IT IS MY PLEASURE ALSO
SPECIFICALLY TODAY TO WELCOME
MR. LOUIS SHACKLEFORD, WHO HAS
KINDLY AGREED TO STEP IN AND
FILL THE SHOES OF S TEPHAUN, I'M
NOT SURE, MAYBE THE TWO OF US
COULD FILL HIS SHOES.
IN THE MEANTIME, LOUIS IS ACTING
EXTERNAL RELATIONS DIRECTOR FOR
HVTN AND PUBLIC HEALTH
COMMUNICATIONS, WORK INCLUDES
GUIDING STAKEHOLDER ENGAGEMENT
STRATEGIES, SPEARHEADING
COMMUNITY PARTNERSHIPS, EXTERNAL
STUDY COMMUNICATIONS, DEVELOPING
RESEARCH AWARENESS AND
EDUCATIONAL INITIATIVES FOR
DOMESTIC AND GLOBAL HIV COVID
VACCINE TRIALS.
JOHN ME IN WELCOMING HIM TO
ARAC.
IT IS MY PLEASURE TO LET YOU
KNOW THAT JEANNE MARRAZZO HAS
BEEN SELECTED AS NIAID DIRECTOR,
NO STRANGER TO HIV RESEARCH.
SHE HAS BEEN A FIXTURE IN OUR
COMMUNITIES FOR A VERY LONG
TIME.
IT IS GOING TO BE A REAL
PLEASURE TO HAVE HER AS THE
NIAID DIRECTOR.
SHE STARTS IN TWO WEEKS, WHICH
IS SO MUCH FASTER THAN WE
THOUGHT COULD HAPPEN AND WE'RE
REALLY EXCITED.
TO I WISH I HAD THE SLIDE TO
SHOW YOU, BECAUSE THE ENTIRE
DIRECTOR SUITE IN BUILDING 31
HAS BEEN STRIPPED OF EVERYTHING
TO CONCRETE AND POSTS BECAUSE OF
AN ASBESTOS ISSUE AND NOW THEY
HAVE TO BUILD IT BACK UP.
SO HOPEFULLY SHE WILL HAVE A
SENSE OF WHAT SHE CAN DO AND
HELP DESIGN HER NEW OFFICE.
IN TERMS OF RETIREMENTS, TWO
PEOPLE THAT HAVE RECENTLY
RETIRED.
YOU KNOW I'M NOT ALLOWED TO SAY
THAT ABOUT DR. FAUCI.
HE'S MOVED ON.
MARY HAS RETIRED.
MARY RETIRED IN EARLY AUGUST,
AFTER 12 YEARS OF LEADING THE
HIV VACCINE RESEARCH PROGRAM IN
THE DIVISION OF AIDS.
SHE WAS RESPONSIBLE FOR
OVERSEEING SO MANY OF THE LARGE
HIV VACCINE TRIALS INCLUDING THE
AMP STUDIES, SHE REALLY HELPED
DRIVE THE COVID VACCINE PROGRAM
AND WAS ESSENTIAL IN HELPING TO
GET ALL THE THOSE ACTIVITIES
STOOD UP.
WHEN JOHN MASCOLA SET UP HIS
PROGRAM, HE HAND PICKED HIS TEAM
OF PEOPLE TO HELP DRIVE THE
VACCINE WORK.
HE PICKED MARY AND HE PICKED
COLLEAGUES FROM MHRP, AND THEY
TOGETHER WORKING WITH DIVISION
STAFF AND ACROSS THE GOVERNMENT
REALLY HELPED PUSH THE TRIALS
FORWARD.
SHE ALSO LED ON THE MONOCLONAL
ANTIBODY WORK.
SHE HAS MOVED ON AND RETIRED,
AND JIM LANE HAS BEEN THE LUCKY
RECIPIENT, PULLED THE GOLDEN
TICKET AND GETS TO BE ACTING
DIRECTOR OF THE VACCINE RESEARCH
PROGRAM.
JIM IS AN EXPERIENCED CLINICAL
IMMUNOLOGIST IN THE LAB, SO IT'S
A PLEASURE TO WELCOME JIM TO THE
TABLE AND WORKING WITH HIM QUITE
CLOSELY.
THE SEARCH FOR THE VACCINE
RESEARCH PROGRAM DIRECTOR OPENS
THE SAME DAY AS JEANNE SHOWS UP
HERE IN BETHESDA, SO IF YOU HAVE
CANDIDATES THAT ARE INTERESTED,
JIM WOULD LIKE TO KNOW AND
STRONGLY ENCOURAGE YOU TO SEND
NAMES, ADDRESSES, RÉSUMÉS.
WE WILL BE MOUNTING A GLOBAL
SEARCH AND WE'RE LOOKING FOR A
STRONG CANDIDATE TO TRY TO FILL
MARY'S SHOES.
I'D LIKE TO WELCOME CATHERINE
YEN, WHO REALLY HAS BEEN IN THE
DIVISION FOR A VERY LONG TIME,
BUT SHE'S NOW TAKEN THE ROLE OF
CHIEF OF PROTECTION OF
PARTICIPANTS, EVALUATION, AND
POLICY BRANCH IN THE OFFICE FOR
POLICY IN CLINICAL RESEARCH
OPTIONS; OPCRO.
THIS IS A PROMOTION FOR HER AND
SHE'S LOOKING FORWARD TO
FULFILLING THE ROLES.
GREAT TO HAVE CATHERINE IN THIS
ROLE.
NOW THE FUN PART OF THE
PRESENTATION TODAY, THE BUDGET
UPDATE.
SO THIS IS THE STATE OF PLAY WE
WERE A YEAR AGO.
WE HAD FISCAL YEAR 23 BUDGET
PASSED, IT HAD A NICE INCREASE
FOR US OF 3.8%, BUT COMPARED TO
OTHER INSTITUTES WE WERE A
LITTLE LOWER BUT PLEASED WITH
3.8%.
FAST FORWARD TO NOW, HUGH MADE
THE POINT WHEN HE SHOWED THIS
SLIDE TWO BIGGEST GROWTH AREAS
ARE AT YOUR RIGHT, THE BLUE
CIRCLE THAT'S OD, APPARENTLY
USED TO BE THE SIZE OF NIDCR OR
BUILDING AND FACILITIES.
AND NIA HAS ALSO UNDERGONE
EXPLOSIVE GROWTH.
WHAT WE SEE WHEN WE LOOK AT
FISCAL YEAR 24 IS EVEN UNDER THE
BEST SCENARIO WE'RE AT LEVEL
FUNDING IN THE PRESIDENT'S
BUDGET.
THIS SLIDE SHOWS FOR NIAID WHAT
THE HOUSE AND SENATE MARKS ARE.
YOU SEE THE HOUSE MARK
REPRESENTS A 22.9% CUT FOR
NIAID.
AND THE SENATE MARK IS LEVEL
FUNDING.
THE HOUSE HAS BEEN OUT OF
SESSION.
THEY COME BACK TOMORROW.
AND THEN THE DISCUSSIONS WILL
BEGIN IN EARNEST ABOUT A
CONTINUING RESOLUTION OR PASSING
A BUDGET FOR THE -- ULTIMATELY
WE'LL GET TO PASSING A BUDGET
FOR FISCAL YEAR 24.
THE BEST BETS ARE THAT THE
SENATE WILL HELP TO GUIDE TO A
LEVEL CLEAN CONTINUING
RESOLUTION, HOPEFULLY IT WILL
PASS BY THE 34th OR 35th OF
SEPTEMBER.
BECAUSE THAT'S THE WAY THINGS
WORK IN WASHINGTON.
YOU JUST EXTEND OVER THE WEEKEND
AND THEN MONDAY HOPEFULLY THEY
WILL HAVE SOMETHING SIGNED.
NOW WE'LL SEE WHAT HAPPENS WITH
THAT.
BUT IT'S GOING TO BE A BUMPY
RIDE FOR A WHILE.
SO, WE'RE STARTING THE YEAR VERY
CONSERVATIVELY.
WE'RE GOING TO START WITH AN
ESTABLISHED PAYLINE OF THE 8th
PERCENTILE WITH NEW P.I.s WHO
QUALIFY AT THE 12th
PERCENTILE.
THE INSTITUTE HAS MADE THE
STRATEGIC DECISION NOT TO CUT
NON-COMPETING AND COMPETING
GRANTS, OTHER INSTITUTES HAVE
DONE THAT ROUTINELY.
WE'RE OPTING TO MAINTAIN POINT
OF VIEW NO ADJUSTMENTS SHOULD BE
MADE.
WE'RE STARTING WITH A BUDGET
EXERCISE THAT REDUCES RESEARCH
INITIATIVES BY 30% AND ALL OF
THIS TOTALED UP LISA TO SUCCESS
RATE OF -- LEADS TO A SUCCESS
READ BETWEEN 13 AND 16%.
WE'LL SEE WHAT HAPPENS WHEN WE
GET A FORMAL BUDGET FOR THE
YEAR.
WE'LL MAKE ADJUSTMENTS BASED ON
DOLLARS AVAILABLE TO THE
PAYLINE, AS -- ONCE A FORMAL
BUDGET IS ADOPTED FOR FISCAL
YEAR 24.
WE'LL PROBABLY BE TALKING ABOUT
THIS AGAIN IN JANUARY, MAYBE BY
THEN WE'LL HAVE THE FINAL
BUDGET.
JUST A COUPLE SMALL SCIENTIFIC
UPDATES.
I SHOULD HAVE TURNED IT OFF.
APOLOGIZE.
A COUPLE SCIENTIFIC UPDATES.
FIRST IS THE FINAL ACTION FROM
THE U.S. PREVENTIVE SERVICES
TASK FORCE HAS BEEN PUBLISHED,
MAKING LONG-ACTING PrEP AND
ORAL PrEP BOTH TDF AVAILABLE
OR RECOMMENDED AS GRADE A UNDER
THE WAY THE LEGISLATION HAS BEEN
WRITTEN, BOTH THESE SHOULD ALL
BE AVAILABLE THROUGH INSURANCE
FREE OF CHARGE.
HOWEVER MANY ARE AWARE THERE'S
MOVEMENT FROM THE FIFTH CIRCUIT
TO STRIP THESE KINDS OF THINGS
OUT OF THE LEGISLATION SO WE'LL
SEE WHAT HAPPENS.
FOR NOW, IF THERE IS NO CHANGE,
WE SHOULD BE ABLE TO GET TO A
GOOD PLACE AND HAVE THESE
AVAILABLE.
IT'S REALLY INTERESTING TO THINK
ABOUT GOING BACK TO 2008, 2009,
WHEN WE STARTED THE IPREX TRIAL,
THINKING ABOUT WHAT A RISK
PEOPLE THOUGHT THAT WAS.
HERE WE ARE NOW 15, 18 YEARS
LATER, IT HAS GRADE A FROM
PREVENTIVE SERVICES TASK FORCE.
CONTRAST THAT TO WHAT IS SEEN
WITH INJECTABLE CAV WHERE THE
TIME HAS SHRUNK, A FANTASTIC
PLACE TO BE.
WE LOOK FORWARD TO OPPORTUNITIES
BECAUSE CHOICE IS WHAT THIS IS
ABOUT.
IT WOULD BE GOOD TO HAVE
ADDITIONAL CHOICES THAT HAVE A
GRADE A, THAT WOULD BE ALLOWED
FOR PEOPLE AT RISK OF ACQUIRING
HIV.
SEPTEMBER 1, THE FINDINGS FROM
THE AC TIV-2/AIDS TRIALS, EIGHT
MANUSCRIPTS INCLUDED, A TOUR DU
FORCE, CONGRATULATIONS TO THE
ACTIV-2 TEAM, IN THE DIVISION,
ACTG AND SITES.
I ENCOURAGE YOU TO LOOK AT THIS
BECAUSE WE'RE NOT DONE WITH
THERAPEUTICS IN COVID, BY ANY
MEANS.
NOW I GET TO MOVE THROUGH TWO
CONCEPTS FOR APPROVAL.
I'LL EXPLAIN WHY.
ONE OF THE AREAS THAT WE'RE
TRYING TO ADJUST IS HOW WE
ADVANCE THE RESEARCH THAT IS
DONE THROUGH CERTAIN PROGRAMS IN
THE DIVISION.
ONE OF THE PROGRAMS THAT IS
CONGRESSIONALLY MANDATED WAS THE
ENDING THE HIV EPIDEMIC, AND THE
FUNDING HAD BEEN GIVEN TO THE
DIVISION ON A YEARLY BASIS, AND
WE WERE GIVEN INSTRUCTIONS THAT
THOSE FUNDS WERE TO MOVE THROUGH
THE CENTERS PROGRAMS OF THE
DIVISION OF AIDS, THE NIH, THE
CFARs AND THROUGH THE AHRQ
PROGRAMS OF NIMH.
AND SINCE 2018 TILL NOW, WE HAVE
MOVED THAT MONEY AT $26 MILLION
A YEAR THROUGH THOSE VEHICLES,
AND IT HAS CREATED A LOT OF
WORK FOR THE GRANTEES IN TERMS
OF WRITING SUPPLEMENT REQUESTS,
OR DIVISION STAFF FOR REVIEW
PURPOSES, AS WELL AS THE GRANTS
MANAGEMENT PEOPLE TO PUT THESE
TOGETHER AND GET THEM FUNDED.
SO WHAT WE'RE DOING THROUGH THIS
NOSI IS TO CHANGE HOW WE'RE
SOLICITING THIS RESEARCH FOR THE
IMPLEMENTATION SCIENCE TO
ADDRESS THE GOALS OF HHS ENDING
THE EPIDEMIC.
WE'RE GOING TO MOVE TO A
SOLICITATION FOR R01s, R21s,
R34s THAT WILL ALLOW
INVESTIGATORS THAT ARE WORKING
WITHIN A SPECIFIC JURISDICTION,
ALL LAID OUT, ADDRESSING
PRINCIPLES OF EHE TO APPLY FOR
FUNDING TO TAKE WHAT WE'VE
LEARNED FROM ALL OF THESE
HUNDREDS OF SUPPLEMENTS THAT WE
HAVE FUNDED AND PUT THIS INTO
MAYBE SOME MULTI-YEAR PROJECTS
WHERE WE CAN REALLY LOOK AT
IMPLEMENTATION WITH OUR PARTNERS
AT CDC AND HRSA, TAKING THE WORK
WE'VE SUPPORTED TO THE NEXT STEP
BY TAKING THIS ACTION.
THIS IS A NECESSARY PROCESS TO
HELP TO PUT THIS MONEY IN A
DIFFERENT FORM, DIFFERENT
PLACES, WHERE IT CAN TRULY HAVE
GREATER IMPACT THAN THE YEARLY
SUPPLEMENTS, STOP-START,
STOP-START, TRYING TO BUILD A
SUPER HIGHWAY FOR RESEARCH AND
IMPLEMENTATION SCIENCE THAT
WE'RE SUPPORTING UNDER THIS
PROGRAM BY PUBLISHING THIS NOSI.
THE PARTNERSHIPS OF THE GROUPS
OF THE INSTITUTES THAT ARE
ALREADY PART OF THE CFAR PROGRAM
ARE AN ESSENTIAL PART.
YOU SEE THAT'S WHY ALL THOSE
INSTITUTES OAR ARE LISTED WE
LOW.
I'VE EXPLAINED THIS BACKGROUND
ALREADY.
SO THE BOTTOM LINE IS
COLLECTIVELY WE FUNDED OVER 400
COMMUNITY-BASED ORGANIZATIONS,
ACADEMIC INSTITUTIONS, HEALTH
DEPARTMENTS.
AND LOCAL BUSINESSES TO CONDUCT
THIS RESEARCH.
IT'S REALLY NOW TIME TO TAKE THE
BEST OF THIS WORK AND APPLY IT
IN A MORE JUDICIOUS WAY.
AGAIN, IN TERMS OF PRIORITY
TOPIC AREAS, WE WANT TO IMPROVE
ENGAGEMENT AND REENGAGEMENT FOR
TESTING, TREATMENT, CARE
SERVICES.
AND THIS STUDY CAN FOCUS ON
PEOPLE EXPERIENCING UNSTABLE
HOUSING OR HOMELESSNESS, WITHIN
COMMUNITIES AFFECTED BY CLUSTERS
AND OUTBREAKS AS WELL AS SCALE
UP STRATEGIES TO DELIVER
PREVENTION AND TREATMENT
SERVICES TO ADDRESS
COMORBIDITIES AND CO-INFECTIONS.
ALL OF THIS IS DONE IN
PARTNERSHIP WITH THE
COMMUNITY-BASED ORGANIZATION,
AND WITHIN THE CONCEPT OF
WORKING WITH HRSA OR CDC
PARTNERS WITHIN ONE OF THE
JURISDICTIONS AT THIS POINT.
SO THAT'S THE PURPOSE OF THIS
SPECIFIC NOSI.
I'LL TAKE QUESTIONS ON THIS, AND
THEN I KNOW I'M RUNNING LATE.
SO IF THERE ARE ANY QUESTIONS,
I'LL TAKE THEM.
IF YOU WOULD VOTE ON THIS
CONCEPT IN THE ECB, IN THE
MEANTIME.
AS WE WERE GOING THROUGH AND
PUTTING TOGETHER THE INITIATIVE
I JUST DISCUSSED, WE REALIZED
THAT WE DID NOT HAVE A SIMPLE
MECHANISM FOR TAKING IN THESE
SIMILAR KINDS OF SUPPLEMENT
REQUESTS FOR THE CFARs
PROGRAM.
SO THIS INITIATIVE IS TO CREATE
COMPETING REVISIONS TO THE
EXISTING CFAR GRANTS AS WELL AS
DEVELOPMENTAL CFARs TO ALLOW
THEM TO APPLY FOR, THROUGH THIS
METHOD, TO TAKE PROGRAMS THAT
THEY HAVE BEEN -- WE'VE BEEN
FUNDING, SUPPLEMENTS YEAR BY
YEAR BY YEAR, TO ESSENTIALLY
COMPETE FOR THOSE AND PUT THEM
IN THE PARENT GRANT, A
STREAMLINING EXERCISE TO TAKE
EXISTING PROGRAMS THAT WE'VE
BEEN COMPETING FOR THE CFARs
ON A YEARLY BASIS AND LITERALLY
BUNDLE THEM AND THEN PUT THEM
WITHIN THE PARENT AWARD.
THIS WILL STREAMLINE THE WORK
FOR THE CFARs, FOR PROGRAM
STAFF, AND FOR GRANTS
MANAGEMENT.
SO THAT'S WHY YOU SEE 20 AWARDS
HERE, BECAUSE THERE ARE 20
CFARs, AND THE HOPE IS THAT
ULTIMATELY EVERY CFAR WILL
CHOOSE TO APPLY.
IT'S IN THEIR BEST INTEREST
BECAUSE WE'RE NOT GOING TO HAVE
THESE SUPPLEMENTS ANYMORE, AS WE
GO FORWARD.
THE TIMES OF PROGRAMS WE'RE
GOING TO PUT INTO THIS ARE
PROGRAMS THAT ARE REALLY
IMPORTANT TO THE DIVISION AND
THE GRANTEES, ADELANTE LOOKS AT
PROGRAMS FOR HEALTH DISPARITIES
AMONG HISPANIC AND LATINX
POPULATIONS, ONE OF MY FAVORITE
PROGRAMS IS THE CDEIPI PROGRAM,
TAKING HIGH SCHOOL UNDERGRADUATE
AND GRADUATE STUDENTS,
POSTDOCTORAL FELLOWS, BRINGING
THEM TO OTHER INSTITUTIONS TO
EXPAND HORIZONS.
AFRICUE TO RECRUIT, MENTOR,
SUPPORT EARLY AND MID-CAREER
MENTORS FROM AFRICA TO BECOME
INDEPENDENT SCIENTISTS PURSUING
HIV CURE RESEARCH.
WE REALLY NEED THESE TO BE BUILT
IN A MULTI-YEAR WAY, IF I COULD
ASK YOU TO VOTE FOR THIS IN THE
ECB, I WOULD APPRECIATE THAT.
ANY QUESTIONS ON EITHER OF THESE
WHILE YOU'RE VOTING?
AUDREY?
>> I'LL SAY IT'S IMPORTANT, OUR
UNC CFAR, I HAD A STUDENT FROM
NC CENTRAL WORK WITH ME LAST
YEAR WHO WAS ACCEPTED TO ONE OF
THE NIH SUMMER TRAINING PROGRAMS
AFTER THAT, AND SHE'S PLANNING
TO GO TO GRAD SCHOOL.
YEAH, I THINK IT'S REALLY A
GREAT PROGRAM.
>> MONICA?
>> I AGREE, CDEIPI IS AMAZING.
NO MORE ADMINISTRATIVE
SUPPLEMENTS WOULD SAY MAYBE YOU
WANT MORE EQUIPMENT OR WE'RE
GOING TO FOCUS ON THIS?
>> WE WON'T HAVE THESE RECURRING
SUPPLEMENTS BUT THESE ARE
RECURRING.
EVERY YEAR WE ASK FOR AN
ADELANTE OR CDEIPI.
>> PERFECT.
>> THERE WILL BE OTHER PROGRAMS
THAT ARE ANNUAL, THOSE WERE JUST
LISTED AS EXAMPLES.
BUT YES, IF YOUR FREEZER BREAKS
WE'LL STILL BE ABLE TO HELP YOU.
AND TO REMIND YOU THE NEXT
COUNCIL MEETING WILL BE VIRTUAL
ON TUESDAY, THE 30th OF
JANUARY, NOT JANUARY 29th, AND
OTHER DATES FOR UPCOMING
MEETINGS ARE LISTED THERE.
THAT'S IT FOR ME.
ANY ADDITIONAL QUESTIONS FOR ME?
MELISSA?
>> PRE-EXPOSURE PROPHYLAXIS,
TRUVADA, LONG ACTING CAB, I'M
HERE TO REMEMBER COMMUNITY,
COMMUNITY PARTNERSHIPS, COMMUNIT
ADVOCACY, ENGAGEMENT, WORLDWIDE
THERE'S CONCERN ABOUT ACCESS TO
CAB-LA.
I RECOGNIZE WE'RE RESEARCH
INITIATIVE, WE DELIVER RESULTS,
BUT WHAT IS THE ROLE OR WHOSE
JOB IS IT TO ADDRESS SOME OF
THESE BARRIERS THAT WE'RE
EXPERIENCING WORLDWIDE FOR
PEOPLE TO HAVE ACCESS TO THE
CHOICE THAT YOU DESCRIBE?
IN TERMS OF THE PROBLEMS AND
CHALLENGES WITH PURCHASE
AGREEMENTS, DRUG PRICING, OTHER
NEGOTIATIONS, AGAIN I RECOGNIZE
THIS IS A RESEARCH ENDEAVOR THAT
WE'RE HERE FOR.
BUT, YOU KNOW, WE CONDUCT
RESEARCH TO CREATE THIS CHOICE,
CREATE OPPORTUNITIES FOR PEOPLE
TO HAVE THE BEST RESOURCES
AVAILABLE THAT THEY NEED TO
PROTECT THEMSELVES.
AND, AGAIN, I KNOW THIS IS
OUTSIDE OUR DIRECT PURVIEW, BUT
BECAUSE WE HAVE DELIVERED THIS
RESULT, IT TOOK SO MUCH EFFORT
THROUGH SYSTEMS AND NETWORKS AND
COMMUNITY AND SITES, ET CETERA,
EVEN PUSHING THROUGH A PANDEMIC
THAT COULD HAVE DERAILED THAT
STUDY, PEOPLE HAVE DEEPLY
INVESTED IN IT AND IT'S A
STRUGGLE THAT WE DON'T HAVE THE
ACCESS THAT WAS EXPECTED.
IF YOU COULD SHARE WHOSE JOB OR
WHOSE ROLE OR WHAT MORE CAN BE
DONE, IF ANYTHING, AND TO
COMMUNICATE THESE CONCERNS TO
THE LEADERSHIP AS IT'S
TRANSITIONING.
>> LEADERSHIP UP AND DOWN THE
CHAIN IS VERY AWARE OF CONCERNS
AND ISSUES THAT WE'RE FACING.
I THINK THE FIRST BIGGEST
CHALLENGE IS YOU'RE GETTING
ENOUGH OF THE PRODUCT
MANUFACTURED, SO THAT IT IS
AVAILABLE, IN-COUNTRY APPROVAL,
WORK WITH PARTNERS SUCH AS
PEPFAR, CLINTON HEALTH
INITIATIVE, AND OTHER GROUPS
THAT HAVE DONE SUPERB JOB ON
CONTROLLING PRICING FOR
ANTI-RETRO VIRALS.
NIH HAS NO VEHICLE OR HANDLE
OTHER THAN OUR ABILITY TO LOBBY
AND BE PART OF CONVERSATIONS TO
HELP AFFECT THOSE KINDS OF
THINGS BUT JUST CONTINUE TO
ADVOCATE.
>> THANK YOU.
THANK YOU FOR BRINGING UP THAT
CRITICAL ISSUE.
I WANT TO REMIND EVERYBODY
PLEASE INTRODUCE YOURSELF WHEN
YOU'RE SPEAKING, FOR THE FOLKS
ON ZOOM.
AND NOW ASK THE OFFICE OF AIDS
RESEARCH TO COME UP AND GIVE
THEIR REPORT.
I GATHER IT'S A TAG TEAM.
IS IT A TAG TEAM PRESENTATION?
>> YES.
>> IF YOU COULD EACH INTRODUCE
YOURSELF AS YOU SPEAK.
>> THANK YOU.
I'M DR. PAUL GAIST, NIH OFFICE
OF AIDS RESEARCH.
IS THIS BETTER?
BETTER, BETTER?
OKAY.
THANK YOU.
PAUL GAIST, NIH OFFICE OF AIDS
RESEARCH, SENIOR SCIENCE
ADVISER.
AND MY COLLEAGUES WILL INTRODUCE
THEMSELVES AS THEY COME TO THE
PODIUM.
OUR PRESENTATION TODAY ACTUALLY
IS A NICE SEGUE AND ROLL-THROUGH
FROM WHAT DR. DIEFFENBACH WAS
JUST SAYING ABOUT BRINGING
PEOPLE TOGETHER, CONCENTRATING
RESOURCES, THINKING HOW OUR
RESEARCH CAN APPLY TO EHE AND
OTHER TYPES OF PROGRAMS.
WE APPRECIATE THE OPPORTUNITY TO
PRESENT TO YOU TODAY.
BEGINNING WITH DISCUSSIONS
BETWEEN THE FORMER NIH OFFICE OF
AIDS RESEARCH DIRECTOR MAUREEN
GOODENOW AND DIRECTOR OF NIMH'S
DIVISION OF AIDS RESEARCH DIANNE
RAUSCH, A CORE PLANNING GROUP
WAS CHARGED WITH INCREASING AND
EVOLVING NIH'S ACTIVITIES, IN
THE HIV AND PHARMACY SPACE.
THIS AREA OF INTEREST WAS THEN
SUPPORTED AND AMPLIFIED BY BILL
CAPPAGIANIS.
TODAY WE'LL FOCUS ON ORGANIZED
MEETING HELD AT THE END OF JUNE,
KEY PART OF THE LARGER
CONTINUING EFFORT AT NIH TO
EXPLORE AND EXPAND RESEARCH AND
OPPORTUNITIES IN THIS SPACE.
NEXT SLIDE PLEASE.
A CORE PLANNING GROUP WAS
ASSEMBLED WHICH THEN RECEIVED A
GREAT RESPONSE WHEN WE FORMED
THE NIH HIV AND PHARMACY
PLANNING GROUP.
TO DATE AS YOU SEE THERE'S A
TOTAL OF TEN NIH ICOS
PARTICIPATING, AND WE WOULD LIKE
TO POINT OUT AND THANK OUR NIAID
REPRESENTATIVES AND TAKE THE
OPPORTUNITY TO RECOGNIZE TODAY'S
MEETING HERE, THE NIH OFFICE OF
AIDS RESEARCH ADVISORY COUNCIL
MEMBER DR. ANN KNEELEN, THE
LIAISON.
THIS WAS THE LOGO AND TITLE OF
THE MEETING HELD VIRTUALLY OVER
TWO DAYS ON JUNE 28 AND 29 WITH
OVER 300 PARTICIPANTS, OVER 40
SPEAKERS.
SPEAKERS AND ATTENDEES
REPRESENTED A DIVERSE SWATH FROM
ACROSS THE U.S. GOVERNMENT,
COMMUNITY, ACADEMIC, BUSINESS
SECTORS.
SPEAKERS AND OTHER MEETING
PARTICIPANTS WERE SELECTED BY
THE PLANNING GROUP, SPECIFICALLY
FOR THEIR INVOLVEMENT AND
EXPERIENCE IN THE AREAS OF HIV,
PHARMACY SPACE, IN MOST CASES
BOTH.
NEXT SLIDE PLEASE.
THE OVERALL STRUCTURE AND
SESSIONS OF MEETING ARE
REPRESENTED ON THIS SLIDE.
BEGINNING WITH A STAGE SETTING
OPENING PLENARY FOLLOWED BY
FOCUS ON COMMUNITY INTERESTS,
MEETING WAS ORGANIZED BY THE
FOUR APPROACHES LISTED HERE AND
A PANEL PRESENTATION DISCUSSION
FORMAT FOR EACH.
CLOSING SESSION INCLUDING
MEETING SUMMARY REPORT-OUT BY
DR. EL-NAHAL.
I TURN THE PODIUM OVER TO HIM TO
PROVIDE MORE DETAIL ABOUT
DISCUSSIONS AND OUTCOMES WHICH
WE'VE UPDATED FOR THE PURPOSES
OF YOUR MEETING TODAY.
DR. EL-NAHAL?
>> THANK YOU, PAUL.
HI.
I'M WALID EL-NAHAL, AAAS FELLOW,
NIH OFFICE OF AIDS RESEARCH, AND
I SERVED AT THIS MEETING IN
JUNE.
I'LL TAKE YOU THROUGH THE
HIGHLIGHTS AND SUMMARIZE KEY
TAKEWAYS, FIRST AN OUTLINE.
I'M GOING TO TALK ABOUT
POTENTIAL OF PHARMACIES TO
PROVIDE HIV SERVICES, A KEY
COMPONENT OF LOTS OF TALKS THAT
HAPPENED AT THIS MEETING.
I'LL GO OVER EXIST MOMENTUM
WHICH IS DEMONSTRATED AT THE
MEETING FROM JUST A VERY LARGE
GROUP OF DIVERSE INTERESTED
PARTIES FROM ALL SORTS OF
SECTORS.
I'M GOING TO BRIEFLY SAMPLE SOME
CURRENT RESEARCH LANDSCAPE WE
HEARD ABOUT AT THE MEETING IN
JUNE, AND I'LL TRANSITION INTO
TALKING ABOUT BARRIERS TO HIV
SERVICES DELIVERED IN PHARMACIES
AND PIVOT TO WE'VE TALKED ABOUT
BARRIERS, WHAT THEN IS THE NEED
FOR FUTURE RESEARCH TO TRY AND
ADDRESS SOME OF THOSE BARRIERS
AND LASTLY I'LL HAND IT OVER TO
MIKE TO TALK ABOUT SOME
OPPORTUNITIES MOVING FORWARD IN
THIS INITIATIVE.
FIRST, FROM THE MEETING IN JOIN,
I'LL OPEN TALKING ABOUT
POTENTIAL OF PHARMACIES TO
PROVIDE HIV SERVICES, SUMMARIZED
IN THIS WORD CLOUD GENERATED ON
THE DAY OF THE MEETING BY
PARTICIPANTS THEMSELVES, WHEN
ASKED ABOUT KIND OF WHY YOU
THINK PHARMACIES HAVE VALUE AS
AVENUE FOR DELIVERING HIV
SERVICES, THESE WERE SOME WORDS.
I'LL HONE IN ON THE BIGGEST
WORD, IN THE CENTER, ACCESS
WHICH REALLY SUMMARIZES THIS
WELL.
AND, AGAIN, LOTS OF SPEAKERS ON
THE DAY OF MEETING TALKED ABOUT
THAT.
THE REASON WE BELIEVE PHARMACIES
ARE AN OPPORTUNITY TO INCREASE
ACCESS IS BECAUSE THERE'S 60,000
PHARMACIES ACROSS THE UNITED
STATES, 90% OF THE U.S.
POPULATION LIVES WITHIN FIVE
MILES OF THE COMMUNITY PHARMACY.
THIS MAP WAS PRESENTED AND
RECENTLY PUBLISHED AT THE
MEETING IN JUNE.
BASICALLY DEMONSTRATES THE BLUE
DOTS ON THE MAP DEMONSTRATE THE
SIGNIFICANT NUMBER OF PHARMACIES
AVAILABLE AND HOW THEY ARE
WIDELY SPREAD ACROSS THE MAP,
COMPARED TO SOME TRADITIONAL
YELLOW TRIANGLES, PrEP
PRESCRIBING LOCATIONS,
PHARMACIES FAR OUTNUMBER OTHER
AVENUES THROUGH WHICH WE'VE
DELIVERED CARE.
NOT JUST DOMESTICALLY, LEFT IS
ATLANTA, RIGHT IS SUB-SAHARAN
AFRICA.
WE HEARD FROM SPEAKERS THERE ARE
THOUSANDS OF PHARMACIES IN
UNDERSERVED AREAS PRESENTING
OPPORTUNITY TO MITIGATE SOME
HEALTH DISPARITIES WE'VE BECOME
FAMILIAR WITH.
THEY ALSO AS A RESULT PRESENT AN
OPPORTUNITY TO ADDRESS
INEQUITIES, PHARMACIES ARE OPEN
LONG HOURS AND ACCESSIBLE AT
CONVENIENT HOURS.
THEY CAN BE COST EFFECTIVE.
ONE OF THE SPEAKERS MENTIONED
THAT FOR EACH DOLLAR SPENT ON
CARE DELIVERED THROUGH
PHARMACIES WE COULD POTENTIALLY
SAVE $3 ON THE BACK END FOR HIV
DIAGNOSIS, TREATMENT, AND CARE.
THERE'S ALSO OBVIOUSLY LESSONS
LEARNED FROM THE COVID-19
PANDEMIC.
WE'RE ALL FAMILIAR WITH THE IDEA
THAT PHARMACIES WERE A HUGE
SOURCE OF DELIVERING CARE DURING
THE PANDEMIC THROUGH DELIVERY OF
MILLIONS AND MILLIONS OF
VACCINATIONS, AS WELL AS
MILLIONS OF TESTS.
WE WANT TO TAKE THOSE
OPPORTUNITIES AND LEARN FROM
THEM AS RELATES TO HIV WHICH
WAS, AGAIN, A FOCUS OF SOME OF
THE TALKS AT THE MEETING.
SO, THAT WAS JUST A BRIEF
OVERVIEW OF HOW SOME PRESENTERS
TALKED ABOUT WHY THERE'S SO MUCH
POTENTIAL IN THIS SPACE.
WHAT I WANT TO DO NEXT IS
DEMONSTRATE AMOUNT OF MOMENTUM
THERE IS FOR PHARMACY-BASED HIV
SERVICES, CAPTURED BY THE FACT
THERE WERE SO MANY FOLKS FROM
VARIOUS SECTORS TALKING ABOUT
THIS WORK AND DOING WORK IN THIS
AREA.
ONE NOTED 15 STATES AUTHORIZED
PHARMACIST PRESCRIPTION OF
PrEP AND PEP, INCLUDED IN THE
NATIONAL STRATEGY WHICH HAROLD
SPOKE ABOUT AT THE MEETING.
U.S. PUBLIC HEALTH SERVICES WAS
AT THE MEETING AND SPOKE ABOUT
EHE PHARMACY TASK FORCE.
WE HEARD DURING THE MEETING IN
JUNIPER SPECK ACTIVES OF
ADVOCATES, THE COALITION HOSTED
A ROUNDTABLE AND IN ATTENDANCE
AS WELL.
AND WE SAW PRESENTED THIS
GROWING LITERATURE ON PHARMACIES
FOR HIV CARE, CULMINATING IN THE
MEETING IN JUNE TO SUMMARIZE THE
RESEARCH.
THE TAKEAWAY FROM THE LAST SLIDE
IS THAT WE HAVE FOLKS FROM
FEDERAL GOVERNMENT, STATE
GOVERNMENT, ACADEMIA, INDUSTRY,
THE COMMUNITY ALL VERY INVESTED
IN THIS WORK AND WORKING TO TRY
AND ADVANCE IT.
SO THE NEXT THING I'LL DO IS GO
OVER SOME OF THE CURRENT
RESEARCH LANDSCAPE, THIS IS NOT
MEANT TO BE COMPREHENSIVE.
IT'S REALLY JUST THE SAMPLING WE
GOT AT THE MEETING FROM THE
VARIOUS PRESENTERS WHO SPOKE ON
TOPICS OF RESEARCH AND THE WORK
THEY ARE DOING IN THIS AREA.
SO DURING THE MEETING IN JUNE WE
GOT TO SEE QUALITATIVE DATA THAT
DEMONSTRATED INTEREST FROM
PATIENTS, WILLINGNESS FROM
PHARMACISTS TO PROVIDE SERVICES.
WE SAW PILOTS, MULTI-CENTER
STUDIES DEMONSTRATING SUCCESSFUL
TESTING OF HUNDREDS OF
PARTICIPANTS FOR HIV, INCLUDING
SOME POPULATIONS THAT REALLY
HISTORICALLY ARE UNDERTESTED,
WHICH MEANS COULD SUGGEST IT'S A
GREAT WAY TO REACH NEWER
POPULATIONS.
WE SAW EXAMPLES OF
COLLABORATIONS BETWEEN ACADEMIA,
COMMUNITY AND RETAIL PHARMACIES,
OVER A RANGE OF DIFFERENT
HIV-RELATED SERVICES AND
PROGRAMS.
WE SAW GREAT EXAMPLES OF
PHARMACIES BEING LEVERAGED AS A
MEANS DELIVERING PrEP,
SPEAKING TO THE POINT RAISED
EARLIER, CORNER PHARMACY
OFFERING COUNSELING, TESTING,
PRESCRIPTION.
WE SAW MULTI-DISCIPLINARY WORK
WITH TEAMS INCLUDING NURSE
NAVIGATORS, PHARMACISTS, REMOTE
PHYSICIANS TO INCREASE PrEP
ACCESS.
IN RURAL COMMUNITIES WE SAW
EXAMPLE OF TELEPrEP STUDIES TO
EXTEND REACH AND COVERAGE OF
PrEP TO FOLKS WE HAVEN'T
HISTORICALLY ENGAGED WELL
OTHERWISE.
WE ALSO SAW INVESTIGATIONS OF
PHARMACIES AS AVENUE FOR
LONG-ACTING THERAPY FOR HIV
WHICH AGAIN TO THE POINT BROUGHT
UP EARLIER WE KNOW HAS BEEN A
CHALLENGE FOR LOTS OF CLINICS TO
ADMINISTER AND PATIENTS TO
ACCESS.
WE SAW TRAINING PROGRAMS FOR
PHARMACISTS IN MEDICATION
MANAGEMENT TO INCREASE
PROPORTION OF VIRALLY SUPPRESSED
PEOPLE LIVING WITH HIV.
AND WE SAW PROGRAMS FROM LARGE
RETAIL PHARMACIES IN ADDITION
SMALLER COMMUNITY PHARMACIES,
THAT SOUNDED LIKE IT WAS
DOMESTIC BUT WE SAW GREAT WORK
INTERNATIONALLY, AGAIN PILOTS
AND TRIALS OF DRUG DISPENSING
OUTLETS TO FACILITATE
SELF-TESTING AMONG YOUNG WOMEN
IN TANZANIA AND PrEP DELIVERY
PATHWAYS IN KENYA.
THAT WAS A WHIRLWIND AND I
COVERED A LOT OF STUDIES AND
LISTED WAYS PHARMACIES HAVE BEEN
USED TO DELIVER CARE BUT THE BIG
PICTURE TAKEAWAY FROM THE MANY
PRESENTATIONS WE HAD DURING THE
MEETING WAS THAT WHEN YOU'RE
THINKING ABOUT THIS SPACE OF HIV
AND PHARMACY AS A MEANS OF
DELIVERING SERVICES THERE'S
RESEARCH DESIGNED DIVERSITY, WE
SAW TRIALS, PILOTS, QUALITATIVE
RESEARCH, OBSERVATIONAL STUDIES,
OUTCOME DIVERSITY, FOLKS LOOKING
AT TREATMENT, LOOKING AT PrEP,
LOOKING AT COMORBIDITIES, TARGET
POPULATION AND GEOGRAPHIC
DIVERSITY AS I MENTIONED, WORK
BEING DONE DOMESTICALLY AND
INTERNATIONALLY.
AND THANKFULLY THERE'S A BROAD
RANGE OF COLLABORATORS FROM
ACADEMIA TO COMMUNITY TO HEALTH
DEPARTMENTS SO A LOT OF INTEREST
AND A LOT OF ENGAGEMENT.
THE BIG SUMMARY WAS THAT THERE'S
A GROWING BODY OF DATA THAT
SUGGESTS PHARMACY-BASED HIV
SERVICE DELIVERY IS OF INTEREST
TO PATIENTS, HIGHLY FEASIBLE,
IT'S EFFECTIVE FOR REACHING
HIGHER PROPORTION OF THE
POPULATION, COST AND TIME
EFFECTIVE, COULD BE USED TO
MITIGATE STIGMA AND CAN INCLUDE
PREVENTION, DIAGNOSIS,
TREATMENT, AND OTHER SERVICES
THAT ARE GAINING INCREASED
ATTENTION LIKE MANAGEMENT OF
COMORBIDITIES FOR PEOPLE LIVING
WITH HIV.
I TALKED ABOUT THE WORK THAT'S
BEEN DONE, SOME SUCCESSES WE'VE
SEEN IN THIS SPACE.
THROUGHOUT THE MEETING WE ALSO
HEARD VARIOUS BARRIERS TO
DELIVERING HIV CARE IN
PHARMACIES.
LOTS OF THESE WERE THREADED
THROUGHOUT PRESENTATIONS, I'LL
LIST THEM THAT CAME UP
REPEATEDLY?
JUNE.
TALK OF ISSUES OF SCOPE OF
PRACTICE WHICH VARIES FROM STATE
TO STATE FOR PHARMACISTS.
ISSUES RELATED TO WORKFORCE
TRAINING.
ISSUES OF SCALABILITY AND
SUSTAINABILITY OF INTERVENTIONS.
ISSUES RELATED TO REIMBURSEMENT
FOR SERVICES.
ISSUE OF PHARMACY DESERTS, I
MENTIONED PHARMACIES ARE WIDELY
AVAILABLE BUT NOT EVERYWHERE, OF
COURSE.
WE HEARD ABOUT BARRIERS TO
IMPLEMENTING BARRIERS TO TEGS ON
SITES, PROMOTING HEALTHY
BEHAVIORS, LINKAGE TO CARE,
WORKFLOW INTEGRATION, PHARMACIST
BANDWIDTH, A LONG LIST OF
BARRIERS, SO YOU WOULD TAKE EACH
OF THOSE AND THINK IF YOU'RE
LOOKING FROM RESEARCH
PERSPECTIVE HOW DO I TURN A
BARRIER INTO A RESEARCH QUESTION
THAT IF WE ADDRESS ALLOWS US TO
OVERCOME THAT BARRIER, SO WE DID
THAT EXERCISE AT THE END OF THE
MEETING AND I'LL GO THROUGH THAT
AND LIST EACH BARRIER AND
BRIEFLY THINK OF THE BIG PICTURE
RESEARCH QUESTIONS THAT WOULD BE
ASSOCIATED WITH THAT IF WE
ADDRESSED COULD POTENTIALLY
SURMOUNT SOME OBSTACLES TO
DELIVERING CARE THIS WAY.
STARTING WITH IMPLEMENTATION,
HOW DO YOU BEST IMPLEMENT
PHARMACY-BASED INTERVENTIONS AND
THINK ABOUT THE FACT THE CONTEXT
DIFFERS FROM WALMART OR
WALGREEN'S TO A SMALL COMMUNITY
PHARMACY, THEY HAVE DIFFERENT
LEVELS OF RESOURCES, DIFFERENT
STAFFING, DIFFERENT COMMUNITIES
THEY SERVE SO THAT CONTEXT IS
IMPORTANT AND HOW DOES
IMPLEMENTATION VARY.
TESTING, HOW DO YOU THINK ABOUT
NEWER TECHNOLOGIES AND MAKE SURE
WE'RE MAKING IT AS EASY AS
POSSIBLE TO TEST ON SITE AND
BETTER LEVERAGE TESTING
TECHNOLOGIES WE ALREADY HAVE.
WHEN IT COMES TO PROMOTING
HEALTHY BEHAVIORS, HOW CAN WE
USE BEHAVIORAL AND SOCIAL
SCIENCE TO SUPPORT
PHARMACY-BASED INTERVENTION,
MAKE SURE THESE INTERVENTIONS
ARE BEING DONE IN A WAY THAT
CENTERS POPULATION WE'RE
INTERESTED IN PROVIDING CARE FOR
AND ENGAGES THEM AS PARTNERS TO
MAKE SURE IT'S COMMUNITY DRIVEN
AND ADDRESSING THEIR NEEDS, NOT
ONLY ACCEPTABLE BUT ENTICING TO
USE THESE SERVICES.
NEXT IS THE ISSUE OF LINKAGE TO
CARE.
WHAT'S THE BEST WAY TO MAKE SURE
THE CARE ISN'T JUST STOPPING AT
DING OR DIAGNOSIS BUT WE'RE
LINKING SOMEONE TO CARE TO
CONTINUE TO GET TREATMENT, SO
HOW DO YOU BUILD PARTNERSHIPS
BETWEEN PHARMACIES AND HEALTH
DEPARTMENTS OR THE CLINICS THAT
ARE GOING TO BE PROVIDING
LONG-TERM CARE FOR FOLKS?
WORKFLOW INTEGRATION, A LOT OF
SERVICES ARE ALREADY OFFERED.
IF THIS ISN'T DONE EFFICIENTLY
IT WILL OVERWHELM THE FOLKS
INVOLVED WHICH BRINGS ME TO THE
LAST POINT OF PHARMACIST
BANDWIDTH, SUPPORTING THE
PHARMACISTS DOING THIS WORK.
REMAINING, FIRST SCOPE OF
PRACTICE, A COMPLICATED QUESTION
THAT CAME UP MULTIPLE TIMES.
THE SCOPE OF PRACTICE VARIES
ACROSS STATE TO STATE.
AGAIN WITHOUT ADVOCATING FOR ANY
POLICIES AS A FEDERAL GOVERNMENT
EMPLOYEE I'M GOING TO MENTION
THIS TOPIC OF WHAT POLICIES CAN
FACILITATE THAT WORK NEEDS TO BE
LOOKED@.
AND WHAT IS SCOPE OF
PHARMACISTS, JUST FOCUSED ON
VIRAL SUPPRESSION OR THINGS LIKE
COMORBIDITIES, MANAGEMENT OF
MENTAL HEALTH, OF SUBSTANCE USE
DISORDER AND HOW CAN WE LEVERAGE
THEM.
HOW DO WE TRAIN A TEAM?
AND THE ISSUE THAT PHARMACIES
ARE DIFFERENT ACROSS THE COUNTRY
IN AMOUNT OF RESOURCES THAT ARE
DIFFERENT, HOW DO WE SCALE
ACROSS LOCAL CONTEXTS.
THE NEXT POINT IS ISSUE OF
REIMBURSEMENT WHICH CAME UP OVER
AND OVER, WHAT IS COST
EFFECTIVENESS OF DELIVERING
INTERVENTION THIS WAY AND HOW
DOES THAT TIE TO REIMBURSEMENT.
THE POINT MADE IF THESE SERVICES
ARE NOT REIMBURSED IT'S GOING TO
BE DIFFICULT TO SUSTAIN THEM.
PHARMACIES ARE GEOGRAPHICALLY
WIDELY PRESENT BUT THERE IS THE
ISSUE THAT NOT EVERY PLACE HAS A
CLOSE ACCESS TO PHARMACY EVEN
THOUGH A LOT DO.
THAT'S JUST ONE DIMENSION OF THE
BROADER ISSUE OF HOW DO WE THINK
ABOUT SOCIAL DETERMINANTS OF
HEALTH AND MAKE SURE WE'RE
INCORPORATING THEM INTO THIS
RESEARCH IN A WAY THAT MITIGATES
DISPARITIES AND OUTCOMES WE'RE
SEEING AND HOW CAN PHARMACIES --
HOW CAN WE LEVERAGE PHARMACIES
TO DO THAT.
LASTLY I'LL MOVE INTO MY QUICK
SUMMARY.
PHARMACY-BASED HIV SERVICES HAVE
TREMENDOUS POTENTIAL TO IMPROVE
HEALTH.
PEOPLE FROM MANY SECTORS ARE
VERY MOTIVATED TO ADVANCE THIS
WORK.
VERY TALENTED PEOPLE ARE
STUDYING AND IMPLEMENTING THIS
ALREADY.
AND THE BODY OF LITERATURE
AROUND IT IS GROWING, REALLY
PROVING ITS VALUE.
BUT THERE'S PLENTY OF ROOM TO
GROW AND SEVERAL BARRIERS TO
OVERCOME.
SO THE QUESTION WE POSE TO THE
AUDIENCE IN JUNE, HOW CAN WE ALL
IN OUR RESPECTIVE ROLES HELP
OVERCOME BARRIERS, AND WHEN WE
TURN INTERNALLY AT THE NIH HOW
CAN WE HELP FOSTER RESEARCH TO
ANSWER THOSE QUESTIONS I PUT ON
THE BOARD AND OVERSOME THESE
ISSUES.
I'LL PASS IT TO MIKE TO TALK
ABOUT THE NEXT STEPS.
>>
>> I'M MIKE STIRRATT, PLEASED TO
PARTNER ON THE CO-CHAIRING OF
OUR HIV AND PHARMACY PLANNING
COMET.
SINCE OUR TIME IS TIGHT WE'LL
MENTION BRIEFLY SOME OF THE NEXT
STEPS FOR OUR PLANNING
COMMITTEE.
WE'RE WORKING RIGHT NOW ON
GETTING THE VIDEO POSTED FROM
OUR TWO-DAY MEETING IN JUNE, SO
THAT'S AVAILABLE TO THE PUBLIC.
THAT SHOULD BE AVAILABLE VERY
QUICKLY.
WE'RE ALSO TALKING ABOUT
OPPORTUNITIES TO DO A MEETING
SUMMARY THAT WE'LL PUBLISH AND
EFFORT TO COLLABORATE ON A
SPECIAL ISSUE JOURNAL SUPPLEMENT
THAT WOULD HIGHLIGHT WORK IN THE
PHARMACY SPACE,
PHARMACY-DELIVERED HIV TESTING
AND PrEP.
WE'RE PLEASED TO HAVE NIAID AS
OUR PARTNERS FROM THE VERY
BEGINNING, AND NIAID HAS
RECENTLY ISSUED A NUMBER OF
ADMINISTRATIVE SUPPLEMENTS
THROUGH EHE FUNDING WHICH ARE
SET TO PURCHASE PILOT PROJECTS
AND DELIVERY OF SERVICES THROUGH
PHARMACISTS AND PHARMACIES, A
GREAT PLATFORM TO BUILD ON FOR
FUTURE RESEARCH INITIATIVE.
WE LOOK FORWARD TO TAKING THESE
EFFORTS FORWARD IN THE FUTURE.
WORK IN HIV HAS BENEFITED FROM
COLLABORATION, THIS IS A
COLLABORATIVE EFFORT, AND WE'RE
GRATEFUL FOR THE PLANNING GROUP,
THANK YOU FOR THE CONTRIBUTIONS
AND HANG YOU TO THE ARAC TO
PRESENT THIS.
THERE'S PROMISE AND POTENTIAL
FOR RESEARCH TO SCALE, SPEED,
STRENGTHEN PHARMACIST AND
PHARMACY-DELIVERED PrEP AND
CARE.
AND LOOK FORWARD TO WORKING WITH
YOU ON THAT FRONT.
THANK YOU.
>> THANK YOU FOR SHARING THIS
INCREDIBLY IMPORTANT WORK WITH
US.
AND FOR THE TAG TEAM
PRESENTATION.
WE DON'T HAVE TIME FOR QUESTIONS
UNFORTUNATELY BUT IF YOU STAY
AROUND DURING THE BREAK I'M SURE
MANY PEOPLE WANT TO CHAT WITH
YOU.
THERE'S NOTHING TO VOTE ON.
WE'RE GOING TO MOVE TO TWO NEW
CONCEPTS, AND WE'RE STARTING
WITH GERARD LACOURCIERE
PRESENTING ONLINE ON STRATEGIES
FOR ELIMINATING HIV PROTEIN.
>> CAN YOU HEAR ME?
>> YES.
>> OKAY.
I'M PRESENTING TODAY FOR
APPROVAL MY CONCEPT, STRATEGIES
FOR ELIMINATING HIV PROTEINS.
NEXT SLIDE PLEASE.
THIS ONE-TIME INITIATIVE IS
DEVELOPMENT OF MOLECULES THAT
TARGET HIV PROTEINS, OR RNA FOR
DEGRADATION OR INTERFERE WITH
TRANSLATION INTO PROTEIN.
WHILE UNPROVEN, THIS NEW TYPE OF
DRUG HAS POTENTIAL TO ELIMINATE
HIV PROTEINS THAT HAVE PROVEN
DIFFICULT TO TARGET VIA
TRADITIONAL DRUG DISCOVERY
METHODOLOGIES, A NEW INITIATIVE,
PROPOSING GRANT MECHANISM,
METHOD OF SOLITICATION AN RFA,
PROPOSING BOTH R21 AND R01
GRANT, TWO TO FIVE YEARS,
ESTIMATED BUDGET OF $2 MILLION,
ANTICIPATING TO FUND BETWEEN
FOUR TO FIVE AWARDS.
NEXT SLIDE.
CURRENT DRUGS USED TO CONTROL
INFECTION BLOCK ACTIVITY OF
ENZYMES CRITICAL TO VIRAL LIFE
CYCLE INCLUDING REVERSE
TRANSCRIPTATION, INTEGRASE,
PROTEASE, BLOCKED DIFFUSION OF
VIRUS THROUGH HOST CELL
RECEPTORS, STRATEGIES MAY BE
SUCCESSFUL TARGETING ALL HIV
PROTEINS, THIS INITIATIVE SEEKS
TO APPLY NEW THERAPEUTIC
STRATEGIES THAT ARE CAPABLE OF
TARGETING ALL HIV PROTEINS.
THIS CAN BE ACHIEVED BY THE
TARGETED DEGRADATION OF PROTEINS
OR ENCODING RNA OR DEVELOPMENT
OF SMALL MOLECULES THAT PREVENT
PROCESSING.
WE'LL REMOVE BIOLOGICAL
FUNCTIONS OF THE TARGETED
PROTEIN, MAY OVERCOME RESISTANCE
AND DRUG TOXICITY.
THIS CAN BE EXPANDED TO HIV
TARGETS WHICH HAVE BEEN
DIFFICULT TO INHIBIT.
NEXT SLIDE.
SO ONE INTRACELLULAR PRO
PROTEIN CAN BE REMOVED CAN BE
ACCOMPLISHED WITH A SMALL
MOLECULE, PROTEOLYSIS TARGETING
CHIMERA, BIFUNCTIONAL MOLECULE,
PROTEIN OF INTEREST, SECOND
LIGAND TARGETS UBIQUITINATION
PATHWAY, WHEN INTERNALIZED,
PROTEIN OF INTEREST IS PRESENT,
AS WELL AS E3 LIGASE, IT WILL
UBIQUINATE PROTEIN OF INTEREST,
DIRECTED TO PROTEASOME, REMOVING
IT FROM THE CELL.
NEXT SLIDE.
PROTEIN DEGRADATION IS AN
EXPANDING AREA OF THERAPEUTIC
DEVELOPMENT.
IT'S BEEN SHOWN TO BE EFFECTIVE
STRATEGY FOR TARGETING
UNDRUGGABLE PROTEINS.
MULTIPLE PROTACS HAVE BEEN
DEVELOPED AND REPORTED FOR
ONCOLOGY, AUTOIMMUNE
INFLAMMATION, AND
NEURODEGENERATIVE TARGETS.
THERE IS AT LEAST ONE
PUBLICATION THAT I'M AWARE OF,
ONE ANTI-VIRAL PROTAC THAT'S
BEEN DEVELOPED, THIS ONE WAS
TARGETING PROTEASE OF THE
HEPATITIS C VIRUS.
PROTEIN DEGRADATION IS AN AREA
OF INTEREST IN BIG PHARMA AND
BIOTECH, AND IN REVIEW THAT CAME
OUT A COUPLE YEARS AGO, IT WAS
REPORTED THAT THERE WERE 15
PROTACs IN CLINICAL
DEVELOPMENT, FOCUSED ON ONCOLOGY
AND AUTOIMMUNE TARGETS.
EARLIER THIS YEAR ONE OF THESE
MOLECULES TRANSITIONED TO PHASE
3, PROTAC WHICH IS BEING
DEVELOPED, MOVING CLOSER TO
LICENSED PRODUCT.
THERE IS THE CLINICAL AND
REGULATORY PATHWAY ESTABLISHED,
AND THESE TYPE OF MOLECULES ARE
FORMULATED FOR ORAL DELIVERY.
SO, PROTACs HAVE BEEN AROUND
FOR 20 YEARS.
THEY ARE THE MOST WIDELY KNOWN
AND WIDELY USED PROTEIN
DEGRADATION PLATFORMS.
NEXT SLIDE.
IN THE LAST FEW YEARS THERE HAVE
BEEN NEW PLATFORMS DEVELOPED AND
REPORTED WHICH ALSO ARE CAPABLE
OF DEGRADING CELLULAR PROTEIN.
I'LL HIGHLIGHT TWO ADDITIONAL
PLATFORMS, FIRST IS AUTACs,
SIMILAR TO WHAT I JUST DESCRIBED
WITH THE PROTAC, A LIGAND THAT
TARGETS CELLULAR PRODUCT,
CONNECTED TO A LINKER, BUT THIS
LIGAND WILL RECRUIT COMPONENT OF
THE AUTOPHAGOSOMAL PATHWAY TO
TARGET DEGRADATION OF CELLULAR
COMPONENTS, SHOWN TO BE
EFFECTIVE IN DEGRADING PROTEINS,
ONE EXAMPLE IT WAS ABLE TO
DEGRADE ORGANELLE, SPECIFICALLY
BIND TO DYSFUNCTIONAL
MITOCHONDRIA AND DEGRADE IT.
ANOTHER PLATFORM WHICH HAS BEEN
REPORTED THAT CAN DEGRADE
CELLULAR PROTEINS IS A LYTAC,
THIS PLATFORM IS USED TO DEGRADE
MEMBRANE BOUND PROTEINS, THE
EXAMPLE IN THE FIGURE A FULL
LENGTH ANTIBODY WHICH TARGETS
EITHER INTRACELLULAR PROTEIN OR
MEMBRANE-BOUND PROTEIN
CONJUGATED TO LINKER, CONTAINING
A LIGAND WHICH BINDS TO LYSOSOME
RECEPTOR, INTERACTS WITH THE
LYSOSOME TARGETING RECEPTOR TO
BECOME INTERNALIZED, SENT TO THE
LYSOSOME DEGRADED.
THERE'S AN EXAMPLE HOW THIS WAS
EFFECTIVE IN DEGRADING THE PD-L1
RECEPTOR ON THE CELL SURFACE.
YOU CAN TAR TARGETS RNA.
RIBOTAC IS SIMILAR, I WILLING
AND -- A LIGAND AT ONE END, THE
SECOND LIGAND RECRUITS RNA,
CELLULAR RNA.
IF THE RNA IS PRESENT IN THE
CELL, SMALL MOLECULE BINDS IT
WAS DELIVER RNAASE AND DEGRADE
IT, PROTEIN WILL NOT BE
TRANSLATED.
THERE ARE OTHER STRATEGIES WHICH
CAN TARGET RNA FOR DEGRADATION
SUCH AS siRNA OR CAS13.
IT WAS SUCCESSFUL IN DEGRADING
NON-CODING RNA, MAINRY LY
microRNA 21, ALSO DEGRADATION
OF SARS-COV-2.
SO, IN ADDITION TO TARGETING RNA
FOR DEGRADATION, RNA CAN BE
TARGETED WITH SMALL MOLECULES OR
NUCLEOTIDE BASED THERAPY TO
PREVENT RNA PROCESSING, SPLICING
OR TRANSLATION.
THIS EXAMPLE SHOWN HERE, IT'S
FOCUSED ON PROTEIN
ALPHA-SYNUCLEIN, UPREGULATED IN
DEVELOPMENT OF PARKINSON'S
DISEASE, LONG BEEN CONSIDERED
THERAPEUTIC TARGET.
THE PROTEIN HAS NOT BEEN ABLE TO
BE INHIBITED WITH SMALL
MOLECULES, SO WHAT THIS PAPER
SHOWED WAS A SMALL MOLECULE WAS
DEVELOPED, BINDS TO THIS
STRUCTURAL ELEMENT PRESENT IN
THE FIVE PRIME UNTRANSLATED
REGION OF THE mRNA BEFORE THE
START CODON, FOUND WHEN THIS IS
BOUND IN THIS PART OF THE
STEM-LOOP IT BLOCKS RIBOSOME
FROM MOVING FORWARD AND
TRANSLATING PROTEIN.
EVEN THOUGH RNA IS PRESENT, THE
SMALL MOLECULE BLOCKS
TRANSLATION OF THE RNA INTO
PROTEIN AND ESSENTIALLY NO
PROTEIN IS MADE.
SO SMALL MOLECULES THAT TARGET
RNA ARE ALSO AN INTEREST TO BIG
PHARMA AND SMALL BIOTECHS, I
WANT TO HIGHLIGHT IN 2020 THE
FDA APPROVED FIRST SMALL
MOLECULE WHICH TARGETS RNA,
EVRYSDI USED IN TREATMENT OF
SPINAL MUSCULAR ATROPHY.
NEXT SLIDE.
SO, WHAT WE WANT TO ACCOMPLISH,
WE WOULD LIKE TO SUPPORT
PROJECTS THAT DESIGN, OPTIMIZE,
STRATEGIES FOR TARGETING HIV
PROTEINS, RNA THAT ENCODES THEM
FOR DEGRADATION.
SUPPORT SMALL MOLECULE PROJECTS
THAT INTERFERE WITH PROCESS IN
TRANSCRIPTION AND TRANSLATION,
THAT TARGET HOST CELL PROTEINS
IF PRE-VALIDATED HIV DEPENDENCY
FACTORS, ESSENTIAL FOR HIV
REPLICATION, SUPPORT TECHNOLOGY
DEVELOPMENT SPECIFICALLY FOCUSED
ON HIV TARGET, AND ALSO SUPPORT
PROOF OF CONCEPT STUDIES IN HIV
INFECTED CELLS IN SMALL ANIMAL
MODELS.
APPLICATIONS PROPOSING ANY OF
THE FOLLOWING RESEARCH TOPICS
WILL NOT BE SUPPORTED, ANIMAL
MODELS USING NON-HUMAN PRIMATE,
AND THIS INITIATIVE WILL NOT
SUPPORT CLINICAL TRIALS.
NEXT SLIDE.
SO WHERE DOES THIS FIT?
FOCUSED ON DRUG DISCOVERY, FITS
WELL INTO THE BASIC RESEARCH
PORTFOLIO.
EXPECTATION WOULD BE THAT AS
COMPOUNDS ARE DEVELOPED THEY
WOULD MOVE, PROGRESS TOWARDS
PRE-CLINICAL AND CLINICAL
CANDIDATES, SO IT'S RIGHT AT THE
CUSP OF BASIC RESEARCH AND
TRANSLATIONAL RESEARCH.
THERE HAVE BEEN SOME OTHER
AWARDS OR PROGRAMS ISSUED OVER
THE YEARS, WHICH ARE SIMILAR TO
WHAT I'M PROPOSING, ALL OF THEM
HAVE EXPIRED AND THERE ARE NO
ACTIVE PROGRAMS TO SUPPORT THIS
TYPE OF WORK AT THE MOMENT.
NEXT SLIDE.
SO, PRE-ARAC REVIEWERS, DR.
HARRIS AND DR. JEROME, I THANK
THEM FOR THEIR TIME AND FEEDBACK
IN DEVELOPING THIS INITIATIVE.
AT THE MEETING THEY RECOMMENDED
APPROVAL OF THIS PROPOSED
INITIATIVE.
I WILL JUST GO THROUGH SOME
COMMENTS MADE DURING THE REVIEW,
AND OUR RESPONSE TO THEM.
IT MIGHT BE USEFUL TO SPECIFY
WHETHER YOU INTEND siRNA OR
CASS 13 OR OTHER MECHANISMS TO
BE CONSIDERED RESPONSIVE.
YES, WE'LL CONSIDER TO BE
RESPONSIVE.
IF YOU FAVOR SMALL ANIMAL MODELS
SINCE THIS FIELD IS RELATIVELY
NEW IT MAY BE USEFUL TO CLARIFY.
YES, LIMITED TO SMALL ANIMAL
MODELS AS PROOF OF CONCEPT.
CITE/LIST PRECEDENCE FOR
PROTACs, DURING MY
PRESENTATION I DID NOT INCLUDE
REFERENCE FOR THE PROTAC
GENERATED AGAINST HEPATITIS C
PROTEASE PROTEIN.
I DID INCLUDE IT IN THIS TALK.
AND THE RESPONSE TO THE GENERAL
QUESTION, I DON'T HAVE A GOOD
ANSWER.
IT IS A GAP THAT WE ALSO SEE IN
TERMS OF HIV THERAPEUTIC
DEVELOPMENT, THAT'S ONE OF THE
REASONS I'M PROPOSING THIS
INITIATIVE IS TO STIMULATE MORE
INTEREST IN DEVELOPING THESE
TYPE OF THERAPEUTICS.
NEXT SLIDE.
IN ADDITION TO SMALL MOLECULES
CONSIDER TARGETING WITH ODN OR
NUCLEIC ARSED BASED THERAPIES,
YES.
RESEARCH MAY INCLUDE TECHNOLOGY
DEVELOPMENT IF FOCUSED ON HIV
TARGETS, WE AGREE AND WILL BE
WRITTEN TO INCLUDE TECHNOLOGY
DEVELOPMENT.
AND RESEARCH MAY INCLUDE
CELLULAR TARGETS IF BONE A FIGHT
HIV DEPENDENCY FACTORS ESSENTIAL
FOR HIV REPLICATION, AND WE
AGREE AND THE RFA WILL ALLOW
HOST TARGETS IF PRE-VALIDATED AS
ESSENTIAL FOR HIV REPLICATION.
NEXT SLIDE.
AND THIS IS MY FINAL SLIDE.
>> EXCELLENT.
THANK YOU SO MUCH.
THE PRESENTATION IS OPEN FOR
QUESTIONS.
>> THAT'S REALLY INTERESTING AND
NOVEL.
MONICA GANDHI, UCSF.
THAT'S NOVEL IN TERMS OF
THERAPEUTIC TARGETS BUT YOU
MENTIONED THE QUESTION
PHARMACEUTICAL COMPANIES
INTERACTING, WOULD THIS BE
SOMETHING YOU ENVISION A GROUP
IN ACADEMIA DOES WITH A
PHARMACEUTICAL COMPANY, AND IF
SO IS IT SBIR OR SOMETHING?
>> I'LL CONSIDER THAT.
THANK YOU.
>> ARE THERE OTHER QUESTIONS?
>> JUST A COMMENT.
RUBEN HARRIS.
WELL SUMMARIZEED, GERARD.
THANK YOU.
>> THANKS.
>> ANY QUESTIONS ONLINE?
>> KEITH JEROME, ONE OF THE
REVIEWERS.
I WANT TO SAY THAT, GERARD, THIS
IS VERY RESPONSIVE TO COMMENTS
WE HAD.
I'LL MAKE THE POINT THAT TO
REITERATE, I THINK THIS IS A
REALLY PROMISING APPROACH, AND
VERY IMPORTANT COMPLEMENT,
FILLING A GAP IN THE CURRENT
PORTFOLIO, AN AREA THAT SHOULD
BE RESEARCHED, IT'S JUST NOT
BEING ADDRESSED RIGHT NOW.
>> WITH THAT COMMENT, I'LL URGE
EVERYBODY TO PLEASE VOTE.
AND WE'LL THANK YOU.
WE'LL MOVE TO THE NEXT
PRESENTATION.
>> BRING THE MIC CLOSER.
>> THIS IS LIMITED INTERACTION
TARGETED EPIDEMIOLOGY, LITE.
TRANSMISSION AND TREATMENT AMONG
VULNERABLE POPULATIONS IN LATIN
AMERICA, LITE-LA.
THE PURPOSE IS TO SUPPORT STATUS
NEUTRAL RESEARCH TO IMPROVE
PREVENTION AND TREATMENT IN
LATIN AMERICA BY USING REMOTE
METHODS TO ENROLL, TEST, FOLLOW
NEGATIVE PERSONS OR VULNERABLE
AND PEOPLE LIVING WITH HIV NOT
LIKELY TO BE VIRALLY SUPPRESSED,
FOCUSING ON PERSONAL AND
STRUCTURAL FACTORS IMPACTING HIV
ACQUISITION OR AMONG PEOPLE WITH
HIV, HIV VIREMIA, IDENTIFYING
SUBGROUPS AND HOT SPOTS WITH
INCREASED RISK, ADDRESSING A GAP
IN KNOWLEDGE THOSE MOST
VULNERABLE TO ACQUIRING, THE
GRANTEES RECEIVE TWO YEARS OF
FUNDING TO DEVELOP LARGE COHORTS
AND THEN MEET MILESTONES IN
TERMS OF RECRUITMENT AND NUMBER
OF PEOPLE WHO SEROCONVERT.
IF THEY ARE SUCCESSFUL THEY GET
ADDITIONAL THREE YEARS OF
FUNDING.
NIAID FUNDING FOR $2 MILLION, WE
EXPECT 1 TO 2 AWARDS.
NIMH, NICHD AND NIDA SUPPORTED
THE LITE INITIATIVES IN THE
UNITED STATES IN THE PAST,
HOPING THEY WILL COME BACK IN
FOR THIS ONE AS WELL.
THE PROBLEM IS IN LATIN AMERICA
GLOBALLY THIS IS DATA FROM 2010
TO 2020, GLOBALLY THERE'S BEEN A
NICE DECLINE IN INCIDENCE OF
HIV, OVER TIME, OVER THAT TIME
PERIOD, BUT IN CONTRAST IN LATIN
AMERICA THERE'S BEEN INCREASE IN
HIV INCIDENCE, I WAS ABLE TO GET
THIS DATA HOT OFF THE PRESSES,
FOR GOING FROM 2010 TO 2022,
LET'S SEE IF I CAN USE THIS
MOUSE HERE.
YEAH.
WE CAN SEE IN TERMS OF NOW TWO
YEARS MORE, WE HAVE AN 8%
INCREASE IN HIV INCIDENCE IN
LATIN AMERICA.
AND THAT'S IN CONTRAST TO 38%
DECREASE IN GLOBAL, WHICH IS
DRIVEN BY THESE HETEROSEXUAL
EPIDEMICS IN AFRICA, REALLY
SUCCESSFUL REDUCTION IN HIV
INCIDENCE.
BUT THE LATIN AMERICAN EPIDEMIC
WHICH I WOULD POINT OUT HAS
TWICE AS MANY CASES AS EUROPE
AND NORTH AMERICA PUT TOGETHER,
IS REALLY A HOMOSEXUAL EPIDEMIC,
NOT HETEROSEXUAL.
I NEED TO POINT OUT A QUARTER OF
CASES IN LATIN AMERICA ARE
OCCURRING IN WOMEN NOT
HOMOSEXUAL, WHO ARE
HETEROSEXUAL, AND THREE-QUARTERS
IN MANY WHO HAVE SEX WITH MEN,
THAT'S ILLUSTRATED OVER HERE.
WE'RE ABOUT HALF OF THE CASES
AMONG MSM.
SMALL PROPORTION AMONG
TRANSGENDER WOMEN.
THERE'S RED GROUP, WHICH IS
PARTNERS OF THE AFFECTED GROUPS,
THIS IS THE WOMEN.
IT HAS TO BE THE WOMEN.
IF THEY WERE MEN THEY WOULD BE
OVER THERE IN THE GOLD SECTION.
AND SO WHAT'S HAPPENING IS
THERE'S MSM IN A HIGHLY
STIGMATIZED POPULATION WHO ARE
HAVING SEX WITH MEN AND ALSO
WITH WOMEN, AND THESE WOMEN ARE
BASICALLY UNAWARE OF THE FACT
THEY ARE AT RISK.
SO THIS IS A VERY HARD GROUP TO
FIND BECAUSE THEY DON'T EVEN
KNOW THEY ARE AT HIGH RISK OF
HIV.
BUT WE CAN FIND THIS GROUP.
SO THE QUESTION IS THE EPIDEMIC
LIKE LOOKS THE UNITED STATES
EXCEPT IN THE UNITED STATES
WOMEN CONSTITUTE 7% OF THE
ANNUAL CASES.
AND WE'VE BEEN SUCCESSFUL IN THE
UNITED STATES ROLLING OUT PrEP
AND ROLLING OUT THERAPY, GETTING
PEOPLE TO U EQUALS U,
UNDETECTABLE QUALITIES
UNTRANSMITTIBLE, THIS ISN'T
HAPPENING IN LATIN AMERICA.
PrEP STUDIES HAVE SHOWN
VIRTUALLY NONE OR ZERO USE IN
MOST COUNTRIES.
AND ALSO IN TERMS OF VIRAL
SUPPRESSION, IT'S BEEN SMALL
INCREASES OVER TIME, ABOUT 20%
OF PEOPLE LIVING WITH HIV DON'T
KNOW THEY HAVE HIV, ANOTHER 15%
KNOW THAT THEY HAVE IT BUT ARE
NOT ON THERAPY.
OVERALL 40% OF PEOPLE LIVING
WITH HIV ARE NOT SUPPRESSED.
SO, IN THE LIFE STUDIES, THIS IS
THE ORIGINAL THREE STUDIES, FOUR
FUNDED UNDER THE FIRST LITE.
GRANTEES THE SHOW SUCCESS IN
FINDING HIGHLY VULNERABLE MEN
WHO HAVE SEX WITH MEN,
TRANSGENDER WOMEN, USING THESE
GAY DATAING APPS WIDELY USED IN
THE UNITED STATES, ALSO WIDELY
USED IN LATIN AMERICA.
GRINDR IS THE NUMBER ONE.
GRANTEES IN LITE 1 THAT USE THE
DATING APPS TO ACCUMULATE THE
NUMBER OF PARTICIPANTS, FOR
EXAMPLE STUDYING 5,000 USING
GRINDR AND OTHER DATING APPS,
FOUND 11% THAT DEVELOPED OVER
FOUR YEARS, HIGHER INCIDENCE IN
BLACKS VERSUS LATINOS AND
WHITES, HALF OF THE
SEROCONVERSIONS WERE PEOPLE WHO
USE METH.
RENDINA USED THE GRINDR AND APPS
TO ACCUMULATE CASES, SCREENED
14,000 THROUGHOUT THE UNITED
STATES AND PUERTO RICO.
LOWER NUMBERS OF INFECTIONS,
STILL SUBSTANTIAL, SAME RACIAL
DIFFERENCES.
THE WIRTZ AND REISNER STUDY USED
CLINICS FOR HALF OF SUBJECTS, ON
THE EAST COAST AND IN THE SOUTH.
SOCIAL MEDIA BUT NOT THE DATING
APPS, FACEBOOK AND OTHER ONES,
LOWER NUMBER OF HIV
SEROCONVERSIONS, SHOWS
IMPORTANCE OF THESE GAY DATING
APPS IN TERMS OF FINDING HIGHLY
VULNERABLE PEOPLE, AND IT MAKES
SENSE.
YOU HAVE SOMETHING ON YOUR PHONE
THAT CAN FIND YOUR DATING
PARTNER FOR THE NIGHT AS EASILY
AS ORDERING PIZZA, IT MAKES
SINCE THIS IS FINDING PEOPLE
VERY MUCH AT RISK.
IN TERMS OF PAPERS THAT CAME OUT
OF THE FIRST GROUP OF LITE
STUDIES, I PLUGGED IN THE GRANT
NUMBERS FOR THREE GRANTS INTO
PubMed, AND PULLED OUT THE
PAPERS THAT WERE -- GENERATED, A
HOLD OF 86 IN THE FIVE-YEAR
PERIOD.
HERE WE'RE COMPARING PEOPLE WHO
SEROCONVERT TO THOSE WHO DON'T,
JUST THESE TWO, METH USE BY
GROVE AND THE OTHER IN THE
TRANSGENDER POPULATION, MAKES
SENSE BECAUSE OF COURSE YOU
CAN'T WAIT TO PUBLISH UNTIL ALL
YOU'VE ACCUMULATED ALL YOUR
CASES, THEY HAVE TO BE WORKING
FROM DAY ONE TO BE RE-FUNDED.
I THINK WHAT WAS KEY WAS THAT
USING THESE SOCIAL MEDIA AND
REMOTE METHODS WITH VERY LARGE
COHORTS, WORKING ALMOST IN REAL
TIME, I MEAN PARTICIPANTS ARE AN
E-MAIL AWAY FROM THE
INVESTIGATORS, AND SO THEY DID
QUITE A FEW STUDIES ON PrEP,
23% OF PAPERS DEALT WITH PrEP
INCLUDING THIS ONE THAT DEALT
WITH EFFECT ON PrEP USE IN THE
UNITED STATES THAT SWITCHED FROM
GILEAD FROM AND THERE WERE
LAWSUITS THAT SAID THEY ENGAGED
PEOPLE BY WITHHOLDING, A
CHILLING EFFECT ON USE OF PrEP
WHERE PEOPLE STOPPED USING IT OR
THEY DECIDED NOT TO USE IT
BECAUSE THEY THOUGHT IT WAS
DANGEROUS, NOT MANY PAPERS ON
TREATMENTS BUT LITE STUDIES,
THAT WAS NOT A FACTOR.
THEY WEREN'T FUNDED TO DO THAT.
AND I THINK THE ABILITY TO WORK
IN REAL TIME IS SHOWN IN THEIR
STUDIES OF COVID WHICH 41% OF
PAPERS DEALT WITH THE COVID
EPIDEMIC, BECAUSE THEY COULD
PIVOT ON A DIME AND NOW SWITCH
WHEN WE HAD THE PANDEMIC, BOTH
THE GROVE AND WIRTZ REISNER WERE
SUPPLEMENTED TO WORK WITH COVID,
AND NOW HE'S WORKING WITH Mpox
IN GAY POPULATIONS, LETS THEM
LOOK INTO THE WEEDS IN TERMS OF
YOU HAVE A LARGE NUMBER OF
PEOPLE AT HIGH RISK OF HIV AND
YOU CAN LOOK AT, YOU KNOW,
SUICIDE AND WHATEVER, THE LATIN
AMERICA INVESTIGATORS WILL NOW
BE ABLE TO FOCUS ON TREATMENT
AND CONDUCT PREVENTION OR
BEHAVIORAL CLINICAL TRIALS,
THOSE WERE NOT ALLOWED UNDER
FIRST LITE STUDIES.
SO ARE THESE DATING APPS
AVAILABLE IN LATIN AMERICA?
AND THEY ARE.
I MEAN, THIS STUDY ENROLLED
56,000 PEOPLE, 18 COUNTRIES.
AND THEY HAVE BEEN ABLE TO
ENROLL SEXUAL AND GENDER
MINORITIES, JUST HAVE BEEN
SUCCESSFULLY USED, ALSO IN LATIN
AMERICA.
WHAT ARE THE QUESTIONS THEY CAN
ANSWER, PREVENTION QUESTIONS?
IT'S REALLY BASICALLY WHAT ARE
THE SUBGROUPS OF MSM AND
TRANSGENDER PEOPLE WITH HIGHEST
VULNERABILITY, ROLE OF SUBSTANCE
USE, IS THAT A FACTOR IN LATIN
AMERICA, WE DON'T KNOW.
WHAT ABOUT ALCOHOL?
DO SPECIFIC PRACTICES INCREASE
VULNERABLE, CONDOM USE, WHAT
ABOUT SEX WORK, HIV INCIDENCE IN
INCARCERATED POPULATIONS, HOW
ABOUT CAB-LA IMPACT USE?
WHAT IS LENGTH OF TIME FROM HIV
DIAGNOSIS TO VIRAL SUPPRESSION?
WHY ARE SOME MSM AND TRANSGENDER
PEOPLE LESS LIKELY TO BE
RETAINED IN CARE AND SUPPRESSED,
WHAT'S THE ROLE OF ALCOHOL AND
SUBSTANCE USE, WHAT ARE
STRUCTURAL FACTORS ASSOCIATED
WITH POOR RETENTION AND VIRAL
SUPPRESSION, WHAT'S EFFECT OF
COST, OF POVERTY, HOW CAN NEW
AND REVISED TREATMENT PROGRAMS
IMPROVE RETENTION AND VIRAL
SUPPRESSION.
THE RFA REQUIREMENTS ARE
SIMILAR, REQUIRED TO DEVELOP
LARGE, MORE THAN 5,000 PEOPLE,
COHORTS, CONTACTED REMOTELY AND
THEY HAVE HIGHLY VULNERABLE TO
HIV, IT'S LIKELY THAT MSM OR
TRANSGENDER PEOPLE WILL BE
STUDIES BUT THIS COULD FUND
STUDIES OF COMMERCIAL SEX
WORKERS AND LOOK AT WOMEN BUT
THEY WOULD HAVE TO FIND A WAY TO
FIND LARGE NUMBERS AND FIND
THOSE MOST AT RISK OF HIV.
THE GRANTEES WOULD BE REQUIRED
TO DEVELOP INNOVATIVE METHODS OF
DIGITAL ENROLLMENT, REMOTE
TESTING AND FOLLOW-UP, AS IT'S
MILESTONE DESIGNED WHERE THEY
HAVE TO MEET INITIAL MILESTONES
FOR RETENTION AND ACCUMULATING
PARTICIPANTS AND HIGH RISK IN
TERMS OF SEROCONVERSION TO GET
THE SECOND PHASE OF FUNDING,
AFTER TWO YEARS TO GET THE LAST
THREE YEARS.
GRANTEES WILL BE REQUIRED TO
REFER PARTICIPANTS TESTING HIV
POSITIVE TO CARE AND CONTINUE
FOLLOW-UP TO DOCUMENT RETENTION
AND CARE IN VIRAL SUPPRESSION.
THIS IS NOT DONE IN THE ORIGINAL
LITE STUDIES, AND CONDUCT
EPIDEMIOLOGY STUDIES.
REVIEWERS WERE D'AQUILA AND
SHACKLEFORD, THIS IS CRITICALLY
IMPORTANT TO BEGIN STUDY OF HIV
AND VIREMIA RISK GIVEN TRENDS
ARE GOING THE WRONG WAY, LITE
APPROACH IS SMART GIVEN EARLIER
SUCCESS.
THEY WOULD NOTE ADD REQUIREMENT
FOR ENROLLING SPECIFIC RACES AND
ETHNIC GROUPS BUT INVESTIGATORS
SHOULD ENROLL ACROSS RACES
INCLUDING INDIGENOUS AND BLACK
PARTICIPANTS.
THE AMERICAN LITES REQUIRED 50%
MINORITY, AND THAT'S NOT BEING
DONE HERE.
BUT WE AGREE IT'S A GOOD IDEA,
AT LEAST TO ENCOURAGE PEOPLE,
EVEN REQUIRE INVESTIGATORS TO
ENROLL ACROSS RACES, ALSO ACROSS
SES STATUS, THAT HAS BEEN SHOWN
THAT LOWER INCOME IS ASSOCIATED
WITH HIGHER RISKS OF HIV.
IT'S IMPORTANT TO REQUIRE
IN-COUNTRY INVESTIGATOR TO BRING
KNOWLEDGE OF CULTURE AND LOCAL
RISK GROUPS AND MEDICAL CARE
ACCESS IN INDIGENOUS PEOPLES.
REALLY IT WOULD BE NICE IF THE
INVESTIGATORS SPOKE SPANISH OR
PORTUGUESE, AND WE AGREE WITH
THE REVIEWERS AND RFA WILL
REQUIRE IN-COUNTRY
CO-INVESTIGATORS WHERE
PARTICIPANTS ARE RECREATED.
SORRY.
CONSIDER IF THERE ARE
DIFFERENCES ACROSS COUNTRIES IN
PrEP ROLLOUT, ART ACCESS, ART
SUPPRESSION, OF VIREMIA SET THE
STAGE FOR STUDYING CORRELATES OF
BETTER SUCCESS, WE CAN MAKE THIS
A REVIEW CRITERIA, APPLICANTS
REQUIRED TO JUSTIFY INCLUDING
PARTICIPANTS FROM COUNTRIES
BASED ON HIV INCIDENCE, PrEP
ROLLOUT, ANOTHER COMMENT IF
SMARTPHONE APPS AND/OR CELL DATA
ACCESS ARE TO BE USED ENSURE
THERE ARE WAYS BUILT INTO THE
STUDY PLAN TO ENABLE
PARTICIPANTS TO MAINTAIN
CONSISTENT SMARTPHONE DATA PLAN
ACCESS, ALTERNATIVE TECHNOLOGY
USING DUMB PHONE, I LOVE THAT,
ACCESSIBLE TEXTING MIGHT BE
CONSIDERED.
LEVELS OF SMARTPHONE OWNERSHIP
ARE HIGH, THE USE OF GAY DATING
APPS HAS WORKED PREVIOUSLY.
THOSE WERE CROSS-SECTIONAL
STUDIES.
LONGITUDINAL STUDIES WILL BE
HARDER, INVESTIGATORS SHOULD
OUTLINE PLANS AND ALTERNATE
PLANS IF ORIGINAL APPROACH
FAILS.
RETENTION IS UH3 MILESTONE.
ANOTHER COMMENT WAS THAT UG3/UH3
MECHANISM IS A PLUS, FLEXIBILITY
IS ENCOURAGED TO ADAPT RETENTION
STRATEGIES.
NIH WILL NEGOTIATE MILESTONES
BEFORE FUNDING TO ENSURE THEY
ARE REASONABLE.
UG3/UH3 MECHANISM ALLOWS NIH TO
FUND INNOVATION BUT NOT BE
OBLIGATED TO A FAILING PROJECT.
LITE EXPERIENCE HAS BEEN THAT AT
THE NIH PROGRAM OFFICERS CAN
WORK WITH THE GRANTEES AND -- I
MEAN PROGRAM OFFICERS FROM
CO-FUNDING INSTITUTES CAN WORK
WITH GRANTEES TO MAKE MILESTONES
FEASIBLE AND DURING INITIAL
PHASE COLLABORATION BETWEEN
INVESTIGATORS AND THE NIH STAFF
CAN GUIDE THEM TO SWITCH
APPROACHES QUICKLY FOR SUCCESS.
AND THEN THE FINAL COMMENT ON
EVALUATING -- SORRY ABOUT THAT.
EVALUATING LONG ACTING PrEP IS
ENCOURAGED, GIVEN STUDIES WILL
BE STARTING CLOSE TO WHEN THIS
ROLLS OUT AND THERE MAY BE
DIFFERENCES IN ACCESS/COST
COMPARED TO UNITED STATES AND
MAYBE ACROSS LATIN AMERICA.
SO WE ABSOLUTELY WILL DO THIS AS
MUCH AS WE CAN ENCOURAGE STUDIES
OF CAB-LA WE WILL DO IT.
ONE PROBLEM THAT THIS MAP SHOWS
COUNTRIES, 90 COUNTRIES AGREED
TO PROVIDE LOWER COST PrEP
FOR, IN TERMS OF LONG ACTING
CAB-LA.
YOU CAN SEE ONLY THREE COUNTRIES
IN SOUTH AMERICA AND CENTRAL
AMERICA ARE INCLUDED, BOLIVIA,
HONDURAS, EL SALVADOR.
$23,000 IN THE UNITED STATES,
HOPEFULLY WON'T BE FUNDED UNTIL
2025 TO 2030, HOPEFULLY COSTS
WILL COME DOWN, AS THESE NEW
LONG-ACTING MEDICINES ARE
APPROVED.
I'LL STOP HERE SINCE I'VE
ALREADY TALKED ABOUT THIS, AND
TAKE QUESTIONS.
>> THANK YOU VERY MUCH.
NOW OPEN FOR QUESTIONS.
>> AUDREY PETTYFOR, UNC.
I HAVE A DOCTORAL STUDENT AT
UNC, IN THE LITE I COHORT, ONE
OF THEM, LOOKING AT STATE LEVEL
DISCRIMINATORY POLICIES, HOW
IT'S IMPACTED PrEP UPTAKE,
THERE'S MORE COMING PROBABLY
FROM EVEN THE FIRST ONE AND I
THINK THE GEOGRAPHIC DIVERSITY
THAT THE ONLINE PLATFORM OFFERS
DOES ALLOW FOR SORT OF
MULTI-LEVEL STATE LEVEL, AND I
WONDER IN LATIN AMERICA SIMILAR
THINGS WITH THE RISE OF
DISCRIMINATORY POLICIES, WITH
THE POLITICAL CLIMATE GLOBALLY
NOW.
I THINK IT'S A REALLY IMPORTANT
PLATFORM TO MEASURE AND TRACK
HOW THAT'S IMPACTING PREVENTION
AND ACCESS TO CARE.
>> IT ALLOWS, IF THERE'S A SMALL
SUBGROUP, ALLOWS PEOPLE TO
ACCUMULATE ENOUGH PARTICIPANTS,
FOR EXAMPLE THE WOMEN'S STUDY TO
GO WIDE TO HAVE ENOUGH PEOPLE IN
THE COHORT, REALLY AN ADVANTAGE.
AND NO LIMITS FOR GEOGRAPHY
BECAUSE EVERYTHING IS DONE
REMOTELY.
>> I THINK THIS IS GREAT, OTHER
ONES IN THE UNITED STATES HAVE
BEEN SUCCESSFUL BUT MY QUESTION
WAS IT'S ALMOST LIKE YOU'RE
COMBINING LITE AND LITE-VS, THIS
WOULD BE ACROSS THE ENTIRE
SPECTRUM, EITHER NEGATIVE OR
PEOPLE LIVING WITH HIV, SEEMS
LIKE -- WELL, MOBILE VENUES, BUT
SEEMS LIKE THIS COULD BE HARD
BECAUSE YOU HAVE TO LINK THEM
INTO CARE DIFFERENTLY.
>> BUT THEY WILL HAVE PEOPLE WHO
SEROCONVERT, CONTINUING TO
FOLLOW UP TO SEE WHAT HAPPENS,
HOW LONG IT TAKES TO GET INTO
CARE, FIND A WAY TO MEASURE
VIRAL SUPPRESSION REMOTELY.
AND THEN TALK ABOUT WHAT THE --
THEY WILL HAVE INCIDENT CASES TO
FOLLOW OVER TIME.
PRETTY POWERFUL DESIGN.
AND WE JUST FELT THAT THE
PROBLEM IN LATIN AMERICA IS NOT
JUST PREVENTION, IT'S REALLY
TREATMENT AS WELL.
I SHOWED THAT SLIDE THAT WE NEED
TO ADDRESS BOTH IF IT'S
POSSIBLE.
AND I THINK IT WILL.
>> OTHER QUESTIONS?
>> LOUIS SHACKLEFORD, HVCN.
LEVEL OF REPRESENTATION IS
AMAZING, HAPPY I GOT CHANCE TO
BE PART OF IT IN TERMS OF
REVIEWING AND IT'S AN AMAZING
PROGRAM.
I REALLY APPRECIATE YOU BRINGING
THIS TO THE TABLE.
>> THANK YOU.
THANK YOU FOR BEING A REVIEWER.
APPRECIATE YOUR COMMENTS.
>> THIS IS RICH D'AQUILA, I'D
LIKE TO SECOND WHAT LOUIS SAID.
THANK YOU FOR BEING RESPONSIVE
TO OUR COMMENTS AS WELL, GERALD.
>> OH, THAT'S RICHARD.
OKAY, THANK YOU.
>> ONE COMMENT, WHETHER YOU
CONSIDERED MIGRANT POPULATIONS
AS WELL?
>> YOU MEAN IN THE UNITED
STATES?
>> NO, IN LATIN AMERICA.
>> WITHIN LATIN AMERICA?
>> YEAH.
>> I MEAN, IT'S UP TO THE
INVESTIGATORS BUT THEY CAN FIND
THEM.
THEY HAVE CELL PHONES.
MONICA TALKED ABOUT THE HOMELESS
GUYS HAVING SMARTPHONES, THEY
ARE OUT THERE, GIVES A WAY FOR
PEOPLE TO CONTACT PEOPLE.
>> OKAY.
IF THERE ARE NO OTHER QUESTIONS,
THANK YOU VERY MUCH.
I'LL ASK EVERYBODY TO VOTE.
AND THEN WE HAVE A 15-MINUTE
BREAK FOR EVERYBODY ONLINE AS
WELL.
AND WE'LL ASK YOU TO BE BACK AT
2:40.
PLEASE VOTE BEFORE YOU GO HAVE
COFFEE.
>>I'M KRISTEN PORTER, PROGRAM
OFFICER, PREVENTION SCIENCES
PROGRAM, SORRY I COULDN'T BE
THERE IN PERSON WITH YOU ALL
TODAY.
ON BEHALF OF THE GRIP TEAM I'M
INTRODUCING THE FUNDING CONCEPT.
GRIP STANDS FOR GENDER AFFIRMING
HORMONE THERAPY, RESILIENCE,
IMMUNOLOGY, PHARMACOKINETICS.
OBJECTIVE TO SUPPORT CRITICAL
RESEARCH NEEDED TO INFORM
STRATEGIES TO PREVENT AND TREAT
HIV AND OTHER SEXUALLY
TRANSMITTED INFECTIONS IN
TRANSGENDER PEOPLE.
THERE ARE MANY MEDICAL AND
SURGICAL INTERVENTIONS THAT
TRANSGENDER PEOPLE UNDERGO AS
PART OF GENDER AFFIRMATION THAT
MIGHT IMPACT THE ACQUISITION AND
TREATMENT OF HIV OR OTHER STIS.
DESPITE A GROWING BODY OF DATA,
FEW STUDIES ADDRESSED THESE
ISSUES IN THIS POPULATION, THIS
IS A NEW REQUEST FOR FUNDING
ANNOUNCEMENT, R01 EXCLUDING
CLINICAL TRIALS, FIRST YEAR
COSTS APPROXIMATELY $2 MILLION,
DURATION FIVE YEARS, WE EXPECT
TO FUND TWO TO THREE AWARDS,
NATIONAL INSTITUTES OF CHILD
HEALTH AND DEVELOP THE, NATIONAL
INSTITUTE OF MENTAL HEALTH, AND
NATIONAL INSTITUTE OF DRUG ABUSE
ARE POTENTIAL PARTNERS.
NEXT SLIDE PLEASE.
WHY SUPPORT HIV RESEARCH IN
TRANSGENDER INDIVIDUALS?
APPROXIMATELY 1.6 MILLION PEOPLE
IN THE UNITED STATES IDENTIFY AS
TRANSGENDER.
9.2% ARE HIV POSITIVE.
VERSUS .5% OF THE UNITED STATES
POPULATION AS A WHOLE.
ACCORDING TO SPECIAL REPORT BY
THE CDC, 42% OF TRANSGENDER
WOMEN ARE LIVING WITH HIV.
AS TRANSGENDER MEN AND WOMEN ARE
DISPROPORTIONATELY BURDENED BY
HIV, THERE'S A CLEAR NEED TO
UNDERSTAND IF BIOLOGICAL FACTORS
ARE PLAYING A ROLE.
NEXT SLIDE.
TO BEGIN TO UNDERSTAND HOW
GENDER AFFIRMING CARE MAY IMPACT
HIV, A SMALL NUMBER OF R21 IN
RESPONSE TO PREVENTION AND
TREATMENT OF HIV AND STIS.
NINE AWARDS MADE, SEVEN BY
DAIDS, 2 BY DMID.
THIS TABLE WE'VE LISTED R21
INVESTIGATORS WITH SCIENTIFIC
RESEARCH AREAS.
THESE AWARDS DEMONSTRATED
RECIPIENTS HAD ACCESS TO
TRANSGENDER POPULATIONS FOR
RESEARCH BUT AS THE R 21s
AWARDED RESULTS HAVE YET TO BE
PUBLISHED.
NEXT SLIDE PLEASE.
HOWEVER, WE'VE INCLUDED TWO
FIGURES FROM RECENT PUBLICATIONS
FOR RESEARCHERS CONDUCTING
SIMILAR STUDIES.
PANEL ON THE LEFT, YOU SEE
THERE'S A STATISTICALLY
SIGNIFICANT INCREASE IN THE
RECTAL TISSUE OF CIS AND
TRANSGENDER WOMEN COMPARED TO
MSM COUNTERPARTS.
RIGHT PANEL STUDY MEASURING
CONCENTRATIONS OF TENOFOVIR,
ACTIVE METABOLITE IN DRIED BLOOD
SPOTS, INDICATING VARIABILITY IN
DRUG LEVELS BETWEEN CIS AND
TRANSGENDER MEN AND WOMEN,
TRANSGENDER MEN HAVE HIGHER DRUG
LEVELS THAN TRANSGENDER WOMEN.
NEXT SLIDE PLEASE.
THE FOLLOW-UP IN JULY OF 2022 WE
HOSTED A WEBINAR WITH R21
RECIPIENTS TO HEAR UPDATES ON
RESEARCH AND GAPS THAT REMAIN
FOR HIV PREVENTION IN
TRANSGENDER PEOPLE.
HIGHLIGHTED IMPORTANCE OF
ENGAGING COMMUNITY AND PROVIDED
FEEDBACK FOR FUTURE INITIATIVES.
IN ADDITION TO THE WEBINAR WE
SOLICITED INPUT BROADLY FROM
SERVICE PROVIDERS FOR FOLLOW-UP
DISCUSSIONS WITH OUR TEAM.
TWO OF THE RESPONDENTS INCLUDED
WHITMAN WALKER CLINIC AND YOUTH
PRIDE CLINIC AT CHILDREN'S
NATIONAL HOSPITAL.
COMMON THEME, GENDER AFFIRMING
THERAPY IS A CONCERN, AND DRUG
INTERACTIONS THAT MAY IMPACT,
WHETHER ANTIRETROVIRALS FOR
PrEP OR HIV TREATMENT,
ACKNOWLEDGED BY ADVOCACY GROUPS
HIGHLIGHTING LACK OF RESEARCH
DATA ON DRUG-DRUG INTERACTION,
EFFECT ON PrEP EFFICACY, AN
EXAMPLE SHOWN HERE, THE AVAC
MANIFESTO.
IN THE STRATEGIC PLAN TO ADVANCE
RESEARCH ON HEALTH AND
WELL-BEING OF SEXUAL AND GENDER
MINORITIES, AIMS TO ADVANCE
RESEARCH FOR THESE POPULATIONS,
COLLABORATIONS BETWEEN
INTRAMURAL AND EXTRAMURAL
RESEARCHERS, FORMATION OF
PARTNERSHIPS WITH COMMUNITY
STAKEHOLDERS.
THE FIELD COMMUNITY ADVOCACY
GROUPS AND NIH HAVE DEEMED
TRANSGENDER BIOMEDICAL RESEARCH
A PRIORITY.
NEXT SLIDE PLEASE.
BASED ON FEEDBACK FROM THE
COMMUNITY, ADVOCACY GROUPS AND
LIMITED AVAILABLE INFORMATION IN
LITERATURE, IMPORTANT GAPS
REMAIN FOR HIV PREVENTION AND
CARE FOR TRANSGENDER PEOPLE.
SOME OF THESE GAPS PROGRAM
IDENTIFIED INCLUDE NEED FOR
BASIC UNDERSTANDING OF EFFECTS
OF GENDER AFFIRMING HORMONES ON
HIV SUSCEPTIBILITY AND CHANGES
IN MUCOSAL SCIENCE OF
TRANSMISSION, SAFETY, EFFICACY
AND PK STUDIES OF
ANTIRETROVIRALS IN PRESENCE OF
GENDER-AFFIRMING HORMONES.
UNDERSTANDING DRUG-DRUG
INTERACTIONS BETWEEN GENDER
AFFIRMING HORMONES AND
ANTIRETROVIRALS FOR TREATMENT
AND PREVENTION OF HIV AND
CO-INFECTIONS, INCLUDING LONG
ACTING MODALITIES.
RESEARCH TO UNDERSTAND IMPACT OF
POTENTIAL GENDER-AFFIRMING
HORMONE AND PrEP INTERACTION,
AND NEED FOR STUDY MODELS TO
EVALUATE GENDER-AFFIRMING
HORMONE AND ANTIRETROVIRALS,
INCLUDING ANIMAL, IN VITRO, EX
VIVO, IN SILICO MODELS.
NEXT SLIDE PLEASE.
TO ADDRESS THESE GAPS PROGRAM
HAS IDENTIFIED RESEARCH AREAS OF
INTEREST TO BE INCLUDED IN THE
GRIP RFA.
RESEARCH AREAS OF INTEREST
INCLUDE IMPACT OF GENDER
AFFIRMING HORMONE THERAPY IN
ADULTS OVER THE AGE OF 18, ON
PREVENTION AND TREATMENT OF HIV
AND/OR CO-INFECTIONS WITH OTHER
STIS.
THESE INTERESTS INCLUDE IMPACT
ON REGIMENS FOR PREVENTION OR
TREATMENT OF CO-INFECTION WITH
STI, STUDIES INCLUDING
METABOLISM AND DRUG-DRUG
INTERACTIONS.
DEVELOPMENT OF NEW ANIMAL, IN
VITRO, EX VIVO, AND IN SILICO
MODELS TO STUDY IMPACT OF GENDER
AFFIRMING HORMONES ON
IMMUNOLOGY, PHARMACOLOGY, SAFETY
EFFICACY OF HIV PREVENTION AND
TREATMENT REGIMENS AND/OR
CO-INFECTIONS WITH OTHER STIS.
IMPACT OF FEMINIZATION AND
MASCULINEIZATION REGIMEN ON GI
AND UROGENITAL MUCOSA, ROLE IN
HIV AND STI SUSCEPTIBILITY,
INFECTION, ACQUISITION.
HYPOTHESIS DRIVEN OMIC STUDIES
AND USE OF BIOLOGY TOOLS TO
CHARACTERIZE IMPACT OF THE
FEMINIZING AND MASCULINIZING
HORMONES ON HIV SUSCEPTIBILITY,
INCLUDING IN THE GI AND
UROGENITAL TRACTS.
STUDIES ON DETERMINATION OF
LEVELS OF GENDER AFFIRMING
HORMONES TO ADDRESS VARIATION
RELATED TO DIVERSE SOURCES OF
EXTERNAL HORMONES AND
PHYSIOLOGICAL AS WELL AS
PATHOPHYSIOLOGIC CONDITIONS.
NEXT SLIDE PLEASE.
PROGRAM APPRECIATES REVIEW AND
COMMENTS AND CONCERNS,
OVERARCHING COMMENTS INCLUDED
IT'S CRITICAL TO OBTAIN DATA TO
INFORM DECISION MAKING ON HIV
PREVENTION AND TRANSGENDER
PEOPLE ON GENDER AFFIRMING
HORMONE THERAPY.
IMPORTANCE OF STUDYING LONG
ACTING AS COMPARED TO DAILY
PrEP DOSING AND HOW HORMONES
MAY IMPACT COVERAGE OF DIFFERENT
PrEP REGIMENS.
IN THE ERA OF LONG-ACTING ART
AND PrEP, CISGENDER WOMEN MAY
DIFFER FROM MEN AND TRANSGENDER
WOMEN, SO IT'S IMPORTANT TO USE
THIS POPULATION AS CONTROLS.
MORE SPECIFIC CONCERNS ARE
INVESTIGATORS NEED TO KNOW
TYPES BEING TAKEN, ROUTE,
FORMULATION, DOSAGE, DOSING
SCHEDULE, MEASURING DRUG AND
HORMONE CONCENTRATION AS IT'S
IMPORTANT DUE TO VARIATION IN
THEIR STUDIES.
THE SOURCES OF HORMONES, WHETHER
PRESCRIBED, AS MAY SEEK HORMONES
OUTSIDE THE UNITED STATES, FOR
EXAMPLE.
THEY ALSO EMPHASIZE NEED FOR
BASIC RESEARCH INTO BIOLOGICAL
FACTORS THAT MAY INFLUENCE RISK,
SUSCEPTIBILITY, TRANSMISSION
AMONG TRANSGENDER PEOPLE.
NEXT SLIDE PLEASE.
TO ADDRESS CONCERNS PROGRAM WILL
ENCOURAGE APPLICANTS TO FOCUS ON
LONG ACTING PrEP MODALITIES
AND STUDIES THAT ASSESS EFFECTS
OF CHANGING PrEP OR GAHT
REGIMENS, CONSIDER APPROPRIATE
CONTROLS, INCLUDING CISGENDER
MEN AND WOMEN.
COLLECT INFORMATION ON THE TIMES
OF HORMONES BEING TAKEN, ROUTE,
FORMULATION, DOSAGE, DOSING
SCHEDULE, AND SOURCES OF
HORMONES MEASURING DRUG/HORMONE
CONCENTRATIONS.
AND INCORPORATE BASIC SCIENCE
RESEARCH INCLUDING OMICS STUDIES
TO FOCUS ON SUSCEPTIBILITY,
RISK, TRANSITION.
WITH THAT I'D BE HAPPY TO TAKE
QUESTIONS.
>> THANK YOU VERY MUCH.
ARE THERE ANY QUESTIONS IN THE
ROOM?
HOW ABOUT ONLINE?
NO?
NO QUESTIONS?
MONICA HAS A QUESTION.
GO AHEAD.
>> WE REVIEWED THIS BUT I DID
HAVE A QUESTION ABOUT
RESILIENCE, THE WORD BEING KEPT
IN THERE BECAUSE THAT WAS
CONFUSING.
I KNOW NIMH HAD SUPPORT BUT
THERE WAS NO ASPECT OF THIS THAT
WOULD INVOLVE QUALITATIVE
RESEARCH ABOUT RESILIENCE OR AT
LEAST AS ITS UNDERSTOOD
RESILIENCE, SO I WAS CURIOUS WHY
RESILIENCE WORD WAS KEPT IN
INSTEAD OF IMMUNOLOGY AND
PHARMACOKINETICS OUTCOMES.
>> EXCELLENT QUESTION.
YES, THAT WAS A WORD THAT WAS
CHOSEN BY OUR PARTNERS, BUT FOR
OUR PROGRAM, THAT TRANSGENDER
PEOPLE PRIORITIZE THEIR
GENDER-AFFIRMING HORMONES OVER
ANTIRETROVIRALS, OVER A LOT OF
OTHER DRUGS, DATA GENERATED FROM
THESE TYPES OF STUDIES ABOUT
GENDER-AFFIRMING HORMONES AND
ANTIRETROVIRAL INTERACTION MIGHT
ALLEVIATE CONCERNS
ANTIRETROVIRALS REDUCE
EFFECTIVENESS WHICH WOULD REDUCE
UPTAKE AND OVERALL
ANTIRETROVIRALS ACCEPTANCE.
>> WE BOTH AGREED THIS WAS
IMPORTANT.
ONE THING WE MENTIONED IS THAT
IT WOULD BE GREAT FOR NIH TO
SPONSOR A WORKSHOP, LONG-ACTING
CONTRACEPTION IN PEOPLE ON ART
AND WITH HIV, WE TALKED ABOUT
THIS.
THERE'S LIKE A LOT OF
INTERESTING RESEARCH GOING ON IN
THE PHARMACOKINETICS OF HOW
EXTERNAL HORMONES, HIV DRUGS,
AND, YOU KNOW, IMPACT SO I THINK
IT COULD BE LEARNED ACROSS
DIFFERENT POPULATIONS WOULD BE
IMPORTANT.
>> A WORKSHOP OR TWO IS IN THE
WORKS.
>> THANK YOU.
AND EVERYBODY, PLEASE VOTE.
AND WE'LL MOVE ON TO THE NEXT
PRESENTATION.
WHICH I BELIEVE WILL BE GIVEN BY
PATRICK JEAN-PHILIPPE,
POTENTIALLY FROM A CRUISE SHIP,
IF I'M NOT MISTAKEN.
>> NO, ACTUALLY FROM -- FIRST I
WANT TO MAKE SURE YOU'RE ABLE TO
SEE ME AND HEAR ME.
>> WE CAN SEE THE LOWER HALF OF
YOUR FACE.
>> OH, OKAY.
>> IF YOU COULD GET CLOSER TO
YOUR MICROPHONE IT COULD BE
BETTER.
>> ALL RIGHT.
SOMEHOW I'M NOT -- IS THAT
BETTER?
NO?
OKAY.
ALL RIGHT.
SO, WELL, THANK YOU, EVERYONE.
GREETINGS.
I WILL BE PRESENTING FOR YOUR
CONSIDERATION HOPEFULLY APPROVAL
THE INITIATIVE, LONG-ACTING DRUG
DELIVERY SYSTEMS FOR ART
OPTIMIZATION TO CHILDREN LIVING
WITH HIV, THE LADDS II
INITIATIVE.
NEXT SLIDE.
LADDS II PURPOSE TO ACCELERATE
DEVELOPMENT OF SAFE AND
EFFECTIVE LONG-ACTING DRUG
DELIVERY SYSTEMS FOR IMPROVED
SIMPLIFIED TREATMENT IN CHILDREN
AND THIS WILL STIMULATE
OPTIMIZATION AND EVALUATION OF
LADDS FORMULATIONS IN SUITABLE
PRE-CLINICAL ANIMAL MODELS, A
REISSUE, RENEWAL OF THE
MECHANISM, GRANT, R61/R33, AND
FIRST YEAR TOTAL COST OF $2
MILLION.
DURATION OF AWARD FIVE YEARS,
ANTICIPATE TO FUND THREE TO FOUR
AWARDS, TWO TO THREE MOVING TO
THE R33 PHASE.
AND WE ARE PARTNERING WITH NICHD
AND NIMH WHICH WILL BE OUR
PARTNERS IN THIS INITIATIVE.
NEXT SLIDE.
SO, WHY THIS IS NEEDED, SO THE
SLIDES DEPICTS LATEST 2022 DATA
ON STATE OF THE HIV EPIDEMIC IN
CHILDREN.
SUFFICE IT TO SAY STILL
UNACCEPTABLE IN PEDIATRIC
POPULATIONS, AND NUMBERS ARE
STAGGERING, 1.5, STILL 130,000
NEW INFECTIONS, 84,000 DEATHS.
IMPROVED BUT PACE OF IMPROVEMENT
IS SLOW.
NEXT SLIDE.
AND IN ADDITION TO THAT WE KNOW
THAT CURRENT VIRAL SUPPRESSION
RATES IN CHILDRENS ARE
SUBOPTIMAL, TREATMENT GAP, WE ON
THE GRAPH ON THE RIGHT UPPER
CORNER YOU CAN SEE THE LAST
GRAPHS DEPICT U.N. AIDS 2022
DATA IN CHILDRENS, AS PART OF
THE TREATMENT CASCADE TO
ACHIEVE, THE NUMBERS SPEAK FOR
THEMSELVES IN TERMS OF THE GAP
IN CHILDREN COMPARED TO OTHERS.
LOWER GRAPH WE CAN SEE THAT HOW
OF CHILDRENS, INFANT AND YOUNG
CHILDREN IN PARTICULAR, EVEN
LOWER, EVEN MORE EXPERIENCE
SUBSEQUENT VIRAL REBOUNDS.
YOU CAN SEE NICELY THE RATE OF
REBOUNDS REALLY INCREASE IN
CHILDRENS 0 TO 11 MONTHS, LESS
THAN 1 YEAR OF AGE.
NEXT SLIDE PLEASE.
AND SOME OF THE REASONS MAY HAVE
TO DO, KEY CONTRIBUTING FACTOR,
REGIMENS AVAILABLE TO CHILDREN,
THEY HAVE LIMITATIONS, THERE'S A
LOT OF -- SIGNIFICANT
PRE-TREATMENT DRUG RESISTANCE,
MANY SIDE EFFECTS, FORMULATIONS
IN CHILDRENS, EVEN WITH RECENT
STRIDES, SUBOPTIMAL, POOR
PALATABILITY COMPOUNDED BY
STIGMA AND PSYCHOSOCIAL NEEDS.
THERE'S ON THE HORIZON WITH
DOLUTEGRAVIR, IT'S AVAILABLE,
QUITE PROMISING, BUT LIKELIHOOD
IMPACT COULD STILL BE LIMITED BY
SOME FACTORS ABOVE.
WE NEED TO THINK ABOUT NOVEL
TREATMENT APPROACHES IN CHILDRE.
NEXT SLIDE.
AND SO LONG ACTING IS, YOU KNOW,
REPRESENT SIGNIFICANT
OPPORTUNITIES FOR PEDIATRIC HIV
TREATMENT, WE KNOW MAJOR ADVANCE
IN HIV TREATMENT, PROSPECT OF
ENHANCE TREATMENT, CONVENIENCE,
IMPROVED ADHERENCE, .
AND RANGING FROM EVERY TWO WEEKS
TO EVERY SIX MONTHS.
AND CAB-LA IS THE ONE APPROVED
FOR CHILDREN, ADOLESCENTS, AND
WE KNOW OPTIONS ARE BEING
DEVELOPED BUT AS USUAL IN
TRADITIONAL IT'S THE PEDIATRIC
DEVELOPMENT CONTINUES TO
SIGNIFICANTLY BE BEHIND
DEVELOPMENT, FURTHER WE KNOW
BENEFITS WILL BE SLOW TO EXTEND
TO YOUNGER PEDIATRIC POPULATIONS
WHICH WOULD BE THE LAST ONE TO
BENEFIT FROM THIS TREATMENT
INNOVATION SO WE REALLY NEED
INNOVATIVE TRANSMISSION
APPROACHES TO ACCELERATE CURRENT
AND FUTURE PEDIATRIC
POPULATIONS.
NEXT SLIDE PLEASE.
AND THE SCOPE AND AREA I'M GOING
TO GO OVER THOSE.
WE ANTICIPATE SUCCESSFUL
APPLICATION WE NEED TO PROPOSE
DELIVERY SYSTEM, KEY
CHARACTERISTICS, SHOULD BE
DEVELOPED FOR TARGETING
POPULATIONS LESS THAN 12 YEARS
OLD, SHOULD TAKE ADVANTAGE OF
ARRAY, EXPANDING ARRAY OF
TECHNOLOGY AVAILABLE, REGARDLESS
OF WHAT IT CHOOSES TECHNOLOGY
SHOULD ACCOMMODATE PEDIATRIC
POPULATIONS, DEVELOPED FOR HIV
AND OTHER APPLICATIONS, AND THIS
TIME WILL REQUIRE MINIMUM DOSING
INTERVAL OF 8 WEEKS, AND FURTHER
SHOULD DELIVER COMPLETE AND
CLINICALLY RELEVANT REGIMEN WITH
SINGLE PLATFORM, EXPOSURE
MATCHING WITH ADULT EXPOSURE
WITH EFFICACY FOR EACH ARV
TREATMENT.
WE'LL ALLOW SINGLE ARV WITHIN A
PLATFORM BUT DO WANT COMPLETE
PLATFORM DELIVERED REGIMEN
PROPOSED, SHOULD MAKE EFFICIENT
USE OF ANIMAL MODELS AND SHOULD
SUPPORT PK/PD STUDIES, AND WE'RE
REQUIRED ANTI-VIRAL STUDY OF
SAFETY AND EFFICACY OF THE LADDS
CANDIDATE IN NHP.
NEXT SLIDE PLEASE.
AND ADDITIONAL KEY REQUIREMENTS
WOULD BE ITERATIVE
SOCIOBEHAVIORAL STUDIES, PERFORM
WORK, PERFORMED
[AUDIO DISTORTION]
AND THOSE GROUPS WHO WILL BE
USED FOR PURPOSE OF ASSESSING
END USER PREFERENCE AND PANEL OF
DESIGN, WILL REQUIRE INDUSTRY
AND DRUG DEVELOPMENT PARTNER
WITH SIGNIFICANT (INDISCERNIBLE)
AND APPLICANT WILL NEED TO PLAN
AND CONDUCT WITH PRE-IND.
WE HAVE LISTED NONRESPONSIVE
AREAS OF RESEARCH BELOW.
SUFFICE IT TO SAY THAT A KEY
AREA WE WOULD NOT -- THERE WOULD
BE THE ENGINEERING, WOULD NOT BE
[AUDIO DISTORTION]
, NEW MOLECULAR ENTITY, ALONG
WITH CLINICAL TRIALS.
THE OTHERS ARE LISTED HERE AS
WELL.
NEXT SLIDE PLEASE.
THIS WILL USE PHASED INNOVATION
AWARDS, R61/R33 MECHANISMS, USED
TO SUPPORT HIGH RISK RESEARCH
AND DEVELOPMENT OF PROMISING AND
VIABLE CANDIDATE PRODUCTS OR
STRATEGIES.
PHASED GRANT AWARD MECHANISMS
USED FOR EARLY STAGE RESEARCH
AND DISCOVERY, PRE-CLINICAL
DEVELOPMENT OF CANDIDATE
PRODUCTS AND EXPLORATORY
PROJECTS.
AND THESE ARE SINGLE
APPLICATIONS, DISCOVERY PHASE
R61 AND IMPLEMENTATION PHASE R33
PHASES.
TRANSITION TO R33 PHASE
CONTINGENT ON SATISFACTORY R61
PILE STONE AND SUBJECT TO
FUNDING AVAILABILITY.
AND THIS AWARD WILL USE PHASED
RESEARCH ACTIVITIES, BOTH PHASES
WILL NEED TO PROPOSE MILESTONES
PROGRAM APPROVED, AND R61 PHASE
WILL FUND ACTIVITIES TO OPTIMIZE
LONG ACTING, TWO YEARS,
MILESTONES WOULD NEED TO BE
FORMULATED ACCORDINGLY, WHILE
THE R33 PHASE WILL FUND
PRE-CLINICAL ACTIVITIES SUCH AS
EXPANDED STUDIES, NHP ANTI-VIRAL
SAFETY AND EFFICACY, OPTIMIZED
LADDS FORMULATIONS AS WELL AS
PUTTING TOGETHER PRE-IND PACKAGE
AND CONDUCTING THAT PRE-IND
MEETING.
NEXT SLIDE PLEASE.
WHY IS THE ISSUE NEEDED?
WELL, LADDS II IS BUILDING ON
CONTINUING RESEARCH FROM LADDS
I, SEPARATE PROJECTS, ALL THREE
SUCCESSFULLY TRANSITIONED TO R33
PHASE, PRESENTED DIFFERENT LONG
ACTING PLATFORMS SUCH AS
MICROARRAY PATCH, AND THOSE
APPLICANTS TO MOVE TO MILESTONES
AND CONTINUING THAT RESEARCH, SO
WE THINK IT WAS A SUCCESSFUL
LADDS I, POISED TO BE A
SUCCESSFUL PROJECT.
LADDS II EXPANDS UPON THIS LADDS
I, ADDS REQUIREMENTS BELOW,
WHICH I ALREADY MENTIONED SUCH
AS MINIMUM DOSING INTERVAL TO
EXTEND TO 8 WEEKS, THE SCOPE OF
THE SOCIAL BEHAVIORAL SCIENCE
AND END USER ASSESSMENT RESEARCH
HAS BEEN SIGNIFICANTLY EXPENDED,
AND INTRODUCES NEW PRE-IND
MEETING WITH FDA REQUIREMENT
WHICH I JUST MENTIONED.
NEXT SLIDE PLEASE.
AND THERE ARE OTHER PROGRAMS,
SOME INCLUDE ACTIVITIES IN
PEDIATRIC POPULATIONS, BUT LADDS
II IS DIFFERENT, PARTICULARLY
THE RAPPS, NOSI, NONE OF THEM
SUPPORT THIS COORDINATED
LONGITUDINAL PROGRAM TO MOVE,
YOU KNOW, TO MOVE AT STAGE OF
DISEASE DEVELOPMENT TO
POTENTIALLY TRANSMISSION OF
SUPPORTING TRANSMISSION OF
RESEARCH AND ACTIVITIES MOVING
EARLIER TO CLINICAL TESTING IN
CHILDREN.
NEXT SLIDE PLEASE.
AND SO THIS WAS REVIEWED BY DR.
ABRAMS AND DR. GANDHI.
WE'RE GRATEFUL FOR INSIGHTFUL
COMMENTS, PARTICULARLY DR.
ABRAMS AND GHANDI FELT IT WAS
BORE ACTIVE TO GET LONG ACTING
FORMULATIONS TO CHILDREN.
AND AND HERE ARE SOME COMMENTS.
THEY ASKED ABOUT USE OF R61 R33
MECHANISMS, WHY IT'S NEEDED, AND
BETTER THAN OTHER MECHANISMS.
AGAIN I MENTIONED EARLIER THIS
IS MILESTONE-DRIVEN MECHANISM,
BIPHASIC NATURE IS CONTINGENT ON
MILESTONES.
WE SHOULD SAY ALSO CONTINGENT ON
DEMONSTRATING (INDISCERNIBLE)
MILESTONES, THE HIGH RISK NATURE
OF THE SOLICITED PROJECTS,
FURTHER CLARIFY IN THE
PRESENTATION, AND FULLY DESCRIBE
IN THE NOFO.
IF HE ASKED TO CLARIFY MAIN
FOCUS, IT IS ON DELIVERY SYSTEM,
WHICH HOPEFULLY WE DID, SO THE
FOCUS IS REALLY ON DEVELOPMENT
OF THE SYSTEM.
AND WE EXPECT PAYLOAD WILL BE
CLINICAL RELEVANT, AND WE
FURTHER CLARIFY IN THE NOFO.
CLARIFY MODE OF ADMINISTRATION,
WHETHER PATCH, IMPLANT, INEXTRA
MUSCULAR.
AND MINIMIZE PAIN.
WE DO NOT PARTICULAR TATE A
SPECIFIC PLATFORM BUT DO REQUIRE
CHOSEN PLATFORM BE APPROPRIATE
TO TARGET POPULATIONS SELECTED.
AND FURTHER THE EXPANDED
REQUIREMENTS FOR SOCIOBEHAVIORAL
STUDIES AS WE MENTIONED, AND THE
FACT THAT IT MUST INFORM THE END
USER OF FINAL -- END USER -- THE
FINAL PRODUCT, AND WE HOPE THIS
WILL ENSURE WHAT WE THINK IS A
PROJECT FOR FINAL SYSTEM FOR
CHILDRENS.
NEXT SLIDE PLEASE.
AND REVIEWERS ASKED US TO
CLARIFY WHO IS TARGETED, IS IT
ACADEMIA, VERSUS INDUSTRY.
WHAT WE THINK, SO WE CLARIFY
THIS IS EXPECTED TO SUPPORT
MULTI-DISCIPLINARY GROUPS, THEY
COULD BE ACADEMIA OR INDUSTRY
LED, BUT THEY SHOULD HAVE
COMPLEMENTARY EXPERTISE TO
SUCCESSFULLY IMPLEMENT THESE
PROJECTS.
AND IN PARTICULAR WE WANT TO
ENSURE THERE IS SUBSTANTIAL
INDUSTRY PARTNERSHIP AND
INDUSTRY DRUG DEVELOPER AND HOPE
WILL BRING CONTRIBUTION TO
ENSURE THERE IS POTENTIAL
MARKET.
AND FINALLY SUGGESTED
COMMUNICATION SHOULD BE
ENCOURAGED WITHIN ENTITIES IN
THE NOFO AND PLANS SHOULD BE
INCLUDED FOR FUTURE LINKING TO
OTHER DAIDS-FUNDED PEDIATRIC
EFFORTS SUCH AS IMPAACT, AND WE
AGREE, SHOULD BE SHARED IN THIS
INITIATIVE WITH GROUPS SUCH AS
IMPAACT AND THINK THAT WOULD BE
IMPORTANT TO INCLUDE CLINICAL
TRANSLATION POTENTIAL TO
CHILDREN AND THAT WOULD BE A
PROGRAM PRIORITY.
NEXT SLIDE PLEASE.
AND SO INITIATIVE SUMMARY SLIDE.
THAT'S THE END OF MY
PRESENTATIONS.
AND I CAN TAKE ANY QUESTIONS,
AND THANK YOU.
[AUDIO DISTORTION]
>> THERE WE GO.
REALLY INTERESTING PROPOSAL,
REALLY GREAT TO SEE THIS.
IT STRIKES ME THIS IS A CONCEPT
IN WHICH COMMUNITY FEEDBACK, THE
PEOPLE WHO ARE GOING TO BE
GETTING THIS, THEIR FEEDBACK IS
REALLY IMPORTANT, SO I REALLY
APPRECIATE THE BEHAVIORAL
SCIENCE USER ACCEPTABILITIES,
BUT I'M WORRIED THAT MAY COME IN
LATE IN THE PROCESS WHEN CERTAIN
REALLY IMPORTANT DECISIONS HAVE
BEEN MADE.
SO CAN YOU MAYBE JUST FILL US IN
ON WHAT YOU'RE DOING TO
ENCOURAGE THAT TO HAPPEN UP
FRONT SO POTENTIALLY MODIFIABLE
THINGS ARE ACTUALLY DONE BEFORE
THEY ARE LOCKED DOWN AND THE
STUDY GETS TOO FAR TO CHANGE
ANYTHING.
>> IT IS A GREAT POINT.
THEY SHOULD BE INITIATED EARLY
IN THE R61 PHASE.
SO VERY EARLY.
THERE WILL BE PART OF THE
MILESTONES TO INCLUDE USER
INFORMED ACTIVITIES, INFORMING
PANEL DESIGN.
WE MAY NOT BE VERY DIRECTED IN
TELLING EXACTLY WHAT THEY NEED
TO DO BUT WANT TO ESTABLISH WHAT
ARE THE ESSENTIAL PREMISES.
AND WE CERTAINLY -- WE HOPE THAT
WE HAVE USED CLEAR LANGUAGE IN
THE NOFO THAT REALLY HIGHLIGHTS
AND EXPANDS ON HOW THOSE
ACTIVITIES NEEDS TO BE NOT ONLY
START EARLY, BE ITERATIVE
THROUGHOUT THE PRODUCT
DEVELOPMENT, ON EACH PHASE, AND
WITH THE KEY PURPOSE OF EARNING
AS THEY ACCOMPLISH, THEY CAN GET
FEEDBACK TO THE DEVELOPMENT
WHICH CAN IN TERN BE SORT OF
MODIFIED AND ADJUSTED TO ENSURE
THAT IT MEETS THE END USER
CHARACTERISTICS WHICH HAVE BEEN
COLLECTED.
AND SO WHILE WE MAY NOT BE VERY
DIRECTLY HOW THIS IS GOING TO
DONE WE HOPE WE SENT A CLEAR
MESSAGE IN TERMS OF WHAT OUR
EXPECTATION IS, AND THAT
HOPEFULLY THAT'S WHAT WILL BE
DELIVERED TO US.
>> JUST AS A FOLLOW-UP, I MIGHT
ENCOURAGE YOU TO JUST CONSIDER
BEING A LITTLE BIT PRESCRIPTIVE
IN THIS CASE, AT LEAST GETTING
FEEDBACK FROM COMMUNITY FOLKS
HERE.
I REALLY THINK THAT STUFF DOES
NEED TO HAPPEN IN THE R61 PHASE
AND HOPEFULLY THAT'S NOT
OPTIONAL BECAUSE I THINK IT'S
PRETTY LATE IN THE R33 PHASE.
>> THAT SOUNDS GOOD.
SO WE WILL GO BACK AND LOOK AT
THIS AND SEE IF WE CAN IMPROVE
WITH THAT IN MIND.
>> ARE THERE QUESTIONS?
NOTHING ONLINE?
THANKS SO MUCH, PATRICK.
WE'LL MOVE ON NOW, TWO
PRESENTATIONS FROM THE VACCINE
RESEARCH GROUP, STARTING WITH
AMY PALIN WHO IS LIVE HERE.
>> LOVELY TO SPEAK TO A ROOMFUL
OF PEOPLE AND NOT MY COMPUTER
SCREEN.
I'M AMY PALIN, PROGRAM OFFICER
IN THE VACCINE PROGRAM.
AND TODAY I'M PRESENTING AN
INITIATIVE, ENGINEERING DURABLE
HIV VACCINE RESPONSES, ENDURE.
THE OBJECTIVE IS TO DEVELOP HIV
VACCINE TECHNOLOGY WITH
POTENTIAL TO CONFER DURABLE
IMMUNE RESPONSES THROUGH
HYPOTHESIS-GUIDED BASIC AND
APPLIED RESEARCH.
THIS IS A NEW INITIATIVE, R01,
FIRST YEAR TOTAL COST OF $3
MILLION.
IN JULY 2022 WE ORGANIZED A
WORKSHOP ON VACCINE DURABILITY.
AND HERE I'M HIGHLIGHTING
FACTORS ASSOCIATED WITH
SHORT-LIVED OR LONG LIVED
PROTECTION, ON THE LEFT
ILLUSTRATED BY SOFT PADS, AND ON
THE RIGHT WE HAVE FACTORS
ASSOCIATED WITH LONG-LIVED
PROTECTION, ILLUSTRATED BY THE
SUIT OF ARMOR, THESE ARE THINGS
LIKE ANTIGEN VALENCE AND
UNKNOWNS.
THIS WORKSHOP AND FOCUS ON
DURABILITY OCCURRED IN THE
CONTEXT OF THE SARS-COV-2
PANDEMIC, AND I WANT TO USE THE
DATA FROM THE U.S. ON VACCINE
UPTAKE TO ILLUSTRATE THE VALUE
OF DURABLE RESPONSES.
ON THE LEFT WE HAVE PERCENTAGE
OF THE ADULT U.S. POPULATION
THAT COMPLETED PRIMARY SERIES,
IT'S RIGHT AROUND 70%.
WHEREAS ONLY 20% ACTUALLY UNDER
20% OF THE POPULATION RECEIVED
BIVALENT BOOSTER DOSE.
THIS DISCREPANCY REALLY
HIGHLIGHTS THE IMPORTANCE OF
ACHIEVING DURABLE PROTECTION TO
PREVENT INFECTIONS.
AT THE SAME TIME, AROUND THE
SAME TIME, YOU'VE HEARD SOME OF
THIS THIS MORNING, SIGNIFICANT
CLINICAL VACCINE ADVANCES, ON
THE LEFT FROM THE AMP TRIALS,
ESTABLISHED THAT PATH OF
ADMINISTRATION OF BROADLY
NEUTRALIZING ANTIBODY COULD
PREVENT ACQUISITION OF STRAINS
OF HIV THAT WERE SENSITIVE TO
NEUTRALIZATION BY THE ANTIBODIES
VRC-01 UNDER A CERTAIN
CONCENTRATION OF ANTIBODY, IN
THE TOP LINE YOU CAN SEE
PREVENTION EFFICACY AGAINST
SUSCEPTIBLE STRAINS.
IN ANOTHER TRIAL, THIS WAS A
PHASE 3 EFFICACY TRIAL, IN A
PHASE 1 TRIAL THEY DEMONSTRATED
THE ABILITY TO INDUCE VRC-01
CLASS B PRECURSORS, RECOGNIZING
THE BINDING SITE AND IMMUNOGEN
HERE eOD-GT8 IS ENGINEERED.
YOU CAN SEE THE NUMBER OF CLASS
B CELLS ON THE TOP ROW, BOTTOM
PERCENTAGE.
THESE EXPANDED SIGNIFICANTLY
AFTER IMMUNIZATION, AND THE TWO
COLORS ARE TWO DOSES OF VACCINE.
WHAT I ALSO WANT TO HIGHLIGHT
HERE IS THAT THEY SAW EXPANSION
OF CLASS B CELLS IN LYMPH NODE
GERMINAL CENTERS.
WE HAVE PROOF OF PRINCIPLE FOR
PROTECTIVE MECHANISM AGAINST
HIV, WITH BROADLY NEUTRALIZING
ANTIBODY ADMINISTRATION, AND
PROOF WE CAN INITIATE AND
EXPAND bNAb ANTIBODY
LINEAGES IN PEOPLE THROUGH
VACCINATION.
SO WITH THESE SUCCESSES, WE
THINK IT'S IMPORTANT TO FOCUS ON
THE DURABILITY OF VACCINE
PROTECTION AND VACCINE
RESPONSES.
A SUCCESSFUL HIV VACCINE MUST
ACHIEVE BROAD DURABLE AND
DEPENDING ON THE APPROACH OF
MECHANISM POTENTIALLY
STERILIZING IMMUNITY.
THIS WILL REQUIRE UNDERSTANDING
AND ENGINEERING DURABLE HIV
VACCINE TECHNOLOGY.
PARTICULARLY WITH INCREASING USE
OF mRNA PLATFORMS.
AS WE'VE SEEN FROM SARS-COV-2,
mRNA VACCINATION DOES NOT
ALWAYS RESULT IN LONG LIVED
SERUM ANTIBODY RESPONSES.
IT FOLLOWS INCREASING DURABILITY
OF A PROTECTIVE HIV VACCINE WILL
FURTHER REDUCE INCIDENCE OF HIV.
THE ENDURE INITIATIVE WILL
FOCUS -- WILL SUPPORT
HYPOTHESIS-DRIVEN BASIC RESEARCH
AND ITS APPLICATION TO
DEVELOPMENT OF HIV VACCINE
TECHNOLOGY, THAT CAN INDUCE
DURABLE IMMUNE RESPONSES.
THERE ARE A NUMBER OF GAPS IN
THE RESEARCH AND OPPORTUNITIES
TO ADDRESS THESE GAPS AND
ADVANCE THE FIELD.
FIRST OF THIEVES IS IN DEFINING
DURABLE VACCINE RESPONSES, SO
HOW DO WE DEFINE PROTECTION,
WHAT ARE SOME OF THE IMMUNE
MECHANISMS OF DURABLE RESPONSES,
NEXT GAP IS IN MEASURING DURABLE
RESPONSES, WITH FEW EXCEPTIONS
WE DON'T HAVE A GOOD HANDLE ON
MARKERS, CELL TYPES, OR TISSUES
TO ASSAY, OF COURSE WE TYPICALLY
LOOK IN THE BLOOD AND PBMCs
BUT AS YOU KNOW HIV EXPOSURE AND
INFECTION OCCUR IN THE RECTAL
AND VAGINAL MUCOSA.
THE LAST GAP IS IN ENGINEERING
DURABLE VACCINE RESPONSES.
UNDERSTANDING WHICH PROPERTIES
OF THE VACCINE SUCH AS PLATFORMS
AND EXAMPLES I'LL SHOW IN THE
NEXT SLIDE REALLY INDUCE MORE
DURABLE RESPONSES.
AND CRITICALLY WHAT ARE SOME OF
THE OPTIMAL EARLY AND NATURE
IMMUNE RESPONSES THAT CAN
PROGRAM LATER DURABILITY, THIS
IS PARTICULARLY IMPORTANT
BECAUSE UNDERSTANDING SOME OF
THESE FACTORS AND GETTING AN
EARLIER READ ON DURABILITY CAN
ALLOW RESEARCHERS AND DEVELOPERS
TO SIGNIFICANTLY ADVANCE VACCINE
DEVELOPMENT.
THIS IS DATA WHERE THEY HAVE A
LONGITUDINAL COHORT, AND THEY
HAVE MEASURED ANTIBODY TITERS TO
A NUMBER OF PATHOGENS THAT
PEOPLE IN THE U.S. ARE COMMONLY
VACCINATED FOR, DEMONSTRATING
THE VACCINE PLATFORM CAN AFFECT
THE DURABILITY OF PROTECTIVE
TITERS.
SO ON THE LEFT WE HAVE -- THEY
MEASURED TITERS AND CALCULATED
WHEN INDIVIDUAL'S TITER WOULD
DROP.
ON THE LEFT DIPHTHERIA AND
TETANUS, YOU CAN SEE A STEEP
DECLINE IN PROTECTION IN
ANTIBODY PROTECTION, AND THESE
ARE MONOVALENT PROTEIN VACCINES.
ON THE RIGHT IN GREEN AND BLUE
WE HAVE MEASLES AND RUBELLA WITH
LOWER RATES OF DECAY.
THESE ARE MULTIVALENT
REPLICATING VIRUSES.
VIRAL VACCINES OF THE THE FORMAT
OF THE VACCINE CAN REALLY IMPACT
THE DURABILITY OF THE ANTIBODY
RESPONSE AND PROTECTIVE ANTIBODY
RESPONSE.
HERE IS AN EXAMPLE FROM HIV, AND
THIS IMMUNOGEN EOD-GTIS RELATED
TO THE ONE I SHOWED EARLIER,
TARGETS VRC-01 CELLS AND
RECOGNIZES THE BINDING SITE ON
THE ENVELOPE.
THIS IS MOUSE DATA
WHAT THEY DID HERE WAS
RESEARCHERS PERFORMED ADOPTIVE
TRANSFER OF B CELLS EXPRESSING
THE VRC-01 PRECURSOR HEAVY AND
LIGHT CHAINS, AND POLYCLONAL B
CELLS TO ESTABLISH MORE
PHYSIOLOGICALLY RELEVANT
PRECURSOR FREQUENCY.
THESE MICE WERE THEN IMMUNIZED
WITH EODGT 2 AS A FORMER OR FOUR
COPIES OR 60 COPIES.
ON THE BOTTOM ARE DATA, YOU CAN
SEE A STRIKING DIFFERENCE
BETWEEN FORMER IN DARK BLUE AND
THE PURPLE MAGENTA COLOR WITH
60MER, EXPANSION OF THESE
TRANSGENIC B CELLS EXPRESSED IN
THE VRC-01 PRECURSOR, YOU CAN
SEE PERCENTAGE ON THE LEFT AND
IN THE MIDDLE THE NUMBER OF B
CELLS, IN THE GERMINAL CENTERS,
DIFFERENCE IN ENGAGEMENT AND
EXPANSION, LONGER TERM
MAINTENANCE IS STRIKING.
ANOTHER EXAMPLE OF VACCINE
PARAMETERS THAT CAN BE
MANIPULATED TO AFFECT THE
DURABILITY OF THE IMMUNE
RESPONSE.
THIS INITIATIVE HAS A FEW AREAS
OF INTEREST THAT CORRESPOND TO
GAPS I OUTLINED BEFORE.
THE FIRST IS IN DEFINING DURABLE
IMMUNITY.
SO THIS INCLUDES IDENTIFICATION
OF BIOMARKERS, SIGNATURES,
PREDICTORS OF DURABLE IMMUNE
RESPONSES, IDENTIFICATION AND
STUDY OF EARLY IMMUNE RESPONSES
THAT CAN PROGRAM LATER DURABLE
IMMUNITY, AND COMPARISONS OF
VACCINE PARAMETERS LIKE THOSE I
SHOWED YOU.
THE SECOND GAP IS IN MEASURING
DURABLE IMMUNITY, SO THIS
INCLUDES DEVELOPMENT OF ASSAYS
AND TECHNIQUES, INCLUDING
MUCOSAL SAMPLING SINCE WE KNOW
HOW IMPORTANT MUCOSAL IMMUNITY
IS FOR PREVENTION, AND STUDY AND
APPLICATION OF BIOMARKERS.
LAST GAP IN ENGINEERING DURABLE
IMMUNITY WILL INCLUDE THINGS
LIKE OPTIMIZATION OF VACCINE
PARAMETERS, LIKE ANTIGEN
VALUENTS, DISPLAY, PLATFORM,
OTHER PARAMETERS, STRATEGIES TO
INDUCE GERMINAL CENTERS AND
OPTIMIZATION OF EARLY IMMUNE
ACTIVATION PATHWAYS.
THIS SUPPORTS RESEARCH WITH
HUMAN, ANIMAL SAMPLES, CLINICAL
TRIALS NOT ALLOWED.
THE ENDURING INITIATIVE
COMPLEMENTS OTHER NIAID
PROGRAMS, FIRST IS THE DIVISION
OF AIDS ENGINEERING IMMUNITY TO
HIV THROUGH NEXT GENERATION
VACCINES, THIS HAS FOUR AWARDS,
AND NONE FOCUS ON VACCINE
DURABILITY.
DIVISION OF ALLERGY IMMUNOLOGY
AND TRANSPLANTATION RECENTLY
ISSUED MAINTAINING IMMUNITY
AFTER IMMUNIZATION AND THESE ARE
REALLY NICE MECHANISTIC STUDIES
OF HOW IMMUNITY AND IMMUNE
RESPONSES ARE MAINTAINED AFTER
VACCINATION.
BUT IT EXCLUDES HIV.
AND YOU WILL HEAR NEXT FROM
ANGELA ABOUT STRATEGIES FOR
CONTROLLED RELEASE OF HIV
VACCINE.
SO WHY DO WE NEED AN HIV CONCEPT
FOR THIS?
AS YOU'RE ALL PROBABLY MORE
AWARE, THERE'S AN EXTREMELY
NARROW WINDOW AFTER EXPOSURE TO
HIV, TO PREVENT ESTABLISHMENT OF
RESERVOIR, LIFELONG INFECTION,
ASSOCIATED SEQUELAE.
TREMENDOUS DIVERSITY OF HIV
STRAINS IS A PARTICULARLY
DIFFICULT OBSTACLE FOR VACCINE
DEVELOPMENT.
THERE'S NEED FOR PROTECTION IN
MUCOSAL TISSUE, HIV HAS COMPLEX
INTERACTIONS WITH THE HUMAN
IMMUNE SYSTEM, ABLATING CD4
COMPARTMENT WHEN HIV IS NOT
CONTROLLED, INCLUESING
INFLAMMATORY STATES.
FINALLY SOPHISTICATION OF HIV
VACCINE APPROACHES.
YOU HEARD THIS MORNING HOW WORK
ON HIV STRUCTURE OF THE
ENVELOPE, TRANSLATED IN PART TO
SUCCESS OF THE RSV VACCINE, SO
WE'VE HAD TO ADOPT SOME REALLY
THINK COMPLEX AND INTRICATE
APPROACHES TO SUCCESSFUL HIV
VACCINATION.
I WOULD LIKE TO THANK DOCTORS
GOEPFERT AND JEROME FOR
REVIEWING, PROVIDING FEEDBACK
THAT STRENGTHENED THE
INITIATIVE.
THEY SAID THIS IS AN IMPORTANT
AND TIMELY TOPIC, GIVEN THE
ADVANCES IN mRNA TECHNOLOGY
AND OTHER APPROACHES FOR HIV
IT'S CLEAR THAT DURABLE IMMUNITY
WILL BE CRITICAL TO ENDING THE
HIV PANDEMIC.
THE INITIATIVE ORIGINALLY READ
VACCINE PROTECTION AND THEY
ASKED US TO EXPAND THAT TO
VACCINE RESPONSES, IN PART
BECAUSE OF THE LACK OF DATA FOR
PROTECTION.
AND ALSO TO EXPAND THE SCOPE AND
LEARN FROM RESPONSES THAT MAY
NOT BE PROTECTIVE BUT THAT ARE
LONG LIVED.
THEY ALSO SAID WHILE
NEUTRALIZING ANTIBODIES HAVE A
CRITICAL ROLE THERE MAY BE OTHER
PROTECTIVE RESPONSES.
A MORE INCLUSIVE CONCEPT MAY
INVITE MORE NEW AND INNOVATIVE
APPROACHES.
WE COMPLETELY AGREE AND THE
FUNDING ANNOUNCEMENT WILL
CLARIFY THAT OTHER RESPONSES ARE
RESPONSIVE.
WE INCLUDED bNAbs TO
HIGHLIGHT PROGRESS IN VACCINE
DEVELOPMENT.
THERE WAS A POINT ABOUT
CORRELATING ENDPOINTS TO
BIOMARKERS AND SIGNATURES, AND
THE REVIEWERS HIGHLIGHTED IT WAS
PROBABLY NOT PARTICULARLY
RELEVANT FOR HIV SOY WE REMOVED
THAT AREA OF INTEREST.
AND FINALLY THEY ASKED US TO
EXPAND ON THE NEED FOR AN
HIV-SPECIFIC CONCEPT.
SO WE EXPANDED THAT RATIONALE
HERE.
SO I WILL CONCLUDE AND I'M HAPPY
TO TAKE QUESTIONS.
>> LOOKING AROUND THE ROOM, I
DON'T SEE -- ARE THERE ANY
QUESTIONS?
OKAY.
YES?
>> LOUIS SHACKLEFORD, HIV
VACCINE TRIALS NETWORK.
I WAS CURIOUS, SO UNDERSTANDING
THAT THIS IS KIND OF BENCH
SCIENCE, BUT ALSO FROM MY
PERSPECTIVE AND MY WORK IN
EXTERNAL RELATIONS SEEING THE
NEED FOR COMMUNITIES TO
UNDERSTAND WHEN IT COMES TO
VACCINES AND UNDERSTANDING THAT
FOLKS ARE A LITTLE BIT CONFUSED
AT HOW WE GOT A COVID-19 VACCINE
SO QUICKLY AND WE'RE STILL
WORKING ON AN HIV VACCINE.
AND SO I WOULD JUST -- MY
QUESTION TO YOU IS HAS ANY
THOUGHT BEEN GIVEN TO
COMMUNICATING THIS SCIENCE TO
COMMUNITIES, AND IF SO JUST
ENCOURAGING YOU TO TO THINK
ABOUT HOW TO COMMUNICATE THESE
THINGS TO COMMUNITIES BECAUSE
THERE IS A NEED AND WE SEE WHAT
HAPPENED WITH COVID-19 WHEN I
THINK WE GOT A VACCINE REALLY,
REALLY QUICKLY AND FOLKS WEREN'T
PREPARED TO UNDERSTAND THE
SCIENCE WHY THAT HAPPENED SO
QUICKLY.
AND SO THAT'S ALWAYS ON THE
FOREFRONT OF MY MIND NOW WHEN IT
COMES TO HIV VACCINES.
>> YEAH, ABSOLUTELY.
WE NEED TO DO A BETTER JOB
COMMUNICATING THE SCIENCE, I
COMPLETELY AGREE WITH YOU.
AND COMMUNICATING THAT COVID AND
HIV ARE REALLY, AS THEY SAY, TWO
DIFFERENT BEASTS.
BUT I HAVE TO SAY I AM NOT UP ON
STRATEGIES FOR COMMUNICATING,
AND I WOULD LIKE TO DO A BETTER
JOB OF THAT.
I ACTUALLY THINK THE HCVN DOES A
FANTASTIC JOB AND WE NEED TO DO
MORE OF THAT.
>> OTHER COMMENTS?
ANYTHING ONLINE?
NOPE, OKAY.
WELL, THANK YOU VERY MUCH.
AND EVERYBODY, PLEASE GO BACK TO
YOUR BALLOTS AND VOTE.
YOU MAY HAVE BEEN TIMED OUT, IF
YOU'VE BEEN ON FROM THE VERY
BEGINNING SO YOU HAVE TO REFRESH
OR GO BACK TO THE SITE AGAIN.
OKAY.
NOW WE'RE DOING THAT.
LET ME INTRODUCE THE NEXT
SPEAKER, ANGELA MALASPINA.
>> OKAY.
THANK YOU FOR THE OPPORTUNITY TO
TALK ABOUT THIS NEW CONCEPT,
STRATEGIES FOR CONTROLLED
RELEASE OF HIV VACCINE, I'M IN
THE VACCINE PROGRAM, TODAY MY
COLLEAGUES.
THE OBJECTIVE ADVANCE STRATEGIES
FOR CONTROLLED VACCINE RELEASE
TO IMPROVE IMMUNE RESPONSE TO
HIV PREVENTION, TREATMENT, CURE,
DEVELOP SIMPLIFIED SINGLE-SHOT
VACCINATION STRATEGY JUST,
BIPHASIC CODE WITH NO CLINICAL
TRIALS ALLOWED, FIVE YEARS, TWO
PHASES, R61 AFTER THREE YEARS,
R33 AFTER TWO YEARS, $750,000
PER YEAR.
AND CAN BE SPREAD ACROSS LIKE A
COUPLE STUDIES, AND THIS IS
TOTAL COST IN THE FIRST YEAR OF
THE R33, I'LL EXPLAIN THE
DELIVERY OF ANTI-VIRAL, WE CAN
DISCUSS ABOUT IT.
KEY FEATURES OF THE PROGRAM,
TWO-PHASE MILESTONE-DRIVEN
MECHANISM, MILESTONES
INCORPORATED INTO THE TERMS OF
THE AWARD, R61 PHASE TO OPTIMIZE
DELIVERY PLATFORMS FOR CONTROL
TEMPORAL AND SPATIAL RELEASE AND
IF THEY REACH THE MILESTONE MOVE
TO R33 PHASE, CLINICAL WORK OR
PRODUCT DEVELOPMENT, DEPENDS HOW
ADVANCED THEY ARE, AND BECAUSE
REALLY FACILITATE TRANSLATION.
THIS REASON WE REQUIRE
TRANSLATIONAL PARTNERSHIPS AMONG
ACADEMIA, INDUSTRY, AND/OR
GOVERNMENT.
AS I TOLD YOU WE WANT TO
BEHAVIORAL COMPONENT TO STUDY
END USER PREACH -- END USER
PREFERENCE FOR CONDENSED
IMMUNIZATION REGIMENS,
ENCOURAGED FOR R33 BUT NOT
REQUIRED.
STUDY DESIGN TRANSLATE INTO
PRODUCT TO HAVE SOLID UPTAKE AND
USE.
BACKGROUND, WE KNOW NATURAL
INFECTIONS EXPOSE THE BODY TO
INFLAMMATION AND ANTIGENS OVER
DAYS TO WEEKS, RESULTING IN
POTENT AND LONG-LASTING
PROTECTIVE IMMUNITY.
MOST CONVENTIONAL SUBUNIT
VACCINES DELIVERED IN BOLUS,
EXPOSE TO ANTIGENS HOURS OR
DAYS, AND OFTEN NECESSITATE
BOOSTER SHOTS TO INCREASE
EFFICACY.
FOR EXAMPLE WE THINK ABOUT THE
WAY WE WANT TO GENERATE BROADLY
NEUTRALIZING ANTIBODIES, WILL
LIKELY REQUIRE REPEATED
ADMINISTRATION OVER LONG
PERIODS, SHOWN HERE, PRIME AND
SEVERAL BOOSTS FOR bNAb
ACTIVITY.
WE BELIEVE IT'S IMPORTANT TO
HARNESS CONTROLLED RELEASE
PLATFORM THAT MIMIC INFECTION,
GENERATE bNAb RESPONSES, AND
DESIRABLE IMMUNE RESPONSES.
IMPACT ON T CELL APPROACHES AND
GENERATION OF CD8 T CELLS WILL
BE IMPORTANT, SO WE RECOGNIZE
HIV VACCINE ANTIGEN AND ADJUVANT
STILL REQUIRES OPTIMIZATION AND
SELECTION.
WE THINK ADVANCING SAFE
EFFECTIVE SOLUTIONS IS STILL AN
UNMET NEED THAT MAY IMPROVE
VACCINE EFFECTIVENESS AND
PRACTICALITY, FOR EXAMPLE
SINGLE-SHOT FORMULATION, BETTER
ADHERENCE, FEWER ADVERSE
REACTION, COST SAVINGS.
RECENT SCIENTIFIC ADVANCES,
MATERIALS BASED SCIENCE, NEW
RELEASE TECHNOLOGIES, DELIVERY
SYSTEMS, IMMUNOLOGY, TO TARGETED
RELEASE OF VACCINE COMPONENTS.
AND AGAIN AS I TOLD YOU VACCINE
COMPONENT MUST BE IN THE RIGHT
LOCATION AT THE RIGHT TIME TO
ORCHESTRATE RESPONSES, SPECIFIC
PRODUCTS, THINKING ABOUT
PRODUCTS LIKE HYDROGELS, HE
MICRONEEDLES, NANOPARTICLES IN
TIME FOR CONTROLLED INTERACTION
WITH IMMUNE CELLS.
YOU HEARD ABOUT THE SAME
PLATFORM FOR DELIVERY OF
ANTI-VIRAL, PROBABLY ALSO
MONOCLONAL ANTIBODIES, AND GOOD
THING, THEY CAN DELIVER VACCINE
CARGO OVER MONTHS, REGULATE
INNATE IMMUNE CELL ACTIVATION,
AND HYDROGEL INFECTION CAN
GENERATE VACCINE UPTAKE AND
IMPROVING ANTIGEN PRESENTATION,
TARGET LYMPH NODES, MUCOSA,
RELEVANT TISSUES.
ALSO CAN PRESERVE IMMUNOGEN
STRUCTURE, ENABLE ROOM STORAGE
TEMPERATURE.
WE THINK ABOUT CONTROLLED
RELEASE KINETICS WE THINK
KINETICS OF ANTI-JOHN/ADJUVANT
RELEASE AND PRESENTATION TO
IMMUNE CELLS TO AFFECT EFFICACY,
TO UNDERSTAND RELATIONSHIP
BETWEEN VACCINE RELEASE KINETICS
AND OVERALL IMMUNE RESPONSES
WILL AID IN DEVELOPING OPTIMIZED
DELIVERY PLATFORM.
HERE WE SEE EXAMPLE WORK FROM
TAM IRVINE, IMPROVE ANTIBODY
RESPONSE IN MICE, COMPARE HERE
TRADITIONAL BOLUS WITH REPEATED
INJECTION, SPECIFICALLY THEY
SHOW EXPONENTIAL INCREASE,
FRACTIONATED DOSING OR DELIVERY,
IS IMPACTING RESPONSE, NEW
RESPONSES, REALLY CREATING
BETTER ANTIGEN RETENTION.
IF WE LOOK AT THE ANTIBODY
OUTPUT WE CAN SEE EXPONENTIAL
INCREASE, 13 TIMES MORE OUTPUT
OF ANTIBODIES WHEN COMPARING TO
BOLUS.
IT'S REALLY LIKE A BIG
DIFFERENCE.
AND WHEN WE THINK ABOUT
SUSTAINED RELEASE, FRAMING
VACCINE DELIVERY IN DIFFERENT
WAYS, WE THINK ABOUT SINGLE
SUSTAINED RELEASE, MORE STUDIED,
WE THINK ABOUT DELIVERY LIKE
OSMOTIC PUMPS, HYDROGEL,
MICROPARTICLE, WANT TO MIMIC
PRIME AND BOOST, WITH PULSATILE
RELEASE AND A LOT OF DATA IN
PRE-CLINICAL, LAYER BY LAYER
MICROPARTICLE, MICRONEEDLE.
SO BUT THERE'S A LOT OF
PROMISING BUT NOT MUCH EFFICACY,
OBSTACLES REMAIN, DIFFICULTY
MAINTAINING STABILITY,
BIOACTIVITY, CONTROLLING DESIRED
RELEASE KINETICS, SELECTING
BIODEGRADE AL SAFE FORMULATION,
AND ALSO EVENTUALLY
MANUFACTURING CONSTRAINT LIKE
SCALING UP.
THINKING ABOUT DELIVERY, CONCERN
ABOUT CD8 T CELLS, ENCOURAGING
RESULTS, THIS IS A LOT OF THE
WORK PUBLISHED WITH DELIVERY,
GERMINAL CENTERS, ANTIBODY
RESPONSES, THIS IS THE COMPARE
CONVENTIONAL VERSUS SLOW
DELIVERY OSMOTIC PUMPS OR
FRACTIONATED DELIVERY.
IT WAS PROLONGED ANTIGEN
EXPOSURE, ENVELOPE RETAINING
WITH THE RIGHT STRUCTURE FOR
LONGER, INCREASE SO PATTIC
HYPERMUTATION AND AFFINITY
MATURATION, GREATER ANTIBODY
DIVERSITY AND NEUTRALIZING
ANTIBODY TITERS.
IF YOU HAVE A LONG PRIMING,
AGAIN IN MONKEYS, THE SAME
DOSES, YOU DO THIS MUCH LATER
ON, THIS IS A PAPER, PROLONGED
MATURATION, YOU'LL SEE MORE
CONSISTENT AND ROBUST BROADER,
NOT BROADLY, TITER, LEADING DATA
SUPPORT THIS DELIVERY.
HERE THERE'S A LOT MORE PLATFORM
THERE, LIKE -- WE WOULD LIKE TO
EXPLORE THE STAGE, THIS IS
CALLED STAMPED ASSEMBLY POLYMER
LAYER, AND THESE ARE LIKE A
SYRINGE CONTAIN SEVERAL
MICROPARTICLE, DELAYED PULSE OF
ANTIGEN TO IMITATE CONVENTIONAL
BOLUS INFECTION, THE DELIVERY OF
DIFFERENT ANTIGEN.
IF YOU LOOK, THIS IS THE RED
LINE, WHAT YOU OBTAIN, IN PURPLE
IS REALLY CORRESPONDING TO TWO
BOLUS VACCINATION WITH DOUBLE
DOSE OF ANTIGENE REALLY
PERFORMING WELL, SIMILAR BUT
CORE SHELL MICRO NEEDLE,
MULTIPLE VACCINE PAYLOAD, FULLY
IMPLANTED INTO THE SKIN,
MULTI-BURST PROFILE.
A LOT OF WORK FROM OUR
COLLEAGUES IN DAIDS, NIMH, SINCE
2015, SUSTAINED RELEASE FOR
PREVENTION OF HIV OR TREATMENT
OF LATENT TB/HBV.
NOW MORE RESEARCH ON DEVELOPMENT
NEXT GENERATION DEVICES
MATERIALS-BASED PLATFORM MORE
ADMINISTRATION OF HIV-1
bNAbS.
AND THEN ENGINEERING DURABLE HIV
VACCINE RESPONSES, THEY HAVE
MUCH BROADER SCOPE.
WHAT ARE WE DOING IN OUR
PORTFOLIO, ESPECIALLY HIV
PREVENTION, AND IN DAIT.
EXAMPLE OF WORK IN THE SON
COURTA FOR HIV VACCINE AND
DEVELOPMENT, CONTRACT WITH DAIDS
AND DAIT, THE STAGE WE COMPARE
THE SAME CONSTRUCT, CAN BE
VACCINE, HIV ENVELOPE DELIVERED
BY BOLUS, AND NOW INCLUDE
OTHERS, HYDROGEL, WE HAVE THIS
WAY OF DELIVERY,
(INDISCERNIBLE) SLOWLY.
FREEZE DRIED FORMULATION,
DIFFERENT LAYERS IN THE RELEASE
AT DIFFERENT TIMES, HAVING MORE
OF A PULSATILE WAY TO DO IT.
WHAT ARE WE DOING IN THE
CLINICAL VACCINE PIPELINE?
WE'RE DOING IMMUNOGENICITY OF
BOLUS VERSUS FRACTIONATED
DOSING/DELIVERY.
CLINICAL TRIAL BEFORE THE END OF
THIS YEAR, BOTH ARE TRIMER OR
SCAFFOLDING, VULNERABILITY IN
HIV, AND THIS IS STUDY FOR
VRC-01, THE PRIME HAS A LOT OF
ESCALATING DOSES.
IN THE CASE, THEY WANT TO MIMIC
VIRAL REPLICATION, MORE
COMPLICATED REGIMEN.
THEY CALL IT RAPIDVAX.
AFTER THE PRIME THEY GO FASTER,
ONLY THREE, D 4, 8, 15.
IT'S NOT PRACTICAL.
WE WANTED TO WORK ON MORE
PRACTICAL WAYS.
WHAT WE'RE DOING AS WELL, SOME
STUDIES LIKE HVTN 144 IN ANIMAL
MODEL, WE HOPE WILL BE ABLE TO
ESTABLISH PREDICTIVE VALUE ON
ANIMAL MODELS, AND HUMAN TRIAL
WE WANTED TO LEVERAGE THIS
PLATFORM AND EVALUATE IN SMALL
ANIMAL MODELS, WE DON'T HAVE A
LOT OF DATA IN THIS AREA.
IT REQUIRED DEEP IMMUNOLOGIC
INVESTIGATION, ANTIGEN FOR
SUSTAINED RELEASE FOR A LONG
TIME.
WHAT ABOUT ADJUVANT?
ALSO STUDYING AGAINST CURRENT
OPTIMAL VACCINE, IF I DO PRIME
BOOST AND WITH PERFECT ADJUVANT
IS THE CONTROL OF THIS PLATFORM
BETTER OR SAME AT LEAST BUT NOT
INFERIOR, OTHERWISE WE HAVE A
PROBLEM.
ASSESSING ADVANTAGES AND EFFECTS
OF PROLONGED VACCINE DELIVERY,
LONGITUDINALLY.
IT'S IMPORTANT TO FOLLOW IT LONG
TERM.
IT IS EARLY STAGES.
THE IDEA TO HARNESS PROGRESS
TOWARDS CONTROLLED RELEASE
TECHNOLOGY TO DEVELOP SIMPLIFIED
OR SINGLE SHOT VACCINATION
STRATEGIES THAT MIMIC
MULTI-DOSE, PRIME-BOOST REGIMENS
OR INFECTION.
IF YOU CAN MIMIC VIRAL VACCINE
WITH ENGINEERING IT, WOULD BE
VERY EXCITING, FOR EXAMPLE, FOR
THE T CELL APPROACHES.
ALSO OF COURSE ADVANCE PRACTICAL
SOLUTION FOR CLINICAL USE,
AMOUNT MIZEED FOR ROUTE OF
ADMINISTRATION, NUMBER OF DOSES,
COST, SUBJECT TOLERABILITY.
WE WANT PLATFORMS OUT THERE FOR
A WHILE, IMMUNOLOGY ASPECT,
TRANSLATIONAL PARTNERSHIP.
33 PHASE, EVALUATION IN ANIMAL
MODELS, BUT EVEN MORE ADVANCED
WE WANT TO LOOK AT MAINTENANCE
THROUGHOUT DELIVERY PERIOD,
FEASIBILITY OF GMP
MANUFACTURING.
AND AS YOU HEARD FROM PATRICK,
BEGIN TO UNDERSTAND END USER,
AND USE THIS INFORMATION TO
REFINE DEVELOPMENT.
IF YOU'RE MORE ADVANCED, THE
QUESTION ABOUT IS TECHNOLOGY
AMENABLE TO COMBINATION VACCINE?
WHAT LEVEL OF INJECT
INJECTABILITY, CAN WE SCALE UP?
I WANT TO THANK OUR REVIEWERS,
TO RECOMMEND FOR APPROVAL,
TIMELY GIVEN IMMUNOLOGY AND
CRITICAL TO DEVELOPING
PROTECTION BY RESPONSES,
POTENTIALLY T-CELL RESPONSES ON
IMPROVING AND EMERGING,
RECOMMEND TO CLEARLY DELINEATING
MILESTONES, PARTICULARLY AROUND
USING APPROPRIATE SMALL ANIMAL
MODELS AND HOW TO DEFINE
RELEVANT ANTIBODY OR T
CELL/INNATE OUTCOMES AND MOVE
FORWARD BECAUSE WE DON'T HAVE
PROTECTION, WE'RE NOT SURE, WE
HAVE TO MAKE SURE THE MICE ARE
WELL SET.
SUPPORTED BEHAVIORAL RESEARCH
COMPONENT IN R33 PHASE, USING
THIS BEHAVIORAL METHOD TO
APPROPRIATE STAGE OF PRODUCT
DEVELOPMENT, SO DEPENDS HOW
ADVANCED IT IS OR IT IS NOT.
GIVEN CONCEPT IS FIRST ATTEMPT
TO LEVERAGE AND GAIN BASE
KNOWLEDGE OF VARIOUS APPROACHES,
THEY RECOMMEND NEED FOR
COMPREHENSIVE IMMUNOLOGY,
LONGITUDINALLY IN TISSUES AS
WELL AS MUCOSA, EVALUATING
ADVANTAGES AND DETRIMENTAL
EFFECTS OF DELIVERY STRATEGIES
INCLUDING EXTENDED ANTIGEN AND
ADJUVANTS TO IMMUNE CELL
EXHAUSTION OR IMMUNE TOLERANCE,
AND INCLUDING ROBUST BENCHMARK,
CURRENT OPTIMAL VACCINE, STUDY
LONGITUDINALLY IN PARALLEL TO
NEW PLATFORM, IDENTIFY DUE TO
SUSTAINED/PULSATILED AM VERSUS
BETTER ANTIGEN OR ADJUVANT.
I'M DONE.
I'M READY FOR QUESTIONS YOU MAY
HAVE.
THANK YOU.
>> YOU CAN TAKE A BREATH NOW.
>> THANK YOU.
>> YOU SPED RIGHT THROUGH IT.
DO WE HAVE A QUESTION?
>> THANK YOU.
TO FOLLOW UP ON EARLIER THEMES
AND QUESTIONS, THE BEHAVIORAL
COMPONENT, YOU INDICATED WAS
GOING TO BE OPTIONAL, IF I
UNDERSTOOD CORRECTLY, AND
OBVIOUSLY I AGREED WITH THE
REVIEWERS THAT SUPPORTS
BEHAVIORAL COMPONENT AND I WOULD
CERTAINLY SUGGEST THAT IT BE A
PART OR MANDATORY COMPONENT.
WE JUST NEED TO KNOW MORE ABOUT
THE EXPERIENCE OF THE USER IN
THESE STUDIES TO INFORM THE
FIELD GOING FORWARD IN THE NEXT
STUDY.
IF THERE'S ANY WAY TO MAKE THAT
MANDATORY OR PART OF THE STUDY
REQUIREMENTS IT WOULD BE
RECOMMENDED.
THANK YOU.
>> OKAY, THANK YOU.
>> JUST A QUICK QUESTION.
WITH-- RUBEN HARRIS, U.T.
HEALTH, SAN ANTONIO.
CONTROLS FOR THIS EXPERIMENT, IF
YOU'VE GOT A SLOW RELEASE
STRATEGY WHERE YOU'VE GOT LAYER
UPON LAYER LIKE A JAWBREAKER,
HOW DO YOU CONTROL FOR THAT?
YOU CAN'T JUST HAVE A SIMPLE
PLACEBO, RIGHT?
BECAUSE IT'S PERSISTING IN THE
SYSTEM LONGER.
SO WHAT ARE THE CONTROLS THE
GROUPS ARE PROPOSING?
>> THIS IS WHERE YOU THINK ABOUT
CLINICAL TRIAL.
I DON'T THINK WE'RE THERE YET.
SO WE'RE STILL BASIC
PRE-CLINICAL PHASES HERE SO
WE'RE NOT -- IT'S NOT ABOUT
CLINICAL TRIALS.
I HAVE TO THINK ABOUT IT, YOU
CAN DO PLACEBO, I DON'T KNOW.
YOU CAN COMPARE MAYBE TO
INJECTION AND PRIME BOOST, BUT,
YEAH.
>> MAYBE, BECAUSE IT'S NOT THE
SAME AS LIKE A SALINE OR A MOCK
OR EMPTY CONTROL.
>> EMPTY MICROPARTICLES, FOR
EXAMPLE.
THEY DO LIKE THE DEVICE BUT
WITHOUT THE ANTIGEN OR ADJUVANT.
>> GREAT.
THANKS.
>> YES.
>> A QUESTION?
>> NOPE.
>> NOTHING ONLINE.
>> THANKS VERY MUCH.
PLEASE VOTE.
AND NOW I'D LIKE TO INTRODUCE
JOYELLE DOMINIQUE FROM OFFICE OF
GLOBAL RESEARCH, AND WHILE THIS
IS THE LAST PRESENTATION, IT
CONTAINS THREE DIFFERENT
INITIATIVES.
SO WHEN YOU'RE VOTING HERE, YOU
HAVE TO DO ALL THREE.
OVER TO YOU.
>> THANK YOU SO MUCH.
GOOD AFTERNOON.
I'M THE DIRECTOR OF THE NIAID
OFFICE OF GLOBAL RESEARCH, AND
THANK YOU TO ARAC AND DIVISION
OF AIDS FOR ALLOWING ME TO
PRESENT THESE CONCEPTS FOR
REVIEW.
I WANTED TO START BY MENTIONING
I DON'T THINK THIS AUDIENCE
WOULD HESITATE WHEN I SAY
INTERNATIONAL COLLABORATION IS
IMPORTANT, I THINK THERE ARE
MANY REASONS THAT IS THE CASE
BUT DID WANT TO MENTION WHY WE
DO BILATERAL PROGRAMS, AN
EXTENSION OF HOW WE FUND
INTERNATIONAL RESEARCH.
REAL OPPORTUNITY HERE IS BOTH
FACILITATING AND FOSTERING
COLLABORATION BETWEEN U.S. AND
FOREIGN SCIENTISTS BUT ALSO
STRENGTHENING
GOVERNMENT-TO-GOVERNMENT
RELATIONSHIPS, ESPECIALLY
COMPANIES INVESTING IN THEIR OWN
BIOMEDICAL RESEARCH.
OBJECTIVES OF BILATERAL
PROGRAMS, SPEAKING TODAY ABOUT
BRAZIL AND SOUTH AFRICA, TO
INCREASE COLLABORATIVE RESEARCH
AND TRAINING OPPORTUNITIES
BETWEEN U.S. AND THESE
SCIENTISTS .
TO INITIATE OR STRENGTHEN
LONG-TERM COLLABORATION OVER A
WIDE RANGE, TO STRENGTHEN
RELATIONSHIPS BETWEEN RESEARCH
FUNDING AGENCIES.
AND TO STRENGTHEN RESEARCH
MANAGEMENT CAPACITY OF
INVESTIGATORS IN THESE COUNTRIES
SO THEY CAN BE COMPETITIVE GOING
FORWARD FOR NIH COLLABORATION.
AND TO EXPAND FOCUS ON NIH AND
U.S. SCIENTIST-IDENTIFIED AREAS
OF RESEARCH PRIORITIES, THERE'S
AN OPPORTUNITY FOR US TO HELP
DEFINE WHAT IS THE AREAS OF
PRIORITY FOR THESE COLLABORATIVE
RESEARCH PROGRAMS.
WE DO MANAGE THESE PROGRAMS ON
BEHALF OF NIH, SO THERE ARE
MULTIPLE I.C.s THAT
PARTICIPATE IN THIS INITIATIVE
AS WELL AS THE FUNDING
ORGANIZATIONS IN THE OTHER
COUNTRIES.
SO I'LL START WITH U.S.-SOUTH
AFRICA.
THESE, ALL OF THESE ARE
REISSUES, THIS WOULD BE THE
FIRED PHASE OF OUR U.S.-SOUTH
AFRICA PROGRAM.
IT IS AN RFA, R01 FIVE-YEAR
PROGRAM, NIAID COMMITMENT FIRST
YEAR $1.25 MILLION, FIVE-YEAR
AWARDS WITH 6 TO 8 NIAID AWARDS.
WE'RE WORKING, THIS IS JUST OUR
NIAID COMMITMENT.
WE'RE WORKING ON BEHALF OF ALL
THE INSTITUTES THAT PARTNER IN
THESE INITIATIVES TO SUPPORT A
WIDE RANGE OF RESEARCH AREAS.
THESE ARE NIAID-FOCUSED RESEARCH
AREAS, ONLY NIAID, THAT I'M
PRESENTING TODAY.
WE'RE WORKING ACROSS NIH TO
GATHER INTEREST FROM THE
DIFFERENT INSTITUTES AND
CENTERS.
BUT YOU CAN SEE HERE EVEN ACROSS
NIAID WE INCLUDE ALL OF OUR
DIVISION AREAS OF INTEREST, AND
WE WOULD PROPOSE AGAIN TO MOVE
FORWARD ACROSS AS NIAID
PARTICIPATING IN THESE
INITIATIVES.
THE IMPORTANCE IN SOUTH AFRICA
IS SOUTH AFRICA HAS SKILLED
BIOMEDICAL SCIENTISTS INVESTING
IN BIOMEDICAL RESEARCH CAPACITY.
THEY ARE WORKING ON INNOVATIVE
VACCINE STRATEGIES AND OTHER
BIOLOGICS.
AND THIS WOULD ALLOW US TO HAVE
THE COMPLEMENTARY FUNDING OF A
FOREIGN BIOMEDICAL RESEARCH
ORGANIZATION.
THIS WOULD BE THE THIRD PHASE OF
THIS PROGRAM SO THE FIRST TWO
PHASES ARE JUST HIGHLIGHTED
HERE, AND I WOULD JUST NOTE THAT
THESE ARE PROGRAMS WHERE THE
FOREIGN FUNDING AGENCY FUNDS
THEIR SCIENTISTS AND NIH FUNDS
THE U.S. SCIENTISTS, IN THIS
PARTICULAR CASE SOUTH AFRICAN
MEDICAL RESEARCH COUNCIL GIVERS
NIAID THE FUNDING, NIAID ISSUES
OF THE AWARD BUT WE STRICTLY
MANAGE FUNDING SO THE
CONTRIBUTIONS OF SOUTH AFRICAN
GO TO THE SOUTH AFRICAN PI.
YOU CAN SEE THAT WE'VE HAD A
COUPLE ITERATIONS HERE BUT
OVERALL WE PLAN TO MOVE FORWARD
WITH THE R01 COMPONENT FOR THE
THIRD PHASE.
THIS HAS BEEN A PRODUCTIVE
PROGRAM, YOU CAN SEE BETWEEN THE
TWO PHASES HAVE BEEN 54 AWARDS,
AND THAT ALSO DOESN'T INCLUDE
SOME OF THE INITIATIVES THAT
WE'VE BEEN ABLE TO DO WITH THE
SOUTH AFRICAN MEDICAL RESEARCH
COUNCIL AS NIH AND FOREIGN
FUNDER TO PROMOTE RESEARCH AND
GOOD RESEARCH PRACTICES, LIKE
WRITING APPLICATIONS, ABLE TO
PARTNER WITH SOUTH AFRICAN MRC
TO HELP THEM SUPPORT THEIR
RESEARCHERS AND I THINK THIS
JUST TAKES ADVANTAGE OF THE
COLLABORATION WHERE WE CAN
REALLY ENHANCE WHAT WE'RE DOING
AND STRIVE TO CREATE VERY
WELL-POSITIONED TEAMS TO BE
COMPETITIVE FOR RESEARCH.
A FEW OF THE PUBLICATIONS YOU
SAW IN THE LAST SLIDE, AT THE
MOMENT ALMOST 300 PUBLICATIONS
FROM THE FIRST TWO PHASES OF
THIS PROGRAM.
AND THAT IS THE SECOND PHASE IS
STILL ONGOING SO WE EXPECT THAT
WILL CONTINUE TO INCREASE.
AND JUST TO MENTION I DON'T HAVE
TIME TO GO INTO ALL OF THE
DIVERSE SCIENTIFIC ACHIEVEMENTS
TODAY BUT THERE HAVE BEEN A
NUMBER THROUGHOUT THE PROGRAM.
U.S.-BRAZIL PROGRAM, AGAIN
SIMILAR LOOKING, REISSUE, RFA,
R01, FIRST YEAR COMMITMENT FROM
NIAID WOULD BE $1.25 MILLION.
AGAIN, FIVE-YEAR PROGRAM,
ANTICIPATE 5 TO 6 NIAID AWARDS.
FUNDING PARTNERS IN BRAZIL
MINISTRY OF HEALTH AND MINISTRY
OF SCIENCE, TECHNOLOGY,
INNOVATION.
AGAIN, WE HAVE MULTIPLE I.C.s
PARTICIPATING IN THIS
INITIATIVE.
AGAIN, HERE I'M HIGHLIGHTING THE
PROPOSED NIAID RESEARCH FOCUS,
YOU CAN SEE IT GOES ACROSS ALL
AREAS OF NIAID RESEARCH
PRIORITY, AND THERE IS MUCH
INTEREST IN THIS INTERFACE WITH
BRAZIL.
YOU CAN SEE WE HAVE EVEN MORE
DIVERSITY HERE, AS WELL, FOR OUR
DIFFERENT PROGRAMS.
AGAIN, BRAZIL OFFERS
OPPORTUNITIES FOR OUTSTANDING
COLLABORATIVE RESEARCH, SPECIAL
LOY AREAS THAT ARE GROWING
IMPORTANCE TO THE UNITED STATES.
WE HAVE -- THERE ARE
AVAILABLE -- ESTABLISHED AND
WELL RESOURCED SCIENTISTS FUNDED
BY THESE MINISTRIES I MENTIONED.
AND I WOULD SAY I WANT TO
EXPLAIN THIS IS THE SECOND PHASE
OF THIS PROGRAM, YOU SEE PHASE
1A AND 1B, TYPICALLY WHEN WE
START A BILATERAL PROGRAM WE
START WITH ADMINISTRATIVE
SUPPLEMENTS SO THAT'S WHAT
HAPPENED WITH THIS PROGRAM AND
THEN WE DID ISSUE A FOUR-YEAR
R01, SO THIS OFFICIALLY WILL BE
THE SECOND PHASE OF THE
U.S.-BRAZIL PROGRAM.
AND DIFFERENT FROM THE SOUTH
AFRICA MEDICAL RESEARCH COUNCIL,
NIH FUNDS THE U.S. P.I.
DIRECTLY, BRAZILIAN AGENCIES
FUND BRAZILIAN P.I. DIRECTLY, SO
NO FUNDING IS EXCHANGED IN THIS
CASE.
AGAIN WE WANT TO FOSTER THESE
RELATIONSHIPS BETWEEN U.S. AND
BRAZILIAN SCIENTISTS, AND ALSO
TAKE ADVANTAGE OF WHAT IS AN
EXPANDING AND GROWING
OPPORTUNITY IN BRAZIL FOR
RESEARCH.
THERE IS NEW ADMINISTRATION IN
BRAZIL THAT IS VERY PRO SCIENCE
AND WE HAVE SOME OPPORTUNITIES
TO REALLY WORK WITH OUR
BRAZILIAN COUNTERPARTS TO FIND
THESE AREAS AND LEVERAGE OUR
MUTUAL INTEREST TO MOVE SCIENCE
FORWARD.
YOU CAN SEE HERE PHASE 1A WAS 19
SUPPLEMENTS, PHASE 1B ABLE TO
AWARD 12 AWARDS, AGAIN THESE ARE
STILL ONGOING AND WE'RE
CONTINUING TO LOOK AT THE
OPPORTUNITIES AND OUTCOMES OF
THESE INITIATIVES.
WE'LL ALSO HIGHLIGHT THOSE
SPECIFICALLY IN THE CASE OF
BRAZIL, OPENING OF GOVERNMENT TO
GOVERNMENT RELATIONSHIPS,
FUNDING TOGETHER AT PARTNERS,
WAS REALLY LEVERAGED DURING THE
ZIKA OUTBREAK AND I THINK THAT
GOES FOR ANY OUTBREAK,
RELATIONSHIPS THAT ARE
ESTABLISHED DURING THESE
PARTNERSHIPS REALLY CONTRIBUTE
TO WHAT WE CAN DO DURING
OUTBREAKS AND HOW WE CAN MOVE
SCIENCE FORWARD.
IT HELPS US TO PUT FORWARD AREAS
OF CHALLENGES WITH GLOBAL
RESEARCH, FOR EXAMPLE, SAMPLE
AND DATA SHARING AND BE ABLE TO
OPEN CONVERSATIONS ON A
PARTNER-TO-PARTNER LEVEL TO TRY
TO ENHANCE NOT ONLY THE
INDIVIDUAL PARTNERSHIPS BUT
REALLY THE GLOBAL PARTNERSHIP
BETWEEN OUR COUNTRIES.
TO HIGHLIGHT SITUATION CAN'T
PUBLICATIONS THAT CAME OUT OF
THIS U.S.-BRAZIL INITIATIVE.
I'D LIKE TO THANK DR. ABRAMS AND
DR. PETTIFOR FOR REVIEWING,
THERE WAS ENTHUSIASM FOR
CONTINUING PROGRAMS.
WE DISCUSSED CHALLENGES AS WELL
THAT GRANTEES IN SOUTH AFRICA
AND BRAZIL WOULD BENEFIT FROM
CONTINUING TO DEVELOP THEIR
CAPACITY TO MANAGE NIH RESEARCH
GRANTS AND WE SEE THAT WIDELY IN
SOME OF OUR FOREIGN RESEARCH
PARTNERS.
AND I THINK THIS IS AN
OPPORTUNITY TO HELP WITH THAT
AND AS I MENTIONED WE HAVE A LOT
OF PARTNER PROGRAMS THAT WORK
UNDER THIS INITIATIVE THAT CAN
HELP FACILITATE THAT
DEVELOPMENT.
FOR EXAMPLE WITH THE FOGARTY
INTERNATIONAL CENTER.
THERE ARE A NUMBER OF CHALLENGES
WITH BILATERAL COLLABORATIVE
RESEARCH PARTNERSHIPS INCLUDING
ADMINISTRATION AND
ADMINISTRATIVE AND FINANCIAL AN
WE DISCUSSED SOME OF THIS,
RESEARCH IS EXPENSIVE AND SOME
OF THESE COUNTRIES, AND ALSO
THERE IS NOT ALWAYS THE SAME
TYPE OF SUPPORT THAT A U.S.
INSTITUTION MIGHT PROVIDE A
RESEARCHER SO THAT CAN BE A
CHALLENGE TO THE PARTNERSHIP.
FINDING WAYS AGAIN TO LEVERAGE
THE RELATIONSHIP AND ENCOURAGING
FUNDING PARTNERS TO PROVIDE SOME
SUPPORT TO DEVELOP OVERALL
COMPREHENSIVE CAPACITY I THINK
IS AN ADVANTAGE OF THIS PROGRAM.
AND THEN THEY ASKED FOR A LITTLE
BIT MORE OF A SUMMARY OF THE
PREVIOUS PHASES OF THE PROGRAM
WHICH I HOPE I PROVIDED TODAY.
BUT I WOULD BE HAPPY TO TAKE ANY
ADDITIONAL QUESTIONS AND JUST TO
HIGHLIGHT AGAIN THE TWO PROGRAMS
BUT, AGAIN, THREE CONCEPTS SO
SOUTH AFRICA HAS TWO CONCEPTS
BECAUSE WE HAVE AN HIV SPECIFIC
NOFO AND WE WOULD HAVE A NON-HIV
SPECIFIC NOFO, THOSE ARE TWO
CONCEPTS, AND THE THIRD WOULD BE
FOR BRAZIL.
THANK YOU VERY MUCH FOR ALLOWING
ME TO PRESENT THESE AND I'M
HAPPY TO TAKE ANY QUESTIONS.
>> THANK YOU.
MONICA, YOU HAVE A QUESTION?
>> YEAH, THESE ARE SUCH GREAT
INITIATIVES.
MY ONLY QUESTION WAS ON THE
SOUTH AFRICA ONE WAS ABOUT
MALARIA THAT I DIDN'T SEE ON THE
LIST, MAYBE THAT WASN'T
COMPREHENSIVE BECAUSE I SAW SO
MANY COMPREHENSIVE, DENGUE AND
THE IDEA OF ARBOVIRUSES IN
BRAZIL, AND THEN ALSO CHOLERA
OUTBREAKS OR OTHER OUTBREAKS
THAT ARE KIND OF THERE AND COME
BACK, IS IT COMPREHENSIVE, YOUR
LIST?
>> WE JUST HAD A MEETING WITH
OUR BRAZILIAN COUNTERPARTS THIS
MORNING WHERE WE SHARED ABOUT
THREE PAGES WORTH OF POTENTIAL
AREAS FOR COLLABORATION.
SO, I THINK THERE IS STILL A LOT
OF TIME FOR DISCUSSION AND
REFINEMENT OF THE AREAS OF
PRIORITY, AND SOME OF IT HAS
JUST BEEN IN THE PRIOR FOCUS OF
THE NOFO BUT WE'RE ALWAYS OPEN
TO DISCUSSING IMPORTANT AREAS OF
COLLABORATION ESPECIALLY FOR THE
U.S. SCIENTISTS THAT WANT TO
ENGAGE IN THESE COUNTRIES SO
I'LL TAKE THAT BACK TO OUR
DEVELOPING COMMITTEE AND MAKE
SURE THOSE ARE CONSIDERED.
>> OTHER QUESTIONS?
>> I ASSUMED SCIENTISTS FROM
THESE AREAS THAT WE'RE
COLLABORATING WITH, BRAZIL AND
SOUTH AFRICA, ARE INVOLVED WITH
THAT, THOSE LISTS OF RESEARCH
FOCUS AREAS.
>> ABSOLUTELY.
>> INTENTIONAL DELIBERATE
MEANINGFUL WAY.
>> ABSOLUTELY.
THESE ARE DEVELOPED, ONE OF THE
REASONS THESE PROGRAMS TAKE A
LONG TIME TO DEVELOP AND A LONG
TIME TO IMPLEMENT IS BECAUSE
THERE ARE MANY, MANY LEVELS OF
NEGOTIATIONS, WE'RE WORKING
ACROSS NIH AS WELL AS WITH
FUNDING AGENCIES IN DIFFERENT
COUNTRIES THAT ARE GOING THROUGH
THEIR DELIBERATION PROCESSES AND
THEIR STRATEGIES, SO IT TAKES
MULTIPLE MEETINGS TO COME
TOGETHER AND MAKE SURE WE'RE ALL
ALIGNED AND BECAUSE WE DO WANT
TO MAKE SURE THERE'S MUTUAL
INTEREST, WE DON'T WANT TO ONE
SIDE INTERESTED AND WE PUT IT
FORWARD, THERE'S A LOT OF
DISCUSSION AND INPUT FROM ALL
THE STAKEHOLDERS THAT ARE
INVOLVED.
>> THANK YOU.
>> THIS IS REALLY COOL.
I THINK VERY MUTUALLY
BENEFICIAL, FROM OUR POINT OF
VIEW ALLOWS RESEARCH THAT WOULD
BE DIFFICULT TO DO WITHOUT THESE
PARTNERSHIPS.
MY QUESTION, BRAZIL AND SOUTH
AFRICA, ARE THOSE THE ONE WE'RE
SEEING TODAY OR DO THEY EXIST
FOR MULTIPLE COUNTRIES AROUND
THE WORLD?
>> THE OTHER COUNTRY WE HAVE
PARTNERED WITH, BILATERAL
PROGRAM, THESE OFFICIAL NIH
MECHANISMS, WAS CHINA.
THAT ONE IS CURRENTLY ON HOLD.
BUT WE'RE HOPING THAT EITHER
THAT ONE OR POTENTIALLY OTHER
COUNTRIES MIGHT BE SELECTED.
THESE ARE SMALL PROGRAMS, WE
HAVE A SMALL AMOUNT OF FUNDED
DEDICATED TO BILATERAL PROGRAMS,
WE TRY TO THINK ABOUT HOW WE
ENGAGE AND WHO WE ENGAGEW MAKE
SURE THEY HAVE FUNDING TO BRING
TO THE TABLE, IT'S IMPORTANT
THEY ARE INVESTING IN BIOMEDICAL
RESEARCH CAPACITY, SO THERE IS
INTERFACE MY OFFICE DOES WITH
FOREIGN COUNTERPARTS IN MANY
COUNTRIES BUT THESE ARE THE MOST
FORMAL PROGRAMS THAT WE HAVE
THUS FAR.
>> HI.
THANKS SO MUCH.
THAT WAS GREAT.
I KNOW YOU HAD IT UP THERE BUT
I'M GOING TO BE LIKE A BROKEN
RECORD.
SO THE CAP IS 300,000 A YEAR
WHICH THESE ARE BOTH COUNTRIES
THAT ARE EXPENSIVE TO WORK IN,
AND SO WE HAVE ADVOCATED FOR
INCREASING TO THE U.S. 500K FOR
AN R01, I WORRY REVIEWERS IF
THEY ARE GOING TO EXPECT R01
LEVEL SCIENCE COMING OUT OF
THIS, IT'S JUST REALLY -- IT'S
HARD EVEN TO FIT WHEN YOU'RE
PUTTING IN 500,000 CAP FOR AN
R01 IN SOUTH AFRICA TO MAKE IT
FIT.
SO JUST KEEPING THAT IN MIND
THAT TO ME THIS IS LIKE R34,
VERY SMALL R01, IF WE'RE TALKING
300,000.
SO IT'S JUST CHALLENGING.
SO YEAH.
>> ABSOLUTELY.
I WILL SAY THAT WE HAVE ALREADY
HAD DISCUSSIONS WITH OUR FOREIGN
COUNTERPARTS ON WHAT WE CAN DO
TO DISCUSS HOW WE CAN TAKE THIS
FORWARD AND SEE IF MAYBE IT
WOULD BE WORTH WHILE TO HAVE A
BIGGER INVESTMENT IN A SMALLER
NUMBER OF PROGRAMS, THOSE
DISCUSSIONS ARE ALREADY
UNDERWAY.
>> IT SEEMS YOU SHOULD BE
CONGRATULATED FOR LEVERAGING ALL
OF THESE DIFFERENT PARTIES TO
GET SUCH FUNDING AS YOU HAD.
IF THERE ARE NO OTHER QUESTIONS,
I THANK YOU.
VOTE.
AND PLEASE VOTE, VOTE FOR ALL
THREE.
MAKE SURE YOU PUT YOUR VOTE IN
FOR ALL OF THE PRIOR ONES.
ONCE YOU'VE DONE THAT --
>> WHILE YOU'RE IN THE PROCESS
OF FINISHING YOUR VOTING, I NEED
ONE LAST EN BLOC ACTION FROM THE
COMMITTEE TO ACCEPT ALL OF THE
RECOMMENDATIONS MADE BY THE
MEMBERS TODAY.
IF I COULD HAVE A MOTION TO
ACCEPT THE ENTIRE ARAC AGENDA.
AS FAR AS I CAN TELL EVERYTHING
WAS APPROVED.
IF I COULD HAVE A MOTION, A
SECOND, AND A SHOW OF HANDS.
THAT WOULD BE GREAT.
>> I MOVE.
>> SO APPROVED.
ALL IN FAVOR?
THANK YOU VERY MUCH.
ONCE WE'RE DONE VOTING, ELAINE
CAN OFFICIALLY CLOSE THE
MEETING.
>> OFFICIALLY CLOSE THE MEETING.
WE'LL SEE EVERYBODY IN JANUARY,
VIRTUALLY.
THANKS, EVERYONE, FOR YOUR TIME,
ATTENTION, AND GREAT
PRESENTATION.