>>SESSION OF THE ADVISORY
COMMITTEE TO THE NATIONAL
INSTITUTE OF ALLERGY AND
INFECTIOUS DISEASES, THIS AS
YOU RECOGNIZE IS AN OPEN
SESSION THIS MORNING SO WE'RE
JOINED BY MEMBERS OF
PROFESSIONAL AND LAY
ORGANIZATIONS TO SHARE COMMON
INTERESTS WITH OURS AND WE
WELL WELCOME YOU AND SHARE
YOUR PARTICIPATION.
NOW, THERE ARE FIVE MEMBERS OF
PROGRESS TO ATTEND THEIR
SERVICE AND THIS GROUP OF FIVE
WILL BE WORKING THROUGH
JANUARY AND WE WILL MARK YOUR
PICTURES AT THE END OF THE
OPEN SESSION SO STAY TUNED, WE
HAVE PLAQUES FOR YOU, ET
CETERA.
WE HAVE FLEE ADHOC MEMBERS OF
COUNCIL TODAY AND I AM PLEASED
ALL THREE OF THEM CAN USE THE
WORD TRANSPLANTATION WHEN IT
COMES TO WHAT THEY DO AND TWO
OF THEM COME FROM SURGERY SO
WELCOME TO ALL THREE OF THEM.
THEY ALL HAVE DISTINGUISHED
RECORDS BUT I THINK THIS MAY
BE THE FIRST TIME WE HAVE A
MEMBER SERVING ON COUNCIL WHO
IS IN THE BEGIN NET BOOK OF
WORLD RECORDS.
ROBERT IS RESPONSIBLE FOR
EIGHT TRANSPLANTS ORGANIZED IN
A CERTAIN DAY WHICH HE
WITNESSED A DOMINO TRANSPLANT
WHERE YOU TAKE ATTORNEYS AND
PATIENTS AND SWITCH THEM UP
WITH OTHERS FOR A SEQUENCE
THAT ENABLES THEM TO RECEIVE
ORGANS AND THAT WAS ONLY ONE
OF A NUMBER OF INCREDIBLE
THINGS THAT HE HAS DONE SO
WELCOME.
OUR FIRST ORDER OF BUSINESS IS
TO APPROVE THE MINUTES OF MY
LAST MEETING.
THE MINUTES SHOULD BE IN YOUR
COUNCIL ELECTRONIC BOOKS.
ANY QUESTIONS, COMMENTS OR
DIRECTIONS AS TO THE MINUTES
THE COUNCIL HAD AT LAST
SESSION, LET ME KNOW,
OTHERWISE CAN I HAVE A MOTION
TO APPROVE THE MINUTES.
SECONDED, ALL IN FAVOR, AYE,
ANY OPPOSED, THANK YOU,
ANDREA, THE MINUTES ARE NOW
APPROVED.
BIG ANNOUNCEMENT.
THIS IS OUR BIGGEST
ANNOUNCEMENT.
YOU ARE PROBABLY AWARE THAT
JENNY HAS BEEN ANNOUNCED AS
THE NEXT NIAI ID DIRECTOR,
BEEN DIRECTOR AT UNIVERSITY OF
ALABAMA, PHYSICIANS IN TENURE
TRACK, ON THE BOARD OF NSA AND
WELL QUALITY FIGHT TO BE OUR
NEW DIRECTOR AND WE CAN'T WAIT
TO WELCOME HER HERE.
WE WANT TO BRING HER IN
SPLENDOR SO WE'RE PREPARING
HER OFFICE FOR HER AND IT
LOOKS LIKE THIS AT THIS POINT.
THOSE OF YOU WHO HAVE SEEN
Dr. FAUCI''S OFFICE IN THE
PAST, THIS IS WHAT IT LOOKS
LIKE.
AND THEN IF YOU TURNED AROUND
AND LOOKED AS WHERE MY OLD
OFFICE USED TO BE, IT LOOKS
EXACTLY LIKE THIS AS WELL.
THE GOOD NEWS IS THE ASBESTOS
IS GONE.
THE BAD NEWS IS THE RENOVATION
ITSELF ON THE BE COMPLETED
TILL 204 SO DON'T HOLD YOUR
BREATH.
IN THE MEANWHILE, ALL OF US
HAVE MOVED TO THE OPPOSITE END
OF THE FLOOR IN CUBBY HOLES SO
IT WON'T REALLY BE REBOTTLE
SPLENDOR WHEN SHE ARRIVES
HERE.
OVER THE WEEKEND, BERNIE
SANDERS ANNOUNCED HE WILL HOLD
CONFIRMATION HEARINGS FOR
MONICA BERTAGNOLLI IN OCTOBER.
THIS COMES FROM A CONTRACT
THAT HAS A FARE PRICING CLAUSE
IN IT SO IS AN INDICATOR TO
HIM THAT WE'RE DOING SOMETHING
TO CONTROL DRUG PRICES.
I SUSPECT THE PERSON MOST
EXCITED ABOUT THIS IS ACTUALLY
LARRY TABAK.
OTHER APPOINTMENTS AROUND THE
GOVERNMENT, MANDY COHEN HAS
TAKEN OVER AS CDC DIRECTOR,
CHIEF OF STAFF AND CHIEF
OPERATING OFFICER OUT OF THE
CENTER FOR MEDICARE AND
MEDICAID SERVICES.
LET ME PUT THIS -- THIS IS
UNDER THE OBAMA
ADMINISTRATION.
COHEN.
LET ME PUT THIS IN PERSPECTIVE
FOR YOU.
THE BUDGET IS 1.4 TRILLION,
THE BUDGET FOR CMS IS
$1.3 TRILLION.
SO THIS IS THE CENTER OF ACT
ACTIVITY FOR HHS.
MANDY COHEN WAS THE DIRECT
DIRECTOR OF NORTH CAROLINA
HEALTH AND HUMAN SERVICES
RIGHT IN THE MIDST OF THE
PANDEMIC SO SHE HAS HAD LOTS
OF EXPERIENCE IN THE PUBLIC
EYE.
IN THE WHITE HOUSE, THERE IS
NOW AN OFFICE OF NATIONAL
PREPAREDNESS AND RESPONSE,
THIS JUST AS STEVE WAS LEAVING
AND WE NOW HAVE PAUL
FRIEDRICHS ASSUMING THE
OFFICE.
HE IS A RETIRED MAJOR GENERAL
IN THE AIR FORCE, AN MD.
HE WAS THE SURGEON COMMAND IN
THE JOINT STAFF.
HE ALSO HAPPENS TO BE A HIGHLY
DECK DECORATED FIGHTER COMBAT
PILOT.
I HAVEN'T EVER MET HIM BUT
HAVE THE IMPRESSION YOU
WOULDN'T WANT TO TANGLE WITH
PAUL FRIEDRICHS.
NOW WE'RE GOING TO HAVE ABOUT
TEN OR 15 SLIDES ABOUT
PROMOTIONS HERE AT NIAID AND
NIH.
MANY OF THESE PEOPLE YOU WON'T
KNOW BUT I THINK IT IS USEFUL
FOR THE STAFF TO SEE THEIR
COLLEAGUES AND PEERS AND
USEFUL FOR COUNCIL MEMBERS TO
GET A SNAP SNAPSHOT OF THE
WORKFORCE.
SO JANE SIMONI HAS BEEN
SELECTED AS DIRECTOR OF THE
OFFICE OF BEHAVIORAL AND
SOCIAL SIGNS RESEARCH, NIH
APPOINTMENT.
SHE HAS AN EXTENSIVE
BACKGROUND.
IS A CLINICAL PSYCHOLOGIST BUT
HAS A TROPICAL SYSTEM
TREMENDOUSLY DOUSE AMOUNT OF
WORK WITH HIV.
ANOTHER ANNOUNCEMENT IS PATTY
GRENNAN, DIRECTOR OF THE
NATIONAL LIBRARY OF MEDICINE
FOR SEVEN YEARS AND BEEN A
BUNDLE OF ENERGY TO MAKE THE
NATIONAL LIBRARY A GLOBAL
RESEARCH LIBRARY FOR
EVERYBODY.
MOVING INTO NIAID
APPOINTMENTS, KELLY POE HAS
BEEN NAMED AS DIRECTOR OF THE
DIVISION OF INTRAMURAL
ACTIVITIES.
KELLY CAME TO NIH TO BE
DIRECTOR OF INTRAMURAL
ACTIVITIES AS SCIENTIFIC
REVIEW DIRECTOR, BECAME THE
DEPUTY DIRECTOR OF THE REVIEW
PROGRAM, BECAME DEPUTY
DIRECTOR OF DA AND ACTING
DIRECTOR OF DEA AND NOW
FINALLY THE ACTUAL DIRECTOR OF
DEA.
IT IS A TERRIFIC APPOINTMENT
FOR ALL OF US.
WE HAD TO TWIST SOME ARMS TO
GET ANDREA TO SERVE AS ACTING
DIRECTOR.
SHE CAME TO NIH AND NIAID IN
2011 AND WHENEVER I NEED TO
KNOW WHAT IS SUPPOSED TO
HAPPEN IN DEA, I CALL UP
ANDREA WURSTER AND SHE ALWAYS
KNOWS THE ANSWER.
THE DIRECTOR OF THE OFFICE OF
DATA SCIENCE AND EMERGING
TECHNOLOGIES, SH ABMAN
SELECTED AS DEPUTY DIRECTOR
AND A GOOD ADDITION HERE.
AN EXPERIENCED PEDIATRICIAN
OVERSEAING CLINICAL TRIALS IN
D IRA IDS FOR YEARS, THIS WILL
BE A TERRIFIC APPOINTMENT FOR
AIM KNEE YEN.
NOW, PEOPLE ASK ME WHAT IS
OSPIDA.
IT IS THE OFFICE OF STRATEGIC
PLANNING, INITIAL DEVELOPMENT
AND ANALYSIS BUT I STILL DON'T
KNOW WHAT THEY DO.
I ASKED JOHANNA SCHNEIDER WHAT
IS IT YOU DO AND SHE SAID WE
ARE THE DEEP STATE OF NIAID.
NOBODY KNOWS WHAT WE DO BUT WE
GET IT DONE.
INDEED I WANT TO MENTION THAT
ONE OF THE PEOPLE WHO WORKS IN
OSPI IDA IS LAURA MILLER WHO
WAS GIVEN THE ASSIGNMENT TO
PREPARE THE SLIDES AND
BACKGROUND MATERIAL FOR MY
COMMENTS THIS MORNING AND I
APPRECIATE THE EFFORT YOU PUT
IN, WORKING THROUGHOUT THE
WEEKEND AS I MADE CHANGES IN
THE SLIDES SO THANK YOU,
ANOTHER OSPIDA FUNCTION.
RESEARCH AND ANALYTICS BRANCH,
JOHN NIE E AND CHIEF AND
ANALYSIS BRANCH BRENDA LEE AND
THAT WILL BE A PROMOTION FOR
HER WITHIN THE ORGANIZATION.
NOW A TRANSITION IN JULY WE
RELUCTANTLY CELEBRATED THE
RETIREMENT.
WENT ON FOR PAGES AND I
COULDN'T GET THROUGH ALL OF
THEM BUT WHILE THE PANDEMIC
STUDY -- -- WAS GOING ON,
COMPLETED THE STUDY AND THE
CHILDREN'S NETWORK, MARY WAS
GIVEN ENORMOUS RESPONSIBILITY
TO MAKE THAT HAPPEN.
THERE WERE A NUMBER OF PEOPLE
WITHIN NIAID WHO WORKED
INCREDIBLY HARD AND NOBODY
WORKED HARDER IN MY MIND THAN
MARY MARAVICH, ACTING DIRECTOR
OF THE RESEARCH PROGRAM.
MARK WILL BE RETIRING AS THE
CHIEF OF VILLAGE BRAN V -- --
VIROLOGY BRANCH, YOU HEARD
ABOUT THESE PROGRAMS IN THE
PAST BUT MARK WAS MAKING IT
HAPPEN AND GENE WILL NOW BE
ACTING DIRECTOR OF THE
VIROLOGY BRANCH.
THE HHS SECRETARY GIVEN TO
JOHN BYVAL AND ALLEN POE.
THESE TWO PEOPLE I THINK TIE
MARY FOR HARD WORK DURING THE
COVID RESPONSE.
JOHN WAS FIRST OFF THE MARKET
RUNNING A TREATMENT TRIAL FOR
THIS COV2 VIRUS AND PROVING
EARLY ON REMDESIVIR WAS
EFFICIENT FOR IT AND HE WAS
ONE OF THOSE WHO GOT THE STUDY
DONE.
THE TREATMENT GUIDELINES PANEL
FOR COVID, THEY FIRST ISSUED
THEIR GUIDANCE AND SINCE
REVISED THEIR GUIDELINES AND
UPGRADED THEM 68 TIMES AND THE
SITE HAS RECEIVED 48 MILLION
PAGE HITS OVER THE COURSE OF
THE PAF TWO AND A HALF -- PAST
TWO AND A HALF YEARS SO IT IS
A STRIDE NARROW EFFORT AND SHE
WAS CORRALLING TERRIFIC
EFFORTS DURING THESE
GUIDELINES.
THEN A VERY SPECIAL AWARD FROM
HHS AND A WORD FOR EXCELLENCE
IN MANAGEMENT TO EMILY
LENDING, CHIEF OF THE GRANTS
MANAGEMENT PROGRAM.
NOW, IF YOU HAVE TO IMAGINE
OVER THE PAST THREE YEARS, WE
RECEIVED AN ADDITIONAL
$5 BILLION FOR OUR COVID
RESPONSE WHICH MEANS A VERY
HEAVILY PACKED BRANCH, THE
BRANCH MANAGEMENT BRANCH, HAD
A 50% INCREASE IN ITS WORKLOAD
OVER THE COURSE OF THE THREE
YEARS.
IN ADDITION TO THAT, I THINK
AS WE MENTIONED LAST TIME, WE
HAD THE COVID FUNDING
RECESSION WHERE THE FUNDING
WAS GOING TO BE REMOVED IF WE
DIDN'T GET DOLLARS OUT THE
DOOR WHICH REQUIRED REWRITING
HUNDREDS OF MILLIONS OF
DOLLARS OF GRANT ACTIONS TO
GET ALL THE MONEY OUT THE DOOR
ON AN ANNUAL SEQUENCE AND NOW
FOLLOWING THAT, IMMEDIATELY
HAD TO TURN INTO THE END OF
YEAR CHAOS WHICH HAPPENS HERE
IN AUGUST AND SEPTEMBER.
EMILY LIND DEAND -- LINDY AND
HER STAFF ARE THE MOST
ESSENTIAL PEOPLE HERE AT
NIAID.
I REALLY DO NOT KNOW HOW WE
WOULD FUNCTION IF WE DID NOT
HAVE THEM AT THE REALM.
THIS IS THE THIRD HIGHEST
AWARD AWARDED BY THE SECRETARY
HIMSELF AND TOTALLY DESERVED
BY EMILY LINDY.
OTHER THINGS GOING ON AROUND
NIH, WE HAD A GROUNDBREAKING
FOR THE NEW WING WHICH WILL BE
FOR RAID RADIOLOGY, LABORATORY
AND MEDS CITIZEN.
SHE IS EVENTS ARE SOMETIMES
HOKIE EVENTS BUT THIS ONE WAS
NICE.
I GET THAT EARLY -- I GET
THERE EARLY, AS I WORKED FOR
Dr. FAUCCI FOR YEARS, BUT I
GET THAT EARLY AND THERE WAS
TALK ABOUT HOW THEY WERE
PETITIONING WARREN TO TAKE THE
HOLD OFF THE CONFIRMATION
HEARING.
THERE ARE TWO RSIS -- ABOUT
KNOWLEDGE FOR HEALTH LINK AND
LIGHT AND OPTIMIZE HEALTH FOR
ALL PEOPLE, IF YOU WANT TO
CHOOSE TO COMMENT ON THIS, DO
SO BY DECEMBER 24TH.
THERE IS ALSO A RFI OUT TO
COMMENT ON QUESTIONS POSED ON
THE POSITIONS OF OUR DIRK AND
CPO OVERSIGHT POLICIES.
THE PASSION OF RFI PUT OUT
SEVERAL QUESTIONS TO YOU BUT
IT DOES NOT INCLUDE THE DRAFT
OF THE PROPOSED DIVISIONS BUT
I CAN TELL YOU THE SUMMARY OF
THOSE.
DUKE RESEARCH AND CONCERN USED
TO TILL NOW INVOLVE 15
PATHOGENS AND THE 7 DEADLY
SINS AS WE CALLED THEM.
PCO, PATHOGENS OF PANDEMIC
POTENTIAL, THE THREE P'S, CARE
AND OVERSIGHT.
CO, OKAY, THAT HAS BEEN
MODIFIED IN THE DRAFT FORM
WHERE IT USED TO BE -- WE
WOULD WORRY ABOUT ENHANS D
PATHOGENS OF POTENTIAL --
PANDEMIC POTENTIAL OF
INCREASED TRANSADMISSIBILITY
AND HIGHLY LIKELY
INCREASED VIRILENCE.
THE NEW ONE SAYS MODERATE
POTENTIAL OF INCREASED
TRANSMISSIBILITY AND
MODERATELY
INCREASED VIRILENCE.
I THINK THAT SHOWS YOU HOW WE
HIGHLIGHT THIS RESEARCH.
A COUPLE OF ACTIVITIES TO
MENTION.
WE HAD A NICE MEETING WITH
DENISAGEORGI, SHE HAS WORKED
IN A NUMBER OF POSITIONS BUT
WILL NOW BE THE HEALTH PASSE
OF INDIA AND I WILL BE HEADED
OVER TO INDIA FOR THE HEALTH
PASSION PROGRAM WHICH I THINK
IS IN ITS 37TH YEAR AND LOOK
FORWARD TO HOOKING UP WITH HER
THERE.
WE ALSO HAVE HEALTH AND
SCIENCE TECHNOLOGY.
YOU ARE PROBABLY AWARE THAT
HIGH-LEVEL WORK OF THE UNITED
STATES HAS BEEN DONE IN CHINA
OVER THE LAST YEARS AND HAS
BEEN A VISIT LAST MAY OF
DEPUTY DIRECTOR HSU WHO CAME
TO SEE US AT NIAID AND I THINK
THAT MAY BE AS HIGH A LEVEL
FROM A CHINESE GOVERNMENT
OFFICIAL FOR THE PAST SEVERAL
YEARS.
WE CONTINUE TO HAVE EVERY
OTHER MONTH CALLS WITH
SCIENTISTS -- MINISTRY OF
SCIENCE AND TECHNOLOGY WITH
OUR SCIENTISTS JOINING THEM SO
THAT CONTACT CONTINUES
OBVIOUSLY WITH THE KNOWLEDGE
AND BLESSING OF OUR STATE
DEPARTMENT.
BUDGET UPDATE.
THIS IS NOT GOING TO BE GOOD.
THIS IS THE BUDGET WE'RE
CURRENTLY LIVING WITH IN
FISCAL YEAR '23.
THERE WAS A INCREASE OF ONLY
3.8 PERCENT WHICH WAS LESS
THAN OTHER INSTITUTES WHICH
WAS REALLY IRRITATING COMING
OFF THE END OF THE PANDEMIC,
NONETHELESS, IT WAS AN
INCREASE AND WE WERE ABLE TO
CONTINUE FUNCTIONING.
THIS IS A PICTURE I THINK I
HAVE SHOWN YOU BEFORE, NIAID
IN RELATIVE TERMS, THE SECOND
LARGEST OF THE NIH INSTITUTES.
WHILE I HAVE BEEN HERE, THE
CIRCLE IN THE UPPER RIGHT OD,
OFFICE OF THE DIRECTOR, HAS
GONE FROM BEING THE SIZE THERE
ON THE LEFTHAND SIDE WITH THE
GREEN DO THE OF THE FOGGARTY
CENTER, THAT WAS THE SIZE OF
THE DIRECTOR WHEN I GOT HERE,
YOU CAN SEE ITS SIZE AT THIS
POINT.
THE OTHER BIG GROWTH AREA HAS
WITHIN THE NATIONAL INSTITUTE
OF AGING IN PINK WHICH OF
COURSE AS BABY BOOMERS GET
OLDER, THERE IS INCREASED
ACTIVITY AT ANY NIH.
NOW THIS IS A PICTURE OF NIAID
FUNDING OVER THE PAST 20 OR SO
YEARS.
I GOT HERE, I THINK, IN 2006
AND YOU CAN SEE WE HAD A
PROLONGED PERIOD OF FLAT
BUDGETS WHICH OF COURSE WAS
NOT REALLY FLAT WHEN YOU
FACTOR IN INFLATION.
THE LAST EIGHT YEARS HAVE BEEN
PRETTY GOOD SO YOU HAVE SEEN
THE INCREASES OVER THAT PERIOD
OF TIME.
THE DISTURBING NUMBER IS THE
LAST ONE WITH THE PRESIDENT'S
BUDGET REQUEST FOR 2024 WHICH
IS FLAT.
THAT IS COMING FROM THE BIDEN
ADMINISTRATION AND A
DEMOCRATIC ADMINISTRATION.
WE WERE USED TO SEEING A
BUDGET UNDER PRESIDENT TRUMP
WHICH RECEIVED A 25 PERCENT
CUT WHICH WE PAID NO ATTENTION
BECAUSE WE KNEW CONGRESS WAS
GOING TO RESCUE IT.
THIS IS NOT TO BE EXPECTED
THIS TIME AROUND, MAKING A
25 PERCENT CUT IN THE BUDGET
AT NIAID.
THIS IS APPROPRIATIONS AT THIS
POINT, THE HOUSE APPROPRIATION
COMMITTEE RECOMMENDED A
22 PERCENT CUT IN THE BUDGET
OF NIAID AND YOU CAN IMAGINE
THERE IS A LITTLE RETRIBUTION
IN THAT.
THE SENATE HAS RECOMMENDED A
0 PERCENT INCREASE IN THE
BUDGET AND OF COURSE THE BEST
WE CAN COME OUT WITH IN THE
FALL WILL BE A CONTINUING
RESOLUTION, NOT THAT A BUDGET
WILL BE PASSED, WE COULD GO
INTO A SHUTDOWN AND NOT TO GET
POLITICAL HERE BUT WE HAVE NO
IDEA WHERE THINGS WILL END UP
BUT IT DOES NOT LOOK GOOD FOR
AN INCREASE AND THERE COULD BE
A DECREASE FOR FUNDING AT
NIAID IN THE COMING YEAR.
WITH THAT IN MIND, OUR INTERIM
MANAGEMENT PLAN INVOLVES A 8TH
PERT TILE -- PERCENTTILE PAY
LINE WITH 12 PERCENT FOR
INVESTIGATORS AND I THINK THAT
IS AS BAD AS WE HAVE STARTED
ANY YEAR.
WITH THIS LINE, WE SHOULD NOT
EXPECT TO HAVE CHANGES OR
DOWNWARD PROJECTIONS BUT NIH
IS DISCUSSING A ACROSS THE
BOARD 10 PERCENT CUT IN
NONCOMPETING AWARDS THIS YEAR.
WE WILL DIG HEAVILY INTO OUR
COMPETING RESEARCH INITIATIVES
IN ORDER TO DO THE BEST THAT
WE CAN TO PROTECT OUR PAY LINE
BUT THE SUCCESS RATES
ANTICIPATED THERE ARE
DISCOURAGINGLY LOW, EVEN FROM
THE TIME WHEN THEY HAVE BEEN
DISCOURAGINGLY LOW FOR A
WHILE.
NOW I WILL RECAP SOME OF THE
EXTRA FUNDING WE GOT FOR COVID
OVER THE PAST TWO YEARS.
WE MENTIONED IT BEFORE.
WE GOT AN APPROPRIATION OF
$1.5 BILLION.
A LARGE PORTION OF THAT WAS AT
RISK WHEN THEY ANNOUNCED ANY
PENDING MONEY THAT HAD NOT
GONE OUT THE DOOR WOULD BE
CONFISCATED OR TAKEN BACK AS
OF JUNE 1ST AS PART OF THE
BUDGET CEILING NEGOTIATIONS.
IN THE END, WE ONLY LOST
$3 MILLION BECAUSE OF THE
EXTRAORDINARY HARD WORK OF OUR
GRANTS MANAGED PROGRAM.
AND ON TOP OF THAT 1.5, WE
ALSO RECEIVED MORE THAN
$3 BILLION THROUGH WHAT WAS
MOST RECENTLY CALLED H-CORE
BUT WAS ORIGINALLY OPERATIONS
WORK AND THIS IS MONEY THAT
FLOWED TO US FROM THE KEPT
DEPARTMENT OF HEALTH AND HUMAN
SERVICES SO YOU COULD SEE WE
HAD A VERY LARGE INFUSION OF
COVID FUNDING DURING THIS
TIME.
LEGISLATIVE UPDATE, THIS IS A
VERY SHORT LIST COME FIRED
WHAT YOU HAVE SEEN IN THE PAST
AND YOU NOTICE MY NAME IS ON
ON THERE -- NOT ON THERE AS
WELL.
I HAVE NOT HAD ANY INTERACTION
WITH CONGRESS AND THE
LEGISLATIVE OFFICE HAS WORKED
HARD TO KEEP IT THAT WAY.
THANK YOU EMILY AND JOE FOR
THE WORK THAT YOU DID.
AND THIS GROUP HAS BEEN
HANDLING A BARAGE OF REQUESTS
FOR INFORMATION FROM CONGRESS
THAT HAS REALLY BURDENED THEM
IN THE PAST THREE TO FOUR
MONTHS.
NOW SOME DISEASE UPDATES IN
SECOND AREAS, FIRST COVID-19,
I THINK YOU ARE AWARE THAT
THERE IS A SURGE OF
HOSPITALIZATIONS.
THERE IS NOT A SCORES
RESPONDING -- CORRESPONDING
SURGE IN DEATHS FROM COVID.
IF YOU GO BACK AND LOOK AT THE
WASTEWATER, YOU CAN SEE THAT
IT WAS HIGH BEFORE THE SURGE
SO THERE MAY HAVE BEEN PEOPLE
WHO WERE SICK AND DIDN'T KNOW
IT.
WITHIN THE LAST FEW WEEKS,
THERE HAVE BEEN A NUMBER OF
PEOPLE WHO GOT COVID SO IT IS
OUT THERE.
THE FDA ADVISORY COMMITTEE
BACK IN JUNE UNANIMOUSLY
RECOMMENDED THAT DURING THE
FALL, THERE SHOULD BE
IMMUNIZATION WITH XBB LINEAGE
OF OMICRON, SO THAT WAS THEIR
RECOMMENDATION.
TOMORROW, ASA, ADVISORY
COMMITTEE ON IMMUNIZATION
PRACTICES WHICH IS THE CDC
ADVISORY COMMITTEE, TOMORROW
THAT GROUP WILL MEET AND I
SUSPECT THEY WILL COME UP WITH
THE SAME RECOMMENDATION BUT
WHETHER IT WILL BE FOR
EVERYBODY OR OLD PEOPLE, I CAN
TELL YOU MY LAST BOOSTER WAS A
YEAR AGO AND I AM TOTALLY
HAPPY TO GET ANOTHER COVID
SHOT.
I HAVE HAD MAYBE THREE
MODERNA, TWO PFIZER ALONG WITH
THE VACCINE ROUND.
SO THE WHITE HOUSE HAS
LAUNCHED SOMETHING CALLED
PROJECT NEXT GEN, THE PARTING
PROGRAM INITIATIVE AND IN
PARTNERSHIP WITH US BUT WE'RE
A RELATIVELY SMALL COMPONENT
TO IT.
ORIGINALLY WE WERE ALLOCATED
$3 BILLION OUT OF A $5 BILLION
SET-ASIDE.
WE HAVE ADDED SOME OF OUR OWN
FUNDING TO GET CLOSE TO
$5 MILLION FOR VACCINE TRIALS
AS A PROPOSAL FOR IMMUNITY OR
BROADER IMMUNIZATION TUBE TO
THE VIRUS SO WE ARE PART OF
THIS.
HIV AIDS, THIS IS THE 20TH
ANNIVERSARY OF PEPTAR, ONE OF
THE MOST SUCCESSFUL HEALTH
PROGRAMS OF ALL TIME, THE
PEOPLE IN SUBSAHARA AFRICA
RECEIVING TREATMENT, AROUND
65 MILLION AND YET THE RENEWAL
OF PETFAR IS IN SERIOUS
TROUBLE UNDER CLAIMS IT
CREATES ABORTION WHICH IT
DOESN'T BUT JUST OVER THIS
WEEKEND, THERE WAS WRITING
ABOUT THE THREAT OF GLOBAL
HEALTH AS A RESULT OF THE
UNCERTAINTIES THAT WE WILL
ACTUALLY BALLOON THE PETFAR
PROGRAM.
ANOTHER ITEM IN THE HIV AREA
IS THE RECOGNITION BY THE
PREVENTIVE SERVICES TASK FORCE
OF THE UNITED STATES THAT THEY
WOULD GIVE A GRADE A
RECOMMENDATION TO GIVING PREP
TO HIGH RISK INDIVIDUALS.
THAT SHOULD MEAN THAT THAT
TREATMENT, THAT PREP WOULD BE
COVERED BY INSURANCE.
I THINK THIS IS A MAJOR
ACHIEVEMENT AND THE EVIDENCE
TO SUPPORT THIS GRADE A
RECOMMENDATION ALMOST ENTIRELY
COMES FROM THE WORK OF NIAI
ID.
THERE HAS BEEN A SLOW DECREASE
IN THE INCIDENTS IN THIS
COUNTRY.
TO SOME EXTENT I SUPPOSE THAT
MAY BE THE RESULT OF THE END
OF THE HIV EPIDEMIC INITIATIVE
THAT DATES BACK TO 2019.
THE GOAL FOR THAT OVERALL
PROGRAM WHICH IS NOW FUNNED
AND MANDATED -- FUNDED AND
MANDATED BY CONGRESS IS NOW A
30 YEAR PROGRAM TO 2030.
IT IS PARTICIPATION SCIENCE
AND ROUGHLY $85 MILLION HAS
BEEN ALLOCATED TO THIS EFFORT
AND MORE THAN 200-PLUS
SUPPLEMENTS HAVE BEEN AWARDED.
WE TOLD YOU BEFORE ABOUT THE
REPRIEVE STUDY AND ITS RESULTS
BUT THE STUDY RESULTS WERE
JUST PUBLISHED BY THE NEW
ENGLAND JOURNAL OF MEDICINE IN
LATE AUGUST AND IT IS AN
ASTOUNDING OUTCOME IN ADVERSE
CARDIAC EVENTS FOR PEOPLE WHO
HAVE BEEN IN TREATMENT AND
THIS IS ANOTHER MAJOR
ACCOMPLISHMENT OF TREATMENT OF
AIDS.
AND THEN ANOTHER PAPER
PUBLISHED TALKING ABOUT THE
BODIES WITH A THIRD ARM THAT
IS A NEUTRALIZING ANTIBODY, TO
STIMULATE LATENTLY EXPRESSING
CELLS SO IF THEY DO EGGS
SUPPRESS THE -- EXPRESS HIV
VIRUS, THEY NEUTRALIZE THE
ANTIBODY ARM SO THIS PROOF OF
CONCEPT WAS ENCOURAGING.
NOW WE'RE GOING TO TALK A
LITTLE BIT ABOUT MEDICAL
COUNTER MEASURES VERY CLOSE TO
THE FINISH LINE.
OFTEN WHEN WE TALK TO YOU
ABOUT VACCINES AND OTHER
COUNTER MEASURES, WE TALK
ABOUT RESULTS THAT HAVE COME
WITH MONKEYS OR FERRETS.
EVERYTHING I AM ABOUT TO TELL
YOU IS ABOUT CLINICAL RESULTS
THAT HAVE COME FROM A GROUP OF
VACCINES.
FIRST IN 2013, PEOPLE QUONG
TEAMED UP WITH BARNEY GREEN
AND JASON MCLELLAN TO
DETERMINE THE STRUCTURE OF THE
F PROTEIN IN ITS PREFUSION
STATE THAT SITS ON THE SURFACE
OF THE HSV.
THEY-- RSV.
THEY ALSO LEARNED THIS
UNSTABLE MOLECULE NEEDS TO BE
STABILIZED IF IT IS GOING TO
BE A GOOD IMMUGEN.
THE RESULTS WERE PUBLIC BEFORE
I HAD -- PUBLISHED AFTER 20
YEARS OF A STUDY AND NOW WE
HAVE FDA APPROVAL FOR SEVERAL
PRODUCTS, THE MONOCLONAL
ANTIBODY AGAINST RSV RECEIVED
APPROVAL FROM AS HAVE A
SENECA -- ASTRA ZENECA AND A
THIRD VACCINE FOR PREGNANT
WOMEN TO EXTEND THE IMMUNITY
TO THE UNBORN CHILD IS THIS
HAS BEEN AN AMAZING YEAR FOR
THE RESEARCH CENTER.
THE OTHER APPROACH TO RSV
VACCINOLOGY COMES OUT OF THE
INTRAMURAL PROGRAM WITH THE
LIVE ATTEN UNITED VACCINE,
GOING ON FOR DECADES AND NOW
THE WORK OF ZULA WITH A LIVE
ATTEN UNITED VACCINE FOR
YOUNGER CHILDREN AND THIS HAS
BEEN PROMISING AS WELL WITH
RESULTS.
THERE WAS FDA APPROVAL OVER
THE LAST FOUR MONTHS FOR A
TWO-DAYS PROPHYLAXIS FOR A
ANTHRAX VACCINE.
THERE IS -- THIS IS THE STEVE
WHITEHEAD PETROVAILANT DENGKE
VACCINE HE HAS BEEN WORKING ON
SINCE I GOT HERE AND YOU CAN
SEE THE PHASE 3 TRIAL IN
BRAZIL WITH 80 TO 90 P-Z
EFFICACY.
TRIALS GOING ON IN AFRICA AND
IT IS VERY LIKELY THIS WILL
END UP BEING THE VACCINE IN
THE FUTURE WORLDWIDE.
WE HAVE BEEN TALKING ABOUT
FLU VACCINES FOR A LONG TIME.
NOW WE ARE IN PHASE 1 TRIALS
OF THE VACCINE AT RESEARCH
CENTERS INCLUDING THE SIX
INFLUENZA STRAINS AND THAT IS
A OPEN LABEL 1 STUDY.
THE INTRAMURAL STUDY, DIR,
JEFF KOHENBERGER AND EMILY ARE
WORKING ON THEIR VACCINE WHICH
CONTAINS IMMUONOGENS COMBINED
AND THEY ARE NOW IN PHASE 1
WORKING ON THAT COHORT WITH
PATIENTS.
THE VACCINE BASED ON M72
RECOMBINANT FUSION PROTEIN
WHICH WE WERE INVOLVED IN THE
EARLY WORK GETTING DEVELOPED
BUT THIS WILL BE TAKEN TO A
PHASE 3 STUDY BY THE BILL AND
MELINDA GATES FOUNDATION.
THERE IS A CHICKEN PARTICLE
THAT CAME DIRECTLY OUT OF THE
VACCINE RESEARCH CENTER WHICH
HAS SHOWN TREMENDOUS EFFICACY
IN CLINICAL TRIALS WITH PLANS
TO TAKE IT TO THE FDA EARLY
NEXT YEAR FOR REGULATORY
APPROVAL.
THE DRC ALSO HAS A SUDAN EBOLA
VIRUS, THE OTHER APPROVED
EBOLA VACCINES DO NOT
CROSS-REACT ON THE SUDAN
SUB-TYPE SO THIS IS ANOTHER
HELP FORWARD FOR THE VACCINE
RESEARCH CENTER.
AND FINALLY I JUST WANT TO
REMIND YOU ABOUT THE SAFETY
AND EFFICACY OF THE MONOCLONAL
ANDY BODY FOR MALARIA WHICH
SHOWS WILL -- 88 PERCENT
EFFICACY WITH A SINGLE SHOT IN
THE REGION.
SO ALL OF THIS MEANS THESE
PRODUCTS ARE REALLY ON THE
ROAD TOWARDS REGULATORY
APPROVAL.
THIS IS THE YEAR FOR THE RSV,
RACING TO THE FINISH LINE.
THE COVID VACCINES WERE
ALREADY OVER THERE BUT I HAVE
MENTIONED TO YOU, THE DENGKE,
MALARIA, CHICKEN VARIANT ARE
REALLY RACING TOWARDS FDA
APPROVAL SO IT IS A
SPECTACULAR TIME.
THIS VACCINE HUFFING AND
PUFFING IN THE BACKGROUND
THERE BUT THE FACT OF THE
MATTER IS THE SUCCESS OF THE
RSV PROGRAM DEPENDED ENTIRELY
ON THE WORK PETER QUONG DID TO
UNDERSTAND THE STRUCTURE OF
STABILIZATION OF HIV GLYCO
PROTEIN SO IT IS A DIRECT
PRECURSOR SO THE EFFECT OF THE
RSV VACCINE.
SIMILARLY, IT IS A DIRECT
PRECURSOR TO THE COVID VACCINE
WHICH BARNEY REALIZED HOW TO
STABILIZE AND MADE SUCCESSFUL
VACCINES FOR COVID IN LESS
THAN A YEAR.
VERY BRIEFLY A COUPLE OF
UPDATES TO MENTION TO YOU,
THIS HIGHLIGHTS THE FACT THAT
THE FOOD AND DRUG
ADMINISTRATION HAS APPROVED A
TREATMENT FOR CHAPEL DISEASE.
THIS HAS BEEN IDENTIFIED IN
THE CLINICAL CENTER THAT MIKE
LEONARDO WAS ABLE TO DETERMINE
THE BASIS FOR THIS DISEASE WAS
A GENETIC SUFFICIENCY IN CD55
WHICH IF YOU ARE OLD ENOUGH,
WE USED TO CALL DECELERATING
FACTORS.
THE BOTTOM LINE IS WITHOUT
THIS COMBINATION YOU HAD RUN
AWAY ACTIVATION IN THIS
SYNDROME AND THE RESULT OF
THAT IS A PROTEIN END THEY
AREOPATHY OF MAJOR
PROPORTIONS.
SO THEY IDENTIFIED THE CAUSE
OF THE DISEASE, ITS
PATHOPHYSIOLOGY AND THEN MIKE
WENT TO ABENERON ASKING TO USE
A AD T5 ANTIBODY.
THIS IS A CHILD WHO WAS IN HIS
EARLY TEENS WHO WEIGHED
28 POUNDS.
THIS PROCEED TEEN LOSING END
THEY AREOPATHY BASED WOULD
STARVE PEOPLE TO DEATH AT AN
EARLY AGE AND THIS TEEN LOOKED
LIKE THIS AFTER TWO YEARS OF
TREATMENT WITH THE ANTIBODY.
SO IT IS RECOGNIZED EARLY IN
THE PROGRAM, ITS
PATHOPHYSIOLOGY IDENTIFIED IN
OUR PROGRAMS, TREATMENT
IDENTIFIED AND TAKEN TO FDA
APPROVAL BY AN INVESTIGATOR IN
THE INTRAMURAL PROGRAM.
SO WE WANT TO REMIND EVERYBODY
THAT WE ARE STILL ENTRUSTED IN
LYME DISEASE.
DEAMON HAS RECEIVED A --
[INDISCERNIBLE]
SO WORKING WITH OUT OF MIND
LYME DISEASE COMPLICATIONS.
WE WANT TO HIGHLIGHT THOSE
INDIVIDUALS WORKING IN THE
PROGRAM WHO HAVE COMBINED
SKIDS AND THIS PUBLICATION
HIGHLIGHTED IF YOU SCREEN FOR
THESE PATIENTS RATHER THAN
DEPENDING ON FAMILY HISTORY,
YOU GET EVEN BETTER SURVIVAL
WITH BONE MARIO TRANSPLANT --
-- MARROW TRANSPLANT OF FIVE
YEARS.
[ ARE AUDIO CUTTING OUT ]
BUT THE ANTIBODY CAUSES
THROMBONE COMPLICATIONS AND
HAS LIMITED USE.
THIS IS A PAPER THAT DESCRIBES
THE ANTIBODY THAT SEEMS NOT TO
HAVE THOSE BODIES BUT HAS
SPECTACULAR SUCCESS IN
PROMOTING SURVIVAL.
AND FINALLY WE WANT TO CALL
ATTENTION TO FDA APPROVAL ALSO
RECEIVED IN THIS CASE FOR TYPE
1 DIABETES.
THIS EFFORT BEGAN PRETTY MUCH
ENTIRELY IN 2004 AND REQUIRED
20 YEARS TO DEMONSTRATE TO THE
FDA THAT WE KNEW HOW TO PURIFY
ISLETS AND TREAT TYPE 1
DIABETES SO THIS IS THE FDA
ACKNOWLEDGEMENT THAT WE REALLY
HAVE ACHIEVED THAT END GOAL.
OKAY, THAT'S IT FOR OUR UPDATE
AND I AM HAPPY TO TAKE ANY
QUESTIONS FROM YOU.
YES?
>> HOW WILL YOU DECIDE ON THE
R01 PAY LINES WITH THESE
INCREASING POSSIBILITIES OF
8 PERCENT FOR ESTABLISHED AND
12 PERCENT FOR NEW?
BUT THAT'S ONLY ON THE WORST
CASE SCENARIO IN TERMS OF THE
OCTOBER BUDGET OR PLANNING
AHEAD OR EVEN IN THE
POSSIBILITY OF A FLAT BUDGET,
ONE THING THAT WOULD BE ON THE
CUTTING BLOCK WOULD BE THOSE
PAY LINES.
>> USUALLY WE GO WITH OUR
INTERIM PAY LINE TILL WE KNOW
WHAT KIND OF BUDGET WE ARE
GOING TO HAVE.
THAT COULD BE DECEMBER,
SOMETIMES LATER THAN THAT BUT
ONCE WE KNOW WHAT OUR BUDGET
SITUATION IS AND WITH THAT WE
WOULD KNOW HOW MANY
APPLICATIONS HAVE COME IN, WE
COULD GO AHEAD AND RECALCULATE
WHAT WILL BE CONTINUED TO US
THROUGHOUT THE YEAR WHICH GOES
RETROSPECTIVELY TO EVERYBODY
WHO HAS ACHIEVED THAT
PERCENTILE SO IT IS JUST A
CALCULATION WE MAKE WHEN WE
GET REAL NUMBERS WE CAN RELY
ON.
NO MORE QUESTIONS?
THEN LET ME INTRODUCE NED
PIERSON WHO WILL DISCUSS THE
VACCINE RESEARCH CENTER.
THANK YOU.
>>> GOOD MORNING EVERYONE, I
AM IN CHARGE OF THE CENTER AND
PLEASED TO BE WITH YOU TO
DISCUSS THE CENTER FROM JUST A
YEAR AGO.
SO IT IS A STRUCTURE THAT
MAKES DISCOVERIES THAT SUPPORT
VACCINES AND BIOLOGICS THAT
AFFECT GLOBAL HEALTH
IMPORTANCE.
GOING TO VIRUSES, VIRUSES CAN
BE CATEGORIZED AND GROUPED
REALLY BY THE MACHINES THAT
THEY USE TO CENTER CELLS SO
THEY HAVE VIRTUALLY OCCLUDED
PROTEINS THAT SHARE STRUCTURE
AND FUNCTION AND CONSIDERING
HOW A VIRUS INTRACELL WORKS,
THESE ARE REALLY THE TARGET OF
DISCOVERING THE ANTIBODIES SO
THERE ARE A NUMBER OF
STRATEGIES THAT MAY BE USEFUL
ACROSS VIRUSES WITHIN ANY
GIVEN GROUP.
NOW THE VRC WAS FOUNDED IN
1997 AND CERTAINLY BEFORE
COVID, THE PROTEIN WAS THE
MOST HIGHLY CHARACTERIZED OF
WHAT IS CALLED THE CLASS 1
FUSION PROGRAM AND THE INSIGHT
INTO UNDERSTANDING HOW THE
FUSION 1 PROTEINS WORK UNDER
STRUCTURE HAS FUELED A LOT OF
THE PROGRESS OF B -- VRC HAS
DONE OVER THE YEARS, KEG
DECADES AND REALLY IS BOILS
DOWN TO SOLVING THE STRUCTURE
AND YOU USE THIS INFORMATION
TO CREATE PROBES THAT WILL
ALLOW YOU TO IDENTIFY HUMAN
ANTIBODIES WITH THE DESIRABLE
CHARACTERISTICS, YOU PULL OUT
THOSE ANTIBODIES AND THEN USE
THOSE ANTIBODIES AS A GUIDE TO
STABILIZE THESE PROTEINS TO
MAIM IMDEFENSE -- IMMUGENS.
SO I WANT TO EMPHASIZE THE
CONCEPT HAS IMPROVED
CONSIDERABLY BEYOND HIV TO
OTHER PROTEINS, SUCH AS RSV,
INFLUENZA AS WELL AS CONE IN A
VIRUSES.
IT HAS EXPANDED BEYOND THE
STUDY OF CLASS 1 FUSION
PROTEINS INCLUDING VIRUSES
USING DIFFERENT STRATEGIES,
USING CLASS 2 FUSIONS PROTEINS
AND CELLS WITH A DISTINCT
MECHANISM INCLUDINGENTERO
VIRUSES AND NORO VIRUSES AND
WHERE WE CAN WE APPLY THE SAME
STRATEGY OF DESIGN TO APPROACH
ANTIBODY DISCOVERY AND VACCINE
DEVELOPMENT.
I WILL SHARE NOW TODAY THE VRC
CONDUCTS RESEARCH ON THE TEN
VIRAL FAMILIES THAT ARE
PRIORITIZED BY THE PATHOGEN
PLAN THAT WAS INVITED IN THE
PLAN.
BUT VRC DOES A WILL THE MORE
THAN JUST VIROLOGY.
WE WORK ON TB AND MALARIA AS
MENTIONED.
A GREAT INTEREST IN ANTICANCER
T SHELLS USING NANOPARTICLE
VACCINES THAT INCLUDE CANCER
PEPTIDES AND AGONANTS.
THE CENTER HAS QUITE A FEW
PROGRAMS THAT TOUCH ON
FUNDAMENTAL PRINCIPLES AND
THERE IS A LOT OF DEVELOPMENT
THAT ALLOW US TO APPROACH
VACCINE FORMS AND ANTIBODY
DISCOVERIES.
SO BEFORE I GET INTO ADVANCES
OF OUR DISCOVERY SCIENCE, I
WOULD LIKE TO STOP FOR A FEW
MENTION AND INTRODUCE YOU TO
THE VRC CAPABILITIES.
BUILDING 40 IS WHERE A LOT OF
THESE DISCOVERY-BASED RESEARCH
OF THE VRC IS CONDUCTED, BOTH
BASIC SCIENCE AND
TRANSLATIONALLY FOCUSED
PROBLEMS.
SOME OF THOSE DISCOVERIES
RESULTS IN CONCEPTS THAT MAY
BE DEVELOPED AS PRODUCTS.
THAT PRODUCT DEVELOPMENT IS
DONE BY THE VACCINE PRO
PRODUCTION LABORATORY IN
GAITHERSBURG BY INVESTIGATORS
WHO HAVE A UNIQUE SKILLS SET
FOR THAT TYPE OF WORK.
THE PRODUCT INVOLVING
MANUFACTURING, PILOT PLAN,
THAT IS UP IN MARYLAND.
THIS ENABLES THE HUMAN
CLINICAL TRIALS PROGRAM IN
COLLABORATION WITH OUR
PARTNERS AT NIAID.
THE VACCINE IMMUNOLOGY PROGRAM
OR VIP IS THE GROUP WITHIN PRC
THEN CHARGED WITH
CHARACTERIZING AND ANALYZING
THE OUTPUT OF THOSE CLINICAL
TRIALS USING QUALIFIED EVENTS.
I WANT TO SHOW YOU THE SLIDE
OF THE TEAM THAT DOES THIS
WORK MAKING THE CONTRIBUTION
BOTH IN BUILDING 40, BUILDING
10 UP IN GAITHERSBURG WHERE
THEY ARE LOCATED.
SO INTRODUCED VRC'S PRODUCT
DEVELOPMENT CAPABILITIES IN
THIS CIRCLE, THE LIMITATION OF
THIS DEPICTION WILL SUGGEST
YOU DO ONE THING, THEN HAND IT
OFF TO THE NEXT GROUP IN THE
VRC AND SO ON AND SO FORTH BUT
THIS HELPS YOU UNDERSTAND HOW
THE VRC IS CONNECTED AND IT IS
THESE CONNECTIONS THAT IS
REQUIRED FOR SUCCESS IN
PRODUCT DEVELOPMENT.
THESE CONNECTIONS FORM BEFORE
THE VRC DECIDES TO TRANSLATE A
DISCOVERY IN THE LAB INTO THE
PRODUCT DEVELOPMENT PROGRAM
AND THEY EXIST ALL THE WAY
THROUGH THE END OF A CLINICAL
TRIAL ANALYSIS WITH THAT WORK.
SO THIS IS CRITICAL FOR OUR
MISSION.
SO THE LAST FOUR MONTHS SINCE
I JOINED THE VRC, ONE OF THE
MANY THINGS I HAVE LEARNED IS
REALLY HOW HARD PRODUCT
DEVELOPMENT IS AND THAT'S THE
MANUFACTURE THAT HAS ITS OWN
STORY, HAS ITS OWN SCIENTIFIC
PROBLEMS YOU HAVE TO SOLVE.
SO THE SCIENTIFIC PROBLEMS OF
THE VACCINE AND PPO ARE A
CRITICAL PART OF GETTING OUR
MISSION POLITIC ACCOMPLISHED
BECAUSE THEY ARE CHANGED WITH
THESE PROBLEMS.
THIS IS A MULTIDISCIPLINARY
TEAM OF INVESTIGATORS THAT
WORK IN THIS SPACE AND I HAVE
DEPICTED HERE PAPERS IN --
PUBLISHED IN THE LAST YEAR
THAT DESCRIBE SOLVING PROBLEMS
TO MAKE FUTURE MANUFACTURING
RELATED THINGS WORK MORE
EXCLUSIVELY.
AND YOU KNOW THESE ARE NOT
PERHAPS DEPENDING ON HOW YOU
MEASURE THE HIGHEST IMPACT
PAPERS THAT THE VRC HAS
PUBLISHED IN THE LAST YEAR BUT
THEY ARE NO LESS IMPORTANT AND
I WANT TO TAKE JUST THIS
MOMENT TO HIGHLIGHT THIS WORK
AND THE TEAM THAT DOES THIS
CRITICAL PART OF THE MISSION.
SO NEXT I WILL DISCUSS A
COUPLE OF OTHER THINGS AT THE
H VRC.
THIS APPROACH IS GROUNDED ON
STRUCTURAL VIROLOGY THAT WAS
LED INITIALLY BY PETER QUONG
AS MENTIONED, NOW A LARGE TEAM
OF STRUCTURAL BIOLOGISTS THAT
ATTRIBUTE TO A WIDE RANGE OF
PROGRAMS IN THIS DIRECTION.
THE GUIDING PRINCIPLE IS
STRUCTURAL VIROLOGY AND
LEARNING IN THIS CASE FROM THE
G21 PATRIOT TEEN, A LOT OF
THIS COMES -- PROTEIN, A LOT
OF THIS COMES FROM RECOGNIZING
THE ANTIBODIES ACTIVITY.
SO ABOUT TEN YEARS AGO OR SO,
THE QUONG LAB PUBLISHED A
PAPER IN SCIENCE THAT
DISCOVERED A HIGH GPT FUSION
WORK OF HIV AND IF YOU CREATE
A VACCINE THAT ELICITED
ANTIBODIES IN THIS SPACE, YOU
COULD MAKE A VACCINE WITH
GREAT THREAT SO WE TESTED THIS
IDEA THROUGH PRODUCT
DEVELOPMENT AND CLINICAL AND
NONCLINICAL SCIENCE BUT THE
IDEA AND WHAT WE ARE WORKING
ON HERE IS TO PRIME
INDIVIDUALS WITH FUSION
PEPTIDES AS A CONJUGANT AND
BOOST WITH PRIMERS THAT HAVE
BEEN STABILIZED USING
STRUCTURAL INGENUITY AND THE
FINDING OF THIS IS THERE WAS A
RESPONSE OF OBTAINING
ANTIBODIES AGAINST THE
PEPTIDES THAT ARE THE THREAT
BUT IT IS A SIGNIFICANT
FINDING IN THIS SPACE.
AND IT IS HARD BUT WE'RE
DISCOVERING WHAT ARE THE
ANDOGENS, AND OTHER PARTS OF
THIS.
BUT RECOGNIZING THE PROBLEMS
WE SOLVE HERE, OF COURSE THE
QUONG GROUP AS WELL AS THE
CHAIN CALL TRIALS TEAM, THIS
BIG NETWORK I DESCRIBED ON
THAT VERY COMPLEX SLIDE A FEW
MOMENTS AGO.
IN THIS STUDY WHAT WE
DISCOVERED IS NONCLINICAL AS
WELL AS THE CLINICAL STUDY
REVEALED WHEN YOU IMMUNIZE
HUMANS WITH THE RESPONSE THE
PA*PBLT OGEN FINDS THE
PARTICLE YOU DIDN'T WANT TO
LOOK AT.
AND IN GRAY THERE IS THE FACE
OF THE PRIMER THAT OTHERWISE
WOULD BE IN CONTACT WITH THE
MEMBRANE.
THE IMMUNE SYSTEM DOESN'T
NORMALLY SEE THIS.
THIS IS NOW A IMMUNE -- IMMUNO
ANTIDOTE AND THAT INTRODUCES
ANOTHER PROBLEM AND ANOTHER
SET OF THINGS THAT WE CAN DO
SO WHAT THE VRC IS TRYING TO
DO IS DEVELOP A SERIES OF
STRATEGIES TO HIDE THAT BASE
OF PRIMERS FROM THE IMMUNE
RESPONSE AND SOME OF OUR
PROGRESS IS SHOWN HERE ON THE
PAPER ON THE RIGHT SO WE CAN
DO THAT AND NOW ARE EVALUATING
HOW THOSE IMMUNOGENS WORK IN A
NONCLINICAL PROCESS.
BUT I WILL STATE THERE IS
EVIDENCE THAT THE STRATEGY OF
PRIMING WITH PRIME -- FUSION
PEPTIDE CONJUGANTS WILL RESULT
IN FINDING ANTIBODIES AND IN
THE PAPER, IT DESCRIBES
IMMUNIZATION WITH JUST PRIMER
IMMUNOGENS AND LOOKING WITHIN
THE BODIES DESPITE THE
ANTIBODIES AND DISCOVERING
FUSION' HIS
>> -- ELICITED BY THE PRIMER
SO THAT IS A LOT BUT WE ARE
INTERESTED IN PURSUING THIS
EXPERIMENTAL MEDICINE, I
GUESS.
ANOTHER AREA THAT IS
CRITICALLY IMPORTANT FOR
HIV -- EXCUSE ME FOR VRC AND
HIV ANTIBODIES, MANY YEARS AGO
THERE WAS A PROVING BOARD
STUDY FOR THE DISEASE IN
INDIVIDUALS THAT WOULD PROVIDE
CONSIDERABLE DEGREE OF
PROTECTION IN HUMANS AND THIS
SORT OF GIVES US THE MARK TO
HIT.
THE MARK TO HIT WOULD BE BELOW
THE DOTTED LINE IN TERMS OF
POTENCY AND THE IDEA IS SINGLE
ANTIBODIES OR A COMBINATION OF
ANTIBODIES THAT GETS YOU BELOW
THAT LINE COULD BE OF VALUE
AND WE'RE WORKING CLOSELY WITH
DADE'S NETWORKS TO TEST THIS
IDEA BUT WE'RE ALSO HEAVILY
INVESTED IN DISCOVERY SCIENCE
TO IDENTIFY TWO TYPES OF
ANTIBODIES TO DEVELOP TOOLS TO
UNDERSTAND HOW BEST TO MEASURE
THEIR ACTIVITY IN NONCLINICAL
MODELS AND THEN TO IMPROVE
EXISTING ANTIBODIES TO EITHER
MAKE THEM MORE POTENT OR TO
TWEPBT THEM IN -- TO PRESENT
THEM IN WAYS THAT WOULD
INCREASE THEIR FUNCTIONALITY
MENTIONED IN Dr.
AUCHINCLOSS' REMARKS.
SO THE ANTIBODIES AND HI CURE,
THE CB TEST RESTING WITH HIV
CELLS.
THE RESERVOIR IS VERY SMALL
AND THERE IS NO DISTINCT
FEATURE BETWEEN A T-CELL AND
ANOTHER SO THIS IS PUBLISHED
IN A PAPER WHERE THEY
DEVELOPED THE TECHNIQUE THAT
ALLOWS THEM TO --
[ AUDIO CUTTING OUT ]
-- THAT SORTS THEM IN HI DNA
IN THIS POCKET OF ELSE AND
THEY DO TRANSCRIPTIONAL
ANALYSIS OF WHAT IS GOING ON
IN THE CELLS AS THEY TRANSPORT
IT AND THESE STUDIES HAVE AND
WILL CONTINUE TO ILLUMINATE
THE STRUCTURE OF CELLS AND
LATENCY AND CELL SURVIVAL.
TOGETHER THESE TWO ISSUES MAY
HELP US BETTER UNDERSTAND WHAT
MAINTAINS OR ESTABLISHES
LATENCY AND INFORMED
STRATEGIES TO WAKE UP THOSE
LATENT VIRUSES AS PART OF
THOSE STRATEGIES.
SO Dr. AUCHINCLOSS COVERED
THIS WELL.
CERTAINLY AT THE VRC, THERE
WAS GREAT EXCITEMENT WATCHING
THE PATHOGEN.
BART GRAHAM WAS A CRITICALLY
IMPORTANT PART OF THE VRC
DESPITE HIS RETIREMENT AND
THIS WORK REALLY PROVIDED, I
THINK, A VERY CLEAR ACTIONABLE
STRATEGY FOR TAKING WHAT YOU
LEARN IN ONE CONTEXT WHICH WAS
STABILIZING HIV IN THE RIGHT
CONFIRMATION AND APPLYING IT
TO STABILIZING THE APPROPRIATE
CONFIRMATION OF RSV.
THAT WAS THEN THE SAME
STRATEGY THAT HE AND HIS TEAM
USED FOR COVID.
SO YOU WILL SEE THIS TEAM WITH
OTHER THINGS THAT WE DO AT THE
VRC, AND HAVE ALREADY.
BUT IN ADDITION TO THE
STRUCTURAL BASED ELEMENTS OF
THIS, WE CONTINUE TO STUDY HOW
IT WORKS AND THIS VERY NICE
STUDY BY TRACY, WHAT HE HAS
DONE IS DEMONSTRATE THE
PREFUSION STABILIZED VACCINE
DO INDEED GENERATE A SUPERIOR
YOUR B CELL AND ANTIBODY
RESPONSE THAT IS ASSOCIATED
WITH NEUTRALIZATION AND
PROTECTION AND THESE
IMMUNOLODGIC CORRELATES ARE
VERY IMPORTANT BECAUSE THEY
INFORM THE NEXT SET OF
PROBLEMS THAT WE'RE WORKING
ON.
AND EXAMPLES OF THOSE PROGRAMS
INCLUDE A MIX OF VIRUSES SUCH
AS PIB1-4, NEPA VIRUS, AND WE
HAVE DESIGNS FIRST AND IN SOME
CASE SECOND GENERATIONS
DESIGNS IN THOSE APPLICATIONS
TO TRY AND ADDRESS A LARGER
AND LARGER FRACTIONION OF
STKHAELS HAVE THESE SYSTEMS.
SO MAKING COMMENTS ABOUT FLU,
THE VRC IS HEAVILY VESTED IN
MAKING A SUPERIOR MORE BROADLY
ACCEPTED VACCINE FOR FLU.
THE PORTFOLIO FOCUS ON TWO
DIFFERENT TYPES OF THE
APPROACHES.
THE FIRST IS A FERRITIN
NANOPARTICLE AND THAT ALLOWS
YOU TO PRESENT THE HH PRIMERS.
AND THIS PROGRAM HAS BEEN
MOVING FOR SOMETIME AS YOU CAN
SEE IN THE SLIDE AND THESE
MOLECULES, MANY OF THEM HAVE
BEEN MANUFACTURED AND WE ARE
NOW LEARNING ABOUT THE
ACTIVITY OF THOSE WE'RE VERY
EXCITED THAT WE WERE ABLE TO
PARTICIPATE IN THE PROGRAM AND
ONE OF THOSE WERE IN A
CLINICAL TRIAL TODAY AND THE
SUBUNIT DELIVERED BY RNA SO
THAT IS LEADING TO THE
FINDINGS WE HAVE TODAY.
SO THIS IS PROJECT, THE INNER
CORE AND YOU PASS ON THE
MOLECULES.
THERE ARE TWO VERSIONS OF THAT
WE HAVE MADE.
THERE ARE OTHER IDEAS THAT ARE
IN PROGRESS THAT WOULD ALLOW
YOU TO MAKE MULTIVAILANT
VACCINES AND AS WAS MENTIONED,
OUR PV2 IS NOW IN CLINIC.
I WANT TO SHOW YOU THIS
BECAUSE THIS IS WHAT THE
SCIENCE LOOKS LIKE.
THIS IS A INTERESTING SET OF
EXPERIMENTS AND FIRST ON THE
LEFT YOU CAN SEE THE STRATEGY
REQUIRED TO MANUFACTURE FIVE
THINGS TO INCLUDE MASB1 AND
TPWHARS THE VACCINE --
UNDERSTAND HOW THE VACCINE
LOOKS LIKE AND WHAT THE IMMUNE
RESPONSES ARE FOR WHAT YOU
MANUFACTURED.
AND WHAT IS THE TECHNOLOGY AND
THIS WILL HELP US UNDERSTAND
HOW THE MANUFACTURING
TECHNOLOGIES WORK WITH A
DIFFERENT LEVEL OF PRECISION
BUT ALSO PROVIDE INTERESTING
WAYS TO CORRELATE VACCINE
RESPONSES AND THE FORMAT AND
COMPOSITION.
THE PAST YEAR, WE HAD THREE
EXCITING STUDIES.
ON THE LEFT, A STUDY BY ONE
GROUP AND NHPS THAT SHOW IF
YOU TAKE A NANOPARTICLE 1
AGAINST FLU AND PUT THEM IN
THE SAME ANIMAL, YOU GET
PROTECTION AND THIS IS A BROAD
ELEMENTSMENT THAT SUPPORTS THE
CONCEPT THAT WE CAN PUT A HIV
STEM ON A NANOPARTICLE AND
PRESENT THAT IN A WAY THAT
GENERATES IMMUNE RESPONSES
THAT ARE PROTECTED.
ON THE RIGHT, TWO STUDIES THAT
CAME OUT IN THE SAME JOURNAL,
THE FIRST ON CLINICAL TRIAL
PROGRAMS ON THE VRC THAT
DEMONSTRATES A NANOPARTICLE
INJECTED IN A HUMAN IS SAFE
AND DID YOURABLE AND A SECOND
STUDY LED BY SARAH ANDREWS
GROUP AT THE VRC, WHAT HER
GROUP IS DOING IS SUBJECTING
THE ANIMAL RESPONSES TO THESE
VACCINES AND WHAT HE HAS SHOWN
IS THE IMMUNIZATION IS FOCUSED
ON TWO EPITOPES IN THE STEM, A
RED ONE AND A BLUE ONE TWO,
THIRDS UNDERLYING THE RED
EPITOPE AND ENCOURAGINGLY,
THOSE HAVE THE ABILITY TO
NEUTRALIZE MULTIPLE MEMBERS OF
THE SAME GROUP SO GROUP 1
REACTIVE ANTIBODIES.
THE ANCHOR IS JUST THE APALGUS
IMMUNOGEN IN THE VACCINE SO
YOU ARE GETTING AN INCREASED
RESOLUTION ON THE RESPONSE OF
THE VACCINE AND ENENABLED US
TO MAKE VACCINES WITH
INCREASING BREADTH.
AND THEN I WANT TO SHARE TWO
MORE VIN NETS -- VIGNETTES.
THESE ARE TWO MORE ADVISE,
CLASS 2 FUSION PROTEIN WHICH
INCLUDE THINGS LIKE CHICKEN
BOULIA AND.
[INDISCERNIBLE]
SO MANY YEARS AGO IN
COLLABORATION WITH DIR, WORKED
TO DEVELOP A CHICKEN VIRUS
INTO A VACCINE, PHASE 1
CLINICAL STUDY CONDUCTED BY
VRC AND THEN STAGE 2 AND AS
WAS MENTIONED, THE PHASE 3
CLINICAL TRIALS AND BOTH OF
THESE PHASE 3 TRIALS ARE VERY
ENCOURAGING.
THAT BLUEPRINT OF WHAT MADE A
GOOD CHICK VACCINE, THE VRC
DEVELOPED THREE DIFFERENT
VACCINES THAT ADDRESSED THREE
DIFFERENTEN -- DIFFERENT
ENCEPALYTIC VACCINES AND EACH
OF THEM CAN MAKE NEUTRALIZING
ANTIBODY VACCINES.
SO THEN MARIO ROTORS MADE A
VACCINE THAT RECRUITS
VOLUNTEERS AND FISHED OUT THE
ANTIBODIES FROM THOSE
VOLUNTEERS.
AND IN DOING THAT, YOU CAN SEE
HERE THE ANTIBODY THAT CAN
NEUTRALIZE ALL THREE VIRUSES
AND THERE IS A MOLECULE THAT
HAS VERY INTERESTING
DEVELOPMENT THAT WE'RE
CONSIDERING FURTHER.
THIS IS A VIRUS THAT DOES NOT
HAVE ENTRY MACHINERY LIKE THE
OTHER VIRUSES DESCRIBED.
THIS IS A NONENVELOPE VIRUS
LIKE POLE WROTE VIRUS AND LIKE
POLIO VIRUS, INFECTION OF
ADOLESCENTS AND CHILDREN CAN
RESULT IN A VERY DEBILITATING
PARALYTIC SYNDROME.
THE EPDEEM I DON'T GO OF THIS
IS INTERESTING, NOT FULLY
UNDERSTOOD, IT HAPPENS EVERY
YEAR AND REQUIRES A COUNTER
MEASURE.
JUST BEFORE COVID, TRACY,
BARNEY AND OTHERS AT VRC BEGAN
THINKING ABOUT HOW TO DEAL
WITH THIS.
DEVELOPED A STRAT DETO TAKE
FOUR PIECES AND MAKE A
PARTICLE IN THE LAB THAT LOOKS
STRUCTURALLY LIKE THE VIRUS
AND DEMONSTRATES THIS PARTICLE
IMMUNOGEN IS PROTECTED IN
MULTIPLE CLINICAL MODELS AND
THE VRC IS NOW WORKING ON
STRATEGIES TO MANUFACTURE THIS
FOR A HUMAN STUDY.
AND I WANT TO END WITH MALARIA
JUST TO EMPHASIZE WHAT Dr.
AUCHINCLOSS MENTIONED IS WE
HAVE VERY EXCITING SERIES OF
DISCOVERIES RELATING TO THE
ANTIBODIES WITH THE PROTEIN
AND THESE ARE PROTECTIVE IN
HUMANS.
THESE WERE CHALLENGED IN THE
FIELD OF DIR.
WE'RE VERY VESTED IN THIS
PROGRAM.
THIS INCLUDES, YOU KNOW, WE'RE
CONTINUING TO TRY AND OPTIMIZE
THESE MOLECULES FOR GREATER
POTENCY WHICH WOULD TRANSLATE
INTO THESE GOODS.
THESE TWO POINTS RELATE TO THE
CHALLENGES AND THEY ARE
SIGNIFICANT IN IDENTIFYING
COMMERCIAL PARTNERS THAT WILL
HELP US GET THIS TO THE FIELD.
AND THERE IS CLINICAL
EVALUATION ONGOING WITH PETE
CROMPTON'S GROUP.
THIS IS VERY EXCITING WITH THE
NIH WITH A GREAT INTRAMURAL
PROGRAM RECOGNIZED BY A NUMBER
OF GROUPS.
SO JUST A FEW QUICK COMMENTS
ABOUT THE VRC.
I GUESS THE MOST DRAMATIC
THING THAT OCCURRED SINCE RICK
KALB PRESENTED THE COUNCIL
LAST FALL IS THE DIRECTOR IN
APRIL, VERY EXCITED TO BE AT
THE VRC AND CONTRIBUTE TO ITS
SCIENCE.
KOUP.
AND EXCITED TO SHOW YOU THIS
SCIENCE TODAY AND EXCITED TO
TACKLE WHAT THE VRC WILL WORK
ON TOMORROW WHICH IS A VERY
COLLABORATIVE INCREDIBLE GROUP
OF FOLKS AT VRC.
WE HAVE HAD OTHER DEPARTURES
AS WELL, ADRIAN MCDERMOTT
GOING TO JOIN SAM OFI AS
GLOBAL HEAD OF IMMUNOLOGY,
NANCY SULLIVAN DEPARTED TO
JOIN BOSTON UNIVERSITY AS
DIRECTOR OF NATIONAL EMERGING
INFECTION DISEASES AND RUTH
WOODWARD WHO DEPARTED AS A
VETERINARIAN.
SO THE NEXT FEW MONTHS, GATHER
YOUR TEAM AND START THINKING
ABOUT WHAT ARE THE NEXT REAL
PROBLEMS TO SOLVE AND WE DID
THAT IN EARLY MAY TO TALK
ABOUT THE KIND OF SCIENCE AND
KIND OF PROGRAMS WE NEED TO
INVEST AND REINVEST IN.
ABOUT A MONTH LATER, I POSTED
A RETREAT -- HOST A*ED RETREAT
FOR -- HOSTED A RETREAT FOR
THE VRC.
THIS WAS AN OPPORTUNITY TO
SHARE MY SCIENTIFIC VISION AND
APPROACHES TO ENERGY
INVESTMENT IN MENTORING AND
OUR ENVIRONMENT AT THE VRC
WHICH WAS REALLY GREAT AND
FULLY FANTASTIC TO GET THIS
GROUP OF PEOPLE IN ONE ROOM
AND FEEL THEIR ENERGY.
SO NOW WE ARE ACTIVELY DOING
THE HARD WORK OF RECRUITING
NEW FACULTY AND NEW PROGRAM
HEADS TO EXECUTE THOSE PLANS
AND I WILL REPORT ON THAT NEXT
TIME I HAVE THE CHANCE TO BE
HERE SO THANK YOU.
>> ARE THERE ANY QUESTIONS?
>> THAT WAS A REALLY LOVELY
TALK AND REALLY FUN TO SEE THE
PRODUCT DEVELOPMENT WORK IN
JUST THE AMOUNT OF CAPACITY
THAT EXISTS IN HOUSE AT THE
VRC AND THROUGH ALL THE
PHASES.
THE QUESTION IS GO OVER HOW
YOU INTERACT WITH THE PRIVATE
SECTOR WHEN IT COMES TO REALLY
BRINGING THESE THINGS FORWARD,
BOTH BRINGING THE PRODUCTS
THERE AND THEN PROTECTING THE
INVESTMENTS AMERICAN PEOPLE
HAVE MADE IN THIS PROGRAM.
>> YEAH, I WILL CONFESS RIGHT
AT THE FRONT THIS IS A GROWTH
AREA FOR ME AS A SCIENTIST
COMINGS INTO THIS VERY COCK
PLEX ROLE.
I WILL SHARE THAT THIS IS A
CHALLENGE SO A LOT OF THE
ACTIVITIES THAT HAVE RESULTED
IN THE VRC PRODUCTS ARE REALLY
COLLABORATIVE EXERCISES THAT
BEGAN REALLY BEFORE WITH THE
PRODUCT WHERE WE, THE VRC AND
THE PRIVATE SECTOR HAS SHARED
SCIENTIFIC INTEREST TO WORK
TOGETHER ON WHAT BECAME A
PRODUCT, VRC WOULD BE AN
EXAMPLE OF THAT.
SOME OF THE PRODUCTS THAT
EXIST ARE LICENSURE ACTIVITIES
THAT OCCURRED AFTER THE
SCIENCE WAS DONE AND THE
INTELLECTUAL PROPERTIES HERE
>>TO REENGAGE AND EXPLORING
WHAT POTENTIAL COLLABORATE
PREPARES FOUR FOR ALL OF OUR
PORTFOLIO, WHAT SCIENTIFIC
INTERESTS WE SHARE TO SEE
WHERE WE CAN WORK TOGETHER.
THIS HAS BEEN AN INTERESTING
AND ENJOYABLE OPPORTUNITY IN
THE LAST FOUR MONTHS TO MEET A
LOT OF NEW PEOPLE WHO BRING
OPERATIONAL CAPABILITIES TO
NIAID AND THE SCIENCE WE DO.
BUT I WOULD SAY THIS IS
DIFFICULT AND THERE IS NO
BETTER EXAMPLE THAN BRINGING
FORWARD SOMETHING AS EXCITING
AS AN BODY THAT WILL PROTECT
PEOPLE FROM MALARIA AND WE
JUST NEED TO GET ACROSS THAT
GAP OF AMAZING SCIENCE,
AMAZING CLINICAL DATA.
AND PARTNER IN LICENSING AND
MANUFACTURING MATERIAL THAT
COULD BE USED.
>>GREAT TALK AND JUST TO
FOLLOW UP, YOU HAVE SO MUCH
GOING ON THAT THE ANSWER OF
HOW TO INTERACT WITH
INDUSTRIES JUST NEEDS, I
THINK, SOME SORT OF NEW IDEA
BECAUSE IT IS TOO BIG TO DO
ONE AT A TIME.
WE HAVE ABOUT TEN PROGRAMS,
ALL OF WHICH HAVE THE
POSSIBILITY OF REALLY MOVING
THE NEEDLE FOR A SPECIFIC
DISEASE IN SOME PART OF THE
WORLD.
I DON'T HAVE A GOOD ANSWER.
I MEAN OBVIOUSLY I DON'T HAVE
THE ANSWER BUT IT'S, UM, LIKE
A BIG COMPANY WITH A LOT OF
PROGRAMS AND SOMEWHERE IN THE
NIH NEEDS TO HIRE OR BRING IN
PEOPLE WHO CAN MAKE THE
TRANSITION INTO GETTING A
PRODUCT OUT MORE EFFICIENT
THAN ONE AT A TIME AND WAITING
FOR PEOPLE TO KNOCK AT YOUR
DOOR.
>>THANKS FOR THE COMMENT.
THANKS FOR THE TERRIFIC
OVERVIEW OF PROGRESS IN SO
MANY DIFFERENT AREAS.
IN THE AREA OF RSV, YOU KNOW,
IT SEEMS LIKE WE'RE MOVING
FROM A TIME WHEN THERE WERE NO
VACCINES OR INTERVENTIONS TO
ONE WHERE YOU HAVE AT LEAST
THREE CHOICES WITH PREMATE
TALL.
POST NATAL AND POST NATIVE
ACTIVE AND PERHAPS MOVING INTO
A GROUP OF STUDIES OF
IMPLEMENTATION, YOU KNOW, WHAT
IS GOING TO BE THE BEST
STRATEGY FOR PREVENTING
DISEASE AND IT WILL VARY BY
INDIVIDUAL PATIENT, AGE,
WHATEVER, YOU HAVE ANY INSIGHT
AS TO THIS NEXT PHASE AND HOW
THOSE SORTS OF ISSUES WILL BE
SORTED OUT?
>>THAT IS A BIT BEYOND MY
EXPERTISE.
THAT IS NOT SOMETHING WE'RE
ENGAGED IN, THE COMPARISON OF
PRODUCTS AND HOW THEY MIGHT BE
BEST USED CLINICALLY.
>>SO VERY STIMULATING.
OBVIOUSLY YOUR FOCUS IS MOSTLY
ON VIRUSES BUT PLEASED TO SEE
THE MALARIA AND JUST WONDERING
IF THERE ARE CONSIDERATIONS
FOR THIS APPROACH OF
DISCUSSION FOR US ON NONVIRAL
INTRACELLULAR PATHOGENS AND
WHETHER THE STRUCTURE BASED
GUIDED APPROACH HAS INCREASED
COMPLEXITY BECAUSE MAYBE
THERE'S MULTIPLE INJURY
MECHANISMS AND THINGS LIKE
THAT.
AND SECOND AND MAYBE A MORE
COMPLEX QUESTION IS THERE
POTENTIAL FOR APPROACH FOR
POST INFECTION VACCINE
DEVELOPMENT?
>>SO THE FIRST PART IS THE
PROGRAMS AT CRC, AND THIS IS A
PROBLEM TO BE SOLVED, REFLECTS
A BIT OF STRATEGIC THINKING
ABOUT WHERE THERE IS A NEED SO
WE SOLVE THE MOST IMPORTANT
PROBLEM OF COURSE AND INTEREST
AND EXPERTISE OF PRINCIPLE
INVESTIGATORS THAT WILL DO THE
WORK AND SOLVE THE PROBLEMS.
AND TO GIVE YOU A SENSE OF WHY
WE'RE DOING SOME OF THE THINGS
WE'RE DOING, THAT'S REFLECTED
IN THE PORTFOLIO.
IN TERMS OF STRATEGIES FOR --
THERAPEUTIC OR POST EXPOSURE
STRATEGIES, YOU KNOW, I THINK
ANTIBODIES ARE REALLY
EXCITING.
I STUDY ANTIBODIES IN THE
CONTEXT OF THE WORK THAT WE
DO.
I THINK ANTIBODIES HAS GREAT
POTENTIAL FOR SOME
APPLICATIONS AND THEN WHEN THE
PATIENTS OR OTHERS ARE GIVEN
IT, JUST DEPENDS ON THE
COMPLEXITY OF THE BUG YOU ARE
TRYING TO WORK ON, THE VIRUSES
OF WHICH MALARIA IS A BIG
ISSUE.
SO I THINK IT DEPENDS ON THE
TARGET AND WHAT OUR THINKING
IS BASED ON PURELY PREVENTION
OR SOMETHING THAT COULD WORK
THERAPEUTICALLY.
>>ALSO LOVE THE WORK OF THE
PASSIVE ADMINISTRATION OF
ANTIBODIES FOR SO MANY
APPLICATIONS AND I WONDER TO
WHAT DEGREE WE HAVE HAD A
TRIAL RUN OF THAT WITH THE
COVID PANDEMIC AND OF COURSE A
RELATIVELY SHORT HALF LIFE,
THINGS LIKE HIV, AIDS, WHAT
LESSONS YOU HAVE LEARNED FROM
THAT EXPERIENCE.
>>AS YOU SAID, IT REALLY
DEPENDS ON THE BIOLOGY AND
PRODUCT DEVELOPMENT AND
PERHAPS REFLECTS SOME
AWARENESS OF HOW THE VIRUS
WORKS WITH LIMITATIONS.
SO COVID, THE CHALLENGE IS
VARIATION AND THEREFORE YOU
HAVE TO HAVE MOLECULES THAT
EITHER ACCOMMODATE THE KNOWN
VARIATION OR TARGET SITES THAT
ARE NOT LIKELY TO VARY AT ALL.
THERE ARE CERTAINLY SOME
VIRUSES THAT FOR WHICH THIS IS
FAR LESS OF AN ISSUE.
THAT WOULD BE, I WOULD SAY,
EASIER TARGETS OF OPPORTUNITY
BUT STILL MAY HAVE PUBLIC
HEALTH IMPACTS TO ADDRESS.
WE CAN'T CHANGE THE VARIATION
OF THE VICE SO WE HAVE TO
EITHER FIND BETTER APTY BODIES
WITH GREATER BREADTH AND WE'RE
TRYING OR COMPLIMENT THAT WITH
MOLECULES THAT DO MULTIPLE
THINGS IN ONE SUCH AS.
>>I MUST ASK IS ANYONE AT THE
VRC LOOKING AT AGE RELATED
INFOCYTES AND HOW IT AFFECTS
TIDERS ON MEMORY?
>>NOT AT THIS TIME, NO.
>>THERE ARE NEW ANTIBODIES
THAT ARE ABLE TO PREDICT
BINDING AND NEW INDICATION
ALGORITHMS THAT YOU ARE ABLE
TO GET FAIRLY ACCURATE TYPING
OFF GWAS DATA SO IT MAY BE
OPENING THE FIELD TO LOOK AT
VACCINES' VARIABILITY BETWEEN
INDIVIDUALS AND THEIR TYPES
AND ABILITY TO PRESENT THE
ACTUAL PROTEINS.
>>YEAH, THANKS FOR THE
COMMENT, THAT IS VERY
INTERESTING.
>>THANK YOU VERY MUCH,
APPRECIATE IT.
>>THANK YOU.
>>BEFORE, BEFORE WE ADJOURN
FROM THIS OPEN SESSION, I JUST
WANT TO REMIND EVERYBODY THAT
THE ADVISORY COUNCIL MEETING
IN JANUARY HAS BEEN MOVED FROM
MONDAY JANUARY 29TH TO TUESDAY
JANUARY 30TH.
THAT WILL BE A VIRTUAL
MEETING.
WE DECIDED EVEN BEFORE THE
PANDEMIC THAT THE JANUARY
COUNCIL MEETING WILL ALWAYS BE
VIRTUAL JUST TO MAKE TRAVEL
EASIER.
I DID MENTION IN MY OPENING
REMARKS THAT JENNY MURRATTA'S
RIFLE HERE IN A FEW WEEKS
TAKING OVER AS DIRECTOR OF
NIAID WOULD START THE CLOCK
FOR ME.
I OFTEN SAID I WOULD OFFER SIX
MONTHS TO THE NEW DIRECTOR FOR
TRANSITION AND THAT WOULD BE
END OF MARCH NEXT YEAR TO STEP
DOWN FROM THIS POSITION.
SO THIS WILL BE THE LAST
IN-PERSON MEETING WITH THE
COUNCIL SINCE IT WILL BE
VIRTUAL IN JANUARY.
IT IS A PLEASURE TO WORK WITH
COUNCIL OVER THE COURSE OF
ALMOST 18 YEARS NOW.
THE MEETING WILL BE ADJOURNED
AND WE WILL GO TO CLOSED
SESSION IN ABOUT FIVE MINUTES.
WE ASK NONU.S. GOVERNMENT
PEOPLE TO PLEASE STEP OUT OF
THE ROOM WHILE WE'RE DOING
THAT.
THE FOUR PEOPLE RETIRING FROM
COUNCIL, COULD YOU MEET WITH
ME TO HAVE YOUR PICTURE TAKEN
AND RECEIVE YOUR PLAQUES
BECAUSE WE WANT TO HONOR YOUR
SERVICE.
SO THANK YOU VERY MUCH.
ADJOURNED.