>>WELCOME TO NIDCR COUNCIL
EMAIL WE WILL DISPLAY AT THE END
OF THE SESSION.
WE ASK THAT COUNCILMEMBERS AND
STAFF PLEASE MAKE SURE YOUR
MICROPHONES ARE SET TO MUTE
UNLESS WHEN YOU'RE SPEAKING.
PLEASE IDENTIFY YOURSELF SO WE
KNOW WHO'S SPEAKING AND TO
ENSURE THE ACCURACY OF OUR
COUNCIL RECORDS
IF ANYONE PARTICIPATING NEEDS
HELP WITH TECHNICAL PROBLEMS MR. TIM --
[ INAUDIBLE ] FROM OUR IT
SUPPORT WILL BE AVAILABLE TO
ASSIST YOU AND THEIR CONTACT
INFORMATION IS IN THE CHAT BOX
AND NOW I'M GOING TO TURN IT
OVER TO DR. RENA DESOUZA.
>> THANK YOU, LYNN AND GOOD
MORNING, EVERYONE.
WITH MANY GREETINGS FROM NIDCD
AND ITS STAFF AND LEADERSHIP AND
THE COMMUNITY AT NIH.
WE HAVE VERY MUCH HELD YOU IN
OUR HEARTS ALL OF THESE MONTHS.
NOW SOMEONE HAS THEIR MIC ON OR
SOMETHING.
SO PLEASE BE CAREFUL.
WHAT I HOPE TO DO IN THIS
COUNCIL SESSION IS TO GIVE YOU
AN OVERVIEW OF WHERE WE ARE
TODAY.
HOW WE IN AN UNSETTLED TIME HAVE
STAYED TRUE TO OUR MISSION USING
THE LESSONS LEARNED FROM THE
PANDEMIC TO KEEP MOVING FORWARD
SO THAT WOULD BE THE FIRST
INTENT.
OBVIOUSLY WE HAVE MANY WISHES OF
FAREWELL AND GRATITUDE TO OUR
LEADERS WHO HAVE SERVED US WELL
AND HAVE LEFT THE INSTITUTE OR
IN TRANSITION AND TO WELCOME
NEWCOMERS.
SO HERE FIRST OF ALL IS
DR. FRANCIS COLLINS.
I'M SO GRATEFUL THAT HE HIRED ME
AND I HAD THIS YEAR PLUS OF
WORKING WITH HIM.
HE WAS PATIENT AND UNDERSTANDING
AND LISTENING TO ORAL HEALTH
ISSUES AND WAS ABSOLUTELY A
LEGACY OF A LEADER FOR OUR
INSTITUTION AND THE COUNTRY AND
THE WORLD.
I ENCOURAGE YOU TO WATCH HIS
FAREWELL TRIBUTE WHICH IS A
ONE-OF-A-KIND STAR-STUDDED
TRIBUTE.
NOT BECAUSE THE DIRECTORS HAD A
CHANCE TO SAY SOMETHING BUT ALL
OF THE LIVES AND PEOPLE THAT
FRANCIS HAD TOUCHED.
A LOT OF GOOD WISHES COME HIS
WAY AND I KNOW HE WILL CONTINUE
TO STAY IN TOUCH WITH HIS
RESEARCH AND WOULD BE A
WONDERFUL COLLEAGUE FOR ME TO
SHARE COFFEE WITH.
THIS IS AN UNPRECEDENTED TIME.
THAT IS UNDER STATING THE FACT
THAT LARR -- LARRY TABAK * DEALING
WITH THE RETURN TO WORK ISSUES.
I HAVE TO PINCH MYSELF -- TO
BELIEVE THAT WE HAVE SOMEONE
FROM OUR OWN COMMUNITY IN THE
HIGHEST POSITION.
CONGRATULATIONS.
WE KNOW THAT YOU WILL BE THE
PERSON THAT IS KEEPING US AFLOAT
AND STEADY.
VERY SPECIAL THANK YOU TO ALICIA
DEMBROSKY.
ALICIA HAS CHOSEN TO RETIRE.
LEAVING BEHIND A VERY, VERY
SOLID OFFICE OF DEVOTED STAFF
AND WELL ESTABLISHED PRACTICES.
AS YOU CAN SEE HERE ALICIA HAD
ORGANIZED 39 COUNCILS AND 23BS
23BSC's.
CONGRATULATIONS.
WE HAD A FAREWELL ACKNOWLEDGMENT
OF ALICIA AND I HOPE YOU WILL
CONTINUE TO SEND HER MESSAGES.
VERY HAPPY TO WELCOME LYNN KING
ON-BOARD.
LYNN IS A VERY FAMILIAR FACE TO
OUR COMMUNITY.
HAVING REALLY CHAMPIONED
TRAINING AND CAREER DEVELOPMENT.
SHE BRINGS A WEALTH OF
EXPERIENCES AND AS YOU CAN SEE
THROUGHOUT AND IN ALL OF THE
PORTFOLIOS INVOLVED IN THE
DIVISION OF EXTRAMURAL
ACTIVITIES.
VERY EXCITED TO HAVE YOU
ON-BOARD.
TRULY A THRILL TO INTRODUCE
JENNIFER WEBSTER-CYRIAQUE.
WHO CAME FROM THE UNIVERSITY OF
NORTH CAROLINA WHERE SHE SPENT
MANY YEARS DEVELOPING HER
CAREER.
SHE IS KNOWN TO SO MANY AROUND
THE COUNTRY AS NEUROLOGIST AND
HOSPITAL DENTISTRY EXPERTISE AND
I VERY TRUE PASSION FOR HEALTH
DISPARITY RESEARCH.
SHE WILL HAVE -- WILL BE AT MY
RIGHT HAND -- SHE WILL ALSO HAVE
A LAB IN NIAD BUT HOUSED IN
NIDCD SPACE BUT UNDER JEFF COLIN
ACE LEADERSHIP AT NIAD AND WILL
FOCUS ON VIRAL ESPECIALLY DEE -- EPIDEMIOL OGY.
VERY HAPPY TO HAVE YOU ON-BOARD
JENNIFER AND I KNOW YOU WILL BE
IN TOUCH WITH SEVERAL OF THOSE
LISTENING TO US TODAY.
ALSO VERY HAPPY TO INTRODUCE
RENEE JOSKOW.
*.
ALSO ASKING IN THE OFFICE OF
SCIENCE POLICY AND ANALYSIS AS
ITS DIRECTOR.
RENEE HAS EVERY CONTACT IN PLACE
THAT SHE HAS DEVELOPED
STEADFASTLY OVER THE YEARS.
SHE BRINGS A WEALTH OF EXPERTISE
IN MANY AREAS AND AS YOU CAN SEE
HERE SHE WILL BE OUR AMBASSADOR
OUR SPOKESPERSON FOR THE ORAL
HEALTH IN AMERICA REPORT TAKING
ITS MESSAGE TO VARIOUS
CONSTITUENTS ACROSS THE COUNTRY
WITH THE PURPOSE OF SHARED
OWNERSHIP AND EVERYONE LOOKING
TO WORK TOGETHER TO ACTUALLY
MOVE THE NEEDLE ON HEALTH
DISPARITIES AND/ORAL DISEASES
AND CONDITIONS.
SHE WILL ALSO BE WATCHING OVER
AND ACTUALLY DIRECTING THE
DENTAL PUBLIC HEALTH FELLOWSHIP
TRAINING PROGRAM.
AND SHE AS YOU CAN SEE HERE WILL
BE INSTRUMENTAL IN SHAPING THE
VISION AND CREATING A NOVEL
PRESENCE FOR NIDCD IN CONNECTING
WITH OTHER FEDERAL AGENCIES
WHOSE COLLABORATION WE NEED FOR
THIS MULTI-DISCIPLINARY APPROACH
TO MORE WHOLISTIC TREATMENT.
HAPPY TO WELCOME JACQUES NOR.
YOU ARE THE CURRENT PRESIDENT OF
AADOCR.
A STRONG ALLEY AND STAKEHOLDER.
WELCOME ON-BOARD.
LOOK FORWARD TO WORKING WITH YOU
AND AMY SLEP.
WHO BRINGS REALLY DISTINGUISHED
TRACK RECORD AND A VERY UNIQUE
AND SPECIALIZED EXPERTISE IN THE
AREA OF FAMILY ENVIRONMENT.
THANK YOU FOR AGREEING TO SERVE
AND WE'RE DELIGHTED TO HAVE YOU.
AND WHAT BRING TO THE TABLE
RIGHT NOW IS AN AREA THAT NIDCD
WISHES TO FOCUS ON.
NOW I WANT TO TURN THIS BACK TO
LYNN WHO WILL BE PRESENTING THE
MINUTES FROM OUR LAST COUNCIL.
LYNN.
>> THE FIRST ITEM OF BUSINESS IS
THE APPROVAL OF THE MINUTES FROM
THE PREVIOUS MEETING.
FROM SEPTEMBER 2021 COUNCIL
MEETING.
AND WERE MADE AVAILABLE TO
COUNCILMEMBERS FOR THEIR REVIEW.
ARE THERE ANY COMMENTS OR
CORRECTIONS TO THE
SEPTEMBER 2021 MEETING?
MEETING MINUTES?
IF NOT WOULD A MEMBER OF COUNCIL
LIKE TO MAKE A MOTION OF
APPROVAL OF THE MINUTES?
>> I MAKE A MOTION TO APPROVE.
>> A SECOND.
>> SECOND.
>> ALL APPROVED.
AYE.
>> AYE.
>> AND ANY OPPOSED?
OKAY.
THANK YOU VERY MUCH.
NOW WE'RE GOING TO DO THE ANNUAL
REVIEW OF COUNCIL OPERATING
PROCEDURES.
EVERY YEAR AT THE JANUARY
MEETING COUNCIL REVIEWERS REVIEW
AND APPROVES THE ADVISORY
COUNCIL OPERATING PROCEDURES AND
MAKES RECOMMENDATIONS FOR
REVISION WHERE APPROPRIATE.
NADCRC IS NOT RECOMMENDING ANY
CHANGES THIS YEAR.
DOES ANYONE FROM COUNCIL HAVE
SUGGESTIONS FOR CHANGES, HAVE
COMMENTS OR ANY QUESTIONS?
OKAY.
WOULD A MEMBER OF COUNCIL LIKE
TO MAKE A MOTION TO APPROVE THE
COUNCIL OPERATING PROCEDURES?
>> I'LL MAKE THAT MOTION.
>> I WOULD SECOND.
>> THANK YOU.
ALL IN FAVOR.
>> AYE.
>> AND ANY OPPOSED?
OKAY.
GREAT.
NOW WE'LL TURN IT OVER TO THE
NADCRC DIRECTOR'S REPORT.
>> THANK YOU, LYNN.
AND AS YOU CAN SEE I LOVE THIS
PICTURE BECAUSE IT SHOWS THE
WAVE OF THE PANDEMIC IS STILL
UPON US BUT WE LOOK TO THE
FUTURE WITH MUCH HOPE AND
PROGRAM.
SO I WOULD LIKE TO -- IT'S A
VERY DENSE PRESENTATION TO LET
YOU KNOW AND REMIND YOU THAT IT
WILL BE RECORDED AND I WILL BE
HAPPY TO SHARE THE POWER POINT.
TO GIVE YOU A BRIEF OVERVIEW OF
THE NEW -- OF NEWS FROM NIH'S
EFFORTS IN THE PANDEMIC AND HOW
THESE INITIATIVES ARE HERE TO
STAY PERHAPS AND COULD EASILY BE
TRANSLATED TO WHAT WE DO.
WE HAVE A DISTINGUISHED PANEL OF
GUESTS AND I'M DELIGHTED THAT
DR. -- WHO IS DIRECTOR OF THE
NATIONAL INSTITUTES OF MINORITY
HEALTH AND HEALTH DISPARITIES IS
HERE AND HE WILL ILLUSTRATE ONE
EXAMPLE ON CAMPUS THAT HAS A
TREMENDOUS RAMIFICATION FOR THE
FUTURE.
I'LL GIVE YOU A BRIEF OVERVIEW
OF THE BUDGET.
IT'S IN CONTINUING RESOLUTION
RIGHT NOW AND WE'RE HOPING IT
DOES GET APPROVED BUT I'LL GIVE
YOU AN IDEA AS TO WHERE WE ARE.
IT WAS A YEAR THAT WAS.
AND 21 WAS A YEAR THAT WAS
BECAUSE WE ACCOMPLISHED TWO
MAJOR MILESTONES THAT I WILL
TOUCH O ON.
THE REPORT ITSELF AND OUR
STRATEGIC PLAN.
I WANT TO SPECIFICALLY FOCUS ON
HOW NIDCD IS POSITIONING TO
REDUCE PUBLIC HEALTH BURDENS AT
A PLACE THAT IS
DISPROPORTIONATELY ON THIS
SEGMENT OF THE POPULATION.
SO, IT'S NOT JUST THE FACT THAT
THERE ARE DISPARITIES.
IT'S THE FACT THAT DESPITE THE
SCIENCE AND TECHNOLOGY ADVANCES
DESPITE THE WONDERFUL BRILLIANCE
OF THE SCIENCE IT HAS NOT BEEN
ENOUGH TO ACTUALLY MOVE THE
NEEDLE IN A SIGNIFICANT WAY FOR
MANY IN THIS COUNTRY.
SO I'M GOING TO CHAT ABOUT THAT
AND HOW OUR STRATEGIC PLAN
ADDRESSES THAT SPECIFICALLY.
VERY MUCH AT THE CENTER OF OUR
ACTIVITIES ON CAMPUS AND WITHIN
THE INSTITUTE IS HOW DO WE SHAPE
OUR BIOMEDICAL WORKFORCE.
CREATE ONE THAT REPRESENTS THE
DEMOGRAPHICS OF OUR NATION AND
ADDRESS THE PUBLIC HEALTH
BURDENS OF DISEASE.
NEW AND EXCITING SUGGESTIONS FOR
HOW COUNCIL WILL ENGAGED FOR THE
FUTURE AND PERHAPS A FAR MORE
ACTIVE WAY OF THAN IN THE PAST
BUT NOT IN MY WAY UNUSUAL
BECAUSE MANY OF THE COUNCILS
WORK SIMILARLY WHICH IS TO
CREATE THE WORKING GROUPS AND
THE CONVERSATIONS THROUGHOUT THE
YEAR AND IN BETWEEN COUNCIL
MEETINGS.
AND THEN FINALLY TO INTRODUCE
OUR GUEST.
WE HAVE A LOT TO COVER.
SO THIS IS WHERE WE ARE WITH THE
RETURN TO WORK.
AND THE FUTURE WORKPLACE
DISCUSSION.
NOTHING THAT IS SURPRISING TO
YOU.
NIH WILL MAINTAIN A VERY
FLEXIBLE WORKPLACE.
IT WILL LIKELY TAKE ON HYBRID
MODES.
AND OF COURSE AS YOU MUST KNOW
TRAVEL AND CAMPUS WIDE MEETINGS
RIGHT NOW DECISIONS ARE STILL
PENDING ON THE STATUS OF THOSE
EVENTS BECAUSE OF OMICRON
ESSENTIALLY.
BUT WHAT I WANT TO SAY IS THAT
THE HYBRID STATE THAT WE'RE IN
HAS OPENED UP TREMENDOUS DOORS
FOR COMMUNICATION THAT COULD BE
VIRTUAL AND THAT HAS ITS
ADVANTAGES SOMETIMES OVER IN
PERSON TRAVEL AND THERE ARE
ADVANTAGES AND DISADVANTAGES ON
BOTH ENDS BUT HAVING THE HYBRID
MODE ALLOWS US TO CAPITALIZE AND
IMPROVE ON HOW WE STAY CONNECTED
THROUGHOUT THE YEAR.
SO I THINK THAT FOR ME IS A
WONDERFUL TAKE HOME MESSAGE
ABOUT THE PANDEMIC.
NOW THIS IS THE LATEST WE HAVE.
THERE IS A LOT OF WORK BEING
DONE ON THE IMMUNOLOGY OF THE
VIRUS ITSELF AND THE VARIANTS.
THE LAST BULLET INDICATES THAT
THERE IS NEW DATA SHOWING THAT
DURING PREGNANCY IT IS POSSIBLE
FOR THE FETUS TO ACTUALLY
RECEIVE OR REACT WITH
INFLAMMATORY IMMUNE RESPONSES
AND THAT IS BEING STUDIED.
WE ALSO KNOW THAT ANTIBODY
LEVELS ARE NOT THE ONLY MEASURE
BECAUSE THERE IS THE CELLULAR
ASPECT OF TC AND B CELL MEMORY
RESPONSES THAT PLAY A ROLE IN
PROTECTING US.
NOW THE ACTIVE ARM OF NIH'S
RESPONSE TO COVID INVOLVED MANY,
MANY INITIATIVES.
ACTIVE ITSELF IS VERY DEDICATED
TO LOOKING AT THE THERAPEUTIC
ASPECTS.
REPURPOSED DRUGS.
MONO CLONES.
SINGLY OR IN UNIFORM.
WE CAN VERY QUICKLY DETERMINE
THE LEVEL OF PATHO GET NEWS TEE
* OR INFECT IVITY.
WHAT IS INTERESTING IN PREPARING
FOR THE NEXT PANDEMIC WE HAVE
NIH RESEARCHERS THAT ARE
ESTABLISHING THE PLATFORMS THAT
WILL QUICKLY OR FAST-TRACK DATA
ON NEW VARIANTS THAT THE
INFRASTRUCTURE FOR ACTUALLY
MONITORING AND TESTING THESE
VARIANTS, I DO BELIEVE THAT
MODENA IS IN THE PROCESS OF
PREPARING OMICRON SPECIFIC VIRUS
VACCINE BECAUSE IT IS IN FACT A
PECULIAR STRAIN AND PREPARE US
TO BE AS BEST PROTECTED AS WE
CAN.
AND TO FORCE DISSEMINATE RAPIDLY
AND WIDELY THROUGH THE
COMMUNITY.
NOW DR. -- WILL BE TALKING ABOUT
WHAT I CONSIDER A VERY IMPORTANT
PROGRAM THAT GREW FROM OUR
AWARENESS FOR THE THINGS THAT
NIH HAD DONE WELL.
THAT OUR NATION HAD DONE WELL
AND ALSO REALIZING AND EMBRACING
THE NEED FOR CHANGE AND FOR
MAKING THINGS BETTER FOR THE
FUTURE.
THE COMMUNITY ENGAGEMENT AND
LEADERSHIP AND CREATING A
DIVERSE GROUP OF -- A NETWORK OF
OF CONTACTS WITH VARYING
COMMUNITIES AROUND OUR COUNTRY
IS ABSOLUTELY NECESSARY.
AND SO AS YOU CAN SEE ON THE
RIGHT THE OUTREACH WAS TO ALL OF
OUR COMMUNITY LEADERS IN EVERY
SEGMENT OF OUR POPULATION.
THIS STUDY WHICH IS THE HUB IS
BASED AT NYU LOOKING AT
LONG-STANDING CONSEQUENCES OF
COVID INFECTION OR SARS COVID 2
INFECTION AND THAT IS VERY MUCH
IN THE TRACK RIGHT NOW.
KEEPING A STRONG TRACK ON.
WE'VE HAD FOR NIDCD A ROBUST
FORROW --ROBUST PORTFOLIO.
AND YOU CAN SEE THAT HERE.
I'M PLEASED TO SAY THAT THE PBRN
HAS A RESEARCH REGISTRY CALLED
CORE THAT IS AVAILABLE RIGHT NOW
AND ACTIVE AND THAT WE'RE
LOOKING AT CONDITIONS IN
PRODUCTION OF AEROSOLS AND MANY
OTHER CONSEQUENCES OF HOW WE
PRACTICE OUR DENTISTRY AND
DELIVER CARE TO POPULATIONS AT
LARGE.
THERE ARE MANY DENTIST THAT ARE
ACTUALLY ENGAGED IN DELIVERING
VACCINES AROUND THE COUNTRY.
LIKE THE UNIVERSITY OF PACIFIC
THAT HAVE PLAYED A VERY STRONG
ROLE IN HELPING THE COMMUNITY.
SO VERY PLEASED TO HEAR THAT.
SO I'VE BEEN AROUND VIRTUALLY OF
COURSE AND BEEN AS FAR AS I
COULD REACHING OUT TO OUR
STAKEHOLDER ORGANIZATIONS
KEEPING EVERYONE ABREAST OF THE
PROGRESS WE MADE WITH THE
PREPARATION TO REPORT WHICH IS
VERY EAGERLY AWAITED AND
CONNECTING WITH GIVING YOU AS
FAR AS POSSIBLE IN THE MOST OPEN
AND TRANSPARENT MANNER -- OF
WHERE WE WERE GOING WITH OUR
MISSION AND WHERE OUR CURRENT
CONCEPTS ARE HEADING.
SO IS THAT A GROUP OF TALKS
INCLUDING SOME VERY SPECIAL NIH
WIDE CONNECTIONS THAT ARE
EXTREMELY VALUABLE TO OUR
MISSION.
I'LL CONTINUE TO DO THAT OVER
THE YEAR.
I THINK IT WILL BE A HYBRID YEAR
AND ALSO VIRTUAL TALKS.
OUR BUDGET TODAY IS IN
CONTINUING RESOLUTION.
SO EVERYTHING IS ESTIMATED.
YOU CAN SEE WE'VE STAYED VERY,
VERY DIRECTED TO MEETING ALL OF
THE ARMS OF OUR MISSION.
AND YOU CAN SEE THAT DIVIDED
INTO CATEGORIES AND BETTER
REPRESENTED HERE IN THE PIE
CHART.
WE HAVE A HEALTHY BALANCE OF 78%
OF OUR EXTRAMURAL BUDGET OF
$377 MILLION GOING TOWARDS
RESEARCH PROJECT GRANTS.
AND NONCOMPETING RBGs STILL
REMAIN DOMINANT WITH 19% NEW
RPGs BEING FUNDED.
IF YOU PUT IT IN THE CONTEXT OF
WHAT YOU WILL SOON LEARN WE
PERHAPS WILL BENEFIT GREATLY
FROM INVESTING MORE HEAVILY IN
CAREER AND TRAINING DEVELOPMENT
AND I HOPE IN THE NEXT FEW YEARS
THIS WILL BE REFLECTED IN THE
PIE CHART.
COMPARED TO THE PURCHASING POWER
NIH IS ALSO SUBJECT TO TIN -- SUBJECT TO
INFLATION.
SO WE HAVE TO PAY ATTENTION TO
THAT.
AND YOU CAN SEE HERE IN 21 THAT
WE ARE KIND OF A LITTLE LOWER
THAN 20 BUT BETTER THAN PREVIOUS
YEARS.
OUR RPG RATE -- -- IT IS
APPROACHING 25% FOR 21.
NOW DENTAL SCHOOL FUNDING
REMAINS AT ABOUT 45%.
YOU CAN SEE IT'S NOT A NUMBER
THAT I HOPE WILL STAY STATIC.
WE INTEND TO VERY MUCH ENGAGE
AND INVEST FURTHER IN RESEARCH
THAT IS BASED ACADEMIC RESEARCH
THAT IS BASED IN DENTAL SCHOOLS
AND THERE IS A REASON FOR THAT.
IN DEFINING WHAT BEST SCIENCE IS
TODAY IS DIFFERENT THAN WHAT IT
WAS DEFINED IN PREVIOUS YEARS.
BECAUSE BEST SCIENCE TODAY
RELIES VERY MUCH ON CHAIR SIDE
OBSERVATIONS AND TRANSLATION TO
THE BENCH OR TO COMMUNITIES AND
FOR THAT REASON WE EMBRACE
DENTAL SCHOOLS WHO HAVE IN THE
PAST NOT HAD THE RESOURCES OR
EVEN THE SUPPORT NECESSARILY TO
DEVELOP RESEARCH INTENSE
MISSIONS AND IT DOESN'T HAVE TO
BE INTENSE.
IT CAN BE SUPPORTIVE.
WE HAVE MANY MECHANISMS IN PLACE
TO DRAW DENTAL SCHOOLS INTO THE
COMMUNITY OF ORAL BIOMEDICAL
RESEARCH FOLKS AND THE REASON
BEING IS THAT CHAIR SIDE
OBSERVATIONS -- AND WE DO CARE
ABOUT TRANSLATION.
IT'S HARD NOT TO WANT TO BRAG
ABOUT OUR INTRAMURAL PROGRAM SO
I ASKED FOR BRAD TO SUMMARIZE
THE HIGHLIGHTS.
THERE WERE ABOUT 100 PAPERS BUT
HE PICKED A FEW THAT ARE TRULY
PARADIGM SHIFTING.
REFLECTING THE WORK OF OUR
RESEARCHERS.
THEY GIVE OUR INSTITUTE MUCH
PROMINENCE ON CAMPUS AND THE
WORLD.
SO I WANT TO THANK THEM AND
APPRECIATE MATT'S LEADERSHIP IN
GUIDING THIS GROUP OF 27 VERY
TALENTED PRINCIPLE INVESTIGATORS
AND YOU CAN SEE THEM AS WE GO
THROUGH THE LIST THAT IT
COMPANIES HAVE A BROAD RANGE OF
TOPICS IN TOP CITED JOURNALS.
OKAY.
SO THE REPORT AND HOW DID IT
COME ABOUT?
NADCRC -- -- TOOK IT ON WITH A
GREAT SENSE OF COMMITMENT.
WE SHEPHERD THE REVIEW PROCESS
IN EDITING.
IT CAME FROM 400 CONTRACTORS WHO
WERE LED BY TALENTED AND
COMMITTED EDITORS.
WE EXAMINED THE PROGRESS MADE
SINCE 2000.
IT WAS ORGANIZED ACROSS THE
LIFE-SPAN LOOKING AT DISEASE
TRENDS AND WHERE WE ARE TODAY
AND WHAT PROGRESS WE'VE MADE AND
DELIVERING A VERY IMPORTANT SET
OF CAUSE FOR ACTION THAT I HOPE
THAT WE CAN ALL TAKE SERIOUSLY.
CALLS TO ACTION AND WORK ON SO
THAT WE CAN REALLY HELP MOVE THE
NEEDLE AND THE PLAN IS TO MAKE
IT A LIVING DOCUMENT.
ONE THAT WILL CONTINUE TO GUIDE
BOTH NIDCD AND ALL OF OUR
STAKEHOLDERS.
THIS IS THE SPACE TO ACKNOWLEDGE
THE CONTRIBUTIONS.
WE'RE HOPING TO DO SO WITH
INDIVIDUAL RECOGNITION.
AND AS YOU CAN IMAGINE A 750
PAGE REPORT COULD NOT HAVE BEEN
PUT TOGETHER IN THAT PERIOD OF
TIME DURING THE PANDEMIC.
AND WITH SO MANY CHANGES IN OUR
SYSTEM WITHOUT THE HELP OF THIS
COMMITTED GROUP SO I WANT TO
THANK JUDITH AND BRUCE FOR
KEEPING EVERYTHING ON COURSE.
BOB AND JOCELYN AND CATHERINE
AND CHRISTIAN AND LAURI FOR YOUR
LEADERSHIP IN DRIVING EACH OF
THOSE SIX SECTIONS.
THERE WAS A STAFF AS WELL AS
INDIVIDUALS WHO CAME FORTH AND
REALLY DEDICATED MANY HOURS OF
WORK TO GETTING THIS THROUGH.
THANK YOU AGAIN.
NOW WHAT DOES THE REPORT TALK
ABOUT?
IN THE LAST 20 YEARS WE HAVE TO
ADMIT THE DEMOGRAPHICS OF THIS
NATION HAVE CHANGED.
THAT WE MOVED INTO THIS
DIGITIZATION AGE NOT JUST IN OUR
PRACTICES BUT THE WAY THAT WE
DELIVER OUR CARE AND EVEN
ANALYZE OUR DATA.
SO AT THE DELIVERY OF OUR
SERVICES THAT HAVE CHANGED.
DENTISTRY AND TELEHEALTH AND
TELEMEDICINE CAN WORK.
BUT ALSO THINKING OF THE LARGE
DENTAL SERVICES ORGANIZATIONS
THAT HAVE MOVED THE NEED EL ON
THE MEASUREMENTS OF OUTCOMES.
OUAND THE RISING HPV CANCERS THAT
ARE THE MOST DOMINANT OF ALL HPV
CANCERS AND ALSO DOMINATING IN
THE FIELD OF HEAD AND NEXT
CARCINOMAS.
OUR DISCOVERIES HAVE BEEN
AMAZING AND WORTH NOTING BUT WE
CONTINUE TO EXIST -- THE DIVIDES
AND BARRIERS AND DETERMINANTS OF
HEALTH.
I WAS THINKING OF ALL OF THE
Ds.
SO WHEN I THOUGHT OF WHAT THE
CAUSE TO ACTION WOULD BE I
THOUGHT OF THIS LIST.
THAT WE NEED THAT RESEARCH
ENTERPRISE THAT WILL SIMPLY
CREATE THE EVIDENCE THAT HAD
WILL DRIVE REFORMS AND POLICY
CHANGES.
NADCRC CAN PROVIDE THE RESEARCH
THAT DRIVES THE EVIDENCE.
WE CLEARLY CAN BE INVOLVED
THROUGH OUR IMPLEMENTATION
SCIENCES AND STRATEGIES AND OUR
POPULATIONS TO HELP REDUCE THE
NEGATIVE IMPACT OF UPSTREAM
DETERMINANTS.
THE NEED TO FIGURE THE DELIVERY
AND CONFIGURE WHAT WORKS BEST
FOR WHICH POPULATION.
TO REIMAGINE DENTAL EDUCATION IN
THIS CHANGING UNIVERSE TO BE
MORE INTEGRATED AND MORE
AFFORDABLE.
AND THEN ALL OF THIS TOGETHER
WOULD HELP REDUCE OR ELIMINATE
THE SOCIO AND ECONOMIC.
THIS REQUIRES US COMING TOGETHER
WITH A PLAN.
SO HERE IS AN EXAMPLE OF THE
IMPACT THAT WE HOPE THE REPORT
WILL HAVE.
AS YOU CAN SEE IT WAS WELL
RECEIVED.
IT WAS QUITE ROBUST.
THE RESPONSE TO THE WEBINAR
ITSELF AND ALL THAT FOLLOWED AND
JDE's DEPARTMENT KEEPS -- THEY
WATCH THESE TRENDS AS THEY'VE
GROWN.
WE HAVE PUBLISHED TWO ARTICLES.
IT'S STAGGERED SO WE BRING
ATTENTION TO THE REPORT AT
DIFFERENT TIMES.
WE DECIDED THAT TARGETED
ARTICLES THAT WOULD BE OF
INTEREST TO FOCUS GROUPS WOULD
BE PUBLISHED IN THE JOURNAL OF
EDUCATION.
JADA AND OF COURSE THE JOURNAL
OF DENTAL RESEARCH AND CREATING
WITHIN US THIS SHARED OWNERSHIP.
THE SENSE OF SHARED OWNERSHIP.
THAT IS ESSENTIAL FOR
FOLLOW-UPS.
RIGHT.
RENEE AND JENNIFER AND MYSELF
AND OTHERS WILL OUTREACH TO
STAKEHOLDER GROUPS ACROSS THE
NATION.
AN EXAMPLE IS THE AADOCR WEBINAR
THAT WILL FOCUS SPECIFICALLY ON
THE RESEARCH OPPORTUNITIES THAT
THE REPORT SUGGEST AND THAT WILL
BE FOLLOWED BY OTHER WEBINAR AND
OTHER FORUMS FROM ADA AND DENTAL
PUBLIC HEALTH.
AND I WANT TO SAY THAT EVEN
THOUGH WE TALK ABOUT THE BURDENS
OF DISEASE THAT IT'S IMPORTANT
TO CELEBRATE THE RESEARCH
ADVANCES SO FAR.
THERE IS A LOT MORE TO BE DONE.
IT JUST GIVES US THAT REASON TO
EXIST.
SO I WANTED TO PUT UP THIS
MESSAGE BECAUSE IT ACTUALLY
SUMMARIZES THE HEART THAT BEATS
SO STRONGLY AS WE WORK TOWARDS
MEETING THE GOALS WE REPORT AND
IT'S VERY WELL STATED IN THIS
COVERLETTER.
WITH THE ENDORSEMENT OF THE
SURGEON GENERAL OF FRANCIS
COLLINS AT THAT TIME SO PLEASE
READ IT.
THE EXECUTIVE SUMMARY IS A NICE
ENCOUNTER OF WHAT IS IN THE
REPORT.
WE WERE GUIDED BY WHAT THE
REPORT WAS SUGGESTING BUT WE
DIDN'T HAVE THE REPORT READY AT
THE TIME WE BEGAN PLANNING FOR
OUR NEXT FIVE YEARS.
NOW THE PREVIOUS DIRECTOR AND
HER TEAM HAD INITIATED THE
PROCESS AND WE HAD RECEIVED
RESPONSES TO TH CALL.
WE ALMOST HAD TO LOOK AT OUR
FUTURE WITH A NEW SET OF LENSES
BECAUSE THE WORLD HAD IN FACT
CHANGED AND THERE WERE THREE
PRINCIPLES THAT I WANT YOU TO
THINK ABOUT.
AND ASSOCIATE WITHIN NIDCD AND
TAKE INTO YOUR OWN ECOSYSTEM.
THE NEED TO TRANSLATE ACROSS THE
SPECTRUMS MORE CRITICAL THAN
EVER.
THE FACT THAT WE CREATE A SENSE
OF EQUITABLE DIVERSE AND
INCLUSIVITY IN EVERYTHING THAT
WE DO AND TO FOCUS ON MEASURING
WHAT WE DO SUCH THAT WE CAN KNOW
WHAT THE RETURN OF INVESTMENT
IS.
WHAT WORKS AND WHAT DOESN'T
WORK.
AND BE ALWAYS GUIDED BY OUR CORE
VALUES WHICH WILL BE EMPHASIZED
AGAIN IN A FEW MINUTES.
I PUT THIS ON.
THESE ARE OUR STRATEGIC
PRIORITIES.
NOW NOTE HERE THAT IN THE CENTER
ON THE LEFT SCHEMATIC IS THE
PATIENT.
AVENUE THAT EVERY ONE OF OUR
RESEARCH EXPERT COUNTS.
ARE SOME FURTHER ALONG THAN
OTHERS.
IT'S THE NATURE OF THE WAY WE'VE
DEVELOPED.
BUT AS YOU CAN SEE IT'S ALL
IMPORTANT.
IT'S NOT ONE THAT YOU CAN COUNT
ON AS BEING THE DRIVING ONE BUT
THAT BASIC AND FOUNDATIONAL
RESEARCH AND SCIENCES WILL FEED
HYPOTHESIS THAT CAN BE TESTED
AND THAT OUR PUBLIC HEALTH
OBJECTIO--OBSERVATION IS VERY POSSIBLE
TODAY.
THE FIRST GOAL AND I'LL SAY THIS
EVEN THOUGH WE DESCRIBED IT A
COUPLE OF COUNCIL AGO IS TO ADD
THE MEAT TO THE BONES OF
UNDERSTANDING THE DISEASE
PROCESSES THAT WE ARE CONCERNED
ABOUT.
AND IF WE DON'T KNOW THE
PATHOGENESIS COMPLETELY THAT THE
DEEP PHENOTYPING ASSOCIATED WITH
THESE DISEASES WE CANNOT MAKE
THOSE CONNECTIONS TO SYSTEMATIC
DISEASES SO WE NEED TO DO BOTH
AT THE SAME TIME AND WE DO KNOW
THERE IS AN ASSOCIATION.
THERE IS IS NOT DOUBT ABOUT
THAT.
PUTTING THE CELLULAR AND
MOLECULAR DETERMINANTS ON THAT
HYPOTHESIS TO GIVE IT MORE
CREDENCE.
RECOGNIZING THE UNIQUENESS IS
VERY IMPORTANT FOR US TO
EVALUATE THE KINDS OF
TREATMENTS, THE SUCCESSES AND
WHAT WORKS AND WHAT DOESN'T
WORK.
TRANSLATING IN GOAL THREE THE
IMPLEMENTATIONAL SCIENCE IS
CRITICAL AS TRAINING THE FUTURE
GENERATIONS AND EXPANDING NEW
PARTNERSHIPS.
NOW WHAT IS GOING TO DRIVE A LOT
OF OUR THINKING IS HOW WE
MEASURE OUR SUCCESS AND AS YOU
CAN SEE HERE VERY WELL
ILLUSTRATED IN THIS SCHEMATIC
THAT DRAWING FROM THE PANDEMIC
TAKING THIS DATA INTO HAND AND
DRIVING NEW INVESTMENTS IS VERY
CRITICAL FOR OUR FUTURE.
SO NOW I WANT TO GO INTO WHAT I
CONSIDER ARE THE TRANS PARADIGM
SHIFTING.
NO DOUBT DATA SCIENCE IS WHERE
-- IS THE FUTURE.
THERE ARE MANY PROGRAMS THAT ARE
GOING TO GIVE US NADCRC A HOME
TO LAUNCH FROM AND YOU'LL HEAR
IT'S ONE AREA THAT WE INTEND TO
PRIORITIZE AND WE CERTAINLY HAVE
THE FOUNDATION PIECES IN PLACE
RIGHT NOW.
AS YOU CAN SEE THROUGH THESE
VARIOUS PROGRAMS.
7 WE ALSO HAVE A VARIETY OF
TRANS NIH PROGRAMS THAT FOCUS ON
PAIN MANAGEMENT OR MISUSE
DISORDERS VERY IMPORTANT
ESPECIALLY DURING THE PANDEMIC.
I WANT TO FOCUS ON HEEL.
-- HEAL.
WE WERE ABLE TO COME TOGETHER
AND I WANT TO THANK LYNN WHO'S A
DIRECTOR OF THE CENTER FOR
COMPLIMENTARY -- OF HEALTH WHO
DROVE THIS INITIATIVE AND
LOOKING TO COME TOGETHER WITH
THE NATIONAL INSTITUTE OF NIAMS
AND A FEW OTHERS TO FOCUS ON
JOINT -- THE PATHOGENESIS OF
JOINT DISEASE AND THERE ARE TWO
MAJOR JOINTS THAT IS THE FOCUS.
LOOKING TO SEE HOW NEURAL OR HOW
INNOVATION JOINED CAN AFFECT THE
NORMAL FUNCTION AND ALSO ITSELF
DISEASE AND PROGRESS AND
DISEASE.
TRACKING NERVES DOWN GIVES US A
SENSE OF WHERE SYMPTOMS ARE
LIKELY TO EMERGE.
SO THIS INITIATIVE IS CALLED
REJOIN AND IT'S NEW TREATMENTS
FOR JOINT PAIN AND THAT RFA IS
OUT AND I ENCOURAGE YOU TO TAKE
NOTE OF THAT AND EVEN IF YOU'RE
NOT WORKING IN THE AREA.
IF YOU HAVE INSIGHTS INTO
INNOVATION AND PATHOGENESIS THIS
IS AN AREA TO INVEST IN.
VERY FORTUNATELY WE ARE HOPEFUL
THAT THERE WILL BE APPROVAL OF
AN INCREASE IN BUDGET OF WHICH
NADCRC WILL GET $18 MILLION THAT
WILL BE DEDICATED TO PAIN
RESEARCH.
WE'RE WAITING FOR THE APPROVAL
TO COME THROUGH AND WE'RE SHOVEL
READY.
AN EXAMPLE IN ONE OF THE
INITIATIVES WOULD BE CREATING A
BRAINSTORMING GROUP ON CAMPUS
THAT ACTUALLY IS HAPPENING RIGHT
NOW TO REALLY MOVE THE FIELD.
IT IS VERY DEBILITATING AND A
COMPLEX DISORDER AS YOU KNOW.
BUT I THINK IT'S THAT COMING
TOGETHER THE HOLISTIC
MULTI-DISCIPLINARY COMING
TOGETHER THAT WILL MAKE THE
BIGGER DIFFERENCE.
AMP IS ONE OF THE MOST EXCITING
PROGRAMS IN A PRIVATE PUBLIC
PARTNERSHIP FOCUSED ON THESE
VARIOUS CONDITIONS ALL OF WHICH
THAT HAVE ADVANCED IN AMAZING
WAYS AND HAS GIVEN RISE TO THE
HOPE THAT THE INFORMATION GAINED
FROM SAY SYSTEMATIC LUPUS AND
RHEUMATOID ARTHRITIS COULD BE
APPLIED TO CHILDREN'S SYNDROME.
WE DO INTEND TO FUND A PROGRAM
AND NADCRC WILL ADMINISTER THAT
PROGRAM.
SO WE EXPECT A LOT OF PROGRESS.
I WANTED TO BRING COUPLES
ANOTHER -- TO DEVELOP A PROGRAM
FOR GENE THERAPY.
THIS WILL BE APPROVED BY FDA
AHEAD OF TIME AND BE MADE
AVAILABLE SO YOU CAN PUT THE
GENE OF INTEREST AND TARGET IT
TO THE TISSUE OF INTEREST.
NOW MOST OF US IN OUR FIELD ARE
DEALING WITH CANIAL FACIAL
DISORDERS THAT ARE DEVELOPING IN
UTERO.
IT IS NOT TECHNOLOGY THAT WE CAN
READILY ACCESS RIGHT NOW.
BUT THERE ARE OTHER CONDITION
THAT'S THIS COULD BE APPLIED TO.
SO PLEASE BE AWARE OF THIS
INITIATIVE.
I WANT TO TIE THIS ALL UP TO SAY
THAT AS AMP EVOLVED WHAT I
CONSIDER CORE PROCESSES THAT IF
WE UNDERSTOOD BETTER WE WOULD
MAKE SO MUCH OF A DIFFERENCE FOR
MANY DISEASES AND ONE IS
INFLAMMATION.
TAKING A SYSTEM'S APPROACH TO
UNDERSTANDING THE INFLAMMATORY
PROCESS.
WATCHING IT CLOSELY BECAUSE
PARODONTAL DISEASE AND SEVERAL
CONDITIONS -- INVOLVE
INFLAMMATION INCLUDING THE
DOWNSTREAM CONSEQUENCES.
IT'S A VERY STEP WISE PROCESS.
IT'S JUST BEGINNING AND IT'S
GOING TO SCALE UP MANY EFFORTS
ACROSS OUR CAMPUS.
NOW WHEN I FIRST STARTED BEFORE
IT WAS AFTER GEORGE FLOYD AND
THE NATIONAL RESPONSE TO THAT
VERY TRAGIC DEATH THAT WE ALL
PAID ATTENTION TO THIS.
AND NIH WAS NO EXCEPTION.
SINCE THEN THIS PROGRAM UNITE
THAT WORKS WITH ALL OF THE OTHER
PROGRAMS ON OUR CAMPUS HAS
PUBLISHED EXTENSIVELY AND YOU
CAN SEE THESE KEY PAPERS
DESCRIBING HOW NIH IS GOING TO
TAKE THIS SERIOUSLY AND HOW
WE'RE GOING TO MOVE OUR
PROGRAMS.
THIS THINKING HAS REALLY
PENETRATED ALL OF OUR PROGRAMS
RIGHT NOW.
AND REALLY AM SO INSPIRED.
THESE ARE JUST A FEW EXAMPLES OF
THE ONGOING INITIATIVES AND ALSO
VISIBLE OFF CAMPUS ARE TRIBUTES
TO UNDER REPRESENTED GROUPS ON
OUR CAMPUS AND LEADERS AS YOU
CAN SEE HERE.
WE HAVE OUR OWN JIMMY DO WHO HAS
PLAYED A VERY IMPORTANT ROLE ON
OUR CAMPUS AND CONTINUES TO BE A
LEADER.
SO WE HAVE CHANGES IN OUR
PHYSICAL WORKPLACE AND AS
JENNIFER DESCRIBES IN THE SLIDE
SHE PUT TOGETHER A WORKFORCE IN
DENSITY IS AND THE ORAL HEALTH
SCIENCES -- PRESENTS A GOOD
OPPORTUNITY FOR MAKING A
DIFFERENCE.
AND YOU CAN LOOK AT THESE
STATISTICS.
NONE OF WHICH WOULD SURPRISE
YOU.
THIS WAS PRESENTED IN THE REPORT
TO SHOW THE PERCENTAGE OF OUR
FUNDED INDIVIDUALS IN EACH OF
THE MECHANISMS THAT WE FUND AND
YOU CAN SEE THAT WE HAVE A LOT
OF WORK TO DO.
SO HOW WE ARE BEGINNING TO
ADDRESS THIS?
AND THERE HAS BEEN A BIT OF A
LAG PERIOD BECAUSE OF TRANS NIH
POLICIES HAVE TO BE IN PLACE
BEFORE NADCRC COULD LAUNCH ANY
INITIATIVE IN THIS AREA.
WE HAVE INTENTIONAL STRATEGIES.
WE HAVE -- LOOKING AT OUR
DATASETS AND DEVELOPING A
PUBLIC/PRIVATE PARTNERSHIP WHICH
WILL BE ONE OF THE WORKFORCE
INITIATIVES TO REALLY BRING
TOGETHER THE GROUP OF
INDIVIDUALS WHO CAN INFLUENCE
WHO WE TRAIN, WHO WE ADMIT
>>> DENTAL SCHOOLS.
HOW MANY GRADUATE TRAINEES WE
INVEST IN.
AND NIDCD CANNOT DO THIS ALONE.
WE HAVE TO HAVE THE HELP OF A DA
AND OTHER ORGANIZATIONS.
EXPANDING THE WORKFORCE.
THESE ARE THE GRANTS THAT WE
FUNDED THAT ARE VERY MUCH
TARGETED TO ENRICHING OUR
PIPELINE FOR THE FUTURE.
AND THIS INCLUDES THE SUCCESSFUL
AADOCR -- PROGRAM.
THERE IS A NEED FOR US TO
ACTUALLY USE ALL OF OUR
RESOURCES TO INFLUENCE HEALTH
DISPARITIES TO GATHER THE DATA
AND TO MAKE A DIFFERENCE IN
TERMS OF CREATING OR ELIMINATING
OR REDUCING ANY BIASES AND
STRUCTURAL BARRIERS THAT EXIST
IN OUR COMMUNITY AND YOU CAN SEE
THAT THESE ARE REFLECTED HERE
WITH THESE PARTICULAR
MECHANISMS.
THESE ARE THE VERY NEW
ANNOUNCEMENTS.
THE FOAs AND NOTICES THAT ARE
OUT RIGHT NOW AND VERY SPECIFIC
AND VERY TARGETED TOPIC AREAS.
TO GAIN YOUR INPUT AND ALSO FOR
US TO BE ABLE TO INITIATE FROM
THESE DIFFERENT GRANT
OPPORTUNITIES OR FUNDING
OPPORTUNITIES.
NOTE THAT THE RESIDENCY AND
FELLOWSHIP IS OFF TO A GOOD
START AND THAT WE NOW HAVE
SELECTED THE CLASS FOR NEXT YEAR
AND THE PROGRAM WILL OPERATE
WITH ONE YEAR OF DENTAL PUBLIC
HEALTH FOCUSED CURRICULUM SO
FOLKS GET CERTIFIED AND THEN
MOVE ON TO A VERY FOCUSED TWO
TWO-YEAR EXPERIENCE.
AND AS YOU CAN SEE I'M
MENTIONING -- THE MIND THE
FUTURE AGAIN.
THEY ARE TARGETED TOWARDS
DEVELOPING A MORE COMMITTED
PIPELINE OF DENTIST SCIENTIST.
WE'RE STILL NOT THROUGH BUT IT'S
THE BEGINNING OF THE
TRANSFORMATION FOR THE TRAINING
OF SCIENTISTS FOR OUR
PROFESSION.
JANICE LEE WILL SOON MENTION THE
CLINICAL TRAINING RESEARCH
FELLOWSHIP THAT HER PROGRAM
RUNS.
THE DEADLINE IS THE 15th OF
SEPTEMBER AND IT'S BEEN
REMARKABLE TO SEE HOW THAT
PROGRAM HAS SHAPED UP UNDER
JANICE'S LEADERSHIP AND THE
IMPACT OF OUR TRAINEES NOW IN
DIFFERENT INSTITUTIONS ACROSS
THE COUNTRY AS THEY ARE PLACED
IN FACULTY POSITIONS.
IN 21 WE FUNDED THESE RFAs AND
AWARDS IN ALL OF THESE
CATEGORIES.
AND IN 22 WE HAVE RFAs OUT
HERE THAT ALSO COVER A DIVERSE
SET OF TOPICS.
THAT FOCUS BOTH ON -- HEALTH
DISPARITIES -- AS WELL AND WILL
BE FUNDING AWARDEES IN THIS
CYCLE.
WE ARE IN THE PAST HAVE APPROVED
COUNCIL -- THESE FOLLOWING
APPROACHES -- CONCEPTS.
THEY ARE ALL THERE.
AND AGAIN VERY DIVERSE.
AND WE ALSO HAVE NEW CONCEPT
CLEARANCES TODAY THAT EACH ONE
-- WHICH IS EXCITING AND I HOPE
YOU WILL BE ENCOURAGED BY THESE
EFFORTS TO MOVE OUR PORTFOLIO IN
POSITIVE WAYS.
SO NOW WHEN WE LOOK AT WHAT WE
HAVE IN TERMS OF THE SCIENCE AND
TECHNOLOGY -- GIFTS OF SCIENCE
AND TECHNOLOGY WE HAVE TO BE
THINKING OF THE OPPORTUNITIES
AND THIS CAME FROM TARA -- TALK
TO US.
WHERE CHEF TALKED ABOUT ART 8
AND THE CHALLENGES -- WHAT CAN
WE DO TO ACCELERATE THE GREAT
TRUTHS.
WE NEED THEM.
HOW CAN WE REVOLUTIONIZE THE
COUGS.
AND TRANSFORM HEALTH CARE AND
REDUCE HEALTH DISPARITIES.
THESE ARE GOALS THAT ARE NOT IN
ANY WAY FOREIGN TO US AT NADCRC.
WE'RE WELL ALIGNED WITH THESE
BROADER VISIONARY GOALS.
SHE ASKED WHAT IF WE COULD
DEVELOP mRNA VACCINES.
ZIP CODES.
WHAT ABOUT THE PLATFORM BASED
TECHNOLOGIES THAT WOULD ALLOW US
QUICKLY TO ASSESS CONDITIONS OR
LOOKING AT THE PROGRESS.
COULD WE HAVE INTERVENTIONS THAT
ADDRESS HEALTH INEQUITIES.
NONE ARE IMPOSSIBLE TO ACHIEVE.
AND THEN FINALLY SHE HAD THE
PATIENT CENTERED OR PATIENT
CONTROLLED TECHNOLOGIES THAT WE
IN DENTISTRY AND/ORAL HEALTH
VALUE TREMENDOUSLY.
NOW I WANT TO SAY THAT THE
VISION THAT I WOULD HAVE IS AS
WE INVEST -- WE'VE GOT THREE
MAJOR INITIATIVES.
IT WOULD BE LOVELY THAT IF THE
INITIATIVE -- ARE CREATING
REGENERATIVE STRATEGIES.
ONCE WE ADVANCE OUR BASIC
UNDERSTANDING OF OUR DISEASES
AND MAKE THE CONNECTIONS TO
SYSTEMATIC DISEASES THIS --
THERAPIES AND CURES TARGETED TO
TISSUE REGENERATION CAN ACTUALLY
PERHAPS BE TESTED IN THE PDRN
BUT IN THE MEANTIME HAS GROWN IN
ENROLLING DIVERSE POPULATION OF
PATIENTS AND PRACTITIONERS AND
ALMOST BEING READY TO BE
MOBILIZED SHOULD WE HAVE ANOTHER
PANDEMIC.
SO THESE ARE THE PARTS THAT WE
HAVE.
COULD -- FACE BASE MAKE IT ONE
THAT IS HOLISTIC IN NATURE WITH
DEEP PHENOTYPING DATA THAT
COVERS THE SPAN OF DISEASE
ACROSS THE LIFE-SPAN SO THAT A
CLINICIAN WANTING TO KNOW MORE
ABOUT A CERTAIN CONDITION --
COULD ACTUALLY GET GUIDANCE AND
WE COULD THEN BE DRIVEN TO
THERAPIES.
THAT IS HOW I WOULD SECRETARY -- I WOULD C ONNECT
AS WE THINK ABOUT THE FUTURE.
I WOULD LIKE TO ENGAGE COUNCIL
-- THIS IT IS THE RIGHT HAND OF
THE DIRECTOR IN MANY WAYS.
I WATCHED HOW FRANCIS COLLINS SO
WELL ENGAGED HIS ADVISORY
COUNCIL AND ON VERY KEY
SOMETIMES CONTROVERSIAL
INITIATIVES TO GET THEIR
FEEDBACK TO TAKE SERIOUSLY THE
RECOMMENDATIONS.
THAT IS HOW THEY FORMULATED.
I WOULD LIKE TO SET UP WORKING
GROUPS ON COUNCIL DRIVEN BY
COUNCIL MEMBERS.
THERE IS A STRICT PROTOCOL THAT
WE NEED TO FOLLOW AND WE WILL.
AND IN LOOKING AT THE LONG LIST
I CAME UP WITH THESE THREE THAT
SEEMED ABSOLUTELY CRITICAL RIGHT
NOW.
DATA SCIENCE FOR ORAL HEALTH
RESEARCH.
THE INTEGRATE OF TRAINING FOR
ORAL HEALTH PROFESSIONALS OF THE
FUTURE AND ENHANCING EDI FOR OUR
WORKFORCE AND THESE THREE
WORKING GROUPS WILL ENGAGE AND
BRING TO COUNCIL HOPEFULLY IN
MAY AND MAYBE SEPTEMBER COUNCIL.
A FIRM PLAN OF DIRECTORS THAT WE
CAN CONSIDER AS A GROUP.
SO, THAT IS ONE NEW CHANGE THAT
PEOPLE SEE FOR THE FUTURE.
WE ARE ALSO FINDING A LOT OF
VALUE IN ENGAGING THINK TANKS IN
AREAS OF EMERGING INTEREST AND
CONCERN.
ONE IS HPV.
SO WE DID GET A GROUP TOGETHER
LAST WEEK OF FUNDED RESEARCHERS
WHO ARE LEADING THE FIELD ALONG
WITH NED WHO KICKED IT OFF AND
VERY GRATEFUL TO -- WHO HAS BEEN
STEADFAST IN HIS SUPPORT OF
NADCRC'S PROGRAM AND WAS
INVOLVED IN THE ORGANIZATION OF
THE THINK TANK ALONG WITH JOHN
CHEN AND AMANDA -- AND LILLIAN
SHUN.
SO WE HAVE A SET OF
RECOMMENDATIONS VERY PRODUCTIVE
AND THAT WILL BE NOW PROCESSED
MORE DEEPLY SUCH THAT WE DO HAVE
A PLAN FOR ACTION IN A FEW
MONTHS AND YOU CAN IMAGINE HOW
MANY WORKING GROUP WELL THINK
TANKS CAN HAPPEN VIRTUALLY
RIGHT?
IN A MANNER THAT IS CONVENIENT
AND PRODUCTIVE FOR ALL OF US.
THAT IS ONE OF THE WAYS THAT WE
MOVE THROUGH.
SO I WANT TO THANK YOU STAFF FOR
YOUR AMAZING SUPPORT.
YOU MAKE EVERY DAY FOR ME AN
HONOR AND PRIVILEGE TO SERVE.
I HAVE MANY OF THE EXECUTIVES --
ALL OF THEM TO THANK PERSONALLY
AND YOU KNOW WHO YOU ARE AND YOU
KNOW THAT WE AS A TEAM ARE
UNBEATABLE.
AND THAT WE WILL BRING TO NADCRC
AND THE COMMUNITY THIS
UNWAVERING COMMITMENT FOR
SCIENTIFIC EXCELLENCE AND ALL
THAT WE STAND AS TRUTH.
SO THANK YOU VERY MUCH.
I WANT NOW TO INTRODUCE WITH
GREAT PRIDE A FELLOW COLLEAGUE
ELISEO -- PEREZ-STABLE: COMES
TO US WITH AGREEING TO TALK
ABOUT HIS INSTITUTE AND THE
INITIATIVES ESPECIALLY THE ONES
INITIATED DURING THE PANDEMIC.
ELISEO BRINGS EXPERTISE THAT
SPANS DECADES.
HAS DEVOTED HIS RESEARCH TO MANY
AREAS THAT INVOLVE CANCER AND
WILL HEALTH CARE IN GENERAL AND
OF COURSE HIS SERVICE JUST OVER
THE LAST YEAR -- WAS
ACKNOWLEDGED.
SO FOLLOWING ELISEO WHO WILL
TALK ABOUT THIS INITIATIVE AND
FROM WHICH WE COULD BE INSPIRED
TO DO SIMILAR THINGS IN THE NEAR
FUTURE.
WE HAVE THREE WONDERFUL
COLLEAGUES AND LEADERS.
MICHELLE CULP WHO SOME OF YOU
MIGHT KNOW.
SHE WAS PART OF OUR LEADERSHIP A
FEW YEARS AGO.
SHE HAD A BROADER PICTURE AND
WHAT NIH IS WATCHING FOR.
THERE WERE SO MANY QUESTIONS
RAISED ABOUT THE NEED FOR
[ INAUDIBLE ] IN TIMES OF
EMERGENCY.
IT'S NOT A TOPIC BUT MADE ME
THINK THAT PERHAPS WE COULD
CREATE THAT.
JANICE LEE WHO YOU KNOW HAS MADE
REMARKABLE CHANGES IN THE
PROGRAM AND HAS DEVELOPED IT TO
A POINT OF NATIONAL IMPACT.
JANICE WILL TALK ABOUT THAT
PROGRAM AND ANNA NICHOLSON HAS
HER OWN OFFICE THAT REALLY
EXTENDS THROUGHOUT THE COUNTRY.
SO I THANK ALL THREE OF YOU A
AMAZING WOMEN WHO I AM REALLY
THRILLED TO INVITE TO THE
SESSION.
SO WITH THAT DONE I DON'T KNOW
HOW WE'VE DONE TIMEWISE CAN WE
GET ELISEO ON-BOARD
>> I'M HERE.
>> WONDERFUL PRESENTATION.
THANK YOU FOR THE INTRODUCTION
AND IS A PRIVILEGE TO LISTEN TO
ANOTHER DIRECTOR PRESENT AT
COUNCIL.
BECAUSE WE DON'T GET THOSE
OPPORTUNITIES TOO OFTEN.
I WAS GLAD I WAS ABLE TO MAKE
THE TIME AND THANK YOU FOR THE
INVITATION.
GOOD IDEAS FOR MY COUNCIL NEXT
WEEK.
I WILL SHARE THE SCREEN AND MOVE
AND ADVANCE MY SLIDES.
METROPOLITAN LET ME
>> I HAD NOT MET RENA IN PERSON.
THAT IS INTERESTING.
YOU'RE ALWAYS REFERRED TO THE
COVID DIRECTORS AND CLEARLY WE
DID HAVE A ZOOM INTERVIEW.
I WAS PRIVILEGED TO DO
INTERVIEWS IN THE THIRD PHASE.
SO I'M DELIGHTED TO BE AND NIH
AND PARTNER WITH ALL OF US TO
MOVE THE AGENDA FORWARD.
SO AFTER I WAS ASKED TO TALK
ABOUT RADx BUT I THOUGHT I
WOULD GIVE A GENERAL OVERVIEW OF
NIMHD WITH SOME OVERLAPS THAT WE
HAVE WITH THE AGENDA.
I'LL START WITH OUR DEFINITIONS
OF POPULATIONS WITH HEALTH
DISPARITIES.
THE FIRST THREE BULLETS ON THE
SLIDE WAS IN OUR ORIGINAL
LEGISLATION IN THE YEAR 2000.
SO ALL RACIAL AND ETHNIC
MINORITY GROUPS AS DEFINED BY
THE CENSUS SO THAT COULD EVOLVE.
THIS IS REFERENCE TO ALL POOR
PEOPLE OF ANY COLOR.
WE ARE NOT INTERESTED IN --
INTERESTED IN POOR WHITES.
SO THE SOCIO ECONOMIC STATUS IS
IMPORTANT AND THEN RURAL
RESIDENTS.
WE QUALIFIED THAT AS THE
UNDERSERVED.
WE DECLARED SEXUAL AND GENDER
MINORITIES AS A POPULATION FOR
HEALTH DISPARITIES AFTER SEVERAL
YEARS OF WORK.
LED BY LARRY DAY BACK.
*.
WE EMBRACED A NOTION IS THAT ALL
OF THESE POPULATIONS SHARE A
SOCIAL DISADVANTAGE THAT RESULTS
FROM HAVING BEEN SUBJECT TO
DISCRIMINATION OR RACISM AND
BEING UNDERSERVED IN HEALTH
CARE.
SO A HEALTH OUTCOME THAT IS
WORSE IN ONE OF THESE
POPULATIONS IN COMPARISON TO A
REFERENCE GROUP IS WHAT WE USE
AS A DEFINITION FOR HEALTH
DISPARITY.
NOW A SECOND IMPORTANT POINT IS
THAT RACE AND ETHNICITY AS A
SOCIAL CONSTRUCT SELF-IDENTIFIED
SOCIAL CONSTRUCT AND
SOCIOECONOMIC STATUS AS A
MEASURED OUTCOME OR VARIABLE ARE
FUNDAMENTAL IN INFLUENCING
HEALTH.
THERE ARE MANY DATA THAT
INDICATE THIS AND BECAUSE OF
THIS I WOULD SAY THAT IN ALL
CLINICAL RESEARCH OR ALL
RESEARCH RELATED TO HUMAN BEINGS
AND ALL CLINICAL SERVICES WITH
HUMAN BEINGS SHOULD MEASURE
THESE AND AT LEAST CONSIDER THEM
AS INFLUENCING OUTCOMES.
WE KNOW THAT RACE ETHNICITY AND
SOCIAL ECONOMIC -- HAS LIFE --
AND MORTALITY THAT ARE NOT FULLY
EXPLAINED.
AFRICAN-AMERICANS IN THE REGARD
STUDY SAME AGE -- HAD TWO TIMES
THE NUMBER OF INCIDENT STROKES
WHEN COMPARED TO THE WHITE
COUNTERPARTS FOR THE EXACT SAME
LEVEL OF BLOOD PRESSURE UNDER
160.
ALMOST ALL CHRONIC DISEASES ARE
MORE COMMON IN PEOPLE WHO ARE
POOR AND YET THIS IS NOT REALLY
BECAUSE OF BAD BEHAVIOR.
THERE ARE MANY STRUCTURE --
ISSUES AND WITHIN A COMMON
DISEASE SUCH AS TYPE II DIABETES
--
[ INAUDIBLE ] PERSONS FROM ANY
RACIAL AND ETHNIC MINORITY GROUP
HAD LESS HEART DISEASE BY 30%
AND MORE END STAGE RENAL DISEASE
WHEN COMPARED TO THEIR WHITE
COUNTERPARTS AT 10 YEARS OF
FOLLOW-UP.
WE ALSO ACKNOWLEDGE THAT THERE
ARE MANY SOCIAL DETERMINANTS OF
HEALTH.
WE LIKE TO CALL THE INDIVIDUAL
SOCIAL DETERMINANTS OF HEALTH
INCLUDING DEMOGRAPHICS AND
FAMILY BACKGROUND.
WHERE YOU LIVE.
CULTURAL IDENTITY.
SPIRITUALITY.
LANGUAGE PROFICIENCY AND HEALTH
LITERACY PARTICULARLY IMPORTANT
AND HEALTH FUME SEE WHICH HAS
NOT BEEN STUDIED AS MUCH.
*.
IT HAS COME VERY MUCH TO
ATTENTION NOW IN PART TRIGGERED
BY THE COVID-19 PANDEMIC BUT
PRECEDING THAT AND YOU CAN SEE
HOUSING, GREEN SPACE AND ACCESS
TO BROADBAND.
ISN'T IS THAT IMPORTANT.
ECONOMIC OPPORTUNITY THAT IS
ACCESSIBLE TO WHERE YOU LIVE.
TRANSPORTATION, SCHOOLS OF HIGH
QUALITY.
HEALTHY FOOD.
AND ISSUES AROUND PUBLIC SAFETY
AND CRIMINAL JUSTICE.
IN 2018 OR 19 WE UNDERTOOK A
PROCESS THAT THROUGH THE PHOENIX
TOOLKIT PROCESS WHICH IS A
WEBSITE.
THE LINK IS LISTED THERE TO VET
WHAT WE CALLED STANDARDIZED
MEASURES OF SOCIAL DETERMINANTS
OF HEALTH.
WE GATHERED WHAT WAS ON THE
WEBSITE MOSTLY INDIVIDUAL, WE
WENT THROUGH A YEAR AND A HALF
EXPERT COMMITTEE PROCESS TO
REVIEW THESE AND WENT THROUGH AN
INITIAL PHASE I THAT WE LAUNCHED
IN MAY 2020.
WE'RE NOW UNDERGOING A SECOND
PHASE TO CONTINUE TO EXPAND THIS
LIST AND WE'RE ENCOURAGING ALL
OF OUR INVESTIGATORS THROUGH ---
[ INAUDIBLE ] TO REFER TO THIS
WEBSITE TO USE THOSE MEASURES
THAT WE HAVE.
WE ALSO DEVELOPED A RESEARCH
FRAMEWORK FOR MINORITY HEALTH
AND HEALTH DISPARITIES MODELED
IN PART ON ONE THAT I WORKED ON
WHEN I WAS ON THE NATIONAL
INSTITUTE OF AGING COUNCIL ALONG
WITH MARIE BERNARD AND CARL HILL
AND NORMAN KAPLAN.
AND IT INCLUDES NOT ONLY THE
BIOLOGICAL COMPONENTS THAT HAVE
EXPLODED IN THE LAST TWO DECADES
BUT ALSO THE PHYSICAL BUILT IN
ENVIRONMENT COMPONENTS THAT ALSO
EXPLODED IN THE LAST TWO DECADES
AS WELL AS TRADITIONAL
BEHAVIORAL ISSUES AND SOCIAL
CULTURAL ENVIRONMENT.
I THINK THE HEALTH CARE SYSTEM
IS CRITICALLY IMPORTANT IN
INFLUENCING DISPARITIES AND
OUTCOMES PARTICULARLY FOR THAT
20%-30% OF THE U.S. POPULATION
THAT HAS CHRONIC DISEASES THAT
NEEDS TO SEE CLINICIANS ON A
REGULAR BASES.
THIS FRAMEWORK IS NOT MEANT TO
BE CAUTION ALL OR COMPREHENSIVE
BUT TO GIVE A SENSE OF THE AREA
THAT THEY ARE WORKING ON THAT
MIGHT INFLUENCE HEALTH OUTCOMES
IN POPULATIONS WITH HEALTH
DISPARITIES.
IT WOULD GO FROM RIGHT TO LEFT.
AND WE'RE COMING ON A TIME WHERE
WE WANT TO REVIEW WHETHER OR NOT
THIS MAY NEED TO BE UPDATED TO
INCLUDE OTHER COMPONENTS.
TURNING TO COVID THIS IS AN A
UNANIMOUS SIS DON--ANALYSIS DONE TO LOOK A T THE
PRELIMINARY CAUSE OF DEATH FOR
THE YEAR 2020.
THERE WERE 477,000 EXCESS DEATHS
IN THE CALENDAR YEAR 2020.
THIS IS QUITE STAGGERING.
WE ALL KNEW IT BUT TO SEE THE
QUANTIFICATION IS STAGGERING.
ABOUT THREE QUARTERS ARE
DIRECTLY RELATED TO COVID.
YOU CAN SEE ABOUT A QUARTER OF
THE EXCESS DEATHS MAY NOT BE
DIRECTLY RELATED TO COVID BUT
CONSEQUENTIAL FROM THE PANDEMIC.
YOU CAN SEE THAT MALES HAD MORE
DEATHS THAN FEMALES.
AND PROPORTIONATELY LATINOS,
AFRICAN-AMERICANS, AMERICAN
INDIAN AND ALASKA NATIVES HAD
MUCH HIGHER RATES OF EXCESS
DEATHS PARTICULARLY FOR THE MEN
BUT ALSO FOR THE WELCOME PARED
TO THEIR WHITE AND
ASIAN-AMERICAN COUNTERPARTS.
AND THIS WAS IN THE ANNALS OF
INTERNAL MEDICINE.
BACK IN MAY OF 2020.
MONICA WEB HOOPER AND I
PUBLISHED A COMMENTARY IN JAMA
HIGHLIGHTING THE ISSUES OF
DISPARITIES.
THIS IS AFTER DR. FAUCI
MENTIONED IN ONE OF THE EVENING
PRESS CONFERENCES THAT WERE
BEING HELD IN LATE MARCH 2020.
LOOKING BACK 22 MONTHS LATER NOT
MUCH HAS CHANGED.
ALTHOUGH SOME PROGRESS HAS BEEN
MADE.
CASE RATES, HOSPITALIZATIONS AND
DEATHS FOR LATINOS,
AFRICAN-AMERICANS AND AMERICAN
INDIAN AND ALASKA NATIVES ARE
SOMEWHERE TWO TO THREE TIMES
THAT OF WHITES.
THESE ARE AND IT'S CONSISTENT
ACROSS THE WAY.
THE REASON CASE RATES ARE HIGHER
IS THERE IS MORE EXPOSURE AND
THE RISK IS DUE TO SOCIAL
CONDITIONS AND JOBS.
EARLY ON IN THE PANDEMIC A LOT
WAS MADE ABOUT OBESITY AND
DIABETES AND HEART DISEASE.
THOSE LEAD TO A HIGHER RATE OF
COMPLICATIONS BUT ABOUT 40% OF
LATINOS OR AFRICAN-AMERICANS
ACTUALLY HAVE TO WORK IN PUBLIC
FACING JOBS AND DO NOT HAVE THE
PRIVILEGE TO ISOLATOR WORK FROM
HOME.
AND SO WE NEED TO CONSIDER THAT
THIS EXPOSURE AND ECONOMIC AND
STRUCTURAL FACTORS ARE THE MAIN
CAUSE.
WE TALKED ABOUT LIFE EXPECTANCY
AND WHEN THE VACCINE CAME OUT
AFRICAN-AMERICAN COMMUNITIES HAD
THE HIGHEST RATE OF HESITANCY IN
THIS COUNTRY.
THAT CHANGED.
I'LL COME BACK TO THAT WITH THE
CEAL PROGRAM AND THE KINDS OF
SURVEY IN SEPTEMBER OF 2021
SHOWED THAT 70% OF BLACKS AND
71% OF WHITES AND 73% OF LATINOS
HAD RECEIVED WINDOWS.
RURAL AMERICANS AND LESS
EDUCATION AND LESS IN COLLEGE
FOR SURE ARE LEAST LIKELY
PERSONS TO RECEIVE VACCINES AS
WE WELL KNOW.
RADx WAS A HUGE PROGRAM OF
SUPPLEMENTARY PROGRAMS.
$1.4 BILLION WAS ALLOCATED TO
NIH.
THE HUGE SUCCESS OF THIS PROCESS
AND DEVELOPING THE TESTING
TECHNOLOGY LED BY THE NATIONAL
INSTITUTE OF BIOMEDICAL ENGINEER
AND BRUCE'S TEAM RECEIVED OVER
$500 MILLION.
THERE IS ALSO A PLATFORM FOR
TECHNOLOGY THAT WAS MORE READY
TO BE IMPLEMENTED.
YOU'VE PROBABLY HEARD THIS
BEFORE.
AND ALSO WHAT IS RADICAL AND
WHAT IS OUT THERE.
WHAT CAN WE DO THAT IS
DIFFERENT.
A TEST TO BE USED OR WASTEWATER.
ADVANCING THE WASTEWATER
TECHNOLOGY.
DR. COLLINS DECIDED THAT ABOUT
$500 MILLION OF THE ALLOCATION
TO NIH WOULD GO TO RADx
UNDERSERVED POPULATIONS TO
ADDRESS DISPARITIES AND THIS WAS
A REMARKABLE ACHIEVEMENT ON OUR
PART AND WE HAVE SINCE APRIL OF
2020 BEEN WORKING ON THIS
NONSTOP.
I COCHAIRED THIS PROGRAM WITH
DR. RICHARD HODES.
ANWE CONTINUE TO WORK ON THIS.
THE GOAL WAS TO ENHANCE COVID-19
TESTING.
THIS IS ALL APPROPRIATIONS FOR
TESTING.
SO WE HAVE TO STAY IN THAT LANE
AMONG UNDERSERVED AND VULNERABLE
POPULATIONS ACROSS THE U.S.
WE BASED IT ON A CONSORTIUM OF
COMMUNITY ENGAGED RESEARCH
PROJECTS SO THEY COULD IMPLEMENT
TESTING INTERVENTIONS KNOWING
THAT THEY HAD ESTABLISHED
RELATIONSHIPS WITH THEIR
COMMUNITIES.
WE WANT TO STRENGTHEN THE DATA
AVAILABLE AND IDENTIFY
STRATEGIES TO REDUCE DISPARITIES
AND SEE WHAT WE COULD DO IN THIS
AREA.
KEEP IN MIND THAT WE LAUNCHED
THIS BEFORE THE VACCINES WERE
BEING TESTED.
THAT YOU REMEMBER ALL OF THE
CHALLENGES THAT WE HAD AS A
COUNTRY INITIALLY OR -- IN
GETTING THE TESTING RIGHT.
BUT FORTUNATELY I THINK THOSE
THINGS HAVE BEEN MOSTLY WORKED
OUT.
WE HAVE NOW GONE THROUGH PHASE I
AND PHASE II.
PHASE II IS BEING LAUNCHED ON
FRIDAY OF THIS WEEK.
WITH SMALLER PROGRAM THAN WE HAD
IN PHASE I.
WE FUNDED A COORDINATION AND
DATA COLLECTION CENTER AT DUKE
NORTH CAROLINA.
AND THIS HAS BEEN AN INCREDIBLY
USEFUL RESOURCE FOR THIS
PROJECT.
IT IS LED BY THREE CO-PRINCIPLE
INVESTIGATORS.
AND WE'RE FOCUSED ON BOTH THE
TECHNICAL SUPPORT FOR TESTING
AND MONITORING EMERGING
TECHNOLOGIES AND FUNDING
RERESEARCH.
AND BY STATISTICS COMPONENT BY
WARREN WHO USED TO BE HERE.
A OF PROGRAM LED BY CORBY AT THE
UNIVERSITY OF NORTH CAROLINA.
SOME INNOVATIVE APPROACHES TO
THE EQUITY EVIDENCE ACADEMY
BEING ONE.
CREATING A COMMUNITY OF
PRACTICE.
TO GO ALONG WITH NOW NEARLY 100
PROJECTS THAT WE'VE FUNDED AND
THE COORDINATION WITH THE
ADMINISTRATION.
THE CONTACT PRINCIPLE
INVESTIGATOR MICKEY -- IS A
LATINO INFECTIOUS DISEASE
PEDIATRICIAN AND CORBY IS AN
AFRICAN-AMERICAN.
WE LOVE TO USE THESE MAPS.
WE ARE IN THE ENTIRE COUNTRY NOT
SQUARES IN EVERY STATE BUT --
RECRUITING INDIVIDUALS FROM
EVERY STATE SO THAT EXPLAINS WHY
WE LIST OVER 50.
WE DO NOTICE THAT WE'RE GOING
FROM HAWAII TO PUERTO RICO.
WE HAVE THE SOUTH PACIFIC
TERRITORIES INCLUDED FROM AWARDS
MADE IN HAWAII AND CALIFORNIA.
ABOUT 10 OF THESE AWARDS ARE
FOCUSED ON AMERICAN INDIAN AND
ALASKA NATIVE POPULATIONS.
AND WE'RE PROUD OF HOW THIS HAS
BEEN DISPLAYED.
IT'S A CHALLENGE TO GET ALL OF
THESE INVESTIGATORS USED TO
DOING WHAT THEY WANT.
ONCE THEY GET A GRANT TO WORK
TOGETHER AND TO DO THINGS
TOGETHER.
AND WE HAVE I THINK MADE HUGE
PROGRESS BUT OF COURSE THE
REALITIES NOT EVER 100% SO WE'RE
ASKING FOR COMMON DATA
ALLOCATION AND COMPLETE DATA
SHARING OF ALL OF THEIR DATA ON
A TIMELY BASES SO PROVIDING
UPLOADS EVERY WEEK OF DATA TO
THE COORDINATING CENTER AND ALSO
FOR THE REMAINING DATA AT A
DIFFERENT CADENCE.
THESE ARE THE TOTAL NUMBER OF
PROJECTS WE'VE FUNDED TO DATE.
WE HAVE A PHASE THREE THAT IS
BEING LAUNCHED SHORTLY.
*.
HOPEFULLY BY THE FIRST WEEK IN
FEBRUARY.
WE HAVE 1.2 MILLION TEST
DISTRIBUTED AND THE DATA IS MORE
UP-TO-DATE.
THIS IS AS OF JANUARY OF 2022.
WE'RE IN ALL 50 STATES AND
TERRITORIES AND THE DISTRICT.
OVER 1.3 MILLION PARTICIPANTS
HAVE BEEN ENROLLED INCLUDING
PEOPLE ABSTRACTED FROM
ELECTRONIC HEALTH RECORDS AND
THE CDC HAS CONTINUED TO GO UP
AND FUNDED SOME PILOT GRANTS AND
HAVE LISTED 48 JOURNAL ARTICLES
THAT HAVE CONDITIONA ACKNOWLEDGED THIS
FUNDING MECHANISM.
WE GET THIS UPDATE AT LEAST ON A
MONTHLY BASES.
OF CONCERN YOU CAN SEE HERE
JANUARY OF 2022 THE POSITIVITY
RATE HAS GONE UP.
THIS IS THE OMICRON SURGE.
REMEMBER THESE ARE COMMUNITY
ENGAGED PROJECTS MOSTLY NOT
SYSTEMATIC.
ALTHOUGH SOME OF THE
PARTICIPANTS ARE BEING -- ARE
SYMPTOMATIC.
AND THESE WERE UPDATED AS OF
JANUARY 11.
THE COMMUNITY ENGAGEMENT
EXPERIENCE HAS BEEN SOMETHING
YOU SNEAK ABOUT THIS PROGRAM AS
NIH HAS SUPPORTED IT.
WE HAD MANY PARTICIPANTS IN THE
UNIVERSITY OF NORTH CAROLINA LED
EQUITY ACADEMY EVENT.
MANY BREAST PRACTICES GUIDANCE
DOCUMENTS.
THE COMMUNITY COLLABORATION
GRANTS AND CHANNELS FOR
COMMUNITY OF PRACTICE.
WE HAVE COMMUNITY-BASED LEADERS
AT THE TABLE FROM THE BEGINNING
AND I'LL COME BACK TO THIS AS I
TALK ABOUT CEAL.
DEPLOYING THESE PROJECTS DURING
A PANDEMIC DOES REQUIRE ROBUST
AND TRUSTED AND EFFECTIVE
COMMUNITY PARTNERSHIPS AND I
WILL COME TO A CONCLUSION ON
THIS OR A RECOMMENDATION THAT
GARY AND RICHARD AND OTHERS WILL
PUSH FOR AS WE MOVE FORWARD IN
THE CURRENT FISCAL YEAR.
THESE ARE SOME OF THE WORK
GROUPS THAT HAVE BEEN
ESTABLISHED.
AS YOU CAN SEE THIS IS
SPONTANEOUS WORK FORCE THAT HAVE
FORMED.
LET ME SAY A FEW WORDS ABOUT
CEAL.
I WANT TO EMPHASIZE WHAT A GAME
CHANGER THIS HAS BEEN.
THIS AROSE SOMEWHAT
SPONTANEOUSLY OUT OF THE NEED TO
HAVE MORE INCLUSIVE
PARTICIPATION IN OUR CLINICAL
TRIALS PARTICULARLY WITH MODENA
BUT ALL OF THE VACCINE TRIALS IN
THE SUMMER OF 2020.
GARY GIBBONS AND A LONG WITH
FRANCIS COLLINS AND FAUCI AND
FRANCIS COLLINS MET EVERY
SATURDAY FOR ABOUT THREE AND A
HALF MONTHS TO MONITOR WHAT
MODENA WAS DOING.
OUT OF THAT CAME CEAL.
WE GAVE ADVICE AND THEY ENDED UP
WITH 37% OF MINORITIES IN THEIR
CLINICAL TRIAL FOR THE mRNA
VACCINE.
WE STOOD CEAL UP WITH MONEY THAT
WE GOT FROM DIFFERENT ICs.
MOSTLY FROM THE OFFICE OF THE
DIRECTOR AND OPERATION WARP
SPEED YOU CAN SEE THE ADDITIONS
IN 2021 HERE.
WE HAVE ONE IN THE DC MARYLAND
VIRGINIA AREA.
THESE ARE BEING DONE AND MANAGED
BY SNAP HEART AND LUNG
INSTITUTE.
WE MEET WITH OUR TEAM EVERY
OTHER WEEK.
THIS IS PRIMARILY SETTING UP
THIS COMMUNITY ENGAGED NETWORK
THAT WE SEE AS A MECHANISM A
PLATFORM THAT WE CAN LEVERAGE
FOR OTHER ISSUES.
NOT JUST PANDEMICS.
AND HOW THIS NETWORK THIS
PLATFORM WON'T DO EVERYTHING BUT
WHETHER OR NOT WE'LL SET UP
SOMETHING SIMILAR.
ADD A CLINICAL COMPONENT WHICH
WE'RE PLANNING TO DO NOW AT
LEAST TO PILOT IT.
WE STILL HAVE TO SECURE MORE
SOLID FUNDING AND THE
APPROPRIATIONS WILL BE CRUCIAL
SINCE THERE IS LANGUAGE IN THE
HOUSE AND SENATE LANGUAGE TO
SUPPORT THIS COMMUNITY
ENGAGEMENT THROUGH AN HLBI.
THIS IS BASED ON THE NOTION OF
PARTNERSHIP.
SO WE DON'T START ALWAYS WITH
THE ASK SIMIC HEALTH CENTER
RESEARCHER BUT WE BRING LEADERS
TO THE TABLE TO BEGIN WITH.
AND WE HAVE SET UP COMMITTEES
THAT ARE NOT IN THE FUNDED
PROJECTS THAT PROVIDE OVERSIGHT
OVER THE RESEARCH OF THE
INCLUSIVE PARTICIPATION OF THE
COMMUNITY ENGAGEMENT.
AND REALLY EMPHASIZES TRUST.
TRUST IN SCIENCE.
AND WHO DELIVERS THAT MESSAGE.
WE NEED TRUSTED MESSENGERS.
WE'RE STILL WELL BEHIND IN THE
COMMUNICATION SCIENCE FIELD.
WE'VE SEEN WHAT HAPPENED.
WE HAVE BUILT A GREAT VACCINE.
WE HAVE BUILT THIS WONDERFUL
HOUSE.
PEOPLE WILL COME AND GET IT.
MANY DID BUT MANY DIDN'T AND
THAT IS BECAUSE WE LET OUR GUARD
DOWN ON WHAT THE ABILITY OF THIS
INFORMATION TO REALLY CREATE
DISTRUST IN SCIENCE.
SOMETHING THAT WE WERE NOT USED
TO SEEING.
THIS IS NOT A SHORT-TERM EFFORT.
THIS IS FOR THE LONG-TERM AS WE
KNOW.
WE'RE STARTING YEAR THREE.
CEAL HAS HAD A SPECIAL IMPACT IN
OUR COMMUNICATION METRI MET -- MET
RIX.
* IT HAS WORKED HARD TO PROMOTE
AND TO COUNTER THE
MISINFORMATION.
WE NEED IS TO DO MORE IN THE
COUNTER MESSAGING THAT WE HAVE
NOT YET DONE AS MUCH ABOUT.
LET ME TURN TO ANOTHER TOPIC
THAT RENA TOUCHED ON WHICH IS
RELATED TO RACISM AND I SHOW
THIS SLIDE AT MANY TALKS.
THIS IS FROM 2015 AND IN THE
LAST 30 DAYS WERE YOU TREATED
UNFAIRLY BECAUSE OF RACE OR
ETHNIC BACKGROUND.
AND THIS IS FROM THE KAISER
FAMILY FOUNDATION.
ASIANS ARE NOT INCLUDED IN THE
RANDOM SAMPLE.
LATINOS ABOUT 36%.
AFRICAN-AMERICANS OVER HALF SAID
YES.
AND THEN IN HEALTH CARE IT
SHOULD BE AND IS MUCH LOWER.
SO WE HAVE A PROBLEM AND THIS
PRECEDED GEORGE FLOYD AND THE
PANDEMIC AND THIS IS A PROBLEM
THAT I THINK WE NEED TO
ACKNOWLEDGE AND RECKON WITH AND
BEGIN TO MANAGE MORE ACTIVELY AS
A COUNTRY AND I'M PLEASED THAT
WE'RE DOING IT ALTHOUGH THERE IS
A LOT OF RESISTANCE TO IT.
WHAT DO WE DO?
MOST OF THE WORK IS IS IN THIS
INTERPERSONAL NATURAL PHASE.
GOOD MEASURES AND THEY ARE ON
THE WEBSITE.
AND OTHER INVESTIGATORS HAVE
DONE THIS.
THE ASSOCIATIONS HAVE BEEN
ESTABLISHED MOSTLY WITH
BEHAVIORAL OR SUBSTANCE ABUSE
OUTCOMES AND SOME WITH
CARDIOVASCULAR DISEASE AND OTHER
CONDITIONS.
EARN TURN NATURALIZED RACISM.
THEY'VE INTERNALIZE EDIT -- *
THIS IS THE MODEL THAT APPLIES.
PERCEIVED SOCIETAL
DISCRIMINATION IS ANOTHER WAY OF
LOOKING AT IT.
AND THEN SECONDHAND EFFECTS OF
RACISM IS HARDLY BEEN STUDIED.
IF YOU GREW UP AROUND SOMEONE
WHO HAS BEEN HEAVILY IMPACTED BY
RACISM AND WHAT DOES THAT DO TO
YOUR HEALTH.
STRUCTURAL RACISM.
THE IDEA THAT THERE IS A HISTORY
AND CULTURE OF INSTITUTIONS.
AND PROMOTING AN IDEOLOGY.
THE CIVIL WAR DID NOT END IN
1865 AND JIM CROW DID NOT END IN
1965.
I THINK WE'RE STILL LIVING THE
CONSEQUENCES OF OUR HISTORY AND
THERE IS NO FINGER-POINTING OR
BLAME HERE.
THIS IS A MATTER OF
ACKNOWLEDGING AND PROCESSING AND
HOW CAN WE WORK TOGETHER TO MAKE
IT BETTER.
AND RESIDENTIAL SEGREGATION IS
ACORNER STONE OF THIS SYSTEM.
THIS IS A POLICY THAT WAS
IMPLEMENTED IN THE 1930s AND
PLAYED OUT AFTER WORLD WAR II
WITH THE RETURN OF DEMOBILIZED
ARMED SERVICES THAT PARTICIPATED
IN THE WAR.
REDLINING OF NEIGHBORHOODS AND
NOT ALLOW AFRICAN-AMERICANS AND
LATINO FAMILIES TO BUILD EQUITY
WHICH IS THE PRIMARY WAY
FAMILIES GROW WEALTH IN THE
UNITED STATES IS BY PURCHASING
PROPERTY AND HAVING THAT
PROPERTY GROW IN VALUE.
WE HELD A WORKSHOP IN 2017 WHERE
REALLY I WAS QUESTIONING CAN WE
REALLY STUDY STRUCTURAL RACISM
OR IS IT MORE OF AN --
ORGANIZATIONAL CONCEPT.
NOW IS THE TIME AND -- --
SUPPORTED BY ALMOST ALL
INSTITUTES AT NIH WILL BE MAKING
RECOMMENDATIONS TO OUR COUNCIL
NEXT WEEK ABOUT FUNDING
DECISIONS.
WE GOT A ROBUST RESPONSE AND I
SUSPECT WE THE AGENCY SOMEWHERE
BETWEEN -- 20-30RO1s THIS
YEAR.
THESE ARE TO GIVE YOU AN EXAMPLE
OF COMMUNITY DRIVEN
INTERVENTIONS.
PROBABLY THE MOVING TO
OPPORTUNITY STUDY IS ONE OF THE
BETTER KNOWN AND MOST EFFECTIVE
GIVING SINGLE MOMS A VOUCHER TO
MOVE TO A BETTER NEIGHBORHOOD
NOT INTENDED AS A HEALTH
INTERVENTION BUT IT RESULTED IN
LOWER A1Cs AND LOWER BMIs.
NIMHD, LET ME LEAVE YOU WITH
THESE TWO LESSONS.
HOW DO WE REDUCE DISPARITIES IN
HEALTH CARE.
NUMBER ONE IS EXPANDING ACCESS.
I KNOW THIS COMMUNITY AT NIDCR
IS KEENLY AWARE OF THIS.
BECAUSE DENTAL CARE HAS NOT BEEN
COVERED UNDERSTAND HEALTH CARE
COVERAGE.
THIS NEEDS TO CHANGE.
JUST LIKE THE EXPERIMENTED HAS
SHOWN BENEFITS.
WE KNOW THAT IF YOU GET
PREVENTIVE DENTAL CARE YOU WILL
DO BETTER.
TREATMENT OF HYPERTENSION.
WE COULD SAY FLUORIDE VARNISH IN
CHILDREN.
THERE ARE SIMILAR PARALLELS.
PREVENTING TOOTH DECAY AND
PREVENTS -- COORDINATING CARE.
PATIENT CENTERED CARE.
AND FOCUSED ON PRIMARY CARE AND
SECONDARY HOMES.
NOT JUST THE PRIMARY CARE HOME
BUT ALSO THE SECONDARY HOME.
LEVERAGING I.T. AND ELECTRONIC
HEALTH RECORDS TO ADDRESS
EQUITY.
THE MORE TECHNOLOGY THE MORE
DIGITAL THAT YOU COULD
MARGINALIZE POPULATIONS AND
WORSEN DISPARITIES.
PERFORMANCE MEASUREMENT AND RISK
NEED AND EQUITY I THINK HEALTH
CARE SYSTEMS NEED TO LOOK AT
WHAT THEIR PROFILE IS.
NOT JUST SAY DID WE DO ALL OF
THE MAMMOGRAMS.
DID WE GET THE PATIENTS OUT OF
THE HOSPITAL IN TWO OR THREE
DAYS.
BUT ALSO HOW WE'RE DOING ACROSS
AN EQUITY MEASURE.
ETHNICITY COULD BE ONE.
INSURANCE STATUS COULD BE
ANOTHER.
AND THIS IS SOMETHING THAT I
THINK I HOPE THAT CMS WILL BE
THINKING ABOUT IMPLEMENTING OR
AT LEAST THROUGH A PILOT
PROGRAM.
THE OTHER IS THE COMMUNITY
ENGAGED PLATFORM.
THIS HAS BEEN AROUND FOR A LONG
TIME.
MY CAREER BEGAN AS A
COMMUNITY-BASED INTERVENTION IN
TOBACCO CESSATION.
AT A TIME WHEN I DIDN'T KNOW
WHAT THAT WAS.
I WORKED WITH PSYCHOLOGIST AND
COMMUNITIES.
BUT WE'VE LEARNED A LOT IN THE
LAST 40 YEARS ABOUT WHAT IT
TAKES TO DO THIS.
AND I THINK THAT THE TIME IS NOW
FOR REALLY MAKING THIS A ROBUST
PLATFORM THAT CAN BE LEVERAGED
BY CLINICIAN AND TRANSLATIONAL
SCIENTIST ACROSS THE NIH FAMILY
AND THE COUNTRY.
EQUAL PARTNERSHIP IS A STARTING
POINT.
WE CANNOT HAVE SCIENTIST TELLING
COMMUNITY PEOPLE WHAT TO DO.
THEY HAVE TO WORK TOGETHER FROM
THE BEGINNING AND THAT WILL HELP
AND THEN HAVE THIS PARTNERSHIP
PUBLIC SUSTAINABLE.
LONG-TERM AND TRUSTING.
IT DOESN'T MEAN THAT YOU'RE
ALWAYS INTERACTING BECAUSE THE
OTHER ACTIVITIES INTERVENE OR
THERE IS LESS FUNDING BUT ONCE
YOU ESTABLISH THESE
RELATIONSHIPS THEY ARE
SUSTAINABLE.
I'M A FIRM BELIEVER THAT WE
SHOULD SHIFT TO POPULATIONS OF
HEALTH.
BASED ON STRONG PRIMARY CARE
INCLUDING DENTAL CARE.
RECOGNIZING THE RESPONSIBLE OF
HEALTH AND NOT JUST HEALTH CARE.
ENGAGE COMMUNITY RESOURCES IN
PROMOTING HEALTH AND THE ACCESS
TO REAL FOOD AND SAFE PLACES FOR
PEOPLE TO WALK AND EXERCISE AND
CONGREGATE.
AND NOT BE FEARFUL OF VIOLENCE
OR -- CONDITIONS.
MANAGING STRUCTURAL AND
INTERPERSONAL NATURAL RACES.
I WANTED TO TURN TO SOME OF THE
ORAL HEALTH DISPARITY ISSUES
THAT WE ACKNOWLEDGE AND TODAY
LISTEN TO RENA I WONDER ABOUT
TMJ DYSFUNCTION AND SOMETHING
THAT WE SHOULD SPEND SOME TIME
ON AT NIMHD.
THE CAVITY RATES ARE DIFFERENT.
MINORITY KIDS HAVE MUCH MORE
CAVITIES.
MORE THAN 40% OF LOW-INCOME AND
AFRICAN-AMERICAN HAVE UNTREATED
TOOTH DECAY WHICH LEADS TO MORE
EXTRACTIONSES.
AMERICAN INDIAN OR ALASKA NATIVE
HAVE THE WORSE ORAL HEALTH.
AND THIS IS AN AREA THAT WE
WOULD FOCUS ON.
ORAL CANCER ALSO AMONG
AFRICAN-AMERICANS HAVE WORSE
SURVIVAL THAN WHITES AND THEN
DENTAL THERAPEUTIC CARE IS
COSTLY.
PREVENTIVE CARE IS AFFORDABLE.
BUT MANY PEOPLE DON'T HAVE IT.
UP TO 30% OF AMERICANS AT LEAST
-- LACK DENTAL INSURANCE.
WITHOUT GOING INTO DETAILS WE DO
FUND PROJECTS IN THE DENTAL
HEALTH ORAL HEALTH DISPARITIES.
THIS IS PARTICULARLY REGARDING
THE ASSOCIATION OF PERIODONTAL
DISEASE.
THIS IS ONE EXAMPLE THAT WAS
RELATED.
ACTUALLY AN INVESTIGATOR LOOKING
AT CHANGES IN RATES OF CODEINE
AND OPIOID PRESCRIPTION AFTER
THE BLACK BOX WARNING BETWEEN
2011-2016 AND IS THIS WARNING
WAS ASSOCIATED WITH IMMEDIATE
DROP BUT DID NOT CHANGE
ALTERNATIVE OPIOID PRESCRIPTION
FILLING.
I BELIEVE THIS WAS AN R21 THAT
WE FUNDED.
LET ME FINISH WITH A PLUG.
WE STARTED THIS IN 2016.
IT WAS A TRANSITION FROM WHAT
USED TO BE A COURSE THAT WAS
OFFERED.
IT IS FREE.
ALTHOUGH THE TRAVEL WE WOULD
SUPPORT WHEN PEOPLE ARE
TRAVELING.
WE'VE HAD IT NOW VIRTUALLY AND
WE'LL WAIT TO SEE WHAT HAPPENS
IN 2022.
WE TARGET EARLY STAGE
INVESTIGATORS AND POSTDOCTORAL
FELLOWS WHO COMMIT TO SAYING IN
THEIR APPLICATION THAT THEY
WOULD BE WRITING A GRANT.
THE FEW LECTURES THAT FOCUSED ON
THE THREE THEMES OF OUR
INSTITUTE THE INTEGRATED
BIOLOGICAL SCIENCE AND
POPULATION SCIENCE AND HEALTH
SCIENCES.
THEY GET A MOCK INTERVIEW.
WE USE REAL GRANTS WITH
PERMISSION AND THIS IS A
TREMENDOUS WAY TO TEACH.
AND I WISH I HAD HAD THAT BACK
IN THE DAY.
MEETINGS WITH STAFF.
THIS IS ALLOWING THEM TO NETWORK
NOT JUST PROGRAM STAFF FROM
NIMHD BUT ACROSS THE AGENCY.
THEY ALSO GET INDIVIDUALIZED
CONSULTATIONS ON THEIR RESEARCH
INTEREST WHETHER IT BE A
PROPOSAL FOR THE APPLICATION.
WE DO A WRITING HALF DAY WITH
HELP FROM WAMC.
YOU CAN SEE THAT WE'VE HAD ABOUT
332 PARTICIPANTS OVER THE SIX
YEARS.
60% WHO HAVE COME TO OUR HEALTH
DISPARITIES RESEARCH INSTITUTE.
I DID NOT CHECK HOW MANY ARE
DENTIST.
I LOVE THIS PHOTO.
THE SCREEN SHOTS OF ZOOM
MEETINGS.
THEY DO GIVE US SOME NEW IMAGES
THAT ARE REALLY QUITE NICE.
AND LET ME JUST END WITH THIS
LIST OF SOME OF OUR CURRENT
FUNDING OPPORTUNITY
ANNOUNCEMENTS.
THESE ARE NOT SET ASIDE FOR THE
MOST PART.
THEY ARE -- THAT WE TRY TO
STIMULATE THE COMMUNITY.
THIS IS A SECOND ITERATION OF
THIS.
PATIENT CLINICIAN COMMUNICATION.
THIS JUST CAME OUT AND IT'S
BROAD.
SOCIAL ESPECIALLY GENOMICS.
WE * FUNDED ABOUT 21 GRANTS.
SLEEP DISPARITIES.
LIVER CANCER AND CHRONIC LIVER
DISEASE.
FUNDED SOME INTERESTING RO1s.
LUNG CANCER AND SCREENING AND
CARE.
HEALTH INFORMATION TECHNOLOGIES
AND HEALTH DISPARITIES.
THE STRUCTURAL RACISM AND
DISCRIMINATION.
WE HAD SET ASIDE AND HAVE NOT
DECIDED WHAT THE FOLLOW-UP ON
THAT IS.
I'M SURE MORE WILL COME.
THE MANAGEMENT OF DIABETES.
CARE OF PATIENTS WITH MULTIPLE
CHRONIC DISEASES.
AN IMPORTANT TOPIC.
AND THE ROLE OF WORK AND HEALTH
DISPARITIES AS WELL.
WE ALSO HAD A STRATEGIC PLAN
WHICH PUBLISHED LAST YEAR FOR
2021-2025.
THIS IS A STRATEGIC PLAN THAT
WE'RE CHARGED WITH PUTTING
TOGETHER FOR THE ENTIRE NIH.
THIS IS IN OUR STATUTORY
LANGUAGE.
THIS WAS CONTRIBUTED TO BY EVERY
INSTITUTE AT NIH.
WE HAD VERY GOOD PARTICIPATION
AND CONTRIBUTION FROM NIDCR TO
THIS PLAN.
SO THANK YOU FOR YOUR ATTENTION.
IF RENA LETS ME I'M HAPPY TO
ANSWER SOME QUESTIONS AND IF YOU
HAVE TIME.
>> THANK YOU, ELISEO.
IS THAT WAS INSPIRATIONAL.
I OFFER YOU HONORARY MEMBERSHIP.
THAT WAS SO INSPIRATIONAL AND
THERE ARE QUESTIONS ABOUT THE
INFRASTRUCTURE THAT YOU'VE
ESTABLISHED IN CEAL THAT IS
GROWING AND EXPERIENCING GROWING
PAINS.
COULD ORAL HEALTH BE INTEGRATED
THERE BOTH IN THE RECORD
GATHERING AND THE ACTUAL
PROGRAMS OR INITIATIVES THAT
FLOW OUT OF THIS.
>> ABSOLUTELY.
GARY GIBBONS AND I HAVE ALWAYS
HAD THESE CONVERSATIONS AND
NIHBLI IS THE BIG FELLA.
IT HAS BEEN AN ALL STAFF EFFORT
AND I COULDN'T THANK ALL OF THE
STAFF THAT HAVE BEEN INVOLVED IN
THIS IN A WAY THAT WAS
UNPREDICTED.
THIS JUST KIND OF HAPPENED AND
EVERYBODY STEPPED UP TO THE
PLATE.
IT HAS TO BE SUSTAINED.
WE WOULD LIKE TO SEE DEVELOPMENT
OF A CLINICAL COMPONENT AND THAT
MEANS FUNDING SITES THAT
COORDINATE WHAT WOULD BE THE
EQUIVALENT OF COMMUNITY-BASED
CLINICS THAT WOULD BE ABLE TO DO
A TEST, ADMINISTER A VACCINE,
AROUND THIS COVID PANDEMIC OF
COURSE.
AND SORT OF IN THE FUTURE HAVE
THAT BE LEVERAGED AS WELL FOR
OTHER FACTORS.
SO I SEE NO PROBLEM WITH
INCORPORATING ORAL HEALTH
COMPONENT IN THE FUTURE BUT CEAL
CAN'T DO EVERYTHING.
WE'RE NOT EVERYWHERE.
SO WE'RE MISSING CHUNKS OF THE
COUNTRY PARTICULARLY IN THE MORE
REMOTE RURAL AREAS IN THE WEST.
BUT I DO EXPECT THAT MORE WILL
BE FORTHCOMING AND WE WILL
PARTNER WITH OTHER INSTITUTES ON
THIS AS THESE COME UP.
WE HOPE THAT THE APPROPRIATIONS
WILL GIVE US SOME SO LID
INDICATION OF FUNDING *.
I WOULD COMMIT SIGNIFICANT FUNDS
TO CEAL AND THEN THERE IS
APPROPRIATION LANGUAGE -- TO
HAVE SUSTAINED COMMUNITY ENGAGED
ACTIVITY.
YOU CAN SEE MATERNAL HEALTH BE
ANOTHER BENEFICIARY.
WE'RE CAUTIOUSLY OPTIMISTIC
ABOUT THIS AS A PLATFORM FOR THE
FUTURE
>> THANK YOU.
I INVITE QUESTIONS.
JEN.
CAN'T HEAR YOU.
ANYONE ELSE?
THERE IS RAUL.
>> THANK YOU.
I WANT TO MAKE A COMMENT THAT 20
YEARS AGO HIS INSTITUTE AND HE
WASN'T THERE THEN BUT NIMHD WAS
ONE OF THE CO-FOUNDERS OF --
ORAL HEALTH DISPARITIES RESEARCH
CENTERS THAT HAD TWO -- SEVEN
YEAR ROUNDS OF FUNDING.
BY BUILDING A CADRE OF
SCIENTISTS.
I WAS REALLY HAPPY TO SEE A VERY
SIMILAR APPROACH THAT YOU'VE
TAKEN NOW -- CASTING A BROAD NET
TRYING TO ENGAGE MANY
COMMUNITIES AND I HOPE
CONTINUING TO HAVE A STRONG
PARTNERSHIP WITH OUR INSTITUTE
AND MOVING FORWARD.
A TREMENDOUS OPPORTUNITY FOR
ORAL HEALTH DISPARITY RESEARCH
TO INFORM YOUR OVER-ALL MISSION
AS WELL AS TO BENEFIT THE ORAL
HEALTH OF AMERICANS.
THANK YOU FOR WHAT YOU'RE DOING
AND APPRECIATE YOUR TALK
>> I DID BENEFIT FROM THE CENTER
THAT WAS AT UCSF AND WE
COLLABORATED AND SHARED SOME
FACULTY AND COLLABORATED ON A
NUMBER OF THINGS.
THANK YOU.
YES.
WE'LL CONTINUE TO WORK ACROSS
THE ENTIRE INSTITUTE AND
ESPECIALLY I HAVE TO SHOUT OUT
TO -- MARTHA WAS TERRIFIC BUT
THE NEW WAVE OF NIH INSTITUTE
DIRECTORS HAVE REALLY ENGAGED
EVERY ASPECT ACROSS THE BOARD.
SO DISPARITIES IS ON EVERYONE'S
CONSIDERATION.
SO I THINK THAT IS REALLY
IMPORTANT.
>> JUST TO SAY THAT JANE -- CEAL
PROGRAM ACTUALLY BECAME PART OF
THE STATEWIDE MANDATE.
RIGHT.
SO IT WAS VERY TRANSFORMATIVE
PROGRAM.
THANK YOU AND WE HAVE RENEE AND
JENNIFER.
WHOEVER CAN TALK OR WANTS TO.
ANYONE?
NOPE.
>> AXIL HAS HIS HAND UP.
>> YEAH.
FIRST OF ALL THANK YOU FOR THIS
OUTSTANDING PRESENTATION.
7 DEPRESSING ANDINGS STATIONAL
AT THE SAME TIME.
BUT POINTING OUT THE WORK THAT
STILL NEEDS TO BE DONE BUT ALSO
TO SEE THE FANTASTIC EFFORTS.
NOW I HAVE A MORE GENERAL
QUESTION WHICH IS -- I'M
THINKING ABOUT ALL OF THESE
DISPARITIES THAT YOU SHOWED.
SOME OF THEM PRIMARILY HAVE
THEIR CAUSE IN REAL MEDICAL
DIFFERENCES THAT ARE DRIVEN BY
GENETICS.
HYPERTENSION.
YOU SHOWED AN EXAMPLE AND THERE
ARE MORE.
AS A RESEARCHER I THINK YOU
WOULD ADDRESS THROUGH STUDY
DESIGNS LIKE YOU HIGHLIGHTED AND
DEVELOPED --
[ INAUDIBLE ] TREATMENT
APPROACHES THAT YOU TAKE THIS
INTO ACCOUNT.
AND OTHERS AS A RESULT OF THE
SOCIO ECONOMIC DIFFERENCES AND
MANY IN BETWEEN.
HOW IMPORTANT DO YOU THINK IT IS
TO REALLY TRY HARD AND
DISENTANGLE WHAT IS DRIVEN BY
GENETICS VERSUS ENVIRONMENTAL
FACTORS IN ORDER TO ADDRESS THEM
SEPARATELY.
IS THAT SOMETHING THAT IS HIGH
ON YOUR LIST OR DO YOU HAVE AN
APPROACH WHERE YOU SAY WELL WE
CAN CHANGE IT ANY WAY.
SOMETHING THAT SOCIETY NEEDS TO
CHANGE AT LARGE.
IT WON'T CHANGE IMMEDIATELY SO
SINCE WE CANNOT SEPARATE IT
WE'RE BETTER OFF TAKING A
HOLISTIC APPROACH.
TELL US ABOUT YOUR THINKING
HERE.
>> THANK YOU FOR THAT QUESTION.
AND I THINK YOU HIT ON THE --
THE FRAMEWORK WHICH WE'VE TRIED
TO CAPTURE THIS IDEA IS THAT
THERE IS NOT ONE CAUSE OF
ANYTHING.
WE KNOW THAT FROM CLINICAL
MEDICINE.
BUT YOU SEE THESE INTERACTIONS.
YOU MENTIONED HYPERTENSION BUT
IN REALITY -- I'VE GOT
COLLEAGUES THAT ARGUE IT'S NOT
GENETICS.
IT'S THE SOCIAL ENVIRONMENT OR
THE SALT THAT PEOPLE ARE EATING
THAT TRIGGERS OTHER BIOLOGICAL
MECHANISMS THAT LEAD TO THIS.
IT'S A DISCOVERY ISSUE AS WELL.
I THINK WE NEED TO BE OPEN TO
WHAT COULD BE INFLUENCED BY
BIOLOGY BY BEHAVIOR AND BY OUR
ENVIRONMENT AND TO ACKNOWLEDGE
THAT THE HISTORY OF THE
STRUCTURAL ISSUES THAT ALSO
WEIGH IN ON THESE FACTORS.
WE'RE NOT CONCEDING THAT FIELD
SO DISCOVERING MECHANISMS IS
CRITICAL AND I'M ALL FOR THAT
AND PART OF OUR RESEARCH.
BUT WE'RE NOT CONCEDING THE
STRUCTURAL FACTORS OR CHANGING
THEM AS A WAY OF INTERVENTION
AND THAT IS WHAT THE COMMON FUND
IS ALL ABOUT AND THAT COMMITMENT
FROM FRANCIS COLLINS TO SAY
WE'LL DO A COMMON FUND PROGRAM.
AND OTHERS GOT THAT GOING.
THEY ASKED ME TO JOIN WHEN THEY
SAW A WINDOW OF OPPORTUNITY.
SO I'M OPTIMISTIC THAT IF YOU
DEMONSTRATE STRUCTURAL CHANGE
AND THE MODEL OF A HEALTHY
COMMUNITY CAN BE REPLICATED.
OR WITHIN A HEALTH CARE SYSTEM.
YOU CAN HAVE EQUITABLE CARE
WITHIN A HEALTH CARE SYSTEM THAT
YOU CAN MAKE A DIFFERENCE IN
MANY OF THESE DISPARITIES AND
MANAGE THE INEQUALITIES AND WHEN
THERE IS BIOLOGY INVOLVED WE
HAVE TOOLS FOR THAT TOO.
CONTROLLING BLOOD PRESSURE.
AS A PRIMARY CARE DOCTOR IT WAS
A MATTER OF USING DRUGS AND THIS
THERAPEUTIC INERTIA BUT WHEN YOU
SEE BLACK AMERICANS HAVE THE
HIGHEST RATE OF STROKES BECAUSE
OF POORLY CONTAINED
HYPERTENSION.
YOU SAY WHY DON'T WE DO BETTER
FOR THE PEOPLE AT MOST RISK.
SOME IS IMPLEMENTATION SCIENCE.
WHAT CAN WE DO BETTER IN THAT
REGARD.
IT'S A FASCINATING FIELD.
EVERYTHING THAT YOU CAN THINK OF
AND IT'S A MATTER OF BEING
SCIENTIFIC ABOUT THE APPROACH
AND DOING MEASURES AND VARIABLES
AND BEING OPEN MINDED BY WHAT IS
THE CAUSAL PATHWAY AND NOT SET
ON NO.
THIS HAS GOT TO BE THIS OR THAT
THE.
>> BUT I THINK WHAT WOULD BE
INTERESTING TO INCORPORATE WITH
THE FRESH PERSPECTIVES THAT THE
ORAL CAVITY SERVES AS THE PORTAL
FOR ALL OF THESE THREATS.
WHETHER WHAT TAKE IN -- IN YOUR
DIET WHAT YOU'RE SMOKING OR
INHALING.
IT'S THE PORTAL TO THE REST OF
THE BODY AND YET IN ORAL HEALTH
IS SO DISCONNECTED AND WE NEED
TO BRING THAT CLOSER.
I'LL GIVE YOU ONE EXAMPLE.
MEDICAID WAS ACCEPTED BY A FEW
STATES THAT OFFERED CHILDREN 0-3
FREE DENTAL EXAMS.
50% REDUCTION IN CARRIES AND 50%
OF REDUCTION IN CARRIES FOR
LOW-INCOME FAMILIES BENEFITING
THE MOST.
IT BROUGHT PEDIATRIC PHYSICIANS
ALONG.
WE LOOK AT THE OLDER AGE GROUPS
AND IT'S BACK UP AS BEING THE
MOST COMMON REASON TO MISS
SCHOOLS.
TO GO TO THE ER AND GET DRUGS
AND THEN KIND OF FALL OFF.
IT'S A BAND DAY APPROACH SO IT
TELLS US IS HOW CAN ONE SUSTAIN
THE ENGAGEMENT SO THAT YOU MAKE
A DIFFERENCE THROUGH THE
LIFE-SPAN AND CREATE THE HEALTH
CHANGES THAT YOU NEED AND THE
BEHAVIORAL CHANGES GENERATION
AFTER GENERATION.
>> I COULDN'T AGREE WITH YOU
MORE.
IT HAS TO BE INTEGRATED AND
CLEARLY BEING A PEER EVENT AND
ALSO HAVING TAKEN CARE OF SO
MANY OLDER ADULTS I CAN SEE HOW
MUCH ORAL HEALTH CAN IMPACT
QUALITY OF LIFE, NUTRITION AND
IN ADDITION TO THE ISSUES AROUND
CHRONIC PAIN THAT YOU ALREADY
MENTIONED.
WE HAVE WORK TO DO FOR MORE
INTEGRATION.
AND I THINK LARRY TABEK WAS THE
ONE THAT TOLD ME THAT IT WAS THE
SECOND OLDEST INSTITUTE
>> WE'RE GOING TO CELEBRATE OUR
75th NEXT YEAR.
NOT HEARING ANY MORE FROM
COUNCIL I DON'T SEE ANY HANDS
RAISED WE THANK YOU FOR YOUR
TIME AND LOTS OF FOLLOW-UP AND
CONNECTIONS THAT WILL ENSUE FROM
THIS
>> THANK YOU FOR THE INVITATION
AND CONGRATULATIONS ON YOUR NEW
DEPUTY AND ALSO PLEASE SHARE MY
SLIDES.
THERE IS NOTHING SECRET IN ANY
OF THEM.
>> THANK YOU.
SALUTE.
>> LOOK FORWARD TO THAT DINNER.
>> YES.
AND RAUL YOU'RE A FELLOW CUBAN.
RURAL IS COMING TO TOWN AND WE
WILL HIT THAT RESTAURANT THAT
YOU RECOMMENDED.
>> TAKE CARE.
THANK YOU.
>> AND NOW A REAL PLEASURE TO
INTRODUCE MICHELLE CULP.
THE PRIVILEGE AND HONOR AND IT'S
BEEN SO MUCH FUN INTERACTING
WITH YOU MICHELLE IN THESE PAST
FEW MONTHS ON THE WORKFORCE.
THE CLINICAL TRIALS STEWARDSHIP.
WE LOOK FORWARD TO HEARING YOU
CAST THAT BROAD NET.
YOUR VISION FOR THE FUTURE.
>> THANK YOU RENA AND THANK YOU
FOR INVITING ME.
IT'S NICE TO SEE ON THE
PARTICIPANT LIST A FEW FAMILIAR
NUMBERS.
NADCRC WAS ONE OF THE INSTITUTES
I WORKED FOR A FEW YEARS AGO SO,
ITS NICE TO COME BACK.
THANK YOU FOR THE INVITATION.
I WILL BE TALKING ABOUT CLINICAL
TRIALS AND POLICY AND WHAT
EFFORTS ARE ONGOING.
SO LITTLE I GUESS HISTORY OR A
TIME LINE REFRESHER ABOUT WHAT
THINGS THE NIH HAS BEEN DOING TO
MAINTAIN AND IMPROVE THE QUALITY
OF CLINICAL TRIALS ACROSS THE
ENTERPRISE AT THE NIH FROM THE
POINT OF IDEA AND CONCEPT OF THE
WAY THROUGH PUBLICATION.
ROLLING BACK THE CLOCK TO
APRIL 2010.
THERE WAS AN COURT THAT MADE
SOME RECOMMENDATION THAT'S WERE
SPECIFIC TO THE NCI AND THEIR
COOPERATIVE GROUPS.
THEY MADE A NUMBER OF
RECOMMENDATIONS AND AT THE TIME
DR. COLLINS WAS OUR DIRECTOR
SAID WHY LIMIT THEM JUST TO THE
NCI.
MAYBE WE SHOULD DO MORE AND HOW
THEY CAN BE IN ARE CORPORATE --
INCORPORATED ACROSS THE NIH.
THEY PUT TOGETHER A SMALL
WORKING GROUP THAT LOOKED AT
WHAT THINGS THEY COULD DO AND
HOW THEY COULD IMPROVE THINGS
AND MADE SOME RECOMMENDATIONS
THAT I WILL TALK ABOUT IN THE
NEXT COMING SLIDES.
ONE OF THE THINGS AT THE END OF
THE TIME LINE IS NOT ONLY A
STATEMENT FROM THEN VICE
PRESIDENT JOE BIDEN ABOUT
RESULTS REPORTING IS THAT HE
STATED THAT PUBLIC FUNDS SHOULD
SUPPORT THE DISSEMINATION OF
RESULTS AND THOSE PEOPLE WHO ARE
PARTICIPATING IN CLINICAL
RESEARCH SHOULD HAVE THEIR DATA
MADE AVAILABLE.
SO THIS TIME LINE COVERS THE
WHOLE LIFE CYCLE OF CLINICAL
TRIAL DEVELOPMENT.
BACK THEN WE LOOKED AT HOW MUCH
MONEY THE NIH WAS SPENDING ON
RESEARCH AND SPECIFICALLY
CLINICAL TRIALS.
SO BACK IN 2013 THE NIH HAD
QUITE A LARGE BUDGET.
YOU'LL SEE HERE THAT WE SPENT
ABOUT 12% OF THE BUDGET,
$3.15 BILLION ON CLINICAL
TRIALS.
24 OUT OF 27 INSTITUTES AND
CENTERS THAT SUPPORTED CLINICAL
TRIALS.
AND WE HAD A TOTAL OF OVER 5,000
AWARDS THAT FUNDED CLINICAL
TRIALS.
SO WE REALIZED IT WAS A HUGE
INVESTMENT OF TAXPAYER DOLLARS
GOING INTO CLINICAL TRIALS AND
FELT WE HAD AND OBLIGATION TO
KEEP THE QUALITY OF CLINICAL
TRIALS HIGH AND TO CONTINUE TO
EXCEL.
SO THIS WORKING GROUP WAS PUT
TOGETHER BACK IN 2013 TO THINK
ABOUT WHAT THINGS COULD BE DONE
TO ADDRESS THAT REPORT BACK IN
2010 AND OTHER ISSUES THAT WERE
RECOMMENDED.
THIS WORKING GROUP PRODUCED 8
RECOMMENDATIONS.
THE FIRST AT THAT TIME WAS TO
DEVELOP A CLEAR AND
OPERATIONALLY USEFUL DEFINITION
OF THE CLINICAL TRIAL.
I THINK MOST OF YOU ARE PROBABLY
AWARE NOW THAT NIH DOES HAVE A
CLINICAL TRIAL DEFINITION.
ON THE OER WEBSITE THERE IS A
NICE GRAPHIC THAT DESCRIBES IT
AND THERE ARE SOME QUESTIONS
THAT HELP LEAD RESEARCHERS TO
UNDERSTAND WHETHER THEIR STUDY
IS A CLINICAL TRIAL.
THE OTHER THE SECOND
RECOMMENDATION WAS TO IMPROVE
THE EFFICIENCY OF IRB REVIEW.
AT THAT TIME WE MULTIPLE IRBs
WERE LOOKING AT A SINGLE
CLINICAL TRIAL OR CLINICAL STUDY
AND WE WERE GETTING MULTIPLE IRB
REVIEWS SO THE RECOMMEND IS TO
LOOK AT EFFICIENCIES AND THE
RESULTS WERE A SINGLE IRB
POLICY.
THE THIRD RECOMMENDATION WAS TO
ENHANCE THE RELEVANCE AND
FEASIBILITY OF NIH FUNDED
CLINICAL TRIALS.
THE FOURTH WAS INCREASE
KNOWLEDGE AMONG INVESTIGATORS
AND TAFF.
A POLICY WAS GENERATED FROM
THAT.
*.
ALSO TO ENHANCE THE INFORMATION
COLLECTED IN PROGRESS REPORTS.
AND YOU PROBABLY ARE AWARE OF
SOME OF THOSE ENHANCEMENT MADE
IN THE FORMS THAT OER HAS PUT
OUT.
THE 6th WAS TO DEVELOP
SOPHISTICATED WEB BASED TOOLS
FOR MONITORING.
THIS REQUIRED A LOT OF IT
SUPPORT AND ADDING ADDITIONAL
FORMS AND DATABASES TO HELP THE
NIH AND RESEARCHERS TO TRACK AND
MONITOR CLINICAL TRIALS.
WE HAVE WANTED TO ENHANCE
CLINICAL TRIAL RESULTS AND
MAKING SURE THAT THE RESULTS
THAT CAME FROM CLINICAL TRIALS
WERE MADE AVAILABLE TO THE
PUBLIC.
AND LASTLY WAS TO HAVE A MORE
RIGOROUS PIE -- PEER REVIEW AND HAVE
MORE DETAIL.
SO WHAT THE GOALS OF THE 2016
STEWARDSHIP REFORM POLICIES WERE
TO IMPROVE THE QUALITY AND
EFFICIENCY OF CLINICAL TRIALS.
WE WANTED TO SUPPORT TRIALS
INVESTIGATING -- MISSION
RELEVANT QUESTIONS AND HIGH
PRIORITY.
JUST TALKING ABOUT WHAT THOSE
FORMS MEANT WITH REGARD TO THE
LIFE CYCLE.
TAKING THIS LIFE CYCLE OR
JOURNEY APPROACH WE THOUGHT
ABOUT THE WAY IDEAS ARE
CONCEIVED AND HOW AN IDEA COMES
IN AND IN ORDER TO IMPROVE HOW
WE'RE THINKING ABOUT CLINICAL
TRIALS AND MANAGING IT WE FELT
THAT BEING SURE THAT
INVESTIGATORS AND THOSE MANAGING
CLINICAL TRIALS HAD A BETTER
UNDERSTANDING OF CLINICAL
TRIALS.
THUS WE DEVELOPED A POLICY THAT
REQUIRES GOOD CLINICAL PRACTICE
TRAINING.
WE ALSO INSTITUTED A POLICY FOR
CLINICAL TRIAL FUNDING
OPPORTUNITY A NOUNSMENTS AND
HAVE SENSE REQUIRED THAT
CLINICAL TRIALS COME IN THROUGH
A SPECIFIC FUNDING OPPORTUNITY
AND THAT THOSE APPLICATIONS HAVE
SPECIFIC ITEMS IN IT SO THAT
REVIEWERS CAN BETTER EVALUATE
THE CLINICAL TRIAL.
ON THE FLIP SIDE THERE ARE
ADDITIONAL CLINICAL TRIAL REVIEW
CRITERIA THAT PANELS MUST
FOLLOW.
WE INSTITUTED A SINGLE IRB
POLICY.
---STATES THAT MULTI SITE
CLINICAL TRIALS OR STUDIES WILL
USE A SINGLE IRB.
WE ALSO RELEASED A PROTOCOL
TEMPLATE WHICH WAS NOT REALLY
PART OF THE REFORMS BUT THE
TIMING WAS SUCH THAT IT PROVIDED
A RESOURCE TO HELP INVESTIGATORS
DEVELOP CLINICAL TRIAL PROTOCOLS
IN ACCORDANCE WITH ICH6.
INCLUDING ALL OF THE LIMITS
NECESSARY.
WE ALSO RELEASED THE POLICY FOR
CLINICAL TRIAL REGISTRATION OR
RESULTS REPORTINGS WHICH MEANS
THAT ALL NIH FUNDED CLINICAL
TRIALS MUST REGISTER AND THAT
RESULTS MUST BE REPORTED TO
CLINICAL TRIALS.GOV WITHIN 12
MONTHS OF THE TRIAL'S PRIMARY
COMPLETION DATE.
SO THAT COVERS FROM THE LIFE
CYCLE OF CLINICAL TRIAL IDEA ALL
THE WAY THROUGH CLINICAL TRIAL
REGISTRATION AND REPORTING.
SO THIS IS JUST A LITTLE BIT
MORE CLARITY ON THE POLICIES
THAT HAVE -- WERE RELEASED BACK
IN 2016 BUT A NUMBER OF THEM
WERE NOT EFFECTIVE UNTIL 2017 OR
EARLY 2018.
I HOPE MOST OF YOU ARE AWARE OF
THEM AND IF YOU'VE SUBMITTED
CLINICAL TRIALS HAVE FOLLOWED
THOSE POLICIES AND ARE WELL
INFORMED I'M HAPPY TO TALK ABOUT
THEM IN GREATER DETAIL IF YOU'RE
INTERESTED.
NEXT SLIDE.
SO WHEN WE THINK ABOUT RESULTS
REPORTING FRANCIS COLLINS AND
THE NIH ARE VERY COMMITTED TO
BEING SURE IS THAT RESULTS OF
STUDIES ARE MADE AVAILABLE
QUICKLY.
WHILE THE CLINICAL TRIALS
DISSEMINATION POLICY STATES THAT
RESULTS MUST BE REPORTED WITHIN
ONE YEAR OF THE PRIMARY
COMPLETION DATE OF CLINICAL
TRIALS IN NOVEMBER OF 2020
DR. COLLINS WAS REALLY EMPHATIC
ABOUT ENSURING THAT RESULTS OF
COVID STUDIES WOULD BE REPORTED
AS QUICKLY AS POSSIBLE.
THIS WAS NOT A REQUIREMENT
CHANGE BUT A PLEA TO THOSE
RESEARCHERS WORKING ON COVID
STUDIES TO QUICKLY REPORT
RESULTS TO CLINICAL TRIALS.GOV
SO OTHER RESEARCHERS WOULD BE
AWARE AND THE PUBLIC WOULD HAVE
THE LATEST RESULTS INFORMATION.
SO THIS IS JUST AN EXAMPLE OF
NIH'S COMMITMENT TO RESULTS
REPORTING.
AS WE MOVE FORWARD BECAUSE WE
HAVE PUT OUT A NUMBER OF REFORMS
IN THE LAST FIVE YEARS
DR. COLLINS CONTINUED TO SUPPORT
STEWARDSHIP AND WANTED TO BE
SURE IS THAT WE WERE DOING ALL
THAT WE COULD BE IN ENSURING THE
QUALITY OF CLINICAL TRIALS AND
SEE IF THERE ARE OTHER EFFORTS
THAT COULD BE DONE.
CERTAINLY COVID HIGHLIGHTED A
NUMBER OF AREAS WHERE
IMPROVEMENTS COULD BE MADE BUT
LOOKING AT THE FUNDING OVER THE
LAST SEVERAL YEARS YOU'LL SEE
WHEN WE STARTED THE REFORMS IN
2013 AND THINKING ABOUT OUR
BUDGET AT $3 BILLION WHEN YOU
LOOK AT THE ESTIMATED BUDGET OF
2021 THE NIH BUDGET HAS DOUBLED
SINCE THEN.
AND SO WE FEEL THAT WE HAD A
CONTINUED NEED TO BE SURE IS
THAT WE WERE PROVIDING THE BEST
STEWARDSHIP FOR CLINICAL TRIALS
IN KEEPING THOSE TRIALS OF THE
HIGHEST QUALITY.
SO WITH THAT THIS CLINICAL TRIAL
STEWARDSHIP EFFORT CONTINUES AND
WITH THE TASK FORCE FORMED LAST
SUMMER RENA IS ONE OF THE TASK
FORCE MEMBERS AS IS JANICE LEE
SO WE'RE ABLE TO GET INPUT FROM
HIGH LEVEL LEADERSHIP ACROSS THE
NIH THAT INCLUDES BOTH
EXTRAMURAL AND INTERMURAL INPUTS
WHERE WE CAN ASSESS THE POLICIES
THAT WERE DEVELOPED IN 2016 ARE
MEETING THE INITIAL GOALS AND
ALSO TO LOOK TO SEE HOW WE MAY
BE ABLE TO IMPROVE OR FIND GAP
AREAS FOR AND WHAT MORE WE MIGHT
BE ABLE TO DO TO IMPROVE
CLINICAL TRIALS.
SO I JUST WANTED TO IN CLOSING
WITH THE STEWARDSHIP IT'S
ONGOING TO SEE THAT WE'RE
IMPROVING CLINICAL TRIALS AND
PULLING TOGETHER RECOMMENDATIONS
FROM A NUMBER OF AREAS AND I
GUESS STAY TUNED TO SEE WHAT
THOSE RECOMMENDATIONS WILL BE
AND HOW WE CAN TAKE ACTION ON
THEM ACROSS THE ENTERPRISE.
I WANT TO SHIFT GEARS A LITTLE
BIT BECAUSE LISTENING ABOUT THE
CEAL INITIATIVE AS WELL AS
HEARING CONTINUES ACROSS THE
CLINICAL TRIAL EVENT SURPRISE
ABOUT WHAT * THINGS WE MIGHT
DOING IMPROVE CLINICAL TRIALS.
WE PULLED TOGETHER SOME LESSONS
LEARNED FROM A NUMBER OF SOURCES
INCLUDING THE INSTITUTE THAT PUT
OUT A PUBLICATION -- THE
NATIONAL ACADEMIES HAS HAD A
DIRECT FORUM SERIES.
AND THEN OPERATIONAL WARP SPEED
AS WELL AS SOME OTHER GROUPS DID
A PRESENTATION AT THE REAGAN
UDAL FOUNDATION TALKING ABOUT
LESSONS LEARNED.
SO I JUST WANTED TO HIGHLIGHT
SOME OF SHOWS LESSONS LEARNED.
7 START WITH CLINICAL TRIAL
DESIGN WHICH IS AT THE BEGINNING
OF THE CLINICAL TRIAL LIFE
CYCLE.
WHAT ARE THE THINGS THAT WE
COULD DO AND HOW WE CAN
CO-DESIGN CLINICAL TRIALS WITH
PATIENT ADVOCATES AND UNDER
REPRESENTED COMMUNITIES SO THEIR
NEEDS ARE BASKETBAL BETTER A LINED.
WE WOULD LIKE TO SEE IS THAT
CLINICAL TRIAL DESIGN ARE
IMPROVED TO ELIMINATE UNDER
POWER TRIALS THAT DO NOT
CONTRIBUTE TO ADVANCING
KNOWLEDGE AND TO USE METHODS TO
LIMIT CONDUCT OF CLINICAL TRIALS
THAT ARE NOT DESIGNED TO PRODUCE
ROBUST DATA.
AND THE FOA POLICY THAT'S AN
AREA THAT WE'RE TRYING TO BE
SURE IS THAT CLINICAL TRIALS
THAT ARE FUNDED CAN PRODUCE
ROBUST DATA.
THINKING ABOUT DESIGN AGAIN WAYS
IN WHICH WE CAN USE MORE --
ADAPTIVE TRIAL DESIGNS IN WHICH
PATIENTS ARE SUBJECTED AND THEN
TO PROMOTE THE DEVELOPMENT AND
OPERATIONAL -- OPERATIONS OF
EFFICIENT LARGE SCALE LYNN CAL -- SCALE
CLINICAL TRIALS NETWORK.
I THINK THAT ELISEO TOUCHED ON
THIS BUT HE IS NOT ALONE.
THEY'VE MADE RECOMMENDATIONS ON
HOW WE MIGHT BE ABLE TO INVEST
IN COMMUNITY OUTREACH AND
ENGAGEMENT EARLY IN THE CLINICAL
TRIAL PROCESS.
THIS IS NOT ASKING FOR
ENGAGEMENT WHEN THE TRIAL IS
FAILING TO RECRUIT.
BUT EARLY IN THE STAGES OF
DESIGNING THE TRIAL SO THAT
THEIR NEEDS ARE ADDRESSED AND
THAT THEY CAN BE AWARE OF
CLINICAL TRIALS -- HE SAID THAT
WE MOVE AT THE SPEED OF TRUST SO
BY CULTIVATING WE CAN IMPROVE ON
THE TRUST.
THEY ARE AT THE TABLE AND SEEN
AS A PARTNER WHERE THEIR INPUT
IS VIEWED AS EQUAL TO THE OTHER
TEAM MEMBERS IN DEVELOPING IDEAS
THAT ADDRESS THE COMMUNITY'S
NEEDS AND TO ENGAGE A DIVERSE
CLINICAL RESEARCH TEAM MEMBERS
THAT REPRESENT THE POPULATIONS
AND HAVE ALL TEAM MEMBERS BE
REPRESENTATIVE SO THAT WE ARE
SURE THAT THE DIFFERENT ROLES
CAPTURE DIFFERENT POPULATIONS.
MORE ABOUT DIVERSITY.
WE WANT TO IMPROVE THE DIVERSITY
IN CLINICAL TRIALS.
THERE ARE POLICIES THAT THE NIH
HAS ABOUT INCLUSION OF WOMEN AND
CHILDREN.
RACIAL ETHNIC MINORITIES AND
INCLUSION OF PARTICIPANTS ACROSS
THE LIFE-SPAN BUT THIS IS REALLY
ALSO TO DETERMINE THE BEST
PRACTICES FOR INCREASING
PARTICIPATION IN CLINICAL TRIALS
FROM UNDER REPRESENTED
COMMUNITIES AND TO CREATE ACTION
PLANS FOR IMPROVING DIVERSITY IN
CLINICAL TRIALS.
RECOMMENDATIONS INCLUDED
ENSURING DIVERSE FACULTY
PROMOTION.
EQUITABLE AND INCLUSIVE
WORKFORCE TRAINING PROGRAMS AND
PROFESSIONAL DEVELOPMENT
OPPORTUNITIES FOR DIVERSE
POPULATIONS.
ANOTHER THOUGHT ABOUT DIVERSE IN
CLINICAL TRIALS IS MAKING
TELEHEALTH OR TELL RESEARCH AND
ELECTRONIC VISITS MORE VISIBLE
INCLUDING NOVEL AND EQUITABLE
DATA COLLECTION METHODS AND
ACTUALLY SOMEWHAT CURIOUS ABOUT
HOW THE DENTAL COMMUNITY IS ABLE
TO INTEGRATE ELECTRONIC HEALTH
RECORDS INTO RESEARCH AND TO BE
ABLE TO UTILIZE TELL RESEARCHER,
TELEHEALTH IN CLINICAL TRIALS.
SO DECENTRALIZED CLINICAL TRIALS
HAS GOTTEN A LOT OF BUZZ.
IT CAN TAKE ON A NUMBER OF
DIFFERENT DEFINITIONS WHETHER
THEY BE TELEMEDICINE OR
TELEHEALTH TYPE OF TRIALS OR
PRAGMATIC CLINICAL TRIALS BUT
THINKING THAT WE NEED TO THINK
ABOUT WAYS TO REMOVE BARRIERS
EXPAND ADOPTION OF THESE TRIALS
SO THAT PATIENTS ARE NOT ALWAYS
HAVING TO COME INTO AN ACADEMIC
HEALTH CENTER TO GET THEIR STUDY
VISITS COMPLETED.
AND TO THINK ABOUT WAYS IN WHICH
WE CAN MONITOR CLINICAL TRIALS
MORE REMOTELY.
HOW WE CAN ALIGN REMOTE DATA
COLLECTION STANDARDS SO THAT
DATA CAN BE PULLED FROM OTHER
SOURCES NOT JUST THE SINGLE
RESEARCH SITE.
EXTEND TELEMEDICINE IN REMOTE
MONITORING FOR FLEXIBILITIES AND
REIMBURSEMENT BEYOND PUBLIC
HEALTH EMERGENCY.
WE SAW A LOT OF THAT CHANGE
DURING COVID WHERE PEOPLE HAD TO
MAKE THOSE CHANGES BECAUSE THEY
WERE NOT ABLE TO COME IN FOR
THEIR VISITS AND THEY HAD TO BE
DONE THROUGH OTHER TECHNOLOGIES.
HOW CAN WE SUSTAIN THOSE TYPES
OF TECH SNEAKS AND METHODS IN
THE FUTURE FOR ANY CLINICAL
TRIAL.
DEMONSTRATE THAT CONDUCTING
CLINICAL TRIAL -- CONDUCT
TECHNOLOGY ABLED DECENTRALIZED
TRIALS -- WE WERE FORCED TO DO
THESE THINGS BUT LOOKING AT HOW
WE CAN BE SURETY HIGHEST DATA
QUALITY AND THE VALIDITY OF THE
DATA WE RECEIVED.
THAT'S AN AREA THAT WE NEED TO
THINK ABOUT.
SO THIS LEADS INTO THE DIGITAL
RESEARCH TECHNOLOGIES AND WAYS
IN WHICH WE CAN USE TECHNOLOGIES
TO SUPPORT CLINICAL TRIALS.
AND APPLY THOSE TECHNOLOGIES TO
SIMPLIFY CLINICAL TRIALS AND
IMPROVE THE PATIENT EXPERIENCE
USING DIGITAL HEALTH
TECHNOLOGIES TO ENABLE DIRECT
INTERACTION WITH PATIENTS AND
POTENTIAL TRIAL PARTICIPANTS TO
GAIN THEIR INPUT NOT ONLY ON
THEIR IDEAS FOR DEVELOPING
CLINICAL TRIAL RESEARCH
QUESTIONS BUT ALSO TO HELP
PROVIDE THE DATA.
SO THERE IS THEN EXPERIENCE IN
USING CROWD SOURCING AND OTHER
TECHNOLOGIES TO GATHER INPUT OR
COMMUNITY ENGAGEMENT IN PATIENT
INPUT ON TRIAL DESIGN BUT HOW
CAN WE ALSO USE THOSE TYPES OF
TECHNOLOGIES TO GATHER CLINICAL
DATA FOR THE STUDIES.
USING SELF-REPORTED DATA
COLLECTION TOOLS IS ANOTHER WAY
IN WHICH WE CAN USE RESEARCH
TECHNOLOGIES.
AND THEN UTILIZING ANALYTICS AND
ARTIFICIAL INTELLIGENCE, MACHINE
LEARNING TO GENERATE FASTER AND
MORE RIGOROUS SYSTEMATIC
REVIEWS.
THEY ARE USING ELECTRONIC
SOURCES TO ANSWER RESEARCH
QUESTIONS.
THERE ARE OTHER INITIATIVES
ACROSS THE NIH THAT ARE USING
ARTIFICIAL INTELLIGENCE AND
SYNTHETIC DATA TO ANSWER.
THESE ARE TECHNOLOGIES THAT
COULD HELP ADVANCE THE WAY THAT
WE DO CLINICAL TRIALS TO
PRESERVE OUR RESOURCES IN AREAS
SO THAT WE CAN IMPROVE QUALITY
AND IMPROVE THE DESIGN OF
CLINICAL RESEARCH.
.AND THEN LASTLY DATA COLLECTION
AND DATA TRANSPARENCY.
USING REAL WORLD DATA OR REAL
WORLD EVIDENCE TO EXPLORE HEALTH
INEQUITIES.
ENSURING EQUITABLE DATA
COLLECTION AT CLINICAL TRIAL
SITES AND MAKING USE OF REAL
WORLD EVIDENCE.
SO THAT WE ARE UNDERSTANDING
WHAT THE JOURNAL EDUCATORS ARE
LOOKING FOR AND THAT THEY CAN
HELP FACILITATE PUBLICATION OF
TRIAL RESULT DATA NOT JUST THE
SUMMARY DATA BUT ALSO SUPPORTING
THE DATASET AND PUBLICATION OF
THE DATA.
SO THOSE ARE JUST SOME THOUGHTS
ON WAYS IN WHICH WE CAN BE
THINKING ABOUT TECHNOLOGY AND
OTHER LESSONS LEARNED THROUGH
THE LAST TWO YEARS TO IMPROVE
THE CLINICAL TRIAL ENTERPRISE.
I'M HAPPY TO TAKE QUESTIONS OR
AND THANK YOU FOR YOUR
ATTENTION.
7
>> THANK YOU, MICHELLE.
THAT WAS AGAIN SO WELL INFORMED
AND INFORMATIVE FOR US.
THIS IS AN AREA THAT WE HAVE
MULTIPLE OPPORTUNITIES TO
ADVANCE?
AND I CAN SEE THAT FROM ELISEO'S
MODEL AND PERHAPS I'LL BE BOLD
TO SUGGEST CREATING A NATION
WIDE NETWORK OF COMMUNITY
ENGAGEMENT SUCH THAT CLINICAL
TRIALS CAN BE HELD IN LARGER
SCALE TO YOU GIVING US A STATUS
OF THE SCIENCE OF WHERE WE
SHOULD BE GOING AS THE PANDEMIC
HAS POINTED TO US HAS BEEN VERY
VALUABLE.
I SNOW THERE WILL BE PEOPLE
ASKING QUESTIONS BUT ORAL HEALTH
RECORDS IN GENERAL ARE NOT WELL
INTEGRATED RIGHT NOW.
WE HAVE INTERFACE PROGRAMS
WORKING IN SOME AREAS.
CERTAINLY ACADEMIC INSTITUTIONS
ARE TRYING AND LEADING THE
EFFORT BUT THERE IS LOTS OF ROOM
IN TERMS OF INTEGRATING NOT JUST
HEALTH CARE PRACTICES BUT
SHARING DATA ON PATIENTS SO WE
HAVE A MORE HOLISTIC APPROACH
AVAILABLE FOR OUR CLINICAL
TRIALS RESEARCH.
SO I INVITE ANYONE FROM COUNCIL
WHO HAVE ANY QUESTIONS TO ASK
MICHELLE SPECIFICALLY AS WE GOES
INTO THE MORE NADCRC TOPICS.
8 JENNIFER, ARE YOU HOOKED ON?
NO.
>> CAN YOU HEAR ME?
>> YES.
>> OKAY.
I AGREE WITH RENA AND I VERY
MUCH APPRECIATE YOUR TALK.
THERE IS A WISDOM MODULE WITHIN
EPIC BUT THAT IS GOING TO TAKE
SOME TIME.
THE UP TAKE HAS IS NOT BEEN HUGE
YET BUT IT IS COMING DOWN THE
ROAD SO THAT MAY OFFER A
SIGNIFICANT AREA OF OPPORTUNITY.
>> YES.
>> RENA I THINK THAT IN SOME
WAYS NIDCR HAS A UNIQUE
OPPORTUNITY TO ENGAGE THE
COMMUNITY THROUGH YOUR PRACTICE
BASED RESEARCH NETWORK WHO ARE
ENGAGED IN I GUESS PRAGMATIC
CLINICAL TRIALS SIMPLE TRIAL
DESIGNS BUT BEING ABLE TO INFORM
THEIR COMMUNITY ABOUT RESEARCH
AND ALSO TO HELP INFORM YOUR
PRACTITIONERS ABOUT RESEARCH SO
THAT RESEARCH BECOMES PART OF
THE HEALTH CARE SYSTEM AND THAT
RESEARCH IS SEEN AS QUALITY
IMPROVEMENT AND QUALITY CARE NOT
I THINK AN EXPERIMENT.
BUT SOMETHING WHERE ALL OF THOSE
PRACTITIONERS AND THE PATIENTS
IN THE PRACTICES CAN FEEL THAT
THEY ARE CONTRIBUTING TO
ADVANCES IN SCIENCE AND IMPROVES
HEALTH CARE
>> AND PARALLEL TO THAT IS THE
EVOLUTION OF OUR DIGITAL
TECHNOLOGY WHERE WE HAVE 3-D
PRINTING AND SCANS THAT WOULD
MAKE PROCEDURES MOVE FASTER FOR
PATIENTS THAT ARE ALL DIGITAL
RECORDS THAT COULD BE MINED IF
WE DID HAVE AN INTEGRATED
SYSTEM.
ANYONE FROM COUNCIL WITH
ADDITIONAL COMMENTS OR QUESTIONS
OF MICHELLE.
I'M LOOKING AT THE GUESTS.
WE HAVE A WHOLE HOST OF
LISTENERS AND IF THERE ARE ANY
YOU.
THANK YOU VERY MUCH FOR TAKING
THE TIME TO DO THIS.
VERY VALUABLE INDEED.
>> YOU'RE WELCOMED.
THANK YOU.
>> AND NOW IT'S GREAT TO MOVE ON
TO WHERE NIDCD IS RIGHT NOW OF
PATIENT ORIENTED CARE AND IT'S A
GREAT PLEASURE FOR ME TO
INTRODUCE JANICE LEE WHO WILL
SHORTLY HAVE HER PRESENTATION
UP.
JANICE AS YOU KNOW -- SHE CAME
TO NIDCD ABOUT SIX OR SEVEN
YEARS AGO.
SEVEN TO EIGHT YEARS AGO.
SHE IS AN ORAL SURGEON AND MD
AND DDS WITH A MASTERS DEGREE.
AND JANICE CAME?
TO A SYSTEM THAT WAS NOT VERY
WELL DEVELOPED AT THE TIME AND
HAS REALLY TRANSFORMED THE
OFFICE OF THE CLINICAL DIRECTOR.
HER PRESENCE IS TRULY
TRANSFORMATIVE FOR OF THE CAMPUS
BECAUSE SHE IN ADDITION TO THIS
ROLE WIT NIDCR IS INVOLVED CAMPUS
WIDE DEPARTMENT OF CLINICAL
CARE.
JANICE IS ASSOCIATE DIRECTOR AND
WORKED WITH MIKE AND IS
EXTREMELY VALUED AND RECOGNIZED
ACROSS CAMPUS.
THANK YOU JANICE AND PLEASURE
WILL BE -- NICE TO HEAR YOU AND
YOUR OVERVIEW.
>> THANK YOU.
ANNA DID YOU WANT TO PUT UP OUR
SLIDES?
>> THAT WOULD BE GOOD.
>> A CORRECTION.
I DID PUT SECOND OF FEBRUARY AS
THE DATE FOR THE AADOC WEBINAR.
IT IS MEANT TO BE THE FIRST OF
FEBRUARY.
THE SECOND OF FEBRUARY IS MY
WEDDING ANNIVERSARY.
SO APOLOGIES.
IT IS THE FIRST OF FEBRUARY AND
THERE IS INFORMATION ABOUT THE
WEBINAR ON THE WEBSITE.
>> GREAT.
THANK YOU VERY MUCH.
DR. D DESOUZA.
THANK YOU FOR INVITING ANN AND
MYSELF TO PRESENT TO YOU ABOUT
SOME OF THE OPPORTUNITIES AND
SUCCESSFUL IMPLEMENTATION.
IT'S IN KEEPING WITH THE
PREVIOUS THEME OF CLINICAL
TRIALS AND IT'S A PLEASURE TO BE
SANDWICHED BETWEEN MICHELLE AND
ANN.
I THINK WHAT I'M GOING TO DO IS
PULL BACK THE CURTAIN FOR THE
COUNCIL AND FOR THE AUDIENCE TO
SEE EXACTLY HOW ARE WE ABLE TO
DO THIS?
AND I'M REALLY PLEASED THAT I
HAVE THIS COORDINATED
PARTNERSHIP WITH ANNA BECAUSE IF
IT WAS NOT FOR THIS COORDINATED
PARTNERSHIP I DON'T THINK WE
COULD SUCCESSFULLY IMPLEMENT AND
AGAIN MICHELLE AND JIM BEFORE US
ARE TO THANK FOR THE FOUNDATION
THAT THEY'VE LAID BEFORE US.
SO YOU DID HEAR FROM DR. DESOUZA
THE STRATEGIC PRIORITIES OF THE
NIDCD.
WOULD -- NIDCR.
SHE TOO GAVE US A VISION FOR THE
PROGRAM DURING A RECENT TOWN
HALL.
WHAT I DO WANT TO POINT OUT THE
KEY WORDS IN STRATEGIC PRIORITY
3 WORDS LIKE ACCELERATE AND
WE'VE TRIED TO REDUCE EVERY
BARRIER POSSIBLE TO ALLOW US TO
ACCELERATE BECAUSE THAT IS WHAT
WE'RE USING TO TRANSLATE.
TAKING THINGS FROM THE BENCH TO
THE CHAIR SIDE.
WE ALSO WANT TO BE SURE THAT
WE'RE IMPLEMENTING THE HIGHEST
QUALITY RESEARCH AS WELL AS
REPRODUCIBLE STUDIES.
SO MY OFFICE THE OFFICE OF
CLINICAL DIRECTOR OF OCD OUR
VISION AS IT RELATES TO THE
PROGRAM IS TO LEAD IN THE
DISCOVERY OF MECHANISMS,
TREATMENT AND CURES FOR DISEASES
OF THE DENTAL ORAL CANE OHIO
FACIAL.
-- COMPLEX.
*.
AND WE FOCUS ON THESE FOUR
AREAS.
IF YOU CAN GO TO THE NEXT SLIDE
PLEASE.
WHILE WE OFTEN TALK ABOUT
PATIENT CENTERED RESEARCH I'M
ONLY GOING TO TALK ABOUT IT
BRIEFLY.
WE WILL BE FOCUSING ON AGAIN THE
ACCELERATION OF DISCOVERY AND
THERAPIES.
WE USE THE SAME WORD
ACCELERATION IN OUR MISSION AND
THAT IS BECAUSE IN OUR VIEW
HAVING THE INFRASTRUCTURE IS
ABSOLUTELY NECESSARY AND THAT
INFRASTRUCTURE DOES INCLUDE HIGH
QUALITY RESEARCH NURSING
SUPPORT, ACTIVE PATIENT
RECRUITMENT, ENHANCED TECHNOLOGY
AND TRANSFER CAPABILITIES.
OUR ABILITY TO ADMINISTER
SUPPORT FOR REGULATED STUDIES
AND OUR COORDINATION WITH IRB.
AND HOW THE EXCELLENCE IN
CLINICAL CARE TIES
>>> THIS MISSION.
AND AS DR. DESOUZA HAS SAID OUR
RESEARCH SPECIFICALLY IN THE
INTERMURAL IS PATIENT STORIED
AND YOU CAN SEE THAT THESE ARE
THE AREAS OF CURRENT CLINICAL
RESEARCH.
AND IF YOU COULD GENTLY CAP --
THESE ARE THE INVESTIGATORS THAT
ARE INVOLVED IN THESE AREAS.
AND YOU CAN APPRECIATE THAT WE
HAVE BOTH CLINICIANS, CLINICAL
INVESTIGATORS.
WE HAVE BASIC SCIENTIST?
TRANSLATING THEIR WORK AND IT'S
A DEMONSTRATION THAT WE'RE NOW
MOVING THE ENTIRE SPECTRUM FROM
BENCH TO BEDSIDE.
I DO WANT TO POINT OUT ONE OTHER
GROUP AND THAT IS THE LIGHT RED
GROUP.
CLINICAL SCIENCE GROUP BECAUSE
THEY ARE EXPANDING OUR REACH BY
THEIR COLLABORATION WITH OTHER
INTERMURAL INVESTIGATORS AND
USING THINGS LIKE ORAL HEALTH
DETERMINANTS.
ONE GROUP, THE ALCOHOL USE
DISORDERS UNIT WILL BE WORKING
WITH OUR CLINICAL TEAM TO START
LOOKING AT SOCIAL DETERMINANTS
IN ORAL HEALTH DETERMINANTS AND
HOW THEY RELATE TO THE CONDITION
OF ALCOHOL ABUSE.
WE ARE ALSO GOING TO USE THAT
PLATFORM TO WORK CLOSELY WITH
RENEE AND THE DENTAL PUBLIC
HEALTH RESIDENCY AND FELLOWSHIP
TO INCORPORATE THEIR SKILL SETS
>>> THIS DEVELOPED PROTOCOL.
SO I WANTED TO SHOW YOU THE
PROTOCOL ACTIVITY OF THE
PROGRAM.
WE HAVE 17 PROTOCOLS.
50% ARE NATURAL HISTORY OR
OBSERVATIONAL STUDY AND 42% ARE
CLINICAL TRIALS.
17 IS IS NOT A LOT.
BUT I WANT YOU TO FOCUS ON THE
GREEN AND RED LINE BELOW AND
THAT IS BECAUSE THAT IS ACTUALLY
THE ACTIVITY.
OF ALL OF OUR CLINICAL TRIALS SO
YOU CAN IMAGINE WE OPEN AND
CLOSE MULTITUDE OF STUDIES
ALMOST EVERY TWO YEARS.
IS THAT IS MUCH HARDER THAN
FOLLOWING A NATURAL HISTORY
STUDY OVER 20 YEARS BECAUSE WE
NEED THE PERSONNEL TO STAND UP
TRIALS AND TO CLOSE TRIALS AND
THIS IS EXACTLY WHAT ANNA WILL
TALK ABOUT.
THROUGH A TIME LINE ALL OF THE
STEPS THAT WE HAVE TO GO THROUGH
AND WHY DID WE USE A TIME LINE?
WE USED THE LIFE CYCLE OF A
PROTOCOL AND FOR US IT'S WITHIN
A CONCEPT IS CONCEIVED TO THE
POINT WHERE A STUDY IS STARTED
AND INITIATED.
NOT THE PATIENT ENROLLMENT YET.
THIS WOULD LOOK AT OUR
OPERATIONS.
SPECIFICALLY THE OFFICE OF THE
CLINICAL DIRECTOR AND AS WELL AS
-- AND IF WE CAN DEMONSTRATE
THAT OCD AND -- TOGETHER ARE
IMPROVING THE TIME LINES THIS
WILL EXPLAIN WHY WE'RE ABLE TO
DO THIS MANY TRIALS OPEN AND
CLOSE IN SUCH A SHORT TIME.
SO WE OBVIOUSLY FOCUS ON OUR
METRICS BECAUSE AS AN OFFICE
THAT FOCUSES -- WE HAVE
CONSTITUENTS TO CONSIDER.
ONE OF THE METRICS IS HOW
QUICKLY CAN WE START THE STUDIES
AND THE AVERAGE TIME HAS BEEN
1.8 YEARS AND YOU THINK THAT IS
NOT THAT GREAT.
IT'S NOT.
BUT WE HAVE TO BE CLEAR AND
HONEST WITH WHAT WE'RE DOING.
WHEN WE TAKE AWAY IS THAT ONE
OUTLIER IT'S DOWN TO 1.4 YEARS
BUT WHEN WE START TO LOOK AT THE
BREAKDOWN.
YOU CAN SEE THOSE STUDIES IN
YELLOW ARE ACTUALLY OUR SIGNAL
HISTORY STUDIES.
THE OBSERVATION STUDIES SO WE
SNOW WE'RE QUITE EFFECTIVE IN
STARTING THE STUDIES AND YOU CAN
SEE THE FIRST STUDY IS OUR
COVID-19 STUDY WHICH WE STOOD UP
IN A MONTH.
FOUR WEEKS IN THE MIDDLE OF A
PANDEMIC AND THANKS ONLY BECAUSE
THE FOUNDATION THAT MICHELLE AND
JIM PUT DOWN FOR US WE WERE ABLE
TO BRING THESE PROCESSES AND
OPERATIONS TOGETHER TO STAND
THAT STUDY UP.
CAN WE THEN LOOK AT THE REST 6
OF OUR OPERATION.
THE PE HETEROGENEITY -- THEY ARE
FDA REGULATED.
WE USE SPONSORS IN SUPPORT FROM
PHARMA AND ONE OF THOSE TRIALS
DEMONSTRATED IS WITH BAYLOR
USING A U54 MECHANISM.
WE HAVE TO BE NIMBLE AND
PREPARED TO REACH ACROSS AISLES
SO THAT WE CAN EFFECTIVELY GET
OUR OPERATIONS TOGETHER AND
QUICKLY AND EFFICIENCY START
THESE STUDIES AND CLOSE THEM AS
WELL.
SO I DO WANT TO POINT THIS OUT.
AND AT THIS TIME WE ARE TAKING
LESSONS FROM THE COVID-19
EXPERIENCE.
ANNA WILL TELL YOU MORE ABOUT
THAT.
SHE IS GOING TO PRESENT THE
ACTUAL LIFE CYCLE AND HOW WE'VE
BEEN ABLE TO FOCUS OUR ATTENTION
ON AREAS OF OUR WEAKNESS.
>> THANKS.
SO I DO ALSO WANT TO THANK
COUNCIL AND DR. DESOUZA AND
DR. LEE THE OPPORTUNITY TO
CONTRIBUTE TO THIS TOPIC.
I WILL BE PROVIDING AN OVERVIEW
OF THE RESPONSIBILITIES WITHIN
THE NIDCR'S OFFICE OF CLINICAL
TRIALS OF OPERATIONS AND
MANAGEMENT ALSO REFERRED TO AT
OTOM AND SOME OF THE SPECIFIC
FUNCTIONS -- *.
THE MISSION OF OCTOM BEING TO
PROTECT THE RIGHTS AND WELFARE
OF NIDCR'S RESEARCH VOLUNTEERS.
AND THAT BEING THE DRIVING FORCE
OF RESPONSIBILITIES AND SINCE
ADVANCES OF HUMAN AND HEALTH
WELFARE AND ENSURING THE
PROTECTIONS ARE UPHELD IN THE
HIGHEST STANDARD TO THE HIGHEST
STANDARD WHICH PROMOTES THE
SCIENTIFIC RIGOR AND RESEARCH
ETHICS AND IN ORDER TO ACHIEVE
THIS MISSION AS JANICE WAS
MENTIONING WE RECOGNIZE THAT
OCTOM MUST WORK TOGETHER WITH
THOSE INVOLVED IN THE
DEVELOPMENT CONDUCT AND THOSE
WHO SERVE?
AN OVERSIGHT CAPACITY OF NIDCR
SUPPORTED CLINICAL RESEARCH.
SO WE'RE FOCUSING TODAY ON THE
INTERMURAL DIVISION BUT I WOULD
LIKE TO EMPHASIZE THAT OCTOM
RESIDES UNDER THE OFFICE OF THE
DIRECTOR AND PROVIDES SUPPORT TO
BOTH DIVISIONS AND THEIR
RESEARCH TEAMS IN SIMILAR
CAPACITIES.
SO YOU SEE HERE THAT OCTOM'S
MISSION IS ACHIEVED BY PROVIDING
OPERATIONAL AND MANAGEMENT AND
OVERSIGHT SUPPORT THROUGHOUT THE
LIFE CYCLE OF THE CLINICAL
RESEARCH.
OKAY TOMORROW.
--
AND SOME OF THE SUPPORT INCLUDES
ASSISTING STAFF AND THE
INVESTIGATIVE TEAM WITH
UNDERSTANDING POLICIES AND
EXPECTATIONS WITH HUMAN SUBJECTS
RESEARCH THAT ARE UNIQUE TO NIH
AS THEY EVOLVE AND AS MICHELLE
CULP MENTIONED NIH IS EMBARKING
AND CONTINUES TO EMBARK ON MANY
REFORMS AND POLICY AND AS
DR. DESOUZA AND DR. PEREZ-STABLE
MENTIONED EARLIER MANY
INITIATIVES.
SO ANOTHER CHARGE TO OCTOM IS
DEVELOPING RESEARCH TOOLS AND
TEMPLATES AND OTHER RESOURCES
SUCH AS PROCESS DOCUMENTS FOR
TRAINING AND REFERENCE AND MANY
OF THESE ARE ON THE PUBLIC
FACING WEBSITE AND REALLY ARE
DESIGNED TO PROMOTE CONSISTENCY
AND STANDARDIZATION OF BEST
PRACTICES.
ANOTHER RESPONSIBILITY IS
MANAGING THE CLINICAL RESEARCH
OPERATIONS AND MANAGEMENT
SUPPORT CONTRACT OTHERWISE
REFERRED TO AS CROM.
AND LASTLY MANAGING THE CLINICAL
RESEARCH SYSTEM THAT WAS
LAUNCHED EARLIER THIS YEAR.
AND I'LL PROVIDE A BRIEF
OVERVIEW OF ITS CAPABILITIES.
HERE IS THE TEAM.
WE HAVE A RELATIVELY SMALL STAFF
AND AS I MENTIONED WE WORK
ACROSS INTERMURAL AND EXTRAMURAL
DIVISIONS.
I SERVE AS THE DIRECTOR.
AND AGAIN THE FOCUS TODAY IS ON
OUR PARTNERSHIP WITH INTERMURAL
BUT I ALWAYS WANT TO HIGHLIGHT
THE FACT THAT WE DO CROSSCUT
ACROSS THE INSTITUTE IN SIMILAR
CAPACITY AND ARE TAILORED TO
EACH DIVISION'S NEEDS.
SO AS DR. LEE MENTIONED HERE IS
THE TIME LINE WHICH DEMONSTRATES
THE LIFE CYCLE OF A CLINICAL
STUDY.
MOSTLY CONCENTRATING ON THE
REVIEW AND APPROVALS INVOLVED
WITH LAUNCHING IS THE STUDY.
SO FROM STUDY CONCEPT SUBMISSION
TO INITIATION AND YOU CAN SEE
THE MULTIPLE LAYERS AN
INVESTIGATOR HAS TO UNDERGO JUST
TO GET STARTED.
CONCEPT REVIEW IF THERE ARE
PARTNERSHIPS OUTSIDE THE NIH
PUTTING TOGETHER CLINICAL TRIAL
AGREEMENTS.
THE EXTERNAL SCIENTIFIC REVIEW.
THERE IS DATA AND SAFETY
MONITORING REVIEW.
AND THE FDA AND THE IRB THOSE
ARE NOTED HERE AS CONTINUUM.
SOMETIMES ONE AFFECTS THE OTHER
SO THEY MIGHT HAVE TO GO THROUGH
MULTIPLE REVIEWS.
OF COURSE, GETTING IRB APPROVAL
NOT ANNIES EASE TASK FOR SOME
TRIALS AND STUDIES.
AND THIS IS REALLY PROBABLY
DOESN'T CATCH ALL OF THE REVIEWS
ESPECIALLY IF ONE IS UNDERTAKING
A GENE THERAPY OR STEM-CELL
STUDY.
BUT YOU SEE HERE IS THAT QUITE
INVOLVED.
AND SO -- I DID WANT TO
EMPHASIZE THAT WE HAVE AND ARE
MAKING MARKED IMPROVEMENTS IN
COMPARISON TO PRIOR YEARS AND
HAVE SHORTENED THAT WINDOW AND
IMPROVED IN EFFICIENCIES IN THAT
START UP PERIOD.
THESE IMPROVED EFFICIENCIES COME
FROM NOT ONLY IDENTIFYING
DEFICIENCIES AND IMPROVING OUR
PROCESSES AND MAKING SHIFTS IN
THE WAY THAT WE OPERATE BUT ALSO
HAVING A CHAMPION AT THE OCD
LEVEL AND AT THE OCTOM LEVEL WHO
WORK TOGETHER WITH THE
INVESTIGATIVE TEAMS TO HELP
SHEPHERD THESE PROCESSES AND
WORKFLOWS.
WHILE WE'VE EVALUATED EVERY STEP
AN NIDCR INVESTIGATOR MUST GO WE
WILL CONTINUE TO EVALUATE THEM,
EXTENUATING CIRCUMSTANCES SUCH
AS THE PANDEMIC AFFECT THEM IN
DIFFERENT WAYS SO THIS
COORDINATION BETWEEN OFFICES IS
CRITICAL.
I ALSO WANT TO EMPHASIZE THAT AS
WE LOOK TO THE FUTURE AND AS THE
INTERMURAL PORTFOLIO CHANGES AND
HAS CHANGED AND WILL CONTINUE TO
CHANGE WE'RE DOING THINGS AND
PUTTING THINGS IN PLACE TO MEET
THOSE CHANGES.
WE'RE LOOKING AT WAYS TO IMPROVE
INFRASTRUCTURE BECAUSE IT'S NOT
ENOUGH JUST TO GET A STUDY
STARTED.
BUT ONGOING MONITORING IS
CRITICAL TO ENSURE THE
SCIENTIFIC AND ETHICAL
INTEGRITY.
WE HAVE INFRASTRUCTURE IN PLACE
TO MONITOR THE QUALITY AND
SAFETY AND?
WE'RE LOOKING AT HOW DO WE
LEVERAGE OUR CURRENT
INFRASTRUCTURE TO INVEST IN
RECRUITMENT AND ENROLLMENT PLANS
EARLY AND TO MONITOR PROGRESS
AND ENSURE EFFICIENT TIMELY
RESEARCH WHILE BALANCING THIS
INTEGRITY AND QUALITY AND SO
WE'RE LOOKING AT THINGS THROUGH
A LENS OF SYSTEM BASED
INFRASTRUCTURE AND CAPABILITIES
MOVING FORWARD.
SO WHEN WE TALK ABOUT
INFRASTRUCTURE I DO WANT TO
HIGHLIGHT THAT PART OF THE
NIDCR'S INFRASTRUCTURE INCLUDES
THE CLINICAL RESEARCH OPERATIONS
AND MANAGEMENT SUPPORT CONTRACT.
REFERRED TO AS CROMS.
THE CLEARANCE WENT TO COUNCIL IN
MAY OF 2018.
8 THE KEY AREAS ARE LISTED HERE.
STUDY DOCUMENTATION SUPPORT.
DATA AND SAFETY MONITORING
SUPPORT OF THE CLINICAL SITE
MONITORING.
REGULATORY SUPPORT AND DATA
MANAGEMENT SERVICES AND KEY TO
THIS LAST ITERATION WAS THE
DEVELOPMENT AND MAINTENANCE OF
THE NIDCR CLINICAL RESEARCH
MANAGEMENT SYSTEM.
THE CROMS AND WHILE THERE ARE
MANY AREAS OF SUPPORT I WANTED
TO HIGHLIGHT TWO AREAS THAT
SPEAK TO THE FUTURE OF OUR
EFFICIENCY AND INFRASTRUCTURE
IMPROVEMENT.
SO TRAINING AND CLINICAL
RESEARCH MANAGEMENT SYSTEM.
SO HERE STARTING WITH THE CRMS
-- I'LL HIGHLIGHT THE SYSTEM
CAPABILITIES, THE SYSTEM
LAUNCHED IN FEBRUARY OF 2021.
IT PROVIDES AN NIDCR ENTERPRISE
SYSTEM WITH SEVERAL MODULES TO
TRACK THE MONITORING OF THE
NIDCR CLINICAL RESEARCH.
SO IN BRIEF IT TRACKS OUR HUMAN
SUBJECTS RESEARCH AT THE GRANT
LEVEL AND STUDY LEVEL STORING
STUDY ATTRIBUTES AND DOCUMENTS
AND MANAGING THE NIDCR OVERSIGHT
ASSESSMENT FLOW.
IT PROVIDES A TRACKING SYSTEM
FOR OUR SAFETY OVERSIGHT
COMMITTEES INCLUDING MANAGING
THE NUMBER OF CONFLICT OF
INTEREST FLOW AND PROVIDING A
SECURE PLATFORM FOR MEETINGS AND
REPORTS AND COMMITTEES.
IT PROVIDES A REPOSITORY FOR
SAFETY EVENT AND MANAGES THE
SAFETY EVENT FLOW AND SUPPORTS
NIDCR ADMINISTRATIVE FUNCTIONS
TO HELP US MANAGE OUR WORKFLOW.
SO WHEN WE TALK ABOUT A CONSTANT
EVOLVING -- IN THE CLINICAL
RESEARCH ENVIRONMENT AND PUTTING
THINGS IN PLACE TO MEET THE
NEEDS AND CHALLENGES AND LOOKING
AT WAYS TO IMPROVE
INFRASTRUCTURE WHAT ARE THESE
OPPORTUNITIES IN FRONT OF US?
WE HAVE THE ELECTRONIC SYSTEM
THROUGH THE NIDCR -- AND WANT TO
LEVERAGE THESE CAPABILITIES.
AND WORK WITH INVESTIGATIVE
TEAMS AND OVERSIGHT BODIES TO
MONITOR PROGRESS AND ADAPT
STRATEGIES TO HAVE THE SAME
SUCCESS IN CARRYING OUT THE
STUDIES AS WE'VE HAD IN
LAUNCHING THE STUDIES.
SO THROUGHOUT THE LIFE CYCLE.
CLINICAL STUDY.
WHAT CAN WE OFFER IN THE FORM OF
EDUCATION AND TRAINING TO BETTER
PREPARE TEAMS FOR CLINICAL TRIAL
MANAGEMENT?
ARE THERE UNIQUE ASPECT FROM THE
COMMUNITIES RELATED TO CLINICAL
RESEARCH THAT COULD BE
INCORPORATED INTO SUCH TRAINING.
WE'VE HEARD A LITTLE BIT ABOUT
THAT TODAY.
WE'RE HAVING THOSE CONVERSATIONS
AND THESE CONVERSATIONS ARE
PARTICULARLY IMPORTANT FOR THE
NEXT GENERATION OF
INVESTIGATORS.
ANOTHER IMPORTANT ASPECT OF OUR
FEATURE DIRECTION IS THE
OPPORTUNITIES THE PANDEMIC HAS
PRESENTED AND WE'VE ALSO HEARD
THAT THERE ARE MANY FROM A
QUALITY AND SCIENTIFIC INTEGRITY
PERSPECTIVE ADAPTING TO --
REMOTE AND ENSURING MAINTAINING
PROPER OVERSIGHT AND
COMMUNICATION WHICH CAN BE VERY
CHALLENGING AND THESE LESSONS
CONTINUE TO SHAPE OUR OVERSIGHT
ACTIVITIES AND HOW CAN WE BE
PREPARED TO MORE SWIFTLY
ADAPTED TO LAUNCHING AND
CARRYING OUT OUR STUDIES UNDER
EXTENUATING CIRCUMSTANCES.
WE CONTINUE TO LEARN FROM THESE
EXPERIENCES.
SO AS WE LOOK TO THE FUTURE AND
IN THINKING ABOUT THE NIDCR'S
STRATEGIC PLAN AS DR. LEE
MENTIONED EARLIER I WANTED TO
HIGHLIGHT ITS GUIDING
PRINCIPLES.
SO HERE THOSE CORE VALUES THAT
GROUND OUR THINKING AND GUIDE
OUR DECISIONS ACROSS ALL ASPECTS
OF THE NIDCR RESEARCH ENDEAVOUR
-- SCIENTIFIC EXCELLENCE AND
INTEGRITY AND ENSURING ALL
RESEARCH IS CONDUCTED ETHICALLY
AND THE DATA IS WELL DESCRIBED
FOR REPLICATION FOR APPLICATION.
STRENGTHENING OUR EFFORTS TO
INCREASE DIVERSITY AND EQUITY
AND INCLUSION IS VERY IMPORTANT.
AND MAINTAINING OUR COMMITMENT
TO BE PROPER STEWARDS OF OUR
RESOURCES.
AND LASTLY OUR COMMITMENT TO
EMBRACE AND MANAGE CHANGE TO BE
PROACTIVE AND NIMBLE IN OUR
RESPONSES.
AND I THINK WE CAN OVERLAY AND
ALIGN MUCH OF WHAT WE'RE
DISCUSSING TODAY WITH OUR CORE
VALUES AND THE PARTNERSHIPS THAT
WE HAVE.
WE CONTINUE TO SHAPE -- THESE
CORE VALUES AND THESE
PARTNERSHIPS BEYOND OUR
INSTITUTE IMPORTANT TO THESE
ENDEAVORS.
>> THANKS, ANNA.
THE ONE THING THAT I WANT TO
POINT OUT IS THE FACT THAT THIS
INTENTIONAL SEPARATION BETWEEN
OCTOM AND OCD WAS BRILLIANT.
AND I SAY IS THAT BECAUSE IT
ALLOWS US TO NAVIGATE SUPPORT
BUT WE HAVE A GROUP THAT HELPS
OVERSEE AND MONITOR WITHOUT THE
PERCEIVED CONFLICT.
SO THIS IS REALLY IMPORTANT AND
ANNA GRAPPLED THROUGH THIS ISSUE
TO TO BE SURE IS THAT WE'RE
NEVER COMPROMISING.
JUST TO CONTINUE I WANT TO ALSO
POINT OUT THAT TO BE ABLE TO DO
THE EFFECTIVE RESEARCH THAT
WE'RE CURRENTLY EMBARKING ON WE
HAVE TO HAVE STRONG PARTNERSHIPS
AND I'M POINTING OUT THE
PARTNERSHIPS THAT INCLUDE THE
PHARMACEUTICAL AS WELL AS THE
INTERMURAL AND EXTRAMURAL
PARTNERSHIPS THAT WE HAVE.
WE HAVE A MOU BECAUSE THIS
ISth MOST COST EFFICIENT WAY
TO RUN OUR BUSINESS.
WE ALSO HAVE THE FIRST PROGRAM
LETTER OF AGREEMENT WITH HOWARD
UNIVERSITY SCHOOL OF DENTISTRY.
THIS IS THE FIRST WE'VE HAD THIS
AND TRULY EXCITING AND WHEN WE
TALK ABOUT WHEN WE MOVE AT THE
SPEED OF TRUST THIS IS ONE OF
THE FIRST STEPS IN MOVING
>>> OUR COMMUNITY AND
COMMUNITY-BASED TRIALS.
WE HAVE A MULTITUDE OF MTAs.
AND DATA SHARING AGREEMENTS.
BUT I WANT TO POINT OUT ONE
OTHER THING THAT WE DO AS A
SMALL INSTITUTE SOMETHING THAT
IS YOU SNEAK AND WE HAVE 12 --
CLINICAL TRIAL AGREEMENTS.
WE ARE ACTUALLY DOING AN AMAZING
JOB PARTNERING WITH OUR PRIVATE
INDUSTRY FOLKS.
AND YOU CAN SEE A COUPLE OF
THOSE LISTED HERE.
THIS IS OBVIOUSLY THE EFFORTS OF
THE INVESTIGATORS BECAUSE THIS
IS ALL INVESTIGATOR INITIATED
RESEARCH.
I ALSO WANT TO POINT OUT BASED
ON THOSE STRONG DISCUSSIONS
WE'RE ANTICIPATING ANOTHER FOUR
CLINICAL TRIALS TO INITIATE OVER
THE NEXT ONE TO TWO YEARS.
AN EXAMPLE OF LAYING THE
FOUNDATION SO THAT WE CAN OPEN
AND CLOSE TRIALS EFFICIENT --
EFFICIENTLY.
THE BENCH TO BEDSIDE AND BACK
INITIATIVES ARE WAYS FOR THE
EXTRAMURAL COMMUNITY TO WORK
WITH INTERMURAL INVESTIGATORS
AND I'M PLEASED TO DEMONSTRATE
THAT WE'VE STARTED THE FIRST ONE
FOR THE NIDCR.
DR. YOE WILL BE UTILIZING THE
RESOURCES TO STUDY TMJ
DEVELOPMENT.
WE ALSO HAVE A U54 WITH
DR. BRENDAN LEE.
STUDYING -- THE EFFECTIVENESS OF
ENVISION LINE.
*.
WE GOT US?
THAT DR. COLLINS WARN ERAS WELL
AS PARTNERS IN NICHD WILL BE
EMBARKING ON AN AWARD LOOKING AT
BONE PRESERVATION IN CHILDREN
WITH SJORGEN'S SYNDROME.
*.
HOWARD UNIVERSITY IS THE MOST
RECENT PARTNER AND WE CONTINUE
TO TAP INTO OUR COMMUNITY.
BUT WE CAN DO MORE.
THIS SLIDE REMINDS ME TO SHARE
THAT ALL OF THIS HAPPENS AT THE
CLINICAL CENTER.
AMERICA'S RESEARCH HOSPITAL.
A 200 BED HOSPITAL WITH 82 DAY
HOSPITAL UNITS WHICH INCLUDES
THE DENTAL CLINIC.
ALL PATIENTS ARE SUBJECTS OF A
PROTOCOL.
AND SERVICES ARE FOR FREE.
YOU CAN SEE THE BREAKDOWN --
OVER 1500 -- THEY ARE SIMILAR.
WE ARE REFLECTING IS THAT OUR
CLINICAL TRIAL NUMBERS HAS GROWN
OVER THE COURSE OF THE LAST FEW
YEARS.
THE UNIQUENESS IS THAT WE FOCUS
ON RARE AND UNDIAGNOSED DISEASES
SO WE DON'T NECESSARILY COMPETE
WITH OUR EXTRAMURAL COLLEAGUES.
WE ALSO HAVE OUTSTANDING
CAPABILITIES FOR DEEP
PHENOTYPING THAT YOU CANNOT GET
ANYWHERE ELSE IN THE MOST COST
EFFECTIVE WAY.
NOW THE DENTAL CLINIC IS NESTED
IN THE CLINICAL CENTER AND IS IN
WHERE WE ASK OUR HOSPITAL
DENTISTS TO THINK ABOUT
THEMSELVES IN THE BIGGER BROADER
COMMUNITY.
THE MISSION IS TO PROVIDE
CLINICAL CARE AS WELL AS
CONSULTS FOR ALL OF THE NIDCR
SUBJECTS AND PATIENTS.
BUT THEY ALSO SUPPORT THE
CLINICAL RESEARCH AND OUR
DENTIST ARE DOING A PHENOMENAL
JOB REACHING OUT TO OTHER
COLLABORATORS.
THAT PHOTO INCLUDES ALL OF OUR
RESEARCH NURSES AND THEY ARE
TRULY THE BACKBONE OF WHY WE CAN
DO SUCH EFFECTIVE AND RIGOROUS
WORK.
THINK THEY THERE IS AN ARMY.
THIS IS OUR ARMY.
I JUST WANTED TO MAKE SURE THAT
THEY ARE RECOGNIZED IN THE
ENDEAVORS OF THE INTERMURAL
PROGRAM.
I ALSO WANT TO POINT OUT THAT
OUR HOSPITAL DENTIST ARE THE
CONNECTION BETWEEN A NUMBER OF
OUR MEDICALLY BASED PROTOCOLS TO
THE ORAL HEALTH AND MARIE HAS
BEEN WITH US SINCE 2018 AND SHE
IS OUR CHIEF OF DENTAL CLINICAL
OPERATIONS.
I'M PLEASED TO ANNOUNCE THAT
WE'VE HIRED TWO NEW STAFF
CLINICIANS.
WE HIRED HER KNOWING THAT WE'RE
EXPANDING THE AREA OF EARLY
CHILDHOOD DEVELOPMENT AS WELL AS
ORAL HEALTH AND DR. KHAVANDG AR.
SPENDING TIME IN THE DENTAL
INCLUDE ANYBODY AS HER NEW
DENTAL PATIENT SAFETY OFFICER
AND LIAISON.
THEY OVERSEE THE STAFF HERE ON
THE LEFT AND IT INCLUDES A
NUMBER OF PART-TIME
PRACTITIONERS WHO HAVE
MAINTAINED A QUALITY OF CARE FOR
US AS WELL AS OUR DENTAL SUPPORT
STAFF.
THESE ARE JUST SOME OF THE
THINGS THAT OUR DENTAL CLINIC
STAFF DO.
IT REFLECTS OUR RESEARCH AREAS.
AND IN THIS SETTING WE, ONE OF
OUR MISSIONS IS TO TRAIN THE
NEXT GENERATION.
BECAUSE OF SUCH A STRONG SUPPORT
NETWORK I THINK WE HAVE A VERY
STRONG CLINICAL RESEARCH
FELLOWSHIP PROGRAM THAT HAS
GROWN AND HAS IMPROVED AND THAT
IS BECAUSE THE ENVIRONMENT HAS
NOW BECOME AN ENVIRONMENT THAT
IS SUPPORTIVE FOR CLINICAL
RESEARCH.
THIS PROGRAM WAS ESTABLISHED IN
2010 BY JIM MELVIN AND IT'S
UNIQUE BECAUSE WE OFFER MENTORED
RESEARCH TRAINING TO IMPROVE
ORAL HEALTH AND THIS IS BY
ENSURING THAT WE HAVE WELL
PREPARED INVESTIGATORS AND
FACULTY AND WE DO THIS BY
CUSTOMIZING THEIR CAREER
DEVELOPMENT.
WE DON'T ACCEPT MORE THAN THREE
A YEAR.
WE'RE ABLE TO FOCUS ON THE
GROWTH AND DEVELOPMENT OF THE
YOUNG INDIVIDUALS.
75% OF THE TIME THEY ARE DOING
RESEARCH BUT THEY DEDICATE DOING
THEIR OWN RESEARCH OR WORKING
WITH THEIR INVESTIGATOR AND WE
ENCOURAGE GRANT WRITING.
WHEN JIM RETIRED HE HANDED THE
BATON TO ME BUT I'VE ANDED THE
BATON TO DR. JACKIE WHO IS A
FELLOW.
OUR FELLOWSHIP PROGRAM REQUIRES
THAT YOU HAVE A DENTAL DEGREE.
RESEARCH EXPERIENCE IS
PREFERRED.
U.S. CITIZENSHIP IS NOT REQUIRED
BUT YOU HAVE TO BE PREPARED TO
BE VERY DENSE,ED AT THE CLINICAL
* CENTER.
AT A TWO TO THREE-YEAR RESEARCH
TRAINING EXPERIENCE.
YOU'RE FULLY IMMERSED.
EVERY TRAINEE IS EXPECTED TO
HAVE A RESEARCH PROTOCOL WITH A
PI AND THEN WE HAVE THE PERKS
AND BENEFITS OF GREAT HEALTH
INSURANCE AND SALARY IS THAT IS
COMMENSURATE WITH THE
EXPERIENCE.
I'M PLEASED TO SHOW YOU THAT
THAT PHOTO IS DR. -- FROM BRINK
AMISTAR STAR AND THAT IS FROM
2014 AND WE WERE DOING
TELECONFERENCING.
WE WERE AHEAD OF THE CURVE AND
NICE TO SEE THAT BECAUSE ONE OF
THE PURPOSES OF OCD AND OCTOM IS
TO ALWAYS STAY AHEAD.
OUR CURRICULUM IS CENTERED
AROUND A WEEKLY CLINICAL CASE
CONFERENCE.
INVITES BOTH INTERMURAL AND
EXTRAMURAL SPEAKERS.
WE'VE HAD RECENT WOMEN IN
SCIENCE SERIES WHICH HAS INVITED
INTERNATIONAL SPEAKERS.
WE'RE USING THIS PLATFORM TO
MAKE SURE OUR FELLOWS CAN
NETWORK AND THEY TOO ARE GIVEN
OPPORTUNITIES TO SPEAK WITH
THESE WORLD-CLASS LEADERS.
IN PREPARING THE FUTURE WE HAVE
TO LOOK AT OUR METRICS.
WE HAVE SEND 24 FELLOWS
>>> THE PROGRAM SINCE 2010 AND
THE GENDER SPLIT IS EQUAL AT
THIS TIME I'M HAPPY TO SAY.
YOU CAN SEE THE RACE AND ETHNIC
BREAK DOWN.
WE'VE BEEN TRACKING WHERE THESE
FELLOWS END UP.
AND YOU CAN SEE THAT OF THE 16
WHO COMPLETED THIS PROGRAM OR
WERE TRANSFERRED OUT AND I SAY
TRANSFERRED BECAUSE I'M HAPPY TO
SAY WITH THE MIXED EMOTIONS THAT
OUR FELLOWS ARE GETTING CHERRY
PICKED AND SOME OF THEM LEAVE
BEFORE THE YEARS.
WE HAVE HAD TWO GO ON TO PRIVATE
PRACTICE.
WE HAVE 8 IN FACULTY POSITIONS
THROUGHOUT THE COUNTRY.
WE HAVE ONE AT THE FDA.
ONE AT CMS.
THE FIRST CHIEF DENTAL OFFICER
FOR CMS.
WE HAVE TWO STAFF SCIENTIST AT
THE NIDCR AND TWO ACI OR TENURED
TRACKED ALSO AT THE NIDCR.
IT'S A COMPETITIVE PROCESS AND
YOU CAN SEE SEAN ABRAMS IS OUR
NEWEST FELLOW.
HE JOINED US IN 2021 AND YOU CAN
SEE OUR FEARLESS LEADER ON THE
LEFT.
DOING WHAT SHE LOVES THE MOST
AND IN ACT GIVING A -- SEMINAR.
SO I JUST WANT TO CONCLUDE WITH
SOME OF THE AREAS THAT ANN AND I
ARE LOOKING TOWARDS *.
WE ARE THINKING ABOUT OR I HAVE
STARTED TO -- CHANGING THE MODEL
OF BUSINESS.
AS THINGS EVOLVE WE CERTAINLY
HAVE TO.
TO BE MORE INVOLVED IN THE
STRATEGIC PLANNING.
NOT JUST RECIPIENTS OF SUPPORT
AND IS NOT JUST TO PROVIDE --
BUT BE PART OF THE PLANNING
BECAUSE WE NOW HAVE VETERAN
INVESTIGATORS WHO CAN TELL YOU
MORE ABOUT RESEARCH PROTOCOL
DEVELOPMENT AND CLINICAL TRIALS
DEVELOPMENT BETTER THAN MOST OF
US IN MY OFFICE AND SO I'M GOING
TO BE UTILIZING THAT EXPERTISE
EVEN MORE AGGRESSIVELY IN THE
NEXT FIVE YEARS.
WE HAVE TO BE NICKEL AND WE'VE
HEARD THE TERM PIVOT AND BEING
NIMBLE AND IT IS TRUE.
WE CAN TRACK AND DO OUR
ANALYTICS AND SEE WHERE OUR
POINTS OF WEEKNESS ARE AND THE
ROADBLOCKS ARE.
WE WANT TO TO MAKE SURE WE HAVE
A STRONG PARTNERSHIP.
WE HAVE 12 AGREEMENTS WITH
DIFFERENT GROUPS AND COMPANIES.
AND SO WE HAVE TO MAINTAIN THIS.
BECAUSE WE'RE EXPANDING WITHOUT
BREAKING OUR BUDGET.
WE ALSO ARE TAKING A PAGE FROM
THE PBRN AND THE NIMHD PLAYBOOK.
BECAUSE WE WANT TO DEVELOP THAT
LEVEL OF TRUST WHERE WE CAN NOW
HAVE STUDIES GOING OUT INTO THE
COMMUNITY.
WE'RE ALSO EXAMINING OUR METRICS
AND WE TALK ABOUT THIS
REGULARLY.
BUT ONE AREA THAT I HOPE TO
EXPAND IS THE CO-ORDER NATION
BEYOND MY OFFICE TO IMPROVE THE
EFFICIENCIES OF PROCESSES.
WE'RE GOING TO LOOK AT HIRING
PROCESSES TO BE SURE THAT WE CAN
RESPOND WHEN OUR CONTRACTS ARE
IN PLACE AND WE NEED PERSONNEL
BECAUSE THEY TOO ARE THE
BACKBONE OF US BEING ABLE TO DO
THIS QUICKLY.
WE'RE ASKING OUR INVESTIGATORS
TO START LOOKING AT THEIR
SUBJECT ENROLLMENT AND IMPROVE
THE DIVERSITY.
AND WE ARE TRAINING THE NEXT
GENERATION AND WE WOULD LIKE TO
INCORPORATE TRAINING MODELS THAT
INCLUDE CLINICAL RESEARCH
IMPLEMENTATION.
AS YOU JUST SAW BRIEFLY THAT
CLINICAL TRIAL MANAGEMENT IS A
SKILL SET THAT I THINK NOT EVERY
PROGRAM IN THE COUNTRY PROVIDES.
AND WE'RE FORTUNATE BECAUSE I
CAN SNAKE THREE SPECIFIC
FELLOWS.
THEY'VE BEEN INTIMATELY INVOLVED
AND I THINK THAT LESSON IS WHAT
THEY ARE GOING TO TAKE TO THEIR
UNIVERSITIES SO WE'RE LUCKY AND
PLEASED AND I LEAVE YOU WITH
THIS QUOTE.
WE NORMALLY TALK ABOUT SCIENCE
BUT TODAY WE THOUGHT WE WOULD
TELL YOU ABOUT IMPLEMENTATION
BECAUSE WE REALLY NEED ALL OF
THIS INFRASTRUCTURE IN PLACE TO
GET US TO GET DR. SOUZA'S VISION
IN PLACE.
WE CAN TEACH A MAN OR WOMAN TO
FISH BUT IT WILL ONLY FEED THEM
FOR A DAY.
BUT IF YOU GIVE -- SORRY.
IF YOU GIVE A MAN OR WOMEN A
FISH THEY WILL ONLY EAT FOR A
DAY.
BUT IF YOU TEACH A MAN OR WOMAN
TO FISH THEY WILL FEED THEIR
INSTITUTE.
>> THAT WAS TRULY WONDERFUL.
THANK YOU.
IT'S SO PARALLELS THE RFAs
THAT COUNCIL HAS APPROVED OF
CREATING A PHILOSOPHY OF
PRACTICE BASED RESEARCH
PHILOSOPHY WITHIN DENTAL SCHOOLS
THAT WILL HELP BREED THIS NEW
GENERATION OF CLINICAL SCHOLARS.
AND OFFER CONTINUE TO CONTRIBUTE
TO THE GROWTH OF THE PROFESSION
AND THE PROGRESS IS REMARKABLE.
I THANK YOU FOR ALL OF THE WORK
THAT YOU DO.
AND I KNOW THERE WILL BE LOTS OF
CONNECTIONS COMING FORTH I HOPE
FROM AFTER COUNCIL THAT WE CAN
STRENGTHEN.
THANK YOU FOR THE EFFORT AND
SINCE YOU TALKED ABOUT FISH IT
IS CLOSE TO LUNCHTIME AND WE DO
NEED TO TAKE A BREAK.
I'LL PASS THIS ON TO LYNN WHO
WILL TELL US ABOUT THE NEXT ITEM
OF BUSINESS
>> WE HAVE SAY MINUTE BREAK
SCHEDULED SO WE'LL RECONVENE AT
1:10.
>> WE GO INTO CLOSED SESSION.
>> IS NOT.
THE CONCEPTS.
>> THANK YOU.
WE'LL TAKE A BREAK AND BE BACK
IN 15 MINUTES.
>>I AM GOING TO JUMP IN WITH
THE NEXT AGENDA ITEM.
I HAVE TO MAYBE TAKE ONE SECOND
TO SPEAK TO THE FACT THAT THIS
IS REALLY AN ENERGIZING MORNING.
THANKS TO ALL OF THOSE SPEAKERS.
AND WITH THAT I WISH YOU A GOOD
AFTERNOON AND I'M TODAY GOING TO
ACTUALLY MAYBE I'LL INTRODUCE
MYSELF AND MENTION THAT I'M THE
DIRECTOR FOR NIDCR FOR CLINICAL
RESEARCH AND TODAY I'M
PRESENTING THE 2022 ADVISORY
COUNCIL REPORT ON COMPLIANCE
WITH THE NIH INCLUSION COMBINE
LINES.
SO THIS IS A SUMMARY OF THE
ACCOMPANYING TRIENNIAL INCLUSION
REPORT THAT YOU SHOULD HAVE WITH
YOUR COUNCIL MATERIALS AND
ULTIMATELY WE'RE SEEKING COUNCIL
CERTIFICATION OF NIDCR'S
INCLUSION DATA FOR THE FISCAL
YEARS 2019-2021.
SO NEXT SLIDE PLEASE.
I'D LIKE TO START BY OFFERING A
BACKGROUND ABOUT THE INCLUSION
REPORTING REQUIREMENTS THAT ARE
IN PLACE.
AND THIS ALL BEGAN IN 1993 WITH
THE NIH REVITALIZATION ACT WHICH
REQUIRES THAT NIH ESTABLISH
GUIDELINES FOR THE INCLUSION OF
WOMEN IN MINORITIES AND NIH
FUNDED CLINICAL RESEARCH.
THIS CONTINUED WITH THE 21st
CENTURY CURES ACT DECEMBER 2016
AND THE 21st CENTURY CURES
ACT THERE WERE A NUMBER OF
ELEMENTS TO IT.
FROM AN INCLUSION REPORTING
PERSPECTIVE IT REQUIRES THAT
PHASE III CLINICAL TRIALS
SUPPORTED BY NIH REPORT THE
RESULTS OF ANALYSIS BY SEX AND
GENDER AND/OR RACE AND ETHNICITY
TO CLINICAL TRIALS.--.GOV.
THEN ANOTHER ELEMENT OF THIS ACT
WAS CONSIDERATION OF INDIVIDUALS
OF ALL AGES IN NIH FUNDED
CLINICAL RESEARCH AND REQUIRES
THE REPORTING OF PARTICIPANT AGE
AND ENROLLMENT IN THE PROGRESS
REPORTS.
AND THIS ASPECT OF THE
REQUIREMENT CAME INTO PLACE FOR
APPLICATIONS SUBMITTED ON OR
AFTER JANUARY 25, 2019 SO THOSE
OF YOU WHO ARE CONDUCTING
CLINICAL RESEARCH FOR WHICH
INCLUSION REPORTING IS REQUIRED
MAY BE SEEING THIS COME ABOUT
WITH YOUR ANNUAL PROGRESS AND
REPORTS.
SO A LITTLE BIT OF INFORMATION
ABOUT REPORTING.
ANOTHER PIECE OF THE 21st
CENTURY CURES ACT IS THAT THE --
IT AMENDED THE REPORTING
REQUIREMENT TO ADVISORY COUNCILS
FROM BIANNUAL TO TRY ANIAL.
-- TRI-ANIAL.
I'M GOING TO OFFER A SUMMARY.
I WILL MENTION WHERE THIS DATA
COMES FROM IS THESE ARE
INCLUSION DATA THAT ARE REPORTED
BY GRANTEES TO NIH IN ANNUAL
PROGRESS REPORTS AND FINAL
PROGRESS REPORTS.
AND SO I'M GOING TO START WITH
SPEAKING ABOUT ENROLLED STUDY
PARTICIPANTS.
THIS PERTAINS TO TABLES 2, 3 AND
4 IN THE ACCOMPANYING REPORT AND
THIS EXTRAMURAL AND INTERMURAL
NIH DEFINED CLINICAL RESEARCH.
FIRST I WOULD LIKE TO MENTION
THAT THE NUMBER OF STUDIES
CONTRIBUTING TO ENROLLMENT DATA
HAVE INCREASED OVER THE
REPORTING TIME FRAME FROM ABOUT
123 IN 2019 UP TO 141 IN 2021
AND WHILE THE NUMBER OF STUDIES
CONTRIBUTING DATA HAS INCREASED
WE CAN SEE IS THAT THE NUMBER OF
STUDY PARTICIPANTS HAS DECREASED
WITH OVER 27,000 IN 2019.
OF COURSE QUITE A SIGNIFICANT
DIP IN 2020 IN THE EARLY DAYS
AND MAYBE THE HEART OF THE
PANDEMIC.
AND SOME RECOVERY IN 2021 BUT IS
NOT UP TO PREPANDEMIC ENROLLMENT
NUMBERS.
SO I THINK BASED UPON THESE
NUMBERS WE CAN SPECULATE IS THAT
THE COVID PANDEMIC HAS AFFECTED
ENROLLMENT IN NIDCR FUNDED
CLINICAL RESEARCH STUDIES.
SO THIS TABLE REPRESENTS
ENROLLED STUDY PARTICIPANTS.
THE TOP PORTION IS BY SEX AND
GENDER.
OF COURSE, THIS IS EXTRAMURAL
AND INTERMURAL NIH DEFINED
CLINICAL RESEARCH.
FEMALE PARTICIPATION HAS
REMAINED STABLE.
AND THE BOTTOM HALF OF THE TABLE
IS ETHNICITY DATA AND WE CAN SEE
THAT THOSE SELF-REPORTING AS
BEING HISPANIC OR LATINO
ETHNICITY HAS DECREASED
SOMEWHAT.
AND I WOULD ALSO LIKE TO POINT
OUT THAT THOSE WITH UNKNOWN OR
NOT REPORTED ETHNICITY DOES
COMPRISE A PORTION OF ENROLLED
STUDY PARTICIPANTS.
THIS IS BY RACE FOR ALL NIH
DEFINED CLINICAL RESEARCH AND A
FEW TRENDS IS THAT PARTICIPATION
OF WHITE INDIVIDUALS HAS
REMAINED RELATIVELY STABLE OVER
THIS REPORTING PERIOD AT ABOUT
50%.
THOSE WHO REPORT AS BEING BLACK
OR AFRICAN-AMERICAN HAS
DECREASED SLIGHTLY OVER THAT
REPORTING TIME FRAME.
WE COULD PERHAPS SAY THAT
AMERICAN INDIAN AND ALASKAN
NATIVE PARTICIPANTS HAS SLIGHTLY
INCREASED.
AND ONE INTERESTING FEATURE IS
THOSE WHO SELF-REPORT AS BEING
OF MORE THAN ONE RACE TOOK A
SIGNIFICANT AND INTERESTING DIP
IN 2020 DURING THE HEIGHT OF THE
PANDEMIC BUT APPEARS TO HAVE
INCREASED IN 2021.
AND OF COURSE I WILL MENTION
THAT AS OCCURRED WITH THE
ETHNICITY DATA THOSE WITH AN
UNKNOWN OR NOT REPORTED RACE
DOES COMPRISE A PORTION OF THE
ENROLLED STUDY PARTICIPANTS.
THIS IS NIDCR SUPPORTED PHASE
III CLINICAL TRIALS.
AND THIS ALIGNS WITH TABLES 5, 6
AND 7 IN YOUR TRIENNIAL REPORT.
SO I THINK FIRST IT'S HELPFUL TO
MENTION THAT GRANTEES OR
AWARDEES SELF-REPORT WHETHER OR
NOT THEIR TRIAL MEETS THE PHASE
III DEFINITION AND TO POINT OUT
THAT NIH'S PHASE III DEFINITION
IS AN INTERVENTION THAT IS
ADMINISTERED TO LARGE GROUPS OF
PEOPLE BELIEVED TO BE AT LEAST A
THOUSAND TO A FEW THOUSAND AND
COMPARED WITH THOSE WHO DO NOT
RECEIVE THE INTERVENTION WITHOUT
EFFECTIVENESS AND SAFETY AND
SIDE EFFECTS.
SO OVER THE COURSE OF THIS
REPORTING PERIOD NIDCR HAS
SUPPORTED SEVEN TO 8 PHASE III
TRIALS.
AND WHILE THE NUMBER OF TRIALS
HAS REMAINED RELATIVELY
CONSISTENT THERE IS SOMEWHAT OF
A DECREASE IN PARTICIPANT
ENROLLMENT.
I REALIZE THE NUMBERS ARE
SMALLER BUT IF WE THROUGH ABOUT
THE NUMBER OF TRIALS BEING
SUPPORTED THERE IS A DECREASE IN
ENROLLMENT
>>> PHASE III TRIALS OVER THIS *
REPORTING TIME FRAME.
*.
7 OR 8 PHASE III TRIALS IS QUITE
SIGNIFICANT.
THESE ARE LARGE TRIALS AND I
JUST WANT TO MENTION THAT THEY
ARE ON A NUMBER OF VARIETY OF
TOPIC AREAS.
INCLUDING DENTAL CARRY
PREVENTION.
*.
TREATMENT AND ACUTE POST
SURGICAL PAIN MANAGEMENT.
TOBACCO SESSION SAYS AND
REDUCTION IN DENTAL ANXIETY.
A NUMBER OF TOPICS.
SO FOR PHASE III TRIAL
ENROLLMENT THE TOP PORTION OF
THE TABLE THIS IS SEX, GENDER
ENROLLMENT AND WE CAN SEE OUR
FEMALE ENROLLMENT HAS REMAINED
STABLE.
ACTUALLY HAS INCREASED
REPRESENTING 65-69% OF ENROLLED
PARTICIPANTS.
THIS HAS BEEN A TREND OVER MANY
YEARS THAT THERE HAS BEEN A
GREAT A GREATER RATE OF FEMALE
ENROLLMENT FOR PHASE III TRIALS.
AND MOST LIKELY DUE TO THE FACT
THAT A GOOD NUMBER OF OUR PHASE
III TRIALS ADDRESS ORAL HEALTH
DISPARITIES AND WHEN WE THINK OF
ORAL HEALTH DISPARITIES WE MIGHT
ENROLL YOUNG CHILDREN IN PHASE
III TRIALS AND MANY TIMES IT'S
CARE GIVER CHILD DIE ADDS * THAT
ARE ENROLLED AND MANY TIMES THE
CAREGIVERS ARE FEMALE.
SO IS THAT IS A TREND THAT WE'VE
SEEN OVER THE MANY YEARS.
LOOKING AT THE BOTTOM PORTION OF
THE TABLE WITH OUR ETHNICITY
DATA THERE IS AN INCREASING
TREND OF HISPANIC LATINO
ETHNICITY.
AND ALSO NOTABLE DECREASE IN
THOSE REPORTING UNKNOWN OR NOT
REPORTED ETHNICITY OVER THE
STUDY TIME FRAME.
AND I WILL SPECULATE THAT THAT
DECREASE WE'RE SEEING IS REALLY
SOME NIH WIDE EFFORTS TO TRY TO
OBTAIN ETHNICITY DATA IN
ADDITION TO HISTORICALLY RACE
DATA HAD BEEN RELATIVELY
COMPLETE WITH MUCH OF OUR
ETHNICITY DATA BEING UNKNOWN OR
NOT RECORDED AND THERE HAVE BEEN
EFFORTS TO TRY TO OVERCOME THAT
CHALLENGE.
PERHAPS THAT IS WHAT WE'RE
SEEING.
AND THE NEXT SLIDE.
SO FOR PHASE III TRIAL
ENROLLMENT BY RACE THERE IS SOME
INTERESTING TRENDS THAT HAVE
COME ABOUT OVER THIS REPORTING
TIME FRAME.
MOST NOTABLY THERE IS A
SUBSTANTIAL DECREASE IN THE
ENROLLMENT OF WHITE PARTICIPANTS
IN PHASE III TRIALS.
GOING FROM 48 TO 38 AND THEN TO
32% IN 2021 AND AT THAT SAME
TIME FRAME THERE WAS A NOTABLE
INCREASE IN BLACK OR
AFRICAN-AMERICAN ENROLLMENT IN
PHASE III TRIALS.
SUCH THAT SHOWS WHO
SELF-REPORTED AS BLACK OR
AFRICAN-AMERICAN EXCEEDED THAT
OF WHITE PARTICIPANTS IN PHASE
III TRIALS IN FY2020 AND 21.
SO REALLY REMARKABLE.
I WILL ALSO POINT OUT THAT THE
AMERICAN INDIAN ALASKA NATIVE
PARTICIPATION HAS BEEN LOW AND
THOSE WITH UNKNOWN OR NOT
REPORTED RACE WHILE THE RATES
ARE LESS THAN THAT FOR OVER-ALL
CLINICAL RESEARCH IT DOES
COMPRISE A PROPORTION OF THE
CLINICAL RESEARCH PARTICIPANTS.
JUST TO OFFER A SUMMARY OF WHAT
I AM PRESENTING HERE TODAY.
GENERAL TRENDS.
I WILL MENTION -- OVER-ALL
DECREASED STUDY PARTICIPANT
ENROLLMENT IN THIS CLINICAL
RESEARCH INCLUDING PHASE III
TRIALS AND POSSIBLY AFFECTING
CERTAIN RACIAL AND ETHNIC GROUPS
MORE THAN OTHERS SUCH AS
INDIVIDUAL SELF-REPORTING AS
HISPANIC LATINO ETHNICITY AND
BLACK OR AFRICAN-AMERICAN RACE.
BASED UPON LITERATURE THAT HAS
BEEN PUBLISHED AND WHAT WE KNOW
ABOUT THE PANDEMIC THIS IS
PERHAPS DUE TO THE COVID RELATED
IMPACTS UPON CLINICAL RESEARCH
ACTIVITIES IN THOSE AFFECTING
CERTAIN RACIAL AND ETHNIC GROUPS
MORE THAN OTHERS.
THERE HAVE BEEN A SUBSTANTIAL
AND CONSISTENT NUMBERS OF WOMEN
ENROLLED IN NIDCR STUDIES
INCLUDING PHASE III TRIALS.
OVER-ALL CLINICAL STUDY
PARTICIPATION REFLECTS THAT OF
THE U.S. POPULATION IN SOME BUT
NOT ALL RACIAL AND ETHNIC
CATEGORIES.
FOR EXAMPLE AMERICAN INDIAN AND
ALASKA NATIVE PARTICIPATION DOES
CONTINUE TO BE A CHALLENGE AS
WELL AS I BELIEVE THAT
ENROLLMENT INTO DIVERSE ETHNIC
GROUPS HAS BEEN A CHALLENGE FOR
NIDCR.
PHASE III CLINICAL TRIAL
PARTICIPATION IT'S BEEN SO
ENCOURAGING TO SEE THE
SIGNIFICANT IMPROVEMENT IN BLACK
AND AFRICAN ENROLLMENT IN TRIALS
TO THE EXTENT THIS THESE
INDIVIDUALS COMPRISE THE
MAJORITY OF THE PHASE III
CLINICAL TRIAL PARTICIPATION.
AND MAYBE TO TIE THAT INTO THE
ENGAGING PRESENTATIONS WE'VE
HEARD TODAY THIS IS AN
ILLUSTRATION PERHAPS OF ONE OF
THE THEMES THAT DR. --
PEREZ-STABLE MENTIONED EARLIER
AND ALSO MICHELLE CULP MENTIONED
THAT AS WELL.
AND I WILL ALSO POINT OUT THERE
IS AN -- ANNEX EXPECTATION -- TO
REPORT.
TO MENTION THE PHASE III TRIALS
DO ADDRESS A VARIETY OF ORAL AND
CRANIOFACIAL ISSUES.
SO WITH THAT -- I WELCOME ANY
QUESTIONS OR PERHAPS ANY -- IF
THERE ARE NO QUESTIONS THEN WE
MIGHT NEED TO TRY TO OBTAIN
CERTIFICATION OF THE INCLUSION
DATA.
>> SO DO COUNCILMEMBERS HAVE ANY
QUESTIONS OR COMMENTS?
THE NEXT STEP WOULD BE FOR
COUNCIL TO VOTE ACCEPTANCE OF
THE CONCEPT OF THE REPORT.
AND WOULD ANY MEMBER OF COUNCIL
LIKE TO MAKE A MOTION TO ACCEPT
THE TRIENNIAL REPORT ON NIH
INCLUSION GUIDELINES
>> I MOVE --
>> THANK YOU.
ANYONE LIKE TO SECOND THE MOTION
>> AGAIN SECONDED.
>> AND ALL IN FAVOR.
>> AYE.
>> ANY OPPOSED?
OKAY.
THE NEXT PHASE IS TO MOVE ON TO
THE CONCEPT CLEARANCES.
WE HAVE THREE CONCEPT CLEARANCES
THAT WILL BE PRESENTED TODAY.
AND WE ARE REQUIRED TO DOCUMENT
THE CLEARANCE OF CONCEPTS BY
PRESENTING THE PURPOSE, SCOPE
AND OBJECTIVES IN A PUBLIC FORUM
SUCH AS COUNCIL.
THE COUNCIL MEETING AND GIVING
COUNCIL AMERICAS AN -- MEMBERS AND
THE PUBLIC AN OPPORTUNITY TO
COMMENT.
DR. LOREN A BLACKBERRY
MY COLLEAGUE MELISSA RIDDLE ARE
EXCITED TO PRESENT YOU TO ON BE
HALF OF THE NIDCR A REQUEST FOR
THE REISSUANCE ENTITLED NIDCR
SMALL RESEARCH GRANTS FOR ORAL
HEALTH DATA ANALYSIS.
THIS FUNDING OPPORTUNITY
SUPPORTS TWO TYPES OF GRANT
APPLICATIONS.
INVESTIGATORS MAY PROPOSE TO
ANALYZE THE EXISTING DENTAL,
ORAL OR CRANIOFACIAL DATA.
IT IS DUE TO EXPIRE IN ABOUT
FOUR MONTHS AND WE WOULD LIKE TO
REQUEST A REISSUANCE.
TO PROVIDE SOME BACKGROUND THIS
OPPORTUNITY ENCOURAGES
APPLICATIONS.
PROVIDES LIMITED RESEARCH
SUPPORT INVESTIGATORS FOR UP TO
TWO YEARS.
THE RESPONSE TO THE CURRENT
FUNDING OPPORTUNITY WHICH WAS
FIRST PUBLISHED TWO YEARS AGO WE
HAVE RECEIVED 59 COMPETITIVE
GRANT APPLICATIONS AND SEVEN OF
THEM WERE AWARDED TO
NONINVESTIGATORS.
A INNING WHO THE NINE AWARDEES
78% WERE FEMALES AND 22% WERE
UNDER REPRESENTED MINORITIES.
APPROXIMATELY 43% OF THE AWARDS
PROPOSED -- OF THESE AWARDS --
-- AND
[ INAUDIBLE ] OVER THE YEARS
INVESTIGATORS -- HAVE BEEN VERY
PROACTIVE WITH APPROXIMATELY 80%
OF THE AWARDS RESULTED IN ONE OR
MORE PUBLICATION.
AND THE CURRENT FUNDING
OPPORTUNITIES ARE PART OF A
SERIES IS THAT BEGAN IN 2004.
WE'VE CONTINUED TO RECEIVE OVER
THE YEARS A ROBUST RESPONSE FROM
BOTH JUNIOR AND SENIOR
INVESTIGATORS.
WHO HAVE BEEN PROPOSING EITHER
SECONDARY ANALYSIS OR NEW
STATISTICAL METHODOLOGY.
THIS IS A VERY EFFICIENT WAY TO
UTILIZE DATA THAT HAVE -- BEEN
PRODUCED AS IT IS OUT OF NIDCR
FUNDED RESEARCH AND SO NOW WE
CAN CAPITALIZE ON THE EXISTING
DATA THROUGH ADDITIONAL ANALYSIS
AND NEW HYPOTHESIS.
THE INVESTIGATORS ALSO HAVE AN
OPPORTUNITY TO INTEGRATE DATA.
TO ANSWER SOPHISTICATED RESEARCH
QUESTIONS ON THE CRANIOFACIAL
COMPLEX.
THIS ANALYSIS IN TURN MAY
ENCOURAGE ADDITIONAL
HARMONIZATION.
THIS INCLUDES ALSO GLOBAL DATA
RESOURCES FOR RARE DISEASES AND
FOR -- DATA.
THIS ANALYSIS MAY BE UTILIZED BY
JUNIOR INVESTIGATORS TO APPLY TO
THEN DEVELOP SOME NEW HYPOTHESIS
AND APPLY FOR LARGER GRANT
APPLICATIONS.
ONE OF THE INTERESTING
CHARACTERISTICS OF THIS
OPPORTUNITY IS THE FACT THAT IT
IS DISEASE DIAGNOSTIC.
BECAUSE IT IS NOT RESTRICT.
WE CAN SEE EXAMPLES OF THE BROAD
RANGE.
THAT ARE BEING PROPOSED.
THE MOST RECENT APPLICATIONS
HAVE INVOLVED TMJ.
ACCESS TO DENTAL CARE,
EPIGENETICS.
---SO IT'S A WIDE RANGE OF
TOPICS AND ALSO EXAMPLES OF --
[ INAUDIBLE ] HAVE INCLUDED
NETWORK ANALYSIS.
MACHINE LEARNING AND DEEP
LEARNING TECHNIQUES AND
MULTI-LEVEL LEARNING.
INVESTIGATORS ARE ABLE TO THINK
ABOUT THEIR OWN RESEARCH AND
THEN PROPOSE ANALYSIS OR NEW --
METHODS.
AND --
[ INAUDIBLE ] AND ON BEHALF OF
NIDCR I WOULD LIKE TO THANK YOU
FOR YOUR ATTENTION AND CONSIDERS
OF THE ISSUANCE OF THIS FUNDING
OPPORTUNITY AND I WOULD ALSO
LIKE TO ESPECIALLY THANK
DR. COOPER -- FOR THEIR REVIEW
AND I WOULD LIKE TO NOW INVITE
THEM NOW TO COMMENT ON THE
CONCEPTS.
>> THANK YOU.
THIS IS DAVID COOPER.
I'LL START OFF.
I FEEL THAT BOTH ASPECTS THIS
INITIATIVE ARE IMPORTANT.
BOTH IN DEVELOPING NEW
METHODOLOGY AND ANALYZING
EXISTING DATA.
ONE MIGHT THINK THAT STATISTICAL
METHODS ARE FAIRLY GENERAL BUT
IF WE TAKE INTO SOME CONCEPTS
SUCH AS THE FACIAL ARRANGEMENT
OF THE TEETH IN THE MOUTH THERE
MAY BE METHODS THAT CAN BE
DEVELOPED SPECIFICALLY FOR THAT
THAT WOULD NOT BE RELEVANT TO
ANY OTHER DISEASE AREA.
IT'S IMPORTANT TO DEVELOP NEW
METHODS THAT MAY BE SPECIFIC TO
DENTAL RESEARCH.
IN TERMS OF ANALYZING EXISTING
DATA -- DR. BACCAGLINI MENTIONED
SEVERAL USES BUT WE SHOULD NOT
FORGET EXISTING DATA.
SO NIDCR SPENDS A LOT OF MONEY
ON FUNDING CLINICAL TRIALS AND
OBSERVATIONAL RESEARCH.
AND WHEN THE FUNDING ENDS THE
INVESTIGATORS EITHER THEMSELVES
OR WHAT OTHER INSTITUTES DON'T
HAVE THE RESOURCES TO MAKE MORE
USE OF THE DATA GENERATED AT
LARGE EXPENSE.
ONE OF THE TRIALS FUNDED BY
NIDCR WAS AT THE MOTOR CLINICAL
TRIALS.
AND THEN LAST YEAR SOMEONE FROM
A DIFFERENT INSTITUTE CONTACTED
US AND ASKED US FOR THE DATA
BECAUSE THEY HAD SOME NEW
HYPOTHESIS THAT THEY WANTED TO
ANALYZE.
SO HAVING FUNDING AVAILABLE FOR
PEOPLE TO USE THE DATA THAT HAS
BEEN GENERATED AT GREAT EXPENSE
IS VERY VALUABLE.
SO I STRONGLY SUPPORT THIS
CONCEPT.
>> THANK YOU.
SO TO ADD A LITTLE BIT TO WHAT
DAVID ALREADY MENTIONED.
I'M ALSO EXCITED ABOUT THIS.
CONCEPT SO IN MY OPINION THIS
RESONATES PRETTY WELL WITH
RECENT MAJOR ADVANCES IN THE
AREA OF DATA SCIENCE.
SO I THINK IT'S BECOMING
INCREASINGLY CLEAR THAT THE NEW
DATA GENERATION METHODS THAT
THEY ARE USING IN MANY AREAS OF
SCIENCE SOME OF WHICH CREATE
THIS MASSIVE AMOUNTS OF DATA
NEED TO BE ACCOMPANIED BY DATA
ANALYSIS STRATEGIES.
MY BACKGROUND IS IN THE FIELD OF
GENOMICS WHERE THIS PARADIGM OF
ANALYZING DATA HAS A LONG
TRADITION.
THIS IS INCREASINGLY APPLICABLE.
THOSE WITHIN THE NIDCR FUNDING
PORTFOLIO.
BECAUSE MANY OF THESE NEW TOOLS
CREATE COMPLEX DATASETS.
AND IT'S IMPORTANT TO KEEP IN
MIND THAT OFTEN TIMES THOSE WHO
GENERATE THE DATE SAY ARE
INTERESTED IN ONE PARTICULAR
QUESTION BUT WITH THESE
MULTI-DIMENSIONAL TYPES OF DATA
COLLECTION THERE ARE ENORMOUS
OPPORTUNITIES FOR DOWNSTREAM
SECONDARY ANALYSIS TO GENERATE
POWERFUL INSIGHTS.
AND ANOTHER ASPECT IS THAT
THROUGH THE CLOSE INTERACTION OF
THOSE WHO GENERATE THE DATA AND
THEN THOSE WHO DEVELOP THE TOOLS
TO ANALYZE SUCH DATA. FOR
EXAMPLE UNDER THIS OPPORTUNITY
IT'S POSSIBLE TO OPTIMIZE STUDY
DESIGNS AND DATA COLLECTION
STRATEGIES UP FRONT TO INCREASE
THE POWER OF THE SUBSEQUENT
STATISTICAL ANALYSIS.
RECOGNIZING THIS -- THIS CONCEPT
--
[ INAUDIBLE ] TO TAKE ADVANTAGE
OF THIS APPROACH FOR NIDCR
MISSION CRITICAL NEEDS AND I
BELIEVE THE OUTCOMES FROM
PREVIOUS VERSIONS OF THIS --
DEMONSTRATE THAT IT'S EFFECTIVE
BOTH FOR SECONDARY DATA ANALYSIS
AS WELL AS DEVELOP NEW METHODS
FOR NEW TYPES OF DATA.
ONE FINAL ASPECT IS IS THAT WITH
THE SMALLEST --
[ INAUDIBLE ] IT'S A GREAT
OPPORTUNITY FOR NEW AND EARLY
STAGE INVESTIGATORS AND THIS IS
OBVIOUS FROM THE PAST FUNDING
STATISTICS WHERE NEARLY HALF OF
ALL WERE NEW.
IN SUMMARY I'M ALSO EXCITED AND
FULLY SUPPORTIVE OF THE
REISSUANCE OF THIS FUNDING
OPPORTUNITY.
>> THANK YOU.
ANY OTHER OF COMMENTS FROM
COUNCIL?
WOULD A MEMBER OF COUNCIL LIKE
TO MAKE A MOTION TO RECOMMEND --
[ INAUDIBLE ]
>> SECOND.
[ INAUDIBLE ].
>> LYNN I REALLY APPRECIATE THE
FEEDBACK AND DAVID'S COMMENT ON
WHAT HAPPENS WHEN A STUDY
ACTUALLY ENDS OR IS NO LONGER
FUNDED AND WE HAVE A DATASET
THAT IS ACTUALLY VERY
INFORMATIVE.
HOW DO WE MAINTAIN A CONTINUUM
OF INQUIRY INTO THESE IMPORTANT
AREAS.
THAT WILL NEED FOLLOW-UP.
WE CAN DO OUR OWN ANALYSIS AND
COME UP WITH WAYS IN WHICH WE
CAN LEVERAGE FROM WORK THAT IS
NO LONGER ACTIVE FOR ONE REASON
OR THE OTHER.
>> THANK YOU.
>> LET ME FINISH THE VOTE.
>> OH, YEAH.
SORRY.
>> THAT'S OKAY.
ALL IN FAVOR.
>> AYE.
>> AND ANY OPPOSED?
>> OKAY.
GREAT.
THANKS.
DR. MELISSA GHIM.
WILL PRESENT THE NEXT CONCEPT.
>> THIS CONCEPT -- FOR IMPROVING
PATIENT CENTERED TRANSLATIONAL
RESEARCH OR TMD IMPACT.
THE PRIMARY GOAL OF THIS CONCEPT
IS TO ADVANCE BASIC CLINICAL
RESEARCH AND TRANSLATION TO
EVIDENCE BASED TREATMENTS AND
IMPROVED CLINICAL CARE.
VIA THE ESTABLISHMENT OF A
NATIONAL INTERDISCIPLINARY.
-- I ALSO WANT TO HIGHLIGHT THE
INTERDISCIPLINARY NATURE TO BE
IMPLEMENTED IN THE COMPOSITION
OF THE TEAM AS WELL AS
APPROACHES INCLUDING THE
CONSIDERATION OF CO-MORBIDITIES
AND CO-OCCURRING PAIN
CONDITIONS.
AND FINALLY IT'S IMPORTANT TO
REITERATE THAT IT WILL BE
PATIENT CENTERED.
TMD RESEARCH FROM PATIENT CARE
LAGS BEHIND ADVANCES IN OTHER
MUST COULD YOU LOW SKELETAL,
JOINT AND PAIN DISORDERS DUE TO
FACTORS SUCH AS COORDINATED
INTERDISCIPLINARY
--
>> SO SPECIFIC AREAS OF INTEREST
FOR THIS CONCEPT -- INCLUDE
MECHANISTIC UNDER PINNINGS OF
SUBGROUPS AND PHENOTYPES AND THE
EYE QUAKE AND VALIDATION OF
TARGETS FOR DIGITALS, PREVENTION
AND TREATMENT OR THEIR CLINICAL
END POINT.
THE ESTABLISHMENT OF BEST
PRACTICES FOR INTEGRATED
CLINICAL MANAGEMENT IN THE
CONTEXT OF -- PAIN MANAGEMENT OR
CO-MORBIDITIES.
TO FACILITATE ACCESS TO THE TMJ
JOINT AND TO ADVANCE CURRENT
STANDARDS OF DETECTION AND
MEASUREMENT.
ALSO THE USE OF ARTIFICIAL
INTELLIGENCE, MACHINE LEARNING
AND DEEP LEARNING INCLUDING
COMPUTATIONAL METHODS FOR LARGE
DATASETS FOR PURPOSES SUCH AS
INTEREST -- INTEGRATION OF DATA.
ANOTHER AREA OF INTEREST IS
STRENGTHENING THE EVIDENCE BASED
FOR EXISTING TREATMENTS
INCLUDING PRAGMATIC TRIALS AS
WELL AS DEVELOPMENT AND
DISSEMINATION OF NEW EVIDENCE
BASED TREATMENTS.
INTERVENTIONS THAT ALLOW EARLIER
DIAGNOSIS OF PREVENTION STEMMING
FROM DEGENERATIVE CAUSES.
THIS IS NOT ALL-INCLUSIVE.
SO WHAT WOULD THIS LOOK LIKE?
HOW WOULD THE COLLABORATIVE
MANIFEST.
SHOWN HERE ARE TWO POTENTIAL
MODELS.
7 THE FIRST EXAMPLES A CLASSIC
MODEL THAT IS FREQUENTLY USED BY
HEAL.
OR THE NEW HEAL PRECISION
NETWORK AND THIS CONSIST OF A
COORDINATING AND DATACENTER
SERVING AS A CENTER OF
ADMINISTRATIVE HUB AND RESOURCE
SUPPORTING SPECIALIZED RESOURCE
CENTERS.
THIS IS ALSO USED BY HEAL --
EPIC SENATE.
ANOTHER POSSIBLE MODEL DEPENDING
ON THE INPUT OF PARTNERS IS TO
STRUCTURE THE COLLABORATIVE AS A
CLUSTER OF SPECIALIZED CENTERS.
THE DENTAL, ORAL AND
CRANIOFACIAL TISSUE REGENERATION
CONSORTIUM UTILIZES THIS
STRUCTURE.
SO I'LL CONCLUDE WITH THE
DEPICTION OF AN EARLY EXAMPLE OF
AN -- USING INTEGRATED AND
SYSTEMS BIOLOGY.
FROM THE LAB OF -- THIS IS AN
ILLUSTRATION OF THE THOUSAND OF
KNOWN REACTIONS OCCURRING INSIDE
OUR BODIES AND THIS IS BEING
USED TO ILLUSTRATE THE POINT
THAT THIS COLLABORATIVE
CAPITALIZES ON THE IDEA OF THE
WHOLE BEING GREATER THAN THE SUM
OF ITS PARTS.
BY BRINGING TOGETHER RESOURCES
AS WELL AS DIVERSE THINKING AND
APPROACHES TO FOCUS ON TARGETED
PRIORITIZED RESEARCH QUESTIONS
AND CHALLENGES WE CAN OBTAIN THE
GREATER THAN BENEFIT.
THE ADVANTAGE THAT A MULTI-LEVEL
COORDINATED PARTNERSHIP CAN
DELIVER THAT IS OVER AND BEYOND
WHAT SINGLE INVESTIGATORS CAN
DELIVER.
SO WITH THIS I'LL TURN THIS OVER
TO OUR COUNCILMEMBERS TO
DISCUSS.
>> HELLO, EVERYONE.
I'M CLARKE STANFORD.
THANK YOU FOR THE PRESENTATION.
WE HAD THE OPPORTUNITY ON THE
7th OF JANUARY TO REVIEW THIS
WITH YOU.
AND I THANK YOU FOR YOUR TIME.
THIS IS AN OUTGROWTH OF THE
ACTIONS AND OPPORTUNITIES THAT
CAME OUT OF THE INSTITUTE OF
MEDICINE REPORT THAT THEN LED TO
AN INTER COUNCIL GROUP.
WE WORKED OVER TIME TO COME UP
WITH THE CONSTRUCT TO HELP NIDCR
IN TERMS OF HOW TO RESPOND TO
THAT INSTITUTE OF MEDICINE
REPORT.
ONE OF THE THINGS THAT CAME OUT
OF THIS WAS THE IDEA THAT TMJD
IS NOT AN ENTITY THAT LIES
WITHIN ANY ONE DISCIPLINE OR
LIES WITHIN ANY ONE INSTITUTE.
HISTORICALLY MANY TIMES BECAUSE
TMJD TENDS TO HAVE A MANAGEMENT
BY A DENTAL COMMUNITY AS ONE
POTENTIAL -- IT HAS FALLEN TO
NIDCR AND THIS LED TO THE GREAT
WORK DONE BY BILL -- WITH THE
STUDY BUT THE QUESTION NOW RISES
IS IT TIME FOR A NEW DAY AND TO
BRING IN MANY OF THE OTHER
COLLABORATIVE GROUPS THAT HAVE
EXPERTISE THAT DON'T NECESSARILY
GET APPLIED TO THE ASPECTS AND
ISSUES OF TMJD.
AS YOU HEARD EARLIER NIDCR IS
STARTING TO ADDRESS THIS TO DEAL
WITH AT THE CELLULAR LEVEL WHAT
MAY BE UNDERLYING POTENTIAL
MECHANISMS TO TARGET.
WHEN YOU LOOK AT THE REPORT THE
ASPECT THAT THERE IS AT LEAST 30
DIFFERENT PET GENIUS HEALTH
DISORDERS -- * EMPHASIZES A
SIGNIFICANT AMOUNT OF WORK IS
NEEDED SO THAT BASIC MECHANISMS
CAN BE TARGETED SO THERE IS THE
POTENTIAL FOR GREATER
UNDERSTANDING OF PREVENTION
FOLLOWED BY DIGITA DIAGNOSIS AND BY
THERAPEUTIC INTERVENTIONS THAT
HAVE EVIDENCE TO SHOW
SIGNIFICANT PATIENT RELATED
OUTCOMES.
WHAT WAS PROPOSED HERE IS THE
FIRST STEP IN OUR CONVERSATIONS
AND THIS IS A NATIONAL
INTERDISCIPLINARY AND THIS IS
NOT GOING TO BE SOMETHING THAT
LIES WITHIN NIDCR BUT IN NIDCR
WILL BE ABLE TO TAKE THE LEAD IN
TERMS OF BRINGING TOGETHER A
VARIETY OF DIFFERENT
INVESTIGATORS AND I WOULD
INCLUDE PATIENT ORIENTED GROUPS
BECAUSE THEIR VOICE IS NEEDED IN
TERMS OF THE OUTCOME MEASURES
AND THEY ARE IMPORTANT IN TERMS
OF THE SOCIAL MEDIA OF BEING
ABLE TO GET THE CORRECT
SCIENTIFIC MESSAGING OUT.
SO FROM DAY ONE THAT WOULD BE TO
ME SOMETHING TO HIGHLY RECOMMEND
AS A PART OF SUCH CONSORTIUM.
IS BRINGING IN THE PATIENT
RELATED COMMUNITIES OF INTEREST
INTO THIS.
A KEY PART OF THIS IS ALSO THE
TRAINING THE NEXT GENERATION.
AS YOU HEARD EARLIER TRAINING
FOR NIDCR IS EXTREMELY
IMPORTANT.
WE'RE TALKING ABOUT THE TEAM
SILENCED INDICATION AND TRAINING
THAT IS NEEDED AROUND COMPLEX
ISSUES OF CHRONIC PAIN AND IN
DISABILITIES THAT CAN BE A
ASSOCIATED WITH THIS.
THAT IS WHY THIS CONCEPT OF A
COLLABORATION IS CRITICALLY
IMPORTANT IN MY OPINION TO MOVE
FORWARD AND I WOULD STRONGLY
ENCOURAGE COUNCIL TO ENDORSE
THIS.
THANK YOU.
DR. ALBERS.
>> YES.
I TOTALLY SUPPORT AND AGREE WITH
EVERYTHING THAT WAS SAID.
THIS IS SUCH A NEEDED AREA FOR
RESEARCH IN TERMS OF THE
CLINICAL OUTCOMES AS WELL AS AT
THE BASIC SCIENCE LEVEL.
WE JUST DON'T KNOW ENOUGH ABOUT
THIS REALLY COMPLEX JOINT.
ABOUT HOW PAIN RELATED TO TMJ
DISORDER OR CONDITIONS MANY
TIMES THEY INTERSECT WITH OTHER
INFLAMMATORY CONDITIONS OF THE
BODY.
THIS WOULD BE AN OPPORTUNITY TO
REALLY GET A HOLD ON WHAT TYPES
OF PATIENT GROUPS ARE OUT THERE
IN TERMS OF THE TYPES OF TMDs
AND TO RELATE IT BACK TO BASIC
SCIENCE STUDIES IN ORDER TO
DEVELOP APPROACHES IS THAT WILL
BE EFFECTIVE IN TREATING THESE
DISORDERS.
I KNOW SEVERAL PEOPLE THAT HAVE
TMD AND IT'S REMARKABLE THAT AS
A PERSON IN THE PAIN RESEARCH
FIELD YOU SPEAK TO THEM AND SAY
WERE YOU TREATED AND DID IT
WORK?
ALMOST EVERY TIME NO.
NO.
SOME RESOLUTION BUT IT WAS NEVER
TREATED SUFFICIENTLY.
SO THERE IS SUCH A NEED HERE TO
REALLY UNDERSTAND WHAT IS GOING
ON WITH THESE DISORDERS AND THIS
IS CERTAINLY AN AMBITIOUS
INITIATIVE BUT IT'S SO NECESSARY
TO ADVANCE UNDERSTANDING IN THIS
AREA.
SO I REALLY SUPPORT APPROVAL OF
THIS CONCEPT BY THE COUNCIL.
>> ANY OTHER QUESTIONS OR
COMMENTS?
>> LYNN, IT'S JOEL STROM
CALLING.
HOW ARE YOU DOING?
>> GOOD.
>> I SUPPORT EVERYTHING THAT HAS
BEEN SAID.
BUT THERE IS ONE AREA THAT I
LEARNED ABOUT RECENTLY THAT HAS
BEEN EFFECTIVE AT LEAST IN OUR
AREA OF TOWN HERE IN LOS ANGELES
AND THAT HAS TO DO WITH TMS
TREATMENT AND APNEA.
AND LEARNING MORE ABOUT HOW THAT
IS INTERTWINED -- CAN BE
INTERTWINED WITH TMD ISSUES.
SO I WOULD LIKE TO PUT A WORD IN
AND A FOCUS ON SLEEP RELATED
CAUSES AND THEN THEREFORE
TREATMENTS THAT MIGHT BE
INVESTIGATED.
THERE IS A LOT OF FROM MY
PERSPECTIVE INTERRELATED ISSUES
THAT COME UP WITH SLEEP.
THE CONCEPT OF PROPER SLEEP AND
TMD PAIN AND IN MY PATIENTS I
FOUND IT TO BE EFFECTIVE.
PSYCHOSOCIAL FACTORS, MAYBE THAT
IS WHERE IT MIGHT FIT BUT IF YOU
DO A CLUSTER APPROACH PERHAPS
THERE WOULD BE ONE RELATED TO
SLEEP ISSUES.
>> ANY OTHER COMMENTS?
OR QUESTIONS?
IF NOT WOULD A MEMBER OF COUNCIL
LIKE TO MAKE A MOTION,
RECOMMENDATION TO APPROVE THIS
CONCEPT?
>> THIS IS AMY.
I'LL MAKE A MOTION
>> I'LL SECOND IT.
>> ALL IN FAVOR.
AYE.
>> ANY OPPOSED?
OKAY.
DR. ZHONG CHEN.
COUNCILMEMBERS WHO ARE INVITED
TO COMMENT ARE DR. GARCIA AND
SHI.
>> HI, EVERYONE.
MY NAME IS ZHONG CHEN.
TODAY I'M GOING TO PRESENT A
CONCEPT AHEAD.
WHICH STANDS FOR THE ADVANCEMENT
OF HEAD AND NECK CANCER EARLY
DETECTION RESEARCH.
[ INAUDIBLE ] HOWEVER WHEN WE
LOOK -- HUMID HPV IS SPONGE FOR
UP TO 70% OF THE CANCER IN THE
UNITED STATES.
*.
--
[ INAUDIBLE ] ALSO HIGH NECK
CANCERS -- ARE QUITE LIKELY TO
AFFECT MEN RATHER THAN WOMEN.
AFRICAN-AMERICAN MEN -- --
[ INAUDIBLE ]
[ INAUDIBLE ] CERTAIN CERTAIN
[ INDISCERNIBLE ]
SO CURRENTLY THE RESEARCH GAP --
LIMITED BIOMARKERS -- THAT CAN
PREDICT EARLY ORAL LESION
PROGRESSION TO CANCER AND ALSO
LACK OF SYSTEMATIC DISCOVERY AND
VALIDATION OF POTENTIAL
BIOMARKERS FOR CLINICAL USAGE.
SO THE RESEARCH OPPORTUNITY TO
UNDERSTAND THE MOLECULAR
CHARACTERISTICS OF DYSPLASTIC
LESIONS AS WELL AS EARLY
RECURRENCE AND METASTASIS TO
IMPROVE ORAL LESION
CLASSIFICATION AND A PREDICTOR
OF CANCER PROGRESSION.
AND WE ESTABLISHED PARTNERSHIP
WITH NCI TO INTERACT WITH THE
EARLY DETECTION NETWORK AND WE
HAVE A LONG HISTORY WITH NCI AND
MANY OTHER PROGRAMS SUCH AS THE
MOONSHOT PROGRAM AND THE SPORE
PROGRAM.
THE SPECIFIC AREA OF INTEREST
FOR THE RESEARCH TOPICS INCLUDE
DISCOVER MOLECULAR GENOMIC,
IMMUNOLOGICAL, CELLULAR,
MICROBIOME AND IMAGING
SIGNATURES.
EVALUATE BIOMARKERS AND
TECHNOLOGIES WHICH CAN
COMPLIMENT CURRENT CLINICAL
METHODS.
ALSO TO DEVELOP THE TOOLS AND
METHODS FOR DETECTING BIOMARKERS
IN BODILY FLUIDS.
AND ALSO WOULD LIKE TO INTEGRATE
THE HIGH THROUGH PUT
TECHNOLOGIES WITH DATA SCIENCE
-- ARTIFICIAL INTELLIGENCE AND
MACHINE LEARNING AND DEEP
LEARNING FOR THE VALIDATION
PROCESS.
AND TO IDENTIFY FACTORS OF
NUTRITION OR EARLY DETECTION OF
CANCER INCLUDING NUTRITION,
MICRO BIOME, ORAL HEALTH AND
HEALTH DISPARITY.
I WILL STOP HERE.
THANK YOU FOR YOUR ATTENTION.
>> THANK YOU.
WE HAD THE OPPORTUNITY TO MEET
WITH DR. CHEN AND DISCUSS THE
CONCEPT.
THE CONCEPT -- ADDRESSES THIS.
IMPORTANTLY THE OVER-ALL PROGRAM
THE AHEAD PROGRAM PROPOSED BY
THIS CONCEPT CLEARANCE HAS VERY
HIGH CLINICAL AND PUBLIC HEALTH
RELEVANCE.
TO ACCELERATE RESEARCH AND AIMS
TO MEET KEY GAPS AND KNOWLEDGE
BY BUILDING ON TIMELY
OPPORTUNITIES INCLUDING MANY
ADVANCEMENTS MADE IN HIGH
THROUGH PUT TECHNOLOGIES AS WELL
AS COMPUTATIONAL TECHNOLOGY.
THE PARTNERSHIP WITH NCI WILL
FACILITATE WITH THE EARLY
DETECTION NETWORK AS WELL AS
YIELD ACCESS TO OTHER IMPORTANT
RESOURCE THAT'S WILL CLEARLY
ENHANCE THE INVESTIGATORS TO
ACHIEVE THEIR GOALS.
WE DISCUSSED SOME OF THE
CHALLENGES REGARDING
OPERATIONALIZING THIS CONCEPT.
SOME OF THE CHALLENGES INCLUDED
THE BASIC AND VERY AMBITIOUS
GOAL AND THE SCOPE OF THE
CONCEPT.
WE SUGGESTED TO CONSIDER THE
BENEFITS OF TAKING A MORE
FOCUSED APPROACH.
LIMITING THE SCOPE IS TO ORAL
CAVITY.
AND SALIVARY GLAND TUMORS.
THE OTHER WAS THE OVER-ALL
READINESS FOR TRANSLATION.
IN ORDER TO ACCELERATE
TRANSLATION ONE NEEDS A CERTAIN
FOUNDATION OF SCIENTIFIC
FINDINGS TO TRANSLATE.
THE INSTITUTES PORTFOLIO HAS
ONLY HAD A HANDFUL OF STUDIES.
CLEARLY THERE IS A NEED TO
ACCELERATE IN THIS AREA BUT THE
QUESTION IS EVEN THOUGH THE NEED
FOR MORE WORK IS APPARENT IS
THERE SUFFICIENT PROGRESS MADE
ALREADY TO MOVE SUCCESSFULLY
INTO THE TRANSLATION PHASE.
AND LAST BUT NOT LEAST FOR
MOVING AHEAD IS TO LEARN FROM
THE PAST.
TO WHAT EXTENT CAN WE LEARN
ABOUT SIMILAR PAST EFFORTS AT
THE INSTITUTE THAT CAN BETTER
INFORM PLANNING FOR THIS ONE.
A DECADE AND A HALF AGO -- IN
THE AREA OF SALIVARY
DIAGNOSTICS.
WHAT HAVE WE LEARNED AND CAN
APPLY MOVING FORWARD.
ENTHUSIASTIC ABOUT MOVING
FORWARD WITH THIS AND NOW I'LL
TURN IT OVER TO DR. SHI
>> A COMPLETELY AGREE WITH
DR. GARCIA'S ASSESSMENT.
AND WE HAD A GREAT CONVERSATION
WITH DR. CHEN AND DR. MALIO.
AND WE ALL AGREED THIS IS A VERY
WELL RETURN PROPOSAL ADDRESSING
SOME IMPORTANT AREAS.
TO ME ONE OF THE MOST EXCITING
THINGS IS MOST OF THE DENTAL
RESEARCH -- FOCUSED ON THE OSCC
AND BY ELEVATING TO THE HEAD AND
NECK CANCER AND HOPING WE WILL
BE PROMOTING MORE PEOPLE IN THE
ENT AREA TO BE INVOLVED IN THIS
OVER-ALL HEAD NECK CANCER
ACTIVITY.
7 SO HAVING THIS AS A JOINT
EFFORT WITH NCI IS GREAT.
WE'RE EVEN THINKING COULD EXTEND
TO MORE INSTITUTES THAT ARE
INVOLVED IN THE HEAD AND NECK,
NASAL AND EYE AREA SINCE THEY
ARE ALL PART OF THE SAME SYSTEM.
7 THE ONLY CONCERN FROM MY END
IS WE CAN ONLY CONTINUE DOING
THE EARLY DISCOVERY AND THERE IS
A LOT OF WORK ALREADY BEEN DOING
AND TRY TO FIND A BIOMARKER
RELATED TO THE ORAL CANCER IN
SALIVA.
SO I THINK IT'S VERY IMPORTANT
TO TRY TO AVOID TO REPEAT THE
OLD WORK.
7 AND WE WILL BRAINSTORM HOW WE
CAN GUIDE THIS PARTICULAR
PROPOSAL AND TO ASK FOR
INTRODUCING SOME OF THE NEW
TECHNOLOGIES LIKE AI AND THE
MORE LOOKING AT MORE BROADER
APPROACH INSTEAD OF JUST THOSE
OLD EARLY DISCOVERY PROCESSES SO
WE'RE NOT REPEATING THE EFFORT.
THAT IS REALLY -- WAS THE MAIN
CHALLENGE OF THIS PROPOSAL.
BUT THIS IS A VERY IMPORTANT
AREA AND WE NEED TO SPEND MORE
MONEY ON IT SO WE'RE VERY GLAD
TO SEE THERE IS SUCH A PROPOSAL
ON THE TABLE.
>> THANK YOU.
>> SO THIS IS -- THANK YOU.
THAT IS JACYUE -- NOR.
I WANT TO THANK DR. CHEN FOR
PUTTING THIS TOGETHER.
IT'S TIMELY AND IMPORTANT.
* S. I WANT TO COMMENT THAT THIS
ALIGNS VERY WELL WITH THIS
CONCEPT -- OF SOME OF THE MAIN
TOPIC THAT'S WERE BROUGHT UP
LAST WEEK IN THE THINK TANK
DISCUSSION THAT WE HAD THAT WAS
JUST AS SPECTACULAR.
THEY WERE ABLE TO PUT TOGETHER A
GREAT GROUP OF PEOPLE TO HAVE
THAT CONVERSATION.
SO THIS BIOMARKER IS VERY, VERY
IMPORTANT.
OF COURSE, WHILE I'M THINKING
THAT SOME OF THE ASPECTS THAT
DR. GARCIA AND DR. SHI BROUGHT
UP -- FOCUSING MORE ON THE SCOPE
AND PERHAPS GUIDING THE --
TOWARDS INNOVATIVE TECHNOLOGIES.
THIS IS VERY IMPORTANT CONCEPTS.
I WANT TO BRING UP ONE MORE
SUGGESTION HERE PERHAPS.
7 THE CONCEPT OF RESPONSE TO
TREATMENT.
IN USING BIOMARKERS TO HELP
GUIDE TREATMENT INTENSITY AND
THE PRINCIPLE OF TUMOR RELAPSE
MIMICS IN MANY WAYS BUT IT'S
ALSO DIFFERENT IN OTHER WAYS TO
THROUGH EARLY LESIONS AND
PRIMARY LESIONS SO PERHAPS THAT
IS ONE AREA THAT COULD ALSO BE
FOSTERED IS THROUGH THIS RFA IS
THE DISCOVERY OF BIOMARKERS FOR
TUMOR RELAPSE AND USE OF THIS
BIOMARKERS TO MODULATE TREATMENT
INTENSITY.
THIS HAS BECOME QUITE IMPORTANT
NOW ESPECIALLY WITH HPV POSITIVE
TUMORS THAT PERHAPS ONE CAN
DEESCALATE THE INTENSITY OF
TREATMENT IF ONE HAS GOOD-BYE OH
MARKERS TO DETECT RESPONSE.
THANK YOU FOR THE OPPORTUNITY TO
SAY A COUPLE OF WORDS HERE.
*.
ANY OTHER COMMENTS?
IF NOT -- WOULD A COUNCILMEMBER
LIKE TO MAKE A MOTION.
>> SO MOVED.
>> A SECOND?
>> SECOND.
ALL APPROVE?
>> AYE.
>> AND ANY OPPOSED?
OKAY.
AT THIS POINT WE HAVE REACHED
THE END OF THE OPEN SESSION.
I WANT TO REMIND EVERYONE THAT
YOU MAY SUBMIT COMMENTS OR
QUESTIONS ABOUT THE OPEN SESSION
TO THIS MAILBOX POSTED HERE AND
YOU MAY SUBMIT QUESTIONS OR
COMMENTS BY FEBRUARY 11, 2022.
AND I WILL NOW TURN THE MEETING
BACK TO DR. RENA DE REMEMBER -- DR. DEE SO UZA.
*.
THEY TIED IN THE THEME OF US
LEVERAGING SCIENCE AND
TECHNOLOGIES SO MUCH MORE FULLY
SUCH THAT WE CAN ACTUALLY CREATE
REDUCTIONS IN DISPARITIES THAT
EXIST THROUGHOUT OUR SYSTEM AT
MANY LEVELS.
RIGHT.
SO THERE IS THAT AND THE REASON
IT BECOMES CENTRAL TO ME IS THAT
NIDCR IS FUNDED BY TAXPAYERS.
WE WERE FOUNDED ON THE BASES OF
PUBLIC HEALTH WHEN FLUORIDE
BECAME A WONDERFUL INTERVENTION
AND COMMUNITY FLUORIDATION IT
WAS AT THE TIME WHEN THE COUNTRY
HAD EXPERIENCED MEN OVER 45
LOSING PRACTICALLY ALL OF THEIR
TEETH AND VETERANS AND THOSE
SIGNING IN TO BE ENLIST EDUCATED
SUCH BAD 10 TALL -- THAT HEADED
PRESIDENT HARRY TRUMAN T -- --
MAKING ORAL HEALTH POSSIBLE FOR
ALL AND WE HAVE MULTIPLE LAYERS.
ITSELF THINK OF COMPLEXITY BUT
WE'LL ALSO HAVE A TIGHT-KNIT
COMMUNITY THAT WE WILL RELY ON.
OUR STAKE HOLDERS WHO ARE WELL
KNIT IN WITHIN NIDCR AND STAND
BY TO SUPPORT US SO WE CAN FORGE
AHEAD.
BUT YOU ALSO HEARD THREE
CONCEPTS THAT SO ALIGN WITH OUR
STRATEGIC PLAN.
AND I WILL BE CONSTANTLY I THINK
ALL OF US ARE GOING TO BE
CROSS-CHECKING WHAT WE DO WITH
WHAT WE HAD PROPOSED TO DO OVER
THE NEXT FIVE YEARS.
WE MAY NOT ACCOMPLISH EVERYTHING
BUT IT IS WORTH THE EFFORT RIGHT
NOW BECAUSE THE TIME IS RIGHT
AND THE STARS ARE IN FACT
ALIGNED.
AND YOU WILL NOTICE THAT IT'S A
DISEASE AGNOSTIC AND IT'S NOT
JUST BECAUSE I AM.
BUT IT'S BECAUSE OF THE CAUSE --
CALLS FOR ACTION.
SO WE HAVE THE STATISTICS OF
HAVING CARRIES AS THE MOST
COMMON CHILDHOOD DISEASE.
PERIODONTAL DECEASE.
AND HPV RISING TO THE TOP.
* ALL OF THAT COMES ATTENTION TO
TO INDICATE THAT THE
RESPONSIBILITY IS ON US.
AND FOR THAT REASON I APPEAL TO
COUNCIL AND TO ALL WHO ARE
LISTENING TO ENGAGE WITH NIDCR
FURTHER AND WE HAVE AS
>> Jacqueline: MENTIONED THAT *
THINK TANK SECTION WAS USEFUL
AND THERE ARE SO MANY TOPICS
THAT WE CAN EXPLORE AND SO, THAT
IS GOING TO HAPPEN ALONG WITH
WORKING GROUPS OF COUNCIL.
SO I WANT TO THANK YOU ALL FOR
LISTENING IN PATIENTLY AND FOR
YOU MORE THAN EVER STAYING
CONNECTED WITH US IN THESE TIMES
IN THESE VIRTUAL TIMES WHEN
HUMAN CONNECTIONS AND SCIENCE
HAVE NEVER BEEN MORE IMPORTANT
THANK YOU VERY MUCH.
AND WITH THAT I THINK WE CAN
TAKE A BREAK BEFORE WE GET INTO
CLOSED SESSION.
>> I HAVE ONE FINAL ANNOUNCEMENT
FOR EVERYONE.
THAT OUR NEXT COUNCIL MEETING
WILL BE MAY 18th AND I HOPE
YOU WILL JOIN US.
IT WILL BE ANOTHER VIRTUAL
SESSION.
AND YES WE WILL TAKE A BREAK.
AND WE CAN -- IF WE CAN RETURN
AT 2:30.
FOR THE CLOSED SESSION OF
COUNCIL.