WELCOME ALL OF YOU BACK FOR DAY
TWO OF OUR VIRTUAL 179th
MEETING AT THE NICHD ADVISORY
COUNCIL.
FIRST I WILL TURN OVER TO MAGGIE
TO GO OVER THE STATEMENT OF
UNDERSTANDING.
THAT BEEN 1st.
A REMINDER, THE FIRST HOUR AND A
QUARTER IS OPEN AND THEN WE'LL
CONVERT TO A CLOSED MEETING SO
MAGGIE, OVER TO YOU.
THERE YOU ARE.
>> YES, HERE I AM.
GOOD AFTERNOON, MY NAME IS
MAGGIE YOUNG, I'M CHIEF GRANTS
MANAGEMENT OFFICER OF NICHD
BRANCH MANAGEMENT BRANCH AND
GILL OVER THE 2022 STATEMENT OF
UNDERSTANDING.
EACH YEAR WE ASK FOR YOUR
APPROVAL OF THE NICHD STATEMENT
OF UNDERSTANDING WHICH OUTLINES
THE GENERAL PROCEDURE TO BE USE
FORD SECOND LEFT.
THE STATEMENT OF UNDERSTANDING
ADDRESSES THE FOLLOWING:
COUNCIL MEMBERSHIP AND
STRUCTURE.
PROCEDURES FOR SECONDARY REVIEW
OF GRANT APPLICATIONS DURING THE
CLOSED SESSION.
ADMINISTRATIVE DECISIONS AND
ACTIONS THAT DO NOT REQUIRE
COUNCIL RECOMMENDATION.
VOTING OPTIONS AVAILABLE TO THE
COUNCIL.
EXPEDITED REVIEW OF HIGHLY
MERITORIOUS APPLICATIONS.
INTER.
ARE YOU REVIEW MEETINGS.
PROCEDURES FOR CONCEPT CLEARANCE
DURING OPEN SESSION.
EMERGENCY PROCEDURES.
ONLINE TEXT IN THE STATEMENT OF
UNDERSTANDING WAS PROVIDED TO
YOU PRIOR TO THE MEETING AND MAY
ALSO BE VIEWED NOW ON THE
COUNCILMEMBER WEBSITE.
ARE THERE ANY QUESTIONS ABOUT
THE STATEMENT OF UNDERSTANDING?
>> THANK YOU, MAGGIE.
IF THERE ARE NO QUESTIONS, AT
THIS TIME, MAY I HAVE A MOTION
TO APPROVE THE STATE OF
UNDERSTANDING.
>> I MAKE A MOTION TO APPROVE
THE STATEMENT OF UNDERSTANDING.
>> THANK YOU.
MAY YOU HAVE A SECOND?
>> SECOND.
>> OKAY.
PLEASE VOTE ON YOUR ZOOM SCREEN
FOR OR AGAINST OR ABSTAIN USING
THE BUTTONS AT THE BOTTOM OF THE
SCREEN.
>> I'M SHOWING 1 14 QUESTIONS.
>> OKAY, I THINK THAT'S PROBABLY
WHAT WE HAVE.
>> THANK YOU.
AIL NOW TURN THE FLOOR BACK OVER
TO DR. BIANCHI.
>> THANK YOU, DENNIS.
NEXT WE WOULD LIKE TO FOLLOW UP
ON A QUESTION RAISED YESTERDAY
BY DR. AKITA AFTER ALEXIS
CLARK'S EXCELLENT PRESENTATION
ON THE BUDGET.
ASKED HOW MUCH OF THE BUDGET IS
CURRENTLY SPENT ON NETWORKS AND
CENTERS SO I'M GOING TO ASK
ALEXUS, CAN YOU PLEASE SHARE
WHAT YOU DID LAST NIGHT AND WHAT
YOU FOUND SUIT IN I HAD HELP, SO
THAT'S THE FIRST THING.
BUT SO WE DID SOME DIGGING INTO
SOME OF OUR END OF YEAR '21
DOCUMENTATION.
WE KNOW, DR. BARKIN IT ASKED A
QUESTION IN THE CHAT YESTERDAY,
A WELL, SO WE'RE HOPING THIS
ADDRESSES BOTH OF THOSE THINGS.
THE CHALLENGE IS, WHAT IS YOUR
DEFINITION OF A NETWORK AND A
CENTER.
WE DID DO A FAIRLY BROAD
DEFINITION AND LOOKED AT BOTH
NETWORKS AND CENTERS THAT WE AT
NICHD SORT OF OWN, WE ARE THE
LEAD IC BUT ALSO CO-FUND WE
PROVIDE TO OTHER ICs FOR OTHER
NETWORKS AND CENTERS, SUCH AS IN
AIDS OR -- WELL MOST OF THE BIG
ONES ARE IN AIDS, TO BE HONEST.
SO WHEN WE DID THAT, WE CAME UP
WITH A GRANT TOTAL, SO THIS DOES
NOT INCLUDE CONTRACTS.
A GRANT TOTAL BEFORE $182
MILLION IN 2021.
THAT IS A LITTLE OVER 11% OF THE
TOTAL APPROPRIATION, WHAT WAS
SPENT IN 2021.
WE DO HAVE A FEW NETWORKS THAT
WE FUND USING CONTRACTS, NOT
GRANTS.
ONE OF THOSE, THE PRIDE I CAN'T
TELL PARTICULAR TRIAL NETWORK,
WE FUND COLLABORATION WITH ABOUT
20 OTHER ICs SO WE COLLECT
MONEY FROM THOSE ICs TO FUND
THE PEDIATRIC TRIAL NETWORK SO
NOT A LOT OF OUR DIRECT FUNDS GO
INTO THAT CONTRACT NETWORK.
BUT, AS I SAID IN GRANT DOLLARS,
IT IS ABOUT 182 MILLION FROM
LAST YEAR.
AS AN ESTIMATE.
ASSUMING YOU LIKE OUR
DEFINITION.
SO, I HOPE THAT HELPS, DR. TITA
AND DR. BARKIN, WE'RE HOPING
THAT MIGHT ADDRESS YOUR
QUESTION, AS WELL.
AND DR. JANE HAS HIS HAND UP.
>> DIANA, CAN I CAN I ASK A QUK
QUESTION.
I DIDN'T REALIZE ALEXIS WAS
GOING TO BE HERE THIS MORNING
I'M ALWAYS HERE.
>> A QUICK QUESTION FOR YOU,
YESTERDAY IN YOUR PRESENTATION
YOU SHOWED THE DISTRIBUTION OF
FUNDS, PARTICULARLY AS THEY
RELATE TO ADMINISTRATIVE BUDGETS
AND INTRAMURAL ALLOCATION, 5%
AND 14% FOR THE NICHD.
HOW DOES THAT COMPARE WITH OTHER
MAJOR INSTITUTES WITHIN NIH.
>> SO THAT'S A VERY GOOD
QUESTION.
SOIL SAY ACROSS NIH, BECAUSE OF
CONGRESSIONAL INTEREST, RIGHT
THERE SORT OF SOME ALMOST --
THEY'RE NOT UNSPOKEN, BECAUSE WE
KNOW WHAT THEY ARE, BUT MOST
ICs TRY KEEP THEIR RMS
SPENDING THAT ADMINISTRATIVE
AMOUNT, AROUND 5%.
YOU KNOW, DEPEND ON THE
SPECIFICS OF HOW AN IC FUNCTIONS
THAT AMOUNT CAN FLUCTUATE A
LITTLE BIT UP OR DOWN.
FOR INTRAMURAL PROGRAMS, THERE
IS A MUCH WIDER RANGE AND IT
ALSO -- IF YOU EVER LOOK AT THE
NATIONAL LIBRARY OF MEDICINE,
MUCH OF THEIR BUDGET, ALMOST 80%
IS CONSIDERED INTRAMURAL, EVEN
THOUGH IT IS NOT A LOT OF ACTUAL
LABS.
SO THEY HAVE THE VERY FAR END.
BUT SOME OTHER ICs HAVE VERY
SMALL INTRAMURAL PROGRAMS DOWN
TO 1% OR ZERO.
SOME ICs DO NOT HAVE
INTRAMURAL PROGRAMS.
FOR US AT 14%, WE ARE NOT -- WE
ARE NOT AT THE TOP BUT WE ARE,
YOU KNOW, IN THE UPPER THIRD, I
WOULD SAY, GENERALLY SPEAKING.
CONGRESS AS A WHOLE FOR NIH, SO
ON AVERAGE, LOOKS FOR INTRAMURAL
TO BE CLOSER TO 10% FOR ALL OF
NIH SO SOME OF THOSE ICs THAT
DON'T HAVE A PROBLEM HELP
BALANCE US OUT.
SO THOSE ARE SORT OF THE -- I
HOPE THAT ANSWERS YOUR QUESTION.
>> YES, THANK YOU.
WE KNEW SOME OF THIS INFORMATION
FROM THE INFORMATION DR. BIANCHI
PROVIDED AS YOU COUPLE YEARS
AGO.
JUST WANTED TO SEE IF THERE'S
ANY UPDATES.
THIS IS VERY HELPFUL.
THANK YOU, ALEXIS.
>> YOU'RE WELCOME.
>> I WANTED TO THE JUMP IN AND
THANK YOU FOR A VERY, YOU KNOW,
RAPID RESPONSE.
THAT REALLY LOOKS VERY
REASONABLE TO ME.
IT'S GREAT.
AND I AM, YOU KNOW, VERY HAPPY
WITH THE RESPONSE.
NOW, IF YOU MAY NOT HAVE THIS,
I'M JUST CURIOUS, YOU SAID THERE
WERE TWO TYPES, RIGHT?
THE ONES BY NICHD AND THE ONES
OUTSIDE.
DO YOU HAVE THE BREAK DOWN OF --
>> I DON'T HAVE THAT EXPLICITLY
BUT SOME EXAMPLES OF SOME OF THE
ONES THAT ARE OUTSIDE, FOR
EXAMPLE, THE NIAID IMPACT
NETWORK FOR AIDS, THE CENTERS
FOR AIDS RESEARCH, WHICH IS ALSO
RUN OUT OF NIAID.
THERE ARE ALSO SOME STUDIES RUN
OUT OF NIAID AND WE ALSO PROVIDE
SOME FUNDING TO THE RARE DISEASE
NETWORK, WHICH IS NOT OUT OF
NICHD AND WE COLLABORATE WITH
THREE ICs ON THE WELLSTONE
MUSCULAR DYSTROPHY PROGRAM, SO
ON SOME OF THOSE GRANTS WE ARE
THE LEAD AND ON OTHER GRANTS
DIFFERENT ICs, NIAMS IS ONE OF
THEM AND I'M UNFORTUNATELY
BLANKING ON THE THIRD, THEY ARE
THE LEAD SO THOSE ARE EXAMPLES
OF THE LARGER PROGRAMS WHERE WE
PROVIDE CO-FUNDING.
>> GREAT.
THANK YOU SO MUCH.
>> YOU'RE WELCOME.
>> THANK YOU, ALEXIS.
I JUST WANT TO CLARIFY, YOU SAID
THAT THIS WAS A LITTLE BIT OVER
11% OF THE TOTAL APPROPRIATION.
SO IF WE TOOK OUT DIR, THE
PERCENTAGE OF OUR DER BUDGET
WOULD BE EVEN HIGHER.
>> CORRECT.
>> CORRECT?
>> CORRECT.
IT WOULD BE A HIGHER PERCENTAGE
OF JUST THE EXTRAMURAL FUNDING
IF WE EXCLUDED THE FUNDING AND
INTRAMURAL, YES.
>> IT IS A SIGNIFICANT
PERCENTAGE.
>> I DID IT OUT OF THE TOTAL
BECAUSE THAT PIE CHART THAT WAS
IN THE SLIDE SHOW HAD THE TOTAL
APPROPRIATION AND WE WERE
TALKING ABOUT CENTERS AND
NETWORKS ON THAT PIE CHART ONLY
LOOK TO BE ABOUT 6%.
BUT AS I SAID THERE GRANTS IN
OTHER MECHANISM LINES WHICH
COULD BE INCLUDED SO OVERALL,
FOR THAT CHART, IT WOULD BE 11%.
>> GREAT.
AND THEN JUST FOR EVERYTHING'S S
AWARENESS, WE DO HAVE A
RELATIVELY BIG INTRAMURAL
PROGRAM AND THAT IS A POINT OF
DISCUSSION FOR OUR NEW
SCIENTIFIC DIRECTOR, WHOEVER HE
OR SHE MAY BE.
I THINK CHRIS McBAIN HAS
SHARED WE ARE THE 6th BIGGEST
IN TERMS OF TOTAL BUDGET.
SO 14% OF THE TOTAL IS THE 6th
LARGEST AMOUNT COMPARED TO OTHER
INSTITUTES AND CENTERS.
SO WE ARE SPENDING QUITE A BIT
ON OUR INTRAMURAL RESEARCH
PROGRAM.
AND IT IS ONLY ONE PIE, SO, YOU
KNOW, IF WE'RE SPENDING THERE WE
DON'T HAVE MONEY ELSE WHERE SO
THAT IS SOMETHING WE'RE ALWAYS
AWARE OF.
THANK YOU, ALEXIS.
YES, KATHERINE, DO YOU WANT TO
COME OFF MUTE AND MAKE YOUR
COMMENT.
>> I LOST TRACK OF WHAT MEETING
IS WHEN, BUT I KNOW WE HAD A
WONDERFUL PRESENTATION FROM THE
DIRECTOR OF INTRAMURAL RESEARCH
AT A RELATIVELY RENT MEETING AND
WE TALKED ABOUT PERCENTAGES AND
HOW NICHD WAS ON THE HIGHER END
BUT HOW A LOT OF THE WORK WAS
REALLY IMPORTANT AND COULD ONLY
BE DONE TRAIN MURALLY AND
WOULDN'T BE ABLE TO BE DONE
EXTRA MURALLY.
>> YES.
USUALLY IT IS THE SEPTEMBER
COUNSEL WE DEVOTE A LOT OF TIME
TO THE INTRAMURAL PROGRAM.
WE HAVE TWO THINGS TO GET TO
BEFORE WE HAVE THE CLOSED
SESSION.
ONE IS THE REPORT, WHICH IT JUST
FLOWS BEAUTIFULLY FROM THE
DISCUSSION REGARDING CENTERS AND
NETWORKS.
WE'RE GOING TO HAVE A REPORT BY
DR. BOB TAMBURRO WHO IS GOING TO
TAKE US THROUGH NICHD'S CLINICAL
TRIAL NETWORKS SO BOB, OVER TO
YOU.
THERE YOU ARE.
>> GOOD AFTERNOON ON THE EAST
COAST AND GOOD MORNING TO THOSE
IN THE REST OF THE COUNTRY.
MY NAME IS BOB TAMBURRO AND I'M
IN THE DIVISION OF EXTRA MURAL
RESEARCH AND I WILL BE
PRESENTING ON BEHALF OF THAT
DIVISION OUR PROPOSAL FOR
CONDUCTING MULTI-SITE CLUBCLE
TRIALS UTILIZING NICHD NETWORK
INFRASTRUCTURE.
IT DOESN'T SEEM LIKE MY SLIDES
ARE ADVANCING.
>> TRY CLICKING ON THE SLIDES
FIRST AND THEN USE THE SIDE
ARROWS.
>> OKAY.
HOW ABOUT THAT.
>> YUP.
>> ALL RIGHT.
SO I APOLOGIZE FOR THE TECHNICAL
DIFFICULTIES.
NICHD HAS HAD A LONG TRADITION
OF SUPPORTING MULTI-SITE
CLINICAL RESEARCH.
HERE ON THE LEFT OF THE SCREEN,
WE SEE A REPORT FROM NEARLY 50
YEARS AGO WHICH THE NICHD
SUPPORTED A NINE-CENTER STUDY
ASSESSING THE VALUE OF THE AM
AMNIOSENTISIS IN THE SECOND
TRIMESTER.
NOT LONG AFTER, CENTERS FOR
CLINICAL RESEARCH BEGAN.
IN 1985, THE NICHD FORMED THE
FIRST TWO NETWORKS.
THE NEO NATAL NETWORK AND THE
MATERNAL UNITS TO PERFORM LARGE
SCALE CLINICAL TRIALS AND
PROVIDE A FASTER, MORE EFFECTIVE
SYSTEM FOR EVALUATING NEO NATAL
CARE AND MATERNAL TREATMENTS.
IN THE ENSUING 35 YEARS, THESE
NETWORKS CONDUCTED SEMINOLE
RESEARCH THAT ADVANCED THESE
SKILLED AND IMPACTED CLINICAL
CARE AND PRACTICE.
SINCE THEN, THE NICHD CONTINUED
TO EXPAND ITS INFRASTRUCTURE
SUPPORT OF MULTI CENTER CLINICAL
TRIES, CREATING ADDITIONAL
NETWORKS THAT ADDRESS OTHER
ESSENTIAL AREAS OF HEALTH CARE
RELATIVE TO OUR MISSION THIS
INFRASTRUCTURE HAS SUPPORTED
HUNDREDS OF CLINICAL RESEARCH
PROJECTS AND TRIALS OVER THE
YEARS INFORMING CARE, RESULTING
IN CHANGES IN CLINICAL PRACTICE
AND ADVANCING OUTCOMES, FOR
INSTANCE, CHILDREN, ADOLESCENTS,
AS WELL AS PREGNANT AND LOOK
TATING INDIVIDUALS AND THOSE
WITH DISABILITIES.
BEGINNING IN 2016, THE NIH
PROPOSED AND SUBSEQUENTLY
IMPLEMENTED A SERIES OF REFORMS
TO ENHANCE CLINICAL TRIAL
STEWARDSHIP AND TRANSPARENCY AND
THERE BY FURTHER ASSURE THE
SUCCESS OF THE NIH CLINICAL
TRIAL ENTERPRISE.
AS PART OF THIS INITIATIVE AND
TO PROCEED VIEW CENTERS
FLEXIBILITIES ACROSS THEIR
DIFFERENT SCIENTIFIC AREAS,
INDIVIDUAL INSTITUTES AND
CENTERS WERE ASKED TO DEVELOP
THEIR OWN CLINICAL TRIAL FUNDING
OPPORTUNITY ANNOUNCEMENTS TO
JUST THEIR RESEARCH FUNDING
PRIORITIES AND STRATEGIC GOALS
IN RESPONSE, THE NICHD
REAFFIRMED ITS COMMITMENT TO
CONDUCTING RIGOROUS MULTI SITE
CLINICAL TRIALS AND IDENTIFIED
FOUR GUIDING PRINCIPLES OF THAT
RESEARCH.
IN THE FALL OF TO 19, THOSE
PRINCIPLES -- OF 201, THOSE
PRINCIPLES WERE EXPRESSED IN THE
GUIDE NOTICE, INFRASTRUCTURE FOR
NICHD MULTI SITE CLINICAL
TRIALS, AS WELL AS IN A WEBINAR,
STRATEGIC PLAN 2020
IMPLEMENTATION.
DAY'S VISION FOR MULTI SITE
CLINICAL TRIALS INFRASTRUCTURE.
THE FOUR GUIDING PRINCIPLES THAT
WERE EXPRESSED AND EMPHASIZED IN
THOSE FORUMS INCLUDED:
TO ENHANCE THE RIGGER AND
REPRODUCE ABILITY OF CLIN
CRIMINAL TRIAL PROTOCOLS.
TO PROMOTE GREATER AVAILABILITY
OF MULTI SITE CLINICAL TRIAL
INFRASTRUCTURE 0 TO SUPPORT
TRIALS FROM A WIDER RANGE OF
INVESTIGATORS TOMORROW
OFFICIALLY EXPAND RESEARCH
CAPACITY FOR ALL INVESTIGATORS.
TO FACILITATE GREATER
INVOLVEMENT OF DIVERSE
POPULATIONS AND MULTI-SITE
CLINICAL TRIALS.
WE BELIEVE THAT ADHERING TO THEE
PRINCIPLES ENSURE PROPER
STEWARDSHIP OF PUBLIC FUNDS,
INCREASES ACCOUNT.
AND HELPS NICHD MAINTAIN THE
PUBLIC'S TRUST.
ACCORDINGLY, IT IS NOT
SURPRISING THESE FOUR GUIDING
PRINCIPLES WERE BOTH IMPLICITLY
AND EXPLICITLY EXPRESSED IN
SEVERAL OF THE SCIENTIFIC
STEWARDSHIP GOALS DELINEATED IN
THE 2020 STRATEGIC PLAN.
HOWEVER, A PROCESS IS NEEDED TO
OPERATIONALIZE THESE GUIDING
PRINCIPLES.
TO BEST INFORM THIS PROCESS AN
EXTENSIVE ASSESSMENT WAS
CONDUCTED.
FIRST THE NICHD PUBLISHED A
QUESTION FOR INFORMATION,
FOLLOWING DR. BIANCHI'S WEBINAR
IN 2019 WITH THE GOAL OF US
HAVITYING INPUT FROM THE PUBLIC
ON ITS VISION FOR SUPPORTING
MULTI SITE CLINICAL TRIALS
INFRASTRUCTURE.
AS DR. CERNICH SHARED IN THE
2020 COUNSEL SULL, THERE WAS A
FARELY ROBUST RESPONSE TO THE
RFI BUT THE TOTAL OF 79
RESPONSES WE RECEIVED INCLUDING
19 COORDNATALIED MESSAGES FROM
PROFESSIONAL SOCIETIES AND
ASSOCIATIONS.
COMMON THEMES IDENTIFIED IN THE
RESPONSES INCLUDE BE SUPPORTING
MULTIPLE MODELS OF CLINICAL
TRIAL INFRASTRUCTURE, SPONSORING
MANY CLINICAL SITES TO ENSURE
DIVERSITY OF ENROLLMENT, HAVING
CORE SITES WITH WELL-TRAINED
STAFF.
INCREASING DIVERSE RESEARCHERS
THAT HAVE ACCESS TO THE
INFRASTRUCTURE.
PROVIDING AN ENVIRONMENT OF
RESEARCH, TRAINING OF YOUNG
INVESTIGATORS.
AND ENABLING FOLLOW UP BEYOND
THE TRADITIONAL FIVE-YEAR GRANT
PERIOD.
IN ADDITION, A PREFERENCE FOR A
CENTRALIZED APPROACH WHICH
NETWORK INFRASTRUCTURE IS
SUPPORTED OR AT LEAST A HYBRID
MODEL THAT INCLUDES ACCESS TO
THE CENTRALIZED MODEL WAS
EXPRESSED.
OTHER IDEAS SHARED IN THE RFI
RESPONSIBILITIES INCLUDED
CONDUCTING A LANDSCAPE ANALYSIS,
THE BEST CLINICAL TRIAL
PRACTICES ACROSS THE NIH AND
CREATING A DEDICATED NICHD STUDY
SECTION THAT ENHANCES EXTERNAL
PEER REVIEW AND FOSTERS
INCREASED OVERSIGHT AND
DECREASED CONFLICTS OF INTEREST.
CONSEQUENTLY AND SUBSEQUENTLY, A
LANDSCAPE ANALYSIS OF OTHER
PRACTICES ACROSS THE NIH WAS
PERFORMED.
BASED ON THIS FEEDBACK AND
INPUT, THE NICHD HAS OPTED FOR A
CENTRALIZED APPROACH IN WHICH
NETWORK INFRASTRUCTURE IS
SUPPORTED.
AS PART OF THIS CENTRALIZED
APPROACH, THE NICHD WILL
CONTINUE TO SUPPORT NETWORK
INFRASTRUCTURE, BUT WILL NOW
PERMIT ACCESS TO THE NETWORK
RESOURCES FROM ANY QUALIFIED
INVESTIGATOR AND ALL NETWORK
CLIN CRIMINAL TRIAL APPLICATIONS
WILL UNDER GO NIH PEER REVIEW.
WE BELIEVE THESE LAST TWO BULLET
POINTS REPRESENT TWO OF THE MOST
FUNDAMENTAL CHANGES OF THIS NEW
APPROACH.
THE CONGRESS SEPTEMBER BEING
PROPOSED THAT THE COUNCIL IS FOR
A DEDICATED FUNDING OPPORTUNITY
ANNOUNCEMENT TO SOLICIT CLINICAL
TRIAL APPLICATIONS TO LEVERAGE
THE A2 NETWORK INFRASTRUCTURE
AND TO OPERATIONALIZE THE
RECEIVED INPUT AND THE FOUR
GUIDING PRINCIPLES.
FIRST, TO ENHANCE
REPRODUCIBILITY, WE'RE
DEVELOPING A NEW PROTOCOL
PROPOSAL AND SELECTION PROCESS.
WITHIN THIS INITIATIVE, FUTURE
TRIAL WILL BE CONDUCTED WITHIN
THE NETWORK INFRASTRUCTURE WILL
BE SUB MISSED IN INDIVIDUAL AND
NIH APPLICATIONS WILL UNDER GO
NIH PEER REVIEW AND FUNDING
DECISIONS WILL BE MADE BY THE
NICHD LEADERSHIP WITH COUNCIL
PROVIDING THE NECESSARY AND
INFORMED SECOND LEVEL REVIEW AS
YOU DO FOR ALL APPLICATIONS,
PRIOR TO NICHD DECISION.
SECOND, 0 TO PROMOTE GREATER
AVAILABILITY OF MULTI SITE
CLINICAL INFRASTRUCTURE TO A
WIDER RANGE OF INVESTIGATORS.
THIS NEW INITIATIVE WILL ALLOW
ANY FROM THE EXTRA MURAL
COMMUNITY TO PROPOSE STUDIED
WITHIN THE NETWORK.
CERTAINLY THOSE IN THE FUNDED
NETWORK CLINICAL CENTERS WILL
WILL BE ABLE TO PROPOSE COUNTS
WITH THE FUNDING ANNOUNCEMENT
AND WE ANTICIPATE A LARGE NUMBER
OF PROPOSALS WILL STILL
ORIGINATE FROM THIS SOURCE.
INDEPENDENT OF THE SOURCE
INVESTIGATOR, STUDIES WILL NEED
TO ALIGN WITH THE PURPOSE, GOALS
AND OBJECTIVES OF THE NETWORK
AND WITH NICHD PRIORITIES.
NEXT, FACILITATING DATA SHARING
AND ACCESS TO BIO SPECIMENS LAB
TOP PRIORITY OF THIS INITIATIVE.
NETWORKS WILL BE REQUIRED TO
SHARE DATA AND BIO SPES MONIES
ACCORDING TO THE NIH POLICY FOR
DATA MANAGEMENT AND SHARING.
THE EFFECTIVE DATE FOR
IMPLEMENTATION OF THE DATA
MANAGEMENT AND SHARING POLICY IS
JANUARY 25, 2023.
IN ADDITION, CLIN CRIMINAL TRIAL
STUDY CONSENT FORM WILL BE
MODELED TO ALLOW BROAD SHARING
AND FUTURE USE OF STUDY DATA.
FURTHER, THE USE OF COMMON DATA
ELEMENTS, BOTH WITHIN INDIVIDUAL
NETWORKS AND ACROSS NICHD
NETWORKS WILL BE A PRIORITY.
FINALLY, AND IMPORTANTLY, IT IS
CRITICAL THAT WE CONTINUE TO
FACILITATE GREATER INVOLVEMENT,
A DIVERSE POPULATIONS IN OUR
MULTI SITE CLINICAL TRIALS,
INCLUDING THOSE INDIVIDUALS WITH
DISABILITIES.
AND I SAY CONTINUE BECAUSE I
BELIEVE THAT THIS HAS LONG BEEN
AN IMPORTANT CONSIDERATION FOR
OUR CLINICAL NETWORKS.
ENSURE DIVERSITY IN MULTI SITE
CLINICAL TRIALS INCLUDES BOTH,
THE STUDY PARTICIPANTS OBVIOUSLY
BUT ADDITIONALLY DIVERSITY AMONG
THE INVESTIGATORS.
NICHD TRIAL WILL BE EXPECTED TO
MAXIMIZE INCLUSION OF DIVERSE
STUDY PARTICIPANTS AND WE WILL
WORK TO CONTINUE TO DEVELOP
DIVERSITY IN THE WORKFORCE
ASCRIBED IN GUIDE NOTICE OD-2
OD-20-031.
IN ORDER TO OPT MUSE THE
SUCCESSFUL IMPLEMENTATION OF
THIS NEW APPROACH, WE BELIEVE
THAT THERE ARE FOUR MAIN
COMPONENTS TO BE ADDRESSED.
THEY INCLUDE:
IDENTIFYING WHICH SCIENCE WE
HOPE TO SUPPORT WITH THIS
MECHANISM AND ASSURING ITS
ALIGNMENT WITH THE APPROPRIATE
NETWORKS.
DEVELOPING AN IMPLEMENTING A
RIGOROUS PREAPPLICATION
SELECTION PROCESS.
ASSURING A JUDICIAL PEER REVIEW
PROCESS WITH THE NECESSARY
EXPERTISE AND YET FREE FROM ANY
CONFLICTS OR PERCEIVED CONFLICTS
OF INTEREST IN KEEPING WITH THE
LONG-STANDING EXCELLENCE OF NIH
PEER REVIEW.
AND, FINALLY, IDENTIFYING THE
MOST EFFECTIVE AND
COST-EFFICIENT METHOD OR METHODS
TO FUND THIS RESEARCH.
IN IDENTIFYING THE SCIENCE THAT
WE HOPE TO SUPPORT WITH THIS
INITIATIVE, THE PLAN IS TO START
SMALL AND EXPAND PROGRESSIVELY.
MOST MAJOR TRANSITIONS ARE
ASSOCIATED WITH MANY HURDLED AND
OBSTACLES, SOME ANTICIPATED AND
NOT SOME NOT AND THIS WOULD
APPEAR TO BE NO EXCEPTION.
CONSEQUENTLY, OUR PLAN IS TO
START SMALL, MONITOR AND RECESS
FREQUENTLY, LEARN FROM OUR
EXPERIENCES AND MODIFY AND
PROGRESS ACCORDINGLY.
WE PLAN TO BEGIN BY APPLYING
THIS APPROACH TO ONLY A HANDFUL
OF OUR NETWORKS, INCLUDING SOME
UNDER GOING RECOVERTITION.
IN DOING SO, WE HOPE TO IDENTIFY
SYNERGIES BETWEEN THESE NETWORKS
TO FURTHER OPTIMIZE OUR RESEARCH
AND LEVERAGE OUR RESOURCES.
I SUSPECT THAT MANY MEMBERS OF
COUNCIL AND OTHER -- AND OUR
PUBLIC AUDIENCE HAVE NOTED THE
RFAs FOR BOTH THE MFNU AND OUR
NETWORKS ARE CURRENTLY
PUBLISHED.
IN FACT, AS AN ASIDE, WE HAD TWO
PUBLIC WEBINARS DISCUSSING THESE
FUNDING OPPORTUNITIES JUST LAST
WEEK.
THOSE RFAs HAVE BEEN WRITTEN
TO FACILITATE IMPLEMENTATION OF
THIS NEW APPROACH BUT THE
PROVISION FOR NON-NETWORK
INVESTIGATOR PARTICIPATION AND
THE NEED FOR NETWORK PROPOSALS
TO UNDER GO NIH PYRE REVIEW.
WE WILL CONTINUE TO DEVELOP
RFAs IN A SIMILAR MANNER FOR
OTHER NETWORKS AS WE MOVE
FORWARD AND LEARN FROM OUR
EXPERIENCES.
ADDITIONALLY, THE CURRENT RFAs
EXPLICITLY CALL FOR THE
FORMATION OF AN EXTERNAL
SCIENTIFIC COMMITTEE AND
COMMUNITY ENGAGEMENT BOARD, IN
ADDITION TO THE COMMITTEE TO
FACILITATE WIDESPREAD UNFORMS
INPUT TO BEST ASSURE THE
DEVELOPMENT OF PRAGMATIC AND
FEASIBLE PROTOCOLS OF THE MOST
RELEVANT AND NEEDED SCIENCE.
FINALLY, AND AS IS RECOMMENDED
IN THE RESPONSE TO THE INITIAL
RFI, THESE CURRENT NETWORK
RFAs ARE FOR SEVEN-YEAR CYCLES
RATHER THAN THE TRADITIONAL
FIVE.
NEXT, WE BELIEVE THAT THERE
NEEDS TO BE A RIGOROUS
PRE-APPLICATION PROCESS THAT
WOULD NOT ONLY INCLUDE A
FEASIBILITY ASSESSMENT TO
DETERMINE IF THE PROJECT CAN
LIKELY BE SUCCESSFULLY COMPLETED
BY THE NETWORK, BUT WILL ALSO
REVIEW THE SCIENCE TO BE SURE
THAT IT IS RELEVANT TO THE
CURRENT STATE OF THE FIELD,
DEPRESSING SOCIETAL NEEDS TO THE
KNELT WORK MISSION AND TO NICHD
PRIORITIES.
A THIRD KEY TO SUCCESSFULLY
OPERATIONALIZING THIS NEW
INITIATIVE WILL BE THE REVIEW
PROCESS.
AGAIN HAVING CLINICAL NETWORK
TRIALS UNDER GOING NICHD PEER
REVIEW AS A SEPARATE APPLICATION
IS ONE OF THE FUNDAMENTAL
CHANGES TO THIS INITIATIVE AND
WILL GO A LONG WAY TO ENHANCE
THE RIGOR AND TRANSPARENCY
DESIRED.
ALTHOUGH IT NEEDS TO BE
FINALIZED IT WOULD I A PEER A
SPECIAL PROCESS THAT MAINTAINS
THE LONG-STANDING QUALITY OF NIH
REVIEW AND ASSURES THE EXPERTISE
TO REVIEW THE SCIENCE AND
UNDERSTAND THE BASIC FUNCTIONING
OF NIH-SUPPORTED NETWORKS WILL
BE CRITICAL AND INTEGRAL TO THE
PROCESS.
FINALLY, THE FUNDING THIS
INITIATIVE IS OBVIOUSLY A
FUNDAMENTAL COMPONENT.
TO BEGIN, THE GOAL IS TO REMAIN
GROSSLY COST NEUTRAL WITH OUR
CURRENT INVESTMENT IN MULE TIE
SITE CLINICAL TRIALS.
THAT SAID, THE HOPE BEING THAT
WITH MORE EFFECTIVE UTILIZATION
OF OUR CLINICAL NETWORK
INFRASTRUCTURE, WE WILL BE ABLE
TO OPTIMIZE OUR INVESTMENT SUCH
THAT WE SUPPORT THE BEST SCIENCE
AND THE MOST TIMELY AND COST
EFFECTIVE MANNER POSSIBLE.
IN ATTEMPTING TO IDENTIFY AND
DEVELOP THAT MODEL OR MODELS
WE'VE REACHED OUT TO OTHER NIH
AND FEDERAL PROGRAMS AS
SUGGESTED IN THE RFI RESPONSES.
THE ULTIMATE GOAL WILL BE TO
UTILIZE THE MODEL THAT OPTIMIZES
OUR FUNDED NETWORK
INFRASTRUCTURE.
IN CLOSING, THERE REMAINS MUCH
WORK TO BE DONE NOW AND LONG
INTO THE FUTURE.
WE ANTICIPATE THERE WILL BE MANY
CHALLENGES AND OBSTACLES ALONG
THE WAY.
THAT SAID, WE BELIEVE THAT THIS
NEW APPROACH HOLDS THE POTENTIAL
TO EXPAND THE BREADTH AND
DIVERSITY OF OUR SCIENCE AND
INVESTIGATORS, OPEN CHANCE THE
RIGOROUS TRANSPARENCY OF NETWORK
AND CLINICAL TRIALS, ENABLE US
TO PERFORM CLINICAL TRIALS IN
THE MOST EFFICIENT AND COST
EFFECT MANNER, ASSURE WE'RE IN
LINE WITH THE STRATEGIC PLAN,
IDENTIFY NOVEL AND INNOVATIVE
INVESTIGATIONS, FOSTER EMERGING
HEALTH CRISISES AS WE HAVE
RECENTLY LIVED AND ULTIMATELY
AUGMENT THE IMPACT OF THE
SCIENCE WE SUPPORT.
MUCH LIKE ANY GOOD RESEARCH
PROGRAM, THIS INITIATIVE REQUIRE
AS TEAM AND WE HAVE BEEN BLESSED
TO HAVE THE YOU UNYIELDING SUPT
AND INPUT OF OUR MANY DIVISIONS
OF EXTRA MURAL RESEARCH.
INCLUDING OUR BRANCH MANAGEMENT
AND SPECIALISTS, BUDGET OFFICES
AND FINANCIAL MANAGEMENT BRANCH.
CURRENT NETWORK PROGRAM
OFFICIALS.
OUR SCIENTIFIC PROGRAMMATIC
BRAND CHIEFS.
OUR CLCLINICAL TRIALS WORKING G.
I PARTICULARLY WANT TO RECOGNIZE
DR. JOT JANIS FROM THE PROGRAM.
IN THE END, IT HAS BEEN THE
MANTRA SHARED WITH US THROUGHOUT
BY DR. HASCROFT AND HIS
LEADERSHIP IN THIS ENDEAVOR.
IT IS NOT IMPORTANT THAT ANY OF
US VISUALLY BE RIGHT BUT THAT WE
COLLECTIVELY GET IT RIGHT.
AS SUCH, WE LOOK TO THIS COUNCIL
FOR FURTHER UNFORMED, DIVERSE
AND INSIGHTFUL INPUT AND WE HOPE
FOR A ROBUST DISCUSSION TODAY.
AND WITH THAT, I THANK YOU.
IS ANYONE STILL AWAKE?
>> WE ARE.
QUESTIONS?
BY THE WAY, I LOVE THE JIMMY
FALLON THANK YOU CARD THAT WAS A
CUTE TOUCH.
ALLEN.
>> YES, THANK YOU.
REALLY, THANK YOU SO MUCH,
DR. TAMBURRO, FOR THAT
PRESENTATION.
IT'S -- I'M KIND OF GETTING
DATED BECAUSE MY VERY FIRST
MEETING AS ON COUNCIL REALLY HAD
TO DO WITH NETWORKS AND IT'S
AMAZING HOW THINGS HAVE EVOLVED.
I WANT TO THANK YOU AND THANK
THE TEAM THAT, YOU KNOW, HAS
WORKED ON THIS OVER THE YEARS.
I KNOW LOTS OF EMOTIONS, SWEAT
AND YOU KNOW, ALL THE GROUND
WORK THAT YOU OUTLINED, YOU KNOW
HAVE GONE INTO THIS.
AND I REALLY LIKE AND FROM
TALKING TO, YOU KNOW, SOME OF
THE COMMUNITY MEMBERS, LIKE THE
PRODUCT, THE RFA THAT WAS PUT
OUT.
I THINK THERE ARE SOME REALLY
GREAT NUGGETS AND THE
PRINCIPLES, REALLY, YOU KNOW,
MAKE A LOT OF SENSE FOR
INNOVATION.
SO REALLY, CONGRATULATIONS TO
EVERYONE.
I WANTED TO JUST -- I THINK
DETAILS WILL BE FIGURED OUT WITH
THE KEY, I THINK THE KEY IS THE
PEER REVIEW THAT WILL BE DONE
THAT WILL GO TO, YOU KNOW, NIH
PANEL.
AND I THINK DETAILS WILL BE
SORTED OUT.
BUT I JUST WANTED TO RAISE SOME
CONCERNS THAT I'M SURE WE'LL BE
LOOKING TO.
IT IS THAT OF BEING NIMBLE AND
BEING EFFICIENT AND AVOIDING
SOME BOTTLE NECKS WITH HAVING,
SAY, A ONE-YEAR ROUNDS OF REVIEW
BEFORE SOMETHING IS FUNDED.
SO IS THERE A WAY THAT, IF THIS
WENT OUT FOR PEER REVIEW,
DECISIONS COULD BE MADE WITHIN
FOUR MONTHS, FOR EXAMPLE.
BECAUSE THE PREP PROCESS FOR
THIS, AS WELL AS YOU KNOW,
TAKES, YOU KNOW, NINE MONTHS IS
GREAT FOR ACTUALLY PREPPING THE
PROJECT WITHIN SOME OF THE
NETWORKS AND THEN IF YOU ADD THE
ADDITIONAL TIME, IT IS, YOU
KNOW, MAYBE, YOU KNOW, UP TO TWO
YEARS SO COULD THIS BE DONE IN A
VERY NIMBLE WAY PEER REVIEW AND
ITS --, FOR EXAMPLE.
>> IT IS A GREAT QUESTION AND
CERTAINLY ONE THAT, YOU KNOW,
WE'RE THINKING THROUGH.
AND WE'VE BEEN HAVING REGULAR
MEETINGS WITH OUR SCIENTIFIC
REVIEW TO GAIN SOME INSIGHT.
I THINK, YOU KNOW, IT'S A TOUGH
BALANCE BECAUSE YOU DO WANT TO
MAKE THINGS HAPPEN IN A TIMELY
MANNER BUT WE ALSO WANT TO
MAINTAIN THE REGULAR RUSS NIH
PEER REVIEW PROCESS.
WE'VE TALKED TO OTHER FEDERAL
PROGRAMS AND THEY'RE DOING
INTERESTING THINGS.
I THINK THE BEST I COULD SHARE
WITH YOU TODAY IS, WE
APPRECIATE, YOU KNOW, YOUR
CONCERN AND SHARE IT WITH YOU
AND ARE DOING EVERYTHING WE CAN
TO TRY TO EXPEDITE THAT PROCESS
TO KEEP THINGS MOVING IN AN
EFFICIENT MANNER.
WING LEARNED FROM COVID THAT
SOMETIMES YOU NEED TO MAKE
THINGS HAPPEN IN A MUCH MORE
RAPID TIME THAN THE TRADITIONAL
NIH PROCESS.
AND WE HAVE SEEN EXAMPLES OF
THAT HAPPENING IN A MORE TIMELY
MANNER COVID.
BUT I APPRECIATE THE QUESTION.
CERTAINLY ON OUR RADAR SCREEN,
CERTAINLY SOMETHING WE'RE
WORKING ON AND I HOPE WE WILL
COME UP WITH A GOOD ANSWER THAT
IS SATISFYING TO INVESTIGATORS
ACROSS THE EXTRA MURAL
COMMUNITY.
>> THANK YOU.
THAT WILL BE, YOU KNOW, IT WILL
BE TERRIFIC TO CONTINUE TO LOOK
INTO THAT.
I THINK IT'S REALLY, MAYBE IT IS
GOING TO BE REALLY CRUCIAL, THEN
JUST TWO, YOU KNOW, QUICK, ONE
IS A COMMENT, IS JUST THAT THE
INVESTIGATORS DON'T SEE
THEMSELVES AS JUST COMING TO DO
WORK FOR OTHERS AND A PART OF
THIS SCIENTIFIC THING, YOU
EMPHASIZED THAT SOME OF THIS
WILL COME FROM THE
INVESTIGATORS.
I THINK THAT WILL BE IMPORTANT.
THEN, FINALLY, BACK TO THE
BUDGET QUESTION EARLIER AND YOU
SAYING COST NEUTRAL.
THIS WILL BRING ADDITIONAL
GRANTS IN THAT WOULD HAVE GONE
OUTSIDE OF THE NETWORK.
SO I THINK COST NEUTRAL WILL
MEAN -- IT DOESN'T MEAN WHAT IS
CURRENTLY LOCATED LOCATED IN THK
WHAT COULD GO TO ADDITIONAL
PROJECTS.
>> THE DIFFERENCE BEING TO FUND
THE INDIVIDUAL PROTOCOLS WILL BE
THROUGH A SEPARATE OPPORTUNITY
ANNOUNCEMENT AND GOING TO PEER
REVIEW.
>> WILL THAT GROW WITH OUTSIDE
INVESTIGATORS?
>> ABSOLUTELY.
>> GREAT, THANK YOU.
>> NO, THANK YOU.
I WILL LOVE YOUR ENTHUSIASM, AND
WE'RE CERTAINLY ON THE SAME
PAGE.
MAKE THIS HAPPEN FASTER, SO
THANK YOU.
>> THANK YOU.
>> WE HAD ADAM RESNIK WAS NUMBER
TWO BUT HE DROPPED OFF.
THERE YOU ARE.
OKAY, ADAM.
>> I'M SORRY, I WAS LOWERING MY
HAND.
LET ME ALSO REITERATE MY -- CAN
YOU HEAR ME OKAY?
I WANT TO MAKE SURE.
>> WE CAN HEAR YOU PERFECTLY.
>> OKAY.
MY ENTHUSIASM IN THIS, SUCH AN
OPPORTUNITY NICHD IS TAKING TO
REALLY HARNESS AN APPROACH LIKE
THIS AND IT IS VERY TIMELY.
I WANTED TO ASK A COUPLE
QUESTIONS RELATED TO SORT OF
YOUR FOUR POINTS OF IMPACT AND
ESPECIALLY SOME OF THE THINGS
THAT WE'VE SEEN CAN BE
TRANSFORMATIVE BUT ALSO LIKELY
REQUIRE FROM CHANGE MANAGEMENT
IN THE CONTEXT OF NETWORKS.
THAT IS, ON THE DATA SIDE, AND
BY SPECIMENS AND WORK FLOWS,
THERE IS REALLY A -- YOU KNOW
MANY OF THESE NETWORKS AND
CLINICAL TRIAL FRAMEWORKS
EMERGED PRIOR TO THE ADVENT OF
TECHNOLOGIES THAT SUPPORT AND
OPTIMIZE DATA FLOWS AND STREAMS
AND OPTIMIZATION.
HOW ARE YOU THINKING ABOUT THE
INTERSECTION BETWEEN A
CENTRALIZED APPROACH AND, YOU
KNOW, THE OTHER EFFORTS WITHIN
NICHD RELATED TO DATA MANAGEMENT
FROM AN INFRASTRUCTURE
PERSPECTIVE, WHETHER THAT IS ON
THE DASH SIDE OR ANYWHERE ELSE.
HOW DO THOSE TWO PIECES COME
TOGETHER BETWEEN SUPPORTING A
CENTRALIZED FRAMEWORK FOR
CLINICAL TRIALS AND THE
RECOGNIZE QUREQUISITEINFRASTRUC.
>> YEAH, A GREAT QUESTION, AND
CERTAINLY THAT SHARING AS WE
MOVE FORWARD IS GOING TO BE A
HUGE PART OF OUR, YOU KNOW,
CLINICAL, NETWORK CLINICAL TRIAL
ENTERPRISE.
I'M GOING TO LOOK DR. REBECCA
ROSEN AND DR. VALERIE COTTON
FROM OUR OFFICE OF DATA SAFETY
AND SHARING FOR THAT GUIDANCE.
BUT YOU'RE ABSOLUTELY RIGHT.
MAKING SURE THAT OUR DATA
COORDINATING CENTERS ARE
COLLECTING, STORING AND
PROTECTING -- SHARING AND
PROTECTING THE DATA IN THE MOST
UP-TO-DATE MANNER IS GOING TO BE
INTEGRAL.
IN SOME WAYS HAVING THE
CENTRALIZED APPROACH WILL HELP
OPTIMIZE THAT RATHER THAN JUST
HAVING, YOU KNOW, INVESTIGATORS
AT LARGE COMING IN WITHOUT A
CENTRALIZED APPROACH.
BUT REALLY, I THINK A GREAT
QUESTION.
AND I WOULD ASK YOU, DR. RESNIK,
THOUGHTS YOU WOULD HAVE TO SHARE
SOME INSIGHT, MAYBE YOU COULD
PROVIDE TO HELP US AS WE WORK
THROUGH THAT.
IT REALLY IS AN IMPORTANT POINT.
>> ONE I WOULD ACTUALLY JUST
SAY, YOU'VE IDENTIFIED THE RIGHT
PEOPLE TO GUIDE YOU AND IT IS HE
WILL VERY TIMELY FOR NICHD TO LD
FROM THAT PERSPECTIVE AND IT
RELATES TO SOME OF THE
DISCUSSIONS YESTERDAY AROUND
MPERC AND OTHER PERSPECTIVES.
>> REBECCA ROSEN HAS PUT
SOMETHING IN THE CHAT BOX.
I DON'T KNOW IF YOU WANT TO COME
OFF FUTURE SO PEOPLE CAN AT
LEAST SEE YOU.
>> ABSOLUTELY.
THANK YOU, ADAM, FOR THE
QUESTION.
THIS FITS RIGHT INTO OUR
EXISTING DATA SHARING PRIME
WORK, MAYBE LESS SO WITH
MANAGEMENT, BUT THE EXPECTATION,
WRITTEN INTO THE DATA FUNDING
ANNOUNCEMENT, THE DATA
COORDINATING CENTER IS
RESPONSIBLE FOR CURATING AND
SUBMITTING THE DATA TO A A ANIH
DATA REPOSITORY.
THEY SHOULD BE ABLE TO TAKE IN
MOST OF THE DATA THAT ARE
MANAGED AND CURATED BY THE DATA
COORDINATING CENTERS FOR THE
VARIOUS CLINICAL TRIALS.
IF THOSE DATA ARE NOT
APPROPRIATE FOR DASH, FOR
EXAMPLE IMAGING DATA MAY NOT BE
BEST CURATED AND SEARCHED IN
DASH, WE WILL FIND BE ANOTHER
APPROPRIATE DESIGNATE REPOSITORY
FOR THOSE DATA BUT THE CURITIEDD
MANAGEMENT PIECE WILL STILL SIT
IN THE DATA CENTER.
TIMELINES ARE IMPORTANT, AS
WELL.
I WANT TO POINT OUT WITH THE NEW
DATA MANAGEMENT SHARING POLICY,
DATA WILL BE SHARED AT THE
LATEST AT THE TIME OF
PUBLICATION.
UNPUBLISHED DATA WILL BE SHARED
AT THE END OF AN AWARD PERIOD,
WHATEVER HAPPENS FIRST.
>> THANK YOU.
ANOTHER PART -- YEAH.
ANOTHER RELATED PART OF THAT ARE
THE BIO SPECIMENS, WHICH YOU
KNOW IN THE PREVIOUS ITERATION
OF THE NETWORKS, YOU KNOW,
INVESTIGATORS FELT THAT THEY HAD
OWNERSHIP OVER THOSE BIO
SPECIMENS.
I THINK THEY WERE TRYING TO
ALIGN OUR INSTITUTE WITH OVER
ALL NIH POLICY THAT BOTH
SPECIMENS AND DATA WILL BE
FREELY SHAREABLE.
SO, I DON'T KNOW, REBECCA, IF
YOU WANT TO COMMENT ON THAT.
>> I WILL ACKNOWLEDGE, I MEAN,
WE HAVE ROOM TO EXPAND ON DASH
TO ACCOMMODATE THIS AND WE ARE.
THIS IS A TOP PRIORITY, SO DASH
IS NOW IN MY OFFICE AND WE ARE
LOOKING TO -- WE ARE, WE HAVE
PLANS AND WE HAVE RESOURCES TO
EXPAND AND MOPPED EARNIZE DASH
TO ACCOMMODATE RAPID
DATA-SHARING CYCLES.
YOU DON'T NEED TO WAIT UNTIL THE
STUDY IS COMPLETE TO SHARE THE
DATA.
WE WANT TO SHARE ITERATIONS
ASSOCIATED WITH CURATED
CASSETTES.
HE WE WANT TO TAKE IN AND EXPOSE
DATA STANDARDS AND WE WILL DO IT
BASED ON THE NEEDS OF THE
RESEARCHERS, CLINICAL TRIALS AND
THE OFFICE OF NIH STRATEGY.
>> IT IS SUCH A TREMENDOUS
OPPORTUNITY TO REALLY LEAD A NEW
MODEL OF DOING THIS.
I'M NOT SURE I'VE SEEN LIKE TRUE
SUCCESS AT NIH AROUND THIS SO IT
IS A REAL OPPORTUNITY.
>> THANK YOU, ADAM.
LET'S GO TO GENEVIEVE NEIL-PERRY
NEXT.
>> THANK YOU FOR THAT
PRESENTATION, BOB.
THAT WAS GREAT.
VERY EXCITING.
I HAVE A QUESTION, HOW WILL
ADVERTISEMENT FOR THESE
OPPORTUNITIES OCCUR?
WILL THEY OCCUR THROUGH CENTERS?
HOW WILL IT ACHIEVE BROAD
REACHOUT?
>> GREAT QUESTION, AND THANK YOU
FOR THAT AND FOR THE KIND WORDS.
WHAT WE'RE HOPING IS WITH OUR
CONCEPT PROPOSAL TODAY IS TO
PREPARE A DEDICATED FUNDING
OPPORTUNITY ANNOUNCEMENT THAT
WE'LL DISTRIBUTE WIDELY THROUGH
THE GUIDE AS WE DO WITH ANY
OTHER FUNDING OPPORTUNITY
ANNOUNCEMENT, AND YOU KNOW,
START HITTING THE ROADS.
SHARING THESE IDEAS AS WE DO
WITH OUR DIFFERENT ORGANIZATIONS
AND SO FORTH.
BUT DISSEMINATING IT WADELY IS
CERTAINLY GOING TO BE A GOAL
WITH THIS AND STARTING WITH THE
FUNDING OPPORTUNITY ANNOUNCEMENT
SPECIFICALLY FOR THIS WILL BE
THE FIRST STEP.
>> AND MAY NEXT QUESTION IS, WIL
THERE BE ANY EMPHASIS ON EARLY
STAGE OR NEW INVESTIGATORS AND
THINKING ABOUT THIS AS A WAY TO
PRIME THE PIPELINE?
>> ABSOLUTELY.
AS YOU SAW IN SOME OF THE RFE
RESPONSES, TRAINING AND
MENTORING YOUNG INVESTIGATORS IS
GOING TO BE IMPORTANT.
YOU HEARD US MENTION, YOU KNOW,
FREQUENTLY THE DIVERSITY NOT
ONLY OF THE STUDY PARTICIPANTS
BUT OF THE INVESTIGATORS, AND I
WOULD CERTAINLY INCLUDE, YOU
KNOW, AGE AND PROFESSIONAL
EXPERIENCE IN THAT DIVERSITY.
AND THING MODEL REALLY HOLDS THE
POTENTIAL WHERE YOU CAN' LINE
SENIOR EXPERIENCED INVESTIGATORS
WITH YOUNG JUNIOR INVESTIGATORS
TO HELP THEM, YOU KNOW, GROW AND
DEVELOP.
SO ABSOLUTELY.
GREAT QUESTION AND WE ENSURE
YOUR ENTHUSIASM FOR
INCORPORATING YOUNG
INVESTIGATORS INTO THIS PROCESS.
>> THANK YOU.
>> GREAT.
I SEE DAVID ROWICH, MICHELLE,
LUCKY JANE, AND MELISSA MILLER.
WE WILL CUT IT OFF AFTER MELISSA
TO STAY ON TIME.
>> I'LL TRY TO BE BRIEF.
THANK YOU, DR. TAMBURRO.
I WELCOME THE NEW THINKING ABOUT
CLINICAL TRIALS DELIVERY.
KEY TO THE MISSION OF NICHD IS
HOW WE CAN SHOW ADVANCES IN
CARE.
AND YOUR GOALS THAT I THINK WERE
MAYBE ON THE THIRD TO LAST
SLIDE, POSSIBLY A COUPLE AHEAD
OF THE LATE NIGHT TV SHOW CARD
WAS THEY'RE LAUDABLE AND I
WONDER IF THEY COULD ALSO BE
CONSIDERED AT KEY PERFORMANCE
INDICATORS AND CAN YOU USE THOSE
GOALS TO DELIVER, TO DEVELOP
MEASURABLES, SUCH THAT, YOU
KNOW, THE IMPACT OF THIS PROGRAM
CAN REALLY BE DEMONSTRATED.
I THINK IT'S PROBABLY THE WAY
YOU'RE THINKING ABOUT IT.
I DIDN'T HEAR THAT ARTICULATED
SO THAT IS A SUGGESTION THAT IT
WOULD BE GREAT TO HEAR AS THE
PROGRAM MATURES HOW YOU'RE DOING
AGAINST GOALS.
SUCH AS NIMBLENESS, INNOVATION
AND A NUMBER OF THOSE OTHER
GOALS THAT I WOULD AGREE WITH
THAT YOU ARTICULATED.
THANK YOU.
>> NO, THANK YOU.
AND GREAT POINTS.
I WOULD AGREE, AND I DIDN'T GO
INTO A LOT OF DETAIL BUT ONE OF
THE THINGS THAT, YOU KNOW, WE'VE
TALKED ABOUT IS MONITORING AND
REASSESSING FREQUENTLY.
I REALLY LIKE THE WAY YOU SAID
THAT, IF YOU DON'T KEEP SCORE,
IF YOU DON'T HAVE A SCORE CARD,
YOU REALLY DON'T KNOW WHAT
YOU'RE DOING.
SO I THINK OBJECTTYIFYING THESE
RATHER THAN JUST HAVING
SUBJECTIVE PARAMETERS WILL BE
USED AS WE TRY TO EVOLVE AND
OVERCOME THE OBSTACLES AND
HURDLES WE KNOW WILL BE OUT
THERE.
GREAT POINT AND WE WILL TRY TO
OBJECTTYIFY THOSE ASSESSMENTS AS
MUCH AS POSSIBLE.
>> THANK YOU.
LET'S GO TO MICHELLE NEXT.
>> THANK YOU FOR THAT
PRESENTATION AND I THINK IT IS
GREAT TO LEVERAGE THE NETWORKS
TO MEET NICHD'S STRATEGIC GOALS
AND PLANS FOR INCLUSION.
I HAVE A QUESTION THAT SORT OF
FOLLOWING FROM DR. NEIL-PERRY.
SEA YOU HAVE AN OUTSIDE
INVESTIGATOR.
IS THERE ANY PLAN FROM NICHD TO
HELP CONNECT NEW MAY HAVE A
YOUNG OUTSIDE INVESTIGATOR, IS
THERE A PLAN TO CONNECT THEM
WITH THE NETWORK OR AND RESOURCE
FOR THAT?
IF NOT WILL NICHD ACTUALLY
PUBLISH SORT OF THESE
REQUIREMENTS FOR ENGAGEMENT
BETWEEN THE TWO?
BECAUSE I CAN ENVISION A NEW
INVESTIGATOR WHO WANTS TO DO
SOME SORT OF A CLINICAL TRIAL
AND HAVING DIFFICULTY MAYBE
CONNECT WAG NETWORK TO HAVE
THEIR -- SO THANKS.
>> THANK YOU.
A GREAT QUESTION.
OBVIOUSLY, TRYING TO CONNECT OUR
YOUNG INVESTIGATORS WITH OUR
ESTABLISHED INVESTIGATORS IS
GOING TO BE A KEY COMPONENT OF
THIS.
HOW BEST TO DO THAT, I THINK
WE'RE STILL TRYING TO SORT
THROUGH.
YOU KNOW, IT IS LIKE SO MANY
THINGS IN THIS WORLD, WE KNOW IT
IS A GOOD IDEA BUT MATERIALIZED
IT OR OPERATIONALIZING IT WILL
BE A CHALLENGE.
WE'VE GIVEN IT SOME THOUGHTS.
I WOULD SEE WHAT THOUGHT US
MIGHT BE WILLING TO SHARE ABOUT
THAT.
WE'RE CERTAINLY OPEN TO IT AND
REALLY WANT TO MAKE THIS, JUST
AS YOU DESCRIBE, SOMETHING OPEN
TO THE JUNIOR INVESTIGATORS.
SO ANY THOUGHTS THAT YOU WOULD
BE WILLING TO SHARE WITH THE
GROUP?
>> I WAS JUST THINKING IN ORDER
TO -- ALLOT OF TIMES YOU HAVE
THESE LARGER NETWORKS THAT ARE
SORT OF LARGER INSTITUTIONS, I
DON'T KNOW WHAT THE PLAN IS TO
ENGAGE WITH THE OUTSIDE
INVESTIGATORS, MAYBE A PORTAL
ARRANGEMENT WITH A GIVE AND TAKE
BETWEEN THE TWO SO IF YOU HAVE
BRAND NEW INVESTIGATOR WHO IS
NOVEL TO THE FIELD OR WHATEVER,
THEY MAY BE HESITANT TO APPROACH
ONE OF THESE LARGER NETWORKS SO
SOME WAY TO FACILITATE THOSE
CONNECTIONS, WHETHER IT IS IN
THE ANNOUNCEMENTS OR THROUGH
SOME SORT OF A PORTAL OR
PROFESSIONAL CONNECTIONS.
>> NO, IT MAKES A TON OF SENSE.
AND REALLY I THINK IT IS GOING
TO BE IMPORTANT.
I THINK ONCE THE JUNIOR
INVESTIGATORS GET CONNECTED WITH
THE NETWORK, YOU THINK IT WILL
BE A GOOD, POSITIVE
RELATIONSHIP.
I THINK YOUR POINT IS A GOOD
ONE, TO GET THAT INITIAL STEP,
YOU KNOW THAT INITIAL CONNECTION
IS GOING TO BE IMPORTANT.
SO I THINK IT IS SOMETHING, YOU
KNOW THAT WE, YOU KNOW, ARE
BEGINNING TO PROCESS.
I THINK REACHING OUT TO THE
NETWORKS AND HAVING THEM, YOU
KNOW, REACH OUT TO JUNIOR
INVESTIGATORS IN THEIR FIELD
WILL BE IMPORTANT.
I SAW IN THE CHAT, SOMEONE
MENTIONED PROFESSIONAL
ORGANIZATIONS, WHICH IS ANOTHER
GOOD WAY TO DO IT.
GREAT POINT AND WE WELCOME YOURS
AND OTHER'S THOUGHTS ON HOW BEST
TO DO THAT.
I DO THINK THAT IS A KEY
COMPONENT BE THE SUCCESS WE WANT
TO BE IN TERMS OF BRINGING
JUNIOR AND LESS-CONNECT THE
INVESTIGATORS INTO OUR NETWORK
INFRASTRUCTURE SO THANK YOU.
>> THANK YOU.
LET'S GO TO LUCKY JANE NEXT.
>> THANK YOU, DR. BIANCHI.
BOB, THANK YOU SO MUCH.
IF I UNDERSTAND THIS CORRECTLY,
THIS IS BRILLIANT.
IT SEEKS TO, YOU KNOW, CREATE
THE BEST OF BOTH WORLDS IN SOME
WAYS, LEVERAGING WHAT THE
NETWORK CENTERS CAN DO BUT ALSO
INVITING INNOVATIVE PROPOSALS
FROM ALL OVER TO BRING THE BEST
CLINICAL TRIALS TO THE BEDSIDE.
I HAVE TWO FUNDING QUESTIONS.
FIRST OF ALL, IN THE RFA THAT
WAS ANNOUNCED, DOES THAT RFA
PERTAIN TO THE NETWORK SITES
ONLY, OR IS IT ALL INCLUSIVE OF
CLINICAL TRIALS THAT WILL BE
SOUGHT OUTSIDE THE NETWORK.
THAT'S THE FIRST QUESTION.
THE SECOND QUESTION, BOB,
TYPICALLY NETWORK SITES IN ALL
NETWORKS WHETHER IT IS PCARN OR
ARDS NETWORK, NRN, MFU NETWORK,
THE HOST INSTITUTIONS END UP
PUTTING UP A FAIR AMOUNT OF
RESOURCES FROM WITHIN THE
INSTITUTION TO PEAT PARTICIPATN
WHAT IS CONSIDERED TO BE A
HIGHLY-PRESTIGIOUS AWARD,
PARTICIPATING IN THE NETWORK.
FOR US OVER HERE, THE
INSTITUTIONS I'VE BEEN INVOLVED
IN, BEING PART OF AN NIH NET
WORK A LINE OF SCRI IS A HUGE RT
TOOL FOR THE CLINICAL TRIAL
LIST.
ARE WE STILL GOING TO HAVE THAT
LEVERAGE IN GETTING THE CENTERS
TO PARTICIPATE IN DOUBLING THE
IMPACT OF THE MONEY, IF YOU
WILL.
>> YEAH, GREAT QUESTION AND
CERTAINLY ONE, YOU KNOW, THAT
YOU THINK WE NEED TO BE
COGNIZANT OF.
YOU'RE RIGHT, RIGHT NOW THERE IS
A TON OF PRESTIGE THAT GOES
ALONG WITH BEING AN NICHD OR ANY
NIH OR FEDERAL CLINICAL RESEARCH
NETWORK.
I THINK IT CAN BE EVEN THAT MUCH
MORE PRESTIGIOUS BECAUSE NOW
YOU'RE GOING TO BE PART OF THE
NETWORK THAT IS EMBRACING
DIVERSITY, THAT IS BRINGING IN
JUNIOR INVESTIGATORS, THAT IS
WILLING TO TAKE AN INNOVATIVE
IDEA FROM ANYWHERE ACROSS THE
COUNTRY AND YOU'RE STILL GOING
TO HAVE A SEAT AT THAT TABLE.
YOU WILL SEE THE APPLICATIONS,
THOSE PROTOCOL CONCEPTS AS THEY
COME IN AND HAVE THE PRIVILEGE
WORK THROUGH AND MAKE A GOOD
IDEA INTO A GREAT PROTOCOL.
SO I THINK IT IS A GREAT
QUESTION, IT IS A LEGITIMATE
CONCERN THAT CERTAINLY I KNOW
KEEPS ME AWAKE AT NIGHT, BUT I
REALLY THINK AT THE END OF THE
DAY IT IS GOING TO BE THAT MUCH
MORE PRPTHAT MORE PRESTIGIOUS.
I WANT TO MAKE SURE, THE NEW
FUNDING OPPORTUNITY ANNOUNCEMENT
WE WILL BE PROPOSING AS A
CONCEPT IN A FEW MINUTES THAT
WILL BE AVAILABLE TO ANYBODY IN
THE EXTRA MURAL COMMUNITY THAT
HAS A CLINICAL TRIAL THEY WANT
TO RUN THROUGH ONE OF OUR
NETWORKS AND THAT THEIR SCIENCE
THE ALIGNS WITH THE SCIENCE OF
THE NETWORK.
DID THAT ANSWER THE QUESTION?
>> WELL, YES, BOB.
I MEAN, MY SORT OF QUESTION IN
MY MIND, MAYBE I'M
MISUNDERSTANDING THIS, THAT
THERE ARE -- THERE'S STAY
NETWORK THAT YOU WILL ASSIGN
PRIMARY RESPONSIBILITY OF
RUNNING CLINICAL TRIALS, EVEN
THOUGH THE IDEA ORIGINATED FROM
ONE CENTER, WHICH WAS OUTSIDE OF
THE NETWORK, RIGHT?
>> YES.
>> SO THE QUESTION IS, THE RFA,
LET'S SAY FOR 2023, THE NRN HAS
$5 MILLION ALLOCATED OR X AMOUNT
ALLOCATED, IS THAT INCLUSIVE OF
ALL NETWORK -- THE PRIMARY
NETWORK THAT IS ESTABLISHED PLUS
THE CLINICAL TRIAL THAT WILL BE
RUN THROUGH THE NETWORK?
>> SO I THINK I'M UNDERSTANDING
THE QUESTION.
SO WE WILL CONTINUE TO SUPPLY
THE FUNDING FOR THE NETWORK
INFRASTRUCTURE, AND THEN THE
NETWORK CENTER PEAT WILLING HAVE
THE OPPORTUNITY TO SUBMIT TO
THIS FUNDING OPPORTUNITY
ANNOUNCEMENT PROCEED COMES
WITHIN THAT INFRASTRUCTURE AND
THEY WILL GET THE FUNDING FOR
THOSE PROTOCOLS FROM THIS NEW
FUNDING OPPORTUNITY ANNOUNCEMENT
THAT WE'RE PROPOSING.
>> YEAH, GREAT.
THANK YOU, BOB.
>> NO, THANK YOU.
>> THIS IS MORE OFF LINE
CONVERSATION, I JUST NEED TO
UNDERSTAND THE MECHANICS AT SOME
POINT, BUT THIS IS BRILLIANT.
I MEAN, I'M REALLY HAPPY THAT
DR. BIANCHI FOUND A WAY TO
CONTINUE TO PUSH THIS IMPORTANT
PART OF WHAT WE ARE HERE FOR TO
TAKE INNOVATIVE BASIC SCIENCE
IDEAS TO THE BEDSIDE.
BECAUSE UNTIL AND UNLESS SOME OF
THESE BRILLIANT FINDINGS IN THE
LABORATORY GET TO OUR PATIENTS,
WE'RE NOT REALLY ABLE TO -- I
MEAN, EVERYTHING ELSE IS A MEANS
TO AN END, AND THAT END IS TO
IMPROVE LIVESES RIGHT?
>> ABSOLUTELY.
>> SO I JUST WANT TO INDICATE
THIS IS AN INCREDIBLE TEAM
EFFORT AND THIS IS SOMETHING
THAT HAS BEEN DISCUSSED, AS YOU
KNOW, FOR SEVERAL YEARS AND
REALLY REPRESENTS A MAJOR EFFORT
TO BALANCE THE NEEDS OF
DIFFERENT STAKEHOLDERS AND YET
CONTINUE TO PUSH SOME OF THESE
CORE PRINCIPLES FORWARD AND
REALLY THE TEAM SHOWN IN BOB'S
SLIDE HAS WORKED INCREDIBLY WELL
TO ADDRESS ALL OF THESE ISSUES.
AND YOU KNOW, COME UP WITH A
SOLUTION.
SO, LET'S JUST ADDRESS MELISSA'S
QUESTION AND THEN, BOB, IF YOU
WOULDN'T MIND WHEN YOU'RE DONE
ANSWERING IN THE CHAT BOX THE
QUESTIONS, JUST SO WE DON'T GET
TOO FAR OFF SCHEDULE.
>> ABSOLUTELY, ABSOLUTELY.
>> LET'S GO TO MELISSA.
>> SURE.
I'LL BE VERY QUICK.
AS SOMEONE WHO HAS BEEN INVOLVED
IN A NUMBER OF MULTI-SITE
STUDIES, NOT WITH THE NIH BUT
THROUGH THE DOD PROCESSES, I
KNOW THAT IT'S VERY DIFFICULT,
ONE OF THE MOST DIFFICULT PARTS
OF GETTING THESE NETWORKS UP AND
RUNNING IS THAT FIRST STAGE OF
INTEGRATING THE NETWORKS
TOGETHER.
SO THE FACT THAT YOU PLAN TO
LEVERAGE ON GOING NETWORKS IS
FANTASTIC, BUT IT BRINGS IN A
WILD CARD, POTENTIALLY THAT NEW
PROJECTS WILL BE COMING IN FROM
INSTITUTIONS THAT ARE NOT
INVOLVED IN THE NETWORK.
SO, A COMPLICATING FACTOR.
I WANTED TO TOUCH -- OR ASK YOU
ABOUT THIS PRE-APPLICATION
PROCESS WHERE YOU WILL BE
EVALUATING THE FEASIBILITY OF
THESE PROJECTS.
AND ASK, WHO WILL BE PROVIDING
THE INPUT REGARDING THE
FEASIBILITY OF THE PROJECTS FOR
THE CENTERS.
>> I DON'T WANT TO GO INTO A LOT
OF DETAIL AS WE'RE FINALIZING
THAT, BUT YOUR POINT IS A GOOD
ONE.
WHAT I THINK IT'S GOT TO BE IS A
MULTI-GROUP PARTICIPATION.
I MENTIONED IN MY TALK, OUR
NETWORK STEERING COMMITTEES, AS
THEY'VE ALWAYS BEEN, PROTOCOL
REVIEW COMMITTEES ARE PART OF
THIS.
THEY KNOW WHAT THE NETWORK CAN
DO AND CAN'T DO.
THE DCC BEING PART OF THAT.
WE WANT THEM TO HAVE THEIR
EXTERNAL SCIENTIFIC GROUPS,
WHICH THEY'VE ALWAYS.
WHEN LOOKING AT IT SAYING YES,,
THIS IS IN ALINE WITH THE NEEDS
RIGHT NOW.
IN ADDITION WE WANT TO MAKE SURE
THEY ALL HAVE COMMUNITY
ENGAGEMENT BOARD.
WHAT DO WE MEAN BY THAT?
BRINGING THE PUBLIC IN.
WHAT DO YOU WANT TO SEE OUT OF
THESE NETWORKS?
WHAT IS IMPORTANT TO YOU AS
HEALTH RECIPIENTS AND UTILIZERS
OF THE SYSTEM.
AND THEN, FINALLY, YOU THINK WE
AT NICHD NEED TO HAVE SOME
INPUT, AS WELL.
RIGHT?
WE WANT TO MAKE SURE THESE
PROTOCOLS ARE ALIGNED WITH OUR
STRATEGIC MISSION SO WE'RE
OPTIMIZING THE RESOURCES THAT
CONGRATULATIONS GRACIOUSLY
PROVIDES US.
I THINK THAT'S THE QUESTION.
THAT'S WHERE THE RUBBER MEETS
THE ROAD WHEN YOU BRING IN THESE
GROUPS AND HAVE VERY CANDID
DISCUSSIONS.
THERE ARE TEAMS WE HAVE TO SAY,
GREAT IDEA BUT THIS NETWORK
CAN'T DO, THIS TOO LARGE, TOO
EXPENSIVE, WRONG POPULATION,
WHATEVER THE CASE MAY BE BUT
THAT IS REALLY THE CHALLENGE
THIS, WHEN WE START THE
INTERACTIONS HOW CAN WE MAKE
SURE SERVE WORKING TOGETHER SO
WE GET THE BEST PRODUCT IN THE
END.
GREAT INSIGHT, SO THANK YOU.
>> SO, THIS IS A GREAT
PRESENTATION.
GENERATED A LOT OF ENGAGEMENT.
I WANT TO THANK THE
COUNCILMEMBERS FOR THEIR
INSIGHTS AND WE WILL ADDRESS
SOME OF THE THINGS IN THE CHAT.
BOB IF YOU WOULD BE SO KIND TO
DO THAT ONCE WE RELIEVE YOU OF
THE SCREEN.
NOW I WILL HAND OVER THE VIRTUAL
MICROPHONE TO DR. TWOMBLY.
>> THANK YOU.
>> THANK YOU, BOB, BEAUTIFUL
JOB.
SO WE NOW COME TO THE CONCEPT
CLEARANCE PART OF THE OPEN
SESSION.
WE WILL BE PRESENTING 10
CONCEPTS FOR YOUR CONSIDERATION
TODAY.
FOR EACH CONCEPT, I WILL ASK THE
STAFF TO PROVIDE A BRIEF
OVERVIEW OF THE INITIATIVE AND
THEN ASK COUNCIL FOR ANY
DISCUSSION REGARDING THE
CONCEPT.
AT CONCLUSION OF THE DISCUSSION
FOR EACH CONCEPT, SKILL
COUNCILMEMBERS WHETHER OR NOT
THEY CONCUR.
OUR FIRST ONE WILL BE FROM
DR. TAMBURRO FROM THE DIVISION
OF EXTRA MURAL RESEARCH.
HE WILL PRESENT THE FIRST
CONCEPT ENTITLED MULTICENTER
CLINICAL TRIALS, LEVERAGING
NETWORK INFRASTRUCTURE TO
ADVANCE RESEARCH AND OUTCOMES.
BOB.
>> THANK YOU.
JUST WHEN YOU THOUGHT YOU HAD
GOTTEN RID OF ME, I'M GLAD FOR
THE OPPORTUNITY OUR PROPOSAL.
SO, BASICALLY, PROGRAM SEEKS
COUNCIL APPROVAL FOR A PROJECT
ENTITLED MULTI CENTER CLINICAL
TRIALS, LEVERAGING NETWORK
INFRASTRUCTURE TO ADVANCE
RESEARCH AND OUTCOMES.
THE NICHD HAS RECENTLY AFFIRMED
PUBLICLY AND BOTH THE GUIDE
NOTICE AND WEBINAR A PLAN FOR
ITS CONTINUED COMMITMENT FOR
INFRASTRUCTURE SUPPORT FOR MULTI
SITE CLINICAL TRIALS PURPORTING
FOUR PRINCIPLES.
ENHANCING CLINICAL TRIAL
PROTOCOLS, GREATER AVAILABILITY
OF MULTI SITE INFRASTRUCTURE TO
SUPPORT TRIALS FROM A WIDE
ARRANGEMENT OF INVESTIGATOR TO
FACILITATE DATA SHARING AND BILE
OH SPECIMENS AND OFFICIALLY
EXPAND RESEARCH CAPACITY FOR ALL
INVESTIGATORS AND FACILITATE
GREATER INVOLVEMENT OF DIVERSITY
FOR CLINICAL TRIALS THIS PROVIDE
AS FUNDING OPPORTUNITY
ANNOUNCEMENT THAT WILL ACCEPT
APPLICATIONS TO CONDUCT
MULTI-SITE CLINICAL TRIALS FROM
ANY INVESTIGATOR OF THE EXTRA
MURAL RESEARCH COMMUNITY.
THESE APPLICATIONS WILL UNDER GO
NIH PEAR REVIEW AND HAVING
MERITORIOUS TRIALS WILL BE
FUNDED IN INDIVIDUAL WARDS.
IN CONNECTION THIS FUNDING
OPPORTUNITY ANNOUNCEMENT WILL
MANDATE THE TIMELY SHARING OF
INFORMATION AND BIO SPECIMENS
VIA THE NICHD DATA AND SPECIMEN
HUB OR OTHER APPROPRIATE
PLATFORMS AND A RIGOROUS
PRE-APPLICATION REVIEW TO
PRO-ACTIVE ASSURE DIVERSITY OF
ENROLLMENT.
THANK YOU.
>> THANK YOU, BOB.
WE HAD A LOT OF GOOD QUESTIONS
IN THE MAIN PART OF THIS
PRESENTATION.
BUT IS THERE ANY MORE DISCUSSION
ON THIS?
>> YES.
>> GO AHEAD.
>> I WANTED TO MOVE TO APPROVE.
>> OH, I'M SORRY.
>> JUST A QUICK COMMENT.
THAT BILL FOR DISCUSSION WE'VE
HAD, THIS IS ALLINA, SUPPORT
TESTIFY OF THIS.
BUT GIVEN THE DISCUSSION WE HAVE
WOULD SUGGEST THAT THE
PRE-APPLICATION PROCESS FOR THIS
BE TIED INTO THE NETWORK
PROCESSES SO THAT THAT IS
SHORTENED AND THEY'RE NOT, YOU
KNOW, END TO TO -TO-END AND WOUD
SUGGEST LOOKING AT SHORTENING
THE REVIEW PROCESS.
I THINK IT IS IMPORTANT AT THE
BEGINNING OF THE NETWORK WHEN
THE SEATS ARE LOOKING FOR THINGS
TO DO AND THIS COULD TAKE ONE TO
TWO YEARS TO HAVE A REAL
DEVELOPED PROJECT.
SO JUST SOME SUGGESTIONS BUT
SUPPORTIVE.
>> THANK YOU.
OKAY.
ANY OTHER COMMENTS?
IF NOT --
>> THIS IS SHERRY BARKIN.
I HAVE A REALLY QUICK COMMENT.
I THINK EXCELLENT COMMENTS WERE
MADE IN THE CHAT BOX AND I KNOW
DR. TAMBURRO IS GOING TO TAKE A
LOOK AT THAT.
I THINK THOSE NEED TO BE
CONSIDERED.
I'M VERY SUPPORTIVE OF THIS
PROPOSAL, I JUST WANT TO MAKE
SURE WE CONSIDER THOSE THINGS,
AS WELL.
THANK YOU.
>> THANK YOU.
>> OKAY, IF NO FURTHER
DISCUSSION, MAY I HAVE A NOTION
APPROVE:
SO MOVED.
>> SECOND.
>> COULD YOU PLEASE USE YOUR
ZOOM SCREEN VOTING TO REAMING
OFFICER YOUR APPROVAL OR NOT
APPROVAL OR ABSTENTION.
>> I'M SHOWING 1 14 YES YESES.
>> VERY GOOD, THANK YOU.
NEXT WE HAVE DR.ING DOWN PRESENT
THE COORDINATING CENTER FOR THE
NICHD POPULATION DYNAMIC CENTERS
RESEARCH INFRASTRUCTURE PROGRAM.
ALL RIGHT.
GOOD MORNING.
OUR GOOD AFTERNOON, AS
APPROPRIATE TO YOUR LOCATION.
PROGRAM SEEKS COUNCIL APPROVAL
FOR THE TITLE COORDINATING
CENTER FOR THE NICHD RESEARCH
INFRASTRUCTURE PROGRAM.
THE POPULATION DYNAMICS RESEARCH
INFRASTRUCTURE PROGRAM PROVIDES
ESTABLISHED CENTERS WITH SUPPORT
FOR RESEARCH, DEMOGRAPHY,
POPULATION HEALTH AND BEHAVIORAL
AND SOCIAL HEALTH.
THE PRIMARY OBJECTIVES OF THE
COORDINATING CENTER ARE TO
IMPROVE THE TRANSLATION AND
DISSEMINATION FROM POPULATIONS
RESEARCH AND ENHANCE COOPERATION
AND COMMUNICATION CROSS PDRI
RECIPIENTS.
IT SIGNIFICANTLY AFFECTS HUMAN
HEALTH AND DEVELOPMENT.
POPULATION DYNAMICS RESEARCH IS
AT THE FOREFRONT OF HEALTH AND
PRODUCTIVITY ACROSS THE LIFE ARE
AFFECTED BY NON-MEDICAL FACTORS
SUCH AS THE SOCIAL DETERMINANTS
OF HEALTH AND THEIR INTERACTION
AT MULTIPLE LEVELS FROM GENES TO
ENVIRONMENT.
BY SUPPORTING A CENTRALIZED
RESEARCH FOR DISSEMINATION AND
COORDINATING ACTIVITIES THIS
INCREASES THE PRODUCTIVITY OF
CENTERS AND INDIVIDUAL
RESEARCHERS BY FREEING UP THEIR
TIME FOR RESEARCH, RESEARCH
TRAINING AND RESEARCH
DEVELOPMENT.
THIS IS INITIATIVE WILL ALSO
IMPROVE THE QUALITY AND IMPACT
OF DISSEMINATION ACTIVITY
BUSINESS PROVIDING TRANSLATIONAL
EXPERTISE AND GUIDANCE THAT IS
UNLIKELY TO BE AVAILABLE TO
CENTERS AND INDIVIDUAL
RESEARCHERS.
THIS PROPOSED INITIATIVE IS
CRITICAL TO ADVANCING THE
SCIENTIFIC PRIORITIES TO THE
POPULATIONS DYNAMICS BRANCH AND
THUS IT ALIGNS WITH NICHD'S
STRATEGIC PLAN 3 AND 4,
CROSS-CUTTING HEALTH
DISPARITIES, DISEASE PREVENTION
AND GLOBAL HEALTH.
THE ASPIRATIONAL GOAL OF
TRAINING THE NEXT GENERATION OF
SCIENTISTS AND PROMOTING AN
INCLUE SINCLUSIVE SCIENTIFIC WO.
THANK YOU.
>> ALL RIGHT DO WE HAVE ANY
QUESTIONS OR COMMENTS ABOUT THIS
CONCEPT?
>> QUESTION.
THIS IS REBECCA WONG.
THANK YOU, ROSS.
I THINK THIS IS A GREAT IDEA.
I DON'T KNOW IF WE HAD ONE
BEFORE, I WAS WONDERING ABOUT
THAT.
IF THERE HAS BEEN A CENTER?
>> YES, WE'VE HAD ONE.
WE FIRST ISSUED THE RFA FORTH
COORDINATING CENTER IN 2017 AND
THE CONCEPT NEEDS TO BE
RECLEARED EVERY FIVE YEARS.
>> NOW A FOLLOW UP.
I'M SORRY.
DO YOU IMAGINE THIS NECESSARILY
THAT IT HAS TO BE AN ACADEMIC
INSTITUTION RESPONDING TO THIS?
>> NO, ABSOLUTELY NOT.
ANY INSTITUTION THAT HAS THE
REQUISITE CAPITAL, INSTITUTIONAL
CAPACITY AND ENVIRONMENT AND
WOULD HAVE THE APPROPRIATE
INVESTIGATORS.
>> THIS IS SHERRY BARKIN.
HE JUST HAVE A FOLLOW UP
QUESTION FOR THAT.
THANK YOU FOR THAT PRESENTATION.
CAN YOU TELL ME FROM THE LAST
ONE, IS THERE ANYTHING WE'VE
LEARNED FROM THAT MOVING
FORWARD?
>> THE BIGGEST THING IS WE'RE
THINKING ABOUT WHAT MEDIA THEY
USED WHETHER WE FIRST COMPETED
THIS, SOCIAL MEDIA HAS REALLY
ADVANCED.
A LOT OF OTHER METHODS OF
COMMUNICATION HAVE REALLY,
THINGS WE DIDN'T RELY ON AS MUCH
SO WE'RE REALLY HOPING TO SEE,
THAT THAT IS PART OF EFFECTIVE
DISSEMINATION AND TRANSLATION IS
LEARNING HOW TO USE ALL THESE
DIFFERENT CHANNELS AND WE'RE
REALLY HOPING TO SEE THAT'S
INVOLVE OVER THE NEXT
COMPETITIVE CYCLE.
>> THAT'S INTERESTING.
I'M SORRY, THIS IS REBECCA
AGAIN.
THAT'S EXACTLY WHAT I WAS
THINKING THAT GETTING TO THE NEW
TECHNOLOGY, THAT PROBABLY WE
NEED TO GET OUT OF ACADEMIC
WORLD AND THERE MIGHT BE OTHER
PEOPLE OUT THERE THAT CAN DO IT
PER, BUT I DON'T KNOW, I DON'T
HAVE ANYBODY IN MIND BUT I WAS
JUST THINKING OF SOMEBODY WHO
CAN THINK OUTSIDE OF THE BOX.
>> OKAY.
ANY OTHER QUESTIONS?
IF NOT, MAY I HAVE A MOTION FOR
APPROVAL?
>> MOVE TO APPROVE, PLEASE.
>> THANK YOU.
SECOND?
>> SECOND.
>> VERY GOOD.
PLEASE VOTE NOW USING YOUR
BUTTONS AT THE BOTTOM OF THE
ZOOM SCREEN.
>> 15 VOTES.
>> 16.
>> 16?
OKAY.
GREAT.
THANK YOU.
NEXT UP WE HAVE DR. DAVID
WINEBURG FROM THE PREGNANCY AND
PERI NAY NATOLOGY BRANCH ON
BRAIN DEVELOPMENT AND NEURO
OUTCOME.
>> SEEKS COUNCIL APPROVAL FOR A
INITIATIVE TITLES OPIOID
EXPOSURE AND EFFECTS ON PLACENTA
FUNCTION, BRAIN DEVELOPMENT AND
NEURAL OUTCOMES.
BRAIN DEVELOPMENT IN THE FETAL
ANNAND, AND NEONATAL BE INFLUEN,
IS AFFECTED BY MATERNAL
SUBSTANCE USE.
FURTHERMORE, DESPITE
LONG-STANDING NORMAL THAT THE
PLACENTA IS CRITICAL IN
DEVELOPMENT, THERE IS LITTLE TO
KNOW HOW IT CAN INFLUENCE AND
ALTER FETAL BRAIN DEVELOPMENT.
THE MECHANISTIC AND
UNDERSTANDING OF HOW FETAL
EXTERNAL SYSTEM AND BRAIN?
INTERACT IN RESPONSE TO OPIOID
AND POLY SUBSTANCE USE TO UP
PACT THE NEONATAL INFANT
DEVELOPMENT OUTCOMES IS UNKNOWN,
HOWEVER THIS KNOWLEDGE IS
CRITICAL TO ESTABLISHING
APPROPRIATE EARLY INTERVENTION
AND FOR ESTABLISHING CLINICAL
GUIDELINES FOR PAIN MANAGEMENT
IN PREGNANT PEOPLE.
THIS INITIATIVE WILL LEVERAGE
INNOVATIONS AND IMAGING
TECHNOLOGIES THAT HAVE ALLOWED
FOR SIGNIFICANT ADVANCES IN
DELINEATING STRUCTURAL AND
FUNCTIONAL TR TRAJECTORIES OF FL
DEVELOP.
AND THE FIRST SEVERAL MONTHS OF
INFANCY.
AND EVALUATION OF BLOOD BIO
MARKERS ARE POINTS FOR
APPLICATION TO ACCESSING THE
IMPACT OF OPIOID EXPOSURE THIS
INITIATIVE ALIGNS WITH THE
PRIORITIES OF THE PREGNANCY AND
PERINATOLAGY BRANCH OF NICHD AND
ADDRESSES THE STRATEGIC PLAN
GOALS FOR SETTING THE FOUNDATION
FOR HEALTHY PREGNANCY AND
LIFE-LONG WELLNESS AND IMPROVING
CHILD IN ADOLESCENT HEALTH AND
TRANSITION TO ADULT HOOD.
IMPORTANTLY, IT ALIGNS WITH THE
TRANS -- NITL AND OTHER CENTERS
AND OFFICES.
THANK YOU.
>> THANK YOU, DR. WINEBURG ARE
THERE QUESTIONS OR COMMENTS
ABOUT THIS CONCEPT?
>> HI, THIS IS THEY ARE YES
BARKIN THANK YOU.
CONNECT AT ALL WHAT WE WERE
LEARNING ABOUT THE BRAIN
INITIATIVE?
>> I THINK IT SINN SING SING IIS
AND I DON'T KNOW IF DR. BIANCHI
WHO SERVES UP THE CHAIN WOULD
LIKE TO COMMENT.
>> YES.
SO, I JUST ACTUALLY HAD A
DISCUSSION WITH REBECCA BAKER
THIS MORNING, WHO IS THE PROJECT
LEAD FOR HEAL.
WHAT WE REALLY FELT, WE'RE
ALWAYS TRYING TO USE SOME OF THE
HEAL FUNDING TO ADDRESS NEEDS IN
OUR POPULATIONS EITHER WITH
REGARD TO OPIOID MISUSE OR PAIN
IN POST CAESAREAN SECTION WOMEN.
IT IS NOT DIRECTLY LINKED BUT IT
IS INDIRECTLY LINKED SO THERE IS
SOME CROSSOVER WARDING THE HBDC
STUDY, THE HEALTHY BRAIN AND
COGNITIVE DEVELOPMENT.
EXCUSE ME.
BUT REALLY THE FOCUS OF THIS
PARTICULAR PROJECT WILL BE ON
HOW OPIOIDS AFFECT THE PLACENTA
AND IF THERE ARE ABNORMALITIES
IN PLACENTA DEVELOPMENT THAT
SUBSEQUENTLY AFFECT NEURAL
DEVELOPMENT.
THERE ARE A LOT OF PEOPLE
INVOLVED FROM THE NIH
PERSPECTIVE SO THERE WILL BE
INDIRECT CONNECTIONS AND LINKS
IS THAT FAIR TO SAY, DAVID?
>> ABSOLUTELY.
I THINK I'M ALWAYS TRYING TO
LOOK AT HOW THE WHOLE GETS
TOGETHER BECAUSE THERE ARE SO
AMERICAN INTERESTING INITIATIVES
MOVING FORWARD.
WHATS WAYS TO CROSS LINK AND
ASYNERGIES TO MAXIMIZE INPUT.
THANK YOU.
>> IT IS A GREAT POINT.
>> I'M VERY SUPPORTIVE OF THIS.
ESPECIALLY CONSIDERING THE
CRISIS WITH FENTANYL, CONCERNING
TRENDS AND THIS IS, I THINK, A
CRITICAL ISSUE TO ADDRESS.
IF THERE ARE NO OTHER COMMENTS,
I'M ALSO HAPPY TO MAKE A MOTION
TO APPROVE.
>> OKAY.
I THOUGHT I SAW DR. LANG BRIEFLY
UP THERE SAY IN DID BUT I WAS
GOING TO ASK HOW IT WENT WITH
THE HBCB STUDY BY DIANA ANSWERED
THAT.
>> OKAY, GOOD SO WE HAVE A
NOTION APPROVE DO WE HAVE A
SECOND?
>> SECOND.
>> THANK YOU.
COULD YOU PLEASE GO DOWN TO THE
ZOOM VOTING PANEL AND REGISTER
YOUR VOTES.
>> I'M COUNTING 15 VOTES.
16.
CAN.
>> OKAY THANK YOU.
NEXT DR. WINEBURG WILL ALSO
PRESENT.
DAVID.
>> PROGRAM SEEKS COUNCIL
APPROVAL FOR AN INITIATIVE
TITLED ADVANCING METHODS FOR
SAFE, NON-INVASIVE REAL TIME
ASSESSMENT OF PLACENTA
DEVELOPMENT AND FUNCTION ACROSS
PREGNANCY.
DESPITE INTENSIVE RESEARCH OF
EARLY RISK ASSESSMENT IN
PREGNANCY, THERE IS STAY
CRITICAL LACK OF EFFECTIVE TOOLS
AND METHODS OF SAFE REL TIME
ASSESSMENT OF PLACENTA
DEVELOPMENT ACROSS THE PREGNANCY
TIME COURSE.
THE NICHD LAUNCHED THE HUMAN
PLACENTA PRACTICE JECT, HPP IN
2014 TO ADDRESS THIS CRITICAL
GAP.
THEY'VE VESTED OVER $87 MILLION.
THERE IS A CROSS OF IMAGING AND
OMIX APPROACHES.
HOWEVER, MAKING THE JUMP TO
CLINICAL IMPLEMENTATION REQUIRES
ADDITIONAL STUDIES TO PROVIDE
CONFIRMATION AND VALIDATION.
IN CONNECTION, BY NECESSITY, THE
HPP AWARDS RENTED INDIVIDUAL
EFFORTS AND MOST LIKE AN INT
FREIGINTEGRATED APPROACH WILL HE
THE GREATEST POTENTIAL.
THIS IS AIMED AT VALIDATION AND
MULTI MODAL APPROACHES AND IS A
REQUISITE NEXT STEP OF THE
PROGRESSION OF THESE APPROACHES
TOWARDS CLINICAL ACCEPTANCE.
THE HPP HAVE STILL LATE RED
SEARCH GLOBALLY AND ADVANCES IN
CENTERS AROUND THE WORLD THIS
INITIATIVE WOULD BE OPEN TO ALL
INVESTIGATORS FOREIGN OR
DOMESTIC.
THIS INITIATIVE IS IN DIRECT
ALIGNMENT WITH NICHD'S THEME
THREE, SETTING THE FOUNDATION
FOR HEALTHY FLAG NANCYS AND
CROSS-CUTTING THEMES RELATED TO
PREPREG NANCY HEALTH, PREVENTION
OF ADVERSE OUTCOMES, EARLY
DETECTION AND EFFECT OF PA
PATHOGENS ON PREGNANT WOMEN THID
BE RELEVANT TO THE IMPACT OF
INFECTIOUS DISEASE AND
TREATMENT.
THANK YOU.
>> THANK YOU, AGAIN,
DR. WINEBURG.
ARE THERE QUESTIONS OR COMMENTS
ABOUT THIS CONCEPT?
OKAY.
IF NOT, MAY I HAVE A MOTION FOR
APPROVAL?
>> MOTION TO APPROVE.
>> SECOND?
>> SECOND.
>> THANK YOU.
OKAY, PLEASE VOTE NOW ON THE
ZOOM SCREEN.
>> WE HAVE 16 VOTES.
>> THANK YOU.
NEXT WE HAVE THE PREGNANCY AND
PERINATOLOGY BRANCH.
>> THANK YOU VERY MUCH.
PROGRAM SEEKS COUNCIL APPROVAL
FOR TITLE MATERNAL HEALTH
RESEARCH CENTERS FOR EXCELLENCE.
WE KNOW THE MORTALITY RATES ARE
THE HIGHEST OF ANY DEVELOPED
COUNTRIES.
THE CDC REPORTS THAT IN 2020,
861 WOMEN WERE IDENTIFIED AS
HAVING WIDE OF MATERNAL CAUSE IN
THE UNITED STATES AND IN
CONNECTION 50,000 WOMEN
EXPERIENCE MORBIDITY AND
MORTALITY EVERY YEAR TOMORROW
ADDRESS THIS PUBLIC HEALTH
CRISIS, THE NATIONAL INSTITUTE
OF HEALTH LAUNCHED THE
IMPLEMENTING AND MATERNAL HEALTH
AND PREGNANCY OUTCOME INITIATIVE
THAT DR. BIANCHI MENTIONED
YESTERDAY.
THE INITIATIVE SUPPORTS RESEARCH
AND HOW TO PREVENT MATERNAL
MORTALITY, DECREASE SEVERE
MORBIDITY AND PROMODE HEALTH
EQUITY.
IN 2022, THE PRESIDENT'S BUDGET
INCLUDED A 30 MILLION FOR NICHD
TO EXPAND THE IMPROVE INITIATIVE
AND LAUNCH THE CENTERS OF LESS
THAN SUPPORT RESEARCH FROM JECTS
THAT WILL INCORPORATE LOCAL
COMMUNITY NEEDS AND
PERSPECTIVES.
THE PURPOSE OF THIS INITIATIVE
IS TO ESTABLISH THESE MATERNAL
HEALTH CENTERS OF EXCELLENCE IN
GEOGRAPHICALLY DIVERSE REGIONS
AND IN PARTNERSHIP WITH THE
COMMUNITIES MOST AFFECTED THIS
INITIATIVE WILL USE AN
INTEGRATED APPROACH WITH SOCIAL,
BIO RESEARCH AND STRATEGIES TO
ADDRESS THE MULTIPLE
CONTRIBUTING FACTORS, INCLUDING
SOCIAL DETERMINANTS IN HEALTH
AND SYSTEMIC FACTORS SUCH AS
STRUCTURAL RACISM THAT LEAD TO
HEALTH DISPARITIES.
THE GOAL OF THIS INITIATIVE IS
FOR A TRANSDISCIPLINARY
RESEARCHER CONDUCT MULTI LAYERED
NOVEL APPROACHES THAT HAVE THE
ABILITY TO ADDRESS SEVERE
MATERNAL MORBIDITY AND FATALITY
AND DEATHS.
THIS CONCEPT ALIGNS WITH THE
PROPOSED INITIATIVE, THE
STRATEGIC PLAN, SPECIFICALLY
THEME THREE, SETTING THE
FOUNDATION FOR HEALTHY FLAG
NANCYS AND LIFE-LONG WELLNESS AS
WELL AS THE CROSS-CUTTING THEME
OF HEALTH DISPARITIES THIS ALSO
ALIGNS WITH THE PRIORITIES OF
MULTIPLE BRANCHES AT NICHD
INCLUDING THE PREGNANT YES, I
DID. AND PERIONATOLOGY BRANCH.
THANK YOU.
>> ARE THERE QUESTIONS OR
COMMENTS ABOUT THIS CONCEPT.
>> COMMENT.
TO SUPPORT THIS AND SAY IT IS A
FANTASTIC OPPORTUNITY.
HOW WILL THIS, ANY PLANS ABOUT
HOW THIS WILL WORK VIS A VIS SAY
THE MATERNAL FETAL MEDICINE
UNITS NETWORK THAT ALSO MAY BE
ADDRESSING SOME OF THESE ISSUES.
>> ABSOLUTELY.
WE'RE HOPING THIS WORK WITH BE
SYNERGISTIC WITH THE UNITS,
WHETHER AS WE DEVELOP THIS
FURTHER, WE CAN SEE A
COLLABORATIONS BETWEEN THE TWO,
BETWEEN THE RESEARCH CENTERS AND
THE MATERNAL FETAL MEDICINE UNIT
AS WE MOVE FORWARD S DEFINITELY
THINK THERE WILL BE SYNERGISTIC.
>> ONE POPULATION WE HAVEN'T YET
FOCUSED ON ARE AMERICAN INDIANS
AND ALASKA NATIVES AND WE ARE
SCHEDULED TO HAVE A TRIBAL
CONSULTATION THIS MONTH IN
ADVANCE SO THIS IS AN AREA FOR
THOSE THAT DON'T KNOW, AMERICAN
INDIANS AND ACLASS NATIVES HAVE
ALMOST AS HIGH IN TERMS OF BLACK
WOMEN IN SEVERE MORBIDITY AND
MORTALITY .
IT IS IMPORTANT TO REACH OUT
THOUGH THESE POPULATIONS AND
THEY'RE NOT NECESSARILY INCLUDE
AND A BIG PART OF THE FOCUS OF
THE CENTERS FOR EXCELLENCE IS TO
HAVE COMMUNITY ENGAGEMENT AND
INVOLVEMENT BUT WE RECOGNIZE THE
MFMUs ARE DOING THAT SO HE
WILL: COORDINATING AND
INTEGRATING RESOURCES WHEREVER
WE CAN.
>> THANK YOU.
IT IS A REALLY GREAT
OPPORTUNITY.
SOME OF THESE STUDIES THAT MAY
BE DONE IN ONE SETTING IS LIKE,
WILL THIS REALLY WORK IN THE
COMMUNITY WITH IMPLEMENTATION,
SO I REALLY AGREE WITH THIS AND
THE SYNERGY BETWEEN THOSE AND
SUPPORT THIS.
THANK YOU.
>> THANK YOU.
>> DR. BARKIN.
>> I'M EXCITED ABOUT THIS.
PRO QUESTIONS.
THE FIRST IS, WHEN DOES A MOTHER
BEGIN?
>> SO FOR THIS SPECIFIC
INITIATIVE, WE'RE FOCUSING ON
THE PREGNANCY AND THE PREGNANCY
OUTCOMES WITHIN THE ONE YEAR
POST-PARTUM PERIOD.
WE ARE OTHER INITIATIVES THAT
WILL BE ADDRESSING THE LIFE-LONG
PERSPECTIVE BUT FOR THIS WE'RE
FOCUSING ON THE TIME PERIOD WITH
THE HIGHEST RISK OF MORBIDITY
AND MORTALITY.
>> THANK YOU.
THE SECOND HAS TO DO WITH, I SEE
THAT YOUR CONCEPTUALIZING IT IN
A REALLY INTEGRATED WAY, IT IS
BIO BEHAVIORAL, BIO SOCIAL
BEHAVIORAL AND ALSO IN CONTEXT,
AS DR. TITO WAS TALK ABOUT.
MY QUESTION THERE IS ABOUT, WHEN
YOU SAY INVOLVING THE COMMUNITY,
DO YOU HAVE A CONTEXT, IS IT A
COMMUNITY ENGAGED APPROACH WHERE
THERE WILL BE MULTIPLE PARTNERS
THAT ARE TRULY TRANSDISCIPLINARY
AFFECTING HOUSING AND FOOD
SECURITY, FOR EXAMPLE.
>> SO, WE WILL HAVE COMMUNITY
PARTNERSHIPS, SO WE WOULD LIKE
THE COMMUNITY TO BE INVOLVED
FROM THE BEGINNING, FROM THE
UNSEPTION OF THE CENTERS OF
EXCELLENCE AND TO REFLECT A TRUE
PARTNERSHIP WITH THE RESEARCHERS
IN THAT AREA.
THERE'S POTENTIAL FOR US TO
INCLUDE OTHER AGENCIES WITHIN
HHS SO THAT WOULD BE SOMETHING
THAT WE ARE CONSIDERING AND WE
ARE IN COMMUNICATION WITH OTHER
AGENCIES TO PARTNER WITH US.
>> THAT'S EXCELLENT.
I STRONGLY ENCOURAGE THAT.
THANK YOU.
>> THANK YOU.
>> OTHER QUESTIONS?
IF NOT, MAY I HAVE A MOTION FOR
APPROVAL?
>> NOTION APPROVE.
>> THANK YOU.
>> SECOND.
>> THANK YOU.
PLEASE VOTE NOW USING THE
BUTTONS AT THE BOTTOM OF THE
PANEL.
>> WE HAVE 1 16 YESES.
>> THANK YOU.
NEXT WE HAVE NICHD LABORATORY OF
DEVELOPMENTAL BIOLOGY.
ROBBIE.
>> CAN YOU HEAR ME?
>> YES, WE CAN HEAR YOU NOW.
>> THANK YOU, DENNIS.
PROGRAM SEEKS APPROVAL FOR AN
INITIATIVE TITLES NICHD
LABORATORY OF DEVELOPMENTAL
BIOLOBIOLOGY.
IT IS A RESOURCE THAT SPOT
SUPPORTS PROJECTS WHICH ENHANCE
THE CAPABILITIES OF ON GOING
BASIC TRANSLATION OF CLINICAL
RESEARCH IN THE FIELD OF HUMAN
DEVELOPMENTAL BIOLOGY.
THIS RESEARCH COLLECTS, PREPARES
AND DISTRIBUTES HUMAN TISSUES
AND TO THE SCIENTIFIC COMMUNITY.
THIS RESOURCE HAS SERVED THE
SCIENTIFIC COMMUNITY FOR THE
PAST 55 YEARS AND THE RESOURCE
NEEDS TO BE SUSTAINED AS IT
FACILITATES ACCESS TO OTHER WAYS
TO FIND FETAL TISSUES WHILE
ADHERING TO THE HIGHEST ETHICAL
AND REGULATORY STANDARDS.
THERE IS TISSUES, DIFFERENT
TIMES WITH DNA AND PROTEINS.
OVER THE LAST FEW YEARS IT HAS
PRODUCED -- ESSENTIAL FOR MAKER
PROJECTS SUCH AS IMPORT, ROAD
MAP AND BRAIN SCAN, A CLASS OF
DEVELOPING HUMAN BRAIN AND
MULTIPLE AND EXPANDED PROJECTS.
A SINGLE CENTRALIZED RESOURCE
ENSURE THE MATERIAL IS COLLECTED
AND PROCESSED APPROPRIATELY AND
CONSISTENTLY.
THIS IS BEING DEVELOPED IN OTHER
COMPANIES, SUSTAINING THIS
IMPORTANT RESOURCE.
THE PROPOSED CONCEPT YOU A LINED
TO THE NICHD STRATEGIC PLAN 2020
THEME ONE, UNDERSTANDING THE
BASIS OF DEVELOPMENT, THEME TWO,
PROMOTING REPRODUCTIVE HEALTH
AND THEME THREE, HEALTHY AND
LIFE LONG WELLNESS.
THE CONCEPT ALIGNS WITH
PRIORITIES OF MULTIPLE BRANCHES
WITHIN NICHD.
DEVELOPMENTAL BIOLOGY AND
ANOMALIES BRANCH, THAT IS
FERTILITY BRANCH AND
INTELLECTUAL DEVELOPMENTAL AND
DISABILITIES BRANCH, AND
PREGNANCY GROWTH AND NUTRITION
BRANCH.
THANK YOU.
>> THANK YOU, ROBBIE.
ARE THERE QUESTIONS OR COMMENTS
ABOUT THIS CONCEPT?
>> YEAH.
I JUST HAD A QUICK QUESTION.
HOW OFTEN DOES THIS LABORATORY
NEED APPROVAL FROM COUNCIL?
>> EVERY FIVE YEARS THIS WAS
LAST APPROVED IN 2017.
>> OKAY.
ALL RIGHT.
THANK YOU VERY MUCH.
IT SEEMS LIKE A GREAT RESOURCE
CONSIDERING THAT IT'S BEEN IN
EXISTENCE FOR 55 YEARS, SO THANK
YOU VERY MUCH.
>> I ALSO THINK THIS IS A GREAT
RESOURCE TO HAVE.
MY ONLY QUESTION IS, IS THERE A
SINGLE SITE FOR THE REPOSITORY?
I ASK BECAUSE THERE WAS A
DISASTER THAT OCCURRED FIVE, 10
YEARS AGO WITH BRAIN BANKS AND I
WONDER IF THAT WOULD BE USEFUL
AT THIS TIME.
>> CURRENTLY IT IS ONLY ONE
SITE.
>> ANY OTHER QUESTIONS?
>> JUST ADD TO THAT, QUICKLY, I
WOULD JUST ADD TO CONSIDER THIS,
AT LEAST, AS YOU'RE FUNDING THE
SITE, TO HAVE SOME REDUNDANCY.
>> OKAY SO NOTED.
NO OTHER QUESTIONS, MAY I HAVE A
MOTION FOR APPROVAL?
>> MOTION.
>> SECOND?
>> SECOND.
>> VERY GOOD.
PLEASE CAST YOUR VOTES NOW.
>> I'M SHOWING 15 YE YESES.
>> VERY GOOD.
THANK YOU, ROBBIE.
NEXT UP WE HAVE DR. IZENBURG
FROM THE FERTILITY AND INFERT
INFERTILITY BRANCH.
>> GOOD AFTERNOON.
PROGRAM SEEKS COUNCIL APPROVAL
OF AN INITIATIVE TITLED THE
RETROPRODUCTIVE SCIENTIST
DEVELOPMENT PROGRAM, A NATIONAL
CAREER DEVELOPMENT PROGRAM
DESIGNED TO PROVIDE SUPPORT FOR
OBSTETRICIAN GYNECOLOGISTS
WHITED TO A CAREER CONDUCTING
BASIC TRANSLATIONAL RESEARCH ON
WOMEN'S HEALTH-RELATED ISSUES.
THE GOAL OF THE RSDP IS TO
DEVELOP PHYSICIAN SCIENTISTS
BASED IN ACADEMIC SETTINGS WHO
CAN EMPLOY CUTTING EDGE
TECHNOLOGIES TO ADDRESS
IMPORTANT PROBLEMS IN OB-GYN AND
RELATED SUB SPECIALTIES AND
ULTIMATELY INCREASE THE PIPELINE
OF TRANSLATIONAL RESEARCHERS WHO
CONTRIBUTE TO THE SCIENTIFIC
MISSION OF NICHD.
SINCE UNSEPTION, OVER 112
CLINICAL FELLOWS OR SCHOLARS IN
A RANGE OF SPECIALTIES HAVE
PARTICIPATED.
APPROXIMATELY 75% OF THE
SCHOLARS SUBSEQUENTLY APPLIED
FOR RESEARCH GRANTS WITH HALF
RECEIVING AN AWARD.
08% OF FORMER SCHOLARS REMAINED
IN ACADEMIC OR RESEARCH RELATED
POSITIONS WITH MANY IN
LEADERSHIP ROLES.
OUR GOAL FOR THIS INITIATIVE IS
PARTICIPATION, RESEARCHER OF
DIVERSE BACKGROUNDS AS MENTORS
AND SCHOLARS, INCLUDING RACIAL
AND ETHNIC MINORITIES, PERSONS
WITH DISABILITIES AND WOMEN THIS
CONCEPT ALIGNS WITH THE NICHD
STRATEGIC PLAN THEME TWO AND
FACILITATES TRAINING AND
DEVELOPMENT OF AN INCLUSIVE AND
SCIENTIFIC WORKFORCE.
THANK YOU.
>> THANK YOU.
QUESTIONS OR COMMENTS ABOUT THIS
CONCEPT?
DR. MATSIK.
>> YES, I JUST WANTED TO SAY
THIS IS A GREAT PROGRAM.
HAVING TRAINED TWO INDIVIDUALS
WHO ARE -- WHO CAME THROUGH THE
PROGRAM AND STILL ARE DOING
RESEARCH AND HAVE GOTTEN NIH
GRANTS, I THINK IT IS A GREAT
PROGRAM AND I'M VERY ENCOURAGING
THAT IT IS BEING RENEWED.
>> THANK YOU.
>> DR. ROWICH.
>> REMEMBER AT A PREVIOUS
MEETING WE HAD AN IN DEPTH
DISCUSSION ABOUT THE PEDIATRIC
SCIENTIST DEVELOPMENT PROGRAM.
I'M WONDERING, DOES RSDP UNDER
GO THE SAME REVIEW AT RSDP.
>> IT UNDER G SCIENTIFIC
REVIEW.
AM I INTERPRETING THE QUESTION
CORRECTLY?
>> EXACTLY.
I'M CURIOUS BUT A WE WENT INTO
THE DETAILS OF THE VIEW FOR DSDP
SO THIS HAS AN ENCOURAGING SCORE
FROM EXTERNAL.
>> THIS IS THE CONCEPT THAT THE
PROGRAMS WOULD GET EXCELLENT
SCORES.
>> SORRY, I MISSED INTO.
MISUNDER STOOD.
THAT'S MY MISTAKE.
I TAKE BACK M COMMENT.
>> ANY OTHER ECONOMIES?
IF NOT, A MOTION FOR APPROVAL?
>> MOTION.
>> THANK YOU.
SECOND?
>> SECOND.
>> THANK YOU.
PLEASE VOTE NOW.
>> I'M SHOWING 16 YESES.
>> THANK YOU.
NEXT UP, DEVELOPMENTAL BIOLOGY
FOR SMALL RESEARCH GRANTS FOR
GABRIELLEA RESEARCH.
>> CANCERS ARE THE LEADING
CAUSES OF DEATH AMONG CHILDREN
AND PRESENT WIDE RANGE OF
PEDIATRIC CONDITIONS WITH CON
FLEX IDEOLOGIES TO WHICH LITTLE
IS KNOWN TOMORROW ACCELERATE
RESEARCH ON THESE CONDITIONS AND
IN RESPONSE TO THE MILLER KIDS
FIRST ACT THE FUND ESTABLISHED
THE MILLER KIDS FIRST PEDIATRIC
RESEARCH PROGRAM THIS PROGRAM IS
LED BY NICHD, NCI, NHLBI AND
NHGRI ALONG WITH A WORKING GROUP
OF REPRESENTATIVES FROM 12 NIH
INSTITUTES, THE OFFICE OF THE
DIRECTOR AND THE CENTERS FOR
DISEASE CONTROL AND PREVENTION.
THE KIDS FIRST PROGRAM HAS
DEVELOPED A DATA RESOURCE
CENTER, DATA RESOURCES IN THE
CLOUD, SEQUENCING CENTERS AND
SUPPORT TOTAL GEANOME AND OTHER
DATA FROM COHORTS OF BIRTH
DEFECT AND PEDIATRIC CANCER
PATIENTS THEIR THEIR FAMILIES.
SAMPLES FROM THE CHILDREN
AFFECTED WITH CANCER OR
STRUCTURAL BIRTH DEFECTS ARE
AVAILABLE FOR ANALYSIS.
MORE THAN 30,000 ADDITIONAL
WHOLE JE GENOME RESOURCES, THE
LARGEST COLLECTION OF PETE I
CAN'TPEDIATRICDATA.
BUT RESOURCES HAVE BEEN RIDGED
IN SCOPE AND LIMITED TO
DEVELOPMENT OF DATA RESEARCH.
THIS PROPOSAL FOCUSES ON THE
ANALYSIS OF THE DATA SETS MADE
AVAILABLE BY KIDS FIRST.
THE INTENT IS TO PROMODE
MERITORIOUS RESEARCH PROJECTS
THAT INVOLVED SECONDARY ANALYSIS
OF DATA SETS ASSEMBLED AND
DISSEMINATED BY THE KIDS FIRST
PROGRAM.
THESE DATA AND OTHER RESOURCES
HAVE BEEN DEVELOPED TO PROMOTE
DATA SHARING, DATA ANALYSIS AND
DATA VISUALIZATION TO ENABLE A
DEEPER EXPLORATION OF THE
ORIGINS ARE OF BIRTH DEFECTS AND
CHILDHOOD CANCERS AND ULTIMATELY
AN UNDERSTANDING OF THE ETIOLOGY
OF THESE CONDITIONS, THUS
EMPOWERING BETTER PREVENTION,
DIAGNOSTICS AND TREATMENTS FOR
THESE PEDIATRIC CONDITIONS.
>> THANK YOU.
ARE THERE QUESTIONS OR COMMENTS?
>> YES, I JUST WANTED TO SAY HOW
SUPPORTIVE I AM OF THIS CONCEPT.
IT'S BEEN GOING ON, WE'VE
REVIEWED SEVERAL PROPOSALS IN
THE PAST ON COUNCIL, AND YOU
KNOW, I'M SURE YOU ARE ALL AWARE
THERE ARE A NUMBER OF GENOME
SEQUENCING PROJECTS AND THEY
INVOLVE CHILDREN SO THIS MILLER
KIDS FORCE PROGRAM IS SO UNIQUE
AND IMPORTANT TO FOCUS ON KIDS
WITH BIRTH DEFECTS IN CHILDREN
SO I THINK THE ANALYSIS IS SO
IMPORTANT.
IF CHILD HEALTH DOES DO THIS, IT
IS NOT GOING TO GET DONE.
SO THANK YOU.
>> THANK YOU.
>> OTHER QUESTIONS?
IF NOT, MAY I HAVE A MOTION TO
APPROVE.
>> SO MOVED.
>> SECOND?
>> SECOND.
>> THANK YOU.
PLEASE REGISTER YOUR VOTES.
>> I'M SHOWING 16 YESES.
>> VERY GOOD, THANK YOU.
NEXT UP, THE CONTRACEPTION'
SEARCH BRANCH WHO WI WILL PRESET
BIOLOGICAL TEST FACILITY.
>> THE PURPOSE OF THIS
INITIATIVE IS TO PROVIDE
INVESTIGATOR A MEANS TO REQUEST
FROM A CONTRACT RESEARCH THAT
SILLITY IN THE DEVELOPMENT OF
CONTRACEPTIVESES, A PRODUCT WITH
ANTI-HIV OR ANTI-INIF HE CANTIVE
PROBABILITIES.
IT IS NOT LIMITED TO
PHARMACOLOGY, TOXICOLOGY AND
FERTILITY STUDIES.
CONTRACTOR UTILIZED A WIDE
VARIETY OF ANIMAL SPECIES.
THE OVER REACH IS TO GENERATE
NEW ENTRY INTO THE FIELD WITH
PRELIMINARY DATA FOR A FIRST
OPPORTUNITY AND SENIOR
INVESTIGATORS FOR THEIR NEXT
FUNDING OPPORTUNITY.
CURRENT FUNDING WILL NOT BE A
PRESECONDPREREQUISITE TO APPLY.
IT PROVIDES JUNIOR AND SENIOR
INVESTIGATORS INCLUDING INVIE
TROAND PHARMA STUDIES, FERTILITY
TESTING, TOXICOLOGY AND
FORMULATION.
DATA FROM THESE SERVICE REQUEST
CONTRIBUTE FROM R-01 AND FUNDING
FROM USAID THIS SERVICE REQUEST
WILL BE RECEIVE FOR MULTI
PREVENTION TECHNOLOGIES AND IT
IS EXPECTED SOME OF THESE ARE OF
INTEREST AND VALUE TO THE
PEDIATRIC INFECTIOUS DISEASE
BRANCH.
THIS ALIGN WITH THE PLAN, THEM
TWO, REPRODUCTIVE HEALTH AND
THEME FOUR FOR THE DEVELOPMENT
OF SAFE AND EFFECTIVE
THERAPEUTICS.
AS WELL AS THE CONTRACEPTIVE
RESEARCH PRIOR OF DEVELOPING NEW
AND IMPROVED CONTRACEPTIVESES.
THANK YOU.
>> THANK YOU.
QUESTIONS OR COMMENTS ABOUT THIS
CONCEPT?
IF NOT, MAY I HAVE A MOME MOTIOR
APPROVAL?
>> MOTION.
>> SECOND?
>> SECOND.
>> THANK YOU.
PLEASE REGISTER YOUR VOTES NOW.
>> I'M SHOWING 16 YESES.
>> VERY GOOD.
AND TO FINISH UP THE CONCEPTS,
WE HAVE DR. CHRIS LINDSEY WHO IS
ALSO FROM THE CONTRACEPTION
RESEARCH BRANCH AND WILL PRESENT
CHEMICAL SCREENING AND
OPTIMIZATION FACILITY.
CHRIS.
>> HELLO.
PROGRAM SAKES COUNSEL APPROVAL
FOR AN INITIATIVE TITLED
CHEMICAL SCREENING AND
OPTIMIZATION FACILITY, WHOSE
PURPOSE IS TO PROVIDE
INVESTIGATORS A MEANS TO REQUEST
SERVICES FROM A STATE OF THE ART
CONTRACT RESEARCH FACILITY WITH
THE CAPABILITIES AND CHRISTMAS
TO ADVANCE NON-HORMONAL
CONTRACEPTIVE AND/OR
REPRODUCTIVE HEALTH RELATE RED
SEARCH PROGRAMS.
REQUESTED SERVICES INCLUDE
ROUTINE EXPRESSION, HIGH
THROUGH-PUT SCREENING, STRUCTURE
ACTIVITY RELATIONSHIPS AND
SCALABLE CANTIES.
THE OVER ARCHING GOAL IS TO
FACILE AT THIS TIME NEW
INVESTIGATOR ENTRY INTO THESE
FIELD BUS GENERATING PRELIMINARY
DATA FOR A FIRST FUNDING
OPPORTUNITY AND PROVIDING
BRIDGING STUDIES FOR SENIOR
INVESTIGATORS FOR THEIR NEXT
FUNDING OPPORTUNITY.
CURRENT FUND STAG TUS WILL NOT G
STATUS WILL NOT AND PREREQUISITE
TO AEMPLOYEE.
THIS IS FOLLOWING A CALL FROM
THE PUBLIC FOR NON-HORMONAL
THERAPIES THAT PEOPLE CAN USE
THROUGHOUT THEIR REPRODUCTIVE
LIVES.
PROGRAM SEEKS TO CONTINUE THIS
EFFORT.
SERVICE PROVIDED IN THE LAST
CYCLE TO SEVERAL JUNIOR AND
SENIOR INVESTIGATORS INCLUDE,
CHEMICAL OPTIMIZATION, MATERIALS
SUMP AS DNA, ANTIBODIES AND
NATURAL PRODUCTS, HIGH THROUGH
PUT SCREENING AND MULTI GRAM
QUANTITIES TO IDENTIFY SMALL
MOLECULES THIS CONTRIBUTED TO I
WARDED APPLICATIONS THIS CONCEPT
CLEARANCE ALIGN WITH THE NICHD
STRATEGIC PLAN THEME TWO
REPRODUCTIVE HEALTH, AND THEME
4, SAFE AND EFFECTIVE
THERAPEUTICS AND THE DEVELOPMENT
OF NEW AND IMPROVED
CONTRACEPTIVES.
CONCERNING ALIGNMENT WITH THE
HIV PRIORITIES, IT IS
CONCEIVABLE THIS TECHNOLOGY THAT
IS A CONTRACEPTIVE WITH
ANTI-INIF INFECTIVE POSE COULDE
RECEIVED BUT IS NOT KNOWN.
>> THANK YOU.
ANY QUESTIONS OR COMMENTS.
>> COULD YOU EXPLAIN, CHRIS, IT
SOUNDS LIKE THIS IS A RENEWAL.
HOW IS THIS DIFFERENT THAN THE
ONE WE JUST HEARD ABOUT WITH BIO
LOGIC TESTING AND DO THESE WORK
TOGETHER.
>> SO THAT'S A GREAT QUESTION.
SO THE WHERE TO SOMEWHAT
DISTINGUISHED.
FOR THE BIOLOGICAL TEST FACILITY
AS A CONCEPT WOULD BE PRIORI
PRIORITIZING IN-VIVO STUDIES
OPPOSED TO THE CHEMICAL FACILITY
IS PRIORITIZING, AS A MEDICINAL
CHEMIST, CHEMICAL OPTIMIZATION.
A LITTLE BIT OF OVERLAP BUT FOR
THE MOST PART THAT'S WHERE WE
DISTINGUISH IT.
SO INVIVO TESTING WOULD BE IN
THE BIOLOGICAL TESTING STUDY,
OPTIMIZATION OF A DEFINED
CHEMICAL ENTITY WOULD BE IN THE
CHEMICAL OPTIMIZATION FACILITY.
>> THANK YOU FOR CLARIFYING.
>> YOU'RE WELCOME.
>> ANY OTHER QUESTIONS FOR
CHRIS?
IF NOT, MAY I HAVE A MOTION FOR
APPROVAL?
>> I MAKE A MOTION TO APPROVE.
>> SECOND.
>> THANK YOU.
ARE PLEASE REGISTER YOUR VOTES
ON THE ZOOM PANEL.
>> I'M SHOWING 16 YESES.
>> OKAY.
VERY GOOD.
THANKS, EVERYBODY THIS CONCLUDES
THE OPEN SESSION OF OUR AGENDA.
AT THIS TIME WE NEED TO TAKE A
QUICK 15-MINUTE BREAK TO MAKE
THE TRANSITION FROM THE OPEN
SESSION TO THE CLOSED SESSION.