WELCOME, EVERYONE.
THIS IS THE AIDS RESEARCH
ADVISORY COMMITTEE.
MEETING.
THANK YOU FOR ALL ATTENDING,
INCLUDING THOSE OF YOU ONLINE.
I'M ELAINE ABRAMS, THE CHAIR.
AND WE'RE GOING TO START WITH
APPROVAL OF THE MINUTES FROM THE
JUNE 3RD MEETING.
WHICH YOU SHOULD HAVE REVIEWED
ONLINE.
ANYONE HAVE ANY QUESTIONS OR
COMMENTS ABOUT THE MINUTES?
IF NOT, CAN I SEE A MOVE FOR
APPROVAL?
SECOND?
ALL IN FAVOR?
GREAT.
SO NOW WE CAN GO ON TO THE
IMPORTANT PART, AND THE
DIRECTOR'S REPORT.
>> THANK YOU, ELAINE.
WELCOME, EVERYONE.
IT'S A PLEASURE TO BE HERE WITH
YOU TODAY.
I'D LIKE TO START BY THANKING
THE MEMBERS OF THE COMMITTEE WHO
ARE ROTATING OFF.
REUBEN, IT'S BEEN GREAT HAVING
YOU ON THE COMMITTEE AND WE
THANK YOU FOR YOUR SERVICE.
WE HAVE A -- YOU'VE GOT IT.
THAT'S GREAT.
ADDITIONALLY, KEITH, WHO
RECEIVED HIS PLAQUE FOR BEING A
COUNCILMEMBER FROM JEANIEN
PREVIOUS MEETING, THANK YOU FOR
YOUR SERVICE.
IT'S BEEN REALLY IMPORTANT TO
HAVE THE TWO OF YOU ON THIS
COMMITTEE THROUGH THIS PEER.
PERIOD.
THE SCIENCE THAT WE HAVE BEEN
DEALING WITH HAS BEEN
CHALLENGING, AND YOU DEFINITELY
HELPED US MOVE IT FORWARD.
I'D LIKE TO THANK THIS MOMENT TO
WELCOME CESAR BOGGIANO AS THE
NEW DIRECTOR OF THE VACCINE
RESEARCH PROGRAM.
CESAR HAS OVER 25 YEARS OF
EXPERIENCE IN DRUG DISCOVERY,
VACCINE KE SIGN AND EVALUATION
OF VACCINE CANDIDATES THROUGH
BOTH PRE-CLINICAL AND CLINICAL
STAGES.
CESAR HAD SERVED AS CHIEF OF THE
RP'S PRE-CLINICAL BRANCH SINCE
2020.
PRIOR TO THAT, HE HAD DEDICATED
MORE THAN SEVEN YEARS OF SERVICE
AS A PROGRAM OFFICER IN THE
VACCINE CLINICAL BRANCH.
CESAR HAS A PROVEN TRACK RECORD
OF SUCCESSFULLY LEADING AND
BUILDING DIVERSE
MULTIDISCIPLINARY RESEARCH
PROJECTS, FOCUSED ON HIV/AIDS,
TB AND COVID PREVENTION
STRATEGIES.
HIS COLLABORATIVE EFFORTS SPAN
PARTNERSHIPS WITH NATIONAL AND
INTERNATIONAL ACADEMIC
INSTITUTIONS, BIOTECH, AND
PHARMA.
WE'RE CONFIDENT THAT UNDER HIS
LEADERSHIP, VRP WILL CONTINUE TO
THRIVE AND MAKE SIGNIFICANT
ADVANCES IN THE FIELD.
NO PRESSURE, CESAR.
I WOULD ALSO LIKE TO TAKE A
MOMENT TO DEEPLY THANK JIM LANE
FOR HIS LEADERSHIP AS THE ACTING
DIRECTOR OF VRP.
JIM DID AN OUTSTANDING JOB IN
EXCEL RAACCELERATING THE SCIENCP
AND ALSO HELPING TO GUIDE US
THROUGH SOME VERY CHALLENGING
TIMES OVER THE LAST YEAR.
SO THANK YOU, JIM.
A DEAR FRIEND IS NOW RETIRING AT
THE END OF THE MONTH.
HE WAS RETIRING AFTER NEARLY 20
YEARS AT NIAID.
SO HE STARTED AS A CONTRACTOR AS
THE DIVISION -- AND HE WAS A
CONTRACTOR FOR ABOUT SIX MONTHS
WHILE THEY GOT HIS PAPERWORK
FINISHED.
BUT HE STARTED AT THAT TIME AS
WE WERE IN A VERY DIFFICULT TIME
IN DAIDS WHERE WE HAD RUN A
NETWORK RENEWAL, AND EVERYBODY
WAS UP IN ARMS.
WE HAD MADE SOME DRASTIC CHANGES
INTO THE SITES WE WERE GOING TO
SUPPORT, BASED ON PERFORMANCE,
WHICH WAS A NEW CONCEPT AT THAT
TIME.
WE HAD A SERIES OF SITES THAT
HAD NOT ENROLLED ANYBODY FOR TWO
OR THREE YEARS, AND THEIR
ATTITUDE WAS, I NEVER HAD TO
HAVE ANY SORT OF METRIC BEFORE,
WHY ARE YOU HOLDING ME TO THAT
NOW?
AND WE SPENT TIME IN SENATORS'
OFFICES AND VISITED THE HILL,
AND IT ALL WORKED OUT, BUT
THROUGH THAT, WE FORMED A VERY
STRONG BOND.
THE OTHER PERSON WHO WAS PART OF
THAT WAS JILL HARPER, WHO IS NOW
THE HEAD OF ESSENTIALLY THE
EXECUTIVE OFFICE OF THE
INSTITUTE.
AT THAT TIME SHE WAS OUR LEG
PERSON.
SO HE HAS REALLY PROVIDED
LEADERSHIP THAT WE IN DAIDS
DEEPLY APPRECIATED.
HE'SLED NIAID THROUGH
IMPLEMENTATION AND PLANNING
ACTIVITIES AND HELPED TO REALLY
BUILD STRATEGIC VISION FOR THE
INSTITUTE.
HIS DIFFERENT ROLES AS DEPUTY
AND THEN AS ACTING DIRECTOR, HE
HAS OVERSEEN THIS EXTENSIVE
PORTFOLIO AND HELPED US AS AN
INSTITUTE GROW FOR BIO-D,
HIV/AIDS, INFECTIOUS DISEASES
AND IMMUNE MEDIATED DISORDERS.
THERE'S A PROCESS INTERNAL
CALLED THE RIC THAT HE HAS
CHAIRED FOR YEARS, AND IT HAS
REALLY HELPED TO BRING THE
DIVISIONS TOGETHER AND FOSTER
COLLABORATION.
IN HIS OWN GENTLE WAY, HE LEADS
WITH HUMOR, HUMILITY, AND
OCCASIONALLY HE PUTS HIS FOOT OR
HIS KNEE IN YOUR BACK AND PUSHES
REALLY HARD.
SO HE KNOWS WHEN TO EXERCISE
THAT LEVEL OF INFLUENCE.
HE WILL BE MISSED.
I'D ALSO LIKE TO ANNOUNCE THAT
GERI DONENBERG HAS BEEN
ANNOUNCED BY MONICA BERTAGNOLLI
AS THE NEW DIRECTOR OF THE
OFFICE OF AIDS RESEARCH.
SHE WILL JOIN HIV IN OCTOBER AND
LEAD IN THE ADVANCEMENT AND
COORDINATION OF AIDS RESEARCH AT
NIH.
WE LOOK FORWARD TO WORKING WITH
HER.
DR. DONENBERG EARNED HER B. YOU.
AND PSYCHOLOGY AND POLITICAL
SCIENCE AT ANN ARBOR AND HER
PH.D. MASTERS AND PH.D. IN
PSYCHOLOGY AT UCLA.
SHE COMPLETED A PSYCHOLOGY
INTERNSHIP AT UCLA, AND ACTUALLY
DID A FULBRIGHT, WHICH IS AN
INTERESTING -- YOU DON'T SEE
THOSE VERY OFTEN IN THE
SCIENCES.
SCIENCES, IN CAPETOWN.
DR. DONENBERG HAS BEEN ACTIVE IN
REVIEW FOR NIH AND HAS OVER 170
PUBLICATIONS.
DR. DONENBERG BRINGS OVER 25
YEARS OF AIDS RESEARCH
EXPERIENCE FOCUSING ON THE
UNDERLYING MECHANISMS OF RISKY
SEXUAL BEHAVIOR AND SUBSTANCE
USE IN YOUTH, AND DESIGNING
SPECIALLY TARGETED INTERVENTIONS
TO PREVENT HIV PREVENTION.
SO SHE'S GOING TO BRING A NEW
ENERGY TO AIDS RESEARCH HERE AT
NIH AND THE INSTITUTE LOOKS
FORWARD TO WORKING WITH HER VERY
CLOSELY.
NOW TO THE BEST NEWS OF ALL, THE
BUDGET UPDATE.
THAT WAS SARCASM.
SO TO DATE FOR THE 2025
APPROPRIATIONS, THE PRESIDENT
RELEASED HIS BUDGET ON
MARCH 11TH.
THE HOUSE RELEASED THEIR VERSION
IN JULY.
AND THE SENATE JUST RELEASED
THEIR VERSION AT THE BEGINNING
OF AUGUST.
SO THIS GRAPHIC SHOWS THE
CURVES, AND NOTE FOR 2025 HOUSE,
THERE'S TWO NUMBERS, WITH
BASICALLY CUTTING THE INSTITUTE
IN HALF.
IT SEPARATES THE INFECTIOUS
DISEASE COMPONENT FROM THE
IMMUNOLOGY COMPONENT.
THE QUESTION WAS ASKED IN THE
PREVIOUS SESSION, THE OPEN
SESSION OF COUNCIL, WHAT WAS THE
LOGIC BEHIND THAT?
ANAND YOU SEE THE SENATE PROPOSD
A LITTLE BIT MORE MONEY FOR US
OVERALL.
SO WHAT WE'RE LOOKING AT, IF YOU
INTEGRATE THIS IN, IS NIAID IS
OVERALL SCHEDULED ON THE HOUSE
SIDE TO RECEIVE A VERY SMALL
INCREASE, AND ON THE SENATE SIDE
SHOULD IT BE ENACTED ABOUT A 2%
INCREASE AS OPPOSED TO WHAT THE
PRESIDENT PROPOSED IN HIS BUDGET
WAS NO REAL INCREASE OR A VERY
SMALL INCREASE FOR NIAID.
SUFFICE IT TO SAY, YOU MAY HAVE
NOTICED THERE'S AN ELECTION WITH
CAMPAIGNS GOING ON RIGHT NOW.
THERE'S A VERY GOOD CHANCE THAT
WE WILL BE UNDER A CONTINUING
RESOLUTION UNTIL JANUARY.
AT WHICH POINT, WHOEVER IS THE
PARTY IN CONTROL OF THE HOUSE
AND THE SENATE WILL DETERMINE
WHAT THIS ALL LOOKS LIKE.
SO WE'LL START THE YEAR UNDER A
CONTINUING RESOLUTION.
THIS WILL REQUIRE THAT BETWEEN
SOMETIME IN THE NEXT 21 DAYS,
THERE IS A CR PASSED BY THE
HOUSE AND SENATE TO KEEP US
OPEN.
I DON'T THINK THERE'S ANY DANGER
OF THEM NOT DOING THAT BECAUSE
IT WOULD LOOK BAD FOR THE PARTY
THAT LED TO THAT KIND OF A
SHUTDOWN OR POTENTIAL SHUTDOWN.
BUT THAT MEANS, AS YOU SAW, NRM
PAYLINES ARE QUITE DRACONIAN.
WE'RE AT 8 AND 10% FOR NEW -- 8%
FOR NEW -- REGULAR GRANTS.
10% FOR ESIs, SO THOSE NUMBERS
WILL CHANGE HOPEFULLY IF AND
WHEN WE GET A BUDGET.
SO IN TERMS OF SCIENCE AND
PROGRAMMATIC UPDATES, THIS WAS A
REALLY INTERESTING ONE THAT CAME
OUT IN JUNE.
AND THAT IS THAT THE
CCR5 INHIBITOR ACTUALLY HAS
ADDITIONAL ACTIVITIES, AND IN A
CLINICAL TRIAL, I DWES GUESS WL
IT -- THE BRAND NAME OF THE
DRUG -- WHEN GIVEN TO PEOPLE
WHO'VE UNDERGONE KIDNEY
TRANSPLANTS, IT IMPROVED
FUNCTION AND ACTUALLY THEY
EXPERIENCED LOWER RATES OF
REJECTION COMPARED TO PLACEBO.
AND PART OF THE PROBLEM, LIKE
WITH ALL OF THESE, IT WASN'T
STATISTICALLY SIGNIFICANT
BECAUSE THE CARE YOU RECEIVE IN
A TRIAL TENDS TO BE BETTER THAN
IN A -- WHEN THEY LOOKED AT
REJECTION RATES ACROSS THE
ENTIRE POPULATION.
SUFFICE IT TO SAY IT DIDN'T DO
HARM AND MAY DO SOME GOOD.
BUT THE IDEA THAT BLOCKING
CCR5 AS AN INNATE RESPONSE
COMPONENT RELATIVE TO
INFLAMMATION THAT'S ASSOCIATED
WITH REJECTION MAY BE IMPORTANT.
,
I THINK WAS AN INTERESTING
FINDING.
WE HAVE MADE AS A DIVISION AND
AN INSTITUTE TREMENDOUS PROGRESS
WITH INJECTABLE CABOTEGRAVIR.
NOT ONLY DOES IT PREVENT AN
ACQUISITION IN MEN AND WOMEN,
BUT IT ALSO IS LOOKING SAFE IN
PREGNANCY, AND NOW THE IDEA IS,
CAN WE EXTEND THIS INTO
PREGNANCY TO A POINT WHERE IT
BECOMES A MEANS OF PREVENTING
ACQUISITION DURING THE --
THROUGHOUT PREGNANCY AND THROUGH
THE BREASTFEEDING PERIOD.
AS WE GO FORWARD, AND WORK UP
CABROPIVARINE, CAN WE USE THAT
PAIR OF DRUGS IN PREGNANT WOMEN
OR PREGNANT PEOPLE THROUGH THE
BREASTFEEDING PERIOD TO HELP
PREVENT ACQUISITION.
SO THERE'S SO MUCH THAT WE CAN
DO WITH THESE NOW THAT I THINK
WILL BE EXCITING AND WE'LL GET
TO THAT DISCUSSION WHEN I TALK
LATER IN THE AFTERNOON ABOUT
FUTURE DIRECTIONS IN THE
NETWORKS, THIS IDEA THAT WE CAN
TAKE THESE NEW AGENTS AND USE
THEM THROUGH AN INTEGRATED SET
OF IMPLEMENTATION SCIENCE
EXPERIMENTS AS WELL AS CLINICAL
RESEARCH TO REALLY HELP US BUILD
A PACKAGE TO HELP TO PREVENT
VERTICAL TRANSMISSION.
SO THIS IS A VERY EXCITING TIME.
AND ALSO THIS IS NOW THE ONE
THAT'S APPROVED, WE STILL HAVE
ANOTHER TRIAL TO COMPLETE FOR
LEN, SO STAY TUNED, FOR NOW RAVI
WILL CONTINUE TO RIDE THIS
HORSE, RIGHT?
YOU'LL HEAR MORE ABOUT THE NIAID
STRATEGIC PLAN LATER THIS
AFTERNOON.
WE'VE BEEN WORKING ON THIS FOR I
GUESS SIX OR EIGHT MONTHS AT
THIS POINT.
ONE OF THE CRITICAL AREAS THAT
IS HELPING TO FEED INTO THE
STRATEGIC PLAN IS STAKEHOLDER
INPUT.
WE HAD AN RFI THAT WENT OUT AND
WE WERE THRILLED BY THE RESPONSE
NUMBERS AND THE QUALITY THAT WE
RECEIVED FROM THE COMMUNITIES
INVESTIGATORS, THROUGH
COMMUNITY, AND INTERESTED
FACULTY AROUND THE COUNTRY.
THAT'S THE REASON NICHOLAS
BESHUR IS ON THE AGENDA TODAY TO
TALK ABOUT THE OUTPUT OF THAT
RFI SO YOU CAN HEAR SOME OF THE
DETAILS AS PART OF OUR PROCESS
AS A DIVISION OF HAVING INPUT
INTO THE INSTITUTE'S STRATEGIC
PLAN.
ADDITIONALLY, ANNE IS HERE FROM
THE OAR TO GIVE A REPORT ABOUT
THE UPDATE OF THE MOST RECENT
OAR MEETING, THE MAJOR AREA OF
THAT, MAJOR TOPIC OF THAT
MEETING WAS THE OAR STRATEGIC
PLAN.
SO I THINK IN THIS RELATIVELY
SHORT PERIOD TODAY, YOU CAN HEAR
FROM ANNE AND NICK SOME ASPECT
OF THE PLANNING PROCESSES FOR
HIV/AIDS THAT ARE GOING ON AT
THE NIH, SO I THINK THAT WILL BE
VERY USEFUL.
SO I'LL CLOSE BY POINTING OUT
THAT THE NEXT MEETING WILL BE
JANUARY 27TH, 2025.
ALWAYS IN THE FUTURE, THE
MEETINGS IN THE DEAD OF WINTER
WILL BE VIRTUAL.
WE'VE HAD -- BEFORE THE
PANDEMIC, WHENEVER WE HAD A
MEETING IN JANUARY, IT SEEMED
LIKE THERE WAS ALWAYS TWO FEET
OF SNOW ON THE GROUND, AND IT
WAS ALWAYS TOUCH AND GO, SO JUST
EASIER TO MAKE THEM VIRTUAL.
SO WITH THAT, I WILL CLOSE, AND
HAPPY TO TAKE QUESTIONS.
SEEING NONE, WE CAN MOVE ON TO
OUR --
>> ARE THERE ANY QUESTIONS
ONLINE?
OKAY, GREAT.
THANK YOU VERY MUCH.
WE'RE GOING TO TURN NEXT TO THE
ONE CONCEPT THAT WE HAVE, BOB
MAHON.
I'M GOING TO ASK ALL VOTING
MEMBERS TO PLEASE OPEN UP YOUR
ELECTRONIC VOTING SO THAT YOU
CAN VOTE IMMEDIATELY AFTER THE
PRESENTATION.
AND WE'LL HAVE THAT DONE.
OKAY.
OVER TO YOU.
>> SO MY NAME IS ROBERT MAHON.
I WILL BE PRESENTING THIS
CONCEPT FOR APPROVAL ENTITLED
TRANSLATIONAL APPROACHES TO
DEVELOPING NEW TB MENINGITIS, OR
TBM DRUG REGIMENS IN PEOPLE
LIVING WITH AND WITHOUT HIV.
THE OBJECTIVE OF THIS PROPOSED
INITIATIVE WOULD BE TO ADVANCE
RESEARCH TO DEVELOP NOVEL
TREATMENT STRATEGIES THAT
ADDRESS TBM-SPECIFIC NEEDS AS
WELL AS TO ENSURE RECENT
SUCCESSES IN PULMONARY TB
TREATMENT ARE APPROPRIATELY
ADAPTED TO ADVANCE TBM TREATMENT
IN PEOPLE LIVING WITH AND
WITHOUT HIV.
WE'VE PROPOSED THIS AS A
COOPERATIVE AGREEMENT UNDER THE
ACTIVITY CODE OF U19.
PARTICIPATING NUMBER OF
GRANTABLECATIONS TO BE TWO TO
THREE AND THE ABILITY TO MAKE
ONE AWARD AND FINANCIALLY
COMMITTED PARTNERS FROM NINDS
AND NIMH.
SO TB IN GENERAL USING THE MOST
UP TO DATE STATISTICS FROM THE
WORLD HEALTH ORGANIZATION,
THERE'S APPROXIMATELY
10.6 MILLION NEW CASES OF TB
EVERY YEAR, WITH OVER 400,000 OF
THOSE BEING DRUG RESISTANT AND
THERE'S APPROXIMATELY
1.3 MILLION PEOPLE WHO DIE OF
TB.
SO NOW AS WE'RE FURTHER AWAY
FROM THE PART OF THE COVID
PANDEMIC, TB IS ONCE AGAIN
BECOMING THE MOST DEADLY
INFECTIOUS DISEASE IN THE WORLD.
FOR THOSE LIVING WITH HIV,
THEY'RE 18 TIMES MORE LIKELY TO
DEVELOP ACTIVE TB, AND TB IS A
LEADING CAUSE OF DEATH IN PEOPLE
LIVING WITH HIV.
SO TB MENINGITIS OCCURS WHEN TB
DISSEMINATES FROM THE LUNG,
CROSSES THE BLOOD BRAIN BARRIER
AND ESTABLISHES AN INFECTION IN
THE BRAIN AND CNS.
IT'S BELIEVED THAT UP TO .3 TO
5% OF ALL PEOPLE LIVING WITH TB
HAVE TBM, WHICH ROUGHLY ABOUT 30
OF THE 10.6 MILLION NEW CASES
EVERY YEAR, 30,000 TO 490,000 OF
THEM HAVE TBM.
AND FOR CHILDREN AND PEOPLE
LIVING WITH HIV, THERE ARE HIGH
RATES OF MORTALITY.
CHILDREN HAVE UP TO 20% OF THE
MORTALITY RATE FOR PEOPLE LIVING
WITH HIV, IT'S UP TO 40 TO 50%,
SO IT'S A VERY SIGNIFICANT
DISEASE AND DEADLY DISEASE FOR
BOTH POPULATIONS.
AND SURVIVORS HAVE THE RISK OF
SIGNIFICANT LONG-TERM
NEUROLOGICAL DISABILITIES, WHICH
CAN INCLUDE COMA, CRANIAL NERVE
DEFICITS, HEMI AND PARAPRECYST,
MOVEMENT DISORDERS AND VISUAL
AND HEARING DISTURBANCES.
AND WHILE THE MIGRATION OR THE
DISSEMINATION OF TB INTO THE
BRAIN IS A PRIMARY FACTOR IN
DEVELOPING TB MENINGITIS, IT'S
REALLY THE ABERRANT HOST IMMUNE
RESPONSE INDUCED IN THE BRAIN IN
C NS THAT DRIVES THE PATHOLOGY
THAT'S SEEN WITH TB MENINGITIS.
SO THE OVERALL DRUG PIPELINE FOR
TB IS QUITE ROBUST.
WE HAVE MULTIPLE NOW DRUGS BEING
IN CLINICAL DEVELOPMENT IN
VARIOUS PHASES OF CLINICAL
DEVELOPMENT WITH SEVERAL MORE
BEHIND THEM IN PRE-CLINICAL
DEVELOPMENT AND DISCOVERY.
BUT THE BULK OF THESE DRUGS AND
THE REGIMENS THAT ARE BEING
TESTED WITH THEM ARE BEING
STUDIED IN THE CONTEXT OF
PULMONARY TB.
WHEREAS TB MENINGITIS HAS
TREATMENT REQUIREMENTS THAT ARE
DISTINCT FROM PULMONARY TB, MOST
PREVALENT BEING THAT YOU NEED
SUFFICIENT CNS PENETRATION TO
ACHIEVE MTB KILLING IN THE BRAIN
AND CNS.
AND THAT ALSO THE IMMUNE
MODULATION IS A CRITICAL ASPECT
OF TB MENINGITIS TREATMENT.
SO THE DEBILITATING OUTCOMES
THAT ARE ASSOCIATED WITH TBM
REQUIRES THAT NOVEL STRATEGIES
BE EVALUATED VIA ROBUST
PRE-CLINICAL RESEARCH PRIOR TO
CLINICAL TESTING.
WE CAN'T SIMPLY TAKE THESE DRUGS
AND THE REGIMENS WE'RE
DEVELOPING HERE AND SAYING THE
WORKING AND PULMONARY TB, LET'S
SEE IF THEY WORK WITH TB
MENINGITIS WITHOUT DOING
PRE-CLINICAL WORK.
AND WE DO HAVE PRE-CLINICAL
MODELS TO STUDY, PRE-CLINICAL
ANIMAL MODELS TO STUDY TBM.
PRIMARILY THESE ARE RABBITS AND
MICE.
EXAMPLES INCLUDE
INTRAVENTRICULAR INFECTIONS OF
BOTH RABBITS AND -- MICE WITH
VIER LENT MTB STRAINS AND IT'SS
ABOUT LN FOUND NOS TO KNOCKOUT
MICE WHEN INTERFECTED
INTERVENTRICULARLY -- THE
DISEASE SIMILAR IN THE MICE TO
HUMAN TBM.
IN ADDITION TO THIS WORK THERE'S
BEEN BRAIN SCANS USING RADIO
LABELED ABT BIOTICS THAT HAVE
BEEN ABLE TO ESTABLISH DATA ON
DRUG PENETRATION INTO THE BRAIN
AND CNS.
THE MOST PREVALENT SHOWN IN THIS
FIGURE SEEMS TO BE VERY EASILY
AND EFFECTIVELY ENTER THE BRAIN
COMPARED TO OTHER TB DRUGS.
SO THERE IS A ONGOING CLINICAL
TRIAL NETWORK OR THERE ARE
MULTIPLE CLINICAL TRIALS ONGOING
THAT FIT INTO ONE OF ROUGHLY
THREE DIFFERENT TYPES OF
BUCKETS.
THERE ARE THOSE FOCUSED ON
MODIFYING THE STANDARD OF CARE,
THE STANDARD OF THE ANTIBIOTICS
THAT ARE UTILIZED WHICH IS TWO
MONTHS OF INH AND -- FOLLOWED BY
9 TO 12 MONTHS OF IN H&R
IFAMPISI NE. ALONE.
TESTING HIGHER DOSES OF
RIFAMPISIN OR INH, ALSO
INCLUDING -- STANDARD OF CARE.
IN ADDITION TO THESE STUDY, ONE
THAT HAS RECENTLY STARTED WAS
INCLUDED IN THIS FIGURE OR THIS
TABLE IS THE IMAGINE TRIAL
THAT'S -- THE FIRST TRIAL FROM
ACTG LOOKING AT TB MENINGITIS
REGIMEN STUDYING HIGH DOSE RIF,
HIGH DOSE -- AND PZA.
IN ADDITION TO THOSE STUDIES BE,
THERE ARE OTHERS LOOKING AT
DEXAMETHASONE IN ADDITION TO
STANDARD OF CARE, DEATH MEX ZONE
COMMONLYPRESCRIBED WITH THE STAF
CARE ATTEMPTING TO ALLEVIATE THE
INFLAMMATORY CONDITION WITHIN
THE BRAIN OF TBM.
IT HAS BEEN MILDLY EFFECTIVE.
IT'S EFFECTIVE IN SOME PATIENTS
BUT NOT ALL, SO IF SOME TRIALS
ARE TRYING TO BETTER UNDERSTAND
EXACTLY WHO IS BENEFITING AND
WHY SOME BENEFIT MORE THAN
OTHERS, AND THERE'S ALSO WORK
WITH HIV COINFECTED INDIVIDUALS
TO SEE HOW EFFECTIVE DEX MET
ZONE IS IN THOSE POPULATIONS AS
WELL.
IN ADDITION TO THE STUDIES OF
DEXAMETHASONE, ASPIRIN IS BEING
STUDIED IN MULTIPLE STUDIES.
NATIONAL TO HIGHER DOSES OF
RIF -- COMBINING BOTH OF THESE
WHERE YOU'RE COMBINING THE
CHEMOTHERAPY WITH THE ADJUNCTIVE
THERAPY.
NONE HAVE BEEN GANG BUSTERS AT
THIS POINT.
BUT THEY ARE ONGOING CLINICAL
TRIALS.
I WOULD NOTE ALSO THERE ARE
MULTIPLE CASE REPORTS SHOWING
BENEFITS OF ANTI-TNF GIVEN WITH
SOME TBM PATIENTS, BUT THESE
HAVE NOT REACHED THE LEVEL OF
BEING STUDIED WITH CLINICAL
TRIALS BUT THESE ARE ANOTHER
AREA OF HOST-DIRECTED
THERAPEUTICS THAT ARE BEING
STUDIED IN THE CONTEXT, ARE
BEING LOOKED AT IN THE CONTEXT
OF TBM.
BUT THE REAL NEEDS GOING FORWARD
WITH THE CLINICAL TRIALS REALLY
ARE THERAPEUTIC REGIMENS WITH
IMPROVED CNS PENETRATION AND NOW
THE HOST MODULATING
INTERVENTIONS.
SO A REAL GAP WE WANT TO ADDRESS
WITH THIS INITIATIVE IS LACK OF
TRANSLATIONAL MODELS TO
INTEGRATE PRE-CLINICAL AND
CLINICAL STUDIES, PRIMARILY THE
NEED TO DEVELOP COMPUTATIONAL
AND OTHER SILICONE MODELS TO
FORWARD OR REVERSE TRANSLATE TBM
DATA FROM SMALL ANIMAL MODELS
AND CLINICAL TRIALS, KEY
COMPONENTS OF CLINICAL RESULTS
IN SMALL ANIMAL MODEL STUDIES
ARE THE DRUG PENETRATION INTO
THE CNS AND BRAIN, HOW
EFFECTIVELY THE DRUGS ARE
CROSSING THE BLOOD BRAIN
BARRIER, THE PK/B K/PD ANALYSIS.
TO GET THESE MORE IN SYNC, WE
REALLY WANT TO CONNECT THEM SO
WE KNOW WHAT WE NEED TO BE
STUDYING -- NEED TO BE
OPTIMIZING SMALL ANIMAL MODELS
TO BE EFFECTIVE IN CLINICAL
TRIALS IS A GAP AND ONE WE WANT
TO ADDRESS.
SO THIS INITIATIVE WOULD ENABLE
A MULTIDISCIPLINARY APPROACHES
TO INFORM THERAPEUTIC STRATEGIES
FOR TBM UNTIL SCOPE, WOULD
INCLUDE EVALUATIONS OF NOVEL
APPROACHED TO TBM TREATMENTS IN
PRE-CLINICAL MODELS BEING IT
MICE, RABBITS, POTENTIALLY
NHPs AND WE WOULD WANT TO
ENCOURAGE 3D CEREBRAL ORGANOIDS
OF NOVEL AND EXISTING DRUG
FORMULATIONS TO IMPROVE CNS
PENETRATION INCLUDING
ADVANCEMENT OF PEDIATRIC
FORMULATIONS, IDENTIFYING AND
VALIDATING POTENTIAL HOST WIE
OWE MARKERS FOR DIAGNOSIS AND
VSH OR PROGNOSIS, THIS BEING
ADULTS AND CHILDREN AND
DETERMINING -- EXAMPLES BEING
ADULTS AND CHILDREN AND
DETERMINING HOW HIV AND ART
INFLUENCE BIOMARKER AK CASSIE
AND SELECTION, APPLYING
COMPUTATIONAL -- TO DEVELOP
PARTICULAR INSILICO MODELS TO
INFORM REGIMEN SELECTION
GUIDELINES.
THIS IS BEING DONE IN PULMONARY
TB QUITE EFFECTIVELY.
WE'D LIKE TO ENCOURAGE MOWR OF
THIS BEING DONE WITH TB
MENINGITIS AND PERFORMING
CLINICAL RESEARCH INVOLVING
ALREADY COLLECTED HUMAN SAMPLES.
WHAT WOULD BE OUT OF SCOPE WOULD
BE APPLICATIONS THAT DO NOT
INCLUDE A COMPONENT STUDYING TBM
IN THE CONTEXT OF HIV.
IT WOULDN'T BE EXPECTED TO BE
COMPLETELY -- THE PROJECTS WOULD
ALL NEED TO BE INVOLVING
COINFECTION BUT WE WOULD EXPECT
THEM TO HAVE AT LEAST ONE
INVOLVING COINFECTION.
PULMONARY TB AND OTHER NON-TBM
DRUG OR REGIMEN WOULD BE
EXCLUDED AND CLINICAL TRIALS AND
CLINICAL STUDIES OF PULMONARY TB
REGIMENS APPLIED DIRECTLY TO T
BM.
SO AS THIS IS A U19, THE
EXPECTATION WOULD BE AT LEAST TO
HAVE MULTIPLE RESEARCH PROJECTS,
AT LEAST THREE SYNERGISTIC CROSS
DISCIPLINARY HYPOTHESIS-DRIVEN
RESEARCH PROJECTS, ONE BEING
CLINICAL, ONE PRE-CLINICAL AND
ONE TRANSLATIONAL.
FOCUSED ON AREAS THAT WOULD
INCLUDE OPTIMIZING TB DRUG
COMBINATIONS AND REGIMENS,
EXPANDING DRUG FORMULATION
TECHNOLOGIES TO IMPROVE CNS DRUG
EXPOSURE AND ELUCIDATING EFFECT
OF INFLAMMATORY DAMAGE ON BLOOD
BRAIN BARRIER AND NOVEL DRUG
TARGETS AND WE'D STRONGLY
ENCOURAGE THE INTEGRATION OF
EXISTING DATA/SAMPLE COLLECTIONS
STRONGLY ENCOURAGED.
THE EXPECTATION IS EVERYONE
WOULD HAVE AN ADMINISTRATIVE
CORE WITH PROGRAM ORGANIZED
WHERE THE PROGRAM ORGANIZATION
AND MANAGEMENT SUPERVISION
ACTIVITIES WOULD BE FOCUSED ON
AND THERE WOULD BE A CENTRAL
DATA MANAGEMENT CENTER.
MULTIPLE SCIENTIFIC CORES THAT
WOULD UTILIZE TWO OR MORE OF THE
PROJECTS WITHIN THE PROGRAM.
EXAMPLES WOULD INCLUDE
IMMUNOLOGY, PHARMACOLOGY AND
CLINICAL CORES, CLINICAL SITES
AND LABORATORIES THAT WOULD
ESTABLISH INFRASTRUCTURE AND
EXPERTISE TO CONDUCT RESEARCH
AND DEVELOPMENT OF AN EXTERNAL
SCIENTIFIC ADVISORY GROUP
ESTABLISHED AFTER THE AWARD IS
MADE TO EVALUATE AND ADVISE ON
SCIENTIFIC PROGRESS.
AND ONCE AGAIN, WHERE WE SEE
THIS FITTING IS THE
TRANSLATIONAL STUDIES ARE A GAP
IN DAIDS TBM PORTFOLIO.
AND I'LL JUST NOTE ANNIE
BRIDWELL DID THE LIT REVIEW HERE
AND REALLY PUSHED THIS
INITIATIVE FORWARD EARLY IN THE
YEAR BEFORE SHE LEFT FOR OTHER
OPPORTUNITIES OUTSIDE OF DAIDS.
BUT THERE ARE 14 GRANTS
CURRENTLY IN THE PORTFOLIO OF
NIAID, FIVE OF WHICH ARE IN
DAIDS.
THREE OF WHICH ARE THROUGH A
PREVIOUS PAR INITIATIVE THAT TRP
HAD THAT HAS PRODUCED A PRETTY
EFFECTIVE RESPONSE.
AND FROM THE DAIDS STUDIES, THEY
ARE PRIMARILY FOCUSED ON HUMAN
STUDIES, WHEREAS DAIT AND DMID
HAVE STUDIES ON ZEBRAFISH,
RABBITS AND MICE BUT ONLY ONE
STUDY REALLY COMBINING HUMANS --
AND THIS IS IN OUR PORTFOLIO,
HUMANS AND MICE, SO WHERE WE SEE
THE GAP CURRENTLY IN OUR
PORTFOLIO AND WHERE WE WANT TO
BE TAKING THE TB MENINGITIS
FIELD FORWARD WITH THIS
INITIATIVE IS BUILDING
PRE-CLINICALLING, CLINICAL AND
COMPUTATIONAL TBM COLLABORATIONS
THAT WILL DRIVE MORE PORTABLE
AND THEREFORE MORE TRANSLATABLE
RELEVANT OUTCOMES.
SO OUR REVIEWERS WERE DRS.
ABRAMS AND NDHLOVU.
WE'RE VERY THA THANKFUL FOR YOUR
TIME AND EFFORT IN REVIEWING THE
CONCEPT.
THEY WERE HIGHLY SUPPORTIVE OF
THE RELEVANT AND TIMELY PROPOSE
WILL A.
THEY THOUGHT THE U19 MECHANISM
IS WELL SUITED FOR THE SCOPE OF
WORK ENVISIONED AND COULD
SUCCESSFULLY HARNESS DIVERSE
RESOURCES TO CATALYZE SCIENCE
AND INNOVATION, AND IT WILL
ALLOW FOR TRANSFORMATIONAL
INVESTMENT IN RESEARCH TO FILL A
GAP TOWARDS ADVANCES IN NEW TBM
DRUG REGIMENS.
RECOMMENDATIONS INCLUDE SHOULD
CONSIDER UNDERSCORING THE IMPACT
OF TBM IN PEDIATRIC POPULATIONS
AND THAT CHILDREN ARE A PRIORITY
POPULATION TO INCLUDE.
WE STRONGLY AGREE THAT CHILDREN
ARE AN IMPORTANT POPULATION FOR
TBM RESEARCH AND WILL BE
PRIORITIZING THE INITIATIVE.
I ATTEMPTED TO HIGHLIGHT THEM
MORE IN TODAY'S PRESENTATION.
AND OPPORTUNITIES TO LEVERAGE
NEW INNOVATIONS AND ADVANCES IN
THE USE OF 3D CEREBRAL ORGANOID
MODELS AND OTHER ANIMAL MODELS
SUCH AS NHPs THAT COULD
STRENGTHEN TRANSLATIONAL
COMPONENTS OF THE PROPOSAL.
WE ARE THANKFUL FOR THE
RECOMMENDATION AND AGREE IN
PARTICULAR THAT CEREBRAL
ORGANOID MODELS WOULD STRENGTHEN
THE TRANSLATIONAL COMPONENT OF
THE PROPOSAL AND WILL BE
INCLUDED IN THE INITIATIVE.
SO FOR THAT, I WILL JUST LEAVE
IT HERE AND TAKE ANYBODY'S
QUESTIONS.
THANK YOU FOR YOUR TIME.
HOPE I DIDN'T RUSH TOO FAST
THROUGH THAT.
>> NO, IT WAS GREAT.
STAY UP THERE.
LET'S SEE IF WE HAVE ANY
QUESTIONS.
>> I SAW NOTES BEING TAKEN IN
THE PERIPHERY, SO --
>> WELL, I HAVE A QUESTION ABOUT
WHETHER A DEVICE MIGHT BE
CONSIDERED RESPONSIVE.
IN CANCER, THERE'S A LOT OF
DEVELOPMENT OF AN ULTRASOUND
DEVICE THAT CAN OPEN THE BLOOD
BRAIN BARRIER TRANSIENTLY.
I DON'T KNOW -- I CAN'T SPEAK
FOR IMPLEMENTATION OF SUCH A
THING FOR TB.
BUT WOULD IT BE USEFUL TO KIND
OF AT THIS STAGE IN PRE-CLINICAL
MODELS INCLUDING MICE AND
ORGANOIDS TEST SOMETHING LIKE
THAT?
>> I'M NOT AWARE OF THEM DOING
THAT CURRENTLY.
A LOT OF WHAT I'M KNOWING FROM
THE ANIMAL MODELS RIGHT NOW IS
THE IMAGING, JUST BEING ABLE TO
IMAGE THE BRAIN, BUT I KNOW WE
WOULD CERTAINLY NOT SAY NO TO
THAT.
THE QUESTION OF COST WOULD BE
ONE THAT WOULD NEED TO REALLY BE
SERIOUSLY CONSIDERED.
ANYONE ONLINE?
SORRY.
>> THERE'S NO ONE ONLINE WHO'S
JOINING US BY ZOOM.
NOPE.
WELL, THANK YOU SO MUCH.
>> THANK YOU.
>> OKAY.
YES, AND PAM IS REMINDING ME TO
REMIND YOU TO PLEASE VOTE IN THE
ELECTRONIC COUNCIL BOOK.
AND YOU COULD DO THAT AS I
INTRODUCE ANNE NEILAN FROM THE
OFFICE OF AIDS RESEARCH ADVISORY
COUNCIL BRIEFING.
>> GOOD AFTERNOON, EVERYONE.
I'M PLEASED TO SERVE AS THE
LIAISON TO ARAC FOR THE OFFICE
OF AIDS RESEARCH ADVISORY
COUNCIL OR OARAC.
THANKS FOR THE OPPORTUNITY TO
PROVIDE A SUMMARY OF THE 66TH 6H
OARAC MEETING.
SO THE 66TH OARAC MEETING WAS
HELD VIRTUALLY ON JUNE 20TH
CHAIRED BY DR. IVY TURNBULL,
DEPUTY EXECUTIVE DIRECTOR OF THE
AIDS ALLIANCE FOR WOMEN,
INFANTS, CHILDREN YOUTH AND
FAMILIES, AND THAT INCLUDED A
REPORT FROM OUR ACTING DIRECTOR.
UPDATES ON THE 2026 TO 2030 NIH
STRATEGIC PLAN FOR HIV AND
HIV-RELATED RESEARCH.
A PRESENTATION BY WHITE HOUSE
OFFICE OF NATIONAL AIDS POLICY
DIRECTOR FRANCISCO RUIZ, TWO
PRESENTATIONS ON PERINATAL HIV
RESEARCH AND RESPONSE, AS WELL
AS UPDATES FROM ARAC AND THE NIH
HIV/AIDS EXECUTIVE COMMITTEE AND
ALL OF THE HIV CLINICAL
GUIDELINES GROUPS.
2026 NIH HIV/AIDS PROFESSIONAL
JUDGMENT BUDGET WHICH WAS
RELEASED IN JULY 2024.
FOR EACH FISCAL YEAR, OAR
PREPARES -- WHICH IS A DOCUMENT
THAT SYMPTOMS THE AMOUNT OF
FUNDING NEEDED TO FULLY PURSUE
THE GOALS OF THE RESEARCH AGENDA
ABOVE CURRENT FUNDING LEVELS.
AND IT'S STRUCTURED TO ALIGN
WITH THE STRATEGIC GOALS
BULLETED ON THAT SLIDE, WHICH
ARE FEATURED IN THE NEXT
PROPOSED ITERATION OF THE NIH
STRATEGIC PLAN FOR HIV AND
HIV-RELATED RESEARCH.
AND THE QR CODE ON THE SLIDE
LINKS TO THAT PROFESSIONAL
JUDGMENT BUDGET IF YOU ARE
INTERESTED IN LEARNING MORE
DETAILS ABOUT IT.
DR. FINZI ALSO HIGHLIGHTED
UPCOMING OAR ENGAGEMENT WHICH
INCLUDED IN JUNE THE
MULTIPURPOSE PREVENTION
TECHNOLOGY OR NPT SUMMIT ON
ENVISIONING THE FUTURE OF
HIV/STI PREVENTION AND
CONTRACEPTION.
THE 25TH INTERNATIONAL AIDS
CONFERENCE WAS HELD IN GERMANY,
SESSIONS ON AGING, STIGMA AND
GLOBAL HEALTH RECIPROCAL
INNOVATION.
IN LATE JULY, OAR PARTICIPATED
ON A PANEL AT THE AFRICAN
IMMIGRANT HEALTH RESEARCH
COLLABORATIVE CONFERENCE WHICH
WAS IN BOSTON, MASSACHUSETTS,
AND THAT PANEL BROUGHT TOGETHER
NATIONAL STRATEGIES FOR
SUPPORTING COMMUNITY AND
ACADEMIC PARTNERSHIPS FOCUSED ON
AFRICAN IMMIGRANT HEALTH.
LAST WEEK, AT THE GLOBAL BLACK
PRIDE CONFERENCE IN ATLANTA, OAR
AND THE NIH SEXUAL AND GENDER
MINORITY RESEARCH OFFICE
PRESENTED ON COMMUNITY
PARTNERSHIPS IN THE CONTEXT OF
NIH HIV RESEARCH AND ON
ADVANCING HIV RESEARCH AT NIH
FOR SEXUAL AND GENDER MINORITY
PEOPLE.
AND LASTLY IN A FEW DAYS, THE
U.S. CONFERENCE ON HIV/AIDS WILL
BE HELD IN NEW ORLEANS,
LOUISIANA.
THAT WILL BE IN COLLABORATION
WITH THE NIH TRIBAL HEALTH
RESEARCH OFFICE AND THE INDIAN
HEALTH SERVICE, OAR WILL HOST A
WORKSHOP FOCUSED ON EMERGING
SCIENTIFIC AREAS THAT GUIDE
NIH'S HIV RESEARCH PROGRAM AND
THE IMPACTS ON TRIBAL
COMMUNITIES.
SO AT THAT 66TH OARAC MEETING AS
DR. DIEFFENBACH ALLUDED TO,
THERE WAS A LOT OF DISCUSSION
ABOUT THE 2026 TO 2030 NIH
STRATEGIC PLAN, AND OAR SENIOR
POLICY ADVISOR DR. RACHEL
ANDERSON REPORTED ON THE PROCESS
TO DEVELOP THAT PLAN, INCLUDING
THE REQUEST FOR INFORMATION FOR
THAT PLAN DISTINCT FROM THE
NIAID ONE THAT GENERATED OVER
200 RESPONSES, AND DR. ANDERSON
DISCUSSED HOW THE SOURCES WHICH
ARE DEPICTED ON THE SLIDE ARE
GOING TO INFORM THE DEVELOPMENT
OF THE NEW PLAN WHICH IS
EXPECTED TO LAUNCH DURING THE
SUMMER OF 2025.
DO YOU MIND ADVANCING THE SLIDE
MAYBE ALL THE WAY THROUGH.
THANK YOU.
SO THE NEW PLAN PROPOSES A
FRAMEWORK OF THREE BROAD
RESEARCH GOALS AND ONE CAPACITY
GOAL WITH CORRESPONDING
OBJECTIVES.
SO FOR GOAL ONE, IT IS TO
ENHANCE THE DISCOVERY AND
ADVANCE HIV SCIENCE THROUGH
FUNDAMENTAL RESEARCH AND I'LL
READ OUT THE OBJECTIVES AS I'VE
BEEN ASKED TO DO.
THERE ARE A LOT OF BIG WORDS ON
HERE MEANT TO TOUCH ON THE
SCIENTIFIC AREAS ENCOMPASSED
UNDER EACH ONE.
SO THE OBJECTIVES UNDER GOAL ONE
ARE TO ENHANCE DISCOVERY AND
ADVANCE HIV SCIENCE THROUGH
FUNDAMENTAL RESEARCH,
COMORBIDITIES, COINFECTIONS AND
COMPLICATIONS.
EPIDEMIOLOGIC ASPECTS OF HIV
INFECTION, COINFECTIONS AND
COMORBIDITIES, BEHAVIORAL AND
SOCIAL FACTORS AND PROCESSES.
GOAL TWO IS TO ADVANCE THE
DEVELOPMENT AND ASSESSMENT OF
NOVEL INTERVENTIONS FOR HIV
PREVENTION, TREATMENT, AND CURE.
AND THE OBJECTIVES THERE INCLUDE
PRE-CLINICAL AND TRANSLATIONAL
RESEARCH, CLINICAL TRIALS AND
OTHER INTERVENTION STUDIES OF
PROMISING HIV PREVENTION,
TREATMENT, COMORBIDITIES AND
CURE STRATEGIES, NEW AND
INTEGRATED MODELS OF HIV
PREVENTION, TREATMENT, CARE,
COMORBIDITIES AND CURE RESEARCH
AND SERVICES.
THE THIRD RESEARCH GOAL IS TO
OPT MICE PUBLIC HEALTH IMPACT OF
HIV DISCOVERIES THROUGH
DISSEMINATION, IMPLEMENTATION OF
RESEARCH FINDINGS.
THE CORRESPONDING GOALS ARE
IMPLEMENTATION SCIENCE AND
TRANSLATIONAL RESEARCH,
COMMUNITY ENGAGED AND COMMUNITY
LED HIV RESEARCH, DISSEMINATION
AND COMMUNICATION OF HIV
SCIENCE.
AND THEN THE FOURTH CAPACITY
BUILDING GOAL IS TO BUILD
RESEARCH WORKFORCE AND
INFRASTRUCTURE CAPACITY TO
ENHANCE SUSTAINABILITY OF HIV
SCIENTIFIC DISCOVERY.
WITH OBJECTIVES OF WORKFORCE
CAPACITY STRENGTHENING, RESEARCH
INFRASTRUCTURE AND CAPACITY AND
METHODS AND TECHNOLOGIES.
THREE OAR TASK FORCES WERE
FORMED IN THE SUMMER OF 2024
BASED ON FUNCTIONAL SCIENCE
AREAS, PRE-CLINICAL RESEARCH,
INTERVENTION RESEARCH AND
BEHAVIORAL AND SOCIAL SCIENCES
RESEARCH.
EACH TASK FORCE INCLUDES OARAC
MEMBERS AS WELL AS OTHER
EXTERNAL SUBJECT MATTER EXPERTS
MEANT TO REFLECT A BROAD RANGE
OF EXPERTISE IN HIV SCIENCE, IN
CLINICAL EXPERIENCE, AND IN
LIVED EXPERIENCE WITH HIV.
AND THANKS TO THOSE OF YOU TODAY
WHO ARE -- MANY OF YOU HERE WHO
ARE SERVING ON THOSE TASK FORCE
COMMITTEES.
THE TASK FORCES ARE THEN CHARGED
WITH DEVELOPING RECOMMENDATIONS
FOR FUNDING PRIORITIES UNDER
THOSE BROAD CATEGORIES THAT ARE
THEN GOING TO BE SHARED AT THE
NEXT ORAC MEETING IN OCTOBER.
SO IN THE NEXT PART OF THAT #
6TH OARAC MEETING, FRANCISCO
RUIZ, NAMED DIRECTOR OF THE
WHITE HOUSE OFFICE OF NATIONAL
AIDS POLICY IN 2024 THEN GAVE A
PRESENTATION IN WHICH HE
DISCUSSED HOW ONAP'S VALUES,
EQUITY, ACCOUNTABILITY,
INNOVATION, INCLUSIVITY,
ACCESSIBILITY, ADAPTABILITY AND
COLLABORATION GUIDE THE OFFICE'S
EFFORTS TO IMPLEMENT THE WHITE
HOUSE'S NATIONAL HIV/AIDS
STRATEGY, DISTINCT FROM THE
OTHER STRATEGIES.
MR. RUIZ PRESENTED NEW CDC DATA
REPORTING AN OVERALL 12% DECLINE
IN NEW HIV INFECTIONS IN THE
U.S. FROM 2018 TO 2 2022.
HE CONTEXTUALIZED THOSE FINDINGS
BY NOTING THE SUCCESS OF
PREVENTION STRATEGIES.
HE ALSO ACKNOWLEDGED PERSISTENT
DISPARITIES BY RACE/ETHNICITY
AND SEX WITH 37% OF NEW HIF
INFECTIONS IN BLACK AFRICAN
AMERICAN PEOPLE, AND 81% IN
PEOPLE ASSIGNED MALE AT BIRTH IN
2022.
HE ALSO PRESENTED DATA SHOWING
SIGNIFICANT GEOGRAPHIC
DISPARITIES WITH 49% OF NEW
INFECTIONS OCCURRING IN THE U.S.
SOUTH IN 2022, AND MR. RUIZ ALSO
TOOK THE OPPORTUNITY TO
HIGHLIGHT THE OFFICE OF NATIONAL
AIDS POLICY, THE EFFORTS OF THAT
OFFICE TO OUTREACH TO GROUPS
EXPERIENCING HIGHER RATES OF HIV
OR ADAPTING HIV PREVENTION
PROGRAMS FOR RURAL AREAS IN THE
SOUTH, FOR EXAMPLE.
HE ALSO FLAGGED THE ONAPS' 2024
PRIORITIES WHICH ARE TO
MODERNIZE POLICIES TO ENSURE
THEY'RE BASED ON CURRENT
SCIENTIFIC KNOWLEDGE, TO
ACCELERATE PROGRESS IN THE
FEDERAL HIV RESPONSE AND TO
ADVANCE EQUITY AND ACCESS.
HE ENDED HIS REMARKS WITH A CALL
TO ACTION ENCOURAGING MEETING
ATTENDEES TO RECOMMIT EFFORTS TO
ENDING THE HIV EPIDEMIC.
AT THE END OF JULY, THEY HELD A
SUMMIT THAT FEATURED RISING
LEADERS IN COMMUNITIES THAT
CONTINUE TO BE MOST IMPACTED BY
THE RACIAL INEQUITIES DRIVING
THE HIV EPIDEMIC.
IN THE NEXT PART OF THE MEETING,
THERE WERE PRESENTATIONS ON
PERINATAL HIV RESEARCH AND
RESPONSE.
DR. PLEASE MARTINS PRESENTED BD
TRANSLATIONAL RESEARCH ON THE
USE OF IMMUNOGLOBULIN-BASED HIV
BIOLOGICS TO PREVENT PERINATAL
TRANSMISSION AND THEN
MS. KIMBERLY KENNEDY, BORN WITH
HIV IN THE 1980s, PROVIDED A
VERY MOVING PERSONAL AND
COMMUNITY PERSPECTIVE.
SO DR. MARTINS DISCUSSED HOW HOW
ANTIRETROVIRAL THERAPY OR ART IS
EFFECTIVE IN PREVENTING
PERINATAL TRANSMISSION, ISSUES
SUCH AS UNDIAGNOSED HIV AND
PREGNANT PEOPLE, DRUG TOXICITY
AND RESISTANCE, POOR ADHERENCE
AND STIGMA MAKE IT UNLIKELY IT
ALONE WILL STOP PERINATAL
TRANSMISSION.
HIS TEAM INVESTIGATES DELIVERING
HIV BROADLY NEUTRALIZING
ANTIBODIES TO BOTH PREVENT HIV
TRANSMISSION IN INFANTS AND
CHILDREN AS WELL AS TO PROMOTE
SUSTAINED BIOLOGIC RESPONSE.
SO HE SHOWED DATA SHOWING A
SUBSTANTIAL DELAY IN VIRAL
REBOUND WITH EARLY ART
INITIATION, PROVIDED IN
COMBINATION WITH B NAPS.
WITH CONTINUED RESEARCH, MARTINS
SUGGESTED THE DELIVERY COULD BE
KEY TO SUSTAINED BUY LODGE
REMISSION WITH CHILDREN WITH
HIV -- SO CALLED FUNCTIONAL
CURE.
HE ALSO -- THROUGH
ADENOASSOCIATED VIRUS RISK
FACTORS COULD THEORETICALLY
PROVIDE IMMUNITY THROUGHOUT
INFANCY, WITH DURABILITY PERHAPS
LASTING MANY YEARS THROUGH EARLY
ADULTHOOD.
THEN MS. CANADY WHO I MENTIONED
BORN WITH HIV IN 1986 DESCRIBED
HER EXPERIENCE GROWING UP IN THE
EARLY STAGES OF THE HIV
EPIDEMIC, BEFORE ART WAS
AVAILABLE, SHE NOTED THAT TODAY
THERE ARE 13,000 PEOPLE IN THE
U.S. WITH HIV-ACQUIRED PERINAY
NATELY, MANY NOW IN THEIR 30s
AND 40s, AND SHE NOTED THIS
POPULATION WILL CONTINUE TO AGE
AND EXPERIENCE HIV AND
AGE-RELATED COMPLICATIONS AND
SHE CALLED ON MEETING ATTENDEES
VERY SPECIFICALLY TO PRIORITIZE
RESEARCH TO ADDRESS THE MEDICAL,
MENTAL HEALTH AND SOCIAL NEEDS
OF LONG-TERM SURVIVORS WITH HIV,
PARTICULARLY THAT WAS BORN WITH
HIV.
THE 66TH OARAC MEETING CLOSED
THEN WITH UPDATES FROM ARAC
PROVIDED BY DR. ABRAMS AND FROM
THE NIH AIDS EXECUTIVE
COMMITTEE, AS WELL AS UPDATES
FROM THE HIV CLINICAL GUIDELINES
WORKING GROUPS OF OARAC AND FOR
THOSE WHO ARE NOT FAMILIAR WITH
THEM, THOSE ARE THE GROUPS WHICH
DEVELOP THE HIV CLINICAL
PRACTICE GUIDELINES THAT INFORM
CLINICAL PRACTICE IN THE U.S.
AND AROUND THE WORLD.
AS A REMINDER, RECORDINGS OF --
MEETINGS MINUTES AND SUMMARIES
OF THE OARAC MEETINGS ARE
AVAILABLE ON OUR WEBSITE.
THE NEXT MEETING WILL BE
VIRTUAL, THURSDAY, OCTOBER 24TH,
2024.
AS MENTIONED THAT MEETING WILL
FEATURE REPORT OUTS FROM THE HIV
STRATEGIC PLANNING TASK FORCES.
AS WELL AS A REVIEW OF THE
ORIGINS OF --CAPAVIR, AS USUAL
THE MEETING WILL BE VIDEOCAST
FOR PUBLIC VIEWING.
THANK YOU.
ANY QUESTIONS?
IF THERE'S TIME?
>> THERE'S PLENTY OF TIME.
ANY QUESTION FORCE ANNE?
NO?
I DON'T SEE ANY.
THANK YOU VERY MUCH.
WE ARE WAY AHEAD OF TIME.
EVERYONE HAS VOTED, BY THE WAY.
THANK YOU FOR THAT.
WE CAN TAKE A BREAK NOW, AND
RECONVENE AT THE TOP OF THE
HOUR. 2:00 EASTERN.
WELCOME BACK, EVERYONE.
NICK BUSHAR WILL NOW GIVE US AN
UPDATE ON THE NIAID STRATEGIC
PLAN, THE RFI RESPONSES,
RESPONSES TO THE RFI.
>> GREAT, THANK YOU VERY MUCH.
AND THANK YOU VERY MUCH FOR THE
OPPORTUNITY TO COME TODAY.
I PUT ON A SUIT SO THE KIDS CAN
FEEL LIKE DAD IS DOING SOMETHING
IMPORTANT AT WORK.
THEY WERE QUITE SURPRISED TO SAY
THE LEAST THAT DAD HAD A TIE ON
THIS MORNING.
TODAY I'M GOING TO BE TALKING A
LITTLE BIT ABOUT THE NIAID
STRATEGIC PLAN, IN PARTICULAR,
THE RESPONSES TO THE RFI.
AS CARL MENTIONED EARLIER, THE
STRATEGIC PLAN IS MEANT TO BE
BOTH AN ORGANIZATIONAL EXERCISE
AND ALSO AN OPPORTUNITY TO KIND
OF PARTNER WITH THE PUBLIC AND
GET A LOT OF INPUT SO THAT WE
CAN CREATE THE PLAN MOVING
FORWARD.
SO I'M GOING TO START A LITTLE
BIT ON WHAT I THINK IS
EVERYBODY'S MOST EXCITING TOPIC
OF THE DAY, THE STRATEGIC PLAN.
I WILL KEEP THIS BRIEF AND
ORGANIZED FOR EVERYBODY, BUT
SUFFICE IT TO SAY, IT IS
IMPORTANT BECAUSE IT GIVES A
LITTLE BIT OF CONTEXT INTO WHEN
WE START GOING THROUGH SOME OF
THE RFI RESPONSES, A BIT OF THE
ORIGIN, WHERE THEY CAME FROM,
AND IN PARTICULAR, WHAT THEY SAW
WHEN THEY WERE RESPONNING IN
PARTICULAR.
RESPONDING IN
PARTICULAR.
SO THE PREVIOUS STRATEGIC PLAN
WAS LAST UPDATED IN 2 2017 AND
OBVIOUSLY WITH SOME CHANGES IN
THE GLOBAL LANDSCAPE OF
INFECTIOUS DISEASES SINCE THEN,
AS WELL AS THE INTRODUCTION OF A
NEW DIRECTOR TO NIAID, IT WAS
REALLY TIME FOR AN UPDATE.
AND I DO MENTION THIS BECAUSE
REALLY WHEN YOU LOOK THE A STWRA
STRATEGIC PLAN, ONE OF THE KEY
THINGS IS ENGAGING IN FORWARD
THINKING.
I KNOW THAT SOUNDS VERY SIMPLE,
ENOUGH TO SAY, HOWEVER, YOU'D BE
AMAZED HOW OFTEN WHEN YOU START
IN THESE PROCESSES, YOU OFTEN
KIND OF LEAN BACK ON YOUR HEELS
AND SAY, WELL, WE'VE BEEN DOING
THIS, WE SHOULD JUST KEEP DOING
WHAT WE'RE DOING.
HOWEVER, THIS IS REALLY AN
OPPORTUNITY FOR US TO LOOK AT
THE NEXT FIVE YEARS OF NIAID IN
PARTICULAR.
WHAT I'M GOING TO REVIEW TODAY
IS THE NEXT FIVE YEARS OF HIV
RESEARCH AS WELL.
SO I'M GOING TO REMARKABLY
OVERSIMPLIFY THE STRATEGIC
PLANNING PROCESS INTO THREE
STEPS SO YOU GET A LITTLE
PERSPECTIVE ON THE RFI ITSELF.
SO THE WAY WE STARTED WAS REALLY
TO ESTABLISH THE INITIAL
PRIORITIES FOR THE INSTITUTE, AS
WELL AS START TO UNDERSTAND A
LITTLE BIT OF THE OBJECTIVES.
SO NOT TO DIG TOO MUCH INTO
TERMINOLOGY, HOWEVER WE START
OUR TOP TIER IS REALLY THE
INSTITUTE PRIORITIES AND THERE
ARE FIVE OF THOSE.
THEN WE TALK ABOUT OBJECTIVES.
SO WHAT ARE WE TRYING TO DO IN
EACH OF THOSE PRIORITIES.
THEN WE KIND OF WORK OUR WAY
DOWN INTO FOCUS AREAS AND THEN
GOALS.
FOR THE SAKE OF TODAY, WE'LL
REALLY KEEP IT HIGH LEVEL AT
BOTH THE PRIORITY LEVEL AND THE
OBJECTIVE LEVEL.
NOW THIS IS IMPORTANT BECAUSE
WHEN WE SENT OUT THE RFI, SO THE
FIRST STEP WAS TO ESTABLISH THE
PRIMARY INSTITUTE PRIORITIES,
AND AS YOU CAN SEE HERE, THEY
ARE BASICALLY THE BREAD AND BUT
ERT OFBUTTER OF THE INSTITUTE, H
IMMUNOLOGY AND PATHOGEN BIOLOGY,
THEN PRIORITY TWO STARTS GETTING
INTO APPLYING THAT RESEARCH TO
INFECTIOUS DISEASES OUTSIDE OF
HIV/AIDS.
THE THIRD PRIORITY WHICH I'LL
FOCUS ON TODAY ARE HIV
PORTFOLIO.
OUR FOURTH PRIORITY IS APPLIED
RESEARCH IN IMMUNOLOGICAL
DISEASES AND TRANSPLANTATION,
AND THEN OUR FIFTH PRIORITY IS
BIOPREPAREDNESS, REALLY
PREPARING FOR AND RESPONDING TO
BIOLOGICAL INCIDENTS THAT AFFECT
PUBLIC HEALTH.
FLAD TO THESE, WE ALSO HAVE --
THE PLAN REALLY EXPANDS INTO
BOTH OPERATIONAL CAPACITY
PRIORITIES, CROSS-CUTTING
THEMES, A NUMBER OF DIFFERENT
THINGS THAT REALLY GET
INTEGRATED THROUGHOUT THE PLAN.
AND I SAY THIS BECAUSE I THINK
SOMETIMES WHEN WE LOOK AT SOME
THINGS, EVEN THE RFI AND
RESPONSES, WE GET FOCUSED TO SAY
IT'S NOT WORD FOR WORD, THAT
MUST MEAN THEY'RE EITHER NOT
DOING IT OR REALLY NEED TO
EXPAND.
SO IN SOME CASES I THINK THE
GREATER HOLISTIC PLAN OF SOME OF
THESE THINGS WILL BE ADDRESSED.
HOWEVER, FOR THE SAKE OF THIS
WHEN WE SENT OUT THE RFI, PEOPLE
REALLY WENT DOWN THE LIST AND
RESPONDED JUST WITHIN EACH
PRIORITY.
WE'RE GOING TO FOCUS EXCLUSIVELY
ON THE THIRD PRIORITY, HIV/AIDS.
SO THAT IS THE FIRST STEP, IS
ONCE WE ESTABLISH THE RESEARCH
PRIORITIES, WE THEN SENT OUT AN
RFI IN ORDER TO GARNER INBUT
THAT REALLY -- THAT ROUGH CUT
BASICALLY.
WE STARTED WITH INSTITUTE
PRIORITIES AND OBJECTIVES, THEN
AN TO SAY OKAY, WHERE DO YOU
THINK THINGS NEED TO GO, WHERE
DO WE THINK THE RESEARCH NEEDS
TO BE.
THEN AFTER THAT, WE ARE IN THE
PROCESS, CARL SHOWED A SLIDE OF
THE TIMELINE, WE'RE IN THE
PROCESS OF BOTH INTEGRATING THAT
INPUT AND THEN WORKING WITH THE
DIVISION AND PROGRAMS TO DEVELOP
THE PLAN ITSELF.
SO SPECIFICALLY FOR PRIORITY
THREE, THIS IS THE ADVANCE AND
APPLY KNOWLEDGE OF HIV/AIDS TO
END THE HIV EPIDEMIC THROUGH THE
DEVELOPMENT OF SAFE AND
EFFECTIVE PREVENTION, TREATMENT
AND CURE STRATEGIES.
AND FOR THE SAKE OF THE
DISCUSSION TODAY, THESE ARE THE
PRIMARY OBJECTIVES WITHIN THE
HIV/AIDS PRIORITY.
THIS IS REALLY NOT ALL THAT
DIFFERENT FROM OAR, WHICH I'LL
TALK ABOUT IN A LITTLE BIT.
ADVANCING HIV PREVENTION
STRATEGIES, AND THEN THIS WILL
BE DEVELOPING AND ASSESSING HIV
PREVENTION APPROACHES.
THEN HERE YOU HAVE YOUR
COINFECTIONS/COMORBIDITIES
ASSOCIATED WITH HIV AND THEN A
VERY IMPORTANT FOSTERING
COMMUNITY INVOLVEMENT IN ALL
STAGES OF THE RESEARCH PLANNING
AND IMPLEMENTATION.
SO WITH THAT PRIORITY AND THAT
KIND OF SKELETON DRAFT IN MIND,
WE WENT OUT WITH AN RFI.
THIS RFI WAS OPEN FOR 90 DAYS
FROM FEBRUARY 26TH THROUGH MAY
27TH.
AND IT INCLUDED BASICALLY EACH
OF THE PRIORITIES AND A LITTLE
BIT ABOUT THEM TO THE PUBLIC SO
THAT THEY COULD THEN RESPOND.
AS CARL MENTIONED, WE WERE
THRILLED WITH THE NUMBER OF
RESPONSES WE GOT FROM THE RFI.
THEY WERE REMARKABLY THOUGHTFUL,
THEY WERE WELL ARTICULATED AND
THEY BOTH -- SO WHEN I SAY
THERE'S 63 TOTAL RESPONSES,
PLEASE KEEP IN MIND, THIS IS
OFTEN A CONGLOMERATE OF AN
ENTIRE ORGANIZATION RESPONDING
TO EACH INDIVIDUAL PRIORITY.
SO APPROXIMATELY 200 PAGES WORTH
OF RESPONSES TO THE RFI THAT WE
WENT THROUGH.
AND AGAIN, THEY WERE ALL VERY,
VERY WELL WRITTEN AND
ARTICULATE.
AND ACTUALLY A LITTLE SHOUT OUT
TO THE POLICY PLANNING AND
EVALUATION OFFICE WHO WENT
THROUGH IT, AND KIND OF
CONDENSED IT SO THAT WE COULD
HAVE A HALF-DAY RETREAT AS AN
INSTITUTE, WHERE WE PROVIDED
BOTH NIAID LEADERSHIP, THE
ENTIRETY OF THE RESPONSES, AND
THEN WE PROVIDED A BIT OF AN
OVERVIEW SO WE COULD DISCUSS
THEM AS AN INSTITUTE ALL
TOGETHER.
AND I WOULD SAY THE OUTCOME OF
THAT RETREAT IS ACTUALLY BEING
INCORPORATED INTO THE PLAN AS WE
SPEAK.
SO I'M GOING TO FOCUS ON A
COUPLE OF THE MAIN TOPICS THAT
CAME OUT OF THE RFI FOR HIV
RESEARCH.
SO A COUPLE THINGS ABOUT IT
BEFORE I ACTUALLY GET INTO IT.
I'LL ACTUALLY SHOW SOME OF THEM
RIGHT HERE.
SO FOR SAKE OF TODAY OBVIOUSLY
I'M NOT GOING TO FOCUS ON THE
ENTIRE NIAID PORTFOLIO, HOWEVER,
I SHOULD SAY A LOT OF WHAT
YOU'RE GOING TO HEAR FOR
HIV/AIDS WERE PRETTY COMMON
ACROSS THE SPECTRUM.
NOT SURPRISINGLY, I WOULD SAY.
SO I THINK WHEN YOU'RE LOOKING
FORWARD, FORWARD THINKING FOR AN
INSTITUTE, IT REALLY COMES DOWN
TO EXPANDING, GROWING, THINGS OF
THAT NATURE.
I SHOULD MENTION IN ALMOST EVERY
SINGLE ONE, PARTICULARLY FOR
HIV, IT WAS STARTED WITH REALLY
LAUDING THE WORK OF THE DIVISION
OF AIDS AND HOW MUCH PROGRESS
HAS BEEN MADE SO FAR.
SO I WANTED TO START WITH THAT
BECAUSE DON'T WORRY, WE SHARED
THE GOOD THINGS AS WELL AND ALL
THE POSITIVES BEFOREHAND, BUT I
WOULD SA SAY THAT A LOT OF WHAT
CAME IN REALLY LOOKED TOWARDS
THE FUTURE AND HOW TO BUILD ON
THE HIV PORTFOLIO.
THESE ARE SOME OF THE MAIN
TOPICS THAT REALLY CAME IN FROM
THE RFI.
THIS INCLUDED EXPANDING HIV/AIDS
RESEARCH, CLEARLY COMORBIDITIES
AND COINFECTION, THERE WAS A BIG
FOCUS ON IMPLEMENTATION SCIENCE,
INCLUDING BEHAVIORAL AND A
SOCIAL RESEARCH, AND THEN HEALTH
DISPARITIES, INCLUSION, WOMEN'S
HEALTH AND GLOBAL HEALTH.
THIS IS BY NO MEANS I WOULD SAY
ENTIRELY COMPREHENSIVE.
THIS IS A SUMMARY OF A LOT OF
WHAT WE FOUND IN THE RFI.
SO THE WAY WE APPROACHED KIND OF
DIGESTING THIS AMOUNT OF
INFORMATION IS WE ACTUALLY TRIED
A FEW DIFFERENT WAYS OF LOOKING
HOLISTICALLY AT THAT MANY
DIFFERENT INDIVIDUAL RESPONSES
AND WE FOUND THAT NO MATTER HOW
WE REALLY BROKE IT DOWN INTO,
SAY, OUTLINES OR BULLET POINTS,
YOU REALLY DESTROYED THE CONTENT
OR REALLY THE TONE OR
CONNOTATION.
SO WE FOUND THAT QUOTES AND
PROVIDING THOSE DIRECTLY WAS
OFTENTIMES THE BEST WAY TO
REALLY CONVEY WHAT THE MESSAGE
WAS OF THE RESPONSE.
SO AS I MENTIONED ONE OF THE
FIRST KIND OF MORE HOLISTIC
COMMENTS THAT WE GOT IN WAS
LOOKING AT EXPANDING THE
HIV/AIDS PORTFOLIO.
AND SOME OF THESE REALLY BUILT
ON A LOT OF THE SUCCESSES THAT
WERE THEN ATTRIBUTED TO THE
PORTFOLIO.
SO ESSENTIALLY HOW CAN WE APPLY
THAT TO OTHER AREAS OF NIAID IN
GENERAL.
SOME OF THIS CAME -- I SHOULD
MENTION THAT NOT ONLY WAS IT
JUST BUILDING ON THE RESOURCES
THAT WE HAD, BUT ALSO LOOKING AT
THINGS LIKE COMORBIDITIES AND
COINFECTIONS.
AND THIS IS ONE OF THE PRIMARY
TOPICS.
SO WE RECEIVED A NUMBER OF
DIFFERENT TOPICS HERE LOOKING
AT, SO AS HIV RESEARCH HAS
ENABLED PEOPLE TO LIVE LONGER
LIVES, SO HAS THE INDUCTION AND
I WOULD SAY THE FOCUS ON MORE
COMORBIDITIES AND COMORTALITIES
THAT OCCUR ACROSS THE LIFESPAN,
AND WE RECEIVED A NUMBER OF
DIFFERENT RESPONSES LOOKING AT
BOTH AUTOIMMUNITY, OTHER IMMUNE
BIOLOGICAL EFFECTS AND IMPACTS.
THIS INCLUDED OTHER THINGS LIKE
CARDIOVASCULAR DISEASE,
METABOLIC DISEASES, DIABETES AND
BEAST.
OBESITY.
THE TERM SYNDEMIC COME UP A LOT,
LOOKING AT OTHER RELATED
INFECTIONS.
STIs, HEPATITIS, THINGS LIKE
THAT, VIRAL HEPATITIS.
AND THESE ARE LISTED HERE UNDER
THE COINFECTIONS AS WELL.
IN ADDITION TO PROVIDING MORE OR
LESS THE BREADTH OF WHAT
NIAID -- THE NIAID PORTFOLIO
THEY WERE LOOKING TO SAY COULD
BE COVERED HERE, THEY ALSO
TALKED ABOUT POINT OF CARE
DIAGNOSTICS, AND PARTICULARLY
FOR COINFECTIONS.
NOT SURPRISINGLY, THERE WAS A
LOT OF TALK ABOUT TUBERCULOSIS
AND INCREASED INVESTMENT IN TB
VACCINE.
AND ALSO INCLUDING PARTICULAR
POPULATIONS IN TB STUDIES.
IN ADDITION, THEY TALKED ABOUT
CLINICAL TRIAL CAPACITY TO
ADDRESS TB AND COINFECTIONS AND
CO-MORBIDITY.
SO I DO LIKE TO STOP AT THIS
POINT TO SAY THESE ARE THE
COMMENTS THAT CAME IN.
A LOT ARE ALREADY BEING
ADDRESSED IN THE PLAN OR ALREADY
INCLUDED IN THE PLAN.
SO I SHOULD SAY THAT EVEN SINCE
SOME OF THE LANGUAGE HAS BEEN
MODIFIED OR SOME OF THE
SPECIFICS THAT WE GATHERED FROM
THE RFI WERE ALREADY INCLUDED IN
THE PLAN.
IN ADDITION, ONE OF THE COMMENTS
THAT WE GOT IN WAS ON
IMPLEMENTATION SCIENCE,
INCLUDING BEHAVIORAL AND SOCIAL
RESEARCH.
AS I MENTIONED BEFORE, THE TONE
OF SYNDEMIC FOCUSED CARE
INCLUDING MENTAL HEALTH,
SUBSTANCE DISORDER TREATMENT AND
MANAGEMENT CAME IN.
AND EXPANDING ENGAGEMENT OF
COMMUNITIES IN HIV PREVENTION.
?AD, THIN ADDITION THERE WAS A E
FOCUS ON THE SOCIAL ASPECT AND
SOCIAL RESEARCH AND REALLY THIS
INCLUDED THE POPULATION-LEVEL
IMPACT OF BIOMEDICAL ADVANCES.
SO HOW CAN WE REALLY TURN THE --
I WOULD SAY THE SPECIFIC ADVANCE
INTO MORE PUBLIC SUPPORT, I
WOULD SAY, FOR THE DISEASE.
AND THEN IMPLEMENTATION SCIENCE
BASICALLY ENSURING THAT THIS R &
D IS TRANSLATED INTO A PUBLIC
HEALTH IMPACT AND REALLY
STUDYING HOW BEST TO IMPLEMENT
THESE INTERVENTIONS.
LET ME PAUSE THERE.
ARE THERE ANY QUESTIONS?
GENERALLY I KNOW WE WAIT UNTIL
THE END, IS IT OKAY IF WE STOP
TO GO THROUGH SOME QUESTIONS
NOW?
OKAY.
ARE THERE ANY QUESTIONS AT THIS
POINT?
BECAUSE THERE'S A COUPLE MORE
SLIDES BUT I KNOW THERE'S A LOT
OF MATERIAL TO GO THROUGH IF
ANYBODY HAD ANY -- PLEASE.
>> THANKS.
I APPRECIATE THE OPPORTUNITY TO
ASK THE QUESTION NOW.
SO I WAS WONDERING ABOUT
INVESTIGATING VACCINE AND
TREATMENT HESITANCY TO MAXIMIZE
UPTAKE.
I THINK IT'S A REALLY IMPORTANT
ISSUE AND I HAVE TWO QUESTIONS
ABOUT IT.
ONE IS I'VE ALWAYS BEEN CURIOUS
ABOUT MONOCLONAL ANTIBODIES AND
WHETHER THERE IS A DIFFERENT
KIND OF HESITANCY THAT COULD BE
AT PLAY OR NOT.
AND I DON'T KNOW HOW MUCH
RESEARCH THERE IS ABOUT THAT.
I'VE SORT OF STRUGGLED TO FIND
IT.
AND THEN THE SECOND THING IS, I
WAS WONDERING IF THINGS LIKE
COMMUNICATION SCIENCE ARE PART
OF HOW YOU MIGHT DO THAT, OR IF
THAT'S NOT REALLY SOMETHING THAT
FITS INTO DAIDS' PORTFOLIO.
>> I'D DEFER TO EITHER CARL
OR --
>> SO I THINK WHEN WE LOOK AT A
LOT OF THESE COMMENTS, WE HAVE
TO THINK ABOUT AIDS RESEARCH
WRIT LARGE.
AND THAT WE ARE 27 INSTITUTES
AND CENTERS AT THE NIH, AND FOR
SOME OF THESE ACTIVITIES, LIKE
STUDYING SUBSTANCE USE,
SIGNIFICANT BEHAVIORAL RESEARCH,
THERE ARE ENTIRE INSTITUTES
DEVOTED TO THOSE ACTIVITIES.
AND WE HAVE WORKED CLOSELY WITH
NIDA AND NIMH TO BUILD THOSE
BRIDGES.
SO I WANT TO JUST REMIND PEOPLE
THAT WE ARE NOT THE SOLE ARBITER
OF ALL AIDS RESEARCH HERE.
SO I THINK THAT THERE IS THAT
ASPECT THAT WE NEED TO DEAL
WITH.
ALSO WE HAVE TO THINK ABOUT --
WE'RE ALSO NOT SOCIAL SCIENTISTS
THAT DEAL IN COMMUNICATION.
SO I DON'T KNOW HOW -- I THINK
THERE ARE PARTNERSHIPS THAT WILL
NEED TO BE FORMED FOR THAT.
FOR EXAMPLE, DURING COVID, WE
BUILT COLLABORATIONS WITH --
THROUGH THE HANK, HIV/AIDS
COORDINATING ACTIVITIES, TO
REALLY TAKE ADVANTAGE OF PEOPLE
LIKE MICHELLE ANDRESAK AND
OTHERS AND THEIR COMMUNICATION
SKILLS.
SO I THINK STUDYING THAT, THOSE
ASPECTS, DOESN'T NECESSARILY
HAVE A HOME HERE.
THAT DOESN'T MEAN IT'S NOT
IMPORTANT.
WE DID NOT -- TO OUR CREDIT, WE
ASKED FOR HIV WRIT LARGE.
BECAUSE WHAT THAT HELPS US DO IS
BUILD OUT THE COLLABORATIONS WE
NEED TO CREATE IN ORDER TO
ADDRESS THE FULL SCOPE OF WHAT
IS BEING ASKED FOR HERE.
>> THANKS.
IT SOUNDS LIKE MAYBE FOR THAT
COMMENT, IT'S A COMMENT TAKEN
UNDER ADVISEMENT FOR THE FUTURE
BUT MAYBE NOT DIRECTLY MAKING
ITS WAY INTO THE PLAN.
>> I JUST AM CURIOUS ABOUT
CALLING POPULATION LEVEL IMPACT
SOCIAL RESEARCH.
AND WHAT THE THINKING IS TO
CLASSIFY IT AS SOCIAL RESEARCH.
I THINK POPULATION LEVEL IMPACT
WOULD BE MORE EPIDEMIOLOGIC.
UNLESS I'M MISUNDERSTANDING
WHAT'S MEANT.
>> I'D HAVE TO LOOK AT THE
COMMENT AT LARGE WHEN WE WENT
THROUGH IT.
PERHAPS IT WAS IN THE CONTEXT OF
A MORE SOCIAL DIRECTED COMMENT,
BUT --
>> OKAY.
>> I CAN'T HELP BUT COMMENT ON
THE PREVIOUS SLIDE, THE TWO
COMMENTS ABOUT REDISTRIBUTING
THE BUDGET.
I MEAN, THIS IS JUST A PERSONAL
OPINION, BUT I THINK THAT'S WHAT
I'M SUPPOSED TO DO.
WE STILL HAVE ISSUES AND A LOT
OF WORK TO DO.
YOU KNOW, THE EPIDEMIC IS NOT
THE SAME AS IT WAS IN THE PAST.
WE HEARD SOME OF THAT EARLIER
TODAY.
SO I GUESS I WOULD JUST LOBBY
FOR MORE COLLABORATION WITH
OTHER SCIENTISTS OUTSIDE OF
DAIDS, BUT ON BRINGING EXPERTISE
THAT'S OUTSIDE OF HIV RESEARCH
TO BEAR ON HIV RESEARCH QUEST
QUESTIONS MIGHT BE A REALLY GOOD
WAY TO SHARE THE BUDGET.
>> SO THESE REPRESENTED -- SO
IT'S INTERESTING THAT THERE'S A
NUMBER OUT THERE, EIGHT
RESPONSES.
SO THIS REPRESENTED A MINORITY
VIEW.
IT WASN'T LIKE 60 OUT OF 60 SAID
TAKE THE AIDS BUDGET AND BUST IT
APART, SPREAD IT OUT LIKE
FERTILIZER ALL OVER THE NIH
LAWN.
BUT REALLY, THERE IS -- THIS
GETS BACK TO THE LATENT JEALOUSY
THAT THERE IS A SETASIDE FOR
HIV, AND THAT TO A CERTAIN
EXTENT THROUGH THE COLLECTIVE
ACTIVITIES AT THE NIH, IT IS
PRETTY WELL ORGANIZED COMPARED
TO OTHER FIELDS.
AND SO I THINK THERE IS A LOT OF
THOSE KINDS OF ACTIVITIES, BUT I
AGREE THAT WHERE WE WILL NEED TO
GO AS DRUGS GET BETTER,
ANTIRETROVIRALS GET BETTER, IS
TO BROADEN OUT AND BRING IN
ADDITIONAL COLLABORATORS AS WE
DEAL WITH AGING, AS WE DEAL WITH
BONE DISEASE, AS WE DEAL WITH
OARL OTHER -- THE COMORBIDITIES
ASSOCIATED WITH HIV THAT ARE
MOST EXACERBATED BY LONG-TERM
ANTIRETROVIRAL TREATMENT IS
BUILDING THOSE PARTNERSHIPS.
SO I AGREE WITH YOU, RICH.
>> QUICK QUESTION.
>> BY ALL MEANS.
>> I DON'T KNOW IF YOU HAD
THIS -- YOU SHOWED IT ON THE
SLIDE BUT I DON'T KNOW IF IT
CAME UP IN TERMS OF THE REVIEW
CYCLE AND THAT'S ONE OF THE
THINGS WE OFTEN HERE, IS THAT
THERE'S A DIFFERENT REVIEW CYCLE
FOR HIV.
AND I ALWAYS STRESS THAT IT
SEEMS TO ENCOURAGE MORE CROSS
COLLABORATION SO THAT THERE'S
PEOPLE WHO MIGHT NOT CONSIDER
HIV AS PART OF THEIR RESEARCH
BUT TRY TO FIGURE OUT A WAY TO
DO SO BECAUSE IT HAS AN ENHANCED
CYCLE.
I WAS WONDERING IF THAT CAME UP
IN ANY OF THE COMMENTS YOU GOT.
>> I DON'T BELIEVE SO
SPECIFICALLY.
THE UNIQUE REVIEW CYCLE OF HIV.
I THINK DEPENDING ON OBVIOUSLY
AS CARL MENTIONED THE TYPES OF
RESPONSES FROM A MORE GLOBAL
LEVEL BECAUSE IT WASN'T AS
FOCUSED ON HIV, PERHAPS
DIDN'T -- IT DIDN'T REACH THAT
MARK.
>> WE HAVE A QUESTION ONLINE,
AND I WILL ASK YOU TO --
>> HI.
SO -- I'M IN SAN FRANCISCO, I
CAN'T BE THERE IN PERSON.
I WANTED TO ECHO BOTH WITH CARL
AND DR. D'AQUILA MENTIONED AS
WELL BUT ALSO INCREASING
COLLABORATIONS ACROSS
INSTITUTES, OBVIOUSLY THIS IS A
MULTI-INSTITUTE APPROACH TO HIV
AND A LOT OF THE SUCCESSES ARE
BECAUSE OF THESE COLLABORATIONS,
AND ALSO WONDERING IF THERE'S
FURTHER DISCUSSION OF EVEN TO
IMPROVE OR ENHANCE SOME OF THE
EXISTING COLLABORATIONS WHICH I
KNOW ARE QUITE STRONG BEING WITH
EITHER COST SHARING ACROSS
DIFFERENT -- STRUCTURES,
MULTI-INSTITUTE CONTRIBUTIONS,
THINGS LIKE THAT.
AND COULD SEE THIS AS A
POTENTIAL OPPORTUNITY TO KIND OF
STREAMLINE SOME OF THOSE
PROCESS, ESPECIALLY WHEN
COMORBIDITIES SUCH AS HEART,
LUNG OR SUBSTANCE USE HAVE
DIRECT INTERACTION WITH VIRAL
PERSISTENCE OR IMMUNOLOGICAL
FACTORS AS WELL.
SO I THINK SOMETIMES FOR
INVESTIGATORS, IT CAN BE A BIT
CONFUSING TO NAVIGATE WHICH ENS
INSTITUTE TO APPLY, DIFFERENT
RFAs COMING FROM DIFFERENT
REGIONS SO THIS IS A GREAT
OPPORTUNITY TO REALLY SOLIDIFY
THESE AMAZING COLLABORATIONS
THAT HAVE ALREADY BEEN FORMED.
>> ABSOLUTELY.
I THINK AS PART OF THE HOLISTIC
PART, I WAS TRYING TO GIVE
ENOUGH WARNINGS WHEN YOU'RE
TAKING A SMALLER SN SNIPPET THAT
SOME OF THESE THINGS WILL BE
INCLUDED IN THE MORE HOLISTIC
PLAN ITSELF, INCLUDING
COLLABORATION.
THAT CAME UP AS ONE OF THE KEY
THINGS.
I'M ACTUALLY REALLY GLAD YOU
BROUGHT THAT UP AS WELL.
PERHAPS I SHOULD HAVE LEFT THAT
QUOTE TO THE END, BECAUSE PART
OF THE REASON OF ACTUALLY SAYING
SOMETHING AND ACTUALLY PUTTING
THAT UP IS THAT WHAT WE DO WITH
THESE RFI RESPONSES VARIES.
SO WHAT I MEAN BY THAT IS THAT
WHERE RELEVANT AND WHERE
SPECIFIC, WE CAN INCORPORATE
THIS INTO WHAT WE DO AS A
MISSION.
IN SOME CASES, I THINK IT REALLY
REQUIRES JUST A BETTER
ARTICULATION OF WHAT WE'RE
ALREADY DOING.
AND IN SOME CASES LIKE THAT, I
WAS GOING TO GET TO THAT PUNCH
LINE AT THE END BUT I DIDN'T
MEAN TO INSTILL A BIG FEAR IN
FOLKS THAT THAT WAS WHERE WE
WERE GOING, BUT IN SOME CASES I
AGREE, A LOT OF IT COMES DOWN
TO, AS CARL MENTIONED, HOW WE
COLLABORATE.
WE ARE NOT THE SOLE HIV -- YOU
KNOW, THERE ARE DIFFERENT PARTS
OF THIS WHOLE THAT I THINK A LOT
OF PEOPLE DON'T RECOGNIZE.
AND BOTH BEING CLEAR IN WHERE
OUR SWIM LANE IS BUT ALSO HOW WE
PARTNER WITH OTHERS IS CRITICAL.
AND AS FARTH PART OF THAT AS FAS
PART OF OUR HIV PORTFOLIO
DOESN'T HAVE TO JUST STAY
FINITE, WE ARE NOT THE ENTIRETY
OF IT.
WE CAN PARTNER WITH OTHERS TO DO
THAT, AS WELL AS TO ADDRESS SOME
OF THESE WHERE YOU SAY WE'VE
MADE SO MANY SUCCESS, IT SHOULD
BE REDISTRIBUTED, NOT
NECESSARILY.
IT COULD ALSO BE A BETTER
ARTICULATION OF WHAT OUR
PRIORITIES ARE AND WHAT WE'RE
DOING AND HOW WE'RE PARTNERING
WITH OTHERS, AND WE ARE TAKING
THAT INTO CONSIDERATION AS WE
DEVELOP THE STRATEGIC PLAN.
>> I ALSO WANTED TO MENTION
BRIEFLY TOO ABOUT THE REVIEW
CYCLE AND HOW HIV HAS A SEPARATE
REVIEW CYCLE.
I DO FEEL THERE IS SOME -- I
WANT TO SAY JEALOUSY FROM PEOPLE
WHO ARE NOT APPLYING TO THE HIV
CYCLE ON THE STREAMLINE PROCESS
WHERE YOU GET REVIEWED WITHIN
FOUR OR FIVE MONTHS, FUNDING
DECISIONS COULD BE MADE
RELATIVELY QUICKLY, AND I'M JUST
WONDERING, IS THERE A PLAN TO
EXPAND THAT OUTSIDE AIDS
RESEARCH CLEARLY CAN BE DONE IN
THE SETTING OF THE AIDS RESEARCH
CYCLE AND WHETHER STREAMLINING
OTHER PARTS OF THE NIAID TO DO A
SIMILAR TYPE OF PROCESS PROCESO
ADDRESS SOME OF THE CONCERNS
THAT SOME OF THESE PEOPLE MAY BE
FEELING WHO ARE OUTSIDE OF THE
HIV RESEARCH.
>> I DON'T MEAN TO BUST YOUR
BUBBLE THERE, TIM.
BUT THERE'S BEEN AN ONGOING
PRESSURE FROM THE AIDS COMMUNITY
TO TAKE WHAT WE DO AND
STREAMLINE IT ACROSS THE
INSTITUTES FOR ALL RESEARCH.
THE PUSHBACK IS TAKE THE
AIDS-RELATED REVIEW AWAY AND
FOLD US INTO THE EXISTING
STRUCTURES.
THAT HAS BEEN TRIED A COUPLE OF
TIMES, AND ONE OF THE GREAT
THINGS ABOUT THE HIV RESEARCH
COMMUNITY IS YOU TAKE THEM OFF
AND THEY GET REALLY AGGRESSIVE.
AND WE'VE BEEN ABLE TO BEAT IT
DOWN EVERY TIME IT'S COME UP.
SO CONTINUE TO HOLD THE THOUGHT
THAT -- I MEAN, IF YOU THINK
ABOUT BACK IN THE DAY, LIKE WHEN
I WROTE MY FIRST GRANT, I GOT --
I HAD TO MAIL IT IN, I GOT A
PIECE OF PAPERBACK CALLED A PINK
SHEET BECAUSE IT WAS PRINTED ON
PINK PAPER.
ALL OF US HAVE LIVED THROUGH
THAT.
AND IT TOOK TIME TO MAKE THESE
AND YOU NEEDED THAT TIME.
BUT WITH COMPUTERS AND
EVERYTHING ELSE, EVERYTHING HAS
BEEN SHRUNK, AND THERE'S NO --
I'M GOING TO GO OUT ON A LIMB
HERE AND AS A PERSONAL OPINION,
NOT AS DIRECTOR OF DAIDS,
THERE'S NO REASON WE CAN'T GO TO
THREE YEAR SEAT DATES A YEAR
ACROSS THE NIH.
BUT I DON'T THINK THAT VIEW IS
WIDELY HELD IN THE OFFICE OF
EXTRAMURAL RESEARCH OR AT CSR.
I'LL JUST LEAVE IT AT THAT.
>> SO JUST TO BE CLEAR, I WAS
NOT ARGUING AGAINST THE HIV/AIDS
DEADLINE.
I WAS SORT OF JUST ASKING ABOUT
THE -- I THINK IT'S INCREASED
COLLABORATION WHERE PEOPLE
POTENTIALLY HAVE INCORPORATED
HIF IHIV INTO THEIR GRANT.
SO I'M FOR IT, I WAS NOT
SPEAKING AGAINST IT.
>> SO IN ADDITION -- BY THE WAY,
THANK YOU.
THOSE ARE ACTUALLY EXCELLENT
QUESTIONS AND DISCUSSION POINTS.
SO THE FINAL TOPIC THAT REALLY
CAME UP AS A LARGE SYNOPSIS IS
ADDRESSING HEALTH DISPARITIES,
INCLUSION, WOMEN'S HEALTH AND
GLOBAL HEALTH.
AND WE RECEIVED A NUMBER OF
DIFFERENT RESPONSES HERE LOOKING
AT SPECIFICALLY PARTICULAR
POPULATIONS, PREGNANT PEOPLE,
BREASTFEEDING POPULATIONS,
MATERNAL HEALTH, NEONATES, WE
TOUCHED ON THAT EARLIER,
INFANTS, CHILDREN, ADD LESSONS,
ADDRESSING HIV IN CERTAIN
POPULATIONS, MAKING SURE THERE'S
INCLUSION IN THE STUDIES THAT
WE'RE DOING.
IN ADDITION TO ADDRESSING
WOMEN'S HEALTH, WHICH INCLUDES
STIGMA, AND ENSURING ACCESS TO
TREATMENT AND EFFICACY.
IN ADDITION, OBVIOUSLY WE HAVE
AN ENTIRELY SEPARATE
CROSS-CUTTING THEME ON GLOBAL
HEALTH, SO THAT WILL BE A LOT
OF -- SOME OF THIS WILL I
ADDRESSEI BEADDRESSED IN THERE ,
UPTAKE BARRIERS ESPECIALLY IN
LMICs AND UNDERSERVED
POPULATIONS.
ANY QUESTIONS ON THIS SLIDE?
MORE COMMENTS?
OKAY.
WITH THAT, AND AS I MENTIONED,
THIS IS WHERE I WAS GOING TO
KIND OF GET TO THE PUNCH LINE OF
WHAT WE DO WITH THESE THINGS.
ESSENTIALLY, SO RIGHT NOW WE'RE
IN THE PROCESS OF BOTH PUTTING
THE PLAN TOGETHER, ORGANIZING IT
WITH OUR PROGRAM STAFF AS WELL
AS TAKING A LOOK AT THE RFI
RESPONSES AND INCORPORATING IT
WHERE APPROPRIATE.
AS I MENTIONED, THAT IS LEFT, I
WOULD SAY, SPECIFICALLY NEBULOUS
BECAUSE WHAT WE DO NEXT WITH
THIS REALLY VARIES ON -- IT
COULD EITHER COME DOWN TO
INCLUDING IT AS SOMETHING THAT
WE THINK WOULD BE RELEVANT OR
PERHAPS JUST BETTER ARTICULATING
WHAT WE'RE ALREADY DOING OR HOW
WE CAN BETTER COLLABORATE TO
ANSWER SOME OF THESE QUESTIONS,
EVEN IF THEY'RE NOT SPECIFICALLY
IN OUR SWIM LANE OR IN OUR
PURVIEW.
I THINK AS AN INSTITUTE, ONE OF
THE OPPORTUNITIES OF THE
STRATEGIC PLAN IS TO REALLY
BETTER ORGANIZE OURSELVES AND
BETTER ARTICULATE ESSENTIALLY
WHAT WE DO AND IN ADDITION THEN
HOW WE CAN PARTNER WITH OTHERS
TO THEN ADDRESS THE ISSUES AS A
WHOLE.
I SHOULD ALSO MENTION THAT THE
ENTIRETY OF THE RFI RESULTS WILL
ALSO BE INCLUDED AS PART OF THE
PLAN PUBLICATION, WE'LL BE DOING
A SUMMARY OF THE RESULTS THERE.
CARL ALREADY SHOWED THIS SLIDE,
BUT WHERE WE ARE RIGHT NOW IS
THAT MY TEAM IS WORKING ON
DRAFTING THE PLAN AND WORKING TO
INCORPORATE EVERYTHING.
THE GOAL IS TO HOPEFULLY PUBLISH
EARLY NEXT YEAR.
SO WITH THAT, I WILL SAY THANK
YOU FOR YOUR TIME AND ASK IF
THERE ARE ANY QUESTIONS.
>> I'D LIKE TO GO ALL THE WAY
BACK TO THE VERY BEGINNING OF
YOUR TALK.
SO YOU START OFF I THINK WITH
ACTUALLY THAT VERY LAST SLIDE
AND THE PROCESS GOING THROUGH
THIS, AND ON ONE OF THE SLIDES
YOU SHOWED SECOND OR THIRD, WAS
THE 2017 PLAN.
>> YES.
>> SO I WONDER IF PART OF THIS
ENTIRE PROCESS IS ACTUALLY JUST
GOING TO THE '17 PLAN AND SAYING
HOW DID WE DO ON THAT, MEETING
OUR GOALS, WERE THERE THINGS IN
HERE THAT WERE USEFUL TO US,
WERE THERE THINGS THAT WERE --
DID THIS REALLY HELP US BECAUSE
IT SEEMS LIKE THERE'S NO BETTER
MODEL FOR FINDING WHAT WORKS AND
DOESN'T WORK IN MAKING A
STRATEGIC PLAN IS WHAT HAPPENED
BEFORE.
SO IS THAT PART OF IT?
>> ABSOLUTELY.
THAT WAS OUR FIRST STEP.
STEP ONE WAS REVISITING THE
2017 -- AND ACTUALLY I
APPRECIATE YOU SAYING THAT.
STEP ONE, IT TOOK ACTUALLY A
COUPLE MONTHS TO EVEN GET THE
INITIAL SKELETON DRAFT WHICH WAS
REVIEWING OUR PREVIOUS EFFORTS,
IN ADDITION REVIEWING OTHER
INSTITUTES, TO TAKE AS FAR AS A
STRUCTURAL IS CONCERNED AND AS
WELL AS LOOKING AT OAR, MAKING
SURE WE'RE IN ALIGNMENT WITH A
WHOLE BUNCH OF OTHER STRATEGIC
PLANS ACROSS THE INSTITUTE, BUT
YOU'RE ABSOLUTELY RIGHT, STEP
ONE WAS TAKING A LOOK AT THE
FIRST STRATEGIC PLAN, WORKING
THROUGH THAT AND SEEING HOW THAT
WAS ORGANIZED, AND AGREED,
TAKING A LOOK AT EITHER
SUCCESSES THERE OR WHERE WE
BUILD ON, ABSOLUTELY.
>> ARE THERE ANY SPECIFIC
EXAMPLES OF WHAT WORKED OR
THINGS WE DID?
I MEAN, DID YOU CALL OUT -- I
REALLY DON'T REMEMBER, DID YOU
CALL OUT LONG-ACTING
IMPLANTABLES?
I ACTUALLY THINK THAT JUST
ENCOURAGES THE FIELD QUITE
FRANKLY SAYING WE SET UP A GOAL
FIVE YEARS AGO AND IT WORKED.
>> WE DEFINITELY CALLED OUT
LONG-ACTING FOR TREATMENT AND
PREVENTION.
WE ALSO SAID BY 2024-2025, WE'D
HAVE A CURE THAT IN A
SIGNIFICANT AMOUNT OF POPULATION
WOULD BE PRETTY FUNCTIONAL.
NOT THERE.
AND WE'D HAVE A VACCINE THAT WAS
AT LEAST 60 TO 70% EFFECTIVE.
SO YOU HAVE TO TAKE BIG SWINGS,
AND THAT'S THE KIND OF THING
THAT WE DID.
ADDITIONALLY, ON THE TREATMENT
ACROSS THE LIFESPAN, EARLY IN
THE PLAN, WE TALKED ABOUT THE
NEED TO GET THE BEST APT
ANTIRETROVIRALS APPROVED FOR
ACROSS THE LI LIFESPAN.
THAT'S AN AREA THAT IMPAACT
NETWORK HAS EXCELLED WITH AND
WILL CONTINUE TO DO SO.
SO I WOULD SAY IF WE'RE BATTING
BETWEEN 4- AND 500, SO IN
BASEBALL, THAT'S PRETTY GOOD.
IN LIFE, IT'S NOT GOOD ENOUGH.
SO AGAIN, MANY OF THESE RESEARCH
QUESTIONS ARE -- THERE'S SO MUCH
INUNKNOWN THAT WE STILL NEED,
AND THAT'S WHY WE NEED TO BE
ABLE TO CONTINUE TO SUPPORT THE
BASIC SCIENCE.
>> REUBEN.
>> SUPER.
LOTS TO UNPACK AND DISCUSS
THERE.
2017, THAT WAS PREPANDEMIC, SO
WAS THERE ANYTHING IN THIS ON
PANDEMIC PREPAREDNESS?
I THINK OUR VIEWS ON THAT HAVE
CHANGED CONSIDERABLY, SINCE
2017.
I DIDN'T SEE THAT WORD IN THERE
REALLY.
>> IT WAS BIOPREPAREDNESS IS THE
FIFTH PRIORITY.
WE DID THAT BECAUSE IT BOTH
INCLUDES BIODEFENSE AND ACADEMIC
PREPAREDNESS, JUST FROM A
LOGISTICAL STANDPOINT, THEY MADE
SENSE BECAUSE OF THE NATURE AND
OVERLAP OF THEM, BUT PANDEMIC
PREPAREDNESS IS A SPECIFIC FACET
AND ALMOST AN ENTIRE PRIORITY OF
ITS OWN.
>> SO I WANT TO MAYBE CHALLENGE
THE GROUP A LITTLE BIT TOO.
I THINK EVERYONE HERE PROBABLY
WOULD SUPPORT DARWINIAN
EVOLUTION, YOU KNOW AND THE
FITTEST SURVIVE.
WAS I NOT LOUD ENOUGH?
EVERYONE HERE MIGHT SUPPORT
DARWINIAN EVOLUTION AND WE SEE
RAPIDLY EVOLVING VIRUSES AND
RESISTANCE AND THINGS LIKE THAT.
SO I THINK WITHIN HIV RESEARCH,
THERE'S TREMENDOUS ADVANCES AND
COLLABORATIONS, I THINK RICH WAS
REFERRING TO THINGS LIKE THAT
WHERE WE DO WORK ACROSS AND
COLLABORATE REALLY, REALLY WELL,
BUT WHAT IF WE JUST LET EVERYONE
COLLABORATE ON DIFFERENT
PROBLEMS AND MAYBE MORE NEW
PEOPLE WOULD COME TO THE FIELD
AND MORE OF THESE HARD PROBLEMS
LIKE VACCINE WOULD GET SOLVED OR
CURE, RIGHT?
IN WHICH CASE THERE WOULDN'T BE
ANYTHING PROTECTED AND IT WOULD
JUST OPEN UP FOR ALL BASIC
SCIENTISTS TO GO AFTER THESE
PROBLEMS AND THEN MAYBE THERE
WOULD BE MORE INNOVATIVE THINGS
TO TRANSLATE.
SO WHAT'S STOP WHAT
>> SO WHAT'S STOPPING SOMEBODY
FROM WORKING, PUTTING A GRANT
IN?
IT'S NOT JUST WHAT YOU CHOOSE TO
WORK ON.
>> SO WITH SUCH A LARGE
PROPORTION WORKING ON ONE VIRUS,
THERE'S A LOT LESS WORKING ON
OTHERS.
WE'VE SIEB SCENE ALL THE
INNOVATION COME OUT OF HIV THAT
WE MIGHT NOT HAVE ACHIEVED HAD
THERE NOT BEEN THAT DEDICATED
EVERYTHING.
BUT IF IT WAS AN EQUALLY
DEDICATED EFFORT ON OTHER VIRUS,
THERE COULD BE OTHER SURPRISE
THERE IS THAT COULD COME BACK
AND HELP ON HIV RESEARCH.
JUST A THOUGHT.
>> AGAIN, WHAT IS -- BACK TO
SWIM LANES, WHAT IS THE
RESPONSIBILITY OF DAIDS, WHAT IS
THE RESPONSIBILITY OF DMID,
TALKING ABOUT A LURE KNOWLEDGE
CAL VIRUS, WHAT'S THE
RESPONSIBILITY OF NINDS?
I THINK PART OF THE PROBLEM IS
THAT WE ARE DRIVEN BY THE WAY
THE FUNDS ARE APPROPRIATED BY
THE CONGRESS.
AND TO A CERTAIN EXTENT, THAT
LIMITS THE DEGRIE DEGREE OF
FLEXIBILITY.
AND THAT'S ONE OF THE REASONS WE
PUSH VERY HARD TO EXPAND THE
DEFINITION OF CO-MORBID ITS AND
COINFECTIONS, BECAUSE THAT'S A
WAY TO BLOW SOME OF THAT OPEN.
>> I TOTALLY AGREE WITH THAT,
AND THAT'S THE TRICKY PART THAT
I DON'T HAVE A SOLUTION TO.
>> I JUST WANTED TO COMMENT THAT
I THINK ONE OF THE OTHER -- ONE
OF THE CHALLENGES IS THAT IN
THIS MOMENT, THERE IS SO MUCH
UNCERTAINTY ABOUT THE FUTURE AND
THE BUDGETS, THE FACT THAT THE
BUDGETS ARE SO TIGHT, I THINK
THAT DRIVES SOME COMMENTS LIKE
THESE.
SO I'M SURE THIS IS SOMETHING
EVERYBODY IN THIS ROOM FULLY IS
AWARE OF, IF THERE WAS REALLY
ENOUGH MONEY IN THIS COUNTRY TO
FUND ALL OF THE BIOMEDICAL
RESEARCH THAT NEEDED TO BE DONE,
THEN WE WOULDN'T BE HAVING THIS
CONVERSATION AT ALL.
THERE JUST ISN'T.
SO IT DOESN'T MEAN THAT YOU
LEVEL DOWN, RIGHT?
IT THEANS -- AND WE ALL HAVE TO
VOTE.
>> WHEN YOU SEND OUT AN RFI,
YOU'RE GOING TO GET RESPONSES
FROM DIFFERENT PEOPLE WITH
DIFFERENT PURVIEW AND DIFFERENT
ADVOCACY GROUPS AND THINGS LIKE
THAT.
AND A LOT OF CASES THEY WENT
RIGHT DOWN THE LINE AND
RESPONDED TO EACH PRIORITY
INDIVIDUALLY.
SO IF YOU WERE NOT AN HIV/AIDS
RESEARCHER AND YOU GET TO THE
HIV/AIDS PRIORITY, YOUR COMMENTS
ARE PROBABLY GOING TO BE GEARED
MORE TOWARDS SPREADING THE
WEALTH AND SHARING THOSE
RESOURCES WITH SOMEONE WITH YOUR
AREA OF INTEREST.
AND I MEAN, THAT IS PART OF
THEIR INTEREST TO DO SO.
HOWEVER, YOU KNOW, IN AN EFFORT
OF TRANSPARENCY TO SHARE THAT
WITH YOU, THAT IS ALSO PART OF
THE PROCESS WHEN YOU GET THESE
RFIs TO ALSO UNDERSTAND, WHICH
IS ONE OF THE REASONS WHY I
TRIED TO LAY THAT EARLIER, IS TO
SAY WHEN WE PUT THAT'S OUT,
WRITE DOWN EACH PRIORITY AND
GAVE INPUT ON EVERY SINGLE ONE
OF THEM AS WELL.
>> SO JUST ON THAT POINT, SO I
MEAN, YOU SHOWED THERE WAS ABOUT
63 RESPONDED IN THIS CYCLE.
>> YES.
>> IT SOUNDED LIKE HALF ARE
HIV-RELATED.
>> THAT'S ANOTHER GOOD POINT,
THE RESPONSES EITHER TOUCHED ON
IT --
>> THE 2017 TIMELINE, WHAT WERE
THE NUMBERS --
>> I'M NOT SURE THERE WAS AN RFI
ON THAT ONE AT THE TIME.
I DO NOT BELIEVE WE DID THIS PRO
SET PROCESS.
>> JUST A COMMENT, KUDOS FOR
DOING THIS PROCESS.
I EL
>> OBVIOUSLY WE'RE NOT ALL GOING
TO AGREE WITH EVERYTHING WE --
>> THANK YOU VERY MUCH, AND
THANK YOU ALL FOR YOUR COMMENTS.
>> THANK YOU VERY MUCH.
OKAY.
CARL IS GOING TO STEP BACK TO
THE FRONT AND TALK ABOUT FUTURE
DIRECTION OF THE CLINICAL TRIALS
NETWORKS.
>> I'M GOING TO TAKE A LITTLE
BIT LONGER WITH A LITTLE BIT
MORE GRANULARITY THAN I NORMALLY
DO.
AND I THINK IT'S IMPORTANT IN
PART BASED ON THE WAY WE'VE BEEN
THINKING ABOUT THIS, BUT ALSO
YOU'LL SEE A LOT OF THIS
PREVIOUS CONVERSATION ABOUT
COLLABORATION AND FUTURE
DIRECTIONS REFLECTED IN THE
SLIDES TODAY.
THIS IS ORGANIZED NOT BY
NETWORK.
I DO NOT HAVE A BUCKET THAT SAYS
IMPACT, A BUCKET THAT SAYS ACTG,
OR PTN OR VTN.
IT IS ORGANIZED BY FUNCTIONAL
RESEARCH AREAS.
SO WHEN I SAY THINGS LIKE
GETTING THE BEST ANTIRETROVIRALS
ACROSS THE LIFESPAN, THE PEOPLE
AT IMPACT, THEY'RE JUST GOING TO
HAVE TO TRUST ME.
AND TALK ABOUT CURE ACROSS THE
LIFESPAN, IT NEEDS TO BE
REFLECTED THAT YOU'RE NOT GOING
TO SEE INDIVIDUAL NETWORKS
NECESSARILY CALLED OUT.
WITH THAT SAID, WE ARE IN A
PROCESS SIMILAR TO A STRATEGIC
PLAN WHERE EVERY SEVEN YEARS, WE
COMPETITIVELY REVIEW THE NETWORK
ACTIVITIES.
WE ARE LITERALLY HALFWAY THROUGH
THE SEVEN-YEAR GRANT CYCLE.
SO WHAT WE ARE DOING IS TAKING A
PAUSE, LOOKING AT WHERE WE ARE
AS A RESEARCH ENTERPRISE, WHERE
WE ARE WITH OUR FUNDING, AND
THINKING ABOUT WAYS WE COULD BE
BETTER.
WHERE DO WE NEED TO BE?
NOT NECESSARILY WHEN WE MAKE THE
NEXT SET OF AWARDS, BUT CAN WE
THINK ABOUT A VERY
FORWARD-LOOKING AGENDA THAT GETS
US TO WHERE WE ARE THINKING AS A
GROUP OF SCIENTISTS, WHERE WE
WANT THE CLINICAL RESEARCH THAT
WE ARE SEEKING TO DRIVE, TO
CARRY US THROUGH TO THE NEXT
NETWORK RENEWAL IN 2034.
SO A 10-YEAR CYCLE.
THREE YEARS LEFT IN THIS CYCLE,
SEVEN IN THE NEXT.
SO WE'RE GOING TO BE FIVE YEARS
BEYOND THE NIAID STRATEGIC PLAN.
SO WHERE WE ARE IN THE PROCESS
IS WE ARE IN PLANNING MODE NOW
AND THROUGH PART OF 2025.
IN 2026, COMPLETION, IN 2027 WE
WILL MAKE AWARDS, AND IN THIS
PERIOD BETWEEN NOW AND THE TIME
OF AWARDS, WE HAVE THE
FLEXIBILITY TO ADAPT, TAKE NEW
IDEAS AND REALLY MAKE SURE THAT
WE ARE PUTTING FORWARD THE MOST
SORT OF VISIONARY PATH FOR US
AND THE ACTIVITY THAT WE ARE
SEEKING TO FOSTER TO IMPROVE THE
LIFE OF PEOPLE LIVING WITH HIV
AND IMPROVE PREVENTION OF HIV
FOR ALL.
SO WHERE WE ARE, WE'RE NOW IN
THE AREA OF -- WE LAUNCHED IN
THE SPRING WITH A STRATEGIC
WORKING GROUP MEETING WHERE ALL
THE NETWORKS CAME IN AND WERE
ABLE TO BASICALLY MAKE A
PRESENTATION THAT WAS PRETTY
DETAILED ABOUT WHERE THEY
THOUGHT THEIR RESEARCH AGENDA
SHOULD GO.
SO THAT GAVE US A BASELINE.
OVER THE SUMMER, UNTIL DECEMBER,
WE WILL CONTINUE TO GET INPUT
FROM STAKEHOLDERS, INVESTIGATORS
COMMUNITY.
WE'VE HAD WEBINARS, WE ARE IN
THE PROCESS OF DEVELOPING BLOG
POSTS ON SPECIFIC TOPICS,
THEMATIC DISCUSSION DISCUSSIONSN
FEEDBACK.
TOWN HALLS MAY BE NECESSARY.
TODAY WE ARE HERE FOR A
PRELIMINARY DISCUSSION ABOUT
IDEAS THAT WE HAVE, AND WE WILL
CONTINUE TO DO THIS WITH OTHER
ADVISORY COMMITTEES, AND WE GET
TO JANUARY, WE WILL COME BACK
WITH MORE OF A FINAL STRUCTURE.
SO FOR TODAY, THIS IS THE
PRELIMINARY DISCUSSION WITH
ARAC.
SO WE HAVE A WEBSITE THAT'S UP
THAT IS GOING TO BECOME THE HOME
OF ALL THE BLOG POST, THE HOME
OF THE FEEDBACK WE'VE RECEIVED,
AND ALSO THERE WILL BE A PLACE
WHERE PEOPLE CAN WRITE DIRECTLY
WITH ADDITIONAL COMMENTS AND
IDEAS THEY WILL BE MONITORED AND
READ.
WHAT WE WOULD PLAN TO DO WITH
THE FEEDBACK AND THE COMMENTS
THAT WE GET, WHETHER IT'S IN A
WEBINAR OR THROUGH THE WEBSITE,
IS DEVELOP A SERIES OF FAQs.
BECAUSE THERE ARE THEMES THAT
EMERGE WHEN YOU LOOK AT THE
TOTALITY OF THE DATA.
CAN WE THEN BUNDLE THESE AND
GIVE A RESPONSE TO KEEP THE
DIALOGUE GOING WITH PEOPLE THAT
ARE INTERESTED IN PROVIDING
FEEDBACK.
SO THAT'S WHERE WE'RE AT TODAY
IN TERMS OF CONTINUING TO
SOLICIT OUTREACH FOR
STAKEHOLDERS.
HERE ARE THE TWO MOST RECENT
ONES WE'VE HAD.
WE HAD ONE FOCUSED SPECIFICALLY
ON SCIENTIFIC PRIORITIES IN MAY,
WITH COMMUNITY AND STAKEHOLDER
INPUT, AND THEN JUST LAST WEEK,
WE HAD ONE ON THE STRUCTURE AND
FUNCTION OF CTUs AND CRSs.
A LOT OF DISCUSSION ABOUT
IMPLEMENTATION SCIENCE AND HOW
TO FOSTER THE RIGHT TYPE OF
SITES TO ENGAGE IN
IMPLEMENTATION SCIENCE.
HANK IS PROVING TO INCREDIBLY
VALUABLE AS A CONVENING GROUP,
HANC, BECAUSE THEY HAVE A DEGREE
OF RECOGNITION IN COMMUNITY FOR
THESE KINDS OF THINGS.
WE'RE ALSO MORE THAN HAPPY TO
COME TALK TO INDIVIDUAL GROUPS
AND ORGANIZATIONS.
I'VE BEEN SCHEDULED INTO EVERY
NETWORK MEETING TO COME IN AND
TALK ABOUT THE STRATEGIC VIEW
ABOUT WHERE WE'RE GOING.
IMPACT IS AT THE END OF THE
MONTH.
SO AS WE THINK ABOUT THIS, IN
ADDITION TO BEING WITH STRATEGIC
ABOUT WHERE WE WANT TO GO, WHAT
DO WE NEED TO FOCUS ON AS
SCIENTIFIC LEADERS THAT WE CAN
ACCOMPLISH IN THE REMAINDER OF
THIS CURRENT GRANT CYCLE?
WHERE ARE THE OPPORTUNITIES THAT
HAVE EMERGED THAT ARE MAYBE NOT
BIG ENOUGH TO BECOME AN ELEMENT
IN THE NEW AWARD BUT WHERE WE
CAN MAKE GAINS.
WHAT ADJUSTMENTS DO WE NEED TO
MAKE IN THE STRUCTURE AND
SCIENTIFIC DIRECTION NOW AND
THROUGH THE NEW AWARDS THAT WILL
HELP ACCELERATE THE PACE OF
DISCOVERY, AND HOW DO WE WORK TO
BUILD IMPLEMENTATION SCIENCE
NEEDS AND RESEARCH INTO OUR
IMPLEMENTATION INTO OUR PLANS?
SO I'LL JUST GO BACK AND SAY
THERE'S AN OVERALL THEME THAT
WILL EMERGE FROM THE PREAN
TAITION.
FROM THE
PRESENTATION TODAY AND IT COMES
DOWN TO EXPANDED COLLABORATIONS.
WHAT YOU SAW FROM WHAT NICHOLAS
PRESENTED IS THERE IS A NEED TO
BE SIGNIFICANTLY MORE
INTERDISCIPLINARY THAN WE
CURRENTLY ARE.
WE HAVE WORKED VERY HARD TO
BUILD RELATIONSHIPS WITH
INSTITUTES.
SOME ARE VERY RECEPTIVE TO THOSE
OPPORTUNITIES, AND SOME ARE
RELATIVELY RESISTANT.
AS YOU'VE SEEN TODAY IN MY
PRESENTATION AND WITH DR. --
WHAT DR. MARAZZTSO SHOWED,
THERE'S NEW LEADERSHIP COMING IN
TO THE OFFICE OF AIDS RESEARCH
AND THERE'S NEW LEADERSHIP
ACROSS THE NIH WITH DR. MONICA
BERTAGNOLLI.
SO WE ARE GOING TO WORK
EXTREMELY HARD AT HELPING TO
CREATE BETTER OPPORTUNITIES TO
BUILD THOSE KINDS OF BRIDGES SO
WE'RE NOT TAKING THE MONEY AND
SHIFTING IT OFF TO SOMETHING
THAT IS NOT RELEVANT TO US BUT
CAN WE BRING IN THE EXPERTISE,
BECAUSE WE'RE NOT CARDIOLOGISTS,
WE'RE NOT EXPERTS IN KIDNEY
DISEASE OR LIVER DISEASE, BUT
WHAT WE NEED IS THE EXPERTISE TO
HELP US DEAL WITH THE
COINFECTIONS AND COMORBIDITIES
ASSOCIATED WITH HIV,
PARTICULARLY THE COMORBIDITIES.
THE BEST EXAMPLE OF THAT THAT
WILL WE'VE BEEN QUITE SUCCESSFUL
WITH IS THE REPRIEVE TRIAL, BUT
THAT WAS NOT EASY.
THAT REQUIRED THE GROUP TO WRITE
A GRANT.
ART WAS A PARTNER.
WE GOT TO A GOOD PLACE, BUT IT
TOOK A TREMENDOUS AMOUNT OF
ENERGY AND EFFORT TO GET US TO
WHERE WE ENDED UP.
THAT SAID, THERE WAS SUCCESS AND
CAN WE BUILD ON SUCCESS BUT USE
ALTERNATIVE MODELS TO GET THOSE
KINDS OF IDEAS BUILT AND BOUGHT
INTO AT THE MULTI-INSTITUTE
LEVEL SO THAT WE CAN MOVE OUR
IDEAS FORWARD.
SO YOU ALL KNOW THE NETWORK
STRUCTURE.
THAT'S WHAT WE HAVE RIGHT NOW,
FOUR LEADERSHIP GROUPS
ASSOCIATED WITH THE GREEN,
LEADERSHIP AND OPERATIONS
CENTER, EACH HAS ASSOCIATED DATA
CENTER AND STATISTICAL CENTER.
THERE'S LAB CENTERS.
BUT IN ADDITION TO THAT, YOU ARE
PROBABLY AWARE THAT THERE IS
NETWORK OVERSIGHT ACTIVITIES.
THERE'S ALSO COMMUNITY
ENGAGEMENT EFFORTS THAT ARE
ONGOING.
AND THEN THERE'S NETWORK
COORDINATION ACROSS THE TOP.
THE CTUs AND CRSs ARE THERE
SHOWN AT THE BOTTOM.
SO IN TERMS OF THE CURRENT
APPROACH TO SITE INSIGHT
OVERSIGHT, THERE'S ESSENTIALLY
THREE FLAVORS OF CRSs OF
CLINICAL RESEARCH SITES THAT ARE
EITHER ASSOCIATED OR NOT
ASSOCIATED WITH THE CLINICAL
TRIALS UNIT.
SO IN SOME WAYS IF YOU THINK OF
A MOTHERSHIP, A CLINICAL TRIALS
UNIT IS THE MOTHERSHIP, IT
PROVIDES ADMINISTRATIVE
CAPACITY, SHARED RESOURCES,
MENTORING AND OVERSIGHT, AND
THERE ARE PLENTY OF CRSs/C
TUs THAT HAVE AFFILIATED
CLINICAL RESEARCH SITES THAT ARE
ALIGNED WITH THEM AND EACH ONE
CAN MAKE SCIENTIFIC
CONTRIBUTIONS IN IMPLEMENT
TRIALS AND MANY ARE ALIGNED WITH
SPECIFIC NETWORK AND NETWORK
ACTIVITIES.
WE ALSO HAVE THE ABILITY TO
BRING IN PROTOCOL-SPECIFIC SITES
IF WE DO NOT HAVE THE CAPACITY
OR THE EXPERTISE AT THE CURRENT
SITES TO PERFORM THE RESEARCH
THAT IS PUT FORWARD THROUGH THE
CLINICAL TRIAL THAT THE NETWORK
IS PROVIDING.
THIRD, THERE'S ALSO THE ABILITY
TO BRING IN TRULY
PROTOCOL-SPECIFIC SITES AS SHORT
TERM IMPLEMENTERS.
WE SEE A COMBINATION OF THESE
TYPES OF SITES, CRS, PROTOCOL
SPECIFIC SITES ASSOCIATED WITH
CTUs, AS WELL AS
PROTOCOL-SPECIFIC SITES THAT ARE
BRAND NEW AS BEING ESSENTIAL
TOOLS THAT WE CAN MIX AND MATCH
AS WE MOVE FORWARD FOR
IMPLEMENTATION SCIENCE.
FOR EXAMPLE, THERE'S A PTN
PROTOCOL CALLED 096 WHICH IS
LOOKING AT ACCESS TO
ANTIRETROVIRALS UP TAKE FOR ART
AND PREVENTION METHODOLOGIES IN
THE SOUTH.
THERE'S NOT A SINK EL SITE THAT
IS ASSOCIATED WITH THE NETWORK
FACILITY, THEY'RE ALL IN CLINICS
IN CITIES.
SO THIS IS A BIG DEPARTURE, AND
THOSE WOULD BE EXAMPLES OF
PROTOCOL-SPECIFIC SITES.
WE HAVE A PROTOCOL WORKING IN
BARBERSHOPS.
YOU WOULDN'T SEE A BARBER SHOP
AFFILIATED WITH A CTU, BUT IF
YOU'RE GOING TO REACH COMMUNITY,
YOU'RE GOING TO NEED TO GO TO
PLACES WHERE COMMUNITY
CONGREGATES AND WE'RE GOING TO
NEED TO BE FLEXIBLE ABOUT BEING
ABLE TO ADD THOSE KINDS OF
PROTOCOL-SPECIFIC SITES.
SO TO STATE THE OBVIOUS, WE ARE
GOING TO MAINTAIN THE FOUR
LEADERSHIP GROUPS.
THE OVERARCHING THEMES OF THIS
RENEWAL WILL BE INNOVATION AND
COLLABORATION.
THE INNOVATION CAN COME IN AS WE
MOVE FORWARD, WHAT ARE THE
PRODUCTS WE'RE BRINGING IN?
THAT'S A FORM OF INNOVATION.
BUT ANOTHER WAY OF THINKING
ABOUT INNOVATION IS CLINICAL
TRIAL DESIGN.
WE REALLY HAVE TO SOLVE THE
QUESTIONS ABOUT ACTIVE
COMPARATOR GROUPS, THE NOTION OF
WHEN IS A PLACEBO REASONABLE AND
ETHICAL, BUT THIS ALL WILL NEED
TO BE WORKED OUT IN A WAY THAT
FACILITATE THE RESEARCH AND
DOESN'T MAKE IT SO EVERY TRIAL
WE DO THAT REQUIRES AN ACTIVE
CONTROL ARM REQUIRES 60,000
PARTICIPANTS.
I THINK THAT'S THE CHALLENGE WE
FACE AS WE MOVE FORWARD.
IN THE PAST CYCLE WE'RE
COMPLETING, WE'RE PARTWAY
THROUGH NOW, WE'RE SEEING MANY
GROUNDBREAKING STUDIES THAT
STARTED FROM THESE DLAB RANGE OF
MOTIONS WITH OTHER NETWORKS.
OTHER NETWORKS AND OTHER PARTS
OF NIH.
SO I THINK THAT WE REALLY NEED
TO HAVE A WAY OF HAVING A BETTER
DIALOGUE ACROSS THE NIH ON THE
RESEARCH THAT IS GOING TO BE
REALLY CRITICAL TO HELP IMPROVE
THE HEALTH OF PEOPLE LIVING WITH
HIV.
SO ACROSS ALL THESE AREAS OF HIV
SCIENCE WE WILL REALLY NEED TO
EXPEDITE COLLABORATION TO
ADDRESS THE HIGHEST PRIORITY
QUESTIONS.
SO I'M GOING TO GO THROUGH A
LITTLE BIT ABOUT EACH OF THESE
AREAS, AND YOU'LL SEE ON SEVERAL
OF THE SLIDES THE NETWORKS THAT
ARE PRIMARILY RESPONSIBLE FOR
THESE AS WE GO FORWARD.
SO FOR HIV PREVENTION, WE WANT
TO CONTINUE TO SUPPORT
BIOMEDICAL RESEARCH ON
PREVENTION INTERVENTIONS THAT
CAN CHANGE THE PRACTICE OF
MEDICINE AND REDUCE HIV
INCIDENCE.
AS BACKGROUND, AS YOU ARE ALL
AWARE, WE HAVE MADE TREMENDOUS
PROGRESS THROUGH ORAL PREP,
THROUGH INJECTABLE PREP, THERE'S
ACTIVITIES AND WORK THAT NEEDS
TO BE DONE WITH POST EXPOSURE
PROPHYLAXIS, AND U EQUALS U HAS
BECOME THE COIN OF THE REALM.
FOR CERTAIN TYPES OF MTPs,
ESPECIALLY ONES RELATED TO
CONTRACEPTION, THERE'S ACTIVITY
HERE THAT WILL BE QUITE
IMPORTANT.
SO IN TERMS OF PARTNERS,
OBVIOUSLY THERE'S COMMUNITY,
WE'VE HAD REALLY GOOD
PARTNERSHIPS WITH THE BILL AND
MELINDA GATES FOUNDATION, OTHER
INSTITUTES AT NIH, AND AS WE
LOOK AT IMPLEMENTATION SCIENCE
MOVING FORWARD, IT IS REALLY
ESSENTIAL THAT WE THINK ABOUT
THE OTHER PART OF THE FEDERAL
GOVERNMENT, WHERE WE CAN BUILD
THESE TYPES OF COLLABORATIONS TO
LOOK AT IMPLEMENTATION.
WITH CDC, WITH HRSA, FOR OPIOID
SUBSTANCE USE AND OTHER FORMS OF
DRUG USE, SAMHSA, PEPFAR AND
USAID WILL BE CRITICAL PARTNERS.
THERE'S ALSO INTERNATIONAL
GOVERNMENTS, PARTNERS WE NEED TO
WORK ON, WORK WITH, AND INDUSTRY
REMAINS AN ESSENTIAL ELEMENT OF
MANY OF THE ACTIVITY THAT WE
ENGAGE IN BECAUSE WE ARE NOT A
DRUG COMPANY.
WE ARE NOT GOING TO GET IN THE
BUSINESS OF MAKING CHEMICALS FOR
USE IN EFFICACY TRIALS OR
PROVING THE CONCEPT THAT A DRUG
WORKS BECAUSE AT THE END OF THE
DAY, THERE HAS TO BE A WAY OF
TAKING THOSE ACTIVE MOLECULES
AND TAKING THEM TO SCALE.
TO A POINT WHERE THEY ARE
ACCESSIBLE AND USABLE BY OTHERS.
I THINK THE PARTNERSHIPS WE'VE
HAD WITH VIV, CABOTEGRAVIR ARE
REALLY GOOD.
THE CHALLENGE WITH THAT STUDY IS
WE FINISHED EARLY, SO WE DID NOT
HAVE THE CHANCE TO FINISH ALL OF
THE NECESSARY DEVELOPMENT STEPS,
BUT WE COULD DO BETTER.
AND IN SOME WAYS, WE'RE MA MAKIG
OUR FIRST AND SOMETIMES SECOND
OR THIRD PANCAKE, BUT AS WE GO
FORWARD, WE WILL ADD THESE
ELEMENTS INTO THE MIX EARLIER IN
THE FUTURE SO WE'RE NOT WAITING
UNTIL WE'RE PARTWAY THROUGH THE
EFFICACY TRIALS TO START
THINKING ABOUT IMPLEMENTATION.
WE TRIED, WE WEREN'T AS
AGGRESSIVE AND AFORCEFUL AS WE
COULD OR SHOULD HAVE BEEN AND I
THINK WE'LL DO BETTER IN THE
FUTURE.
WE REALLY NEED TO ADVANCE NEW
WAYS TO REDUCE VERTICAL
TRANSMISSION, AND TO WHAT I
THINK ABOUT THIS IS A FORM OF
SOME VERY FOCUSED CLINICAL
TRIALS ON NEW STRATEGIES BUT
REALLY INTEGRATED WITH
COORDINATED IMPLEMENTATION
SCIENCE.
SO WE GET THESE IDEAS TO
PREGNANT PEOPLE AS QUICKLY AS
POSSIBLE IN A COORDINATED WAY,
WHERE WE'RE ALSO THINKING ABOUT
PREGNANT PEOPLE LIVING WITH HIV
AND PEOPLE WHO ARE AT RISK OF
HIV SO THAT WE ARE DOING
VIRTUALLY EVERYTHING WE CAN TO
SLOW DOWN, PREVENT VERTICAL
TRANSMISSION.
SO IN ADDITION TO THAT, WE HAVE
TO THINK ABOUT THE INFANTS THAT
ARE BORN THAT ARE PAIR PERINATY
INFECTED.
WE NEED TO BE ABLE TO TAKE
CHILDREN AT THAT TIME AND GET
THEM ON TO ANY RETROVIRAL
THERAPY AND USE A P1115-LIKE
SYSTEM TO ENGAGE IN GETTING
THOSE BABIES ON THERAPY AS
QUICKLY AS POSSIBLE SO THAT WE
ARE DOING EVERYTHING WE CAN TO
FURTHER REDUCE DEVELOPMENT OF
AIDS IN THAT POPULATION.
ADDITIONALLY, WE WOULD THEN HAVE
A COHORT THAT WOULD BE ELIGIBLE
TO PARTICIPATE IN CURE STUDIES
IN THE FUTURE, AND THERE'S A LOT
OF EXCITEMENT IN CURE WITH IDEAS
THAT ARE GOING FORWARD.
I SAID EARLIER CHOICE IS A GOAL,
PREVENTION METHODS BEST NEED TO
BE DIRECTED AT VULNERABLE
PREVENTION METHODS BEST NEED TO
BE DIRECTED -- DOMESTICALLY AND
PARTNERSHIP AND THE PARTNERSHIPS
WE BUILD -- IT WILL BE REALLY
IMPORTANT TO HELP UNDERSTAND
UPTAKE AND ADHERENCE AND MAKING
SURE WE ARE LACKING AT EFFICIENT
AND COST-EFFECTIVE DELIVERY
METHODS THAT ARE IMPLEMENTABLE
AND THAT'S WHERE THE
PARTNERSHIPS WITH THE LIKES OF
HRSA, SAMHSA, CDC AND PEPFAR
WILL BE ABSOLUTELY ESSENTIAL.
BECAUSE YOU DON'T WANT AN
ACADEMIC GROUP DOING YOUR
IMPLEMENTATION SCIENCE UNLESS
THEY ARE A PARTNER WITH AN
IMPLEMENTER.
BECAUSE THE IMPLEMENTERS WILL
HAVE TO LIVE WITH WHATEVER WE
PRODUCE, AND I THINK THAT'S WHY
GIVING PEOPLE SKIN IN THE GAME
WILL BE CRITICAL AS WE MOVE
FORWARD IN THAT SPACE.
MOVING ON TO VACCINES THE
DIVISION REMAINS COMMITTED TO
WORKING ON A SAFE, EFFECTIVE AND
DURABLE HIV VACCINE.
WHAT WE ARE SEEKING NOW ARE WAYS
OF DEVELOPING VACCINES THAT CAN
TRIGGER THE PRODUCTION OF BROAD
NEUTRALIZING AND BODIES AS WELL
AS MOVING TOWARDS ENHANCED CELL
MEDIATED RESPONSES THAT WILL
ELIMINATE INFECTED CELLS.
I THINK THE PARTNERSHIP OF THOSE
TWO GOING FORWARD IS ESSENTIAL.
AT THE SAME TIME, YOU SAW TED'S
TALK TODAY, TED PIERSON TALKED
ABOUT THE WORK ON THE FUSION
PEPTIDE.
HE REALLY UNDERSOLD THAT.
THAT STUFF LOOKS REALLY GOOD AND
THAT COMBINED WITH SOME OF THE
THINGS THAT THE LIKES OF BART
AND LEO AT THE HUTCH AND DENNIS
AND HIS TEAM ARE DOING REALLY
GIVES ME HOPE.
NOW I AM ONE OF THE MOST
OPTIMISTIC PEOPLE YOU'LL EVER
MEET.
AND I STILL THINK SAFE EFFECTIVE
AND DI DURABLE HIV VACCINE IS ON
THE HORIZON.
NOT OVER THE HORIZON, ON THE
HORIZON.
SO THE CHALLENGES REMAIN, HOW DO
WE GET A MOLECULE FROM THE LAB
INTO THE ARM.
THIS GETS BACK TO GNP
MANUFACTURING PROCESSES AND WE
DO ENGAGE IN SOME OF THAT FOR A
SCALE RELATED TO PHASE 1 AND 2A
BUT THEN PARTNERSHIPS ARE
ULTIMATELY NEEDED.
WE'RE CURRENTLY WORKING WITH
MODERNA.
WERE WORKING WITH VIR AND THAT'S
A SAD STORY FOR CONVERSATIONS
OVER A BEER.
WE HAVE PARTNERSHIPS WITH THE
VACCINE CENTER, BILL AND MELINDA
GATES, NIH INSTITUTES AND
PHARMACEUTICAL PARTNERS.
BUT REALLY IT IS ABOUT
CONTINUING REALLY STRONG BASIC
SCIENCE SO WE CAN MAKE
ADDITIONAL DISCOVERIES, LIKE
WHAT IS THE STORY WITH CMC IN
DRIVING THE H -- THAT'S A
PLATFORM THAT DOESN'T
NECESSARILY REQUIRE A VIRUS TO
DELIVER THE ANTIGENS.
ADDITIONALLY, WITH REA WE REALLO
EXPAND THE WORK ON VACCINES FOR
OTHER COMORBIDITIES,
PARTICULARLY TUBERCULOSIS, AND
THIS REMAINS A GOAL FOR VACCINE
RESEARCH AS WELL.
MOVING ON TO THERAPEUTICS,
REALLY WHAT WE ARE ABOUT IS
ADVANCING THERAPEUTIC STRATEGIES
TO TREAT HIV AND HIV ASSOCIATED
COINFECTIONS AND COMORBIDITIES
ACROSS THE LIFESPAN.
THERAPEUTICS RESEARCH WILL SEEK
TO PROVIDE TO ALL PEOPLE LIVING
WITH AIDS/HIV MEANS TO ACHIEVE A
HEALTHY LIFESPAN AND A BRIDGE TO
A CURE.
SO WHEN YOU HEAR THE PEOPLE AT
THE ACTG, PARTICULARLY JUDY TALK
ABOUT THIS, SHE TALKS ABOUT THE
FOURTH 95.
AND IF WE THINK ABOUT THE THIRD
95 BEING VIRALLY SUPPRESSED, THE
FOURTH 95 IS LIVING A NORMAL
LIFESPAN WITHOUT COMORBIDITIES,
WITH THE COMORBIDITIES THAT I
SUPPOSE YOU'RE GENETICALLY
PROGRAMMED FOR, IF YOU'RE
PROGRAMMED GENETICALLY FOR HEART
DISEASE, YOU'RE GOING TO GET IT,
BUT WE CAN -- WE NEED TO DEAL
WITH COMORBIDITIES THAT ARE
EXACERBATED BY LIVING WITH HIV.
THAT LAS TO BE OUR TARGET, AND
THAT NEEDS TO BE -- THIS IS
WHERE THE CALL TO THE OTHER
INSTITUTES TO COME AND JOIN US
IN A WAY OF ADDRESSING THESE
DISEASES THAT ARE WITHIN THEIR
PURVIEW, BUT ARE EXACERBATED BY
HIV.
AND THAT PARTNERSHIP DOESN'T
MEAN THAT THEY PAY THE FREIGHT.
IT A PARTNERSHIP WHERE THEY
PROVIDE SCIENTIFIC INPUT, AND WE
CAN THEN PARTNER TO GET THIS
KIND OF WORK DONE.
A GOOD EXAMPLE OF THAT WAS THE
SLIM LIVER STUDY THAT WAS JUST
DONE BY NIAID, WHERE HE TOOK
SEMAGLUTIDE AND TREATED FATTY
LIVER DISEASE AND IT WAS IS KIND
OF MAGICAL HOW IT MELTED THE
FATTY LIVER.
I THINK THOSE KINDS OF
RELATIVELY SMALL BUT IMPACTFUL
TRIALS THAT TOOK FOREVER TO GET
OPEN FOR A VARIETY OF REASONS
WILL CONTINUE TO BE THE KIND OF
TOOLS THAT WE NEED TO SEE HOW
THESE NEW DRUGS THAT HAVE IMPACT
ON METABOLIC PATHWAYS CAN BE
USED IN HIV.
AS WE MOVE FORWARD.
THE PARTNERS AREN'T THAT
DIFFERENT FOR EVERYTHING ELSE WE
DO.
BUT THE INSTITUTES AT NIH WILL
BE ABSOLUTELY CRITICAL AS WE
MOVE FORWARD.
SO IN TERMS OF CHALLENGES AND
FUTURE DIRECTS, WE REALLY NEED
TO BE ABLE TO WORK WITH
DEVELOPING BETTER REGIMENS THAT
ARE SAFER AND EASIER TO
TOLERATE, LONG-ACTING REGIMENS
THAT DON'T NECESSARILY HAVE A
SIGNIFICANT RISK OF RESISTANCE
THE WAY RILPIVIRINE DOES, SO
WE'RE HOPEFUL THAT MERCK HAS
SOME LONG-ACTING AGENTS COMING
FORWARD, WE HAVE LEN, MAYBE,
JUST MAYBE IF THE MOON GETS
RIGHT, GILEAD AND VEVE CAN GET
TOGETHER AND FIGURE OUT HOW TO
SPEAK TO EACH OTHER.
WE'LL SEE HOW THAT GOES.
BUT WE REALLY WILL NEED TO
CONTINUE TO WORK ON DEVELOPING
LONG-ACTING AND SUSTAINED
RELEASE FOR GLOBAL USE.
WHAT WOULD REALLY HELP IS IF WE
HAD ACCESS TO ASSAYS.
THINK ABOUT THE NUMBER OF COVID
TESTS, WE'VE ALL TAKEN
COLLECTIVELY IN THIS ROOM OVER
THE PAST THREE OR FOUR YEARS, IF
WE HAD A POINT OF CARE
DIAGNOSTIC OR A HAND-BASED
DIAGNOSTIC THAT COULD GIVE YOU
VIRAL LOAD, I MEAN, THAT WOULD
BE SUCH A HUGE STEP FORWARD FOR
CURE AS WELL AS FOR HIV THEIR
TICS.
WE HAVE TOOLS COMING FORWARD TO
MONITOR ADHERENCE THROUGH HAIR
AND URINE.
WE REALLY NEED TO CONTINUE TO
IMPROVE THERAPEUTIC OPTIONS FOR
PREGNANT PEOPLE AND FOR CHILDREN
SO THEY GET TO A PLACE THAT
THEY'RE ON PAR WITH NON-PREGNANT
ADULTS, AND REALLY SEEK TO
OPTIMIZE LONG-ACTING FOR
PEDIATRICS.
THAT WOULD BE SUCH A GAME
CHANGER, PARTICULARLY WHEN YOU
GET INTO ADOLESCENCE.
WHERE YOU HAVE KIDS THAT JUST
DON'T WANT TO TAKE THEIR MEDS
ANYMORE.
WE NEED TO REALLY THINK
CAREFULLY ABOUT HOW WE USE
BNABs.
THIS GENERATION OF BNABs THAT
WE CURRENTLY HAVE, BUT BNABs
LIKE THE ONES TED SHOWED TODAY,
THERE ARE MORE OF THESE IN THE
PIPELINE THAT WILL REALLY
NEUTRALIZE 95, 97, 99% OF ALL
VIRUSES CIRCULATING.
CD4IG REMAINS THE GOLD STANDARD.
WE NEED TO BE ABLE TO FIGURE OUT
HOW TO USE CD4IG AND THAT WILL
PROBABLY REQUIRE GENE THERAPY TO
GET US TO THAT POINT.
THROUGH BEHAVIORAL AND SOCIAL
SCIENCE, UNDERSTAND ADHERENCE
CHALLENGES AND HOW BEST TO
MANAGE THOSE, AND IMPROVE
IMPLEMENTATION AT SCALE THROUGH
PARTNERSHIPS.
UNDER CURE, REALLY, THIS IS
ABOUT UNDERSTANDING -- I THINK
THERE'S A STRONG BASIC SCIENCE
COMPONENT HERE.
WE REALLY NEED TO UNDERSTAND
WHAT THE BIOLOGY IS ASSOCIATED
WITH MAINTAINING THE RESERVOIR
IN THE STRUCTURE OF WHERE THAT
LATENT CD4 CELL, WHAT ARE THE
SURROUNDING STROMA THAT KEEP
THAT CELL NOURISHED AND KEEP IT
ALIVE AND KEEP IT EITHER
PROTECTED FROM T CELLS OR KEEP
IT IN A STATE THAT MAKES IT EASY
FOR TO ACTIVATE AND RESPOND.
SO THE RESERVOIR ISN'T JUST ONE
CELL, IT ISN'T AN ENVIRONMENT,
THE WAY CANCER IS NOT A SINGLE
CELL BUT IT IS IN THE TISSUE AND
THE WAY THE CANCER EXPLOITS THE
TISSUE TO ITS OWN BENEFIT.
WE REALLY NEED TO UNDERSTAND,
THAT'S NOT A GOAL OF THE
NETWORK.
THE GOAL OF THE NETWORK IS TO
REALLY COME UP WITH STRATEGIES
THAT WILL UNDERSTAND THE BIOLOGY
AND DEVELOP WAYS OF ERADICATING
THE REPLICATION CONFIDENT
RESERVOIR AND/OR CONTROL REBOUND
IN THE ABSENCE OF ANTIRETROVIRAL
THERAPY.
AND HERE THE PEDS GROUP WITH
P1115 HAS REALLY BEEN AT THE
CUTTING EDGE WITH GETTING A
COHORT TO APPOINT WHERE THEY
COULD UNDERGO A SUBSTANTIAL
EXPLORATION OF STRUCTURED
TREATMENT INTERRUPTIONS IN
CHILDREN.
MAYBE WE LOST EVERYBODY ONLINE,
BUT -- DID WE LOSE THE ZOOM
LINK?
NO?
I'LL KEEP GOING THEN.
BUT REALLY, THIS IS A CHALLENGE
FOR US AS WE GO FORWARD.
AND IMPACT ON ACTG WILL BE THE
LEAD, BUT REALLY THIS IS GOING
TO REQUIRE THE COLLABORATORIES
AND OTHER GROUPS TO BE
CONTINUING TO DEVELOP REALLY
NOVEL STRATEGIES THAT CAN MOVE
FORWARD INTO ADVANCED CLINICAL
STUDIES.
SOSO I TALKED ABOUT THE NEED TO
REALLY IDENTIFY AND CHARACTERIZE
RESERVOIRS, WE NEED TO DEVELOP
STRATEGIES.
WE NEED TO THINK ABOUT MODIFYING
BNABs SO THEY HAVE THE
APPROPRIATE FC FUNCTIONS AS WELL
AS OTHER LEVELS OF ABILITY TO
NEUTRALIZE VIRUS BECAUSE RIGHT
NOW, EVEN THE BEST COCKTAIL DOES
NOT NEUTRALIZE ALL THREE --
ANTIBODIES DO NOT NEUTRALIZE ALL
THE VIRUSES, SO WHY WOULD YOU
START WITH A -- FROM A
PERSPECTIVE OF THAT YOU'RE UNDER
100%, WE HAVE DRUGS THAT ARE
UNDER 100% EFFECTIVE AT BLOCKING
VIRUS.
WHY WOULD WE START GIVING
ANTIBODIES TO PEOPLE IF WE
ALREADY KNOW THAT THERE'S GOING
TO BE RESISTANCE THAT WILL
EMERGE OR THAT THERE WILL BE A
UNBOUND FRACTION THAT WILL NOT
BE NEUTRALIZED BY THOSE
ANTIBODIES.
AND WE NEED TO ALSO DO SOME WORK
IN TAILORING CURATIVE STRATEGIES
AT THE INDIVIDUAL LEVEL, JUST TO
SEE WHAT WILL WORK AND WHAT
WON'T.
WE NEED TO DEVELOP A PIPELINE,
CONTINUE TO DEVELOP A PIPELINE,
IN ADVANCE.
THESE COMBINATIONS OF STRATEGIES
AS THEY COME ALONG INTO ADULTS
AND CHILDREN AS RAPIDLY AS
FEASIBLE.
AND ALSO FOCUS ON THE EQUITY
QUESTION HERE.
HOW CAN WE MAKE SURE THAT THE
POPULATIONS MOST IN NEED HAVE
EQUAL ACCESS, NOT JUST BASED ON
GEOGRAPHY BUT ALSO BASED ON
LIFESPAN.
AND WE NEED TO ALSO THEN AS I
WAS SAYING BEFORE, LINK CURE TO
PREVENTION OF VERTICAL
TRANSMISSION ACTIVITIES.
I THINK THIS IS GOING TO BE A
REALLY IMPORTANT ACTIVITY FOR US
GOING FORWARD TO USE THE TOOLS
AND TECHNOLOGIES OF HIV
PREVENTION TO CREATE A WAY OF
SIGNIFICANTLY REDUCING THE
NUMBER OF BABIES BORN WITH HIV,
BUT THEN MAKE SURE THAT WE DO
OUR BEST TO TAKE THOSE CHILDREN,
GET THEM ON ANTIRETRO VIRAL
THERAPY, THROUGH THE CARES
SYSTEMS, MAINTAIN THEM IN CARE
BUT ALSO, IF APPROPRIATE, OFFER
THOSE PARENTS THE OPPORTUNITY
FOR RESEARCH TO HELP THEIR
CHILDREN.
SO WITH THAT, I'LL PAUSE.
THAT WAS REALLY GRANULAR, AND I
REALIZE I TALKED A HECK OF A LOT
LONGER TO YOU THAN I NORMALLY
DO, BUT I THOUGHT IT WAS
IMPORTANT FOR YOU TO SEE SOME OF
THE BACKGROUND THAT WE'RE
THINKING ABOUT IN TERMS OF
STRATEGIES AND APPROACHES AS WE
GO FORWARD.
SO QUESTIONS, PLEASE.
>> SHOULD WE START ONLINE AND
SEE IF THERE'S ANYONE ON ZOOM
WITH A QUESTION?
OKAY.
LET'S JUST COME AROUND.
I THINK THERE WILL BE LOTS OF
QUESTIONS.
FLEURN
>> SO THANKS, CARL.
I APPRECIATED THE GRANULARITY,
AND I FEEL LIKE YOU HAVE THE
HARDEST TIME SLOTS TODAY, RIGHT
AFTER LUNCH AND AT THE END OF
THE DAY.
WHAT I WANTED TO ASK ABOUT WAS
TWO THINGS.
IT SOUNDS LIKE FROM THE 2017
PLAN, ONE LESSON THAT YOU HAVE
LEARNED IS THINKING ABOUT MAYBE
SOME OF THOSE TARGETS WERE
AMBITIOUS BECAUSE WE DIDN'T
FULLY UNDERSTAND THE
FOUNDATIONAL ELEMENTS WE NEEDED
TO UNDERSTAND SO IT'S GOING BACK
TO BASICS IN SOME WAYS.
SO I JUST WANTED TO CONFIRM IF
THAT'S RIGHT, IF I'M GETTING IT.
AND THE SECOND THING WAS WITH
HIV CURE RESEARCH, YOU TALKED
ABOUT GOING IN TO CHILDREN AS
RAPIDLY AS FEASIBLE.
OBVIOUSLY WITH VERY EARLY
ANTIRETROVIRAL THERAPY THAT MADE
SENSE AND THAT WAS IMPORTANT, I
THINK THERE'S THIS QUESTION
ABOUT WHEN IT IS ETHICALLY
ACCEPTABLE TO TEST SOME OF THESE
CURE STRATEGIES IN CHILDREN,
GIVEN SOME OF THEM ARE QUITE
TOXIC AND HAVE ART, SO I'M
CURIOUS WHAT YOU THINK ABOUT
THAT.
IS IT THE RIGHT TIME OR IS THERE
STILL SOME NEED FOR TESTING OR
ARE THERE CERTAIN APPROACHES
THAT YOU THINK MIGHT BE KIND OF
READY TO BRING IN TO YOUNGER
POPULATIONS NOW?
>> SO THINK THE PEW TEE OF BEAUF
WORKING WITH IMPACT IS THEY
REALLY GOOD AT CONSULTATION, AND
THINK THE VISION OF FEASIBILITY
HAS TO TAKE INTO ACCOUNT THE
SAFETY COMPONENT OF THAT.
BUT THE IDEA IS, LET'S THINK IN
A WAY THAT WE'RE -- WE HAVE A
GOAL, AND I WOULD LIKE TO THINK
ABOUT WE'RE NOT PROTECTING
PEOPLE FROM RESEARCHMENT I
REALLY WOULD LIKE TO GET AWAY
FROM THAT PARADIGM, BUT WE'RE
ENGAGING PEOPLE IN THE
OPPORTUNITY OF RESEARCH, WE'RE
PROVIDING THE APPROPRIATE
EDUCATION TO THE PROVIDER, TO
THE PERSON GIVING THE INFORMED
CONSENT.
SO THE PARENT OR PERSON OFFERING
THE REBEINGOFFERED THE RESEARCHE
THEIR DECISION.
THAT'S WHAT I MEAN BY FEASIBLE.
I THINK THE MORE WE CAN GET TO
THE SENSE OF WE'RE NOT
PROTECTING YOU FROM RESEARCH,
WHETHER IT'S THE SPECIAL
POPULATION -- I MEAN, JEANIE
TALKED ABOUT IT TODAY, IN
PREGNANCY, CAN WE EXPAND THE
TYPES OF STUDIES WE'RE DOING IN
PREGNANCY?
YES, THERE WILL BE DRUGS THAT
HAVE NO BUSINESS GOING IN TO
PREGNANT PEOPLE OR INTO
CHILDREN, BECAUSE THEY DON'T
HAVE A SAFETY PROFILE.
BUT ONCE THERE'S A SAFETY
PROFILE ASSOCIATED WITH THAT
DRUG, WE NEED TO HAVE THE
CONVERSATION.
ULTIMATELY THE FDA IS GU GOING O
HAVE A SAY IN THIS TOO.
>> I THINK I AGREE WITH YOU
COMPLETELY ABOUT THE IDEA OF
PROTECTING PEOPLE THROUGH
RESEARCH AS APPROPRIATE, AND AS
ANNIE AND COLLEAGUES HAVE
ARGUED, AND I THINK A LOT OF THE
TERMINOLOGY THEY USE IS SORT OF
RESPONSIBLE INCLUSION, RIGHT,
THAT YOU THINK ABOUT HOW DO YOU
BRING PEOPLE IN WHEN IT'S RIGHT,
AND WITH PREGNANT PEOPLE IN
PARTICULAR, THEY ARE MAKING
THEIR OWN DECISIONS IN MANY
WAYS, SO THEY ARE -- THE IDEA OF
THEM AS VULNERABLE DOESN'T
REALLY MAKE SENSE.
SO I'M COMPLETELY ON BOARD
THERE.
I THINK WHEN IT COMES TO
PEDIATRIC RESEARCH, PART OF THE
CHALLENGE IS WE HAVE THIS RE
REGULATORY SYSTEM AND WE HAVE
PROXY CONSENT WHERE SOMEBODY
ELSE IS MAKING DECISIONS FOR
CHILDREN.
SO I THINK YOU'RE ABSOLUTELY
RIGHT TO BE LOOKING FORWARD TO
WHEN THE TIME IS RIGHT TO OFFER
THOSE OPPORTUNITIES TO CHILDREN
BUT WE STILL HAVE TO DO IT
WITHIN THE RISK/BENEFIT RATIOS
THAT HAVE BEEN DETERMINED TO BE
APPROPRIATE FOR KIDS WHEN
THEY'RE NOT THE ONES MAKING --
>> THAT'S ONE OF THE THINGS I
REALLY LOVED ABOUT P1115, IS THE
GOAL WAS GET THE NEWBORN ON THE
BEST DRUGS, THE BEST
ANTIRETROVIRALS AS SOON AS
POSSIBLE.
THAT'S CARE.
AND THAT'S APPROPRIATE.
BUT THEN AS THAT CHILD GROW,
YOU'VE DONE SOMETHING TO CHECK
THE EXPANSION OF THE RESERVOIR
HOPEFULLY, AS LONG AS THEY STAY
VIRALLY SUPPRESSED, AND THE WAY
DR. PRASAD SET THAT WHOLE STUDY
UP WAS A SERIES OF GATES.
BUT WITH BETTER DRUGS, MORE KIDS
WILL FLOW THROUGH THOSE GATES
AND GET TO A POINT WHERE THE
PARENTS CAN GET COMFORTABLE WITH
THIS KIND OF AN APPROACH.
SO THAT'S THE KIND OF -- AND
THAT'S WHY I THINK THIS LINKAGE
TO DELIVERY OF -- THROUGH
IMPLEMENTATION SCIENCE, BETTER
PREVENTION AND TREATMENT
STRATEGIES TO PREGNANT PEOPLE,
WHETHER THEY'RE LIVING WITH HIV
OR VULNERABLE TO HIV WILL BE
REALLY AN IMPORTANT WAY OF
KEEPING THE EDUCATION GOING FOR
THESE FAMILIES AS THEY GO
FORWARD.
>> RAVI?
>> THANK YOU I WOULD AGREE THE
GRANULARITY WAS HELPFUL.
IT WAS GREAT THAT YOU FOCUSED ON
THIS OPPORTUNITY FOR PREGNANT
PEOPLE AND PREVENTION STRATEGIES
TO THEN FEED A CURE AGENDA,
WITHIN THAT POPULATION, BUT THEN
I THINK THERE'S ALSO AN
OPPORTUNITY TO CONTINUE
SYNERGIES AMONG ADULTS OR NOT
PERINATAL -- PERINATALLY
ACQUIRED SITUATIONS WHERE THE
PREVENTION NETWORKS AND THEIR
FAILURES FOR LACK OF A BETTER
WORD HAVING SMALL RESERVOIRS
POTENTIALLY AS YOU KNOW, CURRENT
ACTGHPGN COLLABORATION AND THAT
CAN BE BROKERED IN A WAY THAT
WILL FEED THE CURE AGENDA MORE
COLLABORATIVELY?
>> I REALLY LIKE THAT IDEA,
BEING ABLE TO CAPTURE PEOPLE --
CAPTURE IS THE WRONG WORD --
IDENTIFY PEOPLE THAT ARE NEWLY
CONVERTED IS AN IDEAL GOAL.
GOOD LOOK WITH THAT WITH YOUR
CAB.
>> MORE ABOUT THAT LATER.
>> BUT I ALSO DON'T WANT TO POKE
A BEAR THAT'S BEEN ADDRESSED
NUMEROUS TIMES IN THIS AND
PROBABLY OTHER SETTINGS BUT WHAT
IS THE CURRENT THINKING OF THE
DIVISION IN TERMS OF PREVENTION
PRODUCTS THAT DON'T OFFER
SYSTEMIC AND ONLY COMPARTMENTAL
OBLIGATION MOVING FORWARD,
PARTICULARLY AS WE SORT OF
INCORPORATE A PERHAPS EXPANDED
LENS ABOUT CHOICE?
>> WELL, WE ARE MOVING FORWARD
WITH A RECTAL DOUCHE, I THINK
THAT WILL BE AN IMPORTANT STUDY
TO SEE HOW TRULY EMBRACED SAID
PRODUCT IS, ARE THERE BE A
COMPANY WOULD'S WILLING TO BACK
TO TAKE IT FORWARD.
I THINK THE ISSUE REALLY COMES
DOWN TO HOW YOU GET A PRODUCT
LIKE THE LOGISTICS ON GETTING A
PRODUCT LIKE THAT APPROVED OR
FORMIDABLE.
IF YOUR COMPARATOR GROUP IS
EITHER INJECTABLE CABOTEGRAVIR,
OR LEN.
SO, I MEAN, WHAT YOU WENT
THROUGH IS AN ACTIVE CONTROL,
BUT YOU ALL DID IT RIGHT.
YOU ACTUALLY PROVIDED
APPROPRIATE COUNSELING TO THE
PEOPLE WHO WERE IN BOTH ARMS SO
THAT THEY KNEW THEY SHOULD BE
TAKING THEIR MEDICATIONS.
AND THE STUDIES DEMONSTRATED
RELATIVELY GOOD EFFECTIVENESS OF
ORAL TDFFTC BUT THE INJECTABLE
WAS STILL BETTER FOR BOTH
STUDIES.
I REALLY -- I DESPAIR ABOUT
BRINGING FORWARD SOMETHING THAT
ISN'T -- DOESN'T PROTECT AT THE
SAME LEVEL.
I MEAN, WE HAVE CONDOMS.
AND CONDOMS WOULD BE GREAT FOR
PREVENTING ALL STIs, BUT THEY
HAVE AN EFFECTIVENESS RANGE OF
ZERO TO 100, RIGHT?
SO IF YOU THEN THROW INTO THAT A
TOPICAL, IT'S LIKE I DON'T SEE
THE POINT, FRANKLY.
ONE OTHER THING IS, WHAT SHOULD
THE FEDERAL GOVERNMENT SPEND ITS
MONEY ON?
AND I THINK CHOICE THAT IS
EFFECTIVE WOULD BE THE IDEAL
THING TO SPEND OUR MONEY ON.
I'LL JUST LEAVE IT AT THAT.
SO THERE'S -- I'M SURE WE'LL
HAVE MORE DISCUSSIONS ABOUT
THIS.
>> THANKS.
WE'RE GOING TO KEEP GOING AROUND
THE ROOM.
OKAY.
>> CARL, YOU HAD A SLIDE THAT
TALKED ABOUT PARTNERSHIPS AND
PREVENTION, HAD A LOT OF PRIVATE
NGOs, SO FORTH, YOU HAD U.S.
GOVERNMENT ORGANIZATIONS,
PEPFAR, USAID, CDC.
I THOUGHT A GLARING ABSENCE
THERE WAS FDA, SO I'M WONDERING
WHETHER FIRST OF ALL THAT'S
INTENTIONAL, WHETHER THE FDA
NEEDS TO BE KEPT AT ARM'S LENGTH
BECAUSE OF THEIR UNIQUE ROLE,
WHETHER THEY'RE NOT -- I MEAN,
FDA IS BY NO MEANS MONOLITHIC.
THERE'S A TREMENDOUS DIFFERENCE
IN PHILOSOPHY BETWEEN A QUITE
FORWARD LOOKING DIAGNOSTIC
BRANCH BOTH OF WHICH ARE
INCREDIBLY IMPORTANT HERE, SO
JUST THOUGHTS ABOUT THAT IN
GENERAL.
>> SO I WILL ADMIT THAT THAT WAS
A GLARING OMISSION, BECAUSE THE
ROLE I SEE FOR FDA IS ONE OF AN
ADVISORY OR REGULATORY BODY THAT
BASICALLY LOOKS AT THE WORK
THAT'S GOING ON AND PASSES
JUDGMENT ON IT.
I DON'T SEE THAT AS A
COLLABORATIVE EVENT.
ALTHOUGH I THINK THERE ARE
OPPORTUNITIES WHERE WE COULD
ENGAGE THEM IN WAYS THAT MAYBE
I'M NOT THINKING AS WELL AS I
SHOULD ABOUT THIS.
>> I'D JUST ENCOURAGE YOU TO
THINK ABOUT THAT.
AGAIN, BEING FAIRLY CLOSE TO THE
DIAGNOSTIC SIDE WHERE I'D SAY
YOU KIND OF FEEL LIKE YOU'RE
SHOUTING INTO THE WIND VERSUS
THE -- THANK YOU -- VERSUS THE
THERAPEUTIC BRANCH THAT ACTUALLY
COMES TO CONFERENCES AND SAYS IF
YOU WANT TO HAVE A GENE THERAPY
APPROVED, THIS IS WHAT WE THINK
YOU NEED TO SHOW, THAT'S
INCREDIBLY USEFUL TO THE FIELD.
>> AGREED.
>> AND ACTUALLY, GETTING A SENSE
THAT THEY'RE LISTENING IS VERY
ENCOURAGING TO THE FIELD AS
WELL.
SO I THINK IT'S WORTH THINKING
ABOUT HOW THE INDEPENDENCE OF
THAT ULTIMATE JUDGMENT CAN BE
MAINTAINED, BUT STILL THE ENTIRE
ENTERPRISE BE FACILITATED.
BECAUSE I THINK THAT'S
EVERYBODY --
>> I TAKE YOUR POINT AND I WILL
ADD THE FDA TO MY SLIDES.
THANK YOU.
THAT'S A REALLY IMPORTANT POINT.
>> CARL, I WAS JUST GOING TO ADD
THAT WE DO HAVE PARTNERSHIPS
WITH THE FDA IN CERTAIN
CIRCUMSTANCES WHERE THEY NEED
OUR HELP AND VICE VERSA SO THEY
CAME ACTUALLY TO THE ACTG FOR
HELP WITH -- IN THE STOMP TRIAL
AND THEN WE ALSO CONSULTED WITH
THEM VERY REGULARLY ON ACTIVE
2 DURING THE COVID PANDEMIC TO
GET THEIR EVOLVING ADVICE ON
CLINICAL END POINTS IN THAT
TRIAL, AND I THINK IN THE PAST
THEY'VE HAD REALLY VALUABLE
INPUT ON DESIGN ADVICE, WHEN
WE'RE TALKING ABOUT
COUNTERFACTUALS AND ALTERNATIVES
TO PLACEBOS.
SO IT'S A DIFFERENT TYPE OF
PARTNERSHIP, PARTNERS WHO ARE
BRINGING INTERVENTIONS,
DEVELOPING IN THE CASE OF
COMPANIES, BUT THEY ARE VALUABLE
PARTNERS.
>> ANY ADDITIONAL QUESTIONS?
CARL?
>> SO IF YOU HAVE THOUGHTS THAT
OCCUR TO YOU AND YOU WANT TO
WRITE, YOU CAN WRITE DIRECTLY TO
ME, OR YOU CAN PUT THEM IN ON
THE WEBSITE.
I'D LOVE YOUR FEEDBACK, AND THIS
REMAINS A WORK IN PROGRESS.
AND YOU'LL SEE A VERSION OF THIS
PROBABLY IN MORE TRUNCATED FORM
IN JANUARY AS WE GET READY TO
ASK YOUR APPROVAL FOR THE SIZE
AND SCOPE OF WHAT WE'RE MOVING
FORWARD WITH THE NETWORK.
SO THANK YOU.
>> THANK YOU.
AND I'LL REMIND EVERYONE THE
NEXT MEETING IS JANUARY 27TH.
IT WILL BE VIRTUAL AS CARL
MENTIONED, AND I THINK WE CAN
ADJOURN THE MEETING.
THANKS, EVERYONE.