>> WELCOME, EVERYONE.
I SEE MEMBERS OF THE HEAL
EXECUTIVE COMMITTEE AND MEMBERS
OF THE HEAL MULTI-DISCIPLINARY
WORKING GROUP JOINING.
THANK YOU, ESPECIALLY FROM THE
WEST COAST, IT'S A LITTLE BIT
EARLY.
PARISA, ARE YOU ABLE TO TAKE US
THROUGH ROLL.
>> I'M HERE.
HOPEFULLY YOU CAN HEAR ME.
DR. TABAK IS HERE.
LET'S SEE.
WE HAVE DR. CRISWELL, DR.
WEBSTER, DR. LANGEVIN, I SEE
VOLKOW.
>> DR. NUSSBAUM.
>> CAN WE HAVE THE MEMBERS SAY
GOOD MORNING AND MAKE SURE THEIR
AUDIO WORKS?
>> IT WORKS, I'M HERE.
>> THANK YOU.
>> KEEP GOING.
>> DR. DONOFRIO?
>> HERE.
>> DR. DEBAR?
>> HERE, THANKS.
>> DR. GARLAND?
>> I'M HERE, GOOD TO SEE
EVERYONE.
>> DR. JARREAU.
>> GOOD MORNING, EVERYONE.
>> DR. JERNIGAN.
>> HI, I'M HERE, GOOD MORNING.
>> DR. HENRY?
>> GOOD MORNING.
>> PERFECT.
DR. KUNTZ?
NOT ON YET, OKAY.
DR. NUÑEZ?
OKAY.
DR. PACE?
>> HERE, GOOD MORNING.
>> GOOD MORNING.
DR. SMITH?
>> HI.
>> HELLO.
AND CHRIS BEASLEY.
>> -- CHRIS
VEASLEY.
>> GOOD MORNING.
>> FROM NIH I SEE DR. GORDON
ALSO JOINED.
LET'S SEE HERE.
OKAY.
DR. KOROSHETZ IS HERE.
HELLO.
>> HEY.
>> THAT'S PRETTY GOOD.
THANK YOU.
I WILL EXTEND A WELCOME TO THE
MEMBERS OF THE HEAL EXECUTIVE
COMMITTEE AND MEMBERS OF THE
HEAL MULTI-DISCIPLINARY WORKING
GROUP.
THANK YOU FOR JOINING US AT THE
END OF MAY FOR A BRIEF OPEN
SESSION AND UPDATES AND
INFORMATION ABOUT PROGRESS OF
"HEAL" RESEARCH UNDERWAY.
AND THEN WE'LL SWITCH TO CLOSED
SESSION, WHERE WE WILL DISCUSS
SOME HEAL RESEARCH PROJECTS
UNDER CONSIDERATION.
I'LL NOW TURN IT OVER TO DR.
LAWRENCE TABAK, ACTING DIRECTOR
OF THE NATIONAL NATIONAL INSTIF
HEALTH, TO START US OFF.
GO AHEAD, LARRY.
>> THANKS, REBECCA.
I APPRECIATE YOUR LEADERSHIP OF
THIS RATHER LARGE AND COMPLEX
ENDEAVOR, AND I REALLY WANT TO
THANK YOUR TEAM AS WELL FOR ALL
THAT THEY ARE DOING.
WELCOME TO ALL THE MEMBERS OF
THE GROUP.
I THINK, YOU KNOW, IT'S NOT
HYPERBOLE TO SAY THAT "HEAL"
RESEARCH IS PROVIDING HOPE TO
MILLIONS OF PEOPLE.
AND WHAT WE DO WITH THIS WORKING
GROUP IS WE SEEK A REALITY CHECK
ON WHAT IT IS THAT WE'RE DOING.
THIS GROUP IS ONE OF SEVERAL
WHICH HELPS ENSURE THAT WHAT
WE'RE DOING IS RELEVANT AND
ALIGNED WITH THE STATE OF THE
SCIENCE.
PUBLIC HEALTH CHALLENGE, YOU ALL
KNOW ALL TOO WELL, REMAINS
URGENT.
WE NEED TO BE STRATEGIC ABOUT
OUR RESEARCH PROGRAMS.
AND WE NEED TO GET RESULTS OUT
TO SCIENTISTS AND COMMUNITIES AS
QUICKLY AS POSSIBLE.
I'M VERY PLEASED "HEAL"
CONTINUES TO PUSH FORWARD
NIH-WIDE EFFORTS FOR MORE OPEN
SCIENCE, AND FOR MORE RAPID
DISSEMINATION OF FINDINGS, AND
ALL OF YOU CAN HELP US AMPLIFY
THESE EFFORTS, AND WE THANK YOU
FOR YOUR WILLINGNESS TO DO SO.
NOW, AGAIN, I NEED NOT TELL THIS
GROUP CHRONIC PAIN REMAINS AN
ENORMOUS PUBLIC HEALTH
CHALLENGE.
AND WE KNOW CERTAINLY THAT
CHRONIC PAIN IS JUST NOT A
LONGER-LASTING VERSION OF ACUTE
PAIN.
I THINK WHAT EMERGES IS THAT
WHEN YOU'VE SEEN A PATIENT IN
CHRONIC PAIN, YOU'VE SEEN A
PATIENT IN CHRONIC PAIN.
AND THAT SORT OF GENERIC
APPROACH WON'T NECESSARILY WORK.
AND SO THE WHOLE-PERSON APPROACH
THAT "HEAL" HAS EMBARKED ON DOES
SEEM TO BE IN SYNCHRONY WITH
WHAT WE THINK IS A NEED TO
DEVELOP PERSONALIZED TREATMENT
PLANS FOR PAIN.
JUST A FEW WEEKS AGO, THE
NATIONAL CENTER FOR
COMPLEMENTARY AND INTEGRATIVE
HEALTH PUBLISHED A PAPER ABOUT
CHRONIC PAIN IN THE U.S.
THE STUDY ANALYZED NATIONAL
HEALTH INTERVIEW SURVEY DATA AND
FOUND THAT CHRONIC PAIN IS MORE
COMMON THAN EITHER DEPRESSION OR
DIABETES.
AND THAT I THINK REPRESENTS A
CLEAR CALL TO ACTION FOR THE
IMPORTANT WORK THAT WE'RE ALL
DOING TOGETHER TO CONTINUE.
UNTREATED PAIN CONTINUES TO BE A
TROUBLESOME DRIVER OF OPIOID
USE, AND ITS OBVIOUS
CONSEQUENCES BUT WE'RE MAKING
SOME HEADWAY.
SO TODAY YOU'LL HEAR ABOUT PAIN
MANAGEMENT RESEARCH THAT
INCLUDES THE CONTINUING SEARCH
FOR NEW DRUG PAIN -- NEW PAIN
TARGETS, DEVELOPING BETTER PAIN
MODEL SYSTEMS, AND TESTING
DRUG-FREE PAIN MANAGEMENT
STRATEGIES.
"HEAL" HAS REALLY OPENED UP LOTS
OF THINGS TO ADDRESS THIS MAJOR
HEALTH PROBLEM, HURDLES ARE
MANY.
FOR EXAMPLE, INCLUDING FIGURING
OUT HOW TO INCREASE ACCESS TO
TREATMENTS THAT WORK, HOW TO PAY
FOR THEM, HOW TO BE FAIR AND
EQUITABLE.
BUT "HEAL" IS ALSO WELL
POSITIONED TO ADDRESS THESE
CHALLENGES AS WELL AT MYRIAD OF
WORKFORCE-RELATED ISSUES.
"HEAL" HAS RECENTLY STOOD UP
SEVERAL TRAINING PROGRAMS FOR
INNOVATEIVE RESEARCH FOR
ADDICTION AND PAIN.
ONE IS THE SO-CALLED PURPOSE
NETWORK, WHICH IS A BRAND-NEW
NATIONAL PAIN RESEARCH NETWORK,
BY CONNECTING PAIN SCIENTISTS
FROM ALL DISCIPLINES AT VARIOUS
CAREER STAGES, "HEAL" IS FILLING
A MAJOR GAP BY DEVELOPING AND
NURTURING A COMMUNITY OF
PRACTICE AND MUTUAL LEARNING.
AND JUST LAST WEEK A STUDY
FUNDED BY THE NIH BRAIN
INITIATIVE, HEAL, AND DARPA
REPORTED ON BRAIN SIGNATURES FOR
CHRONIC PAIN AND A SMALL NUMBER
OF FOLKS USING SURGICALLY
IMPLANTED ELECTRODES, TARGETING
THEIR ANTERIOR CINGULATE CORTEX
AND ORBITAL FRONTAL CORTEX, AS
THE PARTICIPANTS ACTUALLY
REPORTED ON CURRENT LEVELS OF
PAIN.
IT REALLY OPENS YOU WILL A WHOE
NEW SET OF THINGS THAT CAN BE
DONE IN THE FUTURE.
THE FEDERAL RESPONSE, BECAUSE
"HEAL" IS AN NIH-WIDE INITIATIVE
DOES BENEFIT FROM A LARGE AND
DIVERSE RESEARCH PORTFOLIO THAT
IS SUPPORTED BY MANY OF THE NIH
INSTITUTES AND CENTERS.
AS YOU KNOW, NIH WORKS VERY
CLOSELY WITH OUR FEDERAL
PARTNERS, INCLUDING THE CDC,
FDA, SAMHSA, DEA, AND OTHERS.
SCIENTIFIC SOLUTIONS ARE REALLY
IMPORTANT TO INFORM UNMET
MEDICAL NEEDS, BUT CLEARLY LAWS
AND POLICY INFORMED BY SCIENCE
ARE ALSO CRITICAL.
WE MEET MONTHLY WITH OUR FEDERAL
PARTNERS AND OUR WORK TOGETHER
WE FEEL IS HAVING AN IMPORTANT
IMPACT ON THE NATIONAL LANDSCAPE
ON WHICH HEAL RESEARCH IS
CONDUCTED.
AS YOU'VE HEARD IN MARCH, THE
FDA APPROVED OVER THE COUNTER
NALOXONE, AN IMPORTANT STEP
GUIDED BY A PRODUCTER FEDERAL
RESPONSE INCLUDING OUTREACH TO
STATES THROUGH SAMHSA, AND WORK
IS UNDERWAY TO FIGURE OUT HOW TO
INCREASE ACCESS TO THIS
LIFE-SAVING MEDICATION.
UNFORTUNATELY COST REMAINS A
BARRIER.
AND SOME RESEARCHERS ARE USING
THESE INNOVATIVE APPROACHES
TAKING ADVANTAGE OF A.I. AND
SOCIAL MEDIA TO SEE IF THEY CAN
FIGURE OUT BETTER WAYS TO TRACK
OVERDOSE AND DRUG USE PATTERNS
SO THEY CAN MAP THE PLACE WHERE
HELP IS MOST NEEDED.
NOW, IN ADDITION, JUST LAST WEEK
FDA APPROVED TWO NEW MEDICATIONS
TO HELP PEOPLE KEEP SAFE AND
FIND LONG-TERM RECOVERY.
ONE IS A NALOXONE ALTERNATIVE, A
NASAL SPRAY VERSION OF NALOPHANE
THAT CAN QUICKLY RESUSCITATE
USERS AND PROTECT FROM RELAPSE,
USED FOR DECADES TO REVERSE
OVERDOSES OF HEROIN, FENTANYL,
AND PRESCRIPTION PAIN KILLERS,
AND THIS UNLIKE NALOXONE ENTERS
THE BRAIN VERY QUICKLY AND
REMAINS LONGER IN THE BODY.
THE SECOND APPROVAL PROVIDES A
NEW BUPRENORPHINE DOSING OPTION,
SPECIFICALLY THE FDA APPROVED
THE EXTENDED RELEASE
BUPRENORPHINE INJECTION TO TREAT
MINOR TO SEVERE OPIOID USE
DISORDER, AVAILABLE IN DIFFERENT
FORMULATIONS THAT COULD BE
ADMINISTERED WEEKLY OR MONTHLY,
REFLECTING A REAL AND MEANINGFUL
COLLABORATION ONGOING BETWEEN
THE NIH AND THE FDA.
BUT OBVIOUSLY WE CAN'T JUST REST
ON THESE RECENT SUCCESSES.
THERE ARE MANY NEW THREATS LIKE
XYLAZINE AND DRUG COMBINATIONS
THAT MAKE OUR ONGOING WORK
CHALLENGING AN UNPREDICTABLE.
XYLAZINE IS A MAJOR CHALLENGE
FOR PUBLIC HEALTH.
THIS NON-OPIOID ANIMAL
TRANQUILIZER, HENCE THE NICKNAME
TRANQ ON THE STREET IS MIXED
WITH OTHER DRUGS SUCH AS
FENTANYL ARE NO GOOD ANTIDOTE
FOR THIS.
IT CAN LEAD TO SERIOUS TISSUE
DAMAGE AT THE INJECTION SITE.
PREVIOUSLY XYLAZINE WAS MAINLY
USED IN A FEW CITIES ON THE EAST
COAST BUT NOW THIS DEVASTATING
DRUG HAS SPREAD RAPIDLY ACROSS
THE COUNTRY.
JUST LAST MONTH THE WHITE HOUSE
OFFICE OF NATIONAL DRUG CONTROL
POLICY DESIGNATED FENTANYL
ADULTERATED WITH XYLAZINE AS AN
EMERGING THREAT.
THE BIDEN ADMINISTRATION WILL BE
RELEASING A RESPONSE PLAN AND
IMPLEMENTATION GUIDANCE TO
ADDRESS THIS THREAT.
THE PLAN WILL INVOLVE TESTING,
EPIDEMIOLOGY, PREVENTION,
TREATMENT, AND CARE, AS WELL AS
THE NECESSARY DATA SYSTEMS AND
STRATEGIES TO ADDRESS SUPPLY
CHAIN ISSUES.
THE PLAN WILL CALL FOR
COLLABORATION ACROSS FEDERAL
AGENCIES AND WILL CALL FOR
RESEARCH, INCLUDING STUDIES TO
UNDERSTAND INTERACTION BETWEEN
FENTANYL AND XYLAZINE.
FEDERAL POLICY CERTAINLY AFFECTS
"HEAL" RESEARCH AND THE
POPULATION RESEARCH AND POLICY
SURROUNDING TELEHEALTH LOOM
LARGE.
NOW, MEMORIES OF THE PANDEMIC
LIFE ARE STILL VERY FRESH IN ALL
OF OUR MINDS, AND MANY PEOPLE
HAVE COME TO APPRECIATE THE
FLEXIBILITY OF THE VARIOUS
TELEHEALTH PLATFORMS FOR
RECEIVING CARE FROM PHYSICIANS
AND OTHER HEALTH CARE PROVIDERS
TO ACCESS MEDICATIONS AND MENTAL
HEALTH TREATMENT.
YOU MAY HAVE HEARD THAT THE DEA
IN CONCERT WITH HHS ISSUED A
TEMPORARY RULE EXTENDING ALL
THESE FLEXIBILITIES BUT
TELEHEALTH PRESCRIBING SERVICES
THROUGH NOVEMBER 11 INCLUDES
BOTH PRESCRIPTION OF METHADONE
AND BUPRENORPHINE.
DEAE AND HHS HOSTED A TOWN HALL
IN MARCH TO DISCUSS
BUPRENORPHINE AVAILABILITY WITH
PHARMACEUTICALS ORGANIZATIONS,
WHOLE WHOLESALERS.
TELEHEALTH IS A FLUID
ENVIRONMENT THAT WILL BENEFIT
FROM RESEARCH AND POLICY
PRACTICE, AND NO DOUBT WHEN THIS
GROUP MEETS AGAIN WE'LL HAVE AN
UPDATE ON THE STATUS OF
TELEHEALTH.
WHEN YOU MET IN FEBRUARY YOU
HEARD ABOUT NEW LEGISLATION THAT
AFFECTS THE CONTEXT OF "HEAL"
RESEARCH, THE MAINSTREAMING
ADDICTION TREATMENT ACT AND
MEDICATION ACCESS AND TRAINING
EXPANSION ACT PROVIDED HISTORIC
FUNDING FOR MENTAL AND
BEHAVIORAL HEALTH PROGRAMS.
THE LAWS WILL UPDATE TRAINING
REQUIREMENTS FOR CLINICAL
WORKERS, AND PUT MORE DOLLARS
INTO THE GROWING BEHAVIORAL
HEALTH WORKFORCE WHICH AS YOU
ALL KNOW IS UNDER SEVERE STRESS.
"HEAL"'S EFFORTS TO STRENGTHEN
THE PAIN WORKFORCE ARE AN
IMPORTANT ADJUNCT TO THESE NEW
LAWS.
NOW, TO CONCLUDE, THE NATIONAL
CRISIS OF UNDERTREATED PAIN
SUBSTANCE USE AND OVERDOSE IS A
SIGNIFICANT CHALLENGE, TO BE
SURE.
SEEMS THAT EVERY FEW MONTHS A
NEW WRINKLE EMERGES, COMPLICATED
AN ALREADY COMPLEX SUITE OF
HEALTH CONDITIONS, INFLUENCED BY
OF COURSE MANY SOCIETAL FACTORS.
WHAT RESEARCHERS HOPE, IT IS
IMMENSELY GRATIFYING TO SEE
MAJOR RESULTS NOW COMING
THROUGH, AND REBECCA WILL SHARE
MANY OF THESE WITH YOU SHORTLY.
THROUGH THE POWER OF SCIENCE AND
EMPOWERING COMMUNITIES, "HEAL"
IS MAKING A DIFFERENCE IN LIVES
OF INDIVIDUALS AND COMMUNITIES
ACROSS THE NATION.
I WANT TO THANK YOU AGAIN FOR
YOUR TIME, FOR YOUR TALENT, AND
YOUR DEDICATION TO THESE
PROGRAMS.
WE CERTAINLY RELY ON YOU TO HELP
ENSURE THAT WE'RE ON THE BEST
PATH FORWARD, TO ACHIEVE THE
"HEAL" MISSION OF ENDING
ADDICTION LONG TERM.
AND SO WITH THAT I THANK YOU
AND, REBECCA, I WILL TURN IT
BACK TO YOU.
>> THANK YOU SO MUCH, DR.
TABAK.
IT'S NOW MY PLEASURE TO TURN IT
OVER TO DR. WALTER KOROSHETZ,
DIRECTOR OF THE NATIONAL
INSTITUTE OF NEUROLOGICAL
DISORDERS AND STROKE.
TAKE IT AWAY, WALTER.
>> THANKS VERY MUCH, REBECCA.
THANKS VERY MUCH, LARRY.
AND, YES, I'M GOING TO TALK
ABOUT THE OVERVIEW OF THE
CLINICAL PAIN REVIEW.
NEXT SLIDE.
SO, JUST TO -- I'M NOT MUTED, AM
I?
NO, OKAY.
>> WE HEAR YOU.
>> OKAY.
YEAH, JUST TO GO BACK A SECOND,
AS WE STARTED "HEAL," THE
PURPOSE WAS TO DEVELOP
NON-ADDICTIVE TREATMENTS FOR
PAIN, AND THAT WAS DEVELOPING
NOVEL TREATMENTS BUT ALSO
TESTING THINGS THAT ARE ALREADY,
YOU KNOW, IN THE ARMAMENTARIUM
TO IMPROVE MANAGEMENT OF PAIN,
WHICH LARRY TOLD US HOW BIG A
PROBLEM IT IS, BUT ALSO TO
REDUCE ADDICTION AS A
CONSEQUENCE BECAUSE THAT'S KIND
OF HOW WE GOT INTO THE EPIDEMIC
OF OPIOID OVERUSE DISORDERS IN
THE FIRST PLACE.
SO IN THE PAIN SPACE, THE
DISCOVERY PART IS DONE PRIMARILY
BY THE INSTITUTES.
BUT THEN "HEAL" HAS PROGRAMS TO
MOVE DISCOVERY THROUGH THE
PRE-CLINICAL DEVELOPMENT SPACE,
TO DEVELOP A NOVEL THERAPY THAT
WOULD HOPEFULLY GET PICKED UP BY
INDUSTRY FOLKS AND BROUGHT TO
COMMERCIALIZATION.
NOW, UNFORTUNATELY, THAT IS A
PROBLEM BECAUSE THERE'S VERY
LITTLE INTEREST ON THE PART OF
THE INDUSTRY DUE TO PREVIOUS
FAILURES.
BUT THERE ARE BIOTECH COMPANIES
IN THIS SPACE, AND WE'RE HOPING
TO DE-RISK SOME OF THIS PROCESS
SO EVENTUALLY PATIENTS WILL SEE
MUCH MORE EFFECTIVE TREATMENTS
FOR CHRONIC PAIN THAT DON'T
CAUSE ADDICTION.
BUT IN THAT SPACE WE DO SOME
CLINICAL TRIALS, SAY EPPIC-NET
PHASE 2 STUDY OF NOVEL
THERAPIES, WE ARE DOING CLINICAL
TRIALS TO TEST DIFFERENT WAYS
MANAGING DIFFERENT TYPES OF PAIN
IN A MUCH MORE EFFECTIVE MANNER,
AND ALSO IN DOING SO REDUCING
THE RISK OF ADDICTION.
SO, IN TERMS OF THE SPACES THAT
WE'RE IN NOW, WE'RE LOOKING
HEAVILY AT CLINICAL BIOMARKERS
BECAUSE ONE THING THAT'S KEEPING
THE COMPANIES OUT OF THE PAIN
SPACE IS THAT THIS RELIANCE ON
PAIN ASSESSMENT 1-10 SCALE HOW
MUCH PAIN DO YOU HAVE, THERE
AREN'T THE KIND OF BIOLOGICAL
MARKERS THAT YOU NEED TO TEST
YOUR DRUG AGAINST A TARGET TO
KNOW IF YOU HAVE TARGET
ENGAGEMENT OR PROOF OF
PRINCIPLE.
SO WE HAVE A BIOMARKER PROGRAM,
AGAIN VERY DIFFICULT IN THE PAIN
SPACE BUT WE'RE MAKING SOME
PROGRESS.
NOW, MUSCULOSKELETAL PAIN
ESPECIALLY LOW BACK PAIN AND
NECK PAIN ARE LEADING CAUSE OF
DISABILITY IN THE U.S.
AND WE HAVE A PROGRAM BACPAC
WHICH IS RUN BY DR. CRISWELL'S
INSTITUTE, NIAMS, TRYING TO GET
AT THE UNDERLYING DIFFERENT
CAUSES OF THIS VERY TROUBLESOME
PROBLEM, AND DEVELOPING KIND OF
CUSTOMIZED TREATMENTS DEPENDING
ON WHAT IS THE NATURE OF THE
CONDITION.
AS I MENTIONED, WE HAVE THE
EPPIC-NET PROGRAM TO BRING
THINGS IN USUALLY FROM BIOTECH
COMPANIES INTO FIRST-IN-HUMAN
TRIALS, A VERY INTERESTING STUDY
IN PEOPLE ON DIALYSIS WHO SUFFER
PAIN, VERY COMMONLY, TO GET MORE
EFFECTIVE NON-ADDICTIVE
TREATMENTS.
WE HAVE A NUMBER OF
EFFECTIVENESS TRIALS, THE EARN
NETWORK TESTING DIFFERENT WAYS
OF TESTING PAINING WITH
PHARMACOLOGICAL, AND A SUITE OF
PRAGMATIC TRIALS RUN BY DR.
LANGEVIN'S GROUP PRIMARILY,
TESTING MOSTLY
NON-PHARMACOLOGICAL THERAPIES IN
HEALTH CARE SYSTEMS, WE HAVE
RESEARCH TO IMPROVE HEALTH
EQUITY IN TERMS OF TREATMENT OF
PAIN.
AND THE BIG PROBLEM IS HOW TO
MANAGE PEOPLE WHO HAVE A
COMBINATION OF PAIN AND OPIOID
OVERUSE DISORDER, OR PAIN AND
CHRONIC OPIOID USE.
AND A BIG PUSH TO TRY TO MOVE
INTO RURAL POPULATIONS WHERE THE
PAIN PROBLEM IS ACTUALLY WORSE
THAN IT IS IN URBAN AREAS, AND,
AGAIN, ACCESS TO THERAPIES IS
NOT AS GOOD.
A NUMBER OF THINGS THAT WE DO I
THINK IS GOING TO REALLY
TRANSFORM THE FUTURE OF PAIN
RESEARCH.
WE'RE DEVELOPING SYSTEMS TO
ENGAGE PATIENTS LIKE NEVER
BEFORE.
OF COURSE FOR PAIN THIS IS SO
INCREDIBLY IMPORTANT BECAUSE
IT'S THAT EXPERIENCE OF PAIN IS
WHAT WE'RE TRYING TO GET AT, AND
SUFFERING CAUSED BY THE PAIN NOT
NECESSARILY SENSATION OF PAIN
BUT THAT SUFFERING THAT GOES
ALONG WITH IT.
THE PAIN WORKFORCE IS ALSO
SOMETHING THAT WE'RE
CONCENTRATING ON, PARTICULARLY
IN THE CLINICAL SIDE.
AS CLINICIANS SPECIALIZING IN
PAIN ARE BECOMING QUITE RARE,
BUT YET THE RESEARCH THAT'S
COMING OUT OF THE DISCOVERY PAIN
SCIENCE IS REALLY QUITE
STRIKING, ADVANCED, TRYING TO
MATCH UP A CLINICAL WORKFORCE
THAT CAN TAKE ADVANTAGE OF THESE
EXPLOSIONS IN THE NEUROSCIENCE I
THINK IS WHAT WE'RE HOPING TO
DO.
AGAIN, WE'RE TRYING TO IMPROVE
THE DIVERSITY OF THE WORKFORCE
AND THROUGH ALL THIS THE IDEA IS
TO TRY AND BRING ALL THE DATA
TOGETHER SO THAT ONE CAN COMPARE
ACROSS DIFFERENT PAIN
CONDITIONS, DIFFERENT
TREATMENTS.
SO THIS IS KIND OF THE CLINICAL
PAIN PROGRAM IN TOTO AS IT
STANDS RIGHT NOW, NOT WITH ALL
THE DETAILS BUT IN BROAD
STROKES.
NEXT SLIDE.
THE NEXT SLIDE SHOWS WHERE WE
ARE IN TERMS OF TYPE OF PAIN
CONDITIONS.
IN TERMS OF LOOKING AT THE
BIOMARKERS AND THE DIFFERENT
BIOMARKER ASSAYS PEOPLE ARE
LOOKING AT IN FLUIDS,
MULTI-MODALITY BIOMARKERS, EVEN
SOME EEG BIOMARKERS, MANY OF
THEM GETTING AT PROGNOSTIC,
PARTICULARLY IN POST-SURGICAL
PAIN WHERE YOU LIKE TO KNOW WHO
IS AT RISK FOR DEVELOPING
POST-SURGICAL PAIN AND
POTENTIALLY DO SOMETHING TO
PREVENT IT.
THANKS TO HELENE LANGEVIN WE
HAVE AN AMBITIOUS PROGRAM
LOOKING AT MYOFASCIAL TISSUES
AND THE CAUSE OF PAIN THERE.
VERY UNDERSTUDIED AREA.
I HAVE EXPERIENCE IN IT
PERSONALLY, AND IT'S NOT FUN.
BUT WHAT CAUSES IT IS REALLY
QUITE A MYSTERY.
YOU KNOW, IT'S THE JOINTS,
MUSCLES, FASCIA, ASSOCIATED SOFT
TISSUES, AND REALLY GETTING AT
THIS IN A WAY THAT'S NEVER BEEN
ACCOMPLISHED BEFORE,
PARTICULARLY IN GETTING
BIOMARKERS OF THE CONDITION,
WE'RE USING THINGS LIKE
ULTRASOUND, PET,
ELECTROPHYSIOLOGY, M.R.,
MEASUREMENTS OF STIFFNESS, O2
PERFUSION, MARKERS OF FIBROSIS,
PARTICULARLY ULTRASOUND,
BRINGING INTO MULTI-SCALE
MODELING TYPE OF ENVIRONMENT IS
POTENTIALLY GOING TO BE
TRANSFORMATIVE, HOW WE THINK
ABOUT IT.
THE MOST COMMON PAIN CONDITION
IS MUSCULOSKELETAL PAIN
CONDITIONS.
NEXT SLIDE.
HELENE WILL CORRECT ME IN I MADE
MISTAKE, EPPIC-NET HAS WHO
TRIALS ONGOING, ARTHRITIS AND
DIABETIC PRIVILEGE NAIL --
PERIPHERAL NEUROPATHY, THERE'S
INTEREST ON A BUNCH OF COMPANIES
OUT THERE TO TEST THEIR
THERAPIES IN THIS DIABETIC
PERIPHERAL NEUROPATHY CONDITION.
NEXT SLIDE.
THIS IS GOING TOWARDS
EFFECTIVENESS RESEARCH NETWORK,
RUN HEAVILY OUT OF NCATS AND
JANE ATKINSON I SHOULD HAVE
MENTIONED FROM THE BEGINNING ALL
THESE PROGRAMS ARE RUN BY TEAMS,
THAT HAVE PROGRAM DIRECTORS FROM
MULTIPLE INSTITUTES ON THEM, AND
JANE ATKINSON AND LINDA PORTER
ARE KIND OF THE CHAIRS OF THOSE
TEAMS, AND THAT'S WHERE THE
PEOPLE HERE WHO ARE DOING ALL
THE WORK.
IN THE EFFECTIVENESS RESEARCH
SPACE WE HAVE LOOK -- LOOKING AT
DIFFERENT TRIALS ON A NUMBER OF
CONDITIONS, ACTUALLY ARTHRITIS,
POST-CESAREAN, POST MASTECTOMY,
CHRONIC MUSCULOSKELETAL, RURAL
AREAS, CHRONIC PAIN AND OUD,
CANCER PAIN, PERIOPERATIVE PAIN
IN ADULTS AND ADOLESCENTS, IF
YOU FACTOR IN ACUTE TO CHRONIC
PAIN PROGRAM BEING RUN OUT OF
THE COMMON FUND.
THE INTERVENTIONS ARE STEPPED UP
MEDICAL INTERVENTIONS AS MIGHT
OCCUR IN THE PRACTICE SITUATION,
SHARED DECISION MAKING AND USE
OF OPIOIDS AND REALLY CAUTIOUS
AND DELIBERATE MANNER, DRUG
INTERVENTIONS, DRUG AND
BEHAVIORAL INTERVENTIONS, AND
BEHAVIORAL INTERVENTIONS.
NEXT SLIDE.
IN THE PRAGMATIC STUDIES, AGAIN
HEAVILY RUN OUT OF NCCIH, IN
FACT HELENE LANGEVIN'S
INSTITUTE, LOOKING AT NERVE
STIMULATION, PHYSICAL THERAPY,
ACUPUNCTURE, RELAXATION,
MINDFULNESS, DECISION SUPPORT,
MOSTLY NON-PHARMACOLOGICAL
TREATMENTS IN THESE DIFFERENT
PAIN CONDITIONS AND MANY ARE RUN
IN HEALTH CARE SYSTEMS,
EFFECTIVENESS RESEARCH NETWORKS
ARE PRIMARILY IN ACADEMIC
INSTITUTIONS.
NEXT SLIDE.
HERE YOU SEE THE DIFFERENT PAIN
CONDITIONS AND NUMBER OF AWARDS
AND DIFFERENT PAIN CONDITIONS,
SO THEY ARE PRETTY MUCH ALL
CHRONIC PAIN, NOT DOING A LOT IN
THE ACUTE PAIN SPACE, BUT
BECAUSE CHRONIC PAIN AS LARRY
MENTIONED IS THE PROBLEM AT HAND
THAT GETS YOU INTO TROUBLE WITH
OPIOIDS BUT ALSO IS WHAT CAUSES
THE LONG-TERM SUFFERING.
BACK PAIN IS SEVERAL AS I
MENTIONED THE BIGGEST OF ALL.
POST-SURGICAL PAIN, CANCER PAIN,
TRAUMA PAIN, PARTICULARLY OF
INTEREST TO NIDCR IS
TEMPOROMANDIBULAR DISORDER.
AGAIN, FOCUSING SIMILARLY IN ON
WHAT WE TALKED ABOUT WITH
MYOFASCIAL PAIN, WHERE YOU HAVE
A VERY COMPLEX JOINT, YOU HAVE
MULTIPLE DIFFERENT TISSUES
INVOLVED, MUSCLE, FASCIA,
NERVED, AND IS A FOCUS OF A
NUMBER OF OUR PROGRAMS.
WE ALSO HAVE PROGRAMS IN SICKLE
CELL DISEASE, A VERY COMMON PAIN
CONDITION, AND ONE WHICH DOES
REQUIRE OPIOIDS TO TREAT THE
ACUTE STAGES.
SO, KIND OF THREADING THAT
NEEDLE OF GETTING REALLY GOOD
EFFECTIVE PAIN CONTROL, AND
REDUCING THE CHANCE OF ADDICTION
IS A REAL CHALLENGE BUT ONE
THAT'S REALLY BEEN TAKEN ON BY A
NUMBER OF PROJECTS IN THE HEAL
INITIATIVE.
NEXT SLIDE.
AND THE INTERVENTIONS, WE
MENTIONED IN THE PREVIOUS SLIDE
WHAT THE INTERVENTIONS ARE.
THE SETTINGS, YOU KNOW, MAJORITY
ARE DONE IN THE OUTPATIENT
CLINIC, CERTAINLY CHRONIC PAIN
IS PRIMARILY GOING TO BE SEEN IN
THE OUTPATIENT CENTER.
ACADEMIC MEDICAL CENTERS ARE,
YOU KNOW, THE DRIVERS OF
RESEARCH IN OUR SYSTEM HERE,
LARGELY OUTPATIENT CLINIC BASED
AND BASED OUT OF HOSPITALS,
PRIMARY CARE.
WE HAVE A PRETTY INTERESTING
COMPONENT OF TELEHEALTH,
PARTICULARLY WHEN IT GETS OUT TO
GETTING TREATMENTS IN RESEARCH
IN THE RURAL SPACE, SOME, AS
MENTIONED, PARTICULARLY PRISM
PRAGMATIC STUDIES, WE WORK WITH
THE V.A.
DR. LANGEVIN RUNS A PROGRAM IN
PAIN WITH THE DoD AND V.A.
HERE IS THE DIALYSIS CLINIC FOR
THE H.O.P.E. STUDY.
WE'RE HOPING TO DO MORE DENTAL
PAIN.
ENCOURAGED AT EVERY OPPORTUNITY
AND SHOULD BE DOING THAT.
THAT'S HOW MOST OF US RUN INTO
SERIOUS PAIN ISSUES.
NEXT SLIDE.
I STILL REMEMBER AS A KID GOING
TO THE DENTIST AND WAS NOT GOOD
FOR ME BECAUSE I AVOIDED
DENTISTS THEREAFTER.
AND NOW THE MOST VEXING PROBLEM
THEN IS BEING ATTACKED BY THESE
"HEAL" TRIALS INTEGRATED
MANAGEMENT OF CHRONIC PAIN
OPIOID OVERUSE DISORDER.
SO WE HAVE, YOU KNOW, 2 MILLION
PEOPLE ARE OPIOID OVERUSE
DISORDER, 40 TO 60% HAVE CHRONIC
PAIN.
THIS IS SOMETHING THAT THE
PHYSICIANS, PRIMARY CARE
PHYSICIANS, REALLY TRY AND STAY
AWAY FROM AND UNFORTUNATELY
THESE PEOPLE ARE POORLY SERVED.
IT PROBABLY MAKES THEIR --
DEFINITELY MAKES THEIR PAIN
WORSE, PROBABLY ALSO LEADS TO
WORSE OPIOID OVERUSE DISORDER,
LESS CHANCE OF GETTING INTO AND
GETTING A RECOVERY, GOOD
RECOVERY STATUS.
BUT WE HAVE A NUMBER OF
POPULATIONS THAT WE'RE LOOKING
AT IN THIS SPACE.
MAT IS MEDICATION-ASSISTED
THERAPY.
AND THE INTERVENTIONS SEEN HERE.
AGAIN, THEY SPAN MEDICAL, BUT
ALSO COMBINING WITH
SELF-MANAGEMENT, PAIN
SELF-MANAGEMENT, MINDFULNESS AND
EXERCISE, FOR INSTANCE.
AND THE SETTINGS SEEN HERE GOING
TO BE A PLACE WHERE THESE FOLKS
ARE POTENTIALLY RECRUITABLE,
PRIMARY CARE, AND THE V.A. AND
SOMETIMES HOSPITAL SETTINGS AS
WELL.
NEXT SLIDE.
TRYING TO ADVANCE HEALTH EQUITY
IN THE PAIN SPACE, I THINK WE
HAVE TO THINK ABOUT THIS AS A
SYSTEMIC ISSUE THAT HAS
DIFFERENT FACTORS, EACH OF WHICH
HAVE TO BE INCORPORATED INTO ANY
PLAN.
SO THERE ARE INDIVIDUAL
BIOSOCIAL FACTORS WHICH PROBABLY
AFFECT HOW PEOPLE PERCEIVE PAIN
AND HOW MUCH SUFFERING IS
ASSOCIATED WITH DIFFERENT
NATURAL STIMULI, PROBABLY
CULTURAL VARIATIONS NOT ONLY
WHAT PEOPLE EXPERIENCE, REALLY
HARD TO UNDERSTAND, BUT MAYBE
MORE SO IN HOW PEOPLE
COMMUNICATE WHAT THEY ARE
EXPERIENCING.
THIS CAN CERTAINLY LEAD TO REAL
HEALTH INEQUITIES IF PEOPLE --
IF THE PERSON IN FRONT OF YOU IS
NOT QUESTIONED TO GET AT THE
BASIS OF WHAT DEGREE OF
SUFFERING THEY ARE HAVING.
INTERPERSONAL PATIENT-PROVIDER
INTERACTIONS ARE IMPORTANT,
SUCCESS RELIES ON TRUST OF
PROVIDER AND PATIENT, HOW TO
BUILD TRUST, PARTICULARLY WHEN
THE WORKFORCE DOESN'T LOOK LIKE
THE PERSON WHO IS TRYING TO COME
TREATMENT OF PAIN.MS OF THE%-
AND SO HOW TO WORK THIS SO WE
GET THE BEST OUTCOMES IS REALLY
IMPORTANT.
THEN THERE ARE COMMUNITY AND
SOCIOECONOMIC FACTORS IN A HAVE
TO BE TAKEN INTO ACCOUNT, SOME
OF THESE ARE, YOU KNOW, ACCESS
TO THERAPY.
IF YOU CAN'T TAKE OFF FROM WORK
TO GET TO THE CLINIC OR YOU
DON'T HAVE THE FUNDING TO GET
THE TRANSPORTATION, AGAIN, THESE
ARE THINGS THAT YOU DON'T THINK
ABOUT THEM, THEY CAN REALLY
AFFECT THE RESEARCH OUTCOME AND
ALSO AFFECT THE POPULUS THAT
YOU'RE ACTUALLY RELEVANT TO.
AND WE HAVE TO WORK WITHIN THE
SYSTEMS THAT WE HAVE, BUT WE
HAVE THE OPPORTUNITY AS THE NIH
TO WORK WITH HEALTHCARE SYSTEMS
TO GENERATE KIND OF BETTER WAYS
OF DEALING WITH CHRONIC PAIN
THAT BENEFITS THE PATIENTS AND
BENEFITS THE HEALTHCARE SYSTEM.
AGAIN, POPULATIONS THAT WE'RE
TRYING TO ENGAGE IN OUR EFFORTS
TO IMPROVE HEALTH EQUITY, AND
THE PAIN CONDITIONS AND THE
INTERVENTIONS THAT ARE BEING
TESTED AND DIFFERENT SETTINGS AT
WHICH THESE ARE OCCURRING, AND
THEN, AGAIN, THESE TABLES WERE
BUILT BY CLINICAL RESEARCH TEAMS
WHO KNOW EXACTLY WHICH GRANT IS
TESTING WHAT AND WHAT SETTING
AND FOR WHAT POPULATION.
NOW, I MENTIONED EARLIER THAT
THE WORKFORCE, PARTICULARLY IN
THE CLINICAL PAIN SPACE, NEEDS
TO BE STRENGTHENED GREATLY.
AS I MENTIONED EARLIER, THERE'S
BEEN EXPLOSION IN THE
NEUROSCIENCE OF PAIN.
LARRY TALKED TO YOU ABOUT, YOU
KNOW, THIS NEW STUDY THAT JUST
CAME OUT WHERE YOU CAN ACTUALLY
SEE SIGNATURES IN THE
OSCILLATORY PATTERNS, ELECTRICAL
ACTIVITY IN CERTAIN PARTS OF THE
BRAIN.
NOT ONLY THAT, YOU CAN STIMULATE
REGIONS TO CHANGE THAT
OSCILLATORY ACTIVITY AND IMPROVE
THE PERCEPTION OF PAIN.
THIS WAS, YOU KNOW, AS WAS
MENTIONED A VERY SMALL GROUP,
PEOPLE WHO HAD PAIN DUE TO
DAMAGE TO THEIR BRAIN, SO
NEUROGENIC PAIN REALLY, BUT THIS
IS WHAT -- THIS IS THE ORIGIN OF
THE PAIN PERCEPTION THAT WE'RE
FINALLY GETTING AT, AND TAKING
THIS KIND OF KNOWLEDGE AND
PUTTING IT TO PRACTICE TAKES
REALLY SPECIALTY HIGH-EXPERIENCE
PEOPLE AND NEED TO BUILD THAT.
"HEAL" HAS A NUMBER OF PROGRAMS,
I DON'T THINK THEY ARE EVEN ALL
ON THIS LIST, K FELLOWSHIP
PROGRAMS, ADMINISTRATIVE
SUPPLEMENTS OF SUPPORT FOR
CAREER ENHANCEMENT, MID-YEAR
INVESTIGATOR AWARD,
PATIENT-ORIENTED RESEARCH, A NEW
K-12 PROGRAM RUN BY UNIVERSITY
OF MICHIGAN, AND THEY RECRUIT
PEOPLE AND THEY WILL MENTOR OVER
THE YEARS AND DEVELOP THEIR
CAREERS IN PAIN RESEARCH.
AND AS LARRY MENTIONED, THIS
ACROSS THE COUNTRY, COORDINATING
ALL OUR TRAINING PROGRAMS UNDER
THIS PURPOSE GROUP WHICH IS
ACTUALLY A COMPANY THAT DOES
EDUCATION, HEALTH EDUCATION, SO
REAL PROFESSIONALS.
I WAS HAPPY TO GO TO THE LAUNCH
OF THEIR FIRST MEETING WHERE
THEY BROUGHT IN TRAINEES AND
MENTORS FROM ALL OVER THE
COUNTRY IN THE HEAL INITIATIVE
AND DID A FANTASTIC JOB KIND OF
CREATING THE IMPORTANT
CONVERSATIONS AND DISCUSSIONS
AND I THINK IT'S A REALLY UNIQUE
BUT REALLY POWERFUL PROGRAM THAT
"HEAL" IS PILOTING HERE.
NEXT SLIDE.
AND, YES, WE MENTIONED ALREADY
THAT IN THE PAIN SPACE WE ARE
ATTEMPTING TO REDUCE THE
SUFFERING THAT'S RELATED TO THIS
ACTIVATION OF THE NOCICEPTIVE
SYSTEMS, WHICH THEN CHANGE WITH
CHRONIC PAIN OVER TIME.
AND SO PAIN IS BY DEFINITION A
VERY SUBJECTIVE EXPERIENCE, AND
TO UNDERSTAND HOW WE MOVE
FORWARD WE REALLY NEED TO BE
LISTENING TO THE PEOPLE WHO ARE
ACTUALLY THE PARTICIPANTS IN THE
RESEARCH, AND PEOPLE WITH LIVED
EXPERIENCE, AND WE HAVE A GREAT
"HEAL" COMMUNITY PARTNERSHIP
COMMITTEE THAT IS GIVING I THINK
REALLY AMAZING INPUT ON KEY
ISSUES, NOT ONLY FOR THOSE
AFFECTED BY PAIN BUT ALSO
SUBSTANCE ABUSE AND CLEARLY
THERE'S THAT INTERACTION BETWEEN
THESE TWO ISSUES.
AND THEY HELPED US TO IDENTIFY,
REFINE, PRIORITIZE ENGAGEMENT
ACTIVITIES IN THE "HEAL"
PROGRAMS.
WHEN I LOOK ACROSS WHAT WE DO AT
NINDS, "HEAL" IS REALLY THE ROLE
MODEL RIGHT NOW FOR COMMUNITY
ENGAGEMENT.
WE'RE TRYING TO TAKE THIS WORK
PACKAGE AND EXPORT IT TO A LOT
OF THINGS THAT WE DO AT NINDS,
BECAUSE WE THINK IT'S SO
IMPORTANT.
AND WE ALSO MAKE SUPPLEMENTS TO
THE PROGRAM.
YOU CAN'T ASK PEOPLE TO DO THIS
JUST ON ALTRUISM.
WE NEED TO PAY PEOPLE WITH LIVED
EXPERIENCE THAT TAKE PART IN THE
RESEARCH LIKE WE WOULD PAY
ANYBODY ELSE IN THE RESEARCH
PROGRAM.
THEIR INPUT IS NO LESS VALUABLE
THAN ANYONE ELSE'S, AND SO THESE
SUPPLEMENTS ARE I THINK
IMPORTANT IN BUILDING COMMUNITY
PARTICIPATION INTO THE "HEAL"
PROGRAM.
NEXT SLIDE.
AND JUST TO SAY THAT THE HOPE
TRIAL IS COMPLETING ITS
RECRUITMENT, 643, IN 2023, A
HIGHLY ENGAGED PATIENT
POPULATION.
WE TALK ABOUT PATIENT
ENGAGEMENT, "HEAL" IS A MODEL
FOR NINDS, THE HOPE PROJECT WAS
A MODEL FOR "HEAL."
SO WE REALLY LEARNED A LOT BY
WORKING WITH THE FOLKS IN THE
HOPE PROJECT.
NEXT SLIDE.
ALSO, THE PRESCRIPTION AFTER
CASAREAN TRIAL, WOMEN ARE
PRESCRIBED AFTER C-SECTIONS, 20
TABLETS, 15 TABLETS, AND THE
IDEA IS TO SHOW AND THEY SHOWED
ONE WEEK POST-DISCHARGE.
AND THERE WAS NO DIFFERENCE IN
FULFILLING REFILLS.
THE RESOLVE STUDY WHICH I THINK
IS LINDA, IF I'M NOT MISTAKEN,
MULTI-CENTER TRIAL FROM KAISER
WASHINGTON, NORTHWEST, AND
GEORGIA, AND ESENTIA HEALTH,
TELEPHONE AND VIDEO CONFERENCE
SO COULD WORK DURING COVID, A
WEB PROGRAM, PAIN TRAINER, 3-ARM
PARALLEL INTERVENTION DESIGN,
COMPLETE ENROLLMENT OF 2231
PATIENTS, MANY RURAL AND OLDER
ADULTS, 30% REDUCTION OVERALL
PAIN SCORE.
SO HOPEFULLY THESE KIND OF
THINGS CAN THEN -- THEY ARE IN
THE KAISER SYSTEM, HOPEFULLY THE
HEALTHCARE SYSTEM CAN ADAPT
THESE PROGRAMS WHEN WE SHOW THEM
TO BE SUCCESSFUL.
NEXT SLIDE.
AND WITH THAT I WANT TO CONCLUDE
AND CAN'T CONCLUDE WITHOUT
THANKING ALL THE PEOPLE WHO DID
SO MUCH WORK TO BUILD THE HEAL
INITIATIVE, BOTH IN THE OFFICE
OF THE DIRECTOR, MULTIPLE
DIFFERENT INSTITUTES, DIFFERENT
I.C. DIRECTORS, SUCH A VIBRANT
PROGRAM, AND IT'S BEEN JUST A
JOY TO BE PART OF IT.
THANK YOU.
>> THANK YOU FOR THE BROAD AND
DEEP OVERVIEW.
DO WE HAVE DR. CRISWELL?
>> YES, I'M HERE.
CAN YOU HEAR ME?
>>I'M GOING TO JUST POINT OUT
WE'RE A LITTLE BIT OVER TIME
RIGHT NOW.
AND SO PLEASE KEEP THAT IN MIND
AS YOU GIVE US THIS MUCH-AWAITED
UPDATE ON THE BACK PAIN
CONSORTIUM RESEARCH PROGRAM,
WHAT WE CALL BACPAC.
ONE OF THE MORE FOCUSED PAIN
MANAGEMENT RESEARCH EFFORTS BUT
HIGHLY COLLABORATIVE AND
INTERDISCIPLINARY EFFORTS
UNDERWAY LED BY NIAMS.
>> THANKS FOR THE OPPORTUNITY
TO PROVIDE THIS UPDATE.
"HEAL" IS CONCERNED NOT ONLY
WITH OPIOID ADDICTION BUT CAUSES
OF OPIOID ADDICTION, CERTAINLY
CHRONIC PAIN IS A COMMON CAUSE
OF OPIOID ADDICTION, AS YOU
HEARD ALREADY BACK PAIN IS A
VERY COMMON CAUSE OF ACUTE AND
CHRONIC PAIN.
SO HENCE THE FOCUS OF THE
PROGRAM.
NEXT SLIDE.
SO, THE BACK PAIN CONSORTIUM,
BACPAC, AIMS TO PROVIDE
TREATMENT FOR INDIVIDUALS
THROUGH DISCOVERING MECHANISMS
OF CHRONIC LOW BACK PAIN AND
IDENTIFYING AND TESTING NEW
INTERVENTIONS TARGETED TO
INDIVIDUAL PATIENTS, A REALLY
IMPORTANT FEATURE.
SO, ON THE NEXT SLIDE, BACPAC IS
A PATIENT CENTERED RESEARCH
PROGRAM, AT THE BASIC RESEARCH
LEVEL BACPAC WILL DEVELOP AN
INTEGRATED THEORETICAL MODEL OF
CHRONIC LOW BACK PAIN BASED ON
IMPROVED UNDERSTANDING OF
MECHANISMS AND CLINICAL TRIALS
AND MULTI-MODAL, CREATING
CLINICAL COHORTS WITH VERY DEEP
PHENOTYPING INCLUDING
PATIENT-REPORTED OUTCOMES, AND
AT THE CLINICAL LEVEL BACPAC
AIMS TO CREATE ALGORITHMS TO
MATCH EACH PATIENT TO THE BEST
TREATMENTS BASED ON THEIR
PHENOTYPE AND THEIR PSYCHOSOCIAL
CONTEXT.
SO, NEXT SLIDE.
SO, TO ADDRESS THESE VARIOUS
ELEMENTS BACPAC INCLUDES SEVERAL
COMPONENTS, THREE RESEARCH
CENTERS, EACH RUN THEIR OWN
STUDIES, COLLECT BIOLOGICAL,
MECHANICAL, PSYCHOSOCIAL, AND
OTHER DATA FROM PATIENTS TO
IDENTIFY DIFFERENT PHENOTYPES,
AND HENCE POSSIBLE MARKERS OF
TREATMENT RESPONSE.
THE TECHNOLOGY RESEARCH SITES
CREATE, TEST, AND DISTRIBUTE
TECHNOLOGY AND METHODS TO TEST
AND QUANTIFY AND RELIEVE CHRONIC
LOW BACK PAIN.
AND THEN THERE ARE THREE PHASE 2
CLINICAL TRIALS ADDRESSING
DIFFERENT INTERVENTIONS.
IMPORTANTLY THERE'S A DATA
INTEGRATION ALGORITHM
DEVELOPMENT AND OPERATION CENTER
THAT PLAYS A CRUCIAL ROLE TO
COORDINATE AND HARMONIZE DATA
AND CONSORTIUM ACTIVITIES.
I'M GOING TO VERY BRIEFLY TOUCH
UPON THESE COMPONENTS IN THE
NEXT FEW SLIDES, IF YOU CAN GO
ON.
SO FIRST THE MECHANISTIC
RESEARCH CENTERS, REACH MRC
EXAMINING BIOSOCIAL, RELIES UPON
TWO OBSERVATIONAL COHORTS, AS
SHOWN ON THE SLIDE, AND THE
HEALING LB3P IS COLLECTING DATA
WITH OVER 750 ENROLLEES TO DATE,
AND THEN THE THIRD MECHANIC MEC
CENTER IS RUNNING WITH A SMART
DESIGN TO IDENTIFIED PREDICTING
RESPONSES TO FOUR INTERVENTIONS,
MINDFULNESS, PHYSICAL THERAPY,
ACUPRESSURE AND DULOXETINE, WITH
A SIGNIFICANT AMOUNT OF WORK
BEFORE THE STUDIES BEGAN.
FOR EXAMPLE ALL THE DATA
COLLECTION APPROACHES WERE
STANDARDIZED AND HARMONIZED
ENSURING VERY RICH DATASETS THAT
CAN BE ACCESSED AND INTEGRATED
ACROSS EFFORTS.
SO ON THE NEXT SLIDE, THIS
HIGHLIGHTS THE EXCITING
TECHNOLOGY DEVELOPMENT SITES,
THERE ARE SEVEN OF THESE.
I WON'T GO THROUGH ALL BUT
STARTING AT THE LOWER LEFT
YOU'LL SEE THAT THESE DEVELOP
ROBOTIC APPAREL, DIGITAL
PLATFORM EFFORTS, MEASURING END
PLATE PATHOLOGY, MEASURING
DENSITY IN THE BRAIN, USE OF
NANOCOMPOSITE SENSORS IN
ADDITION LASTLY TO USE OF
FOCUSED ULTRASOUND, EXCITING
TECHNOLOGIES THAT ARE BEING
STUDIED, AND SOME OF THESE
RESULTS HAVE BEEN PUBLISHED SUCH
AS IMPROVEMENTS IN THE
TECHNOLOGY AROUND SPINE MRIs.
SO IF YOU GO TO THE NEXT SLIDE,
THE THIRD COMPONENT IS THE THREE
PHASE 2 CLINICAL TRIALS,
DEPICTED ON THE SLIDE EXAMINING
VIRTUAL REALITY PROTOCOLS TO
MANAGE BACK PAIN, EXPLORING
COMBINATION OF ANTIDEPRESSANTS
AND ENHANCED FEAR AVOIDANCE
REHABILITATION PROTOCOL FOR
PATIENTS WITH LOW BACK PAIN AND
DEPRESSION OR ANXIETY, AND A
TRIAL BY FRITZ AND COLLEAGUES
THAT LOOKS FOR WHETHER A
COMPREHENSIVE PROGRAM TO IMPROVE
THE PATIENT'S ABILITY AND
CONFIDENCE IN MANAGING THEIR OWN
PAIN BEFORE SURGERY CAN REDUCE
RISK OF POST-SURGICAL OPIOID
USE.
NEXT SLIDE JUST ILLUSTRATES THE
THREE VIRTUAL REALITY PROTOCOLS
FOR THAT FIRST TRIAL THAT I
MENTIONED, ONE BEING SHAM
INTERVENTION, ANOTHER BEING AN
IMMERSIVE DISTRACTIVE
INTERVENTION AND THEN THE THIRD
IS IMMERSIVE SKILLS-BASED
VIRTUAL REALITY PROTOCOL.
WE'RE REALLY EXCITED ABOUT ALL
OF THESE EFFORTS.
ON THE NEXT SLIDE, COLLABORATION
IS VERY IMPORTANT AT "HEAL," AND
IMPORTANT IN BACPAC, AIMING TO
CAPITALIZE ON DATA AND
BRAINPOWER ACROSS THE CONSORTIUM
TO ENABLE NEW PARADIGMS IN THE
TREATMENT OF CHRONIC LOW BACK
PAIN, THIS INCLUDES OF COURSE
HARMONIZING DATA COLLECTION AS
I'VE MENTIONED, CREATING
THEORETICAL MODEL OF CHRONIC LOW
BACK PAIN AND ALSO LAUNCHING A
COLLABORATIVE MULTI-SITE
CLINICAL TRIAL CALLED THE BEST
TRIAL, WHICH I'LL ALSO DESCRIBE
IN JUST A MINUTE.
BUT TO ENSURE HARMONIZATION OF
THE DATA COLLECTION MEASURES AND
PROTOCOLS, WORKING GROUPS WERE
CREATED TO STANDARDIZE
BIOBEHAVIORAL, BIOMECHANICAL,
BIOSPECIMEN AND IMAGING AND DATA
COLLECTION IN BACPAC, MADE
PUBLICLY AVAILABLE.
I MENTIONED THIS THEORETICAL
MODEL, AN IMPORTANT ASPECT OF
THE EFFORTS, SHOWN ON THE NEXT
SLIDE.
THE BACPAC INVESTIGATORS
ESTABLISHED THIS FOR PHENOTYPES,
INTERVENTIONS, EXPLANATORY
THEORIES, MACHINE LEARNING, ET
CETERA.
THE MODEL AIMS TO INTEGRATE
FACTORS INTERNAL AND EXTERNAL,
THAT AFFECT PAIN PROCESSING.
THIS INCLUDES MECHANISMS IN THE
LOWER BACK, THAT'S REPRESENTED
IN THE BOTTOM CIRCLE, DORSAL
HORN AND SPINAL CORD,
REPRESENTED IN THE MIDDLE
CIRCLE, AND THEN THE BRAIN
CAPTURED IN THE UPPER CIRCLE.
SO THESE ALL CONTRIBUTE TO AN
INDIVIDUAL'S EXPERIENCE OF PAIN,
AND THIS EXPERIENCE CAN BE
INDIRECTLY ASSESSED USING
VARIOUS MEASURES OF PAIN AND
DISABILITY.
SO THE MODEL WAS DERIVED BY
INTEGRATING EXPERT OPINIONS ON
THE RISK AND PROGNOSTIC FACTORS
WITH RESULTS OF EXTENSIVE
LITERATURE REVIEW WHICH ASSESSED
OVERALL STRENGTH OF EVIDENCE FOR
IDENTIFIED RISK FACTORS AND OF
COURSE OVER THE COURSE OF THIS
PROGRAM THE MODEL WILL BE
REFINED BASED ON BACPAC DATA AND
OTHER DATA TO REFLECT A
STATE-OF-THE-ART MODEL FOR
CHRONIC LOW BACK PAIN.
AND AS THE SLIDE INDICATES, THE
MODEL AND PROCESS TO DEVELOP
WERE RECENTLY PUBLISHED.
SO IF YOU GO TO THE NEXT SLIDE.
I MENTIONED ANOTHER FEATURE OF
THIS PROGRAM THAT WE'RE EXCITED
ABOUT WHICH IS THE BEST TRIAL,
THE BIOMARKERS FOR EVALUATING
SPINE TREATMENTS, A FOUR-ARM
SMART TRIAL, DESIGNED TO
ESTIMATE AN ALGORITHM, ASSIGN
SEQUENCE OF TWO TREATMENTS FOR
CHRONIC LOW BACK PAIN, BASED ON
A PATIENT'S PHENOTYPIC MARKERS
SO THE TRIAL IS EXPLORING FOUR
INTERVENTIONS THAT HAVE BEEN
SHOWN TO HAVE SOME EFFECTIVENESS
FOR CHRONIC LOW BACK PAIN
PATIENTS.
THIS INCLUDES ENHANCED
SELF-CARE, ACCEPTANCE AND
COMMITMENT THERAPY, EVIDENCE
BASED EXERCISE AND MANUAL
THERAPY, AND THEN DULOXETINE.
IMPORTANTLY THE TRIAL IS POWERED
TO IDENTIFY WHICH TREATMENT WILL
BE BEST FOR WHICH SUBGROUP OF
PATIENTS, INSTEAD OF FOCUSING ON
AVERAGE EFFECTS ON A GROUP OF
PATIENTS.
NEXT SLIDE, WHICH I WON'T GO
OVER IN DETAIL, SHOWS THE
PROTOCOL.
THERE ARE TWO TREATMENT PERIODS,
ALL PARTICIPANTS ARE RANDOMIZED
TO ONE OF THE FOUR IN THE FIRST
PERIOD, TREATMENT IN SECOND
PERIOD DEPENDS ON INITIAL
RESPONSE TO FIRST TREATMENT.
PARTICIPANTS ARE PHENOTYPED AT
THREE TIME POINTS, IMPORTANT
GIVEN THE GOALS, BEFORE EACH OF
THE TWO TREATMENT PERIODS,
DURING THE FOLLOW-UP.
ALL PARTICIPANTS UNDERGO LIGHT
PHENOTYPING
BASIC BIOMECHANICS, CLINICAL
SPINE MRI FINDINGS, X-RAY
IMAGES, AND A SUBSET ALSO
UNDERGO DEEP PHENOTYPING
ADVANCED BIOMECHANICS, ADVANCED
MRI, BRAIN MRI, QUANTITATIVE
SENSORY TESTING RESULTS.
NEXT SLIDE.
THIS SHOWS THE TIMELINE.
THE TRIAL WAS LAUNCHED LAST
SEPTEMBER.
WE ANTICIPATE ENROLLMENT TO END
IN SEPTEMBER OF THIS YEAR ALLOW
THE TRIAL TO COMPLETE IN
SEPTEMBER OF 2024.
AND LASTLY, THINKING ABOUT THE
WHOLE SYSTEM, AS YOU'VE HEARD,
MOVING FORWARD, NEXT SLIDE,
SORRY, WE AIM TO BUILD ON BACPAC
AS WELL AS OTHER "HEAL" PROGRAMS
SUCH AS REJOIN THAT SOME OF YOU
MAY HAVE HEARD ABOUT TO DEVELOP
A WHOLE JOINT PERSPECTIVE.
SO, WE RECOGNIZE THE NEED TO
INTEGRATE INFORMATION ACROSS ALL
DOMAINS, MANY ARE DEPICTED HERE,
ENVIRONMENT, BEHAVIOR,
MECHANICS, AS WELL AS TISSUE,
CELLULAR, MOLECULAR PROCESSES,
TO MAINTAIN HEALTH, PREVENT OR
ADDRESS PAIN AND PREVENT
ADDICTION.
SO, THIS WILL BEGIN BY
INTEGRATING INFORMATION FROM THE
VARIOUS "HEAL" PROGRAMS, I'VE
TALKED ABOUT BACPAC THIS MORNING
BUT WE ALSO HOPE TO LEARN ABOUT
KNEE AND TMJ INNERVATION TO
REJOIN, APPLY TO BACK PAIN AND
OTHER JOINT PAIN, BUILD ON
BIOMARKERS THAT YOU ALSO HEARD
ABOUT TO DEVELOP BIOMARKERS FOR
PAIN IN OTHER JOINTS, EXPLORING
HOW CELLULAR MOLECULAR AND
GENETIC INFORMATION FROM THE PRO
SITUATION PROGRAM WILL INFORM
DEVELOPMENT OF BIOMARKERS FOR
OTHER TYPES OF PAIN AND EXAMINE
WAYS TO SHARE CLINICAL DATA,
TISSUES, AND OTHER RESOURCES
ACROSS PROGRAMS TO BETTER
LEVERAGE RESEARCH OPPORTUNITIES.
MY LAST SLIDE, WHICH IS MOSTLY
BLANK BUT REPRESENTS MANY, MANY,
MANY PEOPLE, I WANT TO THANK THE
RESEARCHERS PARTICIPATING IN
BACPAC, BACPAC STAKEHOLDERS AND
BOARD MEMBERS, I CERTAINLY WANT
TO ACKNOWLEDGE THE NIH PROGRAM
STAFF WHO MANAGE THIS COMPLEX --
THESE COMPLEX AWARDS, INCLUDING
LESLIE AND ERIN, CHUCK, TED, AND
MANY OTHER PROJECT SCIENTISTS
AND PROJECT COORDINATORS FROM
MULTIPLE INSTITUTES, CENTERS,
OFFICES, AND OF COURSE
ACKNOWLEDGE THE PATIENTS WITHOUT
WHOM WISH THIS WOULDN'T BE
POSSIBLE.
OUR HOPE IS DEVELOP CLEAR
GUIDELINES TO INDIVIDUALIZE
TREATMENT FOR CHRONIC LOW BACK
PAIN.
BACK TO YOU, DR. BAKER.
>> THANK YOU, DR. CRISWELL.
I WOULD LIKE TO MAKE SURE WE
HAVE TIME FOR DISCUSSION.
I'LL GO THROUGH MY SLIDES NOW
QUICKLY AND THOSE OF YOU WHO
HAVE QUESTIONS FOR DR. KOROSHETZ
OR CRISWELL PLEASE SAVE THEM FOR
THE GENERAL DISCUSSION THAT WILL
FOLLOW MY BRIEF TALK NOW.
YOU HAVE HEARD A LOT ABOUT
SPECIFIC PROGRAMS AND PROJECTS
WITHIN "HEAL."
I'LL NOW TAKE A STEP OR TWO BACK
AND JUST REMIND YOU IN THE NEXT
SLIDE OF WHAT THE OVERARCHING
VISION IS FOR THIS, HELPING TO
END ADDICTION LONG-TERM
INITIATIVE TO COMBINE SCIENCE,
EFFORTS OF SCIENTISTS AND
RESEARCH COMMUNITY TO THE
STRENGTHS AND POWER OF THE
COMMUNITIES IN WHICH OUR
PATIENTS AND STAKEHOLDERS LIVE
TO PROVIDE SCIENTIFIC SOLUTIONS
AND HELP END ADDICTION LONG
TERM.
THIS MISSION INCLUDES EFFORTS TO
ACCELERATE DEVELOPMENT OF NEW
TREATMENTS, SAFE, NON-ADDICTIVE
STRATEGIES TO PREVENT AND TREAT
PAIN, OPIOID MISUSE, ADDICTION,
TO REVERSE OVERDOSE.
IN THE NEXT SLIDE I SHOW JUST --
DR. TABAK MENTIONED THESE SO
I'LL BE QUICK, BUT CHRONIC PAIN
IS NOT GOING AWAY.
IT AFFECTS SO MANY MILLIONS OF
AMERICANS, HAS INCREDIBLE BURDEN
OF DISEASE AND REALLY AFFECTS
QUALITY OF LIFE FOR MANY PEOPLE
AND MANY PEOPLE WITH OTHER
HEALTH CONDITIONS.
AND A PARALLEL TRACK, WE HAVE
RECORD NUMBERS OF DRUG OVERDOSES
AFFECTING FAMILIES, COMMUNITIES,
INDIVIDUALS ACROSS THE COUNTRY,
DRIVEN BY THE INCREASING
ACCESSIBILITY OF FENTANYL AND
CONTAMINATION OF FENTANYL AND
DIFFERENT DRUGS, BUT ALSO A LACK
OF INFRASTRUCTURE AND COMMUNITY
SUPPORT FOR SOME OF THE
EFFECTIVE INTERVENTIONS THAT WE
HAVE.
AND THEN LASTLY WE HAVE OUR
BIOPHARMACEUTICAL PARTNERS WHO
HAVE INTERESTING, INNOVATIVE
APPROACHES AND ABILITY TO
COMMERCIALIZE THESE TO PROVIDE
THESE NEW TREATMENTS, AND YET
WE'RE NOT SEEING INVESTMENTS AND
PROGRESS OF MANY OF THE PROGRAMS
THAT WE'RE AWARE OF AND THAT
COULD BE SCIENTIFIC SOLUTIONS
WE'RE SEEKING FOR PEOPLE WITH
PAIN AND ADDICTION.
SO THIS IS OUR LANDSCAPE.
AND NEXT SLIDE, I BEGIN TO TALK
ABOUT SOME OF THE WAYS "HEAL"
RESEARCH IS MEETING THIS
CHALLENGE.
THE FIRST EXAMPLE, NEXT SLIDE,
IS THE STUDY, YOU WILL RECALL
THE GROUP OF NEONATOLOGISTS AND
NURSES WHO CONTRIBUTED TO THIS
STUDY LED BY THE ECHO PROGRAM
WITH NICHD, NATIONAL INSTITUTE
ON CHILD HEALTH.
WE HAVE INFANTS BORN EXPOSED TO
OPIOIDS, UNDERGOING WITHDRAWAL
IN THE NICU, RESEARCH UNDERWAY
TO UNDERSTAND THE BEST WAY OF
EVALUATING THEIR LONG-TERM
DEVELOPMENT BUT IN THE SHORT
TERM WAYS TO ADDRESS WITHDRAWAL
SYSTEMS; THE EAT, SLEEP, CONSOLE
APPROACH, WHETHER THEY ARE ABLE
TO EAT, SLEEP, BE CONSOLED WAS
TESTED, RANDOMIZED CLINICAL
TRIAL FOUND TO REDUCE TIME IN
THE HOSPITAL AND REDUCE AMOUNT
OF OPIOID MEDICATIONS NEEDED TO
ADDRESS THOSE WITHDRAWAL
SYMPTOMS.
NEXT SLIDE.
FINDINGS THAT DR. KOROSHETZ
MENTIONED, I WON'T LINGER ON,
BUT THERE ARE BEGINNING TO BE
STUDIES THAT CAN IMAGE THE BRAIN
AND UNDERSTAND THE CHRONIC PAIN
SIGNATURES THAT ARE DIFFERENT
AMONG INDIVIDUALS, IN THIS CASE
PAIN CAUSED BY STROKE OR
AMPUTATION, AND THESE
PATIENT-SPECIFIC SIGNALS CAN
GIVE A PROMISE TO OUR COMMUNITY
IN TERMS OF WHAT WE COULD BEGIN
TO ADDRESS, HOW WE COULD BEGIN
TO PERSONALIZE THE TREATMENT FOR
PEOPLE WITH CHRONIC PAIN.
NEXT SLIDE PLEASE.
WE ALSO HAVE -- DR. D'ONOFRIO IS
ONE OF THE LEADS FOR THIS TRIAL,
OR THE LEAD, THRUST WITHIN HEAL,
BUPRENORPHINE FOR TREATMENT OF
OPIOID USE DISORDER, IN THE
EMERGENCY DEPARTMENT, HOPEFULLY
RESULTING IN GREATER ACCESS AND
USE OF THE LIFE-SAVING
MEDICATIONS FOR TREATMENT OF
OPIOID USE DISORDER THAT WE
HAVE, WE KNOW WORK, AND WAYS TO
INTEGRATE INTO CLINICAL CARE.
SO, SIGNS OF PROGRESS TO ADDRESS
THE REALLY SIGNIFICANT
CHALLENGES WE'RE FACING AS A
COUNTRY IN OUR PAIN AND
ADDICTION CRISES.
NEXT SLIDE PLEASE.
A REMINDER OF WHAT WE'RE SEEKING
TO DO.
THIS KIND OF IS INTENDED TO
PROVIDE INTRODUCTION TO SOME OF
THE RESEARCH PROGRAMS YOU'LL
HEAR ABOUT IN THE SECOND HALF F
THE MEETING, STRATEGIES TO
REDUCE RISK OF ADDICTION AND
INTEGRATE EFFECTIVE AND
SUSTAINABLE PREVENTION AND
TREATMENT STRATEGIES, INCLUDING
IMPLEMENTING INTO COMMUNITY AND
SUSTAINABLE FRAMEWORKS THAT CAN
BE TAKEN UP AND USED TO SAVE
LIVES.
RESEARCH TO SUPPORT HEALTHY
DEVELOPMENTAL PATHS FOR BABIES
EXPOSED TO OPIOIDS USING
UNDERSTANDING HOW A MOTHER'S
SUBSTANCE USE CAN CONTRIBUTE TO
THEIR LONG-TERM HEALTH AND NEW
THERAPEUTICS FOR THE CYCLE,
WITHDRAWAL, OPIOID USE DISORDER,
AND OVERDOSE.
NEXT SLIDE PLEASE.
PLEASE GO TO OUR WEBSITE, YOU'LL
SEE A LOT MORE INFORMATION ABOUT
THE RESEARCH FINDINGS THAT ARE
COMING THROUGH, AND ALSO THE
WAYS THAT WE'RE SEEKING TO BUILD
THE RESEARCH COMMUNITY TO BETTER
PREPARE FOR THESE CRISES AS THEY
CONTINUE TO EVOLVE.
NEXT SLIDE PLEASE.
A LITTLE BIT OF WHERE WE ARE NOW
IS IN THE FOLLOWING SLIDE.
WE HAVE AN ANNUAL REPORT THAT
DETAILS A LOT MORE PROGRESS AND
UPDATES ON THE RESEARCH THAT WE
HAVE LAUNCHED SINCE YOU STARTED
WORKING WITH US, DEVELOPING AND
BUILDING THE HEAL INITIATIVE,
INCLUDING SOME OF THE SCREENING
PLATFORMS, DECISION TOOLS,
COMMUNITY-BASED APPROACHES TO
HELP END ADDICTION LONG TERM AS
WELL AS SOME WAYS WE'RE
LEVERAGING OUR DATA ECOSYSTEM, I
HOLD YOU ABOUT THOSE IN THE
PAST, AND CONTINUING TO BUILD
CONNECTIONS WITH THE USERS AND
PRACTITIONERS WHO ARE GOING TO
TAKE RESEARCH FINDINGS AND TURN
THEM INTO SOLUTIONS FOR PEOPLE
WITH PAIN AND ADDICTION.
NEXT SLIDE PLEASE.
WE CONVENED THE "HEAL"
INVESTIGATORS COMMUNITY, THERE
WERE OVER 600 PEOPLE THERE,
VIRTUAL AND IN PERSON, FOCUS ON
EARLY STAGE INVESTIGATORS AND
SOME OF THE EXCITING AREAS OF
SCIENCE THAT ARE COMING THROUGH.
SO THANK YOU FOR THOSE WHO TOOK
PART AND TUNED IN.
NEXT SLIDE PLEASE.
AND WHERE ARE WE NOW?
WITH OVER $2.5 BILLION DIRECTED
TOWARDS RESEARCH IN PAIN AND
ADDICTION, OVER 1,000 PROJECTS,
ALL 50 STATES, YOU HEARD ABOUT
OVER 300 CLINICAL TRIALS THAT WE
HAVE UNDERWAY, INCLUDING OVER
100 PROJECTS ADDRESSING BACK
PAIN, THIS HAS LED TO OVER 40
FDA APPROVALS FOR
INVESTIGATIONAL NEW DRUGS AND
DEVICES.
THESE ARE IND SUBMISSIONS TO THE
FDA THAT SEEK TO BRING FORWARD
THOSE INNOVATIONS TO PRODUCTS
THAT CAN BE USED BY PATIENTS,
AND OF COURSE ACTIVE ONGOING
PARTNERSHIPS WITH FEDERAL
AGENCIES AND OUR PARTNERS IN
PRIVATE SECTOR, ACADEMIA, AND
COMMUNITIES.
NEXT SLIDE PLEASE.
HERE IS WHERE OUR FUNDING GOES
IN TERMS OF BREAKDOWN INTO
DIFFERENT AREAS OF RESEARCH
FOCUS.
YOU'LL SEE OVER TIME AN
EXPANSION OF THE PRE-CLINICAL
AND TRANSLATIONAL RESEARCH IN
PAIN MANAGEMENT.
AND ONGOING EFFORTS IN ALL OF
THE DIFFERENT DOMAINS OF THE
HEAL INITIATIVE AS OUR BUDGET
HAS GROWN OVER TIME.
NEXT SLIDE PLEASE.
AND SOME OF OUR ONGOING
PRIORITIES THAT WE'VE DISCUSSED
WITH THIS GROUP IN THE PAST, AND
KEEP IN MIND FOR TODAY THE NEEDS
TO SET THE RIGHT BALANCE FOR
PAIN AND ADDICTION RESEARCH,
RECOGNIZING THAT THERE'S A LOT
OF OVERLAP BOTH OF THE MOLECULAR
LEVEL AND AT THE POPULATION
LEVEL.
FOCUS ON CO-OCCURRING CONDITIONS
BECAUSE NO ONE INTERVENTION IS
GOING TO BE STRONG ENOUGH TO
SOLVE EVERY HEALTH PROBLEM, AND
SO WE HAVE TO BE LOOKING AT THE
WHOLE PERSON AND CONSIDERING
THAT IN OUR RESEARCH.
RESEARCH FOCUSED ON STIGMA AND
INEQUITIES IN OUR HEALTH CARE
SYSTEM BEING REALISTIC IN THE
RESEARCH WE CONDUCT SO WE BEGIN
TO BREAK DOWN THOSE BARRIERS TO
HIGH-QUALITY CARE FOR ALL,
INTEGRATING VOICE OF LIVED
EXPERIENCE IS A REALLY IMPORTANT
TALL TOWARD THAT GOAL, BUT NOT
THE ONLY ONE.
WE'RE ALSO LEVERAGING THE POWER
OF THE DATA COMING OUT OF OUR
STUDIES, TO PROVIDE NEW LINES OF
INQUIRY AND BETTER UNDERSTAND
THE CONDITIONS WE'RE STUDYING,
AND OF COURSE TRAINING THE NEXT
GENERATION OF RESEARCHERS, YOU
HEARD FROM DR. KOROSHETZ, IT'S A
KEY TOOL FOR LONG TERM AND
SUSTAINABLE INITIATIVE TO
ADDRESS THESE CHALLENGES.
NEXT SLIDE PLEASE.
THIS IS OUR AGENDA.
WE'RE OVER TIME, AS YOU'LL SEE.
BUT I DO WANT TO MAKE SURE THAT
WE HAVE A MOMENT FOR DISCUSSION,
BOTH OF WHAT WE HEARD ABOUT FROM
THE PREVIOUS SPEAKERS AND ALSO
THE OVERVIEW I JUST PROVIDED.
WE'LL MAKE A FEW TWEAKS TO THE
AFTERNOON'S PROGRAM BUT THE KEY
QUESTION WILL BE ASKING HOW DO
THESE PROGRAMS FIT TOGETHER, HOW
DO THE NEW RESEARCH PROJECTS
THAT THE TEAMS HAVE COME
TOGETHER TO PROPOSE AND ADVANCE
THE OVERALL GOAL OF SCIENTIFIC
SOLUTIONS TO HELP BRING ABOUT AN
END TO THE OPIOID CRISIS,
INCLUDING STRATEGIES, TREATING
PAIN, ENHANCED OUTCOMES FOR
INFANTS EXPOSED TO OPIOIDS
DURING A MOTHER'S PREGNANCY.
I'LL NOW PAUSE AND INVITE
QUESTIONS FROM THE
MULTI-DISCIPLINARY WORKING GROUP
AND OTHERS ON THE CALL.
THANK YOU VERY MUCH FOR YOUR
ATTENTION.
>> I'LL START.
>> GO AHEAD.
>> VERY AMBITIOUS PORTFOLIO,
IT'S VERY EXCITING.
THERE ARE -- I THINK THAT YOU'VE
HIT ON ALL THE DIFFERENT AREAS,
EVERYONE HAS, WALTER'S
PRESENTATION, I THINK WE'RE
LOOKING FORWARD TO SEEING
RESULTS OF MORE OF THESE
STUDIES.
>> THANK YOU, GAIL.
GO AHEAD, ERIC.
>> THANKS.
I'M VERY IMPRESSED BY THIS
ENTIRE PORTFOLIO.
I HAD A QUESTION ABOUT THE
BACPAC INITIATIVE WITH RESPECT
TO THE CLINICAL TRIALS.
HOW ARE THE MECHANISTIC EFFORTS
IN THE OTHER STAGES AND PHASES
OF THE BACPAC PROGRAM BEING
ROLLED INTO THESE CLINICAL
TRIALS?
ARE WE GOING TO BE USING THE
METHODOLOGY -- IN PARTICULAR THE
NEUROSCIENTIFIC METHODOLOGIES
THAT ARE BEING PUSHED FORWARD IN
THE EARLIER FOUNDATIONAL STAGES
OF BACPAC INTO THESE CLINICAL
TRIALS?
>> YEAH, THANK YOU FOR THAT
QUESTION.
SO, I THINK YOU'RE TALKING IN
PARTICULAR ABOUT THE TECHNOLOGY
CENTERS THAT ARE IDENTIFYING AND
TESTING NEW TECHNOLOGIES.
WE HAVE TO UNDERSTAND FIRST
THEIR EFFECTIVENESS, EFFICACY,
BEFORE WE CAN INCORPORATE THEM
INTO FUTURE WORK WHICH I THINK
SPEAKS TO THE FACT THAT FOR US
TO FULLY BENEFIT FROM WHAT WE'RE
LEARNING IN THE FIRST PHASE
WE'LL CONTINUE TO FOCUS ON
TAKING TECHNOLOGIES AND APPLYING
THEM IN FUTURE STUDIES.
THAT I THINK IS PART OF THE
REASON WE SPENT SO MUCH TIME
FOCUSING ON THE INFRASTRUCTURE
AND ESTABLISHING DATA COLLECTION
METHODS, ET CETERA, SO THAT NOT
ONLY ARE WE HARMONIZING EFFORTS
IN THIS CURRENT PHASE BUT SO WE
CAN FULLY LEVERAGE AND INTEGRATE
FUTURE STUDIES WITH THE CURRENT
DATA.
SO, I HOPE THAT ADDRESSES TO
SOME EXTENT YOUR QUESTION.
WE FULLY INTEND TO CONTINUE WORK
IN THIS AREA BUT AS I MENTIONED
WE WANT TO MAKE SURE WE'RE ALSO
LEVERAGING NOT ONLY WHAT WE'RE
LEARNING THROUGH THE TECHNOLOGY
AND MECHANIC MECHANISTIC CENTET
REJOIN, MYOFASCIAL PAIN,
THINKING ABOUT THE LANDSCAPE TO
FORMULATE OUR PLANS MOVING
FORWARD.
>> THAT'S REALLY HELPFUL.
I GUESS I'M HOPING THAT THE DEEP
PHENOTYPING THAT'S HAPPENING AT
MULTIPLE BIOPSYCHOSOCIAL LEVELS
INCLUDING NEUROBIOLOGICAL LEVEL,
I'M HOPING THAT WE'LL SEE SOME
DEEP PHENOTYPING FOLLOWING THESE
VARIOUS INTERVENTION PACKAGES
AND TREATMENTS SO WE CAN SEE IF
THE MULTIVARIATE SIGNATURE OF
RESPONSIVENESS TO THIS
INTERVENTION, IF IT CHANGES
ACROSS THESE DEEP PHENOTYPES.
I THINK THAT WOULD BE REALLY
INTERESTING AND PUSH THE FIELD
FORWARD.
>> ABSOLUTELY.
I THINK THIS THEORETICAL MODEL
THAT I MENTIONED ACKNOWLEDGES OR
RECOGNIZES THE FACT THERE ARE SO
MANY DIMENSIONS TO THE PROBLEM,
WHY IT'S SO DIFFICULT TO TACKLE.
WITHOUT DATA WE CAN'T ANSWER
QUESTIONS, SO I DEGREE IT'S
IMPORTANT BUT THE
INDIVIDUALIZATION, SO HOW THESE
DIFFERENT PHENOTYPES CORRESPOND
OR RELATE TO DIFFERENT SUBGROUPS
OF PATIENTS IS GOING TO BE
REALLY IMPORTANT AND INFORMATIVE
SO WE CAN BE EFFICIENT MOVING
FORWARD.
>> THANK YOU.
WONDERFUL PROGRAM.
>> THANKS.
>> THANK YOU, ERIC.
OTHER QUESTIONS FOR THE GENERAL
DISCUSSION IN THE OPEN SESSION
OF TODAY'S MEETING?
>> A SMALL COMMENT.
IT WAS REALLY IMPRESSIVE.
IT MIGHT BE WORTH TELLING THE
PUBLIC THERE'S A BIG EFFORT NOW
TO LOOK AT THE, IF YOU WILL,
TRANSCRIPTOMES AND PROTEOMES IN
HUMAN TISSUE WITH THE HOPE IT
WILL SPEED UP DEVELOPMENT OF
THERAPIES SPECIFICALLY DIRECTED
AT HUMAN, CERTAINLY OBVIOUSLY I
ENDORSE THE ANIMAL MODELS BUT AT
SOME POINT WE'RE GOING TO
TRANSLATE IT.
>> THANK YOU.
YEAH, WE'LL THINK ABOUT WAYS TO
WORK TO COMMUNICATE THAT.
I AGREE IT'S SOMETHING WE'VE
BEEN WORKING ON IN "HEAL" AND
EVERYONE KNOWS.
OKAY.
I THINK IF THERE ARE NO
ADDITIONAL QUESTIONS WE CAN END
THE OPEN SESSION OF TODAY'S
HEALTH MULTI-DISCIPLINARY
WORKING GROUP MEETING