I AM JEANNE MARRAZO, I AM
THE DIRECTOR OF THE NIAID, AND
AS YOU KNOW DURING THE OPEN
SESSION, WE'RE JOINED BY
REPRESENTATIVES FROM
PROFESSIONAL AND LAY
ORGANIZATIONS WHO SHARE
INTERESTS AND ACTIVITIES IN HAD
COMMON WITH THE MISSION OF THE
INSTITUTE AND AS ALWAYS WE
WELCOME THEM AND I WANT TO THANK
EVERYBODY VERY, VERY DEEPLY FOR
MAKING IT HERE IN PERSON AND
LUCKILY THE WEATHER COOPERATED
AND HOPEFULLY YOU'RE ENJOYING
THE BEAUTIFUL FALL D. C.
WEATHER.
FIRST THING I WOULD LIKE TO DO
TODAY IS A SAD 1 WHICH IS TO SAY
GOODBYE TO 3 OF OUR COUNCIL
MEMBERS WHO ARE RETIRING AFTER 4
YEARS OF SERVICE, I KNOW 4 YEARS
ENCOMPASSED THE PANDEMIC, WE
WERE JUST TALKING ABOUT IT, IT
SEEMS LIKE A BLACK HOLE.
THEIR TERMS ENDS ON
OCTOBER 31st AND WE HAVE SOME
ACKNOWLEDGMENT OF THEIR
PARTICIPATION, FIRST PERSON I
WOULD LIKE TO GET ON THE SCREEN,
CAN WE GET DR. BOCKENSTEDT ON
THE SCREEN OR DO WE ASK TO SEE
IF SHE'S THERE TO SAY HELLO
LIPPED ON ARE YOU THERE?
>> YES, I AM HERE, GREAT TO BE
WITH THE GROUP.
>> THANK YOU.
THANK YOU FOR COMING.
>> IT'S BEEN A VERY WONDERFUL
EXPERIENCE AND A LEARNING
EXPERIENCE, TOO.
IT'S GREAT TO BE PART OF THIS.
>> WELL WE REALLY APPRECIATE IT
AND WE REALLY NEED YOU.
SO WITH THAT I AM GOING TO
INVITE DR. KEITH JEROME AND
DR. STEPHANIE TAYLOR UP AND WE
WILL PRESENT THEM WITH THEIR
PLAQUES AND LINDSAY DRAPER AWE
WILL GET YOURS TO YOU.
AND THEN I WILL LIKE TO WELCOME
OUR ADHOC COUNCIL MEMBERS THAT
ARE ATTENDING AT THIS TIME.
THANK YOU FOR JOINING US, WE
HAVE [INDISCERNIBLE] WHO IS FROM
COLUMBIA MEDICAL CENTER, WALK
WIN ESPIN OOSA FROM THE SCHOOL
OF MEDICINE AND [INDISCERNIBLE]
FROM THE RESEARCH INSTITUTE.
APPRECIATE YOU BEING HERE TODAY
SO THANK YOU.
SO THE FIRST ITEM OF BUSINESS AS
IEWSH IS TO REVIEW AND APPROVE
THE MINUTES FROM THE LAST
MEETING.
YOU SHOULD HAVE ALREADY SEEN A
COPY OF THOSE MINUTES IN THE
ELECTRONIC COUNCIL BOOK, ASK
ANYONE HAVE ANY CORRECTIONS TO
THE MINUTES?
DOES KIDNAP HAVE ANY QUESTIONS
OR CONCERNS ABOUT THE CONCEPTS
PRESENTED AT THE PREVIOUS
MEETING?
IF NOT, MAY I HAVE A MOTION FOR
APPROVAL?
GOOD.
MOMENT OF FEAR THERE.
IS THERE A SECOND?
OKAY, ALL IN FAVOR OF THE
MINUTES PLEASE SAY AYE.
ANY OPPOSED?
THANK YOU.
SO WE WILL MOVE FORWARD AND I
WANT TO JUST POINT OUT NOW SOME
STAFF CHANGES AND YOU WILL NOT
HEAR ABOUT ALL OF THEM, SOME OF
THEM I LEFT TO DR. PEARSON ON
WHO WILL TALK ABOUT THE VACCINE
RESEARCH CENTER RIGHT AFTER ME,
THE FIRST PERSON TO NOTE IS
CAROLINE HUTTER WHO HAS BEEN
NAMED DIRECTOR OF THE NIH OFFICE
OF STRATEGIC COORDINATION, THIS
IS A BIG OFFICE WHICH MANAGES
AND OVERSEES ACTIVITIES FUNDED
BY THE COMMON FUND WHICH HAS A
BUDGET OF NEARLY $700 MILLION
ACROSS ALL AREAS OF INSTITUTE
RESEARCH.
WE ALSO ARE VERY EXCITED TO
ANNOUNCE DR. JERRY
[INDISCERNIBLE] WHO HAS BEEN
NAMED AS THE DIRECTOR OF THE NIH
OFFICE OF AIDS RESEARCH AFTER A
NATIONAL SEARCH.
JERRY IS A CLINICAL PSYCHOLOGIST
CURRENTLY AT THE UNIVERSITY OF
ILLINOIS CHICAGO, PROFESSOR OF
PEP DEEMIOLOGY AND BIOSTATISTICS
IN CASE YOU HAVE IMPOSTER
SYNDROME THIS MORNING AND HAS
BEEN WORKING IN THIS FIELD FOR A
REALLY LONG TIME SO VERY EXCITED
TO HAVE HER JOIN AND SHE WILL BE
STARTING, I BELIEVE NEXT MONTH.
ALONG THE LINES OF TRANSITIONS
AND ANOTHER VERY SAD BUT FOR
HUGH PROBABLY VERY HAPPY
ANNOUNCEMENT.
DR. OPPENCLAUS IS LEAVING US
AFTER 18 STELLAR YEARS AS
PRINCIPAL DEPUTY DIRECTOR.
SO LET'S GIVE HUGH A GIGANTIC
ROUND OF APPLAUSE.
NOT ONLY WAS HUGH PRINCIPAL
DEPUTY DIRECTOR DURING THAT TIME
BUT HE ALSO SERVED AS ACTING
DIRECTOR AFTER DR. FAUCI RETIRED
AND I HAVE THE INCREDIBLE GOOD
FORTUNE TO COME ON BOARD WITH
YOU AND MENTORED BY HIM, IN THE
PAST YEAR WE HAVE A LOT OF
OPPORTUNITIES TO CELEBRATE YOU
IN THE COMING MONTHS SO STAY
TUNED IF ARE THAT AND WE WON'T
LET HIM GET VERY FAR.
THERE ARE A FEW THINGS I WILL
MENTION, PART OF MY FOCUS IN THE
LAST COUPLE OF MONTHS AS I'VE
GOTTEN MORE SETTLED AS BEEN TO
CONTINUE TO BUILD MY TEAM, MY
LEADERSHIP TEAM IN THE OFFICE OF
THE DIRECTOR.
I WILL JUST MENTION 3 KEY
PEOPLE, BOB ISENGER, IS HERE,
MANY OF YOU KNOW HIM, HE'S BEEN
WITH NIAID FOR MANY YEARS.
ACTING DIRECTOR OF THE OFFICE OF
AIDS RESEARCH FOR SOMETIME,
MOSTLY RECEIPTLY ACTING DEPUTY
DIRECTOR TO DR. TABAK WHEN HE
WAS THE ACTING NIH DIRECTOR AND
WE'VE BEEN VERY FORTUNATE TO
SECURE HIM AS MY SENIOR ADVISOR
AND HE'S BECOME ESSENTIAL IN THE
FUNCTIONING OF OUR TEAM.
LUCAS BUYON A RECENT MANAGEMENT
FELLOW GRADUATE WHO IS NOW A
HEALTH SCIENCE POLICY ANALYST
AND SCIENTIFIC SPECIFIC
ASSISTANT WITH ME WITH AN
INTEREST IN BIOSECURITY IN
PARTICULAR.
AND THEN INCREDIBLY LOOKY TO
HAVE TARA P A LMORE WHO MANY OF
YOU MAY KNOW FROM HER WORK AS A
HOSPITAL EPIDEMIOLOGIST, EXPERT
IN A NUMBER OF EMERGING
INFECTIONS INCLUDING EBOLA
VIRUS, MPOX, SHE'S BECOME A
SENIOR MEDICAL ADVISOR FOR
PRIMARILY EMERGING INFECTIONS
AND HAS BEEN REALLY INSTRUMENTAL
IN HELPING DEAL WITH THE H5 M1
AND MPOX SITUATIONS.
SO MORE TO COME ON THAT.
REALLY HAPPY TO NOTE THAT CEASAR
[INDISCERNIBLE] IS NOW THE NEW
DIRECTOR OF THE VACCINE RESEARCH
PROGRAM.
MANY OF YOU MAY KNOW CEASAR.
HE HAS OVER 25 YEARS OF
EXPERIENCE IN THIS SPACE AND
HE'S ACTUALLY SERVED AS CHIEF
PRECLINICAL RESEARCH AND
DEVELOPMENT SINCE 2020 SO
WELCOME TO CEASAR IN THIS
OFFICIAL CAPACITY.
BRUCE BURNETT IS THE NEW BRANCH
CHIEF IN THE OFFICE OF
REGULATORY AFFAIRS, HE ALSO HAS
25 YEARS IN LEADERSHIP OF
RELEVANT AREAS HERE AND HE'S
BEEN A BIG SUPPORTER OF NIH
RESEARCH COMPLIANCE, REALLY
IMPORTANT ROLE, DELIGHTED TO
HAVE HIM AND LAST IN TERMINGS OF
STAFF, CHELSEA BOYD WHO I THINK
IS HERE, THERE SHE IS HAS BEEN
NAMED THE DIRECTOR OF OFFICE OF
RESEARCH AND POLICY AND
OPERATIONS WITHIN THE DIVISION
OF EXTRAMURAL ACTIVITIES.
SHE'S BEEN AT NIAID SINCE 2016,
FIRST HAS A SCIENTIFIC REVIEW
OFFICER IN THE SCIENTIFIC REVIEW
WRITING PROGRAM.
SO REALLY GREAT TO HAVE THESE
FOLKS.
SO THOSE ARE THE STAFF UPDATES,
I AM NOW GOING TO SHOW YOU A
SERIES OF PHOTOGRAPHS WHICH ARE
JUST SOME, I THINK VISUAL
STIMULATION AND SOME MAYBE FUN
REPORTS ON WHAT WE'VE BEEN DOING
AND HOW I'VE BEEN BEING KEPT
BUSY, SINCE THE LAST TIME WE MET
AND I WILL CONTEXTUALIZE SOME OF
THESE, I HAD A WONDERFUL VISIT
TO THE WHIT MAN WALKER CLINIC IN
D. C.
SOME OF YOU MAY KNOW, THIS IS
MORE THAN A CLINIC, IT'S MORE OF
A COMMUNITY HEALTH RESEARCH
CENTER, IT'S A RESEARCH BASED
SITE, IT'S BEEN CRITICAL FOR US
IN THE PRACTICE OF HIV, CLINICAL
RESEARCH AND PREVENTION STUDIES
AND ALSO A TRAINING GROUND.
THEY NOW HAVE LOTS OF
OPPORTUNITIES FOR PEOPLE TO
TRAIN IN COMMUNITY BASED HEALTH
ORIGINALLY STARTED AS AN
HIV-LGBTQ TRUSTEES BUT HAS GROWN
TO BECOME A WONDERFUL FACILITY
BASE FACILITY SO DR. BERTAGNOLLI
WENT THERE, GOT OUR T-SHIRTS AND
HAD A GREAT VISIT IN CELEBRATION
OF PRIDE MONTH.
THAT WAS REALLY LOVELY.
I HAVE BEEN TRYING TO GET TO
KNOW AND SPEND A LITTLE BIT MORE
TIME WITH OUR CLINICAL FELLOWS.
I TRY TO ROUND THE CLINICAL
CENTER AT LEAST A COUPLE TIMES A
MONTH, USUALLY I MAKE IT ABOUT
THAT AND THIS IS JUST A MEETING
WITH THEM, THEY ARE A WONDERFUL
GROUP OF PEOPLE WITH A LOST I
WOULD SAY AMBITION AND VERY
EXCITED TO BE HERE.
SO IT'S WONDERFUL TO SEE THEM.
I HAD THE OPPORTUNITY TO COME
HERE, JUST A COUPLE WEEKS AGO
SEEMS LIKE IT WAS MORE RECENT
THAN JULY BUT IT COULD HAVE BEEN
AND LEE HALL AND HIS GROUP
HOSTED ME FOR A BRIEFINGS ON
THEIR WORK IN THE VECTOR BORNE
DISEASES BRANCH AND IT JUST
HAPPENED TO BE WORLD MOSQUITO
DAY WHICH IS REALLY QUITE
AWESOME, THIS GROUP AS YOU'RE
GOING TO HEAR TODAY IS DOING
INCREDIBLE WORK, ON DISEASES
THAT JUST DO NOT SEEM TO WANT TO
GIVE US A BREAK THESE DAYS CROSS
DAYS--SO
THAT WAS REALLY EXCITING.
I HAD THE OPPORTUNITY TO VISIT
THE GATHERSBURG AND RESEARCH
FACILITIES AND IF YOU HAVE NOT
HEARD ABOUT THIS, THIS IS A
PRETTY REMARKABLE ASSET THAT
NIAID HAS.
IT REALLY HAS FACILITATED OUR
ABILITY TO NOT JUST GET PRODUCTS
FROM THE BEVEN TO THE
LABORATORY, BUT TO THE
MANUFACTURING FACILITY AND TO
COMMUNITIES AND MANUFACTURES,
IT'S INN BELIEVABLE, SO WE VISIT
THE VACCINE IMMUNOLOGY PROGRAM,
PRODUCTION PROGRAM AND THE
CLINICAL MATERIALS PROGRAM AS
SHOWN HERE AND THIS IS JUST
REALLY AN EXAMPLE OF HOW IT
WORKS AND AS YOU'LL PROBABLY
HEAR A LITTLE BIT FROM THEM, THE
BASIC RESEARCH OF COURSE STARTS
IN THE BUILDING, BUILDING 40.
THERE'S A PROCESS DEVELOPMENT IN
THE PRODUCTION PROGRAM THAT THEN
GOES ON TO CLINICAL MATERIALS
PROGRAM FOR CGMP MANUFACTURE,
AND THEN CAN PREPARE PRODUCT FOR
USE IN VACCINE CLINICAL TRIALS
AND THEN OF COURSE, ALL UNDER
GIRDED BY THE DEVELOPMENT OF THE
RELEVANT ASSAYS, TO SEE IF THE
PRODUCTS ACTUALLY WORK AND TO
MEASURE RESPONSE.
THIS IS AN ECOSYSTEM THAT IS
REALLY UNUSUAL WHEN YOU THINK
ABOUT HOW INDUSTRY WORKS, HOW
ACADEMICS WORK AND TO BE ABLE TO
HAVE THIS REALLY ENCLOSED SYSTEM
IS VERY SPECIAL AND HAS
FACILITATED JUST A LOT OF GREAT
DISCOVERY AND TRANSLATIONAL
SCIENCE.
I HAVE BEEN MEETING WITH A LOT
OF FOLKS HERE IN TOWN, JUST A
FEW SORT OF EXAMPLES OF WHAT I
CALL SCIENTIFIC DIPLOMACY, WHICH
I THINK AS I MAY HAVE TOLD SOME
OF YOU TURNS OUT TO BE A VERY
IMPORTANT PART OF THIS JOB.
WE'VE HAD MEETINGS WITH THE
MINISTRY OF SCIENCE AND
TECHNOLOGY FOR THE PEOPLE'S
REPUBLIC OF CHINA, COLLEAGUES
FROM OFF THE RAILIA, --AUSTRALI,
JAPAN, W. H. O.'S TEAMS, MOST
RECENTLY DR. JEROME SOLOMON WHO
I SAW AT THE MUNICH MIS MEETING
ON A PANEL ON TB CONTROL WHICH
WAS ORGANIZED BY W. H. O. AND
OTHERS SO THESE WERE REALLY,
REALLY TERRIFIC, GREAT TIEWPTS
TO SEE WHAT OTHERS ARE DOING.
I SPENT 8 DAYS IN SOUTH AFRICA
IN AUGUST, AND IT'S A BIT
DECEPTIVE BECAUSE IT WAS REALLY
4 WORKS DAYS BECAUSE THERE WAS A
LONG HOLIDAY WEEKEND SO BETWEEN
WEDNESDAY AND THURSDAY AND
MONDAY AND TUESDAY, WE DID ALL
OF THESE VISITS AND I WILL TELL
YOU, I ALWAYS REMEMBER, KARL AT
1 POINT YOU TOLD ME THAT TONY
RAN A MARATHON EVERY DAY AND I
DIDN'T REALLY UNDERSTAND WHAT
THAT MEANT BUT THIS WAS AN
EXAMPLE OF REALLY I FELT LIKE I
WAS RUNNING A PARATHON EVERY
DAY, IT WAS FANTASTIC, WE GOT TO
JO HAN ESTIMATE THAD BURG AND
[INDISCERNIBLE], AND GOT TO SEE
THOSE, THE STELLENBOSCH,
UNIVERSITY, AND 1 OF THE LARGEST
IN THE WORLD FOR TB STUDYING AND
THEY PROVIDE CARE TO PEOPLE WHO
ARE STRUGGLING WITH ADDICTION,
AND WAS AN AMAZING REALLY,
REALLY INSPIRING SITE AND THEN
IN CAPE TOWN, YOU KNOW WE HAVE A
NUMBER OF MANY PROGRAMS IN CAPE
TOWN, JUST A COUPLE OF
HIGHLIGHTS WERE
STELLENBOSCH CENTER FOR TB, AND
THE [INDISCERNIBLE] WHICH IS 1
OF OUR IMPACT SITES TALKS TO
PEOPLE IN THE TRIALS AND
INCLUDING YOUNG PEOPLE WHO ARE
ABLE TO ACCESS FOR EXAMPLE, LONG
ACTING RETROVIRAL THERAPY OR
LONG ACTING PREVENTION AND
HEARING ABOUT THE IMPACT ITS
MADE ON THEIR LIVES AND HOW THEY
WISH THEY COULD GET THESE PROD
UBTS FOR EVERYBODY AND THEIR
FAMILY WHO NEEDS THEM, OR
EVERYBODY IN THEIR PEER NETWORK,
REALLY INSPIRING, INCREDIBLE
WORK ANYTHING ON THERE, ALSO I
HAD THE OPPORTUNITY TO MEET THE
CONSUL GENERAL WHO RECENTLY
JOINED AND SHE WAS VERY, VERY
EXCITED ABOUT THE WORK AND THE
INVESTMENT THAT WE HAVE MADE IN
SOUTH AFRICA OVER THE YEARS.
WHEN WE LOOKED AT THE OVERALL
INVESTMENT, WE ESTIMATE THAD
IT'S BEEN OVER A BILLION U.S.
DOLLARS IN SOUTH AFRICA, IN THE
LAST RELEVANT YEARS, SO IT'S
REALLY A WONDERFUL PLACE, AND
LASTLY I VISITED THE HVTN
IMMUNOLOGY LABORATORY WHICH FOR
ALL THE WORLD LOOKS LIKE FRED
HUCH, INCREDIBLE, INCREDIBLE
PATHWAY GIVES SILLITY TO HAVE IN
THE MIDDLE OF CAPE TOWN.
JUST AN AMAZING TEAM AND THEN
THESE ARE JUST SOME OF THE
PICTURES FROM THAT, THE UPPER
RIGHT IS THE DROP-IN CENTER I
MENTIONED.
UPPER LEFT IS A MEETING WITH THE
YOUNG INVESTIGATORS IN THE HIV
CURE TEAM WHICH WAS GREAT.
THEIR FIRST QUESTION TO ME WAS,
AFTER I HAD TO PROD THEM FOR A
WHILE TO TO FEEL LIKE THEY WERE
COMFORTABLE ASKING QUESTIONS,
THEIR OTHER QUESTION WAS DOES IT
GET ANY EASIER, SO IT WAS A VERY
INTERESTING QUESTION, SO THEY
REARLY ARE, YOU KNOW STRUGGLING,
THINKING ABOUT FUNDING, TRYING
TO FIND THEIR WAY AS EARLY
INVESTIGATORS, AND JUST A
REALLY, WONDERFUL DIVERSE
COMMITTED GROUP OF YOUNG SOUTH
AFRICAN PEOPLE.
SO LET'S--THAT'S JUST A REALLY A
SMATTERING OF ALL THE STUFF
THAT'S BEEN GOING ON.
WE COULD SHOW YOU A LOT OF
REALLY NICE PHOTOS ALL MORNING
BUT WE HAVE TO UNFORTUNATELY
TALK ABOUT MONEY.
SO THIS, THIS IS THE SLIDE THAT
EVERYBODY HAS, I THINK SEEN
SEVERAL TIMES, THAT SHOWS OUR
FUNDING LEVELS FROM 2000-2025,
REMEMBER THAT APPARENT DROP IN
2013 THAT WAS NOT REALLY A DROP,
THAT WAS DUE TO THE FACT THAT
THE GLOBAL FUND MONEY NO LONGER
PASSED THROUGH NIAID AND WE HAVE
RECEIVED PRETTY MUCH STEADY
INCREASES UNTIL FISCAL YEAR
2024.
SO FOR FY 2025 BUDGET, THE
PRESIDENT SUBMIT TODAY TO
CONGRESS ON MARCH 11th AND
PROPOSED AN OVERALL INCREASE FOR
NIH OF 5.6% OR 2.76 BILLION
ABOVE THE FY2024 ENACTED LEVEL.
HOWEVER, OUR BUDGET AND MOST
OTHER IC BUDGETS REMAIN FLAT
WITH THE FY2024 ENACTED BUDGET.
THE HOUSE IN THE SECOND COLUMN,
SUBMITTED THE BUDGET ON
JULY 9th AND MAY HAVE HEARD
THAT THEY PROPOSED THAT OUR
FUNDING FOR 2025 BE SPLIT INTO 2
ICs, THE NATIONAL INSTITUTE ON
INFECTIOUS DISEASES AND AND THE
NATIONAL INSTITUTE ON IMMUNE
SYSTEM AND ARTHRITIS.
THE SENATE WHICH IS IN THE
FOURTH COLUMN THERE SUBMITTED
THE FY2025 BUDGET ON
AUGUST 1st SO SUCH SUGGESTION
THAT WE SPLIT AND THEY PROPOSED
130 MILLION-DOLLAR INCREASE FOR
US OVER FY2024 WHICH IS A 2%
INCREASE.
SO JUST TO KEEP YOU AWARE OF
WHAT'S GOING ON, WE WILL SEE
WHAT HAPPENS.
OBVIOUSLY WITH THE ELECTION
COMING UP, WE SUSPECT WE WILL
PROBABLY BE UNDER A CONTINUING
RESOLUTION BUT THAT'S WHAT WE
HAVE ON THE TABLE.
A COUPLE WORDS ABOUT EAR MARKS
AS YOU MAY KNOW, EAR MARKS LIMIT
OUR FLEXIBILITY TO ALLOCATE
ADDITIONAL FUNDS TO OTHER NIAID
PRIORITIES.
WE ARE REQUIRED TO SPEND THIS
MONEY UNDER THE AH SPICES OF THE
TOPIC THAT THE MONEY IS EAR
MARKED TOO, HENCE THE NAME.
THE NEW TARGET RESEARCH
REQUIREMENTS IN FY2025 ARE
LISTED THERE FOR BOTH THE HOUSE
AND THE SENATE AND YOU CAN SEE
FY24 ENACTED FOR REFERENCE, BOTH
THE HOUSE AND THE SENATE
PROPOSED A 25 MILLION-DOLLAR
INCREASE TO TICK-BORNE DISEASE
TARGET MAKING IT 125 MILLION,
25% HIGHER THAN WHAT WAS ENACTED
IN FY2024, AND IN FY2025, THE
SENATE PROPOSED $80 MILLION FOR
FUND NOTHING ANTIVIRAL DISCOVERY
CENTERS OR AVIDS AND ALSO
PROPOSED ADDITIONAL FUNDING OF
$10 MILLION TO THE NATIONAL
BIOCONTAINMENT LABORATORIES TO
REACH A TOTAL OF $3 MILLION.
SO CAN YOU SEE OUR TOTAL EAR
MARK INCREASED THERE, IS
52 MILLION AND TOTAL OVERALL IS
A LITTLE OVER A BILLION.
JUST A COMMENT ABOUT SOME OF OUR
LEGISLATIVE ACTIVITIES.
I WILL TALK A LITTLE BIT ABOUT
LONG COVID LATER BUT TO
HIGHLIGHT ON JUNE 21st, THE
OFFICE OF LEGISLATIVE POLICY AND
ANALYSIS HELD A LUNCH AND LEARN
ON LONG COVID FOR GRNGAL STAFF
ON WHERE WE ARE @ NIH HAD LONG
COVID, THERE WERE A NUMBER OF
PEOPLE INCLUDING
DR. BERTAGNOLLI, INCLUDING
DR. JOE GREEN FROM THE DIVISION
OF AIDS, DAIT AND DR. WALTER
KOROSCHWETZ, WHO IS THE NINDS
DIRECTOR.
THAT WAS VERY HELP EMPLOY ON
JULY 10th I WENT WITH A NUMBER
OF PEOPLE FROM THE ASSISTANT
SECRETARY FOR PANDEMIC RESPONSES
OFFICE, BARTA, THE FDA, CDC AND
USDA, TO BRIEF MEMBERS OF THE
GOP DOCTORS CONGRESS.
--SORRY GOPDOCTOR'S CAUCUS ON
WHAT WAS GOING ON WITH OUR H5 N1
RESEARCH PORTFOLIO.
THIS WAS ACTUALLY A VERY
POSITIVE INTERACTION.
YOU CAN SEE BRAD [INDISCERNIBLE]
UP THERE SITTING ACROSS THE
TABLE.
IT WAS A--I THOUGHT THAT WAS
TONE WAS VERY POSITIVE, THEY
ACTUALLY MENTIONED THAT THEY HAD
DONE THESE FREQUENTLY IN THE
BEGINNING OF THE PANDEMIC AND
PREVIOUSLY FOR OUTBREAKS AND
WOULD LIKE TO START DOING THIS
AGAIN, SO I THINK IT ACTUALLY
WAS A VERY POSITIVE INTERACTION,
I SHOULD ALSO MENTION THAT THERE
HAS BEEN A LOT OF CONGRESSIONAL
INTEREST IN OUR H5 N1 PORTFOLIO,
AND BOTH TARA [INDISCERNIBLE]
AND MIKE [INDISCERNIBLE] OF OUR
RESPIRATORY DISEASES BRANCH IN
D MID HAVE BEEN DOING SIMILAR
EFFORTS, KEEPING THEM APPRISED
AND WHAT WE'RE UP TO.
AND THEN VERY RECENTLY A VERY
SUCCESSFUL POSITIVE VISIT TO
ROCKY MOUNTAIN LABS HOSTED BY
DR. MARSHAL BLOOM LEADING A SITE
VISIT FOR CONGRESSIONAL
APPROPRIATIONS STAFF, A
BIPARTISAN GROUP FROM THE
APPROPRIATIONS SUBCOMMITTEE,
THEY HAD A TOUR OF ROCKY
MOUNTAIN LAB AND HEARD FIRST
HAND FROM INVESTIGATORS ABOUT A
BROAD RANGE OF RESEARCH, SO A
LOT OF EFFORTS TO CONTINUE TO BE
TRANSPARENT, RECEPTIVE AND TRY
TO UPDATE PEOPLE ON THE WORK
THAT WE'RE DOING IN AN EFFORT TO
CONTINUE THE POSITIVE DIALOGUE.
JUST A COUPLE OF OTHER THINGS,
I'M GOING TO DEDICATE THE
REMINDER OF THE SESSION AND I
WILL HAVE TIME FOR QUESTIONS TO
A DISCUSSION OF OTHER ITEMS THAT
I THINK ARE REALLY INTERESTING,
FOLLOW UPS, AND OTHER EXCITING
DEVELOPMENTS, JUST A WORD ON
WHAT'S BEEN HAPPENING WITH THE
HIV ARENA, WE ARE STILL NOT
WHERE WE NEED TO BE WITH HIV.
I DON'T THINK I NEED TO TELL YOU
THAT AND AT THE
IAS--INTERNATIONAL AIDS SOCIETY
MEETING IN MUNICH THIS YEAR, 1
OF THE THINGS THAT CAUGHT MY I
WAS THE FACT THAT EPIDEMICS ARE
GROWING OUTSIDE OF SUB-SAHARAN
AFRICA, IN FACT THIS WAS THE
MOST RECENT YEARTALLY WHERE THE
INCIDENTS IN THESE COUNTRIES WAS
HIGHER THAN SUB-SAHARAN AFRICA,
THE NUMBERS ARE INCREASING
THERE.
IN THE FACE OF THAT, OUR
RESOURCES FOR HIV HAVE NOT BEEN
STUDIED, THEY DROPPED BY 5% FROM
2022 AND REMAIN SHORT OF WHAT WE
NEED IN ORDER TO REALIZE WHAT
PEOPLE ARE THINKING ABOUT AS THE
2030 GOALS.
AND OF COURSE WE'RE NOT DOING
DOING
GREAT IN THE UNITED STATES.
WE'VE SEEN NICE DECLINES IN THE
ESTIMATED INCIDENTS AMONG KEY
GROUPS LIKE MALE-MALE SEXUAL
CONTACT AND ALSO GROUPS WHO WAS
INJECTION DRUGS BUT I WILL POINT
OUT THAT THE INCIDENTS IN
HETEROSEXUAL ARE ATTRIBUTABLE TO
HETEROSEXUAL CONTRACT REALLY HAS
NOT BUDGED AT ALL AND WE HAVE
NOT CONTINUED TO REACH SOME OF
THE MOST VULNERABLE POPULATIONS
PARTICULARLY IN THE SOUTHEAST.
SO WE ARE A LOT OF WORK TO DO.
THE AIDS CONFERENCE IN MUNICH,
MANY OF THE TEAM WERE THERE, I
WAS THERE, IT WAS A VERY--I
WOULD SAY POSITIVE, VIBRANT,
PRETTY INSPIRING MEETING AS
THESE MEETINGS GO, THE THEME WAS
PUT PEOPLE FIRST.
I WAS INVOLVED IN A NUMBER OF
PRESENTATIONS AS WERE MANY
PEOPLE HERE AND JUST A COUPLE OF
HIGHLIGHTS, I THINK MOST OF YOU
HAVE HEARD ABOUT LONGACKING PREP
OR PREEXPOSURE PROPHYLAXIS.
THERE WERE ORIGINAL RESEARCH
PRESENTATIONS ON THE PURPOSE
STUDY WHICH I WILL SHOW IN A
SECOND THAT INVOLVED TWICE
YEARLY INJECTION OF LENOIRA
CAPPA VIR, A CAPSID INHIBITOR,
ASSEMBLY INHIBITOR IN CIS GENDER
WOMEN WHICH WAS VERY EXCITING
OTHER AS I WILL SHOW YOU IN A
SECOND.
THERE WAS GREAT WORK FROM OUR
TEAMS SHOWING THAT INJECTABLE
[INDISCERNIBLE] WAS SAFE AND
EFFECTIVE IN PREGNANCY, WE HEARD
ABOUT THE NEXT BERLIN PATIENT
WHO HAD SUSTAINED HIV REMISSION
WITHOUT ANTIRETROVIRAL THERAPY
AS A HETEROSWROIGOUS CCR5 ALOE
GENERATED AIC STEM CELL TRAN
PLANT, LOTS OF STUFF ON
DOXYPREP, DOCKSY PEP, LOTS OF
INTERESTING INFORMATION ON
NEUTRALIZING ANTIBODIES,
PREVENTION TREME, AND CURE, AND
SUCCESS WITH GERM LINE TARGETING
WHICH HAS REALLY TAKEN OFF AND
THEN ALSO A THEME OF THE
CONFERENCE ON NEGATIVE IMPACTS
OF SIGNATURES STATE REGULATOR,
DISCRIMINATION AND
CRIMINALIZATION, IF YOU HAVEN'T
SEEN THE STUDY, LET ME SHOW YOU
THIS, IT'S QUITE GAME CHANGING
TO SAY THE LEAST.
THIS WAS A STUDY IN WOMEN IN
UGANDA AND SOUTH AFRICA, LOOKING
AT TWICE A YEAR OR EVERY 6
MONTHS INJECTION OF LENACAPP A
VIR, THE GROUP RANDOMIZED THESE
WOMEN TO EITHER THE
INVESTIGATORRAL PRODUCT OR TO
F/TAF, TENOFVIR CAP BASED
ORALLY, AND YOU CAN SEE THERE IN
THE ARM THERE, 0 INFECTIONS
OCCURRED OVER THE 1939 PERSON
YEAR FOLLOW UP, THERE WERE 16 IN
THE TDF GROUP SO SO FAR THAT
LOOKS PRETTY AMAZING.
THE DEVIL OF IS OF COURSE GOING
TO BE IN THE DETAILS.
THERE ARE A LOT OF STUDIES TO
FOLLOW UP ON THIS, AT THE SAME
TIME PEOPLE CLAMORING FOR ACCESS
JUST ON THE BASIS OF THAT FIRST
TRIAL SO, I WOULD SAY, IT'S
GIVEN THE ADVOCACY COMMUNITY
QUITE A SHOT IN THE ARM, NO PUN
INTENDED, THEY DON'T GET THIS
SHOT IN THE ARM, YOU GET IT IN
THE ABDOMEN, BUT TELL BE VERY
INTERESTING, I THINK TO SEE HOW
THIS ROLLS OUT.
WE HAVE FINGERPRINTS AND
INVESTMENT IN A COUPLE OF THE
FOLLOW UP STUDIES, PURPOSE 3 AND
4, WHICH ARE BOTH HAPPENING IN
THE UNITED STATES AS PART OF OUR
HIV PREVENTION TRIALS NETWORK,
THOSE ARE STUDIES OF THIS
PRODUCT THIS CISGENDER WOMEN IN
THE U.S. AND PEOPLE WHO INJECT
DRUG ANDS BOTH OF THOSE ARE
RECRUITING NOW.
SO VERY, VERY EXCITING TIME FOR
LONG ACTING CHEMO PREVENTION.
VERY LONG FORMS, SOME OF WHICH I
PARTICIPATE INDEED ABOUT THE
ROLE OF MONOCLONAL ANTIBODIES IN
THIS SPACE GIVEN THIS AND WHERE
THE VACCINE FIELD SHOULD BE
GOING, SO LOTS OF STUFF GOING ON
THERE.
SO JUST A WORD ABOUT STIs AS
YOU KNOW WE'RE CONTINUING TO SEE
STRATOSPHERIC INCREASES I WOULD
SAY IN BACTERIA IN PARTICULAR
STIs IN THE UNITED STATES AND
DPLOABALLY EMPLOY 1 OF THE
THINGS WE HAVE DONE TO TRY TO
ADDRESS THE SYPHILIS EPIDEMIC IS
TO SUPPORT INNOVATION IN
DIAGNOSTIC AND YOU MAY HAVE SEEN
THIS PRESS RELEASE LAST WEEK
WHICH GOT A NICE AMOUNT OF
ATTENTION.
AS YOU KNOW IT'S REALLY PAINFUL
TO DIAGNOSE SYPHILIS, IT'S
IMPOSSIBLE SOMETIMES TO TELL
WHETHER PEOPLE ARE REINFECTED
WHETHER THEY HAVE A PERSISTENT
[INDISCERNIBLE] DATE, DIAGNOSING
CONGENITAL SYPHILIS IS A REAL
MESS, SO HOPEFULLY THIS WILL GET
US TRACTION AND HELP US FIGURE
OUT HOW BET TORE GET NOT JUST TO
DIAGNOSE BUT ALSO MONITOR IN
RESPONSE TO NEW INTERVENTIONS
AND VACCINES.
WE DON'T REALLY EVEN KNOW HOW TO
MONITOR THE RESPONSE TO A
VACCINE CANDIDATE FOR
[INDISCERNIBLE].
COUPLE MORE UPINDICATES THE
SITUATION WITH H5 N1, THANKS TO
I SHOULD HAVE MENTION THAD GREG
[INDISCERNIBLE] AND BOB ISINGER
WORKED VERY HARD ON THESE SLIDES
AND UPDATED THIS SLIDE ON FRIDAY
AFTER WE HEARD THAT THERE WAS
ANOTHER CASE OF H5 N1 IN
MISSOURI.
I'M ACTUALLY QUITE NERVOUS ABOUT
THAT CASE.
I THINK THAT FROM WHAT WE KNOW
AS YOU PROBABLY HEARD IN THE
NEWS THIS CASE HAD NO NO LINK TO
EXPOSE TOWER H5 N1, IT WAS A
PERSON WITH UNDERLYING
PREDISPOSITION TO PULMONARY
INFECTION, BUT NO CONTACT TO
ANYTHING THAT COULD REMOTELY BE
LINKED BACK TO A LIKELIHOOD OF
H5 N1 EXPOSURE.
THE CDC IS ON A CALL THIS
MORNING AND IS CONTINUING TO TRY
TO SEQUENCE THE RELEVANT PARTS
OF WHAT THEY GOT.
FORTUNATELY THE CT VALUE FOR THE
ISOLATE THAT WAS RETRIEVED WAS
38 SO THEY'RE REALLY NOT GOING
TO BE ABLE TO PROBABLY ASSEMBLE
VERY MUCH OF THE GENOME, THAT
SAID IT'S ALMOST CERTAINLY
CONSISTENT WITH THE BOVINE
STRAINS.
SO IT IS NOT A MISTAKE, IT'S
REAL.
AND THERE ARE NO HERDS INFECT
WIDE H5 N1 IN MISSOURI WHICH
FURTHER CONTRIBUTES TO THE
MYSTERY.
THERE ARE GOOD THINGS, THERE'S
NO LIVE VIRUS OF COURSE, IN THE
MILK AS YOU PROBABLY HEARD AND
IT LOOKS LIKE THERE ARE RARE
GENETIC MARKERS AND RESISTANCE
TO ANTIVIRALS BUT AGAIN THIS, IS
A SITUATION THAT IS CONTINUALLY
EVOLVING.
AND THIS IS ACTUALLY THE UPDATE
THANKS TO BOB AND GREG FOR
UPDATING THAT.
IT'LL BE INTERESTING TO SEE NOW
THAT BIRDS ARE MIGRATING BACK
FROM THE ARCTIC, WHAT THEIR
SITUATION IS, IT LOOKS LIKE THE
MORETALLITY RATE IN MIGRATING
BIRDS AS PROBABLY LEVELED OFF A
BIT WHICH GIVES US SOME HOPE.
I THINK THAT THEY'RE NOT GOING
TO BE PERHAPS AS CONTAINCHIOUS,
WE DON'T REALLY KNOW, THAT WILL
DECREASE THE LIKELIHOOD OF A
PILL OVER EVENT.
WE REALLY DON'T KNOW.
WE RELEASED OUR H5 N1 INFLUENZA
AIENDA ON JUNE 5th AND I THINK
EVERYBODY HAS PROBABLY SEEN THIS
BUT I WILL SAY IT'S BEEN AN
INCREDIBLE EFFORT COORDINATING
ALL OF THOSE DIVISIONS OVER
THERE, ALL OF THOSE CENTERS,
BOTH INTRAMURAL AND EXTRAMURAL
EFFORTS.
AND JUST SOME EXAMPLES OF WHAT
OUR GROUPS HAVE PUBLISHED ARE
SHOWN HERE, DON'T HAVE TIME TO
GO INTO THEM, BUT REALLY A
FANTASTIC ARRAY OF RESEARCH
RESULTS THAT HAVE HELPED TO
INFORM THE RESPONSE AND BEEN
VERY, VERY CONTRIBUTORY.
OF COURSE WE CAN'T REST WITH H5
N1 BECAUSE MPOX HAS REALLY TAKEN
OFF, I THINK THOSE OF YOU WHO
HAVE BEEN FOLLOWING THIS WILL
KNOW, I WON'T REVIEW THE
TIMELINE BUT THIS IS A NICE
REMIND THEY'RE THESE VIRUSES
HAVE BEEN ENDEMIC IN ATRICKA FOR
A VERY LONG TIME IT JUST SEEMS
THAT BETWEEN MUTATION AND
ESCALATING HUMAN TO HUMAN
SPREAD, INCLUDING LIKELY SEXUAL
TRANSMISSION, THERE HAS REALLY
BEEN A DRAMATIC INCREASE
PARTICULARLY IN CENTRAL AFRICA
AND THE COUNTRIES THAT ARE
REALLY BEING AFFECTED ARE SHOWN
HERE.
OF COURSE THE DRC SEEMS TO BE
THE EPICENTER, SAYING THERE ARE
THOUSANDS OF CASES, THIS IS
PROBABLY AN UNDERESTIMATE BUT
THERE HAS NOW BEEN SPREAD BEYOND
THOSE BORDERS NOT SURPRISINGLY.
WE ARE ABOUT TO ACTUALLY, I
BELIEVE TODAY, IF I'M NOT
MISTAKEN RELEASE OUR MPOX
RESEARCH AGENDA.
I JUST DID A VIDEO FOR THAT ON
FRIDAY AND THAT'S A VERY, VERY
ROBUST SET OFAC IV THERAPYS, I'M
GOING TO TALK A LITTLE BIT ABOUT
THE PALM OO7 STUDY WHICH YOU MAY
HAVE HEARD ABOUT.
WE ARE LEADING THE TRIAL SPHDS
FOR RIHAVE YOU SEENS THERE AND A
NUMBER OF ACTIVITIES THERE AND
DIAGNOSTICS AND LOOKING AT A NEW
VACCINE CANDIDATE SO LOTS OF
ACTIVITY GOING ON THERE. I WANT
TO CALL OUT CLIFF WHO'S IN THE
ROOM AND HAS BEEN REALLY THE
ARCHITECT OF THIS RCT AND
[INDISCERNIBLE] OF THE DRC,
THESE RESULTS WERE RELEASED A
COUPLE WEEKS AGO, THIS WAS A
STUDY RANDOMIZING PEOPLE TO
TECOVIRIMAT, AND YOU USE IN A
MOMENT IT WAS HIGH LEVEL OF
CARE.
PEOPLE WERE ADMITTED TO THE
HOSPITAL AND PROVIDED CARE,
NUTRITION, ALL KINDS OF THINGS.
SO THE IDEA HERE WAS REALLY TO
SEE IF YOU COULD REDUCE THE TIME
TO LESION RESOLUTION AND OF
COURSE LOOK AT SECONDARY END
POINTS LIKE MORTALITY.
THESE WERE DONE IN 2 RURAL AREAS
WITH A VERY HIGH INCIDENCE OF
MPOX DISEASE, THESE ARE SOME OF
THE SITES THANK YOU TO CLIFF AND
HIS TEAM FOR PROVIDING THESE
VISUALS AND THIS HAS BEEN A
VERY, VERY LONG STANDING
PROJECT.
YOU MIGHT ALSO NOTE IT WAS
ACTIVATED IN OCTOBER 7th,
2022, SO PRETTY MUCH IN THE
HEIGHT OF THE PANDEMIC, SO
REALLY KUDOS TO THIS TEAM.
THE DISAPPOINTING RESULTS BUT
ALSO QUITE INTERESTING I THINK
WERE REAL LEESED MIDMONTH LAST
MONTH AND SHOWED THE THAT THE
DRUG WAS SAFE BUT DID NOT
IMPROVE MPOX RESOLUTION BUT WHAT
I WILL NOTE THOUGH IS THAT THE
STUDIES MORTALITY OVERALL WAS
1.7% WHICH IS DRAMATICALLY LOWER
THAN WHAT WE HAVE BEEN HEARING
IN ACCORD WITH THIS PANDEMIC
WHERE PEOPLE HAVE BEEN TALKING
ABOUT AT LEAST 3.6% AND OFTEN
HIGHER IN SOME SETTINGS, A LOT
MORE WORK TO BE DONE HERE.
CLIFF IS HERE, AND I'M SURE HE
WOULD BE HAPPY TO ANSWER
QUESTIONS BUT REALLY AN AMAZING
STUDY THAT I THINK IS GOING TO
BE VERY, VERY PIVOTAL.
NOW, I WON'T SAY MUCH ABOUT
COVID OTHER THAN, YOU KNOW YOU
CAN'T ESCAPE IT, IT KEEPS COMING
BACK, THERE'S NEW VARIANTS, YOU
KNOW THERE IS A NEW SAC SEEN
THERE'S STILL SEVERE MORBIDITY
AND ALSO MORTALITY AND THE BIG
CHALLENGE RIGHT NOW IS THE
PERSISTENT PROBLEM WITH LONG
COVID AND I WOULD ENCOURAGE YOU
TO TAKE A LACK AT THIS PAPER, IF
YOU HAVEN'T.
IT'S A GREAT REVIEW OF WHERE
WE'RE AT WITH BOTH THE POLICY,
THE MANAGEMENT AND ALSO THE
PATHOPHYSIOLOGY, IT'S REALLY
COMPLEX THERE ARE
MULTIPETRESSABLE THINGS THAT
SEEM TO BE GOING ON HERE, THERE
PROBABLY IS PERSISTENCE OF
VIRUS, THERE DEFINITELY IS
IMMUNE PERS CYST ENSEL
DISRESUTION, THERE'S DEFINITELY
T-CELL DISREGULATION, PRO
THROMBOTIC INFLAMMATION AND
MAYBE EVEN SOME DISBIOSEIS IN
THE GUT MICROBIOME THAT MAY BE
CONTRIBUTING TO BREAK DOWN OF
THE GUT BARRIER AND THE
TRANSLOCATION OF BACTERIA THAT
THEN PROVOKES SYSTEMIC
INFLAMMATION, SO IT'S A REALLY
COMPLICATED ISSUE.
WE HAVE HAD A NUMBER OF FUNDED
STUDIES ON LONG COVID
PATHOGENESIS WHICH HAVE HELPED
ILLUMINATE SOME OF THOSE
MECHANISMS THAT I JUST MENTIONED
AND THOSE ARE SHOWN HERE AND I
WILL JUST REMINDER THAT THERE
WAS A PROJECT CALLED THE COVER
THAT IS ONGOING BASED OUT OF
NHLBI WITH SOME INVOLVEMENT FROM
US, BUT WE ARE NOW ACTUALLY
STARTING A NEW PROJECT ON LONG
COVID AND NIAID CALLED RECOVER
TLC OR TREAT LONG COVID THAT IS
GOING TO BE DEDICATED TO RUNNING
CLINICAL TRIALS FOR LONG COVID
OR TO TEST AND INVESTIGATE MORE
POTENTIAL TREATMENTS, WE'RE
KICKING THIS OFF WITH A MEETING
AT THE END OF THIS MONTH AND
THIS WILL BE A VERY HIGH LEVEL
OF CLINICAL MECHANISTIC DATA,
LOTS OF COMMUNITY INPUT AS OF
LAST COUNT, BOB CORRECT ME IF
I'M WRONG, WE HAD OVER A
THOUSAND PEOPLE REGISTERED
VIRTUALLY AND WE COMPLETED THE
MAXIMUM OF IN-PERSON REGISTRANTS
OF 1 STIFF.
I WOULD SAY, MANY OF THE
LIEWMINARYS THAT YOU KNOW ABOUT
WITH LONG COVID OR FROM THE LONG
COVID FIELD ARE GOING TO BE
ATTENDING AND I THINK IT WILL BE
REALLY GOOD.
THE IDEA HERE WILL BE LOOKING AT
THE STATE OF CLINICAL TRIAL
OPPORTUNITIES, WHAT ARE THE
AGENTS WE HAVE, HOW ARE WE GOING
TO DEFINE END POINTS.
WHAT WILL WE DO TO LOOK AT
BIOMARKERS OF INTERVENTIONS, SO
IT'S A VERY, VERY GNARLY, THORNY
CHALLENGING ISSUE AND WE'RE
TAKING IT ON.
I THINK THIS MAY BE MY LAST
SCIENCE SLIDE.
I JUST CANNOT POINT OUT THIS
STUDY.
I LOVE THIS STUDY FOR A COUPLE
OF REASONS.
ONE BECAUSE IT IS JUST PUBLISHED
IN LANCET ID AND LOOKS AT THE
EFFICACY OF SPZ VACCINE WHICH
YOU MAY BE FAMILIAR WITH AND
THIS NOT ONLY SHOWED EMPRESSIVE
EFFICACY, AGAINST MALARIA, BUT
IT WAS DONE IN WOMEN WHO WERE
INTENDING TO GET PREGNANT IN THE
NEXT YEAR AND AGAIN GETTING TO
ALL THOSE STUDIES THAT WE KNOW
ABOUT THAT HAVE EXCLUDED WOMEN,
NOT ONLY IF THEY WERE PREGNANT
BUT IF THEY WEREN'T WILLING TO
TAKE HIGHLY EFFECTIVE HORMONAL
CONTRACEPTION, THIS PARADIGM
SHIFT OF ENROLLING WOMEN WHO
MIGHT GET PREGNANT AND FOLLOWING
THEM FOR WHAT HAPPENS, WILL
REALLY CHANGE THINGS FOR
REPRODUCTIVE HEALTH AND PREGNANT
CONTROL POPULATIONS IN A VERY
VULNERABLE POPULATION AND THIS
WORKED BEAUTIFULLY IN WOMEN WHO
WERE PREGNANT AND BECAME
PREGNANT DURING THE STUDY SO A
BIG KUDOS TO THE TEAM AND THEN
LAST, NOT TO LEAVE OUT THE
CRITICAL IMMUNOLOGY FINDINGS.
THIS IS ACTUALLY A VERY, VERY
IMPORTANT PAPER FROM OUR
COLLEAGUES IN DATE.
YOU MAY KNOW THAT 1 OF THE
HALLMARK OF CLINICAL SYNDROMES
OF LUPUS IS NEUROCOGNITIVE,
NEURAL INFLAMMATION
MANIFESTATIONS.
THIS IS THE FIRST IDENTIFICATION
OF A MOLECULAR BASIS FOR
COGNITIVE IMPAIRMENT, THAT IS
ACTUALLY POTENTIALLY MODIFIABLE,
THIS INVOLVES AN INTERACTION
THAT MAY BE TREATABLE WITH ACE
INHIBITORS, THAT IF YOU CAN GET
ACE INHIBITORS AND ANG CROW
TENSEIN CONVERTING INHIBITORS
ACROSS THE BLOOD BRAIN BARRIER
YOU MAY BE ABLE TO REDUCE THE
CASCADE OF INFLAMMATION THAT IS
[INDISCERNIBLE] BY THIS
INTERACTION THAT'S OF COURSE
PROMOTE BIDE DOUBLE STRAND DNA
ANTIBODIES THAT MANAGE TO GET
INTO THE BRAIN WHICH IS REALLY,
REALLY VERY, VERY INTERESTING.
SO SORRY I PROBABLY TOOK LONGER
THAN I SHOULD HAVE BUT THERE'S A
LOT GOING ON, A LOT OF REALLY
EXCITING STUFF AND WITH THAT
WOULD BE DELIGHTED TO TAKE YOUR
QUESTIONS.
I JUST WANT TO--TED, WHAT TIME
ARE YOU SUPPOSED TO COME ON, HOW
MUCH TIME DO I HAVE FOR
QUESTIONS IN 5 MINUTES IN I
DON'T HAVE THE SCHEDULE IN FRONT
OF ME.
I CAN GO ON AS LONG AS I WANT
TO, IS THAT WHAT YOU'RE TELLING
ME?
GO AHEAD.
>> YEAH, I AGREE THAT THE
LYTACAPPA VIRIS EXCITING CAN YOU
GIVE US ANY MORE DETAILS ON THE
REGULATORY PREP INJECTABLES AND
IF THERE'S ANY ROLE FOR NIAID OR
IS THIS SORT OF OUR WORK HERE
DONE SITUATION >> YEAH, SO THE
REGULATORY TIMELINE, KARL MAY
HAVE MORE INFORMATION ON THIS,
MY SENSZ SENSE IS THAT OF
COURSE, THAT WAS THEIR FIRST
PHASE 1 TRIAL SO THEY NEED TO DO
AT LEAST 2, MY SUSPICION IS THAT
AS SOON AS THAT SECOND RESULT
COMES IN, THEY WILL GO GREAT
GUNS PROBABLY ALL OVER THE
PLACE.
THE SOUTHA AFRICAN, I THINK THE
MAIN ISSUE WILL BE PRICE AND
NOW, AT THE MEETING GILLIAD WAS
VERY, I WOULD SAY PURPOSEFUL
ABOUT TALKING ABOUT SCALE UP IN
SOUTH AFRICA BEING PARTICULARLY
SOUTH AFRICA BUT SUB-SAHARAN
AFRICA, RECOGNIZING WHAT
HAPPENED WITH [INDISCERNIBLE]
WHICH IS YOU HAD A PRODUCT THAT
WAS GOOD BUT NOT AT ALL
AVAILABLE LOCALLY FOR LOTS OF
REASONS.
SO I THINK THEY HAVE BEEN VERY
PROACTIVE SO HOPEFULLY THAT WILL
HAPPEN PRETTY SOON.
KARL DID YOU WANT TO ADD
ANYTHING TO THAT?
OKAY, YOUR OTHER QUESTION
WAS--NO, REAL REALLY INVESTED
BECAUSE WE'RE ACTUALLY RUNNING
THOSE 2 TRIALS THROUGH THE
UNITED STATES, THROUGH THE HIV
PREVENTION TRIALS NETWORK SO
THEY'RE PROVIDING THE DRUG BUT
WE'RE PROVIDING THE
INFRASTRUCTURE FOR THE STUDIES,
SO I FEEL--WE FEEL PRETTY GOOD
ABOUT THAT.
VERY, VERY INVESTED.
LET'S GO TO IS THAT JAMES?
>> JIM FROM UNIVERSITY OF
WISCONSIN.
LOTS OF REALLY TERRIFIC PROGRESS
ON ANTIVIRALS AND RESEARCH IN
THAT AREA AND YOU MENTIONED THAT
BOTH THE HOUSE AND THE SENATE
HAD INCLUDED AN
80 MILLION-DOLLAR SET ASIDE, I
THINK FOR THE ANTIVIRAL
RESEARCH, SO HOW DO YOU ENVISION
THAT MOVING FORWARD WITH ALL OF
THE ONGOING ACTIVITIES?
WHAT WILL BE THE CHARGE FOR
THOSE CENTERS AND WHAT RANGE OF
ACTIVITIES WILL THEY HAVE?
>> I WILL ASK EMILY TO COMMENT
ON THAT.
I WILL SAY WE ARE AS THEY SAY
SHOVEL READY BECAUSE WE ALREADY
HAVE THE AVIDS, AND WHAT WE HAVE
TO DO WAS TRUNCATE THEIR FUNDING
DUE TO THE FUNDING CUT SO THIS
WILL SIMPLY ALLOW THEM TO
CONTINUE TO DO THE WORK THEY'RE
DOING, EMILY DO YOU WANT TO SAY
SOMETHING ABOUT WHERE THEY'RE
GOING.
>> YEAH IT WAS JUST THE SENATOR
THAT HAD THE EAR MARK, NOT THE
HOUSE EMPLOY WE DON'T KNOW WHAT
WILL HAPPEN THERE.
WE HAVE 9 FUNDED CENTERS CALLED
THE ANTIVIRAL DISCOVERY CENTERS
ALREADY AND THEY WERE FUNDED
ORIGINALLY FUNDED BY COVID,
SUMMIT LEMMAL APPROPRIATIONS
THAT CONGRESS RESCINDED SO YEAR
4 AND 5 OF THOSE WE'RE LOOKING
FOR WAYS TO CONTINUE THE MOST
PROMISING WORK WHICH IS PROBABLY
WHAT CONGRESS HAD IN MIND WHEN
THEY WROTE THAT PLAN, SO THEY'RE
ALL FOCUSED ON RNA VIRUSES,
DIRECT ACTING ANTIVIRALS
TARGETING CORONA VIRUSES AND AT
LEAST 1 OTHER RNA GROUP.
NTHANKS EMILY.
>> [INDISCERNIBLE] FROM
VANDERBILT.
SO I DON'T FOLLOW THE ACTIVITIES
TO THE U.S. HOUSE OF
REPRESENTATIVES AS CLOSELY AS I
SHOULD, BUT THE QUESTION I HAVE
IS WHAT WAS THE STATED RATIONAL
FOR DIVIDING THE NIAID BUDGET
INTO INFECTIOUS DISEASES AND
RHEUMATOLOGY?
>> IT'S A GOOD QUESTION.
I'M NOT SURE THE STATED
RATIONAL, WELL, THE STATED
RATIONAL IN MY UNDERSTANDING AND
I WOULD WELCOME OTHERS FROM THE
LEADERSHIP TEAM'S COMMENT IS
THAT IT'S SORT OF CHALLENGING
AND PERHAPS NOT THE BEST TO HAVE
SO MUCH MONEY IN 1 PLACE UNDER 1
PERSON'S CONTROL, I THINK.
IS THAT FAIR TO SAY?
CAN I SAY THAT?
JILL?
>> YEAH, I WOULD POINT OUT THAT
WAS NOT THE ONLY REORGANIZATION
OF NIH THAT WAS IN THAT REPORT
LANGUAGE AND IT IS BASED ON
HOUSE ENERGY AND COMMERCE WHITE
PAPER ABOUT RESTRUCTURING ALL OF
NETWORK IH SO THAT'S JUST 1 PART
OF A BIGGER IDEA THAT THEY HAVE,
BUT I DON'T KNOW THAT THAT
REPORT HAS MORE OF THE RATIONAL
I WOULD SAY FOR WHY THERE ARE
THOSE THINGS.
>> AND YOU KNOW THERE IS AN
OPENNESS ON THE PART OF OUR
LEADERSHIP TO TAKE THIS
SERIOUSLY, NOT NECESSARILY TO
SPLIT THINGS BUT TO REALLY LOOK
AT STRUCTURE AND FUNCTION I
MEAN, I THINK DR. BERTAGNOLLI
HAS BEEN PRETTY ENGAGED WITH
PEOPLE ON THE HILL FROM BOTH
SIDES SO I THINK THAT WILL
PROBABLY PROCEED.
THEY HAVE REINSTITUTED THE
SCIENTIFIC REVIEW BRANCH THAT,
THE GROUP I SHOULD KNOW THE NAME
OF, JILL PLEASE HELP ME.
>> SCIENTIFIC REVIEW BOARD.
>> SCIENTIFIC MANAGEMENT REVIEW
BOARD WHICH IS A GROUP OF PEOPLE
TO SORT OF MEET PERIODICALLY TO
PROVIDE MORE INPUT ABOUT OVERALL
STRUCTURE OF NIH, AND THAT HAS
NOT MET SINCE I WOULD SAY, WELL
BEFORE THE PANDEMIC, AND THAT IS
A CONGRESSALLY MANDATED GROUP, I
BELIEVE SO I THINK THERE IS AN
ATTEMPT TO BE RESPONSIVE, AGAIN,
TRANSXAIRNT TO INCREASE THE
LEVEL OF DIALOGUE ABOUT THESE
THINGS.
SOMEONE ELSE HAD--YES, PLEASE.
>> SO KUDOS TO YOUR TEAM FOR
PULLING TOGETHER SUCH A WIDE
RAINCHLING UP TO DATE
PRESENTATION EMPLOY I WANTED TO
ASK 2 QUICK QUESTIONS, SO THE
FIRST 1 I DON'T KNOW IF YOU CAN
COMMENT ON IT BUT FOR THE PERSON
WHO HAS H5 N1 IN MISSOURI, IS
THERE THINKING THIS IS A CASE OF
HUMAN-HUMAN TRANSMISSION THAT
WOULD POTENTIALLY TRIGGER ARE
OTHER ACTION?
AND THEN THE SECOND QUESTION WAS
ABOUT THE MPOX TRIAL, EXCUSE ME,
I WAS CURIOUS ABOUT THE
MORTALITY AMONG FINDINGS AND
WHETHER THAT'S A CLINICAL TRIAL
EFFECT?
OR IT'S JUST AN ISSUE OF GETTING
BETTER DATA ON MORTALITY?
>> FANTASTIC QUESTIONS, I CAN'T
TELL YOU THE H5 N1, I DO HAVE
MORE DETAILS I SOME I CAN'T
SHARE BUT I WILL SAY IF THERE
WAS SUSPICION OF HUMAN TO HUMAN
TRANSMISSION, THE THREAT LEVEL
WOULD BE ELEVATED CONSIDERABLY
SO THERE IS AT THIS TIME NO
EVIDENCE TO SUGGEST HUMAN TO
HUMAN TRANSMISSION BUT THAT IS
OF COURSE OUR WORST FEAR BECAUSE
ONCE YOU GO THERE, ALL BETS ARE
OFF SO SO FAR, NO, I CAN'T SAY
THAT, CLIFF I'M GOING TO ASK TO
YOU COMMENT ON THE TRIAL IF YOU
DON'T MIND, PLEASE?
>> OH, YEAH, I THINK IT'S LITTLE
BIT OF BOTH, WE TRIED VERY HARD
TO PUT IN STANDARDIZED
SUPPORTIVE CARE SO THE PATIENTS
HAD NUTRITION, FLUIDS,
ELECTROLYTES, A WHOLE VARIETY OF
THINGS THAT MIGHT NOT BE
AVAILABLE, I THINK THERE'S
PROBABLY A REPORTING ISSUE AS
WELL AS YOU WERE SUGGESTING THAT
WITH TIME, THOSE 2 CENTERS
BECAME KNOWN AS A PLACE TO GO IF
YOU HAD MPOX LESIONS SO WE ENDED
UP ACTUALLY HAVING FAIRLY BRISK
RECRUITMENT THROUGHOUT THE TIME
OF THE STUDY SO I THINK WE MAYBE
HAD A LARGER POPULATION THAT
MIGHT BE RECORDED IN SOME OF THE
PUBLIC HEALTH MEASURES THAT ARE
REPORTED.
>> GREAT QUESTIONS.
WE HAVE TYPE TIME FOR A COUPLE
MORE QUESTIONS, I REALIZED I
HAVE UNTIL 11:15, I'M ONLY A
MINUTE OVER AND I'M SO EXCITED
PEOPLE ARE ASKING QUESTIONS SO
PLEASE FEEL FREE TO ASK OR
COMMENT ANY FEEDBACK, ANY
THOUGHTS.
OKAY WELL IF NOT I WILL INVITE
TED PIERSON, WHO IS THE DIRECTOR
AND HEAD OF OUR VACCINE RESEARCH
CENTER.
TED, THANK YOU.
>> GOOD AFTERNOON.
IT'S A TREMENDOUS PLEASURE TO BE
HERE AND ADDRESS THE COUNCIL AND
MEMBERS OF THE COMMUNITY THAT
ARE TUNING IN.
MY CHARGE HERE TODAY IS TO TELL
YOU A BIT ABOUT THE ACTIVITIES
OF THE VACCINE RESEARCH CENTER,
ROUGHLY IN THE PAST YEAR.
I'VE STRUCTURED MY TALK INTO 3
PARTS, SORT OF HIGH LEVEL
OVERVIEW ABOUT WHAT THE VRC DOES
AND SORT OF HOW WE WORK AND
WHERE WE INVEST OUR EFFORTS, TO
GIVE YOU A SENSE OF SOME RECENT
RECRUITMENT ACTIVITIES WE WILL
SHARE A BIT ABOUT WHERE WE'RE
HEADED AND I WILL CLOSE WITH
VIGNETTES OF A FEW--MORE
DETAILED LOOK INTO THE SCIENCE
WE'VE BEEN DOING THAT'S
PARTICULARLY EXCITING.
SO THE MISSION OF THE ACSEEN
RESEARCH CENTER IS TO PERFORM
THE BASIC SCIENCE RESEARCH THAT
ENABLING THE DEVELOPMENT OF
NOVEL VACCINES AND BIOLOGICS
THAT TARGET INFECTIOUS DISEASES
OF GLOBAL HEALTH IMPORTANCE.
AND AS JEANNE MENTIONED WE HAVE
A UNIQUE STRUCTURE WITHIN THE
INTRAMURAL PROGRAM.
WE HAVE A VERY MULTIDISCIPLINARY
TEAM AND I EXPRESSED THIS IN A
LINEAR WAY, IT DOESN'T REALLY
WORK THIS WAY, BUT FOR
SIMPLICITY, WHAT THE PROCESS
START AT BUILDING 40 IN THE
BETHESDA CAMPUS WHERE WE HAVE
INVESTIGATOR LED RESEARCH
PROGRAMS THAT WORK ON
FUNDAMENTAL PROBLEMS TO ADVANCE
THE FIELD OF IMMUNOLOGY OF
IMMUNOLOGY AND VIROLOGY, SOME OF
THOSE DISCOVERIES HAVE
TRANSLATIONAL POTENTIAL AND THE
BEST OF THOSE IDEAS ARE THEN
TRANSFERRED TO THE VACCINE
PRODUCTION PROGRAM LABRATORY AND
I WOULD ABBREVIATE AS VPPSPAY
THROUGHOUT MY TALK AND THE
SCIENTISTS TAKE THOSE AND SOLVE
THE PROBLEMS THAT ARE UNIQUE TO
EACH PRODUCT CONCEPT THAT YOU
NEED TO UNDERSTAND IN ORDER TO
MANUFACTURE A PRODUCT AND THIS
IS, YOU KNOW PRETTY DIFFERENT
KINDS OF SCIENCE THAT WE DO IN
BELLING 40 AND IT'S CHALLENGING
BUT WE ARE FORTUNATE TO HAVE AN
OUTSTANDING TEAM THAT DOES THIS
EMPLOY THE OUTPUT OF THIS IS
REALLY THE INSTRUCTIONS OF HOW
TO MANUFACTURE OUR PRODUCT THAT
ARE THEN TRANSFERRED TO THE
VACCINE PILOT PLANT FOR
FREDERICK MARYLAND, THAT TEAM
MANUFACTURES THE PRODUCT AND
THEN THE PRODUCT COMES BA BEING
TO THE VRC CLINICAL TRIALS
PROGRAM, OR TIMES TO OUR
COLLABORATIVE PARTNERS WHERE WE
DO FIRST IN HUMAN CLINICAL
TRIALS.
THOSE TRIALS ARE SUPPORTED IN AN
END POINT ANALYSIS FOR THOSE
TRIALS SUPPORTED BY YET A
DIFFERENT TEAM CALLED THE
VACCINE IMUGOLOGY PROGRAM THAT
IS ALSO HOUSE INDEED
GAITHERSBURG THAT DOES THAT
WORK.
SO VRC WAS FOUNDED TO SOLVE THE
PROBLEMS THAT WOULD ENABLE THE
DEVELOPMENT VACCINES FOR HIV.
AND I WOULD SAN FRANCISCO I THAT
THE VRC MADE TREMENDOUS PROGRESS
IN THIS AREA IN THE LAST 20
YEARS AND 1 OF THESE IS REALLY
THE DEVELOPMENT OF THE CONCEPT
OF STRUCTURE GUIDED VACCINE
DECIDE.
THIS WAS PIONEERED BY PETER
QUANG AND COLLEAGUES, AND THE
WAY THIS WORKS IS THAT THE TEAM
WILL SOLVE STRUCTURES OF OVERALL
PATHOGEN THAT ARE CRITICAL TO
ITS BIOLOGY SUCH AS THE ABILITY
OF THE VIRUS TO ENTER CELLS AND
ON THE TOP LEFT THERE, YOU'RE
SEEING THE STRUCTURE OF THE
GP120 PROTEIN THAT IS ON THE
EXTERIOR OF HIV ENTER CELLS.
WE THEN USE THIS INFORMATION TO
IDENTIFY B-CELLS THAT ARE
ILLICITTED BY INFECTION OR
VACCINATION IN HUMANS OR
RELEVANT ANIMAL MODELS TO
UNDERSTAND WHAT THE IMMUNE
SYSTEM TELLS YOU ABOUT
ANTIBODIES THAT HAVE DESIRABLE
FEATURES WHEN YOU MARY THESE 2
THINGS TOGETHER, YOU GET THE
INTERESTING CONCEPT THAT THE
IMMUNE SYSTEM IS TELLING WHAT
ARE THE IMPORTANT ANTIBODIES
THEY CAN TELL YOU HO HOW TO
STABILIZE OR PRESENT THOSE
EPITOPES THAT COULD BE IN A WAY
FOR ANTIIEN VACCINE DEVELOPMENT
AND THE BOTTOM LEFT IS AN
ANTIBODY CALLED VRC MOLECULE 1
WHICH IS FOUND DOWN TO THE
CONSERVED BINDING SITE ON GP120.
SO THE PORTFOLIO HAS EXPANDED
CONSIDERABLY SINCE ITS
INCEPTION, WHAT I DEPICTED HERE
THAT I LISTED ARE VIRUSES THAT
HAVE STRUCTURAL VIRUSES IN
COMMON WITH HIV.
THE TYPE OF PROJECTS WE DO IN
THOSE SPACES OR IN THOSE BLUE
BOXES AND RED TEXT IS ANYWHERE
THAT OUR PROCESS DEVELOPMENT
TEAM, THE VPP IS DOING PROCESS
DEVELOPMENT OR THE CLINICAL
TRIALS PROGRAM IS PREPARING FOR
OR CONDUCTING CLINICAL TRIALS
AND ALL OF THE SCIENCE REALLY
LEVERAGES THE SAME STRUCTURE
GUIDED PRINCIPLES THAT WERE
DEVELOPED WITH HIV AND REALLY
TERRIFIC EXAMPLE IS THE WORK
THAT WAS DONE TO STABILIZE THE
ENTRY, VIRAL ENTRY OF RSV TO
MAKE THE STABILIZED DSK 1 AND
THAT IS IN THE GSK RSV VACCINE,
BUT THERE ARE MANY OTHER
EXAMPLES INCLUDING THE
TREMENDOUS WORK THAT WAS DONE BY
GRAHAM'S TEAM TO STABILIZE THE
SPIKE CORONA VIRUSES, OUR INFLU
EANS AND NANO PARTICLE VACCINE
PROGRAM LED BY [INDISCERNIBLE]
AND ANTIBODY DISCOVERY PROGRAMS
ACROSS THIS PORTFOLIO TO INCLUDE
HIV, INFLUENZA, CORONA VIRUSES
AND MALARIA.
ONE CURRENT EXAMPLE OF THE
APPLICATION OF THIS IS OUR
INTEREST IN DEVELOPING A VACCINE
FOR A VIRUS CALLED MEPA VIRUS
AND SHOWN ON THE LEFT IS A
REALLY INTERESTING STRUCTURE
GUIDING THE DESIGN OF 2 ANTIGENS
FROM NIP A H, AND IN THE END, IN
THIS NOVEL VACCINE IS NOW IN THE
CLINIC BEING EXPRESSED BY THE
MODERNA WORK, THE SCIENTIFIC
DATA LOOKS TO BE EXCITING AND
THE CLINICAL DATA LOOKS TO BE
PROMISING AND I'M LOOKING
FORWARD TO SHARING THOSE DATA
WHICH THEY BECOME AVAILABLE.
BUT NOT ALL THE VIRUSES WE STUDY
HAVE THOSE STRUCTURAL FEATURES
IN COMMON WITH HIV.
THERE ARE MANY VIRUSES THAT HAVE
A DIFFERENT WAY OF DOING THINGS
AND FLAVI VIRUSES AND
[INDISCERNIBLE] ARE VIRUSES
TRANSMITTED THROUGH ARTHROPOD
VECTORS THAT DO THEIR BUSINESS
WITH A REALLY DIFFERENT AND
STRUCTURAL AND FUNCTIONAL
DENATIONAL LIBRARY OF
MEDICINEETRY, THE VRC HAS A
CONSIDERABLY INVERMEN INFECTED
VEF VESTMENT IN THESE VIRUSES IN
SEVERAL YEARS, HAVING DONE 8
CLINICAL TRIALS FOR VIRUSES THAT
HAVE THESE TRANSFUSION PROTEINS
1 OF WHICH THAT'S NOTABLE IS THE
DEVELOPMENT OF A CHICKEN GUNNIA
VACCINE WHICH IS THE VACCINE
CONCEPT THAT IS THE BAVARIAN
NORDIC VACCINE WHICH IS AWAITING
APPROVAL BY THE FDA AND THE
[INDISCERNIBLE].
WE CURRENTLY RUN A DISCOVERY
PROGRAM FOR VIRUSES WITHIN ALL 3
OF THESE GROUPS INCLUDING
EFFORTS TO IDENTIFY GENERAL
SOLUTIONS FOR ANTIGEN DESIGN
SUPPORTED BY ANTIBODY DISCOVERY
FOR VIRUSES THAT INCLUDE WEST
NILE VIRUSES, ZIKA AND EMERGING
GROUP OF VIRUSES INCLUDING
VIRUSES INCLUDE THANKSGIVING
VIRUS THAT SHE MAY HAVE BEEN
READING ABOUT IN THE NEWS, THAT
IS CURRENTLY BEING INVESTIGATED
BY OUR TEAMS, INDIVIDUALS SHOWN
ARE A PORTION OF MY TEAM THAT'S
WORKING ON THESE VIRUS PROBLEMS.
AND THEN FINALLY NOT ALL OF THE
VIRUSES WE STUDY EVENT HAVE
VIRAL ENVELOPES THAT ARE
EMBEDDED WITH THE MEMBRANES, WE
STUDY VIRUSES THAT HAVE NO
MEMBRANE AT ALL AND THESE
NONPROFESSIONAL VIRUSES PRESENT
A UNIQUE SET OF CHALLENGES AND
WE'VE BEEN MAKING PROGRESS IN
SEVERAL AREAS.
FIRST AND NOTABLY WE HAVE
DEVELOPED A VACCINE, VIRUS LIKE
PARTICLE FOR AN ENTHUSIASM ROUGH
ATOM VIRUS CALLED EDB68 AND THE
VPP CURRENTLY IS TRYING TO SOLVE
THE PROBLEMS OF LEARNING HOW TO
PRODUCE AND PURIFY A VACCINE
ANTIGEN INTRACELLULARLY.
DURING THE PAST YEAR, THOUGH, WE
CONTINUED TO WORK ON THIS
PROGRAM AND HAVE SOLVED
STRUCTURES OF THOSE VLPs AND
DISCOVERED ANTIABOUTS THAT ARE
PROTECTED IN VIVO.
WE'VE ALSO IN THE LAST YEAR,
MARIO WIDE WHAT TEAM HAS
DEVELOPED THE FIRST NONHUMAN
PRIMATE MODEL FOR NORO VIRUSES,
THIS IS REAL LE EXCITING BECAUSE
IT WILL,A LOW US TO USE THIS
MPh MODEL TO TEST THIS FOR
NORA VIRUSES AND ANTIBODIES THAT
CAN PROTECT AGAINST PROTECTION
AND WE ALREADY HAVE SIGNIFICANT
PROGRESS IN BOTH OF THOSE AREAS.
SO I'VE TOLD YOU ABOUT A LOT OF
VIROLOGY, BUT WE DON'T JUST DO
VIROLOGY AT THE VRC, BUT WE ALSO
WORK ON TB, AND VACCINE
DWEMMENT. -
D
E
VELOPMENT.
I WILL TELL YOU ABOUT OUR
SIGNIFICANT PROGRESS ON MALARIA
AT THE END OF OUR TALK.
THE STAFF ARE IMMUNOLOGIST AND
VIROLOGISTS THAT WORK ON
FUNDAMENTAL CONCEPTS AND
DISCIPLINES AND SOME OF THE
IMMUNOLOGY WE DO HAS
APPLICATIONS IN CANCER AND THEN
FINALLY THE TEAM AT THE VRC IS I
THINK QUITE INNOVATIVE AND
LOOKING FOR OPPORTUNITIES TO
DISCOVER WAYS OF DOING THINGS
DIFFERENTLY AND 1 I THINK REALLY
DISRUPTIVE TECHNOLOGY THAT HAS
BEEN DEVELOPED BY DANNY DEW'S
TEAM IN THE LAST FEW YEARS IS
THE ABILITY TO REALLY ACCELERATE
ANTIBODY DISCOVERY.
THEY DEVELOPED A TECHNIQUE
CALLED RAPID ASSEMLY TRANSVEKS
PRODUCTION IT'S CALL AN ACRONYM
CALLED RAT PIG AND IT ALLOWS YOU
TO QUICKLY CLONE EXPRESS AND
TEST ANTIBODIES FROM SINGLE
B-CELLS THAT YOU SORT FROM
HUMANS OR ANIMAL MODELS.
AND HENRY AT THE VRC RUNS A CORE
TEAM THAT DOES THESE TESTS ON
MORE THAN A THOUSAND ANTIBODIES
PER WEEK NOW AT THE VRELIGIOUS
C.
THE PREPIS DEVELOPED BY DANNY
AND NOW LET LED BY ALLYSON
SPALLING IS LEVERAGING THIS
CAPABILITY IN A NETWORK OF MORE
THAN 2 DOZEN COLLABORATIONS TO
DISCOVER ANTIBODIES FOR VIRAL
PATHOGENS THAT ARE EITHER GLOBAL
OR REGIONAL PROBLEMS, THESE
COLLABORATIONS NOT ONLY INVOLVE
SCIENCE BUT TECHNOLOGY TRANSFER
AND TRAINING.
SO THAT IS THE WHIRL WIND HIGH
LEVEL SORT OF GLIMPSE AT THE
PORTFOLIO.
SO SINCE I WAS APPOINTED
DIRECTOR WE'VE REALLY BEEN
SPENDING A LOT OF TIME THINKING
ABOUT THE FUTURE AND RECRUITING
NEW FACULTY AND SCIENTIFIC
LEADERS TO THE VRC.
DURING THE PAST YEAR, WE HAVE
BEEN WORKING TOWARDS RECRUITMENT
OF FACULTY REALLY WITH A 2 PRONG
STRATEGY, FIRST BOTH SUPPORTED
BY AN INTERNATIONAL SEARCH TOOL
WITH A BROAD AND DIVERSE
APPLICANT POOL.
TODAY I WILL TELL YOU ABOUT OUR
RECRUITING AND SUCCESS FOR
RECRUITING AND TRAINING 3
SCIENTISTS THAT STRENGTHENED OUR
INFLUENZA AND HIV PROGRAMS.
WE ALSO ARE--HAVE AN EQUAL
OPPORTUNITY TO IDENTIFY 3
ADDITIONAL NEW COLLEAGUES THAT
WILL BRING NEW SCIENCE AND NEW
PERSPECTIVES TO THE VRC AND
THOSE RECRUITMENT ACTIVITIES ARE
ONGOING.
SO I WILL INTRODUCE YOU TO THEM.
THE FIRST IS DR. NICOLE ROSE,
SHE WAS RECRUITED TO THE
FACULTY, SHE WILL TEAB OR HAS
JUST ESTABLISHED THE ANTIBODY
IMMUNITY SECTION AND NICOLE IS A
NATIONALLY RECOGNIZED LEADER IN
THE ROLE OF HIV ANTIBODIES.
SHE PLAYED A KEY ROLE IN THE
DISCOVERY OF AN ANTIBODY CALLED
CAP 256 AND IN COLLAB WITH OUR
COLLEAGUES FOR THE CENTER OF
AIDS RESEARCH PROGRAM IN SOUTH
AFRICA, CAPRISA, AND I WILL TALK
MORE ABOUT CAP 256 IN MY TALK IN
A FEW SLIDES.
HE'S ALSO DONE A LOT OF WORK TO
UNDERSTAND HOW THIS PARTICULAR
ANTIBODY WHICH HAS REALLY
INTERESTING FEATURES EVOLVED
SLOWLY OVER THE COURSE OF HIV
INFECTION.
AND THEN SHE WAS REALLY
SUPPORTIVE THROUGH THESE STUDIES
BY DOING ENABLING NEUTRALIZING
ANTIBODY TESTS IN HER LABORATORY
THAT PROVIED THE DATA THAT
SUPPORTED APPROVAL FOR THE
BOOSTING AND THE BOOSTERS.
SO IN OUR OWN INDEPENDENT LAB,
NICOLE WILL STRENGTHEN OUR
PROGRAM TO DISCOVERY AND
STRUCTURE GUIDED VACCINE
DEVELOPMENT AND IN THE VACCINE
SPACE SHE'S INTERESTED IN
LEARNING TO HOW TO ILLICIT
ANTIBODIES FOR THIS EPITOPE, I
WILL SHOW YOU, RECOGNIZED BY
THAT CAP 256 ANTIBODY.
SHE'S ALSO INTERESTED IN TRYING
TO UNDERSTAND STRATEGIES TO
ILLICIT ANTIBODIES TO UNIQUE
MEMBRANE PROXIMAL EPITOPE THAT
EXISTSA THE ISHT FACE BETWEEN
THE VIRAL PROTEIN CONTACTS THE
VIRAL MEMBRANE.
NEXT, I'M REALLY PRIVILEGED TO
HAVE RETAINED SARAH ANDREWS AT
THE VRC, IS A TENURED TRACK
FACULTY AND HAS LAWRCHED THE
B-CELL IMMUNOLOGY SECTION THIS
PAST SUMMER.
PRIOR TO THIS APPOINTMENT SHE
LED THE VACCINE AND MONITORING
CONSORTIUM THAT WAS BEEN THE
COLLABORATION FOR AIDS
VACCINATION OR STOEVERY WITH
CRBD WITH THIS AND THIS FTION
THE TEAM THAT PROVIDED CUTTING
EDGE B-CELL PHENOTYPING AND
SUPPORT OF NIAID NETWORKS
SUPPORTED CLINICAL TRIALS.
SARAH ALSO RAN A SEPARATE
RESEARCH TEAM FOCUSED ON
INFLUENZA IMMUNOLOGY, AND SHE
REALLY IS A LEADER IN THE FIELD,
OF IMIEWNLOLOGY INFLUENZA TRYING
TO FOCUS ON UNDERSTANDING THE
IMMUNE SYSTEM ILLIAISONIS THE A
RESPONSE TO NEW INFLUENZA TRAINS
AGAINST A BACK DROP OF AN IMMUNE
SYSTEM THAT IS REALLY PRIMED TO
RECOGNIZE THE STRAINS THEY HAD
SEEN IN PRIOR YEARS.
AS AN INDEPENDENT PI WILL SHE
TRY TO UNDERSTAND THE MECHANISM
OF THIS PHENOMENA CALLED
IMPRINTING, SHE WILL EXPLORE THE
IMMUNO DOMINANTS OF ANTIBODY
REPERER TWOARS AND WHAT KIND OF
EPITOPES ARE RECOGNIZED BY THE
IMMUNE SYSTEMS AND POPULATION
THROUGH THE STUDIES AND CLINICAL
VACCINES AND SHE WILL REALLY
CONTINUE TO BE A THOUGHT LEADER
AT THE VRC AND DEVELOPMENT OF
INFLUENZA RACK SEENS THAT
ILLICIT ANTIBODIES THAT CONSERVE
FEATURES FOR BOTH SEASONAL
STRAINS AND THOSE WITH PANDEMIC
POTENTIAL.
LASTLY BUT NOT LEAST, TOM
[INDISCERNIBLE] HAS AGREED TO
JOIN THE VRC FACULTY, HE
LAUNCHED THE STRUCTURAL BIOLOGY
AND VACCINOLOGY THIS SUMMER.
BEFORE THIS APPOINTMENT HE LED
THE STRUCTURAL BIOLOGY
INFORMATICS CORE.
HE REALLY TEABED THIS CUTTING
EDGE STRUCTURAL BIOLOGY THAT IS
THE PLATFORM UPON WHICH MANY OF
THE VRC SUCCESSES REST.
SPECIFICALLY AS AN HIV
INVESTIGATOR, HE AND PETER
ESTABLISHED THE BINDING SITE AS
A CONSERVED TARGET FOR VACCINE
DESIGN THROUGH THE STRUCTURAL
CHARACTERIZATION OF THE ANTIBODY
THAT BINDS THAT CD4 BINDING SITE
ANALYSIS STRUCTURE I SHOWED YOU
ON SLIDE 3.
TONG QING ALSO TEABED A
VULNERABLE ON THE VIRUS THAT
COULD PLAY PART IN THE
VACCINATION, AND HE PLAYED KEY
ROLES OF DISCOVERY STRUCTURES
FOR SARS-COV-2 AND COVID, AS AN
PI, HE WILL CONTINUE TO
ADADVANCE OUR PROGRAM ON HIV
THROUGH STUDIES OF THE
STRUCTURE, THE VIRUS, STRUCTURE,
VIRUS AND COMPLEX OF ANTIBODY
AND THROUGH ANTIGEN DESIGN
TARGETING ANTIBODIES AGAINST THE
CD4 BINDING SITE.
THROUGH THESE PROGRAMS HE WILL
IMPLEMENT OR INTEGRATE, I SHOULD
SAY INTO OUR PIPELINES THE USE
OF AI WHICH I THINK WILL BE
TRANSFORMATIONAL.
HIS INTERESTS HAVE EXPANDED WITH
THE VRC, YOU SAW STRAWCTURES OF
MANY VIRUSES OUTSIDE OF HIS HIV
ROOTS, HE PLANS TO CONTINUE TO
DO SO, INCLUDING THE STUDY OF
THE STRUCTURAL FEATURES OF
VIRUSES THAT ARE NOT CURRENTLY
INCLUDED IN THE VRC PORTFOLIO
SUCH AS HTLV1.
SO I THINK--I KNOW WE ARE REALLY
EXCITED AND FORTUNATE TO HAVE
RETAINED 3 INVESTIGATORS, 3
HIGHLY SOUGHT AFTER
INVESTIGATORSA THE VRC THAT
REALLY STABILIZE AND EXTEND OUR
EFFORTS TO SOLVE THE IMPORTANT
PROBLEMS REQUIRED TO BRING
COUNTERMEASURES FOR HIV AND
INFLUENZA TO REALITY, BUT WE
REMAIN COMMITTED TO EXTENDING
THE WAY WE THINK ABOUT
PROBLEMMINGS BY BRINGING NEW
COLLEAGUES TO THE VRC THAT THINK
ABOUT THINGS IN NEW WAYS OR
INTERESTED IN NEW PROBLEMS TO
SOLVE, PARTICULARLY THOSE CROSS
CUTTING ASPECTS OF VIROLOGY AND
IMMUNOLOGY THAT CAN TOUCH UPON
AND INFORM OUR ENTIRE PORTFOLIO.
SO WE'RE LAUNCHING OUR ADD IN A
COUPLE OF MONTHS, I ENCOURAGE
YOU TO LOOK OUT FOR THAT AND WE
CERTAINLY WOULD LIKE TO HEAR
FROM ANYONE INTERESTED IN THE
TYPE OF WORK WE DO THAT IS
PROPERLY QUALIFIED.
AND SO IN ADDITION TO FACULTY, I
WOULD LIKE TO INTRODUCE TO THIS
TEAM DR. JASON GALL.
JASON, WE SUCCESSFULLY RECRUITED
AND JUST ONBOARDED SHORTLY AGO
AS THE CHIEF OF THE VACCINE
PRODUCTION PROGRAM AT THE VRC.
JASON WILL IN THAT ROLE WILL
ALSO WORK CLOSELY WITH ME AS THE
DIRECTOR OF STRATEGIC PLANNING
AND DEVELOPMENT, JASON IS A I
HAVOLOGYIST WHO HAS WORK INDEED
HIV SPACE THAT HAS CONSIDERABLY
EXPERIENCE AND BIOMEDICAL
PRODUCT DEVELOPMENT.
HE'S LED THE DEVELOPMENT AND
MANUFACTURING AND EVALUATION FOR
MORE THAN 25 BIOLOGICALS.
PRIOR TO THIS RECENT
APPOINTMENT, HE SERVED AS THE
SCIENTIFIC PROGRAM MANAGER OF
THE VPP AND IN THAT ROLE HIS
LEADERSHIP WAS REALLY
TRANSFORMATIVE THROUGH THE
IMPLEMENTATION AND OPTIMIZATION
OF THE SORT OF UNIQUE HANDSHAKE
REQUIRED TO TAKE THOSE
DISCOVERIES OUT OF BUILDING 40,
DISCOVERED BY BASIC SCIENTISTS
AND TRANSFER THEM INTO THIS
REALLY DIFFERENT ECOSYSTEM OF
PROCESS DEVELOPMENT AND REALLY
JASON HAS EXPERTISE IN BOTH OF
THOSE AREAS AND HAS REALLY
UNIQUELY QUALIFIED TO DO THAT
AND I AM JUST THRILLED WE WERE
ABLE TO RETAIN HIM AT THE VRC IN
THIS NEW ROLE AND REALLY WELCOME
HIM TO THE SENIOR LEADERSHIP
TEAM OF THE VRC.
ALL RIGHT, SO IN THE REMAINING
TIME I HAVE, I WANTED TO JUST
TELL YOU A LITTLE BIT MORE ABOUT
JUST 4 VIGNETTES OF PLACES WE
ARE WORKING SPECIFICALLY WITHIN
THE PORTFOLIO.
AND THE FIRST IS I WANT TO COME
BACK TO HIV AND THIS ANTIBODY
CAP 256, SO CAP 2 PIXELS AS--CAP
256 IS AN ANTIBODY RECENTLY
DISCOVERED BY THE TEAM FROM
CAPRISA, IT'S AN ANTIBODY THAT
IS HIGHLY MUTATED AND IT'S HEAVY
AND LIGHT CHAINS COMPARED TO THE
GERM LINE SEQUENCES AND IT
EVOLVED OVER A LONG PERIOD OF
TIME IN A PERSON LIVING WITH
HIV.
ONE INTERESTING FEATURE OF THIS
ASPECT BODY IS THAT ON THE HEAVY
CHAIN, CAN YOU SEE THIS FINGER
THAT STICKS UP IN YELLOW THERE,
QUITE PROMINENTLY OFF THE
SURFACE OF THE ASPECT BODY
MOLECULE CAN THIS IS THE FEATURE
THAT THE ANTIBODY EVOLVED TO
REACH PAST THE GLYCANS THAT HIV
HAS THAT COVERS THE GP120 AND
CONTACT THE EPITOPE ON THE V1,
V2 APEX SHOWN THERE IN BLUE ON
TOP OF THE MOLECULE.
THIS EABT BODY IS POTENT, IT
NEUTRALIZES HIV AT LOW
CONCENTRATIONS, THE PROBLEM IS
IT IS NOT VERY BROAD, MEANING IT
DOESN'T HAVE THE ABILITY TO BIND
TO AND NEUTRALIZE DIVERSE
STRENGTHS.
NONETHELESS TO UNDERSTAND THE
BIOLOGY OF THIS ANTIBODY,
FURTHER, THE VR CONSIDER
MANUFACTURED THIS ANTIBODY AND
TESTED AND IN FIRST IN HUMAN
CLINICAL TRIALS AT OUR SITE AT
THE CTP AND IN COLLABORATION
WITH OUR COLLEAGUES AT
CAPRISA IN SOUTH AFRICA.
BUT I MENTIONED THE ANTIBODY HAS
THIS LIMITATION AND THAT'S NOT
WROUGHT.
SO THE WAY TO ADDRESS THAT
PROBLEM, WE HAVE EXPLORED
BUILDING A MOLECULE THAT IS
CALLED A BI-SPECIFIC, TAKES A
NEW ANTIBODY AND ADDS A NEW
FUNCTIONALITY AND ON THE LEFT
YOU CAN SEE THE NEW
FUNCTIONALITY IS THE ORANGE
CIRCLE, THIS IS A NANO BODY FROM
A LLAMA, LLAMAS MAKE NANO BODIES
THAT HAVE MANY OF THE FEATURES
THAT HAVE ANTIBODIES LIKE HUMANS
AND THEY CAN BIND TO THINGS BUT
THEY DO SO IN A VERY SMALL
PACKAGE.
SO THIS LLAMA ANTIBODY CALLED Y3
IS SPECIFIC FOR THAT CONSERVED
CD4 BINDING SITE.
SO IN THE MIDDLE, YOU CAN SEE
THE HEAVY AND LIGHT CHAINS OF
CAP 256 BOUND TO THAT APEX
EPITOPE.
THERE'S A YELLOW ANCHOR IS IN
RED THAT'S WHERE J3 IS STICKING
INTO THE CD4 BINDING SO SO THIS
NOW TAKES IT POTENT AND MAKE ITS
BROAD BY ADDING A
CONTRIBUTALLITY THAT CONTRIBUTES
IT.
AND OF COURSE THE COMPONENTS OF
THE ANTIBODY ARE BETTER THAN
WHAT ARRIVED, THIS CAN NOW
NEUTRALIZE 97% OF THE VIRUSES IN
A PANEL OF 2 HAD 08 VIRUSES FROM
AIDS AND HIV FROM ACROSS THE
FLOAB.
SO MOVING FORWARD WE ARE PUSHING
THIS NOVEL ANTIBODY INTO THE
CLINIC AFTER ITS BEEN
MANUFACTURED BY THE VPP, CAP 256
WAS A REALLY HARD ANTIBODY TO
MANUFACTURE, REQUIRED SOLVING A
LOT OF PROBLEMS AND JASON'S TEAM
LEVERAGED THOSE ON THE WAY TO
SUCCESSFULLY MAKING CAP J3.
IN THE TRIAL WE WILL EVALUATE
THE SAFETY OF THIS ANTIBODY
FORMAT THAT INCLUDE THIS IS
ANTIBODY FROM LLAMA.
WE WILL EXPLORE THE PK OF THIS
INTERESTING ANTIBODY FORMAT, AND
THE DEVELOPMENT OF ANTIDRUG
ANTIBODIES THAT WILL LIMIT THIS
AND IT'S PK AND FINALLY WE WILL
EVALUATE THE SPECIFICACKIVITY OF
THE MONOCLONAL TERMS OF BREDTH
AND POTENCY IN VIVO AND THIS
WILL BE IN A TRIAL WITH JOE
KAZAZA, WITH THE VRC AND THE PI,
AND THE CLINICAL TRIALS PROGRAM
M
O
V
I
N
G
T
O
HIV VACCINES THIS IS A
SCHEMATIC THAT DESCRIBES THIS
LINEAGE CONCEPT THAT JEANNE
MENTIONED AND BRINGS IN THE
CONCEPT OF OW ANTIBODIES ARE
USEFUL IN WILLING YOU ABOUT
SITES OF VULNERABILITY, SO ON
THE LEFT IT DRIEBS WHAT I HEARD
TOLD YOU THAT ANTIBODIES CAN
TELL YOU WHERE YOU MIGHT WANT TO
TARGET THE IMMUNE RESPONSE, ON
THE RIGHT IT DRIEBS THIS LINEAGE
DEVELOPMENT OF MATURATION AND
THAT IS A PROCESS BY WHICH YOU
IMMUNIZE WITH ANTIGENS DESIGNED
TO STIMULATE THE GERM LINE OF AN
ANTIBODY, AND IN A VERY DIRECTED
WAY, MATURE AND GUIDE THE
DEVELOPMENT OF THOSE ANTIBODIES
THROUGH SUCCESS OF IMMUNIZATIONS
WITH DIFFERENT BUT RELATED
ANTIGENS THAT THE IDEA IS TO
LEAD THE ANTIBODY PATH WHERE YOU
NEED IT TO GO EMPLOY YOU ONLY
COULD DO THIS IF YOU KNOW WHAT
THE SORT OF ONTOGNY OF THE
ANTIYOU'RE ABOUTED IN LOOKS
LIKE, BECAUSE THE ANTIGENS THAT
ARE ON YOUR LAST IMMUNIZATION
SOMETIMES ARE NOT EVEN BOUND BY
THE B-CELLS THAT STARTED THIS
PROCESS.
SO THE KEY THING IS YOU HAVE TO
HAVE THE ANTIBODY THAT IS THE
SITE OF VULNERABILITY, FOR THE
VRC, WE ARE WORKING ON A PROGRAM
WORKING TOWARDS A CONFUSION
PEPTIDE THAT IS INTEGRAL TO THE
WAY THE VIRUS WORKS AS A SITE OF
VULNERABILITY, WHY IN BECAUSE WE
HAVE IEE, AUDIENCE DEBTIFIED
ANTIBODIES THAT BIND THIS SIDE
OF VULNERABILITY AND ON THE LEFT
YOU CAN SEE AN ANTIBODY CALLED
VRC 34 THAT BOINDS INTO CANCER
CENTER ANGLE GP120 TO BIND THRA
SITE.
DURING THE PAST YEAR IN A
TERRIFIC PAPER BY
[INDISCERNIBLE] AND COLLEAGUES,
THEY DEMONSTRATE THAD ANTIBODIES
LIKE THIS IF ADMINISTERED
PASSIVELY CAN PROTECT FROM
MUCOSAL CHALLENGE BY SIV.
SO WE KNOW THAT KIND OF
ANTIBODIES CAN BE PROTECTED
EMPLOY WE ALSO KNOW YOU CAN
ILLICIT THESE KIND OF ANTIBODIES
ALBEIT EFFICIENTLY WITH THE
KINDS OF HIV TRIEMERS THAT ARE
ALREADY BEING TESTED IN CLINICAL
TRIALS SUCH AS THAT WE REALLY
NEED A STRATEGY TO MAKE
ILLICITTING THESE ANTIBODIES
MORE EFFICIENT AND THIS IS THE
IDEA THAT THE VRC HAS BEEN
WORKING ON FOR QUITE SOMETIME
STARTING WITH WORK DONE BY PETER
QUONG AND PETER [INDISCERNIBLE].
THE IDEA IS TO TAKE THE FUSION
PEPTIDE ITSELF IS CONJUGATE IT
TO SOMETHING, IN THIS CASE THE
HEAVY CHAIN OF TETANUS TOXOID TO
MAKE ANTIBODIES AGAINST THE
FUSION PEPTIDE.
SO YOU PRIME, BOOST, AND THEN
EVENTUALLY YOU CAN AM IN WITH A
TRIEMER THAT POSITIONS THE
FUSION PEPTIDE IN A BETTER
CONTEXT TO MATURE AND POLISH
THOSE ANTIBODY RESPONSES.
SO THIS IS OUR APPROACH, WE HAVE
DISCOVERED AND MORED MULTILE
TIMERS, WE'RE TESTING DIFFERENT
LENGTHS OF THAT FUSION PEPTIDE O
TIDE BUT WE ARE PLANNING AND
IMEERING UP TO DO A CLINICAL
TRIAL AND THE PRIME AND
ANTIBODIES THIS TRIAL WILL BE TO
ESTABLISH THE SAFETY OF THIS
APPROACH BUT ALSO PROVIDE AN
APPROACH TO LOOK IMMUNOLOGY TO
DEVELOP THE APPROPRIATE LINEAGE
OF THESE CELLS AS SUGGESTED BY
THE WORK IN CLINICAL STUDIES.
IN ADDITION WE HAVE AN ARK
DITIONAL HIV CLINICAL TRIAL
CALLED VRC21, OF AN TRIEMER THAT
IS ENGINEERED TO MASK THE IMMUNO
DOMINANT BASE OF THE TRIEMER SO
THIS IS THE EXAMPLE YOU DESIGN
SOMETHING ELSE AND PULL BACK IN
AND HAVE A CLINICAL TRIAL IF YOU
TAKE IT OUT, YOU EXPOSE
SOMETHING THAT'S NOT SEEN MORE
AND THE SYSTEM MAKES ANTIBODIES
TARGETED AGAINST SOMETHING
YOU'RE NOT INTERESTED AND THAT'S
THE BASE, WE HAVE 1 IDEA TO
ESTABLISH THE SAFETY OF MOLECULE
THAT CAN BE INTEGRATED INTO THE
PRIME BOOST STRATEGIES SO THAT
IS THE MAIN FOCUS OF OUR
STRATEGIES AND WE REMAIN
DEDICATED TO PREVENTIONS OF HIV.
MOVING TO OUR FLU FRESHMAN, I
WANT TO SHARE A PAPER THAT
[INDISCERNIBLE] TEAM PUBLISHED
IN IMMUNITY AND IT DESCRIBES AN
AMAZING ANTIBODY.
SO ON THE LEFT IS A CARTOON OF
FLU, AND INFLUENZA VIRUSES ARE
STUDDED WITH 2 PROTEINS, THE
FIRST IS THE HEMODPLIEWTIN
PROTEIN THAT'S PRIMERS OF HA,
AND HA IS THE PROTEIN THAT
DRIVES THE ENTRY OF FLU INTO
CELLS.
HA IS THE TARGET OF A LOT OF
NEUTRALIZING ANTIBODIES THAT
EITHER BIND THE LESS CONSERVED
HEAD OR VERY CONSERVED STEM AND
THE VRC HAS MULTIPLE VACCINE
PROGRAM TREATMENT OF SUBSTANCE
ABUSE ILLICIT ANTIBODIES TO
TARGET THE HEAD OR THE STEM THAT
ARE LED BY MASARU AND SARAH AND
COLLEAGUES.
HIS TEAM'S ABOUT INTERESTED IN
[INDISCERNIBLE] WHICH IS
SOMETHING THAT'S ALSO ON THE
TETRAMERS OF ORANGE AND YELLOW
PROTEINS.
AND MASARU'S TEAM HAS BEEN
STUDYING MANY FACETS OF THIS
MOLECULE, LEARNING MORE ABOUT
HOW WE CAN HARNESS AN IMMUNE
RESPONSE TO THIS FEATURE IN THE
CONTEXT OF THE VACCINE, AND THEN
IN STUDY WHAT THEY IDENTIFIED
WAS AN ASPECT BODY THAT DIDN'T
BIND [INDISCERNIBLE] AND HOW IT
WOULD BE POSSIBLE, IT ACTUALLY
BOUND ON THE UNDERSIDE OF THE
NEURAMINIDASE, AND THESE
ANTIBODIES ARE MADE IN VIVO SO
IT TOLD US A LOT ABOUT THE
ANDROGENIC SURFACE OF NA AND HOW
IT SITS AND TILTS AROUND AND
MOVES AND WILL INFORM OUR
EFFORTS TO INCLUDE NA IN OUR
PORTFOLIO OF VACCINE TARGET FIST
FOR FLU.
AS WAS MENTIONED IN THE SPRING
THE DISCOVERY OF H5 IN DAIRY
KALGT AND TRANSMISSION TO HUMANS
GOT OUR ATTENTION.
WE REALLY ESSENTIALLY
IMMEDIATELY PIVOTED TO CAN HOW
COULD WE TRIBUTE TO NIAID'S
RESPONSE TO THIS DEVELOPMENT.
AND IN THOSE VERY EARLY DAYS,
AND THE ABILITY TO GET YOUR
HANDS ON A SAMPLE OF SOMEONE WHO
HAD SEEN THIS CONTEMPORARY H5
SEQUENCE CIRCULULATE NOTHING
KALGT WAS VERY LIMITED.
SO WE WENT BACK TO THE FIRST OF
WHAT THE VRC HAS DONE IN
CLINICAL TRIALS AND ALL THE WAY
BACK TO 2010 WHERE THE VRC HAS
DONE A CLINICAL TRIAL OF AN
HPIEF DNA VACCINE THAT WAS THEN
HOSTED BY ENCATALOGIVATED H5
VIRUS, AND WHAT WE JUST WANT TO
ACKNOWLEDGE IS COULD WE GO BACK
14 YEARS AND FIND B-CELLS IN
THESE PEOPLE THAT WOULD MAKE
ANTIBODIES THAT WOULD SEE THE
VIRUS THAT'S IN CATTLE TODAY.
WE ALSO HAD THIS COOL THING
ABOUT DOING CLINICAL TRIALS WE
HAD 1 VOLUNTEER WHO HAD COME
BACK AND PARTICIPATED IN ANOTHER
TRIAL OF A DIFFERENT CONCEPT,
OUR MOSAIC PLATFORM WHICH IS THE
SPIKY ANTIGEN STRECTURE AND WE
HAD DIFFERENT PEOPLE THAT HAD
DIFFERENT EXPERIENCE ASKS IT
TURNS OUT THAT SARAH ANDREWS WHO
I JUST INTRODUCED HAS LED THIS
EFFORT TO IDENTIFY THE B-CELLS
THAT MAKE THESE H5 2024 REACTIVE
ANTIBODIES.
AND THIS IS A PROJECT THAT'S
STILL ONGOING BUT WHAT I CAN
SHARE WITH YOU IS THAT WE
SUCCESSFUL IN E DENTIFYING
B-CELLS THAT MADE ANTIBODIES
THAT COULD SEE THIS 2024 VIRUS,
THE ANTIBODIES ENCODED BY THOSE
B-CELLS CAN QUITE POTENTLY
NEUTRALIZE H5 CONTEMPORARY
STRAINS AND WE ARE NOW LOOKING
FORWARD TO TESTING THE ACTIVITY
OF THOSE ANTIBODIES IN
COLLABORATION WITH OUR CLOAGS IN
PITTSBURGH THAT 1 OF THE
ORIGINAL BIOLABORATORIES.
THE ABILITY TO DO THIS WAS QUITE
LARGE, [INDISCERNIBLE], WE
LEVERAGED OUR TEAMS,
[INDISCERNIBLE] IS DOING THE
SEQUENCING TO TO HELP US
UNDERSTAND THE DIVERSIFICATION
AND ADAPTIFICATION OF H5 AND
THEN [INDISCERNIBLE]'S GROUP IS
WORKED ON STRUCTURES OF THOSE
ANTIBODIES IN THE CONTEMPORARY
H5.
AT THE END I WANT TO TELL YOU
ABOUT COVID TODAY COMING FROM
BOB CEDARS LAB AND
[INDISCERNIBLE] LABORATORY AND A
COLLABORATION BETWEEN THE 2 AND
WHAT THEY WERE TRYING TO
HAPPENED AS JEANNE MENTIONED,
SHE SAID COVID'S NOT GOING AWAY
AND THAT'S BECAUSE WHILE WE HAVE
A TREMENDOUS VACCINE TO PREVENT
SEVERE ILLNESS, HOSPITALIZATION,
AND DEATH, THE VACCINES DO NOT
PREVENT ACQUISITION OF THE
VIRUS, AND THEY WERE INTERESTED
IN STRATEGIES BY WHICH YOU COULD
DESIGN BOOSTING REGIMENS TO DO
THAT, SO THIS WAS THEIR
EXPERIMENT, TARTED LONG AGO,
WHERE NONHUMAN PRIMATES WERE
IMMUNIZED WITH WHAT WE WERE
GETTING, 2 DOSES, OF 1273 FROM
[INDISCERNIBLE] AT WEEK 32 THEY
GOT A BOOST, AND THAT WAS THE
MRNA AVAILABLE TO US AS THE
STANDARD OF CARE OR THE ANIMALS
WERE BOOSTED WITH A CHIMP-ADD
VECTOR SPIKE THAT WAS DISEVERRED
BY AN INTRA NAISAL SPRAYER THAT
DELIVERED IT TO THE UPPER
RESPIRATORY TRACT OR BY A
NEBALIZER THAT PUSHED THIS
VECTOR INTO THE UPPER AND LOWER
RESPIRATORY TRACT.
THE VECTOR IN THIS CASE IS
DEVELOPED BY MICHAEL DIAMOND'S
BROWP AND PLAYED A SIGNIFICANT
ROLE IN THIS COLLABORATION, THIS
ROLE WAS JUST TO GIVE NIGH EVE
AND HPs THE CHIMP-ADD.
AND WHAT THEY DISCOVERED IS THAT
INTRA NASAL DELIVERY FOR THIS
ANTIGEN, 4 TO 5 MONTHS LATER
WHEN ANIMALS WERE CHALLENGED
WITH THE HETEROLOGOUS VARIANT SO
THE NEWEL EMERGED XPV, THE
NEWEST VIRUS THAT WAS
CIRCULATING SO THISSA SAYS THAT
ELICITING AN ANTIBODY RESPONSE
AND THIS WAS AN IGA DRIIVE
RESPONSE TO THE RIGHT ADDRESS
PROVIDED A POSSIBILITY OF
CONTROLLING ACQUISITION OF THE
VIRUS AND POTENTIALLY
TRANSMISSION, [INDISCERNIBLE],
SO THIS IS AN AREA OF SCIENCE
THAT IS OF CONSIDERABLE INTEREST
TO US NOT ONLY FOR OUR THINKING
ABOUT COVID BUT ALSO OUR ENTIRE
PORTFOLIO OF RESPIRATORY
PATHOGENS.
LAST BIT I WANT TO GIVE YOU AN
UPDATE ON MALARIA.
SO BOB CEDAR'S TEAM HAS BEEN
INTERESTED IN ANTIMALARIAL
ANTIBODIES FOR SOMETIME AND
THAT'S BECAUSE THERE IS A REAL
INTERESTING TARGET OF
OPPORTUNITY FOR ANTIBODIES IN
TERMS OF THEIR ABILITY TO BLOCK
THE INFECTION CYCLE SO BOB'S
TEAMI DENTIFY ASPECT BODY
AGAINST A PROTEIN FOR THE
PROSEEN CSP, THIS IS THE PROTEIN
THAT DECORATES THIS.
WHEN IT IS INJECTED INTO THE
HOST IT HAS A PRETTY--IT DOES SO
IN A PRETTY SMALL NUMBER OF
PARASITES AND WHAT YOU HAVE TO
DO IS JUST PREVENT THEM FROM
GETTING TO THE LIVER WHERE THEN
THEY REPLICATE GREATLY.
AND IN PRECLINICAL STUDIES, IT
BECAME VERY CLEAR THAT
ANTIBODIES AGAINST THE CSP
PROTEIN HAD THE ABILITY TO DO
THAT SO BOB'S TEAM COMBINE
DIFFERENT ANTIBODIES ON THE CSP
AND MANY OF THE GOOD 1S BIND
THESE REPEAT REGIONS THAT ARE IN
THE MITSD OF THAT CSP DIAGRAM ON
THE TOP.
TWO OF THOSE ANTIBODIES WE
TESTED CLINICALLY, CALLED L9 AND
LS, IT IS A TERRIFIC PROJECT
BECAUSE IT IS A COLLABORATION
BETWEEN BOB AT THE VRC, PETER
KRO. TON IS THE DIR AND THE
REGULATORY TEAM OF THE DCR AND
WHAT THE TODAY S&P A STUDY TO
SEE IF YOU CAN PREVENT SEASONAL
TRANSMISSION OF MALARIA IN
CHILDREN 6-10 YEARS OLD BY A
SINGLE SUBCUTANEOUS DOSE OF THIS
ANTIBODY PRIOR TO SEASONAL
TRANSMISSION.
QUHA THEY DISCOVERED IS YOU CAN,
SUBSTANTIALLY 77% PROTECTION IN
THE FIELD IN A MONOCLONAL
ANTIBODY THAT WILL PREVENT THE
ACQUISITION OF INFECTION OR
CLINICAL MALARIA ON THE VIET
RESPECTIVELY.
SO THIS IS YET ANOTHER PIECE OF
CLINICAL INFORMATION THAT
SUGGESTS THAT THIS STRATEGY FOR
PREVENTION IS ATTRACTIVE AND
COULD HAVE A PLACE IN THE
MULTIPLE AVENUES FOR PREVENTING
AND LIMITING MALARIA IN THE
FIELD.
SO BOB'S TEAM IS CURRENTLY
WORKING WITH OUR COLLEAGUES TO
DO ADDITIONAL CLINICAL TRIALS TO
PROVIDE ADDITIONAL SUPPORT FOR
THE NUMEROUS CASE USES THAT YOU
CAN IMAGINE USING AN ANTIBODY IN
THE FIELD AND THAT INCLUDES
PROVIDING VULNERABLE POPULATIONS
AND INDEMMIC REGIONS AND
TRAVELERS AND USE IN PREGNANCY
AND WE LOOK FORWARD TO SOME OF
THESE TRIALS ARE ONGOING, SOME
OF THESE TRIALS WILL WATCH THIS
YEAR.
BUT OUR INVESTMENT IN THIS SPACE
IS BECAUSE DESPITE THE PROMISING
AND REALLY PROMISING ACTIVITIES
RESULTS FROM RECENT TRIALS OF
VACCINES AND SINCE THE EFFICACY
OF CHEMO PREVENTION FROM
MALARIA, WE SEE THERE IS A PLACE
FOR ANTIBODIES BECAUSE IF
CONTRAST TO VACCINES A SINGLE
DOSE OF AN ANTIBODY PROVIDES
IMMEDIATE PROTECTION OVER
PREDICTABLE TIME PERIOD.
MOAN O CLONAL ANTIBODIES ARE
EXPECTED TO WORK ACROSS ALL AGES
AND PROVIDE STERILEAISING
PATHOGEN BECAUSE HAD HAS AN
OPPORTUNITY TO AMPLIFY THE LIST
AND CONTRAST TO DRUGS BA UNITED
STATES A TARGET OF THE ANTIBODY
IS ON THE CSP PROTEIN THAT IS A
SORT OF PREREPLICATIVE STAGE.
IT'S NOT EXPECTED TO SELECT FOR
RESISTANCE OF STRAINS AND
ANTIBODIES WILL GENERALLY BE USE
IN PREGNANCY WHICH WOULD ALLOW
YOU TO DEPLOY ANTIBODIES AS MASS
CAMPAIGNS AS REQUIRED.
SO COST IS REALLY THE OBSTACLE
AND WE ARE WORKING TO SOLVE THE
PROBLEMS FOR I. ELEMENTATION OF
THIS INCLUDING PROCESS
DEVELOPMENT PROBLEMS TO REDUCE
THE COST OF THIS SO THAT'S IT.
I WOULD LIKE TO THANK THE
MEMBERS OF MY TEAM.
THE DIVISION OF COLLEAGUES AND
DIRECTOR AND LEADERSHIP FOR
THEIR CONTRIBUTIONS AND
SUPPORTIVE VRC, AND OUR SIFTS
TRAININGS ANY QUESTIONS?
>> DO WE HAVE TIME?
>> QUICK.
>> OKAY.
>> I WANT TO ASK YOU MENTIONED
COST AS A MAIN OBSTACLE TO
MONOCLONAL ANTIBODIES AND
DESPITE OTHER ADVANTAGES WHICH
IS REALLY INTERESTING, I WAS
WONDERING IF, I THINK IN THE
RSV, CASE, RIGHT?
THERE ARE LOTS OF OTHER
OBSTACLES THAT HAVE SHOWN UP, SO
I WAS WONDERING WHAT YOU THINK
THE ROLE MIGHT BE FOR
IMPLEMENTATION SCIENCE RESEARCH
TO UNDERSTAND WHAT THE OBSTACLES
ARE TO THAT?
>> YEAH, THANK YOU.
WE AGREE THAT THERE ARE MANY
IMPORTANT CONTRIBUTIONS AND
THINGS TO ADDRESS AS YOU THINK
ABOUT BRINGING A MONOCLONAL INTO
A LMIC FOR EXAMPLE, ON B, WE
HAVE A COLLABORATION WITH MMV TO
START THINKING THROUGH AND
ADDRESSING THOSE ISSUES AS WE
WORK TOWARDS IMPLEMENTATION.
BUT THE TRUTH IS WHAT WE NEED TO
DO IS GET AN ANTIBODY WHICH
RIGHT NOW WOULD COST BETWEEN 5
AND TEN DOLLARS A DOSE TO
ARRANGE WHERE IT WOULD BE--TO A
RAINCHL WHERE IT WOULD BE
ATTRACTIVE IN POPULATIONS WHERE
THAT IS A PRETTY BIG OBSTACLE
FOR A NEW PATIENT.
THERE'S NOT 1 PROBLEM, I WOULD
SAY, BUT IF WE CAN'T SOLVE THAT
1 THEN WE'RE NOT IN THE
DISCUSSION.
THANKS FOR THE QUESTION.
THANKS TED, THAT WAS TERRIFIC.