OUR NATIONAL ADVISORY DENTAL
RESEARCH COUNCIL. I'M THE DES
DESIGNATED OFFICIAL FOR THIS
COUNCIL. FIRST SOME HOUSE
KEEPING ITEMS. WE WILL NOT BE
TAKING QUESTIONS FROM THE PUBLIC
BUT WE WILL ACCEPT THEM AT THE
E-MAIL ADDRESS THAT WILL BE
DISPLAYED AT THE END OF THIS
SESSION. A FEW TEAMS MEETING
LOGISTICS, THOSE ATTENDING VIA
TEAMS PLEASE ENSURE THAT YOUR
MICROPHONES ARE SET ON MUTE
UNLESS YOU ARE SPEAKING AND/OR
PRESENTING. COUNCILMEMBERS,
PLEASE KEEP YOUR VIDEO CAMERA
ON, ALL OTHERS, PLEASE KEEP YOUR
CAMERAS OFF UNLESS YOU ARE
PRESENTING OR SPEAK THIS IS
IMPORTANT IN THE WEBCASTING OF
THE OPEN SESSION IF ANYONE
PARTICIPATING VIA TEAMS NEEDS
TECHNICAL ASSISTANCE, MASON
FLETCHER AND DANIEL CARTER WILL
BE ABLE TO ASSIST. FINALLY
DURING THE VOTING PROCESS, IF
ANY COUNCILMEMBER IS OPPOSED OR
WOULD LIKE TO ABSTAIN WE ASK
THAT YOU SPEAK UP AS WELL AS
SEND A MESSAGE IN THE TEAMS
CHAT. BEFORE WE BEGIN, I'D LIKE
TO ASK THE COUNCILMEMBERS TO
BRIEFLY INTRODUCE THEMSELVES,
STATING THEIR NAMES, AFFILIATION
AND EXPERTISE. WE WILL GO IN
ALPHABETICAL ORDER WHEN I CALL
YOUR NAMES. STARTING WITH
DR. TERRY DICKINSON. PLEASE
UNMUTE YOURSELVES AND INTRODUCE
YOURSELF.
>> GOOD MORNING, MY NAME IS
TERRY DICKINSON AND I'M
ASSOCIATED WITH VIRGINIA COMMON
WEALTH UNIVERSITY SCHOOL OF
DENTISTY.
>> THANK YOU, DR. LISA.
>> GOOD MORNING, EVERYONE, MY
NAME IS LISA I'M FROM THE
COLLEGE OF DENTISTY AND MY
RESEARCH AREA IS TISSUE REGEN
RATION AND WOUND HEALING.
>> THANK YOU. DR. STEPHANIE.
>> GOOD MORNING, I'M STEPHANIE
FROM VANDERBILT UNIVERSITY
MEDICAL CENTER, MY SPECIALTY IS
BIOINFORMATICS. THANK YOU.
>> GOOD MORNING, I'M PAUL FROM
UCLA SCHOOL OF DENTISTY AND MY
EXPERTISE ARE IN CELL AND
MOLECULAR BIOLOGY OF TISSUES.
>> THANK YOU, DR. JOSÉ.
>> HI, I'M PROFESSOR OF THE
ANESTHESIOLOGY. MY RESEARCH IS
FOCUSED ON UNDERSTANDING THE
INTERSECTION OF PAIN AND OPIATE
ADDICTION.
>> GOOD MORNING, I'M JACQUES
NOR, FROM FES PROFESSOR IN
DENT
DENTISTY. OUR RESEARCH IS IN
STEM CELL BIOLOGY.
>> AND DR. AMY.
>> I'M AMY SLAP, AT NEW YORK
UNIVERSITY AND MY EXPERTISE IS
IN INTERNAL -- INTERPERSONAL
INTERACTIONS.
>> THANK YOU AND DR. KOUG WILL
NOT BE JOINING. THE NEXT ITEM
IS THE APPROVAL OF THE MINUTES
FROM THE PRIOR COUNCIL MEETING.
THEY WERE MADE AVAILABLE TO THE
COUNCILMEMBERS. ARE THERE
COMMENTS OR CORRECTIONS FOR THE
SEPTEMBER 2024 COUNCIL MEETING
MINUTES? HEARING NONE, WOULD A
MEMBER OF THE COUNCIL LIKE TO
MAKE A MOTION.
>> SO MOVED, JACQUES.
>> SOMEONE LIKE TO SECOND THAT
MOTION?
>> I'LL SECOND.
>> ALL IN FAVOR?
>> YES.
>> ANY OPPOSED? I'M HEARING
NONE. THANK YOU SO MUCH. THE
COUNCIL OPERATING PROCEDURES
WERE REVISED DURING THE CLOSED
SESSION OF THE JANUARY COUNCIL
THAT TOOK PLACE IN 2025. A COPY
IS AVAILABLE ON THE WEBSITE FOR
EVERYONE'S INFORMATION. NOW, WE
WILL GO TO THE NIDCR'S
DIRECTOR'S REPORT BY THE ACTING
DIRECTOR OF N IDCR, DR. WEBSTER.
>> HOW WONDERFUL TO BE HERE.
AND IT IS MY PLEASURE TO WELCOME
YOU. WE HAVE A LOT TO SHARE
WITH YOU, LOTS OF CHANGES. I'LL
GO AHEAD AND PUT IT IN
PRESENTATION MODE. SO AGAIN
WELCOME, LOTS OF UPDATES AND
NEWS TO SHARE WITH YOU IN
REGARDS TO THE BUDGET, THE
CONGRESSIONAL AND LEGISLATIVE
UPDATES, ADMINISTRATION UPDATES
RELATED TO OUR NEW
ADMINISTRATION AND THE VISION.
AS WELL AS ANNOUNCEMENTS FROM
NIH AND NIDCR AND THEN
AFTERWARDS, IN TERMS OF
SCIENTIFIC ADVANCES WE'LL BE
HIGHLIGHTING OUR INTRAMURAL
PROGRAM. WE'LL START WITH
APPROPRIATIONS AND BUDGET. SO
THE 119TH CONGRESS CONVENED THIS
JANUARY AND REELECTED MIKE
JOHNSON AS SPEAKER OF THE HOUSE
SINCE 2015 THIS IS THE FIRST
TRIFECTA WHERE ALL ARE
CONTROLLED BY A SINGLE PARTY.
IN MARCH OF THIS YEAR PRESIDENT
TRUMP SIGNED A CONTINUING
RESOLUTION SO WE'LL CONTINUE TO
OPERATE UNDER THIS CONTINUING
RESOLUTION THROUGH SEPTEMBER
30TH OF 2025 WHICH MEANS FOR US
THAT AT NIH WE'LL HAVE THE SAME
FUNDING LEVEL AS WE HAD IN 2024.
WITH NO REDUCTION. THAT WAS
48.9 BILLION FOR NIH AND FOR
NIDCR 520 MILLION. SO IN TERMS
OF 2026, EARLIER THIS MONTH ON
MAY 2ND THE WHITE HOUSE RELEASED
THE PRESIDENT'S BUDGET REQUEST
FOR FY 26 AND IT ONLY OUTLINED
MAJOR DISCRETIONARY FUNDING
CHANGES. FOR NIH THAT MEANS THE
PROPOSAL OF A 17.96 BILLION
DOLLAR DECREASE FROM '25. WHICH
BRINGS THE TOTAL FUNDING
PROPOSED FUNDING FOR NIH TO 30
BILLION AND FOR NIDCR WHAT HAS
BEEN PROPOSED IS A
REORGANIZATION OF THE ICS.
CONSISTENT WITH OTHER RECENT
REFORM PROPOSALS. WITH THE
PROPOSAL, THAT NIDCR BE MERGED
WITH NEA AND NINDS. UNDER THE
NATIONAL, THE UMBRELLA NATIONAL
INSTITUTE OF NEUROSCIENCE AND
BRAIN RESEARCH. SO WHAT'S NEXT?
CONGRESS HAS BEGUN TO HOLD
BUDGET MEETINGS AND HEARINGS
RELATED TO THIS REQUEST AND
CONGRESS WILL BE RESPONSIBLE FOR
DIRECTING THE GOVERNMENT
SPENDING. SO WE'LL HAVE TO SEE.
WITH REGARD TO LEGISLATIVE
UPDATES, THERE ARE NOW FOUR
DENTISTS IN THIS 119TH CONGRESS.
THERE WAS A FIFTH WHO DECIDED
NOT TO RUN FOR REELECTION AND
THESE INCLUDES REPRESENTATIVES
BABYLON BEGIN, GO SAR, AND DREW.
WE'VE HAD THE OPPORTUNITY TO
SHARE A BIT WITH CONGRESS ABOUT
WHO WE ARE. AND IN 2024 THE
OFFICE OF LEGISLATIVE POLICY
CREATED A SERIES CALLED ALLERGY
R LUNCH AND LEARN WHERE WE GET
TO SPEAK WITH CONGRESSIONAL
STAFF.
WE PARTICIPATED IN THIS PAST
JOON AND REVIEWED, WE OF COURSE
COMPLETED OUR 75TH ANNIVERSARY.
AND HAD THE OPPORTUNITY TO SHARE
WITH THEM OUR YEARS OF
ACHIEVEMENTS, WHAT OUR ROLE IS
AND IMPACTING THE PATHWAY TO
HEALTH AND HOW WE CANNOT HAVE
HEALTH WITHOUT ORAL HEALTH.
OKAY? WE'LL HAVE ANOTHER
OPPORTUNITY NEXT WEEK, JUNE 6TH,
WHERE WE'LL PRESENT AND RAISE
AWARENESS OF NATIONAL ORAL
HEALTH MONTH WHICH IS JUNE AND
WE WILL ALSO BE PROMOTING OUR
ROLE IN THE FIELD. SO AS YOU
ARE ALL THE AWARE WE HAVE A NEW
ADMINISTRATION THAT COMES WITH
NEW VISION. SO WE HAVE A NEW
HHS SECRETARY, ROBERT F. GENERAL
KENNEDY JR. AND A NEW NIH
DIRECTOR.
I WILL SHARE PRIORITIES
ARTICULATED BY OUR HHS SECRETARY
AND THE VISION THAT'S BEEN
SHARED BY JAY BARTY CHARIA. IN
TERMS OF HHS THERE'S BEEN
DISCUSSION ABOUT TACKLING MENTAL
HEALTH AND ADDICTION. TO
ADDRESS PHYSICAL ACTIVITIES AND
HEALTHY LIFESTYLES. ALL
IMPACTING ORAL HEALTH. TO FUND
CUTTING EDGE RESEARCH AT NIH
WHILE CUTTING NONESSENTIAL
SERVICES. AND TO ELIMINATE DEI
FUNDING TO FOCUS MORE ON
POVERTY. AND THIS IS ALSO TO
STRENGTHEN CYBERSECURITY AND
HEALTH IT. TO FOCUS ON DATA AND
SECURE USE OF AI AND TO SUPPORT
PUBLIC TRUST WITH A NEW ERA OF
TRANSPARENCY AND PUBLIC SERVICE.
FOR DR. BHATTACHARYA HIS VISION
INCLUDES IMPROVING POPULATION
HEALTH. SPECIFICALLY IMPROVING
PREVENTION, TREATMENT AND
CURIOUS FOR CHRONIC DISEASE.
WHICH RESONATES QUITE
SIGNIFICANTLY WITH THE WORK WE
DO AT NIDCR. TO ENSURE THE
RESULTS THERE NIH FUNDED
RESEARCH IS REPLICABLE AND
GENERALIZABLE AND TO FOSTER
INNOVATION, MAKE HUGE CHANGES.
WHILE MAINTAINING HIGH ETHICAL
STANDARDS, AND PRIORITIZING
HUMAN BASED RESEARCH
TECHNOLOGIES. TO WORK IN
COMPANION WITH ANIMAL BASED
STUDIES. TO REMAIN RESPECTFUL
OF DIFFERENT PERSPECTIVES AND,
AGAIN, TO RESTORE PUBLIC TRUST
IN SCIENCE. OKAY? SO WHAT'S
NEW HERE AT NIH? THERE HAVE
BEEN A LOT OF CHANGES AND
UPDATES SO LET'S START WITH
POLICIES THAT HAVE CHANGED.
OKAY? THE FIRST IS, WAS
RELEASED JUST THIS PAST MAY.
FOCUSED ON PAUSING POTENTIALLY
DANGEROUS RESEARCH THAT COULD
MAKE A NATURALLY OCCURRING
PATHOGEN OR TOXIN MORE DANGEROUS
TO OUR CITIZENS THIS WILL FOCUS
ON ENSURING SAFE AND SECURE
CONDUCT OF BIOLOGICAL RESEARCH
AND THERE'LL BE MORE GUIDANCE
COMING ON WHAT EXACTLY THAT'S
GOING TO LOOK LIKE. OKAY?
THERE'S ALSO THE SPRA INTRAMURAL
ACCESS PLANNING POLICY.
AND THIS IS TO MAKE SURE THAT
THOSE DISCOVERIES THAT OCCUR IN
THE CONTEXT OF THE INTRAMURAL
RESEARCH PROGRAM AND THE
INVENTIONS THAT RESULT IN DRUGS
AND BIOLOGICS AND VACCINES AND
DEVICES ARE ACCESSIBLE TO THE
AMERICAN PEOPLE. OKAY? SO
THOSE ORGANIZATIONS WHO WILL BE
APPLYING TO NIH FOR LICENSES
WILL BE REQUIRED TO SUBMIT
ACCESS PLANS TO MAKE SURE THAT
EVERYBODY HAS ACCESS TO THESE
PRODUCTS. THIS INCLUDES BEING
AFFORDABLE, AVAILABLE,
ACCEPTABLE AND BEING
SUSTAINABLE. AND THIS IS
ACTUALLY GOING TO APPLY
BEGINNING JUNE 1ST SO STARTING
NEXT WEEK. SO THAT'S BRINGING
SCIENCE TO PEOPLE. THERE'S ALSO
THE -- A POLICY UPDATE RELATED
TO NIH PUBLIC ACCESS. AND THIS
IS GOING TO APPLY TO ANY PAPER
THAT HAS RESULTED FROM NIH
FUNDING THAT HAS BEEN ACCEPTED
TO PUBLICATION IN A JOURNAL SO
MOVING FORWARD, ACCEPTED
MANUSCRIPTS SHOULD BE SUBMITTED
TO PUBMED FOR PUBLIC
AVAILABILITY WITHOUT EMBARGO AND
THIS IS ALSO GOING TO GIVEN NEXT
WEEK, JUNE 1ST. SO THESE PAPERS
WILL BECOME IMMEDIATELY
AVAILABLE TO THE PUBLIC. UNTIL
THEN, OVER THE NEXT FIVE DAYS OR
SO, THE CURRENT POLICY WILL
REMAIN IN EFFECT. OKAY? THERE
ARE LOTS OF CHANGES, LOTS OF
INITIATIVES AND NEW POLICIES.
HERE IS THE ONE-STOP SHOP,
PLEASE STAKE A... TAKE A LOOK AT
THIS PAGE SO YOU'LL BE ABLE TO
SEE WHAT ALL THE NEW INITIATIVES
AND POLICIES ARE.
THIS IS A CENTRAL LOCATION,
WHERE WE CAN SEE WHAT THE STATUS
IS OF CHANGES THAT WILL IMPACT
THE GRANT'S PROCESS SO PLEASE
TAKE A LOOK. OKAY? THERE ARE
CHANGES RELATED TO NIH GRANTS
AND AWARDS SO LET'S TAKE A FEW
MINUTES LOOKING AT WHAT THIS
WILL LOOK LIKE. IN APRIL OF
THIS YEAR, THERE WERE CHANGES TO
FEDERAL ANTIDISCRIMINATION LAWS.
OKAY? AND SO THERE'S NOW A
NOTICE RELATED TO CIVIL RIGHTS
TERMS AND CONDITIONS OF AWARDS.
AND WHAT THIS MEANS IS THAT ALL
NEW RENEWAL SUPPLEMENTS OR
CONTINUATION AWARDS MUST COMPLY
WITH THIS NEW FEDERAL
ANTIDISCRIMINATION LAW. THERE'S
ALSO BEEN SOME SIGNIFICANT
MOVEMENT OR CHANGES RELATED TO
FOREIGN SUBAWARDS. OKAY? AND
SO WE'LL BE ACTUALLY MOVING AWAY
FROM SUBAWARDS TO SUBPROJECTS.
OKAY? AND WHAT IS GOING TO
HAPPEN IS FOREIGN SUBAWARDS WILL
NO LONGER BE NESTED UNDER THE
PARENT GRANT. OKAY? I WANT YOU
TO RECOGNIZE THAT THIS IS THE
BEGINNING OF A PROCESS WHERE
THEY'LL BE STARTING WITH FOREIGN
SUBAWARD AND MOVING WITH ALL
SUBAWARDS. SO WHAT THIS NEW
AWARD STRUCTURE WILL LOOK LIKE
IS THAT THERE'LL BE A PRIME AND
THEY WILL GET AN INDEPENDENT
AWARD. AND THEN THE SUBPROJECT
WILL BE LINKED TO THE PRIME BUT
THE PERSON WILL APPLY
SEPARATELY. OKAY? AND THIS,
WHAT THIS WILL ALLOW NIH TO DO
IS TO BETTER TRACK THE PROJECT'S
FUNDS INDIVIDUALLY WHILE
SCIENTIFIC PROGRESS WILL BE
REPORTED COLLECTIVELY BY THE
PARENT, OR THE PRIME
INSTITUTION. OKAY? SO THIS IS
ALSO ASSOCIATED WITH MAKING SURE
THAT THERE'LL BE NO ISSUANCE OF
AWARDS TO DOMESTIC OR FOREIGN
ENTITIES IF THERE IS A SUBAWARD
ATTACHED. SO PLEASE PAY
ATTENTION BECAUSE THINGS THAT
WILL COME IN WILL NOT BE
REVIEWED IF YOU HAVE THE
SUBAWARDS ATTACHED THE WAY THAT
WE'VE DONE IT IN THE PAST.
OKAY? NIH IS GOING TO ALLOW
RENEGOTIATION OF AWARDS WHETHER
THEY'RE NEW, RENEWAL OR
NON-COMPETING TO REMOVE THE
SUBAWARDS AND TO BUILD IN THE
SUBPROJECTS. IF THE WORK CAN
ACTUALLY BE PERFORMED
DOMESTICALLY THAT WOULD BE
PREFERABLE, AND WE'LL ALLOW THE
FUNDS TO REBUDGETED FOR USE FOR
THE PRIME RECIPIENT, OKAY?
THERE'S ALSO NEW INFORMATION
RELATED TO SUBAWARDS AND SBIRS
STTRS, OKAY?
SO THERE'S A CHANGE IN POST
AWARD REPORTING REQUIREMENTS FOR
THE SBIRS AND STTRS, THE KEY
HERE IS THE REQUIREMENT TO
DISCLOSE ALL FUNDED AND UNFUNDED
RELATIONSHIPS WITH FOREIGN
COUNTRIES USING A NEW FORM THAT
IS THE REQUIRED DISCLOSURES OF
FOREIGN AFFILIATIONS OR
RELATIONSHIPS FORMS. OKAY? SO
IF THE RECIPIENT REPORTS A
FOREIGN RELATIONSHIP THAT
MEETINGS ANY OF THE RISK
CRITERIA, NIH MAY DEEM IT
NECESSARY TO ACTUALLY TERMINATE
THE AWARD. OKAY? FOR FAILURE
TO COMPLY SO THE KEY HERE IS
COMPLIANCE, PLEASE TAKE A LOOK
AT THIS NOTICE. AGAIN, ANOTHER
REMINDER RELATED TO FOREIGN
JUSTIFICATIONS. SO THERE'S A
FOREIGN JUSTIFICATION ATTACHMENT
THAT SHOULD DESCRIBE RESOURCES
AND CHARACTERISTICS OF THE
RESEARCH PROJECT. INCLUDING WHY
THE FACILITIES OR OTHER ASPECTS
OF THE PROPOSED PROJECT ARE MORE
APPROPRIATELY CONDUCTED IN A
FOREIGN SETTING VERSUS A
DOMESTIC SETTING. THIS
ATTACHMENT'S GOING TO BE
REQUIRED FOR EVERY APPLICATION
THAT INVOLVES ACTIVITIES OUTSIDE
OF THE U.S. OR ANY PARTNERSHIP
WITH AN INTERNATIONAL
COLLABORATOR. IRRESPECTIVE OF
WHETHER THE FOREIGN COMPONENT IS
RECEIVING FUNDS FROM THE NIH,
OKAY? IF THIS ATTACHMENT IS NOT
PROVIDED IN THE APPLICATION THE
APPLICATION WILL NOT BE
REVIEWED. OKAY? THERE'S ALSO
AN UPDATED PROCESS RELATED TO NO
COST EXTENSIONS. AND NIH AS OF
EARLIER THIS MONTH NIH IS
TEMPORARILY (ECHO) GOT IT? HAS
TEMPORARILY DISABLED THE NO COST
EXTENSION NALT. THERE'LL BE AN
ADDITIONAL LAYER OF REVIEW OF
ALL EXISTING GRANTS TO MAKE SURE
THAT NIH IS NOT FUNDING ANY OFF
MISSION ACTIVITIES OR PROJECTS.
ALL REQUESTS FOR -- NO COST
EXTENSIONS MUST BE SUBMITTED AS
PRIOR APPROVAL REQUESTS IN ERA
COMMONS FOR NIH REVIEW AND
APPROVAL. WHAT ABOUT NIDCR?
OKAY? WE'VE GOT SOME STAFF
UPDATES THAT I WOULD LIKE TO
SHARE WITH YOU AND TO WELCOME
OUR NEW STAFF. OKAY? FIRST IS
AARON CON DON HE IS OUR DEPUTY
EXECUTIVE OFFICER AND IS
CURRENTLY OUR ACTING EXECUTIVE
OFFICER. BEFORE COMING TO NIDCR
HE WAS THE DIRECTOR OF
MANAGEMENT FOR THE ALL OF US
RESEARCH PROGRAM AND HAS HAD
ROLES WITH NCI, WITH THE
INSTITUTE OF NURSING AND THE NIH
OFFICE OF THE DIRECTOR. OKAY?
PLEASE JOIN ME IN WELCOMING JAY
CHI YOUR REE KNOW TO A NEW ROLE
WHO BECAME THE ACTING SCIENTIFIC
DIRECTOR EARLIER THIS YEAR. HE
PREVIOUSLY SERVED AS THE ACTING
ASSISTANT SCIENTIFIC DIRECTOR
AND HEADS THE
ADDEKNOW-ASSOCIATED VIRUS
SECTION WHO STUDIES DISEASE AND
GENE THERAPY FOR SALLY VARY
GLAND DISORDERS.
ALSO PLEASE JOIN ME IN WELCOMING
IS A KNOW SUE NAY JA WHO IS THE
ACTING DIRECTOR OF THE DIVISION
OF EXTRAMURAL ACTIVITIES WHO IS
HERE ON DETAIL AT NIDCR AND HE
PREVIOUSLY SERVED AS DEPUTY
DIRECTOR OF THE DIVISION OF
EXTRAMURAL ACTIVITIES AT THE
NATIONAL INSTITUTE ON AGING FOR
OTHER A DECADE.
WE ALSO WELCOME MICHELE MCGIRL
WHO JOINED AS CHIEF OF THE
RESEARCH TRAINING AND CAREER
DEVELOPMENT BRANCH AND SERVED AS
ACTING DEA DIRECTOR PRIOR TO
SANA JA'S JOINING. IN TERMS OF
HER JOINING SHE SERVED AS A
PROGRAM DIRECTOR AT NCI AND THEN
SERVED AS ACTING DIVISION
DIRECTOR AND CHIEF OF RESEARCH
ADVANCEMENT PROGRAMS AT NIGMS
PRIOR TO THAT SHE WAS A FACULTY
MEMBER AT THE UNIVERSITY OF
MONTANA. I'D ALSO LIKE TO
WELCOME TYRONE SPAY DID I WHO IS
ACTING CHIEF OF STAFF HERE AT
NIDCR.
HE'D BEEN PREVIOUSLY SENIOR
ADVISOR TO THE NIH DEPUTY
DIRECTOR IN THE NIH OFFICE OF
THE DIRECTOR. AND PRIOR TO
COMING TO NIH HE HELD POSITIONS
IN GOVERNMENT RELATIONS, AND
ALSO IN ADVOCACY FOR THE
FEDERATION OF AMERICA SOCIETY
FOR EXPERIMENTAL BIOLOGY AND
ALSO THE AMERICA SOCIETY FOR
PLANT BIOLOGISTS. WE ALSO
WELCOME GEOFFREY KROOP NICK WHO
JOINED THE NIDCR AS OUR MEDICAL
MONITOR IN THE OFFICE OF
CLINICAL TRIALS OPERATIONS AND
MANAGEMENT. HE OVERSEAS THE
INSTITUTES BOTH EXTRAMURAL AND
INTRAMURAL MEDICAL PROGRAM. HE
WAS THE MEDICAL OFFICE AT THE
NATIONAL INSTITUTE OF CHILD
HEALTH AND HUMAN DEVELOPMENT,
OKAY? AND WE ALSO HAD SEVERAL
RETIREMENTS. AND I WOULD LOVE
TO THANK THESE INDIVIDUALS FOR
THEIR COMMITMENT AND SERVICE TO
NIDCR. AND I WILL NAME JUST A
FEW DR. LYNN KING, DR. LILLIAN.
AND DR. REENA. SOME BUDGET
UPDATES. OKAY? WHEN WE LOOK AT
OUR BUDGET AGAIN, IT IS NOT
CHANGED, WE REMAIN FLAT. OUR
ACTUALS FOR FY24 WERE 520.2
MILLION AND WHERE DID THAT
MUNGO? MOSTLY TO EXTRAMURAL AT
78.4%.
ABOUT 6.5% FOR RESEARCH
MANAGEMENT TO KEEP THE LIGHTS ON
AND 15.1% TO SUPPORT SPRA MURAL
SCIENCE HERE AT NIDCR. WHEN WE
BREAK DOWN FUNDING WE SEE A
LARGE PORTION OF THIS GOES TO
RESEARCH PROJECT GRANTS ABOUT
80%. 3% GOES TO RESEARCH
TRAINING. ABOUT 6% TO RESEARCH
AND DEVELOPMENT CONTRACTS.4% TO
SBIRS AND STTRS AND 7% TO OTHER
RESEARCH EFFORTS. OVER 400
MILLION TO THE EXTRAMURAL
COMMUNITY. AND WE LOOK AT OUR
APPROPRIATIONS HISTORY JUST BACK
FIVE YEARS TO 2020. WE CAN SEE
THAT THE VALUE OF THE DOLLAR IN
TERMS OF SPENDING JUST DOES NOT
STRETCH LIKE IT HAS IN THE PAST.
SO IN 2020 WE WERE AT 477
MILLION, OKAY? WE'RE NOW AT 520
MILLION, HOWEVER, THE
APPROPRIATIONS IN 2020 DOLLARS
ARE ONLY 452 MILLION. SO WHILE
WE'VE HAD SOME INCREASE, OUR
ACTUAL SPENDING POWER HAS
DECREASED HERE AT NIDCR. OKAY?
AND WHEN WE LOOK AT SUCCESS
RATES, WE HAVE DONE EQUAL TO OR
BETTER THAN NIH OVER THE LAST
FIVE YEARS. ENDING LAST YEAR AT
A SUCCESS RATE OF 19.1%. WE
INVEST SIGNIFICANTLY IN DEMO
SCHOOLS. WHILE PROVIDING ABOUT
61% OF DEMO SCHOOL FUNDING THAT
COMES FROM NIH AND WITH THE
OTHER 39% COMING FROM OTHER
INSTITUTES. DEMO SCHOOL FUNDING
ACCOUNTS FOR ABOUT 45% OF -- OR
43% OF OUR TOTAL EXTRAMURAL
BUDGET. NOW WHAT ABOUT OUR
PHASE AND APPROVED CONCEPTS?
OKAY? IF WE LOOK AT WHAT WAS
AWARDED LAST YEAR THERE WAS
SCIENCE ASSOCIATED WITH
UNDERSTANDING COINFECTIONS OF
HPV AND HIV AND THE IMPORTANCE
OF THESE COINFECTIONS IN THE
DEVELOPMENT OF ORAL PHARYNGEAL
CANCERS, THERE WERE FOUR GRANTED
FUNDED IN THAT SPACE. THERE
WERE TWO GRANTS FUNDED TO REALLY
ENGAGE COLLABORATIVE SCIENCE TO
ACHIEVE DISRUPTIVE INNOVATIONS
IN THE DENTAL, ORAL AND
CRANIOFACIAL SPACE AND THERE
WERE FOUR GRANTS FUNDED TO
DEVELOP CELEBRATORY COMPONENTS
AS THERAPEUTICS FOR ORAL HEALTH.
OKAY? THERE WERE THREE SOAR
AWARDS RELATED TO OUTSTANDING
ACHIEVEMENT AND RESEARCH. AND
THERE WAS ONE UC 2 AWARD FOCUSED
ON STRENGTHENING RESEARCH
OPPORTUNITIES FOR NIH GRANTS.
TO HELP WITH RESOURCE LIMITED
INSTITUTIONS. AND THIS WAS
ACTUALLY LED BY NIMHD. WHEN WE
LOOK AT WHAT'S CURRENTLY THERE,
WE HAVE ORGAN ON A CHIP AND
DENTAL, ORAL AND CRANIOFACIAL
RESEARCH AND THERE ARE R 01S AND
R 21S AVAILABLE THERE. THERE'S
ALSO THE REISSUE OF THE
COLLABORATIVE SCIENCE TO ACHIEVE
RIS RUNTIVE INNOVATIONS IN
DENTAL, ORAL AND CRANIOFACIAL
RESEARCH AND ALSO TMD IMPACT.
FOCUSED ON TMD COLLABORATIVE
THAT WILL IMPROVE PATIENT
CENTERED TRANSLATIONAL RESEARCH.
THESE ARE THE THREE FROM NIDCR,
OKAY? AND THEN THERE ARE THREE
CURRENT RFAS THAT OTHER
INSTITUTES ARE LEADING OUT ON.
THIS INCLUDES THE RARE DISEASES,
CLINICAL RESEARCH CONSORTIA FOR
RARE DISEASE CLINICAL RESEARCH
NETWORK, NCATS IS LEADING OUT
THERE. THERE'S THE PEDIATRIC
COHORT STUDY AND THE WHOLE
PERSON RESEARCH AND COORDINATION
CENTER THAT'S FUND -- THAT NCCIH
OR THE CENTER FOR COMPLEMENTARY
HEALTH IS LEADING OUT ON. OKAY?
I'D ALSO LIKE TO SHARE CONCEPTS
THAT ARE APPROVED BY COUNCIL.
THESE HAVE NOT BEEN RELEASED YET
BUT JUST TO SHARE WITH YOU WHAT
THE CONCEPTS ARE. THEY ARE
EXCITING. AND WELL-ALIGNED WITH
OUR STRATEGIC PLAN AS YOU CAN
SEE IN PURPLE OUR STRATEGIC
PRIORITIES. SO THE FIRST IS TO
ADVANCE PRECISION IMAGING FOR
ENHANCED DIAGNOSIS AND TREATMENT
OF ORAL LESIONS. THE SECOND IS
TO BE ABLE TO MOOD MODULATE THE
MICROBIOME TOWARDS HEALTH.
OKAY? THIRD IS TO INTEGRATE
MEDICALLY NECESSARY PREVENTION
TREATMENT AND MONITORING OF
ONCOLOGIC RELATED ORAL, DENTAL
AND CRANIOFACIAL COMPLICATIONS
BECAUSE AS YOU KNOW, ANY CANCER
ANYWHERE, TREATED WITH
CHEMOTHERAPY THOSE THERAPIES CAN
IMPACT ORAL CAVITY. THERE'S
ALSO COMMUNITY ENGAGED RESEARCH
TO ADVANCE ORAL HEALTH
INTERVENTION MODEL AND A DIGITAL
TWINS CONCEPT THAT IS FOCUSED ON
ADVANCING INNOVATION AND
OPTIMIZING CLINICAL OUTCOMES IN
DENTAL, ORAL AND CRANE OWE
OFFICIAL MEDICINE. AND FINALLY,
THE DENTAL PRIMARY CARE PRACTICE
SPACE RESEARCH NETWORK TO
SUPPORT RESEARCH IN CLINICAL
PRACTICES. OKAY? ONE COMMON
THEME ACROSS ALL OF THESE IS
PARTNERING AND COLLABORATING
WHERE WE'RE WORKING WITH OTHER
INSTITUTES TO MOVE THIS FORWARD:
OTHER NOTICES AND INITIATIVES
FROM NIDCR. NOTICES ANDI II IS
INITIATIVES COME IN THE FORM OF
THESE FUNDING OPPORTUNITIES.
AND TO SHARE WITH YOU MOVING
FORWARD THERE'LL BE FEWER OF
THESE AS NIH IS WORKING TO
CONSOLIDATE AND HAVE BROADER
UMBRELLA NOFOS THAT MULTIPLE
INSTITUTES ARE ABLE TO SIGN
ONTO. I WILL SHARE WITH YOU
WHAT WE HAVE COMING DOWN THE
PIKE BUT JUST RECOGNIZE THAT
MOVING TO -- FORWARD YOU'LL SEE
FEWER OF THESE AVAILABLE TO THE
COMMUNITY BUT THOSE
OPPORTUNITIES STILL EXIST WITHIN
THE UMBRELLA CONCEPT NIDCR WILL
BE THERE.
SO THE FIRST ONE, FIRST SET OF
FUNDING OPPORTUNITIES I WOULD
LIKE TO FOCUS ON ARE THOSE
ASSOCIATED WITH CLINICAL TRIALS.
OKAY? AND THESE ARE COMING UP,
LIKE IN THE NEXT WEEK. WITH THE
FIRST ONE FOCUSED ON DRUG
BIOLOGIC DEVICE AND/OR PROCEDURE
INTERVENTION CLINICAL TRIAL
PLANNING AND IMPLEMENTATION.
OKAY? FOR NEW APPLICATIONS,
THAT'S DUE JUNE 6TH. THE NEXT
ONE IS FOCUSED ON BEHAVIORAL AND
SOCIAL INTERVENTION CLINICAL
TRIAL PLANNING AND
IMPLEMENTATION. THIS
APPLICATION FOR THIS COOPERATIVE
AGREEMENT IS ALSO DUE JUNE 6TH
FOR NEW APPLICATIONS. AND DUE
IN JULY ARE CONTINUATION OR
REVISION OF CLINICAL TRIAL
PLANNING AND IMPLEMENTATION.
COOPERATIVE AGREEMENTS. SO
THAT'S CLINICAL TRIALS RELATED
TO HEAL INITIATIVES THAT ARE
PAIN FOCUSED WHERE NIDCR IS
INVOLVED. LET'S SEE, WE JUST
PASSED ONE, FOCUSED ON ANALGESIC
DISCOVERY. COMING UP IN OCTOBER
IS THE PAIN RESEARCH ENHANCEMENT
PROGRAM INITIATIVE AND THAT IS
DUE OCTOBER 28TH AND ALSO COMING
UP IN JUNE IS THE EARLY STAGE
DISCOVERY PAIN TARGETS WITHIN
THE DRUGGABLE PROTEOME AND THIS
IS DUE JUNE 16TH. AND THE SPACE
OF HIV/AIDS THERE'S BASIC AND
TRANSLATIONAL ORAL HEALTH
RESEARCH RELATED TO THE SYSTEMIC
CONDITION. WITH R 01S DUE IN
JUNE. JUNE 5TH. AND R 21S DUE
JUNE 16TH. THE FOCUS HERE ARE
BASIC STUDIES THAT INVOLVE
HUMANS. OKAY? THIS IS A NOTICE
OF EXPIRATION AND IS NO LONGER
GOING TO BE COVERED. THIS IS ON
CORONAVIRUS DISEASE. THE
INVOLVEMENT OF THE ORAL CAVITY
IN CORONAVIRUS DISEASE WILL NOT
BE MOVING FORWARD. OKAY? WE
ALSO HAVE SOME NOTICES OF
FUNDING OPPORTUNITIES RELATED TO
TRANSLATIONAL RESEARCH. OKAY?
ALL OF THESE ARE ALSO DUE IN
JUNE OF THIS YEAR WITH THE FIRST
ONE FOCUSED ON, IT'S A CTSA
AWARD, FOCUSED ON COLLABORATIVE
AND INNOVATIVE ACCELERATION, THE
SECOND ONE FOCUSED ON
EXPLORATORY AND DEVELOPMENTAL
BUY GROW ENGINEERING AND OF
COURSE ITS APPLICATION TO DOC
AND THE NIDCR PERSPECTIVE
OBSERVATIONAL AND BIOMARKER
VALIDATION STUDIES. ARE ALSO
DUE IN JUNE OF THIS YEAR. OKAY?
WITH REGARD TO DATA ANALYSIS,
OKAY, THERE IS A SMALL RESEARCH
GRANT FOCUSED ON ORAL HEALTH
DATA ANALYSIS AND STATISTICAL
METHODOLOGY DEVELOPMENT. THIS
IS AN R 03. IT'S ALSO DUE JUNE
16TH OF THIS YEAR. AND WE HAVE
ANALYSIS FOR EXISTING GENOMICS
DATA BOTH A SMALL GRANT, R 03
DUE IN JUNE, AND THEN AN R 01
EFFORT THAT'S DUE ALSO IN JUNE
BUT THE APPLICATION DATES ARE
DIFFERENT. WITH THE SMALL GRANT
BEING DUE ON THE 16TH AND THE R
01 DUE ON JUNE 5TH. OKAY? AS
WE'RE SPEAKING ABOUT DATA I JUST
WANT TO SHARE WITH YOU THE
LAUNCH EARLIER THIS YEAR OF THE
DDS HUB WHICH STANDS FOR
DATA-DRIVEN SCIENCE. AND THE
PUN IS INTENDED. DDS HUB PLEASE
GO THERE AND DDS HUB NIH.GOV AND
WITHIN THIS HUB, WE HOPE TO HELP
MOVE FORWARD DATA-DRIVEN
DISCOVERY THAT WILL IMPROVE
HEALTH FOR ALL. THIS HUB IS
CENTERED ON COMMUNITY
ENGAGEMENT, ON COLLABORATION AND
DISSEMINATION AND IS REALLY A
ONE-STOP SHOP HERE FOR DATA,
SHARING AND MANAGEMENT, HOW TO
DO IT, SO WE CAN MAKE SURE THAT
WE ARE PROMOTING TRANSPARENCY,
REPRODUCIBILITY AND DATA REUSE.
AND THEN TAKING THESE DATA AND
UTILIZING IT TO HELP DEVELOP NEW
INFORMATION, NEW DATA, USING
GUIDELINES TO GENERATE FAIR DATA
WITHIN STANDARDIZED THE
TERMINOLOGIES AND COMMON DATA
ELEMENTS.
OKAY IN THAT ALSO ARE
CLOUD-BASED ANALYTIC RESOURCES
THERE. SO YOU CAN BRING THESE
DATA TOGETHER AND ASK NEW
QUESTIONS IN THE CLOUD AND HERE
WE'RE COLLABORATING WITH NIGMS
AND NINHD TO BRING IN
COMPUTATION PAL -- RESOURCES
THAT ARE LOW CODE. AND THERE'S
ALSO DATA CURATION AND REUSE.
WITH OPPORTUNITIES FOR SELF
CURATION SO AS THE DATA GOES IN
IT'LL BE AI AND MACHINE LEARNING
READY TO GO. SO OPPORTUNITIES
TO CURATE EXISTING POPULATION
LEVEL DATA, DOWN TO THE
MOLECULAR DATA ALL THE WAY
THROUGH FROM THE MOLECULE TO THE
MASSES. SO ALL TYPES OF DATA
THERE. AND THERE'LL ALSO BE
INFORMATION FOR YOU THERE.
INFORMATION THAT WILL LET YOU
KNOW ABOUT WHAT'S COMING UP WITH
REGARD TO GRANTS AND FUNDING
OPPORTUNITIES THAT ARE RELATED
TO DATA AND DATA-DRIVEN SCIENCE.
WE'VE BEEN WORKING TO
COLLABORATE WITH MANY GROUPS AND
SO YOU SEE JUST A SNAPSHOT ON
THE RIGHT SIDE OF THE SLIDE OF
THE TYPES OF DATA THAT ARE
THERE. THERE'S DATA FROM ALL OF
US FROM THE WISCONSIN
COLLABORATIVE, FROM THE AMERICAN
DENTAL ASSOCIATION FROM THE BIG
MOUTH REPOSITORY AND APPLE TREE
DENTAL AND OTHERS. SO THAT'S A
SNAPSHOT OF SOME OF THE HUMAN
DA.
BUT THERE ARE ALSO DATA THAT
COME FROM COMPARATIVE GENOMES,
FROM ZEBRAFISH ON UP TO HUMANS.
AND OTHER TYPES OF DATA. SO
TAKE A VISIT TO THE HUB, HERE IS
THE QR CODE HERE AND WHAT YOU'LL
SEE IS THAT WE HERE ARE VERY
ALIGNED WITH THE NIH STRATEGIC
PLAN FOR DATA SCIENCE. SO I
INVITE YOU TO EXPLORE AND TO
TAKE ADVANTAGE AND TO UTILIZE
THE SITE TO REMAIN IN COMPLIANCE
WITH DATA MANAGEMENT AND
SHARING. OKAY? THERE ARE ALSO
SOME SIGNIFICANT ANNOUNCEMENTS
RELATED TO TRAINING. OKAY? SO
OPPORTUNITIES TO COMBAT TO
CAMPUS HERE AT NIH HAS OPENED
BACK UP. SO WE'VE RESTARTED
RECRUITMENT FOR INTRAMURAL
RESEARCH TRAINING AWARDS AND
ALSO FOR THE NCI CANCER RESEARCH
TRAINING PROGRAM SO THE HIRING
MECHANISMS ARE IN PLACE FOR
POSTDOCS FOR PREDOCS AND FOR
POSTBACS WHO HAVE U.S.
CITIZENSHIP OR PERMANENT
RESIDENCY THE REQUIRING WAS
PAUSED IN JANUARY BUT NOW
REOPENED IN APRIL. SO IF YOU'RE
INTERESTED, PLEASE APPLY, AND WE
LOOK FORWARD TO HAVING YOU.
OKAY? THERE HAVE BEEN A
SIGNIFICANT NUMBER OF CHANGE TO
THE TRAINING NOTICES. OKAY? WE
ARE GOING TO BE PARTICIPATING IN
A PARENT AWARD MECHANISMS.
THESE INCLUDE SEVERAL, ALL OF
THE F TYPE NOFOS, THE F 30, 31,
32, 33 AND THE NOFOS ARE IN
PREPARATION FOR AUGUST DUE
DATES. THE KEY HERE IS THAT YOU
MUST USE FORM I. THIS IS A NEW
FORM. OKAY? SO THOSE, THAT'S
THE FORM THAT MUST BE UTILIZED.
OKAY? FOR THOSE WHO ARE MAKING
THE TRANSITION FROM PREDOC TO
POSTDOC THAT FELLOWSHIP AWARD,
NIDCR WILL BE PARTICIPATING IN
THE PARENT F99 K 00. WE WON'T
HAVE A SEPARATE ONE. WE'LL
PARTICIPATE IN THIS PARENT AWARD
THAT'S BEING DEVELOPED. OKAY?
WE ARE ALREADY PARTICIPATING IN
PARENT AWARDS FOR THE K SERIES.
K 01, K 02, K08, K23, K25 AND
THE K99 R 00 NOTICES. OKAY?
AND RELATED TO THE DUAL DEGREE
SCIENTISTS PATHWAY TO
INDEPENDENCE AWARD THE
ANTICIPATED FIRST DUE DATE IS
JULY 12TH.
SO THIS SUMMER OF 2025 AND
FINALLY THE NRSA INSTITUTIONAL
RESEARCH TRAINING GRANTS WHICH
IS A PARENT T32, THE NEXT DUE
DATE FOR THAT WILL BE IN
SEPTEMBER OF THIS YEAR. OKAY?
SO A LOT OF CHANGES RELATED TO
TRAINING, AND PLEASE TAKE A LOOK
AT THE WEBSITE FOR ADDITIONAL
INFORMATION THERE. OKAY? SOME
ADDITIONAL CHANGES HERE ARE THE
TRANSITION AWARD FROM THE DENTAL
SCIENTISTS CAREER AWARD. THAT
IS NEXT DUE IN JUNE 12TH FOR NEW
APPLICATIONS. THERE'S ALSO
OPPORTUNITIES WITH REGARD TO THE
SMALL GRANT PROGRAM FOR NEW
INVESTIGATORS. THESE ARE R 03
AWARDS THOSE ARE ALSO DUE IN
JUNE. OKAY? AND THEN FINALLY,
WE HAVE THE RESEARCH ENHANCEMENT
AWARD PROGRAM FOR HEALTH
PROFESSIONAL SCHOOLS AND
GRADUATE SCHOOLS. THAT'S THE
R15. AND THAT'S ALSO DUE IN
JUNE ON JUNE 25TH FOR NEW
APPLICATIONS. OKAY? AND THEN
WE HAVE THE R 25 RESEARCH
EDUCATION AWARD. THIS IS THE
SCIENCE PARTNERSHIP EDUCATION
AWARD EXPERIENCE. OH, WAIT A
MINUTE, THE RESEARCH EDUCATION
AWARD IS NEXT DUE MARCH 17TH.
THE SEPA AWARD WE EXPECT TO
PARTICIPATE IN. IT'S NOW UNDER
DEVELOPMENT SO KEEP YOUR EYES
OPEN FOR THAT. THIS HELPS TO
SUPPORT EDUCATIONAL ACTIVITIES
FROM PRESCHOOL UP TO K-12. SO
NOT ONLY FOR THE STUDENTS BUT
ALSO THE TEACHERS TO MAKE SURE
THAT PEOPLE KNOW THAT THERE ARE
OPPORTUNITIES THAT THEY TOO CAN
BE A DENTIST OR A DENTAL
RESEARCHER. OF COURSE THAT'S
OUR INTERESTS BUT THE BROADER
INTEREST IS IN PURSUANCE OF STEM
CAREERS, OKAY? THERE HAVE ALSO
BEEN AN UPDATE IN PROCEDURES AND
RELATED TO CHILD CARE COSTS SO
RIGHT NOW THE ANNUAL CHILD CARE
COSTS ARE ABOUT 3,000 DOLLARS
FOR FULL-TIME APPOINTMENT SLOTS.
OKAY. NOW WHEN THE AWARD IS
AWARDED THEY ARE RESTRICTED TO
CHILD CARE EXPENSES. SO IF
THOSE FUNDS AREN'T USED, THEY
JUST NEED TO BE REPORTED AS AN
UNOBLIGATED BALANCE. THEY
CANNOT BE REBUDGETED. OKAY?
THERE'S ALSO BEEN SOME CHANGED
TO THE FELLOWSHIP REVIEW
CRITERIA.
THIS IS AN ALIGNMENT WITH THE
SIMPLIFIED REVIEW PROCESS THAT I
SHARED THE LAST TIME WE SPOKE
LAST FALL. BUT JUST TO LET YOU
ALL KNOW THAT THE FOCUS HERE IN
THE FELLOWSHIP REVIEW IS TO MAKE
SURE THAT THE MOST PROMISING
CANDIDATES ARE CONSISTENTLY
IDENTIFIED. TO MAKE SURE THAT
THERE'S A BROAD RANGE OF
CANDIDATES AND TO REDUCE BIAS BY
EMPHASIZING THE MENTOR'S
COMMITMENT TO THE CANDIDATE
WITHOUT HEAVY EMPHASIS ON THE
REPUTATION OF THE SPONSOR OR OF
THE INSTITUTE. OKAY? SO THESE
REVIEW CRITERIA ARE NOW THREE
FACTORS FOCUSED ON THE
CANDIDATE, HOW PREPARED THEY ARE
AND WHAT THEIR POTENTIAL IS ON
THEIR RESEARCH TRAINING PLAN AND
WHAT THE COMMITMENT IS TO THE
CANDIDATE FROM THE MENTOR AND
FROM THE INSTITUTION. NO GRADES
NEED TO BE SUBMITTED ON THE
BIOSKETCH, OKAY? SO THAT'S
ACTUALLY NO LONGER ALLOWED. AND
THIS WILL APPLY TO ALL THE
DIFFERENT F AWARDS IN THE NOFOS
OR IN THE PROCESS OF BEING
REISSUED. OKAY? SO THERE'S A
LOT GOING ON. THESE DAYS.
OKAY? AND NIDCR IS WORKING TO
ADDRESS THESE AREAS OF CONCERN.
WHY? BECAUSE ORAL HEALTH IS A
MAJOR PUBLIC HEALTH CONCERN.
OKAY? THE COST OF ORAL HEALTH
ARE HIGH TO THE ECONOMY, IT'S A
TOP CONCERN FOR MILITARY
READINESS AND WHEN WE THINK
ABOUT CHRONIC DISEASE, THESE ARE
THE MOST COMMON CHRONIC DISEASES
OR AMONG THE MOST CHRONIC
DISEASES, CARRIES, PER RIO
DONNAL DISEASE, ORAL CANCER,
TMD, AND DISEASES THAT MANIFEST
IN THE HEAD AND NECK. WHEN WE
THINK ABOUT CARIES AND
PERIODONTAL DISEASE THESE ARE
THE MOST COMMON DISEASES AND THE
MOST COMMON DISEASES OF
CHILDHOOD OF ADULTHOOD, THESE
ARE PREVENTIBLE. OKAY? AND THE
OTHER THING THAT WE KNOW IS THEY
CAN REALLY, NEGATIVELY IMPACT
MANY OTHER CHRONIC DISEASES. SO
NOT ADDRESSING THESE MEANS IT'LL
BE VERY DIFFICULT TO SOLVE THE
CHRONIC DISEASE CRISIS IN THE
U.S. WITHOUT ADDRESSING THE
INFLAMMATION OF THE DISEASE THAT
OCCURS HERE BECAUSE IT'S A
THREAT TO HEALTH EVERYWHERE
ELSE. OKAY? AND WHEN WE LOOK
AT, IF WE JUST LOOK AT IT
GRAPHICALLY AT CHRONIC DISEASES
AND WE JUST LOOK AT TOOTH DECAY,
FOR EXAMPLE, OUR POPULATION IN
THE U.S. IS 333 MILLION. 90% OF
THOSE PEOPLE HAVE HAD AN
EXPERIENCE WITH TOOTH DECAY,
OKAY? NOW WHEN WE COMPARE THIS
CHRONIC DISEASE TO OTHER CHRONIC
DISEASES, THAT THESE ORAL
CONDITIONS CAN EFFECT, WE CAN
SEE IT'S MUCH LARGER COMPARED TO
CARDIOVASCULAR DISEASE, MENTAL
HEALTH ISSUES, CANCER,
RESPIRATORY DISEASE AND DIABETES
IT'S A MAJOR PROBLEM AND HAS BY
DIRECTIONAL RELATIONSHIPS WITH
ALL THESE OTHER DISEASES, OKAY?
WHEN WE THINK ABOUT THE
PREVENTION OF THIS, OKAY? WHAT
YOU EAT, WHAT YOUR DIET IS AND
WE'RE COLLABORATING WITH THE N
FDA THERE, WHETHER YOU HAVE
ACCESS AND THE QUALITY OF THE
ACCESS WHAT YOU'RE ABLE TO
RECEIVE IN TERMS OF DENTAL CARE
WHAT YOU DO AT HOME, DO YOU KNOW
WHAT TO DO IN WHAT YOUR HYGIENE
IS, WHAT YOUR HABITS ARE? WHAT
IS YOUR LEVEL OF EDUCATION? AND
WHETHER YOU HAVE ACCESS TO
DENTAL PRODUCTS AND PROCEDURES.
OKAY? ALL OF THESE THINGS ARE
IMPORTANT TO PREVENT DISEASE.
OKAY? BUT THESE ARE ALL
DEPENDENT ON YOUR CONDITIONS OF
YOUR DAILY LIFE. THESE ARE ALL
STRUCTURAL FACTORS. OKAY?
FLUORIDE HELPS PREVENT THESE
DISEASE? IS IT A MAGIC BULLET?
NO. IT'S OPTIMALLY A TOOL IN A
TOOLBOX TOGETHER WITH THESE
OTHER ONES WHAT WE KNOW IS IF WE
REMOVE IT FROM THE WATER WE'LL
SEE A TWOFOLD INCREASE IN
DISEASE. HOW DO WE KNOW THIS?
BECAUSE THAT'S WHAT'S HAPPENED
IN ISRAEL, IN CALGARY, IN CANADA
AND THAT'S WHAT HAS HAPPENED
HERE IN THE U.S. IN JUNE NEO,
ALASKA AND MORE RECENTLY IN
BUFFALO SO WHAT ARE WE DOING?
OKAY? WE ARE WORKING TO BOLSTER
THE RESEARCH.
BECAUSE WE NEED TO ANSWER
QUESTIONS ABOUT FLUORIDE'S
IMPACT ON THE HEALTH OF THE U.S.
POPULATION AT THE LEVELS THAT
ARE PROTECT HERE IN THE U.S.
AND WE NEED TO HAVE THE RESEARCH
AND THE INFORMATION. SO THAT
PEOPLE ARE EMPOWERED TO MAKE THE
DECISION THEMSELVES. ABOUT
THEIR FLUORIDE USE AND INTAKE.
SO WHAT IS BOLSTERING RESEARCH
LOOK LIKE? WE NEED TO HAVE MORE
STUDY TO REALLY FULLY UNDERSTAND
THE IMPACTS OF FLUORIDE AT
LEVELS PRESENT IN THE U.S. WE
HAVE SOME STUDIES ONGOING THAT
ARE HELPING US TO ANSWER THESE
QUESTIONS. IN THE CONTEXT OF
INVESTIGATOR INITIATED RESEARCH
BOTH IN NORTH CAROLINA AND IN
IOWA AND OTHER PLACES. WE NEED
TO ALSO LEVERAGE ONGOING
LARGE-SCALE LONGITUDINAL STUDIES
TO TAP INTO EXISTING HEALTH
SURVEILLANCE DATA AND TO
ENCOURAGE SECONDARY DATA
ANALYSES ACROSS LARGE STUDIES
WHERE THAT INFORMATION IS
AVAILABLE OKAY? WE HAVE ALSO A
SIGNIFICANT AMOUNT OF
INVESTIGATOR INITIATED RESEARCH
ON WHAT HAPPENS AT VERY HIGH
LEVELS OF FLUORIDE EXPOSURE IN
ANIMAL MODELS AND ELSEWHERE.
OKAY? BUT HOW DO WE, WHY IS IT
IMPORTANT TO EMPOWER PEOPLE TO
MAKE INFORMED DECISIONS? THERE
ARE A LOT OF CONSIDERATIONS WHEN
PEOPLE MAKE A DECISION. THESE
DEPEND ON A LOT OF THINGS, YOUR
HEALTH, YOUR ETHICS, YOUR
RELIGION SOMETIMES, YOUR
POLITICS, SOCIAL, WHAT HAVE YOU.
OKAY? IF PEOPLE LEAN ON THEIR
INTUITION IT'S LIKE PUTTING A
SQUARE PEG INTO A ROUND HOLE.
OKAY? BUT WE HAVE THE
OBLIGATION HERE AT NIDCR TO HELP
PROVIDE THE EVIDENCE, SO PEOPLE
CAN MAKE SENSE OF IT FOR
THEMSELVES, ARE EMPOWERED TO
PULL THE PUZZLE TOGETHER AND
DECIDE FOR THEM WHAT THEY NEED
TO MOVE FORWARD. OKAY? AND
THAT COMES IN THE FORM OF
INFORMATION AND ACTUALLY HERE'S
A WEBSITE DOWN ON THE BOTTOM OF
THE PAGE THAT WILL BRING YOU TO
OTHER AREAS WHERE WE HAVE GOT
INFORMATION. WE NEED TO MAKE
SURE THAT WE'RE SUPPORTING THE
NATION'S DENTAL RESEARCH.
THERE'S BEEN LOTS OF CHANGES
OVER THE RECENT PAST. THERE
HAVE BEEN CHANGES IN TERMS OF
THE LEADERSHIP AT HHS AND HERE
AT NIH AND THERE HAVE BEEN SOME
NEW POSITIONS THAT HAVE BEEN
CREATED WITH REGARD TO
LEADERSHIP HERE. THE RESEARCH
PRIORITIES ARE ASSOCIATED WITH
MAKING AMERICA HEALTHY. WHICH
IS GREAT. AND CHRONIC ILLNESS.
WHICH IS SIGNIFICANT TO US IN
ORAL HEALTH AND NUTRITION AS
WELL. THERE HAVE BEEN
SIGNIFICANT CHANGES TO THE NIH
WORKFORCE WITH NIDCR LOSING
ABOUT 21% OF OUR WORKFORCE AND
MANY UPDATED POLICIES THAT I'VE
SHARED WITH YOU EARLIER AND
THERE'S BEEN A REIMAGINING OF
THE NIH STRUCTURE WHICH I ALSO
SHARED WITH YOU EARLIER BUT WHAT
ARE OUR GOALS? OKAY? OUR GOALS
ARE TO CONTINUE TO SUPPORT THE
BEST SCIENCE, TO MAKE SURE THAT
OUR PORTFOLIO OF DENTAL ORAL AND
CRANIOFACIAL RESEARCH CAN
TRANSFORM THE HEALTH OF THE
NATION AND TO MAKE SURE THAT
ORAL HEALTH REMAINS AT THE FORE
FRONT OF HIH AND -- NIH AND THE
PRIORITIES.
AND WE'RE OF COURSE FOCUSED ON
GOAL STANDARD SCIENCE. OKAY?
SO I AM GOING TO STOP THERE.
AND TAKE QUESTIONS. AND THEN
WE'LL HEAR ABOUT SCIENCE
ADVANCES RELATED TO OUR
INTRAMURAL PROGRAM.
>> THANK YOU VERY MUCH
DR. WEBSTER. WE CAN NOW TAKE
QUESTIONS FROM COUNCILMEMBERS
PLEASE UNMUTE YOURSELVES AND ASK
YOUR QUESTION. DOCTOR?
>> THANK YOU, THAT'S A LOT OF
INFORMATION. IS MOST OF THIS ON
THE WEBSITE? IS MOST OF THIS
INFORMATION ALREADY ON THE
WEBSITE THAT WE CAN GO BACK AND
DIGEST AND STUDY?
>> YES.
>> OKAY. AND SECONDLY, YOU
MENTIONED ABOUT THE BUDGET AND
THEN YOU MENTIONED ABOUT THE
PLANNING FOR REORGANIZATION IS
THAT ACTIVELY BEING PURSUED
RIGHT NOW BY TEAMS AND WHATEVER
THAT CONGRESSIONAL PLAN WAS FROM
LAST YEAR?
>> SO WE ARE PART OF THE
EXECUTIVE BRANCH AND SO NIH HAS
TO ALIGN WITH THE PRESIDENT'S
BUDGET. AND THE REQUEST FROM
THE PRESIDENT WAS AN ALIGNMENT
OF THE NIH BUDGET AND
ORGANIZATION OF NIH WITH THAT
PLAN. THAT WILL THEN MOVE TO
CONGRESS AND THE CONGRESSIONAL
JUSTIFICATIONS HAVE MOVED
FORWARD. AND THE CONGRESS WILL
DECIDE ABOUT THE BUDGET AND
CONGRESS WILL DECIDE ABOUT THE
REORGANIZATION. NOT EXACTLY THE
SAME BUT IN 2017, THERE WAS A
PROPOSAL THAT THERE WAS A 20 OR
30% DECREASE TO NIH. AND IN
FACT CONGRESS DECIDED THAT NIH
WOULD GET AN INCREASE THAT YEAR.
SO WE'RE IN THE PROCESS OF
WAITING. NOTHING'S DEFINITIVE
AND THERE'S A LOT OF DECISIONS
THAT REMAIN TO BE MADE.
>> THANK YOU.
>> DOCTOR, PLEASE UNMUTE
YOURSELF.
>> THANK YOU FOR YOUR
PRESENTATION, I HAVE A QUESTION
ABOUT ONE OF THE CHANGES THAT
YOU ALSO MENTIONED WITH THE
SUBCONTRACTS. THAT THERE ARE
GOING TO BE ALLOWANCE OF
CONTRACTS AND THERE'LL BE A
PARENT APPLICATION AND THEN, YOU
KNOW, THERE'S A COLLABORATION
THAT INSTITUTE WILL NEED TO
ACTUALLY SUBMIT AN APPLICATION
LINK TO THE PARENT APPLICATION.
WHEN IS THAT IMPLEMENTED? THERE
ARE MANY PEOPLE SUBMITTING
CONTRACTS UNDER REVIEW IS THAT
HAPPENING RIGHT NOW OR WHEN IS
THAT GOING TO BE IMPLEMENTED?
>> YEAH. THAT'S GOING TO HAPPEN
RIGHT NOW. OKAY? AND SO
THERE'S NOT GOING TO REALLY BE
ANY DELAY AND FOR CURRENT
AWARDS, THEY'LL NOW NEED TO BE
REASSESSED. AND THERE'LL NEED
TO BE JUSTIFICATIONS PROVIDED
FOR THOSE AND THERE'LL NEED TO
BE AN OPPORTUNITY FOR THE
SUBPROJECT TO APPLY. THERE'LL
ALSO BE THE OPPORTUNITY TO
REBUDGET AND MOVE THAT PART OF
THE PROJECT INTO THE U.S. IF
THERE'S A DOMESTIC COLLABORATOR
THAT CAN PROVIDE SIMILAR
SCIENTIFIC EXPERTISE. ANY THANK
YOU, DR. PIETRO, YOU'RE NEXT
>> THANK YOU, I WANT TO THANK
YOU FOR GIVING US THAT TERRIFIC
UPDATE. IT WON'T SURPRISE
ANYONE HERE TO KNOW THAT THERE'S
BEEN A LOT OF ALARM ABOUT THIS
CONCEPT OF REORGANIZING THE ICS
AND PARTICULARLY OF CHANGING
NIDCR OR MERGING IT WITH OTHER
INSTITUTES PARTICULARLY WHEN I
THINK ALL OF US AGREE THAT THIS
IS A VERY IMPORTANT INSTITUTE
AND IMPORTANT PART OF HUMAN
HEALTH AND IMPORTANT SCIENTIFIC
ENDEAVOR. WHAT CAN WE DO? IS
THERE ANY OPPORTUNITY FOR PUBLIC
COMMENT? OR OTHER COMMENT AS
THIS PROCESS UNFOLDS? OR WILL
THAT BE OF ANY IMPACT?
>> SO IT'S WITHIN THE RIGHTS OF
ANY CITIZEN TO SHARE THEIR
THOUGHTS AND INSIGHTS WITH THEIR
ELECTED OFFICIALS. SO THAT'S AN
AREA OF OPPORTUNITY. TO LET
THOSE INDIVIDUALS KNOW HOW
CRITICAL ORAL HEALTH IS AND HOW
CRITICAL THE SCIENCE IS. AND
HOW DIFFERENT NIDCR MAY BE
COMPARED TO OTHER INSTITUTE
WHERE IS WE LEAD A PROFESSION IN
TERMS OF THE RESEARCH. A FULL
PROFESSION AND ITS 12
SPECIALTIES. AND AUXILIARIES.
>> THANK YOU. AND WHAT IS THE
TIMING SORT OF OF THIS? BECAUSE
YOU MENTIONED THERE WOULD BE
SOME, THE EXECUTIVE I THINK YOU
CALLED IT THE EXECUTIVE
COMMITTEE OR BOARD WOULD BE
ALIGNING WITH RECOMMENDATIONS
BUT THEN IT WOULD GO BACK TO
CONGRESS. WHAT IS THE TIMING OF
THAT? SO I
>> SO THE CONGRESSIONAL
JUSTIFICATION HAS ALREADY BEEN
COMPLETED FROM OUR SIDE AND SENT
ON.
I AM NOT SURE EXACTLY WHAT THE
TIMING WILL BE FOR CONGRESSIONAL
REVIEW AND DECISION-MAKING. SEE
IF WE HAVE SOMEONE IN THE ROOM
WHO MAY HAVE MORE -- DO YOU HAVE
MORE DETAILED INFORMATION?
>> IS THAT A PUBLIC DOCUMENT?
THE CONGRESSIONAL JUSTIFICATION
FROM YOUR SIDE?
>> HOLD ON. WENDY IS GOING TO
RESPOND.
>> OKAY. THANK YOU.
>> M-HM.
>> THAT IS A PUBLIC DOCUMENT,
THAT WILL BE MADE PUBLIC WE
DON'T KNOW THE EXACT DATE, WE
EXPECT IN THE NEXT WEEK OR TWO
BUT THAT WILL BE PUBLIC. AND IT
WILL ALIGN WITH THE PRESIDENT'S
BUDGET. IN TERMS OF ANY
REORGANIZATION EFFORTS AND THE
ACTUAL APPROPRIATIONS FOR NIH
AND NIDCR, THAT IS AT THE HANDS
OF CONGRESS THEY TYPICALLY WORK
ON A TIMELINE TO DEVELOP A
BUDGET BY THE END OF THE FISCAL
YEAR WHICH IS THE END OF
SEPTEMBER SO WE EXPECT TO SEE
HEARINGS AND MORE INFORMATION
ABOUT THEIR CURRENT PROPOSALS
AND PLANS THAT THEY'RE
DEVELOPING IN THE NEXT FEW
MONTHS AND CAN KEEP AN EYE,
THAT'S ALL PUBLIC HEARINGS. SO
YOU CAN KEEP AN EYE ON THE MUSE
AND -- ON THE NEWS AND
CONGRESSIONAL HEARINGS.
WE HAVEN'T SEEN ANY DRAFT BILLS
YET.
>> THANK YOU.
>> THANK YOU DR. NOR, YOU ARE
NEXT, PLEASE.
>> THANK YOU, JENNIFER, THANK
YOU AGAIN FOR THIS EXCELLENT
REVIEW AND VERY RICH INFORMATION
THAT YOU PROVIDED TO US. ALONG
THE LINES WITH PAUL'S AND
LOUISE'S QUESTION. DO YOU HAVE
ANY INFORMATION THAT YOU CAN
SHARE ABOUT THE RATIONALE THAT
WAS USED TO MERGE THE NIDCR WITH
NEUROSCIENCE AND BRAIN RESEARCH?
THAT IS A YES THAT WE'VE BEEN
ASKED A LOT AND I FLANKLY DON'T
HAVE A GOOD ANSWER. TO THAT
QUESTION
>> NOR DO I HAVE A GOOD ANSWER
TO THAT QUESTION BUT I WILL
SHARE IS THAT THIS, THERE HAVE
BEEN CONGRESSIONAL PROPOSALS
WITH REORGANIZATION SUGGESTIONS
THAT WERE SIMILAR TO THIS. FOR
EXAMPLE, THE ROGERS PLAN THAT
WAS IN THE PUBLIC DOMAIN. LAST
FALL. YOU KNOW, WHAT IS THE
RATIONALE? I MEAN, I THINK THAT
THAT PLAN WILL GIVE YOU SOME
INSIGHTS BUT THE RATIONALE
SPECIFICALLY TO PUT THESE GROUPS
TOGETHER, I DON'T HAVE A GOOD
ANSWER FOR YOU.
>> OKAY. THANK YOU.
>> SORRY ABOUT THAT
>> IT'S ALL RIGHT.
>> THANK YOU, DR. DUE DA, YOU'RE
NEXT
>> THANK YOU SO MUCH FOR THIS
COMPREHENSIVE PRESENTATION. I
UNDERSTAND THAT COMPLYING WITH
THESE NEW POLICIES THAT YOU
SHARED WITH US HAS LED TO A LOT
OF WORK FLOW COMPLEXITY FOR
EVERYONE.
AND AS A RESULT, MANY OF THE ICS
HAVE HAD DELAYS GETTING THEIR
NOTICES OF AWARD OUT THE DOOR.
IS NIDCR ALSO SEEING THESE
DELAYS AND ARE THERE STRATEGY TO
ADDRESS IT?
>> SO THE ANSWER IS YES. THESE
DELAYS ARE ALSO BEEN, I'LL SAY,
COMPLICATED OR ASSOCIATED WITH
ADDITIONAL LEVELS OF REVIEW.
THAT HAVEN'T BEEN THERE IN THE
PAST. SO NIDCR AND OTHER
INSTITUTES ARE WORKING AS HARD
AS THEY CAN OR AS HARD AS WE CAN
TO TRY TO MOVE THINGS FORWARD AS
QUICKLY AS WE CAN GIVEN THE
CURRENT CIRCUMSTANCE. BUT SOME
OF THESE ADDITIONAL LAYERS OF
REVIEW HAVE BEEN DELAYING
THINGS. SO IT IS OUR HOPE THAT
WE CAN GET THE GRANTS AND THE
MONEY OUT THE DOOR AS QUICKLY AS
WE CAN AND WE'RE WORKING TO DO
THAT. BUT NIDCR IS NOT, WE'RE
IN THE SAME BOAT AS ALL THE
OTHER ICS WITH REGARD TO THIS.
>> THANK YOU.
>> DR. SLEP PLEASE UNMUTE
YOURSELF. ANY YES, HI, AND I
DON'T KNOW IF THERE IS PUBLICLY
AVAILABLE INFORMATION ABOUT THE
CRITERIA NOR THE ADDITIONAL
LEVELS OF REVIEW OR THE SYSTEM
FOR THE ADDITIONAL LEVELS OF
REVIEW.
I KNOW THAT'S ANOTHER AREA THAT
THERE'S A LOT OF CONFUSION AND A
LOT OF CONCERN ABOUT. A LOT OF
QUESTIONS HAVE BEEN COMING TO ME
ABOUT THAT.
>> YEAH. SO THIS IS PUBLICLY
AVAILABLE INFORMATION. I CANNOT
POINT YOU THIS MOMENT TO WHAT
THAT IS BUT PLEASE FOLLOW UP AND
THEN WHAT I THINK WE CAN DO IS
PERHAPS MUTT PUT A LINK ON OUR
WEBSITE SO THAT PEOPLE CAN SEE
IT.
>> THAT WOULD BE GREAT, THANK
YOU. TT PUT A LINK ON OUR
WEBSITE SO THAT PEOPLE CAN SEE
IT.
>> THAT WOULD BE GREAT, THANK
YOU. TT PUT A LINK ON OUR
WEBSITE SO THAT PEOPLE CAN SEE
IT.
>> THAT WOULD BE GREAT, THANK
YOU. PUT A LINK ON OUR
WEBSITE SO THAT PEOPLE CAN SEE
IT.
>> THAT WOULD BE GREAT, THANK
YOU
YOU.
>> THIS IS DR. DICKINSON, I
CAN'T GET MY PICTURE TO SHOW UP.
AM I ON?
>> YOU'RE ON.
>> A COUPLE OF MORE QUESTIONS
THAT PROBABLY ARE DIFFICULT TO
ANSWER. YOU KNOW, IF, IT
APPEARS THAT THE BUDGET WILL
STAY STABLE UNTIL '26, IS THAT
CORRECT?
>> THAT'S CORRECT.
>> LET'S ASSUME THAT IT COULD BE
POSSIBLE THAT THAT, IT WOULD BE
A REDUCTION OF THAT MONEYS,
WHICH WOULD REFLECT ON ONE OF
THE THINGS THAT REFLECT UPON IS
THE ADMINISTRATIVE COSTS AND THE
ADMINISTRATIVE PEOPLE THAT WORK
FOR PARTICULARLY NIDCR. WOULD
THAT BE A POSSIBLE REDUCTION IN
FORCE IN THAT EFFECTS THE
BUDGET? AND THEN CONSEQUENTLY
EFFECTS THE ADMINISTRATIVE PIECE
OF NIDCR?
>> SO WE HAVE UNDERGONE
SIGNIFICANT REDUCTION IN OUR
WORKFORCE. OVER 20% RIGHT NOW
WHAT HAS BEEN PROPOSED, WITH
REGARD TO REDUCTION IN BUDGET IS
A 40% REDUCTION. AND WE'LL SEE.
THIS KIND OF GOES ALONG WITH
CONGRESSIONAL OVERSIGHT OR
DECISION-MAKING. BECAUSE THAT'S
WHAT'S BEEN PROPOSED AND WHAT
WE'LL HAVE TO DO IS SEE WHAT
DECISIONS ARE MADE. WITH REGARD
TO THAT BUDGET. THAT DECREASE
BUT MANY OF THE REDUCTION
ENFORCERS HAVE ALREADY BEEN
PRETTY SIGNIFICANT. WE'RE NOT
SURE IF THERE'LL BE ADDITIONAL
CUTS BUT THIS IS WHERE WE ARE
RIGHT NOW
>> A FOLLOW-UP QUESTION, PROJECT
THAT 40%, WHO WOULD BE EFFECTED
BY THAT 40% THE RESEARCHERS?
THE GRANTS? THE FUNDING? THE
CURRENT...
>> EVERYBODY. WOULD BE AFFECTED
BY THAT 40%. IT'LL BE A VERY
DEEP CUT. THAT WOULD
SIGNIFICANTLY EFFECT THE
RESEARCH ENTERPRISE.
>> THANK YOU.
>> M-HM.
>> THANK YOU COUNCILMEMBERS FOR
THEIR QUESTIONS WOULD YOU LIKE
TO PROCEED?
>> SO I THINK WHAT WE WILL DO IS
TAKE A BREAK. TEN MINUTE BREAK
AND WE CAN RESUME AT 11:15?
>> OKAY, SOUNDS GOOD SO WE WILL
COME BACK AT 11:15.
>> RIGHT. THANKS, EVERYONE.
>> THE SCIENTIFIC ADVANCES THAT
I WILL SHARE TODAY ARE GOING TO
BE FOCUSED ON THOSE MADE IN OUR
INTRAMURAL, OKAY? OUR
INTRAMURAL PROGRAM THE
SCIENTISTS HERE AT THE NIDCR
CAMPUS CONDUCT BASIS LABORATORY
TRANSLATIONAL AND CLINICAL
RESEARCH AND PUBLIC HEALTH
RESEARCH, WHAT'S HAPPENING? AND
PUBLIC HEALTH RESEARCH IN
SUPPORT OF DENTAL, ORAL AND
CRANIOFACIAL HEALTH, OKAY? WE
USE THE LATEST TECHNIQUES, IN
BIOMEDICAL SCIENCE, LOOKING AT
THE SLIDES. YOU GOT IT? OKAY.
OKAY. GREAT. BUT BOTTOM LINE
IS, THERE'S A LOT GOING ON HERE,
THERE'S A LOT OF EXCITING
SCIENCE AND I'M SO HAPPY TO
SHARE IT WITH YOU TODAY. ACROSS
THESE THREE AREAS THAT COME
TOGETHER TO FOCUS ON ORAL HEALTH
FOR ALL FROM THE STANDPOINT OF
INTRAMURAL SCIENCE DONE HERE AT
NIDCR. AND HERE YOU'RE
LEVERAGING TECHNOLOGY TO ASK
CLINICAL QUESTIONS AND TO
DISCOVER SOLUTIONS FOR UNMET
NEEDS THIS RANGES FROM THE VERY
BASIC MOLECULAR STUDY IN
MULTIPLE AREAS AS WELL AS LARGER
PUBLIC HEALTH QUESTIONS, OKAY.
AND ALL OF THESE THINGS COME
TOGETHER AT THE CLINICAL CENTER
WHERE WE TAKE THE OPPORTUNITY TO
TRANSFORM DISCOVERIES TO HEALTH.
SO LET ME SOMEWHERE START OUT
WITH OUR CLINICAL RESEARCH IS
FORWARDING TRANSLATION, CLINICAL
INVESTIGATION AND PATIENT CARE
BRANCH BEGAN IN 1976 WITH DAVID
SCOTT AND THIS HERE HAS THE
INSIGHT TO INTEGRATE RESEARCH
AND PATIENT CARE AND THIS
HOLISTIC APPROACH REMAINS RIGHT
NOW WITH CLINICAL RESEARCH AND
PATIENT CARE OCCURRING IN THE
HOSPITAL DENTAL CLINICAL HERE AT
THE CLINICAL CENTER. SUPPORTING
PROTOCOLS FOR NCLI, FOR NIDDK
AND OTHERS AND WHAT HAPPENS HERE
IN THE WORDS OF JEN MELVIN IS
THESE OTHER INVESTIGATORS NOW
UNDERSTAND BETTER HOW THE
DISEASE THAT THEY ARE STUDYING
CAN IMPACT ORAL HEALTH. FOR
PROTOCOLS DONE AT NIDCR THERE
ARE ABOUT 25 ACTIVE PROTOCOLS
ABOUT HALF OF THEM ARE NATURAL
HISTORY AND HALF ARE
INTERVENTIONAL TRIALS THESE
CENTRALIZED CLINICAL RESEARCH
SERVICES THAT ARE PROVIDED, IT
IS REALLY ENVIABLE AND I -- WHEN
I FIRST CAME, I WAS -- IT IS
REALLY ENVIABLE TO SEE HA WHAT
THEY HAVE HERE ARE THE
CENTRALIZED SERVICES AND ALSO
INDUSTRY STANDARD REGULATION IS
OCCURRING HERE.
AND THE COLLABORATION WITH THE
OFF OF CLINICAL TRIALS
OPERATIONS AND MANAGEMENT IS
CENTRAL TO THAT. THERE'S
TRAINING, TRAINING IS CRITICAL,
FUEL TO THE ENGINE OF INNOVATION
AND RESEARCH THAT HAPPENS HERE.
SO I WILL FIRST TELL YOU A BIT
ABOUT THE CLINICAL RESEARCH
TRAINING PROGRAM. THESE ARE
POST-DOCTORAL RESEARCH TRAINING
FOR DENTISTS, THERE'S NOT A
PROGRAM LIKE THAT ANY PLACE
ELSE. WHERE THERE'S CUSTOMIZED
YEAR DEVELOPMENT AND RESEARCH
EXPERIENCE FOR THESE RESEARCH
FOCUSED DENTISTS THIS IS A 2-3
YEAR COMMITMENT AND THESE ARE
PHONES THAT HAVE AN ACTIVE
DENTAL LICENSE AND YOU SEE THEY
DO LOTS OF THINGS. BECOME
FACULTY AT MEDICAL AND DENTAL
SCHOOLS. SOME STAY HERE. SOME
GO TO OTHER GOVERNMENT ENTITIES.
VERY FUGU TO PRIVATE PLAQUE
'TIS. A FEW OF THEM LEAF THEIR
FELLOWSHIP IN ORDER TO START
THEIR OWN RESEARCH PROGRAM AND
HELP THE FIELD TO GROW.
THERE ARE MANY DIFFERENT TYPES
OF TRAINEES AND THE NIDCR OFFICE
OF TRAINING AND EDUCATION
SUPPORTS ABOUT 22 PRINCIPLE
INVESTIGATORS:
THAT TRANSLATES TO ABOUT 115
TRAINEE WHO IS ARE
UNDERGRADUATES OR JUST FINISHED
THEIR UNDERGRAD.
THEY'RE POSTBACS, POSTDOCS, YOU
HEARD ABOUT THE CLINICAL FELLOWS
BUT THERE'S ALSO DENTAL PUBLIC
HEALTH FELLOWS THAT YOU'LL HEAR
FROM LATER TODAY.
AND PEOPLE EARLIER IN THEIR
CAREER, STAFF SCIENTISTS AND
BIOLOGISTS. OKAY? SO WHEN WE
ARE GOING TO DIVE INTO THE
SCIENCE A LITTLE BIT, AND I WILL
GIVE A BIG PICTURE OVERVIEW OF
WHAT HAPPENS HERE. IN THE AREA
OF IMMUNOLOGY, INFLAMMATION AND
MICROBES, OKAY, THERE'S RESEARCH
ON MUCOSAL IMMUNOLOGY, ON
AUTOIMMUNITY AND IMMUNE
TOLERANCE ON THE MICROBES AND
THE POTENTIAL TO USE THEM AND
ALSO ON A SUBSET LINEAGE
DIFFERENTIATION AND FUNCTION.
THESE CRITICAL THINGS, THE
MICROBIOME AND MUCOSAL
IMMUNOLOGY HAD ORAL BEGINNINGS
AND THOSE WERE HERE STARTING WAY
BACK WITH THOSE WHO ISOLATED AN
ORGANISM THAT LAID THE
FOUNDATION FOR UNDERSTANDING OF
PAIR RIO. MOVING FORWARD.
NIDCR FOUNDED THE BIOFILMS
RESEARCH PROGRAM AND THIS
BLOSSOMED INTO OUR UNDERSTANDING
OF THE MICROBIOME WHICH IS NOW
IN THE COMMON VERNACULAR, OKAY?
AND WE'RE ALSO VERY EARLY
STUDIES OF INNATE MEW CROW SAL
IMMUNITY.
AND DISCOVERY OF ANTIMICROBIAL
PEPTIDES SO WHAT'S HAPPENING
NOW? THERE ARE COLLABORATIVE
STUDIES THAT OCCUR ACROSS THE
NIH FOCUSED ON PATHOGENESIS FROM
BACTERIA DEMONSTRATING THE
FLAGELLIN CAN INTERACT WITH
RECEPTORS TO RESULT IN MUCOSAL
PATHOLOGIES ON INTERACTION WITH
VIRUSES AND HOW THESE VIRUSES
JUST RAN RAMPANT IN THE CONTEXT
OF THE DOC 8 DEFICIENCY SO
HELPING UNDERSTAND UNDERSTAND
ABOUT THE PATHOGENESIS AND
FINALLY BARRIER DEFECTS AND WHAT
IS HAPPENING AT THAT HOST
PATHOGEN INTERFACE ADDITIONALLY
THESE STUDIES HELP US LEARN
ABOUT ORAL, SKIN AND WOUND
HEALING AND ALSO THE ROLE OF,
INTERFERONS IN AUTOIMMUNE
ILLNESSES. THIS IS ALSO, THE
WORK HAS HELPED US SHIFT THE
MINDSET AROUND PERIODONTAL
DISEASE THAT IS ONLY A BACTERIAL
DRIVEN INFLAMMATORY CONDITION.
WE NOW KNOW BASED ON THE WORK
THAT'S BEEN DONE THAT THERE ARE
CELLULAR DEFECTS THAT CAN MAKE A
HUGE DIFFERENCE. OKAY? AND IN
THE CONTEXT OF IMMUNO
PATHOLOGIES, JUST THOSE DEFECTS
CAN RESULT IN PERIODONTAL
DISEASE AND BONE LOSS LIKEWISE,
INACTIVATION OR DIS-REGULATION
OF A CELL CAN DRIVE THE
NEUTROPHIL CHEMO ATTRACTION
MECHANISM TO HELP PUSH PERRY OWE
DONNAL DISEASE.
WHAT ABOUT PAIN? THIS IS
UNDERSTANDING THE MECHANISMS OF
DIFFERENT SENSATION THAT
INCLUDES TASTE, SE MAT TO
SENSATION AND PAIN WHICH THIS IS
TOUCH, PRESSURE AND TEMPERATURE.
AND TAKING THIS INFORMATION TO
DEVELOP AND TEST NOVEL
THERAPEUTICS TO COMBAT PAIN.
THERE IS A RICH HISTORY OF PAIN
RESEARCH HERE AT NIDCR. WITH
THE DISCOVERY OF THE GENETIC
BASIS OF PAIN, THE RECOGNITION
OF THE ACUTE TO CHRONIC PAIN
TRANSITION, THE SIXTH VITAL SIGN
NOW IS PAIN AND THE OBJECTIVE
MEASUREMENT OF PAIN. THIS
SCALES WERE DEVELOPED HERE AT
NIDCR. AND ALSO THE RECOGNITION
OF THE IMPORTANCE OF
MULTIDISCIPLINARY PAIN RESEARCH,
SPEARHEADED BY RON IN 1983 SO
WHAT IS HAPPENING NOW? THERE'S
SIGNIFICANT WORK UNDERSTANDING
PAIN AND SOMAT TO SENSATION
LOOKING AT WHAT HAPPENS AT THE
PERIPHERY, HOW THESE DISEASE AND
INFLAMMATION CAN INFLUENCE SOMAT
TO SENSATION TO RESULT IN PAIN
AND UNDERSTAND THIS AT MULTIPLE
LEVELS.
FIRST WHAT ARE THE CELLULAR
MOLECULAR CHANGES THAT IMPACT
THE PATHWAYS THAT OCCUR IN THE
GANGLIA, IN THE PERIPHERAL, IN
THE TRY GEM THAT NERVE AND THEN
WHAT IS HAPPENING IN THE BRAIN?
THERE ARE AREAS IN THE BRAIN
THAT ARE RESPONDING TO PAIN IN
DIFFERENT NUCLEI THROUGH
DIFFERENT SETTINGS IN RESPONSE
TO TOUCH, TEMPERATURE,
PROPRIOCEPTION AND NO SEW
SESSION THERE'S ALSO STUDIES
ONGOING TO UNDERSTAND HOW THE
IMMUNE SYSTEM CAN REGULATE PAIN
AND DETAILED MULTIOHMIC ANALYSIS
OF DORSAL ROOTS AND TROOI
GEMINAL GANGLIA TO UNDERSTAND
PAIN, AND EVEN ORAL FACIAL PAIN.
THE RECENT WORK PROVIDES NEW
TARGETS FOR COMBATTING PAIN.
AND HELPS US UNDERSTAND WHY
TOUCH BECOMES PAINFUL DURING
INFLAMMATION? HELPS US
UNDERSTAND SOUND CIRCUITS AND
HOW THEY CAN FACILITATE MOVEMENT
TOWARDS ANALGESIA AND FINALLY
IDENTIFYING BRAIN CENTERS THAT
CAN POWERFULLY CONTROL ASPECTS
OF PAIN. OKAY? THERE ARE ALSO
CURRENT STUDIES ONGOING IN TMD
AND PAIN THROUGH THE INTRAMURAL
HEAL INITIATIVE. WHAT ABOUT
EPITHELIAL AND SALIVARY GLAND
BIOLOGY AND DYSFUNCTION THE
FOCUS HERE IS TO UNDERSTAND
CELLULAR, MOLECULAR AND GENETIC
MECHANISMS THAT UNDERLIE
DEVELOPMENT, DIFFERENCE RATION
AND SECRETORY PHYSIOLOGY. WHAT
IS THE GOAL? TO REPAIR AND
REGENERATE NEW FUNCTION AND YOU
HEAR MORE ABOUT THAT LATER ON.
WE LOOK AT FUNDAMENTAL BIOLOGY.
JUST CHANGING FUNCTIONS LIKE
CELL ADHESION CAN REENGINEER
CELLS TO UNDERGO BUD IDING
GENESIS. WE LEARN ABOUT
FUNDAMENTAL BIOLOGY
UNDERSTANDING THE ROLE OF DMRIE
COSLATION IN DEVELOPMENT AND
DISEASE IS SOMETHING HAPPENING
HERE WHERE GLYCOSYLATION IN
DEVELOPMENT AND FUNCTION, AND
THAT THESE ENZYMES USE DIVERSE
SUBSTRATE RECOGNITION MODES TO
REGULATE CELL FUNCTION AND
IMMUNITY THIS EFFECTS SECRETION,
IT EFFECTS SECRETORY MATURATION
AND ALSO THE STABILITY OF THE
MICROBIOME BECAUSE THERE'S A
MIMICRY THAT OCCURS AND YOU CAN
SEE AT THE BOTTOM THERE THAT THE
MICRO DRIVEN MUTATION, THE
ENZYME, LOOKS VERY MUCH LIKE
THIS ONE AND IN THE CONTEXT OF
THE MICROBIOME THAT BUGS LIKE
KNEW COLLIE YACHT TOM CAN
UTILIZE THESE ENZYMES IN THE
CONTEXT OF THE XO POLYSACCHARIDE
MODULATE THE BIOFILM.
SO THESE, THIS GLYCOSYLATION
WHICH WE DIDN'T UNDERSTAND VERY
WELL HAS SIGNIFICANT ROLES IN
MULTIPLE FUNDAMENTAL PROCESSES.
WHAT ARE WE DOING TO TRANSLATE
FUNDAMENTAL SCIENCE? WELL,
WE'RE UNDERSTANDING THE
MOLECULAR BASIS OF SALIVARY
GLAND FUNCTION AND DYSFUNCTION,
AND WORKING TO FOCUS ON DISEASES
LIKE SHOW AGAIN'S SYNDROME TO
DEVELOP STRATEGIES ONE IS INVIVO
GENERATED T REG BUT YOU'LL HEAR
MORE ABOUT THAT UTILIZING THE
UNDERPINNINGS BY BLAKE WARNER IN
A FEW MINUTES. YOU'LL ALSO HEAR
ABOUT SKELETAL BIOLOGY. HERE
THIS FOCUSES ON DEVELOPMENT AND
MAINTENANCE OF SKELETAL ISSUES
THAT INCLUDE TEETH, BONE AND
CARTILAGE, WITH A REAL EMPHASIS
ON MATRIX ASSOCIATED IN
MACROMOLECULES AND PROTEASES AND
YOU'LL HEAR ABOUT THAT FROM
DR. ROSCOE AND TEAM. YOU'LL
ALSO HEAR ABOUT MECHANISMS OF
CELL FATE AND DEVELOPMENT. AND
THE WORK HERE EXPLORES
FUNDAMENTAL QUESTIONS RELATED TO
TISSUE MORPHOGENESIS TO CELLULAR
FUNCTION TO DIFFERENTIATION AND
CANCER AND ALSO CRANIOFACIAL
DEVELOPMENT WITH A GOAL OF
PREVENTING AND TREATING THESE
DISORDERS AND YOU'LL HEAR ABOUT
THIS FROM AKEEM WESTERN
WESTERNER. OKAY? AND FINALLY
PUBLIC HEALTH RESEARCH AT NIDCR.
THIS IS ACTUALLY HOW THIS
INSTITUTE BEGAN WITH FLUORIDE
RESEARCH. SPURRED BY TRENDILY
DEAN IN A SIGNIFICANT EXPERIMENT
A FIFTEEN YEAR STUDY IN GRAND
RAPIDS, MICHIGAN THIS LONG-TERM,
SCHOOL BASED PROGRAM REALLY
BECAME THE BASIS FOR ONE OF THE
MOST SUCCESSFUL PUBLIC HEALTH
EFFORTS IN DENTISTY. WATER
FLUORIDATION, DEAN BECAME A
FIRST DIRECTOR OF THE INSTITUTE
AND HIS FOCUS WAS ON INTRAMURAL
RESEARCH AND ALSO TRAINING OTHER
PUBLIC HEALTH EFFORTS WITHIN W
THE NATIONAL CARRY'S PROGRAM,
THE NATIONAL SURVEY OF ADULT
DENTAL HEALTH AND YOU'LL HEAR
ABOUT THAT FROM DR. AL RAH GOING
SO IT IS MY PLEASURE TO NOW
SHARE WITH YOU, YOU'LL HEAR FROM
OUR SCIENTISTS HERE.
AND WHEN I THINK IS A GREAT MANY
SYMPOSIUM OF THE DIFFERENCE THAT
INTRAMURAL RESEARCH IS MAKING IN
THE WORLD BECAUSE OF THE
OPPORTUNITIES HERE TO LEVERAGE
THINGS THAT DON'T EXIST
ELSEWHERE. SO WE'LL HEAR FROM
DR. WARNER ON SHOW AGAIN'S
SYNDROME AND SERE OWE STOEM YA.
>> THANK YOU FOR THAT WARM
INTRODUCTION AND THANK YOU TO
NIDCR COUNCIL FOR GIVING THE
DIVISION OF INTRAMURAL RESEARCH
THE OPPORTUNITY TO SPEAK TODAY.
MY NAME IS BLAKE WARNER TODAY I
WILL TALK ABOUT SHAPING THE
FUTURE OF SALIVARY GLAND
BIOLOGY, TRANSLATIONAL
BREAKTHROUGHS FROM THE NIDCR
IDP. THE AREA OF FOCUS I WILL
BE SPEAKING ON IS ON THE EP
THEME V -- EPITHELIAL BIOLOGY
WHICH INCLUDES ALL THESE FOLKS
HERE AND MYSELF, BLAKE WARNER,
NIDCR'S MISSION HAS BEEN FOR
MORE THAN 40 YEARS, HAS BEEN
MISSION FOCUSED ON UNDERSTANDING
MECHANISMS AND DEVELOPING
THERAPIES FOR ZERO STOEM YA,
SHOW AGAIN'S DISEASE AND BEYOND.
THIS HAS REQUIRED LONG-TERM
VISION AND DEDICATION
INVESTIGATING THE CONTINUUM FROM
BASIC PHYSIOLOGY THROUGH
CLINICAL RESEARCH. ONE MIGHT
STATE THAT 0 WROTE STOEM YA OR
DRY MOUTH IS ALL THE SAME BUT I
THINK IT'S IMPORTANT TO
DELINEATE THAT INSULTS TO INJURY
TO THE SALIVARY COMPLEX WHILE
HAVING DOWNSTREAM EFFECTS ON
ORAL TISSUES SUCH AS IN THE
TEETH CAN LEAD TO CHANGES IN
FUNCTION AND CHANGES IN QUALITY
OF LIFE IS THAT THEY HAVE UNIQUE
PATH PHYSIOLOGIC PROCESSES AND
CAN BE CLASSIFIED BASED ON THE
TYPE. ONE OF THE MORE COMMON OR
AUTOIMMUNE OR AUTOINFLAMMATORY
DISEASES SHOW GLEN'S DISEASE AND
CHRONIC GRAFT VERSUS HOST WILL
BE BY MY COLLEAGUE. AND I WILL
SPEAK ABOUT IYAT ROW GENERALIC
INJURY, WE CALL THIS RADIATION
INDUCED SERE ROW STOEM YA WHILE
THERE ARE OTHER TYPES OF
DISORDERS THAT HAVE SALIVARY
GLAND DYSFUNCTION AS A CORE
COMPONENT OF THAT PATHOLOGY, I
WILL NOT BE SPEAKING OF THOSE
TODAY. TO UNDERSTAND PATHOLOGY
OF THE SALIVARY GLANDS IT'S
REALLY CRITICAL TO UNDERSTAND
THE BASIC PHYSIOLOGY OF
SECRETION, I'M LUCKY ENOUGH TO
STAND HERE TODAY TO TALK ABOUT
SHOW AGAIN'S DISEASE BECAUSE OF
PIONEERING EFFORTS BY THE
RESEARCH PROGRAM.
AND THE CONTINUING EFFORTS OF
THOSE THAT STUDY THE ROLE OF MY
TO CON THREE Y'ALL FUNCTIONS.
AND A DOCTOR THAT STUDIES
BICARBONATE AND ALSO THE
EXOCRINE FUNCTION IN THE
PANCREAS AND THE SALIVARY
PROCESS. AND PROTEIN
MODIFICATION AND PROTEIN
SECRETION AND NADINE WHO STUDIES
DMRIE COSLATION OR POST
TRANSLATIONAL. AND THEIR ROLE
IN MUCOSAL INNATE IMMUNITY AND
WHILE I'M NOT DISCUSSING MANY
OTHER PIONEERS IN THIS, IT ALL
BOILS DOWN TO THE FUNCTIONAL
UNIT OF THE EXOCRINE COMBLANDZ
THIS IS THE CELLS IN THE
CONNECTION TO THE DICTS THAT
TRANSIT TO THE ORAL CAVITY TO
DELIVER SALIVA.
ON THE OTHER SIDE OF THIS
EQUATION IS THE SHOW AGAIN'S
CLINIC. OVER 40 YEARS AGO THE
FIRST PROTOCOLS IN SHOW AGAIN'S
DISEASE WERE INITIATED THESE
CLINICAL INVESTIGATIONS WERE
LARGELY LONGITUDINAL STUDIES OR
OBSERVATIONAL STUDY TO
CHARACTERIZE SALIVARY GLAND
DISEASES. BUT THE, ALONG THE
WAY THERE WERE ALSO
INTERVENTIONAL STUDIES HERE I
LABELED THE SAFETY OF SHOW
AGAIN'S DISEASE WHERE YOU CAN
LUMP IN THE EARLY STUDIES
SHOWING THE PILOCARPINE WAS AN
EFFECTIVE WAY TO INCREASE FLUID
SECRETION IN DRY MOUTH
CONDITIONS. THIS ALSO SERVES AS
A WAY TO COMPREHENSIVELY
CLINICAL PHENOTYPE PATIENTS,
COLLECT TISSUE SAMPLES AND OTHER
BIOFLUIDS AND BRING THEM BACK TO
THE LAB WHERE BASIC AND
TRANSLATIONAL INVESTIGATIONS CAN
HAPPEN IN A BEDSIDE TO BENCH
APPROACH. BUT ALSO TO TAKE
THOSE THINGS WE LEARN AT THE
BENCH AND TRANSLATE THEM BACK
INTO THE CLINIC AND SO THIS IS
WHERE I CAME TO NIDCR, I WANTED
TO UNDERSTAND AND IN FACT TREAT
SHOW AGAIN'S DISEASE. AND TO DO
THAT I WANTED TO INVESTIGATE THE
IMMUNO PATHOLOGY OF SHOW AGAIN'S
DISEASE TO IDENTIFY THE THERAPY
IN HUMANS.
THERE'S TWO BENCH TO BID SIDE
VIGNETTES THAT THAT ARE FROM OUR
FOCUS AREA.
THE FIRST IS FROM DR. SAR CAR
WHO UNFORTUNATELY IS NOT ABLE TO
BE HERE WITH US TODAY AND HER
PRESENTATION WILL BE GIVEN BY
HER MENTOR.
WHO WILL BE PRESENTING CORRECTOR
RESTORES FUNCTION IN
EXPERIMENTAL SHOW AGAIN'S
DISEASE AND MY COLLEAGUE AND
SCHOLAR DR. JACKIE MAYES WHO
WILL DISCUSS HOST DISEASE IN AN
INDIVIDUAL WITH VEK SIS
SYNDROME.
SO FIRST, I WANT TO TAKE A STEP
BACK IN TIME AND TALK ABOUT
RADIATION AFFECTED SALIVARY
GLANDS. RADIATION OR EXTERNAL
BEAM REDUATION, PREFERENTIALLY
DAMAGES THE CELLS SENSITIVE TO
THE DOUBLE STRAND BREAKS BY BEAM
RADIATION THIS LEADS TO A LOSS
OF FUNCTIONAL WHAT RAN KA MA, A
DECREASE IN THE PROTEINS.
HOWEVER ONE OF THE EARLY
PIONEERS IN SALIVARY DISFUNCTION
RESEARCH WAS DR. BRUCE BAUM WHO
HYPOTHESIZED THAT YOU COULD
REENGINEER THE EPITHELIUM
UNAFFECTED BY BEAM REDUATION TO
INCREASE FLUID PERMEABILITY IN
THAT LAYER AND AUGMENT FUNCTION.
AND THROUGH A LONG-TERM VISION
AND MANY IN VITRO AND IN VIVO
LARGE AND SMALL ANIMAL MODELS
SHOWED PRECLINICAL EFFICACY AND
THEN WITH A FIRST IN HUMAN
CLINICAL TRIAL SHOWED THATTED A
DEKNOW VIRUS DELIVERED TO THE A
SINGLE GLAND OF PATIENTS COULD
RESTORE SALIVA FLOW. HOWEVER
THIS TREATMENT WAS DOSE LIMITED
AND HAD A VERY SHORT LIFE SPAN
THIS LED TO AN OPPORTUNITY TO
CHANGE THE HYPOTHESIS OR CHANGE
THE APPROACH.
AND DR. BRUCE BAUM RECRUITED
DR. JAY WHO WAS AN EXPERT IN AD
KNOW ASSOCIATED BIOLOGY. JAY IS
NOW SENIOR INVESTIGATOR AND
ACTING SCIENTIFIC DIRECTOR OF
THE INTRAMURAL PROGRAM. AAV 2
WHICH IS A LOW VECTOR IN FACT WE
HYPOTHESIZED WE COULD DELIVER TO
THE SALIVARY EPITHELIUM IN CELLS
AND DUCT TO RESTORE FUNCTION
LONG-TERM AND AGAIN THROUGH A
LONG-TERM VISION IN VITRO, IN
VIVO MODELS INCLUDING SMALL AND
LARGE ANIMAL MODELS WAS ABLE TO
DEMONSTRATE EFFICACY IN EARLY
FIRST IN HUMAN CLINICAL TRIALS
OF AV 2 FOR THE TREATMENT OF
RADIATION INDUCED XEROSTOMIA I
ALWAYS THINK A PICTURE IS WORTH
A THOUSAND WORDS BUT IN THIS
CASE THOSE CLINICAL PHOTOS CAN
SHOW THAT NOT ONLY DID FLUID
SECRETION INCREASE BUT YOU HAVE
RESTORATION OF THOSE ORAL
TISSUES AS YOU CAN SEE THE SIDE
BY SIDE OF THIS DAY 56 PHOTO OF
A PATIENT FROM THE CLINICAL
TRIAL. THIS STUDY REPRESENTS A
PRIVATE PUBLIC PARTNERSHIP WITH
GTX WHERE THEY CAN SUPPORT THE
CONTINUATION OF THESE TYPES OF
STUDIES. BUT BEYOND JUST
RESTORING SALIVARY FLOW, THE
TECHNOLOGY DEVELOPED AT NIDCR
AND THIS IS IN FACT A RECURRING
THEME HAS FAR REACHING EFFECTS
ACROSS THE SPECTRUM OF WHAT WE,
OF HUMAN INTERVENTIONS. AND IN
THIS CASE, AD DEKNOW SERE ROW
TYPE 5 FIRST ASSOCIATED BY THIS
DOCTOR IS NOW THAT MOLECULAR
TRUCK OR THAT VECTOR USED IN TWO
FDA APPROVED GENE THERAPIES.
ROCK TAIF YAN APPROVED IN 2023
AND HEM GENERALICS APPROVED IN
2022.
FOR HEMOPHILIA A AND HEMOPHILIA
B. THERE ARE NOW SEVERAL OTHER
INDICATION THERE'S THE APPROVAL
PIPELINE AND YOU'LL CONTINUE TO
SEE THESE VECTORS WHICH ARE SAFE
AND LOW IMMUNOGENICITY USED IN
THESE THERAPIESLY TALK ABOUT THE
DISEASE I'M FOCUSED ON, SHOW
AGAIN'S DISEASE THIS REPRESENTS
ONE OF THOSE MAJOR UNMET MEDICAL
NEEDS.
A DISTINCT CHRONIC SYSTEMIC
AUTOIMMUNE DISEASES EFFECTS
BETWEEN 2-4 MILLION AMERICANS IN
THE UNITED STATES. IT HAS A
STRIKING 9-1 FEMALE PREDILECTION
AND DIAGNOSED TYPICALLY OTHER
THE AGE OF 40 YEARS. CONFERS A
20-40 FOLD RISK OF LYMPHOMA AND
THE HIGHEST RISK AMONG THE
AUTOIMMUNE DISEASES. SOME
PATIENTS ALSO HAVE SYSTEMIC
INVOLVEMENT OF THE LUNGS, THE
KIDNEYS THE JOINTS AND THE SKIN
AND UNFORTUNATELY THERE ARE NO
YET APPROVED TREATMENTS OR CURES
FOR SHOW DREN'S DISEASE. IN
FACT, THIS IS NOT DUE TO EFFORT.
WE HAVE HAD MANY TRIALS IN SHOW
AGAIN'S DISEASE WITH MANY
FAILURES INCLUDING SOME VERY
INSIGHTFUL CLINICAL TRIALS
CONDUCTED HERE AT THE NIDCR.
FOR I HAVE IF A LIZ MAB,
ANTI-LFA 1. BUT WHAT WE LEARN
FROM THESE TRIAL IS WE HAD A GAP
IN UNDERSTANDING THE FUNDAMENTAL
SHOW AGAIN'S PATHOLOGY, WE
IDENTIFIED THAT PATIENTS HAD
EXTREME HETEROGENEITY AND SOME
OF THE REASONS THAT THESE TRIALS
FAILED THAT WE HAD POOR OUTCOME
MEASURES AND POOR TRIAL DESIGN.
BUT TECHNOLOGICAL ADVANCES HELP
UNWRAP THE PATHOGENESIS OF SHOW
AGAIN'S, AND IN THE 2000S THE
TRANSCRIPTOMICS HELPED TO
IDENTIFY THOSE CORE PATHWAYS AND
GENES THAT WERE DIFFERENTIALLY
REGULATED IN SHOW AGAIN'S
DISEASE AND THIS TOLD US THAT
SHOW AGAIN'S WAS RELATED TO AN
INFILTRATION OF T AND B CELLS
AND WAS REPRESENTED BY AN
UPREGULATION OF CLASS ONE AND
TWO, DIS-REGULATION OF
INTERFERONS AND INTERFERON
STIMULATED GENES AND THE
REGULATION OF IMMUNO DMGLOBULIN
EVEN THOUGH WE LEARNED A LOT
ABOUT THIS AUTOIMMUNE DISEASE
AND WE KNOW WE CAN ACCESS THAT
TARGET TISSUE, WE TOOK THIS
AFFECTED TISSUE AND WANTED TO
DRILL DOWN INTO WHAT WERE THE
CORE PATHWAYS THAT COULD BE
TARGETED FOR NEAR TERM
STRATEGIES TO TREAT SHOW AGAIN'S
DISEASE WITH THE IDEA THAT IF
WE'RE ABLE TO CORRECT THOSE
DYSREGULATED PATHWAYS WE COULD
BOTH RESTORE FUNCTION, AND
PERMIT REGEN RATION OF THAT
ORGAN. TO OPEN THIS DOOR WE
USED BULK RNA SEQUENCING TO LOOK
AT THE CORE PATHWAYS IN GENES
THAT WERE DISREGULATED AND ONE
OF THE TOP PATHWAYS WAS THE
JAK-STAT PATHWAY AND SHOWING A
HUB THAT WAS UPREGULATED AND NOT
FOUND AT ALL IN HEALTHY
VOLUNTEERS. FURTHER LEVERAGING
TECHNOLOGIES SUCH AS SINGLE CELL
AND SPATIAL TRANSCRIPTOMICS
SHOWING HERE SINGLE CELL
TRANSCRIPTOMICS WE CAN IDENTIFY
THE TARGET AND EFFECTOR CELLS
AND WHAT THIS TOLD US WAS THAT
THE MOST EXPANDED CELL TYPE
FOUND WERE THE CELLS WITH AN
EXHAUSTED PHENOTYPE BUT THE MOST
LOST CELL TYPE WERE THE CELLS
THAT SECRETE A SPECIFIC
PORTFOLIO OF PROTEINS AND
FLUIDS. WHEN WE USE THE SINGLE
CELL RNA SEQUENCING AND WE DO
BIOINFORMATIC ANALYSES WE CAN
USE RECEPTOR LIGAND ANALYSIS AND
HERE SHOWING THE PATHWAY THAT
THESE CELLS TARGET DIRECTLY
THOSE MUCUS AND DUCTAL
EPITHELIA. AND DUE TO THE
GENEROSITY AND THE FORESIGHT OF
DR. JAY WE HAD EARLY ACCESS TO
THE SPATIAL TRANSCRIPTOMIC
PLATFORM AND HERE SHOWING THE
SPATIAL TRANSCRIPT TOMIC STUDY
OF A TISSUE MICROARRAY THAT
REPRESENTS 22 PATIENTS.
WE CAN SHOW THAT THOSE SIERRA
MUCUS CELLS ARE IN FACT ENGAGED
BY THAT EFFECTOR T-CELL. THIS
LEVERAGES DATA IN USING CELL TO
THE PIPELINE SIMILAR TO THE
LIGAND EXCEPT IT IDENTIFIES
POTENTIAL DRUGS OR POTENTIAL
SIDE EFFECTS OF DRUGS. AND SO
USING OUR TMA AND SPATIAL
TRANSCRIPTOMICS WE CAN ACTUALLY
SHOW THAT ONE OF THE DRUGS THAT
MIGHT BE USEFUL IN SHOW AGAIN'S
DISEASE WERE IN FACT TOFACITINIB
THAT HIGHLIGHTS THESE
INFILTRATES IN A PERRY DUCTAL
PATTERN AND THIS BEING THAT
T-CELL INFILTRATED NEIGHBORHOOD
WHAT WAS REALLY INTERESTING WAS
NOT ONLY WAS THE -- WAS
TOFACITINIB MARKETING THOSE
CELLS BUT ALSO MARKING THOSE
T-CELL ENGAGED EPITHELIAL CELLS
AND THIS DRUG MAY IN FACT HIT
BOTH SIDES OF THAT AND DUE TO
THAT FACT --
>> FIVE MORE MINUTES TO GO.
>> -- A RANDOMIZED TRIAL TO
IMPACT SIGNALLING SO TAKING THE
BEFORE DRUG AND OVER A SIX MONTH
PERIOD OF TREATMENT. WE COLLECT
SALIVARY FLOW RATES, WE COLLECT
WHOLE BLOOD. WE HOPEFULLY WOULD
BE ABLE TO SHOW A RESTORED GLAND
INCLUDING RESTORED FUNCTION.
AND IN THE TWELVE PATIENTS IN
THE INTENT TO TREAT GROUP THERE
WERE NO LIFE-THREATENING AES,
PATIENTS REPORTED LESS FATIGUE
AND OBJECTIVELY MORE SALIVA AND
SOME HAD REDUCED DISEASE
ACTIVITY AND INFLAMMATION IN THE
GLANDS AND JUST TO SHOW THIS AND
I WILL TALK ABOUT THE GRAPH ON
THE RIGHT YOU CAN SEE THE
DISEASE ACTIVITY OR THE SCORE AT
FS THAT FIVE OUT OF THE EIGHT
PATIENTS WHO RECEIVE DRUG HAD
OBJECTIVE IMPROVEMENTS. THIS
LEADS TO OUR CURRENT AND FUTURE
DIRECTIONS, THAT WE HAVE
IDENTIFIED MULTIPLE THERAPEUTIC
APPROACHES TO TREAT SHOW AGAIN'S
AS WELL I DIDN'T TALK ABOUT THIS
TODAY THAT JAK INHIBITORS MAY
BLOCK INTERFERENCE SIGNALLING
THAT THERE ARE OTHER PATHWAYS
THAT THIS, THESE TYPES OF
STUDIES ILLUMINATED. THANK YOU.
BEFORE I JUMP OFF I WANT TO
INTRODUCE THE NEXT SPEAKER
DR. JOEL
>> THE DOCTOR SHOULD BE SHARING
HIS OWN PRESENTATION. YEP. IS
THE DOCTOR ONLINE.
>> HELLO. I THINK I WILL BE
PRESENTING. CAN YOU HEAR ME?
>> OKAY. IS THIS THE DOCTOR?
>> YEAH.
>> OKAY. GO AHEAD, PLEASE.
>> SO LET ME...
ABOUT MORNING EVERYBODY.
WE'RE IN THE TRANSPORT SECTION.
I'M GOING TO TALK ABOUT HOW
THERE'S A FUNCTION THAT REPAIRS
THE GLAND AND FUNCTION.
SO SJOGREN'S DISEASE IS
ASSOCIATED WITH REDUCED SALIVARY
FUNCTION AND WE ASK THE QUESTION
IF THE EXPRESSION IS REDUCED AND
ALTERED IN MODELS OF SJOGREN'S
DISEASE AND IF WE CAN IMPROVE
THE FUNCTION.
FOR THE STUDY WE USED TWO MOUSE
MODELS IN COLLABORATION AND
TRANSDUCED THE MICE TO DEVELOP
THE SJOGREN'S SYNDROME.
SO OUR WESTERN BLOT AND
LOCALIZATION STUDY SHOWS THERE'S
A MARK REDUCTION IN THE PROTEINS
AND WE LOOKED AT THE LUMINAL
MEMBRANE AND THERE'S A LACK OF
CFTR IN BOTH LOCALIZATION AND
EXPRESSION AND WITH THE
CORRECTOR IS USED CLINICALLY TO
TREAT THE CYSTIC FIBROSIS
PATIENTS SHOWED MARK EXPRESSION
IN EXPRESSION AND LOCALIZATION
BACK TO THE DUCTS.
SO WE TRIED TO FIND THE DUCTS
FROM THE MICE AND TREATED WITH
C18 AND THE DUCTS ARE USED TO
MEASURE THE FLUID SECRETION IN
THE HUMAN LUMEN.
THE TREATMENT PARTIALLY RESTORED
THE DUCTAL SECRETION AND IT'S
MEDIATED WE MEASURED THE
SALVATION IN THE MICE IF IT'S
REPAIRING THE DUCTS AND GLANDS
AND FUNCTION.
THE MICE WERE TREATED AND TO OUR
SURPRISE NOT ONLY THE FLUID
SECRETION WAS SIGNIFICANTLY
RECOVERED BUT ALSO THE CELLS
WERE RESTORED SO IN OUR
CONCLUSION, THE TREATMENT WAS
PROMISING IN THE TREATMENT OF
SJOGREN'S DISEASE.
>> THANK YOU.
>> THANK YOU SO MUCH.
WE'LL NOW MOVE TO CLINICALLY
SESSION TWO ON CELLULAR AND
MATRIX BIOLOGY.
DR. KELLY VIGNETTE
TO FOLLOW FOLLOWED BY
DR. CONSTANTINA.
>> GREAT. THANK YOU. SO TODAY
I'LL TELL YOU ABOUT SOME OF THE
WORK FROM THESE FIVE PIS WHO
STUDY SKELETAL MATRIX AND
MECHANOBIOLOGY HERE AT THE
NIDCR. SO THE LONG HISTORY OF
DISCOVERY AND THE FIELD OF
SKELETAL AND MATRIX RESEARCH AT
THE NIDCR BEGAN WITH DR. DAVID
SCOTT FORMER DIRECTOR OF THE
NIDCR AND DR. MA ROOE WHO
STUDIED MINERALIZED TISSUE USING
THE TECHNIQUE OF MICROSCOPY.
THIS CONTINUED WITH DR. PEE YEZ
AND MARTIN WORKING ON COLLAGENS,
VINCE HAS CALENDAR, AND HARRY
WORKED ON BMP. THEN JOHN
DEVELOPED METHODS FOR ISOLATED
BONE PROTEINS WITHOUT ENZYMATIC
DIGESTION AND PUT TOGETHER A
TEAM CONSISTING OF DR. AVA WHO
STUDIED BONE MARROW, LARRY
FISHER WHO CHARACTER IDEAS THE
PROTEINS, PAM WHO ISOLATED THE
CELLS, MARY ANN YOUNG WHO
STUDIED THE GENES AND MIKE COLIN
WHO IS TRANSLATED ALL THIS WORK
INTO PATIENTS WITH DISORDERS OF
BONE AND MARROW HOMEOSTASIS.
SORRY, CAN YOU SEE MY SCREEN?
THERE'S THIS TEAMS THING IN THE
WAY.
>> YES.
>> OKAY. THANK YOU. SO OUR
GOAL IS TO INVESTIGATE SKELETAL
ISSUES THAT INCLUDE CARTILAGE,
BONES AND TEETH AS WELL AS BONE
MARROW, TENDONS AND LIGAMENT
WHICH IS ARE IMPORTANT AS THEY
COMPRISE THE DENTAL, ORAL,
CRANIOFACIAL COMPLEX AND WE AIM
TO REDUCE CHRONIC DISEASES BY
APPLYING CLINICAL RESEARCH TO
GAIN INSIGHT INTO
PATHOPHYSIOLOGIC AND DEVELOPMENT
MECHANISMS SO OUR APPROACH IS
WITH MODEL SUCH AS STEM CELLS,
AND COMPUTATIONAL ANALYSES AND
WE HAVE SHOWN ACROSS MANY
DISORDERS OUR ABILITY TO
TRANSLATE THE PRINCIPLES WE FIND
DIRECTLY TO PATIENT CARE THROUGH
CLINICAL TRIALS THAT IMPROVE
PROGNOSIS AND TREATMENT OF
SEVERAL DISORDERS. SO THE
GROUP'S ACTIVITIES ENCOMPASS A
BROAD SPECTRUM OF COLLABORATIVE
STUDIES WITHIN SKELETAL AND
CRANIOFACIAL BIOLOGY. WE
TRANSLATE WORK ON FUNDAMENTAL
CELL TYPES AND HORMONES INTO
SEVERAL PATIENT COHORTS OF RARE
DISEASES WHICH CAN THEN INFORM
MUCH MORE COMMON DISEASES. AND
THE USE OF RARE DISEASES TO GAIN
INSIGHTS INTO COMMON DISEASES IS
A STRATEGIC DECISION AS THESE
RARE DISEASES ARE OFTEN MONO
GENERALIC AND THEREFORE THEY
HAVE FEWER COMPOUNDING VARIABLES
THAN CHRONIC CONDITIONS DO. FOR
INSTANCE, STUDYING HYPO FOZ FOE
TEAM YA ELIMINATES THE VARIABLES
OF STUDYING IN CHRONIC KIDNEY
DISEASES WHERE THOSE PATIENTS
HAVE COMORBID CONDITIONS SUCH AS
HYPERTENSION SO THIS ALLOWS A
CLEARER RESULT IN INTERPRETING A
CLINICAL TRIAL. AN EXAMPLE OF
THIS IS THE RARE DISEASE
SYNDROME AND THIS IS STUDIED.
THIS PATIENT HERE DEMONSTRATES
THE CHARACTERISTIC FEATURES
INCLUDING THIS EYES, LOW SET
EARS, ALL OF WHICH ARE
CONSISTENT WITH A CRANIAL BASE
ABNORMALITY AND PATH MNEMONIC
FOR THIS CONDITION. SO THIS
SYNDROME IS A DISORDER OF TGF
BETA SIGNALLING AND CAUSE THIS
IS PATHOLOGY, ENAMEL DEFECTS AS
SEEN HERE AND AORTIC ANEURYSMS
THAT CAN BE FATAL SO THEY USE
THIS MODEL DISEASE TO STUDY
CRANIOFACIAL ANOMALIES AS WELL
AS TMJ DISORDER THAT CAN BE
TRANSLATED TO THE GENERAL
POPULATION WHO SUFFER FROM TMJ,
AND FROM DENTAL CARIES.
ADDITIONALLY, THE USE OF THE NIH
CLINICAL CENTER TO STUDY RARE
DISEASES IS A GOOD USE OF
RESOURCES SINCE PATIENTS FROM
ALL OVER THE COUNTRY CAN COME
TOGETHER HERE AT THE NIH
ENABLING THIS TRULY SPECIALIZED
MEDICAL CARE AND STUDIES THAT
REALLY CANNOT BE DONE WHEN ONLY
ONE CASE EXISTS IN ANY GIVEN
REGION. SO COMPILING RESOURCES
FOR THESE RARE DISEASES IN ONE
SPACE AND BRINGING IN PATIENTS
FROM ALL FIFTY STATES IS MORE
FEASIBLE AND COST-EFFECTIVE FOR
EACH SINGLE PATIENT. THE
RESOURCES HERE AT THE CLINICAL
CENTER PROVIDE A UNIQUE
OPPORTUNITY FOR TRANSLATION
WHICH CAN REALLY ONLY BE DONE IN
OUR INTRAMURAL RESEARCH PROGRAM.
SO TODAY I'D LIKE TO TELL YOU
ABOUT TWO OF MANY OF THESE
TRANSLATIONAL PROGRAMS ANDLY
START WITH FIBROUS DISPLAY SHA
OR ACUTE ALBRIGHT SYNDROME. SO
YEARS AGO DR. PAM WAS WORKING ON
BONE MARROW SKELETAL STEM CELLS
OR SSCS THAT MAKE BONE,
CARTILAGE, MARROW FAT AND STROMA
CELLS WHICH SUPPORT HE MAT TOPO
WEE SIS, SHE CONFIRMED THIS IS
TRUE BY GROWING CELLS AND THEN
TRANSPLANTING THEM INTO A MOUSE
MODEL AND INDEED THESE
TRANSPLANTS WERE ABLE TO MAKE
EACH LINE OF CELLS AND THEY WERE
ABLE TO SUPPORT HE MAT TOPO WEE
SIS WHICH IS A DEFINING
CHARACTERISTIC OF STROMA CELLS
SHE THEN HYPOTHESIZED THAT THESE
CELLS ARE CENTRAL TO SKELETAL
HOMEOSTASIS IT WAS FOUND THAT
THEY SECRETE FACTORS SUCH AS SGF
23 THE BASIS OF MY RESEARCH
PROGRAM AND COPEP TIN THE
PRECURSOR OF VASOPRESSIN THAT
CONTROLS BLEEDING PROCESS
STUDIED BY DR. AVA. AND
FURTHERMORE SHE HYPOTHESIZED
THAT A MUTATION IN THESE
SKELETAL STEM CELLS COULD CAUSE
SKELETAL DISEASE AND THIS
BROUGHT HER TO THE STUDY OF THE
ALBRIGHT SYNDROME A DISORDER
CAUSED BY THE FUNCTION VARIANTS
SO PATIENTS WITH THIS DISEASE
HAVE EXPANSE BONE LESIONS KNOWN
AS DISPLAY THAT THAT CAN RESULT
IN DEFORMATIVES, FRACTURES AND
PAIN AND THERE ARE NO
ESTABLISHED TREATMENTS FOR THIS
THIS DISORDER SO SHE AND HER
TEAM OBSERVED THIS AND
POSTULATED THAT STEM CELLS WOULD
BE THE DRIVING FACTOR IN FD. SO
THIS MODEL OF TRANSLATIONAL
RESEARCH THAT I SHOW HERE IS ONE
THAT WE'VE EMPLOYED IN SEVERAL
DISEASE MODELS HERE. SO WE MAKE
OBSERVATIONS, COLLECT BIO
SPECIMENS AND DRAW HYPOTHESES
FROM OUR PATIENT TO DRIVE BASIC
SCIENCE WORK AT THE BENCH
GAINING MECHANIC IN THIS CASIC
KNOWLEDGE THAT DRIVES PREVENTION
AND CLINICAL TREATMENT TRIALS.
SO, SHE STUDIED THE SKELETAL
STEM CELL WITH AN ACTIVATED GENE
ALPHA S AND FOUND THIS PREVENTED
THE CELL FROM MAKING CARTILAGE
OR BAN MARROW STROMA CELLS IN
FACT THIS MADE ONLY ABNORMAL
OSTEOBLASTS. WHICH ARE THE
CAUSE OF THIS DISORDER. SO HERE
YOU CAN SEE NORMAL BONE BUT HERE
IN THE SAMPLE FROM A PATIENT BE
FD YOU CAN SEE WOVEN BONE AND
MARROW FIBROSIS AND NOTABLY BLI
SHE TRANSPLANTED CELLS INTO THE
MOUSE AND FOUND A PAT PERSON
THAT REALLY IMICED THIS PATIENT
BIOPSY THAT YOU CAN SEE HERE.
SO THIS BASIC WORK HAS BEEN
TRANSLATED TO CLINICAL CARE WHEN
DR. MICHAEL COLLINS BEGAN OUR
CLINICAL PROTOCOL IN 1998 WITH
THE GOAL OF DEFINING THE
SPECTRUM OF DISEASE ESTABLISHING
STANDARDS OF CARE AND DEVELOPING
NOVEL TREATMENTS. DR. ALISON, A
SCHOLAR AND TENURED TRACK
INVESTIGATOR NOW LEADS THIS
STUDY THAT HAS OVER 300 PATIENTS
SO PATIENTS TYPICALLY VISIT THE
CLINICAL CENTER FOR A WEEK
DURING WHICH THEY HAVE
LABORATORY STUDIES AND
RADIOLOGIC STUDIES AND THEY SEE
SEVERAL DIFFERENT CONSULTANTS
AND THIS STUDY HAS TRULY CHANGED
THE LANDSCAPE FOR PATIENTS WITH
FDMAS. SO YOU MIGHT RECALL IN
THIS IMAGE A FIBROUS BONE THAT
WAS SEEN ON HISTOLOGY AND SHE
WONDERED WHAT ROLE THEY MIGHT
PLAY IN THE PATHOGENESIS OF FD.
SO OSTEOBLAST ARE KNOWN TO
INTERACT WITH OSTEOCLASTS. AND
THIS CROSSTALK BETWEEN CELLS
INDUCES OSTEOPLAST PRECURSORS TO
FUSE AND DIFFERENTIATE INTO
THESE ACTIVE OSTEOCLASTS. AND
INTERESTINGLY, RANKL IS HIGHLY
EXPRESSED AS YOU CAN SEE WITH
THE ARROWS HERE ILLUSTRATING THE
CELLS AND YOU CAN SEE THE RANKL
LEVELS CORRELATED WITH THE
BURDEN IN FD PATIENTS AND THE
OBSERVATIONS GAINED FROM THESE
PATIENT SAMPLE LED HER TO A NEW
INTERESTING HYPOTHESIS. SO SHE
HYPOTHESIZE THAT HAD SHE COULD
REPURPOSE THE DRUG DENOS SAY MAB
TO SERVE AS A NOVEL TREATMENT
STRATEGY TO DECREASE FD LESION
ACTIVITY AND INCREASE LESION
MINERAL SAYINGS SO BY
INTERFERING HERE WITH RANKL
SIGNALLING AT THE PRECURSORS
INTO THE ACTIVE OSTEOCLASTS AT
THE BENCH, THEY USED A MOUSE
MODEL TO SHOW THE POTENTIAL FOR
RANKL INHIBITION TO INCREASE
BONE INFLAMMATION AND YOU CAN
SEE HERE THE BIOPSY OF THE WILD
TYPE MOUSE SHOWING THE BONE
MARROW CONSISTENT WITH THE
PATIENT PHENOTYPE HERE HERE THE
FD MOUSE HAS THIS WOVEN BONE AND
MARROW FIBROSIS AND
ADMINISTRATION OF ANTI-RANKL WAS
ABLE TO SUPPRESS THE ACTIVITY
AND RESTORE THIS NORMAL LA
MEDICAL LAR BONE FORMATION AND
IN INDEED THIS PRECLINICAL WORK
WAS TRANSLATED INTO THE PATIENT
POPULATION IN A CLINICAL TRIAL
LED BY DR. BOISE WHERE PATIENTS
WERE GIVENS IS DENOS SUE MAB AND
SAW IMPROVEMENT. ADDITIONALLY
SEEN HERE ARE THE PET SCANS THAT
SHOWED MARKED DECREASE IN
ACTIVITY SO AT BASELINE THESE
LESIONS ARE REFLECTED BY THIS
DARK ACTIVE REMODELLING BONE BUT
AFTER SIX MONTHS ON DENOS SUE
MAB THE ACTIVITY IS DECREASED
SIGNIFICANTLY AND REALLY
IMPORTANTLY, THE PATIENTS
REPORTED IMPROVEMENT IN THEIR
PAIN, AND IN THE PHYSICAL
FUNCTION. SO BACK TO THE BENCH
NOW. AS WORK ON THE SKELETAL
STEM CELLS HAS CONTINUED, THE
LAB NOTED BASED ON THEIR
MULTIPOTENT NATURE SKELETAL STEM
CELLS ARE PRIME CANDIDATES FOR
THE DEVELOPMENT OF TREATMENT IN
BOOSTING THESE VARIOUS CELL
TYPES AND THIS COULD REALLY HAVE
IMPLICATIONS IN THE TREATMENT OF
OSTEOPOROSIS, OSTEOARTHRITIS AND
AGING SO THE GROUP IS WORK
EXTENSIVELY ON DEVELOPING
METHODS TO USE THESE CELLS FOR
REGEN RATION OF BONE AND
CARTILAGE, LOSS DUE TO TRAUMA
AND DISEASE. SO THEY ALSO NOW
ROUTINELY USE CD34 POSITIVE
PERIPHERAL BLOOD CELL TO DEVELOP
IPSCS GIVING US A HUMAN BASED
MODEL THUS CELLS FOR NORMAL
INDIVIDUALS AND CELLS FROM
PATIENTS WITH VARIOUS DISORDERS
CAN BE USED TO DEVELOP IPCS THAT
CAN STUDY NEW DISEASES, STUDY
REGEN RATION OF A VARIETY OF
TISSUES AND DEVELOP CURES SO NOW
I WOULD LIKE TO SHIFT GEARS A
LITTLE BIT AND TALK ABOUT A
DISEASE I'M STUDYING. HNTC.
THIS IS A DISORDER OF FTF
DEFICIENCY THAT LEADS TO HIGH
PHOSPHATE LEVELS AND CAN CAUSE
LARGE CALCIFICATIONS AS YOU CAN
SEE OVER HERE AND THE MOST
PENETRATING FEATURE OF THIS CELL
IS THE DENTAL PHENOTYPE
CONSISTING OF THE SHORT BULBOUS
ROOTS AND PULP STONES AND HFTC
HAS THE POTENTIAL TO INFORM
CHRONIC COMMON DISORDERS SUCH AS
HYPER PHOSPHOTEAM YA OF CHRONIC
RENAL FAILURE AND VASCULAR
CALCIFICATION. SO MY GROUP
FOLLOWS RESEARCH AT THE BENCH
WHERE ACTIVELY TESTING THE ROLE
OF PRESSURE AND CALCIFICATION
DEVELOPMENT AS WELL AS THE
EFFECTS OF TREATMENT WITH THE
NOVEL COMPOUNDS ON
CALCIFICATION. AND WE'RE ALSO
IN THE PROCESS OF INITIATING AN
IND CLINICAL TRIAL TO REPURPOSE
A DRUG FOR USE IN PATIENTS WITH
HFTC. MUCH LIKE THE WORK I
DESCRIBED IN FDMAS WE'VE BEEN
DEFINING THE NATURAL HISTORY OF
THESE PATIENTS AND WE NOW CARE
FOR THE WORLD'S LARGEST WE'LL
STUDIED COHORT OF PATIENTS WITH
HFTC. SO WE'RE ESTABLISHING NEW
STANDARDS OF CARE AND DEVELOPING
A NEW TREATMENT TRIALS AND TODAY
I'M GOING TO TELL YOU ABOUT MY
WORK TO CHARACTERIZE VASCULAR
CALCIFICATION AND TO IDENTIFY
BUY QUO MARKERS. REMEMBER
BIOMARKERS ARE CRITICAL TO THE
ABILITY TO ASSESS THE
PROGRESSION OF A DISEASE AND THE
EFFICACY OF TREATMENT AND TO
DEFINE MININGFUL AND POINTS SO
THAT WE CAN CONDUCT A CLINICAL
TRIAL. SO THROUGH OUR CLINICAL
OBSERVATIONS, WE HAVE REALIZED
THE NEED TO UNDERSTAND THE
EVOLUTION OF PATIENT
CALCIFICATIONS SO WE INITIATED
THE USE OF SODIUM FLUORIDE PET
SCANS IN THIS PATIENT POPULATION
AND DEVELOPED A TECHNIQUE TO
IDENTIFY AND QUANTIFY VASCULAR
CALCIFICATION IN HFTC BY
ISOLATING AND THEN DISSECTING
OUT THE AORTA. AND THIS LED TO
OUR FINDING THAT VASCULAR
CALCIFICATION WAS PREVALENT AS
PEFDED BY THE SCORE IN THIS
GRAPH WHERE THE YAY GREY AREA IS
THE NORMAL RANGE AND EACH LINE
REPRESENTS A PATIENT. WE WERE
SURPRISED TO FIND THAT THE
CALCIFICATION WAS PRESENT IN OUR
PEDIATRIC PATIENTS AND THIS
FINDING HAS LED US TO INCREASE
MONITOR FOR PATIENTS AT HIGH
RISK SO EARLY INTERVENTION CAN
TAKE PLACE IMPORTANTLY WE WERE
ABLE TO MONITOR CHANGES OVER
TIME IN THE RESPONSE TO
TREATMENT AND THIS IS A PATIENT
WITH EXTENSIVE INFLAMMATION WHO
WAS TREATED WITH AN ANTAGONIST
FOR FIFTEEN MONTHS BRINGING HER
INFLAMMATORY MARKER FROM HIGH
DOWN INTO THE NORMAL RANGE AND
AS YOU CAN SEE SHE HAD IMPROVED
CALCIFICATION WHICH WE COULD
BOTH DEFECT AND QUANTITY TODAY.
SO THE POTENTIAL FOR THIS
TECHNIQUE TO ACT AS A NEW
BIOMARKER AND THUS AN END POINT
FOR OUR CLINICAL TRIAL IS
SIGNIFICANT AND NOTABLY THIS
TECHNIQUE IS DETECTING THE
ACTIVITY WITH CALCIFICATION AT
AN EARLY TIME POINT BEFORE IT
CAN BE SEEN ON TRADITIONAL CT
SCAN. AND WE'RE CURRENTLY USING
ARTIFICIAL INTELLIGENCE OR AI TO
CREATE A COMPUTATIONAL METHOD TO
DO THIS ANALYSIS. THUS
INCREASING RELIABILITY AND
REPRODUCIBILITY OF THE DATA
WHILE MINIMIZING THE TIME NEEDED
TO MANUALLY CALCULATE THAT
CALCIFICATION SCORE AND THIS
TECHNIQUE IS APPLICABLE TO
NUMEROUS OTHER DISEASES OF
VASCULAR CALCIFICATION AND WE
HAVE SEVERAL NEPHROLOGISTS FROM
CENTERS WHO ARE EAGER TO
COLLABORATE AND TRANSLATE THIS
TECHNIQUE TO PATIENTS WITH
CHRONIC RENAL FAILURE AND ALONG
THESE SAME LINES WITH
COMPUTATIONAL ANALYSES THE NEXT
TALK WILL BE ABOUT THE WORK FROM
DR. JAN'S LAB OF THE ANALYSIS OF
CRANIOFACIAL GROWTH AND
DEVELOPMENT. IN SUMMARY I'VE
SHONE YOU ONLY A FEW EXAMPLES OF
THE WORK FROM THE SKELETAL
MATRIX AND MECHANICAL BIOLOGY
GROUP AND YOU CAN SEE HOUR MODEL
OF MORTGAGING RESEARCH AND
CLINICAL CARE WHICH INFORMS
QUESTIONS AND HYPOTHESES ABOUT
OUR PATIENTS. WE THEN EMPLOY
SEVERAL MODEL SYSTEMS INCLUDING
IPSCS, MOUSE MODELS AND
COMPUTATIONAL ANALYSES TO ANSWER
THESE QUESTIONS. AND WE TAKE
THIS INFORMATION INTO
PRECLINICAL AND CLINICAL TRIALS.
TO REALLY DIRECTLY IMPROVE
DIAGNOSIS. PROGNOSIS AND
TREATMENT OF OUR PATIENTS. SO
THANK YOU SO MUCH FOR YOUR TIME
AND NOW I WOULD LIKE TO
INTRODUCE DR. AL PAN KNOW, A
STAFF CLINICIAN IN THE DOCTOR'S
LABORATORY WHO WILL PRESENT
ABOUT CRANIOFACIAL GROWTH.
>> THANK YOU FOR THE SP
INTRODUCTION CAN YOU SEE MY
TITLE SLIDE?
>> YES.
>> SO MY PRESENTATION IS GOING
TO BE ABOUT THE PREDICTION OF
CRANIOFACIAL GROWTH.
CRANIOFACIAL DIFFERENCES ARE
BIRTH DEFECTS THAT AFFECT THE
STRUCTURE AND SCAPE OF THE SKULL
AND FACE. THEY CAN APPEAR AS AN
ISOLATED DEFORMITY SUCH AS CLEFT
PALATE OR AS PART OF THE
CONDITION LIKE THE SYNDROME
MENTIONED EARLIER. OUR STUDY OF
RARE DISEASES INFORMS MORE
CRANIOFACIAL DIFFERENCES SUCH AS
SKELETAL MALOCCLUSION IS
CHARACTERIZED BY THESE AND
OCCURS IN 19% OF THE U.S.
POPULATION. YOU CAN SEE THE OR
NOTHING NATTIC TYPE. AND YOU
CAN SEE THE OVERBITE WITH THE
CONVEX PROFILE. AND CLASS THREE
WHICH IS AN UNDERBITE WHERE A
CONCAVE PROFILE. MODERATE TO
SEVERE TYPES OF MALOCCLUSION
HAVE BEEN ASSOCIATED WITH
PROBLEMS SUCH AS CHEWING OR
SPEECH OR SLEEP APNEA, JOINT
DISORDERS AND DIGESTIVE ISSUE AS
WELL AS BURDEN WITH REDUCED ORAL
RELATED QUALITY OF LIFE.
DEVELOPMENT OF THE HUMAN SKULL
AND FACE IS A HIGHLY
ORCHESTRATED THREE-DIMENSIONAL
MORE FOE GENETIC PROCESS.
THERE'S THEREFORE NOT SURPRISING
THAT GENETIC INSULTS APPEAR IN
CRANIOFACIAL DIFFERENCES.
INCLUDING THE OCCLUSION. WE
ALSO KNOW THAT THE ROLE OF THE
CRANIAL BASE IN THE DEVELOPMENT
OF THE COMPLEX IS VERY IMPORTANT
HOWEVER IT'S ROLE IN THE
DEVELOPMENT OF THE MALOCCLUSION
REMAINS CONTROVERSIAL. IT IS
IMPORTANT TO NOTE THAT THE
GROWTH OF THE ENTIRE ANTERIOR
CRANIAL BASE IS COMPLETE BEFORE
THE AGE OF SIX YEARS. AS WELL
AS THE MANDIBLE. AS SHOWN ON
THE RIGHT-HAND SIDE OUR
HYPOTHESIS IS THAT THE CRANIAL
BASE DICTATES THE GROWTH AND THE
DEVELOPMENT OF THE MAXILLA AND
MANDIBLE. UNLIKE CRANIAL BASE
DEVELOPMENT, THE PHENOTYPE IS
NOT EXPRESSED UNTIL EARLY
ADOLESCENCE, HOWEVER, THE
PREVENTION OR TREATMENT OF
SKELETAL MALOCCLUSION IS
IMPORTANT FOR THE WELL-BEING OF
THOSE INDIVIDUALS MOREOVER,
EARLY DIAGNOSIS IN THIS CASE
WILL ENABLE MORE EFFECTIVE
TREATMENT AMROECHS IN DEFINING
THE BEST TIMING AND TYPE OF
INTERVENTION. ESPECIALLY THE
CASE OF OCCLUSION OR UNDERBITE
THIS IS EVEN MORE CRUCIAL. THE
REASON IS THAT SOME OF THESE
CASES WHEN THE MAIN ETIOLOGY OF
THE UNDERBITE IS THE
UNDERDEVELOPMENT OF THE MAXILLA
RESPOND WELL TO THE TREATMENT
WITH PROTRACTION WHICH IN MOST
CASES CAN RESOLVE THE PROBLEM.
IN THE CASE OF SKELETAL
UNDERBITE THAT IS DUE TO
OVERDEVELOPMENT OF THE MANDIBLE
WHICH IS NAMED AS CLASS THREE B
THERE'S NOTHING WE CAN DO
CLINICALLY TO CONTROL THE GROWTH
OF THE MANDIBLE WHICH CAN ALSO
CONTINUE TO GROW UNTIL LATE
ADOLESCENCE, MANY OF THESE CASES
REQUIRE SURGE DUE TO THE
MAGNITUDE. SO AT THE AGE OF
POTENTIAL INTERVENTION WHICH IS
BEFORE PUBERTY THE SKELETAL
MALOCCLUSION FEN TYPE IS NOT
FULLY EXPRESSED AND THE
DIAGNOSIS CANNOT BE MADE AS YOU
CAN IMAGINE THIS IS VERY
FRUSTRATING FOR CLINICIANS AND
OF COURSE THE PATIENTS AND THEIR
FAMILIES. OUR AIM WAS TO
EXPLORE THE ROLE. AND THEN
DETERMINE WHETHER CANE E CRANIAL
BASE SHAPE COULD ASSIST US IN
THE EARLY DIAGNOSIS OF THE
PHENOTYPE. SO THIS AN OLD
PROBLEM BUT THERE'S NOW NEW
TECHNOLOGY AVAILABLE THAT WE CAN
USE TO SOLVE IT WHICH IN THIS
CASE IS 3D IMAGING WE USE 306
FULL HEAD COMPUTER TOMOGRAPHY
SCAN THERE'S HEALTHY INDIVIDUALS
AS PART OF A NORMATIVE COHORT.
43, 3D VALIDATED LANDMARKS AND
THAT PROVIDE THE SUFFICIENT
COVERAGE OF THE CRANIOFACIAL
COMPLEX AND WERE ANNOTATED ON
THE VOLUMES. THESE WERE
EXPORTED AND USED FOR THE
CONDUCTION OF ANALYSIS WHICH IS
A TYPE OF SHAPE ANALYSIS. AFTER
REGRESSING FOR SIDES, AGE AND
SEX WE CONDUCTED THE ANALYSIS
FOR THE EXPLORATION OF THE SHAPE
OF VARIATION BETWEEN THE
SKELETAL MALOCCLUSION GROUPS IN
THE PCA PLOT ON THE RIGHT WHICH
EXPLAINS 100% OF THE SHAPE
VARIATION IN OUR DATASET YOU CAN
APPRECIATE THE DISTINCT
CLUSTERING OF THE GROUPS IN DOT
IN THIS PLOT REPRESENTS ONE
INDIVIDUAL. AND WE ALSO
EXPLORED THE SHAPE OF THE
CRANIAL BASE BETWEEN THE MAIN
GROUPS. WITH A USE OF CANONICAL
VARIATE ANALYSIS WHICH SHOWED
THE DIFFERENCES BETWEEN THE ONE
AND TWO GROUPS. BE THE
ADDITIONAL SEPARATION BETWEEN
THE CLUSTER A AND 3B SUBGROUPS
BASED ON THE CROSS VALIDATION
ANALYSIS FOR THE QUALITATIVE
ASSESSMENT OF THE PROBABILITY OF
AN INDIVIDUAL CLASSIFYING AS
CLASS 3A OR CLASS 3B THE
ACCURACY OF THE MODEL WAS 90.3%.
FOR THE REPRODUCIBILITY WE USE
TEN TEST CASES TO TEST OUR MODEL
WHICH WERE INDIVIDUALS BEFORE OR
DURING PUBE IRTY AND SKELETAL
CELL MATURATION. I USE HERE THE
EXAMPLE THE CASE OF THE MALE
PATIENT THAT PRESENTS WITH THE
SKELETAL RELATIONSHIPS AND NO
DENTAL UNDERBITE. WE CAN SEE ON
TRIETH THAT THE SAME INDIVIDUAL
AT AGE 19 HAS A FULL UNDERBITE
IN THE MANDIBLE. WHEN
PROJECTING THIS INDIVIDUAL IN
THE NORMATIVE COHORT PCA PLOT WE
CAN SEE THAT AT T 1 WITH THE
YELLOW CIRCUMSTANTIAL DOT IS
CLOSER TO THE CLASS 3B GROUP
WHICH WAS CONFIRMED WITH THE
CROSS VALIDATION ANALYSIS SO OUR
CONNOTATIVE APPROACH COULD HAVE
SUCCESSFULLY PREDICTED THE
OVERDEVELOPMENT OF THE MANDIBLE
AND WE HAD THE SAME SUCCESS WITH
THE REST OF OUR TEST CASES WE
CONFIRMED THE HYPOTHESIS THAT
THE CRANIAL BASE DICTATES THE
PHENOTYPE. GEOMETRIC ANALYSIS
IS A COMPETITIONAL TOOL THAT CAN
BE USED FOR THE EARLY ACCURATE
DIAGNOSIS OF THE TYPE OF
SKELETAL MALOCCLUSION A LOT
SOONER THAN WHEN THE PHENOTYPE
IS EXPRESSED CLINICALLY THIS
CRANIOFACIAL TOOL CAN BE USED
FOR CUSTOMIZED PLANNING AND IS
TO INCREASE THE BLANK OF
PATIENTS. THANK YOU FOR YOUR
ATTENTION.
>> THANK YOU. WE'LL NOW MOVE TO
PLENARY SESSION THREE. ON
GENOTYPE APPROACHES. DR. KEEN
AND DR. JACKIE MAYS. AKEEN
AND DR. JACKIE MAYS.
DR. ACHKEEN AND DR. JACKIKEEN A
MAYMKEEN AND DR. JACKIE
MAYS. DR. ACHIMN
AND DR. JACKIE
AND DR. JACKIE MAYS.
>> THANK YOU VERY MUCH
DR. WEBSTER. I HOPE THAT YOU
CAN SEE MY SLIDES AND EVERYTHING
CORRECTLY AND I DON'T HEAR
ANYTHING RIGHT NOW I WILL JUST
CONTINUE. SO I AM REALLY
EXCITED TO BE HERE TODAY. I'M A
RECENKRENTCENT LY TENURED INVES
AND I WANT TO CONTINUE WITH THIS
BASIC RESEARCH THAT IS REALLY
POSSIBLE HERE IN THE INTRAMURAL
PROGRAM THAT YOU'VE HEARD FROM
DR. WEBSTER, FROM DR. WARNER AND
DR. ROSCOE AND I WANT TO DO IT
DIFFERENTLY. I WANT TO SHARE MY
JOURNEY WHICH HAS BEEN CRUCIALLY
SHAPED BY MANY COLLABORATIONS
WITHIN NIH. AND ALSO BY THE
UNIQUE CLINICAL ENVIRONMENT. I
AM A CHEMIST BY TRAINING AND
ALSO A STEM CELL BIOLOGIST AND
MY LAB CENTERS AROUND THE
CENTRAL REGRESSION OF MY LAB IS
HOW CELLS ARE DETERMINED DURING
DEVELOPMENT AND WE FOCUS ON A
SMALL PROTEIN CALLED YUBIQUITIN
THAT LOOKS AT DIFFERENTIATION.
TO GIVE YOU AN INTRODUCTION, YOU
CAN SEE HERE A STEM CELL THAT IS
ABLE TO REVERSIBLY EXIT A STATE
AND GIVE RISE TO MORE STEM CELLS
OR THE CELL CAN ALSO DECIDE TO
UNDERGO DIFFERENTIATION TO GIVE
RISE TO THE MORE THAN 200
DIFFERENT CELL TYPES THAT MAKE
UP OUR HUMAN BODY. MANY IF NOT
ALL OF THESE CELL DECISIONS ARE
CRUCIALLY CONTROLLED BY YOU PICK
RITY REGULATION AND I CAN SHOW
YOU HOW THESE ACHIEVE THIS.
BUT HAVE WORKED ON DURING MY
GRADUATE AND POSTGRADUATE CAREER
BEFORE COMING TO THE NIH. NOT
SURPRISINGLY FROM THESE
ESSENTIAL FUNCTIONS THE
MUTATIONS IN THE ENZYMES HAVE
BEEN FREQUENTLY LINKED TO HUMAN
DISEASES THAT ARE STUDIED ACROSS
THE NIH AND INCLUDE CANCER,
NEURODEGENERATION AND I WILL
GIVE YOU EXAMPLES TODAY,
CONGENITAL DISEASES THAT EFFECT
BRAIN AND CRANIOFACIAL
DEVELOPMENT AS WELL AS
AUTOINFLAMMATION. SO WHAT ARE
THESE UBIQUITYLATION ENZYMES.
THEY ARE IDENTIFIED BY A
CASCADE, CONSISTING OF E 1, E 2
AND E 3 LIE GIETING ENZYMES THAT
ALL COLLABORATE TO ATTACH THE
SMALL PROTEIN TO A SUBSTRATE.
THIS IS VE VERSABLE AND CAN BE
REVERSED BY THE YOU DEUBIQUITY
LACES AND THIS PROCESS CAN HAVE
MANY DIFFERENT FUNCTIONS IN
CELLS INCLUDING MEDIATING
PROTEASE SOME MALL DEGRADATION
OR CELLULAR SIGNALLING.
AND THIS CODES TO THE ENZYMES
ROUGHLY 2 E 1S, 40 E 2S, AND 600
E 3S. AND DESPITE FOR US DOING
RESEARCH ON THE SYSTEM FOR MORE
THAN 40 YEARS NOW, WE KNOW
SURPRISINGLY LITTLE OF MOST OF
THE ENZYMES SO DEFINING THOSE IS
STILL A MAJOR QUESTION TO BE
SOLVED IN OUR RESEARCH FIELD.
SO MY LAB HAS COMBINED
BIOCHEMICAL APPROACHES WITH
INDUCED STEM CELL MODEL TO
ASSIGN PHYSIOLOGICAL FUNCTIONS
OF THE ENZYMES DURING
DEVELOPMENT AND CELL-FATE
DECISIONS AND WE HAVE THE
PROGRAM THAT LEVERAGES THE
UNIQUENESS OF THE NIH AND
TOGETHER WE IDENTIFY UNDIAGNOSED
DISEASE PATIENTS WHO CARRY
VARIANTS AND STUDY THESE
VARIANTS IN OUR INVITRO AND
CELLULAR MODELS TO LEARN ABOUT
THE PHYSIOLOGICAL FUNCTIONS. WE
THEN CONFIRM OUR INVIVO FINDINGS
IN ANIMAL MODELS BY
COLLABORATING WITH BIOLOGISTS
AND ALSO STARTED TO USE
STRUCTURAL BIOLOGY APPROACHES
INTO OUR INVESTIGATIONS BY
COLLABORATING WITH LOCAL EXPERTS
IN STRUCTURAL BIOLOGY. AND THIS
REALLY INTEGRATED AND HIGHLY
COLLABORATIVE APPROACH USING
GENOTYPE FIRST STRATEGIES AND
STARTING FROM UNDIAGNOSED
DISEASE PATIENTS AND GOING INTO
DEEP MOLECULAR MECHANISM THAT
ALLOWED US NOT ONLY TO DISCOVER
UNRECOGNIZED DISEASES BUT ALSO
HAS PROVIDED FUNDAMENTAL
PRINCIPLES OF YOU WICK PI TEN.
OVER THE LAST SEVEN YEARS WE
ESTABLISHED THREE INDEPENDENT
AREAS THAT CENTER AROUND THE
QUESTION HOW PARTICULAR CLASSES
OF THESE UBIQUITYLATION ENZYMES
CONTROL SUBSTRATE FATE TO
DETERMINE THE HEALTH AND
DISEASE.
IN TWO OF THESE AREAS, HAVE BEEN
DONE IN VERY CLOSE COLLABORATION
WITH LAURA WITH A STAFF INVE
INVESTOR -- INVESTIGATOR. AND
WE LOOK AT HOW THESE CAUSE
DEFECTS IN NEURAL CRESTS AND
NEURAL DEGRADATION THAT AFFECT
THE BRAIN AND CRANIOFACIAL
DEVELOPMENT AND THE CELL TYPE,
EARLY DEVELOPMENT OF THE BRAIN
AND THE FACE. TODAY HOWEVER I
WANT TO FOCUS ON THIS FIRST
RESEARCH AREA HERE IN WHICH WE
INVESTIGATE THE INITIAL STEPS OF
THE YOU WICK WETILATION CASCADE
WHICH IS EYE PICK WE TIN
ISOLATION. IN HERE WE HAVE THE
MUTATIONS IN THE ENZYME WHICH
CAUSE A LATE ONSET
AUTOINFLAMMATORY DISEASE AND BY
STUDYING THESE MUTATIONS WE
REALLY UNCOVERED NEW PRINCIPLES
OF HOW REGULATION CONTROLS THE
CELL DECISIONS. AND I'M REALLY
EXCITED TO TALK ABOUT THIS
RESEARCH AREA HERE TODAY.
BECAUSE IN MY OPINION IT REALLY
ILLUSTRATES THE STRENGTHS OF THE
NIH AND THE INTRAMURAL PROGRAMS
THAT REALLY BRING TOGETHER ALL
THE NECESSARY EXPERTISE AND
INFRASTRUCTURE TO ALLOW TO START
WITH DISEASE DISCOVERY THEN
STUDY THE UNDERLYING MECHANISM
AND LEARN ABOUT BASIC BIOLOGICAL
PROCESSES BUT THEN ALSO GO BACK
FULL CIRCLE AND USE THE GAINED
KNOWLEDGE TO INFORM AND DEVELOP
THERAPIES. SO THIS RESEARCH
AREA STARTED WHEN I FIRST CAME
TO THE NIDCR. AND I MET DOCTORS
DAVID BECK AND DANIEL CAST
NEVER, WHO RESEARCHERS AND GIVEN
THAT MUTATIONS IN THE ENZYMES
ARE FREQUENTLY LINKED TO HUMAN
DISEASES, WE DECIDED TO TAKE
GENOTYPE FIRST DISEASE DISCOVERY
STRATEGY AND SYSTEMATICALLY
SEARCHED EXOME AND GENOMES OF
PATIENTS IN THE AUTOINFLAMMATORY
AND UNDIAGNOSED DISEASE COHORTS
FOR VARIANTS IN UBIQUITYLATION
ENZYMES FOCUSING ON ESSENTIAL
GENES, VARIANTS THAT ARE NOT
FOUND IN THE GENERAL FOUND IN
THE HUMAN POPULATION. AND THIS
INCLUDED THREE MIDDLE-AGED MEN
AT THE SAME RESIDUE AND WHAT WAS
UNUSUAL FOR THESE INFLAMMATORY
DISEASES IS THAT THESE MUTATIONS
ARE NOT GERMLINE BUT RATHER
ACQUIRED SOMATIC. THEORY
STRICTED TO THE LINEAGE WHERE
THEY ARE PRESENT IN THE STEM
CELLS AND THEN THEY GET ENRICHED
IN THE LINEAGE ALL THE WHILE
TYPE CELL BUT NOT AT THE LYMPH
NODE WHERE THEY'RE CALLED LARGE
VACUOLES IN THE INFLAMMATORY
SIGNALLING AND WE FIND THEM TO
BE THE SOURCE OF INFLAMMATION
THAT IS CALLED VEXAS. THIS IS
CHARACTERIZED BY SEVERE
AUTOINFLAMMATION THAT EFFECTS
MANY SYSTEMS. THERE'S THIS
REALLY LARGE CHARACTERISTIC
VACUOLES THAT WE SEE IN THE BONE
MARROW CELLS. UNFORTUNATELY,
THIS IS OFTEN FATAL AND IT TURNS
OUT TO BE SURPRISINGLY PREVALENT
AS EVIDENCED BY THE RECENT
REPORT THAT IT AFFECTS ONE IN
FOUR THOUSAND MALES OVER 50
MAKING IT THE MOST COMMON
GENETIC AUTOIMMUNE DISEASE TO
DATE AND PUTTING IT IN THE RANGE
OF SICKLE CELL ANEMIA. THUS
WITH THOUSANDS OF PATIENTS WORLD
WIDE, THIS IS A SIGNIFICANT
HEALTH BURDEN AND WE NEED AN
UNDERSTANDING OF THE DISEASE TO
COME UP WITH EFFECTIVE
THERAPIES. SO THIS END WE
ALREADY SHOWN THAT THIS IS
TRANSLATED INTO AN ISOFORM.
WHICH GIVES US THEN RISE TO
DIFFERENTLY SUBCELLULAR
ISOFORMS. THE MAJORITY OF VEXAS
MUTATIONS ARE AT NET 41 AND
CAUSE LOSS OF FUNCTION BUT FIRST
TRANSLATING AND THEN BY USING
TRUNCATED IMPAIRED ISOFORM THAT
WE TERMED UBA 1C IN A
COLLABORATIVE FOLLOW UP STUDY WE
CAN THEN SHOW THAT THE B AMOUNTS
ARE AN IMPORTANT PREDICTOR OF
THE PATHOGENESIS. STUDYING A
LARGE COHORT OF PATIENTS OF
ROUGHLY ONE HUNDRED WE COULD
SHOW THAT PATIENTS WITH THE B
PHENOTYPES SHOW HIGHER MORTALITY
BUT THIS PHENOTYPE PRODUCED
SIGNIFICANTLY LESS RESIDUE OF B
LEVELS THAN THE OTHER PHENOTYPES
REVEALING AN ASSOCIATION BETWEEN
THE RESIDUE AND MORTALITY IN
VEXAS AND THIS STUDY INFORMED
PATIENT TREATMENT AND PATIENT
WITH A SEVERE ALLELE ARE
RECOMMENDED FOR TRANSPORT THAT
WE DO HERE AT NIH AND IN THE
FOLLOWING TALK DR. JACKIE MAYS
WILL TELL YOU HOW SHE CARES FOR
THESE PATIENTS AFTER TRANSPLANT
AND THE CONTEXT OF A LARGER
CLINICAL RESEARCH PROGRAM
STUDYING THE ORAL MANIFESTATIONS
OF THIS DISEASE. IN ADDITION TO
THESE THAT LEAD TO THE ISOFORM
SWAP WE ALSO IDENTIFIED THERE'S
OTHER NON-CANONICAL MUTATIONS.
IN A CLOSE COLLABORATION WITH
DR. NADINE SAMARA WHO IS AN
INVESTIGATOR WE DETERMINED
VARIOUS MECHANISMS BY WHICH
THESE AFFECT THIS. AND I DON'T
WANT TO GO INTO ALL THE DETAILS
BUT WHAT WE CAN SHOW IS TOGETHER
WITH NADINE IS THAT ALL OF THESE
MUTATIONS, MOST PROMINENTLY
AFFECTED THE LAST STEP OF THIS
INTO THE TWO ENZYMES WHICH WE
CALL A TWO TRANSFER BOTTLENECK
WHICH AFFECTED THEM BOTH NUCLEAR
AND THE CYTOPLASMIC ISOFORM. SO
TOGETHER FROM THESE STUDIES OF
CANONICAL AND NON-CANONICAL
MUTATIONS WE THEN PROPOSED THAT
A MAJOR MECHANISM UNDERLYING THE
VEXAS IS THE LOSS OF CONJUGATION
TO CYTOPLASMIC E 2S, HOWEVER,
HOW THIS UNIQUE STATE CAUSES THE
ACTUAL INFLAMMATORY CYCLING IN
THE MATURE CELLS IS STILL AN
IMPORTANT OUTSTANDING QUESTION.
SO IN THE LAST COUPLE OF SLIDES
I'M EXCITED TO SHARE YOU, WITH
YOU OUR UNPUBLISHED WORK WHICH
WE ADDRESSED THIS QUESTION, WE
ENGINEERED AN INDUCIBLE MONOCYTE
MODEL THAT ALLOWS FOR A
REPLACEMENT OF THE ENDOGENOUS
WITH AN EITHER AN ECTOPIC WILD
TYPE OR A VEXAS ALLELE. WE'RE
EXCITED TO SEE THIS MODEL
RECAPITULATES THE VEXAS
HALLMARKS AS YOU CAN SEE HERE BY
THESE CLEARLY VISIBLE VACUOLES
AND WE CAN SHOW THAT THEY'RE
EXPRESSING THE VEXAS
CHARACTERISTIC CYTOKINES THAT
INCLUDE THE INTERFERONS. WE
THEN HYPOTHESIZE THAT HAD
PROTEOMIC ANALYSIS OF THESE
VEXAS MODEL CELLS IN AN EARLY
TYPE POINT AND THEN COMPARING IT
WITH THE DYSREGULATED PATHWAY
THAT WE FIND IN PATIENT CELLS
WOULD ALLOW US TO IDENTIFY THE
EARLY EVENTS THAT FOLLOW THIS
CYTOPLASMIC FUNCTION AND CAN
INITIATE THE CYCLING. IN THE
EXPERIMENTS THAT I DON'T HAVE
TIME TO SHOW YOU WE THEN
IDENTIFY THE PATHWAY AS AN EARLY
PATHWAY FOLLOWING DISRUPTION OF
SAY TO PLASMA UBIQUITYLATION
THAT DRIVES THE CELL
INFLAMMATION AND VERY EXCITINGLY
WE CAN DEMONSTRATE THIS IS
INDEED THE CASE WHICH I'M
SHOWING YOU THAT ONE OF MANY
EXPERIMENTS THAT WE PERFORMED,
WE ISOLATED EITHER MYELOID CELLS
OR HEALTHY DONORS, TREATED THEM
WITH INHIBITORS AND MONITORED
THE INFLAMMATION AND WE MIND
THAT THIS TREATED CELLS COMPARED
TO THE HEALTHY DONORS HAVE
UPREGULATION OF ALL THESE
DIVERSE PATHWAYS HOWEVER AS SOON
AS WE TREAT WITH AN INHIBITOR
YOU CAN SEE THESE PATHWAYS ARE
DOWN-REGULATED REALLY
DEMONSTRATING AN IMPORTANT ROLE
OF ASSOCIATED INFLAMMATION. SO
IN SUMMARY WHAT, I HAVE SHOWN
YOU TODAY IS THAT BY
COLLABORATING WITH DIFFERENT NIH
AGENTS IN THE LABS WE WERE ABLE
TO USE GENOTYPE FIRST DISEASE
DISCOVERY APPROACHES TO UNCOVER
A NEW PREVALENT AUTOINFLAMMATORY
DISEASE, STUDY ITS UNDERLYING
DISEASE MECHANISMS LEARNING
ABOUT FUNDAMENTAL PRINCIPLES OF
HOW UBIQUITY AND KNOW WE ARE IN
THE PROCESS TO GO FULL CIRCLE
AND REALLY TRY TO APPLY THIS
KNOWLEDGE TO DEVELOP NEW
THERAPIES, EXPLORING THE
POSSIBILITIES OF REDIRECTING THE
PATHWAY INHIBITORS THAT PASSED
PHASE ONE CLINICAL TRIALS. IN
ADDITION, WE'RE ALSO THRIVING TO
HERE -- IN THE INTRAMURAL
PROGRAM TO MAKE THE
TRANSMUTATION A VIABLE THERAPY
FOR THESE PATIENTS AND WITH
THIS, I'M HANDING IT OTHER TO
DR. JACKIE MAYS.
>> THANK YOU SO MUCH DR. WARNER,
IT IS A PRIVILEGE TO BE HERE
TODAY I AM A DENTIST AND AN
IMMUNOLOGIST AND MY GROUP HAS
BEEN ABLE TO MAKE ADVANCE TO
IMPROVE HUMAN HEALTH AND CANCER
SURVIVORS AT THE NIDCR MY GROUP
WORKS CLOSELY WITH THE CELL
TRANSPLANT PROGRAM WITHIN THE
NIH CLINICAL CENTER TO MONITOR
AND TREAT CHANGES IN THE ORAL
CAVITY. TRABS PLANT OF A NEW
IMMUNE SYSTEM IS FOR LIMB FOE IF
AS AND VEXAS SYNDROME.
THE USE OF HEMATIC CELL
TRANSPLANT IS LIMITED BY THE
CHRONIC GRAFT VERSUS HOST
DISEASE A CHRONIC
AUTOIMMUNE-LIKE DISEASE IN
TRANSPLANT SURVIVORS MY
LABORATORY TAKES A BEDSIDE TO
BENCH APPROACH TO INVESTIGATION
OF BOTH THE PATHOGENESIS AND
TREATMENT OF GRAFT VERSUS HOST
DISEASE IN THE ORAL CAVITY AND
TODAY I AM SHARING WITH YOU A
VIGNETTE ABOUT NOVEL TREATMENT
FOR ORAL GRAFT VERSUS HOST
DISE
DISEASE IN THE ORAL CAVITY THIS
MANIFESTS IN THE ORAL MUCOSA AS
YOU CAN SEE FROM THE CLINICAL
IMAGES TAKEN WITHIN THE NIDCR
CLINIC AND ALSO WITHIN THE
SALIVARY GLANDS THIS IMPACTS
PATIENT PAIN LEVELS AND
NUTRITIONAL IMPACT INTAKE IN
ADDITION TO QUALITY OF LIFE AT
THE NIH WE ARE TRACKING PATIENT
WHO IS UNDERGO TRANSPLANT FOR
VEXAS SYNDROME. SO FAR WE'VE
TRACKED FIVE OF THESE PATIENTS.
THREE OUT OF THE FIVE
TRANSPLANTED HAVE DEVELOPED ORAL
SEQU
SEQUELA 0 50% DEVELOPED ORAL
HOST DISEASE. AS THE DOCTOR
MENTIONED FOR PATIENTS WITH THE
MOST SEVERE, IT CAN BE KAURTIVE
AND ONE TOO FAR FEW TREATMENT
OPTIONS.
THIS BLOOD SMEAR ACCOMPANYING
QUANTITATION SHOWED THAT THE
SYNDROME ARE FOUND WITHIN HE MAT
TOPO WETTIC CELLS AND THESE ARE
REPLACED WITH THE TRABS PLANT.
NEW THERAPEUTICS ARE NEEDED THAT
IS . WE ARE PARTNERED AT THE
UNIVERSITY OF PITTSBURGH MEDICAL
CENTER TO STUDY BOTH THE SAFETY
AND EFFICACY OF PHOTO BIO
MODULATION THERAPY USING A
DEVICE TO TREAT THE INTRAORAL
TISSUES AND THE EXTRA ORAL
TISSUES IMPACTED BY ORAL GRAFT
VERSUS HOST DISEASE USING RED
LIGHT THERAPY AT 660 AND 850
NANOMETERS.
IN THIS DOUBLE BLIND PLACMRAPLA
CONTROLLED TRIAL. AND THEN THEY
ARE ABLE TO CONTINUE OPEN LABEL
TREATMENT FOR AN ADDITIONAL
MONTH. THE EFFICACY OF PHOTO
BIO MODULATION HINGES ON THE
MITOCHONDRIA THAT LEADS TO
INCREASED ATP AND OXYGEN
REDUCTION IN THE ACTIVITY AND
THE CORRESPONDING REDUCTION IN
THE PRODUCTION OF THE CYTOKINES
AND ALSO VEII SEW LIE DAGS THAT
IMPROVES TISSUE PROSOLUTION.
THIS BREAKS THE CIRCUIT. AND
PROMOTES TISSUE HEALING. COMING
BACK TO VEXAS, IN A PATIENT, AT
FOUR MONTHS POST TRANSPLANT THIS
PATIENT DEVELOPED CHRONIC GRAFT
VERSUS HOST DISEASE OF THE
MOUTH, THE SKIN AND THE EYES
THAT WAS INITIALLY TREATED WITH
A JAK 1/2 INHIBITOR THAT IS
EXPECTED TO BLOCK THE CYTOKINES
WHEN IT WAS TAPERED ISOLATED
GRAFT VERSUS HOST DISEASE FLARED
YOU CAN APPRECIATE HERE ON THE
HARD PALLET YOU CAN SEE THE
LESIONS HERE THROUGH THE LINE
AND EXTENDING OUT TO THE
DENTITION. THE PATIENT WAS
ENROLLED ON THE LIGHT TRIAL
WHICH IS THE PHOTO STUDY THAT I
JUST MENTIONED AND WAS GIVEN 18
TREATMENTS OF THE THERAPY. I
SHOULD MENTION THIS STUDY IS NOT
YET UNBLINDED SO IT'S NOT CLEAR
IF THE PATIENT RECEIVED ACTIVE
THERAPY DURING BOTH PHASES.
HOWEVER, AT DAY 56 AT THE
CONCLUSION OF THE OPEN LABEL
PERIOD WE WERE ABLE TO OBSERVE
COMPLETE MEDICAL RESOLUTION
SHOWN HERE ON THE PALLET OF THE
PATIENT. THE NIDCR IS
WELL-INTEGRATED INTO THE NIH
DISCOVERY ENGINE THAT IS
DIRECTED TOWARDS IMPROVING HUMAN
HEALTH OUR INTRAMURAL NETWORK
BRINGS STUDIES TO IMPROVE HUMAN
HEALTH FULL CIRCLE. FROM WORK
TO IDENTIFY AND CHARACTERIZE
UNDIAGNOSED DISEASES TO DEFINING
AND FACILITATING NEW TREATMENTS.
DR. WESTERNER AND I THINK THE
SCIENTISTS AND STAFF IN OUR
RESPECTIVE LABORATORIES ON OUR
CLINICAL TEAMS BOTH INSIDE AND
OUTSIDE THE NIDCR FOR THEIR
CLINICAL ROLES IN THIS GROUND
BREAK WOING WORK AND THANK YOU L
FOR YOUR ATTENTION.
>> THANK YOU SO MUCH. NOW WE'LL
HAVE OUR FINAL PLENARY. FOCUSED
ON DENTIST PUBLIC HEALTH AT
NIDCR. BY DOCTORS HOE SAM
>> HELLO, I AM THE DIRECTOR OF
THE FELLOWSHIP AT NIDCR. I'M
HAPPY TO PROVIDE A BRIEF
OVERVIEW OF DENTAL PUBLIC HEALTH
ADVANCEMENT AT THE INSTITUTE AND
TALK BRIEFLY ABOUT OUR
FELLOWSHIP PROGRAM. THEN, LOOK
DOCTOR LEAH WILL TALK ABOUT HER
RESEARCH EXPERIENCE. BEFORE I
BEGIN I WOULD LIKE TO SHARE TWO
POINTS ONE IS THAT NIDCR SINCE
THE BEGINNING HAS SUPPORTED
CLINICAL AND EVIDENCE-BASED
POPULATION HEALTH INTERVENTIONS
STARTING FROM SMALL SCALE AND
BASIC SCIENCE AND EXPANDING
THROUGH EPIDEMIOLOGY AND
DISSEMINATION. NUMBER TWO, ONCE
AN INITIATIVE ACHIEVES ITS
GOALS, OR PRIORITIES HAVE
CHANGED, THE WORK TYPICALLY
BECOMES INTEGRATED INTO THE
BROADER INSTITUTE STRUCTURE FOR
THE NEXT AGENDA TO BEGIN. IT
ALL BEGAN IN 1948 WHEN THE
DR. DEAN BECAME THE FOUNDING
DIRECTOR OF THE INSTITUTE.
DR. DEAN WAS A PUBLIC HEALTH
SCIENTIST AND EPIDEMIOLOGIST AND
HE LED THE FIRST LARGE U.S.
STUDY THAT CONFIRMED THE ROLE OF
FLUORIDE IN PREVENTING TOOTH
DECAY SHOWING A DECLINE IN TOOTH
DECAY UP TO 60% IN CHILDREN
AFTER THE IMPLEMENTATION OF THE
NATION'S FIRST COMMUNITY WATER
FLUORIDATION PROGRAM. A PICTURE
ON THE RIGHT SHOWS DR. LIE KINS
WAS ONE OF THE STAFF SCIENTISTS
TAKING PART OF THE STUDY. THE
NIDCR EARLY STUDY IN PER RIO
DONNAL DISEASE LED TO
DEVELOPMENT OF THE PERIODONTAL
INDEX IN 1956. THE INDEX BECAME
A VITAL TOOL FOR EPIDEMIOLOGISTS
TO MEASURE PERIODONTAL DISEASE
ACROSS POPULATIONS. BY 1964,
NIDCR RESEARCHERS HAD SHONE THAT
TOPICAL FLUORIDE COULD REDUCE
CARIES IN ANIMALS THAT LED TO A
SCHOOL BASED FLUORIDE GEL TRIAL
IN NEW YORK SHOWN THAT TOPICAL
FLUORIDE IS EFFECTIVE IN
REDUCING TOOTH DECAY UP TO 80%.
IN 1971 THE NATIONAL CARIES
PROGRAM WAS LAUNCHED BY FLSNIDCO
SPEED UP TOOTH DECAY EFFORTS.
MANY PREVENTATIVE MEASURES
INCLUDING DENTAL SEALANTS AND
FOOD SCREENING METHODS WERE
IDENTIFIED AND TESTED THROUGH
CLINICAL AND COMMUNITY TRIALS.
A GREAT EXAMPLE IS FLUORIDE
MOUTH RINSE DEMONSTRATION
PROJECT COMPLETED IN 1979.
DESIGNED SPECIFICALLY TO
COMPLEMENT COMMUNITY WATER
FLUORIDATION EFFORTS, RESULTS
SHOWED HIGH RISK CHILDREN HAD A
50% REDUCTION IN NEW CARIES AND
AS A RESULT, SCHOOL RINSE
PROGRAMS EXPANDED FROM 2-13
MILLION CHILDREN OUT OF A TARGET
POPULATION OF 25 MILLION.
REACHING 44 STATES IN 1985. AND
NIDCR CONDUCTED THE FIRST SCHOOL
CHILDREN SURVEY COMPLETED IN
1980 THE SURVEY WAS DESIGNED TO
ASSESS BASELINE DATA AND CHANGES
OVER TIME TO SEE IF THE
INTERVENTIONS WERE WORKING.
ABOUT ONE-THIRD OF THE CHILDREN
AT THE TIME WERE CARIES-FREE AND
ON AVERAGE EACH CHILD HAD A
THREE PERMANENT TEETH THAT WERE
DECAYED OR HAD FILLINGS. SEVEN
YEARS LATER THE SECOND SCHOOL
CHILDREN SURVEY SHOWED
SIGNIFICANT REDUCTION IN TOOTH
DECAY PREVALENCE AND SEVERITY.
WITH HALF OF THE CHILDREN WERE
CARIES-FREE AND THE AVERAGE THAT
THE NUMBER OF PERMANENT TEETH
THAT WERE DECAYED OR HAD
FILLINGS WAS TWO TEETH.
COMPARED TO THREE TEETH IN THE
FIRST SURVEY. IN 1986, NIDCR
CONDUCTED THE FIRST STUDY OF
ORAL HEALTH OF EMPLOYED ADULTS
AND OTHER ADULTS. THE VAST
MAJORITY OF PARTICIPANTS HAD
EXPERIENCED TOOTH DECAY AND HAD
PERRY OWE DONNAL DISEASE AND
CARRIES WERE COMMON IN OLDER
ADULTS.
THIS IS THE FIRST NATIONAL
SURVEY THAT MEASURED THIS IN
AMERICA. THE -- THE INSTITUTE
COLLABORATIVE GLOBAL ORAL HEALTH
EFFORTS INCLUDED THE
COLLABORATION OF SPECIFIC HEALTH
PROFILES, DEVELOPMENT OF THE
ORAL HEALTH RESEARCH AGENDA
INCLUDING VARIOUS TOPICS
INCLUDING GUM AND FLUORIDE. TWO
COLLABORATIVE STUDIES ON ORAL
HELL HEALTH SYSTEMS ACROSS
STUDIES AND THE LECTURE SERIES
THAT CONTINUES TO THIS DAY.
IN THE YEAR 2000 NIDCR LED AND
PROVIDE MUCH OF THE EVIDENCE
CITED IN THE ORAL HEALTH IN
AMERICA WORK OF THE SURGEON
GENERAL WHICH ESTABLISHED ORAL
HEALTH AS A NATIONAL HEALTH
PRIORITY. BIG THEMES WERE ORAL
HEALTH IS ESSENTIAL IN GENERAL
HEALTH AND ORAL HEALTH MEANS
MUCH MORE THAN HEALTHY TEETH AND
INCLUDE THE CRANIAL FACIAL
STRUCTURE AND THE PSYCHOSOCIAL
ASPECTS OF HEALTH. ORAL HEALTH
CANNOT BE ACHIEVED BY ALL
AMERICANS NONETHELESS THERE IS A
SILENT EPIDEMIC OF ORAL DISEASES
AFFECTING THE MOST VULNERABLE
INCLUDING CHILDREN, OLDER ADULTS
AND CERTAIN ETHNIC GROUPS.
TWENTY YEARS LATER NIDCR ALSO
LED THE SECOND ORAL HEALTH IN
AMERICA REPORT. SHOWING
CONTINUED IMPROVEMENT IN ORAL
HEALTH OUTCOMES INCLUDING FEWER
CAVITIES IN CHILDREN AND BETTER
TOOTH RETENTION IN OLDER ADULTS.
THE REPORT ALSO HIGHLIGHTED
ADVANCES AND TECHNOLOGY AND
SCIENCE SUCH AS DIGITAL TOOLS
AND DEEPER UNDERSTANDING OF THE
ORAL MICROBIOME HOWEVER,
DISPARITIES, ORAL HEALTH
DISPARITIES CONTINUED TO EXIST
AND EMERGE. TODAY, THE DENTAL
PUBLIC HEALTH RESEARCH
FELLOWSHIP EXPERIENCE STANDS AS
A LEGACY OF PUBLIC HEALTH
LEADERSHIP. THIS STARTED IN
1980 UNDER THE NATIONAL CARIES
PROGRAM AND EVOLVE OVER TIME IN
2016 WAS COMBINED WITH ORAL
HEALTH INFORMATICS WORKING WITH
THE NATIONAL LIBRARY OF MEDICINE
AND IN 2021 THE SCOPE WAS
BROADENED TO INCLUDE
COLLABORATION WITH NIH RESEARCH
PROGRAMS. SO THE FIRST YEAR IS
A DENTAL PUBLIC HEALTH RESIDENCY
FOLLOWED BY INTENSIVE RESEARCH
IN THE YEAR TWO AND THREE
WORKING ON A RESEARCH AGENDA
THAT BRIDGES GAPS BETWEEN PUBLIC
HEALTH AND BIOMEDICAL SCIENCES.
OUR RESEARCH AGENDA IS BROAD.
WITH EMERGING FOCUS ON ORAL
HEALTH AND SYSTEMIC HEALTH
CONNECTIONS. OVER THE PAST 45
YEARS, THIS FROM THE RESIDENCY,
60 GRADUATES JOINED THE FIELD AS
SUBJECT MATTER EXPERTS IN DENTAL
PUBLIC HEALTH. ABOUT HALF HAD
PURSUED CAREERS IN THE FEDERAL
GOVERNMENT PRIMARILY IN THE
MILITARY AND THE OTHER HALF
ENTERED ACADEMIA OR OTHER
SECTORS OR CONTINUED THEIR
EDUCATION. OVER THE YEARS THE
TRAINEES CONTINUED TO TRAVERSE
THE AGENDA USING DATA FROM
VARIOUS SOURCES INCLUDING THE
MILITARY, CMS, COMMERCIAL
SERVICES, AND OTHER FEDERAL AND
NATIONAL PROGRAMS. IN GENERAL,
WE USE A CROSS-SECTIONAL
LONGITUDINAL DATA WHICH NOT ONLY
ALLOW US TO INVESTIGATE
ASSOCIATION BUT ALSO TIME BASED
PATTERNS AND POSSIBLE CAUSE AND
EFFECT RELATIONSHIPS. THESE ARE
OUR CURRENT COLLABORATIONS
COVERING VARIOUS TOPICS
INCLUDING TASTE AND SMELL, SLEEP
HEALTH, COGNITIVE HEALTH, CANCER
AND ORAL CANCER AND ALCOHOL USE
DISORDER. THESE COLLABORATIONS
ALLOW US TO ASK NEW QUESTIONS
AND BRING ORAL HEALTH INTO AREAS
WHERE IT HASN'T BEEN
TRADITIONALLY INCLUDED AND WITH
THAT, THANK YOU VERY MUCH, NEXT
THE DOCTOR TO TALK ABOUT HER
RESEARCH EXPERIENCE.
>> GREAT, THANK YOU FOR THAT
LOVELY INTRODUCTION AS WELL. I
AM DR. LEAH AND THANK YOU FOR
THE OPPORTUNITY TO SHARE MY
EXPERIENCES OVER THE LAST THREE
YEARS. BEFORE WE GET INTO THAT
LET ME TELL YOU ABOUT HOW WE GOT
HERE. PRIOR TO JOINING NIH I
CARED FOR PATIENTS IN MARYLAND
AND PENNSYLVANIA. AND IT WAS A
PRIVILEGE TO CARE FOR PATIENTS
AND PEOPLE AT SOME OF THE WORST
TIMES IN THEIR LIVES AND THROUGH
THIS I HEARD SIMILAR STORIES
FROM PATIENTS ABOUT THEIR
EXPERIENCES WITH US AND WITH THE
HEALTH CARE SYSTEM. SOME OF
WHICH ARE SUMMARIZED IN THE BLUE
BOX HERE. I DECIDED TO SEE IF I
COULD TRANSLATE THIS APPEARANCE
FROM PATIENT TO POPULATION AND
BACK AGAIN CONTRIBUTING TO
SYSTEMS LEVEL CHANGE. SO ONE
THING I OBSERVED WHILE COVERING
EMERGENCY DEPARTMENTS DURING THE
BEGINNING OF THE COVID-19
PANDEMIC IS ALL OF OUR PRACTICE
PATTERNS CHANGED WITH A SHIFT
TOWARDS MANAGEMENT OF DENTAL
PROBLEMS AND I WONDERED IF THIS
WAS WHAT I WAS OBSERVING AT THE
HOSPITALS I HAVE WO -- I WAS WO
AT BUT ALSO IN THE POPULATION AS
WELL.
AND WAS THIS FOR CONTINUED
INVESTIGATION AND INTERVENTION
SO THE ANSWER TO THIS QUESTION,
WE LOOKED AT THE NATIONAL
HOSPITAL AM BUT LA STORY MEDICAL
CARE SURVEY TO LOOK AT
PRESCRIPTIONS FOR PATIENTS
PRESENTING U.S. EDS.
WE FOUND THEY WERE MOST
PRESCRIBED IN 2020 AS EXPECTED.
BUT THE VAST MAJORITY OF THEM
WERE NONSTEROIDAL
ANTI-INFLAMMATORIES AS OPPOSED
TO OPIOIDS, THINGS LIKE ADVIL
THAT CARRY LOWER RISKS THAN
OPIOIDS. ANTIBIOTICS WERE MOST
COMMON IN 2020 AS WELL BUT NOT A
HUGE DIFFERENCE IN THE
PROPORTION OF THE ANTIBIOTIC
THAT WE OBSERVED OVER TIME SO
THIS SUGGESTS AN OPPORTUNITY TO
FURTHER REDUCE THE NEED FOR BOTH
THE ED VISITS AT THEIR CAUSE AND
ALSO THE UNINTENDED CONSEQUENCES
OF THE EXPOSURES TO MEDICATIONS
SUCH AS ANTIBIOTICS AND OPIOIDS
AND THESE FINDINGS ARE PUBLISHED
IN THE JOURNAL OF HEALTH
DENTISTY. ANOTHER GROUP I CARED
FOR WHERE PEOPLE WERE UNDERGOING
ACTIVE CANCER TREATMENT. I SAW
HOW SMALL ORAL HEALTH PROBLEMS
COULD BALLOON INTO COSTLY AND
UNNECESSARILY MORBID CONDITIONS
IF UNTREATED OR TREATED WITHOUT
CONSIDERATION OF THE PATIENTS
HISTORY. I WONDERED IF WE COULD
LOOK AT THE ORAL HEALTH PROBLEMS
AMONG THOSE WITH HAEMATOLOGIC
CONDITIONS. AND THIS WAS WITH
INVESTIGATORS FROM THE NIH
CLINICAL CENTER AND THE NATIONAL
CANCER INSTITUTE. THIS STUDY
HERE WE USED THE DATA FROM AN
ONGOING HISTORY OF PATIENTS WITH
A HISTORY OF STEM CELL
TRANSPLANTATION TO ASSESS
CLINICAL AND PATIENT REPORTED
OUTCOMES OVER TWO YEARS. WE
FOUND REDUCTIONS IN ORAL HEALTH
STATUS WORKED WITH PAIN
SPECIFICALLY AND DECREASED
QUALITY OF LIFE EVEN TWO YEARS
AFTER TRANSPLANT. AND THIS
PRESENTED AN OPPORTUNITY FOR
TEAM CARE THROUGHOUT THE
SURVIVORSHIP PERIOD PARTICULAR
WHEN PATIENTS TRANSITION BACK
INTO THE COMMUNITY CARE AND OUT
OF TRANSPLANT CENTERS. AND
THESE FINDINGS ARE PUBLISHED IN
THE GENERAL DENTAL RESEARCH.
AND SO THAT LAST PROJECT GREW
INTO ANOTHER PROJECT WITH
EXISTING COLLABORATORS. HERE WE
ARE ANALYZING DATA FROM THE SAME
COHORT I MENTIONED BEFORE, TO
SPECIFICALLY EXAMINE PATIENTS
WITH ORAL CHRONIC GRAPHS VERSUS
HOST DISEASE AS WE HEARD TODAY,
CHRONIC GRAPHS VERSUS HOST
DISEASE IS AN IMMUNE MEDIATED
CONDITION THAT CAN OCCUR IN
PATIENTS FOLLOWING STEM CELL
TRANSPLANT THIS CAN LEAD TO
SIGNIFICANT PAIN, DISCOVERT AND
REDUCED QUALITY OF LIFE. IT CAN
ALSO BE DIFFICULT AND EXPENSIVE
TO TREAT PARTICULARLY IN
PATIENTS WHO ARE NOT RESPONSIVE
TO STEROIDS AND HERE WE HAVE THE
BURDEN AND QUALITY OF LIFE AT
THE TIME OF ORAL DIAGNOSIS AND
PRELIMINARY FINDINGS SHOW THAT
QUALITY OF LIFE ARE ALL
OBSERVED. AND LONGITUDINAL
ANALYSES ARE ONGOING. AND WITH
THAT, I WILL THANK YOU AGAIN FOR
THE OPPORTUNITY TO PRESENT AND
FOR YOUR TIME AND CONSIDERATION.
THANK YOU VERY MUCH.
>> THANK YOU, EVERYONE, FOR THE
GREAT MANY SYMPOSIUM.
COUNCILMEMBERS, DO YOU HAVE
QUESTIONS? HEARING NONE, WE ARE
ABOUT FIVE MINUTES BEHIND. SO
MY SUGGESTION IS THAT WE BREAK
UNTIL 1:05. DOES THAT SOUND
GOOD TO EVERYONE? OKAY. ALL
RIGHT. OKAY. UNTIL 1:00.
OKAY? AND THEN WE'LL START BACK
ON TIME. THANKS, EVERYONE.
>> WELCOME, BACK, EVERYONE TO,
THE OPEN SESSION COUNCIL AGAIN.
WE'RE GOING TO START WITH
CONCEPT CLEARANCES: JUST A BRIEF
BACKGROUND ON CONCEPT
CLEARANCES, THEY REPRESENT AN
EARLY PLANNING STAGE FOR
POTENTIAL (ECHO) POTENTIAL NIDCR
AND TRANS-NIH. THEY COVER
MULTIPLE INITIATIVES AND NOTICES
OF FUNDING OPPORTUNITIES OR
NOFOS. THROUGH THE CONCEPT
CLEARANCE PROCESS NIDCR RECEIVES
INPUT FROM THE NATIONAL ADVISORY
COUNCIL REGARDING THE MERITS OF
THE CONCEPTS. COUNCILMEMBERS
ARE ASKED TO SERVE AS PRIMARY
AND SECONDARY REVIEWERS.
FOLLOWING THE PRESENTATION BY
NIDCR STAFF THERE'LL BE A
DISCUSSION AND A VOTE AS A
BASIS. TODAY WE ARE PLEASED TO
PRESENT THREE CONCEPTS THAT HAVE
RECEIVED APPROVAL BY THE NIH
LEADERSHIP FOR IMMEDIATE COUNCIL
CLEARANCE. THE FIRST WILL BE BY
THE DR. MCGIRL.
>> THANK YOU, YASMIN, CAN
EVERYONE SEE MY SLIDES?
>> YES.
>> GREAT, THANK YOU SO MUCH FOR
THAT. TODAY I'M HERE TO TALK TO
YOU ABOUT TWO TRAINING AWARD
CONCEPTS. THE R 90
INSTITUTIONAL TRAINING AWARD AND
THE UE 5 MENTORING AWARD BUT
FIRST I WANT TO UPDATE YOU ON
SOME CHANGES TO THE NIH CONCEPT
CLEARANCE AND NOFO DEVELOPMENT
PROCESS ESPECIALLY TO CALL YOUR
ATTENTION TO ONE IMPORTANT
ADDITION. WOULD YOU PLEASE MUTE
THE ROOM? THANK YOU. AFTER
NIDCR COMES UP WITH AN IDEA FOR
AN NOFO, WE NOW WRITE A
DESCRIPTION A VERY BRIEF
DESCRIPTION CALLED A FORECAST
FOR APPROVAL BY NIH LEADERSHIP.
AND WHEN IT'S APPROVED THAT
FORECAST GETS PUBLISHED AT
GRANTS.GOV NOW THIS ADDED
FORECAST STEP HAS PLANNED FOR
SEVERAL YEARS AND WILL BRING US
INTO ALIGNMENT WITH HOW OTHER
FEDERAL AGENCIES MANAGE THEIR
NOTICES OF FUNDING OPPORTUNITY
BUT MOST IMPORTANTLY FOR THE
EXTRAMURAL COMMUNITY IS THAT IF
YOU, YOU CAN SEEN UP ON
GRANTS.GOV TO RECEIVE
NOTIFICATION E-MAILS ABOUT
FORECASTS NOW REMEMBER FORECASTS
ARE PLANNED BUT NOT YET OFFICIAL
GRANT OPPORTUNITIES. SO PLEASE
GO TO GRANTS.GOV AND SIGN
YOURSELF UP. ONCE THE FORECAST
HAS BEEN APPROVED THE NEXT STEP
IS TO BRING IT TO CONCEPT, TO
COUNCIL FOR A CONCEPT CLEARANCE
WHICH IS THE STAGE WE'RE AT
RIGHT NOW AND ONCE COUNCIL
APPROVES OF A CONCEPT, THEN
NIDCR WILL WRITE UP THE NOFO OR
NOFOS AS THE CASE MAY BE AND NIH
WILL WILL APPROVE THE DRAFT
PRIOR TO ITS PUBLICATION.
AND THIS ENTIRE PROCESS FROM
START TO FINISH MAY TAKE UP TO A
YEAR. NOW THE FIRST CONCEPT IS
THE T 90 R 90 INDECISION
CONSTITUTIONAL TRAINING AWARD.
THE NIH HAS SET UP A GOAL TO
REDUCE THE NUMBERS ISSUED.
WE'RE TAKING THE LEAD TO TAKE
OUR T 90/R 90 NOFO AND REVISING
AN IT A BIT SO IT CAN BE A
PARENT TYPE OF NOFO THAT CAN
SERVE MULTIPLE INSTITUTES OR
CENTERS. NIDCR ISSUES BY FAR
THE MOST T 90 AWARDS OF ALL OF
THE NIH ICS AND SO WE REALLY
WANT THE PROGRAM TO CONTINUE BUT
THIS MULTIIC APPROACH DOES MEAN
THAT THE T 90/R 90 NOFO WILL BE
WRITTEN WITHOUT SPECIFYING A
VERY SPECIFIC MISSION AREA THAT
IS SPECIFIC TO AN IC. WE PLAN
TO USE THE PARENT T32 AS THE
BLUEPRINT FOR THE T 90 PORTION
AND THE T32 IS A ROBUST NOFO IT
INCLUDES BEST PRACTICES TRAINING
FOR MENTORS, TRACKING OUTCOMES,
IDENTIFYING ROOT CAUSES WHEN
THERE'S LESS THAN OPTIMAL
TRAINEE OUTCOMES AND IT ALSO
ASKS TO INCORPORATE CHANGES TO
ADDRESS THOSE CAUSES IT ALLOWS
PROGRAMS TO INCLUDE JAB
SHADOWING AND INTERNSHIPS AS
APPROPRIATE THIS WILL BE
CONSIDERED AS A REISSUE. THE
GOOD NEWS ABOUT THIS IS THAT
THIS ENSURES THAT NIDCR CURRENT
GRANTEES CAN APPLY AS RENEWALS
AS OPPOSED TO BRAND NEW AWARDS.
SO THEY GET CREDIT FOR ALL THEIR
PRIOR SUCCESS. AND A PLANNED
PRE-APPLICATION WEBINAR WILL BE
HELD TO EXPLAIN TO POTENTIAL
NIDCR APPLICANTS WHAT NIDCR IS
LOOKING FOR THE HALLMARKS OF THE
T 90/R 90 REMAIN EXACTLY THE
SAME. THE PURPOSE IS TO BUILD A
ROBUST BIOMEDICAL WORKFORCE BY
TRAINING GRAD STUDENTS INCLUDING
THESE ENROLLED IN DUAL DEGREE
PROGRAMS LIKE DENTAL SCIENTISTS
AS WELL AS POSTDOCS AND CLINICAL
SCIENTISTS. WE HAVE THE PROGRAM
THAT SUPPORTS U.S. CITIZENS AND
GREEN CARD HOLDERS. BUT UNIQUE
TO THE T 90 IS THE, TO THIS
MECHANISM IS THE R 90 RESEARCH
EDUCATION PROGRAM. THAT ALLOWS
SUPPORT FOR NON-CITIZENS WHO
HOLD U.S. VISAS AND ARE TRAINING
HERE IN THE U.S. NOW ONE
ADVANTAGE OF IT BEING A MULTIIC
NOFO IS THIS WILL BE ISSUED
REGULARLY MEANING THERE'LL BE
LIKE ONE DUE DATE PER YEAR BUT
NO PAUSES WHEN THERE'S YEARS
WHERE THERE'S NO ACTIVE NOFO TO
APPLY FOR AND THAT ALIGNS WITH
THE RECOMMENDATION MADE LAST
YEAR BY THE ORAL HEALTH RESEARCH
WORKFORCE WORKING GROUP. THE T
90/R 90 HAS SERVED NIDCR REALLY
WELL, THE R 90 COMPONENT ALLOWS
US TO SUPPORT THE RESEARCH
TRAINING OF DENTISTS, PEOPLE WHO
RECEIVE THEIR DENTAL DEGREES
FROM FOREIGN INSTITUTIONS, AND
THAT HAS BEEN A VITAL PIPELINE
LEADING TO INDEPENDENT DOC
RESEARCHERS. THE TRAINEES ARE
SUCCESSFUL AS YOU CAN SEE ON
THIS CHART. AND WHILE I HAVE TO
ADMIT I'D LIKE TO SEE MORE R 90
TRAINEES SUBMIT TO THE NIH. WE
ARE TRULY DELIGHTED THAT THOSE
WHO DO ARE JUST AS SUCCESSFUL AS
OTHER TRAINEES AND IMPORTANTLY,
THEY SUBMIT TO NIDCR. I SHOULD
MENTION TOO THAT ANOTHER
RESEARCHER OUTCOME IS THAT T 90,
R 90 TRAINEES ACCEPT TEACHING
RECIPIENTS AS WELL. AND NOW
WE'LL HEAR FROM COUNCIL STARTING
WITH DR. PAUL AND DR. LOUISA TO
TALK ABOUT WHAT THEIR THOUGHTS
ARE ON THIS MECHANISM.
>> I AM VERY SORRY, THIS IS
JACQUES. I BELIEVE I AM IN
CONFLICT. CAN YOU --
>> YOU DON'T NEED TO BE LEFT
OUT. YOU JUST DON'T COMMENT ON
IT. THIS IS OPEN.
>> OKAY. THANK YOU.
>> SURE.
>> ALL RIGHT. MICHELE, THANK
YOU. I WILL BE BRIEF BECAUSE MY
COMMENTS ARE VERY SIMILAR TO
YOUR PRESENTATION. I KNOW IT'S
A FORMALITY HERE. THE REISSUE
OF THIS T 90/R 90 MECHANISM
PRESENTS A SOUND INITIATIVE THAT
REINFORCES THE INSTITUTE'S
COMMITMENT AS YOU MENTIONED TO
DEVELOPING WELL-TRAINED DENTAL
ORAL AND CRANIOFACIAL WORKFORCE.
THE CONCEPT BUILDS ON THE
SUCCESS OF THE PREVIOUS T 90 AND
R 90 PROGRAMMINGS. WHILE
ALIGNING WITH THE BROADER NIH
DIRECTIVE TO STREAMLINE THE
PROCESS AND AS YOU MENTION THIS
WOULD SERVE THEN AS THE PARENT
ANNOUNCEMENT. THE CONCEPT
ADDRESSES KEY QUESTIONS RELATED
TO THE SCIENTIFIC SCOPE
INSTITUTIONAL FLEXIBILITY AND
TRAINING ELIGIBILITY IT OUTLINES
OUT THE T 90/R 90 MECHANISM CAN
ADAPT TO EVOLVING PRIORITIES
INCLUDING AI AND
INTERDISCIPLINARY RESEARCH WHILE
PROVIDING APPROPRIATE MENTORSHIP
AND TRAINING ENVIRONMENTS.
HOWEVER, AS THIS CONCEPT PLANS
MOVE FORWARD TO BECOMING A
FUNDING OPPORTUNITY, ADDITIONAL
DETAILS WILL NEED TO BE ADDED.
SPECIFICALLY MORE CLARITY ON THE
REVIEW CRITERIA, EXPECTATIONS
FOR MENTORING OUTCOMES, METRICS
FOR TRAINING, TRANSITION, WOULD
STRENGTHEN THAT AND MICHELE DID
MENTION THAT, THAT THAT'S WHAT
WILL HAPPEN AS IT KIND OF
MIRRORS THE T IF 2. OVERALL I
SUPPORT THE MECHANISM. I THINK
THE CONTINUATION IS NEEDED FOR
EXTENDING THE RESEARCHERS.
IT'S AN INVESTMENT IN OUR
FUTURE. BIOMEDICAL RESEARCH.
AND WILL BENEFIT ALL OF THE
NIDCR AND THE BROADER SCIENTIFIC
COMMUNITY AS WELL. SO I THINK
IF AA -- THE APPROVAL IS
WARRANTED WITH THE UNDERSTANDING
THAT THESE REFINEMENT WILL FIND
THEIR WAY INTO THE FINAL
MECHANISM. THANK YOU.
>> THANK YOU. THANKS, PAUL,
LOUISA, WOULD YOU LIKE TO
DISCUSS SOME THINGS AS WELL AND
>> JUST A FEW THINGS, FIRST OF
ALL THANK YOU SO MUCH
DR. MCGUIRL FOR PUTTING THIS
TOGETHER. I AGREE WITH
EVERYTHING THE DOCTOR SAID. I
THINK THIS IS REALLY AN
ESSENTIAL PROGRAM MECHANISM TO
CONTINUE AND I ALSO THINK THAT
NOW MORE THAN EVER WE HAVE TO
THINK ABOUT THE LONG GAME AND
THAT IS TO CONTINUE TO SUPPORT
THE DEVELOPMENT OF YOUNG
SCIENTISTS AND RESEARCHERS WHO
WILL CARRY THE MISSION FORWARD.
THEY NEED OUR SUPPORT NOW. MORE
THAN EVER. I JUST HAVE A FEW
SUGGESTIONS, ONE, OF COURSE I
THINK YOU'RE ALREADY TAKING THIS
INTO ACCOUNT I REALLY OF COURSE
HAVING BEEN INVOLVED WITH THE
WORKING GROUP ON THE ORAL HEALTH
RESEARCH WORKFORCE REPORT HAVING
BEEN INVOLVED WITH THAT, I
REALLY LIKE IT THAT YOU'RE
TAKING THAT INTO ACCOUNT AND
TAKING SOME OF OUR SUGGESTIONS.
I APPRECIATE THAT THERE'LL BE NO
PAUSES THIS I THINK IS A REALLY
DIFFICULT SITUATION WHEN PAUSES
OCCUR SO THAT'S WONDERFUL GOING
FORWARD I ALSO HOPE YOU'LL
UTILIZE SOME OF THE OTHER
SUGGESTIONS THAT ARE IN THERE
AND I KNOW YOU TALKED A LITTLE
BIT ABOUT HOW THEY'VE BEEN
SUCCESSFUL AND I KNOW THAT NIDCR
DOES COLLECT DATA ON TRAINEES
BUT I THINK WE NEED VERY
LONG-TERM DATA. AND ONE THING
THAT CAME UP IN OUR WORKING
GROUP IS THAT WE DON'T HAVE MUCH
DATA ON THOSE THAT LEAVE, YOU
KNOW, AND WHO DON'T CONTINUE IN
RESEARCH CAREERS OR EVEN
ACADEMIC CAREERS. WE KIND OF
LOSE TRACK OF THEM AND I
UNDERSTAND THIS IS VERY
DIFFICULT SOMETIMES TO TRACK
DOWN THOSE INDIVIDUALS BUT I
THINK WE CAN LEARN A LOT FROM
THEM. AND MAY BE ABLE TO
MITIGATE SOME OF THAT LOSS OF
TRAINEES BECAUSE THEY ARE A
PRECIOUS RESOURCE SO IF WE LEARN
WHY PEOPLE ARE LEAVING MAYBE WE
CAN DO SOMETHING ELSE AND IN OUR
REPORT WE DISCUSS HOW THIS
TRANSITION PERIOD IS VERY
DIFFICULT FOR TRAINEES SO I
UNDERSTAND SOME OF THAT, YOU
KNOW, MITIGATING THE LOSS AND
ASSISTANCE AND MENTORING THROUGH
THE TRANSITION PERIODS COULD BE
NIDCR SPECIFIC BUT I HOPE YOU'LL
CONSIDER IT FOR THE NIDCR
SPECIFIC PORTION OF THIS. WHICH
I UNDERSTAND WILL BE DIFFERENT
THAN THE PARENT NOFO BUT I'M
VERY SUPPORTIVE AND THANK YOU.
>> OKAY, LOUISA, I THINK THOSE
ARE GREAT SUGGESTIONS AND I
AGREE WITH YOUR ASSESSMENT THAT
THEY'RE NEEDED TO MAKE THE
PROGRAM EVEN MORE SUCCESSFUL.
ARE THERE OTHER COMMENTS AND
DISCUSSION BY THE
COUNCILMEMBERS? OKAY? WELL
HEARING NONE I WILL HAND IT OVER
TO YASMIN TO CALL THE VOTE.
>> YES, THANK YOU DR. MCGUIRL.
WOULD A MEMBER OF COUNCIL LIKE
TO MAKE A MOTION TO APPROVE THIS
CONCEPT? EXCEPT DR. NOR.
>> SO MOVED, PAUL.
>> SECOND.
>> THANK YOU, ALL IN FAVOR. ANY
OPPOSED? THANK YOU WE'LL MOVE
TO THE NEXT COUNCIL CONCEPT
PRESENTED BY DR. MCGUIRL AS
WELL. OKAY, YOU'RE MUTED.
DR. MCGUIRL YOU'RE MUTED.
>> I JUST GOT IT UNMUTED. THANK
YOU, I APPRECIATE IT. HOPEFULLY
YOU CAN SEE THESE SLIDES AS
WELL. THIS IS ANOTHER REISSUE
CONCEPT THAT WE'RE ASKING
COUNCIL TO APPROVE. IT'S THE UE
5 MENTORING NETWORK AWARD. AND,
AGAIN, THIS WILL BE ISSUED AS A
PARENT OR MULTIIC AWARD AND THE
CONTENT WHICH WAS INITIALLY
FOCUSED ON PROMOTING DIVERSITY
WILL BE REVISED TO ALIGN WITH
NIH PRIORITIES. THE UE 5
PURPOSE IS TO PROVIDE SKILLS,
DEVELOPMENT OPPORTUNITIES, AS
WELL AS ONE-ON-ONE MENTORING TO
AN ANNUAL COHORT OF TRAINEE TO
HELP THEM SUCCEED IN BECOMING
INDEPENDENTLY FUNDED NIH
INVESTIGATORS.
THESE COHORT OF TRAINEES, THESE
MENTEES CAN BE EARLY CAREER
FACULTY, POSTDOCS, CLINICIAN
SCIENTISTS, OR GRADUATE
STUDENTS, NOW GRAD STUDENTS WERE
IMPORTANT TOPICS FOR UE 5 NOFOS
ISSUED BY OTHER ICS AND SO THIS
PARENT TYPE WILL HAVE TO BE
BROADER THAN WHAT NIDCR HAD
INITIALLY INCLUDED IN THEIR
NOFO.
BUT THIS WILL MEET THE NEED AND
AGAIN, WE EXPECT THIS TO BE AN
ACTIVE NOFO EVERY YEAR PROBABLY
WITH ONE DUE DATE PER YEAR. THE
UE 5 HAS BEEN VERY SUCCESSFUL
FOR NIDCR AND WE CONTINUE TO
CONTINUE OUR FOCUS ON EARLY
CAREER FACULTY.
AND LATE STAGE TRAINEES OVER
GRADUATE STUDENTS WHO ARE BEING
SERVED BY OUR OTHER TRAINING
MECHANISMS. AND WE PLAN TO HOLD
A PRE-APPLICATION WEBINAR TO
MAKE ITS SPECIFIC INTERESTS
KNOWN AS SOON AS THE NOFO IS
RELEASE THIS HAD TYPE OF
MENTORING THE THE UE 5 PROVIDES
IS JUST TRULY MAKING A HUGE
DIFFERENCE.
DATA FROM A PRIOR UE 5 MENTORING
AWARD SHOWS JUST HOW EFFECTIVE
THAT MENTORING CAN BE.
LOOKING AT THE YEARS 2020-2023,
FROM A RECENT AWARD. YOU CAN
SEE THAT ALL OF THEM WERE
SUCCESSFUL, RIGHT? MOST OF THEM
WERE VERY GOOD THEY APPLIED,
NEARLY ALL OF THEM APPLIED FOR
FUNDING AND THEIR SUCCESS RATE
WAS TRULY REMARKABLE. SO WE
THINK YOU NEED THIS EXTRA PUNCH,
THIS ADDED MENTORING STEP TO BE,
TO JUST INCREASE THE SUCCESS OF
OUR TRAINEES IN BECOMING
INDEPENDENTLY FUNDED. RESEARCH
INVESTIGATORS AND SO WITH THAT,
WE'RE ASKING THE COUNCIL TO
APPROVE THE REISSUE OF THE UE 5
MENTORING NETWORK AWARD AND
DR. JACQUES NOR AND DR. AMY SLEP
WILL LEAD OUR DISCUSSION.
>> THANK YOU DR. MCGUIRL, I'M
HAPPY TO PROVIDE SOME COMMENTS
ABOUT THE UE 5 THIS CONCEPT IS
FOCUSED ON THE DEVELOPMENT OF
STRUCTURED NETWORKS TO SUPPORT
THE CAREERS OF NEW
INVESTIGATORS.
THE REISSUING OF THIS CONCEPT
SHOWS A CLEAR UNDERSTANDING OF
THE ENVIRONMENT AND A STRONG
COMMITMENT TO THE CRANIOFACIAL
RESEARCH IN THE UNITED STATES.
THE GAP TO FILL IS THE OBSERVED
LACK OF STRUCTURED PROGRAMS
FOCUSED ON SUPPORTING THE
CAREERS OF THE RESEARCHERS.
THIS UE 5 IS RESPONSIVE TO THE
RECOMMENDATIONS OF OUR RECENT
REPORT DEVELOPED BY THE NIH BY A
MEDICAL WORKFORCE WORKING GROUP
THAT IDENTIFIED THE NEED TO GROW
THE DOC RESEARCH WORKFORCE AS A
HIGH PRIORITY. IT'S FOCUS FROM
A POSTDOC POSITION IN THE AWARD
OF THE FIRST GRANT FROM THE NIH
OR EQUIPMENTE CONSIST FOSTERED
THROUGH THIS NETWORK WILL
INVOLVE MENTORS WITH THE GOAL OF
EXPANDING AND REACHING SUPPORT
RECEIVED BY EARLY CAREER
INVESTIGATORS AND ENHANCE THEIR
ABILITY TO SUBMIT COMPETITIVE
GRANTS APPLICATIONS.
PRIOR FUNDING THROUGH THIS UE 5
SUPPORT AND THE HIGHLY
SUCCESSFUL FUTURE PROGRAM IN THE
FIRST CYCLE THE PROGRAM PROVIDED
MENTORSHIP AND SUPPORT TO THE
CAREER PROGRESSIONS OF MORE THAN
50 EARLY STAGE DOC
INVESTIGATORS. AS DR. MCGUIRL
JUST SHOWED ABOUT 70% OF THE
PARTICIPANTS BETWEEN 2020-23
RECEIVED NIH FUNDING WHICH IS
TRULY REMARKABLE. IN
CONCLUSION, THE IMPACT AND
SIGNIFICANCE OF SUPPORTING
NATIONWIDE MENTORING NETWORKS
FOR EARLY CAREER INVESTIGATORS
ARE TRULY EXCEPTIONAL. INDEED
THE FUTURE OF THE CRANIOFACIAL
RESEARCH RELIES ON EFFECTIVE
MENTORING OF POST-DOCTORAL
FELLOWS AND JUNIOR FACULTY IN
INTENSIVE CAREERS. AS SUCH THE
REISSUING OF THIS UE 5 IS TIMELY
AND HAS MY HIGHEST, MY STRONGEST
AND UNCONDITIONAL SUPPORT.
THANK YOU.
>> THANKS. DR. SLEP, WOULD YOU
LIKE TO ADD?
>> I DON'T KNOW HOW I CAN ADD TO
THAT. THAT WAS INCREDIBLY
ELOQUENT. SO I CONCUR THAT THIS
IS INCREDIBLY IMPORTANT, VERY
TIMELY AND THAT OUR WORKFORCE IS
INCREDIBLE ANYWAY WITH SO MANY
PRESSURES THAT ARE KIND OF
ALIGNING TO EITHER PULL THEM
INTO PRIVATE PRACTICE OR PULL
THEM INTO OTHER AREAS OF
RESEARCH. AND THIS KIND OF
NATIONAL MENTORING IS CRITICAL
AND IF THIS ISN'T REISSUED I
WOULD BE SCARED. AND SO I THINK
IT'S... I AGREE IT'S VERY, VERY
TEAM -- TIMELY AND IMPORTANT
THAT IT GET REISSUED.
>> THANK YOU, ANY DISCUSSION
FROM THE OTHER COUNCILORS.
HEARING NONE, I WILL TURN IT
OVER TO DR. SHIR RAZI.
>> THANK YOU, WOULD ANY MEMBER
OF COUNCIL LIKE TO MAKE A MOTION
TO APPROVE THIS CONCEPT?
>> SO MOVED, JACQUES.
>> WOULD SOMEONE LIKE TO SECOND
THE MOTION? SECOND?
>> I WILL SECOND THAT.
>> THANK YOU. ALL IN FAVOR?
ANY OPPOSED? THANK YOU SO MUCH.
THE NEXT CONCEPT WILL BE
PRESENTED BY DR. BILL ELWOOD WHO
IS THE CHIEF OF BEHAVIORAL AND
SOCIAL SCIENCES RESEARCH BRANCH
IN THE DIVISION OF EXTRAMURAL
RESEARCH AT THE NIDCR.
DR. ELWOOD, PLEASE SHARE YOUR
PRESENTATION.
>> YES, MA'AM, DR. SHIRAZ ZEE,
WOOPS. FORGIVE ME. EE,
WOOPS. FORGIVE ME. ,
WOOPS. FORGIVHOOPS. FORGIVE M
GOAL FOR THIS CONCEPT IS PARTLY
INSPIRED BY THE NIH MOVEMENT
TOWARD FEWER NOFOS WITH MULTIPLE
PURPOSES AND THE NIDCR STRATEGIC
PLAN WHICH IS BACK ONLINE AGAIN
IF YOU HAVEN'T SEEN IT.
SPECIFICALLY, IT'S TO INVITE
APPLICATIONS THAT PROPOSE
RESEARCH THAT REFLECTED ON ALSO
FACTORS FOR HUMAN BEHAVIORS AND
HOW THOSE BEHAVIORS HAVE AN
IMPACT ON DOC AND ORAL SYSTEMIC
HEALTH OUTCOMES. AND YOU CAN
SEE THE MANY DIFFERENT KINDS OF
CAUSAL HYPOTHESES THAT CAN LOOK
AT THE PROPOSAL. WE HAVE A VERY
FINE THIS MIGHT HELP MANY THAT
REGARD. IT MAY NOT BE NECESSARY
FOR CAUSATION. THERE'S CAUSAL
INFLUENCE AND CAUSAL
EXPLANATION. SO HOW DOES OUR
STRATEGIC PLAN RELATE TO THIS
CONCEPT? THERE YOU GO, MULTIPLE
FACTORS, BIOLOGICAL,
ENVIRONMENTAL, COMMERCIAL, AND
DOC HEALTH AND ORAL SYSTEM.
WHILE I LET YOU READ THAT, I
WILL POINT OUT THE ANCIENT PHOTO
ON THE RIGHT WHICH REMINDS ME OF
TIME I SPENT IN SOUTH FLORIDA
WHEN I MET A NUMBER OF PEOPLE
WHO HAD OF A CERTAIN AGE WHO HAD
BEEN EXPOSED TO DDT. NOT ONLY
HAD THEY BEEN EXPOSED BUT THEY
FOUND GREAT DELIGHT IN DANCING
DOWN THE STREETS BEHIND THE
TRUCKS AS THEY WENT THROUGH THE
NEIGHBORHOODS. THAT WAS BEFORE
WE KNEW THE NEGATIVE EFFECTS FOR
AN UNDERSTATEMENT OF DDT SO
THERE'S ALSO ENVIRONMENTAL
EXPOSURES THAT COULD BE PART OF
THIS PROJECT. I ALSO MIGHT
POINT OUT THAT PROJECTS COULD BE
SPECIFICALLY SECONDARY DATA.
THE D DS HUB, THE BEHAVIORAL
RISK FACTOR SURVEILLANCE STUDY
AT C DC.
THE HEALTH AND RETIREMENT SURVEY
SUPPORTED BY NIA AT THE
UNIVERSITY OF MICHIGAN. THOSE
ARE ONLY THREE EXAMPLES. BUT
THERE ARE ACTIVE AND PAST NIDCR
FUNDED PROJECTS WHOSE DATA MAY
NOT HAVE BEEN USED TO GENERATE
KNOWLEDGE TO THE EXTENT
POSSIBLE. FOR EXAMPLE, THIS,
YOU CAN SEE HERE THAT, THIS
FIRST PROJECT SUGGESTS THAT
CLINICIANS COULD BENEFIT FROM
TRAINING. THE SECOND PROJECT IS
FROM DONALD CHI. ADDITIONAL
GAPS IN OPPORTUNITIES. WE'VE
TALKED A LOT TODAY ABOUT
MULTIPLE CHRONIC CONDITIONS.
AND I WILL ALSO POINT OUT THAT
OUR HISTORY HAS BEEN
INTRINSICALLY TIED TO MILITARY
HEALTH SINCE OUR BEGINNING. AND
THERE ARE, WE ARE UNIQUELY
POISED TO LEAD A PROJECT ON
MILITARY READINESS, DOC HEALTH
AND THAT MAY INCLUDE OTHER ICS
IN THE DEFENSE DEPARTMENT, IT
MAY NOT. BUT IT'S REALLY
IMPORTANT WORK THAT NEEDS TO BE
DONE. THANK YOU. AND LET ME
TURN THINGS OVER TO THE DOCTORS
TO CONSIDER.
>> DR. DUE DA, I BELIEVE YOU'RE
THE PRIMARY REVIEWER.
>> THANK YOU SO MUCH DR. ELWOOD.
TO YOU AND YOUR TEAM. FOR
PREPARING THIS CONCEPT AND THIS
PRESENTATION. SO TO ME, THIS
CONCEPT IS PROPOSING THIS NEW
INVESTIGATION INTO CAUSAL
HYPOTHESES FOR HUMAN BEHAVIORS
THAT EFFECT OUR DOC HEALTH
OUTCOMES AND EVERYTHING BEYOND.
BECAUSE WE KNOW THAT ORAL HEALTH
HAS WHOLE BODY EFFECTS. SO TO
DATE NIDCR HAS A REALLY STRONG
BEHAVIORAL SCIENCE PORTFOLIO.
BECAUSE WE KNOW SO MANY ASPECTS
OF DOC HEALTH ARE LINKED TO OUR
BEHAVIORS. AND WE CAN BEST
ADDRESS THOSE BEHAVIORS WHEN WE
UNDERSTAND THEM. SO THE
DIRECTION OF THIS CONCEPT TO ME
IS CLEARLY ALIGNED WITH MANY
ASPECTS OF THE NIDCR STRATEGIC
PLAN AS WE JUST HEARD. THOSE
ASPECTS EMPHASIZE RESEARCH ON
BEHAVIORS AS A WAY TO INFORM
CLINICAL DECISION-MAKING FOR
BOTH PATIENTS AND HEALTH CARE
PROFESSIONALS. AS A WAY TO
DESIGN ORGANIZATIONAL STRUCTURES
THAT CAN OPTIMIZE CARE PATHWAYS.
TO HELP US BETTER UNDERSTAND
DENTAL, ORAL AND CRANIOFACIAL
PAIN AND OF COURSE TO BETTER
INFORM COST-EFFECTIVE
INTERVENTIONS. I ALSO THINK
THAT IN THIS CONCEPT THE FOCUS
ON BEHAVIORS AND THEIR ORAL
SYSTEMIC OUTCOMES ALIGNS WITH
THAT IDEA OF ORAL HEALTH BEING
AN ESSENTIAL COMPONENT OF WHOLE
BODY HEALTH WHICH WE AFFIRMED AT
THIS MEETING LAST YEAR. I AM
ALSO REALLY POSITIVE AND
INTERESTED IN THIS TRAJECTORY TO
LOOK AT ORAL HEALTH IMPROVEMENTS
FOR OUR MILITARY PREPAREDNESS
THAT SEEMS HIGHLY RELEVANT AND
LIKELY TO HAVE A HIGH IMPACT SO
OF COURSE THE CHALLENGE WITH
THIS NEW STRATEGY FOR CONCEPT IS
THAT A CONCEPT THIS BROAD,
RIGHT? IT'S HARD TO ENVISION A
SPECIFIC NOFO THAT MAY COME OUT
OF IT. AND SO I UNDERSTAND
WE'RE LOOKING AT THE PICTURE AS
A WHOLE. THIS MAY BE MULTIPLE
FUNDING ANNOUNCEMENTS. IT MAY
BE IN PARTNERSHIP WITH DIFFERENT
OTHER FUNDING AGENCIES. SO I
STRONGLY ENCOURAGE NIDCR TO
ENVISION AND MAKE CLEAR THE
INDIVIDUAL NOFOS THAT WILL COME
OUT OF THIS. OTHER THAN THAT I
FEEL THE CONCEPT ADDRESSES AN
IMPORTANT AND IMPACTFUL AREA AND
I AM PLEASED TO SUPPORT IT.
THANK YOU.
>> THANK YOU.
>> SORRY.
>> OKAY. SORRY, I WAS JUST
GOING TO ASK DR. DICKINSON TO
PROVIDE HIS COMMENTS.
DR. DICKINSON?
>> SORRY I KEEP FORGETTING THAT.
BUT THANK YOU, DR. ELWOOD FOR A
GREAT PRESENTATION ON SOMETHING
THAT IS CRITICALLY IMPORTANT.
BEING IN THE CLINIC AT BCU IN
THE DENTAL CLINIC AND SEEING
INTERACTIONS BETWEEN PATIENTS
AND STUDENTS THAT ARE TREATING
THEM SO OFTEN I SEE A LACK OF
SKILLS IN BEHAVIOR MANAGEMENT
NOT ONLY ON THE PATIENT BUT IN
UNDERSTANDING THAT IT'S MUCH
MORE THAN PUTTING A HOLE IN A
TOOTH. THAT THEY'RE THERE FOR.
AND HAVING MORE RESEARCH IN THIS
AREA I THINK IS EXCEPTIONALLY
GOOD TO NOT ONLY FOR THE
STUDENTS THEMSELVES BUT THE
PATIENTS THAT ARE COMING THERE
FOR CARE. SO I CERTAINLY WOULD
SUPPORT THIS AND HOPE THAT
EVERYBODY WOULD AGREE WITH THAT.
THANK YOU.
>> THANK YOU. ARE THERE ANY
COMMENTS OR QUESTIONS FROM OTHER
COUNCILMEMBERS BEFORE WE VOTE ON
THIS CONCEPT? DR. SLEP? YOU
HAVE YOUR HAND UP?
>> THANK YOU, I'M LIKE WAIT,
WHERE'S THE THING THAT ACTUALLY
RAISE MY HAND IN THE YELLOW
EMOJI RATHER THAN MY HAND I KNOW
SOMEONE HAD MENTIONED THAT THERE
WERE REVISIONS IS THE VERSION
THAT'S POSTED IN THE ELECTRONIC
COUNCIL BOOK IN THE FINAL OR
JUST CURIOUS.
>> YEAH. THAT IS THE SAME
PRESENTATION AT DR. ELWOOD.
>> PERFECT. OKAY. GREAT. I
JUST WANTED TO MAKE SURE I WAS
TRACKING EVERYTHING. NO OTHER
QUESTIONS.
>> GREAT. THANK YOU. SO WE'RE
GOING TO VOTE ON THIS CONCEPT
WOULD A MEMBER OF COUNCIL LIKE
TO MAKE A MOTION TO APPROVE THIS
CONCEPT?
>> I MOTION TO APPROVE THIS
CONCEPT.
>> THANK YOU.
>> I SECOND THAT.
>> GREAT. AND ALL IN FAVOR?
OKAY. ANY OPPOSED? OKAY.
HEARING NONE, THANK YOU VERY
MUCH. THIS MARKS THE END OF THE
CONCEPT CLEARANCES AND THE FINAL
ITEM ON THE AGENDA IS THE
NIDCR'S TRIENNIAL CLINICAL
RESEARCH REPORT ON TRACKING OF
WOMEN AND MINORITIES IN CLINICAL
RESEARCH. THIS REPORT HAS
ALREADY BEEN ACCEPTED
ELECTRONICALLY IN FEBRUARY THIS
YEAR BUT WE ARE REQUIRED TO
PRESENT IT AT THE OPEN SESSION
OF COUNCIL. DR. DINA FISHER
WILL PRESENT A VERY SHORT
SUMMARY OF THE REPORT. THANK
YOU.
>> GREAT. THANKS VERY MUCH,
EVERYONE, I THINK HALF OF MY
BRIEF PRESENTATION THE DOCTOR
JUST MENTIONED BUT I WILL OFFER
A SUMMARY OF THE 2025 TRIENNIAL
ADVISORY COUNCIL REPORT ON
COMPLIANCE WITH NIH'S CLINICAL
RESEARCH GUIDELINES. SO THE
COLLEGE RESEARCH GUIDELINES
WHICH REQUIRE THAT STUDY
PARTICIPANTS IN NIH SUPPORTED
CLINICAL RESEARCH ARE THE
REPORTING OF STUDY PARTICIPATION
BY SEX, ETHNICITY, RACE, AND AGE
ARE BOUND BY THESE TWO LAWS.
AND THAT'S HOW THESE GUIDELINES
CAME ABOUT. THE DOCTOR ALREADY
MENTIONED THE REPORTING THAT
THIS HAS ALREADY BEEN -- THE
REPORT HAS BEEN ACCEPTED BY
COUNCIL. THIS IS A TRIENNIAL
REPORT THAT'S REPORTING ON
FISCAL YEAR 2022-24 AND I'M
GOING TO PROVIDE A BRIEF
OVERVIEW OF THE DATA AND THIS IS
REPORTED BY AWARD RECIPIENTS IN
ANNUAL AND FINAL PROGRESS
REPORT. DURING THE FISCAL YEARS
OF INTEREST. SO IN GENERAL THE
NUMBER OF STUDIES THAT HAVE
CONTRIBUTED TO DATA HAVE
INCREASED. AND FOCUSING ON
ENROLLMENT BY SEX FIRST FEMALE
ENROLLMENT HAS BEEN MORE FEMALES
THAN MALES HAVE BEEN ENROLLED IN
CLINICAL RESEARCH STUDIES THAT
HAVE BEEN SUPPORTED BY NIDCR AND
REGARDING ETHNICITY, HIS TANNIC
OR LATINO HAS BEEN CONSTANTLY
THE SAME. MOVING ONTO RACE. IN
GENERAL MORE WHITE PARTICIPANTS
ARE IDENTIFYING AS WHITE HAVE
PARTICIPATED IN NIDCR SUPPORTED
CLINICAL RESEARCH. THERE HAS
BEEN AN INCREASE IN THE
REPORTING PERIOD IN BLACK OR
AFRICAN AMERICAN STUDY
PARTICIPATION AND FOR OTHER
RACES, THE PROPORTION OF
PARTICIPANTS HAS BEEN RELATIVELY
CONSISTENT. THE NEXT THREE
SLIDES I WILL JUST HIGHLIGHT
NIDCR SUPPORTED PHASE THREE
CLINICAL TRIALS. AND THE NUMBER
OF TRIALS THAT NIDCR HAS
SUPPORTED OVER THE REPORTING
YEARS OF FY 22-24 HAS BEEN 7-11
TRIALS. FEMALE ENROLLMENT
SIMILAR HAS BEEN CONSISTENT AND
MORE FEMALES HAVE ENROLLED IN
TRIAL, PHASE THREE TRIALS THAN
MALES HAVE. HISPANIC OR LATINO
ETHNICITY A LITTLE BIT OF AN
INTERESTING STORY BECAUSE THIS,
THOSE IDENTIFYING AS HISPANIC OR
LATINO IS A SUBSTANTIAL
PROPORTION OF STUDY PARTICIPANTS
AND HAS INCREASED OVER THE
REPORTING PERIOD. THOSE, FOR
RACE, WHITE AND BLACK OR AFRICAN
AMERICAN STUDY PARTICIPATION HAS
BEEN RELATIVELY SIMILAR FROM
THOSE TWO RACIAL CATEGORIES.
AND I JUST WILL MAKE A NOTE THAT
UNKNOWN OR NOT REPORTED RACE IS
SIGNIFICANT AND HAS INCREASED
OVER THE REPORTING PERIOD. BUT
JUST TO SUMMARIZE, THIS BRIEF
PRESENTATION, THERE'S A GENERAL
TREND OF INCREASED STUDY
PARTICIPATION ENROLLMENT WITH AN
INCREASE IN MINORITY ENROLLMENT
OVERALL IN FY24 MORE FEMALES
THAN MALES HAVE BEEN ENROLLED IN
CLINICAL RESEARCH STUDY
SUPPORTED BY NIDCR. THE RACIAL
AND ETHNIC DISTRIBUTION OF STUDY
PARTICIPANTS HAS REMAINED
RELATIVELY CONSISTENT OVER THIS
REPORTING TIMEFRAME. AND FOR
PHASE THREE TRIALS AS I HAD
BRIEFLY MENTIONED, THERE IS THIS
INCREASING TREND. THIS IS
PRIMARILY DUE TO THREE CLINICAL
TRIALS THAT FOCUSED ON HISPANIC
AND LATINO REPORTING ENROLLMENT
AND MANY OF THOSE INDIVIDUALS
REPORTED UNKNOWN OR NOT REPORTED
RACIAL CATEGORIES. AND FINALLY,
JUST TO OFFER AN OVERVIEW OF THE
TYPES OF PHASE THREE TRIALS THAT
NIDCR HAS SUPPORTED, THESE HAVE
BEEN FOCUSED ON CARR CARIES
PREVENTION OR TREATMENT.
REDUCTION OF DENTAL ANXIETY AND
TOBACCO CESSATION. RR CARIES
PREVENTION OR TREATMENT.
REDUCTION OF DENTAL ANXIETY AND
TOBACCO CESSATION. CARIES
PREVENTION OR TREATMENT.
REDUCTION OF DENTAL ANXIETY AND
TOBACCO CESSATION. CARIES
PREVENTION OR TREATMENT.
REDUCTION OF DENTAL ANXIETY AND
TOBACCO CESSATION. AND THAT'S
ALL.
>> THANK YOU VERY MUCH
DR. FISHER. OKAY. SO BEFORE WE
CLOSE THE MEETING I WOULD LIKE
TO ASK DR. JENNIFER WEBSTER FOR
SOME CLOSING COMMENTS ON THE
OPEN SESSION AND OTHER ITEMS
THAT SHE WOULD LIKE TO SHARE
WITH YOU, THANK YOU.
>> WELL FIRST LET ME THANK YOU
FOR JOINING US FOR THIS OPEN
SESSION. THERE WAS A LOT OF
OPPORTUNITIES TO SHARE AND TO
SHARE SOME SCIENCE. LET ME TAKE
THIS OPPORTUNITY TO THANK OUR
RETIRING MEMBERS THERE COUNCIL,
DR. JACQUES NOR AND DR. AMY
SLEP. THANK YOU FOR YOUR
COMMITMENT. THANK YOU FOR YOUR
EXPERTISE AND THANK YOU FOR YOUR
UNWAVERING SERVICE TO NIDCR.
KNOW THAT YOU ARE APPRECIATED.
AND I WILL NOW CLOSE OUR 239TH
COUNCIL. THANK YOU.
>> THANK YOU.