>>WELCOME TO TODAY'S
HEAL, MULTIDISCIPLINARY WORKING
GROUP MEETING.
NEXT SLIDE, PLEASE.
OKAY, SO, IN OUR LAST MEETING,
FEBRUARY 6th LAST WEEK, WE
TALKED A LITTLE BIT ABOUT SOME
OF THE RESEARCH THAT HEAL
LAUNCHED AT THE BEGINNING OF THE
INITIATIVE THAT IS NOW BEGINNING
TO MAKE PROGRESS, RETURN RESULTS
AND WE ASK FOR YOUR THOUGHTS AND
DISCUSSION AROUND THESE RESEARCH
PROJECTS.
NOW TODAY AND PART OF TOMORROW,
WE'RE GOING TO DISCUSS SOME OF
THE RESEARCH GOING FORWARD THAT
IS PROPOSED FOR THE NIH HEAL
INITIATIVE BY OUR SCIENTIFIC
TEAMS.
RESEARCH THAT IS DESIGNED TO
FILL GAPS IN OUR PORTFOLIO AND
STRENGTHEN OUR OVERALL RESEARCH
INITIATIVES, DEDICATION IS
COMMITMENT TO PROVIDING
SCIENTIFIC SOLUTIONS TO THE
NATIONAL CRISIS OF OPIOID
MISUSE, ADDICTION, OVERDOSE AND
PAIN WHILE ALSO MAKING SURE THAT
WE CONTINUE TO SERVE THE
POPULATIONS AND THE PEOPLE WITH
PAIN AND ADDICTION TO COME TO US
LOOKING FOR A SOLUTION.
SO THIS IS GOING TO END TOMORROW
AFTERNOON WITH A SYNTHESIS OF
THE RESEARCH WE HAVE LAUNCHED
AND WHAT WE'RE CONDUCTING
ALREADY AND WHAT WE HAVE UNDER
CONSIDERATION FOR THE FUTURE.
NEXT SLIDE, PLEASE.
STARTING WITH THE BROADEST
OVERVIEW, AND YOU KNOW THIS
WELL, BUT CONSIDERING HOW MUCH
WE WILL COVER AND HAVE ALREADY
COVERED STARTING WITH THE VERY
BIG PICTURE WHEN WE FIRST SET
OUT TO PROVIDE THESE SCIENTIFIC
SOLUTIONS AND WE LAUNCHED THE
HEAL INITIATIVE, WE SAT FORTH
WITH CERTAIN GOALS THAT YOU KNOW
WELL, SO THE FIRST BEING THE
NEED TO DISCOVER AND ACCELERATE
THE DEVELOPMENT OF SAFE AND
NONADDICTIVE TREATMENT OPTIONS
FOR A VARIETY OF PAIN
CONDITIONS.
TO UNDERSTAND, IDENTIFY AND
REDUCE THE RISK OF SUBSTANCE USE
DISORDER ADDICTION AS WELL AS
CHRONIC PAIN AND MINIMIZE THE
RISK OF SUICIDE.
TO INTEGRATE EFFECTIVE AND
SUSTAINABLE STRATEGIES FOR
PREVENTING OPIOID USE DISORDER
BEFORE IT BECOMES SEVERE,
IMPLEMENTING COMMUNITY FRIENDLY
AND EVIDENCE BASED INTERVENTIONS
THAT WE ALREADY HAD A LOT OF
DATA FOR, FOR REDUCING OVERDOSE,
AND PREVENTING OVERDOSE DEATH.
SUPPORTING PATHS FOR HEALTHY
DEVELOPMENT OF CHILDREN BORN
EXPOSED TO OPIOIDS DURING A
MOTHER'S PREGNANCY,
UNDERSTANDING THE CONS CONVINCES
OF THOSE EXPOSURES AND PROVIDING
EVIDENCE-BASED CARE IN THE
HOSPITAL, IMMEDIATELY FOLLOWING
BIRTH AND LASTLY, DEVELOPING AND
PROVIDING TO PATIENTS, A SUITE
OF USER FRIENDLY OPTIONS FOR
TREATING THEIR SUBSTANCE USE
DISORDER, OPIOID USE DISORDER
THAT REFLECTS THE WHOLE CYCLE OF
ADDICTION, CRAVING, WITHDRAWAL,
ALL THE ASSPECS THAT A PERSON
EXPERIENCES IN ADDITION TO THEIR
OPIOID USE DISORDER OR AS PART
OF THEIR OPIOID USE DISORDER SO
WE STARTED HERE WITH A REALLY
BIG PICTURE AND HERE ON THE
RIGHT SHOWS THE DIFFERENT
SCIENTIFIC TEAMS WHO COME TO YOU
BASED ON AREAS OF RESEARCH FOCUS
TO TALK ABOUT THE PROGRESS
THEY'VE MADE AND WHAT THEY
PROPOSE GOING FORWARD AND YOU
WILL SEE THIS IMAGE AND HEAR
FROM THESE TEAMS LATER OVER THE
NEXT 2 DAYS, NEXT SLIDE, PLEASE.
WHERE ARE WE NOW AND WHAT HAVE
WE ACCOMPLISHED TOWARDS THESE
GOALS.
AT THIS POINT, WE'VE SUPPORTED
OVER 2 AND HALF MILLION DOLLARS
OF RESEARCH, CONTRACTS
COOPERATIVE AGREEMENTS AND
GRANTS, OVER A THOUSAND
DIFFERENT RESEARCH PROJECTS,
ACROSS THE SPECTRUM, THESE ARE
ORGANIZE EDUCATIONAL INTO OVER
40 DIFFERENT PROGRAMS AND
SOMETIMES WE CALL THESE BY NAME
AND YOU'RE FAMILIAR WITH THE
COOPERATIVES AND COLLABORATIVES
THAT ARE PULLING TOGETHER THESE
MULTIPLE PIECES INTO COORDINATED
EFFORTS AND THESE PROJECTS ARE
UNDERWAY ACROSS ALL FIRST STATES
AND IN PUERTO RICO AND IN
INTERNATIONAL LOCATIONS, REALLY
SEEKING TO BUILD UPON ALL THE
EXPERTISE WE HAVE.
THIS IS THE BIOMEDICAL RESEARCH
COMMUNITY TO ROUGH ATOM VIED
THESE SCIENTIFIC SOLUTIONS.
WE HAVE A LARGE NUMBER OF
CLINICAL TRIALS, 314, ACTUALLY
WHICH IS REALLY IMPRESSIVE IN MY
OPINION, A LOT OF CLINICAL
TRIALS TESTING FOR OPIOID USE
DISORDER AS WELL AS PAIN.
OVER A HUNDRED DIFFERENT PRONL
ECTOMYOSINS FOCUSING ON BACK
PAIN SPECIFICALLY, LEADING CAUSE
OF DISABILITY IN THE UNITED
STATES, OVER WOHUNDRED PROJECTS
THAT ARE LOOKING SPECIFICALLY AT
DIFFERENT THERAPEUTIC STRATEGIES
FOR TREATING OPIOID USE DISORDER
WITH THE GOAL OF MORE USER
FRIENDLY OPTIONS FOR PATIENTS.
THIS HAS LED TO OVER 40 FDA, IND
APPLICATIONS, AND QUITE A FEW
ONGOING ACTIVE AND REALLY
INTERDISCIPLINARY PARTNERSHIPS
WITH OUR SISTER AGENCIES ACROSS
THE GOVERNMENT WITH OUR
COLLEAGUES IN THE PRIVATE SECTOR
ADVANCING THESE THERAPEUTIC
CANDIDATES TOWARDS
COMMERCIALIZATION, ACADEMICS AND
INSTITUTIONS WHERE WE'RE WORKING
TO BUILD IN THE NEXT GENERATION
OF RESEARCHERS AND COMMUNITIES
ACROSS THE COUNTRY.
SO NEXT SLIDE WILL SHOW A LITTLE
BIT MORE ABOUT THE BUDGET, SO
WHEN WE MET LAST WEEK, I THINK
THAT THERE WERE SOME FORMATTING
ISSUES IN THE WAY THIS WAS
DISPLAYED SO WE BROKE IN DOWN IN
A LITTLE BIT MORE SPECIFICS FOR
YOU ALL, 1 PIECE OF KIND OF
TRIVIA IS THAT IN 2019 BECAUSE
WE WERE GIVEN SO LITTLE TIME IN
2018 TO LAUNCH OUR FIRST SET OF
RESEARCH PROJECTS THROUGH THE
INITIATIVE, WE HAD KIND OF AN
EXTRA HALF YEAR AND SO IN FISCAL
YEAR 2019 WE SPENT 2 YEARS WORTH
OF MONEY IN 1 YEAR, THAT'S WHY
THIS BUDGET LINE GOES SO FAR
INTO FOR ME THE RIGHT SIDE OF
THE PAGE.
BROKEN DOWN INTO THE 6 DEFINITE
AREAS OF RESEARCH FOCUS THAT I
SHOWED YOU EARLIER, PRECLINICAL
AND THEN CLINICAL RESEARCH IN
PAIN MANAGEMENT ENHANCE OUTCOMES
FOR CHILDREN AND INFANTS AS
SHOWN IN YELLOW, NEW STRATEGIES
FOR PREVENTING AND TREATING
ADDICTION IN GROWN, TRANSLATING
RESEARCH TO PRACTICE IS IN THIS
SURELIAN BLUE, AND THE DARK BLUE
FOR OPIOID USE DISORDER AND
PREVENTING OVERDOSE AND OVER THE
TIME YOU SEE THE EMERGENCE OF A
CROSS CUTTING AND CAREER
DEVELOPMENT SET OF INVESTMENTS
REALLY FOCUSING ON BUILDING ON
THIS RESEARCH AS IT MOVES
FORWARD BOTH AT THE HUMAN LEVEL
AND THE RESEARCHER LEVEL AND
ALSO IN SOME OF OUR DATA AND
COLLABORATIVE EFFORTS COMING OUT
OF THE RESEARCH.
NEXT SLIDE, PLEASE.
AND ANOTHER WAY OF SHOWING KIND
OF WHERE WE ARE NOW IS OUR
OVERALL BALANCE BETWEEN OPIOID
ADDICTION AND OVERDOSE RESEARCH,
PAIN RESEARCH IN THE AREAS WHERE
THOSE CATEGORIES REALLY OVERLAP,
SO THAT'S SHOWN TO YOU ON THE
RIGHT.
OVER TIME WE'VE HEARD BOTH FROM
YOU AND FROM OUR EXTRAMURAL
COMMUNITY THAT IT'S REALLY
IMPORTANT TO CONTINUE TO SUPPORT
BOTH AREAS OF RESEARCH AND WHILE
THE ADDICTION FIELD WAS REALLY
READY TO GO IN CERTAIN ASPECTS
IN 2019, THE PAIN COMMUNITY IS
CONTINUING TO GROW AND SO
PROVIDING RESEARCH OPPORTUNITIES
TO SUPPORT THAT GROWTH.
WE'VE ALSO BUILT IN INTO OUR
RESEARCH PORTFOLIO A REAL FOCUS
ON CO-OCCURRING CONDITIONS THAT
INCLUDES MENTAL HEALTH
CONDITIONS RECOGNIZING THAT IN
REAL PEOPLE THESE CONDITIONS
COEXIST AND THAT OUR RESEARCH
SHOULD REFLECT THAT.
WE'VE INTEGRATED INTO OUR
OVERALL PORTFOLIO OF FOCUS ON
ADDRESSING STIGMA DIRECTLY
THROUGH RESEARCH AS WELL AS
RESEARCHERS CHOSE TO ADDRESS
INIQUITIES IN OUR HEALTHCARE
SYSTEM AND ACCESS TO HIGH
QUALITY CARE.
WE'VE DONE ALAN'S VIDEO WAS JUST
1 WAY THAT WE'VE SOUGHT TO LEARN
FROM THE VOICES OF LIVED
EXPERIENCE AND BUILT CONNECTION
BETWEEN PEOPLE WHO EXPERIENCE
PAIN AND ADDICTION AND THE
RESEARCH WE SUPPORT TOWARDS
PROVIDING THEM WITH SOLUTIONS.
WE HAVE SOUGHT TO LEVERAGE THE
POWER OF THE DATA COMING THROUGH
OUR RESEARCH INITIATIVES AND
ALSO TO SUPPORT TRAINING
OPPORTUNITIES AND EARLY CAREER
OPPORTUNITIES.
SO, ROB, CAN YOU GO BACK 1
SLIDE?
THIS IS REALLY THE OVER TIME
PERSPECTIVE IF YOU LOOK AT THE
CATAGORYS OF--
>>YEAH, IT'S YOU HAVE TO GO
BACK--LITTLE HARD TO KIND OF--
>>YEAH, THE RED AND ORANGE
TOGETHER ARE THE CLOSEST WE HAVE
TO PAIN BUT YOU DO SEE THE
PURPLE GROWING OVER TIME WHICH
ADDS NUANCE AS WELL.
OKAY, SO GOOD FORWARD 2 PLEASE?
ACROSS ALL OF THESE DIFFERENT
AREAS OF RESEARCH FOCUS, WE DO
HAVE CERTAIN CROSS CUTTING
THEMES THAT HAVE BEEN IN PLACE
AT THE BEGINNING AND THAT WE
HAVE REALLY EMBRACED AND PUT OUR
DEDICATED EFFORT INTO AS TD
INITIATIVE HAS EVOLVED.
FIRST LOOKING AT THE BIOLOGY OF
PAIN AND ADDICTION AND
LEVERAGING WHAT WE HAVE ALREADY
LEARNED AND WHAT WE ARE LEARNING
THROUGH ALL OF THESE NEW CUTTING
EDGE APPROACHES TO REALLY FOCUS
ON PAIN AND ADDICTION AND WHAT
WE CAN OFFER TO PEOPLE WITH
THOSE HEALTH CONDITIONS.
THAT BRINGS ME TO THE NEXT CROSS
CUTTING THEME FOCUSING ON THE
NEEDS OF THE WHOLE PERSON.
IN THE THIRD THEME HERE WORKING
WITH COMMUNITIES TO BRING
RESEARCH TO LIFE, WE HEARD FROM
YOU VERY EARLY ON THAT HEAL
WOULD NOT BE SUCCESSFUL IF WE
FOCUSED ONLY ON THE RESEARCH AND
THE RESEARCH PROJECTS.
WE NEEDED TO FIND THOSE THAT ARE
GOING TO HELP OUR RESEARCH
FINDINGS, WORK WITH THEM TO
TRANSLATE THEM AND BE PREPARED
TO MAKE CHANGES IN POLICY AND
PRACTICE BASED ON OUR RESEARCH
RESULTS AND THEN LASTLY BE VERY
REALISTIC AND UNDERSTAND THAT
THERE ARE SYSTEMIC INEQUITIES
AND CHALLENGES THAT KEEP OUR
RESEARCH ADVANCES FROM ACCESSING
PROVIDING BENEFIT TO ALL OF THE
COMMUNITIES WE SERVE AND SO
REALLY LOOKING AT THOSE SYSTEMIC
CHALLENGES AND TRYING TO ADDRESS
THEM WITH OUR RESEARCH.
SO NEXT SLIDE, PLEASE.
SO WHERE WE ARE TODAY IS REALLY,
I THINK AN INFLECTION POINT FOR
THE HEAL INIT WHYATIVE.
WE ARE BOTH LOOKING BACK OVER
WHAT WE'VE DONE AND ALSO LOOKING
FORWARD TOWARDS WHAT WE HOPE TO
BE ABLE TO DO AND TAKING A
MOMENT TO PAUSE AND KIND OF
CONSIDER IT ALTOGETHER.
ARE WE ACCOMPLISHING OUR CORE
GOALS AND ARE WE ADAPTING IN THE
RIGHT WAYS TO HAVE THE EVOLVING
DRIVERS, BOTH FOR PAIN AND
ADDICTION IN THE COUNTRY.
WHAT CHANGES ARE WE EXPERIENCING
AND ARE WE ABLE TO ADDRESS THEM
THROUGH OUR RESEARCH AND ARE WE
DOING THAT THE RIGHT WAY?
FOR THE PROGRAMS THAT WERE
LAUNCHED IN THAT LARGE FIRST
YEAR OF HEAL THERE NOW COMING TO
THE END OF THEIR FIRST PERIOD
AND WE HAVE TO DECIDE IN WHAT
WAYS THEY SHOULD CONTINUE AT
WHAT LEVEL, OR WITH WHAT AREAS
OF FOCUS.
AND AT THE SAME TIME WE'RE
CONSIDERING NEW AREAS OF
RESEARCH.
AND AT THE SAME TIME, LOOKING TO
BALANCE OUR OVERALL PORTFOLIO AS
WE HAVE FOR THE PAST COUPLE
YEARS BETWEEN ALL OF THESE
DIFFERENT ASPECTS AND ELEMENTS
OF THE SPECTRUM SO THAT WE
CONTINUE TO ADVANCE A NUMBER OF
DIFFERENT DIRECTIONS.
SO, I THINK THAT THAT'S KIND OF
A GOOD PLACE TO STOP AND ASK IF
THERE ARE QUESTIONS.
I HAVE A FEW MORE SLIDES LEADING
INTO THE NEXT DISCUSSION, BUT,
ARE ANY THOUGHTS OR QUESTIONS AT
THIS TIME?
OKAY, THEN, I WILL PROCEED.
NEXT SLIDE, PLEASE.
SO, SELECTED RESEARCH
ACCOMPLISHMENTS IS NEXT, SO LAST
WEEK YOU DID HEAR ABOUT AREAS
WHERE HEAL HAS LARGE PROGRAMS
THAT ARE MAKING PROGRESS, NOW
I'M JUST GOING TO CHERRY PICK
FROM A FEW DIFFERENT AREAS OF
RESEARCH FOCUS ACROSS THE
INITIATIVE AND TELL YOU ABOUT
WHAT ACCOMPLISHMENTS OUR
SCIENTISTS HAVE MADE OVER THE
PAST YEAR.
NEXT SLIDE.
HERE ARE ALL OF THE INCREDIBLE
SCIENTIFIC TEAMS, YOU KNOW THESE
FOLKS WELL, THE CO CHAIRS ARE
LISTED AND THE COLLABORATING
INSTITUTES AND CENTERS WHO
PARTICIPATEOT SCIENTIFIC TEAM
DEVELOPING AND CONDUCTING
RESEARCH ARE ALSO LISTED.
BIG THANK YOU TO ALL OF THESE
BRILLIANT INDIVIDUALS FOR THEIR
COMMITMENT AND HARD WORK.
NEXT SLIDE, PLEASE.
FIRST IN THE PRECLINICAL, AND
TRANSLATIONAL RESEARCH FOR PAIN
MANAGEMENT, THIS IS A VERY RICH
SLIDE IN TERMS OF DATA.
I WON'T GO THROUGH NAMING EACH
INDIVIDUAL PROGRAM, BUT WHEN I
SAID WE HAVE LAUNCHED OVER 40
PROGRAMS, HERE ARE THE 1S THAT
WE KIND OF REFER TO BY NAME AND
TALK ABOUT AND OUR INTERNAL
CONVERSATIONS AND SOMETIMES
REFLECTED IN THE NAMES OF OUR
FUNDING OPPORTUNITY
ANNOUNCEMENTS AND YOU CAN SEE
FROM THIS SLIDE, WHEN THEY WERE
LAUNCHED, SO SOME OF THESE
PROGRAMS WERE LAUNCHED AT THE
VERY BEGINNING OF HEAL IN 2018,
2019.
SOME TOOK MORE TIME IN CERTAIN
CASES, WE HEARD DIRECTLY FROM
YOU ALL AND WE SAID WE HAVE TO
MAKE SURE THAT WE CONTINUE TO
SUPPORT RESEARCH AND ANALGESIC
DEVELOPMENT AND THAT BECAME SOME
OF THE NEW ADDITIONS TO THE
OVERALL PORTFOLIO AND THEN AT
THE VERY BOTTOM, HERE ARE THE
LIGHTER BLUE COLOR, ARE THE
PROGRAMS THAT ARE PROPOSED FOR
THE UPCOMING FISCAL YEAR, FISCAL
YEAR 24.
SO YOU WILL HEAR LATER TODAY IN
MORE DETAIL ABOUT THOSE SPECIFIC
PROGRAMS AND WHY THE LEADS OF
THE SCIENTIFIC TEAM BELIEVE THAT
NOW IS THE RIGHT TIME TO ADD
THEM TO THIS PORTFOLIO, AND HOW
THEY WILL FILL IMPORTANT GAPS.
SO NEXT SLIDE, PLEASE.
THROUGH ALL OF THESE DIFFERENT
RESEARCH PROGRAMS WE'VE REALLY
MADE INCREDIBLE PROGRESS AND
SOME OF THESE INVOLVE DIFFERENT
WAYS TO CREATE OR WORK IN THE
LAB TO ADVANCE THERAPEUTIC
DEVELOPMENT BY CREATING CERTAIN
TYPES OF CELLS.
MODELS OF THE BODY, MODELS OF
DIFFERENT DISEASE CONDITIONS AND
THEN LIBRARIES OF TARGETS AND
COMPOUNDS TO TEST THROUGH THESE
MANY DIFFERENT MODEL SYSTEMS TO
BETTER ACCELERATE THE
DEVELOPMENT OF NOVEL TREATMENTS
FOR PAIN.
NEXT SLIDE, PLEASE.
NOW IN THE CLINICAL SPACE, YOU
SEE ALL THE DIFFERENT PROGRAMS
IN THE DARKER BLUE THAT WE HAVE
LAUNCHED OVER THE YEARS AND THEN
IN THE LIGHTER COLOR, WHAT IS
PROPOSED FOR THIS UPCOMING
FISCAL YEAR AND THEN FOLLOWING
SLIDE,--
>>CAN I ASK A QUICK QUESTION.
>>YES, GO AHEAD.
>>ON THE TIMELINES WHICH ARE
HELPFUL AT THE END OF THE ERA IS
IT TELLING US SOMETHING ABOUT
[INDISCERNIBLE] AND THINGS LIKE
THAT?
>>WELL, IT MOSTLY REFLECTS WHAT
WE HAVE COMMITTED TO FUNDING AT
THIS TIME.
SO IF SOMETHING IS ENDING IN THE
FUTURE, THAT DOESN'T REALLY MEAN
TOO MUCH BECAUSE WE HAVEN'T HAD
A CHANCE TO DISCUSS IT, EVALUATE
ITS PROGRESS AND EVALUATE
WHETHER IT WILL CONTINUE.
IT CERTAINLY DOESN'T MEAN
THEY'RE EXPECTED TO END.
IF YOU GO BACK 2, PLEASE.
TWO SLIDES PLEASE, YEAH, SO YOU
CAN SEE HERE SOME OF THE 1S THAT
ARE SHOWN ENDING IN 2024, THESE
ARE THE 1 1S THAT WE TALKED TO
LAST WEEK BECAUSE THEY'RE THE 1S
WE'RE CONSIDERING HOW BEST
CONTINUE.
SOME OF THE PROGRAMS THAT ENDED
EVOLVED INTO OTHER PROGRAMS, SO
FOR INSTANCE IF YOU SEE DEVICES
FOR PAIN, YOU REALIZE THAT WE
HAVE KIND OF SUPPLEMENTED OR
ADDED TO THAT RESEARCH THROUGH
CLINICAL TRANSLATION BY
BLUEPRINT AND TRANSLATIONAL
DEVICE DEVELOPMENT SO THAT
PROGRAM WE DON'T REALLY SEE AS
ENDING BUT RATHER HAVING EVOLVED
INTO A DIFFERENT SET OF PROGRAMS
BUT FOR THOSE THAT HAVEN'T
REALLY GONE THROUGH THAT
PROCESS, A SUBSET OF THOSE ARE
NOW AT THE POINT THAT WE TALK TO
YOU ABOUT THEM LAST WEEK AND A
SUBSET OF THEM IF YOU GO
FORWARD, 2 MORE, 2 SLIDES BACK
TO WHERE WE WERE, THESE PROGRAMS
BECAUSE THEY'RE CLINICAL TRIALS
AND CLINICAL TRIALS OFTEN LAST A
LITTLE BIT LONGER THAN
ORIGINALALLY ENVISIONED BY THE
RESEARCHERS ESPECIALLY WHEN
COVID AND SOME OF THE ARE
INTERRUPTIONS TO THE CLINICAL
SITES THAT DO THIS RESEARCH SO
OVER THE PAST COUPLE YEARS,
THESE ARE NOT AT A DECISION
POINT, THEY HAVE NOT YET
RELEASED THEIR FINDINGS, WE HAVE
GOTTEN TO A POINT WE CAN
DETERMINE AND HOW AND AT WHAT
LEVEL AND CONDITION THEY SHOULD
CONTINUE.
SORRY, SO THAT'S WHY THESE ARE
REALLY NOT BEING BROUGHT FORWARD
FOR DISCUSSION AS PART OF THE
ONGOING RESEARCH OF THE
POPULATION.
>>I WAS THINKING ABOUT
BALANCING IN TERMS OF
CONSIDERING THE NEW PROGRAMS AND
UNDERSTANDING ITS 0-SUM-GAIN
NATURE AND WHAT IT IS.
>>THAT'S VERY SMART OF YOU
BECAUSE WE HAVE LAUNCHED A LOT
AND WE CAN'T YOU KNOW CONTINUE
TO LAUNCH AND LAUNCH AND LAUNCH,
THINGS WILL NEED TO SUN SET IF
WE CONTINUE TO LAUNCH NEW
THINGS.
AND THAT IS PART OF THE OVERALL
BALANCE DISCUSSION THAT WE WILL
HAVE.
I THINK--ARE THERE ANY MORE
QUESTIONS RIGHT NOW?
>>THEN WE CAN CONTINUE, NEXT
SLIDE, PLEASE TO SOME OF THE
ADVANCES IN RESEARCH AND
CLINICAL PAIN MANAGEMENT.
WE HAVE A LOT OF RESEARCH
COMPARING DIFFERENT APPROACHES,
ESPECIALLY COMPLIMENTARY AND
NONPHARMAICOLOGGICCAL APPROACHES
FOR BEHAVIOR MANAGEMENT SUCH AS
COGNITIVE BEHAVIORIAL THERAPY,
INCLUDING MODALITIES NOW AND
THIS IS REALLY VALUABLE RIGHT
NOW, THE TELEHEALTH AND VIRTUAL
APPROACHES ARE REALLY TAKING
OVER FOLLOWING COVID.
WE HAVE RESEARCH SUPPORTING
PROVIDER PATIENT CO-DECISION
MAKING FOLLOWING CAESAREAN
SECTION, A VERY COMMON
PROCEDURE, RESULTING IN OPIOID
PRESCRIPTIONS.
MINDFULNESS BASED, RELAPSE
PREVENTION, IN COMBINATION WITH
MEDICATION FOR THE TREATMENT.
--DISCOVER WAYS TO INFORM
PATIENTS OF WAYS TO TREAT
CHRONIC BACK PAIN, ALL OF THIS
WITH FULL PERSON AND
PATIENT-CENTRIC CARE.
MOVING ALONG TO THE NEXT SLIDE,
HERE IS OUR TRANSLATION OF
RESEARCH FOR PRACTICE FOR THE
TREATMENT OF OPIOID USE DISORDER
AND YOU CAN SEE 3 OF THE
PROGRAMS THAT WE TOLD YOU ABOUT
LAST WEEK AS WELL AS SOME OTHERS
THAT HAVE BEEN LAUNCHED OVER THE
YEARS.
NEXT SLIDE PLEASE.
SOME PROGRESS IN THIS AREA, YOU
MAY HAVE ALREADY HEARD THROUGH
THE JUSTICE COLLABORATIVE OPIOID
INNOVATION PROGRAM NETWORK OR
J-YOIN COIN RESEARCH ON MAKING
MEDICATION BASED TREATMENT FOR
OPIOID USE DISORDER AVAILABLE IN
MASSACHUSETTS RURAL JAILS, FOUND
THAT ACCESS TO MEDICATION FOR
THE TREATMENT OF OPIOID USE
DISORDER, REDUCED REARREST.
THEY'VE ALSO REALLY BUILT THE
RELATIONSHIPS WITH JAILS AND
DECISION MAKERS IN THE JUSTICE
SETTING TO PROMULGATE AND SHARE
THIS INFORMATION TO INFORM OTHER
TREATMENTS AND DECISIONS AND
NEXT SLIDE, PLEASE.
IN THE AREA OF PREVENTION AND
TREATMENT FOR OPIOID USE
DISORDER, YOU CAN SEE ALL THE
THINGS WE STARTED WITH IN 2019
INCLUDING THE PORTFOLIO YOU
HEARD ABOUT FROM AMY LAST WEEK
AND THE MANY DIFFERENT PROGRAMS
WE HAVE LAUNCHED SINCE THEN.
NEXT SLIDE, PLEASE.
THERE HAS BEEN A LOT, A LOT OF
RESEARCH UNDERWAY, A LOT OF IT
THROUGH THE NIDA CLINICAL TRIALS
NETWORK, INCLUDING RETROSPECTIVE
ANALYSIS, INFORMING HOW
CLINICIANS CAN SUPPORT
INDIVIDUALS ON BUPRENORPH FOR
THE TREATMENT OF OPIOID USE
DISORDER.
IT'S COMMON FOR PEOPLE TO WANT
TO OR FEEL PRESSURE TO
DISCONTINUE THIS TREATMENT
INFORMING CLINICIANS ABOUT THE
RISKS OF FOLLOWING
DISCONTINUATION OF THE TREATMENT
OF BUPRENORPHINE DISORDER AND
THAT WILL BE FOLLOWED BY ONGOING
RESEARCH ON HOW TO BEST SUPPORT
HAVE INDIVIDUALS WHO DO
DISCONTINUE THIS TREATMENT.
NEXT SLIDE, PLEASE.
IN THE SPACE OF NOVEL
THERAPEUTIC OPTIONS, VISIT AS
YOU SAW THE BEGINNING A REALLY
SIGNIFICANT POINT OF EMPHASIS
FOR HEAL, WE REALLY KNOW THESE
MEDICATIONS CAN BE LIFE SAVING
AND ALTHOUGH WE HAVE MULTIPLE
LIFE SAVING MEDICATIONS WE WANT
MORE AND MORE EASIER FRIENDLY
VERSIONS OF THEM, NEXT SLIDE,
PLEASE.
WE'VE SUPPORTED A LOT OF
INNOVATION IN THIS SPACE, MANY
FORMS OF MOUD, AS WELL AS
DEVICES AND FIRST IN HUMAN
TESTING OF A VACCINE FOR
INDIVIDUALS WITH OPIOID USE
DISORDER.
NEXT SLIDE, PLEASE.
VACCINE TO PREVENT OVERDOSE, AND
LASTLY IN THE SPACE OF OUTCOMES
FOR ENHANCED OUTCOMES IN INFANTS
AND CHILDREN, LARGE PROGRAMS
FOCUSING ON THE BRAIN AND
DEVELOPMENT OF CHILDREN EXPOSED
TO OPIOIDS AND OTHER SUBSTANCES
AS WELL AS CLINICAL TRIALS
FOCUSING ON BEST WAYS TO TREAT
INFANTS EXPOSED TO OPIOIDS.
NEXT SLIDE, PLEASE EMPLOY I
THINK THE EAT-SLEEP-CONSOLE IS
WINDING DOWN AND LIKELY TO GIVE
US INTERESTING FINDINGS AROUND
THAT PARTICULAR ASSESSMENT TOOL
FOR INFANTS BORN TO THOSE WITH
SEVERENYONATAL OPIOID
WITHDRAWAL, SYNDROME OR NOWS AND
THEY'RE MEASURING HOW MUCH TIME
THESE INFANTS ARE IN THE
HOSPITAL AND HOW MANY OPIOIDS
THEY'RE EXPOSED TO SO PLEASE
LOOK FORWARD TO THOSE RESULTS
AND NEXT SLIDE, PLEASE.
AND HERE WE ARE, RESEARCH UNDER
CONSIDERATION, SO ALL OF THAT IS
KIND OF WHAT'S ONGOING, WHAT'S
HAPPENING ALREADY AND WHAT
YOU'VE SEEN BEFORE, NOW, TO KIND
OF THE IMMEDIATE NEXT TOPIC ON
OUR AGENDA, RESEARCH UNDER
CONSIDERATION.
NEXT SLIDE, PLEASE.
AND I THINK YOU WILL HEAR IN
QUITE A BIT OF DETAIL FROM THE
CO CHAIRS OF THE SCIENTIFIC
TEAMS ON EACH OF THESE CONCEPTS,
THEY WERE SHARED WITH YOU
ELECTRONICALLY IN A LOT MORE
DETAIL THAN WE WILL GO OVER IN
THE SLIDES.
SO IF YOU DON'T HAVE THOSE
PACKETS OR ANYTHING HANDY,
PLEASE LET US KNOW.
BUT HERE IS WHAT HAS BEEN
PROPOSED BY THE SCIENTIFIC TEAMS
FOR 2024, THE NEXT YEAR WE'RE
CONSIDERING RESEARCH IDEAS ON
THE PRECLINICAL SIDE, REALLY
SEEKING TO UNDERSTAND
DIFFERENCES AMONG HUMANS AND
PAIN CONDITIONS, AND THEIR
CO-MORBIDITIES WELL AS WELL AS
THINGS THAT PEOPLE HAVE BEEN
EXPOSED TO AND THE CLINICAL
SIDE, LOOKING AT PEDIATRIC PAIN
CONDITIONS AND BEST WAYS TO
TREAT AND UNDERSTAND THOSE AS
WELL AS SOME WORKFORCE MED
TECHS, SLEEP, AND BIOMARKER
FOCUSED RESEARCH.
NEXT SLIDE, PLEASE.
AND WITH THAT, I THINK I WILL
TURN IT OVER TO IT IS EXPERTS
BUT BEFORE I DO SO, WALTER ARE
YOU STILL WITH US AND
APPROXIMATE WOULD YOU LIKE TO
SAY ANYTHING BEFORE I HAND IT
OVER TO CHRISTINE AND MICHAEL?
>>WELL, I HESITATE TO SAY
ANYTHING BECAUSE I THINK I SAID
IT ALL BEFORE BUT CERTAINLY FOR
PAIN HEAL HAS CHANGED THE WHOLE
LANDSCAPE OF PAIN RESEARCH AT
NIH AND SO I THINK WE'VE DONE
SOME GOOD THINGS BUT IESM
LOOKING FORWARD TO DOING BETTER
THINGS IN THE FUTURE AND THAT'S
WHERE THE PLRKS DWG COMES IN AND
GIVING US ADVICE ON HOW TO
ALWAYS GET BETTER.
SO THAT'S MY SPEIL AND I'M
STICKING TO IT.
>>EXCELLENT.
THANK YOU.
SO I SEE MICHAEL OSHINSKY.
WILL YOU LEAD US THROUGH?
>>THANK YOU SO MUCH REBECCA AND
GREETINGS TO THE MDWG, AGAIN AND
I WANT TO THANK YOU FOR HELP AND
ADVICE ON PUT ON THE INITTIAIVE
ITS WE BROUGHT FORWARD TO YOU IN
THE PAST AND TODAY WE WILL BE
BRINGING FROM THE PRECLINICAL
AND TRANSLATIONAL RESEARCH AND
PAIN MANAGEMENT WORK GROUP, 2
INITIATIVES WE'RE LOOKING FOR
YOUR FEEDBACK AND ADVICE ON
RELATED TO PAIN AND PAIN
MANAGEMENT.
NEXT SLIDE.
I THINK IT'S IMPORTANT TO START
WITH THIS DOCUMENT AND THANK YOU
FOR YOUR COMMENTS, EARLIER ROB
RELATED TO, YOU KNOW WHEN
PROGRAMS HAVE STARTED AND STOPS,
ET CETERA, YOU CAN SEE HERE THAT
THERE ARE A LOT OF ONGOING
PROGRAMS INSIDE THE PRECLINICAL
AND TRANSLATIONAL RESEARCH AND
PAIN RESEARCH WORK GROUP INSIDE
OF HEAL.
SOME OF THEM HAVE STARTED RIGHT
AT THE BEGINNING OF HEAL, SUCH
AS THE TARGETS DISCOVERY AND
VALIDATION AND SOME OF THEM ARE
VERY NEW AND IT'S JUST, IF YOU
LOOK AT THE BOTTOM OF THE SLIDE,
JUST GOTTEN SOME RECENT
APPLICATIONS ASSOCIATED WITH
THEM AND WE'RE IN THE PROCESS OF
EVALUATING THEM, ET CETERA AND
THEN WAY AT THE BOTTOM OF THE
SLIDE, YOU SEE 2 NEW ADDITIONAL
INITIATIVES THAT WE'RE BRINGING
BACK FOR YOUR FEEDBACK, 1 OF
THEM IS INDIVIDUAL DIFFERENCES
IN HUMAN PAIN CO-MORBIDITIES AND
THE CHECKANISTIC EXPOSOME ON
ACUTE ASK CHRONIC PAIN.
SO IN THE CONTEXT OF DEVELOPING
NEW INITIATIVES, WHAT WE'RE
LOOKING FOR IS THE FILLING GAP,
WHAT THE WORK GROUP IS FOCUSED
ON, AND WE'RE ALSO INTERESTED IN
DEVELOPING INITIATIVES, THAT ARE
NOT GAPS IN HEAL BUT GAPS IN THE
WAY OR THE TYPE OF RESEARCH THAT
IS DONE ACROSS ALL THE NIH,
INSTITUTES.
SO DEVELOPING INITIATIVES, THAT
REALLY REQUIRE THE INPUT FROM
MULTIPLE INSTITUTES AND THE
INITIATIVE ITSELF WOULDN'T SEE
IT INTO 1 PARTICULAR INSTITUTE.
IT'S SOMETHING THAT NEEDS THE
COLLABORATION FROM MANY NIH
INSTITUTES AND ICs AND THE
EXPERTISE THAT THEY BRING TO THE
GROUP.
SO I HOPE YOU LOOK AT THOSE,
THESE INITIATIVES THAT WE'RE
BRINGING FORWARD FROM THAT
PERSPECTIVE.
NEXT SLIDE.
SO THIS IS A COMMON DIAGRAM
WE'VE SHOWED YOU BREFLY, AND I
WILL GO THROUGH THIS QUICKLY AND
SHOW THE NEW INITTIAIVE ITS, SO
FROM THE TOP OF THE DIAGRAM,
FROM DISCOVERY TO PRECLINICAL TO
CLINICAL AND IMPLEMENTATION AND
DISSEMINATION, YOU SEE THE BREAK
UP OF THE PRECLINICAL WORK
THAT'S DONE IN LIGHT BLUE AND
THE 1S THAT ARE IN GRAY FALL
INTO THE CLINICAL PAIN RESEARCH
WORK GROWP THAT'S KIND OF HOW
THAT'S BROKEN UP HERE AND WHY
THERE'S 2 SEPARATE COLORS OVER
THERE.
WHEN SEE SEE THESE, WE DEVELOP
THESE PROGRAMS AT THE TOP LEFT
OF THE SLIDE FOR THERAPEUTIC
DEVELOPMENT TARGET DISCOVERY AND
VALIDATION, FOR INTERNAL AUDIT I
SHALL ANALGESIC DEVELOPMENTS
STUDY TO FEED INTO THE PAIN
THERAPEUTIC DEVELOPMENT PROGRAM
WHICH BRINGS THOSE GROUPS TO
THEIR IND FILING AND THEN OF
COURSE PHASE 1 CLINICAL TRIAL
WHICH WAS SO ESSENTIAL; AND THE
SUPPLEMENT PROGRAM LIKE THE
COLLABORATION FOR PAIN AND THEN
OF COURSE THE MECHANISMS OF
DEVICE BASED RELEASE, IT'S NOT
JUST SMALL BIOLOGICS BUT WHAT
ARE WE LOOKING AT HERE,
INDIVIDUAL DIFFERENCES OR
LOOKING AT ACTORS THAT
CONTRIBUTE TO PAIN WHICH COULD
SEE THE OUTPUT OR EFFECTIVENESS
OF INTERVENTIONAL PAIN
THERAPIES, THESE SMALL MOLECULES
AND DEVICES ARE ABLE TO
INTERVENTIONS AND THAT IS--THOSE
ARE THE GAPS FROM A THERT
THOUSAND PETE THAT WE'VE
IDENTIFY THAD WE WANT TO PRESENT
TO YOU TODAY.
AND I WILL HIGHLIGHT 1 MORE TIME
THE SMALL BUSINESS PORTFOLIO
WHICH REALLY HAD DOZENS OF
COMPANIES TRYING PRODUCE PROD
UBTS TO TREAT PAIN IN THE ARENA
WHICH IS ESSENTIAL FOR THE
TREATMENT.
NEXT SLIDE.
ALL RIGHT, SO LET'S REALLY
IDENTIFY THE PROBLEM FIRST. AND
WHAT THIS IS TO FILL OR GAP
HERE, THAT IS THAT INDIVIDUAL
DIFFERENCES IN PAIN EXPERIENCE
COMPLICATE PROVIDING EFFECTIVE
PAIN MANAGEMENT.
I THINK WE ALL AGREE WITH THIS
AND THIS WAS ACTUALLY IDENTIFIED
IN THE IPRCC, THE WORK THAT THEY
DID, IDENTIFYING GAPS OR THE OR
A FEDERAL PLAN FOR RESEARCH IN
THE PAIN ARENA AND IT'S
UNDERSTANDING INDIVIDUAL
DIFFERENCE AND PERSONS LIVED
WITH PAIN.
SO FILLING THIS GAP IS REALLY
THE GOAL OF THIS INITIATIVE AND
TO DO THAT IS TO ADDRESS
INDIVIDUAL DIFFERENCES IN THE
IDEA OF FULL PERSON HELT THROUGH
THE CLINICAL AND/OR PRECLINICAL
DATA TO UNDERSTAND THE MECHANISM
TO ENABLE EVIDENCE-BASED
MODELING OF THIS DATA OF CO
EXISTING CONDITIONS, CO EXISTING
SUBSTANCE USE BE IT OPIOID,
STIMULANTS, CONTROL, ET CETERA
ALONG WITH THOSE PATHOLOGICAL
PAIN CONDITIONS SO THAT WE CAN
ANSWER THE QUESTION, WHICH TYPE
OF PATIENT ARE APPROPRIATE FOR
CERTAIN TYPES OF TREATMENTS AND
ARE THERE GROUPS OF
CO-MORBIDITIES OR CO EXISTING
CONDITIONS THAT LEAD THE PATIENT
TO HAVING INCREASED SUSCEPTIBLE
TO INTENSE PAIN OR RESISTANCE TO
TREATMENTS, ET CETERA.
SO THE GOAL IS TO COLLECT
CLINICAL DAT OF THEIR PAIN AND
THEIR PAIN CONDITIONS IN
INDIVIDUALS WITH 2 OR MORE PAIN
CONDITIONS ALONG WITH THEIR
MENTAL HEALTH CONDITIONS OTHERS
OTHER PHYSICAL HEALTH
CONDITIONS, THEIR SUBSTANCE
ABUSE, AND ET CETERA AND THEN
PRODUCE THESE MODELING
EXPERIMENTS OR STUDIES TO
UNDERSTAND THE PLEKANISMS OF THE
INTERACTING OF THOSE COMORBID
CONDITIONS, RIGHT?
AND THE GOAL AGAIN IS TO
ACCELERATE THE DEVELOPMENT OF
TARGETED, AND THAT'S THE FOCUS
HERE, ON THESE INDIVIDUALS OF
THE PAIN THERAPIES AND PAIN
MANAGEMENT STRATEGIES, RIGHT?
AGAIN, NOT SPECIFIC FOR
MOLECULAR DEVICES OR BIOLOGICS
OR BEHAVIORIAL INTERVINGZS AND
ALL THAT IS INCLUDED BUT
HOPEFULLY WE CAN INFORM PATIENTS
WHAT'S BEST FOR THEM.
AND IS NOT, I WANT TO MAKE IT
REALLY CLEAR, THIS IS NOT A
BIOMARKER IN THIS, ALL RIGHT.
THAT'S THE FIRST INITIATIVE.
SECOND 1, NEXT SLIDE, PLEASE,
I'M SORRY THERE'S MORE DETAIL ON
THIS 1.
SO HOW DOES THAT FIT AND
COMPLEMENT OTHER HEAL PROGRAMS,
SO UNDERSTANDING INDIVIDUAL
DIFFERENCES AND PERSONS WITH
LIVED PAINS AND CO-MORBIDITIES
IS REALLY A FOCUS OF MANY OF THE
HEAL PRECLINICAL AND
TRANSLATIONAL AND CLINICAL
INITIATIVES, SO INFORMING THOSE
WITH THE DATA SETS THAT WILL
COMPLEMENT THE WORK IN THOSE
PARTICULAR INITIATIVES, TOO.
THIS DATA CAN ALSO BE USING FOR
BACK TRANSLATING AS A
PRECLINICAL MODEL AND UNDERSTAND
HOW THESE CO-MORBIDITIES ARE
INFLUENCING PAIN OR THE RESPONSE
TO TREATMENT.
AND THEN, CENTRAL TO THE NIH
HEAL INITIATIVE, THE OVERALL
GOAL IS OKAYING AT THE IMPACT OF
SUBSTANCE USE, OPIOID USE,
STIMULANTS, ALCOHOL, ET CETERA
AND ON MENTAL HEALTH ON THE
EXPRESSION OF PAIN.
AND THERE'S A WHOLE LIST OF THE
PROGRAMS THAT THIS COULD
INTERACT WITH OF COURSE, THERE'S
BEEN REJOINED, BACP A C AND THE
PATIENTS THAT WE'RE RECRUITING
INTO EPPIC-NET, ET CETERA, ET
CETERA SO THIS COULD FORM A LOT
OF DIFFERENT PROGRAMS.
>>MICHAEL?
>>YES, PLEASE,AL AN?
>>JUST CURIOUS, I THINK THIS
FITS IN, BUT SO IF YOU'RE--IS
DEPRESSION CONSIDERED A COMORBID
CONDITION.
>>YES.
>>SO IT WOULD BE HERE, OKAY,
THANK YOU.
>>NO PROBLEM.
GREAT QUESTION.
NEXT SLIDE.
SO HERE'S A FEW QUESTIONS THAT
WE LAID OUT TO GET FEEDBACK FROM
THE MDWG ASSOCIATED WITH THIS
FIRST INITIATIVE.
ARE THERE SPECIFIC COMORBID
OCCURRING CONDITIONS SUCH AS
ALAN MENTIONED LIKE DEPRESSION
THAT WE SHOULD BE LOOKING AT OR
FOCUSING IN HERE AND MAYBE, YOU
KNOW FOCUS A PROGRAM AROUND
THOSE AS OPPOSE TO A GENERAL
OPEN CALL, AND CAN THEY HELP US
INFORM WHAT WE'RE SEEING IN
OTHER HEAL CONDITIONS, WILL IT
BE POSSIBLE TO EXAMINE THESE
INDIVIDUAL DIFFERENCES MAYBE IN
RECOVERY, AND INCLUDE THOSE
THERE, TOO SUCH AS ENVIRONMENTAL
SOCIAL FACTORS AND THEN WHAT
SPECIFIC POPULATIONS WOULD IT BE
HELPFUL TO PRIORITIZE, SOME
EXAMPLES OF THAT ARE USHED
REPRESENTED GROUPS, MARGINALIZED
GROUP OR POPULATIONS WITH HEALTH
DISPARITIES AND GO AHEAD, ROB,
WE'RE READY.
>>OKAY, THANK YOU.
SO THESE QUESTIONS KIND OF
ADDRESS WHAT OCCURRED TO ME AS I
WAS READING THESE 2 CENTRAL
PROGRAMS WHICH TO ME IT'S
UNCLEAR WHERE THE LINE BETWEEN
INDIVIDUAL DIFFERENCES AND
TRYING TO REMEMBER THE TERM FOR
THE NEXT 1, EXPOSE OHM, BECAUSE
A LOT OF WHAT YOU'RE TALKING
ABOUT HEAR SHOULD ENVIRONMENTAL
OR SOCIAL FACTORS BE INCLUDED,
DOESN'T THAT FACTOR INTO THIS
EXPOSOME THING?
SO FIRST OF ALL OVERALL I THINK
THE NOTION OF USING THESE BIG
DATA SETS AND BRINGING IN ALL
THESE FACTORS TO REALLY LOOK AT
OUTCOMES I THINK IS VERY
IMPORTANT.
AND I THINK THE FIELD IS READY,
THE TECHNOLOGY IS THERE AND
THERE ARE PEOPLE SORT OF WORKING
ON THIS ALREADY AND THERE'S NOT
A GREAT FIT OR FUNDING FOR THAT
TYPE OF WORK, SO I THINK THIS IS
A GOOD, GOOD THING TO ADDRESS, I
JUST WONDER IF THESE ARE
ACTUALLY 2 SEPARATE PROGRAMS,
JUST FOR THE GENERAL
CONVERSATION AS WE GO THROUGH
THESE 2 THINGS, ARE THESE SORT
OF PART AND PARCEL THE SAME
THING, AND WE SHOULD BE ASKING
THESE QUESTIONS, BIGGER OR IS
THERE A SPECIFIC REASON TO FOCUS
ON THE EXPOSOME?
>>I THINK THAT'S A GREAT
QUESTION AND YOU READ IT JUST
LIKE OUR WORK GROUP DISCUSSED
IT.
AND THAT'S WHY THERE'S THIS
EMPHASIS TO THE CLINICAL DATA
SET, IN THE FIRST INITIATIVE TO
KIND OF GET THAT DATA AND THE
SECOND 1 IS A MECHANISTIC
UNDERSTANDING OF THINGS THAT
HAVE BEEN IDENTIFIED AND WE HAVE
GOOD AND YOU KNOW LITERATURE,
PUBLISHED ON IT LIKE YOU
MENTIONED IN THIS AREA, LIKE
SLEEP AND PAIN AND EXPOSOME, AND
I KNOW I'M JUMPING AHEAD BUT
THAT'S A MECHANISTIC INITIATIVE
AND THIS 1'S MORE GATHERING DATA
AND FACTORS AND FOLLOWING INTO
GROUPS.
I HOPE THAT HELPS.
>>YEAH, I THINK SO BUT WE CAN
DISCUSS IT FURTHER.
ONE OF THE THINGS THAT COMING TO
MIND IN TERMS OF POPULATIONS IS
TO THINK ABOUT, BECAUSE WHAT
THIS TYPE OF WORK IS GOING TO
RELY ON IS LARGE, EMR SYSTEMS
AND WHO ARE WE MISSING AT THE
POPULATION LEVEL, YOU KNOW MAYBE
THOSE DATA SETS, I MEAN MAYBE
WE'RE NOT CAPTURING DATA BROADLY
FROM RURAL COMMUNITIES OR FROM
POORER COMMUNITIES THAT'S
SOMETHING WE CAN CONSIDER AND
THAT'S PROBABLY KNOWN.
I DON'T KNOW WHAT THAT IS BUT
I'M JUST MINDFUL OF THE--IF
WE'RE LOOKING, WHERE WE'RE
PLUGGED IN DATA WE MIGHT BE
MISSING LARGE SWATHS OF PEOPLE.
>>EXCELLENT SUGGESTION.
GO AHEAD, CHRIS.
>>THANKS, MICHAEL.
OBVIOUSLY I'M A LITTLE BIASED
HERE BUT IESM IN GREAT SUPPORT
OF THIS TYPE OF PROGRAM
PARTICULARLY FROM THE WHOLE
PERSON HEALTH APPROACH WHICH I
THINK IS VITAL GIVEN WHAT WE'VE
LEARNED THROUGH HEAL AND
PROBABLY KNEW A BIT BEFORE THEN
THAT, YOU KNOW THESE THINGS DO
NOT OCCUR IN ISOLATION, RIGHT?
AND SO IF WE'RE REALLY GOING TO
BE ABLE TO TRANSLATE AND PROVIDE
GOOD CLINICAL CARE AND
THERAPEUTIC INTERVENTIONS, YOU
REALLY NEED TO TAKE THESE THINGS
INTO CONSIDERATION AS THEY
OCCUR.
CRITERIA YOU KNOW IN PEOPLE.
IN REGARDS TO THE FIRST
QUESTION, JUST A COUPLE
SUGGESTIONS, THERE ARE, YOU KNOW
NIH FUNDED STUDIES AND
INVESTIGATORS THAT HAVE ALREADY
LARGE DATA SETS ISSUE LOOKING
AT, 1 IS SEAN MACKEY, THE
REGISTRY HE HAS AT STANFORD,
DAVE CLAW AND WILLIAMS AT
UNIVERSITY OF MICHIGAN, THE BACP
A C IS USING THE COPE SCREENING
TOOLS AND THEN YOU ALL HAVE
GIVEN COPE SUPPLEMENTS TO LOOK
AT LARGE DATA SETS SO I THINK IT
WILL BE REALLY INTERESTING TO
THE EXTENT THAT THE DATA IS
AVAILABLE TO BE ABLE TO DO, YOU
KNOW QUICK ANALYSIS, PRELIMINARY
ANALYSIS AND SEE WHAT THOSE
SPECIFIC COMBINATIONS OF CO
OCCURRING CONDITIONS ARE THAT
WILL HELP YOU REALLY TO BETTER
INFORM WHERE YOU MIGHT WANT TO
FOCUS OR WHETHER THERE'S TRENDS
THAT CAN BE IDENTIFIED.
AND THEN THE OTHER QUESTION,
THAT'S 1 COMMENT.
AND THEN THE QUESTION I HAD
ABOUT BIOMARKERS WAS, I
UNDERSTAND THIS IS NOT A
BIOMARKER PROGRAM, RESEARCH
PROGRAM BUT WILL YOU ACCEPT
PROFOAZALS THAT POTENTIALLY HAVE
A BIOMARKER COMPONENT, EVEN IF
IT'S NOT THE MAJORITY OF IT
BECAUSE THE REASON WHY I ASK
THAT IS JUST BECAUSE THERE'S
SUCH A GREAT NEED TO UNDERSTAND
BIOPSYCHOSOCIAL BIOMARKERS IN
TERMS OF PREDICTABILITY OF WHICH
PATIENT POPULATIONS
PARTICULARLY, THOSE WITH CO
OCCURRING CONDITIONS, PROGRESS
TO GET BETTER OR PROGRESS TO GET
WORSE AND WHAT THOSE
INTERVENTIONAL FACTORS MAY BE UP
FRONT.
THERE'S BEEN A COUPLE FUNDED
THROUGH THE ACTUAL BIOMARKER
PROGRAM BUT WE KNOW SO LITTLE
ABOUT THIS I JUST WONDER IF THAT
WILL BE ACCEPTED AS PART OF THE
RESEARCH PROGRAM OR WHETHER
THEY'RE COMPLETELY NOT ALLOWED.
>>SO WE HAD THIS DISCUSSION,
OBVIOUSLY, THAT'S WHY I PUT IT
ON THE SLIDE AND IT'S GREAT THAT
YOU BROUGHT IT UP AND YOUR SHOW
OF SUPPORT FOR BIOMARKERS IN
THIS AREA AND THE CONSISTENT
SUPPORT FROM THIS AREA FROM THE
MDWG WE HEAR IT REALLY LOUD AND
CLEAR, IT'S THAT THIS PARTICULAR
INITIATIVE, IF WE INCLUDE IT
BIOMARKER STUDIES THAT THAT
COULD EITHER DILUTE THE WORK
THAT'S BEING DONE AND THE FOCUS
WE HAVE HERE, AND ALSO NOT BE
PROPER BIOMARKER, YOU KNOW
VALIDATION OR DISCOVERY WORK.
SO WE FELT THAT THOSE SHOULD BE
INDEPENDENT APPLICATIONS AND
EVALUATED FROM THE QUALITY OF
THE EXPERIMENTS TO DEVELOP THAT
BIOMARKER AND NOT JUST DILUTE IT
AND SPLIT IT INTO 2 DIFFERENT
TYPES OF RESEARCH.
SO I HOPE THAT HELPS.
WE DO HEAR YOU LOUD AND CLEAR
THAT BIOMARKERS AND PAIN ARE
ABSOLUTELY IMPORTANT AND WE'RE
NOT TRYING TO TAKE AWAY FROM
THAT WITH THIS INITIATIVE, TO
REALLY PRODUCE THESE DATA SETS
THAT COULD INFORNL NAIN OTHER
WAYS IN IF THE FUTURE WHEN
BIOMARKER WORK COULD BEING DONE
IN ANOTHER PART OF THE
INITIATIVE OR PART OF THE
ONGOING INITIATIVE FOR
BIOMARKERS OF PAIN.
>>I GET THAT AND I APPRECIATE
THE RESPONSE, I THINK IT WOULD
BE INTERESTING TO POTENTIALLY
LOOK AT PROVIDING SUPPLEMENTARY
FUNDING TO DO ANALYSIS OF THESE
LARGE DATA SETS.
IT MAY NOT BE VALIDATION OF A
BLOOD BIOMARKER, WHATEVER, BUT
WHAT WE'RE TRYING--WHAT I THINK
A LOT OF RECENT RESEARCH HAS
SHOWN IS THAT, THERE'S LIKELY
GOING TO BE COMPLEX
BIOPSYCHOSOCIAL IGF NATURES OF
PATIENTS THAT HAVE DIFFERENT
OCCUR TRING CONDITIONS THAT WE
MAY BE ABLE TO IDENTIFY AT LEAST
THROUGH SCOPING WORK THROUGH
LARGE DATA SETS THAT MAY INFORM
THAT TYPE OF VALIDATION AND
DISCOVERY WORK THAT YOU'RE
TALKING ABOUT IN FUTURE
APPLICATIONS.
>>THAT'S EXACTLY THE KIND OF
WORK WE'RE LOOKING FOR IN IT
INITIATIVE, APPRECIATE YOU HIGH
LIELTING --LIGHTING THAT.
THANK YOU ERIC?
>>I HAVE A SEPARATE COMMENT BUT
I WANT TO SUPPORT WHAT CHRIS
BROUGHT UP.
IT'S INCREDIBLY IMPORTANT IF YOU
WANT TO UNDERSTAND THESE
INDIVIDUAL DIFFERENCES TO TAKE A
BIOPSYCHOSOCIAL VIEW AND THAT'S
NOT THE SAME AS VALIDATING NEW
BIOMARKERS BUT IF THE PROPOSED
APPLICATIONS HAVE BIOMARKERS
AVAILABLE, OR SOME SORT OF
NEUROPHYSIOLOGICAL MECHANISTIC
DATA THAT CAN BE REALLY USEFUL
APPROXIMATE IN DISCRIMINATING
THESE PHENOTYPES BUT WHAT I WANT
TO ACTUALLY COMMENT ON WAS IN
TERMS OF 1 PARTICULAR CO
OCCURRING CONDITION, THAT MIGHT
BE INTERESTING TO STUDY HERE, TO
EMPHASIZE IS THE CO-MORBIDITY
BETWEEN PTSD AND CHRONIC PAIN
WHICH WE KNOW IS PREVALENCE
RATES ARE INCREDIBLE LOAMACYY
HIGH AND PEOPLE STILL DON'T
REALLY UNDERSTAND THE PATHWAYS
BY WHICH PSYCHOLOGICAL TRAUMA,
IT IMPACTS PHYSICAL PAIN AND
PERHAPS IS TRANSDUCED INTO
PHYSICAL PAIN AND THAT'S
CERTAINLY A BELIEF OUT THERE IN
THE CLINICAL LITERATURE BUT I
THINK MORE LIGHT CAN BE SHED ON
HOW THESE 2 CONDITIONS INTERSECT
WITH 1 ANOTHER.
>>EXCELLENT SUGGESTION, ERIC,
THANK YOU.
ED?
>>YEAH, WELL, I ECHO AS A
CLINICIAN, I REALLY SUPPORT THIS
INITIATIVE AND THE COMMENTS THAT
HAVE BEEN MADE ALREADY, WHAT I
WANTED TO SAY, YOU MAY ALREADY
BE ALL OVER THIS, BUT DIFFERENT
MEDICAL SPECIALTIES SEE THESE
DIFFERENT PAIN SYNDROMES, RIGHT?
SO INTERN ICHTS SEE CHRONIC
FATIGUE, UROLOGISTS SEE
INTERSTITIAL CYSTITISI
RHEUMATOLOGIST SIGN FIBROMYALGIA
AND A LOT OF THEM RESPOND
PARTIALLY TO [INDISCERNIBLE]
DEPRESS ANTS BUT THEY PRESENT AS
DISTINCT SYNDROMES
[INDISCERNIBLE] BUT 1 WONDERS IF
THERE'S UNDERLYING MECHANIST
INCREASE IN BODY CONDITIONS ARE
ARE THEY CONNECTED
MECHANISTICALLY SO I WONDER IF
YOU HAVE IN MIND TO FOCUS ON
THAT AT ALL AND CERTAIN LE
THAT'S A BIG PART OF WHAT
CLINICIANS, WHAT CLINICIANS ARE
SEEING, PHYSICIANS OF DIFFERENT
TYPES?
NTHANK YOU SO MUCH FOR BRINGING
THAT UP ED.
THAT'S 1 OF THE REASONS WHY
WE'RE LOOKING FOR INCLUDING ONLY
INDIVIDUALS WITH AT LEAST 2
CHRONIC PAIN CONDITIONS, RIGHT?
SO THE--THE--FOR ALL THE REASONS
THAT YOU JUST LAID OUT, THERE
ARE COMMON MECHANISMS THAT
CLINICIANS SEE TWE'RE LOOKING
FOR WHERE THEY'RE COMING
TOGETHER, THERE'S BEEN GREAT
RESEARCH DONE IN THE PAST EVERY
YEAR THAT THE LATE HAS DONE A
LOT OF WORK IN THIS AREA FOR
EXAMPLE, AND THEN THE DATA SETS
THAT YOU KNOW CHRIS BEESLY
MENTIONED, THEY'RE ASKING THE
QUESTION THAT YOU'RE ADDRESSING.
WHAT WE'RE REALLY TRYING TO DO
HERE IN ADDITION TO
THOSE--LOOKING AT THOSE LARGE
DATA SETS AND LOOKING AT
POPULATION SIMILARITIES BETWEEN
THOSE WITH CHRONIC MIGRAINE AND
INTERSTITIAL SUBICITIS IS TO ASK
IN THOSE INDIVIDUALS THAT HAVE
THOSE MIXED 1S, WHERE IS THE
COMPLEXITY THERE?
WHAT ASPECTS WITH THE INDIVIDUL
VARIANT OF PAIN WITH THEIR OWN
SOCIAL ENVIRONMENT, ET CETERA
AND MORE IMPORTANTLY THERE
COMORBID HEALTH CONDITION SYSTEM
LEADING TO RESISTANCE FOR
SUCCESSFUL PAIN MANAGEMENT IN
THAT INDIVIDUAL?
IT IS A SUBTLY BUT IT IS MOVING
THAT RESEARCH FORWARD THAT'S
BEEN DONE ON A POPULATION LEVEL.
>>THIS IS SOMEWHAT RHETORICAL,
BUT I OOH SIEWM IT'S ADDRESSING
THE QUESTION, IF YOU HAVE AN
INDIVIDUAL WITH A COMORBID
CONDITION LET'S SAY MIGRAINE AND
IBS, SO DIFFERENT, IF YOU TREAT
1 SUCCESSFULLY, WHAT'S THE
LIKELIHOOD OF THE OTHER 1
ACTUALLY RESPONDING.
>>YEP, SURE.
THAT COULD BE INCLUDED HERE.
AND THERE ARE THOSE THAT HAVE
ASKED THESE QUESTIONS BUT ALSO
THAT, YOU KNOW THIS RESEARCH IS
REALLY FRACTURED AT THIS POINT.
PUTTING IT TOGETHER LIKE THIS IS
REALLY AN INNOVATION, I THINK.
>>THE OTHER PROBLEM I'VE SEEN
AND I NOTICED A LONG TIME AGO
WHEN I LOOKEDDA THE MEMBERSHIP
FOR THE INTERNATIONAL
ASSOCIATION FOR THE STUDY OF
PAIN, IT'S ABOUT IT'S ABOUT 40%,
50% ANESTHESIOLOGISTS, 30-40%
PSYCHOLOGISTS, THE REST ARE
BASIC NEUROSCIENTISTS, PHYSICAL
THERAPISTS, BASICALLY YOU COULD
COUNT THE NUMBER OF
RHEUMATOLOGISTS ON YOUR HAND.
ONCOLOGISTS FORGET IT.
AND IT'S INTERESTING BECAUSE
EITHER THOSE DISCIPLINES DON'T
SEE PAIN AS A PROBLEM OR THEY
DON'T--OR THEY THINK THEY CAN
DEAL WITH IT.
AND I WONDER WHETHER THE
INDIVIDUAL WHO CHOSES TO GO TO
THE RHEUMATOLOGIST AS OPPOSE TO
A PAIN CLINIC GETS COMPLETELY
DIFFERENTLY DIAGNOSED.
>>GOOD QUESTION.
>>I'M HAVING TROUBLE WITH THE
NEW INSTALLATION OF ZOOM SO I
DON'T KNOW HOW TO RAISE MY HAND,
BUT WHEN IT'S MY TURN, I WILL
SPEAK.
>>I GOT YOU ON THE LIST, WALLY?
CHRIS, YOU'RE NEXT AND THEN
WALLY.
>>I WANT TO QUICKLY COMMENT
THAT 1 OF THE REALLY KEY NEEDED
AREAS OF RESEARCH IS LOOKING AT
THE TEMPORALITY OF THE CO
OCCURRENCE OF THESE CONDITIONS,
RIGHT?
BECAUSE USUALLY BY THE TIME THAT
WE'RE IDENTIFYING PEOPLE THAT
FALL INTO THIS CATEGORY THEY'VE
EITHER HAD PAIN FOR 5 YEARS, 10
YEARS, SO ON AND SO FORTH, WE
REALLY JUST DON'T KNOW A WHOLE
LOT ABOUT HOW THE PERSON
PROGRESSES THROUGH THIS COMORBID
PATTERN, ARE THERE CERTAIN
CONDITIONS THAT ARE MORE LIKELY
TO PROCEED OTHERS?
DEVELOPMENT AT THE SAME TIME, SO
ON AND SO FORTH AND AT THE SAME
TIME DOES THAT COMBINE WITH
THEIR GENETIC AND ENVIRONMENTAL
EXPOSURES, SO I DON'T KNOW IF
THIS CAN ADDRESS THAT BUT
HOPEFULLY THAT CAN BE INCLUDED
IN THE IF, OA AS PART OF THE
DATA THAT ECTOMYOSIN KLF-TWOD
CAN INFORM THIS TYPE OF RESEARCH
IN THE FUTURE, I MEAN OPRA DID
LOOK AT THAT A BIT, MAP A LITTLE
BIT BUT NOT MUCH, THERE'S REALLY
A NEED TO DO THAT BECAUSE WE
JUST DON'T KNOW WHETHER PEOPLE
REMIT, CAN WE INTERVENE EARLY
AND STOP THE PROGRESSION OF
THESE OTHER COMORBID EITHER PAIN
OR NONPAIN CONDITIONS?
AND IT'S JUST A REALLY NEEDED
AREA OF RESEARCH.
>>THAT'S AN EXCELLENT
SUGGESTION.
DEFINITELY GOING TO BRING THAT
BACK TO THE TEAM AND HOPEFULLY
GENERATING THE NOVEL GROUPS IN
IN DATA SET AND STRONG DATA
SHARING RIERMS WILL PROVIDE THAT
DATA FOR OTHER WHO IS WANT TO
ASK THAT QUESTION ACROSS THE
DIFFERENT STUDIES THAT WE HAVE.
YOU KNOW BUT THIS IDEA OF
LONG-TERM LONGITUDINAL STUDIES,
THAT MIGHT BE A BIT OF A STRETCH
FOR THIS PARTICULAR INITIATIVE,
BUT ASKING QUESTIONS ABOUT HOW
LONG THAT THEY'VE SUFFERED FROM
THE CONDITIONS, YOU KNOW
OBVIOUSLY CAN BE INCLUDED.
WALLY?
>>I THINK CHRIS PRETTY MUCH
COVERED WHAT I WAS GOING TO SAY,
IESM VERY --I'M VERY INTERESTED
IN THIS NEEDLESS TO SAY AND
REALLY STRUCK BY WHAT ED NUNES
SAID EARLIER .
THE SATTA SET TO WHAT YOU WANT
DONE MIGHT NEED TO BE COMBINED
DATA SETS FROM DIFFERENT
SPECIALISTS OR TEAMS OF DISEASE
SPECIALISTS WHO SEE CO
OCCURRENCES THAT WE DON'T EVEN
KNOW EXIST BECAUSE WE HAVEN'T
COMBINED THE DATA SETS BEFORE.
SO I WOULD VERY MUCH INVITE
RESEARCHERS FROM DIFFERENT PAIN
FIELDS, THANK YOU ALAN FOR THAT
EXCELLENT IASP MEMBERSHIP
ANALYSIS THAT YOU PROVIDED.
I WAS NOT AWARE OF THAT ALTHOUGH
I DID SUSPECT IT.
AND WHAT WE'RE LOOKING FOR IS
THE PATIENTS OF THE DOCS WHO ARE
NOT MEMBERS OF THE IASP.
AND WE'RE LOOKING FOR DOC WHO IS
DON'T TALK TO EACH OTHER,
RHEUMATOLOGISTS AND CANCER
SPECIALISTS, ENDOCRINOLOGISTS
AND GASTROENTHUSIASMERROLOGYISTS
AND I'M NOT LEAVING OUT
ANESTHESIOLOGISTS BUT I'M SAYING
THAT THOSE DATA SETS THAT YOU'RE
LOOKING TO DO THIS ANALYSIS ON,
ARE MAYBE DATA SETS THAT HAVE TO
BE CREATED.
MAYBE THEY'RE SITTING AROUND
INDEPENDENT OF EACH OTHER RIGHT
NOW AND THEY HAVE TO BE CREATED.
>>YEAH, SO, AGAIN, THIS WE HEAR
LOUD AND CLEAR EXPW WE AGREE
WITH YOU, THIS IS 1 OF THE
REASON YES WE'RE PUTTING THAT
REQUIREMENT ON MULTIPLE PAIN
CONDITIONS, BUT I THINK THAT ON
THIS CALL AND THE SUGGESTION
FROM THE MDWG IS REALLY SPELLING
IT OUT THAT IT'S COMING FROM
DIFFERENT SOURCES, SUCH AS THOSE
WITH DIFFERENT EXPERTISE,
RHEUMATOLOGISTS, NEUROLOGISTS,
THOSE WITH, YOU KNOW GI
EXPERTISE, ET CETERA, ET CETERA,
WE HEAR YOU LOUD AND CLEAR, IT'S
GREAT SUGGESTIONS.
KAREN?
>>THE OTHER THING YOU WANT TO
LOOK FOR IS FAMILY PHYSICIANS
BUT THEY SHOULD BE HERE TOO, BUT
THE GREAT OPPORTUNITY YOU HAVE
HERE IS TO LOOK AT THE
TRAJECTORY AND THE ORDER IN
WHICH PATIENTS SOUGHT CARE, WHO
DID THEY SEE FIRST, NEXT, WHO
DID THEY SEE NEXT?
BECAUSE THERE IS EMERGING DAT
THAT IF YOU CHANGE THE ORDER, WE
ACTUALLY DECREASE PAIN AND
INCREASE FUNCTION AND DECREASE
COSTS.
SO YOU HAVE BY COMBINING THESE
DATAET ISS HAVE YOU THE
OPPORTUNITY TO AS A SECONDARY
ANALYSIS, LOOK AT WHERE DO THEY
SEEK CARE AND WHAT HAPPENS IF
THE ORDER IS DIFFERENT.
>>GREAT.
THANK YOU.
ALL THESE SUGGESTIONS HAVE BEEN
REALLY EXCELLENT.
I THINK WE NEED TO GO ON TO THE
NEXT INITIATIVE UNLESS SOMEBODY
HAS A BURNING QUESTION.
>>I WANT TO MAKE 1 MORE POINT.
NOW, ALAN, I THINK YOU'RE
ABSOLUTELY WRONG, WE DON'T THINK
THAT WE GOT IT UNDER CONTROL.
IN FACT, IT'S THE OPPOSITE.
>>DID I SAY IT WASN'T UNDER
CONTROL.
>>WELL YOU SAID SOMETHING ABOUT
THEM--
>>OH I COMPLETELY AGREE WITH
YOU.
>>IT'S NOT THAT THEY THINK THEY
CAN DEAL WITH THE FRAIN OF THEIR
PAICIALTS, IT'S THAT THEY'RE SO
FRUSTRATED BY THE PAIN THAT THEY
JUST IGNORE IT RATHER THAN TRY
TO DEAL WITH IT OR WORSE, THEY
TREAT IT WITH LESS THAN IDEAL
TREATMENTS.
SO, I WANT TO GO ON RECORD AS
SAYING, WHEN WE PUT THIS RFP
OUT, THOSE ARE SOME OF THE
PEOPLE WE NEED TO BE APPEALING
TOO.
>>I ACTUALLY HAD A COROLLARY
THOUGHT TO THAT, I COMPLETELY
AGREE WITH YOU WALLY, BUT TAKE
THE ONCOLOGISTS WHO OBVIOUSLY
DEAL WITH PAIN ALL THE TIME, AND
OPIOIDS ARE VERY COMMONLY USED
AND IN SOME CASES APPROPRIATE IN
A PATIENT, CERTAINLY A PATIENT
WHO'S TERMINAL.
BUT I HAD THIS CRAZY THOUGHT IN
THE CONDITION OF WHICH I THINK
IS SOMEWHAT INTERESTING BUT
CONTROVERSIAL OPIOID INDUCED
HYPER ALGEESIA, SO HERE'S A
POPULATION OF PATIENTS THAT
RECEIVED LOTS OF NARCOTICS, THEY
MAY HAVE UNDERLYING RPGHT PAIN
CONDITIONS, WHEN THERE IS HYPER
ALGEESIA, DOES IT MANIFEST INTO
DIFFERENT CO-MORBIDITIES?
OR DOES IT MANIFEST IN THE
CONDITION THAT WAS--WHAT THE
ONCOLOGIST THINKS HE OR SHE IS
TREATING.
>>YEAH, EXCELLENT QUESTION.
I DON'T KNOW THE ANSWER.
>>THANKS, EVERYBODY FOR YOUR
INPUT.
WE REALLY DO NEED TO GO ON
BECAUSE THERE'S A WHOLE BUNCH
MORE INITIATIVES TO PRESENT.
I MEAN THIS IS--
>>[SPEAKING AT ONCE ]
>>IF YOU GET THE WHYED THAT
WE'RE INTERESTED IN THIS.
>>YES!
YES?
THIS IS GREAT!
>>OKAY.
>>WE HAVE A RHEUMATOLOGIST HERE
AMONG US, DR. LINDSAY CRISWELL,
WHO IS THE DIRECTOR OF THE
NATIONAL ENITUTE OF--OOH,
ARTHRITIS AND MUSK LO SKELETAL,
AND SHE HAS ENTERED COMMENTS IN
THE CHAT VERY MUCH IN LINE WITH
WHAT WALLY AND ALAN WERE JUST
DISCUSSING BUT WILL BRENG YOUR
ATTENTION TO THAT, AND THANK YOU
LINDSAY BUT PLEASE GO AHEAD.
>>NEXT SLIDE, PLEASE.
--SOME DATA HERE ARE NOT STRONG
MECHANISTIC CATASO THE GOAL OF
THE INIAATIVATIVE IS TO SUPPORT
MECHANIST BEING RESEARCH TO
TODAY HOW THE EXPOSOME INTERACT
WITH KNOWN AND NEW TARGETS THAT
COULD AFFECT PAIN, ITS OUTCOME
AND ITS EXPRESSION.
THE EXPOSOME FACTORS COULD
INCLUDE THE MICROBIOME, DRUGS
AND ALCOHOL, SLEEP, STRESS ASK
REALLY DOING THE MECHANISTIC
STUDIES AS WELL AS PSYCHOSOCIAL
MEDS.
PREVENTIVEIOUSLY DISCUSSED ON
THIS CALL.
WE WANT TO STUDY HOW THESE
EFFECTS ARE KNOWN AND OW THE
PAIN AFFECTS OUTCOME AND THESE
PRECLINICAL STUDIES ARE THE
FOCUS BUT MECHANISTIC CLINICAL
TRIALS WILL NOT BE EXCLUDED AND
WHERE APPROPRIATE THEY COULD BE
INCLUDED IN THE APPLICATION.
AND THEN THE GOAL OF THE
APPLICATION FROM OUR PERSPECTIVE
WHICH WILL BE TO SHOW CLEAR
ASSOCIATION WITH A CHOSEN
EXPOSOME FACTOR WITH A PAIN
CONDITION IN HUMANS AND THEN
KIND OF BACK TRANSLATE INTO THAT
MECHANISTIC STUDY.
NEXT SLIDE.
SO HOW DOES THIS FIT INTO THE
HEAL PROGRAMS, I THINK WE
MENTIONED IT SIMILAR TO THE
OTHER 1S AND WE DON'T BE HAVE TO
GO THROUGH ALL OF THEM, BUT THE
GOAL HERE IS TO ROUGH ATOM VIED
THE MECHANIST BEING SUPPORT, FOR
A CLINICAL PERCEPTION THAT THE
CLINICIANS HAVE OR HAVE BEEN
SHOWN IN THE LITERATURE TO AN
EXISTING EXPOSOME FACTOR THAT'S
BEEN KNOWN TO INFLUENCE PAIN.
THAT'S THE GENERAL OVERALL GOAL
OVER HERE AND THIS IS A BUNCH OF
DETAILS ASSOCIATED WITH IT.
NEXT SLIDE.
LET'S SETTLE IN HERE ON THE
QUESTIONS, DOES THE EXISTING
LITERATURE WITH HUMANS PROVIDE
ROBUST EVIDENCE FOR SOME
EXPOSOME FACTORS THAT CAN BE
INCLUDED HERE, ALL RIGHT, AND
YOU KNOW IS THERE THAT
SCIENTIFIC EVIDENCE TO SAY THAT
WE'RE READY TO LOOK AT SOME OF
THESE MECHANISMS?
WHAT EXPOSOME FACTORS SHOULD BE
PRIORITIZED IF ANY?
SHOULD BE OPEN.
ARE THERE PARTICULAR
STAKEHOLDERS THAT WE SHOULD
ENGAGE TO INSURE THE SUCCESS OF
THESE STUDIES OR THE--FIGURE OUT
WHICH EMPHASIS OF THIS
PARTICULAR INITIATIVE SHOULD BE
AND I WILL STOP THERE AND OPEN
IT FOR QUESTIONS.
>>I THINK THE FIRST BULLET
POINT IS AN IMPORTANT QUESTION I
KNOW YOU'RE PART OF THAT PAPER,
TOO, IT HAS DISCUSSION ABOUT
THIS BUT SEE THANKSGIVING WAS
THE FIRST TIME I HEARD THE TERM
EXPOSESOME AND WOULD BE
INTERESTED TO HEAR MORE ABOUT
THAT.
>>YEAH, I WANT TO TALK ABOUT
THE TERM EXPOSOME, WHAT I HAVE
ASSOCIATED WITH THE EXPOSOME, IS
THE NOTION THAT YOU'RE CAPTURING
THE COMPREHENSIVE TOTALITY OF
EXPOSURES THAT MIGHT BE RELEVANT
AND HERE IT SEEMS LIKE THERE'S
PARTICULAR EXPOSURES THAT ARE
MEASURABLE FOR WHICH WE HAVE
SOME INFORMATION ABOUT SO I
WONDER WHETHER JUST TALKING
ABOUT THE EXPOSURES AS OPPOSE TO
THE EXPOSOME, SO THERE MIGHT BE
CONFUSION GENERATED BY USING THE
TERM EXPOETICSOME, JUST A
THOUGHT TO SHARE AS SOMEONE WHO
HAS BEEN THINKING ABOUT EXPO
STUDIES OF MULTIPLE ENDOCRINIC
RESEARCH IN THAT CONTEXT.
>>GOOD POINT LINDE.
DAVE IS ON, DO YOU WANT TO
ADDRESS THAT QUESTION ABOUT THE
USE OF THE EXPOSOME TONE OVER
HERE AND FOCUSING ON PARTICULAR
FACTORS OR ONLY FACTORS THAT ARE
REALLY MEASURABLE OR
QUANTIFIABLE.
NYEAH, CAN YOU HEAR ME.
>>YEAH, WE CAN HEAR YOU GO FOR
IT.
>>JEA, SO SO THIS IS PROBABLY
GOES BACK TO--I WON'T GO THROUGH
A LONG SPEECH BUT IT GOES BACK
TO PROBABLY 2005 AND A LOT OF
THE ICs AND AT INSTITUTES AND
CENTERS HERE AT NIH ARE WORKING
ON THIS CONCEPT AND IN FACT WE
HAVE A NEW OFFICE HERE CALLED
THE NEURAL EXPOSOME AND
NEUROTOXICOLOGY WHICH I LEAD,
AND I THINK IT DID REALLY JUST
BY ITS DEFINITION INCLUDE JUST
ABOUT EVERYTHING THAT'S NOT
INHERITABLE AND IT DOES INCLUDE
LOOKINGA THE THESE TOGETHER AND
NOT JUST IN THE AN ISOLATED
PART, THAT'S NOT WHAT THE
CONCEPT IS ABOUT.
SO LET'S SEE--SORRY, I WAS
TALKING TO SOMEONE ELSE BUT WHAT
WAS THE OTHER QUESTION?
>>NO, THAT'S OKAY, YOU
ADDRESSED THAT QUESTION VERY
WELL.
>>SO IS THERE A DIFFERENCE
BETWEEN BIOPSYCHOSOCIAL AND
ENVIRONMENTAL FACTORS AND
EXPOSOMIC FACTORS ARE ARE WE
USING DIFFERENT WORDS TO TALK
ABOUT THE SAME THING.
>>GO AHEAD, GAVE.
NO, NO, NO, IT ABSOLUTELY IS
INCLUDED AT LEAST IN OUR CONCEPT
OF THE NEUROEXPOETICSOME.
SO, YEAH, IT'S MAYBE YOU'RE
RIGHT IN SOME WAY IT IS SORT OF
THE SAME THING BUT IT'S
DEFINITELY INCLUDED.
>>EXCEPT NOT THE GENETIC
FACTORS WHICH IS A BIOFACTOR,
RIGHT, SO THAT'S THE ONLY PART--
>>OKAY, SO THAT RAISES THE
QUESTION FOR ME, NEW TERM FOR ME
AS WELL, EXPOSOME.
ARE YOU LOOKING FOR EPIGENETIC
STUDIES HERE?
>>ABSOLUTELY.
>>OKAY.
>>THAT'S PART OF IT.
>>FOR YOUR POINT, MICHAEL, BY
COMBINING DRUGS AND WHOLE, MY
INITIAL REACTION WITH THAT THOSE
ARE ILLICIT DRUGS BUT THE FACT
IS I WOULD THINK PART OF THE
EXPOETIC STUDIES OF MULTIPLE
ENDOCRINE ARE ACTUALLY
ANALGESICS THAT ARE USED IN THE
INDIVIDUALS.
>>I LIKE IT.
SOUNDS GOOD.
>>ABSOLUTELY.
>>CHRIS?
>>SO SOME OF THE DATA I'VE
SEEN, THERE ARE CERTAINLY BY O
PSYCHOSOCIAL FACTORS THAT ARE
OOH DENTIFIED AS BEING MORE
COMMON IN PEOPLE WITH CHRONIC
PAIN BUT WHAT RECENTLY I'VE SEEN
STUDIES FOCUS ON AND SOME OF THE
DATA SUGGEST IS THAT IT'S NOT
NECESSARILY THE FACTORS ALONE,
IT'S THE BIOPSYCHOSOCIAL FACTORS
IN COMBINATION.
SO IF YOU'RE NOT ALLOWED AM I
CORRECT IN UNDERSTANDING THESE
STTDS WILL NOT AT ALL FOCUS ON
BIOFACTORS?
AND IF SO, AREN'T WE KIND OF
MISSING SOMETHING BY NOT LOOKING
AT THE INTERPLAY OR
BI-DIRECTIONAL ASSOCIATION
BETWEEN BIOLOGIC AND EXPOSOMIC
FACTORS?
>>I CAN TAKE THAT, WELL,
ACTUALLY, THAT'S THE WHOLE--WELL
1 OF THE MAJOR PARTS OF THIS IS
TO TRY TO SEE HOW THESE FACTORS
INTERACT WITH SOME OF THE
TARGETS SO SOME OF THE
BIOLOGICAL TARGETS.
>>BIOLOGICS INCLUDED YOU'RE
JUST NOT SPECIFICALLY GENETIC
FACTORS, INNER HITTABLE FACTORS.
>>THAT MAKES SENSE.
THANKS.
>>PRESUMABLY FAMILY IS
INCLUDED?
>>THEY'RE SOCIAL INTERACTIONS.
>>OKAY.
>>JUST IT'S SO BROAD.
>>YES.
>>IT IS BROAD AND THE DATA
SETS, PARTICULARLY IF YOU'RE
LOOKING FOR STUDIES OF
EPIGENETICS, THE DATA SETS HAVE
TO BE OUT --I WOULD EXPECT HAVE
TO BE HUGE SO THE GOAL IS TO GET
ENVISIONING STUDIES SO THE
APPLICANT WILL PICK 1 OR A FEW
FACTORS AND THEN ASK THE
MECHANISTIC QUESTIONS.
SO THE GOAL HERE ISN'T TO
DETERMINE WHAT EVERY FACTOR IS,
BUT REALLY ASK QUESTIONS ON
PARTICULAR FACTORS THAT THERE
ARE EXISTING DATA SETS OR HINTS
IN THE LITERATURE THAT THOSE
FACTORS THAT DO HAVE AN EFFECT
ON PAIN.
>>YEAH, RIGHT.
AND THIS IS ALL RELATED TO
BETTER AND MORE BIOLOGICAL
PLAUSIBILITY IF YOU WILL FOR THE
CLINICAL RELEVANCE OF SOME OF
THESE FACTORS THAT LOOK LIKE
THEY ARE ASSOCIATE WITH PAIN.
>>YEAH, ALL IN FAVOR OF THAT 1,
I THINK THAT 1 IS CLEAR TO ME
BUT I'M NOT A GOOD ENOUGH
SCIENTIST TO TELL YOU WHERE I
WOULD GO TO FIND A DATABASE WITH
THAT KIND OF CLINICAL RICHNESS
BUT ALSO THE ABILITY TO DO THE
EPIGENETICS.
I KEEP HARPING ON THAT 1 BECAUSE
THAT 1 FOR ME-- YOU HAVE TO BE
PURPOSEFUL IN COLLECTING THE
DAILY BASIS THEA IN ORDER TO DO
THE EPIGENETIC STUDIES.
>>IS A MISTAKE TO TRY TO
PRIORITIZE THE PARTICULAR
EXPOETIC STUDIES OF MULTIPLE
ENDOCRINIC FACTORS IF THAT IS A
WORD THAT WE MIGHT WANT TO
STUDY, RATHER THAN LEAVING IT SO
COMPLETELY OPEN ENDED AND
SOMEBODY SAYS I'LL DO THIS AND
SOMEONE ELSE SAYS I'LL DO THIS 1
AND I'LL DO THIS 1 AND THEN YOU
WILL END UP WITH RANDOM
OBSERVATIONS BUT IF WE
PRIORITIZE PERHAPS WE'LL GET A
FEW MORE GROUPS FOCUSING ON THE
SAME QUESTION AND THEN WE MIGHT
ACTUALLY HAVE MORE MEANINGFUL
RESULTS SO 1 WAY TO PRIORITIZE
IS TO SAY THERE HAS TO BE A
STRONG RATIONAL FROM EXISTING
DATA SETS THAT THIS PARTICULAR
EXPOSOMIC FACTOR IS RIGHT TO BE
STUDIED IN A MECHANISTIC TODAY.
IN ORDER FOR THE APPLICANT DO IT
AS OPPOSE TO HAVING A SMALL
NUMBER OF PEOPLE CHOOSING WHICH
FACTORS COULD BE DONE WHICH
COULD HAVE A BIAS.
, FAIR ENOUGH.
>>A FEW WAYS TO DO IT AND TO
ADD TO THAT THERE'S A LOT OF
PEOPLE WORKING IN THIS SPACE.
IT'S KIND OF WEIRD NAMING
EVERYTHING BUT WE'RE HOPING TO
HAVE SOME GOOD REVIEWERS THAT
WILL BE ABLE TO--BECAUSE THAT'S
A GREAT QUESTION.
I WAS WORRIED ABOUT THAT.
>>ERIC?
>>JUST TO ECHO CHRIS' EARLIER
COMMENT THOUGH, DON'T WE WANT TO
LOOK AT THIS SORE SHOULDN'T THIS
BE LOOKED AT IN EMERGING ITS OF
A MULTIVARIANT PROCESS BECAUSE
PEOPLE AREN'T GETTING EXPOSED TO
1 FACTOR.
THEY'RE GETTING ECPOSED TO A
SYSTEM.
>>THAT WOULD BE RESPONSIVE TO
THIS IF THEY CAME IN WITH
MULTIPLE FACTORS.
>>OKAY.
>>AND THEN MAYBE I DON'T KNOW
SOME SORT OF MACHINE LEARNING
FOR EXAMPLE.
>>YEAH, YEAH.
>>MACHINE LEARNING TO COMBINE
OR LOOK FOR CLUSTERS OF
EXPOSURES OR PATTERNS AND THAT
BECOMES THE BASIS FOR TRYING TO
FIND THE MECHANISM.
I THINK I'M STARTING TO GET
THIS, THANK YOU.
>>IF YOU WANT TO LEARN MORE,
THERE'S ALL SORTS OF THINGS
THERE'S BOOT CAMPSA THE
COLUMBIA, ALL SORTS OF PEOPLE
WORKING IN THIS SPACE AND EVEN
THINGS HERE AT NIH THAT YOU
COULD LOOK AT THOSE FACTORS AND
IF AND HOW THEY ARE RELATED.
I AM HAPPY TO GIVE MORE
INFORMATION.
WE HAVE A WEBSITE, TOO, IF YOU
WANT TO LOOK.
>>YEAH, THERE'S A WEBSITE IN
THE CHAT, THERE THAT YOU CAN
TAKE A LACK AT FOR DAVE'S OFFICE
AT NINDS, FOR THE EXPOSURES ON
THE EXPOSOME.
ANY OTHER QUESTIONS OR
SUGGESTIONS?
OKAY, THANKS TO THE MDWG FOR
YOUR TREMENDOUS ENGAGEMENT WITH
THESE TBO INITIATIVES AND YOUR
ADSLICE, ALL OF THEM ARE GREAT
SUGGESTIONS.
>>MICHAEL AND WALTER, I THINK
WE'RE KIND OF NOW IN GENERAL
DISCUSSION IS THAT CORRECT?
>>MM-HMAMERICA.
>>THANK YOU.
I WOULD ASK THE GROUP JUST FOR A
GENERAL LEVEL OF ENTHUSIASM FOR
THESE NEW CONCEPTS AND ALSO
TAKING INTO CONSIDERATION WHAT
YOU SAW EARLIER IN TERMS OF THE
MANY MORE FOCUSED THERAPEUTIC
DEVELOPMENT OR TARGETED
APPROACHES HOW THIS MORE
INVESTIGATIONAL APPROACH THAT
MICHAEL JUST--OR THE APPROACHES
WE JUST DISCUSSED FIT IN AND I
WOULD INVITE WALTER AND LINDSAY
AND ELEN AND ALL OF THE MEMBERS
OF THE EXECUTIVE COMMITTEE TO
WEIGH IN WITH THEIR QUESTIONS OR
AREAS WHERE THEY WOULD LIKE
ADDITIONAL FEEDBACK FROM THE
MULTIDISCIPLINARY WORKING GROUP
ABOUT THIS AREA OF RESEARCH
FOCUS FOR HEAL.
I WOULD JUST PUT IN THE CHAT
THAT YOU KNOW I THINK EVERYBODY
REALIZES, THESE ARE IMPORTANT
AND THAT'S KREBS CYCLE WE'RE
DOING THEM.
IN MY MIND, THESE ARE REALLY
HARD PROBLEMS TO GET SOMETHING
SIGNIFICANT OUT OF, SO I THINK
OUR CHALLENGE WILL BE TO GO FROM
ASSOCIATIONS TO CAUSALITY, AND
THAT'S NOT GOING TO BE EASY AND
THERE, YOU KNOW YOU MAY HAVE TO
BREAK IT DOWN AND GO AFTER 1
THING AT A TIME, MAYBE 2 THINGS
AT A TIME AT MOST, I THINK WE
WILL SEE A LOT OF ASSOCIATIONS,
THERE WILL BE HYPOTHESIS
GENERATING, BUT THEN TO REALLY
MAKE PROGRESS, I THINK WE'RE
GOING TO HAVE TO LOOK AT HOW AN
INTERVENTION ACTUALLY AFFECTS,
SO WE HAVE MULTIPLE
CO-MORBIDITIES, YOU WOULD LIKE
TO MAKE THE WHOLE PERSON FINE
BUT THAT'S NOT GOING TO HAPPEN.
SO, YOU KNOW THEY HAVE SEVERE
OFTIO ARTHRITIS, YOU CAN'T MAKE
IT GO AWAY, THEY HAVE
DEPRESSION, THEY HAVE PAIN, SO
THEN ATTACKING THE DEPRESSION
FOR THE EFFECTS OF PAIN, MAYBE
COMBINATIONS, I THINK WE WILL
HAVE--THE ANSWER WILL BE IN HOW
THESE DIFFERENT GROUPS RESPOND
TO THE INTERVENTIONS.
WITH RESPECT TO EXPOSOME, AGAIN,
IT'S HARD BECAUSE IT'S
EVERYTHING THAT'S NOT GENETIC
BUT YOU KNOW IN PAIN, I THINK
YOU COULD MAKE STRONG CASES FOR
THINGS LIKE CHILDHOOD INJURY OR
YOU KNOW CHILDHOOD EXPOSURE, THE
PAIN MEDS OR SOMETHING LIKE THAT
AND HAVE THAT INFLUENCES
SOMEONE'S RESPONSE TO PAIN PAIN
IN THE FUTURE, CERTAINLY ALL OF
THESE RELATED TO INJURY, HEAVILY
RELITTED TO OCCUPATIONAL OR
SPORTS ACTIVITIES THAT PEOPLE
ARE EXPOSED TO THAT THEN GET
THEM INTO TROUBLE.
I DON'T THINK WE HAVE A HANDLE
ON YOU KNOW WHAT THAT IN TOTAL
LOOKS LIKE, THE INTEGRAL OVER
TIME SO I THINK THERE'S LOTS OF
AREAS TO GO INTO HERE, BUT
IT'S--IT'S ALMOST LIKE GOING TO
ANOTHER PLANET AND SETTING UP A
SPACE STATION IN A SENSE AND
THEN TRY TO BUILD OUT SO THAT'S
WHAT HE CAN DO, YOU KNOW NO
INSTITUTE CAN DO THOSE KIND OF
THINGS.
>>LINDE, DO YOU HAVE THOUGHTS?
>>YEAH, BOTH OF THESE ARE
REALLY IMPORTANT AREAS WHERE
MUCH RESEARCH IS NEEDED I JUST
WOULD REITERATE WHAT I THINK I
HEARDAL AN SEE I THINK IN TERMS
OF EXPOETICSOMICS PROJECT, IF
SOME STRUCTURE OR PRIORITIZATION
IS NOT OFFERED UP FRONT, YOU
COULD GET EVERYTHING FROM AN
EXPOETICSOMIC STUDY WHERE SERUM
IS ANALYZED WITH YOU KNOW STATE
OF THE MASCULINIZED SPEC LIQUID
CHROMEATOGRAPHY TECHNOLOGIES TO
IDENTIFY DIFFERENCES IN CHEMICAL
EXPOSURES BETWEEN GROUPS TO
FOCUS STUDIES THAT LOOK AT
SPECIFIC FACTORS THAT ARE
ALREADY IMPLICATED IN PAIN
MECHANISMS BUT I THINK THAT IF
IT'S LEFT OPEN, YOU SHOULD BE
PREPARED TO ACCEPT ANYTHING
ACROSS THAT BROAD SPECTRUM SO
YOU KNOW I WONDER WHETHER IT'S
WORTH ADDITIONAL DISCUSSION
AMONG MDWJ AND STAFF TO THINK
ABOUT WHETHER THEY WANT TO
IDENTIFY HIGH PRORRITY AREAS AS
A STARTING POINT TO BUILD UPON
VERSUS ALLOW ALL COMERS SO I
THINK THE FIRST PROJECT IS MORE
MANAGEABLE IN THAT RESPECT BUT
BUT I'M REACTING AGAIN TO THE
TERM EXPOETICSOMICS AND THE VAST
RANGE OF POTENTIAL PROPOSALS YOU
MIGHT SEE IF IT'S FRAMED IN THAT
WAY.
>>THANKS, LINDE AND THEN,
CHRIS, YOU'RE NEXT AND THEN I
HAVE NORA.
>>YEAH, I JUST WANT TO
PIGGYBACK OFF THAT AND WHAT ALAN
SAID.
I'M OBVIOUSLY VERY SUPPORTIVE OF
BOTH OF THESE CONCEPTS I JUST
WONDER IF THERE'S A POSSIBILITY
AND I KNOW IT TAKES MORE ACCORD
NATION ON YOUR SIDE BUT WHETHER
THIS COULD BE CONSIDERED LIKE A
COLLABORATIVE RESEARCH PROJECT
SO THAT YOU DON'T HAVE, YOU KNOW
JUST DESPERATE STUDIES THAT ARE
WORKING IN ISOLATION BUT MAYBE
THERE'S MORE OF A COLLABORATIVE
APPROACH ON IDENTIFYING WHAT THE
HIGH PRIORITY FACTORS MAY BE TO
INVESTIGATE AND THEN DOING THAT
ACROSS OBVIOUSLY YOU HAVE TO SEE
WHO'S INTERESTED AND WHAT
SPECIFIC GROIPS MIGHT HAVE THE
CAPABILITIES TO RESEARCH WHICH
BUT I'M ALWAYS IN FAVOR OF KIND
OF MORE OF THE TEAM BASED
COLLABORATIVE APPROACH BECAUSE I
FEEL LIKE YOU MAX MID WHAT WE
LEARN IN A SHORTER PERIOD OF
TIME RATHER THAN FUNDING 2 OR 5
DESPERATE STUDIES WHICH LIKAL AN
SAID, 1 LOOKING AT THIS AND THE
OTHER LOOKINGA THE THAT.
>>THAIRNG YOU.
AND THEN NORA.
>>I TOTAL AGREE THAT THESE
STORIES ARE NOT JUST
COLLABORATIVE BUT IN ISOLATION,
WE HAVE PROJECTS TO MAXIMIZE
THAT FROM HAPPENING, I ALSO
AGREE WITH WALTER AND I THINK
THAT THE NOTION IS IN TERMS OF
THIS IS VERY VOLUNTEERSUBLE, IT
CAN HELP US IDENTIFY POTENTIAL
BIOMARKERS, EVEN IF OUR AIM IS
NOT FACT Y'ALLLY TO LOOK AT THAT
AND THAT WILL BE A CHALLENGE,
IT'S ABSOLUTELY RIGHT.
BUT WHEN I THINK ABOUT IT, IT
BEHOOVES US TO UNDERSTAND AS IT
HAS BEEN SAID BY OTHERS IS THE
NOTION THAT WE HAVE TO MAKE
DECISIONS IN TERMS OF WHAT OUR
PRIORITY PROJECTS AND AND THAT'S
WHERE HAVING TO REPORT BECOMES
IMPORTANT AND ALSO RECOGNIZING
THAT IS AN INITIATIVE WHICH I AM
VERY SUPPORTIVE, IT'S VALUABLE,
BUT THERE ARE ALSO OTHER WAYS
PERHAPS THAT WE CAN GET THAT
SIMILAR TYPE OF INFORMATION BY
TAKING ADVANTAGE ALREADY OF
ONGOING PROJECTS THAT ARE
HAPPENING, AND OBVIOUSLY 1 OF
THE 1S THAT IS THE LOW HANGING
FRUIT IS THE ALL OF US PROJECT
WHERE THERE HAVE BEEN ENORMOUS
AMOUNTS OF RESOURCES IN TOARDER
TO BUILD AN INFRANCIS COLLINS
STRAWCTURE TO FOLLOW UP
INDIVIDUALS AND THAT WILL
INCLUDE OBTAINING THE
BIOMARKERS, AND SO THAT'S WHAT I
WANTED TO PUT FORWARD.
I MEAN, WE RELY ON YOU TO GET
THE PERSPECTIVES BUT I WANT YOU
TO BE AWARE ABOUT THE OTHER
PLAYERS THAT MAY BE BEHIND THE
SCENES THAT WHERE 1 MAY BE ALSO
TO ADVANCE THIS AREA OF SCIENCE.
SO WE, ALL OF THE INSTITUTES ARE
PUTTING RESOURCES THAT MAY BE
VERY RELEVANT TOWARDS THESE AND
PERHAPS IF WE CAN USE THAT HEAL
COMPONENT TO BRING THEM IN A
COLLABORATIVE FASHION, WE CAN
MACK MYSELF THE ABILITY OF
EXTRACT RELEVANT INFORMATION FOR
BIOMARKERS FOR PAIN.
>>THANK YOU NORA.
MAYBE WHEN WE GET TO THE END
AFTER WE HAVE THE CLINICAL TEAMS
PRESENT TO THINK ABOUT OF THAT
TOGETHER.
WE HAD A LOLT OF CONVERSATIONS
WITH THE ALL OF US RESEARCH
PROGRAM AT NIH WHICH IS VERY
LARGE LONGITUDINAL COHORT TODAY
WITH AMERICANS DONATING THEIR
HEALTH RECORDS TO THIS NEW
RESEARCH PROGRAM.
MY UNDERSTAND SUGGEST RIGHT NOW
THEY DO NOT COLLECT THAT MUCH
INFORMATION ABOUT PAIN, HOWEVER,
THEY HAVE AN ANNUAL SURVEY THAT
THEY'RE HOPING TO ADD PAIN
QUESTIONS TO AND UNFORTUNATELY,
OUR CLINICAL PHYSICIAN PAIN
MANAGEMENT TEAM HAS DONE A
TREMENDOUS JOB IDENTIFYING AND
PUBLISHING COMMON DATA ELEMENTS
FOR THE MEASUREMENT OF PAIN AND
SOME ASSOCIATED MEASURES IN
CLINICAL POPULATIONS SO THAT'S
JUST READY FOR THEM TO USE AND
TO BE KIND OF INCORPORATED INTO
A FUTURE SET OF RESEARCH
QUESTIONS, SO WE CAN TALK ABOUT
THAT A LITTLE BIT MORE AND LINDA
AND JANE ARE WITH THAT GROUP AND
WE CAN ASK THEM TO SPEAK IT TO
IT TOO BUT IT'S A REALLY
IMPORTANT DIRECTION FOR HEAL.
AND IT'S GOOD TO THINK ABOUT
THEM AS THE SAME TIME AS
THESE--THE DISCUSSION WE JUST
HAD.
SO, HELENE, I WILL GIVE YOU THE
LAST QUESTION AND THEN WE WILL
GO FOR A QUICK BREAK.
>>WELL I WANTED TO ADD 1 QUICK
THOUGHT TO THIS EXPOSESOME
INTERESTING CONVERSATION,
PERHAPS 1 WAY TO FOCUS THIS A
LITTLE BIT MIGHT BE TO THINK
ABOUT SPECIAL POPULATIONS OF
PATIENTS WHO HAVE SEVERE AND
PERHAPS COMPLEX COMBINATIONS OF
ENVIRONMENTAL EXPOSURES.
FOR EXAMPLE, I WAS THINKING
PERHAPS LIKE FIREFIGHTERS OR
PEOPLE WHO ARE EXPOSED TO A
COMBINATION OF HIGH PSYCHOLOGY
STRESS BUT ALSO THAT HAVE
ENVIRONMENTAL EXPOSE--PHYSICAL
EXPOSURES, THAT MIGHT BE A VERY
INTERESTING QUESTION AS TO THE
IMPACT THAT THESE COMBINATIONS
OF EXPOSURES CAN HAVE ON
SOMETHING LIKE PAIN.
YOU KNOW, AND FIGURE OUT WHAT
ARE THE MODULATING FACTORS IS
HOW THESE CAN BE ADDRESSED MAYBE
THAT'S 1 WAY TO THINK ABOUT THAT
EXPOSOME TO NARROW IT A LITTLE
BIT.
>>GREAT.
THANK YOU FOR THAT SUGGESTION.
SO, WE HAVE A SCHEDULED BREAK
NOW UNTIL 12:35.
OH THAT'S EASTERN TIME.
SORRY FOR THOSE OF YOU SO IT'S
ABOUT 7-8 MINUTES, QUICK
BIOBREAK, STRETCH, BREAK, WALK
AROUND, GET READY FOR THE NEXT
SET OF REALLY GREAT
PRESENTATIONS FROM OUR CLINICAL
RESEARCH AND PAIN MANAGEMENT
TEAM.
THANK YOU EVERYONE SO FOR FOR
YOUR THOUGHTFUL CONTRIBUTIONS.
>>IT'S EXPOSOMIC BREAK.
>>NO, IS IT?
>>BE CAREFUL OUT THERE.
[LAUGHTER]
THANKS EVERYONE.
>>I WILL CALL US
BACK FROM A SHORT BREAK AND I
WILL INTRODUCE THE CO CHAIRS OF
THE CLINICAL RESEARCH AND PAIN
MANAGEMENT TEAM DR. LINDA PORTER
AND JANE ATKINSON.
THEY HAVE A TERRIFIC SET OF
CONCEPTS TO TALK ABOUT FOOD SO
AND WE ANTICIPATE A LOT OF
DISCUSSION SO I DON'T WANT TO
DELAY US ANY FURTHER.
LINDA PLEASE TAKE IT AWAY.
>>I WILL INDEED.
THANK YOU VERY MUCH.
SO JANE AND I ARE GOING TO TAG
TEEM A LITTLE BIT THIS MORNING,
I WILL START OUT WITH A VERY
QUICK OVERVIEW OF WHAT THE HEAL
CLINICAL PAIN MANAGEMENT
RESEARCH PORTFOLIO LOOKS LIKE,
VERY HIGH LEVEL SO IF YOU GO TO
THE NEXT SLIDE ISSUE PLEASE AS A
REMINDER SOME OF THESE PROGRAMS
GO BACK TO 2019 OF THE VERY
EARLY START OF HEAL, AND THEN
OVER TIME, A LOT OF NEW
PROGRAMS, A LOT OF EXCITING
PROGRAMS HAVE BEEN ADDED AND
THEN WE HAVE A LARGE SET OF
CONCEPTS THAT WE WANT TO PRESENT
TODAY, FOR FUTURE SUPPORT, FROM
HEAL, SO AT THE FAR LEFT, WE
HAVE THE EPIC NET WHICH IS OUR
FACE 2 TRIALS, 2 BEING ON NOW, 1
IN OFTIO ARTHRITIS AND 1 IN
DIABETIC NERVE PAIN.
THE BACK PAIN CONSORTIUM IS A
LARGE PROGRAM THAT HAS MULTILE
DIFFERENT TYPES OF APPROACHES TO
DIAGNOSING, TREATING DEVELOPING
THERAPIES FOR THOSE, FOR THE
TRIAL GOING ON NOW THAT JUST
LAUNCHED USING SOME OF THE
RESOURCES IN THE CONSORTIUM
THERE, IT'S LOOKING AT A COHORT
OF PATIENTS TO LOOK AT THEIR
DEEPLY PHENOTYPE THEM AND LOOK
AT WHAT INTERVENTIONS LOOK BEST
AND HELPING TO DEVELOP TAILOR'S
PERSONALIZED TREATMENTS.
WE'VE GOT THE PRAGMATIC STUDIES
THAT'S PRISM, THAT'S FINE
STUDIES THERE, THE PAIN
MANAGEMENT EFFECTIVENESS
RESEARCH NETWORK, THERE ARE 8
STUDIES GOING ON THERE, 1
ACTUALLY HAS FINISHED AND IS
ABOUT READY TO PUBLISH DATA ON
THE FINDINGS THIS, IS THE 1 ON
CAESAREAN PAIN AND OPIOIDS AND
ALTERNATIVES TO HELP REDUCE
OPIOID USE AFTER CAESAREAN
SECTION.
A HIGH PROPORTION OF PEOPLE WHO
HAVE CAESAREAN SECTIONS GO ON TO
DEVELOP OUD, UNFORTUNATELY AND
THERE'S 1 LARGE TRIAL TO PAIN
MANAGEMENT AND END STAGE KIDNEY
DISEASE WHERE CHEMODIALYSIS IS
THE FOCUS OF PAIN MANAGEMENT
THERE AND A LITTLE BIT LATER WE
ADDED THE EMPOWER STUDY WHICH IS
SOMETHING THAT THE MDWG HAD KEPT
REMINDING US THAT WE NEED TO
LOOK AT HOW TO MANAGE PEOPLE
WITH BOTH PAIN AND OUD AND
EMPOWER IS DOING THAT AND THEY
HAVE LIFE STUDIES EMBEDDED IN
MULTIPLE TRIALS TO LOOK AT
STUDIES TO TREAT PEOPLE WHO HAVE
OPIOID USE DISORDER AND CURRENT
PAIN AND THEN WE HAVE A
BIOMARKER PROGRAM THAT'S
EVOLVING, STARTED OUT AS AN
EARLY PROGRAM TO DEVELOP
DIAGNOSTIC MARKERS FOR PAIN AND
DIFFERENT CONDITIONS AND THEN
MOVING INTO ANOTHER PROGRAM THAT
WAS MORE TAIL LORA RODRIGUEZED
TO DEVELOPING BIOMARKERS FOR
TRIALS AND THEN WE'LL TALK TODAY
ABOUT A NEW 1 THAT IS QUITE
WEARABLE FOR BIOMARKER DEVICES.
BIG PROGRAM ON HEALTH EQUITY AND
MAIN AND POPULATIONS WITH HEALTH
DISPARITIES AND THIS 1 HAS 11
TRIALS THAT HAVE ALREADY STARTED
INTO THEIR PHASE 1 PLANNING AND
THEN WE'VE GOT GROUPS AND WE
HAVE A NUMBER OF DIFFERENT
APPLICATIONS SORT OF IN THE
REVIEW PROCESS FOR THE NEXT 3 IN
THE SET FOR SICKLE CELL DISEASE
PAIN MANAGEMENT ACCIDENT THIS
CAN BE ACUTE OR PROPONENTIC PAIN
AND THEN PAIN MANAGEMENT IN
PEOPLE WHO LIVE IN RURAL
POPULATIONS WE KNOW PAIN IS
HIGHER--MORE HIGHLY PREVALENT IN
RURAL THAN URBAN POPULATIONS AND
THEN ANOTHER PROGRAM THAT'S
LINKED INTO THE POWER STUDY THE
MULTILEVEL INTERVENTIONS FOR
THOSE ON OPIOIDS SO THIS IS
MANAGING PAIN IN PEOPLE WHO ARE
AT RISK FOR OPIOID USE DISORDER
THAT HAVE BEEN ON OPIOID
THERAPIES.
SO AGAIN, THESE ARE APPROVED, WE
HAVE APPLICATIONS IN AND HOPE TO
BE ABLE TO TELL YOU MORE ABOUT
WHAT THOSE TARGETED APPLICATIONS
FOR AWARDS WILL BE.
SO THE 1S WE WILL TALK ABOUT
TODAY IS IN LIGHT BLUE, THESE
ARE APROGRAMS FOR ACUTE AND
CHRONIC PAIN MANAGEMENT IN
CHILDREN, 1 TO BEEF UP OUR
WORKFORCE IN THE PAIN RESEARCH
ARENA, THE WEARABLE DEVICES, I
MENTIONED SLEEP AND THE REISSUE
OF THE BIOMARKER FOR MY'S FACIAL
PAIN.
THE NEXT SLIDE GIVES YOU A VERY
HIGH LEVEL OVERVIEW OF ALL THESE
DIFFERENT CLINICAL PAIN STUDIES
WHETHER THEY ARE BIOMARKER
VALIDATION STUDIES IN HUMANS,
WHETHER THEY'RE CLINICAL TRIALS,
OR WHETHER THEY ARE LONGITUDINAL
STUDIES AND LOOKING ACROSS THOSE
STUDIES HOW MANY STUDIES ARE
LOOKING AT DIFFERENT PAIN
CONDITIONS SO THIS CHART GIVES
YOU AN OVERVIEW OF CHRONIC PAIN
IN GENERAL, IT'S OBVIOUSLY THE 1
WITH THE HIGHEST, THIS IS SORT
OF NOT A SPECIFIC PAIN
CONDITIONING STUDY, AND BACK
PAIN, HIGHLY PREVALENT ACROSS
THE WORLD AND SO, THAT 1 HAS
ONGOING STUDIES AS WELL AND YOU
CAN LOOK ON YOUR WAY DOWN THE
CHART TO SETHAT SOME CONDITIONS
HAVE NOT YET BEEN SPECIFICALLY
ADDRESSED BUT MIGHT FIT INTO
CHRONIC PAIN OR BACK PAIN BUT
THIS GIVES YOU THE TYPE OF PAIN
CONDITIONS INCLUDED BETTER
INTERNAL AUDIT CLUEDED IN THE
PORTFOLIO AND LAST TIME WHEN WE
LAUNCHED INTO THE NEW CONCEPTS,
NEXT 1, PLEASE, GIVES YOU--NEXT
SLIDE, THANK YOU.
GIVES YOU A SENSE OF THE
INTERVENTIONS THAT ARE BEING
TESTED IN THE DIFFERENT TRIALS
ACROSS HEAL AND IN THE DIFFERENT
SETTINGS WHERE THESE TRIALS ARE
TAKING PLACE.
SO THIS SET OF APPLICATIONS, SET
OF AWARDS RATHER DOESN'T INCLUDE
THE BIOMARKERS FOR LONGITUDINAL
STUDIES BECAUSE THOSE ARE NOT
INTERVENTIONAL.
THESE ARE SORT OF CATEGORIES
THAT WE HAVE PULLED TOGETHER
FROM LARGER GROUPINGS OF THE
TYPES OF INTERVENTIONS SO THIS
IS KIND OF HIGH LEVEL, BEHAVIOR
HEALTH WOULD INCLUDE MINDFULNESS
AND CBT AND SOME OTHER TYPES OF
INTERVENTIONS THERE.
AND EXERCISE COULD BE THROUGH A
PHYSICAL THERAPIST OR YOGA OR
OTHER TYPES OF PROGRAMS.
SO AGAIN, HIGH LEVEL TO GIVE YOU
A SENSE OF THE BREDTH OF THE
TYPES OF INTERVENTIONS THAT ARE
INCLUDED SOME ARE
PHARMAICOLOGICAL, SOME ARE NOT,
SOME ARE INTERVENTIONAL, AND THE
BREDTH OF SETTINGS, PAIN IS
TREATED IN A NUMBER OF DIFFERENT
PLACES AND THEY THINK HEAL
APPROPRIATELY HAS A GOOD RANGE
OF SETTINGS FOR THE CLINICAL
TRIALS THAT ARE GOING ON ON
THROUGH THE PROGRAM.
SO WITH THAT AS A LITTLE BIT OF
BACKGROUND FOR THE BEDTH THAT WE
HAVE READY, JANE IS GOING TO
PICK UP THE NEXT WITH THE NEXT
SLIDE, THE FIRST OF THE CONCEPTS
THAT WE ARE PRESENTING SO WE
HAVE 6 DIFFERENT CONCEPTS WE'RE
PRESENTING TODAY.
SO I WILL TOSS IT TO JANE AND WE
WILL PICK UP THERE.
>>THANK YOU LIBDA.
NEXT SLIDE.
I HAVE THE PLEASURE OF
PRESENTING THE HEAL KNOWLEDGE
INNOVATION AND DISCOVERY STUDIES
PAIN INITIATIVE ALSO KNOWN AS
HEAL KIDS, THE BACKGROUND FOR IT
IS ACUTE AND CHRONIC PAIN IN
CHILDREN AND ADOLESCENTS ARE
COMMON AND OFTEN UNDERRECOGNIZED
SO SELF-ORDER OF MICRONS MEASURE
AND INCONSISTENTLY TREATED.
STUDIES SUGGEST A CHRONIC PAIN
IS EXPERIENCED BY APPROXIMATELY
1 QUARTER TO ONE-THIRD OF
CHILDREN AND UNTREATED PAIN CAN
LEAD TO LONG-TERM ADVERSE
OUTCOMES.
IN FACT, THE RESEARCH, REISSUE
OF THE CDC GUIDELINES FOR
PRESCRIBING OPILOT PROJECT
OITDOIDS DOESN'T HAVE ANY
RECOMMENDATIONS FOR THOSE UNDER
THE AGE OF 18, SO TO ADDRESS
THIS GREAT CLINICAL NEED FOR
BETTER MANAGEMENT OF PAIN IN
CHILDREN, THIS CONCEPT HAS BEEN
DEVELOPED WHICH HAS 3
COMPONENTS.
THE FIRST IS A KARKS CUTE
CLINICAL TRIAL COMPONENT.
THIS WILL FUND IMPROVEMENT THE
ASSESSMENT MANAGEMENT AND ACUTE
TREATMENT OF PAIN IN PEDIATRIC
PATIENTS ACROSS THE SPECTRUM OF
CARE USING INNOVATIVE CLINICAL
TRIAL DESIGNS.
THE SECOND COMOPPOSITE
BEHAVIORIAL PHENOTYPE SEPTORS A
CHRONIC PAIN EVALUATION AND
MEASUREMENT COMPONENT AND THERE
IS A NEED TO IMPROVE THE CURRENT
AND/OR CREATE NEW ROBUST
VALIDATED AGE APPROPRIATE
CHRONIC PAIN MEASUREMENTS AND
APPROACHES FOR USE IN CLINICAL
RESEARCH AND PRACTICE.
TO ACCOMPLISH THESE GOALS, THIS
COMPONENT WILL UTILIZE
LONGITUDINAL STUDIES AND THEN
THERE IS A RESOURCE AND
COMPONENTS CENTER, AND IT IS
SHARED CENTER TO FACILITATE DATA
COLLABORATION AND SHARING ACROSS
THE COMPONENTS AND THE
INVESTIGATOR GROUPS INCLUDING
DEVELOPING COMMON DATA ELEMENTS
WHICH REALLY HAVE NOT BEEN
DEVELOPED FULLY FOR CHILDREN,
COMMON ARK --ASSESSMENT AND
MEASUREMENT TOOLS AND DATA
MEASURING STANDARDSA WELL AS
CLINICAL TRIAL COORDINATING
CENTER UNIT.
SO NEXT SLIDE.
THIS SCHEMATIC WAS DRAWN BY THE
DEVELOPER OF THIS CONCEPT AND
THIS NICELY LAYS OUT HOW THESE 2
COMPONENTS ARE JOINED AND THE
ACUTE PAIN TRIALS PROGRAM HELPS
TO DEVELOP OR GENERATE ROBUST
EVIDENCE TO DEVELOP
EVIDENCE-BASED MANAGEMENT AND
TREATMENT GUIDELINES FOR ACUTE
PAIN IN DIFFERENT AGE GROUPS AND
SETTINGS.
THE OVERALL GOAL OF THE CHRONIC
PAIN RESEARCH PROGRAM IS TO
DEVELOP PRECISION MEASUREMENT
TOOLS FOR CHRONIC PAIN IN
CHILDREN.
THEY WILL AWLTS LOOK AT CHRONIC
PAIN RISK FACTORS INCLUDING
HEALTH EREQUESTITY AND SOCIAL
DETERMINANTS OF HEALTH
CONSIDERATIONS, BEHAVIORIAL
ASPECTS RELATED TO PAIN
SEVERITY, DURATION, TREATMENT
RESPONSE, AND RISK OF MENTAL
HEALTH DISORDERS.
ALL STUDIES WILL AIM TO ENROLL
DIVERSE POPULATIONS AND CONSIDER
HEALTH EQUITY AND SOCIAL
DETERMINANTS OF HEALTH IN THEIR
DESIGNS.
SO NEXT SLIDE.
SOPHISTICATED HOW DOES THAT
LARGE CONCEPT FIT WITHIN AND
COMPLEMENT CURRENT PROGRAMS.
THE ACUTE PAIN CLINICAL TRIALS
WILL FILL A LITERATURE GAP,
IMPROVE PATIENT OUTCOMES AND
PROVIDE EVIDENCE FOR CDE
DEVELOPMENT AND COMMON
PROTOCOLS.
THE CHRONIC PAIN EVALUATION AND
MEASUREMENT STUDIES WILL INFORM
PEDIATRIC PAIN OUTCOME AND
MEASURES ACROSS DISEASES AND
CONDITIONS.
WE BELIEVE DEVELOPING OUTCOME
MEASURES AND INTEGRATING DATA
ANALYSIS INTO THIS CONCEPT MAY
CONTRIBUTE OR MAY ACCELERATE
NONDRUG DEVELOPMENT AND TESTING
IN ADOLESCENTS WITH CHRONIC
PAIN, RIGHT NOW WE OFTEN JUST
TREAT CHILDREN AND SMALL ADULTS
WHICH IS PROBABLY NOT
APPROPRIATE, AND ALL STUDIES
WILL CONSIDER THE
BIOPSYCHOSOCIAL MODEL OF PAIN
AND EMPHASIZE SOCIAL
DETERMINANTS OF HEALTH AND
SOCIAL NEEDS WHICH ARE CRITICAL
TO OUR UNDERSTANDING OF PAIN
EXPERIENCES, ADDRESSING HELT
DISPARITY, HEALTH DISPARITIES
AND DEVELOPING EFFECTIVE
INTERVENTIONS.
SO WE HAVE DISCUSSION QUESTIONS,
NEXT SLOYD.
THERE ARE ANY PARTICULAR
STAKEHOLDERS THAT SHOULD BE
INGAUGED TO INSURE THE SUCCESS
OF THESE STUDIES AND I'M GOING
TO OPEN IT TO INVITATIONS TO
DISCUSSION WITH DR. LINDA BARR,
I DON'T KNOW IF LINDA IS ON?
>>I DON'T THINK LINDA WAS ABLE
TO MAKE IT.
>>OTHER DISCUSS ANTS?
DR. SMITH?
>>WELL, TO SAY THAT THERE'S A
DIRGT OF INFORMATION ABOUT
TREATING PAIN IN CHILDREN IS
REPETITIVE, AND MY AREA OF
INTEREST IS SICKLE CELL DISEASE
SO I'LL COMMENT THAT I'M
PARTICULARLY INTERESTED IN THE
PROGRESSION OF PAIN OF SICKLE
CELL DISEASE IN CHILDREN.
FROM MOSTLY ACUTE MANIFESTED BY
VISITIS FOR [INDISCERNIBLE]
CRISIS TO SOMEWHERE AROUND 14-20
YEARS OF AGE, MOSTLY CHRONIC AND
ADDED TO THAT ACUTE PAIN ARE 3
POSSIBLE HYPOTHESIZED
COMPLICATIONS.
ONE IS CHRONIC NEUROPATHIC PAIN
CENTRALLY AND/OR PERIPHERALLY
FROM DAMAGED DUE TO THE SICKLE
CELL DISEASE ITSELF.
SECOND IS OPIOID ALGESIA AND
THIRD IS CHRONIC ORGAN PAIN AND
DYSFUNCTION PARTICULARLY BONE
PAIN DEE TO BONE DISEASE, LEG
ULCERS AND OTHER ESCHEMIC
COMPLICATIONS AND WE HAVE NO
THEORY OR EVIDENCE FOR THAT
PROGRESSION.
SO, IMAGINE DOING THAT SAME
THING FOR DIABETES, IMAGINE
DOING THAT SAME THING FOR OTHER
CONGENITAL DISEASES WHICH MAY OR
MAY NOT BE PAINFUL AT THE START
BUT THEN AFTER YEARS AND YEARS
OF TREATMENT AND ORGAN
DYSFUNCTION BECOME MULTIPAINFUL
DISEASES OR PICK
MULTIMECHANISTIC PAINFUL
DISEASES.
>>THANK YOU AND I'M TAKING LOTS
OF NOTES.
DR. PACE DID YOU WANT TO MAKE
ANY COMMENTS.
>>NO, I'M NOT SURE WE HAVE THEM
EITHER?
>>HOW ABOUT I KNOW DR. HENRY
YOU'RE ON.
>>YES, I AM.
THANK YOU JANE.
AS OF 5:30 LAST NIGHT, THANK
YOU.
SO I'M VERY EXCITED ABOUT THIS
PROJECT BECAUSE THERE IS AN
ABSOLUTE BREDTH OF KNOWLEDGE IN
HERE AND I THINK IN PARTICULAR
INVITING APPLICATIONS THAT WILL
HELP US EVALUATE APPLICATIONS
FOR KIDS THAT ARE NONVERBAL AND
THOSE WITH INTELLECTUAL
DISABILITIES THOSE ARE
CHALLENGING CLINICAL SITUATIONS
AND WE DON'T KNOW WHAT TO DO SO
IF WE CAN GET A BASE LINE, IT'S
HARD TO DECIDE IS THE TREATMENT
BEING SUCCESSFUL OR NOT.
I'M EXCITED BECAUSE WHAT YOU'VE
OUTLINED HERE, YOU'RE DESCRIBING
LOOKING AT FAMILIES SYSTEMS SO
THE WHOLE BIOPSYCHOSOCIAL
COMPONENT, NOT JUST THE PATIENT
BUT OF THE FAMILY BECAUSE I
THINK FAMILIES WITH CHILDREN WHO
HAVE MEDICAL CONDITIONS OFTEN
THE SIBLINGS ARE IMPACTED AS
WELL AND I THINK THAT'S ALSO
OVERLOOKED COMPONENT HERE THAT
PERHAPS YOU COULD GATHER
INFORMATION ON THAT, AND ALONG
WITH THAT, GIVEN THAT THE
FAMILIES ARE MANAGING A LOT, I
THINK THERE SHOULD BE CAREFUL
ATTENTION PAID TO THE
RECRUITMENT PLAN, WHATEVER
POPULATION OR CONDITIONS YOU MAY
CHOOSE TO STUDY SO IN TERMS OF
STAKEHOLDERS ENGAGING PARENT,
OBVIOUSLY IS ABSOLUTELY CRITICAL
AND AND MAKING SURE THAT THE
SCIENCE IS SERVING THE CHILD IN
THE FAMILY AND THE FAMILY AND
CHILD ISN'T JUST SERVING SCIENCE
WHICH IS OFTEN A PERCEPTION THAT
IS OUT THERE WITH THEIR KIDS AND
WHO HAVE MULTIPLE DISABILITIES.
THOSE ARE MY INITIAL THOUGHTS.
I APOLOGIZE FOR MY SORE THROAT,
TOO, I JUST CAUGHT IT FROM
REBECCA.
>>OH NOR, I'M SORRY.
>>I SEE HANDS RAISED BYINANCE
EXPE NEDRA GO,A HEAD NED.
>>THIS MIGHT NOT BE WHAT YOU
HAD IN MIND BUT CROSS CUTTING TO
ADDICTION, IT'S NOT UNCOMMON TO
HEAR THE STORY FROM A YOUNG
ADULT THAT I GOT EXPOSED TO
OPIOIDS WHEN I BROKE MY LEG,
PLAYING FOOTBALL AND AND I HAD A
REMARKABLE RESPONSE TO THEM AND
GOT ADDICTED.
YOU KNOW THERE'S SOME SUBSET OF
KIDS ACUTELY AT RISK TO GO TO TO
BE EXPOSED TO ADDICTION BECAUSE
THEY HAVE A PARTICULAR REACTION
TO THE OPIOID THAT THEY FIND IT
MORE REINFORCING THAN AVERAGE.
SO I WAS WONDERING IF YOU HAVE
IN MIND TO LOOK AT THAT AS PART
OF THIS?
TO WHAT EXTENT IS EXPOSURE TO
OPIATES PARTICULARLY INCREASED
RISK FOR MAIN AND FOR WHOM COULD
WE FIGURE OUT WHICH KIDS ARE AT
RISK.
I THINK THAT WOULD BE PART OF
THE CHRONIC PAIN COMPONENT OF
THIS AND I'LL CERTAINLY PASS
THAT ON TO THE DEVELOPERS OF THE
CONCEPT.
>>THANKS.
SO I HAD 1 SORT OF OFF THE WALL
THOUGHT.
IT SEEMS THAT THIS IS A CASE
WHERE TWIN STUDIES MIGHT BE
EXTREMELY USEFUL.
I KNOW THAT THERE HAVE BEEN TWIN
STUDIES IN THE STUDIES IN THE
PAST BUT HERE THE ISSUE IS, YOU
KNOW YOU GET A HANDLE TO GENETIC
PREDISPOSITION, ENVIRONMENTAL
CONTRIBUTIONS AND I THINK IT'S
BEEN A LONG TIME SINCE TWIN
STUDIES HAVE BEEN DONE FOR PAIN
BUT I WOULD JUST SORT OF PUT IT
ON THE LIST AS SOMETHING THAT
MIGHT BE USEFUL TO IDENTIFY
RELEVANT FACTORS.
>>YEAH, SO, ERIN HAS JUST
POINTED OUT SUZANNEA ARE YOU ON?
WHEN WOULD LIKE TO ADDRESS THAT?
>>YES, IESM --I'M ON.
CERTAINLY THE TWIN STUDIES ARE
EXTREMELY INTERESTING IN VIEW OF
THE FACT THAT THERE SEEMS THERE
ARE SOME CHANGES THAT OCCUR
PRIOR TO THE ONSET OF CHRONIC
PAIN IN CHILDREN THAT CAN BE
OBSERVED WITH IMAGING STUDIES,
WE HAVE NOT, WE ARE PROPOSING TO
RELY ON EXISTING COHORTS TO TAKE
ADVANTAGE OF THE RESOURCES THAT
HAVE BEEN CREATED FOR DIFFERENT
EFFORTS ACROSS THE INSTITUTES
BUT SUDDENLY, THE INCLUSION OF
TWIN COHORTS, IT COULD BE
CONSIDERED ESPECIALLY TO
IDENTIFY RISK FACTORS FOR
CHRONIC PAIN, RISK FACTORS FOR
THE TRANSITION FROM ACUTE TO
CHRONIC PAIN HOW THE EXPERIENCE
OF CHILDHOOD PAIN MAY INFLUENCE
THIS IN CHILDHOOD AND ALL THE IN
ADULTHOOD SO CERTAINLY AN
INTERESTING GROUP OF PATIENTS
AND FAMILY BASED TO CONSIDER TO
BE INCLUDED.
I ALSO WANTED TO ADD THAT IN
TERMS OF SICKLE CELL AND I DON'T
KNOW WITH WENDY WEBER IS ON THE
CALL BUT WE DO HAVE HEAL EFFORT
AND SICKLE CELL DISEASE AND
THERE MIGHT BE OPPORTUNITIES FOR
INTERACTION IF THIS
IBT--INTEGRATISHIAATIVE MOVES
FORWARD WITH THE GROUP OF THESE
IN SICKLE CELL AND WE DO HAVE A
SEPARATE PROJECT I DON'T KNOW
JANE OR LINDA IF YOU WANT TO
COMMENT WHICH WILL BE LOOKING
ALSO AT CHILDREN AND ADOLESCENTS
WHO GET EXPOSED IN PATIENTS TO
OPIOIDS WHO TO ASSESS SOME OF
THE POPULATIONS THROUGH SURVEY
STUDIES AND TO OBSERVE AND GET
DATA ABOUT THE DEVELOPMENT OF
CHRONIC PAIN, SO YOU MAY WANT TO
COMMENT THAT, IF--IS THIS THE 1
SUZANNEA THAT WAS PUT FORWARD BY
THE PREVENTION AND TREATMENT.
>>YEAH, YEAH.
>>SO THIS IS FOLLOWING POST
SURGERY ADOLESCENCE WHO'S
PROCEDURE IS GOING TO INVOLVE
SOME OPIOID EXPOSURE AND
FOLLOWING THEM, FOLLOWING THE
SURGERY.
>>I THINK WE CAN GO TO CHRIS
AND THEN DIANEA, JANE IF YOU
HAVE ADDITIONAL THOUGHTS ABOUT
THAT?
>>NO, I THINK LEVERAGING
WHATEVER EXISTING COHORTS ACROSS
HEAL IS REALLY SOMETHING WE
SHOULD LOOK AT CAREFULLY.
>>THANK YOU.
GO AHEAD CHRIS.
>>THANKS REBECCA SO SUZANNEA
JUST MENTIONED OR TALKED A BIT
ABOUT A COMMENT THAT I'M GOING
TO MAKE WHICH SOUNDS LIKE YOU'RE
ALREADY THINKING ABOUT
ADDRESSING IT BUT CIRCLING BACK
TO THE CONVERSATION WE HAD
EARLIER ABOUT THE TEMPORAL
DEVELOPMENT, OF ACUTE AND
CHRONIC PAIN, THIS POPULATION
OBVIOUSLY THERE'S A GREAT NEED
TO STUDY AND ADDRESS AND HOW TO
TREAT KIDS WHO ALREADY HAVE
CHRONIC PAIN CONDITIONS BUT I
WOULD ENCOURAGE YOU TO LOOK AT
THIS WITH A PREVENTION LENS
BECAUSE YOU KNOW WE KNOW SO
LITTLE ABOUT THE TEMPORAL
DEVELOPMENT OF PAIN AND THERE
CERTAINLY HAVE BEEN A LOT OF
FACTORS THAT HAVE BEEN
IDENTIFIED IN DIFFERENT STUDIES
FOR EXAMPLE, IN GERLS, EARLIER
AGE IN DISMENNOREA ARE IN A
KNOWN RISK FACTOR FOR THE
DEVELOPMENT OF CHRONIC PAIN
LATER IN LIFE, AND SO THE EXTENT
THAT IT'S POSSIBLE, IT WOULD BE
REALLY BE GREAT TO TRY TO USE
THIS PARTICULAR RESEARCH PROGRAM
TO IDENTIFY WHAT THOSE
PSYCHOSOCIAL AND ENVIRONMENTAL
FACTORS MAY BE THAT DO PUT
ADULTS AT RISK OF DEVELOPING
CHRONIC PAIN BUT IT COULD START
A LOT EARLIER IN LIFE.
>>GREAT.
THANK YOU.
AND THEN DIANEA.
>>YEAH, SO I WOULD LIKE TO
THANK THE GROUP FOR THEIR
POSITIVE COMMENTS, THIS IS
CLEARLY AN AREA THAT'S LARGELY
NOT ADDRESSED WITH ANY HEAL
INITIATIVES, I DID WANT TO
COMMENT ON NED'S COMMENT BECAUSE
I'VE ALWAYS WONDERED AS THE
NORMALNYONATOLOGYIST, WHERE IN
THE NICU, WE--THESE ARE NOT THE
BABIES THAT ARE CEREBELLUMS
POSED IN UTERO, BUT BABIES THAT
OFTEN GET OVERMEDICATED TO MAKE
THEM COMFORTABLE WHILE THEY'RE
INTUBATED LET'S SAY OR GET
SUBSTANTIAL MEDICATION PRIOR TO
PROCEDURES, SO THERE'S A
POPULATION THAT HAS ACUTE PAIN
AND THEY'RE NOT VERBAL SO HOW DO
YOU ASSESS PAIN IN NAPOPPULATION
AND WHAT IMPLICATIONS DOES IT
HAVE LONG-TERM SO THAT'S ANOTHER
POPULATION THAT WE REALLY
HAVEN'T DISCUSSED AND THE SECOND
THING IS THESE KIDS HAVE 20, 30,
40 FRACTURES THROUGH ADOLESCENTS
AND IT'S SIMILAR IN MANY WAYS TO
SICKLE CELL BUT THIS--THIS IS
JUST AN INCREDIBLE DISEASE WHERE
HAVING TAKEN CARE OF THESE
PATIENTS, THESE KIDS, THATTENER
CONSTANT PAIN AND WHAT CAN WE
OFFER THEM.
AND I APPRECIATE WHAT CHRIS SAID
BECAUSE DISMENNOREA IS SOMETHING
THAT'S ALSO IN OUR RADAR SCREEN.
SEVERE DISMENNOREA, ALSO LOOKING
AT PREDICTIVE BI ONY MARKERS FOR
ENDOMEET REOSEIS BUT THEY MAY
PRESENT AS CHRONIC MENSTRUAL
PAIN AS PART OF THE PIEWBERAL
DEVELOPMENT.
THANK YOU.
OKAY, I WILL GIVE YOU, SO DIANEA
THANK YOU, SO MANY, SO MANY
AREAS TO EXPLORE AND THEN SHARON
I WILL GIVE YOU THE LAST--
>>I KNOW THIS IS FOCUSED ON
KIDDOS BUT WHAT WE CAN LEARN
ABOUT EVALUATING KIDS WHO ARE
NONVERBAL AND INTELLECTUAL
DISABILITIES AND HOW TO TREAT
THERAPIST PAIN COULD BE VERY
HELPFUL IN HELPING US ADDRESS
PAIN IN THE ELDER LAP, SOME OF
WHOM ARE NONVERBAL AND HAVE
OTHER COGNITIVE ISSUES SO JUST A
PLUG THERE TO USE THE DATA WE
CAN AND USE IT WISELY.
>>THANK YOU.
I SEE THERE ARE A FEW MORE
COMMENTS IN THE CHAT.
FEEL FREE IF YOU HAVE ADDITIONAL
THOUGHTS TO ADD THOSE THERE,
LIPPEDDA AND JANE, I WONDER JUST
CONSIDERING, YOU KNOW YOU HAVE
THE--ABOUT AN HOUR LEFT FOR A
FEW MORE CONCEPTS AND
DISCUSSION, WOULD IT MAKE MORE
SENSE TO KIND OF GO THROUGH WHAT
THE CONCEPTS AND THEN JUST HOLD
A BIG DISCUSSION AT THE END SO
THAT WE'RE NOT INTERRUPTING OR
TRYING TO SWITCH GEARS TOO MANY
TIMES?
>>THAT'S FINE WITH ME, I KNOW
WE WILL BE TIGHT ON TIME SO
MAYBE THE DISCUSSION AT THE END
WILL BE A GOOD THING.
>>OKAY, SO WHY DON'T WE GO TO
THE NEXT SLIDE THEN AND I WILL
START IN ON THE NEXT 1.
>>SO THIS 1 IS ON EXPANDING THE
CLINICAL PAIN WORK HORSE IN THIS
A LEVEL OF TRAINING AS FAR AS
CAREER STAGE GOES THAT WE
HAVEN'T CORED BEFORE, THE NEED
TO BRING IN AND KEEP CLINICAL
PAIN RESEARCHERS HAS BEEN A
CONCERN FOR QUITE A LONG TIME WE
DID A SURVEY ACROSS A NUMBER OF
PROFESSIONAL GROUPS AND LARGE
PROFESSIONAL MEETINGS OF PAIN
RESEARCHERS AND QUESTIONS ABOUT
WHY YOU'RE NOT DOING RESEARCH,
HOW YOU GOT INTO RESEARCH IF YOU
ARE DOING IT AND WHAT WAS
HELPFUL, WHAT DID YOU NEED FOR
SUPPORT TO STAY THERE.
AND SO WHAT WE FOUND WAS THAT
PROTECTED TIME WAS IMPORTANT FOR
PEOPLE WHO ARE MENTORING EARLY
TRAINING, YOUNGER AND EARLY
STAGE CAREERS IS IMPORTANT AND
HEAL HAS A NUMBER OF DIFFERENT
PROGRAMS TO SUPPORT MENTORING
AND TO SUPPORT EARLY STAGE
CAREER RESEARCHERS IN THE
CLINICAL PAIN WORKFORCE.
BUT WHAT WOE DON'T HAVE SO FAR
AND WHAT WE'VE BEEN TOLD BY THE
COMMUNITY IS WHERE WE REALLY
NEED TO START IS WITH THE
FELLOWS AT THEIR--POST DOCTORAL
FELLOWS AT THEIR LEVEL OF CAREER
STAGE AND SO THIS 1 IS A LITTLE
BIT OF A UNIQUE TYPE OF A
TRAINING MENTORS PROGRAM.
TARGETING SYSTEM GETTED TO
PEOPLE AT THAT CLINICAL STAGE
WHO HAVE A DEGREE OR ARE LOOKING
TO DO CLINICAL RESEARCH FROM THE
POST DOCS FORWARD.
SO THE GOAL IS TO BRING IN A
DIVERSE POOL OF HIGHLY TRAINED
SCIENTISTS TO EXPAND OUR
DISCIPLINARY MIN ISSUING
RESEARCH IN SPITE OF THE FUNDS
WE GOT AND THE WONDERFUL WORK
THAT CAN BE DONE THROUGH HEAL,
WE'RE NOT EXPANDING OR EVEN
MAINTAINING OR RESEARCH
WORKFORCE AT THIS POINT.
SO IT'S A POST DOC TRAINING
PROGRAM, USING A MECHANISM
THAT'S A LITTLE BIT UNUSUAL
BECAUSE IT GIVES SUPPORT FOR
PROTECTED TIME FROM MENTORS AND
ALSO SUPPORT TO THE TRAINEES IT
BRINGS THE TRAINEES IN AND KEEPS
THEM TOGETHER OVERTIME AS A
COHORT.
SO THE IDEA HERE IS TO CREATE
THIS TEAM WORK AND POTENTIAL
LONG-TERM COLLABORATIONS AND
ALSO TO TIE THOSE COHORTS INTO
SOME OTHER PROGRAMS THAT WE'RE
ALREADY DOING THROUGH HEAL WHICH
I THINK IS A REALLY IMPORTANT
COMPONENT OF THIS PARTICULAR
CONCEPT.
WE HAVE A HEAL EARLY NETWORKING
PLATFORM, FOR EARLY STAGE
INVESTIGATORS TO HOLD AN ANNUAL
MEETING, BRING THEM TOGETHER,
COLLABORATE, FIND MENTORS, GET
TRAINING AND ALSO TIES THAT IN
TOGETHER WITH A K12 AT THE
NATIONAL LEVEL WHICH HAS BEEN
SET EPIGENETIC AT THE UNIVERSITY
OF MICHIGAN FOR EARLY STAGE
CAREER TRAINEES THAT DON'T COME
FROM UNIVERSITY OF MICHIGAN BUT
COME FROM NATIONWIDE PROGRAMS.
SO THIS IS REALLY TIED INTO OUR
OTHER PROGRAMS TO REALLY WORK
HARD AND HIT ALL THE LEVELS OF
EARLY STAGE CAREERS THAT WE NEED
TO BUILD AND KEEP THIS
WORKFORCE.
THE OTHER THING THAT'S IMPORTANT
ABOUT THIS CONCEPT IS NOT ONLY
IS THE APPLICANT INSTITUTION
REQUIRED TO OFFER TRAINING IN A
TRADITIONAL AREA OF PAIN
RESEARCH, SO, YOU KNOW SORT OF
THE THINGS THAT ANESTHESIOLOGY
OR YOU KNOW WHATEVER WE ARE
CURRENTLY TRAINING IN BUT IT
ALSO HAS TO FOCUS ON
BIOPSYCHOSOCIAL MODEL, AND HAS
REQUIREMENTS FOR DATA SCIENCE,
ET CETERA, THE OTHER PART OF THE
TRAINING PROGRAM THEY HAVE TO
PARTNER WITH A DIFFERENT
DEPARTMENT IN A TRADITIONAL
NONPAIN RESEARCH AREA.
SO PAIN RESEARCHERS NEED TO KNOW
AND WE NEED TO BRING INTO THE
FIELD ENGINEERS, ADDICTION
MEDICINE, PUBLIC HEALTH
SPECIALISTS, MENTAL HEALTH
SPECIALISTS SO THIS THING, THIS
PARTICULAR MECHANISM WOULD TIE
IN WHAT WE THINK OF HAS
TRADITIONAL PAIN RESEARCH
MENTORING SITUATIONS AND OTHER
TYPES AND SO REALLY TO CREATE A
MORE INTERDISCIPLINARY MORE
BROADLY TRAINED COHORT.
AND, THE LAST THING THAT IS A
LITTLE BIT UNIQUE HERE OVER
REGULAR T TRIEP TRAINING
MECHANISM IS THAT WE CAN FUND,
WE CAN SUPPORT TRAINEES WHO ARE
U.S. CITIZEN AND WE CAN ALSO
SUPPORT TRAINEES WHO ARE
FOREIGNERS AND WOULD LIKE TO
STAY IN THE COUNTRY AND DO PAIN
RESEARCH, SO THAT'S AN UNUSUAL
SITUATION.
AND THE NEXT SLIDE.
GIVINGS A LITTLE BIT OF A SENSE
OF HOW THIS WILL ALIGN WITH
OTHER HEAL PROGRAMS AND I
MENTIONED THESE BRIEFLY BUT THE
NETWORKING PROGRAM WHICH IS
CALLED PURPOSE, POSITIVELY UNITE
BE RESEARCHERS TO PROPOSE AND
PAIN, THAT'S WHERE WE CALL IT
PURPOSE, THE ANNUAL MEETING WILL
COME UP THIS SPRING AND THE FOLK
WHO IS ARE IN THE TYPES OF
RESEARCH PROGRAMS THAT WE HAVE
WILL BE REQUIRED TO COME,
THERE'S FUNDING TO SUPPORT THEM,
TO GET THEM THERE, AND THEY CAN
ENGAGE IN A LOT OF DIFFERENT
NETWORKING TRAINING PROGRAMS
THROUGH INTEGRATION WITH THAT
NETWORK AND THE K12 THAT I
MENTIONED WILL HELP WITH SOME
TRAINING RESOURCES BUT AGAIN,
THIS IS REALLY TO BROADLY ENGAGE
PEOPLE ACROSS THE DIFFERENT HEAL
PROGRAMS TO SUPPORT TRAINEES AND
MENTORS SO THE NEXT SLIDE,
QUESTIONS AND PERHAPS WE WILL
JUST COME BACK TO THESE AT THE
END, AND MOVE ON TO THE NEXT 1,
SO I'M REALLY CHANGING GEARS ON
THIS SLIDE.
SO CAN WE REMEMBER THAT, AND
MOVE FORWARD.
WE TALKED ON THE EARLIER PART OF
THIS PRESENTATION, ABOUT THE
BIOMARKER PROGRAM AND THE
DIFFERENT STAGES OF EVOLUTION,
THE HEAL PAIN BIOMARKER PROGRAM
HAS GONE THROUGH, THOSE ARE
STILL ACTIVE, THIS WOULD BE AN
ADDITIONAL--A DIFFERENT APPROACH
TO BIOMARKERS TO DEVELOP
WEARABLE DEVICES TO PULL
OBJECTIVE BIOSIGNATURES NATURES
OR FUNCTIONAL ASSESSMENTS FOR
MONITORING PAIN AND END POINTS
IN PAIN CLINICAL TRIALS.
SO, WE KNOW THAT WEARABLE
DEVICES ARE BEING USED IN
CLINICAL SETTINGS AND
[INDISCERNIBLE], I DON'T THINK
WE HAVE A GOOD SENSE OF WHICH 1S
ARE SENSITIVE, WHICH 1S ARE WELL
VALIDATED AND HAVE BEEN WELL
EXPLORED AS USEFUL TOOLS, SO
THIS--THIS PROGRAM WILL APPROACH
THAT, THOSE--THOSE NEEDS AND SO,
IT'S--A COMBINATION OF MEASURES
DEVELOPMENT OF THESE TOOLS, TO
DO FUNCTIONAL ASSESSMENTS SO
THESE MIGHT BE FUNCTIONAL
MEASURES OF ACTIVITY, OR SLEEP,
OR OTHER THINGS, THAT WOULD BE
IMPORTANT IN MONITORING PAIN
DURING A TRIAL, OR IN THE
CLINICAL CENTER, ULTIMATELY AND
ALSO, TO DEVELOP BIOMARKERS
SIGNATURES FROM PHYSIOLOGICAL
MEASURES THAT CAN BE TAKEN FROM
DIFFERENT WEARABLE DEVICES, AND
SO THERE'S BEENs SOME WORK
DONE IN THAT ARENA IN THE BACP A
C PROGRAM THAT LOOKS PROMISING
AND THAT WOULD OPEN UP THAT TOOL
OR RESOURCE DEVELOPMENT TO OTHER
DIFFERENT TYPES OF PAIN
CONDITIONS.
SO THE OVERALL OBJECTIVE IS TO
BE ABLE TO USE THESE TOOLS BOTH
THE BI OR MARKERS AND MEASURES
TO ENHANCE THE TRIALS AND
ENHANCE IT IS LIKELY SUCCESS OF
TRIALS AND ALSO TO FARRINGET
SPECIFIC INTERVENTIONS TO
PATIENTS, AND AGAIN THIS WAS
WHAT THE BEST TRIAL IS LAUNCHING
TO DO FOR BACP A C.
AND THE DELIVERABLES FOR THE
PROGRAM WILL BE VALIDATED DEVICE
DIVIDED BIOSIGNATTURES TO,A
ASSESSES THERAPEUTICS AND
IDENTIFY NEW CLINICAL END
POINTS, THE PRODUCTS WILL
INCLUDE NOT ONLY THE DEVELOPMENT
OF THOSE DEVICES BUT THE ALGOGHT
RIM IMPEDIMENTSS AND THE
SOFTWARE TO--ALGORITHMS TO
ANALYZE THE DATA THAT CAN BE
TAKE KNOW TO USE THESE DEVICES
AND THAT'S OFTEN A VERY
CHALLENGING AREA BECAUSE IT CAN
BE A LOT OF DATA OVER A LONG
PERIOD OF TIME.
SO THE NEXT 1 I THINK IS THE 1
THAT HOW THIS IS SUPPLYING IS
THESE PROGRAMS AND THEY
HAVE--THE POTENTIAL TO USE THESE
DEVICES IN OUR PHASE 2 EPPIC-NET
STUDIES.
THEY'VE BEEN TALKING THE
DEVELOPERS OF THE CONCEPT WITH
THE BACPARKS AC PROGRAM, THEY'RE
DOING SENSOR TECHNOLOGY
DEVELOPMENT AND WITH AN AIM
TOWARDS OBJECTIVE BIOSIGNATTURES
OR ASSESSMENTS OF END POINTS AND
THEY'VE TALKED TO A NUMBER OF
SMALL FORM SUITICAL COMPANIES,
BIOTECH COMPANIES, THE
SBIRR PROGRAM HAS SOME OF THESE
DEVICES POTENTIA WILY, POTENTIAL
DEVICES GOING INTO DEVELOPMENT
THROUGH THOSE PROGRAMS AS WELL.
WORKING CLOSELY WITH NIBIB,
ALSO.
>>OKAY, SO I THINK IF WE CAN
JUST GO TO THE NEXT SLIDE, WE
CAN LOOK QUICKLY AT THE
SELECTION QUESTIONS THAT WERE
DEVELOPED SO, INDUSTRY,
POTENTIALLY, WE WILL COME BACK
TO THESE, AND THEN HOW THE
INFORMATION CAN GET INTO THE
CLINICAL TRIALS AND INTO
PRACTICE AND WHAT STAKEHOLDERS
DO WE NEED TO ENGAGE?
AND SO LET'S KEEP THOSE IN THE
BACK OF YOUR MIND AND THAT WILL
HELPFULLY LEAD US TO THE NEXT 1
WHICH JANE WILL PRESENT WHICH IS
SLEEP AND PAIN.
>>THANK YOU OUR NEXT TOPIC IS
SLEEP AND CIRCADIAN RHYTHMS AS
INTERVENTION TARGETS FOR ACUTE
AND CHRONIC PAIN SYMPTOMATOLOGY,
PATHOBIOLOGY AND TREATMENT
RESPONSE, SO SLEEP DEFICIENCY IS
A FREQUENT CO-MORBIDITY IN ACUTE
CHRONIC PAIN CONDITIONS AND
EVIDENCE POINTS TO A
BI-DIRECTIONAL RELATIONSHIP
WHERE SLEEP DEFICIENCY
EXACERBATES PAIN SENSITIVITY AND
PAIN TRIGGERS SLEEP
DISPUSHANCES.
THIS CONCEPT WILL EXAMINE
INTERVENTIONS TARGETED AT SLEEP
AND CIRCADIAN DISTURBANCES TO
IMPROVE ACUTE AND CHRONIC PAIN
SYMPTOMATOLOGY, PATHOBIOLOGY AND
TREATMENT RESPONSE AND IT WILL
DELINEATE SLEEP AND CIRCADIAN
RHYTHMS AS DIRECT THERAPEUTIC
TARGETS TO IMPROVE OUTCOMES IN
INDIVIDUALS WITH ACUTE AND
CHRONIC PAIN CONDITIONS.
SO NEXT SLIDE.
SO THIS CONCEPT, FOCUSESSED ON
IDENTIFYING NOVEL INTERVENTION
TARGETS FOR ACUTE AND CHRONIC
PAIN CONDITIONS, IT SHOULD
ADVANCE OUR EVIDENCE BASE
STRATEGIES TO IMPROVE THE
EFFECTIVENESS OF PAIN TREATMENTS
AND CLINICAL OUTCOMES.
IT SHOULD CATALYZE CLINICAL
RESEARCH ON SLEEP AND CIRCADIAN
DISTURBANCES ON A PREVALENT CO
MORIT AND MAIN CONDITIONS THAT'S
NOT CURRENTLY WELL REPRESENTED
IN THE HEAL PAIN PORTFOLIO AND
IT ADDRESSES A POTENTIAL
INTERSECTION BETWEEN PAIN AND
OUD MISUSE, OPIOID MISUSE AND
OUD.
NEXT SLIDE.
SO WE HAVE SOME DISCUSSION
QUESTIONS, WE WOULD LIKE TO KNOW
HOW WE CAN ENCOURAGE NEW
INVESTIGATORS TO APPLY AND
INCREASE THE NUMBER OF
APPLICATIONS FROM SLEEP AND PAIN
RESEARCHERS.
IS THERE AN INDICATION OR ARE
THERE SPECIFIC COMPONENTS OR
MECHANISMS OF SLEEP THAT COULD
BE TARGETED FOR INTERVENTIONS?
SO THOSE WERE OUR DISCUSSION
QUESTIONS.
WE WOULD LIKE TO FOCUS ON DURING
OUR DITION CUSHION SESSION.
--DISCUSSION SESSION.
DISCLOSURE FRAMEWORK PROJECT.
SO LINDA I THINK IT'S BACK TO
YOU.
>>YES, SO WE HAVE 1 MORE TO
PRESENT AND THEN WE CAN GO ON TO
OPEN UP FOR QUESTIONS, NEXT
SLIDE.
THIS IS A PROGRAM THAT YOU
SHOULD BE SOMEWHAT FAMILIAR WITH
BECAUSE IT'S A PROGRAM THAT DID
LAUNCH FOR 2022 AND DEVELOPING
TEAM--DEVELOPMENT TEAM IS
LOOKING TO MAKE SLIGHT CHANGES
AND ASK FOR REISSUE OF THIS
CONCEPT THROUGH A LATER FOA IF
YOU WILL TO ADD ON TO AREAS, ADD
IN AREAS WHERE THAT WEREN'T
NECESSARILY COVERED BY THE FIRST
ROUND OF APPLICATIONS SO LET ME
BACK UP A LITTLE BIT AND GO
THROUGH THE GOALS OF THIS.
MY'S FACIAL PAIN AND BIOMARKERS
OR IMAGING TOOLS TO MEASURE
NORMAL CHARACTERISTICS AND
FEATURES OF MY O FACIAL TISSUES,
SO THE MUSCLE, THE FACIAL
INTERFACE AND THE ASSOCIATED
TISSUES ARE SOMETHING THAT WE
REALLY HAVEN'T TACKLED BEFORE
DESPITE THE FACT THAT MYOFACIAL
PAIN IS PROBABLY A UNDERLYING
ISSUE FOR A NUMBER OF DIFFERENT
PAIN CONDITIONS, IT SEEMS LIKE
HEADACHE, BACK PAIN, TEMP ROMAN
DIBULAR JOINT DISORDER AND MANY
OTHERS, MY O FACIAL PAIN IS
PROBABLY 1 OF THE DRIVING FORCES
OF PAIN.
SO WE NEEDED BETTER WAYS TO
MEASURE THE CHARACTERISTICS OF
THE NEURONAL TISSUE, NORMAL MY O
FACIAL TISSUE AND INTERFACES,
AND ALSO TO LOOK AT TO FIND
TOOLS TO QUANTITATIVELY ASSESS,
WHAT--HOW THOSE STRUCTURES AND
PHYSIOLOGICAL CHANGES OCCUR
AFTER PAIN HAS SET IN, AND SO,
THE EARLY PROGRAM, THE FIRST
ITERATION OF THE MY O FACIAL
TISSUES, WITH 7 DIFFERENT AWARDS
AND THESE COVERED A RANGE OF
DIFFERENT TYPES OF PAIN BUT NOT
AS COMPREHENSIVE AS WE WOULD
HAVE LIKED SO THEY WERE FOCUSED
ON NECK AND BACK PAIN AND
SHOULDER PAIN AND THEY ALSO
COVERED A NUMBER OF DIFFERENT
EXCITING NEW TECHNOLOGIES, SO
THESE ARE QUANTITATIVE
ASSESSMENT TOOLS THAT WE'RE
LOOKING FOR THAT CONSERVE AS
PREDICTIVE BIOMARKERS OF MY O
FACIAL TISSUE CHANGES WITH
HEALTH TO HELP OUT IN TRIALS TO
HELP IN DEVELOPMENT OF NEW
THERAPEUTIC APPROACHES AND SO,
THE TECHNOLOGIES ARE
NONINVASIVE, THEY SPAN A NUMBER
OF DIFFERENT NOVEL AREAS, THAT'S
HELPED THIS PAIN SORT OF
IDENTIFY WHAT TECHNOLOGIES WILL
BE USEFUL IN THIS AREA, AND WHAT
1'S VIA INITIAL SET OF
APPLICATIONS DIDN'T ACTUALLY
COVER AND SO, THE KINDS OF
MEASURES, THE VISCOSITY, TISSUE
STIFFNESS, INFLAMMATION,
CIRCULATION, ADHESION, ET
CETERA, ET CETERA ARE THINGS
LIKE THAT DEALING WITH THAT IN
THE EARLY STUDIES BUT NOT ACROS
A NUMBER OF PAIN CONDITIONS AND
ARE PUBLIC COULD BENEFIT FROM
OTHER TECHNOLOGIES TO COME IN.
AND SO THE ASK IS FOR A REISSUE
AND THIS WOULD BE PRIORITIZING
THINGS LIKE TMD, AND HEADACHE,
PELVIC PAIN, PAIN CONDITIONS
THAT WERE NOT COVERED IN THE
FIRST ITERATION BUT CLEARLY
WOULD BE LINKED TO MY O FACIAL
PAIN.
AND AGAIN, SOME NEW TECHNOLOGIES
THAT COULD BE APPLICABLE TO THIS
PROGRAM SO THE NEXT SLIDE.
>>QUICK QUESTION, LINDA, DOES
THIS RULE OUT O. A.?
>>NO.
IT DOESN'T RULE OUT O. A.
>>BUT IT IS MY O FACIAL TISSUES
BUT I DON'T THINK ANYTHING'S
BEING RULED OUT AS LONG AS
THEY'RE LOOKING AT THE MY O
FACIAL INTERFACE RELATED TO O.
A.
>>OKAY, THANK YOU.
>>AND SO, HERE'S A LIST OF THE
DISCUSSION QUESTIONS THAT WE
THOUGHT WERE APPROPRIATE FOR THE
OPEN DISCUSSION WHICH MEANS, CAN
YOU GO 1 MORE SLIDE, I FEEL LIKE
THE ALIGNMENT 1 IS MISSING HERE.
NOPE, I GUESS NOT, IT'S JUST NOT
IN THE DECK, SO I THINK PERHAPS
AT THIS POINT THEN, WE CAN OPEN
FOR QUESTIONS.
JANE IS ON AND WE HAVE SOME OF
OUR DEVELOPMENT TEAM LEADS IN
THE AUDIENCE AS WELL.
SO JUST TO REMIND YOU, WE HAVE
THE KIDS 1, WHICH WE TALKED
ABOUT HERE A BIT, WE HAVE THE MY
O FACIAL PAIN, WE HAVE THE
WEARABLE DEVICES, WE'VE GOT
SLEEP AND WE HAVE THE WORKFORCE.
>>I FEEL LIKE WE SHOULD
STRUCTURE THIS IN SOME WAY,
THERE'S A LOT TO GET THROUGH.
RATHER THAN JUST LEAVING IT OPEN
TO EVERYTHING.
>>DO WE WANT TO START IN THE
ORDER.
>>LET'S START WITH WORKFORCE.
>>WELL THE'S GO IN ORDER.
>>I HAVE A QUESTION.
I THINK THAT'S A GREAT PROGRAM
AND A REALLY BIG GAP A REAL
OPPORTUNITY IN ALLOWING PEOPLE
WHO ARE NOT NIH ELIGIBLE TO
SERVE AS TRAINEES.
I WONDER A COUPLE THINGS WHAT'S
THE SCOPE OF NUMBER OF TRAINEES
PER SITE?
AND WITH RESPECT TO THE NONU.S.
CITIZEN QUESTION, IS THERE SOME
KIND OF A REQUIREMENT FOR THEM
TO STAY--I MEAN EXPECTATION FOR
THEM TO STAY OR IS THAT JUST NOT
RELEVANT BECAUSE IT'S STILL JUST
BROADLY A PAIN FOR THE CLINICAL
RESEARCH WORKFORCE?
>>YEAH, SO THE EXPECTED NUMBER,
THE HOPED FOR NUMBER WOULD BE 4
OR 5 TRAINEES AT EACH SITE AND
THEN THE THERE WOULD BE MENTORS
AND SO THE MENTORS GET A
PROTECTED TYPE AS WELL AND I
THINK THEY'RE LOOKING FOR A
RATIO OF 4 TO 1, SO 4 U.S.
CITIZEN TO 1 FOREIGN.
IT'S HARD, THE EXPECTATION IS
THAT WE WOULD HAVE PEOPLE WHO WE
HOPE WOULD STAY IN THE COUNTRY
AND BENEFIT OUR WORKFORCE
ENHANCEMENT BUT I'M NOT SURE HOW
EASY IT WOULD BE TO JUDGE THAT.
BUT IT IS SOMETHING WE WOULD
LOOK AT, IT WOULD HAVE TO BE
JUSTIFIED AS FAR AS--NOT
JUSTIFIED, THAT'S NOT THE RIGHT
WORD BUT, YOU KNOW I GUESS YOU
COULD COME UP WITH QUESTIONS FOR
THEM, HOW LONG HAVE YOU BEEN
HERE, HOW LONG TO YOU EXPECT TO
STAY, ET CETERA.
>>RHYME NOT SURE WHAT YOU CAN
DO TO PUT TEETH IN THAT BUT JUST
YOU'RE COULD YOU SAY WHAT IT
WAS.
I VERY MUCH SUPPORT THIS
PROGRAM.
I THINK THAT WOULD BE A HUGE
BENEFIT.
>>THANKS, RALPH.
ANYBODY ELSE ON THIS 1?
SHARON YOUR HAND IS UP.
>>YES, SO LINDA WHAT THOUGHT
HAVE YOU GIVEN TO THE MENTEE OR
THE TRAINEES WHO HAVE CLINICAL
DEGREES ALREADY, FROM QUHA
PROCESSIONS ARE YOU RECRUITING
OR HOW DO YOU DEFER THERE, YOU
DON'T WANT ALL PHYSICIANS, YOU
DON'T WANT 1 TYPE OF CLINICIAN.
>>YES, SO THIS WOULD HOPEFULLY
BE ACROSS THE RANGE AND THESE
ARE CLINICAL DEGREES.
SO, YOU CAN GO FROM
PSYCHOLOGISTS TO SOCIAL WORKERS,
EARLY STAGE--WHAT AM I MISSING
HORMONE SO ACROSS ALL
DISCIPLINES WOULD BE ELIGIBLE
BUT IT HAS TO BE AT THE POST DOC
FELLOWSHIP STAGE TO MAKE SURE
WE'RE GETTING REALLY EARLY
PEOPLE IN HERE AND IF WE GET A
NUMBER OF DIFFERENT AWARDS, THE
HOPE IS THAT WE WILL BE ACROSS A
NUMBER OF DIFFERENT TYPES OF
DISCIPLINES BUT ALSO BECAUSE
WE'RE ASKING FOR A PARTNERING
BETWEEN NONTRADITIONAL PAIN
AREA, WE HOPE WE CAN GET PEOPLE
IN WHO ARE ANTHROPOLOGISTS,
STATISTICIANS WHO ARE INTERESTED
IN CLINICAL RESEARCH AND
HOPEFULLY THIS KIND OF A
TRAINING PROGRAM WOULD GET THEM
INTERESTED, WOULD GET THEM
TRAINED AND HOPE THAT THEY WOULD
BE RETAINED AND MOVE FORWARD
INTO FURTHER AREAS.
AGAIN, NO GUARANTEES THEY'RE
GOING TO LEARN ALL THIS AND BE
MENTORED AND THEN MOVE INTO
SOMETHING COMPLETELY DIFFERENT.
>>RIGHT.
ONE THOUGHT.
IF YOU GO BACK TO YOUR SLIDE ON
NUMBER 41 WHERE YOU SHOWED ALL
OF THE SETTINGS IN WHICH
PATIENTS WITH PAIN OR CHRONIC
PAIN ARE SEEN, IT SEEMS LIKE YOU
WOULD WANT TO GET A DIVERSE
REPRESENTATION OF THOSE CLINICAL
PROFESSIONS.
IT'S ALL THE 1S THAT YOU NAMED
PLUS THE NURSES, THE PTs,
OTs, PSYCHOLOGISTS, CASE
MANAGERS AND SO FORTH SO THAT'S
JUST 1 THOUGHT AND IT'S--IT'S
IT'S TOUGH TO EMPELEMENT THAT
BECAUSE THE PATIENT INTERACTING
WITH ALL THESE PEOPLE, IT'S NOT
JUST THE PAIN ANESTHESIOLOGIST
AND SO FORTH.
THE OTHER THING IS TO TRY AND
AMPLIFY THIS INVESTMENT, CAN THE
TRAINEE THEN HAVE SOME SORT OF
OBLIGATION TO--DURING THE PERIOD
UNDER WHICH HE OR SHE IS COVERED
BY THE FELLOWSHIP, HAVE SOME
SORT OF OBLIGATION TO GO INTO
THE CLINIC OR GIVE LECTURES OR
TRAIN CLINICIANS FROM THESE
VARIOUS DISCIPLINES, BECAUSE,
YOU KNOW THE MESSAGE, WE HAVE TO
GET THE MESSAGE OUT TO THE FRONT
LINE CLINICIANS, STILL.
I MEAN ALAN RAISES A GREAT POINT
THAT WE DON'T HAVE LOSS OF
CLINICIAN REPRESENTATION ON
CERTAIN CONFERENCES ON PAIN,
THAT'S ABSOLUTELY TRUE.
PRIMARY CARE PROVIDERS PRACTICE
DOCS, ET CETERA, SO WITH THESE
MENTEES COULD AT LEAST THEN GO
OUT AS PART OF THEIR WORK
ASSIGNMENT AND ADDRESS THAT,
THAT WOULD BE A WONDERFUL
SERVICE.
>>YEAH, SO I REALLY LIKE THAT
IDEA, AND I THINK THAT'S
SOMETHING THAT WE COULD BUILD
INTO A FUNDING OPPORTUNITY
ANNOUNCEMENT THAT AT A CERTAIN
STAGE, AT THE END OF THEIR
TRAINING OR THEIR YEARS OR
WHATEVER THEY COULD FULFILL THAT
OBLIGATION, SO THAT'S A GREAT
IDEA.
AS FAR AS REACHING OUT TO FOLKS
WHO WOULD BE IN THESE DIFFERENT
SETTINGS, WHETHER IT'S PT, OT,
NURSING, DENTAL, ET CETERA, ET
CETERA, WE WILL HAVE WEBINARS,
AND WE WILL REACH OUT BROADLY TO
MAKE SURE THAT WE COVER THOSE
DIFFERENT DISCIPLINES, TO INVITE
THEM TO LISTEN TO THE WEBINAR
AND MAKE SURE THAT THE
FOA ANNOUNCEMENT GETS OUT THERE
AND I THINK AT SOME POINT POST
REVIEW WHEN WE LOOK AT OUR PAY
PLANS WE TRY TO BALANCE THE
AWARDS THAT ARE MADE AND MAKE
SURE THERE'S A GOOD DIVERSITY
THERE.
SO OTHER THINGS TO CONSIDER.
>>AND THEN THE LAST IDEA, YOU
KNOW ALAN'S VIDEO WAS GREAT
WHERE HE HAS HIS TRAINEES GO OUT
AND THE BASIC SCIENTIST TALKS TO
THE CLINICIAN AND WATCHES A
CARE, A CARE EPISODE BUT
PATIENTS INTERACT, I THINK WOULD
MAKE THAT MORE INNOVATIVE WOULD
BE TO HAVE TRAINEES GO INTO THE
CLINICAL SIMULATION LAB WHERE
SCENARIOS ARE SET UP AND THE
TRAINEE OBSERVES WHEN THE
PATIENT INTERACTING WITH THE
PRIMARY CARE DOCTOR WITH THE
PHYSICAL THERAPIST, WITH THE ET
CETERA, ET CETERA, WITH THE
PSYCHOLOGIST BECAUSE I THINK 1
OF THE THINGS THAT HAPPENS ON
THE FRONT LINES IS THAT PATIENTS
HEAR DIFFERENT MESSAGES FROM
DIFFERENT PROVIDERS AND WE IN
FACT ARE CONTRIBUTING TO THE
DISABILITY ASSOCIATE WIDE
CHRONIC PAIN BECAUSE WE AS
PROVIDERS AREN'T GIVING A
UNIFIED MESSAGE.
SO FOR TRAINEES TO SEE THAT THEN
THEY COULD BE PART OF, HELP TO
BE PART OF THE SOLUTION OVER
TIME SO THOSE ARE MY 3 BIG IDEAS
BUT VERY EXCITING ABOUT THIS.
THIS IS GREAT.
YOU SEE HOW MUCH GRAY HAIR IS ON
THIS CALL, WE DEFINITELY NEED
THIS.
>>WELL, THANK YOU FOR YOUR BIG
IDEAS, WE WILL PASS THEM ALONG.
CHRIS, THEN ED.
>>SURE.
OBVIOUSLY VERY SUPPORTIVE OF
THIS PROGRAM AND PART OF THE K12
AT UNIVERSITY OF MICHIGAN,
ADVISORY COMMITTEE THERE, I WAS
WONDERING IF YOU COULD TALK FOR
A MINUTE ABOUT MORE ABOUT THE
OVERSIGHT OF THESE 3 PROGRAMS.
MY UNDERSTANDING AND THEN THE
SECOND PART OF IT IS HOW THEY
MAY GROW OVER TIME BECAUSE MY
UNDERSTANDING RIGHT NOW LIKE
WITH THE K12 THAT WE MAY BE ABLE
TO SELECT 2 OR 3, MENTEES AT
THIS POINT.
SO I'M PART OF THAT, I READ
ABOUT THE PURPOSE NETWORK AND I
SEE THE PRESENTATION OF THIS,
NEW, PROGRAM, IS THERE GOING TO
BE OVERSITE WITHIN YOUR OFFICE
OR HEAL OR NIH TO MAKE SURE THAT
ALL THESE PROGRAMS ARE ARE, EVEN
THOUGH THEY HAVE A BIT DIFFERENT
OF A SCOPE, THERE'S OBVIOUSLY
OVERLAP AND THEY'RE MAXIMALLY
COORDINATED.
>>YEAH, SO 1 THING THAT WE
THINK IS REALLY IMPORTANT FOR
THIS NEW PROGRAM, IF IT DOES GO
THROUGH, IS THAT IT DOES GET
ALIGNED WITH THE PURPOSE
PROGRAM, WHICH IS THE NETWORKING
PROGRAM AND THAT THERE'S
ACTUALLY BUILT INTO THE ASK FOR
THE BUDGET FOR THIS FOR
SUPPLEMENTAL FUNDS BECAUSE WHEN
PURPOSE WAS FIRST ESTABLISHED,
WE DIDN'T EXPECT THAT WE HAVE
ANOTHER WHOLE COHORT OF TRAINEES
THAT THEY COULD SUPPORT FOR
THEIR MEETINGS AND THINGS LIKE
THAT.
THERE IS NOT CURRENTLY AN
EVALUATION OF THE 3 PROGRAMS,
THERE ARE INDIVIDUAL EVALUATIONS
FOR THE K12 AND THE PURPOSE THAT
ARE LINKED TOGETHER.
WE ARE STILL IN CONVERSATIONS
ABOUT THE EVALUATION OF THE
SUCCESS OF THIS PROGRAM AND I
THINK THAT WAS 1 OF THE
DISCUSSION QUESTIONS AND HOW WE
MIGHT LINK THAT TO THE OTHER
PROGRAMS BUT CERTAINLY, YOU KNOW
THERE'S OVERSITE HERE, AND MEANS
TO MONITOR THE SUCCESS OF THE
TRAINEES AS THEY GO OUT.
THE MENTORING EVALUATION THAT'S
CURRENTLY BUILT IN IS INTERNAL
FOR THIS PARTICULAR PROGRAM, NOT
FOR THE OTHER 2 BUT FOR THIS 1.
>>GREAT.
AND THEN IN TERMS OF LIKE
EXPANSION, IT'S GREAT WE ARE
STARTING THESE, WE HAVE A
WORKFORCE ISSUE DOING 2 TO 3
MENTEES IN 1 PROGRAM AND MAYBE A
HANDFUL IN ANOTHER, I MEAN YOU
HAVE TO START SOMEWHERE BUT IT
SEEMS LIKE WE NEED TO
EXPONENTIALLY INCREASE THAT
NUMBER IN A VERY SHORT PERIOD OF
TIME IF WE'RE GOING TO
ADEQUATELY ADDRESS THE WORKFORCE
ISSUE, RIGHT?
SO I'M JUST CURIOUS IF THERE'S
CONVERSATIONS ARE THESE LIKE
TRIAL PROGRAMS WHICH WILL THEN
BE EVALUATED TO SEE WHETHER
THEY'RE GOING TO BE EXPANDED OR
NOT?
>>YEAH, SO I THINK THE HOPE IS
FOR THE K12 SPECIFICALLY IS
THAT'S MODELED ON NATIONAL K12S
THAT WE HAVE FOR NEUROSURGERY
AND ON PEDIATRIC NEUROLOGY AT
NINDS.
IF YOU BUILT-IN A CERTAIN NUMBER
OF TRAINEES COMING IN ALL THE
WAY THROUGH THE PROGRAM, THEN
THE HOPE IS IF THE PROGRAM IS
SUCCESSFUL, THAT THE NEXT
ITERATION WILL TAKE THEM INTO
THE NEXT ITERATION IF IT'S
SUCCESSFUL AND THE FIELD STILL
WANTS TO SUPPORT IT, SO IT WOULD
BE AN CONTINUOUS EXPANDING,
INSTEAD OF LIKE OVER 5 YEARS,
YOU WOULD USUALLY INCREASE YOUR
COHORT AND DECREASE IT BECAUSE
YOU HAVE A LIMITED AMOUNT OF
MONEY TO GET PEOPLE THROUGH THE
END, SO IN SOME WAY THEY'RE
STRUCTURED WITH THE HOPE AND
EXPECTATION THAT THEY'LL KEEP
GOING BUT AGAIN, WE HAVE TO SEE
IF THEY'RE SUCCESSFUL AND I
MEAN, SO FAR, I THINK THERE'S A
LOT OF EXCITEMENT FOR THE
PURPOSE PROGRAM AND THAT
ACCOUNTED BE THE LINK THAT
REALLY KEEPS ALL THESE TOGETHER
AND REALLY BRINGS A WHOLE NEW
FUTURE RESEARCH GROUP AT SOME
LINK AT SOME POINT IN THEIR
LIVES.
ED?
>>YEAH, JUDGE OF THE A VERY
CONCRETE QUESTION, I THINK I
KNOW THE ANSWER TO BUT THE
T90/R90 PROGRAM 1 OF THE ISSUES
WAS ATTRACTING PHYSICIANS INTO
RESEARCH CAREERS, IS THAT THESE
TRAINING GRANTS DON'T PROVIDE A
COMPETITIVE SALARY.
I TAKE IT THAT THE T90/R90 IS
THE SAME SALARY LEVELS FOR
TRAINEES AS THE T32s.
OR IS THERE MORE FLEXIBILITY?
AND THIS MAY BE SOMETHING WE
CAN'T DO ANYTHING ABOUT BUT
ANYTHING TO MAKE IT A LITTLE
MORE FLEXIBLE, HOW YOU CAN PAY
TRAINEES, PARTICULARLY CLINICIAN
TRAINEES, PHYSICIAN TRAINEES,
ESPECIALLY WHO CAN MAKE A LOT OF
MONEY DOING CLINICAL WORK.
>>YEAH.
>>IT COMPETES.
>>YEAH, THIS 1 IS EARLIER ON SO
IT'S NOT SO MUCH LINKED TO
PHYSICIAN LEVEL SALARY SUPPORT.
THE LATER PROGRAMS ARE LIMITED
AND WE HAVE CAPS ON THE SALARY
BUT THIS 1 IS POST DOC AND IT'S
NOT GOING TO COVER ALL THE
SALARY.
I DON'T KNOW IF THOSE
LIMITATIONS ARE BUILT IN OR IT'S
A BUDGETARY ISSUE, I THINK IT'S
A BIT OF A COMBINATION OF BOTH.
I CAN FIND OUT WHAT THE LIMITS
ARE AND HAVE--UNLESS, I DON'T
THINK [INDISCERNIBLE] AS YOU
KNOW.
>>I AM ON IF YOU WANT ME TO
QUICKLY JUMP IN.
>>YEAH.
>>THE POST DOCKERS FOR THE T90
AND R90 ARE LIMITED TO THE NRSA
SALARY CAP SO IT WOULD BE THE
SAME POST DOC SOLRYS AS THE
T32S.
>>THANKS, LAURA.
WE DON'T HAVE ANY WAY AROUND
THAT, NOT AT THIS POINT.
>>SO WHEN WE SAY CLINICAL, AND
WE EXPAND THAT TO PEOPLE WHO ARE
WORKING IN A CLINICAL
REQUIREMENT BUT DON'T HAVE AN M.
D. BECAUSE THOSE PEOPLE'S
SALARIES ARE CHEAPER?
>>FOR THIS PARTICULAR 1, YES.
>>SO Ph.D.s CAN BE INCLUDED
THEN?
>>ABSOLUTELY.
YEAH.
>>AND LINDA IT SHOULD INCLUDE
ADDICTION AND I THINK IT SHOULD
BE MADE DLEER THAT NEEDS TO GO
HAND AND HAND.
>>YEAH, WE'VE BEEN WORKING ON
GETTING THAT LANGUAGE INTO THE
FOA, LORA'S BEEN WORKING HARD ON
THAT BECAUSE I THINK IT'S
ESSENTIAL AND AN ADDICTION
PROGRAM COULD SERVE AS THE
PARTNERING WITHIN AN INSTITUTION
WHERE YOU HAVE THE OTHER
DISCIPLINE BESIDE THE
TRADITIONAL PAIN WOULD BE MOST
HELPFUL.
>>I WANT TO COMMENT AND SAY YOU
REALLY GLAD YOU INVOKED THE
DISCIPLINE EVER SOCIAL WORK
BECAUSE SOCIAL WORK PROVIDES THE
MA JO ARITY OF BEHAVIORIAL WORK
IN THIS COUNTRY AND THERE'S VERY
LITTLE ATTENTION BEING PAID IN
SOCIAL WORK IN RESEARCH THANE
DIRECTING CLINICAL TRAINING TO
CHRONIC PAIN, SO I'M GLAD
THERE'S GOING TO BE AN EFFORT TO
TRY TO LOOP IT IN THIS
DISCIPLINE AND I LIKE THE IDEA
OF HAVING THESE RESEARCH
TRAINEES BEING SORT OF CLINICAL
AMBASSADORS IN THEIR FINAL WREER
AND HELP TO DO EDUCATION TO
CLINICIANS.
>>ALL RIGHT, THANK YOU VERY
MUCH.
SUPER HELP EMPLOY AND SOME
REALLY, REALLY EXCITING IDEAS SO
PERHAPS SHE SHOULD GO NEXT TO--
>>HEY, LINDA.
JUST TO PIGGYBACK ON WHAT ERIC
IS SAYING PAIN MANAGEMENT IS A
TEAM SCIENCE THESE DAYS.
SO, YOU KNOW WE WERE TALKING
ABOUT THOSE CLINICIANS IN THE
PREVIOUS SESSION WITH MANAGING
CANCER AND RHEUMATOLOGY, WELL,
HELL THEY HAVE PEOPLE WHO REALLY
KNOW WHAT THEY'RE DOING BESIDE
THEM, LIKE ERIC AND OTHER PEOPLE
IN THE BEHAVIORIAL SPACE WHO
THEY TURN TO AND SAY, NOW HELP
ME MANAGE MY PATIENTS PAIN.
SO WE REALLY AREN'T TRYING TO
GET THOSE CLINICIANS TO BECOME A
SOCIAL WORKER OR BECOME A
BEHAVIORIST AS MUCH AS WE'RE
TRYING TO GET THEM TO RECOGNIZE
THE VALUE OF HAVING PEOPLE LIKE
THAT ON THEIR TEAMS AND
INTEGRATING THEM INTO THEIR
TEAMS AND TRAINING UP PEOPLE TO
WORK ALONGSIDE THEM IN THEIR
TEAMS.
NYES, THANK YOU FOR THAT.
ALL RIGHTY WITH THAT, THE NEXT 1
ON THE LIST WAS THE WEARABLES.
FOR THE BIOMARKER PROGRAM.
I THINK AND THEN WE WENT TO
SLEEP, RIGHT?
YES.
SO THIS IS WEARABLE DEVICES P.M.
THAT WILL FIT INTO THE OVERALL
HEAL PAIN BIOMARKER PROGRAM.
AND WE COULD GO--IF WE CAN FIND
THAT SLIDE, I DON'T KNOW WHERE
IT WENT.
>>I'M LOOKING IF ARE IT NOW.
>>I THINK IT'S 2?
>>SO I'LL COMMENT VERY BRIEFLY,
JUST I THINK THIS IS A REALLY
EXCITING AND IMPORTANT PROGRAM.
I THINK THE USE OF WEARABLES TO
DEVELOP THESE BIOSIGNATTURES OF
CHRONIC PAIN, I THINK IS A TON
OF CLINICAL UTILITY, BOTH IN
TERLS OF ITS FORMING, BOTH
PROVIDERS ABOUT THE PROGRESSION
OF THE CHRONIC PAIN CONDITION,
BUT I THINK, MAYBE EVEN MORE
IMPORTANTLY, THERE COULD BE SOME
SORT OF MACHINE LEARNING MODELS
THAT COULD ACTUALLY HELP INFORM
JUST IN TIME INTERVENTIONS THAT
ARE DELIVERED BY [INDISCERNIBLE]
TYPE OF APPROACHES SO I STRONGLY
SUPPORT THIS.
I THINK IT'S A GREAT, GREAT
IDEA.
>>THANKS, ERIC AND PART OF
PRODUCT THAT'S EXPECTED OR
DELIVERABLE FROM THE PROGRAM IS
OLYMPIC GOR RHYTHMS AND
SOFTWARE--
>>BEING ABLE TO PREDICT WHOSE
GAIT IS UNTABLE AND WHO IS AT
RISK FOR FALLS IS CONE
FORWEARABLES AND THEN YOU CAN
BRING THE PATIENT IN FOR
ADDITIONAL, VALUATION AND
EXERCISE AND SO FORTH TO TRY AND
PREVENT THE FALL.
SO IF WE CAN GET A BIOSIGNATTURE
ON OUR PATIENTS WITH PAIN, THAT
WILL ONLY HELP DIRECT SOME
CLINICAL DECISION MAKING, I
THINK THE OTHER VALUE HERE IS
THE POTENTIAL OR OPPORTUNITY TO
REINFORCE CERTAIN BEHAVIORS AND
PERHAPS EXTINGUISH RECOLLECTS
THAT ARE LESS HELPFUL FOR THE
PATIENTS ABILITY TO FUNCTION SO
PROVIDING FEETD BACK ABOUT
CERTAIN MOVEMENTS FOR EXAMPLE
WILL BE A GREAT WAY TO LEVERAGE
THIS TECHNOLOGY AND HELP
CLINICIANS AND BETTER HELP
PATIENTS.
>>SO COLLECTING DATA THAT IS
CLINICALLY MEANINGFUL THAT WILL
DIRECT INTERVENTION SELECTION
AND GID TREATMENT BUT ALSO
THAT'S DATA THAT IS OF VALUE TO
THE PATIENT FOR WHATEVER GOALS
HE HAS SET FOR HIS TREATMENT AND
HIS GOALS.
IT ISN'T--THE GOALS ARE OFTEN
ABOUT INCREASING FUNCTION,
THEY'RE NOT FSESLY ABOUT
DECREASING PAIN INITIALLY AND BY
MOVING MORE, YES, WE DECREASE
PAIN, SO BUT IT HAS TO BE A
VALUE, SEEN AS A VALUE TO THE
PATIENT BECAUSE IF THE CLINICIAN
DOESN'T SEE IT AS VALUABLE THEN
THE PATIENT WILL NOT DAWN THE
WEARABLE, THEY WILL NOT TAKE IT
HOME, THEY WILL TAKE IT HOME BUT
WILL NEVER PUT IT ON.
SO THOSE ARE SOME OF THE
REALITIES OF HAVING DONE SOME OF
THIS WORK.
>>OKAY, GREAT, I THANK YOU FOR
THAT.
I THINK THE PROGRAM LEAD IS
LISTENING IN.
>>TERRY'S HAND IS RAISED.
>>TERRY?
>>YES, I THINK THAT THIS
PARTICULAR KIND OF DATA BECAUSE
IT'S SO NOVEL AND BECAUSE
THERE'S SO MUCH INFORMATION
EMBEDDED IN IT, IT'S REALLY
IMPORTANT TO THINK ABOUT HOW TO
PRESERVE THE RAW DATA SETS WITH
THE KIND OF METADATA THAT WOULD
ALLOW PEOPLE TO CONTINUE TO TAKE
ADVANTAGE OF IT THROUGH A SORT
OF DATA SHARING MECHANISM
BECAUSE, YOU KNOW THE
COMMENTMACHINE LEARNING
ALGORITHMS THAT ARE ASTUTE BUT
THEY'RE DEVELOPING RAPIDLY AND
SO HAVING THESE VERY IMPORTANT
RAW DATA SETS WITH ALL OF
THE--INSTEAD OF A VERY REDUCED
VERSION OF THEM, I THINK IN THE
FUTURE COULD REALLY BE IMPORTANT
BECAUSE THE PEOPLE WILL BRING
THEIR NEW METHODS AND WAYS OF
INTERROGATING THESE DATA SETS TO
PROBE MANY DIFFERENT QUESTIONS
IN THE FUTURE.
SO I THINK, YOU KNOW HOPEFULLY
THERE WILL BE AN OPPORTUNITY TO
ARCHIVE THESE DATA SETS, TO HAVE
THE KIND OF METADATA ASSOCIATED
WITH THEM THAT WOULD MAKE THEM
USEFUL OVER THE LONG HALL AND
THEN TO HAVE DATA SHARING
MECHANISM SO YOU COULD INVITE
TEAMS INCLUDING DATA SCIENTISTS
BHO HAVE NOVEL METHODS TO USE TO
TRY TO FIND, DISCOVER THINGS AND
I JUST THINK THIS IS A
REAL--SHOULD BE A VERY IMPORTANT
PRIORITY.
>>THANKS, TERRY, JENNIFER HAS
HER HAND UP AS WELL.
>>YES, I'M ALSO THINK BEING TE
POTENTIAL TO COLLECT BIOMARKERS
LIKE CYTOKINES OR CORTISOL,
PERHAPS IN AN ORAL BIOSENSOR SO
SUBJECTIVE DATA RELATED TO PAIN
OR OTHER THINGS THAT MAY BE
PICKED UP IN A WEARABLE THAT'S
ON YOUR ARM OR SOMETHING, BUT
IT'S ANOTHER WAY TO COLLECT
INFORMATION THAT WE KNOW IS
OCCURRING WHEN PEOPLE ARE IN
PAIN, THAT WILL PROVIDE
ADDITIONAL OBJECTATIVITY AND IT
CAN BE LIKE AN ORTHODONTIC TOOTH
BRACKET OR SOMETHING LIKE THAT.
>>YEAH IS THAT'S DEFINITELY
WITHIN THE SCOPE OF WHAT THEY'RE
LOOKING FOR IN THE PROGRAM, SO
THEY'RE LOOKING FOR
PHYSIOLOGICAL DATA TO CREATE THE
BIOSIGNATTURE, BUT, YOU KNOW THE
DENTAL PAIN BRINGS UP A LOT OF
QUESTIONS ABOUT WHAT COULD BE
USED IN THOSE SITUATIONS AS
WELL, SO, AGAIN, WE'LL MAKE SURE
THAT GETS PASSED ON TO THE
DEVELOPMENT TEAM BUT.
>>YEAH, BUT LINDA I WILL SHARE
VERY BRIEFLY BEYOND DENTAL PAIN,
IF YOU ARE HAVING PAIN ANY
PLACE, IT'S LIKELY THAT YOUR
STRESS RESPONSE WILL BE RECORDED
IN YOUR SALIVA TERMS OF
BIOMARKERS AND THINGS.
>>YEAH, THANK YOU.
>>OKAY, WELL WE HAVE ABOUT 15
MINUTES LEFT AND WE WANT TO
PRESERVE TIME FOR FINAL
DISCUSSION, SO LET'S KEEP MOVING
TO THE SLEEP CONCEPT.
CAN WE ADVANCE MAYBE 2 OR 3
SLIDES.
THOUGHTS AND REACTIONS TO SLEEP
AND CIRCADIAN RHYTHMS FOR
TARGETING ACUTE AND CHRONIC
PAIN.
>>CHRIS?
>>I WILL JUST SAY LIKE THE
OTHER PROGRAMS, I'M ENORMOUSLY
SUPPORTIVE OF THIS 1, SLEEP HAS
BEEN 1, I'M STILL AMAZED, THAT A
LARGE PERCENTAGE OF PAIN STUDIES
REPORT ON SLEEP OR STUDY SLEEP
BUT THERE'S STILL A GOOD
PERCENTAGE OF THEM THAT DON'T
AND EVEN THOUGH, YOU KNOW THE
EVIDENCE SUGGESTS THAT THIS IS A
HUGE BI-DIRECTIONAL INFLUENCE ON
PAIN AND TRAJECTORIES FOR PAIN,
MY ONLY COMMENT ON THIS WOULD BE
TO AND I'M SURE THIS IS ALREADY
BEING DISCUSSED BUT USING SOME
SORT OF OUR SUGGESTING SOME SORT
OF CORE DOMAIN MEASURES THAT WE
ALSO KNOW DON'T INTERACT WITH
SLEEP LIKE COGNITIVE, SPEAKING
OF COGNITIVE DYSFUNCTION, I
CAN'T SAY THE WORD.
COGNITIVE DYSFUNCTION, PHYSICAL
DISABILITY, SOCIAL ACTIVITIES,
SO ON AND SO FORTH.
SO JUST A THOUGHT TO THINK ABOUT
HOW WE CAN REALLY MAXIMIZE
STUDIES COMING OUT OF THIS, NOT
JUST TO LOOK AT SLEEP AND PAIN
BUT ALSO THE OTHER DOMAINS THAT
WE KNOW INTERACT IN AND ARE
AFFECTED BY SLEEP.
>>THANK YOU.
GOOD SUGGESTIONS.
>>BOB?
>>I THINK YOU'RE MUTED.
>>SORRY ABOUT THAT.
JUST AGREEING WITH WHAT CHRIS
JUST SAID, THAT WAS OVERLA
LAPPING WITH WHAT I WAS GOING TO
SAY BUT THIS IS SOMETHING THAT
REALLY SORT OF OBVIOUSLY VERY
IMPORTANT BUT ALSO RIPE FOR
STUDY, YOU KNOW I THINK THERE'S
A VERY SUBSTANTIAL INTERFACE FOR
THE PAIN RESEARCH COMMUNITY
NECESSARILY BUT ENCOURAGING
THESE APPLICATIONS TO INVOLVE,
YOU KNOW BONA FIDE SLEEP
RESEARCHERS IN THIS CONTEXT, I
THINK WOULD BE REALLY IMPORTANT
TO KNOW OF, I DON'T KNOW IF IT'S
FACTORED IN AS FAR AS TEAM
SCIENCE BUT THERE'S SPECIALIZED
METHODOLOGY AND DETAILS THAT ARE
REQUIRED IN THE SLEEP STUDIES
THAT WILL BE BETTER BUT THERE
ARE PLENTY OF PLACES THAT HAVE
PEOPLE WHO HAVE EXPERTISE IN
CIRCADIAN BIOLOGY AND SLEEP THAT
ARE NOT DRESSING THIS THAT
EVERYBODY KNOWS THAT SLEEP AND
HEAL IS A CRITICAL COMPONENT AND
CAN BE A MODIFIABLE RISK FACTOR
POTENTIALLY.
THANK YOU.
>>SO I THINK LINDA, IS THERE 1
MORE?
>>THERE'S THE LAST PAIN ISSUE
AND THERE WERE QUESTIONS FOR
DISCUSSION SUGGESTED AS WELL IF
WE COULD SKIP DOWN TO THEM OR IF
PEOPLE HAVE QUESTIONS READY,
ROB, I THINK YOUR HAND IS STILL
UP BUT IT'S FROM BEFORE, I
THINK.
SO ALAN?
>>MY ONLY COMMENT TO THAT IS
SOMETHING IT'S AGAIN SORT OF
RELEVANT WHAT I SAID BEFORE, SO
I'VE BEEN TALKING TO THE
ORTHOPEOPLE REEBTLY, AND I
ACTUALLY HAVE TO THANK HELENE,
BECAUSE SHE TURNED ME ON TO MUSK
LA SKELETAL PAIN AND IT WAS SO
INTERESTING TO TALK TO THEM
BECAUSE AND ESPECIALLY TO THE
Ph.D.s, NOT NECESSARILY THE
SURGEONS AND CO INSURE MARKET
DENTALLY MY WIFE JUST HAD A
TOTAL KNEE REPLACEMENT SO IT'S
KIND OF STRUCK HOME.
LOTS OF PAIN BUT THEY DON'T
STUDY PAIN.
THEY STUDY BONE, THEY STUDY BONE
DEVELOPMENT, BONE ARCHITECTURE,
STRUCTURE, IT'S REALLY QUITE
INTERESTING AND THEY'RE NOT EVEN
THINKING OR I GUESS IT'S JUST
THEIR TRAINING TO LOOK AT HOW
DOES THE BONE MILIEU EFFECT THE
NERVE THAT'S INNERIVATING IT AND
SO I JUST THINK THAT SOMEHOW
THIS PARTICULAR EFFORT NEEDS TO
REACH OUT TO THEM SOMEHOW,
THEY'RE LIVING IN ANOTHER WORLD.
AND YET THEY'RE DEALING WITH
MORE PAIN THAN PROBABLY ANYBODY.
>>I DON'T THINK WE HAVE ANYBODY
ON THE CALL HERE FROM THE REJOIN
PROGRAM, DO WE?
>>I CAN SPEAK TO THAT.
IS LINDE ON?
MAYBE SHE DROPPED OFF BUT--
>>NO, I WAS--
>>GO AHEAD, LINDSAY.
>>I WAS JUST GOING TO SAY, FROM
MY FIRST ORTHOPEDICS MEETING,
THE ORTHOPEDIC RESEARCH SOCIETY
MEETING THAT'S PORT OF OUR
PORTFOLIO AND THEY'RE ABSOLUTELY
INTERESTED IN UNDERSTANDING PAIN
MECHANISMS AND TRYING TO MAKE
PROGRESS IN THIS FIELD AND IN
FACT, I TALKED ABOUT THE HEAL,
AND I TALKED ABOUT REJOIN TO
THIS COMMUNITY SO I THINK
THERE'S TREMENDOUS OPPORTUNITY
THERE AND INTEREST AND
ABSOLUTELY SOMETHING THAT HAS
BEEN OVERLOOKED TO A GREAT
EXTENT.
FOR MANY, MANY YEARS AND SO
THANK FIST ARE THAT COMMENT
ALLAN, AND HELENE, THANK YOU FOR
INTRODUCING MUSK LO SKELETAL
PAIN TO ALLAN AS AN IMPORTANT
AREA OF FOCUS.
>>NO, SHE DOESN'T INTRODUCE ME,
I EXPERIENCE IT.
[LAUGHTER]
>>WELL, WE ALL DO.
, RIGHT.
>>BUT I CAN ECHO, I THINK
LINDSAY SAID, THE ORTHOCOMMUNITY
IS COMING AROUND TO THIS BUT
YOU'RE RIGHT, ALAN THIS IS
SOMETHING THAT HAS LAGGED BEHIND
BUT I'M GLAD TOO HEAR, LOOKING
AT ABSTRACTS AND PRESENTATIONS
AT THE MEETING THAT LINDSAY'S
AT, IT LOOKS PROMISE THAT THE
SHIP IS SLOWLY TURNING.
>>SO NOW WE NEED TO GET THEM TO
REALIZE THAT MUSCLES ARE
ATTACHED TO THE BONE AND.
>>AND THEY'RE THE 2 NBUT THAT'S
RIGHT THERE WITH THE MUSCLE.
>>RIGHT.
>>BUT BY THE WAY, A HUGE
IMPEDIMENT, THIS HAS BEEN
CAPTURED IN THE CHAT, TOO IS THE
SALARY ISSUES.
SO IF DEPARTMENT CHAIRS AREN'T
COMMITTED TO RESEARCH, THERE'S A
HUGE DISINCENTIVE TO ALLOW
ORTHOPEDIC SURGEONS AND
CLINICIANS TO GET TRAINED IN
THIS AREA AND TO DEVOTE TIME TO
RESEARCH SO THAT'S A HUGE
OBSTACLE TO THAT FIELD OF COURSE
LIKE MANY OTHERS.
>>--AT THE BEGINNING AND
TEACHING WHEN THE MEDICAL
STUDENTS AND ANATOMY.
THEY COMPLETELY DISREGARD AND
PLOA RIGHT THROUGH THE FASCIA
AND DON'T PAY ATTENTION IT, GET
RID OF THIS GET RID OF THIS AND
LET'S DOWN TO MUSCLES AND
NERVES.
>>OOH.
>>YOU'RE HURTING ALLAN'S HEART.
>>IT'S TRUE THOUGH, IT'S TRUE.
IT'S SAD BUT IT'S TRUE.
I THINK WE JUDGE UOF THE HAVE TO
OWN IT.
>>SO THE MY O FACIAL UNIT
CONTINUES TO BE NEGLECTED AND
THIS REISSUING OF THIS IS
CRITICAL TO BEGIN AT LEAST
DISCOVERING SOME OF THESE
THINGS, LOOKING AT ACUTE VERSUS
LATENT PHASES AND WHAT IS
CHANGING IN THE MY O FACIAL UNIT
DEVELOPING THE TECHNOLOGIES THAT
WILL HELP US MEASURE THEM THAT
HOPEFULLY WILL BECOME CLINICALLY
USEFUL AT SOME POINT IN TIME,
THIS IS VERY MUCH INFANCY AND
VERY MUCH LONG OVERDUE.
>>AND WE CALL IT REJOINT?
>>REJOINT?
>>SO THIS A RECENTLY AWARDED
PROGRAM ALLAN THAT YOU WOULD
HAVE SEEN I SUPPOSE AT THIS .1
AND HALF TO 2 YEARS AGO.
MAYBE SOMEONE ON THE TEAM CAN
PUT INFORMATION INTO THE CHAT
AROUND WHAT WE'VE DONE.
PUBLICIZED ABOUT IT BUT REALLY
PSYCHING TO UNDERSTAND
INNERVATION OF THE JOINTS AND
HOW THESE DIFFERENT PARTS OF THE
BODY CONNECTION.
>>SORRY TO INTERRUPT, 1 THINK
THIS I DID LEARN AND IT WILL
COME UP LATER IN MODELS, 1 THING
THEY DID TELL ME IS THEY HADE
THE MIA MODEL WHICH IS THE 1
THAT IS PREDOMINANTLY USED TO
STUDY O. A. AS A MODEL OF O. A.
AND THEY JUST UNIFORMLY SAY,
IT'S NOT.
THEY PREFER THE MUNICIPAL
MODELS,IME SURE HELENE AND
LINDSAY HAVE A PERSPECTIVE ON
THAT BUT THAT WAS NEWS TO ME
BECAUSE WE WERE READY TO SET UP
THE MIA MODEL.
>>WELL, I'M GOING TO ASK
LINDSAY AND HELENE HAVE THOUGHTS
ON THAT PARTICULAR MODEL THAT WE
PUT INTO THE CHAT BUT TURNING TO
KIND OF OUR LAST 5 MINUTES OF
THIS DISCUSSION, WE HEARD A LOT
TODAY ABOUT NEW RESEARCH
PROGRAMS THAT THE TEAMS HAVE,
AND YOU HEARD OF PRECLINICAL
SIDE ABOUT THEM LOOKING AT
PERSONNEL FACTORS AND CONDITIONS
AS CONTRIBUTORS CHRONIC
OVERLAPPING PAIN CONDITIONS AS
WELL AS EXPOSURE, ELEMENTS, TO
EXPOSOME AS FACTORS IN CHRONIC
PAIN AND THEN ON THE MORE
CLINICAL SIDE WE DISCUSSED BOTH
TREATING PAIN AND PEDIATRIC
POPULATIONS AND ALSO STUDYING
CHRONIC PAIN AMONG CHILDREN IN
ADOLESCENTS.
WE TALKED ABOUT WEARABLE
BIOSENSORS.
WE TALKED ABOUT CIRCADIAN
RHYTHMS AND SLEEP, WE TALKED
ABOUT TRAINING SPECIFICALLY AND
FINDING WAYS TO PROVIDE PAIN,
TRAINING FOR CLINICIANS OF
DIFFERENT STRIPES AND HOW
FEASIBLE THAT COULD BE, HOW TO
EXPAND IT TO BE MOST MEANINGFUL
AND THEN WE TALKED ABOUT MODELS
OF MY O FACIAL PAIN AND
BIOMARKERS SO I WOULD LIKE TO
JUST ASK THIS GROUP IN OUR FINAL
MOMENTS TO WEIGH IN WITH
YOUR--WHAT ARE YOU MOST
ENTHUSIASTIC ABOUT?
WE DIDN'T GET INTO INTO BUNLET
BUT IF HEAL SCOOBT SUPPORT ALL
OF THESE CONCEPTS WHAT WOULD YOU
WISH TO SEE INCLUDED, AND WE
NEED TO FOCUS ON WHAT THE MOST
INTENSITY?
>>WOW.
>>HOW'S THAT FOR AN OPEN ENDED
QUESTION.
>>I VOTE FOR TRAINING IN THE
WORKFORCE BECAUSE WE NEED TO
RESEARCHERS AND THEN IT TERMS OF
AREAS OF FOCUSED ONECUS, I THINK
THE VERY FIRST TOPICS PRESENTED
MAY BE GOT ME THE MOST EXCITED
OF ALL THE THINGS WE PRESENTED,
I SAY THAT AT THE RISK OF
PISSING SOMEBODY OFF.
>>APPRECIATE IT.
>>IF WE'RE HAVING TO LOCK AT
THINGS TO PRIORITIZE THE
INITIAL, THE FIRST TOPIC I THINK
WHILE YOU'RE TALKING ABOUT IS
THE INDIVIDUAL DIFFERENCES IN
PAIN AND CO-MORBIDITIES, IS THAT
THE--YEAH.
AND THEN WE TALKED ABOUT THE
RELATEDNESS OF THE EXPOSOME
STUDY.
I THINK THERE ARE A BUNCH OF US
WHO HAVE QUESTIONS ABOUT THE
STATE OF RAREADINESS OF THAT AND
I'M NOT AN EXPERT IN THAT SO I'M
NOT TRYING TO LIGHT IT ON FIRE
OR ANYTHING, BUT 1 OF THE THINGS
THAT WE ALSO TALKED ABOUT, THAT
I WOULD BE MORE INTERESTED IN
THOSE TYPES OF RESOURCES BEING
DEPLOYED TO IS, YOU KNOW THE ALL
OF US STUDY, WE TALKED ABOUT THE
DIRGT OF PAIN MEASURES THERE, IS
THERE A WAY FOR HEAL TO DEPLOY
SOME RESOURCES TO GET BETTER
GRANULARITY OF DATA ON PAIN
GOING FORWARD IN THE ALL OF US
BECAUSE I FEEL LIKE THAT TYPE OF
INFORMATION, THE SIZE AND SCOPE
OF THAT PROGRAM PROVIDES A LOT
BETTER POTENTIAL INSIGHT INTO
THINGS THAT MIGHT BE STUDIED IN
MORE DETAIL IN THE CONTEXT OF AN
EXPOSOME FUTURE STUDY.
ANYWAY, MY TWO-CENTS ON THAT.
I FEEL LIKE THAT 1 DOESN'T FEEL
READY FOR PRIME TIME TO ME.
AND THERE ARE OTHER WAYS TO
DEPLOY THE RESOURCES THAT MIGHT
GET US TOWARDS THAT GOAL
INCLUDING THE FIRST 1 ON
OVERLAPPING CO-MORBIDITIES.
>>THANKS, ROB.
>>I SEE NORA YOU HAVE YOUR HAND
RAISED, ARE THERE OTHER MEMBERS
OF THE MDWG WHO HAVE THOUGHTS ON
THIS OR WE CAN CONTINUE ON IT
TOMORROW, OR YOU CAN GERMINATE
OVER THE NEXT 24 HOURS AND WE
CAN TALK AGAIN, BUT NORA I WILL
TUN IT OVER TO YOU.
>>YEAH, NO, I COMPLETELY AGREE
AND THE ALL OF US AS AN EXAMPLE
BECAUSE JOSH GREEN IS VERY
RESIPTIVE AND IN FACT IT'S
ACTUALLY SEEKING FOR
OPPORTUNITIES THAT RELATE TO
SPECIFIC DISEASE CONDITIONS
WHERE THE ALL OF US CAN PROVIDE
INFORMATION SO WE'RE DISCUSSING
IT HERE IN TERMS OF EXAMPLES IT
CAN MAKE A PERSON MORE
VULNERABLE TO DEVELOPING PAIN
CONDITIONS OR SOMEONE HA IS AN
OPIOID THAT BASICALLY BECOMES
ADDICTED SO THERE IS AN
OPPORTUNITY OF ADDRESSING
QUESTIONS THAT ARE
EXTRAORDINARILY RELEVANT
INCLUDING THE 1 OF PEDIATRIC AND
WHILE INITIALLY THE ALL OF US
DID NOT START WITH THE GROUP IN
CHILDREN, THAT'S NOT NOW
DECADES, SO, THIS IS--THAT
WAS--WHY STUDIES LIKE THIS ARE
BEING DONE AND THEY'RE EXTREMELY
EXPENSIVE BUT IF YOU LOOK AT, IF
YOU USE THEM PROPERTILY, YOU CAN
GENERATE THE MASSIVE AMOUNT OF
INFORMATION SO PERHAPS I THINK
THAT OUR THOUGHTS ON ALL OF
THIS, INCLUDING THE FACT THAT
THEY ARE OBTAINING FOR EXAMPLE,
MEASURES THAT ENABLED YOU TO
LOOK AT SLEEP PATTERNS AND
ARCHITECTURE AND MOTOR ACTIVITY,
ALL OF THEM RELEVANT TO
BIOSENSORS FOR MANAGING PAIN AND
OUTCOMES, HOW CAN WE USE HEAL TO
ACTUALLY MOUNT OUR RESOURCES
THAT WILL ADD QUESTIONNAIRES OF
GREATER GRANULARITY OF PAIN BUT
HAPPENS OTHER METRICS AND TO
ALSO INSURE THATs CORRECT
PATIENTS POPULATIONS AND
PATIENTS GROUPS ARE BEING
ENGAGED.
SO, THAT IS WHAT I JUST WANTED
TO SAY BECAUSE THAT PROJECT IS
AN EXAMPLE THAT LINKS MULTIPLE
OF THE INITIATIVES THAT WERE
DISCUSSED TODAY, WE ALSO HAVE
THE ABCD STUDY WHERE WE'RE
FOLLOWING THE CHILDREN AS THEY
TRANSITION INTO ADULTHOOD, MANY
OF THEM APPROXIMATELY 12,000 ARE
GOING TO HAVE PAIN AND WE WILL
BE ABLE TO FIEBD OUTED WHICH 1S
ARE VULNERABLE TO ADDICTION
LATER ON OR NOT.
WE ALSO JUST RECENTLY LAWRVED
LAST YEAR THE HPC D WITH
THINKING HOW TO MESH THESE
QUESTIONS, INTO THIS PROJECTS TO
MEET, TELL BE THE EXTREMELY
VALUABLE.
>>THANKS, NORA.
>>JUST A HAVE A QUICK COMMENT
REGEK BECKA IS THAT TO ECHO WHAT
BOB SAID, NOT ONLY DO WE NEED TO
TRAIN THE RESEARCH WORKFORCE AND
THE CLINICIAN WORKFORCE, AND
DEVELOP THESE MEASURES BUT WHEN
YOU DO ACROSS THE AGE SPECTRUM
SO YOU KNOW I PUT HIGH EMPHASIS
ON THE KID PROJECT AS WELL AS
EVENNUALLY LOOKING AT THE PAIN
IN THE ELDERLY WITH COGNITIVE
IMPAIRMENT AND IF WE DON'T LOOK
DOWN TO LOOKING AT MY O FACIAL
PAIN WHICH IS THE MAJORITY OF
MUSK LO SKELETAL PAIN WHICH IS
WHAT DRIVES PEOPLE TO SEEK CARE
AND GOD US INTO THIS WHOLE
OPIOID ADDICTION ISSUE IN THE
FIRST PLACE, WE'RE NOTED GOING
TO MAKE AS MUCH IMPACT ON
PROGRESS AS WE WANT TO SO I
THINK THE MY O FACIAL PAIN
PROJECT IS IMPORTANT, TOO.
>>THANK YOU SHARON AND THEN
DIANEA?
>>I JUST WANT TO CORRECT FOR
THE RECORD THAT ALL OF US STILL
HAS NOT ENROLLED 1 CHILD, THEY
HAVE HIRED A DIRECTOR FOR
PEDIATRIC RESEARCH WHO'S CHARGED
WITH FINDING OUT WAYS TO ENROLL
CHILDREN BUT THERE ARE 0
CHILDREN IN ALL OF US.
AND WHILE I TOTALLY AGREE WITH
NORA THAT CURRENTLY FUNDED
INITIATIVES WILL PROVIDE
LONG-TERM INFORMATION ON
CHILDREN WHO MAY IN ADDITION
HAVE PAIN, THE FOCUS OF THE KIDS
PAIN PROJECT IS SOMEWHAT
DIFFERENT.
IT'S REALLY COMING IN, FROM A
PAIN FOCUS AND YOU KNOW
UNDERSTANDING THAT PAIN AND
TREATING THAT PAIN.
SO IT'S--THEY'RE NOT EXACTLY THE
SAME, THEY'RE ADDITIVE IN SOME
WAYS BUT REALLY PAIN IS SUCH AN
IMPORTANT PART OF HEAL AND
THAT'S A HUGE GAP AS I SAID, SO
FOR KIDS.
>>THANK YOU DIANEA, YEAH,
THERE'S A LOT TO CHEW ON IN
TERMS OF ALL OF US RESEARCH
PROGRAM AND HOW THEY MAKE
DECISIONS AND INCORPORATE THINGS
AND FORTUNATELY WE HAVE GOOD
COLLEAGUIAL CONNECTIONS BUT WE
CAN'T JUST TELL THEM WHAT TO DO,
THEY HAVE A WHOLE PROCESS.
SO WE ARE OVERTIME ALLAN AND I
WANT TO GIVE WALTER A CHANCE TO
SPEAK, TOO, BUT ALLAN YOUR
THOUGHTS.
>>QUICK QUESTION, AND I ASKED
IT YEARS AGO, I THINK NORA
ANSWERED IT BUT I NEED TO BE
REMINDED, IS REDUCING OPIOID USE
BY SAY A COMBINATION APPROACH
SOMETHING THAT HEAL WOULD
INDORSAL POSITION OR NOT
ENDORSE?
>>THE ANSWER IS YES, WE ENDORSE
WHAT THE EVIDENCE SHOWS.
>>FAIR ENOUGH, JUST WANT TO BE
SURE.
OKAY.
>>I WANT TO BE SURE WHEN I WAS
CLEAR, WHEN I SAY REDUCE, I MEAN
STILL USE BUT LOWER DOSES.
>>YEAH, YEAH, YEAH, ABSOLUTELY.
VERY CLEAR IN MY BRAIN, ALAN.
>>GREAT.
THANK YOU.
>>TOMORROW WE HAVE AN AGENDA
AND A SET OF CONCEPTS COMING
FROM SCIENTIFIC TEAMS FOCUSED ON
INFANTS AND CHILDREN,
THERAPEUTIC DEVELOPMENT,
PREVENTION, TREATMENT AND
IMELEMENTATION SCIENCE
APPROACHES FOR THE OPIOID USE,
ADDICTION AND OVERDOSE AND WE
ALSO HAVE SOME TIME AT THE END
FOR US TO DISCUSS ALL OF THE
DIFFERENT TOPICS IN AREAS OF
RESEARCH THAT HAVE COME UP, LAST
WEEK, TODAY AND TOMORROW AND
KIND OF LOOK AT THE BIG PICTURE
TOGETHER.
BEFORE WE END TODAY, WALTER I
WOULD LIKE TO TURN IT OVER TO
YOU FOR ANY FINAL THOUGHTS.
>>REALLY GOOD DISCUSSION, I
GUESS, IF YOU LOOK AT IT FROM
FAR OUT, THE POINT IS THAT
THERE'S SO MUCH TO DO AND YOU
HAVE TO KIND OF, YOU KNOW MAKE
YOUR STRATEGIC DISDID CISIONS ON
WHATY WILL BE MOST IMPACTFUL AND
SOME OF THAT WE HAVEN'T TALKED
ABOUT A LOT IS THE FACT THAT,
YOU KNOW HEAL CAN BE THE
[INDISCERNIBLE] AND SEED TO GROW
BUT THEN CAN GET TO A STAGE
WHERE THEY CAN ACCESS RESOURCES
AT ALL THE OTHER INSTITUTES.
SO, YOU KNOW ALL THE INSTITUTES
HERE ON THIS CALL, HAVE PAIN IN
THEIR PORTFOLIO, SO I REALLY DO
THINK, YOU KNOW AS WALLY SAID,
WE GET THE TRAINING YOU KNOW IN
PAIN RESEARCH EXPANDED, THEN,
THAT COULD HAVE A REAL
MULTIPLIER EFFECT AND WE HAVE
THE HEAL PLOJ ECTOMYOSIN BUT
EVERY TRAINEE THAT COULD BE A
HEAL PROJECT, IT COULD BE FOR A
NONHEAL PROJECT THAT THEY'RE
DOING SO I THINK THAT'S REALLY
IMPORTANT AND THEN, YOU KNOW
PICKING OUR PROBLEMS, YOU KNOW
KIND OF AS YOU CAN SEE
GRAVITATING TOWARDS MORE THE
COMPLEX ISSUES AND PAIN, THE
CO-MORBIDITIES, YOU KNOW, 1 OF
THE EXPOSURES THAT GETS YOU INTO
SITUATION WHERE YOU'RE GOING TO
DEVELOP CHRONIC PAIN, YOU KNOW
REALLY HARD PROBLEMS, BUT THEN
ON THE 1 HAND, YOU KNOW THE
SLEEP IS 1 EXAMPLE WHERE WE
THINK WE CAN REALLY HAVE
POTENTIAL TO MAKE A BIG
DIFFERENCE BY ATTACKING THE
SLEEP, PAIN INTERSECTION.
SO AGAIN, LOTS OF THINGS TO DO,
REALLY APPRECIATE YOUR HELP AND
GIVING US ADVICE ON HOW THINGS
GO INTERNALLY, AND EXTERNALLY,
IF YOU THINK THERE'S SOMETHING
ELSE THAT COULD BE REALLY
IMPORTANT AND REALLY IMPACTFUL,
PLEASE LET US KNOW, WE
DEFINITELY WANT TO HEAR FROM
OUTSIDE GROUPS IN TERMS OF WHERE
WE SHOULD BE GOING NEXT AS WELL.
>>OKAY, THAT SEEMS LIKE A GOOD
PLACE TO END.
I WOULD LIKE TO THANK OUR
PRESENTERS AND I WOULD LIKE TO
THANK THE AUTHORS OF THE
CONCEPTS YOU HEARD DISCUSSED
TODAY AND I WOULD LIKE TO THANK
YOU ALL FOR YOUR THOUGHTFUL
MEETING AND FEEDBACK TO THIS
MEETING FOR GIVING YOUR TIME TO
HEAL.
WE WILL CONVENE TOMORROW AT 11
AM EASTERN TIME, UNTIL THEN
THANK YOU VERY MUCH.