WELCOME, EVERYONE. GOOD MORNING AND
WELCOME TO THE OPEN SESSION OF
THE 210TH MEETING OF THE COUNCIL
OF NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES I'M JEFF
AND CHAIRING TODAY'S OPEN
SESSION. AS YOU KNOW DURING THE
OPEN SESSION OF THE VIRTUAL
MEETING WE ARE JOINED BY
REPRESENTATIVES FROM
PROFESSIONAL AND LAY
ORGANIZATIONS AND PUBLIC WHO
SHARE INTERESTS AND ACTIVITIES
IN COMMON WITH MISSION OF
INSTITUTE AND TODAY AZ MEETING
WILL FOLLOW CONDENSED AGENDA FOR
OPEN SESSION AND FOCUS ON
CONDUCTING COUNCIL BUSINESS AND
COMMENTS WILL BE BRIEF AND WANT
TO ACKNOWLEDGE COUNCIL MEMBERS
AND THANK YOU FOR PARTICIPATION
IN TODAY'S MEETING AND COUNCIL
SERVES CRITICAL ROLE IN
CONTINUING TO MOVE RESEARCH
AGENDA FORWARD.
I WOULD LIKE TO TAKE A COUPLE
MINUTES TO INTRODUCE MYSELF AND
HONORED TO SERVE AS ACTING
DIRECTOR OF NIAID AND CURRENT
INVESTIGATOR IN INTRAMURAL
RESEARCH PROGRAM AND DEPUTY
CHIEF OF LABORATORYIN FERGS
DISEASES IN INTRAMURAL PROGRAM
AND RESEARCH INTERESTS ARE
INFLUENZA VIRUSES AND
DEVELOPMENT OF BROADLY
PROTECTIVE VACCINES AND PRIOR TO
JOINING NIAID IN 2006 I SERVED
AS CHIEF OF DEPARTMENT OF
MOLECULAR PATHOLOGY -- PHD WAS
IN PATHOLOGY AT NAGS 58 CANS
INSTIT
INSTITUTE.
I WILL NOW CALL ON EACH COUNCIL
MEMBER TO INTRODUCE THEMSELVES
AND IDENTIFY WHICH INSTITUTIONS
AND ORGANIZATIONS THEY ARE FROM
AND PROFESSOR ELTRAVAND.
BY :
>> I'M AT UCLA AND INTERESTS IN
HIV PATHOGENESIS AND
PARTICULARLY PREGNANT WOMEN AND
CHILDREN.
>> THANK YOU. I UNDERSTAND
EMILY BROWN IS NOT ABLE TO JOIN
THE OPEN SESSION AND MOVING TO
PROFESSOR ESTEZ.
>> MARY AND AT BAYLOR COLLEGE OF
MEDICINE AND INTERESTED IN
MOLECULAR VIROLOGY FOCUSED ON
GASTROVIRUSES AND HUMAN INGEST
NAL ORGANOIDS.
>> PROFESSOR GURN.
>> HI I'M PROFESSOR OF
PEDIATRICS AT UNIVERSITY OF
MADISON AND INFLUENCE OF
DEVELOPMENT OF CHILDHOOD ASTHMA.
>> PROFESSOR MORAL.
>> GOOD MORNING I'M A PROFESSOR
AND CHAIR OF THE DEPARTMENT OF
MICROBIOLOGY AND IMMUNOLOGY AT
UNIVERSITY OF TEXAS IN SAN
ANTONIO AND IMMUNOLOGIST WORKING
ON LUPUS.
>> PROFESSOR PALMER.
>> GOOD MORNING I'M GUY PALMER
AND PROFESSOR OF GLOBAL HEALTH
AT WASHINGTON STATE UNIVERSITY
AND WORK ON ZOONOTIC INFECTIOUS
DISEASES. THANK YOU.
>> PROFESSOR PASSKWAL.
>> HELLO. I'M A PROFESSOR OF
PEDIATRICS AND DIRECTOR OF
INSTITUTE FOR CHILDREN'S HEALTH
RESEARCH AT CORNELL IN NEW YORK
AND INTERESTED IN STUDY OF
PATHOGENESIS OF PEDIATRIC
AUTOIMMUNE DISEASES.
>> PROFESSOR PUPILS.
>> >> I'M AT VANDERBILT
UNIVERSITY AND PULMONARY
CRITICAL CARE AND STUDY LUNG
INFLAMMATION.
>> THANK YOU. PROFESSOR SHAW?
>> HI, EVERYONE. I'M MS. SHAH
AND AT CHILDREN'S HOSPITAL IN
CHICAGO AT NORTHWESTERN
UNIVERSITY AND RUN THE POLICY
PROGRAM HERE.
>> THANK YOU EXECUTIVE SECT YEAR
OF COUNCIL IS DR. POW.
>> HI I'M DIRECTOR AT NIAD.
>> THANK YOU DR. BAT ACHARI IS
NOT ABLE TO JOIN US BUT DR.
BIGGER STAFF.
>> HELLO SEAN BIGGER STAFF AND
DIRECTOR OF RESEARCH AT DEFENSE
HEALTH AGENCY.
>> THANK YOU. WE ALSO HAVE DR.
EVANS.
>> GOOD MORNING. CHARLES EVANS
RESEARCH SCIENTIST AT DEPARTMENT
OF VETERANS AFFAIRS AND
PROFESSOR AT NORTHWESTERN
UNIVERSITY.
>> DR. JERN ABEGAN FROM THE CDC.
>> I'M DAN DIRECTOR OF NATIONAL
CENTER FOR EMERGING AND ZOONOTIC
DISEASES AT CDC AND SPENT OF
CAREER IN HEALTH INFECTIONS AND
VARIOUS EMERGING AND ZOONOTIC
SYSTEMS.
>> THANK YOU VERY MUCH AND THANK
YOU ALL FOR YOUR PARTICIPATION
IN THIS IMPORTANT EVENT.
COULD I HAVE SLIDE 2, PLEASE?
SO THE AGENDA FOR TODAY, THE
MEETING WILL BEGIN WITH APPROVAL
OF COUNCIL'S OPERATING
PROCEDURES AND FOLLOWED BY
APPROVAL OF NIAID SUFFICIENT
DATA ON REPORT ON INCLUSION OF
WOMEN AND MINORITIES FISCAL YEAR
2022 THROUGH 2024 AND FOUR
CONCEPTS FROM DIVISION OF
MICROBIOLOGY AND INFECTIOUS
DISEASES FOR APPROVAL. NEXT
SLIDE.
THIS IS A SUMMARY OF THE
OPERATING PROCEDURES AND WE WILL
NOW CONTINUE WITH THE AGENDA
WITH MEETING BEGINNING WITH
APROVL OF COUNCIL'S PROCEDURES
IN MAY COUNCIL RECEIVED DOCUMENT
IN FULL IN ELECTRONIC BOOK MAY I
HAVE A MOTION OF COUNCIL
APPROVAL OF OPERATING
PROCEDURES.
>> SO MOVED.
>> IS THERE A SECOND.
>> SECOND.
>> THANK YOU. ALL IN FAVOR OF
OPERATOR PROCEDURES, PLEASE SAY
AYE.
COLLECTIVE: AYE.
>> IT IS APPROVED. NEXT SLIDE.
NEXT ITEM OF BUSINESS IS
APPROVAL OF NIAID SUBMISSION
DATA ON INCLUSION OF WOMEN AND
MINORITIES IN CLIN CAL RESEARCH
FISCAL YEARS 2022 THROUGH 2024
AND JANUARY OF THIS YEAR -- COPY
OF FINAL NIAID FINAL REPORT IS
IN COUNCIL BOOK MAY I HAVE
MOTION FOR APPROVAL OF NIAID
REPORT.
>> SO MOVED.
>> IS THERE A SECOND.
>> SECOND.
>> ALL IN FAVOR OF NIAID REPORT
PLEASE SAY AYE.
>> AYE.
>> ANY OPPOSED? HEARING NONE IT
STANDS AS APPROVED.
NEXT SLIDE. I NOW CALL ON DR.
JOHN ACTING DIRECTOR OF DIVISION
OF MICROBIOLOGY AND INFECTIOUS
DISEASES FOR NEXT PART OF THE
MEETING WITH FOUR CONCEPTS FOR
APPROVAL. DOCTOR, YOU VT FLOOR.
>> GOOD MORNING, EVERYONE. WE
ARE EXCITED WE HAVE FOUR HIGH
PRIORITY CONCEPTS TO PRESENT B
TO THE NIAID COUNCIL. TO BEGIN,
WE -- THERE IS A COUNCIL --
SORRY THERE IS A CONCEPT CALLED
TUBERCULOSIS RESEARCH UNITS IT
IS A CLINICAL TRIAL OF FROM DR.
ROBINSON WHO WILL PRESENT THAT.
>> GOOD MORNING. JOULE OE CAN
YOU PULL UP MY SLIDES? THANK
YOU. I'M IN THE RESPIRATORY
DISEASE BRANCH PRESENTING 2026
CONCEPT TITLED TUBERCULOSIS
RESEARCH UNITS OR TBRUS FOR
SHORT UNDERSTANDING PATHOGENESIS
OF TUBERCULOSIS AND INTERACTIONS
WITH HOST FOR CLINICAL AND
PRECLINICAL STUDIES AND FOCUS IS
CHARACTERIZING ROLES AND
BACTERIAL HOST HETEROGENEITY AND
DISEASE PROGRESSION AND FINDING
BACTERIAL AND HOSTS RELEVANT TO
DISSEMINATION AND DISEASE STAGE.
THIS IS A RENEWAL WE ARE
SHIFTING FROM U19 MECHANISM TO
PO1 MECHANISM AND ANTICIPATE 3
TO 5 AWARDS WITHIN FIRST YEAR
AND FIRST YEAR TOTAL COST OF 10
MILLION DOLLARS.
NEXT SLIDE.
GLOBALLY TB IS LEADING CAUSE OF
DEATH FROM INFECTIOUS DISEASE
AND 202310.8 MILLION NEW TB
CASES 400,000 OF WHICH WERE DRUG
RESISTENT. 1.2 MILLION
INDIVIDUALS DIED OF TB IN 2023
AND FOLLOWING INHALATION OF TB
SOME INDIVIDUALS -- YES?
>> YOU WERE A SLIDE OFF. I WANT
TO MAKE SURE IT LOOKS LIKE
SLIDES HAVE CAUGHT UP WITH YOU.
>> OKAY. THANK YOU. THANK YOU
GIULIO.
FOLLOWING INHALATION OF TB, SOME
INDIVIDUALS ARE CAPABLE OF
ELIMINATING INFECTION THROUGH
INNATE ADAPTIVE IMMUNE RESPONSES
AND THOSE THAT DON'T CLEAR
INFECTION SPECTRUM OF OUTCOMES
OCCUR AND BEST OUTCOME IS LATENT
TB VIABLE BACTERIA ARE PRESENT
IN THE LUNG AND LATENT TB IS NOT
INFECTIOUS AND LETHAL OUTCOME IS
ACTIVE TB OCCURRING WHEN IMMUNE
CONTROL IS COMPROMISED AND
ESCAPES GRANULOMA IN AIRWAYS AND
SPREADING BACTERIA TO OTHERS AND
THIRD OUTCOME THAT WE HAVE
MINIMAL UNDERSTANDING OF SUB
CLINICAL TB OCCURRING WHEN
INDIVIDUALS HAVE PATHOLOGY AND
POTENTIALLY TRANSMIT TB AND
SYMPTOMS IF PRESENT ARE NOT
RECOGNIZED AND INSUFFICIENT TO
SEEK CARE INDICATED BY ARROWS
AND PERSON'S TB STATUS IS NOT
STATIC AND CAN SHIFT DURING LIFE
AND TREATMENT. NEXT SLIDE,
PLEASE.
WE KNOW FROM DECADES OF BASIC
AND CLINICAL RESEARCH THAT
HETEROGENEITY AT PATHOGEN LEVEL
AND HETEROGENEITY AT HOST LEVEL
HAVE ENORMOUS INFLUENCE WHERE
SOMEONE ENDS UP ON TB SPECTRUM
AND PATHOGEN LEVEL DIVERSITY AND
LINEAGE AND DRUG RESISTANCE AND
ABILITY TO SURVIVE AEROSOL
DROPLETS AND DIFFERENT TISSUE
ENVIRONMENTS HOST LEVEL SEX AGE
COMORBIDITIES AND HOST RESPONSE
AS WELL AS HIV STATUS.
NEXT SLIDE, PLEASE.
TB USE IS LONGSTANDING PROGRAM
INSTRUMENTAL IN DEFINING
BACTERIA AND HOST DETERMINANTS
RELEVANT TO TB ESTABLISHMENT AND
DISSEMINATION AND STAGE AND
ENGAGES IN PRECLINICAL AND
CLINICAL STUDIES IMPROVING
KNOWLEDGE OF TB PATHOGENESIS AND
HOST INTERACTIONS AND IN TURN
INFORMS STRATEGIES FOR
PREVENTION AND TREATMENT AND
DETECTION EACH NEEDED TO END TB
PANDEMIC.
NEXT SLIDE THIS SLIDE
ILLUSTRATES HISTORY IN PROGRAM
SINCE IT BEGAN IN 1994 AND FIRST
TBU WAS A CONTRACT AND FOCUSED
ON CLINICAL RESEARCH. 2014 WE
CONVERTED PROGRAM FROM CONTRACT
TO GRANT RECOMMENDED MECHANISM
ENABLING INSTITUTIONS ACROSS THE
US TO APPLY AND PART OF THE
CONVERSION INTRODUCED
REQUIREMENT THAT APPLICANTS
INCLUDE CLINICAL AND ANIMAL
STUDIES AND OTHER FEATURES OF TB
ARE USED PROJECTS INVOLVING TOOL
DEVELOPMENT AND DISCOVERY OF
BACTERIAL BIOMARKERS AND HOST
BIOMARKERS CORRESPONDING WITH
PROGRESSION AND DISEASE
RESISTANCE.
NEXT SLIDE.
4TBRUS EACH BASED AT DOMESTIC
INSTITUTION WITH PROJECTS WITH
BACTERIAL AND HOST DETERMINANTS
OF TREATMENT AND LISTED HERE
UNDER RESPECTIVE INSTITUTION.
AS MENTIONED PREVIOUSLY TBRU
INCORPORATES CLINICAL STUDIES
AND ANIMAL MODEL STUDIES AND
MOST COMMON BEING AEROSOL
INFECTION OF MICE AND CLINICAL
STUDY REQUIREMENT EXISTING TBRU
USE COLLABORATE WITH SEVERAL
COUNTRIES WITH HIGH TB RATES.
NEXT SLIDE, PLEASE.
TBRU ACHIEVEMENTS ADDRESS
OBJECTIVES OF NIAID TB STRATEGIC
PLAN THAT WE UPDATED IN 2024 --
TBRU PUBLICATIONS ADDRESSING
OBJECTIVES PUBLISHED IN PAST FEW
YEARS IN PEER REVIEWED CLINICAL
AND BASIC SCIENCE JOURNALS.
NEXT SLIDE, PLEASE.
REGARDS TO SCOPE EACH TBRU MUST
HAVE MINIMUM OF TWO
INTERDEPENDENT RESEARCH PROJECTS
ONE PROJECT MUST INVOLVE ANIMAL
STUDIES AND ONE INVOLVE CLINICAL
STUDIES EACH TBRU MUST ADDRESS
PERSISTENT AND NEW CHALLENGES IN
TB FIELD AND LIST CHALLENGES
LISTED HERE AND THOSE IN ITALICS
BEING NEWER FOESI WHICH WE KNOW
VERY LITTLE AND IN ALIGNMENT
WITH NIH DIRECTOR'S VISION TO
REDUCE ANIMAL USE AND ENCOURAGE
DEVELOPMENT OF EX-VIVO SYSTEMS
AND SEE STUDIES TO BETTER
UNDERSTAND ROLE OF HIV TB
PROGRESSION.
NEXT SLIDE, PLEASE.
TBRUS WILL EXCLUDE CORRELATES OF
PROTECTION STUDIES AND ANALYSIS
OF VACCINE CANDIDATES COVERED BY
OTHER NIAID PROGRAMS AND
EXCLUDING RESEARCH ON PRIMARY
FOCUS ON EPIDEMIOLOGICAL
STUDIES.
AS DOING NOW TBRUS WILL BE
EXPECTED TO COMMUNICATE WITH
EACH OTHER VIA MONTHLY VIRTU
MEETINGS AND THERE IS NO
INTERNATIONAL SITE REQUIREMENT
AND A SUBSTANTIAL CHANGE TO
PROGRAM FROM CURRENT ITERATION
AND CHANGING FUNDING MECHANISM
FROM U19 TO P01 AND REASON FOR
THIS IS U19'S ENTAIL SUBSTANTIAL
PO INVOLVEMENT IN FINANCIAL
DECISION MAKING AND POS NOT
INVOLVED IN SCIENTIFIC DECISION
MAKING IN TBRUS AND ENERGY WE
EXPECT SHIFTING TO MECHANISM AND
REVIEW OF APPLICATIONS OCCUR AT
CSR IN SPECIAL EMPHASIS PANEL
APART FROM TBRUP01 APPLICATIONS
AROUND SCIENCE BE REPLICABLE AND
REPRODUCIBLE AND CONSIDER RIGOR
OF PRIOR RESEARCH SUPPORTING
APPLICATION.
NEXT SLIDE, PLEASE.
I WOULD LIKE TO THANK COUNCIL
MEMBERS FOR PROVIDING
CONSTRUCTIVE FEEDBACK ON THIS
CONCEPT IN RESPONSE TO THEIR
FEEDBACK WE HAVE DEFINED
SUBCLINICAL TB RESEARCH WE WOULD
LIKE TO ENCOURAGE INVESTIGATION
INTO AND INDICATED HOW TBRUS
COMMUNICATE WITH ONE ANOTHER AND
CLARIFY THERE IS NO LONGER
INTERNATIONAL SITE REQUIREMENT
AND REVIEW OF TBRU APPLICATIONS
OCCUR SEPARATE FROM NON-TBRU
APPLICATIONS.
NEXT AND FINAL SLIDE, PLEASE.
CONCLUDING REQUESTING APPROVAL
OF RENEWAL OF CONCEPT OF FISCAL
YEAR 2026 AND OBJECTIVES OF
LONGSTANDING AND PRODUCTIVE
PROGRAM FUNDAMENTAL KNOWLEDGE TO
UNDERSTAND -- HOST OF
PRECLINICAL AND CLINICAL STUDIES
AND FUNDING MECHANISM SWITCHING
FROM U-19 TO P01 MECHANISM
BETTER REFLECTING DEGREE OF
SYNERGY WE EXPECT APPLICANTS TO
ACHIEVE AND PO INPUT INTO
EXPERIMENTAL DESIGN AND
ANTICIPATE 305 AWARDS TOTAL COST
OF 10 MILLION DOLLARS AND THANK
YOU FOR CONSIDERING REQUESTS AND
HAPPY TO TAKE QUESTIONS.
>> THANK YOU, RICH. THIS
ALREADY HAS BEEN DISCUSSED WITH
SEVERAL COUNCIL MEMBERS AND
COMMENTS HAVE BEEN REVIEWED.
I WON'T CALL ON ANY PARTICULAR
COUNCIL MEMBERS. AT THE TIME I
WILL OPEN IT UP FOR GENERAL
QUESTIONS, COMMENTS FROM THE
FULL NIAID COUNCIL.
HEARING NONE. WE WILL VOTE AT
THE END IN THE COUNCIL BOOK.
PROCEEDING TO THE SECOND CONCEPT
FOR CLEARANCE AND IS A LIMITED
COMPETITION UC-7 FOR SUPPORT OF
NATIONAL BIOCONTAINMENT
LABORATORY FOR SUPPORT AND MR.
WILLIAMS WILL DESCRIBE THIS
CONCEPT.
>> THANK YOU. JULIO, WILL YOU
ADVANCE THE NEXT SLIDE FOR ME?
>> YEAH.
>> OKAY. SO TODAY I WILL
PRESENT CONCEPTS FOR THE
OPERATION SUPPORT OF NATIONAL
BIOCONTAINMENT LABORATORIES OR
NBLS AND IS UNDER UC7 MECHANISM
AND RENEWAL WITH ITS UNLIMITED
COMPETITION AND EXPECTED AWARDS
OF TWO FACILITIES CURRENTLY AT
UNIVERSITY OF TEXAS MEDICAL
BRANCH UTMB OR BOSTON
UNIVERSITY.
NEXT SLIDE.
SO A LITTLE HISTORY AND
BACKGROUND BASED IN 2002 BLUE
RIBBON PANEL, NIAID CONTRIBUTED
SIGNIFICANT FUNDS OF
CONSTRUCTION RENOVATION OF
LABORATORIES THAT INCLUDED 12
REGIONAL BIOCONTAINMENT BSL-3
LABORATORIES SHOWN IN BLUE DOTS
ON BOTTOM RIGHT AND TWO NATIONAL
BIOCONTAINMENT BSL-4
LABORATORIES SHOWN IN RED DOTS
BOSTON UNIVERSITY AT GAL VESTON
AND THEY ARE THE NEEDLES FOR
NATIONAL EMERGING INFECTIOUS
DISEASE LABORATORY AND BSL4
LABORATORIES SUPPORTED BY NIAID
ARE CRITICAL PART OF
INFRASTRUCTURE USED FOR
BIORESEARCH IN SAFE AND
ENVIRONMENT. NEXT SLIDE.
THIS IS A TIMELINE SHOWING THE
AWARDS FOR CONSTRUCTION STARTING
IN 2003 AND CONSTRUCTION
BEGINNING MID-2000S FOR THE
NEEDLE AND GNL AND IN COMBINANT
WITH THAT STARTING UC-7 SUPPORT
PRAITIONAL SUPPORT THAT WAS
CRITICAL FOR MAINTAINING
FUNCTIONALITY OF FACILITIES
PROVIDING SUFFICIENT OPERATIONAL
MECHANICAL REGULATORY BURDEN
ACROSS THESE NEXT YEARS.
NEXT SLIDE, PLEASE.
IMPORTANTLY IN TERMS OF AWARD
FACILITIES WERE TO SUPPORT NIAID
BIODEFENSE AGENDA AND APPROVED
BIOMEDICAL RESEARCH ACTIVITIES
FOR 20 YEARS AFTER OCCUPANCY.
PARTICIPATE IN NBL/RBL NETWORK
THAT INCLUDES NIAID INTRAMURAL
FACILITIES ROCKY MOUNTAIN LABS
AND INTEGRATIVE RESEARCH
FACILITY AND BE PREPARED TO
ASSIST IN NATIONAL LOCAL PUBLIC
HEALTH EFFORTS IN EVENTS OF
EMERGENCY. NEXT SLIDE.
SO THIS GIVES YOU SORT OF THE
OPERATION SUPPORT SCOPE. SCOPE
OF THE COVERAGE AND GEARS ON THE
RIGHT AND COLOR GEARS INDICATE
DIFFERENT CORES OF THE UC-7
FUNDING.
FOCUSING MAINLY IN THE LARGE BOX
FACILITY MAINTENANCE AND
OPERATION AND OPERATIONAL
MANAGEMENT MONITORING
CERTIFICATIONS AND PREVENTIVE
NONROUTINE MAINTENANCE BSL-4
EQUIPMENT AND SYSTEMS AND
IMPORTANT COMPONENT IS
BIOSECURITY AND BIOSAFETY
COMPLIANCE ASSOCIATED WITH
SELECTIVE AGENT WORK AND BSL-4
PATHOGENS ARE SELECTIVE AGENTS
AND IMPORTANTLY PRACTICES AND
TRAINING CERTIFICATIONS FOR ALL
STAFF THAT WORK IN THE
LABORATORIES.
YOU ALSO SEE ENVIRONMENTAL
HEALTH AND SAFETY EHS
REQUIREMENTS AND REGULATORY
COMPLIANCE IMPORTANT FOR
SUBMISSION OF PRODUCT
DEVELOPMENT AND DEVELOPMENT
SUPPORTING PRODUCT DEVELOPMENT
IN SUBMISSIONS TO REGULATORY
AGENCIES.
THEN FINALLY THE INTEGRATIVE
SUPPORT SERVICES IN THE LIGHT
BLUE SUPPORTING DIFFERENT
ACTIVITIES VETERINARY IMAGING
AND DEPENDING ON SPECIALTIES AND
EXPERTISE WITHIN THE FACILITIES.
TWO IMPORTANT POINTS AT THE
BOTTOM AND BOTTOM BULLET THAT
DOES NOT DIRECTLY SUPPORT
CONDUCTIVE RESEARCH THAT IS ONLY
THE OPERATIONS AND STAFF.
AND THE EXPECTATION IS THAT THE
NBLS ARE GOING TO RECEIVE ALSO
ADDITIONAL OPERATIONAL SUPPORT
FROM BOTH INSTITUTIONS AND OTHER
OUTSIDE SOURCES.
NEXT SLIDE, PLEASE.
THIS IS A PICTURE OF THE TWO
LABORATORIES, GNL AND NEEDLE
SEEING FROM DOLLARS THAT NIAID
SUPPORTED MAJORITY OF
CONSTRUCTION COSTS FOR BOTH
FACILITIES AND ON RIGHT IN THE
GREEN BOX CAPABILITIES I ELUDED
TO IN TERMS OF IMMUNOLOGIST AND
MODEL DEVELOPMENT AND
NON-CLINICAL GLP STUDIES AND
IMPORTANTLY LAST -- YOU KNOW,
LAST BULLET IS, YOU KNOW, THERE
IS A REALLY STRONG STAFF AND
FACULTY WITHIN THESE
INSTITUTIONS DRIVING INDEPENDENT
RESEARCH PROGRAMS AND ALLOW
FACILITY TO SERVE AS CONTRACTORS
FOR NIAID AND PRECLINICAL
SERVICES COLLABORATING WITH
VARIETY OF OUTSIDE
ORGANIZATIONSACDEMIA AND
INDUSTRY AND INCLUDING
NON-GOVERNMENTAL ORGANIZATIONS
AND OTHER GOVERNMENT FUNDING
OPPORTUNITIES.
NEXT SLIDE.
SO THIS SLIDE GIVES YOU A SORT
OF OVERVIEW AND TOUCH OF SOME
DIFFERENT ACCOMPLISHMENTS
RECENTLY AND FOCUSES ON GNL.
YOU CAN SEE, YOU KNOW, A LOT OF
DIFFERENT VIRUSES AND PATHOGENS,
NIPA AND HEMOAGIC FEVER AND
CONGO AND BREADTH OF DIFFERENT
PATHOGENS THEY ARE ABLE TO
ADDRESS IN TERNLS OF
FUNCTIONALITY AND IF YOU LOOK
YOU WILL SEE MONOCLONAL
ANTIBODIES AND SMALL ANIMALS AND
VACCINES AND DIFFERENT MEDICAL
COUNTERMEASURES ABLE TO ADVANCE
RESEARCH AND DEVELOPMENT FOR.
NEXT SLIDE, PLEASE.
SIMILARLY FOR NEEDLE, YOU SEE
BROAD RANGE OF RNA VIRUSES AND
HEN EPA VIRUSES AND EBOLA
VIRUSES.
IN THIS SLIDE ALSO INDICATES
SOME BASIC RESEARCH AND SOME
UPPER LEFT ONE AND PROCEDURES
FOR DECONTAMINATION AND VIRAL
INACTIVATION AND MIDDLE ONE,
METHODOLOGIES FOR IMAGING
PLATFORM HIGHLIGHT ADVANCEMENTS
THAT EXPERTISE AT FACILITIES ARE
ABLE TO ENGENDER AND MOVE
FORWARD.
NEXT SLIDE.
SO WE HAVE HELPFUL COMMENTS FROM
COUNCIL MEMBERS BACK IN JANUARY.
HIGHLY SUPPORTIVE BECAUSE THE
OPERATIONS AND CAPABILITIES AND
AVAILABILITY OF FACILITIES ARE
REALLY CRITICAL FOR US TO BE
ABLE TO CONDUCT BIODEFENSE
RESEARCH IN SAFE AND SECURE
ENVIRONMENT AND IT IS REALLY
CONSIDERITY KALE THAT MBA FOSTER
COLLABORATIONS WITH EXTERNAL
PARTNERS OF DIFFERENT SHAPES AND
SIZES PHARMACONTRACT RESEARCH
ORGANIZATIONS
NON-GOVERNMENTALMENTAL
ORGANIZATIONS, ET CETERA AND
IMPORTANTLY COORDINATE AND SHARE
BEST PRACTICES THROUGH THIS
NETWORK THAT SERVES AS GREAT WAY
FOR INTERACTING AND SHARING BEST
PRACTICES AND INFORMATION ACROSS
BSL-4 LABORATORIES AND INCLUDING
ROCKY MOUNTAIN LABS, IRF AND
TEXAS RESEARCH BIOMEDICAL
INSTITUTE AND CRITICAL THAT
INSTITUTIONS AND FACILITY ITSELF
WORKS TO BRING IN EXTRA FUNDS IN
ADDITION TO THE SUPPORT THAT WE
PROVIDE. FUNDING THAT CUC7
PROVIDES DOESN'T COVER ENTIRETY
OF COSTS OF OPERATIONS OF BSL-4S
AND REQUIREMENT AND EXPECTATION
THEY WILL BRING IN ADDITIONAL
FUNDS BY DIFFERENT PATHS.
LAST SLIDE REITERATES CONCEPT
AND UC-SERVE LIMITED COMPETITION
FOR TWO AWARDS. THANK YOU. CAN
TAKE QUESTIONS.
>> SEVERAL MEMBERS AND COMMENTS
HAVE BEEN INCORPORATED INTO THE
CONCEPT. AT THIS TIME, I WILL
OPEN IT FOR GENERAL QUESTIONS OR
COMMENTS FROM THE FULL NIAID
COUNCIL. OKAY. THEN AGAIN WE
WILL VOTE IN COUNCIL BOOK AT THE
END.
I WILL MOVE TO THE NEXT WHICH IS
PARTNERSHIPS FOR DEVELOPMENT OF
VACCINES TO PREVENT
MICROBACTERIUM TUBERCULOSIS
INFECTION AND IR1 AND MR.
EICHOLBERG WILL PRESENT.
IKE EL EICHEL
.
>> I'M KATRIN EICHELBERG AND
PARTNERSHIP FOR DEVELOPMENT OF
VACCINES TO PREVENT
MICROBACTERIUM TUBERCULOSIS
INFECTION AND/OR DISEASE AND
OBJECTIVE OF CONCEPT IS
SUPPORTING RESEARCH APPLICATIONS
FOR OBJECTIVE-DRIVEN PROJECT
FOCUSED ON PRECLINICAL
DEVELOPMENT OF LEAD CANDIDATE
VACCINES TO PREVENT INFECTION OR
DISEASE TO INCREASE CLINICAL
PIPELINE OF VIABLE VACCINE
CANDIDATES A NEW PROGRAM
CO-SPONSORED BY DMID IN DIVISION
OF AIDS AND MECHANISM WE PROPOSE
IS R01 MECHANISM.
TB CONTINUES TO BE A LEADING
INFECTIOUS DISEASE KILLER AND
DESPITE THE FACT THAT TB IS
FAIRLY TREATABLE, GLOBALLY CLOSE
TO 3,500 PEOPLE DAY EVERY DAY OF
TB.
TB INCIDENTS RATES IN THE US ARE
CURRENTLY AT HIGHEST RATES IN
PAST DECADE WITH CLOSE TO 10,000
TB CASES REPORTED IN 2023.
A COUPLE OF YEARS AGO, THE WHO
COMMISSIONED AN INVESTMENT
ANALYSIS FOR NEW TB VACCINES AND
REPORT PREDICTED A HIGH RETURN
OF INVESTMENT WITH ABILITY OF A
NEW AND EFFECTIVE VACCINE BEING
ABLE TO AVERT MILLIONS OF CASES
OF DISEASE AND DEATH AS WELL AS
HAVING A SIGNIFICANT DOWNSTREAM
ECONOMIC IMPACT.
CURRENTLY, OUR ONLY LICENSED
VACCINE IS BCG THAT HAS BEEN
GIVEN TO INFANTS FOR MANY YEARS.
ONLY LICENSED VACCINE IN OVER
100 YEARS.
AND IT HELPS BCG IS EFFECTIVE IN
PREVENTING DISSEMINATED DISEASE
IN INFANTS HOWEVER IS NOT
PROTECTIVE IN INVENTING
PULMONARY DISEASE IN ADOLESCENTS
AND ADULTS AND SLIDE SHOWS
CURRENT GLOBAL ACTIVE CLINICAL
TB VACCINE PIPELINE ORGANIZED
HERE BY DIFFERENT PHASES OF
CLINICAL TRIALS AND YOU SEE
DIFFERENT CANDIDATES LISTED THAT
ARE CURRENTLY UNDER
INVESTIGATION.
THESE CANDIDATES REPRESENT
DIFFERENT VACCINE APPROACHES AND
DIFFERENT PLATFORMS AND
INDICATIONS AND DIFFERENT
POPULATIONS AND WHERE IT IS
BEING STUDIED AS WELL AS
DIFFERENT ANTIGENIC
COMPOSITIONS.
WHAT I WOULD LIKE TO POINT OUT
HERE TWO ASPECTS THAT ARE
NOTEWORTHY IS, ONE, IT IS A
FAIRLY SMALL PIPELINE FOR SUCH
AN IMPORTANT PATHOGEN.
SECONDLY, IT IS AN INVERTED
PIPELINE.
WHAT I MEAN IS YOU HAVE VERY FEW
CANDIDATES HERE IN THE PHASE I
AND PHASE I OF CLINICAL TRIALS
AND TYPICALLY YOU SEE FOR OTHER
VACCINE LANDSCAPES YOU SEE A
LARGER LIST OF CANDIDATES IN
PHASE I THAT DROP OUT AS
CLINICAL DEVELOPMENT PROCEEDS.
REALLY, GOAL OF THE CONCEPT IS
TO DEVELOP NEW TB VACCINE
CANDIDATES THAT COULD ENTER
PHASE I CLINICAL TRIALS.
ALL RIGHT. WE HAD IN 2018 A
SIMILAR PROGRAM, A PRIOR TB
PARTNERSHIP PROGRAM AND SUPPORT
OF DESIGN AND DEVELOPMENT OF
VARIOUS VACCINE PLATFORMS AND
APPROACHES WITH MULTIPLE
DIFFERENT IMMUNOGENS AND
SUPPORTED FIVE APPLICATIONS AND
DIFFERENT APPROACHES THAT WERE
INVESTIGATED AND SUPPORTED BY
THIS PREVIOUS PARTNERSHIP
PROGRAM LISTED HERE IN THE BOX.
REPRESENTING DIFFERENT PLATFORMS
AND, AGAIN, ANTIGENIC
COMPOSITIONS AND VACCINE SHOWING
PROMISING IMMUNOGENISTY AND
PROTECTION IN RELEVANT ANIMAL
MODELS POINTING OUT ONE VACCINE
CANDIDATE HERE THAT IS A VACCINE
H107CAF10-B AND CANDIDATE SHOWED
PROMISING PRECLINICAL DATA
HAVING UNIQUE TH1 AND T17
SIGNATURE THAT IS PROTECTIVE IN
PRECLINICAL MODELS AND GATES
FOUNDATION IS CURRENTLY
SUPPORTING PHASE 1 CLINICAL
TRIAL.
AND IT IS ONGOING AS WE SPEAK.
SO SCOPE OF THE NEW FY26 CONCEPT
IS THE FOLLOWING.
AS I SAID, WE HAD A PRIOR
PROGRAM THAT FOCUSED MORE ON THE
DESIGN AND LESS SO ON FURTHER
PRECLINICAL DEVELOPMENT OF
CANDIDATES.
WHAT WE ARE FOCUSING HERE ON IS
PRECLINICAL DEVELOPMENT OF NEW
CANDIDATES, AGAIN, WITH THE GOAL
OF FEEDING THE PHASE I CLINICAL
TRIAL PIPELINE.
ACTIVITIES, WE ANTICIPATE
SUPPORTING OPTIMIZATION OF LEAD
CANDIDATES AND OPTIMIZATION OF
DOSE AND [INDISCERNIBLE] OF
DELIVERY PRECLINICAL AND PRODUCT
DEVELOPMENT ACTIVITIES THAT
INCLUDE SAFETY TOXICITY AND
FURTHER EFFICACY STUDIES.
FURTHERMORE OPTIMIZATION AND
PRODUCTION AND METHODOLOGY AND
PROCESS DEVELOPMENT AND IF
CANDIDATE IS FURTHER DEVELOPED
MANUFACTURING ACTIVITIES ALSO.
THIS PROGRAM, PARTNERSHIP
PROGRAM, DMID PARTNERSHIP
PROGRAM HAS TWO UNIQUE ASPECTS.
ONE OF WHICH IS INDUSTRY
PARTICIPATION IS REQUIRED.
THIS PARTICIPATION COULD BE ON
DIFFERENT LEVELS, CONSULTATION
AND DIRECT DEVELOPMENT OF
INVOLVEMENT AND PHARMACEUTICAL
INDUSTRY BIOTECH OR NON-PROFIT
ORGANIZATION THAT HAS A PROVEN
TRACK RECORD OF VACCINE PRODUCT
DEVELOPMENT AND UNIQUE ASPECT TO
PARTNERSHIP PROGRAM, AS I SAID,
IT IS AN OBJECTIVE DRIVEN R01
MECHANISM BESIDES REGULAR
12-PAGE RESEARCH STRATEGY THAT
YOU FIND IN R0-1 APPLICATIONS
STATES ALSO PRODUCT DEVELOPMENT
STRATEGY SECTION IN ADDITION TO
RESEARCH PLAN.
AND THIS STRATEGY WILL OUTLINE A
PRODUCT DEVELOPMENT PLAN AS WELL
AS TIMELINES AND OBJECTIVES
DESCRIBING ACTIVITIES IN MORE
DETAIL THAN I JUST LISTED HERE.
I WOULD LIKE TO THANK COUNCIL
MEMBERS, DR. TAYLOR AND PALMER
FOR PROVIDING CONSTRUCTIVE
FEEDBACK TO THIS CONCEPT AND
THEY ADDRESS A CRITICAL NEED FOR
VACCINES AND EFFECTIVE NEW TB
VACCINE WOULD NOT ONLY BE A
GREAT ADDITION TO GLOBAL HEALTH
AND SAFEGUARD U.S. CITIZENS AND
QUESTIONS THAT CAME UP DURING
THE DISCUSSION I JUST OUTLINED
IN THE PRESENTATION.
IN CLOSING, AGAIN, THIS CONCEPT
OBJECTIVE HERE OF THIS CONCEPT
IS TO SUPPORT RESEARCH
APPLICATIONS FOR
OBJECTIVE-DRIVEN PROJECTS
FOCUSED ON PRECLINICAL
DEVELOPMENT OF LEAD CANDIDATE
VACCINES PREVENTING TB INFECTION
OR DISEASE INCREASING CLINICAL
PIPELINE OF VIABLE VACCINE
CANDIDATES NEW PROGRAM FOLLOWING
OBJECTIVE DRIVEN R01 MECHANISM
WITH ESTIMATED TOTAL HERE COST
OF 4.7 MILLION DOLLARS BY DMIT
AND DIVISION OF AIDS ANTICIPATE
TO MAKE 3 TO 5 AWARDS.
>> THANK YOU. AGAIN, SINCE
COUNCIL HAS ALREADY SEEN THIS
AND SOME COUNCIL MEMBERS HAVE
SEEN WHAT HAS BEEN INCORPORATED
OPENING UP FOR BROAD ER COUNCIL
FOR COMMENTS AND QUESTIONS.
HEARING NONE, WE WILL MOVE TO
THE LAST CONCEPT FOR REVIEW.
THIS SAY CONCEPT INFLUENCE
TRANSMISSION RESEARCH
CONSORTIUM, P01 ON DR. BROOK
BAZIK FROM RESPIRATORY DISEASE
WILL PRESENT THIS.
>> THANK YOU FOR HAVING ME AND
LIKE JOHN SAID I WILL PRESENT
CONCEPT FOR INFLUENZA
TRANSMISSION RESEARCH
CONSORTIUM.
NEXT SLIDE.
THIS INITIATIVE WILL ESTABLISH
INFLUENZA TRANSMISSION RESEARCH
CONSORT NUMB WITH PROCESS OF
HUMAN TO HUMAN TRANSMISSION AND
PROPOSING P01 MECHANISM WITH
FIRST YEAR AWARDS OF 2 TO 3 AND
OF 8 MILLION DOLLARS.
A LITTLE BACKGROUND ON
TRANSMISSION PROCESS FOR
RESPIRATORY VIRUSES THREE MODES
MAIN CONTACT TRANSMISSION AND
THROUGH LARGE DROPLETS AND
AEROSOL TRANSMISSION.
[INDISCERNIBLE] WITH
CONTAMINATED SURFACES AND
DEPENDING ON SURFACE TYPE
PARTICLES CAN REMAIN INFECTIOUS
FOR UP TO 48 HOURS AND -- LARGE
DROPLETS SETTLE QUICKLY AND
THOUGHTS BE IMPORTANT FOR CLOSE
RANGE TRANSMISSION AND SUSPENDED
NEARLY HOURS TRANSMITTED FAIRLY
LONG DISTANCES AIDED BY
VENTILATION AND AIR FLOW AND
ONGOING DEBATE IN FIELD
APPROPRIATE CUTOFF SIZE LARGE
DROPLETS VERSUS AEROSOLS AND
CUTOFF OF TB DATA IN 1940S AND
RECENT WORK SUGGESTING IT SHOULD
BE HIGHER 30 TO 100 MAKE CONS
AND WHOLE OTHER SCHOOL OF
THOUGHT SAYING PARTICLE SIZE IS
CONTINUUM AND SHOULDN'T BE HUNG
UP ON HOW SIZE EFFECTS AIRBORNE
SUSPENSION BUT THINK WHERE
PARTICLES CAN DEPOSIT IN HOST
AND LARGE DROPLETS IN NASAL
CAVITY AND GO TO LUNGS AND CAUSE
MORE SEVERE DISEASE.
NEXT SLIDE.
IN ADDITION, IN ADDITION TO
VARIOUS MODES OF TRANSMISSION,
THERE ARE HOST VIRAL AND
ENVIRONMENTAL FACTORS
INTERACTIVE TO SUCCESSFUL
TRANSMISSION OCCURS AND
VACCINATION STATUS AGE GENETICS
BEHAVIOR AND INFLUENCE
SUSCEPTIBILITY AND ABILITY TO
SHED VIRUS ENVIRONMENTAL FACTORS
TEMPERATURE AND RELATIVE HUME
TID EFFECT HOW THIS VIRUS CAN
SURVIVE IN ENVIRONMENT AND VIRAL
FACTORS SERVICE PROTEIN AND
MORPH OWE WILLING AND PARTICLE
CAN INFECT A HOST AND TISSUE
TROPHISM AND VIRUS EFFECTS
ANATOMICAL SITE LEADING TO
TRANSMISSION.
NEXT SLIDE.
WITH FRAMEWORK IN MIND WE CAN
START TO MAP MAJOR GAPS IN
KNOWLEDGE OF TRANSITION PROCESS
AND FOR EXAMPLE WE DON'T
UNDERSTAND RELATIVE CONTRIBUTION
OF MODES OF TRANSMISSION IN
DIFFERENT SETTINGS AND
INFECTIOUS VIRUS IS COVERED BY
DROPLETS OR AEROSOLS AND HOST
DRIVEN FACTORS DON'T HAVE
UNDERSTANDING WHETHER
SYMPTOMATIC DISEASE AND HIGH
VIRAL SHEDDING LEAD TO
TRANSMISSION AND PHYSIOLOGICAL
GENETIC AND BEHAVIORAL FACTORS
AND DISPOSE AND EFFECT
TRANSMISSION OF FLU AND
COLONIZATION OR SHEDDING THERE
ARE ENVIRONMENTAL FACTORS
IMPACTING WHERE AND WHEN
TRANSMISSION CAN OCCUR AND GIVEN
SIGNIFICANT GAPS THERE IS NEED
FOR WORK IN THIS AREA AND TUNE
TIME THERE IS INTEREST IN
RESPIRATORY VIRUS TRANSMISSION
IN GENERAL OVER PAST COUPLE
YEARS FOLLOWING EMERGENCE OF
SARS COV-2 AND INFLUENZA STRAT
EEJ PLAINING AND RESEARCH AREA 1
AND OBJECTIVE 1 AND NEXT SLIDE.
THIS IS A RENEWAL OF INITIATIVE
WE PUT FORWARD IN FISCAL YEAR
2021 AND INITIATIVE FACED
SIGNIFICANT CHALLENGES WE
LEARNED FROM. THAT RFA CALLED
FOR BASIC RESEARCH AND FLU
TRANSMISSION BY
MULTI-DISCIPLINARY TEAMS THAT IS
DESCRIPTIVE REQUIRING PROGRAMS
TO PROPOSE DEVELOPMENT OF DEVICE
FOR SAMPLING AIRBORNE PARTICLES
AND NOVEL ASSAY VIABILITY OF
PARTICLES IN ADDITION TO
PERFORMING COMPREHENSIVE
RESEARCH PROJECTS FINDING BIT OF
DISCONNECT BETWEEN STATE OF
SCIENCE AND RFA REQUIREMENTS
SPECIFICALLY REGARDING
TECHNOLOGY DEVELOPMENT AND
TIMELINES FINDING A MAJOR
CHALLENGE TO DEVELOP INNOVATIVE
DEVICES AND ASSAYS INTEGRATING
THEM IN RESEARCH IN FIVE YEARS
ESPECIALLY IF TECHNOLOGY IS
NOVEL AND NO PROTOTYPES
DEVELOPED AND MAJOR CHALLENGE NO
ONE COULD HAVE FORESEEN IS RFA
WAS PUBLISHED AND AWARDED DURING
HEIGHT OF COVID PANDEMIC LED TO
HURDLES FOR ANY AWARD AT THAT
TIME AND WASN'T FLU SEASON FOR
FIRST TWO YEARS FOLLOWING
OUTBREAK. FROM 2020 TO 2022
THERE WASN'T FLU CIRCULATION AND
FINALLY SINCE RFA WENT OUT IN
MIDDLE OF PANDEMIC CAUSE FROM
COMMUNITY AT TIME INCORPORATING
SARS COV2 AT CENTERS AND AT THIS
TIME AND KNEW THERE WASN'T GOING
TO BE FLU SEASON DIDN'T WANT
COVID TO SWAMP OUT FLU WORK.
NEXT SLIDE.
TAKING LESSONS INTO
CONSIDERATION WHEN DESIGNING NEW
INITIATIVE PROPOSING P01 FOR
RENEWAL AND ACCOMMODATING
COMPREHENSIVE STUDIES AND
RESOURCE DEVELOPMENT THAT WILL
BE REQUIRED REQUIRING CENTERS TO
INCLUDE 2 AND NO MORE THAN THREE
RESEARCH PROJECTS ADMINISTRATIVE
CORE AND THIS TIME AROUND
RESOURCE CORE TO DEVELOP TOOLS
FOR COMMUNITY TO INVESTIGATE
TRANSMISSION AND WILL BE
FLEXIBLE TO ALLOW TEAMS TO
PROPOSE DEVELOPMENT OF RESOURCE
WITHIN SPECIFIC STRENGTHS AND
EXPERTISE AND INCLUDE DEVICES
AND ASSAYS OR BE NEW LIKE ANIMAL
MODELS AND EXPERIMENTAL SETUP
AND COMPUTATIONAL MODELS AND
IMPROVEMENTS TO EXISTING
RESOURCES WOULD BE ALLOWED AND
IMPROVE 789S MORE INCREMENTAL
AND OTHERS COULD BE INCLUDED
BASED ON THAT SPECIFIC CENTER'S
NEEDS AND INTERESTS AND
PATHOGENS LIKE FLU WE ALLOW
CENTERS TO CONDUCT COMPARATIVE
STUDIES WITH HUMAN SEASONAL
RESPIRATORY PATHOGENS SO LONG AS
CENTER STAYS ON FLU AND WANT
PROGRAM TO FUNCTION AS
COLLABORATIVE NETWORK PROPOSING
BUILDING IN CAVEATS TO RFA AND
MEETINGS AND WEBINARS TO SHARE
FINDINGS AND WORKING GROUPS WITH
TOPICS BASED ON THEMES THAT
CENTERS ARE AWARDED. NEXT
SLIDE.
SCOPE OF INITIATIVE WOULD BE
LIMITED TO INFLUENZA AND
SEASONAL HUMAN RESPIRATORY
VIRUSES.
IMPORTANTLY PROGRAMS NEED TO
FOCUS ON HUMAN TO HUMAN
TRANSMISSION OF FLU AND ANIMAL
MODELS RECAPITULATE THIS SCOPE
AND [INDISCERNIBLE] ANIMAL HUMAN
INTERFACE AND FOR PROGRAMS GOAL
IS TO UNDERSTAND DYNAMICS AND
DRIVERS OF FLU TRANSMISSIONS
WHILE LOOKING AT THINGS LIKE
PREVENTION STRATEGIES WOULD BE
ALLOWED WE DON'T WANT FOCUS OF
CENTERS TO BE ON DESIGN,
IMPLEMENTATION OR PRODUCT
DEVELOPMENT AND WITH RFA WE ARE
TRYING TO UNDERSTAND
TRANSMISSION BEFORE WE ATTEMPT
TO STOP IT.
WE RECOGNIZE THAT BEHAVIORAL
INTERVENTIONS COULD BE A USEFUL
TOOL FOR STUDYING TRANSMISSION
IN DIFFERENT SETTINGS RFA
ALLOWING CLINICAL TRIALS
PHARMACEUTICAL INTERVENTIONS NO
CLINICAL TRIALS INVOLVING
PHARMACEUTICALS VACCINES
THERAPEUTICS BIOLOGICS .
NEXT SLIDE
WE WOULD LIKE TO THANK COUNCIL
MEMBERS FOR REVIEWING THIS
CONCEPT AND PROVIDING FEEDBACK
AND BOTH THOUGHT IT WAS A HIGH
PRIORITY AREA OF RESEARCH
THINKING IT WOULD BE IMPORTANT
TO ASSEMBLE MULTI-DISCIPLINARY
TEAMS TO ACCOMPLISH GOALS THAT
THEY RECOMMENDED CLARIFYING HERE
INITIATIVE STRUCTURED AS P01 IS
SEPARATE OPPORTUNITY AS PARENT
R0 ONE WITH REQUIREMENTS
DEDICATED REVIEW AND SET ASIDE
FUNDS.
NEXT SLIDE.
WITH THAT THANKS FOR THE CHANCE
TO PRESENT THIS CONCEPT AND
HAPPY TO TAKE ANY QUESTIONS.
>> THANK YOU, BURT. ANY
QUESTIONS ON CONCEPT OF
INFLUENCE AND TRANSMISSION
RESEARCH CONSORTIUM?
ALL RIGHT. WHAT YOU HEARD IS WE
HAVE FOUR HIGH PRIORITY CONCEPTS
WE THINK ARE SIGNIFICANT AND
SIGNIFICANT POTENTIAL TO ADVANCE
THE FIELD AND SUPPORT THE FIELD.
AND AT THIS TIME, IF WILL IS NO
FURTHER QUESTIONS ON ANY OF
THOSE, WE WOULD ASK THAT THE
COUNCIL VOTE IN THEIR ELECTRONIC
COUNCIL BOOK.
NOW DEFERRING TO DEA COLLEAGUES
TO MONITOR PROGRESS THERE.
>> THANK YOU. WE ARE MONITORING
AND VOTES ARE COMING IN AND GIVE
US A FEW MINUTES WHILE COUNCIL
MEMBERS VOTE.
DR. ESTEZ AND PEEBLES WE ARE
MISSING YOUR VOTES. ARE YOU
VOTING OKAY?
>> I THOUGHT I VOTED.
>> I GOT KICKED OUT AND HAVEN'T
LOGGED BACK IN. SORRY.
>> I MIGHT HAVE TO LOG BACK IN
TOO.
>> THAT IS OKAY. SOMETIMES THE
SYSTEM DOES KICK YOU OUT. IT
TIMES OUT.
>> YOU SHOULD HAVE MY VOTE.
>> THANK YOU. WE HAVE THEM ALL
NOW. DR. TAUBEN BERGER, WE CAN
PULL YOUR SLIDES UP AND PROCEED
WITH THE END, THANK YOU.
>> THANK YOU SO MUCH. THANK YOU
JOHN AND DMID COLLEAGUES FOR
PRESENTING CONCEPTS AND GRATEFUL
TO THE COUNCIL FOR CONSIDERATION
OF THE CONCEPTS BEFORE WE
PROCEED TO NEXT TWO ITEMS ON
AGENDA WE HAVE RECEIVED A
WRITTEN COMMENT FROM JESSICA AND
JARED WITH PHYSICIANS COMMITTEE
OF FULL RESPONSIBLE MEDICINE AND
COMMENT INCLUDES RECOMMENDATIONS
THAT INSTITUTE PRIORITIZE
DEVELOPMENT AND USE OF
HUMAN-BASED -- FULL COMMENT WILL
BE INCLUDED IN THE ELECTRONIC
COUNCIL BOOK AND COUNCIL
MINUTES.
SO OUR NEXT COUNCIL MEETING IS
PLANNED FOR SEPTEMBER AND WILL
INCLUDE OPENED AND CLOSED
SESSION AS HHS AND NIH POLICIES
PERMIT AND ADDITIONAL
INFORMATION ABOUT THE MEETING
WILL BE PROVIDED SHORTLY.
NEXT SLIDE, PLEASE.
SO AT THIS POINT I WOULD LIKE
TO, AGAIN, THANK COUNCIL MEMBERS
FOR PARTICIPATING IN THE OPEN
SESSION OF THE COUNCIL AND PLAN
TO SEE ALL OF YOU WHEN WE
RECONVENE IN SEPTEMBER AND I'M
ADJOURNING THIS COUNCIL MEETING
AT THIS TIME. THANK YOU SO
MUCH.
>> THANK YOU.