOBALLY.
THE 2025 U.S. CONFERENCE ON
HIV/AIDS WILL BE HELD IN
WASHINGTON, D.C. THIS YEAR IN
EARLY SEPTEMBER FROM THE 4th
TO 7th.
THE OVERALL THEME OF USCHA IS
AGING WITH HIV AND OAR WILL BE
PARTNERING WITH MULTIPLE NIH
INSTITUTES AND CENTERS AS WELL
AS HIV COMMUNITY LEADERS TO
FACILITATE THREE INTERACTIVE
SESSIONS.
ONE IS FOCUSED ON COMORBIDITIES,
ONE FOCUSED ON MENOPAUSE AND
WOMEN WITH HIV, AND A THIRD IS
FOCUSED ON VIRAL LOAD MONITORING
WHICH WE'LL HEAR MORE ABOUT
AFTER MY REPORT.
YOU'LL HEAR MORE ABOUT OTHER
CURRENT ACTIVITIES, INCLUDING
OUR NEXT INNOVATION PROGRAM
SYMPOSIUM, AND A NUMBER OF
ENGAGEMENTS RELATED TO EARLY
CAREER INVESTIGATORS LATER IN
TODAY'S PROGRAM FROM DR. ALBERTI
AND CHANG.
SO BEFORE CLOSING, I'D LIKE TO
THANK COUNCIL MEMBERS FOR
LISTENING TO ME TALK FOR A VERY
LONG TIME.
AND MAKING THESE MEETINGS A
PRIORITY.
IF YOU HAVEN'T DONE SO ALREADY,
PLEASE MARK YOUR CALENDARS FOR
OUR NEXT OARAC MEETING, ON
SEPTEMBER 18th.
AND THIS DATE COINCIDES WITH THE
OBSERVANCE OF NATIONAL HIV/AIDS
AND AGING AWARENESS DAY WHICH
TIES IN NICELY WITH THE UPCOMING
THEME FOR THE MEETING.
AND WITH THAT, THAT CONCLUDES MY
DIRECTOR'S REPORT.
THANK YOU FOR YOUR ATTENTION.
LUIS, I'LL TURN IT BACK TO YOU.
>> THANK YOU, DR. DONENBERG.
THANK YOU FOR THE OVERVIEW ON
THE UPCOMING OPPORTUNITIES FOR
THE STRATEGIC PLAN AND
PRIORITIES THAT OARAC MAY HAVE
THE OPPORTUNITY TO CONTRIBUTE
ADVICE ON.
SO, WE'RE GOING TO MOVE INTO
OPEN DISCUSSION NOW, TAKING ANY
POINTS FROM MEMBERS VIRTUALLY
AND PERSONS IN THE ROOM.
SO IF YOU'RE VIRTUAL AND VOTING
OR A MEMBER PLEASE RAISE YOUR
HAND.
WE'LL START WITH THE ROOM.
FIRST I'LL TAKE THE CHAIR'S
PRIORITIES AND ASK THE FIRST
QUESTION.
DR. DONENBERG, REGARDING THE
BUDGET THAT WAS PROPOSED BY YOUR
OFFICE FOR SORT OF WITHIN THE
PRESIDENT'S BUDGET, DO YOU
ANTICIPATE OR PLAN FOR KEEPING
PROPORTIONALLY AMOUNTS THAT
WOULD OTHERWISE BE CONSOLIDATED?
TAKE NIDA, THE BUDGET NIDA HAD,
IS IT LIKE MOVED INTO THE
CONSOLIDATED OR WERE THERE ANY
OTHER KIND OF CHANGES DONE ONCE
THAT CONSOLIDATION AND BUDGET
WAS MADE, TRYING TO SEE WHAT
POSITION YOUR OFFICE TOOK.
>> THE BUDGET OFFICE INVITED
INSTITUTES INDIVIDUAL THROW
REPORT OUT HOW THEY WOULD
PROPORTION THE 40% CUT ACROSS
THEIR SPECIFIC INSTITUTES.
AND SO, WE DIDN'T CHANGE THAT.
WE JUST WORKED WITH WHAT EACH
INSTITUTE SAID.
BUT I AM VERY PROUD TO SAY THAT
EVERY -- THAT THEY WERE ALSO
ASKED TO HYPOTHESIZE, THIS IS IN
NO WAY FOR SURE, BUT HYPOTHESIZE
IF THE AIDS ALLOCATION WERE
INCLUDED IN THE BASE OF THEIR
TYPICAL NIH FUNDING HOW WOULD
THEY APPORTION THEIR FUNDS FOR
HIV?
AND ALL OF THE INSTITUTES
RETAINED A STRONG COMMITMENT TO
RESEARCH IN HIV, EVEN WITH THE
40% CUT.
SO, THAT'S REALLY GREAT NEWS.
SHOWS A REAL COMMITMENT ON THE
PART OF ALL THE INSTITUTES.
>> THANK YOU.
WE'LL START WITH COMMENTS IN THE
ROOM.
ARE THERE COMMENTS IN THE ROOM
BEFORE WE GO TO VIRTUAL?
>> NOT AT THIS TIME.
>> THANK YOU.
I SEE ONE HAND RAISED.
I BELIEVE DR. NEILAN.
>> THANKS SO MUCH.
I WANT TO START BY ACKNOWLEDGING
MY APPRECIATION FOR YOUR
ACKNOWLEDGMENT OF CURRENT
CHALLENGES FACING THE FIELD AND
HIGHLIGHTING OPPORTUNITIES TO
ADVANCE HIV SCIENCE.
I'M THINKING ABOUT THE CURRENT
BUDGET.
AND MY ROLE AS A VOTING OARAC
MEMBER.
I WONDER IF OAR HAS AN
OPPORTUNITY TO PROVIDE FEEDBACK
ON THE SUBSTANTIVE THREAT THAT
THE LACK OF RELEASE OF MANY OF
THE CURRENT FUNDS, THINKING
ABOUT THE CURRENT FUNDS, ARE FOR
DESTABILIZING THE WORKFORCE AND
SORT OF THE, AS YET TO MY
KNOWLEDGE, NO TIMELINE OR
GUIDANCE BEING RELEASED,
WONDERING HOW OAR IS ABLE TO
PROVIDE FEEDBACK ON THAT.
THANK YOU.
>> IT'S A GOOD QUESTION.
SOMETHING THAT I THINK ABOUT A
LOT.
AND I THINK ABOUT IN TERMS OF
WHAT AM I KIND OF ABLE TO DO AND
WHAT AM I NOT ABLE TO DO.
I CERTAINLY FOLLOW ALL OF THE
INFORMATION THAT'S COMING
FORWARD, PROBABLY AS MUCH AS YOU
DO.
AND YOU MIGHT EVEN GET THAT
INFORMATION BEFORE US.
AND TO BE HONEST I'M ALWAYS
CHECKING WITH MY COLLEAGUES
ABOUT WHAT AM I ALLOWED TO SEND
OUT TO SHARE.
AND THE TRUTH IS WE'RE NOT
ALLOWED TO COMMENT ON ANY OF
THOSE ISSUES.
AND, HOWEVER, WE SIT IN MEETINGS
AND THERE ARE DEFINITELY
OPPORTUNITIES WITHIN THOSE
MEETINGS TO EXPRESS CONCERN
ABOUT HOW THE VARIOUS SITUATIONS
ARE IMPACTING THE SCIENCE, THE
FUTURE OF THE SCIENCE,
INVESTIGATORS, AND SO FORTH.
WE ARE ABLE TO DO THAT
INTERNALLY.
>> THANK YOU SO MUCH.
>> AND WE DO.
SO --
>> ANY OTHER QUESTIONS OR
COMMENTS?
YES, I SEE ANOTHER HAND UP.
GO AHEAD.
>> HI.
THIS IS LISA.
THANKS FOR OUTLINING THE CURRENT
SITUATION.
I WAS WONDERING HOW
INTERNATIONALLY RESEARCH FITS
INTO THE PLANS AND PRIORITIES
FOR OFFICE OF AIDS RESEARCH
GOING FORWARD AND WHAT THIS
COMMITTEE IS RECOMMENDING.
>> THANK YOU.
AS SOMEONE WHO HAS DONE -- WHO
HAS MY PREVIOUS 30 YEARS OF
RESEARCH AS AN ACADEMIC IN
GLOBAL HEALTH RESEARCH, I AM
SYMPATHETIC TO WHAT YOU MIGHT BE
ASKING.
I KNOW THAT THERE IS AN EFFORT
TO FUND GLOBAL HEALTH RESEARCH,
BUT IT IS HALTED.
AND THERE IS A LOT OF DISCUSSION
AS FAR AS I HAVE HEARD ABOUT HOW
THE FOREIGN SUBCONTRACTS MAY BE
FUNDED OR INTEGRATED INTO THE
NIH SYSTEM.
BUT, AGAIN, YOU KNOW, IN MANY
WAYS YOU KNOW WHAT WE KNOW.
AND THERE HAS BEEN A STATEMENT
THAT THERE IS -- THAT THERE IS
VALUE IN GLOBAL HEALTH RESEARCH.
BUT THAT'S ABOUT THE EXTENT OF
WHAT I HAVE HEARD.
AND, AGAIN, JUST SPEAKING TO
ANNE'S COMMENT, WE DO HAVE AN
OPPORTUNITY INTERNALLY TO HAVE
THESE DISCUSSIONS AND VOICE WHAT
WE THINK IS IMPORTANT.
>> ANY OTHER COMMENTS OR WEST
FROM THOSE ATTENDING VIRTUALLY?
OR BACK IN THE ROOM, DR.
GLENSHAW?
>> NOT IN THE ROOM.
>> ALL RIGHT.
THANK YOU, DR. DONENBERG, IT'S A
CHALLENGING TIME DETERMINING THE
WAY FORWARD AND BEST WAY TO
CONSTRUCTIVELY SORT OF ADVANCE
THE FIELD IN MANY WAYS.
SO THANK YOU FOR YOUR CANDOR AND
FOR PRESENTING ALL THE
INFORMATION THAT'S AVAILABLE AND
WHAT WE CAN AND CANNOT
POTENTIALLY CONTRIBUTE TO AT
THIS TIME.
SO, WE'LL PROCEED WITH OUR
AGENDA.
AND NOW OUR NEXT PRESENTER DR.
SHAWN MULVANEY, HEALTH SCIENCE
ADMINISTRATOR, DIVISION OF
HEALTH INFORMATICS TECHNOLOGIES
AT NATIONAL INSTITUTES OF
BIOMEDICAL IMAGING AND
BIOENGINEERING, PRESENTING ON
THE ADVANCED PLATFORMS FOR HIV
VIRAL LOAD MONITORING AT POINT
OF CARE, AN AREA THAT IS OF HIGH
INTEREST ACROSS ALL CLINICAL
SETTINGS, AND ONE WE'VE BEEN
LOOKING FORWARD TO BRINGING
FORT.
I'M PLEASED TO WELCOME DR.
MULVANEY TO GIVE AN UPDATE AND
THE WAY FORWARD.
DR. MULVANEY?
>> GOOD AFTERNOON.
THANK YOU VERY MUCH FOR THAT
KIND INTRODUCTION.
I'M GOING TO CALL UP SOME SLIDES
FOR US TO SEE.
CAN YOU KINDLY SAY WHETHER YOU
CAN --
>> WE CAN SEE IT WELL.
IT SHOWS UP WELL.
>> PERFECT.
GOOD AFTERNOON.
AND THANK YOU, AGAIN, FOR THE
OPPORTUNITY TO BE HERE TODAY.
THANK YOU TO OAR.
I'M SHAWN MULVANEY, PROGRAM
OFFICER, NATIONAL INSTITUTE OF
BIOMEDICAL IMAGING.
FOR THOSE LESS FAMILIAR WITH
NIBIB WE'RE ONE OF THE SMALLER
I.C.s AT NIH.
WE DO NOT PARTICULARLY FOCUS ON
ANY DISEASE, CONDITION, OR BODY
PART.
BUT INSTEAD WE CONSIDER
OURSELVES TOOL BUILDERS.
OUR GOAL IS TO REALIZE THOSE
TOOLS, THAT MAKES POSSIBLE
SPECIFIC RESEARCH AND HEALTH
INTERVENTIONS NEEDED AND THEREBY
SHAPE THE FUTURE OF HEALTH.
TODAY I'D LIKE TO TAKE TIME TO
TALK ABOUT HIV VIRAL LOAD
MONITORING, AND OUR COLLECTIVE
DESIRE TO BRING FORTH PROJECTS
FOR DOMESTIC POINT-OF-CARE
MARKET.
THIS WORK IS CO-SPONSORED BY
OAR, NIAID, AND NIBIB.
BUT BEFORE WE GET TO THE HEART
OF THAT STORY, PLEASE LET ME
BEGIN BY TELLING A LITTLE BIT
RADx, RAPID ACCELERATION OF
DIAGNOSTICS PROGRAMS AND WHY WE
HAVE SOMETHING TO CONTRIBUTE.
BEFORE I GET TO THAT, A
DISCLAIMER TO START.
THE OPINIONS EXPRESSED HERE ARE
MY OWN.
THEY DO NOT NECESSARILY REFLECT
OPINIONS OF THE U.S. GOVERNMENT,
DEPARTMENT OF HEALTH AND HUMAN
SERVICES, NATIONAL INSTITUTES OF
HEALTH, NIBIB, AND ANY MENTION
OF RESEARCH ENTITY, COMPANY,
PRODUCT, OR TRADE NAME DOES NOT
CONSTITUTE OFFICIAL ENDORSEMENT
OF NOR CAUTION AGAINST.
RADx, WHAT WAS RADx?
IT WAS FORGED IN THE FIRES OF
THE COVID-19 PANDEMIC.
BY THE SPRING OF 2020, IF YOU
CAN TURN YOUR MIND BACK TO THEN,
OUR CHILDREN WERE DOING SCHOOL
IN THE LIVING ROOM, FOR MANY OF
US, ME INCLUDED, THE KITCHEN
TABLE WAS THE NEW OFFICE.
THE MOST CRITICAL PIECE OF
INTELLIGENCE IS WHICH STORE HAD
TOILET PAPER IN STOCK.
THOSE DAYS WERE SCARY.
EVERY AMERICAN NEEDED ACCESS TO
ACCURATE TESTING, THAT TESTING
DID NOT YET EXIST.
RADx FELT THIS TIME PRESSURE
ACUTELY.
WE VERY WELL UNDERSTOOD THAT
UNDER TYPICAL CIRCUMSTANCES
DIAGNOSTIC TESTS REQUIRE 3 TO 5
YEARS OF R&D, PLUS REGULATORY
STUDIES TO REACH MARKET.
WE WERE BEING ASKED TO ACHIEVE
THIS FEAT IN A MATTER OF MONTHS.
QUITE FRANKLY FAILURE WAS NOT AN
OPTION.
AS WE AT THIS SLIDE ON THE LEFT
WE CAN SEE THE FUNNEL STRUCTURE
THAT HAS BECOME SYNONYMOUS WITH
THE RADx BRAND.
THE FUNNEL DESIGN INTEGRATED
BEST PRACTICES FROM INDUSTRY,
ACADEMIA, GOVERNMENT, WITH THE
GOAL OF DE-RISKING EACH AND
EVERY PROJECT AS SOON AS
POSSIBLE AND ALONG THE WAY.
FOLLOWING CALL FOR PROPOSAL,
FIRST CUT MADE BASED ON
APPLICATIONS.
ADVANCING IDEAS WERE PAIRED WITH
TEAMS WHO USED INTERVIEWS TO VET
THE TECHNOLOGY ITSELF BUT ALSO
ORGANIZATION, THEIR
INFRASTRUCTURE, AND THOSE
CRITICAL ELEMENTS REQUIRED FOR
THIS PROJECT TO BE A SUCCESS.
THIS IS WHERE RADx WAS
COMPARED TO THE TV SHOW, THE
SHARK TANK.
YOU CAN SEE OUR SHARK LOGO
THERE.
OUR HOLICKIST APPROACH, MANY
WORK STREAMS HAD TO WORK IN
PARALLEL, RADx NEEDED TO
QUICKLY DETERMINE WHAT WERE THE
LIKELY BARRIERS TO SUCCESS,
CRITICALLY IF THOSE BARRIERS
COULD BE OVERCOME.
AS THE PROJECT MOVED FORWARD.
ON THE RIGHT-HAND SIDE OF THE
SLIDE YOU CAN SEE OUTCOME
MEASURES WHICH GREATLY EXCEED
OUR OWN EXPECTATIONS.
WE BROUGHT OVER 8 BILLION
POINT-OF-CARE AND OVER THE
COUNTER TESTS TO THE PUBLIC,
SHIFTING THE TESTING PARADIGM
AWAY FROM CENTRAL LABS.
IT'S WORTH REFLECTING WHILE WE
HAD FAITH IN THE FUNNEL
APPROACH, SUCCESS WAS NOT
PRE-DETERMINED.
DRAMATICALLY REDUCING TIME TO
MARKET FOR THESE TECHNOLOGIES
HAD NEVER BEEN ACHIEVED.
NOW ONE OF THE ADVANTAGES WE HAD
AND WHY NIBIB WAS POISED TO
ATTEMPT SUCH A FEAT WAS
EXISTENCE AND GROWTH OF THE
POINT-OF-CARE TECHNOLOGY
RESEARCH NETWORK, POCTRN.
POCTRN WAS A U54 PROGRAM LUNCHED
IN 2007, AND THEY HAVE SINCE
GAINED OVER A DECADE OF
EXPERIENCE IN THE TRANSLATION
AND DIAGNOSTIC DEVICES.
WITH MULTIPLE CENTERS COVERING
COMPLEMENTARY FOCUS AREAS,
POCTRN HAS BUILT KEY
CAPABILITIES AND EXPERTISE THAT
WOULD PROVE INVALUABLE TO A
RAPID RESPONSE EFFORT.
UNDER THE GUIDANCE OF THE POCTRN
COORDINATING CENTER THE, THE
WISDOM OF COLLEAGUES HELPED
SHAPE THE DESIGN OF THE
INNOVATION FUNNEL MODEL, WITH
KEEN EYE TO MAXIMIZING
ACCELERATION.
GIVEN THE CONSTRAINTS WE WERE
UNDER, PARDON ME, GIVEN
CONSTRAINTS THE CREATION OF THE
RADx PROCESS WAS NOT INVENTION
OF SOMETHING COMPLETELY NEW OR
UNIQUE.
RATHER, IT WAS LARGELY AN EFFORT
TO INTEGRATE BEST PRACTICES
WHILE LEVERAGING AVAILABLE
RESOURCES AND OF COURSE THE
PROFESSIONAL NETWORKS INHERENT
THEREIN.
POCTRN ALLOWED US TO EXERCISE
STRENGTH WE HAD BEEN BUILDING
AND TO PIVOT AND AMPLIFY IN A
TIME OF URGENCY AND GREAT
NATIONAL NEED.
AS WE'VE HAD THE OPPORTUNITY TO
ANALYZE THE OUTCOMES, AND
REFLECT ON THE STRUCTURES AND
WORKFLOWS IMPLEMENTED, WE'VE
COME TO BETTER UNDERSTAND THE
KEY FEATURES OF THE RADx
MODEL, THAT CONTRIBUTE TO
ACCELERATED PACE AND ACHIEVEMENT
OF PROJECTS.
HERE WE LIST A NUMBER OF PROGRAM
FEATURES WE THINK ARE CRITICAL.
THE IDEA MAY SEEM FAMILIAR, AND
ARE PARTS OF OUR TRANSLATIONAL
PROGRAMS, BUT THEIR
IMPLEMENTATION AS RADx IS HOW
WE CUSTOMIZED SUPPORT AND
ACCELERATED MULTIPLE PARALLEL
PATHWAYS TO REACH A COMMON
ENDPOINT.
DUE TO THE TIME LIMITS TODAY I'M
NOT GOING TO DELVE DEEPLY INTO
EACH BUT LET ME BRIEFLY TOUCH ON
SOME OF THEM.
EACH INNOVATOR WAS PAIRED WITH A
RADx TEAM THAT CONSISTED OF
PORTFOLIO EXECUTIVE, TEAM LEAD,
PROJECT FACILITATOR.
THE PORTFOLIO EXECUTIVE AND TEAM
LEAD HAVE DECADES OF INDUSTRIAL
EXPERIENCE BRINGING DIAGNOSTIC
PRODUCTS TO MARKET.
THEIR EXPERIENCE AND CLOSE
WORKING RELATIONSHIP FUELED
INTENSIVE RISK ASSESSMENT
THROUGHOUT THE PROCESS.
CONCURRENTLY OFFERING THESE
ENTREPRENEURIAL TEAMS MENTORSHIP
AND ADVICE THAT THEY MAY NOT
HAVE HAD ACCESS TO.
RADx THEN ESTABLISHED A
LIBRARY OF SUBJECT MATTER
EXPERTS FROM ASSAY DESIGN TO
SUPPLY CHAIN MANAGEMENT TO
COMMERCIALIZATION TO REGULATORY
AFFAIRS AND MUCH, MUCH MORE.
THESE EXPERTS COULD BE TAPPED AS
NEEDED, USE TO DE-RISK PROJECTS,
INDEPENDENT ASSESSMENT OF
TECHNOLOGY READINESS INNOVATORS
HAD CRITICAL FEELBACK AND
UTILIZED MILESTONE CONTRACTS TO
DEFINE, ESTABLISH INSTEAD, YES,
AGGRESSIVE SCHEDULE, BUT
PROVIDED ALL PARTIES CLEAR
CRITERIA FOR SUCCESS AT EACH
STEP.
AND WHERE WE'RE WERE GOING FROM
THERE.
CONTRACTING MAY BE THE ITEM ON
THE LIST YOU MAY FIND MOST
SURPRISING BUT WE CAN ASSURE YOU
IT'S CRITICAL FACTORS TO OUR
SUCCESS.
RADx DESIGNED FLEXIBLE
MECHANISMS APPLIED ACROSS
TECHNOLOGIES, LIKE RESPONDING TO
VIRAL PANDEMIC.
I'D LIKE TO PAUSE AND
ACKNOWLEDGE THE UNWAVERING
SUPPORT FROM OUR COLLEAGUES AT
THE NHLBI OFFICE OF ACQUISITION
WHO HAVE BRILLIANTLY AND
TIRELESSLY WORKED TO ESTABLISH
CORE STRUCTURES.
I WOULD LIKE TO ACKNOWLEDGE ALL
OF THE PEOPLE WHO CONTRIBUTED TO
RADx, FAR TOO MANY TO LIST BY
NAME.
I WON'T TRY TO DO THAT HERE.
I MAY BE THE FIRST TELLING YOU
THE STORY BUT KNOW I PLAYED A
SMALL PART.
THIS IS A STORY OF HUNDREDS
ROLLING UP SLEEVES AND A BIG
THANK YOU IS OWED TO ALL OF
THEM.
SO THANK YOU.
BACK TO THE STORY.
ALONG WITH THE ACCELERATING
ATTRIBUTES AND CAPABILITIES OF
POCTRN CENTER'S NETWORK THE
PRIMARY CHALLENGE WAS TO CODIFY
ORGANIZATIONAL AND FUNDING
STRUCTURES TO SUSTAIN OUR
ONGOING EFFORTS.
DEPICTED ON THE RIGHT-HAND SIDE
OF THE SLIDE YOU CAN SEE THREE
FOUNDATIONAL CONTRACT VEHICLES,
WHILE CREATING SCALABILITY AND
HEAD ROOM FOR FUTURE ACTIVITIES
INCLUDING HIV PROGRAM WE'LL TALK
ABOUT TODAY.
THREE PRIMARY CONTRACTS ARE
FIRST COORDINATION CENTER
MANAGED BY CIMIT.
THEIR RESPONSIBILITIES INCLUDE
ESTABLISHMENT OF STANDARD
OPERATING PROCEDURES AND
WORKLOAD, PROPOSAL INTAKE AND
PROCESSING, PROJECT RISK
ASSESSMENT, MANAGEMENT AND
ENTREPRENEURIAL TRAINING OF THE
TEAM.
SECOND, COMMERCIALIZATION
CENTER, THIS WAS LED BY
VENTUREWELL.
THEY OVERSAW THE CURATION OF
NETWORK OF PROFESSIONAL EXPERTS
AND DEPLOYMENT OF THOSE HUMAN
RESOURCES ACROSS THE VARIOUS
PROMISE.
THIRD, VALIDATION CENTER WHICH
WAS ANCHORED AT EMORY
UNIVERSITY.
THEY PERFORMED TESTING AND
EVALUATION SERVICES OF THE
VARIOUS TECHNOLOGIES AND
DEVICES.
AS I LIKE TO SAY, THEY JUST
TESTED THE TEST AND GAVE US THE
FACTS.
TOGETHER THESE THREE CENTERS
UNDER THE CONTRACTING STRUCTURES
SEEN HERE FORM A STABLE PLATFORM
THAT CAN PROVIDE TECHNOLOGY
ACCELERATION ACROSS THE
HEALTHCARE SPECTRUM.
WITH THAT VERY ABBREVIATION THE
INTRODUCTION LET ME TURN TO THE
GROWING HEALTH INITIATIVES TO
UTILIZE RESOURCES.
THERE'S A WIDE ARRAY OF
DECISIONS, TESTING, MATERNAL
HEALTH, FETAL HEALTH, AND MORE.
EACH OF THESE PROGRAMS CAN BE
TAILORED TO REACH THE
OPPORTUNITY AND SPONSOR FUNDS
THAT ARE AVAILABLE TO RUN THE
PROGRAM.
AGAIN, WE DON'T HAVE TIME TO
TALK ABOUT THOSE ITEMS TODAY BUT
I'M HAPPY TO HAVE THOSE
DISCUSSIONS LATER.
ONE OF OUR STRONGER PARTNERS HAS
BEEN OFFICE OF AIDS RESEARCH.
LET'S FINISH WITH A DISCUSSION
OF ONGOING VIRAL LOAD PROGRAM.
IN CLOSE COLLABORATION WITH OAR
AND NIBIB, NIBIB IS ENGAGED IN
ADVANCE PLATFORMS FOR HIV VIRAL
LOAD AT POINT OF CARE.
THIS 15-MONTH PROGRAM SEEKS TO
ACCELERATE TECHNOLOGY TO DESIGN,
HAVING DE-RISKED MAJOR AREAS OF
EACH PROJECT, AND REACHING POINT
WHERE CLINICAL TRIALS IS THE
LOGICAL NEXT STEP.
WE'LL TALK A BIT MORE ABOUT THE
TECHNICAL PRODUCTS PROFILE, TPP,
IN THE COMING SLIDES BUT FIRST
LET'S VISIT THE OTHER AREAS OF
SUPPORT RADx IS OFFERING,
LEVERAGING STRENGTH OF POCTRN
CENTERS TO OFFER THIRD PARTY
TESTING FOR USABILITY,
ANALYTICAL CAPABILITIES, EVEN A
PRE-CLINICAL EVALUATION WITH
REAL WORLD SAMPLES.
WRAP-AROUND SUPPORT WILL INCLUDE
INFORMATION ABOUT BLOOD
COLLECTION DEVICES, A
MARKETPLACE LANDSCAPE ANALYSIS.
SO USING THE RADx MODEL THAT I
DESCRIBED A FEW SLIDES AGO, WE
PUT OUT A CALL AND CIMIT
RECEIVED 27 APPLICATIONS.
19 MET MINIMUM REQUIREMENTS.
EXPERT PAN PARED DOWN FOR A DEEP
DIVE AND VETTING.
THE TEAMS HAVE INTERACTIONS WITH
INNOVATORS OVER SEVERAL WEEKS
EVALUATING STRENGTH, WEAKNESSES,
MOST IMPORTANTLY THE RISKS
AHEAD.
RADx INNOVATOR TEAMS PUT
TOGETHER A PITCH DECK THAT LAID
OUT TECHNICAL INFORMATION, WHAT
THEY FORESAW AS THE SCHEDULE AND
MILESTONES REQUIRED TO BE
SUCCESSFUL IN THE VIRAL LOAD
PROGRAM.
THOSE PRESENTATIONS WERE
EVALUATED BY RADx FUNDING
PANELS AND THREE TEAMS WERE
SELECTED TO ADVANCE.
BEFORE WE LOOK AT THOSE THREE
TEAMS AND TECHNOLOGIES, LET'S
DISCUSS HOW WE GOT HERE ON THE
OTHER SIDE OF THE PROGRAM, THE
HIV SIDE OF THE PROGRAM.
FOR THE PAST 3 YEARS I'VE BEEN
PART OF OAR'S HIV DIAGNOSTICS
WORKING GROUP.
THIS DYNAMIC GROUP HAS DONE MUCH
WORK BUT IN 2023 THE WORKING
GROUP CONTRIBUTED TO THE
COMMUNITY VOICES MEETING.
AT THAT MEETING COMMUNITIES
SHARED PREFERENCES FOR TESTING
AND CARE.
WE HEARD FROM PRACTITIONERS
ABOUT USE AND VARIOUS SETTINGS,
AND THE EXPERTS FROM THE POCTRN
COMMUNITY DESCRIBED WHAT
TECHNOLOGIES WERE AVAILABLE OR
WERE UNDER DEVELOPMENT IN THE
HIV SPACE.
DURING THIS TIME FRAME OAR ALSO
CEDED THE VIRAL LOAD DEVELOPMENT
COMMUNITY WITH -- SEEDED WITH
FUNDS TO NORTHWESTERN AND JOHNS
HOPKINS POCTRN CENTERS IN A
PROGRAM WE CALLED HIV VIRAL LOAD
MINI FUNNEL.
THIS PROGRAM USED RADx
INFRASTRUCTURE BUT AT A MODEST
INVESTMENT LEVEL, WE FUNDED SIX
TEAMS WITH NOT A MARKET READY
PROJECT, A BRIDGE TOO FAR, BUT
INSTEAD TO ACT AS ACCELERATING
FORCE THAT MOVED NASCENT AND
PROTOTYPES, THE POSSIBILITY WAS
THERE BUT WE HAD TO MOVE THE
TECHNOLOGY ALONG OF THE
CONTRIBUTING TO DUE DILIGENCE,
POCTRN CENTERS AT NORTHWESTERN
AND JOHNS HOPKINS REMAINED
ACTIVE IN THE HIV SPACE AND
THEIR KNOWLEDGE BASE CONTINUES
TO INFORM US ABOUT VIRAL LOAD
TESTING FOR BOTH DOMESTIC AND
GLOBAL MARKETS.
ON THE RIGHT-HAND SIDE OF THE
SLIDE YOU SEE A FIGURE FROM A
PENDING MANU SCRIPT AUTHORED BY
CLINICIANS AT JOHNS HOPKINS,
NORTHWESTERN, UNIVERSITY OF
WASHINGTON.
WHAT IS EMPHASIZED HERE IS THAT
THERE ARE NO FDA-APPROVED VIRAL
LOAD TESTS FOR THE POINT-OF-CARE
MARKET AVAILABLE TODAY.
THERE ARE A HANDFUL IN THE
GLOBAL MARKET BUT DOMESTIC
MARKET DOES NOT YET EXIST.
ALSO IN THAT PENDING MANUSCRIPT
THE AUTHORS DRILL DOWN ON USE
CASE SCENARIOS AND DISCUSS IN
DETAIL WHAT TESTING ATTRIBUTES
MAY BE MOST CRITICAL AND
DESIRABLE.
AS YOU CAN SEE HERE IN THEIR
ANALYSIS, THE WHY OR WHEN YOU'RE
TESTING MAY CHANGE HOW ONE
CHOOSES TO TEST, AND WITH WHAT
TYPE OF TEST.
AMONGST AUTHORS ARE FACULTY AT
NORTHWESTERN, KELLOGG SCHOOL OF
MANAGEMENT.
THEY ARE INGAUGED IN
UNDERSTANDING THE MARKET FOR FOR
HIV TESTING HELPING US ROUND OUT
DUE DILIGENCE.
THAT KELLOGG TEAM HAS EXPLORED
THE GLOBAL MARKETS WITH A
CONJOINED ANALYSIS THAT WEIGHS
COMBINATIONS OF TEST
CHARACTERISTICS TO TEASE OUT THE
MOST INFLUENTIAL CHARACTERISTICS
FOR HIV VIRAL LOAD TEST
SELECTION.
FOR THIS ANALYSIS THEY USE 14
LEVELS.
I LOVE TO PORE THROUGH THE DATA,
SO INTERESTING, EVEN BETTER YET
HAVE TARA PREVENT -- PRESENT BT
LET'S LOOK AT THE BIG PICTURE.
SENSITIVITY IS THE ATTRIBUTE,
WITH PRICE AND TIME HAVING
SIGNIFICANCE.
THE KELLOGG TEAM IS AGAIN
PARTNERING WITH JOHNS HOPKINS TO
MAKE THIS INFORMATION KNOWN IN A
MANUSCRIPT IN PREPARATION,
SHOULD BE ABLE SOON.
WITHIN THE RADx VIRAL LOAD
PROGRAM THAT TEAM IS NOW WORKING
ON A CONJOINED ANALYSIS FOR THE
U.S. DOMESTIC MARKET AND WE
EAGERLY AWAIT THOSE RESULTS.
LET'S MOVE ON TO THE TARGET
PRODUCT PROFILE OF THE TPP.
INTO THIS LANDSCAPE OAR, NIAID,
AND NIBIB OPENED THE FULL VIRAL
LOAD MONITORING FUNNEL.
THE GOAL IS ACCELERATING
TECHNOLOGY FOR THE POINT-OF-CARE
DOMESTIC MARKET.
WE HAD TO DEFINE TPP, STARTED
WITH WHAT WAS AVAILABLE, ON
VIRAL LOAD MORE THANKING TOKER.
WE LAYERED IN DESIRE TO MOVE
TESTING CLOSER TO PARTICIPANTS
AS ASKED, IN THE COMMUNITY
VOICES MEETING.
WE WANTED THOSE TESTS TO BE
SUITABLE FOR POINT OF CARE
MARKET, IDEALLY THE CLIA
SETTING.
THIS MEANT WHOLE BLOOD, MINIMUM
SAMPLE HANDING, TOTAL TIME UNDER
AN HOUR.
WE LIKE THE ANSWER IN 30
MINUTES, FOR QUANTITATIVE AND
VERY SENSITIVE AND WE'RE
SPEAKING LOWER LIMITS OF
QUANTITATION OF 200 COPIES.
THIS IS A SIGNIFICANT ASK OF
THESE COMPANIES.
WE ABSOLUTELY UNDERSTAND THAT.
BUT VARIOUS ASPECTS OF THE
TECHNOLOGICAL CHALLENGE HAVE
BEEN SOLVED FOR OTHER TARGETS
AND OTHER COMPLEX MATRICES IN
THE GREATER TECHNOLOGY
LANDSCAPE.
THE QUESTION IS, WHAT CAN WE GET
DONE HERE AND FOR HIV VIRAL LOAD
MONITORING.
ONE OF THE COMMON CHALLENGES IS
ALWAYS GOING TO BE THE SAMPLE
AND ITS VOLUME.
WE'RE ASKING THESE TEAMS TO
START WITH WHOLE BLOOD.
THEY CAN PROCESS THAT SAMPLE ON
OR OFF THE DEVICE BUT NEED TO
FIGURE OUT HOW MUCH SAMPLE IS
NEEDED, HOW THEY ARE GOING TO
GET TO QUANTITATIVE ASSAY, 200
COPIES PER ML, NEED TO
BACK-CALCULATE HOW MUCH BLOOD TO
START WITH TO DO THOSE THINGS.
SUGGESTING HIGHER VOLUME THAN
FINGER STICK VOLUME MAY BE
NEEDED.
WE ASKED EMORY TO LOOK AT BLOOD
COLLECTION DEVICES, EACH HERE
HAS SOME FORM OF REGULATORY
APPROVAL.
BUT WHAT WE WANTED TO KNOW WAS
HOW WELL DID THEY WORK, WHAT
VOLUME DID THEY DRAW, HOW FAST
DID IT DRAW THAT VOLUME, HOW
RELIABLY DOES THAT HAPPEN,
PARTICIPANT TO PARTICIPANT, DOES
IT HURT OR LEAVE A SCAR?
ON A SECOND SHELF THAT A QUALITY
SAMPLE, SUITABLE FOR VIRAL LOAD
TESTING?
EMORY IS STARTING WITH THE
DEVICE HERE.
BUT EACH OF THE TEAMS THAT WE'LL
TALK ABOUT ARE DOING THEIR OWN
RESEARCH AS WELL.
BROADLY I WILL ALSO NOTE THAT A
MOVE TO DECENTRALIZE MEDICINE
THAT WE SAW THROUGHOUT THE LAST
FIVE YEARS IS QUICKENING, SUCH A
STUDY IS NOT ONLY GERMANE TO HIV
BUT TO ALL BLOOD-BASED
DIAGNOSTICS, A COMMON THEME YOU
CAN SEE IN THE GATES GLOBAL
CHALLENGE I HIGHLIGHTED AT THE
LOWER RIGHT OF THE GRAPH.
THEY WANT TO ENHANCE HIV AND
TUBERCULOSIS DIAGNOSTICS, AND TO
THAT THEY GOT A ROBUST RESPONSE.
I EXCITEDLY AWAIT TO SEE WHAT
THEY DEVELOP IF IT'S APPLICABLE
TO OUR PROGRAM AND PROGRAMS IN
THE FUTURE.
LET'S TAKE A CLOSER LOOK AT THE
THREE TEAMS WE'RE FUNDING.
THESE THREE TEAMS PRESENT WITH
UNIQUE QUALITIES AND CHALLENGES
ACROSS THEIR APPROACHES.
CEPHEID WILL BE MODIFYING WHICH
RUNS ON GENE EXPRESS PLATFORM.
BAEBIES AIMS TO ADD TO THE
FINDER PLATFORM, FDA APPROVED
FOR INFANT ANEMIA.
PROMPT IS DEVELOPING MAG NEED OH
FLUIDIC INSTRUMENT FOR THIS
CHALLENGE.
NOTE THAT BAEBIES AND PROMPT ARE
ALUMNI OF THE VIRAL LOAD MINI
FUNNEL WHICH I HOPE THEY WOULD
AGREE HELPED PREPARE THEM TO
SUCCESSFULLY COMPLETE WITHIN
THIS LARGER FUNNEL HERE.
FIRST TEAM, CEPHEID IS
DEVELOPING THEIR VIRAL LOAD TEST
FOR THE PLATFORM, 60,000 EXPERTS
IN THE FIELD GLOBALLY, HAVE 35
TESTS AVAILABLE FOR THE
PLATFORM.
THIS INCLUDES HEPATITIS C TEST
FOR USE AT THE POINT OF CARE
ALSO DEVELOPED IN COLLABORATION
WITH RADx.
AS I MENTIONED EARLIER, CEPHEID
DOES HAVE AN HIV VIRAL LOAD TEST
AVAILABLE ON THE GLOBAL MARKET.
IT'S CAPABLE OF 40 COPIES, LOWER
LIMIT OF QUANTITATION, RUN WITH
ONE MIL, USING CAPILLARY BLOOD,
FILTERED IN THE CARTRIDGE
ITSELF.
REQUIRING NO TEST BY USER.
DUE TO LIMITATIONS OF HOW MUCH
BLOOD AND THEREFORE PLASMA, ONE
CAN COLLECT IN CAPILLARIES, THEY
ARE EXPECTING HIGHER LIMIT THAN
40 COPIES.
NATIONALLY WORKING TO A GOAL OF
200 COPIES PER ML.
LESSONS LEARNED FROM THE HEP C
TEST ARE LEVERAGED HERE FOR THE
HIV VIRAL LOAD ASSAY.
THE TEAM WILL BALANCE
COLLECTION, FILTRATION, TARGET
AVAILABILITY TO REACH FINAL
PERFORMANCE METRIC.
THE UNIQUE ABILITY OF THE EXPERT
SYSTEM TO HANDLE SUCH FLUIDIC
CHALLENGES PROVIDES PATHWAYS FOR
MEANINGFUL RESULTS.
HOW THE INITIAL SAMPLE IS
COLLECTED AND WHAT VOLUME IS
ROUTINELY COLLECTED ARE CLEARLY
CRITICAL FACTORS AS THEY MOVE
FORWARD.
INITIAL FEASIBILITY STUDIES SEEN
IN THE UPPER RIGHT-HAND SIDE OF
THIS SLIDE WITH DETECTION DOWN
TO 200 COPIES PER ML,
DEMONSTRATED IN BENCH TOP ASSAYS
WITH REDUCED INPUT VOLUMES.
CEPHEID TEAM WORKS ON
FILTRATION, FLUIDIC HANDLING,
CARTRIDGE CHANGES.
YET AGGRESSIVE TIMELINES WILL
PUSH THEM TO HAVE THIS DONE THIS
FALL FOR END TO END CUSTOMER
TESTING.
SECOND TEAM IS BAEBIES, A
DIGITAL FLUIDIC SYSTEM WITH PCR
READOUT, SYSTEM HAS CAPABILITY
FOR GENOMIC, A SINGLE SYSTEM
WITH A MENU OF TESTS.
AT PRESENT BAEBIES HAS FDA
APPROVED TEST FOR ANEMIA.
G 6 HELPS PROTECT RED BLOOD
CELLS FROM DAMAGE, CAUSING
HEMOLYTIC ANEMIA.
FOR THIS PROGRAM BAEBIES
ENVISIONS HIV AMONG MOLECULAR
TEST MENU.
FINDER PLATFORM AND CARTRIDGE IS
BASED ON DIGITAL FLUIDICS, SOME
MAY NOT BE FAMILIAR WITH.
DIGITAL FLUIDICS IS CONTROL OF
LIQUID SAMPLE AMONGST A SET OF
ELECTRONIC PATHS.
LET ME START A VIDEO FOR
EVERYONE TO SEE HERE.
THIS VIDEO WILL GIVE YOU A SENSE
OF FIDELITY IN WHICH LIQUID CAN
BE HANDLED ON SUCH CARTRIDGE,
HEATING ELEMENTS LOCATED AT
KNOWN LOCATIONS AROUND THE
CARTRIDGE, TOGETHER THEY MAKES
FOR A POWERFUL PLATFORM FOR
SUITABLE FOR MANY ASSAYS.
LIKE THE OTHER TWO TEAMS,
BAEBIES IS WORKING AGAINST A
SIGNIFICANT CHALLENGE RADx
POSTS.
THEY ARE TRYING TO UNDERSTAND
HOW SAMPLE COLLECTIONS, SAMPLE
VOLUME, AND WORKFLOW WILL PLAY
IN THE FINAL PRODUCT DESIGN.
NOTABLY THE TOTAL VOLUME USED
PRESENTS TRADEOFFS WITH FLUID
HANDLING.
THESE STEPS ARE A DANCE,
COMPLEXITY GOES UP WITH THE
GREATER VOLUME.
SO WE NEED TO FIGURE OUT HOW TO
PROCESS TOTAL VOLUME REQUIRED TO
REACH THE SENSITIVITY REQUIRED.
ON THE LEFT-HAND SIDE OF THIS
SLIDE WE CAN SEE PRELIMINARY
DATA FOR WET REAGENT VERSIONS OF
THE ASSAY, DEMONSTRATING
DETECTION AS LOW AS 200 COPIES
PER ML LEAVING ROOM FOR FURTHER
DEVELOPMENT AND TRADEOFFS ON THE
CARTRIDGE.
IN THE DATA SHOWN ON THE RIGHT
OF THE SLIDE ASSAY HAS
APPLICABILITY ACROSS MANY HIV
CLADES.
THIS MARKS A PROMISING START TO
THE TEAM.
OUR THIRD COMPANY IS PROMPT
DIAGNOSTICS.
PROMPT IS A SMALL COMPANY THAT
FORMED OUT OF JOHNS HOPKINS,
HAVE AT CORE MAGNITO CORE
FLUIDIC EXPERTISE.
IN THE HIV SPACE, PROMPT WAS ONE
OF OUR PARTICIPANTS IN THE MINI
FUNNEL.
ON THE RIGHT-HAND SIDE OF THE
SLIDE YOU CAN SEE EMBODIMENT OF
VIRAL LOAD ASSAY, IN EARLY
CONCEPT FOR SAMPLE HANDLING.
WORKING PROTOTYPE OF THE PCR
INSTRUMENT ON THE FAR RIGHT.
THE COMPACT PORTABLE INSTRUMENT
AND DISPOSABLE CARTRIDGE
DEVELOPED IN THE MINI FUNNEL
SERVE AS STRONG BASE FROM WHICH
THE CURRENT PROJECT CAN BUILD
AND MEET THE TPP SPECIFICATIONS
REQUIRED.
AT THE HEART OF THE PLATFORM
REMAINS MAGNETO SAMPLE
MANIPULATION THAT BINDS VIRAL
MATERIAL AND MOVES IT THROUGH
PURIFICATION, LOCATION,
DETECTION.
LIKE THE OTHER TWO TEAMS, PROMPT
IS ADAPTING ASSAY AND PROTOCOLS
TO DEAL WITH REALITY OF WHAT
VOLUME OF WHOLE BLOOD THEY WILL
UTILIZE AND TRADEOFFS FOR
SENSITIVITY, TIME, INSTRUMENT
AND CARTRIDGE DESIGN.
ON THE RIGHT-HAND SIDE YOU CAN
SEE PRELIMINARY DATA FOR THE
DETECTION OF 200 COPIES PER ML
IF ALL OF THOSE TRADEOFFS YIELD
100 MICROLITER PLASMA SAMPLES TO
BEGIN.
AS PROMPT WORKS TO HARDEN
PERFORMANCE THEY ARE LOOKING AT
HOW THE TPP SPECIFICATIONS PLAY
INTO TOTAL WORKFLOW.
EVE ENGAGED DESIGN PARTNERS,
ENVISIONING A NEW CONFIGURATION
FOR POINT OF CARE AND CLIA
SETTINGS.
WITH THAT INTRODUCTION TO THE
HIV TEAM, LET ME LEAVE YOU WITH
FINAL THOUGHTS.
STARTING WITH THE RADx VALUE.
WE FEEL THROUGH THE CRUCIBLE OF
THE PANDEMIC, RADx WAS
PRESSURE TESTED.
WE HAVE A GREAT TEAM OF PEOPLE
WITH TIMELINES AND SUCCESS.
SOME MECHANICS -- MEMBERS HAVE
TESTS IN THEIR MEDICINE CABINET
AS WE SPEAK.
WE'VE COME TO UNDERSTAND AND
BELIEVE THAT IN-KIND SERVICES
CAN GENERATE MORE VALUE TO
PROJECTS THAN FUNDING SUPPORT
ALONE.
THE EXPERT GUIDANCE AND
MENTORSHIP CAN HELP TEAMS AVOID
COSTLY MISTAKES AND VALIDATION
SUPPORT CAN PROVIDE A RESOURCE
THAT DE-RISK DECISION MAKING,
ADDS CREDIBILITY IN THE INVOLVED
AND VC COMMUNITY AT LARGE.
CUSTOMIZABLE NATURE AFFORDS
GREAT FLEXIBILITY AS
DEMONSTRATED ACROSS CLINICAL AND
TECHNOLOGICAL AREAS IN PROCESS.
PARTNERSHIPS INSIDE AND OUTSIDE
GOVERNMENT HAVE BEEN KEY FOR
BUILDING A SUSTAINABLE
INFRASTRUCTURE FOR RADx AND
WILL CONTINUE TO ENABLE US TO
WITHSTAND THE SCOPE OF THE
IMPACT.
FOR ANYONE INTERESTED, TWO
COLLABORATORS PUT TOGETHER A
BOOK ON THE RIGHT-HAND SIDE OF
THE SLIDE.
OR YOU CAN REACH OUT TO NIBIB
DIRECTOR FOR MORE INFORMATION
ABOUT THE RADx PROGRAM.
FOR HIV VIRAL LOAD, WE HAVE
THREE PROMISING TEAMS WITH THREE
UNIQUE APPROACHES AND I'M BUOYED
BY THE EARLY RETURNS.
RADx ACCELERATORS ARE IN PLACE
TO SUSTAIN THIS MOMENT,
INCLUDING USABILITY, ANALYTICAL,
PRE-CLINICAL EVALUATION TO
ASSIST INNOVATORS AND SHOULD
INFORM IF CLINICAL TRIALS ARE
THE SUITABLE NEXT STEP.
WE HAVE HEARD THE COMMUNITY'S
CALL TO BRING TESTING CLOSER TO
THE PARTICIPANTS AND OUR FIRST
STEP IS TO FULFILL OPEN DOMESTIC
POINT-OF-CARE MARKET.
LET ME CLOSE BY THANKING MANY
PEOPLE IN RADx AND IN EACH OF
OUR HIV VIRAL LOAD PARTNER
COMPANIES FOR THEIR COMMITMENT
TO BETTER HEALTH OUTCOMES.
THESE ARE STILL VERY EARLY DAYS
FOR THE HIV VIRAL LOAD PROGRAM
AND I HOPE TO HAVE MUCH MORE TO
SHARE WITH YOU IN THE FUTURE.
LET ME THANK YOU FOR YOUR KIND
ATTENTION AND I'D BE HAPPY TO
TAKE ANY QUESTIONS AND OPEN THE
FLOOR FOR FURTHER DISCUSSION.
THANK YOU VERY MUCH.
>> THANK YOU.
EXCITING PROGRESS ON ALL THREE
FRONTS AND THE PROGRAM AS A
WHOLE.
WE'LL START WITH A DISCUSSION
AND, AGAIN, I'LL GO WITH THE DR.
GLENSHAW IN THE ROOM AND
VIRTUALLY.
I'LL START SINCE IT'S REALLY
EXCITING.
JUST TO COMMENT, THREE PLATFORMS
ARE ON PLASMA, CORRECT?
NOT WHOLE BLOOD, ON THE PLASMA
FRACTION, AND CAN YOU COMMENT ON
COST, WAS THAT ADDRESSED
RELATIVE TO DEVELOPMENT?
BECAUSE THE TECHNOLOGY WOULD BE
AS ACCESSIBLE AS IT IS
AFFORDABLE.
SO WHAT SORT OF PRIORITIES OR
GUIDELINES ARE IN PLACE TO
ADDRESS THAT COMPONENT?
>> THANK YOU FOR THE TWO
QUESTIONS.
THE FIRST IS WE TOLD THE TEAM
THEY NEEDED TO START WITH WHOLE
BLOOD AND GAVE THEM THE
CHALLENGE OF BEING SUITABLE FOR
CLIA WAIVED SETTINGS.
WHAT THEY DID WITH THAT SAMPLE
AFTER COLLECTION WAS THEIR
CHOICE.
SO, YES, ALL THREE TEAMS AT THE
MOMENT ARE SEPARATING OUT FOR
THE PLASMA FRACTION, AND THAT IS
GUIDING THEIR VOLUME CHOICES AT
THE MOMENT.
BUT WE DID NOT PRESCRIBE FOR
THEM THAT THEY HAD TO START WITH
PLASMA.
WE SAID YOU'RE STARTING AT THE
PATIENT, GIVE ME AN ANSWER.
THE SECOND PART OF YOUR QUESTION
WAS WE DID NOT PUT ANY
CONSTRAINTS OR EXPECTATIONS ON
PRICE AT THIS POINT.
WE'RE ATTEMPTING TO FULFILL A
COMPLETELY UNMET MARKET.
AND WE WANTED TO GET TECHNOLOGY
THAT WAS SUITABLE FOR THAT
MARKET READY AND TO A POINT
WHERE REGULATORY TESTING AND
POTENTIAL APPROVAL MADE LOGICAL
SENSE.
>> THANK YOU.
DR. GLENSHAW, ARE THERE ANY
COMMENTS OR QUESTIONS FROM THE
ROOM?
>> NO, NOT AT THIS TIME.
>> THANK YOU.
WE HAVE A COUPLE HANDS UP.
I'LL START WITH DR. NEILAN.
>> FASCINATING PRESENTATION HOW
FEDERAL SUPPORT REALLY
ACCELERATED THIS AREA OF
TREMENDOUSLY HIGH NEED, POINT OF
CARROLL VIRAL LOAD TESTING.
PATIENTS AND CLINICIANS,
RESEARCHERS WOULD LOVE TO HAVE
THIS.
ONE CAN SEE HOW THIS ALIGNS WITH
DR. DON ENBERG'S PRESENTATION,
THAT WOULD BE INCREDIBLY
POWERFUL, HOPING THE DIRECTION
YOU WILL CONSIDER AS DR.
DONENBERG BUILDS ON THAT.
BUILDING ON DR. MONTANER'S
QUESTION, TO SEE THE VALUE OF
FEDERAL SUPPORT HERE, TO
OPTIMIZE EFFICIENCY OF
SCIENTIFIC ADVANCES AND ENSURE
THE EFFICIENT USE OF TAXPAYER
DOLLARS, CAN YOU JUST ELABORATE
MORE ON THE CONTRACTING AND HOW
THAT RELATED TO PRICE POINT.
YOU SAID THAT WAS SO VALUABLE
BUT I'M HOPING YOU CAN CLARIFY
WHERE THAT VALUE IS.
>> SO, THE VALUE OF THE
CONTRACTING AS DESCRIBED HERE IS
THE FLEXIBILITY TO ACCELERATE
TECHNOLOGIES ACROSS THE
SPECTRUM, WHETHER THEY BE A
VIRAL LOAD TASK, PARTICULARLY
GENOMIC, OR ANTIGEN TEST IN THE
CASE OF THE COVID I SHOWED AT
THE BEGINNING.
WE NEEDED TO HAVE A FLEXIBLE
CONTRACTING STRUCTURE TO ALLOW
US TO ACHIEVE THOSE THINGS IN AN
UNCERTAIN LANDSCAPE,
PARTICULARLY UNCERTAIN LANDSCAPE
OF THE PANDEMIC.
THE MARKET FORCES WILL DRIVE
YOUR PRICE EVENTUALLY.
I UNDERSTAND ALL OF YOUR
CONCERNS WITH PRICE EQUALING
ACCESSIBILITY.
THE ACCELERATION AT THIS POINT
IS TO REACH A REGULATORY
APPROVAL, AND THEN MARKET FORCES
ONCE WE HAVE THAT AREA FILLED
TEND TO MOVE PRICE IN THE
DIRECTION IT CAN GO.
IF NOTHING IS AVAILABLE THERE IS
NO ACCESS.
>> THANK YOU.
DR. SAWYER?
>> SORRY.
HI, GOOD MORNING.
DR. MULVANEY, THANK YOU FOR YOUR
PRESENTATION.
I'M DEFINITELY IN THE CAMP
HOPING FOR THE MOONSHOT.
I'M ROOTING FOR A HOME TEST TO
EMPOWER PEOPLE TO PROTECT
THEMSELVES AT THE MOMENT WHERE
THEY ARE GOING TO BE DOING
SOMETHING THAT THEY MIGHT GET
EXPOSED.
AND SO, YOU KNOW, WHAT I'M
HEARING YOU SAYING IS THAT
FINGER PRICK BLOOD IS JUST NOT
ENOUGH VOLUME, RIGHT?
LIKE IT'S JUST -- NOBODY IS
EASTBOUND COMING CLOSE TO BEING
ABLE TO DETECT VIRAL LOAD FROM A
FRINGIER -- FINGER PRICK, NOW
YOU REQUIRE INSTRUMENT ICE, --
INSTRUMENTATION.
HAVE THERE BEEN OUTSIDE-THE-BOX
PROPOSALS LOOKING FOR HIV DEBRIS
IN BIOFLUID LIKE URINE OR SALIVA
WHICH CAN BE COLLECTED EASILY AT
HIGHER VOLUMES AND CONCENTRATED?
>> THERE ARE TWO HALVES TO THE
ANSWER I'D LIKE TO PROVIDE TO
YOU.
FIRST HALF IS WE'RE UNCERTAIN AT
THIS POINT WHAT THE LOWER LIMIT
OF QUANTITATION WILL BE.
WHETHER THAT IS GOING TO BE 200
OR SOMETHING AS LOW AS THE 40
THAT CEPHEID SHOWED IN THEIR
GLOBAL PRODUCTS, OR FANTASTIC
-- FANTASTIC
HIGHER, 500 OR 1,000.
I'LL ALLOW INNOVATOR TEAMS TO
PUSH ON THAT PART OF IT.
VERY SENSITIVE ASSAYS ARE
POSSIBLE IN A VARIETY OF
LANDSCAPES.
WE WILL HAVE TO SEE THE
REALITIES OF THAT WITH THE HIV
VIRAL LOAD, OR OTHER ASPECTS OF
HIV CARE.
AND THIS IS SOMETHING THAT I
HAVE EXCITEDLY TALKED TO A
NUMBER OF MY COLLEAGUES AT NIAID
ABOUT, AND OAR ABOUT.
THE PROGRAM HERE WAS
SPECIFICALLY DESIGNED TO BRING A
PRODUCT TO MARKET IN THE POINT
OF CARE SPACE, THAT'S NOT TO SAY
THAT WE'RE AREN'T INTERESTED IN
THE AT-HOME SPACE BUT WITH
NEITHER BEING AVAILABLE AT THE
TIME, WE CHOSE THIS AS THE FOCUS
HEREIN.
WE WOULD NEED TO TALK TO
INNOVATORS ABOUT WHAT THEY CAN
DO AND WHAT IS THE MINIMUM VALUE
THEY CAN DO IT AT.
AND THEN MAP THAT TOWARDS A
REGULATORY PATHWAY THAT COULD
SEEK AN APPLICATION WITHIN THE
UNITED STATES OR GLOBAL MARKET.
SO WE'RE ARE NOT GIVING UP ON
THAT.
THAT'S NOT THE FOCUS.
IS.
>> DR. FLETCHER?
>> COURTNEY FLETCHER.
THANKS FOR YOUR PRESENTATION AND
PROS SHOWN.
MY QUESTION IS HAS ANY
CONSIDERATION BEEN GIVEN TO
PERHAPS AN ACCOMPANYING TEST FOR
MEDICATION ADHERENCE?
I THINK IT'S PROBABLY OBVIOUS
THE INTERPRETATION OF HIGH VIRAL
LOAD IN THE PRESENCE OF NO DRUG
IS VERY DIFFERENT THAN HIGH
VIRAL LOAD IN PRESENCE OF DRUG.
>> I REMAIN OUT OF THE ANSWER TO
THE QUESTION, I WOULD THROW OPEN
TO THOSE MORE EXPERT IN HIV.
I'M MORE OF A PHYSICAL CHEMIST,
AND DEVICE DEVELOPER.
SO MY COLLEAGUES WITHIN POCTRN,
I SHOWED YOU THEY ARE WRITING
THAT MANUSCRIPT FOR DIFFERENT
USE CASE SETTINGS AND THAT THOSE
DIFFERENT USE CASE SETTINGS MAY
HAVE DIFFERENT DEVICE
CONFIGURATIONS THAT ARE
INTERESTING.
SO, DO YOU NEED QUANTITATION,
WOULD QUALITATIVE TESTS BE OKAY?
THOSE ARE THRESHOLD SO LOWER
VOLUMES WOULD BE OKAY.
THERE ARE CONFIGURATIONS OF
CAPABILITY THAT CAN MATCH
DIFFERENT USE SETTINGS, AND I
RELY ON MY HIV COLLEAGUES TO
TELL ME WHAT THEY WOULD LIKE TO
HAVE MADE.
SO, WHAT IS GOING ON IN THE
PROGRAM HERE IS FOCUSED ON ONE
SET OF GOALS.
AND A FUTURE PROGRAM,
PARTICULARLY WITH ENTHUSIASM AND
SUPPORT BEHIND IT COULD GO AFTER
A SECOND GOAL.
>> ANY OTHER COMMENTS OR
QUESTIONS?
I THINK I'LL SORT OF JUST CHIME
IN.
THE REASON I WAS ASKING ABOUT
PLASMA, THERE ARE PUBLICATIONS
WHERE THEY HAVE SHOWN THAT THE
WHOLE BLOOD WILL GIVE YOU A
READING OF VIRAL LOAD WHEN THE
PLASMA WILL BE UNDETECTABLE BY
REGULAR TESTS SO THAT THERE IS A
FRACTION OF THE VIRUS, EVEN IN
PEOPLE ON ADJUVANT TRIAL
THERAPY, THAT ARE SUPPRESSED
OTHERWISE.
BUT THAT DOESN'T EXCLUDE THE
FACT THAT IF YOU'RE TALKING
ABOUT DIAGNOSIS THAT WHOLE BLOOD
MAY BE MORE SENSITIVE TO DETECT
BECAUSE OF THAT COMPONENT THAT
YOU COULD HAVE THE ADDITIONAL
SIGNAL COMING FROM
CELL-ASSOCIATED OR CELL-BOUND
PLATELETS AND WITH PARTICLES.
SO TO THE EXTENT THAT YOU COULD
I GUESS NOT ENCOURAGE BUT
SUGGEST THAT IF THEY ARE
DEVELOPING DEVICES THAT THEY
KIND OF HAVE THE OPTION TO RUN
WHOLE BLOOD OR FILTRATE IT
BECAUSE THERE MAY BE DIFFERENT
APPLICATIONS FOR EITHER ONE.
DEPENDING WHAT THE OBJECTIVE IS,
WHETHER EXPOSURE AND VIREMIA
VERSUS SUPPRESSION UNDER
ANTIRETROVIRAL THERAPY.
>> THOSE ARE ALL EXCELLENT
POINTS.
I WOULD NOTE THAT THE CRS, THE
FDA HAS PUBLISHED THAT WE'RE
WORKING TOWARDS, SAYS THIS IS
NOT FOR DIAGNOSIS, SO THIS IS A
VIRAL LOAD TEST FOR
QUANTITATION, AND THAT'S THE
SORT OF GUIDING THING WITHIN THE
PROGRAM THAT'S ONGOING, ONGOING
DISCUSSION CAN ATTACK DIFFERENT
LEVELS.
>> I GET IT BUT I'M SAYING
QUANTIFICATION WITH NO ANTIBODY
POSITIVITY, YOU'RE QUANTIFYING
VIRUS ANYWAY SO EVEN IF IT'S
QUANTIFICATION MY SUGGESTION WAS
TO MAKE THEM, ENCOURAGE THEM TO
RUN TESTS WITH PLASMA OR WHOLE
BLOOD IF POSSIBLE.
YOU SAID QUANTIFICATION MORE
MONITORING, THERE MIGHT BE OTHER
USES AS THEY DEVELOP THE
TECHNOLOGY.
>> PERFECT, THANK YOU.
>> ANY OTHER QUESTIONS OR
COMMENTS FROM ANYONE?
>> ALL RIGHT.
WE'RE A BIT AHEAD OF AGENDA.
DR. GLENSHAW, CAN WE PROCEED
WITH OUR EXTENDED BREAK?
>> YES.
THAT'S A GREAT IDEA.
>> PERFECT.
THANK YOU.
SO WE'LL NOW PROCEED TO A BREAK,
RECONVENING AT 2:15.
PLEASE COME BACK BY 2:15.
DO NOT LOG OUT FROM THE TEAMS
BUT PUT YOURSELF ON MUTE AND
HIDE YOUR CAMERA.
THAT WAY WE CAN KEEP EVERYONE ON
BOARD.
SEE YOU BACK AT 2:15.
THANK YOU, EVERYONE.
WELCOME BACK, EVERYONE, FROM
OUR BREAK.
AND WE CAN PROCEED NOW WITH OUR
AGENDA FOR TODAY.
AS WE HAVE RECEIVED SUBSTANTIAL
FEEDBACK REGARDING THE SUPPORT
OF THE GUIDELINES, WE DISCUSSED
THIS BEFORE, AND THIS DISCUSSION
IS ONGOING, DR. DAN DONENBERG
WILL SHARE UPDATES AS THE PLAN
FORWARD AT THIS TIME.
DR. DONENBERG?
>> YES, THANK YOU.
I'M GOING TO ADDRESS THE
SUBSTANTIAL INTEREST THAT FOLKS
HAVE HAD IN THE GUIDELINES AND
OUR STRATEGY TO PLAN FOR THEIR
SUSTAINABILITY OVER TIME.
FOR ANYONE IN THE AUDIENCE WHO
ISN'T FAMILIAR WITH THIS, OARAC
COORDINATES FIVE EXPERT WORKING
GROUPS TO DEVELOP THE HIV
CLINICAL PRACTICE GUIDELINES.
AND THE GUIDELINES ARE
RECOMMENDED FOR USE BY THE U.S.
HEALTH CARE PRACTITIONERS AND
INFORM CLINICAL PRACTICE AROUND
THE WORLD AS WELL AS THE U.S. TO
IMPROVE HEALTH OF PEOPLE WITH
AND AFFECTED BY HIV.
SO FOR A LITTLE BIT OF BRIEF
HISTORICAL CONTEXT.
THE GUIDELINES PANELS BECAME THE
WORKING GROUPS OF OARAC IN 2005.
AND FOR SEVERAL YEARS, THE
MANAGEMENT, PUBLICATION AND
DISSEMINATION SUPPORT WAS
PROVIDED BY THE NATIONAL LIBRARY
OF MEDICINE, HERE IN THE FEDERAL
GOVERNMENT.
THEN IN 2020, THE NIH OFFICE OF
AIDS RESEARCH TOOK THEM OVER.
AND, YOU KNOW, HAVING ONLY BEEN
HERE SINCE OCTOBER, IT HAS BEEN
AN INCREDIBLE HONOR FOR OAR TO
CONTRIBUTE TO THE HEALTH OF
PEOPLE AFFECTED BY HIV THROUGH
THE GUIDELINES.
WE'RE INCREDIBLY GRATEFUL FOR
THE SUBSTANTIAL AND DEDICATED
WORK OF THE VOLUNTEERS EXPERTS
WHO DEVELOPED THEM.
WE ABSOLUTELY KNOW THE
LIFE-SUSTAINING VALUE OF THESE
GUIDELINES AND WHAT THEY
PROVIDE, AND WE ARE EAGER TO
ENSURE THAT THEY CONTINUE TO DO
SO.
I WANT TO MAKE THAT REALLY
CLEAR.
THIS IS WHY AMID RECENT EFFORTS
TO STREAMLINE THE FEDERAL
COORDINATION AND REDUCE
SPENDING, OAR FOUGHT VERY HARD
TO PRESERVE FUNDING FOR THE
GUIDELINES.
AND WE WERE ABLE TO SECURE
FUNDING FOR THE NEXT 12 MONTHS.
AFTER THAT TIME WE ANTICIPATE
THAT A MORE LIMITED BUDGET IN
OAR MAY FORCE US TO REALLOCATE
RESOURCES FROM THE GUIDELINES
MANAGEMENT TOWARD ACTIVITIES
DIRECTLY RELATED TO OUR PRIMARY
COORDINATING ROLE OF THE NIH HIV
RESEARCH PROGRAM.
WE SEE THE NEXT YEAR AS A
CRITICAL AND IMPORTANT
OPPORTUNITY TO PLAN FOR
POTENTIAL TRANSITION.
TO THAT END, WE HAD PLANNED TO
CONVENE A DISCUSSION ON THIS
TOPIC TODAY BUT WE WANT YOU TO
KNOW THAT AFTER OUR INITIAL
OUTREACH TO THE GUIDELINE
PANELS, WE RECEIVED SWIFT AND
PASSIONATE RESPONSES, EXPRESSING
CONCERN ABOUT THIS DIRECTION.
AS A RESULT, WE DEEPLY
APPRECIATE THE FEEDBACK WE
RECEIVED FROM PANEL MEMBERS AND
THE THE BROADER COMMUNITY
REFLECTING BOTH INDIVIDUALS AND
ORGANIZATIONS' DEEP DEDICATION
AND EXPERTISE.
AND THE FEEDBACK DROVE TO US
SHIFT PLANS.
THIS WAS NOT MEANT TO ELIMINATE
PUBLIC COMMENT.
IT'S ACTUALLY TO RECEIVE IT IN A
MORE COORDINATED AND THOUGHTFUL
WAY.
SO IN CONSULTATION WITH THE NIH
EXECUTIVE SECRETARIES AND
LEADERS OF THE GUIDELINES, WE
DECIDED TO CREATE ADDITIONAL NEW
OPPORTUNITIES FOR INPUT AND MORE
IN-DEPTH DISCUSSIONS.
SO, WE DECIDED THAT RATHER THAN
FACILITATING AN EXTENDED
DISCUSSION TODAY, BECAUSE TIME
IS REALLY LIMITED IN THIS
MEETING, I'M GOING TO SPEAK
BRIEFLY ABOUT OUR PLANS FOR THE
NEXT STEPS AND THEN ASK
SPECIFICALLY FOR FEEDBACK ABOUT
THOSE PLANS.
WE WILL THEN PRIORITIZE MORE
DISCUSSION WITH SMALLER GROUPS
OF PANEL MEMBERS AND FULLY
EXPLORE TRANSITION OPPORTUNITIES
WITHIN HHS BEFORE BRINGING THE
TOPIC TO THE LARGER OARAC FORUM.
SO, ON THE SCREEN YOU'LL SEE OUR
PLANNED NEXT STEPS TO ENSURE
THAT ANY TRANSITION IS
ABSOLUTELY INFORMED BY INPUT
FROM FEDERAL PARTNERS, GUIDELINE
PANEL MEMBERS, AND THE BROADER
COMMUNITY.
FIRST, WE PLAN TO CONVENE SMALL
GROUP DISCUSSIONS WITH EACH OF
THE GUIDELINE PANELS ABOUT
OPPORTUNITIES TO IMPROVE THE
GUIDELINES AND THE PROCESS TO
DEVELOP THEM.
WE'LL ASK THE LEADERSHIP OF EACH
PANEL TO DRIVE THESE DISCUSSIONS
AND OAR IS ABSOLUTELY AVAILABLE
TO HELP SUPPORT THAT EFFORT.
ULTIMATELY, WE'RE HOPING TO GET
FEEDBACK AND INPUT ON THE
ELEMENTS OF THE GUIDELINES THAT
WE REALLY NEED TO MAINTAIN OR
CHANGE OR MAYBE INITIATE TO
ENSURE THAT THEY REMAIN RELEVANT
ACROSS SETTINGS.
WE WANT INPUT ON OPPORTUNITIES
TO ENHANCE THE ROLE OF THE
COMMUNITY IN THE PROCESS.
WE WOULD LIKE INPUT ON ANY WAYS
TO STREAMLINE AND IMPROVE THE
GUIDELINES MANAGEMENT AND
PRODUCTION AND WE'RE SEEKING
INPUT ON RECOMMENDATIONS FOR
PROCESS ENHANCEMENTS.
FOR EXAMPLE, WHAT'S THE
FREQUENCY OF THE UPDATE AND
MEMBERSHIP STRUCTURE?
WE ALSO WELCOME ANY INPUT ON A
POTENTIAL TRANSITION OF OAR'S
ROLE IN MANAGING AND PRODUCING
THE GUIDELINES.
SIMULTANEOUSLY, WE INVITE PUBLIC
INPUT AT OARACINFO@NIH.GOV.
WE'RE CURRENTLY WORKING TO
DISCUSS THE FUTURE OF THE
GUIDELINES WITH HHS AND OTHER
FEDERAL PARTNERS.
FINALLY, WE'LL REPORT BACK
PUBLICLY AND TO OARAC AT FUTURE
OARAC MEETINGS ON OUR PROGRESS.
I WANT TO EMPHASIZE WE NEVER
INTENDED TO ELIMINATE THE
GUIDELINES.
THAT WAS NEVER THE INTENT.
SO I JUST WANT TO BE CLEAR.
I'M GOING TO STOP HERE TO INVITE
BRIEF COMMENTS ON THESE SPECIFIC
NEXT STEPS FROM OARAC MEMBERS
AND GUIDELINE LEADERSHIP, AND
TO -- SO WE CAN KNOW BEST HOW TO
MOVE FORWARD AND AGAIN I'M GOING
TO ASK EVERYONE TO HOLD ON
ADDITIONAL FEEDBACK FOR THE
SMALLER GROUP MEETINGS WHEN WE
HAVE A MORE IN-DEPTH DISCUSSION.
>> THANK YOU, DR. DONENBERG.
>> SURE.
>> AND IT'S -- YEAH, I MEAN, I
THINK IT'S A VERY GOOD IDEA TO
HAVE THE SMALLER GROUPS BECAUSE
THERE'S A LOT TO DISCUSS AND
IMPLICATIONS OF A TRANSITION AND
HOW TO STREAMLINE IT IS --
SHOULD HAVE A FULL DISCUSSION ON
EACH ONE OF THE WORKING GROUPS.
SO THANK YOU FOR TAKING THE
LEADERSHIP TO MAKE THAT
POSSIBLE, MOVING FORWARD WITH
OAR SUPPORT.
SO, WE'LL START WITH A BRIEF
CLARIFICATION AND DISCUSSION ON
THE PROPOSED PLAN.
SO IS THERE ANY FEEDBACK FROM
THE ROOM AS WE START FIRST?
>> NOT AT THIS TIME.
>> THANK YOU.
WE HAVE ONE ARM, DR. FLETCHER?
>> YEAH, THANKS FOR SOME HELPFUL
CLARIFYING COMMENTS.
I GUESS I DO -- I MAY NOT BE
EXACTLY DOING WHAT YOU WANT ME
TO BUT YOU'RE GOING TO HAVE TO
BEAR WITH ME.
I DON'T HOW OAR VIEWS THIS MAY
BE DIRECTLY RELATED --
>> WE LOST YOU FOR A SECOND.
START OVER.
THAT WASN'T INTENTIONAL.
I HAVE NO CONTROL.
IF YOU COULD START AND SAY THAT
OVER AGAIN PLEASE.
>> I GUESS MY FIRST QUESTION IS
I DON'T UNDERSTAND THE VIEW THAT
OAR SEEMS TO HAVE THAT THIS IS
NOT CENTRAL TO THE MISSION OF
COORDINATING THE HIV RESEARCH
PROGRAM.
IN MY READING, YOU KNOW, THE
MISSION OF THE NIH, YOU KNOW,
THE VERY FIRST BULLET IS TO
FOSTER FUNDAMENTAL DISCOVERIES
AND THEIR APPLICATIONS.
TO ME, THIS IS EXACTLY WHAT THE
GUIDELINES DO.
IN FULL DISCLOSURE, I WAS ON THE
HIV GUIDELINES PANEL FROM 2001
TO 2013.
AND, YOU KNOW, HAVE FIRSTHAND
EXPERIENCE IN THE PANEL TAKING
NIH DISCOVERIES AND TRANSLATING
THEM INTO, YOU KNOW, HOW TO USE
THEM.
SO MEETING THAT, YOU KNOW,
APPLICATION OF DISCOVERY INTO
PRACTICE.
AND SO, YOU KNOW, I'M GOING TO I
THINK STOP THERE, BUT MY CONCERN
IS WITH WHAT IS BEING GIVEN AS
THE PREMISE OF THAT, THAT IT
DOESN'T SEEM TO BE CENTRAL TO
THE OARAC OAR MISSION OF
COORDINATING THE NIH RESEARCH
PROGRAM.
>> THANK YOU.
I APPRECIATE THAT COMMENT.
AND I -- YOU KNOW, I CERTAINLY
UNDERSTAND THAT PERSPECTIVE.
AND WE'RE GOING TO WORK REALLY
HARD TO FIGURE OUT HOW TO MAKE
SURE THAT THEY ARE SUSTAINED,
AND WE CAN DISCUSS THAT FURTHER
AS WE MOVE FORWARD, YOUR
PERSPECTIVE, CERTAINLY.
THANK YOU.
>> LISA BORGI, I APPRECIATE THAT
WILL BE MORE OPPORTUNITY FOR THE
LARGER COMMUNITIES THAT GIVE
FEED BANK REGARDING THIS
PROPOSED TRANSITION.
I THINK THAT'S REALLY IMPORTANT.
I ECHO DR. FLETCHER'S COMMENTS,
I THINK THIS IS CENTRAL TO OAR
AND HAVING OUTLINED THAT
IMPLEMENTATION SCIENCE IS PART
OF WHAT WANTS TO DO GOING
FORWARD.
THEY DO THAT RIGOROUSLY AND I
THINK IT SITS BROADLY.
THERE ARE WAYS TO ENHANCE
EFFICIENCY AND REDUCE COST, I
THINK AS PART OF YOUR PLAN TO
EXPLORE TRANSITION OPPORTUNITIES
WITHIN HHS YOU MAY WANT TO HEAR
HOW DIFFICULT IT IS OUTSIDE HHS.
WE'VE EXPLORED THAT AND THERE'S
NO GOOD FIT THAT WILL MAINTAIN
RIGOROUSNESS, TIMELINESS, AND
ACCESSIBILITY AS WELL AS THE
TRUST AND REPUTATION OF WHAT OAR
IS ABLE TO BRING NOW.
WHICH WILL DE-EMPHASIZE
IMPORTANCE OF HIV IN THE UNITED
STATES OVERALL, WHICH IS NOT THE
GOAL.
IF YOU MOVE THIS TO A SMALLER
ORGANIZATION THAT DOESN'T HAVE
THE REPUTATION OR ABILITY TO
PROVIDE WIDE ACCESS, AGAIN WE'RE
FALLING INTO THE TRAP OF SAYING
SHIV NO LONGER IMPORTANT IN THE
UNITED STATES AND I DID NOT
THINK THAT'S THE MESSAGE THAT
THIS PANEL WANTS TO SEND.
THANK YOU.
>> WE DO NATURAL WANT TO
COMMUNICATE HIV IS NO LONGER
IMPORTANT.
I APPRECIATE THAT.
>> THANK YOU.
DR. GULICK?
>> THANKS FOR BRINGING THIS TO
THE FOREFRONT AND ALLOWING US TO
COMMENT.
I'M THE ACTION CO-CHAIR OF THE
ADULT ADOLESCENT ART GUIDELINES.
THESE GUIDELINES HAVE BEEN IN
POSITION FOR SEVERAL DECADES,
AND PROVIDE AS YOU POINTED OUT
NOT JUST HELPFUL INFORMATION AND
GUIDANCE FOR U.S. PROVIDERS BUT
ACCESSED BY PEOPLE AROUND THE
WORLD.
AT INTERNATIONAL HIV CONFERENCES
PEOPLE WILL REFER TO OUR
GUIDELINES AS BEING THE STANDARD
OF CARE REALLY FOR THE WORLD.
SO THE IMPORTANCE OF THEM, I
ECHO THE PREVIOUS TWO SPEAKERS'
COMMENTS ABOUT HOW IMPORTANT
THEY ARE.
I'D LIKE YOU TO SAY MORE ABOUT
WHAT'S MOTIVATING THIS CHANGE.
THERE ARE TWO THINGS, IF I
UNDERSTAND.
ONE IS THE MISSION OF US.
SECONDLY, IS THIS A FINANCIAL
DECISION HERE?
AND OBVIOUSLY WE ALL LIVE IN THE
CURRENT ENVIRONMENT WHERE
FINANCIAL ISSUES HAVE RISEN TO
THE TOP OF THE LIST.
BUT I WOULD BE INTERESTED TO
HEAR YOU COMMENT MORE WHAT'S
REALLY MOTIVATING THIS BIG
CHANGE.
>> THANK YOU.
IT WAS INITIALLY MOTIVATED BY
THE FINANCIAL CONCERNS THAT HAVE
BEEN RAISED.
AND THAT, YOU KNOW, WITH THESE
BUDGET CUTS AMID ALL OF THESE
BUDGET CUTS WE HAVE TO THINK
ABOUT BOTH SUSTAINING
GUIDELINES, AND SO WE FOUGHT TO
PRESERVE THE FUNDING, BUT WE
ANTICIPATE THAT HAVING THIS MORE
LIMITED BUDGET IS GOING TO FORCE
US TO REALLOCATE THE RESOURCES
FOR THE GUIDELINES TOWARDS
ACTIVITIES MORE DIRECTLY RELATED
TO OUR COORDINATING ROLE.
WHICH IS TO, YOU KNOW, AROUND
THE HIV RESEARCH PROGRAM.
SO THE KINDS OF FUNDS THAT WE
MAKE DECISIONS ABOUT OR THAT WE
ALLOCATE FOR RESEARCH STUDIES
AND PROJECTS LIKE THAT.
BUT, YOU KNOW, WE CERTAINLY HAVE
TO BE RESPONSIVE TO, FOR
EXAMPLE, THE 40% CUT IN THE
BUDGET THAT WAS PROPOSED.
AND ACTUALLY IT WAS NOT 40%
ACROSS THE ENTIRE NIH AND THE
ENTIRE OFFICES.
SOME WERE HIGHER, SOME WERE
LOWER.
SO ...
>> WELL, LISA, IF IT'S OKAY IF I
COULD DO A FOLLOW-UP TO THAT.
I THINK IF YOU LOOK AT THE
BUDGET FOR THOSE GUIDELINES YOU
WILL FIND THAT THERE IS AN
ENORMOUS AMOUNT OF VOLUNTEER
EFFORT THAT HAS BEEN CONTRIBUTED
TO THIS.
ACADEMICS FROM ACROSS THE NATION
WHO VOLUNTEER THEIR TIME TO PUT
INTO THIS.
AND AS I UNDERSTAND IT, THE
SUPPORT FOR THE GUIDELINES
REALLY BOILS DOWN TO THE
ADMINISTRATION AND TO THE
COMMUNICATION OF THE GUIDELINES,
AND I'LL JUST VOLUNTEER THAT I
THINK WE'RE REMARKABLY
STREAMLINED AND EFFECTIVE, COST
EFFECTIVE, IN TERMS OF WHAT
WE'RE DOING.
IF COST WAS MOTIVATING FACTOR
HERE, I WOULD ASK THAT YOU TAKE
A VERY GOOD LOOK AT THAT AND SEE
THE EFFECTIVENESS OF WHAT'S COME
OUT OF THESE FIVE PANELS AND HOW
MUCH MONETARY SUPPORT'S REALLY
GONE INTO IT.
IF IT'S MISSION, THAT'S
IMPORTANT TOO.
BUT MAYBE THOSE TWO THINGS COULD
BE SPLIT WHEN WE TALK ABOUT IT.
AND AS COURTNEY FLETCHER POINTED
OUT ALREADY MUCH OF WHAT WE DO
ON THE GUIDELINES IS ACTUALLY
MISSION DRIVEN HERE.
SO, AGAIN, I LOOK FORWARD TO
FURTHER CONVERSATIONS BUT IF
WE'RE TALKING ABOUT MONEY VERSUS
MISSION, PERHAPS WE COULD FOCUS
ON THOSE TWO ISSUES CAREFULLY.
>> I APPRECIATE THAT.
I THINK DISTINGUISHING THOSE IS
DEFINITELY IMPORTANT.
WE RECOGNIZE ABSOLUTELY AMAZING
VOLUNTEER EFFORT THAT GOES INTO
THESE GUIDELINES.
WE AGREE THEY NEED TO BE
SUSTAINED, THAT THEY ARE VERY
IMPORTANT.
SO THANK YOU.
>> I THINK IT'S CLEAR BASED ON
EVERYONE THAT HAS SPOKEN, THE
COMMITMENT TO MAINTAIN AS YOU
ALREADY HAVE INDICATED THAT IS
ALSO THE COMMITMENT OF OAR TO
MAINTAIN THE GUIDELINES.
THE ISSUES RAISED IS REGARDING,
DR. GULICK JUST STATED, THE
COMMUNICATION AND PERHAPS THE
DISCUSSIONS MOVING FORWARD
SHOULD CLARIFY WHETHER THE
DISCUSSIONS NEED TO INCLUDE THE
ADAPTING WITHIN THE FISCAL
REALITY, THE GUIDELINES WITHIN
OAR OR IS IT REALLY ABOUT THE
TRANSITION OUT AS AN
ALREADY-MADE DETERMINATION.
I THINK THAT MAY CLARIFY THE WAY
FORWARD.
BUT THE CLEAR FROM THE FEEDBACK
THAT OARAC IS PROVIDING YOUR
OFFICE, THE ADVISORY COMMITTEE
IS PROVIDING YOUR OFFICE, THAT
THERE'S STILL SOME SORT OF
ADVOCACY OR CONCERN OR
RECOMMENDATION THAT THE BENEFITS
OF MAINTAINING IT WITHIN YOUR
OFFICE MAY STILL BE WORTH
CONSIDERING RELATIVE TO HOW THEY
WOULD BE MAINTAINED WHICH COULD
BE STREAMLINED EVEN WITHIN THE
EXISTING OFFICE.
SO PROVIDING SOME GUIDANCE ON
THAT TOWARDS THE WORKING GROUPS
WOULD BE REALLY HELPFUL BECAUSE
IT SEEMS THE COMMENTS ARE STILL
SORT OF ARTICULATING THIS
QUESTION AS BEING PERHAPS STILL
OPEN FOR DISCUSSION.
BUT IF THERE'S AN ADDITIONAL
POINT --
>> MAY I RESPOND?
>> PLEASE.
>> I WANT TO REITERATE NO FINAL
DECISION HAS BEEN MADE.
I WANT TO MAKE THAT REALLY
CLEAR.
THERE'S NO FINAL DECISION THAT
HAS BEEN MADE ABOUT WHERE THE
GUIDELINES ARE GOING TO BE.
THE SECOND POINT I WOULD MAKE IS
LOOKING AT OUR PLANS, THE REASON
WE HAVE THOSE STEPS IN PLACE IS
TO BASICALLY ADDRESS HOW WE --
IF THE PERCEPTION OR IF THE
ISSUES ARE FINANCIAL, WHERE CAN
THERE BE STREAMLINING OF SOME OF
THESE PROCESSES AND SOME OF
THESE SUPPORTS SO THAT THEY --
SO THEY ARE MORE MANAGEABLE AND
MORE EFFICIENTLY PRODUCED AND
MORE EFFICIENTLY DISSEMINATED.
SO, JUST WANTED TO PUT THAT OUT
THAT OUR HOPE IS THAT SOME OF
THE STEPS WE'VE LAID OUT WILL
ACCOMPLISH THAT.
AND PROVIDE THAT KIND OF
DIRECTION.
I HEAR YOU AND JUST WANT TO MAKE
CLEAR NO FINAL DECISION HAS BEEN
MADE ABOUT WHERE THE GUIDELINES
WOULD LIVE.
>> IS IT CORRECT TO INTERPRET
THAT OARAC COULD BE ONE OF THOSE
LOCATIONS STILL IN THE FUTURE?
>> YES.
>> OKAY.
SO GETTING THE FINANCIAL ASPECT
ADDRESSED WITHIN THE CONTEXT OF
STAYING WITHIN THE EXISTING
STRUCTURE IS STILL AN OPTION?
>> IT IS STILL AN OPTION.
>> THANK YOU.
I'M SORRY TO MISPRONOUNCE YOUR
PEOPLE IN.
>> LISA IS FINE.
A FINAL POINT, EVEN AS CO-PANEL
LEADERSHIP, I'M NOT CLEAR ON THE
BUDGET.
AND SO IF WE'RE GOING HAVE
DISCUSSIONS THAT ARE PRIMARILY
FINANCIALLY DRIVEN, THERE NEEDS
TO BE SOME TRANSPARENCY ABOUT
WHAT IS THE BUDGET, WHERE DOES
IT GO TO, BECAUSE WE CAN'T TELL
YOU HOW WE CAN ENHANCE
EFFICIENCY IF WE DON'T KNOW
WHERE THE MONEY IS SPENT OR WHAT
PROPORTION OF OAR IT IS TAKING
SO I THINK THAT WOULD BE AN
IMPORTANT PIECE OF THIS
DISCUSSION.
>> THANK YOU.
AND I COMPLETELY AGREE.
>> THANK YOU.
WE'VE REACHED THE END OF THE
ALLOTTED TIME.
THANK YOU, EVERYONE, FOR YOUR
COMMITMENT TO THE FIELD AND TO
EVERYONE THAT IS BENEFITING AND
DEPENDS ON THE GUIDELINES.
THE COMMITMENT FROM THE PANEL
AND WORKING GROUPS AND OAR IS
REALLY WITHOUT QUESTION.
THE QUESTION IS HOW TO PRESERVE
THE BENEFIT FOR EVERYONE WITHIN
THE CURRENT ENVIRONMENT.
THANK YOU TO PANEL LEADERS AND
OARAC MEMBERS AND EVERYONE FOR
YOUR INPUT AND WE LOOK FORWARD
TO WORKING GROUPS BEING A
PRODUCTIVE DIRECTION TO MAINTAIN
THE GUIDELINES.
AND THE IMPORTANT ROLE THEY PLAY
FOR PEOPLE LIVING WITH HIV.
WITH THIS WE'LL PROCEED TO OAR
UPDATES, SO WE'LL NOW HEAR BRIEF
UPDATES SO DR. JULIO ALBERTI,
ACTING SCIENCE TEAM LEAD, AND
DR. DAVID CHANG, HEALTH
SCIENTIST ADMINISTRATOR, OFFICE
OF AIDS RESEARCH, WILL PROVIDE
UPDATES ON RECENT ENGAGEMENTS
FROM OAR INNOVATION AND EARLY
CAREER INVESTIGATORS PROGRAM.
SO DR. ALBERTI FIRST, PLEASE,
AND THEN WE'LL MOVE ON TO DR.
CHANG.
>> GOOD AFTERNOON.
I'M JULIO ALBERTI, SENIOR
SCIENCE ADVISER, INNOVATION IN
HIV RESEARCH SYMPOSIUM.
EVERY YEAR OAR DEVELOPED THIS
PROCESS TO AWARD MERITORIOUS
PROJECTS THAT BRING INNOVATIVE
APPROACHES TO ADDRESS HIGH
PRIORITY OPPORTUNITIES IN
HIV/AIDS RESEARCH.
THESE ARE CONSIDERED HIGH RISK,
HIGH REWARD APPLICATIONS.
AND THEY ARE PROVIDED TO US,
THEY ARE SUBMITTED TO US BY
INSTITUTES, CENTERS, AND
OFFICES, AND WE CONSIDER THEM
FOR FUNDING.
TO BE CONSIDERED FOR FUNDING
THESE APPLICATIONS NEED TO BE
ALIGNED WITH THE HIV/AIDS
RESEARCH PRIORITIES.
AND WHICH ALSO INCLUDE STRATEGIC
PLAN AND PROFESSIONAL JUDGMENT
BUDGET.
SEVERAL TYPES OF APPLICATIONS
CAN BE BROUGHT UP FOR
CONSIDERATION UNDER THE
INNOVATION PROGRAM.
I WILL SPEAK SPECIFICALLY ABOUT
INTRAMURAL PROJECTS.
TOTAL HIV RESEARCH IN INTRAMURAL
PROGRAM IS 12% OF THE --
APPROXIMATELY 12% OF THE NIH HIV
RESEARCH BUDGET.
AND UNDER THE INNOVATION
PROGRAM, WE HAVE BEEN AWARDING
SOMEWHERE BETWEEN 19 AND 25
INTRAMURAL PROJECTS SINCE FISCAL
YEAR 22.
TOTAL AMOUNT OF FUNDING FOR
THESE INTRAMURAL PROJECTS RANGE
FROM 11 TO $14 MILLION, FROM 22
TO 24.
AND SEVERAL INSTITUTES
PARTICIPATE IN THIS EFFORT.
AND THESE ARE LISTED HERE,
NIAID, NCI, NIDDC, NINDS, NIEHS,
AND NATIONAL LIBRARY OF
MEDICINE.
EXTRAMURAL AWARDS AND CONTRACTS
ARE EXTENSIVELY FOLLOWED UP AND
DOCUMENTED.
THIS IS NOT TRUE, NOT OBVIOUS
FOR INTRAMURAL PROJECTS.
AND ONCE INTRAMURAL AWARDS ARE
MADE, UNDER THE INNOVATION
PROGRAM, WHAT HAPPENS IS THEY
GET DILUTED IN THE ENTIRE
PRODUCTION OF THESE LABS.
INTRAMURAL LABS ARE HIGHLY
PRODUCTIVE, AND SO, YOU KNOW,
OUR CONTRIBUTION SOMETIMES GETS
DILUTED AND WE CANNOT PINPOINT
THE IMPACT OF OUR PROGRAM,
INTRAMURAL PROGRAM.
ONE SOLUTION PROPOSED WAS CREATE
SYMPOSIUM WHERE WE BRING
AWARDEES FOR THE PAST YEAR TO
PRESENT THE SCIENTIFIC PROGRESS
OF THEIR WORK PROPOSED.
THIS SYMPOSIUM IS AN OPPORTUNITY
NOT JUST TO PRESENT THEIR
RESEARCH ADVANCES BUT ALSO TO
COALESCE CRITICAL MISS AMONG THE
INTRAMURAL HIV INVESTIGATORS.
AND NEW COLLABORATIONS HAVE
FLOURISHED SINCE WE STARTED THE
SYMPOSIA.
WE HAVE A GREATER FOCUS ON THE
IMPACT OF THESE RESEARCH
FINDINGS WHEN THEY ARE PRESENTED
IN THE SYMPOSIUM FORMAT.
AND HIV RESEARCH AS WE'VE SEEN,
EVER SINCE THE '80s, IT HAS A
VERY BROAD, FROM CELLS TO
COMMUNITIES.
WE CAN SEE INAUGURAL SYMPOSIUM
THAT WE STARTED IN 2023, AS YOU
CAN SEE HERE FOR AGENDA OF THE
PROGRAM IT HAS A WIDE RANGE OF
TOPICS THAT WERE COVERED FROM
TESTING TO VACCINES TO CANCER TO
BASIC CELL BIOLOGY AND VIROLOGY,
INVASION OF CELLS AND SO FORTH.
THE SAME WAS TRUE IN THE SECOND
YEAR, THE SECOND YEAR WE HAD A
BIGGER PROGRAM.
THESE ARE SEVERAL -- ALL THE
AWARDEES.
SOMETIMES THEY SEND THEIR JUNIOR
INVESTIGATORS THAT ARE ACTUALLY
DOING THE WORK TO PRESENT THE
WORK TO US SO IT'S AN
OPPORTUNITY FOR EXPOSURE AND
LEARNING FOR YOUNG
INVESTIGATORS.
AND WHEN YOU PUT IT ALL TOGETHER
YOU CAN SEE THE RANGE OF TOPICS
THAT HAVE BEEN COVERED IN THESE
TWO YEARS OF THE INNOVATION AND
HIV RESEARCH SYMPOSIUM.
YOU CAN SEE HERE MICROBIOME,
CANCER, KAPOSI SARCOMA,
VACCINES, AND SEVERAL OTHER
TOPICS ARE ALL COVERED IN THIS
WORD CLOUD.
AND WE COME TO THE CURRENT
VERSION OF THE INNOVATION IN HIV
RESEARCH SYMPOSIUM.
SO WE TRY TO MATCH THE PERIOD
WHERE THE NIH RESEARCH FESTIVAL
HAPPENS.
SO DURING THE DAYS WHERE
RESEARCH FESTIVAL IS HAPPENING,
WE TRY TO BRING THE
INVESTIGATORS TOGETHER AND
PRESENT THEIR WORK.
WE HAVE FOR THIS YEAR IT'S GOING
TO BE ON SEPTEMBER 10, FROM 9:30
TO 4:30.
IT'S A HYBRID EVENT SO PEOPLE
CAN ATTEND ONLINE.
AND THEY CAN COME HERE IN
FISHERS LANE TO SEE IN PERSON IF
THEY WANT TO.
THE AGENDA IS BEING FINALIZED,
CALENDAR INVITATIONS WILL BE
SENT SOON TO ALL PARTICIPANTS OF
OARAC.
WE HAVE ABOUT 18 PRESENTATIONS
FROM INTRAMURAL INVESTIGATORS
AND THEY ARE SHOWCASING THE
RESULTS THAT THEY GATHERED SINCE
THEY WERE AWARDED IN 2024.
SO WE WOULD LIKE TO ASK OARAC
MEMBERS' INPUT.
WE WOULD LIKE TO SEE YOUR
RECOMMENDATIONS FOR WHAT METRICS
SHOULD WE USE TO EVALUATE
LONG-TERM IMPACT OF THE
INNOVATION PROGRAM FUNDING.
HOW CAN THE INNOVATION PROGRAM
BETTER SUPPORT
CROSS-DISCIPLINARY TEAMS AND
WHOLE-PERSON RESEARCH
APPROACHES, INTEGRATING MENTAL
HEALTH, STIGMA, HOUSING.
WHAT ARE YOUR RECOMMENDATIONS TO
ENHANCE VISIBILITY,
COLLABORATION, OR POLICY IMPACT
OF THE ANNUAL INNOVATION IN HIV
RESEARCH SYMPOSIUM?
AND FINALLY WHAT ARE THE
EMERGING SCIENTIFIC OR POLICY
TRENDS THAT OAR SHOULD PREPARE
FOR WITHIN THE INNOVATION
PROGRAM FRAMEWORK?
THANK YOU.
>> DR. CHANG, YOU CAN PROCEED,
AND THEN WE'LL HAVE DISCUSSION
AFTERWARDS.
>> HELLO, I'M DAVID CHANG,
SENIOR SCIENCE ADVISER, OFFICE
OF AIDS RESEARCH, I LEAD THE
EARLY CAREER INVESTIGATORS
SIGNATURE PROGRAM.
TODAY I'M EXCITED TO SHARE SOME
UPDATES ON OUR EFFORTS TO
SUPPORT EARLY CAREER
INVESTIGATORS IN HIV.
THIS INITIATIVE IS A
COLLABORATIVE EFFORT ACROSS
MULTIPLE NIH INSTITUTES,
CENTERS, OFFICES, AND IT'S TRULY
A LABOR OF LOVE THAT WE ALL
PRIORITIZE.
I'LL SPEAK ON BEHALF OF OUR ECI
WORKING GROUPS AT OAR, AND THE
NIH AIDS EXECUTIVE COMMITTEE.
I WANT TO ACKNOWLEDGE MY
COLLEAGUE LIZ KAYLOR FOR
STANDING UP THE PROGRAM AND
BUILDING IT TO WHAT IT IS TODAY.
SO IN MY PRESENTATION I'LL
EXPLAIN WHY SUPPORTING ECI,
EARLY CAREER INVESTIGATORS, IS
CRUCIAL.
WE'LL REVIEW PROGRESS AND
HIGHLIGHTS FROM 2024, DISCUSS
EFFORTS TO EXPAND SUPPORT AND
OUTREACH AND OUTLINE HOW WE'RE
LISTENING TO THE ECI COMMUNITY
IN 2025 TO PLAN FOR THE FUTURE.
FIRST LET'S CLARIFY TERM
FOLLOWING.
WE USE THE EARLY ECI, EARLY
CAREER INVESTIGATORS, PURSUING
FIRST RESEARCH AWARD, R01 OR
EQUIVALENT.
TWO YEARS POST-RECEIPT OF FIRST
INDEPENDENT AWARD, BROADER THAN
THE NIH DEFINITION OF ESI WHICH
INCLUDES RESEARCHERS WITHIN TEN
YEARS POST COMPLETION OF
TERMINAL RESEARCH DEGREE OR
CLINICAL TRAINING.
ESI DEFINED BY NIH, APPLICATIONS
OR CLUSTERED IN PEER REVIEW,
PRIORITIZED FOR FUNDING IF
MERITORIOUS.
>> GIVE US ONE MINUTE, FOLKS.
>> WE'RE BACK.
ECI, PRIORITY ACROSS NIH,
SUPPORTING THEM IS NOT JUST
ABOUT GROWING THE PIPELINE; IT'S
ABOUT ENSURING THE FUTURE OF HIV
RESEARCH AS DIVERSE, INNOVATIVE,
SUSTAINABLE ACROSS MULTIPLE
DISCIPLINES THAT COLLABORATE TO
ADVANCE HEALTH OF PEOPLE LIVING
WITH HIV OR IMPACTED BY HIV.
NOW, GOAL WITHIN THE CURRENT
STRATEGIC PLAN FOR HIV AND
RELATED RESEARCH PERSISTING IS
COMMITMENT TO BUILD AND
STRENGTHEN CAPACITY TO DEVELOP
THE NEXT GENERATION OF HIV
RESEARCHERS.
OUR CURRENT APPROACH IS INFORMED
THROUGH LISTENING SESSIONS FOR
PARTNER OUTREACH AND ENGAGEMENT,
IN 2021 AND 22 OAR HELD
LISTENING SESSIONS ON A VARIETY
OF TOPICS WHICH INCLUDED ONE ON
SUPPORTING ECIs, AND LED TO
THE DEVELOPMENT OF SEVERAL
ACTION STEPS.
ANALYZING ECI AWARDS AND
TRAJECTORIES, ENGAGING WITH
WORKING GROUP, ORGANIZING
WORKSHOPS, INTEGRATING PARTNER
FEEDBACK AND MAINTAINING
PARTNERSHIPS WITH ICOS TO
SUPPORT DIVERSE DISCIPLINES AND
INSTITUTIONS.
HERE WE HAVE A BAR CHART SHOWING
THE NUMBER OF R01 OR EQUIVALENT
AWARDS TO ESI BY FISCAL YEAR.
RED BARS REPRESENT ESI IN HIV
RESEARCH AND BLUE BARS REPRESENT
ESI ACROSS ALL NIH RESEARCH.
OF THE NUMBER OF THE AWARDS
FLUCTUATES YEARLY AVERAGING 57
OVER THE PAST SEVEN YEARS.
FUNDING FOR ESI IN HIV IS 5
PERCENT OF THE HIV BUDGET.
SIMILAR TO NIH-WIDE TRENDS.
IF YOU THINK ABOUT THE RELATIVE
NUMBER OF NEWLY AWARDED ESI IN
HIV, IT'S SMALL.
IT'S MODEST.
SO RETENTION AND SUPPORT FOR
THESE INVESTIGATORS ARE CRUCIAL.
SO WHAT MAKES ECI SUCCESSFUL?
IN 2024 OAR ORGANIZED DIRECTOR'S
SEMINAR TO SHOWCASE IMPACTFUL
RESEARCH CONDUCTED BY AN ESI,
HIGHLIGHTING THEIR INCREDIBLE
POTENTIAL OFFERING INSIGHTS FOR
THE NIH.
WE FEATURED DR. SARAH WEIBEL
FROM UCSD WHO BEGAN WITH THREE
SMALL AWARDS IN 201 7 AND 2018
AND HER CAREER TOOK OFF.
OVER THE NEXT FOUR YEARS SECURED
TWO R01s AS P.I., ONE P30 AS
CO-P.I., ONE P01 AS PROJECT
P.I., MENTOR FOR ONE T32.
DESPITE THE CHALLENGES OF THE
COVID-19 PANDEMIC, SHE
SUCCESSFULLY OBTAINED
$9.88 MILLION IN NIH FUNDING,
DIRECT COSTS.
DR. GIANELLA HOLDS SEVERAL
APPOINTMENTS, DIRECT CORES AND
LACKS IN CFAR AND ATG AND
CO-DIRECTS LAST GIFT STUDY, AND
SHE'S ORIGINALLY FROM
SWITZERLAND, SHE COMPLETED HER
MEDICAL GRIEF IN ZURICH BEFORE
MOVING TO THE UNITED STATES FOR
POSTDOCTORAL POSITION AT UCSD.
DIRECTOR SEMINAR PRECEDED ANNUAL
OAR WORKSHOP FOR ECI IN HIV, WE
STARTED IN 2022.
ATTENDANCE HAS GROWN FROM 145
REGISTRANTS IN 2022 TO 1168 IN
2024.
WE CONTINUOUSLY COLLECT FEEDBACK
TO EVOLVE THE PROGRAM TO MEET
ECI NEEDS.
WHICH FOLLOWING THE END OF THE
2023 ECI WORKSHOP WAS FOR MORE
ACCESS TO NIH INFORMATION,
RESOURCES AND STAFF
INTERACTIONS.
THE 2024 WORKSHOP INVOLVED
COLLABORATION WITH 18 NIH ICOS,
FEATURED 9 NIH PRESENTATIONS ON
NIH BASICS, OAR, DEMYSTIFYING
PROGRAM AND PEER REVIEW.
WE INTRODUCED BREAKOUT ROOMS
WITH 40 STAFF LEADING
DISCUSSIONS AND FIELDING Q&A.
WE INVITED SIX EXTRAMURAL
INVESTIGATORS TO SHARE MENTORING
EXPERIENCES ACROSS CAREER STAGES
FROM ECI TO MID-CAREER TO
ESTABLISHED P.I.s.
WE INTENTIONALLY INCLUDED
INVESTIGATORS FROM DIVERSE
FIELDS, BASIC, CLINICAL,
DOMESTIC AND INTERNATIONAL,
BACKGROUNDS INCLUDING ONE FIRST
GENERATION SCHOLAR.
INTEREST IN THE 2024 WORKSHOP
WAS STRONG WITH, AGAIN, 42.9
DOMESTIC, 35 U.S. STATES, PLUS
D.C. AND PUERTO RICO.
56.8% INTERNATIONAL.
SPANNING 48 COUNTRIES ACROSS ALL
THE CONTINENTS EXCEPT
ANTARCTICA.
NOW, FEEDBACK SURVEYS REVEALED
PARTICIPANTS FIELDS OF INTEREST
AND NIH APPLICATION HISTORY, TOP
FIELDS INCLUDED HIV-ASSOCIATED
COMORBIDITIES, CO-INFECTIONS,
COMPLICATIONS.
HEALTH DISPARITIES, HIV CURE,
AGING, WOMEN'S HEALTH, VACCINES,
RESERVOIR AND LATENCY, AND NEXT
GENERATION THERAPIES.
ABOUT 27% HAD EVER APPLIED FOR
AND INDEPENDENT AWARD SUCH AS
R01, 18% RECEIVED NIH FUNDING
FOR ANY AWARD.
ATTENDEES RATED SATISFACTION
WITH THE WORKSHOP COMPONENTS
HIGHLY, 100% LEARNED NEW
INFORMATION.
97% WOULD RECOMMEND TO A
COLLEAGUE.
WE RECEIVED SUGGESTIONS FOR
FUTURE TOPICS.
I'D LIKE TO POINT OUT MATERIALS
FROM LAST YEAR INCLUDING
EXECUTIVE SUMMARY AND VIDEO
CLIPS ARE AVAILABLE ON THE OAR
WEBSITE AND THROUGH THE QR CODE
AND LINK ON THE SCREEN.
IN 2024 THE OAR IN COLLABORATION
WITH ICO PARTNERS MADE CONCERTED
EFFORT TO PRIORITIZE ECI
OUTREACH AT EVERY NIH
PARTICIPATING MEETING AND
CONFERENCE.
AT THE INTERNATIONAL WORKSHOP ON
AGING AND HIV HELD ON OCTOBER 24
IN WASHINGTON, D.C., THE OAR AND
NIMH ORGANIZED ECI SPOTLIGHT
SYMPOSIUM AND THIS FEATURED FOUR
ECIs FROM DIVERSE RESEARCH
BACKGROUNDS, GAVE THEM A
PLATFORM TO SHOWCASE ECI-LED
RESEARCH, SIGNIFICANT CHALLENGES
RELATED TO HIV AND AGING.
IN COLLABORATION WITH 13 ICO
PARTNERS, OAR PRODUCED
CUSTOMIZABLE INFO GRAPHICS FOR
THE ECI SYMPOSIUM AT AGING IN
HIV AND OTHER EVENTS.
THESE ARE DESIGNED TO HELP ECI
AND INVESTIGATORS NEW TO HIV
NAVIGATE NIH HIV RESEARCH
PROGRAM.
HERE ARE EXAMPLES FOR NICHD,
NIDA, ORWH, AND NIAAA.
INFORMATION WAS GATHERED FROM
THE ICOS, DESIGNING LAYOUT AND
GRAPHICS.
EACH INFOGRAPHIC INCLUDES
DETAILS ON THE ICO MISSION,
HIV/AIDS PROGRAM, TRAINING AND
FUNDING OPPORTUNITIES FOR
ECIs, AND ALWAYS A POINT OF
CONTACT E-MAIL.
THROUGHOUT 2024 AND CONTINUING
INTO RECENT MONTHS IN 2025, OAR
STAFF HAS TAKEN ECI OUTREACH ON
THE ROAD, VIRTUALLY AND IN
PERSON, TO MULTIPLE AUDIENCES.
MY COLLEAGUES HAVE BROUGHT
RESOURCES WITHIN SETTINGS
THROUGH FOCUSED TALKS AND WITHIN
BROADER PRESENTATIONS, AND HERE
YOU CAN SEE THE TITLES AND
LOCATIONS, THEY HAVE MET WITH
WOMEN'S HEALTH SCHOLARS, MIAMI
CFAR, JOHNS HOPKINS
IMPLEMENTATION SCIENCE
FELLOWSHIP, AND INTERNATIONAL
SYMPOSIUM ON NEUROVIROLOGY.
PLANNING FOR THIS YEAR BEGAN IN
JANUARY, PAUSED DUE TO
COMMUNICATIONS HALT AT NIH.
WHICH WAS ONE OF MANY
DISRUPTIONS AND UNCERTAINTIES WE
FACED.
IN RESPONSE TO WORKING GROUP,
DEVISED TWO-PART ENGAGEMENT
STRATEGY.
FIRST LISTENING SESSIONS WITH
ECI AND HIV RESEARCH THAT GATHER
INSIGHTS INTO NEEDS AND
CHALLENGES IN THE CURRENT
CLIMATE.
SECOND, ECI WORKSHOP TAILORED TO
ADDRESS FEEDBACK RECEIVED
PROVIDING MORE RELEVANT AND
TIMELY GUIDANCE.
THE LISTENING SESSIONS WERE
DESIGNED TO INFORM
RECOMMENDATIONS FOR FUTURE
WORKSHOPS, RESOURCES, TRAINING,
FUNDING OPPORTUNITIES.
WE INVITED ECIs WHO APPLIED
FOR NIH AWARDS IN THE PAST TWO
YEARS.
WITHIN DAYS, 170 PARTICIPANTS
CONFIRMED ATTENDANCE.
WE ORGANIZED SIX 90-MINUTE
LISTENING SESSIONS, AND WE SENT
THEM ESSENTIAL DISCUSSION
PROMISE ON THE SCREEN IN
ADVANCE.
THE SESSIONS FEATURED OPEN-ENDED
QUESTIONS, TO EXPLORE AREAS
WHERE NIH COULD OFFER
ASSISTANCE.
WE'VE ALREADY HELD THREE
SESSIONS THIS WEEK.
AND WILL CONDUCT THREE MORE NEXT
WEEK.
OUR FEEDBACK THAT WE COLLECT
WILL BE AGGREGATED INTO
COMPREHENSIVE SUMMARY, AND WE'VE
ALSO INCLUDED A INFORMATION ON
PARTICIPANTS BACKGROUNDS AND
LOOK FORWARD TO SHARING RESULTS
SOON.
WE'RE EXCITED FOR THE 2025 ECI
WORKSHOP, INVITE YOU TO SAVE THE
DATE FOR FRIDAY, SEPTEMBER 26.
PLANNING IS WELL UNDERWAY.
WE'RE LOOKING FORWARD TO
CONNECTING WITH ECIs AGAIN
SOON.
IN THE TIME REMAINING I HAVE
SOME QUESTIONS FOR OARAC INPUT.
WE'RE EAGER TO EXPAND OUR
OUTREACH BUT RECENT CHANGES HAVE
REQUIRED US TO ADAPT.
SIGNIFICANT CHALLENGE WE FACE IS
IN THE PROMOTION AND
CROSS-PROMOTION OF EVENTS, AS
OUR COMMUNICATION SUPPORT IS
LIMITED AND OUR SOCIAL MEDIA
ENGAGEMENT HAS BEEN CENTRALIZED
IN NIH.
WITHOUT OUR COMMUNICATIONS
APPARATUS WE NEED TO EXPLORE
ALTERNATIVE STRATEGIES.
PROMPT NUMBER 1 IS WHAT ARE
EFFECTIVE WAYS TO PROMOTE AND
CROSS-PROMOTE EVENTS AND
RESOURCES FOR ECI?
ADDITIONALLY WE SEEK NEW
OPPORTUNITIES FOR NIH TO ENGAGE
WITH ECIs VIRTUALLY AND IN
PERSON.
WE AIM TO REACH GROUPS THAT ARE
NOT NECESSARILY LOCATED IN MAJOR
HIV RESEARCH HUBS OR AFFILIATED
WITH CFARs OR ARTs.
TO INVITE ATTENDEES TO THE ECI
LISTENING SESSIONS, WE PUT THAT
THROUGH THE CFARs TO
DISTRIBUTE, AGAIN BECAUSE WE
HAVE LIMITED COMMUNICATIONS
ABILITY RIGHT NOW.
NUMBER 2 HERE, WHAT ARE OTHER
OPPORTUNITIES FOR NIH TO ENGAGE
WITH ECI, VIRTUALLY OR IN
PERSON.
I'LL STOP THERE.
THANK YOU VERY MUCH.
>> THANK YOU BOTH.
I THINK YOU OBVIOUSLY ARE
ADDRESSING CRITICAL AREAS TO THE
PIPELINE AND TO THE
SUSTAINABILITY OF OUR EARLY
STAGE INVESTIGATORS, WHICH WE
ALL WANT TO RETAIN AND FOSTER
AND WITHIN THE CURRENT
ENVIRONMENT I THINK WE NEED TO
MAKE SURE TO MAKE AN EXTRA
EFFORT TO TAKE CARE AND SUPPORT
THEM.
WE HAD BOTH PRESENTATIONS TO ASK
FOR FEEDBACK, MULTIPLE AREAS.
SO I WILL OPEN THIS UP FOR
INPUT.
WE CAN START WITH THE ROOM.
IS THERE ANYONE IN THE ROOM THAT
WANTS TO CHIME IN?
>> NOT AT THIS TIME.
>> ALL RIGHT.
SO WE'LL GO FOR OARAC MEMBERS.
WE CAN START;
[CROSSTALK]
>> WE HAVE SOMEBODY THAT NEEDS
TO GO ON MUTE.
I DON'T CONTROL IT.
>> I APPRECIATED BOTH TALKS.
AND SOMEONE WHO HAS DIRECTED
PIPELINE PROGRAMS FOR MORE THAN
30 YEARS, UNFORTUNATELY THEY
HAVE ALL BEEN TERMINATED.
I'M ALSO A P.I. ON A T32 THAT'S
ON PAUSE.
I MEAN, HOW CAN YOU GIVE US
ASSURANCES THAT THOSE WILL BE
RESTORED?
THEY WILL BE THE PIPELINE TO
THIS EARLY CAREER INVESTIGATORS,
SO DO YOU HAVE ANY ADVICE WHAT
WE SHOULD DO?
YOU JUST HOLD TIGHT AND LOSE A
GENERATION OF TRAINEES?
I MEAN, THIS IS PROBABLY THE BIG
ELEPHANT IN THE ROOM BUT AS
SOMEONE WHO HAS HAD ALL OF MY
TRAINING GRANTS SUSPENDED, I
WORRY VERY MUCH ABOUT LOSING THE
PIPELINE THAT WILL FEED INTO THE
EARLY CAREER INVESTIGATORS.
>> ARE YOU DIRECTING THIS
QUESTION TO DR. ALBERTI OR DR.
CHANG?
WE CAN'T COMMENT ON FUNDING.
>> NO, NO, I KNOW.
>> AGAIN, IN FEEDING THE
PIPELINE, BUILDING A PIPELINE
FOR EARLY CAREER INVESTIGATORS,
HOW SHOULD WE APPROACH THE
FUNDING?
AGAIN, I'M NOT ASKING ABOUT
FUNDING, I'M ASKING ABOUT MAYBE
GUIDELINES OR ADVICE HOW SHOULD
WE PROCEED.
>> I THINK IT'S A VERY IMPORTANT
CONCERN IF WE LOSE OUR ECI RIGHT
NOW WHO IS LEFT TO TRAIN THE
NEXT GENERATION AFTER THEM?
WE'RE STARTING WITH ECI IN THE
LISTENING SESSION BECAUSE WE
FEEL THEY ARE AT THE CUSP OF
LEADING.
WE CAN READ THAT ALL OVER THE
PLACE AND WRITE IT IN OTHER
FORMS.
WE HEAR IT IN THE LABS, IN
DIFFERENT CONFERENCES.
WHAT WE'RE DOING WITH LISTENING
SESSIONS WILL HOPEFULLY HELP US
INFORM WHAT TO DO NEXT.
AND PERHAPS VOICES RAISED WILL
EMPHASIZE THE NEED FOR SUSTAINED
FUNDING.
BUT ADVICE WE HAVE NOW IS FOR
INVESTIGATORS TO TALK WITH
PROGRAM OFFICERS TO SEE WHAT IS
AVAILABLE AND PERHAPS FIND
CREATIVE WAYS FOR THE TRAINING
TO HAPPEN.
PERHAPS WITH OTHER MECHANISMS.
WE LOOK FORWARD TO PUTTING OUT
THIS COMPREHENSIVE SUMMARY OF
THE LISTENING SESSIONS.
I THINK IT'S OUR FIRST CHANCE TO
DOCUMENT ALL OF THE DIFFERENT
CHALLENGES OCCURRING RIGHT NOW.
AND WE HOPE TO JUST PUT IT OUT
THERE, SO THAT WE CAN LOOK AT IT
FROM ALL ANGLES.
>> THANK YOU.
>> THANKS SO MUCH.
AND THIS IS A COMMENT FOR DAVID,
INTERESTED IN YOUR THOUGHTS
THERE.
YOU KNOW, WE HAVE A CONCERN JUST
IN TERMS OF THE OVERALL LEVEL OF
INTEREST IN INFECTIOUS DISEASES,
AMONG PEOPLE WHO ARE BECOMING
PHYSICIANS.
AND THEN THAT HAS IMPLICATIONS
FOR ADDRESSING HIV.
AND, YOU KNOW, LIMITATIONS IN
THE PIPELINE MAY START MUCH
FURTHER UPSTREAM THAN EARLY
STAGE INVESTIGATORS.
AND SO ONE QUESTION I'VE HAD,
HAS OAR CONSIDERED HAVING A
PRESENCE AT MEDICAL SCHOOL
RESEARCH DAYS WHERE MEDICAL
STUDENTS ARE PRESENTING THEIR
RESEARCH AND ENHANCING THE
VISIBILITY AND TELLING THE
REALLY IMPACTFUL STORY OF HIV
RESEARCH IN THE FIELD OF
MEDICINE AT THAT EARLIER LEVEL?
THANKS.
>> ACTUALLY, THANK YOU VERY
MUCH, A GREAT ASKINGS.
I THINK WE CAN LOOK INTO THAT
FURTHER.
THERE'S ONE IDEA THAT WE HAD
STARTED TO GAIN SOME MOMENTUM ON
LAST YEAR WAS TO HAVE NIH HIV
RESEARCH PROGRAMS BECOME A
PRESENCE AT NON-HIV SETTINGS.
FOR EXAMPLE, THERE ARE LARGE
AGING CONFERENCES THAT HAVE
HAPPEN TWO OR THREE TIMES A
YEAR, VERY FEW HIV RESEARCHERS
ATTEND.
AND SOME OF THESE ARE VERY
INEXPENSIVE, TO HOST A BOOTH.
I THINK IF WE CAN DISPLAY THE
OPPORTUNITIES FOR AGING
RESEARCHERS TO COME TO HIV,
THAT'S ANOTHER WAY WE CAN BRING
WORKFORCE IN.
IN DIFFERENT PERSPECTIVES,
INNOVATIVE IDEAS.
>> THANKS SO MUCH.
>> ANY OTHER COMMENTS?
OR ISSUES?
I'LL ADD MY TWO CENTS FOR DR.
ALBERTI.
SOME CRITERIA TO EVALUATE IMPACT
OF THE INNOVATION YOU LISTED A
LOT OF OBVIOUS THINGS,
PUBLICATIONS, COLLABORATIONS.
BUT ONE OF THE THINGS I DIDN'T
SEE SPECIFICALLY STATED WAS IF
INTENDED TO BE KIND OF A
COLLABORATION IS THERE ANY KIND
OF METRIC WITHIN THE INTRAMURAL
THAT MEASURES THE OUTPUT
RELATIVE TO THESE, IS IT
PRIMARILY COLLABORATION?
FOR YOUNG PEOPLE K AWARDS,
ALLOWING THEM TO TRANSITION OUT
FROM NIH, IS ONE OF THE LISTED
FUNDING STREAMS I'M FAMILIAR
WITH, A LOT OF INTRAMURAL
TRAINEES LOOK FORWARD TO DOING.
SO IS THERE ANY OBJECTIVE WITHIN
THE INNOVATION TO KIND OF
MEASURE IMPACT BY TRANSITIONS OR
IS IT PRIMARILY THROUGH INTERNAL
COLLABORATIONS, OR BOTH?
>> THAT IS ACTUALLY A GREAT
IDEA.
WE HAVEN'T APPROACHED THE
COLLABORATION AND TRANSITION OUT
OF -- FOR THE YOUNG
INVESTIGATORS WHEN THEY
TRANSITION OUT OF THEIR JUNIOR
POSITION TO INDEPENDENT.
BUT THAT'S DEFINITELY AN ANGLE
THAT WE CAN EXPLORE FURTHER, TO
DOCUMENT THAT.
>> ALMOST SOUND LIKE WE DEAL
WITH THAT WITH CFARS, EVALUATING
IMPACT, DID THEY PUBLISH, WRITE
AN R21, TRANSITION TO FACULTY
APPOINTMENT?
IT SOUNDS LIKE YOU'RE KIND OF IN
SIMILAR LANE AS FAR AS --
>> YEAH.
>> IN THAT REGARD.
FOR I GUESS DR. CHANG MY ONLY
COMMENT WOULD BE IF YOUR
ADVERTISING BUDGET IS LIMIT TO
TRY TO ENCOURAGE PREVIOUS
ATTENDEES TO NETWORK FOR YOU.
THEY ARE YOUNG INVESTIGATORS,
THEY HAVE ACCESS TO SOCIAL MEDIA
PLATFORM.
IF YOU CAN EMPOWER THEM WITH
POSTS THAT THEY CAN MOVE WITHIN
THEIR SOCIAL NETWORKS AND SAY
YOU'VE BEEN TO ONE OF OUR
CONFERENCES, SO TELL A FRIEND, A
LOT OF EARLY PEOPLE KNOW OTHER
EARLY PEOPLE OR PEOPLE COMING
BEHIND THEM.
SO I WOULD TRY TO TAP YOUR
ALUMNI FOR SORT OF FURTHER
ADVERTISING YOUR PROGRAM.
>> YEAH, THANK YOU FOR THAT
SUGGESTION.
WE'RE ALSO TRYING TO TRACK THE
TRAJECTORIES OF OUR WORKSHOP
ATTENDEES TO SEE IF THEY ARE
SUCCESSFUL IN FUTURE YEARS IN
OBTAINING NIH FUNDING.
>> DR. FLETCHER?
>> THANKS.
THANKING BOTH PRESENTERS FOR THE
PRESENTATIONS, DR. CHANG, TO
YOUR LAST COMMENT ON YOUR SLIDE
ABOUT HOW TO PROMOTE, I EXPECT
THESE ARE ALREADY ON YOUR LIST
BUT I'LL MENTION THEM ANYWAY.
ONE I THINK UNIVERSITY RESEARCH
OFFICES, WHETHER THAT'S YOUR
VICE CHANCELLOR, VICE PRESIDENT,
VICE WHATEVER OF RESEARCH
SPONSORED PROGRAMS,
ADMINISTRATION, AND THE SECOND
THAT I THINK IS MISSED A LOT IS
UNIVERSITY'S BIOMEDICAL LIBRARY.
AT LEAST SEARCHING WITHIN THE
BIG TEN INSTITUTION WHERE IS WE
ARE BOTH OFFICES, EVEN BEFORE
THE CURRENT DISRUPTIONS, HAVE
UPPED THEIR GAME IN TERMS OF
BEING A RESOURCE FOR INFORMATION
FOR ALL INVESTIGATORS, BUT IN
PARTICULAR FOR EARLY CAREER,
EARLY STAGE INVESTIGATORS.
SO IF THEY ARE NOT ON YOUR RADAR
SCREEN I THINK PUMPING
INFORMATION TO UNIVERSITY
RESEARCH OFFICES AND THE
BIOMEDICAL LIBRARIES OF THOSE
UNIVERSITIES COULD BE TWO USEFUL
STRATEGIES FOR YOU.
>> GREAT.
THANK YOU FOR THOSE SUGGESTIONS
>> DR. GULICK?
>> THANKS, LUIS.
I THOUGHT I WOULD CHIME IN, DR.
CHANG, AND GIVE YOU THE
SUGGESTION OR QUESTION, HAVE YOU
TALKED TO THE HIV MEDICAL
ASSOCIATION AND IDSA SINCE THEY
SHARE THE GOAL OF NOT ONLY
TRYING TO INCREASE THE PIPELINE
GOING INTO INFECTIOUS DISEASE
BUT ALSO HIV?
AND THEY ARE VERY GOOD AT
COMMUNICATION.
THAT WOULD BE A NICE PARTNERSHIP
TO EXPLORE IF THAT'S A
POSSIBILITY.
>> THANK YOU.
THAT'S EXACTLY WHAT WE NEEDED TO
HEAR.
>> YES, DR. SANTA MARIA?
>> ONE OTHER SUGGESTION WOULD BE
TO BE ABLE TO DIVERSIFY ACROSS
DISCIPLINES AND PERHAPS WORK
WITH THE ASSOCIATION OF NURSES
AND AIDS CARE.
>> THANK YOU.
I THINK WE HAVE A PLAN
ENGAGEMENT WITH THEM TOO.
>> GREAT.
>> ANY OTHER COMMENTS?
>> WE MIGHT HAVE -- DR. DANEN
BERG WOULD LIKE TO SAY
SOMETHING.
>> ONE OF THE ISSUES WE STRUGGLE
WITH IS HOW TO EVALUATE THE
IMPACT OF LET'S SAY PROGRAMS
LIKE THIS AND WHAT ARE THE
METRICS OF SUCCESS?
AND THE TYPICAL ONES WE KNOW,
RIGHT?
PUBLICATIONS, GRANTS, MAYBE
GETTING A FACULTY POSITION.
I'D LOVE TO HEAR WHAT OTHER
METRICS YOU MIGHT PROPOSE AS
METRICS OF SUCCESS, COULD BE
TAKING A LEADERSHIP POSITION IN
A PUBLIC HEALTH DEPARTMENT,
COULD BE, YOU KNOW, I GUESS I
WOULD BE VERY INTERESTED TO HEAR
ANY SUGGESTIONS OF METRICS OF
SUCCESS THAT WE CAN TRACK.
>> I'LL ASK A CLARIFICATION
PROGRAM.
WHEN THE PROGRAM WAS INITIATED
WHAT WAS THE INTENDED PURPOSE?
IN OTHER WORDS, WHAT DID YOU
ENVISION THIS PROGRAM TO
ACCOMPLISH?
WAS IT TO GENERATE LEADERS IN
SCIENCE AND IMPACTFUL OR
INDEPENDENT INVESTIGATORS,
COLLABORATION, OR ALL OF THE
ABOVE?
>> ARE YOU ASKING REGARDING
INNOVATION PROGRAM OR ECI
PROGRAM?
>> REGARDING THE POINT HOW BEST
TO EVALUATE IT I THINK THE
INTENDED MISSION OF THE PROGRAM,
SOME EXTENT, WOULD GUIDE THAT
ANSWER.
ONE COULD WEIGH DIFFERENT
OUTCOMES DEPENDING WHAT THE
OBJECTIVE WAS, AND THAT'S WHY
I'M KIND OF ASKING CAN WE
RECONFIRM OBJECTIVES AND SAY,
WELL, BASED ON THAT THIS IS WHAT
WE WOULD SUGGEST, IF IT'S NOT
ALREADY THERE.
>> WELL, FOR THE INNOVATION
PROGRAM IT'S FAIRLY SIMPLE, HIGH
RISK, HIGH REWARD SEED PROJECTS.
WE WANT TO HAVE THESE IDEAS TO
FLOURISH AND GROW BIGGER THAN
WHEN THEY COME TO US.
THAT'S IN A VERY BIG PICTURE.
>> OKAY.
IT'S ABOUT THE RESEARCH
INNOVATION ITSELF, NOT ABOUT THE
CANDIDATES OR TRAJECTORY OF THE
CANDIDATES ITSELF, FOR EXAMPLE
THE OTHER PROGRAM IS MORE
TARGETED FOR THE EARLY
INVESTIGATORS.
THIS IS FOR THE SCIENCE AND THE
VALUE OF THE IMPACT OF THE
SCIENCE.
DR. SANTA MARIA?
ONE SUGGESTION FOR A METRIC,
WHETHER THAT INDIVIDUAL BECOMES
A FELLOW IN THEIR DISCIPLINE, IF
THEY GET INDUCTED INTO AN
ACADEMY, IF THEY GET A PECASE
AWARD BASED ON STRATEGIES IN
HIV, GET INTO HONOR SOCIETIES,
HALL OF FAMES FOR RESEARCHES, SO
FORTH.
>> THANKS YOU.
THAT'S REALLY HELPFUL.
>> AS YOU BECOME MORE MATURE IN
THE PROGRAM, IT ALMOST SOUNDS
LIKE IN JOURNALS WHEN THE
JOURNALS OFFER THE CUTTING EDGE
OF IMKNOWLEDGE, FOR EXAMPLE, OR
OTHER SUCH PREMIER COMPONENTS,
ONE WAY THAT THEY GET EVALUATED
IS TO WHAT EXTENT IS CITATION
RATE, WITHIN ONE YEAR, NOT
NECESSARILY IMPACT FACTOR BUT
IMMEDIACY OF ITS IMPACT IS ONE
POTENTIAL METRIC THAT IS USED TO
SEE IT CAME OUT TO A
PUBLICATION, DIDN'T MAKE AN
IMPACT WITHIN AN INTENDED GOAL,
THAT WOULD BE ONE POTENTIAL
METRIC YOU COULD POTENTIALLY
CONSIDER AS YOU MOVE THE PROGRAM
FORWARD.
THE OTHER IS TO WHAT EXTENT DID
THIS WORK SEED ADDITIONAL
PROPOSALS OR INITIATIVES WITHIN
THE PARENT GRANT OR THAT WAS
PICKED UP BY SOMEBODY ELSE THAT
WAS IN THE NETWORK.
IF YOU KIND OF DO -- IF YOU'RE
LOOKING FOR WHETHER IT TRULY
SEEDED SOMETHING NEW THEN OTHER
PEOPLE SHOULD BE WORKING ON THIS
SUBSEQUENTLY WITHIN THE SAME
DOMAIN.
BUT IT'S A HARDER METRIC BECAUSE
OBVIOUSLY WE ALL THINK WE'RE
DOING INNOVATION WITHIN OUR
LABS, SO TO COME BACK AND SAY
THAT YOU HAVE SOMETHING UNIQUE,
METRICS WOULD NEED TO WAIT IN
ORDER TO SEE THE IMPACT OF THAT
AS OPPOSED TO EARLY
INVESTIGATOR, I SUPPORTED AND
THEY TRANSITIONED WITHIN, YOU
KNOW, A YEAR OR TWO AS A HARD
METRIC AVAILABLE.
SO --
>> THANK YOU.
>> ANY OTHER COMMENTS OR
FEEDBACK?
>> I THINK IT'S A VERY
INTERESTING DISCUSSION BUT WE DO
NEED TO MOVE ON FOR THE SAKE OF
TIME.
>> PERFECT.
SO WE WILL MOVE TO THE ADVISORY
COUNCIL REPRESENTATIVES.
WE WILL GET AN UPDATE, NATIONAL
ADVISORY MENTAL HEALTH COUNCIL,
DR. DIANNE RAUSCH WILL PROVIDE A
SUMMARY.
>> THANKS FOR THE OPPORTUNITY TO
PRESENT TODAY.
I'M GOING TO -- SINCE GERI
INTRODUCED NEW LEADERSHIP I'LL
SKIP THIS AND GO TO AN
INITIATIVE THAT WE ACTUALLY
PRESENTED THIS AT THE SEPTEMBER
2024 OPEN COUNCIL.
WE NORMALLY -- PROGRAM NORMALLY
DOES PRESENT THEIR INITIATIVES
AT THE OARAC.
I'M THE ONLY ONE RIGHT NOW.
THIS IS THE FIRST OPPORTUNITY
I'VE HAD TO DO THIS AT OARAC
SINCE WE HAVEN'T HAD AN OPEN
MEETING IN A WHILE.
THIS INITIATIVE IS -- HOLD ON.
I'LL GET MY COMPUTER BACK UP.
ONE SECOND.
IT WENT TO SLEEP.
OKAY.
SO, THIS INITIATIVE IS
ADDRESSING AN ISSUE IN THE
NEURO-HIV AREA.
WE KNOW HIV ENTERS THE CNS EARLY
AFTER INFECTION, WITHIN MAYBE 8
DAYS.
AND THERE ARE COMPLICATIONS IN
THE CNS FROM HAVING HIV THERE.
OVER THE YEARS WE'VE SPENT
EFFORT TRYING TO UNDERSTAND WHAT
CAUSES OF THESE ARE AND THERE
ARE A NUMBER OF COMPLEXITIES AND
A NUMBER OF PATHOGENESISES, BUT
WE'VE DONE MULTIPLE CLINICAL
TRIALS AND NONE OF THEM HAVE
EVER REALLY HAD A POSITIVE
EFFECT.
ALTHOUGH ANTIRETROVIRALS
DECREASE SEVER ITY THERE'S A
NUMBER OF PROBLEMS THAT PEOPLE
LIVING WITH HIV LONG TERM HAVE.
MULTIPLE CLINICAL TRIALS THAT
WE'VE TRIED TO DO OVER THE YEARS
HAVE NOT IDENTIFIED ANY
PARTICULAR POSITIVE OUTCOMES.
SO, OVER THE YEARS 21-22 WE
CONVENED A NUMBER OF WORK
GROUPS, AND BROUGHT TOGETHER
WIDE RANGE OF EXPERTISE TO TRY
TO UNDERSTAND WHAT THE PROBLEMS
WERE AND WHY WE CAN'T SEEM TO
GET A BETTER UNDERSTANDING OF
HOW TO TREAT THESE
COMPLICATIONS.
A LOT OF THE REASONS FOR THAT
ARE LISTED HERE ON THE RIGHT.
PARTICULARLY THE HIV AND CNS AS
MULTI-FACTORIAL PROCESS.
SO ONE OF THE GOALS OF THIS HOW
WE MIGHT UNDERSTAND HOW WE MIGHT
BETTER ADDRESS THIS.
IF YOU -- WE DECIDED WE WOULD
TRY TO TAKE A COMPUTATIONAL
PSYCHIATRY APPROACH, AND DEVELOP
SOME PERSONAL MEDICINE IDEAS TO
ADDRESS THIS.
THERE'S A NUMBER OF DIFFERENT
OBVIOUSLY POTENTIAL CONTRIBUTORS
TO THE PATHOGENESIS, BUT WHAT
THE MECHANISMS AND HOW TO TARGET
THESE HAVE NOT BEEN WELL
UNDERSTOOD.
SO, THIS IS KIND OF AN OUTLINE
OF WHAT WE'RE LOOKING AT, SOME
OF THE REASONS THAT WE HAVEN'T
BEEN ABLE TO COME UP WITH A GOOD
CONCEPT FOR TREATING IT IS THAT
WE'VE FOCUSED MOSTLY ON GLOBAL
OUTCOMES THAT WERE BROAD, NOT
SPECIFICALLY TARGETED.
AND SO WE WANTED TO TRY TO LOOK
AT MORE WORKING MEMORY,
EXECUTIVE FUNCTION, DEPRESSION,
ANXIETY, TRY TO SEPARATE THESE
THINGS OUT SO WE COULD TARGET
INDIVIDUAL COMPONENTS,
INDIVIDUAL TOXICITIES, AND
INDIVIDUAL PATHOGENESIS.
AND SO ONE OF THE MAJOR PROBLEMS
THAT WE'VE HAD IS THAT WE
HAVEN'T HAD -- BEEN ABLE TO HAVE
A REALLY GOOD RECRUITMENT
CRITERIA BECAUSE PATIENTS WERE
DIVERSE.
AND THERE'S A LOT OF
COMORBIDITIES, INTERPERSONAL
FACTORS THAT COME INTO PLAY.
SO AT THESE MEETINGS THAT WE
HAD, WE BROUGHT TOGETHER SOME
DATA SCIENTISTS, WE HAVE A LOT
OF DATA THAT WE'VE COLLECTED
OVER THE YEARS.
AND THEY ARE TRYING TO USE DATA
SCIENCE AND MACHINE LEARNING TO
TRY TO SEPARATE OUT SOME OF THE
COMPONENTS THAT MIGHT BE
RESPONSIBLE FOR SOME OF THESE
CNS COMPLICATIONS AND MAYBE
SEPARATE THOSE OUT INTO
INDIVIDUAL TARGETS AND
INDIVIDUAL POTENTIAL APPROACHES.
SO, THE WAY WE'RE TRYING TO DO
THIS IS TO USE A BIPHASIC
APPROACH, TO IDENTIFY STUDIES,
DEVELOP STUDIES, THESE ARE THE
FIRST PART WOULD BE
DEVELOPMENTAL STUDIES THAT WOULD
TRY TO IDENTIFY SPECIFIC PATIENT
GROUPS WITH TREATABLE TRAITS,
FOLLOWED BY STUDIES OF TARGET
ENGAGEMENT.
THEN EVALUATE THESE FOR THE
EFFECTS OF THE SPECIFIC
RECRUITMENT, RETENTION, AND
ASSESSMENTS.
AND THEN EXAMINE THE IMPACT OF
THE TARGET MODIFICATIONS ON
NEUROTRANSMITTERS, BRAIN
CIRCUITS AND NETWORK THAT MIGHT
REGULATE MOOD, COGNITION AND
BEHAVIOR AND PILOTS THAT COULD
LEAD TO LARGER STUDIES TO
CONFIRM TARGET ENGAGEMENT AND
TEST EFFICACY OF THESE
STRATEGIES AND MOVE TO A LARGER
TRIAL SEE IF WE COULD ACTUALLY
IDENTIFY THESE ETIOLOGIES AND
TARGET SPECIFIC ONES.
SO, THE PURPOSE OF THIS IS TO
IDENTIFY MODIFIABLE TARGETS AND
EMPLOYEE PERSONALIZED MEDICINE
APPROACH TO ADDRESS TREATABLE
TRAITS TO DESIGN COMPREHENSIVE
AND VALIDATED TREATMENT
STRATEGIES, TO DEVELOP TREATMENT
STRATEGIES USING EXPERIMENTAL
THERAPEUTICS APPROACH,
THERAPEUTICS-BASED APPROACHES,
IDENTIFICATION OF MODIFIABLE OR
POTENTIAL MODIFIABLE TARGETS
THAT MIGHT TRANSLATE INTO
CLINICAL HYPOTHESES AND TEST
APPROACHES AND MONITOR OUTCOMES.
THE ULTIMATE GOAL IS TO ENHANCE
QUALITY OF LIFE, REDUCING
SYMPTOM SEVERITY, MAXIMIZING
ADEQUATE FUNCTIONING OF PEOPLE
WITH HIV EXPERIENCING SOME OF
THESE CNS COMPLICATIONS.
SO I'M HAPPY TO ANSWER QUESTIONS
IF THERE ARE ANY.
>> THANK YOU, WE'LL PROCEED INTO
THE QUESTIONS OR COMMENTS.
FIRST WE'LL START WITH THE ROOM.
DR. GLENSHAW, ANY COMMENTS FROM
THE ROOM?
>> NOT AT THIS TIME.
>> THANK YOU.
ANY COMMENTS ONLINE, OR
CLARIFICATIONS?
ALL RIGHT.
THANK YOU, EVERYONE.
THANK YOU, DR. RAUSCH, FOR THE
UPDATE.
WE'LL PROCEED AS WE BEGIN TO
CLOSE.
REMINDER, WE HAVE ALLOTTED TIME
FOR PUBLIC COMMENTS.
DR. GLENSHAW YOU HAVE COMMENTS
SO I'LL HAND OFF TO YOU.
>> THANK YOU.
YES, WE HAVE I BELIEVE 37 PUBLIC
COMMENTS.
THE FIRST THREE ARE REGARDING
HIV RESEARCH.
AND THE REST ARE REGARDING
GUIDELINES.
THE THIRD ONE IS A HYBRID.
WE'RE DOING OUR BEST TO BE
RESPONSIVE AND VOICE ALL OF
THESE COMMENTS, EVEN THOSE THAT
WERE RECEIVED DURING THE
MEETING.
SO PLEASE BEAR WITH ME IF I'M
STUMBLING A LITTLE BIT.
THE FIRST PUBLIC COMMENT FROM
LAUREN KLEIN FROM PHYLLIS FRANK
CENTER OF ROCKLAND COUNTY,
STATING CUTTING FUNDING FOR HIV
RESEARCH IS EXTREMELY SHORT
SIGHTED AND POLITICALLY
MOTIVATED.
THE WORLD IS ON THE BRINK OF
BEING ABLE TO PREVENT HIV VIA
VACCINE AND CURE THROUGH
GLOBALLY COORDINATED RESEARCH.
MULTIPLE CANDIDATE VACCINES MOVE
THROUGH THE PIPELINE EACH YEAR.
IT WILL TAKE ONLY ONE TO
SUCCEED.
EACH YEAR MORE PEOPLE ARE
FUNCTIONALLY CURED VIA STEM CELL
TRANSPLANT.
THESE TRANSPLANTS ARE ONLY
INDICATED FOR USE IN PEOPLE WITH
ADVANCED CANCERS, EACH CASE
TEACHES SCIENTISTS MORE ABOUT
THE BIOLOGICAL MECHANISMS AT
PLAY, GETTING CLOSER TO
FUNCTIONAL CURE FOR GENERAL
POPULATION.
PRETENDING NIH EXPECTS TO BE
SHIFTING FOCUS TOWARDS USING
CURRENTLY AVAILABLE APPROACHES
TO ELIMINATE HIV, MEANS NIH IS
CONTENT TO HAVE AMERICANS
CONTINUE TO CONTRACT HIV.
BECOME SICK AND DIE.
CURRENT APPROACHES TO PREVENT
HIV ARE NOT PERFECT.
THEY ARE MADE LESS EFFECTIVE
WHEN THE FEDERAL GOVERNMENT CUTS
FUNDING SUPPORT TO THEM.
IT IS ALSO MADE LESS EFFECTIVE
WHEN THERE'S A SUPREME COURT
CASE, BECAUSE IT, QUOTE,
PROMOTES HOMOSEXUAL BEHAVIOR.
THE NIH DOES NOT EXPECT THAT
CURRENTLY AVAILABLE APPROACHES
TO IN FACT -- WILL ELIMINATE
HIV/AIDS.
PERHAPS IT EXPECTS UNDESIRABLE
AMERICANS TO DIE OF AIDS.
THE DECISION TO CUT NIH FUNDING
IS SHORT SIGHTED, NOT POPULAR
WITH THE AMERICAN PEOPLE, NOR
ETHICAL NOR IN LINE WITH
CHRISTIAN VALUES.
>> NEXT JOHN MEADE, KENDALL
WRIGHT, THEY STATE TODAY WE
WRITE WITH DEEP CONCERN ABOUT
THE INFRASTRUCTURE AND CALL TO
ACTION FOR THIS BODY SAFEGUARD
VALUES OF EQUITY, EVIDENCE,
ACCOUNTABLE THAT MUST GUIDE OUR
WORK.
FY 26 PRESIDENT'S BUDGET
PROPOSED 36.4% CUT TO NIAID, AND
49% TO OAR, NOT JUST BUDGET LINE
ITEMS AND THESE REPRESENT
SIGNIFICANT SETBACK FOR
THOUSANDS OF RESEARCHERS,
PROVIDERS, MOST IMPORTANTLY
COMMUNITIES WHO RELY ON HIV, I'M
SORRY, ON NIH SUPPORTED SCIENCE
TO STAY ALIVE.
JEOPARDIZING U.S. STANDING AS A
SCIENTIFIC SUPERPOWER, PUBLICLY
FUNDED RESEARCH HAS BEEN A CORE
DIPLOMATIC STRATEGY, BY
IMPROVING LIVES OF MILLIONS
WORLDWIDE AND IN THE U.S. THAT
SUFFER FROM HEALTH CONDITIONS
LIKE HIV, TB, HEPATITIS, STI,
OTHER INFECTIOUS DISEASES.
THESE CUTS WOULD HALT PROMISING
RESEARCH ON LONG ACTING PrEP,
CURE STRATEGIES, COMORBID
CONDITIONS SUCH AS CANCER,
MENTAL HEALTH, SUBSTANCE ABUSE.
ALL OF WHICH IMPACT BROWN,
BLACK, LGBTQ COMMUNITIES HERE
AND ABROAD DISPROPORTIONATELY.
THEY THREATEN TO ERASE GAINS
ESPECIALLY AMONG POPULATIONS
HISTORICALLY EXCLUDED FROM
CLINICAL TRIALS.
THEIR PARTICIPATION AND
LEADERSHIP HAVE BEEN CRITICAL TO
INFORMING AND IMPLEMENTING NEXT
GENERATION OF PREVENTION AND
THERAPEUTICS TAILORED TO
COMMUNITY NEEDS, BRIDGING GAPS.
THEY STRESS THE IMPORTANCE OF
BIOMEDICAL INNOVATION AND
EQUITABLE IMPLEMENTATION.
THEY STATE WE NEED MORE FUNDING
FOR RESEARCH THAT EXAMINES HOW
TO BUILD TRUST, ADDRESS STIGMA,
OVERCOME BEARERS TO ACCESS.
THEY URGE THE OARAC TO PUBLICLY
OPPOSE THE PROPOSED CUTS IN FY
26 PROPOSAL AND DEFEND
COORDINATING ROLE ACROSS NIH.
ADVOCATE FOR AT LEAST
$3.9 BILLION FOR HIV DEFINED IN
THE PROFESSIONAL JUDGMENT
BUDGET.
REINFORCE IMPORTANCE OF
COMMUNITY-LED RESEARCH AND
INVESTMENTS IN IMPLEMENTATION
SCIENCE AND THOSE OUTLINED IN
THE RESEARCH AGENDA.
PUSH FOR TRANSPARENCY AND
ACCOUNTABILITY REGARDING HOW NIH
GRANT TERMINATIONS ARE HANDLED.
COMMUNITY ENGAGEMENT AND
SUSTAINED FEDERAL INVESTMENT
WILL DETERMINE WHETHER WE END
THE EPIDEMIC OR REGRESS.
SCALE UP ENTER INVESTIGATORS IS
REQUIRED FOR SUSTAINABILITY IN
THE EPIDEMIC AND BRING US CLOSER
TO AN END TO HIV EVERYWHERE.
NEXT IS LENGTHY SO I'LL SUMMIT
UP.
FROM RICHARD JEFFRIES, TREATMENT
ACTION GROUP.
HE STATES THE TO END REVERSAL F
GUIDELINES THAT SERVE IN KEEPING
CLINICIANS, CAREGIVERS, PEOPLE
WITH HIV AND ADVOCATES UP TO
DATE AS NEW INTERVENTIONS ARE
APPROVED AND/OR IMPORTANT NEW
DATA BECOME AVAILABLE.
THEY STATE THERE'S NO EVIDENCE
THAT ANY ANALYSIS WAS CONDUCTED
TO JUSTIFY DECISION TO END NIH
SUPPORT FOR THE GUIDELINES,
SUGGESTION ARE VAGUE AND
UNCONVINCING.
THEY DISCUSS THEIR OPPOSITION TO
GRANTS, AWARD TERMINATIONS,
REFERRING TO DISPROPORTIONATE
TERMINATIONS AFFECTING LGBTQ+
COMMUNITIES AND D.E.I.-RELATED
AWARDS.
THEY INCLUDE A STATEMENT THAT
HOMOGENEITY AND INACCESSIBILITY
ARE ANATHEMA TO NIH RESEARCH.
OARAC SHOULD QUESTION HOW
TERMINATION OCCURRED AND WHY
PROCEDURES WEREN'T FOLLOWED.
PAY ATTENTION TO THE PLIGHT OF
THE NETWORKS, NETWORKS HAVE BEEN
IMPACTED BY UNJUSTIFIABLE
DECISION TO PREVENT FUNDING TO
SOUTH AFRICA AND SUBSEQUENT
PAUSE ON FUNDING FOR ALL
INTERNATIONAL SUB-AWARDEES
INCLUDING CLINICAL TRIAL UNITS.
NIH HAS A LEGAL ONLY GAPINGS TO
ENSURE APPROPRIATE CARE AND
SAFETY MONITORING FOR TRIAL
PARTICIPANTS.
THESE NETWORKS WERE INTEGRAL TO
PrEP.
I'LL MOVE TO ABOUT 34 COMMENTS
REGARDING CLINICAL PRACTICE
GUIDELINES.
FIRST IS FROM SARAH MACBETH,
INFECTIOUS DISEASE PHYSICIAN AND
HIV SPECIALIST IN PITTSBURGH.
SHE FREQUENTLY USES GUIDELINES
AS IMPORTANT SOURCE OF
INFORMATION REGARDING NUANCES IN
CARING FOR PEOPLE WITH HIV.
SHE FINDS THEM ESPECIALLY
CRITICAL IN THE CARE OF PEOPLE
WITH INFREQUENTLY SEEN
OPPORTUNISTIC INFECTION INFECTA
TOOL FOR TEACHING, URGES TO
MAINTAIN ONLINE, ACCESSIBLE TO
ALL.
NEXT FROM DR. PHILIP BULLDOK WHO
HAS FOUR AFFILIATIONS, FAMILY
HEALTH CENTER OF THE WORCESTER,
MASS; UMass CHAN MEDICAL
SCHOOL; NEW ENGLAND AIDS
EDUCATION AND TRAINING CENTER;
VICE CHAIR OF HIV.
SOMEONE WHO SPENT A CAREER
PROMOTING HIV CARE AND PRIMARY
CARE SETTINGS, ALARMED BY THIS
WEEK'S ANNOUNCEMENT INDICATING
NIH'S DECISION TO STEP AWAY FROM
PRODUCING THE GUIDELINES.
THIS RESOURCE IS ABSOLUTELY
ESSENTIAL FOR PEOPLE LIKE MYSELF
ON THE GROUND DELIVERING CARE
AND EDUCATING COLLEAGUES,
TRAINEES, STUDENTS IN THE
STANDARDS OF HIV CARE.
ALONG WITH NATIONAL HIV
CURRICULUM, NATIONAL CLINICIAN
CONSULTATION CENTER, GUIDELINES
FORM A TRIFECTA ENSURING PEOPLE
WITH HIV RECEIVE APPROPRIATE BUT
COST EFFECTIVE CARE.
OARAC TO WORK ON FINDING
ALTERNATIVE DIVISION AND FUNDING
FOR CONTINUED PRODUCTION OF THE
GUIDELINES, PERHAPS WITHIN THE
HIV/AIDS BUREAU.
NOTES THAT ESPECIALLY WITH
PROPOSED CUTS TO PART F OF THE
RYAN WHITE PROGRAM WHICH COULD
ELIMINATE AIDS EDUCATION AND
TRAINING CENTERS, PRESERVATION
OF THREE KEY NATIONAL RESOURCES
IS ESSENTIAL.
THE NEXT IS FROM DR. LISA
KENSINGER, PROVIDER AT A NEW
YORK CITY HOSPITAL, REFERS TO
THE GUIDELINES ON A WEEKLY BASIS
TO TREAT PATIENTS, GUIDED HER IN
TREATING ILL PATIENTS, PREGNANT
WOMEN WITH HIV, AND TREATING AND
SHE IMPLORES OARAC TO KEEP THE
GUIDELINES.
NEXT FROM PETER McKELLAR,
STATES I'VE BEEN A TEACHER AND
CLINICIAN IN INTERNAL MEDICINE
AND INFECTIOUS DISEASES FOR 50
YEARS, FEDERAL HIV GUIDELINES
ARE ESSENTIAL TO TEACHING AND
PRACTICE OF HIV MEDICINE.
FOR OUR GOVERNMENT TO CURTAIL
PRODUCTION AND USE IS
UNCONSCIONABLE.
ASKS OARAC TO PROMPTLY
RECONSIDER THIS RECKLESS
DECISION.
AND RECONSIDER CONTINUANCE OF
THE GUIDELINES.
NEXT FROM DAVID BULLWARE, HIV
GUIDELINES ARE VALUABLE RESEARCH
FOR THE HIV COMMUNITY IN THE
U.S. AND GLOBALLY.
STATED RATIONALE FOR
DISCONTINUING GUIDANCE,
GUIDELINES, BASED ON FINANCES,
SEEMS REMARKABLE THAT VAST
MAJORITY OF GUIDELINES MEMBERS
ARE UNPAID VOLUNTEERS AND MEET
VIA ZOOM OR TEAMS.
VOLUNTEERS WRITE THE GUIDELINES.
INCREASED TRANSPARENCY WOULD BE
IDEAL TO SHARE
WHAT IS THE BUDGET FOR THE
GUIDELINES?
REEVALUATING THE COST WOULD BE
THE FIRST STEP INSTEAD OF ENDING
ALL SUPPORT.
THIS NEXT ONE FROM LYNN, A
FORMER NICHD LEADER AND OARAC
MEMBER, AND CURRENTLY WITH THE
GLASER PEDIATRIC AIDS
FOUNDATION, WAS CLAIRE -- CHAIR
OF GUIDELINES WHEN SHE WORKED AT
NIH.
THIS IS A LENGTHY COMMENT.
SIDE NOTE WE'LL BE SHARING ALL
OF THE COMMENTS IN THEIR FULL
FORM IN THE MINUTES OF THIS
MEETING.
SO I'M DOING MY BEST TO
SUMMARIZE LONGER ONES TODAY.
SHE GIVES A LONG HISTORY OF THE
GUIDELINES, ONE HIGHLIGHT TO
NOTE IS THAT THE INITIAL
GUIDANCE WAS RAPIDLY PUBLISHED
IN MMWR IN 1994, DETAILED
VERSION IN AUGUST OF 1994, AND
THESE WERE CRITICAL IN PROVIDING
GUIDANCE TO CLINICIANS CARING
FOR WOMEN WHO APPROVED AZT AND
COVERAGE OF AZT WHICH OCCURRED
IN DECEMBER OF THAT SAME YEAR.
WITHIN THREE YEARS OF THIS
DECISION THE U.S. HAD A 65%
REDUCTION IN NEW PERINATAL
INFECTION.
SHE GOES ON TO DISCUSS PEDIATRIC
GUIDELINES AND THAT THEY WERE
ESTABLISHED AS A SEPARATE PANEL
IN 1988.
ONE HIGHLIGHT SHE NOTES IS THAT
IN 1989, 50% OF CHILDREN WITH
HIV IN THE UNITED STATES DIED BY
AGE 2.
THANKS TO THE GUIDELINES, SOME
HAD CHILDREN OF THEIR OWN
WITHOUT HIV, PANELS INCLUDE
REPRESENTATIVES FROM CANADA AND
AUSTRALIA WHO ADAPT'S GUIDANCE
TO THEIR COUNTRIES.
SHE MENTIONS UNIQUE FACETS OF
THE GUIDELINES PANELS INCLUDE
MEMBERSHIP OF SPECIFIC EXPERTS
IN THE FIELD, MULTIPLE HHS
AGENCIES, REPRESENTATIVES FROM
OTHER COUNTRIES, AS WELL AS
COMMUNITY MEMBERS AFFECTED BY
HIV TO ENSURE THE GUIDELINES ARE
UNDERSTANDABLE, TO BOTH
COMMUNITY MEMBERS AND
CLINICIANS.
ALL OF WHOM DONATE TIME TO
PROVIDE THIS GUIDANCE.
SHE NOTES THAT HHS GOVERNANCE OF
THE GUIDANCE TO BE USED BY
PEDIATRIC AND OBSTETRIC
SPECIALTY ORGANIZATIONS AND FOR
REIMBURSEMENT THROUGH MEDICAID
AND HRSA.
NEXT COMMENT FROM SARAH BARES
FROM UNIVERSITY OF NEBRASKA
MEDICAL CENTER.
CONCERN ABOUT THE PHASEOUT, HAS
RELIED ON THE GUIDELINES TO
PROVIDE HIGH QUALITY
EVIDENCE-BASED CARE AND
POTENTIAL DISCONTINUATION
REPRESENTS SIGNIFICANT THREAT TO
PROVIDERS AND PATIENTS
NATIONWIDE.
GUIDELINES ARE THE GOLD STANDARD
IN THE U.S., AND ARE
DISTINGUISHED BY SCIENTIFIC
RIGOR, CLINICAL RELEVANCE,
TIMELY RESPONSIVENESS TO
EMERGING EVIDENCE.
FROM THE FIRST PROPHYLAXIS
RECOMMENDATIONS TO MOST RECENT
UPDATES, GUIDELINES ARE
CONSISTENT IN THEIR HIGH IMPACT
AND PRACTICAL GUIDANCE.
SHE NOTES THEY ARE COLLABORATIVE
AND MULTI-DISCIPLINE GLARE
PROCESSES LED BY EXPERT
VOLUNTEER PANELS, HIGHLY SKILLED
NIH STAFF.
UNMATCHED IN INTEGRITY AND
SCOPE.
MODEL HAS ENHANCED CREDIBILITY
AND CONTRIBUTED TO EQUITY AND
AND STANDARDIZED CARE
NATIONWIDE.
SHE NOTES THAT SUGGESTION OF
ANOTHER AGENCY WITHIN HHS MIGHT
ASSUME RESPONSIBILITY IS DEEPLY
CONCERNING.
OUR AGENCY HAS INFRASTRUCTURE,
EXPERTISE, ESTABLISHED PROCESS
TO MAINTAIN THE SAME LEVEL OF
QUALITY AND TIMELINESS.
WITHOUT CONTINUED NIH SUPPORT
SHE FEARS GUIDANCE WILL BECOME
STATIC, FRAGMENTS, AND
INACCESSIBLE.
ALL OF WHICH WOULD BE PROFOUNDLY
DETRIMENTAL TO PATIENT CARE.
SHE NOTES AT A TIME THAT WE'RE
STRIVING TO END THE HIV EPIDEMIC
IS NOT THE MOMENT TO WEAKEN A
TOOL.
URGES OAR AND NIH LEADERSHIP TO
RECONSIDER, CONTINUE PROVIDING
NECESSARY RESOURCES TO SUPPORT
ONGOING DEVELOPMENT AND
DISSEMINATION OF GUIDELINES.
DR. ANDREW TROTTER, UNIVERSITY
OF ILLINOIS COLLEGE OF MEDICINE.
HE NOTES THAT HIS COMMENTS ARE
HIS OWN, AS A PROVIDER,
EDUCATOR, MEMBER OF HIV M.A. AND
NOT HIS INSTITUTION.
HE'S AN HIV CLINICIAN WITH OVER
15 YEARS OF CLINICAL EXPERIENCE,
ASSOCIATE PROFESSOR, MEDICAL
DIRECTOR OF THE RYAN WHITE
PROGRAM AND STEERING COMMITTEE
MEMBER OF THE RYAN WHITE MEDICAL
PROVIDER COALITION.
HE STATES THE GUIDELINES ARE
CRITICAL RESOURCE FOR ANYONE
TAKING CARE OF PEOPLE WITH HIV
IN THE U.S.
PERSONALLY UTILIZES THEM AND
REFERS TO THEM ALMOST EVERY DAY.
THEY SERVE AS MOST COMPREHENSIVE
UP-TO-DATE EVIDENCE-BASED
GUIDANCE ON THE MANAGEMENT AND
TREATMENT OF HIV AND
OPPORTUNISTIC INFECTION AND
PERINATAL CARE, STANDARD OF CARE
FOR FINANCIAL AND INSURANCE
REIMBURSEMENT AND ENSURE HIV
WILL BE COVERED FOR COST OF --
COST OF CURE WILL BE
APPROPRIATELY COVERED.
AND THEY ARE ACCESSIBLE AT THE
POINT OF CARE.
HE UNDERSTANDS BUDGETARY
CONSTRAINTS BUT THEY MUST BE
MAINTAINED AS NATIONAL STANDARD
OF CARE FOR PEOPLE WITH HIV.
IF THEY NEED TO BE SHIFTED TO
ANOTHER AGENCY IN HHS, IT MUST
BE DONE IN A WAY GUIDELINE
REVIEW AND REVISION PROCESS AND
SUPPORT WILL BE MAINTAINED.
HE NOTES HIV CARE IS RAPIDLY
CHANGING, AND FEDERAL HIV
GUIDELINES ARE THE MOST
UP-TO-DATE RESOURCE WITH READILY
AVAILABLE UPDATES REGARDING THE
MOST RECENT SCIENTIFIC AND
CLINICAL DEVELOPMENT.
NEXT FROM DR. SUSANA QUICHEN.
I'M NOT CERTAIN OF HER
AFFILIATION BUT SHE NOTES SHE
WORKS IN UTAH.
SHE'S AN ADULT AND PEDIATRIC
I.D. PHYSICIAN WHO WORKS IN A
RELATIVELY LOW HIV INCIDENCE
STATE, UTAH.
THE GUIDELINES ARE THE MOST
IMPORTANT FOR HER FELLOW
COLLEAGUES AND FAMILY PRACTICE
PEDIATRICS AND INTERNAL MEDICINE
IN THE U.S.
SHE PROVIDES A LIST OF WHY THEY
SHOULD BE CONTINUED.
AS A RURAL STATE PERINATAL
GUIDELINES OFFER ON DEMAND
SUPPORT 24 HOURS A DAY FOR WOMEN
AND INFANTS AFFECTED BY HIV IN
THE INTERMOUNTAIN WEST, ONLY ONE
PEDIATRIC INFECTIOUS DISEASE
GROUP THAT SERVES ALL OF UTAH,
IDAHO, PARTS OF NEVADA, MONTANA,
WESTERN COLORADO.
NEARLY IMPOSSIBLE FOR US TO TAKE
CONSULTS AND BY PHONE AND
TELEMEDICINE BY PHONE FOR
INFANTS BORN TO A MOTHER WITH
HIV.
GUIDELINES HELP PHYSICIANS AND
PRACTITIONERS, THEY SERVE AS A
TOOL FOR MEDICAL STUDENTS,
RESIDENTS, FELLOWS.
WHICH ARE EVIDENCE-BASED AND
UPDATED REGULARLY.
HIV CHANGES WITH NEW MEDICATION
AND THOUSANDS OF STUDIES
PUBLISHED ANNUALLY.
GUIDELINES OFFER A PLACE NO
OTHER SOURCE CONSOLIDATES AND
REVIEWS PERTINENT INFORMATION.
PEOPLE LIVING WITH HIV HAVE
ACTIVE ROLE ON EACH GUIDELINE
COMMITTEE, ALLOW -- ONE OF THE
FEW CASE VOICES CAN BE HEARD FOR
A MORE PATIENT-CENTERED
APPROACH, IMPROVE OUTCOMES,
REDUCE MORBIDITY, MORTALITY,
GUIDELINES IDENTIFY AREAS OF
RESEARCH THAT NEED
INVESTIGATION, THUS DRIVING
INNOVATION AND DIAGNOSIS,
TREATMENT, PREVENTION.
THEY ARE THE SOURCE THAT GUIDE
INSURANCE COVERAGE IN A TIMELY
MANNER AND ARE RESPECTED AND
THEIR VALIDITY IS UNMATCHED BY
ANY OTHER SOURCE.
NEXT FROM DR. KIRK FETTERS,
UNIVERSITY OF COLORADO.
HE DISAPPROVES OF THE PLAN TO
REMOVE SUPPORT FROM THE
GUIDELINES.
THEY ARE ESSENTIAL RESOURCES FOR
BOTH PHYSICIANS AND PATIENTS.
SORRY.
THEY ARE INVALUABLE FOR
TREATMENT OF HIV AND SEQUELAE OF
HIV IN UNCOMMON SCENARIOS AND
MANY CLINICIANS INCLUDING I.D.
SPECIALISTS MAY NOT HAVE MUCH
EXPERIENCE IN TREATING.
HARD WORK PUT INTO THESE
GUIDELINES BY MANY CLINICIANS
OVER THE YEARS HAVE IMPROVED AND
STANDARDIZED HIV CARE AROUND THE
COUNTRY.
HE NOTES ALTERNATIVE GUIDELINES
EXIST BUT ARE NOT TAILORED TO
LIVED REALITY IN THE U.S.
DOES NOT SUPPORT TRANSITIONING
TO ANOTHER AGENCY.
OAR DEVELOPED RELATIONSHIPS AND
EXPERTISE UNMATCHED IN THE REST
OF HHS.
PROPOSED CHANGES COMES IN THE
CONTEXT OF UNPRECEDENTED REMOVAL
OF THE CDC STI GUIDELINES,
NATIONAL HIV DATASETS, CURRENT
ACI TEAM MEMBERS PLUS VACCINE
SKEPTICISM AT FDA, CANCELLATION
OF RESEARCH GRANTS CREATING THE
APPEARANCE NO LONGER SUPPORTING,
THIS WOULD BE A SHORT-SIGHTED
POLICY GOAL THAT WOULD RESULT IN
MANY MORE PEOPLE DYING OF
PREVENTIBLE OR TREATABLE
DISEASES.
NEXT IS FROM DR. TERRY CHRISTINE
PHILLIPS AND COLLEAGUES FROM
PEDIATRIC INFECTIOUS DISEASES
SOCIETY.
THEY ARE WRITING TO EXPRESS
CONCERN ABOUT NIH DECISION TO
PHASE OUT SUPPORT OF THE
CLINICAL PRACTICE GUIDELINES,
PROFESSIONAL SOCIETY REPRESENTS
PEDIATRIC I.D. SPECIALISTS AND
RESEARCHERS, MANY ARE INVOLVED
WITH DIRECT PATIENT CARE,
INFANTS, CHILDREN, ADOLESCENTS
WITH HIV OR AT RISK OF HIV.
URGES OARAC TO RECONSIDER AND
ADVOCATE FOR FEDERAL LEADERSHIP
IN DEVELOPMENT AND DISSEMINATION
OF GUIDELINES.
SHE SAYS GUIDELINES ARE
FOUNDATIONAL TO DELIVERY OF HIGH
QUALITY EVIDENCE-BASED CARE FOR
OVER ONE MILLION PEOPLE LIVING
WITH HIV IN THE U.S., PROVIDE
CRITICAL INFORMATION FOR
CLINICIANS, OF ALL POPULATIONS,
AND THAT PEDIATRIC GUIDELINES
ARE ESPECIALLY VITAL AS THEY
ADDRESS UNIQUE CHALLENGES SUCH
AS EARLY INFANT DIAGNOSIS AND
TREATMENT, PREVENTION OF
PERINATAL TRANSITION.
STATES A FEW STATISTICS WHICH I
WON'T READ AT THIS MOMENT.
SHE NOTES THE GUIDELINES ARE A
LIVING DOCUMENT WITH UPDATES,
THEY ARE RESPONSIVE, HAVE A
LEVEL OF RESPONSIVENESS JOURNALS
CAN'T MATCH, ENSURE PATIENTS
RECEIVE CARE INFORMED BY BEST
PRACTICES AND SHAPE INSURANCE
COVERAGE DECISIONS AND DIRECTLY
ALLOW ACCESS TO LIFESAVING
DIAGNOSTICS TREATMENT,
PREVENTION SERVICES.
THEIR LOSS WOULD CREATE
UNCERTAINTY, POTENTIALLY LEADING
TO FRAGMENTED CARE AND
DISPARITIES, URGE MAINTENANCE OF
SUPPORT UNDER THE STEWARDSHIP OF
A BODY WITH EXPERTISE RATHER
THAN DISCARDING DECADE OF
FEDERAL INVESTMENT NIH SHOULD
COLLABORATE TO PRIORITIZE KEY
ELEMENTS, STREAMLINE PROCESSES,
REDUCE COST.
PUBLIC INPUT FROM GUIDELINES
USERS AND BROADER HIV COMMUNITY
SHOULD ALSO BE SOLICITED.
SUSTAINING THEM IS CRITICAL AMID
ONGOING WORKFORCE SHORTAGES AND
EROSION OF PUBLIC HEALTH
INFRASTRUCTURE.
PEDIATRIC I.D. SOCIETY IS READY
TO COLLABORATE TO SAFEGUARD THE
HEALTH AND WELL-BEING OF
CHILDREN AND ADOLESCENTS
AFFECTED BY HIV.
NEXT IS FROM PETER SALBERG, HOPE
THAT NIH WILL RECONSIDER ANY
THOUGHT THEY SHOULD NOT BE A TOP
FUNDING PRIORITY UNDER NIH
SPECIFIC HIGH-QUALITY
SUPERVISION.
AS A CLINICIAN IN RURAL NEW
HAMPSHIRE HE CANNOT UNDERSTATE
HOW MUCH GUIDELINES PROVIDE KEY
ROLE IN DISSEMINATING BEST
PRACTICES IN THE COUNTRY TO
CLINICIANS IN BIG POPULATION
CENTERS.
HE STATES MORE AND MORE WE RELY
ON INEXPERIENCED WORKFORCE,
THERE'S NO SUBSTITUTE FOR CLEAR
EVIDENCE-BASED SUPER PRACTICAL
STRATEGIES THAT THE GUIDELINES
HAVE ALWAYS OFFERED.
THE NOTION THE GUIDELINES ARE IN
FACT COST EFFECTIVE AND BEST USE
OF LIMITED TAXPAYER DOLLARS
RATHER THAN SOMETHING THE
COUNTRY CAN AFFORD TO
DEPRIORITIZE.
NEXT IS FROM SARAH WEIBEL,
CONCERNING ABOUT REPORTED
DECISION TO CUT GUIDELINES.
DECISION IS NOT ONLY SHORT
SIGHTED, IT'S COUNTERPRODUCTIVE
TO PUBLIC HEALTH.
PANEL HAS BEEN A CORNERSTONE IN
ENSURING CLINICIANS, RESEARCHERS
AND STAKEHOLDERS HAVE ACCESS TO
CLEAR EVIDENCE-BASED AND
UP-TO-DATE TREATMENT GUIDELINES
FOR CARE.
THEY ARE CONSULTED BY THOUSANDS
OF PRACTITIONERS AND
INSTITUTIONS AND ARE REGARDED
GLOBALLY AS GOLD STANDARD.
WHAT MAKES THE DECISION EVEN
MORE DIFFICULT TO UNDERSTAND IS
THAT PANEL MEMBERS MOSTLY SEARCH
VOLUNTARILY, DONATING TIME AND
EXPERTISE WITHOUT COMPENSATION.
TO ELIMINATE SUCH A HIGH IMPACT
LOW COST INITIATIVE SEND THE
WRONG MESSAGE AT A TIME WHEN
CONSISTENCY, CLARITY, AND TRUST
IN PUBLIC HEALTH LEADERSHIP ARE
MORE VITAL THAN EVER AND WILL
CREATE CONFUSION, WIDEN GAPS IN
CARE AND UNDERMINE DECADES OF
TREATMENT.
URGES OARAC TO REAFFIRM THE
FEDERAL GOVERNMENT'S COMMITMENT
TO THE GUIDELINES.
NEXT IS FROM A FORMER OARAC
MEMBER, LINDA DEAN, AIDS ACTION
BALTIMORE, DISAPPOINTED THAT THE
DISCUSSION SCHEDULED FOR TODAY'S
PUBLIC SESSION WAS REMOVED,
ESSENTIALLY REMOVED FROM THE
AGENDA AND RESPECTFULLY URGES
NIH TO ENSURE DECISIONS ARE MADE
IN A PUBLIC AND TRANSPARENT
MANNER WITH FOR INPUT FROM THE
COMMUNITY PARTICULARLY
INDIVIDUALS WHOSE LIVES ARE
IMPACTED BY THEIR AVAILABILITY.
SHE STRONGLY URGES NIH NOT TO
ABANDON SUPPORT FOR THE
GUIDELINES THAT SET THE STANDARD
OF CARE FOR THREE DECADES.
NOTES THE GUIDELINES HAVE
IMPROVED LIVES OF COUNTLESS
PEOPLE THROUGH INCLUSIVE AND
COMMUNITY-DRIVEN PROCESS AND
THAT THEY ARE THE MODEL FOR
GUIDELINES DEVELOPMENT AND
COMMUNITY ENGAGEMENT.
SHE STATES SHE RECOGNIZES NIH IS
NOT IN THE BUSINESS OF
GUIDELINES INVESTMENT AND
INSTITUTIONS TOOK A BOLD AND
LIFE SAVING STEP TO DEVELOP
GUIDELINES TO ENSURE RAPID
ADVANCES IN THE FIELD, REACHING
THOSE WHO NEED THEM, NOT BEING
PRESENTED AT CONFERENCES OR
JOURNAL, PEOPLE LIVING WITH HIV
OUTSIDE OF AREAS WITH I.D.
EXPERTISE WHICH ARE MANY CAN
BENEFIT FROM THE HIGHLY
EFFECTIVE TREATMENT DEVELOPED
WITH SUPPORT FROM THE NIH.
GUIDELINES HELP AND CONTINUE TO
HELP TO ERODE STIGMA IN
ACCESSING TREATMENT DUE TO
PROVIDER RESISTANCE AND
INSECURITY.
SHE SAYS THIS DECISION COULD NOT
BE MORE ILL TIMED AND FEARS IT
IS PART OF A BROADER STRATEGY TO
ABANDON COMMUNITY AND COUNTRY'S
EFFORTS TO END THE HIV EPIDEMIC.
SHE NOTES PUBLIC HEALTH PROGRAMS
AND PEOPLE WITH HIV AND
PROVIDERS ARE ALL UNDER ATTACK.
LOSS OF THE EXPERT UNBIASED
GUIDELINES SET THE GOLD
STANDARD, A MAJOR BLOW, PUTTING
LIVES AT RISK, URGES NIH TO
RECONSIDER THIS DECISION AND
INSTEAD WORK WITH THE WORKING
GROUP LEADERS AND COMMUNITY TO
DEVELOP A STRATEGY FOR REDUCING
BUDGETARY COSTS AND MAINTAINING
THEM, GUIDELINES, WITHOUT
COMPROMISING ACCESSIBILITY,
TIMELINESS, SCIENTIFIC RIGOR.
NEXT FROM DR. PABLO TEVS,
UNIVERSITY OF PENNSYLVANIA, HE
SAYS FOR MORE THAN 25 YEARS
GUIDELINES HAVE BEEN A RESOURCE
OFFERING TIMELY EVIDENCE-BASED
AND PRACTICAL RECOMMENDATIONS
THAT HAVE DIRECTLY IMPROVED
CLINICAL OUTCOMES FOR PEOPLE
WITH HIV, SERVED AS MODEL FOR
TRANSLATING CLINICAL RESEARCH
INTO MEANINGFUL IMPACT .
THESE GUIDELINES HAVE
CONSISTENTLY ENABLED RAPID
ADOPTION OF MORE EFFECTIVE AND
LESS TOXIC REGIMENS, CLINICAL
EXPERTISE AND CONSENSUS RATHER
THAN BUREAUCRATIC INERTIA.
FREQUENT UPDATES, RESPONSIVENESS
AND GUIDANCE DISTINGUISHED THEM
FROM TRADITIONAL SOCIETY
GUIDELINES OFTEN LESS NIMBLE AND
MORE CONSUMED BY PROCESS THAN
UTILITY.
HE NOTES LEADERSHIP OF DOCTORS
CLIFF LANE AND ALICE PAU HAVE
ENSURED INTEGRITY, RIGOR, AND
INDEPENDENCE OF THE EFFORT.
GUIDELINES ARE TRANSPARENT,
CONFLICT OF INTEREST MANAGED,
MOST IMPORTANTLY THEY ARE
INDEPENDENT FROM INDUSTRY
INFLUENCE, A FEATURE THAT HAS
GIVEN THEM UNMATCHED
CREDIBILITY.
THEY ARE A MODEL FOR HIV
TREATMENT POLICY WORLDWIDE,
REFERENCED WIDELY, ADAPTED
INTERNATIONALLY.
MODEST INVESTMENT REQUIRED TO
SUSTAIN THEM IS NEGLIGIBLE
COMPARED TO LIVES SAVED.
HE URGES OARAC AND NIH
LEADERSHIP TO PRESERVE
GUIDELINES PROGRAM IN CURRENT
FORM AND CONTINUE TO SUPPORT AS
A VITAL PUBLIC HEALTH TOOL.
NEXT FROM CADEN ANDREWS, I DON'T
HAVE AN AFFILIATION FOR THIS
PERSON.
THEY ARE A PHYSICIAN CARING FOR
PEOPLE WITH HIV IN DALLAS,
TEXAS, USES THE GUIDELINES AT
LEAST ONCE A WEEK, TO HELP WITH
CHALLENGING CASES.
THEY HAVE COME TO TRUST THEM, AS
AUTHORITATIVE SOURCE OF
INFORMATION GIVEN RIGOROUS
VETTING OF SCIENCE AND CAREFULLY
SELECTED MEMBERS OF THE PANEL.
THEY ARE DISTRESSED TO LEARN OF
THE PLAN TO PHASE OUT
GUIDELINES, HARD TO IMAGINE
ANOTHER BODY BEING ABLE TO TAKE
ON THIS EFFORT IN A SIMILARLY
EFFECTIVE WAY.
GUIDELINES FROM PROFESSIONAL
ORGANIZATIONS LIKE IDSA ARE
UPDATED EVERY FIVE YEARS, MAJOR
PROBLEM TO STAY CURRENT, URGE
LEADERSHIP TO RECONSIDER AND
CONTINUE THE PANELS IN CURRENT
FORM.
NEXT THOMAS MARTIN FROM UC-SAN
DIEGO, SAN DIEGO V.A., CONCERN
AS A PROVIDER, ASTONISHED THIS
INVALUABLE COMMITTEE COULD BE
DISBANDED, THOUSANDS OF
PROVIDERS LIKE THEMSELVES IN THE
U.S. AND AROUND THE WORLD DEPEND
ON THE GUIDANCE, AND UP-TO-DATE
RECOMMENDATIONS FOR OPTIMAL
TREATMENT OF HIV.
TO BELIEVE INDIVIDUAL PROVIDERS
WOULD HAVE TIME REVIEW
LITERATURE, MAKE COMPLEX
EFFICACY ANALYSES AND EVALUATE
COMPLEX DRUG-DRUG INTERACTIONS
INCLUDING PHARMACOKINETIC
EVALUATION IS RIDICULOUS AND
DANGEROUS.
IF WE HAVE INTEREST IN IMPROVING
COST EFFECTIVENESS THEY WOULD BE
MORE THAN HAPPY TO DISCUSS THIS
AND LIKELY MILLIONS AND MILLIONS
IN HEALTHCARE SAVINGS THAT
DON'T -- THAT COULD BE MADE THAT
DON'T REQUIRE THOUGHTLESS
CUTTING OF UNVOLUNTEER
ACADEMICS.
NEXT FRANCESCA TORIANA, UC-SAN
DIEGO, DEEP CONCERN OVER THE
REPORTED DECISION TO CUT THE
PANEL.
THIS DECISION IS TROUBLING, GOES
AGAINST CORE PRINCIPLES, DOES
NOT SUPPORT IMPROVEMENT AND
EDUCATION OF PROFESSION,
COUNTERPRODUCTIVE TO PUBLIC
HEALTH.
HAS BEEN A CORNERSTONE ENSURING
CLINICIANS, RESEARCHERS, AND
STAKEHOLDERS ACROSS THE U.S. AND
BEYOND HAVE ACCESS TO CLEAR
EVIDENCE-BASED AND UP-TO-DATE
TREATMENT GUIDELINES FOR HIV
CARE.
THEY ARE CONSULTED BY THOUSANDS
OF PRACTITIONERS AND
INSTITUTION, REGARDED GLOBALLY
AS GOLD STANDARD.
NOTES MEMBERS ARE VOLUNTEER, AND
TO ELIMINATE HIGH IMPACT LOW
COST INITIATIVE WOULD SEND THE
WRONG MESSAGE AT A TIME WHEN
CONSISTENTLY CLARITY ARE MORE
VITAL THAN EVER.
SHE'S CONCERNED THIS DECISION
COULD CREATE CONFUSION IN
CLINICAL PRACTICE AND URGES
OARAC TO RECONSIDER THIS
DECISION.
NEXT FROM WILLIAM CONNORS FROM
UNIVERSITY OF BRITISH COLUMBIA,
ST. PAUL'S HOSPITAL.
EXPRESSING DEEP CONCERN AS AN
HIV PROVIDER, EDUCATOR,
ROUTINELY USES THE GUIDELINES TO
INFORM CARE AND EDUCATE STUDENTS
AND COLLEAGUES.
COULD THINK OF NO OTHER CLINICAL
RESOURCE THAT HE HOLDS IN SUCH
HIGH REGARD, BELIEVES ANY
DISRUPTION IN THE UPDATING
PROCESS AND LOSS OF HIGH
EVIDENCE-BASED STANDARDS AND
EXCEPTIONAL QUALITY WILL BE AT
AN A COST.
THIS IS FROM JOSE MIRA,
UNIVERSITY OF BARCELONA.
INTERNATIONAL MEMBER OF THE
EXPERT PANEL FOR MORE THAN 20
YEARS, I WANT TO LET YOU KNOW
THE GUIDELINES ARE A GLOBAL
BENCH MARK, PERFECTLY UP THE
DATE HELPING PHYSICIANS AROUND
THE WORLD TREAT HIV INFECTED
PATIENT WITH O.I.
THEY ARE SAVING LIVES.
EDUCATION AND HEALTH CARE WORK
IS INVALUABLE AND STRONGLY
BELIEVES ROLE SHOULD NOT BE
CHANGED IN THE FUTURE, IF
ANYTHING SHOULD BE STRENGTHENED.
THIS IS FROM ELIZABETH LAIDLAW,
PHYSICIAN ASSISTANT, WORKING AT
THE NIH IN INFECTIOUS DISEASE
CLINICAL RESEARCH.
VOICING SUPPORT FOR THE NEED TO
CONTINUE THE FEDERAL GUIDELINES,
REFERENCES FREQUENTLY TO PROVIDE
BEST MEDICAL CARE, KNOWS THEY
ARE RELIABLE, UP TO DATE, CAN BE
REFERENCED QUICKLY, OR READ IN
DEPTH AS NEEDED.
SHE'S REFERRED MANY P.A. AND
MEDICAL STUDENT TO THEM OVER THE
YEARS AS THEY ARE EDUCATIONAL
AND PRACTICAL SOURCE OF
INFORMATION TO MANAGE MEDICAL
CARE FOR PEOPLE WITH HIV.
THIS IS FROM DR. BRIAN EPPLIN
FROM NIAID, BOTH A PROVIDER AND
RESEARCH AT NIH HAS TURNED TO
THE GUIDELINES COUNTLESS TIMES,
IMMENSE SOURCE OF INFORMATION,
SYNTHESIS OF A VAST FIELD OF
RESEARCH.
FURTHERMORE THEY IDENTIFY GAPS
IN KNOWLEDGE, FURTHER RESEARCH
IS NEEDED.
THIS IS AN INVALUABLE WAY TO
GENERATE IDEAS AND DISCUSSION.
IN AN ENVIRONMENT WHERE THE CARE
OF PEOPLE WITH HIV WORLDWIDE HAS
BEEN CURTAILED AND HIV RESEARCH
COME UNDER THREAT, SHOULD BE
OAR'S DUTY TO BE AN ADVOCATE.
WOULD BE SENDING A MESSAGE TO
THE ENTIRE HIV COMMUNITY IT DOTS
NOT -- DOES NOT CONSIDER THE
INFORMATION GENERATED WORTH
ADVANCING.
WE'RE GETTING THERE.
THIS IS FROM AARON READY,
CANADIAN NETWORK.
EXPRESSING DEEP CONCERN.
HER ORGANIZATION IS A NATIONAL
NETWORK OF PHARMACISTS ACROSS
CANADA, THAT WAS FORMED IN 1997,
COLLABORATING ON CLINICAL
PRACTICE, RESEARCH, EDUCATION,
AND MEMBERS RELY HEAVILY ON THE
HHS HIV GUIDELINES AS TRUSTED
EVIDENCE-BASED RESOURCE
INFORMING CLINICAL DECISIONS AND
CONSISTENCY IN CARE IN
HEALTHCARE SETTINGS.
NOTES THEY ARE A LONGTIME GOLD
STANDARD OFFERING TIMELY
RIGOROUSLY REVIEWED AND
ACCESSIBLE RECOMMENDATIONS
INVALUABLE TO CLINICIANS
WORLDWIDE.
DEEPLY CONCERNED ABOUT
DISCONTINUING NIH SUPPORT, WOULD
JEOPARDIZE QUALITY, CREDIBILITY,
ACCESSIBILITY OF GUIDELINES,
PROPOSED TRANSFER OF
RESPONSIBILITY TO ANOTHER AGENY
RAISES QUESTIONS ABOUT
PRESERVATION OF HIGH STANDARD.
LOSS OF NIH STEWARDSHIP WOULD BE
SIGNIFICANT SETBACK FOR
CLINICIANS AND PATIENTS, THEY
URGE NIH AND OAR TO RECONSIDER
THIS DECISION.
AND RECOGNIZE IRREPLACEABLE
VALUE OF THE GUIDELINES.
AND NIH SUPPORT SPECIFICALLY IS
ESSENTIAL TO MAINTAIN INTEGRITY
AND UTILITY OF THIS RESOURCE.
THIS IS FROM SCOTT BURTONI,
HEALTH HIV.ORG.
THERE'S A GROWING DISQUIET HOW
THIS WOULD BE MANAGED AND MAY
SIGNAL MORE BROADLY.
DEDICATED SESSION, HE'S GOT SOME
CONCERNS ABOUT TODAY'S AGENDA.
AND NOT JUST TECHNICAL DOCUMENTS
BUT ANCHORING, PRESCRIBING
PRACTICES, SHAPING POLICIES, IN
RYAN WHITE AND MEDICAID.
IN THE CURRENT CLIMATE SHIFTING
OVERSIGHT RAISES QUESTIONS FOR
THE FELD AND QUESTIONS WHETHER
GUIDELINES SCOPE, FREQUENCY OF
UPDATES AND LANGUAGE
PARTICULARLY AS RELATES TO
BLACK, BROWN, TRANSGENDER AND
DISPROPORTIONATELY AFFECTED
POPULATIONS WILL REMAIN
PROTECTED.
HE LOOKS FORWARD TO OARAC
AFFIRMING COMMITMENT TO THE
GUIDELINES, OUTLINING HOW
STAKEHOLDER VOICES WILL BE
MEANINGFULLY INCLUDED IN ANY
TRANSITION.
THIS IS FROM IDSA.
AUTHORED BY ANDREA WETEL, TINA
TAN, COLLEEN KELLY.
IT'S VERY LENGTHILY, I'LL SUM
UP.
MAIN PREMISE TO ENCOURAGE --
URGE NIH TO RECONSIDER THE
DECISION TO DISCONTINUE SUPPORT,
GIVEN IMMENSE VALUE TO HIV
CLINICAL CARE AND CRITICAL ROLE
IN PROMOTING A RESPONSE TO THE
EPIDEMIC IN THE U.S.
THEY URGE ALL DISCUSSIONS
REGARDING THE FUTURE TO THE
TRANSPARENT SO THE COMMUNITY,
PEDIATRICIANS, AND PEOPLE WITH
HIV WHO COUNT ON GUIDELINES CAN
FOLLOW AND INFORM THE PROCESS.
THEY MAKE SEVERAL POINTS WHICH
WE'LL PUBLISH WITH OUR MINUTES
REGARDING IMPLEMENTATION
SCIENCE.
REGARDING HEALTH OUTCOME AND
COST IMPACT.
INCREASED DEMAND FOR GUIDELINES,
UNIQUE NIH ROLE IN THE
GUIDELINES.
AND HOW THE GUIDELINES COULD BE
EVOLVED IN THE FUTURE.
CHRISTINE JOHNAJON, PHARMACIST,
NO AFFILIATION, KEEP THE
GUIDELINES, THEY PROVIDE THE
BEST UP-TO-DATE CARE, 30 YEARS
OF HER CAREER TAKING CARE OF
THESE PATIENTS THEY HAVE RELIED
HEAVILY ON THEM.
SPECIFICALLY REGARDING NEXT
GENERATION OF PHARMACISTS.
NEXT FROM DR. ALLISON ROCKSBY,
UNIVERSITY OF WASHINGTON,
GUIDELINES ARE INVALUABLE,
REFERENCES THEM ALL THE TIME,
HOPE THEY CAN CONTINUE AS
TRUSTED SOURCE OF INFORMATION.
THERE'S NO OTHER EASILY
ACCESSIBLE RESOURCE FOR THIS
PURPOSE.
FROM THE AMERICAN COLLEGE OF
CLINICAL PHARMACY RESEARCH
NETWORK.
EXPRESSES PROFOUND CONCERN AND
THAT THEIR ORGANIZATION IS
COMPRISED OF PHARMACISTS FROM
THE U.S., CANADA, SAUDI ARABIA.
THEY RELY EXTENSIVELY ON THE
GUIDELINES AS TO PROVIDE
EVIDENCE-BASED CARE AND
RECOMMENDATIONS THAT PROMOTE
CONSISTENT AND LIFE SAVING CARE,
TO ALL IN NEED.
PLANNED DISCONTINUATION OF NIH
SUPPORT THREATENS THE INTEGRITY,
RELIABILITY, AVAILABILITY OF THE
VITAL RESOURCE, PARTICULARLY
CONCERNED ABOUT THE IMPLICATIONS
OF TRAPS FERG RESPONSIBILITY
WITHOUT A CLEAR AND TRANSPARENT
PLAN, TO RESEARCH STANDARDS,
SUCH A MOVE RISKS UNDERMINING
DECADES OF PROGRESS THAT COULD
HINDER EFFORTS TO END THE HIV
EPIDEMIC.
THEY URGE NIH AND OAR TO
REEVALUATE AND REVERSE AND STATE
CONTINUED SUPPORT IS ESSENTIAL
TO SAFEGUARD INTEGRITY,
AUTHORITY, GLOBAL UTILITY OF THE
GUIDELINES, IRREPLACEABLE
CORNERSTONE OF HIV CLINICAL
PRACTICE.
I ALREADY READ THAT.
THERE'S FOUR LEFT.
THIS IS FROM BRIGHAM AND WOMEN'S
HOSPITAL.
WRITING TO EXPRESS STRONG
FEELING ABOUT THE GUIDELINES AND
ALL THEIR FORMS THEY SHOULD BE
MAINTAINED AND SUPPORTED BY
FEDERAL GOVERNMENT, THE SINGLE
MOST IMPORTANT SOURCE OF
CLINICAL INFORMATION WE USE AT
THE POINT OF CARE, MISSION
CRITICAL AND A WORTHY GOVERNMENT
FUNCTION THAT CONTRIBUTES TO
MAKING AMERICA GREAT.
THEY DEFINE CARE FOR THE WORLD.
WE'RE LEADERS IN THIS SPACE AND
PROVIDE VALUE.
MAKE AMERICA GREAT AND KEEP
THESE GUIDELINES.
THIS IS FROM NICOLA DEE, RETIRED
P.A. FROM NIH.
SHE STATES THAT TAKING CARE OF
PATIENTS WITH HIV RELIES ON THE
EXPANSIVE GUIDELINES AS A
ROADMAP TO PROVIDE CORRECT
ARVs, RECOMMENDATION REGARDING
TRANSMISSION AND TREATING
O.I.s, REFER TO THE GUIDELINES
ON A REGULAR BASIS, MADE BY
DEDICATED PANELS OF EXPERTS WHO
CREATE DOCUMENTS AFTER INTENSE
FOCUS AND ATTENTION TO DETAIL
AND DISCUSSION TO REACH
CONSENSUS.
NEXT FROM JENNIFER JANEL,
GAINESVILLE FLORIDA, DOCTOR
JANELLE, HIV PROVIDER AND
EDUCATOR, LOCAL MEDICAL SCHOOL,
REGIONALLY THROUGH FEDERALLY
FUNDED TRAINING CENTER.
USES GUIDELINES NEARLY DAILY IN
CARE AND TEACHING, BELIEVES LOSS
WILL RESULT IN SIGNIFICANT
REDUCTION IN PEOPLE PROVIDING
OPTIMAL CARE, QUICKLY MAKING
CARE DECISIONS IN REAL TIME.
THESE DECISIONS CAN MEAN THE
DIFFERENCE BETWEEN LIFE AND
DEATH.
NOTE THERE HAVE BEEN EFFORTS TO
EXPAND HIV WORKFORCE OUTSIDE OF
I.D. PROVIDERS, PRIMARY CARE
PROVIDERS WILLING TO CARE FOR
PATIENTS IN UNDERSERVED PARTS OF
OUR NATION BECAUSE THEY DON'T
HAVE TO FILTER THROUGH NUMEROUS
PAPERS BUT CAN RELY ON CAREFULLY
VETTED STUDIES WITH OUTCOMES
SUMMARIZED IN THE GUIDELINES.
SHE BELIEVES WITHOUT THE
GUIDELINES WE WILL LOSE
PROVIDERS WHO LACK FOCUS HIV
EXPERTISE BUT WILLING TO PROVIDE
CARE WITH THE SUPPORT OF THE
GUIDELINES.
COMBINED WITH PROPOSED CHANGES
AND SUBSTANTIAL CUTS TO PART F
OF RYAN WHITE TO DEVELOP --
SORRY.
DEVELOP AND DISSEMINATE RESEARCH
AND EDUCATION TO ORGANIZATIONS
AND PROVIDERS, THESE LOSSES WILL
RESULT IN LOSS OF KNOWLEDGE AND
EXPERTISE, AND WILL SET BACK
PROGRESS WE'VE MADE IN ENDING
THE EPIDEMIC IN THE U.S.
PROVIDERS WILL LIKELY RELY ON
BIASED INFORMATION FROM THE
PHARMACEUTICAL INDUSTRY WITHOUT
THE GUIDELINES THAT MAY NOT BE
IN THE BEST INTEREST OF PUBLIC
HEALTH, HEALTH OF INDIVIDUALS,
FINANCIAL HEALTH OF OUR
HEALTHCARE SYSTEM.
PLEASE MAKE STEPS TO ENSURE
ONGOING SUPPORT OF GUIDELINES
AND SO THEY CAN CONTINUE TO BE
LIVING DOCUMENT MADE BY UNBIASED
EXPERTS.
AND THE LAST IS FROM EILEEN
SCULLY, DR. EILEEN SCULLY,
EXPRESSING CONCERN, PROVIDER
FORE20 YEARS, MEMBER OF THE
PANEL FOR THREE YEARS,
GUIDELINES ARE DEFINITIVE OF THE
PUBLIC SERVICE THAT HHS SHOULD
BE SUPPORTING.
NOTES VOLUME OF DATA REVIEWED
AND SYNTHESIZED IS IMMENSE AND
RESOURCE FOR BOTH QUICK DECISION
MAKING AND DEEPER CONSIDERATION
OF EVIDENCE-BASED WHEN UNUSUAL
CASES ARISE.
CLEAR PUBLIC SERVICE THAT CANNOT
BE REPLACED.
RECONSIDER THIS DECISION AND
TAKE A CLOSER LOOK AT THE
INCREDIBLE LEVEL OF EFFICIENCY,
SCOPE OF VOLUNTARY TIME AND
EFFORT OF EXPERTS IN THE FIELD.
CONFIDENT YOU'LL CONTINUE TO
SUPPORT THIS PUBLIC GOOD WHICH
HAS DIRECT BENEFITS TO THE
AMERICAN PEOPLE.
THAT'S THE LAST ONE, DR.
MONTANER.
I THINK YOU'RE ON MUTE, DR.
MONTANER.
>> THANK YOU.
DO YOU HAVE ANY FINAL COMMENTS
BEFORE WE CLOSE, DR. DONENBERG?
>> I WANT TO THANK EVERYONE FOR
SUBMITTING THE COMMENTS AND
MAKING VERY CLEAR HOW IMPORTANT
THE CLINICAL PRACTICE GUIDELINES
ARE FOR CARE AND TREATMENT AND
EDUCATION.
THANK YOU.
>> THANK YOU.
THANK YOU VERY MUCH.
THANK YOU, EVERYONE, FOR JOINING
THIS MEETING.
TODAY'S MEETING IS NOW
ADJOURNED.
[END OF PROGRAM]