MY INTEREST IS CLINICAL RESEARCH.
I AM FROM SAN FRANCISCO
DISABILITY RIGHTS ADVOCATE AND A
MEMBER OF THE AFFECTED COMMUNITY
OF PEOPLE OF BLIND AND THE
VISION.
GOOD MORNING I'M THE
EXECUTIVE SECRETARY FOR THE
NATIONAL ADVISORY I COUNSEL ALSO
FROM NEI AND SERVING AS THE
ACTING DIRECTOR.
I AM DELIGHTED TO SEE YOU ALL
HERE TODAY.
ON THE DIRECTOR AT JOHNS
HOPKINS AND I HAVE AN INTEREST
IN THE IMPACT OF THE INDIVIDUAL
AND HOW THAT CAN BE MODIFIED
BEHAVIORALLY.
GOOD MORNING I AM VICTOR PEREZ.
MY INTEREST.
>> OHIO STATE UNIVERSITY COLLEGE
OF OPTOMETRY AND WORKING WITH
INFANTS AND CHILDREN.
........
>> THANK YOU TO ALL OF YOU.
I REALIZE THAT THIS GAVEL IS
BEHIND MY LAPTOP.
I DID NOT SEE IT TECHNICALLY WE
ARE NOT IN SESSION UNTIL IT IS
US.
THANK YOU TO ALL OF YOU IT IS
GREAT TO HAVE YOU HERE.
LET'S DISCUSS LOGISTICS AND BEST
PRACTICES.
>> AGAIN I REALLY AM GLAD TO
HAVE YOU HERE HAVING THIS TODAY
FROM WHAT WAS ORIGINALLY
SCHEDULED.
WELCOME IN ADDITION TO
COUNCILMEMBERS I WANT TO EXTEND
A WELCOME TO THE RESEARCH AND
ADVOCACY COMMUNITY TO AN EI
STAFF AND OUR COLLEAGUES FROM
THE CENTER FOR SCIENTIFIC REVIEW
AND MEMBERS OF THE PUBLIC WHO
ARE WATCHING ON THE VIDEOCAST
TODAY.
THANKS TO COUNCILMEMBERS AND
STAFF FOR CAREFUL PREPARATIONS
AND YOUR PATIENCE AS WE NAVIGATE
TRAVEL AND OTHER LOGISTICS I
KNOW THAT CAN BE CHALLENGING.
ALSO THANK YOU TO THE DOCTORS TO
AGREEING TO EXTEND THEIR TERMS
FOR FEBRUARY MEETING WE ARE
WAITING FOR THIS LATE TO BE
APPROVED FOR THE DEPARTMENT SO
THANK YOU SO MUCH FOR THAT.
SO WE WILL NOT SAY GOODBYE TO
YOU TODAY.
WE APPRECIATE THAT.
AND THEN THANK YOU FOR
COORDINATING THE TECHNICAL
TRAVEL AND ON-SITE LOGISTICS
THEY DID AN AMAZING AMOUNT OF
WORK AND ALSO SEAN WHO MANAGES
THE CONFERENCE ROOM WITH DAVE
AND HIS STAFF THIS IS HOW IT IS
VIDEOCAST.
I AM TECHNOLOGICALLY CHALLENGED
SO JUST A COUPLE OF REMINDERS
FOR THE HYBRID MEETING.
PLEASE IDENTIFY YOURSELF AND
FULL NAME EACH TIME YOU SPEAK AS
THERE ARE PEOPLE IN THE AUDIENCE
WHO ARE VISUALLY IMPAIRED IF YOU
ARE IN ZOOM PUT YOUR FULL NAME
IN THE BOX SO WE CAN CAPTURE ALL
OF THE PARTICIPANTS.
IF YOU ARE ON ZOOM PLEASE HAVE
THE VIDEOS OFF TO MAKE SURE YOU
ARE UN-MUTED UNLESS SPEAKING IF
YOU HAVE QUESTIONS YOU NEED TO
TURN ON YOUR VIDEO AND INTRODUCE
YOURSELF DO NOT USE THE CHAT BOX
INSTEAD OF PEOPLE VIEWING CANNOT
SEE THE COMMENTS THESE ARE
PUBLIC MEETINGS OF THE NEED TO
BE AVAILABLE TO ALL PARTICIPANTS
IF YOU ARE IN THE ROOM PLEASE
REMEMBER TO USE YOUR MICROPHONE
EVERY TIME YOU SPEAK TO
INTRODUCE YOURSELF BUT LOOK AT
THE CAMERA AS OPPOSED TO THE
SCREEN.
DON'T DO IT I'M DOING.
[LAUGHTER]
THE OPEN SESSION IS BROADCAST
LIVE AND ARCHIVED IF YOU ARE
HERE IN PERSON REMEMBER TO SIGN
IN.
I AM REQUIRED FOR SPECIAL
GOVERNMENT EMPLOYEES YOU MAY NOT
ENGAGE IN ANY LOBBYING
ACTIVITIES TODAY.
DATES FOR FUTURE COUNCIL
MEETINGS ARE LISTED ON OPEN
SESSION AGENDA AND ON THE
WEBSITE.
SO I WILL STOP AND ASK IF THERE
ANY QUESTIONS?
THE MINUTES FROM THE JUNE 2023
MEETING ARE AVAILABLE WHEN
ANYBODY LIKE TO DISCUSS THOSE
MINUTES?
I KNOW YOU READ THEM
THOROUGHLY.
IF NOT A MOTION TO APPROVE?
A SECOND?
ALL THOSE IN FAVOR OF APPROVING
THE JUNE MINUTES, PLEASE RAISE
YOUR HAND..
IT IS A REAL PRIVILEGE FOR ME
TO REPRESENT ALMOST 700 PEOPLE
THAT WORK AT THE NATIONAL
INSTITUTE TO GIVE THIS DIRECTORS
REPORT.
CAN YOU HEAR ME?
ONE OF THE FIRST THINGS I ALWAYS
DO WHEN THEY GIVE THESE TALKS IS
MENTIONED WHAT WE TALK ABOUT
HERE IS JUST THE TIP OF THE
ICEBERG WITH BETHESDA AND WITH
THIS CREW WAS DOING.
WE HAVE BEEN TRYING TO USE
SOCIAL MEDIA TO JUST COMMUNICATE
WHAT WE ARE DOING.
AND WE CONTINUE TO BE ACTIVE ON
TWITTER AND THE SOCIAL MEDIA
HANDLES AND WE HAVE BEEN MORE
AND MORE ACTIVE IN GETTING US
MORE ON LINKEDIN.
BUT IF YOU'RE INTERESTED IN
WHAT'S GOING ON IN BETHES
BETHESDA, PLEASE CONSIDER
FOLLOWING THOSE.
I'M EXCITED TO TELL YOU WHAT IS
GOING ON OVER THE PAST COUNCIL
MEETING.
AND WITH THE LEADERSHIP AND
STAFF UPDATES.
WE HAVE RECRUITED A NEW CLINICAL
DIRECTOR.
RICHARD IS SUPERB.
A RESEARCHER SPECIALIST BY
BACKGROUND.
AND IT HAS NOT BEEN EASY TO GET
SOMEONE FROM THE UK INTO THE
GOVERNMENT HERE.
BUT WE HOPE BY THE END OF THE
CALENDAR YEAR HE WILL BE HERE
AND WE ARE REALLY EXCITED ABOUT
WHAT HE WILL BRING AND WILL BE A
GREAT PARTNER.
AND THE OTHER PERSON I WANT TO
ANNOUNCE IS JESSICA RYAN THE NEW
DEPUTY EXECUTIVE OFFICER HERE AT
AN EI SO I'M EXCITED ABOUT BOTH.
A COUPLE OF OTHER PEOPLE I WANT
YOU TO KNOW ABOUT ED CAME TO US
FROM PRINCETON DIRECTING
NEUROSCIENCE TRAINING PROGRAM.
TO RUN THE TRAINING PROGRAM.
IT WITH THOSE NUMBER OF
TRAINEES.
AND ANOTHER PERSON HERE ALSO IS
A NEW PROGRAM OFFICER WITH
COLLABORATIVE RESEARCH WORK AND
SHE CAME TO US AFTER WORK OVER
10 YEARS IN THE FDA.
SO WELCOME.
I WANT TO GIVE A SHOUT OUT TO A
PROGRAM OFFICER WHO RECENTLY
RETIRED MANY OF YOU HAVE KNOWN
ELLEN.
MANY OF YOU KNOW LINDA FROM
GRANTS MANAGEMENT EVERYBODY
LOVES LINDA.
AND SHE IS BACK WITH US SO WE
ARE VERY HAPPY ABOUT THAT.
ALSO ON THE EXTRAMURAL SIDE WE
HAVE THE DIVISION SCIENCE
PROGRAMS AND ACTIVITIES SO
BASICALLY PROGRAM OFFICERS AND
GREAT REVIEW AND
ADMINISTRATION.
AND WITH THE DIRECTOR OF THE
DSP.
MIKE PASSED AWAY IN A HORRIBLE
BOATING ACCIDENT.
AND SINCE THAT TIME KATHY
ANDERSON HAS DONE AN AMAZING JOB
WITH LEADERSHIP OF THE DSP
DIVISION.
WE ARE IN THE MIDST OF
RECRUITING FOR A DIRECTOR.
NOTHING TO ANNOUNCE RIGHT NOW
BUT THAT IS UNDERWAY RIGHT NOW.
SO THANK YOU FOR ALL THE WORK
YOU HAVE BEEN DOING.
IN TERMS OF AWARDS AND
RECOGNITIONS OVER THE PAST FEW
MONTHS WITHIN THE VISION
COMMUNITY.
GORDON RECEIVED THE FELLOW AWARD
THE ASSOCIATION FOR
PSYCHOLOGICAL SCIENCE AND GORDON
IS SOMEONE WHO IS VERY WELL
KNOWN AT THE UNIVERSITY OF
MINNESOTA AND HAS BEEN THE
DIRECTOR OF MINNESOTA-BASED
RESEARCH AND WAS 1 OF THE
FOUNDING CHARTER MEMBERS AND A
LOT OF AWARDS OVER A
DISTINGUISHED CAREER.
AND FROM THE LIGHTHOUSE GUILD
AND THE APPRENTICE METAL AWARD 1
OF THE MOST PRESTIGIOUS FROM THE
ACADEMY OF OPTOMETRY AND HE HAS
UNIQUE PERSPECTIVE AS A VISUAL
IMPAIRMENT AND TO MY MIND WAS 1
OF THE FORMATIVE PEOPLE TO
DEVELOP SCIENCE OF LOW-VISION SO
CONGRATULATIONS.
ON HHS, 1 OF THE PEOPLE WE HAVE
BACK HERE IS MARIANNE REDFORD
WHO RECEIVED A CAREER
ACHIEVEMENT AWARD.
CONGRATULATIONS.
WE THOUGHT SHE RETIRED BUT NOW
SHE IS BACK.
[LAUGHTER]
AND HAS DONE SOME BEAUTIFUL WORK
IN TERMS OF TEAMBUILDING AND
MULTIDISCIPLINARY.
AND HER CAREER HAS SPANNED
VISION, DENTAL, HIV, WOMEN'S
HEALTH AND FROM PERSONAL
PERSPECTIVE THE VERY FIRST
CLINICAL TRIAL WAS THE ET ROP
STUDY.
I HAVE KNOWN HER FOR A LONG
TIME.
CONGRATULATIONS MARIANNE.
SO NOW CYNTHIA IS IN THE RETINAL
CELL AND MOLECULAR BIOLOGY WITH
A 50 YEAR SERVICE AWARD.
CONGRATULATIONS.
THIS IS A BIG 1.
A FEW WEEKS AGO IT WAS ANNOUNCED
A GROUP OF PEOPLE FROM THE
VISION COMMUNITY WHERE THE
RECIPIENTS.
I WOULD SAY THIS IS A
GENERATIONAL AWARD AND THE
REASON FOR THAT THE
LASKER-DEBAKEY AWARD HAS BEEN
GIVEN 75 YEARS AND THERE ARE 5
VISION GROUPS THAT HAVE WON
THIS.
AND LITERARY GENERATIONS AGO.
1 IS FOR VITAMIN A AND ALSO FOR
CATARACT SURGERY.
AND THEN NOW DAVID WONG FROM MIT
TO DEVELOP OCT WHICH I WOULD SAY
HAS REVOLUTIONIZED THE WAY WE
TAKE CARE OF PATIENTS.
IN FACT THE OTHER LASKER-DEBAKEY
AWARD CAME FROM DEEP MIND FOR
ALL FOR FOLD.
BASICALLY THE COMPUTER ALGORITHM
THAT PREDICTS THE STRUCTURE OF
SEQUENCE.
I THOUGHT THAT WAS FASCINATING
BECAUSE THEY HAD 1 OF THEIR
ORIGINAL COLLABORATIONS WITH THE
VISION GROUP FROM THE UK.
AND THEY HAVE DONE SOME
BEAUTIFUL WORK WITH EYE CARE
PERK I THOUGHT IT WAS VERY
EXCITING HAVING A STRONG TIE TO
THE VISION COMMUNITY.
SO A REALLY BIG YEAR.
CONGRATULATIONS TO DAVID, JIM
AND ERIC.
I WANT TO GIVE A SHOUT OUT TO
SHEILA.
THIS IS THE LEADERSHIP SCHOLARS
PROGRAM NIAMS AND O R W H THEY
PUT TOGETHER A PROGRAM 1 YEAR
AGO BASICALLY FOR LEADERSHIP AND
MENTORSHIP.
SHEILA RECEIVED THIS AWARD FOR
HER WORK FOR TREATMENT OF
JUVENILE ARTHRITIS SO
CONGRATULATIONS AND THE OTHER
THING RECENTLY ANNOUNCED EARLIER
THIS WEEK WAS NATIONAL ACADEMY
OF MEDICINE.
THIS WAS A BIG 1 THERE ARE A FEW
PEOPLE FROM OUR COMMUNITY 1 WAS
JUSTIN FROM JOHNS HOPKINS BUT
HAS DONE WORK TO SPAN MORE THAN
VISION AND IT IS INVOLVING DRUG
DELIVERY TECHNOLOGIES SO HIS
OFFICIAL CITATION RED FOR
PIONEERING DISCOVERIES AND
INVENTIONS OF TECHNOLOGIES
ESPECIALLY THE OCULAR CENTRAL
NERVOUS SYSTEM AND INTERNATIONAL
LEADERSHIP AND EDUCATION AT THE
INTERFACE AND WITH DRUG DELIVERY
TECHNOLOGIES.
SO WHO IS WELL KNOWN TO THIS
COMMUNITY AND THE CITATION RED
FOR HER LEADERSHIP TO
INVESTIGATING CELL TYPES AND
CONNECTIONS IN THE MAMMALIAN
BRAIN GENERATING LARGE-SCALE
DATA SETS TO ACCELERATE
NEUROSCIENCE DISCOVERY BY
CHARACTERIZING THE MORPHOLOGY
AND PHYSIOLOGY, HER WORK HAS LED
TO TRANSFORMATIVE UNDERSTANDING
OF CELL TYPE DIVERSITY.
>> THE OTHER PERSON WANT TO
HIGHLIGHT IS ERIC.
AND HAS DONE SOME BEAUTIFUL WORK
WITH GENOMICS AND GETTING THAT
OUT FOR CLINICAL CARE AND ALSO
HAS BEEN INTERESTED IN DIVERSITY
OF GENOMICS.
BOTH IN TERMS OF SCIENCE AND
WORKFORCE.
CONGRATULATIONS.
FROM A PERSONAL STANDPOINT, WHEN
I WAS OFFERED THIS POSITION I
HAD A 15 -YEAR-OLD WHO DID NOT
LOVE THE IDEA OF MOVING
CROSS-COUNTRY BUT ERIC CALLED
AND OFFERED A ZOOM CALL WITH HIS
KIDS AND MY KIDS.
THAT WAS A TURNING POINT.
THEY SEEMED LIKE SUCH A NICE
FAMILY.
I THOUGHT THERE IS THE SCIENCE
AND THE STORIES BEHIND THAT.
WE ALWAYS APPRECIATE THAT.
SO BACK WHEN WE HAD
KINDERGARTNERS THERE ALL OF
THESE EXERCISES AND GIVE YOU A
LIST OF NAMES AND CIRCLE THE 1
THAT DOES NOT BELONG.
THAT IS ME.
IT HAS BEEN A BIG YEAR FOR THE
VISION IT -- -- COMMUNITY FOR
NATIONAL ACADEMIES.
OVER HERE I JUST WANT TO
HIGHLIGHT A FEW EXAMPLES OF
SCIENCE THAT HAVE HAPPENED THE
PAST FEW MONTHS 1 THAT HAS COME
OUT OF THE INTRAMURAL PROGRAM
AND THE LEAD INVESTIGATORS FROM
THE RETINAL NEUROPHYSIOLOGY
SECTION.
THIS WAS A NEAT PIECE OF WORK SO
THE TOPIC IS MICROGLIA THEY ARE
IMMUNE CELLS IN THE CMS THEY ARE
IN THE RETINA AND THOUGHT TO
PLAY A CRITICAL ROLE AND
OBVIOUSLY THEY HAVE BEEN
IMPLICATED IN ALZHEIMER'S WITH
THE NEURODEGENERATION AGENT SO
WITH RETINAL MICROGLIA OVER
ACTION HAS SHOWN TO BE
BENEFICIAL TO TREAT RETINAL
DISEASES.
WHAT THE GROUP DID IS
TRANSPLANTED HUMAN MICROGLIA
WILL SALES AND 2 MOUSE RETINA.
A VERY UNIQUE SET OF WORK IS
THEIR POTENTIAL FOR MICROGLIA OH
CELL REPLACEMENT?
SO THEY DEVELOPED A PROTOCOL TO
GENERATE HUMAN -INDUCED STEM
CELL DERIVED.
AND THEN DEMONSTRATED THEY COULD
FUNCTION AND TRANSPLANTED THEM
FROM ADULT MICE AND THEY WERE
DEPRIVED FROM ENDOGENOUS
MICROGLIA AND SHOW THAT THE
CELLS CAN INTEGRATE SUCCESSFULLY
INTO THE MOUSE RETINA.
THE SIGNIFICANCE IS FOLLOWING
THE INJURY THE TRANSPLANTED
HUMAN MICROGLIA COULD
DEMONSTRATE RESPONSES TYPICAL OF
ENDOGENOUS MICROGLIA SO MAYBE
THAT'S A MODEL FOR REPLACEMENT
THERAPY.
SO CONGRATULATIONS TO DO THIS
WORK AND BOB FERRIS WAS ALSO
INVOLVED IN THIS WORK.
ANOTHER PIECE OF WORK I WANT TO
HIGHLIGHT IS WORK THAT WAS DONE
IN THE BOSTON MEDICAL SYSTEM.
THE LEAD CLINICIAN SCIENTIST ON
THIS BUT THE BACKGROUND IS THAT
CORNEAL INJURIES LIKE CHEMICAL
BURNS, CONTACT LENS INJURIES, IT
IS OFTEN TOUGH TO DO OR
IMPOSSIBLE TO DO BECAUSE OF STEM
CELL DEFICIENCY.
1 APPROACH THAT HAS BEEN TRIED
IS TO TAKE STEM CELLS FROM THE
OTHER I CAN TRANSPLANT THEM OVER
INTO THE AFFECTED EYE.
BUT YOU NEED A LOT OF STEM
CELLS.
SO WHAT THIS GROUP DID IS
DEVELOPED A TECHNIQUE CALEC THEY
REMOVE THE STEM CELLS ALMOST
LIKE A BIOPSY AND EXPAND THEM
AND GROW THEM ON THE MEMBRANE
GRAFT AND HAVE DEVELOPED
TECHNIQUES TO DO THAT ON A LARGE
ENOUGH SCALE TO THEN TRANSPLANT
TO THE AFFECTED EYE.
AND WHAT THEY HAVE SHOWN IN THE
PHASE I STUDY IS CALEC WAS SAFE
AND WELL TOLERATED SO IT TURNS
OUT 2 OF THE PATIENTS WERE ABLE
TO UNDERGO SUCCESSFUL CORNEAL
TRANSPORTATIONS AND 2 OF THEM
GOT BETTER WITH THE
TRANSPLANTATION.
YOU WERE INVOLVED WITH THIS WAS
ANYTHING ELSE YOU WOULD ADD?
>> THERE IS A LOT TO ADD BUT IN
GENERAL, THERE IS A WHOLE NEW
WAVE OF DERIVING CELLS FOR CELL
-BASED THERAPY WHETHER IN
FREE-FORM OR HYDROGEL OR
SCAFFOLDS WITHIN DIFFERENT
COMPARTMENTS OF THE EYE.
IT IS A NEW TECHNOLOGY FOR
EXPANSION OF CELLS FROM THE
HEALTHIER I TO THE LESS
HEALTHIER I.
AND THE NEXT STAGE DO EXPANDING
IN VITRO FOR COMPLICATIONS SO
THIS IS VERY EXCITING THERE WAS
MORE ON THIS TECHNOLOGY THAT WE
BEGAN THIS PROJECT IN 2006 AND
THEN WITH WE COULD TAKE IT TO
THE NEXT LEVEL.
>> CONGRATULATIONS AND THERE WAS
A MANUFACTURING TEAM HERE AT THE
INSTITUTE WITH COLLABORATIVE
WORK.
GOT A FAIR AMOUNT OF PRESS THAT
EYE LOVED READING ABOUT.
SO LET ME MOVE ON.
1 OF THE THINGS WE HAVE BEEN
TRYING TO DO IS FOCUS ON OUR
MISSION.
YOU HAVE SEEN THIS A MILLION
TIMES WITH SOME ITERATIONS IN
THE PAST HEALTH US WITH THE
MISSION STATEMENT SO OUR MISSION
TO ELIMINATE VISION LOSS AND
IMPROVE QUALITY OF LIFE THROUGH
VISION RESEARCH AND THESE ARE
THE FULL -- -- THE 4 BULLET
POINTS.
DRIVE INNOVATIVE RESEARCH.
FOSTER COLLABORATION.
RECRUIT, INSPIRE, AND TRAIN
INDIVIDUALS TO EXPAND AND
STRENGTHEN THE VISION
WORKFORCE.
EDUCATE HEALTHCARE PROVIDERS AND
SCIENTISTS AND POLICYMAKERS IN
PUBLIC ABOUT ADVANCES IN VISION
RESEARCH.
IN THAT SPIRIT FOR THE REST OF
THIS TALK WILL TAKE DIFFERENT
COMPONENTS OF THE 4 BULLET
POINTS AND GIVE EXAMPLES OF WHAT
IS HAPPENING OVER THE PAST FEW
MONTHS.
1 OF THESE IS FOSTER
COLLABORATIONS.
THESE EXAMPLES ARE NEUROSCIENCE
AND REGENERATIVE MEDICINE.
BUT A COUPLE YEARS AGO WE
PUBLISHED A STRATEGIC PLAN.
A FIVE-YEAR STRATEGIC PLAN.
WE HAD GROUPS OF PEOPLE.
MANY ARE SITTING IN THE BACK
RIGHT NOW.
TRULY A LARGE GROUP TO LOOK AT
THESE TOPICS OF THE STRATEGIC
PLAN TO FIGURE OUT WHICH WOULD
RISE TO THE TOP TO TRY TO
IMPLEMENT THROUGH TARGETED
PROGRAMS.
1 OF THE THING OUR GROUP BECAME
INTERESTED IN WAS PLASTICITY.
AND MARTHA HAS BECOME THE LEAD
FOR THIS.
WITH THE RATIONALE THERE IS A
LOT OF SCIENCE THAT CAN BE DONE.
AND THE SYSTEM IS A GREAT AREA
FOR DOING THAT INNOVATIVE
SCIENCE.
SECOND THERE ARE DISEASES OVER
PLASTICITY.
TBI, LOSS OF VISION, STROKE,.
SO WITH THAT WHAT WE HAVE
STARTED WITH SO LEADING THIS
THAT IS AN OPEN VIRTUAL MEETING
JANUARY 2024 TO LOOK AT THE GAPS
OF KNOWLEDGE.
THIS IS A GREAT PROGRAM.
I WAS ACTUALLY BLOWN AWAY.
SO THERE ARE 4 TRACKS.
1 IS QUARTER GOES CELLULAR
MECHANISMS.
SECOND IS LED BY CARNEGIE MELLON
AND THEN SUB PARTICLE MECHAN
MECHANISMS.
AND THEN RETINAL REMODELING.
SO THE SPEAKER LIST IS
FABULOUS.
SOME OF THE NAMES I REMEMBER
SEEING ARE SURREAL GREAT
SPEAKERS AND SCIENTISTS.
THE QR CODE TAKES YOU TO MORE
INFORMATION ABOUT THAT
WORKSHOP.
WE ARE REALLY LOOKING FORWARD TO
WHAT THE NEXT STEPS WILL BE THAT
COME OUT OF THIS.
THE OTHER THING I WANT TO
HIGHLIGHT THE BOB CARTER IS THE
DEPUTY DIRECTOR SO THIS IS
BASICALLY A WORKING GROUP OF
REGENERATIVE MEDICINE.
AND THE BACKGROUND HERE IS THIS
PROJECT INNOVATION PROJECT
INVOLVING FUNDING PROJECTS IN
THIS AREA AND HAS HAD A COUPLE
HIGH PROFILE PROJECTS IN THIS
AREA.
AND THE OTHER PIECE OF
BACKGROUND ALL OF YOU HAVE KNOWN
ABOUT IS A PUBLIC-PRIVATE
PARTNERSHIP INVOLVING GENE
THERAPY.
AND THEN THAT WAS LED A LOT
WITHOUT.
SO GENE THERAPY HAS BEEN VERY
SUCCESSFUL WITH CLINICAL TRIALS
THAT WERE FUNDED IN 3 OF THOSE
TRIALS WERE FOR EYE DISEASES.
BUT THERE HAS BEEN SOME
DISCUSSION ABOUT PUTTING
TOGETHER THE EQUIVALENT PROJECT
WITH ALL OF THE CELL -BASED
THERAPIES AND THE RFI THAT WAS
ON THE STREET IT CLOSED RECENTLY
BUT THEY WERE BUT NOW THERE IS A
WORKSHOP THE LEADS BEHIND THE
GROUP AND IT'S COMING UP IN
EARLY NOVEMBER DONE IN
COLLABORATION WITH FDA AND THE
FOUNDATION TO PUT TOGETHER THE
PUBLIC PRIVATE PARTNERSHIPS.
SO WE ARE REALLY EXCITED TO SEE
WHERE THAT LEADS.
IS THERE ANYTHING TO ADD?
>> NOT A LOT WE CAN SAY.
BUT THE WORKSHOP HAS 2
COMPONENTS IN 1 IS TO SHOW THE
SUCCESSES AND THE CHALLENGES
INVESTIGATORS FACE TO HELP
INFORM THE CAMP.
AND THEN TO FOCUS ON 1 CELL TYPE
AND THEN LOOKING AT THE
DIFFERENT CELL TYPES AND WHAT WE
WILL SUGGEST TO FOCUS ON.
THERE IS A LOT MORE TO COME BUT
IT IS PARTNERSHIP SO WE HAVE
INDUSTRY PARTNERS AND PATIENT
ADVOCACY GROUPS AND PEOPLE CAN
CONTRIBUTE DOLLARS OR IN KIND.
ON THE VISION COMMUNITY IS
POISED TO DO WELL.
AND THERE IS A PROGRAM.
>> AND THEN TO INVOLVE THOSE
DIAGNOSTICS AND WITH THE PROGRAM
OFFICER WITH THOSE INITIATIVES.
IT IS QUANTUM SENSING.
BUT THERE WERE NOT THAT MANY
INSTITUTES.
SO IT WAS NCI AND US.
SO THE BACKGROUND HERE IS THAT
QUANTUM SENSORS WITH PH
TEMPERATURE OR OPTICAL SIGNALS
WITH MUCH LESS POWER AND SIZE
THAN TRADITIONAL METHODS SO
THAT'S A POTENTIAL FOR MORE
EQUITABLE DATA COLLECTION AND
PORTABLE DEVICES.
THERE ARE SOME REAL WORLD
APPLICATIONS SO WITH AN EI OUR
FOCUS IN THIS SPACE IS NUMBER 1
NOVEL QUANTUM IMAGING SYSTEMS TO
IMPROVE DIAGNOSIS DETECTION OF
DISEASES.
AND SECOND IS QUANTUM COMPUTER
ALGORITHMS THAT CAN IMPROVE
DIAGNOSIS AND DETECTION OF
DISEASE.
THE OTHER THING I WANT TO
HIGHLIGHT AND TONY HAS DONE A
TON OF WORK ON IS BASICALLY
PROGRAM TO SUPPORT TRANSITIONAL
RESEARCH SO THE IDEA TO
TRANSLATE LABORATORY RESEARCH
INTO A THERAPEUTIC PROGRESS TO
TREAT VISUAL DISORDERS SO THESE
PRODUCTS CAN BE ON THE SPECTRUM
OF BIOLOGICAL PRODUCTS OR
PHARMACOLOGICAL PRODUCTS OR
MEDICAL DEVICES OR A COMBINATION
SO THIS IS A TWO-PART STAGE
TOWARDS WERE THE FIRST 1 IS OUR
61 MECHANISM.
AND WITH 500,000-DOLLAR COST PER
YEAR.
MOVING INTO THE ARE 33
MECHANISM.
IT IS $1 MILLION PER YEAR.
SO THAT SOMETHING WE ARE EXCITED
ABOUT WITH TRANSITIONAL -- --
TRANSLATIONAL RESEARCH.
ANOTHER AREA OF INNOVATION I
WANT TO HIGHLIGHT IS HEALTH
DISPARITIES RESEARCH.
A PERSON IS LEADING A LOT OF
THESE INITIATIVES.
AND WITH THIS NIH WORK WITH
HEALTH DISPARITIES CAUSED BY
DISABILITIES.
IT IS CALLED UNDERSTANDING AND
MITIGATING HEALTH DISPARITIES
EXPERIENCED BY PEOPLE WITH
DISABILITIES CAUSED BY ABLE IS
AM SO TO UNDERSTAND THE
MECHANISMS ON ABLE IS AM WITH
HEALTH OUTCOMES.
AND THEN TO LOOK AT
INTERVENTIONS AND THEN COMMUNITY
LEVELS THE OTHER THING I WANT
YOU TO MAKE SURE YOU ARE AWARE
OF IS NIH IS A MISSION STATEMENT
AND RIGHT NOW WE ARE DOING AT
THE NIH LEVEL IS SEEKING PUBLIC
COMMENT AND INITIATIVE TO REMOVE
THE LANGUAGE TO REMOVE
DISABILITY FROM THE MISSION
STATEMENT SO ON THIS SLIDE THERE
IS THE CURRENT MISSION AND BELOW
THAT IS THE PROPOSED REVISION TO
SEEK FUNDAMENTAL KNOWLEDGE OF
THE NATURE OF BEHAVIOR AND THE
APPLICATION OF THAT KNOWLEDGE TO
ENHANCE HEALTH, LENGTHEN LIFE
AND REDUCE ILLNESS AND
DISABILITY.
AND TO PROPOSE A CHANGE IN A FEW
AREAS.
AND THEN TO PREVENT AND REDUCE
ILLNESS.
SO I WANT TO PAUSE IF THERE ANY
COMMENTS?
>> FIRST OF ALL THANK YOU FOR
RAISING IT AND ASKING FOR
COMMENTS.
SECOND YOU HAVE PUT YOUR FINGER
ON THE POLLS THE NEXT GENERATION
IN TERMS OF PEOPLE COMING INTO
DISABILITIES BECAUSE WE ARE AT
THE POINT WHERE WE UNDERSTAND
AND RECOGNIZE THE BREADTH OF
DIVERSITY THAT IS ENCOMPASSED
UNDER THE TERM DISABILITY AND
MANY THOSE DO NOT LOOK AT
DISABILITY THE BACK OF MY CELL
PHONE IS A PIECE OF ARTWORK
CREATED BY A WOMAN OUT OF
VANCOUVER IT IS A STICKER THAT
SAYS DISABILITY IS NOT A BAD
WORD SUGGEST TO ENGAGE IN THIS
EXERCISE.
THANK YOU HAVE HELPED TO ADVANCE
THE CONCEPT THAT DISABILITY IS
IN FACT NOT A BAD WORD AND THOSE
THAT I IDENTIFY AS DISABLED IT
IS NOT LESSER THAN.
SO THANK YOU SO MUCH FOR THAT.
>> THANK YOU FOR THAT
PERSPECTIVE I HOPE YOU AND
PEOPLE IN THE COMMUNITIES AND
CONSIDER TO RESPONDING TO THIS
RFI.
>> LET ME MOVE ON.
THIS NEXT SLIDE DEALS WITH 2
PROGRAMS AND THE FIRST 1 IS T30
2 PRE- DOCTORAL TRAINING PROGRAM
CALLED ADVANCED AND IT AIMS TO
TRAIN PRE- DOCTORAL STUDENTS
FROM DIVERSE BACKGROUNDS TO
CONDUCT HEALTH DISPARITIES IN
HEALTH RESEARCH AND IMPLEMENT
AND EVALUATE PREVENTATIVE
INTERVENTIONS AND THE SECOND
PROGRAM IS CALLED HEALTH AND
HEALTH CARE DISPARITIES AMONG
PEOPLE LIVING WITH DISABILITIES
AND THE LEAD PROGRAM OFFICER ON
THIS SO LET ME GIVE A LITTLE BIT
OF BACKGROUND.
RECENTLY YOU WILL RECALL A FEW
MEN MONTHS AGO WE HELD A
WORKSHOP WITH A GROUP OF OUR
PROGRAM OFFICERS.
TO RECENTLY DESIGNATE PEOPLE
WITH DISABILITIES AS A
POPULATION WITH HEALTH
DISPARITIES AND WHO ARE THE
OTHER GROUPS THEY ARE RACIAL
MINORITIES PEOPLE WITH LOW
SOCIOECONOMIC STATUS AND PEOPLE
FROM RURAL PARTS OF THE COUNTRY
AND GENDER MINORITIES.
SO THE DECISION TO DO THIS WAS
MADE IN CONSULTATION THE AGENCY
FOR HEALTHCARE RESEARCH AND
THERE WAS A REPORT TO THE
ADVISORY COUNCIL THAT LED TO
THIS DECISION.
BUT THIS DESIGNATION WITH PEOPLE
OF DISABILITIES AND POPULATION
WITH HEALTH DISPARITIES IS 1 OF
THE STEPS NH HAS TAKEN WITH THE
ISSUES THAT YOU RAISED AND TO
MAKE SURE THEY ARE REPRESENTED
WITH NIH RESEARCH.
SO AGAIN THAT RATIONAL IS TO
ENCOURAGE RESEARCH THAT IS
SPECIFIC TO HEALTH ISSUES AND
THE UNMET NEEDS SO WITH THAT
INTRODUCTION IT IS FOCUSED ON
NOVEL AND INNOVATIVE
APPLICATIONS AND INTERVENTIONS
THAT ADDRESS THE INTERSECTING
IMPACT OF RACE AND SOCIAL
ECONOMIC STATUS AND HEALTH CARE
ACCESS AND HEALTHCARE OUTCOMES.
IF ANY OF YOU HAVE COMMENTS ARE
THERE PROJECTS YOU ARE AWARE OF
TO BENEFIT FROM THIS OPPORTU
OPPORTUNITY?
AND HOW DO WE ENCOURAGE
POTENTIAL INVESTIGATORS WITHIN
THE VISION COMMUNITY TO APPLY FOR A PROGRAM LIKE THIS?
I HAVE MORE OF A QUESTION
THEN AN ANSWER WHEN WERE THESE
PROGRAMS ANNOUNCED?
BECAUSE WHEN YOU HAVE SOMETHING
THAT'S VERY NEW FROM THAT
INVESTIGATOR INITIATED RESEARCH
ANY TIME TO PLAN FOR IT SO IT
MAY END UP HAPPENING IF YOU
DON'T HAVE ENOUGH TIME TO PLAN
WITH A NEW WAY OF THINKING THEN
THE NH MAY FEEL COMPELLED TO
GRANT APPLICATIONS THAT MAY NOT
NORMALLY BE COMPETITIVE.
>> YOU KNOW THE ANSWER TO WHEN
THIS WAS ANNOUNCED?
ACTUALLY IS ON MY DESKTOP I'VE
BEEN MEANING TO POST TO
SOMETHING TO SOCIAL MEDIA BUT I
HAVE NOT GOTTEN AROUND TO IT Y
YET.
>> IT WAS RECENTLY PUBLISHED THE
HEALTH AND HEALTH CARE
DISPARITIES BUT IT WILL BE
ACTIVE FOR 3 YEARS.
THERE IS A LOT OF TIME AND
OPPORTUNITIES TO DEVELOP
PROJECTS TO GET THOSE
COLLABORATIVE TEAM TOGETHER AND
THE LAST WAS OCTOBER OF 2026 SO
THAT HELPS WHEN YOU ARE
PRESENTING IT IS NOT JUST THE
DIAGNOSIS BUT THE EARLY
DETECTION AND THAT COULD BE AN
EARLY PREDICTOR AND THEY WANT TO
TRY TO DO MORE IMAGING SO THE
CIRCLE SOUL CLINIC HAS AN ACTIVE
COMPONENT TO DEAL WITH DRUGS FOR
PRAYING -- -- FOR PAIN.
SO THEY CRACKDOWN ON HOW MUCH
PAIN MEDICATION FOR PATIENTS AND
WITH SICKLE-CELL YOU ARE THE
EMERGENCY AND THEN 2 DAYS LATER
YOU'RE BACK INTO ER.
WITH ETHNICITY RACE AND I
DISEASE COME TOGETHER.
AND TO MAKE THAT AWARE OF THEM.
>> AND JUST TO TAKE THAT FROM
THE OPPOSITE TO TALK ABOUT A
DESIGNATION.
I HEARD IT FROM HIS LIPS IT WAS
THE FIRST TIME I HEARD ABOUT IT
CREATING TRAN TREMENDOUS
EXCITEMENT WITH THE COMMUNITY
ORGANIZATIONS WITH THE LACK OF
AVAILABLE DATA AND QUALITY OF
LIFE OF TREATMENT FOR PEOPLE
WITH DISABILITIES BUT WE ENTERED
AN AREA WITH RESPECT TO WOMEN'S
RIGHTS NOW THERE ARE 21 STATES
THAT THE AN ABORTION AND THAT
IMPACTS MORE THAN 35 WOMEN IN
REPRODUCTION IS IN AND 35 STATES
AND NOW PRESUMED TO BE UNFIT TO
PARENT WITH THE DISABILITIES OF
THE POTENTIAL FOR COLLABORATION
FOR THOSE ORGANIZATIONS THAT ARE
SEEKING TO EXPLORE THE
RAMIFICATIONS OF THE EXISTING
SITUATION SEEMS TO BE TREMENDOUS
AND THE PRESIDENT HAS SPOKEN SO
POSITIVELY OF THE AS A DISPARITY
THAT MEANS YOU CAPTURED THE
NONSCIENTIFIC COMMUNITY SO HOW
DO WE MATCH THE SCIENTIFIC?
>> I DON'T HAVE AN ANSWER TO
YOUR QUESTION I THINK THIS IS A
GREAT IDEA.
I WANT TO MAKE A COMMENT GOING
BACK TO RACE AND ETHNICITY AND
SOCIOECONOMIC STATUS IS THERE A
WAY WE CAN COLLECT DATA FOR THE
REQUIRED FORM THAT WE FILL OUT
DOESN'T MENTION SOCIAL ECONOMIC
STATUS OF HOW I WOULD MEASURE
THAT.
THESE ARE IMPORTANT THINGS WHEN
IS IT APPROPRIATE TO GET THE
DATA?
IT SEEMS LIKE IT'S A BIGGER
DISCUSSION.
THERE IS A CALL FOR SOMETHING
MORE CONVENTIONAL.
WHO I HAVE BEEN EXPOSED TO TO
REALLY IMPROVE ACCESS AND HEALTH
OUTCOMES.
AND IT WAS BACKGROUNDS AND
NURSING OR SOCIAL WORK.
AND SHE HAS HIGH FOCUS AND DOES
INCREDIBLE WORK AND IMPROVING
QUALITY OF LIFE.
SO I THINK A LOT OF THIS WORK
HAS TO BE DONE COLLABORATIVELY.
OR THOSE A CERTAIN RACIAL GROUPS
AND THEN MESHING THAT WITH THE
INTERVENTION.
AND THOSE THAT HAVE VISUAL
DISABILITIES.
IT HAS TO BE A COLLABORATIVE
WORK.
SO HOW DO YOU REACH OUT TO THOSE
OTHER GROUPS I THINK THAT'S
IMPORTANT.
>> THANK YOU FOR THOSE
COMMENTS.
SO IN TERMS OF WHAT YOU SAID
IT'S IMPORTANT TO REACH OUT TO
PEOPLE.
OTHERWISE WE ARE A TREE FALLING
IN THE FOREST.
OF PEOPLE WHO NEED TO KNOW ABOUT
THIS DON'T KNOW ABOUT IT, THANK
YOU FOR YOUR WORK TO SOCIALIZE
THIS OBVIOUSLY WE TRY TO
SOCIALIZE AS WELL.
AND THE OTHER THING IN TERMS OF
WHAT YOU SAID, THE WHOLE CONCEPT
OF THE EYE TO THE BODY IT'S A
GREAT SAYING BUT IT'S NEVER AS
TRUE AS IT IS NOW BECAUSE OF
TECHNOLOGIES AND IS INTERESTING
THAT THERE IS REAL POTENTIAL NOW
LIKE THERE HAS NEVER BEEN
BEFORE.
I THINK POTENTIALLY IT'S VERY
EXCITING.
>> 1 IDEA THAT POPPED UP TO
SCHOOLS OF PUBLIC HEALTH THESE
HAVE BEEN MUCH MORE INFLUENTIAL
ALTHOUGH THERE ARE SCHOOL OF
MEDICINE FACULTY LOOKING MORE
THESE ISSUES FOR THE SCHOOLS OF
PUBLIC HEALTH AND THAT IS A
NATURAL CONSIST - - CONSTITU
CONSTITUENCY.
>> SO BACK TO FOSTERING
COLLABORATIONS AND DATA SHARING
IS 1 THING.
I KNOW THAT WE HAVE DISCUSSED
THIS AT LENGTH AND IN FACT WHEN
WE'RE DONE DISCUSSING IT SO WHAT
I TAKE FROM THIS IT IS A SOURCE
OF A LITTLE BIT OF ANGST AND
FRUSTRATION AND WE TOTALLY GET
THAT AND THE WAY THAT I PUT IT
TOGETHER IS THAT OUR DATA
SHARING POLICY AND THE WHITE
HOUSE GUIDANCE ARE STICKS AND I
BELIEVE VERY FIRMLY THAT
DEVELOPING CARROTS IN ADDITION
IS 1 OF THE THINGS WE NEED TO
MOVE THE FIELD FORWARD.
WE GET THERE ARE LIMITED
INCENTIVES TO SHARE THE
WELL-DOCUMENTED DATA AND I WOULD
ARGUE SOMETIMES INVESTIGATORS
FIELD IS INCENTIVIZED TO SHARE
WITH OTHERS.
SO WE HAVE BEEN DISCUSSING THIS
A LOT SO THE LEADS ON THIS AND
THE GOAL IS TO DEVELOP AND
VALIDATE QUANTITATIVE SHARING
WHICH I DID NOT REALIZE IT IS AS
NEW AS IT IS TO IDENTIFY AND
REWARD EXEMPLAR DATA SHARERS
DESIGNATE SHARED OR USED BY
OTHERS?
AND THIS IS A MECHANISM TO
IDENTIFY AND SUSTAIN HIGH
QUALITY DATA SETS SO THE GOAL IS
TO CONDUCT A CHALLENGE AND THE
PEOPLE WHO ARE REALLY WORKING TO
COORDINATE THIS AND THE
RATIONALE ESSENTIALLY IT IS A
CARROT TO INCENTIVIZE
SELF-DIRECTED CHANGE.
AND WHO WOULD WE COLLABORATE
WITH PUBLISHERS OR DATA INDEXERS
AND I THINK THE CHANGES CREATING
GOOD DATA SETS IS LEGITIMATE
PRODUCT OF RESEARCH STUDIES AND
NOT JUST A TAGALONG.
THIS IS SOMETHING THAT CARRIE
AND AMBER REALLY PUSHED TO LOWER
THE BARRIER TO ENTRY FOR THOSE
WHO DON'T NORMALLY APPLY FOR
GRANTS TO APPLY FOR THE
CHALLENGE COMPETITIONS.
SO WE PRESENTED THIS TO SOME OF
THE LEADERSHIP AND THEY TRIED TO
GET US TO GET MORE PEOPLE
INVOLVED.
'S A RIGHT NOW THERE'S A GROUP
OF PARTNERS WITH THE NATIONAL
LIBRARY OF MEDICINE INITIATIVE
AND OFFICE OF DATA SCIENCE AND
OFFICE DIRECTOR AND CHILD HEALTH
AND MENTAL HEALTH AND A FEW
OTHERS.
AND THROUGH THE INTER AGENCY
AGREEMENT WITH NASA.
AND SO TO GO FROM LANDSCAPE
ANALYSIS TO LAUNCH THE ACTUAL
CHALLENGE.
AND THEN WE ARE SEEKING INPUT
ABOUT THIS.
>> I JUST WANT TO ENCOURAGE
ANYONE AND INTERVIEWING
DIFFERENT PARTIES AND THIS IS A
CHALLENGING TOPIC.
AND THOSE TO INCENTIVIZE AND
CREATE METRICS AROUND.
AND WITH THE INDEX POTENTIAL AND
WHERE WE MIGHT RUN INTO HURDLES
AND THEN PLEASE REACH OUT TO ME
AND I'M HAPPY TO PUT YOU IN
TOUCH.
>> WITH THE CEREBRAL VISUAL
IMPAIRMENT OR CVI WE HAVE BECOME
VERY INTERESTED IN THIS CAME OUT
WITH THE STRATEGIC PLANNING
PROCESS THAT THERE ARE SO MANY
UNANSWERED QUESTIONS IN THIS
AREA.
WHAT WE HAVE TALKED ABOUT IN
THIS GROUP CVI IS THE LEADING
CAUSE OF CHILD BLINDNESS IN THE
US.
A LOT OF UNKNOWNS.
HOW TO DIAGNOSE, CLASSIFY THAT
WE REALLY HAVE TO FIGURE OUT AS
A COMMUNITY.
THE PEOPLE INVOLVED TEND TO BE
PEDIATRICIANS, NEUROLOGIST AND
EYE DOCTORS.
OFTEN PATIENTS ARE BOUNCED BACK
AND FORTH BETWEEN THE GROUPS IT
IS THE EYE PROBLEM THAN THEY SAY
IT IS A BRAIN PROBLEM AND THEN
THEY GO BACK.
THIS HAPPENS ALL THE TIME.
SO IN THAT SPIRIT SO BASICALLY
WE ARE PLANNING A WORKSHOP WITH
THIS TOPIC COMING UP NEXT MONTH.
THIS IS TAKEN A YEAR AND A HALF
TO PLAN AND GET TO THE STAGE.
-- -- THIS STAGE.
AND THE COMMUNITY INVOLVES
PEOPLE FROM MULTIPLE
CONSTITUENCIES AND I CHD AND
CHILD HEALTH AND AND I NDS.
SO IN THAT SPIRIT DIFFERENT
PARTIES TAKE CARE OF THESE KIDS
SO THE COCHAIRS THEY ARE REALLY
GOOD ONES MELINDA AT USD
CHILDREN'S HOSPITAL LOS ANGELES
IS A PEDIATRIC OPHTHALMOLOGIST
DOING WORK AT THE INTERFACE AND
A VISION SCIENTIST AT HARVARD
WHO WAS OPTOMETRIST BY
BACKGROUND AND WHO RUNS A LAB
THAT STUDIES VISION
REHABILITATION AT HARVARD
MEDICAL SCHOOL SO BOTH PUT
TOGETHER A GREAT GROUP.
SO THE DESIGN OF THE WORKSHOP
AND THE GOAL IS TO MOVE TOWARD
BUILDING A REGISTRY FOR CVI AND
THEN TO CONTAIN DATA FOR
RETROSPECTIVE ANALYSIS.
SO A LOT OF QUESTIONS WHAT GOES
INTO THIS REGISTRY.
SO IT IS A 2 DAY WORKSHOP.
DAY NUMBER 1 IS IN PERSON CLOSED
MEETING BASICALLY THE PURPOSE IS
TO BUILD CONSENSUS.
BASED ON IDEOLOGY AND TO
DETERMINE WHAT ARE THE CRITERIA
DIAGNOSTICS AND METRICS AND
TESTING PARAMETERS NEEDING TO
REACH DEFINITIONS?
SO DAY TO IS TO TRY TO DEVELOP
PROTOCOL FOR CVI REGISTRY?
THAT IS THE IN-PERSON MEETING IN
BETHESDA THAT IS A WEBCAST.
HERE IS THE LIST OF INVITED
PARTICIPANTS DAY TO IS BIGGER
INCLUDING PEOPLE FROM DAY NUMBER
1 AND CVI, TEAC
CVI, TEACHERS, PEDIATRICIANS, OT
AND OCCUPATIONAL THERAPIST AND A
MULTIDISCIPLINARY GROUP.
SO THE GOAL ON THE SECOND DAY IS
TO DISCUSS CVI ELEMENTS AND
STANDARDS.
SO WE ARE TOTALLY WILLING TO
HELP AND THEY WILL BOTH BE
SPEAKING DURING THE NUMBER 2.
SO I WANTED TO MAKE YOU AWARE OF
THIS AND THE WORKSHOP COMING
UP.
THE OTHER THING I WANT TO
HIGHLIGHT IN THE SPIRIT OF
FOSTER COLLABORATION IS QUALITY
OF LIFE.
WE HOLD THE WORKSHOP A FEW WEEKS
AGO ON THIS THE PATIENT REPORTED
OUTCOMES AND QUESTIONNAIRES.
THE LEADS ON THAT, I KNOW THEY
DID A TON OF WORK ON THIS
BECAUSE THEY FLOODED MY INBOX
WITH A LOT OF E-MAILS ABOUT
THIS.
WHICH WAS FANTASTIC.
THE PREMISES WE HAVE THE MISSION
STATEMENT.
AND 1 OF THE CHALLENGES WE WANT
TO IMPROVE PEOPLE'S HEALTH AND
QUALITY OF LIFE THAT WE CANNOT
MEASURE VISION RELATED QUALITY
OF LIFE VERY WELL AND THEY'RE
NOT VERY GOOD INSTRUMENTS FOR
THIS.
SO THE INTENT OF THE WORKSHOP IS
TO HIGHLIGHT THE IMPORTANCE OF
PATIENT PERSPECTIVE AND PATIENT
REPORTED OUTCOMES AND ALSO
QUESTIONNAIRES FOR VISION
RELATED QUALITY OF LIFE AND
CLINICAL CARE.
AND WHO WAS INVOLVED WITH THIS?
WE TOGETHER WITH THE FDA WERE
COHOST AND CO- ORGANIZERS.
IN THE ORGANIZING COMMITTEE AND
HAS A LOT OF EXPERTISE IN THIS
AREA.
AND THE AMERICAN ACADEMY OF
OPHTHALMOLOGY WAS INVOLVED THEY
HAVE A LOT OF INTEREST TO
MEASURE QUALITY OF LIFE SO THE
GOAL OF THE WORKSHOP IS TO
IDENTIFY FUTURE STEPS WITH PRL
AND VFQ FOR OCULAR CONDITIONS
OVER THE PAST FEW YEARS I HAVE
GOTTEN A LOT OF COMMUNICATION
FROM GROUPS SOME OF THOSE DO
RARE DISEASES SOME DO COMMON
DISEASES BUT RARE MANIFESTA
MANIFESTATIONS.
AND THE COMMENT I HAVE ALWAYS
HEARD, CAN WE DEVELOP QUALITY
AND OUTCOME MEASURES AND ARE
SPECIFIC TO MY SCENARIO?
AND 1 OF THE CHALLENGES IS THAT
IT CAN TAKE LONGER TO VALIDATE
THE METRICS AND IT IS TO DO THE
RESEARCH.
I THINK IT WOULD BE AMAZING IF
PROBABLY TO GENERATE -- --
GENERALIZE A VISION INSTRUMENT
WITH QUALITY OF LIFE WORKING
ACROSS DIFFERENT DISORDERS OR
PERHAPS THERE IS A MENU OF
PATIENT REPORTED OUTCOMES AND
THEN TO BE LINKED BUT WE WILL
SEE WHERE THIS LEADS FOR WE ARE
EXCITED ABOUT THAT.
AND WITH THE EXPERTISE IN THIS
AREA.
SO ASKING FOR YOUR COMMENTS WHAT
CHALLENGES DO YOU HAVE?
AND MANY OPEN IT UP FOR
DISCUSSION.
>> I THINK THIS IS A GREAT TOP
TOPIC.
I THINK 1 OF THE CHALLENGES IS
TO HAVE A CONSENSUS FROM WHAT
HAS BEEN TAKEN FROM OUR
PATIENTS.
AND THEN TO UNDERSTAND WHAT WE
ARE LOOKING FOR.
I CONGRATULATE YOU FOR WORKING
WITH THE FDA.
AND THEN ALSO WITH THE QUALITY
OF LIFE.
>> THANKS FOR PUTTING ON A GREAT
AND BRINGING IN A LOT OF
STAKEHOLDERS AND THE ACADEMIC
STAKEHOLDERS AND IT BROUGHT IN
THE SCIENTIST WHO GOT INTO THE
DEEP WEEDS OF QUALITY OF LIFE.
THERE WAS A LOT OF CHALLENGES TO
IT.
HOW DO EVEN SELECT WHICH 1 OR
HOW DO WE INTEGRATE THEM ALL?
AND THEN THE THINGS THAT HOLD IT
BACK LIKE REPRODUCIBILITY AND
ACCURACY OF THE ABILITY TO ADAPT
THEM.
OR HAVE POOR HEARING.
THERE IS A NUMBER OF
CHALLENGES.
I HOPE THE SUMMARY OF THIS
WORKSHOP WILL HOPEFULLY LEAD FOR
CALLS OF PROPOSALS TO MOVE THE
SCIENCE FORWARD.
I THINK IT WOULD BE TERRIFIC IF
THE FIELD COULD COALESCE AROUND
SOMETHING OF A COMPUTER-BASED
SYSTEM TO CHOOSE THE DOMAIN AND
ESSENTIALLY GAVE YOU THAT
QUALITY OF LIFE FOR WE HAVE A
WAYS TO GO BEFORE IT GETS THERE.
>> THIS AREA IS VERY
COMPLICATED.
AND 1 ASPECT BROUGHT UP DURING
THE CONFERENCE THAT IS IMPORTANT
IS TO SURVEY THE PATIENT WITH
RESPECT TO WHAT ARE YOU HAVING
DIFFICULTY WITH?
JUST ASKING A LAUNDRY LIST OF
THINGS CAN YOU DO THIS OR NOT DO
THIS DOES NOT CAPTURE A LOT OF
WHAT IS GOING ON FOR THE
PATIENT.
I WORD ENCOURAGE EMPHASIS ON
PERSONALIZING THROUGH
STANDARDIZED METHODS TO
PERSONALIZE FOR THE PATIENT.
>> A VERY IMPORTANT TOPIC.
I WANT TO SECOND THE COMMENTS IN
REGARD TO HOPEFULLY THE ABILITY
TO INFLUENCE THE FDA OBVIOUSLY
IS NOT THAT INTERESTED IN
QUALITY OF LIFE WITH
TRANSLATIONAL INVESTIGATIONS AND
PRIMARY INFLUENCE.
THERE ARE MANY EXAMPLES IN
OPHTHALMOLOGY YOU CAN HELP
PATIENTS HAVE BETTER QUALITY OF
VISION AND QUALITY OF LIFE IS
MEASURED WITH THOSE METRICS AND
VFQ THAT DO NOT IMPACT SO THAT
IS A SIGNIFICANT BARRIER FROM
THE LEVEL OF THE FDA.
>> THANK YOU TO ALL OF YOU.
ANY OTHER COMMENTS?
ANOTHER EXAMPLE OF QUALITY OF
LIFE INVOLVES A PROJECT THAT IS
BASED IN INDIA.
THE BACKGROUND IS A FEW MONTHS
AGO THERE WAS A CALL FROM HHS TO
IDENTIFY PROJECTS GLOBALLY THAT
COULD BE OF INTEREST FOR THE
SECRETARIES TEAM TO VISIT SO OUR
DIRECTOR OF INTERNATIONAL
PROGRAMS SUGGESTED NOMINATING
PROJECT PRAKASH.
NO RELATION.
WE DID THAT AND I GOT PICKED SO
NOW I'M OFF TO INDIA ON 8 DAYS
NOTICE.
IT'S NOT EASIER TO GET TO INDIA
ON 8 DAYS NOTICE WITH THE VISA
PROCESS BUT THE TEAM WAS AMAZ
AMAZING.
THEY WERE FRUSTRATED BUT IT
HAPPENED.
IT WAS AN AMAZING TRIP FOR ME TO
SEE WHAT WAS HAPPENING ON THE
GROUND LEVEL.
THEY DID COME AND VISIT.
BUT THE PEI - - THIS PROJECT HAS
BEEN ANY I FUNDED OVER 15
YEARS.
AND THE GOAL OF PLASTICITY OF
VISION LOSS FROM CATARACTS AND
OTHER DISEASES IT HAS BEEN FELT
FOR A LONG TIME THAT IF YOU HAVE
DEPRIVATION PAST AGE 7 AND
CATARACTS CANNOT HEAR MUCH
EARLIER THAN THE VISION LOSS IS
UNTREATABLE.
BUT THERE ARE THE CRITICAL
PERIODS OF DEVELOPMENT.
BUT THE DESIGN OF THIS PROJECT
IS BASED OUT OF THE EYE CHARITY
HOSPITAL AND THEY DO
INFRASTRUCTURE FOR VISION
SCREENING OFTEN IN RURAL AREAS
TO IDENTIFY KIDS WITH BLINDNESS
FROM CONGENITAL CATARACT, BRING
THEM IN TO DO THE SURGERY.
AND THEN FOR THE FAMILIES WHO
CONSENT TO BE FOLLOWED, THEY
FOLLOW THE VISUAL DEVELOPMENTS
AFTER SURGERY.
AND THEY HAVE LEARNED A LOT
INVOLVING PLASTICITY.
WHAT THEY FOUND IS THESE KIDS
DEMONSTRATE IMPROVEMENTS AFTER
CATARACT SURGERY.
NOT IN VISUAL ACUITY BUT FACE
PERCEPTION, BRIGHTNESS CONTRA
CONTRAST, SPATIAL AND TEMPORAL
CONTRAST SENSITIVITIES.
SOME OF THEM ARE GETTING JOBS
AFTER THIS.
AND THEY SHOWED THE PROGRAM
OFFICER AND KNOWS THE GROUP VERY
WELL GIVE ME A BUNCH OF PAPERS
ON THIS THAT SHOWED PLASTICITY
CHANGES AFTER CATARACT SURGERY
FOR WHITE MATTER.
AND IS GIVEN EVIDENCE TO MEASURE
HOW WE THINK OF CRITICAL PERI
PERIODS.
IN TERMS OF QUALITY OF LIFE THE
TAKE-HOME IS THAT TREATMENT WITH
SURGERY AND REHABILITATION AT A
LATER AGE CAN REALLY MAKE A
DIFFERENCE.
I THOUGHT THIS WAS INTERESTING
WORK AT THE INTERFACE OF VISUAL
AND NEUROSCIENCE AND HEALTH
DISPARITIES AND IT WAS EASY TO
SHOWCASE THAT IN THE SECRETARIES
OFFICE.
I ALSO WANT TO CALL ATTENTION A
CONCEPT PRIZE COMPETITION AT THE
PLANNING ACTIVITY IT IS
COMPLEMENT ANIMAL RESEARCH AND
EXPERIMENTATION SO LOOK AT THE
NEW APPROACH METHODOLOGIES.
IT COULD BE IN VITRO, AND
SILICONE OR INCOME ACCOUNT OR
SOME TYPE OF AI SYSTEM OR AN
ORGAN MODEL.
IT WOULD COMPLEMENT ANIMAL
MODELS TO BE A BETTER ANIMAL
RESEARCHER OR PERHAPS IN SOME
CASES REPLACE TRADITIONAL ANIMAL
MODELS.
BUT MARTHA IS HER LEAD ON THIS
ESPECIALLY NONHUMAN PRIMATE
RESEARCH.
BUT RIGHT NOW IS INFORMATION
GATHERING.
THIS HAS BEEN GOING ON FOR A
LITTLE WHILE.
BUT THERE IS A PREPUBLICATION
SITE THAT IS UP RIGHT NOW WITH
THE BASICS WE JUST TALKED
ABOUT.
THE CHALLENGE ANNOUNCEMENT WILL
COME OUT IN NOVEMBER 2023 AND IT
IS A QR CODE TAKING YOU FOR MORE
INFORMATION ABOUT THAT.
COMPLEMENT-ARIE FOR ANIMAL
MODELS.
SO THE NEXT FEW SLIDES ABOUT
RECRUITING AND INSPIRING AND
TRAINING TALENTED INDIVIDUALS.
SO THAT THE LAST COUNCIL MEETING
WAS STIMULATING ACCESS TO
RESEARCH AND RESIDENCY THANK YOU
FOR THIS -- -- ALL OF YOUR
COMMENTS.
WE OFFICIALLY SIGNED ON.
THE DEADLINE IS MARCH 2024.
SO THE GOAL OF THE PROGRAM IS TO
FACILITATE A PATH TO THE CAREERS
ALONG TRAINEES BY SUPPORTING
INSTITUTIONAL PROGRAMS AND
RESEARCH FOR RESIDENCY.
MR. FOR YOUR RESIDENCY IT
BECOMES A FIVE-YEAR RESEARCH
ORIENTED RESIDENCY PROGRAM.
SO FOR TRAINEES OPHTHALMOLOGY
AND VETERINARY TRAINEES THOSE
WHO ARE INTERESTED IN RESEAR
RESEARCH, AS PEOPLE ENTER THE
FIELD I AM HOPING TO MAKE SURE
THEY KNOW THE VISION OF FIELD IS
WHERE WE WANT CLINICIAN
SCIENTIST AND ARE WELCOMING TO
THAT.
I HOPE THIS MECHANISM IS A WAY
TO HELP DELIVER THAT MESSAGE TO
THE COMMUNITY.
THE OTHER THING I WANTED IS THE
ADMINISTRATIVE SUPPLEMENTS TO
PROMOTE DIVERSITY AND
HEALTH-RELATED RESEARCH.
THIS WAS A JOINT ON
ADMINISTRATIVE SUPPLEMENTS.
WHAT IS A TRAINEE?
IT COULD BE A HIGH SCHOOL
STUDENT AND POSTDOC RESEARCHER.
IF YOU COME FROM THE NIH DIVERSE
BACKGROUND SO WE HAVE BEEN
TRYING TO BUILD THE WORKFORCE.
ANOTHER EXAMPLE OF RECRUITING
TALENTED AND DIVERSE INDIVIDUALS
FOR 2 YEARS NOW, WE HAVE HAD A
VIDEO CONTEST CALLED EYE ON THE
FUTURE.
THE PURPOSE IS TO IDENTIFY HIGH
SCHOOL STUDENTS FROM AROUND THE
US AND GET THEM INTERESTED IN
SCIENCE, HEALTHCARE AND VISION
IN PARTICULAR.
THEY HAVE PUT A TON OF WORK INTO
THIS WHILE LEADING THIS.
THERE ARE 4 PICTURES TAKEN OF
HIGH SCHOOL STUDENTS WHO WERE AT
BETHESDA.
WE BRING THE WINNERS TO BETHESDA
FOR THE DAY.
IT IS A REALLY GOOD DAY WHERE
SOME OF IT IS SCIENCE.
THEY WILL DISSECT EYES FROM
ANIMALS AND SOME OF IT IS
NETWORKING WITH TRAINEES AND
SCIENTISTS AND CLINICIANS HERE
AT NIH AND T12 AND THE PICTURE
ON THE RIGHT IS THE ACTING
DIRECTOR WHO CAME TO THE PANEL
DISCUSSION OF EQUITY DIVERSITY
AND INCLUSION THAT NIH WE HAVE
HAD A LOT OF FUN WITH AND THEY
HAVE DONE A LOT OF WORK AND
THINGS LIKE THAT WE HOPE WILL
HELP BUILD A PIPELINE.
AND MY LAST SLIDE IS EDUCATING
ABOUT IS IN -- -- VISION
RESEARCH ADVANCES.
A FEW MONTHS AGO THERE WAS A
CALL FOR PROPOSALS FOR WHAT IS
CALLED AMERICAN POSSIBILITIES A
WHITE HOUSE DEMO DAY.
SO THEY WOULD SELECT PROJECTS
THAT SHOWCASED HOW RESEARCH AND
DEVELOPMENT ADVANCES AND
IMPROVES THE LIVES OF
AMERICANS.
SO THE TOPICS WERE NATIONAL
SECURITY AND INFORMATION
TECHNOLOGY AND AI AND INDUSTRIES
OF THE FUTURE AND HEALTH.
WHO WILL LISTEN TO THIS?
WHITE HOUSE STAFF CONGRESSIONAL
MEMBERS, ADMINISTRATION AND
INVITED MEMBERS OF THE
COMMUNITY.
SO WE SUBMITTED A PROJECT WITH
OCT.
WHO?
THE PEOPLE FROM THE CLINICAL
SIDE SO THIS PROJECT WAS PICKED
FOR OCT SO BASICALLY THERE WAS
SUPPOSED TO BE A TRIP ON THE
WHITE HOUSE LAWN BUT I THINK
THEY CHANGED IT BECAUSE IT IS
NOVEMBER AND MOVED IT INDOORS.
BUT REALLY THIS IS TRULY A
TECHNOLOGY THAT IS CHANGING OF
EYE CARE AND HEALTH CARE.
IT IS TIMELY THAT THIS
TECHNOLOGICAL THAT WE ARE
RECEIVING THE AWARD THIS YEAR SO
BASICALLY WE CAN SHOW THAT OFF A
LITTLE BIT.
EXCITED ABOUT THAT.
I WANT TO GIVE A BUDGET UPDATE.
KAREN IS OUR BUDGET OFFICER.
>> THANK YOU AND GOOD MORNING.
I AM THE BUDGET OFFICER IN
PLEASED TO BE HERE WITH YOU
TODAY TO GIVE A UPDATE I WILL
GIVE A RECAP ENDING LAST FISCAL
YEAR FROM SEPTEMBER 30th AND
SHARE THE BUDGET FOR THE CURRENT
FISCAL YEAR BEGINNING OCTOBER 1.
HERE WE HAVE ANY I ESTIMATED
SPENDING ACTIVITY FISCAL YEAR
2023.
THE BUDGET WAS 896.$1 MILLION
WHICH 32.$6 MILLION OR
3.8 PERCENT INCREASE OVER FISCAL
YEAR 2022.
ALTHOUGH FISCAL YEAR 23 HAS
CONCLUDED OFFICIAL TOTALS CANNOT
BE RELEASED UNTIL COLLECTED AND
THEN REPORTED TO HHS AND TO
CONGRESS.
THAT PROCESS WILL HAPPEN OVER
THE NEXT FEW WEEKS BUT WHAT IS
DISPLAYED HERE IS A GOOD
REPRESENTATION OF HOW WE ENDED
LAST YEAR.
THE PIE CHART TO THE LEFT SHOWS
THE PERCENTAGE OF THE FUNDING
SPENT WITH EACH MAJOR ACTIVITY.
THE RESEARCH PROJECT GRANTS AT
64 PERCENT WHICH IS THE LARGEST
PIECE OF THE BUDGET.
THE RESEARCH CENTER AT
3 PERCENT.
OTHER RESEARCH AT 9 PERCENT.
TRAINING AT 2 PERCENT.
RESEARCH AND DEVELOPMENT
CONTRACTS 5 PERCENT.
INTRAMURAL PROGRAMS 12 PERCENT.
RESEARCH SUPPORT 5 PERCENT.
THE BAR CHART SHOWS A HIGHER
LEVEL VIEW OF NEI SPENDING
DIVIDED INTO 3 MAJOR
CATEGORIES.
EXTRAMURAL RESEARCH AT
83 PERCENT.
INTRAMURAL RESEARCH AT
12 PERCENT.
RESEARCH SUPPORTED 5 PERCENT.
THESE FUNDING LEVELS ARE IN LINE
OF HISTORICAL TRENDS.
MOVING ON TO THE BUDGET CURRENT
FISCAL YEAR 24.
A COUPLE WEEKS AGO WE WERE
DANGEROUSLY CLOSE TO A SHUTDOWN
AVOIDED BY CONGRESS PASSING TO
ALLOW THE GOVERNMENT TO OPERATE
ON A CONTINUING RESOLUTION
GIVING CONGRESS ADDITIONAL TIME
TO RESOLVE APPROPRIATIONS.
THE CURRENT CR BEGAN OCTOBER FIRST
AND IS ENACTED THROUGH NOVEMBER
17 A TOTAL OF 48 DAYS.
ENACTED CR ASSUMES THE TOTAL OF
FUNDING OF $896 MILLION.
WHEN THE CR IS ENACTED WE DO NOT
RECEIVE THE FULL BUDGET FROM THE
FISCAL YEAR UNLESS IT IS PUT IN
PLACE.
SEARS CAN BE PUT IN PLACE FOR
HOURS, DAYS, WEEKS, MONTHS OR A
FULL FISCAL YEAR.
FUNDS ARE DIVIDED OUT MATCHING
THE NUMBER OF DAYS IN THE BILL
THE CURRENT CR THROUGH
NOVEMBER 17 FUNDS OPERATIONS FOR
48 DAYS.
IN THIS CASE THE MATHWORKS
$896 MILLION DIVIDED BY 365 DAYS
IS APPROXIMATELY $2.5 MILLION
PER DAY TIMES 40 DAYS IS
APPROXIMATELY $118 MILLION MADE
AVAILABLE TO MAINTAIN ALL T 12
OPERATIONS THROUGH NOVEMBER 17
AT WHICH POINT A NEW CR IS PUT
IN PLACE, RECEIVE APPROPRIATION
OR POTENTIALLY A SHUTDOWN WHICH
WE HOPE WILL BE AVOIDED.
FUNDS MADE AVAILABLE UNDER CR
AWARDS
GRANTS, CONTRACTS, INTRAMURAL
OPERATING EXPENSES AND SALARIES
AND BENEFITS AND MANDATORY COST
THAT IS FROM HAVING SECURITIES
SERVICES AND THE TRANSFER
SERVICES AND EDUCATION AND
CONTRACTING AND PROCUREMENT.
IT SERVICES AND EXTRAMARITAL
RESEARCH OVERSIGHT AND SYSTEM
SUPPORT TO THE PROGRAMS AND
OFFICES THAT DON'T ACTUALLY
RECEIVE APPROPRIATION FROM
CONGRESS OR FEE-FOR-SERVICE.
BECAUSE IT IS THE LARGEST
PORTION OF THE BUDGET WHEN
OPERATING UNDER THE CR THEY WILL
ISSUE GUIDANCE BUT EARLIER THIS
MONTH THE NOTICE WAS RELEASED
THAT GIVES NIH THE DISCRETION TO
REDUCE NONCOMPETING AWARDS FROM
THE MOST RECENT NOTICE OF
AWARD.
IT GIVES NIH FLEXIBILITY TO MAKE
ADJUSTMENTS THAT MATCH THE NEEDS
OF THEIR PORTFOLIOS.
IN THE PAST WE HAVE SEEN
GUIDANCE ALLOWING CUTS AT
10 PERCENT WHICH THEN HAS TO BE
RESTORED ONCE THE APPROPRIATION
IS ENACTED.
THE FINAL SLIDE AND IS A
SIDE-BY-SIDE COMPARISON OF NEI
2024 PRESIDENT BUDGET REQUEST.
BASED ON WHAT WE KNOW TODAY
PREDICTING A FLAT BUDGET FROM
LAST YEAR IS PROBABLY THE BEST
WE CAN EXPECT.
BUT A BUDGET CUT IS STILL
POSSIBLE.
IF CONGRESS DOES NOT SETTLE
APPROPRIATIONS AN ALTERNATIVE
OUTCOME COULD BE A FULL YEAR
CONTINUING RESOLUTION.
TO BE CLEAR A BUDGET WITH NO
INCREASE IS VIRTUALLY A CUT IN
FUNDING BECAUSE THE COST OF
DOING BUSINESS INCREASES EVERY
YEAR AND A MANDATORY COST
MENTIONED EARLIER WILL
INCREASE.
WITH THAT SAID WE ARE VERY
CONFIDENT IN OUR ABILITY TO
MANAGE WITHIN THE RESOURCES WE
WERE AFFORDED WITH THE
UNCERTAINTY THAT REMAINS IN
CONGRESS.
THE PROPOSED BUDGET PICTURE IS
DIFFERENT.
THE HOUSE BILL REDUCES THE TOTAL
BUDGET BY 3.$7 MILLION.
UNDER THIS SCENARIO THOSE
INSTITUTES ARE HELD FLAT THE
CUTS ARE TARGETED TO MANY
ORGANIZATIONS AND REDUCES
FUNDING BUT DOES NOT REPLACE IT
WITH NON- CARE MANY RESULTING IN
CANCER TOTAL.
THE CURE AND WITH 4.$8 BILLION
OVER A 10 YEAR PERIOD FISCAL
YEAR THROUGH 2026.
OVER THE LIFE OF THE PROGRAM
FUNDING HAS BEEN INCLUDED CANCER
MOONSHOT AND REGENERATIVE
MEDICINE.
THE HOUSE BILL PROPOSES TO BE
FUNDED AT $1 BILLION WITH FY
2023 LEVELS FOR LAST YEAR.
THE SENATE HOWEVER WITH THE
C.A.R.E.S. ACT FUNDING AND
PROPOSES 265 MILLION.
AND THAT FACTOR IMPACTING IF WE
RECEIVE A FULL YEAR
APPROPRIATION THERE IS NO
SPEAKER OF THE HOUSE.
IT SERVES A CRITICAL ROLE OF
NEGOTIATIONS WITH THE PRESIDENT
AND SENATE.
WITHOUT THAT ROLE PERMANENTLY
FILLED, CRITICAL PROCESS SUCH AS
FINALIZING APPROPRIATIONS AND
RESOLVING SUPPORT FOR OTHER
NATIONS SUCH AS UKRAINE AND
ISRAEL ARE DELAYED.
CURRENTLY WE ARE STILL ON
SHUTDOWN WATCH.
IF I HAD TO GUESS I WOULD SAY WE
WILL SEE AT LEAST 1 MORE
CONTINUING RESOLUTION BUT IT IS
HOW THE PROCESS PLAYS OUT.
SO TO WATCH IN CONGRESS.
SO THAT IS MY LAST SLIDE BUT I'M
HAPPY TO TAKE QUESTIONS.
>> THANK YOU VERY MUCH.
ANY QUESTIONS?
THINGS A LOT.
THERE IS A LOT GOING ON.
WE HAVE A FEW MINUTES DOES
ANYBODY HAVE COMMENTS OR
QUESTIONS IN THE LAST FEW
MINUTES?
SO NEXT IS A BREAK.
WE HAVE 15 MINUTES FOR A BREAK
PLEASE BE BACK HERE BY 1030 SO
WE CAN START THE NEXT SESSION ON TIME.
SOME HAVE TIME LIMITATIONS.
ENJOY YOUR BREAK.
STARTED MAKE YOUR WAY TO YOUR
SEATS.
WE WILL GO AHEAD AND GET
STARTED.
LET'S GET STARTED.
SO NOW WITH COLLABORATIONS.
WE WILL GO AHEAD AND GET STARTED
WITH THE NEXT SESSION.
AND THE TOPIC IS THAT WHAT WE
HAVE BEEN DISCUSSING ALMOST 2
YEARS NOW OF COLLABORATIONS
IDEAS BETWEEN AND EI AND THE ALL
OF US PROJECT.
BUT THAT IS AN AMAZING PROJECT.
AND WHAT WE HAVE BEEN EXCITED
ABOUT AND THE MEETINGS IN A
WORKSHOP HAVE -- -- RECENTLY
LEADING UP TO THIS.
THE PURPOSE OF THE SESSION IS TO
LET YOU KNOW WHAT HAS BEEN
HAPPENING ABOUT THIS.
EACH OF THE TALKS OR 15 MINUTES
WITH A FEW MINUTES OF DISCUSSION
AFTER THAT.
AND AFTER THAT IT LEAVES 30
MINUTES FOR DISCUSSION
AFTERWARDS.
SO WE REALLY WANT TO HEAR ALL OF
YOUR THOUGHTS AND FEEDBACK.
BUT IT'S NOT UP RIGHT NOW.
AND TO INTRODUCE THE 3 SPEAKERS
1 BY 1.
1 WAS THE CEO OF THE ALL OF US
PROJECT AND JOSH HAD AMAZING
ACADEMIC CAREER.
AND AT THE NIH A LITTLE OVER 3
YEARS.
AND TO TALK ABOUT THE ALL OF US
PROGRAM WITH THE OVERVIEW.
AND TO TALK ABOUT A WORKSHOP WE
HOPE TO LEAD FROM OUR
PERSPECTIVE WITH PEOPLE FROM ALL
OF US.
FROM THE BIOMEDICAL IMAGING AND
BIOMEDICAL - - AND THEN WE WILL
SPEAK ABOUT COMMON DATA MODELS
AND WORK WITH CARRIE AND SEVERAL
OTHERS INVOLVING DEVELOPING THAT
DATA MODEL AND STANDARDS SO THE
3 WILL GO 1 BY 1.
WELCOME.
>> IT IS A PLEASURE THANK YOU
FOR THE KIND INTRODUCTION WITH
THE WHOLE PROCESS LOOKING AT
THIS JOB RIGHT AFTER I HAD
JOINED AND I ENJOYED OUR
CONVERSATION AND WHAT WE SAW A
LOT OF POTENTIAL FOR IS WE ARE
EXCITED SO TALK ABOUT AN
OVERVIEW OF THE PROGRAM THEN WE
WILL TALK ABOUT THE WORKSHOPS I
WILL TEASE YOU WITH THAT AND LET
HER GO INTO DETAIL.
THIS WAS ENVISIONED PRESIDENT
OBAMA STATE OF THE UNION 2015
WORKSHOP PLANNING AND TO
ACCELERATE HEALTH RESEARCH AND
MEDICAL BREAKTHROUGHS AND
PREVENTION TREATMENT FOR ALL OF
US THOSE WERE CHOSEN
INTENTIONALLY TO REFLECT THE
DIVERSITY TO RECRUIT BROADLY
ACROSS THE UNITED STATES WITH AT
LEAST 1 MILLION PARTICIPANTS FOR
DECADES AND WE WANT TO TAKE THE
DATA SET AND TO PUT IT INTO HIS
HANDS AS MANY RESEARCHERS AS
POSSIBLE THAT ARE RELEVANT TO
THE BROAD POPULATIONS IN A SAFE
AND SECURE MANNER.
STARTING WITH NIH AND THEN TO
IMPROVE OR ACCELERATE RESEARCH
AND PROVIDE CERTAIN BENEFITS OF
SCALE AND ACCESSIBILITY TO
ESTABLISH CORE VALUES TALK ABOUT
TRANSPARENCY OR TRUSTOR DATA
AVAILABILITY TO FACILITATE THAT
LOOKING AT PARTICIPANTS FROM ALL
50 STATES AND TERRITORIES
INCLUDING DC YOU CAN SEE OUR
TOTALS LAUNCH NATIONALLY 2018.
PEOPLE PARTICIPATE IN DIFFERENT
WAYS YOU COULD NOT DONATE BIO
SPECIMEN WHEN WE STARTED AT
LEAST NOW YOU CAN GET A KIT WE
HAVE WAYS OF GIVING BLOOD.
THE PLACES THAT HAVE GREATER
REPRESENTATION IS LARGE ACADEMIC
OR OTHER HEALTHCARE SYSTEMS
RECRUITING.
AND OTHERS PART OF THE
RECRUITMENT EXERCISE YOU CAN SEE
500,000 HAVE COMPLETED THE
INITIAL SURVEYS NEVER AGREED TO
SHARE THE EHR.
POTENTIALLY FOCUSED ON DIVERSITY
AND DIFFERENT DOMAINS WITH THE
LITERATURE SURVEY OF HOW WE
DEFINE UNDERREPRESENTED
BIOMEDICAL RESEARCH AND THOSE
ARE THE CATEGORIES ON THE RIGHT
AND RACE AND ETHNICITY.
AND TARGETED OUR GOAL THAT
50 PERCENT OTHER THAN
NON-HISPANIC WHITE WE ARE A
LITTLE BIT OFF FROM WHERE WE
WANT TO GO BUT THAT WAS DURING
COVID THAT DROP DURING THOSE
TIMES.
AND THEN OTHER CATEGORIES OVER
80 PERCENT ARE PARTICIPANTS IN
AT LEAST 1 OF THESE DOMAINS.
IT IS ONGOING LONGITUDINAL
PROGRAMS.
WE LAUNCHED 1 OF THOSE AND THOSE
ARE PART OF THE CORE OR SURVEY
MODULES JUST A MODEL OF HOW WE
CAN EVOLVE THE RESOURCE OVER
TIME.
WE COLLECT THE SAME TYPES OF
DATA REGARDLESS OF WHO JOINS THE
PROGRAM WITH THE ELECTRONIC
HEALTH RECORDS AND WE RELEASE 1
NEW SURVEY A YEAR TO OUR
PARTICIPANTS WE DID A REPEATED
SURVEY DURING COVID WITH A CORE
SET OF PHYSICAL MEASURES IF YOU
COME IN PERSON WE COLLECT FOR
BLOOD AND PLASMA AND URINE AND
IF YOU WANT TO DONATE A BIO
SPECIMEN A SLIDE IS AVAILABLE WE
ALLOW PEOPLE TO PARTICIPATE IN
DIFFERENT WAYS NOT EVERYONE HAS
TO CONTRIBUTE OR SHARE EHR BUT
MOST DO A VAST MAJORITY DO.
PEOPLE CAN BRING THEIR OWN IF
THEY HAVE THE APPLE WATCH OR FIT
BIT.
AND ALSO WE HAVE 30000 FIT
BITS.
AND WE ARE GETTING READY TO GIVE
OUT ANOTHER 30000 OVER THE NEXT
YEAR.
SO THAT APPROACH SHOULD APPROACH
ABOUT 100,000 EITHER THEY OWN
THE FIT BIT OR THOSE THAT DONATE
THAT KIND OF INFORMATION SO
RETURNING VALUE IS A KEY PART OF
THE PROGRAM WE ASK PARTICIPANTS
WHY MIGHT YOU JOIN?
IN 17 CITIES WITH POTENTIAL
PARTICIPANTS AND TOP OF THE LIST
IS DIFFERENT FOR DIFFERENT
PEOPLE BUT IT WAS GENETIC HEALTH
INFORMATION BUT THERE ARE OTHER
KINDS OF THINGS IF THERE ARE
OTHER STUDIES BUT OVERALL THE
MOST IMPORTANT THING NO SURPRISE
IS ALTRUISM THE ABILITY TO MAKE
A DIFFERENCE.
SO WE WANT TO PROVIDE THOSE
STORIES AND PROVIDING THIS
INFORMATION IN SOME WAY SO I
WILL HIGHLIGHT ON THE GENETICS
PIECE THIS IS WHAT PARTICIPANTS
ARE MOST INTERESTED IN WITH THE
MOST INNOVATIVE PART OF THE
PROGRAM DOING WHOLE GENOME
SEQUENCES AND BASED ON THAT
DOING SOME ANCESTRY TRAITS
INFORMATION WHICH IS INTERESTING
INFORMATION THERE AND THE HEALTH
RELATED LAUNCH FROM LAST YEAR
INTO CATEGORIES.
THE 59 GENES THE SECONDARY
FINDINGS LIST THAT IS 2 OR
3 PERCENT OF THE POPULATION AND
HAVE A PATHOGENIC PERIOD IN 1 OF
THOSE 59 GENES AND HOW MANY
DON'T KNOW AND PHARMACOGENETICS
THERE ARE 7 GENES WITH THOSE
INTERACTIONS WE HAVE INFORMATION
ON WE ARE OVERSEEN WITH THE FDA
AND YOU CAN SEE 170,000 HAVE
RECEIVED THE RESULTS WE OFFER
THESE TO 5000 PEOPLE AND NOT
EVERYONE DECIDES THEY WANT TO
AND THAT IS FINE.
GENETIC COUNSELORS ARE AVAILABLE
TO ANYONE IN THE PROCESS OF
ENGLISH AND SPANISH AND
TRANSLATION SUPPORT OVER 200
LANGUAGES FOR ALL OF THE
POSITIVE RESULTS AND THEN HAVE
THE MEET WITH A GENETIC
COUNSELOR.
WE HAVE AMASSED LARGE DATA SET
AND NOW WE RELEASE 1 NEW DATA
SET PER YEAR AND THAT INCLUDES
413,000 AND THE NOTABLE THING IS
BRINGING THE GENOME SEQUENCE SET
AT 245,000 THE FIRST STRUCTURAL
VARIANT COST AS WELL.
FIT BIT DATA AND THIS JUST SHOWS
THE NEW HIGHLIGHTS WHAT WE
BROUGHT IN FOR RELEASE AND IF
YOU THINK OF THE DIVERSITY OF
THE DATA SET AND GENOME
SEQUENCING ASIDE.
AND TO OBSERVE THE VARIATION IN
A BILLION DIFFERENT LOCATIONS
AND ABOUT 2 THIRDS OF THOSE IF
YOU ARE FAMILIAR WITH THE
RESOURCE ESSENTIALLY THE MOST
COMMON RESOURCE TO SEE A VARIANT
OR NOT MOST OF THESE ARE FIRST
SEEN IN THE DATA SET.
AND 113 MILLION OF COURSE WE
HAVE PHENOTYPE DATA THAT WE
START TO DISENTANGLE THE IMPACT
OF THE GENETIC VARIATION AND
THAT'S 1 OF THE REAL POWERS OF
THE RESOURCE.
HIGHLIGHTING THE EHR DATA IT CAN
GO BACK IN TIME THAT THEY ARE
SHARING RECORDS BACK THROUGH
1980 FIT BIT DATA GOES BACK
THROUGH 2010 BUT THAT IS MORE
THAN 20000 PEOPLE WITH SHARED
PEDIATRIC RECORDS AND ALL THESE
EXTRA THINGS YOU GET WITH THAT
DATA.
WE'VE HAD MULTIPLE DATA TEARS I
ENCOURAGE EVERYONE TO HAVE A
PUBLIC DATA BROWSER WITH NO
LOGIN AND DIAGNOSE THE SURVEY
RESULTS YOU CAN'T DO MUCH CROSS
TABULATION BUT THERE IS A
REGISTERED TEAR AND CONTROL TEAR
WITH DATA ANALYSIS AND THEN THE
STUDIES WE WILL TALK ABOUT OUR
THOUGHTS BUILDING ON THE
RESOURCE THIS IS AN IDEA WHAT
THE DATA BROWSER LOOKS LIKE
GLAUCOMA APPEARS IN THESE
ELEMENTS ACROSS THE DATA SET SO
ALL OF YOUR CLOTHES ARE
AGGREGATED TO GATHER AND THEN
LOOK AT WHAT THOSE VOCABULARIES
LOOK LIGHT SO THE SAME THING.
I'M AN INTERNIST SO ALL OF THE
HYPOGLYCEMIC SO I CAN JUST TYPE
THAT IN AND GET ALL OF THE
STRENGTHS AND GENERICS
TOGETHER.
SO WHEN YOU LOOK AT THE
WORKBENCH YOU HAVE INDIVIDUAL
DATA ANALYSIS.
MEANING TO INDIVIDUAL
RESEARCHERS ONCE APPROVED CAN
CREATE NEW WORKSPACES ON THE
FLY.
AND WITH ALL OF THE DATA THAT IS
AVAILABLE SO ONCE YOU ARE
APPROVED YOU COME IN AND CREATE
YOUR PROJECT ON THE FLY IN THOSE
DESCRIPTIONS ARE MADE PUBLIC.
BECAUSE IT'S IN THE CLOUD WE CAN
AUDIT THAT WE ARE PROTECTING THE
PRIVACY AND SECURITY OF
PARTICIPANTS.
IT IS VERY BROAD BUT WE DON'T
WANT YOU TO STIGMATIZE.
IF IT IS THEN ASK US CURRENTLY
OPEN TO ACADEMIC HEALTHCARE AND
NOT-FOR-PROFIT WE HAVE STARTED
TO TAKE REQUEST INTERNATIONAL AS
WELL.
ONCE YOU COME IN THERE ARE
WEB-BASED TOOL BUT TO DO DATA
ANALYSIS RIGHT NOW WE HAVE 7000
RESEARCHERS 600 INSTITUTIONS WE
HAVE TRIED TO FOCUS ON DIVERSITY
WE HAVE 40 HBCUS USING IT AND
ALSO REACHING OUT TO OTHER
MINORITY INSTITUTIONS AND A
NUMBER OF DIFFERENT PROJECTS THE
PROCESS TO GET ON WITH A FEW
STEPS AND I ENCOURAGE ANYONE BUT
THE INSTITUTION HAS TO HAVE AN
AGREEMENT IF IT SIGNS A MASTER
AGREEMENT WHICH MOST DO THEN
THEY COME TO THE WEBSITE FOR THE
FIRST TIME USUALLY IT IS A
VALIDATION THAT WORKS FOR THE
INSTITUTION AND THEN THEY CAN DO
WORK GOING THROUGH THE TRAINING
MODULES.
THE PAPERS THAT ARE COMING OUT
IT TAKES A FEW YEARS AFTER DATA
RELEASE TO GET MOMENTUM.
THE FIRST PAPER PUBLISHED IS ON
EYE DISEASE AND I WILL SHOW YOU
THAT WITH THE RESEARCH GOING ON
LOOKING AT DIFFERENT CAUSES OR
THE CROSSTAB AND 1 OF THE HIGHER
IMPACT THINGS ON THE TOP LEFT A
LOT OF PEOPLE ARE USING FIT BIT
DATA.
NOT SURPRISINGLY PEOPLE WALK TO
LAST AFTER COVID AND SOME OF
THAT PERSISTED THAN BEFORE COV
COVID.
I GUESS WE CAN ENCOURAGE
OURSELVES TO WALK MORE.
AT THE BOTTOM JUST POINTING OUT
IF YOU LOOK AT THE SURVEY DATA
THAT PARTICIPANTS FILL OUT LOOKS
LIKE A NUMBER OF INDIVIDUALS WHO
HAVE EHR EVIDENCE WHICH MAY
INDICATE THEY MAY NOT KNOW THAT
THEY HAVE IT BUT IT IS A POINT
IN THE KIND OF WORK YOU CAN DO
IN THE PROCESS.
>> THIS IS THE FIRST PAPER TO MY
KNOWLEDGE PUBLISHED BY
INVESTIGATORS USING A RESOURCE.
1 OF THE EYE DISEASE AND THE EHR
AND SHOWS THE POWER TO HAVE
MULTISITE INFORMATION WITH THE
ALGORITHM IS SINGLE SITE THAN
THE PERFORMANCE IS VERY POOR
WHICH IS A RANDOM CHANCE BUT
TRAINED ON MULTISTATE DATA IT IS
VERY GOOD AND WAS SURGERY FOR
GLAUCOMA WITH THE EHR AND IT --
-- AND PUT BASED.
ALSO I WILL TALK ABOUT ANCILLARY
STUDIES BUILDING THE BIG CORE
DATA PEOPLE CAN USE WITH THE EHR
SURVEY BUT THEN ANCILLARY
STUDIES BUILD ON THIS WE WANT
OUR PLATFORM ACROSS NIH WE HAVE
A FEW OF THESE GOING SO FAR WITH
THE SEROLOGY A STUDY WITH NCI
AND A QUANTITATIVE COGNITIVE
BEHAVIORAL TRADE MODELS AND THEN
FOR PRECISION HEALTH 10000
PEOPLE DEEP INVESTIGATION WITH
PARTNERSHIPS OF DIFFERENT
INSTITUTE CENTERS ACROSS NIH
WHICH WILL EVEN DO DOMICILE
FEEDING STUDIES THAT LAUNCHED
MARCH OR APRIL OF THIS YEAR.
SO NOW WE TALK ABOUT WHAT WE CAN
DO AT T12.
JUST 1 OR 2 QUESTIONS NOW?
>> THANK YOU THAT WAS
INTERESTING.
CAN YOU ENLIGHTEN US ON THE
NUTRITIONAL QUESTIONERS I ASSUME
FOR THE LAST PART YOU PRESENTED
THERE IS 25 OR 27 PERCENT OF THE
POPULATION THAT YOU STUDIED IT
SEEMS THEY ARE INDIGENT OR LOW
INCOME AND HOW YOU ARE CAPTURING
THAT ACTIVITY.
>> GREAT QUESTION.
AND PH IS A SUBSET.
IT IS BUILT OFF THE CORRECT
RECRUITMENT SITES AND 1 THAT
LAUNCHED AS PART OF NPH THEY ARE
THE ONLY ONES DEVELOPING A FOOD
QUESTIONNAIRE BUT RIGHT NOW THAT
IS AS THEY DEVELOP AND TEST WITH
A FREQUENCY ALSO USING A COUPLE
DIFFERENT TYPES OF
QUESTIONNAIRES AND THEN THE
SUBSET OF THE COHORT WILL ALSO
THEN FOR WHAT THEY USE AT HOME
WITH DIFFERENT SETS OF
BIOMARKERS AND THEN A SUBSET OF
THAT CLINICAL RESEARCH CENTER
WITH OTHER MEASURES TAKEN DURING
THOSE TIMES AND THERE WILL BE
MORE SURVEYS AS PART OF THOSE
BUT IT WILL BE MULTIMODAL AND
THE GOAL AS WE LOOK AT THE DATA
TO ADOPT SOMETHING LIKE THAT
WITHIN THE LARGER COHORT ALSO
WHAT DID YOU EAT FOR TAKING A
PICTURE OF IT.
WE HOPE THEY ACHIEVE SIMILAR --
-- SIMILAR DIVERSITY.
>> SORRY FOR THE NAÏVE QUESTION
BUT WHAT DOES THAT FORMALLY MEAN
OF UNDERREPRESENT IS THERE A
PRECISE DELTA AND ABSOLUTE
NUMBER OR RELATIVE?
THE POPULATION AT LARGE OR
SOMETHING ELSE?
>> GREAT QUESTION.
FIRST OF ALL WE ARE NOT A
REPRESENTATIVE POPULATION WE ARE
OVERREPRESENTED IN MANY WAYS AND
WE DECIDED WE WOULD GO FOR
REPRESENTATION BUT CAPTURING
DIFFERENCES AND REALLY SEEK TO
OVER AND ROLL THE
UNDERREPRESENTED THE POPULATION
WITH BIOMEDICAL RESEARCH IT IS
THAT MEANING IN SOME CASES A
POPULATION MAY NOT BE
UNDERREPRESENTED AND A GREAT
EXAMPLE WE DON'T KNOW IF THEY
ARE UNDERREPRESENTED BECAUSE A
LOT OF TIMES THE RIGHT QUESTIONS
ARE NOT ASKED THEY MAY BE THERE
OR NOT ESSENTIALLY IT IS THE
SAME THING SO IT'S DIFFERENT AND
THE DIRECTIVE WE ARE NOT
FORMALLY DESIGNED ON THE HEALTH
DISPARITIES IF YOU THINK ABOUT
INCOME AND MANY OF THESE ARE
REPRESENTATIVE DISPARITIES
BEFORE THEY REALIZED IT SO OUR
BASIS IS WHAT COHORTS ARE OUT
THERE AND WHAT IS THE MAKEUP
GENETICS IS A GREAT EXAMPLE.
95 PERCENT ARE OF EUROPEAN
ANCESTRY.
SO WE NEED A LOT OF PEOPLE SO
THAT IS EASY THAT IS OUR
DEFINITION BASED ON WHAT IS OUT
THERE WITH OTHER COHORTS.
THERE IS A PAPER AND I CAN SEND
IT TO YOU IF YOU WOULD LIKE.
>> THANK YOU.
LET'S TRANSITION.
>> THANK YOU FOR HAVING ME.
I AM THE ASSOCIATE DIRECTOR OF
THE NEI DATA SCIENCE AND HEALTH
INFORMATICS COMING UP ON THE
THIRD YEAR ANNIVERSARY WE HAVE
GROWN QUITE A BIT IN TERMS OF
STAFF AND ACTIVITIES COVERING A
VARIETY OF THINGS SO THE OFFICE
COVERS A VARIETY OF ACTIVITIES
FOCUSED ON NOT ONLY DATA
MANAGEMENT AND SHARING BUT
PUBLIC HEALTH, PUBLIC EDUCATION
COMMUNITY BUILDING AND
INCREASING THE OPPORTUNITIES FOR
RESEARCH USE FOR REAL-WORLD
EVIDENCE BUILDING RESOURCES TO
ENSURE TECHNOLOGIES AND VISION
HEALTH.
THEN WE USE THE STRATEGIC PLAN
AS THOUGH WHOLE CHAPTER ON DATA
SCIENCE USING THAT AS A ROADMAP
FOR ACTIVITIES.
BUILDING OFF THE HIGH PROFILE
ADVANCEMENTS IN THE STRATEGIC
PLAN CHAPTER THAT STATES NEI
MUST INVEST IN RESOURCES TO STAY
IN THAT POSITION OF
ADVANCEMENTS.
WE ENGAGED IN THIS PROCESS TO
ADDRESS A SPECIFIC ITEM IN THE
CHAPTER THAT STATES NEI SHOULD
DEVELOP COHORT OF SUBJECT DATA
COUPLED TO CLINICAL VISION
INFORMATION AND GENOMICS AND BIO
SPECIMENS SUCH AS THE BIO BANK
OR THE PROGRAM.
WE ARE ALL AWARE OF THE
ADVANCEMENTS IN OCULAR IMAGING A
COMMON PART OF MODERN EYE CARE
AND THAT DATA ANALYSIS AND
TECHNOLOGY HAS ADVANCED TO ALLOW
ARTIFICIAL INTELLIGENCE AND DEEP
LEARNING METHODS TO BE APPLIED
FOR RESEARCH AND DEVELOPMENT
CLINICAL SUPPORT AND LAY THE
GROUNDWORK IN A NEW AREA OF
SCIENCE THE OFFICE HAVE BEEN
INVOLVED IN COMMUNITY BUILDING
AROUND OCULAR IMAGING AIM TO
INCREASE IMAGING STANDARDS AND
TO RECOGNIZE WE ARE AT A PLACE
AND TIME WHERE THERE WAS THE
ABILITY TO COMBINE THE ANALYSIS
OF RETINAL IMAGES WITH
BIOMEDICAL DATA INFORMATION TO
ENABLE A BROAD SCOPE OF RESEARCH
APPLICATIONS I WILL GO INTO
THESE FURTHER A LITTLE BIT WHEN
I DISCUSS THE OUTCOMES OF THE
WORKSHOP BUT JUST TO SAY THESE
CAN INCLUDE THINGS LIKE RISK
FACTORS VERSUS SYSTEMIC DISEASE
AND BIOMEDICAL CAUSES IN THE
DEVELOPMENT OF TOOLS FOR
IMPROVING EYE DISEASE PREVENTION
AND TREATMENT AND HOWEVER TO
DATE RESEARCH IS LARGELY LIMITED
WITH THE LACK OF PUBLICLY
AVAILABLE AGNOSTIC COHORTS IT IS
A SITUATION INCONSISTENTLY
APPLIED WITH DATA STANDARDS AND
THEN TO EXTRACT THOSE STANDARDS
IN THE TRANSPARENT WAY.
DATA QUALITY ISSUES AND GAPS
LINK TO CLINICAL DATA.
SO WE HELD A WORKSHOP APRIL 23
THIS IS IN COLLABORATION WITH
THE NATIONAL INSTITUTE
BIOMEDICAL IMAGING AND
BIOMEDICAL ENGINEERING AND ALL
THE RESEARCH PROGRAM WHICH JOSH
JUST HIGHLIGHTED.
WE HOSTED THE WORKSHOP TO GET
SPECIFIC INSIGHT FROM EXPERTS IN
THE FIELD TO MAKE SURE MAXIMUM
ENGAGEMENT TO CAPTURE THAT
GRANULAR DETAIL TO MAKE THIS A
SUCCESSFUL PROJECT TO BE HOLD IN
A CLOSED MANNER OF 60 FOLKS AND
WITH OPHTHALMOLOGY AND
DIAGNOSTICS AND THE PLATFORMS
PUBLIC HEALTH.
BIOMARKERS PRIVACY A DATA
SECURITY HEALTH DISPARITIES AND
DURING THE MEETING WE EXPLORED
THE CURRENT STATE OF SCIENCE AND
THEN WE TALK ABOUT DATA
ANALYTICS TOOLS NEEDED TO
ADVANCE THE FIELD AND THEN TO
HIGHLIGHT AGAIN AND TO HAVE
EXTENSIVE EXPERIENCE IN THE
FIRST PAPER FROM ALL OF US
RESEARCH PROGRAM SHE ANALYZED
HEALTH RECORDS AND PRIMARY
OPENING OF GLAUCOMA.
AND THE AI MODEL TO PREDICT THE
NEED FOR SURGERY AND FOUND THAT
THROUGH USING THOSE MODELS IT
WAS MORE EFFICIENT AND
PREDICTIVE THAN A SINGLE SOURCE
DATA SET IT WAS A PROOF OF
PRINCIPLE THAT IT COULD BE A
SIGNIFICANT RESOURCE FOR THE
VISION COMMUNITY.
AND OUR THINKING WAS AND THEN TO
HAVE A GREAT OPPORTUNITY AND
THEN TO MOVE FORWARD WITH
DISCUSSIONS HOW TO INCORPORATE.
AND THEN WITH VARYING OPINIONS
IN THERE WITH THAT OCULAR
IMAGING TO A SUBSET OF ALL
PARTICIPANTS AND THEN WITH THE
RECENT EXPLOSION OF AI AND
COMPUTER SCIENCE TECHNIQUES AND
THEN WE WILL TALK MORE.
AND THEN WITH THAT CONSENSUS AND
STANDARDIZATION WITH THE
CLINICAL RECORDS.
AND THEN USING THE SAME DATA
MODEL.
AND SO THAT WORK PLUS THE OCULAR
IMAGING WOULD BUILD A TOOL THAT
WE CAN USE MORE TO UNDERSTAND
OUTCOMES.
AND THEN TO POST WORKSHOP
SUMMARIES.
AND THE SUMMARY OF THE
DISCUSSIONS THERE IS A QR CODE
SINCE LAST WEEK AND WITH
DOWNLOADS AS OF YESTERDAY ANYONE
THAT IS INTERESTED WITH OCULAR
IMAGING AND RESEARCH.
AND I JUST WANT TO TAKE A MINUTE
WHILE PEOPLE ARE SCANNING TO
GIVE SPECIAL THANKS TO THE
PEOPLE WHO ORGANIZE THE
WORKSHOP.
THANK YOU FROM ALL OF US.
WE CANNOT HAVE DONE ANY OF THIS
WITHOUT THEM.
AND THEN THE CHIEF MEDICAL
SCIENTIFIC OFFICER SAYING THE
WORKSHOP OPERATE AT THE
INTERSECTION OF CLINICAL
THERAPEUTICS OCULAR DATA
POPULATION HEALTH SCIENCE.
AND WE DID TALK ABOUT RESEARCH
USE CASES.
AND THEN TO ADD THAT OCULAR
IMAGING AND SPECIFICALLY WE
TALKED ABOUT ADDING RETINAL
PHOTOS TO THE DATA SET.
AS DR. CHANG SAID THE WINDOW OF
THE SOUL AND OVERALL HEALTH SO
HIGH QUALITY IMAGING.
SO IF THAT COULD BE IN A
COST-EFFECTIVE WAY AND WITH
BIOMETRIC DATA AND GENOMIC DATA
FROM A VERY LARGE DIVERSE
DISEASE.
WITH DEGENERATIVE HEALTH AND
VASCULAR AGING.
AND THEN WITH AN EQUITY OF
HEALTH SERVICES AND RESOURCES.
SO BEING INFORMED BY THAT
WORKSHOP EXPERTS WE TOOK THAT
ESSENTIAL COMMUNITY INPUT AND
BEGAN WORKING ON PUTTING
TOGETHER AN ANCILLARY STUDY
PROPOSAL TO INTRODUCE OCULAR
IMAGING AND ANOTHER DATA TYPE
FOR RESEARCHERS.
AND LOOKING AT A PILOT STUDY
WITH THE 2 INSTRUMENTS.
HIGH QUALITY LOW COST EASY TO
USE DEVICES FOR THE EXISTING ALL
OF US LOCATIONS.
FROM THESE DEVICES TO EXTRACT
TABULAR DATA IN ADDITION TO THE
IMAGE FILE FORMATS AND THEN I
CAN BE FILTERED AND SORTED AND
JOINED WITH OTHER EXISTING DATA
SETS.
AND THEN TO LINK TO THOSE
DATATYPES AND THAT ADDITIONAL
DATA WE HOPE WILL LEAD TO A
SUFFICIENT COHORT OF HIGH
QUALITY IMAGES FROM DIVERSE
BACKGROUNDS WITH A SCIENTIFIC
HYPOTHESIS DRIVEN STUDIES THAT
WE ALLUDED TO.
NOT ONLY IN OCULAR HEALTH BUT
SYSTEMIC CONDITIONS.
SO THE 4 SITES HAVE YET TO BE
DETERMINED IT IS A PROPOSAL AT
THIS POINT AND HAS NOT GONE TO
EXECUTION.
SO A HUGE PART OF THE PROPOSAL
IS WHAT IS THE BENEFIT TO
PARTICIPANTS PRIDING THEMSELVES
OF PARTICIPANT ENGAGEMENT TO
MAKE SURE THAT WE ARE
RECOGNIZING THE VALUABLE
CONTRIBUTION AND THEIR VALUABLE
TIME SO OUR PROPOSAL IS TO
EVALUATE REFERRAL NEEDS AND
BUILD THAT OFF OF WHAT WE
LEARNED FROM THE PILOT PHASE.
LOOKING AT THE PILOT OF 500
PARTICIPANTS AND THEN THE IMAGES
TO SEE IF THERE IS ANY
DIFFERENCES IN THE LOCATIONS TO
OPTIMIZE THE PROTOCOL FOR
ACQUISITION TO MAKE SURE THOSE
AT DIFFERENT SITES ARE
COMPARABLE AND THERE'S NO SUBTLE
DIFFERENCES OR BIASES BASED ON
THE LOCATIONS WE SELECT.
WE HOPE AFTER THIS WE EXPAND
THIS.
JUST TO WRAP UP WITH THE
ANCILLARY STUDY PROCESS WE
SUBMITTED THE PROPOSAL OF THE
PILOT TO THE ALL OF US PROGRAM
JUST A FEW WEEKS BACK.
AS OF 2 DAYS AGO THAT IS TO THE
ALL OF US DIVISION AND WORKING
ON SCHEDULING A TIME FOR MORE
FEEDBACK FROM ALL OF US AND THE
BRAIN TRUST BEFORE IT IS
SUBMITTED FOR FINAL LEADERSHIP
APPROVAL AND THEN WE BEGIN TO
LAUNCH THE PROJECT SO WITH THAT
I WILL TAKE QUESTIONS AND I'M
INTERESTED IN THOUGHTS.
>> THANK YOU.
>> THANK YOU THAT WAS
INFORMATIVE.
YOU PROBABLY SET IT AND I MISSED
IT BUT WILL THE BLOOD SAMPLES BE
AVAILABLE TO INVESTIGATORS LIKE
WHERE YOU GO AND ASK FOR ACCESS
TO YOU HAVE AN IDEA?
IS THAT SOMETHING IN THE
VISION?
>> THIS WILL BECOME A PART OF
THE ALL OF US RESEARCH PROJECT
SO TO HAVE ACCESS THEY HAVE TO
HAVE THE RIGHT PERMISSION LEVELS
AND FEEL FREE TO INTERRUPT ME A
LINK THE DATA TO BIO SAMPLES.
>> WERE STUDYING -- -- STARTING
WITH PARTNERSHIPS AND EVENTUALLY
MOVING TO INDIVIDUAL RESEARCHERS
AND THAT IS SOMETIME IN THE
FUTURE WITH THESE KINDS OF
PROJECTS WITH A SET OF
BIOMARKERS THEY WANT TO LOOK FOR
AND THEN FEED THAT BACK TO WEST
AND IN THE PROCESS STARTING WITH
THE LARGE SCALE ONES AS WE BUILD
OUT THAT CAPABILITY.
>> THIS IS AN INCREDIBLE
RESOURCE.
SO NOW WITH AN ADVERTISING
CAMPAIGN THAT MANY PEOPLE IN THE
SCIENTIFIC COMMUNITY.
>> THAT'S AN IMPORTANT POINT WE
ARE SURE TO SPREAD THE WORD WELL
WE ARE HERE AND TALKING TO YOU
TO BOLSTER THAT AS WELL.
ALL OF US DOES A LOT OF
COMMUNICATING WITH THE PUBLIC.
WE ALSO HAVE THE NEI WEBSITE AND
COMMENTS I'M PRETTY SURE WE WILL
HIGHLIGHT A LOT OF THIS WORK
TOWARD THE ALL OF US PROJECT.
[INAUDIBLE]
>> THANK YOU FOR SHARING.
TO QUESTIONS.
ANY PLANS ARE YOU WORRIED YOU
TRY TO COLLECT TOO MANY TESTS AT
THERE'S NOT EVEN CONSENSUS?
AND DON'T KNOW WHAT TO DO WITH
IT?
>> I SHOULD HAVE KEYED IN ON
THAT.
SO IN OUR PROPOSAL THERE IS NO
INTERPRETATION NECESSARILY AT
THE STAGE WE WERE JUST
COLLECTING DATA SO RESEARCH
WOULD -- -- RESEARCHERS WOULD
HAVE ACCESS.
BUT AFTER WE LOOK AT THIS IS
THERE A WAY TO BUILD IN THE
REVIEW AND NOT INTERPRETATION TO
RECOGNIZE IT IS JUST FOR
RESEARCH USE AND IT IS NOT FDA
APPROVED.
CLEARLY FOR RESEARCH.
>> LET'S TAKE 1 MORE QUESTION.
PLEASE SAVE OTHER COMMENTS.
>> ARE THERE OTHER MEASURES THAT
ARE MADE DURING THE ASSESSMENT
ITSELF OR IS EVERYTHING EYE
RELATED OTHER THAN THE IMAGING
YOU ARE PROPOSING COMING FROM
MEDICAL RECORDS?
>> GOOD QUESTION WE ARE HOPING
TO CAPTURE STANDARDS OVER VISUAL
ACUITY AND WORK WITHIN THE
WORKFLOW OF THE EXISTING SITES
AND IT WOULD STILL HAVE AN
IMPACT MAY BE A DARKENED ROOM.
SO THOSE PIECES WOULD BE WORKED
OUT IN THE FURTHER ELEMENTS TO
FIGURE OUT HOW THIS FITS INTO
THE WORKFLOW SO PRIORITIZING
VISUAL ACUITY AND INTRAOCULAR
PRESSURE SO THOSE ARE PARTS OF
THIS PROJECT AS WELL.
WE DID THIS EVEN BEFORE THE
ANCILLARY STUDY PROCESS TO SEE
WHAT TYPE OF EYE MEASURES ARE
THERE IT IS PRETTY SPARSE WE ARE
HOPING IT IS A TWO-PRONGED
APPROACH.
>> SO IT SEEMS LIKE REFRACTIVE
ERROR IS ONCE EVERY 20 YEARS AND
WITH COUNTRIES LIKE CHINA AND
THE ASSESSMENTS THAT THEY HAVE
IN THE SURVEILLANCE THAT THEY
HAVE THE EFFECTS OF COVID AND
THE PREVALENCE OF CHANGING IN
THE ENVIRONMENT ARE BECOMING
VERY AWARE OF THE NATIONAL
ACADEMIES HOW SPARSE THE DATA
SETS ARE THAT WOULD BE A GOOD
ADJUNCT IN THAT IT OCCURS TO ME
THAT ARTIFICIAL INTELLIGENCE
MAKES A PRETTY GOOD ASSESSMENT
FROM THIS PHOTO AND THIS IS A
HIGH TECH WAY TO GET THAT
REFRACTIVE ERROR AND THERE ARE
WAYS THAT ARE SMART PHONE BASE
TO BE MORE WIDELY IMPLEMENTED.
>> LEADING UP REALLY WELL WE ARE
DOING OTHER THINGS TO GET MORE
OF THAT SURVEILLANCE INFORMATION
AND REAL-WORLD DATA.
>> THANK YOU VERY MUCH.
1 OF THE REASONS WE ARE
TRANSITIONING IS THE INCREDIBLE
RESOURCE FOR THE COMMUNITY AT
LARGE TO STUDY AND ANSWER SOME
OF THESE QUESTIONS AND WHAT THEY
LOOK LIKE.
AND IT FEELS LIKE APPLES AND
ORANGES AND WHAT CAN WE DO TO
MAKE IT APPLES TO APPLES?
>> THANK YOU FOR THE OPPORTUNITY
TO TALK ABOUT THE DATA MODELS
WHICH IS JUST ANOTHER WAY TO
STANDARDIZE THE DATA.
I AM THE FIRST DATA SCHOLAR AND
I THOUGHT I WOULD EXPLAIN MORE
WITH THE DATA SCHOLARS PROGRAM
IS.
STARTED BY THE STRATEGY IN 2020
AND TO PROMOTE THE WORKFORCE THE
BIOMEDICAL WORKFORCE SKILLED IN
DATA SCIENCE AND EACH INSTITUTE
OR CENTER CAN HAVE 1 NEW DATA
SCHOLAR PER YEAR AND EACH CAN
STAY BETWEEN 1 AND 2 YEARS
WORKING ON A PROJECT WITHIN THE
INSTITUTE AND THEY PARTICIPATE
IN THE NIH WORK GROUPS.
SO I'M TALKING ABOUT THE WORK I
HAVE BEEN DOING AS PART OF MY
PROJECT.
I AM JUST STARTING MY SECOND
YEAR.
BEFORE THIS AND AFTER THIS IS IN
OREGON WORKING IN
OPHTHALMOLOGY.
WE ALL KNOW WE HAVE BEEN HEARING
ABOUT THE IMPORTANCE OF LARGE
DIVERSE DATA SETS IF THAT IS IN
THE DATA GENERATION PROJECT OR
RETROSPECTIVE DATA WE ALREADY
COLLECTED, IT'S IMPORTANT THAT
WHATEVER WE USE REFLECTS
DIVERSITY OF THE PATIENTS BUT
ALSO OF PRACTICE PATTERNS ALL OF
THE DIFFERENT DATA TYPES
AVAILABLE AND THIS GIVES US A
SET FOR RESEARCH AND IMPORTANTLY
AND HOPEFULLY MINIMIZES THE BIAS
THAT MAY RESULT OF THE DATA SET
AND 1 OF THE KEYS TO THIS
DIVERSITY IS TO HAVE DATA COMING
IN FROM MULTIPLE LOCATIONS
ACROSS THE COUNTRY AND EVEN THE
WORLD.
BUT WITH RESPECT TO DATA
ORIGINATING WITH THE DHR IT IS
SIDELOAD.
NOT EVEN GOOD ENOUGH TO HAVE THE
SAME DHR DIFFERENT LOCATIONS TO
SPEAK TOGETHER BECAUSE THERE ARE
DIFFERENCES OF HOW THEY ARE
IMPLEMENTED.
WE NEED SOME DATA
STANDARDIZATION WHICH ANY OF YOU
HAVE DONE MULTI- SCIENCE STUDIES
KNOW THAT CAN TAKE QUITE A BIT
OF TIME.
IN TERMS OF BUILDING THE LARGE
DATA SETS WE HAVE 2 WAYS OF
DOING IT AND EACH HAS ADVANTAGES
AND DISADVANTAGES.
THE FIRST APPROACHES TO POOL
DATA AND THAT IS THE CLASSIC
MODEL WHERE THEY ARE
PROSPECTIVELY COLLECTING DATA OR
RETROSPECTIVE DATA TOGETHER AND
WE ARE FAMILIAR WITH THE
DIFFERENT EXAMPLES A RARE
DISEASE REGISTRY DATA SET
GENERATION PROJECTS AND IT HAS A
LOT OF STRINGS PULLING IN THE
LARGE AGGREGATED DATA.
SO FOR EXAMPLE IF YOU WANT
ACCESS TO ALL OF THIS DATA YOU
CAN DO ALL OF THE APPROVAL
PROCESS TO GET IT AND YOU
CONSIDER THE WORKBENCH AND DO
THE ANALYSIS YOURSELF.
THERE ARE SOME DISADVANTAGES
THAT IT CAN REQUIRE EXTENSIVE
LEGAL PRIVACY AND SECURITY
AGREEMENTS.
ESPECIALLY FOR CONTRIBUTING DATA
THROUGH REGISTRIES.
FOR THE IRISH REGISTRY AND FROM
MY OWN PERSPECTIVE IT TOOK YEARS
FOR US TO GO THROUGH ALL OF
THOSE HURDLES TO FREE UP THE
DATA.
AND LIKE ANY OTHER PROJECT
REQUIRES EFFORT AND WITH THAT
SCALABILITY AND IT TAKE SO MUCH
WORK TO GET EACH SITE
CONTRIBUTING AND ONCE YOU START
LOOKING AT THE STRUGGLES AND TO
GET COPIES OF THE DATA SET SOME
WAYS THAT'S JUST IMPOSSIBLE.
SO THE SECOND APPROACH IS
SOMEWHAT NEWER AND THE IDEA IS
EACH SITE KEEPS THEIR OWN DATA
AND MAYBE THINK HOW ON EARTH
DOES THIS WORK?
WHAT RESEARCHERS DO THERE IS A
LOT OF WORK AND TOOLS THAT ARE
BUILT TO ALLOW RESEARCHERS TO
SHARE THEIR COLD AND MODELS SO
THOSE ARE RUN AT EACH INDIVIDUAL
SITE SO THERE ARE SOME EXAMPLES
OF THIS TALK ABOUT THE
OBSERVATIONAL DATA HOW -- --
DATA HEALTH SCIENCES AND THEIR
OTHER NETWORKS OUT THERE.
IT IS MUCH MORE SCALABLE AND
BECAUSE YOU DON'T SEND DATA
AROUND YOU CAN KEEP THE IMAGING
IN YOUR OWN LOCATION.
THAT ALSO HELPS TO MAKE MORE
DATA AVAILABLE.
IF YOU REALLY WANT TO HAVE
SYSTEMIC DATA WE DON'T HAVE TO
WORRY ABOUT TRYING TO PULL IT
ALL OUT AND SEND IT BUT WE CAN
JUST ACCESS IT.
ALSO AVOIDS THE DATA SHARING
AGREEMENTS THAT OTHERS REQUIRE.
OF COURSE IT REQUIRES A LOT OF
WORK.
'S AND NOT THE HARMONIZATION BUT
IF YOU RUN A STUDY YOU HAVE TO
HAVE PARTNERS SO IF YOU DO STEP
IN AND HELP RUN THOSE MODELS FOR
YOU.
HOWEVER WE ARE CONSIDERING TOOLS
THAT MAY HELP TO FACILITATE
THAT.
SO REGARDLESS OF YOUR APPROACH
CONTRIBUTING TO LARGE DATA SET
REQUIRES HAVING DATA
STANDARDIZATION SO TO USE A
COMMON DATA MODEL I AM TALKING
ABOUT OMOP THIS IS WHAT WE HAVE
BEEN TRYING TO BE THE DATA A
PART OF BECAUSE OFFICIALLY IT IS
NOT SO THAT ACRONYM REFERS TO A
PARTNERSHIP.
AND THEN TO WITH THE EFFECTS
BETWEEN THE FDA AND ACADEMIA.
MUNSON TO USE OBSERVATIONAL
HEALTH DATA TO DO MEDICAL
SURVEILLANCE AND WITH CLAIMS
DATA TO GET THAT STANDARDIZED.
THE LEGACY OF THE PROJECT IS THE
OMOP DATA MODEL IS JUST A
STANDARDIZED DATA SCALE OR HOW
YOU ORGANIZE YOUR DATA ALONG
WITH THE CONVENTIONS OF HOW THE
DATA GETS PUT INTO THE
DATABASE.
AND THIS OMOP MODEL THAT HAS
BECOME POPULAR WITH THE
INFRASTRUCTURE INVOLVED WITH A
LOT OF PROJECTS.
AND THEN TO THROW ANOTHER
ACRONYM IS IT IS OHDSI THAT IS
COMMITTED TO IMPROVING HEALTH BY
MAKING ALL OF THE HEALTH DATA
AVAILABLE THROUGH OMOP.
I KEEP HEARING THESE AMAZING
STATISTICS.
30 PERCENT OF ALL THE DATA THAT
IS AVAILABLE AND IT IS GROWING.
THAT IS WHAT THIS COMMUNITY IS
FOCUSED ON.
SO FOCUSING OVER THE LAST YEARS
TO BUILD A RICH SET OF TOOLS FOR
HOW YOU APPROPRIATELY USE THE
DATA IS NOT JUST ENOUGH TO SAY
BUT HOW DO WE DO THIS IN A WAY
TO STANDARDIZE THE USE TO
PRODUCE REPRODUCIBLE RESEARCH
AND SUPPORTING THOUSANDS OF
STUDIES THOUSANDS OF
COLLABORATIVES ACROSS THE WORLD
RESEARCHERS RE- -- -- USING THE
DATA.
AS AN EXAMPLE OF A PILOT STUDY
AND DID VERY RECENTLY USING THE
OHDSI NETWORK WITH THE RESEARCH
QUESTION WITH THE RISK
ASSOCIATED WITH INJECTIONS FOR
PATIENTS OF LYME DISEASE.
AND KNOWING BECAUSE 1 HAS A MUCH
SHORTER HALF-LIFE THAN A LOT OF
TIMES IT WAS 20 TIMES MORE
EXPENSIVE THAN THE OTHER AGENTS
BECAUSE THEY REALLY WANT TO
PROTECT THEIR PATIENTS SO THAT
HYPOTHESIS WAS WHEN SHE WAS
EXPECTING THE COMPARISONS TO
TAKE THESE 3 DIFFERENT AGENTS
THAT YOU WOULD SEE A LOWER RISK
OF KIDNEY FAILURE SO SHE DID
THIS STUDY OVER THE COURSE OF 9
WEEKS WITH 12 DIFFERENT DATA
SITES WHICH REPRESENTED
485 MILLION PATIENTS SO THIS IS
AN AMAZING AMOUNT OF PATIENCE
REPRESENTED IN 6.1 MILLION HAVE
BLINDING DISEASES AND THEN THEY
HAVE KIDNEY FAILURE OUTCOMES.
AND THERE IS A LITTLE BIT
INCREASE PROPORTION IN THIS
POPULATION OF KIDNEY FAILURE FOR
THESE PATIENTS HOWEVER WHEN SHE
LOOKED AT THE COMPARISON OF
THESE 3 DIFFERENT AGENTS THE
HAZARD RATIO WAS AROUND 1.0 SO
STILL TRYING TO FIGURE OUT BUT
IT DEMONSTRATES THE SPEED AND
SCALE OF CLINICAL RESEARCH
AVAILABLE THROUGH USING THE
POWER OF THE NETWORK DATA SETS.
THIS IS HOW I VISUALIZE IT
THROUGH OMOP FOCUSING ON THE
DATA AVAILABLE IN CLAIMS DATA
LIKE DIAGNOSIS
CODES, PRESCRIPTIONS.
AND THEN EXPANDED BEYOND THAT SO
THE HR DATA CAN BE AVAILABLE.
VITALS AND LABS INPATIENT
STAYS.
AND DATA RELATED TO WHAT YOU
ENTER INTO SO IT IS NOT
REPRESENTED WELL IN THE DATA SET
SO WE ARE LOOKING AT ADDING THAT
DATA THEN TO HAVE ANOTHER LAYER
THAT INTEGRATES AND EACH TIME
YOU EXPAND THE DATA AVAILABLE WE
ENABLE MUCH MORE DIVERSE
RESEARCH.
SO WITH THE DATA IMAGING.
AND ALLOWED A - - A LOT OF THAT
IS ENTERED AND THERE WAS A LOT
OF VARIABILITY OF HOW THIS IS
ENTERED IN SOME PREFER TO ENTER
ALL THE DATA AND THEN IMAGING
HAS ITS OWN STANDARD AND A LOT
OF THE SCANS ARE LARGE AND
DIFFICULT.
AND TO HEAR THAT APPROACH FROM
FEDERATED LEARNING AND WHAT YOU
ARE TRADING BETWEEN THE SITES
INSTEAD OF DATA WITH THE
INTERMEDIATE RESULTS TO UPDATE
THE MODELING KEEP GOING.
SO THE GROUP DOING ALL OF THE
WORK IS THE EYE CARE AND VISION
RESEARCH WORKGROUP AND A MULTI-
GROUP OF RESEARCHERS OF EYE
VISION RESEARCH WE OFFICIALLY
HAVE 120 MEMBERS.
40 OF THEM ARE ACTIVE AND THEY
REPRESENT MAJORITY OF CLINICIAN
SCIENTIST.
AND SO WORKING HARD WITH THAT
IMAGING.
AND FIGURING OUT WAYS TO
STANDARDIZE HOW THE DATA IS
USED.
SO WHAT ARE THE RULES AND THE
DIAGNOSIS?
AND USING ANY TYPE OF DATA TO
SPECIFY IF THEY HAVE THIS
DISEASE.
AND GETTING HIGH QUALITY IMAGING
INTO ALL OF US BUT ALSO TO BUILD
AND BECOME OF THE PARTISAN
NETWORK SO INITIALLY TO BUILD A
SMALL CORE OF DATA AND THE DREAM
COULD BE THE END TIRE OHDSI
NETWORK AND THAT WILL TAKE A
WHILE TO GET THERE SO DEVELOP A
SMALL GROUP TO HAVE THE DATA AND
IMAGING IN THEIR SITE THAT
COORDINATING CENTER WITH THE
RIGHT FORMAT AND THEN FACILITATE
THE STUDIES THAT IS THEM WITH
THE DATA.
AND WITH THAT ABILITY TO EXTEND
CLINICAL TRIALS.
SO THEY ARE TIME LIMITED AND THE
PATIENT'S STUDIED ARE NOT QUITE
AS BROAD AS THE ONES WE ARE
TREATING.
SO TO LOOK AT YEARS DOWN THE
LINE AND WHAT ARE THE OUTCOMES
OF THE PATIENT'S SO WE CAN LOOK
AT WHAT IS HAPPENING IN THE
COMMUNITY AND LOOKING AT THOSE
OUTCOMES AND ANOTHER VALUABLE
RESOURCE IS FOR VALIDATION THERE
IS A LOT OF RESEARCH AND
EXCITING THINGS BEING DONE BUT
VERY FEW OF THOSE MODELS SO
HAVING DATA AVAILABLE WOULD BE
POWERFUL FOR RESEARCHERS TO MOVE
THE FIELD ALONG.
AS I MENTIONED REAL-WORLD
OUTCOMES AS WELL AS DISEASE
STUDIES AND HAVING A LOT OF DATA
TO EXPAND THE NETWORK ENOUGH TO
STUDY HEALTHCARE ACCESS.
THE IMPACT IS PRETTY GREAT
HAVING THIS AVAILABLE TO DO MORE
STUDIES BEYOND CLINICAL TRIALS.
AND IMPROVING THE BIAS OF DATA
SETS.
BUT WHAT IS INTERESTING ABOUT
THIS IS IT IS A UNIQUE WAY TO
SUPPORT DATA SHARING.
YOU ARE GETTING THE GROUP TO
STANDARDIZE THE DATA UP FRONT.
SO AS THE INDIVIDUAL RESEARC
RESEARCHER, USING THE DATA YOU
NO LONGER HAVE THE BURDEN TO
FIGURE OUT HOW TO GET THE DATA
INTO THE FRAMEWORK OR WHERE DO I
PUT IT ALL YOU NEED TO WORRY
ABOUT IS THE PHENOTYPES.
WITH AN ENTIRELY DIFFERENT TALK
IS IMPROVING THE STANDARDIZATION
THAT REALLY HELPS CLINICAL CARE
AND MEASUREMENT.
SO IN SUMMARY WE NEED THESE
LARGE DATA SETS AND WE ARE
REALLY WORKING HARD IMPROVING
THE DATA AND IMAGING TO BE PART
OF PROJECTS FROM THE LARGE DATA
NETWORKS.
AND IT HELPS TO FACILITATE DATA
SHARING AND RESEARCH.
IF YOU HAVE QUESTIONS I WOULD
LOVE TO TRY TO ANSWER THEM FOR
YOU.
>> THANK YOU.
>> LET'S TAKE QUESTION
SPECIFICALLY FOR MICHELLE THEN
WE WILL OPEN UP.
>> THAT WAS NICE THEY CAN YOU
COMMENT HOW THE IRIS REGISTRY.
[INAUDIBLE]
>> GOOD QUESTION WE HAVE BEEN
TALKING WITH THEM AND WHAT WOULD
BE WONDERFUL IS IF THEY COULD
ACTUALLY IF THEY WERE
STANDARDIZE THE SAME WAY FROM
WHAT THEY ARE COLLECTING FROM
THE REGISTRY IS DIFFERENT FROM
THE OTHER DATA SETS WITH MAINLY
ACADEMIC MEDICAL CENTERS.
WE HAVE BEEN TALKING WITH
SEVERAL PEOPLE TO SEE HOW WE CAN
GET THAT TO BE A PART OF THIS.
>> VERY NICE AND VERY IMPORTANT
THIS WORK WILL HAVE TO BE
LONG-TERM AND THAT IS THE
CHALLENGE WHICH IS NOT THE
TYPICAL MODEL FOR ACADEMIC
RESEARCHERS AND ALSO FOR
INDUSTRY WHERE WE TRY TO
MONETIZE ACCESS TO DATA.
SO GIVEN ALL THAT IS THERE A
CENTRALIZED SUPERSTRUCTURE?
OR IS THIS ALL DONE IN DIFFERENT
WAYS BY DIFFERENT PEOPLE?
>> IT SUCH AN IMPORTANT QUESTION
AND THE ANSWER TO THAT IS ABOVE
MY PAY GRADE AS A DATA SCHOLAR.
LOVE TO SEE MORE RESOURCES FOR
THIS BUT I WOULD POINT TO A
WONDERFUL EXAMPLE OF THE
COMMUNITY ALREADY IN EXISTENCE
OVER A DECADE.
THEY HAVE LEVERAGED PARTNERSHIPS
AWAY SIGNIFICANT NUMBER OF THE
PEOPLE PUSHING THIS AHEAD.
SO THERE ARE SOME MODELS THAT WE
CAN FOLLOW AND IT GIVES ME HOPE
THAT WE ARE NOT STARTING FROM
SCRATCH BUILDING OFF OF THE
EXISTING THING.
I HOPE WE CAN MAKE THIS
SUSTAINABLE SO THAT IS ALL OF
OUR CONCERN AS WELL.
>> I HAVE BEEN INVOLVED IN THE
OHDSI COMMUNITY FOR MANY YEARS.
IT'S A LITTLE CHALLENGING PLACE
FOR NEI BECAUSE WE DON'T HAVE
THE DATA SET THAT WE CAN
CONTRIBUTE TO - - CONTRIBUTE.
BUT IT GOES TO SHOW WE CAN GIVE
A POSITION TO CONTINUE HER
THROUGH THE OFFICE THAT IS A
CORE AREA OF ACTIVITY SO EVEN
WHEN MICHELLE IS GONE WE WILL
FIGURE OUT WAYS TO SUPPORT THE
EFFORT.
THE ODYSSEY COMMUNITY IS AMAZING
AND THE WHOLE COMMUNITY
STRUGGLES.
BUT WE ARE BUILDING ON THE
SHOULDERS OF GIANTS AND WE WILL
CONTINUE TO KEEP THIS GOING.
>> MARIA GRANT.
FANTASTIC PRESENTATION.
THANK YOU.
THE MORE INFORMATION YOU HAVE
THE MORE MISINFORMATION YOU CAN
HAVE ESPECIALLY THE DIABETIC
MACULAR CODE BUT IT HAS REMAINED
THE SAME THAT THE PATIENT
RESOLVES AND GETS BETTER SOMEONE
WOULD LOVE TO USE THIS AS A
RESOURCE SO HOW DO YOU VALIDATE
THAT BUILDING CODE WITH A
CLINICAL EXAM?
IT'S NOT DATA THAT I WANT.
I WANT TO PATIENT SAMPLE THAT IS
RELIABLE.
I KNOW YOU UNDERSTAND THAT BUT
HOW WILL YOU ADDRESS THAT?
BECAUSE IT TAKES A LONG TIME.
SO WHO WAS DOING THAT KIND OF
WORK?
>> ME.
THERE ARE A FAIR NUMBER OF US
DOING THAT WORK.
EXACTLY YOU CANNOT RELY ON
BILLING CODES ALONE.
BECAUSE THEY ARE NOT ACCURATE.
SOMETIMES MISSING, NOT
OVERTIME.
OR CHOOSE DATA AND SOMETIMES
THOSE CODES ARE MISSING.
IS NOT NEEDED FOR
REIMBURSEMENT.
OUR ANSWER IS USING PROGRESS
NOTES AND IF WE CAN ADD MORE
ELEMENTS TO GET METADATA FROM
THE IMAGING WE WILL USE AS MUCH
AS WE CAN TO BUILD THESE
DIFFERENT PHENOTYPES SO WE DON'T
RELY JUST ON BILLING CODES.
BECAUSE IN A LOT OF CASES THEY
ARE NOT ACCURATE.
>> A GREAT EFFORT FROM JOHNS
HOPKINS.
OF HOW INDIVIDUAL INSTITUTIONAL
HANDLE THIS IN THE HETEROGEN
HETEROGENEITY?
I SUSPECT THERE IS A LOT OF
DIFFERENCES AND HOW PEOPLE WANT
DATA SHARED IN THE PERMISSION
THEY HAVE TO GIVE.
AND HOW THEY HANDLE DIFFERENT
TYPES OF DATA WHICH SOME
INSTITUTIONS CONSIDER TO BE
PRIVATE.
AND HAVE NETWORKS TO ACCESS
THAT.
BUT ARE YOU SEEING HETEROGEN
HETEROGENEITY?
IN OUR THOSE STANDARDS COMING
OUT SO OF DIFFERENT INSTITUTIONS
HANDLE THIS THE SAME WAY TO GET
DIFFERENT RESPONSES FROM
DIFFERENT PLACES?
>> SO FOR THAT STUDY, SOME OF
THE DATA SITES THAT WERE A PART
OF THAT WERE RELATIVELY NEW TO
THE OHDSI STUDY.
THERE WERE PROPOSALS THAT HAD TO
BE AMENDED AND APPROVED.
I HONESTLY DON'T KNOW THE
PROCESS TO GETTING INSTITUTIONS
TO CONVERGE ON 1 WAY TO DO IT
BUT WE DO HAVE INDIVIDUAL IRB.
THERE IS A LOT OF SHARING
BETWEEN THE DIFFERENT SITES TO
GET IT THROUGH.
MY UNDERSTANDING IS I DON'T KNOW
IF THERE ARE ANY SITES THAT DO
THIS OR USE THIS TYPE OF DATA
AND MY GUESS IS A HYBRID AND
THEN TO HAVE A SEPARATE IRB AND
THEN USE THAT.
BUT SINCE THE DATA IS NOT MOVING
TO ANOTHER SITE AND IT'S DONE
LOCALLY THEY CAN GO THROUGH IT
RELATIVELY QUICKLY.
>> LET ME OPEN THIS UP FOR MORE
SYNTHETIC DISCUSSION.
SO WITH NEI AND THE ANCILLARY
STUDY AND THE STANDARDS AND DATA
MODELS RELATING TO ALL OF US WE
WOULD LIKE TO PUT STANDARDIZE
EYE DATA COMMENTS AND QUESTIONS
FROM THE GROUP?
>> AS A MEMBER OF ALL OF US.
THERE ARE MANY PEOPLE THAT DON'T
HAVE ACCESS TO E-MAIL.
>> THE WAYS WE REACH OUT VERY A
LOT ACROSS THE COUNTRY.
WE HAVE 170 DIFFERENT COMMUNITY
ENGAGEMENT PARTNERS AND THEN ALL
SORTS OF DIFFERENT GROUPS.
NATIONAL ALLIANCE FOR HEALTH AND
THAT ENGAGES OLDER INDIVIDUALS
AND THERE ARE LOTS OF THESE
DIFFERENT GROUPS AND THEY DO
BAPTIST CONVENTIONS AND CHURCH
-BASED ENGAGEMENT SO THERE IS
LOTS OF DIFFERENT WAYS.
SON HAVE COMMUNITY CENTERS OR GO
THROUGH PROVIDERS AND THEN WE
HAVE MEDICAL CENTERS THAT ARE
FUNDED.
WE ALSO DO OUTREACH AND TALKING
TO OTHER PARTNERS IN THAT
PROCESS ALSO SNAIL MAIL.
BUT IT VARIES SO WE HAVE
HEALTHCARE PROVIDER OUTREACH
INCLUDING RADIO OR LOCAL TV AND
BUSES AND STUFF LIKE THAT IT
VARIES BY AREA.
THE BIGGEST THING IS
CONTRIBUTING AND WHAT WE TALK
ABOUT THE FUTURE OF RESOURCE
PLANT AT THE FUTURE OF RESEARCH
BUT THEN WE TRIED TO TURN VALUE
THROUGH GENOMIC RESULTS AND
OTHER TEST WE CAN COME UP WITH
SO THE CURRENT MENTAL HEALTH AND
WELL-BEING SURVEYS.
THOSE ARE JUST ENGAGING AND
FUN.
WITH THOSE GENOMICS PIECES.
THAT HAD A REAL HEALTH BENEFIT.
AND THERE ARE OTHER PLACES TO
HAVE MORE EXPLICIT VALUE.
>> I'M TALKING ABOUT AS A
LAYPERSON WHO HAS NO IDEA.
SO WHAT IS A LAYPERSON GETTING
OUT OF IT?
>> I THINK HOPEFULLY
CONTRIBUTING TOWARD THE
CONDITIONS OF THE DISEASES THEY
KNOW ABOUT TO SOME DEGREE.
BUT THE GENOMICS PIECE 3 PERCENT
HAVE A VARIANT THAT COULD CHANGE
THEIR HEALTH AND GENETIC
COUNSELING AND 96 PERCENT HAVE
TO BE EXPOSED TO MEDICATION OF
INTEREST.
THAT COULD HAVE A REAL HEALTH
BENEFIT.
IT VARIES BY PEOPLE.
WITH THE VALUE FOR YOU FOR
SOMEONE ELSE'S DIFFERENT.
AND WE JUST TRY TO THINK ABOUT
WHAT IS VALUABLE TO PEOPLE.
I GUESS I SHOULD BE ASKING
TURNING THIS INTO A QUESTION
WHAT WOULD BE MORE VALUABLE?
>> PERSONALLY I DON'T KNOW.
BUT WORKING IN THE CLINIC
HOSPITALS BUT I DON'T SEE ANY
SIGNS OF THIS.
>> CAN WE GIVE YOU SOME?
>> YES I WOULD LIKE SOME.
[LAUGHTER]
>> I WOULD REALLY LOVE YOUR
OPINIONS ON THE MULTI- CENTER
STUDY AND THE CRITERIA YOU WOULD
USE TO HAVE A GOOD
REPRESENTATION OF THE UNITED
STATES?
DO USE ACADEMIA OR SOCIAL
ECONOMICS IT'S IMPORTANT WHEN
YOU DO A MULTI- CENTERED STUDY
AND I HAVE NOT SEEN ANY REAL
CRITERIA FOR PEOPLE WHO HAVE
EXPERTISE IN THE AREA BUT IT'S
VERY DIFFERENT.
I AM CURIOUS ABOUT THE IDEAS YOU
HAD WITH REGARD TO THAT.
>> I THINK IT DEPENDS IT IS CASE
SPECIFIC SO IN THE PAST I STILL
NEED THE PROGRAM AND THAT WAS
VERY MUCH GRASSROOTS PARTICIPANT
DRIVEN BUT WE DID LOOK AT THE
SAME THINGS WE'RE ARE THE PEOPLE
COMING FROM?
OR HOW FAR THEY TRAVELED TO A
SITE TO HELP THEM ENROLL AND
THEN THE TYPICAL THINGS LIKE
RACE AND ETHNICITY.
AND FOR THE ODYSSEY THERE ARE A
LOT OF TOOLS THEY CREATED TO
LOOK AT EACH DATA SET AND IT IS
FIT FOR USE.
>> SO THOSE TEND TO BE SITE
SPECIFIC.
SO WHEN YOU SELECT THE PATIENTS
THAT WILL BE A PART OF THE STUDY
THEY USE A LOT OF ADVANCED
METHODOLOGIES SO YOU TRY TO
LIMIT THE DIFFERENT CONFOUNDING
FACTORS INFLUENCING YOUR
OUTCOME.
SO IT DOES DO THAT WITH EACH
DATABASE BUT THE QUESTION GOES
BEYOND THAT SO HOW DO WE HAVE
ENOUGH DIVERSITY IN THE FIRST
PLACE?
DO WE HAVE ENOUGH COVERAGE AND I
DON'T THINK WE HAVE ENOUGH
METRICS FOR THAT YET FROM WHAT I
HAVE SEEN HER THAT WE HAVE
CONSIDERED BUT THAT IS SOMETHING
WE WILL WANT TO CONSIDER
HOPEFULLY IF WE GET THIS STARTED
IN A STRATEGIC ABOUT SUPPORTING
THE SITES REPRESENTING DIFFERENT
POPULATIONS.
>> I ENJOYED HEARING ABOUT ALL
OF US.
IF I UNDERSTOOD YOU TARGETING
1 MILLION PARTICIPANTS.
THAT IS AMAZING.
OBVIOUSLY ARE DOING A GREAT JOB
AT RECRUITING.
AND THEN HOW YOU LOWER THE
BARRIERS TO PARTICIPATION ARE
YOU CAPTURING DATA ON HOW THIS
HAPPENS TO THOSE WHO SAY I WILL
NOT DO THIS BECAUSE XYZ?
>> IT'S A GREAT QUESTION.
IT IS HARD TO KNOW WHO DOESN'T
COME WHEN IT IS A GENERAL
APPEAL.
THIS IS JOSH.
WE DO KNOW DEPENDING WHERE THEY
ARE ON THE PATHWAY WHAT THEY
MIGHT DECIDE IT IS MULTIPLE
STEPS.
THE PERSON WHO DOES PRIMARY
CONSENT DOESN'T HAVE TO DECIDE
TO CHOOSE WHETHER OR NOT.
SO WE CAN LOOK AT THOSE PARTS OF
THE PATHWAY.
WE KNOW A LOT OF PEOPLE REPLY TO
AN E-MAIL THAN A HEALTHCARE
PROVIDER ORGANIZATION OR YOUR
DOCTORS TELLING YOU ABOUT IT.
THAT MAKES MORE SENSE.
I DO MY CVS E-MAILS WITHOUT
READING THEM.
SO WE DO TRY TO LEARN WHAT WE
CAN IN THE PROCESS AND TO LOWER
THE BAR AND ENSURE PEOPLE OF
WHAT WE ARE DOING TO PROTECT
THEIR DATA AND TO USE IT IN A
TRUSTWORTHY MANNER.
BUT WE ALSO UNDERSTAND WE HAVE
TO BE HONEST SO THE BIGGEST
CONCERN IS ABOUT PRIVACY AND
SECURITY OF DATA.
A LOT OF PEOPLE DON'T WANT
GENETIC RESULTS BACK MORE PEOPLE
WANT ANSWERS BECAUSE THEY DON'T
WANT TO KNOW.
THE FIELD WHAT THEIR HEALTH IS
AND THEY DON'T WANT TO.
AND THERE ARE INTERESTING PLACES
FOR US TO LEARN MORE.
>> A SECOND QUICK QUESTION WITH
ALL OF THESE PARTICIPANTS THERE
IS A GOOD OPPORTUNITY TO FLAG
NOT JUST GAPS THAT DON'T APPLY
TO THE SITUATION BUT EHR
MISTAKES.
YOU HAVE ALL OF THIS DATA.
SOME MISTAKES ARE CLEAR LIKE
OMISSIONS NUMBERS ARE CRAZY
COMPARED TO THE NORM.
IS A SOMETHING YOU ARE TOUTING
AS ANOTHER POTENTIAL BENEFIT?
IF YOU SIGN UP WITH US YOU CAN
FIND SOMETHING WRONG WITH YOUR
RECORD?
>> THE HMO MAY HAVE SOMETHING TO
SAY ABOUT THAT.
THERE IS A WORKING GROUP AND
BURIED IN THERE IS THE IDEA THIS
COULD POTENTIALLY BE A CASE AS
WE CAN TAKE THE EHR DATA WE HAVE
TO VISUALIZE TO GIVE AN
OPPORTUNITY TO PROVIDE
FEEDBACK.
IT CAN BE AS SIMPLE AS SHE
STOPPED MEDICATION.
DID SHE HAVE A SIDE EFFECT?
WORK COULD BE I NEVER HAD THIS.
AND THEN SEEING A SODIUM OF 2000
IS CATEGORIZED AS WHAT?
THAT IS WRONG.
AND SOME OF THE OMOP STUFF CAN
CATCH THOSE BUT THEN IT IS A
WRONG DIAGNOSIS THOSE ARE REAL
OPPORTUNITIES.
GREAT THOUGHTS WE DON'T HAVE
THEM YET BUT THAT'S A GREAT
OPPORTUNITY.
>> BANKS.
-- -- THINKS YOU ARE ABLE TO USE
HISTORICAL DATA AS WELL AS THE
DATA THAT YOU ARE COLLECTING IN
REAL TIME.
IS THERE ANY THOUGHT FROM THE
POPULATION -BASED STUDIES
COLLECTED OVER TIME TO BE A MORE
TARGETED POPULATION AND THAT
SOME OF THEM DO HAVE GENETIC
DATA AND OTHERS HAVE SAMPLES TO
BE TYPED?
IS THAT POSSIBLE?
>> IT IS POSSIBLE WE HAVE NOT
DONE IT YET WE HAD A FEW
DISCUSSIONS WITH RESEARCH
COHORTS FOR ALL OF US THAT ARE
LINKABLE OR CAN BE INCORPORATED.
BUT WE HAVE NOT DONE THAT YET
>> OTHER COMMENTS QUESTIONS?
>>> I JUST WANT TO GRATULATE
YOU, IT'S A
>> PROGRAM.
YOU GUYS ARE DOING A GREAT JOB
WITH THIS.
>> THANK YOU.
>> THANK YOU SO MUCH FOR
SHARING.
INCREDIBLE PROGRAM.
IT'S EXCITING THAT YOU'RE
CAPTURING THAT ONE TIME POINT
DATA AND YOU GET A SNAP
PICTURE.
BUT THAT'S IMPORTANT, DO YOU
HAVE A IDEA OF HOW MANY OF THE
SUBJECTS THAT IS IMAGE GOING.
THE DATA IS OBTAINED AT
DIFFERENT TIME POINTS?
IF NOT CAN YOU DO SOMETHING, I
KNOW IT'S NOT EASY.
TO HAVE THE SUBJECT COME BACK
AGAIN.
BUT YOU HAVE THE POTENTIAL TO
GET SOME DATA.
IS THAT POSSIBLE?
>>> YES, MAYBE I'LL START IT.
SO, A COUPLE THINGS, LODGE GA
TUNE NATIONTY IS IMPORTANT.
WE TO GET NEW DATA AND WE
COLLECT DATA, FROM THEIR EH
R.S AND WE ARE TALKING ABOUT A
FORMAL REASSESSMENT AS WELL.
WHICH WE'LL START IN 2024.
CARRY DO YOU WANT TO TALK
ABOUT THE EYE COMPONNEGLIGENTS
AND YOU MAY HAVE LOOKED AT THE
DATA.
>> SO, I HAVE LOOKED INTO THE
RESEARCHER WORKBENCH ON THE
OCCULAR DATA, AND LODGE GA
TUDE NALLLY, IT IS A LITTLE
SPARSE AND, THERE'S ACTUALLY
LIKE A HIGHER PROPORTION OF
FLAW COMMA OR DIAGNOSIS.
BUT, IT IS JUST SO SPARSE THAT
IT IS A LITTLE CHALLENGING TO
MAKE SOME BROAD STATEMENT BEST
THAT. BUT WITH THE OCCULAR
IMAGING, WE ARE HOPING.
WE'RE HAVING SOME DISCUSSION.
THERE'S THE PO DIG FOR
BUILDING THIS INTO
REASSESSMENTS.
AND THEN THAT COULD BE CAP
SHOOFERD AT SEVERAL TIME
POINTS.
AGAIN, WITH LIKE COUPLE LINK
THAT WITH TO THE OCCULAR
MEASURES COULD BE REALLY
POWERFUL DATA.
YES.
>> LET'S -- IT'S DON, HAVE YOU
ONE, BUT LET'S TAKE THAT AS
THE LAST COMMENT BECAUSE OF
THE TIME.
IF WE HAVE OTHER COMMENTS
LET'S SAVE THEM FOR THE VERY
END.
DON, LAST.
>> GREAT, THIS IS DON.
I JUST, WANTED HAD TO EXPRESS
A TREMENDOUS PRECIPITATION FOR
THE HUGE AMOUNT OF WORK THAT
YOU'RE ENGAGED IN AND LIKE
JAMES, I'M GRATITUDE OR
ENCOURAGED THAT RECRUITMENT IS
GOING WELL.
I THINK SUSPICION OF SCIENCE
OR WILLINGNESS TO PARTICIPATE
IN SCIENCE IS MORE DIFFICULT
NOW THAN IT WAS 20 YEARS AGO.
SO I'M VERY ENCOURAGED THAT
PEOPLE ARE WHICH WILL TO
PARTICIPATE.
THIS EFFORT REPRESENTS A
TREMENDOUS OPPORTUNITY FOR
SCIEN, WHAT WE CAN DERIVE FROM
BIG DATA AND I'M PREACH HATING
A TREMENDOUS OPPORTUNITY AND
RESPONSIBILITY TO BRING THIS
BACK TO PUBLIC TO LET THE
PUBLIC KNOW THAT PARTICIPATION
EQUALS THEN EQUALS AN
IMPROVEMENT IN THEIR OVERALL
HEALTH AND SORT OF A
CORRECTING THE PUBLIC
PERCEPTION, DUE TO PAST
INJUSTICES, THAT, PUBLIC
SCIENCE AND YOUR PUBLIC'S
PARTICLES IN SCIENCE CAN BE
FOR THEIR BENEFIT.
SEEMS LIKE A MILLION VOICES
WILL SPEAK VERY, VERY LOUDLY
THAT, AS PARTICIPATION IN
RESEARCH EQUALS A BETTER LIFE
AND INCREASING THE JUSTICE IN
THE WORLD.
>> THANK YOU VERY MUCH.
I WANT TO THANKS, WELL, THE
REASON THAT WE WENTED TO HAVE
THIS SYMPOSIUM IS A COUPLE, I
VIEW OUR JOB AS TO TRY TO DO
THINGS THAT BENEFIT THE ENTIRE
COMMUNITY.
ONE OF THEM IS PROVIDING DATA
IN THE HANDEST COMMUNITY AND I
DO THINK WE HAVE A VISION
COMMUNITY.
WE'RE EXCITED ABOUT THAT.
ONE THING, AND SO, MICHELLE IS
SOMEONE WHO'S PHD IS COMPUTER
SCIENCE AND, I THINK WE NEED
MORE PEOPLE LIKE MICHELLE, AND
THE OTHER THING, YOU HAD MADE
A COMMENT ABOUT PRIVACY AND
HOW DIFFERENT INSTITUTIONS
BEHAVE DIFFERENTLY AND I THINK
THAT'S A PROBLEM.
I THINK THAT WE ENTER A
LANDSCAPE WHERE WE'RE TRYING
TO FIGURE OUT THE RULES AND,
THE REASON PEOPLE HAVE
DIFFERENT VIEWS IS THERE'S NOT
AT OBVIOUS ANSWER.
EMILY, AND JOEL ARE LEADING A
WORK GROUP THAT'S TRYING TO
LOOK AT THIS, WITH RET NALL
IMAGE DATA.
IT TURNS OUT TO BE TOUGHER.
BUT WE'RE HOPING TO GET AND
AARON, TOGETHER WITH SOMEONE
AT VANDERBILT, THAT JOSH KNOWS
WELL.
BRAD ARE ON THE PROGRAM AND
THEY HAVE BEEN DEALING WITH
THIS ISSUE WITH RETINAL IMAGE
DATA AS WELL.
SO WE'RE HOPING OUT OF THAT IS
GOING TO COME SOME ISSUES THAT
WE HOPE CAN GIVE A LITTLE BIT
MORE STANDARD TODAYSATION,
ABOUT ISSUES THAT ARE TOUGH.
BUT JOSH, A BIG THANK YOU TO
ALL OF YOU FOR SPEAKING.
>> SO, CAN WE TURN TO YOU --
>> YES.
>> THANK YOU VERY MUCH.
THAT WAS REALLY INFORMATIVE
AND WE MAKE THE SLIDES
AVAILABLE TO YOU AND WE CAN
FOLLOW-UP WITH A LEARN TO
WEBSITE AND WHATEVER OTHER
INFORMATION AND THANK YOU FOR
YOUR INTEREST IN THIS.
WE'RE GOING TO MOVE ONTO OUR
LAST ITEM, BEFORE LUNCH.
AND THAT'S CONCEPT
CLEARANCES.
TODAY WE HAVE TWO CONCEPT
CLEAR FINANCES TO PRESENT TO
YOU FOR YOUR CONSIDERATION AND
JUST A REMINDER WE PRESENT
THESE CONCEPTS TO YOU FOR
POTENTIAL FUNDING
OPPORTUNITIES, WE'RE THINK
GOING ABOUT DEVELOPING.
WE WANT TO GET YOUR FEEDBACK,
YOUR APPROVAL TO THINK ABOUT
DEVELOP GOING THESE MORE IF
YOU THINK THEY SHOULD BE
PRIORITIES AND WHETHER WE
DEVELOP THEM OR NOT DEPENDS ON
BUDGET AND THE YOUR INPUT.
SO I DIDN'T ASSIGN ANY
SPECIFIC DISCUSSIONS FOR EACH
OF THESE BECAUSE I WANT TO
ENCOURAGE EVERYONE TO PROVIDE
INPUT ON THEM.
WE HAVE ABOUT 15 MACHINES FOR
EACH.
SO FIVE MINUTES FOR
PRESENTATION AND TEN MINUTES
FOR DISCUSSION. THE FIRST
CONCEPT IS GOING TO BE
PRESENTED BY DOCTOR SHERIDAN,
WHO MANAGES THE LOW VISION.
SO GO AHEAD.
>> THANKS FOR THE
INTRODUCTION.
I REALLY APPRECIATE THE
OPPORTUNITY TO PRESENT THIS
CONCEPT FOR COUNCIL'S
CONSIDERATION TODAY.
SO THE OVERALL GOAL OF THIS
INITIATIVE THAT I'LL BE
SCRIBING IS TO STIMULATE
TRANSLATIONAL EFFORTS TO
DEVELOP ACCESSIBILITY TOOLS
FOR INDIVIDUALS WHO ARE LIVE
GOING WITH VISUAL IMPAIRMENT.
WHAT I HOPE TO CONVEY IS THAT
THESE ACTIVITIES, WILL SUPPORT
ADVANCING THE GENERAL EYE
MISSION BUT, ALSO, IN
PARTICULAR A DIRECTIVE IN NEI
STRATEGIC PLANS, EMERGENCIING
OPPORTUNITIES WHICH IS TO
DRIVE RESEARCH, TO EXPAND
OPPORTUNITY FOR PEOPLE WHO ARE
BLIND OR REQUIRE VISUAL
REHABILITATION.
SO THE RATIONALE IS FAIRLY
STRAIGHT-FORWARD.
THAT IS DESPITE REMARKABLE
MEDICAL ADVANCES THAT HAVE
BEEN MADE IN TREATS O GOING
AND PREVENTING BLINDNESS, AM
REMAIN INCURABLE.
AND THAT MEANS 7,000,000
PEOPLE IN AMERICA HAVE VISUAL
IMPAIRMENT.
THESE INDIVIDUALS HAVE A
NUMBER OF CHALLENGES, IN
PERFORMING ACTIVITIES OF DAILY
LIVING, ATTAINING ENGE, AND
ENGE OPPORTUNITIES ATTAIN
GOING EMPLOYMENT, AND
MAINTAINING BASIC GOOD
HEALTH.
NOW HISTORICALLY,
ACCESSIBILITY DESIGN HAS,
THOSE EFFORTS HAVE ADDRESSED
MEETING THESE CHALLENGES BY
DEVELOPING TOOLS THAT CAN
SUPPORT PRODUCTIVE AND QUALITY
OF LIFE FOR PEOPLE WHO ARE
EFFECTED BY VISUAL IMPAIRMENT.
BRAILLE, WHITE CONTAINS,
MAGNIFYING DEVICES.
THOSE ARE THE MOST ESTABLISHED
AND THAT'S KNOWN OF THESE
ACCESSIBILITY TOOLS.
BUT THERE ARE A NUMBER OF
TOOLS THAT DO EXIST AND ARE
WIDELY USED.
BUT WE SEE THIS PARTICULAR
POINT IN TIME, THERE IS A
UNIQUE OPPORTUNITY TO
TRANSFORM ACCESSIBLEBILITY
EFFORTS GIVEN THE RECENT RAPID
GROWTH AND INCREDIBLE INNOVATE
GOING IN NEW TECHNOLOGIES.
THIS SLIDE PRESENTS THREE
EXAMPLES ILLUSTRATING THE
INTEGRATION OF 3D PRINTED
TECHNOLOGY TOWARDS DEVELOPING
ACCESSIBILITY TOOLS FOR BLIND
INDIVIDUALS.
ON THIS SLIDE ON THE LEFT-SIDE
IS ADD PICTURE OF A WOMAN WHO
IS TOUCHING THE CONTOWERS
AFTER 3 DIMENSIONAL MAP OF A
FLOOR OF A UNIVERSITY BUILDING
ON CAMPUS.
SO, BEING ABLE TO GAIN THIS
TACTILE INFORMATION ALLOWS HER
TO PLAN A ROUTE TO HER
CLASSROOM THAT SHE CAN MAKE
BEFORE ARRIVING AT THE
BUILDING.
IN THE MIDDLE IS A PICTURE OF
A YOUNG CHEMISTRY STUDENT WHO
IS PLACING A SMALL STRUCTURE
OF A PROTEIN INTO HIS MOUTH
AND THEN CAN USE THE TACTILE
SENSITIVITY OF HIS TONGUE TO
VISUALIZE AND LEARN ABOUT THAT
COMPLEX STRUCTURE OF THAT
PROTEIN.
ON THE FAR RIGHT IS A PICTURE
OF A GENTLEMAN WHO IS
INTERACTING WITH A PROTOTYPE
TOUCHED BASE DEVICE THAT
MIMMICKS THE 3-DIMENSIONAL
OBJECT THAT HE HAS DESIGNED ON
THE COMPUTER.
AS A RESULT HE CAN ENGAGE IN A
BETTER DESIGN PROCESS AND PULL
UP BASICALLY A PRINT PREVIEW
BEFORE HE SENDS THE JOB TO
THAT 3D PRINTER.
SO THAT'S SAVING HIM TIME AND
EXPENSE.
BUT OF COURSE, THE
OPPORTUNITIES ARE NOT LIMITED
TO 3D PRINTING TECHNOLOGY, WE
WOULD ARGUE THAT OPPORTUNITIES
ARE RELATIVELY LIMITLESS.
SO JUST AS FEW EXAMPLES TO
CONSIDER, ADVANCES IN WEARABLE
SENSE GOING GOING TECHNOLOGIES
COULD BE APPLIED TO EXPAND
MOBILE APP SOLUTIONS FOR MORE
COMPLEX ENVINETMENTS.
ARTIFICIAL INTELLIGENCE
PROVIDES PROMISE.
MECHANICAL ENGINEERING
DEVELOPMENTS COULD BE USED TO
AUGMENT WEARABLE KEYBOARDS.
VIRTUAL REALITY SYSTEMS COULD
INCORPORATE MULTIPLE SIGNING,
AND, CONVEY VISUAL
INFORMATION.
AND MATERIAL SCIENCE RESEARCH
COULD BE DIRECTED TO DEVELOP
NEWCOME POSSIBLE SITS FOR
SMART REFRESHABLE BRAILLE
DEVICES.
SO, SIMPLY STATED WE SEE GREAT
POTENTIAL IN HARNESS GOING
ADVANCES IN TECHNOLOGY
DEVELOPMENT TO REALLY INNOVATE
ACCESSIBILITY TOOLS.
THERE ARE KEY ELEMENTS THAT WE
SEE.
FIRST, THE VERY IMPORTANT TO
ENGAGE FRANCE-DISCIPLINARY
EXPERTISE.
WE NEED THE TECHNOLOGY WIZARDS
ON THE RESEARCH TEAMS BUT ALSO
INCORPORATING OTHER EXPERTISE
SOUTHEASTER GO NOL MIX, SOCIAL
SCIENCE SKIS, REHABILITATION
SCIENCE.
ALL OF THOSE COULD PROVIDE A
MUCH MORE PRODUCTIVE DIALOGUE
ACROSS DEPARTMENTS, SCHOOLS
AND MINDSETS.
CERTAINLY MOST IMPORTANT WOULD
BE TO INCLUDE INDIVIDUALS WITH
LIVED EXPERIENCE BECAUSE THEY
CAN PROVIDE THE INFORMATION
ABOUT WHAT PARTICULAR TOOLS
WOULD BE IMPORTANT IN
ASSESSING IMPORTANT NEEDS.
PROJECTS SHOULD ALSO APPLY
USER CENTER DESIGN EARLY IN
TOOL DEVELOPMENT.
IN OTHER WORDS, DON'T RED TRO
FIT A TECHNOLOGY TO TRY TO
ADDRESS AN ISSUE.
BUT REALLY, THE PLANNING
SHOULD BE DRIVEN TO SERVE THE
GOALS AND NEEDS OF THE EVENUAL
USER.
TO REALLY MAXIMIZE THE IMPACT
OF THESE PROJECTS THEY SHOULD
ADDRESS REAL WORLD CHALLENGES,
AND ALSO SHOULD ESTABLISH
PLANS FOR FAST AND AFFORDABLE
DISSEMINATION.
SO WE REALLY WOULD WANT TO SEE
THESE TOOLS GETTING OUT INTO
THE COMMUNITY.
ADDRESSING REAL ISSUES IN THE
COMMUNITY AND NOT SIMPLY
PRESENTED AS A SCIENTIFIC
CONFERENCE.
ALTHOUGH THAT'S GOOD, TOO.
>> SO, THANK YOU, I REALLY
APPRECIATE YOUR ATTENTION.
I LOOK FORWARD TO COMMENTS AND
INSIGHTS FROM COUNSISM THANK
YOU.
>> AS PERSON WHO HAS BEEN A
JUNKY FOR ACCESSIBILITY
DEVICES FOR A REALLY LONG
TIME, BRAVO TO YOU FOR PAYING
ATTENTION TO THIS.
I HAVE TAKEN ADVANTAGE OF AT
LEAST FIVE OF THE THINGS THAT
YOU DESCRIBED.
I WANTED TO DRAW YOUR
ATTENTION TO FACT THAT THERE'S
LEGISLATION PENDING, CALLED
THE WEBSITE AND SOFTWARE
ACCESSIBILITY ACT THAT REALLY
DOES A DEEP DRIVER INTO THE
DESIGN SEGMENT OF THIS WHOLE
DIALOGUE THAT'S BEEN GOING ON
NOW AS MORE AND MORE
ACCESSIBILITY DEVICES ARE
KEYED TO INTERNET
COMMUNICATION.
ALSO, AS A ACKNOWLEDGEMENT
THAT WHILE BRAILLE IS
CERTAINLY STILL UTILITZED AND
TAUGHT IN SCHOOLS, THE
AUDITORY SYSTEMS AND
PROCESSING ARE MORE EASILY
MARRIED TO THE WORLD OF THE
WEB.
PROBABLY, THAN EVER BEFORE.
SO, LIKELY, ARE MORE AN ISSUE
OF INTEREST PARTICULARLY
PEOPLE WHO ARE NOT BORN BLIND
BUT GO BLIND OVER TIME BECAUSE
BRAILLE IS A DIFFICULT THING
TO LEARN.
BUT IN PARTICULAR I WANTED TO
GIVE YOU ONE EXAMPLE YOU TALK
ABOUT MAKING THIS ACCESSIBLE
TO PUBLIC.
AND ECONOMICALLY ACCESSIBLE AS
WELL.
I FOUND MYSELF A TOURIST IN
ITALY, AND WE ADD VARIETY OF
TOUR GUIDES.
ONE, WENT TO PUBLIC LIBRARY,
PRINTED OUT SOME TWO
DIMENSIONAL MAPS OF SOME OF
THE SITES THAT WE WERE GOING
TO VISIT AND TOOK THEM TO A 3D
PRINTER AND PRINTED TACTILE
MAPS.
IN ADDITION HE WENT TO THE
LITTLE TOURIST KIOSK AND
BOUGHT A COUPLE OF THE
MINSURES THAT PEOPLE ARE SOLD,
WHICH HE HANDED TO ME AT
CRITICAL MOMENTS, ALONG THE
TOURS THAT I HAD AN
UNDERSTANDING OF WHAT THE
BUILDING.
HE TOLD ME HE INVESTED 20
EUROS IN THE ENTIRE PROJECT.
NO ONE HAD ASKED HIM TO DO IT
AND HE HAD SIMPLY SAT DOWN AND
TRIED TO FIGURE OUT THE BEST
WAY TO HELP ME UNDERSTAND IT.
NEEDLESS TO SAY THAT IS ABOVE
AND BEYOND WHAT MOST PEOPLE
WOULD EVEN CONSIDER.
BUT IT TIES SO BEAUTIFULLY
INTO THE ASPECTS THAT YOU
PRESENTED ON THE SLIDES.
BUT THIS IS THE ART OF GETTING
BY AND SO, IN TERMS OF DEALING
WITH PEOPLE WITH LIVED
EXPERIENCES, WE HAVE ALL THE
NON-PROFIT ORGANIZATIONS THAT
I'M SURE WOULD BE EXTREMELY
WILLING TO PROVIDE INFORMATION
TO PEOPLE WHO WOULD BE WILLING
TO SHARE THOSE EXPERIENCES.
BUT I REALLY STRONGLY
ENCOURAGE YOU TO TAKE A LOOK
THAT PIECE OF LEGISLATION.
BECAUSE IT REALLY GOES A LONG
WAY FORWARDS SCRIBING WHERE WE
ARE RIGHT NOW.
BUT THANKS.
IT'S GREAT.
>> THAT IS COMERRY, THANKS TO
YOU, THAT'S WONDERFUL I NOTED
THE LEGISLATION AND I NOTED
THE EXPRESSING THE ART OF
GETTING BY.
THANK YOU.
>> WELL, MY FURRY FRIEND,
WOULD BE VERY BLEEP TO ENGAGE
IN THAT PROTEIN YOU KNOW,
IDENTIFICATION PROCESS
[LAUGHTER]
>> YOU DID NOTICE, THERE WAS A
TETHER ON IT. SO YOU DON'T
SWALLOW IT.
[LAUGHTER]
>> THANK YOU.
THANKS SO MUCH, AND THIS IS
REALLY THE KIND OF WORK I HAVE
BEEN DOING AND SHERIDAN HAS
BEEN SUPPORTIVE.
SO I'M DELIGHTED THAT YOU'RE
PRESENTING THIS.
JUST TO ADD A FEW THINGS.
ONE TERM THAT JENNY MENTIONED
WAS UNIVERSAL DESIGN.
IN THE PAST I THINK A LOT OF
WHAT WAS OFTEN TERMED ASSISTED
TECHNOLOGY AND I LIKE
ACCESSIBILITY TOOLS.
BUT I THINK A LOT OF
TECHNOLOGY WAS STIGMATIZED AND
VIEWED AS VERY SEPARATE.
IF YOU ARE BLIND YOU NEED
SOMETHING TACTILE.
LET'S BE OPEN TO UNIVERSAL
DESIGN PRINCIPALS, THAT'S SOME
BEAUTIFUL WORK THAT MY
COLLEAGUING STEVE IS DOING ON
MAKING TACTILE MAPS THAT ARE
ALSO BEAUTIFUL.
SO, I WOULD CHARACTERIZE THEM
AS TWO-AND-A-HALF
DIMENSIONAL.
VISUAL STUNNING, AND IT IS
HELPFUL.
AND TACTILE, SO, WHY NOT
COMBINE THAT.
I THINK IT'S IMPORTANT TO TRY
TO NORMALIZE THE AVAILABILITY
OF THIS, BECAUSE IN THE PAST
IT WAS CONSIDERED LIKE THIS
VERY UNUSUAL SORT OF MEASURE
OF LAST RESORT.
BUT THE PRINCIPAL OF UNIVERSAL
DESIGN MEANS IT'S GOOD FOR
EVERYBODY.
ALSO JUST AS A YES, YOU
MENTIONED OF COURSE, WANTING
TO INCLUDE INDIVIDUALS WITH
LIVED EXPERIENCE IN THE GRANTS
WHICH IS A NO-BRAINIER.
ARE THERE ANY MECHANISM THAT'S
MIGHT BE DEVICED TO
SPECIFICALLY INCENTIVIZE P.I.S
WITH DISABILITIES, TO ACTUALLY
APPLY?
THAT'S MY LAST COMMENT.
THANK YOU SO MUCH.
>> THANK YOU.
YES. THERE COULD BE.
CERTAINLY IF THERE WERE TO BE
WRITTEN UP WE COULD INDICATE
SUCH THINGS, IT WOULD BE VERY
IMPORTANT.
THANK YOU.
>> SO THIS IS PRETTY, SO I
THINK WHAT JENNY BROUGHT UP,
AND JAMES YOU ALLUDED TO, WHEN
YOU TALK ABOUT ACCESSIBILITY,
WE PUT THE ONUS ON THE
PERSON.
WHEREAS JENNY SPOKE ABOUT HOW
THE BUSINESS PROVIDER OR THE
PERSON YOU MIGHT INTERACT WITH
TO GET AT SERVICE IS ACTUALLY
PROVIDING IT.
I JUST WONDER WHETHER THERE'S
MORE WORK THAT NEEDS TO BE
DONE WHEN WE DO OUR WORK IT IS
NO THE INDIVIDUAL WHO IS THE
SUBJECT BUT IT'S THE
PROVIDERS, THE BUSINESSES, THE
HOSPITALS, THE PEOPLE WHO
PROVIDE ALL THOSE THINGS WITH
WHICH THEY NEED TO INTERACT.
AS MUCH AS WE WANT TO HELP THE
INDIVIDUAL, THE SYSTEM BASED
CHANGE, CAN HELP ALL THOSE
INDIVIDUALS PEOPLE WITH NORMAL
VISION WHO JUST FORGOT NAIR
GLASSES.
SO I THINK WE NEED TO BE NOT
ALWAYS PUTTING ALL THE BURDEN
ON THE PERSON WHO HAS THE
VISUAL IMPAIRMENT.
>> THANK YOU.
>> THIS IS DON.
AS PART OF AVAILABILITY,
STRUCK ME ONE MIGHT BE
ECONOMIC AS TECHNOLOGY BECOMES
MORE AND MORE SOPHISTICATED
MAKING IT WIDELY AVAILABLE TO
BUSINESSES TO INDIVIDUALS,
THAT THIS MIGHT BE A POTENTIAL
PROBLEM THAT CERTAIN PEOPLE
WHO COULD BENEFIT FROM THESE
TECHNOLOGIES WOULD BE PRICED
OUT OF THAT MARKET.
SO I'M WONDERING, IF
AVAILABILITY, AFFORDABILITY
MAKING SURE THAT WE'RE NOT
CREATING DISPARITIES, AS WE
GET MORE TECHNOLCAL
SOPHISTICATED.
>> THIS IS COMERRY, SO THANKS
FOR THAT. I AGREE.
I THINK A NICE EXAMPLE IS THE
3D PRINTING WHICH NOW IT IS
INEXPENSIVE COMPARED TO WHEN
IT WAS FIRST ROLLED OUT.
ONE WOULD HOPE THAT SOME OF
THESE TECHNOLOGIES AS THEY
BECOME MORE AVAILABLE, THE
PRICE POINT WOULD BE LESS
PAINFUL.
BUT I COMPLETELY AGREE.
>> CAN I JUST ADD ONE, MAYBE
THOUGHT, AND IN MY EXPERIENCE
A FEW OF THESE TECHNOLOGIES
REQUIRE AN INDIVIDUAL TO VISIT
A REHABILITATION OR LOW VISION
SPECIALIST AND THEY ARE VERY,
VERY FEW AND THERE'S A VERY
LONG WAIT.
SO I THINK I WOULD ENCOURAGE
TO THINK ABOUT WAYS TO BUILD
THAT CAPACITY.
BECAUSE IT DOESN'T NECESSARILY
ALWAYS HELP TO HAVE TOOLS IF
YOU CAN'T ACCESS THEM THROUGH
PROVIDERS AND TRAINED PEOPLE
WHO HELP YOU, CAN TRAIN AND
HELP YOU USE THOSE TO BEST OF
YOUR ABILITY.
>> THANK YOU.
THANKS EVERYONE.
I THINK WE NEED TO MOVE ON.
BUT IF YOU HAVE ADDITIONAL
THOUGHTS PLEASE FEEL FREE TO
SHARE THEM VIA EMAIL.
>> SO MAY I HAVE A MOTION NO
APPROVE THIS CONCEPT FOR
POTENTIAL DEVELOPMENT INTO A
FUTURE FUNDING OPPORTUNITY.
JAMES THANK YOU.
THANK YOU.
ALL IN FAVOR, IS THERE ANYONE
OPPOSED?
OKAY.
THE MOTION PASSES.
>> THANKS SO MUCH.
THAT WAS REALLY INTERESTING
AND GREAT DISCUSSION. SO THE
NEXT CONCEPT WE HAVE IS FOR A
RENEWAL OF THE NEI-INDIA
COLLABORATIVE RESEARCH
PROGRAM.
AND IT IS GOING TO BE PRESENT
BY CHARLES WRIGHT, A PROGRAM
OFFICER, AND BEFORE HE STARTS
I WANT TO THANK LISA, WHO HAS
MANAGED THIS PARTICULAR
PROGRAM FOR MANY YEARS AND HAS
REALLY DONE A LOT TO ENSURE A
SMOOTH TRANSITION.
SO WITH THAT, CHUCK.
>> THIS IS CHARLES WRIGHT.
I WOULD LIKE TO THANK COUNCIL
FOR THE OPPORTUNITY TO PRESENT
THIS CONCEPT CLEARANCE FOR THE
INDIA COLLABORATIVE PROGRAM.
SO, IN RECOGNITION OF THE
PUBLIC HEALTH CHALLENGES AND
THE GOAL FOR ENDING THE BURDEN
OF BLINDING DISEASE ON THE
CITIZENS IN U.S. AND INDIA,
GOVERNMENTS SIGNED A STATEMENT
OF INTENT IN 2005 TO ENCOURAGE
COLLABORATIONS.
THERE ARE MANY ADVANCETANC
ADVANCETANCE AND REASONS WHY A
COLLABORATION WOULD BE
VALUABLE.
FOR EXAMPLE, DIABETES, HAS
RISEN IN BOTH COUNTRIES IN THE
PAST 20 YEARS.
TYPE TWO DIABETES IS THE
PRIMARY RISK FACTOR.
CLIMATE CHANGE IS ALSO
IMPACTING BOTH OF OUR
COUNTRIES THE CHANGES IN
WEATHER PATTERNS, HAVE OFFERED
DISEASE FACTORS, TO TRANSMIT
DISEASES TO A GREATER PART OF
THE POPULATION AND THEY ARE
CARRYING DISEASES, AM CARRY
OCCULAR COMPLICATIONS.
ALSO AIR POLLUTION HAS BEEN
RELATED TO OCCULAR SYMPTOMS,
AND, CATEGORY RACKS.
THE COLLABORATION OFFER SOME
UNIQUE ADVANCETAGES, AM BRING
UNIQUE SKILL SETS AND
EXPERTISE, AND IN PARTICULAR
INDIA IS GOOD FOR BASIC
CLINICAL STUDIES.
HISTORICALLY SPEAKING, PATIENT
ENROLLMENT IS MUCH FASTER IN
INDIA AND CAN HAVE GREATER
NUMBER OF PEOPLE IN ROLLED IN
STUDIES AND FEWER OF THESE
PATIENTS HAVE BEEN LOSS TO
FOLLOW-UP.
SO IT'S A UNIQUE PATIENT
POPULATION THAT WE CAN WORK
WITH.
IN THE PAST THIS PROGRAM HAS
HAD A VERY BROAD SCOPE RANGING
FROM BASIC SCIENCE TO
TRANSLATIONAL SCIENCE.
AND WE'RE HOPING TO CONTINUE
THAT WITH THE RE-ISSUANCE
HERE.
THE RESEARCH PROGRAM FOCUSES
ON SIGNIFICANT PUBLIC HEALTH
TOPICS, INCLUDING AND THIS IS
BY NO MEANS A EXSAWSTIVE
LIST.
ASSESSING THE IMPACT OF
CLIMATE CHANGE RELATED, TO
OCCULAR DISEASE, DEVELOPING
AND TESTING STRATEGIES THAT
REDUCE CLIMATE CHANGE AND
IDENTIFYING COMMUNITIES AT
RISK FOR THESE SORTS OF
CLIMATE CHANGE RELATED IMPACTS
TO HELP IN THEIR MITIGATION.
STUDY GOING MECHANISM IN WHICH
POLLUTANTS CONATTRIBUTE TO EYE
DISEASE, AND I DEIFYING
JEANETTE PARTICULAR MARKERS
THAT PREDICT OR IMPACT RISK
AND RESPONSE TO INTERVENTIONS.
SINCE THIS PROGRAM WAS LAST
REISSUED, I WOULD LIKE TO
HIGHLIGHT TWO PROJECTS THAT
WERE FUNDED DURING THIS
PERIOD.
THE FIRST SHOWING IN THESE TWO
PROJECTS SHOW THE GAMUT OF THE
TIMES OF PROJECT THAT'S HAVE
BEEN FUNDED.
FIRST IS STRICTLY BASIC
SCIENCE.
IN THE U.S. AND INDIA, IN A
COLLABORATION THAT STARTED
BEFORE THEY APPLIED FOR
FUNDING UNDER THIS PROGRAM
WHERE THEY WERE USING EM TO
RESOLVE FRANCE SNAP PARTICULAR
PROTEIN COMPLEXES IN THE BRAIN
THAT HAVE BEEN ASSOCIATED WITH
INCOGNITION.
AND HERE, THE P.I.S ARE
CONTINUING THIS WORK BY USING
IT TO RESOLVE THE COMPLEX, AND
THAT HAVE BEEN IMPLICATED IN
NIGHT BLINDNESS, THE SECOND IS
MUCH MORE TRANSLATIONAL,
DOCTOR IN THE U.S. AND INDIA,
ARE WORKING ON RECRUITING
PATIENTS WITH MICRO OPEN THAT
WILL ME A TO SEQUENCE THEIR
ENTIRE GENOME, IN PARTICULAR,
THEY'RE INTERESTED IN VITAMIN
A.
ONCE VARIANCES, AND GENES HAVE
BEEN IDENTIFIED IN THESE
PATIENTS HE PLANS TO USE IT TO
DEVELOP ZEBRA FISH MODELS TO
STUDY HOW THESE VARIANTS MAY
IMPACT DEVELOPMENT.
AGAIN I WOULD LIKE TO THANKS
COUNCIL FOR THE OPPORTUNITY TO
PRESENT THIS AND I WOULD BE
WILLING TO TAKE ANY QUESTIONS
OR COMMENTS.
>> QUESTION, I ASSUME THIS IS
AN N I.H. WIDE PROGRAM,
CORRECT?
>>> THIS IS CHUCK, THIS IS
NEI.
>> OKAY.
HOW MANY CLIENTS HAVE BEEN
FUNDED THROUGH THIS PROGRAM SO
FAR.
>> PROGRAM SO FAR?
FOUR I BELIEVE.
>> SINCE 2005
>> YES.
>> THANKS.
>> AMONG, MAUREEN MCGWIRE,
AMONG THOSE FUNDED GRANTS,
WOULD THEY HAVE BEEN FUNDED IN
ANOTHER MECHANISM?
DO THEY NEED TO COME THROUGH
THIS PROGRAM IN ORDER FOR THEM
TO QUALIFY FOR FUNDING?
>>> SO, THEY DO NOT NEED TO
COME THROUGH THIS MECHANISM.
BUT THE ADVENTURE OF THIS
PROGRAM VERSUS TRYING TO JUST
USE A SUBCONTRACT IS WE CAN
ISSUE SUBCONTRACTS TO INDIA.
BUT, ON THE INDIA SIDE THEIR
EQUIP LENGTH OF STATE
DEPARTMENT, IT CAN TAKE 6-9
MONTHS OR LONGER.
SO THIS PROGRAM DOES NOT
INVOLVE DIRECT TRANSFER OF
FUNDS FROM THE U.S. TO INDIA.
SO ONCE THEY HAVE BEEN AWARDED
THEY CAN IMMEDIATELY START.
>> THANKS FOR SHARING.
CAN YOU WALK US THROUGH THE
PROCESS OF THE OFVEZ LOSING OF
THIS.
>> SURE, IN THE PAST WHAT HAS
HAPPENED IS AT THE SAME TIME,
THE U.S. BASED INVESTIGATORS
SUBMIT AN APPLICATION, AND
THEIR INDIAN COLLABORATOR
SUBMITS A APPLICATION TO THE
DI T., IN INDIA.
SO BOTH OF THOSE ARE
REVIEWED.
THE ONES, THE APPLICATIONS
THAT GET FAVORABLE FUNDING
RECOMMENDATIONS WE MEET TO
DISCUSS, NIH, OR NEI PROGRAM
OFFICERS AND OFFICIALS MEET
WITH OUR EQUIVVENTS IN INDIA
TO DISCUSS WHICH
APPLIAPPLICATIONS WE WOULD
SUPPORT.
>> DO YOU HAVE AN IDEA HOW
MANY GET FUNDED?
SORRY.
>> DO YOU HAVE AN IDEA HOW
MANY GET FUNDED?
>>> SO, AS I TOLD DOCTOR DANA
EARLIER, WE HAD FOUR
APPLICATIONS THAT HAVE BEEN
FINANCED.
>> HOW MANY APPLICATIONS WERE
SUBMITTED.
>> I THINK, I WOULD HAVE TO
CHECK THE NUMBERS AGAIN.
I CAN GET BACK TO YOU.
YOU BUT I THINK IT'S BEEN 17
OR 18.
>> SO, SEVERAL CLINICAL TRIALS
THAT HAVE USED INDIA AS ONE OF
THE SITES IS THERE A SPECIFIC
REASON THAT THEY WERE NOT
ALLOWED AS PART OF THIS.
>> SO, THE CLINICAL TRIALS,
WHEN THE PROGRAM WAS FIRST
CONCEIVED, CLINICAL TRIALS
WERE NOT ALLOWED AND LOOKING
THROUGH OUR DOCUMENTS WE'RE
TRYING TO SEE IF THERE'S
ANYTHING THAT WOULD PROHIBIT
IT.
BUT AT THIS POINT WE DON'T SEE
A STRONG REASON TO CHANGE THAT
UNLESS THERE'S A PRESSING
NEED.
>> DO YOU WANT TO -- YES, SO,
CLINICAL TRIALS ARE USUALLY
DOWN BY OUR MECHANISMS, AND
THIS IS AN "R" MECHANISM.
SO THAT'S WHY WE DIDN'T HAVE
ANY CLINICAL TRIALS ON THIS
PARTICULAR ONE.
IT IS MORE GENERAL BIOLOGICAL
STUDIES.
MINIMAL RISK POSSIBLE BUT IT
IS NOT TO DO REGULAR MULTI
SITE.
>> JUST, THIS IS CATHY, WE DO
OUR CLINICAL TRIALS
PORTFOLIOS, MANAGED, BY DON
AND JIMMY DO HAVE, THERE ARE A
NUMBER OF SITE THAT'S VERY ARE
IN INDIA.
WE DO IT A LITTLE DIFFERENT
WAY.
GIVES US MORE OVERSIGHT.
>> WHAT HAPPENS IF A GRANT
GETS FROM U.S., AND DOESN'T
GET FROM THE OTHER SIDE?
WHAT HAPPENS.
>> THIS IS ONE UNFORTUNATE
THINK THAT HAPPENS IS, THE
APPLICATION'S THE U.S. SIDE
WILL NOT BE FUNDED EVEN IF
THEY DO RECEIVE A FAVORABLE
SCORE.
>> MURRINE MCGWIRE, I'LL JUST
COMMENT THAT A NUMBER OF THE
ADVANTAGES THAT YOU LISTED,
FOR THIS TYPE OF COLLABORATION
ARE VERY DISTANT FROM THE
PROGRAMS THAT HAVE BEEN
FUNDED.
THESE WERE, YOU KNOW, THE TWO
FUNDED WERE BASIC SCIENCE AND
MANY OF THE ADVENTURE WERE
MORE OF A POPULATION MODEL,
WERE COMMON DISEASES AND THAT
SORT OF THING.
>> THIS IS DON, THE DOCUMENT
SAYS, BUT NOT LIMITED TO, BUT
MOST OF THE BULLET POINTS
INVOLVE ENVIRONMENTAL AND
POLLUTION AND CLIMATE CHANGE.
DO YOU ENVISION AN INCREASED
INTEREST OR USE OF THIS
MECHANISM WITH THOSE AS POINTS
OF EMPHASIS?
>>> SO, THERE HAS BEEN, THERE
WAS A SESSION ON GLOBAL HEALTH
THIS LAST TIME.
THAT -- IT APPEARED THAT THERE
WAS A SIGNIFICANT INTEREST IN
THE COMMUNITY TO MOVE IN THIS
DIRECTION.
THIS IS NOT, IT IS NOT TO SAY
THAT WE HAVE NOT ACCEPTED
APPLICATIONS IN THESE AREAS IN
THE PAST.
BUT, IT'S AN AREA WE'RE
LOOKING TO GROW INTO.
>> YES, I MEAN IT'S WORTH,
ASKING WHETHER YOU WANT TO PUT
IN PRAYER DISEASES AS A POINT
OF EMPHASIS AS WELL.
THAT'S ONE OF THE STUDIES THAT
YOU SHOWED AND THERE'S A LOT
OF PEOPLE IN INDIA AND THERE'S
COMMUNITIES.
SO, YOU CAN ANSWER SOME OF THE
QUESTIONS THAT YOU WOULD HAVE
A VERY DIFFICULT TIME
ANSWERING HERE BECAUSE OF
THOSE NUMBERS OF THOSE DISEASES.
WE'RE GOING TO
CONTINUE WITH OUR OPEN
SESSION.
WE HAVE A COUPLE OF MORE
PRESENTATIONS THAT WE WOULD LIKE TO SHARE WITH YOU.
SO THE FIRST ONE OF THE AFTERNOON IS GOING TO BE BY
NEERAJ AGARWAL WHO WITH ED
CLAYTON, MANAGES THE NEI TRAINING PORTFOLIO.
IT HAS EXPLODED.
NEERAJ AGARWAL IS GOING TO
PRESENT AN UPDATE ON THE NEI'S
PARTICIPATION IN THE LOAN
REPAYMENT PROGRAM.
SO NEERAJ AGARWAL.
>> THANK YOU.
GOOD AFTERNOON.
I HOPE YOU ALL HAD A GREAT LUNCH.
SO I'M HERE TO PRESENT THE
LOAN REPAYMENT REPORT FOR
FISCAL YEAR 2023 MUCH SO THIS
IS PRESENTATION DONE WITH
MYSELF AND ED CLAYTON, YOU MET
HIM IN THE MORNING EARLY.
WHAT HAPPENED?
NOT MOVING.
OH, IT WAS MOVING.
GREAT.
SO, WHAT IS THE PURPOSE OF
LOAN REPAYMENT PROGRAM.
IT IS TO ATTRACT HEALTH
PROFESSIONALS TO DO RESEARCH
AND HOW DO WE DO THAT?
WE PROMISE THEM IF YOU COME
AND DO 50% RESEARCH, YOU DO
RESEARCH WE WILL PAY YOUR
ENGEAL DEBT.
SO ONE OF THE QUALIFYING
LOANS, THE ENGEAL LOANS BACKED
BY THE U.S. GOVERNMENT AND
ENGEAL LOANS FROM U. U.
INSTITUTIONS SUCH AS BANK OF
AMERICA AND SO ON.
SO THE LOANS WHICH YOU HAVE,
THEY DON'T QUALIFY.
SO, WHAT IT DOES, THE
SPECIFICS, WE PAY UP TO
$50,000 DEBT PER-YEAR PLUS THE
ACCRUED IRS TAXES.
SO ONE HAS BEEN A U.S. CITIZEN
OR A U.S. PEAR IN NENT
RESIDENT.
IT'S NOT LIKE IF YOU HAVE
LOANS GOING ON, SOME OF THEM
HAVE BEEN FINANCED FIVE TIMES.
SO, IT IS A MENTORED PROGRAM.
SO YOU NEED TO HAVE A MENTOR
FOR UNDER WHICH YOU ARE GOING
TO BE PERFORMING THAT
RESEARCH.
THE SUPPORT IS NOT REQUIRED,
YOU DON'T HAVE TO HAVE AN "R"
21 OR K-2 3, SO YOU CAN JUST
APPLY FOR LOAN REPAYMENT
PROGRAM IF YOU COMMIT 50% TIME
TOWARDS RESEARCH.
IT'S AN ONLINE APPLICATION.
SMALL SIMPLE APPLICATION.
IT IS PEER REVIEWED AND THE
DEADLINE OF THIS APPLICATION
IS EVERY YEAR, FOR
NOVEMBER 15TH.
SO THIS YEAR THE DEADLINE IS
NOVEMBER 16TH.
NIH, RESEARCH PROGRAM PEOPLE
ARE ALSO ELIGIBLE TO APPLY AND
THE DEADLINE FOR THEM IS
JANUARY TO MARCH EVERY YEAR.
SO, THE TYPE OF, THE PROGRAMS
WE PARTICIPATED, AT NEI, WE
PARTICIPATE IN CLINICAL
RESEARCH, DIVERSITY, PEDIATRIC
RESEARCH, HEALTH DISPART
RIGHTY, AND EMERGING AREAS
CRITICAL TO HUMAN HEALTH.
SO, ONE OF THE NEWEST PROGRAMS
WE ADDED THIS YEAR IS
DIVERSITY L.34, SO IN THIS
CASE, ONE CAN APPLY THIS
PROGRAM IF YOU ARE BELONGING
TO AN UNDER REPRESENTED
MINORITY OR OTHER DIVERSE
GROUP.
SO THIS IS THE DATA, FOR
FISCAL YEAR 2023.
SO, OUR TOTAL, WHAT DO YOU
CALL -- WHAT YOU SEE HERE,
OKAY.
YES, IF YOU SEE HERE, IT WAS
62%.
WE RECEIVED 20 NEW AND 13
RENEW ALWAYS.
26 APPLICATIONS WERE INSTEAD
OF AND WE RENEWED THEM.
OUT OF 13, THOSE WHICH WERE
REPEAT APPLICATIONS.
WHEREAS WE SUPPORTED 6 OUT OF
13, THE NEW APPLICATIONS.
WHEREAS IF YOU SEE THE NIH
DATA IT WAS 69%.
SO THE SUCCESS RATE IS SIMILAR
TO NEI BUT IT IS LOWER THAN
THE PREVIOUS ROUNDS AND THE
REASON FOR THAT I WOULD LIKE
TO EXPLAIN IS THAT THE NEW
APPLICATION IN THE PAST THEY
USED TO ALLOW ME TO PICK UP
FOR TWO YEARS, SO I USED TO
FUND THEM FOR ONE YEAR AND ASK
THEM TO COME BACK AGAIN SO, I
WOULD BE ABLE TO SAVE SOME
MONEY AND PICK UP SOME OTHER
ONES.
SO THIS YEAR THEY DON'T ALLOW
US TO DO THAT.
IF IT IS NEW AND IF THEY ARE
ASKING FOR TWO YEARS, SO WE
HAVE TO PICK UP BOTH YEARS OF
FUND AND NEW APPLICATIONS THEY
USUALLY HAVE HIGH VALUE
ASSOCIATED WITH THEM.
SO THEIR LOANS COULD BE $200
OR MORE.
SO THAT'S HOW I WAS NOT ABLE
TO PICK UP A FEW MORE
APPLICATIONS IN OUR FUNDING
SUCCESS RATE WENT A LITTLE BIT
DOWN.
SO, THIS IS THE DATA A NAY SIS
BY DEGREE.
SO THIS SHOWS HERE, 29% OF
APPLICATIONS OF THE 26 -- I'M
SORRY THIS IS FOR 2008-2023,
SO IF YOU SEE THIS DATA YOU
HAVE 39% OF MDS AND 1 WERE MD
PHD.
THEY HAVE LESSER LOAN BECAUSE
THEIR MD ENGE IS A SUPPORTED
BY OTHER MEANS.
THE OTHERS WERE 9%, AND, 24%.
THE PHDS ALONE WERE 26%. SO
THIS IS THE BIG PAY DOWN WITH
THE DEGREES AND ONLY 1D V.M.
FUNDED FOR THE LOAN REPAYMENT
PROGRAM.
THIS IS TO DO SOME FURTHER
ANALYSIS FROM FISCAL YEAR
2013-32.
THE TOTAL 387 AND THE ALLOWED
APPLICATIONS FUNDED WERE 298.
SO 9 7% OF THE APPLICATIONS
HAVE BEEN FINANCED THE SUCCESS
RATE WAS 77%.
THE UNIQUE NUMBER IS 120.
AND THE TOTAL NUMBER OF THE
RECIPIENTS WHO APPLIED WERE 33
AND THE TOTAL NUMBER WAS 18 SO
55% OF THEM WERE SUCCESSFUL.
SO THIS NUMBER UNIQUE NUMBER
IS REPRESENTING BECAUSE 387,
AS I MENTIONED EARLIER, IF YOU
REMEMBER THAT THE THEY CAN
APPLY MULTIPLE TIMES.
SO ONE PERSON, APPLY THREE
TIMES SO I TOOK THAT NUMBER AS
ONE, NOT AS THREE.
SO THAT'S HOW IT WENT TO 120.
SO THANK YOU AND I WISH TO
THANK ED FOR HIS VERY NICE
ANALYSIS DATA WHICH I
PRESENTED HERE AND I
APPRECIATE AND I IF A SOME
QUESTIONS IF YOU HAVE THEM.
>> THANK YOU.
>> WE HAVE A FEW MACHINES FOR
QUESTIONS.
ANY QUESTIONS?
I'M SORRY TO PEOPLE A ZOOM.
THE SLIDES WERE NOT SHARED.
A LITTLE TECHNICAL GLITCH
THERE.
BUT HAPPY TO SEND THEM TO
ANYBODY WHO REQUESTS THEM.
>> THANK YOU SO MUCH.
MAYBE I MISSED IT.
>> THIS IS TOM GARDNER ON
ZOOM.
LATE TO SHOW.
DO YOU THINK THAT YOU'RE
GETTING IS APPLICATIONS AS YOU
LIKE?
DO YOU THINK IT IS UNDER
UTILITZED?
>>> THANK YOU, TOM.
THE NUMBER OF APPLICATIONS FOR
THE LAST FIVE YEARS OR SO WE
ARE RANGING AROUND 30
APPLICATIONS.
WE USED TO GET IN THE 40'S.
BUT THAT NUMBER HAS COME DOWN
FOR SOME REASONS.
ONE OF THE REASONS I WAS GIVEN
BY ONE OF THE COUNCILMEMBERS,
A COUPLE OF YEARS AGO WAS THAT
THEY ARE TRAINING -- THEY HAVE
BEEN SUPPORTED BY THE MEDICAL
SCHOOLS OR WHEN THEY ARE DOING
THEIR RESIDENCY SO THEY ARE
ABLE TO PICK UP THEIR LOANS.
SO I'M NOT SURE.
YOU MAY BE ABLE TO ANSWER THAT
IF YOU ARE DOING THAT AT THE
UNIVERSITY OF MICHIGAN.
BUT THE NUMBER IS CONSISTENT
NOW, WE'RE GETTING 30
APPLICATIONS.
>> YEA I DON'T HAVE ANY NEW
INSIGHTS EXCEPT THE PEOPLE WHO
I KNOW WHO HAVE BEEN
SUCCESSFUL HAVE FOUND IT VERY
HELPFUL AND IT'S NOT AT HIGH
BAR.
THANK YOU VERY MUCH FOR DOING
THAT.
>> THANK YOU.
IT'S REALLY A GREAT PROGRAM.
THANK SO MUCH FOR THAT.
DY MISS THIS OR DID I
MISUNDERSTANDING THAT YOU DO
NOT SUPPORT PEOPLE DOING
BASIC, YOU HAVE CLINICAL AND
DISPART RIGHTY, BUT BASIC?
>>> NO, WE DO SUPPORT BASIC
RESEARCH.
SO CLINICAL RESEARCH WILL
COMPRISE OF THAT AND ONE OF
THE STIPULATIONS IS THAT YOU
SHOULD BE USING SOME HUMAN
TISSUE, NOT HUMAN SUBJECTS.
THEN THAT FALLS INTO CLINICAL
CATEGORY.
AND PEDIATRIC RESEARCH HAS
EVERYTHING EXCEPT THAT YOU ARE
DEALING WITH SOME OF THE
DISEASES LIKE EARLY ON SET OF
GLAUCOMA AND DIABETES.
SO, AND THE HEALTH DISPART
RIGHTY, YOU KNOW, SO,
BASICALLY, RESEARCH IS A
LITTLE TRICKY ABOUT IT.
>> THANK YOU.
>> YES.
>>> DOES IT PAY UP TO FULL
AMOUNT OF SOME OF THESE LOANS
OR IS THERE ONLY A CERTAIN
PERCENTAGE
>>> NO, WE PAY THE FULL DEBT.
AND THAT INCLUDES
UNDERGRADUATE LOANS BY THE WAY
FOR YOUR ENGE.
SO AS I SAID, PEOPLE APPLY
MULTIPLE TIMES UNTIL THEIR
DEBT COMES TO BE ZERO.
AND I MET SOMEBODY LAST WEEK
AT STANFORD AND HE WAS
THANKING ME.
HE SAID, YOU WON'T SEE MY
APPLICATION ANY MORE OF THE
I'M DONE.
[LAUGHTER]
>> I WANT TO ECHO TOM'S
THOUGHT.
THANK YOU THIS, A GREAT, GREAT
PROGRAM.
IT REALLY HELPS OUR
SCIENTISTS, TO CONTINUE TO
STAY IN OUR FIELD AND
CONTRIBUTE.
I REALLY HOPE THEY COULDN'T TO
BE SUPPORTED.
>> THANK YOU.
I AM NOT SURE, OUR NEXT SPEAK
SER HERE YET.
SO, TALK AMONGST YOURSELVES
AND I'LL BE RIGHT BACK
SHE'LL BE WITH US MOMENTARILY.
>> SO WE DO HAVE NONI BYRNES
HERE AND I'LL INTRODUCE HER IN
A SECOND.
>> THANK YOU FOR JOINING US.
WE'RE AHEAD OF SCHEDULE RIGHT
NOW.
SO, IT'S, THIS IS A REAL
PLEASURE FOR US TO HAVE YOU
VISIT.
SO, LET ME INTRODUCE NONI
BYRNES.
SHE IS THE DIRECTOR OF THE
CENTER FOR SCIENTIFIC REVIEW.
CSR.
WHAT THEY DO IS THEY REVIEW
THE MAJORITY OF GRANTS THAT
ARE SUBMITTED TO NIH.
IT'S OVER 75% OF THE GRANTS
GET REVIEWED AT C. SR.
I'LL PAUSE HERE AND GIVE YOU A
CHANCE.
BECAUSE I DIDN'T REALIZE -- EDUN
>> THIS IS OUR THIRD.
YEA AND WAS IT'S, NO WE REALLY
LOVED HAVING THE GROUP IN
PERSON.
>> NONI BYRNES IS THE DIRECTOR
OF CENTER FOR SCIENTIFIC
REVIEW.
THEY REVIEW OVER 95% OF THE
GRANTS THAT ARE SUBMITTED TO
NIH.
THERE'S THIS SAYING THAT
NOTHING IS PERFECT.
BUT, ONE THING THAT I HAVE
BEEN TRULY PROUD OF IS THAT I
HEARD CSR AND THE GRANT REVIEW
PROCESS AM TIMES, REFERRED TO
AS THE GOLD STANDARD OF GRANT
REVIEW PROCESSES AROUND THE
WORLD.
AND ONE THING, ANOTHER THING
THAT I HAVE BEEN IMPRESSED IS
THAT NONI BYRNES AND HER CREW,
DESPITE THAT, THEY'RE ALWAYS
TRYING TO MAKE A GOOD PROCESS
BETTER.
SO, REALLY, JUST A LITTLE BIT
OF BACKGROUND ABOUT NONI
BYRNES IS THAT SHE'S A PHD IN
CHEMISTRY AND HAD WORKED IN
THE INDUSTRY AND HAS HAD A
LONG CAREER HERE AT CSR AND
HAS BEEN THE DIRECTOR HERE.
SHE'S GOING TO TALK ABOUT CSR
'S INITIATIVESES TO STRENGTHEN
PEER REVIEW AND GIVE AN
UPDATE.
SO NONI BYRNES, WELCOME.
>> GREAT. THANKS VERY MUCH
MIKE AND KATHLEEN, FOR THE
INVITATION.
SO, LET ME GET STARTED.
TRY THIS WAY.
>> YOU BE USE THE SPACE BAR.
>> SPACE IS NOT WORKING AND
DOWN IS NOT WORKING.
THANK YOU.
>> OKAY.
SO I'LL JUST GIVE A QUICK
OVERVIEW OF WHAT IT IS WE DO
AND THE SCOPE OF OPERATIONS
THAT WE HAVE.
OUR MISSION OF COURSE IS TO
VERY SINGULAR AND IDENTIFY THE
MOST PROMISING SCIENCE FOR NIH
SUPPORT.
WE DO THAT BY ENSURING THAT
NIH GRANT APPLICATIONS RECEIVE
TIMELY REVIEWS THAT ARE FREE
FROM INAPPROPRIATE
INFLUENCESES.
>> IN 2023 WE REVIEWED ABOUT
60,000 APPLICATIONS AND THAT'S
A LITTLE OVER THREE QUARTERS
OF ALL APPLICATIONS THAT WERE
SUBMITTED TO THE NIH.
A VAST MAJORITY ARE DONE BY
CSR AND SMALL BUSINESS, AND N.
R. STATE FELLOWSHIPS AND WE DO
THIS WITH THE ASSISTANCE OF
270 REVIEW OFFICERS, 19,000
REVIEWERS IN OVER 1200
MEETINGS EVERY YEAR.
SO, PEOPLE THINK OF C. -- CSR,
AND THEY THINK OF STANDING
GOING MECHANISMS.
WE DO THAT.
BUT WE ALSO DO A VERY LARGE
NUMBER OF SPECIAL EMPHASIS
PANELS.
BECAUSE WE'RE ASKED TO TAKE ON
THESE HIGH PROFILE REVIEWS.
LAST YEAR, THAT'S ARE JUST
SOME EXAMPLES.
BUT IN THE LAST FISCAL YEAR WE
HANDLED 161 SPECIAL
INITIATIVES FOR NIH.
SO SINCE 2019 WE'RE HAD THIS
FRAMEWORK THAT WE BASE ALL OF
OUR ACTIONS AND INITIATIVES
ON.
THE BROADER GOAL OF THIS
FRAMEWORK IS TO EPITOMIZE THE
PIER REVIEW PROCESS AND AIM
TOWARDS A HIGH QUALITY
OUTPUT.
IT'S IN THREE DOMAINS.
SO ONE IS STUDY SECONDS.
HOW ARE STUDY SECONDS
STRUCTURED.
AND, ARE THEY ADAPTING TO
EMERGING AREAS AND ARE THEY
LARGE ENOUGH TO BE
COMPETITIVE.
THAT MATTERS A LOT.
YOU COULD HAVE WEAK AREAS OF
SCIENCE, AND 10% STILL GETS
AWARDED OR STRONG AREAS OF
SCIENCE, ONLY 10% GETS
AWARDED.
>> EVEN IF YOU HAVE A
SCIENTIFIC ONE, THERE ARE
OTHER PARTS THAT IMPACT T ONE
IS THE ACTUAL TIST REVIEWERS.
NOW, WHO WE RECRUIT AND, HOW
BROAD IS THE POOL OF REVIEWERS
AND HOW WE ASSESS REVIEWERS.
SO THAT'S ANOTHER PART OF THE
DOMAIN THAT FOCUS' QUALITY OF
REVIEW. BUT THEN EVEN IF YOU
HAVE NICE STUDY SECTIONS AND
VERY STRONG REVIEWERS, THE
PART OF THE PROCESS THAT CAN
IMPACT THE OUTCOMES.
THAT IS YOU KNOW, WHETHER THE
PROCESS IS CONFIDENTIAL,
WHETHER PEOPLE FEEL FREE TO
SPEAK UP AND KNOW THAT IT'S
CONFIDENTIAL.
BIAS IN THE PROCESS ITSELF.
HOW WE'RE ASSIGNING
APPLICATIONS TO STUDY SECTIONS
AND HOW OUR CRITERIA AND
SCORING SYSTEM WORK.
ALL OF THOSE IMPACT THE OUTPUT
OF PEER REVIEW.
THIS FRAMEWORK IS ALSO BASED
ON A NUMBER OF OPERATING
PRINCIPLES AND I HOPE AS I GO
THROUGH THIS TALK YOU WILL SEE
WE'RE ATTEMPTING TO OPERATE
WITH THE HIGHEST LEVEL OF
TRANSPARENCY, WE'RE USING DATA
TO DRIVE OUR DECISIONS.
WE ENGAGE GOING WITH THE
COMMUNITY ALMOST IN EVERYTHING
WE DO.
BUT OF COURSE THE MOST
IMPORTANT PART IS THE PEOPLE
WHO ACTUALLY DO ALL OF THIS
WORK WHICH IS OUR STAFF.
SO WE HAVE INVESTED A LOT IN
DEVELOPING STAFF.
WE HAVE A NEW OFFICE THAT
FOCUSES ON STAFF DEVELOPMENT.
SO, I'M GOING, NOT GOING TO
TOUCH ON EVERYTHING THAT WE'RE
DOING.
BUT SEVERAL TOPICS.
ONE IS THE INQUIR PROCESS AND
THAT'S A STUDY SECTION
RESTRUCTURING PROCESS.
THE OTHER IS CHANGES TO REVIEW
CRAWFORD RESEARCH PROJECT
GRANTS AND ALSO TO FELLOWSHIP
APPLICATION REVIEWS.
AND THEN SOME OF OUR
INITIATIVES IN PROMOTING THE
FAIRNESS AND DIVERSIGUYING OUR
REVIEW COMMITTEES.
LET ME START WITH INQUIRE.
SO INQUIRE IS, WELL, IT IS
EVALUATING PANEL QUALITY AND
REVIEW.
SO, AS I LIKE TO SAY THIS IS
ONE OF THOSE NIH ACRONYMS THAT
IS RETROFITTED.
WE HAVE OUR OWN.
IT'S EVALUATE GOING PANEL
QUALITY AND REVIEW.
IT'S A SYSTEMATIC PROCESS
THAT'S MEANT TO BE CONTINUOUS
AND EVALUATE 20% OF THE STUDY
SECTIONS EVERY YEAR TO ENSURE
THAT THEY GET AT EXTERNAL LOOK
EVERY FIVE YEARS.
IT'S DONE IN TWO STAGES, SO
STAGE ONE INCLUDES AN EXTERNAL
EVALUATION PANEL.
HERE WE'RE LOOKING FOR BROAD
EXPERTS IN THE FIELD.
WE'RE TRYING TO AVOID PEOPLE
WHO HAVE A VESTED INTEREST IN
THE EXISTENCE OF ONE
COMMITTEE.
BECAUSE WE GET ADVOCACY.
SO WE TRY VERY HARD TO GET
BROAD INPUT.
WE PROVIDE THIS EXTERNAL PANEL
WITH A NUMBER OF DATA ITEMS.
PUBLICATION DATA FROM PRIOR
FUNDED GRANTS -- "S.I."
OUTCOME DATA.
AND THEN WE ALLOW THEM TO DO
ANYTHING THEY WANT.
THEY CAN RECOMMEND CHANGES.
THESE ARE STILL
RECOMMENDATIONS BUT THEY CAN
SUNSET STUDY SECTIONS AND MOVE
AREAS OR CREATE NEW ONES.
THIS IS FOLLOWED BY A PROCESS
EVALUATION PANEL.
HERE'S WHERE WE EVALUATE THE
FUNCTION OF THE STUDY
SECTION.
IT CAN BE NICELY STRUCTURED
BUT HOW WELL IT DOES, THE
QUALITY OF THE REVIEWERS, THE
STRENGTH OF THE DISCUSSIONS,
AND SCORING DATA, SO HERE,
THIS IS AN INTERNAL PANEL AND
I DON'T MEAN CSR, I MEAN NIH,
AND, AGAIN WE TRY TO NOT HAVE
INDIVIDUAL SROS OFFICERS WHO
MIGHT HAVE A VESTED INTEREST.
BUT A LEVEL OR TWO HIGHER
ADVISE US ON THIS.
WE PROVIDE THEM WITH DATA AND
ASK THEM TO PROVIDE US WITH
RECOMMENDATIONS.
THE WAY WE GET PROGRAM
FEEDBACK IS THROUGH SURVE
SURVEYS.
EVERY TIME IT GOES THROUGH
THIS PROCESS WE REACH OUT TO
PROGRAM OFFICERS AND GET THEIR
SURVEY DATA ON HOW THEY FEEL
THE EXPERTISE IS.
WE ALSO HAVE STUDY SECTION
SITE VISITS BY DISCONNECTED
PARTIES BECAUSE A LOT OCCURS
AT THE MEETING THAT CAN DRIVE
OUTCOMES.
SO WE HAVE PEOPLE WHO ARE NOT
IN THE LINE OF AUTHORITY OF
THE SRO, GO AND FILL OUT THE
FORM AND ALL OF THIS DATA GOES
TO SECONDARY PROCESS PANEL.
AND THEN THE FINAL STAGE IS
GOING IN FRONT OF THE ADVISORY
COUNCIL WHERE ALL OF THIS IS
PRESENTED AND THEY HAVE TO
APPROVE IT.
THE WHOLE PROCESS IS OVERSEEN
BOY OUR SCIENTIFIC DIRECTORS.
I WON'T GO THROUGH ALL OF
THIS, THERE'S A LOT OF STEPS
INVOLVED AFTER OUR COUNCIL
APPROVES THE CHANGES.
WE DO MOCK SORTS, TO MAKE SURE
THEY ARE VIABLE AND ENOUGH
APPLICATIONS GO IN THERE.
WE REFINE THE GUIDELINES,
OVERLAP STATEMENTS AND CLEAR
TO COMMUNITY AND TO OUR
STAFF.
AND THEN WE PUBLISH THOSE
GUIDELINES AND MOVE
EXPERTISE.
THAT ENTIRE PROCESS TAKES
REALLY ABOUT A YEAR-AND-A-HALF
FROM THE TIME THE FIRST
EXTERNAL PANEL MEETS TO WHEN
THE STUDY SECTIONS HOLDS THEIR
FIRST MEETINGS.
SO THUS FAR WE HAVE DONE 13
SCIENTIFIC CLUSTERS.
152 STUDY SECTIONS THAT ARE
EITHER COMPLETED OR IN
PROGRESS.
THESE ARE JUST THE BROADER
AREAS THAT WE'RE DOING.
THE ONES WITH SHADED ARE THE
ONES THAT ARE IN PROGRESS.
SO WHAT WE FOUND IS THAT DOING
THIS WAY ACTUALLY YIELDS QUITE
SUBSTANTIVE CHANGES.
PRIOR ITER RAISINGS, THAT WE
HAVE DONE HAVE NOT YIELDED A
LOT OF CHANGES, A LOT CAME
INTERNALLY, JUST REVIEW STAFF,
PROGRAM STAFF TALKING
TOGETHER.
THIS IS A WAY ARE TO THE
EXTERNAL COMMUNITY TO WEIGHING
IN AS TO WHERE THE SCIENCE IS
AND ADVICE US IT HAS RESULTED
IN ELIMINATION OF SMALLER
PANELS.
WE REFRESH GUIDELINES AND
CREATED HAD A LOT OF NEW STUDY
SECTIONS AND CREATED MORE
EMERGING SCIENCE.
SO JUST AS A QUICK EXAMPLE,
THERE WAS THIS GAP AREA IN
THERAPEUTICS, LATE STAGE DRUG
DISCOVERY WAS SEEN AS A GAP
AREA.
WE CREATED ADD STUDY SECTION
AND WITHIN AROUND, WE HAD 80
APPLICATION.
THERE'S A REAL NEED.
IT'S TOO BIG.
WE HAVE TO FIGURE IT OUT.
WE HAVE MIDDLE BETWEEN INQUIRE
THE FIVE-YEAR PERIOD
MANAGEMENT PROCESSES AND
EVALUATION THAT'S WE DO.
SOCIAL DETERMINANTS OF
HEALTH.
THERE WAS A LOT OF DISCUSSION
REGARDING IT.
AND THE THOUGHT WAS THAT
INSTEAD OF HAVING IT ALL IN
ONE STUDY SECTION, IT REALLY
EFFECTS AM DIFFERENT AREAS OF
SCIENCE AND COMMUNITIES.
SO THAT'S A EXAMPLE OF
SOMETHING WHERE THE GUIDELINES
HAVE BEEN INCORPORATED INTO
DIFFERENT AREAS.
MOBILE HEALTH TECHNOLOGY IS A
GROWTH AREA.
CANCER THERAPY WAS A GROWTH
AREA, WE HAVE TWO STUDY
SECTIONS AND WE HAVE A THIRD
ONE.
BECAUSE THERE WAS SUCH A NEED.
SO SWITCHING GEARS TO LOOKING
AT THE RESEARCH PROJECT GRANT
APPLICATIONS.
SO THIS IS PART OF THE PROCESS
CHANGES THAT WE'RE
APPROACHING.
SO AGAIN, OUR BROADER GOAL WAS
TO EPITOMIZE THE
IDENTIFICATION OF THE MOST
PROMISING RESEARCH, NO THE
MOST PROMISING PERSON OR
INSTITUTION BUT THE RESEARCH
PROJECT.
THAT'S WHAT THEY ARE, GRANTS.
SO A COUPLE WAYS THE FIRST
WAY, AND THIS IS ENTIRELY, WE
DID THIS IN CONJUNCTION WITH
THE COMMUNITY.
WAS THIS CONCERN ABOUT
ADMINISTRATIVE AND POLICY
COMPLIANCE ITEMS THAT HAVE
BEEN ADDED TO THE PEER O PEER
REVIEW.
WE BRING REALLY STRONG
SCIENTISTS IN AND WE GIVE THEM
THESE LITTLE CHECK BOXES THAT
THEY HAVE TO FILL OUT.
AND I HEARD A LOT OF
FRUSTRATION.
BUT OUR STAFF DID.
SO ONE OF THE MAJOR GOALS WAS
TO TAKE AWAY SOME OF THOSE
POLICY COMPLIANCE ITEMS, SO
THAT ALLOWS THE PEER REVIEWERS
TO FOCUS ON SCIENCE.
THE OTHER CONCERN IS THE ROLE
OF REPUTATIONAL BIAS IN PEER
REVIEW AND THAT COMES IN WITH
THE INVESTIGATOR AND
ENVIRONMENT.
IN TRYING TO MITIGATE THE
INFLUENCE OF THAT
INSTITUTIONAL OF PERSONAL
REPUTATION ON THE EVALUATION
OF THE PROJECT.
LET ME START WITH THE
BOTTOM-LINE OVERVIEW OF THE
CHANGES THAT ARE COMING UP AND
WE'LL BE ANNOUNCING THESE
LATER THIS MONTH.
SO FIRST OF ALL, THE CURRENT
FIVE REVIEW CRITERIA,
SIGNIFICANTS INNOVATION,
APPROACH, INVESTIGATOR AND
ENVIRONMENT ARE BEING
RESTRUCTURE SHOOFERD INTO
THREE FACTORS.
IF YOU THINK ABOUT IT, FACTOR
ONE IS, SHOULD IT BE DONE.
>> FACTOR TWO, CAN IT BE DONE
AND THREE, WILL IT BE DONE.
>> THE IMPORTANCE OF THE
RESEARCH.
ONE OF THE THINGS WE HEARD
FROM THE COMMUNITY IS THEY
WERE CONFUSED ABOUT
INNOVATION.
ANY WHO HAVE SERVED ON PANELS,
IS IT CONCEPTUAL?
TECHNICAL.
DOES IT MATTER?
DOES IT HAVE TO BE INNOVATIVE?
SO THIS ALLOWS THE REVIEWER TO
GIVE ONE SCORE AND WEIGHING
WHAT THEY THINK IS THE MOST
IMPORTANT DRIVER IN MAKING IT
ARE THE CLUE.
IT COULD BE NOT INNOVATIVE AND
STILL GET A GOOD SCORE.
>> RIGOROUS, IMPORTANCE,
FEASIBILITY ARE SCORED.
AND THEN THERE'S FACTOR THREE
WHICH HAS BEEN RENAMED
EXPERTISE AND RESOURCE THAT'S
WHAT WE'RE ASKING THEM TO
EVALUATE.
NOT THE PERSON OR HOW FAMOUS,
AND NOW THE INSTITUTION BUT IS
THE EXPERTISE THERE TO CARRY
OUT THE RESEARCH SUCCESSFULLY?
THAT ONE IS NOT SCORED.
SO ONE OF THE ISSUES WITH
SCORING IS THAT YOU GIVE NINE
BINS TO SOMEONE AND BIAS CAN
CREEP IN.
WE SAW IT HAPPEN.
BUT IF YOU ARE HARVARD, YOU'RE
A ONE.
IF YOU ARE FROM AN "H" B.C.U.
YOU HAVE EVERY RESOURCE YOU
MIGHT BE A THREE.
IT'S NOT BAD.
IT'S NOT AT ONE.
SIMILAR THINGS WITH
INVESTIGATOR, WELL-KNOWN
INVESTIGATOR VERSUS SOMEONE
WHO IS LESS KNOWN.
SO, HERE IT'S A BINARY CHOICE
WHICH IS EITHER THEY HAVE THE
EXPERTISE AND RESOURCES OR
THERE'S A GAP.
IF THERE'S A GAP WE WANT TO
KNOW WHAT IT IS.
SO THEY MUST PUT UP OR NOT.
THEY MUST WRITE OUT WHAT THE
GAP IS.
AND THAT SHOULD THEN EFFECT
OVERALL IMPACT SCORE. IF
THERE'S A PROBLEM IT SHOULD
AFFECT THE SCORE.
FOR ADDITIONAL CRITERIA, A
NUMBER OF THESE ADDITIONAL
CRITERIA ARE NOT INDIVIDUALLY
SCORED NOW.
THEY CAN EFFECT THE OVERALL
IMPACT SCORE.
MOST OF THIS IS NOT CHANGING,
WITH THE WITH THE EXCEPTION OF
THE CLINICAL TRIALS IN.
WE HAD ALL OF THESE ADDITIONAL
REVIEW CONSIDERATIONS WHICH
HAD NO BEARING ON THE OVERALL
MERIT.
THOSE ARE BEING REMOVED
BECAUSE WE DON'T NEED ALL OF
YOU TO TELL US ABOUT THAT. WE
CAN DO IT OURSELVES.
THE ONE CHANGE THAT WAS
RECOMMENDED AND THIS IS FOR
HUMAN SUBJECTS RESEARCH AND
CLINICAL TRIALS IS TO TAKE THE
INCLUSIONS AND PUT THEM IN
FACTOR TWO, BECAUSE THEY'RE AN
AFTERTHOUGHT.
WHEREAS REALLY HAVING
INCLUSIVE POPULATION IS
CRITICAL TO RIGOROF THE WORK
YOU'RE PROPOSING.
SO THAT REYES ITS PROFILE
EXPUTS IT UNDER THE SCORED
FACTOR TOO.
SO, JUST A LITTLE BIT ON THE
PROCESS, WE GOT AT TREMENDOUS
AMOUNT OF COMMUNITY INPUT.
WE STARTED IT WITH BLOGS AND
WHEN YOU ASK PEOPLE HOW SHOULD
WE CHANGE PEER REVIEWS?
EVERYONE HAS AN OPINION.
THEY WERE GOOD. THEY WERE
VERY THOUGHTFUL.
WE DID A CONTENT ANALYSIS.
WE ENGAGED WITH THE CAN TERNAL
COMMUNITY, NOT JUST THAT WAY
BUT ALSO FORMALLY, AND WE HAVE
TWO DIFFERENT WORKING GROUPS
THAT FOCUSED ON NONCLINICAL
TRIALS, 80%, AND CLINICAL
TRIALS.
WE PROVIDED THEM WITH OUR
REGULATORY GUARDRAILS.
WE MUST HAVE THE FIVE REVIEWS,
THAT COULD BE CHANGED BUT IT
NEEDS TO GO TO CONGRESS AND
NOBODY WANTSES TO DO IT.
BECAUSE THEN CONGRESS OPENS UP
EVERYTHING.
SO, BUT, THE GUARDRAILS ARE
JUST THAT.
USE THE FIVE CRITERIA HOW YOU
USE THEM IS UP TO AGENCY.
THAT'S WHAT THEY DID IN TUM IN
COMING UP WITH A FACTOR
SYSTEM.
AND THEN WE ADD FULL COUNCIL
APPROVAL AND THEN PUBLISHED
THE REPORT.
SO THAT ALL HAPPENED IN THE
MIDDLE OF THE PANDEMIC.
THIS WORKING GROUP WORKED VERY
HARD IN VIRTUAL MEETINGS,
WORKING THROUGH THIS AND IF A
TERRIFIC JOB.
IT THEN MOVED TO THE NIH WHERE
A HIGH LEVEL WORKING GROUP
SPENT TIME DOING MODIFICATIONS
AND MAKING THINGS MORE CLEAR
AND THEN THAT FRAMEWORK WAS
THEN APPROVED BY THE NIH
LEADERSHIP.
WE ALSO THEN, WHEN WE HAD IT
DEVELOPED, WE PUT IT OUT FOR
BROAD PUBLIC COMMENT THROUGH
AN "R" F.I., AND WE ACTUALLY
GOT MOSTLY SUPPORTIVE
RESPONSES.
THE REPORT IS POSTED NOW.
SO THIS IS GOING TO BE
IMPLEMENTED BEGINNING WITH
APPLICATIONS THAT ARE RECEIVED
IN JANUARY 2025 AND WILL BE
REVIEWED IN SUMMER 25 FOR
OCTOBER 25 FUNDING.
SO WHAT ARE THE NEXT STEPS?
WELL THE NEXT STEPS WE HAVE A
LOT TO DO BETWEEN NOW AND
JANUARY 25.
SEEMS LIKE A LONG TIME BUT IT
IS A LOT OF CHANGES.
WE HAVE TO HAVE SYSTEMS
CHANGES AND TRAINING, AND WE
HAVE.
THEY'RE GOING TO BE A GUIDE
NOTICE COMING OUT SOON, A
PUBLIC WEB FAR AND STAFF WEB
BEEN FAR AND THEN REFINE THE
APPLICATIONS AND CHANGE E.R.A.
SYSTEMS AND DO A LOT OF
SOCIALIZING OF THIS CHANGE TO
COMMUNITIES TO OUR REVIEWERS
AND OUR CHAIRS AND BRIAN, IS
THE CO-CHAIR OF THE
IMPLEMENTATION EXECUTIVE
COMMITTEE THAT IS HANDLING
THIS AND THERE'S A LOT WHICH
I'M SURE YOU'LL HEAR MUCH MORE
ABOUT OVER THE NEXT MONTH OR
TWO.
I WANT TO ACKNOWLEDGE OUR
WORKING GROUPS ON SIMPLIFYING
THE REVIEW.
THEY WORKED HARD THROUGH THE
PANDEMIC AND CAME UP WITH AN
EXCELLENT SET OF
RECOMMENDATIONS.
JUST SWITCHING GEARS TO
FELLOWSHIP.
SO AGAIN HERE THE BROADER GOAL
IS WE WANT TO MAKE SURE THAT
NIH PEER REVIEW IS IDENTIFYING
THE STRONGEST MOST PROMISING
RESEARCHERS OF THE NEXT
GENERATION.
SO OVER THE YEARS AGAIN WE
HEARD CONCERNS FROM THE
COMMUNITY SIMILAR TO R.O.1S
WHICH IS THE REPBUT TASTING
SEEMS TO IMPACT WHO GETS
THROUGH AND ALSO SENIORITY OF
THE SYSTEM.
SO WE ALSO FORMED A WORKING
GROUP FOR THIS AND THE WORKING
GROUP ASKED US FOR A LOT OF
DATA.
THEY SAID CAN YOU ANALYZE DATE
IF A AND SEND US SOME OF THIS
INFORMATION.
THE DATA CONFIRMED THOSE SORT
OF CONCERNS THAT WE HEARD
WHICH IS IT'S A SMALL NUMBER
OF APPLICATIONS THAT SUBMIT A
VAST MAJORITY OF THE
FELLOWSHIP APPLICATIONS.
THOSE THAT DO THAT, DO REALLY
MUCH BETTER IN REVIEW THAN
THOSE THAT JUST SUBMIT A FEW.
THEY'RE NOT USED TO
SUBMITTING.
THAT REVIEW OUTCOMES ARE
DIRECTLY RELATED TO THE RANK
OF THE SPONSOR.
SO I GAVE YOU THE
BOTTOM-LINE.
BUT LET ME SHOW YOU THE DATA
REALLY QUICKLY.
LET'S NOT GO THROUGH THE WHOLE
THING.
BUT LET'S LOOK AT THIS.
SO WE JUST LOOKED AT 6,000
APPLICATIONS IN THREE COUNCIL
ROUNDS.
15 INSTITUTIONS SUBMITTED 100
APPRAISALS COST ARE OR MORE
DURING THAT PERIOD.
106 SUBMITTED 1-2
APPLICATIONS.
AND EVERYTHING IN THE MIDDLE.
YOU CAN SEE THE SKEWED PICTURE
WE HAVE HERE.
SO THIS IS THE OUTCOME AND, OF
COURSE, AS EXPECTED THOSE THAT
SUBMIT A LOT OF APPLICATIONS
TEND TO HAVE HIGH IMPACT, AND
THOSE THAT SUBMIT FEW, HAVE
FEWER AND.
SO ACADEMICS, THIS IS A BUSY
SLIDE.
LOOK AT THE FIRST FOUR.
SO THIS IS THE ACADEMIC RANK
OF THE SPONSOR.
IF YOU ARE AN ASSIST TANS
PROFESSOR, 1515% THEY ARE NOT
SCORED, AND, FOR FULL
PROFESSORS IT'S 39.9 AND 39.1,
THE VAST MAJORITY COME FROM
FULL PROFESSORS AND THEY DON'T
DO WELL, THEY ARE LESS LIKELY
TO SUBMIT.
THERE'S THIS OTHER WE WERE
CURIOUS ABOUT THAT.
WE FOUND OUT THEY ARE DEANS
AND PREVIEWS, AND THEY ARE
SOMETHING MORE.
SO, TWO RECOMMENDATIONS THAT
CAME OUT OF THE WORKING UP
GROW.
ONE WAS TO CHANGE THE REVIEW
CRITERIA TO FOCUS THIS ON THE
ATTENTION OF THE EVERY
APPLICANT AND THE STRENGTH OF
THE SCIENCE AND THE PLAN.
ON THE LEFT YOU SEE THE
CURRENT REVIEW CRITERIA.
ON THE RIGHT YOU SEE THE
PROPOSED REVIEW CRITERIA.
THESE WILL UNDER GO SOME
CHANGE ON THE RIGHT BECAUSE
THE COMMITTEE IS WORKING
THROUGH SLIGHT REVISIONS TO
THE TITLES.
BUT, OVERALL THE GOAL HERE IS
TO ALLOW THE APPLICANT TO
PRESENT HIM OR HERSELF WITH A
VERY SPECIFIC TARGETED
TRAINING NEEDS AND HAVE THE
SCIENCE AND RESEARCH TRAINING
PLAN BE TARGETED FOR THAT
APPLICANT AND NOT HAVE IT BE A
FACTORY THAT WE SEE THAT'S
MUCH MORE LIKELY TO HAPPEN
WITH MORE SENIOR SPONSORS.
THE SECOND RECOMMENDATION IS
TO REVISE THE APPLICATION AND
THIS IS MORE TO MAP ONTO THE
REVIEW CRITERIA.
THERE'S NO CHANGE TO RESEARCH
CHANGING PLAN OR THE SCIENCE,
WE EXPECT A STRONG PROJECT.
TRAINING THE INDIVIDUAL, WE
WANT RESPONSIBLE CONDUCT OF
RESEARCH, NOTHING CHANGES
THERE.
WE -- BUT SOME OF THE SECTIONS
IN THE APPLICATI
APPLICATIONS, THE SPONSORS,
LETTERS OF SUPPORT HAVE BEEN
CHANGED TO ALIGN WITH THE NEW
REVIEW CRITERIA.
THE NEW CHANGE IS ELIMINATION
OF GRADES.
THIS WAS SUPPORTED BY THE
COMMUNITY, BY OUR COUNCIL AND
THAT IS BECAUSE UNDER GRADUATE
GRADES ARE NOT A GOOD
REFLECTION OF SUCCESS.
MORE OTHER IF YOU PUT GRADES
IN FRONT OF REVIEWERS, YOU PUT
A B-PLUS, AND A B, ONE IS
BETTER THAN THE OTHERS.
BUT IT'S VERY SILLY.
SO THIS IS REALLY TO FOCUS
REVIEWERS ON WHAT MATTERS TO
MAKE A GOOD STRONG SCIENTIST.
MUCH MORE TARGETED LETTERS OF
SUPPORT.
THERE'S A WHOLE LOT OF DETAIL
HERE.
THE REPORT IS PUBLISHED AND
THIS WILL GET ROLLED OUT,
HOPEFULLY LATER THIS YEAR BUT
SOON.
THAT ONE WENT THROUGH A
SIMILAR COMMUNITY INPUT
PROCESS WITH WORKING GROUPS
AND BLOGS AND DATA AND THE
FULL COUNCIL APPROVAL.
IN THIS CASE IT WAS VERY
LITTLE MODIFICATION BECAUSE
THE NIH LEADERSHIP TOOK THE
RECOMMENDATION QUESTIONS
IMPLEMINUTED THEM.
WE DID HAVE AN "R" F.I.
IT SAYS REPORT TO BE
PUBLISHED.
IT HAS BEEN PUBLISHED.
MAJORITY ARE SUPPORTIVE.
SO THIS IS A HOPE MORE THAN AN
ACTUAL IMPLEMENTATION DATE.
WE ARE HOPING THAT WE CAN DO
THIS FOR THE SAME TIME-FRAME,
BUT WE'RE NOT SURE YET.
IT WILL DEPEND ON HOW MUCH
MODIFICATION HAPPENS.
>> AGAIN I WANT TO THANK, JUST
THIS TERRIFIC GROUP OF
INVESTIGATORS, AT ALL
DIFFERENT STAGES AND NIH STAFF
WHO WERE INVOLVED IN DEVELOP
GOING THESE RECOMMENDATIONS.
SO, WHEN I'M ASKED TO COME AND
TALK TO COMPOUND SILLS, THE
INITIAL AND IS COMING AND TALK
ABOUT THE PIER REVIEW CHANGES,
THE CRITERIA CHANGES.
I NO LONGER JUST TAKE ON THOSE
ASSIGNMENTS, BECAUSE THEN THE
QUESTIONS ARE, WHAT ELSE ARE
YOU DOING?
THIS ISN'T GOING TO CHANGE.
JUST CHANGE THE CRITERIA IS
NOT GOING TO CHANGE FAIRNESS.
SO NOW I ONLY COME AND TALK
ABOUT THE WHOLE THING WITH THE
PIER REVIEW CRITERIA BEING
PART OF IT. SO WE HAVE A
NUMBER OF OTHER INITIATIVES TO
PROMOTE FAIRNESS AND REVIEW.
FIRST OF ALL, WE CONDUCT
ANNUAL SUMMER CHAIR
ORIENTATIONS FOR 90 INCOMING
CHAIRS AND NINE TO TEN SMALL
GROUPS.
THAT'S ABOUT HALF OF THE STUDY
SECTION CHAIRS AND SO NEW ONES
COME IN.
THERE IS A SAMPLE POSTED ON
OUR WEBSITE.
BUT IT TALKS ABOUT A
OVERVIEW.
BUT MOST OF IT IS A BASED
DISCUSSION AMONG THE CHAIRS.
WE MAKE SURE THAT WE EXPLAIN
TO CHAIRS AND TALK TO THEM
ABOUT THEIR INFLUENCE ON THE
ENTIRE STUDY SECTION AND THE
OUTCOMES.
HOW TO FOSTER A STRONG
POSITIVE STUDY SECTION
CULTURE.
IN ADDITION THE BIAS AWARENESS
TRAINING, WAS RELEASED IN
AUGUST TWO BUN.
>> THIS IS NOT IMPLICIT BIAS
TRAINING, WE ARE NOT INTENT ON
CHANGE HEARTS AND MINDS, FOUR
WEEKS BEFORE.
OUR GOAL IS TO PREVENT THE
BIASES THAT WE ALL KNOW EXIST
OUT IN THE COMMUNITY.
PEER REVIEW IS JUST A
MICROCOSM OF THE COMMUNITY.
19,000 OF OUR BESTFRIENDS.
BUT WE ALL HAVE THAT.
WE'RE TRYING TO PREVENT THE
BIASES THAT EXIST OR MITIGATE
THAT INFLUENCE.
SO THIS IS A VERY TARGETED
TRAINING RELATED TO PEER
REVIEW.
IT'S 30 MINUTES ALONG, SO FAR
MORE THAN 24,000 REVIEWERS
HAVE TAKEN THE TRAINING.
IT'S BEEN REALLY WELL RECEIVED
BY THE SCIENTIFIC COMMUNITY,
WE HAD POSITIVE RESPONSES FOR
REVIEWERS ABILITY TO IDENTIFY
BIAS.
AND WE ALSO HERE IT IN ACTUAL
STUDY SECTION MEETINGS WHERE
PEOPLE REFER TO TRAINING.
SO THAT IS GOOD.
SO, THE LEADERSHIP HAVE
REQUIRED THIS CSR TRAINING TO
BE MADE AVAILABLE TO ALL NIH,
WITH REGARD TOFFECT-MARCH
MEETINGS, SO WE'RE WORKING ON
MAKING THAT HAPPEN.
IN ADDITION REVIEW INTEGRITY
HAS A BIG EFFECT ON THE
OUTCOMES AND THE FAIRNESS OF
REVIEW.
YOU ONLY NEED SOMEONE TO
TAMPER WITH ONE APPLICATION
OUT OF 60 AND THAT AFEBRUARIS
EVERYTHING ELSE.
SO WE HAD A REVIEWER INTEGRITY
TRAINER MODULE, AND WE'RE
BETTER NOW.
SO WE PRODUCED A VERSION TWO.
WE DID THIS ALSO, BOTH WERE
DONE WITH THE EXTERNAL
COMMUNITY THROUGH OUR COUNCIL
WORKING GROUPS.
SO IN AN INTERACTIVE TRAINING
BASED ON THE REVIEWERS ROLE,
FOR CONFIDENTIALITY AT ALL
STAGES.
SO ONE OF THE THINGS WE HEARD,
IS THEY WANTED ACTUAL TOOLS ON
HOW TO DEAL WITH SITUATIONS
THAT ARISE.
WHEN YOU'RE OUT THERE AT AT
CONFERENCE EXSOMEONE SAYS, MY
APPLICATION IS UP.
I KNOW YOU'RE A REVIEWER, WHAT
DO YOU DO IN THE MOMENT?
IT'S IMPORTANT THAT WE NOT
JUST COOPERATE.
BECAUSE THAT AFFECTS THE
INTEGRITY OF THE ENTIRE
PROCESS.
SO THESE ARE BASED WITH INPUT
OF THE EXTERNAL COMMUNITY WITH
ACTUAL CASES.
MORE THAN 17,000 REVIEWERS
HAVE COMPLETED THIS TRAINING
SINCE ITS LAUNCH IN FALL OF
LAST YEAR.
THIS TOO IS GOING TO BE
REQUIRED OF ALL NIH REVIEWERS
STARTING WITH THE SAME CYCLE.
AND THEN WE KNOW THAT WITH 60,
000 APPLICATIONS AND 19,000
REVIEWERS IT'S NOT GOING TO BE
PERFECT.
1200 MEETINGS, IF WE DON'T
KNOW WHAT'S GOING ON, WE CAN'T
ADDRESS IT. SO WE ESTABLISHED
A DIRECT MECHANISM.
THIS IS OPEN TO ANYONE,
APPLICANTS, REVIEWERS AND, IF
YOU SEE SOMETHING HAPPENING,
REPORT IT.
BECAUSE WE INVESTIGATE
EVERYTHING.
THIS IS INCLUDED IN THE
SIGNATURE OF ALL 600 CSR
STAFF.
SO YOU CAN NEVER SAY I DON'T
KNOW HOW TO REPORT IT.
LOOK FOR AN EMAIL FROM
SOMEONE.
>> GABRIEL IS OUR ASSOCIATE
DIRECTOR AND HE, THE EMAIL
GOES TO HIM AND HE'S A DIRECT
REPORT TO ME.
HE AND THE SCIENTIFIC DIVISION
DIRECTOR INVOLVED INVESTIGATE
EVERY ALLEGATION.
ABOUT HALF OR LESS THAN HALF
OF THE REPORTS COME THROUGH
THIS MEANS, MORE THAN HALF
COME THROUGH THE SRO. HE IS
THEY ARE AWARE REQUEST THEY
SAY THIS DIDN'T GO WELL OR
SOMEONE HAS REPORTED TO THEM.
SO WE FOLLOW THE SAME PROCESS
WHICH IS WE INVESTIGATE IT
CAREFULLY.
IF WE AGREE THAT REVIEW WAS
FLAWED WE REVIEW THE
APPLICATION IN THE SAME
COUNCIL ROUND.
WE DON'T WANT TO DELAY THEIR
FUNDING.
IF WE DON'T AGREE WE GUIDE
THEM TO NIH PROGRAM OFFICER
AND THE PROCESS THAT YOU ARE
FAMILIAR WITH CONTINUES.
SO THIS LAST BIT WAS ADDED
JUST IN THE LAST YEAR.
IN AN ATTEMPT TO FOSTER
CULTURE CHANGE.
WHAT HAPPENS IS, IF WE FIND A
BIASED STATEMENT BY A REVIEWER
THAT LEADS TO A RE-REVIEW, WE
HAVE THE DIRECTOR CALL THE
REVIEW SCBER SAID YOU SAID
THIS, THIS LED TO A COMPLETE
REDO AND THEN WE LOOK AT THE
REACTION OF THE REVIEWER.
A VAST MAJORITY OF THE TIME
PEOPLE ARE CONTRITE.
I DIDN'T NOTICE.
I'LL DO BETTER NEXT TIME.
THAT'S FINE.
A SMALL MINORITY OF THE TIME
THEY SAY THAT'S NOT REALLY
BIASED.
WELL THAT'S INFORMATION FOR US
AND AS ALWAYS WE RETAIN THE
AUTHORITY AND THE DIS CRAIGS
WHO WE CLUES TO INVITE OR NOT
INVITATORY VIEW COMMITTEES.
AND THEN DIVERSIFYING OUR
REVIEW PANELS.
SO, THE BROADER GOAL IS TO
BROADEN THE POOL OF REVIEWERS
WHERE SR OATHS GO TO FIND
REVIEWERS.
THEY HAVE DATABASES BUT THEY
ONLY HAVE NIH INTERACTING
REVIEWERS.
THERE'S A LOT OUT THERE WITH
EXPERTISE.
SO THIS IS A REVIEWER FINDER
TOOL THAT CSR HAS CREATED
WHICH HAS MULTIPLE DATA
SOURCES.
EARLY CAREER AND, ANY
RECOMMENDATION AND WE HAVE
THIS CATEGORY CALLED FUNDED
AND UNDER UTILITZED AND IT'S
NOT THAT THEY'RE SAYING NO.
SOME HAVE NEVER BEEN ASKED.
WE WANT THE RADAR TO BE
BROADER.
AND OTHER AGENCY AND SOCIETIES
CAN RECOMMEND.
WE HAVE A SPECIAL PORTAL.
BUT A TOOL ISN'T GOING TO
SOLVE YOU KNOW, SORT OF THE
CULTURE ISSUE THAT WE ARE
LOOKING TO CHANGE INTERNALLY.
SO, THE FIRST PART THAT WE
HAVE DONE IS TO MAKE SURE THAT
WE EMPHASIZE HOW IMPORTANT IT
IS FOR THE AGENCY, NIH TO HEAR
DIVERSE PERSPECTIVES.
BECAUSE WE WANT PEER REVIEW TO
IDENTIFY THE MOST DISRUPTIVE
SCIENCE.
WE WANT A BROAD RANGE OF INPUT
COMING IN.
HOW WE DEFINE DIVERSITY IS
ALSO IMPORTANT.
GIO GRAPHIC IS PART OF OF IT
BUT IT'S ALSO SCIENTIFIC.
FOUR PEOPLE TRAINED THE SAME
LAB, YOU WILL GET DERIFT HAVE
ATISM WE WANT PEOPLE WITH A
LOT OF PEER REVIEW EXPERIENCE
AND PEOPLE WHO HAVE NEVER DONE
REVIEW BEFORE AND A LITTLE
BIT.
WE WANT A MIX.
LEARNING THAT BACK TO QUALITY
HAS BEEN EFFECTIVE FOR US.
WE'RE DOING OKAY.
WE HAVE ALWAYS DONE OKAY WITH
STANDING STUDY, MEMBERSHIP.
I SIGN OFF ON EVERY P 23407
MINI AND IT GOES TO NIH
DIRECTOR.
THAT'S ALWAYS HAD ENHANCED
DIVERSITY MUCH THAT WASN'T THE
CASE FOR THE SPECIAL PANELS.
THEY ARE QUICKLY ASSEMBLED AND
THEN, THERE'S A TIME
LIMITATION, PEOPLE TEND TO GO
TO THEIR FAVORITE NETWORKS AND
PEOPLE THEY KNOW, THE MENTAL
ROLE LOW DECKS.
AND WE ARE TRYING TO BREAK
AWAY FROM THAT.
SO WE RAISED COLLECTIVE
AWARENESS.
WE SHARE DATA A LOT ACROSS THE
CENTER.
THE TOOLS THAT I ALREADY
MENTIONED, ARE THE MOST
IMPORTANT HAVE BEEN SRO TO SRO
ENGAGEMENT AND STRATEGY
SHARING FOR BROADER RECRUIT
MENT PRACTICES.
SO, OKAY.
CSR CONTINUES TO INCREASE THE
DIVERSITY OFFICE REVIEWER
POOL.
LET'S START WITH WOMEN.
THE BLUE, THE DARK BLUE IS THE
NUMBER OF P.I.S THE PERCENTAGE
OF P.I. THAT ARE WOMEN.
YOU CAN SEE IT STARTS
OCTOBER 2019, AND GOES TO
2023.
SO THIS BLUE IS THE WOMEN
WHICH IS AROUND 35% AND IT'S
FAIRLY FLAT.
MEMBERS ARE UP TOP.
THEY'RE ALWAYS ENRICHED.
MORE WOMEN, IN MEMBERSHIP.
AND AROUND 45% INCREASE.
IF YOU LOOK AT THE SPECIAL
EMPHASIZE PANEL REVIEWERS,
WHEN WE STARTED MAKING OUR
INTERVENTIONS, IT CHANGED.
SROS CAME ONBOARD AND WERE
ABLE TO IDENTIFY MORE
QUALIFIED WOMEN.
UNDER-REPRESENTED MINORITY,
SO, THIS RED IS THE P.I.S WHO
ARE UNDER-REPRESENTED
MINORITIES.
IT IS REFLECTIVE OF NIH.
IT WENT FROM 8-9% OVER FOUR
YEARS.
ON TOP HERE IS MEMBERS, AGAIN,
MORE ENRICHED IN MEMBERS, MORE
UNDER-REPRESENTED MINORITIES
THAN WE SAW BEFORE.
WHEN YOU LOOK AT STEP
REVIEWERS, THAN THE BENCHMARK
UNTIL THE INFROM A VENTION, IT
TOOK LONGER.
BUT, AGAIN, THE NUMBER HAS
INCREASED ON STEPS.
AND THESE ARE LEARNED BECAUSE
AS PEOPLE TRY OUT AS A
REVIEWERS AND THEY'RE STRONG
THEY THEN GET NOMINATED FOR
MEMBERSHIP.
WE HAVE A LOT MORE.
YOU'RE WELCOME TO EXPLORE OUR
WEBSITE, AND A LOT MORE
DETAIL.
I INVITE YOU TO TAKE A LOOK.
I'M HAPPY TO DISCUSS AND
ANSWER QUESTIONS.
QUESTIONS FROM THE GROUP.
>> FIRST OF ALL, THANK YOU.
IT'S ALMOST AN IMPOSSIBLE TASK
I THINK THAT YOU HAVE.
IT IS GETTING MORE AND MORE
DIFFICULT I AGREE THAT WE ALL
SEE INTERNATIONALLY THE NIH
SYSTEM AS IMPERFECT AS IT
MIGHT BE STILL AS THE GOLD
STANDARD.
SO TO SEE THAT YOU'RE TRYING
TO IMPROVE IT IS VERY
REASSURING.
A COUPLE OF CONCERNS.
I THINK THAT IN OUR
MUTUATTEMPTS TO OPTIMIZE THIS,
BY NOT ONLY ASSURING FAIRNESS
AND PROCESS AND CONTENT AND
EQUITY AND DIVERSITY AND WE
KEEP PILING IT ON, WE MAY BE
UNABLE TO CONTROL SOME OF THE
MORE, AT THE IN CRITICAL
FACTORS WHICH, IN MY OPINION,
AS A LONGSTANDING
INVESTIGATOR, HAVE TO DO WITH
FAIRNESS PROCESS AND THE
CONTENT OF THE REVIEW.
WHICH GOES BACK TO DIAGRAM.
THE STUDY SECTION, THE
OPPOSITION OF THE STUDY
SECTION, THE EXPERTISE THAT
THEY TAKE, SIGNIFICANT OVERLAP
THERE AS WELL AS WITH PROCESS.
SO, IT TAKES ME TO MY COMMENT
WHICH I THINK REFLECTS A
CONCERN THAT I KNOW A LOT OF
MY COLLEAGUES SHARE.
AGAIN I HAVE LIVED THROUGH
THIS, OF THESE STUDY SECTIONS
TO DEAL WITH VISION SCIENCE IS
A LOT OF THE R.O.1S GO TO
THESE TWO STUDY SECTIONS ONE
AND TWO.
WHICH ARE DESIGNED TO BE, TO
COVER THE SAME.
SO WHEN YOU'RE DEALING WITH
25, 30 INDIVIDUALS IN A STUDY
SECTION, BOTH OF WHICH ARE
DESIGNED THE SAME WAY, THE
FOCUS GOES ON BREATH AS
OPPOSED TO DEPTH.
ON THE ONE HAND OUR SCIENCE IS
BECOMING MORE AND MORE
SPECIALIZED AND DEPTH IS VERY
ARE THE CLUE.
SO HAVING SERVED ON A VARIETY
OF THESE STUDY SECTIONS, I
HAVE, AS A REVIEWER, I HAVE
RECEIVED CONCERNS, BECAUSE I'M
AN IMMONOLOGUIST, I GAVE
GRANTS THAT ARE NOT
IMMUNOLOGY.
SIMILARLY PEOPLE WHO DABBLE IN
INFLAMMATION AND IT GETS
ASSIGNED VERY COMPLICATED
GRANTS.
THAT IS SOMETHING THAT I THINK
WE'RE DEALING WITH NOW MORE
THAN WE DID A COUPLE OF YEARS
AGO WHERE WE WENT THROUGH THIS
TRANSITION PHASE WHERE WE HAD
A STUDY SECTION THAT DEALT
WITH CORNEA AND GLAUCOMA, SO
THERE WAS A FAIR AMOUNT OF
DEPTH AND ANOTHER ONE, EARLY
BACK OF THE EYE.
THE RETINA, AND WHICH HAS THE
DEPTH IN IT.
BUT NOW, AGAIN, IT'S THINNER,
AND IT'S MORE SPREAD WIDE.
WHAT ABOUT THAT?
YOU SAY THAT YOU LOOK AT THE
COMPETITION.
IT'S NOT AS MUCH ABOUT
INDIVIDUALS INVOLVED.
THEY'RE ALL GOOD SCIENTISTS.
BUT WE ARE CONCERNED THEY MAY
NOT HAVE THE DEPTH THAT THEY
NEED.
>> THANKS FOR THAT QUESTION.
SO YES, START WITH THE LAST
POINT.
WE'RE NOT JUST LOOKING AT THE
INDIVIDUALS.
THE ENTIRE SLATE OF NOMINEES
IN CONJUNCTION WITH WHO IS
SERVING AND THE BALANCE OF
EXPERTISE AND HOW THAT ALIGNS
WITH THE SCIENCE AND THE
APPLICATIONS THAT ARE DONE.
VERY MUCH SOMETHING WE LOOK AT
FOR MEMBERSHIP.
SO, UNADEPT OF EXPERTISE IS IN
SOME WAYS SUBJECTIVE.
PART OF THIS IS, ONE OF THE
THINGS WE STRUGGLE WITH IS TOO
MUCH NARROW SPOT ON
EXPERTISE.
WE'RE NOT CHARGED WITH
REVIEWING JOURNAL ARTICLES.
THESE ARE FIVE YEAR BROAD PROG
JECTS. WE WANT THERE TO BE
SOME EXPERTISE.
WE WANT THE DEEPER EXPERTISE.
THEY DO A GOOD JOB OF
BALANCING THAT OUT.
IN TERMS OF WHAT ANALYSIS WE
HAVE DONE, WE HAVE AT ONE, AND
SEE WHAT THE OUTCOMES LOOK
LIKE.
WE CAN SHARE THAT AT A
DIFFERENT TIME.
AND I'LL SHARE THAT WITH MIKE
AND HIS STAFF SO THEY CAN LOOK
AT THE OUTCOMES AND SEE THAT
WE DON'T HAVE AS MANY
EXPERIENCE AS YOU MIGHT SEE,
GLOBALLY AS YOU LOOK AT IT, WE
HAVE LOOKED AT NOT JUST OF THE
NUMBER OF APPRAISALS KAS AND
NUMBER OF EXPERTS THE OUTCOMES
OF THE DIFFERENT SEGMENT
APPLICATIONS, THE SCORING BY
POSTERIOER ON ANTERI OR
SEGMENT, WHETHER THEY KILL
THEM.
THEY DON'T.
SOME OF THEM THAT ARE RATED
POORLY ARE RATED POORLY BY
EVERYONE.
SO I THINK IT'S HEALTHY TO
HAVE A PERSPECTIVE, ON EVERY
APPLICATION.
WHAT THAT LOOKS LIKE VARIES BY
FIELD AND BY STUDY SECTION AND
THAT'S WHERE THE SROS COME IN
TO TRY TO RECRUIT PEOPLE WHO
HAVE THE BREATH AND THE DEPTH
BUT WE CAN'T GET THE LEVEL OF
DEPTH THAT YOU'RE REFERRING TO
THAT YOU NEED FOR INTERNAL
ARTICLES.
>> MAYBE NOT SATISFACTORY BUT
THAT'S OUR BROADER GOAL.
>> WELL -- I GO MORE TO SORT
OF LIKE THE DETAILS OF THIS
STUDY SESSION AND MAKE
APPLICANTS VERY FRUSTRATED.
THEY HAVE A LOT TO DO WITH
THAT.
IT'S VERY FRUSTRATING, WHEN
THEY GET A SCORE GRANT THEY --
THE COMMENTS OF THE REVIEWERS
ARE TOTALLY DESPAIR AND THIS
WAS THE BEST POINT OF THE
GRANT.
THIS KILLED THE GRANT.
ONE OF THE THINGS THAT IS NOT
DONE REALISTICALLY IS THAT
WHEN THERE'S A UNDER SCORE IS
THE REVIEWERS ARE SUPPOSED TO
TALK TO EACH OTHER ABOUT, TO
DISCUSS IF AND REAL
DISCREPANCIES, THAT DOESN'T
HAPPEN.
SO THAT'S ONE OF THE
FRUSTRATION THAT'S HAPPEN.
ANOTHER ONE IS LIKE AGAIN, THE
UNDERSCORE ONE, THEY DON'T
KNOW WHERE YOU ARE.
YOU DON'T KNOW IF YOU JUST
MISS IT BY ONE OR IF YOU ARE
AT THE BOTTOM OF THE LIST.
BECAUSE NEED SOME KIND OF
NUMBER OR SOMETHING, SOME KIND
EVER RANK FOR THE UNDERSCORE.
YOU DON'T KNOW IF YOU WERE AT
THE BOTTOM OR JUST BARELY MADE
IT.
BECAUSE WHEN YOU LOOK AT THE
INDIVIDUAL SCORES, SIGNIFICANT
AND ALL OF THAT, SOMETIMES
THERE IS NOT MUCH DIFFERENCE.
THAT'S ANOTHER THING.
ANOTHER SET OF PRACTICAL THING
IS THAT, YOU KNOW, AM STUDY
SECTIONS THEY DON'T HAVE
REALLY ENOUGH BODY OF STANDING
MEMBERS.
WHEN YOU SUBMIT YOUR GRANT IS
ANOTHER ONE AND, THINGS THAT,
BRINGING UP NEW THINGS.
SO YOU ADDRESS ALL THE THINGS,
THAT THE REVIEWERS FROM THE
FIRST ONE DID AND THEN YOU
FIND NEW THINGS THAT YOU
CANNOT ADDRESS.
SO, THOSE ARE THE KIND THE OF
DETAILS THAT MADE PEOPLE VERY
FRUSTRATED WITH THE RESULTS.
I REALLY LIKE ON THE REVIEWER
SIDE, THAT YOU INSERTED THE
EXPERTISE.
BECAUSE IN MY EXPERIENCE YOU
KNOW, YOU GET A NUMBER OF
GRANTS, THEY ARE BEAUTIFULLY
WRITTEN, LIKE THEY WERE
COPYING, FOR A PAPER AND THEN
YOU LOOK AT THE P.I., THEY
NEVER HAVE DONE IN THEIR
LIVES.
SO, THAT'S A GOOD POINT ON THE
CHANGES THAT THEY ARE COMING
BACK.
BUT THE OTHER ONES I WISH YOU
COULD ADDRESS.
>> SO THERE'S A NUMBER OF
POINTS I WANT TO MAKE SURE I
CAPTURED ALL OF THEM.
SO EXPERTISE I THINK WE AGREE
WITH ON THAT.
THAT'S IMPORTANT.
>> YOU TALKED ABOUT A. 1'S,
AND AMENDED APPLICATIONS,
COMING BACK.
>> THE FIRST ONES THAT THEY
ARE AN UNDER SCORE.
>> SO, LET'S TALK ABOUT
UNSCORED APPLICATION.
THE MORE WE SPEND TIME ON
THE -- IT'S NOT AN EXACT
SCIENCE.
SCORING WITH HUMAN BEINGS,
EVEN NINE BEENS IS HARD TO
DO.
WE SHOULD ACKNOWLEDGE THAT.
IT USED TO BE 1-5.
NOW IT'S 1-9 BEEN.
WHERE IT GETS RANKED.
BUT THAT DOESN'T MEAN THAT
THERE'S HUGE MEANING BETWEEN
YOU KNOW, A 16% AND A 17%.
THERE ISN'T.
THAT'S WHY THE CONTENT OF
SUMMARY STATEMENT IS SUPPOSED
TO BE THE THING THAT GUIDES
FUNDING DECISIONS IN THAT
CASE.
SO I THINK, IF YOU ARE VERY
CLOSE TO THE EDGE, THAT
CONTENT OF THE SUMMARY
STATEMENT SHOULD BE LOOKING
PRETTY GOOD.
AND WITH YOUR PROGRAM STAFF
THEY SHOULD BE HASN'T TO REACH
FOR THAT.
THERE'S A LOT OF DISCRETION
AVAILABLE AT THE I.C. LEVEL TO
BALANCE THEIR PRIORITIES TO
REACH AND MANY DO THAT.
SO IN THIS CASE I WOULD SAY
INSTEAD OF ADDING YET ANOTHER
SCORE, TO HAVE REVIEWERS RANK
IT, THE SUMMARY STATEMENT
CONTEND IS MOST VALUABLE.
>> BUT IF YOU ARE ON THE
RECEIVING PART, YOU RECEIVE IT
AND YOU DON'T HAVE ANY OTHER
IDEA WHAT HAPPENED.
>> THAT'S WHEN YOU HAVE A
DISCUSSION WITH YOUR PROGRAM
OFFICER TO SAY IS THIS CLOSE?
SHOULD I DO AN A ONE?
CAN YOU FUND THIS?
THERE'S AM WAYS TO GO ABOUT IT
THAT MIKE AND HIS STAFF CAN
TALK TO YOU.
>> I DIDN'T KNOW THAT.
HE CAN TELL YOU MORE OR LESS
WHAT YOU.
>> I DON'T KNOW IF THEY CAN
TELL YOU WHERE THEY RANK BUT
THEY CAN READ THE SUMMARY
STATEMENT AS YOU CAN AND SAY
THIS IS A VERY GOOD GRANT AND
IT'S PRETTY GOOD.
IF YOU FIX THIS, AND THIS
HOPEFULLY THAT'S HAPPENING
ALREADY.
SO THAT'S THE UNSCORED POINT.
I DON'T THINK ADDING MORE
SCORES, IS GOING TO LOOK LIKE
WE'RE ADDING VALUE BUT I DON'T
THINK WE ARE.
>> LOOK AT THE SUMMARY
STATEMENT.
>> AND THEN THE OTHER THING
YOU MENTIONED WAS THE
AMENDED.
>> THE REVIEWERS WHEN YOU
DON'T GET A STANDING MEMBER
AND YOU DO AN A ONE AND YOU
ADDRESSED EVERYTHING AND DID
IT AND HERE THEY COME.
>> SO THAT I COMPLETELY
UNDERSTAND HOW FRUSTRATING IT
IS.
IF IT WERE UP TO ME, THERE
WOULD BE NO A.1.
BECAUSE I THINK IT SETS UP AN
EXPECTATION, THE INTEREST OF
NIH IS TO IDENTIFY WHAT THE
IMPACT OF THAT PROPOSAL IS.
YOU GET THREE PEOPLE NOW AND
LATER, GOLD STANDARD OR NOT.
IT'S A PERSON BASED REVIEW.
THAT'S DIFFERENT FROM OTHER
PLACE THAT'S DO
COMPUTATIONAL.
IT'S NOT MACHINE BASED.
SO YOU ARE GOING TO HAVE
PEOPLE COMING IN WITH THEIR
OPINION. BUT THAT'S WHAT YOU
WANT, TOO.
YOU DO WANT PEER REVIEWERS
GIVING THEIR HONEST OPINION.
THE GOAL IS NOT TO MAKE THINGS
BETTER, I UNDERSTAND FROM THE
P.I. PERSPECTIVE THAT'S WHAT
THEY WANT.
>> BECAUSE YOU'RE GOING TO
MEET AGAIN.
>> MAYBE WE SHOULDN'T HAVE
A.1S.
>> MAYBE NOT.
I HAVE ONE MORE THINK THAT I,
YOU KNOW, THERE IS THIS
SCIENCE HAS CHANGED A LOT.
I MEAN FROM -- AND, BEFORE YOU
COULDN'T HAVE A GRANT THAT IT
GOES -- IF IT WAS NOT A HIGH
POT THOUGH SIS DRIVEN GRANT.
SO, YOU, SCIENCE IS NOT
HYPOTHTHOUGH SIS DRIVEN.
IT'S DATA AND UNDERSTANDING
DATA AND THEN YOU STILL GET
THOSE COMMENTS FROM THE
SUMMARY STATEMENTS AND THE
PROGRAM THAT THESE GRANTS ARE
NOT HIGH POT THOUGH SIS.
>> YOU SHOULDN'T GET THAT
COMMENT.
THAT'S FLAWED.
THAT SHOULD BE BROUGHT TO
SOMEONE'S ATTENTION
SOMEWHERE.
>> OKAY.
WELL.
>> BECAUSE WE HAVE -- 40 STUDY
SECTIONS THAT REVIEW JUST
TECHNOLOGY AND DATA SCIENCE
AND WE HAVE COME A LONG WAY
SINCE 1990.
NO, THAT THERE IN SRO
TRAINING, IT'S SOMETHING THAT
SLIPPED THROUGH THE CRACKS.
>> AND ANOTHER COMMENT, THAT
YOU GET A PERSON LIKE OH, THE
THREE SPECIFIC AMES, THEY ARE
TOTALLY INDEPENDENT.
AND THEN YOU GET THE OPPOSITE
COMING.
SO THOSE THINGS THEY NEED TO
BE UPDATED IN TERMS OF
COMMENTS.
>> RIGHT.
I AGREE WITH YOU.
>> THANKS VERY MUCH FOR MAKING
THOSE COMMENTS.
I SEE, SO, LET ME SEE IF
THERE'S OTHER QUESTIONS.
THANK YOU FOR COMING.
I HAVE TWO QUESTIONS, IF YOU
CAN, GIVE US A LITTLE BIT MORE
OF AN IDEA, THE DIVERSITY,
WITH NO EXPERIENCE, WHAT
PERCENT, AND SECOND?
BECAUSE YOU HAVE THE BREATH OF
ANOTHER CSR, WHAT ARE WE DOING
GOOD AT N.I.
>> I'M NOT GROWING TO TOUCH
THAT LAST ONE.
YOU'RE DOING GREAT.
>> HOW DO WE SORT OF
DETERMINE?
SO WE DON'T HAVE QUOTE IF AS
OR BENCHMARKS.
BEFORE THERE WAS FIVE YEARS
AGO THERE WAS THIS
REQUIREMENT, SO-CALLED THAT
70% OF MEMBERS SHOULD BE FULL
PROFESSORS AND THEN OF COURSE,
PEOPLE EXINTERPRET THAT MEANS
75% IS GOOD.
80% IS EXCELLENT AND 100%,
MEANS I'M THE BEST SRO.
AND WE STOPPED THAT AND WE
SAID RECRUIT MORE.
WE'RE ABOUT 45-45-10.
>> THAT'S A GOOD MIX.
BUT WE HAVEN'T PUT THAT OUT AS
BENCHMARKS.
>> I WAS GOING TO MENTION
THAT, WHAT CSR INSPIRED US TO
DO.
THEY HAVE A EARLY CAREER
REVIEWER PROGRAM WHICH IT
INSPIRED NEI TO DEVELOP ITS
OWN AND IT'S A WAY TO BRING IN
PEOPLE WHO ARE NOT, DON'T HAVE
A LOT OF EXPERIENCE GIVING
GRANTS, BUT IT CAN DIP THEIR
TOE INTO THE REVIEW PANELS AND
GET EXPERIENCE ON HOW REVIEW
WORKS.
THEY ACTUALLY WILL SERVE AS A
SECOND DAIRY VIEWER ON A PANEL
AND IT HELPS THEM DEVELOP
THEIR OWN GRANT WRITING
SKILLS.
WE COPIED THAT FROM YOU.
THANK YOU FOR THAT.
>> NEI I THINK THAT'S WHAT'S
GOING WELL.
IS THE LEADERSHIP AND OPENNESS
AND INNOVATION.
>> I JUST WANTED TO REALLY SAY
THAT IT'S REALLY GOOD THAT YOU
HAVE CHANGES, FOR RESEARCH
RATHER THAN INNOVATION.
THERE'S AM TIMES WITH GRANTS
WITH TECHNOLOGY, AND, BUT
THEY'RE VERY IMPORTANT.
I REALLY APPRECIATE YOU
FOCUSING ON THAT RATHER THAN
JUST INNOVATION.
SO THESE NEW CHANGES ARE
REALLY GOOD.
>> OTHER COMMANDS OR
QUESTIONS?
IF I CAN JUST MAKE ONE QUICK
FINAL QUESTION.
I HAVE GOTTEN A PIECE OF
FEEDBACK, LITERALLY THREE
TIMES, BY DIFFERENT PEOPLE,
JUST A MEETINGS.
THE RATIONALE GOES LIKE, THEY
WERE ALL COMMISSIONS.
THEY SAID WELL, THE NUMBER OF
CLINICIANS ON STUDY SECTIONS
HAS BEEN DECREASING OVER THE
YEARS, IN THEIR OBSERVATION.
WHAT THEY FELT WAS THEY HAD A
UNIQUE ROLE TO PLAY IN WHAT'S
NOW CATEGORY NUMBER ONE,
SHOULD THE STUDY BE DONE?
WHAT THEY TOLD ME, ALL THREE
OF THEM, WAS THAT THEY FELT
THAT THEIR EXPERTISE COULD BE
BETTER SERVED IN ADDRESSING
THAT FIRST ISSUE SHOULD THE
STUDY BE DONE?
IS IT IMPORTANT, RATHER THAN
THE DETAILS ABOUT CURRENTLY
USED TO CALL APPROACH.
SO WHAT THEY WONDERED COULD
THE CLINICIANS PLAY A ROLE IN
LOOKING AT THE SIGNIFICANCE OF
A BROADER NUMBER OF STUDIES
RATHER THAN A SMALLER NUMBER
OF STUDIES WHERE THEY READ
THROUGH EVERYTHING.
HAVE YOU HEARD THAT?
WHAT'S YOUR REACTION?
>>> SO I THINK JUST SORT OF
WHAT I WAS SAYING IS THAT
HAVING THAT, IF SOMEBODY IS
DEEP IN THE FIELD THEY EITHER
HATE HOR LOVE THE GRANT.
THAT'S WHAT WE SEE.
SO HAVING THE BROADER
PERSPECTIVE.
DO WE CARE IS REALLY
IMPORTANT.
THAT'S A INTERESTING IDEA AS
WE GET TO NEW FACTOR BASED
REVIEWS.
WE DO MONITOR THE
PARTICIPATION OF CLINICIANS ON
OUR COMMITTEES.
I HAVEN'T LOOKED AT THE I.
PANELS.
BUT WE DO HAVE SOCIETY
DATABASES.
SO, I WOULD ENCOURAGE YOU TO
LET SOCIETIES AND THOSE NASA
SPORT CLINICIANS SUBMIT
NAMES.
TARGETED TO DIFFERENT PANELS.
ANY FINAL COMMENTS.
>> INTERESTING THOUGHTS BUT I
THINK THAT WOULD WORK ONLY IF
YOU HAD A MINIMUM OF
CLINICIANS SCIENTISTS IN THE
ROOM.
SO IF YOU HAVE TWO, WHICH
OFTEN IS THE CASE, SOMETIMES
ONE, THEN YOU KNOW DEPENDING
ON THE EXPERIENCE, AND BIASES,
YOU CAN UNDERSTAND THE IMPACTS
OF THE PROPOSAL.
>> THERE'S HAT ON REASON TO
HAVE MORE THAN ONE OR TWO, IS
THAT YOU DON'T WANT THEM TO BE
OVERWHELMED OR DISMISSED BY
THE REST OF THE COMMITTEE.
BUT HERE'S THE PROBLEM WITH
AIM 3C.
IT'S IMPORTANT TO HAVE A
CRITICAL MASS.
I AGREE.
>> THANK YOU VERY MUCH FOR
COMING.
>> IT'S BEEN GREAT
>> THANK YOU
>> SO, MIKE CAMP CHANG
SPEAKING.
CAN I, RIGHT NOW, IN AGENDA
TEMPT IS OPEN DISCUSSION.
WE'VE TALKED ABOUT A LOT OF
THINGS HERE TODAY.
STARTING WITH DIRECTOR'S
REPORT, AND THEN ALL OF US
DATA SCIENCE, DATA STANDARDS
AND THEN PEER REVIEW AND OF
THOSE CONCEPT CLEARANCES.
IF ANY OF YOU HAVE COMMENTS OR
THINGS THAT YOU FELT YOU
DIDN'T HAVE TIME TO SAY
EARLIER, PLEASE SPEAK UP.
>> I WAS WONDERING IF IT
THERE'S AN OPPORTUNITY AT ANY
POINT TO SORT OF CENTRALIZE
I.R. B. SUBMISSIONS.
IT APPLIES TO WHAT WE
DISCUSSED.
BUT IF MY EXPERIENCE WE SPEND
A TREMENDOUS AMOUNT OF TIME TO
GET SIMPLE PROTOCOLS APPROVED
IF WE HAVE ONE -- THE MAIN
INSTITUTION IS, LET'S SAY --
IT DOESN'T MATTER THE MAIN
INSTITUTION APPROVES IT AND
THEN THE OTHER SUPPLEMENTAL
INSTITUTIONS, THERE'S SO MUCH
BACK AND FORTH, AND NO ONE
KNOWS WHAT THEY ARE DOING.
BECAUSE THEY CAN'T UNDERSTAND
THE DIRECTIVES FROM ABOVE.
SO I JUST THINK, SOMETIMES
WE'RE INUNDATED WITH A LOT OF
STUFF THAT ISN'T IMPORTANT
GETTING THE SCIENCE DONE.
IT WAITS A LOT OF ENERGY.
I FEEL LIKE WE SHOULD TRY TO
MAKE IT BETTER SO WE HAVE MORE
CLINICAL RESEARCH INTO STUDIES
OR JUST NOT CLINICAL TRIALS,
BUT JUST -- IT JUST SEEMS LIKE
WE SHOULD, THE COMMUNITY TRY
TO MAKE THAT BETTER FOR
EVERYONE.
>> LET ME, I'M GOING TO PUNT
THIS QUESTION NO SOME PEOPLE
BEHIND ME.
LET ME SUGGEST THAT PERHAPS
DON ORR SOMEONE LIKE JIMMY
MIGHT -- WHAT I'M WONDERING,
SINGLE IRB, WAS.
[LAUGHTER]
>> SINGLE IRB SUBMISSION WAS
SOMETHING THAT WAS MEANT TO
ADDRESS.
>> IS THAT WORKING?
MAYBE YOU HAVE IT?
[INAUDIBLE]
HI, I THINK NIH IN CONCEPT
FEELS THAT SINGLE IRB
FRAMEWORK ISMENT FACILITATE
APPROVAL AND MY OWN
EXPERIENCE, AND MY COLLEAGUES,
CAN ECHO THAT STILL EVEN
THOUGH THERE IS A SINGLE IRB
OF RECORDS, INDIVIDUAL
INSTITUTIONS REQUIRE THEIR OWN
REVIEW AND APPROVAL.
THAT IS PROBLEMATIC.
BUT I THINK THOSE
INSTITUTIONAL ISSUES THAT NEED
TO BE DEALT WITH.
I DON'T KNOW HOW.
DON.
>> MARIA REYES A GREAT POINT,
BECAUSE INSTITUTIONS HAVEN'T
CAUGHT UP WITH THE IDEA.
THERE ARE VERY FEW GROUPS THAT
CAN PERFORM THE IRB REVIEW.
IT'S EXPENSIVE.
THE GRANT RESOURCES ARE GOING
MORE TO IRB THAN TO SCIENCE.
THE TIME OF THE INVESTIGATOR
IS GOING MORE TO RECEIVE
APPROVAL THAN TO SCIENCE
ITSELF.
IT CAN TURN INTO QUITE THE
BURDEN.
THANK YOU FOR RAISING A REALLY
IMPORTANT ISSUE.
>> THIS IS DON, I WANT TO ECHO
WHAT DON SAID.
THE COST HAS BECOME A HUGE
PROBLEM.
IT'S A DIRECT RATE AND EVERY
TIME, A LOT OF INSTITUTIONS
ARE GOING TO THESE SINGLE IRBS
AND EVERY TIME YOU HAVE A
LITTLE MODIFICATION THEY
CHARGE NOR IT.
YOU HAD SOMETHING, IT WENT
FROM $2,000 TO $6,000 OVER
$15,000.
THIS IS NOT A LARGE GRANT.
THEY ARE GOING TO GET IT
APPROVED RATHER THAN DOING THE
WORK.
>> I'M MAUREEN MCGWIRE, IT HAS
AN IMPACT ON THE STUDIES AND
THE STUDY DESIGN.
ONCE WE GET A CLINICAL TRIAL
THROUGH 45 IRBS THERE IS GREAT
RESISTANCE TO MAKE ANY CHANGE
WHATSOEVER, EASTERN IF IT IS
BETTER FOR THE PATIENTS AND
BETTER FOR THE TRIAL.
IT'S JUST WE CANNOT GO ON WITH
MORE DELAYS AND YOU KNOW, THIS
WILL COST SO MANY HOURS OF
TIME.
LET'S JUST EITHER NOT DO IT OR
WAIT UNTIL WE GET IT, AND DO
IT TOGETHER.
BUT IT IS NOT HELPING OUR
STUDIES MUCH.
>> THANK YOU FOR RAISING THOSE
POINTS AND KICKING THAT OFF.
OTHER COMMENTS?
OKAY WELL WE DON'T HAVE
ANYTHING -- SORRY.
I JUST HAD A QUICK QUESTION.
JUST, WE HEARD A LITTLE BIT
ABOUT THE. INDEX CHALLENGE
THIS MORNING.
I THOUGHT THAT WAS
INTERESTING.
SO, I'M JUST CURIOUS IN THE
CONTEXT OF THE H.-INDEX FOR
PUBLICATION, HAS TO PASS SOME
BAR.
IS THERE SOMETHING LIKE THAT
FOR THE.-INDEX.
IF I SAY I'M PUTTING UP SOME
DATA, NO ONE HAS REVIEWED THAT
IT IS SENSE ABLE OR SOMETHING
LIKE THAT.
WHAT KIND OF IDEAS ARE THERE
TO ENSURE QUALITY OF DATA?
>>> YEA THAT'S A VERY GOOD
QUESTION.
THIS IS KERRY, SO WE ARE JUST
GETTING STARTED LEADING THIS
EFFORT AND WE HAVE HEARD
THAT.
AT THIS MOMENT WE ARE REACHING
OUT TO A VERY BROAD SWATH OF
INDIVIDUALS AND WE HAVE HEARD
FROM SOME INDIVIDUALS THAT
THEY HAVE CREATED METRICS THAT
PULL IN COMPONENTS OF QUALITY
OR OTHER FACTORS THAT AREN'T
JUST LEARNED TO PUBLICATIONS.
LIKE THERE ARE SO MANY
APPROACHES.
WE'RE ONLY STARTING TO SCRATCH
THE SURFACE WITH OUR
INTERVIEWS MUCH IT IS
FASCINATING.
WE JUST HAD OUR FIRST SET OF
MEETINGS YESTERDAY AND WE ARE
HEARING THE SAME THINGS.
THERE WILL BE MORE TO COME.
WE WILL, WE ARE PLANNING TO DO
A WORKSHOP SO I THINK YOU'LL
BE INTERESTED IN PARTICIPATING
IN THAT AND WE'LL CIRCULATE
THAT BROADLY.
WE'RE AIMING FOR PROBABLY LATE
SUMMER, EARLY FALL FOR THAT
WORKSHOP.
SO STAY TUNED.
>> THANKS.
AS MICHAEL BUT THE IT, IT'S
THE ONLY CAR OTT THAT PEOPLE
HAVE HEARD IN DATA SHARING.
I THINK IT'S IMPORTANT.
>> WE'RE ALSO VERY CAUTIOUS WE
DON'T WANT TO CREATE
UNINTENDEDDED CONSEQUENCES OR
TRASH THINGS THAT ARE GOOD.
I DO WANT TO THANK OUR CSR,
AND NIH, AND I URGE YOU THAT
YOU KNOW, HOW WE CAN HELP YOU,
CONTINUE TO MOVE FORWARD AND
ANY SUGGESTIONS REACH OUT TO
US SO WE CAN HELP.
>> VICTOR THANKS FOR ASKING
ABOUT THAT.
I THINK ONE OF THE THEMES THAT
CAME UP WHEN WE TALKED EARLIER
IS THAT WE DON'T WANT WHAT
HAPPENS IN BETH THESE TODAY TO
STAY HERE.
IT HAS TO GET OUT IN THE REAL
WORLD.
WE TRY TO USE SOCIAL MEDIA AND
PRESS TO GET OUT THERE.
WE HAVE TONS OF EMAIL BLAST
THAT'S WE TRY TO PUT OUT.
BUT I DON'T WANT THE SITUATION
TO BE THE PEOPLE WHO READ THEM
ARE THE PEOPLE WHO READ THEM.
I DON'T WANT THE SAME GROUP OF
PEOPLE.
WHERE I'M MADING WITH THAT WE
VIEW ALL OF YOU AS ONE OF OUR
PRIMARY GATEWAYS TO THE
SO-CALLED REAL WORLD.
SO, WHATEVER YOU CAN DO, WE
TALKED ABOUT A FEW OF THESE
THINGS TODAY OVER LUNCH.
THAT'S ONE OF THE BIGGEST ASKS
THAT I WOULD HAVE TO TRY TO
TAKE WHAT WE'RE TALKING ABOUT
HERE AND REPRESENT TO
COMMUNITY ABOUT WHAT IS
HAPPENING.
WHAT ELSE WOULD YOU ADD TO
THIS?
I APPRECIATE YOUR QUESTION.
>> I DON'T HAVE ANYTHING
SPECIFIC TO ADD.
BUT I CAN'T EMPHASIZE WHAT
MIKE SAID MORE STRONGLY.
IF YOU'RE A CONDUIT TO
COMMUNITY, AND SO YOU HELPING
US GET THE MESSAGE OUT ABOUT
WHAT WE'RE DOING.
WHAT WE'RE TRYING TO DO, THAT
IS, YOU HAVE A REMARKABLE
CACHE INTO YOUR GROUPS AND WE
ASK YOU TO HELP US DO THOSE
ACTIVITIES.
>> YEA I DON'T HAVE ANYTHING
TO ADD EITHER.
ONE OF THE PURPOSES OF
INVITING PEOPLE FROM OTHER
INSTITUTES, WITHIN NIH IS TO
LET YOU KNOW WHAT'S GOING ON
THERE.
SO NOT JUST WHAT'S GOING ON AT
NEI OR HEARING REALLY COOL
PRESENTATIONS BUT JUST SO
YOU'RE AWARE AND -- SO YOU CAN
BRING IT BACK TO YOUR
COMMUNITY.
SO, REALLY WANTED YOU TO HEAR
ABOUT THIS SIMPLIFYING REVIEW
FRAMEWORK.
BECAUSE THAT'S A BIT OF A
SHIFT.
SO THAT'S JUST AN EXAMPLE.
BUT IF THERE ARE, SO WHATEVER
WE DO HERE WE WANT,000 SHARE.
BUT IF THERE ARE OTHER TOPICS
THAT YOU WANT TO HEAR ABOUT
AND YOU FEEL WOULD BE HELPFUL
TO YOU AND YOUR COMMUNITIES,
PLEASE ALWAYS JUST LET ME KNOW
AND WE'LL GET THOSE DONE.
>> THANKS.
>> ANY OTHER COMMENTS?
CATHY WOULD YOU LIKE TO.
>> YEA, WHERE ARE WE.
>> OKAY SO, WE'RE GOING TO
TAKE A BREAK.
WE ARE FIVE MINUTES AHEAD AND
WE'LL COME BACK FIVE MINUTES
EARLIER AND TAKE A BREAK.
WELL OFFICIALLY ADJOURN THE
OPEN SESSION AND WE'LL TAKE A
BREAK AND PEOPLE WHO ARE --
WHO ARE GOING TO PARTICIPATE
IN THE CLOSED SESSION, IF YOU
ARE IN THE ROOM, PLEASE SIGN
IN AGAIN AND IF YOU ARE ON
ZOOM THERE'S A DIFFERENT ZOOM
LINK THAT YOU SHOULD HAVE
RECEIVED.
JUST THOSE TWO THINGS AND IF
ANYONE NEEDS A PARKING PASS,
LISA HAS PARKING PASSES.
THANK YOU ALL.
THAT WAS A WONDERFUL OPEN
SESSION.
I APPRECIATE ALL YOUR INPUT
AND WE'LL SEE YOU BACK HERE IN
15 MINUTES.
>> I REALLY APPRECIATE.
I JUST WANT TO SAY, I REALLY
APPRECIATE ALL OF YOUR
ENGAGEMENTS AND THE COMMENTS THAT YOU MADE.
SO I WILL BE HAPPY TO CLOSE THIS OPEN SESSION.