>>WELCOME TO THE OPEN
SESSION OF THE 202nd MEETING
OF THE ALLERGY AND INSPECTION
ANXIOUS DISEASE.
AS YOU KNOW, DURING THE OPEN
SESSIONS WE'RE JOINED FROM
PROFESSIONAL AND LAY
ORGANIZATION WHO'S SHARE
INTEREST AND ACTIVITIES IN
COMMON WITH THE MISSION OF THE
INSTITUTE.
WE WELCOME THEM, AS ALWAYS, AND
I'D LIKE TO ALSO WELCOME TWO AD
HOC DAIT COUNCIL MEMBERS WHO ARE
JOINING US TODAY.
Dr. DAVID ARTIST IS THE
MICHAEL KORS PROFESS OF
IMMUNOLOGY IN THE DEPARTMENT OF
MEDICINE WITH THE CORNELL
MEDICAL COLLEGE AND Dr. DEB
ROSS KEY HERMIGHT FR IMMUNEEL GE
AND PATHO BIOLOGY.
WE ARE DELIGHTED TO HAVE THESE
TWO AD HOC MEMBERS WITH US
TODAY.
COUNCIL MEMBERS Dr. LINDA
BAKKENSTED IS UNABLE TO BE WITH
US TODAY.
WITH REGARD TO THE MINUTES, THE
FIRST ITEM OF BUSINESS IS TO
REVIEW AND APPROVE THE MINUTES
FROM THE LAST MEETING.
YOU SHOULD ALREADY HAVE SEEN A
COPY OF THE MINUTES IN THE
ELECTRONIC COUNCIL BOOK.
ARE THERE ANY CORRECTIONS TO THE
MINUTES?
DOES ANYONE HAVE ANY QUESTIONS
OR CONCERNS ABOUT THE CONCEPTS
PRESENTED AT THE PREVIOUS
MEETING?
IF NOT, MAY I HAVE A MOTION FOR
APPROVAL?
IS THERE A SECOND?
ALL IN FAVOR OF THE MINUTES,
PLEASE A AYE.
ANY OPPOSED?
THE MINUTES STAND AS APPROVED.
NOW, LET'S GET ON WITH THE
FORMAL REMARKS TO THE COUNCIL.
PRESIDENT JOE BIDEN HAS
NOMINATED Dr. ARATI PRABHAKAR
TO SERVE AS THE DIRECTING OFF
THE OF THE WHITE HOUSE OFFICE OF
SCIENCE OF THE OSTP.
ONCE CONFIRMED TO THIS POSITION,
SHE ALSO WOULD SERVE AS
ASSISTANT TO THE PRESIDENT FOR
SCIENCE AND TECHNOLOGY AS IS
CHIEF ADVISER THE SCIENCE AND
TECHNOLOGY, SHE WOULD BE A
CABINET MEMBER.
THE SENATE CONFIRMATION PROCESS
FOR HER NOMINATION, IS CURRENTLY
UNDERWAY.
SHE, A HIGHLY RESPECTED ENGINEER
AND APPLIED PHYSICIST, SERVED IN
PREVIOUS ADMINISTRATIONS AS
DIRECTOR OF TAP ADDRESS AND
TECHNOLOGY AND THE DEFENSE
ADVANCED RESEARCH PROJECT AGENCY
OR.
THE ADMINISTRATION ANNOUNCED THE
APPOINTMENT OF THE SEASON
EMERGENCY MANAGEMENT LEADER
ROBERT FENTON UNION AS THE WHITE
HOUSE NATIONAL MONKEYPOX
COORDINATOR.
Dr. DEMETRE DASKALAKIS, A
HELPER THE CDC DIVISION OF HIV
PREVENTION WAS NAMED THE DEPUTY
COORDINATOR.
THE STRATEGIC AND OPERATIONAL
RESPONSE TO THE MONKEYPOX
OUTBREAK IS NOW BEING LED BY
THESE TWO INDIVIDUALS WITH
DECADES OF RELEVANT AND
COMPLIMENTARY EXPERIENCE, Mr.
FENTON SERVED AS ACTING FEMUR
ADMINISTRATOR AND LED MULTIPLE
CHALLENGING OPERATIONS
THROUGHOUT HIS CAREER.
PRIOR TO JOINING THE CDC, Dr.
DASKLAAKIS OVER AWE INFECTIOUS
DISEASE MANAGEMENT FOR THE
DEPARTMENT OF HEALTH AND MENTAL
HYGIENE IN NEW YORK CITY.
BOTH PLAYED CRITICAL ROLES IN
MAKING COVID-19 VACCINES MORE
ACCESSIBLE TO UNDERSERVED
COMMUNITIES.
IN JULY, FDA COMMISSIONER, Dr.
ROBERT KAYLORA ANNOUNCED THE
SELECTION OF TWO OUTSTANDING
PROFESSIONALS TO FILL IMPORTANT
SENIOR LEADERSHIP POSITIONS AT
THE AGENCY.
Dr. BUMPIS WHO SERVED AS
DIRECTOR OF THE DEPARTMENT OF
MOLECULAR SCIENCES AND
PHARMACOLOGY AT THE JOHNS
HOPKINS SCHOOL OF MEDICINE IS
THE NEW FDA CHIEF SCIENTIST.
Dr. HILARY MARSTON A
HIGHLY-VALUED COLLEAGUE, WHO
PREVIOUSLY SERVED IN MY OFFICE
AS MEDICAL OFFICER AND POLICY
ADVISER FOR GLOBAL HEALTH AND
MOST RECENTLY AS THE WHITE HOUSE
SENIOR POLICY ADVISER ON
COVID-19, IS NOW THE CHIEF
MEDICAL OFFICER AT FDA.
PRESIDENT JOE BIDEN HAS SELECTED
Dr. MONICA BERKTECHNOLI AS A
CLINICIAN AND AN EXECUTIVE AS
THE NEXT DIRECTOR IN THE FIRST
WOMAN TO LEAD THE NATIONAL
CANCER INSTITUTE.
CURRENTLY, Dr. BERT AGO
KNOWLEDGE' IS THE RICHARD E.
WILLIAM PROFESSOR OF SURGERY AT
HARVARD MEDICAL SCHOOL AND SHE
HOLD POSITIONS AT BRIGHAM.
SHE WILL TAKE OVER THE REIGNS
FROM Dr. DOUG LOWY WHO HAS
BEEN SERVING AS ACTING NIH/NCI
DIRECTOR SINCE FORMER NCI
DIRECTOR Dr. NED SHARPLESS
STEPPED DOWN LAST SPRING.
IN JUNE, ACTING NIH DIRECTOR
Dr. LARRY TABAK ANNOUNCED THE
SELECTION OF KEVIN WILLIAMS AS
THE DIRECTOR OF THE NIH OFFICE
OF EQUITY, DIVERSITY AND
INCLUSION OR EDI.
KEVIN JOINS NIH FROM THE U.S.
FEDERAL TRADE COMMISSION WHERE
HE MOST RECENTLY HELD A POSITION
OF DEPUTY EXECUTIVE DIRECTOR.
HE WILL GUIDE THE STRATEGIC
DIRECTION FOR NIH ON ALL
INCERTAINAL EDI MATTERS.
LET ME DIGRESS TO BRING YOU
UP-TO-DATE ON NIAID ACTIVITIES
IN THIS AREA.
MANY OF YOU MAY BE AWARE OF
EFFORTS ACROSS THE NIH TO
ENHANCE DIVERSITY, EQUITY,
INCLUSION AND ACCESSIBILITY OR
DEIA.
IN CARRYING OUT OUR MISSION,
NIAID IS COMMITTED TO FOSTERING
A WORKPLACE THAT EMBODIES AND
VALUES THE DIVERSE STAFF.
THE FUNDS IN EXTRA RESEARCH
PORTFOLIO INCLUSIVE OF THE
VARIOUS POPULATIONS IT SERVICE
AND THAT PRIORITIZES HEALTH
EQUITY IN ALL RESEARCH THAT
NIAID CONDUCTS AND SUPPORTS.
AS PART OF THIS COMMITMENT,
NIAID HAS ESTABLISHED AN
INTERNAL DEIA COUNCIL ADVISING
OUR LEADERSHIP ON MANY OF THESE
ACTIVITIES GOING FORWARD.
TO GATHER INFORMATION FROM AN
EXTRAMURAL COMMUNITY TO ENHANCE
DEIA ACROSS NIAID ACTIVITIES,
WE'LL BE ISSUING A REQUEST FOR
INFORMATION THIS FALL.
THE RFI IS INTENDED TO INFORM US
OF POTENTIAL APPROACHES TO
ADVANCE DEIA AND TO ENSURE THAT
ALL AVAILABLE PERSPECTIVES ARE
CONSIDERED AS NIAID DEVELOPS AND
IMPLEMENTS DEIA STRATEGIES.
WE ENCOURAGE THE EXTRAMURAL
RESEARCH COMMUNITY TO SHARE YOUR
THOUGHTS WITH US IN THIS
IMPORTANT DISCUSSION.
NOW LET ME GET BACK TO A FEW
MORE PERSONNEL UPDATES.
THE DIVISION OF EXTRAMURAL
ACTIVITIES SELECTED EILEEN LOUIS
AS A NEW BRANCH CHIEF IN THE
OFFICE OF ACQUISITIONS.
SHE WILL OVERSEE RESEARCH
CONTRACTS, BRANCH B. AND HER
EXPERIENCE HAS CONTRACT
MANAGEMENT ACQUISITION AND SPANS
MORE THAN 28 YEARS.
INITIALLY, AS A PRIVATE SECTOR
CON TRACKER TO THE OFFICE OF
NAVAL RESEARCH, SHE JOINED THE
NIAID DEA OFFICE OF ACQUISITIONS
IN 2011.
NIAID WELCOMES TWO NEW BRANCH
CHIEFS TO JOINS THE TECHNOLOGY
TRANSFER AND INTELLECTUAL
PROPERTY OFFICE.
Dr. COSSEY MAFUDA IS THE TIP
AND Dr. CHATTERJEE IS THE NEW
CHIEF OF THE BRANCH B.
COSMO SERVED AS THE DIRECTOR OF
THE OFFICE OF PARTNERSHIP AND
BUSINESS DEVELOPMENT AT THE
NATIONAL MEDICAL RESEARCH
CENTER.
PREVIOUSLY, HE WAS A PATENT AND
LICENSING CONSULTANT IN THE FDA
TECHNOLOGY TRANSFER PROGRAM AND
A PATENT IN LICENSING OFFICER AT
THE UNIVERSITY OF MARYLAND,
BALTIMORE.
Dr. CHATTERJEE CAME TO NIAID
FROM THE NCI.
HE WAS A MEMBER OF THE
LEADERSHIP TEAM AND THE
TECHNOLOGY TRANSFER CENTER AND
SERVED AS THE UNIT SUPERVISOR
FOR TECHNOLOGY TRANSFER
OPERATIONS NOT ONLY OF NCI AND
ALSO OF OTHER NIH ENTITIES.
FINALLY, WE ARE PLEASED TO
WELCOME BACK TO NIAID STEPHANIE
HIXSON, THE NEW DIRECTOR OF OUR
OFFICE OF WORKPLACE SOLUTIONS.
STEPHANIE FILLS THE POSITIONS
LEFT BY THE RETIREMENT OF JUDY
YAS KNEE LATE LAST YEAR.
STEPHANIE CAME TO NIH FROM HER
POSITION AS SENIOR DIRECTOR OF
REAL ESTATE AND CONSTRUCTION SHE
PROVIDED 15 YEARS OF DEDICATED
SERVICE TO NIH, INCLUDING,
MANAGING THE DESIGN AND
ACTIVATION OF NIAID'S ON CAMPUS
BIO CONTAINMENT RESEARCH
BUILDING AND MANAGING THE
NIAID'S BSL4 MRI IMAGING
FACILITY.
THROUGHOUT THE YEAR, NIAID HOSTS
MANY INTERNATIONAL DELEGATIONS
WITH WHICH I, AND OTHER STAFF
MEMBERS, MEET.
DURING THE LAST FEW MOVES WE
HAVE COORDINATED VIRTUAL AND
IN-PERSON MEETINGS WITH VISITORS
FROM THE UNITED ARAB EMIRATES,
GERMANY, ITALY, EUROPE, SOUTH
KOREA AND THE UNITED KINGDOM.
THIS SLIDE HIGHLIGHTS JUST A FEW
OF THESE MEETINGS.
PICTURED IN THE UPPER-LEFT OF
THE SLIDE IS PROFESSOR CHRIS
WHITTY THE CHIEF MEDICAL OFFICER
FOR ENGLAND.
WE'VE HAD SEVERAL
REGULARLY-SCHEDULED RECENT
EXCHANGES TO DISCUSS COVID-19
RESEARCH AND CHALLENGES AS WELL
AS THE MONKEYPOX OUTBREAK.
IN THE UPPER-RIGHT OF THE SLIDE,
I AM PICTURED GREETING Dr.
HANCE KLUGE THE WHO REGIONAL
DIRECTOR FOR EUROPE DURING HIS
VISIT TO WASHINGTON IN EARLY
DOUG.
HE AND I DISCUSSED COVID-19
READINESS FOR THE FALL,
MONKEYPOX AND OTHER TOPICS.
IN THE LOWER-RIGHT AREA OF THE
SLIDE, I AM PICTURED WITH A
DELEGATION OF SENIOR UAE HEALTH
OFFICIALS.
NIAID STAFF FROM OUR INTRAMURAL
PROGRAM AND THE VRC JOINED ME IN
DISCUSSING WITH THEM
COLLABORATIVE ACTIVITIES
INCLUDING A JOINT GRANT PROGRAM
THAT WE ARE CO FUNDING WITH UAE
INSTITUTIONS.
THE PHOTO IN THE LOWER-LEFT AREA
OF THE SLIDE SHOW A VIRTUAL
MEETING I ATTENDED JUNE 3
JUNE 30th WITH THE GERMAN
MINISTER OF HEALTH Dr. KARL
LAUTERBACH AND Dr. SAHIN AS
WELL AS THE WHITE HOUSE
CORONAVIRUS RESPONSE COORDINATOR
Dr. JHA TO DISCUSS THE
SCIENTIFIC EVIDENCE FOR GUIDING
VACCINES SELECTION FOR THE FALL
IMMUNIZATION CAMPAIGN.
ON JULY 8th, WE ENTERED INTO A
AGREEMENT WITH . TECHNOLOGY
COMPANY BASED IN CAPE TOWN,
SOUTH AFRICA.
THE MRNA VACCINE CENTER OF
EXCELLENCE AND TRAINING OR THE
TECHNOLOGY TRANSFER HUB PART OF
AN EFFORT LED BY W.H.O. TO BUILD
CAPACITY IN LOW AND MIDDLE
INCOME COUNTRIES TO MAKE mRNA
VACCINES.
THE MUTUALLY BENEFICIAL
COLLABORATION WILL ENABLE
SCIENTISTS AT THE NIAID/VRC AND
AFRIGEN TO SHARE KNOWLEDGE,
EXPERTISE AND DATA ON mRNA
PRODUCTION PROCESSES TO SUPPORT
THEIR RESPECTED MISSIONS FOR THE
VRC TO PRODUCE VACCINES FOR
EARLY-STAGE CLINICAL TRIALS AND
FOR AFRIGEN TO MANUFACTURE
VACCINES AT SCALE.
NOW, I WOULD LIKE TO TAKE A FEW
MINUTES TO UPDATE YOU ON THE NIH
BUDGET.
AS YOU MAY RECALL AT OUR LAST
MEETING, I UPDATED YOU ON THE
FISCAL 2023 PRESIDENT'S BUDGET
RELEASED ON MARCH 28th.
SINCE THEN, THE HOUSE AND SENATE
HAVE BOTH RELEASED DRAFT BUDGETS
FOR NIH.
THE OVER ALL PROPOSAL INCREASED
FOR NIH IN THE BOTTOM-MIDDLE OF
THE SLIDE IS 5.5% UNDER THE
HOUSE BILL, AND 6.6% ON THE
RIGHT LOWER PANEL FOR THE SENNAL
BILL WITH MOST INSTITUTES
RECEIVING AN INCREASE OF 2% ON
BOTH BILLS.
NOTABLY, THE HOUSE BILL PROPOSES
LARGER FUNDING INCREASES THAN
MOST INSTITUTES INCLUDING THE
NIAID.
THE HOUSE AND SENATE BILLS HAVE
A DIFFERENT STRATEGY FOR FUNDING
THE ADVANCED RESEARCH PROJECTS
AGENCIES FOR HEALTH OR ARPA-H.
THIS IS AN INITIATIVE CREATE
TODAY SPEED TRANSFORMATION IN
THE HEALTH RESEARCH AND THE
APPLICATION AND IMPLEMENTATION
OF HEALTH BREAKTHROUGHS.
UNDER THE HOUSE BILL, ARPA-H
WOULD RESIDE OUTSIDE OF THE NIH,
SPECIFICALLY WITHIN THE HHS
OFFICE OF THE SECRETARY WITH AN
INITIAL BUDGET OF $2.75 BILLION.
THE SENATE BILL INCORPORATES
ARPA-H WITHIN NIH WITH A BUDGET
OF $1 BILLION.
THE CONFERENCE COMMITTEE IS IN
THE PROCESS OF IRONING OUT THE
DIFFERENCES CONTAINED IN THE
HOUSE VERSUS THE SENATE BILLS
BEFORE IT SENDS THE BUDGET
PACKAGE TO THE PRESIDENT FOR HIS
SIGNATURE.
GIVEN WHERE WE ARE IN THE BUDGET
PROCESS, WE EXPECT TO BEGIN
FISCAL '23 UNDER A CONTINUING
RESOLUTION OR A CR.
THIS IS NOTHING NEW.
WE HAVE BEGUN THE FISCAL YEAR
UNDER CR EVERY FISCAL YEAR SINCE
1998.
UNTIL A FINAL FY23 BUDGET IS
PASSED, WE WILL MAINTAIN A
CONSERVATIVE POSTURE IN SETTING
PAY LINES AND PROGRAM LEVELS SO
WE MAINTAIN THE FLEXIBILITY TO
ADJUST PROGRAMS TO EFFECTIVELY
OPERATE WITHIN THE FINAL BUDGET
LEVEL WHICH WE DO NOT ME AT THIS
POINT.
THIS SLIDE SHOWS THE NIAID
FINANCIAL MANAGEMENT PLAN FOR
THE FISCAL '23 BUDGET.
OUR RO1 PAYLINES FOR ESTABLISHED
AND NEW P.I.s ARE AT THE TENTH .
COMPETING UNSOLACATED AWARDS AS
WELL AS NON COMPETING GRANTS AND
RND AWARDS WILL INCUR NEW
PROBLEMATIC ADJUSTMENTS AND
COMPETING RESEARCH INITIATIVES
HAVE BEEN CUT BY UP TO 20% TO
SUSTAINED NEW INVESTIGATOR
INITIATED AWARDS.
WE ESTIMATE THAT OVER ALL
SUCCESS RATES WILL BE 18 TO 22%
SIMILAR TO THAT OF 2022.
NOW AN IMPORTANT ASPECT OF OUR
APPROPRIATION IS TO SUMMARIZE
THE PREPORTION THAT CONGRESS HAS
EARMARKED FOR NIAID TO SPEND ON
SPECIFIC DISEASE AREAS.
WE APPRECIATE THE ADDITIONAL
FUNDING.
HOWEVER, EARMARKS LIMIT OUR
FLEXIBILITY TO SUPPORT
INVESTIGATOR-INITIATED PROJECT
AND OTHER IMPORTANT NIAID
RESEARCH PRIORITIES.
THE ATTACHED TABLE SHOWS THE
COMPONENTS OF OUR BASE AND
EARMARKED BUDGETS FROM FISCAL
2022 COMPARED TO PROPOSES IN THE
HOUSE AND SENATE BILLS FOR
FISCAL '23.
BOTH THE HOUSE AND SENATE BILLS
PROPOSE INCREASING THE EARMARKS
ALLOCATIONS FOR ANTIMICROBIAL
RESISTANCE AND RESOURCE AND
VACCINES.
THEY MAINTAIN THE SAME BUDGET
ALLOCATIONS FOR 23 REGIONAL BIO
CONTAINMENT LABS THAT WE
INITIALLY FUNDED IN FISCAL 2003
TO PREVENT, PREPARE FOR AND
RESPOND TO INFECTIOUS DISEASES
OUTBREAKS.
THE HOUSE BILL ALSO PRIORITIZES
FUNDING TO SUPPORT THE
CONSORTIUM OF FOOD ALLERGY
RESEARCH AND HEALTH DISPARITIES
RESEARCH.
AS I NOTED BEFORE, WE WILL HAVE
TO WAIT UNTIL THE HOUSE AND
SENATE RESOLVE DIFFERENCES
CONTAINED IN THEIR BILLS TO SEE
THE FINAL PREPORTION OF FUNDING
DIRECTED TO EARMARKS.
NOW, LET ME TAKE A FEW MOMENTS
TO BRIEFLY SUMMARIZE FUNDING
PROVIDED TO NIAID TO RESPOND
SPECIFICALLY TO THE COVID-19
PANDEMIC AND CORONAVIRUSES.
THE TOP HALF OF THE TABLE RECAPS
FUNDING BY NIAID AND THE NIH
SINCE MARCH OF 2020 THROUGH FOUR
SUPPLEMENTAL APPROPRIATIONS.
THESE FUNDS ARE AVAILABLE TO USE
UNTIL SEPTEMBER THE 30th,
2024.
NIAID'S $1.5 BILLION IN FUNDING
SUPPORTS A BROAD ARRAY OF
INTRAMURAL AND EXTRAMURAL
RESEARCH TO IMPROVE OUR
FUNDAMENTAL UNDERSTANDING OF
SARS-CoV-2, AND COVID-19
DISEASE PROGRESSION, OUTCOMES,
RECOVERY, AND TO ADVANCE THE
DEVELOPMENT OF SAFE AND
EFFECTIVE VACCINES, THERAPEUTICS
AND DIAGNOSTICS.
WE HAVE AWARDED OR COMMITTED
MORE THAN 95% OF THESE FUNDS.
NIH IS $3.3 BILLION IN ADDITION
TO COMPLIMENTING OUR ACTIVITIES
INCLUDES $1.9 BILLION TO ADVANCE
RESEARCH TO DEVELOP AND VAL DADE
NEW AS SAYS AND RETOOL EXISTING
DIAGNOSTIC PLATFORMS THROUGH
PROGRAMS SUCH AS THE RAPID
ACCELERATION OF RADX ALSO
INCLUDED IN THE $3.3 BILLION IS
$1.15 BILLION FOR NIH TO SUPPORT
RESEARCH INTO THE PROLONGED
HEALTH CONSEQUENCES OF
SARS-CoV-2 INFECTION OR ALSO
KNOWN AS LONG-COVID.
THE BOTTOM HALF OF THE TABLE
NOTES FUNDING PROVIDED TO DATE
BY THE HHS OFFICE OF THE
SECRETARY TO NIAID TO EXECUTE
NIH'S ACCELERATING COVID-19
THERAPEUTIC INTERVENTIONS AND
VACCINES OR ACTIVE PARTNERSHIP.
ACTIVE WORKS WITH THE HHS
COORDINATION OPERATIONS AND A
RESPONSE ELEMENT OR H-CORE
PREVIOUSLY KNOWN AS
COUNTERMEASURES ACCELERATION
GROUP AND OPERATION WARP SPEED.
WE DO THIS TO COORDINATE THE
GOVERNMENT'S PANDEMIC RESPONSE
AND INTERACT WITH THE PRIVATE
SECTOR TO ACCELERATE THE
DEVELOPMENT, MANUFACTURING AND
DISTRIBUTION OF COVID-19
VACCINES, THERAPEUTICS AND
DIAGNOSTICS.
THE $2.5 BILLION FOR NIAID
INCLUDES SUPPORT FOR PHASE 3
CLINICAL TRIALS OF FIVE
CANDIDATE VACCINES, AS WELL AS
VACCINES STUDIES AND SPECIAL
POPULATIONS.
FUNDING ALSO SUPPORTS CLINICAL
TRIALS TO EVALUATE COVID-19
THERAPEUTICS AND INCLUDING THE
ACT OF TWO STUDY AND ADAPTIVE
TRIAL TESTING INVESTIGATIONAL
AGENTS AND NON HOSPITALIZED
ADULTS WITH MILD TO MODERATE
COVID-19 SYMPTOMS.
IN ADDITION, THESE FUNDS SUPPORT
COMPREHENSIVE REAL-TIME RISK
ASSESSMENT OF EMERGING MUTATIONS
AND EFFORTS TO RAPIDLY
CHARACTERIZE EMERGING VARIANTS
AND ACTIVELY MONITORING THE
IMPACT ON SARS-CoV-2 VACCINES
AND THERAPEUTICS THROUGH THE
SARS-CoV-2 ASSESSMENT OF VIRAL
EVOLUTION OR SAVE PROGRAM.
NIAID HAS INVESTED $0.7 BILLION
THROUGH THE AMERICAN RESCUE PLAN
TO IMPLEMENT THE ANTIVIRAL
PROGRAM FOR PANDEMICS WHICH
INCLUDES AWARDING ABOUT
$600 MILLION TO NINE ANTIVIRAL
DRUG DISCOVERY OR AVID CENTERS
AND THESE CENTERS WILL CONDUCT
INNOVATIVE, MULTI-DISCIPLINARY
RESEARCH TO DEVELOP CANDIDATE
COVID-19 ANTIVIRALS AND
ESPECIALLY THOSE THAT CAN BE
TAKEN IN AN OUT PATIENT SETTING.
AS WELL AS ANTIVIRALS TARGETING
SPECIFIC VIRAL FAMILIES WITH
HYPO TEN SHIGH POTENTIAL TO CAUA
PANDEMIC IN THE FUTURE.
WE'RE UNCERTAIN ABOUT THE SOURCE
OF FUTURE-YEAR FUNDING TO
CONTINUE THE ANTIVIRAL PROGRAM
FOR PANDEMICS, WE'VE BEEN
WORKING ON POTENTIAL FUNDING
SOLUTIONS TO SUSTAIN THIS VERY
IMPORTANT INITIATIVE.
FOR EXAMPLE, A PARTIAL SOLUTION
IS THE SEPTEMBER 2nd PROPOSED
SUPPLEMENT THE BUDGET TO
CONGRESS FOR FISCAL 2023.
WHICH INCLUDES $22 BILLION TO
OVER ON GOING NEEDS ASSOCIATED
WITH THE COVID-19 PANDEMIC.
INCLUDED IN THAT PROPOSAL WAS
$8 BILLION FOR PROJECT COVID
SHIELD, TO DEVELOP AND LICENSE
THE VACCINES AND THERAPEUTICS
NEEDED TO BETTER ADDRESS THE
EMERGENCE OF NEW STRAINS OF
SARS-CoV-2.
WE WILL NEED TO EVADE FOR
CONGRESS TO DELIBERATE THIS
REQUEST BUT AS MANY OF YOU HAVE
HEARD, THE REPUBLICAN IN
CONGRESS HAVE MADE IT CLEAR
THEY'RE NOT SYMPATHETIC TO THIS
REQUEST FOR SUPPLEMENTAL
FUNDING.
THIS SLIDE SUMMARIZES THE NIAID
BUDGET FOR MONKEYPOX IN FISCAL
2021, 2022 AND 2023.
FISCAL 2021 FUNDING REFLECTS
NIAID'S PREPAREDNESS EFFORTS TO
STUDY HIGH-CONSEQUENCE PATHOGENS
IN KEY INTERNATIONAL LOCATIONS
WHERE THEY ARE ENDEMIC AND
INCLUDES A COLLABORATION WITH
THE RESEARCH BIOMEDICAL OF THE
DEMOCRATIC REPUBLIC OF THE CONGO
OR DRC.
WHICH EXPECTS TO SOON BEGIN A
DOUBLE-BLIND PLACEBO-CONTROLLED
TRIAL OF THE SAFETY AND THE
EFFICACY OF TPOX FOR TREATING
ADULT AND PEDIATRIC PATIENTS
DIAGNOSIS WITH MONKEYPOX.
SINCE MONKEYPOX WAS DECLARED A
PUBLIC-HEALTH EMERGENCY IN THE
UNITED STATES IN AUGUST, WE HAVE
EXPANDED OUR RESEARCH ON THE
BIOLOGY AND CLINICAL
MANIFESTATIONS OF MONKEYPOX'S
INFECTION AS WELL AS STUDIES OF
EXISTING AND POTENTIAL
INTERVENTIONS TO DIAGNOSE TREAT
AND PREVENT MONKEYPOX FISCAL
2022 INVESTMENTS REFLECT THE
ABOVE RESEARCH AREAS INCLUDING
TWO NOTABLE CLINICAL TRIALS.
ONE IS A PHASE 3 RANDOMIZED
PLACEBO CONTROL DOUBLE BLIND
TRIAL FOR THE TREATMENT OF
MONKEYPOX IN OUT PATIENT
SETTINGS IN THE UNITED STATES
THROUGHOUT AIDS CLINICAL TRIAL
GROUP.
THE SECOND, SAY CLINICAL STUDY
OF GINIOS VACCINE AT LOWER DOSE
AND BY A DIFFERENT ROUTES OF
INOCULATION IN ADULTS 18 YEARS
OF AGE OR OLDER, WHO ARE AT
HIGH-RISK FOR MONKEYPOX
INFECTION.
WE ARE CURRENTLY WORKING WITH
THE EXECUTIVE BRANCH ON
FORMULATING RESEARCH NEEDS AND
IDENTIFYING FUNDING SOURCES FOR
FISCAL 2023 MONKEYPOX RESEARCH.
NOTE, THAT ON SEPTEMBER 2nd,
THE ADMINISTRATION ANNOUNCED ITS
FISCAL 2023 SUPPLEMENTAL BUDGET
REQUEST OF $4.5 BILLION TO
ADDRESS THE CURRENT MONKEYPOX
OUTBREAKS INCLUDING IN THAT
FIGURE, IS CLOSE TO $200 MILLION
TO HHS FOR HIGH-PRIORITY
RESEARCH AND DEVELOPMENT.
INCLUDING THE EVOLUTION OF
VACCINES EFFECTIVENESS IN
SPECIAL POPULATIONS AND THE
DEVELOPMENT OF RAPID DIAGNOSTIC
TESTS.
THE BALL IS NOW IN CONGRESS'
COURT.
NOW LET ME MOVE ON TO DISCUSS
SEVERAL ITEMS OF LEGISLATIVE
INTERESTS.
NIAID-SUPPORTED RESEARCH,
INCLUDING OUR EFFORTS TO BETTER
UNDERSTAND TREAT AND PREVENT
COVID-19 AND POST ACUTE SEE
QUELL A OF COVID KNOWN AS
LONG-COVID, REMAIN TOPICS OF
GREAT INTEREST TO THE CONGRESS.
ON JUNE 16th, I TESTIFIED AT A
SENATE HEALTH EDUCATION LABOR
AND PENSIONS KNOWN AS THE HELP
COMMITTEE HEARING ENTITLED "AN
UPDATE ON THE ON GOING FEDERAL
RESPONSE TO COVID-19 CURRENT
STATUS AND FUTURE PLANNING" THE
ASSIST APARASSISTANT PREPAREDNEE
AND MY COLLEAGUES FROM CDC AND
FDA ALSO PARTICIPATED.
AS MANY OF YOU ARE AWARE IN
JUNE, I TESTED POSITIVE FOR
COVID-19, SO I JOINED THE
HEARING VIRTUALLY WHILE IN
ISOLATION SHOWN HERE DOING ZOOM
FROM MY OFFICE.
THE HEARING WAS AN IMPORTANT
OPPORTUNITY TO DISCUSS SOME OF
THE UNIQUE WAYS THE COVID-19
PANDEMIC HAS CHANGED HOW WE LIVE
AND WORK AND EMPHASIZING THAT
ADDITIONAL EFFORTS ARE NEEDED TO
FULLY CURB THE PANDEMIC.
THE COMMITTEE WAS ESPECIALLY
INTERESTED IN OUR ON GOING
EFFORTS TO BETTER UNDERSTAND AND
TREAT LONG COVID AS WELL AS OUR
PANDEMIC PREPAREDNESS EFFORTS.
I SPOKE ABOUT OUR ANTIVIRAL
PROGRAM FOR PANDEMIC AND
INCLUDING OUR ANTIVIRAL DRUG
DISCOVERY CENTERS TO DEVELOP
THERAPEUTICS THAT COULD BE
UTILIZED DURING A PANDEMIC.
I ALSO STRESS THE IMPORTANCE OF
INVESTING IN PANDEMIC PREPARED
NESTOR ABLE TO QUICKLY RESPONSE
TO THE INEVITABLE NEXT THREAT.
I WANT TO ACKNOWLEDGE ON THIS
BUSY SLIDE, THE NIAID STAFF WHO
ARE PARTICIPATE ON MY BEHALF
INCLUDING APPROPRIATION STAFF.
THESE EVENTS, AS OUTLINED ON
THIS SLIDE, HIGHLIGHT THE
CONTINUED INTEREST OF CONGRESS
IN THE BROADER NIAID RESEARCH
PORTFOLIO AS WELL AS OUR EFFORTS
TO ADDRESS COVID-19 AND ENHANCE
OUR PREPAREDNESS.
I WOULD LIKE TO TAKE A MOMENT TO
NOW REFLECT ON THE LATE
CONGRESSMAN JOHN PORTER.
A TREASURED FRIEND OF NIH WHO
PASSED AWAY SHORTLY AFTER THE
COUNCIL LAST MET IN JUNE
CONGRESSMAN PORTER SERVED AS THE
U.S. REPRESENTATIVE FOR THE
TENTH DIRECTING HE CHAIRED THE
SUBCOMMITTEE ON LABOR HEALTH AND
HUMAN SERVICES EDUCATION AND
RELATED AGENCIES FROM 1995
THROUGH 2000 AND IN THAT ROLE,
HE STRESSED ACHIEVING MEDICAL
ADVANCES TO IDENTIFY, TREAT AND
CONQUER DISEASE REQUIRES SUN
PAINT SUPPORT FOR BIOMEDICAL
RESEARCH AND NOTABLY, AS CHAIR,
OF THE HOUSE LABOR HHS
APPROPRIATIONS SUBCOMMITTEE
CONGRESSMAN PORTER LED A
SUCCESSFUL PUSH TO DOUBLE THE
ANNUAL NIH BUDGET.
YOU MAY BE AWARE THAT THE PORTER
NEUROSCIENCE RESEARCH CENTER ON
THE NIH CAMPUS IN BETHESDA IS
NAMED IN HIS HONOR IN
RECOGNITION OF HIS SUPPORT OF
NIH AND ITS MISSION AND WE ARE
GRATEFUL FOR CONGRESSMAN
PORTER'S STRONG AND SUSTAINED
SUPPORT FOR NIH AND HIS BELIEF
IN THE TRANSFORMATIVE POWER OF
MEDICAL RESEARCH.
IT WAS MY IMMENSE HONOR TO WORK
WITH CONGRESSMAN PORTER HE IS
GREATLY MISSED BY THE NIH
COMMUNITY.
I WILL DEDICATE THE REMAINDER OF
THIS SESSION TO A DISCUSSION
YOU'VE ISSUES THAT HAVE ARISEN
AND EVENTS THAT HAVE OCCURRED
AND FOLLOW UPS OF MATTERS WE
HAVE PREVIOUSLY DISCUSSED.
FIRST, AN HIV/AIDS UPDATE.
THIS SUMMER, WAS THE 21s
21st INTERNATIONAL AIDS
CONFERENCE IN MONTREAL WHICH WAS
A BOTH I AM PRESENT AND VIRTUAL
MEETING.
HENCE A HYBRID.
THE THEME WAS TO REENGAGE AND
FOLLOW THE SCIENCE.
THERE WERE MANY NEW AND
INTERESTING ISSUES THAT CAME UP,
OUR OWN VRC PROGRAM, NEW
INSIGHTS INTO IDENTIFYING HIV
CELLS AND USING THEM AS
POTENTIAL CURE TARGETS.
ANOTHER WAS AN INTERESTING
NON-AIDS ISSUE.
PRESENTED AT THE AIDS MEETING.
THIS WAS SUPPORTED BY NIAID DMID
SHOWING THAT TAKING ANTIBIOTICS
AFTER SEX CUTS CLASSICAL STIs
BY GONORRHEA, CHLAMYDIA AND
SYPHILIS BY 66% IN MEN WHO HAVE
SEX WITH MEN AND TRANSGENDER
WOMEN, BOTH LIVING WITH HIV AS
WELL AS THOSE ON PREP.
AS I MENTIONED TO THE COUNCIL IN
PREVIOUS PRESENTATIONS, WE HAVE
A VERY EFFECTIVE HIV PREVENTION
TOOLKIT HOWEVER WE ARE EXPECTING
THE EFFICACY OF THAT BY NEW
INNOVATIONS AND SUCH AS LONG
ACTING ART FOR PREP AND NUDE RAL
TRIESING ANTIBODIES AS PREP.
HERE ARE SOME EXAMPLES.
IN DECEMBER OF 2021, THE FDA
APPROVED THE FIRST INJECTABLE
TREATMENT FOR HIV PRE EXPOSURE
PROFILAXIS WHICH IS INJECTABLE
CABOTEGRAVIR EXTENDED-RELEASE
INJECTABLE SUSPENSION.
WHICH CAN BE GIVEN EVERY TWO
MONTHS AND PREVENT HIV AQUA
SITUATION AS WELL AS OR IN MANY
CASES BETTER THAN ORAL PREP WITH
TRAVADA.
ANOTHER STUDY PRESENTED AT THE
MEETING SHOWED SUSTAINED
EFFICACY OF THIS LONG-ACTING
CABOTEGRAVIR AS PREP AMONG
CISGENDER WOMEN.
THIS SLIDE SHOWS A COUPLE OF THE
STUDIES THAT ARE DONE THROUGHOUT
THE COUNTRY ON THE PROMISE OF
USING INTERMITTENT INFUSIONS 6
OF COMBINATIONS OF BROADLY
NEUTRALIZING ANTIBODIES TO
REPLACE THE NEED FOR DAILY
ANTIRETROVIRAL THERAPY GIVEN
ORALLY.
WHAT IS PLOTTED IS THE
SUPPRESSION OF PLAS MOW VIRINIA
AFTER ANY VIRAL ORAL THERAPY WAS
DISCONTINUED, AS AN ANALYTICAL
TREATMENT INTERRUPTION.
THE BROADLY NEUTRALIZING
ANTIBODY IN BLUE DIVERGES
GREATLY FROM THE PLACEBO IN RED
AND AGAIN, THESE STUDIES WILL BE
CONTINUED TO BE PURSUED FOR THE
POSSIBILITY OF INTERMITTENTLY, A
FEW TIMES A YEAR, HAVING PASSIVE
TRANSFER OF ANTIBODY REPLACE THE
NEED FOR DAILY A.R.T.
MOVING ON TO MONKEYPOX UPDATE,
IN AUGUST OF THIS YEAR, JUST
LAST MONTH, CLIFF LINE AND I
WROTE AN EDITORIAL IN THE NEW
ENGLAND JOURNAL OF MEDICINE
ENTITLED "MONKEYPOX PASS PAST AS
PROLONG" AND WE SHOWED THE
SIMILARITIES AS WELL AS
DIFFERENCES BETWEEN THE VERY
EARLY YEARS OF HIV AND WHAT
WE'RE EXPERIENCING WITH THE
EVOLUTION OF THE MONKEYPOX
OUTBREAK.
WHICH IS NOW, AS YOU KNOW,
WORLDWIDE, WITH MORE THAN 55,000
CONFIRMED CASES IN 100 COUNTRIES
AND NOW AS OF YESTERDAY, MORE
THAN 21,000 CASES IN THE UNITED
STATES WHICH AS YOU SEE, LEADS
THE COUNTRIES THROUGHOUT WORLD
IN NUMBER OF CASES.
MONKEYPOX COUNTERMEASURES ARE
AVAILABLE AS A RESULT OF WORK
DONE DECADES AGO IN PREPARATION
FOR A SMALLPOX BIO TERROR
ATTACK.
AND THEY INCLUDE TPOXX, VISITDE
AND BRYNCIDOFOVIR AND WE HAVE
JYNNEOA AS WELL AS THE ORIGINAL
ACAM2000 WHICH IS A LIVE
VACCINIA VIRUS VACCINE.
THE FDA, LAST MONTH, AUTHORIZED
THE EMERGENCY USE MAINLY IN EUA
FOR JYNNEOA GIVEN AS AN INTRA
DETERMINAL VACCINATION FOR
PEOPLE 18 YEARS OF AGE AND OLDER
AT A HIGH-RISK OF INFECTION.
BUT THE EUA ALLOWED FOR THE
INTRA DETERMINAL WHICH ACTUALLY
CAN BE GIVEN AT 1/5 OF THE DOSE
WITH COMPARABLE INDUCTION OF
IMMUNE RESPONSE.
THERE ARE CLINICAL TRIALS
LAUNCHED OR PENDING ON
MONKEYPOX.
VERY BRIEFLY, ON SEPTEMBER THE
EIGHTH, THERE WAS AN ALTERNATIVE
STRATEGY FOR ADMINISTERING INTRA
DETERMINAL DOSES OF JYNNEOS THE
INTRA DETERMINAL I MENTIONED.
ON THE NINTH OF SEPTEMBER, IT
WAS A CLINICAL TRIAL OF TPOX IN
THE UNITED STATES AS OUT PATIENT
TREATMENT FOR PEOPLE WITH
MONKEYPOX AND WHAT'S PENDING
NOW, AND WILL START THIS MONTH
IS A TPOX STUDY IN THE
DEMOCRATIC REPUBLIC OF THE CONGO
A STUDY LED BY CLIFF LANE.
LET'S MOVE ON TO COVID UPDATES.
THERE HAVE BEEN RECENT PAPERS
NOW THAT STARTED OFF AS PRE
PRINTS THAT ARE NOW BEEN
PUBLISHED IN CELL AND SCIENCE
HIGHLY PEER-REVIEWED SHOWING
RATHER STRONG EVIDENCE FOR THE
NATURAL OCCURRENCE AND EVOLUTION
OF THE COVID-19 OUTBREAK FROM
THE WUHAN MARKET IN CENTRAL
CHINA AND THE DATA FROM HIGHLY
QUALIFIED VIROLOGIST HAVE
ANALYZED THE IN A STRONG WAY
THIS WAS A NATURAL OCCURRENCE
JUMPING FROM ANIMALS BROUGHT TO
THE WUHAN MARKET.
LET'S TAKE A LOOK AT THE EPI.
CURRENTLY, THERE ARE OVER
600 MILLION REPORTED CASES AND
SIX AND A HALF MILLION DEATHS
GLOBALLY AND OTHERS I MENTIONED
LAST TIME THE UNITED STATES IS
DOING POORLY ON THIS AND ALMOST
100 MILLION REPORTED CASES AND
NOW OVER 1 MILLION DEATHS OVER
THE TWO AND A HALF YEARS OF THIS
OUTBREAK.
AS SHOWN HERE, WE ARE DOMINATED
BY A BA5 ISOLATE SHOWN IN THE
PURPLE ON THE RIGHT-HAND SIDE
WHICH GRADUALLY.
>> IF YOU LOOK AT THE DAILY
CONFIRMED CASES IN THE UNITED
STATES, AND COMPARE LAST WINTER
IN JANUARY WITH TODAY, EVEN
THOUGH THAT NUMBER IS
UNACCEPTABLY HIGH AT A WEEKLY
AVERAGE OF 75,000, IT IS A BIG
DIFFERENCE FROM WHAT WE SAW IN
JANUARY OF 800,000 A DAY.
SAME WITH THE DEATHS.
IN JANUARY WE WERE AVERAGING
OVER 6,000 DEATHS PER DAY AND WE
ARE NOW ABOUT 400.
AGAIN, 400 IS AN UNACCEPTABLY
HIGH LEVEL BUT JUST TO SHOW YOU
THE DIFFERENCE BETWEEN THE STAGE
IN JANUARY, AND WHERE WE ARE
TODAY.
AS I MENTIONED MANY TIMES, WE
HAVE A THERAPEUTIC TOOLKIT FOR
NON-HOSPITALIZED PATIENTS WITH
PAXLOVID SHOWING CLEAR-CUT,
HIGHLY EFFECTIVE AND KEEPING
PEOPLE OUT OF THE HOSPITALS AS
WELL AS OTHERS INCLUDING
RECOMMENDDESIVIR AND MOLNUPIRAVI
R & B TELOVIMAB AND ALSO A
PROFILAXIS REDUCED THE RISK BY
80% OF DEVELOPING SYMPTOMATIC
COVID COMPARED TO A PLACEBO.
WE KNOW OF THE VACCINES WITH THE
MODERNA AND THE BIOEN TECH
PFIZER AND mRNA AS WELL AS THE
J AND J AND NOW OTHERS INCLUDING
THOSE AVAILABLE THROUGH EUA OR
AS A BLA.
RIGHT NOW WE'RE FOCUSING ON
UPDATING THE VACCINES FOR THE
ENTIRE COUNTRY AND NOW, THERE
WAS A PRELIMINARY RESULT
REPORTED IN A PRE PRINT THAT
HIGHER OMICRON BA1 TITERS WERE
OBSERVED COMPARED TO PROTOTYPE
VACCINES AND THE TITERS AGAINST
THE OMICRON BA45 WERE LOWER
AGAINST BA1 ON ALL CANDIDATE
VACCINES.
BUT BASED ON THE TOTALITY OF
EVIDENCE, AND THE EXPERIENCE OF
THE BA1 OMICRON BIVALENT, THE
CDC RECOMMENDED THE FIRST
UPDATED COVID-19 BOOSTER WHICH
IS A BIVALENT BA4-5 VACCINE AND
FOR INDIVIDUALS OLDER THAN 12 OR
OLDER FOR THE PFIZER mRNA AND
INDIVIDUALS 18 OR OLDER WITH THE
MODERNA mRNA.
AND IN THE COMING WEEKS, THE CDC
WILL BE EXPECTED TO RECOMMEND
THAT UPDATED BOOST FOR THE OTHER
PEDIATRIC GROUPS NAMELY THOSE
YOUNGER THAN 12.
LET ME QUICKLY MOVE ON TO NOW A
REAL NEED, THE NEXT GENERATION
CORONAVIRUS VACCINES.
EITHER THE PAN-AND WE WROTE A
PERSPECTIVE CALLING THE
UNIVERSAL CORONAVIRUS VACCINES
TRULY AN URGENT NEED GIVING THE
EXPERIENCE WE'VE HAD WITH
MULTIPLE VARIANTS.
THERE'S A LOT OF REALLY GOOD
WORK ALREADY GOING ON IN THE
SPACE OF PAN CORONAVIRUS
VACCINES PRE CLINICAL AND EARLY
CLINICAL WORK.
IN FACT, THERE'S A PAPER THAT
JUST CAME OUT IN SCIENCE ABOUT A
MONTH AGO, USING NANO PARTICLES
WHICH PROTECT AGAINST CHALLENGED
BY DIVERSE VIRUSES IN ANIMAL
INFORMEDEL AND THE NIAID HAS
MADE SIX RECENT AWARDS TOTALING
ALMOST $60 MILLION FOR RESEARCH
ON THESE BROADLY-PROTECTIVE
CORONAVIRUS VACCINES WITH
THREE-YEAR GRANTS IN THE
INSTITUTION'S SHOWN HERE.
ALSO, MUCOSAL VACCINES, WE KNOW,
ARE EXTREMELY IMPORTANT FOR OUR
FUTURE AGAINST PROTECTING
INFECTION AND TRANSMISSION.
THIS WAS NICELY REVIEWED IN AN
ARTICLE LAST MONTH BY ERIC TOPOL
ABOUT WHAT WE NEED TO DO WITH
REGARD TO NASAL VACCINES TO
COUNTER FUTURE COVID-19 AS WELL
AS PRESENT AS ILLUSTRATED DEM
ATTICLY THESE TYPE OF VACCINES
WILL GIVE FASTER I AM AN TEE
RECALL AFTER EXPOSURE AND ARE
GEARED AT INFECTION AND
TRANSMISSION BLOCKING.
AND ALSO THE ADVANTAGE OF BEING
NEEDLE FREE.
ONE EXAMPLE OF THIS IS AN
INACTIVATED WHOLE VIRUS
CONSISTING OF SARS-CoV-2 FROM
DIFFERENT STRAINS GIVEN BY AN
INTER NASAL MIST IN A STUDY BY
JEFF TAUBENBERGE SO THERE ARE
GOOD PEOPLE EXTRAMURALLY WORKING
ON THIS AND VERY QUICKLY LET ME
CLOSE WITH A COUPLE OF OTHER
UPDATES.
VERY EXCITING WORK COMING FROM
THE VRC WITH BOB CEDAR AND HIS
COLLEAGUES IN A SINGLE INJECTION
OF THE ANTIBODY L9LS WAS SAFE
AND HIGHLY PROTECTED IN THE
UNITED STATES ADULTS EXPOSED TO
MALARIA PARASITES AND WE'RE
GOING TO DO A LARGER TRIAL IN
AFRICAN INFANTS AND CHILDREN.
WE CONTINUE WITH THE WORK
TOWARDS OUR PROTOTYPE PATHOGENS
APPROACH FOR VACCINES AND MONO
CRON ALAN TEE BODY WHICH SAY
CRITICAL CAM PHONE ANT OF THE
BROADER NIAID PLAN FOR PANDEMIC
PREPAREDNESS.
OUR STAFF AND I OUTLINED THIS IN
A RECENT COMMENTARY IN THE
JOURNAL OF INFECTIOUS DISEASES.
THESE ARE THE TOP PRIORITIES OF
THE VARIOUS FAMILIES AND WE'RE
ALREADY WORKING ON SEVERAL OF
THESE, FOR EXAMPLE, WE LAUNCHED
THE CLINICAL TRIAL OF mRNA NIP
OWE VIRUS VACCINES AS PHASE 1 AT
THE NIH CLINICAL CENTER AND A
PREVAIL STUDY DONE IN LI LIBERIS
A VACCINE AGAIN A VERY IMPORTANT
DISEASE IN THAT PART OF THE
WORLD.
AND ALSO THERE'S ENCOURAGING
PROGRESS ON RSV VACCINES WORK
THAT ORIGINATED FROM THE
FUNDAMENTAL BASIC RESEARCH DONE
BY BONNIE GRAHAM IN THE VRC
YEARS AGO.
AND LET ME CLOSE ON THIS LAST
SLIDE, SO THAT WE DON'T FORGET
THE IMPORTANCE OF THE WORK THAT
WE'RE DOING TO DEVELOP A CURE
FOR HEPATITIS B AS SHOWN IN OUR
UPDATE THAT WAS PUBLISHED BY THE
NIH HEPATITIS B STRATEGIC PLAN
WORKING GROUP IN JULY 20622.
OF 2022.
SO I'LL STOP THERE AND BE HAPPY
TO ANSWER ANY QUESTIONS.
THANK YOU.
>> OK, WELL, IF THERE ARE NO
QUESTIONS, I CAN SEE, WE'LL HAVE
TIME AT THE END AND I'LL BE ABLE
TO GIVE THE OPPORTUNITY AFTER WE
GET THE LAST PRESENTATION FROM
Dr. HOLLAND.
I DID NOT MENTION IN THE
INTERESTING SOMETHING THAT I
SHOULD HAVE AND THAT IS THAT
THERE ARE SEVERAL MEMBERS WHOSE
TERMS ARE EXPIRING ON
OCTOBER 2022.
AND I JUST WANT TO MENTION THEM
AND THANK THEM FOR THEIR SERVICE
TO US AND THAT IS Dr. ARGUILE,
Mr. IBOW, Dr. GUPTA, Dr.
RANDOLPH, AND Dr. RAY, SO
THANK YOU SO MUCH FOR YOUR
SERVICE TO US.
AND BEFORE I INTRODUCE OUR NEXT
SPEAKER, I JUST WANTED TO
ACKNOWLEDGE AFTER 38 YEARS
PRESIDING OVER THESE COUNCIL
MEETINGS, THIS WILL BE THE LAST
COUNCIL MEETING I WILL ADDRESS
AS NIAID DIRECTOR AND I JUST
WANT TO MENTION VERY SINCERELY
THIS HAS BEEN AN ENORMOUS
PLEASURE AND PRIVILEGE OF MY JOB
TO HAVE WORKED WITH THE MANY
EXTRAORDINARY AND TALENTED
INDIVIDUALS WHO SERVED ON OUR
COUNCIL, OVER THE YEARS.
WE HAVE A TRULY OUTSTANDING
INSTITUTE STRENGTHENED BY OUR
INTERACTIONS WITH OUR COUNCIL.
I'M CONFIDENT THE INSTITUTE WILL
BE IN KALE ABLE HANDS AFTER I
LEAVE AND I WANT TO THANK THOSE
OF YOU HERE TODAY FOR YOUR
SERVICE TO OUR INSTITUTE AS WELL
AS PAST COUNCIL MEMBERS THAT
HAVE SERVED US SO WELL OVER THE
YEARS.
COUNCIL MEMBERS ARE CRITICAL
ADVISERS WHO BRING TO THE TABLE
OUTSIDE PERSPECTIVES AND IDEAS
THAT HELP AND SHAPE AND ADVANCE
OUR MISSION SO THANK YOU SO MUCH
FOR THAT.
NOW I WOULD LIKE TO INTRODUCE
Dr. STEVEN HOLLAND THE
DIRECTOR OF YOU ARE INTRAMURAL
RESEARCH PROGRAM WHO WILL
PRESENT DURING THE NEXT PART OF
OUR PROGRAM.
STEVE, OVER TO YOU.
>> THANK YOU SO MUCH, TONY AND
THANK YOU FOR YOUR EXTRAORDINARY
YEARS OF SERVICE.
IT HAS BEEN A REAL HONOR AND
PLEASURE TO SERVE UNDER WOW.
AND I WILL NOW JUST GIVE A VERY
BRIEF UPDATE ON THE INTRAMURAL
PROGRAM AND I'M GOING TO SHARE
MY SLIDES HERE BRIEFLY.
IS THAT IN THE RIGHT MODE?
>> THAT'S CORRECT.
>> VERY GOOD.
OK, SO I WILL GET RIGHT TO THE
POINT.
I'M GOING TO TALK TO YOU ABOUT
THE INTRAMURAL PROGRAMS AND THE
PRESENT, THE RECENT PAST THIS
LAST YEAR AND SOME VERY FEW
SELECT RESEARCH HIGHLIGHTS AND
THEN I NEED YOUR HELP AT THE
VERY END.
SO, REMEMBER, INTRAMURAL
RESEARCH, INSIDE THE WALLS IS
WHAT WE'RE TALKING ABOUT AND THE
CURRENCY STEMS FROM THE BOARD OF
SCIENTIFIC COUNCILORS REVIEW.
EVERY LAB, EVERY PRINCIPLE
INVESTIGATOR, AT LAST EVERY FOUR
YEARS GETS REVIEWED AND THIS IS
A LARGE HIGHLY PROFESSIONAL,
VERY ACCOMPLISHED GROUP, MANY OF
YOU HAVE SERVED ON THESE
COMMITTEES.
CURRENTLY, WE ONLY DO IT TWICE A
YEAR IN DECEMBER AND JUNE AND
WE'RE DOING OUR BEST TO KEEP IT
TO THAT LEVEL.
IT'S HARD, INTENSE AND IT'S A
LOT OF READING AND A LOT OF
QUESTIONING AND A LOT OF
LEARNING FOR EVERYBODY INVOLVED.
WE STRIVE TO MAKE SURE THAT ALL
OF OUR WORK IS AGAIN EYE INLY
OUT STANDING AND WE NEED YOUR
INPUT TO MAKE SURE THAT WE STAY
TO THAT MARK.
AND REALLY FROM THAT EVALUATION,
ALL THINGS FLOW.
THIS IS JUST A BRIEF LOOK AT THE
NUMBER OF PRINCIPLE
INVESTIGATORS IN THE INTRAMURAL
PROGRAM.
WE HAVE FLUCTUATED SOME OVER THE
YEARS AND WE'VE NOW GOT A GOOD
NUMBER ON TENURE TRACK AND WE'RE
LOOKING FORWARD TO MAKING THESE
THINGS COME TO LIFE.
SO, REMINDING YOU THE PROGRAM
HAS SEVERAL COMPONENTS.
THE INTRAMURAL PART HERE IN
BETHESDA IS SHOWN AT THE TOP OF
THE SLIDE.
OUR CAMPUS AT ROCKY MOUNTAIN IN
HAMILTON, MONTANA, WHERE WE DO
SO MUCH OF THE REALLY
EXTRAORDINARY VSL3 AND 4 WORK
AND THERE ARE MANY SITES AROUND
THE GLOBE THAT ARE PART OF THE
INTRAMURAL PROGRAM AS WELL AS
MANY CRITICAL EXTRAMURAL
COMPONENTS.
SO OUR PRIORITIES IN THE
INTRAMURAL PROGRAM ARE TO MAKE
SURE WE'RE DOING TRANSFORMATIVE
MEDICINE AND BIO MEDICAL
RESEARCH AND THE
BENCH-TO-BEDSIDE APPROACH THAT
TAKES FULL ADVANTAGE OF THE
CLINICAL CENTER WHICH IS REALLY
QUITE A PRIVILEGE TO HAVE AND AS
WELL AS OUR DOMESTIC AND
INTERNATIONAL SITES.
WE WANT TO BE RESPONDING TO
PUBLIC-HEALTH THREATS INCLUDING
DRUG RESISTANT MICROBES,
EMERGING VIRUSES AND THE
DESPERATELY NEEDED VACCINES THAT
HAVE BEEN SO IMPORTANT TO US.
WE WANT TO PARTNER TO ADVANCE
THESE APPROACHES AND TO DO IT
ACROSS BOTH INFECTIOUS AND
IMMUNE LOGIC DISEASES.
SO WHAT HAVE WE DONE IN THE LAST
YEAR?
WE'VE GOT 802 PUBLICATIONS SO
FAR AND THE YEAR IS NOT OVER FOR
US.
THERE HAVE BEEN MANY THINGS
HIGHLIGHTED BY THE NIAID BLOG
AND WE HAVE ABOUT 200 ACTIVE
CLINICAL STUDIES GOING ON
THROUGH THE INSTITUTE.
AS TONY MENTIONED, COVID FUNDING
HAS BEEN AN IMPORTANT PART OF
WHAT WE'VE BEEN WORKING WITH FOR
THE LAST COUPLE OF YEARS.
AND WITH THAT FUNDING, WE HAD
MORE THAN 60% OF OUR PRINCIPLE
INVESTIGATORS TAKE ON AND
DEVELOP COVID PROJECTS LEADING
TO NOW 451 PUBLICATIONS AND
80PIs AND BRANCHES WERE FUNDED
INITIALLY.
CURRENTLY THAT NUMBER HAS FALLEN
A LITTLE BIT AS PEOPLE HAVE
COMPLETED PROJECTS THAT HAVE NOW
MOVED ON BACK TO THEIR PRIMARY
INTERESTS.
ONE OF THE APPROACHES WE'VE
TAKEN TO THIS IS TO CREATE A
SARS-CoV-2 VIROLOGY CORE WHERE
WE CAN DO THE VSL3 WORK REQUIRED
WITH PEOPLE WHO ARE EXPERT IN IT
SO LABS WITH GOOD IDEAS COULD
COME IN AND MAKE THOSE IDEAS
WHOLE BUT DO IT WITH EXPERTS
THAT WILL HELP US TO DO IT
SAFELY.
TED PIERSON THE CHIEF OF THE
LABRADOR OF VIRAL DISEASES PUT
TOGETHER THIS OUTSTANDING GROUP
LED BY REID JOHNSON AND NICOLE
LACKMIRE AND IT'S BEEN
SUPPORTING RESEARCH FROM AROUND
THE CAMPUS FROM LABORATORIES
THAT DID NOT HAVE BSL3 CAPACITY.
IT'S BEEN VERY SUCCESSFUL AND AS
WE TRY TO THINK THROUGH WHAT IS
THE APPROACH WE WANT TO BE
DEVELOPING FOR PANDEMIC
PREPAREDNESS IN THE INTRAMURAL
PROGRAM, THIS IS ONE OF THE
THINGS THAT I THINK WILL BE A
PARADIGM FOR US.
OF COURSE, IN THE LAST FEW
MONTHS, MONKEYPOX HAS BEEN AN
IMPORTANT COMPONENT OF OUR
THINKING AND VINCENT MUNSTER HAS
RISEN TO THE TASK HERE AND
STUDYING VIRAL EVOLUTION,
DIAGNOSTICS, THERAPEUTICS, AND
ENVIRONMENTAL STABILITY AS WELL
AS TRANSMISSION IN BOTH STUDIES
IN THE CONGO AS WELL AS IN
MONTANA.
MOVING TO SOME OF THE CHANGES IN
THE INTRAMURAL PROGRAM, WE'VE
HAD TWO NEW LABORATORY CHIEFS
SELECTED IN THE LAST YEAR AND
CAROLINA MURRAY WHO IS NOW THE
CHIEF OF THE LABORATORY OF
MALARIA VECTOR RESEARCH AND A
WORLD-RENOWNED INVESTIGATOR AND
SONIA BEST THE CHIEF OF THE LAB
TORE' OF PERSISTENT VIRAL
DISEASES NOW THE LABORATORY OF
NEWER LOGIC INFECTION AND
IMMUNITY.
SHE'S A VIROLOGIST AND
IMMUNOLOGIST WHO WILL MARY THOSE
THINGS TOGETHER AROUND -- MARRY
THESE THINGS AROUND THE
SYNDROMES.
WE'VE BEEN INCREASING OUR NUMBER
OF DEPUTY LAB CHIEFS IN
RECOGNITION THAT YOU KNOW, DEATH
TAXES AND ADMINISTRATIVE BURDENS
ARE ALL INEVITABLE PARTS OF LIFE
AND SO WE'VE BEEN GATHERING HELP
TO DO THIS AND IN THE LABORATORY
OF PARASITIC DISEASES, AMY
KLEEON AND ELODIE GHEDIN HAVE
JOINED THAT PROGRAM.
WE'VE BEEN ADDING TO OUR RANKS
AS WELL, THIS YEAR, WE HAVE A
TENURED INVESTIGATOR AND YOU SAW
ULA'S WORK ASK I'LL SHOW YOU
MORE OF THAT IN A MOMENT.
WE'VE GOT THREE-NEW TENURE TRACK
INVESTIGATORS COMING INTO THE
TOP TWO.
ERIC VAN DANG AND HAU JIN ARE
JOINING AND ERIC WILL WORK ON
FUNGI AS PART OF THE MICRO BUY
HOME AND HAO JIN WILL WORK ON
NEURO LOGIC FUNCTION AND
IMMUNITY AND HOW THOSE TWO
THINGS INTERFACE AND TIJANA
IVANOVICH IS JOINING LOOKING AT
THE ULTRASTRUCTURE OF HOW
VIRUSES GET INTO AND LIVE WITHIN
CELLS.
JUST REMIND YOU, OUR TENURE
TRACK PROGRAM, WE HAVE SEVERAL
DIFFERENT ROADS THAT LEAD TO THE
SAME DESTINATION.
AND THERE BE CAN A TENURE TRACK
SEARCH SELECTED BY A LAB FROM AN
ADD.
THERE IS SOMETHING CALLED THE
EARLY STADTMAN PROCESS THAT ARE
OPEN APPLICATIONS BASIC SIGNS
AND THAT COME IN FROM ALL AROUND
THE COUND TREE AND AROUND THE
WORLD AND THE LASKER CLINICAL
PROGRAM WHICH IS AGAIN AN OPEN
PROCESS FOR CLINICAL APPLICANTS
AND THAT STAY HERE FOR FIVE
YEARS AND HAVE A CHANCE TO STAY
OR GO TO THE OUTSIDE WITH
SUPPORT AND THEN FOR ALL OF
THESE GROUPS, THERE'S WHAT IS
CALLED THE DISTINGUISHED SCHOLAR
PROGRAM WHICH IS FOR PEOPLE WITH
A DEMONSTRATED AND SIGNIFICANT
COMMITMENT TO DIVERSITY AND WE
ARE VERY PROUD TO HAVE EIGHT
DISTINGUISHED SCHOLARS IN THE
TIRIN TRA MURAL PROGRAM.
JOHN ZHANG LEFT TO FORM A
PROGRAM AT YALE AROUND BIG
OMICS-TYPE RESEARCH IN
IMMUNOLOGY AND YOU KNOW ABOUT
SOME OF OUR UPCOMING
RETIREMENTS.
TONY HAS MENTIONED HIS AND THE
HAR LA CALDWELL WILL STEP DOWN,M
LIDO WHO HAS BEEN A LEADER IN
BIOLOGY WILL BE RETIRING NEXT
YEAR.
ELLEN CHER WHO LED CURRENTLY
HELPS ONE OUR OX CAM PROGRAM
WILL BE STEPPING DOWN THIS YEAR.
ROCKY MOUNTAIN LABS, WE'VE HAD A
REAL TURNOVER WHICH IS WHY SOME
OF THE TENURE TRACKS LAST YEAR
ARE OUT THERE AND JOE HINABUSH,
BOB HEINESON, FRANK GHERADINI,
DANA SCOTT WHO LED THE ROCKY
MOUNTAIN VETERINARY BRANCH AND
PATTY ROSA WHO ALSO LED THE
LABORATORY OF BACK TERROLOGY FOR
MANY YEARS AND HAS BEEN A LIME
INVESTIGATORS.
ON THIS CAMPUS, WE HAVE TWO LAB
CLOSINGS THAT IS DIFFERENT THAN
RETIREMENT.
THESE PEOPLE WILL BE STAYING ON.
JOHN GALLON WILL BE CLOSING HIS
LABORATORY AFTER SEVERAL DECADES
AND I THINK FIVE DECADES OF
SUCCESSFUL CRITICAL WORK AND HE
WILL STILL ON FOR CLINICAL
RESEARCH AND THE CHIEF
SCIENTIFIC OFFICER OF THE
CLINICAL CENTER AND BOB MUNFORD
WHO HAS BEEN THE SENIOR
CLINICIAN IN THE LABORATORY OF
CLINICAL IMMUNOLOGY AND
MICROBIOLOGY WAS DEPUTY LAB
CHIEF FOR MANY YEARS AND HAS
BEEN OVERSEEING OUR SCIENTIFIC
REVIEWS WILL BE CLOSING DOWN HIS
SECTION BUT CONTINUING ON STAFF
FOR A WHILE.
THIS LEAVEs WITH SEVERAL
OPENINGS THAT WE'RE LOOKING TO
FILL.
WE REALLY WOULD APPRECIATE YOUR
HELP IN THIS.
THE ROCKY MOUNTAIN VET TRA NAIR
YAN BRANCH IS OPEN AND THE
LABORATORY OF ALLERGIC DISEASES
HAS TWO TENURE TRACK POSITIONS
IT'S LOOKING TO FILL AND THEN WE
ARE, AS YOU KNOW, LOOKING FOR
LABORATORY CHIEFS.
THE LABORATORY OF IMMUNO
REGULATIONS THAT IS TONY'S
LABORATORY, WILL BE LOOKING FOR
A NEW CHIEF IN THE NEXT YEAR AND
THE LABORATORY OF IMMUNOGENETICS
LED BY SUE PIERCE WHO WILL STEP
DOWN SOON, WILL LOOK FOR A
CANDIDATE INTERNALLY BECAUSE OF
SPACE CONSIDERATIONS.
JUST A COUPLE OF VERY QUICK
RESEARCH HIGHLIGHTS.
WE ARE STILL DOING A LOT OF
COVID WORK AS I KNOW MANY OF YOU
ARE AS WELL.
WE HAVE PUT TOGETHER A
MULTI-NATIONAL TRIAL TRYING TO
LOOK AT A MULTI OMIC APPROACH O
CHILDREN LOOKING AT MISS C AND
AT PEDIATRIC ACUTE COVID AS WELL
AS HEALTHY CONTROLS AND I THINK
YOU CAN SEE HERE THE LARGE
NUMBER OF RED SPOTS ON THE LEFT
IN THE COHORT AND IN THE ACUTE
COHORT IN BLUE AND REALLY
IDENTIFYING THEM AS DISTINCT
DISEASES AND HE HAS BEEN
IDENTIFYING TARGETS.
KATIE BOSSOIO HAS BEEN IMMUNO
METABOLISM TO COVID.
LAST YEAR SHE WORKED ON THIS IN
A HUMAN COHORT FROM YALE AND
THIS YEAR SHE'S WORKING WHAT
DOES THE RECEPTORS FOR ADVANCES
GLY INDICATION OR RAGE HAS TO DO
WITH IT AND IF YOU BLOCK RAGE
YOU CAN INCREASE SURVIVAL IN A
MOUSE MODEL GIVING KATIE NEW
TARGETS TO GO AFTER IN TERMS OF
THERAPEUTICS.
FOLLOWING ALONG THE SAME SORT OF
HOW TO USE THE MOUSE MODEL,
SONIA BEST HAS PUT TOGETHER A
REALLY IMPORTANT STUDY WITH
NADDIA ROSENTHAL FROM JACK'S
LABS USING THE COLLABORATIVE
CROSS TO LOOK AT MOUSE GENETICS
AND HOW WE CAN USE THOSE.
I WANT TO POINT OUT HERE, ON THE
LEFT SIDE, YOU SEE IN THE
LEFT-TOP PANEL, MICE THAT DIE.
THESE ARE ACE 2 TRANSGENIC MICE
IN THE COLLABORATIVE CROSS.
THEY DIE WITH COVID.
OK, THEN THERE'S SOME MICE THAT
ARE RESISTANT THAT TELL US MOUSE
GENES WE CAN GO AND IDENTIFY.
IF YOU GO INFORM THE RIGHT SIDE,
IT'S LESS EXPECT AND MORE
INTERESTING.
WHAT YOU SEE ON THE TOP, IS THAT
HERE IS A STRAIN OF MICE IN
WHICH THE MALES ARE DRAMATICALLY
MORE SUSCEPTIBLE TO COVID
INFECTION AND NOT TOO DISSIMILAR
FROM WHAT IS SEEN IN HUMANS AND
ON THE BOTTOM, YOU SEE STRAINS
ONLY THE FEMALE CARRY THE HIGH
SUSCEPTIBLE.
IT'S FASCINATING TO DISSECT THE
GENETICS IN THE MOUSE THAT WE
CAN GO BACK TO THE HUMAN TO
INTERROGATE.
FINALLY, ULA BUCKHOLD WORKS ON
TRYING TO IDENTIFY VACCINES THAT
ARE GOOD AGAINST COVID.
SHE'S VERY INTERESTING IN RSV
AND OTHER INFECTIONS AS WELL.
IN THIS PARTICULAR PAPER, STILL
IN THE PRE PRINT, WHAT YOU SEE
IS IS SHE'S USING THE BOVINE
HUMAN PARA 3 TO MAKE A SPIKE
EXPRESSING VIRUS THAT IS HIGHLY
STABILIZED AND WHAT YOU CAN SEE
HERE, IF YOU LOOK AT THE BOTTOM
PANEL, IN LUNG TISSUE, YOU CAN
REALLY PREVENT THE PROLIFERATION
OF SARS-CoV-2 AFTER A VIRUS
CHALLENGE IN MACAQUES.
SO HOPE THAT THIS MUCOSAL
VACCINE COULD BE USEFUL.
NOW, YOU KNOW, HAS THERE NOT
MORE THAN COVID?
OF COURSE.
AND THERE WILL CONTINUE TO BE
MORE THAN COVID.
WE HAVE OTHER PANDEMIC THREATS
TO WORRY ABOUT, HINES FELDMAN
WORKS ON FEVER.
CAN YOU SEE THIS VIRUS THAT THIS
VACCINES THAT IS PROFOUNDLY
PROSPECTIVE AGAINST CCHF AND
HEINZ HAS BEEN TAKING THIS
FORWARD.
WE STILL HAVE MANY DIFFERENT
CONTROLS TO UNDERSTAND HOW
IMMUNE FUNCTION AND DYSFUNCTION
WORK.
HERE IN THIS REALLY ELEGANT
TRANS INSTITUTE COLLABORATION
BETWEEN YASMIN AND JULIE AND LED
LOOKING HOW IS IT THAT
ANTIBIOTICS, PRE DISPOSE TO
FUNCTIONAL INFECTION.
WE DON'T TYPICALLY THINK ABOUT
BACTERIA BEING THE CAUSE OF
FUNGAL DISEASE BUT AS YOU SEE IN
THIS SCHEMATIC ON THE LEFT, IT'S
THE REDUCTION IN CERTAIN
BACTERIA AND THE GROUND POSITIVE
CATEGORY THAT DIMINISH THE TH-17
ACTIVATION THAT ALLOW FOR FUNGAL
PROLIFERATION AND CANADA DEEMIA
AND PUTTING THESE MECHANISMS
INTO CONTEXT IS WHAT WILL GIVE
US REAL INSIGHTS TO GO FORWARD
AND IDENTIFY SOME OF THE WAYS
THAT WE TREAT OUR INTENSIVE CARE
PATIENTS AND SO ON.
AND THEN STAYING WITH THE BOWEL
AS CRITICAL SITE OF ACTIVITY,
MIKE LEARNARD OWE AND CO-WORKERS
TOOK A HUMAN MUTATION THAT WAS
RECOGNIZED IN A GENE INVOLVED IN
MUCUS PRODUCTION TO RECOGNIZE
THE CRITICAL ROLE FOR MUCUS
SIGHALLATION IN MANAGING
INDESTINATION HOST COMME COMMENE
HOMEOSTASIS.
IT HAS GIVEN US NEW IN SIGHT
INTO HOW THE BOWEL FUNCTIONS AND
HOW THE BOWEL PROTECTS ITSELF
FROM INVASION.
LASTLY, AS I CAME INTO THIS
POSITION SEVERAL YEARS AGO, WE
TALKED ABOUT A NEW APPROACH TO
DOING HUMAN EX OWN SEQUENCE AND
NOW HUMAN GENOME SEQUENCING.
I WANT TO SHARE THE RESULTS OF
THE FIRST 1,000 INDIVIDUALS SO
OUR APPROACH HERE IS THAT EVERY
PATIENT WHO COMES INTO THE
NIAID, WHETHER THEY'RE NORMAL
VOLUNTEER OR HIV INFECTED,
IMMUNODEFICIENCY IS OFFERED THE
CHANCE TO HAVE A WHOLE GENOME
SEQUENCE DONE AND THE FIRST
1,000 PATIENTS THAT WERE
SEQUENCES ARE SHOWN HERE.
IT'S TOO SMALL TO READ WHAT THE
GENES ARE AND IT'S VERY SKEWED
TOWARDS THE DISEASES THAT WE
STUDY A LOT OF.
IF WE BREAK IT DOWN WHAT'S DID
WE FIND IN LOOKING AT THE FIRST
1,000.
WE FOUND MOLECULAR DIAGNOSIS IN
33%.
17 OF THOSE PEOPLE HAD COPY
NUMBER VARIANTS, KIND OF STUFF
YOU DON'T PICK UP ON WHOLE EX
OWN SEQUENCING AND 32 OF THOSE
PEOPLE HAD SECONDARY FINDINGS
THAT'S THE KIND OF GENETIC
PROBLEMS THAT THE AMERICAN
COLLEGE OF MEDICAL GENETICS SAYS
YOU NEED TO TELL PEOPLE ABOUT
THIS WHETHER IT'S BRACK A 2 OR
SOMETHING LIKE THAT.
AND THEN 31 PEOPLE HAD MULTIPLE
MOLECULAR DIAGNOSIS.
IF YOU HAVE ONE MENDILIAN
MUTATION, WHAT'S THE LIKELIHOOD
YOU HAVE A SECOND ONE AND THE
RATE FROM THAT RANGES FROM FIVE
TO 10%.
THINK ABOUT IT, JUST BECAUSE YOU
GOT ONE PROBLEM, DOESN'T MEAN
YOU DON'T HAVE TWO AND THEN IN
AR PARADIGM FOR WHERE WE'RE
GOING, REANAL SIGHS IDENTIFIED
22 MORE DIAGNOSIS AND IN NINE OF
THOSE 22, THEY WERE NOVEL
DISEASE GENE ASSOCIATIONS.
SO, THIS IS REALLY WHERE THE
FIELD IS HEADED AND I THINK
WHERE WE'RE TAKING A GOOD ROLE
HERE.
SO, COMING TO THE END HERE, WHAT
ARE OUR FUTURE DIRECTION THIS IS
WE'RE OBVIOUSLY STILL WORKING
HARD TO RECRUIT TALENTED AND
DIVERSE INVESTIGATORS AND HE
WANT TO FOSTER THESE
BENCH-TO-BET SIDE APPROACH AND
MAKE SURE THE CLINICAL CENTER
RESOURCES ARE AVAILABLE TO ALL
LABS, WHETHER BASIC OR CLINICAL.
THAT IS WHERE WE CAN BRING THIS
ALL TOGETHER.
WE WANT TO PROMOTE THIS STUDY OF
PATHO PHYSIOLOGY, INNOVATIVE
STRATEGIES, VACCINES TARGETS,
DIAGNOSTICS AND THERAPEUTICS AND
ENCOURAGE OUR EXTRAMURAL AND
INTERNATIONAL COLLABORATIONS.
SO, NOW I'VE FINISHED THAT PART
AND GIVE ONE LAST THING I NEED
TO ASK FOR YOUR HELP WITH AND
THIS IS CALLED A CONCEPT
CLEARANCE.
SOMETIMES WE DO THIS IN THE
SMALLER GROUPS AND I'M GOING TO
TAKE ADVANTAGE OF HAVING YOU
ASSEMBLED HERE.
WE NEED YOUR ADVICE ON WHETHER
WE CAN GO FORWARD WITH
IMPLEMENTING THIS APPROACH.
SO THE CONCEPT CLEARANCE IS FOR
SCIENTIFIC AND TECHNICAL STAFF
AND SERVICES TO SUPPORT
COLLABORATION WITH THE UGANDA
VIRUS RESEARCH INSTITUTE ON
EMERGING INFECTIOUS DISEASES.
SO, PRIOR TO ANY MAJOR NIH
CONTRACT SOLICITATIONS, THE
SCIENTIFIC CONCEPT MUST BE
APPROVED BY A FEDERAL ADVISORY
COMMITTEE SUCH AS A BSC AND THE
INSTITUTE SENIOR LEADERSHIP.
AND THE CONSIDERATIONS INCLUDE
HERE THE PURPOSE, THE SCOPE, AND
THE OBJECTIVES OF THE CONTRACT.
SO, IN BROAD OUTLINES, WE WANT
TO OBTAIN PERSONNEL AND
SCIENTIFIC SERVICE TO SUPPORT
LABORATORY AND FIELD-BASED
RESEARCH AT THE UGANDA VIRUS
RESEARCH INSTITUTE IN UGANDA AND
FIELD COLLECTION SITES
THROUGHOUT UGANDA.
THIS IS IN ORDER TO SUPPORT ON
GOING RESEARCH COLLABORATIONS
BETWEEN THE LABORATORY OF
VIROLOGY HINES FELDMAN AND
VINCENT MUNSTER IN PARTICULAR
AND THE UVRI ON EMERGING
INFECTIOUS DISEASES.
OTHER LABORATORIES MAY
PARTICIPATE IN THE FUTURE.
SOME OF YOU MAY KNOW THE
LABORATORY OF IMMUNE REGULATION
HAS A PROGRAM THERE WITH TOM
QUINN ALREADY IN UGANDA.
AND THE OBJECTIVE HERE IS TO
SUPPORT THE UGANDA RESEARCHERS
AND RESEARCH SUPPORT STAFF AND
SERVICES WITH RESEARCH SUPPORT
STAFF AND SERVICES REQUIRED TO
FACILITATE APPROPRIATELY
REVIEWED AND APPROVED LABORATORY
AND FIELD BASED STUDIES ON
EMERGING INFECTIOUS DISEASES IN
UGANDA SO WE'RE ASKING FOR YOUR
A APPROVAL AND THIS WILL BE
DETERMINED AT THE DMID
DISCUSSION LATER ON TODAY AND
WE'RE ASKING FOR YOUR APPROVAL
OF THE CONCEPT THAT WE WOULD BE
ABLE TO GO FORWARD WITH THIS.
I'LL STOP THERE AND SAY THANK
YOU, VERY MUCH AND I WILL BE
HAPPY TO TAKE ANY QUESTIONS.
>> ARE THERE ANY QUESTIONS OF
STEVE ON HIS PRESENTATION?
ALL RIGHT.
SEEING NONE, WHAT WE'LL DO RIGHT
NOW, THANK YOU SO MUCH, STEVE.
I APPRECIATE IT.
>> THANK YOU, TONY.
>> Dr. Anthony S. Fauci: SO, WE
WANT TO TAKE A COUPLE OF MINUTE
BREAK.
MATTHEW, SINCE WE'RE DOING THIS
VIRTUALLY, HOW LONG DO WE -- WE
JUST NEED PEOPLE WHO ARE NON
HARE-GOVERNMENT, WE WOULD ASK
THEM TO LEAVE THE ROOM SO WE CAN
MOVE INTO THE CLOSED SESSION