>>WE'D LIKE TO WELCOME THE
MEMBERS OF THE BSA AND NATIONAL
CANCER ADVISORY BOARD, NCAB, EX
OFFICIO MEMBERS, PANEL MEMBERS,
STAFF AND GUESTS.
TODAY WE'RE GOING TO START WITH
A PRESENTATION FROM IRENE
GHOBRIAL, PROFESSOR OF MEDICINE
AT HARVARD, LEVINE FAMILY CHAIR,
PREVENTIVE CANCER THERAPY,
DANA-FARBER CANCER INSTITUTE.
DO WE HAVE IRENE?
>>I'M CHECKING TO SEE.
>>SHE DOESN'T APPEAR TO BE ON,
WE'LL CHECK.
>>HMM.
AN AREA NEAR AND DEAR TO MY
HEART, I CAN GIVE A
PRESENTATION.
[LAUGHTER]
AND SO CAN KAREN.
[LAUGHTER]
>>THIS IS A FIRST.
BUT WE ARE PATIENT.
>>I'M ASSUMING SHE WAS SENT
REMINDERS.
>>SHE'S SCHEDULED TO BEGIN AT
1:05.
WE STILL HAVE THREE MINUTES.
>>I'M ALWAYS LOOKING FOR YOUR
CUE, PAULETTE.
>>I THINK SHE JUST JOINED.
SHE IS ON.
YES, I JUST SAW HER.
>>GREAT.
IRENE, DO WE HAVE YOU?
>>YES, I'M HERE.
>>AWESOME.
WE CAN SHARE YOUR SLIDES.
I'VE ALREADY INTRODUCED YOU, AND
THE TITLE OF YOUR PRESENTATION.
SO WHENEVER YOU'RE READY TO
START.
>>ALL RIGHT.
NEXT SLIDE.
SO JUST TO REMIND EVERYONE
MULTIPLE MYELOMA IS A BLOOD
MALIGNANCY IN 35,000 NEW CASES
PER YEAR IN THE UNITED STATES.
EVERY PATIENT WHO IS DIAGNOSED
RIGHT NOW WITH MULTIPLE MYELOMA
MUST HAVE HAD THE PRECURSOR
CONDITION, MGUS OR SMOLDER
MULTIPLE MYELOMA WITH A HIGH
CHANCE OF DEVELOPING MYELOMA,
10% PER YEAR, AND IN SOME
PATIENTS WE CONSIDER THEM HIGH
RISK SMOLDERS, 50% CHANCE OF
PROGRESSION WITHIN TWO YEARS.
IT'S THE END ORGAN DAMAGE,
PATIENTS HAVE THE MALIGNANT
CANCER CELLS IN THEIR BONE
MARROW BUT ALSO HAVE THE
CRITERIA, HYPER CALCEMIA, AND IF
WE THINK ABOUT INCIDENCE OF MGUS
IN THE POPULATION, IT'S ABOUT 3%
IN THE POPULATION OVER THE AGE
OF 50, AND THAT'S NOT ACCOUNTING
FOR THE HIGH RISK OF THAT
HAPPENING IN AFRICAN AMERICANS
OR IN PEOPLE WITH THE FIRST
DEGREE RELATIVE WITH MYELOMA OR
ANY B CELL MALIGNANCY, TWO TO
THREE TIMES HIGHER CHANCE OF
DEVELOPING MGUS.
NEXT SLIDE.
IF WE START THINKING ABOUT THIS,
WHAT ARE THE NUMBERS FOR
MULTIPLE MYELOMA IN THE
POPULATION, TWO TO THREE TIMES,
EVERY CASE HIGHER IN THE AFRICAN
AMERICAN POPULATION IS BECAUSE
THEY HAVE AN EARLIER PRECURSOR
CONDITION.
IT'S NOT BECAUSE USUALLY THEY
PROGRESS MUCH MORE RAPIDLY FROM
MGUS TO MYELOMA, NOT RAPID BUT A
HIGHER CHANCE AT DEVELOPING AT
EARLIER STAGE EVEN AT AGE 30 AND
ABOVE.
IF YOU LOOK AT CURRENT NUMBERS
WE HAVE ONE OUT OF FIVE
DIAGNOSED, AFRICAN AMERICANS OR
BLACK
BLACK.
BY 2034 WE EXPECTED TO BE 24%.
MYELOMA IS MORE COMMON IN
AFRICAN AMERICANS AT YOUNGER
AGE.
AGAIN, LIKELY THAT'S BECAUSE
THEY GET DIAGNOSED WITH MGUS OR
DEVELOP MGUS AT YOUNGER AGE SO
CHANCES OF IT GOING ON TO
DEVELOP MYELOMA HAPPENS AT
YOUNGER AGE.
THINK ABOUT MEDIAN AGE OF
DEVELOPING MYELOMA IT'S 65 TO
70, YOU A INDICATION AT -- YOU A
INDICATIONS AT OLDER AGE,
AFRICAN AMERICANS AND HISPANICS
AT YOUNGER AGE.
THE PROBLEM THOUGH IS OUR
PATIENTS ARE NOT BEING DIAGNOSED
AT THAT EARLIER STAGE.
IN FACT, BY THE TIME THEY HAVE
SYMPTOMS TO THE TIME THEY ARE
DIAGNOSED WITH MYELOMA, THERE'S
A HUGE DELAY IN THE AFRICAN
AMERICAN POPULATION, COMPARED TO
THE CAUCASIAN POPULATION.
AND THAT DELAY COULD BE FROM
MANY FACTORS, ONE ACCESS TO GOOD
HEALTHCARE AND SYSTEM OF CARE
FOR PATIENTS WHO ARE OF AFRICAN
DESCENT, BUT TWO, COULD BE
BECAUSE THEY HAVE UNDERLYING
RENAL INSUFFICIENCY,
MISDIAGNOSED, UNDIAGNOSED,
DIABETES.
YOU EXPECT BY THE TIME THEY GET
DIAGNOSED THEY SHOULD ACTUALLY
RECEIVE THERAPY EQUALLY AND
EQUITABLY COMPARED TO THE
CAUCASIAN POPULATION.
UNFORTUNATELY, THAT'S NOT TRUE.
SO IF WE LOOK AT THE SURVIVAL OF
OUR PATIENTS WHO ARE AFRICAN
AMERICAN
[AUDIO DISTORTION]
ALL OF THE AMAZING DRUGS RIGHT
NOW FOR MYELOMA, OVER 15 NEW
FDA-APPROVED DRUGS OVER THE LAST
10 YEARS OR SO AND IT'S
IMPRESSIVE THE SURVIVAL WE HAVE
NOW OF PEOPLE LIVING INSTEAD OF
3 TO 5 YEARS, 10 TO 15 YEARS IN
MYELOMA.
WE GOT AN ANTIBODY APPROVED A
FEW WEEKS AGO, AND YET IF YOU
THINK ABOUT IT, ACCESS TO THOSE
GREAT DRUGS THAT WE HAVE IN
MYELOMA IS VERY DISMAL IN OUR
AFRICAN AMERICAN POPULATION.
SOME OF THOSE SLIDES ARE FROM MY
FRIEND WHO CALLS IT THE THREE
Ts, DON'T HAVE ACCESS TO
TRIPLE THERAPY, NOW WE EVEN HAVE
FOUR DRUG COMBINATIONS, DON'T
HAVE ACCESS TO TRANSPLANT, DON'T
HAVE ACCESS TO CAR T THERAPY,
AND THE FOURTH ONE THEY DON'T
HAVE ACCESS TO CLINICAL TRIALS.
THIS WAS REALLY HIGHLIGHTED BY
DR. GORMLEY SHOWING LESS THAN 8%
OF OUR POPULATION WHO ARE
AFRICAN AMERICAN HAVE ACCESS TO
CLINICAL TRIALS OR ARE ENROLLED
IN CLINICAL TRIALS, THAT SHOWS
THERE'S A HUGE DISCREPANCY
BETWEEN WHAT WE HAVE ACCESS TO
AND WHAT OUR PATIENTS WHO ARE OF
AFRICAN AMERICAN DESCENT ARE
INDEED GETTING TO ACHIEVE OR
RECEIVE IN OUR CURRENT CARE.
NEXT SLIDE.
NOW, IF YOU THINK ABOUT HOW TO
IMPROVE ON THAT, YOU ACTUALLY
TREAT THE PATIENTS THE SAME WAY,
AND THIS WAS DONE IN EMORY,
ENROLLED AFRICAN AMERICANS ON
CLINICAL TRIALS WITH EQUITABLE
CARE, INDEED THE SURVIVAL
EXACTLY IS THE SAME.
IF WE IMPROVE OUR CARE TO OUR
PATIENTS, IN FACT THEIR SURVIVAL
WOULD BE BETTER OR THE SAME AS
CAUCASIAN POPULATION.
NEXT SLIDE.
AND THAT COMES BECAUSE THEIR
UNDERLYING BIOLOGY, BIOLOGICAL
CHANGES OF MULTIPLE MYELOMA OF
THE TUMOR CELLS THEMSELVES ARE
LIKELY ACTUALLY BETTER IN A
PATIENT WHO IS AFRICAN AMERICAN
THAN CAUCASIAN POPULATION.
THE NUMBERS ARE SMALL AND WE'RE
NOT SURE INDEED THOSE ARE EXACT,
NEED MORE TRIALS TO UNDERSTAND
UNDERLYING BIOLOGY WHY SOMEONE
OF AFRICAN DESCENT, TUMOR CELLS
MAY BE DIFFERENT THAN CAUCASIAN
POPULATION, WE'RE LOOKING AT
GERMLINE SEQUENCING DATA IN
THOSE PATIENTS BUT WE THINK THAT
INDEED AFRICAN AMERICANS MAY
HAVE A BETTER PROGNOSIS, LESS OF
17P AND 13Q DELETION WE MAY GIVE
WORSE PROGNOSIS IN OUR PATIENTS
WITH MYELOMA.
AND THIS WAS FURTHER CONFIRMED
IN MULTIPLE OTHER STUDIES EVEN
IN EMORY UNIVERSITY WHERE THEY
TREATED EVERYONE WITH RVD, WHERE
WE HAVE NOW THE NOVEL THERAPIES
SO THE EFFECT OF CYTOGENETICS
WOULD BE CRITICAL, THOSE
PATIENTS HAVE BETTER COMPARED TO
CAW CAUTION POPULATION, LESS OF
THE 1Q GAIN, MORE 1:14, LESS 17P
DELETION, LESS 13Q DELETION.
WITH THAT IN MIND, WE TRY ASK
THE QUESTION WHAT CAN WE DO TO
CHANGE ALL OF THIS?
HOW CAN WE IMPROVE ON EARLY
DETECTION OF OUR PATIENTS
ESPECIALLY AFRICAN AMERICAN
COMMUNITY THAT HAS HIGHER
INCIDENCE TO DEVELOP MGUS AT
YOUNGER AGE, EMPOWER THEM TO BE
DIAGNOSED EARLY TO INTERCEPT
BEFORE END ORGAN DAMAGE, KIDNEY
DAMAGE, BROKEN FRACTURES, AND
BRING THE BEST CLINICAL TRIAL
DRUGS AND BEST DRUGS WE HAVE
INCLUDING IMMUNOTHERAPY TO THE
EARLIER SETTING TO PREVENT
FURTHER PROGRESSION OF THE
PATIENT AND POTENTIALLY IMPROVE
SURVIVAL IN GENERAL OF OUR
PATIENTS SO THE SPECTRUM IS
EARLY DETECTION AND EARLY
INTERCEPTION BUT IS MUCH BETTER
AND GIVES US CONFIDENCE ENOUGH
TO APPLY TO THE AFRICAN AMERICAN
COMMUNITY BECAUSE THAT CAN MAKE
A HUGE DIFFERENCE IN THEIR
SURVIVAL.
NEXT SLIDE.
SO HOW DO WE DO THAT?
AGAIN, I USE HERE BREAST CANCER
AS EXAMPLE TO REALLY
DIFFERENTIATE HOW WHAT WE'RE
DOING FOR MYELOMA COMPARED TO
BREAST CANCER.
LOOK AT BREAST CANCER, WE
SCREEN, YET IN MULTIPLE MYELOMA
A BLOOD TEST IS SPECIFIC, SERUM
ELECTROPHORESIS, EASIER THAN
BREAST SCREENING.
WE TELL THEM WAIT UNTIL YOU HAVE
DAMAGE IN YOUR ORGANS, UNTIL YOU
HAVE FRACTURES IN YOUR BONES,
AND THEN I TREAT YOU.
WE HAVE PROBABLY AMAZING DRUGS
IF WE JUST USE THEM EARLIER WE
MAY CHANGE COMPLETELY THE
SURVIVAL OF MYELOMA.
IT'S SIMILAR TO TELLING A WOMAN
WITH BREAST CANCER YOU'RE
ASYMPTOMATIC, WAIT UNTIL YOU
HAVE METASTASIS AND THEN I TREAT
YOU.
AGAIN, THAT CONCEPT NEEDS TO BE
CHANGED, WE NEED TO THINK OF
EARLY SCREENING AND EARLY
INTERVENTION IN PATIENTS WITH
MYELOMA TO CHANGE THEIR
SURVIVAL.
WE STARTED BY STAND UP TO CANCER
DREAM TEAM GRANT, THE PROMIS
STUDY, A NATIONWIDE EFFORT THAT
WE STARTED SCREENING EARLY TO
DETECT MGUS IN THE COMMUNITY,
SPECIFICALLY HIGH RISK
COMMUNITY, PEOPLE WHO ARE OF
AFRICAN AMERICAN DESCENT OR
FIRST DEGREE FAMILY MEMBER WITH
MULTIPLE MYELOMA OR OTHER B CELL
MALIGNANCIES.
THE EFFORT WAS DIRECTED TO
PATIENT NATIONWIDE, LIKE ALL OF
US, UNLIKE MANY OTHER EFFORTS,
PATIENTS ARE THE PARTICIPANTS,
ARE EMPOWERED TO BE PART OF THIS
AND IT'S NOT COMING FROM THE
PHYSICIANS, IT'S ALL OVER THE
WEBSITES SO PATIENTS CAN CLICK
ON IT OR LOOK AT THE URL AND GO
ON AND SIGN UP FOR THEIR OWN
CARE OR THEIR OWN SCREENING.
NEXT SLIDE.
OUR QUESTIONS WERE REALLY WHY
DOES IT HAPPEN AT AN EARLIER
STAGE AND WHY DOES IT HAPPEN IN
A HIGH RISK POPULATION AS IN
AFRICAN AMERICANS OR FIRST
DEGREE FAMILY MEMBERS?
YOU CAN SEE WE'RE DOING WITH
MANY OTHER MEMBERS FROM THE
BROAD INSTITUTE, M.I.T., MEMBERS
FROM THE COMMUNITY IN MYELOMA
ASKING QUESTIONS OF GENETICS AND
GERMLINE SEQUENCING, WHY IT
HAPPENS, IMMUNE CELL SEQUENCING
TRYING TO UNDERSTAND IS IT
IMMUNE CELL DYSREGULATION, TUMOR
TELL SEQUENCING DEFINING WHETHER
INDEED PATIENTS OF AFRICAN
DESCENT HAVE DIFFERENT PROGRESS,
IF WE DON'T INTERVENE THERE'S NO
BENEFIT, WE'RE ONLY CAUSING
WORRY.
IT'S NOT JUST TAKING WHAT
HAPPENS IN MYELOMA BUT ASKING
WHAT ARE ALTERATIONS IN THE
TUMOR AND IMMUNE CELLS AT THE
MGUS AND SMOLDERING STATES.
[AUDIO DISTORTION]
SPECIFIC FOR THEM.
NEXT SLIDE.
AGAIN I SHOWED YOU THE INCLUSION
CRITERIA, SIMPLE, ANYONE OVER
THE AGE OF 30, WE CHANGED FROM
AGE 40 TO 30 WHEN WE FOUND SO
MANY AFRICAN AMERICANS SCREENING
WITH EARLIER DISEASE STAGE AND
WITH EARLIER AGE IN GENERAL SO
WE SCREEN OF AGE 30, PEOPLE WHO
IDENTIFY OF AFRICAN DESCENT,
FIRST DEGREE FAMILY MEMBERS,
THOSE ARE AT HIGH RISK, WE
WANTED TO CAPTURE THE WHOLE
FAMILY, ESPECIALLY WITH GERMLINE
SEQUENCING, ENCOURAGED SECOND
DEGREE AND THIRD DEGREE FAMILY
MEMBERS WITH AGE OVER 18 AND
ABOVE.
NEXT SLIDE.
I LOST MY SLIDES.
PERFECT.
THANK YOU.
THIS IS SHOWING YOU THE EFFORT,
IT'S EASY, THEY SIGN UP ONLINE
ON TABLETS, ON THEIR PHONE,
AGREE TO THE TERMS, LESS THAN
FIVE MINUTES, RECEIVE A BLOOD
KIT.
WE WORKED WITH QUEST, THEY CAN
GO TO ANY QUEST LAB AND SCHEDULE
[AUDIO DISTORTION]
THEY RECEIVE THE RESULTS WHETHER
POSITIVE OR NEGATIVE.
AND IF THEY ARE POSITIVE WE CALL
THEM, WE HAVE A TEAM INCLUDING
MYSELF, CALL THE PATIENTS, TELL
THEM WHAT IT IS AND PROVIDE THEM
CARE.
IF IT'S NEGATIVE, OF COURSE WE
E-MAIL THEM AND FOLLOW THEM AND
RESCREEN IN THREE YEARS.
NEXT SLIDE.
SO THIS IS SHOWING SOME OF THE
EFFORTS, REALLY A NATIONWIDE
EFFORT, IT WAS BOOTS ON THE
GROUND EFFORT.
WE GOT HURT IN COVID BECAUSE WE
WOULDN'T DO THAT BUT WE'VE DONE
HEALTH FAIR EVENTS, IN MANY
STATES, WORKED WITH CONGRESS
REPRESENTATIVES INCLUDING AYANNA
PRESSLEY AND MANY OTHERS.
POST-COVID WE JOINED THE 2022
INDIANA BLACK AND MINORITY
HEALTH FAIR, 177 PARTICIPANTS
OVER 4 CASE ACCRUED ON THE
PROMISE STUDY INCLUDING ONE
PATIENT WHO DID NOT WANT TO BE
ON THE STUDY DECIDED SHE WOULD
GIVE A BLOOD SAMPLE, FOUND TO
HAVE HIGH LEVEL, LIKELY TO GET
RENAL FAILURE, GOT HER TO SEE A
PHYSICIAN IN THE WEEK.
THAT'S ONE CASE, DIAGNOSED EARLY
WITHOUT HAVING END ORGAN DAMAGE.
WE HAVE A LOT OF CASES WITH MGUS
SMOLDERING EARLY STAGE DESCRIBED
LATER.
NEXT SLIDE.
DURING COVID WE HAD MANY EFFORTS
ON ZOOM, INCLUDING ALSO
EDUCATIONAL SESSIONS.
THAT'S CRITICAL BECAUSE YOU HAVE
TO LEARN TO GAIN TRUST, TO LEARN
TO WORK WITH THE COMMUNITY AND
REALLY UNDERSTAND WHAT IS THE
NEED, HOW CAN YOU GAIN TRUST,
HOW CAN YOU REALLY WORK TOGETHER
WITH THE COMMUNITY TO PROVIDE
THE CARE.
NEXT SLIDE.
SO THIS IS JUST PROMISE BY THE
NUMBERS.
WE'RE ONGOING.
WE HAVE 12,592.
THE PROMISE POSITIVE CASES ARE
ABOVE 1,000 CASES.
NEXT SLIDE.
AND WE'RE ACCRUING IN THE UNITED
STATES, JUST OPENED SOUTH
AFRICA, HOPING TO OPEN KENYA,
GHANA, ISRAEL AND MANY OTHERS.
WE'VE RECEIVED MANY SAMPLES FROM
OUR MASS GENERAL AT BRIGHAM NEW
ENGLAND AREA, THE MGB BIOBANK WE
CALL IT.
WE HAVE 3,866 PEOPLE OF AFRICAN
DESCENT SCREENED TO DATE, THE
LARGEST NUMBER THAT HAS BEEN
SCREENED FOR MYELOMA, AND FAMILY
MEMBERS 8,653, A HUGE AGGREGATE
OF VERY CLOSE FAMILY MEMBERS TO
UNDERSTAND BETTER THE GENETICS
OF THESE PATIENTS.
NEXT SLIDE.
I JUST WANT TO GIVE SOME
HIGHLIGHTS, IT MATTERS TO SEE
AMAZING PARTICIPANTS, A FAMILY
OF NINE SIBLINGS JOINED,
NUMEROUS SETS OF TWINS, A TEAM
OF JANITORS AT A PUBLIC HIGH
SCHOOL WHO DECIDED TO GO
TOGETHER.
WE HAD ONE PATIENT WHO WAS AT
THE FURTHEST PART OF ALASKA, IT
TOOK TWO OR THREE PLANES TO GET
THAT BLOOD SAMPLE, BUT HE WAS
INSISTING HE WANTED TO BE PART
OF THE PROMISE STUDY.
THESE ARE THE CASES THAT REALLY
MATTER FOR US TO SEE IT DOES
MATTER FOR EVERY PARTICIPANT AND
FOR EVERYONE WHO WANTS TO BE
PART OF THE PROMISE STUDY.
NEXT SLIDE.
NOW I'LL SHOW SOME OF
[AUDIO DISTORTION]
WE'VE PUBLISHED, 3866 AFRICAN
AMERICANS, AND THEN -- SORRY,
2439 AFRICAN AMERICANS, AND
3,086 FIRST DEGREE FAMILY
MEMBERS.
NEXT SLIDE.
AND WHAT WE FOUND WAS VERY
INTERESTING.
WE SCREENED BY MASS
SPECTROMETRY, INSTEAD OF
SCREENING BY HAIR AND PROTEIN
ELECTROPHORESIS ONLY BECAUSE
IT'S MORE SENSITIVE.
IT'S A 50-YEAR-OLD TECHNOLOGY,
NOT SENSITIVE IN SMALL NUMBERS.
MASS SPECTROMETRY BY BINDING
SITE ALLOWS US TO IDENTIFY MGUS
AND ABOVE, WHICH IS ON YOUR LEFT
SIDE HERE, THE NUMBERS THAT ARE
ABOVE 1 GRAM, YOU CAN IDENTIFY
IMMUNOFIXATION POSITIVE ABOVE .2
GRAMS, FOUND ANOTHER 20% OF
CASES HAVING MONOCLONAL BELOW
THE FRACTION WE LEVEL WE FIND IN
IMMUNOFIXATION SO WE WANTED TO
MAKES SURE WE DON'T CALL THOSE
MGUS, OTHERWISE IT WILL CHANGE
THE PREVALENCE WE SEE IN GENERAL
AND TERM THIS A NEW TERM,
MONOCLONAL OF INDETERMINATE
POTENTIAL, AND I CAN SHOW HERE
THOSE ARE ALL CONFIRMED BY MASS
SPECTROMETRY, INDICATING INDEED
THEY WERE TRUE MONOCLONAL
PROTEINS, I'LL TALK ABOUT THAT
IN A SECOND.
SO AS WE SEE HERE THE
INCIDENCE -- PREVALENCE OF THOSE
PATIENTS INCREASED WITH AGE, AS
YOU CAN SEE, AND NUMBERS WERE
INCREASING WITH AGE BUT MGUS
KEEPS INCREASING MORE WITH AGE
AS WELL AS IN THE AFRICAN
AMERICAN COMMUNITY.
IF YOU LOOK AT NUMBERS WE'RE
SCREENING HIGH RISK POPULATION
GENERAL POPULATION HAS 3% OF
DEVELOPING MGUS AT AGE 50,
PEOPLE AT RISK HAVE DOUBLE THAT,
IF YOU LOOK BY MASS
SPECTROMETRY, MORE SENSITIVE,
EVEN AT THE SAME LEVEL OF MGUS,
.2 GRAMS, 13% OF PEOPLE WE
SCREENED ARE POSITIVE.
THAT'S NOT EVEN COUNTING OTHER
CASES.
THE QUESTION IS WHAT CAN WE DO
TO PREVENT MYELOMA IN THOSE
CASES?
NEXT SLIDE.
IN GENERAL WHEN WE LOOK AT MGB
CO-COURT WORSE OVERALL SURVIVAL
ASSOCIATED WITH ALSO CHANGES OR
ASSOCIATED WITH MORBIDITY, NOT
JUST MORTALITY, INCLUDING
HEMATOLOGIC MALIGNANCY AND
AUTOIMMUNE DISEASES, FOUND
INDEED IT WAS MUCH MORE COMMON
IN AFRICAN AMERICANS EVEN MGIB
CASES.
NEXT SLIDE.
THIS IS PRELIMINARY DATA THAT
CAME OUT LAST WEEK WHY IGI IS A
REAL MALIGNANCY THOSE WITH M GIP
AND MGUS, THEY ALL HAD INDEED
LYMPHOID MALIGNANCY WITH COPY
NUMBER ALTERATIONS, SO THIS
OPENS THE DOOR THAT WE'RE
SCREENING NOT ONLY FOR MYELOMA
BUT FOR MANY OTHER B CELL
MALIGNANCIES AND ASKING THE
QUESTION WHETHER WE'RE DETECTING
EARLY SOME AUTOIMMUNE DISEASES
PEOPLE HAVE WITH IMMUNE
DYSREGULATION.
IF WE DO NOTHING WE'RE REALLY
MAKING PEOPLE WORRY FOR A LONG
TIME AND WE'RE NOT MAKING ANY
BENEFIT FOR THOSE PATIENTS.
SCREENING SHOULD ONLY MATTER IF
WE CAN CHANGE SURVIVAL OF THOSE
PATIENTS SO BY DOING THAT ONE WE
WANT TO MAKE SURE WE'RE NOT
DETECTING MGUS THAT WILL BE NOT
CAUSING HARM VERSUS MGUS IN
SMOLDERING PATIENTS WHO WOULD
PROGRESS TO MYELOMA IN THEIR
LIFETIME, RISK STRATIFICATION,
AND SECOND THING OF COURSE IS
INTERCEPTION.
RISK STRATIFICATION IS CRITICAL
LOOKING AT GENOMIC
[AUDIO DISTORTION]
YOU CAN SEE WE HAVE PUBLICATION
A FEW YEARS AGO USING WHOLE
EXOME SEQUENCING, THREE GENOMIC
ALTERATIONS LEAD TO RAPID
PROGRESSION TO MYELOMA.
AND BY DOING THAT WE KNOW WE CAN
POTENTIALLY SCREEN OUR PATIENTS
FOR THOSE AND IF THEY DO HAVE IT
WE CAN CONSIDER THERAPY IN THEM.
NEXT SLIDE.
THIS IS A NEW METHOD THAT WE
JUST DEVELOPED, IT'S ONLINE
TODAY IN CANCER DISCOVERY.
[AUDIO DISTORTION]
BLOOD SAMPLES AND ISOLATING CAN
DO WHOLE GENOME SEQUENCING AND
IDENTIFY ALL OF THE
TRANSLOCATIONS THAT THOSE
PATIENTS HAVE SO NOT ONLY COPY
NUMBER ALTERATIONS OR MUTATIONS,
YOU CAN ALSO ADD IN THE MAIN
DRIVER EVENT, TRANSLOCATIONS IN
THOSE PATIENTS, CAN CALL IT OUT
IN THOSE PATIENTS.
NEXT SLIDE.
THIS SHOWS WE WERE ABLE TO
IDENTIFY IT IN EVERY SINGLE
PATIENT AS GOOD AS BONE MARROW
BIOPSY, EVEN MORE DATA WAS
OBTAINED IN PERIPHERAL BLOOD,
YOU CAN REPLACE FISH, A
TECHNOLOGY WE'VE BEEN USING, BY
USING CIRCULATING TUMOR CELLS,
WHOLE GENOME SEQUENCING, YOU CAN
REPLACE FISH AND BONE MARROW
BIOPSY ALLOWING IN THE FUTURE TO
BE ABLE TO SCREEN MANY MORE FOR
RISK AT DEVELOPING AT FASTER
PACE IN AFRICAN AMERICANS AND OF
COURSE IN THE GENERAL
POPULATION.
NEXT SLIDE.
IMMUNE CELL SEQUENCING, OVER 350
SAMPLES OVER THE LAST COUPLE OF
YEARS, I CAN SHOW INDEED THE
COMPOSITIONAL CHANGES OF THE
IMMUNE SYSTEM OCCUR AS EARLY AS
MGUS, SURPRISING TO US BECAUSE
WE SAW THE CHANGES WILL HAPPEN
IN SMOLDER MYELOMA AND MGUS IS
BENIGN, IN FACT WE FOUND EARLY
COMPOSITIONAL CHANGES HAPPEN AS
EARLY AS MGUS, HAS IMPLICATIONS
FOR PEOPLE WALKING AROUND
INCLUDING THOSE GETTING COVID
VACCINATION, WHETHER THEY ARE
RESPONDING TO VACCINE OR NOT.
THE QUESTION ALSO IS WHAT ARE
THE TRANSCRIPTIONAL CHANGES THAT
CAN HAPPEN IN THOSE PATIENTS AND
CAN WE IDENTIFY THEM NOT ONLY AS
BIOMARKERS BUT ALSO FOR
THERAPEUTIC INTERCEPTION, TCR
SEQUENCES, IMMUNE CELLS, CAN WE
DEFINE THEM FOR IMMUNOTHERAPY IN
THOSE PATIENTS.
NEXT SLIDE.
IN THE PERIPHERAL BLOOD TRYING
TO USE IT AS A MARKER DETECTING
WHO IS HEALTHY AND MALIGNANT.
IN EARLY DETECTION WE WANT TO
IDENTIFY IMMUNE CHANGES IN
PATIENTS AND WERE ABLE TO
ACTUALLY GET A CLASSIFIER THAT
TELLS HEALTHY INDIVIDUAL FROM
SOMEONE WITH MGUS FROM
PERIPHERAL BLOOD IMMUNE CELL
SEQUENCING AND POTENTIALLY USE
FOR OTHER
[AUDIO DISTORTION]
CAN WE USE OUR IMMUNE SYSTEM AS
A SENSOR FOR EARLY DETECTION NOT
ONLY FOR HEMATOLOGICAL
MALIGNANCY BUT ALSO OTHER
CANCERS, AND THAT COULD BE
CRITICAL FOR PANCREATIC, BREAST,
OTHER CANCERS WE SEE.
NEXT SLIDE.
AND THEN FINALLY INTERCEPTION,
CRITICAL.
IF WE DON'T INTERCEPT AND CHANGE
COURSE WE SHOULDN'T BE
SCREENING.
FIRST ATTEMPTS HAVE BEEN
PUBLISHED, WE KNOW PATIENTS WHO
RECEIVE TREATMENT CAN HAVE
IMPROVED SURVIVAL COMPARED TO
OBSERVATION AND HAVE MOVED TO
OTHER STUDIES IN SMOLDERING
MYELOMA ALSO BRINGING THEM TO
MGUS, THINKING OF IMMUNOTHERAPY
AS WELL AS SPECIFIC PRECISION
INTERCEPTION IN OUR PATIENTS, SO
SOMEONE WITH A TRANSLOCATION WHY
NOT USE
[AUDIO DISTORTION]
AND WE'RE TRYING TO DEVELOP
VACCINES NOW THAT VACCINE IS
AVAILABLE CAN WE DEVELOP
VACCINES FOR MGUS IN OUR
PATIENTS, IMMUNOTHERAPY SPECIFIC
FOR MGUS AND SMOLDERING MYELOMA
PATIENTS.
WE'RE ALREADY TAKING MANY DRUGS
APPROVED FOR MYELOMA, CAN WE
DEVELOP OUR OWN THAT CAN TRULY
INTERCEPT.
WITH ALL THE THAT, DEFINE
BIOMARKERS OF RESISTANCE.
NEXT SLIDE.
HERE ARE TWO EXAMPLES OF STUDIES
THAT ONE IS ALREADY OPEN.
WE HAVE ACCRUED SIX PATIENTS.
THIS IS IMMUNOPRISM, USING
BI-SPECIFIC ANTIBODIES INCLUDING
ONE RECENTLY APPROVED IN OUR
PATIENTS WITH SMOLDERING MYELOMA
AS FIRST LINE OF THERAPY AND
HAVE SEEN IMPRESSIVE RESPONSES
INDICATING IN DEED YOU WITH USE
ONE ANTIBODY, NO CHEMOTHERAPY,
NO COMBINATION AND ACHIEVE
AMAZING RESPONSES AS EARLY AS
SMOLDERING MYELOMA, THE HOPE IS
WE DON'T HAVE TO TREAT FOR A
VERY LONG TIME OR POTENTIALLY
THEY ACHIEVE LONG REMISSIONS.
WE ARE BRINGING CELLULAR THERAPY
INTO SMOLDERING MYELOMA BECAUSE
THE BEST TIME TO USE CAR T
THERAPY IS WHEN YOUR IMMUNE
SYSTEM IS BETTER THAN RELAPSE
SETTING, WITH LESS TUMOR BURDEN
COMPARED TO HEAVILY PRE-TREATED,
ASKING IN 20 PATIENTS THE FIRST
PATIENT HOPEFULLY TO BE ACCRUED
IN THE NEXT MONTH ON CAR T
THERAPY IN PEOPLE WITH
SMOLDERING MYELOMA, ULTRA HIGH
RISK, MINIMAL DISEASE BURDEN
LESS THAN 40% TO SEE IF WE CAN
HAVE CURATIVE INTENT IN THOSE
PATIENTS.
I WANT TO THANK YOU FOR THIS
OPPORTUNITY TO SHOW HOW IT
REALLY MATTERS TO CHANGE THE WAY
WE THINK OF MULTIPLE MYELOMA, A
DISEASE MORE COMMON IN AFRICAN
AMERICANS, AND CLOSE THAT GAP IN
UNDERSTANDING WHY DO WE HAVE A
WORSE SURVIVAL IN OUR PATIENTS
AND IMPROVING IT BY EARLY
DETECTION AND EARLY
INTERCEPTION.
I WANT TO THANK OF COURSE OUR
AMAZING MEMBERS IN THE LAB AND
CLINIC, MY COLLABORATORS AT THE
BROAD WHO DOES EVERYTHING WITH
ME AND OUR FUNDERS, STAND UP TO
CANCER, THE LUKE AND LYMPHOMA
SOCIETY, NCI, NIH, AND OUR
PATIENTS.
THANK YOU.
>>THANKS, IRENE.
QUESTIONS FOR DR. GHOBRIAL?
QUESTION, OTIS?
>>I WANT TO SAY THANK YOU FOR A
WONDERFUL TALK.
IT WAS REALLY GREAT.
I DON'T WANT TO TAKE ANYTHING
AWAY BUT BRING UP WHAT I CALL
THE WAKEFIELD, WHICH WAS BROUGHT
UP YESTERDAY.
I USED TO BE AT EMORY AND INDEED
RAN THE CANCER CENTER THERE FOR
A WHILE.
THERE ARE A SUBSTANTIAL NUMBER
OF PEOPLE IN METROPOLITAN
ATLANTA, ESPECIALLY BLACK
PEOPLE, BUT WHITES AS WELL, WHO
HAVE DIAGNOSED MULTIPLE MYELOMA
AND GET NO TREATMENT WHATSOEVER.
NOT OBSERVATION WHICH CAN BE
APPROPRIATE.
THESE ARE PEOPLE WHO CAN'T
AFFORD THE VERY EXPENSIVE DRUGS.
AND I THINK IT WOULD BE GOOD
ESPECIALLY SINCE WE HAVE A SEER
REGISTRY IN PLACES LIKE ATLANTA
AND DETROIT, I THINK IT WOULD BE
GOOD FOR THE NATIONAL CANCER
INSTITUTE TO DO STUDIES TO
ACTUALLY DEMONSTRATE THAT THERE
ARE SUBSTANTIAL NUMBER OF
AMERICAN PEOPLE WHO HAVE CANCER,
THAT IS TREATABLE, AND THEY GET
LESS THAN OPTIMAL TREATMENT OR
NO TREATMENT WHATSOEVER.
THANK YOU.
AGAIN, THAT WAS A SUPERB TALK.
>>THANK YOU.
I TOTALLY AGREE.
WE SHOULD DO MUCH BETTER THAN
THIS.
>>THANKS.
CHRIS, AND I SEE KAREN'S HAND.
>>THANK YOU FOR YOUR
PRESENTATION.
AS A HEMATOLOGIC HEMATOLOGIC MY
NURSE, THE PROGRESS IS
SUBSTANTIAL IN TERMS OF OUR
UNDERSTANDING, YET AS WAS NOTED
PROGRESS IS UNEQUALLY AND
UNEVEN, AND WE PLACE MYELOMA AS
PRIORITY FOR OUR NEXT FIVE
YEARS.
I WANTED TO COME BACK TO THE
POINT MADE, ONE OF THE
CHALLENGES HERE IS THAT THE
TREATMENT ADVANCES HAVE BEEN
PROFOUND, MANY COMPOUNDS ARE
ORAL AGENTS WHICH AS WE KNOW
CREATE STRUCTURAL INSURANCE
ISSUES THAT PATIENTS CANNOT
AFFORD THESE MEDICATIONS DESPITE
CO-PAYS AND THESE PROGRAMS, AND
THAT'S NOT AN ISSUE FOR YOU TO
SOLVE BUT I WANT TO HIGHLIGHT
THAT WE NEED A BETTER
UNDERSTANDING OF THOSE ISSUES
AND WE NEED TARGETED
INTERVENTIONS TO MAKE SURE THAT
PATIENTS CAN ACTUALLY RECEIVE
AND STAY ON THESE LIFE-SAVING
THERAPIES.
THANK YOU.
>>KAREN?
>>YEAH, SO, IRENE, ALWAYS A
PLEASURE TO SEE YOU.
WE WORKED TOGETHER FOR A VERY
LONG TIME ON THESE ISSUES.
I MUST SAY I'M VERY THRILLED
WITH THE PROGRESS YOUR TEAM HAS
MADE.
GOING GANG BUSTERS.
BUT, AGAIN, THE ELEPHANT IN THE
ROOM, YOU HAVE THIS COHORT OF
INDIVIDUALS NOW, I DO WONDER IF
THERE'S A WAY TO LAYER ON KIND
OF SOME FOCUS ON ECONOMICS,
PARTICULARLY FOR PATIENTS, YOU
KNOW, I LOOK AT A DRUG THAT
REVOLUTIONED THE WAY WE TREED,
IT WENT FROM $200 A PILL, OVER
$700 A PILL, RIGHT?
IF WE CAN COLLECT DATA ON
CO-PAYS, OTHER THINGS THAT MIGHT
PRESENT, I WONDER IF THAT'S
SOMETHING YOUR TEAM IS WORKING
ON OR SOME MIGHT BE ABLE TO BE
LAYERED ON THIS VERY UNIQUE
COHORT YOU'VE DEVELOPED BECAUSE
I DO WORRY A LITTLE BIT.
THIS IS THE SAME KIND OF THING
AS YESTERDAY WHEN SCREENING
WITHOUT ATTACHING TO TREATMENT
BUT ALSO THE FINANCIAL TOXICITY
PIECE THAT REALLY NEEDS TO BE
WOVEN INTO A LOT OF THESE
LONGITUDINAL STUDIES.
CAN YOU SPEAK TO THAT?
>>YES, YOU'RE RIGHT.
IT'S SO CRITICAL TO MAKE SURE
THAT IT'S NOT JUST SCREENING AND
TREATMENT THAT IS EXTREMELY
EXPENSIVE BUT
[AUDIO DISTORTION]
WE'RE TRYING TO DO A STUDY WHERE
WE SHOW THAT THERE IS A BENEFIT
OF EARLY TREATMENT BECAUSE ONCE
THE PATIENT IS DIAGNOSED WITH
MYELOMA, AND THEY ARE LOSING
THEIR JOB BECAUSE THEY HAVE TO
BE OUT OF WORK, BECAUSE THEY ARE
IN THE HOSPITAL FOR RENAL
FAILURE, THEY HAVE A FRACTURE OF
THEIR BONE, NOW THEY CAN NOT
WORK ANYMORE, OR THEY HAVE TO
HAVE TRANSPLANT, THINK OF ALL OF
THE ECONOMICS OF THAT.
SO WE'RE ACTUALLY TRYING TO SAY
EARLY INTERCEPTION, IT'S LESS
EXPENSIVE IN THE LIFETIME OF A
PATIENT WITH MYELOMA, COMPARED
TO A LIFETIME TREATMENT, FOR
YEARS AND YEARS MAINTENANCE
WITHOUT STOPPING THERAPY.
SO IF WE TREAT INTERCEPTION
EARLY, WE'RE DOING IT ONLY FOR
ONE OR TWO YEARS, OR WITH CAR T
ONCE AND YOU'RE DONE AND LEAVE
PATIENTS ALONE, NOW IT'S NOT
JUST ECONOMICS, IT'S THEIR LIFE.
I THINK OF IT AS THE WIFE OF A
PATIENT WHO HAD DIAGNOSIS OF
LYMPHOMA, THE WHOLE FAMILY IS
PULLED APART BECAUSE YOU GET
CANCER EVERYONE HAS TO THINK
ABOUT IT SO WE ALL HAVE THAT,
EVERYTHING FELL APART WHEN
PEOPLE ARE DIAGNOSED WITH
CANCER, AND EARLY DETECTION
GIVES THE BENEFIT, I CAN HAVE A
LITTLE BIT MORE CONTROL OF MY
LIFE, DECIDE WHEN I'M GOING TO
BE TREATED, IT'S NOT AN
EMERGENCY AND I'M NOT PULLING MY
FAMILY APART OR MY WORK OR THOSE
FACTORS.
YOU'RE LIGHT.
IT'S NOT JUST SURVIVAL.
IT'S THE ECONOMICS OF IT THAT
ARE IMPORTANT AND THE FAMILY
LIFE BALANCE THAT WE HAVE THERE.
>>THANKS, IRENE.
SUSAN?
YOU'RE MUTED.
WE CANNOT HEAR YOU.
OUTSTANDING, IRENE.
>>OH, PLEASE, YEAH.
>>GREAT PRESENTATION ON THE
SCIENCE.
MULTIPLE MYELOMA REPRESENTS ONE
OF THE CANCER ADVOCACY
COMMUNITIES, MMRF, THE RESEARCH
FOUNDATION, HOW DO WE RAISE UP
THESE PATIENT ADVOCACY
ORGANIZATIONS AND VIEW
SPECTACULAR SCIENCE.
ONE THING THAT IMPRESSED ME IS
DATA SHARING CAPABILITIES,
STRONG VOICES FROM THE PATIENT
COMMUNITY ON DATA SHARING, AND
TACKLING WHAT IS OBVIOUSLY AN
IMPORTANT DISEASE.
TELL ME HOW YOUR EFFORTS HAVE
PARTNERED WITH MMRF AND HOW THE
NCI CAN DO A BETTER JOB
PROMOTING PATIENT ADVOCACY IN
THE SPECTACULAR SCIENCE THAT IS
GOING ON.
>>YEAH, ABSOLUTELY.
THANK YOU, MICHAEL.
WE'VE WORKED CLOSELY WITH MMRF,
ALSO IMF AND STAND UP TO CANCER.
ALL OF THEM ARE WORKING HARD TO
MAKE SURE THE PATIENT IS HEARD
AND WE'RE GIVING THAT
EMPOWERMENT OF OUR PATIENTS
EARLY ON.
WE'RE NOW WORKING WITH THEM TO
DEVELOP
[AUDIO DISTORTION]
CONDITIONS, FIRST 1,000 PATIENTS
GENOMEICALLY IDENTIFIED AND
SEQUENCED, NOW WE'RE DEVELOPING
IT FOR MGUS AND SMOLDERING
MYELOMA SO WE WOULDN'T HAVE BEEN
ABLE TO DO THOUSANDS OF SAMPLES
WE'RE NOW COLLECTING WITHOUT
STAND UP TO CANCER OR SEQUENCE
300, OR 400 SAMPLES.
WITHOUT HELP AND PHILANTHROPY,
IT'S A COMMUNITY EFFORT, IT
NEEDS TO BE AN EFFORT PUT
TOGETHER.
WE CAN CANNOT DO WHICH WITH ONR
TWO MILLION DOLLARS OVER FIVE
YEARS.
IT NEEDS TO BE A HUGE EFFORT WE
REALLY CARE ABOUT.
LEUKEMIA AND LYMPHOMA SOCIETY IS
WORKING WITH US, MANY OTHERS
SAYING LET'S PUT THE EFFORT
TOGETHER, DIFFERENT FOUNDATIONS
WITH THE NCI HOPEFULLY AND WE
WORK TOGETHER TO MAKE THIS
HAPPEN.
BUT IT DOES REQUIRE A LOT OF
EFFORT AND ORGANIZING.
>>WE MAY HAVE TIME FOR ONE MORE
QUESTION FROM ANDY AND WE HAVE
TO MOVE ON.
>>THANKS.
TERRIFIC.
RELATED QUESTION TO MICHAEL'S,
YOU'VE BEEN SUCCESSFUL IN SORT
OF RECRUITING TO PROMISE ON THE
BASIS OF INTEREST IN MYELOMA AND
GETTING PATIENTS MOTIVATED BY
EARLY DETECTION THEME.
WHAT ARE YOUR THOUGHTS ABOUT
BROADENING THIS APPROACH TO
OTHER CANCERS AND THINKING ABOUT
TRYING TO MAKE SURE WE HAVE
EQUITABLE ENROLLMENT OF PEOPLE
TO MSED RELATED CLINICAL TRIALS,
HAVE YOU THOUGHT ABOUT THIS
COHORT FOR OTHER STUDIES?
>>WE MET TO EXPAND PROMISE INTO
ALL BLOOD CANCERS.
CHIP MUTATIONS CAN CAUSE NOT
ONLY LEUKEMIA BUT ALSO CAUSE
CARDIOVASCULAR DISEASE AND OTHER
THINGS.
WE'RE TALKING ABOUT WE'RE
ALREADY SCREENING FOR MDL AND
MSEDs, IT CAN BE DETECTED BY
IMMUNE CELL SEQUENCING, LOOKING
AT DANA-FARBER EARLY CANCER
SCREENING, WHETHER WE CAN ASK
THE QUESTION OF WHICH MSED
METHOD IS THE BEST.
THERE ARE AT LEAST TEN COMPANIES
OUT THERE, GRAIL AND OTHERS,
CLAIMING TO HAVE AMAZING METHODS
OF SCREENING AND WE NEED TO
REALLY HAVE AN EFFORT THAT'S PUT
TOGETHER WHICH INDEED THE NCI
[AUDIO DISTORTION]
WE'RE DOING IMMUNE CELL
SEQUENCING BUT ALSO HOW WOULD
THAT BE AVAILABLE FOR ALL OF THE
PEOPLE ESPECIALLY EQUITY IN
THOSE PEOPLE SO IT'S NOT ONLY
THE RICH AND WEALTHY PEOPLE WHO
CAN GET IT.
IT'S EVERYONE GETTING MSED
DETECTION, FOR PROMISE WE'RE NOW
EXPANDING TO BLOOD CANCERS, EASY
LOW-HANGING FRUIT AND HOPEFULLY
CAN USE THE SAME INFRASTRUCTURE
IF WE OPEN IT INTO, YOU KNOW,
THE PHARMACIES NEARBY SO YOU
DON'T HAVE TO GO TO THE DOCTOR,
WE CAN GET IT TO NATIONWIDE ON
YOUR PHONE, DIRECT TO PATIENT
ACCESS, ALL THOSE METHODS USED
FOR THE CANCER SCREENING.
>>THANKS FOR THAT INFORMATIVE
PRESENTATION TO THE BOARDS.
SO LET'S MOVE ON TO THE NEXT
AGENDA ITEM, WHICH IS REPORT
FROM THE NCAB WORKING GROUP, AD
HOC WORKING GROUP REPORT ON
STRATEGIC APPROACHES AND
OPPORTUNITIES FOR RESEARCH ON
CANCER AMONG RACIAL AND ETHNIC
MINORITIES AND UNDERSERVED
POPULATIONS, BROUGHT TO US BY
THE CO-CHAIRS, DOCTORS PASKETT,
DOUBENI, AND MARTINEZ.
>>THANK YOU.
DR. MARTINEZ IS JOINING US, SHE
WILL BEGIN THE PRESENTATION
TODAY.
>>HELLO.
PART OF THE PRESENTATION.
THANK YOU, ELECTRA.
IT'S A PLEASURE TO BE HERE.
I WANT TO START BY SAYING IT'S
BEEN AN HONOR TO SERVE AS
CO-CHAIR OF THIS WORKING GROUP,
AND GLAD TO BE PRESENTING A
SYNOPSIS OF THE REPORT.
I'LL KEEP MY PART BRIEF TO GET
TO THE RESULTS AND
RECOMMENDATIONS PRESENTED BY
ELECTRA.
NEXT SLIDE PLEASE.
SO I WANT TO REMIND EVERYONE OF
WHAT THE CHARGE WAS TO THE
WORKING GROUP.
I'M NOT GOING TO READ IT,
REITERATE THAT WE WERE HERE, PUT
TOGETHER, AS A WORKING GROUP,
OPPORTUNITIES FOR RESEARCH.
I WANT TO UNDERLINE THAT
RESEARCH, ON CANCER ALONG RACIAL
AND ETHNIC MINORITIES AND
UNDERSERVED POPULATIONS.
AMONG THE RECOMMENDATIONS WE
WERE ALSO TO EVALUATE THE
CURRENT STATUS OF THE NCI OR NIH
PORTFOLIO AND IDENTIFY NEW
POTENTIAL STRATEGIC APPROACHES
AND ACTIONS TO IMPLEMENT THESE.
NEXT SLIDE PLEASE.
AFTER THIS DISCUSSIONS WITH THE
WORKING GROUP, EARLY IN THE
PROCESS, WE IDENTIFIED THESE
SPECIFIC GROUPS TO FOCUS ON.
YOU SEE THEM LISTED HERE, BLACK
OR AFRICAN AMERICAN, HISPANIC
LATINO, AMERICAN INDIAN/ALASKA
NATIVE, ASIAN AND PACIFIC
ISLANDERS, RURAL POPULATIONS,
OLDER ADULTS, LGBTQ, AYA CANCER
SURVIVORS.
WE RECOGNIZE DISTINCT AND SHARED
INEQUITIES AND DISPARITIES FACED
BY EACH GROUP.
AND IT WAS IMPORTANT FOR US TO
UNDERSTAND THAT AND REITERATE
THIS AND DESCRIBED SOME OF THESE
IN THE REPORT.
NEXT SLIDE PLEASE.
AS YOU HEARD, THE WORKING GROUP
WAS CO-CHAIRED BY ELECTRA AND
MYSELF.
I WANT TO RECOGNIZE THE MEMBERS
OF THE WORKING GROUP, NAMES
SHOWN HERE ON THE RIGHT.
THESE ARE EXTREMELY BUSY PEOPLE
WHO MADE TIME TO WORK ON THIS
IMPORTANT TASK.
THANK YOU TO ALL OF YOU.
I WANT TO THANK DR. PHIL CASTLE,
AND HIS TEAM FOR HELPING US OUT.
THE WORKING GROUP FOR OVER A
YEAR, YEAR AND A HALF, JULY
2021, A LONG PERIOD OF TIME.
WE WANTED TO MAKE SURE WE TOOK
ENOUGH TIME TO BE ABLE TO MEET
THE CHARGE OF THE TASKS.
FIRST MONTHLY MEETING IS JULY
2021, AND THIS MEETING WAS
ACTUALLY ATTENDED BY DR.
SHARPLESS, WHO PROVIDED US WITH
THE CHARGE, AND TOLD US NOT TO
TRY TO BOIL THE OPTION, I DO
RECALL THAT.
MONTHLY CO-CHAIR MEETINGS TOOK
PLACE WITH VERY IMPORTANT
SPEAKERS INCLUDING MEMBERS OF
THE CENTER FOR RESEARCH
STRATEGY, INSTRUMENTAL IN MAKING
ANALYSIS POSSIBLE.
WE ALSO HAD PRESENTATIONS FROM
KEY NCI INDIVIDUALS WHO
PRESENTED INCLUDING DR.
SRINIVASEN AND DR. SPRINGFIELD.
THANK YOU TO ALL OF YOU.
HERE IS THE OUTLINE OF THE
REPORT.
YOU'RE FAMILIAR WITH THE
FORMATS, WE'LL GET THROUGH AS
MANY OF THESE AS POSSIBLE IN THE
NEXT FEW SLIDES.
OKAY.
NEXT SLIDE PLEASE.
LET'S GET TO THE REPORT.
NEXT SLIDE.
IT WAS IMPORTANT FOR THE WORKING
GROUP, ALL OF US, TO GET ON THE
SAME PAGE WITH THE TERMINOLOGY
INCLUDING WHAT WE MEANT BY
DEFINITION OF DISPARITIES,
DEFINITION OF HEALTH
DISPARITIES, A COUPLE PROVIDED
HERE.
I WON'T READ THROUGH THEM.
THE WORKING GROUP RECOGNIZED
EARLY ON THERE WERE SEVERAL
MULTI-LEVEL FRAMEWORKS THAT SOME
OF YOU IN THE ROOM AND THE ZOOM
ARE VERY FAMILIAR WITH.
AND THAT HAVE BEEN DEVELOPED TO
SUPPORT AND GUIDE INTERVENTIONS
AND OTHER STRATEGIES TO ENHANCE
CANCER OUTCOMES, ELIMINATE
DISPARITIES, ACHIEVE HEALTH
EQUITY AMONG POPULATIONS THAT
EXPERIENCE THESE.
AND THE REPORT WE PROVIDED A
BRIEF OVERVIEW OF SOME OF THESE
FRAMEWORKS.
NEXT SLIDE PLEASE.
NOW, IN ORDER TO IDENTIFY GAPS
FOR PRIORITIZATION, THE WORKING
GROUP DECIDED TO EXAMINE
RESEARCH ACROSS THE CONTINUUM,
FOR THE POPULATIONS AS YOU CAN
SEE HERE.
NCI USE US THE CONTINUUM, WE
FELT THIS WAS AN IDEAL WAY TO
TACKLE THIS CHALLENGE OF THE
REPORT AND ADDRESSING THE
CHARGE.
I THINK THIS HAS PROVIDED A
GREAT WAY TO ASSESS THE GAPS AND
RESULTED IN SOME VERY
INTERESTING FINDINGS THAT
ELECTRA WILL PRESENT IN A
SUBSEQUENT SLIDE.
NEXT SLIDE PLEASE.
I WANT TO REMIND EVERYBODY OF
THE METHODOLOGY THAT THE CRS
TEAM USED TO CONDUCT THE
ANALYSIS.
WE PRESENTED THIS INFORMATION
BEFORE TO YOU ALL SO I'M NOT
GOING OVER IT IN TOO MUCH DETAIL
BUT, AGAIN, I WANT TO THANK,
AGAIN, THE AMAZING CRS TEAM FOR
THEIR GREAT WORK.
NEXT SLIDE PLEASE .
HERE A SYNOPSIS OVERVIEW OF THE
CRS APPROACH USED TO IDENTIFY
CANCER RESEARCH RELEVANT TO THE
WORKING GROUP'S POPULATIONS OF
INTEREST SHOWN ON THE SLIDE.
THIS APPROACH I WANT TO REMIND
EVERYBODY RELIED ON MACHINE
LEARNING ALGORITHMS,
SUPPLEMENTED BY SOME MANUAL
CURATION, THAT RESULTED FROM
SPECIFIC DECISIONS MADE BY THE
WORKING GROUP.
THE PROCESS BEGAN WITH
IDENTIFYING FY 21 NIH GRANTS,
THEN THESE WERE FILTERED TO
IDENTIFY CANCER-SPECIFIC
RESEARCH GRANTS.
THEN IDENTIFYING RESEARCH OF
INTEREST, RCDC, SOUNDS LIKE A
ROCK BAND BUT IT'S NOT.
RCDC.
WE HAVE A SLIDE SHORTLY THAT
DESCRIBES THIS APPROACH.
THERE WERE BACK AND FORTH
DISCUSSIONS RESULTING IN MANUAL
CURATION TO COME UP WITH FINAL
LIST OF GRANTS, A LOT OF WORK
TOOK PLACE BY THE CRS GROUP.
THANK YOU.
EXCLUSION CRITERIA WAS DEVELOPED
TO MAKE SURE WE WOULD NOT DOUBLE
COUNT.
THIS TOOK A FAIR AMOUNT OF BACK
AND FORTH, A LOT OF DISCUSSIONS
WITH THE WORKING GROUP.
THIS SLIDE PROVIDES A LIST OF
THE TYPES OF GRANTS AND GRANT
CATEGORIES EXCLUDED.
YOU HAVE THEM LISTED HERE.
THESE INCLUDED ALSO
INTERNATIONAL PROJECTS BECAUSE
WE FELT THAT OUR CHARGE WAS TO
ADVISE ON THE STRATEGIC
APPROACHES AND OPPORTUNITIES
RELATED TO RACIAL AND ETHNIC
MINORITIES AND UNDERSERVED
POPULATIONS IN THIS COUNTRY.
NEXT SLIDE PLEASE.
HERE'S AN OVERVIEW OF THE SYSTEM
USED BY NIH, IN ITS REPORTING
PROCESS, TO CATEGORIZE THE
FUNDING AND BIOMEDICAL RESEARCH
FOR EACH FISCAL YEAR BY
PROVIDING CONSISTENT TEXT MINING
METHODS APPLIED TO ALL THESE
CATEGORIES EACH YEAR, FOR
CATEGORIZATION AND REPORTING ON
NIH FUNDING.
JUST TO EMPHASIZE WE USES
EXISTING NIH APPROACH.
IF YOU WANT TO READ MORE HOW
THIS WORKS, THE WEBSITE FOR
THESE IS FOUND ON THE SLIDE.
NEXT SLIDE PLEASE.
AND THE FINAL SLIDE FOR THE
METHODS IS SHOWN HERE, JUST TO
NOTE THE INTERNATIONAL CANCER
RESEARCH PARTNERSHIP HAS A SET
OF CODING GUIDELINES REFERRED TO
AS THE COMMON SCIENTIFIC
OUTLINE, CSO, USED TO ASSESS
RESEARCH PORTFOLIOS.
SO GRANTS ARE CATEGORIZED INTO
CSO CODES USING MACHINE LEARNING
MODEL, ASSIGNED INTO CATEGORIES
NOTED ON THE SLIDE.
WE WANT TO NOTE IN SOME
INSTANCES THERE WAS NOT ENOUGH
INFORMATION TO ASSIGN A GRANT TO
A PARTICULAR CATEGORY, AND
ELECTRA IS GOING TO PROVIDE MORE
INFORMATION ABOUT THAT SPECIFIC
LIMITATION AND NOW I'M GOING TO
TURN IT OVER TO ELECTRA.
>>THANK YOU VERY MUCH, ELENA.
I WANT TO ECHO THE THANKS THAT
ELENA HAS ALREADY STATED TO THE
TEAM IN ALL THE HARD WORK.
I'M GOING TO GO NOW OVER THE
RESULTS IN THESE CATEGORIES, AND
KEEP IN MIND THE METHODOLOGY
THAT ELENA JUST PRESENTED AS IT
WILL HELP.
NEXT SLIDE PLEASE.
FIRST WE'LL LOOK AT THE FISCAL
21 PORTFOLIO.
THIS IS SORT OF HOW EVERYTHING
WAS DONE.
WE TOOK THE -- WE TOOK THE
FISCAL YEAR CANCER GRANTS OF ALL
OF NIH FOR 21.
AND USED THE RCDC CODE TO
IDENTIFY CANCER GRANTS.
AND WITH -- CAME UP WITH ABOUT
9600 BASE PROJECTS, WHICH 75%
WERE FROM NCI FOR A TOTAL OF
ABOUT 7200 PROJECTS.
WE THEN ADDED EXCLUSION CRITERIA
ALREADY DISCUSSED, AND WE CAME
UP WITH ABOUT NIH CANCER
RESEARCH PORTFOLIO OF 7300 BASE
PROJECTS, 74%, WHICH WERE NCI,
AND THEN WE INCLUDED OUR RCDC
CATEGORIES AND CONCEPTS FOR THE
POPULATION OF INTEREST TO COME
UP WITH WHAT YOU'LL SEE THE
FISCAL YEAR 21 NIH CANCER AND
POPULATION OF INTEREST BASE
PROJECTS AND THEN THE PERCENT
WHICH ARE NCI.
SO I'M NEXT GOING TO MOVE INTO
ACTUALLY SHOWING YOU SOME DATA.
SO IT WILL HELP WITH THE
EXPLANATION THAT I JUST GAVE.
NEXT SLIDE PLEASE.
SO, THIS IS THE FISCAL YEAR 21
EXTRAMURAL BASE PROJECT FOR
POPULATIONS OF INTEREST.
YOU CAN SEE THE FURTHERMOST LEFT
COLUMN HAS OUR POPULATIONS, AND
THEN TAKING THOSE BASE PROJECTS
FROM ALL OF NIH REMEMBER THE
TOTAL WAS 7327, WE PRESENT TO
YOU THE NUMBER CONDUCTED AMONG
POPULATIONS OF INTEREST, AND THE
FIRST YOU CAN SEE IS 310 OF
THOSE 7327 PROJECTS WERE
INDICATED TO BE CONDUCTED AMONG
BLACK OR AFRICAN AMERICAN
PARTICIPANTS.
AND THAT IS 4.23% OF THE TOTAL
NIH GRANTS.
IF YOU MOVE OVER TO THE NEXT
COLUMN, WE LOOK AT THOSE BASE
PROJECTS ADMINISTERED BY NCI,
TOTALS 5212, THERE WERE 246 OF
THE 310, 79%, BUT IF WE LOOK AT
THE TOTAL OF THOSE ADMINISTERED
BY NCI 5412 THAT REPRESENTS
4.55%.
YOU CAN SEE THE NUMBERS AS YOU
GO DOWN, EACH OF THE COLUMNS,
AND THE RELATIVE -- THE
ESTIMATED PERCENT THAT WE HAVE
FOR YOU.
NEXT SLIDE.
NOW, THIS ONE SHOWS YOU AGAIN
FISCAL YEAR 21 NIH PORTFOLIO
BASE PROJECT BUT CLASSIFIED
WITHIN THOSE CSO CATEGORIES
WHICH WAS THE CLOSEST WE COULD
GET TO THE CANCER CONTINUUM THAT
ELENA SHOWED YOU WHICH WAS OUR
DESIRE TO SHOW RESEARCH IN EACH
OF OUR POPULATIONS OF INTEREST
ACROSS THE CANCER CONTINUUM.
THE CONTINUUM IS THE FIRST
COLUMN ON THE LEFT.
AND I'LL GO THROUGH THE
COMPARATOR FOR YOU BECAUSE THIS
IS THE COMPARATOR.
SO FOR -- IN BIOLOGY AWARDS, OR
AWARDS FOCUSING ON BIOLOGY,
THERE ARE 42% OF NIH GRANTS THAT
FOCUS ON BIOLOGY.
12.9 ON ETIOLOGY, ET CETERA.
NOW, IF WE COMPARE AMONGST THE
310 PROJECTS THAT WERE CONDUCTED
AMONG BLACK OR AFRICAN AMERICAN
POPULATIONS, 26.5% OF THOSE 310
WERE CATEGORIZED AS FOCUSING ON
BIOLOGY.
YOU CAN SEE DOWN EACH AND ACROSS
THE COLUMNS.
WE NOW HAVE THESE PICTORIALLY,
AND I JUST PICKED TO SHOW YOU
BLACK OR AFRICAN AMERICAN
POPULATION, YOU CAN SEE THESE
BETTER IF YOU LIKE THINGS
VISUALLY.
GRAY LINE IS THE NIH CANCER
COMPARATOR, RED LINE IS THOSE
PERCENT OF THE 310 BASE PROJECTS
THAT ARE WITH BLACK OR AFRICAN
AMERICAN POPULATIONS, AND YOU
CAN SEE WHERE THERE ARE
DIFFERENCES IN BIOLOGY AND
TREATMENT.
FOR SAKE OF TIME AND YOUR EYES
TO SEE THESE WE'RE NOT SHOWING
THE OTHER GRAPHS BUT THE PATTERN
IS THE SAME, THAT THE BIOLOGY
AND THE TREATMENT RESEARCH IS
NOTICEABLY LESS, IN ALL OF THE
POPULATION GROUPS THAT WE
EXAMINED.
NEXT SLIDE PLEASE.
SO NOW I WANT TO GO TO OUR
SUMMARY AND RECOMMENDATIONS.
NEXT SLIDE.
THIS IS A SUMMARY OF OUR
FINDINGS.
AS YOU CAN SEE, THERE IS AN
IMBALANCE IN RESEARCH RELATIVE
TO THE DISTRIBUTION OF CANCER
DIAGNOSIS, MORBIDITY AND DEATH,
IN THE UNITED STATES.
AND RELATIVE TO THE OVERALL
PORTFOLIO, THE NIH COMPARATOR,
INVESTMENT WAS SMALL FOR
RESEARCH THAT FOCUSED AMONG THE
RACIAL/ETHNIC MINORITIES, RULE
POPULATIONS, OTHER GROUPS
EVALUATED.
UNDERREPRESENTATION WAS AMONG
CONTINUUM OF SCIENCE, CSO CODES,
AND LIFESPAN.
WE ALSO FOUND AS WE SHOWED YOU
THAN THERE WERE MORE PROJECTS IN
POPULATION SCIENCE, FEWER
STUDIES IN BIOLOGICAL RESEARCH
AND CLINICAL RESEARCH.
MANY OF THE PROJECTS REALLY DREW
ON A LIMITED NUMBER OF
UNDERSERVED POPULATION GROUPS,
LIMITING THE APPLICABILITY OF
CURRENT KNOWLEDGE BASE, AND
INFORMATION WAS LACKING OR NOT
AS IN DEPTH FOR SOME POPULATIONS
BECAUSE OF LIMITED DISAGGREGATED
DATA.
ELENA EXPLAINED THAT WE
DISAGGREGATED ASIAN AND PACIFIC
ISLANDER POPULATIONS, FOR
EXAMPLE, AND THERE REALLY WAS
NOT AS MUCH DATA IN THOSE
POPULATIONS.
OTHER POPULATIONS WERE
UNDERSTUDIED, LGBTQ+ POPULATION,
OR POPULATION WAS NOT ADEQUATELY
IDENTIFIABLE AS A DISTINCT GROUP
IN CURRENT RESEARCH INVENTORY
NCI MEETING WE DIDN'T HAVE CODES
SO WE COULDN'T PULL THOSE
RESEARCH GRANTS OUT OF THE
DATABASE.
FOR EXAMPLE, THE AYA POPULATION
AND OLDER ADULTS.
THIS LIMITED WORKING GROUP'S
ABILITY TO COMPLETE THE CHARGE
TO THE SAME DEGREE FOR ALL OF
THE POPULATIONS, THAT WE WERE
EXAMINING.
NEXT SLIDE PLEASE.
NOW I'M GOING TO RECOMMENDATIONS
IN TWO CATEGORIES, SPECIFIC AND
THEN THE BROAD RECOMMENDATIONS.
SPECIFICALLY, TO EXPAND AND/OR
INITIATE RFAs, FOAs,
INVESTIGATOR INITIATED AWARDS,
SUPPLEMENT OPPORTUNITIES IN
AREAS WITH INTENTIONAL FOCUS ON
ELIMINATING DISPARITIES AND
INEQUITIES IN THE FUNDED GRANT
PORTFOLIO.
NUMBER ONE IS MORE FUNDING FOR
ALL OF THOSE POPULATION GROUPS.
SECONDLY, IN THE AREA OF DATA
COLLECTION, WE RECOMMEND THAT
THERE IS A STANDARDIZED CHECK
LIST THAT IS ADOPTED FOR GRANTS
THAT WILL IDENTIFY POPULATIONS
THAT ARE INCLUDED, BEING
STUDIED, SET STANDARDS IN
REPORTING OF DISAGGREGATED DATA
FOR ALL RACES AND ETHNICITIES.
THIRD IN THE AREA OF MONITORING
AND EVALUATION, DEVELOP
EFFECTIVE AND EFFICIENT
STRATEGIES FOR TRACKING,
MONITORING, EVALUATING FEDERAL
INVESTMENT IN ADVANCING CANCER
HEALTH EQUITY TO ADDRESS GAPS IN
HEALTH DISPARITIES IDENTIFIED IN
THIS REPORT.
WE CAN'T MEASURE WHO WE'RE DOING
UNLESS WE HAVE A STRATEGY TO DO
THIS AUTOMATICALLY.
AND IF WE CAN MEASURE IT AND
EVALUATE IT, WE NEED TO THEN
REPORT IT.
AND CREATE ANNUAL REPORT
ACTIVITIES TO PROVIDE
CONGRESSIONAL BRIEFINGS ON THE
STATE OF CANCER HEALTH EQUITY.
NEXT SLIDE PLEASE.
OUR BROAD RECOMMENDATIONS
INCLUDE SETTING -- ESTABLISHING
SET OF GUIDING PRINCIPLES AND
PRIORITIES USING THESE
RECOMMENDATIONS, UTILIZE A
FRAMEWORK FOR RESEARCH THAT
RELATES TO THE SCIENCE, ART AND
PRACTICE OF INCLUSIVE CANCER
RESEARCH, IMPLEMENT STRATEGIES
TO INCREASE FUNDING TO DIVERSE
AND UNDERREPRESENTED
INVESTIGATORS, ENSURE A PORTION
OF THE GRANTS IS FOCUSED ON THIS
POPULATIONS WE INCLUDED IN THE
REPORT, IMPLEMENT A SET OF CORE
ELEMENTS TO FACILITATE ANALYSIS
AND REPORTING OF PROGRESS IN
RESEARCH ACROSS THE CONTINUUM BY
EACH OF THE POPULATIONS, AND,
AGAIN, INTENTIONALITY,
ACCELERATE RESEARCH IN THESE
AREAS BY OFFERING RFAs,
FOAs, PARS TO UNDERSTAND WHY
THERE ARE DISPARITIES AND HOW TO
ELIMINATE DISPARITY.
AND THEN LASTLY OUR
RECOMMENDATIONS CAN ONLY BE
FULLY REALIZED WHEN WE WORK WITH
OTHER ONGOING NCI EFFORTS,
SPECIFICALLY IN TRAINING.
SO THAT WE CAN INCREASE
DIVERSITY IN THE WORKFORCE AT
ALL LEVELS.
SO I WOULD LIKE TO CONCLUDE AND
SAY THAT IN POPULATION GROUPS
WHERE WE SEE DISPARITIES IN
CANCER HEALTHS OUTCOMES, WE SEE
DISPARITIES IN FUNDING.
THANK YOU VERY MUCH.
DR. DOUBENI IS ALSO ON.
SO THE THREE OF US, AND I KNOW
DR. CASTLE IS ALSO ON, WE'RE
HAPPY TO TAKE QUESTIONS.
MAYBE WE CAN TAKE THIS DOWN SO
WE CAN SEE THE QUESTIONS.
THANKS VERY MUCH.
>>WE HAVE FIVE MINUTES FOR
QUESTIONS.
CURRENTLY I SEE ANDREA AND MARK,
AND GLORIA.
LET'S GO IN THAT ORDER.
>>THANK YOU FOR THAT THOROUGH
EVALUATION ASSESSMENT AND
EXCELLENT JOB.
THE ONLY COMMENT I HAVE IS
REGARDING THE GRANTS AND IT MAY
BE SORT OF BETWEEN THE LINES BUT
WASN'T SPELLED OUT, EMPHASIS ON
YOUNG INVESTIGATOR, I SAW R01
AND SUPPLEMENT OPPORTUNITIES,
SUPPLEMENT OPPORTUNITIES IS ONE
OF THE MECHANISMS BUT WANT TO
MAKE SURE SOMEWHERE IN THE
DETAILS WE ARE ENCOURAGING
YOUNGER INVESTIGATORS.
>>THANKS, IN THE
RECOMMENDATIONS, THANKS VERY
MUCH, YES.
APPRECIATE THAT.
>>GREAT POINT.
MARK?
>>THANKS.
EXCELLENT PRESENTATION.
I JUST WANT TO POINT OUT ONE
SPECIFIC ISSUE BUT I THINK IT
NEEDS ATTENTION AND THIS
COMMITTEE MAY WANT TO ADDRESS
THIS TO SOME EXTENT.
THE AMERICAN INDIAN AND ALASKA
NATIVE POPULATION, AN INDIVIDUAL
SAY ON A THERAPEUTIC TREATMENT
TRIAL OR BIOLOGY STUDY, AND
YOU'RE NOT WITHIN THE INDIAN
HEALTH SERVICE TRIBAL OR URBAN
INDIAN HEALTH CENTER SETTING,
THAT COULD BE INDIVIDUAL
CONSENT, BUT IF YOU'RE WORKING
WITHIN THE INDIAN HEALTH SERVICE
TRIBAL OR URBAN INDIAN CLINIC
SETTING, THEN YOU ARE DEALING
WITH DOMESTIC TRIBAL SOVEREIGN
NATIONS AND DATA SOVEREIGNTY
ISSUES.
AND SO, YOU KNOW, THERE IS A
SPECIAL FEDERAL TRIBAL
RELATIONSHIP THAT NEEDS TO BE
CONSIDERED IN RELATION TO
RESEARCH.
NCI IS AWARE OF THIS.
WHEN YOU TALK ABOUT
DISAGGREGATED DATA THERE HAS TO
BE ALLOWANCES FOR DATA SHARING
AGREEMENTS THAT CAN ACCOMMODATE
TRIBAL SOVEREIGNTY AS WELL SO I
WANT TO MAKE SURE THAT THAT GETS
INCORPORATED INTO HOW THIS WAS
CONCEPTUALIZED.
THE OTHER QUICK POINT IS I
BROUGHT THIS UP I THINK
YESTERDAY, RURAL IN TERMS OF
BEING CLEAR ABOUT DEFINITIONS,
WHAT COUNTS, THIS WOULD BE TRUE
FOR OTHER GROUPS AS WELL.
I THINK DEFINITIONAL CLARITY IS
GOING TO BE IMPORTANT BECAUSE
PEOPLE MAY SELF-REPORT THINGS
THAT AREN'T --
>>RIGHT, MARK, WHEN WE DID OUR
ANALYSIS WE DID USE OUR RUCC
CODE.
>>GLORIA?
>>GREAT PRESENTATION.
THANKS FOR ALL THE WONDERFUL
WORK.
A QUESTION THAT RELATES TO YOUR
RECOMMENDATION FOR REPORTING OR
TRACKING AND REPORTING.
SO RECENTLY ON A NATIONAL
ACADEMIES COMMITTEE ON IMPROVING
REPRESENTATION IN CLINICAL
TRIALS AND RESEARCH, WE FOCUSED
ON IMPROVING REPORTING IN
clinicaltrials.gov SPECIFICALLY
BECAUSE IT'S DIFFICULT TO UNDER
REPRESENTATION FROM DATA THAT'S
AVAILABLE IN
clinicaltrials.gov.
I WONDERED IF THIS COMMITTEE HAD
SIMILAR THOUGHTS ABOUT
clinicaltrials.gov BEING THE
RIGHT PLACE FOR THAT OR DID YOU
REALLY THINK ABOUT IT BEING IN A
DIFFERENT PLACE LIKE NIH
REPORTER OR SOME OTHER EXISTING
TRACKING SYSTEM?
>>OBVIOUSLY WE DIDN'T CONSIDER
THAT.
ELENA, DO YOU WANT TO ADD?
WE STILL HAVE MORE TO GO IN
TERMS OF WHERE THAT WOULD
REPORTING BE.
DO YOU WANT TO --
>>YEAH, I THINK THAT'S A VERY
IMPORTANT AND CRITICAL QUESTION,
WITHOUT MEASURING AND TRACKING,
OBVIOUSLY SOMEBODY --
RECOMMENDATIONS OF INCLUSIVE
RESEARCH ARE IMPORTANT TO TRACK.
RIGHT NOW WE ALL AGREE CURRENT
SYSTEMS ARE INADEQUATE, WHAT WE
RECOMMENDED IS A CHECKLIST
SYSTEM THAT ALLOWS FOR SYSTEMS
TO TRACK PERSPECTIVELY.
WE HAVEN'T DONE THE DEEP DIVE TO
SEE WHAT'S IN PLACE AND WHAT
YOU'RE PLANNING TO DO, CLEARLY
WANT TO FLAG THAT AS SOMETHING
IMPORTANT NCI NEEDS TO CONSIDER.
>>LET ME ADD SOMETHING.
WE DID TALK ABOUT ADDING A CHECK
BOX THAT WOULD BE WHEN THE GRANT
WAS SUBMITTED THAT THERE WOULD
BE A CHECK BOX AT THAT POINT,
THAT WOULD BE AN NIH CHECK BOX,
NOT NECESSARILY A CHECK BOX THAT
WOULD BE AT NCI LEVEL.
>>CORRECT, YES.
>>EXACTLY WHAT I WAS GOING TO
SAY.
>>PAULETTE, DO WE NEED TO VOTE?
>>YES.
ONCE THE DISCUSSION IS FINISHED
WE'RE AT 2:05, I'M SUPPOSED TO
HAND OFF TO KEITH.
I WAS THINK WE GO SHOULD VOTE
NOW.
>>MOVE APPROVAL.
>>SO DO WE HAVE -- IS THERE A
MOTION TO ACCEPT THE REPORT?
>>SO MOVED.
>>SECOND?
>>SECOND.
>>ANY NAYS?
ABSTENTIONS?
>>I'M GOING TO ABSTAIN BECAUSE
I DON'T KNOW ENOUGH ABOUT THE
PROCESSING OF TEXT AND HAVE
CONCERNS THAT THE AI/ML WAS
APPLIED TO STRUCTURE DATA, HARD
TO BELIEVE THAT THERE WASN'T
BIAS IN THIS DATASET SO I JUST
AM GOING TO ABSTAIN FROM THIS
ONE AS A MINORITY REPORT.
>>PAULETTE, YOU NOTE IT?
>>I HAVE IT.
>>IT'S BEEN PROPERLY MOVED AND
SECONDED.
IT'S NOT UNANIMOUS BUT --
>> I THINK IT'S, WHAT, I HAVE
THE NUMBER, I GAVE IT TO YOU.
>>GREAT.
>>THANKS.
>>FANTASTIC.
IF THERE WERE ANY OTHER COMMENTS
OR QUESTIONS FEEL FREE TO SEND
THEM OVER TO PAULETTE AND SHE
CAN WORK WITH THE WORKING GROUP
AND SUBCOMMITTEE TO ADDRESS
THOSE ISSUES.
SO I THINK NOW I HAND THE
MEETING OVER TO KEITH.
>>THE VOTE WAS APPROVAL WITH
ONE ABSTENTION.
>>ONE ABSTENTION.
>>RIGHT.
OKAY.
>>OKAY.
THANK YOU, JOHN.
WE WILL PICK UP WHERE WE LEFT
OFF YESTERDAY.
FOUR CONCEPTS TO DISCUSS IN THE
REMAINDER OF THE BSA COMPONENT
OF THIS MEETING.
TWO NEW, TWO REISSUE CONCEPTS
FOR THE BOARD'S CONSIDERATION.
AS IN PRIOR MEETINGS, AND
YESTERDAY BSA MEMBERS HAVE BEEN
ASSIGNED.
IF A REISSUE, FOR TWO WE'LL BE
DISCUSSING TODAY, VOTE WILL BE
TO CONCUR, NON-CONCUR, DEFER, OR
ABSTAIN.
AS I MENTIONED YESTERDAY, WE
WELCOME THE BSA MEMBERS, ALL BSA
MEMBERS, AND NCAB MEMBERS TO
PARTICIPATE IN DISCUSSION BUT
ONLY BSA MEMBERS WILL BE VOTING.
FIRST IS A NEW RFA/COOPERATIVE
AGREEMENT, ADVANCING CANCER
CONTROL EQUITY RESEARCH THROUGH
TRANSFORMATIVE SOLUTIONS.
DR. APRIL OH WILL PRESENT.
SUBCOMMITTEE CHAIRED BY OTIS
BRAWLEY, SUPPORTED BY KAREN AND
GLORIA.
APRIL, GO AHEAD AND START US OFF
WITH YOUR PRESENTATION
>>ON BEHALF OF MYSELF AND
BRENDA, I'M PLEASED TO PRESENT
THIS CONCEPT.
DESPITE CONSIDERABLE ADVANCES IN
CANCER RESEARCH DISPARITIES
PERSIST.
THIS HIGHLIGHTS DISPARITIES IN
RURAL POPULATIONS.
AFRICAN AMERICAN WOMEN TWO TIMES
MORE LIKELY TO BE DIAGNOSED WITH
AND DIE FROM TRIPLE-NEGATIVE
BREAST CANCER, MULTIPLE MYELOMA
DUE TO LATE STAGE DIAGNOSIS IN
PART.
WOMEN IN RURAL AREAS ARE TWICE
AS LIKELY TO DIE FROM CERVICAL
CANCER.
WITHOUT ADDRESSING THESE DRIVERS
OR ROOT CAUSES THAT CANCER
CONTROL INTERVENTIONS WILL HAVE
MINIMAL IMPACT IN REDUCING
DISPARITIES AND ADVANCING
EQUITY.
AS PART OF EQUITABLE APPROACH TO
ADDRESSING THESE INEQUALITIES,
COMMUNITY PARTNERS ARE ESSENTIAL
FOR ENGAGEMENT AND IMPACT.
NEXT SLIDE.
ADVANCING CANCER CONTROL EQUITY
IS LINKED TO UNDERSTANDING SDOH,
AS ILLUSTRATED SOCIAL
DETERMINANTS HAVE A MULTI-LEVEL
IMPACT ON RISK FACTORS.
WE NEED SCIENTIFIC PROGRESS IN
THE FOLLOWING AREAS TO EXPAND
THE EVIDENCE BASE.
FIRST LACK OF INTERVENTION,
INCLUDING FOCUS ON SDOH TO
ADDRESS STRUCTURAL BARRIERS.
NOR EVIDENCE FOR HOW SOCIAL
DETERMINANTS OF HEALTH
INTERVENTIONS WORK OR MECHANISMS
BY WHICH STRUCTURAL
INTERVENTIONS CAN MAKE AN IMPACT
BEYOND INDIVIDUAL LEVEL TO
MULTI-LEVEL APPROACHES THAT
INCLUDE HEALTH SYSTEM COMMUNITY
BARRIERS AND INSTITUTIONAL
FACTORS THAT IMPACT
INEQUALITIES.
WE NEED TO BETTER UNDERSTAND
INVESTMENT AND EXPAND IN
COMMUNITY ENGAGEMENT
INTERVENTION RESEARCH TO BETTER
ELUCIDATE EFFECTIVE COMMUNITY
ENGAGEMENT STRATEGIES.
AND IN THESE EFFORTS WE NEED TO
EMPHASIZE INTEGRATION OF
CAPACITY BUILDING AMONGST
DIVERSE SCHOLARS, STAKEHOLDERS,
COMMUNITY PARTNERS, AND
INCORPORATE THE LIVED
EXPERIENCES OF THE UNDERSERVED.
NEXT SLIDE.
FOR THIS CONCEPT WE DEFINED
CANCER CONTROL EQUITY AND SOCIAL
DETERMINANTS OF HEALTH ON THE
LEFT.
IN RESPONSE TO THE PREVIOUSLY
IDENTIFIED GAPS, WHAT WE'RE
SEEKING TO DO VIA CENTERS
INITIATIVE IS TO INTEGRATE THESE
FOUR AREAS INTO ONE MODEL TO
ADVANCE CANCER CONTROL EQUITY BY
INTEGRATING FOUR AREAS OF
SCIENCE MOVING BEYOND DOCUMENT
HEALTH DISPARITIES.
WE'RE PRODUCING THROUGH
TRANSFORMATIVE SOLUTIONS, SEEK
FUNDING FOR UP TO FOUR I OF U19
CENTERS, ONE U24 TO ADVANCE
CANCER CONTROL EQUITY RESEARCH
BY USING COMMUNITY ENGAGEMENT TO
DEVELOP INTERVENTIONS THAT
TARGET MULTI-LEVEL PATHWAYS BY
WHICH SOCIAL DETERMINANTS OF
HEALTH IMPACT ADVERSE CANCER
OUTCOMES.
SECOND, DEVELOP MEASURES,
EVALUATE AND ASSESS COMMUNITY
LEVEL SDOH, ENGAGEMENT AND
CANCER CONTROL EQUITY PROCESS
AND OUTCOMES.
THIRD, BUILD COMPASS PI AMONG
DIVERSE SCHOLARS AND COMMUNITY
PARTNERS TO IMPLEMENT
INTERVENTIONS THAT INCORPORATE
THE LIVED EXPERIENCE OF THOSE
WHO MAY FACE CANCER
INEQUALITIES.
NEXT SLIDE.
WE'RE PROPOSING THE FOLLOWING
CENTER STRUCTURE INCLUDING ADMIN
CORE, RESEARCH CORE, METHODS AND
MEASURES AND DATA CORE, CAPACITY
BUILDING CORE.
NEXT SLIDE.
THROUGHOUT THIS STRUCTURE WE'RE
PROMOTING COMMUNITY PARTNER
ENGAGEMENT, FOR EXAMPLE RESEARCH
CORE WILL INCLUDE ENGAGEMENT IN
DEVELOPING INTERVENTION, METHODS
MEASURES AND DATA CORE
ENGAGEMENT OF COMMUNITY AND
IDENTIFYING AND TESTING EQUITY
METRICS AND DATA COLLECTION
ANALYSIS AND DISSEMINATION,
CAPACITY BUILDING CORE WHICH
WE'RE EXCITED ABOUT AN
OPPORTUNITY FOR JUNIOR
INVESTIGATORS OR NEW
INVESTIGATORS TO WORK WITH
COMMUNITY PARTNERS AND
PRACTITIONERS TO CO-CREATE
CAPACITY IN RESEARCH, COMMUNITY
ENGAGEMENT METHODS, LIVED
EXPERIENCE OF COMMUNITY AND
RESEARCH.
EACH CENTER WILL BE DESIGNED
AROUND PROPOSED CANCER CONTROL
HEALTH EQUITY RESEARCH THEME,
INFORMING OVERALL RESEARCH
AGENDA, LEVERAGING THE
INFRASTRUCTURE OF THE CORES,
CENTERS WILL CONDUCT AT LEAST
ONE LARGE SCALE SDOH TRIAL
RELATIVE TO RESEARCH THEME
INTERVENING ON ONE OR MORE SDOH
BUILDING IN FLEXIBILITY AND
RESPONSIVENESS TO FACILITATE
RESEARCH, CENTERS WILL ALSO BE
ABLE TO CONDUCT PILOT STUDIES
WITHIN THE CENTER'S BROADER
RESEARCH THEME TO CONTRIBUTE TO
AND INFORM THE SDOH
INTERVENTION, AN ESSENTIAL
COMPONENT TO APPROACH TO ALLOW
FOR DEVELOPMENTAL PILOT STUDIES
DRIVEN BY COMMUNITY IDENTIFIED
NEEDS, NEED TO TEST FEASIBILITY,
ADOPTION, AND CULTURAL
RELEVANCE.
NEXT SLIDE.
I WOULD LIKE TO DESCRIBE WHAT A
RESPONSIVE INTERVENTION WOULD
LOOK LIKE.
MOVING FROM LEFT TO RIGHT A
RESPONSIVE INTERVENTION WOULD
IDENTIFY AT LEAST ONE SDOH TO
DEVELOP THE MULTI-LEVEL
INTERVENTION AT TWO OR MORE IN
THE MID-OF THE FIGURE, INCLUDING
COMMUNITY AND ORGANIZATIONAL
FACTORS LIKE THE HEALTH SYSTEM,
FAMILIES AND HOUSEHOLDS,
INTERPERSONAL FACTORS,
INDIVIDUALS.
THEN TO THE RIGHT SIDE
ULTIMATELY ADDRESS INEQUALITIES
AND CANCER RISK OR OUTCOMES FOR
EXAMPLE CANCER-RELATED RISK,
HEALTH BEHAVIORS, SCREENING,
QUALITY OF LIFE ARE A FEW
EXAMPLES.
ONE WAY A CENTER COULD RESPOND
IS WORKING WITH COMMUNITY
PARTNERS COULD IDENTIFY FOOD
INSECURITY IS ONE OF THE BIGGEST
FACTORS IMPACTING COMMUNITY'S
ABILITY TO ADDRESS CANCER
PREVENTION THROUGH HEALTHY DIET,
REDUCTION IN OBESITY AND
SUBSEQUENTLY COULD PROPOSE
COMMUNITY LEVEL INTERVENTION AND
OUTCOMES FOR EXAMPLE FARMERS
MARKET, WORKING WITH CONVENIENCE
STORES, REFRIGERATION OF FRESH
FOODS, HOSPITALS ON SCREENING
AND REFERRALS RELATED TO SOCIAL
NEEDS TO REFER HUNGER OF FOOD
BENEFITS, INDIVIDUAL OR FAMILY
LEVEL NUTRITION INTERVENTIONS
CULTURALLY TAILORED INCLUDING
COOKING SKILLS AND EDUCATION TO
REDUCE RISK FOR CANCER ON THE
RIGHT SIDE.
NEXT SLIDE.
WE'RE SEEKING A CORE CENTER TO
ADVANCE SYNTHESIS OF EQUITY
RESEARCH PRODUCTS AND PRACTICES
PRODUCED FROM THE SUM OF THE U
129 CENTERS INCLUDING AND -- U19
CENTERS, WITH CRITICAL
COMPONENTS ESSENTIAL TO ADVANCE
CANCER HEALTH EQUITY RESEARCH
AND WE'VE LISTED A FEW HERE ON
THE SLIDE BUT I'D LIKE TO
HIGHLIGHT A FEW.
HEALTH IMPACTS OF SDOH ON
POPULATIONS CAN DIFFER, ONGOING
NEED FOR SYNTHESIS OF
MEASUREMENT IN HEALTH EQUITY,
AND TARGETING AND TAILORING
CULTURALLY APPROPRIATE
MATERIALS.
WE NEED TO SYNTHESIZE LEARNINGS
ON COMMUNITY ENGAGEMENT
STRATEGIES ACROSS POPULATIONS
AND CONTEXT, AND CENTER WOULD
SUPPORT DATA SHARINGS AND
SYNTHESIS IN WAYS ACCEPTABLE AND
INFORMATIVE TO LOCAL COMMUNITY.
FACILITATE NETWORK-WIDE
ASSESSMENT OF THE IMPACTS OF
PARTNERSHIPS, AND COORDINATE
EXTERNAL COLLABORATION WITH
OTHER RELEVANT RESEARCH
INITIATIVES.
OUR PROPOSE THE BUDGET TO FUND
FOUR U19 CENTERS FOR
$48.5 MILLION OVER FIVE YEARS,
ONE U24 COORDINATING CENTER FOR
TOTAL INVESTMENT OF $4.1 MILLION
OVER FIVE YEARS.
NEXT SLIDE.
SOME EVALUATION CRITERIA ARE
LISTED HERE AND ARE GUIDED BY
END GOAL OF INTERVENTION AND
EVIDENCE BASE TO INFORM
SUSTAINABILITY, ADOPTION,
IMPACT.
OVER THE COURSE OF THE
INITIATIVE WE ANTICIPATE SEEING
IMPACTS OF SDOH INTERVENTION ON
INEQUALITY, REDUCTION OF
DISPARITIES AND INTERVENTION AND
APPROACHES READY FOR SCALEUP.
WE WANT WANT TO THANK THE REVI.
THREE AREAS WERE RAISED FOR
FURTHER CLARIFICATION.
FIRST, ASKED TO CLARIFY
OPPORTUNITIES AND EXPECTATIONS
FOR CROSS-CENTER COLLABORATION.
WE SEE THESE FOUR CENTERS AND
COORDINATING CENTERS AS
OPERATING AS RESEARCH NETWORK.
GUIDANCE PROVIDED TO SPECIFY
COORDINATION BETWEEN THE CENTER
CORES AND COORDINATING CENTER ON
MEASUREMENT, SDOH MECHANISM,
DESIGN OF MULTI-LEVEL
INTERVENTIONS.
WE WANT TO EMPHASIZE
CROSS-COLLABORATION AND LEARNING
ARE ESSENTIAL AND SDOH FOCUSED
INITIATIVE, THE VALUE IS AN
OPPORTUNITY TO LEARN AND DEVELOP
AN EVIDENCE BASE ACROSS DIVERSE
POPULATIONS AND CONTEXT,
MECHANISMS OF SDOH ON CANCER,
ESSENTIALLY SUM TOTALS WILL
CONTRIBUTE.
SECOND, OR EQUITY RELATED
INVESTMENTS, HOW MIGHT THEY BE
CONNECTED?
AS U24 WE WILL PROVIDE GUIDANCE
TO THE COORDINATING CENTER TO
PROVIDE LEADERSHIP AND SUPPORT
TO CONNECT WITH OTHER
EQUITY-RELATED INITIATIVES AT
NCI AND ACROSS NIH.
FOR EXAMPLE ON DELIVERY OF
TRAINING AND CLICK A OF --
CURRICULA OF COOL -- TOOL KITS
WE WILL PROVIDE GUIDANCE ON
OPPORTUNITIES TO USE EXISTING
AND DEVELOPED TRAINING TOOL KITS
WITH SUPPORT FROM COORDINATING
CENTER, LEVERAGED NETWORKS,
PROVIDE GUIDANCE TO CENTERS ON
COMPETITIVE OPPORTUNITIES TO
SUPPORT SCHOLARS AND COMMUNITY
PARTNERS TRAINING EFFORTS
INCLUDING EXISTING MECHANISMS
THAT ARE OFFERED AT NCI.
THANK YOU FOR THE OPPORTUNITY TO
SHARE THE CONCEPT.
WE WELCOME YOUR QUESTIONS AND
COMMENTS.
MY COLLEAGUES ARE ALSO ONLINE TO
ANSWER YOUR QUESTIONS.
>>GREAT.
THANK YOU, APRIL.
OTIS, GET US STARTED.
>>YEAH, FIRST I WANT TO THANK
DR. OH, AJAY, AND DR. BAILEY AND
DR. BERTAGNOLLI, THESE ARE ARE
THREE OF A GROUP OF VERY FINE
PEOPLE THAT YOU NOW LEAD AT THE
NCI.
THIS WAS A GREAT ANSWER TO DR.
WINKFIELD'S CONCERN RAISED
YESTERDAY.
I DON'T WANT TO UPSET PEOPLE
HERE BUT I THINK THERE'S TOO
MUCH EMPHASIS TO MINORITY
INCLUSION IN CLINICAL TRIALS,
NOT ENOUGH EMPHASIS AND GETTING
MINORITIES AND POOR WHITE PEOPLE
FOR THAT MATTER ADEQUATE
TREATMENT.
THIS IS A RESEARCH PROJECT AIMED
AT TRYING TO ELUCIDATE HOW YOU
GET ADEQUATE CARE TO HUMAN
BEINGS.
I WOULD ALSO POINT OUT THAT, YOU
KNOW, THE SOUTHWESTERN GROUP HAS
PUBLISHED WONDERFUL WORK LOOKING
AT THEIR OUTCOMES, FINDING EQUAL
TREATMENT YIELDS EQUAL OUTCOMES
AMONG EQUAL PEOPLE.
EQUAL PEOPLE IS THE KEY HERE.
WHEN YOU FIND BLACK-WHITE
DISPARITIES OR RURAL-URBAN
DISPARITIES IT'S ALMOST ALWAYS
BALLS OF -- BECAUSE OF POVERTY
THAT THEY HAVE THESE
DISPARITIES.
MORE WORK IN THIS AREA NEEDS TO
BE DONE, AND I OFTEN QUOTE THE
FACT IN METROPOLITAN ATLANTA 7%
OF BLACK WOMEN WITH LOCALIZED
NEWLY DIAGNOSED LOCALIZED
CLINICALLY LOCALIZED CURABLE
BREAST CANCER, 7% WILL GET NO
TREATMENT WITHIN THE FIRST YEAR
AFTER DIAGNOSIS.
WE NEED TO FIGURE OUT WAYS --
I'LL REMIND YOU THAT THE
RESEARCH THAT SAYS YOU CUT THE
TUMOR OUT WAS DONE IN 1895.
AND HERE IT IS 2022.
7% ARE NOT GETTING TREATED.
SO DR. OH, DR. AJAY, DR. BAILEY,
THANK YOU VERY MUCH.
YOU WERE INCREDIBLY RESPONSIVE
TO THE RATHER SMALL CONCERNS
THAT WE HAD BECAUSE THIS WAS
VERY WELL WRITTEN TO BEGIN WITH.
I YIELD TO MY COLLEAGUES.
>>THIS IS GLORIA.
I'LL JUST ADD THAT THERE WAS A
LOT OF ENTHUSIASM FOR THIS
CONCEPT IN OUR SUBGROUP.
I THINK IT WAS REALLY THOUGHT
THAT IT WAS CAREFULLY THOUGHT
THROUGH, THE MECHANISM SEEMED
APPROPRIATE.
WE WERE SUPPORTIVE OF THE IDEA
OF HAVING A COORDINATING CENTER
THAT CAN SYNTHESIZE AND CULL THE
FINDINGS ACROSS DIFFERENT
RESEARCH PROJECTS AND SO IN
GENERAL IT WAS JUST A STRONG
SUPPORT FOR THIS APPLICATION.
SO THANK YOU FOR THE
PRESENTATION.
>>I CONCUR.
A WELL-WRITTEN CONCEPT,
APPRECIATE THE WORK THAT WAS PUT
INTO THIS.
THE MAIN CONCERN THAT I RAISED
WAS MAKING SURE THAT THIS
INITIATIVE INTERACTS WITH OTHER
NCI AND NIH INITIATIVES IN THIS
AREA SO THAT WE CAN REALLY LEARN
AS MUCH AS POSSIBLE.
AND THE TEAM HAS NICELY
ADDRESSED THAT.
SO I AM FULLY SUPPORTIVE OF THIS
CONCEPT.
>>THANK YOU, COMMITTEE MEMBERS.
WE HAVE MULTIPLE HANDS THAT SHOT
UP.
WHEN THE NCI DIRECTOR RAISES HIS
OR HER HAND WE SHOOT OVER TO
THAT SQUARE.
>>MONICA?
>>THAT DOESN'T MEAN MY COMMENTS
ARE MORE VALUABLE THAN ANYONE
ELSE'S, BUT I WANT TO THROW IN
THAT THE -- ONE OF THE NICE
THINGS ABOUT THE MOONSHOT WE'RE
ASKED TO CREATE AN ALL OF
GOVERNMENT APPROACH.
WE DO RESEARCH, BUT RESEARCH HAS
TO POINT THE WAY.
THERE WOULD BE NOTHING MORE
GRATIFYING THAN TO SAY TO THE
REST OF HEALTH AND HUMAN
SERVICES, HERE IS THE ROADMAP
FOR THE RIGHT WAY TO DO THIS
NOW, LET'S TALK ABOUT
IMPLEMENTATION ACROSS ALL OF
GOVERNMENT.
I REALLY LOVE THIS KIND OF WORK
BECAUSE WE KNOW WE CAN DO
SOMETHING WITH IT.
>>ANDREA?
>>YES, THANK YOU.
THAT'S AN EXCITING PROPOSAL.
I JUST WONDERED IS THERE AN
EXPECTATION OR REQUIREMENTS FOR
OTHER LANGUAGES BESIDES ENGLISH
IN MANY IMPOVERISHED COMMUNITIES
ARE MADE UP OF LATINO SPEAKING,
OTHER LANGUAGES BESIDE ENGLISH,
IT WOULD BE A SHAME TO MISS OUT
ON ADDRESSING THAT POPULATION.
IS THERE SOME SORT OF
EXPECTATION OR REQUIREMENT TO
INCLUDE MORE THAN ENGLISH IN
THIS PROJECT?
>>OH, WHAT A GREAT POINT.
THANK YOU FOR RAISING THAT.
AND THE OPPORTUNITY TO CLARIFY.
WE SEE THE COORDINATING CENTER
AS IT'S SYNTHESIZING PRODUCTS
ACROSS THE U19s AS THE PLACE
WHERE DEVELOPING THOSE TARGETED
AND TAILORED CULTURALLY
APPROPRIATE MATERIALS WOULD ALSO
INCLUDE LANGUAGE ACCESSIBILITY
SO THANK YOU FOR RAISING THAT.
>>THANK YOU.
>>THANKS, KEITH.
THE CONTENT IS GRATIFYING AND
HEARTWARMING.
MY QUESTION IS MORE MUNDANE,
CLARIFICATION MIGHT BE NEEDED.
THE IMPORTANCE TO DEFINE WHAT
COMMUNITY ENGAGEMENT MEANS
BECAUSE AS YOU KNOW, THIS IS A
TERM THAT IS USED LOOSELY BY
EVERYBODY, MEANS DIFFERENT
THINKS TO DIFFERENT PEOPLE,
DEPENDS WHO YOU SPEAK WITH.
CTSA PROGRAM AS A FAIRLY WELL
OILED DEFINITION THROUGH THE
PRINCIPLES OF COMMUNITY
ENGAGEMENT TO THE BOOK PUBLISHED
ONLINE SUGGEST THIS INITIATIVE
ALIGNS.
MONICA'S POINTS,
ALL-OF-GOVERNMENT APPROACH,
GROUPS WITH WORK IN THIS AREA
CAN HAVE SHARED LANGUAGE IN
TERMS OF WHAT IT MEANS AND ALSO
WHAT IT MEANS TO IMPLEMENT AND
MEASURE THE IMPACT OF THIS
INITIATIVE.
THANK YOU FOR DOING IT.
AND TO ALL OF THE TEAM FOR THIS
WORK.
THIS IS SUCH A WONDERFUL THING
TO SEE.
>>KAREN, ANNA, NELLIE.
>>THANK YOU.
FANTASTIC PROGRAM.
I LOVE SEEING THIS.
IS THIS -- THIS IS A QUESTION
FOR MY OWN CLARIFICATION.
IS YOUR VISION THAT THE CENTER
WILL SORT OF OPERATE MORE IN THE
WAY THAT A LOT OF THE CTSI
CENTERS OPERATE OUT OF THAT
PROGRAM ACROSS THE NIH WHERE
THERE'S A LOT OF INFRASTRUCTURE,
SMALLER MORE LOCALIZED RESEARCH
IN THESE CENTERS, WHICH THEN
COULD POTENTIALLY HAND OFF SOME
AMAZING PROBLEMS AT NCI LIKE OUR
NCTN GROUPS OR NCCOR GROUPS,
DOING A LOT OF THE CARE DELIVERY
WORK ALREADY, ALREADY FOCUSED ON
HEALTH EQUITY, OR ARE YOU SEEING
THIS BE LIKE ITS OWN LARGE
NETWORK WITH BIG CLINICAL TRIALS
THAT RECRUIT FROM ALL THESE
DIFFERENT CENTERS AS WELL?
I'M JUST MAKING SURE I'M ON THE
SAME PAGE WITH WHERE YOU GUYS
ARE.
>>SURE.
THANK YOU, KAREN.
WE SEE THIS AS A RESEARCH
NETWORK OF FOUR U19s AND
COORDINATING CENTER THAT IS
FACILITATING THE
CROSS-COLLABORATION ACROSS THE
U19s ON SPECIFIC SCIENTIFIC
AREAS SUCH AS MEASURES
DEVELOPMENT, AS WELL AS
UNDERSTANDING MULTI-LEVEL
INTERVENTION SCIENCE, NEW
METHODS AND APPROACHES, AS WELL
AS UNDERSTANDING THOSE
MECHANISMS AS THEY CAN OPERATE
DIFFERENTLY BASED ON DIFFERENT
POPULATIONS OR CONTEXTS.
>>GO AHEAD.
>>HI.
REALLY EXCITING.
WHAT I WONDERED, IT IS CANCER
FOCUSED.
WE ARE CANCER FOCUSED BUT IT'S
LIKELY THAT THESE INTERVENTIONS
WILL EXTEND BEYOND CANCER.
AND IT'S LIKELY THAT UNLESS
ENCOURAGED INVESTIGATIVE TEAM
WILL NOT LOOK AT OTHER DATA,
IMPACT ON CARDIOVASCULAR
DISEASE, IT'S GOING TO HAVE
IMPACT ON DIABETES, BONE HEALTH,
MOOD, ET CETERA.
AND SO I'M WONDERING IF THERE
COULD BE SOMETHING IN THERE THAT
WOULD SAY EXPLORATION.
>>THANK YOU FOR THE QUESTION.
IT CAN IMPACT MULTIPLE DISEASE
AND BEHAVIORAL OUTCOMES.
WE CAN PUT CLARIFICATIONS IN THE
CONCEPT.
>>IMPORTANT WORK, I HOPE IT
REACHES MANY INSTITUTIONS.
ONE CHALLENGE WITH THE U SYSTEM,
INS AND OUTS, CENTERS FUNDED AND
THOSE WHO APPLIED AND HAD GREAT
CONCEPTS NOT ABLE TO BE FUNDED,
IN THIS AREA WHETHER WE ALL WANT
TO MAKE PROGRESS IT MAY BE
HELPFUL TO BUILD IN A MECHANISM
OF HOW TO ENGAGE THE BROADER
COMMUNITY, HAVING A MECHANISM TO
HELP THOSE NOT SUCCESSFUL BUT
WANT TO MOVE FORWARD CAN
BENEFIT.
>>GREAT POINT AROUND
DISSEMINATION AND BROADER
ENGAGEMENT BEYOND THE DIRECT
PARTNERS WITHIN THIS INITIATIVE.
THIS IS WHERE COORDINATING
CENTER CAN COME IN AS A U
MECHANISM, WORK DIRECTLY WITH
THEM AROUND SOME OF THOSE
DISSEMINATION ACTIVITIES AND
ENGAGEMENT ACTIVITIES.
THANKS FOR THAT SUGGESTION.
>>OKAY.
KAREN, WOULD YOU MIND TAKING
YOUR HAND DOWN AS WE MOVE TO
VOTING?
OTIS, A MOTION?
>>I MAKE A MOTION.
>>OKAY.
MOTION TO APPROVE.
>>SECOND.
>>THANK YOU.
ANY FURTHER DISCUSSION?
HEARING NONE, MOTION FOR
APPROVAL, I'M LOOKING FOR
DISAPPROVALS.
SORRY I DIDN'T MENTION OUR
PROCESS, TO REMIND YOU, YOU CAN
RAISE YOUR HAND THROUGH THE
WEBEX FUNCTION OR IF THAT'S NOT
WORKING FOR YOU, VOICE YOUR
DISAPPROVAL, OTHERWISE I WILL
ASSUME APPROVAL AS I SCAN BACK
AND FORTH BETWEEN THE SCREENS.
I SEE AND HEAR NUMBER.
I DON'T HAVE ANY PRE-RECORDED
ABSTENTIONS, ANY AT THE LAST
MINUTE?
NO.
PAULETTE?
>>IT'S UNANIMOUS.
>>GREAT.
THANK YOU ALL.
NEXT CONCEPT ALSO A NEW
RFA/COOPERATIVE AGREEMENT
DISCOVERY AND DEVELOPMENT OF
NATURAL PRODUCTS FOR CANCER
INTERCEPTION AND PREVENTION, DR.
MOHAMMED PRESENTING,
SUBCOMMITTEE AS WELL.
JENNY HAD A CONFLICT TODAY AND
COULD NOT BE PRESENT FOR THE
MEETING.
WE WILL REPRESENT HER COMMENTS
WHEN WE GET TO DISCUSSION.
SO ALTAF, GO AHEAD WITH YOUR
PRESENTATION.
>>THANK YOU, DR. FLAHERTY.
A NEW FOA CONCEPT, DISCOVERY AND
DEVELOPMENT OF NATURAL PRODUCTS
FOR PRECISION PREVENTION,
COLLABORATIVE INITIATIVE BY TWO
I.C.s, NCI AND NCATS.
AND THREE DIVISIONS.
WORKING GROUP MEMBERS LISTED
HERE FROM THE DIVISION OF CANCER
PREVENTION.
AS WE KNOW CANCER PREVENTION AND
INTERCEPTION IS THE MOST
PROMISING STRATEGY FOR CANCER
SCROLL, BOTH REDUCING INCIDENCE
AND MORTALITY, SHOWN HERE IS A
SCHEMATIC OF THE ESTABLISHED
TIMELINE OF THE PROGRESSION OF
SELECTED CANCERS AND
PRE-MALIGNANT STAGES, MOST
COMMON EPITHELIAL REPRESENTING
THE FINAL STEP IN A LONG
MULTI-YEAR PROGRESSION FROM
TISSUE INCREASING TO NORMAL
LOOKING STAGES OF TO INVASIVE
CANCER FOR DEVELOPING
STRATEGIES, NEED FOR SAFER
CANCER INTERCEPTION AND
PREVENTION AGENTS IS HIGH, THIS
SHOWS CURRENT STATUS OF THE
RESEARCH AND NEED FOR NEW
DISCOVERY PROGRAM FOR CANCER
INTERCEPTION AND PREVENTION.
CONTINUALLY SEEING GRANTS ON THE
SAME NATURAL AGENTS, LACK OF
TARGETED NATURAL PRODUCTS.
SCENING GRANTS TOO EXPLORATORY
AND COMING TO OTHER CHALLENGES
DISCOVERY RESEARCH FOR
PREVENTION IS INHERENTLY HIGH
RISK AND POTENTIALLY HIGH
REWEAREDDING.
POTENTIAL FOR FLOODING MAGIC
BULLET -- FINDING MAGIC BULLET
IS LOW.
THERE ARE SIGNIFICANT CHALLENGES
TO BE ADDRESSED.
THERE'S A CLEAR OPPORTUNITY TO
EMBRACE THESE RISKS AND
CHALLENGES.
COMING TO THE NEW PROGRAM
JUSTIFICATION, CURRENTLY THERE
ARE NOR NCI PROGRAMS SUPPORTING
THIS TYPE OF RESEARCH
ACTIVITIES, UNIQUE RESOURCES
AVAILABLE FROM THE NCI AND
NCATS, DEFICIENCIES OF
APPROACHES, PROVIDING SAMPLES
QUALITY CONTROLLED AND ALSO
ASSOCIATED WITH SUBSTANTIAL
INFORMATICS.
NO OTHER PROGRAM IN THE
COMMUNITY INCLUDING PHARMA
COMPANIES DOING THE WORK IN THIS
FIELD AND CRITICAL NEED TO
EXPAND DISCOVERY DEVELOPMENT OF
THIS IS CRITICAL FOR CANCER
PREVENTION.
THE OVERALL GOAL OF THIS
INITIATIVE IS TO SUPPORT THE
DISCOVERY AND DEVELOPMENT OF
NATURAL PRODUCTS SAFE,
NON-TOXIC, EFFICACIOUS FOR
CANCER INTERCEPTION
INTERVENTION.
THE UG3 SELECT TARGETS AND
DEVELOP FOR TOXICITY SCREENING.
PURPOSE OF THE UH3 PHASE IS
SCREENING LIBRARIES, STRUCTURE
ELUCIDATION, FULL SCALE
CHARACTERIZATION, EFFICACY
TESTING, DEVELOPMENT OF SCREENED
AGENTS.
SEVERAL HAVE BEEN ESTABLISHED
BUT NCI HAS ONE OF THE LARGEST
COLLECTION OF NATIONAL PRODUCTS,
OVER 500,000 EXTRACTS COLLECTED
FROM PLANT AND SOURCES.
NCI PROGRAM FOR NATURAL PRODUCT
DISCOVERY CANCER MOONSHOT FUNDED
PROGRAM DESIGNED TO STIMULATE
RESEARCH IN NATURAL PRODUCTS IS
PRODUCING ONE MILLION NATURAL
PRODUCT EXTRACTIONS, THE LIBRARY
WITH NEW ARE AVAILABLE TO THE
RESEARCH COMMUNITY AT NO COST.
ON THE OTHER HAND, NCATS WITH
CUTTING EDGE TECHNOLOGIES
COLLABORATES WITH BOTH NIH AND
INVESTIGATORS TO PERFORM COMPLEX
PROGRAMS.
THIS OPPORTUNITY EXISTS TO
INTEGRATE EXPERTISE FOR
DISCOVERY OF NATURAL PRODUCTS
WITH ACTIVITIES USEFUL FOR
CANCER PREVENTION.
FIRST SHOWS FOA PLAN ALONG THE
CONTINUUM, BIPHASIC
MILESTONE-DRIVEN MECHANISM
PROVIDING UP TO THREE YEARS OF
SUPPORT FOR THE STUDIES, TARGET
SELECTION, VERIFICATION IN
PRE-CLINICAL SAMPLES,
DEVELOPMENT AND VALIDATION,
PROTOTYPE HTS AND PILOT
SCREENING.
UP TO TWO YEARS OF ADDITIONAL
SUPPORT MAY BE AWARDED FOR FULL
SCALE HIGH-THROUGHPUT SCREENING
AND ASSESSMENT.
PROMISING INTERVENTION, LACK OF
TOXICITIES ARE IDENTIFIED, THESE
NATURAL AGENTS CAN ENTER NCI
PREVENT PLAN FOR ADVANCED
PRE-CLINICAL DEVELOPMENT
FOLLOWED BY MOVING TO THE
CLINICAL TRIALS THROUGH THE
PROGRAM.
IN THIS SLIDE WE PROVIDE EXAMPLE
OF POTENTIAL MOLECULAR TARGETS
FOR CANCER INTERCEPTION THAT
PLAY KEY ROLES IN TUMORIGENESIS.
SEVERAL APPROACHES CAN BE
CONSIDERED TO OVERCOME
WELL-STUDIED INHIBITORS
ASSOCIATED TOXICITIES WHILE
MAINTAINING EFFICACY.
MPGES-1 IS RESPONSIBLE FOR INOF
CORRECTION, CONSIDER SAFE AND
EFFECTIVE FOR INTERCEPTION AND
TREATMENT.
IT COULD BE USED FOR NATURAL
PRODUCTS SCREENING.
THIS SLIDE SHOWS HIGH LEVEL
PROCESS FOR APPLICATION
SUBMISSION THROUGH FUNDING,
SELECTS TARGET, SUBMISSION
APPLICATION.
STAFF NEGOTIATES MILESTONES,
PROPOSES FUNDING PLAN.
STAFF MONITORS PROGRESS,
PROVIDES ASSISTANCE AS NEEDED.
RECOMMENDS AWARDS.
TO PROVIDE BETTER CLARITY AND
UPON FEEDBACK WE HAVE PROVIDED
THIS.
I HAVE SHOWN ON THIS SLIDE
INVESTIGATORS ARE EXPECTED TO
PROVIDE FOLLOWING
MILESTONE-BASED APPROACHES IN
BOTH PHASES FROM THE TARGET
SELECTION IN THE UG3 PHASE TO
EFFICACY TESTING IN UH3 PHASE.
AS FOR THE CONTRIBUTIONS ON THIS
SLIDE THE PROGRAM WILL ADVISE
APPLICANTS AND PROVIDE
ASSISTANCE BOTH ADVISORY AND
TECHNICAL AT VARIOUS STAGES OF
THE PROJECT DEVELOPMENT AND
IMPLEMENT APPLICATION AS NEEDED.
PORTFOLIO ANALYSIS, USING THE
NIH REPORTER, THERE WERE 88
UNIQUE MULTI-YEAR PROJECTS
IDENTIFIED USING NATURAL
PRODUCTS, CANCER PREVENTION AS
KEY WORDS.
OF THESE 39 PROJECTS,
INVESTIGATOR INITIATED R01 AND
OTHER GRANTS FOCUSING ON
SPECIFIC AGENTS.
SOME PROJECTS ARE THERAPEUTICS.
ONLY ONE PROJECT SPECIFICALLY
APPLIES A SCREENING PLATFORM FOR
THE DISCOVERY OF NOVEL
NON-CYTOTOXIC COMPONENTS FROM
CYANO BACTERIA.
NONE OF THESE PROJECTS FOCUS ON
CLEANING AND DEVELOPMENT OF
NATURAL PRODUCTS FOR CANCER
PREVENTION.
THE TOTAL BUDGET REQUESTED FOR
THIS IS $33 MILLION, LIMITED TO
UP TO THREE YEARS.
ONE RECEIPT DATE PER YEAR, THREE
YEARS SUPPORTING THREE GRANTS
PER YEAR PROVIDING TWO
OPPORTUNITIES FOR THE
SUBMISSIONS, AT LEAST TWO OF
THEM TO THE UH3 FACE.
TOTAL COSTS SET ASIDE FOR
COLLABORATION AND ADDITIONAL
NOVEL RESEARCH AREAS, SUPPORTED
THE MOST PROMISING PROJECTS.
ADDITIONAL RESOURCES WILL ENABLE
SPECIALIZED STUDIES IN NATURAL
CHEMISTRY AND SCALEUP FOR
EFFICACY STUDIES, SUPPORT NCATS
THROUGHPUT SCREENING, AND
RESEARCH EFFORTS TO COMPLEMENT
THE PROJECTS.
WE GO BACK TO LEADERSHIP TO
REQUEST ADDITIONAL FUNDS.
JUSTIFICATION FOR THE RFA AND
MECHANISM, SINCE THERE'S NO NIH
ANNOUNCEMENT FOR THE MECHANISM,
RFA WILL AVAILABLE SOLICITATION
OF HIGH RISK AND HIGH IMPACT,
RFA MECHANISM WILL ALLOW FOR
(INDISCERNIBLE), WITH
SUBSTANTIAL PROGRAMMATIC
INVOLVEMENT BY NCI AND NCATS IT
WILL REQUIRE COOPERATIVE
AGREEMENT.
BOTH STAFF WILL NEGOTIATE AND
MONITOR ROBUST MILESTONES FOR
COOPERATIVE AGREEMENTS, SUBJECT
MODIFICATIONS TO MEET THOSE
MILESTONES.
EVALUATE SCIENTIFIC PROGRAM FOR
TRANSITION.
SUPPORT COMMUNICATION AND
COLLABORATION BETWEEN THESE
PROGRAMS AND OTHER PROGRAMS.
WE THANK THE BSA MEMBERS FOR
MEETING WITH US AND PROVIDING
ADDITIONS.
THE SELECTED ONES WILL GO INTO
THE FOA LANGUAGE LISTED ON THE
NEXT TWO SLIDES.
NCI LIBRARIES WILL BE AVAILABLE.
STAFF WILL WORK WITH SUBMISSION
IN THE UG3 AND UH3 PHASES, AND
THE PROPOSAL DESCRIBED IN THE
FOA, ALSO A FEW WERE LISTED ON
SLIDE 11.
IMPORTANTLY THE BRANCH WILL
PROVIDE DIRECT SUPPORT FOR
ISOLATION, IDENTIFICATION,
STRUCTURAL CHARACTERIZATION OF
BIOACTIVE FRACTIONS/ACTIVE
NATURAL PRODUCTS THROUGHOUT THE
PURIFICATION PROCESS, SET-ASIDE
BUDGET ALLOCATED FOR THESE
ACTIVITIES.
AND THE BUDGET SLIDE WAS TO
PROVIDE BASED UPON THE
SUBCOMMITTEE SUGGESTIONS.
WITH THIS I WILL STOP HERE AND
BE HAPPY TO TAKE QUESTIONS ALONG
WITH WORKING GROUP MEMBERS ON
THIS CALL.
THANK YOU.
>>GET US GOING.
>>THANK YOU, KEITH.
MYSELF, KEITH AND JENNIFER, THE
SUBCOMMITTEE WORKING ON THIS, WE
WERE EXCITED ABOUT THE CONCEPT.
WE MET, DISCUSSED THE CONCEPT,
CAME UP WITH SOME QUESTIONS THAT
WE HAD FOR DR. MOHAMMED,
SCHUMAKER AND CASTLE.
WE MET TO DISCUSS THIS
AFTERWARDS, AND THEY HAVE DONE A
GREAT JOB IN ADDRESSING THE
CONCERNS AND COMMENTS THAT WE
HAD IN THE PRESENTATION IT WAS
CLEAR THEY TOOK THESE TO HEART
AND CLEARLY ADDRESSED ALL THE
MAJOR ISSUES WE HAD.
SOME KEY ISSUES IN TERMS OF
AVAILABILITY OF AMAZING RESOURCE
OF 500,000+ COMPOUNDS, THE ROLE
OF NCI AND TYPE OF SERVICES THAT
WOULD BE AVAILABLE,
INTERDIGITATING WITH OTHER
PROGRAMS, AS WELL AS CLEAR
BOUNDARIES HOW THEY WOULD BE
WORKING IN TERMS OF TRANSITION
FROM THE UG3 TO THE UH3 PART OF
THE PROGRAM.
THEY HAVE DONE A GREAT JOB
ADDRESSING THIS, AND I THINK WE
DISCUSSED IT, QUITE HAPPY WITH
RESPONSES.
KEITH?
>>THANKS, YOU HIT THE
HIGHLIGHTS.
I OTHER POINT, THAT WE
DELIBERATED ON, THIS MECHANISM
AS A WAY TO FILL WHAT WE THOUGHT
WAS A VERY CLEAR UNMET NEED, IN
TERMS OF APPLYING THIS APPROACH,
AND THE PLATFORM TECHNOLOGIES TO
PREVENTION RESEARCH AND ALTHOUGH
IT'S TYPICALLY NOT OUR PURVIEW
TO ADJUST MECHANISMS OR, YOU
KNOW, SUGGEST DIFFERENT, WE DID
FEEL THIS WAS A GOOD FIT ALL
THINGS CONSIDERED IN TERMS OF
WHAT'S NEEDED PARTICULARLY WHAT
ERLE JUST EMPHASIZED, UNIQUE
OFFERING OF NCI RESOURCES BEYOND
JUST COMPOUND LIBRARY BUT
EXPERTISE, NOT JUST FOR
CONSULTATION BUT ACTUALLY
COLLABORATION AND ESSENTIALLY
IN-KIND SERVICES, REALLY THINK
GOING TO VERY MUCH LEVERAGE THE
INVESTMENT THAT IS ALLOCATED TO
EXTRAMURAL INVESTIGATORS.
I THINK AGAIN THIS IS UNIQUE
UNMET NEED, UNIQUE OPPORTUNITY,
UNIQUE RESOURCE AT NCI.
WE CAME AWAY FEELING THESE ARE
NOTFULLY BROUGHT TOGETHER --
THOUGHTFULLY BROUGHT TOGETHER,
AMOUNT OF SUPPORT WHICH ANYONE
COULD SAY MAYBE THIS IS NOT
ENOUGH TO MOVE ANY GIVEN PROJECT
FORWARD BUT THE POINT WE
DELIBERATED ON WITH ALTOF AND
TEAM IS THERE'S SO MUCH BEING
CORRECTED BY NCI THE COST, THE
INTRAMURAL COMMUNITY WILL NEED
IN TERMS OF THEIR COMPONENT OF
THE WORK, I THINK FITS WELL
WITHIN THE SCOPE OF WHAT'S BEEN
DESCRIBED.
WE FELT COMFORTABLE, IN THE END,
THAT THAT WAS THE CASE.
JENNY IS UNABLE TO PARTICIPATE
IN TODAY'S MEETING SO WE'LL MOVE
TO OTHER BOARD MEMBERS.
I SEE ANDY.
>>THIS IS EXCITING.
THERE IS REALLY A HEART FOR NEW
RESEARCH TO HAPPEN WITH NATURAL
PRODUCTS BECAUSE, YOU KNOW, THE
DEMAND FOR THOSE TRADITIONAL R01
STUDY SECTIONS ARE SUCH YOU HAVE
TO BE VERY, VERY DEEP INTO A FEW
AGENTS TO GET ANY TRACTION.
BUT ONE, SEEMS LIKE THIS PROGRAM
WOULD BE REWARDING, FOR
INVESTIGATORS AND GROUPS THAT
HAVE A PRE-DEFINED MOLECULAR
TARGET IN MIND, LIKE REALLY FEEL
IT'S GOING TO BE THE KEY TARGET,
BUT A LOT OF THESE NATURAL
PRODUCTS WITH NOT GOING TO HAVE
SINGLE MOLECULAR TARGETS,
OFFER-TARGET EFFECTS BUT STILL
POTENTIALLY PREVENTIVE FOR
CANCER, SUCCESSFUL PREVENTION
AGENTS.
WHAT'S THE THOUGHT ABOUT
ADDRESSING THAT KIND OF
POTENTIAL PROPOSAL?
HOW CAN WE ALSO ENSURE THAT THE
RIGHT KINDS OF NATURAL PRODUCTS
GET PUSHED FORWARD THAT MIGHT
HAVE LESS CLEAR MOLECULAR
MECHANISM BUT STILL MIGHT BE
EFFECTIVE AGENTS?
>>YEAH, YOU STATED CORRECTLY,
THEY DON'T HAVE A SINGLE TARGET,
THE IDEA IS TO SELECT A
CLINICALLY RELEVANT VALID TARGET
FOR INTERVENTION AND SCREEN THE
AGENTS FOR THE TARGET.
AND SCREENING AGENTS MAY HAVE
OTHER EFFECTS BUT WE'LL NOT KNOW
UNTIL WE GO AND EVALUATE THEM
WITH OTHER ASSAYS, SO BUT WILL
ASK FOR THE P.I.s TO COME WITH
CLINICALLY DEVELOPED TARGETS BUT
THOSE AGENTS HAVE OTHER EFFECTS
TOO, YEAH.
>>INTERESTING PROPOSAL, MY
QUESTION IS IT STRIKES ME A LOT
MUST BE INVESTED IN MAINTAINING
THIS LIBRARY, WE'RE GOING TO
INVEST MORE.
WHAT'S THE TRACK RECORD THAT
INDICATES THERE ARE ACTUALLY
VIABLE COMPOUNDS IN THIS LIBRARY
THAT CAN TURN INTO WHAT IS BEING
SOUGHT HERE?
AND WHY IS THIS SPECIFIC FOCUS,
WHY IS THERE SOMETHING SPECIAL
ABOUT NATURAL PRODUCTS THAT ARE
BEING CONSIDERED FOR
INTERCEPTION?
>>CAN I JUMP IN AND THEN I'LL
TURN IT OVER TO BARRY TO TALK
ABOUT SUCCESSES.
THIS IS ONE PLACE TO START,
CERTAINLY OTHER CHEMICAL
LIBRARIES COULD BE CONSIDERED
GOING DOWN.
WE'VE NEVER DONE THIS BEFORE.
I WANTED TO TAKE ADVANTAGE OF
RELATIONSHIPS WITH NCATS,
DEVELOPMENT OF NATURAL PRODUCTS,
THIS COULD BE CONSIDERED FOR
OTHER MOLECULAR ENTITIES, ALSO
COULD BE CONSIDERED FOR OTHER
APPLICATIONS.
I DON'T WANT TO SAY TOO MUCH,
BUT I'VE BEEN THINKING ABOUT
THIS IN A COUPLE OTHER SPACES.
BARRY CAN SPEAK ABOUT SPECIFIC
SUCCESSS OF THE PROGRAM.
HE PRESENTED THIS I WANT TO SAY
A YEAR AGO, MAYBE IT WAS A YEAR
AGO ABOUT WHAT THEY'VE DONE SO
FAR IN TERMS OF THE -- YOU KNOW,
THEY HAVE WORKED ON TREATMENT
AND THAT SPACE.
BARRY, MAYBE YOU COULD JUMP IN
AND TALK ABOUT THINGS THAT
HAPPENED OF HAVE BEEN SUCCESSFUL
FROM THIS LIBRARY.
>>SURE.
HAPPY TO.
SO THE LAST TIME WHEN I WAS ABLE
TO PRESENT THIS TOO THE NCAB WE
WEREN'T ABLE TO TELL SOME THINGS
BECAUSE IT WAS PUBLIC
DISSEMINATION OF THEM.
I CAN GIVE SOME RECENT THINGS,
FOR EXAMPLE, ANTI-CANCER AGENT
THAT WE'VE WORKED WITH, BAYLOR
UNIVERSITY, TEXAS CHILDREN'S,
FOUND A NEW NATURAL PRODUCT WE
WERE ABLE TO RESUPPLY IN
QUANTITY SHRINKING TUMORS IN
THEIR HANDS, ISOLATELY RECENTLY
THAT HAS GONE TO CLINIC
ANTI-SARS-COV-2 AGENTS THAT HAVE
BEEN SUCCESSFUL IN PHASE 1,
INITIAL STUDIES THERE.
THOSE ARE BIOLOGICS, SMALL
PROTEINS AND PEPTIDES.
ALSO RECENT DISCOVERIES OF NOVEL
KINASE INHIBITORS ASSOCIATED FOR
YOURS WITH FOHCC, IN DEVELOPMENT
IN THE CCR AS WELL, AGAIN A
NOVEL NATURAL PRODUCT.
OVERALL WE'RE SEEING AND WE'RE
COLLABORATING WITH A LOT OF
LABORATORIES IN THE THEY ARE --
THERAPEUTIC AREA, THEY MIGHT
HAVE BEEN SCREENED IN CY TOE
TOXICITY SCREENS, 80% THAT WE'RE
IDENTIFYING AS ACTIVE ARE NOT
ACTIVE WHEN CRUDE EXTRACT WAS
TESTED, A LOT OF CHEMISTRY WAS
EARLIER MISSED IN ASSAYS.
MOSTLY LOOKING AT CYTOTOXICITY,
TRYING TO GET INTO MODALITIES
NOT JUST KILLING CELLS BUT
LOOKING AT BROADER MODALITIES
WITH DIFFERENT TARGETS.
WE THINK CHEMICAL DIVERSITY
PRESENT IN THIS LIBRARY WILL
ENABLE US TO SEE TARGETS
ADDRESSED HERE IN
CHEMOPREVENTION THAT WOULD HAVE
BEEN MISSED OTHERWISE OR HAVEN'T
BEEN LOOKED AT TO BE HONEST.
>>MIKE AND DAVE?
>>WHO GOES FIRST?
>>MIKE.
>>THIS WAS INTERESTING BECAUSE
I DO THINK THE DRUM BEAT OF
USING NATURAL PRODUCTS IS UPON
US.
CAN'T BE IGNORED.
KUDOS ON THIS WORK.
THE QUESTION, THERE IS AN NIH
CENTER AND INSTITUTE THAT'S
LEADING THE WAY WITH THE SCIENCE
IN THIS AREA, AND CONNECTIVITY.
I WONDER WHAT NCI'S PLANS ARE TO
COLLABORATE INTERAGENCY IN THIS
AREA?
>>I GUESS I CAN SPEAK TO THAT A
LITTLE BIT SINCE WE'RE KIND OF
AT THE NEXUS OF THAT.
WE ALREADY HAVE INTERAGENCY
AGREEMENT WAS NIAID, NCCIH,
NCATS ON A NUMBER OF DIFFERENT
MODALITIES FOR A NUMBER OF
HEALTH-RELATED SCREENING AND
COMPOUND IDENTIFICATION.
WE ARE MAKING DATA.
WE WILL BE PART OF THE NATURAL
PRODUCT OPEN DATABASE OF NMR
STRUCTURAL DATA THAT IS BEING
FUNDED BY NCCIH TO ENABLE
RESEARCHERS AROUND THE WORLD TO
HAVE ACCESS TO ALL THE DATA ON
THE COMPOUND STRUCTURES AND NMR
DATA FOR THAT AS WELL.
SO WE HAVE COLLABORATED WITH A
NUMBER OF DIFFERENT GOVERNMENT
AGENCIES, INCLUDING DoD, ON
THIS ALREADY AND HAPPY TO DO SO.
WE'VE WORKED OUT FACILE
MECHANISMS TO ENABLE US TO DO
EXACTLY THAT.
>>THANK YOU.
>>I APPRECIATE THE PRESENTATION
AND TOPIC.
SOME OF THE MEMBERS HAVE SAID,
MOST NATURAL PRODUCTS ARE POLY
PHARMACEUTICALS, AND THIS IS
WHAT'S MADE IT EXTREMELY
CHALLENGING TO MAKE A LOT OF
PROGRESS RAPIDLY.
I THINK SOME POINTS BARRY
BROUGHT UP ABOUT ACTUALLY HAVING
PURIFIED COMPONENTS FROM
EXTRACTS WERE TERRIFIC BUT IT
COMES BACK TO STILL A VERY LARGE
MOLECULE WITH MULTIPLE CENTERS
AND A MESSY EXPERIMENT.
THE SCREENING, PHENOTYPIC
SCREENINGS, THEY ARE AMAZING,
GREAT, BETTER THAN KILLING
CELLS, STOPPING CELL
PROLIFERATION.
ONE STEP FURTHER, THE NOBEL
PRIZE WAS GIVEN TEN HOURS AGO
FOR CLICK CHEMISTRY, HOW YOU
TAKE NATURAL PRODUCTS TO THAT
NEXT LEVEL WHERE YOU CAN
ACTUALLY FIGURE OUT EXACTLY WHAT
PROTEINS YOUR MOLECULES ARE
INTERACTING WITH AND DO
ITERATIVE CHEMISTRY TO FIND A
GOOD MOLECULE THAT SOMEONE'S
GOING TO PUT IN A PATIENT.
I DIDN'T HEAR ANYTHING ABOUT NEW
CHEMISTRY THAT YOU COULD APPLY
TO YOUR REALLY GREAT BESPOKE
COLLECTION, I WOULD ENCOURAGE
YOU TO PUT THAT LANGUAGE IN AND
YOU HAVE PEOPLE AT THE NCI, FRED
RICK, THE RAS PROGRAM, GET IT TO
THE NEXT LEVEL WHERE YOU MIGHT
HAVE A BIGGER IMPACT.
>>THANK YOU.
LET'S MOVE TO VOTING.
MAKING SURE THERE'S NO RESIDUAL
HANDS UP.
>>I'D LIKE TO MOTION TO MOVE
THE CONCEPT FORWARD.
>>ANY FURTHER DISCUSSION?
HEARING NONE, MOTION IS TO
APPROVE
, LOOKING FOR DISAPPROVAL BY
RAISE OF HAND OR VOICE.
SEEING AND HEARING NONE, I HAVE
NO ABSTENTIONS ON RECORD.
AND ANYONE NEEDS TO ABSTAIN NOW
PLEASE SAY SO.
NO.
OKAY, PAULETTE.
>>YOU'RE GOOD.
>>THE THIRD CONCEPT IS A
REISSUANCE RFA/COOPERATIVE
AGREEMENT, BLOOD AND MARROW
TRANSPLANT CLINICAL TRIALS
NETWORK, BMT CTN, LORI HENDERSON
PRESENTING.
THE SUBCOMMITTEE REVIEWED THIS
PROPOSAL AND DISCUSSED WITH THE
TEAM.
AS WE DO FOR ALL REISSUANCES,
DISCLOSE THAT GOING INTO THE
PRESENTATION AND DISCUSSION THAT
THE SUBCOMMITTEE'S
RECOMMENDATION IS FOR
CONCURRENCE AND PRESENTATION OF
THE PROPOSAL TO REISSUE.
SO LET'S GO AHEAD, LORI, WITH
YOUR PRESENTATION.
>>THANK YOU.
THE PURPOSE OF MY PRESENTATION
TO REQUEST FUNDS TO SUPPORT
CONTINUE WAILINGS OF THE BLOOD
AND MARROW TRANSPLANT CLINICAL
TRIALS NETWORK, THIS WOULD BE
FOR ANOTHER SEVEN YEARS.
BMT CTN WAS ESTABLISHED BY
NATIONAL HEART LUNG AND BLOOD
INSTITUTE, AND NCI, BACK IN
2001.
AND CURRENTLY FUNDED THROUGH
COOPERATIVE AGREEMENT, TWO
RFAs, ONE FOR DATA
COORDINATING CENTER, AND THE
OTHER TO SUPPORT CORE CLINICAL
CENTERS.
SINCE TIME IS LIMITED, I'LL JUST
BRIEFLY INTRODUCE THE BMT CTN,
DESCRIBE ACCOMPLISHING,
HIGHLIGHT RESEARCH AREAS THAT
REQUIRE REISSUANCE OF THE TWO
RFAs.
NEXT SLIDE PLEASE.
THE BMT CTN EMERGED AS NATIONAL
LEADER IN DESIGNING AND
SUCCESSFULLY CONDUCTING
TRANSPLANT TRIALS.
THIS IS DUE LARGELY TO
STRUCTURAL, HOW IT ACTUALLY
FUNCTIONS, AND THE CONTRIBUTIONS
TO THE FIELD THAT HAVE BEEN
MADE.
ITS GOAL IS TO CONDUCT PHASE 2
AND 3 TRIALS, THIS IS TO IMPROVE
OUTCOMES IN CELLULAR THERAPIES,
SUCH AS HEMATOPOIETIC STEM CELL
TRANSPLANTATION, WHICH I'LL
REFER TO AS HCT THROUGHOUT MY
TALK, CELLULAR VACCINES, CAR T
CELL THERAPIES TO TREAT PATIENTS
THAT ARE FACING LIFE-THREATENING
BLOOD DISORDERS.
MANY TRIALS IN PORTFOLIO ADDRESS
CHALLENGES IN THE TREATMENT AND
MANAGEMENT OF HEMATOLOGIC
MALIGNANCIES THAT CAN'T BE
REPLICATED ELSEWHERE.
THE TEAM CONSISTS OF WORLD
LEADERS THAT HAVE EVOLVED TO
MEET CURRENT MEDICAL RESEARCH
NEEDS AND HAVE THE EXPERTISE TO
IMPLEMENT CAR T CELL THERAPIES.
THE NETWORK HAS BECOME THE ONLY
U.S. GROUP FOCUSING EXCLUSIVELY
ON ALLOGENEIC HCT.
THE CENTER MEMBERSHIP AND ACTIVE
PARTICIPATION IN TRIALS IS
AVAILABLE TO ALL U.S. CENTERS
THAT HAVE A FACT ACCREDITATION
STATUS.
THIS FEATURE ALLOWS SMALL
MEDICAL CENTERS AND CONSORTIA,
SMALL CONSORTIA TO PARTICIPATE
AND HELP UNDERREPRESENTED
COMMUNITIES GAIN AS SAYS TO
TRANSPLANT TRIALS, 75 AFFILIATE
MEMBERS INCLUDE SEVERAL
NON-ACADEMIC SITES.
IT CONVENES IN OPEN FORUM,
REFERRED TO AS STATE OF THE
SCIENCE SYMPOSIUM, ABOUT EVERY
FOUR YEARS TO SEEK INPUT ON THE
CLINICAL NEEDS, DEVELOP HCT
CONCEPT, AND ESTABLISH
PRIORITIES IN ORDER TO HAVE A
HIGH MERITORIOUS RESEARCH
AGENDA.
AND UPON COMPLETION OF THE
STUDIES THE RESULTS ARE USED TO
INFORM FUTURE TRIAL DESIGNS,
CLINICAL PRACTICE, AND CMS
COVERAGE WHICH BY CONDUCTING
EVIDENCE DEVELOPMENT TRIALS IN
CANCER.
LAST BUT NOT LEAST BMT CTN
PARTICIPATE OR ENDORSES TRIALS
AFFILIATED WITH OTHER NIH-FUNDED
PROGRAMS SUCH AS NCI NATIONAL
CLINICAL TRIALS NETWORK, AIDS
MALIGNANCY CONSORTIUM, AND NIH
SICKLE CELL ZEALS NETWORK,
SUPPORTING ITS OWN MISSION.
SEVERAL PHARMACEUTICAL COMPANIES
PROVIDE SUBSTANTIAL FINANCIAL
SUPPORT TO EVALUATE PROMISING
CELL THERAPIES AND DRUGS IN
TRIALS.
NEXT SLIDE PLEASE.
THE PROGRAM IS CURRENTLY FUNDED
TO PROMOTE THE COMPARISON OF
TREATMENT APPROACHES IN
MANAGEMENT STRATEGIES FOR ADULTS
AND CHILDREN UNDERGOING
TRANSPLANT, EITHER ALONE OR IN
COMBINATION WITH NOVEL
CELL-BASED THERAPIES, AREAS OF
HIGH PRIORITY TO NCI ARE STUDIES
TARGETING LEUKEMIA, MILD
DYSPLASIA, HIV ASSOCIATED
CANCERS.
IT HAS ADDRESSED KEY ISSUES IN
DONOR AVAILABILITY, MAINTENANCE
THERAPY FOR DISEASE CONTROL,
ORGAN AND REGIMEN-RELATED
TOXICITIES, AND QUALITY OF LIFE
STUDIES.
THIS HAS BEEN DONE THROUGH THE
IMPLEMENTATION OF 60 TRIALS OF
WHICH 52 ARE RELEVANT TO NCI'S
MISSION.
AND THE NETWORK HAS BEEN VERY
PRODUCTIVE IN ACTIVATING AND
COMPLETING TRIALS, 35 COMPLETED,
WITH 22 ONGOING.
AMONG THE MOST NOTABLE
ACHIEVEMENTS FROM THE RECENT
PROJECT PERIOD ARE THE 7500
PATIENTS ACCRUED WITH SEVERAL
STUDIES AHEAD OF SCHEDULE,
CONTRIBUTIONS TO THE NCTN
TRIALS, TRIAL RESULTS THAT ARE
DEFINING CLINICAL PRACTICES, AND
POTENTIAL IMPACT OF PUBLICATIONS
IN THE FIELD.
NETWORK PUBLISHED 148 PAPERS
WITH RESULTS FROM 42 TRIALS
DISSEMINATED TO DATE, INCLUDING
29 PUBLICATIONS RESULTING FROM
THE SAMPLE REPOSITORY.
NEXT SLIDE PLEASE.
AMONG THE MOST NOTABLE PUBLIC
HEALTH CONTRIBUTIONS TRIAL
RESULTS THAT DEFINE CLINICAL
PRACTICE, LED TO PARADIGM SHIFTS
IN THE MANAGEMENT OF MULTIPLE
MYELOMA.
MORE THAN 12,000 DEATHS ARE
EXPECTED TO OCCUR FROM AMONG THE
31,000 AMERICANS THAT ARE
DIAGNOSED WITH MYELOMA EACH YEAR
DESPITE TREATMENT ADVANCES OVER
THE YEARS.
THIS MULTIPLE MYELOMA STUDY, THE
BMT CTN CONDUCTED PHASE 3
RANDOMIZED TRIAL COMPARING
SINGLE AUTOLOGOUS TRANSPLANT
WITH AND WITHOUT CONSOLIDATION
THERAPY TO TANDEM TRANSPLANT.
THE RESULTS SHOW NO SIGNIFICANT
DIFFERENCES IN THE THREE-YEAR
PROGRESSION-FREE SURVIVAL AMONG
THE THREE ARMS, AND SO THE STUDY
ACTUALLY PROVIDED EVIDENCE THAT
THE CURRENT STATE OF CARE, THAT
IS SINGLE AUTOLOGOUS TRANSPLANT
WITH MAINTENANCE IS STILL THE
BEST OPTION FOR TREATING THESE
PATIENTS.
AND MORE IMPORTANTLY, LED TO
SUBSTANTIAL DECREASE IN NUMBER
OF UNNECESSARY INTERVENTIONS
BEING PERFORMED SINCE THE
PUBLICATION OF THE RESULTS.
NEXT SLIDE PLEASE.
IN THE SECOND MULTIPLE MYELOMA
EXAMPLE, THE BMT CTN JOINED
DANA-FARBER TO DETERMINE IF HIGH
DOSE THERAPY IS STILL NECESSARY
IN THE INITIAL MANAGEMENT GIVEN
THE FACT THERE ARE NEW NOVEL
IMMUNOMODULATORY BASED THERAPIES
THAT EXIST TODAY.
THIS PHASE 3 STUDY WAS DESIGNED
TO EVALUATE THE CLINICAL BENEFIT
FROM TRIPLET DRUG THERAPY
WITHOUT METE IMMEDIATE HIGH DOSE
THERAPY TO THE RVD PLUS HIGH
DOSE THERAPY AUTOLOGOUS HCT.
RANDOMIZED TRIAL EXAMINES
EFFICACY AND SAFETY OF THE FIRST
LINE TREATMENT, AND PRIMARY
ENDPOINT WAS PROGRESSION FREE
SURVIVAL.
I'M TRYING TO DETERMINE WHY THE
NEXT SLIDE -- OKAY.
OKAY.
SO, THE OUTCOME OF THE -- WE'VE
ADVANCED TO THE RESEARCH AGENDA
FOR REISSUANCE.
THE EXTERNAL EVALUATION OF
PROGRAM WAS ALSO SOUGHT TO
ACCEPT THE PROGRESS AND NEW
TRIALS BEING PERFORMED, THE
AGENDA IS DEFINED BY THE STATE
OF THE SCIENCE SYMPOSIUM.
YOU CAN SEE SOME RESEARCH TOPICS
BEING PROPOSED.
STRATEGIES AND TRIALS REPORTED
AS RELEVANT AND SIGNIFICANT
PROGRESS, SO THE PLAN IS TO LOOK
AT THE RECENTLY COMPLETED PHASE
3 TRIALS IN HIGH PRIORITY AREAS,
FOCUSING ON THESE TOPICS, THREE
NEW STUDIES, TO SUPPORT THREE
IMPORTANT NCTN COLLABORATIVE
STUDIES FOCUSING ON DIFFUSE
LARGE B CELL LYMPHOMA FOR GRADE
3 FOLLICULAR LYMPHOMA, AND
CLASSICAL HODGKIN'S LYMPHOMA.
THE NIH PROGRAM DIRECTOR WILL
CONTINUE TO PARTICIPATE IN THE
PROGRAM PROTOCOL TEAMS, SERVE AS
VOTING MEMBERS ON STEERING
EXECUTIVE COMMITTEE AND ENSURE
OVERALL MANAGEMENT TO ALLOW
PUBLIC/PRIVATE PARTNERSHIPS TO
DEVELOP WITH OUTSIDE FUNDS.
NEXT SLIDE PLEASE.
SO THE NCI BUDGET REQUEST IS TO
SUPPORT THE RENEWAL OF
$3.9 MILLION.
THE TOTAL SEVEN-YEAR COST WOULD
BE 27.3 MILLION, $5.38 MILLION
HAS BEEN APPROVED, TOTALING $81
MILLION, TO SUPPORT 19 AWARDS
INSTEAD OF 21 IN THE CURRENT
PROJECT PERIOD, 18 CLINICAL CORE
CENTERS.
NEXT SLIDE PLEASE.
THANK YOU FOR YOUR ATTENTION.
I'M HAPPY TO ANSWER QUESTIONS
AND APOLOGIZE FOR THE DISCONNECT
BETWEEN THE SLIDES.
>>DO YOU WANT ME TO JUMP IN?
>>GO AHEAD.
>>YEAH, SO I WITH DR. LA LOW
AND DR. ROBERTSON WERE ASKED TWO
QUESTIONS, ONE WOULD WE CONCUR
WITH THE REVIEW THAT HAD BEEN
TAKING PLACE BY A PANEL OF
EXPERTS, ANSWER WAS YES, SHOULD
IT BE PRESENTED HERE, AND WE
FELT IT WAS A VALUABLE REVIEW
FOR THIS GROUP TO HEAR ABOUT
THIS REALLY VALUABLE PROGRAM.
LET ME TELL YOU WE GOT TO LOOK
AT A SUMMARY OF THE ACTIVITIES
OF THE PROGRAM OVER THE LAST
PERIOD BUT ALSO REVIEW WHICH WAS
DONE BY A PANEL OF CONTENT
EXPERTS FROM CTEP WHO
UNANIMOUSLY RECOMMENDED THIS
CONTINUE, BASED ON THE SCIENCE
OF TRANSPLANTATION, PRACTICE
STANDARDS, AND IMPROVEMENTS IN
CLINICAL MANAGEMENT.
YOU HEARD ABOUT SOME OF THE
TRIALS THIS SUPPORTS, THIS
SUPPORTS IMPORTANT TRIALS THAT
CAN'T BE DONE IN ANY OTHER
MECHANISM AND I WANT TO GIVE YOU
A FLAVOR FOR THE REVIEW THAT
THEY RECEIVED BECAUSE I THINK WE
ALL WISH WE COULD GET REVIEWS
LIKE THIS.
PRODUCTIVITY, OUTSTANDING TO
EXCEPTIONAL.
THAT'S OVER THE COVID PERIOD OF
TIME, POINTING OUT THIS PROGRAM
OVER ITS ENTIRE LONGEVITY IS
EXCEPTIONAL.
IT GOT EXEMPLAR I'VE NEVER
HEARD, I'VE HEARD OUTSTANDING
AND EXCEPTIONAL, IT GOT STELLAR
AS A QUALIFIER FOR SELECTION AND
DEVELOPMENT OF CLINICAL TRIALS.
EXCEPTIONAL FOR OVERALL
STRUCTURE.
WE MET TO TALK ABOUT IT, WITH
DR. HENDERSON, A FEW PIECES OF
HOW THINGS HAPPENED WE THOUGHT
WE WOULD LIKE TO HEAR ABOUT, ALL
COVERED IN THE FIRST PART OF THE
PRESENTATION ASKING ABOUT HOW
MEMBERSHIP IS DECIDED, WHO GETS
TO BE INVOLVED, HOW THIS PROGRAM
REACHES UNDERSERVED POPULATIONS,
WANTED TO HEAR MORE HOW STATE OF
SCIENCE LEADS TO THE TRIALS, HOW
MUCH THAT HAPPENS AT THE HIP.
AND ALSO HOW FOUNDING
PARTNERSHIP WITH NHLBI IS.
THAT WAS COVERED, SO I CAN SPEAK
FOR THE COMMITTEE THAT WE DIDN'T
HAVE ANY CONCERNS AND WERE
IMPRESSED WITH THIS IMPORTANT
AND THOUGHT IT WAS IMPORTANT
EVERYONE KNOWS ABOUT IT.
>>THANK YOU.
ANYTHING TO ADD?
>>KIM DID A TERRIFIC JOB
SUMMARIZING.
THE COMMITTEE WAS UNANIMOUSLY IN
SUPPORT BECAUSE OF THE UNIQUE
ASPECTS THIS PROGRAM PROVIDES A
AS MUCH AS THAT CANNOT BE
SUBSUMED BY ANY OTHER TYPE OF
ENTITY WITHIN THE COUNTRY AND
PROVIDING -- CONDUCTING PHASE 2
AND PHASE 3 TRIALS THAT CAN
ACCUMULATE LARGE NUMBERS OF
PATIENTS AND HAVE IDENTIFIED A
NUMBER OF PARADIGM-SHIFTING
RESULTS THAT HAVE RESULTED IN
IMPROVEMENTS IN CELLULAR THERAPY
AND OUTCOMES FOR PATIENTS WITH
LEUKEMIA AND MYELOMA AND REDUCE
TOXICITY AS WELL AS EXPENSES,
IT'S A UNIQUE PROGRAM THAT'S
HAD, AS KIM SAID, STELLAR
RESULTS.
>>JUST TO MENTION LORI AND TEAM
DID A GREAT JOB RESPONDING TO
THINGS WE RAISED.
A WONDERFUL CONCEPT.
WE STRONGLY SUPPORT IT.
>>SAM?
>>A QUICK QUESTION HOW DATA ARE
COLLECTED, STANDARDIZED,
RELATIONSHIP BETWEEN THIS
PROGRAM AND THE DATA THAT ARE
COLLECTED BY THE CIBMTR AND
WONDERING HOW THE DATA ARE
COORDINATED AND THEN USED FOR
SECONDARY RESEARCH IF AT ALL.
THANK YOU.
>>THE DATA IS COORDINATED
THROUGH THE CIBMTR.
THERE ARE OPPORTUNITIES WHICH
YOU CAN REQUEST THE DATA TO DO
THE SECONDARY ANALYSES.
THERE'S SUPPORT AND DEVELOPMENT
OF THE DATASET WHICH TO ACHIEVE
THAT.
>>DO YOU KNOW IF THE DATA ARE
COLLECTED IN THE DICTIONARY
FORMAT OR TRANSFORMED AFTER
COLLECTION AND IF NOT THERE'S
CERTAINLY AN OPPORTUNITY THERE
TO HELP IMPROVE THE WAY DATA ARE
COLLECTED SO THAT IT'S EASIER TO
TRANSMIT AND DON'T HAVE TO
TRANSFORM, BUT THAT MAY BE A
SEPARATE ISSUE.
>>YEAH, I DON'T KNOW THAT
OFFHAND.
>>THANK YOU.
>>ANDREA?
>>AT RISK OF SOUNDING LIKE A
NAYSAYER, SEVEN YEARS AND A LOT
OF MONEY, WHAT IS THE PROCESS
FOR EVALUATION OR UPDATES I
GUESS, WILL WE BE ABLE TO
RECEIVE A THREE TO FIVE YEAR
REPORT OR ANNUAL REPORT OR HOW
IS IT GOING TO BE COMMUNICATED?
>>SO, AT THE PRESENT PROGRAM
STAFF RECEIVABLE PROGRESS
REPORTS, AND WE ALSO PARTICIPATE
IN THE STEERING AND EXECUTIVE
COMMITTEE MEETINGS WHERE WE HEAR
ABOUT THE PROGRESS AT LEAST
MONTHLY.
WHETHER OR NOT THAT GETS
CONVEYED TO THIS COMMITTEE IS I
THINK A SEPARATE QUESTION.
I DON'T THINK IT'S SOMETHING
WE'VE DONE IN THE PAST EXCEPT
FOR TIMES LOOKING TOWARDS
REISSUING THE RFA.
I DON'T HAVE THAT HISTORICAL
KNOWLEDGE TO SAY IT'S BEEN DONE
OUTSIDE OF THAT.
>>DESIRES TO HAVE A
PRESENTATION THREE TO FOUR YEARS
OUT, PRIOR TO THE END OF THIS
REISSUANCE, THAT CAN BE JUMPED
ON.
>>OKAY.
>>SEEMS LIKE A LONG TIME, SO
MANY THINGS CHANGE IN SCIENCE,
ET CETERA.
SEVEN YEARS JUST SEEMS LIKE A
LONG TIME.
PERHAPS IT WOULD BE HELPFUL EVEN
TO THE PERSONS INVOLVED TO HAVE
AN EVALUATION SORT OF THREE TO
FOUR YEARS INTO IT.
>>WE CAN CERTAINLY DO THAT BUT
THESE ARE PHASE 3 TRIALS.
>>I UNDERSTAND.
>>YEAH, YEAH.
>>WE'VE GOT TO MOVE ON.
>>OKAY.
WE'LL MOVE TO VOTING.
REISSUANCE.
SAM, TAKE YOUR HAND DOWN FROM
QUESTIONS.
MOTION'S BEEN MADE.
KIM, IF YOU CONFIRM MOTION TO
CONCUR.
>>MOVE TO CONCUR.
>>AND SECOND?
>>SECOND.
>>THANK YOU.
FURTHER DISCUSSION?
OKAY.
HEARING NONE, MOTION IS FOR
CONCURRENCE, LOOKING FOR ANY
VOTES OF NON-CONCURRENCE.
OR VOICE STATUS IF YOU'RE UNABLE
TO RAISE YOUR HAND
ELECTRONICALLY.
I SEE AND HEAR NONE, NO RECORDED
ABSTENTIONS, IF ANYONE WOULD
LIKE TO ABSTAIN NOW PLEASE LET
ME KNOW.
OKAY.
PAULETTE, WE'RE GOOD?
>>WE'RE GOOD BUT WE DO HAVE ONE
CONFLICT, SO THE VOTE WILL BE 24
WITH ONE CONFLICT.
>>GREAT.
THANK YOU.
I'VE DONE A REASONABLY BAD JOB
OF KEEPING US ON TIME.
BUT WE HAVE THIS BUFFER PERIOD
OF A BREAK AND WE CAN
COLLECTIVELY PAY BACK FOR MY BAD
TIMEKEEPING.
>>WOULD IT BE POSSIBLE TO AVOID
THE BREAK AND JUST CHARGE
FORWARD AND STAY CLOSER TO TIME?
>>PAULETTE SHOULD ANSWER THAT.
SHE WILL SAY NO BUT I'M JUST --
>>ALL OF US NEED A BREAK.
WE'VE BEEN AT THIS SINCE 1:00.
>>WE COULD COME BACK ON THE
SCHEDULED TIME IN 12 MINUTES.
>>YEAH, BUT LET'S TAKE A
THREE-MINUTE BREAK AND COME
BACK, WE'LL HAVE A TEN-MINUTE
ADMINISTRATIVE SESSION.
>>SOUNDS GREAT.
JUST THREE MINUTES.
>>FINAL CONCEPT, SBIR 2B BRIDGE
AWARDS TOWARDS
COMMERCIALIZATION.
DR. JONATHAN FRANCA-KOH.
SUBCOMMITTEE HAS REVIEWED THE
MATERIALS AND DISCUSSED WITH THE
TEAM, RECOMMENDATION FOR
CONCURRENCE AND PRESENTATION.
JONATHAN, GO AHEAD WITH THE
PRESENTATION.
>>THANK YOU SO MUCH.
I'M PRESENTING THE BRIDGE AWARD
RFA, AND THIS IS PART OF A
LARGER CONGRESSIONALLY MANDATED
PROGRAM FROM THE SBIR, SMALL
BUSINESS INNOVATION RESEARCH.
SO, IT DRAWS ON THESE
CONGRESSIONALLY MANDATED
SET-ASIDE FUNDS, WILL NOT IMPACT
RPG FUNDING.
FEDERAL AGENCIES THAT HAVE LARGE
EXTRAMURAL R&D BUDGETS ARE
REQUIRED TO SET ASIDE 3.65%.
AT THE NCI THIS AMOUNTS TO $182
MILLION.
AND THIS IS OFTEN REFERRED TO AS
AMERICA'S SEED FUND BECAUSE THE
GOAL IS TO SUPPORT EARLY STAGE
INNOVATESSIVE SMALL BUSINESSES,
USED AT THE NIH TO SUPPORT THESE
COMPANIES.
CONGRESS REAUTHORIZED FOR THREE
MORE YOURS.
WE COMMISSIONED ECONOMIC IMPACT
EVALUATION IN 2018, WHICH LOOKED
AT THE 690 PHASE 2 AWARDS MADE
BETWEEN 1998 AND 2010.
AND THEY DETERMINED THE OVERALL
ECONOMIC IMPACT WAS
$26.1 BILLION, WHICH INCLUDES
THE SALES OF THE PRODUCTS AND
SERVICES, TO DATE, AS WELL AS
TAX REVENUES, LABOR INCOME.
SO NOW I'D LIKE TO GIVE A
SNAPSHOT OF WHERE THE PHASE 2B
BRIDGE AWARD PROGRAM FITS IN
WITHIN THE SBIR FUNDING
MECHANISM.
THE FIRST STAGE OF FUNDING
CALLED PHASE 1 PROVIDES UP TO
$400,000 IN FUNDING FOR EARLY
STAGE PROOF OF CONCEPT RESEARCH.
AND COMPANIES SUCCESSFUL THERE
TO APPLY FOR PHASE 2 FUNDING,
WHICH OFFERS UP TO $2 MILLION.
AND THIS TYPICALLY SUPPORTS
FURTHER PRE-IND, SOMETIMES EARLY
CLINICAL STUDIES.
COMPANIES DO HAVE THE OPTION TO
APPLY DIRECTLY FOR PHASE 2
FUNDING IF THEY HAVE SUBSTANTIAL
DATA ON HAND.
AND THERE IS AN OPTION FOR
WHAT'S CALLED FAST TRACK
APPLICATION, WHICH IS COMBINED
PHASE 1 AND PHASE 2 APPLICATION.
HOWEVER, THE GOAL IS NOT JUST TO
SUPPORT THE COMPANY'S RESEARCH
AND DEVELOPMENT TO GET THEM
TOWARDS COMMERCIALIZATION.
AND THE PHASE 1 AND PHASE 2
GRANTS CAN TAKE COMPANIES ONLY
SO FAR.
MANY PROMISING TECHNOLOGIES FACE
A FUNDING GAP TO REACH THE NEXT
KEY VALUE INFLECTION POINT, IT
CAN BE CHALLENGING TO TRACT
INVESTMENT FOR EARLY STAGE
COMPANIES BECAUSE OF THE RISK
INVOLVED.
AND WITHOUT THIS FURTHER FUNDING
TECHNOLOGIES CAN WITHER OR FACE
SIGNIFICANT DELAYS.
THAT'S WHY THE BRIDGE AWARD
PROGRAM COMES IN.
IT ADDRESSES THE CHALLENGE BY
PROVIDE BE COMPANIES WITH
ADDITIONAL FUNDING, BUT ALSO
REQUIRES THEM TO RAISE MATCHING
FUNDS, AT LEAST 1:1 MATCH.
THIS WAS THE FIRST NIH SBIR
PROGRAM OF ITS KIND, LAUNCHED IN
2009 ORIGINALLY.
IT ALLOWS INVESTORS TO SUPPORT
TECHNOLOGIES VETTED BY THE PEER
REVIEW PROCESS AND THAT HAVE
BEEN DERISKED WITH NIH FUNDING
YOU.
FROM THE NCI PERSPECTIVES ALLOWS
US TO SUPPORT TECHNOLOGIES
UNDERGONE RIGOROUS DUE DILIGENCE
BUT TO COMPANIES THAT SHOW THEY
CAN ATTRACT OUTSIDE INVESTMENT.
THE PROGRAM IN ITS LAST
ITERATION PROVIDES UP TO $4
MILLION IN FUNDING OVER 2 OR 3
YEARS, AND SUPPORTS TECHNOLOGY
VALIDATION AND CLINICAL
TRANSLATION IN ALL PORTFOLIO
AREAS.
IN TERMS OF ELIGIBILITY, THEY
CAN APPLY PROVIDED TECHNOLOGY IS
RELEVANT TO THE NCI MISSION, AND
CLINICAL TRIALS ARE OPTIONAL BUT
MAJORITY OF GRANTS DO SUPPORT
CLINICAL TRIALS.
WE THINK OF THIS PROGRAM AS
HAVING THREE MAIN OBJECTIVES,
HELPING COMPANIES ACCOMPLISH
CRITICAL MILESTONES, HELPING
THEM TO ESTABLISH PARTNERSHIPS
WITH KEY PLAYERS IN THEIR
ECOSYSTEM, AND TO HELP THEM
LEVERAGE THE FEDERAL FUNDING TO
ATTRACT PRIVATE INVESTMENT THAT
EQUALS OR EXCEEDS NCI FUNDS.
THIS IS A SNAPSHOT OF AWARDS TO
DATE.
SINCE 2009, 49 AWARDS, $126
MILLION IN NCI FUNDING.
WITH THIS COMPANIES LEVERAGED TO
RAISE OVER $500 MILLION IN
MATCHING FUNDS, SOURCES INCLUDE
TOP VENTURE CAPITAL, STRATEGIC
PARTNERS, ALSO ANGEL INVESTMENT
GROUPS.
IN TERMS OF PROJECT TYPES, SPANS
THE RANGE WITH DEVICES, IMAGING,
DIAGNOSTICS, THERAPEUTICS BEING
EQUALLY REPRESENTED.
AND FROM THE 49 AWARDS SO FAR 19
PRODUCTS HAVE BEEN LAUNCHED BY
THESE COMPANIES SO THAT'S A HIT
RATE OF ALMOST 40%.
BECAUSE OF TIME I'LL JUST
HIGHLIGHT ONE CASE STUDY FROM
RECENT AWARDEES.
A COMPANY WAS SPUN OUT OF
UNIVERSITY OF PENNSYLVANIA
AND THEY RECEIVED A BRIDGE AWARD
IN 2018 TO DEVELOP A SMALL
MOLECULE, ORIGINALLY IDENTIFIED
USING R01 FUNDS.
THE AWARD SUPPORTED PHASE 2
CLINICAL TRIAL OF THEIR AGENTS,
RECEIVING FAST TRACK AND ORPHAN
DESIGNATION, THE RESULTS OF
CLINICAL TRIALS, THE COMPANY WAS
ACQUIRED BY CHIMERIX.
A STORY SHOWED THE CASE OF A
PATIENT ON ONE OF THESE TRIALS,
DIAGNOSED WITH DIPG, AGE 6, NOT
EXPECTED TO SURVIVE THE YEAR.
PROGNOSIS OVER FIVE YEARS WAS 1%
SURVIVAL.
THREE YEARS LATER, SHE'S NOT
ONLY SURVIVING BUT THRIVING WITH
TUMOR STABLE AT JUST 12% OF
ORIGINAL SIZE.
THE PARENTS AND DOCTORS
ATTRIBUTE HER SURVIVAL TO
ONC-201.
PART OF THE REISSUING PROCESS WE
DID GET AN EXTERNAL EVALUATION,
WHICH WAS IN THE BSA MATERIAL,
I'LL SUMMARIZE KEY RESULTS HERE.
SO THEY FOUND THAT THE PROGRAM
SUCCESSFULLY MET THE GOALS OF
HELPING COMPANIES ACCOMPLISH
MILESTONES, ESTABLISH MILESTONES
AND ATTRACT INVESTMENT, 2016 TO
2020 TO SEE THE IMPACT OF RECENT
BRIDGE AWARDS.
THEY FOUND THE MATCHING FUND
REQUIREMENT WAS A KEY PROGRAM
FEATURE, IT HELPED PUSH
COMPANIES TO SEEK INVESTMENT AND
NOT JUST RELY ON GRANTS.
IT DID HELP ENTICE PRIVATE
INVESTMENT AND COMPANIES
REPORTED THAT THE PRESTIGE AND
VALIDATION PROVIDED BY BRIDGE
AWARD WAS JUST AS IMPORTANT AS
FUNDING.
THIS IS A QUOTE FROM ISOPLEXIS.
THEY SAID NCI BACKING HELPED THE
VCs CONNECT DOTS AND DETERMINE
IT WAS A BET THEY WERE WILLING
TO TAKE, THE BRIDGE WAS A
DE-RISKING THEY NEEDED AT THAT
MOMENT.
THEY FOUND THE PROGRAM SUPPORTS
KEY EARLY DEVELOPMENT ACTIVITIES
THAT ARE BEYOND SCOPE OF A JUST
TRADITIONAL PHASE 2 SBIR GRANT,
HELPING THEM TO ATTRACT PRIVATE
INVESTMENT AS A STAGE THAT'S
DIFFICULT HENCE THE TERM VALLEY
OF DEATH.
THEY REPORTED COMPANIES ARE
FACING INCREASED COSTS DUE TO
INFLATION, AND THEY FELT IT WAS
IMPORTANT THE BRIDGE AWARD
ACCOUNT SO COMPANIES CAN
CONTINUE TO HIT THEIR MILESTONES
AND SO THEY RECOMMEND MODEST
INCREASE IN AWARD CENTERS.
PROVIDED THAT WE CAN MAINTAIN
THE NUMBER OF BRIDGE AWARDS PER
YEAR.
OVER THE LAST FIVE YEARS RANGES
HAS BEEN BETWEEN 3 AND 6 AWARDS
A YEAR, RECOMMENDED SUPPORTING
THE HIGHER END.
WE'RE ASKING FOR FIVE-YEAR
APPROVAL FROM BSA, TO MAINTAIN
CLINICAL TRIALS OPTIONAL, WE'RE
REQUESTING INCREASE IN AWARD
SIZE FROM $4 MILLION TO
$4.5 MILLION, AND WE ANTICIPATE
FUNDING ABOUT SIX AWARDS PER
YEAR, THAT WOULD MAKE THE FIRST
YEAR SET ASIDE OF $12 MILLION.
AND THE FIRST YEAR SET ASIDES
OVER FIVE YEARS AMOUNTING TO $60
MILLION.
AND THE EVALUATION COMMITTEE
RECOMMENDED PROGRAM RENEWAL.
SO I'LL TOUCH ON MY LAST SLIDE,
RFA JUSTIFICATION, SO WE THINK
RFA MECHANISM HELPS SIGNAL NCI
STRONG COMMITMENT TO THIS
PROGRAM AND HELPS ENCOURAGE
PARTICIPATION FROM AWARDEES,
INVESTORS, STRATEGIC PARTNERS,
IMPORTANT FACTOR HELPING US TO
ENSURE THAT THE STUDY SECTIONS
HAVE STRONG REPRESENTATION FOR
REVIEWERS TO HAVE INDUSTRY
BACKGROUND AND STRONG BUSINESS
EXPERTISE, BECAUSE THESE
APPLICATIONS ARE MUCH MORE
FOCUSEDDED ON COMMERCIALIZATION
WITH SPECIAL REVIEW CRITERIA
THAT WOULD BENEFIT FROM INDUSTRY
PERSPECTIVE.
THESE INCLUDE VERY BALANCED
CONSIDERATION OF BOTH TECHNICAL
AND COMMERCIAL MERIT, EVALUATION
OF INTELLECTUAL PROPERTY
POSITION, REGULATORY STRATEGY,
FUNDRAISING PLAN.
IN RECENT YEARS THE AVERAGE THAT
WE'VE HAD ON OUR BRIDGE AWARD
PANELS HAS BEEN AROUND 40%, FOR
INDUSTRY PANEL MEMBERS, COMPARED
TO 25% FOR THE REGULAR STUDY
SECTIONS.
AND OUR OFFICE DIRECTOR IS ON
THE LINE TO ANSWER QUESTIONS.
>>THANKS.
DAVE, GET US STARTED.
>>THANK YOU.
THE THREE OF US MET WITH DR.
FRANCA-KOH LAST YEAR TO ASK
QUESTIONS ABOUT THE PROGRAM,
LEARNED A LOT ABOUT THE HISTORY
OF THE PROGRAM.
AND JONATHAN EXPLAINED IT ALL
VERY WELL.
SYLVIA AND MYSELF WERE NOT WELL
AWARE OF THE SBIR PROGRAM AND
HOW IT PROGRESSED TO PHASE 3 OR
BRIDGE PROGRAM AND IMPORTANCE ON
DEVELOPMENT OF CERTAIN ACADEMIC
AND PRIVATE SECTOR
ACCOMPLISHMENTS INTO FULL
FUNDING AND MOVING FORWARD TO
COMMERCIALIZATION.
WE LEARNED ABOUT THE PROCESS,
HOW THE STUDY PUT TOGETHER,
CRITERIA FOR ASSESSING MERITS OF
PROPOSALS.
AND ALSO LEARNED FROM THE
ASSESSMENT OF OUTSIGNED PANEL
THEIR DEEP UNDERSTANDING OF HOW
IT MET OBJECT I WAS PUT FORTH BY
CONGRESS INITIALLY AS WELL AS
2009 OBJECTIVES, 40% RETURN ON
INVESTMENT, BETTER THAN ANY
BUSINESS MODEL I'VE HEARD OF.
WE ASKED, AGAIN, A FAIR NUMBER
OF QUESTIONS ABOUT THE PROGRAM,
IN THE END WE WERE SATISFIED
WITH THE ANSWERS.
THE REASON WHY WE ASKED FOR THIS
TO BE DISCUSSED WITH THIS WHOLE
GROUP IS NOT BECAUSE WE HAD
PROBLEMS WITH THE PROPOSAL OR
SERIOUS CONCERNS BUT RATHER AT
LEAST TWO OF THE THESE ARE
MEMBERS ON THE COMMITTEE WERE
NAIVE TO THE PROCESS IN THE
BEGINNING THAT THE REST OF YOU
HEAR ABOUT IT SO YOU CAN TELL
YOUR COLLEAGUES IN ACADEMIA
ABOUT IT.
THE NEXT SPEAKER IS A VETERAN OF
THE PROGRAM AND SPOKE TO'DED A
VALUE FOR HIS OWN RESEARCH AND
THOSE OF HILLS COLLEAGUES.
ONE LAST THOUGHT I'LL LEAVE YOU
WITH, YESTERDAY WE SAT THROUGH
THE FIRST, IN MY MIND,
EXPLANATION OF WHAT ARPA-H IS.
WHY DO WE HAVE ARPA-H?
WE HAVE IT BECAUSE PEOPLE DON'T
THINK WE'RE GOING TO FINISH THE
JOB.
ACTUALLY THIS PROGRAM IS ONE,
AGAIN, ON A SMALLER SCALE,
TAKING ACADEMIC DISCOVERIES INTO
THERAPIES, DIAGNOSIS, NEW
COMPUTATIONAL APPROACHES, AND SO
WHENEVER WE GET THAT CHANCE WE
SHOULD REMIND THOSE OFFICIALS
WHO THINK WE HAVEN'T BEEN DOING
IT WE'RE ACTUALLY WORKING ON
THIS RIGHT NOW.
I'M GOING TO TURN IT OVER TO DR.
BESICH.
>>THIS IS A VERY IMPORTANT
PROGRAM.
BIG T TRANSLATION MEANS OUT TO
THE REAL WORLD, INTO THE HANDS
OF HUNDREDS OF THOUSANDS AND
MILLIONS OF USERS IS WHAT THIS
PROGRAM ASPIRES TO HELP
ACCELERATE.
AGAIN, BOTH AS BEING FUNDED BY
SBIR CURRENTLY HAVING A FOURTH
START-UP, AND UNDERSTANDING HOW
IMPORTANT THIS IS IN THE
ACADEMIC ECOSYSTEM TAKING GOOD
IDEAS FROM THE LABORATORIES AND
BIG T TRANSLATING THEM INTO REAL
THINGS THAT MATTER IS KEY.
ONE THING I'D LIKE TO ADVOCATE
I'VE WATCHED THE NCI'S PROGRAM A
COUPLE DECADES, THEY HAVE A TEND
OF TENDENCY TO POINT INITIATIVES
IN THE KEY AREAS THAT IMPACT US,
IMAGING, GENOMICS, A.I., MACHINE
LEARNING.
THIS IS AN IMPORTANT PROGRAM,
AND I ENTHUSIASTICALLY ENDORSE
IT.
>>THANK YOU.
SYLVIA IS MARKED AS NOT BEING
ABLE TO PARTICIPATE, JUST
CONFIRMING SYLVIA IS NOT WITH
US.
WE'LL MOVE TO OTHER BOARD
MEMBERS.
>>THANK YOU, KEITH.
THIS SEEMS TO BE A REALLY
IMPORTANT CATALYST.
THE QUESTION I HAVE MAYBE
UNDERSTANDING IS EXTENT TO WHICH
THERE'S DIVERSITY IN THE SBIR
PROGRAM, ONE, BUT ALSO IN THE
BRIDGE PROGRAM.
CLEARLY IT PROVIDES
OPPORTUNITIES, TAKING THEM TO
MARKETS, MAYBE WHAT IS THE OTHER
PROCESS HOW YOU SEEK TO
DIVERSIFY THE PEOPLE WHO ARE
LEVERAGING THIS PROGRAM AND THE
SECOND QUESTION, TANGENTALLY,
ALMOST, HOW THIS IS GOING TO
BRIDGE.
FIRST IS ABOUT DIVERSITY AND THE
PROCESS YOU HAVE.
>>YEAH, SO WE HAVE SEVERAL
PROGRAMS TO HELP THE DIVERSITY.
I THINK RIGHT NOW IT'S FOCUS ON
PHASE 1, PHASE 2 GRANTS, RATHER
THAN THE BRIDGE.
SO WE HAVE A PROGRAM CALLED THE
APPLICATION ASSISTANCE PROGRAM,
WHERE WE TARGET RESEARCHERS WITH
UNDERREPRESENTED BACKGROUNDS, TO
RECEIVE ADDITIONAL HELP FROM A
GRANT-WRITING COMPANY THAT CAN
HELP THEM NAVIGATE THE
APPLICATION PROCESS, AND
DEVELOPING THEIR APPLICATIONS.
WE CONDUCT OUTREACH EVENTS,
TARGETING COMMUNITIES AND
ORGANIZATIONS TO HELP US BETTER
REACH UNDERREPRESENTED GROUPS,
AND THROUGH THOSE EFFORTS WE
PROVIDE EDUCATION AND TRAINING.
THE PROGRAM DIRECTORS ARE ALWAYS
AVAILABLE TO SPEAK WITH
APPLICANTS TO DISCUSS THEIR
APPLICATIONS PRIOR TO SUBMITTING
THEM.
AND PROVIDE GUIDANCE THERE.
OUR AAP, APPLICATION ASSISTANCE
PROGRAM, 53 OF THESE PEOPLE THAT
WE GAVE THAT SUPPORT TO, 53 OF
THEM WERE COMPANIES THAT HAD
FOUNDERS OF UNDERREPRESENTED
BACKGROUNDS.
>>WHAT DOES THAT MEAN EXACTLY?
WHAT DOES THAT ACTUALLY MEAN?
>>YEAH, SO UNDERREPRESENTED
MINORITIES IN THE LIFE SCIENCES.
AND ALSO WOMEN.
SORRY.
>>I THINK IT WOULD BE HELPFUL,
THAT'S A BIG BUCKET, IMPRESSIVE
BUT THE BIG BUCKET AND MORE TO
MY POINT TO ENCOURAGE YOU TO
LOOK AT HOW YOU CAN BE MORE
INTENTIONAL ABOUT HOW YOU -- HOW
THE PROGRAM IS IMPLEMENTED AND
DESIGNED, KNOWING THE VALUE THAT
IT PROVIDES, HOW THAT MIGHT BE
LEVERAGED TO HELP CREATE MORE
DIVERSITY.
I THINK IN PART BECAUSE IT'S
QUITE A BIT OF MOVEMENT
NATIONALLY ABOUT DIVERSITY, SO
WHO IS PROVIDING SERVICES AND
MANY EFFORTS AROUND HOW YOU LOOK
AT POTENTIAL PEOPLE THAT CAN BE
PART OF YOUR POOL, AND ACTUALLY
DOING OUTREACH DIRECTLY TO THEM,
ASSIST IN THAT PROCESS.
>>YES, INCREASING DIVERSITY IS
A BIG EFFORT OF OURS GOING
FORWARD, WITH OTHER PROGRAMS AND
INITIATIVES.
>>WE'RE GOING TO BE PRESSED FOR
TIME WITH HANDS UP.
KAREN, GO AHEAD.
>>THANKS FOR A GREAT
PRESENTATION.
INTERESTING PROGRAM.
I WAS WONDERING IF YOU COULD
COMMENT ON THE EXTENT TO WHICH
POPULATION HEALTH AND BEHAVIORAL
TECHNOLOGIES ARE ACKNOWLEDGED
INTO THE SBIR/STTR PROGRAM, THE
BRIDGE FUNDING CATEGORIES YOU
MENTIONED DIDN'T SEEM TO BE
FOCUSED ON THOSE KINDS OF
TECHNOLOGIES BUT IT SEEMS THERE
ARE MANY BEING DEVELOPED THROUGH
RESEARCH, mHEALTH, e-HEALTH
THAT COULD BE APPROPRIATE.
>>YEAH, THANKS.
I DON'T HAVE THE FIGURES ON
HANDP FOR THOSE CATEGORIES BUT
OVERALL FUNDING WE DO -- IT IS
AN IMPORTANT PART OF OUR
PORTFOLIO.
I THINK IN THAT KIND OF SPACE WE
FUND DIGITAL HEALTH,
SOFTWARE-BASED PROJECTS, LOOKING
AT DIFFERENT ASPECTS OF
POPULATION HEALTH, AND I CAN
THINK OF GRANTS WE FUNDED IN
TRYING TO PROMOTE DIVERSE
REPRESENTATION IN CLINICAL
TRIALS, SOFTWARE PLATFORMS TO
HELP PATIENTS MANAGE THEIR CARE
BETTER AND ACCESS PREVENTIVE
CARE, THINGS LIKE THAT.
THAT'S ABOUT 8% OF OUR PORTFOLIO
FROM MY UNDERSTANDING.
IN TERMS OF BRIDGE AWARDS, THAT
HAS NOT -- I DON'T THINK WE
FUNDED MANY IN THAT SPACE.
THERE HAVE BEEN APPLICATIONS BUT
FOR ONE REASON OR ANOTHER THEY
DIDN'T GET SELECTED.
>>HOWARD?
>>YOU'RE STILL MUTED, HOWARD.
BOB, MAYBE MOVE TO YOU.
>>OKAY.
I'M BACK.
>>GO AHEAD.
>>DO WE CARE IF FUNDED SPECIFIC
GOALS FOR FUNDED ORGANIZATION IS
FOR A POSITIVE CONTRIBUTION TO
THE U.S. AND PATIENT CARE WITH
CANCER, OF COURSE.
THE DATA WE'RE GIVEN ABOUT THE
SUCCESSES AND SUBSEQUENT FUND
RAISES AND EXITS THAT ARE REALLY
CENTERED AROUND ACHIEVING THAT
GOAL, I'VE SEEN TOO MANY
ANECDOTES WITH SBIR
PRESENTATIONS WHERE THERE'S A
DISCONNECT, A GROUP GOT A PHASE
2 LARGE AWARDS, WAS PRESENTED TO
US, HAD A BREAST CANCER GENOMIC
ASSAY, THEY EXITED, AND WERE
BOUGHT OUT BY A U.K. COMPANY.
U.K. NEVER BROUGHT FORWARD THE
BREAST CANCER GENOMIC ASSAY,
NEVER COMMERCIALIZED, NO BREAST
CANCER PATIENTS EVER GOT AN
ADVANTAGE OUT OF IT, AND INSTEAD
THEY WENT OFF AND TOOK THE MONEY
AND DEVELOPED A LUNG CANCER
PROGRAM.
I DON'T KNOW IF I CARE.
I THINK THAT'S NOT A BAD THING
FOR THE LUNG CANCER POPULATION,
BUT I'M WONDERING IF THE -- IF
STATISTICS WE'RE HEARING, THAT
IT'S NEEDED, ABOUT THE SPECIFIC
GOAL, YOU KNOW, SUCCESSING PART
OF WHERE -- SUCCESSES IS PART OF
WHERE THE FUNDING IS GOING.
>>PART OF THE MANDATE FROM
CONGRESS IS TO MAKE THAT
POSITIVE CONTRIBUTION TO THE
U.S. ECONOMY.
WE ALSO CARE ABOUT THE PATIENT
IMPACT AND FIGURE IF WE TRACK --
MICHAEL, DO YOU WANT TO ADDRESS
THIS QUESTION?
>>YEAH, ACTUALLY, JONATHAN.
YOU CAN.
TALK ABOUT THE MANDATE FOR A
CERTAIN AMOUNT OF DOLLARS TO BE
OUTBOUND FOR PROGRAMS LIKE THIS
AS PART OF THE CONGRESSIONAL
BUDGET REQUIREMENTS BECAUSE I
THINK THAT'S THE KEY TO
UNDERSTANDING WHY THIS PROGRAM
REMAINS IMPORTANT.
AND DESPITE THE CHALLENGES THAT
I THINK ARE POINTED OUT MY
MEMBERS OF THIS GROUP I THINK
THE EDUCATION IS REALLY NEEDED
JUST AS A SOLUTION PIECE.
WE RECOGNIZE IN PITS BURKE.
WHAT WE'VE DONE WITH R25 TO
BRING BRIGHTEST MINDS TO BEAR A
CONNER IS RESEARCH CONNECTED TO
SBIR AND STTR TO BRING DIVERSE
FEMALE LEADERS IN THE X-RAYS TO
ACCOMPLISH GOALS.
WHY DON'T YOU COMMENT ON THE
ALLOCATION REQUIRED FOR THIS
TYPE OF COMMERCIALLY
OUTBOUND-RELATED ACTIVITIES.
>>YES, SO THE CONGRESSIONAL
MANDATE IS THAT 3.65% OF SET
ASIDE OF THE EXTRAMURAL R&D
BUDGET TO SUPPORT SMALL
BUSINESSES THROUGH THE SBIR AND
STTR PROGRAMS, WITH THE GOAL OF
HELPING INNOVATION THROUGH THESE
COMPANIES, IMPACT PATIENTS, AND
BENEFIT THE U.S. ECONOMY
OVERALL.
>>SYLVIA WANTED US TO MAKE SURE
WE BROUGHT THAT OUT IN THE
CONVERSATION SO I'M CHANNELING
SYLVIA RIGHT NOW.
>>GO, BOB.
>>THANKS.
MEASURED IS WHAT GETS DONE.
IF THERE'S EFFORTS TO PRIORITIZE
AND FUND A GROUP, BASED ON A --
[AUDIO DISTORTION]
ACCESS TO UNDERSERVED OR
OVERSERVED, I DON'T CARE, ANY OF
THE AMERICAN POPULATION, AND
THEN THAT JUST DOESN'T HAPPEN
BECAUSE THE FUNDING GETS -- IT
WOULD BE NICE TO I THINK
UNDERSTAND THIS WHETHER, YOU
KNOW, HOW THE FUNDING
ACHIEVEMENTS SORT OF MATCH BASED
ON THE SPECIFIC AIMS OF WHY THEY
WON THAT FUNDING AND HOW THAT
TRANS--
[AUDIO DISTORTION]
CARE, IMPROVING CARE OF PATIENTS
WITH CANCER IN OUR POPULATIONS.
I THINK WE CARE ABOUT THAT TOO.
>>YES, AND, YOU KNOW, OUR
FUNDING MANDATE IS NOT THAT OF A
TRADITIONAL -- NOT JUST LOOKING
AT ECONOMIC IMPACT.
AND SO WE DO HAVE PROGRAMS FOR
EXAMPLE ON RARE AND PEDIATRIC
CANCERS, PROGRAMS FUNDING, YOU
KNOW, HEALTH DISPARITIES, SO
WE'RE NOT ONLY INTERESTED IN
THAT WILL OVERALL RETURN.
THAT'S SOMETHING A LOT OF PEOPLE
CARE ABOUT.
THAT'S WHY WE COMMISSIONED THAT
STUDY.
BUT, YES, I DID NOT MEAN TO GIVE
THE IMPRESSION THAT'S OUR ONLY
GOAL.
YOU'RE RIGHT, WE NEED TO KEEP
THAT BIG PICTURE IN MIND.
>>OKAY.
WE'RE A FULL TEN MINUTES OVER.
BOB, REAL QUICK AND TREY AND
ANN, MAYBE YOU COULD SUBMIT
QUESTIONS THROUGH THE CHAT OR
COMMENTS.
>>REAL QUICK QUESTION FOR ME.
YOU KNOW, THIS IS A WONDERFUL
PROGRAM.
I SUPPORT IT COMPLETELY.
BUT THE ONE THING THAT'S NOT
BEEN DISCUSSED IS THE ECONOMIC
CLIMATE IN WHICH ONE HAS TO
CONSIDER WHETHER THESE MATCHING
FUNDS, INVESTMENTS FROM OUTSIDE
CAN BE ACHIEVED AND RIGHT NOW
ESPECIALLY NOW, YOU KNOW, THAT
VALLEY OF DEATH IS GETTING WIDER
AND DEEPER, AND I'M JUST
WONDERING HOW YOU'RE THINKING
ABOUT THIS IN TERMS OF SOMEHOW
LINKING WHAT YOU EXPECT FOR
MATCHING FUNDS TO BE SOMEHOW
LINKED TO THE INVESTMENT
CLIMATE.
>>I THINK, YES, GREAT POINT,
AND GIVEN THE INVESTMENT CLIMATE
I THINK THE BRIDGE AWARD PROGRAM
IS PARTICULARLY IMPACTFUL NOW
BECAUSE COMPANIES ARE FINDING IT
HARDER TO RAISE FUNDS.
THE CLOSEST EXPERIENCE WE HAVE
ARE, YOU KNOW, HOW THE PROGRAM
PERFORMED IN PREVIOUS ECONOMIC
DOWNTURNS, AND THERE WE DID FIND
COMPANIES WERE ABLE TO RAISE THE
MATCHING FUNDS.
I'D HAVE TO LOOK AT -- COMPARE
AMOUNTS PERHAPS BUT THE FEEDBACK
WE'RE GETTING IS THIS KIND OF
INCENTIVE AND ABILITY FOR
FEDERAL FUNDS TO LEVERAGE
PRIVATE INVESTMENT IS VERY
ATTRACTIVE IN THIS CLIMATE.
>>GREAT.
THANK YOU.
>>SORRY TO CUT OFF DISCUSSION.
LET'S MOVE TO VOTING.
AGAIN, THIS IS REISSUANCE,
SUBCOMMITTEE HAS ALREADY
INDICATED THEIR INTENT TO MOTION
FOR CONCURRENCE.
DAVE, CAN YOU QUICKLY CONFIRM
THAT?
>>I MOTION FOR CONCURRENCE
>>SECOND?
>>SECOND.
>>GREAT.
FURTHER DISCUSSION?
>>JUST THE CAVEAT ABOUT THE
DIVERSITY OF THE PROGRAM.
>>YES, NOTED.
THANK YOU.
>>JUST ON THE RECORD.
THAT'S ALL.
>>ABSOLUTELY, YEP.
>>I SUPPORT IT 100%.
>>UNDERSTOOD.
ANYONE ELSE?
OKAY.
LOOKING FOR ANY VOTES OF
NON-CONCURRENCE.
BY ELECTRONIC HAND OR VOICE.
I SEE NONE.
AND I DO NOT HAVE ANY RECORDED
ABSTENTIONS.
ANY LAST-MINUTE ONES?
I DO NOT SEE ANY.
PAULETTE, I THINK WE'RE OKAY.
>>IT'S UNANIMOUS.
>>OKAY.
THANKS, ALL.
APOLOGIES FOR THE CLOCK
MANAGEMENT.
JOHN, YOU'RE INHERITING A
DEFICIT.
BACK TO YOU.
>>NO PROBLEM.
THANKS, KEITH.
I THINK AT THIS POINT WE WILL BE
CONSIDERING ONGOING AND NEW
BUSINESS IN TERMS OF ONGOING
BUSINESS, THERE WERE THREE NCAB
COMMITTEE MEETINGS ON MONDAY THE
5th, THE CHAIRS WILL GIVE THE
REPORT.
NCAB WILL VOTE ON THOSE REPORTS.
I DO HAVE A QUESTION, PAULETTE.
THE REPORT FROM ELECTRA AND
ELENA WAS GIVEN THIS MORNING.
WE VOTED.
DO WE NEED TO DO IT AGAIN.
IT'S ON THE AGENDA.
>>WHAT YOU VOTED ON THIS
MORNING WAS THE WORKING GROUP
REPORT.
>>GOT IT.
>>IT'S A SUBCOMMITTEE.
>>GOT IT.
GREAT.
LET'S START THE FIRST
SUBCOMMITTEE REPORT WILL BE
GIVEN BY FRANCIS WHO IS CLAIRE
CHAIR
OFFED -- OF THE AD HOC COMMITTN
GLOBAL RESEARCH.
CAN YOU UNMUTE?
>>I'LL SAY I HAVE TO APOLOGIZE,
LAST TWO DAYS I'VE BEEN GREAT.
I'M OUT OF THE COUNTRY.
THE PAST COUPLE HOURS I'VE BEEN
HAVING MY INTERNET COME IN AND
OUT.
I HOPE IT WILL STAY ON.
CAN YOU HEAR ME?
>>YES.
>>GOOD.
I HOPE IT HOLDS THIS WAY.
THE AD HOC SUBCOMMITTEE MET TWO
DAYS AGO, A COPY OF THE FULL
SUBCOMMITTEE MEETING REPORT HAS
BEEN SENT TO ALL OF YOU.
MY PRESENTATION WILL BE A
SUMMARY OF SOME OF THE
HIGHLIGHTS OF THE MEETING AND
OUR DISCUSSIONS.
EYE REFER -- I REFER YOU TO THE
FULL MEETING REPORT.
THE CHARGE OF THE SUBCOMMITTEE
IN A NUTSHELL TO ADVISE NCAB AND
NCI DIRECTOR ON STRATEGIC
APPROACHES TO ENHANCE
CONTRIBUTION OF THE NCI TO
GLOBAL CANCER RESEARCH.
THE PROCESS, THE SUBCOMMITTEE
PROVIDES LEADERSHIP, EXPERTISE,
INPUT ON INITIATIVES, CONCEPTS,
PARTNERSHIPS, TO HELP IDENTIFY
AND PRIORITIZE CHALLENGES AND
NEW OPPORTUNITIES FOR THE NCI
AND GLOBAL CANCER RESEARCH.
SUBCOMMITTEE WAS PLEASED TO
WELCOME DR. BERTAGNOLLI,
EMPHASIZING GLOBAL NATURE OF
CANCER, SCIENTISTS AND
PHYSICIANS MUST ADDRESS NEEDS OF
THE WORLD WIDE COMMUNITY WHILE
ADDRESSING THEIR OWN
COMMUNITIES.
REMARKS WERE REASSURING,
RESTATEMENT OF THE SUPPORT
GLOBAL CANCER RESEARCH HAS
ENJOYED FROM PREVIOUS NCI
DIRECTORS ESPECIALLY IN THE PAST
DECADE FROM HAROLD VAIR VARMUSD
SHARPLESS AND DOUG LOWY.
WE LOOK FORWARD TO CONTINUED
SUPPORT.
TWO MAIN ITEMS OF BILLS FOR THE
SUBCOMMITTEE, FIRST WAS UPDATE
BY THE DIRECTOR OF THE CENTER
FOR GLOBAL HEALTH, AND
APPOINTMENT HAS NO BETTER TIME
THAN THE START OF THE COVID-19
PANDEMIC.
HOWEVER THE CONSTRAINTS OF THE
PANDEMIC WITH HIS LEADERSHIP THE
CENTER IS ON A VERY STRONG PATH
ACROSS THE INSTITUTE WITH
VARIOUS PARTNERS, THE VISION IN
LINE WITH THE STRATEGIC PLAN.
I BELIEVE THE STRATEGIC PLAN IS
AVAILABLE ONLINE, UPON REQUEST
FROM THE CDH.
KEY ELEMENTS WITH THIS WILL
CENTER AROUND RESEARCH,
TRAINING, DISSEMINATION,
PARTNERSHIPS, DETAILS OF
ACTIVITIES REPORTED TO THE
SUBCOMMITTEE AND EACH OF THESE
THEMATIC AREAS I REFER YOU TO
THE DETAILED REPORT.
TWO EXAMPLES, FIRST IS THE
AFFORDABLE CANCER TECHNOLOGIES
PROGRAM, PROVIDING GRANT SUPPORT
FOR LATE STAGE TESTING AND
VALIDATION OF CONTROL
TECHNOLOGIES IN LOW- AND
MIDDLE-INCOME COUNTRIES,
SUCCESSFUL PROGRAM, I'VE
PRESENTED EXAMPLES AT SUCCESSES
FOR THE PROGRAM.
AN RFA WAS REISSUED.
THE OTHER IMPORTANT THEMATIC
AREA THAT I'D LIKE TO MESSAGE,
ACTIVITIES IN THE AREA OF
TRAINING AND CAPACITY BUILDING
CARRIED OUT BOTH EXTRAMURALLY
AND INTRAMURALLY.
THE CENTER IS USING D43 AWARD
MECHANISM TO SUPPORT BUILDING OF
GLOBAL CANCER RESEARCH TRAINING
NETWORKS, TO ENCOURAGE LMIC
INSTITUTIONS TO DEVELOP
PARTNERSHIPS WITH NCI-DESIGNATED
CANCER CENTERS, THE KEY THING,
IT'S NOT WITHIN THE U.S. BUT AT
THE VARIOUS COUNTRIES, BUT
INTRAMURALLY HOWEVER THE
ACTIVITIES, ONE IS RESUMPTION OF
SHORT-TERM PROGRAM IN THE FALL
OF THIS YEAR, LMIC SCIENTISTS
COME TO THE NCI AND GAIN
TRAINING AND EXPERTISE.
AND THEY HAVE AWARDED FOUR --
MAILED FOUR AWARDS, AND CENTER
FOR CANCER RESEARCH, DIVISION OF
CANCER EPIDEMIOLOGY AND
GENETICS, THE HOPE IS THESE
INDIVIDUALS WILL GO BACK TO THE
LMICs AND HOPEFULLY BUILD
CAPACITY THERE.
IN DISCUSSION THE SUBCOMMITTEE
NOTED SIGNIFICANT PROGRESS AND
REPOSITION SINCE DR. KOPAL
ASSUMED LEADERSHIP.
THE PARTNERSHIPS THAT ARE BEING
BUILT WITH OTHER STAKEHOLDERS
WITH FOGARTY INSTITUTE, NCI
DESIGNATED CANCER CENTERS,
PROFESSIONAL ORGANIZATIONS, AND
INDUSTRY, TO ADVANCE THE GLOBAL
CANCER RESEARCH PROGRAM.
THIS PROGRESS NOT WITH STANDING,
THE SUBCOMMITTEE FELT THERE WAS
STILL SIGNIFICANT OPPORTUNITIES
IN THE CANCER RESEARCH AGENDA,
ENCOURAGE TO CONTINUE
DEVELOPMENT IN THESE ACTIVITIES.
IMPORTANTLY, THIS WILL ALLOW THE
CD8 TO LEVERAGE FOR ACTIVITIES
SUCH AS RESEARCH INFRASTRUCTURE
DEVELOPMENT AND WITHOUT THAT
DEVELOPMENT THE COMMITTEE FELT
THAT THE EXPERTISE WILL HAVE
LIMITED IMPACT.
ON ANOTHER NOTE, CAPACITY
BUILDING WAS ENCOURAGED TO HELP
REDUCE AGENDA AND DISPARITY IN
THE WORK FORCE IN LMICs.
SECONDLY, LASTLY, THE
COMMITTEE -- ANOTHER IMPORTANT
SUBJECT OF BUSINESS FOR THE
SUBCOMMITTEE WAS REPORT ON
SURVEY OF GLOBAL ACTIVITIES, AT
NCI DESIGNATED CENTERS PRESENTED
BY THE HEAD OF THE PROGRAM AT
INDIANA UNIVERSITY, NCI
DESIGNATED CANCERS, ASCO, TO
PROVIDE OVERVIEW OF GLOBAL
ONCOLOGY ACTIVITIES TO ADVANCE
GLOBAL ONCOLOGY SUCH AS BY
TRACKING TRENDS IN GLOBAL
ONCOLOGY RESEARCH, IDENTIFY
AREAS AND OPPORTUNITIES FOR
FUNDING.
THE PROGRAM WAS INITIATED 2012,
REPEATED EVERY TWO YEARS.
A LARGE BODY OF DATA WAS
PRESENTED.
SOME OF IT IS SUMMARIZED IN THE
REPORT SO I WILL JUST MENTION
THIS, A FEW THINGS.
THIS YEAR, OR LAST YEAR, 71
CANCER CENTERS WERE CONTACTED TO
SEND IN A SURVEY, ALL BUT FOUR
COMPLETED, AN INCREDIBLE I THINK
FEAT.
OF THE 67, REPORTED THAT THEY
HAD GLOBAL ONCOLOGY ACTIVITIES,
SIGNIFICANT NUMBER OF THEM, 42%,
HAD AN OFFICE, PROGRAM DEDICATED
TO GLOBAL CANCER RESEARCH.
ONLY 9% ARE NO GLOBAL ONCOLOGY
ACTIVITY.
69% HAD NIH FUNDING, 43 HAD
PHILANTHROPIC FUNDING,
SURPRISINGLY NO GOVERNMENTAL
FUNDING FROM AGENCIES SUCH AS
CDC OR USAID
20%, AND U.S. CORPORATIONS
INDUSTRY WAS ONLY 16%.
ANOTHER INTERESTING FINDING WAS
THAT MAJORITY OF THE NIH FUNDING
WENT TO STUDY BIOLOGY, ETIOLOGY,
DIAGNOSIS/PROGNOSIS, AND
TREATMENT.
RELATIVELY LESS TO PREVENTION.
AND EQUALLY INTERESTING WAS MOST
OF THE NIH FUNDING WENT TO
CANCER DIAGNOSIS/PROGNOSIS AND
TREATMENT.
THESE RESULTS I THINK COULD BE
VERY USEFUL TO THE NCI AND CGH,
TO SEEK PARTNERSHIPS AND
COLLABORATORS, GAPS IN THE
GLOBAL ONCOLOGY PORTFOLIO.
I BELIEVE THE RESULTS OF THE
STUDY WILL BE PUBLISHED BUT I'M
SURE THEY WILL BE AVAILABLE TO
THOSE INTERESTED FROM THE NCI
UPON REQUEST.
LASTLY THE SUBCOMMITTEE
CONSIDERED BRIEFLY THE PROSPECT
OF LEVERAGING OPPORTUNITIES IN
THE NEWLY LAUNCHED MOONSHOT 2.0,
FOR INCREASED VISIBILITY AND
POTENTIALLY RESOURCES FOR THE
CGH AND NCI GLOBAL CANCER
RESEARCH AGENDA.
THESE DISCUSSIONS ARE IN THE
EARLY STAGES AND MORE
SPECIFICALLY INITIATIVES WILL BE
PRESENTED AT FUTURE MEETINGS.
I'LL STOP HERE AND AGAIN REFER
YOU TO THE MEETING REPORT YOU
RECEIVED FOR MORE DETAILS AND
ANSWER ANY QUESTIONS YOU MAY
HAVE.
>>THANKS, EXCELLENT SUMMARY OF
THE REPORT.
THANK YOU SO MUCH.
ARE THERE ANY QUESTIONS FOR
FRANCIS?
YES, I SEE SHELLY'S HAND.
>>I JUST WANT TO ASSURE THE
COMMITTEE THAT THE CENTER IS IN
EXTRAORDINARY HANDS, BY SOMEBODY
WHO WAS ON THE GROUND, AND
DEVELOPED A PROGRAM WITH
EXTRAORDINARY PASSION,
COMPETENCE, BOTH CLINICAL AND
SCIENTIFIC ABILITY, AN INSPIRED
LEADER FOR THIS GROUP.
>>TREMENDOUS.
>>THANKS, SHELLY.
DOROTHY, DID I SEE YOUR HAND UP?
>>YOU SURE DID.
A QUESTION REGARDING THE
INFRASTRUCTURE DEVELOPMENT LMIC
COUNTRIES.
WHEN YOU TALK ABOUT
INFRASTRUCTURE, ARE YOU THINKING
ABOUT DEVELOPING RESEARCH HUBS
WHAT CAPACITY TRAINING OCCURS,
PEOPLE COME IN AND LEARN
RESEARCH METHODOLOGIES OR
BUILDING LABORATORY CAPACITY?
WHAT IS YOUR VISION OF
DEVELOPING OR WHAT IS
COMMITTEE'S VISION OF DEVELOPING
THE INFRASTRUCTURE WITHIN THOSE
LMICs?
>>VERY, VERY IMPORTANT QUESTION
BECAUSE WE TRAIN ALL THESE
PEOPLE IN NEW METHODS, THEY GO
BACK AND CAN'T APPLY, FORGET HOW
OR MOVE TO OTHER THINGS.
SO, I THINK IT WAS GREAT VISION,
ABOUT FOUR OR FIVE YEARS AGO,
THE NCI CTA ACTUALLY HAD A
PROGRAM WHERE THEY WANTED AT
LEAST I THINK TWO OR THREE
COUNTRIES IN DIFFERENT REGIONS
OF THE LMICs TO COME TOGETHER,
FORM A HUB, PROVIDE SEED FUNDING
FOR THEM TO INITIATE SUCH AN
INFRASTRUCTURE TO DO EXACTLY
WHAT YOU JUST SAID AND MORE.
IN THESE DAYS OF SPECIALIZED
MEDICINE, YOU NEED GOOD LABS,
MOLECULAR LABS AND SO ON TO CARE
FOR THESE TUMORS.
RATHER THAN HAVING THEM COME
OVER HERE, RATHER TO ENCOURAGE
THEM TO SET UP THESE, IF I WERE
TO REDO THAT AGAIN I WOULD
ALMOST LIKE WHAT WE JUST SAID,
THE GOVERNMENTS TO ALSO HAVE A
CONTRIBUTION, TO MATCH THE FUNDS
THAT WOULD BE AVAILABLE.
THIS WAS BROUGHT UP AT OUR
MEETING, AND DR. GOPAL SAID THE
PROCESS, NOT CONTINUING IN THAT
SAME FASHION BUT RATHER WOULD
TAKE THEMES, SOME OF THE THEMES
THAT I MENTIONED, AND DEVELOP
PROJECTS AROUND THOSE BECAUSE
BUILD AN INFRASTRUCTURE IS VERY
EXPENSIVE, MAYBE NOT POSSIBLE
WITH THE RESOURCES THEY HAVE.
WE THOUGHT IN THE PARTNERSHIPS
THAT WOULD BE DEVELOPED, THERE
MIGHT BE ADDITIONAL STAKEHOLDERS
THAT WOULD BE INTERESTED IN
HELPING BUILD THOSE.
BUT FRANKLY WITHOUT AN
INFRASTRUCTURE TO DO THIS WORK,
A LOT OF TRAINING WOULD
EVENTUALLY JUST -- ALL THOSE
PEOPLE WOULD STAY BACK IN THE
U.S. OR OTHER COUNTRIES WHERE
THEY CAN PRACTICE.
THE INFRASTRUCTURE TRAINING
ALMOST LIKE GO HAND IN HAND, BUT
IT'S A BIG CHALLENGE BECAUSE IT
TAKES A LOT OF MONEY TO DO THAT.
>>I HAD A QUESTION.
I'LL ASK ANYWAY.
WHO DECIDES THE DESIGNATION FOR
LOW AND MIDDLE INCOME, HOW OFTEN
IS IT UPDATED?
THERE WERE SOME COUNTRIES WITH
HIGH GLOBAL ECONOMIES ON THE
LMIC LIST, HOW OFTEN IS THAT
REVIEWED, DOES THE NIH NCI HAVE
TO SORT OF UTILIZE A DEFINITION
BASED ON A DIFFERENT AGENCY?
I'M TRYING TO FIGURE THAT OUT.
>>LET ME ASK FOR PAULETTE'S
HELP.
IS THIS A TERM --
>>IT'S A UNITED NATIONS
DESIGNATION.
>>OKAY, U.N. DESIGNATION,
GREAT.
>>BUT YOU'RE RIGHT, IT'S A
SPECTRUM.
SOME LIKE GHANA, NIGERIA, SOUTH
AFRICA HAVE INFRASTRUCTURE THAT
CAN BE LEVERAGES, OTHERS HAVE
PRACTICALLY NOTHING.
>>EXACTLY.
OKAY.
GREAT.
ANY OTHER QUESTIONS FOR FRANCIS
BEFORE WE GO TO VOTE?
SO NCAB WILL VOTE AND WE'RE
VOTING TO ACCEPT THE
SUBCOMMITTEE REPORT.
DO WE HAVE A MOTION TO ACCEPT
THE REPORT?
>>SO MOVED.
>>SECOND?
>>SECOND.
>>PROPERLY MOVED AND SECONDED.
QUESTIONS?
OKAY.
SO ARE THERE ANY NAYS?
OR ABSTENTIONS?
PAULETTE?
>>YOU'RE GOOD.
>>OKAY, GOOD.
WE'LL MOVE TO THE NEXT
SUBCOMMITTEE REPORT, GIVEN BY
DR. ELECTRA PASKETT, POPULATION
SCIENCE EPIDEMIOLOGY AND
DISPARITIES.
>>THANK YOU.
THE NCAB SUBCOMMITTEE ON
POPULATION SCIENCE EPIDEMIOLOGY
AND DISPARITIES MET ON MONDAY
AFTERNOON, AND THE 99% OF OUR
TIME WE SPENT REVIEWING THE
REPORT FROM THE WORKING GROUP
THAT WAS ALREADY PRESENTED TO
YOU ALL EARLIER THIS AFTERNOON.
WE HAD A LITTLE LONGER
PRESENTATION.
WE HAD ROBUST DISCUSSION.
VERY NICE DISCUSSION.
AND THE DISCUSSION IS VERY
NICELY CAPTURED IN THE MINUTES
THAT WERE CIRCULATED.
THE REPORT WAS THEN APPROVED BY
THE SUBCOMMITTEE, TO BE
PRESENTED TODAY TO NCAB.
AND PAULETTE, I DO BELIEVE THERE
WAS A LITTLE MIXUP WITH THE VOTE
THIS AFTERNOON BECAUSE IT SHOULD
HAVE ONLY BEEN NCAB MEMBERS THAT
WERE VOTING.
>>IT WAS 14-1.
>>BUT THE 1 WAS NOT AN NCAB
MEMBER.
>>OH, IS THAT RIGHT?
OKAY.
SO IT WAS 14.
>>YEP.
I WANTED TO CLEAR THAT UP,
PAULETTE, FOR THE MINUTES.
THANKS.
>>APPRECIATE IT, ELECTRA.
>>I APPRECIATE ALL THAT YOU DO,
I REALLY DO.
AND YOU KEEP US STRAIGHT SO I
REALLY APPRECIATE THAT.
SO, THE ONE THING THAT WE DIDN'T
HAVE A LOT OF TIME TO GET INTO
WAS WHAT THE SUBCOMMITTEE WOULD
FOCUS ON NEXT AND SO I ASKED THE
SUBCOMMITTEE MEMBERS TO THINK
ABOUT WHAT WE WOULD TALK ABOUT
NEXT, AND THE OPPORTUNITY THAT
WE DO HAVE TO MEET WE WOULD LIKE
TO MEET, IN THE PAST WE HAD
SEVERAL TOPICS ON OUR PLATE AND
DR. SHARPLESS HAD COUNSELED US
TO JUST DO ONE TOPIC AT A TIME
SO WE NOW COMPLETED TWO REPORTS.
DR. ROBISON SO CHAIRED THE ONE
ON THE EPIDEMIOLOGY COHORT.
THAT WAS WONDERFULLY DONE.
AND THIS IS OUR SECOND REPORT.
SO, I'M HAPPY TO ANSWER ANY
QUESTIONS IF ANYBODY HAS ANY BUT
I DON'T WANT TO REITERATE WHAT
WE'VE ALREADY TALKED ABOUT
TODAY.
DR. SPITZ, HELLO.
>>TWO ISSUES.
NUMBER ONE, I APOLOGIZE, I HAD
TO TEMPORARILY LEAVE THE MEETING
WHEN WE VOTED ON THE REPORT.
I WOULD HAVE ABSOLUTELY -- MY
VOTE WOULD HAVE BEEN POSITIVE
AND I ACCEPT IT.
SO PLEASE COULD THAT BE
RECORDED.
NUMBER TWO, ELECTRA YOU'VE DONE
A FANTASTIC JOB, I CAN'T THINK
OF ANYONE WHO WOULD HAVE DONE IT
AS WELL OR CAREFULLY AND
EFFICIENTLY AS YOU.
ONE POINT WE BROUGHT UP SEVERAL
TIMES, WHICH PERHAPS WE COULD
CONSIDER ADDRESSING IS THE ISSUE
OF FUNDING OPPORTUNITIES FOR
TRAINEES IN POPULATION SCIENCE.
AS WE KNOW, THE KO 7 HAS GONE
AWAY, R25 HAS BEEN EXTENSIVELY
CHANGED.
AND WE HAVE BROUGHT THIS UP ONCE
WITH I RECALL DR. SHARPLESS, HE
AGREED IT WAS IMPORTANT, PERHAPS
THAT'S SOMETHING WE COULD
CONSIDER FOR DISCUSSION BUT I
OBVIOUSLY RESPECT WHATEVER THE
COMMITTEE DECIDES TO DO NEXT.
>>RIGHT.
FIRST LET ME THANK YOU,
MARGARET.
YOU'RE SO NICE WITH YOUR
COMPLIMENTS.
I DO HAVE TO SAY THAT IT WAS AN
ENTIRE COMMITTEE WORK, AND THE
CO-CHAIRS AND DR. CASTLE REALLY,
REALLY CONTRIBUTED AND I CAN'T
THANK ENOUGH ALL OF THEIR
ASSISTANCE IN PUTTING THAT ALL
TOGETHER.
SO IT REALLY WAS A GROUP
ACTIVITY.
THANK YOU VERY MUCH.
I DO REMEMBER THAT WE TALKED
ABOUT THAT BECAUSE A LOT OF THE
OPPORTUNITIES FOR TRAINEE
FUNDING HAS GONE AWAY.
AND SO WE DID TALK ABOUT THAT.
I MADE A LIST.
AND I THINK, MARGARET, YOU MIGHT
REMEMBER ONE OF THE OTHER IDEAS
WAS TALKING ABOUT CLINICAL TRIAL
ACRUCIAL. -- ACCRUAL.
>>BROUGHT UP BY DR. SHARPLESS.
THOSE WERE THE THREE BIG AREAS
THAT WE HAD DISCUSSED.
OBVIOUSLY WE FOCUSED FIRST ON
THE ONES YOU'VE ALREADY DONE.
>>YES, RIGHT.
OKAY, THANKS.
I MADE A NOTE OF BOTH OF THOSE.
THAT'S WONDERFUL.
THANK YOU, MARGARET.
>>DOROTHY?
>>IS IT OKAY IF I CALL ON
PEOPLE?
>>YES, SURE.
>>OKAY.
DOROTHY?
>>OKAY.
I'M UNMUTED.
SO, ELECTRA, A REALLY WONDERFUL
REPORT.
I GUESS ONE OF THE THINGS THAT
YOU POINTED OUT THE FACT THAT
THE BIOLOGY AND TREATMENT, NOT
VERY MANY PROJECTS THAT HAD
REPRESENTATION OF THE
UNDERREPRESENTED, AND I'M
WONDERING I THINK YOU TALKED
ABOUT THE RECOMMENDATION YOU
TALKED ABOUT REALLY WAS TO
FACILITATE MORE RESEARCH OVERALL
AMONG THE UNDERREPRESENTED
POPULATION BUT IT SEEMS LIKE THE
WHOLE BIOLOGY AREA IN PARTICULAR
AND PROBABLY TREATMENT IT LOOKS
LIKE REALLY STRUGGLE WITH
RECRUITING UNDERREPRESENTED
POPULATIONS AND I'M WONDERING
WHETHER THAT MIGHT NOT BE AN
IMPORTANT FOCUS BECAUSE I KNOW
ON CCSGs THAT'S A CHALLENGE, A
TOPIC THAT COMES UP AS A
CHALLENGE.
>>YES, THANK YOU, DOROTHY.
YOU ADEQUATELY CHARACTERIZED OUR
SUMMARIES, AND I THINK AS I
EXPLAINED, WE DIDN'T ASSESS
CLINICAL TRIAL ACCRUAL.
SO, WE LOOKED AT ARE THERE
RESEARCH PROJECTS GOING ON IN
THE AREA OF TREATMENT BASED ON,
YOU KNOW, THE DATA MINING WE
COULD IDENTIFY IN THOSE CFO
CODES, AND THOSE POPULATIONS.
AND BUT I DO BELIEVE THAT YOUR
COMMENTS ARE LENDING SUPPORT TO
WHAT MARGARET AND I TALKED ABOUT
FOR ONE OF THE AREAS THAT DR.
SHARPLESS MENTIONED, THIS
COMMITTEE COULD LOOK INTO,
CLINICAL TRIAL ACCRUAL OF THESE
POPULATIONS.
THANK YOU, DOROTHY.
I DON'T SEE ANY MORE HANDS
UNLESS I'M MESSING MESS -- MISM
ON THE SECOND PAGE.
>>JOHN, IS A QUESTION OKAY?
A QUICK ONE.
I'M WONDERING IF IMMUNOTHERAPY,
CANCER TREATMENT, IS THAT
SOMETHING YOU DISCUSS A LOT?
>>IN OUR SUBCOMMITTEE WE
HAVEN'T SPECIFICALLY CALLED OUT
IMMUNOTHERAPY BUT I DO KNOW --
>>OR IMMUNO-ONCOLOGY IN
GENERAL.
>>I DO KNOW IMMUNO-ONCOLOGY HAS
INCLUDED POPULATION SCIENTISTS
IN A VARIETY OF ASPECTS.
SO, FOR EXAMPLE, LOOKING AT
SYMPTOMS, HOW TO MANAGE
SYMPTOMS, FOR EXAMPLE, ADHERENCE
COULD BE, YOU KNOW, ANOTHER
THING BUT I DO KNOW THERE IS A
ROLE TO INCLUDE POPULATION
SCIENCE IN THAT AREA.
MARK?
>>JUST ONE COMMENT, WHEN YOU
THINK ABOUT -- IF THIS SHIFTS IN
THE FUTURE TO CLINICAL TRIALS
ENROLLMENT OR TREATMENT TRIALS
ENROLLMENT OR BIOLOGY, ANY OF
THOSE, A WISE PERSON, WE HAVE
SEVERAL COMMUNITY ADVISORY
BOARDS, ONE IS A TRIBAL ADVISORY
COUNCIL, AND THIS COMMENT WAS
FOCUS SHOULDN'T JUST BE ON THE
POPULATION, SHOULD ALSO BE ON
THE RESEARCHERS.
AND THE RESEARCHERS NEED INPUT
ON THE COMMUNITIES.
IT'S BIDIRECTIONAL.
AND THE COMMUNITIES FEEL THE
RESEARCHES SAY WE WANT YOUR
DATA, SO AS YOU THINK ABOUT THAT
GOING FORWARD THINK ABOUT
OUTREACH TO THE RESEARCH
COMMUNITY AS WELL AS THE
POPULATIONS.
>>THANKS.
SORT OF WHAT THE HEART OF COE
IS, RIGHT, MARK?
>>YEAH, EXACTLY.
>>NO FURTHER QUESTIONS, THE
NCAB MEMBERS SHOULD VOTE TO
ACCEPT THE REPORT.
IS THERE A MOTION TO ACCEPT?
>>I MOVE.
>>SECOND?
>>SECOND.
>>PROPERLY MOVED AND SECOND.
A QUESTION?
>>GO AHEAD.
>>IF NOT, WE CAN -- NCAB
MEMBERS SHOULD VOTE.
ANY NAYS?
ANY ABSTENTIONS?
PAULETTE?
>>IT'S UNANIMOUS.
>>COULD I ASK A QUESTION?
>>UH-HUH.
>>YOU CAN.
>>PAULETTE, THE REPORT THAT WE
SUBMITTED, I'VE HAD SEVERAL
PEOPLE ASK ME WHEN THAT WILL BE
MADE PUBLIC OR AT LEAST BE ABLE
TO REFERENCE.
DO YOU KNOW WHAT THE PROCESS IS
WITH THE REPORTS?
>>IT WILL BE POSTED ON THE
WEBSITE WITHIN THE NEXT 24-48
HOURS.
>>OKAY.
THANK YOU VERY MUCH.
APPRECIATE THAT.
>>OKAY.
>>THANK YOU.
THE LAST AND FINAL REPORT
SUBCOMMITTEE REPORT TO BE
PRESENTED WILL BE BROUGHT TO
BROUGHT US BY
DR. AZAD, CLINICAL
INVESTIGATIONS.
>>THE SUBCOMMITTEE MET MONDAY,
5th, DECIDED TO LOOK AT THE
SURVEY THAT HAD BEEN
ADMINISTERED TO NCTN SITES TO
REALLY UNDERSTAND HOW THE SYSTEM
HAD BEEN OPERATING SO THE
RECOMPETE FOR THE FOLLOWING
YEAR, HOW THAT COULD BE CRAFTED
TO ADDRESS ANY CONCERNS AS WELL
AS CONTINUE TO CAPITALIZE ON
SUCCESSES.
THE SUBCOMMITTEE ON CLINICAL
INVESTIGATIONS, THE FULL REPORT,
ALL OF YOU RECEIVED THIS MORNING
BUT AS A BRIEF SUMMARY, OUR
MISSION IS TO FOCUS ON HOW TO
ADVISE NCAB AND NCI ON TRIALS
THAT ARE FOCUSED ON DETECTION,
PREVENTION, DIAGNOSTICS,
MANAGEMENT, AND TREATMENT.
WE'RE RESPONSIBLE FOR A BROAD
RANGE OF CONCERNS, HOW TO
IMPROVE CLINICAL INVESTIGATIONS
IN HUMAN BEINGS.
WE ALSO INVITE -- ADVICE ON THE
NCTN PROGRAM, AND AS I MENTIONED
THIS YEAR IS THE YEAR THAT THE
RECOMPETE FOR THE NCTN
REFORMATTED PROGRAM IS MOVING
FORWARD SO THE SURVEY THAT WAS
CONDUCTED WAS CONDUCTED
REGARDING THE PERFORMANCE OF THE
NCTN OVER THE PAST THREE YEARS
FROM MARCH OF 2019 THROUGH JULY
OF 2022.
WE INVITED DR. MOONEY, ASSOCIATE
DIRECTOR OF THE CANCER THERAPY
EVALUATION PROGRAM, CTEP, TO
PRESENT RESULTS OF THE SURVEY.
SHE FIRST BEGAN WITH A SUMMARY
OF THE PROGRAM SO THIS IS A
PROGRAM THAT WAS FOUNDED IN
2014, NCTN PROGRAM,
RECONFIGURATION OF COOPERATIVE
GROUPS TO HARMONIZE PROCESSES
AND PROMOTE COLLABORATIONS,
INVIGORATE NCI CLINICAL TRIALS
PORTFOLIO WHICH HAD BEEN HAVING
CHALLENGES PRIOR TO THIS.
OBJECTIVES WERE TO CONTINUE
FOCUSING ON QUESTIONS THAT ARE
NOT PARTICULARLY WELL SUPPORTED
IN NORMAL COMMERCIAL
ENVIRONMENTS PRIORITIZED STUDIES
THAT INCORPORATE BOTH INNOVATIVE
SCIENCE BUT ALSO LOOKING AT
LARGE SCALE TESTING OF SMALL
SUBSETS OF MOLECULAR DEFINED
CANCERS TO BE NCI MATCH TRIAL IS
AN EXAMPLE OF THAT KIND OF
INITIATIVE THAT WAS UNDERTAKEN
THROUGH THE NCTN SO LARGE SCALE
TESTING OF SMALL SUBSETS OF
MOLECULAR DEFINED PATIENTS AND
ALSO LOOKING AT RARE TUMORS
WHICH IS A CHALLENGE TO DO AND
MORE TRADITIONAL CLINICAL TRIAL
NETWORKS OR IN COMMERCIAL
ENTITIES.
THE NCTN IS COMPOSED OF SEVERAL
CENTRALIZED FUNCTIONS, THERE'S A
REVIEW BOARD, CLINICAL TRIALS
SUPPORT UNIT, RADIATION THERAPY
AND IMAGING CORE CENTER,
STEERING REVIEW COMMITTEE, THAT
CAN BE TUMOR BASED OR COMMON
HISTOLOGY BASED, COMMON DATA
MANAGEMENT SYSTEMS.
EACH NCTN GROUP HAS ITS OWN LEAD
ACADEMIC SITE AS WELL AS
STATISTICS AND DATA MANAGEMENT,
OPERATIONS, AND ITS OWN TUMOR
BANK.
SO THE SURVEY THAT WAS GIVEN WAS
OPEN FROM JULY 25 THROUGH AUGUST
26, 2022, 335 INDIVIDUALS
RESPONDED TO THE SURVEY.
AND 254 COMPLETED THE SURVEY IN
ITS ENTIRETY.
WHAT'S IMPORTANT ABOUT WHAT'S
HAPPENED OVER THE LAST FEW YEARS
EVEN IN THE ERA OF COVID, AFTER
A FEW MONTHS OF HAVING DECREASED
ACCRUALS ON THE NCTN WE HAD
MAINTAINED ACCRUALS ACROSS THE
NCTN THAT WAS CONSISTENT BEFORE
AND AFTER COVID.
THE SURVEY RESULTS OVERALL
SHOWED THAT THERE WAS GREAT
SATISFACTION IN THE PROGRAM,
ESPECIALLY COMPARED TO THE YEARS
BEFORE SO IF WE LOOK AT DECEMBER
2016 TO AUGUST 20, 22, THERE WAS
AN INCREASE IN SATISFACTION FOR
THE PROGRAM AND OVERALL THE
REPORT FROM THE SURVEY WAS QUITE
POSITIVE.
BUT THERE WERE RECURRENT AREAS
THAT WERE POTENTIAL PLACES FOR
OPTIMIZATION ESPECIALLY AS WE
LOOK FORWARD TO THE NEXT YEAR.
THIS INCLUDES HOW WE COULD
IMPROVE ENROLLMENT OF DIVERSE
POPULATIONS, LOOKING OVER THE
LAST TEN YEARS THERE HAS BEEN AN
INCREASE IN BOTH THE ABSOLUTE
NUMBER AND PERCENTAGES OF
MINORITY PATIENTS THAT HAVE BEEN
ENROLLED IN NCTN BUT STILL
HASN'T REACHED THE LEVEL OF THE
POPULATION WITHIN THE UNITED
STATES SO THERE'S STILL GREAT
OPPORTUNITY FOR CONTINUED
ENHANCEMENT OF ENROLLING DIVERSE
POPULATIONS AND VULNERABLE
PATIENTS THAT ARE NOT RECEIVING
ADEQUATE CARE.
MULTIPLE SITES ALSO TALKED ABOUT
THE IMPORTANCE OF HARMONIZING
DATA COLLECTION AND MINIMIZING
DATA COLLECTION, MINIMIZING
REDUNDANCY OF DATA COLLECTION,
AND HOW WE CAN STREAMLINE ISSUES
SO STAFF ARE ABLE TO OPEN MORE
TRIALS AND CLOSE MORE TRIALS
WHICH IS ALSO A CHALLENGE THAT
DIFFERENT SITES MENTIONED.
ANOTHER AREA OF POTENTIAL
OPTIMIZATION INCLUDES HOW MORE
JUNIOR FACULTY AND EARLY CAREER
INVESTIGATORS CAN BE INVOLVED IN
LEADERSHIP IN CLINICAL TRIALS
AND IN THE NCTN.
SOME SUGGESTIONS INCLUDED
LIMITING THE NUMBER OF TRIALS
THAT A PERSON CAN CHAIR AND
CONSIDERING TERM LIMITS FOR
COMMITTEE CHAIR ROLES AS WELL AS
INITIATIVES THAT HAPPEN, FOR
EXAMPLE, IN THE NCI MATCH WHEN
EARLY CAREER AND LATER CAREER
INVESTIGATOR WAS INVOLVED IN
EACH ARM OF THE TRIAL.
THERE WERE CONCERNS ABOUT
FUNDING IN THE NCTN SO
CENTRALIZED SERVICES HELP
SOMEWHAT BUT THERE'S
SIGNIFICANTLY LARGE COSTS
ASSOCIATED WITH BIOSPECIMEN
COLLECTION THAT IS REALLY NOT
WELL FUNDED, AS WELL AS FOR THE
PULL CONDUCT OF CORRELATIVE
SCIENCE.
DR. MOONEY I THINK DID A VERY
NICE JOB OF EXPLAINING WHAT
WE'RE ALL AWARE OF THAT INDUSTRY
SPONSORED STUDIES FOR MORE THAN
NCTN STUDIES ARE PRIORITIZED
HAVING FINANCIAL STRAIN AND THIS
IS FURTHER MAGNIFIED BY
WORKFORCE ISSUES THAT HAVE COME
UP DURING COVID BUT CONTINUE
WHEN IT COMES TO WORKFORCE AND
STAFF TURNOVER.
THERE WAS SOME UNCERTAINTY OR
DISCREPANCY BETWEEN SOME SITES
THAT WANTED MORE EARLY STAGE AND
EARLY PHASE CLINICAL TRIALS AND
OTHER SITES THAT WANTED MORE
LATE STAGE OR LATE PHASE TRIALS,
AND SO THAT LIKELY IS BASED ON
THE DIFFERENCE BETWEEN EACH
INDIVIDUAL SITE, AND IS REALLY
ABOUT TRYING TO HAVE A BALANCE
OF DIFFERENT KINDS OF STUDIES
THAT CAN SERVICE NEEDS OF A VERY
LARGE TRIAL PORTFOLIO AND SITE
PORTFOLIO WHERE EACH SITE MIGHT
HAVE DIFFERENT KINDS OF TRIALS
THAT IT MIGHT MOST ACTIVELY
ENROLL TO.
COVID-19 CREATED SOME
CHALLENGES.
THERE WERE SIX MONTHS OF
DECREASED ACCRUALS DURING THE
INITIAL PERIOD BUT MULTIPLE
POSITIVE THINGS CAME OUT OF OUR
ADAPTING TO THE COVID-19
PANDEMIC, AND THAT INCLUDED
BEING ABLE TO DO TELEHEALTH FOR
STUDY VISITS, ALLOWING PRIMARY
CARE PROVIDERS OR LOCAL HEALTH
PROVIDERS TO PERFORM STUDY
ACTIVITIES, REMOTE CONSENTING,
SHIPPING ORAL AGENTS TO
PATIENTS, REMOTE AUDITING, AND
ALL OF THESE ARE NOT NEW
STRATEGIES THAT COULD BE
UTILIZED GOING FORWARD, BOTH TO
HELP ENROLL MORE DIVERSE
POPULATIONS AS BEING ON A
CLINICAL TRIAL CAN BE BOTH
FINANCIALLY AND TIME-WISE A
STRAIN FOR PATIENTS.
BUT ALSO ALLOW DECREASING AMOUNT
OF STRAIN ON STAFF AS WELL.
SO OVERALL, PEOPLE HAVE BEEN
HAPPY BASED ON THE SURVEY, AND
ADVANCES THAT HAPPENED WITH THE
NCTN.
THERE ARE MANY THINGS FROM THE
LAST FIVE YEARS THAT SHOULD BE
MAINTAINED AND CONTINUED, BUT
THERE ARE OPPORTUNITIES THAT WE
REALLY NEED TO TAKE ADVANTAGE OF
IN A NEW RFA THAT WE MAY WANT TO
IMPROVE ON, AND THAT INVOLVES
WAYS THAT WE CAN DECREASE THE
DATA BURDEN ON DIFFERENT SITES,
CREATE EFFICIENCY WITH
CENTRALIZATION, PRIORITIZE
JUNIOR FACULTY INVOLVEMENT AS
WELL AS DIFFERENT INITIATIVES O
INCREASE DIVOT TRIALS -- DIFFER,
- DIVERSITY, ON THE
TRIALS.
WE HAD COMMENTS FROM COMMITTEE
MEMBERS, AS WELL AS NCAB AND BSA
MEMBERS THAT FOCUSED ON MULTIPLE
ISSUES THAT WERE COMING OUT OF
THE SURVEY.
THERE WAS A COMMON CONSENSUS
THAT NCAB MEMBERS UNDERSTAND
THAT MORE FUNDING IS REALLY
NECESSARY, AND THERE WAS
CONVERSATION REGARDING TRYING TO
DO SOME MORE DATA ANALYSIS
AROUND WHAT COSTS ARE FOR
CONDUCTING TRIALS, SO HOW WE
MIGHT BE ABLE TO BETTER ADVOCATE
FOR MORE FUNDING FOR THE NCTN
STUDIES, AS WELL AS POTENTIALLY
HOW WE MIGHT REJIGGER THE WAY
TRIALS ARE FUNDED.
THERE WAS A CONSENSUS ON THE
NEED TO FOCUS ON HOW WE MIGHT
CONTINUE TO IMPROVE ACCESS OF
THESE TRIALS TO PATIENTS THAT
ARE DIVERSE INCLUDING PATIENTS
WITH DIFFERENT SOCIOECONOMIC
ISSUES AND SO WE HAD A VERY
ROBUST DISCUSSION, AND I'LL
LEAVE THE REST OF THIS TO MORE
DETAILED READING OF THE MINUTES
FROM THAT MEETING.
>>FANTASTIC.
THANKS, NILO.
DO WE HAVE ANY QUESTIONS FOR
NILO?
YOU CAN MANAGE THE Q&A IF YOU
CAN SEE THE HANDS.
>>KAREN?
>>THANK YOU FOR THAT GREAT
OVERVIEW.
THAT WAS WONDERFUL.
>>IT GOT REALLY DARK AFTER I
SPOKE.
I DON'T KNOW IF THAT SAYS
SOMETHING ABOUT THE
PRESENTATION.
>>, YEAH WE WON'T COMMENT ON
THAT.
SO, ONE OF THE THINGS THAT I
THINK IS RELEVANT TO YOUR
PRESENTATION AND ALSO THE
CONVERSATION AROUND CLINICAL
TRIAL ENROLLMENT IS TO REALLY
THINK ABOUT THE DIFFERENT TIMES
OF PARTNERSHIPS AS YOU MAY BE
AWARE, THE WYNN SCHOLARSHIP
PROGRAM IS FOCUSED ON IMPROVING
NOT ONLY WORKFORCE DIVERSITY
WITH RESPECT TO CLINICAL
TRIALISTS BUT TRYING TO IMPROVE
PARTICIPATION, AND THERE IS AN
UPCOMING PARTNERSHIP WITH ASCO
WORKING WITH COOPERATIVE GROUPS,
INDIVIDUALS MAY BE TRAINED AS A
WIN
-- WYNN SCHOLAR TO THINK ABOUT
A GROUP THAT COULD BE A JUMPOFF
POINT FOR PEOPLE TRAINED.
I JUST WANTED TO MENTION THAT.
ASCO AND AAAC PARTNERED AROUND
DOING BASELINE DATA COLLECTION
AT DIFFERENT INSTITUTIONS AROUND
INCLUSIVE PARTICIPATION.
[AUDIO DISTORTION]
ANY OF THAT DATA WAS PART OF
YOUR ENVIRONMENTAL SCAN AS YOU
GUYS WERE THINKING OR DISCUSSING
ANY OF YOUR PROGRAMS.
>>SO THAT WAS NOT PART OF THIS
SURVEY OR CONVERSATION GOING
FORWARD BUT I THINK IT
ABSOLUTELY MAKES SENSE TO
INCORPORATE THAT.
I THINK OUR NEXT MEETING SHOULD
BE A HIGHLIGHTED TOPIC.
>>I JUST HAD A QUESTION.
YOU MENTIONED BRIEFLY ABOUT DATA
STREAMLINING AND I DON'T WANT TO
SPEND TOO MUCH TIME ON IT BUT
DID YOU COME UP WITH ANY
SOLUTIONS ABOUT HOW TO
CENTRALIZE AND STREAMLINE THE
DATA?
THAT'S ONE OF THE REALLY
CRITICAL ISSUES BEING ABLE TO BE
EFFICIENT IN THESE CLINICAL
TRIALS, LARGE AND SMALL SCALE.
>>YEAH, SO AT THE END OF THAT
CONVERSATION WE BEGAN TALKING
ABOUT HOW WE MIGHT BE ABLE TO
ADAPT THE RFA THAT'S GOING OUT
AS WELL AS HOW WE INSTRUCT THE
STEERING COMMITTEES AND WHO HELP
WITH THE PROTOCOL FORMATION.
TO STREAMLINE BOTH WHAT DATA IS
COLLECTED BUT THEN STILL
CONTINUE TO PRIORITIZE SOME DATA
THAT SOMETIMES ISN'T EVEN
COLLECTED.
THERE'S A BALANCE THERE.
SOME DEMOGRAPHIC DATA THAT WE'RE
NOT DOING A GOOD JOB OF
COLLECTING, BUT THEN THERE'S
LONG-TERM DATA THAT'S BEING
COLLECTED, I THINK THERE'S
THINGS THAT ARE NILES TO -- NICE
TO HAVE AND PUT A HUGE AMOUNT OF
BURDEN ON THE STAFF SO MOST OF
THAT IS TO -- DOESN'T APPEAR TO
BE PART OF THE NEW RFA BUT
SHOULD BE ABOUT THE BEST
OPERATING PRACTICES THAT ARE
ALSO -- THEY ARE THE NEXT THING
THAT THE CLINICAL INVESTIGATION
COMMITTEE IS PLANNING TO TAKE
YOU THE, DOING STANDARD
OPERATING PROCEDURES AROUND
CENTRAL FUNCTIONS OF THE NCTN,
THEY DO HAVE CONTROL OVER AND
COULD BE MODIFIED, WE JUST NEED
TO MAKE THAT A PRIORITY.
>>AND THEY ARE ALL USING THE
SAME SOFTWARE, RIGHT?
IT'S A MATTER OF STREAMLINING
DATA POINTS BEING COLLECTED?
>>YES AND THE TIMELINE OF HOW
LONG THEY HAVE TO BE COLLECTED.
>>THANK YOU.
>>A QUICK QUESTION.
I COULDN'T COME WHEN YOU HAD THE
MEETING.
A GREAT SUMMARY.
IT'S ABOUT THE PANDEMIC
EXPERIENCE, YOU TALKED ABOUT
SEVERAL THINGS IN CLINICAL
TRIALS THAT ARE BETTER, NOW
COULD BE DONE.
IT FELT SOFT.
I WASN'T SURE IF THERE'S A PLAN
TO FOLLOW WHAT YOU WERE SAYING
TO WRITE UP SOPs, CODIFY
TELEMEDICINE CAN BE USED IN THIS
SITUATION, YOU CAN USE PRIMARY
CARE PROVIDER TO DO EXAMS, YOU
CAN DO THE LABORATORIES, BECAUSE
I THINK THERE'S A REGRESSION
BACK TO OUR OLD PATTERNS OF
BEHAVIOR WHEN PEOPLE DON'T KNOW
WHAT'S REALLY OKAY AND WHAT'S
NOT.
>>SO I THINK THAT THERE WERE
MORE DETAILS IN THE PRESENTATION
AND THAT THOSE ABSOLUTELY ARE
GOING TO BE CODIFIED.
BOTH IN THE RFA GOING OUT BUT
MAYBE GOING BACK TO WHAT WE
TALKED ABOUT ANDREA, ALSO ABOUT
SOPs OF NCTN WITHIN
CENTRALIZED SERVICES COOPERATIVE
GROUPS ARE DOING, ABOUT
PROVIDING THAT CONTEXT AND THAT
OVERVIEW AND OVERSIGHT, AND THEY
ARE COMMITTED TO DOING IT.
AND I'VE SEEN IN MY OWN PROGRAM
THAT'S IN THE NEW ONES MOVING
FORWARD AS WELL.
>>ANYBODY ELSE?
>>WE CAN'T HEAR YOU.
>>ARE YOU CALLING FOR THE VOTE?
>>THERE WAS ONE MORE HAND.
>>HOWARD'S HAND IS UP.
>>THANK YOU.
I'M WONDERING ABOUT WHAT GETS
MEASURED IS WHAT GETS DONE, AND
TO MEASURE THESE MEMBERS BY
INVITING A SURVEY AND HEARING
ABOUT THEIR PLACE IS FINE
ALTHOUGH WE REALIZE IN THE
RANKING OF DATA, DECISION-MAKING
DATA, THAT'S LOW ON THE LIST,
RIGHT?
>>YES.
>>SURVEY IN GENERAL.
BUT THAT BEING SAID WONDERING
ABOUT OTHER QUESTIONS THAT MIGHT
BE ASKED THAT WOULD THEN HELP
REINFORCE BOTH THE QUALITY AND
DESIRABILITY OF PARTNERSHIPS OR
INDUSTRY PARTNERSHIPS, I'M
THINKING FOR EXAMPLE THERE WAS A
EUROPEAN COOPERATIVE GROUP WHERE
A VERY LARGE -- A U.S. COMPANY
HAD PROBLEMS WITH THOUSANDS OF
UNANSWERED QUERIES AND THEY WERE
TRYING TO PARTNER WITH THEM BUT
IT TOOK MONTHS AND MONTHS, A
YEAR PLUS TO GET ALL THESE
QUERIES ANSWERED.
AND THEN THE DATA SHARING
INITIATIVES THAT I THINK THEY
ARE OBLIGATED TO DO AND THERE'S
BEEN MULTIPLE PUBLICATIONS AT
clinicaltrials.gov AND PROJECT
DATASPHERE HAVE A LOT OF MISSING
DATA SETS FROM NCCTN TRIALS.
DIFFERENT THINGS REQUIRED IN THE
PROTOCOL, COLLECTED, NOT
UPLOADED.
SO QUALITY, IF YOU ASK ABOUT
QUALITY AND TRACK QUALITY, YOU
KNOW, IN MY VIEW THAT'S THE WAY
TO GET IT.
I'M INTERESTED BECAUSE I CARE
ABOUT EFFECTIVE PARTNERSHIPS.
WE BROUGHT UP BEFORE HOW
BRINGING BEVACIZUMAB --
[AUDIO DISTORTION]
LED TO ONE OF THE BEST FASTEST
ACCRUALS ON RECORD, FROM WHAT I
RECALL, BECAUSE THE INDUSTRY
PEOPLE THAT HAD BEVACIZUMAB
REALLY DID WORK WELL AND
COLLABORATE WELL TO GET THE
QUALITY OUT OF THE
COLLABORATION.
THAT'S MY OWN FEELING.
THANK YOU.
>>I THINK WE'LL TAKE THAT
COMMENT.
I WILL SAY THAT BECAUSE THESE
STUDIES ARE ACTUALLY MONITORED
BY THE SAME ENTITY, I THINK
THERE'S THE OPPORTUNITY TO BE
ABLE TO LOOK AT THE DATA QUALITY
AND TO LOOK AT IT OVER TIME TO
GET A SENSE OF SOME OF THAT SO
WHEN WE THEN MOVE TOWARDS THESE
PRIVATE PARTNERSHIPS THAT WE'VE
GOT SOME DATA IN HAND REGARDING
HOW WELL THE GROUPS ARE DOING IN
CAPTURING ALL THE DATA AND HOW
CLEAN THAT DATA IS, YOU KNOW.
>>THE OTHER THING THAT I --
[AUDIO DISTORTION]
COMPLETERS, WE TALK ABOUT
ACCRUAL OF UNDERSERVED AND
MINORITY, BUT I THINK IT COULD
WELL BE IT'S ONE ON ONE FOR WHO
FINISHES THE STUDY AND PROVIDES
DATA THAT'S MEANINGFUL TO
ANALYZE.
BUT MAYBE IT'S NOT.
AND I THINK, AGAIN, YOU KNOW,
WHAT YOU ASK FOR, WHAT YOU
MEASURE, IS THE BEST WAY TO GET
SOMETHING AND SHOW PEOPLE YOU
VALUE IT.
>>GREAT POINT, HOWARD.
THERE BEING NO OTHER DISCUSSION,
IT'S TIME FOR NCAB TO VOTE TO
ACCEPT THE REPORT.
IS THERE A MOTION TO ACCEPT?
>>SO MOVED.
>>SECOND?
>>SECOND.
>>NOW IT'S BEEN PROPERLY MOVED
AND SECONDED.
QUESTIONS?
LET'S VOTE.
ARE THERE ANY NAYS?
DOES ANYONE NEED TO ABSTAIN?
PAULETTE?
>>IT'S UNANIMOUS VOTE.
>>THANK YOU.
SO MOVING ON, WE HAVE ROUGHLY
TEN MINUTES ON THE FORMAL
AGENDA, MOVING TO OTHER
BUSINESS, THE ANNUAL BSA CONCEPT
REVIEW REPORT IS POSTED ON THE
BSA ONLY WEBSITE.
AND SO THE MEMBERS ONLY WEBSITE.
AS REQUESTED PRIOR YEARS OF THE
REPORT HAVE BEEN ARCHIVED.
SO YOU CAN NOW HAVE ACCESS TO
THOSE TO REVIEW.
I GUESS NOW WE ASK ARE THERE
THOUGHTS, ISSUES, CONCERNS,
RECOMMENDATIONS THAT ANYONE
WOULD LIKE TO SHARE TODAY THAT
THE BOARDS AND NCI SHOULD
CONSIDER GOING FORWARD?
I THINK FOR ME ONE THING IS WE
SHOULD TRY TO ENSURE THAT THE
PRESENTATIONS ALLOW FOR ADEQUATE
TIME FOR DISCUSSION.
I KNOW THERE'S A 30-MINUTE SLOT
SOMETIMES A PRESENTATION WILL GO
25, 28 MINUTES, WE DON'T HAVE
ENOUGH TIME.
I'M NOT QUITE SURE HOW WE DO
THAT BUT IT WOULD BE GOOD IF
DURING THE PLANNING THAT
THERE'S, YOU KNOW, CLEARER
INSTRUCTIONS IN TERMS OF THE
TIME OF THE PRESENTATION VERSUS
DISCUSSION.
THAT'S ONE QUESTION OR COMMENT
THAT I HAD.
MARGARET, I SEE YOUR HAND.
>>THANK YOU.
THIS IS JUST A THOUGHT.
YOU CAN THINK IT'S NOT
APPROPRIATE, BUT I WAS WONDERING
IF WHEN DIVISIONS AND SO ON
PRESENT THEIR REPORTS, WE ALL
KNOW THEY ARE DOING OUTSTANDING
JOBS, HIGHLY PRODUCTIVE, AND I'M
WOUND EARNING IF -- WONDERING IF
THERE SHOULDN'T BE A SMALL
SECTION ON ISSUES, CHALLENGES
THEY ARE FACING AND GAPS AND
WAYS IN WHICH BESIDES JUST
LAUDING THEM FOR THEIR REALLY
GOOD WORK WE CAN ACTUALLY DO
SOMETHING TO HELP THEM.
>>THAT'S A GOOD POINT.
AGAIN, THAT ALSO SPEAKS TO
FRAMING THE PRESENTATIONS
APPROPRIATELY.
>>IN TERMS OF PRESENTATIONS,
THEY ARE GIVE AN SET TIME TO
PRESENT, A SET TIME WHEN FOR
QUESTIONS TO BE CONSIDERED.
IF THE PRESENTERS GO PAST THAT
TIME THERE'S NO CONTROL.
>>I DON'T KNOW IF CAN SEE IF
IT'S 20 AND 10 OR 25 AND 5 TO
KNOW.
I HAVE NO PROBLEMS CUTTING
PEOPLE OFF.
>>I WILL LET THE CHAIR KNOW.
>>THAT WOULD BE GREAT.
THANK YOU, PAULETTE.
THAT'S GREAT.
AND THANK YOU, MARGARET, IN
TERMS OF THE COMMENT ABOUT THEM,
YOU KNOW, TALKING ABOUT
CHALLENGES AND ISSUES AND
BARRIERS TO PROGRESS.
IT'S A GREAT POINT.
FIRST I SAW NELLIE'S HAND.
>>ALONG THOSE LINES, QUICKLY,
HELPFUL TO HAVE THE
PRESENTATIONS BEFOREHAND TO MAKE
NOTES ON THEM.
IF THAT'S REASONABLE, JUST A
THOUGHT.
AND THEN I'M A NEW BSA MEMBER.
>>LET ME RESPOND.
WE DON'T GET THE PRESENTATIONS
UNTIL THE EVENING BEFORE OR DAY
OF THE PRESENTATION.
>>I'M NOT SURPRISED.
>>OKAY.
SO LET'S MOVE ON.
>>A MORE INFORMED DISCUSSION.
>>I GET IT.
>>LET'S MOVE ON.
>>MINE OTHER POINT WAS
SOMETHING I DON'T KNOW WHETHER
WE ARE ALLOWED TO PROPOSE TOPICS
BUT IF WE ARE THEN I WOULD LIKE
TO PUT SOMETHING ON OUR HORIZON
THAT WORRIES ME.
THAT IS THERE'S LIKE THIS --
REQUESTS FROM THE, I DON'T KNOW,
LEGISLATURE ABOUT DATA SHARING
AND IMMEDIATE PUBLICATION OF
RESEARCH THAT MAY BE COMING DOWN
THE PIKE.
AND WHY THAT WORRIES ME AND I
THINK MONICA IS GOING TO GET
ASKED TO DISCUSS THAT WITH THE
LEGISLATOR, IS THAT IF
PUBLICATIONS NEED TO BE
IMMEDIATELY PUBLISHED WHAT WILL
HAPPEN IS THAT A LOT OF JOURNAL
IT'S, THEIR ENTIRE BUSINESS
MODEL IS GONE AND THEY HAVE TO
CHARGE OPEN ACCESS FEES FOR
EVERYBODY WHO IS WORKING FOR THE
NIH.
IF THEY CHARGE OPEN ACCESS FEES
THOSE CAN RANGE BETWEEN $3,000
OR $15,000 OR $20,000, THAT
COMES BACK TO US, P.I.s, AND
IT COMES BACK TO TWO THINGS THAT
WORRY ME SPECIFICALLY.
ONE IS I'M NOT GOING TO ASK MY
UNDERGRAD STUDENT TO WRITE THEIR
OWN PAPER ANYMORE IF IT COSTS ME
$5,000, RIGHT?
SO IT MEANS TRAINEES WILL BE
DISADVANTAGED BECAUSE WE'LL BE
THINKING MORE CAREFULLY ABOUT
HOW MUCH DOES IT COST US TO
PUBLISH AND TRAINEES AND THEY
WILL NOT HAVE FIRST AUTHOR
PUBLICATIONS.
SECOND PROBLEM WITH THIS IF WEEP
IN THE -- IF WE IN THE UNITED
STATES WITH NIH FUNDING HAVE TO
DO THAT BUT LET'S SAY OTHER
COUNTRIES DON'TS HAVE THAT
REQUIREMENT IT PUTS THE U.S.
SCIENTISTS AT A DISADVANTAGE
BECAUSE, AGAIN, WE WILL THINK
TWICE WHEN WE PUBLISH AND WILL
PROBABLY WAIT A LITTLE BIT
LONGER BEFORE SUBMITTING
SOMETHING AND MAYBE CHINA,
JAPAN, WHATEVER, CAN GET THEIR
STUFF OUT.
OF
MAYBE I'M PARANOID, I'M WORRIED
ABOUT THIS BEING SOMETHING THAT
COULD IMPACT US IN VERY
UNEXPECTED WAYS THAT WE DON'T
WANT TO HAVE HAPPEN.
>>THAT'S A FUTURE AGENDA ITEM.
>>YES.
I WAS GOING TO GET TO THAT.
IT'S OKAY.
IT'S OKAY, NELI.
I APPRECIATE THE COMMENTS.
IT'S A REALLY GOOD ONE.
DOUG, I WASN'T SURE IF YOUR HAND
WAS TO RESPOND.
>>YES, I WANTED TO GIVE A BRIEF
PRELIMINARY RESPONSE TO NELI.
NIH LEADERSHIP IS GOING TO BE
MAKING A RESPONSE TO OSTP IN
FEBRUARY.
AND THERE WILL THEN BE ADEQUATE
TIME FOR A RESPONSE.
AND WHAT NIH LEADERSHIP HAS TOLD
ME IS THAT THEY MAKE A
DISTINCTION BETWEEN SOMETHING
BEING PUBLICLY AVAILABLE AND
SOMETHING BEING OPEN ACCESS.
>>VERY GOOD.
ADIN, DO YOU HAVE ADDITIONAL
COMMENTS ABOUT THAT.
>>I WAS GOING TO MAKE THE SAME
COMMENT.
THANKS, JOHN.
>>GREAT.
THANKS.
A GREAT POINT.
SHOULD BE A FUTURE AGENDA ITEM.
>>I JUST HAD A QUESTION ABOUT
IN-PERSON TIME.
>>IN-PERSON TIME?
>>YES, CAN IT BE VIRTUAL
FOREVER?
[LAUGHTER]
>>OKAY, NCAB MEETING IN
FEBRUARY IS VIRTUAL DUE TO THE
WEATHER.
BSA MEETING IN MARCH WILL BE
VIRTUAL.
BUT HOPEFULLY WE CAN MOVE
TOWARDS FACE-TO-FACE IN REGARDS
TO THE JUNE 23 MEETING.
OKAY?
>>GOT IT.
>>I APPRECIATE THAT COMMENT.
I'VE BEEN SNOWED IN MARYLAND FOR
A STUDY SECTION BEFORE.
I GET IT.
OKAY.
GREAT.
NOW WE'RE GOING TO MOVE TO
ACTUAL SUGGESTIONS FOR FUTURE
AGENDA ITEMS.
ONE THAT I MENTIONED WAS NCI
FREDERICK.
ARE THERE OTHER -- NELI PROVIDED
ONE.
ARE THERE OTHERS?
YOUR HAND IS STILL UP.
OKAY.
>>YEAH, THIS IS HOWARD.
WE TALKED ONCE ABOUT GETTING AN
UPDATE ON WHAT'S GOING ON WITH
THE CIMACs AND
IMMUNO-ONCOLOGYP.
[AUDIO DISTORTION]
BEING DEVELOPED.
JOHN, AT THE LAST MEETING YOU
LIKED THAT IDEA GOING FORWARD
BUT THEY ARE STARTING TO
PUBLISH, THREE OR FOUR
PUBLICATIONS HAVE NOW COME OUT
OF THE CIMACs, AND BUT IT'S A
BIT HARD TO DIGEST AND SOMEBODY
LIKE DINAH SINGER, WHO HAS GREAT
PRESENTATION SKILLS, OR SOMEONE,
YOU KNOW, COULD PROBABLY DO A
GREAT JOB SUMMARIZING WHERE
THE --
[AUDIO DISTORTION]
>>I LOVE THAT IDEA.
>>ALSO HOW THESE GRANTS SHOULD
BE GOING THEM, IMMUNO-ONCOLOGY
GRANTS, I'M NOT SEEING THEM
QUOTING OR BUILDING ON THOSE
INVESTMENTS.
>>GREAT POINT.
AND I THINK THAT WOULD BE A
REALLY GOOD FUTURE AGENDA ITEM
FOR BOTH NCAB AND BSA.
KAREN?
>>YEAH, SO ONE IDEA OR
SUGGESTION I WOULD HAVE FOR A
FUTURE MEETING IS SOMETHING
AROUND ALL OF THE CREDIBLE DATA
SHARING POLICIES THAT SEEM TO BE
COMING OUT OF EVERY WHICH WAY WE
TURN AROUND, PARTICULARLY IF YOU
LOOK FOR THE NEW NIH-WIDE
POLICIES THAT WE'RE ALL EXPECTED
TO IMPLEMENT AS OF JANUARY 25
THAT PEOPLE ARE TALKING ABOUT
SETTING UP REPOSITORIES AND
INSTITUTIONS, AND, YOU KNOW,
ACTUALLY EVEN POTENTIALLY HAVING
YOUR DATA BEFORE YOU PUBLISH AN
ARTICLE, THERE'S A LOT OF THINGS
TO INTERPRET IN THESE POLICIES.
AND IT WOULD BE REALLY GREAT TO
HEAR NCI'S PERSPECTIVE ON
POLICIES TO KIND OF THINK ABOUT
WHERE THEY SHOULD BE GOING,
WHERE WE SHOULD BE GOING, THINGS
LIKE THAT.
I JUST THINK IT WOULD BE
INFORMATIVE FOR US TO HEAR,
MAYBE WE CAN HAVE SOME GOOD
INPUT ON ALL OF THIS.
>>GREAT POINT.
AND HOPEFULLY THAT'S NOTED AND
CAPTURED.
IF THERE ARE ANY OTHER TOPICS,
PLEASE FEEL FREE TO SEND THEM
FROM THE JOINT COMMITTEE, FEEL
FREE TO SEND THEM TO KEITH OR
PAULETTE OR MYSELF, INDIVIDUAL
BOARD AGENDA SUGGESTIONS TO
PAULETTE OR THE CHAIR.
I THANK YOU FOR AN AMAZING
MEETING GETTING TO HEAR FROM OUR
NEW NCI DIRECTOR AS WELL AS
INAUGURAL ARPA-H DIRECTOR WAS TO
ME AN ABSOLUTE TREAT.
THE QUESTIONS, COMMENTS,
FEEDBACK WERE INSIGHTFUL OVER
THE LAST COUPLE DAYS.
I THINK NCI IS GOING TO BE
BETTER FROM THESE MEETINGS AND
THESE DISCUSSIONS AND WE'RE ALL
ANXIOUS ABOUT WATCHING OUT FOR
THE BUDGETS AND HOW THAT'S GOING
TO PLAY OUT IN TERMS OF THE C.R.
OVER THE NEXT UPCOMING MONTHS
BUT I FEEL THAT THESE MEETINGS
WERE AMAZING.
KEITH, I DON'T KNOW IF YOU HAVE
FINAL COMMENTS?
>>NO, ECHO THOSE THOUGHTS,
JOHN.
REALLY APPRECIATE THE VIGOROUS
PARTICIPATION OF THE PAST COUPLE
DAYS' DISCUSSIONS.
>>SO THERE BEING NO FURTHER
BUSINESS, WE WILL ADJOURN.
>>HAVE A GREAT HOLIDAY SEASON.
>>AND I'LL SEE THE NCAB MEMBERS
VIRTUALLY IN FEBRUARY.