>>TODAY WE HAVE OUR FIRST
PRESENTATION FROM DIVISION OF
CANCER PREVENTION, AND THE
VISION.
THIS WILL BE PROVIDED I BE DR.
CASTLE, DIRECTOR FOR THE
DIVISION FOR CANCER PREVENTION.
PHIL.
>>
>> THANK YOU, EVERYONE.
THANKS FOR THE OPPORTUNITY TO
SPEAK.
WHAT I WANTED TO DO TODAY IS
TALK A BIT ABOUT WHERE DCP IS
TODAY AND WHERE WE ARE GOING.
AND I ALSO WANT TO EMPHASIZE
THAT I'M SPEAKING ON BEHALF OF
THE DIVISION AND EVERYTHING I'M
PRESENTING IS REALLY A
REFLECTION OF AMAZING STAFF THAT
IS HARDWORKING AND DEDICATED TO
PUBLIC SERVICE.
NOT MOVING FORWARD.
OKAY.
SO JUST TO ORIENT YOU A LITTLE
BIT THIS SLIDE HIGHLIGHTS THE
FACT WE HAVE NOT MADE THE KIND
OF PROGRESS WE WANT TO MAKE IN
PREVENTING CANCER.
THIS IS A COUPLE OF YEARS OLD
BUT YOU ESSENTIALLY WERE AT FLAT
LINE HERE.
THANK GOODNESS WE ARE MAKING
SOME PROGRESS IN REDUCING CANCER
DEATH BUT THAT JUST MEANS ALSO
WE HAVE MANY PEOPLE MOVING WITH
CANCER WHO WE WOULD LIKE TO
REDUCE THAT AND MAKE LIVES
BETTER.
KEEP IN MIND $200 BILLION ARE
SPENT ON CANCER CARE EVERY YEAR.
ABOUT 10% IS OUT OF POCKET
EXPENSES.
THIS IS THE NEW MISSION
STATEMENT FOR DIVISION OF CANCER
PREVENTION, NCI DIVISION CANCER
PREVENTION LEADS AND SUPPORTS
PROMOTES RIGOROUS INNOVATIVE
TRAINING CANCER TO IMPROVE
HEALTH OF ALL PEOPLE.
THIS IS THE STAFF, THE
LEADERSHIP DIVISION OF THE
BRANCHES WITHIN THAT SO WE HAVE
TEN BRANCHES, ONE PROTOCOL
INFORMATION OFFICE AND CANCER
PREVENTION FELLOWSHIP PROGRAM.
SO REALLY THE DIVISION OF CANCER
PREVENTION DOES DISCOVERY AND
DEVELOPMENT OF CANCER PREVENTION
STRATEGIES, WE WORK VERY CLOSELY
WITH THE DIVISION OF CANCER
BIOLOGY AS WELL AS DIVISION OF
CANCER CONTROL AND POPULATION
SCIENCES AND WE EMPHASIZE YOU
WILL SEE THAT IN THE UPCOMING
SLIDES, THREE AREAS OF RESEARCH,
PREVENTIVE AGENTS AND YOU HEARD
ABOUT THAT FROM SUZUKO
YESTERDAY, WE WILL TALK ABOUT
THAT TODAY.
BIOMARKERS FOR SCREENING AND
EARLY DETECTION, SYMPTOM SCIENCE
PREVENTION AND MANAGEMENT.
IN THE 19 MONTHS I HAVE BEEN AT
DCP WE REALLY ENGAGE THE
EXTRAMURAL AND STAKEHOLDERS AND
DISCUSSIONS ABOUT WHERE WE
SHOULD BE GOING, WE HAD A
MULTI-CANCER EARLY DETECTION
STUDY WORKSHOP CANCER SCREENING,
TRANSLATIONAL ADVANCES AND KAREN
PREVENTION AGENT DEVELOPMENT,
CANDIDATES WORKSHOP AND FNIH
CANCER PREVENTION WORKSHOP, FDA
NCI CLOSING CANCER RISK
REDUCTION WHICH LED TO A NEW FDA
NCI WORKING GROUP AND CANCER
PREVENTION, WE ARE IN THE
PROCESS OF BRINGING ON KOL AND
EXPERT THROUGH IPA MECHANISMS TO
CONTINUE THE DISCUSSION ABOUT
WHERE WE SHOULD BE GOING.
OBVIOUSLY THIS DISCUSSION TODAY
AND THEN WE ARE -- WE HAVE NEW
ENGAGEMENTS WITH INDUSTRY
PARTNERS WHICH VERY EXCITING AS
WELL.
SO THIS IS WHERE WE ARE AT.
AND I REMIND YOU THAT MANY
THINGS HERE AVOIDING VACCINATION
TREATMENT AND SCREENING ARE
TOOLS -- NOT AVOIDING THOSE,
THEY ARE THE SAME TOOLS
HIGHLIGHTED BY THE COVID
PANDEMIC.
AVOIDING TOBACCO AND TOBACCO
CESSATION FOR SECONDARY AND
VACCINATION TREATMENT OF H
PYLORI AND SCREENING DIAGNOSIS
AND REMOVAL OF ADENOMA TISSUE.
THE INTERCEPTION OF CANCER TO
DATE HAS BEEN STARTING TO EXPAND
BUT STILL NOT WHERE WE NEED IT
TO BE.
TAMOXIFEN AND DERIVATIVES FOR
BREAST CANCER COLORECTAL CANCER
N SAID, IMMUNE MODULATORS LIKE
STAT 3 INHIBITORS, DRUG THAT
TARGET ONCOGENIC DRIVERS AND
REACTIVATION OF TUMOR SUPPRESSER
GENES.
I WOULD LIKE TO FRAME THE WORK
WITH A TEAGUE LINE ACROSS
TRANSLATION RESEARCH CONTINUUM.
YOU HEARD ABOUT PREVENT
YESTERDAY, AND SUSUKO MENTIONED
OUR EIGHT NEW AGENT TARGET
DISCOVERY PROGRAM.
THEN THESE VIEWED INTO CPT NET
EARLY PHASE CLINICAL TRIALS AND
THE NCOR LED BY CONFIDENTLY LED
BY MCCAUSE SKILL STEVENS.
WE HAVE COMPLIMENTARY ACTIVITIES
WHICH IS FOCUSED ON HPV
PREVENTION STRATEGIES AND PEOPLE
LIVING WITH HIV, THE CANCER
PREVENTION AND CONTROL CLINICAL
TRIALS PAR AND WE ARE JUST
STARTING A PLANNING FEEDSIBILITY
GRANT MECHANISM R 33 U 33
BECAUSE PREVENTION TRIALS ARE SO
DIFFICULT WE FELT THAT THIS IS
LED BY BRANDY TO -- IT WOULD BE
BENEFICIAL TO HAVE SOME PILOT
DATA BEFORE LAUNCHING INTO LARGE
CLINICAL TRIALS.
SO YOU HEARD ABOUT THIS
YESTERDAY ABOUT PREVENT PROGRAM,
I WANT TO HIGHLIGHT AGAIN IT IS
A MULTI-STEP PROCESS TO GO FROM
DISCOVERY INTO VALIDATION AND
EFFICACY WITH LOTS OF GO, NO
GOs AND REVIEWS ALL ALONG THIS
PIPELINE.
SO I WANT TO CONGRATULATE DR.
SAY AND DR. SHOEMAKER FOR THEIR
AMAZING LEADERSHIP OVER THE LAST
TEN YEARS IN THE COMING FIVE
YEARS SINCE WE APPROVED THIS
PROGRAM THANKFULLY, A
FOUNDATIONAL PROGRAM FOR THE
DIVISION.
THEN WE HAVE THE CPCT NET LED BY
DR. ZABO REALLY PHASE ZERO PHASE
1, PHASE 2 TRIALS YOU CAN SEE
THE ADMINISTRATIVE OFFICES AND
THE DMACC, ACROSS THE UNITED
STATES SO FAIRLY REPRESENTATIVE
OF THE UNITED STATES WITH THE
IDEA THAT THIS WOULD THEN FEED
INTO NCOR FOR PROMISING AGENTS
THAT CAME OUT OF CPCTNET.
SOME EXAMPLES OF PROTOCOLS AND
CPCTNET WITH SENOPRIL, HERE FOR
NON-ALCOHOLIC FATTY LIVER
DISEASE, SOME WORK ON MONOVALENT
PROPHYLACTIC HPV VACCINATION,
PROSTATE CANCER PATIENTS, SOME
WORK ON METAPHORMAN AND SO
FORTH.
THIS IS JUST A TIP OF THE
ICEBERG, THERE IS ANOTHER DOZEN
PROTOCOLS LINED UP TO BE
LAUNCHED IN CPCTNET IN THE
FOLLOWING YEAR OR SO.
ANOTHER IMPORTANT COMPONENT OF
THE DIVISION IS SCREENING AND
EARLY DETECTION. MORE AND MORE
THINKING RISK INFORMED SCREEN
HIGHER THE RISK MORE SCREEN
DIFFERENTIAL MANAGEMENT AND ALSO
POTENTIAL FOR INTERVENTION WITH
TARGETED PREVENTIVE AGENTS.
TODAY WE ARE SOMEWHAT LIMITED TO
BREAST CERVIX COLORECTAL LUNG
HCV FOR LIVER AND PROSTATE IN
SELECT POPULATIONS.
OBVIOUSLY THAT IS NOT ENOUGH AND
THERE'S MUCH MORE WORK TO BE
DONE FOR SCREENING TO REALLY
START TO IMPACT INCIDENCE RATES
OF CANCER AND CANCER MORTALITY.
SO THIS IS IT HAS ACRONYMS AND I
APOLOGIZE KNOW SHY WAY TO LAY
THIS OUT.
I WILL TRY TO EXPLAIN SOME OF
THEM, EDRM IS ESSENTIAL TO
BIOMARKER DISCOVERY AND EARLY
DETECTION PROGRAMS THEN THERE
ARE COMPLIMENTARY PROGRAMS
DEDICATED ONE TO PANCREATIC
CANCER LIVER CANCER, BIAS
CONSORTIM, IMAGING PROGRAM, OUR
NEW PROGRAM DIFFERENTIATE
BETWEEN AGGRESSIVE AND INDOLENT
DISEASE, I MENTIONED BEFORE
WHICH DOVE TAILS INTO A
PRAGMATIC RULE TRIAL FOR SCREEN
FOR ANYONE LIVING WITH HIV.
LAST MILES OUR EFFORT TO GET
WORK WITH THE FDA TO GET
SELF-COLLECTION HPV TESTING
APPROVED FOR CERVICAL CANCER
SCREEN INCOME THE UNITED STATES.
-- SCREENING IN THE UNITED
STATES.
THIS IS THE ERN, AS YOU KNOW
FROM COUPLE OF SESSIONS AGO NOW
IT IS 20, 21EST YEAR A COMPLEX
PROGRAM THAT TOUCHES THE WORLD.
EDRM COLLABORATE IN CHINA,
JAPAN, INDIA, FRANCE.
COLLABORATORS, 350 ASSOCIATE
MEMBERS FOCUSED ON PROSTATE
NEUROLOGIC DISEASE BREAST AND
OTHER GYNECOLOGIC LUNG UPPER AIR
DIGESTIVE COLON AND UP PER GI.
THIS IS THE NCOR, HIGHLIGHT
REDIRECT EXAMINATION MINORITY
CENTERS.
AND TREMENDOUS LEADERSHIP JOB TO
KEEP THIS PROGRAM GOING AND
GROWING.
NOW OVER A THOUSAND CLINICAL
SITES THROUGH 46 CENTERS AND
AFFILIATES AND THOUSANDS OF
INVESTIGATORS. A NATIONAL
INTERNATIONAL PROGRAM ON CANCER
PREVENTION CONTROL AND ONCOLOGY.
JUST TO UPDATE YOU ON TEAMNESS
SINCE THIS WAS MY FIRST
INTRODUCTION BSA 18 MONTHS OR
SO, THE PRIMARY END POINTS
REMAIN ADVANCE CANCER BUT
THERE'S SOME MODIFICATIONS,
ADVANCED CANCER FIXED TIME
PERIOD FOUR AND A HALF YEARS
REVITALIZATION.
ADVANCE CANCER ANY TIME UP TO
SEVEN YEARS FROM RANDOMIZATION.
WE LOWERED THE POWER FROM 85% TO
90% TO REDUCE SAMPLE SIZE BY
36,000 BUT THE DERIVATION OF
SAMPLE SIZE CONTINUES TO ASSUME
20% RELATIVE REDUCTION IN H
ADVANCE CANCER FOUR AND A HALF
YEARS FOLLOWING RANDOMIZATION.
THE READ OUT EXPECTED BY MID
2027.
HERE IS UPDATED ACCRUE THANK YOU
TO WARTA'S TEAM FOR PROVIDING
THAT.
YOU CAN SEE THE DIP FOLLOWING
ONSET OF PANDEMIC BUT THEIR
CREDIT THEY ARE CONSISTENTLY
ABOVE 2000 ENROLLMENTS MONTHLY
AND AS OF 12, 1, 2021 AT 60,000,
HALF THE ENROLLMENT.
HERE ARE SOME OF THE OTHER
ACTIVITIES IN THE NCOR.
3-D MAMMOGRAPHY.
PORTE JUST LAUNCHED TO LOOK AT
WHETHER FIVE VERSUS TEN YEAR
COLONOSCOPY FOR LOW GRADE
POLYPS.
T A IMMUNE CHECK POINT
OPTIMIZING FUNCTIONAL OUTCOMES
OVER CANCER SURVIVORS AFTER
CHEMOTHERAPY WE HAVE CYST
SURVEILLANCE PROJECT, LOOKING AT
SURGICAL REMOVAL OF OVARIES
VERSUS OVARIES AND FA LOANIAN
TUBES REDUCING RISK OF OVARIAN
CANCER IN BRACA 1 PATIENTS.
THERE HAS BEEN TALK AND INTEREST
IN LIQUID BIOPSY CALLING NOW
MULTI-CANCER EARLY DETECTION
PREVENTION SPACE, AND SO ABOUT
12 MONTHS AGO UNDER NED'S
ADVISEMENT AND LEADERSHIP WE
HAVE STOOD UP A TRANSNCI, BEYOND
NCI WE HAVE FOLKS FROM CMS FDA
SITTING IN ON MEETINGS.
LOOKING AT EVERYTHING FROM BASIC
SCIENCE WHY THESE MARKERS
GETTING BLOOD AND WHAT IS BASIS
OF HETEROGENEITY IN THOSE BLOOD
BORN MARKERS, HOW TO USE COHORT
STUDIES TO STUDY NATURAL HISTORY
OF THESE BIOMARKERS.
TO AND I WILL TALK ABOUT THIS IN
A SECOND, THE NEED FOR RANDOMIZE
CLINICAL TRIALS TO REALLY
UNDERSTAND THE BENEFITS AND
HARMS OF THESE INTERVENTIONS,
THESE ASSAYS, THESE TECHNOLOGIES
TECHNOLOGIES.
WE HAD N SAID STUDY DESIGN
WORKSHOP, INCREDIBLY COMPLICATED
TO LOOK AT MULTI-CANCER EARLY
DETECTION, LED BY LORI MINASIAN
MY DEPUTY DIRECTOR.
THE OUTCOMES FROM THE WORKSHOP
REALLY WHAT WE KNOW IS THE MCED
ASSAYS HAVE LIMITED SENSITIVITY
OR AT BEST MODEST SENSITIVITY
FOR EARLY STAGE GREATER FOR
ADVANCE STAGE, SPECIFICITY
REMAINS -- APPEARS TO BE HIGH
BUT WE DON'T KNOW WHAT THE
BENEFITS ARE OF THESE TESTS.
THEY BIND CANCER BUT WE DON'T
KNOW IF THERE IS END STAGE SHIFT
OR MORTALITY BENEFIT AND WE
CERTAINLY DON'T KNOW WHAT THE
HARMS ARE.
THERE ARE SOME NOVEL
IMPLEMENTATION CHALLENGES, HOW
QUICKLY AND RELIABLY WE CAN FARM
CANCER STATUS IN SIGHT AFTER
POSITIVE TEST.
HOW BEST TO SCREEN MULTI-CANCER
WITH DIFFERENT LATENCY PERIODS.
ARE ALL TESTS THE SAME FOR ALL
THE POPULATION GIVEN THEY TARGET
DIFFERENT BIOMARKERS AND HOW
WELL ARE THOSE BIOMARKERS
REPRESENTED ACROSS THE
POPULATION.
WE DON'T KNOW ANY OF THOSE
THINGS.
THERE IS UNIFORM AGREEMENT, THIS
WAS A MEETING OF 60 EXPERTS THAT
THE NCI MEETS TO SUPPORT A TRIAL
TO EVALUATE THESE TECHNOLOGIES.
THERE ARE A LOT OF UNKNOWNS,
THIS IS JUST THE TIP OF THE
ICEBERG AND WE HAVE PAGES OF
VARIABILITY AND DIAGNOSTIC WORK
UP, DIFFERENT ASSAY TO PROVIDE
TISSUE OF ORIGIN, NOT ALL OF
THEM, EVEN IF YOU HAVE A TISSUE
LOCATER WE DON'T KNOW -- WE
HAVEN'T WORKED THROUGH WHAT IS
THE DIAGNOSTIC RESOLUTION AND
WHAT YOU DO IF YOU DON'T FIND
CANCER WHERE YOU ARE SUPPOSED TO
FIND IT.
SO WE NEED TO ASSESS WHAT THE
PROCESS WOULD BE AND WHEN TO
STOP THE WORK UP.
ADDITIONAL THEMES, ENSURING
ENROLLMENT OF VARIOUS POPULATION
POPULATIONS AND THIS IS A POINT
DR. SHARPLESS HAS EMPHASIZED
FROM THE BEGINNING WE NEED TO
MAKE SURE THE REPRESENTATIVE
POPULATIONS INCLUDING
UNDERSERVED, HAS TO BE DIVERSE,
WE HAVE TO REACH VULNERABLE
POPULATIONS THAT GET GREATEST
BENEFIT AS WE AS WE ALL REALIZE HOW TO
INCORPORATE HIGH RISK
POPULATIONS.
WE NEED COMMUNICATION STRATEGY
FOR THE TRIAL AND IN GENERAL
ABOUT THIS BECAUSE AS YOU KNOW A
LOT IS GOING DIRECT TO CONSUMER,
BEING OFFERED WITHOUT FDA
APPROVAL.
WE NEED TO ASSURE ADEQUATE
FOLLOW-UP TO MAKE SURE PEOPLE
GET WHAT THEY NEED FOR CARE.
OBVIOUSLY THE FIRST TWO WHAT I
CALL MY HOLY GRAIL YOU SEE TWO
PIPELINES I PRESENTED COME
TOGETHER.
WHERE A BIOMARKER CAN BE USED TO
IDENTIFY SOMEBODY AT RISK AND
THEN WE HAVE REMOVAL A WHOLE
TISSUE, GOING FORWARD.
SO I HOPE IN MY TIME AT DCP WE
WILL SEE A TRIAL THAT BRINGS
THOSE TWO ELEMENTS TOGETHER.
THEN FINALLY SYMPTOM SCIENCE
SITS IN DCP.
I THINK THIS HAS A TREMENDOUS
GROWTH POTENTIAL, REALLY WE NEED
-- WE MOW VERY WELL THAT BETTER
SYMPTOM SCIENCE BETTER SYMPTOM
MANAGEMENT CAN ONLY BENEFIT
CANCER PATIENTS AND THEIR
ABILITY TO GET ADDITIONAL
THERAPIES.
SO HERE IS OUR PIPELINE HERE, WE
HAVE A VARIETY OF RFAs AND
PFAR AND RFAs TO SUPPORT EARLY
DISCOVERY AND TRANSLATION TO
HUMANS AND NCORP AT THE CENTER
OF SYMPTOM SCIENCE ACTIVITIES.
WE HAVE MOON SHOT TOLERABILITY
CONSORTIUM FOCUSED ON HELPING US
TO FIND END POINTS.
SO SYMPTOM MANAGEMENT TOXICITY
MITIGATION, UNDERSTANDING
MECHANISMS OF ACTION FOR CHRONIC
ADVERSE EFFECTS.
CHARACTERIZE CLINICAL SYNDROMES
FOR TOXICITY AND SYMPTOMS,
CAPTURE HOW THE PATIENT
FUNCTIONS AND FEELS, THROUGH
PATIENT REPORTED OUTCOMES.
THERE IS A HEAVY RELIANCE ON
CLINICAL READ OUTS, CLINICIAN
REPORTS OF THIS AND WE SEE THE
DATA THE CORRELATIONS ARE NOT
THAT GREAT AND WE NEED TO FIGURE
OUT HOW TO COLLECT THE PATIENT
EXPERIENCE AND BASE OUR
MANAGEMENT ON THAT AS MUCH AS
CLINICAL READ OUTS.
THESE ARE THE TRANSNCI RESEARCH
OPPORTUNITIES, PROVOCATIVE
QUESTION WHAT ARE MOLECULAR
CELLULAR MECHANISMS THAT
UNDERLIE DEVELOPMENT OF CANCER
THERAPY INDUCED SERIOUS SEVERE
ADVERSE SEQUELAE, CLINICAL
CHARACTERIZATION OF CANCER,
THERAPY INDUCED SEQUELAE AND
MECHANISM BASED INTERVENTION
STRATEGIES AND ANALYZING
INTERPRETING CLINICAL AND
PATIENT ADVERSE EVENT DATA TO
BETTER UNDERSTAND TOLERABILITY.
WHAT THIS IS LEADING TO IS
PRECISION SYMPTOM MANAGEMENT.
AND PREVENTION.
BUT THE IDEA WE ARE APPLYING THE
SAME IDEAS THE SAME TECHNOLOGIES
FOR HOW WE TREAT PATIENTS AND
PREVENT THEM AND NEED TO DO SAME
FOR SYMPTOM MANAGEMENT, THAT IS
POSSIBLE.
I WANT TO HIGHLIGHT SEVERAL
ALEXIS BAK ONS AND SEVERAL
MEMBERS FROM THE DIVISIONS HAD A
WORKSHOP THIS YEAR AND THE
MONOGRAPH IS PUBLISHED LAST
WEEK.
IT IS A CUTTING EDGE LOOK AT
CANNABIS USE IN CANCER CONTROL
CARE.
SO SOME OF PROPOSED DCP
PRIORITIES, AND MY FINAL
COMMENTS BIOLOGICAL POPULATION
RISK INFORMED INTERVENTIONS
OBVIOUSLY BIOLOGY TELLS US ABOUT
HOW TO TARGET AND PREEVENTUAL
POPULATION WHICH TELLS US WHO
NEEDS IT.
OBESITY CONTINUES TO PLAGUE US
IN THE SENSE THAT 20% CANCER ARE
ATTRIBUTABLE TO CANCER BUT WE
DON'T KNOW UNDERSTAND HOW
OBESITY CONTRIBUTES TO
CARCINOGENESIS.
IF WE DID WE COULD MITIGATE
EFFECTS AND I DON'T THINK WE
SHOULD WAIT FOR BEHAVIORAL
INTERVENTIONS TO SOLVE THIS
PROBLEM BECAUSE WE SHOULD INVEST
IN THAT BUT THE FACT IS WE HAVE
COHORT OF PEOPLE WHO HAVE BEEN
OBESE AND HAVE BEEN EXPOSED TO
THESE CARCINOGENS.
AS I EMPHASIZE WE NEED TO DONOR
SYMPTOM SCIENCE PRECISION
SYMPTOM PREVENTION MANAGEMENT.
HOW DO WE USE BIOLOGY GENETICS
AND EPIDEMIOLOGY TO UNDERSTAND
ETIOLOGY SYMPTOMS.
EXPLAIN ADVERSE RESPONSES TO
TREATMENT AND REMOVE SYMPTOM
MANAGEMENT FROM TRIAL AND ERROR
TO PRECISION MEDICINE.
HEALTH DISPARITIES I WORKED 20
YEARS IN HEALTH DISPARITIES,
NEAR AND DEAR TO MY HEART, MUCH
OF MY INTEREST IN THIS IS REALLY
HOW WE DO INNOVATIVE OR HOW DO
WE INN INVESTIGATE IN TECHNOLOGY
-- INNOVATE IN TECHNOLOGY
SELF-SELECTION POINT OF CARE
TESTING TO BRING STANDARD CARE
OR BETTER FOR UNDERSERVED
POPULATIONS PARTICULARLY HIGH
RISK OF CANCER.
WE TALK ABOUT GENETIC
PRE-DISPOSITION FOR CANCER AS
HIGHER RISK, THIS IS ALSO HIGH
RISK GROUP AND WE NEED TO GET
AFTER IT.
WE ARE INUNDATED WITH NEW
TECHNOLOGIES, ARTIFICIAL
INTELLIGENCE, IF THIS IS LIKE --
ARTIFICIAL INTELLIGENCE LIKE THE
MICROBIOME TEN YEARS AGO,
EVERYONE THAT COMES IN WITH
ARTIFICIAL INTELLIGENCE ANGLE,
WE NEED TO BE ABLE TO
DISTINGUISH BETWEEN WHAT IS GOOD
AND WHAT IS NOT.
SO WE ARE GOING TO -- WE ARE
GOING TO MAKE AN INVESTMENT BOTH
IN STAFFING AND OUR KNOWLEDGE TO
GET AFTER THIS.
I HAVE TALKED MULTI-CANCER EARLY
DETECTION.
AND IMMUNOLOGY AND PREVENTIVE
VACCINATION HAS BEEN TALKED
ABOUT, WHAT CONSTITUTES AN
EFFECTIVE IMMUNE RESPONSE TO
CARCINOGEN INSULT.
AND INVESTMENT IN NEOANTIGEN
IDENTIFICATION AND VALIDATION.
MY FINAL COMMENT IS O TO SAY WE
NEED TO REDEFINE PRECISION
CANCER PREVENTION TO PROMOTE
HEALTH EQUITY.
MAXIMIZE THE BENEFITS AND HARMS
FOR THE ENTIRE POPULATION NOT
FOR SELECT POPULATION,
UNDERSTANDING ALL CAUSES OF
DIFFERENCES, NOT JUST BIOLOGICAL
INFORMS HOW WE CAN BE MORE
PRECISE.
SO WHO, AGAIN POPULATION RISK,
WHAT USING BIOLOGIC RISK TO
TARGET WE CAN ADD INTO THIS
EQUATION INCREASING ACCESS TO
ALTERNATIVE HEALTHCARE DELIVERY
STRATEGIES, AND HOW WE CAN USE
DIFFERENT DELIVERIES LIKE
TOPICAL TAMOXIFEN DERIVATIVES TO
INCREASE BIOAVAILABILITY AT THE
TARGET SITE AND LIMIT SYSTEMIC
EXPOSURE AND REDUCE TOXICITY AND
HARMS SO I WANT TO FINISH, I
THINK I STOLE THIS SLIDE FROM
DOUG LOWY.
JUST A DISCLOSURE THERE, I WANT
TO REALLY THANK THE STAFF AT DCP
WHO DO AMAZING JOB EVERY DAY AND
WELCOMED ME WITH OPEN ARMS, IT
HAS BEEN A THRILL TO WORK WITHIN
THE LAST 19 MONTHS, I WANT TO
ACKNOWLEDGE DEN BRA WHEN WHO
MADE IT A CRAZY TIME TO COME TO
NCI.
NCI LEADERSHIP NED SHARPLESS
UNDER LEADERSHIP AND MENTORSHIP.
I HAVE KNOWN DOUG 20 YEARS AND
ME PROVIDES SAGE ADVICE.
BOB DAN STEVEN TOMMY SHE WOULD
ALL HELPED GETTING THESE GREAT
REVISED HEALTH, A SHOULDER TO
CRY ON WHEN NOT GOING QUITE THE
WAY I WANT.
SO I CAN'T THANK THEM ENOUGH FOR
ALL THE THEY DO AND THE SUPPORT
THEY HAVE GIVEN THEM AND WITH
THAT I WILL TAKE ANY QUESTIONS.
THANK YOU SO MUCH.
>> THANK YOU SO MUCH, PHIL.
THANK YOU FOR STAYING ON TIME
AND BEING DIRECT AND SUCCINCT
BUT FANTASTIC AND FASCINATING
PRESENTATION.
I'LL ASK THE FIRST QUESTION
MICHELLE'S HAND AS WELL, A
NUMBER OF HANDS SO WHERE DOES
FOR INSTANCE RISK OR RISK
ASSESSMENT FALL WITHIN THIS AND
HOW IS IT BEING INTEGRATED?
I KNOW WE HAVE THE INTRAMURAL
PROGRAM UNDER STEVE.
WE ALSO HAVE BOB'S PROGRAM, I
KNOW A LOT OF THAT WORK
PERMEATES IN THOSE SPACES BUT
HOW ARE YOU INTEGRATING THE
WHOLE CONCEPT OF RISK.
RISK ASSESSMENT FROM THE
STANDPOINT OF GENETIC RISK OR
POLYGENIC RISK SCORES, YOU
MENTION YOU TOUCHED ON IT, HOW
DOES THAT INTEGRATE INTO THE
VISION IN THE FUTURE FOR
PREVENTION?
>> GREAT QUESTION, JOHN.
I APOLOGIZE, I GAVE YOU A
100,000 SO I MEAN CAN'T COVER A
PROGRAM IN 20 MINUTES.
CERTAINLY WE ARE TALKING ABOUT
AND JUST JOIN SOD WE HAVEN'T HAD
A DEEP CONVERSATION ABOUT HOW TO
USE IT.
THE DATA IS STARTING TO COME OUT
WHERE WE CAN USE POLYGENIC RISK
SCORE PARTICULARLY IN THE
SCREENING CONTEXT WITH PROSTATE
AND BREAST CANCER.
ACTUALLY STEVEN AND I HAVE BEEN
TALKING ABOUT WHETHER WE CAN
STAND UP A PROS SATE CANCER
SCREENING TRIAL WITH LOTS OF
ISSUES HOW TO DO THAT.
KEEP IN MIND PEOPLE FOCUS ON
POLYGENIC RISK SCORE JUST FOR
SCREENING.
YOU CAN THINK POLYGENIC RISK
SCORE ACROSS THE ENTIRE CARE
CONTINUUM.
IN FACT I WOULD LIKE TO USE MY
EXPERIENCE AND 15 YEARS AGO I
PROPOSED MANAGEMENT BASED ON
RISK IN THE CERVIX WORLD AND NOW
THAT HAS BECOME THE FOUNDATION
FOR HOW DECISIONS HAVE BEEN --
ARE BEING MADE.
SO I WANT TO BRING THAT
EXPERIENCE TO THIS WORKING WITH
THE OTHER DOCTORS TO IMPLEMENT
THAT.
I THINK THE OTHER ISSUE, SURE
MANY OF YOU APPRECIATE,
EVERYBODY HAS THEIR RISK
CALCULATOR.
MOST OF THEM A LOT OF ACADEMIC
INSTITUTIONS DO.
THEY HAVEN'T BEEN VALIDATED OR
THEY HAVE BEEN VALIDATED WITHIN
THEIR POPULATION, NOT
NECESSARILY OUR -- SO WE HAVE TO
GET OUR HEADS AROUND THAT.
THE FINAL THING, WE ARE WORKING
WITH DCCPS, PAUL HOTT, THE OTHER
CHALLENGE IS HOW TO COMMUNICATE
ABOUT THIS.
BECAUSE AT INDIVIDUAL LEVEL,
PAUL TAUGHT ME THIS, IT WAS AN
EYE OPENING THING, THAT PEOPLE
DON'T EXPERIENCE 10% RISK THEY
EITHER GET CANCER OR DON'T.
THAT'S THE REALITY SO I THINK WE
SAW THIS PLAY OUT WITH THE
PANDEMIC, THE PEOPLE DON'T
REALLY FUNDAMENTALLY UNDERSTAND
RISK AND HOW IT RELATES TO THEM.
SO WE HAVE TO DO A BETTER JOB OF
COMMUNICATING ABOUT THAT.
PARTICULARLY RECRUITING FOR
TRIALS.
PEOPLE DON'T UNDERSTAND THEY
WON'T GO HEY I WANT TO BE ON
THAT TRIAL.
WE ARE AT THE BEGINNING OF USING
RISK NOT IN THE MIDDLE.
>> GREAT.
THINKING HOW IT INTEGRATE ACROSS
VARIOUS PROGRAMS.
THAT IS IN PLACE, COMMUNICATING
TALKING TRYING TO FIGURE OUT HOW
TO BEST IMPLEMENT ONCE VALIDATED
AND READY FOR PRIME TIME.
SO THERE ARE NUMBER OF HANDS, I
THINK I SAW THE ORDER, WE WILL
START WITH MICHELLE, GO TO ANDY
AND ANDREA AND THEN KAREN.
>> THANK YOU, DR. CASTLE FOR
THAT TERRIFIC TALK.
I'M DELIGHTED THAT NCI FOCUSING
ON MULTI-CANCER EARLY DETECTION
TESTS AND MY QUESTIONS TO YOU,
HOW ARE YOU THINKING ABOUT THE
TEST -- ARE YOU THINKING
INCLUSIVELY OF TEST BEYOND DNA
AND RNA, THINKING PROTEIN,
LIQUID BIOPSIES, BREATH AND
OTHER URINE OTHER TYPES OF
TESTS?
AND HOW DO YOU ENVISION
STRUCTURING CLINICAL TRIALS TO
ENSURE WE HAVE SUFFICIENT
REPRESENTATION OF
UNDER-REPRESENTED POPULATIONS?
BECAUSE I THINK THIS IS THE
BIGGEST CONCERN WE ALL HAVE
REGARDING THESE.
>> LET ME ADDRESS THE LAST ONE
FIRST, HOLD MY FEET TO THE FIRE
ON THE FIRST ONE.
WHEN NED AND I FIRST STARTED
ABOUT THIS, THIS WAS THE FIRST
THING WE GOT TALKING ABOUT, WE
DON'T WANT TO SEE FANCY NEW
TECHNOLOGY EXACERBATING
DISPARITIES WHICH WE HAVE ALL
SEEN OVER AND OVER AND OVER.
>> EXACTLY.
>> SO CERTAINLY IN THE CLINICAL
TRIAL SETTING, ONE OF THE
STRENGTHS OF THE NCOR IF WE WERE
TO DO NCOR BUT THERE COULD BE
OTHER STRATEGIES, AS YOU SAW 20%
NCOR RECRUITMENT ROUTINENESS IS
MINORITIES 28% I DON'T REMEMBER
THE EXACT NUMBER BUT POINT IS WE
HAVE INFRASTRUCTURE TO DO A
TRIAL THAT IS TRULY REPRESENTED
MY CONCERN IF I CAN BE HONEST
BIOMARKERS THAT GO INTO THOSE
TESTS INFORMED BY PREVIOUS
COLLECTION WHERE THERE MIGHT
HAVE BEEN SYSTEMATIC BIAS ABOUT
HOW BIOMARKERS WERE DISCOVERED
CAN'T FIX THAT BUT GOOD TO KNOW
WHETHER THIS WILL WORK WITH
EVERYBODY AND SUBSET, AND HOW TO
IMPROVE THAT.
COMING BACK TO THE FIRST POINT
WE HAVE THE LIQUID BIOPSY
CONSORTIUM WITHIN DCP AND A LOT
OF WHAT YOU WERE TALKING ABOUT
IN TERMS OF DIFFERENT SPECIMENS,
DIFFERENT BIOMARKERS, ET CETERA,
SO SOME BASIC SCIENCE, AROUND
HOW DO WE GET TO SMALLER VOLUME,
CAN WE USE URINE, USE BREATH,
ALL THOSE THINGS.
IN TERMS OF THE CLINICAL TRIAL
I'M AGNOSTIC, I DON'T CARE WHAT
THEY ARE DETECTING.
I CARE ABOUT DO THEY HAVE
SUFFICIENT DATA THAT WARRANTS
INCLUSION IN THE TRIAL?
THEN WE WILL PUT THEM THROUGH
THE PACES.
THERE'S NO OTHER PLACE WHERE WE
CAN REALLY GET HONEST BROKER
READ OUT WHETHER THESE THINGS
WORK SO WHAT WE ARE HOPING TO DO
IS HAVE A PLATFORM TRIAL
RANDOMIZE CONTROL TRIAL, IN
WHICH AS TECHNOLOGIES EMERGE WE
THEN PUT THEM INTO A SEPARATE
ARM OF THE TRIAL COMPARED TO
STANDARD OF CARE.
IF WE CAN IMPLEMENT THAT,
STANDARD OF CARE IS MOVING
PARTICULARLY IF THESE GET OUT
HAND THERE'S CONTAMINATION, THE
OTHER ISSUE IS WE DON'T WANT
PEOPLE TO NOT GET STANDARD OF
CARE, WHILE WE EVALUATE THEY
BENEFIT THE POPULATION.
THERE'S SO MANY ISSUES.
LET ME SAILORRY IS GOING TO COME
AT THE NEXT -- I THINK NEXT
SESSION OR ONE AFTER THAT, NOT
QUITE SURE, REALLY TALK ABOUT
THE DISCUSSION I STARTED HERE.
MUCH FULLER DEPTH PLUS WE WILL
HAVE ANOTHER MEETING
STAKEHOLDERS ON THIS.
SO THIS -- I WANT TO GIVE YOU A
LITTLE HINT, A LITTLE PRIMER
MORE TO COME ABOUT THIS
DISCUSSION WHERE WE ARE GOING
WITH IT.
DID I ADDRESS YOUR QUESTIONS?
>> YES.
THANKS.
>> YOU STRUCK A NERVE, A LOT OF
COOL DISCUSSION.
WE ARE GOING TO GO IN THIS ORDER
WE WILL GO AGAIN TO ANDY,
ANDREA, KAREN AND THEN DEBORAH
AND THEN TO ANNA BARKER IF WE
CAN GET THERE WITHIN THE NEXT
EIGHT MINUTES OR SO.
>> THANKS VERY MUCH FOR SHARING
THAT REALLY EXCITING VISION,
PHIL.
AS WE KNOW WITH PREVENTION ONE
MAJOR BARRIER IS COST OF DOING
CLINICAL TRIALS BECAUSE OF THE
NEED FOR LARGE POPULATIONS.
WHAT ARE THE THOUGHTS ABOUT
USING SOME OF THE STUDIES OR
TRIALS THAT ALREADY UNDERWAY
LIKE FOR DAY OR TEENNESS TO
EMBED OTHER CLINICAL TRIALS
WITHIN THEM LIKE CLINICAL TRIALS
EARLY DETECTION MARKERS, ET
CETERA, IS THAT SOMETHING
ACTIVELY PURSUED OR IS THAT
ALREADY PLANNED?
THE
>> MOST OF THE TRIALS HAVE A
BIOMARKER COMPONENT, TEAMNESS
DOES, ALL THAT BUT HERE IS THE
PROBLEM PARTICULARLY FOR
SCREENING AND EARLY -- THIS IS
JUST MY OPINION.
SO DON'T PUNISH THE REST OF THE
VISION FOR MY VIEW.
ONE IS OBSERVATIONAL.
BECAUSE YOU CAN INTERVENE ON
THAT, OTHERWISE YOU WILL AFFECT
THE MAIN TRIAL.
SO IT IS COUNTER FACTUAL YOU ARE
OBSERVING YOU DON'T KNOW WHETHER
IF YOU ACTED ON THAT IT WILL
BENEFIT THE POPULATION.
SINCE MOST OF THE THINGS YOU
WOULD DO IS NOT GOING TO BE 100%
EFFICACIOUS YOU DON'T KNOW
WHETHER THE ONES THAT YOU
EFFECTED WERE ONES THAT WERE
GOING TO BE ADVANCE CANCER.
WE HAVE STRUGGLED WITH THIS WITH
SCREENING TRIALS, WE HAVE HAD A
NUMBER OF WORKSHOPS ATTENDING A
CRK ONE IN A WEEK TO DISCUSS ARE
THOSE SURROGATE END POINTS
BECAUSE WAITING FOR MORTALITY IS
EXPENSIVE.
AND SO WHERE ARE WE IN SCIENCE
OF END POINTS IS REALLY BEEN
TOPIC SINCE I HAVE COME.
SO IT IS HARD TO EMBED INTO
THOSE STUDIES BECAUSE YOU CAN'T
EFFECT OUTCOME OF THAT STUDY.
WE CAN OBVIOUSLY COLLECT A LOT
OF BIOSPECIMENS, FOR AIS DOING A
TEAMNESS PANCREATIC CYST AND
OTHER TRIALS THAT WILL INFORM
RESEARCH FOR SURE WE HOPE PEOPLE
COME AND USE THAT RESOURCE.
BUT YOU ARE ONLY GOING TO GET SO
FAR AND ULTIMATELY HAVE TO SHOW
THAT IT BENEFIT IT IS POPULATION
DIRECTLY.
IN MY OPINION, YOU MAY DISAGREE.
>> THANKS, PHIL.
ANDREA.
>> THANK YOU VERY MUCH.
I HAVE A QUESTION ABOUT THE
LIQUID BIOPSIES AND I APPRECIATE
THE WORK DONE TO SHOW IT IS
EFFICACIOUS.
I HAVE CONFIDENCE THEY ARE GOING
TO END UP BEING SOMETHING WE USE
WITH TEAM IN THE FUTURE.
WHAT I HOPE IS AS WE ARE
DEVELOPING THEM AND LOOKING AT
THESE CLINICAL TRIALS THAT WE
CAN MAKE SURE THAT THE EASE OF
PROCESSING THE SPECIMENS IS
TAKEN INTO ACCOUNT.
I KNOW SOME OF THESE SPECIMENS
CAN BE FROZEN OR REFRIGERATED,
IF YOU THINK ABOUT SOME SMALL
COMMUNITIES WHERE YOU MIGHT HAVE
MOBILE CLINICS OR RURAL AREAS,
THE EASE OF PROCESSING SPECIMENS
IS SORT OF TAKEN INTO
CONSIDERATION AS WE GET MORE
DOWN THE LINE HOW TO USE THESE
LIQUID BIOPSIES.
>> THAT IS A GREAT POINT.
A LOT OF STUFF HAPPENS AT YOUR
ACADEMIC INSTITUTIONS AND IT
DOESN'T NECESSARILY MEAN IT CAN
BE IMPLEMENTED MORE BROADLY.
SO THAT IS ONE OF OUR GREAT
CONCERNS HOW DO THESE FANCY
TECHNOLOGIES REACH THE PEOPLE
WHO NEED IT THE MOST.
YOU HIGHLIGHTED VERY IMPORTANT
POINT.
IF WE CAN'T IMPLEMENT FOR
EVERYBODY SHOULD WE BE
IMPLEMENTING IT FOR ANYBODY.
>> THAT IS A GREAT POINT, PHIL.
THE DEVELOPMENT AND DESIGN OF
THESE ASSAYS AND FIELD RESEARCH,
RIGHT, WHERE ANDREA WAS SAYING,
COMMUNITIES, ARE -- FALL OUTSIDE
OF THESE ENVIRONMENTS THAT CAN
QUICKLY PROCESS SAMPLES AND SPIN
DOWN PLASMA.
MENT AND THE LIKE.
SO THAT IS A GREAT POINT.
>> LET ME JUST SAY SOME OF THOSE
IMPLEMENTATION ISSUES IS REALLY
SWEET SPOT OF DCCPS SO WE LOOK
FORWARD TO TEAMING WITH THEM
AROUND THOSE IMPLEMENTATION
SCIENCE QUESTIONS.
>> LET'S JUMP TO KAREN.
THEN DEBRA AND ANNA.
AND THEN DAVE TOO IF WE HAVE
TIME.
KIM.
>> DR. CASTLE, THANK YOU FOR A
WONDERFUL PRESENTATION.
I WILL SWITCH GEARS FROM
PREVENTION TO SUPPORTIVE CARE.
I HAVE A COUPLE OF QUESTIONS I
WOULD LOVE TO KNOW YOUR THOUGHTS
AND VISIONS ARE HOW YOU MIGHT
USE THE CLINICAL TRIALS PLANNING
GRANTS IN ORDER TO PREPARE FOR
THESE LARGE CLINICAL TRIALS THAT
WE LAUNCH AND SUPPORTIVE CARE
AND CORE MECHANISM.
TWO OTHER RELATED PIECES.
WHAT IS YOUR VISION OR THOUGHTS
HOW YOU THINK ABOUT RESOURCING
THIS COMMUNITY NCORPS THAT ARE
FUNDED TO ENROLL PATIENTS ON
TRIALS AROUND TWO PARTICULAR
THINGS.
ONE IS HOW YOU LOOK AT FUNDING
AND SUPPORTING THEM TO ENROLL
MORE UNDER-REPRESENTED
MINORITIES ON TO THOSE CLINICAL
TRIALS AT THAT COMMUNITY LEVEL.
THE RESEARCH BASE VERSUS DONE A
GOOD JOB STARTING TO ROLL OUT
STUDY DESIGNS TO DO THIS WORK
BUT THERE IS A HUGE GAP AND HOLE
AT THE NCORP COMMUNITY SITES FOR
THEM TO BE ABLE TO RESOURCE TO
DO THOSE.
SECOND AREA I WOULD BE
INTERESTED TO KNOW ABOUT
RESOURCING IS A LOT OF
SUPPORTIVE CARE IS NOT
PHARMACEUTICAL, THE AGENTS THAT
DO THE MOST RECOMMENDED IN THE
GUIDELINES THAT WE NEED TO SEE
MORE OF THESE LARGE PHASE 3
DEFINITIVE CLINICAL TRIALS ON
ARE LIFESTYLE INTERVENTIONS THAT
INVOLVE EXERCISE NUTRITION,
OTHER TYPES OF LIFESTYLE
BEHAVIORS AND HOW HAVE YOU
THOUGHT ABOUT A EATER USING
SUPPLEMENTS TO EXPEDITE THAT
THROUGH NCORP OR OTHER THINGS OR
RESOURCING THE NCORPS AGAIN AT
THE LEVEL WITH RESOURCES THROUGH
GRANTS THEY NEED TO DO THOSE?
>> WOW.
OKAY.
ALL GOOD QUESTIONS.
I DON'T KNOW THAT I HAVE GOOD
ANSWERS, I MAY HAVE TO COME BACK
TO AND RESPOND MORE DEPTH.
I AGREE OUR ABILITY TO REACH OUT
INTO THE -- REALLY MAKING THESE
THINGS REPRESENTATIVE IS A
CHALLENGE.
WHEN WE -- WHEN I TALK TO FOLKS
WHO WORK IN MAINE AND SAY IT
TAKES FOUR HOURS TO COME TO THE
MAINE CLINIC.
WE ARE NOT REACHING THOSE
PEOPLE, BE HONEST ABOUT THAT.
SO I DON'T KNOW WHAT THE EASY
ANSWER FOR THAT IS.
AND SOME OF THIS HAS TO DO WITH
ISSUES LIKE PERSISTENT POVERTY
WHICH IS SOMETHING DCCPS IS
WORKING ON, THESE ARE AREAS
WHERE YOU HAVE MORALITY THAT
GETS IN THE WAY OF
REPRESENTATION.
SO I DON'T HAVE A GOOD SIMPLE
ANSWER FOR ANY TO BE HONEST.
I WON'T TRY TO PRETEND THAT I
DO.
I THINK WE HAVE ALL STRUGGLED
WITH THEM.
RESOURCES ARE ALWAYS -- WE ARE
ALWAYS STRUGGLING TO HAVE
ENOUGH.
YOUR POINT IS TAKEN.
WE HAVE TO DO BETTER.
I JUST DON'T KNOW HOW TO BE
HONEST WITH YOU.
>> BILL, BY THE WAY, I APOLOGIZE
FOR BEING A LITTLE LATE, I
WOULDN'T MISS FOR THE WORLD
EXCEPT CONGRESS ASKED ME TO
SPEAK TO THEM.
NOW I'M HERE.
THERE WAS A REALLY GOOD QUESTION
ABOUT UNDER-REPRESENTED MINORITY
ACCRUAL AND NCORP REALLY
IMPORTANT TOPIC AND WE SHOULD
HAVE A PRESENTATION ON THAT IN A
FUTURE DAY.
NCI STORY IS GOOD THERE IN SOME
WAYS BUT IT IS COMPLICATED AND
RATHER THAN TRYING TO ANSWER
THAT IN BREVITY TODAY SAVE FOR
FUTURE DISCUSSION BECAUSE IT IS
INTERESTING.
>> I THINK WHARTA WOULD BE
BETTER SUITED TO.
>> TOTALLY AGREE FOR THINGS
RELATED TO NCORP, QUESTIONS AND
COMMENTS.
WE ARE AT 10:40 AND SHOULD BE
JUMPING TO OUR NEXT PRESENTATION
I KNOW THERE WERE A COUPLE OF
HANDS, DEBRA PUT HER QUESTION IN
THE CHAT SO IT WOULD BE GREAT IF
YOU COULD PERUSE CHAT, LOT OF
GREAT COMMENTS THERE.
I KNOW YOU WANT TO SEE THE NEXT
PRESENTATION BUT IF YOU CAN
ADDRESS THOSE IT WOULD BE GREAT.
>> THANK YOU SO MUCH AND THANKS
FOR THE OPPORTUNITY AGAIN.
>> THANK YOU FOR THAT REALLY
TREMENDOUS PRESENTATION.
NEXT PRESENTATION IS ACHIEVING
HEALTH EQUITY THROUGH PREVENTION
AND IMPLEMENTATION SCIENCE OF
PATIENT NAVIGATION AND
UNDERSERVED POPULATIONS THAT
WILL BE PRESENTED PROVIDED TO US
BY DR. MELISSA SIMON, VICE CHAIR
OF RESEARCH DEPARTMENT OF
OBSTETRICS GYNECOLOGY, THE
PROFESSOR CLINICAL GYNECOLOGY
PROFESSOR OBSTETRICS GYNECOLOGY
AND MEDICAL PREVENTION AND
MEDICAL SOCIAL SCIENCES AND
FOUNDING DIRECTOR FOR THE CENTER
OF HEALTH EQUITY TRANSFORMATION
FOUNDING DIRECTOR CHICAGO HEALTH
EQUITY COLLABORATIVE AT
NORTHWESTERN UNIVERSITY FINEBURG
SCHOOL OF MEDICINE AND THE
ROBERT LOUIS COMPREHENSIVE
CANCER CENTER.
MELISSA.
>> THANK YOU FOR HAVING ME,
APPRECIATE IT.
ACTUALLY I HEARD THE LAST
QUESTION AND SOME OF MY WORK AND
WHAT I WILL PRESENT DOVE TAILS
WITH THAT INQUIRY.
NEXT SLIDE PLEASE.
I HAVE NOTHING TO DISCLOSE.
NEXT SLIDE.
ARCHITECTURE AND DESIGN REALLY
MATTER AND SUPPLIES WHETHER YOU
TALK DIVERSITY AND CLINICAL
TRIALS ARE TYPE OF RESEARCH ANY
TYPE OF RESEARCH THAT STRUCTURE
AND WHOLE RESEARCH PROCESS IS
REALLY CRITICAL TO EXAMINE WHEN
YOU ARE TRYING TO HAVE
ANTI-RACISM APPROACHES AND EMBED
HEALTH EQUITY IN EVERY STEP OF
THAT PROCESS IN ORDER TO GET TO
BETTER PATIENT CARE AND OUTCOMES
ESPECIALLY THAT MEET THE
EVOLVING DEMOGRAPHY AND
DEMOGRAPHIC NEEDS OF UNITED
STATES OF AMERICA.
AS YOU ALL KNOW THE BASIC
FORMULA FOR RESEARCH IS REALLY
HAVING SOLID GOOD DATA TO GO
INTO A TRIAL, WELL DESIGNED
TRIAL IN ORDER TO HAVE REALLY
GOOD RESULTS BUT IF YOU DON'T
HAVE REPRESENTATION IN THE
TRIALS AND IN THE STUDIES AND
RESEARCH THEN WHAT ARE THE
RESULTS GOING TO BE APPLICABLE
TO, WHO ARE THEY REALLY GOING TO
APPLY TO.
WE SEE THAT PLAY OUT TIME AND
TIME AGAIN WITH HEALTH
DISPARITIES IN PRETTY MUCH EVERY
SINGLE CANCER IN AMERICA -- IN
THE UNITED STATES OF AMERICA.
SO YOU HAVE TO ASK THE RIGHT
QUESTIONS INVOLVE THE RIGHT
PEOPLE AT TABLE EVERY STEP OF
THE PROCESS AND PATIENT
NAVIGATION AND THAT
IMPLEMENTATION SCIENCE APPROACH
IS REALLY CRITICAL TO INVOLVING
ALL TYPES OF STAKEHOLDERS AT
EVERY STAGE IN THAT RESEARCH
PROCESS.
BECAUSE THEY HELP THE COMMUNITY
AND ALL THE DIFFERENT
STAKEHOLDERS HELP ASK THE RIGHT
QUESTIONS BECAUSE IF YOU DON'T
IS ASK THE RIGHT QUESTIONS AND
INVOLVE THE RIGHT PEOPLE, THEN
THE OUTPUT WILL NOT BE RELEVANT.
SO YOU HAVE TO LOOK UNDER HOOD
OF THE CAR AND SCRUTINIZE THE
RELATED PROCESSES NEXT SLIDE
PLEASE.
REALLY IMPORTANT TO UNDERSTAND
ABOUT THE WORK AND PATIENT
NAVIGATION AND IMPLEMENTATION
SCIENCE ACROSS DIVERSE
POPULATIONS FOR IMPROVED
OUTCOMES.
YOU HAVE TO UNDERSTAND
DEFINITION SO IN EQUALITY
MEANING SOME STRUCTURE, IN THIS
CASE IT IS A TREE STRUCTURE ARE
NOT ORGANIC NECESSARILY, THEY
ARE HUMAN MADE AND HUMAN POSE
BUT POLICY OF PROGRAM AT THIS, A
PROTOCOL DESIGN EXCLUSION OR
INCLUSION OR EXCLUSION CRITERIA
OR SOMETHING THAT IS BENT AND
NOT RIGHT.
BENT AND ACTIVELY FAVORING ONE
PATIENT OR POPULATION AND ACTIVE
DISADVANTAGE IN THE OTHER.
UPPER RIGHT HAND CORNER WHEN YOU
TALK IT IS EQUAL, EQUAL CHANCE
OF PARTICIPATING IN A TRIAL AND
DESIGN THIS PATIENT NAVIGATION
INTERVENTION EQUALLY YOU STILL
IF YOU ARE FUNDAMENTAL
UNDERLYING STRUCTURE IS BENT OR
YOUR PROCESS OR PROTOCOL IS BENT
IN SOME WAY YOU ARE NOT GOING TO
GET EVERYBODY TO REACH THE SAME
OUTCOME OR THE APPLE ON THE
TREE.
THE LOWER LEFT HAND CORNER
EQUITY, USE HEALTH EQUITY AS
WORD AND INVOLVE -- ACKNOWLEDGES
THAT YOU NEED DIFFERENT LISTS
AND DIFFERENT SUPPORTS TO GET
DIVERSE PARTICIPATION AND TRIALS
AND RETENTION AND ACCRUAL EWE
NEED TO HELP PEOPLE OVERCOME
BARRIERS WHICH IS WHAT
NAVIGATORS DO TO HEALTHCARE.
TO GET TO GOOD CANCER OUTCOMES.
IN THE JUSTICE FRAMEWORK IS
WHERE THE IMPLEMENTATION SCIENCE
REALLY LIES AND WHERE HEALTH
EQUITY RESEARCH NCI IS STARTING
TO INVEST IN THIS.
THAT IS ABOUT ASKING THE RIGHT
QUESTION, HAVING THE RIGHT
PEOPLE AT THE TABLE THAT ASK THE
QUESTIONS AS WHY THE DARN TREE
IS BENT IN THE FIRST PLACE, HOW
DO YOU UNBEND THE TREE AND MAKE
SURE THAT THAT LIFT AND THAT
OPPORTUNITY AND RESEARCH PROJECT
AND OUTCOMES ACTUALLY ALLOW
EVERYBODY TO HAVE OPPORTUNITY TO
ACHIEVE THAT OUTCOME.
SOME DETERMINANTS OF HEALTH ARE
BIG PART OF THIS AND THAT IS
NAVIGATION ADDRESSES AND MANY
DIFFERENT WAYS.
BUT IT IS ALSO IMPORTANT TO
ACKNOWLEDGE SOCIAL DETERMINANTS
OF HEALTH AND SOCIAL ECONOMIC
FACTORS THAT ARE DRIVEN BY
SYSTEMIC RACISM AND DRIVEN BY
THOSE TREES THAT ARE BENT AND
STRUCTURE THAT ARE BENT THAT
MAKE THOSE SOCIAL ECONOMIC
FACTORS WORSE AND IMPACT
POTENTIAL PARTICIPANT FROM BEING
ON A TRIAL BUT ALSO ACHIEVING
THE RIGHT CANCER CARE DELIVERY
OR THE SCREENING TEST OR
DIAGNOSTIC RESOLUTION OF
ABNORMAL TEST AND OR ENTRY INTO
REAM IN A TIMELY WAY AND
COMPLETION OF TREATMENT.
NEXT SLIDE.
THE ENTIRE RESEARCH PIPELINE HAS
OPPORTUNITIES WHERE STRUCTURAL
INEQUITIES OR STRUCTURAL RACISM
AND BIAS, THAT STARTS WITH
FUNDER AND DESIGN FUNDING
OPPORTUNITY SO ACKNOWLEDGE IT'S
BONDFUL NCI HAS BEEN --
WONDERFUL NCI IS ADVANCING THE
WAYS IT EMBRACES DEI FOR EXAMPLE
AS A NEW COMPONENT IN THE CCSG,
CANCER CENTER SUPPORT GRANT,
THAT IS CRITICAL TO HELP BEGIN
TO MOVE THE DIVERSE WORK FORCE
FORWARD IN ALL AREAS OF THE
CANCER CENTER AND WITH RESPECT
TO RFA AND EVERYTHING ELSE SO
DESIGN OF THE WHO HOW THE
SCIENTISTS ARE MENTORED WHO GETS
TO BE A SCIENTIST, WHO -- ALL
DESIGN OR STUDY PROTOCOL,
RESEARCH FINDINGS DISSEMINATION
AND IMPACT ALL HAVE
OPPORTUNITIES WHERE THERE'S BIAS
COULD BE UNBENT AND RETHOUGHT,
AGAIN UNDER THE HOOD OF THE CAR.
NEXT SLIDE PLEASE.
SO ANOTHER PART OF THIS PROCESS
IN CANCER CARE DELIVERY WITH
RESPECT TO PATIENT NAVIGATION I
WILL GET TO IN A MINUTE IT IS
IMPORTANT TO UNDERSTAND THAT
EVEN RECOMMENDATION THAT
CLINICIANS, CLINICAL ONCOLOGISTS
ARE TRYING -- PRIMARY CARE
DOCTORS ARE TRYING TO IMPLEMENT
ARE NOT NECESSARILY DEVELOPED
WITH THE RIGHT DATA.
AGAIN, UNDERSTANDING THAT
RECOMMENDATIONS AND THE PROCESS
OF GUIDELINES FOR CLINICAL
ONCOLOGY CARE PRIMARY CARE ARE
REALLY AND SCREENING ARE
CRITICAL.
SO I HAVE BEEN A MEMBER OF THE
UNITED STATES PREVENTIVE
SERVICES FASTOR TASK FORCE TO
HELP TRY TO THINK ABOUT HOW WE
DO THAT BETTER, CREATE
RECOMMENDATIONS THAT ARE MORE
GENERALIZABLE TO THE ACTUAL
EVOLVING DEMOGRAPHY OF OUR
POPULATION.
NEXT SLIDE.
ONE EXAM IS COLORECTAL CANCER
AND REDUCE AGE TO 45.
THE OTHER EXAMPLE IS LUNG CANCER
SCREENING WHERE WE REDUCE THE
PACK YEAR HISTORY.
THOSE ARE CRITICAL BECAUSE THAT
HELPS AVAIL A SCREENING
OPPORTUNITY FOR MORE BLACK
PEOPLE IN OUR COUNTRY.
NEXT SLIDE, THEY ARE THE BRUNT
OF THE CANCER DISPARITIES.
IMPLEMENTATION SCIENCE IS
BRIDGING THE SCIENCE PRACTICE
GAP AND TRYING TO GET MORE
TRANSLATION HAPPENING AT T-4
ACROSS EVERY SINGLE COMMUNITY
HEALTH CENTER AND PRACTICE SITE
ACROSS UNITED STATES.
SO THE CONSOLIDATED FRAMEWORK
FOR IMPLEMENTATION RESEARCH IS
ONE OF MANY IMPLEMENTATION FRAME
WORKS AND REALLY TALKS ABOUT HOW
YOU ARE LOOKING AT THAT PROCESS
OF IMPLEMENTING EVIDENCE BASED
INTERVENTION FROM A TRIAL IN TO
PRACTICE.
IT IS ULTRATIVE AND THERE IS
INTERNAL AND EXTERNAL
ENVIRONMENT AND HOW THEY
INTERACT.
NEXT SLIDE PLEASE.
WHAT IS IMPORTANT ABOUT HOW
PATIENT NAVIGATION WORK WORKS
WITH RESPECT TO HYBRID DESIGN
MEANING LOOKING AT THE PROCESS
OR THE IMPLEMENTATION, WHILE YOU
ARE ATTEMPTING INTERVENTION
ITSELF OR THE PROGRAM, WHATEVER,
THE APPROACH TO SCREENING FOR
CERVICAL CANCER FOR EXAMPLE
ITSELF, THERE IS OPPORTUNITY FOR
AS I HAVE SAID BEFORE,
STRUCTURAL ISSUES, BIAS AND
EVERY PART OF THIS.
PART PLAYS IN THE OUTER ROUND
WHERE I ALREADY SHOWED YOU THE
FRAME W OF SOCIETY AND SOCIO
POLITICAL STRUCTURE AND
ORGANIZATIONAL CULTURE WITHIN
PARTICULAR COMMUNITY HEALTH
CENTER OR PARTICULAR HEALTHCARE
DELIVERY TEAM EXPECTATIONS,
NORMS, INDIVIDUALS INVOLVED THE
PATIENT EXPERIENCE OF
DISCRIMINATION OF DISTRUST AND
EVEN IN THE PROCESS ITSELF SO
REALLY THAT IS WHERE OUR WORK
HAS REALLY TAKEN OFF AND WHERE
WE NEED TO DIVE IN AND EXAMINE
MORE.
NEXT SLIDE EXAMPLE IN SHOG
SHYING, NEXT SLIDE.
IN CHICAGO FOR BREAST CANCER
DISPARITIES, WE HAVE DONE A LOT
OF PATIENT NAVIGATION WORK SINCE
2006 AND PATIENT NAVIGATION
ESPECIALLY BREAST CANCER THROUGH
THE CERVICAL CANCER THROUGH THE
GRACIOUS FUNDING OF NCI
CONTINUOUSLY WITH A VARIETY OF
COMMUNITY AREAS.
AND IN CHICAGO BREAST CANCER
MORTALITY RATES BLACK, WHITE,
DIFFERENT, 62% BY 2007 IN THE
EARLY '80s ON THE LEFT SIDE OF
THAT GRAPH IT WAS APPROXIMATELY
THE SAME.
THAT IS EGREGIOUS AND IT WAS
VERY DIFFERENT THAT 62%
MORTALITY GAP FOR BLACK WOMEN IN
CHICAGO VERSUS WHITE WOMEN IN
BREAST CANCER IS VERY DIFFERENT
THAN THE 27% THAT WAS IN NEW
YORK CITY AT THE SAME TIME OR
THE 40% IN THE UNITED STATES.
NEXT SLIDE.
TAKING THE SOCIAL ECOLOGICAL
MODEL PATIENT NAVIGATION IN
VARIETY OF FORMS AND NOT JUST IN
THE IN PERSON FORM, REALLY
LOOKING AT INTERPERSONAL
BARRIERS, THE MOST INNER CIRCLE
AND REALLY TRYING TO THINK ABOUT
WHAT ARE PROCESSES ACROSS EACH
CLINIC AND EVERY OPPORTUNITY
THAT A WOMAN, A WOMAN OF COLOR
SPECIFICALLY BLACK WOMEN IN
CHICAGO HAD WITH THEIR
MAMMOGRAPHY CENTER, AND WITH
CLINICS AND WE DID AN
ENVIRONMENTAL SCAN WITH SYSTEMS
ENGINEERS FROM BUSINESS SCHOOL
AT NORTHWESTERN TO REALLY FIGURE
OUT WE FOLLOWED WOMEN FROM 27
CLINICS TO FIGURE FROM THE TIME
THEY GOT TO CLINIC EVERY PROCESS
THAT -- AND EVERY SINGLE
INTERACTION WAS DOCUMENTED OF
THIS PATIENT FROM THE TIME THEY
GOT INTO THE TIME THEY LEFT
WITHIN THE MAMMOGRAPHY REFERRAL.
THAT WAS REALLY DIGGING INTO THE
PROCESS AND LOOKING AT
STRUCTURE, WHAT WAS GOING ON AND
WHAT WAS HINGERING.
AND THEN WE ALSO LOOK AT
MAMMOGRAPHY SUITES AND REALIZE
WOMEN WEREN'T GETTING RESULTS OF
MAMMOGRAMS THEY THOUGHT THEY
WERE NORMAL.
SO THESE NEEDED TO BE CORRECTED
THROUGH PATIENT NAVIGATION.
ANOTHER PATIENT NAVIGATION MORE
SYSTEMS LEVEL NEEDED TO HAPPEN
TOO, THE MIDDLE CIRCLES WHICH
WERE IN QUALITY IMPROVEMENT WE
NEEDED TO TEACH AND COACH THEM
AND HELP EVIDENCE BASED
INTERVENTIONS TO FIX FACETS THAT
WERE NOT WORKING WELL FOR WOMEN.
SO THE CORE PRINCIPLES OF
NAVIGATION PATIENT CENTERED
COMMUNITY CENTERED EVIDENCE
BASED IS REALLY TO IMPLEMENTING
DIFFERENT TYPES OF PATIENT
NAVIGATION.
THAT WHAT WAS REALLY CRITICAL IS
BEING ABLE TO STUDY NAVIGATION
AS PHYSICAL NAVIGATORS OR
CHECKLIST AND HOW THOSE WORKED
WITH RESPECT TO OUTCOMES BUT HOW
THAT PHYSICAL PROCESS OF HAVING
A PATIENT NAVIGATOR WITH A
CLINICAL CARE TEAM AND HAVING
CHECKLIST WITH CLINICAL CARE
TEAM IMPROVED PATIENT OUTCOMES
SO STUDYING THE METHOD AND THE
APPROACH AND THE PROCESSES
ITERATIVELY WHILE THE ACTUAL
INTERVENTION ITSELF AND
INTERACTION WITH EACH DIFFERENT
TYPE OF PATIENT WAS REALLY
CRITICAL.
THIS WAS EXAMPLE CHECKLIST WITH
BREAST CANCER, THIS IS A
SEQUENCE CARE SO LOOKS LIKE A
GANT CHART AND HELPING TO EMBED
EQUITY BECAUSE THE PATIENT AND
THE CAREGIVER GOT HARD FORM AND
PATIENT TEAM AND NAVIGATOR SO
EVERYBODY WAS ON THE SAME PAGE
WITH RESPECT TO WHAT WAS NEEDED
TO BE DONE AND APPROXIMATELY
WHAT TIME AND CARE TRAJECTORY,
AND THEN ON THE BACK WE ARE TYPE
OF CONTACT NUMBERS SO TYPE OF
NAVIGATION WITHOUT IN PERSON AND
HELPING GUIDE THE WHOLE TEAM ME
BEYOND THE SAME PAGE WITH SAME
QUALITY CARE CONSISTENTLY ACROSS
EACH PATIENT REGARD OF THE COLOR
OF THE SKIN WHERE THEY ARE FROM,
OR PAYER STATUS.
NAVIGATION PROCESS, ONE OF OUR
STUDIES, IT WAS ABLE THE BRING
RELATIONSHIPSING TO, BUILD
RELATIONSHIPS AND BRING
ORGANIZATIONS TOGETHER WHICH IS
CRITICAL FOR SUBURBAN AREAS IN
COOK COUNTY AND SURROUNDING
BECAUSE NOT ALL PLACES HAVE
PUBLIC HEALTH SAFETY NETS.
WHEN THE YOU DON'T HAVE PUBLIC
HEALTH SAFETY NET URBAN
METROPOLIS PATIENT NAVIGATORS
AND NAVIGATION PROCESS ABLE
BRING RELATIONSHIPS DIFFERENT
COMMUNITY ORGANIZATIONS TOGETHER
THAT WOULD HAVE BEEN WORKING
TOGETHER TO WRAP AROUND IT WASES
NEED AND DETERMINE ECONOMICS
DETERMINANTS OF HEALTH FOR EACH
PATIENT.
ITERATIVE PROCESS, COLLABORATIVE
COLLABORATIVE, WE WERE ABLE TO
CLOSE GAP TO 36% IN 2017 AND
CLOSE A LITTLE MORE.
DURING COVID I CAN'T TELL YOU
WHAT HAPPEN BUT SOON TO SEE BUT
THERE IS STILL WORK TO DO.
IT IS NOT GOOD ENOUGH.
GOOD BUT NOT GOOD ENOUGH.
THIS IS PART OF IT, THANKS THE
NATIONAL CANCER INSTITUTE FOR
FUNDING US UNIVERSITY OF
ILLINOIS CHICAGO, UNIVERSITY OF
ILLINOIS NORTHWESTERN NOW IN #TH
YEAR OF U 54 MECHANISM, IT IS
EXTRAORDINARY WITH RESPECT TO
THE AMOUNT OF RESEARCH,
COMMUNITY COLLABORATION ACROSS
CITY, DIVERSE WORK FORCE
DEVELOPMENT WHICH IS CRITICAL TO
THIS WORK.
HERE IS OUR COMMUNITY
FOOTPRINTS.
WE HAVE THE SHOW TIME ACTRESS
VISIT US THIS YEAR WITH OUR
COMMUNITY FORUMS.
ANOTHER IMPORTANT INITIATIVE THE
PATIENT NAVIGATORS ARE CONNECTED
WITH IS OUR LIBRARY
PARTNERSHIPS, WE PARTNER WITH
CHICAGO PUBLIC LIBRARIES, WE
HAVE A HEALTH FOR ALL PLATFORM
FUNDED BY NATIONAL LIBRARY OF
MEDICINE, SEVERAL GRANTS,
DISPELLING MYTHS ABOUT CLINICAL
TRIAL PARTICIPATION TO HELP
SUPPORT TO MEET NEEDS IN TRUSTED
SPACES.
LIBRARIES AND LIBRARIANS ARE
TRUSTED SPACES AND PROFESSIONALS
IN OUR COUNTRY.
SO YOU HAVE TO GO WHERE THERE IS
TRUST AND GIVE THAT INFORMATION
IN PLACES THAT ARE TRUSTED.
THEN COMMUNITY SCIENTIST, SOME
CALL THEM CITIZEN SCIENTIST, I
DON'T LIKE THE WORD CITIZEN MY
PEOPLE LET CITIZEN IS NOT OUR
PREFERRED WORD SO COMMUNITY
SCIENTIST IS WHAT WE BUILT, WE
HAVE STRONG SET OF COMMUNITY
SCIENTISTS THAT WORK WITH OUR
BENCH SCIENCE TEAMS SO OUR T 0 T
1 AND TO INFLUENCE SCIENCE AND
THAT HELPS BECAUSE THEY ARE LIKE
NAVIGATORS OF THE SORT AND HELP
NAVIGATE RESEARCHERS TO HAVING
BETTER RESEARCH AND ROBUST
PROTOCOLS.
THIS IS ALL CONNECTED.
PATIENT NAVIGATION AN OUTCOMES
AND THE TYPES OF NAVIGATION WE
DO IS ALL CONNECTED.
ANOTHER OPPORTUNITY WE ARE
WORKING ON RIGHT NOW WITH
MULTIPLE BIG TEN SITES ACROSS
THE COUNTRY AND IMPLEMENTATION
SCIENCE AND EVIDENCE BASED
INTERVENTIONS WITH NAVIGATION IS
PART OF IT IS WITH CERVICAL
CANCER MEETING THE NEEDS IN
ORDER TO ADDRESS THE STAGNANT
CERVICAL CANCER RATES IN THIS
COUNTRY WITH DECADES, WE HAVE TO
ADDRESS ALL THREE PILLARS OF THE
WORLD HEALTH ORGANIZATION
CERVICAL CANCER ELIMINATION
STRATEGY, THAT IS WHAT WE ARE
EMBARKING ON NOW.
>> IF YOU CAN BEGIN TO WRAP UP.
>> LAST SLIDE.
FINALLY, IN ORDER TO DO PATIENT
NAVIGATION WORK AN
IMPLEMENTATION SCIENCE YOU NEED
A PIPELINE, DIVERSE SET OF
SCIENTISTS AND I WANT TO THANK
THE NIH FOR THEIR NIH UNITE
INITIATIVE FOR THE FIRST GRANT
INITIATIVE.
THINGS CHANGING CCS DATA AND DEI
COMPONENT TO OPTIMIZE TRAINING
MENTORSHIP CAREER DEVELOPMENT
PATHWAYS FOR DIVERSE
INVESTIGATORS LIKE MYSELF.
THANK YOU.
NEXT SLIDE IS CONTACT
INFORMATION.
>> THANKS, MELISSA.
FANTASTIC.
IF WE CAN GO OUT TO VIEW
PARTICIPANTS WE PROBABLY ONLY
HAVE TIME FOR ONE OR TWO
QUESTIONS, THAT WAS AN EXCELLENT
PRESENTATION WHY DON'T WE START
WITH KAREN AND UNLESS THERE IS
ONE -- LOOKS LIKE TYLER.
WE ARE ONLY GOING TO TAKE TWO
QUESTIONS WE WANT TO STAY ON
TIME.
>> I DIDN'T HAVE A QUESTION I
DIDN'T LOWER MY HAND.
>> I DON'T SEE ANY HANDS BUT I
HAVE A QUESTION.
WHEN I LOOK AT THE NOVEMBER
NAVIGATOR APPROACH, IT IS
FINANCIAL IT SAID CALL YOUR CASE
WORKERS SO SEEMS LIKE THAT
FINANCE PERSONAL PIECE CAN ALSO
BE REALLY IMPORTANT AND WHAT ARE
THOUGHTS EXPANDING THERE?
>> THAT IS ONE VERSION OF THE
FORM.
THERE IS A LOT.
THAT IS COOL GLAD YOU DID
BECAUSEOR BECAUSE FINANCIAL TO
BE TESSIE IS A BIG ISSUE, LOT OF
OUT OF POCKET COSTS WITH
PARTICIPATING IN RESEARCH IN
GENERAL LET ALONE CLINICAL
TRIALS SPECIFICALLY.
PATIENT NAVIGATION A BIG PART OF
WHAT OUR NAVIGATOR TEAMS DO, IS
ADDRESS FINANCIAL ISSUES AND TRY
TO CONNECT PEOPLE TO DIFFERENT
RESOURCES THAT ARE AVAILABLE.
CRITICAL WORK THAT TAKES TIME
BUT UNDERSTANDING HOW
IMPLEMENTED IN DIFFERENT
CLINICAL CARE SETTINGS IS
CRUCIAL AND THAT IS WHY THESE
TYPES OF HYBRID STUDIES OF
NAVIGATION WITH STUDYING THE END
POINTS GET MORE ANTI-RACIST AND
HIGHER EQUITY WHILE ADDRESSING
THE INTERVENTION ITSELF, IT
COSTS MONEY, IT IS MORE THAN A
USUAL RO1 BUDGET.
THAT IS THE CHALLENGE BECAUSE
YOU HAVE TO BE IN SO MANY SITES
TO LOOK AT AND EXAMINE THE
VARIABILITY ACROSS SITES WHILE
EXAMINING THE VARIABILITY OF THE
INTERVENTIONS WITHIN POPULATIONS
AT EACH SITE.
THESE TYPES OF STUDIES REQUIRE
LOTS OF SITES AND HUSBAND MORE
THAN REGULAR RO1 TYPE BUDGET.
>> THANKS.
MELISSA.
I THINK WE ONLY HAVE TIME FOR
WOMB MORE QUESTION OR LEE WE
WILL LOSE TIME DURING THE BREAK.
>> I APOLOGIZE FOR INTERRUPTING
YOU.
OUR SPEAKER IS HAVING ISSUES
JOINING.
SO
>> GREAT.
I WILL START WITH TRAY THEN
ASHE.
>> IN THAT CASE I WILL RERAISE
MY HAND.
I THOUGHT YOUR SLIDE
QUANTITATING OUTCOME DISPARITY
BETWEEN BLACK AND WHITE WOMEN
WAS ABSOLUTELY STUNNING AND
ESPECIALLY SEE IT
QUANTITATIVELY.
I GUESS THE QUESTION IS, BASIC
ONE FOR HOW DO YOU THINK ABOUT
DECON SOLVING COMPLEX WEB OF
FACTORS BETWEEN RACE BETWEEN
CHICAGO GEOGRAPHY SOCIOECONOMIC
STATUS, ALL THESE THINGS CLEARLY
INVOLVE BUT HOW DOES WHEN WE USE
HOW DO YOU THINK ABOUT THAT,
DOES IT MATTER OR DO YOU NEED TO
AND HOW DO YOU DO IT?
>> I DON'T THINK IT MATTERS IN
MANY WAYS BUT WHAT YOU IMMEDIATE
TO KNOW IS BE INFORM.
OR YOU HAVE TO UNDERSTAND THE
DEEP HISTORY OF RACISM AND RED
LINING AND JIM CROW LAWS IN THE
AREAS THAT WE ARE WORKING IN
CHICAGO SOUTH AND WEST SIDES FOR
SURE.
THE HEALTH DISPARITIES
ESPECIALLY IN CANCER MAP OUT TO
THAT RED LINING HISTORY AND ALL
OF THAT YEARS OF DISINVESTMENT
FROM OUR CITY, IT MAPS OUT IN
EVERY SINGLE HEALTH INDICATOR SO
UNDERSTANDING THAT HISTORY AND
BEING MORE PROACTIVE BECAUSE WE
DONE NEED DETAIL DISPARITY WE
NEED TO DO SOMETHING ABOUT IT.
SO SO MOBILIZING IS REALLY
IMPORTANT, WE NEED TO MOBILIZE
MANY ORGANIZATIONS NOT JUST
COMMUNITY ORGANIZATIONS BUT
MOBILIZE MEDIA BECAUSE MEDIA
HELPED PUSH THE OLDER MEN, MAYOR
AND GOVERNOR SAY MAKE THE DATA
GO AWAY, YOU CAN'T WHISK IT AWAY
YOU NEED TO MAKE BETTER POLICIES
AND UNBEND THOSE TREES TO DO A
BETTER JOB OF CARE DELIVERY SO
THE PATIENT NAVIGATION BECAME
MOVER SYSTEM, SYSTEMATIC
APPROACH AND HAVING ON THE
GROUND ONE ON ONE RA TRADITIONAL
DR. HAROLD FRIEDMAN NAVIGATORS
BUT BUILT MORE TO HOW DO YOU
FULFILL THAT BECAUSE IT IS
EXPENSIVE, NAVIGATORS --
INDIVIDUAL NAVIGATORS ARE FUNDED
BY PHILANTHROPIC MEANS OR ALSO
GRANTS.
WHEN THAT FUNDING GOES AWAY HOW
DO YOU CONTINUE THAT WORK WHEN
EVIDENCE BASED INTERVENTION.
TRILLIONS THEY ARE NOT PART OF
THE WORK FORCE SO THOSE ARE THE
CHALLENGES THERE IN PARENT
NAVIGATION WORK SO HOW DO YOU
SCALE IT AND THAT IS WHY WE DID
THE CHECKLIST APPROACH TO TRY TO
-- AND WE ARE STUDYING THAT NOW
WITH MERCK FUNDS AN NCI FUNDS TO
TRY TO FIGURE HOW CAN WE SUSTAIN
NAVIGATION AND DO IT IN MANY
DIFFERENT WAYS.
>> I APOLOGIZE TO EVERYONE, WE
ARE FIVE MINUTES BEHIND.
>> U EMAIL.
>> WE WOULD LIKE NOVEMBER THINGS
ALONG IF POSSIBLE BECAUSE WE
HAVE A BREAK WE NEED TO TAKE.
WE WANT TO MAKE SURE WE HAVE
TIME.
SO BUT PLEASE, PLEASE, PLEASE
TYPE THE QUESTIONS IN THE CHAT.
AND MELISSA YOU CAN PERUSE THE
CHAT AS PHIL DID AND ADDRESS
SOME OF THE QUESTIONS AND
COMMENTS THAT SOME OF THE
COMMITTEE MEMBERS MIGHT HAVE.
AGAIN, I APOLOGIZE BUT WE ARE
RUNNING A LITTLE BIT BEHIND AND
WE WANT TO STAY ON TIME.
THANK YOU.
>> THANK YOU.
>> OUR FINAL PRESENTATION IS
ENTITLED IMPLEMENTING PROGRAM
BASED INTERVENTIONS TO IMPROVE
POPULATION LEVEL LUNG CANCER
OUTCOMES.
THE MID SOUTH MIRACLE.
THIS PRESENTATION WILL BE GIVEN
BY DR. RAYMOND OSAROGIAGBON,
PHYSICIAN BMG BAPTIST CANCER
CENTER AND CHIEF SCIENTIST FOR
THE BAPTIST MEMORIAL HEALTHCARE
SYSTEM.
HE IS ALSO DIRECTOR OF
MULTI-DISCIPLINARY THORACIC
ONCOLOGY PROGRAM AND THORACIC
ONCOLOGY RESEARCH OR OTHER GROUP
AND MEMBER OF THE LONGEVITY
HEALTH EQUITY COUNCIL.
RAYMOND.
>> THANK YOU VERY MUCH, JOHN.
GOOD AFTERNOON OR IS IT GOOD
MORNING, EVERYONE.
THANK YOU FOR INVITATION TO BE
HERE TODAY.
I'M GOING TO TALK TO YOU ABOUT
OUR MID SOUTH MIRACLE.
DO I HAVE CONTROL OF THESE
SLIDES?
>> YES.
>> I WILL JUST SAY NEXT SLIDE.
>> SO MY OBJECTIVES TODAY WILL
BE TO CONTEXTUALIZE MY
HEALTHCARE SYSTEM WITHIN THE
EPIDEMIOLOGY GEOGRAPHIC
EPIDEMIOLOGY OF LUNG CANCER IN
THE UNITED STATES.
AND TAKING POPULATION BENEFIT
PERSPECTIVE, TALK ABOUT
POPULATION IMPACT AND HOW WE
INTEND TO DEPLOY PROGRAMS, SEVEN
SPECIFIC PROGRAMS TO ATTACK
BURDEN THAT IS LUNG CANCER IN
THE MID SOUTH WHAT WE CALL OUR
MID SOUTH NERVE HUB.
MAYBE AT THE END I WILL TALK
ABOUT HOW WE PROPOSE TO MEASURE
THE IMPACT OF THESE EFFORTS.
NEXT SLIDE.
LUNG CANCER, NEXT SLIDE THIS IS
AN ANIMATED SLIDE, WE ARE ALL
EXCITED THAT THE NEWS ABOUT LUNG
CANCER IS GREAT.
ESSENTIALLY YEAR-OVER-YEAR WE
ARE SEEING INCIDENCE AND
MORTALITY FROM LUNG CANCER GOING
DOWN SEQUENTIALLY.
THIS FIRST MAP TELLS YOU THAT
STORY HOE IS NOT UNIFORM.
IN AGGREGATE YES INDEED THE NEWS
IS GREAT BUT LUNG CANCER AS WE
KNOW IS A CANCER OF DISPARITY,
DEEP RED IN THE FIRST MAP OR
STATES WITH HIGHEST PER CAPITA
LUNG CANCER MORTALITY STATISTICS
YOU SEE MOSTLY CLUSTERED IN THE
SOUTHERN MIDWESTERN UNITED
STATES.
SECOND MAP TELLS YOU WHY, THAT
IS THE TOBACCO CONSUMPTION MAP
OF AMERICA AND THIRD MAP SHOWS
YOU THAT AT THE COUNTY LEVEL
STORIES EVEN WORSE.
SO GREEN AND DEEPER GREEN ARE
COUNTIES WHICH YEAR-OVER-YEAR
LUNG CANCER MORTALITY INDEED HAS
BEEN GOING DOWN, RED PINK PURPLE
AND DEEPER RED PINK PURPLE ARE
COUNTIES WHICH THE STORY IS THE
ON SCHISM LUNG CANCER INCIDENCE
MORTALITY STILL GOING UP AND THE
CIRCLE, BLUE CIRCLE SHOWS YOU
THE COUNTIES THAT ARE COVERED BY
MY HEALTHCARE SYSTEM.
SO -- NEXT SLIDE.
THE BAPTIST MEMORIAL HEALTHCARE
CORPORATION IS A NOT FOR PROFIT
HEALTHCARE SYSTEM DEPLOYED
ACROSS THREE STATES AT HEART OF
CANCER MORTALITY BELT OF THE
UNITED STATES, MISSISSIPPI
ARKANSAS TENNESSEE.
BUT OUR POPULATION SPILLS OUT TO
SIX STATES INCLUDING KENTUCKY,
ALABAMA, AND MISSOURI.
STATES WITH SOME OF THE HIGHEST
PER CAPITA LUNG CANCER MORTALITY
STATISTICS SO BAPTIST AS A
SINGLE HEALTHCARE SYSTEM
DEPLOYED ACROSS THREE STATES HAS
12 TO 1300 ANNUAL LUNG CANCER
CASES.
TO PUT THAT IN PERSPECTIVE IN
BAPTIST WHERE A STATE WE WOULD
HAVE MORE LUNG CANCER CASES
EVERY YEAR THAN 12 OF THE 50
UNITED STATES.
ONE OF THE POINTS IS THE
CHALLENGE IS TREMENDOUS AND THE
OPPORTUNITY IS GREAT.
NEXT SLIDE.
HOW DOES ONE TACKLE A WE COULD
PROBLEM AS LUNG CANCER.
THE PUBLIC HEALTH CHAL LENG OF
OUR AGE TAKING POPULATION
PERSPECTIVE IF WE WERE TO DEPLOY
OUR RESOURCES, GREATEST RETURN
ON INVESTMENT, THIS POPULATION
IMPACT TELLS YOU HOW WE GO ABOUT
DOING IT.
WE WOULD DO EVERYTHING WE COULD
TO KEEP PEOPLE FROM SMOKING AND
HELP THOSE WHO DO SMOKE TO QUIT.
WE WOULD DO EVERYTHING WE COULD
TO FIND LUNG CANCER EARLY WHEN
WE COULD BE CURED, WE ARE
EXCITED SCREENING HEALTHY PEOPLE
CERTAIN AGE WITH CERTAIN TOBACCO
HISTORY DOES ALLOW US O CATCH
LUNG CANCER EARLY WITH SCREENING
TEST ONCE A YEAR CT STAMP, THAT
SEEMS NICE BUT ONE OF THE THINGS
WE ALSO DEMONSTRATED IS THAT OF
ALL MANY, MANY MILLIONS OF
IMAGING THAT WE DO FOR MANY
DIFFERENT REASONS EVERY YEAR IF
WE WERE TO PAY PARTICULAR
ATTENTION TO THE ONE THAT SHOW
PRESENCE OF POTENTIAL LIMA LEG
FANTASTIC LESIONS WE COULD ALSO
USE A SORT OF SECOND HARVEST
APPROACH IDENTIFY LUNG CANCER
EARLIER THAT GIVES US RESULTS
THAT ARE VERY SIMILAR TO WHAT WE
GET FROM SCREENING.
SO THIS MANAGEMENT OF INCIDENTAL
DETECTED LUNG NODULES THERE IS
BUSINESS OF LUNG CANCER BEING SO
COMPLICATED THE TREATMENT
DECISION MAKING PROCESS CAN BE
COMPLICATED.
AND OFTEN TIMES LEADS TO BAD
DECISION.
ONE OF THE CHALLENGES IS HOW DO
WE MAKE SURE THE RIGHT PATIENT
GETS RIGHT TREATMENT AT THE
RIGHT TIME.
THOSE WHO ARE FORTUNATE ENOUGH
TO GET THE MAIN TREATMENT WHICH
IS SURGERY, HOW DO WE ENSURE
SURGERY WHEN DONE IS DONE RIGHT
TO GIVE PATIENT THE GREATEST
OPPORTUNITY TO REAP THE BENEFIT
OF EARLY DETECTION.
THERE IS THE CHALLENGE OF ALL
THE OTHER THINGS TO DO WITH THE
PATHOLOGY AND THEN FINALLY THIS
BUSINESS OF GIVING PALLIATIVE
SYSTEMIC THERAPY TO PATIENTS
WITH ADVANCED DISEASE WHICH IS
WHAT MOST ONCOLOGISTS DO.
SO WE HAVE TAKEN THE APPROACH WE
WILL DEPLOY SEVEN SPECIFIC
PROGRAMS HORIZONTALLY AND
VERTICALLY.
VIRTUALLY METROPOLITAN AND
DISSYSTEMNATING THIS
HORIZONTALLY ACROSS THE
HEALTHCARE SYSTEM --
DISSEMINATING.
WE ARE TAKING A RIGOROUS THREE
TIER APPROACH, THAT WE WANT TO
MAKE SURE THAT WE UNDERSTAND THE
POPULATIONS NEEDS USING
POPULATION SCIENCE, WE WANT TO
USE TEAM SCIENCE TO PUT TOGETHER
THE MULTI-DISCIPLINARY TEAM
MEMBERS WHO WILL HELP DEPLOY
THESE PROGRAMS AND WE WANT TO
USE IMPLEMENTATION SCIENCE TO
MAKE SURE THE PROGRAMS GET
MAXIMALLY DEPLOYED IN ALL THE
PLACES WHERE THEY ARE NEEDED SO
NOBODY GETS LEFT BEHIND.
I'M GOING TO GIVE YOU SNAP SHOTS
OF FOUR OF THESE SEVEN PROGRAMS.
FIRST WE WILL TALK SCREENING WE
KNOW LOW DOSE SCREENING CT
SCREENING SAVES LIVES, CHALLENGE
NOW IS CAN YOU DO THIS AT HOME
AND DO IT SAFELY AND
EFFECTIVELY.
WE SEE THAT THERE IS A
TREMENDOUS IMPLEMENTATION
CHALLENGE WITH LOW DOSE CT SCAN,
THIS IS SHOWING YOU AT THE STATE
LEVEL AT LEAST AS RECENTLY AS
2017, 2018, IT IS 3405% ELIGIBLE
PATIENTS WHO HAVE BEEN ABLE TO
GET A SCREENING TEST.
WHAT IS STARTLING IS THAT THE
PLACES WITH HIGHEST PER CAPITA
MORTALITY STATISTICS ARE THE ONE
BEING LEFT BEHIND.
YOU WILL SEE WITHIN THAT CIRCLE
THAT THE STATES IF YOU GO BACK,
PLEASE, ONE STEP THE STATES I
POINTED OUT, ALABAMA TENNESSEE
MISSISSIPPI ARKANSAS WEST
VIRGINIA, THE PLACES WITH SOME
OF THE HIGHEST PER CAPITA LUNG
CANCER MORTALITY STATISTICS WHO
NEED EARLY DETECTION THE MOST
ARE ALSO THE ONES AT THE LOWER
END OF THAT RED LINE AND STATE
OF KENTUCKY IS POSITIVE OUTLIER.
THEY HAVE BEEN ABLE TO FIGURE
SOMETHING OUT.
NEXT SLIDE.
SO THE CHALLENGE THEN IS IF
SCREENING IS DIFFICULT TO DO
WHAT ELSE CAN WE DO BESIDES TRY
TO DEPLOY LOW DOSE SCREENING CT
INFRASTRUCTURE, ONE THING WE
HAVE SHOWN IS IF WE DO THIS
ALGORITHMIC MANAGEMENT OF
INCIDENTALLY DETECTED LUNG
NODULES WE CAN FIND LUNG CANCER
EARLY WHEN WE CAN DO SOMETHING
ABOUT IT SO I'M JUST GOING TO
SHOW YOU REAL QUICK THREE
DIFFERENT PROGRAMS, WITHIN MY
HEALTHCARE SYSTEM.
GREEN IS PATIENTS INTO THE
INCIDENTAL LUNG NODULE PROGRAM,
BLUE ARE PATIENTS MOVE INTO THE
SCREENING PROGRAM AND JUST TO
CONTEXTUALIZE THIS, BLACK
PATIENTS REFER TO OUR
MULTI-DISCIPLINARY THORACIC
PROGRAM SO THE FIRST OF THE
THREE PLOTS SHOWS YOU PERSONS
ENROLLED INTO THE PROGRAM, FOR
EVERY ONE PERSON WE WE HAVE PUT
INTO THE SCREENING PROGRAM WE
HAVE APPROXIMATELY THREE PERSONS
IN THE INCIDENTAL LUNG NODULE
PROGRAM.
THE SECOND PLOT SHOWS YOU
ACCUMULATED NUMBERS OF PERSONS
DIAGNOSED WITH LUNG CANCER LIEU
THESE THREE PROGRAMS AND YOU SEE
AGAIN GREEN, THE NODULE PROGRAM
COMPARED TO BLUE, THE SCREENING
PROGRAM, HERE THE RATIO IS ONE
TO FIVE FOR LUNG CANCER PATIENT
FOLLOWED BY SCREENING WE ARE
FINDING FIVE LUNG CANCER
PATIENTS THROUGH THE NODULE
PROGRAM.
THE THIRD PLOT SHOWS YOU WHAT WE
REALLY WANT TO FIND, WHICH IS
STAGE ONE OR TWO LUNG CANCER AND
YOU CAN SEE ONCE AGAIN THAT
BETWEEN THE BLUE SCREEN PROGRAM
AND GREEN THE NODULE PROGRAM,
THE RELATIONSHIP IS EVEN MORE
SKEWED IN FAVOR OF THE PROGRAM.
SO HOW DO THESE COMPARE IN TERMS
OF CAGE DISTRIBUTION?
THE COLOR CODING IS THE SAME
A. BLUE BEING LOW DOSE CT, GREEN
BEING -- YOU SEE APPROXIMATELY
60% OF PATIENTS DIAGNOSED WITH
LUNG CANCER THROUGH THE TWO
EARLY DETECTION PROGRAMS ONE OR
WHO LUNG CANCER WHICH IS WHAT UP
TO SEE, BUT YOU SIGH IN THE
LOWER BAR RAC NUMBER OF PERSONS
DIAGNOSED WITH EARLY STAGE LUNG
CANCER SIGNIFICANTLY HIGHER
THROUGH THE NODULE PROGRAM THAN
THROUGH THE BLUE.
SCREENING PROGRAM.
THE POINT OF EARLY DETECTION IS
TO BE ABLE TO OFFER PEOPLE
CURATIVE SURGICAL RESECTION SO
THE TWO DIE GRAMS ON THE RIGHT
HAND SIDE, UPPER ONE GIVES YOU
DISTRIBUTION OF PATIENT
DIAGNOSED WITH LUNG CANCER
THROUGH EACH OF THE THREE
PROGRAMS WHO HAD SURGICAL
RESECTION AS SOLE TREATMENT,
THESE ARE EARLIEST OF PATIENTS,
FIRST THREE BARS SHOWS YOU THE
TWO EARLY DETECTION PROGRAMS
DOING ABOUT SAME, THE SECOND
TRIPLET OF BARS INCLUDE PATIENTS
WITH SURGERY IRRESPECTIVE OF ANY
ADDITIONAL TREATMENT THEY HAD TO
GET.
THE THIRD SHOWS PATIENTS WHO HAD
SURGERY AND/OR WHO HAD RADIATION
THERAPY ALSO CURATIVE INTENT.
YOU SEE THE RELATIONSHIP REMAINS
THE SAME.
BUT LOWER BAR GRAPHS SHOW YOU
THE SHEER NUMBER OF PERSONS WE
ARE TALKING ABOUT, THROUGH THE
NODULE PROGRAM SIGNIFICANTLY
HIGHER SEVERAL FOLD HIGHER THAN
THROUGH THE SCREEN PROGRAM.
NEXT SLIDE.
SO WE ALSO DEMONSTRATE THAT
TYPES OF PEOPLE COMING IN
THROUGH THESE PROGRAMS ARE
DIFFERENT SOMEWHAT.
I WILL SHOW THAT.
THE RACIAL DISTRIBUTION OF THE
LUNG CANCER PATIENTS VERY
DIFFERENT.
I REMIND YOU THAT THE NATIONAL
LUNG SCREENING TRIAL MANAGE TO
ENROLL 5% AFRICAN AMERICANS INTO
THAT TRIAL.
WE HAVE FOUND OUT SUBSEQUENTLY,
ACTUALLY SCREENING IS EVEN MORE
BENEFICIAL FOR AFRICAN AMERICANS
THAN OTHER RACES.
THE NUMBERS IN THE CIRCLE SHOW
YOU THE PERCENTAGES OF THE
PEOPLE DIAGNOSED WITH LUNG
CANCER THROUGH THE PROGRAMS I
DEMONSTRATED SO 16% OF THE
SCREEN PATIENTS WITH LUNG CANCER
WERE AFRICAN AMERICAN, IN THE
NODULE PROGRAM ALMOST 30% WHICH
IS SYSTEM TO WHAT WE FIND ACROSS
OUR HEALTH CARE SYSTEM AS A
WHOLE.
NEXT SLIDE.
WE FIND 13% PERSONS DIAGNOSE
WITH LUNG CANCER IN NODULE ARE
PEOPLE WHO NEVER SMOKED, PERSONS
NEVER ELIGIBLE FOR SCREENING I
FIGURING OUT ELIGIBILITY
CRITERIA TO MAKE IT EQUITABLE
FOR EVERYBODY AT RISK.
AND THEN THE LOWER RED CIRCLE
SHOWS YOU THAT THE -- OF THE
PEOPLE WHO QUIT SMOKING THE
MEDIAN QUIT DURATION FOR LUNG
CANCER PATIENTS IS 16 YEARS
MEANING MORE THAN HALF OF THESE
PATIENTS WOULD NOT HAVE BEEN
ELIGIBLE FOR SCREENING BECAUSE
THEY QUIT SMOKING TOO LONG AGO.
COLOR BEING YOU HAD TO BE EITHER
ACTIVE SMOKER OR IF YOU QUIT YOU
HAD TO BE WITHIN15 YEARS.
SO DIFFERENT PATIENTS, WE HAVE
NOW DISSEMINATED THESE PROGRAMS
ACROSS MULTIPLE SITES IN
HEALTHCARE SYSTEM.
AND I WANT TO SHOW YOU AS WE ARE
FLOODING ALL THE OTHER PARTS OF
HEALTHCARE SYSTEM NUMBERS OF
PERSONS DIAGNOSED, WITH LUNG
CANCER GOING UP YOU SEE THE
INFLECTION POINT IN 2020 IN THE
PEAK OF THE PANDEMIC NO LESS THE
NUMBER OF LUNG CANCER PATIENTS
DIAGNOSED THROUGH NODULE IS
RECOGNIZED A A FASTER RATED.
THE RATIO IS NOW ABOUT ONE TO
EIGHT.
ONE LUNG CANCER PATIENT FOUND IN
THE SCREENING PROGRAM, EIGHT
LUNG CANCER PATIENTS IN THE
NODULE PROGRAM.
SO THE GOAL IS TO FIND LUNG
CANCER EARLY.
NOW YOU FOUND THOSE PEOPLE WHO
ARE YOU GOING TO DO?
IDEALLY YOU WANT TO OFFER THEM
CURATIVE INTENT NEXT SLIDE BUT
THIS I WILL DEPRESS YOU A LITTLE
BIT BY SHOWING YOU WORK WE HAVE
DONE DEMONSTRATING THAT PATIENTS
WITH EARLY STAGE LUNG CANCER DO
NOT NECESSARILY GET TREATMENT
THEY NEED.
SO THE PRIMARY RECOMMENDED
TREATMENT OF COURSE IS SURGICAL
RESECTION.
THIS -- THE FIRST DIAGRAM SHOWS
YOU THE STATE LEVEL PROPORTION
OF PERSONS WITH STAGE ONE AND
TWO LUNG CANCER WHO HAVE
SURGICAL RESECTION.
YOU SEE IT IS AS LOWER, ABOUT
50% IN WYOMING, AS HIGH AS 80%
IN UTAH, MASSACHUSETTS AND OTHER
PLACES.
TENNESSEE IN THE MIDDLE,
MISSISSIPPI IS LOWER THAN THAT.
IF YOU LOOK AT THE COUNTY LEVEL
DISPARITY IS EVEN WORSE, RANGING
FROM 13% IN THE LOWER TO 92% IN
THE HIGHEST COUNTIES.
WHAT IS GOING ON COLOR BARS ON
THE RIGHT SIDE SHOW YOU WITHIN A
CERTAIN HEALTHCARE SYSTEM WITH
MA I YOUR HOSPITALS IN DIFFERENT
STATES, HOW THE QUESTION WHAT IS
GOING ON GOT ANSWERED SO EACH
BAR REPRESENTS ALL LUNG CANCER
PATIENTS STAGE ONE OR TWO
DISEASE WITHIN A CERTAIN
HOSPITAL WITHIN THE SAME
HEALTHCARE SYSTEM, WE SEE FIVE
DIFFERENT BARS THERE.
SOD EVERYBODY IDEALLY
RECOMMENDED TREATMENT IS
SURGICAL RESECTION.
THE PROPORTIONS THAT GOT
SURGICAL RESECTION ARE IN THE
BLUE LOWER END OF THE BAR.
YOU CAN SEE HOW DIFFERENT IT IS.
IT IS AS LOW AS 30% IN CERTAIN
HOSPITAL WITHIN THE SAME
HEALTHCARE SYSTEM.
TO HIGHER THAN 60% IN OTHERS.
WHAT IS REALLY DISTURBING IS THE
UPPER BLUE, UPPER MOST BLUE,
PATIENTS WITH TERRIBLE LUNG
CANCER WHO NEVER GOT TREATMENT
BEFORE THEY DIED.
YOU SEE HOW IT IS ALMOST 40% IN
HOSPITAL 3 AND LESS THAN 5% IN
THE MDC.
WHAT IS GOING ON?
>> IF YOU CAN WRAP UP IN TWO
MINUTES.
>> OKAY.
EXCELLENT.
SO WHAT I'M GOING TO SHOW YOU IS
THE RED BARS IN THE OTHER
DIAGRAM SHOWS YOU PATIENTS WHO
NEVER GOT TREATMENT.
AND WHAT THIS TELLS YOU IS THAT
MULTI-DISCIPLINARY CARE,
INTERDISCIPLINARY CARE DECISION
MAKING GIVES YOU BETTER ODDS OF
THE RIGHT TREATMENT AND THAT
TRANSLATES TO SIGNIFICANTLY
BETTER SURVIVAL GREEN
MULTI-CARE, BLUE MET --
METROPOLITAN AND OUR CHALLENGE
NOW IS DISSEMINATE CARE ACROSS
THE HEALTHCARE SYSTEM.
YOU GET PATIENTS EARLY STAGE NOW
YOU WANT TO GIVE SURGICAL
RESECTION, BIGGEST PROBLEM WITH
SURGICAL RESECTION IS MOST OFTEN
DONE FOR YOU SO THE BAR GRAPH
SHOWS YOU LOOKING AT THE SERE
DATABASE, THE PROPORTION OF
PATIENTS WITH NUMBER OF LYMPH
NODES EXAMINED AND JUST SHOWS
YOU THE VAST -- THE MODEL NUMBER
OF EXAMINE AFTER SURGICAL
RESECTION IN THE UNITED STATES
IS ZERO.
THE MOST IMPORTANT INFORMATION
YOU NEED TO MAKE SUBSEQUENT
DECISIONS NOT USUALLY -- 18%
RESECTION.
SO WE HAVE DONE WORK TRYING TO
IMPROVE ON THAT.
RESECTIONS THAT MEET NCCN
GUIDELINES RED IS SURVIVAL,
RESECTIONS THAT FAIL TO DO SO
STICK WITH BLUE THAT IS
SURVIVAL.
BIG DIFFERENCE.
AND WHAT WE SHOW IS THAT IN OUR
HEALTHCARE SYSTEM FROM 2004 TO
2008, 34% RESECTION MAKE NCCN
GUIDELINES WITH INTERVENION
WITH LYMPH NODE KIT WE HAVE BEEN
SEQUENTIALLY ABLE TO IMPROVE
THAT NOT ONLY IN OUR HEALTHCARE
SYSTEM BUT ACROSS EIGHT
DIFFERENT HEALTHCARE SYSTEMS ALL
SYSTEMS WITHIN FIVE CONTIGUOUS
HOSPITAL REGIONS.
I WILL JUST QUICKLY SHOW YOU
THAT THIS KIT IMPROVES PRO,
PROOF PATIENT WHOSE GET NCCN
GUIDELINE COMPLIANCE SURGERY.
THAT MAKES A BIG DIFFERENCE TO
SURVIVAL, UPPER LINE RED
COMPARED TO PATIENTS WITH
SURGERY WITHOUT INTERVENTION,
THE KIT WHICH IS BLUE.
SO WE INTEND TO DO DIFFERENCES
ANALYSIS LOOKING AT THE CASHMAN
AREA POPULATION BASELINE AND
SOMETIME FUTURE LOOKING AT THE
POPULATION LEVEL OUTCOMES OF
LUNG CANCER CARE WITH HYPOTHESIS
WE CAN REDUCE MORTALITY BY
IMPLEMENTING THESE PROGRAMS.
NEXT SLIDE.
MY LAST SLIDE IS MY THANK YOU
SLIDE.
I CERTAINLY WANT TO MAKE SURE I
ACKNOWLEDGE THAT A LOT OF THIS
WORK WAS SUPPORTED BY FUNDING
FROM THE NATIONAL INSTITUTES OF
HEALTH.
THANK YOU.
>> THANKS, WONDERFUL
PRESENTATION AND REALLY
IMPORTANT AREA THAT WE REALLY
NEED TO GET TO.
WE HAVE A REALLY IMPORTANT BREAK
AND I THINK WE NEED TO -- WE
WILL WORK I THINK WITH TO ENSURE
WE LEAVE THAT TIME FOR
DISCUSSION.
>> WE ARE TAKING A BREAK NOW.
SO TAKE A COUPLE OF QUESTIONS.
>> OKAY SO I KNOW OTIS HAD A
QUESTION AND I KNOW MARGARET HAD
A QUESTION AS WELL.
SO I WILL START WITH OTIS.
>> THANK YOU, WONDERFUL
PRESENTATION, ENJOYED IT.
MY QUESTION IS, IT SEEMS TO ME
THERE ARE SOME HOSPITALS THAT
ARE STARTING TO OFFER SPIRAL CT
SCREEN OF THE LUNG THAT IN MY
OPINION MAYBE OUGHT NOT BE
OFFERING BECAUSE THEY DON'T HAVE
THE RESOURCES TO DO SOME OF THE
WORK UP FOR POSITIVES, THEY
DON'T HAVE THE THORACIC SURGEONS
TO DO TREATMENT AND FREQUENTLY
TELL PEOPLE YOU HAVE AN
ABNORMALITY, THIS IS A LIST OF
PLACES YOU SHOULD GO TO.
HAVE YOU SEEN THAT HAPPENING?
>> YEAH SO I THINK THE CHALLENGE
OF LUNG CANCER OF COURSE IS THAT
THOUGH LOW DOSE SCREENING CTs
GIVE YOU THE OPPORTUNITY TO FIND
PATIENTS EARLY AND DO THE RIGHT
THING FOR THAT.
IT IS A NEEDLE IN A HAY STACK
PROBLEM.
GIANT HAY TACK AND THE CHALLENGE
IF WE DID THIS RECKLESSLY WE
WOULD TEAR UP MORE LIVES THAN
SAVE.
SO THE CHALLENGE IS TO PUT
INFRASTRUCTURE TO PUT DOWN
INFRASTRUCTURE IN A WAY THAT YOU
CAN LURE PEOPLE IN, SORT THEM
ACCURATELY, TRIAGE THEM INTO THE
PATHWAYS OF CARE THAT THEY NEED
SO THOSE WHO ARE ENDANGERED GET
RESCUED BY HIGH QUALITY CARE AND
THOSE WHO NEED TO BE LEFT ALONE
GET LEFT ALONE.
THIS IS NOT SOMETHING THAT YOU
CAN EXPECT EVERYBODY TO BE ABLE
TO DO BY BUYING CT SCANNER
PLUGGING IN AND DOING IT.
THAT IS WHY THE TEAM SCIENCE
ASPECT AND IMPLEMENTATION
SCIENCE ASPECT ARE VITALLY
IMPORTANT TO THIS PROJECT.
WHY WE USE RIGOROUS SCIENCE
WITHIN A COMMUNITY BASED
HEALTHCARE SYSTEM YOU CAN'T DO
CT SCANNER AND SAY MEDICARE PAY
FOR IT ALREADY WE START DOING
THIS, YOU HAVE TO HAVE THE HUMAN
RESOURCES TO DO THE RIGHT THING
FOR THE RIGHT PATIENT AT THE
RIGHT TIME.
>> 15 SECONDS, ORIGINAL STUDY
THAT TOLD US THAT LUNG CANCER
SCREENING REDUCES RISK OF DEATH
BY 20% SHOW THAT FOR EVERY 5.4
LIVES SAVED, ONE PERSON DIED
DURING BIOPSY AND WORK UP OF
ABNORMALS SO I JUST KEEP THAT IN
MIND WHAT YOU JUST SAID.
THANK YOU.
>> SO WE HAVE MARGARET THEN
WE'LL HAVE TO MOVE ON.
>> I JUST HAD A SIMPLE QUESTION,
I DIDN'T FULLY UNDERSTAND IT WAS
AN EXCELLENT INTRIGUING
PRESENTATION BY THE WAY.
I DIDN'T FULLY UNDERSTAND THE
THREE GROUPS YOU BEGAN YOUR
PRESENTATION WITH, THE SCREENING
GROUP IS CLEAR, NOT SURE WHAT
YOU MEAN BY NODULE, THEY WERE
SCREENS THEN THE NODULE SO I
DIDN'T UNDERSTAND HOW YOU
DIFFERENTIATED THE TWO AND I
PRESUME THOSE SEEM IN THE
MULTI-DISCIPLINARY CLINIC WERE
SYMPTOMATIC PATIENTS.
RIGHT OR WRONG?
>> YES, THANK YOU,.
GREAT QUESTION.
THE NODULE PATIENTS ARE PEOPLE
WHO HAD RADIOLOGY STUDY FOR
MYRIAD OF REASONS.
WHY WERE WE WERE TRYING TO
RESCUE FROM DYING AVOIDING
INJURIES YOU HAD, IT'S HELPFUL
TO SHOW BY THE WAY THERE IS A
SPOT THERE.
WHAT HAPPENS IS RADIOLOGIST
MENTIONS IT BUT WE ARE SO
DISTRACTED BY HE HAD HEART
ATTACK, MAJOR TRAUMA, WHATEVER,
TAKE CARE OF THAT AND THREE
YEARS LATER DYING OF STAGE 4
LUNG CANCER SO THE NODULE
PROGRAM ACTUALLY IN A VERY
PURPOSEFUL WAY COVERS UP ALL
THESE RADIOLOGY REPORTS USING
KEY WORDS THEN WE HAVE A TEAM OF
NAVIGATORS WHO COME IN BEHIND
AND USING A GUIDELINE, SOCIETY
GUIDELINES, TRIAGE PATIENTS INTO
DIFFERENT -- AND HIGH RISK ONES
GET BENEFIT OF ONGOING
SURVEILLANCE.
THAT'S THE DIFFERENCE BETWEEN
THEM.
>> SEEN IN THE CLINIC
SYMPTOMATIC.
>> WE JUST USE MULTI-DAY COHORT
TO HELP US CONTEXTUALIZE TO
EARLY DETECTION.
THEY ARE CONVENTIONAL PEOPLE
WHOM DAMAGE LUNG CANCER CAME IN.
IT IS BIAS IN ANALYSIS THE
MULTI-DAY COHORT DOES BETTER
THAN AVERAGE PERSON ON THE
STREET WITH LUNG CANCER.
>> SO IF ANYONE HAS ANY
ADDITIONAL QUESTIONS PLEASE TYPE
IN THE CHAT.
RAY, IF YOU CAN PERUSE THE CHAT
AND ADDRESS COMMENTS OR
QUESTIONS, THAT WOULD BE
HELPFUL.
I'M NOW GOING TO PASS THE PODIUM
OVER TO KEITH TO LEAD THE NEXT
SERIES OF DISCUSSIONS AND NEXT
SESSION.
THANK YOU ALL.
>> THANKS, JOHN.
SO WE HAVE TO WORK FOR OUR
BREAK, WE HAVE TWO CONCEPTS TO
GET THROUGH BEFORE WE MAKE IT TO
THE BREAK.
START TO TRAIN US TO USE OUR
TIME EFFICIENTLY, PAULETTE
ENGINEERING AAGENDA YOU ARE GET
CONSULTED ON HIGH LEVEL
DECISIONS LIKE THAT.
REMIND YOU BRIEFLY BSA MEMBERS
STAY CONNECT AND IF YOU WILL
ALSO ON SCREEN THAT WAY WE CAN
COUNT YOUR PRESENCE WHEN WE GET
TO VOTING FOR THOSE THAT ARE
MOTION FOR APPROVAL CONCURRENCE
WE WILL COUNT YOU APPROVING
CONCURRENCE BY SIMPLE PRESENCE
AND COLLECT NO VOTES.
DISAPPROVAL OR NON-CONCURRENCE
VOTES IN THAT CIRCUMSTANCE SO
ONE IMPORTANT POINT AND NCAB
COLLEAGUES REMINDER THAT WE
WELCOME YOUR PARTICIPATION IN
DISCUSSION.
THESE CONCEPTS EVEN THOUGH IT
WILL BE LET'S JUMP IN T. CONCEPT
IS NEW RFA/COOPERATIVE AGREEMENT
PEDIATRIC IMMUNOTHERAPY NETWORK,
DR. SINGH PRESENTING THE
SUBCOMMITTEE IS CHAIRED BY BOB
AND SUPPORTED BY BOB SCHRIBER
AND MYSELF.
UNABLE O JOIN IN PERSON BUT ABLE
TO PARTICIPATE IN THE DISCUSSION
TO PROVIDE FEEDBACK.
WE WILL INITIATE THE DISCUSSION
AFTER DR. SINGH'S PRESENTATION.
TAKE IT AWAY.
>> THANK YOU, DR. FLAHERTY.
GOOD AFTERNOON, EVERYONE.
IT IS MY PLEASURE TO PRESENT THE
PEDIATRIC IMMUNOTHERAPY NETWORK
ON BEHALF OF MY COLLEAGUES FROM
THE DIVISION OF CANCER BIOLOGY
AND CANCER TREATMENT AND
DIAGNOSIS.
NEXT SLIDE PLEASE.
PEDIATRIC CANCER IN
IMMUNOTHERAPY STRATEGIES ARE
VERY DIFFERENT FROM ADULT.
PEDIATRIC CANCER MOSTLY ARISE
FROM MISAPPROPRIATION OF NORMAL
DEVELOPMENT AND PROCESSES.
AND THESE CANCERS TEND TO BE
ORIGIN VERSUS -- CANCERS
EPITHELIAL AND THERE IS YEARS OF
ENVIRONMENTAL EXPOSURE LEADING
TO DNA DAMAGE.
PEDIATRIC CANCER HAVE LESS
EXPOSURE OF THE ENVIRONMENT,
LOOK IN THE FIGURE BELOW THE
MEDIAN MUTATION FOR PEDIATRIC
TUMOR IN THE MAGENTA BAR IS MUCH
LOWER COMPARED TO THE GREEN BAR
FOR ADULT TUMORS.
BECAUSE OF THE LOW MUTATION
BURDEN THERE IS LIMITED SUCCESS
WITH IMMUNE CHECK POINT
INHIBITORS WITH EXCEPTION OF
VERY SMALL SUBSET OF PATIENTS
SHOWN IN THE -- BELOW WHICH ARE
PATIENTS MISMATCH REPAIR
DEFICIENCY.
THESE PATIENTS RESPOND TO IMMUNE
CHECK POINT INHIBITORS.
PEDIATRIC TUMORS HAVE DIFFERENT
IMMUNE INFILTRATES AND
CLASSIFIED THE NODULE CORED
TUMORS SOME EXAMPLES OF
IMMUNOTHERAPIES WHICH HAVE BEEN
SUCCESSFUL TO SOME DEGREE IN
CHILDREN ARE LISTED HERE.
MUCH FEWER COMPARED TO
IMMUNOTHERAPY FOR ADULT
INCLUDING CD 19 TARGETED CAR
T-CELLS, MONOCLONAL ANTIBODIES
FOR GD 2 AND CD 20, ANTIBODY
DRUG CONJUGATES.
AS YOU CAN SEE MOST SUCCESSFUL
ONES IN CHILDREN RELY ON --
COMMUNITY VERSUS THE ONE BY
ENHANCING TUMOR IMMUNOGENICITY
SUCH AS CHECK POINT INHIBITORS.
ANOTHER POINT, OUT OF FIVE
EXAMPLES OF THEM, ONLY ONE
MONOCLONAL ANTIBODY IS INDICATED
SOLID TUMOR INDICATION.
PEDIATRIC SOLID TUMORS REMAIN
AREA OF UNMET CLINICAL NEED AND
THAT'S WHY THIS CONCEPT IS
FOCUSED ON SOLID TUMORS.
FORTUNATELY THERE HAS BEEN SOME
SUCCESSFUL IMMUNOTHERAPY IN
HUMAN MALIGNANCY YOU MAY BE
FAMILIAR WITH ON THE TOP LEFT,
WHO WAS TREATED WITH CD 19 CAR
T-CELLS FOR REFRACTORY AND
RELAPSE LEUKEMIA AND SINCE THEN
MANY MORE CHILDREN TREAT WITH
IMMUNOTHERAPY ESPECIALLY WORKING
MALIGNANCIES AS YOU CAN SEE THE
TOP RIGHT.
UNFORTUNATELY SIMILAR SUCCESS
NOT ACHIEVED FOR SOLID BRAIN
TUMORS, IF YOU LOOK AT THE EVENT
FREE SURVIVAL IN THE BOTTOM
RIGHT HIGH RISK NEUROBLASTOMA
STILL IN THE RANGE 40 TO 06% AND
FOR BRAIN TUMORS LIKE DIPG LESS
THAN TWO YEARS FROM THE TIME OF
INITIAL DIAGNOSIS.
PEDIATRIC SOLID BRAIN TUMORS
HAVE UNIQUE CHALLENGES.
TUMORS ARE RARE TUMORS BUT DOES
POSE ADDITIONAL CHALLENGE FOR
CLINICIANS AND INVESTIGATORS
STUDY BECAUSE THERE ARE LIMITED
PATIENTS FOR ANY GIVEN TUMOR
INDICATION TO FOLLOW.
SPECIMEN AVAILABILITY IS
LIMITED, THERE ARE ADDITIONAL
CONSIDERATIONS ON AMOUNT AND
FREQUENCY OF SPECIMEN COLLECTION
AND LONGITUDINAL SAMPLING COULD
BE A PROBLEM.
MONITORING RESPONSE TO THERAPY
CAN GET VERY CHALLENGING, FOR
INSTANCE IMAGING WHO NEED
ANESTHETIZE PATIENTS THEY DON'T
UNDERSTAND HOW DEVELOPING IMMUNE
SYSTEM IN CHILDREN AFFECT THEIR
RESPONSE FOR RESISTANCE TO
IMMUNE THERAPIES.
THE TUMOR MICROENVIRONMENT IS
VERY POORLY UNDERSTOOD,
ESPECIALLY FOR BRAIN TUMORS.
I ALLUDED TO THE MUTATION BURDEN
AND THESE BEING IMMUNOCORED
TUMORS BECAUSE OF BODIES OF KIDS
ARE GROWING THERE IS INCREASE
FOR THERAPEUTIC TOXICITY
INCLUDING NEUROTOXICITY FOR
DEVELOPING BRAIN.
SIMILAR TOP ADULT THERE IS LACK
OF APPROPRIATE MODEL SYSTEMS,
YOU HAVE TO CONSIDER TUMOR
HETEROGENEITY, BLOOD BRAIN
BARRIER FOR BRAIN TUMORS AND
LACK OF NON-TUMOR TARGETS.
NEXT SLIDE PLEASE.
WE RECENTLY PERFORMED A
PORTFOLIO ANALYSIS FOR GRANTS IN
PEDIATRIC SOLID TUMOR
IMMUNOTHERAPY AND THERE ARE ONLY
31 GRANTS IN THIS AREA.
WE DO REALIZE THERE IS A NEED TO
INCREASE BOTH IN THE
PRE-CLINICAL AS WELL AS CLINICAL
SPACE RECENTLY PUBLISHED AN RFI
REQUEST FOR INFORMATION TOGETHER
IN PUT FROM THE RESEARCH
COMMUNITY.
RECEIVED A VERY GOOD RESPONSE,
SEVERAL OPPORTUNITIES WERE
IDENTIFIED WHERE NCI COULD HELP.
SOME OF THE TOPICS ARE LISTED
HERE.
A NEED FOR TARGETED ANGIOGENIC
ANECDOTES BINDERS AND
IMMUNOTHERAPY AGENTS,
ELUCIDATION OF IMMUNE INVASION
MECHANISMS, PEDIATRIC
PRE-CLINICAL MODEL ESPECIALLY
BRAIN TUMORS, RESOURCES FOR
DEVELOPING PROTEIN THERAPEUTICS
IND STUDIES AND CPMG
MANUFACTURING.
PREDICTIVE BIOMARKERS ANALYTICAL
TECHNOLOGIES FOR IMMUNE
MONITORING AND OPPORTUNITIES FOR
REVERSE TRANSLATION.
SO IN RESPONSE TO THE INPUT FROM
THE RFI, AS WELL AS INPUT FROM
THE NCI WE ARE PROPOSING THIS
NEW NETWORK CALLED PEDIATRIC
IMMUNOTHERAPY NETWORK.
THE PURPOSE OF WHICH WILL BE TO
DEVELOP TRANSLATABLE NOVEL
IMMUNOTHERAPY APPROACHES FOR
CHILDREN AND ADULTS WITH SOLID
TUMORS INCLUDING BRAIN TUMORS.
THE FOCUS OF PIN AS YOU CAN SEE
IN THE DIAGRAM WILL BE FROM
BASIC RESEARCH, LEADING TO
DISCOVERY VALIDATION
PRE-CLINICAL ALL WAY UP TO
CLINICAL TRIALS.
AND REVERSE TRANSLATION STUDIES
IN WHICH YOU CAN TAKE CLINICAL
SPECIMENS BACK TO LAB TO DO
BASIC PRE-CLINICAL AND
CONFIRMATORY STUDIES WILL ALSO
BE PART OF PIN.
NEXT SLIDE PLEASE.
THE SLIDE LISTS EXAMPLES OF
PROJECTS WHICH COULD BE PART OF
PIN DISCOVERY OF NOVEL ANTIGENS,
AND ANALYSIS OF PEDIATRIC
SPECIFIC IMMUNE RESPONSE, IMMUNE
PROFILING OF SOLID TUMORS,
STRATEGIES TO MODULATE PEDIATRIC
TUMOR MICROENVIRONMENT,
DEVELOPMENT TESTING AND
OPTIMIZATION OF PRE-CLINICAL
AGENTS, AND DIVERSE TRANSLATION
STUDIES USED IN CLINICAL
SPECIMENS TO INTERROGATE
MECHANISMS OF ACTION OR
RESISTANCE TO IMMUNE THERAPY.
SLIDE SHOWS PROPOSED -- WE
ANTICIPATE 6 TO 8 UO 1 AWARDS
STEERING COMMITTEE WILL CONSIST
OF INVESTIGATORS OF THESE U 1
PROJECTS AND NCI STAFF, PATIENT
ADVOCATES AND ADDITIONAL FUNDED
RESEARCHERS WILL BE EVIDENCE
ASSOCIATED MEMBERS AND
ADMINISTRATIVE COORDINATION WILL
BE PROVIDED BY ONE OF THE UO 1
SITES IN PARTNERSHIP WITH THE
NCI.
NEXT SLIDE PLEASE.
THIS SLIDE SHOWS HOW PIN CAN
INTERACT WITH OTHER
COMPLIMENTARY PEDIATRIC CANCER
NETWORKS AT THAT TIME NCI.
NCI HAS A WIDE SPECTRUM OF
PEDIATRIC PROGRAMS SUCH AS PIN
CAN BENEFIT AND INTERACT WITH
DATA INITIATIVES LIKE THE
CHILDHOOD CANCER INITIATIVE CCD
ISH.
MOON SHOT INITIATED PROGRAMS
SUCH AS FUSION ONCO PROTEIN AS
DRIVERS FOR CHILDHOOD CANCER,
ANOTHER MOON SHOT PROGRAM DIDDA,
FOCUSED ON IMMUNOTHERAPY.
NATURAL HISTORY STUDIES LIKE --
AGENTS CAN UNDERGO TESTING AND
PRE-CLINICAL TESTING PROGRAMS
LIKE THE PIVOT PROGRAM.
AGENTS DISCOVERED IN PIN CAN
ADVANCE INTO CLINICAL TRIALS
THROUGH THESE SUCH AS CHILDREN'S
ONCOLOGY GROUP, BLASTOMA, BRAIN
TUMOR CONSORTIUM AND THE EARLY
PHASE CLINICAL TRIAL NETWORK.
INVESTIGATORS FROM PIN CAN ALSO
APPLY TO THE NEXT PROGRAM OR USE
OTHER NCI RESOURCES.
THIS SLIDE SHOWS COMPARISON OF
PIN WITH CURRENT MOON SHOT
INITIATIVE DIDDN.
AS DR. SINGH MENTIONED IN HER
TALK YESTERDAY, PIN IS BUILDING
UPON THE ACCOMPLISHMENTS OF THE
IDDA GIVEN UNMET CLINICAL NEED,
THE FOCUS OF PIN WILL BE
RESTRICTED TO SOLID TUMORS
INCLUDING BRAIN TUMORS, THERE
WILL BE ENHANCE FOCUS ON
TRANSLATION IN ADDITION TO
DISCOVERY AND DEVELOPMENT AND
THE EARLIEST ANTICIPATED START
DATE IS SEPTEMBER 2023.
NEXT SLIDE PLEASE.
WE ANTICIPATE SIX TO EIGHT UO 1
AWARDS WITH EACH AWARD TO BE
AROUND 765 TOTAL COST WE DO
REQUEST MONEY FOR ADMINISTRATIVE
SUPPLEMENTS AND NETWORK SUPPORT
WITH A TOTAL NETWORK COST FOR
FIVE YEARS TO BE 30 MILLION.
NEXT SLIDE PLEASE.
WE NEED AN RFA MECHANISM, THIS
IS AN AREA UPON SCIENTIFIC AND
CLINICAL NEED.
THERE ARE ONLY 31 GRANTS IN THIS
AREA.
CURRENTLY THERE'S NO SPECIALIZED
PEER REVIEW IN A SINGLE RECEIPT
DATE ALLOW FOR FUNDING OFF THE
NETWORK.
WE NEED A MECHANISM NCI STAFF
PARTICIPATE IN STEERING
COMMITTEE MEETINGS, WE ARE OPEN
TO DISCUSS CURRENT CHALLENGES,
PROVIDE OVERALL ADVICE AND
DIRECTION.
AND FOSTER COLLABORATION.
AND THERE WILL BE FUNDS
AVAILABLE TO ENHANCE
INTRANETWORK COLLABORATION.
NCI STAFF EDUCATE STEERING
COMMITTEE MEMBERS OF USE OF NCI
RESOURCES AS WELL AS OTHER
PEDIATRIC PROGRAMS.
THE SLIDE LISTS THE CRITERIA
WHICH CAN BE USED TO JUDGE
SUCCESS OF PIN AND FIVE YEAR
AGREEMENT THESE MAY INCLUDE
DISCOVERY DEVELOPMENT AND
VALIDATION OF NOVEL TARGETS,
PRE-CLINICAL TESTING AND
DEVELOPMENT OF SINGLE OR
COMBINATION OF AGENTS, NOVEL
MECHANISTIC INSIGHT INTO THE
TUMOR MICROENVIRONMENT RESPONSE
OR RESISTANCE, CONDUCTIVE IND
ENABLING STUDIES AND PROMOTION
OF NOVEL AGENTS INTO A PILOT
CLINICAL TRIAL.
THE DATA WOULD LIKE -- WITH THAT
LISTENING AND SPECIAL THANKS TO
THE SUBCOMMITTEE MEMBERS DR.
FLAHERTY, AND WE HAVE INCLUDED
THEIR COMMENTS IN THE SLIDES
PRESENT.
WITH THAT I WILL BE HAPPY TO
TAKE QUESTIONS.
>> GREAT.
THANK YOU.
BOB WOULD YOU LIKE TO GET US
STARTD?
>> THANK YOU, DR. FLAHERTY AND
SINGH, THANK YOU FOR THAT
PRESENTATION.
I WOULD SAY QUITE SIMPLY THE
ONLY COMMENT FROM THE
SUBCOMMITTEE YOU DIDN'T INCLUDE
WAS THAT WE THOUGHT THIS WAS
ABSOLUTELY WONDERFUL AND IT'S
WELL CONCEIVE AND WELL EXECUTED.
SO I WILL JUST ECHO A FEW
THINGS.
THIS IS DIFFERENT BIOLOGY.
AND SCIENTIFIC CONSIDERATION,
MADE THAT HAVE CLEAR.
THE PORTFOLIO TO NCI IS HER 2
MAMMAL.
THIS LEVERAGES WHERE MOON SHOT
HAS TAKEN US PARTICULARLY FROM
DISCOVER INTO CLINIC.
SO THIS IS -- THAT SLIDE
COMPARING THE DIDN TO ME IS THE
MOST IMPORTANT SLIDE, CONSENSUS
DRIVEN DATA DRIVEN 6 TO 8 UO
1s WITH NCI AND UO 1 TEAMS
ORGANIZING THEMSELVES LEVERAGING
NATIONAL PEDIATRIC GROUPS WITH
SUCCESS METRICS, WHAT MORE COULD
YOU ASK, WE SUPPORT THE U RFA AS
PROPOSED, I WILL LET KEITH ADD
HIS THOUGHTS.
>> JUST TO EMPHASIZE THE POINT I
THINK WE ARE ALL PERFECTLY WELL
AWARE OF, THIS IS AG AREA WHERE
EXTERNAL ACTIVITY EXTERNAL TO
NCI IS UNDERINVESTED IN.
THAT IS TRUE SO MUCH OF
PEDIATRIC ONCOLOGY BUT CERTAINLY
WHAT IS UNIQUE IMMUNOTHERAPY
STRATEGIES FOR THE PEDIATRIC
POPULATION SO AREA OF O UNMET
NEED THAT IS UNDERATTENDED TO.
AND MAYBE JUST UNDERSCORE POINT
ABOUT THE MECHANISM AND
APPROACH, I THINK THIS IS A
MODEL THAT WORKED WELL IN RECENT
YEARS AT NCI IN TERMS OF
COORDINATING THIS NETWORK OF UO
1s, ALLOWING NCI LEADERSHIP TO
BE CENTRALLY INVOLVED SO I THINK
THAT METHOD IS VERY WELL TESTED
IN ONCOLOGY AND I THINK IS VERY
APT FOR THIS PROPOSAL AS WELL.
OTHERWISE NOTHING ELSE TO ADD.
HAM PI TO TAKE OTHER QUESTIONS
OR COMMENTS FROM BSA OR NCAB
MEMBERS.
HAPPY.
>> I JUST PUT A COMMENT QUESTION
IN THE CHAT JUST TO HIGHLIGHT WE
HAVE SUCH A -- WE HAVE A LONG
WAY TO GO WITH OUR FUNDING LINE
SO I HOPE UO 1s WOULDEN
COURAGE OR WON'T SAY REQUIRE,
BUT NEW INVESTIGATOR YOUNG
INVESTIGATORS IS I THINK WE NEED
TO EMPHASIZE SUPPORTING THEM.
>> THANK YOU FOR THE COMMENT.
YES.
>> VERY EXCITE #-D TO SEE THIS,
IT IS A DESPERATELY NEEDED
INITIATIVE.
SO WONDERING IF THERE WILL BE
SPECIFIC SELECTION OF THE COMP
MEN TARTY OF PROJECTS
REPRESENTED -- COMPLIMENTARITY
IN THE CLUSTER OF UO 1s OR
JUST TAKING THE STRONGEST UO 1,
ARE YOU LOOKING FOR PARTICUAR
THEMES YOU OUTLINE NUMBER OF
THEMES THAT WOULD BE ADDRESSED
BY DIFFERENT ONES.
AND ALSO HOW THE COORDINATING
CENTER WILL ACTIVELY FACILITATE
EXCHANGE OF REAGENTS PERHAPS
ACROSS DIFFERENT GROUPS
PARTICULARLY MODEL SYSTEMS WHICH
ARE REALLY CRITICAL FOR PROPER
STUDIES TO BE CONDUCTED.
>> THANK YOU, DR. BAKER.
GREAT QUESTION.
SO IN TERMS OF THE PROJECT WHICH
WILL BE CONSIDERED, APPLICATIONS
HAVE TO BE MERITORIOUS, NAY WILL
UNDERGO A THOROUGH REVIEW
PROCESS.
IN TERMS OF PREPARING THE
FUNDING PLAN WE WILL LOOK AT OUR
PROGRAM PORTFOLIO OF GRANTS
WHICH IS ALREADY FUNDED AND
WHERE THE GAPS ARE.
THERE WILL BE CONSIDERATION AND
NCI STAFF WILL WORK BASED ON
REVIEWS AND EVERYTHING.
IN TERMS OF THE COORDINATION, WE
ARE REQUESTING ADMINISTRATIVE
COORDINATION LIKE MOST SLEEPER
MEETING SUPPORT AND OTHER THINGS
BUT THERE WILL BE A STEERING
COMMITTEE BASED ON WHICH WILL BE
BY THE NCI STAFF AS WELL AS
INVESTIGATORS FROM THESE UO 1
SITES, THOSE WILL BE ACTIVELY
INVOLVED FOR INSTANCE MAKING
SURE FACILITATING ACCESS TO
RESOURCES OR PREVIOUS EXPERIENCE
WITH THE IDDN, ALL THE
INVESTIGATORS, REALLY WORK VERY
WELL IN THESE SORTS OF NETWORK.
AND THEY ARE VERY HAPPY TO
COLLABORATE.
THOSE INTERNETWORK
COLLABORATIONS WITH SUPPLEMENTS
FUNDS REALLY HELP TO ENHANCE
COLLABORATION EVEN FURTHER.
IN TERMS OF KNOWLEDGE ABOUT
OTHER PROGRAMS, NCS STAFF IS
HAPPY TO PROVIDE MORE
INFORMATION IF APPLICATION TO
THE NEXT PROGRAM OR EARLY PHASE
CLINICAL TRIALS, SO WEAPON A
BROAD TEAM OF EXPERTISE ON THIS.
>> JOHN.
>> THANK YOU.
I KNOW SOMETIMES IT IS DIFFICULT
AND WE THINK ABOUT SORT OF THE
CONCEPT OF INTEGRATION WE THINK
ABOUT ADULT RISK PEDIATRIC
BECAUSE WE KNOW THOSE THINGS CAN
BE VERY DIFFERENT BUT THINK
LARGE NETWORKS WITH STRONG FOCUS
ON BIOLOGY AND UNDERSTANDING OF
IMMUNOTHERAPEUTICS, ARE THERE --
IS THERE ANY INTEGRATION WITH
ANYTHING GOING ON ON THE ADULT
SIDE?
RIGHT NOW WE HAVE NOT BUT I CAN
GIVE AN EXAMPLE OF PREVIOUS
BECAUSE WE ARE PLANNING WHAT
GOES ON AT THE IOTN WHICH IS A
BIG NETWORK -- WHICH IS A VERY
BIG MOON SHOT INITIATED NETWORK
ON THE ADULT SIDE.
IN THE PAST TO GIVE AN EXAMPLE,
WE HOPE TO BUILD UPON A SIMILAR
COLLABORATION LIKE WE JUST HAD
OUR ENROLL MEETING WHICH WAS A
MEETING BETWEEN DIDDN
INVESTIGATORS IOTN K-9 FOR
PANCREATIC CANCER.
SO THERE IS A LOT OF SCIENTIFIC
EXCHANGE.
AND COLLABORATION BETWEEN ADULT
AND PEDIATRIC SO WITH THE
CURRENT FUNDED NIDDN AND ITTN
THERE'S FUTURE PROGRAMS IN ADULT
SIDE AND WE DO HOPE TO CONNECT
WITH THEM AND WE HAVE SEEN VERY
FRUITFUL COLLABORATION IN THE
PAST AND HOPE TO CONTINUE THAT.
>> MIGHT I ADD THE DIFFERENCES
ARE A LITTLE MORE STRAIGHT
FORWARD FOR SMALL MOLECULE AND
ANTIBODIES, FOR CELLULAR
IMMUNOTHERAPY IT IS HARDER.
THIS IS AREA NCI GIVE AS LOT OF
THOUGHT AND SPACE FOR US TO DO
MORE SO WE HAVE BEEN WORKING
THROUGH THOSE ISSUES OF
COORDINATION WITH ADULTS AND
CHILDREN AROUND CELLULAR
IMMUNOTHERAPY, PARTICULARLY
SUCCESSFUL TO DATE, WHERE THERE
IS REAL FUTURE OPPORTUNITY.
>> THANKS ALL FOR THE EXCELLENT
QUESTIONS.
LET'S MOVE TO VOTING.
BOB WOULD YOU MAKE A MOTION?
>> MOVE TO APPROVE 6789
>> I WILL STAND ASIDE FOR A
SECOND AND ASK ANOTHER BSA
MEMBER TO SECOND.
>> I WILL SECOND.
>> THANK YOU.
ANY FURTHER DISCUSSION?
SO VERY GOOD.
MOTION ON THE TABLE TO APPROVE
ONLY LOOKING FOR DISAPPROVALS SO
PLEASE VOICE THAT OR RAISE YOUR
HAND.
OR BOTH BSA MEMBERS ONLY.
SEEING NO HANDS, PAULETTE AND
ANY ABSTENTIONS?
NOD UNANIMOUS APPROVAL NO
ABSTENTIONS.
PAULETTE.
WE ARE MOVING ON TO THE SECOND
CONCEPT OF THE DAY.
THIS IS A NEW RFA INTEGRATE
HEALTH DISPARITIES INTO
IMMUNOONCOLOGY RESEARCH.
DR. WILLIAM KUO IS PRESENTING
AND SUBCOMMITTEE CHAIRED BY --
AND SUPPORTED BY BOB VONDERHYDE.
PLEASE GO AHEAD.
>> THIS CONCEPT ON INTEGRATING
HEALTH DISPARITIES INTO
IMMUNO-ONCOLOGY RESEARCH IS A
JOINT PROGRAM BETWEEN THE
DIVISION OF CANCER BIOLOGY AND
CENTER TO REDUCE CANCER HEALTH
DISPARITIES.
WITH CRITICAL INPUTS FROM
TIFFANY WALLACE AND NELSON.
WE THANKS DR.S SPRAWLY AND VON
DER HYDREA FLECKED IN THIS
CONSENT.
OUTSTANDING CANCER GAPS AND
HEALTH DISPARITIES ARE EVIDENT
IN MULTI-LAYERED IMPEDIMENTS AND
ACCESS TO CARE AND SIGNIFICANT
DRIVERS CONTRIBUTING TO HEALTH
DISPARITIES.
INTERDISCIPLINARY RESEARCH AND
IMPLEMENTATION SCIENCE GAPS
INCLUDE RACISM SOCIOECONOMIC
STATUS AND GEOGRAPHIC ORIGIN.
DESPITE RECENT ADVANCES IN
IMMUNO-ONCOLOGY HERE IN REFERRED
TO IO TUMOR IMMUNOLOGY, HEALTH
DISPARITIES PERSIST AND NEED TO
BE ADDRESSED IN THE IRB RESEARCH
ECOSYSTEM.
IT IS IMPERATIVE TO TAP THESE
MULTI-LAYER PROBLEMS THROUGH
COMPLIMENTARY BASIC RESEARCH
FOCUSED AT THE INTERSECTION
BETWEEN HEALTH DISPARITIES AND
IO RESEARCH.
IN ADDITION TO ACCESS TO CARE
AND IMPLEMENTATION SCIENCE GAPS
THERE IS A CRITICAL NEED FOR
COMPLIMENTARY BASIC SCIENCE
RESEARCH.
FROM THE DIVISION OF CANCER
BIOLOGY PERSPECTIVES, BASIC
SCIENCE CHALLENGES AND CANCER
HEALTH DISPARITIES INCLUDE
COMPLEX AND OVERLAPPING
BIOLOGICAL IMMUNOLOGICAL FACTORS
IMPACTING DISPARITY.
DIFFICULTY OR DIFFICULT TO
ACCESS SUFFICIENTLY POWERED OR
WELL CURATED SPECIMENS, LOWER
NUMBERS OF UNDER-REPRESENTED
GROUPS RECRUITED TO CLINICAL
TRIALS.
THUS THE B 6 SCIENCE OBJECTIVES
INTEGRATE HEALTH DISPARITIES
THROUGHOUT THE NCI IO RESEARCH
CONTINUUM.
WE ACKNOWLEDGE THIS IS A
MULTI-FACETTED RESEARCH GAP AND
WE ARE STARTING WITH BASIC
SCIENCE. SHOWN HERE ARE
EXAMPLES OF RESEARCH GAPS AT THE
INTERSECTION OF HEALTH
DISPARITIES AND IO.
UNDERSTANDING INFLAMMATORY
METABOLIC IMMUNE PROFILES OF
IMMUNOTHERAPY TREATMENT AND
RESPONSE ACROSS
UNDER-REPRESENTED POPULATIONS,
INVESTIGATING GENETIC IMMUNE
SIGNATURES INFILTRATES AND
DISTINCT TUMOR IMMUNE
MICROENVIRONMENTS THAT MAY
UNDERLIE -- THAT MAY CONTRIBUTE
TO CANCER HEALTH DISPARITIES.
SHOWN HERE ARE MOM OR SPECIFIC
SPECIFIC GRANULAR RESEARCH
EXAMPLES CHARGE RISING UNIQUE OR
IMMUNE INFILTRATE PROFILES
ACROSS AFRICAN AMERICAN AND
CAUCASIAN PATIENTS.
UNDERSTANDING HOW DISTINCT
GENETIC AND IMMUNE SIGNATURES IN
THE TUMOR MICROENVIRONMENT ARE
ASSOCIATED WITH COLON CANCER
DISPARITIES.
DEVELOPING ANIMAL MODEL THAT
RECAPITULATE THE BREADTH OF
IMMUNE RESPONSES ACROSS
UNDER-REPRESENTED POPULATION AND
CHARACTERIZING DISPARITIES IN
IMMUNOTHERAPY RESPONSE
RESISTANCE AND IMMUNE RELATED
ADVERSE EVENTS.
WITH REPRODUCIBILITY WE STARTED
BY LOOKING A THE NCI PORTFOLIO
LOOKING AT PO 1 AS AN EXAMPLE OF
MULTI-DISCIPLINARY PROJECTS.
AND AS OUR PO 1 BEING SUBMIT
WITH HEALTH DISPARITIES AND
IMMUNOTHERAPY.
FROM FY 2017 TO 2021, 333
INVESTIGATOR INITIATED UO 1
APPLICATIONS WERE SUBMITTED.
18% APPLICATIONS SUBMITTED SHOWN
IN THE GREEN SLICE WERE FOCUSED
ON IMMUNOTHERAPY OR
IMMUNO-ONCOLOGY.
UNFORTUNATELY NONE OF THESE HAD
A HEALTH DISPARITIES COMPONENT.
ON THE FLIP SIDE, THE 1.5
PERCENT APPLICATIONS SUBMITTED
FOCUSED ON HEALTH DISPARITIES,
NONE OF THESE HAD IMMUNOLOGY
COMPONENT.
SO THESE DATA SUGGEST THAT THERE
IS A POTENTIAL POOL OF
APPLICANTS REFOCUSED TO FULLY
INTEGRATE HEALTH DISPARITIES TO
IMMUNO-ONCOLOGY RESEARCH.
SO THIS PORTFOLIO ANALYSIS
INDICATES THERE IS POTENTIAL
APPLICANT POOL FOR STUDYING
HEALTH DISPARITIES IN IO.
HOWEVER MULTI-DISCIPLINARY THAT
INCORPORATE HEALTH DISPARITIES
RESEARCH REMAIN UNMET NEED.
PROGRAM PROPOSE FOLLOWING
SOLUTION, TACKLING COMPLEXITIES
REQUIRES A MULTI-PRONG
PROGRAMMATIC APPROACH TO
INTEGRATE HEALTH DISPARITIES
INTO IO RESEARCH.
FIRST ONGOING BASIC
TRANSLATIONAL RESEARCH PROJECT
SUPPORTED THROUGH THE NCI AND
SECOND FOCUS OF THIS CONCEPT TO
SUPPORT FEASIBILITY AND PLANNING
PROJECT TO STUDY -- STRENGTHEN
STUDIES FROM MULTI-DISCIPLINARY
PROJECT SUCH AS PO 1.
NEXT SLIDE PLEASE.
SO THE AS SEPARATIONAL GOAL IS
TO BUILD A COHORT OF IO PO 1s
WITH INTEGRATED HEALTH
DISPARITIES RESEARCH.
THIS IS A HIGH BAR IN PO 1
INTEGRATION TRACK RECORD OF
COLLABORATIONS AND PUBLICATIONS.
SO SUCCESSFUL MULTI-DISCIPLINARY
RESEARCH WILL REQUIRE
FOUNDATIONAL FEASIBILITY
PROJECTS.
THIS CAN BE DONE THROUGH
SUPPORTING ONGOING PROGRAMS OR
NOTICE OF SPECIAL INTEREST, THIS
IS NOT ENOUGH.
IN THE NEXT SLIDE WE WILL
PROPOSE P 20s WRITE ARE
FEASIBILITY PLANNING STUDIES TO
BUILD COLLABORATION APPROPRIATE
SAMPLE SETS GENERATE PRELIMINARY
DATA FOR SUBSEQUENT APPLICATION
SUB MISSION.
SO WHAT ARE P 20s?
GRANTS TO SUPPORT PLANNING OR
FEASIBILITY STUDIES TO INTEGRATE
HEALTH DISPARITIES INTO MULTI-DI
PLENARY IO RESEARCH STUDIES.
IT IS EXPECTED PRELIMINARY
STUDIES FROM THE P 20 TO ENABLE
DEVELOPMENT OF INVESTIGATOR
INITIATED MULTI-DISCIPLINARY
PROJECTS SUCH AS PO 1
MULTI-DISCIPLINARY RO1.
RESEARCH SPOKE MAY INCLUDE
INITIAL STUDIES, TO ESTABLISH
SUFFICIENTLY POWERED OR WELL
CURATIVE SPECIMENS FROM GROUPS
UNDER-REPRESENTED IN CLINICAL
TRIALS, FEASIBILITY OR PILOT
STUDIES TO TEST EXPLORATORY OR
NOVEL HYPOTHESES ON IMMUNE
MECHANISMS, IMMUNE RESPONSE OR
TREATMENT RESPONSE RESISTANCE
THAT MAY CONTRIBUTE TO HELP
CANCER HEALTH DISPARITIES.
RESEARCH MAY ALSO INCLUDE
PLANNING STUDIES TO BUILD
COLLABORATIVE TEAMS GENERATE
RESOURCES SUCH AS TOOLS AND
REAGENTS AND COLLABORATIVE
RESEARCH INFRASTRUCTURE.
NEXT SLIDE.
FOR THE P 20 THE SPECIFIC
REQUIREMENT ARE THE INTEGRATION
OF UNDERSERVED POPULATIONS.
THIS IS AND EXPANDED SCOPE AND
RESPONSE TO THE BSA REVIEW
RECOMMENDATIONS TO BE INCLUSIVE
OF SOCIOECONOMIC STATUS AND
GEOGRAPHIC ORIGIN.
THE OTHER REQUIREMENT FOR THESE
P 20s IS THEY SHOULD BE
MULTI-DI PLENARY TEAMS WITH
COMPLIMENTARY EXPERTISE WITH
CANCER DISPARITIES AND IO
RESEARCH.
WE ARE REQUESTING A MODEST
BUDGET FOR TWO YEARS CAPPED
250,000-DOLLAR DIRECT COSTS PER
YEAR.
SO $1 MILLION TOTAL COST FOR
YEAR ONE.
AS JUSTIFICATION FOR RFA THERE
IS NO NIH P 20 PARENT
ANNOUNCEMENT AND IMPORTANTLY AS
AN RFA WILL ENABLE US TO HAVE
SPECIFIC REQUIREMENTS FOR
RESPONSIVENESS DESCRIBED ABOVE
AND SPECIFIC REVIEW CRITERIA.
THE IMPETUS FOR THESE P 20 IS
BUILT -- THE IMPETUS FOR THIS IS
BUILT ON THE SPORES P 20 AS A
MODEL.
NEXT SLIDE.
CRITICAL TO SUCCESS FOR THE P 20
SCIENTIFIC OUTREACH PROGRAM
COORDINATION THIS IS
PRE-APPLICATION OUTREACH TO BOTH
HEALTH DISPARITIES AND
IMMUNO-ONCOLOGY RESEARCH
COMMUNITIES SUCH AS AACR AND
PROGRAM COORDINATION BETWEEN CRC
AND DBCB STAFF.
FOR EVALUATION CRITERIA, METRICS
OF SUCCESS WE HOPE TO SEE
ESTABLISHMENT OF COMPLIMENTARY
MULTI-DISCIPLINARY RESEARCH
TEAMS WITH STRENGTH CANCER
HEALTH DISPARITIES AND IO
RESEARCH PRE-APPLICATION OR
SUBMISSION OF WELL INTEGRATED
MULTI-DISCIPLINARY RESEARCH
PROJECTS SUCH AS PO 1 OR RO1, IF
THE P 20 TEAM IS DEVELOPING AN
INVESTIGATOR INITIATED PROGRAM
PROJECT OR PO 1 HAS P 20 TEAM
FORMED ADVISORY BOARD TO REVIEW
INITIAL PO 1 SUBMISSION.
I WILL TRACK PUBLICATION AND
METRICS OF COLLABORATION.
NEXT SLIDE.
SO WE THINK DR.S SPRAWLEY AND
VON DEER HYDE FOR THE CRAW CRITICAL
REVIEW OF THIS PROJECT.
HEALTH DISPARITIES ARE ROOTED IN
ACCESS TO CARE FACTORS AND NOT
UNDERLYING BIOLOGY.
WE AGREE ACCESS TO CARE AND
QUALITY OF TREATMENT ARE
PARAMOUNT PROBLEMS TO BE
ADDRESSD BY THE BROADER RESEARCH
COMMUNITY.
WE ACKNOWLEDGE RACISM CAN LEAD
TO BIOLOGICAL EFFECT THAT CAN
LEAD TO HEALTH DISPARITIES.
AND SIMPLY IMMUNOLOGIC RESPONSES
MAY VARY BASED ON ENVIRONMENTAL
INFLUENCES INCLUDING RACISM
SOCIO POLITICAL FACTORS POVERTY
MAL NUTRITION AND GEOGRAPHIC
ORIGIN.
TAKING THESE FACTORS INTO
CONSIDERATION, THE SCOPE OF THE
P 20 PILOT PROGRAM EXTENDS
BEYOND ACCESS FACTORS ALONE AND
DESIGNED TO COMPLIMENTARILY HELP
BY BIOLOGY IMMUNOLOGY INTERACT
WITH COMPLEX INTERRELATED
CONTRIBUTORS TO IO RELATED
DISPARITIES.
SECOND, ACCESS TO CARE RACISM
SOCIOECONOMIC GEOGRAPHIC CAN BE
ADDRESSED.
THIS P 25 PROGRAM WILL ELICIT
COMPLIMENTARY MULTI-DISCIPLINARY
RESEARCH TEAMS TO ADDRESS THESE
MULTI-LAYERED PROGRAMS.
THE P 20 ALSO ENABLES
FEASIBILITY AND PILOT STUDIES TO
ENABLE EXPLORATION OF NOVEL HIGH
RISK HYPOTHESES AND THUS ENABLE
STUDIES AT THE INTERSEXUALITY OF
THESE MULTIPLE COMPONENTS.
THE NEXT SLIDE IS THE LAST
SLIDE.
I WILL PAUSE AND WELCOME
DISCUSSION.
>> THANK YOU VERY MUCH.
>> I WANT TO THANK DR. COOL AND
DR. HOULIHAN.
YOU GUYS REALLY DID LISTEN TO
US.
I APPRECIATE THAT.
I HAD SOME INITIAL CONCERNS
ABOUT THE EXCLUSION OF SOCIALLY
DEPRIVED POPULATIONS OR LITTLE
BIT SOUNDED MORE LIKE RACE WAS
NOT A SOCIO POLITICAL CAT
FORRIZATION BUT BIOLOGICAL
CATEGORIZATION, BUT THE TEAM
TOOK THOSE AND WENT BACK AND
REDID THINGS.
I LOVE THIS.
I THINK IT IS GREAT.
I FULLY ENDORSE IT.
DR. VON DEER HYDE AND DR.
DAVENY, HOW DO YOU FEEL?
>> I AGREE THIS IS VASTLY
IMPROVED.
AND APPRECIATE YOUR INTEGRATING
COMMENTS AND GIVEN TIGHT TIME
LINE THAT YOU HAD TO WORK WITH.
I DO HAVE A COUPLE OF QUESTIONS
MAYBE PERHAPS ONE MORE LIKE IN A
CONCEPT ITSELF IS ENORMOUSLY
IMPORTANT BUT I THINK I STRUGGLE
WITH WHAT IS AN UNDERLYING
PREMISE BEHIND IT, ONE, BUT ALSO
IS YOUR IDEA TO FOCUS THIS ON
EFFECTIVENESS IMMUNOTHERAPY OR
IS IT ABOUT IMPLEMENTING
ADDITIONAL IMMUNOTHERAPY?
I THINK THOSE ARE DIFFERENCES
AND WE TALKED ALSO ABOUT I LIKE
FOR YOUR TEAM TO MAYBE TALK A
LITTLE BIT ABOUT WHETHER THIS IS
HEALTH DISPARITIES RESEARCH
GENERICALLY OR YOU HAVE
POPULATIONS OF FOCUS IN MIND.
BECAUSE I DO THINK WHEN WE THROW
TO CAP IT OUT, -- THROW THE
CARPET OUT WE MAY CATCH FLIES
FROM DIFFERENT PLACES IF WE TRY
TO FOCUS MORE NARROWLY, KNOWING
WE HAVE A BIG PROBLEM OUT THERE,
I THINK IT WILL GIVE US BETTER
CHANCE OF KNOWING IF PROGRAM WE
HAVE UNDERTAKEN IS EFFECTIVE.
BUT I DO THINK THE QUESTION
WHETHER IT IS AN EFFECTIVENESS
ISSUE THIS IS TRYING TO ADDRESS
AND I GUESS INCLUSIVENESS ISSUE
IMPLEMENTATION ISSUE BUT THIS
NEEDS TO BE A LITTLE CLEARER FOR
YOU TO BE ABLE TO VOUCH FOR
SUCCESS OF THIS INITIATIVE.
SO I SHARE ENTHUSIASM BUT I
STILL HAVE SOME QUESTIONS THAT
ILY WILL BE IMPORTANT TO
CONSIDER.
>> SURE.
THOSE ARE GREAT COMMENTS AND WE
WILL CERTAINLY TAKE IT INTO
CONSIDERATION.
I THINK IN GENERAL, WE WANT TO
BE INCLUSIVE OF ALL THESE
FACTORS.
WE ARE NOT BEING TOO
PRESCRIPTIVE AT THIS POINT IN
TERMS OF LOOKING AT TREATMENT
OUTCOMES.
WE CERTAINLY -- BASED ON PRIOR
PROGRAMS, WE -- IMMUNO-ONCOLOGY
LANDS SCAPE, WE ARE INTERESTED
IN BOTH PREVENTION AND TREATMENT
AND SO I THINK WE ARE WILLING TO
CONSIDER EVERYTHING.
THAT -- IMMUNE FACTORS OR
FACTORS THAT IMPACT
IMMUNO-ONCOLOGY P
>> THIS IS A -- THIS WAS NOT A
STRAIGHT FORWARD DISCUSSION.
THERE IS A LOT PACKED IN HERE.
SO THE NOTION OF UNDERSTANDING
INTERSECTION I THINK WE LIKE
USING A -- FOR PEOPLE TO START
GETTING TOOLS TOGETHER AND TEAMS
TOGETHER MAKES SENSE.
I DON'T KNOW WHAT YOU ARE GOING
TO GET.
NOT SURE WE -- THIS IS A LITTLE
BIT LIKE WIDE OPEN.
SO I THINK -- RAISED THIS ISSUE.
MAYBE THAT IS THE POINT TO SORT
OF -- LET THE EXTRAMURAL
COMMUNITY BE INNOVATIVE AND
CREATIVE TOGETHER WITH NOVEL
TEAMS AND START ASKING KEY
QUESTIONS.
I DON'T KNOW WHAT ANGLE PEOPLE
WILL TAKE.
NOT SURE NECESSARILY GOING TO
TAKE BIOLOGICAL ANGLE OR
SOCIOECONOMIC ANGLE, I DON'T
KNOW.
MAYBE WE THINK THAT IS OKAY.
BUT WE DON'T KNOW TWO A FEW
THINGS LIKE WHAT IS THE RESPONSE
TO CHECK POINT THERAPY FOR
PATIENTS WITH METASTATIC LUNG
CANCER IF BLACK OR WHITE OR
HISPANIC, ALL OTHER THINGS BEING
EQUAL.
IF WE KNEW THAT, STUDY THAT OR
DO WE NEED TO STUDY THAT.
I'M OKAY WITH GETTING GOING, AS
OTIS SAID BUT I JUST THINK WE
NEED TO KEEP AN EYE ON
SHARPENING A LENS HERE AND
KNOWING WHAT THIS -- WHAT YOU
ARE REALLY TRYING TO OBTAIN.
A LITTLE BIT LIKE/GOOD BUT, BUT.
>> THAT IS ABSOLUTELY FAIR, THAT
IS WHY THIS IS A PILOT PROGRAM.
WE LEAVE TO INVESTIGATOR BASED
ON STRENGTH AND THEIR RESEARCH
AND THE COLLABORATIVE TEAMS THEY
CAN PUT TOGETHER.
ED TO PUT FORWARD TWO YEAR PILOT
PROJECTS IN TERMS OF NARROWING
IT IS A GOAL DESCRIBED OF HAVING
LARGER MULTI-DISCIPLINARY
RESEARCH PROJECTS AND HOW THEY
GET THERE.
SO IT IS FIRST STEP BUT WE SOME
POINT WANT TO FOCUS THE RESERGE.
>> THIS IS THE SMALLEST PROPOSAL
IN OUR DISCUSSIONS YESTERDAY TO
TODAY.
SO JUST TO BE LEER CLEAR IT IS
TOE IN THE WATER RELATIVELY
SPEAKING.
YOUR LANDSCAPE ANALYSIS MAKES A
POWERFUL POINT.
YOU DON'T KNOW WHAT YOU GET
BECAUSE THERE IS NO FUNDING IN
THIS AREA RIGHT NOW.
SOD CHALLENGING TO KNOW WHAT THE
PROFILE PATTERN WOULD BE, JOHN,
ANDREW, THE TWO OF YOU.
MOTIONING AND VOTING JOHN.
>> COUPLE OF POINTS.
I'M HIGHLY ENTHUSIASTIC.
ONLY THING NOT ENTHUSIASTIC
ABOUT IS HOW LITTLE MONEY
REQUESTED.
>> SO MANY HYPOTHESES THAT ARE
THAT HAVE DRIVEN BIOMEDICAL
RESEARCH, DRIVING TODAY CREATED
BACK IN THE '80s AND '90s.
SOMEONE HAD AN IDEA, SOMEONE HAD
A QUESTION AND WITHOUT HAVING AN
OPPORTUNITY TO ASK THE QUESTION
AND ANSWER IT, WE WOULDN'T BE
FOLLOWING UP ON A LOT OF THE
WORK THAT'S LEADING AND GUIDING
US TODAY IN BIOMEDICAL RESEARCH.
WITHOUT A DOUBT WE HAVE TO HAVE
THE OPPORTUNITY TO EXPLORE SO
MANY GAPS IN THIS AREA PRESENTED
AT ASCO AND WRITTEN UP IN ACR
CONFERENCES WITH IMMUNO-ONCOLOGY
DRIVING CANCER THERAPY TODAY.
KNOWING SO LITTLE ABOUT THE
SIMILARITIES AND THE
DIFFERENCES.
SO I'M HIGHLY ENTHUSIASTIC ABOUT
THESE TYPES OF EXPLORATORY
APPROACHES TO BEGIN TO ADDRESS
THESE ISSUES.
I ALSO THINK WE HAVE TO BE
CAREFUL, I TOLDLY AGREE
FOUNDATION OF DISPARITIES ARE
SOCIOECONOMIC AND SOCIAL BUT IT
IS NOT THE ONLY THING.
THEIR DISPARITIES BOTH IN
INCIDENCE AND RISK AND OUTCOMES.
THERE IS A STRONG BIOLOGICAL
FACTOR TO DISPARITY ASSOCIATED
WITH RISK AND PREVALENCE BUT
DISPARITY IN OUTCOMES COULD BE
ALSO ECONOMICS AND VICE VERSA.
SO I THINK WE HAVE TO BE CAREFUL
SOMETIMES WHEN WE JUST SAY IT IS
ALL ONE THING AND JUST SOLVE
THIS ONE THING WE SOLVE ALL
PROBLEMS.
THESE ARE MULTI-FACTORAL ISSUES
THE ONLY THING I WOULD SUGGEST
LILLIAN IS THAT WHEN YOU ARE
DEVELOPING EVERY RFA OR -- HAS
DESCRIPTIONS OF THESE ARE THE
TYPES OF PROPOSALS WE ARE
LOOKING FOR.
THEY ARE USUALLY A SERIES OF
BULLETS.
YOU CAN BEGIN TO GUIDE POTENTIAL
APPLICANTS TO THE TYPE OF GRANTS
AND PROGRAMS YOU ARE LOOKING FOR
TO BE DEVELOPED SO WE CAN
ADDRESS SOME OF THOSE ISSUES
AROUND WHAT ARE WE GOING TO GET
BY PROVIDING LEAST SOME GUIDANCE
IN THE ANNOUNCEMENT TO POTENTIAL
APPLICANTS.
BUT I THINK THAT IT IS LONG
OVERDUE AND REALLY EXCITED ABOUT
THIS.
>> CORRECT ME IF I'M WRONG.
YOU PUT THE GEOGRAPHIC ORIGIN
PHRASE IN THERE.
TO ANSWER JOHN'S FIRST POINT HOW
IT'S NOT JUST SOCIOECONOMIC --
MOVE FROM RACE AND AREA OF
GEOGRAPHIC ORIGIN.
>> WE DON'T WANT THROW BABY OUT
WITH BAST WATER, THERE COULD BE
ISSUES RELATIVE TO STRUCTURE
BUILT ENVIRONMENT THAT IMPACT
PHYSIOLOGY AND BIOLOGY SO YOU
HAVE TO CONSIDER BOTH CONCEPTS,
RACE AS WELL AS GEOGRAPHIC
ORIGIN.
>> IF I MAY, I THINK JOHN YOU
YOU MAKE IT IMPORTANT TO POINT
ABOUT BIOLOGY BUT EVERY TIME
THAT WORK COMES UP IT SEEMS TO
TRIGGER SOMETHING IMMEDIATE THAT
FORCES ME TO RESPOND.
IT IS IMPORTANT FOR US TO BE
CLEAR THERE ARE NOT REAL
BIOLOGICAL DIFFERENCE THAT DRIVE
DISPARITIES.
IN
>> I TOTALLY DISAGREE.
>> YOU CAN DISAGREE BUT THERE
ARE DIFFERENCE IN GENETICS BUT
BIOLOGICAL DIFFERENCES ARE
DRIVEN BY ENVIRONMENTAL
EXPOSURES AND ADVERSE SECOND
SENSES.
THOSE WE CAN AGREE ON, BUT WHEN
WE TALK BIOLOGY, --
>> GENETICS IS BIOLOGY.
THAT'S MY ONLY POINT.
(OVERLAPPING SPEAKERS)
>> LET'S MOVE ON.
>> ANDREW, I JUST WANT TO SAY I
THINK THIS IS THE -- YOU ARE
GOING TO OPEN THERE'S SO MUCH
INTEREST TO INFORMATION, THAT IT
IS GOING TO COME OUT OF THIS
BECAUSE WE KNOW IN EVERY DAY
PRACTICE THAT WE TREAT THE SAME
WITH THE SAME DIAGNOSIS SAME
CHEMOTHERAPY AND I CAN TELL YOU
THAT THERE ARE MANY AFRICAN
AMERICAN HISPANC PATIENTS ARE
NOT RESPONDING TO THE SAME
TREATMENT THAT I GIVE FOR ONE
DISEASE AT THE SAME TIME.
WE ALSO KNOW THAT BLACK PATIENTS
BLACK THAT HAVE NOT -- FOR
EXAMPLE AS MA ASTHMA, THEY DON'T HAVE
THE SAME RECEPTORS TO RESPOND TO
AL BEAUTY ROLL SO WE ARE
LEARNING THERE ARE BIOLOGICAL
DIFFERENCES RELATED TO THE
CONTINENT THAT YOU WERE BORN IN
AND THE ENVIRONMENT OF THAT
CONTINENT.
SO I THINK WE ARE
UNDERESTIMATING A LITTLE BIT
SAYING MAY NOT BE BIOLOGICAL,
MAY NOT FIND ANYTHING, U THINK
YOU FIND A TON ONCE YOU START
LOOKING.
AND I JUST THINK WE REALLY --
THE COMMENT MAY NOT BE ENOUGH
MONEY WE ARE GOING TO FUND NOT
GOING TO BE ENOUGH MONEY BECAUSE
THERE WILL BE INTERESTING
PROPOSALS BASED ON GETTING THIS
INFORMATION.
IT IS BIOLOGIC.
SOME OF IT IS SOCIOECONOMIC BUT
A LOT OF IT IS BIOLOGIC.
>> IT IS UNDERFUNDED, IT IS
FASCINATING.
LET'S TAKE IT AWAY FROM RACE.
SOCIAL DETERMINANTS OF HEALTH
DETERMINE YOUR MICROBIOME, YOUR
MICROBIOME TERMS YOUR RESPONSE.
WE NEED MORE WORK IN THIS AREA.
WE DON'T HAVE TO TALK ABOUT
UNDER-REPRESENTED.
I THINK THE WAY OTIS REFRAMED
IT, IN TERMS OF SOCIAL
DETERMINANTS OF HEALTH AND
IMMUNO-ONCOLOGY, THIS IS WORTH
INVESTING IN.
>> AGREED AND IN FUTURE
CONVERSATIONS WE CAN DISCUSS
ABOUT HOW MUCH MORE INVESTMENT
THERE SHOULD BE IN THIS AREA.
THERE'S CONSENSUS THERE.
CAN I ASK FOR A MOTION?
>> I WOULD LIKE TO MAKE A MOTION
WE ACCEPT THIS -- A
RECOMMENDATION THAT WE ACCEPT
THIS, IF IT IS POSSIBLE I ALSO
LOU I CAN TO MAKE A
RECOMMENDATION PERHAPS THE NCI
WOULD COME BACK TO THIS BODY IN
TWO OR LEE YEARS WITH AN UPDATE.
>> GREAT.
I HEAR THAT AS APPROVAL.
>> AGAIN (OVERLAPPING SPEAKERS)
(OVERLAPPING SPEAKERS)
>> CAN I GET A SECOND?
>> OTIS CAN YOU CLARIFY WHAT YOU
MEAN UP DAY, REPORT WHAT HAPPENS
WITH THE P 20 MECHANISM?
>> YES.
>> VERY GOOD.
-- SECONDED THAT, ANY FURTHER
DISCUSSION?
THIS IS A NEW CONCEPT SO
APPROVAL IS WHAT -- IS THE
MOTION ON THE TABLE.
ONLY COLLECTING BSA MEMBER
DISAPPROVALS IF THERE ARE ANY
PLEASE VOICE OR RAISE YOUR HAND.
I SEE NONE, PAULETTE.
ANY ABSTENTIONS?
SO UNANIMOUS APPROVAL NO
ABSTENTIONS.
PAULETTE.
WE GO TO BREAK.
GREAT.
OKAY.
SO STAY ON YOUR SCREENS, PLEASE,
BSA NCAB MEMBERS.
BUT WE WILL NOW ENTER THE BREAK.
>> KEITH, TOGETHER TO GIVE
RETURN TIME.
20 MINUTES.
>> 2:35.
>> RESUME THE CONCEPT REVIEW, WE
HAVE A THIRD CON REISSUE RFA.
DATA RESOURCE FOR ANALYZING
SUPPORTING BLOOD AND MARROW
TRANSPLANTS.
AND CELLULAR IMMUNOTHERAPY
RESEARCH.
BE PRESENTED BY DR. LORI
HENDERSON, SUBCOMMITTEE IS
CHAIRED BY MIKE DEISICH AND BOB
SCHREIBER, WHO ALSO COULDN'T
JOIN TODAY.
LORI GO AHEAD WITH YOUR
PRESENTATION.
>> THANK YOU FOR GIVING THE
OPPORTUNITY TO PRESENT THIS
CONCEPT.
WHICH SEEKS TO REISSUE THE
LIMITED COMPETITION RFA.
THAT RENEWS CENTER FOR
INTERNATIONAL BLOOD AND MARROW
TRANSPLANT RESEARCH REGISTRY
WHICH IS MORE COMMONLY KNOWN AS
CRDNTR, IT IS DATA RESOURCE
ANALYZE BLOOD SUPPORTS BONE
MARROW TRANSPLANT CELLULAR
THERAPY RESEARCH.
NEXT SLIDE, PLEASE.
THE CMDR IS FUNDED BY NCI MORE
THAN 30 YEARS WITH SUPPORT FROM
HEART LUNG AND BLOOD AND ALLERGY
INFECTIOUS DISEASE INSTITUTE IT
HAS BECOME A WORLD LEADING
RESOURCE THAT CAPTURES THE
INFORMATION OF HE MAN POIETIC
STEM CELL TRANSPLANT AND
ADOPTIVE CELL THERAPIES,
SPECIFICALLY WITH REGARDS TO US.
IT IS ESSENTIAL FOR RESEARCHERS
CLINICIANS AROUND FARM SUIT CELL
COMPANIES THAT HAVE TO MEET
ONGOING HHS PROGRAMS, SUCH AS
THE STEM CELL THERAPEUTIC
OUTCOMES DATABASE WHICH IS
MANAGED BY HRSA AND THE LONG
TERM FOLLOW-UP STUDIES AND CAR
T-CELL PRODUCTS WHICH IS
REQUIRED BY THE FDA AS WELL AS
THE EVIDENCE DEVELOPMENT
INITIATIVES FOR INSURANCE COVERS
BY C, MANYS THE NETWORK ALSO
CONDUCTS STUDIES AND WHICH
INFORMS CLINICAL TRIALS AND
PRACTICE, THAT ARE ASSOCIATED
WITH THE TREATMENT OF MALIGNANT
NON-MALIGNANT LUNG DISORDERS AND
EVOLVED OVER TIME TO MEET THE
MEDICAL NEEDS OF THESE DEMANDS.
SO IN THE NEXT FEW SLIDESLY
HIGHLIGHT SOME KEY
ACCOMPLISHMENTS IN WHICH TO
INITIATE DISCUSSION OF NOW AS
REQUESTED BY THREE OF THE CORE
BSA MEMBERS.
NEXT SLIDE PLEASE.
THE CURRENT U 24 GRANT AWARDED
IN 2018 AND HAS SINCE THEN MET
MANY RFA REQUIREMENTS FOR
DEVELOPING AND UTILIZING THE
REGISTRY AS SHOWN HERE.
AMONG THESE ACCOMPLISHMENTS THEY
WERE REALLY GROUND BREAKING
IMPROVEMENTS THAT MARK A HUGE
STEP FORWARD FOR THE REGISTRY.
THIS INCLUDED SUBSTANTIAL
INCREASE IN ENROLLMENT BY IS
ABOUT 72,000 NEW PATIENTS THAT
NOT ONLY RECEIVED ALLOGENEIC
AUTOLOGOUS AND ADAPTIVE CELL
THERAPY FOR TRANSPLANT
PROCEDURES BUT ALSO ADOPTED CELL
THERAPY THAT WAS USED IN PRIMARY
THERAPY TO TREAT HEMATOLOGIC
MALIGNANCY.
AS A RESULT THE DATABASE
CONTAINS INFORMATION MORE THAN
575,000 PATIENTS.
IN MARCH LAST YEAR THEY ADAPTED
DATA COLLECTION PROCESSES, AND
THIS WAS DETAILED INFORMATION
DIAGNOSIS TREATMENT AND OUTCOMES
OF SARS COV-2 INFECTION AND
INTEND WAS TO SEE DETERMINE
IMPACT OF UPON TRANSPLANT
PRACTICES AS WELL AS SURVIVAL.
THERE WAS FIVE PUBLICATIONS THAT
HAVE BEEN PRODUCED SO FAR, AMONG
THE 297 PUBLICATIO PUBLICATIONS AND THE
SAME TIME PUBLICATIONS FOCUSED
ON REAL WORLD ISSUES WITH
REGARDS TO TRANSPLANTS.
LAST BUT NOT LEAST DATA
TRANSFORMATION TEAM ACTUALLY
DEVELOPED THE TECHNOLOGY
PLATFORM AND SEVEN DATA SHARING
APPS TO EXPEDITE DATA COLLECTION
AS WELL AS TRANSMISSION AND THIS
CREATED SAVE VALUABLE TIME AND
COST FOR TRANSPLANT CENTERS.
ESPECIALLY WITH CENTERS THAT
REPORT MILLIONS OF DATA POINTS
PER YEAR, NEXT SLIDE PLEASE.
ANOTHER HALLMARK ACHIEVEMENT WAS
ESTABLISHMENT OF PUBLIC PRIVATE
PARTNERSHIPS TO CHECK CAR T-CELL
THERAPY DATA USED TO TREAT
HEMATOLOGIC MALIGNANCIES.
THE REGISTRY WAS ADAPTED IN
RESPONSE TO A SPECIAL REQUEST
FROM THE FDA TO NCI TO USE THE
CIBMTR FOR POST MARKET STUDIES.
THESE POST MARKET STUDIES
REQUIRE 15 YEARS FOLLOW-UP
SAFETY ADVOCACY INFORMATION ON
THE CAR T-CELL PRODUCTS AND IN
TURN CIBMETER WILL GIVE ACCESS
TO CLINICIANS STAKEHOLDERS TO
ADVANCE ADOPTIVE CELL THERAPY
RESEARCH.
THERE ARE NOW FIVE POST MARKET
STUDIES UNDERWAY AND IN ADDITION
TO THAT, THERE ARE OTHER NCI
FUNDED COLLABORATORS THAT ARE
ALSO PROVIDING CAR T-CELL
RESEARCH DATA SETS FOR SECONDARY
RESEARCH THAT WILL BE AVAILABLE
UPON COMPLETION.
THIS SPECIFICALLY REFERRING TO
THE AIDS MALIGNANCY CONSORTIA,
CONSORTIUM AND BLOOD MARROW
TRANSPLANT -- THE BLOOD MARROW
CLINICAL TRIALS NETWORK AS WELL
AS NATIONAL CLINICAL TRIALS
NETWORK.
NEXT SLIDE PLEASE.
THE NETWORK IS ALSO VERY
SUCCESSFUL PROGRAM WHERE LINKING
DATA SETS HAS INFORMED CLINICAL
PRACTICE, AS ILLUSTRATED HERE IN
THESE TWO EXAMPLES.
THE FIRST STUDY REAL WORLD DATA
WAS COLLECTED FROM TWO NOVARTIS
POST MARKET STUDIES THAT
ACTUALLY CONFIRM SAFETY AND EF
EFFICACY FINDINGS OF THE HE
WILLIANA TRIAL FOR PEDIATRIC
LYMPHOBLASTIC LEUKEMIA AS WELL
AS JULIA TRIAL FOR NONHODGKINS
LYMPHOMA.
THE RESULTS THE TREATMENT WERE
SAFE AND TOLERABLE WHEN USING
STANDARD DRUG THERAPIES TO
MITIGATE THE OVERREACTIVE IMMUNE
INFLAMMATORY RESPONSE ALSO
SIMILAR WITH REGARDS TO SURVIVAL
SO WHAT THIS SHOWS IS THE
ABILITY TO TRANSLATE THE
TREATMENT INTO PRACTICE.
THE SECOND STUDY, IS A LARGE
MULTI-OMIC PROJECT THAT IS
DESIGNED TO IDENTIFY GENETIC
EPIGENETIC PROTEOMIC SIGNATURES,
THAT MAY PREDICT SURVIVAL
OUTCOMES FOR MILD DYSPLASTIC
SYNDROME PATIENTS THAT ARE
RECEIVING ALLOGENEIC TRANSPLANT.
THE FIRST STEP IN THIS
MULTI-STATE PROGRAM WAS TO
ANALYZE DATA FROM 1500 HEALTHY
DATA DONOR AND MDS RECIPIENT
SPECIMENS TO LOOK AT THE GENETIC
MUTATIONS AND RESULTS WERE THEY
FOUND THAT THE PROGNOSIS WAS
POOR FOR PATIENTS THAT HAD TP 3
MUTATION AS WELL AS THE RAS AND
JACK 2 PATHWAY MUTATIONS THAT
WERE DUE TO TRANSPLANT
COMPLICATIONS OR RELAPSE.
ADVERSE EFFECT OF THE RAS
MUTATIONS CAN ALSO BE OVERCOME
TO CERTAIN DEGREE BY USING THE
HIGH INTENSITY PRE-TREATMENT
CONDITION.
SO THE PROCORRECT NOT MOVING
FORWARD TO LOOK AT PROTEOMIC
PROFILING, TO BE ABLE TO
IDENTIFY THE BENEFITS OF
TRANSPLANT PROCEDURES AND
UNDERSTAND WHAT -- UNDER WHAT
CONDITIONS.
NEXT SLIDE PLEASE.
SO WHERE DO WE GO FROM HERE.
NCI PROPOSES TO MAINTAIN CURRENT
ORGANIZATIONAL PRACTICES AND THE
ONGOING DATA COLLECTION AND AS
WELL AS TO ENSURE WE MAINTAIN
FOCUS ON THESE SPECIAL
INITIATIVES AND SUPPORT OF THE
HHS PROGRAMS.
THIS IS ESPECIALLY IMPORTANT
BECAUSE WE -- THE NUMBER OF
CELLULAR THERAPIES EXPECTED WITH
REGARDS TO THE LONG TERM
FOLLOW-UP STUDIES, WILL IT BE
SUBSTANTIAL OVER THE NEXT COUPLE
OF YEARS.
ALSO WHAT WE ARE TO POSING IS A
NEW DIRECTION THAT WILL REQUIRE
MORE STRENGTHENING ACADEMIC
PARTNER AND PRIVATE PARTNER
RELATIONSHIPS IS TO COLLECT
ADOPTIVE CELL THERAPIES FOR
SOLID TUMORS.
ALL THIS WHILE STILL PROVIDING
THE NECESSARY SUPPORT
STATISTICAL SUPPORT FOR TRIALS
AND OTHER RESEARCH STUDIES.
THANK YOU FOR YOUR ATTENTION
>> THANK YOU VERY MUCH.
MIKE, ARE YOU LEAD THE
DISCUSSION?
>> YES.
CAN YOU HEAR ME?
>> BE YES, G GO AHEAD MIKE.
>> I WILL SPEAK ON BEHALF OF DR.
FABRIS HARBOR AND MEAT WE E
REVIEWED IT AND THOUGHT IT WAS
AN OUTSTANDING EXCEPTIONAL
PROGRAM, MON STRAITED ACTIVITY,
ALL THE CHARACTERISTICS OF A
GOOD CON SOURCEIAL PROGRAM OF
IMPACT IN A VERY UNIQUE NICHE.
ITS COLLECTION OF BIOSPECIMENS
AND DATA AND SHARING COMMUNITY
AND LINK TO GENERAL PROTEOMICS
ARE COB TON GARAGE LATEDED FROM
THE NCI.
THE ONLY REASON WE WANTED TO
HAVE IT PRESENTED HERE IS TO
HAVE THE PROGRAM WHAT IS A GOOD
EXAMPLE OF WHAT CAN BE DONE AT
THE NCI.
I WILL HAND IT TO MY COLLEAGUES
SYLVIA AND BOB SCHRIEBER.
BOB IS NOT HERE BECAUSE OF
FAMILY EMERGENCY SO SYLVIA.
>> MICHAEL, THAT WAS TERRIFIC.
DR. HENDERSON THANK YOU FOR THAT
PRESENTATION.
COMPLETELY AGREE, THIS IS REALLY
REMARKABLE PROGRAM AND I THINK
IT IS A MODEL PROGRAM.
THE SUCCESSES WITH THE
BIOSPECIMEN COLLECTION AND DATA
SHARING AND THE DATA LINKAGES
ARE VERY EXCITING TO SEE AND WE
WERE -- WE REALLYING HOW IT WAS
IMPORTANT FOR THE COMMITTEES TO
HEAR ABOUT IT.
SO THANK YOU.
>> ANY FURTHER QUESTIONS OR
COMMENTS?
GO AHEAD TIM.
HEMATOPOIETIC MALIGNANCY, THE
FIELD WOULD BE LOST WITHOUT THIS
RESOURCE.
ONE OF THE FINEST EXAMPLES HOW
NCI SUPPORT FOR LARGE COLLECTIVE
RESEARCH COLLABORATION HAS BEEN
TRANSPERFORMTIVE AND SO CRITICAL
FOR EVERYTHING THAT WE DO.
THANKS.
>> UNIQUE NICHE REALLY SPANNING
SPECTRUM OF THINGS NCI WANTS TO
HANDLE IN EXTREMELY GROUP
GRATEFUL OPPORTUNITY FOR
COLLABORATORS.
>> SEEING NO OTHER HANDS, LET'S
MOVE TO VOTING.
MIKE COULD YOU MAKE A MOTION.
>> MAKE A MOTION TO ACCEPT
RENEWAL OF THIS.
AND WITH STRONG KUDOS.
>> THAT IS A BIG CONCURRENCE
MOTION SYLVIA, SECOND THAT?
>> SECOND.
>> SO GIVEN THAT READY FOR
DISCUSSION MOTION IS FOR
CONCURRENCE.
THAT WILL BE YOUR DEFAULT MODE.
PSA MEMBERS NOT ON SCREEN,
ANYONE VOTING NOT CONCUR VOICE
THAT OR RAISE YOUR HAND.
I SEE NONE.
ANY ABSTENTIONS.
SO NO ABSTENTIONS.
>> OKAY.
SO WE HAVE ANOTHER REISSUANCE
RFA TO KEEP THE LANGUAGE IN MIND
THERE.
THIS IS A PATIENT DERIVED
XENOGRAPH DEVELOPMENT AND TRIALS
CENTER NETWORK.
U 54 MECHANISM PDX DATA COMMONS
AND COORDINATING CENTER
PRESENTED BY DR. MOSCOW,
SUBCOMMITTEE CHAIR BY DAVE
SEDRANSKI, AND MIKE BECICH.
I BELIEVE DAVID COULDN'T BE WITH
US SO DR. MICHAEL WITH
DISCUSSION SO JEFF WHY DON'T YOU
GET GOING WITH THE PRESENTATION.
>> THANK YOU, GOOD AFTERNOON.
AND THANK YOU FOR THE
OPPORTUNITY TO PRESENT OUR
REQUEST FOR REISSUANCE OF RFAs
TO CONTINUE PDX NET COMPOSED OF
PDX AND TRIALS ACCEPTOR U 24
AWARD.
THIS IS A JOINT PROGRAM BETWEEN
THE DIVISION OF CANCER TREATMENT
AND DIAGNOSIS AND THE CENTER TO
REDUCE CANCER HEALTH
DISPARITIES.
THE ORIGINAL GOALS OF THE PDX
NET IN 2017 WHEN IT WAS FIRST
SET UP WERE TO TEST THERAPEUTIC
STRATEGIES AND LARGE SCALE CLECS
TO PROVIDE PRE-CLINICAL IN VIVO
EVIDENCE TO SUPPORT NOVEL EARLY
BASED CLINICAL TRIALS TO ADDRESS
CRITICAL SCIENTIFIC ISSUES
RELATED TO USE OF PDX MODELS OF
CLINICAL BENEFIT THROUGH
COLLABORATIVE NETWORK STRUCTURE
PDX NET AND CONTRIBUTE NEW PDX
MODEL TO NCI PATIENT DERIVED
MODEL REPOSITORY FOR
DISTRIBUTION OF WIDER RESEARCH
COMMUNITY.
WHEN ADDITIONAL PDCs WERE
GOWNED THE NET WORK THROUGH
CENTER OF REDUCE CANCER HEALTH
DISPARITIES WE ADD ADDITIONAL
GOALS TO INCREASE THE DIVERSE
REPRESENTATION AND STUDY OF
RACIAL ETHNIC MINORITY
POPULATIONS IN PDX NET AND
REPRESENTATION IN THE PDMR AND
TO ADVANCE CANCER HEALTH
DISPARITIES RESEARCH.
THIS H IS THE CURRENT STRUCTURE
OF PDX NET BY THREE RFAs WITH
THE -- WHICH WILL ULTIMATELY NOW
BE REDUCED TO TWO RFAs, THE
ORIGINAL FOUR ARE SHOWN ON THE
LEFT WITH TWO ADDITIONAL PDC
BROUGHT IN A YEAR LATER THROUGH
THE CRCHD, ALL INTERACTING WITH
THE COORDINATING CENTER AND THE
PDMR REPOSITORY.
THE ENTIRE NETWORK INTERACTED
WITH OTHER LABORATORY BASE
INVESTIGATORS TO A SUPPLEMENT
PROGRAM AND WITH THE ETCTN AND
OTHER NCI CLINICAL NETWORKS FOR
CLINICAL TRANSLATION OF
EXPERIMENTAL RESULTS.
THE ACCOMPLISHMENTS IN THE FIRST
CYCLE INCLUDED THE COLLABORATION
WITH CRCHD TO BRING IN THEIR TWO
ADDITIONAL PETCs FOCUSED ON
DISPARITY RESEARCH P. IT REALLY
DID DEVELOP A CULTURE
COLLABORATION AMONG ALL GRANTEES
WITH MULTIPLE COLLABORATIVE
RESEARCH PROJECTS.
I THINK THAT THE INVESTIGATORS
IN THE NETWORK CAPITALIZE ON
NETWORK STRUCTURE AND RESOURCE
TO TRULY COLLABORATE ON NETWORK
WIDE RESEARCH PROJECTS INCLUDING
DEMONSTRATION MULTI-CENTER
EXPERIMENTAL REPRODUCIBILITY OF
DRUG RESPONSE STUDIES USING PDX
MODEL DEMONSTRATION OF COPY
NUMBER ALTERATION FIDELITY AND
SUCCESS PDX PASSAGES TAKING
NETWORK AND SHOWING IDENTICAL
RESULTS DEMONSTRATION OF
THERAPEUTIC TARGET PATHWAY
IDENTIFICATION AND ONGOING COST
NETWORK COLLABORATIVE STUDY OF
GREAT EFFICACY EVALUATION
METHODS IN PDX MODELS TO
DETERMINE HOW WE MIGHT SET
STANDARDS FROM MEANINGFUL
REPORTING OF DRUG RESPONSE
EXPERIMENTS.
THESE COLLABORATIVE PROJECTS IN
THEIR SUCCESS HAS NOW LED TO TEN
ACTIVE INTERNETWORK
COLLABORATIONS THAT ARE BY THE
COORDINATING CENTER.
IN ADDITION THE INVESTIGATORS
DONATED 690 UNIQUE MODELS TO THE
PDMR MOST ARE IN PROCESS IS OF
EXPANDING PRIORITIZATION PRIOR
TO PUBLIC DISTRIBUTION.
PRE-CLINICAL EVIDENCE DEVELOPED
FROM 10CTEP LOI.
A WEBSITE FOR INTERNAL NETWORK
COLLABORATION BUT ALSO FOR
PUBLIC ACCESS TO OUR DATA AND TO
SOPs.
AND AS DR. SHAW WAS MENTIONS A
FEW DAYS COLLABORATION REQUIRE
DATA SHARING REQUIRE DEVELOPMENT
OF TOOLS TO FACILITATE IT AND
THAT CERTAINLY BEEN THE CASE,
COLLABORATIVE PROJECTS FROM
WITHIN PDX NET AND RESULTED IN
15 VALIDATED WORK FLOWS, THAT WE
USE TO FACILITATE THE
COLLABORATIVE PROJECTS WHICH ARE
NOW ALSO SHARED WITH THE PDX
SUPPORT.
ALSO THE RESEARCH GRANTS
ORIGINAL RESEARCH PROJECTS
ONGOING AND 88 ORIGINAL
PUBLICATIONS HAVE BEEN PUBLISHED
FROM RESEARCH FROM PDX
INVESTIGATORS.
WE UNDERWENT EXTERNAL REVIEW OF
PDX NET REVIEWERS
ENTHUSIASTICALLY SUPPORTED
RENEWAL OF IT.
WITH SCORES AS YOU CAN SEE ON
THE ONE TO NINE RANGE FOR -- HA
WE USE FOR GRANT EVALUATION.
REVIEWSERS NOTED PROGRESS
DESCRIBING THE PROGRESS REPORT
WAS MADE ONLY AFTER THREE AND A
HALF YEARS AND TWO AND A HALF
YEARS IN THE CASE OF CHHD PDTC E
SO MADE DURING THE PANDEMIC
WHICH PLACED SEVERE PERSONNEL
RESTRICTIONS.
OUR DISCUSSION FOCUSED ON TUMOR
VOLUME ANALYSIS WORK AND
ENCOURAGED US TO WORK TO
ESTABLISH CONSENSUS METRICS FOR
DRUG RESPONSE, FOCUSING
SUPPLEMENT PROGRAM WITH
COLLABORATIONS FROM CLINICIAN
SCIENTIST AND WE DID DISCUSS
IMMUNO-ONCOLOGY ISSUES AND HOW
THEY MIGHT BE EVALUATED IN PDX
NET BUT IT IS COMPLICATED AND --
NEXT SLIDE.
WE RECEIVED INFORMATION FROM
SUBCOMMITTEE, AND THANKED THEM
FOR INPUT DEFINING DELIVERABLES
FOR THE SECOND GRANT CYCLE
INCLUDING DEVELOPMENT AND
APPLICATION OF DRUG RESPONSE
EVALUATION STANDARDS ACROSS PDX
NET APPLYING THEM IN OUR OWN
PUBLICATION -- IN THEIR OWN
PUBLICATIONS AND ADVOCATING FOR
ADOPTION ACROSS THE THE WIDER
RESEARCH COMMUNITY.
PROVIDE ROBUST DATA TO
PRIORITIZE 20 CLINICAL TRIALS
NCI CLINICAL TRIAL NETWORKS
WHICH IS REALLY CAN YOU BELIEVE
FROM THE FIRST CYCLE.
AND THIS THIRD POINT WAS TO
FOCUS OF OUR DISCUSSION WITH BSA
COMMITTEE MEMBERS REGARD MAKING
MORE STRATEGIC DOE NEIGHS TO
PDR.
THIS REFLECTS BY DEFINING HOW
PDX WILL BE MORE FOCUSED IN
DONATION FROM THE PDMR REQUIRING
GAPS IN REPOSITORY COLLECTION
AND METHODS TO ORCHESTRATE
TARGETED COLLECTIONS TO FILL
THOSE GAPS, TO INCLUDE RACIALLY
ETHNICALLY UNDERSERVED MODEL OR
MODELS FROM PATIENTS WHO ARE
CLINICALLY RELAMENTED OR WHO ARE
-- RELAPSED OR RESISTANT TO
THERAPY.
IN ADDITION, USING THE NETWORK
COLLABORATIVE PROJECT AS ENGINE
TO GUIDE DATA INTEGRATION
NETWORK SHOULD CONTINUE TO
CREATE METHODS AND WORK FLOWS TO
INTEGRATE COMPLEX OMIC DATA FROM
MULTIPLE SITES, DO A SEARCHABLE
DATABASE MODEL SECTION SELECTION
AND MAKE TOOLS PUBLICLY
AVAILABLABLE AND FACILITATE
PRODUCTIVE COLLABORATION BETWEEN
PX NET SCIENTIST AND EARLY PHASE
CLINICAL TRIALISTS.
NEXT SLID PLEASE.
SO THE U 54 WOULD BE REQUIRED TO
HAVE TWO RESEARCH PROJECTS AND
MECHANISM BASED DRUG
COMBINATIONS GENETICALLY OR
HISTOLOGICALLY DEFINE TUMOR SUB
GROUPS THAT EXPLORE RELATIONSHIP
WITH TUMOR CHARACTERISTICS AND
TUMOR DRUG RESPONSE.
CRCHD TRACK FOCUS ON MODELS
RELEVANT TO CANCER HEALTH
DISPARITIES.
EACH U 54 HAVE FOUR REQUIRED
CORES AND EXPECTATION RESEARCH
PROJECTS WOULD EMPLOY LARGE
SCALE PDX COLLECTIONS.
NEXT SLIDE.
THE U 24 WOULD HAVE TWO CORES
BIOINFORMATICS CORE, CONTINUE TO
WORK LEADING THE DEVELOPMENT AND
IMPLEMENTATION OF DATA STANDARDS
WORK FLOWS SOPs AND
HARMONIZATION DATA INTEGRATION
ACROSS THE DIFFERENT PEDCs AND
CONTINUE TO MAINTAIN WEBSITE AND
ADMINISTRATIVE CORE AS
LOGISTICAL AND ADMINISTRATIVE
CENTER.
NEXT SLIDE.
THE SUPPLEMENT PROGRAM IN THE
PAST IN THE FIRST CYCLE WAS
GIVEN TO LABORATORY SCIENTIST
OUTSIDE PDX NET TO COLLABORATE
WITH LABORATORY SCIENCE
INVESTIGATED WITHIN PDX NET AND
OVERALL THE PRODUCTIVITY WAS
FELT MODEST.
WE FELT EXTERNAL COMMITTEE FELT
THAT IT WOULD BE BEST TO
RESTRUCTURE THIS TO FACILITATE
INVESTIGATOR INITIATED CLINICAL
TRIALS BY PROVIDING CLINICIAN
SCIENTISTS ACCESS TODX NET FOR
PROPOSED THERAPIES,
COLLABORATION BETWEEN CLINICIAN
AND THE PDX NET INVESTIGATORS
COULD INCLUDE BIOMARKER
DEVELOPMENT INVESTIGATION
MECHANISM TO PDX RELATED
RESEARCH QUESTIONS.
NEXT SLIDE.
SO THE BENEFITS OF THE PROPOSED
FOA AND THE REISSUE IS THIS
NETWORKTRANSSENDS SILO
STRUCTURE OF PDX PROGRAMS THAT
IT CREATES INTEGRATED
COORDINATED COLLABORATIVE
NETWORK OF PDX CENTERS OF
EXCELLENCE TO ADDRESS MULTIPLE
SCIENTIFIC ISSUES, IT FOCUSES ON
THE DEVELOPMENT OF PRE-CLINICAL
IN VIVO EVIDENCE MORE RAPID
TRANSLATION TO INTEGRATION WITH
NCI CLINICAL NETWORKS, IT
CREATES HARMONIZE WORK FLOWS TO
FACILITATE COLLABORATION AND
SHARING THOSE SOP AND WORK FLOWS
WITH A COMMUNITY AND FACILITATES
MULTI-CENTER DONATION OF PDX
MODEL TO PD MARKET FILL IDENTIFY
RESOURCE GAPS.
IT IS A PURPOSE DRIVEN
CONSORTIUM FOR PRACTICAL
APPLICATION OF PDX BY
INTEGRATING PDX SCIENTIST.
THE NEXT PROGRAM IN CLINICAL
SCIENTIST AND CLINICAL TRIAL
NETWORK CREATING A COMPLETE
ENTERPRISE FOR DEVELOPMENT OF
PRECISION CANCER MEDICINE.
IT ADDRESSES OUR NEED FOR IN
VIVO EVIDENCE TO PRIORITIZE
TARGETED AGENT COMBINATIONS,
MOLECULARLY DEFINED TUMORS FOR
NCI CLINICAL TRIAL DEVELOMENT
AND IT COMPLIMENTS THE DIVISION
OF CANCER BIOLOGY PATIENT
DERIVED MODEL OF CANCER PROGRAM
WHICH FOCUSES ON THE BIOLOGY OF
PATIENT GUIDELINES.
NEXT SLIDE.
SO THIS IS THE BUDGET, THE
CURRENT FUNDING LEVEL IS
$10.5 MILLION A YEAR, CANCER
MOON SHOT PROGRAM AND WE HAVE
PROPOSED DECREASING TOTAL COSTS
TO $8 MILLION A YEAR DECREASING
THE NUMBER OF DEVELOPMENT AND
TRIAL CENTERS FROM 6 TO 5 AND
DECREASING THE BUDGET OR THE
COORDINATING CENTER AND -- OF
THE SUPPLEMENT PROGRAM.
NEXT SLIDE.
SO THANK YOU, VERY MUCH TO
ASSIST IN ANSWERING QUESTIONS
I'M HERE WITH TIFFANY WALLACE
FROM CENTER TO REDUCE CANCER
HEALTH DISPARITIES.
YVONNE FROM THE PATIENT GUIDE
MODEL REPOSITORY AND KIM
WITHERSPOON WHO IS OUR
INVESTIGATION DRUG BRANCH,
BRANCH MANAGEMENT SPECIALIST,
POOLS PAPERWORK TOGETHER.
THANK YOU VERY MUCH AND HAPPY TO
ANSWER QUESTIONS.
>> THANKS, JEFF.
SHOULD I CONFIRM IN THE
PARTICIPANT LIST -- IS NOT WITH
US SO DAVE CAN YOU GET US
STARTD?
>> THANK YOU, DR. MOSCOW,
TERRIFIC PRESENTATION, THANK YOU
SO MUCH FOR RESPONDING TO OUR
MANY QUESTIONS THAT WE HAD OF
THE PROGRAM.
IT IS ORIGINAL INTENTIONS WERE
AND WHAT YOU LEARNED DURING THE
PAST FOUR YEARS HOW YOU MODIFY
THINGS TO MEET THE GOALS OF WHY
IT WAS SET UP IN THE FIRST
PLACE.
I WANT TO START BY ADDRESSING
THE COVID PANDEMIC YOU TALKED
HOW INVESTIGATOR HAD A HARD TIME
MANAGING LARGE ANIMAL COLONIES
DURING THAT TIME BECAUSE OF
PERSONNEL LIMITATIONS THE OTHER
ISSUE, THIS IS A PROGRAM TOTALLY
DEPENDENT ON ACQUISITION OF
FRESH HUMAN TUMORS.
AND MOST CANCER SURGERIES
STOPPED ACROSS THE COUNTRY.
SO THE BIG HIT TO THIS PROGRAM
IS THERE WERE NO SAMPLES.
FOR 18 TO 24 MONTHS.
YET YOU STILL MADE 690 SAMPLES
WHICH SHOULDN'T BE OVERLOOKED.
SO THAT WAS GREAT.
THE CONCEPT OF PDX IS CAN WE
LEARN ABOUT HUMAN CANCER TO HELP
OTHER HUMANS WHO HAVE CANCER
LIKE THIS, AND/OR CAN WE HELP
THAT PATIENT WITH THIS CANCER?
CAN IT GO ALL THE WAY TO A
PERSONALIZED MEDICINE
APPLICATION?
THE PDX SPACE IT IS STILL
UNCLEAR BECAUSE IT TAKES
SOMEWHERE MORE THAN SIX UP TO 24
MONTHS GENERATE GOOD PDX LEVELS
WHERE YOU HAVE ENOUGH MICE SO
YOU CAN DO TREATMENT IN THERAPY
AS WELL AS COMBINATION THERAPY.
THE IMPORTANT POINTS THIS GROUP
IS WORKING ON IS STANDARDIZATION
SO THAT WE CAN ANSWER THAT
QUESTION.
SO AGAIN THE POINT OF HAVING
MULTIPLE SITES AROUND THE
COUNTRY, WILL IN FACT TRY TO
REPRODUCE THE SAME EXPERIMENT
WITH THE SAME MODELS.
IT IS TOTALLY ESSENTIAL.
RIGOR AND REPRODUCIBILITY
SOMETHING ON OUR GRANTS NOW
THANKS TO ALL OF US THINKING
ABOUT IT AND END ADOPTING IT,
THIS WILL ADDRESS IT IN
STANDARDIZATION OF PDX AS A
MODEL.
PERSONALIZING MEDICINE USING I
WOULD SAY IS A HARD SELL FOR A
LOT OF OUR PATIENTS, BUT WE WILL
ONLY GET TO THAT AFTER THE
STANDARDIZATION IS COMPLETE.
SO AGAIN THAT IS A HIGHLIGHT FOR
YOU.
I ORIGINALLY WHEN I LOOK AT
BUDGET AND THOUGHT HARD ABOUT IT
I WONDERED WHY THIS WASN'T 16
RO1 OPPOSED TO SIX PROJECTS.
AS I DUG INTO IT AND REALIZED IT
HAD THESE CORES TO DO THIS WORK
SO YOU CAN STANDARDIZE PROPERLY
I RETREATED FROM MY ORIGINAL
POSITION ON IT, TO PUT MORE
RO1s ON THE BOARD WHENEVER I
CAN.
I CAN'T DO THAT IN THIS SETTING,
STANDARDIZATION IS STILL THE
NUMBER ONE OBJECTIVE WE HAVE
HERE.
STANDARDIZED PROPERLY SO WE CAN
MOVE INTO ORIGINAL HYPOTHESIS
DIRECTED QUESTIONS.
THIS LAST PART THOUGH ABOUT WHAT
YOU WANT TO DO IN THE FUTURE AND
LINKING MORE TO ECTN,
INVESTIGATORS.
I THINK IS ALSO QUITE IMPORTANT
AND WILL ALLOW IN REAL TIME
THESE MODELS TO BE INCORPORATED
IN THE DESIGN OF TRIALS OPPOSED
TO AFTER SOMEONE READ IT IS
PAPER AFTER APPROVAL AND AFTER
THEY APPLY FOR SO I THINK THAT
IS A GOOD DIRECTION TO TAKE IT.
FINALLY THIS ISSUE ABOUT
DIVERSITY AND MODELS, IT IS A
HUGE PROBLEM EVEN PDX AS YOU
KNOW.
AS WE HAVE HEARD OVER THE LAST
TWO DAYS.
I WOULD SAY TO INCORPORATE THAT
EARLY ON WILL BE IMPORTANT GIVEN
PRESENTATION THESE LAST TWO
DAYS.
IT HAS AN EARLY ADOPTER OF THIS
I CAN TELL YOU WE ARE LEARNING A
LOT SOMETIMES, PROBABLY
HAVEMOGTO DO WITH MACRO
ENVIRONMENT WE ONLY KNOW BECAUSE
WE ARE MAKING THESE MODELS.
SO I'M GOING TO TURN OVER TO DR.
BESICH WHO WROTE DOWN POINTS
THAT LED TO IMPROVEMENT IN YOUR
PROTOCOL.
DAVID AND I DISCUSSED OFFLINE A
HEAD OF TIME, HIS MAIN CONCERN
IS CHAMPIONS ONCOLOGY, THERE YOU
HAVE THOUSANDS OF MODELS.
WHY COULDN'T ACADEMIC CALL THAT
A CHAMPIONS AND GET THINGS?
THE REASON I TALKED ABOUT
BEFORE, STANDARDIZATION.
INCORPORATION OF MODEL IN
PRACTICE ACROSS OUR COUNTRY.
DAVID IS RIGHT GETTING
LONGITUDINAL SAMPLES THAT YOU
WILL ALLOW SECOND PHASE WILL BE
IMPORTANT SO DRUG RESISTANCE CAN
BE STUDIED.
MIKE I DON'T KNOW IF YOU WANT TO
ADD ANYTHING TO THIS.
>> COMMENTS RIGHT ON POINT
DAVID, THANK YOU FOR GREAT
SUMMARY.
I THINK KEY ISSUE IS INs AND
OUTS OF THIS PROGRAM METRICS FOR
MOCH DATA IS SHARED HOW MANY
MODELS HAVE BEEN OUT THERE, WHAT
IS THE TIME LINE FOR DELIVERING
THOSE MODELS, TO THE CANCER
RESEARCH COMMUNITY AT LARGE.
THE INTERACTION BETWEEN THE
PEOPLE WHO ARE FUNDED ARE
SPECTACULAR.
ON THE OTHER HAND THIS IS
SUPPOSED TO BE FACILITY HELP
WITH BIG OUTBOUND ARROW THE REST
OF THE NCI COMMUNITY.
THERE HAVE BEEN SEVERAL PROGRAMS
WAITING FOR STUFF FUNDED ACROSS
THE NCI THAT WE ARE GOING TO
COUNT ON THESE MODELS AND ARE
STILL NOT GETTING THEM.
SO FOR ME THE INs AND OUTS
THAT NEED TO BE CAREFULLY
DOCUMENTED IN THIS PROGRAM,
CLEARLY THIS IS AN IMPORTANT
PART OF THE WAY WE CAN LOOK AT
WAYS TO DELIVER NEW DRUG TARGETS
AND TEST THEM GREAT PROMISE, BUT
I DO THINK IT IS A LONG TIME
BIOREPOSITORY SCIENTIST.
MENT THE PROOF IS NOT YET THERE
IMPACT OF OVERALL SCIENTIFIC
COMMUNITY AND NUMBER OF PATIENTS
IS QUITE SMALL.
>> THANK YOU, DR. BARKER.
SO I WANT TO FOLLOW UP ON THAT
POINT, MICHAEL.
YOU HAVE A U 54 MECHANISM AND U
24.
SO I NEED TO UNDERSTAND ARE YOU
JUST SETTING UP THE COORDINATING
CENTERS NOW OR CENTER AND DATA
COMMONS OR ARE THEY ALREADY IN
PLACE?
>> THERE WAS ALREADY HAS BEEN
2024 COORDINATING CENTER, IT WAS
A JOINT GRANT BETWEEN JACKSON
LABS AND SEVEN BRIDGES WHO DID
COORDINATED ALL THE INFORMATICS
AND INFRASTRUCTURE THAT WERE
NEEDED FOR ALL OF THIS.
SO THERE ISN'T REISSUANCE OF
THAT.
THAT'S IN EXISTENCE.
>> THE COORDINATING CENTER IS
EXISTENCE.
SO I WANT TO GET BACK TO THIS
QUESTION OF STANDARDIZATION.
THIS IS GOING TO BE CAREER GOAL
FOR THIS, TO WHAT EXTENT IS THE
COORDINATOR CENTER WORKING ON
THAT ISSUE?
>> I THINK THERE ARE A COUPLE OF
AREAS, FIRST THING THE GROUP DID
WAS TO TAKE MODELS FROM THE PDMR
AND THE DRUG AND SEE IF THEY CAN
EACH THE MODEL AND THE DRUG
THREE MODELS AND A DRUG AND TOLD
TO SEE WHICH TUMORS RESPOND TO
THE DRUG AND TO PLOT THEIR DATA
AND THEN Y'ALL PUT THE DATA
TOGETHER AND ONE OF THE FURTHER
THINGS WE LEARNED IS EVERYBODY
DID EXPERIMENTS DIFFERENTLY AND
THE DATA, EVERYTHING HAD TO BE
HARMONIZED BECAUSE IN ORDER TO
COMPARE THE DATA, YOU HAD
EVERYBODY DOING EVERYTHING
DIFFERENTLY.
TURNED OUT WHEN YOU FINALLY GOT
EVERYTHING DONE HARMONIZED WAY
YOU CAN SEE EVERYBODY ENDED UP
WITH THE SAME RESULT SO GREAT
BECAUSE EXPERIMENT WAS
REPRODUCIBLE BUT IT TOOK SOME
TIME TO FIGURE O THAT OUT
BECAUSE EVERYTHING AGAIN
EVERYBODY HAD DIFFERENT WAYS OF
REPORTING DATA MEASURING TUMORS
OF RECORDED DIFFERENT DATES,
EVERYTHING ABOUT THE WAY
EXPERIMENTS WERE DONE IN
DIFFERENT CENTERS WAS DIFFERENT.
SO I THINK WHAT -- PART IS --
HEN THE OTHER ISSUE THAT WE H
FOCUS ON NOW IS IF YOU LOOK AT
HOW PDX RESPONSE ARE REPORTED,
IN THE LITERATURE, IT IS ALL
OVER THE PLACE, EVERYBODY DOES
IT DIFFERENTLY.
AND THERE'S NO CONSENSUS ABOUT
WHAT IS A SIGNIFICANT RESPONSE
TO THERAPY AND HOW DO YOU
COMPARE ALL WE DO IT BY EYE BALL
BUT THERE IS NO STANDARDIZATION
FOR THAT.
SO I THINK A LOT OF WHAT WE ARE
TRYING TO DO INITIALLY IS TO TRY
TO STANDARDIZE HOW WE THINK
ABOUT A DRUG RESPONSE AND WHAT
IS A SIGNIFICANT DRUG RESPONSE
AND WHAT WOULD BE A POTENTIALLY
PRE-DICKTIVE RESPONSE SOMETHING
YOU WOULD BE SEEING IN
TRANSLATABLE TO THE CLINIC.
IT IS METHODS, IT IS ABOUT
DEFINITION, IT IS ABOUT HAVING A
COMMON UNDERSTANDING OF WHAT
DRUG RESPONSE IS MEANINGFUL.
HOW DO YOU CAPTURE THE DEPTH AND
DURATION OF RESPONSE OPPOSED TO
A STATISTICALLY DIFFERENT
MEASUREMENT OF A GROWTH RATE AT
ONE POINT IN TIME?
SO THESE ARE ALL ISSUES THAT
NETWORK IS TRYING TO DEAL WITH.
I DON'T KNOW -- I HOPE THAT
ANSWERS YOUR QUESTION.
>> THAT STARTS TO ANSWER THE
QUESTION, I KNOW IT IS A LONG
CONFERENCE SURE IN TERMS OF
CONTINUUM BUT THE OTHER QUESTION
WHAT PERCENTAGE, THESE ARE IDEAL
RESOURCES TO BUILD FOR THE
EXTRAMURAL COMMUNITY, VERY
SUPPORTIVE OF THESE.
THE U 54 IS THE BEST WAY TO DO
THIS.
CURIOUS WHAT PERCENTAGE OF
EXTRAMURAL INVESTIGATORS
PRESENTED A NOVEL, A COMBINATION
OF DRUGS OR DRUG TO BE TESTED
AND HAVE BEEN SUCCESSFULLY
TESTED TO DATE?
ANY EXTRAMURAL INVESTIGATORS
USING THIS RESOURCE YET?
>> SO I THINK -- SO IN TERMS OF
IF YOU ARE ASKING -- IF THE
RESOURCE IS TO THE SAY TORRS ARE
IS INVESTIGATORS BASICALLY
COMING UP WITH DRUG/WE CAN
TRANSLATE TO CLINIC THE ANSWER
IS YES.
AND THAT IS -- AND WE THINK WE
CAN ACCELERATE THAT BY
REPROGRAMMING THE SUPPLEMENT
PROGRAM.
SO WE DID TRY TO -- I THINK WHAT
MAYBE YOU ARE SUGGESTING IS
HAVING OTHER NON-PDX
INVESTIGATORS USE IT TO TEST
THEIR IDEAS THEY WORKED ON
SOMETHING, THEY DIDN'T HAVE PDX
RESOURCES COULD THEY USE PDX NET
FOR -- THAT WAS THE ORIGINAL
GOAL.
I HAVE TO SAY RLZ IT DIDN'T
WORK, A LOT OF PROJECTS THAT
JUST DIDN'T GO ANYWHERE, DIDN'T
SEEM TO EXPERIMENTS WOULD BE
DONE BUT NO FOLLOW THROUGH, SO
OVERALL WE THOUGHT THE -- THAT
IDEA WOULD SEEM GREAT AT THE
TIME IN PRACTICE THE OUTCOME OF
THOSE DIFFERENT PROJECTS, REALLY
DIDN'T SHOW THAT THAT WAS A
PRODUCTIVE WAY BECAUSE --
>> AS WE SAW FROM PRIOR
PRESENTATION, SOMETIME DEVELOP
THINGS IT TAKES TIME TO DEVELOP
CAPABILITY, IT IS A $49
INVESTMENT, GREAT TO SEE THE
ENTIRE COMMUNITY BENEFIT FROM
SOMETHING LIKE THIS.
>> WE HAVE TIME FOR ONE MORE
QUICK QUESTION, MAX YOU HAD YOUR
HAND UP FIRST SO GO WITH YOU.
WE CAN HOPEFULLY TRY TO ADD
JAMES TO THE CHAT.
GO AHEAD MATT.
>> GREAT TO BUILD THIS MODEL BUT
MY CONCERN IS THE BIOLOGY OF THE
MODEL AND HOW MUCH OF INVESTMENT
IS REALLY BEING MADE TO IMPROVE
THE MODELS RATHER THAN JUST MAKE
MORE MODELS FOR MORE PATIENTS.
FOR EXAMPLE YOU WENT BY QUICKLY
THE EXTERNAL GROUP RECOMMENDED
EXPANDING IMMUNE APPROACHES TO
THE POTENTIALLY HUMANIZED MICE
WITH HUMAN IMMUNE SYSTEM.
AND I THINK THAT THAT IS
BECOMING QUITE CONCLUSIVE THAT
RESPONSE TO DRUGS IS VERY
DIFFERENT IN IMMUNE COMPETENT
VERSUS IMMUNOCOMPROMISED
ANIMALS, MY CONCERN IS WE ARE
SPENDING A TREMENDOUS AMOUNT OF
MONEY WITH MODELS THAT MAY NOT
BE THAT REPRESENTATIVE OF WHAT
IS GOING ON, IF THEY ARE LACKING
THINGS LIKE IMMUNE SYSTEM.
I ALSO THINK MONEY NEEDS TO BE
SPENT TO COMPARE MODELS TO
ORGANOID MODELS.
WE HAVE TO KNOW HOW THEY COMPARE
WHAT'S THE DIFFERENCE AND WE
GENERATE ORGANOID MODELS THEY
JUST AS GOOD, NOT AS GOOD AND
CAN WE USE THOSE FOR OTHER
BIOETHIC STUDIES, BOTH ELEMENTS.
>> THE SECOND ONE FIRST ORGANOID
I THINK HAVE TO BE AN IMPORTANT
PART OF THIS CLEARLY WE HAVE TO
BE ABLE TO SCREEN EFFICIENTLY
AND THEN UNDERSTAND PREDICTIVE
HOW TO DO THAT, AGAIN
STANDARDIZATION CAN BE HELPFUL
WITH THAT APPROACH.
THAT'S PART OF THIS.
USE HAVE LARGE SCALE PDX
COLLECTIONS WE NEED A WAY OF
SUFFICIENTLY SCREENING AND WE
CAN'T DO THAT ALL WITHIN THE
EXPERIMENTS.
IN REGARD TO THE BIOLOGY OF OF
PATIENT DERIVED MODELS, STUDYING
THAT IS PART OF DIFFERENT
PROGRAM IN DIVISION OF CANCER
BIOLOGY SO I THINK THERE ARE
REALLY COMPLEX QUESTIONS, HOW DO
YOU INCORPORATE STRUGGLE
ELEMENTS AND IMMUNE SYSTEM
ELEMENTS INTO MODELS.
THAT'S REALLY UNDERSTANDING
ALTERING BIOLOGY IS JUST REALLY
THE FOCUS OF DIFFERENT GRANT
PROGRAMS, I THINK SO I THINK
THAT IS GOING ON, THIS IS REALLY
PROBABLY MORE LIKELY DAD
CATEGORY APPLIED SCIENCE OPPOSE
TO TRYING TO UNDERSTAND THE
BIOLOGY OF MODEL WHICH IS REALLY
IN DCP PROGRAM.
>> GOOD TOMMIC FOR FUTURE
DISCUSSION.
YOUR COMMENTS POINT IN THAT
DIRECTION ALSO.
LET'S MOVE TO VOTING KEEPING AN
EYE ON THE CLOCK.
THIS IS REISSUANCE SO LOOKING
FOR MOTION TO CONCUR OR NOT
CONCUR SO DAVE AS CHAIR.
>> I MOTION TO CONCUR.
THE COMMENTS OF MY COLLEAGUES
NOTWITHSTANDING THEIR CERTAINLY
LOT OF TUMOR MICROENVIRONMENT
TOPICS AND EXVIVO TALK ABOUT.
THIS IS REALLY GOING AFTER CELL
AUTONOMOUS TARGETS CAN THESE BE
USED TO GO AFTER CELL AUTONOMOUS
TARGETS THAT IS THE PLAN OF THIS
PROGRAM.
SO I CONCUR.
>> MIKE.
>> YES I CONCUR.
>> OKAY.
ANY FURTHER DISCUSSION?
OKAY MOTION ON THE TABLE IS A
CONCURRENCE.
LOOKING SPECIFICALLY FOR ANY
VOTES OF NON-CONCURRENCE FROM
BSA MEMBERS.
VOICE OR RAISE YOUR HAND.
MAX YOU HAVE YOUR HAND UP ON
YOUR SCREEN BUT I THINK THAT IS
LEFT OVER FROM YOUR QUESTION.
JUST CAME DOWN.
PAULETTE I SEE OR HEAR NONE.
ANY ABSTENTIONS?
NO ABSTENTIONS.
SO UNANIMOUS CONCURRENCE, NO
ABSTENTIONS PAULETTE.
SO WE MOVE TO LAST PROPOSALS OF
THE DAY, THIS IS A NEW PROGRAM
ANNOUNCEMENT JUST GOING TO
MENTION UP FRONT WE BUDGET ONLY
FIVE MINUTES FOR DISCUSSION.
WHEN WE GET THERE, TEN MINUTES
FOR PRESENTATION.
THIS IS SYSTEMATIC TESTING OF
RADIONUCLIDE IN PRE-CLINICAL
EXPERIMENTS DR. MICHAEL ESPE
WILL PRESENT SUBCOMMITTEE CHAIR
BY KAREN KNUDSEN AND SYLVIA AND
MIKE TAKE IT AWAY WITH YOUR
PRESENTATION.
>> THANKS, NED.
I'M JOINED BY DR. -- WHO MANAGES
THE NCI RADIO PHARMACEUTICAL
PORTFOLIO AND WITH THE RPT
COMMUNITY.
WE THANK THE BSA SUBCOMMITTEE
MEMBERS DR. KNUDSEN FOR THEIR
GUIDANCE WHICH I WILL TOUCH ON
AT THE END.
OUR CONCEPT STRIPE STANDS FOR
SYSTEMATIC TESTING OF RAID YES
NUCLIDE PRE-CLINICAL
EXPERIMENTS.
NEXT SLIDE.
WE ARE REQUESTING APPROVAL OF
PAR TO ADDRESS KNOWLEDGE GAPS
AND HOW RADIO PHARMACEUTICAL
THERAPY OR RPT AFFECTS BIOLOGY
OF CANCER CELLS, NORMAL CELLS
AND TUMOR MICROENVIRONMENT.
THROUGH THIS PAR WE SEEK TO
CATALYZE INTERDISCIPLINARY
COLLABORATIVE PROJECTS THAT WILL
SERVE TO STRENGTHEN THE
PRE-CLINICAL FOUNDATION OF THE
RPT.
NEXT SLIDE PLEASE.
THIS SLIDE COMPARES TO
APPROACHES IN IONIZING RADIATION
THERAPY.
ON THE LEFT IS EXTERNAL BEAM
WHERE INNOVATION IN THE FIELD IS
LARGELY DRIVEN BY DEVICES TO
PRECISELY DELIVER PHYSICAL DOSE.
HOWEVER, SPATIAL TARGETING CAN
BE LIMITED BY THE RESOLUTION OF
DIAGNOSTIC IMAGING.
EFFICACY IS LIMITED BY
INCIDENTAL INJURY TO NORMAL
TISSUES.
ON THE RIGHT YOU SEE RPT WHERE
IMPORTANTLY TARGETING IS BASED
ON TUMOR BIOLOGY AS DEPICTE DEPICTED IN
THE FIGURE DRUG DELIVERLY
CELLULAR SCALE SETTING UP CROSS
FIRE DOSE TO TUMOR CELLS AND
TUMOR MICROENVIRONMENT RPT HAS
VOLATILITY IN LOCAL AND
MICROMETASTATIC DISEASE.
THE PHYSICS OF RADIONUCLIDE
PARTICLES USED IN RPT ARE WELL
KNOWN AND DISTINCT.
ONE WAY TO VISUALIZE THEM IS BY
ANALOGY TO CONSTRUCTION SITE.
ALPHA MISSIONS ARE LIKE A BULL
DOSER VERY POWERFUL AND
DESTRUCTIVE BUT SHORT RANGE.
BETA PARTICLES ARE LIKE BOB CAT
BUT LESS ENERGY TO TRAVEL
FURTHER TO MULTIPLE CELL
LENGTHS.
ELECTRONS ARE LIKE A JACKHAMMER
IMPACTING CLOSE PROXIMITY.
ON THE RIGHT WHICH IS MEANT TO
ILLUSTRATE HOW RPT ACTIONS ARE
FOUND IN THE TUMOR
MICROENVIRONMENT LIMITING
TOXICITY TO NORMAL TISSUE.
RADIO PHARMACEUTICAL THERAPY HAS
DESIRABLE MODULAR QUALITIES AS
ILLUSTRATED IN THE TABLE ON THE
LEFT, KNOWN PHYSICAL PROPERTIES
OF DIFFERENT RADIONUCLIDE
INCLUDE RANGE OF PARTICLE TYPES
WITH HALF LIVES THAT VARY FROM
HOURS TO DAYS AS DEPICTED ON THE
RIGHT THESE CHARACTERISTICS CAN
BE COMBINED WITH VARIETY OF
MOLECULAR TARGETING APPROACHES
INCLUDING NANOTECHNOLOGY OR
ENGINEER CANCER SPECIFIC
ANTIBODIES.
THESE DISCRETE COMPONENTS CAN
HAVE POTENTIAL TO BE BLENDED.
TO PAINTERS PALATE.
CREATE NOVEL STRATEGIES FIT TIE
DRESS SPECIFIC CANCER TREATMENT
NEEDS.
NEXT SLIDE PLEASE.
THE STATE OF ART FIELD IS TOP
LOADED.
AS SHOWN IN THE UPPER LEFT.
SEVERAL RPT AGENTS ARE HAVING
IMPACT IN THE CLINIC NOTABLY FOR
ENDOCRINE AND METASTATIC CANCER,
HOWEVER THE PRE-CLINICAL SPACE
IS QUITE LIMITED AND THINS OUT
AT BASE OF THE FIGURE.
ON THE RIGHT WE EMPHASIZE THAT
DEVELOPMENT AND PHARMA IS ALSO
LIMITED FOCUS ON MONOTHERAPIES
AND RPG TRIAL PROPOSALS RELY ON
EMPIRICAL DATA.
THE NCI RESEARCH PORTFOLIO RPT
IS COMPRISED OF 20 AWARDS,
FOCUSED ON THERAPEUTIC OR
IMAGING BASE OBJECTIVES, THERE'S
MINIMAL SUPPORT TOWARD
UNDERSTANDING RADIO BIOLOGY OF
RPT.
WE CALL THAT THE UNDERLYING
PREMISE OF RPT TO TUMOR BIOLOGY.
NEXT SLIDE PLEASE.
THEREFORE UNMET NEEDS AND
FOUNDATION PRE-CLINICAL RPT
RESEARCH STEM FROM DERTH OF RPT
STUDIES THAT LEVERAGE ADVANCE
OMICS CANCER MODELING ENABLING
CELL BIOLOGY TECHNOLOGIES, GAPS
NOTED BY RECENT CTAC RADIATION
ONTOLOGY WORKING GROUP REPORT.
SPECIALIZED EXPERTISE IN
LICENSURE FOR RAID YES NUCLIDE
USE CAN CREATE A THRESHOLD INTO
ALREADYPT RESEARCH, HAVING A
EFFECT ON RADIO BIOLOGISTS AND
CANCER BIOLOGISTS IN THE
PRE-CLINICAL SPACE.
NEXT SLIDE PLEASE.
TO ADDRESS THIS THE OBJECTIVE
ARCHIVE CATALYZE COLLABORATIVE
PROJECTS AS DEPICT MISDEMEANOR
THE UPPER RIGHT STRENGTHEN THE
PRE-CLINICAL FOUNDATION OF THE
RPT FIELD, THE STRIPE DAR
FACILITATE INTEGRATION OF RPT
INTO PRE-CLINICAL ORIENTED TUMOR
BIOLOGY EXPERIMENTS WITH HAVING
POTENTIAL TO IDENTIFY NEW
TARGETING STRATEGIES, AND
CONDUCT A MORE SYSTEMATIC
EXAMINATION OF DRUG RPT
COMBINATIONS.
NEXT SLIDE PLEASE.
WE PROPOSE USING PAR MECHANISM
TO SOLICIT RO1 AND R21
APPLICATIONS, WE WILL ENCOURAGE
COLLABORATIVE PROJECTS THAT
INTERSECT RPT AND PRE-CLINICAL
CANCER BIOLOGY.
úRAID YEAR AGO THERAPEUTICS AND
BIOLOGY STUDY SECTION AND
ENUMERATES HOW THEY REVIEW ABOUT
225 UNSOLICITED APPLICATIONS PER
YEAR.
ONLY A HANDFUL OF RPT RESEARCH
AWARDS MADE A YEAR.
NUCLEIC TO PORTFOLIO AND
CATALYZE A FIELD POISED FOR
IMPACT CANCER THERAPY IN NEW
WAYS.
NEXT SLIDE PLEASE.
THIS IS A FINAL SLIDE.
IN SUMMATION RPT TOOLBOX EXISTS
WITH DEMONSTRABLE SUCCESS IN
CLINIC.
THE BSA SUBCOMMITTEE ASKED US TO
EMPHASIZE THE FOLLOWING PAR CON
SUSPECT ADDRESS THE NEED TO
BOLSTER PRE-CLINICAL FOUNDATION
OF RPT AND RADIO BIOLOGY
RESEARCH WITH GOAL EXPANDING
DIVERSIFYING THE FIELD.
TO BE SPECIFIC ABOUT WHAT WOULD
SUCCESS LOOK LIKE, WE SEEK TO
ESTABLISH THE PORTFOLIO OF 6 TO
8 AWARDS FOCUSED ON BIOLOGY
BASED RPD TARGETING.
WHERE THESE DATA WOULD HAVE
POTENTIAL TO INFORM RATIONALE
FOR NEW CLINICAL TRIALS
CONCEPTS.
POSSIBLY EMERGING INTEREST IN ET
CTN TRIALS.
THANK YOU VERY MUCH.
>> THANK YOU VERY MUCH.
KAREN, COULD YOU LEAD US OFF IN
DISCUSSION.
>> GET US STARTED I WILL BE
BRIEF BECAUSE THERE WAS
SIGNIFICANT ENTHUSIASM FOR THIS
PAR.
DESPITE ADVANCES INCLUDING BUT
NOT LIMITED TO PSMA SUCCESS IN
PROSTATE CANCER, THERE'S A
UNDERFUNDING AS YOU SAW OF RADIO
PHARMACEUTICAL GRANTS IN
TRADITIONAL STUDY SECTIONS SO WE
PLOTTED THE -- APPLAUDED EFFORT
OF DR. ESPE AND GROUP TO PUT
TOGETHER A WELL CRAFTED PAR
CENTERED ON THIS FOUNDATIONAL
PRE-CLINICAL KNOWLEDGE WITH THE
GOAL TWOFOLD GOAL OF BRINGING TO
BEAR NEW POTENTIAL AGENTS IN THE
PRE-CLINICAL SPACE TO ULTIMATELY
GO TO THE PIPELINE BUT ALSO NEW
COMBINATIONS, THE QUESTIONS THAT
WE HAVE WHICH I THINK WERE
SATISFACTORILY ADDRESSED IN THE
PRESENTATION BUT ALSO IN OUR
MEETING, WENT TOWARD ENSURING
THAT WE HAD THE RIGHT REVIEWERS
IN THE POOL WITH THE RIGHT
COMPETENCY AND STUDY SECTION TO
ASSESS THE SCIENCE AND WE FEEL
CONFIDENT THE PROGRAM HADNA MIND
ALREADY.
SO I WILL -- THAT IN MIND
ALREADY.
I'M HIGHLY SUPPORTIVE OF THIS,
THIS IS AN IMPORTANT NEW AREA,
FOR WHICH I THINK WE NEED INT TO INCREASE
THE PACE OF DISCOVERY.
I WILL ASK THE DOCTORS IF THEY
HAVE MORE TO ADD.
>> IN THE INTEREST OF TIME I
DON'T HAVE ANYTHING ELSE TO ADD.
KAREN SUMMARIZED IT WET.
>> I ECHO THAT I HAVE
SUPPORTIVE, I THINK ESPECIALLY
BRINGING PHARMACEUTICAL
SCIENTISTS TOGETHER IS
ABSOLUTELY NEEDED.
>> WE CLASSIFIED THIS AS A NO
BRAINER.
>> EXCELLENT.
ANY FURTHER BRIEF DISCUSSION?
QUESTIONS OR COMMENTS?
HEARING NONE LET'S MOVE TO
VOTING.
KAREN WOULD YOU MAKE A MOTION?
>> LIKE TO MAKE A MOTION TO FILL
IN THE CORRECT VERB APPROVE.
>> APPROVE.
>> EXCELLENT.
THANK YOU.
ANY FURTHER DISCUSSION?
OKAY.
MOTION ON THE TABLE IS TO
APPROVE ANY BSA MEMBERS
DISAPPROVE PLEASE VOICE THAT
VOTE BY RAISING YOUR HAND.
SEEING NONE, ANY ABSTENTIONS,
PAULETTE I'M GOING TO ABSTAIN
FROM THIS VOTE.
ANY OTHER ABSTENTION?
>> OKAY.
SO WE HAVE ONE ABSTENTION.
>> CORRECT.
OTHERWISE UNANIMOUS.
>> OKAY.
>> THANK YOU.
>> AND THAT WRAPS UP OUR CONCEPT
REVIEW TODAY.
>> NO IT DOESN'T.
ONE MORE CONCEPT.
>> IF I DON'T SEE RED I LOOK TO
JOHN TO TAKE OVER.
ONE MORE CONCEPT.
SORRY.
IF YOU WANT TO TAKE A TEN MINUTE
BREAK OR YOU CAN GO AND COME
BACK AND SO LET'S JUST KEEP
GOING.
IF THERE'S ANYONE WHO DISAGREES
WITH THAT, SAY NO.
>> PAULETTE, I DO HAVE ONE
QUESTION BEING NEW AT THIS.
IF YOU ARE INVOLVED WITH A
PROGRAM TO BE DISCUSSED THROUGH
A PROPOSAL AS INVESTIGATOR,
SHOULD I STEP OFF CALL OR WHAT
IS MY CONFLICT SITUATION THERE?
>> OKAY.
IS THIS TRAY?
>> THIS IS TREY.
>> I SENT YOU AN EMAIL A TAD
EARLIER TODAY.
>> I'M SORRY
>> I MISSED IT.
>> YOU DON'T HAVE TO LEAVE BUT
YOU SHOULD NOT PARTICIPATE IN
THE DISCUSSION.
ONCE YOU ARE FULLY APPOINTED YOU
CANNOT VOTE SO TODAY ALL I NEED
YOU TO DO IS SIT TIGHT.
>> WILL DO.
THANK YOU.
>> BACK TO BUSINESS, FINAL
CONCEPT.
IS A REISSUE RFA ENTITLED
INFORMATICS TECHNOLOGY FOR
CANCER RESEARCH, PRESENTED BY
DR. JULIE KLEMM, SUBCOMMITTEE IS
CHAIRED BY SILL VIEIA AND
SUPPORTED BY MIKE AND LISA.
>> THANK YOU FOR THIS
OPPORTUNITY TO PRESENT OUR
REQUEST TO REISSUE RFAs FOR
THE NCI'S INFORMATICS TECHNOLOGY
FOR CANCER RESEARCH PROGRAM.
IPCR IS A TRANSNCI PROGRAM TO
SUPPORT INVESTIGATOR INITIATED
INFORMATICS TECHNOLOGY
DEVELOPMENT DETERMINED BY
CRITICAL NEEDS IN CANCER
RESEARCH.
THE FUNDED PROJECTS SUPPORT A
RANGE OF CANCER RESEARCH
ACTIVITIES.
ALL TOOLS DEVELOPED ARE OPEN
SOURCE AND PROGRAMMATIC
ACTIVITIES PROMOTE
INTEROPERABILITY AND
DISSEMINATION OF SUPPORTED
TOOLS.
THE PROGRAM STRUCTURE SUPPORTS
ACTIVITY ACROSS THE INFORMATICS
DEVELOPMENT LIFE CYCLE THROUGH
COMPANION FUNDING OPPORTUNITIES.
FOUR RFAs SUPPORT INFORMATICS
TECHNOLOGY DEVELOPMENT.
AN R21 SUPPORTS DEVELOPMENT OF
INNOVATIVE METHODS AND
ALGORITHMS THE UO 1 SUPPORTS
EARLY STAGE TOOL DEVELOPMENT,
THE ADVANCE DEVELOPMENT U 24
SUPPORTS ENHANCEMENT AND
DISSEMINATION OF EMERGING
INFORMATICS TOOLS AND THE
SUSTAINMENTED U 24 SUPPORTS
ACCESSED MATURE INFORMATICS
RESOURCES.
THE UO 1 AND U 24 AWARDEES ARE
REQUIRED TO SET ASIDE 10% OF
ANNUAL BUDGET FOR COLLABORATIVE
ACTIVITIES.
THAT ARE PROPOSED POST AWARD.
IN ADDITION THE PROGRAM HAS A
NEW EDUCATION RESOURCE ADDED AT
THE LAST PROGRAM RENEWAL, TO
CONDUCT ACTIVITIES THAT ENGAGE
RESEARCH AND INFORMATICS
COMMUNITY TO USE AND EXTEND ITCR
TECHNOLOGIES.
THE PROGRAM OFFERED SERIES OF
COMPETITIVE REVISION TO SUPPORT
THE INCORPORATION OF ITCR FUNDED
TECHNOLOGY AND RO1 UO 1 AND U 24
PROJECTS.
SINCE THE INCEPTION IN 2013 ITCR
HAS IMPORTANT ESTABLISHMENTS IN
SEVERAL AREAS -- ACCOMPLISHMENTS
IN SEVERAL AREAS.
TOOLS SUPPORTING THE PROGRAM ARE
WIDELY USED INFORMATICS
RESOURCES IN CANCER RESEARCH
EVIDENCED BY CITATION AND USAGE
STATISTICS.
THIS TABLE SHOWS A FEW EXAMPLES
ACROSS VARIOUS RESEARCH DOMAINS
OF WIDELY USED RESOURCES
SUPPORTED THROUGH THE PROGRAM.
ITCR TOOLS SUPPORT IMPORTANT
ADVANCE ACROSS CANCER RESEARCH
CONTINUUM AND MANY OF THESE
ACTIVITIES ARE DIRECT SUPPORT OF
NCI SCIENTIFIC PROGRAMS.
THE PROGRAM IS FOSTERING
COMMUNITY OF PRACTICE IN CANCER
INFORMATICS THROUGH PROGRAMMATIC
EMPHASIS ON COLLABORATION AND
INTEROPERABILITY THAT SUPPORT
THROUGH THE SET ASIDES FUNDS.
FINALLY ITCR TOOLS HAVE HIGH
ADOPTION AND CITATION RATES
THROUGH EMPHASIS ON OUTREACH AND
TRAINING.
NEXT SLIDE PLEASE.
SINCE THE START OF THE PROGRAM
ITCR MADE 130 AWARDS AND THE
PORTFOLIO INCLUDES TOOLS THAT
SUPPORT WIDE RANGE OF DATA TYPES
REPRESENTED IN THIS TREE PLOT.
SOME OF THE MOST PROMINENT
TECHNOLOGIES TO SUPPORT
RADIOLOGY IMAGING MEDICAL INFOR
MA THEICS, GENOMICS AND
HISTOLOGY.
NEXT SLIDE.
THESE TOOLS SUPPORT VARIETY OF
DATA SCIENCE FUNCTIONS INCLUDING
DATA MANAGEMENT, VISUALIZATION
STATISTICAL AND MACHINE LEARNING
METHODS NATURAL LANGUAGE
PROCESSING, CLINICAL DECISION
SUPPORT, CLINICAL TRIALS
MATCHING.
NEXT SLIDE PLEASE.
THE PROGRAM MAINTAINS A CATALOG
OF ALL ITCR SUPPORTED TOOLS ON
THEIR WEBSITE THAT INCLUDE
POINTERS TO THE PROJECT WEBSITE,
CODE REPOSITORIES RUNNING
INSTANCES OF THE TOOLS, AND FOR
MANY SHORT EXPLAINER VIDEOS WITH
OVERVIEW OF THE TOOLS FUNDALTY.
NEXT SLIDE PLEASE.
TODAY COLLABORATIVE SET ASIDE
FUNDS SUPPORTED 50
COLLABORATIONS, MOST WHICH
BETWEEN ITCR SUPPORTED TOOLS AND
THIS IS FOSTERING THE EMERGENCE
OF ECOSYSTEM OF CANCER
INFORMATICS RESOURCES THAT
DEPICTED IN THIS NET WORK
DIAGRAM, IT WAS CONNECTIONS AND
COLLABORATION BETWEEN ITCR
TOOLS.
NEXT SLIDE PLEASE.
TO DISSEMINATE INFORMATION ABOUT
AVAILABILITY AND EXTENSIBILITY
OF ITCR TOOLS AN RESOURCES THE
INVESTIGATORS CONDUCT OUTREACH
AND TRAINING AND SUPPORTED
FUNDED TECHNOLOGY.
IN ADDITION TO THE ACTIVITIES
THAT ARE CONDUCTED WITHIN THE
INDIVIDUAL AWARDS ITCR TOOLS ARE
PROMOTED THROUGH PROGRAM WIDE
EFFORTS BEEN SPURRED THROUGH
TRAINING AND OUTREACH WORKING
GROUP.
THIS INCLUDED TWO FOCUS JOURNAL
ISSUES OF TECHNOLOGIES DEVELOPED
THROUGH THE PROGRAM, THE MOST
RECENT BEING FOCUS ISSUE OF JCO
CLINICAL CANCER INFORMATICS
WHICH TECH PEER REVIEW PAPERS
OF OVER 30 ITCR TOOLS AND
PROMOTED ITCR RESOURCES THROUGH
DEDICATED SECTIONS AT PROMINENT
SCIENTIFIC CONFERENCES, REGULAR
PARTICIPATION AND VARIOUS NCI
WEBINAR SERIES, AND THROUGH
SOCIAL MEDIA.
NEXT SLIDE PLEASE.
BASED ON THE EVALUATION
RECOMMENDATION FROM OUR 2018
RENEWAL, THE PROGRAM IS ADDED A
UA 5 EDUCATION RESOURCE WITH TWO
PRIMARY GOALS, TO PROVIDE IN
DEPTH COURSES ON TOPICS AND
CANCER INFORMATICS USING THE
ITCR TOOLS AS EXEMPLARS AND
PROVIDE GUIDANCE AND SUPPORT TO
INFORMATICS TOOL DEVELOPERS TO
FACILITATE DISSEMINATION OF BEST
PRACTICES FOR USER ENGAGEMENT
AND OUTREACH.
JOHNS HOPKINS UNIVERSITY
RECEIVED THIS AWARD IN SEPTEMBER
2020 AND HAS INITIATED THE ITCR
TRAINING NETWORK AND THE ITN
RELEASED MY COURSES LEADERSHIP
PER CANCER INFORMATICS RESEARCH
AND DOCUMENTATION AND USABILITY
WITH OTHERS BEING ROLLED OUT
ACROSS THE PERIOD OF AWARD.
IN PREPARATION FOR REQUESTING
THIS RENEWAL AND EVALUATION OF
ITCR PROGRAM WAS CONDUCTED IN
EARLY 2021, THIS REVIEW WAS LED
BY PANEL OF SCIENTISTS FROM THE
EXTRAMURAL COMMUNITY WITH
EXPERIENCE IN CANCER INFORMATICS
DEVELOPMENT.
THEIR FINDINGS WERE
OVERWHELMINGLY POSITIVE WITH
OVERALL RECOMMENDATION TO
CONTINUE THE PROGRAM AS
STRUCTURED.
ADDITIONAL RECOMMENDATIONS
INCLUDED CONTINUING TO PROMOTE
CLAN RATION AMONG TOOL
DEVELOPERS AND EMPHASIZE FUNDING
EMERGING TECHNOLOGIES TO KEEP
PACE WITH ADVANCE IN CANCER
RESEARCH.
OPINIONLY THE PANEL RECOMMENDED
THE PROGRAM MAXIMIZE THE VALUE
OF THE TECHNOLOGIES BY PROMOTING
INFORMATICS SKILL AND WORK FORCE
DEVELOPMENT, ADVANCING STANDARDS
DEVELOPMENT EVALUATION AND
DISSEMINATION OF TOOLS,
FOSTERING ACADEMIC INDUSTRY
PARTNERSHIPS AND WORKING TO
ENSURE TOOLS AND ALGORITHMS ARE
AT THE GOAL AND TRANS-- ETHICAL
AND TRANSPARENT.
BASED ON FINDINGS OF THE
EVALUATION PANEL AND PROGRA
IMPACT TO DATE WE PROPOSE TO
CONTINUE ITCR AS A TRANSNCI
PROGRAM IN SUPPORTIVE INNOVATIVE
INVESTIGATOR INITIATED RESEARCH
DRIVEN INFORMATICS TECHNOLOGY
DEVELOPMENT TO MEET OBJECTIVES
WE WILL CONTINUE TO EMPLOY A
MULTI-MECHANISM APPROACH TO
SUPPORT INFORMATICS TECHNOLOGY
DEVELOPMENT THROUGH THE USE OF
THE R21 UO 1 AND U 24
MECHANISMS.
WE PROPOSE TO CONTINUE TO MAKE
THE FOA CLINICAL TRIALS OPTIONAL
TO SUPPORT TECHNOLOGY VALIDATION
STUDIES THAT MEET NIH DEFINITION
OF CLINICAL TRIAL.
TO ADDRESS FEEDBACK FROM THE
EVALUATION PANEL REGARDING
RELATIVE EMPHASIS ON NEW EARLY
STAGE DEVELOPMENT THE ITCR
PROGRAM TODAY OPTIMIZE PROCESSES
TO PRIORITIZE MERITORIOUS UO 1
APPLICATIONS FOR INCLUSION AND
FUNDING PLANS AND PROMOTE
ACADEMIC SRI PARTNERSHIPS SBIR
WILL BE ENGAGED TO IDENTIFY
OPPORTUNITIES FOR COLLABORATION
WITH INDUSTRIAL PARTNERS FOR
DIRECTED YOU OUT REACH AND FOCUS
CONTRACT TOPICS.
WE ARE NOT PROPOSING TO RENEW
THE COMPETITIVE -- COMPETING
REVISIONS FOR THE ADOPTION OF
ITCR TECHNOLOGIES THAT WERE
INITIATE IN THE PREVIOUS
RENEWAL.
DUE TO LOW RESPONSE RATE TO
FOAs.
ADOPTION OF THE ITCR TOOLS WILL
CONTINUE TO BE VIGOROUSLY
PROMOTED THROUGH INVESTIGATOR
PROMOTED OUTREACH ACTIVITIES.
NEXT SLIDE.
THE BUDGET REQUESTING IS 8
MILLION PER YEAR FOR NEW AWARDS
AND WE ARE REQUESTING THREE
REISSUANCES THE ESTIMATED
DISTRIBUTION ACROSS MECHANISMS
AD SHOWN ON THE SLIDE.
NEXT SLIDE.
I WOULD LIKE TO THANK THE
SUBCOMMITTEE WHO REVIEWED THE
REQUEST FOR FEEDBACK AND
VALUABLE DISCUSSION.
FEEDBACK INCLUDED FURTHER
PRIORITIZING CONSIDERATIONS FOR
SUSTAINMENT OF THE ITCR
TECHNOLOGIES, WE DISCUSSED
SEVERAL MODELS FOR SUSTAINMENT
INCLUDING SUCCESSFUL COMPETITION
FOR CONTINUED NCI FUNDING,
COMMERCIALIZATION OR OTHER
INDUSTRY PARTNERSHIP AS WELL AS
FUNDING THROUGH OTHER SOURCES
INCLUDING POSSIBLE CLINICAL
TRIALS FOR MATURE TOOLS.
LIKE THE EVALUATION PANEL THE
BSA REVIEWERS RECOMMENDED
FOSTERING INDUSTRIAL
PARTNERSHIPS AND WHILE SEVERAL
INDIVIDUAL PROJECTS DO HAVE
INDUSTRY PARTNERS AS MENTION WE
DO PLAN TO PROGRAMATICALLY
ENGAGE WITH SBIR.
THE REVIEWERS NOTED THE
IMPORTANCE OF CONTINUING TO
ENSURE THAT ITCR SUPPORTED
DIVERSE AREAS OF CANCER RESEARCH
AND RECOMMENDED INCREASING THE
NUMBER OF CLINICAL TRANSLATIONAL
TOOLS IN THE PORTFOLIO.
WE DO RECOGNIZE THERE ARE
UNDER-REPRESENTED DOMAINS IN THE
PORTFOLIO AND MOST RECENTLY
WORKED WITH COLLEAGUES IN DCCPS
TO PUT UP RFI FOR MORE INPUT ON
TECHNOLOGY NEEDS FOR
EPIDEMIOLOGY AND POPULATION
RESEARCH TO INFORM FUTURE
RFAs.
FINALLY THE SUBCOMMITTEE
EMPHASIZED THE IMPORTANCE OF
INCREASING ENGAGEMENT WITH OTHER
NCI PROGRAMS.
NEXT SLIDE PLEASE.
WHEN WE LOOK ACROSS NCI
CONSORTIA WE SEE ITCR TECHNOLOGY
SUPPORTING RESEARCH WITHIN THESE
PROGRAMS AND THIS SLIDE SHOWS
SEVERAL EXAMPLES.
GOING FORWARD WE PLAN TO
INCREASE CANCER OUTREACH TO NCI
CONSORTIA AND CANCER CENTER.
NEXT SLIDE.
FINALLY I WOULD LIKE TO END BY
ACKNOWLEDGING THE NCI STAFF ON
ITCR PROGRAM TEAM THAT SUPPORTS
THIS TRANSNCI PROGRAM WHO I
REPRESENT TODAY.
WITH THAT I WOULD LIKE TO THANK
YOU AND I'M HAPPY TO TAKE ANY
QUESTIONS.
OPERATOR: THANK YOU VERY MUCH
DR. KLEMM.
SYLVIA, LEAD THE DISCUSSION.
>> THANK YOU, DR. KLEMM FOR A
TERRIFIC PRESENTATION, MICHAEL
IAN AND I SERVE ON THE COMMITTEE
AND THIS IS REALLY EXCEPTIONAL
PROGRAM AND WE ARE UNANIMOUSLY
SUPPORT OF RENEWALS GOING
THROUGH DISCUSSION.
WE FELT A PRESENTATION VALUABLE
TO ENSURE THE BSA AND NCAB
MEMBERS ARE AWARE REMARKABLE
SUCCESS OF THIS PROGRAM.
WE HAD REALLY PRODUCTIVE HOUR
LONG MEETING WITH JULIE AND SHE
ITEMIZED DISCUSSION POINTS
REALLY AROUND PATHS OF LONG TERM
SUSTAINABILITY AND THE ITCR
FUNDED PROGRAMS INCREASE
PARTNERSHIPS WITH INDUSTRY,
INCREASE INTERACTION WITH OTHER
NCI PROGRAMS SPECIFICALLY TOWARD
SPORES AND CRSG TO HAVE MORE
EXPLICIT CONNECTION WITH ITCR.
AND TO EXPAND THE CLINICAL
TRANSLATIONAL INFORMATICS IN THE
ITCR PORTFOLIO WITH CLINICAL
PHENOTYPING.
IN CONCERT WITH CC SGAs SO
JUST VERY IN SUMMARY WE ARE VERY
SUPPORTIVE WE VIEW AS IMPORTANT
ASSET OF THE NCI AND PLACE FOR
CONTINUED INVESTMENT TO KEEP
PACE WITH ADVANCES IN DATA
SCIENCE.
THIS -- I WOULD LIKE TO INVITE
MY COLLEAGUE DR. BESICH.
>> GREAT SUMMARY.
IT IS A MODEL PROGRAM FOR THE
ENTIRE NIH WHERE IT COULD MOVE
TO EXCEPTIONAL FOR THE INFINITY
WOULD BE TO INTEGRATE MORE
DEEPLY WITH KEY NCI PROGRAMS
STILL TO ME IS LACKING SOME KIND
OF PRESCRIPTIVE PATH FOR ITCR TO
INTERACT WITH SPORES, TO
INTERACT WITH OTHER U 54
MECHANISMS WITH PROGRAM
PROJECTS, WITH SPORES WOULD BE
AN EXCEPTIONAL OLD STEP FORWARD
FOR THE NCI IN NOT TO BE SO
PRESCRIPTIVE TO MAKE SURE THAT
THAT HAPPENS.
I THINK BARRIER TO SUCCESS SO
THIS IS IS A MODEL PROGRAM
TESTIFY IN THELY REFUNDED AND
KUDOS TO JULIE AND CODER SHIP
BUT DEEPER INTEGRATION WITH
ITSELF NCI TAKE IT TO THE NEXT
LEVEL.
>> -- IS NOT HERE TODAY.
>> OPEN UP ANY FURTHER QUESTIONS
OR COMMENTS FROM MEMBERS?
>> THIS IS JOHN I ALSO THINK
THIS PROGRAM IS WELL SHUTEDDED
FOR CONSIDERING INTEGRATING WITH
-- PARTICULARLY ON THE TRAINING
SIDE, THINK ABOUT
UNDER-REPRESENTED MINORITY
TRAINEES I HAVE ALWAYS LOOKED AT
DATA SCIENCE AND INFORMATICS
WELL SUITED ESPECIALLY THINK
ABOUT FOR INSTANCE MINORITY
SERVING INSTITUTIONS, MIGHT NOT
BE A LOT OF INFRASTRUCTURE FOR
WET LAB RESEARCH BUT THERE COULD
BE A LOT OF INFRASTRUCTURE IN
PLACE FOR DRY LAB WORK A LOT
DONE IN THE CLOUD SO IT WOULD BE
GREAT TO SEE HOW YOU COULD WORK
TO ENHANCE TRAINING.
AROUND BIOINFORMATICS AN DATA
SCIENCE IN THOSE SETTINGS.
>> THE OPPORTUNITY TO MENTION
THE EDUCATION RESOURCE HAS
PARTICULAR FOCUS ON WORKING WITH
MINORITY SUPPORTING
INSTITUTIONS.
AND HAS PARTICULAR AIM AROUND
THAT.
>> OPPORTUNITY IS GROWING R 25
PROGRAM IN NCI SUPPLEMENTS, TO
BRING UNDER-REPRESENTED
MINORITIES IN TO STEM WITH TWO
Ms, SCIENCE TECHNOLOGY
ENGINEERING MATH AND MEDICINE TO
CANCER RESEARCH AND AGAIN IT IS
PLACE WHERE ITCR IS SILENT BUT
YOU SHOULD BE ENCOURAGED BECAUSE
YOU NEED TO START EARLY AT THIS
STAGE OF RECRUITING
UNDER-REPRESENTED SCIENCE --
SCIENTISTS WITH POTENTIAL INTO
THE FRAMEWORK.
WE HAD EXTRAORDINARY SUCCESS
WITH OUR R 25 DOING THAT THOUGH
NO LONGER ITCR FUNDED.
ANOTHER MISSED OPPORTUNITY TO
INTEGRATE PROGRAMS ACROSS THENY
THAT ITCR SHOULD BE ENCOURAGED
AND FUNDED.
>> COUPLE OF GOOD COMMENTS IN
TERMS OF POSSIBLE INTERACTION
WITH N CORP, ALSO A SUGGESTION
TO CONSIDER.
LET'S MOVE TO VOTING.
SYLVIA, MAKE A MOTION LOOKING
FOR CONCURRENCE OR
NON-CONCURRENCE.
>> I CONDITION CUR.
>> CAN I GET A SECOND -- CONCUR.
>> I'LL SECOND THAT STRONGLY.
>> THANK YOU.
ANY FURTHER DISCUSSION?
NO?
MOTION IS FOR CONCURRENCE.
BSA MEMBERS IF YOU VOTE TO NOT
CONCUR PLEASE VOICE THAT OR
RAISE YOUR HANDS.
I SEE NONE.
ANY ABSTENTIONS.
NO ABSTENTIONS,
>> IT'S UNANIMOUS NO
ABSTENTIONS.
WE ARE FINISHED WITH THE CONCEPT
CLEARANCES.
>> GREAT, JOHN BACK TO YOU.
>> SO I THINK WE NEXT ON THE
AGENDA IS ONGOING BUSINESS.
THERE WAS ONE NCAB SUBCOMMITTEE
MEETING ON DECEMBER 7 WHICH WAS
AD HOC SUBCOMMITTEE ON
EXPERIMENTAL THERAPEUTICS WHICH
IS CHAIRED BY TIM WADE.
SO I BELIEVE TIM WILL GIVE A
REPORT.
>> POINT OF ORDER, AT THE END OF
THE REPORT PAULETTE WE NEED A
MOTION A SECOND AND VOTE TO
APPROVE THIS MOTION.
>> THE BOARD WILL VOTE TO ACCEPT
THE REPORT.
JOHN --
>> ONLY NCAB.
ONLY NCAB MEMBERS WILL VOTE.
(OVERLAPPING SPEAKERS)
>> YES.
>> STILL HAVE A QUORUM.
>> YES, WE DO.
>> I SERVED ON THE BOARD, BEEN A
TREMENDOUS PLEASURE FOR SEVEN
AND A HALF YEARS.
I WILL TELL YOU THE ONLY THING
BETWEEN ME AND THE END OF MY
SERVICE TO THE BOARD THIS
REPORT.
I ASSURE YOU I'M GOING TO BE
SUCCINCT.
ABOUT YEAR AND A HALF AGO NED
ASKED ME TO CHAIR A SUBCOMMITTEE
ON EXPERIMENTAL THERAPEUTICS TO
GIVE ADVICE NCI HEEDER SHIP
ABOUT TOPICS THAT WERE HOT AND
THAT THE NCI IMMEDIATED TO
CONSIDER FOR BOARD MEMBERS TO
FOCUS ON THINGS THAT WOULD BE
RELEVANT FOR NCI INVESTMENT IN
THE NEAR FUTURE.
SO THE SUBCOMMITTEE MET AND
CONSIDERED A WIDE VARIETY OF
TOPICS AND WE PICKED TWO.
CELLULAR THERAPY, AND RATIONAL
DRUG DESIGN TO ADDRESS.
WE DID NOT HAVE ADEQUATE
EXPERTISE TO THE BOARD TO
EXPRESS IN A MEANINGFUL WAY SO
THEREFORE NCI STAFF PARTICULARLY
ROSE OR JENNA, EXECUTIVE
SECRETARY OF THE SUBCOMMITTEE,S
ORGANIZED WORKSHOPS FOR US TO
GATHER INFORMATION ABOUT THESE
TWO TOPICS.
SO THERE WERE TWO THAT WERE DONE
IN CELL THERAPY INCREDIBLY
VALUABLE IT WAS REASONABLY VAGUE
FORWARD TO GET PEOPLE'S IDEAS
ABOUT ISSUES INVOLVED IN
CELLULAR THERAPY FOR CANCER AND
THOSE WORKSHOPS LED TO REPORT
WITH SEVEN RECOMMENDATIONS WE
OFFER TO THE BOARD AND WERE
APPROVED EARLIER I YEAR.
THE SECOND TOPIC RATIONAL DRUG
DESIGN TURNED OUT MUCH, MUCH
MORE DIFFICULT.
IT IS A VERY, VERY LARGE AREA.
AGAIN WE DIDN'T HAVE ADEQUATE
EXPERTISE ON THE BOARD TO
EXPLORE THIS IN DETAIL.
SO ROSE AND HER COLLEAGUES AT
NCI WORKSHOP THAT WAS HELD ON
THE 18TH AND 19TH OF OCTOBER,
RASH MALL DRUG DESIGN, OVER 700
PEOPLE PARTICIPATED IN THE WORK
SHOPS AND NUMBER VERY PROMINENT
LEADERS IN THIS ARENA INCLUDING
LEADERS IN PHARMA PARTICIPATED.
THEY CONSIDER FOUR TOPICS
VIRTUAL BIOLOGY AND RELEVANCE OF
CRYOEM FOR THAT KIND OF
TECHNOLOGY FOR DRUG DESIGN, THEY
CONSIDERED MACHINE LEARNING
ARTIFICIAL INTELLIGENCE IN ITS
ROLE NOVEL MODALITIES FOR
EXPLORING RATIONAL DRUG DESIGN
AND TARGETED INTERROGATION.
THEY CAME UP WITH A LARGE NUMBER
OF IDEAS WHICH I WILL ATTEMPT TO
DISTILL INCREDIBLY BRIEFLY FOR
YOU THE NEXT COUPLE OF MINUTES.
THE OVERARCHING THEMES ABOUT
AREAS THAT WERE PROBLEMATIC IN
THIS ARENA WERE AS FOLLOWS.
SO NUMBER ONE WAS DATA SHARING
AND HOMAGE ANYIZATION.
THIS IS SEEN AS AN OBSTACLE IN
MANY WAYS, ESPECIALLY AS
PERTAINS TO DEVELOPING DATABASES
THAT CAN BE UTILIZED BY
ARTIFICIAL INTELLIGENCE MACHINE
LEARNING AL FOR RUT.
S THAT QUALITY OF DATA SETS AND
THE HARMONIZATION OF DATA SETS
IS ABSOLUTELY ESSENTIAL FOR
BEING EFFECTIVE IN TERMS OF
USING EXISTING DATA TO LOOK AT
RATIONAL DRUG DESIGN.
THE SECOND THING THAT WAS
ENORMOUS WAS REPRODUCIBILITY OF
STUDIES, REPRODUCIBILITY CRISIS
HOW THAT CAN BE ADDRESSED.
THIRD WAS THE UNIFICATION OF
INVESTIGATORS ON BOTH SIDES OF
THE STREET AND ACADEMIA AND
PHARMA.
THE LAST WAS THIS LONG STANDING
DILEMMA OF HOW TO GET AN IDEA TO
A PRODUCT, SO CALLED VALLEY OF
DEATH OF DRUG DEVELOPMENT
BETWEEN DISCOVERY OF LEAD
COMPOUNDS AND INITIAL TRIAL
DRUGS, GETTING SOMETHING TO
APPROVAL BY THE FDA.
THOSE ARE THE MAJOR THEMES
IDENTIFIED BY PARTICIPANTS IN
THESE WORKSHOP GROUPS, THERE WAS
SOME RECOMMENDATIONS THAT CAME
OUT WHICH I WILL SUMMARIZE FROM
A LOFT HERE THAT ARE RELEVANT
FROM THE NCI LEADERSHIP.
MAJOR CATEGORIES WERE TO REALLY
HI SERIOUSLY ABOUT NON-DRUGGABLE
TARGETS AND DEVELOP MECHANISMS
FOR EVALUATING NON-DRUGGABLE
TARGETS.
TO DEVELOP BETTER RESOURCES FOR
MEDICINAL CHEMISTRY COURSE.
TO INCREASE ACCESSIBILITY OF
LIBRARIES IN THE NEXT PROGRAM
AND CRYOEM SOMEWHAT LIMITED IN
MANY INSTITUTIONS BUT RESOURCES
AT THE NATIONAL LAB IN PREED
RICK ARFREDERICKARE EXTENSIVE BUT OVERSAW SCRIBE
BUT WE NEED MORE LEVEL OF DATA
ABOUT LEVEL OF RESOURCES
AVAILABLE.
BETTER DEVELOPMENT OF MODEL LIKE
PDX AND APPROACHES FOR TARGETED
VALIDATION WHICH ARE KEY TO
MAKING SURE DRUG TARGETS ARE
GOING TO BE USEFUL AT THE END OF
THE DAY.
BETTER ACCESSIBILITY OF DNA
ENCODED LIBRARIES AND FRAGMENT
BASE DRUG DESIGN WHICH NOW ARE
NOT REALLY SOURCES OF RESOURCES
THAT ARE SUPPORTED BY THE NCI.
ONE THING THAT I THINK EVERYBODY
WAS CONCERNED ABOUT IS TRAINING
OF PEOPLE IN THIS DISMINUTE.
IF SOMETHING WERE INSTEAD OF
TRAINING OF YOUNG PEOPLE BEING
ACCENTUATED RECENTLY DECLINED,
MANY MEDICAL SCHOOLS HAVE SHIED
AWAY FROM DRUG DEVELOPMENT AND
FROM DEPARTMENTS OF
PHARMACOLOGY.
AND MANY YOUNG SCIENTISTS AND
PHYSICIAN SCIENTISTS ARE NOT
TRAINED IN THIS DISCIPLINE ANY
MORE THERE WAS A STRONG FEELING
THAT TRAINING IN THE NURTUREK OF
PEOPLE WHO ARE INTERESTED IN
THESE IDEAS IS INTERNAL MISSING
FEATURE OF THE CURRENT LANDSCAPE
AND SINCE THERE'S NO PRECEDENT
FOR THIS VERY CAREFUL THOUGHT
HOW TO DEVELOP THESE KINDS OF
TRAINING EXERCISES ARE GOING TO
BE NEEDED.
ALONG THOSE LINES AN IMPORTANT
ADDITIONAL IDEA IS THAT THESE
CONCEPTS REQUIRE TEAM BUILDING,
FROM THE BEGINNING TO THE END OF
THE PROCESS OF DRUG DEVELOPMENT
THERE'S MANY KINDS OF EXPERTISE
THAT ARE NEEDED.
AND IT IS VERY RARE EFFECTIVE
TEAMS ARE PRESENT ONE
INSTITUTION, GOING TO REQUIRE
ACROSS INSTITUTIONAL
COLLABORATION AND CROSS
DISCIPLINARY COLLABORATION TO
CREATE THE TEAMS NECESSARY TO
ADDRESS MANY OF THESE ISSUES.
ONE IMPORTANT CONCEPT THAT CAME
THROUGH IN OUR DISCUSSION ON
WEDNESDAY WAS INDIVIDUAL CANCER
CENTERS JUST DON'T HAVE THE
RESOURCES OR THE BANDWIDTH TO
DEVELOP THESE KINDS OF IDEAS.
FINALLY THE OTHER RESOURCE THAT
IS INADEQUATE AT THE MOMENT IS
COMPOUND LIBRARIES.
ONE ESPECIALLY THAT DESERVES
MORE ATTENTION THAT NED BROUGHT
UP WAS NATIONAL -- NATURAL
RESOURCE LIBRARY THAT EXISTS AT
THE NCI, PROBABLY UTILIZED AND
WHICH IS A RICH RESOURCE THAT NO
ONE KNOWS HOW TO GO AFTER.
SO THOSE ARE MAIN THINGS
COMMITTEE TOOK AWAY, I WANT TO
GIVE SPECIAL THANKS TO ROSE AND
TO VERMA WHO PUT TOGETHER THE
REPORT OF THE SUBCOMMITTEE AND
DID HEAVY LIFTING AND I'M GOING
TO STOP FOR A MINUTE AND -- HAS
THOUGHTS ABOUT THIS AND I WOULD
LIKE TO ALLOW HIM TO HAVE A FEW
MINUTES TO GIVE HIS TAKE ON THE
WORK THAT WE HAVE DONE.
NED.
>> THANK YOU, TIM.
I THOUGHT THAT WAS A TERRIFIC
SUMMARY OF BOTH EFFORTS.
THE -- I -- LIKE TIM I WAS
SURPRISED THAT CELLULAR
IMMUNOTHERAPY TURNED OUT MORE
STRAIGHT FORWARD.
WE THOUGHT OF THESE TOPICS TWO
THINGS WHERE I THOUGHT NCI USE
ADVICE AND THE ACTUAL OLDER
ISSUES AROUND MEDICINAL
CHEMISTRY SEEM IN SOME WAYS MORE
CHALLENGING FOR THE NCI WHERE TO
GO NEXT SO I APPRECIATE BOTH
REPORTS ARE IMPORTANT TO NCI AND
WE FEEL USEFUL AND CERTAINLY
GIVEN US A LOT TO THINK ABOUT.
WHAT I PROPOSE AT THIS TIME IS
THE SECOND REPORT TAKE BACK READ
CAREFULLY THINK THROUGH WHAT WE
CAN AND SHOULD DO HERE, I WOULD
PROPOSE WE REPORT BACK TO THE
JOINT BOARD NEURODATE HOW TO
RESPOND PARTICULARLY THE SECOND
ONE.
AND I THINK THAT -- TAKE IT FROM
THERE.
IN THAT INTERIM I THINK BEST WE
SHOULD LET THE SUBCOMMITTEE BE
DORMANT WHILE WE THINK ABOUT THE
NEXT ISSUES WHETHER WE NEED TO
TAKE ON NATURAL PRODUCTS OR
WHATEVER ELSE IS COMING ON LINE.
WE HAVE A LOT TO WORK THROUGH
NOW.
AS YOU CAN TELL THIS WAS WORK
AND SO I ALSO WANT TO CREDIT
THOSE INDIVIDUALS WHO PUT SO
MUCH TIME INTO IT.
NCI STAFF, EXTRAMURAL PEOPLE AND
PARTICULARLY TIM LEADER SHIP WAS
TERRIFIC IN THIS EFFORTS AND
EXEMPLARY AS SERVICE TO NCI AND
WE ARE SORRY HE IS LEAVING
BECAUSE HE'S SO GOOD AT THIS.
THANK YOU FOR STEWARDING A
THOUGHTFUL PROCESS AND GIVING US
SUCH GOOD ADVICE.
>> THE SUMMARY AVAILABLE FOR
EVERYBODY TO LOOK AT, SENT OUT
BY RICARDO THIS MORNING.
>>
>> THANKS, TIM.
ANY OTHER COMMENTS REGARDING THE
REPORT ON EXPERIENCAL
THERAPEUTICS?
>> I THINK MY COMMENTS CAN BE
DONE BY EMAIL, I THINK THERE WAS
SO MANY IMPORTANT ISSUES THAT
TIM JUST RAISED.
I WOULD RATHER DEFER FEW MINUTES
WE HAVE TO OTHERS WHO WANT TO
TALK ABOUT THEM.
>> JOHN THE ONLY THING TO ADD,
THIS IS SHELLEY IS THAT --
ACADEMIC MED CENTERS AN
UNIVERSITIES SHY FROM THIS
UNNECESSARILY.
IT IS JUST URBAN LE YEAR-END
UNIVERSITIES CAN'T DO THIS,
PURVIEW OF PHARMA.
I DON'T THINK THAT IS THE CASE.
TIM MAY BE RIGHT, IT NEEDS TO BE
MORE INTERINSTITUTIONAL BUT
CLEARLY WE HAVE A LOT OF SMART
PEOPLE IN OUR CHEMISTRY
DEPARTMENT AND PHARMACOLOGY
SCHOOLS, ACADEMIC INSTITUTION
SHOULD NOT SHY FROM THIS.
>> THERE IS A PLAUSIBILITY
BARRIER TO THIS.
THAT HAS BEEN IN PLACE FOR A
WHILE AND I THINK THAT
CONTRIBUTED TO ONE UNFORTUNATE
THING, THE LACK OF TRAINING OF
YOUNG SIGN IT ISES IN THIS
DISCIPLINE ESPECIALLY YOUNG
PHYSICIAN SCIENTISTS WHO REALLY
SEEM TO HAVE NO INTEREST IN THIS
KIND OF DRUG DEVELOPMENTAL
PROBLEM AT ALL.
IT IS JUST BEEN GIVEN TO PHARMA
AND SHOULDN'T BE -- I AGREE
COMPLETELY, IT IS TIME FOR THE
NCI TO TRY TO GET ITS ACT
TOGETHER AND FIGURE OUT WHAT
EXACTLY WILL BE THE BEST THING
TO SUPPORT.
I AGREE WITH NED THERE'S SO MANY
THINGS UNCOVERED BY THIS
PROCESS, IT WILL TAKE A WHILE
FOR THE NCI LEADERSHIP TO DIGEST
JUST WHAT WE LOOK AT ALREADY AND
COME UP WITH THINGS THAT ARE
RATIONAL TO SUPPORT.
>> THEY COULD BE COMPONENTS THAT
ARE REALLY ACADEMIC CENTERED BUT
THEN THE QUESTION BECOMES DARE
USE THE PHRASE PUBLIC PRIVATE
PARTNERSHIP.
TYPES OF MECHANISM THAT HELP
BUILD THESE MULTI-INSTITUTIONAL
PLATFORMS TO SUPPORT THIS TYPE
OF WORK.
ANY OTHER COMMENTS OR DISCUSSION
POINTS?
>> NCI - -- (OVERLAPPING SPEAKERS)
>> I WAS A BIT CURIOUS.
NCI TENDS TO BE TRAILBLAZER IN
MANY OF THESE INITIATIVES BUT
INSTITUTES NIH THAT ARE DOING IN
DRUG DEVELOPMENT THAT COULD
PROVIDE THAT ROADMAP OR SOME
SORT OF WAY HOW THIS CAN BE
DONE, ACADEMIC INSTITUTIONS
PARTNER WITH DRUG DEVELOPMENT
NOT IN THAT AREA OBVIOUSLY BUT
CURIOUS ABOUT ANY OR OTHER
INSTITUTES NIH THAT MAY BE DOING
THIS WORK.
IN A MORE AGGRESSIVE WAY.
>> NCATS COMES TO MIND.
>> SO WE WORK CLOSELY WITH NCATS
ON HIGH THROUGH PUT SCREENING
AND ROBOT UK APPROACHES TO HIGH
THROUGH PUT SCREENING.
NCATS IS A MAJOR USER OF NATURAL
PRODUCTS LIBRARY SO THEY HAVE
REAL INTEREST IN THIS SPACE.
NIAID IS INTERESTED IN THIS
TOPIC AND THERE'S BEEN A LIVELY
SET OF DISCUSSIONS SOME AT NCI
LED BY DANA SINGER INDIVIDUALS
AT NIAID ABOUT NOVEL DATA
APPROACHES TO DRUG DISCOVERY
MACHINE LEARNING DRUG DISCOVERY
AND NOVEL APPROACHES TO
STRUCTURAL BIOLOGY.
THAT MULTIPLE IC INTEREST BOTH
BLESSING AND CURSE BECAUSE I
THINK THE LENGTH OF TIME TAKES
TO DO ANYTHING GOES UP WITH
SQUARE NUMBER OF ICs INVOLVED,
SO BUT I THINK IT IS ALSO IF
THERE IS ENOUGH TRANS-NIH
INTEREST AMAZING THINGS HAPPEN
LIKE COMMON FUND INITIATIVES SO
I THINK WE ARE LOOKING IN BOTH
APPROACHES WHAT SHOULD WE DO ON
OUR OWN AND WHAT NEEDS TO BE
TRANS-NIH.
>> PAULETTE, NEED YOUR HELP
HERE, ARE WE VOTING TO TABLE?
>>
>> WE NEED TO CALL A MOTION TO
ACCEPT.
THEN A SECOND THEN A VOTE.
>> OKAY.
LET'S CALL FOR A MOTION TO
ACCEPT.
>> SO MOVED.
>> SECOND.
>> PROPERLY MOVED AND SECONDED.
DISCUSSION.
NEES.
ABSTENTIONS.
>> OR DO THE NAYS FIRST.
NO NAYS.
ANY ABSTENTION?
>> SO THE REPORT IS UNANIMOUSLY
ACCEPTED.
>> THE REPORT HAS BEEN
UNANIMOUSLY ACCEPTED.
>> NOW WE ARE MOVING ON TO -- --
YOU HAVE A BULLET TO READ.
>> ONE BULLET THE ANNUAL
REVIEWER CONCEPT REPORT IS
POSTED ON THE BSA MEMBERS ONLY
WEBSITE.
I DON'T KNOW IF I SHOULD BE
SAYING THIS OR KEITH BUT -- AND
AS REQUESTED PRIOR YEARS OF THE
REPORT HAVE ALSO BEEN ARCHIVED
TO BE ACCESSED AS WELL.
>> NEXT GOAL.
>> NEXT BULLET IS ARE THERE
OTHER ISSUES THAT YOU THINK THE
BOARD SHOULD BE ADDRESSING?
>> AT THIS POINT WE HAVE A BOARD
MEMBER WHO WOULD LIKE TO MAKE
COMMENTS.
SYLVIA.
>> I APPRECIATE THIS
OPPORTUNITY.
SO WE JUST FINISHED A DISCUSSION
ABOUT THE RENEWAL OF ITCR AND
OUR SUBCOMMITTEE AS YOU KNOW IS
UNANIMOUSLY SUPPORTIVE AND VERY
EXCITED ABOUT THE PROGRESS OF
ITCR.
AS WE DID ON OUR DISCUSSION NOW,
WE FOCUSED ON NEED FOR ITCR TO
CONNECT WITH OTHER NCI PROGRAMS.
AND THROUGH JULIE'S PRESENTATION
WE WERE SO SATISFIED KNOWING
THAT ITCR IS GOING TO -- HAS
CONCERTED EFFORT FOR MORE
FREQUENT SUSTAINED COMMUNICATION
WITH OTHER NCI PROGRAMS AROUND
DATA MANAGEMENT ANALYTICS.
HOWEVER, ALONG THIS THEME, THIS
BROAD THEME OF NCI PROGRAM
INTEGRATION AROUND DATA AND
ANALYTICS, WE RECOMMEND THE NCI
CREATE A MORE SIGNIFICANT
MANDATE IN INFORMATICS DATA
SCIENCE PARTICULARLY IN CCSG,
SPORE, CLINICAL TRIAL NETWORK U
54, AKIN TO THE INFORMATICS
MANDATE IN CTSA.
WE WOULD LIKE TO ADVISE THE NCI
CREATE A COMMITTEE TO PROVIDE
SUCH GUIDANCE WITH I THE,CR NCI
CREATED FANTASTIC PROGRAM THAT
CAN BE USED TO ELEVATE
INFORMATICS AND DATA SCIENCE
RESOURCE COMMITMENTS IN CRITICAL
NCI PROGRAMS.
THESE PROGRAMS NEED MORE
GUIDANCE TO MOVE FORWARD IN
NEEDED WAYS, SO WE RECOMMEND THE
NCI CREATE A COMMITTEE TO
CONSIDER MORE CLEAR INFORMATICS
MANDATES IN LARGE NCI PROGRAMS
SUCH AS SPORES CCG, CLINICAL
TRIALS NETWORKS, U 54, THROUGH
GREATER INTEGRATION WITH THE
ITCR.
>> COMMENTS?
>> LET ME SEE IF DINA HAS
ANYTHING TO SAY.
>> SYLVIA, THANK YOU FOR THOSE
COMMENTS, CLEARLY WE HAVE
INVESTED A HUGE AMOUNT IN IF
ITCR AND THERE ARE MANY VALUABLE
PROGRAMS THAN AS JULIE SHOWED
REALLY HAVE ALREADY BEEN TAKEN
UP BY THIS COMMUNITY.
I THINK THE SUGGESTION AND I
THINK MICHAEL'S ALSO IS ONE HA
WE SHOULD REALLY LOOK AT TO SEE
HOW WE CAN REALLY PROMOTE A MORE
EFFECTIVE UPTAKE OF TOOLS AND
STANDARDIZATION ACROSS ALL THE
CENTERS THOUGH I SAY THAT WITH
SOME HESITATION.
BUT I THINK IT IS CERTAINLY
SOMETHING WE SHOULD LOOK AT AND
PURSUE.
THANK YOU.
>> I AGREE WITH DINA.
LET US THINK IT OVER.
I HAVE TO CONFESS I DON'T KNOW
ENOUGH ABOUT THE CTSA MANDATE TO
HAVE A OPINION.
I NEED TO BE EDUCATED ON THIS
TOPIC.
TO BE CLEAR YOU WOULD RECOMMEND
A SORT OF -- GIVE ADVICE TO THE
NCI WHICH IS ACTUALLY PROBABLY
WORKING GROUP TO PRESUMABLY BSA
I WOULD THINK.
ON BIOINFORMATICS STRATEGY
ACROSS MAJOR PROGRAMS LIKE CCSG
AND SPORES PROGRAM THAT MIGHT
LEVERAGE ITCR, MIGHT NOT
NECESSARILY BE ITCR.
>> THAT'S RIGHT.
WE THOUGHT IT WAS BIGGER SO WE
DIDN'T WANT TO BRING IT UP IN
DISCUSSION.
AND SO PAULETTE RECOMMENDED THAT
WE BRING IT UP HERE.
>> IS THE ISSUE TRAINING OR
SUSTAINING TOOLS, OR DATA
SHARING AND POLICIES ACROSS NCI
INFRASTRUCTURE OR ALL THAT?
>> IT IS ALL OF THAT BUT IT IS
INTEGRATION, IT IS REALLY MORE
STREAMLINING BECAUSE THERE'S ALL
THESE SEPARATE EFFORTS THAT ARE
GOING TO THWART ANY ABILITY TO
REALLY LEVERAGE TYPE OF DATA THE
NCI IS CREATING IN THESE
MULTIPLE PROGRAMS.
SO IT IS REALLY A GREAT TIME TO
BRING ALL THESE FOLKS TO THE
TABLE AND HAVE THESE DISCUSSIONS
BECAUSE THERE'S BEEN A LOT OF
PROGRESS IN A NUMBER OF
INITIATIVES.
AND SO YEAH, IT IS REALLY ABOUT
STREAMLINING, INTEGRATING, FOR
EXAMPLE EVEN WITH ONE PROGRAM
THAT I HAVE BEEN WORKING WITH
CLOSELY WHICH IS A CANCER
SYSTEMS BIOLOGY CONSORTIUM, BOTH
FOLKS IN THOSE PROGRAMS DEVELOP
COMPUTATIONAL MODELS AND THERE
ISN'T AN INTEGRATION WITH ITCR
PLATFORMS.
SO JUST ONE EXAMPLE.
BUT IN THE CONTEXT OF TALKING
ABOUT THAT, WE RECOGNIZE IN MANY
-- EVEN WITH OUR CANCER CENTERS,
THE MANDATE AROUND INFORMATICS
IS BIGGER THAN IT IS AROUND
RIGHT NOW, IT IS NOT JUST
BIOSTATISTICS, IT IS A LARGER
MANDATE AND IT KIND OF GETS
CAUGHT UP IN DISCUSSION OF
BIOSTATISTICS WHICH IS FINE BUT
IT IS DIFFERENT.
I THINK NEEDS TO BE MORE CLEARLY
SPECIFIED, I THINK THE CCSGs
NEED TO UNDERSTAND THAT BETTER
AS WELL.
AND I THINK THE ITCR CAN HELP IN
THOSE REALLY CLEAR FIND THOSE
ISSUES.
>> MICHAEL.
>> SO THINK OF IT NED AS YOU GOT
A LOT OF RICH DATA SOURCES.
WE SAW AT LEAST A HALF DOZEN
SPECTACULAR DATA SOURCES THAT
YOU PRESENTED TODAY IN THESE NEW
COLLABORATIVE PROGRAMS.
THEY ARE ISLANDS UNTO THEMSELVES
WITHOUT THE PIPE AND ANALYTICS
THAT GLUE BIGGER DATA SOURCES
TOGETHER.
DATA COMMONS IS A GREAT RESOURCE
BUT POST ECGA, THE IMPACT USE OF
LARGE DATA SETS ACROSS NCI IS
NOT NEARLY ASPECT TACK LAR AS IT
COULD BE IN MY OPINION.
THE WAY TO DO THAT, IS TO CREATE
THE PIPE AND THE ANALYTIC FRAMES
THESE MODELS PROVIDE AND START
TO PULL THEM TOGETHER.
THIS IS WHERE -- IT IS ALWAYS
HARD FROM LEADERSHIP PERSPECTIVE
TO SAY YOU SHALL DO THIS OR YOU
SHALL CONSIDER THAT.
BUT ITCR IS MASSIVELY
UNDERMARKETTED TO YOUTH PROGRAMS
AS STARTING POINT THERE'S GREAT
SOFTWARE AND TOOLS THAT ARE
THERE THESE PROGRAMS COULD BE
POINTED TO, AS FIRST ORDER
CONSIDERATIONS INSTEAD OF
SETTING UP NEW HOME BREW FOR
EACH COORDINATING CENTERS AND
EACH ANALYTIC FRAMES ACROSS
PROGRAMS.
THIS IS JUST A REALLY MISSED
OPPORTUNITY.
I TALKED TO YOU ABOUT THIS AND
YOU HEARD THIS WITH MANY OF MY
COMMENTS ON THESE PROGRAMS USING
THE PIPE, USING SOLID PIPE THAT
IS WELL SUPPORTED ACROSS
MULTIPLE PROGRAMS GETS THINGS
DONE, LET ME EXPLAIN THE CTSA
PIECE BECAUSE I RUN THE
BIOMEDICAL INFORMATICS SCORE FOR
CTSA.
YOU CAN THINK OF RCSG PROGRAM
MAJORITY SUPPORTS SPORES, THEY
MADE INFORMATICS MANDATE, WHEN
COVID HIT YOU WERE ABLE TO SHARE
180 MILLION PATIENT DATA THROUGH
COMMON SET OF THREE DATA MARKS
NCI -- NCATS SUPPORTED TO THEN
BLEW WHAT I THIS I IS MAJOR
DISCOVERY PROGRAM FOR THAT
DISEASE.
NCI WOULD BE WELL SERVED TO
INTEGRATE ITS OWN IN THE SAME
FASHION FROM BIOSPECIMENS TO
GENOMIC DATA TO IMAGING, USING
STANDARD SOFTWARE MODELS AND PUT
THAT IN PLACE FOR CCSGS AND
SPORES.
>> MIKE.
THAT IS A GREAT IDEA TO TRY TO
SEE WHAT CAN LEVERAGE FROM CTSA.
I HAVE TWO QUICK THOUGHTS TO
OFFER FOR CONCENTRATION OF THE
-- YOUR BOARD N CAT AS YOU
DELIBERATE, ONE, HOW DO WE SCALE
OR GET MORE ENGAGEMENT WITHIN
COMMUNITY ENGAGEMENT IN NCI
PROGRAM PROGRAMS BEYOND CCSG,
SILOED BOB TALKED THIS QUITE A
BIT, WORTH CONSIDERING NIH WIDE
PROGRAM FOR COVID AND IT IS
IMPORTANT FOR NCI TO THINK ABOUT
HOW THIS IS DONE, UNDER CCSG.
THIS IS A QUESTION WE TALKED
ABOUT THE RFA AND WHAT IS THE
COST OF THE RPGs.
THERE IS A GOOD DISCUSSION
AROUND THE -- UNDERSTAND MORE
WHAT IS THE OFFSET OF COSTS,
OPPORTUNITY COSTS FOR RPG WHEN
THE RFA PROPOSED AND APPROVED.
SO THAT IS A QUICK I WANTED TO
SHARE.
>> I THINK ANNA BARKER.
>> COUPLE OF THOUGHTS ON THIS
DATA, DATA WAS THE RIGHT POINT.
WE SET UP TCGA THAT WAS THE
FIRST TIME WE REALLY ACTUALLY
HAD TO COLLABORATE ACROSS THAT
MANY INSTITUTIONS.
BELIEVE ME THAT WAS PULLING OUT
NAILS, NOT A SIMPLE THING TO DO.
WE DON'T -- I REMEMBER WHEN
PRESIDENT BIDEN WORKING WITH HIM
AND HIS FOUNDATION SETTING UP
THE FIRST MOON SHOT, HE WAS
TOTALLY STUNNED THAT WE COULDN'T
-- DATA, THAT WAS A MANTRA OF
EVERYTHING HE TALKED ABOUT AND
TODAY THAT'S STILL A MAN A TRAY
OF EVERYTHING TALKED ABOUT.
THE FACT IS WE HAVE THIS HUGE
ENTERPRISE IN CANCER WE HAVE
GROWN IT OVER THESE 50 YEARS AND
EVERYBODY HAS THEIR OWN WAY OF
DOING THINGS, THEY HAVE THEIR
OWN DATA MODEL, THEIR OWN DATA
SHARING, TOOLS, THEY HAVE
STANDARDS OR NO STANDARDS, GREAT
THING THAT CAME OUT OF THAT
PRESIDENT BIDEN INITIATIVE NOT
THAT WE DON'T HAVE STANDARDS WE
CAN HAVE BASKET FULL OF
STANDARDS, EVERYBODY HAS
STANDARDS, FOR NCI INSPIRATION
OF EVERYTHING, WHAT WE ARE TO
PROPOSING HERE, COME BACK TO THE
ORIGINAL PROPOSAL, IT IS THE
BEST IDEA EVER.
HOW DO WE DO IT AND HOW MUCH CAN
WE DO AND THE LAST THING I WILL
SAY IS DATA JUST PUTTING DATA IN
THE DATA MINING ACTIVITY OR DATA
SET IF WE PAY THROUGH NCI SHOULD
BE YES YOU HAVE TO DO THAT.
PRESIDENT BIDEN WAS SURPRISED TO
LEARN THAT WE HAVE NO -- HUNDRED
-- WHO DOESN'T WANT TO SHARE THE
DATA.
WE HAVE LOTS OF INSTANCES OF
PAYING PEOPLE, I KNOW IN TCGA WE
HAD LITERALLY PULL THE DATA OUT
AND MANY TIMES WE CAN'T GET IT.
WE HAVE NO -- THERE IS NO
RECOURSE.
SO -- (OVERLAPPING SPEAKERS).
>> HOWARD THEN FRANCIS.
>> IN CONTRAST TO MY COLLEAGUES
WHO TALKED ABOUT BASICALLY
EXPANDING EXISTING RESOURCES OR
YOU SHIPMENT MANDATES OR
PENALTIES I'M INSPIRED BY MY
RECENT READING OF OF BOOK I
SUGGEST FOR PEOPLE ESPECIALLY
PAGE 60, ANALYZING INNOVATIVE
WORKING PRACTICES THAT SUCCEEDED
BY PRIVATE PUBLIC ORGANIZATIONS,
TO DRIVE CHANGE AND QUALITY OF
DIVERSE BEHAVIORS WITH MINIMAL
OR NO EXPANDED RESOURCES,
SOMETIMES LESS RESOURCES THAN
THOSE EMPLOYED FOR YOU SHALL
MANDATES, SO THE BOTTOM LINE IS
IN CONTRAST TO THE CURRENT
LANGUAGE, ATTRIBUTED TO ME, IN
THE EXPERIMENTAL THERAPEUTIC
MINUTES, IT IS NOT A BIG DEAL
BUT I DIDN'T SAY EVER TO EXPAND
EXISTING RESOURCES AND MY
THOUGHTS ABOUT THIS UPCOMING
PROPOSAL THAT NED HAD AND OTHERS
ABOUT HAVING NCI EVALUATE DATA
SHARING PRACTICES BOTH
PRE-CLINICAL AND CLINICALS, I
WOULD RATHER HAVE NCI EVALUATE
PLAN AND UPCOMING DISCUSSION
ABOUT MULTI-REGIONAL WORK
STREAMS AND METRICS.
WE ARE NOT THE ONLY ONES I'M
FAMILIAR WHAT IS GOING ON IN THE
EUROPE AND THE UK, ESPECIALLY
ALONG WITH OPTIONS TO SUPPORT
TRAINING RESEARCH AND COST
EFFECTIVE BEST PRACTICES, ABOUT
SUSTAIN QUALITY AND VALUE OF
SHARED DATA DATABASES AND
ANALYTICS.
I EMPHASIZE COST EFFECTIVE.
BECAUSE I BELIEVE THERE ARE
INNOVATIVE APPROACHES THAT DON'T
REQUIRE WHAT WAS JUST STATED
ABOUT THE PENALTIES AND PANEL
DATES AND EXPANDING COST
RESOURCES.
>> GREAT.
FRANCIS, I THINK THIS WILL STOP
HERE AND MAYBE START OHIO WE
WANT TO VOTE ON THE
RECOMMENDATION.
>> WE DON'T VOTE ON THE
RECOMMENDATIONS.
JUST THAT RECOMMENDATIONS.
NCI WILL GIVE RECOMMENDATIONS
AND SUGGESTIONS, SOME VOTES.
IF IT DECIDES TO MOVE FORWARD
THE INSTITUTE WILL COME BACK
WITH SOMETHING YOU CAN VOTE ON.
>> OKAY?
>> FRANCIS.
>> I'LL BE QUICK.
FOLLOW-UP ON THE COMMENTS.
THIS COMES FROM MY EXPERIENCE
THROUGH CTSA OF MY INSTITUTION
AND AS PI OF OUR SPORE, THIS IS
CHALLENGING BECAUSE THERE ARE
MAJOR ISSUES, HIPAA ISSUES WITH
PATIENT DATA AND MOST DATA HAVE
BEEN MOST OF THESE SPORES ARE
LEVERAGED AND BUILD UPON THE
INSTITUTIONAL INFRASTRUCTURE AND
REGULATIONS THAT EXIST.
SO I THINK THE RECOMMENDATION BY
NED AND DINA TO SET UP A GROUP
LOOKING TO THIS IS CRITICAL.
BECAUSE MANDATE VERY DIFFICULT
GIVEN UNIQUENESS OF THIS MAYBE
GERMINATE DOWN TO SET OF SOME
PARAMETERS THAT WOULD MAKE
SENSE.
MIGHT BE THE WAY TO GO.
SO WE DO A LOT OF DATA HANDLING
AND MANAGING BUT BUILT ON
INFRASTRUCTURE OF THE
INSTITUTION AND THE SUPPORT THAT
INSTITUTION GIVES TO DO THIS.
WE CAN BE EXTREMELY EXPENSIVE
AND QUITE COMPLEX.
SO I THINK THAT WORKING GROUP IS
A GOOD IDEA TO JUST TEASE IT OUT
TO SEE HOW WE DEAL WITH IT.
>> SO THE WORKING GROUP YOU ARE
TALKING ABOUT FOR INSTANCE I
THINK YOU ARE ALLUDING TO WHAT
SYLVIA WAS PLACED ON THE TABLE.
>> I THINK SO.
NED REFERRED TO --
>> LIKE TO BE CLEAR, I DON'T
THINK I'M PROPOSING THAT YET.
I THINK WE HAVE PHOTO THINK
ABOUT IT.
THE IMPORTANT PART IS WHAT WOULD
THE CHARGE BE.
IF IT'S MERELY HOW WE DO DATA
SHARING BETTER, I DON'T THINK WE
NEED THAT WORKING GROUP, WE HAVE
TALKED ABOUT THAT ISSUE AND
CHALLENGES THAT ARE WELL KNOWN.
BUT WHAT FEELS NEW IS THIS SORT
OF BIOINFORMATICS HOMOJOE NAYTY
WE HAVE NOT TALKED MUCH --
HOMOGENEITY WE HAVE NOT TALKED
ABOUT AND IMPORTANT TOPIC SO WE
NEED TO THINK ABOUT WHO -- WHAT
ADVICE CAN WE GET AND I'M VERY
WORRIED AT FRANCIS AS YOU
ALLUDED TO CREATING AN UNFUNDED
MONEY DATE FOR SPORE PROGRAM
THOSE PROGRAMS ARE BOTH SOMEWHAT
TAXED BUT I THINK THAT THAT
MIGHT NOT BE WHAT IS ASKED FOR
HERE.
SO WE -- AS PAULETTE SAID I
THINK WE SHOULD TAKE THIS
RECOMMENDATION BACK AND WE WILL
GIVE AN ANSWER, LET US RESEARCH
AND MAYBE EVEN ASK MORE
QUESTIONS ABOUT THIS AND GET
BACK TO YOU AT A FUTURE MEETING
IF --
>> GREAT APPROACH.
>> THANK YOU, EVERYONE FOR THAT.
THAT WAS A GREAT DISCUSSION.
ANY OTHER THOUGHTS ISSUES
CONCERNS RECOMMENDATIONS?
THAT YOU THINK EITHER OF THE
BOARD OR BOTH THE BOARDS OR NCI
SHOULD CONSIDER?
>> ONE POINT I FAILED TO SAY WE
COMMITTED TO A PRESENTATION ON
THE CANCER RESEARCH DATA COMMONS
AND THAT'S IMPORTANT TOO IN THIS
DISCUSSION I THINK.
>> YES IT INTEGRATES HA
DISCUSSION.
ESPECIALLY THINKING IT'S
ASSOCIATED WITH SUGGESTIONS FOR
FUTURE AGENDA ITEMS.
I HEARD EARLIER SOMEONE TALK
OBESITY BUT ARE THERE OTHER KEY
AREAS ANYONE WOULD LIKE TO
NOMINATE --
>> PRESENTATION ON -- TRAINING
OPPORTUNITIES.
>> EDUCATIONAL TRAINING
ACTIVITIES?
>> SOME POINT WE TALKED ABOUT
DR. GOKDARD COMING TO GET HER
VISION.
SO WHENEVER THAT IS APPROPRIATE
SHE SETTLES IN I WOULD LOVE TO
HAVE THAT AS WELL.
>> YOU CAN SEE PHIL TOOK ABOUT A
YEAR, I ENCOURAGE THAT THESE
DIVISIONS ARE LARGE AND
PORTFOLIOS ARE COMPLEX ALLOW DR.
GODDARD TO TELL US WHEN SHE
FEELS COMFORTABLE BUT MIGHT TAKE
A WHILE GIVEN COMPLEXITY OF --
>> ONE THING LOOKING AT -- WITH
THIS INITIATIVE TODAY ACTUALLY
GOING OUT OF COUNTRY TO SET UP
CAPABILITIES, CAPACITY BUILDING.
MAYBE HAVE SOMEBODY FROM THE
FOGARTY INTENTER, IF YOU ARE
AWARE IT IS QUITE RESOURCE IN
TERMS OF NCI INTERNATIONAL
ACTIVITIES.
MAYBE HAVING A PRESENTATION
SOMETIMES FOR -- FROM THE
FOGARTY CENTER WOULD BE VERY
HELPFUL.
>> ASHI PUT A COMMENT IN THE
CHAT ABOUT AGING CANCER.
I KNOW THERE WERE SOME --
>> ALLOWED TO COMMENT YET SINCE
I WASN'T BEEN OFFICIALLY
APPROVED.
>> I WILL JUST SAY IT, THERE
HAVE BEEN SOME INTERACTIONS
BETWEEN NCI AND AGING AND SO I
THINK IT WOULD BE INTERESTED TO
HEAR ABOUT WHAT IS GOING ON
THERE, WHAT IS GOING ON
CURRENTLY AND IF THERE ARE
ANYTHING FOR FUTURE INTERACTION
BETWEEN THE TWO ICs.
>> YOU CAN PROVIDE COMMENT, JUST
CAN'T VOTE.
>> I HAVE WRITTEN THESE DOWN, I
THINK THESE -- FEW OTHERS AS
WELL -- GREAT RECOMMENDATIONS, A
FEW OTHERS AS WELL TOO.
>> OKAY.
IF YOU HAVE ANY ADDITIONAL
THOUGHTS THEN BRING IT UP LATER,
JUST SEND THEM TO ME, KEITH AND
PAULETTE.
WE WILL COLLATE THOSE AND ENSURE
THEY MAKE THEIR WAY ON TO FUTURE
AGENDAS.
INDIVIDUAL BOARD AGENDA
SUGGESTIONS SHOULD BE SENT TO
REPRESENTATIVE BOARD CHAIR AND
PAULETTE.
IF NCAB MEMBER SEND TO ME AND
PAULETTE, IF BSA MAKE SURE YOU
ADD KEITH AND PAULETTE.
ANY OTHER BUSINESS?
IF NOT WE CAN MOVE TO ADJOURN
THIS MEETING.
THANKS EVERYONE I THOUGHT IT WAS
A FANTASTIC MEETING, MY FIRST
EXPERIENCE AND THANK YOU
PAULETTE.
>> GREAT JOB CHAIRS AND GREAT
JOB COMMUNITY MEMBERS.
>> EVERYONE HAVE A GREAT HOLIDAY
SEASON.
NCAB MEMBERS WE WILL SEE YOU IN
FEBRUARY.
>> SAD HOW GOOD WE ARE GETTING
IN ZOOM MEETINGS.
WE WANT TO RETURN TO FACE TO
FACE AS SOON AS POSSIBLE.
>> ABSOLUTELY.
>> ALL RIGHT.
>> BYE-BYE.