THANK YOU, HELLO, I AM
DR. CANDACE TIN JEN. I WORK
WITH THE HUMAN AND HEALTH
DEVELOPMENT WHICH IS ONE OF THE
MANY INSTITUTES ON BEHALF OF THE
BRANCH I AM VERY EXCITED TO
WELCOME YOU ALL HERE. WE AROUND
700 REGISTRANTS SO CLEARLY AN
ITEM OF INTEREST GYNECOLOGIC
PAIN FOR OUR COMMUNITIES
SOMETHING WE KNOW THAT IS OFTEN
IGNORED OR GASLIT OR SOMETIMES
OVERLOOKED FOR A LOT OF OUR
POPULATIONS IN THE CLINIC, ET
CETERA, SO WE ARE REALLY HAPPY
TO BE HERE ABLE TO BE ABLE TO
PUT A SPOTLIGHT ON THIS AND I
WANT TO BE BRIEF SO WE CAN FOCUS
ON THE FANTASTIC AGENDA SO
DR. HELENA AUN HAS LED THE
CREATION OF THIS AGENDA WITH HER
PLANNING COMMITTEE SO WE THANK
THE COMMITTEE FOR THAT AND I
WANT TO SAY WE HAVE A REALLY
PACKED AGENDA. SO WE ARE GOING
TO TURN IT OVER TO ALL OF YOUR
OUR BRILLIANT SPEAKERS AND WE
WILL HAVE THE QUESTION AND
ANSWER IN THE CHAT AND OUR
MODERATORS WILL BRING THE
QUESTIONS TO THE SPEAKERS. SO
WITH THAT I WANT TO TURN IT OVER
TO OUR NICHD DEPUTY DIRECTOR
ALISON.
>> THANKS, FIRST OFF I WANT TO
ADD MY THANKS. TO SAY I'M SO
EXCITED, WE HAVE AN EXCELLENT
AGENDA TODAY. I PARTICULARLY
WOULD LIKE TO THANK THE GOING
K
GOING KOE LOGIC HEALTH AND
DISEASE BRANCH.
I ALSO WANT TO THANK ALL THE
PRESENTERS WHO ARE WILL BE TO
SHARE AND DISCUSS EMERGING
TRENDS WITHIN GEICO LOGIC PAIN
RESEARCH AND ALSO PARTICULARLY
GLAD THAT WE HAVE OUR COLLEAGUES
FROM THE U.S. FOOD AND DRUG
ADMINISTRATION FOR TAKING THE
TIME TO JOIN US TO DISCUSS FDA
REVIEW OF GYNECOLOGIC DEVICES
AND INVESTIGATIONAL NEW DRUG
PROCESSES AND ALSO THANK YOU TO
REPRESENTATIVES FROM TIGHT
LIPPED WHO ARE HERE TO PROVIDE
THE PATIENT PERSPECTIVE ON
CHRONIC PELVIC PAIN. THESE ARE
CRITICAL TO UNDERSTANDING OUR
ABILITY TO ADDRESS GOING KOE
LOGIC PAIN AND I THINK WE
NORMALIZE THIS SO MUCH. THAT
IT'S REALLY CRITICAL FOR US TO
UNDERSTAND THIS DOES NOT HAVE TO
BE NORMAL AND SOME OF THE
SIGNIFICANT IMPAIRMENTS THAT
PEOPLE DO FACE IN THE FACE OF
CHRONIC GOING KOE LOGIC PAIN SO,
YOU KNOW, WE REALLY ARE EXCITED
ABOUT THIS DISCUSSION TODAY. WE
HOPE WE ARE GOING TO MOVE THE
NEED. IT AFFECTS 26 MILLION
PEOPLE WORLDWIDE AND OFTEN
IGNORED. YOU KNOW, FOR MANY
PEOPLE THE PAIN IS SEVERE ENOUGH
FOR THEM TO MISS WORK OR SCHOOL
AND IT AFFECTS THEIR DAILY
LIVES. PAIN CAN BE
DEBILITATING, IT CAN HAVE
IMPACTS ON MENTAL HEALTH AND
QUALITY OF LIFE. AND REALLY THE
OTHER THING THAT I THINK CANDACE
MENTIONED IS, YOU KNOW, IN --
OFTENTIMES PEOPLE ARE TOLD WELL
IT'S JUST NORMAL. IT'S WHAT
HAPPENS. THERE'S A STIGMA, A
SOCIETAL NORMALIZATION AND THAT
PRESENTS A MAJOR BARRIER TO CARE
IF PEOPLE UNDERSTAND THAT IS NOT
NORMAL AND NEEDS ATTENTION. AND
DIAGNOSIS OF CONDITIONS THAT
CAUSE GYNECOLOGIC PAIN ARE OFTEN
DELAYED. CAUSE MANY PEOPLE TO
LIVE FOR YEARS WITHOUT
TREATMENT. AND ALSO AFFECTS
RESEARCHERS ABILITY. OUR
MISSION IS TO LEAD RESEARCH AND
TRAINING TO UNDERSTAND HUMAN
DEVELOPMENT, IMPROVE
REPRODUCTIVE HEALTH AND ENHANCE
THE LIVES OF CHILDREN AND
ADOLESCENTS AND OPTIMIZE
ABILITIES FOR ALL. ONE OF OUR
RESEARCH THEMES FOR OUR
STRATEGIC PLAN IS PROMOTING
GYNECOLOGIC ANDRO LODGE AND I
CAN REPRODUCTIVE HEALTH.
AND ONE OF OUR ASPIRATIONAL
GOALS IS REALLY SPECIFICALLY
TARGET AROUND THE DIAGNOSIS,
PREVENTION AND TREATMENT OF ENDO
KNOW TRIO SIS WHICH AFFECTS 10%
OF WOMEN IN THE U.S. JUST
WRAPPED UP IN THE MISSION AND
OUR STRATEGY AND YOUR GOALS WE
REALLY DO HAVE GYNECOLOGIC PAIN
BOTH AS A REPRODUCTIVE HEALTH
CONCERN.
BECAUSE SOME OF THE CONDITIONS
THAT CAUSE IT ARE LINKED TO
OTHER AREAS WHERE WE HAVE
PARTICULAR INTERESTS. BUT IT'S
ALSO REALLY CRITICAL, YOU KNOW,
NOT EVEN FOR REPRODUCTIVE HEALTH
BUT FOR THE DAILY LIVES. OF
PEOPLE WHO HAVE BEEN AFFECTED BY
THIS. BY ADOLESCENTS BY
REPRODUCTIVE AGE PEOPLE WHO ARE
AFFECTED AND EVEN INTO THE OLDER
AGES WE CONDUCT SUPPORTIVE
RESEARCH. WITH GYNECOLOGIC PAIN
AND FIBROIDS AND WE WORK WITH
THE PELVIC FLOOR DIAGNOSIS OF
CARE AND TREATMENT OF WOMEN WITH
PUBLIC FLOOR DISORDERS. WE
RECENTLY WORKED IN CALIFORNIA
THAT FOUND THAT A NONSTEROIDAL
ANTI-INFLAMMATORY DRUG WORKED IN
A RODENT MODEL OF ENDOMETRIOSIS.
THIS COULD BE PRESCRIBED MORE
FREQUENTLY FOR ENDOMETRIOSIS
PAIN. WE ALSO RECENTLY HELD A
PANEL DISCUSSION ABOUT ADVANCES
AND NEW DIRECTIONS IN ENDONE MEE
TRIO SIS. AND ADVOCACY
FOLLOWING A SCREENING OF THE
DOCUMENTARY BELOW THE BELT A
FILM BY DIRECTOR SHANNON KOEN
THAT THEN IS AVAILABLE ON OUR
NICHD WEBSITE WE HAVE RECENTLY
LAUNCHED AND HOPE TO BE REALLY
COMING OUT WITH MORE INFORMATION
ON SOON.
THE ADVANCING CURES AND
THERAPIES AND ENDING
ENDOMETRIOSIS DIAGNOSTIC DELAYS
INITIATIVE WE'RE GOING TO BE
PROVIDING ADDITIONAL INFORMATION
ABOUT THE RESEARCH OPPORTUNITIES
THAT WILL BE AVAILABLE,
HOPEFULLY VERY SOON. SO JUST IN
CLOSING, I WANT TO RESTATE OUR
COMMITMENT. AT NICHD TO
SUPPORTING HEALTH IN GYNECOLOGIC
PAIN RESEARCH. WE HAVE WORKED
WITH RESEARCHERS AND ADVOCATES
AND I THINK WITH YOUR HELP WE
CAN WORK TOGETHER TO BETTER
UNDERSTAND, AND TREAT
GYNECOLOGIC PAIN. I WANT TO
TURN IT TO DR. AUN BOTH WITH MY
THANKS, TO HER AND ALSO I'M
GOING TO TURN IT OVER TO HER TO
PROVIDE AN OVERVIEW OF THE
GYNECOLOGIC HEALTH AND DISEASE
BRANCH AND GYNECOLOGIC PAIN
PROGRAM AND THANK YOU AGAIN TO
ALL THE PRESENTERS I'M REALLY
LOOKING FORWARD TO THIS MEETING
AND HOPE EVERYONE ENJOYS IT. SO
DR. AUN. OVER TO YOU.
>> THANK YOU SO MUCH, DR.
THANK YOU
VERY MUCH FOR JOINING THE 2024
THIRD NICHD PAIN RESEARCH
VIRTUAL MIGHT. I AM A PROGRAM
OFFICER. I HAVE NO DISCLOSURE.
SINCE DR. CERTAIN ITCH MENTIONED
THE MISSION I WILL SKIP THIS.
AND SHE ALSO MANAGED THE
STRATEGIC PLAN. AND THE PLAN OF
2020 HAS FIVE THEMES. THE
SECOND THOOIM THEME IS PROMOTING
GYNECOLOGICAL AND ANDRO LOGICAL
AND REPRODUCTIVE HEALTH.
AND NICHD ALSO HAS ASPIRATIONAL
ROLES AND THE SECOND ONE OF THE
ASPIRATIONAL GOALS IS TO
DIAGNOSIS, PREVENT AND TREAT
ENDOMETRIOSIS WHICH IS ALSO
RELEVANT. AND NICHD DIVIDEND OF
EXMURAL RESEARCH HAS TWELVE
BRANCHES ONE OF THEM IS
GYNECOLOGIC HEALTH AND DISEASE
BRANCH. AND SGSHGSHDB AIM TO
IMPROVE WOMEN'S REPRODUCTIVE
HEALTH BY GUIDING AND SUPPORTING
GYNECOLOGIC RESEARCH AND CAREER
DEVELOPMENT PROGRAMS. AND GHDB
HAS HIGH PROGRAM PRIORITIES.
ONE OF THEM IS TO UNDERSTAND THE
MECHANISMS OF CHRONIC PAIN.
GHDB HAS THREE PROGRAMS THAT
CANDACE WHO HAS BEEN BEEN
OVERSEEING THE ENDOMETRIOSIS, AN
DINO MYOSIS, UNITED STATES RIN
FIBRO
FIBROIDS, MENSTRUATION AND
ENDOMETRIUM PORTFOLIOS AND
DR. M. WHO IS A MEDICAL OFFICER,
SHE HAS BEEN OVERSEEING THE
PELVIC FLOOR DISORDERS.
OBSTETRIC FISTULA AND FEMALE
GENITAL CUTTING PORTFOLIOS AND I
HAVE BEEN OVERSTEEG GYNECOLOGY
PAIN PORTFOLIO. WE RECENTLY
PUBLISHED INFORMATION.
PUBLISHED ON MARCH 18TH, 2024
THIS YEAR. IT'S ABOUT -- IT'S
ACT ENDO PROGRAM AND THE PURPOSE
OF THIS NOTICE SO ALERT THE
COMMUNITY THAT WE PLAN TO
PUBLISH RESEARCH OPPORTUNITY
ANNOUNCEMENT TO INVITE
APPLICATIONS FROM ELIGIBLE
ORGANIZATIONS TO ENGAGE WITH
NICHD TO DEVELOP, ADVANCE AND/OR
VALIDATE NEW DEVICES, BIOMARKERS
AND/OR METHODS OR REPURPOSE
EXISTING DEVICES FOR NONINVASIVE
DIAGNOSIS OF ENDO MEE TROE SIS.
IF YOU HAVE ANY SCIENTIFIC
QUESTIONS INQUIRIES PLEASE
CONTACT DR. TIN GENERAL IF YOU
GO TO THE GHDB WEBSITE YOU CAN
FIND MORE FUNDING OPPORTUNITIES.
THE APPLICATION UNDERSTANDING
CHRONIC CONDITIONS UNDERSTUDIED
AMONG WOMEN R 21 IS ON JUNE 2TH.
AND GHDB IS ALSO PARTICIPATING
IN THE HILL INITIATIVE OF
FUNDING OPPORTUNITIES. SO YOU
CAN PLEASE JEBBING THE
APPLICATION IN THREE DAYS AND IF
YOU GO TO THE HE'LL WEBSITE OR
YOU CAN FIND MORE DETAILED
INFORMATION. AND AND GHDB HAS
ALSO BEEN MANAGING THE BUILDING
IN WOMEN'S CAREER AND HEALTH.
GHDB HAD THE FIRST GYNECOLOGIC
PAIN VIRTUAL MEETING IN 2022 AND
SECOND MEETING IN 2023 LAST YEAR
AND THE GOAL OF THIS MEETING TO
BRING TOGETHER INVEST --
INVESTIGATORS TO DISCUSS
CHALLENGES, GAPS, AND DIRECTIONS
TO ADDRESS GYNECOLOGIC PAIN
RESEARCH. THIS WORKSHOP, THE
2023 WORKSHOP INVITED SEVEN
SCIENTIFIC SPEAKERS AND THREE
NIH SPEAKERS FROM HEAL AND SEED
AND THE 2023 WORKSHOP WAS
REGISTERED BY OVER 300 PEOPLE.
THE WORKSHOP PROVIDE
OPPORTUNITIES THAT INVESTIGATORS
COULD NETWORK AND COLLABORATE
TOGETHER. AND THIS IS THE THIRD
VIRTUAL PAIN MEETING AND THIS
MEETING WILL COVER THE MAIN
TOPICS RELATED TO GYNECOLOGIC
PAIN INCLUDING ENDOMETRIOSIS,
GYNECOLOGIC PAIN MANAGEMENT OR
TREATMENT AND FOR FDA
REGULATIONS AND GUIDELINES. AND
THEY WILL PROVIDE
AN OVERVIEW OF THE FDA TO HAVE A
VIEW OF GYNECOLOGICAL DEVICES
AND INVESTIGATIONAL NEW DRUG
PROCESSES AS OF THIS MORNING I
HEARD THAT OVER 600 PEOPLE
REGISTERED FOR THIS MEETING.
THIS MEETING IS BEING RECORDED
SO THE RECORDING WITH THE
SPEAKER'S APPROVAL WILL BE
POSTED AFTER THIS MEETING AND
THERE WILL BE A FIVE MINUTE Q&A
AFTER EACH TALK AND A DISCUSSION
SESSION AT THE END OF THE
MEETING. IF YOU HAVE ANY
QUESTIONS, PLEASE COMMIT YOUR
QUESTIONS USING THE Q&A BUTTON
ON THE ZOOM TOOLBAR. AND IF YOU
HAVE ANY TECHNICAL DIFFICULTIES
PLEASE CHAT THE HOST. AND I
WOULD LIKE TO HOST THE GHDB
PLANNING TEAM AND ALSO THE
NICHD.
WE WILL START WITH DR. EMILY
BARTLEY AN ASSISTANT PROFESSOR
IN THE DEPARTMENT OF COMMUNITY
DENTIST INDUSTRY AND BEHAVIOR
SCIENCE.
OR DIRECTOR OF COMMUNICATIONS
AND OUTREACH IN THE PAIN
RESEARCH AND INTERVENTION CENTER
OF EXCELLENCE. AT THE
UNIVERSITY OF FLORIDA. SO
DR. BARTLEY IS GOING TO BE
TALKING ABOUT INSIGHTS INTO
ENDOMETRIOSIS: UNRAVELLING THE
ROLE OF RISK AND RESILIENCE IN
PELVIC PAN -- PAIN AND IF YOU
HAVE QUESTIONS PLEASE PUT THEM
IN THE Q&A AND WE'LL ASK THEM
AFTER.
>> CAN YOU SEE EVERYTHING OKAY?
>> YES. EXCELLENT. HELLO, AND
GOOD AFTERNOON, I AM DELIGHTED
TO BE HERE TODAY TO SPEAK ABOUT
SOME OF OUR RECENT WORK THAT
WE'VE BEEN CONDUCTING IN PELVIC
PAIN IN PARTICULAR, EXPLORING
THE VULNERABILITY AND PROTECTIVE
FACTORS THAT ARE IMPLICATED IN
ENDOMETRIOSIS DISEASE BURDEN
BEFORE I START I HAVE NO
FINANCIAL DISCLOSURES AND MUCH
OF THE WORK THAT I'LL BE TALKING
ABOUT TODAY IS SUPPORTED BY AN R
21 GRANT FUNDED BY NICHD. FOR
OF THOSE WHO ARE UNFAMILIAR
ENDOMETRIOSIS IS AN ESTROGEN
DEPENDENT DISEASE. AND AFFECTS
MORE THAN ONE IN TEN WOMEN WHICH
EQUATES TO AROUND 4 MILLION
WOMEN IN THE UNITED STATES
ALONE. NOW BEYOND AN
INFERTILITY, PAIN IS THE
CARDINAL SYMPTOM OF
ENDOMETRIOSIS AND ONE OF THE
MAIN REASONS WHY WOMEN SEEK
HEALTH CARE I DO WANT TO POINT
OUT THAT PAIN DOESN'T JUST OCCUR
AT THE TIME OF MENSES,
ENDOMETRIOSIS IS ASSOCIATED WITH
A HOST OF OTHER PAIN SYMPTOMS
WHICH IS PAIN DURING DISCOURSE
AND A LARGE OF PORTION OF WOMEN
HAVE A GENERALIZED TYPE OF
PELVIC PAIN. THIS CAN BE LONG
AND FRUSTRATING ESPECIALLY SINCE
DIAGNOSIS CAN TAKE UP TO TEN
YEARS FROM THE ONSET OF
SYMPTOMS. WOMEN EXPERIENCE HIGH
RATES OF DEPRESSION AND POOR
QUALITY OF LIFE AND MUCH OF THIS
STEMS NOT ONLY FROM THE
UNPREDICTABILITY AND DEGREE OF
SYMPTOMS BUT ALSO FROM REPEATED
DISMISSAL FROM THE HEALTH CARE
SYSTEM. THIS IS A HIGHLY
STIGMATIZED CONDITION AND ALSO A
VERY DEBILITATING DISEASE AND
WHEN WE THINK ABOUT THIS FROM A
DISABILITY STANDPOINT, THE
IMPACT OF PAIN CAN BE QUITE
SIGNIFICANT. AND WE'VE EVEN
OBSERVED THIS IN OUR OWN DATA SO
WHAT YOU'RE SEEING HERE IS
SURVEY FINDINGS THAT WE
COLLECTED FROM 100 PEOPLE WITH
PELVIC PAIN. AND WE WERE
INTERESTED IN THE IMPACT OR THE
BURDEN THAT PELVIC PAIN HAS ON
DIFFERENT PARTS OF THEIR LIVES
SUCH AS THEIR ENERGY LEVELS OR
THEIR ABILITY TO GET A GOOD
NIGHT'S SLEEP OR EVEN FUNCTION
ADEQUATELY AT HOME OR AT WORK.
AND WHAT WE'VE FOUND IN THIS
DATA IS THAT AROUND 80% OF WOMEN
REPORT A MODERATE TO HIGH LEVEL
OF PELVIC PAIN IMPACT AGAIN
SUGGESTING THAT THIS IS A
DISEASE ASSOCIATED WITH
TREMENDOUS BURDEN AND WHEN WE
CONSIDER TREATMENTS, THERAPIES
TEND TO BE MORE PERIPHERALLY
BASED STARTING WITH THE
SUPPRESSION OF ESTROGEN LEVELS
AND THIS IS DONE MAINLY THROUGH
HORMONE CONTRACEPTIVES BUT OVER
50% OF WOMEN REPORT PERSISTENT
PAIN AFTER THERAPY ENDS AND FOR
THOSE WHO UNDERGO SURGERY SUCH
AS SURGICAL OBLATION UP TO 50%
HAVE PAIN RECURRENCE BUT
IMPORTANTLY THE STAGE OF
ENDOMETRIOSIS IS NOT REFLECTIVE
OF THE AMOUNT OF PAIN OR THE
DIVERSITY OF SYMPTOMS
EXPERIENCED BY PATIENTS YOU WILL
OFTEN FIND WOMEN WHO HAVE
MINIMAL OR MILD ENDOMETRIOSIS TO
HAVE A HIGH DEGREE OF PAIN. ON
THE OTHER HAND YOU'LL FIND
ASYMPTOMATIC WOMEN WITH SEVERE
ENDOMETRIOSIS BASED ON OBJECTIVE
FINDINGS. THE POINT I WANT TO
MAKE SURE IS THERE IS A HIGH
DEGREE OF VARIABILITY IN
CLINICAL SYMPTOMS AND IT MAY BE
THIS HETEROGENEITY IN THIS. SO
THIS HAS BEEN A GOAL THAT MY
COLLEAGUES AND I HAVE BEEN
WORKING ON IS TO BETTER
UNDERSTAND THE FACTORS THAT
CONTRIBUTE TO ENDOMETRIOSIS PAIN
AND ALSO HAVE A BETTER
UNDERSTANDING OF HIGH THESE
FACTORS SPECIFICALLY IMPACT
TREATMENT. SO THERE'S BEEN A
SMALL HANDFUL OF STUDIES IN
RESPONSE TO TREATMENT. THIS IS
AN EXAMPLE OF SOME OF THOSE
PREDICTORS BUT I WANT TO POINT
OUT THAT A LOT OF FACTORS LIKE
THESE ARE NOT OFTEN CONSIDERED
IN ROUTINE ASSESSMENT PRACTICES.
AND MANY STUDIES TEND TO REALLY
FOCUS ON SOCIODEMOGRAPHIC OR
CLINICAL PREDICTORS SO THIS HAS
BEEN A PARTICULAR FOCAL POINT
FOR US AND THAT'S REALLY TO KIND
OF MOVE BEYOND SOME OF THE MORE
TRADITIONAL FACTORS THAT HAVE
BEEN EXAMINED AND IDENTIFY
VARIOUS PSYCHOSOCIAL AND
BEHAVIORAL MECHANISMS THAT HAVE
BEEN RELATIVELY UNDEREXPLORED IN
THE ENDOMETRIOSIS DOMAIN.
BUT WHEN WE LOOK AT THE LARGER
PAIN LITERATURE, THESE ARE ALSO
FACTORS THAT HAVE RELIABLE
PREDICTABILITY IN ORDER TO
PREDICT CHRONIC PAIN AND
DISABILITY. I AM GOING TO SHOW
YOU SOME DATA THAT ILLUSTRATES
THE ASSOCIATIONS THAT WE HAVE
OBSERVED. THIS IS FROM OUR OWN
INTERNAL DATA. AND IT'S TAKEN
FROM A COMMUNITY-BASED SAMPLE
REPORTING ENDOMETRIOSIS AND WE
EXAMINE VARIOUS CHARACTERISTICS
ACROSS LEVELS OF PAIN IMPACT.
SO VARIOUS DEMOGRAPHIC,
BEHAVIORAL, AND PSYCH COLLEGE
CALENDAR CHARACTERISTICS WELLS,
THE QUALITY OF PAIN THAT WOMEN
EXPERIENCE. WHAT WE FOUND IS
THAT WOMEN WHO REPORT GREATER
PAIN IMPACT, SO THESE ARE WOMEN
WHO HAVE A HIGH DEGREE OF BURDEN
AND ACTIVITIES OF DAILY LIVING.
OR EVEN SOCIAL AND WORK
RELATIONSHIPS. ASSOCIATED WITH
THEIR PAIN HAVE A HIGHER BODY
MASS INDEX, REPORT GREATER
SYMPTOMS OF PAIN AND HIGHER
RATES OF SLEEP DISTURBANCE WHEN
YOU LOOK AT THIS FROM A
PSYCHOLOGICAL STANDPOINT THEY
ALSO REPORT A GREATER DEGREE OF
NEGATIVE PSYCHOLOGICAL
FUNCTIONING SUCH AS ANXIETY AND
DEPRESSION AS WELL AS LOWER
LEVELS OF PROTECTIVE RESOURCES
SUCH AS OPTIMISM. SO WHAT THESE
FINDINGS TELL US IS THAT THERE
ARE MULTIPLE FACTORS THAT VARY
WHICH MAY CONTRIBUTE TO
ALTERATIONS IN PAIN PROCESSING
THAT YOU SEE IN ENDOMETRIOSIS.
SO ANOTHER AREA THAT WE HAVE
BEEN EXPLORING IS THE PRESENCE
OF OVERLAPPING PAIN. AND IT'S
PROBABLY NO SURPRISE THAT
ENDOMETRIOSIS HAS A HIGH DEGREE
OF COPREVALENCE WITH OTHER PAIN
CONDITIONS IN PARTICULAR CHRONIC
OVERLAPPING CONDITIONS YOU MAY
HAVE HEARD THESE CALLS COPCS.
THESE REPRESENT A COLLECTION OF
TEN DISORDERS THAT OCCUR
FREQUENTLY IN THE POPULATION BUT
WHOSE UNDERLYING PATHOPHYSIOLOGY
REMAINS VERY POORLY UNDERSTOOD.
THESE CONDITIONS CONTAIN A HIGH
MORBIDITY. WHICH MEANS ONE
MEANS ANOTHER. A GREATER
PREVALENCE OF THESE CONDITIONS
IS ASSOCIATED WITH A HIGHER
FREQUENCY AND DURATION OF PELVIC
PAIN EPISODES. THEY'RE
ASSOCIATED WITH GREATER
ENDOMETRIOSIS PAIN SEVERITY AND
MORE FREQUENT DYSMENORRHEA AND
IMPAIRMENTS OF ACTIVITIES IN
DAILY LIVING. IN OUR OWN DATA
WE OBSERVE THAT WOMEN WHO HAVE A
GREATER NUMBER OF THESE SYMPTOMS
ALSO SELF-REPORT GREATER
SYMPTOMS OF CENTRAL
DECENTIIZATION. THAT
SENSITIVITY MAY PLAY A CENTRAL
ROLE.
WE HAVE TAKEN THIS A STEP
FURTHER AND EXAMINED HOW THIS IS
PELVIC PAIN BASED ON WHETHER OR
NOT ENDOMETRIOSIS IS PRESENT.
THIS IS BASED ON A SAMPLE OF 125
WOMEN WITH CHRONIC PAIN. 25% OF
HAVING REPORTED ENDOMETRIOSIS
AND WE CHARACTERIZED DIFFERENCES
IN PAIN BETWEEN THESE TWO GROUPS
AND EXAMINED THE INFLUENCE OF
COPCS ON PAIN. SO TO ORIENT
YOU, WOMEN WITH ENDOMETRIOSIS
ARE SIGNIFIED BY THE GOLD BAR
AND THE BAR IN BLUE REPRESENTS
WOMEN WHO HAVE CHRONIC PELVIC
PAIN BUT DO NOT HAVE
ENDOMETRIOSIS AND WHEN YOU
COMPARE THESE TWO GROUPS
TOGETHER. WOMEN WITH
ENDOMETRIOSIS REPORT
SIGNIFICANTLY GREATER LEVELS OF
PELVIC PAIN SEVERITY AND
INTERFERENCE FROM PAIN AND THEY
ALSO REPORT GREATER OVERALL PAIN
IMPACT. AND THESE WOMEN ALSO
HAVE A HIGHER PREVALENCE OF
COPCS AND IN PARTICULAR THEY
REPORT HIGHER RATES OF CHRONIC
FATIGUE SYNDROME, FIBROMYALGIA
AND TAN DO MANDIBULAR DISORDER
AND AROUND ONE QUARTER ALSO
REPORT THREE OR MORE OVERLAPPING
PAIN CONDITIONS.
AND THIS IS RELATIVE TO ONLY 12%
OF WOMEN WHO JUST STRICTLY HAVE
CHRONIC PAIN AND SO TAKING ALL
OF THIS TOGETHER, WHAT DID THIS
MEAN? I THINK FIRST WE NEED TO
KIND OF TAKE A STEP BACK AND ASK
OURSELVES WHY DO OUR CURRENT
TREATMENTS NOT WORK VERY WELL
FOR THIS CONDITION?
ENDOMETRIOSIS HAS BEEN
CHARACTERIZED AS HAVING THIS
MULTIFACTORIAL ETIOLOGY THAT NOT
ONLY INCLUDES PERIPHERAL
MODULATORS BUT MECHANISMS THAT
MONITOR PAIN AND IT COULD BE
THAT WE'RE MISSING CONTRIBUTOR
TO PAIN THAT ARE NOT OFTEN
CONSIDERED AND THIS IS
ESPECIALLY SALIENT GIVEN THE
DISCREPANCY BETWEEN SYMPTOM
SEVERITY AND DISEASE BURDEN.
THIS HAS BEEN THIS GROWING
INTEREST IN USING
MULTIDIMENSIONAL DATA TO SEE
DISEASE IN PATTERNS OF DISEASE
PRESENTATION AND COMORBIDITIES
WHICH COULD POTENTIALLY BE AN
AVENUE TOWARDS GREATER
PERSONALIZED MEDICINE. AND SO I
PUT A QUESTION MARK ON THIS
TITLE BECAUSE I THINK THIS IS AN
AREA THAT HOLDS A LOT OF PROMISE
BUT ALSO STILL IN ITS INFANCY
AND THERE'S STILL A LOT THAT WE
REALLY DON'T KNOW ABOUT THE
CHARACTERIZATION OF
ENDOMETRIOSIS. SO WE'VE
ACTUALLY BEEN TRYING TO TACKLE
THIS A LITTLE BIT. AND I WANT
TO BRIEFLY TOUCH UPON THE R21
STUDY THAT WE ARE CURRENTLY
CONDUCTING WHERE WE'VE BEEN
TRYING TO ADDRESS THIS ISSUE BY
EXPLORING PHENOTYPIC PREDICTORS
ASSOCIATED WITH PELVIC PAIN
IMPACT AND PHYSICAL FUNCTIONING
IN PATIENTS WHO HAVE CLINICALLY
SUSPECTED ENDOMETRIOSIS BUT WHO
ARE UNDERGOING CONSERVATIVE
MEDICAL MANAGEMENT OF THE
DISEASE AND WHAT WE'RE DOING IN
THIS STUDY IS WE'RE FOLLOWING
WOMEN FOR AROUND SIX MONTH TO
IDENTIFY WHETHER THERE ARE
SPECIFIC FACTORS THAT TEND TO
CLUSTER TOGETHER TO PREDICT HOW
WELL ONE DOES ON THESE TYPES OF
THERAPIES. INCLUDING HOW
PHENOTYPES WORK OVER TIME.
WE'RE WORKING ACROSS SEVERAL
BROAD DOMAINS SUCH AS YOU SEE
HERE AND ALTHOUGH THIS IS NOT AN
EXHAUSTIVE LIST THESE ARE SOME
EXAMPLES OF THE FACTORS THAT
WE'RE INTERESTED IN SUCH AS
VARIOUS DEMOGRAPHIC FACTORS,
HEALTH AND PAIN COMORBIDITIES.
SLEEP QUALITY, PSYCHOLOGICAL
RISK AND RESILIENCE FACTORS AS
WELL. NOW, WE'RE AT THE VERY
EARLY STAGE OF THE DATA
COLLECTION, BUT I WANTED TO
PROVIDE A SNAPSHOT OF WHAT WE'VE
BEEN FINDING SO FAR SO THESE ARE
DATA REPRESENTING PELVIC PAIN
IMPACT AND PHYSICAL FUNCTIONING.
AND DEPICT CHANGE IN THE OVERALL
COMBINED SAMPLE OVER THE SIX
MONTH PERIOD SO WHAT YOU'RE
SEEING HERE IS THAT THE SLOPE OF
THIS CHANGE IS NOT SIGNIFICANTLY
DIFFERENT FROM ZERO FOR EITHER
PAIN IMPACT OR PHYSICAL
FUNCTION. BUT WHAT'S
INTERESTING ABOUT THIS IS WHEN
YOU LOOK AT INDEPENDENT PAIN
SLOPES SIX MONTH CHANGE VARIES
DRAMATICALLY. THERE'S
IMPROVEMENTS OVER TIME IN THE
PAIN SYMPTOMS. SOME TEND TO BE
RELATIVELY STABLE OVER THE SIX
MONTH TIME COURSE. WHEREAS
OTHERS HAVE WORSENING
TRAJECTORIES, SO THEIR PAIN
IMPACT AND THEIR PHYSICAL
FUNCTION AND ACTUALLY GETS WORSE
OVER TIME. SO WHAT THIS
ILLUSTRATES IS THAT PATTERNS OF
CHANGE IN THESE SYMPTOMS VARY
AMONG ENDOMETRIOSIS PATIENTS
SUGGESTING THAT THERE IS A HIGH
DEGREE OF VARIABILITY IN PAIN
ASSOCIATED WITH TREATMENT. SO
TO KIND OF SUM UP EVERYTHING,
ENDOMETRIOSIS IS HIGHLY
HETEROGENOUS, NOT ONLY IN
PRESENTATION BUT ALSO IN
TREATMENT EFFICACY. AND WHILE
THIS DISEASE HAS PREDOMINANTLY
BEEN CONCEPTUALIZED A PERIPHERAL
CONDITION THERE'S OTHER THAN
PERIPHERAL DAMAGE: SO MOVING
FORWARD, IF WE THINK ABOUT, YOU
KNOW, HOW CAN WE IMPROVE OUR
UNDERSTANDING OF ENDOMETRIOSIS.
IT MAY BE THAT AN IMPORTANT
DIRECTIVE IS TO CONSIDER AND
IDENTIFY SOME OF THE
CHARACTERISTICS THAT PREDICT
THIS VARIABILITY BECAUSE THIS
MAY BE A REALLY CRITICAL STEP
TOWARDS INDIVIDUALIZING AND
IMPROVING PATIENT CARE FOR THIS
POPULATION. SO BEFORE I CLOSE I
WANT TO ACKNOWLEDGE MY
COLLABORATORS AND MY LAB AT THE
UNIVERSITY OF FLORIDA AND THE
ORLANDO VA. AS WELL AS NIH FOR
THEIR SUSTAINED SUPPORT
INCLUDING NICHD FOR FUNDING MUCH
OF THE WORK THAT I HAVE
DISCUSSED TODAY. THANK YOU.
>> THANK YOU SO MUCH,
DRDR. P
DR. BARTLEY, QUESTIONS CAN BE
PLACED IN THE Q&A TOOL. I
THOUGHT THIS WAS AN INTERESTING
TALK BECAUSE IT TALKS ABOUT THE
CONNECTION BETWEEN THE MIND AND
BODY. NOT ONLY JUST THE NEURONS
AND HOW THEY CONNECT TO THE
EXPERIENCE OF PAIN BUT ALSO HOW
THE EXPERIENCE OF PAIN CAN BE
DIFFERENT BASED ON THAT. I'M
WONDERING YOU BROUGHT IT UP ON
ONE SLIDE ABOUT DIAGNOSIS AND IT
MADE ME WONDER, IS THERE ANY
LITERATURE OUT THERE OR ANY DATA
ON THE EXPERIENCE OF PAIN PRE
AND POST-DIAGNOSIS? I'M
WONDERING IF BEING ABLE TO NAME
IT AND UNDERSTAND IT, IF THAT
CHANGES THE EXPERIENCE OF PAIN
FOR, SAY, ENDOMETRIOSIS?
>> LIKE ARE YOU ASKING, LIKE IS
THE, IS THAT CRITICAL TOWARDS
HOW A PATIENT KIND OF
UNDERSTANDS AND APPRECIATES, YOU
KNOW, HER PAIN EXPERIENCE AND
MOVING FORWARD?
>> YEAH, I WONDERED IF -- IF ANY
OF YOUR DATA OR THESE THINGS
LOOK AT WOMEN WITH PUNITIVE
ENDOMETRIOSIS RATHER THAN
DIAGNOSED ENDOMETRIOSIS AND
WOULD THERE BE DIFFERENCES THERE
BASED ON NOT REALLY KNOWING YET
THEIR DIAGNOSIS AND YET KNOWING
SOMETHING IS WRONG.
>> YEAH, ABSOLUTELY. YOU KNOW,
WE HAVE NOT LOOKED AT THAT IN
OUR OWN DATA BUT, YOU KNOW, I
THINK JUST KNOWING IS SO
INCREDIBLY IMPORTANT AND THE
FACT THAT THESE WOMEN HAVE TO GO
THROUGH YEARS OF SEEING MEDICAL
PROFESSIONAL AFTER MEDICAL
PROFESSIONAL AND NOT KNOWING
WHAT EXACTLY IS GOING ON I THINK
CAN BE VERY DETRIMENTAL TO
PSYCHOLOGICAL AND PHYSICAL
HEALTH AND MOST CERTAINLY IT
DOES IMPACT THE PAIN EXPERIENCE
IN SOME WAY AND WE KNOW THAT
THERE IS A HUGE LITERATURE ON
JUST HOW OUR BELIEFS, THE WAY
THAT WE THINK ABOUT THINGS, OUR
PSYCHOLOGICAL STATE CAN IMPACT
THE EXPERIENCE OVERALL AND JUST
BECAUSE IT IS A HIGHLY
STIGMATIZED CONDITION AND IF
YOU'RE NOT GETTING THAT
VALIDATION FROM OTHER PEOPLE, I
THINK CAN BE INCREDIBLY HARMFUL
SO I THINK SOMEBODY PUT THIS IN
THE CHAT AND I RESONATE WITH
THIS. I THINK IT'S SUCH AN
IMPORTANT STATEMENT THAT JUST
KNOWING THE DIAGNOSIS IS SO
INCREDIBLY HEALING.
>> AND CAN YOU SPEAK TO I THINK
SOME OF THE RISKS WERE REALLY
CLEAR, CAN YOU SPEAK TO SOME OF
THE RESILIENCE SOME OF THE
FACTORS THAT REALLY LEAD TO
RESILIENCE IN THE EXPERIENCE OF
PAI
PAIN?
>> YEAH, THIS IS AN AREA WE'RE
DIVING INTO AND WE LOOKED AT
PELVIC PAIN SEVERITY AND
DISABILITY IN THIS POPULATION.
WE SEE A LOT OF VARIOUS
PSYCHOSOCIAL FACTORS THAT ARE
ASSOCIATED WITH KIND OF LOWER
LEVELS OF DISABILITY. SO LIKE I
SHOWED YOU OPTIMISM BUT WE ALSO
LOOKED AT STRESS RESILIENCE
FROM, THERE'S JUST SOME VARIOUS
MEASURES THAT CAN EXAMINE THIS,
WE -- FROM THE RESILIENCE SCALE,
THERE'S ALSO THE PAIN RESILIENCE
SKILL THAT WE LOOKED AT. WE DO
SEE LOWER LEVELS OF THESE TYPES
OF FACTORS AS WELL BUT, YOU
KNOW, WHEN YOU THINK ABOUT
RESILIENCE YOU CAN KIND OF
CONCEPTUALIZE IT. FROM ACROSS
OTHER BEHAVIORAL FUNCTIONAL
TYPES OF CHARACTERISTICS. SO
PEOPLE WHO GET POOR SLEEP, YOU
KNOW, THAT IS GOING TO
ULTIMATELY HAVE A DETRIMENTAL
IMPACT ON PAIN AND BURDEN. SO
THIS IS AN AREA THAT WE'RE JUST
STARTING TO DIVE INTO. WE HAVE
FOUND THAT OUR CERTAIN KIND OF
PSYCHOLOGICAL RESILIENCE
CHARACTERISTICS THAT ARE
AFFILIATED WITH THE PAIN
EXPERIENCE. SO STAY TUNED.
>> AMAZING, THANK YOU. AND I'LL
NOTE THAT ONE OF OUR AUDIENCE
MEMBERS, ONE OF OUR RESEARCHES
IS NOTING THAT FOR THEIR
SUBPOPULATION THERE WASN'T A
DIFFERENCE BASED ON RACE AND SO
THIS MIGHT DIFFER BASED ON HOW
LARGE YOUR POPULATIONS ARE AND
WHICH EXACT POPULATIONS YOU'RE
LOOKING AT. EVEN MORE SPEAKS TO
YOUR POINT ABOUT REALLY
PERSONALIZING HOW WE THINK ABOUT
THIS.
>> YEAH, ABSOLUTELY, EVERYBODY'S
EXPERIENCE IS QUITE DIFFERENT
FROM ONE ANOTHER. YEP.
>> PERFECT. THANK YOU SO MUCH
DR. BARTLEY. I AM GOING TO ASK
THAT YOU MAYBE CONTINUE TO
ANSWER ANY QUESTIONS THAT POP UP
FOR YOU IN THE Q&A. AND -- BYLY
LET US MOVE ONTO OUR NEXT
SPEAKER, THANK YOU SO MUCH FOR
THAT TALK.
>> YEAH, THANK YOU.
>> SO OUR NEXT SPEAKER IS
DR. JAE AND JUST AS WE TALKED
ABOUT HOW SOME OF THE CURRENT
DRUGS ARE NOT SO HELPFUL AND
THERE'S A LARGE PERCENTAGE OF
THE POPULATION WHO STILL HAVE
PAIN AND STILL HAVE PROBLEMS
AFTERWARDS. THERE IS A LARGE
FOCUS ON DEVELOPING NEW
TREATMENTS FOR ENDO MEE TRIO
SIS. SO THERE'S AN
ANTI-INFLAMMATORY NANO DRUG FOR
TREATMENT.
>> THANK YOU FOR THE NICE
INTRODUCTION. WE ARE PERFORMING
THE NICHD PROGRAM AND WORK WITH
DR. DIANE TO DEVELOP THIS
ANTI-INFLAMMATORY DRUG FOR
ENDOMETRIOSIS. I THINK THE
DOCTOR GAVE A NICE PREVIEW OF
ENDOMETRIOSIS. THIS IS AN
ESTROGEN-DEPENDENT CHRONIC
INFLAMMATORY DISEASE
CHARACTERIZED BY THE PRESENCE OF
ENDOMETRIUM-LIKE TISSUE OUTSIDE
OF THE UTE USE. ONE IN TEN
REPRODUCTIVE AGE WOMAN,
WORLDWIDE ARE SUFFERING. THE
MAJOR SYSTEMS ARE THE CHRONIC
PELVIC PAIN AND THE INFERTILITY.
AND ONE OF THE USES HAVE
INCREASED THE LEVELS OF
PROINFLAMMATORY MEDIATORS IN
PERITONEAL FLUID, AND THE
ECTOPIC LESIONS AND THE UTOPIC
ENDOMETRIUM. AND THE
ANTI-INFLAMMATORY DRUGS ARE
SOMETIMES USED TO REDUCE PAIN.
SO WE ARE INTERESTED TO WHAT
KIND OF MOLECULES ARE INVOLVED
WITH THIS PROCESS. ONE, WE ARE
INTERESTED IN THE SIGNAL
TRANSDUCER AND ACTIVATOR OF THE
TRANSPORTATION THREE. GENERALLY
LOCATED IN THE SITE UNTIL
ACTIVATED BY THE
PHOSPHORYLATION. THERE'S A
VARIETY OF THE CYTOKINES SUCH AS
IL-6, IL-11 AND THE OTHER
ACTIVITY AND IT'S LOCATED TO THE
NUCLEUS AND THEN ACTIVATED
SEVERAL TRANSCRIPTION SO THE
PHOSPHORYLATED STAT3 IS RELATED
TO SEVERAL BIOLOGICAL FACTOR
INCLUDING ANGIOGENESIS,
IMMUNOSUPPRESSION, INFLAMMATION
AND CHRONIC PAIN. AFTER --
STAT3 ALSO AFFECTS THE
TRANSLATION AND THE EXPRESSION
OF IL-6, IL-1 BETA, TNF-ALPHA,
CCLT AND SOCS 3. FIRSTLY, IF
THERE'S THE DEVELOPMENT IN THE
HUMAN STEM WITH AND WITHOUT
ENDOMETRIOSIS.
AS YOU CAN SEE THE POSTTEST IS A
HIGH IN YOU TOPIC ENDOMETRIUM
FROM COMPARED TO THE CONTROL
WITHOUT ENDO -- ENDOMETRIOSIS XF
AND THEN WE WANT TO LOOK AT THE
ACTIVATION SO THE COLLABORATION
WITH THE DOCTOR ASK US AT THE
MICHIGAN STATE UNIVERSITY. HE
USED -- AND USES NONHUMAN
PRIMATE ENDO MEE 2R50E OWE SIS
MODEL THAT MIMICS THE
ELECTROGRADE TOD.
HE INOCULATE THE TISSUE TO THE
PERRY TEE ANYMORE AND THE ANIMAL
DEVELOPED ENDOMETRIOSIS. BEFORE
ENDO MEE 2R50E OWE SIS
INDUCTION, BUT AFTER INDUCTION,
IT VARIES QUICK. FIRST OF ALLY
INCREASING. WE ALSO USED THE
MOST MODEL FOR ENDO MEE TRIO SIS
STUDY AND THERE'S ACTIVATION OF
THE POST SIGNAL AFTER
ENDOMETRIOSIS INDUCTION SO OUR
HYPOTHESIS IS THIS PLAYS A
CRUCIAL ROLE IN CHRONIC PAIN.
AND POTENTIAL TARGET FIRST IS TO
DOWN REGULATE THE SIGNALLING
PATH WEI USING ANTIOXIDANT DRUG.
TO PROVE THIS HYPOTHESIS WE
DEVELOPED A PRECLINICAL MOUSE
USED IN THIS. AND THIS IS
SIMPLY THE MOUSE. WE HAVE THE
AUTOURINE THAT BECOME LOOSE. SO
IN USING THE BIOLUMINESCENCE IN
IN VIVO IMAGING WE CAN BASICALLY
DETECT THE UTERUS AND WE CAN
MAKE A 3D IMAGE OF THE UTERUS IN
THE LIVE ANIMAL AND ALSO THE --
IN ADDITION WE CAN USE THE
FLUORESCENCE MICROSCOPIC.
MICROSCOPE. WE CAN LOOK AT THIS
AND ALL OF THESE ARE IN GREEN
COLOR AND OTHER TISSUES ARE THE
LIGHTER COLOR. SO WE APPLY THE
SAME STANDARD SURGICAL INDUCTION
OF AN ENDO MEE TREATISE RELATED
TO THAT. AND INJECT THE TISSUE.
AND THEN THE -- FROM THE MOUSE
ARE SIMILAR TO THE HUMAN SO THE
ADVANTAGE IS THAT WE HAVE THIS
IMAGING. SO WE CAN CAN HAVE A
NONINVASIVE MONITORING OF THE
ENDOMETRIOSIS PROGRESSION IN
LIVE ANIMAL. AFTER WE -- THEY
USE -- WE USE THE GFP REPORTER
SYSTEM. IT'S LIVE VISUALIZATION
OF THE LESIONS. DETECTION IS
SEN SENSITIVE AND VERY FAST AND
IT'S POSSIBLE TO QUANTITATIVE
ANALYSIS.
YOU CAN SEE IT'S THE BRIGHT
FILLED IMAGE. THIS REGION CAN
DETECT A. SMALL ONE IS EVEN
DIFFICULT TO DETECT BUT YOU SEE
THIS FLUORESCENCE WE CAN DETECT
ALL THOSE SMALL ENDOMETRIOSIS
LESION. IF YOU LOOK AT THIS, WE
CAN REMOVE THIS REGION. MINIMAL
IMAGE OF THE NORMAL TISSUE TOO
SO YOU THINK THERE'S A MOUSE
THERE WE CAN HAVE A GOOD PLACE
TO STUDY THE ENDOMETRIOSIS AS
ASSOCIATED IN INFERTILITY AND IN
PAIN. AND ENDOMETRIOSIS IS
BASED ON THE MICE. SO WE HAVE
THE HUMAN. IF WE GIVE THE
ESTROGEN IN THE CONDITION THE
NUMBER IS SIMILAR TO AN INCREASE
COMPARED TO THE CONTROL AND THEN
WE HAVE THIS THAT IS LESS AND
THERE WE CHECK THE MAJOR SYMPTOM
OF THE HUMAN IN OUR ANIMAL
MODEL. PLUS THE SYMPTOM IS THE
INFERTILITY AFTER THE ENDO ME M
TRIO SIS WE CAN LOOK AT THE
ANIMAL WITH ENDSO ONE OF THE
MAJOR FOCUS IS THE
ENDOMETRIOSIS-RELATED PAIN IN
OUR ANIMAL MODEL. ENDOMETRIOSIS
IS A CHRONICEN FLAME STORY
CONDITION THAT CAUSES PAIN IN
THE PELVIS, ESPECIALLY DURING
MENSTRUAL PERIOD. THE LACK OF
PHARMACOLOGICAL TREATMENTS
SUITABLE FOR THE LONG-TERM
RELIEF OF
ENDOMETRIOSIS-ASSOCIATED PAIN
WITHOUT AN IMPACT OF FERTILITY.
PROGRESS HAS BEEN SLOWED BY THE
ABSENCE OF A REPRODUCIBLE ENDO
MEE THREE AGREE SIS MODEL THAT
FULLY REPLICATES HUMAN PATH SIZ
OWE LOGICAL CHARACTERISTICS
INCLUDING PAIN SYMPTOMS PAIN IS
USUALLY MEASURED TO WITH FLEX
AND NON REFLEX TESTING IN ANIMAL
MODEL THE REFLEX -- FOR THE
REFLEX TEST, A HYPERSENSITIVITY
IS EVALUATED BY APPLYING A
NOXIOUS STIMULUS BUT THIS
IGNORES THE ASSOCIATED EMOTIONAL
COMPONENT. WE USE THE NON
REFLEX TEST STUDY AND NON REFLEX
TEST INCLUDING THE BURROWING
TEST, MARBLE BURRING TEST AND
NESTING TEST. FOR THE BURROWING
TEST. THE MOUSE DILIGENTLY
TRIED TO TAKE OUT THE FOOD
OUTSIDE THE SICYLINDER. YOU CA
SAY THEY TAKE UP ALMOST ALL THE
PELLET. HOWEVER IN THE MOUSE
WITH THE ENDOMETRIOSIS, THE
WEIGHT BURROWED IS SNARNT
SIGNIFICANTLY REDUCED COMPARED.
THE SECOND TEST IS THE MARBLE
TEST WE PUT SEVERAL MARBLES IN
THE CAGE.
THEY TRY TO HIDE ALL THE MARBLES
INSIDE THE BEDDING. SO YOU CAN
SEE THIS AND THEN IF THEY HIDE
THE MARBLE COMPLETELY WE GIVE
THE HIGH SCORE. IF THEY DO NOT
TOUCH THE MARBLE WE GIVE THE
OTHER SCORE AND YOU CAN SEE IN
SHAM YOU SEE THE ORIGINAL NUMBER
AROUND NINE. BUT IN THE MOUSE
WITH THE ENDO THREE TRIO SIS THE
MARBLE SCORE IS SIGNIFICANTLY
REDUCED. AND LAST TEST IS THAT
NESTING TEST. FOR THE SMALLER
THEM, THE LAST IMPORTANT THING
HIT AS IN THE PRODUCTION. SO IF
YOU PUT THE NAP THAT THEY
GENERALLY MAKE. IF EACH
COMPLETE NESTING WE GIVE A SCORE
FIVE. IF IT'S INCOMPLETE WE
GIVE LOW SCORE IN THE SHAM
THOUGH YOU CAN SEE THE MOUSE
MAKE THIS. BUT MICE WITH ENDIS
LASTING SCORE IS A SIGNIFICANTLY
REDUCED SO THIS IS AN ENDO MEE
THREE I DIDN'T SAY AND THIS IS
RELATED TO THE PAIN.
A
IT HAS THE AND TO IF A SIT
ANYBODY. I MENTIONED THAT
THERE'S THIS. AND THIS IS
APPROVED WITH THE ELASTICITY FOR
THE ARTHRITIS. SO THIS YOU CAN
SEE THIS REDUCED THE LESION.
AND WE APPLY THE SAME IN OUR
ANIMAL MODEL. WE HAVE THE SAME
ORIGINAL TOOL. TO IF AS SIT
ANYBODY SHOWED REDUCTION IN
ENDOMETRIOSIS DEVELOPMENT.
HOWEVER THE PROBLEM OF SEVERAL
IS THE SYSTEM INSIDE THE FACTOR
SO WHAT -- FROM THAT, IT'S
KNOWING THE STAT IS IMPORTANT
FOR THE FUNCTION. ESPECIALLY
FOR ALL THE PREGNANCY. FROM THAT
IS IMPORTANT FOR THE FUNCTION.
ESPECIALLY FOR ALL THE
PREGNANCY. WHEN WE APPLY THE
THE TOFACITINIB INHIBITOR WE CAN
SEE THE IMPLANTATION IMPACTS.
IN THE VEHICLE YOU CAN SEE THE
NICE IMPLEMENTATION BUT THIS
INDIVIDUAL WITH THE TO IF A SIS
ANYBODY SHOWS A FAILURE.
BUT THIS WAS DUE TO THE SYSTEM,
MAYBE DUE TO THE SYSTEMIC
PRACTICE SO WE COLLABORATE. WE
DID THIS AT THE UNIVERSITY OF
MICHIGAN STATE UNIVERSITY. WE
APPLY A NANO PARTICLE EXPERT TO
PRODUCE A SYSTEMIC EFFECT FOR
TREATMENT OF THE ENDOMETRIOSIS.
NANO PARTICLE IS THE SMALL 1-100
NANO MOLECULE AND HAS A FUNCTION
OF THE PROPERTY AND PRODUCED THE
TARGETING TOXICITY AND CAN HAVE
THE THEY ARE RAH NOVEMBERSIC
PLASTICITY.
SO WHAT ARE WE PUTTING IN THIS
SIN NAP RATE TO THE TISSUE BUT
IT'S PENETRATED DUE TO THE
ANGIOGENIC ACCUMULATED TO THE
REGION. SO THE -- HERE APPLIED
THE THEY ARE RAN NOVEMBERSIC
NANO SYRIA HAS THE IMPACT AS
WELL AS NONINVASIVE IMAGING. SO
IF YOU GENERATED THIS HERE,
APPLIED THIS NAN PARTICLE TO
THIS AND HAVE THIS SWITCHING
MACROPHAGE FROM THE M 1
PROINFLAMMATORY AND TO THE OTHER
INFLAMMATORY STAGE AND ALSO POST
MRAS 'TIS SI LEVEL HAS DECRE
DECREASED.
WE CHECK THE TARGET AND WITH THE
DIAGNOSIS USING THE IMAGING.
THE DELIVERY FACTOR YOU CAN SEE
THE DRUG IS ACCUMULATED FOR ONLY
THE ECTOPIC LESION BUT NOT IN
THE UTOPIC. HOWEVER, IF THIS IS
NOT HARMFUL, SO NANO SYRIA, NOT
HALF OF THE IMPLEMENTATION AND
WE CHECK THE EFFECTIVENESS OF
THIS ENDO MEE TRIO SIS. AND WE
HAVE THE REGION USING THE
IMAGING.
AND AN ALSO LASTLY WE SHOULD
CHECK THE NANO SYRIA THAT
REDUCES THE NUMBER OF ECTOPIC
SITE COMPARED TO THE VEHICLE.
SON ALSO LASTLY WE SHOULD
CHECK THE NANO SYRIA THAT
REDUCES THE NUMBER OF ECTOPIC
SITE COMPARED TO THE VEHICLE.
ALSO LASTLY WE SHOULD CHECK
THE NANO SYRIA THAT REDUCES THE
NUMBER OF ECTOPIC SITE COMPARED
TO THE VEHICLALSO LASTLY WE SHO
THE NANO SYRIA THAT REDUCES THE
NUMBER OF ECTOPIC SITE COMPARED
TO THE VEHICLE. SO THE DATA
SHOWS THE ESTROGEN DEPENDENT
INFLAMMATION. THEY ARE
NOVEMBERSIC NANO SYRIA, A NOVEL
ANTIUP FLAMMATORY NAN PART KM
PROVIDES A PROMISING APPROACH
FOR ENDOMETRIOSIS TREATMENT.
NOW WE HAVE THIS ASSOCIATED WITH
PAIN. I WILL THANK YOU FOR OUR
MEMBERS, ALSO OUR COLLABORATOR,
DR. KIM AND NIHCD FUNDING.
OKAY, I STOP HERE. I'M HAPPY TO
TAKE QUESTIONS.
>> THANK YOU. THAT WAS A
FANTASTIC AMAZING FIFTEEN MINUTE
FORAY INTO THIS. MUCH OF OUR
AUDIENCE TODAY ARE NOT
RESEARCHERS BY TRAINING AND ARE
THE LAY PUBLIC SO I THINK BEING
ABLE TO SHOW THEM HOW WE CAN USE
A MOUSE MODEL AND ACTUALLY HAVE
THAT MOUSE MODEL LOOK LIKE IT
HAS ENDOMETRIOSIS AND LOOK AT
THE BEHAVIOR OF THESE MICE TO
DETECT WHAT LEVEL OF PAIN THEY
HAVE IS REALLY, REALLY
INTERESTING. BECAUSE I KNOW A
LOT OF OUR FOLKS WILL ASK HOW DO
YOU ASK HOW MUCH PAIN A MOUSE
HAS SO I THINK YOU SHOWING THE
BEHAVIORAL TEST.
>> I KNOW WE DON'T HAVE MUCH
MODEL ABOUT ENDO MEE 2R50E OWE
SIS ASSOCIATED PAIN.
SO THAT'S WHY IT'S DIFFICULT TO
DEVELOP THIS MODEL AND WE HAD
THE TEST AT SEVERAL DIFFERENT
METHOD. WE FINALLY FIND THE
MODEL. IT'S A MOUSE, IT'S
SIMPLE AND A HOMOGENEOUS ANIMAL
MODEL. EVEN WE GIVE IT USING
THE SAME AMOUNT, AT THE SAME
TIME, THAT -- THE IMPACT ARE.
DIFFICULT.
>> THERE'S INDIVIDUALISM.
>> THAT MEAN IT SHOULD NOT -- WE
DEVELOPED A MODEL BUT IT'S MORE
COMPLICATED.
>> RIGHT. RIGHT.
>> THAT'S WHY WE WANT TO MONITOR
THE VISION IN THE LIVE ANIMAL
AND THEN CHECK THE BEHAVIOR AND
LOOK AT THE CORRELATION.
>> YEAH. I MEAN, I THOUGHT --
THE PHENOMENAL POTENTIAL OF YOUR
WORK IS NOT ONLY A THERAPEUTIC
BUT THE DIAGNOSTIC POTENTIAL IS
INCREDIBLE WE'VE TALKED ABOUT
THIS TEN YEAR WE DELAY THE IDEA
THAT YOU CAN GO IN WITH AN
IMAGING AND SEE ENDOMETRIOSIS
LESIONS WOULD BE A GAME CHANGER
FOR DIAGNOSIS AND THAT'S
SOMETHING THAT YOU'RE WORKING
TOWARDS.
>> YES, THAT IS ONE OF THE
ADVANTAGE OF THE NANO PARTICLE.
THAT IS DOCTOR IS AN EXPERT FOR
THAT. IT'S WHERE APPLIED TO THE
FIELD. BUT IN OUR FIELD WE ARE
ONLY A FEW SCIENTISTS THAT THINK
ABOUT THAT CASE. I THINK -- AND
ENDOMETRIOSIS, YOU MENTIONED
IT'S BIOLOGIC. THERE ARE
SEVERAL IMAGING TOOLS. AND WE
DON'T HAVE THAT KIND OF POWER.
>> THE CANCER FIELD HAS
DEVELOPED THESE TOOLS BUT REALLY
THE LESIONS ARE VERY MUCH
CERTAIN KIND OF -- THEY BEHAVE
IN CERTAIN KINDS OF CONCERN.
THEY CAN METASTASIZE INTO
THINGS. OBVIOUSLY THEY ARE NOT
CANCEROUS BUT THEY CAN SOMETHING
THAT CAN BE UTILIZED IN THE SAME
SKILLS AND THE SAME TOOLS THAT
WE USE FOR CANCER BIOLOGY.
PHENOMENAL THAT YOU GUYS ARE
WORKING WITH THAT.
>> THAT'S WHAT WE ALWAYS SAY
IT'S UNDERSTUDIED, THE FIELD.
THER
THERE'S.
>> I THINK ASSIST ALL WE HAVE
TIME FOR BUT I KNOW WE WILL WANT
YOU TO COME BACK AS YOU HAVE
UPDATES BUT I AM SURE THAT
PEOPLE THAT ARE ENDOMETRIOSIS
AND ARE THINKING ABOUT SOME OF
THESE THERAPEUTICS WOULD LOVE TO
SEE SOME OF YOUR WORK HELP THE
WOMEN IN OUR AUDIENCE. WE WILL
NOW MOVE ONTO DR. LAURA PAYNE
WHO IS AN ASSISTANT PROFESSOR AT
HARVARD MEDICAL SCHOOL. SHE IS
ALSO THE DIRECTOR OF CLINICAL
AND TRANSLATIONAL PAIN RESEARCH
LAB. AT MCQUEEN HOSPITAL. AND
SHE'S GOING TO TALK TO US TODAY
ABOUT HOW MENSTRUAL PAIN BECOMES
CHRONIC PAIN. TAKE IT AWAY
DR. PAYNE.
>> YES, YOU WILL HEAR A LITTLE
BIT MORE ABOUT CENTRAL
SENSITIZATION FOR SURE ALTHOUGH
I'M GOING TO BE TALKING ABOUT A
DIFFERENT TYPE OF MENSTRUAL
PAIN. THAN ENDOMETRIOSIS
ASSOCIATED MENSTRUAL PAIN I WILL
SPEAK PRIMARILY ABOUT PRIMARY
DYSMENORRHEA AND THIS IS WITHOUT
ANY IDENTIFIED TISSUE PATHOLOGY.
SO IT'S A LITTLE BIT DIFFERENT
BUT CERTAINLY A LOT OF
SIMILARITIES. JUST A FEW
DISCLOSURES. SO MEN STRIEL
PAIN, WE GOT TO TALK ABOUT IT AS
IT WAS ELUDED TO EARLIER WE
DON'T TALK ENOUGH ABOUT PAIN
THAT GIRLS AND WOMEN EXPERIENCE.
IN PARTICULARLY MENSTRUAL PAIN.
MENSTRUAL PAIN IS A SIGNIFICANT
ISSUE FOR MANY REPRODUCTIVE AGE
GIRLS AND WOMEN IT AFFECTS UP TO
90% OF GIRLS AND WOMEN. AND
THIS IS A HUGE PART OF THE
POPULATION. AND 20-25% OF THIS
POPULATION EXPERIENCES SEVERE
AND DISABLING SYMPTOMS AND WHAT
THAT MEANS IS THAT CYCLE TO
CYCLE, WHICH IS ON AVERAGE EVERY
MONTH, THERE'S SIGNIFICANT
IMPAIRMENT IN DAILY ACTIVITIES
AND FUNCTIONING. IN PARTICULAR,
THIS IS IMPORTANT FOR
ADOLESCENTS. MORE RESEARCH HAS
REALLY LOOKED AT THE IMPACT OF
MENSTRUAL PAIN IN ADOLESCENT
POPULATIONS AND FOUND THAT
MENSTRUAL PAIN RESULTS IN
MISSING SCHOOL. IN MISSING
IMPORTANT ACTIVITIES INCLUDING
SPORTS, SOCIAL ACTIVITIES,
INTERFERING WITH DAILY
FUNCTIONING AND EVEN WHEN GIRLS
ARE ABLE TO GO TO SCHOOL, IT HAS
AN IMPACT ON THEIR ABILITY TO
CONCENTRATE AND FUNCTION IN
CLASS. SO IT'S A HUGE AND
SIGNIFICANT PUBLIC HEALTH ISSUE.
BUT HASN'T RECEIVED ENOUGH
ATTENTION AND ENOUGH RESEARCH.
BUT IF THIS ISN'T ALL CONCERNING
ENOUGH WE ALL KNOW THAT
MENSTRUAL PAIN IS A RISK FACTOR
FOR CHRONIC PAIN. THE MANY
CROSS-SECTIONAL STUDIES HAVE
SHOWN A STRONG POSITIVE
ASSOCIATED BETWEEN MENSTRUAL
PAIN AND CHRONIC PAIN A
WONDERFUL REVIEW AND
META-ANALYSIS BY DR. LEE AND
LESION IN 2020 SHOW THAT HAD
DYSMENORRHEA FOR MENSTRUAL PAIN
WAS ASSOCIATED WITH 2.5 TIMES
THE ODDS OF HAVING A CHRONIC
PAIN CONDITION.
SO DEFINITELY A STRONG
RELATIONSHIP THERE. BUT WE'VE
NEEDED TO LOOK MORE TEMPORALLY
TO SEE WHAT IS THIS DEVELOPMENT
OF CHRONIC PAIN LOOK LIKE IN
THIS POPULATION AND THERE'S BEEN
A NUMBER OF STUDIES IN ADULTS
THAT HAVE TRIED TO LOOK AT THIS.
SO HARDY AND COLLEAGUES
PUBLISHED A PAPER FROM A SAMPLE
OF 100 ADULT WOMEN WHO ARE
PRESENTING FOR CHRONIC PELVIC
PAIN AND THEY ASKED THEM
RETROSPECTIVELY DID YOU HAVE
MENSTRUAL PAIN AS A TEENAGER AND
WHEN DID THE PAIN DEVELOP AND
YOUR CHRONIC PAIN DEVELOP? AND
100% OF THESE WOMEN 45D HAD
MENSTRUAL PAIN AS YOUNG GIRLS.
FOR OVER HALF THE SAMPLE THIS
TRANSITION HAPPENED IN TWELVE
YEARS WHICH IS A RELATIVELY
SHORT TIME. IF YOU THINK ABOUT
IT, TWELVE YEARS IS REALLY ONLY
INTO THE MID-20S SO CERTAINLY A
CONCERNING TIME FOR THAT
TRANSITI
TRANSITION. LIVE AND COLLEAGUES
LOOKED AT ANOTHER STUDY LOOKING
AT 841 WOMEN. THEY FOUND THAT
THE PRESENCE OF DYSMENORRHEA AT
BASELINE WHICH WAS THE INITIAL
TIMEFRAME THESE SYMPTOMS WERE
REPORTED WAS ASSOCIATED WITH A
41% GREATER RISK OF DEVELOPING
CHRONIC PAIN TEN YEARS LATER SO
WE DEFINITELY SEE A RELATIONSHIP
HERE BUT WE JUST DON'T REALLY
UNDERSTAND WHY SOME OF THESE
INDIVIDUALS WHO HAVE MENSTRUAL
PAIN ARE GOING ONTO DEVELOP
CHRONIC PAIN. BUT OF COURSE A
LOT OF RESEARCH BOTH IN THE
MENSTRUAL PAIN AND THE CHRONIC
PAIN FIELD HAS LOOKED AT THIS
ROLE OF CENTRAL SENSITIZATION.
NOW CENTRAL SENSITIZATION
BASICALLY MEANS THAT THERE ARE
THESE LONG LASTING CHANGES IN
THE CENTRAL NERVOUS SYSTEM.
THAT AFFECT HOW PAIN IS
PROCESSED AND EXPERIENCED. AND
A LOT OF THIS WORK HAS LOOKED AT
BRAIN STRUCTURE AND FUNCTION.
IN CHRONIC PAIN AND IN HEALTHY
POPULATIONS AND SEEN DIFFERENCES
IN HOW INFORMATION IS PROCESSED.
AND SO THAT'S ONE WAY OF LOOKING
AT CENTRAL SENSITIZATION BUT
ANOTHER WAY THAT A LOT OF
RESEARCH HAS ALSO FOCUSED ON IS
SOMETHING CALLED QUANTITATIVE
SENSORY TESTING WHICH BASICALLY
MEANS JUST USING DIFFERENT
PAINFUL STIMULI TO PROVOKE PAIN
RESPONSES. AND SEE WHAT
PEOPLE'S LEVELS OF PAIN OR THEIR
TOLERANCE FOR PAIN IS. NOW
THESE DATA WERE FROM A REVIEW
THAT MYSELF AND MY TEAM DID THAT
WAS PUBLISHED IN 2017 WHERE WE
LOOKED AT ALL OF THE
EXPERIMENTAL PAIN FINDINGS IN
ADULT WOMEN WITH PRIMARY
DYSMENORRHEA COMPARED TO HEALTHY
CONTROLS. AND IN GENERAL, NOT
ENTIRELY CONSISTENTLY BUT IN
GENERAL ACROSS PAIN STIMULI,
ACROSS THE MENSTRUAL CYCLE AND
ACROSS DIFFERENT BODY LOCATIONS,
WOMEN WITH PRIMARY DYSMENORRHEA
EXPERIENCED GREATER PAIN
SENSITIVITY AND LOWER PAIN
TOLERANCE COMPARED TO HEALTHY
CONTROLS. AND SO ALTHOUGH MANY
OF THESE STUDIES AREN'T PERFECT
IT DOES SUGGEST THAT THERE ARE
THESE STABLE ALTERATIONS IN PAIN
PROCESSING THAT PERHAPS IS
CONTRIBUTING TO PAIN IN THIS
POPULATION. ONE OF THE AREAS OF
RESEARCH THAT IS MY AREA OF
RESEARCH AND ONE OF THE THINGS
THAT WE WANTED TO LOOK AT IS DO
WE SEE THESE FINDINGS IN
ADOLESCENT POPULATIONS. THIS IS
A PAPER THAT WAS PUBLISHED IN
219 AND IN THIS SAMPLE IT WAS
GIRLS AGES 6-25 AND WE DID
SEVERAL DIFFERENT TYPE OF PAIN
TESTING PARADIGM TO SEE THEIR
PAIN RESPONSES.
SO ON THE LEFT YOU'LL SEE THIS
WAS THEIR -- THE AMOUNT OF TIME
THAT THEY WERE TABLE KEEP THEIR
HAND IN COLD WATER. THIS IS A
VERY COMMON QUANTITATIVE SENSORY
TESTING PARADIGM AND IN THIS
SAMPLE ACROSS THE MENSTRUAL
CYCLE GIRLS WITH PRIMARY
DYSMENORRHEA HAD A LOWER PAIN
TOLERANCE COMPARED TO GIRLS THAT
WERE IN THE CONTROL GROUP. SO,
AGAIN, THIS SUGGESTS WE SEE SOME
OF THESE ALTERATIONS EVEN IN
YOUNGER POPULATION. NOW WE ALSO
DID ANOTHER PARADIGM SOMETHING
CALLED OPINIONED PAIN MODULATION
AND THIS IS A DIFFERENT TYPE OF
TESTING PARADIGM MEANT TO ASSESS
THESE DESCENDING PAIN INHIBITION
IN THE BRAIN AND THE CENTRAL
NERVOUS SYSTEM AND WHAT IS
DIFFERENT IS THERE WAS NO GROUP
DIFFERENCES IN THIS PARTICULAR
PAIN PARADIGM. THERE ARE SOME
DATA SUGGESTING THERE'S ENHANCED
PAIN SENSITIVITY. BUT SOME OF
THESE OTHER PARADIGMS, THAT ARE
PRETTY WIDELY USED IN CHRONIC
PAIN POPULATIONS, WE DID NOT
FIND EVIDENCE OF THAT. IN
ADOLESCENTS IN YOUNG ADULTS WITH
PRIMARY DYSMENORRHEA. SO WHAT
REALLY INTERESTING EMERGENT
RESEARCH THAT WE'RE STARTING TO
LOOK AT IS FROM A BROADER
PERSPECTIVE AND A NUMBER OF MY
COLLEAGUES ARE GOING SOME WORK
IN THIS AREA AND THIS HAS BEEN
LOOKED AT IN MORE CHRONIC PAIN
POPULATIONS BUT THIS IS TAKING
CENTRAL SENSATION AND THIS IS
LOOKING AT ALL SENSITIVITY TO
OTHER SENSORY STIMULI INCLUDING
LIGHT, SOUND, HEAT, COLD, SMELL,
TOUCH, TASTE AND EVEN ALLERGIES.
THIS IS REALLY EXPANDING BEYOND
JUST WHAT WE HAVE TYPICALLY USED
IN OUR PAIN TESTING PARADIGMS
AND PERHAPS IS GOING TO GIVE US
SOME ADDITIONAL CLUES INTO WHO
IS REALLY AT RISK FOR DEVELOPING
CHRONIC PAIN BECAUSE OF THIS
CENTRAL SENSITIZATION. NOW MY
COLLEAGUES DR. KEVIN HELLMAN
DEVELOPED A PAPER LOOKING AT
THIS IDEA OF MULTIMODAL HYPER
SENSITIVITY. THESE WERE FROM A
SAMPLE OF TWO HUNDRED YOUNG
ADULT WOMEN. THAT HAD EITHER
MENSTRUAL PAIN, BLADDER PAIN
SYNDROME, OR A NON PELVIC
CHRONIC PAIN.
AND THEY WENT THROUGH A SERIES
OF DIFFERENT TESTING PARADIGMS.
AND ULTIMATELY PUT TOGETHER A
COMPOSITE MEASURE. WHAT THEY
CALL MULTIMODAL HYPERSENSITIVITY
THAT INVOLVE SENSITIVITY TO
AUDITORY, VISUAL AND SOME PAIN
STIMULI AND PUTTING TOGETHER
THIS COMPOSITE MEASURE WAS
ACTUALLY THE BEST PREDICTOR OF
PELVIC PAIN FOUR YEARS LATER
EVEN BETTER PREDICTOR THAN THEIR
BASELINE LEVEL OF PELVIC PAIN AS
WELL AS PRESSURE PAIN THRESHOLDS
AND BLADDER HYPERSENSITIVITY.
SO IT REALLY SUGGESTS THIS
BROADER PERSPECTIVE MIGHT BE
ACTUALLY A BETTER PREDICTOR OF
WHO IS ACTUALLY GOING TO DEVELOP
CHRONIC PAIN. AND SO WE HAVE
STARTED TO LOOK AT THIS IN MY
CURRENT STUDY. SO IN THIS
STUDY, THAT IS ONGOING, ALTHOUGH
WE HAVE COLLECTED MUCH OF THE
DATA, IT'S 141 ADOLESCENT GIRLS
AGES 13-19 AND THE STUDY
INCLUDED INDIVIDUALS WITH A
RANGE OF MENSTRUAL PAIN SEVERITY
LEVELS SO WE INCLUDED GIRLS THAT
HAD MILD PAIN ALL THE WAY TO
SEVERE PAIN AND WHAT IS
IMPORTANT ABOUT THIS POPULATION
NOT JUST THAT THEY'RE
ADOLESCENTS AND KIND OF IN THE
EARLIER STAGES OF THIS
DEVELOPMENT IS THAT WE EXCLUDED
ANYBODY WITH ANY TYPE OF CHRONIC
PAIN CONDITION. SO THIS IS A
VERY COMMUNITY-BASED SAMPLE OF
TYPICAL ADOLESCENT WITH
MENSTRUAL PAIN WE ALSO EXCLUDE
INDIVIDUALS WITH MAJOR
PSYCHIATRIC ISSUES AND THAT IS
BECAUSE OF THE STUDY INCLUDED AN
SMRI COMPONENT. FOR THE DATA
I'M PRESENTING TODAY THEY WERE
ASSESSED AT BASELINE AS WELL AS
MONTHLY FOR 12 MONTHS AND THE
MEASURES WE USED WE USED A
SELF-REPORT MEASURE CALLED THE
HYPERSENSITIVITY SCALE. AND
SPLIT THEM INTO TWO GROUPS HIGH
VERSUS LOW AND LOOKED AT THE
SEVERITY TRAJECTORY OVER 12
MONTHS AND THEN THE PRIMARY
OUTCOME WAS THIS MEASURE OF PAIN
WIDESPREADNESS TRAJECTORY. NOW
PAIN WIDESPREADNESS WAS DEFINED
AS THE NUMBER OF LOCATIONS ON
THEIR BOD THEY THAT THEY
ENDORSED AS PAINFUL IN THE PAST
MONTH. WE USE THIS BODY MAP
WHICH YOU CAN SEE THERE FROM THE
STUDY AND WE ADDED UP THE NUMBER
OF BODY PAIN LOCATIONS THAT THEY
WERE ENDORSING NOW THE REASON
THAT THIS IS IMPORTANT IS
BECAUSE MOST GIRLS AT THIS AGE
WILL NOT HAVE DEVELOPED CHRONIC
PAIN BUT THIS PAIN
WIDESPREADNESS IS A PROXY FOR
CHRONIC PAIN. THE EXTENT OF THE
PAIN WIDESPREADNESS IS
ASSOCIATED WITH MANY CHRONIC
PAIN CONDITIONS THAT ALLOWS US
TO SEE WHO ARE AT MUCH GREATER
RISK FOR CHRONIC PAIN AND WHEN
WE LOOKED AT DIFFERENT GROUPS,
WHICH I'LL BE PRESENTING IN JUST
A MOMENT, WE FOUND THAT OF THE
SAMPLE, 80 WERE GROUPED INTO THE
GROUP THAT SHOWED NO INCREASE IN
MENSTRUAL PAIN OVER TWELVE
MONTHS IT EITHER STAYED THE SAME
OR WENT DOWN AND 61 IN A GRIPE
GROUP SHOWED AN INCREASE IN
TWELVE MONTHS.
AND SO WHAT WE FOUND WAS THAT
FOR THE GROUP THAT SHOWED NO
INCREASE IN MENSTRUAL PAIN, OVER
THE TWELVE MONTHS, THE NUMBER OF
BODY PAIN LOCATIONS THAT THEY
ENDORSED GENERALLY WENT DOWN.
BUT IF YOU HAD HIGH SENSORY
HYPERSENSITIVITY, YOU STILL HAD
MORE BODY PAIN LOCATIONS THAN
THE LOW GROUP. SO YOU'RE STILL
AT A GREATER RISK FOR CHRONIC
PAIN. BUT IF YOU LOOKED AT THE
GROUP THAT SHOWED AN INCREASE
OTHER THE TWELVE MONTHS, IF YOU
HAD HIGH SENSORY
HYPERSENSITIVITY THE NUMBER OF
BODY PAIN LOCATIONS THAT YOU
WERE ENDORSING WENT UP
SIGNIFICANTLY. SO THIS REALLY
SHOWS THAT THIS GROUP IS THE
POTENTIAL GROUP AT GREATEST RISK
FOR CHRONIC PAIN. THOSE WHO
HAVE AN INCREASE IN MENSTRUAL
PAIN AS WELL AS THOSE WITH
MULTISENSORY SENSITIVITY. WE
NEED TO THINK OUTSIDE THE BOX OR
OUTSIDE THE UTERUS. PAIN
SENSITIVITY IS ONE ASPECT OF
THIS AND ALTHOUGH I THINK MANY
OF US HAVE KNOWN THIS, WE
HAVEN'T REALLY IMPLEMENTED THIS
INTO OUR RESEARCH PROTOCOLS.
AND PERHAPS (NO AUDIO) LEAD TO
CHRONIC PAIN. THE EVIDENCE IS
VERY COMPELLING. IN MY OPINION.
THIS TYPE OF CONSTRUCT HAS BEEN
STUDIED IN CHRONIC PAIN
SYNDROMES FOR AWHILE BUT PERHAPS
WE CAN ACTUALLY IDENTIFY THIS --
THESE ALTERATIONS AND SENSORY
PROCESSING, MUCH EARLIER ON.
AND BE ABLE TO ADDRESS THESE
SYMPTOMS IN ORDER TO PREVENT THE
DEVELOPMENT OF CHRONIC PAIN. WE
NEED MORE LONGITUDINAL STUDIES
ON MAN MENSTRUAL PAIN TO BETTER
CHARACTERIZE THESE FACTORS.
BUT THIS BROADER PERSPECTIVE
OPENS UP THE POSSIBILITY OF
NEWER TREATMENT APPROACHES
IDEALLY TO REDUCE MULTISENSORY
SENSITIVITY THROUGH BEHAVIORAL
STRATEGIES, OR MEDICATION OR
OTHER TREATMENTS BASED ON
MECHANISMS INVOLVED IN THIS TO
IDEALLY PREVENT THE PAIN. SO I
JUST WOULD LIKE TO ACKNOWLEDGE
MY TEAM AT MCLANE HOSPITAL AND
AS WELL AS THE ONGOING GRANT
SUPPORT FROM NICHD. THANK YOU
SO MUCH.
>> THANK YOU SO MUCH DR. PAYNE.
I -- AM MIND BLOWN OVER HERE I
NEVER WOULD HAVE THOUGHT AS
MITCH AS I ALREADY WORK IN THIS
FIELD AND KNOW ABOUT PELVIC PAIN
I NEVER WOULD HAVE THOUGHT ONE
OF THE BEST PREDICTORS WAS
INCLUDING SENSITIVITY TO LIGHT
AND SENSITIVITY TO SOUND AS A --
AS A PREDICTOR OF PELVIC PAIN OR
MENSTRUAL PAIN THAT IS, YOU
KNOW, I DON'T THINK IT IS
SOMETHING WE THINK OF SO THAT'S
INCREDIBLE. AND I THINK THE
AUDIENCE IS THINKING THE SAME
THING THAT I AM WHICH IS NOW
THAT WE KNOW THIS, HOW DO WE
REALLY USE THIS? HAVE YOU SEEN
THIS CHANGE THERE GUIDELINES?
IS ANYBODY USING MMH IN THE
CLINIC TO START TO HELP PEOPLE?
>> I DON'T THINK IT HAS
TRANSLATED TO CLINICAL WORK JUST
YET. I KNOW MY COLLEAGUES
DR. HELLMAN ARE DOING A LOT OF
WORK IN THIS AREA, SOME REALLY
GROUND BREAKING WORK AND ANOTHER
DOCTOR AS WELL. BUT I THINK
THIS IS JUST A REALLY
FASCINATING AREA THAT REALLY
SPEAKS TO THE ROLE OF THE BRAIN
AND CENTRAL SENSITIZATION BUT
PERHAPS PART OF WHAT HAS BEEN
CONFUSING IN THE LITERATURE THUS
FAR PARTICULARLY WITH MENSTRUAL
PAIN IS IT HAS BEEN SUCH A
NARROW FOCUS AND I THINK THAT I
SEE THIS AS KIND OF THE NEXT
AREA THAT WE REALLY NEED TO
INVESTIGATE. SO MY LAB IS KIND
OF WORKING AT, LIKE, THINKING
ABOUT WHAT ARE THE MECHANISMS
AND WE'RE CONSIDERING DIFFERENT
THINGS INCLUDING ALTERATIONS IN
THE GUT MICROBIOME BECAUSE THAT
IS A FACTOR THAT WE KNOW IS
ASSOCIATED WITH HYPERSENSITIVITY
IN OTHER AREAS TOO AND THIS
PERHAPS COULD BE ONE OF THE
THINGS INVOLVED.
>> THAT'S INCREDIBLE. I MEAN IT
SOUNDS LIKE TO ME THEN IF I WAS
A PATIENT WITH MENSTRUAL PAIN OR
PELVIC PAIN AND I ALSO HAD THESE
OTHER HYPERSENSITIVITIES THAT IS
SOMETHING I CAN BRING UP WITH MY
CLINICIAN AND MAKE IT KNOWN TO
THEM I HAVE OTHER STUFF GOING
ON.
>> YES THAT COULD BE A RISK
FACTOR. I'M A PSYCHOLOGIST AND
I COME FROM A BEHAVIORAL
PERSPECTIVE BUT THERE ARE A FEW
PAPERS PUBLISHED ON REDUCING
THIS MORE WIDESPREAD SENSORY
SENSITIVITY WITH BEHAVIORAL
STRATEGIES AND SO THERE'S A LOT
OF POSSIBILITY HERE.
>> REALLY TRYING TO GET AHEAD OF
THAT CENTRAL SENSITIZATION SO
YOU STOP IT BEFORE IT BECOMES A
BODY WIDE PROBLEM. THAT'S
INCREDIBLE. THANK YOU SO MUCH,
DR. PAYNE, THANK YOU FOR YOUR
WORK, ESPECIALLY IN THE
ADOLESCENCE FIELD. GETTING
AHEAD OF THIS PAIN AND
UNDERSTANDING IT WHEN GIRLS AND
WOMEN ARE YOUNG. AND WE CAN
REALLY TRY TO PREVENT SOME OF
THE PAIN BEFORE WE EVEN HAVE TO
TREAT IT IS SO, SO KEY. SO WE
ARE GOING TO MOVE ON NOW TO OUR
NEXT SPEAKER. WE HAVE HAD
SEVERAL QUESTIONS IN THE CHAT
ABOUT THERAPEUTICS SO I AM JUST
GOING TO HAVE DR. GOLD STEIN
ANSWER ALL OF THEM BUT DR. GOLD
STEIN IS THE DIRECTOR OF THE
CENTERS FOR VAGINAL DISORDERS
AND WILL SPEAK ABOUT A RECENT
SUMMIT AND TELL US ABOUT WHAT
WENT ON THAT MEETING.
>> THANK YOU VERY MUCH. I WANT
TO THANK YOU FOR HAVING ME
DR. AUN AND INVITING ME FOR THIS
VERY IMPORTANT MEETING AS I H
HEAR -- SIT HERE AND LISTEN I
CAN'T BE BY ENVIOUS OF THE WORK
THAT IS GOING ON IN THE WORLD OF
ENDOMETRIOSIS AND HOW FAR ALONG
THEY ARE COMPARED TO HOW FAR
ALONG WE ARE WITH THERAPEUTICS
IN AS A RULE VOE DIN YA. SO
THIS KIND OF MEETING THAT I'M
GOING TO TALK ABOUT IS BASICALLY
TO MOVE US TOWARDS TREATMENT.
MY MAIN RELEVANT DISCLOSURE IS
THAT I AM THE PRESIDENT OF THE
GYNECOLOGIC CANCERS RESEARCH
FOUNDATION WHICH IS ONE OF THE
FOUR SPONSORS OF THIS MEETING
THAT WE RECENTLY HAD. E PRESIDEC
CANCERS RESEARCH FOUNDATION
WHICH IS ONE OF THE FOUR
SPONSORS OF THIS MEETING THAT WE
RECENTLY HAD. SO THE CONCEPTION
OF THIS RESEARCH SUMMIT WAS THAT
APPROXIMATELY NINE YEARS AGO
ISSVD, ISSWSH CAME TOGETHER TO
PUBLISH AND DEVELOP THE
VULVODYNIA NOMENCLATURE. ONE OF
THE MOST IMPORTANT STATEMENTS
WAS THAT TREATMENT IS SHOULD BE
CHOSEN ACCORDING TO THE
CHARACTERISTICS OF THE
INDIVIDUAL CASE AND A POSSIBLE
ASSOCIATED FACTORS RATHER THAN A
ONE SIZE FITS ALL APPROACH TO
THE TREATMENT OF VULVAR PAIN OR
VULVODYNIA. UNFORTUNATELY AS
MANY OF YOU ARE ALL TOO WELL
AWARE THE EFFORT TO DEVELOP NEW
THERAPIES FOR VULVODYNIA HAS NOT
MOVED FORWARD IN ANY SIGNIFICANT
WAY HOWEVER RESEARCH HAS MADE
PROGRESS IN IDENTIFYING TARGETED
PATH -- PATH WEIS.
WE CON ACCEPT CHILDIZED A SUMMIT
TO LOOK AT TREATMENTS FOR
VULVODYNIA BASED ON OUR CURRENT
SUNS UNDERSTANDING OF THE
PATHOPHYSIOLOGY OF VULVA DIN YA.
WE WANTED TO DEVELOP AN AS IS
CONSENSUS AMONG PARTICIPANTS AS
TO WHEN ARE THE MOST PROMISING
AND FEASIBLE OF THESE NOVEL
IDEAS AND TO PRODUCE A WHITE
PAPER OR SIMILAR DOCUMENT THAT
COULD BE PRESENTED TO POTENTIAL
FUNDING ORGANIZATIONS INCLUDING
BUT NOT LIMITED TO NICHD, OTHER
GOVERNMENTAL AGENCIES, LARGE
PRIVATE FOUNDATION THAT CARE
ABOUT WOMEN'S HEALTH, PHARMA,
AS -- BECAUSE THERE'S VERY
LITTLE INTEREST IN THE
PHARMACEUTICAL INDUSTRY ABOUT
VULVODYNIA AS WELL AS OTHER
POTENTIAL STAKEHOLDER SOCIETIES.
SO THE SPONSORS OF THIS MIGHT
WERE THE INTERNATIONAL SOCIETY
FOR THE STUDY OF WOMEN'S SEXUAL
HEALTH. THE NATIONAL VULVODYNIA
ASSOCIATION. TIGHT LIPPED WHICH
YOU'LL HEAR FROM IN A FEW
MINUTES AND THE GYNECOLOGIC
CANCERS RESEARCH FOUNDATION AND
EACH SPONSOR CHOSE TWO PEOPLE TO
PARTICIPATE IN THE STEERING
COMMITTEE TO IDENTIFY TOPICS AND
POTENTIAL PARTICIPANTS WERE THEN
INVITED THE SUMMIT WAS VERY
RECENTLY HELD. LESS THAN TWO
MONTHS AGO IN FALLS CHURCH,
VIRGINIA, A SUBURB OF
WASHINGTON, D.C. AND THE FORMAT
WAS BASICALLY AFTER AN
INTRODUCTION AND A DISCUSSION ON
THE PROCESS, BASICALLY INVITED
SPEAKERS OR PRESENTERS WERE
GIVEN ABOUT TWENTY MINUTES TO
PITCH AN IDEA. AND MAYBE THEIR
IDEA, THEIR CURRENT RESEARCH OR
SOMETHING THEY THINK IS VERY
INTERESTING AND THEN IT'D BE
ABOUT 40 MINUTES FOR DISCUSSION
AMONG ALL THE PARTICIPANTS TO
HASH OUT BOTH THE FEASIBILITY OF
DOING RESEARCH IN THAT SPECIFIC
IDEA AS WELL AS IN IT REALLY
MADE ANY SENSE. THE LEADERSHIP
OF THIS MEETING WAS DR. PAUL Y.,
MYSELF, AND DR. JILL AS A
MEDICAL WRITER. THESE ARE THE
ATTENDEES AND TOPICS THAT WERE
PRESENTED IN 10-15 MINUTES I
CAN'T GO THROUGH ALL OF THEM. I
AM GOING TO TALK ABOUT THE TOP
THREE THAT WERE DISCUSSED. BUT
THESE ARE SOME OF THE TOPICS AND
AT THE END OF THIS TALKLY GIVE
YOU A LINK TO THIS PRESENTATION
SO YOU CAN DIVE INTO ALL OF THE
AREAS THAT WERE DISCUSSED OR
PRESENTED IN MORE DEPTH. SO LET
ME TAKE A CHANCE TO LOOK AT ALL
THE PRESENTERS AND WHAT THEY
PRESENTED ON. SO WE IDENTIFIED
FIFTEEN POTENTIAL THERAPEUTICS
AND THESE ARE IN ALPHABETICAL
ORDER. THE ONES IN RED WERE THE
ONES THAT SEEM TO GET THE MOST
ATTENTION OR INTEREST AMONG THE
PARTICIPANTS. AND THE MOST
DISCUSSION. AND THEN AFTER THE
SUMMIT, THE ATTENDEES
ANONYMOUSLY RANKED THE FIFTEEN
MOST PROMISING -- RANKED THE
THERAPEUTICS. THEY RANKED THEM
FROM 1-15 IF THEY WANTED TO RANK
ALL OF THEM AND THESE ARE THE
ONES THAT RECEIVED -- THESE ARE
THE SCORES. AND SO WE CAN SEE
THIS WAS THE ONE THAT RECEIVED
THE MOST INTEREST FOLLOWED JUST
BEHIND BY ANOTHER TWO. I AM
GOING TO DISCUSS THESE THREE
TOPICS RIGHT NOW. KETOTY FEN
BLOCKS THE H 1 RECEPTOR AND
INHIBITS LEUCO TRY YEN FORMATION
IT'S FDA APPROVED BUT ORAL
MEDICATIONS ARE ONLY SDIS PENCED
DID I COMPOUND LG PHARMACIES,
THERE ARE TOPICAL EYE DROPS
AVAILABLE.
AND RECENTLY IN 2022, ANOTHER
EYE DROP WAS APPROVED. USING
THIS COMPOUND. BUT IT'S MAINLY
UTILIZED FOR ASTHMA. ANIMAL
STUDIES THAT WERE PRESENTED BY
DR. JACOB BORN SIXTEEN, HE
DISCUSSED AN ANIMAL MODEL THAT
IS QUITE WELL-KNOWN IN
VULVODYNIA THAT HAS BEEN DONE IN
BOTH ROW -- IN RATS AND MICE.
AND BASICALLY PSI KNOW SAN IS
INJECTED INTO THE VULVARS OF
THESE ANIMALS. AND WHAT THAT
DOES IS IT CAUSES INCREASED
MECHANICAL SENSE AT THIS TIME.
THERE'S INCREASED MAST CELLS AND
KNOW SEW CEPTORS THAT DEVELOP IN
THE VESTY BILES OF THESE ANIMALS
WHICH IS WHAT YOU FIND IN THE
PATHOLOGY OF WOMEN UNDERGOING
HAVE YOUS TIBIA YOU ELECTMY. SO
WHAT HAPPENED WAS IN THE SAMPLES
THAT WERE PRESENTED KETO FEW TEN
WAS PROTECTED PRIOR TO THE
CHALLENGE. AND THIS CAUSED A
VERY SIGNIFICANT REDUCTION IN
ALL THE INFLAMMATORY CYTOKINES
AS WELL AS A REDUCTION IN THE
MAST CELLS THAT WOULD ACCUMULATE
WITHOUT THE KE TOTY FEN. IT
PREVENTED HYPER INTNOVATION AND
REDUCEDTOTIFEN. IT
PREVENTED HYPER INNOVATION AND
REDUCED PAIN IN THE RATS. AS
WELL AS PAIN RELATED ANXIETY.
ADDITIONALLY, DR. BORN SIXTEEN'S
GROUP ALSO LOOKED AT THE SPINAL
CORD AND KETOTIFEN ALSO
SUPPRESSED GENE EXPRESSION IN
THE SPINAL CORD SO IT LOOKS LIKE
IT IS POSSIBLE NOT ONLY TO
PREVENT LOCAL AFFECT OF
INFLAMMATION SUCH AS FOR CHRONIC
YEAST INFECTIONS BUT INDEED MAY
BE ABLE TO PREVENT CENTRAL
SENSITIZATION BY PREVENT IING
INCREASED SENSITIZATION AT THIS
SYSTEM. THE SECOND RANKED AND
IT WAS A TIE WAS RESKINNY FER
RAH TOXIN AND THIS WAS PRESENTED
BY DR. MICHAEL WHO IS AT NIH AND
DEPARTMENT OF CARE. AND
BASICALLY WHAT HAPPENS IS THIS
BINDS TO THE TRPV 1 ION CHANNEL
CAUSING CALCIUM OVERLOAD AND
CAUSES THE -- CAUSES THE SAY TO
TOXICITY OF THE RECEPTOR AND
THAT CAUSES A HIGHLY SELECTED
CHEMO AX OTMY, BASICALLY DENEVER
VAGUS. NOW THIS RESKINNY FER
RAH TOXIN IS AN ANALOG OF
CAPSAICIN BUT IT IS FIVE HUNDRED
TIMES MORE THAN CAPSAICIN AND
THAT HAS BEEN USED AND RECENTLY
MY GROUP PUBLISHED ON USING
CAPSAICIN FOR VES TIBIA YOU DIN
YA BUT THIS HAS THE POSSIBILITY
OF BEING INJECTED LOCALLY. AND
CAUSING A DENEVER VAGUS OF THE
NOCICEPTORS IN WOMEN WHO HAVE
THIS. HE'S CURRENTLY STUDYING
THIS DRUG IN HIS GROUP. AND
WITH AN INCREASE IN NOCICEPTORS
WHICH MAY BE AKIN TO THIS. AND
WE'RE CURRENTLY -- THERE'S A
PROPOSAL FOR AN IN-HOUSE NIH
PHASE ONE STUDY OF THIS BY HIS
COLLEAGUES AT NIH AS WELL AS MY
COLLEAGUES. TIE FOR SECOND WAS
MA RAISIN. AND WIZ WAS TALKED
ABOUT IN THE UNIVERSITY OF
ROCHESTER. THIS IS A MEDIATOR.
SPMS WORKED WITH THE
POLYUNSATURATED FATTY ACIDS
WHICH PROMOTE THE RESOLUTION OF
INFLAMMATION. SPMS ARE
EFFECTIVE IN REDUCING IL-1 AND
PGE2. STUDIES OF VESTIBULAE DIN
YA SHOW SIGNIFICANTLY. AS WELL
AS INFILTRATES. NOT JUST MAST
CELLS BUT OTHER INFLAMMATORY
CELLS. AND SO IT IS POSSIBLE IF
WE CAN SHOW THE DECREASE IN
INFLAMMATION, WE CAN HELP
PREVENT THE ONSET OF VULVA DIN
YA OR POTENTIALLY TREAT
VULVODYNIA AND DR. F. PRESENTED
BOTH RODENT STUDIES USING THE
SAME MODEL THAT DR. BORNSTEIN
TALKED ABOUT. AS WELL AS
FIBROBLASTS RESEARCH AND THE
FIBROBLASTS FOR WOMEN WITH VES
TIBIA LOW DIN YA AND IF YOU ADD
THIS FIRST AND THEN INDUCED
INFLAMMATION EITHER IO 1 BETA
THEN THE MARIE SIN REDUCED BOTH
OF THESE INFLAMMATORY MEDIATORS
AND ALSO REDUCED PAIN
SIGNIFICANTLY. MAYBE MORE
EXCITEDLY IS THAT MARI SIN ALSO
WAS ABLE TO DECREASE
INFLAMMATION ONCE THE
INFLAMMATION HAD ALREADY
STARTED. THIS WAS ALSO
AFTERWARDS ONCE THE INFLAMMATION
HAD ALREADY OCCURRED THEN
TREATING WITH MA RAISIN
DECREASED BOTH PAIN AS WELL AS
INFLAMMATION SO THIS MAY ALSO BE
THE POSSIBILITY OF NOT ONLY
PREVENTING VIL BUT TREATING
VULVODYNIA. BECAUSE I DON'T
WANT -- I WANT TO GIVE FIVE
MINUTES FOR LECTURES I'M NOT
GOING TO GO INTO ALL THE OTHER
POTENTIAL THERAPEUTICS THAT WE
DID DISCUSS. AGAIN, WHAT I
WOULD LIKE TO DO IS GIVE YOU
JUST A LINK TO THIS PRESENTATION
AND I AM HAPPY TO SOMEWHERE
CONTAIN QUESTIONS NOW OR IN THE
FUTURE. THE GOAL AGAIN IS TO
PRODUCE A WHITE PAPER OR SIMILAR
PAPER ABOUT THIS. WE'RE IN THE
PROCESS OF MAKING THIS DOCUMENT
SO WE DON'T HAVE IT AVAILABLE
YET BUT WE HOPE TO BE MAKING IT
AVAILABLE IN THE COMING HERE
YEAR. THANK YOU.
>> THANK YOU SO MUCH THAT WAS A
SHARK TANK FOR THERAPEUTICS:
THAT WAS AN INCREDIBLE IDEA. I
HEARD YOU NEXT STEP IS THE WHITE
PAPER BY IN TERMS OF MOVING THAT
FORWARD WHAT ARE SOFT OTHER NEXT
STEPS SHOULD I TELL YOU THAT NIH
WOULD BE INTERESTED IN
APPLICATIONS IN THIS FIELD?
>> ABSOLUTELY, CERTAINLY
PARTICIPANTS, DR. AUN WAS VERY
KIND ENOUGH TO JOIN THIS SUMMIT
AND TALKED ABOUT ALL OF THE
FUNDING MECHANISMS THAT NIH HAS
FOR FUNDING FOR VULVODYNIA
UNFORTUNATELY, MANY RESEARCHERS
HAVE NOT TAKEN NIH UP ON THE
OPPORTUNITY SO IT'S FRUSTRATING
AND I -- AS I SAID EARLIER,
IT'S -- WE CAN ONLY -- BE
ENVIOUS OF WHAT'S GONE ON IN
ENDOMETRIOSIS RESEARCH COMPARED
TO VULVODYNIA RESEARCH. BUT AS
I JUST MENTIONED, IT LOOKS LIKE
AT LEAST SOME OF THE COMPOUNDS
AT LEAST THE TOP THREE THEY'RE
MOVING TOWARDS PHASE ONE
CLINICAL TRIALS BOTH THE MARI
SIN AND MAYBE A LITTLE MORE WORK
ON THE OTHER TWO. SINCE THAT'S
AVAILABLE.
WE WOULD ENCOURAGE ANY
RESEARCHERS OUT THERE TO TAKE
UP THAT CHALLENGE. IT LOOKS
LIKE A PROMISING TREATMENT.
POSSIBILITY. AND IT RANKED THE
MOST AMONG ALL THE RESEARCHERS
PRESENT YET. WE NEED SOMEONE TO
TAKE UP THAT MANTLE.
>> WONDERFUL. THERE'S A
QUESTION FOR YOU IN THE CHAT
BASED ON THESE NEW THERAPEUTICS
DO WE HAVE ANY INFORMATION ON
WHETHER -- WHAT THEIR PAIN
PROFILE IS IN TERMS OF ARE MAY
MORE OR LESS PAINFUL THAN
CAPSAICIN?
>> WELL THE -- SPECIFICALLY RAH
SIN FER ROW TOXIN WOULD BE
ADMINISTERED AFTER LOCAL
ANALGESIA SO AN INJECTION OF A
LOCAL ANESTHETIC. AND THIS LONG
ACTING. THE PAIN FROM RAH SIN
FER RAH TOXIN WOULD BE QUITE
INTENSE WITHOUT THIS INJECTION
OF THE LOCAL ANALGESIA. BUT
WITH THE INJECTION OF THE LOCAL
IT WILL LONG LASTER THAN THE
PAIN FROM THE RAH SIN KNOW FER
RAH TOXIN OR AT LEAST THAT'S
WHAT WE BELIEVE.
>> INTERESTING, THANK YOU. AND
THEN THERE'S A QUESTION ABOUT --
DO WE KNOW ANYTHING ABOUT HOW
THESE THERAPEUTICS MIGHT MEASURE
AGAINST STANDARD OF CARE NOW
WHICH MIGHT INCLUDE TOPICAL
ESTROGEN OR OTHER HORMONAL
CREAMS?
>> I THINK THAT THE PROBLEM WE
HAVE WITH THE VULVODYNIA IS T
THAT, YOU KNOW, THIS IS A BIG
GROUP OF DIFFERENT DISORDERS
THAT WE ALL LUMP INTO VULVODYNIA
SO WHEREAS, TOPICAL HORMONES
CERTAINLY MAY BE VERY BENEFICIAL
AND HORMONALLY ASSOCIATED
VULVODYNIA. IT'S UNLIKELY TO BE
VERY, VERY USEFUL IN NEEDING ONE
THAT'S INFLAMMATORY OR NEURO
PROLIFERATIVE SO I THINK THAT
THE GOAL OF THE MOST RECENT VIL
NOMENCLATURE IS TO TRY TO BREAK
OUT SUBCATEGORIES OF VULVODYNIA.
AS WELL AS ASSOCIATED FACTORS OF
THE UNDERLYING HISTOPATHOLOGY
AGAINST SITINFLAMMATION OR
PROLIFERATION OR HORMONAL CAUSES
OR SECONDARY TO OVERACTIVE
PELVIC FLOOR MUSCLE DYSFUNCTION
AND THEN IN SO DOING, I THINK WE
CAN HONE OUR RESEARCH TO -- AND
THEREFORE I THINK WE'RE GOING TO
HAVE THE -- MUCH MORE SUCCESSFUL
IN FINDING A THERAPEUTICS.
BECAUSE THE TWO LARGE SCALE
FUNDED STUDIES FROM -- THAT WERE
FUNDED BY NIH BOTH IN GABAPENTIN
REALLY FAILED TO SHOW ANY
BENEFIT BUT THAT MAY HAVE BEEN
BECAUSE WE TOOK JUST ALL NUMBERS
OF PEOPLE WHO HAD VULVODYNIA AND
WE DIDN'T MAKE THE EFFORT TO THE
SUBCATEGORY OF THESE WYOMING I
THINK WE'RE MAYBE 20 YEARS
BEHIND SOME OF THE OTHER.
PELVIC PAIN FIELDS OR
GYNECOLOGIC PAIN FIELDS I THINK
WE'RE DOING OUR BEST TO CATCH UP
TO HELP THE WOMEN WHO SUFFER
FROM THIS PAIN.
>> THANK YOU IT SOUNDS LIKE LOTS
OF POSSIBILITIES TO CATCH UP.
IT SEEMS THERE ARE LOTS OF
PRESENTATION IN THE LINK. WE
WILL ASK YOU TO PUT THAT IN THE
Q&A OR THE LINK AND WE WILL SEND
IT OUT I AM SURE DR. AUN AT THE
END OF THIS MEETING WILL SEND
OUT LOTS OF INFORMATION TO
THOSE. THANK YOU SO MUCH FOR
PRESENTING THOSE REALLY EXCITING
OPTIONS.
>> AGAIN, THANKS FOR HAVING ME
I'M HAPPY TO ANSWER MORE
QUESTIONS BY E-MAIL.
>> THANK YOU. AND THEN I WILL
SAY WE'LL ASK THE DOCTOR TO
STICK AROUND AND ANSWER ANY IF
HE IS STILL AVAILABLE SO WE NOW
TURN VERY HAPPILY TO TOP PATIENT
ADVOCATES AND PATIENT
PERSPECTIVES. FOR REALLY
UNDERSTANDING A DIFFERENT POINT
OF VIEW OF THINGS AND WHAT'S
GOING ON IN THE ADVOCACY WORLD.
SO WE'RE GOING TO START WITH
REPRESENTATIVES FROM TIGHT
LIPPED WHICH IS A GRASSROOT
MOVEMENT CREATED BY PEOPLE WITH
PELVIC PAIN AND THE FIRST TO
SPEAK TO THAT WILL BE NOAH. I
WILL TURN IT OVER TO YOU.
>> GREAT, THANK YOU SO MUCH.
LET ME JUST SHARE MY SCREEN.
OKAY SO THANK YOU SO MUCH FOR
INVITING US AND FOR PUTTING
TOGETHER THIS CONFERENCE TODAY I
AM HERE REPRESENTING MANY
PATIENTS WITH CHRONIC AS A RULE
VOE VAGINAL AND PELVIC PAIN
CONDITIONS AND WE KNOW HOW
IMPORTANT IT IS FOR THERE TO BE
RESEARCH INTO ANY TREATMENTS,
INTO THE CAUSES AND BETTER
UNDERSTANDING OF WHAT CAUSES
THESE CONDITIONS AND HOW CONNECT
MORE EFFECTIVELY TREAT THEM SO
MY NAME IS NOAH, I'M THE
EXECUTIVE DIRECTOR OF TIGHT
LIPPED AND I WILL TALK ABOUT
BARRIER TO CARE AND ABOUT
PATIENT STORIES. SO I WANT TO
JUST SHARE VERY BRIEFLY A LITTLE
BIT ABOUT OUR ORGANIZATION. AS
CANDACE MENTIONED WE ARE A
GRASSROOTS ADVOCACY ORGANIZATION
AND WE ARE FOCUSED TO HELP
PATIENTS ACCESS THE CARE THAT
THEY NEED. WE HEARD FROM SO
MANY PEOPLE AND ALSO THIS IS
FOLLOWED WITH ALL THE STUDIES
THAT HAVE BEEN DONE ON THIS THAT
SO MANY PATIENTS WITH AS A RULE
VOE VAGINAL PAIN REALLY STRUGGLE
TO GET DIAGNOSED, GO YEARS
BEFORE GETTING DIAGNOSED AND
REALLY STRUGGLE TO FIND
EFFECTIVE TREATMENT I COME TO
THIS FROM MY OWN PERSPECTIVE AND
I KNOW FROM MY OWN PERSONAL
EXPERIENCE HOW DIFFICULT IT IS
TO GET DIAGNOSIS AND THE TREATED
FOR THESE CONDITIONS WHEN I
FIRST WENT TO MY GYNECOLOGIST
AND WAS IN SO MUCH PAIN I COULD
NOT TOLERATE TAMPONS, PELVIC
EXAMS MY GYNECOLOGIST SAID THAT
WAS JUST ANXIETY AND DID NOT
THINK THAT WAS A REAL MEDICAL
CONDITION AND PUT ME UNDER
GENERAL ANESTHESIA IN ORDER TO
TOLERATE MY PAP SMEAR AND SENT
ME HOME TO DIFFICULT IT ON MY
OWN SO I NOW HOW DIFFICULT IT IS
TO GET TREATED. WE STARTED AS A
PODCAST AND ALMOST IMMEDIATELY
AFTER LAUNCHING THE PODCAST WE
WERE FLOODED WITH STORIES FROM
PEOPLE ALL OVER THE WORLD
ESSENTIALLY TELLING US THE SAME
STORY OF HOW DIFFICULT IT WAS TO
DEAL WITH THE STIGMA AND HOW
DIFFICULT IT WAS FOR THEM TO BE
ABLE TO GET ACCURATE AND
ADEQUATE CARE. SO WE HAVE
EXPANDED BEYOND BEING A
STORYTELLING PROJECT, WE ARE AN
ADVOCACY ORGANIZATION AND WORK
IN COLLABORATION BETWEEN
PATIENTS AND MEDICAL PROVIDERS
WORKING TOWARDS A FUTURE WHERE
PATIENTS HAVE THE CARE THEY NEED
AND WHERE THERE IS NO STIGMA
ASSOCIATED WITH THESE
CONDITIONS. WE HAVE ACTIVE
CHAPTERS ACROSS THE COUNTRY. WE
ARE A NATIONAL ORGANIZATION. WE
HAVE CHAPTERS IN LOS ANGELES,
NEW YORK, CONNECTICUT,
PHILADELPHIA, ALL OF OUR
VOLUNTEERS HAVE A WHOLE RANGE OF
CONDITIONS. I WILL SHOW YOU A
LITTLE BIT OF BACKGROUND ON WHAT
CONDITIONS. SO WE'RE REALLY AN
UMBRELLA ORGANIZATION THAT
COVERS A NUMBER OF DIFFERENT
CONDITIONS THAT COVERS PELVIC
FLOOR PAIN. WE KNOW THERE'S A
VAST AMOUNT OF CONDITIONS,
VULVODYNIA, AND ALSO LICHEN SKER
LOW SUS AND A WE HAVE A
COMMUNITY NETWORK OF PEOPLE WHO
HAVE A WHOLE BUNCH OF
OVERLAPPING CONDITIONS AND WHO
ALSO COME TO US WITH ANY NUMBER
OF THESE SYMPTOMS AND
EXPERIENCES. AS WE KNOW THESE
CONDITIONS ARE SUPER, SUPER
COMMON EVEN THOUGH THEY'RE
REALLY STIGMATIZED, UP TO 28% OF
WOMEN IN THE UNITED STATES AND
WE KNOW IT'S NOT JUST WOMEN BUT
ALSO FOLKS WHO ARE NONBINARY,
TRANSGENDER, ANYONE CAN
EXPERIENCE CHRONIC AS A RULE VOE
VAGINAL AND CHRONIC PAIN AND
IT'S SUPER COMMON AND CHRONIC
CONDITION. WE WORK WITH
ABSOLUTELY GREAT MEDICAL
PROVIDERS. THESE ARE SOME OF
THE MEDICAL PROVIDERS THAT WE
WORK WITH. THIS IS THE ADVISORY
BOARD. OBGYN, VAGINAL PAIN
SPECIALIST, PHYSICAL THERAPISTS
AND SO MANY OTHERS WHO HAVE
DEDICATED THEIR LIVES AND
CAREERS TO TREATING PEOPLE WITH
THESE CONDITIONS. SO I'M GOING
TO PASS IT OVER TO KEENA WHO IS
HERE. KEENA IS THE CHAIR OF
OUR -- CO-CHAIR OF OUR LOS
ANGELES CHAPTER AND SHE WILL
SHARE ABOUT HER OWN PERSONAL
STORY AND EXPERIENCE BECAUSE SO
MUCH OF OUR WORK IS MOTIVATED BY
THE STORIES AND EXPERIENCES THAT
WE'VE HAD OURSELVES AND SO WE
WANT TO SHED A LITTLE BIT OF
LIGHT ON WHAT THAT HAS BEEN
LIKE.
>> THANK YOU, KNOW WASHGS THANK
YOU FOR PASSING IT OVER TO ME.
I WANTED TO START OFF BY
THANKING THE GHDB AND THE NICHD
AND THE NIH FOR HOST THING
EVENT. MY NAME IS KEENA, I'M
HONORED TO BE HERE AND HAVE A
FEW MINUTES TO SHARE MY STORY
WHILE MY EXPERIENCES DON'T
ENCOMPASS THAT OF EVERY PATIENT
I HOPE I CAN IMPART A SENSE OF
WHAT IT IS LIKE TO LIVE WITH
THESE PAIN CONDITIONS WHEN I WAS
19, I WANTED TO START TAKING
BIRTH CONTROL SO I VISITED MY
GYNECOLOGIST. AND HE CATALOGED
THE MANY WAYS BIRTH CONTROL
WOULD BENEFIT ME HE ALSO WORNED
ME OF BLOOD CLOTS BUT THAT WAS
ONLY THE SIDE EFFECT I WAS GIVEN
MANY IN MY OIMENT. I WAS MAKING
A DECISION TO TAKE A MEDICATION
THAT WOULD DRASTICALLY ALTER MY
LIFE. FAST FORWARD A FEW YEARS
ALL THROUGHOUT MY 20S I
EXPERIENCED UTISES I WAS TOLD I
WAS PRONE TO THEM, PRICED
ANTIBIOTICS AND NONE OF MY
DOCTORS INVESTIGATED FURTHER
THEN I WAS 28 I HAD A UTI THAT
WOULDN'T GO AWAY I TOOK
ANTIBIOTICS FOR MONTHS AND
DEVELOPED AN ALLERGY TO
AMOXACILLIN I WAS IN SUCH
EXCRUCIATING PAIN THAT GOING TO
WORK WAS TORTURE I COULDN'T USE
TAMPONS, WEAR PANTS OR HAVE SEX
NOT KNOWING WHERE ELSE TO GO I
EVENTUALLY FIND A UROLOGIST AND
SEXUAL MEDICINE SPECIALIST WHO
DIAGNOSED ME WITH HORMONALLY
MEDIATED VIS TIBIOFIBULAR DIN
YA. HE TOLD ME THESE HAD WORKED
IN MY VESTIBULE. THIS HORMONE
DEFICIENCY CAUSED MY TISSUES TO
BECOME THIN AND DAMAGED LEADING
TO ALL MY PAIN SYMPTOMS. I WAS
SHOCKED. WHY HADN'T I BEEN
WARNED OF THIS AS A POTENTIAL
SIDE EFFECT? WHEN I PUSHED MY
ANGER DOWN AND TOLD MYSELF TO BE
DWRATFUL FOR A DIAGNOSIS HOWEVER
THINGS DIDN'T GET EASIER FROM
THERE.
MY UREA ROLL GIST PRESCRIBED TWO
MEDICATIONS ESPECIALLY
COMPOUNDED TOPICAL ESTROGEN AND
TESTOSTERONE CREAM AND A
TESTOSTERONE JELL AND WARNED ME
THESE MEDICATIONS WERE
TECHNICALLY OFF LABEL BECAUSE
THEY HAD NOT BEEN STUDIED ENOUGH
IN FEMALE BODIES FOR THE FDA TO
APPROVE THIS MEDICATION FOR USE
IN PATIENTS WITH VULVAS THEY
WERE NOT COVERED BY INSURANCE
AND COST ME IN TOTAL ALMOST 250
DOLLARS. AGAIN, I PUSHED MY
ANGER DOWN AND TOLD MYSELF TO BE
GRATEFUL I COULD AFFORD MY
MEDICATIONS. I THOUGHT THIS
WOULD BE THE END OF IT BUT
THINGS DID NOT GET EASIER. I
DIDN'T TO MY MEDICATIONS AS
QUICK AS MY DOCTORS EXPECTED.
HOW LONG WOULD HEALING TAKE WITH
MY COMORBIDITICOMORBIDITIES. M
HAD NO ANSWERS. HOWEVER WE KNOW
AS MANY AS 50 MILLION PEOPLE IN
THE UNITED STATES HAVE AN
AUTOIMMUNE DISEASE AND PEOPLE
WITH VIL HAVE AN ARES MORE
LIKELY TO EXPERIENCE THEM.
AND WE KNOW THEY'LL EXPERIENCE
PAIN IN THEIR LIFETIME.
WHILE I FELT ISOLATED AND ALONE
IN DEALING WITH MY CONDITIONS I
KNEW THERE WERE LIKELY MANY MORE
PEOPLE OUT THERE WITH THE SAME
UNANSWERED QUESTIONS SO I
PURSUED TWO PROCEDURES. THE
FIRST A LASER TREATMENT TO HELP
WITH MY VAGINAL TISSUES, THE
SECOND, BOTOX INJECTIONS TO MY
PELVIC FLOOR MUSCLES WHICH WERE
TIGHT FROM A YEAR OF CONSTANT
PAIN AND CLENCHING THESE WERE
CONSIDERED COSMETIC PROCEDURES
AND WERE ONCE AGAIN OFF LABEL
USES BECAUSE THEY'D NOT BEEN
STUDIED ENOUGH IN FEMALE BODIES
THE TOTAL COST OF THESE
PROCEDURES WAS $7,000 THE
DECISION TO RECEIVE THESE
TREATMENTS WAS A HEAVYWEIGHT ON
MY SHOULDERS. I WAS WRACKED
WITH FEAR AND GUILT WHAT IF THEY
DIDN'T WORK? WHAT AN INCREDIBLE
FINANCIAL BIRD BURDEN I WAS TO
MY HUSBAND AND FAMILY.
MY INTERNET SEARCHES WERE
LACKING IN HARD EVIDENCE.
ULTIMATELY, I CHOSE TO TRUST MY
DOCTORS AND LUCKILY BOTH
TREATMENTS WERE INCREDIBLY
EFFECTIVE IN TREATING MY VULVA
VAGINAL AND PELVIC FLOOR PAIN.
IN MY ADVOCACY EFFORT WITH TIGHT
LIPPED I WORKED WITH ADMIRABLE
DOCTORS WHO ARE DOING THEIR BEST
THROUGH THEM I LEARN THAT HAD WE
KNOW THERE ARE GENETIC MARKERS
FOR PEOPLE LIKE ME.
PEOPLE WHO COULD DEVELOP THIS
FROM ORAL CONTRACEPTIVES WITH
PROPER RESEARCH AND FUND THING
COULD BE DEVELOPED INTO A TEST
AND BE GIVEN PRIOR TO BEING
PRESCRIBED BIRTH CONTROL. IT
PAINS ME THAT THIS TEST WILL
PROBABLY NEVER SEE THE LIGHT OF
DAY BECAUSE OF LACK OF FUNDING.
IT PAINS ME THAT I COULD HAVE
NOT HAD PAIN BECAUSE OF THE LACK
OF A TEST. IT FRUSTRATES ME
THAT THERE'S A MISCONCEPTION
THAT MY DIAGNOSIS IS RARE WHEN
IN REALITY WE SIMPLY JUST DON'T
KNOW HOW MANY PEOPLE THIS
CONDITION AFFECTS. IT HAS BEEN
FIVE YEARS SINCE I FIRST
EXPERIENCED VULVAR VAGINAL PAIN
AND I STILL AM NOT PAIN-FREE.
I COULD TELL YOU MY HEALTH
JOURNEY AND ALL THE DEAD ENDS WE
HAVE REACHED BECAUSE THERE IS NO
DATA. I COULD KEEP TELLING YOU
ABOUT ALL THE PROCEDURES I PAID
FOR OUT OF POCKET BECAUSE THERE
NO DATA TO FORCE THE HAND OF
INSURANCE TO COVER THEM. I
COULD WALK YOU THROUGH THE
COUNTLESS DISCUSSION I'VE HAD
WITH MY HUSBAND. WHAT TREATMENT
SHOULD WE SPEND THOUSANDS OF
DOLLARS ON. I COULD TALK ABOUT
WHAT'S WORSE, THE FEAR OF MAKING
THE WRONG GAMBLE OR THE
CONTINUED DEEPENING
CLAUSTROPHOBIA OR TAKING NO
ACTION AND KNOWING THAT ONLY
ASSURES MORE PAIN AND THE
CRUMBLING OF MY QUALITY OF LIFE
BY THAT WOULD TAKE HOURS AND WE
ONLY HAVE FIFTEEN MINUTES SO I
WILL LEAVE YOU WITH THIS IT IS
ABSOLUTELY TERRIFYING TO BE A
PATIENT WITH ACCESS AND
PRIVILEGE WORKING WITH DOCTORS
WHO ARE THE BEST IN THEIR FIELD
AND BEING TOLD WE JUST DON'T
KNOW ENOUGH AT EVERY TURN.
THANK YOU FOR YOUR TIME. AND
BACK OVER TO NOAH.
>> THANK YOU SO MUCH FOR SHARING
YOUR STORY. UNFORTUNATELY,
KEENA'S STORY IS AN EXTREMELY
COMMON STORY, EVERYDAY WE GET
MESSAGING FROM PATIENTS ACROSS
THE COUNTRY SHARING ABOUT THEIR
EXPERIENCES AND THE AMOUNT OF OF
MONEY TIME, THEY'VE HAD TO SPENT
WITH TRIAL AND ERROR OF
TREATMENTS I'M IN AND OUT GOING
TO GO INTO ALL THE DIFFERENT
BARRIER TO CARE BUT I WANT TO
HIGHLIGHT A COUPLE OF THINGS
FROM KEENA'S EXPERIENCE ONE IS
STIGMA. STIGMA IS A HUGE
BARRIER TO CARE THE FACT THAT WE
DON'T TALK ABOUT THESE
CONDITIONS, THAT THEY DON'T
RECEIVE THE RECOGNITION AND THE
FUNDING THAT THEY DESERVE AND
THAT MANY PATIENTS ARE OFTEN
DISMISSED AND THEIR INITIAL
SYMPTOMS ARE U SEEN AS THINGS
THAT ARE PSYCHOLOGICAL,
PSYCHOSOMATIC AND NOT WORTHY OR
IN NEED OF MEDICAL CARE THE
SECOND ONE I WANT TO HIGHLIGHT
IS LACK OF EDUCATION AND MEDICAL
KNOWLEDGE. MOST PATIENTS
STRUGGLE TO FIND A PROVIDER THAT
CAN DIAGNOSE THEM, TREAT THEM
AND MANY PATIENTS HAVE TO PAY
HUGE AMOUNTS OF MONEY TO FIND
SOMEONE OR FLY TO ANOTHER CITY
OR STATE TO FIND SOMEONE WITH A
BACKGROUND ON THIS. THE THIRD
ISSUE WHY WE'RE ALL HERE TODAY
IS LACK OF RESEARCH. THERE ARE
NOT ENOUGH TREATMENTS THAT ARE
WELL RESEARCHED FOR THESE
CONDITIONS AND MANY TREATMENTS
ARE TRIAL AND ERROR. AND AREN'T
ACTUALLY PROVEN TO BE EFFECTIVE
OR WE DON'T KNOW YET IF THEY ARE
EFFECTIVE AND INSURANCE AND
ACCESS TO CARE. MANY PATIENTS,
WHEN THEY DO FIND SOMETHING THAT
IT ACTUALLY WORKS FOR THEIR PAIN
IS NOT COVERED BY INSURANCE. IN
PART BECAUSE THERE ISN'T DATA
AND EVIDENCE BUT ALSO IN PART
BECAUSE INSURANCE DOESN'T COVER
THIS AS AN ESSENTIAL HEALTH
BENEFIT AND ALL OF THESE THINGS
PLAY INTO EACH OTHER. I WANT TO
LEAVE YOU WITH ONE THING WHICH
IS THAT AS A PATIENT-LED
ORGANIZATION, WE WROTE A
PETITION, A LETTER, WHEN THE WHO
IS WHITE HOUSE ANNOUNCED THE
INITIATIVE.
WITHIN A COUPLE DAYS WE HAD 835
PATIENTS WHO ARE WILLING TO SIGN
THEIR NAMES AND IDENTIFY
THEMSELVES WITH THEIR CONDITION
AND SAY I AM WILLING TO PUSH
PASS THE STIGMA AND SAY I HAVE
THE CONDITION IN ORDER TO PUT MY
VOICE OUT THERE AND TO SAY HOW
IMPORTANT IT IS FOR THERE TO BE
MORE INVESTMENT IN STUDYING NEW
TREATMENTS AND RESEARCH. THE
STATEMENTS THAT PEOPLE WROTE
WHEN THEY KIND OF TESTIFIED FOR
WHY THEY WERE SIGNING ONTO THIS
LETTER WERE INCREDIBLY
HEARTBREAKING AND MOVING.
PEOPLE TELLING US THEY'VE BEEN
STRUGGLING WITH THESE CONDITIONS
FOR YEARS AND WHAT IMPACT THAT
HAD HAD ON THEIR LIVES. WE HAVE
ACTUALLY A 30 PAGE DOCUMENT OF
TESTIMONIES WHEN WE ASKED PEOPLE
WHY ARE YOU SIGNING ON. THEY
SUBMITTED STORY AFTER STORY OF
TESTIMONY AFTER TESTIMONY OF HOW
IMPORTANT IT IS FOR THEM THAT
THERE'S MORE RESEARCH AND AN
INVESTMENT IN STUDYING THESE
CONDITIONS. AND THE NUMBER OF
TESTIMONIES WE RECEIVED
LITERALLY FILLED 30 PAGES AND I
AM HAPPY TO SHARE THOSE
TESTIMONIES WITH ANYONE WHO IS
INTERESTED. SO I NOW WE ONLY
HAVE A MINUTE LEFT IF PEOPLE
HAVE QUESTIONS AND WE ARE SO
APPRECIATIVE TO BE HERE TODAY
AND TO SEE THAT TOGETHER
PATIENTS AND RESEARCHERS ARE
REALLY TRYING TO INVEST IN
RESEARCHING THESE CONDITIONS.
I'M HAPPY TO ANSWER ANY
QUESTIONS IN THE Q&A AND ALSO
CONTINUE AFTER THE SESSION IF
PEOPLE HAVE QUESTIONS THAT THEY
WANT TO SEND OVER E-MAIL.
>> THANK YOU, NOA AND KEENA, I
HOPE YOU SEE THE REACTIONS IN
YOUR AUDIENCE WHO ARE COMPLETELY
MOVED BY YOUR STORIES. I THINK
NOTHING BETTER DEMONSTRATES WHY
WE SUPPORT THIS RESEARCH AND WHY
EVEN MORE IS NECESSARY THAN
HEARING SOME OF THE SUFFERING
AND I THINK IT'S HELPFUL FOR
ANYBODY IN OUR AUDIENCE TO HEAR
SOME OF THE SPECIFICS OF WHAT,
YOU KNOW, SOME PEOPLE FEEL
BECAUSE THEY MIGHT FEEL ALONE IN
THEIR EXPERIENCES. SO THAT'S
INCREDIBLE I JUST WANT TO SAY,
IF SOMEONE HAS QUESTIONS ON
CLINICIANS OR QUESTIONS FOR THE
COMMUNITY OR THINGS LIKE THAT,
IS THAT SOMETHING THEY COULD
ACCESS THROUGH YOUR GROUP?
>> YES, WE HAVE A SPREADSHEET
THAT -- THERE'S SOME AMAZING
RESOURCES OUT THERE AND WE HAVE
A SPREADSHEET THAT COMPILES ALL
THE DATABASES FOR FINDING A
CLINICIAN IN YOUR AREA AND OTHER
REPUTABLE MEDICAL RESOURCES AND
I WILL SHARE THE LINK TO THAT
RIGHT NOW IN THE CHAT.
>> PERFECT, THANK YOU SO MUCH.
SO WE DO NEED TO MOVE ON BUT I
AM SURE THERE'LL BE QUESTIONS
THAT POP UP FOR YOU BOTH AND IF
THE AUDIENCE WANTS TO PUT THOSE
IN THE Q&A I WILL ASK NOA AND
KEENA TO STAY ON THE Q&A AND
ANSWER THOF SMOEZ SOME OF THOSE
QUESTIONS IF THEY ARISE. LAST
IN THE SESSION WE WILL TURN IT
OVER TO DR. SUSAN WHO IS THE
DIRECTOR OF FEMALE SEXUAL
MEDICINE AND IS HERE
REPRESENTING THE NATIONAL
VULVODYNIA ASSOCIATION WHICH IS
ANOTHER ADVOCACY COMMUNITY WHO
IS WORKING TO IMPROVE RESEARCH
AND COMMUNITY IN THE FIELD OF
VULVODYNIA. SO I WILL TURN IT
OTHER TO YOU DR. SPADT.
THE HEALTH AND QUALITY OF LIFE OF
WOMEN SIFRING FROM CHRONIC
VULVAR PAIN.
THE MISSION FROM THE NATIONAL
VULVODYNIA ASSOCIATION WAS TO
PROVIDE UP-TO-DATE TREATMENT AND
RESEARCH INFORMATION SO PATIENTS
COULD MAKE DECISIONS ABOUT THEIR
CARE TO MAINTAIN A NATIONWIDE
REFERRAL OF OBGYNS TO HELP TREAT
VULVODYNIA AND FUND RESEARCH ON
THE PATH TROE FIZZ AND TREATMENT
OF VULVODYNIA. NEXT SLIDE,
PLEASE.
THE ISS VD CLASSIFICATION OF
VULVODYNIA IS THAT VULVODYNIA IS
VULVAR PAIN OF AT LEAST THREE
MONTHS DURATION WITHOUT A CLEAR
IDENTIFIABLE CAUSE WHICH MAY
HAVE A POTENTIAL ASSOCIATED
FACTORS AND IT MIGHT BE
GENERALIZED WITH MULTIPLE AREAS
OF THE VULVA AFFECTED OR
LOCALIZED WITH ONE AREA LIKE THE
CLITORIS, LIKE CLIT OWE DIN YA
OR MIXED LIKE LOCALIZED OR
GENERALIZED VULVODYNIA IT MINUTE
MAY BE PROVOKED WITH INSERTIONAL
OR CONTACT PAIN AND SPONTANEOUS
OR MIXED WITH BOTH PROVOKED AND
SPONTANEOUS IT MIGHT ONLY AFFECT
THE VESTY BUELL WHICH IS KNOWN
VES TIBIA BÜLOW DIN YA WHICH WAS
PREVIOUSLY KNOWN AS VULVAR VES
TIBIA YOU LIGHTS SYNDROME.
THIS CAN OCCUR FROM THE VERY
FIRST TIME THE VULVAR WAS
CONTACTED OR SECONDARY AFTER A
PERIOD OF PAIN-FREE CONTACT.
AND IT CAN BE INTERMITTENT OR
CONSTANT, IMMEDIATE OR DELAYED.
NEXT SLIDE, PLEASE. AS HAS BEEN
MENTIONED THE LIFETIME ESTIMATES
OF -- IN TERMS OF PREVALENCE ARE
8-28% THE GENERAL POPULATION AND
THE MOST COMMON SUBTYPE IS
VESTIBULODYNIA WHERE THERE IS
PAIN ON THE CONTACT. DESPITE
THIS HIGH PREVALENCE ONLY 60%
LOOK FOR TREATMENT AND ONLY 50%
HAVE A DIAGNOSIS. AND IT IS
AFFECTING A HIGHER RATE OF
HISPANIC WOMEN. SO LIVING WITH
VULVODYNIA LIMITS ACTIVITIES OF
DAILY LIVING AS HAS ALSO BEEN
SPOKEN OF. HOW ABOUT SITTING
FOR EXTENDED PERIODS? THAT'S
AMAZING. THAT REALLY IMPACTS
DAILY LIFE. ENGAGING IN THINGS
LIKE PHYSICAL EXERCISE, SEXUAL
INTERCOURSE, SOME WOMEN RESIGN
FROM THEIR ABILITY TO WORK THEIR
JOBS BECAUSE THEY CANNOT SIT AND
THEY CANNOT GO THROUGH A DAY AT
WORK WITHOUT SO MUCH PAIN AND
THEY APPLY FOR DISABILITY. AND
THAT IS VERY DIFFICULT FILLING
OUT THOSE APPLICATIONS FOR
DISABILITY AND MANY TIMES ARE
DENIED THAT DISABILITY. SEVERAL
STUDIES THAT SUMMARIZE THE
NEGATIVE BIO PSYCHOSOCIAL
EFFECTS OF VULVODYNIA. NEXT
SLIDE, PLEASE. THE NATIONAL VIL
VULVODYNIA ASSOCIATION SHOWS
ONLINE TUTORIALS THAT INCLUDE
ESSENTIAL INFORMATION SO
PATIENTS CAN GIVE ADVICE ON
SEXUAL AND RELATIONSHIP ISSUES
AND MAXIMIZE HEALTH CARE VISITS
TO HAVE A LIST OF QUESTIONS
READY FOR THEIR PROVIDERS. THE
NATIONAL VULVODYNIA ASSOCIATION
HAS PUBLISHED FOUR ONLINE
EDUCATIONAL BOOKLETS. WE
MAINTAIN SEVERAL REFERRAL LISTS
ORGANIZED BY STATE AND COUNTRY.
HELPING THAT PATIENTS FIND
HEALTH CARE PROVIDERS WITH
EXPERTISE IN THE DIAGNOSIS AND
TREATMENT OF VULVAR PAIN AND WE
OFFER SUPPORT TO CONTACT AND
ANSWER PATIENTS' QUESTIONS
PROVIDING LOCAL RESOURCES AND
EMOTIONAL SUPPORT TO PATIENTS AS
WELL. NEXT SLIDE, PLEASE. WE
ALSO OFFER DIAGNOSTIC AND
TREATMENT ONLINE TUTORIAL
QUARTERLY RESEARCH ABSTRACTS ON
CHRONIC VULVAR PAIN THAT ALSO
INCLUDES ABSTRACTS ON PIE DENIAL
NEURALGIA AND PERSISTENT GENITAL
AROUSE SAL DISORDER. AND WE HA
RESEARCH GRANTS UP TO 100,000
DOLLARS. NEXT SLIDE, PLEASE.
TO DATE THE NVA RESEARCH GRANTS
THAT HAVE BEEN AWARDED SINCE
2004 HAVE TOTALLED ALMOST 2
MILLION DOLLARS IN PILOT
RESEARCH GRANTS THAT RANGE FROM
40,000 DOLLARS TO 75,000 DOLLARS
AT A TIME. WE HAVE GIVEN
RESEARCH TO PILOT DATA AND LARGE
GRANTS AS WELL. FROM THE NIH
AND CANADIAN INSTITUTE OF HEALTH
SOME GRANT RECIPIENTS INCLUDE
VERY, VERY IMPORTANT RESEARCHERS
LIKE MELISSA FARMER THAT USES
THE MOUSE MODEL OF VES TIBIA
BÜLOW DIN YA, AND MEGAN FALL
SETA THAT WE HEARD FROM IN TERMS
OF LOOKING AT THE FIE BBROBLAST
AND ALSO LOOKING FROM VALERIE
WHO LOOKS AT THE NEUROPHYSIO
LOGICAL AND PSYCHOLOGICAL
CORRELATES OF VULVODYNIA AND
LINDA WHO IS LOOKING AT THE LOW
LEVEL LASER THERAPY FOR PAIN.
NEXT SLIDE, PLEASE. WE ALSO
OFFER THE MARY NOVEMBER CAREER
DEVELOPMENT AWARD TO ENCOURAGE
JUNIOR FACULTY TO PURSUE A
CAREER IN VULVODYNIA RESEARCH.
AND WE GIVE IT TO SIX OF
FOURTEEN RECIPIENTS HAVE MADE
SIGNIFICANT CONTRIBUTIONS IN
VIL AND THERE ARE 11 PAIN
CLINICS THAT ARE STILL OPERATING
THAT THE NVA STARTED, GAVE THEM
THE SEED MONEY TO HELP OPERATE
IN AND THEY'RE SO OPEN.
INCLUDING ONE IN LUMBAR LYNN
POLAND.
NEXT SLIDE, PLEASE.
THE NEWSLETTERS ARE REALLY
SOMETHING THAT ARE JUST
WONDERFUL THE NEWSLETTERS
PUBLISHED RESEARCH ABSTRACTS
THAT ARE BOTH HELPFUL FOR
CLINICIANS AND PEOPLE WHO ARE
SUFFERING WITH VULVODYNIA ALIKE
THEY ALSO OFFER ADVICE FOR
SEXUAL INTIMACY AND INSPIRING
PERSONAL STORIES FOR WOMEN WITH
VULVODYNIA. PATIENTS SAY I'VE
JUST LEARNED SO MUCH FROM THE
NEWSLETTER AND MY DOCTOR
ACTUALLY READS THEM ALL THE TIME
WHICH IS TRUE. AND PATIENTS
ALSO SAY WHEN THEY ARE IN SO
MUCH EMOTIONAL PAIN AND
DEPRESSION THE ARTICLES IN THE
NEWSLETTER LIFT THEM UP. NEXT
SLIDE, PLEASE. THE NATIONAL
VULVODYNIA REGISTRY TOOK PLACE
BETWEEN 2009 AND 204 AND
ACTUALLY IDENTIFIED THE MEDIAN
PATIENT AGE OF VULVODYNIA IS 29.
THAT'S REALLY QUITE YOUNG. 90%
OF THE PATIENTS WERE DIAGNOSED
WITH VES TIBIA BUY LOW DIN YA IN
THE REGISTRY AND 90% WERE
DIAGNOSED WITH PELVIC FLOOR
DYSFUNCTION. AND MOST COMMON
TREATMENTS WERE CREAM, THERAPY,
AND THEN TRY CYCLIC
ANTIDEPRESSANTS OR
ANTICONVULSANTS LIKE GABAPENTIN
WERE THE THIRD MOST COMMON
TREATMENT. AFTER SIX MONTHS
THERE WAS REDUCED PAIN AND
PSYCHOLOGICAL DISTRESS WHICH IS
GREAT NEWS, HOWEVER, THEY
REPORTED NO IMPROVEMENT IN
SEXUAL FUNCTIONING WHICH IS
DISTURBING NEWS. NEXT SLIDE,
PLEASE. SINCE MEDICAL SCHOOLS
AND RESIDENCY PROGRAMS DID NOT
INCLUDE INFORMATION ON
VULVODYNIA IN THEIR PROGRAMS AT
THE TIME OF THE EARLY DAYS OF
THE NVA, THE NV A DECIDED TO
DEVELOP AN ONLINE SELF GUIDE
TUTORIAL WITH PRE AND POSTTESTS.
THAT WAS THE INFORMATION WAS
GIVEN VOLUNTARILY BY MANY
EXPERTS.
AND ALL THE VULVODYNIA SUPPORT
IS GIVEN BY EXPERTS, IT'S ALL
VOLUNTARY, NON PAID WITHIN SIX
MONTHS OF THE LAUNCH OF THE NVA
TUTORIAL, THERE -- IT BECAME THE
THIRD MOST POPULAR TUTORIAL ON
MEDSCAPE AND TO DATE 50,000
HEALTH CARE PROVIDERS HAVE
AVAILED THEMSELVES OF THE
TUTORIAL WITH 22,000 OF THEM
SUCCESSFULLY COMPLETING THE
POSTTEST. NEXT SLIDE. NVA
SUPPORT DIRECTOR OVERSEES DOZENS
OF SUPPORT LEADERS AND MONITORS
OUR INSTAGRAM PAGES FOR
SELF-HELP STRATEGIES AND
REPUBLISHES EXCERPTS FROM
PREVIOUS NEWSLETTERS AND GIVES
RESOURCES AND THE PATIENTS SAY
THAT REALLY THE NVA WAS AROUND
AND GAVE THEM AN OPPORTUNITY AS
PART OF A LARGER STRONGER
COMMUNITY. IT LIFTS THEM UP AND
GIVES THEM HOPE WHEN THEY'RE
LOSING HOPE AND HELPS THEM TO
GET THE CARE THEY NEED WHEN THEY
FEEL LIKE THEY DON'T HAVE
HOPEFULLY LONGER. THE NVA WAS
THERE AT THE VERY BEGINNING AND
WE THANK ORGANIZATIONS LIKE
TIGHT TIPPED FOR TAKING THE
BATON AND CARRYING IT ON. WE
EMPLOY THE NIH TO HELP US WITH
FUNDING AND HELP US GIVE MORE
FUNDING TO RESEARCHERS THAT YOU
WILL HEAR FROM OR HAVE HEARD
FROM TODAY BECAUSE WE NEED MORE
RESEARCH OF THIS TERRIBLE
CONDITION. YES, WE ALSO HELP TO
SUPPORT THE RESEARCH SUMMIT FROM
WHEN YOU HEARD THE WONDERFUL
IDEAS FROM DR. GOLDSTEIN IN THE
FALL OF 2024. THERE'LL
HOPEFULLY BE SOME SPONSORSHIP
FOR THEIR WORK. THANK YOU VERY
MUCH FOR YOUR TIME.
>> THANK YOU SO MUCH FOR THAT.
DEFINITELY WORTH THE WAIT. I AM
SURE OUR AUDIENCE IS VERY GLAD
TO HEAR THOSE RESOURCES. I AM
CERTAIN WE CAN PUT A LINK IN THE
Q&A AS WELL TO THE NVA, THANK
YOU SO MUCH DR. KELLOGG SPADT
FOR BEING HERE. WITH THAT
SESSION ONE IS COMPLETE AND I
WILL TURN IT OVER TO DR. HELENA
TO MODERATE THE NEXT SESSION.
>> THANK YOU SO MUCH. LET'S
START SESSION TWO. THE FIRST
SPEAKER IS MR. ZACHARY LYON THE
CEO AND PRESIDENT OF H 3 PELVIC
THERAPY SYSTEM THAT INCLUDES
YEARS OF PRODUCT DESIGN AND
ENGINEERING EXPERIENCE IN
AUTOMOTIVE AND INDUSTRIAL AND
MEDICAL DEVICE PRODUCT AND
ENGINEERING. MR. LYON IS
COLLABORATING WITH ANOTHER
DOCTOR FOR ADVANCED CONTROL AND
MONITORING OF THE TISSUE
TEMPERATURE. MR. LYON IS VERY
EXCITED TO BE PRESENTING
INNOVATIVE, SAFE AND HIGHLY
EFFECTIVE METHODS OF
NONPHARMACOLOGICAL PAIN
MANAGEMENT. MR. LYON, THE FLOOR
IS YOURS.
>> THANK YOU HELENA, CAN
EVERYONE HEAR ME OKAY?
>> YES.
>> YES, I AM CEO/FOUNDER OF H 3
PELVIC THERAPY SYSTEMS. WE ARE
TRYING TO HELP FOLKS WITH DEEPLY
AGGRAVATING PELVIC PAIN
CONDITIONS. USING PHYSICS. THE
THERAPY THAT WE COIN TNT. WE
KNOW THAT, WHOOPS, HANG ON A
SEC. IS IT TRANSFERRING? HANG
ON. LET'S SEE. IT IS NOT
MOVIN
MOVING.
>> YOU HAVE TO CLICK ON THE
ACTUAL PRESENTATION TO ACTIVATE
THE SLIDE.
>> SORRY, GUYS. ANYWAY, WE ARE
IN A -- A VICIOUS CYCLE OF
PELVIC PAIN IS TORMENTS, IT'S
EXPENSIVE AND THE MEDICATIONS
ARINGING A DWRA -- ARE AGGRAVAT.
IT'S FRUSTRATING FOR PHYSICIANS.
PHYSICIANS ARE VERY CHALLENGED
TO TRY TO FIND OUT WHAT MIGHT BE
CAUSING THEIR PATIENT'S
CONDITIONS IN THE VERY LITTLE
TIME THAT THEY HAVE TO TREAT
THEM.
AND SOME OF THESE PATIENTS END
UP IN THE HOSPITAL, IN THE
EMERGENCY ROOM LOOKING FOR HELP
AND DON'T GET HELP AND THAT'S
MANY TIMES NOT RIGHT PLACE FOR
THESE TYPES OF CONDITIONS SO
IT'S A HUGE EXPENSE TO THE
HEALTH CARE SYSTEM. SO WE DID A
SURVEY TO ON AN OUR OWN TO
DISCOVER THESE LOCATIONS OF USER
GROUPS AND SHARING COMMUNITIES
OF HOW CONSTANT IS YOUR PAIN AND
OVER 85% OF 50 CORRESPONDENTS
SAID CONSTANT AND DAILY SO IT'S
EXTREMELY AGGRAVATING THE TOP
TWO QUESTIONS, IN YOUR SEARCH
FOR PAIN AND HEALING WHAT IS
YOUR BIGGEST CHALLENGE? THE
PAIN THAT WON'T GO AWAY AND LACK
OF DOCTOR UNDERSTANDING WHICH
WAS INTERESTING BUT NONETHELESS
WHEN YOU ASK HOW MUCH THEY SPENT
TRYING TO GET RESOLUTION 61%
SPENT A LOT OUT-OF-POCKET.
THESE CONDITIONS MIGHT UNDERLIE
THE PAIN INDUCING STATE ARE
EXTREMELY EXPENSIVE THE GREEN
LINE THAT YOU SEE HERE IS AN
AREA THAT WE'RE VERY INTERESTED
IN AND PART OF WHERE WE'RE GOING
WITH OUR GRANT. THE OTHER ONES
WITH QUESTION MARKS ARE AREAS
THAT WE THINK WE CAN TILL HAVE
SOME IMPROVEMENT AND YOU WILL
LEARN TO UNDERSTAND THAT AS WE
GO OY LONG. THE COST BURDEN IS
HUGE WHEREAS ONE IN FIVE WOMEN
AND ONE OUT OF TWELVE MEN AT
SOME POINT IN THEIR LIFETIME
WHEN THEY GET CHRONIC PELVIC
PAIN CONDITIONS IT BECOMES VERY
EXPENSIVE THE CHALLENGE IS
HOW -- WHEN YOU TAKE OVER 26
DAYS TO SEE YOUR DOCTOR, YOU'RE
SUFFERING IN PAIN FOR THAT
PERIOD OF TIME IF YOU DON'T HAVE
ANY WAY TO ABATE. HOW DO WE
TRANSFER THAT AND THE
FRUSTRATION THE PHYSICIAN HAS
DUE TO THE BRIEF PERIOD OF TIME
HE HAS TO SEE YOU AND THAT
THEY'LL BE DROPPING INTO
GRATITUDE AND TRANSFER THAT INTO
IMMEDIATE RELIEF NOT... ANYWAY.
THERMAL NEUROMODULATION THERAPY
IS THE TECHNIQUE TO MANAGE THESE
TYPES OF PAIN. WE ALL KNOW THAT
THERMAL THERAPY WORKS WELL WHERE
WE'RE ABLE TO HARNESS WARM TO
HOT, HOT TO COLD, AD NAUSEAM FOR
ANY PARTICULAR PROTOCOL THAT WE
MAY CONFIGURE IN THE FUTURE.
THIS IS IMPORTANT. BECAUSE FOR
THE COLD SIDE WE KNOW
INFLAMMATION DRIVES PAIN IF WE
ADDRESS THE ROOT CAUSE OF THIS
INFLAMMATION WE KNOW WE ARE
SHUNTING THE PAIN. IN THE CASE
OF THE TRPM8 CHANNELS WE ARE
AFFECTING THE VOLTAGE OF THE
NEURONS TO SHUNT THE RECEPTORS.
AND IT ALSO ELICITS INFLAMMATORY
FUNCTIONS WHICH IS EVEN MORE
BENEFICIAL TO THOSE THAT ARE
SUFFERING FROM INFLAMMATION-TYPE
CONDITIONS. WE ALSO ARE ABLE TO
CYCLE DUE TO THE CYCLICAL STATE
OF OUR THERMAL MODULATION
THERAPY UP, ABOVE AND BELOW CORE
BODY TEMPERATURE AND THIS IS A
KNOWN PHENOMENA OF ACCELERATING
HUMAN BODY HEALING FOR THOSE
SITUATIONS WHERE WE MAY HAVE
WOUNDS OR SORES THAT NEED TO
RAPIDLY HEAL THEY NEED TO HEAL
MUCH QUICKER THAN THEY CAN
WITHOUT THIS TYPE OF INFLUENCE
WE'RE ABLE TO HELP THOSE
CONDITIONS AS WELL. WHY DOES
THIS MATTER? THIS MATTERS
BECAUSE OUR DEVICES CAN CARRY
THAT SAME COOLING THERAPY.
WE'RE ABLE TO INTRODUCE THAT
INTO THE VAGINAL LUMEN FOR THOSE
THAT ACCEPT A TAMPON SIZE PROBE
TO GIVE COOLING ENERGY. THIS IS
A CONSOLE ANALYTICAL STUDY OF
PERFUSE TISSUES WITH OUR
SIMULATED DEVICE TRANSMITTING
THERMAL ENERGY INTO THE TISSUES
IN THE PELVIC REGION THE STUDY
THAT WE'RE DOING WITH DUKE
UNIVERSITY IS TO UTILIZE RAID I
DON'T MEAN TRY, HOW DEEP WE'RE
ABLE TO TRANSMIT THE ENERGY,
WHETHER COLD OR WARM INTO THESE
HIGH DENSE SENSITIZED REGIONS OF
THE HUMAN PELVIC CAVITY
ANATOMIES THE PRACTICAL
APPLICATIONS AS WE SAW BEFORE IS
A SIMPLE TAMM TAMM RESPONSE
SIZED DEVICE.
AS WE CAN SEE HERE IN THE
THERMAL IMAGE.
YOU CAN SEE HOW THIS COOLING
ENERGY DELIVERS DIRECTLY INTO
THE PARTICULAR SILVER PLATEDED
PROBE WITH NO ELECTRICITY, NO
FLUID WHATSOEVER.
SIMPLE ENERGY ALTHOUGH DELIVERED
VERY, VERY RAPIDLY. SO THE
RELEVANT ANIMAL MODEL WE MIGHT
STUDY THIS IN IS THE SWIPE DUE
TO THE RELATIVE SCALE OF THE
SUBJECTS. SO AS YOU CAN IMAGINE
THE HUMAN DEVICE AND THE SWINE
DEVICE IS QUITE DIFFERENT SO WE
HAVE TO ISOLATE THE AREA FROM,
I'M GOING TO RUN THIS THERMAL
ANALYSIS SO YOU CAN SEE HOW THE
PIG PROBE WORKS WE'RE SIMULATING
THE COOLING ENERGY AT THE BASE
OF THE PROBE AND HOW IT
TRANSFERS THAT TO THE FOCAL
POINT OF WHAT WOULD BE THE HUMAN
PROBE THAT YOU SAW IN THE
SMALLER UNIT AND WE HAD TO
DESIGN SUCH A THING AS THIS
BECAUSE IF YOU LOOK AT THE
ANATOMY OF THE SWINE YOU WILL
SEE THE BLADDER IS MUCH, MUCH
DEEPER IN THE WAY FROM THE HUMAN
IN RELATION OF THE HAVE A
VAGINA TO THE BLADDER.
THIS A CROSS SECTION SHOWING HOW
WE WILL PLACE THE SENSORS TO GET
THE DATA. IT'S KIND OF
COMPLICATED BUT WE WANT TO KNOW
HOW DEEP AND WHAT'S THE RADIAL
OUTPUT OF THIS THERMAL ENERGY
INTO THE DEEPLY INNERVATED OF
THE PELVIC CAVITY. SO,
COMMERCIALLY, THIS IS AN EXAMPLE
OF WHAT A SYMPTOM OF THIS MIGHT
LOOK LIKE. AND OUR
FORWARD-THINKING WOULD BE A
PERSONAL HOME DELIVERED DEVICE
THAT'S UTILIZED IN THE DIGNITY,
THE SANCTITY, THE PRIVACY OF
ONE'S HOME WHERE THEY'RE STAYING
OUT OF THE EMERGENCY ROOM. THE
PHYSICIAN CAN HAVE THIS
DELIVERED TO THE PATIENT AND
THEY CAN BE ON THEIR WAY TO AT
LEAST PAIN MANAGEMENT IF NOT
RECOVERY. THE PROBE IS OUR
CURRENT FOCUS IN THE RESEARCH
PROJECT FOR THOSE THAT CAN
ACCEPT SUCH A DEVICE AND REALIZE
THE COOLING OR THE WARP D --
WARMING.
PELVIC INFLAMMATORY DISEASE,
THESE ARE AREAS OF STUDY THAT
WE'LL FOCUS ON IN THE FUTURE.
THIS IS JUST THE NEXT GENERATION
UNIT WHERE WE WOULD HAVE A
MUCH -- THIS WILL BE A MUCH
SMALLER UNIT BUT IT'S
SELF-CONTAINED AND DESIGNED FOR
LOWER RESOURCE SETTINGS. THIS
AN EXAMPLE OF OUR FORWARD
THINKING AND THIS IS HOW WE KNOW
WHAT WE KNOW WE BUILT MANY OF
THESE SYSTEMS. WE SHIPPED THEM
TO LOCAL PHYSICIANS WHO ASKED US
FOR THEM. FOLKS WHO FOUND US ON
USER GROUPS HAVE REACHED OUT TO
US. WE KNOW WHAT WE KNOW
BECAUSE THEY REACHED OUT AND
THERE'S BEEN INTERESTING
TESTIMONIALS AND I WANT TO PLAY
A QUICK SHORT 45 SECOND VIDEO
MONTAGE HERE IF THIS WILL COME
UP. .
>> IT SEEMS LIKE A LITTLE BIT OF
SOMETHING CHANGED WITH YOU
POSSIBLY.
>> YEAH. BECAUSE I DON'T NEED
THE MACHINE THAT MUCH ANYMORE.
YOU CAN'T HAVE IT BACK.
>> THERE MUST BE A BETTER WAY TO
DO THIS. IN THE PROCESS OF WHAT
WE SAW IN MY ISSUE, AFTER HAVING
KIND OF COME UP WITH THIS IDEA,
AND RESEARCHING NOT JUST MY
ISSUE, MY ISSUE'S MINOR COMPARED
TO -- ALL THE OTHERS THAT YOU
GUYS ARE REALLY AWARE OF AND I
BECAME AWARE OF HOW BIG THIS IS
AND HOW IT MIGHT REALLY IMPACT
THE WORLD OF PELVIC PAIN.
>> OKAY. THANK YOU, I JUST
WANTED TO SHARE THAT REAL QUICK
BECAUSE I THINK THAT'S A GOOD
EXAMPLE. WHERE WE ARE TODAY AS
FAR AS TRACTION IS CONCERNED WE
WERE FORMED IN 2020, IN 2022 WAS
THE YEAR OF DISCOVERY WE APPLIED
FOR MULTIPLE PATENTS. IN 2022
WHERE WE HAD TO PERSEVERE WE HAD
TWO REJECTIONS WITH THE NIH BUT
WE IN 2023 THEY HONORED US WITH
AN AWARD OF A PHASE ONE WE DID
APPLY FOR A THIRD PATENT IN
2022. IN YEAR TO YEAR WE ARE
MOVING FORWARD. WITHOUT THE
HEAL GRANT THIS WOULD NOT BE
POSSIBLE. WE HAVE
REPRESENTATION IN MARKETING,
TECHNOLOGY, FULL STACK
DEVELOPMENT, SALES, QUALITY
SYSTEMS, REGULATORY ADVISORIES
AS WELL AS SMALL BUSINESS
EXPERTISE. I'M HERE TODAY
BECAUSE WE HAVE A REALLY
INTERESTING SYSTEM THAT MAY HAVE
PREDICATES BUT IT MAY NOT HAVE
PREDICATES AND WE WOULD LIKE TO
CONNECT WITH THE FDA TO
UNDERSTAND HOW DO WE MOVE THIS
PRODUCT THAT SEEMS TO WORK
REALLY WELL INTO THE COMMERCIAL
SPACE AS RAPIDLY AS POSSIBLE?
IT IS A NONSIGNIFICANT RISK TYPE
DEVICE. WE CAN TELL AND I THINK
A TREMENDOUS NUMBER OF PEOPLE
COULD BENEFIT FROM IT. ON THAT
PAGE THAT HAS TO DO WITH CODES
AND I WON'T GET INTO THAT TODAY.
WE ARE LOOKING TO CREATE A NEW
STANDARD OF CARE OF HOW WE TREAT
PELVIC PAIN CONDITIONS. SAVING
HEALTH CARE COSTS, KEEPING
PEOPLE OUT OF THE EMERGENCY
ROOM, LET THEM TREAT AT HOME,
WITH TIME RESOLVING SOLUTIONS
THEY DIDN'T GET INTO THESE
PELVIC PAIN CONDITIONS OVERNIGHT
AND THEY WILL PROBABLY NOT GET
OUT OF THEM OVERNIGHT EITHER BUT
GIVING THEM A TOOL THAT HELPS
THEM TO MANAGE THEIR OWN PELVIC
PAIN TO POTENTIALLY BE RESOLVED
OVER TIME IT WOULD BE A
WONDERFUL, WONDERFUL THING AND
THAT'S OUR ULTIMATE GOAL HELPING
PATIENTS IMPROVE THE HEALTH CARE
SYSTEM AND I THANK YOU FOR
EVERYONE'S TIME.
>> THANK YOU SO MUCH MR. LYON.
I SEE THAT. WE HAVE ONE
QUESTION. FROM THE AUDIENCE.
WHAT IS DEVICE MADE OF?
>> WHICH DEVICE ARE WE TALKING
ABOUT? THE PROBE ITSELF OR THE
SEAT?
>> CAN YOU SEE THE Q&A BOX?
>> LET'S SEE. Q&A. WHAT IS THE
DEVICE MADE OF? THE ACTUAL SEAT
WOULD BE BIOCOMPATIBLE. IT IT
WOULD BE OF A FOAM MATERIAL
THAT'S ALREADY KNOWN TO BE
MEDICALLY BIOCOMPATIBLE, THE
MEMBRANE -- THE LATEX MEMBRANE
BUT FOR THOSE WITH A LATEX
ALLERGY WE HAVE REPLACED IT WITH
NEOPREEN OR VINYL TYPE MEMBRANES
THE ACTUAL PROBE ITSELF IS A
SILVER PLAITED BIOCOMPATIBLE
MATERIAL AND IT'S VERY SAFE FOR
THE MOST PART. ANY OTHER
QUESTIONS?
>> THANK YOU. I HAVE ONE
QUESTION, MR. LYON. BUT IT'S
ALREADY IF:40IT'SALREADY AALREA0
IF:40ALREADY ITALREADY I'ALSALR
ALREADY IF:40 -- 3:40 I CAN ASK
A QUESTION LATER. IF WE SEE
MORE QUESTIONS CAN YOU ADDRESS
THEM IN THE Q&A BOX?
>> I WILL DO THAT.
>> THANK YOU SO MUCH.
>> SO OUR NEXT SPEAKER, IS
DR. JOSÉ CAN YOU SHARE YOUR
SLIDES WHILE I'M INTRODUCING
YOU? SO THE DOCTOR IS A FOUNDER
OF A PELVIC FLOOR FIRM
SPECIALIZING IN WIRELESS MEDICAL
DEVICES. AT BOLD TYPE JOSÉ
LEADS A TEAM OF DESIGNERS WITH
EXPERTISE IN THE INDUSTRY OF
DESIGN, MECHANICAL ENGINEERING,
MOBILE APPS, CLOUD
INFRASTRUCTURE, CYBER SECURITY
AND DATA ANALYTICS. DR. B., THE
FLOOR IS YOURS.
>> THANK YOU AND CAN EVERYBODY
HEAR ME?
>> YES.
>> ALL RIGHT, GREAT. SO, YES,
MY NAME IS DR. JOSÉ I'M
PRESIDENT OF BOLD TYPE AND I'LL
BE PRESENTING ON A DEVICE TO
TREAT HIGH TONE PELVIC FLOOR
DYSFUNCTION IN WOMEN. THIS
RESEARCH IS FUNDED BY THE NIH
UNDER A PHASE ONE SPAR GRANT. A
BIT ABOUT THE LEADERSHIP TEAM SO
AS I MENTIONED ON THE PI MY
BACKGROUND IS IN ELECTRICAL
ENGINEERING I GOT ABOUT 20 YEARS
IN THE MEDICAL DEVICES SPACE.
VERY CLOSE COLLABORATOR ON THE
PROJECT AS DR. ERIN CAREY REALLY
THE INVENTOR OF THIS TECHNOLOGY.
THIS IS HER BRAINCHILD A FORMER
PRESIDENT OF THE INTERNATIONAL
PELVIC PAIN SOCIETY AND
PROFESSOR AT UNC. AND THEN ALSO
INVOLVED IN THIS PROJECT IS OUR
CHIEF SOFTWARE ARCHITECT
MOHAMMED, OUR CHIEF OPERATING
OFFICER ANDRES, AND JACKIE AND A
TEAM OF FIVE OTHER ENGINEERS
HAVE PARTICIPATED ON THIS
PROJECT. SO AS WE'VE BEEN
DISCUSSING OVER THE COURSE OF
THE DAY OUR -- THE DEVICE THAT
WE'RE DEVELOPING IS DESIGNED TO
TREAT PELVIC FLOOR DYSFUNCTION
AS A BROAD CATEGORY, PELVIC
FLOOR DYSFUNCTION CAN BE PAIN OR
INCONTINENCE CAUSED BY DID
MUSCLES IN THE PELVIC FLOOR
BEING TOO TIGHT OR TOO LOOSE.
AND WE ARE GOING TO TALK ABOUT
TOO TIGHT CAUSING CHRONIC PAIN.
IT'S A LARGE PROBLEM AS HAS BEEN
DISCUSSED THERE'S A VARIETY OF
SOURCES. THAT GIVE US METRICS
ABOUT HOW LARGE IT CAN BE BUT
IT'S ESTIMATED THAT 37 MILLION
IN THE U.S. SUFFER FROM
DYSFUNCTION OF WHICH ABOUT 30
MILLION WOULD BENEFIT FROM MY
OWE NATIONAL RELEASE THERAPY OF
THOSE 30 MILLION UNFORTUNATELY
ONLY ABOUT HALF SEEK TREATMENT.
AND OF THOSE 15 MILLION TEN
MILLION ACTUALLY INITIATE PELVIC
FLOOR THERAPY AND ABOUT FIVE
MILLION COMPLETE IT. AS WE
DISCUSSED OVER THE COURSE OF THE
DAY THE IMPACT OF CHRONIC PELVIC
PAIN ON PATIENTS' LIVES ARE
SUBSTANTIAL AND CAN BE THINGS
LIKE PREVENTING PHYSICAL
ACTIVITY, DECREASING SEXUAL
ACTIVITY, IT CAN RESULT IN POOR
RELATIONSHIP DYNAMICS, HIGHER
RATES OF ANXIETY AND HIGHER
RATES OF DEPRESSION. AT THE
START OF THIS PROJECT DR. CAREY
INTERVIEWED OVER A HUNDRED
PEOPLE AND WE HAVE A FEW QUOTES
HERE FROM SOME OF THOSE PATIENTS
THE TOP ONE HERE SHOWS PELVIC
FLOOR (READING). I THINK THIS
IS JUST PROBABLY RESONATES WITH
A LOT OF THE PARTICIPANTS TODAY
AND SOME OF THE PRESENTATIONS
GIVEN EARLIER. SO FIRST LINE OF
TREATMENT FOR THESE TYPES OF
CONDITIONS IS PELVIC FLOOR
PHYSICAL THERAPY AND A SESSION
OF PELVIC FLOOR PHYSICAL THERAPY
MIGHT INCLUDE PHYSICAL
EDUCATION, MANUAL THERAPY, AND
THEN ALSO SOFT TISSUE
MANIPULATION WITH MECHANICAL
WANDS SO HERE ON THE TOP RIGHT
IS AN EXAMPLE OF DR. CAREY
SHOWING WHAT A MECHANICAL WAND
WOULD LOOK LIKE AS ITS INSERTED
INTO THE PELVIC MUSCLES.
UNFORTUNATELY FEWER THAN 33%
WOMEN PRESCRIBED THIS COMPLETED
AND THE REASONS ARE VAR RID IF
WE LOOK AT THOSE BARRIERS AND
PUT THEM INTO TWO CATEGORIES.
ON THE LEFT WE SAY WHAT ARE THE
BARRIERS OF GOING TO A THERAPIST
THOSE INCLUDE TIME CONSTRAINTS,
TRAVEL ISSUES AND FEAR OF COURSE
IF WE COULD REDUCE THOSE
BARRIERS THAT WILL HELP DRIVE
GREATER ADHERENCE ON THE HOME
THERAPY SIDE OF THINGS HERE'S
JUST A FEW COMMENTS FROM SOME OF
THOSE PATIENTS WHO WERE
INTERVIEWED SO ONE PATIENT SAID,
I DON'T KNOW WHERE I AM DURING
INTERNAL WORK. THIS WOULD BE
WITH A MECHANICAL WAND. I'M NOT
SURE HOW MUCH PRESSURE I'M
PUTTING. I WAS WORRIED I WAS
GOING TO MAKE SOMETHING WORSE.
SO CLEARLY A LARGE BARRIER TO
PATIENTS DOING THIS TYPE OF
THERAPY AT HOME IS A LACK OF
UNDERSTANDING AND UNCERTAINTY
ABOUT WHETHER THEY'RE DOING
THE -- PERFORMING THE THERAPY
CORRECTLY. SO WE'VE ENVISIONED
AND PROPOSED AND ARE CURRENTLY
DEVELOPING A SYSTEM THAT WE
REFER TO AS A SMART WAND SYSTEM.
IT INCLUDES SMART MECHANICAL
WAND WITH A NUMBER OF SENSORS
INSIDE THAT INDICATES THROUGH
BLUETOOTH THROUGH THE PATIENT'S
CELL PHONE. DATA FROM THE
THERAPY AND THE INTERACTION CAN
BE SENT TO THE CLOUD THROUGH
WI-FI OR CELLULAR AND THEN ON
THE BACK END, WE PLAN TO DEVELOP
A PHYSICAL THERAPIST WEB
APPLICATION THAT THEY CAN USE TO
INTERFACE WITH THE PATIENT. OUR
GOAL IS NOT TO TRY TO REPLACE
PELVIC FLOOR PHYSICAL THERAPISTS
BUT TO SUPPORT THEM IN THEIR
TREATMENT OF PATIENTS AND TO
BRING SOME OF THAT THERAPY INTO
THE HOME WHILE STILL HAVING SOME
OF THE THERAPY BEING PERSON TO
PERSON. SO JUST TO GIVE YOU AN
IDEA OF HOW WE ENVISION THAT
RELATIONSHIP IF WE START WITH
THE VISIT TO THE PELVIC FLOOR PT
THE PATIENT WOULD GET AN
EXERCISE PLAN AND THEN THE
SYSTEM WOULD BE SET UP SO THE
DEVICE WOULD BE SET UP FOR THE
PARTICULAR PATIENT BY THE PT.
AND I'LL GIVE YOU AN IDEA OF HOW
THAT WORKS IN A COUPLE OF SLIDES
AND THEN THE PATIENT COULD DO
SOME OF THOSE EXERCISES AND SOME
OF THAT THERAPY AT HOME. THE
APP WOULD TRACK ADHERENCE AND
THEY'D BE ABLE TO ANSWER
SYMPTOMATIC REPORTS AND THEN
BACK TO THE PHYSICAL THERAPIST
THEY WOULD BE ABLE TO TRACK THE
ADHERENCE OF THE PATIENTS,
EVALUATE SYMPTOMATIC PROGRESS
REPORTS AND ADJUST THE EXERCISE
PLANS AND THERAPY AND
ESSENTIALLY REPROGRAM THE DEVICE
FOR THAT ANY THERAPY FOR THE
PATIENT. SO HERE'S THE GENERAL
OBJECTIVE SO TODAY, WHEN
PATIENTS ARE PRESCRIBED PHYSICAL
THERAPY THEY'RE PRESCRIBED
TWELVE WEEKS OF IN-PERSON WEEKLY
SESSIONS AT THE OFFICE AND THREE
DAYS A WEEK PATIENTS ARE
SUPPOSED TO DO SOME OF THESE
EXERCISES AT HOME. ABOUT 50% OF
PATIENTS MAY MAKE IT TO THE
SECOND SESSION.
AND AND ONLY SOME COMPLETE THESE
RATHER THAN HAVING TWELVE OF THE
VISIT TO THE PT YOU CAN REDUCE
THAT TO FOUR. AND THEN THE
OTHER EIGHT WOULD BE DONE VIA
TELEHEALTH WITH THE PHYSICAL
THERAPIST TO EVALUATE HOW THE
PATIENT IS DOING AND RATHER THAN
THREE SESSIONS UNGUIDE THEY CAN
DO IT IN A GUIDED FASHION.
WHAT WE EXPECT IS THAT THERE'LL
BE GREATER ADHERENCE BECAUSE OF
THE GUIDANCE AS PROVIDED BY THE
SMART WAND. THAT IS GOING TO BE
MORE COMFORTABLE AND MORE
CONVENIENT FOR THE PATIENT AND
THAT YOU'RE GOING TO GET... HAVE
AN OPPORTUNITY TO HAVE SUPPORT
SUCH AS EDUCATIONAL CONTENT IF
WE LOOK INSIDE THE WANT IT'S
FILLED WITH A VARIETY OF SENSORS
SO AT THE TIP OF THE WAND OR AT
THE SECTION THAT'S INSERTED INTO
THE VAGINA THERE'S SENSORS.
THERE'S A NUMBER OF STRAIN
GAUGES ON THE WAND THAT CAN
ACCURATELY MEASURE THE AMOUNT OF
FORCE BEING APPLIED AND THERE'S
ALSO A THREE AXIS ACCELEROMETER
THAT CAN MEASURE THE ROTATION OF
THE WAND AS IT'S INSERTED INTO
THE MUSCLES. OR INSERTED INTO
THE VAGINA. HERE'S A
PRELIMINARY COMMERCIAL APP
DESIGN SO THE IDEA HERE AS YOU
CAN SEE IS THAT THE PATIENT IS
GUIDED AS TO HOW TO INSERT THE
WAND AND HAVE THE PROPER AMOUNT
OF FORCE. THIS IS THE
COMMERCIAL VERSION OF THE APP
THAT WE'RE DEVELOPING AT THE
MOMENT WE'VE COMPLETED
DEVELOPMENT OF THE PRELIMINARY
PROPERTY PROTOTYPE AND WE'RE
DOING A HUMAN STUDIES. AND
WE'RE WORKING WITH TEN HEALTHY
CONTROLS AND I WILL SHOW YOU NOW
A DEMONSTRATION OF THE APP
THAT'S BEING USED IN THE
CLINICAL RESEARCH.
>> THIS IS A SMART WAND. IT CAN
MEASURE INSERTION DEPTH, ANGLING
OF ORIENTATION, AND PRESSURE
APPLIED. A PHYSICAL THERAPIST
WOULD INSERT THIS INTO THE
VAGINA TO THE DESIRED DEPTH,
POSITION IT AT THE RIGHT ANGLE
AND APPLY THE DESIRED AMOUNT OF
PRESSURE AND AT THAT POINT SET
IT. THIS WILL SET A TARGET FOR
THE PATIENT TO PLACE THE WAND IN
THE RIGHT PLACE FOR THE RIGHT
MUSCLE AND APPLY THE APPROPRIATE
AMOUNT OF PRESSURE IF WE GO TO
THE PATIENT SCREEN HERE THE
PATIENT IS SHOWN THE MUSCLE THAT
THEY WILL BE TREATING. WE CAN
SELECT START. AND NOW THE
PATIENT'S GOAL IS TO HAVE THE
CIRCLE REACH ITS TARGET DEPTH,
THE WAND BEING THE RIGHT ANGULAR
ORIENTATION AND THE AMOUNT OF
FORCE APPLIED TO BE AT THE RIGHT
LEVEL. ONCE THEY REACH THAT
TARGET, THEY HOLD THAT POSITION
FOR TEN SECONDS. AND NOW IT'S
COMPLET
COMPLETED.
>> ALL RIGHT. SO, AGAIN, DURING
THE PERIOD OF TIME OF STUDIES
THAT WE'RE CONDUCTING WE'RE
LOOKING AT SIX DIFFERENT
MUSCLES, THREE ON EITHER SIDE
AND, YOU KNOW, JUST TO GIVE YOU
A SENSE OF HOW THIS WORKS IN A
SLOWER FASHION WHEN THE PATIENT
FIRST GRABS THE WAND BEFORE
INSERTING IT THIS WOULD SHOW OFF
TARGET IF YOU WILL. AS THE
PATIENT INSERTS IT MORE DEEPLY
INTO THE VAGINA THE GRAY CIRCLE
REACHES THE TARGET AND TURNS
GREEN. THAT LETS THE PATIENT
KNOW THEY INSERTED IT
SUFFICIENTLY DEEP AND THEN THEY
HAVE TO HAVE THE BARS TO THE
DOTTED LINE. AS THEY ROTATE THE
WAND YOU WOULD BE ON TARGET AND
THEN YOU APPLY FOR SOME PRESSURE
AND THAT'S WHAT YOU SEE IN THE
PINK CIRCLE THAT THAT CIRCLE
RADIATES AND GROWS UNTIL IT
REACHES THE TARGET AMOUNT OF
FORCE AT THAT TIME THE COUNTDOWN
TRIGGERS AUTOMATICALLY AND AS
LONG AS THE PHYSICAL THERAPIST
SETS IT UP FOR THAT AMOUNT OF
PRESSURE THEY HOLD FOR THAT
PERIOD OF TIME. IN SUMMARY OUR
GOAL IS TO BRING PELVIC FLOOR
THERAPY AT HOME WHILE STILL
INCORPORATING THE WISDOM AND
SKILL OF PELVIC FLOOR PHYSICAL
THERAPISTS.
>> THANK YOU SO MUCH, DOCTOR.
IF YOU STOP SHARING YOUR SLIDE
YOU CAN SEE THE Q&A BOX. ANY
CONNECTION BETWEEN LINE AND
VULVODYNIA?
>> GOOD QUESTION AND HERE IS
WHAT I WILL GIVE YOU THE CAVEAT
OF WHAT MY KIDS LIKE TO SAY I AM
NOT A REAL DOCTOR I'M JUST AN
ENGINEERING PH.D. I HAVEN'T SEEN
THE WORK THAT WE'VE BEEN DOING
WITH DR. CAREY. OUR FOCUS HAS
BEEN WITH CHRONIC PELVIC PAIN.
YOU USE THE WAND LIKE A
MECHANICAL WAND BUT IT'S BEING
GUIDED BY A TARGET SET BY THE
PHYSICAL THERAPIST SO ANYWHERE
WHERE MAYA FASCIA RELEASE TYPE
OF THERAPY CAN BE HELPFUL THIS
CAN BE HELPFUL FOR PATIENTS.
>> THANK YOU, WE HAVE A
LOGISTICAL QUESTION IF THE
APPLICATION IS ON THE PHONE HOW
WILL USERS HOLD THEIR PHONE AND
USE THE WAND SIMULTANEOUSLY?
>> YES, THAT'S A GREAT QUESTION
AND YOU KNOW, WE'RE LOOKING AT
DIFFERENT OPTIONS THERE. WE
THINK, YOU KNOW, ONE POSSIBILITY
FOR, YOU KNOW, EITHER THE
PATIENT COULD ALSO USE A TAB
LAET -- TABLET OR A PHONE AND
MORE THAN LIKELY HAVE A STAND OR
SOMETHING. THE WAND CAN BE
OPERATED WITH ONE HAND BUT MORE
LIKELY IT'LL BE MORE COMFORTABLE
WITH TWO HANDS DID VICE HAS A
BUTTON ON IT AND THE PROTOCOL
THAT WAS SET UP FOR THE PATIENT
IS INITIATED THEY CAN GO FROM
ONE MUSCLE TO THE NEXT JUST BY
PRESSING THE BUTTON ON THE WAND.
SO THEY DON'T NEED TO INTERACT
WITH THE PHONE. THEY JUST NEED
IT FOR THE VISUAL FEEDBACK SO
THEY CAN PUT IT ON THE STAND AND
LOOK AT IT AS THEY'RE GOING
THROUGH THE DIFFERENT MUSCLES.
>> DR. GOLDSTEIN HAVE A
QUESTION. CAN YOU SEE THE CHAT.
>> I HAD THE Q&A OPEN.
>> WHY NOT TARGET PEW BOW RECTAL
LIS AND TRANSVERSE PERRY NIA.
>> THE IDEA OF THIS CAN BE USED
ON ANY PELVIC FLOOR MUSCLES FOR
THE PURPOSES OF A HUMAN STUDY
THIS IS A FIRST PROOF OF STUDY
CONCEPT. WE SELECTED THREE
MUSCLES BUT ABSOLUTELY, ANY OF
THE MUSCLES THAT CAN BE REACHED
INTRAVAGINALLY ARE GOOD
CANDIDATES FOR PELVIC FLOOR
PHYSICAL THERAPY AND THE SMART
WAND WOULD CERTAINLY BE OF USE
FOR THAT.
>> OKAY.
>> THANK YOU SO MUCH, IT'S 3:55
SO WE NEED TO MOVE ON. THANK
YOU SO MUCH DOCTOR.
THANK YOU VERY MUCH.
WE HAVE TWO FDA SPEAKERS THE
FIRST SPEAKER IS DR. REGINALD
AVERY. DR. AVERY CAN YOU SHARE
YOUR SLIDES? (AUDIO CUTTING
OUT). AT THE FDA. AND PRIOR TO
HIS ROLE AS A TEAM LEAD HE WAS A
LEAD REVIEWER IN THE OBSTETRICAL
AND REPRODUCTIVE HEALTH DEVICES
TEAM. DR. AVERY, THE FLOOR IS
YOURS.
>> THANK YOU, HOPEFULLY YOU CAN
SEE MY SLIDES.
>> YES.
>> FWRAECHLT THA GREAT THANK YO
INTRODUCTION AND THE INVITATION.
MY NAME IS REGINALD AVERY AND
I'M THE TEAM LEAD FOR THE
GYNECOLOGICAL DEVICES TEAM IN
THE CENTER FOR DEVICES IN
RADIOLOGICAL HEALTH OR CDRH IN
FDA.
IN THIS PRESENTATION, I WILL TRY
TO BRIEFLY OVERVIEW THAT'S THE
FDA ORGANIZATION AND AGENCY
AUTHORITIES FOR MEDICAL DEVICES,
SURPRISE THE TOTAL PRODUCT LIFE
CYCLE AND HOW MEDICAL DEVICES
REVIEW AND REGULATED BY FDA.
I'LL FOCUS ON PREMARKET
ACTIVITIES BUT CAN'T DISCUSS
POSTMARKET ACTIVITIES AFTER MY
PRESENTATION IF PEOPLE HAVE
QUESTIONS. THE FDA IS A
REGULATORY AGENCY WITH THE
MISSION TO PROTECT AND PROMOTE
THE PUBLIC HEALTH THE STATUTES
AND REGULATIONS LISTED ON THIS
SLIDE ARE SOME OF THE LAWS THAT
GIVE FDA ITS AUTHORITIES. AND
RESPONSIBILITIES BUT ADDITIONAL
REQUIREMENTS AND DEVICE
CLASSIFICATION INFORMATION ARE
ALSO OUTLINED IN TITLE II 1 OF
THE CODE OF FEDERAL REGULATIONS.
FDA IS ORGANIZED INTO DIFFERENT
CENTERS BASED ON MEDICAL PRODUCT
REVIEW AREA.
THE CENTERS INCLUDE THE CENTER
FOR DEVICES AND RADIOLOGICAL
HEALTH OR CDRH WHICH IS WHERE I
WORK. WITHIN CDRH THERE'S THE
OFFICE OF PRODUCTS, EVALUATION
AND QUALITY OR OPEC. AND THAT
IS RESPONSIBILITY FOR THE TOTAL
PRODUCT LIFE CYCLE REVIEW OF
MEDICAL DEVICES.
OUR ROLE IN THIS OFFICE INCLUDES
SUBMISSION REVIEWS TO GET
MEDICAL DEVICES ON THE MARKET AS
WELL AS ACTIVITIES TO MONITOR
COMPANIES AND REVIEW INFECTION
FINDINGS FOR COMPLIANCE ONCE
COMPANIES HAVE DEVICES ON THE
MARKET. LASTLY, WE'LL LOOK AT
WHERE MY TEAM IS HOUSED WHICH IS
WITHIN THE OFFICES OF HEALTH
TECHNOLOGIES OR OHTS IN OPEQ
THERE ARE DIFFERENT OHTS AND
THEY ARE SEPARATED BASED ON
CLINICAL AND ANATOMICAL AREAS MY
TEAM THE GYNECOLOGICAL AND
SURGICAL DEVICES TEAM IS PART OF
OHT3 WHICH IS THE OFFICE OF
GASTRO RENAL, OBGYN, GENERAL
HOSPITAL AND UROLOGY DEVICES AND
IS PART OF THE GYNECOLOGY AND
NEUROLOGY DEVICES. THE DIVISION
I WORK IN ALSO INCLUDES
OBSTETRIC AND REPRODUCTIVE
HEALTH DEVICES LIKE CONDOMS AND
MATERNAL FETAL MONITORS, MALE
AND FEMAAILURE ROLLING DEVICES.N
THIS SLIDE ARE A FEW DEVICES
REVIEWED BY THE GYNECOLOGICAL
TEAMS.
RANGING FROM SURGICAL TOOLS,
DEVICES USED FOR ROUTINE
GYNECOLOGY VISITS AND
OVER-THE-COUNTER PRODUCTS. FOR
TODAY'S PRESENTATION, I WILL
DISCUSS THE THREE MAIN
COMPONENTS THAT TLPC PREMARKET,
POSTMARKET BUT I WILL FOCUS ON
THE PREMARKET ACTIVITIES THE
REVIEW TEAMS WHICH INCLUDE
ENGINEERS, CLINICIANS, NURSES,
MICROBIOLOGISTS, THINK OF TPLC
HAS A HOLISTIC PROCESS WORKING
IN TANDEM AND NOT IN ISOLATION
TO HELP ENSURE THAT THERE ARE
SAFE AND EFFECTIVE MEDICAL
DEVICES ON THE MARKET. BEFORE
DISCUSSING THE PREMARKET WORK, I
WOULD LIKE TO PROVIDE A
DEFINITION OF A MEDICAL DEVICE.
THE OHTS ARE RESPONSIBLE FOR
REVIEWING MEDICAL PRODUCTS THAT
MEET THE DEFINITION OF A MEDICAL
DEVICE AND THAT'S SHOWN ON THIS
SLIDE. THIS LANGUAGE IS FROM
THE FOOD, DRUG AND COSMETIC ACT
AND IT NOTES THAT A DEVICE IS AN
INSTRUMENT, APPARATUS,
IMPLEMENT, ET CETERA, WHICH IS
INTENDED FOR USE IN A DIAGNOSIS
OF DISEASE OR OTHER CONDITIONS
OR IN THE CURE OR PREVENTION OF
DISEASE. OR IS INTENDED TO
AFFECT THE STRUCTURE OR ANY
FUNCTION OF THE BODY IN WHICH
DOES NOT ACHIEVE AS PRIMARY
INTENDED PURPOSES THROUGH
CHEMICAL ACTION. SO THE PIECES
OF THAT DEFINITION THAT I JUST
READ HELP ADDRESS THE INTENDED
USE IN PART B AND THE MECHANISM
OF ACTION PART C OF A MEDICAL
DEVICE. AND IT HELPS
DISTINGUISH DEVICES FROM DRUGS
OR BIOLOGICS. MEDICAL DEVICES
ALSO INCLUDE CERTAIN SOFTWARE
FUNCTIONS, INCLUDING
SOFTWARE-BASED MOBILE, MEDICAL
APPLICATIONS THAT MEET THE
DEFINITION OF A DEVICE. THERE
ARE 3 CLASSES OF MEDICAL DEVICES
AND THEY'RE PLACED BASED ON
THEIR RISK LEVEL AND THE
REGULATORY NEEDED FOR SAFETY AND
EFFECTIVENESS. I WILL GO
THROUGH EACH OF THE CLASSES
SHORTLY. CLASS ONE DEVICES ARE
LOW TO MODERATE RISK. AND
GENERAL CONTROLS ARE NEEDED TO
PROVIDE A REASONABLE ASSURANCE
OF SAFETY AND EFFECTIVENESS.
SOME EXAMPLES OF THOSE GENERAL
CONTROLS ARE REGISTRATION AND
LISTENING REQUIREMENTS.
RECORDKEEPING. AND MEDICAL
DEVICE REPORTING REQUIREMENTS.
CLASS ONE DEVICES MAY BE EXEMPT
FROM 510K SUBMISSIONS WHICH
WE'LL OVERVIEW SHORTLY. NEXT
CLASS TWO DEVICES ARE MODERATE
TO HIGH RISK. AND GENERAL AND
SPECIAL CONTROLS. ARE NEEDED TO
PROVIDE THAT REASONABLE
ASSURANCE OF SAFETY AND
EFFECTIVENESS. SPECIAL CONTROLS
ARE USUALLY DEVICE-SPECIFIC
REQUIREMENTS. AND MAY INCLUDE
NON-CLINICAL TEST REQUIREMENTS
AS WELL AS LABELING
REQUIREMENTS. CLASS TWO DEVICES
TYPICALLY NEED A 510K TO BE
AUTHORIZED FOR MARKETING. DE
NOVOS ARE ANOTHER TYPE OF
SUBMISSION THAT CAN BE USED TO
MARKET CERTAIN CLASS TWO DEVICES
AND I'LL OVERVIEW WHAT A DE NOVO
ENTAILS IN A LATER SLIDE. LAST
CLASS THREE DEVICES ARE ANY HIGH
RISK DEVICES. THESE REQUIRE
GENERAL CONTROLS AND PREMARKET
APPROVAL TO PROVIDE THAT
REASONABLE ASSURANCE OF SAFETY
AND EFFECTIVENESS. AND
ACCORDINGLY A PMA IS THE
ASSOCIATED PREMARKET SUBMISSION
TYPE. ON EACH SLIDE FOR
PREMARKET REVIEWS. I HAVE
INCLUDED A FEW RESOURCES THAT
MAY HELP A MANUFACTURER OR
RESEARCHER UNDERSTAND THE
PREMARKET TOPIC. AND ONE
RESOURCE THAT I DO WANT TO
HIGHLIGHT IS THE PRESUBMISSION
PROGRAM. SO THIS PROGRAM IS A
COMMONLY USED APPROACH FOR
SPONSORS, RESEARCHERS,
INVESTIGATORS OR MANUFACTURERS
TO BEGIN OR CONTINUE TO
COMMUNICATE WITH FDA REVIEW
TEAMS TO HELP FACILITATE
BRINGING A DEVICE TO A MARKET
THE SUBMISSIONS ARE FREE AND ARE
USED TO RECEIVE FEEDBACK ON A
REGULATORY STRATEGY FOR A
DEVICE. APPROPRIATE
NON-CLINICAL TEST PLANS. ANIMAL
TESTING CLINICAL STUDY PROTOCOLS
SOR TO DISCUSS ANY DEFICIENCIES
THAT ACCOMPANY RECEIVED AS PART
OF A PREMARKET REVIEW.
THERE IS NO RIGHT TIME TO SUBMIT
A PRESUBMISSION. IT CAN BE
WHILE YOU'RE IN THE IDEA STAGE
OR WHEN YOU'RE CLOSER TO
FINALIZING YOUR DEVICE DESIGN.
YOU CAN SUBMIT MOST OF THE
PRESUBMISSIONS, THERE'S NO LIMIT
ON THE AMOUNT AND WE REALLY DO
THINK THAT THIS PROGRAM HELPS
ENSURE THAT FDA AND SPONSORS ARE
ALIGNED ON WHAT THE EXPECTATIONS
WILL BE ON THE PREMARKET
SUBMISSION BEFORE THEY GET TO
THAT POINT OF SUBMITTING
WHATEVER THEIR 510K DE NOVO OR
PMA. SO IF YOU ALREADY KNOW OR
WERE INFORMED BY THE REVIEW TEAM
THAT CLINICAL DATA WILL BE
NECESSARY TO SUPPORT A MARKETING
AUTHORIZATION YOU MAY NEED TO
SUBMIT A DEVICE EXEMPTION OR IED
TO STUDY A SIGNIFICANT DEVICE IN
THE UNITED STATES YOU MUST
SUBMIT AN IDE FOR APPROVAL.
THIS CAN BE A FIRST IN HUMAN
STUDY, AS AN EARLY FEASIBILITY
STUDY A PILOT STUDY OR YOUR FULL
PIVOTAL STUDY WHICH IS INTENDED
TO SUPPORT DEVICE SAFETY EFFECT
ANDIVENESS. FDA WILL DETERMINE
WHETHER THESE SUPPORT THE SAFE
USE OF THE DEVICE IN THE
INVESTIGATIONAL STUDY. FDA WILL
ALSO SUPPORT THIS THAT --
EXAMPLES OF THESE CONSIDERATIONS
THAT YOU MAY RECEIVE INCLUDE A
MORE APPROPRIATE PRIMARY END
POINT OR RECOMMENDATION TO
PROVIDE ADDITIONAL BENCH TESTING
TO SUPPORT DEVICE EFFECTIVENESS
IN MARKETING SUBMISSION. NOW
ONCE YOU HAVE ALL OF THE
NON-CLINICAL AND CLINICAL DATA
AS WELL AS THE PROPOSED LABELING
YOU BELIEVE ARE NECESSARY TO
SUPPORT A MARKETING
AUTHORIZATION, YOU'LL SUBMIT
YOUR MARKETING APPLICATION DO
NOVO, 510 (K) ARE THE MOST
COMMON. AND SUBMISSION TYPES
ARE SUBJECT TO A FEE. FIRST,
THE 510K WHICH IS MOST COMMON
PATH WEI FOR GUIDELINE KOE
LOGICAL DEVICE TO RECEIVE
MARKETING AUTHORIZATION.
THE REGULATORY FRAMEWORK 4510K
IS TO DEMONSTRATE AS SAFE AND AS
EFFECTIVE AS A LEGALLY MARKETED
PREDICATE DEVICE OR THAT THE
SUBJECT AND PREDICATE DEVICE ARE
SUBSTANTIALLY EQUIVALENT. AND
WHAT MAKES A DEVICE
SUBSTANTIALLY EQUIVALENT IS WHEN
IT HAS THE SAME INTENDED USE AS
THE PREDICATE DEVICE. IT HAS
THE SAME TECHNOLOGICAL
CHARACTERISTICS AS THE PREDICATE
DEVICE OR IF THERE ARE
DIFFERENCES, THOSE DIFFERENCES
DO NOT RAISE DIFFERENT QUESTIONS
OF SAFETY OF EFFECTIVENESS AND
THEY HELP DEMONSTRATE THAT THE
DEVICE IS AS SAFI SAFE EFFECTIV
THE PREDICATE DEVICE. DE NOVOS
ALLOW ES FDA TO CLASSIFY LOW
RISK DEVICES THAT DO NOT HAVE A
MARKETING PREDICATE PART OF THE
TEAM'S WORK IS TO CONFIRM THERE
IS NO AVAILABLE REGULATION OR
PREDICATE ALREADY AVAILABLE FOR
THE DEVICE BASED ON ITS INTENDED
USE AND TECHNOLOGICAL
CHARACTERISTICS. THE REGULATORY
FRAMEWORK FOR A DE NOVO IS TO
DETERMINE WHETHER GENERAL
CONTROLS AND SPECIAL CONTROLS
ARE ENOUGH TO PROVIDE THAT
REASONABLE ASSURANCE OF SAFETY
EFFECT ANDIVENESS. DEVICES
GRANTED MARKETING AUTHORIZATION
CAN SERVE AS A PREDICATE DEVICE
FOR A FUTURE 510K BECAUSE THESE
ARE CLASS TWO DEVICES. AND A
UNIQUE PART OF A DE NOVO REVIEW
IS THE OPPORTUNITY TO GENERATE A
NEW REGULATION TO HELP DEFINE
THE DEVICE TYPE AND THE
NECESSARY TESTING OR SPECIAL
CONTROLS FOR THAT DEVICE TYPE.
LAST AMONG THE PREMARKET
SUBMISSION TYPES, PMAS WHICH ARE
THE MOST STRINGENT TYPE OF
MARKETING APPLICATION AND ARE
THE REGULATORY SUBMISSION THAT
ALLOWS FDA TO CLASSIFY HIGH RISK
DEVICES INCLUDING LIFE
SUSTAINING OR SUPPORTING DEVICES
THERE ARE NO PREDICATE DEVICES
SO THE SPONSOR WOULD NEED TO
DEMONSTRATE INDEPENDENTLY THAT
THE DEVICE HAS A REASONABLE
ASSURANCE OF SAFETY AND
EFFECTIVENESS. SOME DEVICE
TYPES LISTED IN THE REGULATIONS
ARE ALREADY CLASSIFIED AS CLASS
THREE AS OUTLINED IN THE
REGULATION. AND TYPICALLY THESE
DO REQUIRE SOME CLINICAL DATA TO
SUPPORT SAFETY AND
EFFECTIVENESS. AND ESPECIALLY
FOR FIRST OF ITS KIND DEVICES
THERE CAN BE AN ADVISORY PANEL
WHICH IS A PUBLIC MEETING TO
HELP PROVIDE ADDITIONAL INPUT ON
THE SAFETY AND EFFECTIVENESS
DATA THAT'S BEEN AFFECTED BY THE
COMPANY. THERE IS ONE MORE
SUBMISSION TYPE THAT I'D LIKE TO
SHARE. MANY COMPANIES
DEVELOPING DEVICES ARE
INTERESTED IN OBTAINING
BREAKTHROUGH DESIGNATION WHICH
IS A PROGRAM THAT WAS INITIATED
FROM THE 21ST CENTURY ACT. IT'S
A DESIGNATION THAT PROVIDES
COMPANIES WITH ADDITIONAL
RESOURCE TO HELP EXPEDITE THEIR
DEVELOPMENT AND ALIGN
EXPECTATIONS WITH FDA THIS SLIDE
OUTLINES THE TWO CRITERIA THAT
SHOULD BE MET BY A DEVICE FOR IT
TO ACHIEVE BREAKTHROUGH
DESIGNATION. AND YOU CAN SEE IT
THERE BUT I JUST WOULD LIKE TO
HIGHLIGHT THE FIRST ONE IS THAT
IT NEEDS TO PROVIDE A MORE
EFFECTIVE TREATMENT FOR A
DISEASE OR CONDITION. AND TO
TAKE ADVANTAGE OF THIS PROGRAM'S
RESOURCES A REQUEST FOR
BREAKTHROUGH SHOULD BE SUBMITTED
BEFORE YOU SUBMIT YOUR MARKETING
SUBMISSION AND THIS IS MY LAST
SLIDE. THERE ARE FDA ACTIVITIES
AND MANUFACTURER
RESPONSIBILITIES THAT CONTINUE
AFTER A DEVICE RECEIVES
MARKETING AUTHORIZATION.
SPONSORS DO HAVE REGULATORY
REQUIREMENTS THAT THEY MUST MEET
SUCH AS MDR REPORTING FOR ALL
DEVICES. FDA ALSO HAS THE
AUTHORITY TO INSPECT
MANUFACTURER SITES FOR
COMPLIANCE TO THE REGULATORY
REQUIREMENTS AND CAN TAKE
ENFORCEMENT ACTIONS IF COMPANIES
ARE NOT IN COMPLIANCE. THIS
CONCLUDES MY OVERVIEW OF THE FDA
REVIEW PROCESS FOR DEVICES AND I
LOOK FORWARD TO ANSWERING ANY
QUESTIONS IN THE Q&A OR LATER IN
THE DISCUSSION.
>> THANK YOU SO MUCH DR. AVERY
WE NEED TO MOVE ONTO THE NEXT
SPEAKER MISS MARGARET KOEB ER A
CHIEF MANAGEMENT STAFF IN THE
OFFICE OF REGULATORY OPERATIONS
WITHIN THE OFFICE OF NEW
DRYINGS, CENTER FOR DRUG
EVALUATION AND RESEARCH. AT
FDA. THE FLOOR IS YOURS.
>> THANK YOU, I BELIEVE MY
SLIDES WOULD BE SHARED FOR ME.
I'M DELIGHTED TO BE HERE.
TOWARD THE END OF MY SESSION SO
I HAVE MY WORK CUT OUT FOR ME IN
TERMS OF KEEPING ME AWAKE. YOU
MAY BE WONDERING WHY YOU NEED TO
HEAR FROM TWO PEOPLE FDA PEOPLE
AND THE BASIC ANSWER TO THAT IS
ALTHOUGH WE REGULATE DEVICES AND
THE WAY REGULATE DRUGS HAVE
SIMILARITIES AND THERE'S SOME
DIFFERENCES. WE DO HAVE OUR OWN
SET OF REGULATIONS AND SO THAT
IS WHAT I'M HERE TO HELP
EXPLAIN. THE TITLE OF MY TALK
IS UNDERSTANDING THE IND
PROCESS. THERE IS NO WAY THAT
IF YOU DON'T ALREADY KNOW
SOMETHING ABOUT INDS, THAT
YOU'RE GOING TO UNDERSTAND IT IN
FIFTEEN MINUTES BUT WE'LL DO OUR
BEST. AND BY WAY OF BACKGROUND,
I AM WITH THE OFFICE OF
REGULATORY OPERATIONS, BUT I AM
ALIGNED WITH THE DIVISION OF
UROLOGY, OBSTETRICS AND
GYNECOLOGY SO I AM INVOLVED IN
THE REVIEW OF APPLICATIONS FOR
THOSE TYPES OF INDICATIONS.
NEXT SLIDE, PLEASE. SO WHEN WE
TALK ABOUT INDS, FIRST OF ALL,
IT STANDS FOR INVESTIGATIONAL
ANY DRUG BY YOU'LL OFTEN HEAR IT
ALSO REFERRED TO AS THE
APPLICATION TO STUDY THAT NEW
DRUG. AND WHEN WE SAY NEW DRUG,
IT'S DEFINITELY A DRUG THAT HAS
EVER BEEN APPROVED WOULD REQUIRE
AN IND BUT THERE'S ALSO A
REQUIREMENT THAT COMES INTO
EFFECT IF YOU'RE USING AN
APPROVED DRUG FOR A NEW USE IF
THAT USE WOULD INTRODUCE NEW
RISKS OR MAKE THE EXISTING KNOWN
RISKS LESS ACCEPTABLE. SO
THAT'S WHAT WE'RE TALKING ABOUT
HERE. ANYTIME YOU WANT TO DO A
STUDY TO INCLUDE THESE TYPES OF
PRODUCTS, YOU WOULD SEND IN THIS
APPLICATION. AND WHAT DOES THAT
LOOK LIKE? WELL, THERE ARE
REGULATIONS OUTLINED IN 21 CFR
312.23 FROM THE REGULATORY
ASPECT FOR THE SUBMISSION TO BE
COMPLETE IT MUST INCLUDE AT
LEAST THE COVER LETTER, THE FORM
1571 THAT ALLOWS US TO REVIEW
WHAT YOU SENT IN AND IN THAT
FORM YOU SIGN YOU INTEND TO
FOLLOW ALL THE REGULATIONS. THE
FORM 3674 WHETHER OR NOT YOU'RE
COMPLYING WITH THE REGULATION OF
THE TRIALS. YOU SHOULD INCLUDE
A TABLE OF CONTENTS, AN
INTRODUCTORY STATEMENT AND
GENERAL INVESTIGATIONAL PLAN.
TELL US WHAT YOU HAVE IN MIND
AND THEN IN THERE ARE MULTIPLE
INVESTIGATORS, YOU'LL WANT TO
INCLUDE THE INVESTIGATOR'S
BROCHURE. NEXT SLIDE, PLEASE.
OTHER TECHNICAL SECTIONS ARE THE
NON-CLINICAL. THINGS LIKE BASIC
EXPOSURE DATA. YOU DON'T WANT
TO GO FIRST IN HUMAN WHEN YOU
HAVE NOTHING TO SUPPORT THAT
USE. IN TERMS OF SAFETY THERE'S
ALSO A SECTION ON CHEMISTRY,
MANUFACTURING AND CONTROLS.
THIS MEANS YOU HAVE TO SUPPLY
SUFFICIENT INFORMATION TO ASSURE
THAT YOU CAN PROPERLY IDENTIFY
THE QUALITY, THE PURITY AND THE
STRENGTH, AND THAT THIS PRODUCT
CAN BE MANUFACTURERED IN AN
ADEQUATE FACILITY AND CONSISTENT
FROM ONE BATCH TO ANOTHER
INSOFAR AS POSSIBLE. NEXT
SLIDE. WHAT MOST OF YOU ARE
PROBABLY INTERESTED IN TODAY,
THAT CLINICAL PROTOCOL, FIRST
YOU HAVE TO DETERMINE THE PHASE
OF DEVELOPMENT AND THIS BECOMES
IMPORTANT BECAUSE THE STANDARDS
FOR ALLOWING A STUDY TO PROCEED
WILL BE DETERMINED BY WHAT PHASE
YOU'RE IN. YOU MUST ALSO
PROVIDE ANY SUPPORTING DATA. IN
OTHER WORDS, IF YOU ARE AWARE OF
TRIALS DONE OUTSIDE THE U.S.
YOU'D WANT TO CERTAINLY INCLUDE
INFORMATION ABOUT THOSE TRIALS
AND THEN PHARMACOKINETIC DATA IF
THERE IS ANY, THAT'S ALREADY
BEEN GATHERED, AND YOU WANT TO
ESPECIALLY BE SURE TO ADDRESS
HOW YOU ARE GOING TO ENSURE THE
SAFETY OF PATIENTS AND SUBJECTS
IN THE STUDY. THIS IS THE
NUMBER ONE REASON WHY WE TELL
FOLKS THEIR STUDY MAY NOT
PROCEED. SO BE VERY COGNIZANT
OF THAT, PLEASE. NEXT SLIDE.
AND THE FORMAT, YOU CAN SEND IT
IN IF IT IS A RESEARCH IND
MEANING IT'S BEING CONDUCTED NOT
FOR COMMERCIAL PURPOSES. IT CAN
BE SUBMITTED IN PAPER. THERE IS
ALSO A MECHANISM TO SEND IT
THROUGH AN ELECTRONIC PORTAL.
WHAT YOU CANNOT DO AND I CAN'T
TELL YOU THE NUMBER OF TIMES
PEOPLE TRY TO DO THIS, YOU CAN'T
E-MAIL IT TO US. THAT'S JUST
NOT GOING TO WORK. SO IF IT IS,
HOWEVER, A COMMERCIAL IND THEN
IT MUST BE SUBMITTED
ELECTRONICALLY THROUGH THE
ELECTRONIC SUBMISSIONS GATE WEI
AND IT MUST BE IN COMMON
TECHNICAL DOCUMENT FORMAT. AND
THERE ARE LOTS OF RESOURCES TO
HELP YOU DETERMINE HOW TO DO
THAT. NEXT SLIDE SH, SO ONCE Y
SUBMITTED YOUR APPLICATION WHAT
HAPPENS NEXT? WE ASSEMBLE A
REVIEW TEAM THAT INCLUDES
EXPERTS IN REGULATORY, CLINICAL,
NON-CLINICAL PHARMACOLOGY AND
TOXICOLOGY, CHEMISTRY, CLINICAL
PHARMACOLOGY, BIO STATISTICS,
EVEN IF IT'S THE FIRST THING
WE'VE SEEN FROM YOU IF IT'S A
PHASE THREE PROTOCOL THE
STATISTICIANS WILL DEFINITELY
WANT TO BE INVOLVED AND THEN WE
ALSO BRING IN OTHER EXPERTS
DEPENDING ON THE TYPE OF
PRODUCT. IF IT IS A COMBINATION
PRODUCT THAT INCLUDES A DRUG AND
A DEVICE AND A PRIMARY MODE OF
ACTION IS CHEMICAL RATHER THAN
MECHANICAL, THAT WOULD BE STILL
REVIEWED PRIMARILY BY S CDR BUT
WE WILL CONSULT OTHERS AS WELL.
BOTANICAL RAISE INTERESTING
ISSUES.
WE HAVE A WHOLE TEAM DEVOTED TO
REVIEWING ANYTHING POE DANNAL.
IF YOUR STUDY INVOLVES CHILDREN
WE WILL FREQUENTLY BRING IN OUR
PEDIATRIC EXPERTS AND WE ALSO
HAVE A STAFF OF ETHICISTS WHO
CAN HELP US OUT IN SITUATIONS
WHERE THAT MIGHT BE IMPORTANT
FOR THEM TO WEIGH IN. THE NEXT
SLIDE, PLEASE. SO THE FIRST 30
DAYS IS ALL ABOUT A SAFETY
REVIEW. WE HAVE 30 DAYS FROM
THE DAY WE RECEIVE YOUR
APPLICATION TO DETERMINE WHETHER
THE STUDY IS REASONABLY SAFE TO
PROCEED OR IF IT'S NOT, WE WILL
PUT IT ON WHAT'S KNOWN AS
CLINICAL HOLD MEANING YOU WILL
NOT BE ABLE TO LEGALLY CONDUCT
THAT STUDY IN THE UNITED STATES.
SOME DIVISIONS MAY ISSUE WHAT'S
KNOWN AS A SAFE TO PROCEED
LETTER BUT EVEN WITHOUT THAT
LETTER, IF YOU DO NOT HEAR THAT
YOU'RE ON CLINICAL HOLD WITHIN
THIRTY DAYS YOU CAN LEGALLY
START CONDUCT OF THE STUDY. ONE
THING I WOULD LIKE TO STRESS, WE
DON'T APPROVE INDS. WE ALLOW
THEM TO PROCEED. BUT THAT'S NOT
THE SAME STANDARD AS DETERMINING
AN APPROVAL. THAT COMES MUCH
LATER ON IN THE NEW DRUG
APPLICATION PHASE. COMPLEX
PRODUCTS DON'T GIVE US EXTRA
TIME. IN OTHER WORDS, WE HAVE
30 DAYS, WE ONLY HAVE 30 DAYS,
YOU DON'T HEAR FROM US, YOU CAN
PROCEED. NOW, THERE ARE
OCCASIONS WHERE WE WILL REACH
OUT TO A SPONSOR AND SAY, YOU
KNOW, WE'RE GOING TO NEED SOME
MORE TIME. WE WOULD VERY MUCH
APPRECIATE IT IF YOU WOULD AGREE
NOT TO START THE STUDY UNTIL YOU
HEAR FROM US. I WILL SAY THAT
EVEN IF YOUR STUDY IS NOT ON
CLINICAL HOLD WE WILL VERY OFTEN
HAVE SOME ADVICE TO GIVE IN
TERMS OF WAYS THAT WE THINK YOU
MAY IMPROVE THE STUDY TO REACH
YOUR OBJECTIVES MORE
EFFICIENTLY. NEXT SLIDE,
PLEASE. ONCE YOU PASS 30 DAYS,
AND YOUR STUDY IS UNDERWAY YOU
CAN AMEND THAT APPLICATION WHEN
THINGS CHANGE. THE TYPES OF
AMENDMENTS INCLUDE BOTH PROTOCOL
AMENDMENTS AND INFORMATION
AMENDMENTS AND WE'LL TALK A
LITTLE BIT MORE ABOUT THE TYPES
OF THINGS THAT THAT MIGHT
ENTAIL. NEXT SLIDE. SO A
PROTOCOL AMENDMENT INCLUDES
THINGS LIKE A NEW PROTOCOL. IF
THERE IS A CHANGE IN YOUR
EXISTING PROTOCOL THAT WOULD BE
A PROTOCOL AMENDMENT AND ANYTIME
YOU ADD A NEW INVESTIGATOR TO A
PROTOCOL, YOU WANT TO SEND AN
AMENDMENT TO SHARE THAT
INFORMATION WITH US. NEXT
SLIDE. INFORMATION AMENDMENTS.
IF IT'S NOT A PROTOCOL AMENDMENT
BY BUT STILL SOMETHING YOU WANT
TO TELL US YOU CAN SEND AN
INFORMATION AMENDMENT.
THIS CAN INCLUDE NEW INFORMATION
MAYBE EVEN FROM FOREIGN STUDIES.
CLINICAL. CLINICAL
PHARMACOLOGY. SOME NON-CLINICAL
INFORMATION. NEW CHEMISTRY
INFORMATION. AND STUDY REPORTS.
YOU ARE ALSO OBLIGATED TO LET US
KNOW IF YOU DISCOUNT --
DISCONTINUE A STUDY WITHIN FIVE
DAYS OF DOING SO.
OTHER AMENDMENTS INCLUDE IF
YOU'RE THE SPONSOR AND YOU WANT
TO TRANSFER THAT IND TO ANOTHER
ENTITY, YOU HAVE TO TELL US
ABOUT THAT. AND THAT NEW ENTITY
ALSO HAS TO ACCEPT THAT
ASSIGNMENT OR TRANSFER AND THEN
FINALLY IF YOU MOVE YOU GOT TO
LET US KNOW AND YOU'LL HAVE TO
SEND IN A CHANGE OF ADDRESS FOR
THAT. NEXT SLIDE, PLEASE. AND
FINALLY THERE ARE SOME IND
REPORTING REQUIREMENTS. SAFETY
REPORTS AND ANNUAL REPORTS.
NEXT SLIDE. AND IN TERMS OF
OTHER ACTIVITIES, IF YOU ARE NOT
CONDUCTING STUDIES CURRENTLY OR
PERHAPS YOU NEVER STARTED THE
STUDY THAT YOU HAD SENT THE
PROTOCOL FOR, YOU CAN CHOOSE TO
HAVE THAT IND INACTIVATED AND
THE BENEFIT OF THAT IS THEN YOU
WOULD NOT BE REQUIRED TO SUBMIT
AN ANNUAL REPORT. IF YOU WERE
TO RESUME ACTIVITIES UNDER THAT
IND YOU WOULD SEND IN A REQUEST
FOR REACTIVATION. ONCE YOU DO
THAT, THE 30 DAY CLOCK STARTS
AGAIN. SO YOU CAN'T START
ANYTHING UNTIL YOU HEAR -- UNTIL
30 DAYS ARE PASSED. IF YOU ARE
DONE WITH YOUR STUDIES UNDER THE
IND AND YOU HAVE NO INTENTION OF
DOING ANYMORE, YOU CAN REQUEST
THAT THE IND BE WITHDRAWN. AND
FINALLY, IF WE DETERMINE THAT
YOU ARE NOT COMPLIANT WITH THE
IND REGULATIONS WE CAN TERMINATE
YOUR IND MEANING YOU WOULD NOT
BE ALLOWED TO CONTINUE ANY
PROTOCOLS UNDER THAT IND. NEXT
SLIDE. SO THERE'S A LOT OF
INFORMATION THAT WE PUT OUT
ABOUT PROCESSES AND I HAVE TRIED
TO JUST CAPTURE SOME OF THE MOST
HELPFUL. AND SO THERE ARE SOME
LINKS EMBEDDED HERE. NEXT
SLIDE. SOME OTHER RESOURCES
THAT YOU MIGHT FIND HELPFUL IF
YOU WANT TO LEARN MORE ABOUT
ELECTRONIC SUBMISSIONS YOU CAN
SEND AN E-MAIL TO THAT ADDRESS
THERE. AND THEN YOU ALSO IF YOU
WANT TO CORRESPOND BY E-MAIL
WITH THE FDA YOU WILL NEED TO
SET UP SECURE E-MAIL TO DO THAT.
ANYTHING THAT REQUIRES A
REGULATORY OPINION, ADVICE OR
CERTAINLY ANY KIND OF ACTION ON
OUR PART THAT IS NOT ACCEPTABLE
FOR E-MAIL. SO THIS WOULD BE
FOR THINGS LIKE IF WE ARE -- IF
WE GRANTED YOU A MEETING AND NOW
WE'RE GOING TO TALK ABOUT WHEN
THAT MEETING COULD BE. SOME
LOGISTICAL TYPES OF THINGS LIKE
THAT BUT ANYTHING THAT REQUIRES
US TO MAKE A DECISION SHOULD BE
FORMALLY SUBMITTED. AND NEXT
SLIDE, SO ALL OF THAT
INFORMATION VERY QUICK, IF YOU
HAVE SPECIFIC QUESTIONS OR
ANYTHING WAS NOT CLEAR, I HAVE
INCLUDE MY DIRECT WORK PHONE
NUMBER AND MY E-MAIL ADDRESS.
DON'T E-MAIL ME IF YOU DON'T
HAVE SECURE E-MAIL THOUGH. AND
I AM HAPPY TO HELP IF IT'S A
QUESTION I CAN'T ANSWER MYSELF I
WILL CERTAINLY PUT YOU IN
CONSTITUENT WITH THE -- TOUCH
WITH THE PEOPLE WHO CAN.
I REALLY APPRECIATE YOUR
ATTENTION. AND LOOK FORWARD TO
ANY QUESTIONS OR COMMENTS YOU
MAY HAVE. THANK YOU.
>> THANK YOU SO MUCH. AND WE
HAVE OUR LAST SPEAKER. DR. ERIC
HOW DABUD
HUDAK. DR. HIGH DABBING, THE
FLOOR IS YOURS.
>> THANK YOU, HELENA AND GOOD
AFTERNOON, EVERYONE. TODAY I
WILL BE TAKING YOU THROUGH THE
GRANT PROGRAMS AND RESOURCES WE
HAVE AVAILABLE THROUGH THE
INITIATIVE, THE SUPPORT RESEARCH
FUND. SO THE NIH HEAL
INITIATIVE TOR HELPING TO END
ADDICTION LONG-TERM INITIATIVE
IS AN NIH-WIDE EFFORT TO SPEED
SCIENTIFIC SOLUTION TO STEM THE
NATIONAL OPIOID PUBLIC HEALTH
CRISIS. TO DO THIS WE'VE
LAUNCHED A COORDINATED SET OF
PROGRAM TO BETTER UNDERSTAND,
MANAGE AND TREAT PAIN AND TO
IMPROVE PREVENTION AND TREATMENT
STRATEGIES FOR OPIOID MISUSE AND
DISORDER. HEAL IS CO-LED BY THE
DIRECTORS BY THE DIRECTORS ON
THE INSTITUTE OF DRUG ABUSE,
DR. NORA AND DR. TALT WALT
EVERY. WE HAVE INITIATIVES IN
ALL 50 STATES.
HEAL IS A COLLABORATION ACROSS
INSTITUTES AND CENTERS AND
THROUGH OUR RESEARCH WE HAVE
GAINED OVER 40 FDA APPROVALS FOR
INVESTIGATIONAL NEW DRUGS OR
DEVICES AND CURRENTLY OVER 300
CLINICAL TRIALS ARE UNDERWEI WE
ALSO HAVE ONGOING PARTNERSHIPS
WITH COMMUNITIES, FEDERAL, STATE
AND LOCAL AGENCIES, AND PRIVATE
SECTOR, COMPANIES AND ACADEMIA.
WE WANT TO PROVIDE SAFE PAIN
TREATMENT TO IMPROVE QUALITY OF
LIFE FOR ALL PEOPLE. THROUGH
THESE RESEARCH EFFORTS WE WANT
TO UNDERSTAND THE BIOLOGICAL
UNDERPINNINGS OF CHRONIC PAIN,
UNDERSTAND THE DISCOVERY OF PAIN
TREATMENTS. ADVANCE NEW
NONADDICTIVE PAIN TREATMENTS
THROUGH THE CLINICAL PIPELINE,
INFORM BEST PRACTICES FOR
EFFECTIVE PAIN MANAGEMENT WHILE
MINIMIZING THE RISK OF
ADDICTION. SINCE 2018 WHEN HEAL
WAS LAUNCHED WE HAVE INVESTED
OVER 1.25 BILLION DOLLARS ON
PAIN AND CROSSCUTTING RESEARCH.
THIS SLIDESHOWS A SNAPSHOT OF
ALL THE DIFFERENT HEAL PROGRAMS
WITH FUNDING TO SUPPORT PAIN
RESEARCH. AS YOU CAN SEE OUR
PROGRAMS COVER THE ENTIRE
PIPELINE FROM DISCOVERY RESEARCH
THROUGH CLINICAL TRIALS AND
IMPLEMENTATION SCIENCE. WE
SUPPORT MANY RESEARCH FOCUS
AREAS AS WELL SUCH AS DIAGNOSTIC
TECHNOLOGIES, PHARMACEUTICALS
INCLUDING SMALL MOLECULES AND
BIOLOG
BIOLOGICS, AND TREAT PAIN. SO I
WILL NOW FOCUS ON THE DEVICES
PROGRAM. IN THIS PROGRAM OUR
GOAL IS TO SUPPORT NEXT
GENERATION TECHNOLOGIES TO
DIAGNOSE AND TREAT PAIN BY
SUPPORTING THE DEVELOPMENT,
TRANSLATION AND OPTIMIZATION OF
SAFE DEVICES. OUR PROGRAMS SPAN
THE RESEARCH SPACE FROM DEVICE
DEVELOPMENT THROUGH DEVICE
OPTIMIZATION AND CLINICAL TRIALS
AND THIS IS A FOCUS AREA FOR
HEAL BECAUSE WE BELIEVE DEVICES
REPRESENT FARM SITE --
PHARMACEUTICAL APPROACHES WITH
LITTLE TO KNOW ADDICTION
LIABILITY.
SO WITHIN THIS PROGRAM THE FIRST
FUNDING OPPORTUNITY I WANT TO
HIGHLIGHT, WE SUPPORT
PRECLINICAL TECHNOLOGY
DEVELOPMENT, THIS R 18 PROGRAM
OFFERS THREE YEAR GRANTS TO
SUPPORT THE DEVELOPMENT OF
CLINICAL GRADE PROTOTYPE DEVICE
FOR THE DIAGNOSIS AND TREATMENT
OF PAIN IN OPIOID USE DISORDER
AND THROUGH THIS FUNDING WE WANT
TO FACILITATE THE DEVELOPMENT OF
NEW DEVICES UP TO THE STATE OF
READINESS FOR HUMAN TESTING
THESE ARE NOT HYPOTHESIS DRIVEN
AND CAN FOCUS ON EARLY TO MID
STAGE ENGINEERING DEVELOPMENT,
PRECLINICAL ACTIVITIES THROUGH
MODELING STUDIES AS WELL AS
PROOF OF CONCEPT TESTING IN
ANIMALS. THIS PROGRAM IS LED BY
MY COLLEAGUE DR. MARIA SO FEEL
FREE TO REACH OUT WITH QUESTIONS
ABOUT THIS PROGRAM. THE NEXT
STAGE OF OUR PROGRAM SUPPORTS
THE TRANSLATION OF YOUR
TECHNOLOGY TO CLINICAL USE WE DO
THIS THROUGH A PARTNERSHIP WITH
NIH BLUEPRINT MED TECH PROGRAM.
BLUEPRINT MED TECH ACCELERATES
THE DEVELOPMENT OF CUTTING EDGE
MEDICAL DEVICES.
THE HEAL INITIATIVE IS
PARTICIPATING IN THIS PROGRAM
AND IS SEEKING TECHNOLOGIES FOR
PAIN AND OPIOID USE DISORDER
THROUGH THESE GRANTS WE EXPECT
YOU TO COMPLETE THE VALIDATION
OF YOUR MEDICAL DEVICE, PERFORM
IDE ENABLING STUDIES AND SEEK
IRB APPROVAL TO INITIATE AN
EARLY STAGE CLINICAL TRIAL ON
YOUR TECHNOLOGY. THIS PAGE
ILLUSTRATES THE TWO PHASES OF
THE PROGRAM. THE EARLIER STAGE
DEVELOPMENT PORTION OF THE
PROGRAM SUPPORTS PRECLINICAL
PROJECTS TO OPTIMIZE YOUR
TECHNOLOGY AND ITS
COMMERCIALIZATION POTENTIAL.
THIS PART OF THE PROGRAM IS PART
OF THE UP CUE BAY TOR HUBS.
YOU CAN FIND OUT MORE ABOUT THIS
PROGRAM AND THE APPLICATION
PROCESS BY GOING TO BLUEPRINT
NEUROTECH.ORG.
THE LATER TRANSLATIONAL PHASE OF
THE PROGRAM SUPPORTS THE WORK
AND APPROVALS TO CONDUCT AN
EARLY STAGE CLINICAL TRIAL WITH
YOUR DEVICE INTERVENTION TO
DEMONSTRATE SAFETY AND BEGIN
EXAMINING THE EFFICACY. THESE
PROJECTS ARE SUPPORTED THROUGH
TRADITIONAL AGREEMENT AWARDS,
ANOTHER VERSION SPECIFICALLY FOR
SMALL BUSINESSES. IF YOU
RECEIVE AN AWARD THROUGH THE
BLUEPRINT MED TECH PROGRAM YOU
CAN GAIN ACCESS TO ADDITIONAL
THREE RESOURCES THAT NEED IN THE
TRANSLATION AND
COMMERCIALIZATION OF YOUR
TECHNOLOGY. THESE INCLUDE
SERVICES SUCH AS DESIGN,
PROTOTYPING AND BENCH TESTING,
CONSULTANTS FOR BUSINESS
DEVELOPMENT. REGULATORY
COMPLIANCE AND QUALITY SYSTEM
DEVELOPMENT. AS WELL AS BY OWE
CO
BIO COMPATIBILITY. OUR RESEARCH
PROGRAM OFFERS FIVE YEAR GRANTS
TO SUPPORT INTERDISCIPLINARY
RESEARCH TO INVESTIGATE THE
MECHANISMS UNDERLYING WITH
MEDICAL DEVICES THE OVERALL GOAL
HERE IS OPTIMIZATION OF
THERAPEUTIC OUTCOMES FOR
PATIENTS IN PAIN. THE
MOTIVATION IS THAT ALTHOUGH
THERE ARE MANY DEVICES ON THE
MARKET FOR TREETH TREATING PAIN
MANY LACK THE RATIONALE FOR HOW
THEY WORK. BY DEVELOPING A
BETTER UNDERSTANDING OF
MECHANISMS WE AIM TO OPTIMIZE
THESE THERAPIES TO IMPROVE THEIR
EFFICACY. THESE ARE TEAM
SCIENCE GRANTS THAT ALLOW
RESEARCH IN THE PRECLINICAL OR
CLINICAL SPACE AND YOU CAN USE A
COMBINATION OF TECHNIQUES SUCH
AS ANIMAL STUD DI-DEE DID-- STD
HOW THAT INFORMATION CAN BE USED
TO IMPROVE CARE IN THE CLINIC.
I ALSO WANT TO HIGHLIGHT THAT
HEAL HAS ITS FUNDING
OPPORTUNITIES FOR PAIN
MANAGEMENT. THESE ARE PHASE ONE
AND PHASE TWO SVIR AND STTR
AWARDS THAT SUPPORT SMALL
BUSINESSES FOR PAIN MANAGEMENT.
WE HAVE A DUE DATE FOR THIS
PROGRAM COMING UP IN SEPTEMBER
AND YOU CAN REACH OUT TO MY
COLLEAGUE DR. EMILY FOR MORE
INFORMATION. ONE FINAL RESOURCE
I WANT TO HIGHLIGHT IS THE HEAL
INITIATIVE PURPOSE NETWORK. YOU
CAN THINK OF THIS A SOCIAL
NETWORK MORE PAIN RESEARCHERS
WHERE YOU CAN CONNECT WITH
COLLEAGUES, ACCESS INFORMATION
ABOUT PAIN FUNDING.
ACCESS INFORMATION ABOUT
NETWORKING OPPORTUNITIES, AND
OTHER UPCOMING PAIN CONFERENCES
AND EVENTS. THIS IS OPEN TO
ANYONE IN THE RESEARCH SPACE SO
YOU DO NOT NEED TO HAVE HEAL
FUNDING TO BE PART OF THIS
NETWORK SO WE ENCOURAGE YOU TO
JOIN THE NETWORK BY GOING TO
PAIN RESEARCHERS.COM AND SIGNING
UP. WITH THAT I'D LIKE TO
RECOGNIZE THE NINDS
TRANSLATIONAL NEURAL DEVICES
TEAM. AND THE PROGRAMS TO
SUPPORT DEVELOPMENT AND
TRANSLATION OF MEDICAL DEVICES.
AND THE BIOLOGICAL DISORDERS.
PLEASE REACH OUT TO US AND THANK
YOU FOR YOUR TIME.
>> THANK YOU SO MUCH DR. HIGH
HUDAK. WE WILL GO ON TO THE
DISCUSSION CENTER.
DR. GOLDSTEIN. DR. GOLDSTEIN IS
GOING TO MODERATE THE DISCUSSION
SECTION AND WE WILL EXTEND OUR
MEETING UNTIL 5:15. OKAY.
DR. GOLDSTEIN TAKE IT AWAY. ANY
DUE TO A LIMITED AMOUNT OF TIME
I WANTED TO POSE A COUPLE OF
QUESTIONS TO OUR PANELISTS AND
SEE IF THEY CAN SHED SOME LIGHT
ON SOME IMPORTANT QUESTIONS THAT
WE'VE COME UP WITH OVER THE LAST
SEVERAL DAYS. THE FIRST ONE I
SORT OF WOULD LIKE ANY PANELIST
TO JOIN IN AND ANSWER IS THAT
WHY DO YOU FEEL THERE ARE
RELATIVELY FEW RESEARCH
PROPOSALS FOR GYNECOLOGICAL PAIN
DISORDERS? BASICALLY, WHAT ARE
THE GAPS EITHER CONCEPTUAL,
PRACTICAL OR TECHNICAL AND
CHALLENGES THAT YOU'RE FACING
THAT MAY IMPEDE YOUR WANTING TO
DO OR ABILITY TO HAVE
GYNECOLOGICAL PAIN RESOURCE.
ANY OF THE PANELISTS HAVE ANY
OPINIONS ON THAT QUESTION?
>> HI. WELL I CAN SPEAK TO JUST
ONE ASPECT THAT I THINK HAS
IMPEDED SOME RESEARCH. I -- MY
RESEARCH FOCUSES A LOT ON THE
MAN -- MENSTRUAL CYCLE.
JUST ASSESSING THE MENSTRUAL
CYCLE IS VERY CHALLENGING IN A
RESEARCH CONTEXT.
IT REQUIRES A LOT OF RESOURCES,
A LOT OF FEEDBACK FROM
PARTICIPANTS AND TO ACCURATELY
PHASE THE MENSTRUAL CYCLE WHICH
I THINK IS A REALLY IMPORTANT
PART OF GYNECOLOGICAL PAIN
RESEARCH IT'S A LOT MORE THAN I
THINK WHAT MOST PEOPLE WANT TO
GET INVOLVED IN. THAT BEING
SAID IT'S ABSOLUTELY IMPORTANT
AND IT'S ABSOLUTELY CRITICAL TO
BETTER UNDERSTANDING WOMEN'S
GYNECOLOGICAL PAIN AND ALSO
TREATMENT AND APPROPRIATE CARE.
>> COMPLETELY AGREE. DO YOU
FIND THAT IT'S DIFFICULT TO GET
PARTICIPANTS TO PARTICIPATE IN
CLINICAL TRIALS OR THEY'RE MORE
THAN HAPPY TO FIND THAT IT'S
DIFFICULT TO GET APPROVAL OR
WHAT BARRIERS HAVE YOU RUN INTO
IF ANY?
>> FOR MY RESEARCH WHICH IS
FOCUSED PRIMARILY ON ADOLESCENTS
AND YOUNG ADULTS I DON'T KNOW IN
COMPARISON TO THE ADULT
POPULATION BUT MANY OF THESE
YOUNG INDIVIDUALS ARE ALREADY
TRACKING THEIR MAN STRUL PSY
MENSTRUAL CYCLE SO THAT'S A GOOD
BENEFIT.
WE DEVELOP CLOSE RELATIONSHIPS
WITH THESE PARTICIPANTS, WE'RE
IN CONTACT WITH THEM FREQUENTLY
AND THAT HELPS WITH THE TRACKING
AND THE, YOU KNOW, USING VARIOUS
MEASURES TO ASSESS OVULATION AND
THOSE IMPORTANT ASPECTS AND SO
IT'S A REAL COMMITMENT TO THAT
PART OF THE RESEARCH. THAT I
THINK IS NOT CONSIDERED AS MUCH
IN SOME OTHER AREAS THAT ARE,
YOU KNOW, LESS KIND OF DIRECTLY
FOCUSED ON THE MENSTRUAL CYCLE.
>> HOW ABOUT SOME OF OUR OTHER
PANELISTS? WHAT BARRIERS THAT
YOU MAY HAVE FACED OR MAYBE SOME
SOLUTIONS TO -- YOU'VE BEEN ABLE
TO OVERCOME SOME OF THESE
BARRIERS? HAS ANYONE HAD
DIFFICULTY GETTING PEOPLE TO
PARTICIPATE IN CLINICAL TRIALS
MAYBE BECAUSE OF STIGMA OR ANY
OTHER REASONS? THAT THEY'VE NOT
BEEN ABLE TO GET PEOPLE OR THEY
REALLY -- THAT CAME OUT OF A
DIFFICULT PROBLEM? MAYBE I'M
NOT ASKING THE RIGHT QUESTIONS.
MAYBE, OKAY, I'LL JUMP ONTO THE
NEXT POSSIBLE QUESTION, WE HEARD
A LOT OF REALLY AMAZING THINGS
TODAY. AND NOT TOOTING OUR OWN
HORN IF POSSIBLE. WHAT ARE THE
THINGS YOU'RE MOST EXCITED ABOUT
THAT YOU MAY HAVE HEARD TODAY
AND MAYBE SOME THINGS THAT WE
HAVEN'T TALKED ABOUT TODAY THAT
YOU'RE REALLY EXCITED ABOUT
MOVING FORWARD. IN
GYNECOLOGICAL PAIN RESEARCH.
>> I CAN TRY FIRST. I THINK
PART OF THE THINGS THAT I WAS
EXCITED ABOUT WAS FIRST OF ALL
SEEING ALL THESE AMAZING
SCIENTISTS DOING RESEARCH IN
THIS AREA, SECOND IS THE NEW
PIPELINE OF DRUGS THAT ARE
COMING IN TO REPLACE THE LONG
USED GENERICS THAT HAVE BEEN
USED FOR A LONG TIME OFF LABEL.
SO HOPEFULLY THERE'LL BE
PRODUCTS THAT WILL BE APPROVED.
IT WILL HELP APPROVE PRODUCTS
FOR SPECIFIC INDICATIONS AND NOT
JUST HAVE OFF LABEL PRESCRIBED
PRODUCTS. THAT IS CHALLENGING.
BECAUSE OF REGULATORY. BECAUSE
THERE IS NOT APPROVED PRODUCTS
IT'S NOT EASY TO GO A 505B 2
ROIT SO THAT EXTENDS THE
REGULATORY PATH TO HAVE THE
FIRST PRODUCT APPROVED.
THAT BEING SAID IF IT WERE EASY
EVERYBODY WOULD DO AND IT
HOPEFULLY THE FIRST PRODUCT WILL
OPEN THE DOOR TO MORE AND MORE
AND MORE TO BE MORE OPTIONS FOR
INDICATIONS LIKE THESE THAT ARE
SUCH A NEED. SO VERY NICE TO
SEE EVERYBODY.
>> I WOULD LIKE TO SAY I WISH WE
HAVE THE PROBLEM WITH THE
CLINICAL TRIALS BECAUSE WE'RE
JUST GETTING AT ANIMALS BUT
WE'RE LOOKING TO SEE WHAT WE CAN
DO TO MANAGE THE SITUATIONS WITH
NONPHARMACOLOGICAL MEANS TO
BETTER UNDERSTAND HOW IT AFFECTS
THE CENTRAL NERVOUS SYSTEM SO
WE'RE LOOKING FORWARD TO SEEING
THE RESULTS WE GET FROM OUR
ANIMAL TRIALS AND AS QUICKLY AS
POSSIBLE TO PULL TOGETHER THAT
RELIGION STUDY I DON'T
ANTICIPATE HAVING DIFFICULTY
FINDING THE PEOPLE FOR THIS
CLINICAL STUDY SINCE WHAT WE'RE
DOING IS FAIRLY NON RISK. IT'S
LOW IMPACT. AND TREMENDOUS
NUMBER OF PEOPLE THAT EXIST THAT
ARE CLAMBERING FOR A SOLUTION.
SO IT'S JUST TIME FOR US, THAT'S
BIGGEST CHALLENGE.
>> FOR THE PEOPLE DOING RESEARCH
IN ENDOMETRIOSIS, HAVE YOU FOUND
MANY WILLING PARTICIPANTS OR ANY
BARRIERS TO YOUR -- ANY
PARTICIPATION IN YOUR CLINICAL
TRIALS OR AGAIN ANY BARRIERS
THAT YOU MIGHT HAVE FIND OR ANY
SOLUTIONS TO SOME OF THOSE
BARRIE
BARRIERS?
>> CAN I SPEAK THE TRIAL THAT
WE'RE DOING RIGHT NOW IT'S
FAIRLY BENIGN. IT'S
PARTICIPANTS CAN GENERALLY JUST
KIND OF FILL OUT QUESTIONNAIRES
ON THEIR OWN. SO IT'S NOT A
VERY BURDENSOME TYPE OF STUDY
BUT WHAT WE DO FIND IS THAT, SO
MANY WOMEN OUT THERE ARE HIGHLY
INVESTED IN PARTICIPATING, AT
LEAST IN THIS PARTICULAR
RESEARCH. I THINK THE ONLY
BARRIER IS JUST THE TIME
COMMITMENT OBVIOUSLY, PEOPLE
HAVE VERY BUSY LIVES BUT, YOU
KNOW, YOU FIND A LOT OF WOMEN
ARE REALLY WILLING TO DO
ANYTHING THAT THEY NEED TO DO IN
ORDER TO HELP PROGRESS TREATMENT
AND FIND WAYS OF BEING ABLE TO
KIND OF DEAL WITH SOME OF THE
SYMPTOMS THAT THEY'RE HAVING.
SO WE HAVEN'T NECESSARILY
ENCOUNTERED A LOT OF ISSUES.
NOW I WILL SPEAK TO DR. PAYNE'S
WORK. I USED TO DO RESEARCH
BACK IN THE DAY AND I CAN ATTEST
TO HOW BURDENSOME THAT ACTUALLY
IS. IT'S VERY TIME-CONSUMING
BUT YOU HAVE TO CAPTURE PEOPLE
AT CERTAIN TIME POINTS AND
YOU'RE ASKING WOMEN TO DO A LOT
OF WORK REPORTING ON THEIR
MENSTRUAL CYCLE AND WHATEVER
ELSE IS INVOLVED BUT THESE ARE
THE KIND OF STUDIES THAT WE NEED
TO BE DOING AND I ALWAYS THINK
THAT SOMETIMES FOR PEOPLE THE
BURDEN CAN BECOME TOO MUCH
ESPECIALLY IF THEY HAVE VERY
BUSY LIVES BUT, YOU KNOW, IT'S
JUST KIND OF PART OF DOING THAT
TYPE OF RESEARCH. SO, YES, I
VERY MUCH UNDERSTAND SOME OF
THAT BACKGROUND. HOW RIGOROUS
THOSE PROTOCOLS CAN ACTUALLY BE.
>> I WILL SAY THAT I THINK WE'VE
MADE SOME PROGRESS IN THIS AREA
IN TERMS OF USE OF DIGITAL
HEALTH TECHNOLOGIES. AS OPPOSED
TO VERY NOT THAT LONG AGO BUT
BACK IN THE DAY IT WAS ALL BY
HAND AND DIARIES. AND THE
AMOUNT OF MISSING DATA REALLY
CALLED INTO QUESTION SOME OF THE
RESULTS WE WERE SEEING. SO I
WILL JUST TOSS OUT THAT BIT OF
HOPE THAT THINGS ARE GETTING
BETTER.
>> I WANT TO ADD ONE MORE TOPIC.
10% OF ALL THE PRODUCTIVE WOMAN,
BUT OUR ASSOCIATES ARE VERY
LIMITED AND IT'S VERY
HETEROGENOUS OF WHEN WE TRY TO
TRANSLATIONAL STUDY I THINK
COMPARED TO THE OTHER. I THINK
THAT OUR RESOURCES ARE VERY
LIMITED TO DO THAT KIND OF
TRANSLATIONAL STUDY AND THE
METHOD IS ALSO VERY LIMITED. I
TRIED TO STUDY IN THE CLINICAL
ANIMAL. THERE IS NO METHOD. SO
WE NEED TO MORE BASIC KIND OF --
MORE COMPARED TO THE OTHER TO
DEVELOP THAT KIND OF A BASIC
RESOUR
RESOURCE.
>> I MAY SWITCH TO A DIFFERENT
TOPIC NOW. BECAUSE IT'S SUCH A
BIG PROBLEM IN SOCIETY TODAY
WHICH IS OUR OPIATE CRISIS WHAT
THERE SOLUTION AND STRATEGIES
THAT YOU UTILIZE TO PREVENT
OPIATE MISUSE AND ADDICTION
RELATE TO DO GYNECOLOGIC PAIN
GIVEN THAT THESE CAN BE CHRONIC
PAIN SYNDROMES, SOMETIMES
WITHOUT ANY SOLUTION.
>> IT'S PRETTY OBVIOUS. THERMAL
MODULATION. THANKS FOR ASKING.
>> ANY OTHER SUGGESTIONS TO
PREVENT THE USE OF OPIATES AND
THE PREVENTION OF ADDICTION. OR
HAVE YOU NOT SEEN THAT MUCH OF A
PROBLEM IN THIS PATIENT
POPULATION? OKAY.
CONSIDERING --
>> IF IT'S OKAY -- DR. GOLDSTEIN
IF IT'S OKAY I WOULD LIKE TO
ANSWER THE QUESTION ABOUT
CLINICAL TRIALS FROM THE PATIENT
PERSPECTIVE. SO I JUST -- I
THINK THERE'S TWO DIFFERENT
THINGS THAT I'M SEEING IN TERMS
OF PATIENTS AND FIRST OF ALL I
REALLY AGREE WITH WHAT
DR. PAYNE -- OR SORRY
DR. BARTLEY ONE OR BOTH OF YOU
WERE SAYING ABOUT HOW PATIENTS
ARE VERY INVESTED IN WANTING TO
SOLVE THESE PROBLEMS AND WANT TO
VOLUNTEER AND HELP IF THEY HEAR
ABOUT AN OPPORTUNITY. I THINK
THERE'S TWO MAIN ISSUES THAT I
FIND IN TERMS OF THE
CONVERSATIONS I'M HAVING WITH
PATIENTS. ONE IS THAT SO MANY
PATIENTS ARE NOT DIAGNOSED IF
YOU DON'T HAVE A DIAGNOSIS YOU
DON'T NECESSARILY HAVE ANYWHERE
TO GO THAT YOU WOULD SEE ABOUT
AN -- YOU WOULD HEAR ABOUT AN
OPPORTUNITY TO PARTICIPATE IN A
CLINICAL TRIAL AND MANY PATIENTS
HAVE NORMALIZED THEIR SYMPTOMS
OR THINK THEIR PAIN, THEIR
URINARY SYMPTOMS ARE NORMAL AND
THEIR PAIN IS NORMAL AND THEY
DON'T ACTUALLY THINK OF
THEMSELVES AS HAVING A MEDICAL
CONDITION UNTIL THEY FIND A
PROVIDER THAT ASKS ABOUT THEIR
MEDICAL CONDITION UNTIL THEIR
PAIN GET TO A POINT THAT IS
COMPLETELY UNTENABLE IF YOU
DON'T THINK YOU HAVE A MEDICAL
CONDITION YOUR SH -- YOU'RE NOT
NECESSARILY LOOKING FOR THE
RIGHT OPPORTUNITIES TO
PARTICIPATE IN TRIALS. I THINK
THAT'S ONE CATEGORY OF PATIENTS
THAT DON'T KNOW WHAT THEY HAVE.
THEY'RE EITHER MISDIAGNOSED OR
NOT DIAGNOSISED.
ON THE OTHER CATEGORY OF
PATIENTS THAT ARE ON THE
OPPOSITE END WHERE THEY'RE
TRYING LITERALLY EVERYTHING
UNDER THE SUN AND THEY ARE
SPENDING HOURS AND HOURS EVERY
WEEK GOING FOR PHYSICAL THERAPY,
TRYING SOME NEW TREATMENT,
TRACKING THEIR SYMPTOMS,
TRACKING THEIR TREATMENTS AND I
THINK THOSE PATIENTS ARE KIND OF
THERE THE OPPOSITE SITUATION
WHERE IT'S A LITTLE BIT HARD TO
FIT WITH -- THEY'RE ALREADY
TRYING SO MANY THINGS THAT IT'S
HARD TO SAY WHY SHOULD I DO THIS
ADDITIONAL THING ON TOP OF
EVERYTHING ELSE THAT I'M TRYING
AND TO UNDERSTAND THAT THIS
MIGHT BE WORTHWHILE AND THAT
MIGHT BE A DIFFERENT EXPERIENCE
FROM SOMETHING THEY'VE TRIED IN
THE PAST. I THINK THOSE ARE TWO
ISSUES I DEFINITELY THINK THE
FIRST ONE IS A BIGGER ISSUE THAT
A MAJORITY OF THE PATIENTS ARE
MISDIAGNOSED AND WOULDN'T KNOW
WHEN THERE'S AN OPPORTUNITY TO
PARTICIPATE IN RESEARCH.
>> I WANT TO ADD ONTO THAT
BECAUSE THAT IS EXCELLENT POINTS
THAT YOU BROUGHT UP. WE
ACTUALLY SEE A LOT OF WOMEN COME
IN THROUGH THE CLINICS WHO HAD
NEVER EVEN HEARD ABOUT
ENDOMETRIOSIS BEFORE AND I THINK
THAT'S A REALLY BIG PROBLEM IS
THAT THERE'S STILL A LACK OF
AWARENESS. ABOUT THESE TYPES OF
CONDITIONS. INCLUDING
ENDOMETRIOSIS I CAN THINK BACK,
YOU KNOW, FIVE YEARS AGO. YOU
JUST REALLY DON'T HEAR ABOUT
THESE THINGS NOW YOU HEAR ABOUT
ENDOMETRIOSIS, ON COMMERCIALS,
AND SO I THINK THAT HAS BEEN
INCREASED AWARENESS BY WE STILL
HAVE A LOT OF ROOM TO GROW AND I
THINK IT'S JUST GOING TO REQUIRE
THAT WE KEEP TALKING ABOUT THESE
THINGS. WE KEEP DOING RESEARCH.
WE HELP -- WE WORK ON THIS FROM
A POLICY PERSPECTIVE AND REALLY
JUST TO TRY CREATE AWARENESS AND
KNOWLEDGE ABOUT THESE CONDITIONS
SO THAT OUR PATIENTS ARE AWARE
OF THEM. OUR MEDICAL PROVIDERS,
OUR RESEARCHERS ARE WARE AWARE
OF THEM SO WOMEN CAN BE HEARD.
ULTIMATELY WE NEED TO KEEP THE
CONVERSATION GOING. SO WE CAN
GAIN MORE MOMENTUM IN THE FIELD.
>> I THINK I WAS INCREDIBLY
MOVED BY KEENA'S DISCUSSION
TODAY ABOUT NOT JUST THE
EMOTIONAL COST AND THE PHYSICAL
COST OF CHRONIC PAIN BUT THE
ECONOMIC COSTS THAT THE DECISION
SHE HAS TO MAKE TO TRY TO GET
CARE TO SIGN ON CARE AND SINCE
THERE ARE NO APPROVED TREATMENTS
THAT MANY THIRD PARTY PROVIDERS
WILL NOT REIMBURSE OR PAY FOR
THESE TREATMENTS. ANY STRATEGY
THAT YOU HAVE FOUND AS PROVIDERS
WHO ARE TREATING PAIN DISORDERS
THAT MAY NOT HAVE ANY FDA
APPROVED TREATMENTS TO HELP
PATIENTS GET THE CARE, SOMEWHAT
AFFORDABLY GIVEN THE DIFFICULTY
SOMETIMES WITH THIRD PARTY
PAYERS? NO ANSWERS TO THAT.
ANY OTHER QUESTIONS THAT PEOPLE
WANT TO THROW OUT TO THE
CO-PANELISTS THAT MAYBE I
HAVEN'T ADDRESSED OR OUR
PARTICIPANTS HAVE NOT ADDRESSED?
I THINK OUR PANELISTS HAVE VERY
SHY TODAY.
>> I HAVE A QUESTION AND THAT IS
AFTER TODAY EITHER DOES -- DO SH
THIS IS SUSAN, DO PEOPLE THAT
ARE PREDOMINANTLY DEAL WITH
ENDOMETRIOSIS PATIENTS, HAVE --
DID YOU LEARN ANYTHING DIFFERENT
ABOUT VULVODYNIA PATIENTS TODAY
OR -- DO PEOPLE WHO
PREDOMINANTLY DEAL WITH
VULVODYNIA PATIENTS DID YOU
LEARN ANYTHING DIFFERENT ABOUT
VULVODYNIA PATIENTS VERSUS
ENDOMETRIOSIS PATIENTS IN TERMS
OF HOW THEY COME TO THE TABLE
AND WHAT THEIR SPECIFIC NEEDS
ARE AND WHAT THEIR DESIRES ARE
FROM RESEARCH PROTOCOLS AND OR
TREATMENTS. ONE THING THAT
STICKS OUT TO ME I WILL START
BECAUSE I WORK PREDOMINANTLY
WITH VULVODYNIA BY BUT I ALSO
WORK WITH OTHER PATIENTS.
AND THERE'S MORE WITH ENDO
PATIENTS THAN THE VULVODYNIA.
IN TERMS OF OPIOID USE I SEE
MORE OF THAT IN THE ENDO IC
COMMUNITY AND VULVODYNIA
PATIENTS SHY AWAY FROM OPIOID
USE. THEY DON'T REALLY LIKE OIP
EYED USE AND REALLY RUN FROM
THAT AND RUN THAT FROM THAT AS
AN ANSWER.
THEY ARE MORE I GUESS AMENABLE
TO BENZOS OR DIAZEPAM
SUPPOSITORIES BUT NOT REALLY
OPIOIDS THAT'S AN INTERESTING
DISTINCTION FOR ME AT LEAST BY A
UNIFYING PORTION BETWEEN BOTH
CADRES OF PATIENTS IS THAT IF
ANYTHING IN THE CBD/THC SPACE
COULD WORK FOR THEM THEY WOULD
BE VERY, VERY EXCITED ABOUT
THAT. THOUGHTS?
>> I DO BELIEVE THAT RESEARCH
WOULD BE WARRANTED IN THE
THC/CBD SPACE. IT IS--IT HAS
BEEN SLIGHTLY DIFFICULT TO GET
WELL, I DID TRY TO DO AN IND FOR
A CBD SUPPOSITORY FOR PELVIC
PAIN. BUT THAT REQUIRED MUCH
PRECLINICAL WORK THAT,
UNFORTUNATELY, WOULD BE VERY
COSTLY AND DOESN'T SEEM TO BE
ANY -- COMPANIES ARE WILLING TO
DO THE PRECLINICAL WORK GIVEN
THAT IT'D BE DIFFICULT TO PATENT
SUCH A PRODUCT OR THAT OTHER --
BECAUSE CBD AND THC IS SO NOW
WIDELY AVAILABLE THERE'D BE NO
RETURN ON INVESTMENT EVEN IF
THERE WAS PROVEN IN A CLINICAL
TRIAL FOR -- TO MOVE FORWARD IN
A, YOU KNOW, TO GET FDA
APPROVAL. SO I DID HAVE AN IND
SUBMISSION THAT I HAD TO
WITHDRAW BECAUSE OF THE
REQUIREMENTS OF SO MUCH
PRECLINICAL WORK THAT THE FDA
WANTED AND THAT WAS DISCUSSED IN
THE DRAFT GUIDANCE.
>> THAT'S A GOOD POINT. THANK
YOU
YOU.
>> I WILL SAY THAT YOU RAISE AN
INTERESTING TOPIC. I THINK EVEN
IF YOU'RE NOT FOCUSED ON
STUDYING A CBD OR THC PRODUCT
YOU MIGHT CONSIDER COLLECTING
DATA ON CANNABIS USE
PARTICULARLY IN YOUNGER
POPULATION OF FOLKS WHO ARE
LIKELY TO SELF-MEDICATE WITH
CANNABIS. NOT TO RULE IT OUT OR
MAKE AN EXCLUSION CRITERIA BUT
TO FACTOR IT IN WHEN IT COMES TO
DETERMINING WHETHER OR NOT YOUR
PRODUCT IS MORE EFFECTIVE THAN
PLACEBO IF THERE IS A HUGE
IMBALANCE IN THE CANNABIS USE
THAT CAN BE TELLING. IT'S VERY
SIMILAR TO HOW WE APPROACH IN
THE AREA OF RESCUE MEDICATION.
SO IF YOUR DRUG IS WORKING WELL
COMPARED TO PLACEBO, THAT MAY BE
CONFOUNDED BY THE NEED TO
INCREASE RESCUE MEDICATION. SO
JUST THE MORE DATA YOU CAN
COLLECT TO BRING TO BARE ON WHAT
HAPPENING WITH THESE MEDICATIONS
THE BETTER YOU'LL BE.
>> IT'S INTERESTING YOU BRING UP
THC AND CBD, ONE OF THE SIDE
CONVERSATIONS AT THE HEAL EVENT
A COUPLE MONTHS AGO THERE WAS A
DISCUSSION OF SILL LA SAY BIN.
AGAIN THAT'S ANOTHER MOON SHOT
BUT HAS ANYBODY TALKED ABOUT
THAT THE USE OF SILL LA SAY BIN.
IS THAT RIGHT, SUSAN?
>> YEP.
>> THE END RESULT IS ALWAYS
THESE CONVERSATIONS WE NEED TO
CONTINUE TO DO WELL-DESIGNED
CLINICAL TRIALS TO TRY TO
ACCOUNT FOR AS MANY VARIABLES AS
POSSIBLE IN A VERY HETEROGENOUS
POPULATION OF GYNECOLOGIC PAIN
PATIENTS BUT THAT WE DO NEED TO
KEEP MOVING FORWARD TO HELP THE
MANY MILLIONS OF WOMEN WHO ARE
SUFFERING FOR TIME OF PAIN WE
SPENT THE LAST FOUR AND A HALF
HOURS TALKING ABOUT TODAY.
>> THANK YOU VERY MUCH,
DR. GOLDSTEIN. AND ALL THE
SPEAKERS. AND THANK YOU. I
REALLY APPRECIATE YOU STAYED
WITH US UNTIL THE END OF THE
MEETING. I AM SO GRATEFUL FOR
ALL THE SPEAKERS WHO GAVE THE
WONDERFUL TALKS. IT WAS MY
GREAT PLEASURE TO MEET YOU ALL
AND LEARN MORE ABOUT GYNECOLOGIC
PAIN RESEARCH AND THE RECORDING
WITH SPEAKER'S APPROVAL WILL BE
POSTED ON THE WEB PAGE AFTER
THIS MEETING. IF YOU WOULD LIKE
TO SHARE YOUR RESEARCH FINDINGS
AT OUR NEXT MEETING IN 2025
PLEASE E-MAIL ME AND IF YOU HAVE
ANY OTHER QUESTIONS OR FEEDBACK,
PLEASE FEEL FREE TO CONTACT US
ANYTIME AND THANK YOU VERY MUCH
FOR JOINING US TODAY AND HAVE A
GOOD NIGHT AND BYE, EVERYONE.
>> THANK YOU, HELENA.
>> THANK YOU SO MUCH.
>> THANKS, HELENA, BYE,
EVERYONE.
>> THANK YOU. BYE.