I THINK EVERYONE IS HERE.
OUR COUNCIL MEMBERS AND GUESTS.
I'M GOING TO IT TO DR. CHIANG
FOR REMARK.
>>THANK YOU FOR PUTTING THIS
TOGETHER.
I'D LIKE TO WELCOME EVERYONE TO
THE 163rd MEETING OF THE
NATIONAL ADVISORY EYE COUNCIL.
WE HAVE A GOOD PROGRAM CATHY HAS
PUT TOGETHER AND TWO FANTASTIC
GUEST SPEAKERS COMING ON LATER
TODAY AND WE'LL INTRODUCE THAT
AS WE GET CLOSER TO TIME.
FOR NOW, I'D LIKE TO DO A ROLL
CALL OF THE COUNCIL MEMBERS.
I'LL CALL PEOPLE'S NAMES IN
ALPHABETICAL ORDER.
IF YOU CAN UNMUTE AND INTRODUCE
YOURSELF.
>>I AM A PROFESSOR EMERITUS AT
THE UNIVERSITY OF NORTH CAROLINA
CHAPEL HILL.
MY INTEREST IS GLAUCOMA AND
VISION.
>>JAMES, PLEASE.
>>I'M A SENIOR SCIENTIST IN SAN
FRANCISCO.
MY RESEARCH FOCUSES ON
ACCESSIBILITY TOOLS MAKING A
SMARTPHONE APP FOR INDOOR TURN
BY TURN SETTINGS OR TOUCHING.
THANK YOU.
>>I'M FROM BOSTON.
I'M PROFESSOR AND SENIOR
SCIENTIST IN OPHTHALMOLOGY AND
IMMUNOLOGY AT HARVARD.
>>NEXT, I HAVE KATIA.
>>
>>MY INTEREST IS TO STUDY EYE
TISSUE REGENERATION USING ANIMAL
MODELS AND FOCUSSING ON
ENDOGENOUS RESOURCES FOR RETINA
REPLACEMENT AND CELLS ALSO.
>>AND TOM.
>>I'M AN OPHTHALMOLOGIST AT THE
UNIVERSITY OF MICHIGAN AND TREAT
RET
RETINOPATHY.
>>I HEAR YOU'RE AROUND THE
WORLD.
>>I'M IN PERTH, AUSTRALIA.
>>THANKS FOR CALLING IN.
>>I'M A PROFESSOR OF
OPHTHALMOLOGY AND VISUAL
SCIENCES AT THE UNIVERSITY OF
UTAH.
MY AREA AND I'M A SURGEON AND I
STUDY THE PATH OF PHYSIOLOGY AND
RETINOPATHY IN MACULAR
DEGENERATION.
>>I STUDY EPIGENETICS AND
MITOMITO
K
MITO
MITOCONDRIA.
>>MY INTEREST IS IN CLINIC
RESEARCH PARTICULARLY
MULTI-CENTERED RESEARCH AND
RETINAL DISEASE.
>>I HAVE BEN.
>>I'M A CLINICAL OPTOMETRIST
AND FIVE MINUTES FROM YOU GUYS
FROM THE ROCKLEDGE COUNCIL AND I
SPECIALIZE IN KERATOKONOSIS AND
A DRY EYE DISEASE.
>>MY UNDERSTANDING IS TERRYN IS
ILL.
>>HE BASICALLY STUDIES NEURAL
MECHANISMS OF VISUAL PERCEPTION
AND VISUALLY GUIDED BEHAVIORS.
I'D LIKE TO INTRODUCE TWO NEW
COUNCIL MEMBERS AND I'D LIKE TO
JUST SHOW TWO SLIDES OF THEM IF
THAT'S OKAY.
I'LL TRY TO INTRODUCE AND THEN
AFTER IF YOU CAN UNMUTE AND SAY
HELLO WE'D LIKE THAT.
THE FIRST IS AN ATTORNEY AND
ADVOCATE AND HAS SERVED AS A
SENIOR DISABILITY POLICY ADVISER
TO PRESIDENTIAL AND
GUBERNATORIAL CAMPAIGNS AND
STATE ELECTION CAMPAIGNS.
JENNY'S HAD A NUMBER OF
SIGNIFICANT NATIONAL BOARD
PROIMENTS INCLUDING TO THE
AMERICAN FOUNDATION FOR THE
BLIND AND THE FIGHTING BLINDNESS
AND TO NASEM AND LECTURED
FREQUENTLY ON ISSUES INVOLVING
PEOPLE WITH DISABILITIES AND
EXCITED TO HAVE JENNY ON THE
COUNCIL.
WOULD YOU LIKE TO UNMUTE AND
INTRODUCE YOURSELF TO THE GROUP?
>>THANK YOU.
>>I KNOW THERE'S A SIGNIFICANT
DIFFERENCE IN THE BACKGROUND
THAT I COME WITH I'M MORE OF THE
KIND THAT SHAKESPEARE REFERRED
TO WHEN HE SAID FIRST THING
WE'LL DO IS LET'S KILL ALL THE
LAWYERS.
MY PERSPECTIVE COMES FROM BEING
A PERSON IMPACTED BY BLINDNESS
AND DIAGNOSED WITH RETINITIS
PIGME
PIGMENTOSA AND THE BOARD YOU
MENTIONED IS ON THE FORUM OF
AGE, DISABILITY AND
INDEPENDENCE.
GLAD TO BE WITH YOU.
>>THANK YOU.
AND WE'RE EXCITED ABOUT THE
PERSPECTIVE YOU'LL ADD TO THIS
GROUP.
>>NEXT IS A PROFESSOR AT DUKE
AND HAS EXPERTISE AND WE'RE
EXCITED HE'LL BRING EXPERTISE
COMBINING THE ROLE OF
INFLAMMATION WITH EYE DISEASE
AND INTERIOR SEGMENTS OF EYE
DISEASE AND HAS EXPERIENCE IN
CLINICAL TRIALS AND LED
INITIATIVES BRIDGING IN
SCIENTISTS FROM GROUPS CURRENTLY
UNDER REPRESENTED IN VISION
RESEARCH.
>>GOOD MORNING, EVERYONE.
IT'S MY PLEASURE TO BE A MEMBER
OF THE COUNCIL.
THE BEST WAY TO PAY BACK IS BY
HELPING THE SYSTEM CONTINUE TO
WORK.
I'M VERY EXCITED TO BE HERE
BRINGING IN A DIFFERENT
PERSPECTIVE.
THANK YOU AND I'M LOOKING
FORWARD TO WORKING WITH ALL OF
YOU.
>>THANK YOU, VICTOR.
CATHY, CAN I TURN TO YOU AND
THEN WE'LL GET STARTED.
>>THANK YOU, EVERYONE.
WELCOME AND ESPECIALLY TO JENNY
AND VICTOR AND HOPE TO HAVE YOU
ONBOARDED SOON AND THANK YOU FOR
YOUR PATIENCE AS WE NAVIGATE THE
HURDLES AND THANKS TO THE
COUNCIL MEMBERS AND STAFF AND
CAREFUL PREPARATION FOR THIS
MEETING.
WE ALSO WANT TO WELCOME THE NIH
RESEARCH AND ADVOCACY COMMUNITY
NEI AND NIH STAFF INCLUDING
STAFF FROM THE CENTER FOR
SCIENTIFIC REVIEW AS WELL AS
MEMBERS OF THE PUBLIC VIEWING
THE MEET ON THE NIH VIDEOCAST.
JUST WANT DO GO OVER SOME NEW
AND USUAL ZOOM MEETING
REMINDERS.
PLEASE IDENTIFY YOURSELF WITH
YOUR FULL NAME EACH TIME YOU
SPEAK SO WE CAN BECOME FAMILIAR.
IF YOU HAVEN'T, INDICATE YOUR
FULL NAME IN THE ZOOM WINDOW TO
CAPTURE ALL THE RECORDS
ACCURATELY AND BE SURE TO
DIRECTLY SPEAK IN THE MICROPHONE
TO HEAR YOU CLEARLY.
SOME ARE A LITTLE BIT FAINT.
I THINK IT WAS CLEAR BUT A
LITTLE BIT FAINT.
NEI STAFF SHOULD HAVE VIDEOS OFF
UNLESS PRESENTING.
AND AS ALWAYS, WE ASK PEOPLE TO
PLEASE MUTE THEMSELVES WHEN NOT
SPEAKING TO ELIMINATE BACKGROUND
NOISE.
IF YOU WANT TO ASK A QUESTION OR
MAKE A COMMENT, PLEASE USE THE
RAISED HAND FUNCTION ON ZOOM AND
REMEMBER TO INTRODUCE YOURSELF.
WE ASK YOU DON'T USE THE CHAT
BOX SINCE PEOPLE ON THE NIH
VIDEOCAST CAN'T SEE THEM AND
THIS IS A PUBLIC SECTION AND IT
WILL BROADCAST LIVE AND WILL BE
ARCHIVED IN PERPETUITY.
AND A SEPARATE INVITATION FOR
THE CLOSED SESSION LATER AND AS
SPECIAL GOVERNMENT EMPLOYEES YOU
MAY NOT ENGAGE IN ANY LOBBYING
ACTIVITIES TODAY WHILE RECEIVING
PAY FROM THE FEDERAL GOVERNMENT.
I USE THAT TERM PAY, LOOSELY.
SO THE DATES FOR THE FUTURE
COUNCIL MEMBERS ARE LISTED ON
THE OPEN SESSION AGENDA AND ON
THE NEI WEBSITE.
I HAVE NOTED THERE'S A CONFLICT
WITH THE OCTOBER 2023 MEETING
AND I'LL WORK TO TRY TO
RESCHEDULE THIS.
OUR NEXT MEETING IS SCHEDULED
FOR FEBRUARY 3, 2023.
AT THIS TIME, WE ARE PLANNING TO
HOLD THAT MEETING IN PERSON IN
BETHESDA BUT THAT IS ALWAYS
SUBJECT TO CONDITIONS ON THE
GROUND DEPENDING ON COVID LEVELS
AND OTHER FACTORS AND NIH
CONTINUES TO CAREFULLY MONITOR
THE SITUATION WITH COVID AND
WILL ADJUST IF NEEDED.
LATIVA WILL FOLLOW-UP ON TRAVEL
AND TRAVEL LOGISTICS FOR THE
FEBRUARY MEETING PROBABLY WITHIN
THE NEXT MONTH TO PLAN
ACCORDINGLY.
ARE THERE ANY QUESTIONS ABOUT
THAT?
OKAY.
ONE MORE THING, WE POSTED THE
MINUTES OF THE LAST MEETING ON
THE ELECTRONIC COUNCIL BOOK.
WOULD ANYONE LIKE TO DISCUSS?
IF NOT, MAY I HAVE A MOTION TO
APPROVE?
THANK YOU.
MAY I HAVE A SECOND?
ALL IN FAVOR OF APPROVING BOTH
THE JUNE AND AUGUST MEETING
MINUTES PLEASE RAISE YOUR HAND.
IS THERE ANYONE OPPOSED?
THANK YOU.
THE MOTION PASSES.
THANK YOU.
I'M NOW GOING TO TURN THE
MEETING BACK TO DR. CHANG FOR
HIS DIRECTOR'S REPORT.
>>THANK YOU FOR DOING THAT.
WE WERE HOPING TO DO THIS IN
PERSON AND IT WASN'T MEANT TO BE
FOR VARIOUS REASONS YOU'RE AWARE
OF BUT HOPING WE CAN DO THAT FOR
THE UPCOMING MEETING.
ANOTHER ISSUE IS THAT WHAT WE'RE
TRYING FOR THIS MEETING AND I
THINK IT CAME ACROSS IN THE
AGENDA AND SOME OF THE
DISCUSSIONS CATHY HAD CIRCULATED
IS THAT WE'RE TRYING TO DO LESS
TALKING AND MORE LISTENING.
IF YOU HAVE COMMENTS, PLEASE
RAISE YOUR HAND OR PRIME UP --
JUST PLEASE RAISE YOUR HANDS AND
WE'LL GET THAT QUEUED UP OR THE
DISCUSSION, AFTER MY REMARKS AND
IN THE DISCUSSION AT THE ENDS OF
THE OPEN SESSION.
SO WE LOOK FORWARD TO THERE WAS
INTERESTING STUFF THAT CAME FROM
THE COMMENTS LAST TIME.
AND THE ONLY OTHER THING I WANT
TO DO IS ACKNOWLEDGE I SEE THAT
WE HAVE TWO REALLY GOOD
SPEAKERS.
RINAD BIEDAS AND JENNIFER SUN.
WELCOME TO BOTH AND WE'LL
INTRODUCE YOU OFFICIALLY WHEN
THE TIME COMES UP BUT WE'RE
REALLY EXCITED ABOUT THAT AND
IT'S SOMETHING THAT CAME UP.
GOOD TO SEE YOU, JENNY.
IT CAME UP AT THE LAST SESSION
AND GOOD TO SEE YOU.
MORE WHEN IT COMES UP.
I'M PROUD TO BE ABLE TO GIVE
THIS DIRECTOR'S REPORT.
ONE THING I'VE BEEN SAYING AT
THE BEGINNING OF ALL THESE TALKS
IS THAT WE'RE TRYING REALLY HARD
TO COMMUNICATE WHAT WE'RE DOING
AT THE NEI WITH THE REST OF THE
WORLD AND IT'S A CHALLENGE AND
WE'VE BEEN TRYING TO USE SOCIAL
MEDIA TO DO THAT AND THESE ARE
THE TWITTER HANDLES AND NEI
DIRECTOR AND NAT INSTITUTE AND
ONE IS THE INSTITUTE'S ACCOUNT.
CONSIDER FOLLOWING THOSE BECAUSE
WE'RE TRYING TO PUT OUT
INFORMATION LIKE WHAT ARE
OPPORTUNITIES COMING UP AND
WHAT'S NEWS FROM THE VISION
COMMUNITY AND MARIA HAS DONE A
GREAT JOB OF MAINTAINING THE NEI
SOCIAL MEDIA PRESENCE.
I'M GOING TO GIVE MY REPORT,
NEWS YOU SHOULD KNOW OF WHAT'S
GOING ON HERE.
ONE OF THEM -- I WANT TO START
WITH MIKE.
ALL OF YOU KNOW MIKE AND THIS
WAS JUST HORRIBLE.
AT TO THE LAST MEETING IN JUNE,
WE HAD ANNOUNCED THAT MIKE HAD
MADE PLANS TO RETIRE IN
SEPTEMBER 30 WAS GOING TO BE HIS
LAST DAY AND HE PASSED AWAY IN A
BOATING ACCIDENT ON JULY 30.
THE COUNCIL ALL KNOWS THIS.
WE HAD CIRCULATED E-MAILS AND WE
HAD A SPECIAL SESSION IN AUGUST
ABOUT THIS AND THIS HAS BEEN
DIFFICULT FOR ALL OF US AT THE
NEI.
I THINK I'D MENTIONED BEFORE
THAT MIKE WAS VERY UNDER STATED.
BEFORE THE JUNE MEETING I TALKED
TO MIKE AND WANTED TO ANNOUNCE
THAT YOU WANT RETIRE IN
SEPTEMBER AND HE SAID WE DON'T
NEED TO DO THAT AND I WAS GLAD
WE DID.
ALL OF YOU KNOW MIKE AND HE'S A
NEUROSCIENTIST BY BACKGROUND AND
WAS THE DIRECTOR OF EXTRAMURAL
ACTIVITIES AND MIKE HAD A LARGER
THAN LIFE FOOTPRINT NOT ONLY
WITHIN NEI BUT NIH OVER ALL.
JUST HAD A BIG ROLE IN THE NEI
AUDACIOUS GOALS INITIATIVE AND
BRINGING NEI WITHIN THE BRAIN
INITIATIVE.
THE MONDAY AFTER WE GOT THE
NEWS, WE HAD A ZOOM MEETING WITH
OVER 100 PEOPLE GET TOGETHER AND
JUST TALK ABOUT MIKE AND A LOT
OF STORIES CAME OUT ABOUT WHAT
INCREDIBLE OF A MENTOR HE WAS.
THERE WERE THINGS HE TAUGHT
THINGS LIKE HOW TO BE CERTIFIED
FOR SCUBA DIVING.
WE GOT TO KNOW MIKE'S WIFE AND
DAUGHTER, SUSAN AND SARAH
THROUGH IT HIT.
THERE'S NOTHING GOOD THAT COMES
OUT OF THIS BUT I WANT TO SAY TO
MIKE WE REALLY MISS YOU AND WITH
THAT, THESE ARE SOME OF THE
UPDATES I WANT TO GIVE.
MIKE WAS THE DIVISION DIRECTOR
OF THE EXTRAMURAL PROGRAMS AND
CATHY, THANK YOU FOR SERVING AS
THE ACTING DIRECTOR OF DESP WITH
YOUR REGULAR JOB AS THE DIRECTOR
OF THE EXTRAMURAL ACTIVITIES.
EVERYONE HERE KNOWS CATHY BUT I
JUST WANT TO MAKE SURE THAT
BEFORE SHE CAME HERE SHE WAS THE
ACTING DIRECTOR IN THIS POSITION
OF EXTRAMURAL SCIENCE PROGRAMS
AT THE NATIONAL INSTITUTE OF
NURSING RESEARCH.
BEFORE THAT SHE WORKED OVER 10
YEARS AT NIMH MENTAL HEALTH
WHERE SHE WAS A DEPUTY DIVISION
DIRECTOR AND MANAGED A LARGE
GRANT PORTFOLIO.
THE OTHER PERSON I WANT TO
HIGHLIGHT IS ANGEETA BHARGAVA
AND HAS BEEN HERE AND BEFORE
COMING HERE SHE HAD WORKED AS A
PROGRAM OFFICIAL IN NIDCR.
SHE MANAGED A PORTFOLIO OF BASIC
AS WELL AS TRANSLATIONAL GRANTS
AND BEFORE THAT SHE HAD
EXPERIENCE AT CENTER FOR
SCIENTIFIC REVIEW.
SO SANGEETA WILL BE TEMPORARY
ACTING DEPUTY DIRECTOR DURING
THIS PERIOD.
I WANT TO GIVE A SHOUT OUT TO
CATHY AND SANGEETA AND WE
PLANNED FOR THIS BUT IT DIDN'T
TRANSITION THE WAY WE PLANNED
BUT THEY'VE BEEN DOING EXTRA
WORK.
LAST I WANT TO GIVE A SHOUT OUT
TO MONIQUE CLARK WHO HAS BEEN
PROMOTED IN THE MANAGEMENT
BRANCH AND HERE'S CATHY AND
SANGEETA AND MONIQUE.
SHE MENTORS NEW SPECIALISTS AND
PROVIDES EXPERTISE ON NEI AND
NIH POLICIES AND PROCEDURES AND
SHE MANAGES A VERY LARGE GRANT
PORTFOLIO.
MONIQUE HAS BEEN IN THE FEDERAL
GOVERNMENT 20 YEARS NOW AND
TAUGHT ELEMENTARY SCHOOL BEFORE
COMING HERE.
CONGRATULATIONS TO MONIQUE AND
INTO THIS NEW POSITION.
I WANT TO GIVE SOME UPDATES
ABOUT NIH AND NEI LEADERSHIP.
ONE THING YOU ALL KNOW IS
ANTHONY FAUCI IS STEPPING DOWN
IN DECEMBER AS MEMBER OF NIAID
AND CHIEF MEDICAL ADVISER TO
PRESIDENT BIDEN.
MARY TABAK DESCRIBED THIS AS THE
END OF AN ERA AND IT'S BEEN 54
YEARS TONY SERVED IN GOVERNMENT
AND HAS BEEN DIRECTOR OF NIAID
FOR 40 YEARS AND HAS DONE A LOT
TO BRING THE COUNTRY THROUGH
DIFFERENT CRISES FROM HIV TO
EBOLA AND COVID.
I HAD A GREAT TIME INTERVIEWING
FOR PART OF A MEETING WE DID.
THIS IS GOING TO BE A BIG
TRANSITION FOR NIH OVER ALL.
WITHIN NEI WE HAVE A COUPLE
SEARCHS.
ONE IS A CLINICAL DIRECTOR
SEARCH IN PROGRESS.
THERE'S A SCIENTIFIC DIRECTOR
SEARCH WHERE SHELDON MILLER
RETIRED AND WE HAVE HAD AN
ACTING DIRECTOR FOR THREE PLUS
YEARS NOW.
DAVID, THANK YOU FOR DOING THAT.
WE'RE IN THE PROCESS OF
INTERVIEWING WITH THIS SO
HOPEFULLY WE'LL MOVE FORWARD
WITH THAT IN THE NOT TOO DISTANT
FUTURE AND LASTLY OUR EXECUTIVE
POSITION OUR CHIEF OPERATING
OFFICER POSITION, THE SEARCH IS
IN ITS FINAL STAGES AND HOPE
WE'LL HAVE SOMETHING TO ANNOUNCE
RELATIVELY SOON.
THERE'S LOTS OF SIGNIFICANT
CHANGES PERSONNEL WISE AND
LEADERSHIP WISE WITHIN THE NEI.
THIS NEXT SET OF SLIDES, WHAT I
WANT TO DO IS GIVE SOME NEWS
ITEMS THAT ARE GOING TO BE OF
INTEREST TO THE VISION
COMMUNITY.
ONE, IS THAT WITHIN OUR
INTRAMURAL RESEARCH PROGRAM
EXCITING FINDING.
THE FIRST PATIENT RECEIVING AN
AUTOLOGOUS TREATMENT FOR DRY EYE
AND THIS WAS THE PRINCIPLE
INVESTIGATOR OF THIS AND THIS
GROUP HAS SPENT 10 TO 15 YEARS
WORKING ON THE TECHNOLOGY THAT
HAS LED TO ALL OF THIS.
IN A NUTSHELL THEY'VE TAKEN
PERIPHERAL BLOOD CELLS AND
ISOLATING INDUCED -- CONVERTING
TO PLURIPOTENT STEM CELLS AND
BACK TO EPITHELIAL CELLS.
THEY BASICALLY GROW CELLS ON A
BIODEGRADABLE PATCH AND LEFT IS
A PICTURE OF THAT AT LOW MEG AND
HIGHER MAGNIFICATION.
IN AUGUST OF THIS YEAR, THIS IS
THE FIRST IN HUMAN SURGERY.
THE FIRST PERSON RECEIVED A
PATCH AT THE NIH CLINICAL CENTER
HERE IN BETHESDA.
IT'S A PHASE 1-2A CLINICAL TRIAL
AND IT WAS DONE BY THE PERSON ON
THE BOTTOM AT THE NEI WE'RE VERY
EXCITED ABOUT THAT.
IT'S AN NEI INTRAMURAL PROJECT
SUPPORTED BY THE NIH COMMON
FOUND.
CONGRATULATIONS TO THE GROUP.
IN REGENERATIVE MEDICINE WE'VE
BEEN EXCITED ABOUT THE 3-D
RETINAL ORGANOID CHALLENGE AND
IT'S GONE THROUGH PHASES AND
WE'VE HAD AWARDS FOR THE FINAL
PHASE DEVELOPING THE RETINA
DISEASE MODELS IN A DISH, IF YOU
WILL,.
AND THESE THE PEOPLE WHO MANAGE
THIS PROCESS.
A MONTH AGO WE ANNOUNCED THE
THREE WINNERS OF PHASE 3.
ONE WAS PICTURED ON THE UPPER
RIGHT FROM THE UNIVERSITY OF
CALENDAR.
VAL AND HER GROUP WERE AWARDED
$5,000 FOR CREATING THE SYSTEM
WITH FUNCTIONAL PHOTO RECEPTORS
AND CELL LAYERS.
WE WERE EXCITED BECAUSE IT'S A
POTENTIAL RESEARCH MODEL FOR AMD
INCLUDING THE RPE CELL LAYER.
PICTURED ON THE MIDDLE RIGHT IS
NATALIA FROM THE UNIVERSITY OF
COLORADO WHO'S GROUP WAS AWARDED
$250,000 FOR A DEVELOPMENT OF A
DIFFERENT ORGANOID MODEL SYSTEM
THAT'S REPRODUCIBLE.
WE WERE EXCITED ABOUT THAT AS A
POTENTIAL MODEL FOR HIGH
THROUGHPUT DRUG SCREENING AND ON
THE BOTTOM RIGHT IS FROM ALBERT
EINSTEIN IN NEW YORK CITY AND
THE GROUP WAS AWARDED $125,000
FOR DEVELOPING A RETINAL
ORGANOID WITH ALL THE MAJOR
NEURON GROUPS IN THE RETINA AND
WA WAS STRIKING WAS THE CONE
RICH AND WE WERE EXCITED IT MAY
BE USEFUL AS A MODEL FOR TESTING
GENE THERAPIES AND AFFECT ON
NEURONAL FUNCTION.
CONGRATULATIONS TO THEM.
WE WERE GRAD TO MOVE THIS
PROCESS.
A LOT OF PEOPLE DID A LOT OF
WORK IN SHEPHERDING THIS.
NEXT I WANT TO TALK ABOUT WORK
IN IMMUNOLOGY.
THROUGH THE AUDACIOUS GOALS
INITIATIVE WE IDENTIFIED SOME
AREAS WE'RE INTERESTED IN MOVING
FORWARD.
ONE INVOLVES TRANSPLANT
IMMUNOLOGY.
THE GAP IN KNOWLEDGE IS FOR
THERAPIES GENE AND CELL-BASED
THERAPIES.
ONE CONCERN THAT'S COME UP
INCREASINGLY IS IMMUNOLOGICAL
GAPS.
WHERE WILL REACTION LIMIT
RESULTS WE'RE GETTING FROM THE
REGENERATIVE MEDICINE
APPROACHES?
WE HELD A WORKSHOP ON THIS IN
JULY 2022 CO-CHAIRED FROM THE
UNIVERSITY OF COLORADO WITH
VICTOR AT DUKE.
VICTOR, THANK YOU AND THIS WENT
WELL.
THERE WERE ALMOST 30 EXPERTS WHO
SPOKE ON THIS AREA AND THERE
WERE QUESTIONS CAN WE MODULATE
SOMEONE'S IMMUNE SYSTEM TO
IMPROVE TRANSPLANT OUTCOMES AND
HOW DO WE OVERCOME BARRIERS TO
INTRODUCE CELL THERAPIES IN INTO
DISEASED EYES.
THE NEXT STEP HERE IS THAT
THERE'S A MEETING SUMMARY BEING
PREPARED AND REVIEWED BY THE
WORKING GROUP WITH NEI
LEADERSHIP.
EXCITED ABOUT THE INITIATIVES
THAT MAY COME OF IT.
I WANT TO TALK ABOUT INITIATIVES
WITH REGENERATIVE MEDICINE.
THE FIRST IS OCULAR SURFACE
INNERVATION AND THE GAPS THESE
PROJECTS WERE INTENDED TO
ADDRESS IS WE DON'T REALLY HAVE
A VERY GOOD UNDERSTANDING OF
OCULAR SURFACE INNERVATION AND
HOW THE PATHWAYS CONTRIBUTE TO
CORNEAL SENSATION, PAIN, DRY A
PAIN, PHOTO PHOBIA, TEARING
REFLEXES.
THERE WERE EIGHT COOPERATE
AWARDS MADE IN THIS AREA.
AND THERE WERE PEOPLE WHO DID
THE BULK OF THE WORK THERE'S A
CONSORTIUM KICK OFF OCTOBER 28.
TWO IS THE SURFACE MICROBIOME
AND WE HAD A WORKSHOP AND WE HAD
PEOPLE WHO WENT FROM GOING TO
THE WORKSHOP TO THE INITIATIVE
AND THE PURPOSE OF THE FUNDING
INITIATIVE IS BASICALLY TO
CREATE A COMMUNITY-BASED
RESOURCE OF MICROBIAL DATA, FOR
EXAMPLE, HOW CAN WE CHARACTERIZE
THE MICROBIOME IN HEALTHY
INDIVIDUALS AND WE'LL REVIEW IT
IN NOVEMBER AND IT WILL GO TO
COUNCIL IN FEBRUARY.
LASTLY, THE BIOLOGY INITIATIVE.
WE'VE BEEN TALKING ABOUT THIS A
FEW YEARS.
THERE'S BEEN A LOT OF PEOPLE WHO
WORKED ON THIS FOR A LONG TIME.
FROM PROGRAMS IT'S PEOPLE LIKE
CHUCK AND GRAY AND NATALIA AND
JENNIFER THAT GOT THIS OUT
THERE.
THE GOAL IS FROM THE STUDY WE
HAVE A RICH DATA SOURCE.
THERE'S OVER 60 PATIENTS
CHARACTERIZED RICHLY FOR RETINAL
MODALITIES AND GENETIC SEQUENCE
DATA AND ALSO PATIENT DERIVED
PLURIPOTENT STEM CELLS FOR
PEOPLE WITH HIGH RISK ALLELES
AND THE PURPOSE IS TO GIVE
ACCESS TO THE DATA AND LEARN
ABOUT THE UNDERLYING
PATHOPHYSIOLOGY OF AMD.
THESE ARE THINGS WE'RE EXCITED
IN NEUROSCIENCE AND NEUROLOGY
AND REGENERATIVE MEDICINE.
ANOTHER THING WE'VE BECOME
INTERESTED IN THROUGH OUR
STRATEGIC PLANNING PROCESS IS
CEREBRAL IMPAIRMENT.
WE HAVE A CHILD WITH THIS WITH A
CARETAKER.
THIS IS SOMETHING AS A PEDIATRIC
OPHTHALMOLOGIST IT'S BECOME THE
LEADING CAUSE OF CHILDHOOD
BLINDNESS IN THIS COUNTRY.
IT'S ASSOCIATED WITH THINGS LIKE
PREMATURITY AND BRAIN DAMAGE AND
THESE PATIENTS HAVE VISUAL
ACUITY DEFICITS AND ONE HALLMARK
IS HIGHER ORDER VISUAL
PROCESSING DEFICITS.
LIKE NOT BEING ABLE TO RECOGNIZE
THINGS WITHIN A CROWDED
BACKGROUND, FOR EXAMPLE.
LOTS OF GAPS IN KNOWLEDGE.
WE NEED A BETTER UNDERSTAND OF
THE NEURAL BASIS AND HOW IT
DIFFERS FROM THINGS LIKE
TRAUMATIC BRAIN INJURY AND
STROKE.
WE NEED BETTER GUIDELINES FOR
DIAGNOSIS AND CLASSIFICATION AND
NEED TO UNDERSTAND THE
REHABILITATION NEEDS OF WHAT WE
CALL BRAIN-BASED VISUAL
IMPAIRMENT OPPOSED TO OCULAR AND
WHAT WE FOUND LEADING UP TO OUR
STRATEGY PLAN WAS THIS REQUIRES
AN INTERDISCIPLINARY APPROACH.
OPHTHALMOLOGIST AND OPTOMETRISTS
WITH IMAGING AND NEUROSCIENCE
AND PHYSICAL AND OCCUPATIONAL
THERAPY AND EDUCATION AND OTHER
FIELD.
OVER THE SUMMER, MANY OF US
ATTENDED TWO CEREBRAL IMPAIRMENT
MEETINGS ONE WAS AT THE PERKINS
SCHOOL FOR THE BLIND AND THE
OTHER WAS IN JULY IN NEBRASKA.
I WAS THERE ALICIA CARE AND DON
AND SHERRY WIGS AND I HOPE I
DIDN'T LEAVE ANYBODY OUT FROM
OUR GROUP THAT ATTENDED.
WE ANNOUNCED WE'D LIKE TO BUILD
A CVI REGISTRY TO HELP SUPPORT
THE COMMUNITY.
THE GOAL IS TO TRACK AND DEVELOP
THINGS LIKE THE CLASSIFICATION
SCREAMS AND TREATMENT METHODS
AND MAY HELP FACILITATE
RECRUITMENT OF PATIENTS TO NEW
STUDIES AND LOOKING AT
REHABILITATION STRATEGIES.
WE'RE TRYING TO WORK WITH THE
COMMUNITY TO ASK THEM WHAT WOULD
BE THE KEY DATA POINTS PEOPLE
WOULD WANT IN THE REGISTRY AND
WE'RE EXCITED ABOUT GETTING THIS
STARTED BECAUSE IT'S A BIG GAP
WE'VE IDENTIFIED AND WE'RE
EXCITED TO WORK WITH THE
COMMUNITY ON THIS.
ANOTHER THING I WANT TO TALK
ABOUT IS MYOPIA IN THE CONTEXT
OF GENE ENVIRONMENT AND
EPIDEMIOLOGY WE LOOKED AT IS
THIS AND THIS PERM PERCOLATED
TO THE TOP AND THE PREVALENCE IS
INCREASING.
WE KNOW FROM WORK IN EAST ASIA
THE ESTIMATES THERE'S AN
ESTIMATE OF 30% TO 40% RANGE AND
SEEMS TO BE GOING UP WITHIN THE
PANDEMIC.
THERE WAS A STUDY PUBLISHED ON
THE BOTTOM RIGHT THERE'S A GRAPH
LOOKING AT RATES OF MYOPIA ON
THE TOP AND HIGH MYOPIA IN THE
BOTTOM AND BY 2050 THERE'LL BE 5
BILLION PEOPLE WITH MYOPIA IN
THE WORLD AND ALMOST 1 BILLION
WITH HIGH MYOPIA.
WHY'S THAT MATTER?
THERE'S CORRELATIONS BY 75, 40%
OF PEOPLE WILL HAVE UNCORRECTED
VISUAL IMPAIRMENT AND MACULAR
DEGENERATION AND WHAT'S KNOWN
AND WHAT'S UNKNOWN GENETIC
STUDIES HAVE SHOWN OVER 200 LOCI
ED BUT THE MECHANISMS OF MACULAR
GROWTH ARE NOT CLEAR.
THIS GENETICS DOES NOT EXPLAIN
THE RAPID RISE IN RATES.
VISUAL EXPERIENCE DRIVES BUT
THERE'S A HOT DEBATE ON WHAT THE
ENVIRONMENTAL MECHANISMS ARE, IS
IT WORK OR SCREEN TIME AND ONE
THING THAT'S HOT NOW IS BROAD
SPECTRUM SUNLIGHT AND LACK OF
SUNSHINE AND THERE'S RESEARCH IN
AREAS LIKE GENETIC AND ANIMAL
MODELS AND EPIDEMIOLOGY BUT THE
FACTORS IN THE STUDIES ARE
SELF-REPORTED.
SOME ARE TOUGH TO QUANTIFY.
THERE'S BEEN A CONVERSATION WITH
THE NATIONAL ACADEMIES OF
SCIENCE, ENGINEERING AND
MEDICINE AND WE'VE DISCUSSED
WITH THEM LAUNCHING A NASEM
STUDY AND WE AGREED TO BE A
MAJOR SPONSOR OF THE STUDIES AND
IT'S GOING LOOK AT BASIS SCIENCE
AND HEALTH DISPARITIES ASPECTS
OF MYOPIA.
IN TERMS OF THE ACADEMIC
DRIVERS, HOW ARE ENVIRONMENTAL
FACTORS RELATED TO THE INCREASE
IN THE MYOPIA FACTORS AND ARE
THERE CHARACTERISTICS OF
ELECTRONIC DEVICES THAT
CONTRIBUTE TO MYOPIA AND HOW DO
WE MAKE THEM SAFER?
WHAT ARE THE RISKS IN CHILDREN
AND THE UNDERLYING CELLULAR AND
MOLECULAR FACTORS THAT CONTROL
GROWTH OF THE EYE?
AND FROM A SOCIO ECONOMIC
PERSPECTIVE WHY ARE THERE SO
MANY PEOPLE WHO HAVE UNCORRECTED
VISION LOSS FROM MYOPIA AND HOW
DO WE IMPROVE ACCESS TO THE
UNDER SERVED POPULATIONS?
SHERRY AND DON EVERETT ARE
INVOLVED AN THERE'S A LARGE
MEETING PLANNED FOR NEXT YEAR.
WE'RE EXCITED ABOUT THIS.
WE TALKED ABOUT COVID TESTING
AND HOW DIFFICULT THEY ARE TO
USE FOR PEOPLE WITH VISUAL
IMPAIRMENT AND NOT BEING ABLE TO
READ THE INSTRUCTIONS OR SEE
THINGS LIKE THE PINK OR BLUE
LINE.
WE START TO WORK AT THE NEI,
WITH THE RAD X-UP GROUP AND
WORKED ON HOW TO MAKE HOME COVID
TESTS MORE ACCESSIBLE TO PEOPLE
WITH VISUAL LOSS AND THE WHITE
HOUSE LAUNCHED AN INITIATIVE
THROUGH ADMINISTRATION FOR
COMMUNITY LIVING ON GETTING
THESE TESTS OUT THERE AS WELL.
MORE ACCESSIBLE TESTS.
AND WE'VE HAD A SERIES OF
MEETINGS WITH THE NATIONAL
INSTITUTE ON MINORITY HEALTH AND
HEALTH DISPARITY.
WHAT WE'RE DOING IS PLANNING A
WORKSHOP THAT'S GOING TO FOCUS
ON A OUM COUPLE DIFFERENT
THINGS.
AN JIMMY IS LEADING IT FROM OUR
END WHO THE INTENT IS IT WILL
FOCUS ON AREAS LIKE ADDRESSING
HEALTH DISPARITIES IN VISION
CARE.
FOR EXAMPLE, UNOPERATED
CATARACTS AND REFRACTIVE ERROR
AND OTHER THINGS LIKE UNTREATED
GLAUCOMA AND DIABETIC
RETINOPATHY AND WHY ARE PEOPLE
LOSING VISION FROM TREATABLE
DISEASE IN 2022?
THAT'S SOMETHING WE'RE LOOKING
FORWARD TO AS WELL.
CARRIE HAS LED OUR OFFICE OF
DATA SCIENCE AND WE HAD A FEW
WORKSHOPS.
ONE INVOLVING OCULAR IMAGING
INTEROPERABILITY.
WHY DON'T THE IMAGING DEVICES
TALK TO EACH OTHER AND TALK TO
ELECTRONIC HEALTH RECORD AND
HELD IT IN CONJUNCTION WITH THE
OFFICE OF NATIONAL COORDINATOR
FOR HEALTH CARE I.T.
WE WERE EXCITED ABOUT THAT.
IT WAS THREE FEDERAL AGENCIES
CO-HOSTING A WORKSHOP AND TRYING
TO WORK TOGETHER TO COME UP WITH
WAYS TO ADVANCE THE FIELD.
IN FOLLOW-UP TO THAT THE
AMERICAN ACADEMY OF
OPHTHALMOLOGY PUBLISHED AN
EDITORIAL ENDORSING WHAT WE'RE
TRYING TO DO AND THAT IS IN
PRESS AND CARRY AND HER GROUP
ARE WORKING WITH A PLANNING
COMMITTEE ON WHAT FOLLOW UP
STEPS WILL BE AND WE'RE EXCITED
ABOUT THIS.
THE OTHER THING I WANT TO
HIGHLIGHT FROM THIS SLIDE IS UP
AT THE TOP, CARRIE AND HER GROUP
HIRED A DATA SCHOLAR AND NIH
DATA AND TECHNICAL SCHOLAR AND
WE'RE EXCITED ABOUT THIS.
MICHELLE AND CARRIE ARE HERE IN
D.C. TOGETHER AT A CONFERENCE
TODAY.
WHAT MICHELLE IS WORKING ON
SPECIFICALLY IS THE BOTTOM LINE
OF THE SLIDE WHICH IS DEVELOPING
A COMMON DATA MODEL FOR EYE CARE
AND FOR VISUAL RESEARCH.
HOW CAN WE DEVELOP A MODEL THAT
WILL HAVE EVERYBODY IN THE
COUNTRY SPEAK THE SAME LANGUAGE
WHEN IT COMES TO REPRESENTING
DATA.
IT'S A HUGE ADVANCE AND IT'S A
COMPLICATED PROJECT.
MICHELLE, CARRIE WITH THE
PLANNING GROUP FROM THE AMERICAN
ACADEMY OF OPHTHALMOLOGY WITH A
GROUP CALLED ODYSSEY ARE WORKING
ON THIS.
THAT'S GOING TO BE BIG FOR THE
COMMUNITY.
AT THE LAST COUNCIL MEETING WE
TALKED ABOUT DATA SHARING AND
MIKE LAUER WAS TALKING ABOUT THE
POLICY.
SINCE THAT TIME THE WHITE HOUSE
OFFICE OF SCIENCE TECHNOLOGY
POLICY HAS PUBLISHED A PUBLIC
ACCESS MEMO ABOUT ACCESS TO
FEDERALLY FUNDED RESEARCH.
I WANT TO HERE SUMMARIZE SOME OF
THAT.
IN 2013 THERE WAS A PUBLIC
ACCESS MEMO AND IN 2022 THE
CURRENT OSTP MEMO APPLIES TO ALL
FEDERAL AGENCIES NOT JUST THE
BIG ONES IN 2013.
IN 2013 THERE WAS A 12-MONTH
PUBLICATION EMBARGO BEFORE YOUR
RESEARCH PAPERS BECAME PUBLICLY
AS ACCESSIBLE AND IN 2022 THEY
HAVE TO BE MADE AVAILABLE
WITHOUT AN EMBARGO PERIOD.
THIS GOES INTO EFFECT IN A FEW
YEARS AND SCIENTIFIC DATA HAS TO
BE ACCESSIBLE AT THE TIME OF
PUBLICATION.
THIS IS A BIG CHANGE.
RIGHT NOW NIH IS WORKING THROUGH
WITH THE WHITE HOUSE TO MAKE
SURE OUR POLICIES ARE
CONSISTENT.
SO THERE'S GOING TO BE MORE
WE'LL ANNOUNCE ABOUT THIS COMING
UP.
ONE OF THE THINGS YOU KNOW ABOUT
IS BRIDGE TO A.I.
THIS IS AN NIH COMMON FUND
PROJECT INVOLVING A.I. IN
BIOMARKER RESEARCH.
THE GOAL AND THIS IS A DIFFERENT
PARADIGM IT'S DATA GENERATION.
$130 MILLION FOR HYPOTHESIS
GENERATING WORK NOT FOR
HYPOTHESIS DRIVEN WORK.
BIG PARADIGM CHANGE.
IT'S BASICALLY GENERATING
DIVERSE DATA SETS ACROSS
DISCIPLINES AND ONE IS
INTEGRATING EDGE NICKS COMPONENT
TO REDUCE BIAS IN GENERATING THE
DATA SETS AND THE A.I. THAT
COMES OUT OF IT.
HERE'S THE BRIDGE TO A.I. LOGO
AND THE BOTTOM IS THE PROGRAM
OFFICER.
WE'RE ONE OF FIVE INSTITUTES
THAT LEAD THE BRIDGE TO A.I.
PROJECT.
ABOUT A MONTH AGO THERE WERE
FOUR AWARDS MADE AND THE BRIDGE
FUNDED TO INTEGRATE ALL THE
PROJECTS.
ONE OF THE PROJECTS WAS GIVEN TO
UNIVERSITY OF SOUTH FLORIDA FOR
THE DATA SET OF VOICE AND HOW DO
YOU DIAGNOSE DISEASE WITH
PEOPLE'S VOICES AND HOW DOES
THAT CONNECT WITH MENTAL HEALTH
CONDITIONS AND AWARD TWO OF FOUR
WAS TO U.C. SAN DIEGO FOR
BASICALLY GENERATE DATA SET OF
CELL ARCHITECTURE COMBINED
PROTEOMIC AND GENOMIC AND
CELLULAR IMAGING DATA TO LOOK AT
GENE PATHWAYS AND NETWORKS THAT
RELATE TO DISEASE.
AWARD NUMBER THREE WENT TO
MASSACHUSETTS GENERAL HOSPITAL
AND THAT WAS BASICALLY BUILDING
A DATA SET OF PACING DATA FROM
ADULT AND PEDIATRIC ICUs TO
DEVELOP A.I. TECHNOLOGY TO HELP
PEOPLE RECOVER FROM ACUTE
ILLNESS.
AND AWARD NUMBER 4 WAS TO
UNIVERSITY OF WASHINGTON.
THIS WAS LED BY TWO
OPHTHALMOLOGISTS.
ON THE RIGHT IS AND OBVIOUSLY
THIS IS SOMETHING WE WERE
EXCITED ABOUT.
THE TOPIC HERE IS DIABETES.
AND THEY'RE BASICALLY RECRUITING
DATA FROM 4,000 PEOPLE WITH
VARIOUS LEVELS OF TYPE 2
DIABETES.
THIS HAS ALL THE CLINICAL AND
IMAGE DATA YOU'D EXPECT PERFECT
BUILDING A DIABETES DATA SET AND
ALSO INCLUDES THINGS LIKE
CONTINUOUS GLUCOSE MONITORING,
FIT BIT TRACKING AND
ENVIRONMENTAL SENSORS LOOKING AT
THINGS LIKE POLLUTANTS.
THESE ARE NOT THINGS AVAILABLE
IN TRADITIONAL DATA SETS AND
WE'RE EXCITED HOW WE MAY GET A
MORE WHOLISTIC OF PICTURE OF
PEOPLE WHEN THEY'RE NOT IN THE
HOSPITAL LET ALONE WHEN THEY
HAVE DIABETES.
EXCITED ABOUT THIS WHAT I CALL
A.I. FRIENDLY HYPOTHESIS
AGNOSTIC DATA SET INVOLVING
DIABETES AND LED BY TWO
OPHTHALMOLOGISTS.
LAST SLIDE, EYE ON THE FUTURE.
THEY SPENT SIX MONTHS PLANNING
THIS EVENT.
IT WAS A VIDEO CONTEST FOR HIGH
SCHOOL STUDENTS TO MAKE VIDEOS
WHAT THEY'RE INTEREST ABOUT IN
SCIENCE AND WE'RE TRYING TO GET
YOUNG KIDS ESPECIALLY FROM UNDER
REPRESENTED GROUPS INTERESTED IN
SCIENCE.
WE HAD 10 TEENAGERS VISIT THE
NIH AND MARIE BERNARD IS CHIEF
OFFICER FOR SCIENTIFIC WORKFORCE
AT NIH AND HAD TWO VISITING
FACULTY MATTERS WHO SPOKE ONE
FROM YALE AND ONE FROM THE
UNIVERSITY OF MICHIGAN AND WHAT
I WAS EXCITED ABOUT PARTICULARLY
HAVING TWO DAUGHTERS, EVERY ONE
WE HAD VISIT WAS FEMALE.
SO WE'RE EXCITED.
THEY DID A GOOD JOB OF
ORGANIZING THIS AND EXCITED
ABOUT DOING IT AGAIN NEXT YEAR.
WITH THAT --
>>CAN I INTERRUPT YOU FOR ONE
SECOND.
SORRY, I HATE TO DO THIS.
CAN WE SAVE THE BUDGET UPDATE
FOR AFTER THE SPEAKER SESSION.
IF IT'S OKAY WITH KAREN, WE HAVE
MORE FLEXIBILITY LATER IN THE
MORNING.
>>YES, ABSOLUTELY.
>>AND WE HAVE TIME LATER FOR A
GENERAL DISCUSSION.
WE CAN PROBABLY TAKE ONE OR TWO
QUESTIONS NOW AND THEN I'LL TURN
IT BACK TO DR. CHIANG TO
INTRODUCE OUR SPEAKERS.
>>HOW DO WE LEARN ABOUT THE EYE
ON THE FUTURE THE ONE FOR NEXT
YEAR IF WE HAVE INTERESTED HIGH
SCHOOL STUDENTS THAT MAY BE
WORKING IN OUR LAB?
>>WE'LL DO OUR BEST TO PUSH IT
OUT.
WIN THING WE TRIED TO DO IS USE
SOCIAL MEDIA TO DO THAT.
MAYBE WE CAN BLAST OUT TO
COUNCIL MEMBERS BUT LOVE IF YOU
CAN HELP PUBLICIZE THAT BECAUSE
IT WAS MEANT TO BE A NATIONAL
CONTEST AND HAD PEOPLE FROM A
TON OF STATES APPLY.
THANK YOU AND I APPRECIATE YOUR
HELP IN PUBLICIZING THIS.
OTHER COMMENTS OR QUESTIONS
PEOPLE HAVE ABOUT ANY OF THIS?
CATHY, WOULD YOU LIKE TO START
WITH RINAD AND JENNY SPEAKING?
>>I WOULD LOVE THAT.
>>THIS MEANS I'LL RESHARE MY
SCREEN.
LET ME INTRODUCE -- YOU'RE GOING
TO GO FIRST.
LET ME INTRODUCE YOU RIGHT NOW
AND I'LL INTRODUCE JENNY BEFORE
SHE SPEAKS.
THE TOPIC IS PROMOTING
DISSEMINATION OF CLINIC RESEARCH
AND THE ORIGIN AND THIS IS AN
AGE OLD CHALLENGE WE HAVE.
AT THE LAST COUNCIL MEMBER WE
HAD A COUPLE PEOPLE COUNCIL
MEMBERS RAISE THE QUESTION OF
WHAT IS THE BEST WAY TO -- WHY
DO WE HAVE THIS GAP UP TERMS OF
CLINICIANS NOT BEING ABLE OR
KNOWING ABOUT THE SOME OF THE
FINDINGS THAT COME OUT.
SO WE TALKED ABOUT THIS AT
LENGTH AND WE HAD SOME MEETINGS
WITHIN NEI ABOUT THIS.
WE LIKE TO CREATE A COUNCIL WORK
GROUP ON THIS BUT THOUGHT THE
BEST WAY TO KICK THIS OFF WOULD
BE TO HAVE A SPECIAL SESSION ON
THE TOPIC.
AND ONE OF THE THINGS I WAS
EXCITED ABOUT WAS LEARNING ABOUT
WORK THAT RINAD HAD DONE IN THIS
AREA.
WE HAD A CHAIR AT NORTHWESTERN
UNIVERSITY JUST MOVE THERE FROM
THE UNIVERSITY OF PENNSYLVANIA
WHERE SHE WAS FOUNDING DIRECTOR
OF THE IMPLEMENTATION SCIENCE
CENTER AT THE LEONARD DAVIS
INSTITUTE AND DOES SOME
INTERESTING RESEARCH INVOLVING
IMPLEMENTATION SCIENCE AND
BEHAVIORAL ECONOMICS TO
BASICALLY TRY TO GET
ORGANIZATIONS TO USE BEST
PRACTICES TO USE EQUITY OF CARE
AND HEALTH OUTCOMES.
>>CAN YOU ALL HEAR ME ALL
RIGHT?
I CALLED IN TO MAKE SURE THERE
WAS NO PROBLEM.
ARE YOU SEEING THE PRESENTER
VIEW?
>>THIS IS THE CORRECT VIEW.
AND AM I ON DELAY OR DOES
EVERYTHING SEEM GOOD?
>>WE'RE GOOD.
I'M GOING TO GO AHEAD AND JUMP
IN.
IF ANYTHING IS AWRY FEEL FREE TO
SIGNAL VISUALLY SINCE I'LL HAVE
THIS BELOW TO SEE WHAT IS
HAPPENING.
I WANT TO START BY THANKING THE
NATIONAL EYE INSTITUTE AND MIKE
FOR THE INVITATION TO COME SPEAK
TODAY.
I'M EXCITED TO BE PRESENTING
ALONG SIDE JOANIE AND I ALSO
WANT TO THANK MY PARTNER AND
COLLEAGUE FROM PENN MEDICINE
DR. LANGFALL WHO WE
COLLABORATIVELY DEVELOPED THE
SLIDES IN VARIOUS PRESENTATIONS.
I WANT TO ACKNOWLEDGE HER
INTELLECTUAL CONTRIBUTIONS HERE.
ALSO THE IMPLEMENTATION SCIENCE
AND PRACTICE COMMUNITY AND ALL
FOR YOUR ATTENTION AND
ENGAGEMENT.
I KNOW IT'S DIFFICULT TO ATTEND
VIRTUALLY FOR LONG PERIODS SO
I'LL TRY TO BE ANIMATED AND
ENTHUSIASTIC AND TRY TO KEEP
YOUR ATTENTION DURING THE TIME
WE HAVE TOGETHER.
TO ORIENT YOU TO WHAT I HOPE
WE'LL HAVE TIME TO TALK ABOUT
TODAY I CAN THINK OF THE
STRUCTURE IN FOUR CHAPTERS.
I'LL START BY TALKING ABOUT ME
AS AN INVESTIGATOR AND HUMAN AND
WHY I THINK THIS IS A REALLY
IMPORTANT AREA TO ATTEND TO AND
I'M GLAD TOE HEAR COUNCIL
MEMBERS SUGGESTED THE EYE
INSTITUTE PAY ATTENTION TO THIS
SCIENCE AND LEVEL SETTING OFFER
WHAT IMPLEMENTATION SCIENCE IS
AND SHARE INFORMATION WITH YOU
AS YOU MOVE FORWARD AND THINK OF
HOW TO INCORPORATE IMPLEM
IMPLEMENTATION SCIENCE IN YOUR
PORTFOLIO AND SHARE APPLICATIONS
IN THIS SPACE IN YOUR CONTENT
AREA.
FIRST, I WANT TO TELL YOU A
LITTLE BIT ABOUT ME.
MY IDENTITY SHAPED MY
PERSPECTIVE AND IT'S IMPORTANT
IT KNOW WHO I AM AND WHAT
IDENTITIES I BRING.
I IDENTIFY AS AN IMPLEMENTATION
SCIENCE -- SCIENTIST I WORK TO
MAKE IT EASIER FOR STAFF,
CLINICIANS, LEADERS AND
ORGANIZATIONS TO USE BEST
PRACTICES WITH THE END GOAL OF
IMPROVING THE QUALITY AND EQUITY
OF HEALTH OUTCOMES AND I'M A
MIDDLE EASTERN IMMIGRANT AND
MOTHER AND UP TO RECENTLY A
PRACTICING PSYCHOLOGIST IN
PEDIATRIC ANXIETY.
ALL THESE INFLUENCED MY
PERSPECTIVE AND I SEE
IMPLEMENTATION SCIENCE AS THE
WAY TO AMPLIFY THE NEEDS FOR
COMMUNITIES IN ACHIEVING POM
POPULATION HEALTH AND SOCIAL
JUSTICE AT SCALE.
I ALSO WANT TO IS A WHAT I'M
NOT.
I HAVE NO CONTENT EXPERTISE IN
VISION RESEARCH BUT I WANT TO
SAY EVERYTHING I TALK ABOUT WILL
BE APPLICABLE TO THE RESEARCH
AND I OFTEN GIVE PRESENTATIONS
IN MEETINGS WHERE I DON'T HAVE
CONTENT EXPERTISE BUT THE SAME
CHALLENGES ACROSS HEALTH CARE
ARE APPARENT IN AREAS AND
DRIVING IMPLEMENTATION ACROSS
CONTENT.
I DO THIS IN MENTAL HEALTH,
CANCER, HIV, CARDIOVASCULAR
DISEASE AND PEDIATRIC HOSPITAL
MEDICINE.
I'M CONTENT AGNOSTIC.
THE REASON I'M HERE IS BECAUSE I
SAW A PATTERN WHEN I WAS
PRACTICING CLINICALLY I COULDN'T
IGNORE.
WE'LL SHARE THE STORY OF A
60-YEAR-OLD FEMALE WHO SAW ME
WITH SEVERE ANXIETY WHO WASN'T
ABLE TO GO TO SCHOOL OR DO THE
THINGS A 16-YEAR-OLD WOULD LIKE
TO DO.
AN IMPORTANT PART OF THE STORY
IS JEN HAD SEEN A NUMBER OF
PROVIDERS AND HADN'T GOTTEN THE
GOLD STANDARD COGNITIVE
BEHAVIORAL THERAPY FOR THIS AND
BY THE TIME SHE GOT TO ME SHE
WAS FAIRLY UP SET AND YOU SAW
WHAT SHE WAS ABLE TO DO
INCLUDING RETURNING TO SCHOOL
AND SINGING IN THE CHOIR, GOING
TO THE DENTIST.
I CAME TO THE CONCLUSION THAT
YOUNG PEOPLE WEREN'T RECEIVING
EVIDENCE-BASED PRACTICES IN THE
COMMUNITY AND IT WENT FROM
FOCUSSING ON DEVELOPING NEW
TREATMENTS TO THINKING HOW TO
DEPLOY THE AFFECTIVE TREATMENTS
WE HAVE.
MY OBSERVATION AS A PSYCHOLOGIST
IS NOT IDIOSYNCRATIC.
IT'S A BROADER FIELD AND ISSUE
WE'RE AWARE OF.
THE PROBLEM HAS NEVER BEEN MORE
CLEAR WHEN WE LOOK AT THE
EXAMPLE OF COVID-19.
THERE'S A SCREEN SHOT OF A PAPER
THAT WAS A HEALTH AFFAIRS BEST
PAPER IN 2020 AND SIMULATION
STUDY LOOKING AT THE OUTCOMES OF
HYPOTHETICAL COVID-19 VACCINE
AND THE IMPLEMENTATION WOULD BE
MORE IMPORTANT THAT BE THE
EFFICACY OF THE VACCINE ON THE
IMPACT ON CLINIC OUTCOMES AND
PLAYED OUT IN MITIGATION
STRATEGIES AND IN ANTIVIRALS.
THIS PAPER CAME OUT IN 2021 AND
LED BY MY COLLEAGUES AT WASH-U
AND CALLED OUT COVID-19 AND
KNOWING WHAT TO DO DIDN'T ENSURE
DOING WHAT WE KNOW.
THAT'S THE CRUX OF WHY
IMPLEMENTATION SCIENCE MATTERS.
SO MY VISION STATEMENT AND
BELIEF AND THE REASON I GET UP
IS IT CAN ACHIEVE THE PROMISE OF
SCIENTIFIC DISCOVERY AND ACHIEVE
IMPACT AT SCALE.
WHAT I HOPE IS THAT YOU LISTEN
CLOSELY AND THINK ABOUT HOW THIS
DISCIPLINE MIGHT ADVANCE THE
NATIONAL EYE INSTITUTE AND
IMPROVE QUALITY OF LIFE THROUGH
VISION RESEARCH.
THINK YOU'LL BE ABLE TO LEARN
ACROSS THE AREAS I'LL BE TALKING
AND HOPE YOU KEEP THAT IN MIND
AND FRONT AND CENTER AND I ALSO
WANT TO CALL OUT IN THE
PORTFOLIO ANALYSIS DONE THERE'S
A PAPER BY THE NATIONAL CANCER
INSTITUTE LOOKING AT HOW MUCH OF
THE PORTFOLIO IS DEDICATED TO
DISCOVERY VERSUS IMPLEMENTATION
RESEARCH.
AND NCI HAS BEEN PUSHING THE
ENVELOPE ON DOING THIS KIND OF
WORK AND THEY'VE BEEN A REAL
LEADER WITHIN THE NATIONAL
INSTITUTE OF HEALTH WITH LDI AND
NIMH.
IT'S SUCH A MINUSCULE AMOUNT OF
THE BUDGET GOES TOWARDS ACTUALLY
IMPLEMENTING OUR DISCOVERY.
IT'S AMAZING THERE'S SOO -- SO
MANY DISCOVERIES TO HELP PEOPLE
BUT WE HAVE TO PAY ATTENTION OF
AND HAVE TO DO THE WORK WITH THE
RIGOR AS DISCOVERY RESEARCH.
NOW I'LL TALK ABOUT
IMPLEMENTATION SCIENCE IS
BROADLY.
ON THIS SLIDE YOU CAN SEE MY
PERSONAL DEFINITION WHEN I TALK
ABOUT WHAT DO I IS FUNDAMENTALLY
MAKING SURE THAT ALL PEOPLE GET
THE THINGS THAT WORK IN THE
COMMUNITY OR WHATEVER SETTING IN
WHICH THEY'RE ARRIVING TOWARDS
RECEIVING CARE AND MOVING THE
NEEDLE EQUITABLY IN HEALTH.
IT'S ABOUT MOVING THE NEEDLE.
THE NCI DEFINITION AS YOU THINK
ABOUT WA I'M SHARING WITH YOU
ALL, THE NCI DEFINITION IS
IMPLEMENTATION SCIENCE IS THE
STUDY OF METHOD TO PROMOTE THE
ADOPTION AND INTEGRATION OF
EVIDENCE-BASED PRACTICES,
INTERVENTIONS INTO ROUTINE
HEALTH CARE AND SETTINGS WITH
THE END GOAL OF IMPROVING
POPULATION HEALTH.
YOU CAN SEE HERE THERE'S
MULTIPLE TYPES OF THINGS WE MAY
WANT TO BE DEPLOYING INCLUDING
PROCEDURES, PROGRAMS, PRODUCTS.
IT'S NOT SO SIMPLE THERE'S JUST
ONE THING WE WANT TO IMPLEMENT.
THERE'S A FLEET OF APPROACHES
AND MY UNDERSTANDING IS THAT
IT'S HELPFUL TO OUTLINE THE
ASSUMPTIONS OF THE FIELD FOR
FOLKS WHO MAY NOT BE AS FAMILIAR
WITH IT AND IT'S HELPFUL AS A
FIELD TO LEVEL SET AT AS THE
FIELD GROWS.
THE WORK MUST BE DONE IN
PARTNERSHIP WITH THE COMMUNITY.
THE WORK MUST BE DONE IN
PARTNERSHIP WITH OUR
COMMUNITIES.
THIS IS MESSY WORK AND IT'S IN
THE REAL WORLD AND WHEN I TALK
ABOUT THE OPPORTUNITIES WITHIN
THE NATIONAL EYE INSTITUTE AND
ASKING STAKEHOLDERS OR PARTNERS
WHAT THEY WANT TO SEE IN
REGISTRY.
AND A GREAT EXAMPLE OF
PARTNERING TO UNDERSTAND HOW OUR
SCIENCE CAN BE ACTIONABLE AND
USEFUL.
THAT'S AN IMPORTANT THING TO
KEEP IN MIND.
OUTCOMES MAY BE MORE FAMILIAR
AND WE LOOK AT BEHAVIOR WITHIN
ORGANIZATIONAL CONSTRAINTS.
AND WHEN WE THINK ABOUT WHAT WE
TARGET WITH OUR STRATEGIES AND
APPROACHES IT'S TYPICALLY
FOCUSSED ON CHANGING CLINICIANS'
BROADLY SPEAKING BEHALF WITHIN
THE CONSTRAINTS OF THE
ORGANIZATIONS THEY WORK WITHIN.
THIRD, WHEN WE DO MULTI-SITE
STUDIES WE TRY TO REDUCE THE
NOISE AND ISOLATE THE EFFECT OF
A PARTICULAR INTERVENTION OR
PROCEDURE.
WE WANT TO UNDERSTAND THAT
CONTEXT AND HOW IT RELATES TO
IMPLEMENTATION SUCCESS AND
FAILURE.
THAT'S A BED ROCK OF THE WORK WE
DO FOURTH, WE'D LIKE TO SEE AN
EVIDENCE-BASED END AND THERE'S
ROOM AND I RECOMMEND WE
INCORPORATE THESE PRINCIPLES
SOONER THAN WHEN WE GET TO THE
POINT OF HAVING AN
EVIDENCE-BASED THING BUT WHEN
WE'RE SPENDING A LOT OF MONEY TO
DEPLOY THINGS WE WANT THEM TO BE
EVIDENCE BASED.
FINALLY, WE HAVE A ROBUST AND
SPECIFIC SET OF FRAME WORKS,
METHODS AND STRATEGIES.
I ENCOURAGE YOU ALL TO DRAW FROM
THE EXISTING INFRASTRUCTURE WE
HAVE AS A FIELD.
I KEY RE-INVENTIONING OF THE
WHEEL AND THERE'S THINGS WE CAN
DRAW UPON.
TO SAY SIMPLY, I LEARNED FROM MY
COLLEAGUE WHO PUBLISHED THIS
PIECE IN IMPLEMENTATION SCIENCE
COMMUNICATION, THINK ABOUT THE
THING WHICH IS, WHEN I SAY
THING, THE INTERVENTION,
PROCEDURE, APPROACH WE'RE TRYING
TO DEPLOY IN A NEW SETTING.
AND THE IMPLEMENTATION IS ON HOW
TO HELP PEOPLE AND PLACES DO THE
THINGS.
I FOUND OUT HELPFUL TO LOOK AT
THE STRATEGIES AND WHAT WE USE
TO DEPLOY AND WE SAY
IMPLEMENTATION STRATEGIES TO
REALLY CARVE OUT WHAT WE'RE
TRYING TO DO HERE SCIENTIFICALLY
AND I'LL GIVE LOTS MORE EXAMPLES
THROUGH THE COURSE OF THE TALK
ABOUT WHAT I MEAN FWHA.
--
WHAT I MEAN BY THAT.
FINALLY, BEFORE I GET IN THE
SPECIFIC TOOLS I'D LIKE TO SHARE
THE TOOL I DEVELOPED WITH MY
COLLEAGUES AFTER TEACHING
IMPLEMENTATION SCIENCE FOR YEARS
AND IT'S IMPERFECT BUT HELPS
PEOPLE THINK WHERE THEIR WORK
FITS ON THE IMPLEMENTATION
SCIENCE AND I'LL WALK YOU
THROUGH EACH STEP TO UNDERSTAND
THE SUBWAY.
THE FIRST PLACE WE OFTEN JOIN
THE SUBWAY IS IDENTIFYING A
PRACTICE THE FIRST QUESTION YOU
MAY ASK YOURSELF IS HAS THAT
THING SHOWN EFFICACY?
NOT EVERYTHING IS GOING TO BE
TESTED IN AN EFFICACY
TIGHTLY-CONTROLLED LABORATORY
SETTING BUT MANY THINGS ARE.
THAT'S WHEN WE'RE REALLY
EVALUATING INTERNAL VALIDITY
VERSUS EXTERNAL AND THERE'S
EXCLUSION CRITERIA AND IF THE
ANSWER IS NO, THAT THING HAS NOT
HAD EFFICACY AND TYPICALLY
EFFICACY RESEARCH AND TESTING IN
IN A TIGHTLY CONTROLLED SETTING
TO UNDERSTAND AND YOU CAN DESIGN
FOR IMPLEMENTATION HERE AND ONE
KEY TO LEARNING OVER THE PAST 20
YEARS IS THAT WE WERE
INCORPORATED STAKEHOLDER
PARTNERS IN THE PROCESS OF WHAT
WE'RE DESIGNING TO UNDERSTAND
IT'S ACCEPTABLE, APPROPRIATE,
PALATABLE AND CAN BE DEPLOYED IN
A REAL WORLD CLINICAL SETTING.
THAT NOT ITSELF IS THE SUBWAY
LINE.
IT'S A PARTICULAR TYPE OF WORK
AROUND INTERVENTION OR THING
DEVELOPMENT THAT CAN INCORPORATE
THAT LENS.
IF THE ANSWER IS YES AND THE
NEXT SET OF QUESTIONS IS WHETHER
OR NOT THAT THING HAS SHOWN
EFFECTIVENESS.
HAS IT BEEN DELIVERED IN A REAL
WORLD SETTING AND HAVE WE LOOKED
AT IMPACTING EXTERNAL OUTCOMES?
I WOULD ARGUE MUCH OF THE TIME
IN INTERVENTION DEVELOPMENT WE
SHOULD BE TESTING INTERVENTIONS
IN THE SETTINGS IN WHICH THEY
WERE INTENDED TO BE DEPLOYED.
THAT'S THE TRUE TEST OF THE
THING.
THAT'S THE CONVERSATION WE CAN
HAVE ANOTHER TIME.
AND IF YOUR TESTING IT IT'S NOT
IMPLEMENTATION RESEARCH IF
YOU'RE ONLY FOCUSSED ON THE
VISION CLINICAL OUTCOME.
THAT'S A COMMON SET POINT.
HOWEVER, IF YOU START TO BRING
THEM ALONGSIDE PATIENT OUTCOMES
INCLUDING HOW WELL THE THING WAS
DEPLOYED OR FACIL ITATORS THAT S
WHAT WE CALL HYBRID TRIALS AND
YOU LOOK AT PATIENT AND CLINICAL
OUTCOMES SIDE BY SIDE AT THE
IMPLEMENTATION PROCESSES.
THAT'S ON THE GREEN LINE OF WHAT
WE DO IN THE IMPLEMENTATION
SCIENCE PHASE.
FINALLY, YOU'LL SEE THE BOTTOM
OF THE GREEN LINE THE BREAD AND
BUTTER OF THE WORK WE'LL DO AND
OFFER TWO EXAMPLES THAT WILL
BRING THIS TO LIGHT FOR YOU AND
THAT INCLUDES MIXED METHODS
STUDIES TO UNDERSTAND THE
CONTEXT IN WHICH WE'RE HOPING TO
DEPLOY AND DESIGNING THE
STRATEGIES THAT WE WANT TO
DEPLOY BASED ON WHAT WE
UNDERSTAND TO BE THE BARRIERS
AND FACILITATORS AND
IMPLEMENTATION AND TESTING
IMPLEMENTATION ATTORNEY GENERALS
IN LARGE COMPARATIVE
EFFECTIVENESS STUDIES OF OUR
IMPLEMENTATION STRATEGIES.
WE'RE UP A LEVEL WE'RE LESS
INTERESTED IN ASKING DOES IT
WORK FOR A PATIENT POPULATION
AND MORE INTERESTED IN DOING
WHAT WE DO TO HELP PEOPLE DO THE
THINGS RESULTING IN BETTER
IMPLEMENTATION AND UPTAKE AND
LOOK AT BETTER OUTCOMES
ALONGSIDE THAT.
HOPEFULLY THAT HELPS YOU
UNDERSTAND WHERE IN THE RESEARCH
PARADIGM IMPLEMENTATION SCIENCE
FOCUSES.
NOW I'LL GO DEEPER IN THE FIELD
WITH OUR NEXT CHAPTER WHICH IS
TO FOCUS ON FOUNDATIONAL
CONCEPTS I THINK WILL BE
VALUABLE FOR YOU ALL TO HAVE AND
A VISION FOR WHAT IMPLEMENTATION
RESEARCH CAN LOOK LIKE AT THE
NATIONAL EYE INSTITUTE.
I WANT TO DRAW YOUR ATTENTION TO
A PAPER WRITTEN BY COLLEAGUES
THAT OUTLINES 10 CRUCIAL
INGREDIENTS OF GRANT ROW
PROPOSALS.
THEY EXTRACTED WHAT THEY THOUGHT
WOULD BE KEY IN PROVIDING THING
ASSISTANCE AND I WANT TO ARGUE
THESE ARE 10 CRUCIAL INGREDIENTS
AND HOW WE CONDUCT OUR WORK.
BECAUSE WE HAVE LIMITED TIME I
CAN'T FOCUS ON ALL 10 BUT THE
PAPER IS AN EXCELLENT READ.
I'LL FOCUS ON THE THREE I THINK
ARE MOST SALIENT FOR YOU ALL
INCLUDING THE CONCEPTUAL MODELS
WE USE TO GUIDE OUR WORK,
IMPLEMENTATION STRATEGIES WHICH
ARE OUR INTERVENTIONS HOW WE
LOOK AT BEHAVIOR WITHIN AGE
ORGANIZATIONAL CONSTRAINT AND
THOUGHTFUL APPROACHES IN
ANALYSIS IN OUR STUDY DESIGN.
I'LL TALK WITH ABOUT THE
THEORIES IN THE FIELD OF
IMPLEMENTATION SCIENCE.
I'D LIKE TO OFFER STORAGE BOX
CREDITED FOR SAYING ALL MODELS
ARE WRONG BUT USEFUL IN HELPING
GUIDE OUR THINKING.
IF YOU KNOW THE EXACT QUOTE POP
IT IN THE CHAT AND I'LL SAY IT
CORRECTLY.
I LIKE TO APPROACH MY THINKING
AROUND FRAMEWORK WITH HUMILITY
AND I'M NOT BEING DOGMATIC ABOUT
IT BUT USING IT TO GUIDE OUR
THINKING BUT UNDERSTANDING
THEY'RE ALL WRONG AND IT'S
USEFUL FRAMEWORK AND IF YOU GO
TO THE LITERATURE, THESE ARE
HELPFUL ONES.
THE FIRST WAS FOCUSSED ON RING
THE EXISTING FRAMEWORKS AND
MODELS IN THE FIELD.
WE HAD OVER 151 AND CAN FEEL
OVERWHELMING AND TO HOW WE THINK
BIT TO HOW WE MAKE IT LESS
OVERWHELMING AND THAT COMES IN
THE FORM OF THE NELSON PAPER
WHICH WAS PUBLISHED IN
IMPLEMENTATION SCIENCE IN 2015
CALLED MAKING SENSE OF
IMPLEMENTATION SCIENCE MODELS
AND FRAMEWORK.
IN THE NEXT SLIDE YOU'LL SEE A
CORE FIGURE FROM THAT PAPER AND
I'LL WALK YOU THROUGH IT.
AND SO NELSON MAKES THE ARGUMENT
IN THE 151 PLUS THEORIES AND
MODELS IN THE FIELD, THEY
ROUGHLY BREAK DOWN INTO THREE
LARGE BUCKETS.
ONES THAT ARE LARGELY
PRESCRIPTIVE OR GUIDE THE
PROCESS OF TRANSLATING RESEARCH
INTO PRACTICE AND ONES THAT ARE
FOCUSSED ON DESCRIBING OR
UNDERSTANDING WHAT INFLUENCES
IMPLEMENTATION OUTCOMES AND THE
THIRD BUCKET IS ONES FOCUSSED ON
HOW WE EVALUATE OUR
IMPLEMENTATION OUTCOMES EFFORTS.
AND SO JUST TO GIVE YOU A FLAVOR
FOR SOME OF THE EXAMPLES FROM
THESE BUCKETS, OFTEN WE SEE
PROCESS MODELS MAPPING ON TO THE
KIND OF DESCRIPTIVE OR PROCESS
GUIDING APPROACHES AND THOSE
INCLUDE THINGS LIKE THE
KNOWLEDGE TO ACTION FRAMEWORK
OUT OF CANADA OR THE QUALITY
IMPROVEMENT MODEL FOR
IMPROVEMENT.
STEP 1, ENGAGE STAKEHOLDERS.
STEP 2, IDENTIFY YOUR
EVIDENCE-BASED PRACTICES AND
STEP 3 AND IT WALKS YOU THROUGH
THE PROCESS.
THANK YOU TO MAUREEN FOR THE BOX
QUOTE, ALL MODELS ARE WRONG BUT
SOME ARE USEFUL.
THAT'S THE FIRST BUCKET IN OUR
LARGE OF IMPLEMENTATION SCIENCE
FRAMEWORK.
THE SECOND BUCKET ARE THE
UNDERSTANDING OR EXPLANATORY
TYPE FRAMEWORKS AND THERE'S
THREE THAT FOLLOW IN THAT
BUCKET.
THE FIRST IS PROBABLY THE MOST
POPULAR OR AMPLIFIED I SEE IN
ALL GRANT APPLICATIONS IN ALL
WORK WHICH IS SOMETHING WE CALL
DETERMINATE FRAMEWORKS.
THEY'RE LARGELY LISTS MUCH
VARIABLES AT MULTIPLE ECOLOGICAL
DOMAINS THAT DESCRIBE CHALLENGES
AND BARRIERS AND FACILITATORS.
AT THE PATIENT LEVEL AND
CLINICIAN LEVEL AND ORGANIZATION
LEVEL AND SYSTEM LEVEL AND THESE
INCLUDE FRAMEWORKS SUCH AS
EXPLORATION, PREPARATION AND
IMPLEMENTATION RESEARCH AND
INCLUDING THE HEALTH EQUITY
FRAMEWORK BUT THAT INCORPORATES
THE STRUCTURAL AND HEALTH EQUITY
FACING NATURE.
WITHIN THE BUCKET OF
UNDERSTANDING OUR EXPLANATORY
FRAMEWORK WE HAVE CLASSIC
THEORIES LIKE THE THEORY OF
PLANNED BEHAVIOR APPLIED TO
UNDERSTANDING CLINICIAN BEHAVIOR
WITHIN ORGANIZATIONAL
CONSTRAINTS AND WE HAVE SPECIFIC
BARRIERS.
SOMETHING CALLED THE
IMPLEMENTATION CLIMATE WITHIN AN
ORGANIZATION AN INTERVENTION OR
INNERVATION IS SUPPORTED AND
REWARDED AND POSITED TO BE A
CAUSAL METHOD THROUGH WHICH
EFFECTIVE IMPLEMENTATION OCCURS
AND LASTLY THERE'S EVALUATION
FRAMEWORK AND YOU MAY BE
FAMILIAR WITH REAIM WHICH IS A
LEADING FRAMEWORK WE OFTEN SEE
IN HEALTH SERVICES RESEARCH AND
THE PROCTOR IMPLEMENTATION
OUTCOME FRAMEWORK I'LL BE
SHOWING IN THE NEXT SLIDE.
HOPEFULLY THIS GIVES YOU TEETH
TO SINK INTO IN TERMS OF THE
DIFFERENT TYPES OF FRAMEWORK.
I USUALLY USE A DETERMINATE AND
EVALUATIVE FRAMEWORK AND USE
DIFFERENT ONES BASED ON THE
RESEARCH AT HAND AND THIS IS THE
PROCTOR IMPLEMENTATION OUTCOMES
FRAMEWORK THAT WAS PUBLISHED IN
2009 AND OFFERED AN INITIAL
CONCEPTUALIZATION OF HOW OUR
OUTCOMES ARE DIFFERENT FROM
TRADITION HEALTH SERVICES
OUTCOMES.
I'M GOING TO WOUK YOU THROUGH
EACH COLUMNS TO HELP YOU
UNDERSTAND WHAT IT'S SAYING.
SO THE FIRST COLUMN IS CALLED
INTERVENTION STRATEGIES.
THIS IS DISTINGUISHING THE
DIFFERENCE BETWEEN THE THING OR
EVIDENCE-BASED PRACTICE AND THE
SECOND COLUMN WHICH ARE THE
IMPLEMENTATION STRATEGIES OR THE
THINGS WE DO TO HELP PEOPLE DO
THE THING.
OFTEN PEOPLE THOUGHT OF
IMPLEMENTATION OF BEING JUST
ABOUT THE THING THEY WERE
STUDYING RATHER THAN A SEPARATE
SET OF STRATEGIES AND TECHNIQUES
TO HELP PEOPLE DO THE THING FOR
A PARTICULAR INTERVENTION.
IN THE THIRD COLUMN YOU'LL SEE
THERE'S THREE SETS OF OUTCOMES
DELINEATED WITHIN THE PROCTOR
FRAMEWORK.
WE HAVE OUR IMPLEMENTATION
OUTCOMES WHICH INCLUDE
PERCEPTUAL OUTCOMES AND HOW
FEASIBLE, ACCEPTABLE OR
APPROPRIATE A PARTICULAR THING
IS AND AS WELL AS OUR MORE
BEHAVIORAL IMPLEMENTATION
OUTCOMES WHICH INCLUDES ADOPTION
OR THE INITIAL DECISION TO ADOPT
A PARTICULAR PRACTICE AND
FIDELITY AND HOW CLOSELY
CLINICIANS IMPLEMENT THAT
PRACTICE AND PENETRATION AND
REACH AND COST AND THREES THREE
NEW OUTCOMES TO CONSIDER IN
LIGHT OF COVID-19 INCLUDING
AVAILABILITY, HEALTH EQUITY AND
SCALE UP.
THESE ARE TYPICALLY THE FOCUS OF
OUR TRIALS.
THESE ARE THE OUTCOMES WE ARE
MEASURING AND LOOKING AT AS WE
TEST DIFFERENT STRATEGIES TO
IMPLEMENT VARIOUS THINGS.
PROCESS OUTCOMES ARE DELINEATED
IN THE SECOND COLUMN AND INCLUDE
EFFICIENCY, SAFETY,
EFFECTIVENESS, EQUITY, PATIENT
CENTEREDNESS AND TIMELINESS AND
I THINK THE DISTINCTION BETWEEN
PROCESS AND IMPLEMENTATION
OUTCOMES IS FUZZY AND FINAL TLI
THE DISTINCTION, THE HEALTH
OUTCOMES AND CLINICAL
EFFECTIVENESS AND THOSE ARE
DIFFERENT FROM THE
IMPLEMENTATION PROCESS OUTCOMES.
WHY DO WE CARE SO MUCH ABOUT
THEORIES, FRAME WORKS AND
MODELS?
THEY OFFER A COMMON LANGUAGE TO
USE AND GUIDE THE PROCESS OF
RESEARCH BY ALLOWING US TO
STRUCTURE OUR STUDIES WITH
DESIGN AND MEASUREMENT AND
PRODUCE GENERALIZABLE KNOWLEDGE
WHICH IS THE ULTIMATE GOAL OF
THIS TYPE OF RESEARCH AND HELPS
WITH OPERATIONIZING THEORY AND
ENSURES WE'RE THINKING ABOUT
RELEVANT VARIABLES LIKE EQUITY
AND STRUCTURAL FACTORS.
NEXT I'LL TALK ABOUT
IMPLEMENTATION STRATEGIES WHICH
IS A TOPIC NEAR AND DEAR TO MY
HEART.
I WANT TO OFFER YOU TWO SEMINOLE
PAPERS THAT SHAPE HOW I THINK OF
THIS FOR FURTHER READING.
THESE TWO PAPERS DESCRIBE A
PROCESS OF COMING TO CONSENSUS
ON STRATEGIES THAT WE OFTEN DRAW
FROM IN THE IMPLEMENTATION WORLD
AND THE PROJECT IS CALLED THE
EXPERT RECOMMENDATION FOR
IMPLEMENTATION CHANGE AND
TAXONOMY OF IMPLEMENTATION
STRATEGIES AND WE HAVE MANY TO
DRAW FROM AND IT'S NOT AN
EXHAUSTIVE LIST.
IT'S FROM A PAPER I SUGGESTED
YOU LOOK AT IN THE PREVIOUS
SLIDE.
THESE ARE THE VARIOUS THINGS WE
DO TO HELP PEOPLE DO THE THINGS.
YOU WANT TO MATCH THESE
STRATEGIES TO WHAT THE BARRIERS
AND FACILITATORS ARE IN THE
ENVIRONMENT WHICH YOU'RE TRYING
TO IMPLEMENT.
THERE'S A SYSTEMATIC PROCESS TO
DO THAT.
IT'S BEEN BROKEN DOWN INTO
BUCKETS AND THESE ARE THE 73
STRATEGY BUCKETS AND PLANNING
STRATEGIES ASSESSING THE CONTENT
EDUCATE STRATEGIES AND TRAINING
IS NECESSARY BUT NOT SUFFICIENT.
RE-STRUCTURING, CREATING NEW
TEAMS OR REVISING ROLES AND
AUDIT AND FEEDBACK AND FINANCIAL
STRATEGIES AND POLICY
STRATEGIES.
WE HAVE A WHOLE LITERATURE ON
THIS AND IT'S IMPORTANT TO
HIGHLIGHT AND LOOK AT THE
LITERATURE AND HAVE YOUR
INVESTIGATORS LOOK AT IT BEFORE
RE-INVENTING THE WHEEL.
WE DON'T PICK IMPLEMENTATION
STRATEGIES FROM THE SKY JUST
LIKE WE DON'T GIVE EVERYBODY IN
THE EMERGENCY ROOM ASPIRIN.
WE HAVE WAYS TO SELECT
IMPLEMENTATION STRATEGIES
THOUGHTFULLY.
YOU CAN SEE AN EXAMPLE OF ONE OF
THE WAYS CONCEPT MAPPING WHICH
IS A MIXED METHODS APPROACH TO
PARTNER WITH PARTNERS AND
COMMUNITY MEMBERS TO IDENTIFY
WHAT TYPES OF STRATEGIES ARE
USEFUL AROUND WAYS TO COLLECT
THESE STRATEGIES INCLUDE THESE
CRUCIAL INGREDIENTS.
DOING A NEEDS ASSESSMENT, TRYING
TO UNDERSTAND YOUR CONTEXT AND
PARTNERS AND CONSOLIDATING THE
INPUTS INTO WORKING LOGIC MODEL
THAT GUIDES HOW YOU THINK ABOUT
WHAT STRATEGIES TO USE AND
THIRD, SPECIFY YOUR THEORY AND
OPERATIONALIZE YOUR STRATEGIES
DRAWING ON EXISTING TAXONOMIES.
WE'RE THINKING ABOUT MECHANISM
AND HOW OUR STRATEGIES WORK AND
LOOKING AT THE MECHANISM TO GET
BEHAVIOR CHANGE.
I'LL RETURN TO HOW WE CAN
IMPLEMENT THIS IN OUR WORK AND
THIS PAPER DESCRIBES HOW WE CAN
THINK ABOUT THAT INCLUDING
LOOKING AT MARGINALIZED
POPULATIONS AND ADDING
STRATEGIES TO ADDRESS STRUCTURAL
FACTORS AND UNDERSTAND PARTNER
PERSPECTIVES ON APPROACHES AND
THIS IS WORK WE'VE DONE IN OUR
VARIOUS TRIALS AND I FIND IT
INCREDIBLY IMPORTANT.
AND THE HEALTH EQUITY AND
EFFORTS THE NATIONAL EYE
INSTITUTE IS PARTNERING AROUND I
ENCOURAGE YOU TO THINK ABOUT IT
WITH THE IMPLEMENTATION SCIENCE
LENS.
THE LAST CRUCIAL INGREDIENTS
I'LL COVER IN THE TIME WE HAVE
IS MEASUREMENT AND ANALYSIS.
I'LL KEEP THIS HIGH LEVEL AND
BRING YOU BACK TO THE VISUAL
AROUND IMPLEMENTATION OUTCOMES
AND THE PROCTOR FRAMEWORK AND
THE OUTCOMES ARE DIFFERENT FROM
OUR HEALTH OUTCOMES.
WE CAN MEASURE BOTH AND IT'S
NICE WHEN THERE'S EXISTING
REGISTRIES TO DRAW FROM SO YOU
DON'T HAVE TO DO PRIMARY DATA
COLLECTION FOR BOTH BUCKETS OF
OUTCOMES.
MAKE SURE YOU LOOK AT EQUITY
ACROSS YOUR OUTCOMES SO YOU
IDENTIFY IF THERE'S EXISTING
INEQUITIES AND LOOK WHEN YOU DO
IMPLEMENTATION TO MAKE SURE IT'S
NOT BEING DEPLOYED UNEVENLY AND
DO WORK TO IDENTIFY NEW SIGNALS
THAT MAY COME UP IN THE
IMPLEMENTATION PROCESS.
THIS IS WORK MY COLLEAGUE HAS
BEEN AT THE FOREFRONT OF AND
HAVE A PAPER IN PRESS THAT
DESCRIBES HOW WE DID THIS IN A
RECENT TRIAL THAT PAINT A NICE
PICTURE HOW THIS CAN BE DONE
CONCRETELY.
QUALITATIVE AND MIXED METHODS
AND ADD TO THE CHARACTERIZATION
OF OUR IMPLEMENTATION OUTCOMES.
WE EMBRACE AND WELCOME BOTH
QUANTITATIVE AND MIXED METHODS
APPROACH AND ALMOST EVERY BIG
TRIAL HAS A MIXED METHODS
COMPONENT TO ENRICH OUR
UNDERSTANDING.
I'LL GIVE AN EXAMPLE AND THEN
OPEN IT UP FOR QUESTIONS.
I'VE BEEN FORTUNATE OVER THE
PAST 6, 7 YEARS TO BE FUNDED BY
THE NATIONAL INSTITUTE OF MENTAL
HEALTH TO DO WORK AROUND A
PARTICULAR CHALLENGE THAT WE
HAVE NATIONALLY WHICH IS SEEING
INCREASED SUICIDE IN YOUNG
PEOPLE IN OUR COUNTRY AND ONE OF
THE MAJOR DRIVERS IS ENSURING
THAT FIREARMS ARE SECURED SAFELY
IN HOMES.
GIVEN 1 IN 3 HOMES HAVE
FIREARMS, HALF SUICIDE DEATHS
ARE DUE TO FIREARMS AND KNOW
MORE SECURE STORAGE WOULD REDUCE
THE NUMBERS.
THAT'S THE KIND OF GAP WE HAVE
BEEN FOCUSSED ON.
WE'RE FOCUSSED ON A SECURE
STORAGE PROGRAM TO BE DEPLOYED
IN PEDIATRIC PRIMARY CARE AS THE
SUICIDE PREVENTION STRATEGY AND
SEE THE QUESTION OF THE PRACTICE
SHOWING EFFECTIVENESS.
IN 2008 THERE WAS A TRIAL
DEMONSTRATING DOING THIS THING
IN PEDIATRIC PRIMARY CARE
RESULTED IN MORE SECURE STORAGE
OF FIREARMS.
AT THE TIME THEY WERE FOCUSSED
ON UNINTENTIONAL
AND WE KNEW WE COULD ADAPT
METHODS FOR PREVENTION AND LOOK
AT CURRENT USE OF THE COMPONENT
OF THIS PROGRAM AS WELL AS
ATTITUDES OF CLINICIANS AND
LEADERS IN HEALTH SYSTEMS
TOWARDS THE COMPONENTS OF THIS
PROGRAM.
THAT ALLOWED US TO ENGAGE IN A
PROCESS CALLED IMPLEMENTATION
MAPPING TO DESIGN A MENU OF
IMPLEMENTATION STRATEGIES BASED
ON WHAT WE HEARD WHICH WAS THAT
INTEGRATION IN THE ELECTRONIC
HEALTH RECORD AND HELPING
NAVIGATE THE SENSITIVITY OF THE
TOPIC WOULD BE CRITICAL TO
ENSURE THE SUCCESS OF THIS
APPROACH.
BECAUSE WE MADE ADAPTATION WE'RE
DOING A TRIAL ASKING THE
FOLLOWING QUESTIONS.
LESS COSTLY AND SCALABLE HEALTH
RECORDS NUDGE POWERFUL ENOUGH TO
CHANGE CLINICIAN BEHAVIOR OR IS
MORE NEEDED TO OVERCOME
IMPLEMENTATION BARRIERS?
WE HAVE 30 CLINICS.
HALF HAVE JUST GETTING A CHANGE
TO THE WELL CHILD VISIT TEMPLATE
TO PROMPT CLINICIANS TO DO THE
PROGRAM.
THE OTHER HALF ARE GETTING THE
NUDGE AND CLINICAL LEVEL
FACILITATION AND DEPLOYING THE
INTERVENTION AND HOPEFULLY THAT
GIVES YOU A PICTURE OF HOW ONE
MIGHT GO THROUGH THE STEPS IN
DECIDING HOW TO DO AN
IMPLEMENTATION SETTING.
AND MY PARTICULAR CONTENT AREA.
I'LL CLOSE AND TALK ABOUT
APPLICATION OF IMPLEMENTATION
SCIENCE AT THE NATIONAL EYE
INSTITUTE FUNDED WORK AND
PULLING A UG1 FUNDED TO DR. LU
AT THE UNIVERSITY OF WISCONSIN
AS AN EXAMPLE.
THIS IS NOT MY CONTENT AREA SO
WELCOME YOUR INPUT AND I'LL DO
MY BEST TO DESCRIBE IT AND WE'LL
TAKE IT FROM THERE.
THE THING WE'RE INTERESTED IN
HERE IS OPHTHALMOLOGY FOR
DIABETIC RETINOPATHY AND IT
SHOWS THE FIELD HAS DEMONSTRATED
THIS IS EFFICACIOUS AND
EFFECTIVE AND DR. LU HAD A K23,
I UNDERSTAND TO DO MIXED METHODS
WORK TO UNDERSTAND BARRIERS TO
THE I AM MOMPLEMENTATION AND NOG
A LARGE TRIAL TESTING THE
STRATEGIES AND THEY'RE BASED ON
ANOTHER MODEL ADAPTED FOR THIS
PARTICULAR USE CASE AND SHE
DESIGNED AND PILOTED THIS MODEL.
ON THE LEFT IS THE WORK THAT
CAME THE EARLIER MIXED METHODS
IMPLEMENTATION WORK AND SCIENCE
COMMUNICATION AND THE AIMS OF
HER STUDY.
SHE'S TESTING THE EFFECTIVENESS
OF THE IMPLEMENTATION STRATEGY,
EYESIGHT, VERSUS USUAL PAIR TO
LOOK AT WHETHER OR NOT THAT
INCREASES DIABETIC SCREENING
RATE AND LOOKING AT IT ACROSS
EIGHT RURAL HEALTH SYSTEMS IN
FIVE STATES.
THE INITIAL WORK WAS DONE IN THE
SMALLER NUMBER AND NOW WHEN WE
DO IMPLEMENTATION WORK WE'RE
DOING IT IN MANY MORE SITES.
THE SECOND IS TO UNDERSTAND KEY
FACTORS AND IMPLEMENTATION
COMPONENTS YOU CAN SEE IN HIGH
AND LOW USE HEALTH SYSTEMS.
THAT'S UNDERSTANDING WHAT
CHARACTERIZES HIGH AND LOW USING
AND HER THIRD AIM IS TO LOOK AT
IMPLEMENTATION OUTCOME WHICH IS
IMPORTANT AND COST.
AND YOU CAN SEE HOW THE EXAMPLE
BRINGS TOGETHER THE THINGS WE'VE
BEEN TALKING ABOUT.
THERE'S LOTS OF OTHER
OPPORTUNITIES IN IMPLEMENTATION
SCIENCE AND WE HEARD THAT IN THE
COMMENTS MIKE MADE LEADING UP TO
THE TALK.
IT SEEMS LIKE IN YOUR FIELD
THERE'S A LOT OF WELL
ARTICULATED DATA SCIENCE AND
REGISTRIES WHICH CAN BE USED TO
ASCERTAIN OUTCOMES AND IDENTIFY
CARE GAPS AND INEQUITIES.
THAT GIVES A FOOT UP BECAUSE IF
YOU'RE ABLE IT DRAW FROM THOSE
INFRASTRUCTURE RESOURCES IT
MAKES FOR EASIER GOING FORWARD.
SECOND, AND YOU'LL BE HEARING
FROM JENNY AFTER ME, THERE'S AN
OPPORTUNITY TO LEVERAGE THE
NETWORKS INCLUDING OVER 100
CLINICAL SITES AND THE STUDY I
WAS DESCRIBING THAT REFLECTS MY
OWN WORK LEVERAGES AN NIMH
NETWORK THAT'S HOW WE WERE ABLE
TO DO THE WORK I COULDN'T HAVE
DONE IT WITHOUT THE
INFRASTRUCTURE.
THE THIRD AREA AND I KNOW
THERE'S BASIC SCIENTISTS ON THE
CALL PARTNERING WITH
IMPLEMENTATION SCIENCES TO
PRODUCE MEANINGFUL TEAM SCIENCE
FROM BENCH TO BEDSIDE TO ADVANCE
THE MISSION IS MISSION CRITICAL.
I'D LIKE TO SEE A FUTURE WHERE
THERE'S MORE TEAM SCIENCE FROM
THE BEGINNING RATHER THAN
CALLING ONCE YOU HAVE THE THING.
IT TENDS TO RESULT IN A HARDER
PATHWAY FORWARD AND THINKING HOW
TO PRIORITIZE HYBRID TRIALS OF
CLINICAL EFFECTIVENESS AND REAL
WORLD IMPLEMENTATION OUTCOMES
EARLIER WE SHOULD THINK ABOUT
IMPLEMENTATION BECAUSE WE'RE
DOING THINGS TO MAKE THE THING
WORK I HAVE A COLLEAGUE THAT
WROTE A PAPER CALLING FOR
REPORTING THE STRATEGIES, USED
IN THE EARLIER EFFECTIVENESS
STUDIES.
I BELIEVE IMPLEMENTATION SCIENCE
CAN HELP MOVE THE NEEDLE AND
ACHIEVE IMPACT AT SCALE AND HOPE
THIS HAS GENERATED IDEAS AND
THINK WE'RE AT A PIVOTAL TIME.
THE SCIENCE EDITORIAL IS A GOOD
INDICATOR OF THE FUTURE AND THE
FACT THAT PEOPLE ARE COMING
AROUND TO HOW IMPORTANT THIS
WORK IS.
I'VE BEEN DOING IT 20 YEARS AND
IT'S VERY FULFILLING TO SEE IT
COME TO FRUITION IN THIS WAY.
AND I WANT TO GIVE DEEP
GRATITUDE TO THE TEAM AND OUR
COLLEAGUES AND FAMILY AND OF
COURSE MY INSTITUTION AND
PREVIOUS INSTITUTION WHICH
SUPPORTS THE IMPORTANT WORK.
MY E-MAIL IS HERE AND TWITTER
HANDLE AND FOLLOWED THE HASHTAG
EYE INSTITUTE AND I USE IT A LOT
TO SHARE IMPLEMENTATION SCIENCE
WORK AND I'LL CLOSE AND SEE IF
THERE'S ANY QUESTIONS THAT
PEOPLE HAVE IN THE TIME I HAVE
REMAINING.
>>THANK YOU.
AWESOME TOUR AND I APPRECIATED
YOUR INTEGRATING WHAT IS GOING
ON HERE WITH WHAT YOU'RE DOING.
LET ME -- WHAT QUESTIONS DO
PEOPLE HAVE?
MAUREEN.
>>THAT WAS AN INTERESTING TALK.
SINCE YOU'VE BEEN WORKING THIS
FIELD SO LONG, ARE THERE SORT OF
SOME LOW HANGING FRUIT --
DOESN'T MATTER WHAT DISCIPLINE
YOU'RE IN.
ARE THERE CERTAIN STRATEGIES
THAT SEEM TO WORK ACROSS
MEDICINE?
SOME BASIC ABCs OUT THERE FOR
DISSEMINATING INFORMATION AND
HAVING IT ADOPTED?
>>THAT'S A GREAT QUESTION,
MAUREEN.
THANK YOU FOR ASKING IT.
I CAN'T GIVE YOU A PLAY BOOK OF
HOW THIS IS HOW YOU CAN
IMPLEMENT EVERYTHING AT EVERY
PLACE BECAUSE THAT DOESN'T EXIST
BUT THE PROCESS I OUTLINED WHERE
YOU DIAGNOSE THE FACILITATORS
AND PICK STRATEGIES AND DEPLOY
THEM IS A PROCESS THAT'S
UBIQUITOUS AND ONE, WE ALWAYS
WANT TO GO FOR INDIVIDUAL LEVEL
STRATEGIES TO CHANGE BEHAVIOR.
WE ALWAYS THINK THE CLINICIANS
DON'T KNOW HOW TO USE IT SO WE
TRAIN THEM AND GIVE THEM
INFORMATION THEY'LL CHANGE THEIR
BEHAVIOR.
I CAN TELL YOU THAT DOESN'T WORK
AND WE KNOW THAT.
I THINK THERE'S LOW HANGING
FRUIT FROM BEHAVIORAL SCIENCE OR
ECONOMICS TO RESTRUCTURE THE
ENVIRONMENT TO MAKE IT EASIER
FOR CLINICIANS AND PATIENT TO DO
THE RIGHT THING.
TO ME NUDGING THE ELECTRONIC
HEALTH RECORD IS A LOW COST
APPROACH TO NUDGE WHAT YOU
SHOULD ATTEND TO AND FOR THE
THINGS WE CARE ABOUT IN A HEALTH
SYSTEM WE'LL HAVE TO DO MORE.
THAT COULD BE AUDIT AND
FEEDBACK.
THAT'S GOING TO BE ORGANIZE OF
ORGANIZATIONAL STRATEGY TO MAKE
SURE WE SIGNAL TO THE
ORGANIZATION AT THE MATTERS AND
WE EXPECT PEOPLE TO DO IT.
AND THOSE ORGANIZATIONAL-LEVEL
STRATEGIES ARE HARDER AND MORE
EXPENSIVE.
WE CAN'T DO IT FOR EVERYTHING SO
WE HAVE TO BE MORE TARGETED AND
PRIORITIZE WHAT NEEDS TO BE
DONE.
FINALLY, THERE'S NO SILVER
BULLET.
AS THE INCREMENTAL CHANGE AND
MEASUREMENT AND LOOKING AT WHAT
HAPPENS AND CONTINUE TO SHIFT
FROM HEARING WHAT IS HAPPENING
ON THE GROUND.
>>THAT'S TERRIFIC.
I GUESS THERE'S BITS AND PIECES
OF IMPLEMENTATION SCIENCE BUT
MAYBE I'D LIKE TO FIGURE OUT HOW
TO LEARN MORE ABOUT IT AND FROM
THE LITERATURE AND READ IT.
ARE THERE SPECIFIC JOURNALS FOR
EXAMPLE OR CAN YOU SUGGEST AREAS
TO GO TO TO LEARN MORE?
>>ABSOLUTELY, THANK YOU, EMMY.
GREAT QUESTION.
I THINK IT'S IMPORTANT TO DO
MORE LEARNING AND IF I GO IN THE
LAB AND PICK UP AN iPAD IT'S A
DISTINCT FIELD THAT REQUIRES
LEARNING.
THERE'S ABOUT TO BE A TEXTBOOK
THAT'S A GOOD STARTING PLACE.
THERE'S A JOURNAL CALLED
IMPLEMENTATION SCIENCE AND NOW A
SISTER JOURNAL, IMPLEMENTATION
SCIENCE COMMUNICATION FOR
EARLIER STAGE WORK THAT'S A
GREAT PLACE TO GO.
AND THERE'S A WHOLE OUTCROP OF
NEW JOURNALS COMING OUT AND I'M
SEEING IT MORE IN SOME OF OUR
WELL KNOWN MEDICAL JOURNALS.
THERE'S A CONFERENCE ANNUALLY
THAT NIH AND ACADEMY HEALTH
SPONSOR AND REPRESENTS WORK
ACROSS DISEASE AREAS AND IT'S IN
DECEMBER AND IT'S A GREAT WAY
AND I'D ENCOURAGE YOU TO
PARTNER.
MY MOST SUCCESSFUL PROJECT
OUTSIDE MY CONTENT AREAS ARE
ONES IN WHICH I PARTNER WITH
CLINICAL EXPERTS DOING PRAGMATIC
TRIALS AND THEIR SETTINGS TO
DESIGN AND IMPLEMENT A STUDY.
IT'S IMPORTANT THE
IMPLEMENTATION SCIENTISTS BE
FULLY INVOLVED.
WHEN PEOPLE COME TO ME AND SAY
I'VE NEVER DONE THIS BEFORE, CAN
YOU BE 3% TO 5% AND HELP THE
STUDY I SAY NO.
YOU CAN'T DO IT WELL.
I COULDN'T GO IN THE WET LAB AND
HELP GUIDE WHAT I'M DOING.
HOPEFULLY THAT ANSWERS YOUR
QUESTION.
>>MY UNDERSTANDING IS YOU HAVE
A HARD STOP IN A MINUTE OR
SHOULD WE STOP?
>>WE HAVE A MINUTE BUFFER.
I'M HAPPY TO ANSWER THE
QUESTION.
>>WHAT RESONATED WITH ME IS THE
DISCONNECT BETWEEN BASIC AND
CLINICAL RESEARCH.
AND PARTNERING WOULD BE KEY AND
SOME PROGRAMS TO PROMOTE THAT
WOULD BE NICE.
>>WHEN PEOPLE TALK ABOUT CELLS
AND MICE IT'S NOT MY LOVE
LANGUAGE.
IT'S TALKING ABOUT CLINICIANS
AND PATIENTS AND ORGANIZATION.
WE NEED TO DO BETTER AT BRIDGING
THE GAP AND I'M SURE IT'S TRUE
FOR BASIC SCIENTISTS WHEN THEY
START HEARING ME DESCRIBE IT'S
MESSY AND LARGE ECO SYSTEM WE'RE
DOING WORK IN.
I THINK IT'S REALLY IMPORTANT
AND I THINK WE NEED TO
INCORPORATE TRAINING EARLIER TO
BUILD CAPACITY AND THERE'S A
REAL SUPPLY AND DEMAND ISSUE.
THERE'S NOT A LOT OF
IMPLEMENTATION SCIENTISTS.
THERE'S NOT ENOUGH THAT HAVE
BEEN TRAINED TO MEET THE NEEDS
AS NEW AREAS ARE IDENTIFYING
THIS AS A NEED THANK YOU ALL SO
MUCH FOR THE INVITATION.
HAVE YOU MY CONTACT INFORMATION.
I HOPE TO SEE THIS WORK EXPLODE
WITHIN THE NEI PORTFOLIO AND
LOOK FORWARD TO CONTINUING THE
CONVERSATION.
>>THANK YOU FOR DOING THIS
ESPECIALLY IN THE MIDDLE OF A
BUSY JOB AN LIFE TRANSITION FOR
YOU AND WE'LL LOOK FORWARD TO
STAYING IN TOUCH.
OBVIOUSLY FINDING WAYS WE CAN DO
THINGS TOGETHER.
THANK YOU AGAIN.
>>THANK YOU.
>>JENNY, MAY I INTRODUCE YOU?
>>ABSOLUTELY.
THANK YOU, MIKE.
>>THIS IS GOING TO BE A GREAT
TALK TO FOLLOW ON WHAT RINAD HAD
TALKED ABOUT.
LET ME -- JENNIFER SUN IS AN
ASSOCIATE PROFESSOR AT HARVARD
AT THE JOCELYN DIABETES CENTER
AND DIRECTS CLINICAL EYE
RESEARCH THERE AND SHE IS
BASICALLY HAS BEEN REELECTED AS
A SECOND TERM OF THE CHAIR FOR
DIABETES INITIATIVES AT THE DRCR
RETINA NETWORK WHICH IS ONE OF
OUR TWO MAIN NEI FUNDED
COLLABORATIVE RESEARCH NETWORKS.
IT HAS ORIGINS IN DIABETIC
RETINOPATHY AND DOES RESEARCH
MORE BROADLY.
JENNY'S BEEN CHAIR ON DRCR
RETINA STUDIES.
SHE'S THE CO-SCIENTIFIC DIRECTOR
FOR THE MARY TYLER MOORE VISION
INITIATIVE BASICALLY LOOKING AT
RETINOPATHY STAGING.
AND IN DOING THAT SHE WORKS WITH
PEOPLE LIKE TOM GARDNER AND WITH
THAT EXCITED TO HEAR JENNY TALK
ABOUT DISSEMINATION OF CLINICAL
TRIAL RESULTS.
MAY I TURN TO YOU?
THANK YOU FOR BEING HERE.
>>THANK YOU SO MUCH.
I'LL SHARE MY SCREEN AND SLIDES
AND HOPEFULLY I APPRECIATE THE
OPPORTUNITY TO BE HERE AND
EXCITING TO BE PART OF THE
CONVERSATION.
I KNOW A LITTLE ABOUT
IMPLEMENTATION SCIENCE AND I'LL
TALK ABOUT THE THINGS RI NARD
TALKED ABOUT IN TERMS OF THE
THINGS WE'RE LOOKING TO
UNDERSTAND WITH IMPLEMENTATION
SCIENCE.
HERE'S MY FINANCIAL DISCLOSURES.
RINAD I'LL TRANSITION FROM HER
TALK BY SHOWING ONE OF HER
SLIDES.
SHE MENTIONED ONE OF THE
ASSUMPTIONS IS THERE'S AN
EVIDENCE-BASED THING TO BE
IMPLEMENTED.
MY TALK WILL FOCUS ON WHAT ARE
THE EVIDENCE-BASED THINGS OR
PRACTICES THAT WE HAVE IN
OPHTHALMOLOGY AND THOUGHT I'D
FOCUS ON THIS SET OF MAJOR
QUESTIONS.
HOW DO WE DEVELOP NEW PRACTICES
AND HOW DO WE DETERMINE WHICH
PRACTICES WILL BENEFIT OUR
PATIENTS AND DISSEMINATE
INFORMATION TO THE COMMUNITY AND
ONE THING I'LL POSE IS HOW DO WE
KNOW WHETHER THE PRACTICES ARE
BEING SUCCESSFULLY IMPLEMENTED
IN CLINICAL CARE?
I'M GOING IT TALK ABOUT THIS
THROUGH THE LENS OF MY VERY
SPECIFIC WORK IN DIABETIC
RETINAL DISEASE.
THOUGH THERE'S A WIDE RANGE OF
EXPERTISE IN THE COUNCIL MANY
ARE FAMILIAR WITH THE STAGING
SYSTEM THAT WAS DEVELOPED IN THE
EARLY TREATMENT OF DIABETIC
RETINOPATHY TO GRADE SEVERITY
BASED ON THE LESIONS THAT
DEVELOP THAT MOVE THROUGH THE
SPECTRUM OF NO DIABETIC
RETINOPATHY TO MILD, AND MORE
ADVANCED STAGES WHERE PATIENTS
MAY DEVELOP NEW ABNORMAL VESSELS
AND AT RISK OF BLEEDING AND
VISION LOSS.
AND OVER THE DECADES WE'VE GROWN
TO UNDERSTAND THERE'S A LARGE
DEGREE OF NEURAL RETINAL
DEGENERATION THAT ACCOMPANIES
THESE STAGES THAT'S NOT
ADDRESSED AND PARTS CAN GET
SWELLING OF THE RETINA WHICH IS
A COMMON VISION LOSS CAUSE.
MIKE MENTIONED THE VISION
INITIATIVE AND TOM IS A LARGE
PART OF THAT AND WE FOCUS ON AN
EARLIER EFFORT AND BROADEN THE
UNDERSTANDING OF DIABETIC
RETINAL DISEASE AND LOOKING AT
ONE THAT'S MORE WHOLISTIC
ENCOMPASSING NEURAL FUNCTION AND
THE RETINA AND THE SYSTEMIC
HEALTH OF THE PATIENT THAT'S
IMPORTANT IN TERMS OF GLYCEMIC
CONTROL AND CONTROL OF OTHER
RISK FACTORS.
ALL THOSE TIE INTO HOW PATIENT'S
VISUAL FUNCTION CHANGES OVER THE
COURSE OF THEIR LIFE AND QUALITY
OF LIFE AS WELL WHICH IS
IMPORTANT TO CONSIDER AS WE
THINK ABOUT NEW TREATMENTS, HOW
IT AFFECTS PATIENTS DIRECTLY.
I'LL TALK ABOUT DIABETIC RETINAL
DISEASE AND SPECIFICALLY THE
EFFORTS THAT HAVE BEEN PERFORMED
IN DIABETIC RETINAL DISEASE IN
STUDIES FROM THE RETINA NETWORK.
IT'S KNOWN AS THE DIABETIC
RETINOPATHY CLINIC STUDIES
NETWORK AND WE'RE A
COLLABORATIVE NETWORK OF DIVERSE
SITES ACROSS NORTH AMERICA,
U.S. AND CANADA AND DEDICATED TO
WHAT WE HOPE IS VIGOROUS
IMPACTFUL RESEARCH OF RETINAL
DISEASES.
AND I'LL USE OUR STUDIES AS AN
EXAMPLE MOVING FORWARD, THIS
NETWORK WAS INITIALLY CONCEIVED
OF IN 2002 WHEN THE NATIONAL EYE
INSTITUTE DISTRIBUTED THE RFA TO
CREATE AN INFRASTRUCTURE TO
ACCELERATE DEVELOPMENT AND
CONDUCT CLINICAL STUDIES IN
DIABETIC RETINOPATHY AND IT WAS
CREATED IN CONTEXT OF TWO
REALIZATIONS.
ONE WAS THAT THERE HAD NOT BEEN
A MAJOR ADVANCE SINCE THE
DEVELOPMENT OF THE LASER WHICH
WAS FIRST CONCEIVED IN THE LATE
1960s.
AND SECONDLY, THIS WAS A VERY
EXCITING TIMES BECAUSE THERE
WERE NEW PATHWAYS AND VASCULAR
ENDOTHELIAL GROWTH FACTOR AND IT
WAS UNDERSTOOD THIS WOULD BE A
NEW ERA IN THE UNDERSTANDING OF
THE NEW MOLECULAR PATHWAYS OF
THERAPEUTICS TO TARGET THEM.
IN 2002 THE DIABETIC RETINOPATHY
RESEARCH NETWORK WAS CREATED AND
OVER THE SUBSEQUENT 20 YEARS
WE'VE PERFORMED AND BEGUN 38
MULTI-CENTER STUDIES WITH 117
PUBLICATIONS IN THE
PEER-REVIEWED LITERATURE.
WE WERE HONORED AND PLEASED IN
2017 THE NATIONAL EYE INSTITUTE
RECOGNIZED OUR SUCCESS IN THE BY
EXPANDING OUR SCOPE TO ALL
RETINAL DISEASES.
OUR COLLABORATIVE NETWORK IS ONE
OF THE CENTRAL CORES AND WE HAVE
BEEN GUIDED THROUGH MANY YEARS
NOW OF OUR WORK TOGETHER.
AND OUR COORDINATING CENTER IS
EXTRAORDINARY.
AND WE HAVE THE EXECUTIVE
DIRECTOR AND WE ARE PRIVILEGED
TO WORK WITH THEM AND TALENTED
FOLKS ON THE STUDIES.
AND DAN MARTIN AND I HAVE AND
HE'S FROM THE CLEVELAND CLINIC
AND WE HAVE A CHAIR FROM OTHER
RETINAL DISEASES AND OUR SITES
ARE THE LIFE BLOOD OF OUR
NETWORK AND TO GIVE A SNAPSHOT
OF OUR PARTICIPATION WE HAD 139
ACTIVE SITES AND 389
INVESTIGATORS AND OTHER
PERSONNEL IN THE UNITED STATES
AND CANADA.
THIS IS FAR REACHING IN NORTH
AMERICA.
TO DATE WE'VE COMPLETED 30
STUDIES.
THIS IS COMPLETED NETWORK
PROTOCOL.
S.
YOU SEE THE TIME LINES FOR
EQUIPMENT AND THE NUMBER OF
STUDIES WE PERFORMED HAS ALLOWED
US TO REACH ACROSS THE BREADTH
OF COMPLICATIONS AND THE
SEVERITY STAGES OF RETINOPATHY.
I'LL TALK ABOUT THESE AS WE GO
FORWARD.
AND ANOTHER THING TO NOTE IS WE
NAME OUR PROTOCOLS BY LETTERS OF
THE ALPHABET AND PART WITH
PROTOCOL A, OUR LASER PROTOCOL
AND NOW IN OUR SECOND ALPHABET.
OUR NEXT STUDY TO BE STOOD UP
WILL BE PROTOCOL AO.
LET'S START TALKING ABOUT
DEVELOPMENT, DETERMINATION AND
DISSEMINATION.
I'LL START BY ASKING HOW DO WE
EVOLVE NEW PRACTICES THAT CAN BE
EVALUATED FOR USE IN CLINICAL
CARE?
WE DO THIS THROUGH OUR CLINICAL
STUDIES.
IT'S WORTHWHILE TO TALK ABOUT
THE REVOLUTION OF OUR STUDIES
AND HOW THEY'VE DEVELOPED.
WE ACCEPT IDEAS TO THE NETWORK
THROUGH THE COORDINATING CENTER
AND WE'LL TYPICALLY REQUEST NEW
PROTOCOL IDEAS FROM
INVESTIGATORS TWICE A YEAR AND
WE WELCOME THEM ANY TIME OF THE
YEAR INTERNAL.
THE FORMS ARE PUBLIC AVAILABLE
ONLINE AND ONE STEERING
COMMITTEE THAT FOCUSES ON THE
DIABETES STUDIES AND ONE THAT
FOCUSES ON THE RETINAL STUDIES.
THE STEERING COMMITTEE REVIEWS
PROPOSALS FOR SCIENTIFIC MERIT
AND IF THERE'S ENTHUSIASM TO
MOVE FORWARD AND THERE'S A LARGE
FUNNEL BECAUSE WE FIND THAT
FREQUENTLY THERE ARE QUESTIONS
OF INTEREST TO THE PUBLIC OR
PROPOSERS WE MAY HAVE CONSIDERED
BEFORE AND KNOW FOR SURE IT'S
NOT GOING TO MOVE FORWARD FOR
FEASIBILITY REASONS OR EXPERTISE
IN THE NETWORK AND IDEAS WE
THINK HAVE POTENTIAL TO MOVE
FORWARD ARE PRESENTED AND WE GO
BACK TO IN-PERSON MEETINGS FOR
THE FIRST TIME THIS AUGUST.
WE REVIEWED THE IDEAS IN THE
STEERING COMMITTEES TO SEE IF
THERE'S ANY FEEDBACK THAT HAS
CHANGED OUR APPROACH PERHAPS OR
CAN WE GIVE ADDITIONAL TIPS TO
THE PEOPLE THAT ROW POSE THE
IDEA TO TWEAK PROTOCOL PROPOSALS
TO MAKE THEM MORE LIKELY TO MOVE
FORWARD AND THEN PRIORITIZED
IDEAS ARE PRESENTED TO OUR
EXECUTIVE COMMITTEE AND IT'S THE
BODY THAT PRIORITIZES PROTOCOL
DEVELOPMENT BASED ON OUR NETWORK
RESOURCES AND WHAT WE THINK IS
THE PUBLIC HEALTH IMPORTANCE OF
THESE IDEAS.
IF AN IDEA MAKES IT THROUGH
THAT, IT'S JUST THE BEGINNING OF
THE PROTOCOL DEVELOPMENT
PROCESS.
INITIAL PROTOCOLS ARE CREATED
AND TYPICALLY OUR COMMITTEES WE
SPEND THREE MONTHS TO A YEAR ON
THE PROTOCOL DRAFTING.
IT'S THEN REVIEWED BY OUR
NETWORK AND COLLABORATORS AND
ASK FOR COMMITTEE MEMBERS TO DO
DETAILED REVIEW AND WE WANT
SOMEBODY LOOKING AT THIS WITH
FRESH EYES AND SIGH IF THERE'S
ANYTHING WE MISSED DURING THE
DEVELOPMENT PROCESS.
WE UNDER GO REVIEW FROM THE
COMMITTEE AND THEN THE
PROTOCOL'S REVIEWED AND REVISED
WITH COMMENTS AND HOPEFULLY GET
APPROVAL TO PROCEED WITH THE
STUDY.
WE ALSO HAVE A PROTOCOL APPROVED
BY OUR DATA SAFETY MONITORING
COMMITTEE AND REVISED BASED ON
THE COMMENTS.
ALL THESE STEPS LEAD TO A FINAL
PROTOCOL.
AND YOU CAN IMAGINE THERE'S AN
ENORMOUS AMOUNT OF REVISION AND
DISCUSSION AND RICH DISCUSSION
OVER THE COURSE OF ALL THESE
VARIOUS STEPS OF MULTI-LAYERED
APPROVAL.
OUR MOST RECENT STUDY WE
COMPLETED WAS PUBLISHED IN
AUGUST IN THE NEW ENGLAND
JOURNAL OF MEDICINE.
THIS WAS THE FIRST PHASE 3 STUDY
FOR MACULAR EDEMA AND TYPICALLY
YOU USE A LESS EXPENSIVE
MEDICATION OR INTERVENTION FIRST
AND ONLY MOVING TO MORE
EXPENSIVE AND OFFICIALLY MORE
EFFICACIOUS MEDICATIONS OR
INTERVENTIONS AFTER.
THIS STUDY LOOKED AT PATIENTS
WITH MACULAR EDEMA AND
RANDOMIZED THEM TO THE CURRENT
STANDARD THERAPY AND THERE'S A
MEDICATION INJECTED IN THE EYES.
IT'S BEEN SHOWN TO BE THE MOST
EFFECTIVE IN THREE OF OUR MOST
USED MEDICATION IN A PRIOR
NETWORK STUDY AND WE COMPARED IT
TO THE FIRST STRATEGY AND
STARTED LOOKING AT BEVACIZUMAB
AND A SWITCH IF MORE OPTIMAL AND
FOUND THAT STRATEGY WAS
EFFECTIVE AT IMPROVING VISION
OVER TWO YEARS STARTING
IMMEDIATELY.
THERE'S LARGE COST AVAILABILITY
WITHIN THE DRUGS.
THERE'S A 26 FOLD COST
DIFFERENCE AND I THINK THE STUDY
OUTLINES A STANDARDIZED REGIMENT
USING OUR INJECTIONS OF
MEDICATION AND CRITERIA WE USED
TO DETERMINE WHEN PATIENTS
SHOULD SWITCH THAT CAN BE USED
IN CLINICAL CARE.
AND SO I'M GOING TO WALK YOU
THROUGH A LITTLE BIT OF A
PROCESS OF OUR SWITCH CRITERIA.
THIS WAS A CRITICAL PART OF OUR
STUDY.
WE STARTED THE DISCUSSION BACK
IN APRIL 2016 AND WE ASKED THE
COMMITTEE IN THE STUDY, HOW MUCH
SHOULD THE SWITCH CRITERIA BE
DEFINED?
WE GAVE OUR COMMITTEE SIX
OPTIONS.
AND BASICALLY WE PRIORITIZED
SWITCHING IN DIFFERENT WAYS.
WE SAID DO YOU PRIORITIZE VISUAL
ACUITY BY ITSELF OR AS WELL AS
WHAT'S HAPPENING WITH THE
THICKENING.
WHAT ABOUT TRENDS OR CHANGES
OVER TIME?
DO YOU THINK WE WANT TO SWITCH
EYES THAT ARE GETTING WORSE IN
VISION.
THIS FRANKLY DOESN'T HAPPEN
OFTEN SO PERHAPS WE WANT TO
SWITCH THE EYE ARE NOT IMPROVING
SUFFICIENTLY AND THIS IS FROM A
DEDICATED GROUP OF PEOPLE ON
THIS ULTIMATELY WE DECIDED WE
WANTED PHILOSOPHICALLY TO SWITCH
EYES THAT WERE NOT IMPROVING
SUFFICIENTLY AND CAME UP WITH A
SWITCH CRITERIA.
THIS IS OUR FINAL SWITCH
CRITERIA IB A FLOW CHART AND YOU
CAN SEE IT'S QUITE DETAILED.
THIS IS ONE OF THE THINGS WE TRY
TO BALANCE AS WE WRITE ALGOR
ALGORITHMS IN CLINICAL TRIALS
AND WE'RE TRYING TO REDUCE
INVESTIGATOR DISCRETION OR
POTENTIAL CONFOUNDERS IN HOW
DECISIONS ARE MADE.
WE'RE ABLE TO DO THIS IN THE
RETINA NETWORK STUDIES BECAUSE
WE HAVE COMPUTER SUPPORT BEHIND
OUR DECISION MAKING AND BUILD IN
ALGORITHMS AND THEY'RE ABLE TO
ENTER IN THE VISUAL ACUITY DATA
AND GIVEN ALL THE DATA THIS IS
WHAT YOU SHOULD DO IF YOU
DISAGREE WITH THE TREATMENT
PLAN.
WE HAVE REMARKABLE ADHERENCE TO
THESE KINDS OF ALGORITHMS IN OUR
CLINIC STUDIES.
IT'S NOT ALWAYS VEIL.
THE NEXT PHASE IS WHAT HAPPENED
AS WE MOVED FROM THE SWITCH
TREATMENT AND IN AUGUST OF THIS
YEAR WE STARTED TO THINK ABOUT
PRESENTING THE SWITCH CRITERIA
AND CAME UP WITH WHAT WE HOPE IS
AN EASY TO REMEMBER AND EASY TO
IMPLEMENT WAY TO DEFINE THE
CRITERIA BASED ON FOUR
CONSIDERATIONS.
WE SAID SWITCH IF YOU START WITH
THE FIRST.
AND IF ALL FOUR CRITERIA MET AT
AT THE TIME FRAME AND HAVE IT
GIVEN IN THE LAST TWO VISITS.
IF THE EYES HAVEN'T VISIBLY
IMPROVED OR THE PATIENT REMAINS
SUB OPTIMAL.
WE HOPE THE SIMPLIFIED MESSAGE
IS EASIER FOR CLINICIANS TO
RETAIN AND REMEMBER TO USE IT.
AND LOOKING AT THE PRACTICE AND
LOOKING AT MACULAR EDEMA AND
RETINOPATHY, I'LL SAY MY VIEW IS
STRENGTHENED WHEN WE GET DIVERSE
INPUT AND THE PROCESS CAN BE
VERY DIFFERENT FROM WHAT YOU END
UP WITH BUT IS A BETTER PROCESS
AND PROCESS FROM THE REVIEW AND
INPUT.
ALGORITHMS NIGHT TO BE ROOTED IN
CURRENT CLINICAL PRACTICE
BECAUSE IT'S DIFFICULT TO GET
FOLKS TO SWITCH OVER TO
SOMETHING THERE'S NO RESEMBLANCE
OF WHAT THEY'RE DOING AS A
SENSIBLE WAY AND NEED TO BE
REMEMBERED AND IMPLEMENTED BY
CLINICIANS.
WE LEARNED THAT OVER THE COURSE
OF OUR STUDIES WHERE WE'LL WRITE
A SECONDARY PAPER DESCRIBING
PHILOSOPHY BEHIND HE'S AND
ADDRESSING SCENARIOS.
IDEALLY TRANSLATABLE FROM LOW TO
HIGH RESOURCE SETTINGS.
ONCE WE HAVE THE PRACTICES, HOW
DO WE EVALUATE WHETHER THEY'LL
BENEFIT PATIENTS?
IT'S NO SURPRISE THERE'S A
HIERARCHY OF EVIDENCE IN
CLINICAL RESEARCH AND WE'LL
SOMETIMES SEE THE EMERGENCE OF
NEW PRACTICES OR INTERVENTIONS
IN CASE REPORTS THERE'S THE
HIGHEST QUALITY OF EVIDENCE WHEN
TALKING ABOUT UNFILTERED DATA
COMING FROM RANDOMIZED CONTROL
TRIALS.
AND WHEN HE YOU LOOK AT THE CARE
FOR EDEMA AND RETINOPATHY
BECAUSE THEY CAN BE EVALUATED.
MACULAR EDEMA WE USUALLY USE A
FIRST-LINE THERAPY AND WE VARY
OUR APPROACH DEPENDING ON THE
VISION AND PATIENTS WITH GOOD
VISION KNOW WE OFTEN FREQUENTLY
OBSERVE THE PATIENTS AND WATCH
THEM AND TREAT IF THE VISION
WORSENS.
AND SOME MEDICATIONS ARE SIMILAR
IN OUTCOMES AND ONE IS SUPERIOR
TO BEVICUZMAB AND IT MAY BE AN
ACCEPTABLE APPROACH AND WHAT
ABOUT DIABETIC RETINOPATHY ?
MANY USE A COMBINATION OF THE
TREATMENTS.
WE ALSO USE VIRTUAL AND SOME
EYES HAVE HAD HEMORRHAGING AND
WITHOUT MACULAR EDEMA MANY OF US
HOLD TREATMENT BECAUSE THERE'S
NOT A VISUAL BENEFIT TO EARLY
TREATMENT BUT WE CAN BE
PREVENTIVE IN NON PROLIFERATIVE
DIABETIC RETINOPATHY AND THERE'S
TREATMENT FOR DIABETIC
RETINOPATHY AND EDEMA AND I WANT
TO POINT OUT I THINK WE ARE
BELIEVED IN THE FIELD IN THAT
ALL OF THESE COMMON WAYS IN
WHICH WE MANAGE PATIENTS HAVE
BEEN INFLUENCED AND IN FACT
OUTLINED BY OUR CLINICAL
STUDIES.
I PUT WHAT IS RELEVANT TO EACH
ASPECT OF CLINICAL CARE BUT WE
HAVE STUDIES AND PERHAPS THE
BEST WAY TO TREAT PATIENTS AS A
WHOLE.
IN THIS STUDY IN THE
OPHTHALMOLOGY SPACE WE'RE
FORTUNATE NOT ONLY DO WE HAVE A
WEALTH OF RANDOMIZED CONTROL
TRIALS TO DIRECT OUR CARE IN
TERMS OF EVIDENCE-BASED
PRACTICES BUT ALSO THE BENEFIT
OF SYSTEMATIC REVIEWS AND
META-ANALYSIS FOR ORGANIZATIONS
LIKE THE COCHRAN GROUP.
THEY HAVE PERFORMED 255 REVIEWS
IN THE OPHTHALMOLOGY SPACE AND
SYSTEMATIC REVIEWS OF DISEASE
AND IT GIVES THE ABILITY TO MOVE
BEYOND AN INDIVIDUAL RANDOMIZED
CONTROL TRIALS THAN TO LOOK AT
SIGNALS ACROSS TRIALS AND
STUDIES AND ARE VALUABLE.
WE HAVE ALL THIS WONDERFUL FROM
THE CLINICAL TRIALS STANDPOINT.
HOW DOES THE COMMUNITY LEARN
ABOUT EVIDENCE-BASED PRACTICES?
THIS IS AN AVENUE FOR
DISSEMINATION AND RESULTS.
FROM A SCIENTIFIC PERSPECTIVE
LOOK AT THE LIST AND PUB
PUBLICATIONS AND SYSTEMIC
REVIEWS AND MANY OF US GET
INVOLVED IN GUIDELINES THAT ARE
DERIVED FROM THE CLINICAL TRIAL
EVIDENCE.
IT'S EASY TO TRACK THE FIRST TWO
THINGS AT PRESENTATIONS AND
PUBLICATIONS WE CAN TELL YOU IN
A MOMENT HOW MANY WE'VE DONE
OVER THE YEARS AND COMING FROM
MANY WAYS AND BROKEN DOWN BY
ASSOCIATED METRICS.
WHAT'S HARDER TO UNDERSTAND IS
HOW INFORMATION IS DISSEMINATED
PARTICULARLY IN THE LAST SET OF
OPTIONS IN TERMS OF PUBLICATIONS
AND PRESS RELEASES, CONTINUING
MEDICAL EDUCATION MEETINGS,
WEBSITES, WEBINARS, SOCIAL
MEDIA.
WE DON'T ALWAYS KNOW HOW
INFORMATION EVEN ABOUT THE
TRIALS WE PERFORMED IS BEING
DISSEMINATED THROUGH THESE
AVENUES AND IT'S CLEAR THE
INFORMATION CAN VARY AND YES
I'LL POINT OUT THAT MANY OF US
IN THE COMMUNITY ARE GETTING A
LOT OF INFORMATION FROM THESE
SOURCES AND IN PARTICULAR OUR
YOUNGER COLLEAGUES IN
OPHTHALMOLOGY ARE TURNING TO
THINGS LIKE PODCAST AND WEBSITE
AND SOCIAL MEDIA FOR THEIR
INFORMATION AND FOR THE
DISCUSSION TO THEN DECIDE HOW TO
TREAT PATIENTS.
THIS CAN YIELD INFLUENCE ON
CLINICAL PRACTICE.
THE CHALLENGES WE HAVE IN
TRACKING INFORMATION
DISSEMINATION AND THEY START TO
SPEAK TO OUR DIFFICULTIES AND
UNDERSTANDING HOW AND WHEN
EVIDENCE-BASED PRACTICES ARE
IMPLEMENTED IN ACTUAL PRACTICE.
SO HOW DO WE KNOW WHETHER OUR
EVIDENCE-BASED PRACTICES ARE
BEING IMPLEMENTED BECAUSE
THEY'RE THE BOAST CHANCE WE HAVE
IN OPTIMIZING VISUAL OUTCOMES
FOR PATIENTS BUT DON'T ALWAYS
KN
KNOW.
THERE'S METHODS TO UNDERSTAND
AND WE CAB RELY ON CERTAIN SICK
AND SURVEY IS AVAILABLE AND A
SURVEY IS A COMMON WAY TO LOOK
AT THE CURRENT PRACTICES AND
THERE'S INFORMATION ABOUT TRENDS
OVER TIME.
IN THE SLIDE I'M SHOWING HERE
I'M SHOWING ANSWERS FROM 2007 TO
2017 TO THE QUESTION HOW DO WE
TREAT A YOUNG PATIENT WITH
DIABETES WHO HAS SEVERE
CLINICALLY SIGNIFICANT MACULAR
EDEMA AND RETINOPATHY.
I WON'T GO INTO DETAIL ABOUT THE
TREATMENT OPTIONS BUT THE GREEN
BARS THAT INCLUDE TREATMENT JUMP
UP DRAMATICALLY OVER THE DECADE
FROM SOMEWHERE AROUND 25%, 30%
IN THE YEAR 2017 AND THE BLUE
BAR WHICH WAS AN OPTION FOLLOWED
BY ADDITIONAL LASER TREATMENT
DECREASES OVER THE YEARS FROM
ABOUT 25%, 30% TO LESS THAN 5%.
WE CAN USE THESE.
THE QUESTIONS ASKED ARE NOT
ALWAYS THE ONES WE WANT TO KNOW
ABOUT AND WE HAVE THE ELECTRONIC
HEALTH RECORD DATABASES AND THE
IRIS REGISTRY AND ELECTRONIC
HEALTH RECORD SYSTEMS.
THIS IS POTENTIALLY A WONDERFUL
RESOURCE AND REPRESENTS
APPROXIMATELY 95% OF
U.S. OPHTHALMOLOGY PRACTICES TO
DATE MANY RECORDED IN THE
DATABASE.
THERE'S BEEN REGISTRIES STARTED
TO DESCRIBE PRACTICE PATTERNS
AND I THINK THERE'S A LOT OF
PROMISE.
THERE'S LIMITATIONS TO THIS
DATABASE WHICH FALL INTO THE
QUESTIONS OF HOW ELECTRONIC
HEALTH RECORD DATA IS NOT
STANDARDIZED AND THE FACT THAT
ANY CLINICAL CARE RECORD WILL
HAVE ISSUES WITH MISSING DATA
AND MESSINESS OF DATA THAT WE
THEN NEED TO FIGURE OUT HOW TO
DEAL WITH OR CLEAN AS WE DRAW
CONCLUSIONS FROM THE DATA ABOUT
SPECIFIC PATTERNS OR CHANGES
OVER TIME.
OTHERS HAVE LOOKED AT DATABASES
AND LOOK TO SEE WHAT'S BEEN
BUILT FOR SPECIFIC PRACTICES
OVER TIME AND PUBLIC HEALTH
REPORTING SYSTEMS AVAILABLE AND
MORE TO DO WITH DIFFERENT
DISEASE THAN PERHAPS COULD BE
USED IN THE IMPLEMENTATION
RESEARCH DOWN THE ROAD.
I MENTIONED THE DRC RETINA
NETWORK AND THE MISSION
STATEMENT.
AND PART OF YOU'RE MISSION IS TO
HOPE WE'RE IMPACTFUL IN RESEARCH
OF OUR RED NAL DISEASES.
DO WE KNOW OUR RESEARCH HAS AN
IMPACT?
WE THINK THERE'S BEEN A DRAMATIC
EVOLUTION IN PART DRIVEN BY THE
NETWORK STUDIES AS WELL AS OTHER
EXCELLENT STUDIES IN THE FIELD.
THEY HAVE CHANGED THE STANDARD
OF CARE FROM LASER TREATMENT IN
2002 WHEN THE NETWORK WAS FORMED
INTO TREATMENT OPTIONS AND
INJECTIONS FOR THE EYE AND WHEN
WE GO TO TRACK, WE KNOW FROM
CONVERSATIONS WITH COLLEAGUES
AND CONVERSATIONS AT MEETINGS
FROM SOME OF THE SURVEYS AND
REGISTRY DATA THAT'S COME OUT, I
PULLED A PARAGRAPH FROM THE
GRANT SUBMISSION BECAUSE THIS IS
A QUESTION WE ASKED, DO RESULTS
ARE THEY IMPLEMENTED AND IMP
IMPACTING CLINICAL CARE.
WE SAID YES THEY WERE.
AND THE WAYS OR EVIDENCE WE KNOW
THEY'RE REFLECTED IN MANY
PRACTICE GUIDELINES FROM
ORGANIZATIONS LIKE AMERICAN
ACADEMY OF OPHTHALMOLOGY AND
COUNCIL OF OPHTHALMOLOGY AND THE
CHAPTER OF THE COURSE RETINA
BOOK WHICH IS THE FOUNDATION OF
THE RESIDENT AND HOW DO WE KNEW
THIS?
BECAUSE THOSE OF US SAT ON THE
COMMIT
COMMITTEES AND PUTTING THESE IN
THE GUIDELINES.
WE SAID THE STUDIES HAVE
PRACTICE GUIDELINES
INTERNATIONALLY FOR MULTIPLE
INTERNATIONAL SOCIETIES
INCLUDING THE UNITED KINGDOM
GROUP AND THE REALITY IS WE WERE
DEPENDENT ON WORTH OF MOUTH AND
LOOK AT PRACTICE GUIDELINES AND
CRDR -- DRCR AND WE WOULD LIKE
TO UNDERSTAND HOW ARE OUR
CLINICAL RESEARCH IMPACTS
CLINICAL CARE AND WHY DO WE NEED
TO KNOW WHAT EVIDENCE-BASED
PRACTICES REPUBLIC IMPLEMENTED?
WE THINK THEY CAN DEFINE GAPS IN
CARE AND THE CYCLE OF RESEARCH
UNDERSTANDING AND STRATEGIES
THAT WE TALKED ABOUT KNOWING THE
PRACTICES WILL HELP DESIGN
FUTURE STUDIES AND TRIALS THAT
CAN ADDITIONALLY EM IMPROVE THE
PRACTICES AND THE DETERMINATION
OF CLINICAL CARE AND PRACTICE
DISSEMINATION ARE ALL INTERWOVEN
EFFORTS OR SHOULD BE THAT CAN
HELP STRENGTHEN EACH OF THE
OTHER AREAS AS WE MOVE THEM
FORWARD.
WHAT ARE OPPORTUNITIES IN THE
SPACE?
I HOPE I'VE SHOWN THE FIELD IS
RICH WITH CLINICAL TRIAL DATA
AND I DON'T THINK IT'S JUST
ALONE FOR DIABETIC RETINAL
DISEASE.
I LOOK AT MY COLLEAGUES IN THE
CORNEA AND GLAUCOMA SEE CLINICAL
TRIAL HAVE DRIVEN CHANGES IN
CARE OVER TIME.
HOWEVER WE LACK COORDINATED
METHODS AND EFFORTS ARE NEEDED
TO DEVELOP EFFORTS.
CONSIDERATION FOR UPTAKE OF
EVIDENCE-BASED PRACTICES.
I THINK IT'S WONDERFUL THE NEI
IS STANDING UP A WORKING GROUP
TO DO THIS ANOTHER OPTION MAY BE
THE CREATION OF A STANDING
INFRASTRUCTURE TO CONSISTENTLY
AND ROUTINE QUERY THE UPTAKE OF
CLINICAL TRIAL FINDINGS.
I'LL BRING US BACK TO THE DRCR
NETWORK AND I WAS THINKING WHAT
WOULD IT BE LIKE TO HAVE AN
IMPLEMENTATION NETWORK OR
COLLABORATIVE EFFORT OVER TIME?
WOULD WE UNDERSTAND THE
IMPLEMENTATION OF OUR PRACTICE
COMES OUT OF THE COUNCIL WORKING
GROUP EFFORTS?
AND DATA SCIENTISTS CAN HELP
DEFINE AND CREATE THE WORKS AND
CARE PROVIDERS AND OTHER
STAKEHOLDERS AND FOUNDATIONS AND
RESEARCH FOR THE BLINDNESS,
AMERICAN DIABETES ASSOCIATION,
MARRY TYLER MOORE VISION NETWORK
AND PATIENTS WITH DIABETES.
OVER THE NEXT 20 YEARS I WOULD
LOVE TO SEE SIMILAR TO HOW WE'VE
SEEN WITH OTHER PIPELINES AND
WHEN HAVE YOU EVERY ASPECT OF
PROPOSAL, IMPLEMENTATION AND
REPORTING, YOU HAVE A LOT OF
EFFICIENCIES IN THAT
INFRASTRUCTURE THAT CAN HELP YOU
MOVE THINGS ALONG EFFECTIVELY.
SO A PIPELINE THAT INFORMS
ONGOING DEVELOPMENT THAT SPARKS
NEW IMPLEMENTATION EFFORTS WITH
THE GOAL OF PERHAPS EXPANDING
BEYOND PERHAPS MY DREAM OF
DIABETIC RETINAL DISEASE EFFORTS
INTO ALL AREAS OF OPHTHALMOLOGY.
I'LL LEAVE YOU WITH THAT VISION.
I'LL SAY HAPPY WORLD SIGHT DAY.
IT WAS YESTERDAY BUT I DO THINK
THIS IS A REALLY FABULOUS
CONVERSATION WITH THE
ACKNOWLEDGEMENT THAT WHEN WE
LOOK AT OUR GLOBAL MAP AND
VISION LOSS BY COUNTRY, IT'S
CLEAR THAT THOUGH WE'RE DOING
RELATIVELY WELL IN U.S. AND
OTHER DEVELOPED COUNTRIES ON A
GLOBAL SCALE THE PREVALENCE OF
VISION LOSS IS ESTIMATED TO BE
AS HIGH AS 20% AND OVER.
AND THIS IS REALLY SOMETHING
THAT WE NEED TO ADDRESS THROUGH
EFFORTS LIKE UNDERSTANDING
IMPLEMENTATION OF BEST PRACTICES
SO WE CAN IMPROVE THOSE PRACTICE
AND WHAT'S BEING PERFORMED IN
CLINICAL CARE TO OPTIMIZE VISION
OUTCOMES FOR ALL PATIENT TO
REDUCE THAT PREVALENCE OF VISION
LOSS TO A RATE OF ZERO PERCENT
IN THE FUTURE.
THANK YOU AND THIS SLIDE SAY
GROUP OF LOGOS OF MANY OF THE
ORGANIZATIONS THAT HAVE
CONTRIBUTED TO EFFORTS IN
DIABETIC RETINAL DISEASE THAT
HAVE BEEN INFLUENTIAL IN THE
AREA AND I END TO EXPRESS MY
GRATITUDE AND TO SAY THAT IN MY
OWN EXPERIENCE THERE'S BEEN A
TREMENDOUS AMOUNT OF
COLLABORATION IN THE SPACE OF
DEVELOPING NEW PRACTICES AND
VALIDATING THEM FOR CLINICAL
TRIAL EFFECTIVENESS OVER TIME
AND GIVES ME HOPE ADDITIONAL
EFFORTS AND HAVE PARTNERSHIPS IN
THIS AREA AND THANK YOU FOR
INVITING ME AND THANK YOU TO THE
NEI COUNCIL FOR YOUR ATTENTION
AND LISTENING AND I'M HAPPY TO
TAKE QUESTIONS.
>>JENNY, THANK YOU VERY MUCH
FOR PUTTING THAT ALL TOGETHER
AND ESPECIALLY FOR YOUR
THOUGHTFUL SYNTHESIS ON THE END
WHERE WE MIGHT BE GOING NEXT.
LET ME OPEN IT UP.
WHAT COMMENTS OR QUESTIONS DO
PEOPLE HAVE?
I THINK YOU RAISED A LOT OF
IMPORTANT ISSUES ABOUT
DISSEMINATE RESEARCH FINDINGS
INTO REAL WORLD PRACTICE.
>>I WILL SAY I WAS PLEASED TO
HEAR FROM RINAD BECAUSE I THINK
WE'RE GOOD AT PUTTING TOGETHER
THE CLINICAL TRIALS BUT I
REALIZED I RAISED MORE QUESTIONS
THAN I ANSWERED.
>>I HAVE EMMY AND THEN
MAUREEN'S HAND'S UP.
>>THAT WAS A TERRIFIC
PRESENTATION.
THANK YOU VERY MUCH.
ONE THING I ALSO WOULD LIKE TO
SAY I FIND IMPORTANT ABOUT THE
ORGANIZATIONS LIKE DRCR, RETINA
NETWORK IS THAT IT TALKS ABOUT
THE IMPORTANCE OF SCIENCE IT
SHOWS THE IMPORTANCE OF SCIENCE
TO NOT JUST ACADEMICS WHO WORK
IN SCIENCE BUT ALSO TO PRIVATE
PRACTITIONERS WHO ARE MAYBE OUT
OF SCIENCE FOR A WHILE AND ARE
INFLUENCED VERY MUCH BY TREATING
A PATIENT, ANECDOTAL EVIDENCE
AND TREATING A PATIENT AND NOT
KNOWING THE LONG-TERM BENEFIT.
IDEAL WITH THIS A LOT IN
PEDIATRIC RETINA BECAUSE THERE'S
RARE DISEASES SO EXPERIENCE IS
IMPORTANT.
THE VALUE OF SCIENCE AND HAVING
CLINICAL TRIALS TO FOLLOW
PATIENTS AND LOOK AT OUTCOMES
LONG-TERM AND HAVE COMPARISON
GROUPS ARE IMPORTANT.
WHEN I WAS ON DRCR NET THERE
WERE TIMES IN THE AUDIENCE WHERE
INVESTIGATORS WOULD SAY, I DON'T
BELIEVE THE DATA.
I THINK IT WAS A GREAT VALUE FOR
PUBLIC HEALTH.
>>THANK YOU FOR THE COMMENT.
I AGREE.
WE KNOW CLINICAL PRACTICE CAN BE
LIKE THE CHILD WEST AND WE STILL
HAVE CONVERSATIONS AS WE PLAN
STUDIES AND RAISE QUESTIONS THAT
ARE SOMETIMES QUITE STRONG
CONVERSATION WITH PEOPLE HAVING
DIFFERENT OPINIONS.
GOING BACK TO THE AND SCIENCE,
AND WE TALK WITH THE TRAINING
GROUND AND WHAT WE FOUND WAS
THAT FREQUENTLY SOME OF THE
SIGNS WILL COME FROM COMMUNITY
AND THE PRACTITIONERS ARE THE
LIFE BLOOD OF THOSE THAT ENROLL
PATIENT AND MAKE THE TRIALS
HAPPEN BUT THERE'S A MASSIVE
BENEFIT IN GETTING A LARGE
NUMBER OF PRACTITIONERS IN
UNDERSTANDING THE DATA BETTER
AND BETTER.
ADDING THEM THE DISCUSSION OF
IMPLEMENTATION ON TO THE
DISCUSSION WE ALREADY HAD WITH
OUR GROUPS ABOUT THE CLINICAL
TRIAL DATA COULD BE A NICE
LEARNING OPPORTUNITY.
>>THANKS, JENNY.
MAUREEN.
>>THANK YOU FOR THE NICE TALK
AND WE'VE BEEN EMPHASIZING I AM
IMPLEMENTATION IN TERMS OF
EDUCATING AND CHANGING THE
PRACTICE OF THE CLINICIANS.
I'D LIKE TO ALSO PAY ATTENTION
TO THE PATIENT.
IN MY AREA, AMD, 25% OF PEOPLE
STOP INJECTIONS AFTER THE FIRST
INJECTION ACCORDING TO SOME
MEDICARE DATA.
REGISTRY DATA OVER TIME 50%, 60%
STOP TREATMENT OVER THE FIRST
FIVE YEARS.
THERE'S RESISTANCE ON THE
PATIENT SIDE TO AND WANT TO MAKE
SURE OUR CLINICIANS ARE
EDUCATING OUR PATIENTS AND WE DO
EVERYTHING POSSIBLE TO HAVE
PATIENTS TAKE ADVANTAGE OF THE
VERY EFFECTIVE TREATMENTS WE
HAVE.
>>IT'S A WONDERFUL POINT.
I COULDN'T AGREE MORE AND A KNOW
YOU WORKED ON PAPERS LOOKING AT
FOLLOW-UP AND WHAT A CHALLENGE
IT IS NOT JUST CLINICAL TRIAL
BUT WE KNOW THERE'S AN ENORMOUS
CHALLENGE IN CLINICAL PRACTICE.
YOU CAN'T IMPLEMENT CARE UNLESS
HAVE YOU THE PATIENT TO BE A
PARTNER IN THAT IMPLEMENTATION.
>>THANK YOU FOR RAISING THAT
ISS
ISSUE.
THERE'S BEEN ORIGIN AND WE
TALKED ABOUT ISSUES LIKE GIVING
THE 200 SOME PRESENTATIONS FROM
DRCR RETINA NETWORK IS AMAZING.
GIVING TALKS ABOUT RESEARCH
SOMETIMES I WONDER AM I TALKING
TO MYSELF OR TALKING TO PEOPLE
LIKE ME WHERE WE AS WE ALL
LEARNED FROM THE PANDEMIC IF IT
WASN'T ALREADY OBVIOUS, HOW MUCH
OF A GAP THERE IS SOMETIMES IN
TERMS OF TAKING SCIENCE AND
TRANSLATING IT INTO REAL WORLD.
I THINK THAT CAME OUT IN YOUR
TALK AND RINAD'S.
I HOPE THAT IN THE DISCUSSION
THAT COMES UP AT THE END OF THE
OPEN SESSION WE CAN TALK ABOUT
WHERE A COUNCIL WORK GROUP MAY
HEAD IN THESE DIRECTIONS AND
WE'LL BE IN TOUCH ABOUT ALL
THIS.
I SEE A HAND UP.
>>AS AS ALWAYS A GREAT
PRESENTATION.
IT'S MORE OF A COMMENT THAN A
QUESTION AS A PRACTICING
PHYSICIAN AS WELL.
THAT'S SCIENCE IS JUST ONE OF
THE CRITICAL BARRIERS TO
PROVIDING OPTIMAL HEALTH TO OUR
PATIENTS AND THERE ARE OTHERS.
WE HEARD THERE'S FINANCIAL ONES
WE FACE ALL THE TIME.
ONE OF THE KEY ASPECTS FOR THE
PHS I'M NOT SURE HOW TO
OPERATIONALIZE MORE EFFECTIVELY
BUT GET THE THIRD-PARTY INSURERS
TO COVER NECESSARY
INTERVENTIONS.
AS A PRACTICING PHYSICIAN WE
OFTEN HAVE TO DELAY THERAPY OR
WAIT FOR INSURANCE COMPANIES TO
ACCEPT PAYMENT OR COVERAGE FOR
APPROVED DRUGS.
IT IMPACTS THE CARE WE PROVIDE
OUR PATIENTS.
THERE'S STILL A BARRIER BETWEEN
DETERMINING THE STANDARDS AND
IMPLEMENTING THEM IN REAL WORLD
AND NEED TO BE ADDRESSED NOR
PATIENTS.
>>WE SEE IT ALL THE TIME.
THE CONVERSATION AROUND STEP
THERAPY IS REFLECTED IN THAT
STUDY.
WE SEE BARRIERS IN TERMS OF
INSURERS DEMANDING OR SAYING
THAT CERTAIN THINGS WILL NOT BE
COVERED BUT WHERE THERE'S LITTLE
EVIDENCE FOR THE OTHERS.
THE SOCIAL DETERMINATES OF WHICH
PATIENTS GET CARE ARE CRITICAL
AS WELL.
>>BEN.
>>THANK YOU, JENNY.
I LIKE THE LAST SLIDE YOU HAVE
THERE.
GETTING DOWN TO ZERO PERCENT
THERE.
IN COUNCIL WE'VE DISCUSSED
SEVERAL TELEHEALTH AND MEDICINE
INTELLIGENCE TO DETECTING
RETINOPATHY.
WHERE DO YOU SEE THE FUTURE AND
HOW SOON DO YOU THINK ALL THIS
CAN BE IMPLEMENTED?
>>I THINK THESE AREAS ARE
PROMISING.
WE'RE USING ARTIFICIAL
INTELLIGENCE AND THE DEVELOPMENT
OF LESS EXPENSIVE CAMERAS THAT
CAN REACH FURTHER OUT IN THE
RETINAL PERIPHERY ARE THINGS I'M
ENTHUSIASTIC ABOUT AND I WAS
THRILLED TO SEE THE BRIDGE TO
A.I. PROJECTS DISCUSSED IN
PARTICULAR THE ONE IN DIABETIC
RETINOPATHY.
WE SEE MANY OF THESE PROJECTS
EVEN KNOW AND WE HAVE
TELEMEDICINE EFFORTS IN
PARTNERSHIP WITH INDIAN HEALTH
SERVICE AS WELL AS CENTERS IN
THE PHILIPPINES IT'S EXCITING TO
SEE THE POTENTIAL REACH OF
TELEHEALTH SCREENING INITIATIVES
THAT MAY NOT JUST BE DEPENDENT
ON THE PATIENT COMING TO THE
MEDICAL CENTER BUT GOING DOOR TO
DOOR AND ASKING PATIENT TO DO
RETINAL SCREENING.
I DON'T THINK IT'S A NEW
APPROACH.
IT'S BEEN AROUND FOREVER AND
THEY WERE DOING THAT IN THE '80s
AS WELL BUT THERE'S SCALABILITY
THE INTELLIGENCE AND EVALUATION
CAN PROVIDE.
WE'RE NOT DEPENDENT ON LOOKING
AT THE IMAGES AND THERE'S HUMAN
VARIABILITY IN THE RATING.
WE'VE SEEN APPROVAL FOR THE
SYSTEMS OF RETINAL DETECTION AND
THERE'S EFFORTS AND I THINK IN
THE NEXT FIVE TO 10 YEARS IS AN
ACHIEVABLE GOAL TO DO THIS ON A
DOUBLE SCALE.
THE QUESTION WILL BE CAN WE GET
THE COLLABORATION ACROSS
STAKEHOLDER GROUPS AND COUNTRIES
TO ADDRESS INEQUITIES IN HEALTH
CARE AND GET THIS TO THE UNDER
SERVED POPULATIONS THAT NEED IT
MOST.
>>CATHY, I HAVE A FEELING WE
NEED TO CLOSE OUT THIS PART OF
THE SESSION BECAUSE OF TIMING.
IS THAT ACCURATE?
>>WE SHOULD PROBABLY GIVE FOLKS
A BREAK.
DOESN'T HAVE TO BE A LONG BREAK.
WE DO HAVE STILL A FULL AGENDA.
SO LET'S TAKE A 10-MINUTE BREAK
AND WHEN WE GET BACK WE'LL
CIRCLE BACK TO THE BUDGET UPDATE
WHICH IS ALWAYS OF MOST INTEREST
I THINK TO PEOPLE AND VERY
INTERESTING.
WE'LL DO THAT WHEN WE COME BACK
AT 10 TO 1:00.
IS THAT OKAY?
KAREN.
>>THAT'S FINE.
THANK YOU.
>>GREAT.
I'LL SEE EVERYBODY THEN.
THANK YOU EVERYBODY FOR A NICE
DISCUSSION.
>>WE'RE A LITTLE BIT
OFF SCHEDULE SO KAREN WILL GET
THE BUDGET OVERVIEW WHICH WE
DIDN'T GET TO EARLIER IN THE DAY
SO YOUR PRESENTATION WILL BE
SHIFTED YOURS AND MARYANN'S
SHIFTED A BIT.
KAREN, GO AHEAD.
>>GOOD AFTERNOON, EVERYONE.
IT'S NIS TO BE WITH YOU ON THIS
BEAUTIFUL FALL DAY TO SHARE THE
BUDGET UPDATE.
I'LL START WITH A RECAP OF HOW
WE ENDED LAST FISCAL YEAR WHICH
CONCLUDED AND SHARE THE BUDGET
THAT STARTED OCTOBER 1.
AS YOU KNOW, THE VAST MAJORITY
OF THE BUDGET IS SPENT ON
EXTRAMURAL PROGRAMS.
THIS SLIDE REPRESENTS NEI
SPENDING FOR THE FISCAL YEAR
THAT JUST ENDED.
I'LL SAY THAT UNTIL OUR DATA IS
APPROVED BY CONGRESS IT'S AN
ESTIMATE BUT IT'S A GOOD
REPRESENTATION OF HOW WE ENDED
THE FISCAL YEAR.
ON THE LEFT IS A PIE CHART THAT
DIVIDES SPENDING INTO FUNDING
CATEGORIES WITH THE PERCENTAGE
RELATIVE TO THE TOTAL NEI
BUDGET.
THE LARGEST SLICE IS FOR
RESEARCH PROJECT GRANTS AT 63%
OF THE BUDGET THEN WE HAVE
RESEARCH CENTERS AT 3% OF THE
BUDGET OTHER RESEARCH AT 10%
TRAINING GRANTS AT 2% AND
RESEARCH AND DEVELOPMENT
CONTRACT AT 5 PACIFIC AND
RESEARCH SUPPORT AT 5%.
TO THE RIGHT IS A BAR CHART THAT
GIVES A HIGHER LEVEL LOOK AT THE
MAJOR FUNDING MECHANISMS,
EXTRAMURAL RESEARCH INTRAMURAL
RESEARCH AND RESEARCH SUPPORT
AND EXTRAMURAL RESEARCH IS A
COMBINATION OF THE GRANT
ACTIVITIES AND RESEARCH AND
DEVELOPMENT CONTRACTS WHICH
COMBINED MAKE UP A TOTAL OF 83%
OF THE TOTAL NEI BUDGET.
THEN OF COURSE WE HAVE
INTRAMURAL RESEARCH AND SUPPORT.
THESE FUNDING LEVELS ARE TYPICAL
OF WHAT WE SEE IN A GIVEN FISCAL
YEAR AND HAVE REMAINED
CONSISTENT OVER TIME.
NOW WE MOVE IT ON THE BUDGET FOR
THE CURRENT YEAR.
WE'RE OPERATING UNDER WHAT'S
CALLED A CONTINUING RESOLUTION.
AND THIS CURRENT RESOLUTION IS
EFFECTIVE THROUGH DECEMBER 16.
WE CALL THOSE CR.
A CR IS SHORT-TERM LEGISLATION
THAT AVERTS GOVERNMENT SHUTDOWN
AND GIVES US THE OPPORTUNITY TO
OPERATE UNTIL CONGRESS GIVES THE
BUDGET FOR THE CURRENT FISCAL
YEAR.
A C.R. CAN BE PUT IN PLACE FOR
DAYS, WEEKS, MONTHS OR A FULL
FISCAL YEAR.
THE CURRENT C.R. GIVES CONGRESS
MORE TIME TO COMPLETE THEIR WORK
OF PROVIDING APPROPRIATION FOR
THE YEAR.
WHEN WE ARE UNDER C.R. WE DO NOT
RECEIVE OUR FULL BUDGET FOR THE
YEAR.
WE RECEIVE FUNDING BASED ON THE
NUMBER OF DAYS IN THE BILL.
FOR EXAMPLE THROUGH DECEMBER 16
IT REPRESENTS 77 DAYS OF THE
FISCAL YEAR AND GIVES 21.1% OF
WHAT OUR BUDGET WAS IN FY2022 TO
OPERATE WITH.
ONE OF THE FACTORS IMPACTING THE
TIMING OF WHEN WE MAY RECEIVE A
BUDGET THIS YEAR IS THE MIDTERM
ELECTIONS IN NOVEMBER.
WE'LL NOD HAVE ADDITIONAL
INFORMATION ABOUT THE BUDGET
UNTIL THOSE ELECTIONS ARE OVER.
WE KNOW THERE'S NO EXPECTATION
OF HAVING TO OPERATE UNDER
CONTINUING RESOLUTION FOR THE
FULL YEAR THAT'S IMPORTANT TO
KNOW BECAUSE A C.R. HOLDS US AT
THE APPROPRIATION FOR THE
PREVIOUS FISCAL YEAR.
SO IF WE WERE TO TO HAVE TO
MANAGER OUR PROGRAMS THAT'S
EFFECTIVELY A CUT BECAUSE OF OUR
MANDATORY COSTS WILL INCREASE.
WHEN THIS CURRENT C.R. EXPIRES
IN DECEMBER IT'S LIKELY WE'LL
SEE ADDITIONAL SHORT-TERM C.R.s
AS CONGRESS FIGURES OUT THE PLAN
TO PROGRESS TO COMPLETE THE
BUDGET PROCESS.
AFTER THE ELECTIONS IN NOVEMBER,
CONGRESS WILL COME UP WITH A
PLAN TO MOVE FORWARD TO GIVE US
OUR APPROPRIATION.
THERE IS SPECULATION THE OUTGOM
GOING MEMBERS MAY PUSH THE
PROCESS ALONG TO TAKE CARE OF
THAT BEFORE THEY LEAVE.
FOR NOW WE WAIT WITH FULL
EXPECTATION CONGRESS WILL
PROVIDE AN OMNIBUS BILL TO FUND
US FOR THE CURRENT FISCAL YEAR.
TO EXPLAIN WHAT AN OMNIBUS BILL
IS, IT'S ESSENTIALLY MULTIPLE
BILLS FOR DIFFERENT GOVERNMENT
AGENCIES OR DEPARTMENTS
CONSOLIDATED AND VOTED ON AS A
PACKAGE VERSUS SEPARATELY AS IS
THE TRADITIONAL PROCESS.
THE TRADITIONAL PROCESS HAS 12
DIFFERENT APPROPRIATION BILLS
THAT NEED TO BE PASSED EACH YEAR
TO FUND THE GOVERNMENT AND AVOID
SHUTDOWN BUT AN OMNIBUS BILL
GETS US TO THE FINISH LINE WHEN
THE 12 APPROPRIATIONS ARE NOT
PASSED INDIVIDUALLY.
THIS SLIDE COMPARES FUNDING
LEVELS '21, '22, AND '23.
FOR 2023 WE HAVE THE PRESIDENT'S
BUDGET REQUEST AT $853.3 MILLION
RELEASED LAST WINTER.
THE HOUSE AND SENATE LEVELS IN
THE SPRING AND SUMMER ARE $891.2
MILLION AND $890 MILLION
RESPECTIVELY.
THE SLIDE SHOWS THE
APPROPRIATION AND BUDGET
AUTHORITY AS YET TO BE
DETERMINED AND TELL YOU THE
DIFFERENCE BETWEEN BUDGET
AUTHORITY AND APPROPRIATION.
THE BUDGET AUTHORITY IS OUR
APPROPRIATION MINUS TRANSFERS
OUT OF OUR BUDGET INITIATED BY
NIH THE DEPARTMENT OF HEALTH AND
HUMAN SERVICES OF WHICH HINIH IA
DIVISION AND THE BUDGET
AUTHORITY WILL BE AMOUNT IN HAND
TO FUND OPERATIONS FOR THE YEAR.
THE PRESIDENT'S BUDGET REQUEST
IS SOMETHING THAT'S PUBLIC AND
SO I WANTED TO PROVIDE A LITTLE
BIT OF CONTEXT FOR THAT REQUEST.
THE FY2023 BUDGET REQUEST IS
LOWER THAN WHAT THE HOUSE AND
SENATE HAS PROPOSED FOR THIS
YEAR BUT FIRST AND FOREMOST IT'S
A PLANNING DOCUMENT AND DOES NOT
ESTABLISH APPROPRIATIONS.
I'LL MENTION THAT THE 2023 PB
LEVEL WAS LOW BECAUSE WHEN IT
WAS DEVELOPED WE DID NOT HAVE
THE 2022 APPROPRIATION.
BECAUSE OF THAT THE BUDGET
NUMBER USED FOR THE BASE ASSUMED
A FULL YEAR CONTINUING
RESOLUTION WHICH HELD THE SAME
FUNDING LEVEL AS FISCAL YEAR
2021 APPROPRIATION.
SO WHEN WE RECEIVE THE
APPROPRIATION FOR FISCAL 2022
THERE WAS A SIGNIFICANT INCREASE
ABOVE THE LEVEL FROM THE 2022
PRESIDENT'S BUDGET.
RIGHT NOW WE'RE UNDER SIMILAR
CIRCUMSTANCES AND STARTING TO
WORK ON THE FISCAL YEAR 2024
PRESIDENT'S BUDGET REQUEST
WITHOUT A CURRENT APPROPRIATION
IN PLACE.
MUCH OF THE PROCESS IS TO BE
DERMED SO EVERYTHING HINGES ON
THE RESULT OF THE NOVEMBER
ELECTION AND THE HOUSE AND
SENATE PROPOSED APPROXIMATELY 3%
INCREASE FOR NEI.
THE HOUSE AND SENATE WILL STILL
HAVE TO GO INTO CONFERENCE AND
OUR BUDGET COULD BE HIGHER, IT
COULD BE LOWER BUT AT THIS POINT
WE WAIT AND SEE.
FINALLY HERE ARE HIGHLIGHTS OF
HOUSE AND SENATE BILLS THAT
SPEAK TO FUNDING AT THE NIH
LEVEL.
THE HOUSE PROPOSED A $2.5
BILLION INCREASE FOR NIH
EXCLUDING ARPA-H THE ADVANCED
RESEARCH PROJECTS AGENCY FOR
HEALTH WHILE THE SENATE PROPOSED
A $2 BILLION INCLUDING NIH BUT
AT THE SAME FUNDING LEVEL AS
LAST YEAR WHICH IS $1 BILLION.
ALSO INCLUDED IN THE SENATE BILL
IS A MINIMUM 3% INCREASE FOR
MOST NIH INSTITUTES AND CENTERS
WITH SOME I.C.s RECEIVING
TARGETED INCREASES FOR SPECIFIC
PRIORITIES INCLUDING OPIOIDS
RESEARCH, HEALTH DISPARITIES AND
ENVIRONMENTAL HEALTH.
THAT CONCLUDES MY UPDATE AND
HAPPY TO ANSWER QUESTIONS.
THIS IS MY CONTACT INFORMATION.
IF YOU HAVE QUESTIONS ABOUT THE
BUDGET CONTACT ME AT ANY TIME.
THANK YOU.
>>DOES THE NIH DO WE HAVE
LOBBYISTS?
HOW MANY LOBBYISTS DO WE HAVE
AND WHAT'S THE PROCESS?
I WOULD REFER TO SHEPPA GORDON.
>>CAN YOU HEAR ME?
WE AS FEDERAL EMPLOYEE NOT TO
LOBBY.
THERE ARE VARIOUS GROUPS THAT
WILL LOPY ON BEHALF OF NIH SO
THERE'S AN AD HOC GROUP AND
THERE'S A GROUP OF DIFFERENT
INTERESTING ORGANIZATIONS LIKE
UNIVERSITIES OR PATIENT ADVOCACY
GROUPS AND UNDER ONE BIG
UMBRELLA THEIR GENERAL POLICY IS
THEY DON'T WANT TO PICK ONCE
AGAINST THE OTHER.
THEY LOBBY ON BEHALF OF ALL OF
NIH.
THERE'S ALSO A FRIENDS OF NEI
GROUP FOR EYE AND VISION
RESEARCH.
THEY DO EDUCATION ACTIVITIES FOR
MEMBERS OF CONGRESS AND A SECOND
GROUP LOBBYING AND EDUCATE
CONGRESS ON WHAT NEI IS DOING
AND WHAT WE COULD DO WITH MORE
RESEARCH
>>THANK YOU VERY MUCH AND BEN
THANKS FOR ASKING.
KAREN, THANK YOU FOR THE
PRESENTATION.
>>ABSOLUTELY.
THANK YOU.
>>CATHY, DO WE TURN BACK TO
YOU?
>>THANK YOU.
I APPRECIATE YOUR COMPLEXABILITY
WITH THE SCHEDULING.
SO WHAT WE HAVE NEXT ON THE
AGENDA IS SOMETHING WE HAVE BEEN
DOING FOR THE PAST COUPLE OF
MEETINGS, WE ARE GOING TO HAVE
TWO PORTFOLIO OVERVIEWS.
ONE FROM THE COLLABORATIVE
CLINICAL RESEARCH PROGRAM THAT
SUPPORTS MOST OF THE CLINICAL
TRIALS NEI SUPPORTS AND WE
THOUGHT THAT WOULD BE GOOD TO
HEAR ABOUT GIVEN WE JUST HEARD
ABOUT THE DCRC AND THE
IMPORTANCE OF IMPLEMENTATION
RESEARCH AND WHAT THAT IS.
AND DR. MARYANN REDFORD WILL
TALK WITH THE PROGRAM THAT
SUPPORTS NEI CLINICAL TRIALS.
MARYANN, GO AHEAD AND TAKE IT
AWAY.
>>I'M HAPPY TO PROVIDE THE
OVERVIEW OF THE COLLABORATIVE
CLINICAL RESEARCH PROGRAM WHICH
I THINK COUNCIL WILL HEAR IF IT
DOESN'T ALREADY APPRECIATE THAT
IT'S APTLY NAMED.
WE WORKED CLOSELY AND WITH OUR
INVESTIGATIVE TEAMS TO MANAGER
THE PORTFOLIO.
THE FOUR OF US ARE IN DAILY
CONTACT AND COLLECTIVELY BRING
103 YEARS OF NIH EXPERIENCE TO
THE TABLE WE SUPPORT THE
INSTITUTE'S PHASE 3 TRIALS AND
GENE AND CELLULAR THERAPY TRIALS
AND TWO RESEARCH NETWORKS,
MULTI-SITE EPIDEMIOLOGIC STUDIES
AND SYSTEMATIC REVIEW.
THE PORTFOLIO IS HEAVILY EXUDE
TOWARDS THE U MECHANISM.
NIH UTILIZES COOPERATIVE
AGREEMENTS WHEN IT ANTICIPATE
SUBSTANTIAL STAFF INVOLVEMENT
AND DIRECTORS PARTICIPATE IN
DISCUSSION AND TAKE PART IN
STEERING AND OVERSIGHT COMMITTEE
MEETINGS.
IN THAT WAY WE'RE ABLE TO TAKE
THE PULSE OF OUR STUDIES IN REAL
TIME AND PROVIDE THE KINDS OF
STEWARDSHIP IS THE PROFILE THE
COMPLEX PROJECTS DESERVE.
I MENTIONED THE EXTENSIVE OF OUR
GROUP.
OUR SUPER POWER IS OUR ABILITY
TO LEVERAGE THE EXPERIENCE AND
EXPERTISE OF PEOPLE WHO SERVE ON
OUR MONITORING COMMITTEES FOR
CLINICAL TRIALS COMMITTEES AND
FOR EPIDEMIOLOGIC STUDIES AND
THEY ASSIST NEA IN PROTECTING
RESEARCH PARTICIPANTS AND
MONITORING QUALITY, TIMELINESS
AND INTEGRATE.
-- INTEGRITY.
THE BAR IS SET VERY HIGH.
THIS STARTS AT THE APPLICATION
PHASE.
ALL CCR COOPERATE AGREEMENT
STUDIES MUST RESPOND TO NEI
SPECIFIC FUNDING OPPORTUNITY
ANNOUNCEMENTS WHICH ELICIT
DETAILS ON THE STUDY DESIGN AND
IMPLEMENTATION.
THESE APPLICATIONS ARE REVIEWED
IN HOUSE BY NEI CONVENED SPECIAL
EMPHASIS PANEL AND OUR SROs GO
TO GREAT LENGTHS TO ENSURE
RIGOROUS REVIEW.
OUR CLINICAL RESEARCH COMMUNITY
MAKES GOOD USE OF OUR SECONDARY
DATA ANALYSIS AND PLANNING
OPPORTUNITIES AND SOME SMALL
LESS COMPLEX STUDIES COME TO CCR
TO DO THE PARENT RO1.
WE'RE EXCITING TO SUPPORT
STUDIES WITH CUTTING EDGE
STUDIES IN HUMANS AND PROSTHESIS
AND STEM CELL AND INTERVENTIONS
AND TWO STEM CELL STUDIES ARE
BEING SUPPORTED BY THE
GENERATIVE MEDICINE INNOVATION
PROJECT.
ONE WAS TO ACCELERATE PROGRESS
IN THE FIELD A TRANS-NIH
INITIATIVE AND APPLICATIONS
COVER THE SCOPE OF SCIENCE
ACROSS ALL NIH DISCIPLINES AND
YET IN THE LAST FUNDING ROUND,
THREE APPLICATIONS WERE SELECTED
AND TWO WERE I- WE SUPPORT A
WIDE ARRAY OF CLINICAL TRIALS
ACROSS THE UNITED STATES.
THESE PLAY A CRITICAL ROLE
ADDRESSING ISSUES WHERE THE
PRIVATE SECTOR WOULDN'T GO.
NEA HAS A SOPHISTICATED RESEARCH
COMMUNITY AND SCIENTISTS,
TRIALISTS AND EPIDEMIOLOGISTS
AND ALL COLLABORATE TO EXECUTE
HIGH QUALITY STUDIES.
OUR DISCIPLINE ALSO STANDS OUT
AND MOST STUDIES USE ACADEMIC
AND PRIVATE PRACTICE BASED
ENROLLMENT CENTERS.
WE'RE SEEING AN UPTICK IN
INTERNATIONAL SITE
PARTICIPATION.
THIS ENHANCES ENROLLMENT, MAKES
THE TRIAL MORE REAL WORLD AND
ACCELERATES THE TRANSLATION OF
RESEARCH TO PRACTICE.
TAKEN TOGETHER THE ANTERIOR
SEGMENT AND BACK OF THE EYE AND
ADDRESSES IMPORTANT ISSUES
INCLUDING A AND D IN OLDER
INDIVIDUALS AND RETINOPATHY OF
PREMATURITY.
AND WE HAVE GOOD OF WOMEN AND
MINORITIES.
WE ALSO HEARD THERE'S A NEED AND
NEI IS ADDRESSING THAT WITH TWO
INTERNATIONAL RESEARCH PROJECTS
IN COUNTRY PUBLIC HEALTH
FOCUSSED STUDIES BEING CONDUCTED
IN ETHIOPIA AND NEPAL AND NIGER.
THEY COME WITH THEIR OWN
CHALLENGES UNIQUE SET OF
CHALLENGE BUT THANKFULLY NEI HAS
A CADRE OF EXPERIENCED
INVESTIGATORS PASSIONATE ABOUT
THE WORK.
WE SUPPORT TWO RESEARCH NETWORKS
AND YOU'VE BEEN INTRODUCED TO AT
LEAST ONE.
AND BOTH RESEARCH NETWORKS ARE
OPEN WHICH AGAIN I THINK IS A
UNIQUE ASPECT OF NEI SUPPORTED
RESEARCH.
THAT MEANS ANYONE QUALIFIED AND
ABLE TO ENROLL AND EXECUTE THE
PROTOCOL CAN PARTICIPATE.
YOU HEARD ANYONE CAN SUGGEST
RESEARCH IDEAS FOR CONSIDERATION
AND SCIENTIFIC CONTRIBUTIONS CAN
PARTICIPATE IN THE MANUSCRIPT
WRITING PROCESS.
THE PEDIATRIC EYE DISEASE
INVESTIGATIVE STUDIES HAVE
INFLUENCED CLINICAL PEDIATRIC
CARE WORLDWIDE.
300 OPHTHALMOLOGISTS ARE ENGAGED
IN RESEARCH AND 130 MANUSCRIPTS
HAVE BEEN PUBLISHED AND THERE'S
EVIDENCE-BASED PREFERRED
PRACTICE FOR AMBLIOPIA.
YOU'VE HEARD ABOUT THE DRCR
RETINAL NETWORK AND I'LL DIVERGE
FROM WHAT I HAD PLANNED TO SAY.
THE PUBLICATION JUST HIT THE
PRESS IN 2022 AND THAT GIVES YOU
THE IDEA -- THAT'S TRUE FOR ALL
HER STUDIES.
THE PLANNING AND LAG TIME, IF
YOU HAVE A PRIMARY OUTCOME OR
FOUR-YEAR PRIMARY OUTCOME,
WHATEVER IT IS, YOU'RE NOT
PUBLISHING THE RESULTS OF YOUR
STUDY UNTIL YOU HIT THAT.
KEEP THAT IN MIND WHEN YOU HEAR
THE NUMBERS.
THE OTHER THING SHE SAID WAS
INTERESTED SHE NOTED 398
PRACTITIONERS INVOLVED IN THE
RESEARCH BUT THEY WERE 1,000
OTHER PERSONNEL ENGAGED IN
RETINA RESEARCH.
THE CLINICIANS ARE VERY
IMPORTANT OF COURSE.
BUT THERE'S A WHOLE TEAM BEHIND
EVERY ENROLLMENT CENTER P.I.
THERE'S A TEAM SUPPORTING THAT
RESEARCH SO THERE'S STUDY
COORDINATORS AND A GOOD STUDY
COORDINATOR IS WORTH THEIR
WEIGHT IN GOAL.
MOST STUDIES HAVE IMAGING.
THERE'LL BE OCT TECHNICIANS AND
IT TAKES A VILLAGE.
ALL THE STUDIES ARE ROUTINE
RESEARCH.
AN THERE'S COLLABORATIONS DRCR
HAS ALREADY AFFECT ED THE
COLLABORATION BETWEEN NEI AND
NIDDK AND GARNERED THE SUPPORT
OF PARTNERS.
IT'S HARD TO OVER EMPHASIZE THE
INFLUENCE THE NETWORK STUDIES
HAVE HAD ON CLINIC PRACTICE AND
THE ALGORITHMS ARE REMREFLECTED
GUIDELINES AND THE AMERICAN
DIABETES ASSOCIATION AND THE
INTERNATIONAL COUNCIL IN
OPHTHALMOLOGY.
IT'S FITTING AS WE ROUND OUT
HISPANIC HERITAGE MONTH THERE'S
A STUDY THAT'S PIGGY BACKED TO
THE NHLBI HISPANIC COMMUNITY
HEALTH STUDIES.
IT WILL BE ABLE TO LEVERAGE HIGH
QUALITY PHENOTYPIC AND GENOTYPIC
DATA AND CONDUCTING EYE EXAMPLES
ON PARTICIPANTS IN CHICAGO AND
MIAMI.
AND IT REPRESENTS A UNIQUE
OPPORTUNITY TO RELATIONS AMONG
EYE CONDITIONS AND NOVEL
CARDIOVASCULAR DISEASE, OTHER
SOCIAL CULTURAL RISK FACTORS AND
MANY KNOW THE COLLABORATION IS
AN INTERNATIONAL ORGANIZATION
WITH THE GOAL OF HELPING PEOPLE
MAKE INFORMED DECISIONS ABOUT
HEALTH CARE.
COCHRANE EYE USES IT TO
SYNTHESIZE THE LITERATURE AND
EXPAND THE EVIDENCE BASE FOR EYE
CARE.
WITH THAT I'LL WRAP IT UP.
I KNOW IT WAS A HIGH-LEVEL
OVERVIEW BUT BEFORE I DO I WANT
TO DO A SHOUT OUT AS DON EVERETT
ALWAYS REMINDS US, WE HAVE A
GOOD STORY TO TELL AND THAT'S
TRUE FOR OUR STUDIES AND
INVESTIGATIVE GROUPS.
THIS IS FOR MEMBERS OF THE
OCULAR HYPER TREATMENT STUDY.
IN A RECENT RANKING FROM THE
AMERICANS AMERICAN GLAUCOMA
STUDY AND THOSE WITH IMPACT ON
CLINICAL GLAUCOMA CARE THEY
GARNERED THE NUMBER ONE, TWO AND
THREE RANKING.
CONGRATULATIONS TO EVERYONE WHO
WAS INVOLVED IN THOSE AND MY
CAST AND YOU NOT ONLY TOOK HOME
THE BRONZE, THE SILVER AND THE
GOLD.
THANK YOU.
QUESTIONS, COMMENTS?
I DIDN'T KNOW IF YOU WANTED TO
SAY A FEW WORDS?
>>I'VE HAD THE PRIVILEGE ON
SERVING ON BOTH SIDES OF THE
TABLE, CONDUCTING COLLABORATIVE
STUDIES I THINK ARE DONE AT SUCH
A HIGH LEVEL BECAUSE WE WERE
ABLE TO BRING IN THE BEST PEOPLE
FROM MANY DIFFERENT DISCIPLINES.
THAT'S BEEN WONDERFUL AND THE
PRESENTATIONS SHOWING THE NUMBER
OF PUBLICATIONS AND THE
INFLUENCE OF THE STUDIES HAVE
REALLY DEMONSTRATED THE VALUE OF
THESE VERY EXPENSIVE STUDIES AND
FROM THE OTHER SIDE WE HAVE
GREAT DIVERSITY OF EXPERTISE AND
I THINK IT'S ALWAYS GOOD TO HAVE
PEOPLE TO STEP AWAY FROM THE
STUDIES AND GIVE ADVICE AND MAKE
SURE EVERYTHING'S RUNNING AS
WELL AS IT CAN.
VERY NICE PRESENTATION, MARYANN.
>>THANK YOU.
>>THANK YOU AND I CONGRATULATE
YOU FOR ALL YOU AND YOUR
COLLEAGUES HAVE DONE AT THE NEI
TO SUPPORT THESE STUDIES MANY OF
WHICH ARE NOT TOP CANDIDATES FOR
INDUSTRY SUPPORT.
THEY'RE LENGTHY AND THEY'RE
REPORTING QUESTION TAKE A LONG
TIME TO GET ANSWERS ON AND FOR
OBVIOUS REASONS INDUSTRY CANNOT
MAKE INVESTMENTS INTO THE
QUESTIONS BECAUSE OF THEIR
NATURE.
YOU FILL AN IMPORTANT NICHE SO
THANK YOU.
>>AND REZA DOES A STUDY FOR
LIMBAL EPITHELIAL STEM CELL AND
THE FIRST STAGE WORK OUR
INVESTIGATORS NEED TO OVERCOME
ARE REALLY LENGTHY AND WITHOUT
INFRASTRUCTURE SUPPORT TO
FACILITATE THE RESEARCH.
SHE WAS ABLE TO LEVERAGE
OPPORTUNITIES TO DO THE
PRELIMINARY PRECLINICAL WORK AND
THAT WAS IMPORTANT.
>>I WAS CURIOUS ABOUT THE SOL
OJOS PROJECT.
HOW IS THAT REACHING POPULATIONS
ALREADY DIFFICULT TO REACH FOR
THE STUDIES?
>>WE'RE LEVERAGING WHAT NHLBI
HAS PUT INTO PLACE AND IT'S NOT
THE EYE COMPONENT BUT A
LONGITUDINAL STUDY AND THEY WENT
TO GREAT LENGTHS TO GET DIVERSE
POPULATIONS OF LATINAS TO
PARTICIPATE WE'RE BENEFITING NOT
ONLY ON THAT DATA BUT ON THE
WORK THEY DID TO MAKE THE
COHORT.
>>DO WE KNOW WHAT THE
IMPLEMENTATION PLANS ARE AND
WHAT THEY'LL DO WITH THE DATA
AFTER THEY GET THE DATA AND HOW
IT WILL BE IMPLEMENTED TO
IMPROVE THE VISION OF THESE
COMMUNITIES?
>>THERE'S A PLANNED AIM OF THAT
WORK BUT I THINK IN THE EYE
FIELD, WE'RE LOOKING TO SEE THE
CONDITIONS.
RIGHT NOW THEY'RE DOING 3,000
COMPREHENSIVE EYE EXAMS AND
INTERESTED IN SEEING HOW THAT
CORRELATES WITH THE SYSTEMIC
DATA AND GENETIC DATA THAT'S
AVAILABLE.
YOU'RE RIGHT, AND WE HAVE
DISPARI
DISPARITIES.
>>DO YOU HAVE A QUESTION?
>>I'M SORRY.
>>I HAVE A COMMENT.
I GUESS THE COMMENT TO
IMPORTANCE OF THAT TRIAL FOR THE
OCULAR STUDY AND THE RESOURCE
HELPED TREMENDOUSLY AND HOPE TO
RESOLVE MANY DIFFERENT ISSUES.
I'M SURPRISED IT WAS THE FIRST
ONE.
I HAVEN'T SEEN A PAPER ABOUT THE
PRESSURE BUT IT DOES NOT MENTION
THE PAPER.
>>YES, I THINK IT WAS WONDERFUL
THEY GOT THAT RECOGNITION AND
FRANKLY IN THE TOP 10 OR
WHATEVER RANKINGS, THERE WERE A
NUMBER OF NEI SUPPORTED GLAUCOMA
TRIALS AND IT WAS NOT JUST THEY
GOT THE TOP THREE.
>>THANK YOU.
>>THANK YOU, MARYANN.
>>OUR NEXT PORTFOLIO IS ONE WE
HAVE PRESENTED EVERY FALL AND IT
INCLUDES SOME THINGS WE'RE
REQUIRED TO PRESENT TO YOU SO
OUR TRAINING OFFICER IS GOING TO
PRESENT AN OVERVIEW OF THE NEI
TRAINING PORTFOLIO.
GOOD AFTERNOON AND THANK YOU FOR
DOING SUCH A GOOD JOB.
AND THERE'S INDIVIDUAL
FELLOWSHIPS AND F31 IS A
FELLOWSHIP FOR GRADUATE STUDENTS
ENROLLED IN Ph.D. PROGRAM AND
F32 IS A POSTDOCTORAL
FELLOWSHIP.
WHEREAS THE CAREER DEVELOPMENT
PROGRAM CONSISTS OF K08 AND A
WARD FOR BASIC DIDACTIC
RESEARCH.
K23 IS AN AWARD FOR CLINICALLY
ORIENTED RESEARCH.
THOSE PEOPLE WHO WILL BE
CARRYING OUT WHAT MARYANN
ALLUDED TO AND K99/R00 IS A
TRANSITION AWARD FOR POSTDOCS
AFTER FINISHING Ph.D. AND HAVING
SAID THAT, EVEN CLINICAL
SCIENTISTS ARE ELIGIBLE TO APPLY
FOR THIS PROGRAM.
FINALLY, WE HAVE INSTITUTIONAL
TRAINING GROUNDS, T32 IS
INSTITUTIONAL TRAINING GROUND
FOR PRE AND POSTDOCTORAL
STUDENTS AND T35 IS A PROGRAM
FOR MAINLY MEDICAL STUDENTS
BETWEEN FIRST AND SECOND YEAR OF
THEIR SUMMER AND FIRST YEAR OF
SUMMER BEFORE STARTING SECOND
YEAR.
AND K12 IS THE CAREER
DEVELOPMENT PROGRAM FOR
CLINICIAN SCIENTISTS.
ONE HAS TO BE A U.S. CITIZEN TO
APPLY FOR INDIVIDUAL FELLOWSHIPS
AS WELL K08 AND K23.
BUT FOR K99 AND R00 ONE DOESN'T
HAVE TO BE A RESIDENT.
NOW, GOING ON I'LL BE USING
THESE NOMENCLATURE AT 30 AND
30K08 AND IF YOU HAVE CONFUSION,
RAISE YOUR HAND AND I'LL BE ABLE
TO ANSWER YOU BUT I'LL TRY TO
KEEP IT STRAIGHT.
ALL RIGHT.
SO THIS SLIDE SHOWS AND THERE'S
A PREDOC FELLOWSHIP FOR
CLINICIAN SCIENTISTS AND Ph.D.
STUDENTS AT 31 IS THE PREDOM
FELLOWSHIP FOUR GRADUATE
STUDENTS INVOLVING Ph.D. PROGRAM
AND K08, K23 AND K99 ARE CAREER
DEVELOPMENT AND CAREER
TRANSITION AWARD.
T32 IS THE INSTITUTIONAL
TRAINING GROUND FOR PRE AND POST
DOCK AND T35 IS THE
INSTITUTIONAL TRAINING GROUND
FOR SHORT TERM TRAINING AND K12
IS THE INSTITUTIONAL TRAINING
FOR CAREER DEVELOPMENT
SCIENTISTS.
THIS IS THE DISTRIBUTION.
THE RESEARCH PROGRAMS ARE
DIVIDED INTO RETINA, CORNEA,
GLAUCOMA AND VISUAL PROCESSING
AND LOW VISION.
THESE SIX PERHAPS.
SO HERE I'M COMPARING MY
PORTFOLIO AND HOW THEY ARE
DISTRIBUT
DISTRIBUTED AMONG THE RESEARCH
PROGRAMS.
YOU SEE HERE THE BLUE PART OF
THE PIE 43% FOR FELLOWSHIPS AND
44% FOR THE OTHER SERVICE AND
THE OTHER IS MYOPIA AND VISUAL
PROCESSING IS HALF AND SAME TO
THAT OF RETINA.
IN THE CASE IT'S HALF THE REST
OF THE PROGRAMS ARE CONSISTING
OF 10% OF THE RESEARCH PROGRAM
FOR NEI.
THIS SLIDE SHOWS THE SUCCESS
RATE OF FELLOWSHIPS?
HOW DO YOU CALCULATE IT?
YOU LOOK AT THE AWARDED
FELLOWSHIPS COMPARED TO THE
FELLOWSHIPS AND YOU GO 100
APPLICATIONS AND WE FUNDED 50 SO
THE RATE IS 50%.
HERE WE CALCULATED THE DATA AND
THE BLUE BAR REPRESENTS THE
VALUES AT 31 AND YOU CAN SEE
HERE OUR FELLOWSHIP ARE DOING
VERY WELL.
THEY WERE HIGHER THAN THE NIH AS
A WHOLE.
WHEREAS AT 31 AND AT 32 ARE AT
PAR WITH NIH AS A WHOLE.
IT'S GOING TO BE IMPORTANT TO
SEE HOW MANY OF THESE WILL GO
INTO OPHTHALMOLOGY.
WE'RE PUTTING OUR MONEY IN THE
TRAINING OF THE Ph.D.s SO WOULD
LIKE TO SEE THEM GO INTO
OPHTHALMOLOGY.
WE STARTED TO PARTICIPATE IN THE
PROGRAM IN 2015 AND BEYOND.
THE SUCCESS OF A PROGRAM IS HOW
MANY R01s YOU GET AND WE LOOKED
AT THE POSTDOCTORAL FELLOWSHIP.
THE TOTAL NUMBER OF F32 AWARDED
BETWEEN THE FISCAL YEAR 2012 AND
2022, 168.
OF WHICH 30 APPLIED FOR RO1
EQUIVALENT AND 12 WERE
SUCCESSFUL WITH A 40% SUCCESS
RATE AND THE AVERAGE NUMBER OF
YEARS WAS ONE YEAR.
AND THEY WERE ABLE TO GET IT OR
APPLIED IN TWO OVERLAPS AND WERE
ABLE TO GET THE R01 IN THAT.
IN THIS CALCULATION THE
POST-DOCTORAL FELLOWSHIPS ARE TO
APPLY K99 AND R OO THE
TRANSITION AWARD PROGRAM IN
WHICH THEY GET TWO YEARS OF
MENTORED FELLOWSHIP AND MENTORED
RESEARCH, K99 AND THEN IN THOSE
TWO YEARS THEY FIND THEIR JOB
AND LOOK FOR INDEPENDENT
POSITION AND MOVE THE MONEY TO A
DIFFERENT PLACE.
NOTE INCLUDED IS THE K99 AWARDEE
THEY'RE ABLE TO.
16 WERE ALSO SUCCESSFUL TO GET
K99s.
THIS SUCCESS RATE WILL BE HIGHER
THAN 40%.
AND ALSO I WOULD LIKE TO MAKE
ONE MORE COMMENT AT THIS POINT
HERE BECAUSE MANY OF THEM ARE
STILL FRESH WITH THEIR
FELLOWSHIP BECAUSE 2022 WE JUST
AWARDED THEM LAST PHYSICAL YEAR
AND 2021 AND 2020 AND 2019 STILL
MIGHT BE FINISHING THEIR
FELLOWSHIPS AND GETTING INTO THE
JOBS.
THEY'RE NOT EVEN APPLYING.
SO THE NUMBERS WE DID THE
CALCULATION FROM 2012 TO 2016
AND 2017 THE NUMBERS WILL BE
BETTER THAN WHAT THEY'RE SHOWING
YOU RIGHT NOW.
CHANGING GEARS HERE'S THE DATA
FOR THE INSTITUTIONAL TRAINING
GROUNDS AND THEY'RE SUCCESS RATE
AND I'VE DONE THIS FOR THE LAST
FISCAL YEAR, 2022.
LAST FISCAL YEAR WE RECEIVED TWO
K12 APPLICATIONS.
ONE WAS TYPE II AND ONE WAS A
NEW APPLICATION.
WE FUNDED BOTH OF THEM.
THE SUCCESS RATE FOR LAST YEAR
K12 WAS 100%.
FOR INSTITUTIONAL TRAINING
GROUNDS FOR PRE AND POST DOCS
WAS 63% AND WE RECEIVED 11
APPLICATIONS NEW AND REPEAT AND
OUT OF THAT WE FUNDED 7.
OUR SUCCESS RATE WAS 63%.
WHEREAS T35 THE SHORT TERM
SUMMER TRAINING INSTITUTIONAL
GRANT WE RECEIVED FOUR
APPLICATIONS AND WE FUNDED ALL
FOUR OF THEM TO THE SUCCESS RATE
WAS 100%.
THE CURRENT YEAR, FISCAL YEAR
2022 I HAVE TWO WE FUNDED IN
2022 AND THE TOTAL NUMBER OF
SLOTS IS 18 IN THOSE SO EIGHT
HAVE TWO SLOTS EACH AND TWO OF
THEM HAVE ONE SLOT EACH.
WHEREAS TOTAL NUMBER OF T32 IN
MY PORTFOLIO IS 30 AND THE
NUMBER OF POST DOCS IN 19 AND I
HAVE 11, T35'S AND THE NUMBER OF
SLOTS IS 91 SLOTS.
FROM TRAINING GROUNDS AND
FELLOWSHIP TO THE DEVELOPMENTAL
MENTOR AWARD THIS SHOWS THE K
AWARD FOR K PORTFOLIO AND
COMPARE THEM TO RESEARCH GRANTS
PORTFOLIO AS I DID FOR
FELLOWSHIPS IF YOU REMEMBER.
AND WE HAVE RETINA, CORNEA,
LENS, GLAUCOMA, SAVP WHICH IS
VISUAL PROCESSING AND LOW
VISION.
THERE'S ALMOST IDENTICAL EXCEPT
FOR THE GLAUCOMA PROGRAM FOR
CAREER DEVELOPMENT AWARDS.
IT'S TWICE AS BIG AS THAT OF THE
RESEARCH GRANTS PORTFOLIO.
AND THIS IS RIGHTLY SO BECAUSE
THIS IS COMING STRAIGHT FROM THE
CLINICIANS TO SUBMIT MORE
APPLICATION IN GAU COMA FIELD.
-- GLAUCOMA FIELD.
THIS IS THE COMPARISON AND THE K
AWARD SUCCESS RATE AGAIN THE
SUCCESS RATE IS THE NUMBER OF
APPLICATION AWARDED VERSUS
NUMBER OF APPLICATIONS
SUBMITTED.
THE BLUE BAR IS K08 AND ORANGE
IS K23 AND THE GREEN IS K99 FOR
THE FISCAL YEARS OF 2017 TO
2022.
YOU CAN SEE OUR SUCCESS RATE OF
K AWARDEES IS QUITE GOOD AND
COMPARED TO NIH AND WE ARE DOING
WELL IN THAT ARENA ALSO.
AGAIN TO ASSESS HOW SUCCESSFUL
IS THE K DEVELOPMENT AWARD?
I DID THE R01 SUCCESS RATE FOR
THIS CAREER DEVELOPMENT
AWARDEES, K23 AND K99 FOR THE
FISCAL YEAR 2012 AND 2022.
YOU CAN SEE HERE THE NUMBER OF
K08 AWARDED FOR THE SIX, SEVEN,
EIGHT YEARS OF THE PHYSICAL YEAR
PERIOD, 91, OUT OF THOSE 91, 51
SUBMITTED OR APPLIED FOR R01
EQUIVALENT AND 61 WERE
SUCCESSFUL TO GET IT AND SO HE
THE SUCCESS RATE IS 49%.
AND THE AVERAGE NUMBER OF YEARS
TO GET THE FIRST R01 WAS 1.3
YEARS.
A LITTLE BIT MORE THAN WHAT I
PRESENTED TO THE F23 POST
POST-DOCTORAL FELLOWSHIPS.
WE AWARDED 59D DURING THIS TIME
PERIOD OF 2023 TO 2022 OF WHICH
39 HARD ALREADY APPLIED FOR R01
EQUIVALENT OR 16 HAVE BEEN
ALREADY SUCCESSFUL.
THE SUCCESS RATE IS ALMOST 55%.
AND THE TIME TO TAKE THE FIRST
R01 WAS ONE YEAR.
IN THIS CALCULATION I'D LIKE
MENTION MANY OF THESE CLINICIAN
SCIENTISTS GO TO CLINICAL TRIAL
AND SUBMIT U01 GRANT AND NOT
INCLUDED THAT CALCULATION IS SO
IF YOU INCLUDE THOSE GRANTS ALSO
THE SUCCESS RATE OF THE K23
AWARDEES WILL BE EVEN BETTER
THAN 55%.
COMING LASTLY TO K99 A CAREER
TRANSITION AWARD FOR
POST-DOCTORAL FELLOW I DON'T
HAVE ANY AND WE AWARDED 115 OF
THOSE K99 AWARDEES FOR THE
FISCAL YEAR 2012, 2022 OF WHICH
39 HAVE ALREADY APPLIED FOR R01
EQUIVALENT OF WHICH 23 WERE
SUCCESSFUL AND THE SUCCESS RATE
IS 59% AND THE AVERAGE NUMBER OF
YEARS TO GET THE FIRST R01 IS
1.3 YEARS.
CHANGING GEARS I'D LIKE TO TALK
ABOUT THE TRAINING INITIATIVES.
THERE'S A BUNCH OF OTHER
TRAINING INITIATIVES WHICH ARE
INSTITUTED BY OTHER INSTITUTES.
NIGMS COMES UP WITH A MOSAIC
K99/R00 TO PROMOTE DIVERSITY FOR
THESE RESEARCH AREAS AND MOSAIC
STARS FOR MAXIMIZING
OPPORTUNITIES FOR SCIENTIFIC AND
ACADEMIC INDEPENDENT CAREERS.
AND BRAIN INITIATIVE DIVERSITY
R00.
THERE'S DIFFERENCES AND IN CASE
ANYBODY'S INTERESTED I'D BE
HAPPY TO TALK ABOUT IT.
WE HAVE THE NIH BLUEPRINT
DIVERSITY SPECIALIZED IN
PREDOCTORAL TO POSTDOCTORAL
ADVANCEMENT IN NEUROSCIENCE AND
THE AWARD IS F99 AND K00.
THIS IS ANALOGOUS TO K99 AND R00
BECAUSE IN THIS CASE YOU START
YOUR F99 IN YOUR SENIOR LAST TWO
YEARS OF GRADUATE STUDIES AND
AFTER FINISHING THOSE TWO YEARS
IN YOUR MENTORS LAB AND GETTING
YOUR Ph.D. YOU MOVE ON TO A
POSTDOCTORAL FELLOWSHIP LAB IN
YOUR K00 AND SPEND THREE YEAR IN
THAT LAB.
AND THEY'RE ELIGIBLE TO APPLY
FOR K99 AND R00 AND THEN GET THE
K99, R00 AND ESTABLISH THEIR
INDEPENDENT LAB WITH R00.
THIRDLY, I'D LIKE TO TALK ABOUT
AN INSTITUTIONAL TRAINING
PROGRAM WHICH IS INSTITUTED BY
TRANS-NIH PRINT CALLED JOINTLY
SPONSORED INSTITUTIONAL
PREDOCTORAL TRAINING PROGRAM.
IT'S FOR PREDOC INSTITUTIONAL
TRAINING PROGRAM AND A NUMBER
ARE FUNDED BY THAT.
COMING TO LOAN REPAYMENT PROGRAM
CATHY MENTIONED WE ARE MANDATED
BY CONGRESS TO PRESENT TO YOU
THE STATE OF LOAN REPAYMENT
PROGRAM FOR THE LAST FISCAL YEAR
WE JUST FINISHED.
WHAT IS LOAN REPAYMENT PROGRAM?
THE PURPOSE IS TO ATTRACT HEALTH
PROFESSIONALS TO A CAREER IN
RESEARCH AND PAY THEIR
EDUCATIONAL DEBT OR THE DEBT
THEY INCURRED DURING MEDICAL
SCHOOL AND EVEN UNDERGRADUATE.
SO WHAT IT DOES IT WILL PAY
$50,000 OF THEIR DEBT PER YEAR
AND ALSO THE IRS TAXES WHICH
WILL BE COMING OUT OF THIS
$50,000 WHICH WILL BE ADDED TO
YOUR INCOME SO IT COMES AROUND
$65,000 TO $70,000 NIH PAYS.
YOU HAVE TO BE A U.S. CITIZEN OR
U.S. PERMANENT RESIDENT AS WAS
THE CASE FOR NISA FELLOWSHIP IN
CAREER DEVELOPMENT AWARDEES.
AND ONE HAS TO COMMIT 50% TIME
TOWARDS RESEARCH SO YOU KEEP
APPLYINGFUL YOUR DE-- APPLYING
UNTIL YOU GET IT AND YOU DON'T
HAVE TO HAVE AN R01 OR R21 OR
ANY OTHER KINDS.
YOU CAN JUST SUPPLY THE
REQUIREMENTS.
ONLINE APPLICATION IS EASY.
IT'S NOT A BIG APPLICATION.
IT'S PEER REVIEWED AND THE
DEADLINE IS NOVEMBER 15.
THE DEADLINE IS COMING SO I
REQUEST MY COUNCIL MEMBERS TO GO
BACK AND PROMOTE IT AND
ESPECIALLY I GOT AN E-MAIL
YESTERDAY BECAUSE OF THE NEW LAW
PASSED BY PRESIDENT BIDEN AND
THE EDUCATIONAL DEBT WILL BE
TAKEN CARE OF AND THE NUMBER OF
APPLICATION HAS GONE DOWN BY
THIS TIME OF THE YEAR SO NEI
PARTICIPATE IN THE LOAN PROGRAM
AND CLINICAL RESEARCH AND HAZARD
DISPARITY RESEARCH, PEDIATRIC
AND CLINICAL 30 HEALTH D
DISPARITIES AND WE STARTED IN
RESEARCH IN EMERGING AREAS TO
HUMAN HEALTH THAT IS REACH.
TO SHOW YOU THE PAST FISCAL
YEAR'S DATA WE RECEIVED NEW SIX
APPLICATION FOR THE FIRST-TIME
APPLICANTS AND 70 WERE REPEAT.
YOU CAN APPLY MULTIPLE TIMES AND
THEY KEEP COMING BACK AND
REAPPLYING AND WE FUNDED 20.
SO THE FUNDING DATE WAS PRETTY
GOOD, 87%.
AS YOU COMPARE THIS TO NIH THIS
IS 59% AND WE FUNDED 1,268, 59%
AND THE DOLLAR BUDGET ALLOCATED
TO US TO TAKE CARE OF THIS LRP
FOR FISCAL YEAR 2022 WAS $1.3
MILLION.
WHAT ARE THESE PEOPLE AND WHAT
KIND OF DEGREE DO THEY HAVE,
M.D. OR Ph.D. AND I THINK THE
ANALYSIS FOR THE FISCAL YEAR
2017 TO 2021 AND THE TOTAL
NUMBER OF LRP FUNDED
APPLICATIONS WAS 140.
AND OUT OF WHICH 41% WERE M.D.,
PH.D.
31% WERE OD, Ph.D. AND Ph.D.s
ALONE WERE 28%.
AND IF YOU SEE OTHER
DEMOGRAPHICS OF THE FUNDING
HISTORY OF THESE CANDIDATES WHO
ARE LYING AND GETTING SUCCESS,
72% OF THEM HAD INDIVIDUAL Ks OR
R01 OR R21 FUNDING.
30% OF THE OD/Ph.D.s HAD Ks AND
Rs AND Ph.D.s WERE 62% HAD
HISTORY OF FELLOWSHIP FUNDING,
K99 FUNDING AND R01, ETCETERA
FUNDING.
AGAIN, GOING FURTHER A LITTLE
BIT, FOR THE PHYSICAL YEAR 2012
TO 2022 LRP ANALYSIS THE NUMBER
OF APPLICATIONS SUBMITTED DURING
THESE PHYSICAL YEARS, AND THE
SUCCESS RATE WAS 74%.
AND THE TOTAL NUMBER OF PEOPLE
APPLYING WAS 42%.
AND THE AVERAGE NUMBER 1.6
YEARS.
INCLUSION OUR TRAINING PROGRAM
IS QUITE SUCCESSFUL AND DOING
WELL.
I ALSO WISH TO THANK FOR ALL WHO
HELPED WITH THE DATA ANALYSIS
AND I'LL STOP HERE AND THANK YOU
FOR YOUR ATTENTION.
I'D BE HAPPY TO ANSWER ANY
QUESTIONS YOU HAVE.
>>THANK YOU.
I SEE JAMES' HAND UP.
>>THANK YOU FOR THAT
PRESENTATION.
THAT WAS INFORMATIVE.
I'M WONDERING, IF THERE ARE ANY
IDEAS ABOUT TWEAKING EXISTING
MECHANISMS.
IF YOU'RE A YOUNG INVESTIGATOR
YOU HAVE THE NEW INVESTIGATOR
STATUS WHEN YOU APPLY FOR THE
R01.
IN SOME CASES I FEEL LIKE YOUNG
INVESTIGATORS ARE ATTEMPTED TO
APPLY FOR AN R31 BECAUSE THERE'S
NO PRIOR REQUIREMENT BUT THE
STATISTICS SHOW R21s ARE MORE
COMPETITIVE AND HARDER TO GET
THAN R01s.
I'M WONDERING IF YOU HAVE A
COMMENT.
>>WHENEVER ANY OF MY YOUNG
INVESTIGATORS CALL ME AND HAVE
THE NOTION THAT R21 DOESN'T
REQUIRE ANY DATA, THEN FOR TWO
YEARS THE BUDGET IS LOW SO IT
SHOULD BE EASIER TO GET, THAT'S
NOT THE CASE AND THE DATA SHOWS
FOR THE LPG PROGRAM THE SUCCESS
RATE AT NEI IS 14% TO 15%
COMPARED TO 22% TO 25% FOR R01s.
I ALWAYS SHOW A SLIDE TO SHOW
THE R01 YOU HAVE THE ADVANTAGE
OF EARLY STAGE INVESTIGATOR
STATUS IN TERMS OF YOUR R01
COMMISSION.
YOU ARE REVIEWED AND NEED ONE OR
TWO DATA TO BASE YOUR HYPOTHESIS
ON ONE OR TWO PIECES OF DATA.
IT'S EASIER FOR THEM TO GO FOR
AN R01.
YOU'RE RIGHT.
I KEEP TELLING THEM BUT THE
MAJORITY ARE HERE BUT SOME OF
THEM STILL -- LIKE SOME ARE
BETTER AND I'M NOT SAYING IT'S
IMPOSSIBLE TO GET R21 BUT IT'S
NOT A GOOD IDEA FOR THEIR TIME.
ALMOST SPEND THE SAME TIME
WRITING AN R21 AND YOU'RE
WRITING SIX PAGES AND THE FORMS
AND EVERYTHING ELSE IS THE SAME
AND EVERYTHING.
THERE'S MORE WORK TO YOU GET THE
MONEY FOR FIVE YEARS AND IF FOR
TWO YEARS, THE CLOCK IS TICKING
BY THE TIME THEY GET THE PROFS
OF PROCESS AND THE R01 IS
REVIEWED MORE STRINGENTLY.
>>THANK YOU VERY MUCH.
>>THERE'S ANOTHER R01 MECHANISM
CALLED THE KATZ AWARD WHICH ESIs
ARE ELIGIBLE TO APPLY FOR AND
PROHIBITS DATA IN THE
APPLICATION.
THAT MIGHT BE ANOTHER OPTION FOR
SOMEONE WHO DOESN'T HAVE
PRELIMINARY DATA.
JUST WANTED TO MENTION THAT AND
NEI HAS ONE OF THE HIGHEST
SUCCESS RATES FOR THOSE
APPLICATION S.
>>THANK YOU FOR BRINGING THAT
UP.
>>YOU CAN HAVE PRELIMINARY DATA
BUT IT HAS TO BE PUBLISHED OR
BASED ON SOMEBODY ELSE'S DATA.
THE PROBLEM IS IS THAT YOU HAVE
TO JUSTIFY THE NEW AREA OF YOUR
RESEARCH.
I KIND OF TELL THEM YOU CAN GO
AHEAD AND APPLY FOR KATZ BUT YOU
HAVE TO MAKE SURE THAT YOU HAVE
ALL THE REQUIREMENTS.
YOUR HAND'S UP KATIA?
>>I'M SURPRISED HOW LONG IT
TOOK THE 1.3 YEARS.
WHAT'S THE AVERAGE NUMBER OF
YEARS TO GET THE R01.
>>THERE ARE A FEW OUTLIERS IN
THE CALCULATION.
SOME TOOK SIX YEARS, SEVEN
YEARS.
I TENDED TO PUT THEM OUT THE
MAJORITY WERE ABLE TO GET ONE
YEAR AND THE AVERAGE CAME TO ONE
YEAR I TOOK OFF THE OUTLIER.
ONE TOOK 13 YEARS ON THAT.
THE MAJORITY ARE WITHIN ONE AND
A HALF AND TWO YEARS.
THE AVERAGE CAME TO BE ONE YEAR.
>>THANK YOU FOR THE INFORMATIVE
PRESENTATION.
I WANT TO THANK YOU SPECIFICALLY
BECAUSE IT WAS THROUGH THIS
PRESENTATION A COUPLE YEARS AGO
THEY LEARNED ABOUT THE PROGRAM.
MY GRADUATE STUDENT APPLIED AND
SUCCESSFULLY GOT ONE.
I WAS CONCERN ED BECAUSE I HAD
THE PRIVILEGE TO KNOW THE
INFORMATION THROUGH YOU.
HOW ARE WE ADVERTISING THIS OR
REACHING THE RIGHT CANDIDATES
FOR THESE MECHANISMS?
THEY'RE ALL BROUGHT AND SITTING
IN FRONT OF THE COMPUTER.
AND EVERYTHING IS THERE NOW.
DR. CHIANG GIVES THE INFORMATION
AND ENCOURAGE THEM TO CALL AND
TALK TO ME AND IT'S THERE.
>>I WANTED TO KNOW IF THERE
WERE OTHER MECHANISMS.
ANY STUDENT WAS NOT AWARE AND --
MY STUDENT WAS NOT AWARE AND I
SAID IT'S A FANTASTIC
OPPORTUNITY.
>>I'M HAPPY WE FUNDED YOURS.
I REMEMBER THAT.
>>KATIA, A WORD OF THANKS FOR
RAISING THAT.
IF YOU KNOW, YOU KNOW, IF YOU
DON'T KNOW, YOU DON'T KNOW.
IT SOUNDS LIKE THE
IMPLEMENTATION DISCUSSION WE HAD
EARLIER TODAY IF YOU'RE ONE OF
THOSE PEOPLE WHO DOESN'T HAVE
THE MECHANISM TO FIND OUT WE TRY
TO PROMOTE THIS AN WE'VE BEEN
USING SOCIAL MEDIA AS A
MECHANISM TO PUSH THESE THINGS
OUT.
IF YOU HAVE OTHER IDEAS HOW TO
GET THE WORD OUT HELP US WITH
THOSE IDEAS.
>>WE CAN SAY LOOK WHAT I GOT
AND THERE'S AN OPPORTUNITY TO
APPLY.
WE SHOULD BE RECRUITING THE
AWARDEES TO TRY TO PASS THE
BATON AND GIVE INFORMATION TO
OTHERS THAT MAY NOT BE AWARE.
THAT'S ONE OF MY IDEAS.
>>THANKS, KATIA.
>>WE ARE THINKING OF HAVING A K
SYMPOSIUM.
THAT'S ONE WAY TO PROMOTE THE
CAREER DEVELOPMENT AWARDEES.
I WANT MORE APPLICATIONS.
I HOPE IT GOES TO 2% TO 3%.
ING
>>SOCIAL MEDIA AND SOCIAL
MEDIA.
THAT'S WHAT THESE KIDS ALWAYS
LOOK AT.
MAYBE TWITTER, INSTAGRAM.
>>WHEN THEY BROWSE THEY SHOULD
LOOK AT NIH.
THAT WOULD BE HELPFUL.
>>I FEEL A LITTLE RIDICULOUS
TROLLING FOR FOLLOWERS ON SOCIAL
MEDIA BEHAVING WORSE THAN MY
KIDS.
BUT THIS IS PRECISELY THE REASON
WE DO IT.
UNLESS PEOPLE ARE LISTENING TO
WHAT WE PUT OUT AND WE HAVE DONE
AN AMAZING JOB PUTTING IT
TOGETHER BUT WE NEED PEOPLE TO
READ IT AND WHATEVER WE CAN DO
TO GETS THE WORD OUT IN THE
COMMUNITY WOULD BE AWESOME.
>>IF WE ASK THE YOUNG PEOPLE IN
OUR LABS HOW MANY TIMES PROBABLY
NONE AND IF WE PROMOTE AND TELL
THEM, I THINK THAT'S THE KEY IS
SOCIAL MEDIA.
>>THANK YOU FOR LISTENING.
>>AND THANK YOU FOR THE
FEEDBACK IN MAKING SURE WE'RE
COMMUNICATING ALL THE
OPPORTUNITIES AVAILABLE FOR
TRAINING AND OTHER THINGS.
I WANT TO -- WE'RE GETTING CLOSE
TO THE END OF THIS OPEN SESSION
BUT WE HAVE TIME SO I WANTED TO
GIVE PEOPLE A CHANCE TO ASK
QUESTI
QUESTIONS MORE PROBABLY IF YOU
HAVE QUESTIONS FOR DR. CHIANG OR
WANTED TO RAISE ISSUES.
I KNOW PEOPLE ARE PROBABLY
HUNGRY BUT WANTED WE GAVE A FEW
MINUTES TO ENTERTAIN GENERAL
QUESTIONS.
>>I THINK THIS IS A GOOD TIME
TO BRING THE DATA MANAGEMENT
PLAN.
MY UNIVERSITY GOT INTO A
WORKSHOP TO LOOK AT THE
QUESTIONS THAT WERE STANDING AND
A HUGE ONE IF THE DATA HAS TO BE
PUT OUT BEFORE THE PUBLICATION
AND WORRIED ABOUT IT BE SCOOPED
THE QUESTION COMES IS IT OKAY
YOU PUT IT IN A REPOSITORY AND
THEN HAVE AN EMBARGO UNTIL THAT
GETS PUBLISHED OR IS THAT NOT
BEING CONSIDERED?
WHEN WE HAVE A THESIS OR
DISSERTATION YOU CAN PUT IN
EMBARGO FOR SEVERAL YEARS EVEN I
THINK THAT'S A COMMON QUESTION
WHEN TO RELEASE THE DATA.
AS YOU KNOW, THE WHITE HOUSE AN
NIH GUIDANCE, WE'LL HAVE TO MAKE
SURE THOSE MESSAGES ARE IN LINE.
THE BEST THING I CAN DO -- LET
ME FOLLOW-UP TO THIS.
IN FOLLOW-UP TO THE LAST MESSAGE
MIKE LAUER POINTED US TO
RESOURCE DISCUSSED ISSUES LIKE
THIS.
I'LL CIRCULATE THAT WITHIN THE
COUNCIL THE MOST UP TO DATE
GUIDANCE.
WE'LL ALSO POST IT ON SOCIAL
MEDIA IF I MAY INTERJECT MY VIEW
ON THIS, I THINK WE'RE AT A
CROSSROADS WHERE SCIENTIFICALLY
THE CULTURE IS THE OUTPUT OF THE
RESEARCH PROJECT IS THE PAPER.
WHAT I CALL 21st CENTURY SCIENCE
I THINK TWO THINGS IS IN
PARALLEL, ONE IS THE PAPER AND
THE DATA WE USED IT CREATE THE
PAPER.
TRADITIONALLY THE DATA IS
SUBSERVIENT TO THE PAPER AND TO
THE EXTENT WE CAN VIEW THE DATA
AS IMPORTANT AS THE PAPER
ITSELF, I HOPE SOME QUESTIONS
WILL TEND TO SOLVE THEMSELVES
AND THAT'S WHERE I SEE THE FIELD
HEADING.
WE'RE NOT THERE CULTURALLY TO
INCENTIVIZE.
>>IT'S A CAREER RISK PEOPLE ARE
TAKING.
>>I TOTALLY UNDERSTAND.
UP SPEAKING WITH UNIVERSITY
LEADERSHIP AROUND THE COUNTRY IS
THAT WE CAN DO THINGS AT NIH AND
ULTIMATELY WE WORK FOR
INSTITUTIONS WITH PROMOTION AN
TENURE.
AT SOME POINT WE'LL HAVE TO DEAL
WITH THIS IF WE'RE GOING TO
TRULY VALUE THESE THINGS WE'RE
WALKING ABOUT LIKE DATA SHARING,
TEAM SCIENCE, I THINK AT SOME
POINT THE COMMUNITY HAS TO COME
UP WITH WAYS TO VALUE THIS
UNEQUAL GROUNDS WITH THE PAPERS
THEMSELVES.
WE CAN TALK ABOUT THAT AT
LENGTH.
>>THANK YOU.
I HAVE OTHER QUESTIONS BUT IN
THE INTEREST OF TIME I'LL LET
THE OTHERS GO AND IF THERE'S
TIME I'LL ASK MY QUESTIONS.
>>THANKS, KATIA.
>>I HAD ANOTHER QUESTION ABOUT
THE DATA MANAGEMENT.
I'VE GONE TO SOME WEBINARS NIH
PUT ON AND THE MESSAGE I
RECEIVED WAS DIFFERENT THAN WHAT
OUR MEETINGS AND NOT ALL NEEDED
TO BE UPLOADED.
I KEEP THINKING OF THINGS LIKE
CELL CULTURE RESEARCH AND YOU
HAVE A NUMBER OF DATA POINTS BUT
YOU GET DIFFERENT OUTCOMES.
MY QUESTION IS AROUND THAT AND
SOME GUIDANCE IS IT REASONABLE
TO SAY OUR PLAN IS TO PROVIDE
DATA WHEN REQUESTED?
WITH THE CAVEAT, THESE ARE THE
SPECIFIC SITUATIONS WE USED AND
WE WOULD BE CONCERNED IF THE
CONDITIONS WERE DIFFERENT THAN
WHAT THE AND MAYBE THEY'RE
TRYING TO PUT DATA TOGETHER.
I DON'T KNOW.
DOES THAT MAKE SENSE?
>>IT MAKES SENSE.
THIS IS SOMETHING THAT WILL BE
COVERED IN DEPTH IN SOME OF THE
THINGS I'LL CIRCULATE AROUND.
IF I CAN ENCAPSULATE THE DATA
NEEDS TO BE SHARED, YOU'RE
RIGHT, NOT ALL DATA NEED TO BE
SHARED ACCORDING TO THE OFFICIAL
NIH POLICY AND ONE THING WE'RE
TRYING TO GET AWAY FROM IS THE
STATEMENT THAT DATA WILL BE
SHARED UPON REQUEST OR SOMETHING
WE USED TO ALL PUT IN THERE.
ONE SHORT ANSWER WILL BE TO
SPEAK TO YOUR PROGRAM OFFICER
ABOUT THAT AND ANOTHER WILL BE
TO CIRCULATE WHAT WILL BE
DISCUSSED AND I UNDERSTAND
THERE'S QUESTIONS IN THE
COMMUNITY ABOUT THIS.
AT THE END OF THE DAY THERE'S
CARROTS AND THERE'S STICKS.
THESE ARE STICKS IN A WAY.
I FEEL LIKE OUR COMMUNITY WILL
BENEFIT IF WE HAVE MORE CARROTS
TO ACHIEVE THIS CULTURE CHANGE
WE'RE TALKING ABOUT AND SOME
PEOPLE GET THAT AND IT'S A BIG
CULTURAL CHANGE WE'RE TALKING
ABOUT AND THANK YOU FOR ASKING.
>>I HAVE A QUESTION AND COMMENT
AROUND THE DATA SHARING.
>>I'M LEARNING ABOUT A DATA
SHARING LICENSE AND IF ANYONE
USES THE DATA THEY HAVE TO
ATTRIBUTE TO YOU AND IF SOMEONE
READS MY PAPER THEY SHOULD CITE
ME.
AND THE DIFFERENCE WITH DATA
SHARING MANDATE IS IT'S A LEGAL
MANDATE AND YOU CAN HAVE OTHER
REQUIREMENTS THAT ARE MORE
STRICT.
IT'S CHANGED THE WAY I THINK
ABOUT DATA SHARING BUT IT SEEMS
LIKE AN OPPORTUNITY.
IT'S ONE THING TO POST DATA AND
TO HAVE PEOPLECYTE -- PEOPLE
CITE ME IT'S SOMETHING I WANT TO
LEARN MORE ABOUT IT'S A COMMENT
AND QUESTION AND THE SECOND PART
IS HOW RESTRICTIVE -- IF WE'RE
GETTING NIH FUNDING TO PRODUCE
THE DATA, HOW RESTRICTIVE OF A
LICENSE CAN WE CHOOSE?
FOR INSTANCE, THERE ARE SOME
LICENSES THAT PREVENT ANYONE
FROM COMMERCIALIZING THE DATA IN
ANY FORM.
THAT'S WHAT I'M THINKING ABOUT
NOW.
THANKS.
>>JAMES, THANK YOU FOR ASKING
ABOUT THAT.
I REMEMBER WE HAD AN E-MAIL
EXCHANGE ABOUT THIS WITH THE
GROUP AND THERE WERE QUESTIONS
ABOUT THE CREATIVE LICENSE AND
AT THE TIME I LOOKED AND I'M
STILL NOT AWARE WE HAVE GUIDANCE
ABOUT CODE.
I WILL FOLLOW-UP ON THAT AGAIN.
WHEN I LOOKED AT THE TIME I
COULD NOT FIND ANYTHING ABOUT
THAT.
>>THANKS.
IT SEEMS LIKE IT COULD BE A REAL
OPPORTUNITY FOR RESEARCHERS.
THANK YOU VERY MUCH.
>>THE ONE THING I DO WANT TO
PLUG, WHICH WE PLUGGED BEFORE IS
THAT ABOUT A YEAR AGO IN THE
SPIRIT OF CARROTS IN ADDITION TO
STICKS, WE WORKED WITH EDITOR
AND CHIEF OF TVST.
THE IDEA WAS CREATING A
PUBLICATION TYPE THAT
REPRESENTED DATA SETS OR
SOFTWARE LIBRARIES.
SO THE IDEA WAS TO THE POINT
THAT PEOPLE COULD PUBLIC CODE OR
DATA SETS AND GET ACADEMIC
CREDIT FOR IT.
SINCE THAT TIME, EMILY CHU HAS
DEVELOPED THAT WITH AN
OPHTHALMOLOGY SCIENCE AN THESE
CONVERSATIONS ORIGINATED IN
DISCUSSIONS I HAD WITH THE
EDITORS AND CHIEF OF THE MAJOR
VISION JOURNAL AND MY HOPE WAS
LOOK AT THE BENEFITS OF DATA
SHARING.
WE'RE WORKING ON THAT AND IT'S
GOING TO TAKE AWHILE.
I'M NOT AWARE OF ANOTHER FIELD
THAT HAS DONE THIS IN THE SAME
WAY.
JAMES, THANK YOU FOR ASKING
ABOUT THAT AND AGAIN MORE COMING
UP.
>>AN ISSUE THAT COMES TO ME
SOMETIMES IS SOMETIMES DATA IS
NOT THE END DATA.
HAVE INTERIM DATA THAT LEADS TO
OTHER DATA.
AT WHICH POINT DO YOU SHARE THE
DATA?
ARE YOU GOING TO WAIT ANOTHER
TWO OR THREE YEARS TO HAVE THE
RESULTS?
OUR EXPERIMENTS USUALLY
CONTINUES.
THE DATA IS ALSO CONTINUOUS.
DO WE STOP IN THE MIDDLE TO
SHARE IT OR HAVE TO WAIT UNTIL
THE END?
I ALWAYS STRUGGLE WITH THAT.
>>I THINK THIS IS AN INHERENTLY
CONFUSING ISSUE.
LET ME TRY TO FIND THE POLICY
GUIDANCE.
I'LL PUT THE LINK IN THE CHAT
BOX.
THIS IS THE OFFICIAL DEFINITION
HERE.
BASICALLY ONE OF THE ISSUES
FOCUSES ON REPRODUCIBILITY.
I THINK THIS IS THE BEST SINGLE
GUIDELINE THAT GETS TO WHAT
YOU'RE ASKING ABOUT BUT I THINK
A GOOD BENCHMARK IS GOING TO BE
WHAT WOULD IT TAKE TO REPRODUCE
YOUR FINDINGS.
>>OKAY.
>>I CAN CIRCULATE THAT WITH THE
STUFF THAT WILL FOL ZWROE.
I CAN CIRCULATE THAT WITH THE
STUFF THAT WILL FOLLOW.
I KNOW WE'RE GETTING CLOSE TO
TIME BUT ANYTHING ELSE -- KATIA.
>>I WANT TO FINISH WITH THE
CONCERNS AND WE DISCUSSED BUDGET
AND YOU CAN INCLUDE THE WITHIN
THE GRANT BUT WHEN YOU HAVE FOR
EXAMPLE MECHANISMS WHERE YOU
HAVE A CAP AMOUNT LIKE THE R15s
OR THE R21s, IS THERE A PLAN TO
HAVE AN EXTRA PLACE FOR THIS
BUDGET OR WILL IT HAVE TO BE
SQUEEZED IN WHERE IT'S SOMETIMES
ALREADY LIMITED AMOUNTS OF MONEY
FOR RESEARCH?
>>THAT'S ANOTHER GOOD QUESTION.
IT'S A QUESTION THAT WE'VE BEEN
HEARING A LOT.
I'M GOING TO ADDRESS THIS AND
CATHY, LET ME ASK IF YOU CAN
COMMENT ON THIS AS WELL.
WHAT I HEARD FROM MIKE LAUER'S
SESSION LAST TIME IS YOU SHOULD
REQUEST BUDGET TO IMPLEMENT THE
DATA SHARING AND MANAGEMENT PLAN
AND YOU DO NOT NEED TO SUBMIT A
MODULAR BUDGET.
I THINK THIS THE ROUTE OF SOME
OF THE QUESTIONS PEOPLE FELT
THERE WAS A CAP TO IT.
WHAT I HEARD BACK FORMALLY AND
INFORMALLY WAS, WELL, WE HAVE TO
STICK TO A MODULAR BUDGET AND
CATHY CAN YOU SPEAK TO THAT?
THERE'S A HARD CAP ON THAT AND
FOR THE R15.
THAT'S AA GOOD QUESTION BECAUSE
THOSE ARE HARD TO GET UNDER
BUDGET ANYWAY BUT HAVE A USEFUL
PURPOSE FOR PEOPLE.
I'M GOING IT TAKE THAT FEEDBACK
TO A GROUP I'M ON AND GET ADVICE
ON THAT AND I THINK WHAT
DR. CHANG WAS FOLLOWING UP ON IN
THE CONVERSATION LAST TIME IN
FEELING YOU HAVE TO COME IN WITH
A MODULAR BUDGET TO BE
COMPETITIVE OR TO GET PRIORITY
FOR FUNDING.
THAT SHOULDN'T BE THE CASE AND
NOT THE CASE.
REQUEST WHAT YOU NEED IF YOU'RE
COMING IN WITH AN R01 AND WHAT
YOU WOULD NEED TO SHARE THE DATA
AND THERE'S EXAMPLES OF DATA
SHARING CALCULATORS AND THE
MATERIALS WE SENT LAST TIME BUT
WILL SEND OUT AGAIN.
WE DO ENCOURAGE PEOPLE TO BE
CONSERVATIVE WITH THEIR BUDGET
BUT IF IT DOESN'T WORK FOR YOU,
THERE'S NO RULE YOU MUST COME IN
WITH THE MODULAR BUDGET.
>>THANK YOU FOR THE
CLARIFICATION.
I LOOK FORWARD TO THE
INFORMATION ON THE R15s AND
R21s.
>>MY UNIVERSITY THE LIBRARIES
HAVE A DATA REPOSITORY BUT IT'S
NOT REALLY CURATED.
IT SEEMS LIKE THERE WOULD BE A
DIRECTION ON THIS?
>>WHAT DO YOU MEAN BY CURATED
REPOSITORY?
>>SOMEONE IS HAVING OVERSIGHT.
IT SEEMS LIKE ANYTHING CAN BE
PUT UP THERE AND WILL IT BE
CONTROLLED IN SOME HOMOGENOUS
WAY SO IT'S USEFUL.
>>I THINK THERE ARE MULTIPLE
PARTS TO YOUR QUESTION.
>>I THINK IT DOES VERY LITTLE
GOOD FOR ANYBODY TO PUT
INFORMATION UP THAT'S GOING TO
BE NOT INTERPRETABLE TO ANYBODY
ELSE.
IN THAT CASE WE'RE WASTING
RESOURCE TO PUT SOMETHING UP.
I HOPE THAT WE DON'T END UP IN A
SITUATION WHERE PEOPLE ARE DOING
THAT OR PURPOSELY DOING THAT SO
THEIR DATA ISN'T USEFUL TO
ANYBODY ELSE EXCEPT FOR THEM
BECAUSE OUR COMMUNITY LOSES AND
I THINK THERE'S COMPONENTS TO
CURATION.
ONE OF THEM IS MAKING SURE YOUR
DATA ARE IN THE SAME LANGUAGE AS
ANOTHER INVESTIGATOR WHO IS
WORKING IN THE FIELD IN SOME
WAYS THAT'S SOMETHING WE CAN
HELP CONTROL THE NARRATIVE FOR
AND I TALKED ABOUT THE COMMON
DATA MODEL CARRIE GETS AND
MICHELLE ARE WORKING ON.
IN SOME CASES THAT'S SOMETHING
THE INVESTIGATORS THEMSELVES
HAVE TO WORK UPON HOW CAN WE
REPRESENT DATA THAT YOU USE IN
THE SAME WAY.
IT TRULY IS USEFUL TO THE
COMMUNITY I HOPE IT WILL
STIMULATE PEOPLE IN THE
COMMUNITY TO HAVE THOSE
CONVERSATIONS.
WE KNOW WHERE PEOPLE ARE
ESSENTIALLY WORKING ON THE SAME
PROJECT AND IF WE COLLECT THINGS
THE SAME THERE'S GOING TO BE A
LOT OF BENEFITS OF DOING THAT.
>>ARE THERE EXAMPLES OF DATA
MANAGEMENT OR REPOSITORY PEOPLE
CAN LOOK AT TO GET GUIDANCE?
>>THERE'S A LIST OF WHAT ARE
CALLED GENERALIST REPOSITORYIES
AND IS THE PLACE I'LL SUGGEST
AND SOME UNIVERSITIES HAVE
BUILDING THESE AND WE CAN
CIRCULATE A LINK TO SOME OF
THO
THOSE.
>>I DON'T SEE ANYTHING THAT
SAYS IF YOU'RE SUBMITTING DATA
THAT WAY EXCEPT FOR GENOMIC.
I SAW THE GENOMIC.
THERE'S A LIST THAT NIH ABOUT
AND THEY WORK FOR SOME TYPES OF
DATA AND MAY NOT.
WE CAN DIG UP THAT SPECIFIC LINK
AND ASKED ABOUT DATA SHARING AND
MANAGEMENT PLANS.
YES, THEY'RE TRYING TO WORK THAT
OUT AND NOW THEY HAVE A SET OF
QUESTIONS TO GUIDE YOU AND IT'S
TWO PAGES THE PLAN IS TO DEVELOP
TEMPLATES WHETHER IT'S
EPIDEMIOLOGY STUDY THOSE ARE ALL
THINGS IN THE WORKS.
>>THANKS, CATHY AND EMMY.
ANYTHING ELSE WE SHOULD TALK
ABOUT OR IS IT TIME FOR A BREAK?
>>WE CAN USE A BREAK AND WE'RE
ONLY A LITTLE BIT BEHIND AND I
DON'T THINK THE CLOSED SESSION
WILL TAKE HOWEVER LONG I'VE
SCHEDULED IT FOR.
LET'S PLAN TO BE BACK HERE AT 5
TO 3:00.
THAT'S A LITTLE BIT LONGER THAN
20 MINUTES BUT WE'LL SEE YOU
BACK AT 5 TO 3:00.
REMEMBER YOU NEED TO CLOSE THIS
OUT AND GO TO THE CLOSED SESSION
LINK.
IF ANYBODY NEEDS IT RECENT SEND
ME OR NATHAN AN E-MAIL AND A
WANT TO THANK EVERYBODY AND I
WANT TO THANK JENNY AND VICTOR
FOR PARTICIPATING.
I'LL TURN IT BACK TO MIKE IN
CASE HE HAS CLOSING THOUGHTS FOR
YOU.
>>I WOULD SAY THE SAME THING.
JENNY AND VICTOR WELCOME AND
LOOK FORWARD TO THE THINGS WE'LL
DO TOGETHER AND THE TWO WILL ADD
TO THIS GROUP.
THANK YOU FOR YOUR ENGAGEMENT.
AND CATHY TALKED ABOUT WHAT
RINAD AND JENNY SUN HAD TALKED
ABOUT TODAY AND WE TALKED ABOUT
IMPLEMENTATION SCIENCE AS TAKING
CLINICAL RESEARCH FINDINGS AND
DISSEMINATING THEM TO THE
COMMUNITY AND CAN WE STEP BACK
AND IMPLEMENT BASIC SCIENCE
FINDINGS IN THE CLINIC.
I HOPE THIS IS SOMETHING WE CAN
THINK ABOUT BROADLY.
IT MAY BENEFIT OUR ENTIRE
COMMUNITY.
WITH THAT, HAVE A GOOD BREAK AND
LOOK FORWARD TO THE CLOSED
SESSION.
CATHY, THANK YOU FOR MANAGING
ALL THIS.
>>THANKS EVERYONE.