>> GOOD MORNING, EVERYONE.
AMY START OFF.
>> I'LL WELCOME YOU BACK TO THE
HEAL ENDING END ADDICTION LONG
TERM, MDWG.
THIS IS OPEN TO THE PUBLIC VIA
VIDEOCAST AND THE GROUP HAS THE
HEALTH CARE COMMUNITY AND
ADVOCATES RELATED TO PAIN AND
LOOKS AT ACTIVE AND PROPOSED
PROJECTS IN THE NIH HEAL
INITIATIVE AND SUGGESTS AREAS
WHERE MORE RESEARCH IS NEEDED
AND WE GREATLY APPRECIATE YOUR
INPUT.
I'M AMY BANY ADAMS FOR THE
INSTITUTE OF NEUROLOGICAL ORDERS
AND STROKE AND THE EXEC SEC FOR
THE MEETING AND HOPE TO KEEP
RUNNING IT SMOOTHLY.
WE'RE GRATEFUL FOR YOUR SERVICE
AND YOUR PERSPECTIVE HELPS
ENSURE WE LOOK INTO OVERDOSE AND
PAIN MANAGEMENT.
ALMOST EVERY NIH INSTITUTE AND
CENTER ACCELERATES RESEARCH TO
ADDRESS THIS PUBLIC HEALTH
EMERGENCY FROM ALL ANGLES AND 19
INSTITUTES AND CENTERS ARE
ENGAGED DIRECTLY IN THE HEAL
INITIATIVE.
TODAY YOU'LL HEAR PRESENTATIONS
IN THE OPEN AND CLOSED SESSIONS
FROM SOME OF THE FANTASTIC
INDIVIDUALS MANAGING HEAL
PROGRAMS FROM ACROSS THESE MANY
INSTITUTES AND CENTERS.
I WANT TO APPRECIATE THE WORK
THEY DO TO ADVANCE SCIENCE.
IT ALSO TAKES A VILLAGE TO PUT A
MEETING LIKE THIS TOGETHER AND I
WANT TO ACKNOWLEDGE THE WORK OF
PEOPLE BEHIND THE SCENES FOR
THEIR WORK TO PULL THIS
PARTICULAR MEETING TOGETHER.
I APPRECIATE YOUR EFFORTS TO
HAVE THIS ALL RUN SMOOTHLY AND I
WANT TO ALSO ACKNOWLEDGE WE'VE
HAD TECHNICAL AND I.T. ISSUES
LEADING UP TO THE MEETING AND I
APPRECIATE EVERYBODY'S
APPRECIATION AND WILLINGNESS TO
WORK THROUGH THEM.
FOR THE MDWG MEMBERS YOU CAN
RAISE YOUR HAND OR PUT YOUR
QUESTION IN THE CHAT OR SAY YOU
HAVE A QUESTION OR COMMENT IN
THE CHAT AND WE'LL BE SURE
YOU'RE CALLED ON AT THE
APPROPRIATE MOMENT.
SO WITH THAT, I WANT TO
RECOGNIZE MDWG CO-CHAIR
DR. WALTER KOROSHETZ AND THE
WELCOME YOU AND PROVIDE
HEAL/PAIN UPDATES.
WALTER.
>> THANK YOU, DR. ADAMS.
I WANT TO THANK EVERYBODY COMING
ON TODAY.
THE HEAL PROGRAM IS THE MOST
EXCITING THING I'VE SEEN IN MY
LIFE AND WORKING WITH NIDA TO
ADDRESS EVERYONE WITH MORE
URGENCY.
THE MDWG IS A GREAT GROUP THAT'S
BEEN ABLE TO KEEP US CENTERED ON
THE IMPORTANT THINGS GOING
FORWARD.
HOPEFULLY YOU LEARN AND GET A
SENSE OF WHAT WE'RE DOING FROM
THE DISCUSSIONS HERE TODAY AND
WE REALLY VALUE YOUR INPUT.
THAT'S WHAT THE MDWG IS ALL
ABOUT.
WE WORK HARD WITHIN THE BELTWAY
BUT THE EYES ON WHAT WE'RE DOING
MAKES THIS MORE VALUABLE.
WE NEED YOUR THOUGHTS AND TAKE
THEM SERIOUSLY.
I'LL START OFF BY TALKING ABOUT
HOW HEAL IS ADDRESSING PAIN AND
AN UPDATE ON WHAT WE'RE DOING
THERE AND CARLOS BLANCO IS GOING
TO GIVE US A STATE OF THE OPIOID
CRISIS AND NORA UNFORTUNATELY
WAS UNABLE TO BE HERE TODAY AND
CARLOS IS TREMENDOUSLY
KNOWLEDGEABLE IN THIS PLACE AND
GRATEFUL TO HAVE DR. CRISWELL A
CO-CHAIR FOR THE PAIN INITIATIVE
HEAL SIDE TO TALK ABOUT HER
VISION FOR PAIN RESEARCH FROM
OUR VANTAGE POINT AS THE NIAMS
DIRECTOR.
AS WE'VE TOLD YOU IN THE PAST
THE HEAL/PAIN PORTFOLIO NOW IS
PUT TOGETHER VERY DEMOCRATICALLY
BY 15 DIFFERENT INSTITUTES.
THEY HAVE THEIR DIRECTORS AROUND
THE TABLE AND THEY'RE THE FINAL
DECIDERS ON WHAT WE FUND AND OUR
PLANS GOING FORWARD.
THERE'S THINGS GOING ON BEFORE
THINGS REACH THE DIRECTORS,
DR. CRISWELL AND LANGEVIN
COORDINATE TO MAKE DECISIONS AND
BEFORE THAT WE HAVE A SMALL
STAFF GROUP LOOKING AT THE DAY
TO DAY ACTIVITIES OF HEAL AND
HAVE A STEERING COMMITTEE MADE
UP OF REPRESENTATIVES FROM THE
INSTITUTES AND EACH OF THEIR
REPRESENTATIVES HAS ONE VOTE IN
THE STEERING COMMITTEE AND THEY
PRIORITIZE THE RESEARCH COMING
FORWARD AND THE INITIATIVES
GOING FORWARD WHICH THEN COME
FROM A SERIES OF WORKING GROUP
MADE UP OF PROGRAM DIRECTORS
THROUGHOUT THE 14 INSTITUTE --
15 INSTITUTES AND CENTERS.
WOE HAVE A DYNAMIC SET UP WE
ENGAGE ACROSS NIH IN THE HEAL.
THIS IS SOMETHING WE NEED FOR
PAIN BECAUSE WE DON'T HAVE THE
EQUIVALENT OF NIDA THE INSTITUTE
FOR DRUG ABUSE BUT THE HEAL
GROUP IS SERVING IN A SIMILAR
CAPACITY FOR PAIN RESEARCH.
THIS IS TO SHOW YOU WHAT OUR
BUDGETARY SITUATION IS NOW.
DIFFERENT COLORS REPRESENT
DIFFERENT FUNDING COMMITMENTS.
THE KEY THING TO KNOW IS THE
CIRCLES AT THE END YOU SEE THE
DOLLARS AVAILABLE FOR NEW
RESEARCH GOING FORWARD.
AND THE TAKE HOME POINT IS THAT
THE PROJECTS WE PUT TOGETHER
OVER THE LAST COUPLE YEARS AS
OUR FUNDINGS INCREASE ARE NOW
OUT THERE.
THE WORK IS BEING DONE BUT
WITHOUT INCREASES IN FUNDING
FROM CONGRESS THERE WILL BE NEW
MONEY TO THE PROJECT END AND THE
MONEY RETURNS BACK.
PRIMARILY IN 2027 AND
THEREAFTER.
THAT'S GOOD TIMING TALKING ABOUT
STRATEGIC PLANNING GOING ON NOW
AND THROUGH 2025 WE CAN PUT UP
CONCEPTS IN 2026 AND IN 2027 THE
FUNDING LOOSENS UP NEW PROJECTS.
JUST WANTED TO SHOW HERE THE
FUNDING THAT IS AVAILABLE
THROUGH THE HEAL INITIATIVE
APPROPRIATIONS FROM CONGRESS.
MONEY COMES FROM NINDS USED TO
FUND THE PROJECTS THE RC
DIRECTORS ALL AGREE UPON AND
CURRENTLY HAVE $285 MILLION A
YEAR.
A SUBSTANTIAL NUMBER.
AND NIDA HAS CURRENTLY $355.3
MILLION A YEAR.
MORE ON THE OUD THAN PAIN SIDE
BUT STILL SUBSTANTIAL ON THE
PAIN SIDE AND THE HOUSE BUDGET
FOR '25, OF COURSE WE DON'T KNOW
WHAT '25 WILL BRING US.
WE DON'T EXPECT A BUDGET UNTIL
AFTER THE ELECTION AND MAYBE
DEPENDING ON THE ELECTION COULD
BE EARLY SPRING BUT THE HOUSE
BUDGET THE SAME $285 MILLION THE
SENATE BUDGET WAS CHANGED AND
MORE BY THE SENATE.
SO THOSE ARE THE NUMBERS THAT
WE'RE PLANNING ON GOING FORWARD
AND FOR US IN THE PAIN SPACE YOU
HAVE TO ERROR ON THE SIDE OF
TAKING THE $285.3 MILLION BUT
CERTAINLY BECAUSE OF THE SMALL
AMOUNTS AVAILABLE TO NEW FUNDING
WE CERTAINLY CAN DO GREAT THINGS
AS NEW FUNDS BECOME AVAILABLE IN
'25.
WITH THIS FUNDING WE HAVE
PROGRAMS THAT STRETCH ACROSS
THIS PLAN TO GO FROM THE
DISCOVERIES MADE IN THE BIO TECH
OR ACADEMIC SPACE, TO BRING
THOSE DISCOVERIES TO HEALTH,
REDUCE THE SUFFERING DUE TO PAIN
THROUGH CLINICAL TRIALS AND
WORKING THROUGH IMPLEMENTATION
AND DISSEMINATION RESEARCH.
SOME OF THIS IS DEVELOPMENT OF
NON-ADDICTIVE THERAPEUTICS THAT
ARE HOPEFULLY GOING TO BE MORE
EFFECTIVE OR EQUALLY EFFECTIVE
SO THEY CAN SUBSTITUTE FOR
OPIOIDS BUT A GREAT DEAL IS ALSO
FOCUSSED ON UNDERSTANDING PAIN
MECHANISMS THAT REALLY WERE
UNABLE TO BE ATTACKED WITHOUT
GETTING ALL THE I.C.s TOGETHER
TO WORK ON THEM AND BACPAC IS A
GOOD EXAMPLE.
THEN WE HAVE A NUMBER OF
CLINICAL PROGRAMS TESTING
AVAILABLE STRATEGIES TO IMPROVE
PAIN CARE PARTICULARLY THOSE
WHICH HELP TO BE MORE EFFECTIVE
AND REDUCE THE RISK OF
ADDICTION.
SOME VERY ROBUST PROGRAMS GOING
ACROSS THE IDEA THERE'S NO
BOTTLENECK THAT PRESENTS A GOOD
IDEA BEING FROM TESTED UP TO
HELPING PATIENTS.
THE NEXT SLIDE SHOWS THE BROAD
RANGE OF SCIENCE THAT WE FUND.
SO, WE HAVE CLINICAL,
TRANSLATIONAL AND BASIC AS YOU
CAN SEE HERE AND THE CLINICAL I
THINK IS THE LARGEST BUCKET.
WE ALSO SERVE IN THE
TRANSLATIONAL SPACE BUCK THE
BOTTLES WITH THE LACK OF
INTEREST FROM THE PHARMACEUTICAL
COMPANIES ON THERAPEUTICS TO
MAKE THE DISCOVERIES THAT COME
OUT OF THE LABS AT LEAST GET TO
THE SMALL BIOTECH SPACE TO GET
TO AN IND STAGE THAT I THINK
WOULD BRING IN THE BIGGER
INDUSTRY FOLKS TO GO IN THE MORE
EXPENSIVE PHASE III TRIALS.
WE'RE ALSO PUTTING A SIGNIFICANT
AMOUNT OF EFFORT INTO TRAINING.
WE THINK THAT WILL BE A LEGACY
OF HEAL BUILDING A WORKFORCE OF
PEOPLE KNOWLEDGEABLE ABOUT PAIN
EXPLOSION IN DISCOVERY IN PAIN
MECHANISMS.
DID IT INCREASE THE AMOUNT OF
PAIN RESEARCH BEING DONE BY THE
INSTITUTES THEMSELVES.
THE QUESTION BEING ARE THE
INSTITUTES GIVING UP ON PAIN AND
SAYING LET HEAL DO IT AND THE
ANSWER IS NO.
THE AMOUNT OF FUNDING FOR PAIN
RESEARCH IS GOING ON AT THE
INSTITUTES HAS ONLY INCREASED
SINCE HEAL STARTED.
YOU CAN SEE HEAL IS IMPORTANT
BUT ONLY A MINORITY AROUND 15%
TO 20% OF THE TOTAL PAIN FUNDING
AT NIH.
IT DOES HAVE A SPECIAL ROLE OF
MOVING THINGS TOWARDS PATIENTS
AND TRANSLATION, TOWARDS TESTING
NEW STRATEGIES IN PATIENTS AND
ALSO AS I MENTIONED
INVESTIGATING IMPORTANT BASIC
MECHANISMS THAT CAN'T BE DONE BY
ANY SINGLE INSTITUTE.
I'LL NOT TALK ABOUT THE
INTERAGENCY COORDINATING
COMMITTEE HELENE SHOULD TALK
ABOUT BECAUSE SHE'S THE CHAIR.
IF I MAKE A MISTAKE JUST GIVE ME
A NUDGE.
FOR HISTORY STAKE THE HHS
SECRETARY IN 2010 THERE WAS A
REPORT THAT CAME OUT IN 2011 AND
MOTIVATED THE DEVELOPMENT OF THE
INTERAGENCY PAIN COORDINATING
COMMITTEE A COMMITTEE THAT
REPORTS TO HHS AND THEY HAVE
DONE SUPERB WORK OVER THE YEARS
RIGHT FROM THE BEGINNING THEY
WORKED HARD ON A NATIONAL PAIN
STRATEGY AND FEDERAL PAIN
RESEARCH STRATEGY WHICH IS IF
YOU HAVEN'T READ IT, IT'S WORTH
READING.
I DON'T SAY THAT A LOT ABOUT A
LOT OF FEDERAL DOCUMENTS BUT IT
POINTS OUT IN PAIN RESEARCH AND
IT HAS INFLUENCED WHAT WE'VE
DONE IN HEAL.
THE IPRCC IS BRINGING IN NEW
MEMBERS AND ESTABLISHED WORKING
GROUPS TO LOOK TO HOW WE BETTER
TAKE DEEP DIVES TO ADVANCED PAIN
RESEARCH AND CARE AND LOOKING AT
A LANDSCAPE OF EDUCATIONAL
CRITERIA AND RESOURCES FOR PAIN
TRAINING.
IN COLLABORATION WITH UNIVERSITY
OF MICHIGAN THEY'RE USING
MACHINE LEARNING TECHNIQUE TO
LOOKING AT PAIN GRAPHS AND
MATCHING THEM TO THE FEDERAL
PAIN RESEARCH STRATEGY
PRIORITIES TO HELP IN THE HEAL
STRATEGIC PLANNING AND MANY HAVE
BEEN DEVELOPED AND PAIN RESEARCH
NETWORK AND WE HAVEN'T FINISHED.
WE HAVE WORK TO DO.
UNDERSTAND PLASTICITY MECHANISM
AND WORKING ON PERSISTENT PAIN.
I THINK HELENE MENTIONED MANY
TIMES WE HAVE TO STOP THINKING
ABOUT THE RESOLUTION SIDE AND
SUSTAIN WITHOUT CHRONIC PAIN AND
DEVELOP SAFER OPIOIDS.
WE'RE WORKING HARD ON DEVELOPING
NEW NON-OPIOID ANALGESIC AND
UNDERSTAND COMORBIDITIES AND
CHRONIC PAIN, A VERY DIFFICULT
PROBLEM, APPROACHES TO PRECISION
MEDICINE TO EFFECTIVELY TREAT
CHRONIC PAIN AND LOOK AT
SUSCEPTIBILITY AND RESILIENCY
FACTORS A LOT IN THAT SPACE AND
MECHANISTIC TRIALS OF RISK AND
RESILIENCE TO CHRONIC PAIN,
DEVELOPING OPTIMAL SAFE AND
CHRONIC PAIN MANAGEMENT
STRATEGIES, TRYING TO IMPROVE
MODELS OF PAIN CARE IN HEALTH
CARE SYSTEMS AND OPTIMAL
APPROACHES FOR MANAGEMENT OF
PAIN AND AT THE BOTTOM IT'S
UNFORTUNATE IT'S AT THE BOTTOM
AND WE'RE MAKING A BIG STRIDE TO
WORK IN PAIN WITH THE KIDS PAIN
HEAL PROGRAM.
SOMETHING THAT WE SHOULD I'M A
LITTLE ASHAMED IT'S AT THE
BOTTOM BUT WE'LL BE APPROACHING
IT NOW WITH THE KIDS PAIN
PROGRAM OUT OF NICHP.
JUST A COUPLE INTERESTING POINTS
TO MAKE ABOUT WHAT'S GONE ON.
THERE WAS THE INTERNATIONAL
WORLD CONGRESS OF PAIN TOOK
PLACE IN THE NETHERLANDS AND
THERE WAS AN INTERESTING SET OF
TAUKSZ BY JANE BALLANTINE AND
ALLAN BASBAUM AND LEARNED ABOUT
THE DIFFERENCE OF THE TWO SIDES
AND ALLAN, YOU'RE BOTH RIGHT.
HELENE GAVE A GREAT TALK ABOUT
WHOLE PERSON PERSPECTIVES AND
THAT WAS GREAT TO SEE AT AN
INTERNATIONAL MEETING AND A
STRATEGIC PLANNING UPDATE.
WE MENTIONED WE'RE BEGINNING OUR
WORK TO DEVELOP A HEAL PAIN
STRATEGIC PLAN AND GRATEFUL TO
CO-CHAIRS AND WE HAVE A NUMBER
OF MEMBERS OF THE WORKING GROUP
WHO ARE WORKING TOGETHER IN THE
AREAS OF PAIN AND AND DOING DEEP
DIVES IN PARTICULAR AREAS.
LIVED EXPERIENCE AND HEALTH
EQUITY AND NON-ADDICTIVE
THERAPEUTIC DEVELOPMENT AND
OPTIMIZATION OF INTERVENTION TO
REDUCE PAIN AND PAIN BIOMARKERS
AND PREDICTORS AND SUBSTANCE USE
DISORDER, PAIN RESEARCH AND
COURSE IN TRAINING AND
IMPLEMENTATION OF HEALTH
SERVICES.
THERE'S A LOT TO COVER.
A LOT OF THINGS THAT GO ACROSS
THE DIFFERENT GROUPS AND WE'RE
ALWAYS INTERESTED TO GET TO
THINGS THAT ARE IMPORTANT THESE
GROUPS CAN THEN ADDRESS AS THEY
DEVELOP A STRATEGIC PLAN AND
THANKS TO JACKIE WARD FOR DIRECT
BEING AND LEADING THIS GROUP AND
LOOKING FORWARD TO THEIR WORK.
THE WORK GROUPS AND ALSO THE
MEETINGS THAT THEY WOULD BE
HOLDING TOGETHER INPUT FROM THE
COMMUNITY.
I WANTED TO SHOUT OUT TO THE
RESEARCH PRIORITIES THAT CAME
OUT OF THE GROUP, THIS IS NOT
NIH FUNDED THOUGH MICHAEL
OSHINSKY WAS IN THE GROUP AND
IT'S A NICE MODEL TO LOOK AT.
THEY DID A GOOD JOB AT KIND OF
GIVING A COMPREHENSIVE LOOK AT
WHAT THE RESEARCH PRIORITIES ARE
AND THE HEADACHE SPACE AND WE
CONTINUE TO KEEP PLUGGING THESE
PEOPLE AND TELLING THEM THEY'RE
WELCOME IN THE HEAL COMMUNITY.
A COUPLE ADVANCES I WANTED TO
THROW OUT.
I PROBABLY TALKED AD NAUSEAM
ABOUT THE TECHNOLOGY COMING OUT
AND HOW THEY ARE AT MODULATING
CIRCUITS BUT THIS CAME OUT FROM
A GROUP CLEVERLY DESIGNED AN
EXPERIMENTAL MODEL OF PLACEBO
EFFECT.
ONE CAN LOOK AT THE MODEL AND
THEY'RE NOT THE SAME AS WHAT
HUMANS EXPERIENCE AS PLACEBO
EFFECT BUT HAS DEFINITE
SIMILARITIES AND IT AFFECTED THE
BEHAVIOR OF THE ANIMALS AND
RESPONSE TO PAINFUL STIMULUS.
THERE'S A PLACEBO ANALGESIC AND
THEY'LL FIND THAT THIS WAS A
CIRCUIT SET UP IN THE ANTERIOR
CINGULATE CORTEX AND YOU CAN NOW
FIND OUT WHERE IT'S SENDING THE
INPUTS TO AND IT WAS SENDING IT
TO A NUCLEUS IN THE PONS AND
GOING TO THE SIR BELL -- --
CEREBELLUM AND WE HAVE A CIRCUIT
AMENABLE TOE MANIPULATION
HOPEFULLY TO GET ANALGESIA THAT
DRIVES OFF THE NATURAL PLACEBO
RESPONSE THAT I'M SURE IS THERE
FOR A REASON.
COOL THING IS IT PICKED UP AREAS
IN THE BRAIN NO ONE HAS EVER
EXPECTED HAD TO DO WITH PLACEBO
RESPONSE AND THE CEREBELLUM AND
THE NUCLEUS WAS NOT KNOWN TO BE
A PAIN CIRCUIT.
HEAVY RECEPTORS IN THE PONS AND
NUCLEUS AND THIS AFFECT THE
PLACEBO A LOT BY NALOXONE.
IT'S AN OPIOID RECEPTOR ISSUE
THAT USES THE RECEPTORS TO HELP
TREAT PAIN.
NEXT SLIDE IS AN INTERESTING
LOOK AT PERIPHERAL
SENSITIZATION.
WHAT WAS FOUND LOOKING AT HUMAN
FEMALES VERSUS MALES AND
CORRELATED WITH HUMAN TRG TISSUE
THAT WAS INVESTIGATED AND
PROLACTIN HAS RESPONSE IN THE
DORSAL ROOT GANGLION CAUSING
INCREASED FIRING AND NO RESPONSE
AT ALL IN THE MALES.
SO VERY INTERESTING DICHOTOMY
THERE.
THERE WAS A SIMILAR DICHOTOMY
WITH AREXIN IT CAUSED
STIMULATION IN THE MALES BUT NOT
FEMALES.
SO GETTING AT THESE SEX AT BIRTH
EFFECTS MEDIATED BY THESE
HORMONES COMING OUT OF THE
HYPOTHALAMUS IMPORTANT TO
UNDERSTAND POTENTIALLY A GOOD
WAY OF DEVELOPING NON-ADDICTIVE
PAIN THERAPEUTICS.
FINALLY, I WANTED TO LOOK AT A
GROUP AND PEOPLE KNOW WHEN
SENSITIZATION OCCURS AND THE
PAIN SYSTEM PERIPHERALLY IS MORE
RESPONSIVE TO A PAINFUL STIMULUS
THAN NORMAL IT OCCURS BECAUSE
STIMULATION SETS UP PROTEIN
SYNTHESIS AND THIS IS HEAVILY
RELIANT UPON THE PRODUCTION OF
IL6 DURING THAT PAIN STIMULUS
AND THIS GROUP WAS ABLE TO SHOW
THE IL6 IS WORKING THROUGH A
PARTICULAR PATHWAY AGAIN NAILING
DOWN WHICH COULD BE A PATHWAY TO
DEVELOP NON-ADDICTIVE
THERAPEUTICS GOING FORWARD BY
BLOCKING SPECIFICALLY THIS
PATHWAY WHICH LEADS TO THE
INCREASED SENSITIZATION
PERIPHERALLY.
I WANT TO END BY SAY ANYTHING IN
TERMS OF THE HUMAN TISSUE, WORK
IS REALLY GOING QUITE WELL.
IT WAS SOMETHING I WAS QUITE
SURPRISED WE COULD PULL OFF.
AS I MENTIONED FROM THE PREVIOUS
COUPLE SLIDES ABOUT HOW VALUABLE
HAVING THIS HUMAN DRG TISSUE IS
AND OUR NETWORK AND U-19 CENTERS
BRING HUMAN TISSUE INTO THE HEAL
NETWORK FOR STUDYING PAIN IS
REALLY WORKING.
AND THE HEAL THERAPEUTIC
DEVELOPMENT PROGRAM ALSO A
NUMBER OF SUCCESSES WITH TWO
INDs FILED THIS YEAR AND ONE IS
LICENSE FROM DANA FARBER THE
PROGRAM TO START FROM WHAT THE
ASSET IS TO MOVE THROUGH THE
STAGES TO GET THE IND.
WE HAVE ANOTHER CLINICAL TRIALS
STARTED FOUR OR FIVE YEARS AGO
WHICH I THINK THE RESULTS ARE
GOING TO HAVE A BIG EFFECT ON
THE TREATMENT OF PAIN IN THE
COMMUNITY AND WE'RE LOOKING
FORWARD TO RESULTS.
SOME ARE CLOSE TO FINISHING
ENROLLMENT IS KEEP YOUR EYES OUT
FOR THE PAPERS COMING OUT AND
LOOKING FORWARD TO THE STUDIES
AND WE NEED TO START UP A WHOLE
NEW SET OF CLINICAL TRIALS AS
THESE COME TO AN END.
IN TERMS OF THE NEW NOFOs WITH
COORDINATING HEALTH CARE SYSTEMS
AND THIS IS CENTRAL TO OUR
SUCCESS TRYING TO DO THE
RESEARCH THAT WILL INFLUENCE AND
TAKE UP BETTER PAIN MANAGEMENT
TO HEALTH CARE SYSTEMS BECAUSE
THEY SEE IT PROVIDES BETTER
OUTCOMES FOR THEIR PATIENTS AND
HOPEFULLY THEY CAN SEE IT'S
WORTH THE INVESTMENT.
MAY SAVE THE MONEY IN SOME
INSTANCES IF THEY HAVE A MUCH
MORE SYSTEMATIC APPROACH TO PAIN
IN THE HEALTH CARE SYSTEMS.
AND NEW FUNDING OPPORTUNITIES IN
THE TRAINING SPACE.
I MENTION THE HEAL KIDS PROGRAM
IS OUT THERE TO BE LAUNCHED AND
ALSO AN INTERACTIVE BACK PAIN
TEAM IS OUT THERE THE NEW HEAL
FUNDING OPPORTUNITIES.
AND WITH THAT, I WANT TO THANK
YOU.
THAT'S THE REPORT FROM THE PAIN
SIDE.
DO WE HAVE TIME FOR QUESTIONS?
>> I THINK WE SHOULD MOVE OVER
AND WE'LL HAVE TIME FOR
DISCUSSION AFTER.
>> VERY GOOD.
CARLOS, WOULD YOU LIKE TO --
>> LINDSEY'S NEXT.
>> SORRY.
>> ACTUALLY, I'LL BE SHARING MY
SLIDES SO IF YOU GUYS CAN STOP
SHARING.
CAN YOU SEE MY SLIDES OKAY?
>> YES.
>> GREAT.
>> AND CAMERA OKAY?
>> YES.
>> ALL RIGHT, THANK YOU VERY
MUCH.
IT'S A PLEASURE TO BE TO BE
MEETING WITH YOU ALL TODAY AND
TALK ABOUT NIAMS' VISION FOR
PAIN RESEARCH.
THANK YOU, WALTER FOR THE GREAT
OVERVIEW OF WHERE WE ARE IN
HEAL.
NIAMS IS VERY SUPPORTIVE AND
GRATEFUL.
I'LL COVER FOUR AREAS.
A BRIEF REMINDER OF NIAMS' ROLE
IN THE HEAL ECO SPHERE AND
PROGRAMS SUPPORTED BY NIAMS,
ADVANCEMENT IN RELEVANT PROGRAMS
RELATED TO PAIN AND WHAT WE'RE
ENVISIONING FOR THE FUTURE OF
PAIN RESEARCH.
SO WITHIN THE BROAD HEAL
INITIATIVE NIAMS IS FOCUSSED IN
RESEARCH IN CHRONIC PAIN.
PAIN IS AN IMPORTANT TOPIC IN
MANY DISEASES WITH OUR MISSION.
NIAMS SUPPORTS THE PAIN
CONSORTIUM FINDING THE
INNERVATION OF TISSUES BY
SENSORY NEURONS THAT MEDIATE THE
SENSATION OF PAIN AND SUPPORTING
THE BACK PAIN CONSORTIUM YOU'RE
PROBABLY FAMILIAR WITH TO
DISCOVER THE MECHANISMS OF
CHRONIC LOW BACK PAIN AND
IDENTIFY AND TEST NEW TARGETED
INTERVENTIONS.
THESE ARE TWO EXAMPLES HOW IT
BROUGHT TOGETHER INSTITUTES AND
CENTERS TO TACKLE CHRONIC PAIN.
SO MORE SPECIFICALLY THE REJOIN
CONSORTIUM AIMS TO UNDERSTAND
HOW SENSORY PATTERN NETWORKS
CHANGE WITH DISEASE AND AGING.
FIVE PROJECTS WERE AWARDED IN
2023 TOTALLING ABOUT $31 MILLION
AND FOCUSSING ON INNERVATION
MAPPING AND MAPPING WITHIN
ANIMALS AND HUMANS.
REJOIN IS HARMONIZING DATA
COLLECTION ACROSS THE SITES AND
STUDY MODELS AND BROADLY SHARING
RESEARCH METHODS ACROSS TRE
CONSORTIUM.
THESE RESEARCH TEAMS HAVE
ALREADY DEVELOPED EXCITING NOVEL
APPROACHES TO THREE DIMENSIONAL
MAPPING OF JOINT INTERVENTION
SUCH AS MICROSCOPY AND THE
TRANSCRIPTION OF PROFILES OF
CELLS THAT PLAY A ROLE IN JOINT
PAIN CONDITIONS AND WAS IN THE
PREPRINT STAGE.
BACKPACK HAS 13 AWARDS TOTALLING
APPROXIMATELY $131 MILLION.
AT THE BASIC RESEARCH LEVEL,
BACKPACK HAS DEVELOPED AN
INTEGRATIVE MODEL OF BACK PAIN
BASED ON IMPROVED UNDERSTANDING
OF MECHANISMS.
THIS MODEL IS CONTINUING TO BE
REFINED AND SHOULD NEED TO NEW
THERAPIES.
AT THE TRANSLATIONAL LEVEL
BACKPACK HAS NEW THERAPIES INTO
MULTI-MODAL INTERVENTIONS
CREATING COHORTS WITH DEEP
PHENOTYPING AND CREATING
ALGORITHMS TO MATCH EACH PAYMENT
TO THE BEST TREATMENT BASED ON
THEIR SPECIFIC PHENOTYPE AND
PSYCHOSOCIAL CONTEXT.
WE ARE VERY PLEASED WITH THE
PROGRESS OF BACKPACK INCLUDING
THE RECENT PRODUCTION OF A LARGE
PUBLICATION PACKAGE AT THE END
OF LAST YEAR THAT OUTLINES
GOALS, STRUCTURES AND AR
MONIZATION EFFORTS WITHIN THE
CONSORTIUM INCLUDING IN
PREPARATION OF HEAL DATA
ELEMENTS.
AND ANALYZING LARGE AMOUNTS OF
DATA AND ALL STUDIES ARE FULLY
ENROLLED OR COMPLETING.
INVESTIGATORS ARE LEARNING HOW
TO LEVERAGE NEW TECHNOLOGIES
WITH DATA COLLECTED TO UNCOVER
RELATIONSHIPS BETWEEN BIO
MECHANICS AND OTHER METRICS USED
TO CHARACTERIZE LOW BACK PAIN.
AND THERE'S BIOMARKERS FOR
EVALUATING SPINE TREATMENTS OR
THE BEST TRIAL.
THIS FOUR-ARMED TRIAL IS DESIGN
TO ESTIMATE AN ALGORITHM TO
ASSIGN THE SEQUENCE OF TWO
TREATMENTS FOR BACK PAIN BASED
ON A PATIENT'S PHENOTYPIC
MARKERS.
THIS EXPLORED FOUR INTERVENTIONS
THAT HAVE ALL SHOWN SOME
EFFECTIVENESS FOR CHRONIC LOW
BACK PAIN AND ENHANCED BACK PAIR
AND ACCEPTANCE AND COMMITMENT
THERAPY, EVIDENCE BASED EXERCISE
AND THERAPY AND DULOXETINE AND
IS LOOKING AT WHICH IS BEST FOR
EACH PATIENT VERSUS AVERAGE
EFFECT.
AND FOLLOWING THE ASSIGNMENT
RANDOMIZED TRIAL OR SMART
DESIGN, ALL PARTICIPANTS ARE
INITIALLY RANDOMIZED TO ONE OF
THE FOUR TREATMENTS FOR THE
FIRST PERIOD.
THE TREATMENT DURING THE SECOND
PERIOD DEPENDS ON THEIR RESPONSE
TO THE INITIAL TREATMENT.
FOR EXAMPLE, IF THE FIRST
TREATMENT IS IMPROVING PAIN AND
QUALITY OF LIFE THEN IT'S
MAINTAINED DURING THE SECOND
TREATMENT PERIOD.
IF THE TREATMENT IS IMPROVING
PAIN BUT NOT OVER ALL QUALITY OF
LIFE IT'S AUGMENTED WITH THE
SECOND TREATMENT.
IF THE TREATMENT APPEARS TO HAVE
NO EFFECT, THEN THE PARTICIPANT
IS RANDOMIZED TO HAVE A SECOND
TREATMENT EITHER ADDED TO OR
REPLACING THE FIRST TREATMENT
AND THEN IF THE TREATMENT IS
MAKING PAIN WORSE, THAT
TREATMENT IS DISCONTINUED AND
REPLACED BY A NEW TREATMENT.
SO THE TRIAL IS NOW FULLY
ENROLLED AND NEARLY COMPLETE
WITH ONLY A HANDFUL OF THE 24
VISITS THE PRIMARY END POINT.
AS YOU MAY KNOW THERE ARE
SEVERAL UPCOMING OR RECENTLY
ANNOUNCED NEW PROGRAMS SUCH AS
HEAL INTERACT AND WE'RE
DELIGHTED TO BE LEADING THIS
NOTICE OF FUNDING OPPORTUNITY OR
NOFO THAT AIMS TO BUILD UPON THE
ORIGINAL PHASE AND CONTINUE THE
DIAGNOSIS AND TREATMENT OF
CHRONIC LOW BACK PAIN AND THE
TEAMS WILL DEVELOP INTEGRATIVE
MODELS FOR UNDERSTANDING
MULTI-DIMENSIONAL,
MULTI-MODALITY DATA AND ANALYSES
OF THE INTERRELATIONSHIPS WEN
THE VARIOUS DATA TYPES.
THEY WILL ALSO INFORM THE
STRUCTURE AND KEY ELEMENTS OF
FUTURE FEDERATED EFFORTS FOR
MUSCULOSKELETAL PAIN EFFORTS.
ONE OF OUR OVER ARCHING GOALS.
APPLICATIONS WILL BE DUE IN
OCTOBER.
WALTER ALSO MENTIONED TOO OUR
VERY IMPORTANT EFFORTS IN
PEDIATRIC PAIN.
SO WE'RE BUILDING UPON THE HEAL
KIDS ACUTE PAIN CLINICAL TRIALS
WITH THE NEW HEAL KIDS CHRONIC
PAIN PROGRAM AONCE NOED IN THE
NOFO LAST MONTH.
WE LOOK FORWARD TO FUNDING
PROGRAMS THAT WILL ENHANCE AND
EXPAND OUR CAPACITY TO PURSUE
THERAPEUTICS DEVELOPMENT AND
EFFECTIVE MANAGEMENT OF CHRONIC
PEDIATRIC PAIN CONDITIONS.
WE EXPECT THE INTERDISCIPLINARY
TEAMS WILL COMBINE CLINICAL
RESEARCH WITH CUTTING EDGE
TECHNOLOGIES AND MEASUREMENT
SCIENCE IN THE COLLABORATIVE AND
INTEGRATIVE WAY.
WE'RE VERY EXCITED ABOUT THIS
PROGRAM.
ALSO ON THE HORIZON, NIAMS IS
PARTICIPATING IN THE PAIN CARE
CLINICIAN TRAINING PROGRAM
ANNOUNCED RECENTLY IN A NOFO
THIS PAST JUNE BY SUPPORTING THE
CAREER DEVELOPMENT OF
INDIVIDUALS WITH CLINICAL
DOCTORAL DEGREES.
THIS K23 AWARD IS DESIGNED
SPECIFICALLY FOR APPLICANTS
PROPOSING TO SERVE AS THE LEAD
INVESTIGATOR OF AN INDEPENDENT
CLINICAL TRIAL, A CLINICAL TRIAL
FEASIBILITY STUDY OR SEPARATE
ANCILLARY CLINICAL TRIAL AS PART
OF THEIR OWN CAREER DEVELOPMENT
ACTIVITIES.
SIMILARLY NIAMS SIGNED CALLING
FOR PARTNERSHIP TO ADVANCE
INTERDISCIPLINARY TRAINING IN
CLINICAL PAIN RESEARCH
SUPPORTING T90, R90
INSTITUTIONAL POSTDOCTORAL
TRAINING TO PROMOTE THE NEXT
GENERATION OF INDEPENDENT
CLINICAL RESEARCHERS.
EACH T90, R90 PROGRAM IS
REQUIRED TO PROPOSE A
PARTNERSHIP BETWEEN TWO OR MORE
DEPARTMENTS OR COLLEGES WITHIN A
SINGLE INSTITUTION.
THIS IS NOW CLOSED AND NIH
EXPECTS TO FUND UP TO FOUR
AWARDS DEPENDING ON THE OUTCOME
OF THE REVIEW PANEL.
I WANT TO BRIEFLY HIGHLIGHT
THANKS TO A BUDGET INCREASE FOR
FISCAL 2023, NIAMS WAS ABLE TO
PUBLISH TWO NOTICES OF SPECIAL
INTEREST OR NOSI IN RHEUMATIC
SKIN AND MUSCULOSKELETAL
DISEASES AND ONE WAS TO EXPAND
OR ADD THE RESEARCH ON PAIN AS
IT RELATE TO THE TOPIC OF THE
ORIGINAL APPLICATION AND WE
FUNDED 18 SUPPLEMENTS UNDER THIS
EFFORT.
THE SECOND ONE ULTIMATELY
ENABLED FIVE OF THE T32 TRAINING
PROGRAMS TO PRIORITIZE
UNDERSTANDING THE MECHANISMS,
MEASUREMENT OR TREATMENT OF
PAIN.
NOW, IN RELATION TO PAIN
RESEARCH OSTEOARTHRITIS PRESENCE
A CHALLENGE WITH THE KNEE JOINT
DEGENERATION AND IMPORTANT IS
ADDRESSING PAIN IS THE OF THEO
ARTHRITIS INITIATIVE WHICH IS
DEVELOPED FROM A PUBLIC-PRIVATE
PARTNERSHIP BACK IN 2001.
IT'S ONE OFF THE LARGEST AND
MOST IMPORTANT DATA SETS IN THE
HISTORY OF RESEARCH AND DATA AND
SPECIMENS AND X-RAY AND IMAGES
FROM APPROXIMATELY 4800
PARTICIPANTS WHO EITHER HAD OR
WERE AT HIGH RISK OF DEVELOPING
OAI.
AND ALL THE PARTICIPANT VISITS
THROUGH EIGHT YEARS OF FOLLOW UP
WERE COMPLETED BACK IN 2015.
THE DATA HAS BEEN AND CONTINUED
TO BE FREELY AVAILABLE AT
OAI.NIH.gov AND CAN BE STUDIED
FOR RISK FACTORS FOR EARLY ONSET
AND PROGRESSION AND THE DATA ARE
ALSO A DATA RESOURCE TO APPLY
BIG DATA METHODS TO BIOMEDICAL
RESEARCH.
TO DATE THERE'S BEEN OVER 700
PEER-REVIEWED PAPERS PUBLISHED
WITH THE DATA AND WE'RE EXCITED
TO BE CONTINUING TO SUPPORT THIS
EFFORT THROUGH OUR NOSI.
ON THAT NOTE, THIS NOSI INTENDED
TO FURTHER LEVERAGE THIS
VALUABLE RESOURCE WAS A NIAMS
AND NIA PARTNERSHIP AND INTENDS
TO USE THE RICH DATABASE AS WELL
AS THE CLINICAL DATA AND IMAGES.
WHILE THE RESOURCE HAS BEEN
WIDELY USED AND ACCESSED BY OAI
INVESTIGATORS LOOKING AT
BIOBEHAVIORAL AND OTHER
PHARMACOLOGIC INTERVENTIONS IN
RESPONSE TO OAI
A AND HAPPY THE RESOURCED CAN BE
AVAILABLE TO OTHER INVESTIGATORS
AND ALSO IT CAN SERVE AS A
TRAINING VEHICLE FOR FUTURE
MUSCULOSKELETAL AND PAIN
RESEARCHERS.
SO I WANT TO TAKE A MOMENT TO
DESCRIBE OUR VISION FOR THE
RESEARCH BOTH INSIDE AND OUTSIDE
OF HEAL.
MAINTAINING A WHOLE PERSON
APPROACH AND DEVELOP IN THE
IMPLEMENTATION PROCESSES,
PROMOTING INTERDISCIPLINARY TEAM
SCIENCE IN THE AREA OF PAIN,
ENHANCING OUR DATA
INFRASTRUCTURE AND HARMONIZATION
EFFORTS AND INTEGRATING THE HEAL
PROGRAMS INTO A COMPREHENSIVE
MUSCULOSKELETAL PAIN RESEARCH
NETWORK.
SO AS I MENTIONED, WE HAVE BEEN
PRIORITIZING PAIN RESEARCH WITH
A VISION OF A WHOLE PERSON
APPROACH WHICH ACKNOWLEDGES THAT
PAIN CAN EFFECT EACH PERSON AND
THEIR DAILY LIFE DIFFERENTLY
DEPENDING ON DIFFERENT FACTORS.
ONE EXAMPLE OF A WHOLE PERSON
APPROACH CAN BE FOUND IN THE
BACKPACK PROGRAM WHERE
RESEARCHERS ARE INVESTIGATING
HEALTH INEQUITIES IN THE
MANAGEMENT OF BACK PAIN AND HOW
SOCIAL DETERMINATES OF HEALTH
AND COMORBIDITIES SHAPE A
PERSON'S EXPERIENCE OF PAIN.
PEOPLE WITH LIVED AND LIVING
EXPERIENCES OF CHRONIC PAIN ARE
ALSO INVOLVED THROUGHOUT THE
ENTIRE RESEARCH PROCESS HELPING
TO PLAN A STUDY, IMPLEMENT IT
AND MAKE SURE IT'S CULTURALLY
RELEVANT TO THE INDIVIDUALS
FAMILIES AND COMMUNITIES IT'S
DESIGN TO HELP.
ANOTHER EXAMPLE OF OUR WHOLE
PERSON APPROACH CAN BE SEEN IN
THE REJOIN CONSORTIUM.
AS I REMINDER, THE REJOIN
CONSORTIUM IS SEEKING TO
UNDERSTAND JOINT PAIN AT THE
MOLECULAR LEVEL IDENTIFYING NEW
TARGETS FOR INTERVENTION AND
SEEKS TO UNDERSTAND HOW JOINT
PAIN OCCURS DIFFERENTLY ACROSS
VARIOUS DISEASES AND HOW IT'S
EFFECTED BY AGE AND SEX, FOR
EXAMPLE, WHICH CAN INFORM MORE
PRECISE THERAPEUTIC
INTERVENTIONS.
A LARGE GAP IN PAIN RESEARCH
NIAMS IS TRYING TO ADDRESS IN
HEAL IS UNDERSTANDING THE
DRIVERS OF PAIN AT THE MOLECULAR
AND TISSUE LEVEL AT THE SAME
TIME UNDERSTANDING PAIN
EXPERIENCE OF THE LEVEL OF THE
PERSON.
SO TO ADDRESS THIS CHALLENGE,
NIAMS IS FOCUSSED ON
COLLABORATIVE TEAM SCIENCE
APPROACH TO GENERATE MODELS OF
PAIN.
LISTED ARE EXAMPLES OF SUCH
COLLABORATIVE ACTIVITIES THAT
ARE UNDERWAY THROUGH OUR
INVOLVEMENT OF HEAL, MANY OF
WHICH I TOUCHED ON INCLUDING
PAIN COLLECTION AND PROTOCOLS,
ASSEMBLING WORKING GROUPS AND
DEVELOP A THEORETICAL MODEL OF
CHRONIC LOW BACK PAIN AND TRIALS
LIKE THE BEST TRIAL FROM THE
BACPAC PROGRAM AND INTEGRATING
DATA FROM TEAMS CREATING 3-D
MAPS OF THE SENSORY NEURONS
FOUND IN THE KNEES AND TEMPORO
MANDIBULAR JOINTS AND
INTEGRATING THE COLLECTION OF
EFFORTS AND ACCELERATE THE DATA
AVAILABLE TO RESEARCHERS AND
HEALTH CARE PROVIDERS, COMMUNITY
LEADERS, POLICY MAKERS AND OTHER
PARTNERS TO BENEFIT FROM
LEARNING OF RESULTS OF THE
INITIATIVE.
IT ALLOWS USERS TO ACCESS
FINDINGS FROM DIFFERENT STUDIES
WHICH CAN BE ANALYZED TO COMPARE
AND COMBINE AND THIS TOOL
ENABLES RESEARCHERS TO FOLLOW
THEIR PRINCIPLE MAKING THEIR
HEAL-GENERATED DATA FINDABLE,
INTEROPERABLE AND INTERUSABLE
AND THE INITIATIVE HAS DEVELOPED
THE HEAL SOMANTIC RESEARCH WHICH
IS MEANT TO BE A TOOL TO THE
DATA PLATFORM AND THE SEARCH
TOOL HELPS USERS FIND COMMON
DATA ELEMENTS, RELEVANT HEAL
STUDIES AND VARIABLES RELATED TO
THE SEARCH TERMS AND SEARCH
RESULTS OF INTEREST.
I'M HIGHLIGHTING THE EFFORTS
BECAUSE WE APPRECIATE THE VALUE
THIS IS BRINGING TO THE ENTIRE
NETWORK OF HEAL INVESTIGATORS
AND PROJECTS.
ALONG THOSE LINES THIS
ILLUSTRATES EXAMPLES OF DATA
TYPES AND THE ECO SYSTEM AND
NOFO ARE EFFORTS TO LEAD TOWARDS
THE VISION TO BRING PROGRAMS IN
CLOSER ALIGNMENT FOR A LARGER
MORE INTEGRATED APPROACH TO
MUSCULOSKELETAL PAIN.
OUR INTENT IS TO FACILITATE
INTEGRATION OF METHODOLOGIES AND
INTERVENTIONS AND COLLABORATIVE
PROJECTS TO ACCELERATE KNOWLEDGE
TRANSFER.
ON THAT NOTE I WANT TO THANK ALL
THE RESEARCHERS THAT HAVE
PARTICIPATED IN THE PROGRAMS
INCLUDING THE BACPAC ADVISORY
BOARD MEMBERS AND PROGRAM STAFF
PARTICULARLY THOSE AT HEAL WHO
HAVE BEEN SO HELPFUL IN TERMS OF
MANAGING SOME OF THE AWARDS.
I WANT TO ACKNOWLEDGE ALL THE
PATIENTS PARTICIPATING IN THE
EFFORTS AND ALL OF YOU, OUR
ADVISERS ON THE WORKING GROUP.
THANK YOU SO MUCH FOR THE TIME
TO PRESENT OUR INTEREST IN PAIN
RESEARCH AT NIAMS.
>> WE'LL GO TO DR. CARLOS BLANCO
AND HE'LL BE STANDING IN TO GIVE
AN UPDATE ON THE STATE OF THE
OPIOID CRISIS.
>> I HOPE TO ECHO WHAT LINDSAY
WAS SAYING AND THANK YOU FOR
BEING GIVING ADVICE ON HOW TO DO
THIS AND GENERATE NEW IDEAS.
LET ME START WITH SOME GOOD
NEWS.
FOR THE FIRST TIME WE CAN REPORT
A DECREASE IN DEATHS.
YOU CAN SEE THE PROVISIONAL
INFORMATION HAS SEEN A DECREASE
ACROSS ALL SUBSTANCES.
TO THE THIS IS GOOD NEWS IT
WOULD BE NAIVE TO THINK WE'RE AT
AND THE OF THE EPIDEMIC.
STILL PRELIMINARY AND EARLY BUT
WE HAVE SOME GOOD NEWS.
AND THERE'S AN INDICATION THOUGH
THE WORK PUT INTO THIS ARE
EFFORTS AND I EXPECT THIS TO BE
UPS AND DOWNS BUT HOPEFULLY THE
LINE IS TRENDING DOWN.
I WANTED TO START WITH THIS GOOD
NEWS AND THANK YOU FOR THE
EFFORTS YOU'VE MADE AND PUT INTO
HELPING US BUILD AND CONTINUE
WITH HEAL.
THE DRIVERS OF THE EPIDEMIC ARE
TOO EARLY TO KNOW.
IT'S BEEN ACROSS THE BOARD BUT
STILL TOO EARLY TO KNOW WHAT'S
GOING TO CHANGE.
IT LOOKS LIKE IT'S TRENDING DOWN
WHICH WOULD BE GREAT NEWS.
WE HAVE TO SEE THE OTHER TRENDS
IN THE SAME DIRECTION BUT AGAIN
GOOD NEWS.
AND SOME ARE STILL TRENDING UP
BUT THE BIG RISK GROUPS REMAIN
THE SAME BY AGE AND RACE AND
ETHNICITY.
AMERICAN INDIANS AND ALASKAN
NATIVES AND BLACKS ARE THE
GROUPS THAT CONTINUE TO BE
MOSTLY HURT BY THE OVERDOSE
EPIDEMIC.
ONE OF THE MAIN ISSUES WE HAVE
IN THE OPIATE CRISIS AND ACROSS
MEDICINE IS DEVELOPING EFFECTIVE
INTERVENTIONS AND THEY'RE VASTLY
UNDER UTILIZED AND DON'T REACH
EVERYBODY THEY COULD BENEFIT.
SO ONE OF THE EFFORTS WE ARE
PUTTING AT NIDA IS NOT ONLY
DEVELOPING NEW INTERVENTIONS BUT
MAKING SURE THE INTERVENTIONS
REACH EVERYBODY ESPECIALLY THOSE
MORE UNDER SERVED AND DON'T GET
OFTEN THE BENEFIT OF THE
INTERVENTIONS.
I WANTED TO ABOUT THE NEEDS FOR
THE OPIATE EPIDEMIC AND CRISIS
IS THREE BUCKETS.
WE NEED BETTER DATA.
ONE OF THE EFFORTS WE'RE MAKING
AND I ALWAYS THINK ABOUT IT
LATER IS GENERATE BEING BETTER
METHODS AND BETTER WAYS OF
GETTING DATA.
THE SECOND ASPECT IS PREVENTING
OVERDOSES AND DEVELOPING A
SUBSTANCE USE DISORDER ACROSS
THE LIFE SPAN.
THOUGH MOST THE EFFORTS WE HAVE
PUT IN TOWARDS TREATMENT, IT IS
CLEAR BECAUSE MOST PEOPLE DON'T
SEEK TREATMENT BECAUSE TREATMENT
IS NOT GOING TO BE ENOUGH.
SO ONE OF THE THINGS WE HAVE
EMPHASIZED IS THE DEVELOPMENT
AND IMPLEMENTATION OF PREVENTING
INTERVENTIONS AND THE THIRD
BUCKET TAKING MOST THE EFFORT OF
HIM IS DEVELOPING OF
INTERVENTIONS AND ONE OF THE
THINGS WE HAVE VTRIED TO DO IS
TRYING TO TAILOR THE
INTERVENTIONS WE HAVE TO THE
NEEDS AND PREFERENCES OF
DIFFERENT GROUPS OF PATIENTS OR
INDIVIDUALS.
SO GOING BACK TO THE ISSUE OF
THE DATA, THOUGH WE TALK ABOUT
THE OPIATE EPIDEMIC OR OVERDOSE
CRISIS YOU HAVE TO RECOGNIZE
THIS IS NOT ONLY ONE CRISIS, IT
IS REALLY A COMBINATION OF
CRISIS HETEROGENEITY IN THE
GROUPS AFFECTED, HETEROGENEITY
IN THE ACCESS TO TREATMENT OR
RECOVERING FROM TREATMENT OR
HARM REDUCTION INTERVENTIONS.
I'LL BE TALKING ABOUT THAT
BRIEFLY IN MY PRESENTATION.
THIS IS AN EXAMPLE OF THIS AND
SOME PROGRAMS WE HAVE DEVELOPED
ARE PREVENTING INTERVENTIONS.
THE HARM REDUCTION INTERVENTIONS
AND IMPROVING DELIVERY FOR POLY
SUBSTANCE USE.
AS WE KNOW THOUGH WE TALK ABOUT
OPIOIDS OR METHAMPHETAMINE, S
STIMULANTS AND MANY HAVE A
COMBINATION IT'S RARE THERE'S
ONLY ONE DISORDER AND WE NEED TO
ADDRESS THE COMBINATION OF
DISORDERS AND NEED TO UNDERSTAND
THE NATURE OF POLY SUBSTANCE USE
AND INTERVENTIONS THAT COULD BE
USED FOR A VARIETY OF PATIENTS.
AND WE RECENTLY STARTED THE
NATIVE COLLECTIVE EFFORT TO
ENHANCE WELLNESS TO COVER
SUBSTANCE USE AND PAIN.
LET ME START WITH PREVENTION AS
I WAS MENTIONING BEFORE.
30% OF INDIVIDUALS WITH
SUBSTANCE USE DISORDERS SEEK
TREATMENT.
IT'S POSSIBLE TO SOLVE THE
OPIATE CRISIS BY TREATMENT.
WE NEED TO PUT MORE EMPHASIS ON
PREVENTION.
THE EMPHASIS IS TWO REASONS.
ONE IT'S CERTAINLY BETTER THAN
TRYING TO SOLVE THEM AND WE WANT
AS NIH NOT ONLY TO CURE PEOPLE
BUT REALLY PROMOTE THE HEALTH
AND POTENTIAL OF INDIVIDUALS.
WE WORK TO AVOID THE PROBLEM AND
HELP THEM IN ANY WAY WE CAN.
SO PREVENTION IS REALLY WHAT CAN
HELP.
WHEN PEOPLE COME TO TREATMENT,
THEY ALREADY HAVE SOME SEQUELAE
FROM SUBSTANCE USE DISORDER.
SO PREVENTION IS KEY.
I'M VERY GRATEFUL THAT AMY
GOLDSTEIN AND HER TEAM HAVE
DEVELOPED A PROGRAM OF
PREVENTION AND HAVE SORT OF
IDENTIFIED FOUR AREAS THAT
REQUIRE ATTENTION.
ONE IS RISK IDENTIFICATION SO WE
KNOW THE DRIVERS THAT PUT PEOPLE
AT RISK FOR SUBSTANCE USE
DISORDERS AND CAN STRATIFY
POPULATIONS AT DIFFERENT LEVELS
OF RISK AND INTERVENTION
DEVELOPMENTS THOUGH WE HAVE GOOD
INTERVENTIONS WE NEED BETTER
ONES AND HETEROGENEITY OF
POPULATIONS SO WE NEED
INTERVENTIONS TAILORED FOR THE
NEEDS OF EACH GROUP AND THEN WE
HAVE TO INTERVENE AT THE SOCIAL
DETERMINATES OF RISK AND WE LIVE
IN DIFFERENT COMMUNITIES AND
NEIGHBORHOODS AND WE'RE
INFLUENCED BY THE ENVIRONMENT IN
WHICH WE LIVE NOT ONLY
INDIVIDUAL RISK LEVEL SO THAT'S
WHY WE ALSO DEVELOP INTERVE
INTERVENTIONS AT AND THOSE
INTERVENTIONS HAVE NOT ALWAYS
TAKEN UP OR SCALED UP OR USED
EQUITABLY.
WE'RE DEVELOPING THE
INTERVENTION AND MAKING SURE
THEY REACH EVERYBODY THAT COULD
BENEFIT FROM THOSE
INTERVENTIONS.
THIS IS JUST A SAMPLE OF THE
INTERVENTIONS THAT ARE BEING
DEVELOPED.
WE'RE ABOUT TO FINISH MOST THE
PROJECTS.
HOPEFULLY IN THE NEXT YEAR OR
TWO WE'LL HAVE OUTCOME DATA
WE'LL BE ABLE TO REPORT BUT AS
YOU CAN SEE IT'S A GOOD
INTERVENTION.
SOME AT THE SCHOOL LEVEL, SOME
TARGETING COMORBIDITIES AFTER
DISORDERS LIKE ADHD AND WE'RE
TRYING TO SORT OF DIVERSIFY
INVESTMENTS TRYING TO LOOK INTO
DIFFERENT AREAS, DIFFERENT
SETTINGS AND POPULATIONS TO SEE
WAYS AND LEARN FROM OUR
MISTAKES.
SOME INVESTMENTS ARE NOT GOING
TO WORK OUT AND WANT TO LEARN
WHAT WE NEED TO CHANGE AND
MODIFY TO MAKE PREVENTION MORE
EFFECTIVE.
IN ADDITION TO THE WAYS OF
DISSEMINATING INFORMATION AND
PUBLISHING PAPERS IN HIGH IMPACT
JOURNALS WE DISSEMINATE THROUGH
OTHER CHANNELS.
WE ENCOURAGE P.I.s AND
AUTHORITIES TO DISSEMINATE
INFORMATION IN LETTERS,
WEBINARS, OP-EDs.
WE WANT TO TAKE A FULL APPROACH
TO NOT ONLY GENERATING THE
INFORMATION BUT MAKING SURE THE
INFORMATION REACHES ALL RELEVANT
AND STAKEHOLDERS AND THEY CAN
GIVE IMPACT ON HOW TO DO THINGS
BETTER THE NEXT TIME.
ON THE ISSUES OF SERVICES I
MENTIONED BEFORE IS THE
INTERVENTIONS DON'T ALWAYS REACH
THE INTENDED TARGETS.
ONE OF THE STUDIES WE ARE DOING
IS UNDERSTANDING FROM WHAT IS IN
CHARGE OF PREVENTION OF THE
NETWORKS STAND UP THE
INTERVENTION AND SUSTAIN THE
INTERVENTIONS.
ONE THING WE ALSO LEARNED AND
I'M SURE YOU'VE HAD SIMILAR
EXPERIENCES IS AN INTERVENTION
IS SUSTAINABLE WITH THE GRANT
FUNDING BUT ONCE IT DISAPPEARS
THE INTERVENTIONS HAVE NOT
SUSTAIN AND TRYING TO WORK WITH
STATE DEPARTMENTS OF HEALTH AND
MAKE SURE THE INTERVENTIONS WE
DEVELOP ARE SUSTAINABLE AND CAN
BE SUPPORTED BY OTHER SOURCES OF
FUNDING LIKE SAMHSA OR STATE
DEPARTMENTS OR OTHER FOUNDATION
MONEY TO SUSTAIN THE
INTERVENTIONS.
AND ALSO RELATED TO THE SLIDE
YOU MAY WANT TO KNOW AS SOME
ALREADY KNOW I.C.s HAVE AN ALL
RIGHT ON HOW TO DEVELOP
INFRASTRUCTURE FOR BEHAVIORAL
DISORDER.
MANY OF THE THINGS WE'RE DOING
BENEFIT FROM THE RECOMMENDATION
OF THE REPORT AND HOPEFULLY
THROUGH THE INFRASTRUCTURE WE
CREATED TO PROVIDE PREVENTIVE
INTERVENTIONS THROUGHOUT THE
NATION.
ONE OF THE INITIATIVES WE HAVE
DEVELOPED RECENTLY IS HEAL DATA
COLLECTION AND THE GOAL OF THE
INITIATIVE IS REALLY THE
COMBINED PROGRAM BEING AND DATA
THAT CAN THEN INFORM SPECIFIC
INTERVENT
INTERVENTIONS WE HAVE PROJECTS
AND A MODELLING CENTER AND
INFRASTRUCTURE CENTER AND
SUPPORT CENTER BECAUSE WE KNOW
EVEN THOUGH WE CAN DEVELOP THE
INTERVENTIONS IT TAKES EFFORTS
AND SCIENCE AND CERTAIN SKILLS
TO MAKE SURE THE INTERVENTIONS
ARE LIMITED.
THIS IS AN EXAMPLE OF THE
PROJECTS WE'RE FUNDING, SURGERY,
LINKAGES, HOW TO DO BETTER AND
INTEREST IN TELEHEALTH AND ALSO
DOING NOT ONLY COLLECTING DATA
BUT DOING MODELLING BECAUSE WE
NEED TO RELY ALSO ON SIMULATIONS
AND MODELLING TO SEE WHAT MIGHT
WORK IN DIFFERENT SETTINGS.
IN ADDITION TO INDIVIDUAL
PROJECT WE HAVE SUPPORT CENTERS
THAT CAN HELP COORDINATE AND
ENHANCE THE EFFECT OF THE
INDIVIDUAL PROJECTS.
AND DISSEMINATION OF THE
KNOWLEDGE CREATED.
AND HOPEFULLY THIS WILL COMBINE
THE BEST OF TWO WORLDS.
I ALSO WANTED TO MENTION JCOIN
ONE OF THE STAR PROGRAMS OF HEAL
AND IT'S A LEARNING SYSTEM OF
CARE THAT COMBINES SCIENTISTS,
RESEARCHERS FROM THE SUBSTANCE
USE FIELD AND SEE THE PROTOCOLS,
MORE THAN 22,000 INDIVIDUALS
YENL ROLLED, PILOT GRANTS, IT'S
BEEN ALSO USEFUL TO TRAIN THEM
AND GENERATE ACTIVITY THIS IS A
MODEL PROGRAM IN MY OPINION AND
GENERATED OPPORTUNITIES FOR
CAPACITY AS I SAID NOT ONLY WITH
THE YOUNGER GENERATION AND
GENERATING COURSES THAT CAN BE
ACCESSED FOR PEOPLE TO LEARN
TECHNICAL ASSISTANCE HAS BEEN
USEFUL IN INCORPORATING
KNOWLEDGE AND A FANTASTIC
PROGRAM.
AND PRACTICE AND POLICY IMPACTS
WHICH FOR US WAS IMPORTANT.
YOU CAN SEE THEM LISTED HERE.
WE HAVE WE ARE GOING TO PUT MORE
EMPHASIS ON INNOVATION AND
EMPHASIS ON THE ECONOMIC AND
RESEARCH CENTER BECAUSE ONE OF
THE THINGS THAT INTERFERES WITH
IMPLEMENTATION IS THE COST OF
THE INTERVENTIONS.
BY BEING ABLE TO MODEL AND GIVE
TOOLS TO INCORPORATE
INTERVENTIONS WE HOPE IT WILL
HAVE MORE IMPACT AND HELP MANY
SETTINGS TO MANY OF THE
INTERVENTIONS WE'RE DEVELOPING.
EVEN THOUGH WE WANT PEOPLE TO
ACCESS SYSTEMS NOT EVERYBODY IS
READY TO ACCESS THE SYSTEMS.
WE DEVELOPED OTHER WAYS AND ONE
THING WE THINK IS INNOVATIVE IS
RECOVERY SUPPORT SYSTEMS.
WE WANT TO UNDERSTAND HOW PEOPLE
RECOVER AND WHAT HAD ARE THE
SUPPORTS THEY NEED SUPPORT
RESEARCH INITIATIVE WHICH IS
STUDYING PEER-RECOVERING CENTER
S AND OTHER WAYS TO SUPPORT
INDIVIDUALS WHO DO NOT SEEK
TREATMENT IN TRADITIONAL
SETTINGS LIKE PRIMARY CARE.
AND THEY HAVE CREATED THEIR OWN
CONSORTIUM ON ADDICTION RECOVERY
AND ALSO THE NATIONAL CONFERENCE
AND ARE BEING EXTREMELY ACTIVE.
WE'RE VERY EXCITED ABOUT THE
INITIATIVE AND WE THINK IT CAN
IMPACT A LOT OF PEOPLE WHO
OTHERWISE WOULD NOT ACCESS
SERVICES FOR RECOVERY AND TO
HELP RECOVER FROM SUBSTANCE USE
DISORDERS.
I'LL BE MOVING FASTER BECAUSE I
KNOW I'M RUNNING OUT OF TIME AND
RECOVERY SUPPORT AND IN ADDITION
TO SUPPORT, AS YOU KNOW, SOME
INDIVIDUALS ARE NOT READY OR NOT
WILLING AT THIS POINT IN STOMP
USING DRUGS.
IT DOES NOT MEAN THEY CANNOT
BENEFIT FROM OTHER INTERVENTION.
ONE THING WE DEVELOPED IS A
RESEARCH PROGRAM OR HARM
REDUCTION WHICH WE CALL THE HARM
REDUCTION RESEARCH NETWORK.
THE GOAL OF THAT IS TO
UNDERSTAND SOME OF THE PRACTICES
THAT ARE HAPPENING RIGHT NOW.
PROVIDING SPACE TO COLLABORATE
AND DEVELOP NEW IDEAS AND
ULTIMATELY PREVENT OVERDOSES AND
SAVE LIVES.
WE FUNDED 10 RO1s AND YOU CAN
SEE IN THE SLIDE WE ARE TRYING
OR STUDYING A NUMBER OF THINGS
SOME HARM REDUCTION APPROACHES
AND OVERDOSE PREVENTION CENTERS
AND WE'RE ALSO TRYING LOOK AT
MANAGEMENT AND ONE OF THE ISSUES
IN CONTINGENCY MANAGEMENT IS
THERE'S LEGAL ISSUES NOT WITH
STUDYING RESEARCH BUT SCALING IT
UP IN PRACTICE BECAUSE OF
REGULATIONS HHS HAS.
AND STUDYING THE EMERGENCY
DEPARTMENT AND UNDERSTANDING
BARRIERS FOR HARM REDUCTION AND
FACILITATING THOSE
INTERVENTIONS.
AND ONE OF THE INITIATIVE WE
HAVE NOW IS PUT INTO.
WE'RE MOVING AWAY FROM SPECIFIC
RFAs THAT DON'T ALLOW FOR
RESUBMISSION TO FURTHER RFAs
THAT ALLOW FOR TOPICS LIKELY TO
BE IMPORTANT IN THE NEAR FUTURE
AND GIVE FLEXIBILITY TO THE
INVESTIGATORS AND APPLICANT AND
RESUBMIT AND BETTER TAILOR THE
APPLICATIONS AND GIVES
FLEXIBILITY TO PUBLISH NOSIS AND
POINT OUT AREAS THAT ARE OF
INTEREST OR AREAS WHERE WE THINK
WE HAVE ENOUGH INFORMATION THAT
ARE ALREADY MATURE AND IT'S
BETTER TO PUT THE RESOURCES IN
OTHER AREAS.
AND IT WILL ALLOW FOR SUBMISSION
AND THE ABILITY FOR APPLICANTS
TO REVISE POLICY APPLICATIONS AN
ULTIMATELY FUND BETTER SCIENCE
LEADING TO BETTER POPULATION
HEALTH.
WITH THAT I WANT TO THANK YOU
FOR YOUR ATTENTION AND GIVE THE
FLOOR I THINK TO AMY AND
HOPEFULLY WE CAN HAVE SOME
DISCUSSION AND INPUT TO IMPROVE
WHAT WE ARE DOING.
THANKS VERY MUCH.
I'LL OPEN THE FLOOR TO ANY
PRESENTATIONS WE HEARD THIS
MORNING.
>> THANK YOU FOR WONDERFUL
PRESENTATIONS AND DR. BLANCO
THANK YOU FOR THE GOOD NEWS.
AND DR. CRISWELL THINKING ABOUT
THE EPISODE OF CARE ACROSS
PROVIDERS THAT A PATIENT MIGHT
TRAVERSE.
I'M WONDERING HOW TO ENSURE THE
PROGRAM PENETRATE DOWN TO THE
PROVIDERS WITH THE PATIENTS WE
COME IN CONTACT WITH.
NOT JUST THE PHYSICIAN AND BUT
ALSO THE NURSE BECAUSE THERE'S
WORK THAT SHOWS THAT PATIENTS
GET DIFFERENT MESSAGES FROM
PROVIDERS AND THEREFORE THAT
CONTRIBUTES TO THEIR DISABILITY
PARTICULARLY TO THE CONTEXT OF
LOW BACK PAIN AND IT IT'S
INFORMED AND THE SECOND THING IS
WHEN PATIENTS ARE IN PAIN, WE
ALSO KNOW THEY'LL SEEK FROM
WHENEVER CAN PROVIDE AND THERE'S
GOOD DATA TO SHOW OUT OF POCKET
EXPENSES PATIENTS WILL GO
THROUGH TO SEEKING CARE BECAUSE
INSURANCE COMPANIES WON'T PAY
FOR THINGS I'M THINKING MORE
OUTSIDE THE TRADITIONAL MEDICAL
MODELS.
MAYBE MASSAGE THERAPISTS AND
SOME STATES IS CHIROPRACTIC CARE
AND HOW TO PENETRATE TO REACH
THOSE PROVIDERS AS WELL.
>> YOU NICELY SUMMARIZED WHY
IT'S AN IMPORTANT CHALLENGING
AND COMPLEX ISSUE.
I KNOW SEEING PATIENTS WITH
CHRONIC PAIN HOW FRAGMENTED AND
INEFFECTUAL PAIN MANAGEMENT HAS
BEEN MANY YEARS.
IT'S RECOGNITION OF THE
CHALLENGES AND IMPORTANCE OF THE
PROBLEM THAT WE ARE FULLY
SUPPORTING THE INITIATIVE.
I'M NOT LEADING THIS INITIATIVE.
I'M HOPING ONE OF MY COLLEAGUES
AROUND THE TABLE WHOSE BEEN MORE
DEEPLY INVOLVED IN THE PLANNING
STAGES CAN SPEAK TO THAT AND
WALTER, I'M NOT SURE AMY, DO WE
HAVE SOMEONE ON TO DIVE INTO
MORE DETAILS HOW WE'LL DEAL WITH
THE BIG CHALLENGES?
I CAN PROBABLY HELP.
THEY'RE WORKING WITH LAURA AND I
HOPE IF ELIZABETH WANTS TO ADD
ANYTHING, PLEASE DO.
I THINK YOU'VE IDENTIFIED A WAY
BIGGER PROBLEM THAN THIS
INITIATIVE CAN ADDRESS.
IT DOES HOWEVER, INCLUDE THE
T90, R90.
THE UNIQUE PART ABOUT THIS IS
THAT IT INCLUDES REQUIRED TO
INCLUDE AREAS OF PAIN NOT
NECESSARILY HAPPENING IN PAIN
RESEARCH IN WHAT WE TYPICALLY
THINK OF.
IT'S EITHER ANESTHESIOLOGY ONLY
OR NEUROLOGY ONLY.
THEY'RE REQUIRED TO HAVE TWO
DISCIPLINES INCLUDED.
.
WHEN WE LOOK ACROSS PROGRAMS
BEING FUNDED THERE'S A BREADTH
OF DISCIPLINES.
IT'S GOING ACROSS DISCIPLINES
BUT DOESN'T GO UP AND DOWN WHERE
DOES THE PATIENT GO FROM SEEING
THEIR PHYSICAL THERAPIST
INITIALLY OR ETCETERA UP AND
DOWN.
THESE ARE COHORT TRAINING
PROGRAMS SO SIX PEOPLE OR FIVE
PEOPLE COME IN AT ONCE AND STAY
TOGETHER.
SO THERE ARE SEVERAL TRAINING
OPPORTUNITIES FOR THEM.
IT'S TIED IN WITH THE NATIONAL
K12 INITIATIVE WITH SPECIAL
TRAINING PROGRAMS AND OUR
PURPOSE NETWORK WITH SPECIAL
TRAINING PROGRAMS.
WE CAN TALK TO PURPOSE OR K12S
THEY ARE WORK THROUGH THEIR
RESOURCES FOR TRAINING AND SEE
IF THIS IS SOMETHING THEY SCAN
START TO THINK ABOUT BUT IT'S
NOT YET REALLY BUILT INTO THE
PROGRAM.
SO ELIZABETH, I SEE YOUR CAMERA
ON.
WOULD YOU LIKE TO ADD
>> WIRE HOPING TO TARGET NURSES
AND INDIVIDUALS WITH
NON-STANDARD BACKGROUNDS AND
THEN ALONG WITH THE PURPOSE
NETWORK WE'LL MAKE THE TRAINING
MATERIALS PUBLIC AND NOT JUST
AVAILABLE FOR MEMBERS OF THE
COHORT BUT SPREAD THEM AND SHARE
THAT WHILE WE'RE NOT AIMING TO
ESTABLISH A STANDARD ACROSS THE
FIELD I THINK IT'S AN
OPPORTUNITY TO START HAVING
CONVERSATIONS AND IT'S A PLACE
WHERE WE CAN HAVE DISCUSSIONS.
THANK YOU.
>> I THINK IT'S WORTH BRINGING
TO THE TABLE TO TAKE THE POINT
OF VIEW AND PENETRATE THE
WORKFORCE MORE DEEPLY.
IT'S AN IDEA TO CONSIDER.
>> WE'RE INTERESTED IN THE
PATIENT PERSPECTIVE.
>> I THINK WHAT YOU'RE ALLUDING
TO IT'S IMPORTANT THE PROVIDERS
OF INTERVENTIONS THESE TYPES OF
PROVIDERS --
>> CAN YOU TALK LOUDER?
>> I'M SORRY.
THESE TYPE OF PROVIDERS NEED TO
PARTICIPATE IN RESEARCH AND NEED
TO BE PART OF THE TEAM THAT
DESIGN THE CLINICAL PROTOCOLS.
SO THE TYPES OF PROVIDERS
SOMETIMES A LOT OF THEM ARE
CLINICIAN, THEY CAN HAVE SOME
TRAINING IN RESEARCH BUT NOT A
LOT.
IT'S A CHALLENGE FOR THEM TO DO
THAT AND BECOME RESEARCHERS AND
TO BE SUCCESSFUL.
SO ONE OF THE THINGS WE'RE DOING
AT NCCIA WE RECENTLY LAUNCHED A
RESOURCE CENTER A VIRTUAL
RESOURCE CENTER THAT
PARTICULARLY SUPPORTS THE
SCHOOLS OF FOR EXAMPLE
CHIROPRACTIC SCHOOL SO HELP THEM
AND ASSIST THEM IN READING FOR
EXAMPLE FUNDING OPPORTUNITIES.
WRITING A GRANT APPLICATION,
FIGURING OUT LOGISTIC AL DETAIL,
ADMINISTRATIVE SUPPORT.
THOSE TYPES OF PROVIDERS HAVE A
HARD TIME AND THE TYPE OF
RESOURCE WE GET OUT THAT WILL BE
MORE CLINICALLY IMPACTFUL.
>> AND COLLABORATE WITH
PROFESSIONAL ORGANIZATIONS AS
ANOTHER WAY TO DO THAT.
>> THIS IS PERSONS WITH PAIN WHO
MAY BE MISUSING OPIOIDS AND HOW
TO ADDRESS THAT SUBPOPULATION IN
A WAY THAT'S EQUITABLE.
WE KNOW HOW THORNY THAT PROBLEM
IS BUT IT'S A LARGE SWATH OF
PEOPLE MISUSING OPIOID.
THEY MAY NOT EVEN HAVE OUD.
EVEN THE TERMINOLOGY, CARLOS, I
TAKE CARE OF SICKLE CELL DISEASE
PATIENTS SO THE TERMINOLOGY IS
NOT ACCURATE TO DATE AND WE
DON'T HAVE PROGRAMS IN MY MIND
TO ADDRESS MISTAKEN USE OF
OPIOIDS IF YOU WANT TO USE THAT
TERM FOR CHRONIC PAIN
POPULATIONS WITH WHAT TO
SUBSTITUTE IT WITH AND HOW TO
IDENTIFY IT AND I WONDERED IF
YOU CAN IDENTIFY, WALTER AND
CARLOS, WHERE IN YOUR PORTFOLIO
YOU'RE FOCUSSING ON THAT.
>> WE HAVE FOLKS THAT HAVE SOME
RISK FACTORS FOR HARMFUL EFFECTS
OF OPIOIDS.
THAT'S ONE STUDY.
AND THE OTHER IS A STUDY OF
TREATING PAIN AND PEOPLE HAVE
OPIOID USE DISORDER.
THOSE ARE THE TWO ONGOING
PROJECTS IN THIS SPACE RIGHT
NOW.
THEY'RE BOTH ANYBODY HAVE ANY --
HAS ANYBODY HAVE UPDATES?
>> IT'S ONE IS WHAT IS THE BEST
WAY TO TREAT PATIENTS.
WE HAVE A WORKING GROUP WITH CMS
AND ONE ISSUE THAT GETS IN THE
WAY OF PEOPLE GETTING TREATMENT
ESPECIALLY WITH MORE LIMITED
RESOURCES IS COVERAGE.
WE NEED TO DEVELOP THE SCIENCE
ON HOW TO TREAT PEOPLE WITHOUT
PUTTING THEM AT RISK OF
ADDICTION AND GET DATA TO GET
FDA APPROVAL AND EQUALLY
IMPORTANT FOR CMS COVERAGE.
MEDICARE COVERAGE DECIDES WHAT
WILL PAY FOR IN TERMS OF
TREATMENT.
>> THERE'S A GROUP OF PATIENTS
WITH A RISK FACTOR AND THEY'LL
GET RELIEF WHEREVER THEY CAN
INCLUDING THE STREETS AND PEOPLE
ARE AT RISK OF OPIOID MISUSE OUT
OF NEED TO HAVE THEIR PAIN
RELIEVED AND HAVING NO
APPROPRIATE COVERAGE OR SOURCE
OF RELIEF OTHER THAN MISUSE OF
OPIOIDS.
I'D LIKE TO SEE EMPHASIS ON THAT
AS WE GO ALONG.
I'D LIKE TO SEE A LARGER
PORTFOLIO THAN THE ONE YOU
DESCRIBED.
DEVOTED TO THAT YOU'D GET A
PROPORTION SURVEY AND SEE A
LARGE PROPORTION OF OPIOID
MISUSE IS AMONG PEOPLE WITH
CHRONIC PAIN.
>> I AGREE WITH YOU.
ONE OF THE DIFFICULTYIES
THERAPIES NOT COVERED OR
MEDICATION BASED THERAPIES ARE
NOT COVERED BY PUBLIC OR PRIVATE
INSURANCE LEADING TO OTHER
POTENTIAL AVENUES LIKE OPIOID
MISUSE IN A MALADAPTIVE WAY TO
RELIEVE PAIN.
ONE ISSUE KNOW AS WELL AS I DO
INAPPROPRIATE USE CAN LEAD TO
HYPERALG
HYPERALGESIA.
I THINK WE'RE ALL SAYING THE
SAME PROBLEM WE IDENTIFY BUT I'M
GLAD YOU BRING IT UP.
THEY'VE IDENTIFIED THIS CARTOON
ALMOST LIKE, PLEASE, GIVE US
SOMETHING TO PAY FOR.
HAS ANYONE SEEN THE CARTOON I'M
TALKING ABOUT?
>> IT'S A GREAT CARTOON.
>> EMPOWER DEVELOPED INTEGRATION
TREATMENT FOR CHRONIC PAIN AND
OPIOID DISORDER AND MISUSE.
THE TOPIC TIES INTO MIRACLE
DESCRIBING WHEN OPIOID HARMS
OUTWEIGH BENEFITS FOR CHRONIC
PAIN MANAGEMENT.
WE FUNDED TWO PROGRAMS WHO WILL
BE WORKING TOGETHER TO DEVELOP
SOLUTIONS AND INSIGHT INTO THE
ISSUE.
ONE OF THEM IS FROM THE YALE
KAISER SIDE AND LINDA BARNES IS
PART OF THE GROUP USING
QUALITATIVE APPROACHES TO GET AT
THE ISSUE.
THAT'S WHAT YALE IS DOING AND
OTHER GRANTEES.
THEY'LL BE LOOKING AT CLAIMS
ANALYSIS OF MISUSE OR OPIOID
RISK BEHAVIORS USING
ADMINISTRATIVE DATA SETS THAT
WILL GIVE US THE POPULATION
LEVEL AND SCOPING ADVANTAGE THAT
IS NOT OFFERED BY YALE.
THE QUESTION ON WHAT OPIOID RISK
AND HARMS WILL GO TO A PARTNER
CONSULTATION BOARD FROM PRIVATE
PAYERS AND PROFESSIONAL
ORGANIZATIONS, LIVED EXPERIENCE
COMMUNITY MEMBERS TO HELP US
DRIVE DATA DRIVEN EVIDENCE TO
THIS.
RIGHT NOW WE JUST HAVE OPINIONS
WITHOUT A LOT OF DATA TO SUPPORT
THAT.
THERE'S QUESTIONS ON OPIOID
RELATED HARMS AND WHO DECIDES
WHEN HARMS OUTWAY BENEFITS ARE
QUESTIONS WE'LL BE EXPLORING.
WE JUST ENTERED OUR SECOND YEAR
YEAR.
WE HAVE A LONG ROAD AHEAD.
IF YOU HAVE SPECIFIC SUGGESTIONS
OR INPUT WE DEFINITELY WELCOME
YOUR INSIGHT.
>> THANK YOU SO MUCH.
I WANT TO CHECK AND SEE IF THE
OTHER HANDS ARE RELATED TO THIS
POINT OR IF WE SHOULD MOVE ON?
>> THIS IS EXACTLY THE INPUT
WE'RE LOOKING FOR SO WE GREATLY
PATIENT IT THOUGH WE'RE RUNNING
A LITTLE BIT BEHIND.
>> I'M HAPPY TO HEAR ABOUT THE
PREVENTION INITIATIVES.
I'M WONDERING WHETHER PART OF
THIS IF THERE'S AN EFFORT TO
DEVELOP EARLY BIOMARKERS OF RISK
FOR ADDICTION.
WHICH INDIVIDUALS ARE
SUSCEPTIBLE TO THE EFFECTS OF
PARTICULAR DRUGS.
IT'S CLEAR MOST OF THE --
THERE'S ONLY A SEGMENT OF THE
POPULATION REALLY SUSCEPTIBLE TO
THE ENFORCING EFFECTS OF ANY
GIVEN DRUG AND PROBABLY
CHALLENGING TO DEVELOP
BIOMARKERS LIKE THAT BUT
WONDERING IF THERE'S EFFORTS IN
THAT DIRECTION.
>> I THINK WE CAN THINK OF
BIOMARKERS IN TWO DIFFERENT WAYS
ONE IS FOR RISK STRATIFICATION
AND RESPONSE.
RIGHT NOW THE BEST PREDICTORS
ARE PONG BASED MORE FOR SOCIO
DEMOGRAPHICS, COMORBIDITIES
LOOKING AT BIOMARKERS.
IT'S DIFFICULT NOT ONLY IN
SUBSTANCE USE BUT ACROSS ALL
PSYCHIATRY BIOMARKERS.
ONE PAPER IF YOU HAVE NOT READ
IS A PAPER THAT PROVIDES A GOOD
METHODS TO IDENTIFY PREDICTIVE
BIOMARKERS TO HELP IN MEDICATION
DEVELOPMENT.
THE PAPER IS NOT SPECIFICALLY
FOR SUBSTANCE USE BUT CERTAINLY
MANY LESSONS OR THOUGHTS HE HAS
AND WE SHOULD THINK ABOUT
DEVELOP BEING BIOMARKERS FOR
MEDICATION DEVELOPMENT.
>> ONE COMMENT WAS AROUND
CHRONIC PAIN.
WE SEE THIS A LOT AND IT'S
DIFFICULT TO TEASE INDIVIDUALS
OUT AND SOMETIMES THEY DON'T GET
WHAT THEY WANT AND THEY GO AN
AND BUE -- BUPRENORPHINE IS A
GREAT MEDICATION FOR THIS AND
MANY I FOLLOW-UP UP WITH GO ON
TO WORK AND THE FOOD INDUSTRIES
AND THINGS THEY'RE WORKING AND
CONSTANTLY HAVING TO LIFT AND
CARRY THINGS.
WE NEED MORE INTEREST IN USING
BUPRENORPHINE FOR INDIVIDUALS.
AGAIN, I HAVE ANECDOTAL EVIDENCE
BUT IT WOULD BE GREAT TO HAVE
THAT.
THE OTHER THING AND THANK YOU
FOR THE OVERVIEW OF EVERYTHING.
I CAN'T STRESS ENOUGH ABOUT HOW
THESE TOUCH POINTS FOR PEOPLE
WITH OPIATE USE DISORDER NEEDS
TO BE.
THEY DON'T GO TO PRIMARY CARE.
SO WE NEED TO FIND THEM PLACES,
COMMUNITY CENTERS WE'RE STARTING
THINGS AT OUR COMMUNITY PLACE
PEOPLE CAN WALK IN AND PROVIDE
TREATMENT THERE.
EMS, I CAN'T TELL YOU ENOUGH
ABOUT HOW MANY PEOPLE ARE SEEN
BY EMS AND HAVE OVERDOSES AND
CAN HAVE INITIATION OF TREATMENT
AT THAT POINT AND ALSO BESIDES
LOOKING AT THE LOW BARRIER
ACCESS WHERE PEOPLE CAN COME IN
AND OUT AND THE FACT SO MANY ARE
HOMELESS OR UNSTABLE HOUSING IS
HURTING US THE MOST.
HOW CAN WE DO THIS?
I HAVE INCREDIBLE IDEAS THAT
WOULD TAKE MILLIONS OF DOLLARS
BUT WE OFTEN TRY TO TAKE ONE
PERSON FROM A HOMELESS COMMUNITY
AND TRY TO GET THEM AND READY
BUT NOT NOT TAKE A COMMUNITY OF
PEOPLE WHO ARE HOMELESS, THOSE
ARE THEIR COMMUNITY AND TAKE THE
GROUP AND SEE WHICH ONES WOULD
WANT TO BE HOUSED AND PUT THE
RESOURCES IN THAT AREA FOR
TREATMENT AS WELL AS OTHER
RESOURCES BUT YOU NEED TO TAKE A
GROUP OF PEOPLE AND IT WOULD
TAKE LOTS OF MONEY.
THAT IS A RATE LIMITING STEP THE
OUTREACH.
WHEN YOU PUT PEOPLE BACK TO A
COMMUNITY THAT ARE USING, IT'S
NOT GOING TO WORK.
NO MATTER HOW MOTIVATED IS OR
GET SOMEONE ON TREATMENT YOU GO
BACK TO THAT COMMUNITY WHERE
EVERYONE IS USING.
YOU'RE NEVER GOING TO BE ABLE TO
GET OUT OF IT.
EVEN TAKING SMALLER COMMUNITIES
OF WHO IS LIVING IN CERTAIN
AREAS AND THAT ENCAMPMENT AND
PLACING THEM ALL IN PLACES AND
WORKING WITH THAT, THAT MAY BE
WORTH A LOT OF RESOURCES.
>> I BROUGHT UP A COUPLE
IMPORTANT ISSUES.
ONE IS THE IMPORTANCE OF SOCIAL
DETERMINATES OF HEALTH AND HOW
MUCH YOU PUT INTO SOCIAL
SERVICES VERSUS HEALTH CARE.
THAT'S A VERY DIFFICULT
DECISION.
THE OTHER ONE IS TALKING ABOUT
QUALITY OF CARE.
WE'RE WORKING IN NIDA AND HOW DO
WE BALANCE PROVIDING QUALITY
CARE WITH GIVING TO EVERYBODY
RESPECTING AND ENSURING WE
QUALITY OF CARE.
WE'RE DEVELOPING DIFFERENT
OFFERS TO DIFFERENT PEOPLE TO
GIVE SOMETHING THAT IS USEFUL.
AS WE DISCUSSED MANY TIMES AND
SOMETHING THAT COULD BE COVERED
BY MEDICARE OR MEDICAID OR
PRIVATE INSURANCE.
TRYING TO THREAD THAT NEEDLE IS
IMPORTANT.
I'M THANKFUL YOU REMIND US.
>> I THINK WE HAVE TO BE
COGNIZANT.
IT MAY NOT BE THE PERFECT THING
TO SAY AND I WOULDN'T SAY TAKE
WHAT YOU WANT AND I'LL GIVE YOU
THAT.
I'D CONSTANTLY GO OVER THIS IS
WHAT IS PROVEN TO BE EFFECTIVE
AND I WOULD CONSTANTLY TRY TO
MOTIVATE PEOPLE TO USE THAT
TREATMENT AND OF COURSE IF THEY
WERE NOT READY AT THAT POINT I
WOULD OFFER SOMETHING ELSE BUT I
WOULD NEVER STOP WITH WHAT I
THINK IS THE BEST TREATMENT.
SOMETIMES I FEEL LIKE WE'RE
REACHING A LITTLE BIT TOO FAR IN
THE OPPOSITE DIRECTION WITH
SUBSTANCE USE DISORDERS AND
PARTICULARLY OPIATE USE
DISORDER.
I GIVE OUT TONS OF NARCAN BUT
IT'S NOT THE TREATMENT.
I ALWAYS GO BACK TO WHAT THE
TREATMENT IS AND GIVE IT ANOTHER
SHOT.
MOST THE TIME I CAN GET PEOPLE
TO MOVE A LITTLE BIT.
>> IT'S A MATTER OF LET'S JUST
TALK ABOUT IT A LITTLE BIT AND
HOW ONE DOES THAT IN THE HEALTH
ENVIRONMENT SYSTEM.
WE CAN'T LOSE TRACK OF THAT OR
WE'LL END UP NOT REALLY MOVING
THE NEEDLE WHICH IS WHAT COULD
HAVE HAPPENED WITH A COMMUNITY
LIKE PEOPLE ARE STILL DYING WITH
HEAL AND PEOPLE ARE STILL
OVERDOSING.
I CAN'T GIVE OUT ENOUGH NARCAN
TO STOP THAT.
I HAVE TO START WITH GETTING
PEOPLE INTO TREATMENT.
AND TOTALLY WITH PREVENTION.
ALL RIGHT.
I'LL BE QUIET.
THANK YOU.
>> YOU CAN MAKE YOUR COMMENT BUT
I WANT TO NOTE WE'RE ALMOST 20
MINUTES BEHIND.
>> I'LL BE QUICK AND I HAVE TWO
COMMENTS.
ONE FALLS ON WHAT GAIL AND WALLY
BROUGHT UP.
WE HAVE AND A SUBSTANTIAL OF
PROPORTION OF PEOPLE IN OUR
TRIAL ARE PEOPLE WHO HAVE
CHRONIC PAIN AND WE HAVE VERY
DIFFERENT APPROACHES IN OUR
CLINICAL SITES ABOUT WHETHER TO
USE BUPRENORPHINE OR NOT AND
IT'S A SHAME WE DON'T HAVE THE
RESOURCE TO EXPLORE THIS FURTHER
BECAUSE OF THE MECHANISM.
SO JUST TO PUT A PLUG IN THERE'S
WAYS FOR SOME STUDIES WHERE
THERE'S GAINS IN THE MARGINS
WE'RE NOT ALWAYS ABLE TO
REALIZE.
MY QUESTION AND COMMENT WAS FOR
WALTER IS YOU HAD GONE THROUGH
THE LIST OF RECOMMENDATIONS BY
THE FEDERAL PAIN RESEARCH
STRATEGY.
THE FIRST BEING TO DEVELOP A
PAIN RESEARCH NETWORK AND I'M
CURIOUS, I KNOW THERE'S THE
PURPOSE NET WORK, THERE'S THE
PAIN ERN AND WHAT DR. CRISWELL
IS TALKING ABOUT IN TERMS OF
BACKPACK GETS AT SOME OF THIS
AND THEY GET AT A PIECE OF WHAT
THE FPRS WAS SUGGESTING WITH THE
PAIN RESEARCH NET WORK BUT NONE
SEEM FULLY ALIGNED WITH THAT.
I DON'T KNOW IF YOU HAVE ANY
OTHER THOUGHTS OR COMMENTS.
I KNOW WE'RE EARLY IN HEAL TOO
BUT IT WOULD BE GREAT TO SEE
SOME ELEMENTS UNDER THE PAIN
RESEARCH NETWORK GET MORE
ATTENTION AND DEVELOPMENT THAN
WE CURRENTLY HAVE.
>> WE CAN WORK ON THAT.
WE ALSO HAVE THE PRISM NETWORK.
WE HAVE DIFFERENT NETWORKS FOR
DIFFERENT AUDIENCES, ACADEMIC,
HEALTH CARE SYSTEMS.
>> CAN YOU TALK LOUDER.
>> WE SHOULD TALK OFFLINE HOW TO
DO BETTER.
>> THANK YOU.
COLLECTIVELY THEY'RE RESPONSIVE
TO THIS.
THANKS.
>> DR. GARLAND, LAST COMMENT.
THANK YOU.
I WAS STRUCK BY DR. BLANCO'S
COMMENT ABOUT NIDA'S HEAL
EFFORTS TO TRY TO TAKE PROGRAMS
THAT HAVE BEEN SHOWN TO BE
EFFICACIOUS AND SUSTAIN THEM IN
THE REAL WORLD AFTER THE HEAL
FUNDING HAS ENDED.
I'D LIKE TO HEAR MORE ABOUT THAT
AND BACK TO WALLY'S POINT ABOUT
PEOPLE WITH CHRONIC PAIN WHO
ALSO MAY BE MISUSING OPIOIDS AND
THE NEED TO ADDRESS THIS
POPULATION.
FOR EXAMPLE, WE'VE DEVELOPED IT
AN EVIDENCE BASED TREATMENT FOR
THIS POPULATION AND THE CLINICAL
TRIAL WAS SUCCESSFUL AND
REPLICATED IN MULTIPLE CLINICAL
TRIALS AT THIS POINT AND
EXPERIENCED THIS TRANSLATIONAL
GAP BETWEEN CONTROLLED RESEARCH
TO BRING THIS INTERVENTION OUT
IN THE REAL WORLD AND REALLY I
THINK THE BARRIER WE'VE
EXPERIENCED IS COMMENTS THAT
MOST PEOPLE IN THIS PIPELINE OF
TREATMENT DEVELOPMENT RESEARCH
IT SEEMS TO FALL INTO A BLACK
HOLE OF FUNDING AND THIS RELATES
TO POLICY BOTH AT THE LOCAL AND
STATE LEVELS.
I'M WONDERING WHAT CAN BE DONE
TO HELP BROKER THIS PATHWAY OF
TRANSLATIONAL GAP TO GET
THERAPIES THAT HAVE SHOWN TO BE
EFFICACIOUS OUT IN THE REAL
WORLD.
>>
>> WE SPECIFICALLY REQUIRED THE
APPLICANT WITH THE POTENTIAL
PARTNER THAT WE SUSTAINED THE
INTERVENTION AFTER THE RESEARCH
IS COMPLETED.
AND THERE ARE DIFFERENT LEVELS
OF REQUIREMENT.
WE HAVE TO BE FLEXIBLE.
WE WANT TO ENCOURAGE THAT.
AT THE SAME TIME WE HAVE TO
REALIZE THE TRADITION FOR MANY
YEARS HAS NOT BEEN THAT BUT
WE'RE MAKING PROGRESS AND PEOPLE
ARE GETTING VERY INTERESTED AND
WE'RE GENERATING MUCH BETTER
RESEARCH BECAUSE WE'RE
GENERATING RESEARCH THAT
RESPONDS TO THE NEEDS AND
CAPACITIES OF THE SYSTEMS WE
HAVE TO SCALE UP AND IMPLEMENT
THOSE.
SO THAT'S ONE THING WE'RE DOING.
THE SECOND THING WE'RE DOING IS
WE'RE WORKING ALL THE TIME AND
IT TAKES TIME AND EFFORT AND WE
WORK WITH MOSTLY CMS AND SAMHSA
TO SEE WHAT SOURCES OF REVENUES
THERE ARE.
THERE ARE POCKETS OF REVENUES
FOR OTHER SERVICES, THE JUSTICE
SYSTEM BUT WE TRY TO WORK WITH
DIFFERENT FUNDERS TO SEE IF
THOSE INTERVENTIONS WILL BE
SUSTAINABLE FOR THEM AND TO
IDENTIFY SOURCES OF FUNDING.
AND WE LOOKED AT STANDARD OF
CARE DISCOVERY AND SCIENTIFIC
TREATMENTS.
WE TRY TO EDUCATE DIFFERENT
STAKEHOLDERS WHEN YOU THINK OF
DOING RESEARCH, WHO IS GOING TO
BE THE USER KNOWLEDGE.
NOT ONLY IS IT GOING TO GO TO A
GOOD JOURNAL BUT CARRY THE
KNOWLEDGE FORWARD.
AND WE'RE TALKING ABOUT WHAT
SYSTEM IS GOING TO PAY FOR THIS.
IS KAISER GOING TO PAY FOR IT OR
MEDICARE OR MEDICAID?
COMMERCIAL INSURANCE, THE STATE
HEALTH DEPARTMENT?
WE'RE TRYING TO MOVE IN THOSE
TRACKS.
THINGS TAKE TIME IN LIFE BUT
THESE IS A THREE-PRONGED
APPROACH THAT WILL TAKE IMPACT.
I'M A SCIENTIST.
I'M A CLINICIAN AND WILLING TO
LEARN.
IF YOU HAVE SUGGESTIONS HOW TO
DO THINGS BETTER IF YOU HAVE AN
IDEA, THIS IS NOT HIGH SCHOOL I
DON'T WANT TO PUT YOU ON THE
SPOT BUT WE WANT TO GET THE BEST
IDEAS WE CAN.
AND WANT TO KNOW WHO GENERATES
THE IDEAS.
HOPEFULLY WE'LL GET SOMETHING
BACK FROM OTHERS.
>> THAT'S A LONGER CONVERSATION
BUT I THINK IT'S A CRITICAL ROLE
FOR HEAL TO HELP BROKER THOSE
RELATIONSHIPS BETWEEN P.I.s WHO
HAVE PULLED OFF THESE SUCCESSFUL
PROJECTS AND GENERATED
COMPELLING EVIDENCE AND THEN
CONNECTING THEM WITH POLICY
MAKERS AT THE STATE AND LOCAL
LEVEL WHO ARE DECIDING HOW TO
SPEND OPIOID SETTLEMENT FUNDS
AND OTHER RESOURCES TO GENERATE
EVIDENCE-BASED PRACTICE FOR
THEIR COMMUNITIES.
THAT'S A CRITICAL ROLE.
IF WE WANT THE EFFORTS THAT PUT
INTO HEAL TO MATTER PE HAVE TO
GET THAT FIGURED OUT SO THANK
YOU.
>> THANK YOU SO MUCH.
I APPRECIATE THE LIVELY
DISCUSSION.
NOW WE'LL GO TO OUR NEXT AGENDA
TOPIC.
SO I'D LIKE TO NOW WELCOME
DR. REDONNA CHANDLER.
SHE'S A LICENSED PSYCHOLOGIST
AND SERVES AT THE DIRECTOR OF
THE NIDA RESEARCH PROGRAM AND
ALSO THE DIRECTORS OF THE HEAL
AND COMMUNITY CENTER HER AREAS
OF EXPERTISE ARE INDIVIDUALS
1R068D WITH THE CRIMINAL JUSTICE
SYSTEM, CRIMINALS AND ADHERENCE
TO DRUG ABUSE TREATMENT AND HIV
CARE AND EVIDENCE-BASED
TREATMENT IN CLINICAL PRACTICE
SETTINGS.
DR. CHANDLER.
>> IS IT POSSIBLE FOR ME TO
SHARE MY SCREEN AND PRESENT MY
OWN SLIDES?
>> THANK YOU FOR THE OPPORTUNITY
TO SPEAK WITH YOU ALL.
IT'S BEEN A REAL PRIVILEGE TO BE
PART OF THE STUDY.
THIS STUDY HAS INVOLVED AN
AMAZING TEAM OF HUNDREDS OF
COMMUNITY MEMBERS, RESEARCHERS
AND NIDA STAFF.
BRIEFLY I'M GOING TO COVER AN
OVERVIEW OF THE STUDY AND THEN
DELVE INTO SPECIFIC RESULTS
ABOUT NALOXONE DISTRIBUTION FOR
DISTRIBUTION BUT SOME OF OUR
DISSEMINATION ACTIVITIES AND
SOME OF OUR LESSONS LEARNED TO
DATE.
AS A REMINDER, THE HEALING
COMMUNITY STUDY WAS CONDUCTED IN
HIGHLY IMPACTING COMMUNITIES IN
FOUR STATES INCLUDING A TOTAL
POPULATION OF OVER 10 BILLION
LIVES TO REDUCE OPIOID RELATED
OVERDOSES AND WE ALSO HAD
IMPORTANT SECONDARY OUTCOMES
INCLUDING INCREASING NALOXONE
DISTRIBUTION WHICH I'LL TALK
ABOUT AND INCREASING ACCESS AND
UTILIZATION OF OUD AND
DECREASING HIGH-USE PRESCRIBING.
THE STUDY WAS A PARALLEL ARM
RANDOMIZED WEIGHT LIST CONTROL
TRIAL WITH HALF THE 67
COMMUNITIES RANDOMIZED TO THE
INTERVENTION AND HALF TO
CONTROL.
PRIMARY AND SECONDARY OUTCOMES
COMPARED OVER A COMPARISON
PERIOD BETWEEN INTERVENTION AND
CONTROL AND HERE YOU CAN SEE THE
TIME LINE WE'RE CURRENTLY IN THE
GRAY BOX WITH DISSEMINATION
ACTIVITIES AND CLOSE OUT.
THE INTERVENTION HAD THREE
COMPONENTS AND COMMUNITY
ENGAGEMENT AND PROVIDED DATA AND
DASHBOARDS FOR A STRATEGY TO
DECREASE OPIOID OVERDOSE FATAL.
THE OPIOID CONTINUUM OF CARE
APPROACH A MENU OF
EVIDENCE-BASED PRACTICES
INTENDED TO AID COMMUNITIES IN
IMPLEMENTING THREE SPECIFIC
AREAS OVERDOSE EDUCATION AND
NALOXONE PRESCRIBING AND
CAMPAIGNS TO INCREASE EDUCATION
AND REDUCE STIGMA.
I'LL TALK ABOUT THE NALOXONE
DISTRIBUTION FINDINGS WE HOPE
WILL BE ACCEPTED IN THE AMERICAN
JOURNAL OF HEALTH.
THE DATA IS EMBARGO.
A REMINDER REGARDING NALOXONE
IT'S AN OPIOID AGONIST THAT
INCREASES THE ODDS OF SURVIVAL
COMPARED TO NO NALOXONE
DISTRIBUTION AND COMMUNITIES
WITH ENROLLMENT IN EDUCATION
HAVE LOWER RATES OF OPIOID
OVERDOSE DEATHS.
IN ADDITION, WE CREATED A LOT OF
OPIOID EDUCATION HUNDREDS OF
MATERIALS AVAILABLE WITHIN OUR
COMMUNITIES I'LL SHARE LATER.
THEY WERE DONE IN DIFFERENT
FORMATS AND TRAINING AND
MULTIPLE LANGUAGES.
I'LL SHOW THE TIME LINE FOR A
SPECIFIC REASON THAT APPLIES TO
THE NALOXONE DISTRIBUTION
EFFORTS.
YOU CAN SEE THE START OF THE
INTERVENTION JANUARY 2020.
THE INTERVENTION IS THAT WE WERE
STARTING TO IMPLEMENT OUR
EVIDENCE-BASED PRACTICES AND
WERE SUPPOSED TO BEGIN IN
OCTOBER AND HAD THE NATIONAL
SHUT DOWN WITH THE COVID-19
PANDEMIC WHICH BEGAN IN MARCH.
AS MANY RECALL IN APRIL OF THAT
YEAR WE SAW UNPRECEDENTED
UPTICKS IN OVERDOSE FATALITIES.
AUR FOUL OF OUR STATES HAD
FATALITIES THAT SURPASSED THOSE
OF ANY PREVIOUS TIME.
BASED ON THAT, THIS WAS IN A
COMMUNITY ENGAGED STUDY.
OUR COMMUNITY COALITION PIVOTED
RAPIDLY TO COORDINATION AND CAME
BACK TO US AND SAID WE CAN'T
REALLY WAIT UNTIL OCTOBER TO GO
THROUGH THE NICE STEPS OF THE
INTERVENTION AND DEVELOP A
COMPREHENSIVE RESPONSE STRATEGY.
THERE ARE THINGS WE CAN DO TO
GET NALOXONE DISTRIBUTED AND
EDUCATION OUT THERE.
WE DEVELOPED A FAST TRACK
INTERVENTION THAT BEGAN OVERDOSE
EDUCATION AS EARLY AS MAY 2020
WITH A FOCUS ON SECTORS WHERE
PEOPLE HAD BEEN OUT OF THE
COMMUNITY AND WERE TRANSITIONS
BACK LIKE THOSE IN JAILS.
WHEN I TALK ABOUT THE RESULTS I
WILL MAKE SURE YOU UNDERSTAND
HOW WE DEFINED OUR OUTCOMES FOR
NALOXONE DISTRIBUTION AND LOOKED
AT COMMUNITY DISTRIBUTION
INCLUDING ALL THE UNITS
DISTRIBUTED TO OUR PARTNER
AGENCIES AND PROGRAMS AND
PREVENTION SPECIALISTS, PHARMACY
DISPENSING WITH ANY NALOXONE
DISPOSED BY PHARMACIES IN
COMMUNITIES AND ALSO LOOKING AT
A TOTAL COMBINATION OF COMMUNITY
PLUS PHARMACY DISTRIBUTION.
THE DATA CAME FROM DIFFERENT
SOURCES THAT WERE IDENTIFIED
THROUGH OUR PARTNERSHIPS WITH
OUR COMMUNITIES AND THEY VARIED
SLIGHTLY ACROSS THE FOUR STATES
BECAUSE WE DO NOT HAVE CURRENTLY
ANY KIND OF NATIONAL LEVEL
ACCOUNTING OF THE DISTRIBUTION
OF NALOXONE.
THEN FOR AN IQVIA THEY MEASURED
NALOXONE UNITS DISPENSED BY
RETAIL PHARMACIES.
WE LOOKED AT ACTIVE PROACTIVELY
DELIVERING AT-RISK INDIVIDUALS
TO SOCIAL NETWORKS OR DELIVERING
IT TO EVERYONE IN SOME TYPE OF A
HIGH RISK VENUE.
THAT WOULD BE LIKE IN A JAIL
THAT IS GOING TO BE RELEASED AND
WE TARGETED HEALTH CARE SECTORS
LIKE HOSPITALS, FOR EXAMPLE.
WE REQUIRED ONE STRATEGY AS PART
OF THEIR RESPONSE STRATEGY.
WE WANTED TO PARTNER AND WORK
WITH THEM SO WE MADE OUR
REQUIREMENTS LIGHT.
YOU'LL SEE IN A MINUTE THE
SUCCESS OF PARTNERING AND WE HAD
SOMEONE WHO MADE A REQUEST AND A
PHARMACY OR COMMUNITY EVENT AND
WE ALSO HAD PROGRAMS.
THAT WAS OPTIONAL AND THEN ALSO
OPTIONAL WAS WORKING WITH FIRST
RESPONDER ADMINISTRATORS AROUND
INCREASING CAPACITY FOR HAVING
NALOXONE.
IF EACH OF THE INTERVENTION
COMMUNITIES CHOSE THE MINIMUM
NUMBER OF REQUIRED STRATEGIES
WEEDS HAVE A TOTAL OF 33.
WE HAVE A TOTAL OF 254
STRATEGIES THAT ARE COMMUNITIES
IN OUR INTERVENTION GROUP
SELECTED.
YOU CAN SEE HERE HOW THEY'RE
DIVIDED OUT ACROSS THE DIFFERENT
STATES WITH KENTUCKY LEADING THE
WAY.
KENTUCKY HAD THE LEAST AMOUNT OF
NALOXONE DISTRIBUTION SO THEY
LEANED INTO THAT PARTICULAR
COMPONENT OF THEIR RESPONSE
STRATEGY.
YOU SEE HOW THERE WERE ACTIVE
AND PASSIVE AND CAPACITY FOR
FIRST RESPONDERS AND ACTIVE OEND
INITIATIVES AND HERE YOU CAN SEE
THE DIFFERENT VENUES WHERE
NALOXONE DISTRIBUTION WITH THE
MAJORITY OF THOSE BEING WIN THE
BEHAVIORAL HEALTH SETTINGS
INCLUDING SUBSTANCE USE AND
MENTAL HEALTH TREATMENT
PROGRAMS.
GETTING TOWARDS THE RESULT I'LL
TALK ABOUT THE STATISTICAL
METHODS.
WE COMPARED RATES BETWEEN
INTERVENTION AND CONTROL
COMMUNITIES FROM JULY 1 OF 2021
THROUGH JUNE 30, 2022 WITH A
BASELINE PERIOD OF JANUARY 1,
2019 AND SMALL SAMPLE SIZES WERE
ADJUSTED WITH EMPIRICAL STANDARD
ERRORS FOR TESTING AND YOU CAN
SEE WE HAD DIFFERENT MODELS
ADJUSTED FOR RULES, STATUS,
STATE, OPIOID DEATH RATE AND
COMMUNITY-LEVEL RATE PER 100,000
RESIDENTS OF THE OUTCOME WHICH
IN THIS CASE IS NALOXONE
DISTRIBUTION.
IT'S VERY SIMILAR AND HERE'S
OUTCOMES.
YOU SEE THE THREE OUTCOMES WITH
RELATIVE RATES PER 100,000
RESIDENTS.
THERE'S STATISTICALLY
SIGNIFICANT INCREASE FOR
NALOXONE DISTRIBUTION AND
COMMUNITY PROGRAM DISTRIBUTION
WITH A 79% INCREASE BETWEEN
CONTROL AND INTERVENTION
COMMUNITY AND 104% INCREASE FOR
COMMUNITY PROGRAM DISTRIBUTION.
THERE WAS NOT A STATISTICALLY
SIGNIFICANT DIFFERENCE FOR
PHARMACY DISPENSED NALOXONE BUT
THAT WAS NOT SURPRISING.
COMMUNITIES DIDN'T FOCUS HEAVILY
ON PHARMACIES.
THEY TOOK THE RESPONSE
STRATEGIES THEY SELECTED FROM
INFORMATION THEY GLEANED FROM
MEMBERS AND THEIR COALITIONS
INCLUDING PEOPLE WITH LIVING
EXPERIENCE AND THEY LEARNED A
LOT ABOUT HOW UNCOMFORTABLE
PEOPLE ARE USING DRUGS GOING
INTO PHARMACIES AND HOW
UNCOMFORTABLE COMMUNITY MEMBERS
WERE GOING TOO A PHARMACY TO GET
NALOXONE AND BARRIERS.
THIS IS FROM A VENDING MACHINE
TO AN EVENT TO A GROUP OF
MOTORCYCLERS GOING OUT AND
DISTRIBUTING THIS TO THEIR
COMMUNITY AND THERE'S COMMUNITY
COALITIONS WITH THEY COMPLETE
SURVEYS AND THEY HAD PERCEIVED
BARRIERS TO SCALING UP OND IN
THEIR COMMUNITY AND THEY LOOKED
AT BASELINE INTERVENTION AND
FOUND THERE WAS A STATISTICALLY
SIGNIFICANT DECREASE AND
PERCEIVED BARRIERS FOR OND FOR
THE INTERVENTION GROUP AND
HEALTH CARE AND BEHAVIORAL
HEALTH SETTINGS AND
NON-TRADITIONAL VENUES WHICH
INCLUDED THINGS LIKE SYRINGE
SERVICE PROGRAMS AND IN THE OVER
ALL JUSTICE SETTINGS.
KENTUCKY ALONE HAD A
STATISTICALLY SIGNIFICANT
DIFFERENCE IN CHANGING
PERCEPTIONS OF BARRIERS FOR OEND
AND JUSTICE SETTINGS FOR THE
TREATMENT GROUP.
SO WE HAD STUDY LIMITATIONS.
THE PRIMARY LIMITATION OF THE
STUDY OF THE RESEARCH AT THIS
LEVEL IS THERE'S NO UNIFORM
CENTRALIZED SYSTEM FOR
COLLECTING DATA OR FOR
HARMONIZING THE DATA AT THE
COMMUNITY LEVEL.
IN SOME INSTANCES BECAUSE OF THE
OVERDOSE SPIKES IN FATALES THEY
INITIATED THEIR OWN EFFORTS THAT
IMPACTED ALL OF THE COMMUNITIES
BOTH INTERVENTION AND CONTROL.
IN OHIO THERE WAS AN UNDER
COUNTING OF THE NALOXONE
DISTRIBUTED.
IN SUMMARY, HCS WAS ABLE TO
QUICKLY MOBILIZE COMMUNITIES
DURING THE COVID-19 PANDEMIC AND
SCALE UP OEND.
OVERALL 33 STRATEGY REQUIRED AND
254 WERE DE MROIDZ AND TH -- DE
AND NALOXONE AVAILABILITY
INCREASED 79% AND THERE WERE
REDUCED PERCEIVED BARRIERS TO
DISTRIBUTION.
THESE ARE SOME OF OUR ACTIVITIES
THUS FAR.
AS PART OF A STUDY LIKE THE
STUDY WE'RE NOT JUST DEVELOPING
A PROTOCOL.
YOU'RE DEVELOPING COMMUNITY
FRIENDLY MATERIALS HOW TO BE
ABLE TO UP TAKE CERTAIN THINGS
AND HOW TO DO CERTAIN THINGS
LIKE DISTRIBUTE NALOXONE OR
START A BRIDGE CLINIC AND WE
BUILT OFF THOSE MATERIALS TO TRY
TO CREATE DISSEMINATION
PRODUCTS.
WE WORKED WITH SAMHSA AND
DEVELOPED TWO DISSEMINATION
PRODUCTS THROUGH THE PROGRAMS
AND WORKED TO DEVELOP CONNECTS
YOU SEE AND YOU'LL SEE AN ASK
THE EXPERT VIDEO AND WE
DEVELOPED A TOOL KIT FOR OPIOID
OVERDOSES AS A PRACTICAL GUIDE
FOR EMPLOYERS, COMMUNITY MEMBERS
AND FAITH LEADERS TO GIVE PRACT
CAM INFORMATION ON HOW THEY CAN
WORK ON TURNING THE TIDE ON THE
OPIOID CRISIS INCLUDING
COMMUNICATION MATERIALS AND HOW
THEY COMMUNICATE THROUGH STIGMA
AND ENCOURAGE TREATMENT AND TO
REVERSE OVERDOSES.
THERE ARE 181 PEOPLE REGISTERED
AUGUST 21.
I WAS NOT ABLE TO ATTEND THAT
AND NOT SURE HOW MANY PEOPLE
ATTENDED BUT WE HAVE HAD LARGE
NUMBERS OF PEOPLE ATTENDING ALL
OF THESE.
THIS IS INSIDES FOR HOW TO
ASSESS NEEDS AND WHAT FEATURES
TO BUILD IN AND BEST PRACTICES.
WE FOUND TRANSPORTATION WAS A
REALLY IMPORTANT BARRIER TO
PEOPLE INITIATING AND STAYING ON
MOUD AND THEY CONNECTED OVER
4,000 PATIENT TO TRANSPORTATION
SERVICE HELPED NOT ONLY
INITIATIVE MOUD BUT HELPED STAY
ON IT AND WE'RE PLEASED ABOUT AN
UPCOMING LEARN COLLABORATIVE.
WE HAD 206 APPLICATIONS
SUBMITTED AND WE'RE GOING TO BE
ABLE TO ACCEPT ONLY ABOUT 30.
SO THERE IS THIS HUNGER WITHIN
COMMUNITIES FOR LEARNING HOW TO
USE DATA AND CREATE DASHBOARDS
HELPFUL IN RESPONDING TO THE
OPIOID CRISIS.
THE APPLICATIONS ARE DUE AND
CURRENTLY BEING REVIEWED.
THIS IS A BRIEF SNIPPET OF OUR
SCRIPTS.
WE HAVE 80 PUBLISHED TO DATE.
WE HAVE OVER 76 MULTI-SITE
INVOLVING DATA FROM ACROSS THE
FOUR SITES AND HUNDREDS OF
SINGLE SITES IN PROCESS.
A FEW OF LESSONS LEARNED I'LL
FOCUS ON QUICKLY.
HCS IS THE LARGEST
IMPLEMENTATION STUDY EVER FUNDED
BY NIDA.
IT'S INTENDED TO DO WHAT YOU'RE
DOING IN YOUR PREVIOUS
DISCUSSION WHICH IS TO TAKE
EVIDENCE-BASED PRACTICES AND SEE
THEM STOOD UP ACROSS
COMMUNITIES.
CRITICAL TO THE SUCCESS OF THE
HUMAN COMMUNITY STUDY AND
APPROACH INVOLVING MULTI-LEVEL
PARTNERSHIPS AND MEETING PEOPLE
WHERE THEY WERE.
SOME COMMUNITIES HAD A LOT OF
STIGMA AND RESISTANCE AT FIRST
TO OPIOID USE DISORDER AND HAD
TO TRUST AND HAVE FAITH AND
CONFIDENCE IN THEM THEIR
EARNESTNESS WOULD COME TO THE
TABLE WHEN WE PROVIDED THEM WITH
DATA AND DEMONSTRATED SOME
INTERVENTIONS COULD BRING TO
BEAR ON DECREASING OVERDOSE
FATALITIES AND ABSOLUTELY SAW
THAT AND SAW OUR COMMUNITIES
STEP INTO SPACES AND PLACES THEY
NEVER IMAGINED THEY WOULD.
TIMELY DATA IS ESSENTIAL IN DEAL
WITH A HEALTH CRISIS INCLUDING
THE OPIOID HEALTH CRISIS AND WE
UNFORTUNATELY DON'T HAVE TIMELY
DATA SYSTEMS AT A PUBLIC HEALTH
LEVEL.
WE EXPERIENCED DELAYS ANYWHERE
FROM 24 TO 6 MONTHS AND IF
YOU'RE TRYING TO SAVE LIVES IT'S
FAR TOO LONG.
THERE'S MANY THINGS WE FOUND AT
A COUNTY LEVEL TO HAVE MORE
TIMELY DATA.
AND THERE'S AN APPROACH TO
IMPLEMENTING EVIDENCE-BASED
PRACTICES AND LEARNED OEND WAS
EASIER FOR THEM.
MOUD SERVED AS A GATEWAY TO GET
PEOPLE INTERESTED BUT IT TAKES A
LOT OF TIME TO PUT INTO PLACE
THESE DIFFERENT PROGRAMS FOR
MOUD BECAUSE OF REASONS
INCLUDING REGULATORY ISSUES.
AND SEE THE PUBLIC HEALTH
IMPACT.
AND THEY INDICATE WE WERE ABLE
TO CHANGE BEHAVIORS BY
INCREASING NALOXONE BECAUSE OF
OUR CAMPAIGNS AND THEN WE START
FROM DAY ONE PLANNING FOR
SUSTAINABILITY AND FOUND THAT
WAS CRITICAL.
WE WANTED THE ACTIVITIES TO
REMAIN AFTER RESEARCH SUPPORT
ENDED.
WE DID ALL KINDS OF THINGS FROM
TEACHING COMMUNITIES HOW TO
WRITE GRANTS AND APPLY FOR
FUNDING AND WORKING WITH THEM TO
THINK THROUGH WHOA MIGHT BE ABLE
AND WHERE THEY MIGHT BE ABLE TO
GET ONGOING SUPPORT.
SO THE COMMUNITY HAD A HUGE
ENDEAVOR.
A HUGE THANK YOU TO HUNDREDS OF
PEOPLE.
OUR COMMUNITY ADVISORY BOARDS
AND KEY GOVERNMENTAL OFFICIALS
AND COMMUNITY PARTNERS AND
INVESTIGATORS AND STAFF AND THEY
HELPED TO MAKE THIS A SUCCESS.
WITH THAT I WILL STOP SHARING.
>> I APPRECIATE THAT.
DO WE HAVE ANY QUESTIONS?
I THINK YOU WERE EXCEPTIONALLY
CLEAR.
THANK YOU FOR AN EXCEPTIONAL
OVERVIEW OF THAT IMPORTANT
PROGRAM.
I'LL TAKE A MOMENT TO MAKE SURE.
OKAY.
THANK YOU, SO MUCH.
WITH THAT, I JUST WANT TO NOTE
WE ARE NOW MOVING TO A BREAK.
WE ARE SCHEDULED FOR THE BREAK
TO END AT 1:15 BUT THAT'S NOT
ENOUGH SO I'LL GIVE US A
10-MINUTE BREAK AND RECONVENE
AROUND 1:20.
>> I'LL START WITH THE
MOTIVATION AND THE MISSION AND
GOALS.
THEN I'LL GO THROUGH THE
SPECIFIC PROGRAMS AND FUNDING
OPPORTUNITIES WE HAVE AVAILABLE
AND PROVIDE AN OVERVIEW OF OUR
PROGRAM'S ACCOMPLISHMENTS AND
FINISH BY HIGHLIGHTING SOME
PROJECTS WE FUNDED.
SO WHAT WAS AND WHAT IS THE
MOTIVATION FOR THE TRANSLATIONAL
DEVICES PROGRAM?
I THINK WE ALL REALIZE TO
EFFECTIVELY ADDRESS PAIN WE NEED
TO DELIVER THE BEST POSSIBLE
OUTCOMES FOR PATIENTS BOTH
HAVING ACCURATE DIAGNOSES OF A
PATIENT'S CONDITION AND MAKING A
MULTI-FACETED APPROACH TO
TREATMENT WHICH COULD INCLUDE
PHYSICAL AND PSYCHOLOGICAL AND
PHARMACOLOGIC AND
NON-PHARMACOLOGIC.
SEVERAL KEY CHALLENGES OR
LIMITATIONS PERSIST SUCH AS THE
ABILITY TO ACCURATELY DIAGNOSIS
WITH VALIDATED BIOMARKERS AND IN
THE TREATMENT SPACE THE EFFICACY
OF INTERVENTIONS VARIES WIDELY.
SOME HAVE ADDICTION LIABILITY
AND UNWANTED OFF-TARGET EFFECTS
AND FOR MANY THERAPIES, COST AND
ACCESS TO CARE IS A CHALLENGE.
AND THE TIME IT TAKES TO GET TO
PATIENTS IN NEED TAKES LONGER
THAN WE PREFER.
MEDICAL DEVICES CAN SERVE AS A
COMPLEMENT OR ALTERNATIVE
TREATMENT OPTION.
THERE'S MANY TYPES AVAILABLE
THAT CAN HELP ADDRESS THE
CHALLENGES I MENTIONED BEFORE
SUCH AS DIAGNOSTICS, IMPLANTABLE
DEVICES AND NON-INVASIVES AND
WEARABLE TECHNOLOGY.
THE MULTIPLE MODALITIES ALLOW
THEM TO BE APPLIED AT DIFFERENT
ANATOMICAL INTERVENTIONS
INTERACTING WITH THE SPINAL CORD
AND BRAIN.
THE FLEXIBILITY AND DESIGN OF
NEW INTERVENTIONS AND BECAUSE OF
THESE OPTIONS, DEVICES CAN OFFER
PRECISE TARGETING OR RECORDING
CAPABILITIES AND POSE LITTLE TO
NO ADDICTION LIABILITY.
THERE'S ALSO MULTIPLE REGULATORY
PATHWAYS WHICH CAN ACCELERATE TO
NEW PATIENTS WHO NEED THEM.
FOR HEAL IN OUR MISSION TO
ADDRESS PAIN AND OUD MORE
EFFECTIVELY DEVICES COULD MORE
ACCURATE DIAGNOSTICS AND GREATER
EFFICACY THROUGH PRECISE
TARGETING AND DESIGN OPTIONS AND
FLEXIBILITIES CAN ADDRESS NEW
INDICATIONS PROVIDING ADDITIONAL
OPTION FOR PATIENTS AND
CLINICIANS.
THIS ILLUSTRATES DISCOVERY
SCIENCE TO DEVELOPMENT AND
CLINICAL TRIALS AND FULL
CLINICAL IMPLEMENTATION AND
DISSEMINATION.
IN THE CENTER IS OUR
TRANSLATIONAL DEVICES PROGRAM.
THROUGH OUR VARIOUS FUNDING
OPTIONS WE'RE TARGETING TO
ADVANCE THE DEVELOPMENT OF
PROMISING NEW TECHNOLOGIES TO
THE CLINICAL RESEARCH SPACE.
IN 2018 WE LAUNCHED THE INITIAL
VERSION WITH THE GOAL OF
SUPPORTING NEXT GENERATION
MEDICAL DEVICES TO DIAGNOSE AND
TREAT PAIN MODELLING AFTER
COMPANION PROGRAMS LIKE HEAL
INITIATIVE AND OFFER FUNDING
OPPORTUNITIES THAT SPAN FROM
DEVELOPMENT TO EARLY STAGE
CLINICAL TRIALS.
TOWARDS THE LEFT WE HAVE
PROGRAMS TO SUPPORT DEVICE
DEVELOPMENT AND OPTIMIZE RATION
AND ON THE RIGHT SEVERAL
TRANSLATIONAL RESEARCH PROGRAMS
TO ADVANCE NEW DEVICE THERAPIES
INTO EARLY STAGE CLINICAL
TRIALS.
IN 2021 AND 2022 WE TACKLED NEW
ASPECTS OF THE TECHNOLOGY
RESEARCH SPACE.
WE EXPANDED THE SCOPE OF OUR
THERAPEUTIC DEVELOPMENT PROGRAMS
TO NOT ONLY INCLUDE DEVICES POR
PAIN BUT TO EXPAND TO OPIOID USE
DISORDER AND ANNOUNCED
INVOLVEMENT IN THE PROGRAM TO
FURTHER ENHANCE OUR
TRANSLATIONAL OFFERINGS AND IN
RESPONSE TO FEEDBACK SUPPORTING
MECHANISTIC RESEARCH INTO
MEDICAL DEVICES.
I'LL TAKE YOU THROUGH THE
PROGRAMS IN MORE DETAIL.
WE HAVE A TECHNOLOGY DEVELOPMENT
GRANT PROGRAM LED BY NIDID AND
THESE ARE GRANTS NOT HYPOTHESIS
DRIVEN BUT FOCUS ON DESIGN AND
DEVELOPMENT OR A NEW APPROACH IN
ADDRESSING PAIN OR OUD.
IN THEIR PROJECTS THEY NEED TO
DEMONSTRATE AND VALIDATE THE
TECHNOLOGY IN ASSAYS OR MODELS
RELEVANT FOR THE INDICATION OF
PAIN OR OUD.
THE GOAL IS TO PREPARE THEM FOR
FUTURE TRANSLATION AND THE DUE
DATE IS IN OCTOBER.
REACH OUT TO THE LEAD FOR THE
PROGRAM MY COLLEGIATE NIDID IF
YOU'RE INTERESTED.
WE HAVE PROGRAMS TO SUPPORT THE
ADVANCEMENT OF PAIN AND OUD IN
THE PAIN AND RESEARCH SPACE.
HEAL HAS PUBLISHED A NOTICE OF
SPECIAL INTEREST IN THE PROGRAM.
OPERATED BY THE BLUEPRINT FOR
NEUROSCIENCE RESEARCH IT'S AN
NIH INCUBATOR TO CATALYZE FROM
EARLY STAGE DEVELOPMENT TO FIRST
IN HUMAN CLINICAL TRIALS.
HERE IS VALIDATION AND IDE
ENABLING STUDIES AS WELL AS
EARLY STAGE CLINICAL TRIALS TO
DEMONSTRATE SAFETY AND INITIAL
INDICATORS OF EF CAS -- EFFICACY
FOR THERAPIES AND I'LL TAKE YOU
THROUGH HOW IT WORKS.
THERE'S TWO AIMS AND THE
DEVELOPMENT STAGE AND
TRANSLATION STAGE.
THE DEVELOPMENT STAGE IS TO NIH
FUNDED INCUBATOR HUBS ONE AT
JOHNS HOPKINS AND ONE AT HOWARD
UNIVERSITY AND ONE AT MGH.
THEY APPLY THROUGH AN
ACCELERATED APPLICATION PROCESS
THROUGH THE WEBSITE NEURO
BLUEPRINT.org.
SEEDLINGS ARE SMALL-SCALE GRANTS
FOR TEAMS WITH A COMPELLING
CONCEPT BUT MAY NEED TO ANSWER
ABOUT PLAN TO ADVANCING THROUGH
THE DEVELOPMENT PROCESS.
OPTIMIZER PROJECT RECEIVE LARGER
AWARDS THAT HAVE VALIDATION
THROUGH PRECLINICAL STUDIES.
FOR APPLICANTS WE HAVE A
TRANSLATOR PROGRAM.
APPLICANTS TO THIS PROGRAM CAN
FINISH UP WORK AND COMPLETE
ENABLING STUDIES AND BY THE END
OF THE FIRST PHASE GRANT IRB
APPROVAL TO INITIATE A CLINICAL
TRIAL IN THE SECOND PHASE OF THE
GRANT.
FOR THE TRANSLATOR PROGRAM, WE
OFFER A UG3 FUNDING OPTION FOR
ALL APPLICANTS AS WELL AS AN
SBIR U44 FAST TRACK PROGRAM FOR
SMALL BUSINESSES.
THE PROGRAM OFFERS RESOURCES AND
SUPPORT SERVICES TO FUNDED TEAMS
AT NO COST.
THROUGH CONTRACT RESEARCH
ORGANIZATIONS WE CAN PROVIDER A
VARIETY OF PRE CLINICAL
SERVICES, REGULATORY CONSULTING
AND CLINICAL CONSULTING TO HELP
DE RISK THE PATHWAY TO THE
CLINIC AND COMMERCIALIZATION.
INVESTIGATORS DON'T NEED TO
BUDGET FOR THESE SERVICES IN
THEIR GRANT APPLICATION.
THEY'RE PROVIDED SEPARATE VIA
THE CONTRACTS.
WE HAVE MULTIPLE UPCOMING
APPLICATION DUE DATES TO REACH
OUT IF YOU'RE INTERESTED IN THE
PROGRAM AS WELL.
OUR MECHANISTIC RESEARCH PROGRAM
INVESTIGATES THE MECHANISMS BY
WHICH FDA DEVICES WORK TO
DECREASE PAIN AND FROM THE
OBSERVATION MANY ARE ON MARKET
TO TREAT PAIN BUT IN MANY CASES
IT'S UNCLEAR HOW THEY WORK TO
RELIEVE PAIN.
PATIENTS EXPERIENCE A WIDE RANGE
OF OUTCOMES AND THERE CAN BE A
SIGNIFICANT GROUP OF PATIENTS
THAT DON'T RESPOND TO THERAPY.
THROUGH THE PROJECTS WE AIM TO
UNCOVER THE MECHANISMS, IDENTIFY
PHYSIOLOGICAL MARKERS OF PAIN
AND PAIN RELIEF AND IDENTIFY NEW
APPROACHES TO IMPROVE PATIENT
CARE WITH THE DEVICES.
WE REQUIRE APPLICANT TO USE TEAM
SCIENCE APPROACH BRINGING
SCIENTIFIC DISCIPLINES TO TACKLE
THESE ISSUES IN NEW WAYS AND
MAKE A STEP CHANGE IN THE BODY
OF EVIDENCE FOR THE UNDERLYING
MECHANISMS.
PROJECTS CAN FOCUS ON PRE
CLINICAL STUDIES AND MECHANISTIC
TRIALS OR A COMBINATION OF THE
TWO.
6:SO WHAT RESEARCH HAVE WE
SUPPORTED?
HEAL HAS INVESTED $87 MILLION
FOR 13 DISTINCT TECHNOLOGIES AND
INDICATIONS OF PAIN AND OUD.
THESE PROJECTS HAVE GARNERED
FIVE INVESTIGATIONAL DEVICE
EXEMPTIONS AND 11 CLINICAL
TRIALS ARE ONGOING AND COMPLETED
INCLUDING FEASIBILITY TRIALS AND
FIVE MECHANISTIC TRIALS.
SO FAR THE RESEARCH HAS RESULTED
IN OVER 100 PUBLICATIONS AS
TEAMS MEET THEIR ENDS POINTS IN
THEIR PROJECTS.
THE INVESTMENT REPRESENTS ABOUT
2.5% OF THE HEAL BUDGET OVER
THIS PERIOD OF TIME.
THIS ILLUSTRATED THE
DISTRIBUTION OR THE INTENDED
CLINICAL INDICATION ON THE
RIGHT.
THE SMALLEST CIRCLES AND SQUARES
HAVE MORE PROJECTS FUNDED AND
THERE'S BEEN A VARIETY OF DEVICE
TYPE AND ANATOMICAL LOCATIONS
TARGETED AND PAIN AND
INDICATIONS EXPLORED.
THIS SHOWS THE PROJECTS FUNDED
AND YOU CAN SEE WHETHER THEY'RE
DIAGNOSTIC OR THERAPEUTIC AND
THE PROJECT FOCUS AND OUD OR
PAIN POPULATIONS.
YOU CAN SEE WE SPREAD OUR
INVESTMENTS OVER A COMPREHENSIVE
COMBINATION OF DEVICE TYPES AND
OUD INDICATIONS.
WE HAVE EARLY FEASIBILITY TRIALS
IN CANCER PAIN AND IBS AND
SPINAL CORD INJURY PAIN AND
THEY'RE USING A VARIETY OF
DEVICE TYPES TO PROVIDE
THERAPIES.
WE HAVE MECHANISTIC TRIALS
FOCUSSED ON SPINAL CORD
STIMULATION AND STIMULATION FOR
PAIN DURING OPIOID WITHDRAWAL
AND BETTER UNDERSTANDING
PERIPHERAL NERVE STIMULATION FOR
CHRONIC NEURAL PATHIC PAIN.
I WANTED TO DIVE DEEPER INTO THE
TRANSLATIONAL DEVICES PROGRAM.
THE FIRST IS A DEVELOPMENT
PROJECT FROM UNIVERSITY OF
WISCONSIN-MADISON AND CARNEGIE
MELON UNIVERSITY AND AN
INJECTRODE THAT OVERCOMES
IMPROPER INJECTION AND HAS
ANCHORING FEATURES TO PREVENT
MIGRATION AND FULLY REMOVABLE.
THROUGH THE PROJECT THE TEAM
DEVELOPED SEVERAL PROTOTYPES AND
DEMONSTRATED FEASIBILITY OF GRD
STIMULATION IN A LARGE ANIMAL
MODEL AND MET WITH TO THE FDA TO
SEEK FEEDBACK AND THE TECHNOLOGY
HAS NOW BEGUN CLINICAL TRIALS
AND ADVANCING TOWARDS
COMMERCIALIZATION.
THE NEXT PROJECT FROM VANDERBILT
UNIVERSITY DEVELOPED FROM AN
IMAGE GUIDES NEURAL MODULATION
SYSTEM FOR PRECISELY TARGETING
PAIN CIRCUITS.
THE TEAM DEVELOPED THE
ULTRASOUND SYSTEM TO BE
COMPATIBLE WITH MRI SYSTEMS
TARGETING.
THEY WERE ABLE TO DEMONSTRATE
FEASIBILITY OF THE SYSTEM FOR
TARGETING NOT JUST PAIN SECTORS
IN A LARGE ANIMAL MODEL AND
AFTER COMPLETION THE TEAM HAS
NOW GRADUATED TO OUR PROGRAM TO
TRANSLATE AS A TREATMENT THE
TEAM IS TESTING A DEEP BRAIN
STIMULATION APPROACH FOR
TREATMENT OF REFRACTORY CHRONIC
PAIN IN A SMALL COHORT OF
PATIENTS.
THROUGH HEAL INITIATIVE AND
FUNDING THE TEAM IDENTIFIED AN
AREA OF THE BRAIN ASSOCIATED
WITH CHRONIC PAIN AND HAS BEEN
ABLE TO FIND OBJECTIVE
BIOMARKERS OF CHRONIC PAIN IN
INDIVIDUAL PATIENTS.
GECK -- GOING FORWARD THEY'LL
LOOK TO DEVELOP A CLOSE LOOP
DEEP BRAIN STIMULATION APPROACH
TO EFFECTIVELY MANAGE PAIN.
THE RESULTS FROM THEIR
NEUROSCIENCE PAPERWORK WAS
FEATURED AT THE HEAL SCIENTIFIC
MEETING AND THE PRESENTATION
INCLUDED A POWERFUL TESTIMONY
FROM A PATIENT ON THE TRIAL
WHICH IS STILL AVAILABLE IF YOU
MISSED IT.
THE TIME PROJECT I'D LIKE TO
HIGHLIGHT IS ONE OF OUR
MECHANISTIC CLINICAL TRIALS
DETERMINING THE WAY SPINAL CORD
STIMULATORS EFFECT PAIN WITH
THOSE WITH CHRONIC PAIN.
THIS IS AN INTERDISCIPLINARY
COLLABORATION BETWEEN MANY
ORGANIZATIONS AND THEY'RE
COMBINING MULTIPLE INNOVATIVE
TECHNIQUES TO BE ABLE TO
ELUCIDATE THE MECHANISMS USING
NERVE CONDUCTION STUDIES, MIC
MICRON
MICRONEUROGRAPHY AND MODULATING
THE EXCITABILITY LEEKED TO DROWN
STREAM PAIN RESPONSE.
FOR THE TRIAL RECRUITMENT IS
UNDERWAY AT THE VARIOUS
LOCATIONS FOR THE MULTI-SITE
TRIAL.
ED A LIKE TO CLOSE BY
RECOGNIZING THE AMAZING TEAM
THAT SUPPORT DEEPS TRANSLATION.
THESE ARE THE PROGRAMS NIBIB AND
NIDA AND MAKING ALL THE WORK
POSSIBLE.
ANYONE INTERESTED IN OUR PROGRAM
PLEASE REACH OUT AND WE'LL BE
HAPPY TO CHAT FURTHER ABOUT THE
OPPORTUNITIES.
NOW WE HAVE A FEW MINUTES FOR
DISCUSSION.
THERE ARE SOME PROMPTS TO
CONSIDER ON THE SCREEN AND THANK
YOU SO MUCH FOR YOUR ATTENTION
TODAY.
>> THANK YOU SO MUCH.
DOES ANYONE HAVE QUESTIONS FOR
ERIC?
ALLAN, PLEASE.
>> THIS IS PRETTY EXCITING, ALL
OF IT.
WHAT I FIND INTERESTING IS THE
USING OF SPINAL CORD STIMULATION
FOR SAY BACK PAIN.
THAT GETS BACK TO THE ISSUE WHEN
WALTER GAVE THE TALK IF THE
ASSUMPTION IS IT'S AN EFFECT ON
THE SPINAL CORD THE ASSUMPTION
IS THERE'S AN ABNORMAL INPUT
WHICH SUGGESTS THERE'S A DRIVER
IN THE PERIPHERY WHICH IS
EXACTLY THE OPPOSITE OF WHAT
ANOTHER PERSPECTIVE IS.
THERE'S EXISTING NOTION IT'S A
PRIMARY PAIN NOT A SECONDARY
PAIN NAMELY IT'S A PRODUCT OF
THE BRAIN NOT THE SPINAL CORD OR
PERIPHERY.
>> IT'S AN ONGOING CONSIDERATION
AND DISCUSSED AT LENGTH IN THE
TWO PROJECTS WE HAVE FUNDED
THROUGH THE MECHANISTIC RESEARCH
PROGRAM FOR SPINAL CORD
STIMULATION.
WE DO HAVE IN ADDITION TO THE
CLINICAL TRIAL PROJECT I
MENTIONED HERE WE HAVE A PROJECT
THAT'S FOCUSSING SOLELY ON PRE
CLINICAL STUDIES AND VARIOUS
ANIMAL MODELS TO SORT OF MORE
THE GRANULAR BASIC LEVEL TEASE
OUT WHAT THE MECHANISMS ARE IN
PAIN MODELS AND WHETHER THEY CAN
PROVIDE EVIDENCE FOR WHAT THE
ACTUAL MECHANISM IS AS YOU
SUGGESTED.
I SEE MICHAEL HAS HIS HAND
RAISED.
>> THANK YOU FOR THE QUESTION.
IF YOU LOOK AT THE PROJECT WHICH
ERIC ALLUDED TO EARLIER THAT'S A
DEEP BRAIN STIMULATOR -- FIRST
OF ALL IT'S RECORDING, AND THEN
LOOKING FOR ELECTROPHYSIOLOGICAL
SIGNATURE IN THE BRAIN AND
HAVING A CLOSED LOOP RESPONSE.
IT'S ALL RECORDING IN THE BRAIN
AND THEN STIMULATION IN THE
BRAIN AND FOR SOME PATIENTS,
IT'S BEEN ABSOLUTELY
TRANSFORMATIVE THEIR EXPERIENCE
AND QUALITY OF LIFE AND THEN
GETTING BACK TO WORK.
LIKE ERIC MENTIONED EARLIER ONE
OF THE PATIENTS THAT CAME TO THE
HEAL INVESTIGATOR MEETING AND
PRESENTED OVER THERE.
I THINK THROUGH THE COMBINATIONS
OF THE PROJECTS, AS WALTER
MENTIONED, THERE'S A ROLE FOR
BOTH.
THE CHANGES IN THE PHYSIOLOGY IN
THE PERIPHERY AND CHANGES IN THE
CIRCUIT CENTRALLY.
>> HAD I'D LIKE TO SHARE A
QUESTION REGARDING THE Q&A AND
METHODS FOR MEASURING PAIN AT
THE PEDIATRIC POPULATION FOR
INFANTS AND NEWBORN.
WHEREIN OUR PROGRAM WE DON'T
HAVE TARGETS WHETHER ON THE
MARKET OR AVAILABLE IN THE
CLINICAL RESEARCH SPACE THAT MAY
BE POINTING TO THAT.
>> WE DON'T CURRENTLY HAVE A
PROJECT FOR MEASURING OR
DIAGNOSING PAIN IN THE
POPULATION THAT MAY HAVE
DIFFICULTY ARTICULATING THEIR
PAIN OR VERBALLY DESCRIBING IT
BUT HAVE HAD HBAR PROJECT
TARGETED AT THE PEDIATRIC MARKET
SPERT ED -- SUPPORTED BY SBIR
AND HELPING OTHER INDIVIDUALS
WITH INJECTION PHOBIAS OR
SUSCEPTIBLE TO INJECTION PAIN.
>> AT THE MEASURE LEVEL THE
PERSON DOING MORE THAN THIS IS
REBECCA SLATER AT OXFORD WHO
DOES fMRI IN INFANTS.
TEA REMARKABLE AND THEY'RE
LOOKING AT MANAGEMENT.
I DON'T KNOW THEY'RE TRYING ANY
PARTICULAR TECHNOLOGIES TO TREAT
BUT THAT'S USED MUCH IN THE
STATES.
>> WE'LL LOOK INTO THAT.
>> HOPEFULLY WE'LL HAVE MORE
APPLICATIONS IN THE AREA TO
SUPPORT THE RESEARCH.
WE HAVE A PRECLINICAL PROJECT
WITH A PULSE OXIMETRY TECHNIQUE
FOR WITHDRAWAL SYNDROME TO
HOPEFULLY DEVELOP AN OBJECTIVE
MEASURE OF CONDITIONS FOR
INFANTS THAT LOOK AT SUBJECTIVE
MEASURES FROM STAFF AT
HOSPITALS.
>> IT'S TERRIBLE.
PARTICULARLY IN THE NEUROLOGICAL
DISORDERS WITH SEVERE
INTELLECTUAL DISABILITY IT WOULD
BE GREAT IF WE HAD A BETTER WAY
OF DOING THAT.
>> ONE OF THE OUTCOMES IS IT'S
UNIQUE TO THE INDIVIDUAL.
WITHOUT THAT INPUT VERBAL OR
OTHER SIGNS THE INDIVIDUAL IS IN
PAIN AND LOOKING AT THE SYMPHONY
GOING ON IN THE PAIN IT'S HARD
TO LOOK AT THE PAIN SIGNATURE
ACROSS INDIVIDUALS.
>> THE SAME GROUP HAS DONE
COMPARABLE THINGS IN EPILEPSY
RECORDING SEIZURES OVER TIME AND
THE SAME APPROACH WITH EDDIE
CHANG.
IT'S VERY EXCITING.
>> WE'LL NOW HAVE OUR NEXT
PRESENTATION FOCUSSED ON
REPORTING OUT FROM A RECENT
HEALTH EQUITY AND PAIN EQUITY
RESEARCH.
IT'S MY PLEASURE TO INTRODUCE
DR. CHERYSE SANKAR AND THE NEXT
IS DR. JANELLE LETZEN IN THE
OFFICE OF POLICY AND PLANNING.
>> I'M PRESENTING THIS
INFORMATION ON BEHALF OF
DR. SANKAR AND MYSELF AND TO
TOOT CHERYSE' HORN FOR A SECOND.
THE CREATED THE FIRST PORTFOLIO
OF PROGRAM TARGETING HEALTH
EQUITY AT NIH AND HIS WORKSHOP
WAS INSPIRED BY HER LEADERSHIP
IN THIS SPACE.
THE REASON WE NEEDED THE
WORKSHOP IS AND WE WANTED TO
GATHER EXPERTS FROM VARIOUS
BACKBOUNDS TO BEST UNDERSTAND
WHAT IS NEEDED TO START MOVING
THE NEEDLE FORWARD ON HEALTH
EQUITY.
PAIN DISPARITIES IS DEFINED BY
NIH AS PAIN DIFFERENCES THAT
HARM SOCIALLY DISADVANTAGED
POPULATIONS COMPARED TO
ADVANTAGED POPULATIONS AND THE
SOCIAL DISADVANTAGE STEMS FROM
SYSTEMIC FORMS OF DISCRIMINATION
AND RACISM, CLASSISM, ABLISM AND
OTHER FORMS OF SOCIAL
DISCRIMINATION.
THE NIH HAS SEVERAL DESIGNATED
POPULATION OR COMMUNITIES THAT
EXPERIENCE HEALTH DISPARITIES
AND THIS INCLUDES MINORITIZED
RACIAL AND ETHNIC GROUPS, PEOPLE
WITH LOWER SOCIO ECONOMIC
STATUS, UNDERSERVED RURAL
COMMUNITIES, MINORITIES AND
PEOPLE WITH DISABILITIES.
NOW MOVING TOWARDS HEALTH
EQUITY.
IT'S DEFINED AS A CONTINUAL
PROCESS MAKING SURE POPULATIONS
HAVE THE OPTIMAL OPPORTUNITY FOR
THE BEST HEALTH POSSIBLE AND
FAIRNESS.
THE MAJOR CONTRIBUTORS TO PAIN
DISPARITIES ARE THE SOCIAL
DETERMINATES OF HEALTH.
THIS INCLUDES THE NON-MEDICAL
FACTORS THAT EFFECT HEALTH LIKE
THE CONDITIONS WHERE PEOPLE ARE
BORN, GROW, LIVE, WORK AND AGE
AND ACCESS TO QUALITY EDUCATION
AND HEALTH CARE, A PERSON'S
NEIGHBORHOOD OR BUILT
ENVIRONMENT, THEIR SOCIAL AND
COMMUNITY CONTEXT AND ECONOMIC
STABILITY.
THE SOCIAL DETERMINATES OF
HEALTH AT DIFFERENT LEVELS AND
THERE'S INTERACTIONS WITH PEOPLE
AROUND THEM AND COME INTO
CONTACT WITH ORGANIZATIONS OR
INSTITUTIONS, LIVE IN THE
COMMUNITY AND OF COURSE ARE
MEMBERS OF THE GENERAL SOCIETY
ALL OF US LIVE IN.
WHERE WITH HAVE PAIN PREVENTION
AND RESEARCH HAPPENING IS AT THE
INDIVIDUAL LEVEL TARGETING THE
PERSON LIVING WITH PAIN.
SO THERE'S A GAP BETWEEN WHERE
INTERVENTIONS ARE NEEDED TO
ADDRESS PAIN DISPARITIES AND
WHERE THEY'RE HAPPENING.
BEFORE WE STARTED TO PLAN THE
WORKSHOP, WE WANTED TO FIRST GET
A SENSE OF WHAT THE PROGRAMS
THAT WERE ALREADY PROPOSED AT
LEAST WITHIN THE HEALTH EQUITY
AND PAIN MANAGEMENT RESEARCH
PORTFOLIO THE WAY THEY WERE
APPROACHING THE QUESTIONS.
WE REVIEWED THE 11-FUNDED
STUDIES WITHIN THE PROGRAMS TO
SEE WHAT THEY HAD PROPOSED IN
TERMS OF THREE DIFFERENT AREAS
THAT IN THE FIELD OF HEALTH
EQUITY RESEARCH ARE IMPORTANT
FOR SCIENCE.
SCO THE FIRST IS COMMUNITY
ENGAGEMENT AND WE WANTED TO
UNDERSTAND HOW THE RESEARCH
PROPOSALS WERE LOOKING AT ONE
AND HOW POPULATIONS EXPERIENCING
PAIN DISPARITIES WERE ENGAGED IN
THE RESEARCH PROJECT OR WOULD BE
ENGAGED IN THE RESEARCH PROJECT
FOR MULTI-LEVEL INTERVENTIONS.
WE WANTED TO SEE HOW THE
PROJECTS WERE PROPOSAL TO TARGET
SOCIAL DETERMINATES AT HEALTH
AND AT WHICH LEVELS OF SOCIETY
AND FINALLY WE WANTED TO
UNDERSTAND WHO WAS ON THE STUDY
TEAM AND WHETHER THERE WAS
ADEQUATE REPRESENTATION OF
COMMUNITY ENGAGEMENT EXPERTISE.
TO SUMMARIZE THE 11 PROPOSALS.
THE COMMUNITY ENGAGEMENT WAS
STRONGLY PROPOSED IN STUDYING
THE METHODS AND RECRUITMENT OF
PARTICIPANTS FOR STUDY WHERE
FEWER PROJECTS PROPOSED
COMMUNITY ENGAGEMENT AT THE
STAGES OF DEVELOPING THE IDEA
INVOLVING THE PEOPLE AND
DISSEMINATING BACK TO
COMMUNITIES.
WE WANTED TO UNDERSTAND WHAT
KINDS OF INTERVENTIONS WERE
PROPOSED AND TARGET THE
INDIVIDUAL WITH SOME TARGETING
SOCIAL DETERMINATES OF
ORGANIZATIONAL LEVEL.
IN TERMS OF THE HEALTH EQUITY
EXPERTISE REPRESENTED IN THE
GRANTS WE HAD A VARIETY OF
DIFFERENT SORTS OF PERSONNEL
WITH THE EXPERTISE AND SOME
PROJECTS HAD P.I.s ONE THE
EXPERTISE SOME HAD P.I.s AND
SOME A MIX.
USING THE INFORMATION WE TOOK IT
BACK TO HONE THE CHARGE OF THE
WORKSHOP AND BROADLY WE WANTED
TO KNOW HOW TO IMPROVE COMMUNITY
ENGAGEMENT ESPECIALLY ONE THE
POPULATIONS EXPERIENCING HEALTH
DISPARITIES IN PAIN RESEARCH?
AND LOOK AT INTERVENTIONS IN A
WAY THAT IS FEASIBLE AND HOW TO
PREVENT LEATH XT TOURISM WHEN
RESEARCHERS OUTSIDE THE HEALTH
EQUITY FIELD WHO PIVOT WHEN A
FUNDING ANNOUNCEMENT COMES OUT
BUT PIVOT OUT ONCE THE PROJECT
IS DONE.
WE HAD TWO PEOPLE WHO I'LL
HIGHLIGHT IN ADDITION TO CHERYSE
AND MYSELF IS JENNY AND KATIE
AND WE REALLY WANTED TO MAKE
SURE IT WOULD BE A POSITIVE
EXPERIENCE.
AND AS FAR AS THE STRUCTURE AND
THE VISUAL REPRESENTATION OF THE
PRESENTATION GIVEN BY CAMERON
YOUNG WHO IS AN 18-YEAR-OLD
TRANSGENDER MAN WITH A SYNDROME
HE'S HAD THROUGH CHILDHOOD AND
HIS SPEECH LITERALLY MOVED SOME
AUDIENCE MEMBERS TO TEARS AND
WERE SO HAPPY TO HAVE HIM THERE.
AS FAR AS THOSE DISCUSSION
PANELS, SOMETHING THAT WAS
IMPORTANT AND WE TRIED TO
PROMOTE EQUAL REPRESENTATION OF
HEALTH EQUITY LEVEL RESEARCHERS
OUTSIDE THE FIELD OF PAIN TO TRY
TO BRING IN NEW PERSPECTIVES.
ALSO OF PEOPLE WITH LIVED
EXPERIENCE OF PAIN WHO WE REFER
TO AS LIVED EXPERIENCE EXPERTS
AND THEN PAIN RESEARCHERS WHO
HAVE EXPERTISE IN PAIN
DISPARITIES.
THE NEXT THREE SLIDES I'LL SHARE
SUMMARIZE THE HIGH-LEVEL
TAKEAWAYS FROM THE PANEL
DISCUSSION AND REPRESENT THE
PANELIST VIEWS.
AND WE WERE CHARGED WITH TRYING
TO UNDERSTAND HOW TO STRENGTHEN
CONNECTEDNESS WITH COMMUNITIES
EXPERIENCING PAIN DISPARITIES.
THE WAY WE APPROACHED THE
DISCUSSION TOPIC IS THE ANALOGY
OF A HOUSE AND BUILDING A HOUSE
AS BUILDING RELATIONSHIPS WITH
COMMUNITIES.
WHAT THE PANELISTS DISCUSSED WAS
THAT IN A LOT OF CASES WE NEED
TO REALLY REPAIR THE FOUNDATION
AND HEAL BROKEN RELATIONSHIPS
WITH COMMUNITIES IT'S IMPORTANT
TO UNDERSTAND THE HISTORY OF THE
COMMUNITIES BOTH IN TERMS OF
DISCRIMINATION AND EXPERIENCES
HARMED WITHIN INSTITUTIONS AND
THE TYPE OF VALIDATION THAT
OFTEN OCCURS BECAUSE PAIN IS
INVISIBLE.
AND THEN ANOTHER IMPORTANT POINT
THEY RAISED TO REPAIR THESE
FOUNDATIONS WAS TO EMBED THE
RESEARCH TEAM INTO THE COMMUNITY
AND SO A COUPLE OF THE
RESEARCHERS HAD TALKED ABOUT HOW
ONCE A MONTH THEY PROVIDE TIME
FOR THEIR STAFF TO GO VOLUNTEER
INTO THE COMMUNITY AND REALLY
FOCUS ON BUILDING THOSE
RELATIONSHIPS.
AN DITION TO REPAIRING THE
FOUNDATION THEY TALKED ABOUT
KNOCKING DOWN WALLS IN HOPES OF
RECONCILING RELATIONSHIPS.
SO THEY DESCRIBED THIS BY
SHARING POWER AND VALUING
KNOWLEDGE AND COMMUNITY STRENGTH
S.
OFTEN TIMES WITH THE PAIN
INVISIBLE THE POWER IS IN THE
PROVIDER'S HANDS TO DECIDE WHAT
KINDS OF MEDICATIONS THEY'RE
GOING TO OFFER AND SAME WITH
RESEARCH, THE POWER IS IN THE
RESEARCHER'S HANDS WHAT THE
PARTICIPANT WILL GO THROUGH IN
THE STUDY AND WORKING ON SHARING
THAT POWER AND VALUING DIFFERENT
KNOWLEDGE, INDIGENOUS KNOWLEDGE
AND EXPERIENCE ARE IMPORTANT TO
BUILD RELATIONSHIPS WITH
COMMUNES.
EXPANDING THE SPACE WAS A WAY
THEY USED TO DESCRIBE BEING MORE
TRANSPARENT WITH COMMUNITIES AND
THIS IS REALLY ABOUT RESEARCHERS
BEING VULNERABLE ABOUT BOTH
THEIR LIMITATIONS OF RESEARCH IN
GENERAL AND THERE'S CERTAIN
THINGS RESEARCH CAN AND CAN'T
ANSWER AND THESE DISCUSSION
VALUABLE.
SOMETIMES WITH THE FOUNDATION
INSTEAD OF REPAIRING YOU MAY
NEED TO BUILD A NEW FOUNDATION.
THIS IS A WAY THE GROUP WAS
TALKING ABOUT CHANGING SYSTEMS
TO SUPPORT ENGAGEMENT AND SO FOR
EXAMPLE IN DOING COMMUNITY
ENGAGED RESEARCH IT REQUIRES A
LOT OF TIME AND RESOURCES
TOWARDS BUILDING THOSE
PARTNERSHIPS VERSUS PEOPLE OR
RESEARCHERS NOT DOING COMMUNITY
ENGAGEMENT MAY HAVE MORE TIME TO
DEDICATE TOWARDS PUBLISHING
PAPERS OR APPLYING FOR GRANTS.
ONE OF THE THINGS THE PANELIST
WAS TALKING ABOUT IS THE WAY
THAT PRODUCTIVITY IS MEASURED
COULD BE CHANGED.
AND FINALLY ADDING NEW FEATURES
WERE RESOURCES THEY DISCUSSED
WOULD BE HELPFUL FOR IMPROVING
COMMUNITY ENGAGEMENT WITH THOSE
COMMUNITIES.
FOR THE MULTI LEVEL INTERVENTION
PANEL WHAT THE GROUP FOCUSES ON
DISCUSSING WERE THE SOCIAL
DETERMINATES OF PAIN AT
DIFFERENT LEVELS OF SOCIETY AND
WHAT KINDS OF RESEARCH PROGRAMS
COULD BE BUILT TO TEST
INTERVENTIONS FOR THE SOCIAL
DETERMINATES.
I'M HIGHLIGHT A FEW THE GROUP
UP.
AT THE COMMUNITY OR NEIGHBORHOOD
LEVEL THE SOCIAL DETERMINATES OF
HEALTH THAT WAS PULLED OUT WAS
THE LACK OF NEARBY SERVICE OR
SERVICES OFFERED DURING WORK
HOURS WHERE PEOPLE MAY NOT BE
ABLE TO TAKE TIME OFF THEIR WORK
SCHEDULE TO SEEK THOSE SERVICE.
SO SOME RESEARCH PROGRAM AREAS
THAT WERE DISCUSSED WERE THINGS
LIKE BUILDING UNIQUE COMMUNITY
PARTNERSHIPS FOR PAIN MANAGEMENT
SERVICES, FOR EXAMPLE, WITH HIGH
SCHOOLS THAT MIGHT HAVE POOLS OR
WITH COMMUNITIES THAT MIGHT HAVE
POOLS THAT AREN'T USED DURING
THEIR PEAK HOURS TO PROVIDER
THOSE POOLS DURING OFF HOURS TO
PROVIDER GROUP AQUA THERAPY FOR
PEOPLE WITH PAIN.
ANOTHER THING WOULD BE TO
INCENTIVIZE PHARMACIES TO KEEP
THEIR STORED OPEN AND IN OTHER
AREAS AND IN CARDIOVASCULAR
HEALTH AND OBESITY THERE HAVE
BEEN BODEGAS TO HELP WITH HEALTH
AND ANOTHER IS NAVIGATING THE
HEALTH CARE SYSTEM AND THAT
SHOWS UP AT THE ORGANIZATIONAL
OR INSTITUTIONAL LEVEL AND CAN
BE AT THE INTERPERSONAL LEVEL AS
WELL.
SO SOME PROGRAMS OF RESEARCH
THAT WERE TALKED ABOUT IN THE
AREA WOULD BE THINGS LIKE HAVING
PEER NAVIGATORS FOR PAIN CARE AS
WELL AS COMMUNITY HEALTH WORKERS
PAIRED TOGETHER.
FINALLY THE WORKFORCE AND
COLLABORATION PANEL AT
UNDERSTANDING WHAT CORE
COMPETENCIES WOULD BE NEEDED TO
BUILD THE PAIN MANAGEMENT
WORKFORCE.
THERE ARE THREE BUCKETS THE CORE
COMPETENCIES FALL INTO THE
PERSONAL ATTRIBUTES OF THE
RESEARCHER, THE KNOWLEDGE AREAS
AND SKILLS.
AS FAR AS PERSONAL ATTRIBUTES
THEY HIGHLIGHTED CULTURAL
HUMANITY AND EMPATHY AS TWO
IMPORTANT ATTRIBUTES.
FOR KNOWLEDGE, DIFFERENT TOPIC
AREAS THAT WOULD BE IMPORTANT
ARE THE BIO PSYCHOSOCIAL MODEL
OF PAIN AND BETTER UNDERSTANDING
OF SOCIAL SYSTEMS INFLUENCE OF
PAIN AS WELL AS CULTURE'S
INFLUENCE ON PAIN AND TOOLS AND
INTERVENTIONS TO ANSWER RESEARCH
QUESTIONS.
NOT NECESSARILY HAVING FACILITY
WITH TOOLS AND INTERVENTION AND
KNOWLEDGE AND WHO THE KEY
COLLABORATORS COULD BE TO USE
THE TOOLS AND INTERVENTIONS.
AND FOR SKILLS THEY HAD
HIGHLIGHTED THAT ADVOCACY FOR
COMMUNITIES FACILITATE
COMMUNITY-LED RESEARCH AND
COLLABORATING ON
INTERDISCIPLINARY TEAMS AND
MENTORING IMPORTANT SKILLS TO
CULTIVATE IN THIS AREA.
FOR WHO SHOULD BE A PART OF THE
WORKFORCE, IN ADDITION TO THE
TRAINING WITH RESEARCH AND THOSE
BIG LIVED EXPERIENCE BECAUSE IT
NECESSITATES COMMUNITY
ENGAGEMENT SO HAVING THOSE WITH
LIVED EXPERIENCE PREPARED TO BE
PARTNERS IN RESEARCH PROJECTS
WOULD BE IMPORTANT.
THEY ALSO TALKED ABOUT HOW
DEVELOPING THESE CORE
COMPETENCIES NEEDED TO BE
MULTI-FACETED IN TERMS OF
LEARNING APPROACHES.
THE ONE THEY THOUGHT WAS
EXPERIENCE WAS EXPERIENTIAL
LEARNING.
BEING IN THE COMMUNITY WITH
COMMUNITIES, LEARNING FROM
COMMUNITIES BUT THEN ALSO OF
COURSE SOME TRAINING COURSES
THAT COULD COMPLEMENT THOSE
EXPERIENTIAL LEARNING MORE DA
DALT -- MODALITIES AND NOT
RELYING ON JUST ONE MENTOR BUT
HAVING DIFFERENT MENTORS FOR
DIFFERENT NEEDS.
WE WANT TO MAKE SURE THE
WORKSHOP DISCUSSIONS THEMSELVES
ARE NOT THE PLACE WHERE THE
WORKSHOP ENDS.
WE HAVE FOLLOW-UP ACTIVITIES
WE'RE CURRENTLY WORKING ON.
THE FIRST IS A WEBINAR WITH THE
WORKSHOP ATTENDEES HAPPENING IN
OCTOBER.
AND AT THE WEBINAR WE'RE GOING
TO DISCUSS A COUPLE OF PRODUCTS
COMING OUT OF THE WORKSHOP.
ONE IS AN EXECUTIVE SUMMARY.
ANOTHER IS A PROCEEDINGS PAPER
AND FINALLY ON THE PURPOSE
NETWORK PROMOTING COLLABORATION.
WE HAVE A COLLABORATION PAGE FOR
THE WORKSHOP ATTENDEES ON THE
PURPOSE NETWORK SO THEY CAN
CONTINUE TO WORK TOGETHER EVEN
OUTSIDE THESE ACTIVITIES THAT
WE'RE WORKING ON AS A GROUP TO
CONTINUE THEIR PROJECTS FORWARD.
SO WE HAVE A FEW DISCUSSION
QUESTIONS FOR ALL OF YOU TO
CONSIDER.
WE'D LOVE TO HEAR YOUR FEEDBACK
THE FIRST ONE ARE WHAT THIS ME
MOST IMPORTANT TOPICS TO ON IN
CONTINUING TO BUILD A PROGRAM.
WE'RE ALSO WONDERING WHAT
CONTENT RELATED TO HEALTH EQUITY
AND PAIN MANAGEMENT WAS NOT
COVERED IN THE WORKSHOP BUT
SHOULD BE FOCUSSED ON IN FUTURE
PROGRAMMING AND ASIDE FROM
BUILDING CORE COMPETENCIES HOW
ELSE CAN WE CREATE A SUSTAINABLE
RESEARCH WORKFORCE IN HEALTH
EQUITY AND PAIN MANAGEMENT?
AND WITH THAT, I'LL WRAP UP THE
PRESENTATION AND INVITE
DR. CHERYSE SANKAR TO JOIN FOR
THE QUESTION AND ANSWER
QUESTION.
THANK YOU.
>> I JUST GOT OFF A PLANE AND
DIDN'T THINK I'D MAKE IT IN TIME
SO THANK YOU, JANELLE AND WAIT
TO TAKE QUESTIONS IF NEEDED.
>> CHECKING IN IF ANYONE HAS
QUESTION OR FEEDBACK FOR JANELLE
OR CHERYSE?
OKAY.
WELL, THANK YOU SO MUCH TO EACH
OF YOU FOR AN EXCELLENT
PRESENTATION.
THIS IS OUR LAST PRESENTATION IN
OPEN SESSION AND FOCUSSED ON THE
THERAPEUTIC PROGRAM OUT OF NIDA.
I WANT TO WELCOME DR. JANE ACRI
THE DEPUTY DIRECTOR OF NIDA'S
DIVISION OF THERAPEUTICS AND
CONSEQUENCES AND WAS CHIEF OF
THE TOXICOLOGY BRANCH AND
DIRECTOR OF THE PRECLINICAL
ADDICTION TREATMENT DISCOVERY
PROGRAM.
UP ADDITION TO HER DUTIES AS
DEPUTY DIRECTOR SHE SERVES ON
THE EXECUTIVE COMMITTEE FOR THE
HEAL PRE CLINICAL SCREENING
PROGRAM AND HAS PARTICIPATED AS
AN AD HOC MEETING IN THREE FDA
ADVISORY PANEL FOR THE REVIEW OF
NEW DRUG APPLICATIONS.
>> THANK YOU FOR THE
INTRODUCTION.
I WASN'T EXPECTING THAT.
THANK YOU FOR THE OPPORTUNITY TO
PRESENT AN UPDATE ON OUR
THERAPEUTICS DEVELOPMENT PROGRAM
TODAY.
I'M GOING TO FOCUS ON THE CHANGE
S AND UPDATES FROM OCTOBER OF
2023.
THE DIVISION OF THERAPEUTICS AND
MEDICAL CONSEQUENCES WAS
ACTUALLY ESTABLISHED BY AN ACT
OF CAUCUS IN 1990 WITH A MISSION
TO ADDRESS THE CRACK COPAIN
PROBLEM THAT WAS PREVALENT AT
THAT TIME BY DEVELOPING
TREATMENT MEDICATIONS FOR
SUBSTANCE USE DISORDERS MAINLY
COCAINE.
INS SINCE THAT TIME OUR MISSION
HAS EXPANDED TO FOR THE
DEVELOPMENT OF MEDICATIONS,
BIOLOGICS, BEHAVIORAL THERAPIES
AND MECHANISMS FOR THE TREATMENT
OF SUBSTANCE USE DISORDERS WITH
STIMULANTS, CANNABIS AND
NICOTINE.
OUR GOAL IS TO THE DEVELOPMENT
OF SAFE AND EFFECTIVE
THERAPEUTICS.
WE HAVE FIVE FLAGSHIP FUNDING
OPPORTUNITY ANNOUNCEMENTS.
THEY HAVE SPECIAL REVIEW PANEL
TO ENSURE THE APPROPRIATE
EXPERTISE IS AVAILABLE IN
REVIEW.
MANY ARE U MECHANISMS OR
COOPERATIVE AGREEMENTS THAT
INCLUDE A SIGNIFICANT
INVOLVEMENT OF PROGRAM FOR
GUIDANCE.
ALL ARE MILESTONE DRIVEN WITH
SPECIFIC AND UNIQUE MARKERS OF
PROGRESS SPECIFIC TO THE PROJECT
AND SOME ARE PHASED AWARDS
ALLOWING AN ASSESSMENT OF
PROJECT PROCESS AND FEASIBILITY.
THE UHGs AND TREATING STIMULANT
USE DISORDER AND OPIOID DISORDER
AND THE AGREEMENT IS A FIVE-YEAR
PROGRAM.
THE GRANT OPPORTUNITY AND
MEDICATION DEVELOPMENT FOR
SUBSTANCE USE DISORDERS IS AN UL
1 A THREE-YEAR PROJECT WITH A
LARGER PROJECT THAN THE UG3s AND
THE DEVICE-BASED TREATMENT FOR
SUBSTANCE USE DISORDERS IS UH3,
UG3 WITH MILESTONES AND
DEVELOPING DIGITAL BASED
TREATMENTS IS A UGB AND UH3 AND
FINAL THE BEHAVIORAL IS R21s.
FOR THE TWO FLAGSHIP NOFOs THE
DEVELOPMENT OF MEDICATIONS TO
TREAT OPIOID AND STIMULANT USE
DISORDERS IN OVERDOSE AND THE
GRANT OPPORTUNITY FOR MEDICATION
DEVELOPMENT FOR SUBSTANCE USE
DISORDERS, WE HAVE AN OVER ALL
SUCCESS RATE OF ABOUT 20%.
WE HAVE SOME THAT CAME INTO HEAL
LATER AND THE SUCCESS RATES FOR
THE LAST ROUNDS HAVE BEEN ONLY
ABOUT 10% BUT WE'RE HOPING THAT
WILL INCREASE IN FUTURE ROUNDS.
I THINK THAT'S DRIVEN BY THE
FACT WE'RE GETTING MORE
APPLICATIONS PER ROUND.
THIS IS A SNAPSHOT OF WHAT WE
CALL OUR PIPELINE WHICH IS SET
UP AS A MEDICATION DEVELOPMENT
FOR PROGRESSION STARTING WITH
EARLY PRECLINICAL WHICH COULD
INCLUDE DISCOVERY WORK AND
PREDICTIVE TOXICOLOGY AND
SYNTHESIS PROCESS DEVELOPMENT
AND PRE CLINICAL IS USUALLY IND
ENABLING STUDIES AND PHASE 1 IS
FIRST IN MAN OR DRUG-DRUG
INTERACTION STUDIES WITH OTHER
TREATMENT DRUGS REQUIRED WITH
THE FDA AND PHASE 2 IS FURTHER
INTERACTIONS STUDIES AND PHASE
III WOULD BE REGISTRATION
TRIALS.
NEW REGISTRATIONS ARE GIVEN
THEIR OWN COLUMN.
THE PATHWAY DOESN'T ALLOW
BIOLOGICAL COMPARISONS WITH
MARKETS PATHWAYS AND
FORMULATIONS OF EXISTING DRUGS.
WE HAVE A TOTAL SHOWN OF 82 AND
IT'S BETWEEN 81 AND 83.
THIS SHOWS THE PROJECTS THAT
HAVE FALLEN OFF THE RADAR SINCE
THE BEGINNING.
THEY RELINQUISHED THE COUNT SO
IN SOME CASES THE INACTIVE
PROJECTS REPRESENT A FAILURE BUT
IN SOME THEY REPRESENT A
SUCCESS.
THIS IS GOING TO SHOW YOU THE
PROJECTS APPROVED FOR FUNDING
SINCE THE LAST UPDATE IN OCTOBER
OF 2023.
THERE'S SIX IN YELLOW ACROSS
THE SPAN OF DEVELOPMENT WHICH IS
A FUNCTION OF WHERE THEY COME TO
US AND COME IN.
THE FIRST PROJECT IS A
LONG-ACTING NEW OPIOID
ANTAGONIST SHOWN TO HAVE A LONG
DURATION IN THE BLOCKADE OF NEW
OPIOID INDUCED RESPIRATORY
DEPRESSION AND OPIOID INDUCED
ADMINISTRATION AND SOME HAVE
FOCUSSED ON FENTANYL AND
BLOCKING THOSE EFFECTS.
STHIGS --
>> THIS IS A FOLLOW-UP GRANT AND
WORKED OUT THE PROCESS
DEVELOPMENT AND IN THE UL 1 THEY
WILL COMPLETE THE SYNTHESIS
FOLLOWING THE IND AND MOVE INTO
PHASE I FIRST IN HUMAN STUDIES.
WE HOPE TO HAVE AN IND BY THE
END OF THE YEAR.
GM3009 IS A NEW SET OF THESE
THERAPEUTIC WHILE ADDRESSING THE
RISK TO PATIENT SAFETY IT HAS
ENHANCED EFFICACY THERE'S
INTOXIN PK AND THE UH3 ASSUMING
IT'S SUCCESSFUL WILL CONDUCT
FIRST IN HUMAN TRIALS IN HEALTHY
VOLUNTEERS FOLLOWED BY EFFICACY
STUDIES.
THE COMPOUND IS EXPECTED TO
PROVIDE RAPID AND LONG-TERM
MITIGATION OF ACUTE AND
PROTRACTED WITHDRAWALS IN
SYMPTOMS WITH OUD.
LOFEXADINE IS BEING DEVELOPED
AND IT DEVELOPED AN ALPHA 2
AGONIST FOR THE TREATMENT OF
OPIOID WITHDRAWALS IN ADULTS.
APPROVED BY THE FDA IN 2018 OR
'19.
THEY WORKED WITH THE FDA TO
DETERMINE WHAT THE DEVELOPMENT
PATH WOULD BE AND CONDUCTING
NON-CLINICAL SAFETY STUDIES FOR
AGE-SPECIFIC FORMULATION TO
VEELT THE PK IN 12 TO
17-YEAR-OLDS AND EVALUATE THE
RISK AND BENEFITS.
6:
THIS WOULD BE A FIRST MEDICATION
SPECIFICALLY FOR ADOLESCENTS.
NRS033 IS A LONG ACTING OPIOID
ANTAGONIST TO MARKET AS AN
INJECTABLE AND STABLE AND READY
IN PRE-FILLEDED SYRINGES AND THE
COMPLETION OF PHASE I STUDIES
OCCURRED IN THE PREVIOUS GRANT
SO AND IT'S LONGER THAN
NALTREXONE AND WILL CONDUCT
PHASE III REGISTRATION TRIALS
FOR FDA APPROVAL.
AND THIS IS A FAST-TRACKED FDA
PRODUCT THIS IS COMPLICATED
BECAUSE THE OXYCODONE FORMULATED
SO IT REQUIRE THE ENZYME TRIPSAN
TO RELEASE IT AND THE INHIBITOR
IS RELEASED AND THAT BLOCKS IT
IN THE QUAIS MULTIPLE DOSE UNITS
ARE CONSUMED.
THE ACTIVATION IS CALLED TRIP
AND BOTH TECHNOLOGIES ARE ALSO
BEING USED TO DEVELOP DRUGS FOR
OUD.
THIS RESOURCE D FAST TRACK
APPROVAL AND APPROVED FOR
FUNDING SINCE THE LAST
PRESENTATION IN OCTOBER.
SO WE HAVE SEVERAL PROJECTS THAT
TRANSITION MEANING IN THE UG3
PHASE AND TRANSITIONED TO THE
UH3 PHASE WHICH WE CONSIDER TO
BE A BIG DEAL BECAUSE WE DO
QUITE AN EXTENSIVE REVIEW OF THE
PROGRESS AT THE END OF THE UG3
TO MAKE SURE THE PROJECT IS
FEASIBLE AND PRACTICAL FOR
TRANSITION TO UH3.
WE HAVE PROJECTS THAT HAVE
TRANSITIONED AND THE FIRST ONE
IS AZD4041 FIRST IN CLASS.
IT'S BEN PENETRANT AND ENGAGES
RECEPTORS IN RATS AND IN HUMANS.
THE COMPANY WHICH IS
ASTRAZENECA, THE GRANTEE
INSTITUTION COMPLETED A
SUCCESSFUL FIRST IN STUDY TRIAL
IN THE UG 3 AND WILL POISE A
TRIAL IN COMBINATION WITH
BUPRENORPHINE TO IMPROVE
ABSTINENCE FROM A 12 WEEK STUDY.
ANOTHER PROJECT THAT'S
SUCCESSFUL TRANSITIONED WILL BE
LOOKING AT SEMAGLUTIDE.
AND THEY'VE BEEN SHOWN TO REDUCE
HEROIN STREAKING AND STRESS
REDUCED REINSTATEMENT IN RATS.
SO THIS IS A TRANSITION OF A UB
3 TO A UH3.
THE P.I. IS FROM PENN STATE AND
THEY CONDUCTED A SMALL TRIAL IN
A TREATMENT CENTER.
IT'S NOT PUBLISHED BUT HAS BEEN
PRESENTED PUBLICALLY SO WE CAN
TALK ABOUT IT.
THEY HAD A SHORTER AGONIST
COMPARED TO PLACEBO IN PATIENTS
MANE -- MAINTAINED ON
BUPRENORPHINE.
AND WE'LL HAVE A FOLLOW-UP TO
LOOK AT THE EFFICACY OF
SEMAGLUTIDE FOR THOSE ON THIS
DISORDER.
SO BIOPIN 6 AN UG 3 THAT
TRANSITIONED TO THE UH3 IN THE
NEW FORMULATION COLUMN.
THIS IS AN ABSORBABLE NALTREXONE
IMPLANT THAT PROVIDES OPIOID
BLOCKADE FOR AT LEAST THREE
MONTHS.
IT'S EXPLORED DIFFERENT
FORMULATIONS, A LIPOSOMAL
TRANSITION OF THE IMPLANT AND TO
EF THE THERAPEUTIC SERUM LEVELS
WHICH WOULD BE REQUIRED FOR THE
LONG-TERM IMPLANT, THEY FOCUSSED
ON REFINEMENT MUCH THE SURGICAL
PROCEDURES FOR IMPLANTATION AND
THE INSTRUMENTATION USED.
THEY'LL CONDUCT A SIX TO
12-MONTH STUDY TO EXAMINE THE
SAFETY AND EFFICACY OF THE
IMPLANT.
THE NEXT SLIDE GOES TO OUR
STIMULANT USE DISORDER AND I'LL
TALK ABOUT A COUPLE OF THE
PROJECTS.
SO THE FIRST OR THE ONLY ONE
I'LL TALK ABOUT IS BEING
DEVELOPED BY BIOCOREX A
SUBCUTANEOUS NALTREXONE IMPLANT
FOR METHAMPHETAMINE USE DISORDER
WHERE WE HAVE FEW PROJECTS IN
THE PIPELINE.
THE PHASE I WHAT'S BEEN
COMPLETED AND SHOWN IT BE SAFE
AND EACH DRUG ALONE IN A
MULTI-ARM STUDY.
SO WE'RE LOOKING FORWARD TO
SEEING THOSE RESULTS.
AND NOW I'M GOING TO TALK ABOUT
SOME OF OUR THERAPEUTIC DEVICES
IN OUR PIPELINE.
THESE ARE SHOWN HERE IN YELLOW
ARE THE ONES FUNDED BY HEAL.
SO THIS IS A PROJECT YOU MIGHT
HAVE SEEN ON 60 MINUTES.
THIS IS A UH3 AWARDED TO WEST
VIRGINIA UNIVERSITY.
STARTED USING DEEP BRAIN
STIMULATION OF THE NUCLEUS
ACCUMBENS IN THOSE TERMED
TREATMENT RESISTANT AND BEEN IN
SEVERAL TREATMENTS AN FAILED AND
FOUND THIS TO BE SAFE AND
EFFECTIVE AND HE INTERVIEWS SOME
OF THE PATIENTS WHOSE SITUATION
WAS GREATLY IMPROVED AND BECAUSE
THE PROCEDURE IS SO INVASIVE HE
HAS SHIFTED TO LOOKING AT LOW
INTENSITY ULTRASOUND AND SHOWN
IT TO BE SAFE AND WELL TOLERATE
AND REPORTED IT DECREASED
CRAVING ACUTELY AND AT 90-DAY
FOLLOW-UP.
IT'S PREFERABLE BECAUSE IT'S NOT
INVASIVE AND COMPARED TO SHAM
SONICATIONS WITH THE PUSH
PROCEDURE IT HAS SHOWN TO
DISCONNECT BETWEEN CUE INDUCED
CRAVING IN PEOPLE WITH OPIOID
USE DISORDER.
THIS USES DIRECT CRANIAL
STIMULATION WITH ENGAGEMENT OF
THE COGNITIVE CONTROL NETWORK
WITH THOSE ON BUPRENORPHINE OR
IN METHADONE.
THE CURRENT STIMULATION INCLUDES
THIS OVER THE RIGHT PREFRONTAL
CORTEX AND ACTIVATION OF THE
COGNITIVE CONTROL NETWORK MEANS
THE SUBJECT IS ENGAGED IN
COGNITIVE TASKS WHILE THE
STIMULATION IS GOING ON.
SO APPARENTLY BOTH HAVE TO BE
DONE TOGETHER.
THE PRELIMINARY STUDIES SUGGEST
INCREASED ACTIVITY RELEVANT TO
SHAM PROCEDURE AND DECREASED IN
OPIOID CRAVINGS THAT WERE
REPORTED POST TREATMENT.
THIS WORK IS BEING CONDUCTED AT
BUTLER HOSPITAL IN PROVIDENCE,
RHODE ISLAND.
THE FINAL PROJECT AND THE FINAL
PROJECT IS NON-INVASIVE VAGAL
NERVE STIMULATION WITH
STIMULATION OF THE VAGUS NERVE
USED DURING OPIOID WITHDRAWAL TO
MITIGATE SOME SYMPTOMS.
IT'S EXPECTED TO BLOCK SIM PA
PATH -- SYMPATHETIC RESPONSES
AND HAS BEEN SHOWN TO HAVE
CHANGES IN PATIENTS WITH ANXIETY
AND PTSD AND USED WITH A SHAM
CONTROL TO EVALUATE IT FOR
TREATMENT DURING THE FIRST TWO
WEEKS OF WITHDRAWAL.
THE MEASURES THAT WILL BE TAKEN
WILL INCLUDE SOME BRAIN IMAGING
AND ASSESS CRAVING AND LOOK AT
CARDIOVASCULAR AND INFLAMMATORY
MEASURES AS WELL.
THIS IS BEING CONDUCTED BY EMORY
UNIVERSITY.
LET ME MENTION ALL THESE
PIPELINES ARE SHOWN ON THE NIDA
WEB PAGE WITH HOT LINKS IN
REPORTER AND GO ON OUR WEB PAGE
AND CLICK ON THE LINK AND IT
WILL TAKE YOU THERE.
THIS IS A SUMMARY OF OUR
REGULATORY PROGRESS FOR OPIOID
USE DISORDER.
WE'RE VERY PROUD OF THE FACT
THAT SINCE THE BEGINNING OF THE
HEAL WORK WE HAVE BEEN ABLE TO
FILE 39 INDs.
I SAY WE FILED THEM PUT WE
WORKED WITH GRANTEES TO FILE
THEM.
THE TOTAL ACTIVE ARE 29.
AND SINCE OCTOBER WE HAVE FILED
TWO AND SEVEN INDs BECAME
ACTIVE.
FOR INVESTIGATIONAL DEVICE
EXEMPTIONS WHICH IS THE
REGULATORY PATHWAY FOR THE
ADVANCEMENT OF DEVICES, WE'VE
FILED A TOTAL OF TWO IDEs AND
HAVE A TOTAL OF ONE ACTIVE IED
AND SINCE OCTOBER OF '23, ONE
IDE WAS FILED AND ONE BECAME
ACTIVE.
WE HAVE TWO PROJECTS THAT HAVE
GOTTEN FAST-TRACK DESIGNATION
FROM THE FDA.
ONE AND WE HAVE A SOLUBLE
INHIBITOR THAT IS BEING
DEVELOPED FOR CHRONIC PAIN
DIABETIC NEUROPATHY AND A LEGAL
METHADONE FORMULATION THAT'S
BEING DEVELOPED AND THE ONE
BREAKTHROUGH THERAPY DESIGNATION
WHICH IS THE NEW FORMULATION FOR
OVERDOSE PROTECTION FOR THE
EFFECTIVE DELIVERY OF OXYCODONE
FOR PAIN USING THE MCAR
TECHNOLOGIES AND THERE'S ALSO
USING THESE TECHNOLOGIES FOR THE
DEVELOPMENT OF TREATMENT
MEDICATIONS FOR OUD.
AND THEN FINALLY IN THE PRE-NEW
DRUG APPLICATION STAGE WE HAVE A
FORM OF NALOXONE THAT IS ON
COTTON SWABS FOR THE REVERSAL
FOR OPIOID OVERDOSE AND IS OVER
THE COUNTER AND LOW COST.
THEY EXPECT THE PROJECT WILL
SELL FOR $10 A DOSE AND
AVAILABLE OVER THE COUNTER.
I THINK THAT IS MY LAST SLIDE.
I'M HAPPY TO TAKE ANY QUESTIONS
OR ANY FURTHER DISCUSSION.
I PROBABLY BLASTED THROUGH THAT
AND MADE UP SOME OF OUR TIME.
ANY QUESTIONS?
ALLAN YOU'RE ON MUTE.
>> THE QUESTION I HAVE IS A
GENERAL ONE AND SHAM CONTROL
WHEN YOU REFER TO VAGAL
STIMULATION.
AND YOU NEED A SLAM CONTROL IN
THESE PROCEDURES AND ALMOST
EVERY ONE OF THEM WILL PRODUCE
SOME RESPONSE TO THE INDIVIDUAL
WILL KNOW THEY'RE GETTING NOT TO
MENTION THE WHOLE DRAMA OF
HAVING THE PROCEDURE.
I'M CURIOUS HOW THAT'S DEALT
WITH.
IS THERE GENERAL SHAM CONTROL
THAT'S ACCEPTABLE?
>> THE SHAM CONTROL IS OBVIOUSLY
GOING TO VARY DEPENDING ON WHAT
THE TECHNOLOGY IS.
FOR THE SHAM CONTROL SAY FOR THE
DIRECT CURRENT STIMULATION I
THINK ALL THEY CAN DO IS HOOK
THE PERSON UP TO THE DEVICE AND
PRETEND THEY'RE DELIVERING IT TO
THE EXTENT THEY CAN BECAUSE I
DON'T KNOW THERE'S ANY ACTUAL
MARKER THAT IT'S BEING
ADMINISTERED THE PATIENT WOULD
BE AWARE OF.
IT'S OBVIOUSLY GOING TO VARY FOR
EACH TYPE OF TECHNOLOGY AND
DEVICE AND IT'S A CHALLENGE.
IT'S DEFINITELY A CHALLENGE.
>> THANK YOU.
WE'LL GO TO DR. NUNEZ AND THEN
TO THE COMMENTS.
>> JUST A COUPLE COMMENTS.
EXCITING TO SEE SO MANY INDUSTRY
PARTICIPATION IN THIS FIELD
WHICH WASN'T THE CASE EVEN A
DECADE AGO OR MORE AND EXCITING
TO SEE ALL THE DIFFERENT
INNOVATIVE APPROACHES
DEVELOPING.
ONE COMMENT WHICH I MAY HAVE
MADE BEFORE WITH THE LONG ACTING
IMPLANTS WHICH ARE REALLY
PROMISING APPROACHES, IT IS
IMPORTANT TO LOOK FOR THE
INTERINDIVIDUAL VARIATION.
FOR EXAMPLE, WITH JUST THE
VIVITROL INJECTION THERE'S MORE
INDIVIDUAL VARIATION THAN YOU
MIGHT THINK AND THERE ARE
PATIENTS WHO DON'T ABSORB THE
MEDICATION WELL AND HAVE
SUBTHERAPEUTIC LEVELS BY 21 DAYS
AFTER THE INJECTION.
IT'S IMPORTANT TO REALLY LOOK AT
THAT AS PART OF THESE PROJECTS.
>> THAT'S A REALLY IMPORTANT
CAVEAT.
GOING BACK TO THE INDUSTRY
INVOLVEMENT, WE HAVE BEEN VERY
WITH THE AMOUNT OF INDUSTRY
INVOLVEMENT WE'VE RECEIVED.
WE DO A LOT OF OUTREACH AND MEET
WITH COMPANIES THAT COME TO US
AND I THINK WHAT HAS REALLY MADE
THE DIFFERENCE IS THE FACT THAT
OUR TWO FLAGSHIP FUNDING
OPPORTUNITIES ACTUALLY OFFER
PEOPLE ENOUGH MONEY TO BE ABLE
TO DO DRUG DEVELOPMENT.
THE STANDARD RO1, $500,000 A
YEAR AND I KNOW WE SHOULDN'T
TALK ABOUT BUDGETS OR ANYTHING
ELSE IS NOT SUFFICIENT TO DO
DRUG DEVELOPMENT BUT THE AWARDS
ALLOW PEOPLE TO PROPOSE A
REASONABLE BUDGET TO GIVE THEM
ENOUGH TO COMPLETE IND ENABLING
STUDIES AND COMPLETE AT LEAST
PHASE I CLINICAL TRIALS AND
THAT'S MADE ALL THE DIFFERENCE.
>> IT'S AMAZING.
I AGREE IT'S AMAZING WHAT A
ROBUST INVESTMENT WILL DO.
>> THANK YOU SO MUCH.
LET ME QUICKLY GO TO THE
QUESTION THAT'S BEEN IN THE CHAT
A WHILE AND THEN GO BACK TO
HANDS.
THERE WAS A QUESTION ON
NON-INVASIVE VAGAL NERVE
STIMULATION AND HOW ARE
RESPONSES ASSESSED?
>> I'M NOT SURE HOW THAT'S GOING
TO BE DONE.
I'D HAVE TO GO BACK TO THE GRANT
AND HAVE A CLOSER LOOK.
>> NO PROBLEM.
THANK YOU.
I APPRECIATE THAT.
GALE, YOUR QUESTION.
>> I WANT TO FOLLOW-UP ON
SOMETHING YOU JUST TOUCHED.
ARE YOU GETTING THE GLP AGONIST
1 COMPANIES TO OFFER MEDICATION
FOR STUDIES?
>> ONE COMPANY DID OFFER ONE IN
THE ORIGINAL STUDY BUT FOR
REASONS I CAN'T REALLY EXPLAIN
OR UNDERSTAND, THEY DON'T SEEM
TO BE PROVIDING THEM TO ANYONE
FOR ANY SUBSTANCE ABUSE WORK AS
FAR AS I KNOW.
THEY ARE NOT PROVIDING THE SEMA
GLUTIDE FOR THIS STUDY.
>> THEY MAKE IT DIFFICULT.
IT'S SO EXPENSIVE.
IT'S A GREAT IDEA TRYING TO WORK
WITH MANY SUBSTANCES.
IF YOU HAVE MORE MONEY IN THAT
DIRECTION IT'S GOOD.
>> THEY HAVE MORE MONEY TO BUY
THE DRUG.
IT'S WHAT THEY HAVE TO DO.
>> THANK YOU.
>> WHAT THE COMPANY SAYS ARE
KEEPING IT IN COMMERCIAL DEMAND
IS WHAT THEY SAID.
>> THEY'RE ALSO INTERESTED IN
NEW INDICATIONS.
>> THERE'S A LOT GOING ON IN
THIS FIELD AND A LOT OF
POTENTIAL.
IT'S A FIELD JUST OFF THE
GROUND.
>> OKAY, ANY ADDITIONAL
QUESTIONS?
NO, WELL THANK YOU, SO MUCH THIS
WAS A GREAT TALK AND I
APPRECIATE ALL THE DISCUSSION.
>> THANK YOU.
>> SO, WITH THAT WE HAVE COME TO
THE END OF OUR OPEN SESSION.
I DON'T KNOW, WALTER, IF YOU
WANT ANY LAST WORDS FOR THE OPEN
SESSION BUT JUST A LITTLE BIT OF
HOUSEKEEPING.
WE'LL HAVE A BREAK UNTIL 3:00
P.M. AND INVITE THE MEMBERS AND
STAFF TO STAY ON THE ZOOM.
THIS IS STILL THE SAME ZOOM
YOU'LL BE USING FOR THE CLOSED
SESSION.
WE'LL JUST BE ENDING THE
VIDEOCAST PORTION.
>> I JUST WANT TO THANK
EVERYBODY FOR DOING THE WORK
BEHIND THE PRESENTATIONS.
DEMONSTRATE WHAT HEAL'S BEEN
ABLE TO DO WITH THE HELP FROM
EVERYBODY HERE ON THE CALL.
I WOULD SAY IF PEOPLE COULD --
WE'RE ALWAYS INTERESTED HOW TO
MAKE THESE MORE PRODUCTIVE,
VALUE-ADDED, SO IF YOU HAVE
SUGGESTIONS FOR FUTURE MDWG
MEETINGS THAT WOULD BE HELPFUL
AND FEEL FREE TO E-MAIL NORAH
AND MYSELF.
THANK YOU VERY MUCH AND WE'LL GO
TO CLOSED SESSION NOW.