ALL RIGHT.
GOOD AFTERNOON, EVERYONE.
WELCOME TO EVERYONE JOINING TO
THE OPEN SESSION OF THE NDCD
ADVISORY COUNCIL.
REMINDER, THIS OPEN SESSION OF
THE MEETING IS BEING VIDEOCAST
LIVE.
IT WILL ALSO BE ARCHIVED FOR
VIEWING BY MEMBERS OF THE PUBLIC
AND NIH STAFF FOR ONE YEAR.
SO, AS ALWAYS, WE WILL START
WITH ADMINISTRATIVE ISSUES, AND
I'M HAPPY TO BEGIN THE PROGRAM
WITH INTRODUCTIONS OF THE
COUNCIL MEMBERS.
I WILL CALL ON EACH MEMBER OF
THE COUNCIL AND ASK YOU TO TURN
ON YOUR VIDEO, STATE YOUR NAME
AND AFFILIATION, AND JUST SAY A
COUPLE WORDS ABOUT YOUR
EXPERTISE.
AND WE'LL START WITH DR. LINDA
BARLOW.
I THINK EVERYBODY IS TRYING TO
FIGURE OUT HOW IN TEAMS TO TURN
ON THEIR VIDEO.
IS SHE HERE?
>> SHE WAS HERE BUT I DON'T SEE
HER HERE ANYMORE.
>> I MADE HER A PRESENTER.
>> I'LL COME BACK TO HER.
>> THERE'S A LOT OF MEMBERS WHO
HAVEN'T FIGURED OUT HOW TO JOIN
YET, YOU MAY END UP QUITE A FEW
PEOPLE TRYING TO .
>> OH NO.
OKAY, ALL RIGHT.
WELL, WHAT WE COULD DO, WE HAVE
TO TAKE A VOTE NEXT ON THE
MINUTES, SO I'M NOT SURE WE WANT
TO DO THAT WITHOUT PEOPLE
PRESENT EITHER.
I'LL GO THROUGH THE LIST, I SEE
SOME MEMBERS OF THE COUNCIL
HERE, WE'LL SEE WHO CAN
INTRODUCE THEMSELVES AND PICK
UP.
SO, DR. BARLOW'S NOT HERE, I
THINK, KATHERINE BOOTEN IS NOT
ABLE TO AFTERNOON.
DR. EMILY BUSS, I SEE EMILY.
>> YES, I'M HERE.
EMILY BUSS, UNIVERSITY OF NORTH
CAROLINA, AT CHAPEL HILL, AND I
STUDY HUMAN HEARING WITH A FOCUS
ON AUDITORY DEVELOPMENT AND
EFFECTS OF HEARING LOSS.
>> GREAT.
THANK YOU.
NEXT MISS VICKIE DEAL WILLIAMS.
I SEE HER NAME BUT I THINK SHE'S
NOT QUITE HERE YET.
>> I AM HERE.
TRYING TO GET TO THE BUTTONS.
I'M VICKIE DEAL WILLIAMS, CHIEF
EXECUTIVE OFFICER AT THE
AMERICAN SPEECH LANGUAGE HEARING
ASSOCIATION.
>> THANK YOU.
DR. JAY GOTTFRIED.
DO NOT SEE HIM.
HOW ABOUT DR. ANDY BROAST?
DR. KIA JOHNSON?
>> SHE DOESN'T SEEM TO HAVE ANY
SOUND.
>> ANDY --
>> HE'S HERE.
>> OKAY.
>> WE CAN'T SEEM TO HEAR HIM.
>> MY NAME IS KIA JOHNSON,
DIRECTOR OF ARTHUR BLANK CENTER
FOR STUTTERING EDUCATION AND
RESEARCH, AFFILIATED WITH
UNIVERSITY OF TEXAS AUSTIN, AREA
IS STUTTERING IN CULTURAL
DIVERSE COMMUNITIES.
GLAD TO BE HERE.
>> THANK YOU.
DR. KIRAN?
>> HOPEFULLY YOU CAN HEAR ME,
SWATHI KIRAN, BOSTON UNIVERSITY,
DIRECTOR FOR CENTER FOR BRAIN
RECOVERY, AREA OF EXPERTISE IS
APHASIA.
>> NEXT IS DR. OWANI WHO WAS NOT
ABLE TO JOIN US THIS AFTERNOON.
>> DR. DAN MORFELD, OHIO STATE
UNIVERSITY, MY AREA IS BALANCE
AND SPATIAL ORIENTATION.
>> JAY PICARELLO, PROFESSOR AT
WASHINGTON UNIVERSITY,
ST. LOUIS, PRACTICING
OTOLARYNGOLOGIST, CLINICAL
TRIALS IN TINNITUS,
COVID-RELATED ANOSMIA AND DIRECT
THREE CLINICAL RESEARCH TRAINING
PROGRAMS, TWO R25s AND OUR
INSTITUTIONAL CTSA TL-1.
THANK YOU.
>> THANK YOU.
NEXT DR. RAMIREZ STAPLETON.
WE'LL COME BACK TO HER.
>> NOT HERE YET, OKAY.
>> AND DR. MARIO SVIRSKY, IS HE
SNEER.
>> I DON'T THINK MARIO IS HERE
YET.
>> DR. TUESDAY AN THIBEAULT.
>> I'M HERE.
SUSAN THIBEAULT, PROFESSOR OF
OTOLARYNGOLOGY, NECK SURGERY,
UNIVERSITY
UNIVERSITY OF WISCONSIN, I STUDY
IMMUNOLOGY AND DEVELOPMENT OF
LARYNX.
>> DR. LARRY TRUSSELL?
>> HELLO, EVERYONE.
I'M LARRY TRUSSELL, PROFESSOR AT
OREGON HEALTH SCIENCE UNIVERSITY
IN PORTLAND, OREGON.
AND INTERIM DIRECTOR OF OREGON
HEARING RESEARCH CENTER.
AND MY SPECIALTY FOR RESEARCH IS
IN THE MOLECULAR BIOLOGY AND
BIOPHYSICS AND PHYSIOLOGY OF
CENTRAL AUDITORY NEURONS.
>> THANK YOU.
DR. WALLHAGEN, I'M NOT SURE IF
SHE WAS GOING TO BE HERE.
AND DR. NANCY YOUNG.
>> I'M HERE.
I JUST JOINED.
>> I'M SORRY.
>> I HAD TROUBLE GETTING IN.
BUT I DID FINALLY MAKE IT IN.
OH, MEG WALLHAGEN, UC-SAN
FRANCISCO, SCHOOL OF NURSING.
AND IN GERIATRICS.
>> GREAT.
THANK YOU.
NANCY YOUNG, DR. NANCY YOUNG.
>> GOOD AFTERNOON.
I'M NANCY YOUNG, A SURGEON AT
LURIE CHILDREN'S HOSPITAL IN
CHICAGO, WHERE I AM THE HEAD OF
OTOLY IN THE DIVISION OF
OTOLARYNGOLOGY, PROFESSOR AT
NORTHWESTERN UNIVERSITY.
AND MY AREA OF RESEARCH INTEREST
IS NEUROPLASTICITY OF CHILDREN
WITH HEARING LOSS AND PREDICTING
LANGUAGE OUTCOMES.
>> THANK YOU.
WE HAVE TWO EX OFFICIO MEMBERS
WHO REPRESENT OUR FEDERAL
PARTNERS.
THE FIRST IS DR. SEAN
McCLENNEY.
>> HE WAS HAVING TROUBLE GETTING
INTO THE MEETING, MAY NOT BE IN
YET.
>> AND FROM THE DEPARTMENT OF
DEFENSE, NOT HERE.
I'LL SEE IF THE FIVE PEOPLE NOT
HERE INITIALLY ARE HERE.
DR. LINDA BARLOW, ARE YOU HERE?
DR. JAY GOTTFRIED?
DR. ANDY GROVES?
>> STILL CAN'T HEAR YOU, ANDY.
>> ALL RIGHT.
I'M SORRY, ANDY.
DR. RAMIREZ STAPLETON?
AND DR. MARIO SVIRSKY.
THANK YOU ALL FOR YOUR SERVICE
AND FOR ALL OF THE EXPERTISE
THAT YOU CONTRIBUTE TO THIS
COUNCIL.
WE'LL MOVE ON NEXT, I THINK
WE'RE READY FOR THE SLIDES
AGAIN.
AND THE CONSIDERATION OF THE
COUNCIL OPERATING PROCEDURES,
AND THE MINUTES FROM OUR LAST
MEETING, WHICH WAS HEALTH
SEPTEMBER 12.
A COUPLE MORE SLIDES.
OKAY.
HERE WE GO.
ALL RIGHT.
SO WE HAVE TWO THINGS TO VOTE ON
HERE.
EVERY WINTER WE VOTE ON OUR
COUNCIL OPERATING PROCEDURES,
BECAUSE WE DID NOT MEET FOR THE
OPEN SESSION?
JANUARY WE'RE BRINGING THEM TO
YOU NOW.
THERE WERE NO CHANGES PROPOSED
FOR THIS YEAR BUT WE STILL DO
NEED TO APPROVE THESE OPERATING
PROCEDURES.
SO I'M LOOKING FOR A PROPOSAL TO
APPROVE AND A SECOND, AND ALL IN
FAVOR.
SO EMILY?
OKAY.
I SEE A LOT OF HANDS UP.
ANY OBJECTIONS?
OKAY.
ALL RIGHT.
AND THE MINUTES FROM THE LAST
MEETING, WHICH WAS SEPTEMBER 12
OF 2024, CAN BE FOUND IN THE
ELECTRONIC COUNCIL BOOK.
I'LL HAVE THE HANDS GO DOWN.
AND THEN COME UP AGAIN TO
PROPOSE APPROVAL OF THOSE
MINUTES, A SECOND, AND THEN ALL
IN FAVOR.
THANK YOU.
ANY OPPOSED?
OKAY.
ALL RIGHT.
SO WE'LL MOVE TO THE NEXT SLIDE
WHICH SHOWS THE FUTURE MEETING
DATES OF THIS COUNCIL.
SO, WE HAVE TRIED TO VET THESE
WITH EVERY POSSIBLE CONFLICT
THAT WE KNOW ABOUT.
PLEASE LOOK AT THESE, ENTER THEM
IN YOUR CALENDAR AND LET US KNOW
IF YOU HAVE CONFLICTS.
THANK YOU.
ALL RIGHT.
NOW I WILL MOVE ALONG AND GIVE A
SHORT DIRECTOR'S REPORT.
AND WE'LL GO TO THE NEXT SLIDE.
SO, THERE HAVE BEEN MANY, MANY
CHANGES AT NIH.
AS YOU ALL KNOW.
AND I WANTED TO DRAW YOUR
ATTENTION TO THESE TWO
RESOURCES.
AND BOTH CAN BE ACCESSED WITH
THE LINK OR QR CODE, NIH
GRANTS & FUNDING INFORMATION
STATUS WEB PAGE HAS THE LATEST
STATUS OF CHANGES IMPACTING NIH
GRANTS, ADMINISTRATION, AND
FUNDING.
THEN THERE'S A TRACKING SENDING
WEBSITE THAT PROVIDES
INFORMATION ON NIH'S TERMINATED
GRANTS, ACCESSED THROUGH THE HHS
WEBSITE.
NEXT SLIDE PLEASE.
SO, AS I MENTIONED, WE HAVE HAD
MANY, MANY CHANGES IN ORDER TO
ALIGN NIH PRIORITIES AND FUNDING
MECHANISMS WITH ADMINISTRATION
PRIORITIES.
SO, WE ARE ACCEPTING
APPLICATIONS FOR ACTIVE FUNDING
OPPORTUNITIES, SOME FUNDING
OPPORTUNITIES AS YOU KNOW HAVE
BEEN CLOSED AND OTHERS HAVE BEEN
UPDATED IN ORDER TO ALIGN WITH
AGENCY PRIORITIES.
APPLICANTS ARE ENCOURAGED TO
CAREFULLY RE-READ FUNDING
OPPORTUNITIES TO NOTE ANY
CHANGES THAT HAVE BEEN MADE
PRIOR TO ANY SUBMISSIONS SO THAT
THEY CAN ADJUST THEIR
APPLICATIONS ACCORDINGLY.
WE NO LONGER REQUIRE AND WILL
NOT REVIEW PLANS FOR ENHANCING
DIVERSE PERSPECTIVES OR THE PEDP
PLANS, CONFERENCE GRANTS,
DIVERSITY PLANS, OR RECRUITMENT
PLANS TO ENHANCE DIVERSITY.
FEDERAL REGISTER NOTICES AND
MEETINGS ARE CURRENTLY ONGOING
FOR SCIENTIFIC REVIEW GROUPS AND
STUDY SECTIONS.
AND FEDERAL REGISTER NOTICES
HAVE RESUMED FOR NATIONAL
ADVISORY COUNCIL MEETINGS AND
BOARDS.
AND THAT'S WHY WE CAN HAVE THESE
MEETINGS TODAY AND TOMORROW.
FOR AWARDS WE'RE ISSUING AWARDS
FOR COMPETING, NON-COMPETING
CONTINUATION, AND ADMINISTRATIVE
SUPPLEMENTS USING PREVIOUSLY
APPROVED NEGOTIATED INDIRECT
COST RATES, EXCEPT FOR AWARDS
UNDER WHICH F & A COSTS ARE
REIMBURSED AT FIX THE RATES.
THAT'S AN UPDATE ON GRANTS.
NEXT SLIDE.
I WANT TO GIVE A WARM, WARM
WELCOME FROM NIDCD TO 18th
DIRECTOR OF THE NATIONAL
INSTITUTES OF HEALTH, DR. JAY
BHATTACHARYA.
DR. BHATTACHARYA ASSUMED THIS
OFFICE ON APRIL 1.
HE PREVIOUSLY WAS A TENURED
PROFESSOR IN THE MEDICAL SCHOOL
AT STANFORD UNIVERSITY IN
CALIFORNIA.
HIS RESEARCH HAS BEEN FUNDED
PRIMARILY BY THE NATIONAL NATIL
INSTITUTE ON AGING FOCUSED ON
POPULATION AGING AND CHRONIC
DISEASE, PARTICULARLY ON THE
HEALTH AND WELL-BEING OF
VULNERABLE POPULATIONS.
HIS APPROACH TO LEADING NIH IS
TO ENCOURAGE DIFFERENT
PERSPECTIVES AS PART OF HIS
LARGER MISSION TO RESTORE PUBLIC
TRUST IN SCIENCE.
AGAIN, WELCOME TO DR.
BHATTACHARYA.
AND THE NEXT SLIDE IS BOTH TO
THANK DR. MATT MEMOLI, WHO
SERVED AS ACTING DIRECTOR
JANUARY 22 TO MARCH 31, THE DAY
BEFORE DR. BHATTACHARYA ARRIVED,
AND HE HAS STAYED IN THE OFFICE
OF THE DIRECTOR AT NIH TO SERVE
AS PRINCIPAL DEPUTY DIRECTOR,
WHICH IS A ROLE THAT PREVIOUSLY
DR. LARRY TABAK SERVED IN FOR
MANY YEARS.
SO, HAS WORKED AT NIH FOR 20
YEARS, RECENTLY DIRECTOR OF
CLINICAL STUDIES UNIT IN THE
LABORATORY OF INFECTIOUS
DISEASES, PART OF THE NIH'S
NATIONAL INSTITUTE ON ALLERGY
AND INFECTIOUS DISEASE,
PREVIOUSLY STAFF CLINICIAN IN
THE SAME LAB, AND NOW HAS MOVED
TO THIS POSITION SO WE VERY MUCH
APPRECIATE HIS EFFORTS ON OUR
BEHALF AS WELL.
OKAY.
NEXT SLIDE.
SO, THIS IS SOME VERY, VERY
HAPPY NEWS.
PRESIDENT BIDEN HONORED TWO
NIDCD-FUNDED EARLY CAREER
SCIENTISTS, AND THESE SCIENTISTS
WERE AWARDED THE PRESIDENTIAL
EARLY CAREER AWARD FOR
SCIENTISTS AND ENGINEERS, THIS
IS A PROGRAM CALLED PECASE, THE
HIGHEST HONOR BESTOWED BY THE
U.S. GOVERNMENT ON OUTSTANDING
SCIENTISTS AND ENGINEERS EARLY
IN THEIR CAREERS.
AND JUST A LITTLE BIT OF
BACKGROUND ON THE PROGRAM, THIS
WAS ESTABLISHED BY PRESIDENT
CLINTON IN 1996, TO RECOGNIZE
SCIENTISTS AND ENGINEERS WHO
SHOW EXCEPTIONAL POTENTIAL FOR
LEADERSHIP EARLY IN THEIR
RESEARCH CAREERS.
THE AWARD RECOGNIZES INNOVATIVE
AND FAR-REACHING DEVELOPMENT IN
SCIENCE AND TECHNOLOGY, EXPANDS
AWARENESS OF CAREERS IN SCIENCE
AND ENGINEERING, RECOGNIZES
SCIENTIFIC MISSIONS OF
PARTICIPATING AGENCIES, ENHANCES
CONNECTIONS BETWEEN RESEARCH AND
IMPACTS ON SOCIETY AND
HIGHLIGHTS IMPORTANCE OF SCIENCE
AND TECHNOLOGY FOR OUR NATION'S
FUTURE.
SO WE WERE THRILLED TO HAVE TWO
NIDCD GRANT RECIPIENTS RECEIVE
THIS AWARD, DR. MATT BUSH, WHO
WORKS ON ACCESS TO HEARING
HEALTH CARE IN APPALACHIA, AND
ANNE TAKESIAN, ELECTRO CORTEX
PHYSIOLOGY.
CONGRATULATIONS TO BOTH
SCIENTISTS.
ANOTHER BIT OF EXCITING NEWS IS
THAT THE NATIONAL ACADEMIES OF
SCIENCE AND, ENGINEERING, AND
MEDICINE RECENTLY RELEASED A
REPORT MEASURING THE OUTCOMES IN
ADULT HEARING HEALTH
INTERVENTIONS.
THIS IS A CONSENSUS STUDY THAT
WAS COMMISSIONED PRIMARILY BY
NIDCD WITH PARTNERSHIPS WITH THE
CENTERS FOR DISEASE CONTROL AND
PREVENTION, DEFENSE HEALTH
AGENCY, DEPARTMENT OF VETERANS
AFFAIRS, AND NATIONAL INSTITUTE
ON AGING.
AND THE GOAL THAT WE WANTED TO
ACHIEVE IS TO ESTABLISH A
CONSENSUS ON MEANINGFUL OUTCOME
MEASURES IN ADULT HEARING HEALTH
CARE.
WE THINK THAT THIS IS A
MILESTONE FOR THE FIELD, AND
HOPE WILL SET THE STANDARD FOR
THOSE ENGAGED IN HEARING-RELATED
RESEARCH AND IN CLINICAL
PRACTICE.
SO, THIS REPORT WAS PUBLISHED
YESTERDAY, ON WEDNESDAY, MAY
7th, AND IS NOW AVAILABLE TO
DOWNLOAD FREE OF CHARGE, A
PUBLIC SEMINAR WILL BE HELD NEXT
WEEK ON MAY 12, MONDAY, AT 3
P.M.
AND THERE ARE MEMBERS OF THE
REPORT COMMITTEE THAT WILL SPEAK
AND ANSWER QUESTIONS FROM THE
AUDIENCE.
THAT WILL ALSO BE RECORDED AND
AVAILABLE ON THEIR WEBSITE IF
YOU'RE NOT AVAILABLE AT THAT
TIME AND WOULD LIKE TO ACCESS
THE RECORDING.
DR. KELLY KING HAS BEEN THE LEAD
ON THIS FROM NIDCD, AND WE WILL
ASK HER TO SPEAK MORE ABOUT THIS
IN FURTHER NIDCD PLANS AT A
FUTURE COUNCIL MEETING.
ALL RIGHT.
AND THE LAST ORDER OF BUSINESS
STARTS ON THE NEXT SLIDE, FOR
THE NEXT SEVERAL SLIDES.
AND THAT IS THAT I WOULD LIKE TO
CHARGE, REQUEST AND CHARGE, AN
NIDCD COUNCIL CLINICAL TRIALS
WORKING GROUP.
SO FROM TIME TO TIME, WE SEEK TO
LEVERAGE THE EXPERTISE AND
PERSPECTIVE OF MEMBERS OF OUR
COUNCIL AND MEMBERS OF OUR
RESEARCH COMMUNITY TO ADDRESS
CHALLENGES OF THE INSTITUTE.
SO, TODAY I WANT TO PROPOSE THIS
WORKING GROUP TO ANSWER
IMPORTANT QUESTIONS ABOUT HOW WE
SUPPORT CLINICAL TRIALS AT
NIDCD.
THIS IS A TOPIC OF BROAD
CONSIDERATION AND INTEREST
ACROSS NIH AT LARGE, AND SO IT'S
A TOPIC THAT'S NOT ONLY
CONSIDERED WITHIN OUR INSTITUTE
BUT ALSO WITHIN THE AGENCY AT
LARGE.
I'VE ASKED DR. JAY PICARIRLO TO
CO-CHAIR AND WE'LL BE WORKING
TOGETHER OVER THE COMING WEEKS
TO ASSEMBLE AN EXPERT PANEL TO
CONDUCT THIS WORK.
THE GROUP WILL INTERVIEW A
VARIETY OF INDIVIDUALS WHO HAVE
INTEREST AND EXPERTISE IN THIS
AREA OF OUR PORTFOLIO AND WILL
ISSUE A PUBLIC REPORT.
THE CHARGE TO THE GROUP IS SHOWN
HERE.
HOW CAN WE EXPAND AND SUPPORT
OUR APPLICANT POOL, WE WOULD
LIKE TO STIMULATE INTEREST AND
EXPERTISE IN THE GROUP OF
INVESTIGATORS WHO ARE DOING WORK
IN OUR MISSION AREAS SO THEY CAN
SUBMIT AND COMPLETE SUCCESSFUL
CLINICAL TRIALS.
SECOND, NIDCD FULFILLING NEEDS
OF RESEARCH COMMUNITY AND
STAKEHOLDERS, WHAT IS OUR
STRATEGIC DIRECTION, WHAT
MECHANISMS DO WE HAVE TO SUPPORT
CLINICAL TRIALS WITHIN NIDCD,
AND HOW CAN WE DO THIS BETTER?
AND THEN THIRD, ARE WE
LEVERAGING AVAILABLE RESOURCES
OPTIMALLY, AND WHAT RESOURCES
ARE NEEDED BY INVESTIGATORS WE
MIGHT PROVIDE THROUGH OUR OWN
EFFORTS OR THROUGH RESEARCH
ORGANIZATIONS, AS WELL AS NIH
RESOURCES SUCH AS IN NCATS AND
AS YOU WILL RECALL HEARING FROM
DR. JONI RUTTER ABOUT THE
PROGRAM THAT'S -- PROGRAMS THAT
THEY HAVE AVAILABLE IN NCATS.
NEXT SLIDE.
LAST MAY, DR. TRENDILY GAVE A
PRESENTATION AT COUNCIL MEETING,
GIVING INFORMATION ABOUT OUR
CURRENT CLINICAL TRIAL
PORTFOLIO.
NIDCD CURRENTLY FUNDS THE
MAJORITY OF CLINICAL TRIALS
THROUGH R01 AND U01 MECHANISMS.
LOWER RISK CLINICAL TRIALS
UTILIZE THE R01 MECHANISM, AND
IN THAT CASE THE PRINCIPAL
INVESTIGATORS INTERACT ONLY WITH
THE PROGRAM OFFICERS AND NOT
WITH THE CLINICAL TRIALS OFFICE,
OR THE MEDICAL OFFICERS.
THE U01 MECHANISM FUNDS HIGH
RISK CLINICAL TRIALS, AND THESE
ARE THE TRIALS SUPPORTED THROUGH
OUR CLINICAL TRIAL OFFICE, AND
I'LL DESCRIBE THAT OFFICE IN A
MOMENT.
SO, NIDCD CONSIDERS RISK IN
TERMS OF COMPLEXITY OF THE
TRIAL, SAFETY CONSIDERATIONS,
IMPACT, AND FISCAL INVESTMENT.
SO, AS YOU CAN SEE, THE GREAT
MAJORITY OF TRIALS ARE FUNDED
THROUGH THE R01 MECHANISM, AND
SO THAT'S SHOWN IN BLUE BARS.
BROKEN DOWN BY OUR MISSION
AREAS.
SO WE HAVE MANY MORE R01-FUNDED
CLINICAL TRIALS THAN U01s
SHOWN IN THE ORANGE BOXES.
I'LL MENTION ALSO THAT SOME OF
YOU ARE AWARE OF AN NIH-DESIGNED
CATEGORY, BASIC EXPERIMENTAL
STUDIES INVOLVING HUMANS, BESH,
NOT INTERVENTIONAL TRIALS, AND
THEY ARE ALSO INCLUDED IN THIS
NUMBER OF LOWER RISK R01s.
NEXT SLIDE.
THIS SHOWS THE CHARACTERISTICS
OF THE U01 CLINICAL TRIALS, THE
TRIALS THAT WE'LL BE CONSIDERING
IN THE WORKING GROUP BECAUSE
THEY ARE THE ONES SUPPORTED BY
OUR CLINICAL TRIALS OFFICE.
AND SO THEY MAY HAVE A FEW OF
THESE FEATURES, ONE REQUIRES FDA
OVERSIGHT, SUCH AS THOSE THAT
REQUIRE AN INVESTIGATIONAL NEW
DRUG, IND, OR INVESTIGATIONAL
DEVICE EXEMPTION, IDE,
APPLICATION.
THEY MAY HAVE HIGHER RISKS TO
PARTICIPATE, PARTICULARLY IN OUR
PORTFOLIO THEY MAY INVOLVE A
SURGICAL INTERVENTION.
THEY COULD BE A PIVOTAL CLINICAL
TRIAL, SUCH AS BE A NIH DEFINED
PHASE 3 CLINICAL TRIAL FOR
SAFETY AND EFFECTIVENESS OF NEW
PROPOSED TREATMENT AND THIS
INCLUDES APPLICATIONS THAT
EXCEED THE ANNUAL DIRECT COST OF
$700,000.
NEXT SLIDE.
FOR THESE THE TOTAL NUMBER OF
PROJECTS, NIDCD SUPPORTED U01
CLINICAL TRIALS.
OVER THE LAST TEN YEARS.
SO YOU CAN SEE THAT IN 2024,
WE'RE AT 13 TRIALS.
THIS IS DOWN SLIGHTLY.
A CONCERNING ISSUE IS THAT WE'RE
DUE TO WRAP UP FOUR U01s THIS
FISCAL YEAR, SO THAT NUMBER WILL
GO DOWN.
AND WE DO NOT HAVE U01s IN THE
PIPELINE AT THIS TIME.
SO THE LAST SUCCESSFUL. WAS
SUBMITTED IN JUNE OF 2022,
AWARDED IN AUGUST OF 2023.
SINCE THEN THERE HAVE BEEN SEVEN
APPLICATIONS, AND NONE OF THESE
HAVE SCORED WELL ENOUGH TO BE
FUNDED.
SO, THAT IS OF CONCERN TO ME AND
TO OUR STAFF.
NEXT SLIDE PLEASE.
THIS SHOWS NIDCD-SUPPORTED
CLINICAL TRIALS BY AREA, BY
MISSION AREA, OVER THE LAST TEN
YEARS SO YOU CAN SEE IF YOU LOOK
AT 2015 MOST OF THESE TRIALS
WERE IN HEARING AND BALANCE.
AND OVER THE INTERVENING YEARS,
THIS HAS BECOME MORE BALANCED
BETWEEN THE VOICE, SPEECH AND
LANGUAGE PORTFOLIO AND THE
HEARING AND BALANCE PORTFOLIO,
SO THAT VOICE, SPEECH AND
LANGUAGE DOMINATE, STILL WITH
JUST ONE TRIAL IN THE CONSENSUS
SO THE PORTFOLIO CHANGED OVER
TIME IN THAT WAY.
NEXT SLIDE.
I THINK THIS IS OF HAVE BECAUSE
IT GIVES A LITTLE BIT OF INSIGHT
INTO THE KINDS OF U01 CLINICAL
TRIALS THAT WE FUND.
SO, THIS IS SHOWING DIFFERENCES
BY TYPE OF INTERVENTION,
INCLUDING DEVICE TRIALS, DRUG
TRIALS, BEHAVIORAL TRIALS, AND
NUTRITIONAL TRIALS.
AND YOU CAN SEE THAT REALLY OVER
THE WHOLE TIME WE'VE BEEN
FUNDING U01 CLINICAL TRIALS, AT
LEAST FOR THE PAST TEN YEARS,
THAT DEVICE TRIALS HAVE
PREDOMINATED, THE BLUE BARS YOU
SEE THERE.
AND, AGAIN, SHOWS TOTAL OF 13
TRIALS WITH TWO BEHAVIORAL,
EIGHT DEVICE, TWO DRUG TRIALS,
ONE NUTRITIONAL TRIAL.
SO THE FACT THAT THESE ARE
MOSTLY DEVICE RELATED CERTAINLY
ADDS TO THE RISK AND
COMPLEXITIES.
NEXT SLIDE.
THIS IS THE MAKEUP OF OUR
CLINICAL TRIALS OFFICE.
WE HAVE TWO FULL-TIME MEDICAL
OFFICERS, DR. TRINEDLY AND
JABARI, PRIMARY POINTS OF
CONTACT FOR MOST CLINICAL
TRIAL-RELATED QUESTIONS.
AND THEY ALSO HAVE A VARIETY OF
FUNCTIONS THAT I THINK I'LL SHOW
MORE IN THE NEXT SLIDE.
WE HAVE A CLINICAL TRIALS
OFFICER, DR. MCNAMARA, AND SHE'S
THE PRIMARY CONTRACT OFFICER FOR
NIDCD CLINICAL TRIALS, SHE ALSO
PROVIDES EXPERTISE IN HUMAN
SUBJECTS, INFORMED CONSENT,
CONFLICTS OF INTEREST.
CLINICAL TRIAL STATISTICIAN
PROVIDES STATISTICAL EXPERTISE,
HE'S INVOLVED IN THE DEVELOPMENT
OF CLINICAL TRIAL PROTOCOLS,
STATISTICAL ANALYSIS PLANS, AND
NIDCD STATISTICAL GUIDANCE. ANDA
SPECIAL VOLUNTEER CONTRIBUTES A
TREMENDOUS AMOUNT AS A MEDICAL
CENTER, VOLUNTEER, DID WORK FOR
NIDCD AND FOR NICHD OR CHILD
HEALTH AND HUMAN DEVELOPMENT
BEFORE THAT AND IS INVOLVED IN
SPECIAL PROJECTS AND PROVIDES
CONSULTATIONS TO US AND PROVIDES
A LOT OF SUPPORT.
WE HAVE TWO CONTRACTS, ONE IS A
CONTRACT RESEARCH ORGANIZATION
THAT PROVIDES FUNCTION ON THE
LEFT FOR COORDINATION AND
OPERATIONS, AND THE SECOND IS
THE DATA SAFETY MONITORING BOARD
SUPPORT CONTRACT, WHICH HELPS TO
PROVIDE ADMINISTRATIVE SUPPORT
FOR OUR DSMB.
NOT EVERY U01 HAS THEIR OWN,
SOME HAVE THEIR OWN, OVERSEEING
FHIR CLINICAL TRIALS OFFICE.
NEXT SLIDE.
THESE ARE THE ACTIVITIES OF OUR
CLINICAL TRIALS OFFICE.
THEY PROVIDE A TREMENDOUS AMOUNT
OF GUIDANCE, CONSULTATION,
EXTRAMURAL INVESTIGATORS AND
STAFF, IN A VARIETY OF FUNCTIONS
SHOWN HERE.
WE ALSO MANAGE OUR PORTFOLIO,
INCLUDING OPERATIONS AND
CONTRACTS AND PROVIDE EXPERTISE
AND OVERSIGHT FOR HIGH RISK U01
CLINICAL TRIALS, SO THEY ARE A
VERY BUSY GROUP.
AND THE NEXT SLIDE.
HOW CAN CLINICAL TRIALS ADVANCE
SAFE AND BENEFICIAL RESEARCH AND
INTERVENTIONS INTO PRACTICE?
THAT'S WHAT WE WANT TO KNOW,
WHAT ARE WE DOING WELL, WHAT CAN
WE DO BETTER, WHAT ARE THE NEEDS
OF OUR RESEARCH COMMUNITY WE CAN
FULFILL.
AND SO I WILL LEAVE THAT AT
THAT, AND WE'RE VERY MUCH
LOOKING FORWARD TO AND
APPRECIATE THE WORK OF THIS
WORKING GROUP.
I'LL ASK NOW IF ANY MEMBERS OF
OUR COUNCIL HAVE AN INTEREST IN
WORKING ON THIS, PLEASE DO LET
ME KNOW, I WOULD VERY MUCH
WELCOME YOUR INPUT AND YOUR
PARTICIPATION.
AND THE LAST SLIDE SHOWS OUR
AGENDA.
SHORTLY I WILL TURN THIS OVER TO
MR. ERIC WILLIAMS, WHO WAS OUR
BUDGET OFFICER FOR THE BUDGET
REPORT.
WE WILL THEN HEAR FROM DR. BECKY
MILLER, REPORT OF THE DIVISION
OF EXTRAMURAL ACTIVITIES.
WE HAVE TWO NEW COUNCIL MEMBER
PRESENTATIONS, FROM DOCTORS
NANCY YOUNG AND SWATHI KIRAN AND
REMARKS FROM A REAR TIRING
MEMBER.
NEXT SLIDE.
ERIC, WELCOME.
>> I'M GOING TO WAIT UNTIL I CAN
SEE IT POP UP.
>> ONE SECOND.
>> CAN YOU SEE THE SCREEN IN.
>> I CAN, THANK YOU.
>> I DID MAKE UPDATES.
WE'RE GETTING CONSTANT UPDATES
FROM TH ADMINISTRATION, FROM
INTERNAL NIH ON DIFFERENT
TOPICS, SO WE HAVE TO PRESENT
THE LAST PIECE OF INFORMATION
THAT WAS PRESENTED TO CONGRESS,
AND WITH CONTINUING RESOLUTION
THAT STARTED THIS YEAR, AND
CHANGES IN GUIDANCE AND WHAT
NOT, THERE HASN'T BEEN AN
UPDATED MECHANISM TABLE OR
OPERATING PLAN TRANSMITTED TO
CONGRESS.
I'LL SPEAK TO THIS ONE YEAR.
THIS IS HOW WE ENDED 2024.
I WANT TO TALK TO THE CHANGES
RHEE WE'RE MAKING IN 2025,
WAITING FOR GUIDANCE IN 2026,
AND WE'LL HAVE TO MAKE SOME
CHANGES TO OUR 2025 OUTCOMES.
AS YOU CAN SEE IN 2024,
NON-COMPETING NUMBER WAS LOW TO
WHAT WE NORMALLY HAVE, UP AROUND
271, 272 MILLION.
WE'RE LOOKING TO INCREASE OUR
NUMBERS THIS YEAR TO GET BACK UP
TO THERE.
BASED ON EXECUTIVE ORDERS,
ADMINISTRATIVE SUPPLEMENTS HAVE
BEEN PRETTY MUCH GUTTED.
WE MIGHT SPEND A MILLION DOLLARS
ON THAT, SO THOSE FUNDS WILL GO
DOWN COMPARED TO 2024.
SIMILARLY COMPETING DOLLARS WILL
GO DOWN AS WELL.
WE HAD ANOTHER FLAT BUDGET, AND
HOLES TO FILL, INCLUDING
INCREASES TO NON-COMPETING BASE.
WOULDN'T SAY THERE'S MUCH OF A
CHANGE TO RESEARCH CENTERS,
STAYING PRETTY MUCH FLAT, AS
WELL AS CAREERS.
THE OTHER RESEARCH CATEGORY WE
WERE SEEING A LITTLE BIT OF
INCREASE BUT BASED ON SOME
EXECUTIVE ORDERS WHERE THE
R25s ARE, THE DIVERSITY
R25s, THAT NUMBER PROBABLY AT
THIS POINT IS GOING TO GO DOWN A
LITTLE BIT.
>> I'M GOING TO INTERRUPT.
BROOKE, CAN YOU ZOOM IN OR GO TO
THE PRESENTER VIEW SO WE CAN SEE
IT LARGER?
>> LET ME SEE.
ONE SECOND.
THANK YOU.
>> SO IF WE COULD PAN DOWN ON
THE TABLE.
INSTITUTIONAL TRAINING, A
DECREASE, NO CHANGE TO THE
NUMBER OF PEOPLE WE'LL BE
SERVICING THROUGH INSTITUTIONAL
TRAINING, JUST SOME SCALEDOWNS
WE'LL BE CLEANING UP, WE KEPT A
LARGE BALANCE THERE TO BE USED
TO TAKE CARE OF OTHER PRIORITIES
THIS YEAR.
AND THE R&D CONTRACT SECTION,
ORIGINALLY WE WERE THINKING IT
WAS GOING TO GO DOWN, BASED ON
THE WAY WE SEE SOME OF THE
THINGS HAPPENING NEXT YEAR,
WE'RE ACTUALLY GOING TO SPEND
PROBABLY A LITTLE BIT MORE SO WE
CAN PAY DOWN OUR R&D CONTRACTS
AND PREPAY THEM FOR FY 26 AND FY
27.
INTRAMURAL RESEARCH, BOTH WILL
SEE BUMP UPS BASED ON SOME
SALARY INCREASES, SOME OTHER
FACTORS, BUT AS MUCH AS WE
THOUGHT IT'S GOING TO BE
TEMPERED DOWN BASED ON, YOU
KNOW, SOME OF THE HR ACTIONS
THAT HAPPENED SINCE THE
ADMINISTRATION CAME IN, SO
PROBABLY A LITTLE BIT OF
INCREASE, A CHALLENGE SPENDING
SOME MONEY BECAUSE SOME
CONTRACTING STAFF HAVE BEEN LET
GO AND WE'RE HAVING TROUBLE
GETTING SOME CONTRACTING ACTIONS
TAKING PLACE.
YEAH, I DON'T HAVE MORE I'M
ALLOWED TO GIVE YOU NOW BUT I
THINK WE HAVE ABOUT THREE OR
FOUR SCENARIOS AND I'M HAPPY TO
ADDRESS THOSE IF ANYONE HAS
QUESTIONS.
GOING TO THE NEXT SLIDE PLEASE.
LOOKING AT WHAT WE DID WITH OUR
MONEY AS FAR AS OUR MISSION
AREAS, SO THESE PIECHARTS SHOW
COMPARISON BETWEEN 2023 AND
2024.
THE REAL DIFFERENCE WE DON'T
MOVE SIGNIFICANTLY FROM ONE YEAR
TO THE NEXT YEAR, BUT BETWEEN 23
AND 24 LANGUAGE WENT DOWN A
LITTLE BIT AND SMELL WENT UP,
EVERYTHING ELSE IS PROBABLY
WITHIN A LITTLE MARGIN OF ONE OR
TWO GRAND GOING TO ONE OR THE
OTHER.
NEXT SLIDE PLEASE.
JUST LOOKING AT OUR SUCCESS
RATE, SO NIDCD IS VERY -- HAS A
HIGHER SUCCESS RATE THAN THE
REST OF NIH WHEN IT COMES TO
RESEARCH PROJECT GRANTS
TYPICALLY YEAR OVER YEAR AWARD A
FIVE PERCENTAGE MORE OF OUR
APPLICATIONS THAN THE REST OF
NIH, AND WHEN IT COMES TO OUR
FELLOWSHIPS SUCH AS NEXT TABLE
DOWN, ABOUT 10% BETTER SUCCESS
RATE THAN THE REST OF NIH.
SO NEXT TABLE, SORRY, NEXT
SLIDE, JUST LOOKING AT OUR
BUDGET WE'VE HAD THREE FLAT
BUDGETS BACK TO BACK TO BACK.
THIS IS A HUGE CHALLENGE FOR US
TO UNDERTAKE.
WE DO NOT KNOW REALLY WHAT FY 26
BUDGET IS GOING TO LOOK LIKE.
THE PRESIDENT'S BUDGET, YOU
KNOW, THIS IS SIMILAR TO THE
PRESIDENT'S BUDGET WE RECEIVED
IN THE FIRST TRUMP
ADMINISTRATION, WHERE THERE WERE
CUTS AND OBAMA ADMINISTRATION
WHERE THERE WAS SIGNIFICANT
GROWTH, AND THESE ARE -- TEND TO
BE POSTURING DOCUMENTS.
THIS YEAR REFLECTS 40% CUT,
THERE'S SOME ELEMENTS IN THERE
THAT THEY ASSUME IS GOING TO
NECESSITATE 40% CUT INCLUDING
15% INDIRECT COST CAP, SALARY
CAPS, RESTRUCTURING AND WHAT
NOT.
WE'RE WAITING TO SEE WHAT THE
HOUSE AND SENATE MARKS ARE
BECAUSE OUR FINAL BUDGE SET
TYPICALLY MORE IN ALIGNMENT WITH
WHAT THOSE MARKS ARE, THAN THE
PRESIDENT'S BUDGET.
SO OUR STRATEGY AT THIS POINT
WITH THE BUDGE SET JUST TO BE
PATIENT.
WE NEED MORE DATA POINTS SO WE
KNOW HOW WE'RE GOING TO END UP
THIS YEAR.
HPPs AND END OF YEAR SPENDING
WE HAVE TO BE STRATEGIC ABOUT
HOW WE DO IT TO SET OURSELVES UP
BEST FOR NEXT YEAR.
THERE ARE CUTS, WE'RE GOING TO
HAVE DO THINGS TO PREPARE US FOR
CUTS NEXT YEAR SO WE CAN HAVE A
MORE ROBUST COMPETING PORTFOLIO,
AND SO I THINK IT'S GOING TO BE
A LITTLE BIT OF WAITING GAME ON
THESE NEGOTIATIONS AND CAPITAL
HILL TAKE PLACE SO WE NEED TO BE
FLEXIBLE.
WE WILL GET PAYLINE OUT.
WE'LL GET CERTAIN PAY PLANS OUT,
BUT AS FAR AS LIKE THE BULK OF
MONEY TOWARD THE END OF THE YEAR
RESOLUTION OF SOME OF THESE
COURT ORDERS, WITHHOLDING FUND,
CERTAIN INSTITUTES AND
UNIVERSITIES, WE JUST HAVE TO
SEE THOSE PLAY OUT BEFORE WE CAN
REALLY MAKE A DETERMINATION ON
HOW WE SPEND OUT THE REST OF THE
YEAR.
WITH THAT, I'M OPEN FOR ANY
QUESTIONS ANYONE MIGHT HAVE.
I SEE ONE.
>> I WONDER WILL THIS SLIDE DECK
BE AVAILABLE?
SOME OF THEM WENT BY VERY FAST
OR WEREN'T VISIBLE ON THE
SCREEN.
>> WE CAN POST THAT IN ECB FOR
YOU, YEAH.
>> THANK YOU.
>> ERIC'S CAREFUL TO PRESENT
ONLY PUBLICLY AVAILABLE
INFORMATION.
ANY OTHER QUESTIONS?
ERIC, THANK YOU VERY MUCH.
THANK YOU FOR ALL OF YOUR WORK
ON THIS.
IT'S A VERY HEAVY LIFT TO
BALANCE ALL OF THESE COMPETING
PRIORITIES AND UNCERTAINTIES SO
WE APPRECIATE IT.
>> THANK YOU.
>> ALL RIGHT.
NEXT WE HAVE DR. MILLER WHO IS
GOING TO GIVE THE TRIENNIAL
INCLUSION REPORT.
>> OKAY.
SO, I'LL GIVE THE REPORT AS PART
OF THE REPORT OF THE DIVISION OF
EXTRAMURAL ACTIVITIES.
SO, FIRST, THE INCLUSION POLICY
IS DESIGNED TO GUARANTEE
CLINICAL TRIALS EXAMINE EFFECTS
OF SEX AND RACIAL AND ETHNIC
GROUPS, AND SO TRIENNIAL
INCLUSION REPORT DESCRIBES
COMPLIANCE, AND 21ST CENTURY
CURES ACT TRAININGED THAT TO
TRI'EM REPORTING, OFFICE OF
MANAGEMENT AND BUDGET SETS
MINIMUM STANDARDS FOR
MAINTAINING, COLLECTING,
PRESENTING DATA.
AND THEN POSTED IN ECB PRIOR TO
THE MEETING TO REVIEW.
THE OUTLINE OF WHAT THE REPORT
DID COVER WAS THAT THERE WAS
MISSION STATEMENT, INSTITUTE
PORTFOLIO, BACKGROUND,
STRATEGIES FOR COMPLIANCE AND
ANALYSIS AND INTERPRETATION OF
THE DATA.
THIS INCLUSION TABLE AND REPORTS
WERE PREPARED AND GENERATED BY
NIH OFFICE OF EXTRAMURAL
RESEARCH.
THIS TABLE 2.1 IS TOTAL
INCLUSION REPORT FOR NIH DEFINED
CLINICAL RESEARCH, EACH
INCLUSION ENROLLMENT REPORT,
IER, CONTAINS THE INCLUSION DATA
FOR HUMAN SUBJECT RESEARCH
COMPONENT OF A PROJECT,
THEREFORE PROJECTS MAY HAVE
MULTIPLE IERs.
AND THE IERs WITHOUT
ENROLLMENT, INVESTIGATORS
PLANNED TO RECRUIT HUMAN
SUBJECTS THAT HAVE NOT ENROLLED.
THIS TABLE IS THE ENROLLMENT
DETAILS FOR ALL OF NIH CLINICAL
TRIALS SUPPORTED BY NIDCD,
BROKEN BY SEX, RACE, AND
ETHNICITY.
I KNOW THERE'S A LOT OF
INFORMATION.
I'LL GO THROUGH IT IN MORE
DETAIL IN THE NEXT SEVERAL
SLIDES.
THIS IS THE SEX OF THE
PARTICIPANTS IN ALL OF OUR
NIDCD-SUPPORTED CLINICAL
RESEARCH.
THE DATA ARE BASED ON
SELF-REPORTING BY THE HUMAN
SUBJECTS, SOME CHOOSE NOT TO
DISCLOSE RACE, ETHNICITY, OR
SEX.
THIS RESULTS IN UNKNOWN OR NOT
REPORTED DATA.
HERE YOU CAN SEE ROUGHLY EQUAL
NUMBERS OF PERCENTAGES OF MALE
AND FEMALE PARTICIPANTS ENROLLED
IN CLINICAL RESEARCH.
THIS CHART SHOWS THE RACIAL
MAKEUP OF PARTICIPANTS IN ALL OF
OUR SUPPORTED RESEARCH, STEADY
OVER THE LAST THREE YEARS.
AND THEN ETHNICITY DEMONSTRATES
MAJORITY OF PARTICIPANTS ARE
IDENTIFIED AS NOT HISPANIC.
AND THEN THE NEXT AND FINAL
TABLE FROM THE REPORT THAT WE
PROVIDE IS THE HUMAN SUBJECTS
ENROLLMENT AND STAGE 3 CLINICAL
TRIALS, WE DID NOT HAVE ANY
STAGE 3 CLINICAL TRIALS, SO NO
DATA TO REPORT.
AND SUMMARY, JUST AS DEB ALLUDED
TO, FEWER CLINICAL TRIALS GOING
ON THAN WE USED TO.
AND SO OUR NUMBERS ARE
DEFINITELY DOWN FROM 2022
REPORT, THE LAST TIME WE
REPORTED ON THIS.
STAFF ARE DILIGENT IN MONITORING
ENROLLMENT PROJECTIONS AND THE
ACCRUAL PATTERNS OVER THE LIFE
OF THE GRANTS.
AND WHEN NECESSARY WE CONTACT
THE INVESTIGATORS TO CLARIFY OR
CORRECT ACCRUAL DATA.
THIS INCLUSION ENROLLMENT DATA
IS DONE BY THE RCDC, CATEGORIES
WILL BE AVAILABLE ON THE WEBSIE
AT A LATER DATE.
THAT'S IT FOR INCLUSION REPORT.
AND THEN I WANTED TO SHIFT AND
WE HAD ONE NO STAFF MEMBER JOIN
SINCE SEPTEMBER.
THAT'S MISS NATALIE LANIER, THE
GRANTS MANAGEMENT SPECIALIST, IN
OUR GRANTS MANAGEMENT BRANCH.
BRINGS A DECADE OF EXPERIENCE IN
GRANTS MANAGEMENT BEFORE COMING
WORKED THEY NATIONAL HUMAN
GENOME RESEARCH INSTITUTE AT
NIH.
AND HAS SEARCHED AS A SPONSORED
PROJECT ADMINISTRATOR AT GEORGE
WASHINGTON UNIVERSITY BEFORE
THAT.
SO WE'RE VERY TO HAVE HER ON
BOARD.
WE HAVE RETIREMENTS, GREAT
TIMING SHE CAME ON RIGHT BEFORE
FOLKS RETIRED.
AND THEN I COULDN'T END WITHOUT
RECOGNIZING THE AMAZING PEER
REVIEWED STAFF AT NIDCD.
SO AS MANY OF YOU HEARD PEER
REVIEW AT NIH IS BEING
CONSOLIDATED IN THE CENTER FOR
SCIENTIFIC REVIEW, ALL PEER
REVIEW WILL BE MANAGED, IN
MEETINGS MANAGED BY CSR.
OUR STAFF WILL MOVE TO CSR BY
THE END OF MAY, WHILE THE REVIEW
STAFF ARE TRANSITIONING, THEY
ARE STILL WITH US ON SHORT
DETAIL TO CSR, ALREADY HELPING
OUT WITH PEER REVIEW, AN MANY
MEETINGS WE HAD RUN OURSELVES
WILL CONTINUE TO BE RUN BY SOME
OF OUR STAFF FOR THE NEXT ROUND
AT LEAST AND THEN I THINK SOME
WILL CONTINUE TO BE WITHIN STUDY
SECTIONS THAT OUR SCIENTIFIC
REVIEW STAFF AS PART OF CSR WILL
BE FOCUSED IN OUR SCIENTIFIC
AREAS.
WHILE THE STAFF WILL BE SERVING
RESEARCH COMMUNITY WE WILL
CERTAINLY MISS THEM GREATLY,
WE'RE ALL VERY CLOSE AND THEIR
ABSENCE WILL LEAVE A HOLE IN OUR
INSTITUTE.
SO WE LOOK FORWARD TO CONTINUING
TO WORK WITH THEM AS A PARTNER
TO HELP US FUND THE BEST
SCIENCE.
PLEASE JOIN ME IN THANKING
TANIA, ANDRE A, SONIA, BOBBY AND
KATHY AND WISH THEM WELL AS THEY
MOVE TO CSR.
IT'S BEEN A BIG YEAR OF STAFFING
CHANGES, WITH SEVERAL
RETIREMENTS THAT REDUCED OUR
NUMBERS, BUT EVERYONE HAS BEEN
HELPING STEP UP WHEN THEY CAN
AND WHERE THEY CAN SO I THANK
EVERYONE FOR THEIR WORK TO HELP
US FUND THE BEST SCIENCE AND
ENSURING COMPLIANCE.
THAT'S MY REPORT FOR DEA.
>> THANK YOU, BECKY.
WE'LL MOVE NOW TO A PART OF THE
PROGRAM THAT I'M VERY EXCITED
ABOUT, AS I MENTIONED WE HAVE
TWO NEW COUNCIL MEMBER
PRESENTATIONS, AND I WILL
WELCOME FIRST DR. NANCY YOUNG.
>> THANK YOU.
I'M GOING TO SHARE MY SLIDES.
>> OKAY.
THERE WE GO.
ALL RIGHT.
SO, I'M A SURGEON, FELLOWSHIP
TRAINED IN NEUROONTOLOGY, LURIE
CHILDREN'S HOSPITAL OF CHICAGO,
FOUND THE COCHLEAR IMPLANT
PROGRAM, ONE OF THE LARGEST FOR
CHILDREN IN THE U.S.
I'VE HAD THE OPPORTUNITY TO
OBSERVE FIRST HAND MANY CHILDREN
WHOSE LANGUAGE AND LITERACY HAVE
BEEN TRANSFORMED BY COCHLEAR
IMPLANTATION.
DECADES OF RESEARCH HAVE
DEMONSTRATED CHILDREN WITH
CONGENITAL HEARING LOSS FOR WHOM
HEARING AIDS DO NOT PROVIDE
ADEQUATE ACCESS TO SPOKEN
LANGUAGE HAVE BETTER OUTCOMES
WHEN IMPLANTED EARLY.
HOWEVER, THERE IS SIGNIFICANT
VARIABILITY IN LANGUAGE EVEN FOR
CHILDREN IMPLANTED AT YOUNG AGE.
THIS GRAPH COMPARES HEARING
CHILDREN, GRAY BARS, TO YOUNG
IMPLANTED CHILDREN, YELLOW BARS.
VARIABILITY IS STRIKING.
FOR THIS REASON AT PRESENT WE'RE
UNABLE TO ACCURATELY PREDICT
LANGUAGE AFTER COCHLEAR
IMPLANTATION ON THE INDIVIDUAL
CHILD LEVEL USING TRADITIONAL
FACTORS OF AGE AT IMPLANTATION
AND RESIDUAL HEARING.
VARIABILITY IN OTHER WORDS
UNPREDICTABLE OUTCOMES IS WHY I
BECAME INTERESTED IN THE ROLE OF
THE BRAIN IN LANGUAGE
DEVELOPMENT.
WILL UNDERSTANDING
NEUROPLASTICITY IN CHILDREN WITH
HEARING LOSS HELP US UNDERSTAND
VARIABILITY AND IMPROVE
LANGUAGE?
SPEECH PERCEPTION INVOLVES
BOTTOM UP AND TOP DOWN
PROCESSING, CONSTRUCTION OF
PERCEPTIONS, FROM SENSORY
INTEGRATION, AND BENEFITS FROM
SENSORY INFORMATION AND BENEFITS
FROM IMPROVEMENT IN THE ACOUSTIC
SIGNAL.
TOP-DOWN PROCESSING USES PRIOR
KNOWLEDGE AND EXPERIENCE TO
INTERPRET INCOMING INFORMATION,
OVER TIME THE BRAIN CAN MAKE
SENSE OF ACOUSTIC SIGNALS FROM
IMPLANT AND UNDERSTAND SPOKEN
LANGUAGE.
OUR RESEARCH GROUP FOCUSES ON
USING BRAIN ANATOMY IN 3D, HIGH
RESOLUTION MRI TO PREDICT
LANGUAGE AFTER IMPLANTATION.
THE VOLUME, TISSUE DENSITY AND
SURFACE AREA CAN BE PLEASURED.
>> NANCY --
>> THANK YOU.
I DIDN'T WANT TO SHUT DOWN ON
YOU.
IT'S ALL GOOD.
I APPRECIATE YOUR HELP.
SO THE FIRST STEP IS COMPARISON
OF BRAINS WITH NORMAL HEARING
AND COCHLEAR IMPLANT CANDIDATES
TO DETERMINE REGIONS AFFECTED OR
UNAFFECTED BY HEARING LOSS.
SECOND TO DETERMINE WHETHER
AFFECTED OR UNAFFECTED REGIONS
BEST PREDICT OUTCOMES BY
BUILDING MACHINE LEARNING
ENABLED PREDICTION MODELS.
INITIAL PILOT STUDY REVEALED THE
UNAFFECTED REGIONS BEST
PREDICTED WHICH CHILDREN WOULD
BE HIGH, VERSUS LOW, LANGUAGE
IMPROVERS IN THE SHORT TERM.
THE ACCURACY OF MACHINE LEARNING
MODEL PREDICTIONS USING BRAIN
STRUCTURE WAS SIGNIFICANTLY
BETTER THAN MACHINE LEARNING
PREDICTION USING AGE AT IMPLANT
AND RESIDUAL HEARING.
WE HAVE AN NIH-FUNDED
MULTI-CENTER STUDY TO BUILD
MACHINE LEARNING MODELS TO
EVALUATE LONG-TERM OUTCOMES IN
ENGLISH AND SPANISH LEARNING
CHILDREN AND TREATMENT ARM
EXAMINING IF EFFECTIVE
BEHAVIORAL INTERVENTION CAN
IMPROVE OUTCOMES OF CHILDREN
PREDICTED TO BE LOW LANGUAGE
IMPROVERS.
RECENTLY, WE EXAMINED IMPACT OF
DURATION OF HEARING AID USE
PRIOR TO IMPLANTATION AND FOUND
EARLY HEARING AID FITTING
PRESERVES STRUCTURE OF AUDITORY
CORTEX, BUT THE EFFECT IS
TEMPORARY AND IS GREATER FOR
THOSE WITH MORE PROFOUND LOSS.
STRUCTURAL PRESERVATION MAY
EXPLAIN PRIOR RESEARCH THAT
FOUND THAT EARLIER FITTING OF
HEARING AIDS BEFORE IMPLANTATION
RESULTED IN BETTER SPEECH
PERCEPTION.
NEURAL PRESERVATION HIGHLIGHTS
CLINICAL IMPORTANCE OF BOTH
EARLY FITTING OF HEARING AIDS
AND EARLY IMPLANTATION.
ACCURATE BRAIN BASED PREDICTION
MAY THE FIRST STEP TOWARD A NEW
STANDARD OF CUSTOMIZED CARE,
PREDICTION HAS THE POTENTIAL TO
IMPROVE COUNSELING, PROVIDE A
FRAMEWORK TO DEVELOP THERAPIES
SPECIFIC TO BRAIN TYPE AND
REDUCE COST BY DETERMINING
EFFECTING DOSE AND TYPE OF
BEHAVIORAL THERAPY.
NEURAL PREDICTION HAS POTENTIAL
TO IMPROVE UNDERSTANDING OF
NEURAL MECHANISMS UNDERLYING
SPOKEN LANGUAGE DEVELOPMENT.
>> THANK YOU.
THAT WAS GREAT.
ANY QUESTIONS BY MEMBERS OF
COUNCIL?
REALLY INTERESTING AND
COMPELLING WORK.
THANK YOU SO MUCH.
>> THANK YOU.
>> ALL RIGHT.
SO, NEXT WE'LL HAVE A
PRESENTATION BY DR. SWATHI
KIRAN.
>> I'M TRYING TO SEE IF I CAN
SHARE MY SCREEN..
YOU CAN SEE MY SCREEN NOW?
>> YES, NOW.
>> OKAY.
SO GOOD AFTERNOON.
I'M REALLY PLEASED TO HAVE THE
CHANCE TO SHARE THE WORK THAT
WE'RE DOING AT BOSTON
UNIVERSITY.
I HAVE BEEN FORTUNATE TO HAVE
BEEN FUNDED BY NIH THROUGH MY
CAREER AND ALSO WANT TO POINT
OUT I AM THE CO-FOUNDER OF THE
DIGITAL HEALTH COMPANY, CONSTANT
THERAPY, THAT I'LL BE TALKING
ABOUT TODAY.
WHAT KIND OF CENTER IS FOCUSED
ON REHABILITATION, RECOVERY, FOR
NEUROLOGICAL DISESPECIALLY
SPOKE, ON PRECISION
REHABILITATION, OUR WORK AND
VISION OF THE FUTURE WHERE BRAIN
INJURY SURVIVAL WILL GO TO LAB
OR CLINIC AND GET A COMPLETE
NEURAL LANGUAGE AND SOCIAL
FUNCTIONAL PROFILE WORKUP DONE
AND THIS INFORMATION WILL BE
USED TO PREDICT INDIVIDUALIZED
RECOVERY PROFILES AND THEN BASED
ON THAT INFORMATION WE CAN
PROVIDE RECOMMENDATIONS ON
WHETHER THAT PERSON SHOULD
RECEIVE INTENSIVE INDIVIDUAL
THERAPY, OR GO TO A SOCIAL GROUP
THERAPY, OR RECEIVE VOCATIONAL
TRAINING.
WE'RE NOT THERE YET.
OUR WORK FOCUSED ON EXAMINING
BRAIN STRUCTURES AND FUNCTIONS
THAT DETERMINE THE DEGREE TO
WHICH BRAIN DAMAGE WILL RECOVER.
WORK IS FOCUSED ON SEVERAL YEARS
OF EXAMINING NATURE OF LANGUAGE
AND COGNITIVE IMPAIRMENT AND HOW
THAT EFFECTS ABILITY TO
SUCCESSFULLY FUNCTION IN THE
ENVIRONMENT.
FINALLY QUITE A FEW YEARS
DEVELOPING EFFECTIVE TREATMENTS
FOR THESE DEFICITS.
MORE RECENTLY WE'VE BEEN ABLE TO
INTEGRATE THESE
MULTI-DIMENSIONAL FACTORS TO
DEVELOP MACHINE LEARNING AND
COMPUTATIONAL ALGORITHMS TO
PREDICT WHICH OF THESE FACTORS
ARE IMPORTANT IN PREDICTING
RECOVERY AND HOW THESE PIECES OF
INFORMATION CAN THEN ENABLE US
TO BETTER PREDICT PROGNOSIS AND
OUTCOME.
I'M GOING TO GIVE A FEW
EXAMPLES.
FIRST EXAMPLE, I'D LIKE TO TELL
YOU ABOUT HOW WE'RE BUILDING
DIGITAL TWINS FOR PEOPLE WHO
SPEAK MULTIPLE LANGUAGES,
BROADER IMPLICATIONS FOR HOW THE
BRAIN PROCESSES INFORMATION.
SO HERE'S THIS COMPUTATIONAL
MODEL OF HOW A BRAIN CAN THINK
ABOUT WORDS AND MEANINGS.
AND IN THIS CASE TRYING TO
SIMULATE TWO LANGUAGES.
I'LL SHOW YOU SIMULATION,
HOPEFULLY CAN YOU SEE IT.
ON THE LEFT-HAND SIDE COMPUTER
MODEL IS LEARNING WORDS AND
MEANINGS.
ON THE RIGHT SIDE LEARNING
PHONETIC REPRESENTATIONS IN
ENGLISH AND SPANISH.
THIS INFORMATION IS RECEIVING
MORE INPUT IN SPANISH THAN
ENGLISH, GOING TO BECOME A
BILINGUAL, MORE PROFICIENT IN
ONE LANGUAGE.
HOPEFULLY YOU CAN SEE THE
REPRESENTATION.
WE CAN TAILOR DIGITAL TWIN FOR
ANY PERSON WHO IS BILINGUAL AND
VARY THE LEVEL OF PROFICIENCY
AND EXPOSURE.
WE'VE DONE THIS IN ENGLISH AND
SPANISH AND MANDARIN.
ONCE WE HAVE THESE MODELS,
ESSENTIALLY LIKE HEALTHY
BILINGUALS, WE CAN INTRODUCE A
LESION INTO THE MODEL AND MAKE
THEM BEHAVE AS IF THEY HAD
BILINGUAL APHASIA BY TWEAKING
AMOUNT OF DAMAGE.
WE CAN RETRAIN THESE MODELS
SIMILAR TO HOW THEY LEARN
LANGUAGE AND PREDICT HOW MUCH
RECOVERY THE MODEL IS GOING TO
SHOW AND THEN MATCH TO ACTUAL
INDIVIDUAL PEOPLE.
WE JUST COMPLETED A RANDOMIZED
CONTROLLED TRIAL TO SEE IF MODEL
CAN PREDICT INDIVIDUAL RECOVERY
PATTERNS AND TURNS OUT IT CAN DO
A PRETTY GOOD JOB OF DOING THAT.
AND LASTLY, USING THE SAME
STARTING POINT OF THE
COMPUTATIONAL MODEL WE CAN
CREATE DIGITAL TWINS TO SIMULATE
DEMENTIA BUT INSTEAD OF SHOWING
RECOVERY WE CAN SIMULATE DECLINE
BY INCREASING GRADUALLY THE SIZE
OF THESE BRAIN LESIONS.
ANOTHER LINE OF WORK THAT WE'RE
DOING IS TRYING TO USE
INFORMATION ABOUT THE BRAIN AND
ITS INTEGRITY AFTER ITS ROLE TO
PREDICT RECOVERY.
IN A PAPER PUBLISHED A FEW YEARS
AGO WE LOOKED AT HOW AND TO WHAT
EXTENT STRUCTURAL AND FUNCTIONAL
INTEGRITY OF THE BRAIN THROUGH
STROKE COULD PREDICT BENEFIT OF
THERAPY.
WE FOUND SIMPLE SUPPORT VECTOR
MACHINE MODELS DID A GOOD JOB
CLASSIFYING WHETHER A PATIENT
WAS GOING TO RECOVER FROM
APHASIA THERAPY OR NOT,
STRUCTURE AND FUNCTION WERE THE
MAIN PREDICTORS.
THIS WORK EVOLVED INTO MORE
EFFICIENT DEEP LEARNING MODELS,
THAT CAN BE AUGMENTED WITH
SYNTHETIC BRAIN LESIONS TO BE
ABLE TO PREDICT SEVERITY OF
APHASIA AND HOW SOMEBODY GOING
TO RECOVER IN THE THERAPY AS
WELL IN THE FUTURE.
LASTLY WE'RE ALSO TRYING TO
BUILD PERSONALIZED THERAPY
TRANSLATORS, USING LARGE DATASET
FROM DIGITAL COMPANY WHICH I
HELPED CO-FOUND, WHICH HAS ABOUT
3.5 MILLION THERAPY SESSIONS
FROM ABOUT 18,000 APP USERS.
WE'VE DEVELOPED MACHINE LEARNING
ALGORITHM THAT CAN ESTIMATE
PROBABILITY OF IMPROVEMENT GOING
FROM ONE FUNCTIONAL LANDMARK IN
A GIVEN DOMAIN, WHILE ACCOUNTING
FOR THINGS LIKE AGE, ETIOLOGY,
STARTING PERFORMANCE, FREQUENCY
AND DURATION, SO WHAT YOU SEE IS
THE RESULT OF THE MACHINE
LEARNING REGRESSION MODELS THAT
PREDICT OUTCOMES.
I WANT TO SHOW A DEMO THAT SHOWS
USER INTERFACE THAT PEOPLE CAN
ENTER INFORMATION HERE, AND AS
IT CALLS BACK THE MACHINE
LEARNING MODEL, SO HERE YOU CAN
SEE A PERSON GOING TO THE
WEBSITE, ENTERED THEIR AGE, HOW
LONG THEY HAVE HAD THEIR STROKE,
AND WHICH DOMAIN THEY WANT TO
WORK O ON.
IT'S ASKING SUBJECTIVE
QUESTIONS, SCROLL FORWARD, AND
IT ASKS SPECIFIC QUESTIONS HOW
THEY WOULD COMPUTE THE MATH IF
THEY WERE ASKED TO.
IN THIS CASE IT'S CALCULATING
MONEY.
AND THEN ASKS THEM TO TELL TIME,
I'M GOING TO SCROLL PAST THAT.
IT ASKS MORE SOPHISTICATED MATH.
THIS PREPARES PREDICTIONS BASED
ON THE ALGORITHM AND TELLS THE
PATIENT THEIR STARTING POINT IS
THIS LANDMARK, AND THEY HAVE TO
MOVE TO THE NEXT LANDMARK.
NOW IT ASKS THE PATIENT HOW LONG
DO YOU WANT TO PRACTICE, THE
PATIENT PICKS FIVE YEARS, I'M
SORRY, FIVE DAYS A WEEK, FIVE
WEEKS, MODEL SAYS THAT THAT
THERAPY PRACTICE IS GOING TO
ACTUALLY HIGHLY LIKELY RESULT IN
PRODUCTIVE OUTCOME.
THESE ARE THE INDIVIDUALIZED
MODELS WE'RE TRYING TO PREDICT.
THIS WORK IS NEW AND WE'RE
TRYING TO OPTIMIZE BUT THIS IS
THE KIND OF PRECISION
REHABILITATION WE'RE GOING FOR.
THANK YOU VERY MUCH.
>> THANK YOU VERY MUCH.
THAT WAS FASCINATING.
ANY QUESTIONS OR DISCUSSION FROM
COUNCIL ON EITHER PRESENTATION?
THANK YOU SO MUCH FOR DOING
THIS.
IT'S JUST REALLY FUN TO HEAR IN
MORE DEPTH WHAT MEMBERS OF THE
COUNCIL DO IN THEIR SCIENTIFIC
LIVES.
IT MAKES IT ALL A LITTLE BIT
EASIER TO APPRECIATE WHAT EVERY
MEMBER OF OUR COUNCIL DOES.
THANK YOU VERY MUCH TO BOTH OF
YOU FOR DOING THAT.
SO, NOW I THINK WE'RE ALMOST TO
THE END, AMAZINGLY, SHORT
MEETING TODAY.
I WANTED TO END BY THANKING OUR
RETIRING MEMBER OF COUNCIL, MISS
VICKIE DEAL WILLIAMS.
THANK YOU SO MUCH, VICKIE, FOR
YOUR CONTRIBUTIONS TO COUNCIL.
YOU'VE BEEN SO THOUGHTFUL AND
REALLY INFLUENTIAL, I THINK, IN
MANY OF OUR DISCUSSIONS.
AND WE TRULY APPRECIATE IT.
I WANTED TO SEE IF YOU WANTED TO
SAY A QUICK GOOD-BYE, ANY
PARTING WORDS THAT YOU HAVE, WE
WILL CERTAINLY MISS YOU AND YOUR
CONTRIBUTIONS.
>> NOT EASY WITH ALL THESE
BUTTONS.
THANK YOU, DEB.
IT HAS TRULY BEEN AN HONOR TO
SERVE ON THIS COUNCIL, AND IN
THIS ROLE, AND QUITE A
RESPONSIBILITY FOR A
NON-RESEARCHER, EVEN AS A
SPEECH-LANGUAGE PATHOLOGIST,
I'VE LEARNED A GREAT DEAL DURING
THE FOUR YEARS THAT I'VE BEEN IN
THIS ROLE.
DURING THAT TIME MY FOCUS HAS
BEEN ON TRYING TO GET US TO
THINK ABOUT HOW TO CHANGE THE
WAY WE LOOK AT THE FACT THAT
WE'VE BEEN MENTORING AND
DEVELOPING SPECIFIC PEOPLE INTO
CONFORMING INTO OUR SYSTEMS AND
RECOGNIZING THAT OUR SYSTEMS AND
PROCESSES HAVEN'T NECESSARILY
EVOLVED WITH THE RESEARCHERS AND
THE RESEARCH THAT THESE
INDIVIDUALS HAVE BEEN DOING OR
LOOKING TO CONDUCT, AND I'M
GRATEFUL THAT THOSE SENTIMENTS
HAVE BEEN HEARD AND I THINK
HEEDED.
I THINK A LOT OF WORK HAS BEEN
DONE, A LOT OF CHANGES HAVE BEEN
MADE.
AND I THINK THAT A LOT OF THE
RESEARCH AND THE RESEARCHERS AND
THE RESEARCH THAT THOSE
INDIVIDUALS WERE LOOKING TO
CONDUCT WAS IN THE PIPELINE AND
MOVING FORWARD.
AND NOW I HEAR, I UNDERSTAND
THAT PRIORITIES ARE CHANGING,
AND THAT THOSE ARE NOT
NECESSARILY ALIGNED WITH THE
CURRENT PRIORITIES, BUT THAT
BRINGS ME TO MY SECOND POINT,
AND I GUESS MY HOPE FOR WHERE
THE COUNCIL GOES, AS I LEAVE
THIS POST.
AND ALL OF THE PEOPLE IN THIS
COUNTRY MERIT THE SERVICES THAT
THIS SCIENCE THAT WE SUPPORT
PROVIDES.
AND THOSE PEOPLE AND THAT
RESEARCH HAS CHANGED OVER TIME.
IT WILL CONTINUE TO CHANGE OVER
TIME.
AND OVER TIME, RECOGNITION THAT
THERE ARE A LOT OF UNANSWERED
QUESTIONS RELATED TO THOSE
POPULATIONS AND THE NUMBER OF
INITIATIVES THAT HAVE BEEN PUT
IN PLACE TO CONDUCT RESEARCH AND
ANSWER QUESTIONS HAS OCCURRED.
BUT THOSE QUESTIONS NOW ARE
GOING TO REMAIN UNANSWERED.
ALL THOSE PEOPLE STILL MERIT
THAT SERVICE THAT WILL ONLY GET
ANSWERED IF WE CONTINUE THAT
RESEARCH.
THAT RESEARCH IS NEEDED TO GUIDE
THAT SERVICE.
THE ONLY WAY THAT NIDCD AND THE
BROADER NIH CAN ANSWER THOSE
QUESTIONS IS TO CONTINUE TO
EVOLVE AND TO LOOK DIFFERENTLY
AT HOW TO ANSWER THOSE
QUESTIONS.
NOT TO NOT ANSWER THEM AT ALL.
I THINK THAT'S WHAT I WANT TO
LEAVE EVERYBODY WITH.
THE ISSUE IS NOT SAYING THINGS
JUST DON'T ALIGN AND WE CAN'T DO
THEM.
IT'S HOW DO WE DO THEM, HOW DO
WE DO THEM DIFFERENTLY, WHAT ARE
THE CRITERIA, HOW DO WE DEFINE
THE CRITERIA SO THAT EVERYBODY
GETS A PIECE OF THIS PIE, SO
THAT THE RESEARCH PIE GETS
DIVIDED UP DIFFERENTLY SO THAT
EVERYBODY HAS ACCESS.
AND I THINK THAT, YOU KNOW, THE
REALITY IS WE HAVE TO LOOK
DIFFERENTLY AT THE POPULATIONS
THAT TYPICALLY AND TRADITIONALLY
AND HISTORICALLY HAVE BEEN
STUDIED SO THAT WE'RE STUDYING
EVERYONE.
BUT THANK YOU FOR THIS
OPPORTUNITY.
IT TRULY HAS BEEN A JOY.
>> THANK YOU SO MUCH.
REALLY, REALLY THOUGHT-PROVOKING
COMMENTS AND I APPRECIATE THEM.
ALL RIGHT.
I THINK WE'RE AT THE END OF THE
PROGRAM.
I GUESS WHAT I'LL LEAVE WITH YOU
IS JUST A REQUEST TO PLEASE LOOK
OVER THE SLIDES.
WE WILL SEND THEM TO YOU.
LET US KNOW IF YOU HAVE
QUESTIONS.
IN PARTICULAR, IF YOU HAVEFULLY
INTEREST IN PARTICIPATING IN A
WORK -- HAVE ANY INTEREST IN
PARTICIPATING IN A WORKING GROUP
AS A MEMBER OR TO BE INTERVIEWED
ON CLINICAL TRIALS, PLEASE LET
ME KNOW.
THANK YOU VERY MUCH TO DR.
PICARILLO FOR AGREEING TO
CO-LEAD THIS EFFORT.
WE'LL HOPE TO REPORT OUT AT A
LATER TIME.
SO, THANK YOU ALL, MEMBERS OF
COUNCIL.
THANKS TO EVERYONE WHO HAS
JOINED TODAY.
AND I WILL SEE MEMBERS OF
COUNCIL AGAIN TOMORROW FOR OUR
SECOND CLOSED SESSION.
TAKE CARE AND HAVE A GOOD
EVENING.
BYE-BYE.
[END OF PROGRAM]