WE WOULD LIKE TO AGAIN WELCOME
THE MEMBERS OF BOTH THE BOARD OF
SCIENTIFIC ADVISERS AND THE
NATIONAL CANCER ADVISORY BOARD
AND EX-OFFICIO MEMBERS AND
PRESIDENT CANCER PANEL MEMBERS
STAFF AND GUESTS.
TODAY WE HAVE NEW CONCEPTS SO
THERE ARE NO REISSUES EXCEPT FOR
THE PRAIRIE ISSUES AND IN THAT
INSTANCE, THERE WILL BE NO
CONFLICTS SINCE THE VOTE WILL BE
ON BLOCK.
TO OUR EIGHT NEW CONCEPTS THEY
HAVE BEEN ASSIGNED TO REVIEWERS
TO EACH AND DEFER A NEW CONCEPT
AND CONCUR OR NON CONCUR WITH
THE PRAIRIE ISSUES.
MEMBERS MAY PARTICIPATE IN THE
EACH CONCEPT AND ONLY BSA
MEMBERS WILL VOTE.
PLEASE LET'S TROY TO KEEP AN EYE
ON THE CLOCK AND BE MINDFUL OF
THE NUMBER OF CONCEPTS THAT WE
HAVE TO DISCUSS.
IMPORTANT OF COURSE TO RAISE
PRESSING QUESTIONS AND WE ALWAYS
HAVE THE OPPORTUNITY TO DIRECT
QUESTIONS TO PROGRAM OFFICERS
FOLLOWING OUR DISCUSSION AS LONG
AS WE'VE HAD SUFFICIENT
DISCUSSION TO BE ABLE TO HOLD A
VOTE.
AND DURING THE VOTING I WILL ASK
HOW MANY MEMBERS DIS APPROVE
AND.
>> PAUL OUT AND COUNT AND RECORD
THE VOTE.
AS WE'VE DONE IN PRIOR
ENTEROVIENTEROVIRTUALMEETINGS IR
DISAPPROVAL AND CAUSE FOR VERB
USING THE ON-LINE PLATFORM AND
HAND RAISING FUNCTION AND ASK
FOR ABSTENTIONS.
THE FIRST CONCEPT IS
CO-OPERATIVE AGREEMENT.
THE MATAS ADVERTISE RESEARCH
NETWORK AND AND THIS IS A UO1
MECHANISMS AND Dr. JOANNA
WATSON IS PRIOR TO TODAY ARE
DOCTORS CON JOIN US FOR THE
DISCUSSION TODAY BUT WAS PART OF
THE GROUP DISCUSSION IN THE
PREVIOUS INCOMPETENTER ACTION
WITH Dr. WATSON.
Dr. WATSON, GO AHEAD WITH YOUR
PRESENTATION.
>> THANK YOU, VERY MUCH.
GOOD AFTERNOON, I WOULD LIKE TO
START BY THANKING THE BSA
SUBCOMMITTEE FOR THEIR TIME AND
HELPFUL COMMENTS AND THE ENTIRE
BSA COMMITTEE TO PRESENT A
CONCEPT FOR THE MATAS TA
ADVERTISE RESEARCH CONCEPTING
USING THE UO1 MECHANISM AND IT'S
BEING PUT FOURTH BY THE MET MET
PRAG ATTIC TEAM OF CHRISTINE,
BRUNILDE GRILL AND MYSELF.
METNET WAS ESTABLISHED AS A WAY
TO INCENTIVIZE COLLABORATIVE
BASIC RESEARCH AND IT EXPANDS
OUR MECHANIC ADVERTISE TICK AND
BIOLOGICAL CASES TO CONSIDER THE
MECHANISM THE STRUCTURE IS SHOWN
HERE ON THE LEFT, WITH THE
MINIMUM REQUIRED ELEMENTS IN
GREEN.
TO PROMOTE THE USE OF SYSTEMS
LEVEL APPROACHES, EACH CENTER
WAS REQUIRED TO ADDRESS TWO
RESEARCH THEMES THAT SPAN THE
MATAS TA IS CONTINUUM AND
INTERACTION AND CROSS TALK AND
DORMANCY AND RESPONSES TO
THERAPY AND EACH CENTER
PARTICIPATE IN A MONTHLY
STEERING COMMITTEE MEETING AND
RESOURCE AND DATA SHARING
WORKING GROUP AND A PATIENT
ADVOCACY WORKING GROUP.
WE RECEIVED A ROBUST RESPONSE OF
39U54 APPLICATIONS IN RESPONSE
TO THE RFA AND WE'VE BEEN ABLE
TO FUND FOUR CENTERS.
THIS IS A BUSY SLIDE AND I'LL
WALK EVERYBODY THROUGH IT.
THE NAMES OF THE CENTER CONTACT
PIs ARE IN THE CENTER OF THE
CIRCLES.
THESE FOUR SELECTED CENTERS ARE
INTEGRATED ON MULTIPLE LEVELS.
FIRST, THE INTEGRATED THROUGH
SHARED ORGAN OR TISSUE BIOLOGY
WITH THE SOLID CENTER COLORS.
SECOND, THEY'RE INTEGRATED
THROUGH BIOLOGICAL PROCESSES OR
SYSTEMS WHICH IS DENOTED BY THE
OUT OF COLORED RANKS AND THIRD
THE INTEGRATED THROUGH THE
REQUIRED RESEARCH THEMES WHICH
IS DENOTED BY THE SINGLE BOLD
LETTERS.
WE BELIEVE SUCH INTEGRATION
ACROSS MULTIPLE MASS ET CETERA
IS KEY TO DEVELOPING A
SUCCESSFUL NETWORK AS IT
PROVIDES AMPLE MOODS AND
OPPORTUNITIES FOR INTERACTION
AND COLLABORATION TOWARDS THE
GOAL OF GENERATING A MORE
COMPREHENSIVE PICTURE OF
METASTASIS.
ALL FOUR CENTERS EXPLORE
INTERACTIONS AND CROSS WALK
WITHIN THE TUMOR MICRO
ENVIRONMENT.
THREE EXPLORE HOW METASTATIC
CELLS RESPOND TO DIFFERENT
STANDARD OF CARE THERAPIES AND
TWO EXPLORE EARLY DISSEMINATION
OF BREAST OR COLORECTAL CANCER
CELLS YET ONLY ONE TOUCHES ON
THE TOPIC OF DORMANCY.
SO WITH THIS IS BACKGROUND WE
REALIZE THAT THERE ARE IMPORTANT
SCIENTIFIC OPPORTUNITIES IN
METASTASIS THAT COULD STRENGTHEN
THE METNET OVER ALL.
THESE OPPORTUNITIES INCLUDE
STUDIES OF METASTASIS FROM OTHER
PRIMARY SITES SUCH AS THE
PROSTATE OR THE PANCREAS OR
SITES THAT HAVE UNIQUE MICRO
ENVIRONMENTS, PHYSIOLOGY AND
HIGHER INCREASING METASTATIC
RATES.
AND THIS OPPORTUNITIES TO STUDY
METASTASIS TO OTHER SECONDARY
SITES SUCH AS THE BONE OR LUNG.
THESE ARE COMMON SIGHTS BUT
THEY'RE NOT REPRESENTED WITHIN
THE METNET.
DURING OUR DISCUSSION, BSA
SUBCOMMITTEE MEMBER MEMBERS THE
NEED TO UNDERSTAND THE BONE
MATAS SIS AND REALLY ENCOURAGE
THE FOCUS OF CANCER THAT'S
CONTINUE TO BE ASSOCIATED WITH
HIGH OR INCREASING RATES OF
METASTASIS AND MORTALITY.
OBVIOUSLY THERE ARE SOME
ADDITIONAL OPPORTUNITIES THAT
COULD INCLUDE A DEEPER
INVESTIGATION INTO SOME OF THE
OTHER PROCESSES AND SUCH AS HOW
THE NEURO SIGNALING NETWORKS AND
INNOVATION CONTRIBUTE TO
METASTASIS AND WE RECOGNIZE IS
AN IMPORTANT EMERGING AREA IN
CANCER BIOLOGY.
NEXT SLIDE, WE BELIEVE THAT
EMPHASIZING THIS THEME WOULD BE
APPROPRIATE IN THIS CONCEPT.
AND THE BSA SUBCOMMITTEE ASKED
ABOUT THE SIGNIFICANCE OF
FOCUSING ON DORMANCY IT'S A
CRITICAL CONTRIBUTE OR TO
RESISTANCE TO THERAPIES AND
DISEASE RECURRENCE.
MORE OVER, THE STUDY OF DORM
ANNIE WHICH INVOLVES CELL AND
EXTRINSIC AND TRINSIC PROCESSES
LENDS ITSELF WELL TO FULLY
DEFINE THE MECHANISMS INVOLVED.
THUS, WE REALLY THINK THE METNET
WOULD BE STRENGTHED BY PROVIDING
OPPORTUNITIES OR A CONCERTED
EFFORT IN THIS AREA.
FOR EXAMPLE, WE KNOW THAT
DIFFERENT BREAST CANCER SUB
TYPES METASTASIZE TO DIFFERENT
SYSTEMS AND WHAT IS THE
MECHANISM THAT'S DRIVE THESE
DETERMINE ANNIE AND IT'S
IMPORTANT TO STUDY MECHANISMS
ASSOCIATED WITH ESTABLISHING
MAINTAINING OR EMERGING FROM A
DETERMINDORMANT STATE AND NEXT .
WE WOULD LIKE TO PROPOSE TO
STRATEGICALLY BUILD OUT AND
STRENGTHEN THE METNET.
BUILDING ON THE MOMENTUM AND THE
INTEREST IN USING SYSTEMS LEVEL
APPROACHES TO ADDRESS CRITICAL
QUESTIONS IN MATAS TA ADVERTISE
AS EVIDENCE BY THE CONTINUED
INTEREST IN THE RFA, EVEN THOUGH
IT'S EXPIRED.
I WOULD ALSO LIKE TO POINT OUT
THAT DURING THE REVIEW OF THE
U54 APPLICATIONS, EVEN AMONG THE
CENTER APPLICATIONS THAT WERE
NOT SELECTED FOR FUNDING
CONSIDERATION, MANY OF THE
INDIVIDUAL PROJECTS WERE
ENTHUSIASTICALLY RECEIVED AND
SOME OF THESE FOCUSED ON BONE
METASTASIS OR DORMANCY.
U01 MECHANISM MAY ENCOURAGE
SUBMISSION OF THESE PROJECTION,
PARTICULARLY THOSE THAT WOULD
ADDRESS THE OPPORTUNITY BARRIERS
WE IDENTIFIED IN THE CONCEPTS.
TO GIVE YOU AN IDEA OF THE
PORTFOLIO AND THE AREAS OF
METASTASIS, DORMANCY AND SYSTEMS
APPROACHES WE USED TWO METHODS.
A HERCULEAN EFFORT AND MANUALLY
CURATED THE ENTIRE PORTFOLIO OF
MORE THAN 300 AWARDS AND WE ALSO
DOUG A SEARCH OF ABSTRACT AND
SEC SPECIFIC AIMS USING KEY WORS
AND COMPOUND PHRASING.
THE AWARDS MAKE UP 3% OF THE
BRANCH PORTFOLIO AND 6% OF THE
NCI COMPETING PORTFOLIO.
AND THE BSA SUBCOMMITTEE
QUESTIONED WHY WE THOUGHT THIS
NUMBER WAS SO LOW.
AND THE UNDERSTANDING LOW
REPRESENTATION IN THE PORTFOLIO
IS NEVER A SIMPLE TASK AND NONE
THE LESS, WE ACKNOWLEDGE THAT
THERE'S WILL BE RECENT PROGRESS
IN OVERCOMING TECHNICAL
CHALLENGE THAT'S HAVE PREVIOUSLY
LIMITED STUDIES IN DETERMINE
ANTSY.
IN MY DISCUSSION, SHE SAID HER
COLLEAGUES HAVE A DIFFICULT TIME
GETTING WILL APPLICATIONS
THROUGH PEER REVIEW AND SO THAT
CAN BE ONE REASON.
MY BRANCH NUMBERS ARE ACCURATE
AND THE NCI PORTFOLIO NUMBERS
AND UNDERESTIMATE THE TOTAL
DORMANCY BECAUSE THE WAY THE
SEARCH WAS DONE REQUIRING BOTH
METASTASIS AND DETERMINE ANTSY
TERMS AND SOME FOCUS ON
REACTIVATION RATHER THAN
DORMANCY AND OTHERS EXPLORE IN
THE CONTEXT OF THE PRIMARY TUMOR
OR RESPONSE TO THERAPY AND
WITHOUT NECESSARILY CONSIDERING
METASTASIS.
REGARDLESS, I THINK EVEN
CONSIDERING SUCH GRANTS THE SIZE
OF THE PORTFOLIO IS NOT
DRAMATICALLY AND I BELIEVE THAT
THIS REFLECTS THE OVER ALL SMALL
SIZE OF THE DORMANCY COMMUNITY.
THE OTHER ASPECT IS THE SYSTEMS
APPROACHES AND WITHIN THE TM
PORTFOLIO, THIS IS STUDIES THAT
LOOK AT SYSTEMIC EFFECTS OF
CANCER AND FOUR TO FIVE% FIVE PT
OF THE AWARDS.
THE TERMS OF SYSTEMS BIOLOGY
IDENTIFIED SIX AWARDS AND THOSE
MOST WERE ASSOCIATED WITH THE
CANCER SYSTEMS BIOLOGY
CONSORTIUM.
SO WE'RE PROPOSING THE
APPLICATIONS AT THE FOLLOWING
REQUIREMENTS.
THEY MUST APPLY SYSTEMS LEVEL
APPROACHES TO ADDRESS ONE OF THE
ORIGINAL METNET FOA THEMES
ENSURING INTEGRATION TO THE
CURRENT METNET CENTERS AND THE
APPLICANTS MUST DESIGNATE A
RESOURCE AND DATA SHARING
MANAGER AND AN ADMINISTRATIVE
MANAGER TO FACILITATE SHARING OF
RESOURCES AND DATA AND GENERAL
COMMUNITY INDICATIONS
RESPECTIVELY.
THE RESOURCE AND DATA SHARING
MANAGER WILL BE CRITICAL AS THE
NEW POLICY ON DATA SHARING GOES
INTO EFFECT NEXT YEAR AND WE
WOULD ALSO ASK THE APPLICANTS
HAVE A SMALL SET ASIDE FOR PILOT
PROJECTS AND AT LEAST 25,000 IN
OUT YEARS TO FACILITATE THE
INTRANET WORK COLLABORATIONS.
AT THE RECOMMENDATION OF THE BSA
SUBCOMMITTEE WE WILL PLACE
EMPHASIS ON UNDERSTANDING
MECHANISMS OF METASTASIS ACROSS
DIVERSE PATIENT POPULATIONS.
SO THERE ARE BENEFITS TO USING
THE CO-OPERATIVE AGREEMENT.
IT WOULD HELP ALIGN THE RESEARCH
PROJECTS AND INVESTIGATORS WITH
THE RESPONSIBILITIES AND CONDUCT
GUIDELINES THAT WE'VE ALREADY
OUTLINED AND SET FOR THE U54
CENTERS SO WE WOULD BE CREATING
A LEVEL PLAYING FIELD.
AND A CO-OPERATIVE AGREEMENT
WILL PERMIT ENFORCING AS MUCH AS
WE CAN, AND THE PARTICIPATION
REQUIREMENTS IN THE STEERING
COMMITTEE AND THE RESOURCE AND
DATA SHARING WORKING GROUPS AND
THE CO-OPERATIVE AGREEMENTS
WHICH REQUIRE SUBSTANTIVE
PROGRAM INVOLVEMENT HELPING IN
FACILITATING SOME INTRANET WORK
COLLABORATION AND COMMUNICATION
AND FACILITATING EXCESS TO OTHER
RESOURCE AND PROGRAMS AND HELP
WITH COMMUNICATION FOR THE INTRA
DISCIPLINARY TEAMS.
WE PROPOSED THAT THIS CONCEPT
STOBBE ISSUED AS A PAK FOR
APPLICATIONS AND WE DON'T
REQUEST ANY SET ASIDE THESE
APPLICATIONS WILL BE INTER DIS
MINNAAR' REQUIRE A REVIEW LOCUS
WE WOULD LIKE TWO RECEIPT DAYS
FOR THREE YEARS AND WE WOULD
ANTICIPATE TWO TO THREE
APPLICATIONS SELECTED FOR
FUNDING CONSIDERATION EACH ROUND
AND THIS WOULD BE BASED ON
PRIORITIES AND THAT ARE GOING TO
FIT WITHIN THE MET NET AND
AVAILABLE FUNDING AND IMPACT
SCORE AND THE SUBCOMMITTEE
ACQUIRED BUDGETS WHICH WOULD BE
FROM THE RANGE OF A LARGE RO1
BUT KEPT AT A REQUEST OF
$500,000 PER YEAR IN DIRECT
COSTS, NEXT SLIDE.
THIS IS MY FINE A SLIDE JUST TO
OUTLINE THE GOAL OF THE CONCEPT
WHICH IS TO ADD UR1 RESEARCH
PROJECTS AND SYSTEMS LEVEL THE
RESEARCH NETWORK SO THANK YOU
FOR YOUR ATTENTION AND I'M VERY
HAPPY TO TAKE ANY QUESTIONS.
>> SO, THANK YOU Dr. WATSON
AND YOUR TEAM FOR GREAT
PRESENTATION AND ALSO FOR BEING
SO RESPONSIVE TO THAT COMMENTS
AND QUERY.
AS WAS NOTED, THE SUBCOMMITTEE
MEMBERS MET WITH Dr. WATSON
AND HER COLLEAGUES IN TWO
PARALLEL MEETINGS TO DISCUSS THE
METASTASIS PROPOSAL THAT WAS
NICELY PRESENTED AND AS WE HEARD
THIS PROPOSAL SPECIFICS PANS OF
A EXITING METNET FRAMEWORK WITH
THE GOAL OF REALLY CREATING A
MORE COMPREHENSIVE PICTURE OF
DISEASE USING A BIOLOGY APPROACH
AND I WOULD SAY THE SUBCOMMITTEE
WAS UNANIMOUS AND IT'S VERY
STRONG SUPPORT FOR IT PROPOSAL,
WE WILL ACKNOWLEDGE THAT THE
METNET PROGRAM IS NEW AND IT'S
NOT POSSIBLE TO HAVE A SORT OF
COMPREHENSIVE EVALUATION OF THE
PROGRAM TO DATE AND THIS MIGHT
BE SOMETHING THAT OTHERS IN THIS
GROUP MIGHT QUESTION BUT
NEVERTHELESS, THE SUBCOMMITTEE
IDENTIFIED A NUMBER OF REASONS
FOR STRONG SUPPORT FOR THE
PROPOSAL AND OF COURSE, STARTING
WITH THE FACT THERE'S A STRONG
SCIENTIFIC RATIONALE TO EXPAND
WORK IN THIS AREA GIVEN THE
METASTATIC DISEASE IN POOR
TENDING, POOR PATIENT OUTCOMES
AND I THINK WE ALSO REALLY
APPRECIATED THAT THERE'S A
STRONG INTEREST IN THIS AREA.
WE WERE INSTRUCT BY THE FACT THE
INITIAL METNET ISSUED IN MAY OF
2020 RESULTED IN 39U54
APPLICATIONS OVER TWO RECEIPT
DATES WITH FOUR OF THOSE
ACTUALLY BEING FUND SOD THERE
ARE A LOT OF REALLY STRONG
PROJECTS AND PENT UP DEMAND FOR
RESEARCH FUNDING IN THIS AREA.
WE ALSO APPRECIATED, AS WAS
HIGHLIGHTED BY Dr. WATSON,
THAT MANY OF THE AREAS IN THE
INITIAL CALL FOR APPLICATIONS
DID GET REPRESENTED IN THE CORE
U54s THAT HAVE BEEN FUNDED BUT
DORMANCY WAS UNDER REPRESENTED
AND REMAINS IN THE PORTFOLIO
ANALYSIS AN AREA THAT IS UNDER
REPRESENTED AND I THINK Dr.
WATSON DID A REALLY NICE JOB OF
ARTICULATING WHY IT'S A
IMPORTANT AREA FOR FURTHER
RESEARCH AND ALSO ARTICULATING
SOME CONFIDENCE THEY ARE ARE
PROJECTS AND WE HEAD IT FROM THE
BSA SUBCOMMITTEE.
WE HAD A ROBUST DISCUSSION AND
WE REALIZED A FEW QUESTIONS AND
MADE SOME MINOR SUGGESTIONS FOR
IMPROVEMENT ALL OF WHICH HAVE
BEEN FULLY ADDRESSED AS WAS
OUTLINED IN THE REPORT.
WE ALSO REQUESTED A COUPLE OF
CHANGES THAT WERE ADOPTED IN THE
CURRENT PROPOSAL INCLUDING A
REQUEST TO EXPAND THE COAST OF
EMPHASIS FOR CANCER THAT'S HAVE
RISING MORTALITY RATES AND IT'S
BEEN INCORPORATED TO ENCOURAGE
APPLICATIONS AND AREAS THAT HAVE
BEEN DIFFICULT TO TREAT SUCH AS
METASTASIS TO BONE AND IT'S BEEN
INCORPORATED TO ENCOURAGE THE
STUDY OF DIVERSE POPULATIONS AND
ENCOURAGE APPLICATIONS FROM JUNE
INVESTIGATORS ALL OF WHICH HAVE
BEEN NOW HIGHLIGHTED IN THE
UPDATED PROPOSAL.
SO, WITH THAT I'LL JUST SAY
VERY, VERY STRONG SUPPORT FROM
THE SUBCOMMITTEE AND SEE IF
Dr. WANTS TO MAKE ANY
ADDITIONAL COMMENTS.
>> THANK YOU, SO, I HAVE VERY
LITTLE TO ADD.
I THINK THE ONE THING I'D LIKE
TO EMPHASIS IS JUST THAT DURING
THE INITIAL COMPETITION, THERE
WERE SO MANY APPLICATIONS
RECEIVED.
I THINK THAT RALLY JUSTIFY THE
NECESSITY TO EXPAND, LIKE
ALWAYS, WE DON'T FUND ENOUGH AND
THIS ONE WAS CLEARLY AN AREA
GROWING A LOT OF CENTER AND IT
WOULD BE GREAT TO GO BACK INTO
THE POOL AND ADD TO WHAT IS
GOING ON.
VERY LITTLE TO ADD OTHER THAN I
THINK GIVING IT MY FULL SUPPORT
FOR THIS.
>> ANY QUESTIONS OR COMMENTS?
>> I WANT TO CONGRATULATE YOU ON
A QUICKLY IMPORTANT AREA OF
RESEARCH AND THE FACT YOU ARE
MAKING THE AWARD WORTH IT TO
APPLY FOR BECAUSE I'VE SEEN SOME
OF THESE INITIATIVES WHERE YOU
KNOW THEY WERE MAYBE LIKE 75K
FOR THREE YEARS AND WHICH WAS
NOT A LOT OF INCENTIVE FOR
PEOPLE WHO ARE WORKING HARD IN
THIS AREA SO CONGRATULATIONS ON
ALL OF THAT.
>> THANK YOU, VERY MUCH.
>> YOUR HAND IS UP.
STILL MUTED.
>> I HAVE A QUESTION AND A
COMMENT.
I WAS JUST CURIOUS AS TO WHAT IS
THE CORE WAS INTENDED TO DO AND
A LOT OF THESE GET TAGGED ON FOR
YOUR U01 MECHANISMS AND I'M
CURIOUS ABOUT THAT AND ALSO THEY
TALKED ABOUT THE DIVERSE AND AND
IT WILL BE INTERESTING TO HAVE A
CONVERSATION OR SO BUT TO
UNDERSTAND WHAT IT ACTUALLY
MEANS.
AGAIN, THESE THINGS GET TAGGED
ON AND IT IS A VISION ON OUT
COME THAT IS DESIGNED TO BE
ACCOMPLISHED AS PART OF THESE
APPLICATIONS SO I'M JUST CURIOUS
ABOUT THOSE.
>> I'M SORRY, I MISSED THE FIRST
PART OF YOUR QUESTION IN TERMS
OF THE ADMINISTRATIVE CORE OR
THE RESOURCE?
>> I'M NOT SURE IF MY WORDS ARE
COMING THROUGH DIRECTLY.
WHAT DIVERSE COMPONENTS OF THE
APPLICATION IS SUPPOSED TO BE
ACCOMPLISHING.
>> SO, FOR THE U01 THERE WOULD
BE A DESIGNATED RESOURCE AND
DATA SHARING MANAGER AND IT'S
BECAUSE CURRENTLY, WE DO NOT
HAVE A COORDINATING CENTER THAT
COORDINATES ALL OF THESE THINGS
AND SO BY HAVING A VERY
SPECIFIED PERSON WHO IS
RESPONSIBLE, THAT ALLOWS THAT
DISCUSSION THE SYNCHRONIZATION
OF THE TYPES OF DATA, HOW IT'S
GOING TO BE SHARED ACROSS THE
NETWORK.
SO THAT PROVIDES THAT.
IN TERMS OF DIVERSE POPULATIONS,
IT IS VERY MUCH A FUNCTION OF IF
SOMEONE WAS GOING TO PROPOSE
THEY WANTED TO LOOK AT
METASTATIC PROSTATE CANCER THAT
THE SAMPLES THEY'RE USING ARE
GOING TO BE REPRESENTATIVE OF
WHAT IS SEEN IN A CLINICAL
PRACTICE.
>> I DON'T SEE ANY OTHER HANDS
SO WE CAN MOVE TO VOTING.
THE DISCUSSION DOES NOT SEEM TO
BE HEADING IN THE DIRECTION
WHERE DEFERRAL IS ON THE TABLE
SO WE'RE GOING TO LOOK FOR
APPROVAL OR DISAPPROVAL VOTES.
WOULD YOU LIKE TO MAKE A MOTION.
>> I MOVE TO APPROVE THIS
PROPOSAL.
>> CAN I HAVE A SECOND.
>> SECOND.
>> THANK YOU.
ANY FURTHER DISCUSSION?
>> JUST A SIDE BAR COMMENT SINCE
I SECONDED.
THIS IS A AN EXTREME AN EXTREMED
CRITICAL AND UNDERFUNDED IN THE
NCI'S PORTFOLIO.
>> NOTED.
>> OK.
WE'LL TAKE A FINAL VOTE NOW.
LOOKING FOR DISAPPROVAL VOTES.
THE MOTION IS FOR APPROVAL.
EITHER VOICE YOUR DISAPPROVAL
VOTE OR RAISE YOUR HAND.
LOOKING ACROSS THREE SCREENS
HERE.
I DON'T SEE ANY.
>> IT'S UNANIMOUS APPROVAL.
>> NO ABSTENTIONS?
JUST MAKING SURE.
I DON'T HAVE ANY PRE SUBMITTED.
GREAT.
OK.
FANTASTIC.
MOVING ALONG.
THE NEXT IS NEW CONCEPT AND NEW
RFA AND BASIC/TRANSLATIONAL
RESEARCH ON HEALTH DISPARITIES
ON HIV/AIDS AND CANCER.
Dr. BETSY READ-CONNOLE IS
PRESENTING AND THE SUBCOMMITTEES
ARE Dr. QU --
>> THANK YOU FOR LISTENING TO
OUR IDEAS FOR A NEW CONCEPT ON
BASIC TRANSLATIONAL RESEARCH ON
HEALTH DISPARITIES IN HIV/AIDS
AND CANCER.
WITH A CLINICAL TRIAL OPTION.
I'M BETSY READ-CONNOLE AND I'M
JOINED BY MY COLLEAGUES Dr.
TIFFANY WALLACE FROM THE CENTER
TO REDUCE CANCER HEALTH
DISPARITIES AND MY COLLEAGUES
FROM THE OFFICE OF HIV AND AIDS
MALIGNANCY.
NEXT SLIDE, PLEASE.
FIRST, I WOULD LIKE TO THANK MY
THREE BSA REVIEWS FOR THEIR
HELPFUL AND THOUGHTFUL
SUGGESTION AND I'VE TRIED TO
EITHER INCORPORATE THEIR
SUGGESTIONS INTO THE SLIDES OR
THEY WILL BE VERBALLY EXPRESSED
DURING THE ORAL PRESENTATION.
IN THE WAY OF THE PURPOSE FOR
THE RFA IS A FOCUS ON THE
BIOLOGICAL INTERACTIONS OF
CANCER HEALTH DISPARITIES IN
LARGE POPULATIONS.
WITH AN UNDERLINE HIV AIDS
INFECTION.
THROUGH BASIC MECHANISTIC
TRANSLATIONAL STUD EYES TO
INVESTIGATE HOW LIVE INTERACTS
WITH THE DISPARITIES TO PROMOTE
THE NON AIDS AND AIDS DEFINING
CANCER INITIATION PROGRESSION
AND THE RESULTING PATHOGENIC
DISEASE SEE QUELL A.
AS A WAY OF THE BACKGROUND, SUCH
AS BLACK, AMERICAN, LATINX
COMMUNITIES, WOMEN OF COLOR,
PEOPLE WHO INJECT DRUGS, MEN WHO
HAVE SEX WITH MEN AND
TRANSGENDER PERSONS.
AND PERSONS WITH CANCER AND NIH
ARE AMPLIFIED IN CERTAIN RACIAL
AND ETHNIC POPULATIONS, LOW
SOCIOECONOMIC GROUPS, PEOPLE
LIVING IN GEOGRAPHICALLY
ISOLATED AREAS AND PEOPLE WITH
LIMITED ACCESS TO PROVEN
SCREENING AND TEST AND HIGHER
RATES OF ADVANCED CANCER
DIAGNOSIS.
THESE ARE PARTIALLY DRIVEN BY
HEALTHCARE PROVIDERS, SHORTAGES,
LOW HEALTH LIT ARE ER LITERACY.
THE MOST PREVALENT IN THE U.S.
POPULATION AMONG PERSONS LIVING
WITH HIV ARE NON HODGKINS LIMB
NOAM A, ANNAL AND LUNG CANCER
AND THE IDEA FOR THIS RFA ON
HEALTH DISPARITIES HIV AND
CANCER, WAS ENDORSED BY THE
HIV/AIDS MALIGNANCY BSA AD HOC
SUBCOMMITTEE AND I WOULD ALSO
MENTION THAT IN DECEMBER OF
2019, THE CANCER TO -- THE
CENTER TO REDUCE CANCER HEALTH
DISPARITIES HELD A NICE WORKSHOP
ON HEALTH DISPARITIES AND CANCER
AND I WAS QUITE STRUCK BY THE
FACT THERE WAS NO INCLUDED HIV
AND CANCER RESEARCH IN THEIR
PRESENTATIONS AND SO I
APPROACHED Dr. SPRINGFIELD AND
HER PROGRAM PAPAL AND SAID YOU
KNOW I THINK WE SHOULD DO
SOMETHING ABOUT THIS TO MAYBE
JUMP START THE FIELD A LITTLE
BIT BECAUSE WE KNOW THIS IS A
DRASTIC NEED.
AND IN THE WAY OF -- NEXT SLIDE
PLEASE.
LOOKING AT POTENTIAL BIOLOGICAL
DIFFERENCES IN DISEASES WITHOUT
AN UNDERLYING HIV INFECTION, IN
A REPORT ANALYZING SIGH TOLL GEE
CASES, FILES FOR AFRICAN
AMERICAN AND CAUCASIAN WOMEN, TY
WERE FOUND IN AFRICAN AMERICAN
WOMEN COMPARED TO CAUCASIAN
WOMEN.
AND ANOTHER LARGE STUDY LOOKED
AT THE IMMUNE PROFILES OF
EUROPEANS AND AFRICANS IN
RESPONSE TO BACTERIAL AND VIRAL
INFLUENZA INFECTIONS.
AND STRONG DIFFERENCES WERE
FOUND THAT PREDOMINANTLY
INFECTED THE ANTI VIRAL AND
INFLAMMATION GENES AND DIFFER IN
RESPONSIVENESS BETWEEN AFRICANS
AND EUROPEANS.
AND IN THE NEXT SLIDE, I SHOW A
STUDY RELATED TO THE FORM OF
CANCER AMONG THE HIV POSITIVE
POPULATION WHICH IS KAPOSI
SARCOMA AND THIS IS THE HAZARD
RATIO FOR AFRICAN AMERICANS IS
STATISTICALLY SIGNIFICANTLY
INCREASING ABOVE THAT OF WHITE
OR CAUCASIAN AMERICANS AND ALL
OTHERS.
WHEN YOU LOOK AT THE RIGHT-HAND
PANEL YOU SEE THE SURVIVAL RATE
IS MUCH PEER ARE FOR THOSE
LIVING IN THE SOUTH COMPARED TO
THE DASH LINE SLIGHTLY ABOVE
THAT.
SEEING THESE BIOLOGICAL
DIFFERENCES, WHAT ARE WAYS THAT
WE CAN ACTUALLY ADDRESS THIS?
SO, WE TURNED TO A PORTFOLIO
ANALYSIS SHOWN ON THE NEXT
SLIDE.
BETWEEN FY2018 AND 2022 LOOKING
FOR HEALTH DISPARITIES, HIV, AND
CANCER, WE FOUND A TOTAL OF SIX
GRANTS IN THE NCI PORTFOLIO.
AND I MAY ALSO POINT OUT THAT
THESE WERE -- FOUR OF THESE
GRANTS WERE IN RESPONSE TO
RFAs AND THAT NCI HAD PUT
FORWARD AND TWO ADDITIONAL ONES
PUT FORWARD.
IF WE LOOK AT THE OTHER
INSTITUTES WITHIN THE NIH, THERE
ARE PROJECTS FUNDED BY NIAID AND
WEST INRELATED TONING THE HIV EC
AND THEY HAVE HEALTH DISPARITIES
IN NIH RESEARCH BUT NOTHING
RELATED TO CANCER.
AS A RESULT OF THIS PORTFOLIO
ANALYSIS, AND PUTTING OUR HEADS
TOGETHER, WE CAME WITH
SUGGESTIONS OF THE FOLLOWING
RESEARCH TOPIC AREAS.
THESE ARE NOT INCLUSIVE BUT OUR
SUGGESTIONS AND THE SUDDEN HE'S
OF HOW WE INTERACT AND GENETIC
DEPOSIT' GENETIC CANCER
SUSCEPTIBLE DIFFERENCE AND
RESPONSES TO CANCER AND THE
MICRO ENVIRONMENT OR TUMOR AND
MICRO AND ANALYSIS AND AS WELL
AS STUDIES THAT INVESTIGATE THE
ROLE OF CO INFECTIONS AND KAPOSI
SARCOMA AND HEPATITIS B AND
HEPATITIS C VIRUSES AND CON
CANCER AND OUTCOMES IN
MARGINALIZED POPULATIONS AND
THAT HAVE THE HEALTH DISPARITIES
AND ARE SEVERELY AND DIS POURS
ATLY EFFECTED BY HIV.
I WOULD ALSO MAKE A NOTE WITHIN
MY DISCUSSIONS WITH THE BSA
REVIEWERS THEY THOUGHT THIS WAS
QUITE -- THIS WAS A INDICT BROAD
AND I EXPLAINED TO THEM THAT
UNFORTUNATELY THE HIV AND CANCER
NUMBER OF INVESTIGATORS IS NOT
THAT LARGE AND IF WE WIDDLE
THINGS DOWN AND WE ARE NOT GOING
TO RECEIVE SUFFICIENT
APPLICATIONS IN RESPONSE TO OUR
RFA.
I WOULD ALSO MAKE A NOTE THAT
SOCIAL DETERMINANTS OF HEALTH
ARE NOT PART OF THIS SPECIFIC
INITIATIVE AND THEY WILL BE
VIEWED AS OUT OF SCOPE AND THAT
ACCEPTED FOR REVIEW AND THAT
SOCIAL DETERMINANTS OF HEALTH
WILL YOU COVERED IN A CONCEPT
THAT IS BEING DEVELOPED BY CRCHD
AND -- SO OUR JUSTIFICATION FOR
THE USE OF AN RFA WAS A
NECESSARY MECHANISM TO
INCENTIVIZE INVESTIGATORS TO
JUMP START THE FIELD OF HEALTH
DISPARITIES WITH AN HIV
INFECTION AND I WILL MENTION DEN
THAT IT WAS ENDORSED AS AN IDEA
BY THE BSA AD HOC SUB COMMITTED
TO THE OFFICE OF HIV RESEARCH
AND FOR FY23 AND IT WAS APPROVED
BY THE OAR AND MARCH OF 24 OF
THIS YEAR.
THE APPLICATIONS WILL BE THEY
WILL REQUIRE EXPERTISE AND LIKE
COMMUNITY ENGAGEMENT GOING ON
THROUGHOUT NIH.
NEXT SLIDE, PLEASE.
SO, OUR EVALUATION PIECE FOR
THIS RFA, SO, FIRST OF ALL, THE
SCIENTIFIC STAFF LISTED ON THE
FIRST SLIDE AND WE WILL CONVENE
AND TRACK THE APPLICATION 0
RECEIPT FUNDING PLAN APPROVAL
AND CLOSE OUT AND WE'LL DESCRIBE
THE PROGRESS AND ACCOMPLISHMENTS
AND ADVANCEMENT ANNOUNCEMENTS
AND TRACK THE NUMBER OF IMPACT
FACTORS OF PUBLICATIONS.
AS WELL, I THINK WE'LL ALSO
FOLLOW THE PROGRESS OF
DEVELOPMENTS LIKE ANTIBODIES
INTRODUCED, ORGANOIDS, MOLECULAR
CON TRUCKS AND THEY WILL BE
AVAILABLE TO THE RESEARCH
COMMUNITY FOR FUTURE STUDIES ON
HEALTH DISPARITIES, CANCER AND
HIV.
AND I WOULD ALSO MENTION THAT WE
AS PROGRAM STAFF CAN CERTAINLY
BE STRONG ADVOCATES TO HELP THE
RESEARCH COMMUNITY ON MAKING
THEM AWARE OF THESE NEW TOOLS
THAT ARE HOPEFULLY WILL BE
AVAILABLE.
WE WILL ALSO SERVE ADDITIONAL
JUDGES.
AND FINALLY ON THE
ADMINISTRATIVE SIDE, WE ARE
PROPOSING RO1s FOR FIVE YEARS
AND R21s FOR TWO YEARS AND WE
HAVE ANTICIPATED RECEIPT DATES
AND WE ARE REQUESTING TWO AND
DECEMBER 2022 AND DECEMBER OF
2023 AND WE ANTICIPATE FUNDING
SEVEN TO EIGHT RO1s AND FIVE
TO SIX R21 APPLICATIONS FOR TWO
YEARS AND OR FIVE YEARS OR TWO
YEARS AND WE HAVE TO FUND IN
JULY OF 2023 AND JULY OF 2024
AND THE SET ASIDE IS COMING FROM
DOLLARS FOR APPLICATIONS THAT
MEET THE LAR PRIORITY GUIDELINES
AND THE FIRST YEAR BUDGET TOTAL
IS FIVE MILLION DOLLARS AND THE
TOTAL PROJECT PERIOD FOR THE TWO
RECEIPT DATES IS A TOTAL OF
$50 MILLION TOTAL COST.
THAT IS MY LAST SLIDE AND I'M
HAPPY TO TAKE ANY QUESTIONS
ANYONE MAY HAVE.
THANK YOU FOR YOUR ATTENTION.
>> GREAT.
THANK YOU.
MY WANT TO OPEN UP THE
DISCUSSION.
>> SOUNDS GREAT.
I WANT TO START BY THANKING YOU
FOR SUCH AN EXCELLENT
PRESENTATION AND I WANT TO THANK
MY COLLEAGUES WHO SERVED ON THE
SUBCOMMITTEE FOR THEIR EXCELLENT
COMMENTS.
SO OUR SUBCOMMITTEE MET ONE TIME
AND MY COLLEAGUES ALSO SUBMITTED
WRITTEN FRONTS ON THIS RFA.
THERE WAS UNANIMOUS SUPPORT FOR
THIS PROGRAM.
IT'S NOTABLE THIS CAME OUT OF A
BSA SUBCOMMITTEE AND THERE'S A
SPECIFIC EMPHASIS ON HEALTH
DISPARITIES AMONG PATIENTS WHO
ARE HIV POSITIVE AND LOOKING AT
CANCER OUTCOMES IN THAT GROUP
AND THE FOCUS OF THIS RFA AS
MENTIONED BY Dr. READ-CONNOLE
IS ON THE RESEARCH AND THE RFA
WILL SUPPORT R01 AND R21
APPLICANTS AND THE SPECIFIC
FOCUS HAS BEEN WELL CLARIFIED
AND YOU KNOW, FOCUSING ON THE
CAUSES, GENETIC ASPECT AND
MICROBIOME AND THE MEASURES OF
SUCCESS ENCLOUD TRADITIONAL
MEASURES OF IMPACT AND
PUBLICATIONS AS WELL AS THE
SCHOOLS DEVELOPED FROM THE
TRANCATTRANCATIONAL RESEARCH.
THE COMMENTS HAVE BEEN WELL
ADDRESS BY THE TEAM AND THOSE
COMMENTS RELATED TO SPECIFY WHY
THE SOCIAL DETERMINANTS OF
HEALTH WOULD NOT BE COVERED IN
THIS APPLICATION AND I THINK
THAT WAS WELL DESCRIBED IN HER
PRESENTATION AND SPECIFYING MORE
CLEARLY THIS SUCCESS METRICS AND
SPECIFYING THE DISPARITY SO I
THINK THE POPULATION HAVE BEEN
WELL DESCRIBED INCLUDING THOSE
POPULATIONS THAT HAVE A HIGHER
INSTANCE OF HIV INFECTION AND
INCLUDING BLACKS, HISPANICS,
DRUG USERS AND AND THERE WAS A
SUGGESTION TO EXPAND THE METRICS
FOR SUCCESS AS WELL AND THOSE
HAVE BEEN WELL DESCRIBED IN THE
PRESENTATION.
SO JUST A RECAP, THIS AGAIN HAS
BEEN WELL ENDORSED AS IT CAME
FROM THE BSA SUBCOMMITTEE AND AS
Dr. READ-CONNOLE MENTIONED
IT'S BEEN APPROVED BY THE OFFICE
OF RESEARCH AND FUNDING IS
AVAILABLE FOR THIS PARTICULAR
RFA.
>> GREAT.
THANK YOU.
MICHELLE.
>> I WANT TO ADD, I THINK OUR
SENTIMENT IS VERY WELL BUT I WAS
STRUCK IN ADDITION TO THE NEED
TO STUDY HEALTH DISPARITIES
ASPECT OF AIDS ASSOCIATED IN
CANCER AND IT REALLY RESINATED
WITH ME THAT RESPECT FROM THE
CANCER HAS CHANGED OVER THE LAST
FEW DECADES WITH AGING OF THE
POPULATION AND CONTEMPORARY
THERAPY AND I KNOW LITTLE ABOUT
THE IDEOLOGY OF THE NEW CANCER
AND AS WELL AS THE GOAL OF HIV
AND VIRUSES ASSOCIATE INSIDE
THIS PROCESS SO THIS IS VERY
TIMELY.
>> I DON'T HAVE ANYTHING TO ADD.
>> GREAT.
>> OTHER MEMBERS, DO YOU HAVE
ANY COMMENTS OR QUESTIONS?
>> A COUPLE.
ONE IS A QUESTION.
WHAT ABOUT THE INCLUSION OF
COHORTS FROM SUB ZAHAR ANT
AFRICA OR OTHER PLACES, IT
WASN'T CLEAR WHETHER THOSE WOULD
BE ALLOWABLE.
>> YES, VERY MUCH WE WILL
ENCLOUD THOSE AND WE ALSO KNOW
MANY OF THE INVESTIGATORS THAT
ARE IN THE FIELD OF HIV AND
CANCER DO HAVE ACCESS TO THOSE
DATASETS AND COLLABORATE IN SUB
ZAHARANT AFRICA SO THEY WOULD BE
ABLE TO APPLY.
>> MY COMMENTS IS, SOCIAL
DETERMINANTS OR HEALTH YOU CAN
BAN THE WORD BUT IF YOU HAVE TO
DO IT MICROBIOME AND
INFLAMMATION AND NEURAL INPUT
IT'S DIFFICULT TO DIS ENTANGLED
FROM DISPARITIES SO I GUESS YOU
HAVE TO BE CAREFUL IN THE WAY
YOU WRITE IT.
THEY ARE THE DISPARITIES.
>> YES, CERTAINLY, WE UNDERSTAND
THAT, THANK YOU.
>> IT'S A TOUGH BOUNDARY TO TRY
AND DRAW BUT CLEARLY OUR HOPE IS
THAT THERE'S FLEXIBILITY THAT
ALLOW PEOPLE LOOKING FOR FACTORS
TO BE ADDRESSED.
WITHOUT DOING SO, I THINK YOU
RUN THE RISK OF DOING SOMETHING
THAT DOESN'T QUITE ADDRESS THE
CONCERNS.
ONE OTHER PIECE I THINK WAS
MENTIONED TOO IS THAT THE
COMPARISONS AND IT CAME TO ME
BECAUSE I TALKED ABOUT COHORTS.
MY UNDERSTANDING AND CORRECT ME
IF I'M WRONG, IS THE INTENT IS
TO COMPARE PEOPLE WITH HIV TO
PEOPLE WHO DON'T HAVE HIV.
AND IN THAT WE TROY TO
DISENTANGLE OR UNDERSTAND BETTER
WHAT THIS DRIVING BOTH TO
DISPARITY WITHIN THAT POPULATION
AND HIV BUT ALSO HETEROGENEITY
OF PEOPLE WITH HIV.
>> YES, THAT'S CORRECT.
>> I DON'T SEE ANY OTHER HANDS.
SO, I THINK WE CAN MOVE TO
VOTING.
>> I MOVE TO A OF T PROVE.
>> SECOND.
>> AND ANY FURTHER DISCUSSION?
>> AGAIN, THE DISCUSSION IS NOT
HEADING IN THE DIRECTION OF A
DEFERRAL SO LOOKING SPECIFICALLY
FOR IAPPROVAL AND DISAPPROVAL
ASSUMING IF YOU ARE DIGITALLY
CONNECTED YOU ARE PROVING AND
THAT'S THE MOTION ON THE TABLE.
ANYONE DISAPPROVAL, RAISE YOUR
HANDS OR A VOICE OF A
DISAPPROVAL VOTE PLEASE.
I DO NOT SEE ANY.
ANY ABSTENTIONS?
NO.
OK, PAULETTE.
>> IT'S UNANIMOUS APPROVAL.
>> WE ARE GOOD.
>> ALL RIGHT.
MOVING ALONG THE NEXT IS A PAR
CONCEPT MECHANISTIC LINKS
BETWEEN DIET, LIPID METABOLISM
AND TUMOR GROWTH AND PROGRESSION
AND Dr. CHRISTINE WILLIS IS
PRESENTING.
MEMBERS ARE DOCTORS WHO IS
UNABLE TO JOINS TODAY BUT DID
PARTICIPATE IN PRIOR DISCUSSIONS
AND WRATHMALL.
>> THANK YOU, Dr. FLARE TEE.
I'M HAPPY TO PRESENT THIS ON
FUNDAMENTAL STUDIES OF
INFLUENCES ON LIPID MECHANISMS
OF TUMOR GROWTH AND PROGRESSION.
WHICH IS PART OF NCI SUPPORT FOR
ARE THE LARGER NIH 10-YEAR
STRATEGIC PLAN FOR NUTRITION
RESEARCH.
MY WAY OF BECOME GROUND I'D LIKE
TO TOUCH ON CANCER METABOLISM IN
GENERAL.
CANCER METABOLISM THREE
COMPONENTS.
THE BIOLOGY OF THE TUMOR, THE
TUMOR MICRO ENVIRONMENT AND
THESE THREE SYSTEMS ARE
INTERCONNECTED AND CAN'T REALLY
BE UNDERSTOOD WITHOUT REFERENCE
TO EACH OTHER.
BUT TODAY, I'M GOING TO FOCUS
SPECIFICALLY ON NUTRIENT
AVAILABILITY.
AND THE NUTRIENTS IN A TIMER
REQUIRES TO SUPPORT ITS
PROGRESSION CAN BE SOURCED FROM
A VARIETY OF PLACES AND THEY CAN
BE DRAWN DIRECTLY FROM THE
PLASMA OR FROM TUMOR FLUID AND
THEY CAN BE TAKEN FROM STROMAL
CELLS OR THEY CAN BE EXTRACTED
FROM THE EXTRA CELLULAR MATRIX,
AND THERE'S ANOTHER SOURCE THAT
WE TEND NOT TO THINK ABOUT AS
OFTEN AND THAT IS THE DIET.
RECENT WORK SUGGESTS THAT DIET
RESPONSE ITS LIPID METABOLISM
CONTROLS TUMOR GROWTH AND
PROGRESSION.
AND THIS EMERGING AREA PRESENTS
WITH US A UNIQUE OPPORTUNITY TO
SUPPORT THE ADVANCEMENT OF
FUNDAMENTAL CANCER BIOLOGY.
AND PARTICULARLY THERE'S BEEN A
NUMBER OF RECENT DISCOVERIES IN
THIS AREA THAT ARE TIMELY AND
SIGNIFICANT.
IT'S BEEN SHOWN THAT CALORIC
RESTRICTION IS TUMOR GROWTH BY
FATTY ACIDS AND IT SHOWED THAT
HIGH-FAT DIET COMPROMISES
ANTITUMOR BY INTERFERING WITH
THE TUMOR MIKE ROLL ENVIRONMENT
AND RESTRICTING DIETARY GLY
SCENERY DUCES TUMOR GROWTH BY
RECUSING TOXICS LIPID SPECIES
AND AS FINAL EXAMPLE DIETARY
ACID PROMOTES METASTASIS AND
THROUGH TUMOR ASSOCIATED SWAN
CELLS.
THIS IS ALSO AN IMPORTANT
OPPORTUNITY RIGHT NOW BECAUSE
THE FIELD OF FUNDAMENTAL CANCER
BIOLOGY IS JUST BEGINNING TO
HAVE MODELS THAT INCORPORATE THE
TUMOR MICRO ENVIRONMENT SO WE
HAVE THE ABILITY TO STUDY THIS
AND IN A MEANINGFUL WAY.
THERE'S BEEN A NUMBER OF RECENT
METH LOGICAL IN WAYS IN
COMPUTATIONAL MODELS WHICH ARE
IMPORTANT FOR UNDERSTANDING THIS
AREA AND THE KIND OF SYSTEMS BY
OLE GOUGH APPROACHES THAT ARE
ALSO IMPORTANT FOR UNDERSTANDING
THAT AREA.
IT'S A COMPLEX PROBLEM.
THE TUMOR MICRO ENVIRONMENT IS
COMPLEX WITH DIFFERENT KINDS OF
CELLS AND LIPID BIO CHEMISTRY
COMPLEX WHEN YOU CONSIDER THE
HEAD GROUPS THAT LIPIDS CAN HAVE
AND THE LENGTH OF THE CHAIN AND
THE POSITION OF THE NUMBER OF
DOUBLE BONDS, THERE ARE MORE
THAN 100,000 DIFFERENT SPECIES
OF LIPIDS PRESENT.
THERE ARE STILL CHALLENGES
AROUND THE ISSUE OF KWANTATION
OF DIETARY VARIABLES AND HOW WE
DEFINE A HIGH FAT DIET.
OR CALORIC RESTRICTION AND THERE
ARE INSUFFICIENT BRIDGES BETWEEN
RESEARCH ON NUTRITION AND
FUNDAMENTAL CANCER BIOLOGY AND
WE HOPE THIS PROPOSED CONCEPT
WILL HELP ADDRESS THESE
CHALLENGES.
THEY HAVE FOCUSED ON OTHER
DIFFERENT AREAS AND BEHAVIORAL
SIGNS AND MICROBIOME AND THEY
ARE FOCUSED ON EPIDEMIOLOGY AND
RISK AND PREVENTION AND
MICROBIOME.
IN RECENT YEARS BETWEEN FISCAL
2017 AND 2021, NCI MADE 15
AWARDS SO THAT'S 15 AWARDS IN
FIVE YEARS ON APPLICATION THAT'S
INCORPORATED DIET OF WHAT ARE
MORE ASPECTS OF IT'S A SMALL
PORTFOLIO AND THIS CONCEPT WOULD
CONSIST OF TWO PASRs USING THE
RO1 AND R21 MECHANISMS AND RO1
MADE UNDER THIS PROGRAM WOULD BE
RENEWED FOR THE PARENTS AND THE
AWARDS WE WOULD LIKE TO MAKE
WOULD BE AIMED AT ACHIEVING
THREE PURPOSES AND THROUGH WHICH
MODULATES TUMOR GROWTH AND
PROGRESSION THROUGH THE WITH THE
FIELDS, AND TO STIMULATE
RESEARCH AND TOOL DEVELOPMENT
AND IN THIS AREA AND THE CONCEPT
ALLIANCE WITH GOAL FOUR WHICH IS
TO IMPROVE THE USE OF FOOD AS
MEDICINE AND OTHER RECENT NIH
STRATEGIC PLAN FOR NUTRITION AND
RESEARCH AND MY COLLEAGUES, MY
MEDICAL COLLEAGUES HAVE MORE
ELEMENTARY DESCRIBED THE NEED
FOR ADDITIONAL TO HELP THEM MAKE
DIETARY RECOMMENDATIONS TO
PATIENTS.
THE PROPOSED CONCEPT FILLS A GAP
THAT IS IDENTIFIED HERE AT NCI
AND IT'S IDENTIFIED BY SUBJECT
MATTER EXPERTS DURING THE
JULY 2021 WORKSHOP ON DIET AS A
MODIFIER OF TUMOR METABOLISM.
THE IDEA IS TO STAB A COMMUNITY
OF PRACTICE THROUGH SEVERAL
DIFFERENT INITIATIVES AND
BRINGING TOGETHER BIOLOGISTS
THROUGH THE AWARD AND IT WILL
STRONGLY ENCOURAGE APPLICANTS TO
EITHER USE AN MPI OR CO PI
MECHANISM TO ENSURE THERE'S
ADEQUATE EXPERTISE FROM
NUTRITIONISTS ON THE GRAND AND
APPLICATIONS THAT DO NOT HAVE
NUTRITION EXPERTS WHO WOULD BE
CONSIDERED NONRESPONSE I HAVE.
I WANT TA HOSPITAL A MEETING FOR
REWARDERS AND ESTABLISH OUR
WORKING GROUP AND OUR HOPE IS
THAT BETTER UNDERSTANDING OF THE
DIE AARTI INFLUENCES LIKE CANCER
WILL ADVANCE THE LONG-TERM GOAL
OF IMPROVING THE RECOMMENDATIONS
FOR PATIENTS AND DEVELOPMENT OF
METABOLIC THERAPIES AND JUST A
FEW EXAMPLES AND I WANT TO POINT
OUT THIS IS NOT AN INCLUSIVE
LIST JUST EXAMPLES AND WHAT ARE
THE MOLECULAR MECHANISMS THAT
MODERATE THE EFFECTS OF
DIFFERENT SPECIES ON DIETARY
LIPIDS SUCH AS ACID ON TUMOR
PROFESSION AND HOW TO DIET
DRIVEN VARIATIONS IN THE LEVEL
OR COMPOSITION OF FATTY ACIDS IN
FLUID IMPACT TUMOR AND STROMAL
CELLS AND MIGHT OWE CON DEGREAL
FUNCTION AND THE REACTIVE OXYGEN
SPECIES AND HOW THE DRIVER
MUTATIONS SUCH AS P53, KRAS AND
MYC IN TUMOR CELLS IN RESPONSE
TO DIET.
HOW ARE ALTERATIONS IN DIET
RESPONSIVE LIPID METABOLISM IN
TUMOR BUFFERED OR ENHANCED BY
THE TUMOR MICRO ENVIRONMENT AND
WHAT ARE THE MOLECULAR
MECHANISMS THROUGH DIET
RESPONSIVE CIRCULATING FACTORS
IN SUCH AND STEROID HOR MONTHS
INFLUENCE CANCER CELL METABOLISM
IN TUMOR PROCESS AND THE TUMOR
MICK REENVIRONMENT IN THE
ABSENCE OF WEIGHT GAIN AND
APPLICATION THAT'S EXAMINE HOW
ANY OF THE ABOVE TOPICS OR ANY
OTHER TOPICS THAT THEY SUBMIT
THAT WOULD BE RESPONSIVE
CONTRIBUTE TO HEALTH DISPARITIES
ARE WELCOMED AND ENCOURAGED.
PORTFOLIO ANALYSIS IS VERY
IMPORTANT TO US SO EVALUATION OF
AWARDS MADE UNDER THIS PROGRAM
WILL BE BASED ON MEASURABLE
PERFORMANCE CRITERIA AND
INCLUDING BUT NOT LIMITED TO THE
CHANGE IN THE NUMBER OF
COLLABORATIONS AND BETWEEN
NUTRITION SCIENTISTS AND
DETERMINED BY NETWORK ANALYSIS
AND THE TIMELY DISSEMINATION OF
RESEARCH FUNDING THROUGH PRE
PRINTS AND JOURNAL ARTICLES AND
THE DEVELOPMENT OF RESOURCES AS
WELL AS A SHARING OF THOSE
RESOURCES WITH THE WIDER
SCIENTIFIC COMMUNITY AND THE
ACTIVE PARTICIPATION OF AWARDEES
IN THE WORK BE GROUP AND OTHER
RELATED ACTIVITIES AND ADHERENCE
TO NCI POLICIES AND BEST
PRACTICES INCLUDING DATA
SHARING.
SO, TO SUMMARIZE, THEY CAN
DIRECTLY INFLUENCE TUMOR GROWTH
AND PROGR BOTH
CELL AUTONOMOUS MECHANISMS AND
THE PROPOSED CONCEPT FILLS A GAP
IN THE NCI PORTFOLIO AND WILL
LEVERAGE RECENT DISCOVERIES AND
METH LOGICAL INNOVATIONS TO
ADVANCE GOAL 4 OF THE 10-YEAR
NIH STRATEGIC PLAN FOR
NUTRITIONAL RESEARCH AND
APPLICANTS WILL BE EXPECTED TO
INCLUDE NUTRITIONISTS THROUGH AN
MPI OR CO-PI STRUCTURE
ESTABLISHING BRIDGES THROUGH A
HISTORICALLY SILOED COMMUNITIES
OF NUTRITION SIGNS AND MOLECULAR
METABOLISM AND BETTER
UNDERSTANDING OF DIETARY
INFLUENCES ON FUNDAMENTAL CANCER
METABOLISM THAT WILL ENHANCE
NUTRITIONAL RECOMMENDATIONS FOR
PATIENTS AS WELL AS THE
POTENTIAL DEVELOPMENT OF
METABOLIC THERAPIES.
I WANT TO THANK THE MEMBERS OF
THE SUBCOMMITTEE FOR THE VERY
HELPFUL SUGGESTIONS AND FOR
MEETING WITH US TO DISCUSS THIS
CONCEPT.
AND WITH THAT I YIELD TO THE
BOARD.
>> GREAT.
THANK YOU, CHRISTINE.
WOULD YOU LIKE TO START THE
DISCUSSION?
>>
>> SURE, SO, I WANT TO JUST
THANK YOU Dr. WILLIS FOR HER
EXCELLENT PRESENTATIONS OF THIS
CONCEPT AND ALSO THANK THE
DOCTOR FOR BEING PART OF THE
SUBCOMMITTEE AND WE HAD AN
INITIAL MEETING OF THE
SUBCOMMITTEE AND MET WITH Dr.
WILLIS AND HER COLLEAGUES IN A
SECOND MEETING BUT THE REVIEWERS
ALL OF US FELT THIS WAS REALLY
AN IMPORTANT AND TIMELY TOPIC
AND THAT WILL DRAW A LOT OF
INTEREST FROM SCIENTISTS IN THE
FIELD AND IT'S ALSO INCREDIBLY
IMPORTANT TO PATIENTS WHO ARE
REALLY INTERESTED IN ANSWERS
HAVING THESE QUESTIONS AND SADLY
MANY OF THEM ARE NOT GETTING
THEIR DATA ON THIS FROM EVIDENCE
BASED SOURCES SO THIS WILL HELP
BUILD THAT EVIDENCE AND THE
PORTFOLIO REVIEW DOES INDICATE A
NEED FOR THE FUNDING
ANNOUNCEMENT SPECIFICALLY IN
THIS AREA AND YOU KNOW THIS AREA
IS A RESEARCH GAP WAS IDENTIFIED
AND THE JULY 2021 WORKSHOP AND
OTHER POSITIVES OF BEING PART OF
THE RPG POOL AND ABOUT THIS IDEA
OF HAVING AN ANNUAL MEETING FOR
GRANTEE TO MEET AND INCLUDING A
NUTRITIONIST ON THE TEAM TO SORT
OF BRIDGE THOSE LACK OF
COMMUNICATION BETWEEN THE TWO
FIELDS AND SOME CONCERNS THAT
WERE RAISED IN THE INITIAL
REVIEW WE WANTED TO SEE HOW IT
FITS IN WITH THE NUTRITION
STRATEGIC PLAN AND ELABORATION
ON THAT AND THE FOCUS OF THE
OTHER CONCERN WAS THE FOCUS OF
THE WHEN WE KNOW THERE ARE MANY
OTHER AREAS THAT ARE RELATED TO
NUTRITION THAT WOULD BE RELEVANT
TO AND THINKING ABOUT OBESITY
AND INFLAMMATION AND THEY
DESCRIBED THIS SORT OF TOUCHING
ON PART OF THE ELEPHANT AND AND
THE CANCER PREVENTION DIVISION
AND AND I'LL TURN IT OVER TO THE
DOCTOR TO SEE IF SHE WANTS TO
ADD ANYTHING.
>> OUR CONVERSATIONS ARE WELL
AND I THINK I'LL JUST PUT A FEW
MORE POINTS OF FATAH SIS.
BREAKING DOWN OF SILOS BETWEEN
NUTRITIONIST AND MOLECULAR
METABOLISM PEOPLE WE FELT WAS
THE BIGGEST BENEFIT OF THIS AND
IT'S A REAL PROBLEM AND WE
WANTED TO MAKE SURE WAS CAPTURED
IN THE NUTRITION PART WAS
OBESITY AND I'LL PUT ANOTHER
PLUG IN MORROW BEES TEE AND WE
CAST A WIDE NET BUT IN GENERAL,
WE SAW THIS AS IMPORTANT AND
UNDERFUNDED AND RECOGNIZED BY
THE NCI.
ANY QUESTIONS OR COMMENTS?
>> WHEN YOU TALK ABOUT CANCER
PATIENTS, AND SO DOES THIS
INCLUDE SURVIVE OR POPULATIONS
BECAUSE, DIET AND ISSUES
RELATING TO DIETARY IMPACT IN
THE SURVIVORS AND THIS IS A
MAJOR ISSUE SO YOU CAN CLARIFY
IF THIS IS RESPONSIVE IN IF
SOMEONE SUBMITS A APPLICATION IN
RESPONSE TO CANCER SURVIVORS?
>> SO I THINK IF THEY'RE LOOKING
AT TUMOR GROWTH OR EXIT FROM DOR
MAN SEE AND HOW THAT WOULD BE
CONSIDERED RESPONSIVE.
I WOULD CONSIDER THAT
RESPONSIVE, SURE.
AND I WOULD ALSO LIKE TO ADD, WE
WOULD CONSIDER APPLICATIONS THAT
DEALT WITH OBESITY AND
MICROBIOME AND LIPID METABOLISM
TO BE RESPONSIVE SO WE AGREE
THAT THOSE ARE IMPORTANT TOPICS
AS WELL.
>> THIS IS, I THINK THIS IS
TERRIFIC AREA AND THAT NEEDS
INVESTMENTS.
DRUGS MODIFY THROUGH THE
METABOLISM AS WELL SO DO YOU
INVASION THAT FUNCTION OF TREAT
STRATEGIES AND THE STUDY OF THAT
WOULD BE PART OF THE RESPONSIVE
APPLICATIONS?
>> YOU BROKE UP A LITTLE BIT.
I'M SORRY.
I THINK YOU ASKED THE QUESTION
WHICH WAS, WE ALL AGREE THAT
THERE ARE DRUGS THAT WOULD
EFFECT METABOLISM AS WELL AND
WITH THOSE BE INCLUDED AND YES,
I THINK THAT THOSE WOULD BE
CONSIDERED RESPONSIVE.
>> LET ME TRY AGAIN.
I'M GOING TO TURN MY VIDEO OFF
IT MIGHT HELP.
WOULD THE DIET BE A FUNCTION OF
THE DRUGS THAT PEOPLE ARE
TAKING?
>> THAT'S A VERY INTERESTING
QUESTION WOULD THE DIET BE A
FUNCTION OF THE DRUGS AND I
THINK THAT'S WORTH
INVESTIGATING, YEAH, SO I THINK
IT'S AN INTERESTING QUESTION,
YES.
>> ARE YOU, ARE YOU PLANNING TO
INVOLVE PATIENT ADVOCATES?
>> I THINK THAT THAT WOULD BE A
GREAT THING IF PATIENT ADVOCATES
WOULD LIKE TO BE INVOLVED IN
THIS AS WELL.
>> SOME REQUIRE PATIENT
ADVOCATES.
>> HERE BECAUSE WE'RE DEALING
WITH FUNDAMENTAL RESEARCH, AND
THAT IS WHETHER IS FOCUSED IS ON
THE FUNDAMENTAL BIOLOGY OF THIS
BECAUSE IT'S SO EARLY ON AND SO
I WOULD DEFER TO THE PIs
PROBABLY ON THAT AND I CAN
IMAGINE THAT FOR SOME PROJECTS
IT DEPENDS ON THE PROJECTS IT
SOMETHING WE WOULD BE OPEN TO.
>> THIS IS A GREAT INITIATIVE
AND I'M A LITTLE BIT FUSED BY
THE FACT THAT THIS DOES
EMPHASIZE FUNDAMENTAL SCIENCE
BUT YOU ARE REALLY PRIORITIZING
MPI APPLICATIONS FROM
NUTRITIONISTS WHICH, IS THAT
IMPLYING CLINICAL NUTRITIONISTS
OR JUST SCIENTISTS.
A LOT OF THOSE FOLKS ARE
OBVIOUSLY REALLY IMPORTANT I
THINK IN THE THOUGHT PROCESS BUT
MAYBE LESS INVOLVED NATURALXA
FUNDAMENTAL SCIEN AND THAT WAS R
OUTCOME OF OUR WORKSHOP IN 2021
IN THE SUMMER OF 2021 IS ALL OF
OUR PANELISTS SPOKE AT LENGTH
ABOUT THE NEED TO INVOLVE MORE
LINKS BETWEEN DIFFERENT PARTS OF
THE CARE FROM NUTRITIONISTS AND
FUNDAMENTAL BIOLOGIST AND SO THE
IDEA HERE IS THAT THIS IS A
FUNDAMENTAL BIOLOGY
INVESTIGATION BUT BECAUSE DIET
IMPACTS THE FUNDAMENTAL POLL HE
CAN YOU LAR METABOLISM AT THE
CELLULAR LEVEL THAT WE WANT TO
INCLUDE THE NUTRITIONISTS AND
JOIN THOSE TWO FIELDS TOGETHER
AND SORT OF BRIDGE THAT
HISTORICALLY EXISTING DIVISION
SO IT'S CERTAINLY A FUNDAMENTAL
BIOLOGY INITIATIVE AND WE THINK
IT'S IMPORTANT BECAUSE WE NEED
TO UNDERSTAND, AS ONE OF THE
BOARD MEMBERS JUST SAID, VERY
ELOQUENTLY, WE NEED TO
UNDERSTAND THE FUNDAMENTAL
MOLECULAR METABOLISM IN ORDER TO
MAKE GOOD RECOMMENDATION TO
PATIENTS.
THE IDEA IS TO HAVE A
FUNDAMENTAL MOLECULAR METABOLISM
INITIATIVE THAT INCORPORATES ADD
VOICE FROM NUTRITION SCIENTIST
AND NUTRITIONIST AND DIETITIANS.
>> SO NUTRITIONIST IS BEING
DEFIND BROADLY.
>> RIGHT.
>> SO NUTRITIONAL EPIDEMIOLOGIST
OR NUTRITIONAL SCIENTIST WOULD
BE --
>> IF THAT'S THE MOST
APPROPRIATE THING FOR THAT
PROJECT, YES.
>> THANK YOU.
>> I WAS ASKING TO REQUEST, I
THINK BEING A LITTLE BIT MORE
PRECISE ABOUT WHAT A
NUTRITIONIST IS GOING TO BE
IMPORTANT.
>> OK.
>> I THINK BEFORE --
>> HOWARD, GO AHEAD.
>> WE BRING UP THIS ISSUE OF
DRUGS AND WHAT SKILLS SETS MIGHT
BE APPLICABLE TO THIS KIND OF
RESEARCH, I JUST WANTED TO PUT
IN TWO CENTS FOR ONE IS THAT
IMMUNO ONOLOGISTS AND THE SECOND
IS THE NUCLEAR MEDICINE PEOPLE.
I THINK YOU KNOW THERE'S BELIEF
AMONG SOME THAT THE HEALTH OF
THE LIMP NODE SYSTEM AND THE
IMPACT OF FIRST LINE TREATMENTS
LIKE PLATINUM.
IT MITIGATE THE TOXICITY TO
NORMAL ISSUE AND THE PATENT THAT
WAS DEVELOPED AROUND THAT AND
IT'S BEEN HELD UP AND NUCLEAR
MEDICINE AND IN INDUSTRY AND
SOME ARE THESE TESTED AS MICRO
PET WHERE YOU CAN DO PET SCANS
ON ANIMAL MODELS AND THE BELIEVE
THAT THAT CAN REFER YOU TO
PEOPLE AND I DON'T KNOW THAT
MANY ACADEMIC GROUPS THAT ARE
USING THOSE TECHNOLOGIES BUT YOU
KNOW, IT'S SOMETHING THAT HAS
GUIDED TREATMENTS AND MAYBE
INTEREST IN CERTAIN TUMOR TYPES.
IF YOU SAW CON SIS TAN SEE AMONG
LIMB NOAM A AND SOLID TUMORS YOU
MAY MAKE DIRECTING TREATMENT
TOWARDS LYMPHOMA AND THEY FELT
THEY'RE MORE SUSCEPTIBLE TO
THESE KINDS OF MANIPULATIONS AS
A THERAPEUTIC APPROACH.
>> THANK YOU, THAT IS AN
EXCELLENT POINT.
>> I. HAPPY TO TAKE IT OFF LINE
BUT I WAS GOING TO ASK ABOUT
COMMUNITY OF PRACTICE BECAUSE
THAT WOULD JUST EXCITED TO SEE
THAT BUT NO NEED TO SPEND TIME
ON IT HERE.
>> THANK YOU.
I THINK WE'LL MOVE TO VOTING.
THE DISCUSSION IS NOT HEADING IN
A DIRECTION OF DEFERRAL SO WE
GET A MOTION FOR APPROVAL VERSUS
DISAPPROVAL.
>> I MOVE FOR APPROVAL OF THE
PAR.
>> GREAT, CAN I GET A SECOND.
>> I SECOND.
>> GREAT.
NEED FOR FURTHER DISCUSSION?
>> AND I THINK YOUR HAND IS
STILL UP FROM THE PRIOR
QUESTION.
HOWARD THE SAME.
OTHERWISE, NO EVIDENCE.
GREAT.
OK.
SO, ANY FURTHER DISCUSSION WE'LL
TAKE A FINAL VOTE AND SUBMISSION
FOR APPROVAL SO I WILL SEE
APPROVAL UNLESS YOU VOSS A
DISAPPROVAL VOTE OR RAISE YOUR
HAND.
>> ANY AB TENSION.
>> WE'RE GOOD.
>> THANK YOU.
>> NEXT IS AN RFA CONCEPT
ADVANCING ADOLESCENT TOBACCO
SEES ACE.
>> THANK YOU FOR THIS
OPPORTUNITY TO PRESENT OUR
CONCEPT ADVANCING ADOLESCENT
TOBACCO CESSATION INTERVENTION
RESEARCH.
I'LL BEGIN BY PROVIDING A BRIEF
BACKGROUND.
MOST TOBACCO USE BEGINS IN
ADOLESCENTS, WITH USES
ESCALATING IN THE MID TO LATE
ADOLESCENT PERIOD AROUND HIGH
SCHOOL AND THE FEW YEARS BEYOND
AND HELPING YOU TO QUIT TOBACCO
USE EARLY IS CRITICAL TO CANCER
PREVENTION AND CONTROL AS COULD
ANNA VOID A SUBSTANTIAL AMOUNT
OF THE TOBACCO CAUSE MORBIDITY
AND MORTALITY BUT IT'S
INCREASINGLY COMPLICATED IN
RECENT YEARS AND WE'RE NOT JUST
PRIMARILY FOCUS ON CIGARETTES
ANYMORE, THERE'S TOBACCO PRODUCT
USE ON THE MARKET AND IN USE BY
ADOLESCENTS INCLUDING THE
NICOTINE Ns AND YOU MAY KNOW
AS E CIGARETTES AS WELL AS CIGAR
PRODUCTS LIKE LITTLE CIGARS AND
THESE OFTEN COME IN FLAVORS AND
MARKETING THAT APPEALS TO YOUTH
AND THIS PRODUCT DIVERSITY HAS
MORE COMPLEX USE PATTERNS AND
SUCH AS DUEL OR THE USE OF TWO
OR MORE PRODUCTS IN THE SAME
TIME PERIOD AND IN RECENT YEARS,
AS THE AVAILABILITY OF CANNABIS
HAS INCREASED, CO USE OF
CANNABIS AND TOBACCO IS MORE
PREVALENT.
>> ADOLESCENCE IS UNIQUE TIME
PERIOD AND IT'S THE PERIOD AT
WHICH INDIVIDUALS ARE MOST AT
RISK OF INITIATION AND
ESCALATION OF TOBACCO USE AND
ADOLESCENT TOBACCO USE DEVELOPS
ALONG VARIOUS TRAJECTORIES WITH
SUBSTANTIAL HETEROGENEITY IN
THESE PATTERNS AND SOME QUICKLY
ESCALATE TO DAY LIE USE AND
OTHERS PERSIST AT LOW LEVELS
OVER TIME.
INTERVENING DURING THE
ADOLESCENT YEARS PROVIDES UNIQUE
LAYERS OF OPPORTUNITY TO DISRUPT
THIS USE EARLY OR TREAT
ESTABLISHED DEPENDENTS EARLY
BEFORE IT SOLIDIFIES LONG-TERM
USE AND IT'S HEALTH CONSEQUENCE.
HAVE ADOLESCENTS IS A UNIQUE
PERIOD OF NEURO COGNITIVE AND
PSYCHOSOCIAL DEVELOPMENT WITH A
INTENSE FOCUS ON ESTABLISHING
PEER RELATIONSHIPS AND ONES'
IDENTITY AND IT'S THE TYPE WHERE
THE PREFRONTAL CORTEX IS STILL
ACTIVELY DEVELOPING WHICH IS THE
AREA OF THE BRAIN GOVERNING
LEARNING MEMORY AND IMPULSE
CONTROL AND SO THEY ARE NOT
FULLY FORMED AND SO IT'S
IMPORTANT TREATMENT IMPLICATIONS
AND IMPORTANT IMPLICATIONS FOR
THE APPROACHES THAT WE TAKE WITH
YOUTH FOR SEESATION.
AND WE HAVE THE REPORT TRYING TO
QUIT AND HOWEVER, WE CURRENTLY
HAVE FEW VALIDATED TOBACCO
ASSOCIATION INTERVENTION TO
OFFER THEM AND AND REVIEWED IN 7
BY THE COCHRAN GROUP AND 2020 BY
THE TASK FORCE REVIEWING PRIMARY
CARE FEASIBLE CESSATION
INTERVENTIONS AND THEY
RECOVID-19 BEHAVIORAL
INTERCEPTIONS TESTED IN
ADOLESCENCE THAT STUDIED THE
EFFECTS OF MEDICATIONS THAT ARE
FDA APPROVED FOR ADULT TOBACCO
CESSATION AND THE MAJOR
TAKEAWAYS FROM THESE REVIEWS
THERE WAS LITTLE SUPPORT FOR THE
CURRENT TESTED BEHAVIORAL
INTERVENTIONS WITH THE EXCEPTION
OF THE COCHRAN FINDING AND
EFFECT FOR GROUP COUNSELING
INTERVENTIONS LEGALITIES AND
THERE WAS NO SUPPORT FROM
MEDICATIONS USING IN ADOLESCENT
POPULATIONS TO DATE AND THE
STUDIES FOCUSED ON CIGARETTE
SMOKING CESSATION SO THERE'S
EVIDENCE FOR NON CIGARETTE
TOBACCO PRODUCTS AND STUDIES AND
POPULATIONS THAT EXPERIENCE
GREATER PREVENT AND BOTH
ACKNOWLEDGE THEY MAY PROMISE
TREATMENT DELIVERY AS WE ALL
KNOW ADOLESCENTS ARE MADE AND
USERS OF APPS AND TEXT MESSAGES
BUT INTERESTS A GAP IN TREATMENT
DELIVERING THESE PLATFORMS.
AND NEXT SLIDE, PLEASE.
AND OVER THE PAST FEW YEARS,
THERE'S BEEN A REMARKABLE
ALIGNMENT AMONG NCI AND AMONG
OUR FEDERAL PARTNERS AS WELL AS
THE SCIENTIFIC COMMUNITY AND THE
CLINICAL PARTNERS ON RESEARCH
NEEDS AND THE URGENCY OF
TREATING ADOLESCENT TOBACCO USE.
WHEN WE CONDUCTED -- NEXT SLIDE,
PLEASE.
WHEN WE CONDUCTED AN NIH WIDE
PORTFOLIO SEARCH WE FOUND VERY
FEW CURRENTLY ACTIVE GRANTS
CONDUCTING THIS TYPE OF RESEARCH
AND NON AT NCI.
TO MEET THIS CRITICAL NEED WE'VE
PROPOSED THIS RFA WITH THE GOAL
TO STIMULATE RESEARCH ON THE
DEVELOPMENT AND EVALUATION OF
TOBACCO CESSATION INTERVENTIONS
FOR ADOLESCENTS WITH THIS
ADOLESCENT PERIOD AND WE ARE
INTERESTED IN WELL DESIGNED
INTERVENTIONS THAT FOCUS ON THE
UNIQUE NEEDS OF ADOLESCENT
TOBACCO USE TEARS WILL TREAT
THIS TOBACCO DEPENDENCE EARLY OR
DISRUPT TOBACCO USE AND
APPLICATION TO ADDRESS THE RANGE
OF TOBACCO PRODUCTS AND THESE
MORE COMPLEX AS WELL AS VERY
IMPORTANTLY RESEARCH THAT BUILT
IN DESIGNS FOR AND PLANS FOR
DISSEMINATION AND IMPLEMENTATION
FROM THE BEGINNING STAGES OF THE
GRANT AND NEXT SLIDE, PLEASE.
SO SOME OF OUR EXAMPLE RESEARCH
QUESTIONS AND IN THE INTEREST OF
TIME I WON'T READ THEM ALL BUT
THEY RANGE FROM INCLUDING A
FOCUS ON THESE EFFECTIVE DIGITAL
THERAPEUTIC INTERVENTIONS AND
UNDERSTANDING HOW TO EFFECTIVELY
INTERVIEW WITH YOUTH ACROSS
THESE DIFFUSE PATTERNS AND
TRAJECTORIES OVER TIME AND AS
WELL AS HOW TO BETTER ENGAGE AND
EFFECTIVELY ENGAGE YOUTH IN
SUBGROUPS EXPERIENCED TOBACCO
RELATED HEALTH DISPARITIES AND
NEXT SLIDE, PLEASE.
SO WE PROPOSED FUNDING 10 AWARDS
USING BOTH THE RO1 AND R34
PLANNING MECHANISMS.
WE ARE ASKING FOR TWO RECEIPT
DATES WITH THE PLAN FOR TWO
AWARDS AND AND WE WILL ALLOW
LARGER BUDGETS FOR THE 104 SO WE
FOCUS ON ADOLESCENTS IN THIS
PERIOD TO ADDRESS WHAT WE SEE AS
THE AREA OF GREATEST NEED WITH
THE RESPECT TO THE EXISTING
EVIDENCE ON TOBACCO USE PATTERNS
AND ESCALATION AND THE GREATEST
EVIDENCE IN GAPS IN TREATMENTS
AVAILABLE FOR THIS AGE GROUP AND
WE SOLICIT RO1s TO TEST
INTERVENTION S WITH STRONG
PRELIMINARY DATA BUT WE ALSO
WOULD LIKE TO USE THE RO234
MECHANISM TO ALLOW FOR SOME
OTHER CLINICAL TRIAL PLANNING
GRANT ACTIVITIES AND THIS IS AND
ALLOW FOR ADEQUATE RESEARCH TEAM
S
FEASIBILITY AND STUDIES TO
IDENTIFY THE EFFECTIVE
RECRUITMENT RETENTION AND
ENGAGEMENT STRATEGIES FOR WHICH
THIS IS MORE CHALLENGING IN
PREVIOUS ADOLESCENT RESEARCH AND
THE RFA WILL ALLOW A SPECIALIZED
REGREW UP WHO ARE KNOWLEDGEABLE
ABOUT THIS DEVELOPMENT PERIOD AS
WELL AS TOBACCO CESSATION AND
FACILITATES THE CONVENE OF
GRANTEES TO DEVELOP SHARED
MEASURES AND METHODS ESPECIALLY
OUTCOME MEASURES WHICH WILL
ENHANCE ABILITY ACROSS STUDIES
AS WELL AS THE ABILITY FOR
THE GRANDE TO SHARE CHALLENGE
THIS IS REAL-TIME AND THE USE OF
TOBACCO PRODUCTS.
WE'RE GRATEFUL FOR THE
OPPORTUNITY TO HAVE MET WITH OUR
BSA SUBCOMMITTEE REVIEWERS.
AND OBTAIN THEIR INSIGHTFUL
FEEDBACK AND WE INCORPORATED
SOME OF THIS INTO THE TALK AND
FOR TIMES SAKE I'LL EYE LIGHT A
FEW ADDITIONAL POINT AND ALSO,
ACKNOWLEDGING THAT FROM THE
TREATMENTS TO DATE HAVE NOT BEEN
EFFECTIVE IN ADOLESCENT
POPULATION AND THEY'RE NOT THE
FOCUS OF THIS RFA AND WE SHOULD
ALLOW APPLICATIONS WHERE
TREATMENTS ARE ADJUNCT TO THE
BEHAVIOR TREATMENT PROTEASOMES
FROM IS THANK YOU FOR YOUR TIME
AND LOOK FORWARD TO THAT
DISCUSSION AND ANSWERING YOUR
QUESTIONS.
>> THANK YOU, VERY MUCH.
LET'S START WITH THE DISCUSSION.
>>
>> THANK YOU FOR SUCH AN
OUTSTANDING PRESENTATION AND
VERY INFORMATIVE AND ALSO THANK
YOU TO Dr. BASIN FOR THEIR
COMMENTS ON THIS RFA.
SO, I THINK IT WAS CLEARLY
INDICATED THE NEED FOR THIS RFA
AND WE CERTAINLY HAVE A DERTH OF
INFORMATION ON EFFECTIVE SMOKING
OR T TOBACCO SEESATION FOR TOOLS
AND HELPING ORGANIZATIONS AND
SCIENTISTS WITHIN THE TOBACCO
CONTROL FIELD THERE'S A DERTH IN
OF RESEARCH IN THIS AREA FUNDED
BY THE NCI.
THE SUBCOMMITTEE WAS SUPPORTIVE
OF THE PRIORITY AREAS THAT WERE
IDENTIFIED TO IN THIS RFA AND
THAT INCLUDED FOCUSING ON
DEVELOPING INTERVENTIONS THAT
TARGET DIFFERENT PHASES OF THE
TRAJECTORIES FOR TOBACCO USE AND
A LOT OF THE OPPORTUNITY EFFORTS
IN TERMS OF INTERVENTIONS HAVE
BEEN FOCUSED MOSTLY ON
ADOLESCENTS WHO ARE ADDICTED TO
TOBACCO AND TO FOCUS ON THE
ESCALATION PREVENTING THE
ESCALATION IN TOBACCO USE IS A
REAL NOVEL AND POTENTIALLY
EFFECTIVE TARGET.
AND IN ADDITION, AS YOU SAW,
THERE IS A REAL CHANGING OF THE
LANDSCAPE OF TOBACCO PRODUCTS
CURRENTLY OUT IN THE MARKET AND
WE HAVE NOT ONLY THE ELECTRONIC
SYSTEMS AND WE NOW ARE GOING TO
HAVE POACHES THAT COME IN
DIFFERENT FLAVORS AND A LOT OF
LITTLE CIGARS APPEALS TO YOUTH
SO IT'S A VERY COMPLEX
ENVIRONMENT AND THE ADOLESCENTS
ARE ACTUALLY RESPONDING TO THE
MARKETPLACE BY TAKING UP SOME
THESE NEWER PRODUCTS AND WE NEED
TO GET AHEAD OF THE GAME AND
COME OUT WITH INTERVENTIONS IN
TERMS OF REDUCING THE USE OF
THESE VARIOUS PRODUCTS AND WE
ALSO THOUGHT THAT THE PRIORITY
OF UTILIZING TECHNOLOGY IS VERY
IMPORTANT AND ESPECIALLY IN
ENHANCING INTERVENTIONS AND THAT
ARE MORE ADOLESCENT OR YOUTH
FRIENDLY AND WHAT IS REALLY GOOD
AND CERTAINLY USING TECHNOLOGY
WILL EXPAND REACH.
WE DID THINK THAT THE RFA NOW
RESPONDS TO SOME OF THE ISSUES
THAT WERE RAISED BY THE GROUP,
PARTICULARLY AS IT RELATES TO
MAKING SURE THAT THERE IS A
FOCUS ON SERVING DIVERSE
POPULATIONS, AND ALSO MAKING
SURE THAT THIS RFA INCORPORATES
IMPLEMENTAI AM NOT SCIENCE WITHE
RESEARCH PROPOSALS AND BRINGING,
I GUESS LET'S SEE, JUST TAKING A
LOOK HERE, AND ACTUALLY BRINGING
GREATER FOCUS TO SOME OF THE
COGNITIVE BEHAVIORAL TOOLS WOULD
BE COMPLIMENTARY TO THESE TOOLS.
AND I THINK THAT'S REALLY SOME
OF THE PRIMARY ISSUES THAT WE
WERE CONCERNED WITH.
DO YOU HAVE ANY OTHER COMMENTS
THAT YOU WOULD LIKE TO ADD?
>> NOT MUCH ON MY PART.
I HAD QUESTIONS ABOUT HOW THE
METH LOGIC RESEARCH WAS GOING TO
BE INCORPORATED.
THIS IS A NEEDED FUNDING
ANNOUNCEMENT AND WILL GENERATE
USEFUL AND IMPACTFUL RESEARCH.
>> THE ONLY THING THAT I WILL
ADD, THIS IS THOUGHTFUL IN TERMS
OF THE STRUCTURE OF THE RFA TO
BRING IN THE PLANNING BRANT
BECAUPLAN GRANTS BECAUSETHERE'SG
PLANNING FOR FEASIBILITY FOR
AWFUL THESE ISSUES AND BEFORE
ACTUALLY IMPLEMENTING AN OPEN
TRIAL WITHIN THESE SO I LIKE THE
MECHANISM VERY MUCH IN TERMS OF
THE COMBINATION OF RO1 COMES
R34s IN TERMS OF PLANNING
GRANTS SO HER GROUP HAVE BEEN
VERY RESPONSIVE TO OUR QUESTIONS
AND COMMENTS.
>> THANK YOU, WE HAVE SIX HANDS
RAISED.
FANTASTIC ENTHUSISM BUT LET'S
KEEP THE QUESTIONS TERSE AND
ANSWERS THE SAME.
MIKE YOU ARE FIRST I THINK.
>> YES SO, QUICK QUESTION, YOU
SAID NIAID WILL COME ON BOARD,
WHAT DOES THAT MEAN.
>> THANK YOU FOR THE QUESTION.
WE ARE IN DISCUSSIONS WITH OUR
NIAID COLLEAGUES AND KEVIN
WALTON PUT IN CHIEF AT NIAID ON
THE LINE TODAY AND HERE WITH YOU
THANK YOU VERY MUCH FOR BEING
HERE.
AND THEY INTEND TO JOIN OUR RFA
AND CONTRIBUTE BUT KEVIN IF YOU
WOULD LIKE TO ANSWER MORE IN
DEPTH, FEEL FRO TO UNMUTE AND .
>> THANK YOU, VERY MUCH, SO,
NIADA AND YOUTH CESSATION IS SO
ENTRANCE GENERAL WE'RE SO
FOCUSED ON THE INCREASED USE OF
Ns SO WE INTEND TO SIGN ON AND
FUND WORTHY APPLICATIONS AND WE
USE THE R34 MECHANISM ROUTINELY
AND OUR DIVISION SO WE'RE VERY
COMFORTABLE WITH THAT AS WELL
WITH THE R01, OF COURSE.
>> THANK YOU.
THANK YOU FOR THAT WONDERFUL
TALK AND THIS IS VERY WORTH
WHILE PROJECT.
I JUST HAD A QUESTION ABOUT THE
WORDINGS AT BEGINNING THE ETHNIC
AND RACIAL DIFFERENCES IN
TOBACCO USE DEPENDING ON THE
PRODUCT.
BUT THEN IN THE LAST SLIDE, THE
WORDINGS WAS SUCH THAT IT WAS
HIGH-RISK POPULATIONS AND I JUST
WANT TO MAKE SURE THAT IT'S --
IN MY OPINION IT NEEDS TO BE
SPECIFICALLY CALLED OUT AS
RACIAL AND ETHNIC DIFFERENCES
THAT SHOULD BE HIGHLIGHTED IN
THE RESEARCH AND I DON'T KNOW IF
YOU WANT TO REQUIRE OR STRONGLY
RECOMMEND IT BUT I THINK YOU
LIMIT THE DATA YOU GET OUT IF YU
DON'T CALL OUT RACIAL DIVERSITY
IN THE RFA.
>> THANK YOU SO MUCH FOR THAT
COMMENT.
YES, WE DO PLAN TO CALL THAT OUT
AND AS WELL AS THE NEED TO
CONSIDER RESEARCH QUESTIONS AND
THE PROVE ABILITY OF THE
INTERVENTIONS FOR NOT JUST
RACIAL AND ETHNIC GROUPS THAT
HAVE DISPROPORTIONATE USE OF
PARTICULAR PRODUCTS OR IN
GENERAL WERE EFFECTED BY TOBACCO
USE AND POPULATION PANELISTS AND
MENTAL HEALTH CONDITIONS ALSO
HAVE A HIGHER USE AND LGBTQ
YOUTH ARE ALSO USING TOBACCO
PRODUCTS AND WE'LL BE MORE
SPECIFIC ABOUT THIS WHEN WE HAVE
THEM IN THE RFA, ABSOLUTELY,
THANK YOU.
>> GREAT.
>> I JUST WANTED TO BEING OWE ED
I'M SUPPORTIVE OF THIS CONCEPT.
A COUPLE OF QUESTIONS, ONE IS,
YOU KNOW, I WONDERED IF THERE
WAS CONSIDERATION GIVEN TO BIO
MARKERS TO VALIDATE
SELF-REPORTED INFORMATION AND I
KNOW THE HISTORICALLY THESE
STUDIES HAVE INCLUDED
BIOMARKERS.
I KNOW THAT BECAUSE OF PRODUCTS
HAVE CHANGED I DON'T KNOW IF THE
BIOMARKERS ARE STILL AS VALID AS
THEY WERE DECADES AGO.
THE OFTEN TIMES INTERVENTIONS
HAVE A SHORT TERM EFFECT AND I
WONDERED IF YOU ARE ENCOURAGING
OUTCOMES REALLY TO THE
MAINTENANCE OR THE LONG-TERM
EFFECT OF THE INTERVENTION?
>> THANK YOU FOR THOSE
QUESTIONS.
I DO THINK WE WILL ENCOURAGE THE
BIOCHEMICAL CLIPS FOR INSTANCE
AND YOU ARE RIGHT IT'S A LITTLE
MORE COMPLICATED WITH THE
DIVERSITY OF TOBACCO PRODUCTS
BUT THE BY-PRODUCT OF NICOTINE
IS MEASURED IN THOSE PRODUCTS
AND FROM USE OF THESE PRODUCTS
AND IT WOULD BE USEFUL BUT YES,
WE WILL ENCOURAGE THAT IN THE
FRA OR FEASIBLE AS WELL AS
CONSIDER INCLUDING LANGUAGE TO
PLAN FOR THE UNDERSTANDING OF
THE CONTINUED USE OF TREATMENTS
OR THE MAINTENANCE OF THE
EFFECTS OF LONG-TERM FOLLOW-UP
AND ET CETERA.
WE SO DEFINITELY WILL
INCORPORATE THAT.
THANK YOU FOR HIGHLIGHTING THAT.
>> ALSO, GREAT PRESENTATION.
AND I'M REALLY GLAD THAT THIS
AREA IS BEING PERSUADE.
DIN YGIVENYOUR PRESENTATION IF A
WAY YOU COULD ENCOURAGE PEOPLE
TO THINK ABOUT PARTNERSHIP OR
COMMUNITY ORGANIZATIONS OR
GROUPS THAT HAVE REACHED INTO
THE GROUPS THAT YOU WOULD ALSO
LIKE TO REACH?
I'M THINKING OF YMCA AFTER
SCHOOL PROGRAMS OR SCHOOLS OR
OTHER PLACES BUT TO START TO
ENCOURAGE INVESTIGATORS TO THINK
ABOUT THAT A LITTLE BIT MORE
UPSTREAM AND SIMILARLY THINKING
ABOUT SORT OF THE END USER, THE
TEAM PERSPECTIVE AND HOW YOU
MIGHT INCORPORATE SIMILAR TO HOW
WE TALK ABOUT PATIENT ADVOCATES
THAT ADVISE AND GUIDANCE FROM
THE BEGINNING AS PART OF WHAT
YOU PUT OUT IN THE RFA.
>> AND AN ENTHUSIASTIC YES ON
ALL OF THOSE POINTS.
THIS WAS ACTUALLY PART OF OUR
DISCUSSION WITH OUR SUBCOMMITTEE
MEMBERS WHICH I REALLY
APPRECIATED AND WE ALL WERE
DISCUSSING THE NEED TO INCLUDE
IMPLEMENTATION SCIENTISTS ON THE
TEAMS OF COURSE FROM THE
BEGINNING OF THE DESIGN OF THE
INTERVENTION TO THE HE CAN
TIVENESS STAGE BUT IT'S CRITICAL
TO ENCOURAGE IN THE RFA
INVOLVEMENT IN YOUTH AND IN
DESIGN AND DEVELOPMENT AS WELL
AS THOSE COMMUNITY-BASED CONTEXT
IN WHICH THEY LIVE COMMUNITY
BASED PARTNERS AND TO ENHANCE
THE UPTICK AND ACTUAL REACH AND
USE OF THE INTERVENTIONED IF
THEY'RE FOUND EFFECTIVE.
WE ALSO THINK WE CAN ENCOURAGE
CBPR METHODS SO WE HAVE RESEARCH
METHODS THAT WOULD BE AS WELL AS
INCLUDING IMPLEMENTATION SCIENCE
AND METRICS SO THAT THEY CAN
BEING MEASURED AGO ALONG THE
WAY.
SO THOSE ARE SOME THINGS THAT WE
PLAN TO INCREASE.
THANK YOU.
>> GREAT.
IF YOU CAN PICK UP THE COMMENTS
IN THE CHAT REGARDING
MEDICATIONS USED TO TRYING TO
SUPPORT ASSOCIATION AND ALSO THE
FOCUS.
WE CAN MOVE TO VOTING.
NO COMMENTS THAT SUPPORTED
DEFERRAL SO I'M LOOKING FOR A
MOTION.
>> I MOVE TO APPROVE.
>> GREAT.
>> SECOND.
>> GREAT.
THANK YOU.
ANY FURTHER DISCUSSION?
SEEING NO HANDS.
WE'LL GO TO FINAL VOTING.
THE MOTION IS FOR APPROVAL.
WE WILL ASSUME APPROVAL VOTES
UNLESS YOU VOTE DISAPPROVAL,
RAISE YOUR HAND.
ANY A ABSTENTIONS?
>> IT'S UNANIMOUS.
>> GREAT.
NEXT CONCEPT IS IN RFA.
CANNABIS AND CAN ABBA NODE USE
IN ADULT CANCER PATIENTS DURING
TREATMENT ACCESSING BENEFITS AND
HARMS AND Dr. FREEDMAN IS THE
CHAIR Dr. CORONADO FOR
CHAIRING TWO SUBCOMMITTEES FOR
THIS MEETING.
GO AHEAD WITH YOUR PRESENTATION.
>> THANK YOU, VERY MUCH.
I'M PLEASED TO BE PRESENTING
THIS RFA CONCEPT TO YOU ON BOW
HALF OF MY COLLEAGUES FROM OUR
CANNABIS AND CANCER RESEARCH
GROUP.
THIS CONCEPT WAS DEVELOPED AS A
COLLABORATIVE EFFORT WITH
SUBSTANTIALLY INVOLVEMENT FROM
OUR INTEREST GROUP MEMBERS AND
IS A RESULT OF THE INPUT
SURVIVOR ADVOCATES AND KEY
STAKEHOLDERS.
NEXT SLIDE.
THE RAPIDLY INCREASING
AVAILABILITY IN USE OF CANNABIS
BY CANCER PATIENTS, OF LACK OF
EVIDENCE BASED AVAILABLE IN THE
HARMS OF BENEFITS DURING CANCER
TREATMENT, AND THE CHALLENGE TO
CLINICAL TRIALS DUE TO FEDERAL
REGULATORY ISSUES, CALLS FOR A
RAPID INFUSION OF MULTIPLE
STUDIES ADDRESSING CANNABIS USE.
THE PURPOSE OF THIS RFA CONCEPT
IS TO SUPPORT OBSERVATIONAL
RESEARCH STUDIES TO ASSESS THE
BENEFITS OF HOMES OF CANNABIS
AND CAN CANNABINOID USE.
IT CAN HAVE IMPORTANT EVIDENCE
OF THE BENEFITS AND HARMS OF
CANNABIS AND CAN AB INOID AND TO
CONDUCT FUTURE CLINICAL TRIALS.
NEXT SLIDE.
SO WE WERE TALKING ABOUT
CANNABIS OR CANNABINOIDS AND WE
REFER TO THE PLANT WE REFER TO
ANY CANNABIS PLANTS,
CANNABINOIDS, THC AND AS WELL AS
PRESCRIPTION CANNABINOIDS OR ANY
OTHER TRUCKS MADE WITH OR
DERIVED FROM CANNABIS.
AND FOR THIS PRESENTATION, I'M
GOING TO USE THE TERM CANNABIS
TO REFER TO CAN A BUSINESS AND
CANNABINOIDS.
SO, TO HELP US LEARN MORE ABOUT
THE STATE OF CANNABIS AND CANCER
RESEARCH, OUR INTEREST GROUP PUT
TOGETHER A CONFERENCE ON THE
TOPIC AND EXACTLY WHAT IT
RELATED DECEMBER 2021, WE WERE
ABLE TO PUT OUT A JNCI MONOGRAPH
DEVOTED TO THIS SYMPOSIUM.
I'LL START BY PROVIDING
BACKGROUND OF WHAT WE LEARNED.
THE LEGAL LANDSCAPE OF MEDICAL
AND NON MEDICAL CANNABIS USE HAS
CHANGED OVER THE AND STATE
POLICIES AND THERE ARE 37 STATES
IN THE DISTRICT OF COLOMBIA THAT
HAVE LEGALIZED CANNABIS FROM
MEDICAL CONDITIONS AND OF THESE,
19 STATES IN DC HAVE LEGALIZED
ADULT USE OF CANNABIS.
NEXT SLIDE.
AT THE SAME TIME, THE AVAILABLE
DELIVERY METHODS OF THESE
CANNABIS PRODUCTS HAVE ALSO
UNDERGONE SUBSTANTIAL CHANGES
AND THAT INCLUDE OIL, INHALED IN
TOPICAL FORMS.
NEXT SLIDE, PLEASE.
AND CANCER PATIENTS USE CANNABIS
DURING TREATMENT TO MANAGE
SYMPTOMS SUCH AS ANXIETY, LOSS
OF APPETITE, NAUSEA, PAIN AND
SLEEP DISTURBANCE AND THERE'S
SOME EVIDENCE FURTHER BENEFICIAL
EFFECTS AND THIS 2017 STUDY
SHOWED THAT LARGE PERCENTAGES OF
CANCER PATIENTS REPORTED USING
CANNABIS FOR PHYSICAL AND NEURO
PSYCHIATRIC SYMPTOMS AND
RECREATIONAL PURPOSES, AND O TO
TREAT THEIR CANCER AND THIS
STUDY FOUND THAT ONE IN FOUR
CANCER PATIENTS ARE USING
CANNABIS DURING THEIR TREATMENT.
WE THINK THIS MIGHT BE A LITTLE
HIGHER NOW.
OBSERVATIONAL STUDIES ALTHOUGH
SMALL, CONSISTENTLY SHOWED AN
ASSOCIATION BETWEEN CANNABIS USE
AND POOR OUTCOMES WITH PATIENTS
IN ADVANCE CANCER TREATED WITH
I'M UNION OWE THERAPY.
GIVEN THE INCREASE USE OF
IMMUNOTHERAPY AND CANNABIS IN
CANCER PATIENTS, HAVE A BETTER
UNDERSTANDING OF THE POSSIBLE
INCOMPETENTER ACTIONS BETWEEN
THE TWO THERAPIES IS NEEDED.
MOST U.S. MEDICAL ONCOLOGIST
ENGAGE IN DISCUSSIONS ABOUT
CANNABIS USE WITH PATIENTS, FEW
FEEL SUFFICIENTLY INFORMED TO
MAKE RECOMMENDATIONS.
PATIENTS OFTEN ARRANGE A
QUESTIONS ABOUT CANNABIS.
DO STUDIES SHOW THAT CANNABIS
CAN IMPROVE MY SYSTEMS AND HELP
TO TREAT MY CANCER.
WHAT ARE THE RISKS OF USING
CANNABIS IN IS IT SAFE WITH
OPIOIDS, WHAT ARE THE LAWS AND
REGULATIONS OF MY STATE AND WHAT
TYPES OF PRODUCTS ARE AVAILABLE
TO ME?
EVIDENCE GAPS WERE IDENTIFIED
FROM OUR SYMPOSIUM AND KEY AMONG
THEM ENCLOUD A NEED TO
UNDERSTAND HOW AND WHY CANCER
PATIENTS ARE CURRENTLY USING
CANNABIS AND WHETHER THE
BENEFITS AND HARMS OF CANNABIS
USE AMONG CANCER PATIENTS AND
ASSOCIATED WITH CANCER AND ITS
TREATMENT AND CO-MORBIDITY AND
OTHER MEDICATIONS THEY MAY BE
USING.
SO, ONCE AGAIN THE PURPOSE OF
THIS RFA IS TO SUPPORT OBJECT
VISIONAL RESEARCH STUDIES TO
ASSESS THE BENEFITS AND HOMES OF
CANNABIS USE AMONG CANCER
PATIENTS IN ADAPTIVE TREATMENT.
WE ARE REALLY LOOKING FOR
WELL-DESIGNED PERSPECTIVE COHORT
STUDIES OF CANCER PATIENTS WITH
TUMORS CURRENTLY RECEIVING
TREATMENT AND COMPARING THOSE
USING CANNABIS TO THOSE NOT
USING CANNABIS.
NEXT SLIDE.
THE NUMBER OF KEY RESEARCH
QUESTIONS THAT NEED TO BE
ADDRESSED.
THESE INCLUDE WHAT ADVERSE
EFFECTS OF CANNABIS USE ARE
OBSERVED IN KANG CANCER PATIEND
DOSE OF FREQUENCY AND DIFFERENT
SO HE ISES WITH IMPROVING CANCER
PATIENT SYMPTOMS AND HOW IS
CANNABIS USE ASSOCIATED WITH
CANCER PATIENT USE OF
MEDICATIONS AND TO MIMIC
SYMPTOMS FOR CANCER OR CANCER
RELATED TREATMENTS.
THE EFFECTS OF CANNABIS USE ARE
OBSERVED IN CANCER PATIENTS WITH
REGARDS TO CANCER THERAPIES AND
MEDICATIONS USE INFORM SYMPTOM
MANAGEMENT IN A LOT OF THE
BIOLOGICAL EFFECTS OF CANNABIS
USE DURING CANCER TREATMENT.
SO STUDIES SUBMIT TODAY THIS
INCLUDE WELL DESIGNED
PERSPECTIVE COHORT STUDIES OF
CANCER PATIENT COMPARED TO THOSE
USING CANNABIS TO THOSE NOT
USING.
OBTAIN DETAILED INFORMATION NOT
JUST ON PATTERNS OF CANNABIS AND
PATIENT DEMOGRAPHICS, CLINICAL
DISEASE CHARACTERISTICS AND THEY
OTHER USE PATIENT SYMPTOM
SURVEYS THAT MEASURE SYMPTOM
PREVALENCE AND SEVERITY OVER
SEVERAL TIME PERIODS AND IN
ADDITION, PROPOSALS COULD
COLLECT BIOLOGICAL SPECIMENS
SUCH AS BLOOD AND THERE'S A
RANGE OF POTENTIAL OUTCOMES THAT
APPLICANTS CAN LOOK AT INCLUDING
QUALITY OF LIFE, SYMPTOMS,
MEDICATION REDUCTIONS, SURVIVAL
OUTCOMES, AND BIOMARKERS OF THE
EFFECT SUCH AS LIVER, KIDNEY AND
INFLAMMATORY MARKERS.
THERE'S A NED TO PROVIDE FUNDING
TO SUPPORT PROJECTS AT THIS TIME
FOR SEVERAL REASONS.
WE HAVE AN AWARD ANY GRANTS ON
THE BENEFIT OR HARMS OF CANNABIS
USE IN CANCER PATIENTS FOR AT
LEAST SIX YEARS.
AND THERE'S A REAL URGENT NEED
TO COLLECT THIS INFORMATION TO
INFORM CLINICAL TRIALS AND THE
RFI WOULD ENSURE FUNDING OF
DIVERSE POPULATIONS ACROSS
DIFFERENT U.S. STATES, CARE
SETTINGS, CANCER SITES, STAGES
AND OUTCOMES AND THE
CO-OPERATIVE AGREEMENT ALLOW
SUBSTANTIAL INVOLVEMENT TO
ENHANCE RESEARCH COLLABORATIONS
ACROSS STUDIES THROW SHOWING
SURVEYS, DATA AND RESOURCES AND
THIS INITIATIVE WOULD ALLOW FOR
SPECIALIZED SCIENTIFIC REVIEW
WITH EXPERTISE IN THE CLINICAL
EPIDEMIOLOGY OF CANNABIS AND
CANCER RESEARCH.
SO WE'RE ASKING FOR FOUR-AWARD
GRANTS OF FIVE YEARS AND ONE U24
OVER A PERIOD OF FIVE YEARS.
AND THIS FUNDING IS STARTED IN
FISCAL YEAR '23 AND GOES FOR
FIVE YEARS THROUGH FISCAL YEAR
'27 FOR A TOTAL COST OF
$20.5 MILLION.
NEXT SLIDE.
WITH A VERY GOOD MEETING WITH
OUR BSA SUBCOMMITTEE AND I WANT
TO THANK THEM FOR THEIR I
INSIGHTFUL COMMENTS.
IF YOU HAVE A FEW QUESTIONS ON
PATIENT REPORTED OUTCOMES AND
WE'LL EMPHASIZE THE RFA A
PATIENT CENTERED APPROACH WITH
FOLLOW-UP AND PROs COLLECTED
OVER A PERIOD OF TIME AND A
QUESTION ABOUT WHAT WE MEANT BY
BIOLOGICAL MEASURES OF EFFECT
AND WE REALLY REFERRED TO
BIOLOGICAL MECHANISMS OF ACTION
POTENTIALLY EFFECTING CANCER
THERAPY SUCH AS LIVER, KIDNEY,
FUNCTION, AND INFLAMMATORY
MARKERS WE ARE NOT EMPHASIZING
THE MEASURE OF CBD OR THC FOR A
NUMBER OF REASONS ALTHOUGH THAT
IS CERTAINLY POSSIBLE.
AND THERE'S A QUESTION ABOUT WHY
AREN'T WE FUNDING CLINICAL
TRIALS RIGHT NOW?
AND THERE ARE A NUMBER OF
SIGNIFICANT BARRIERS TO THE
INITIATION OF CANNABIS CLINICAL
TRIALS IN CANCER AND WE FEEL
THAT OBSERVATIONAL STUD SEIZE
REALLY A FIRST STEP RIGHT NOW TO
INFORM WHAT THE RELEVANT END
POINTS ARE, WHAT THE APPROPRIATE
PATIENT POPULATIONS ARE, WHAT
ARE THE POSSIBLE HARMS INCLUDING
CANNABIS AND USE DISORDER AND
REALLY TO UNDERSTAND THE
POTENTIAL CANNABIS PRODUCTS,
DOSES, DELIVERY METHODS, THAT
SHOULD BE TESTED IN FUTURE
TRIALS.
THIS IS A QUESTION ABOUT DO WE
INCLUDE SURGICAL PATIENTS IN
TREATMENT AND WE DO AS WELL AS
THOSE UNDERGOING RADIATION AND
SYSTEM THERAPY AND IT'S FOLLOWED
UP BEYOND THE INITIAL ACTIVE
TREATMENT TIME PERIOD.
WORE ALSO ENCOURAGING POPULATION
BASED RECRUITMENT AND WE KNOW
THAT MANY STATE REGISTRIES ARE
ALLOWED FOR RAPID CASE
ASCERTAINMENT AND WHAT WE REALLY
ARE INTERESTING HERE IS IN THE
DENOMINATOR AND UNDERSTANDING
WHERE THE PATIENTS ARE RECRUITED
FROM.
SO, JUST TO SUMMARIZE, THIS
INITIATIVE WOULD ASSESS HOW AND
WHY CANCER PATIENTS ARE USING
CANNABIS, IDENTIFY THE REAL
BENEFITS AND HARMS OF CANNABIS
USE, AND CONTRIBUTING EVIDENCE
TO CLINICIANS AND PATIENTS RIGHT
NOW AND PROVIDE THE CRITICAL
INFORMATION THAT WE NEED TO
DESIGN AND CONDUCT FUTURE
CLINICAL TRIALS.
I JUST WANTED TO REMIND
EVERYBODY THAT WE DID PUBLISH A
NO SEE FROM OUR INTEREST GROUP
ON BASIC BENEFITS OF CANNABIS
ACTION AND FOCUS ON CANCER
BIOLOGY, INTERCEPTIONS,
TREATMENT, RESISTANCE AND CANCER
SYMPTOMS.
AND THIS NOSI COMPLIMENTS IS
RFA.
THANK YOU FOR YOUR TIME AND I
WANT TO THANK THE SUBCOMMITTEES
AS WELL.
>> I JUST WANT TO THANK Dr.
FREEDMAN FOR SUCH A THOROUGH AND
OUTSTANDING PRESENTATION.
I WANT TO THANK MY COLLEAGUES
THAT SERVED ON THE SUBCOMMITTEE.
WE MET A SYNCHRONOUSLY SO I MET
SEPARATELY ABOUT Dr. FREEDMAN
AND THE TEAM AT NCI BUT I
REVIEWED ALL THE COMMENTS FROM
THE SUBCOMMITTEE MEMBERS.
IN GENERAL, THERE WAS TREMENDOUS
SUPPORT FOR THIS RFA AND WE KNOW
AND I THINK Dr. FREEDMAN MADE
A STRONG CASE FOR THE NEED FOR
GREATER UNDERSTANDING OF HOW
PATIENTS ARE USING CANNABIS,
WHAT CLINICIANS AND PATIENTS
NEED TO UNDERSTAND ABOUT THEIR
USE AND HOW WE CAME IN CLINICAL
TRIALS AND THEY'RE ALL REALLY
IMPORTANT TOPICS AND I THINK AS
BOB POINTED OUT THEY SHOWED
THERE'S RELATIVELY HIGH USE OF
CANNABIS AMONG PATIENTS
UNDERGOING ACTIVE CANCER
TREATMENT NEARLY A QUARTER OF
THE PATIENTS REPORTED USING
CANNABIS AND WE KNOW ALMOST
NOTHING ABOUT THE HARMS AND
BENEFITS OF THEIR USE AND THEY
THINK IT IMPORTANT BE LIMITED TO
OBSERVATIONAL STUDIES AND
ESPECIALLY GIVEN HOW LITTLE IS
KNOWN ABOUT CANNABIS USE AND THE
FACT THAT REGULATIONS AND THE
CAR GORIZATION OF CANNABIS AT
THIS POINT DON'T ALLOW FOR THE
RANDOMIZATION OF PARTICIPANTS TO
CANNABIS OR NON CANNABIS ARM.
I THINK THAT Dr. FREED MAN DID
HIGHLIGHTS THE COMMITTEE AND SO
I'LL SAY I THINK THAT THERE WAS
TREMENDOUS SUPPORT ACROSS THE
COMMITTEE IN SET AGO SIDE FUNDS
FOR THIS RFA.
I'LL DEFER TO MY COLLEAGUES ON
MY SUBCOMMITTEE.
>> I'LL GO.
>> FIRST AND FOREMOST THANK YOU
FOR INVOLVING ME AND I COULDN'T
GROW MORE WITH Dr. QURAN ADD CO.
I WANT TO HIGHLIGHT TWO
COMMENTS, ONE WAS THANK YOU
Dr. FREEDMAN FOR PUTTING THAT
IN.
80% OF CANCER PATIENTS WITH
SOLID TUMORS REQUIRE SURGICAL
INTERVENTION AND AT SOME TIME OR
THE OTHER AND IT GOES FROM
DIAGNOSIS, TREATMENT,
RECONSTRUCTION OR SOMETHING LIKE
THAT SO INTEREST ADDITIONALLY WL
FOR ONCOLOGY PATIENTS WE THINK
LONG-TERM CHEMOTHERAPY OR
SOMETHING LIKE THAT BUT WE WANT
TO BE CONSCIOUS OF THIS GROUP OF
PATIENTS THAT ARE ACTIVELY
GETTING TREATED BY SURGERY OR
RADIATION THAT MIGHT BE
CONSIDERED FOR THIS AS WELL.
THE SECOND POINT THAT I WANTED
TO MAKE QUICKLY IS THAT THE
ADDICTION POTENTIAL OF THESE
DRUGS DESPITE THEIR BENEFITS AND
I O OVERSEE GLAD WATT TRAINING
PROGRAMS AND ONE OF THE FASTEST
RISING TRAINING PROGRAMS IS
ADDICTION MEDICINE AND IN THE
NUMBER OF PATIENTS WE'RE SEEING
AND ON MY CAMPUS WE JUST STARTED
A ADDICTION MEDICINE FELLOWSHIP
LESS THAN A YEAR OR TWO AGO AND
WE'RE ALREADY INCREASING THE
SIZE OF THAT AND OVER ALL WE HAD
GOOD SUPPORT FOR THIS AND WE
JUST WANT TO KEEP THOSE TWO
THINGS IN MIND AND THANK YOU FOR
IN CONCLUDING ME.
>>
>> IT'S LEFT THE STATION AND IT
NEEDS TO CATCH UP DID HE TELL
PRACTICESLY BAD.
ONE COMMENT I WILL MAKE TO THIS
GROUP AND WE TALKED ABOUT THIS A
LOT IS MAYBE IT'S A QUESTION AND
I DO THINK THAT WE NEED TO BE
THINKING ABOUT CLINICAL TRIALS
AND IF WE GET INFORMATION FROM
ANY OF THE PROJECTS FUNDED BY
THIS WE NEED TO BE ABLE TO MOVE
ON CLINICAL TRIALS AND I'M
CURIOUS IF THERE'S LOGISTIC OUT
THERE AND FEDERAL REGULATION AND
I'M CURIOUS IS THERE ANYTHING WE
CAN DO AND THE BSA TO SORT OF
HELP BREAKDOWN THESE BARRIERS IN
PLACE WITH BEING ABLE TO DO
THESE TYPES OF CLINICAL TRIALS
IN TERMS OF THOSE REGULATIONS.
>> SO, I CAN TELL YOU THAT
THERE'S BEEN A LOT OF DISCUSSION
IN NCI AND ACROSS NI-AND WOVE
BEEN WORKING WITH OUR COLLEAGUES
AT NIDA ABOUT DEVELOPING WAYS TO
HELP INVESTIGATORS CONNECT THOSE
CLINICAL TRIALS AND THERE ARE
REGULATORY ISSUES AND ONE OF THE
BIGGEST ISSUE IS GETTING AN IMD
AND RECRUITING PATIENTS AND I
MEAN, Dr. COOPER FROM IMPOSE
YUM WHAT A BEAUTIFUL ARTICLE ON
THIS AND THERE'S A LOT OF ISSUES
AND I THINK THAT HAVING NCI AND
ENGAGE WITH ABOUT THIS IS GOING
TO BE IMPORTANT AND A LOT OF IT
IS FACILITATING THE RESEARCH AND
THERE'S A LOT OF REGULATORY
ISSUES THAT WE HAVE TO OVERCOME
AND WE SHOULD MAKE IT AS EASY AS
POSSIBLE FOR OUR INVESTIGATORS
TO GET THE CLASS ONE LICENSES
AND REGISTRATION AND TO KNOW HOW
TO DO IT AND SO THAT THEY GET
ACCESS TO THE TYPE OF PRODUCTS
AND THAT THEY NEED TO SO YEAH,
THERE'S A LOT TO BE DONE AND I
THINK THAT THIS IS THE FIRST
STEP BUT KNOW THERE ARE INTEREST
GROUPS THAT HAS A CLINICAL TYPES
AND WORKING GROUPS ON THIS AND
IT'S WORKING PASSION ATLY TO TRY
TO MOVE THAT FORWARD.
>> THANK YOU.
AND YOUR COLLEAGUES AND I WANTED
TO JUST ECHO WHAT Dr. BARKER
SHARED JUST INTERNALLY THE SPEED
OF THIS AND THE SURGERY URGENCY
OF THIS ISSUE WE TALKED ABOUT AT
OUR LAST JOINT MEETING.
I CAN TAKE THIS OFF LINE BUT IN
FISCAL YEAR 2020 A DOZEN NCI
COMPANIES GOT SUPPLEMENT THIS IS
THIS AREA AND WHERE THE PROJECTS
MIGHT BE, THANK YOU.
>> SO WE FUNDED THROUGH
SUPPLEMENTS 12 CANCER CENTERS
AND THEY'RE EACH GOING TO
COLLECT A THOUSAND CANCER
PATIENTS THAT ARE USE OF
CANNABIS AND PATTERNS OF USE AND
IT'S REALLY A CROSS SEXUAL STUDY
AND WE ARE USING WHAT WE LEARNED
ALREADY FROM PRELIMINARY DATA
AND HAVING INCOP RATED THAT INTO
THIS CONCEPT INCLUDING BEER
SEEING PREVALENCE RATES MUCH
HIGHER THAN ONE FOUR AND 24% AND
30% AND EVEN HIGHER THAN THAT
AND WE HAVEN'T ANALYSIS HASN'T
BEEN COMPLETED AND THERE'S
BUT THERE'S A LOT OF USE OUT
THERE AND THE TYPES OF PRODUCTS
THAT THEY'RE USING AND HOW
THEY'RE USING IT WILL BE
INFORMATIVE AND TO MOVE BEYOND
THE CROSS SECTIONAL DESIGN TO A
COHORT DESIGN COLLECTING HARMS
AND BENEFITS.
>> THANK YOU FOR THE QUESTION.
I DON'T SEE ANY FURTHER HANDS.
>> I'M VERY SUPPORTIVE OF THIS
BUT I WANTED TO RACE WHAT MIGHT
BE FROM A LAY PERSPECTIVE SEEING
THE OBVIOUS MIX MESSAGE IF YOU
LOOK THAT THE RFA AND THE
PREVIOUS ONE AND SO IN THE
PREVIOUS RFA WE'RE SAYING YOU
KNOW, ADOLESCENTS SMOKING CAUSES
CANCER AND SO DON'T DO IT AND
THIS RFA WE'RE SAYING, WHEN THEY
GET CANCERS LIGHT UP.
IT'S OK.
SO HOW CAN WE, WHAT IS THE RIGHT
MESSAGES THAT MAY IN FACT BE THE
CASE AND I UNDERSTAND ONE
THOUGHT WOULD BE CAN WE
EXPLICITLY, I KNOW IN THE LAST
RFA, IT WAS MENTIONED, IT WAS
MAINLY TOBACCO BUT IT WAS ARE
PART OF THIS SO MAYBE WE CAN
EXPLICITLY LINK IT TO THE PREF
RFA AS WELL AS THE TITLE AND
IT'S A FINE MESSAGE.
>> MAYBE IT'S JUST WORKING
TOGETHER TO MAKE SURE THE
MESSAGING WAS ON POINT.
>> ABSOLUTELY.
>> I THINK WE CAN MOVE TO
VOTING.
GLORIA, DO I MAKE A MOTION.
>> I WOULD MOVE TO APPROVE.
>> SECOND.
>> ANY FURTHER DISCUSSION?
MOTION FOR APPROVAL.
LOCKING FOR ANY VOTES OF
DISAPPROVAL?
BY RAISE OF HANDS OR VOICE.
ANY A ABSTENTIONS?
I SEE NONE.
>> IT'S UNANIMOUS.
>> VERY GOOD.
MOVING ALONG, NEXT IS ANOTHER
RFA CONCEPT CANCER SCREENING
RESEARCH NETWORK TO EVALUATE
MULTI CANCER EARLY DETECTION
ASSAY FOR CLINICAL UTILITY IN
CANCER SCREENING.
Dr. CASTLE WILL BE PRESENTING.
SO CHAIRED SUPPORTED BY Dr.S
AND GO AHEAD.
>> THANK YOU.
HELLO AND THANK YOU FOR THE
OPPORTUNITY TO PRESENT THIS
CONCEPT TO YOU AND I'M
PRESENTING ON BOW HALF OF THE
DCP AND THE CLINICAL TRIAL TEAM
AND MANY OF WHOM ARE HERE
INCLUDING COLLEAGUES FROM THE
FDA AND I'M STANDING IN FOR LORI
WHO LEADS THIS PROJECT WHO IS
JOINING BY PHONE FROM LONDON.
THERE ARE TWO COMPONENTS TO THIS
PROPOSAL AND THE ESTABLISHMENT
OF A CANCER SCREENING RESEARCH
NETWORK INFRASTRUCTURE AND THE
FIRST STUDY WE WANT TO CONDUCT
IN THIS NETWORK OF FEASIBILITY
STUDY FOR THE MULTI CANCER EARL
DETECTION OR MCED AND THIS IS A
RIGHT TIME FOR BOTH, GIVEN THE
CALL FOR THE WHITE HOUSE FOR
IMPROVING CANCER PREVENTION AND
SCREENING AND THE CHALLENGES
ASSOCIATED WITH CANCER SCREENING
AND THE EMERGENCE OF
TECHNOLOGIES AND THANK YOU TO
TRAY, SIL VOW A VE SIL VOW A ANL
AND WE ARE GRATEFUL TO DCP AND
NETANTHENCI.
THIS IS OUR TSUNAMI SLIDE AND
THE NEED FOR THE IT WAS CAN
COMPANIES ENTERING THE MULTI
DETECTION SPACE AND THIS IS NOT
A COMPREHENSIVE LIST AND IT IS
AN EMERGING SPACE.
SOME OF THE COMPANIES, THE
CANCERS THEY TARGET AND
BIOMARKERS THEY USE ARE SHOWN IN
A SUPPLEMENTAL SLIDE ONE.
LET'S JUST SAY THAT THERE'S A
LOT OF PRESSURE THAT IS BEING
EXERTED TO INTRODUCE THESE
TECHNOLOGIES BEFORE DO YOU
DILIGENCE HAS BEEN DONE.
THE DEVELOPMENT OF THE NETWORK
INFRASTRUCTURE TO CONDUCT CANCER
SCREENING CLINICAL TRIALS AND
OTHER IMPORTANT SCREENING
STUDIES IS ONE PURPOSE OF THE
INITIAL EFFORTS IS TO CONDUCT
THIS FEASIBILITY CALLED THE VAN
GUARD STUDY IN REPARATION FOR A
LARGE RANDOMIZED CONTROL TRIAL
OR RCT TO EVALUATE TECHNOLOGIES
OR ASSAYS FOR THE PURPOSE OF
CANCER SCREENING.
WITHOUT CLINICAL BENEFITS SUCH
AS MORTALITY REDUCTION AND
POTENTIAL HARMS AND MORBIDITY DO
YOU TO TREATMENT OF DISEASE AND
USING ASSAY FOR CANCER SCREENING
AND HOW BEST TO SCREEN FOR
MULTIPLE CANCERS WITH DIFFERENT
LATEN SEE AND HOW IT COORDINATE
CARE AFTER A POSITIVE TEST
RESULT AND WE WOULDN'T THINK
ABOUT RECOMMENDING A DRUG
WITHOUT CAREFUL EVALUATION OF
ITS EFFICACY AND SAFETY
ESPECIALLY IN THE GENERALLY
HEALTHY POPULATION SO WHY WOULD
WE DO IT FOR SCREENING AND THEY
ARE DONE OUTSIDE THE BODY BUT
THE DOWNSTREAM EVALUATION AND
SCREEN POSITIVES ARE IN VIVO AND
THERE ARE HARMS ASSOCIATED WITH
IT.
NEXT SLIDE, PLEASE.
AND TRIALS ARE NODED TO EVALUATE
STRATEGIES THAT AIM TO REFINE
RISK STRATIFICATION OF IMAGING
FINDINGS AND DETERMINE WHEN TO
DEFER BUY ON TEE, LUNG CANCER
AND PULMONARY, BREAST CANCER,
AND DOWNGRADING TO BI-ADDS 3 AND
ACTIVE AND LOW GRADE CANCER AND
TRIALS ARE NEEDED TO EVALUATE
RISK STRATIFICATION FOR
SCREENING.
AND THE USE OF RISK SCORES LIKE
PRS TO GUIDE WHO NODES
SCREENING, HOW FREQUENTLY AND
HOW TO MANAGE A POSITIVE SCREEN,
AND MODIFY THE STARTING AGE FOR
SCREENING MODALITY LIKE
COLORECTAL SCREENING AND
STANDARD AGE SCREENING FOR COL
OLE RECTAL.
THE APPROACH AND RATIONED ALL
FOR CSRN DCP HAD A CSRN IN
COLLABORATION WITH QUESTIONS
RELATED TO CANCER SCREENING
CONTINUING WITH CARE AND
EFFICACY EFFECTIVENESS BEST
PRACTICES AND ADOPTION AND
ADAPTION AND IMPLEMENTATION FOR
EACH STEP IN THIS CONTINUUM.
CANCER SCREENING TRIALS REQUIRE
HEALTHCARE PROVIDERS OTHER THAN
ONCOLOGIST AND WE'RE DEALING
WITH HEALTHY POPULATION WHO'S
DON'T HAVE CANCER AND SCREENING
IS MUCH MORE THAN A TEST ITSELF
AND CANCER SCREENING IS A
PROCESS INVOLVING MULTIPLE
STEPS?
NON CON ONCOLOGY.
THESE ARE PRIMARY CARRYING
GASTRO WHO ARE EXPERTS IN CANCER
SCREENING.
AND THE SITE INVESTIGATORS TO
CONTRIBUTE SCIENTIFICALLY TO THE
DESIGN OF THE TRIAL OR TRIALS
IDENTIFYING AND IMPLEMENTING
WORK FLOW AND DIAGNOSTIC WORK
FOR CANCER SCREENING FOR
POSITIVE MCED TESTS AS WE'LL
HIGHLIGHT LATER THE COMPLEXITIES
ARE QUITE STAGGERING AND
ASSESSING THE HARMS AND ADVERSE
EFFECT AND OTHER UNEXPECTED
ISSUES AND WE NODE A
CONTEMPORARY COMMUNICATION IN
RECRUITMENT STRATEGY IN TRIAL
AND LOCAL LEVEL COMMUNICATION
RECRUITMENT EFFORTS.
NEXT SLIDE, PLEASE.
ESTABLISHING THE INFRASTRUCTURE
OR THE OBJECTIVES TO ESTABLISH
AN INFRASTRUCTURE NEEDED TO
IMPLEMENT SCREENING RCTs AND
OTHER STUDIES OF SCREENING
MANAGEMENT FOR PREVENTION AND
INCOMPETENTER EXCEPTION AND
WE'RE GOING TO START WITH THE
VAN GUARD STUDY AND CONDUCT
CANCER SCREENING TRIALS FOR
EMERGING TECHNOLOGIES FOR CANCER
SCREENING AND CONDUCT CLINICAL
UTILITY TRAILS.
AS YOU KNOW, YOU APPROVED EDRN
FOR ANOTHER ROUND AND BIOMARKERS
ARE GOING TO CONTINUE TO EMERGE
FROM EDRN AND WE NEED A PLACE IN
A STRUCTURE TO EVALUATE THEM.
CONDUCT CANCER SCREENING STUDIES
TO EVALUATE OTHER ASPECTS OF
CANCER SCREENING AND INCLUDING
CLINICAL WORK FLOW AND
COORDINATION OF CARE AND
ADAPTION IN IMPLEMENTATION OF
SCREENING STRATEGIES FOR DIVERSE
PRACTICE SETTINGS AND RISK
INFORMED SCREENINGS AND
MANAGEMENT AND PRAGMATIC TRIALS
OF SCREENING.
NEXT SLIDE, PLEASE.
THIS OUTLINES THE ORGANIZATIONAL
STRUCTURE OF THE CSRN AND
THERE'S A FIGURE COMING UP THAT
WILL ALSO EMPHASIZE THIS AND WE
ARE UTILIZING THE NCI CLINICAL
TRIALS ENTERPRISE SYSTEM AND IT
WILL MAKE THIS A LOT EASIER AND
WE'LL HAVE A COORDINATING AND
COMMUNICATION CENTER THAT WILL
PROVIDE CANCER SCREENING
LEADERSHIP AND OPERATIONS AND
COORDINATION FOR DEVELOPMENT AND
CONDUCT OF TRIALS AND STUDIES
AND COMMUNICATIONS FOR
RECRUITMENT AND RETENTION
EXPERTISE AND PROTOCOL
DEVELOPMENT AND MONITORING
AUDITING AND TRAINING AND A ONE
GRANT FOR A DATA MANAGEMENT AND
STATISTICAL CENTER AND PROVIDING
STATISTIC EXPERTISE FOR STUDY
DESIGN AND ANALYSIS AND DATA
MANAGEMENT WITH THE BIO
REPOSITORY.
NEXT SLIDE, PLEASE.
THEN THERE WILL BE 10 TO 15UG1
GRANTS THAT WILL BE THE ACCRUAL
IN SCREENING SITES ARE ACCESS
SITES AND INITIALLY THERE WOULD
BE 10 TO 15UG1 FUNDED CSRN SITES
IF WE LAUNCH THE RCT FOR THE
MCED TRIALS, WE NODE MORE SITES
BUZZ OF THE NUMBER OF PEOPLE WE
NEED TO RECRUIT AND THE 10 TO 15
WILL BE THE BASE CSRN NETWORK
AND YES, WE'LL LOOK FOR
INVESTIGATORS WITH EXPERTISE AND
CANCER SCREENING AND HISTORY OF
RECRUITING PARTICIPANTS ON TO
SCREENING AND PREVENTION
CLINICAL TRIALS AND STUDIES AND
INSTITUTIONS WITH DEMONSTRATED
PARTICIPANTS ON DISEASE
SCREENING CLINICAL TRIALS AND
ESPECIALLY CANCER SCREENING OR
PREVENTION.
HEALTHCARE SETTINGS, ACADEMIC,
COMMUNITY, HEALTHCARE SYSTEMS
AND PRACTICE-BASED RESEARCH
NETWORKS AND MOST IMPORTANTLY
DEMONSTRATED HISTORY OF
RECRUITING UNDERSERVED
POPULATIONS AND HAVING A
RECRUITMENT STRATEGY TO ACHIEVE
THAT.
NEXT SLIDE, PLEASE.
AND THIS JUST SORT OF OUTLINES
WHAT I JUST SAID.
HERE YOU CAN SEE THE
COORDINATING COMMUNICATION
CENTER AND THE DATA MANAGEMENT
AND STATISTICAL CENTER
COORDINATED WITH THE 10 TO 15
ACCRUAL SITES AND A STEERING
COMMITTEE OVERSEEING ALL OF THAT
AND THERE WOULD BE A WEB PORTAL
FOR PARTICIPANT USE AND WE'LL
HAVE A PARTICIPANT ADVISORY
COMMITTEE UP FRONT AT THE VERY
BEGINNING.
NEXT SLIDE, PLEASE.
WE'VE DONE A PORTFOLIO ANALYSIS.
MANY OF YOU ARE AWARE OF THE RO1
CLINICAL TRIALS GRANT PROGRAM
AND CLINICAL TRIALS EVALUATING
OPERATIONAL CHARACTERISTICS FOR
CANCER EARLY DETECTION
TECHNOLOGIES AND COMMUNICATIONS
AND RO1 EVEN IN A LARGE RO1 AND
THE ENCORE WHICH IS OUR OUR KEY
PROGRAM AND DCP AND A SUCCESS
ONCOLOGY AND OUR CHALLENGE
THAT'S EXIST AND PATIENT AND
CERTAIN TYPES AND IT'S REALLY
MEANT TO COMPLIMENT AND OTHER
TECHNOLOGIES THAT THE PIPELINES
THAT WE SUPPORT AND DISCOVERY
AND WE HAVE SEEN AN EX PANNING
NEED TO CONDUCT SCREENING TRIALS
TO ESTABLISH EFFICACY AND
BENEFITS TO RATIO IN THE GENERAL
POPULATION AND IT'S BEST
RECRUITED BY NON ONOLOGIST.
NEXT SLIDE, PLEASE.
COOPERATIVES AND INTER AND THE
USE OF EXISTING CLINICAL TRIALS
INFRASTRUCTURE AND A CTSU AND
CIRB AND CTIS AND MONITORING AND
AUDITING AND PROTOCOL REVIEW
PROCESS AND TRACKING AND AND
STATISTICAL METHODS AND ON THE
DATA AND FROM THE VAN GUARD AND
RESOURCE ALLOCATION AND FUNDING
TO ENSURE ADEQUATE RESOURCES FOR
THE OTHER LARGE TRIALS WE SEE IN
THE FUTURE.
AND AND PLEASE AND AND EARLY
TENSION AND WHAT HAPPENED AND
WHEN IN THE BLOOD AND MANY
MACKERS IN DEVELOPMENT AND
PATTERNS OF DNA METHYLATION AND
ET CETERA AND EACH MSET AS SET
AND AND IT'S A POSITIVE TEST
RESULT IS A SIGNAL FOR CANCER
BUT DOES NOT DIAGNOSE CANCER AND
SOME TASK SUGGESTION AND AND
POSITIVE MCED RESULT AND SOME
ASSAY COMPANIES TO REFINE AND
RESULT AND NEXT SLIDE, PLEASE.
THERE MANY MANY UNKNOWN AND
EARLY DETECTION ASSAYS AND
UNKNOWN SCREENING THE POPULATION
OF ASYMPTOMATIC PEOPLE FOR
CANCER WITH ASSAYS WITH A
MORTALITY REDUCTION FROM AND
UNKNOWN AND WHAT KINDS OF
DIAGNOSTIC AND NEEDED TO CARE
AND POSITIVE MCED TEST YOU DO
FIND CANCER AND HOW MANY PEOPLE
WOULD BE SUBJECTED TO UNNESS AND
COMPLICATIONS FROM THOSE
PROCEDURES AND REAL PEOPLE STOP
STANDARD OF CARE SCREENING AND
POSITIVE TEST AND BLOOD TEST
MAKE A SCREENING MORE ACCESS
ABLE AND AND WHETHER THOSE TESTS
NED TO OVER ZOO -- IT WAS NCI SF
PROVIDEDDED RATIONAL AND TRIAL
IN THE FEEDBACK WAS AND EXPERTS
THAT NCI NEEDS TO ASSAY FOR
CLINICAL BENEFITS AND ON THE
NODE FOR RIGOROUS AND
UNDERSTANDING HARMS FROM MCED
ASSAY AND CONDUCT A STUDY TO
ASSESS FEASIBILITY RANDOMIZATION
AND THE CLINICAL WORK FLOW FOR
DIAGNOSTIC PATHWAY AND NEXT
SLIDE, PLEASE.
WE DID PUT OUT A REQUEST FOR
INFORMATION SO YOU PUT FROM
DEVELOPERS AND READINESS IS TO
PARTICIPATE IN SPONSORS EX
UTILITY AND TRIAL AND IT WAS
REALLY IN JANUARY 2021 AND 2022
AND MARCH 21 TO 222 AND WE'VE
HAD 18 RESPONSES AND AND OUR
ASSAY DEVELOPERS OF VARIOUS
TECHNOLOGIES AND ONE REQUEST TO
BE A PARTICIPANT AND TWO
EXAMPLES OF EMERGING AND WE ARE
IN THE PROCESS OF MEETING WITH
THESE COMPANIES ONE-ON-ONE AND
THERE'S BEEN OTHER COMPANIES
THAT NECESSARILY AND IN THIS
DISCUSSION AND ABOUT A TRIAL AN-
>> THIS IS WHAT THE VAN GUARD
STUDY LOOKS LIKE AND THIS THROW
ARMS AND WE HAVE IT WRITTEN HERE
BECAUSE THEY HAVE DIFFERENT
MANAGEMENT ALGORITHMS AND SO IT
MADE SENSE TO HAVE A COUPLE OF
THEM HERE TO UNDERSTAND WHAT THE
LOGISTICS AND THIS IS GETS ON
RANGE OF POSITIVE AND HOW
VARIABLE THAT IS AND THE
OBJECTIVES AND RANDOMIZED AND
HEARINGS TO TESTING AND
DIAGNOSTIC FOLLOW-UP AND
EVALUATE FEASIBILITY OF PROTOCOL
DIAGNOSTIC WORKFORCE AND
DETERMINE AND BLOOD SPECIMENS
AND SO IDENTIFY FACILITATORS AND
AND PARTICIPANT AND GROUPS AND I
THINK AND ACTUALLY LED TO
IMPORTANT AND THE CONTROL
TRIALS.
NEXT SLIDE, NEEDED TO SUFFICIENT
NUMBERS OF SCREEN POSITIVES AND
ASSAYS TO DETECT SEVERAL OTHER
AND CANCER AND EXISTING ASSETS
AND 1% ARE RESULTING IN POSITIVE
AND DIAGNOSTIC RESOLUTION AND
ONE OF THE MAIN OBJECTIVES OF
THE VAN GUARD STUDY IS THE
APPROACH TO THE DIAGNOSTIC
PROCESS AND COLLECTION OF DATA
AND SO WE ESTIMATE 8,000 PERSONS
PER ARM AND 164 SCREEN POSITIVES
AND IT WAS AROUND DIAGNOSTIC
RESOLUTION AND SHOWN THE LEVEL.
NEXT SLIDE, PLEASE.
THE RANDOMIZED CONTROL TRIAL
DESIGN IS NOT IS DISSIMILAR FROM
VAN GUARD BUT IT'S A DIFFERENT
SUBSET OF CANCERS AND SO WE'LL
BE COMPARING THOSE BASICALLY
AGAINST THE STANDARD OF CARE AND
THAT IF WORE PLANNING ON TWO TO
START WITH BUT AS OTHER
TECHNOLOGIES EMERGE WE COULD ADD
ADDITIONAL ARMS IF YOU HIT NEXT
YOU WILL SEE THAT SHOW UP HERE.
NEXT.
THERE YOU GO.
AND THEN THE POINTS THIS IS SOME
OF THE DISCUSSION WITH OUR
REVIEWERS AND VAN GUARD HAS
FEASIBILITY AND FINALIZE DESIGN
LOGISTICS AND TO ASSESS BENEFITS
HARMS AND GENERALIZABILITY OF
THESE TEST AND I'M WORRIED THESE
TESTS WON'T WORK THE SAME IN
POPULATIONS THAT ARE UNDER
REPRESENTED IN SOME OF THE DATA
THAT GENERATED THESE BIOMARKERS.
AND WE ARE ASSAY AGNOSTIC AND
BOTH FROM THE BIOMARKER
PERSPECTIVE AND THE COMPANY
PERSPECTIVE AND MULTI-ARM
PLATFORM DESIGN ALLOW DROPPING
TESTED AND NOT PERFORM WELL AND
ADDING NEW ARMS FOR PROMISING
NEW TESTS AND DATA SHARING
ACCORDING TO THE FAIR PRINCIPLES
WILL BE REQUIRED AND WE'LL HAVE
. REPOSITORY WHICH WILL HAVE
VALIDATION OF NATURAL HISTORY
STUDIES AND COMPREHENSIVE
CHARACTERIZATION OF TUMOR
POTENTIALLY AT MOLECULAR STAGES
IN STATES WE'VE NEVER OBSERVED.
SO THIS WILL CATALYZE NEW
INTERCEPTION THERAPEUTIC
DEVELOPMENT IT'S SUPPLEMENTAL
BUT I CAN'T REMEMBER AND I
APOLOGIZE FOR THE TYPO, NEXT
SLIDE, PLEASE.
IT'S $73.5 MILLION OVER THE FOUR
YEARS TO GET STARTED.
NEXT SLIDE, PLEASE.
AND I'LL WRAP-UP WITH THE SLIDE
HERE.
WHICH IS THE MCED CLINICAL
TRIALS TEAM AND I JUST WANT TO
SAY THAT RECENTLY CMS
REPRESENTATIVES ARE JOINED AND
MANY OTHERS HAVE CONTRIBUTED AND
THEY'RE NOT LISTED HERE ASK TECH
TRANSFER IS NOW INVOLVED AND
THIS IS JUST ONE OF THE TEAMS
THAT IS WORKING ON THE TRANCE I
CAN'T SAY ENOUGH ABOUT THIS
DREAM TEAM AND IT'S AN HONOR AND
PRIVILEGE TO WORK WITH THIS ON
THIS PROJECT AND I APPRECIATE
THEIR HARD WORK AND GOOD HUMOR
AND I WANT TO THANK THEM AND
THANK YOU.
NEXT SLIDE.
AND AS NIL STATED THERE'S A
NUMBER OF THESE OVER THE LAST
COUPLE OF YEARS MARKETED AS DTC
TO CONSUMER PRODUCTS AND NOT A
LOT OF SUBSTANTIAL OVERSIGHT AND
SO THAT SECRETARY MOTIVATION AND
THE PANEL WHO IN ADDITION TO
MYSELF WERE SYLVIA AND MICHAEL
AND WE WERE UNANIMOUS IN THAT WE
THOUGHT THIS WOULD HAVE A HIGH
LIKELIHOOD OF ESTABLISHING THE
INFRASTRUCTURE AND ACHIEVING ITS
GOALS AND WE ALSO WANTED TO MAKE
IT CLEAR THAT THE PROGRAM THAT
PHILLIP HAS DESCRIBED HAS
MULTIPLE PARTS AND YOU COULD
CALL IT PARTS OR THREE PARTS
THAT THE FIRST PART IS THE
NETWORK OF CENTERS AND IT
ESTABLISHED THE INFRASTRUCTURE
FOR EVALUATING AND IF THEY WERE
SUCH AND WITH A MORE AMBITIOUS
SCOPE.
AS PHILLIP DESCRIBED, WE HAD A
VIGOROUS DISCUSSION IN THE
REVIEW PANEL AND SO I'LL
SUMMARIZE FOUR MAJOR POINTS MADE
THERE AND LET OTHERS ON THE
PANEL, SYLVIA AND MICHAEL CHIME
IN AS NEEDED.
BUT I WANT TODAY GO AHEAD AND
MAKE SURE THAT FELLOWSHIP I
WILL, I THINK LARGELY, YOU KNOW,
NOT COMPLETELY BUT LARGELY I
THINK HAZARDED THESE IN HIS
PRESENTATION SO ONE WAS WHILE
THERE WERE DETAILS WE WANTED TO
MAKE SURE THE OVER ARCHING, NOT
TO LOSE THE FOREST OR THE TREES
AND MAKE SURE THE OVER ALL
GENERAL GOAL OF AND LONG-TERM
POTENTIAL TO IMPROVE THESE
SCREENING PLATFORMS AND PATIENT
HEALTH WAS NOT LOST AMONG THE
TECHNICAL DETAILS AND I THINK IN
A SLIDE THAT HE CERTAINLY MADE
SOME CHANGES TO FOCUS ON THE BIG
PICTURE SO THAT WAS GREAT.
WE THOUGHT FURTHER DETAILS IN
THINKING, EVEN AS YOU SOLICIT
THESE DIFFERENT PROPOSALS
FURTHER DETAILS ON THE EXACT
KINDS OF WOULD BE GOOD IS OTHER
TYPES OF DATA BEING CONSIDERED
AND CERTAINLY CIRCULATING TUMOR
CELLS WERE MENTIONED AND WHAT
ABOUT OTHER FORMATS?
AND THE THIRD SET OF SUGGESTIONS
I'LL LET MICHAEL CHIME IN
BECAUSE HE CERTAINLY LED THOSE
POINTS DURING THE DISCUSSION.
THEY ALL RELATE TO DATA AND ALSO
ALGORITHMS SO IN WHICH PUBLIC
ROW POS TORIES WILL BE SHARED IN
A WAY THAT IS FIND ABLE AND
ACCESSIBLE AND INTER OPERABLE
AND REUSABLE, SHOULD WE SEEK NOT
ONLY TO EVALUATE THE SPECIFIC
MARKERS BUT ALSO THE
COMPUTATIONAL ALGORISMS THAT USE
THOSE MARKERS THAT IS TWO
DIFFERENT THINGS.
YOU COULD HAVE TWO ALGORITHMS
WITH THE SAME OR OVERLAPPING
SETS OF MARKSERS THAT MAY HAVE
DIFFERENT EFFICACY SO MICHAEL
CHIME IN AND THEN FINALLY, WE
THOUGHT THAT IT WAS OBVIOUS LOW
IMPORTANT TO COLLABORATE WITH
THE FDA ON THE SCREENING TESTS
AND THAT SAID, IT WAS PHILLIP
ASSURED US AND IT WAS GO AHEAD
TO SEE HE AND OTHERS REACHED OUT
TO FDA AND MEMBERS OF THE FDA
HAVE BEEN INVOLVED IN THIS
DESIGN OF THIS RFA CONCEPT.
SO WITH THAT I WILL LET MY CO
COMMITTEE MEMBERS CHIME IN.
>> I'M HAPPY TO.
>> SO THAT WAS REALLY GREAT.
YOU REALLY CAPTURED OUR
DISCUSSION.
I JUST WANT TO HIGHLIGHT A FEW
THINGS THAT WERE MENTIONED AND I
THOUGHT PHIL'S PRESENTATION WAS
REALLY GREAT TOO.
FIRST, I APPLAUD THE NCI -- I
THINK THIS IS CRITICAL AND WE
HAVE TO DO THIS AND THESE FIRST
FEW STEPS ARE REALLY IMPORTANT
AND VERY WELL THOUGHT OUT AND I
GROW IT'S A DREAM TEAM AT THE N.
CI.
THE LANDSCAPE IS COMPLICATED AND
I'D LIKE TO HEAR MORE FROM THE
NCI ABOUT THIS PUBLIC-PRIVATE
PARTNERSHIP WORKING WITH
COMPANIES.
AND THERE ARE COMPANIES THAT ARE
WINNING BIG TRIALS AND THEY'RE
PUTTING HUNDREDS AND BILLIONS
AND IT'S MORE COMPLICATED IN THE
SCREENING AND SO I'M JUST
THINKING THAT WE NEED TO REALLY
THINK AHEAD ABOUT THE COMPLEXITY
WITH ALTERNATIVE TRIALS UNDERWAY
AND AND THESE, THE TYPES OF
SAMPLES AND THESE TRIALS
GENERATE AND GENERALLY NOT SURE
AND SO I WOULD LIKE TO
UNDERSTAND HOW THAT POLITICIANS.
ON THE OTHER HAND BOTH AS AN
ENTREPRENEUR AND AS A CANCER
BIOLOGIST AND PATHOLOGIST AND I
THINK THIS IS IMPORTANT WORK TO
GET REAL SCIENCE DONE AND THAT
IS BROADCAST FROM.
>> Provost McMahan: THE FOR
PROFIT SECTOR TO CREATE RATIONAL
TEE SO I'M REALLY ENTHUSIASTIC
ABOUT THIS AND I'D LIKE TO SEE
HOW OF THOSE TWO IMPORTANT
ASSETS OF NCI ARE RECYCLE TO USE
AND OTHER PROGRAMS AND PHIL,
YOU'VE DONE A GREAT JOBGE ATG TD
WE WANT TO SEE THIS FUNDED AND
I'M ENTHUSIASTIC ABOUT IT AND I
WANT TO MAKE IT NEEDS TO
INTEGRATE BETTER WITH ITS OWN
SELF GOING FORWARD AND I AGREE
THE OUTREACH HERE IS SPECTACULAR
SO THANK YOU FOR THE SUMMARY AND
IT'S GREAT TO HAVE YOU HERE ON
THE BSA.
>> LET ME ADDRESS THESE
IMPORTANT TOPICS.
WE JUST RAN OUT OF SLIDES IN
TIME IN THE SUPPLEMENTAL SLIDES
WE GAVE A LIST OF 14 OF MAYBE 30
COMPANIES WITH DIFFERENT
TECHNOLOGIES AND THEREBY OWE
MARKERS AND WE CAN PUT THAT UP
IF YOU WANT AND ALSO, SOME DATA
ON THE MANAGEMENT ALGORITHMS AND
THE CHALLENGES OF DIAGNOSTIC
RESOLUTION.
COMING TO MICHAEL'S POINT, THE
COMPANIES USED SOME I FORGET
WHAT A RANGE WILL YOU LET'S SAY
FIVE TO 10 MILLS OF BLOOD.
IT'S OUR INTENTION TO BANK THE
BLOOD BECAUSE -- SO THERE'S
MULTIPLE TECHNOLOGIES THAT CAN
BE SUPPORTED BOTH BY THE TRIALS
ITSELF AND AS WELL AS THE
REPOSITORY SO I THINK THERE'S
GOING TO BE A LOT OF LEFTOVER
BLOOD.
YOU KNOW, YOU CAN COLLECT IF I
RECALL CORRECTLY SOMEONE CORRECT
ME IF SAY SOMETHING WRONG UP TO
60 MILLS.
AND I WOULD SAY IT'S OUR HOPE
AND OUR INTENTION TO
CHARACTERIZE ALL THE TUMORS THAT
ARE FOUND THIS THIS STUDY
BECAUSE AND ACCORDING TO GO THE
FAIR PRINCIPLES AND IN TERMS OF
THE COMPANIES, I DON'T KNOW THAT
THEY'RE GOING TO SHARE
INDIVIDUAL BIOMARKERS.
SO I DON'T KNOW THAT THEY'RE
GOING TO LET YOU INTO THE BLACK
BOX OF THEIR ALGORITHM AND
THEY'RE GOING TO DO THAT AND
PERHAPS I'M WRONG AND PERHAPS
OTHERS COULD WEIGH IN AND WHEN
YOU GET INTO INTELLECTUAL
PROPERTIES YOU CAN BE CHALLENGED
TO YOU HOLD THAT BAR HIGH LIKE
THAT AND THEY DON'T PARTICIPATE
AND WE'VE DONE A DISSERVICE
BECAUSE WE HAVE NOT EVALUATED
THE CLINICAL ASPECT AND WE KNOW
ABOUT THE POSITIVE RESULT AND
THE TOO BUT WE MAY NOT KNOW THE
SPECIFIC BIOMARKER THAT TURNED
ON AND.
>> LET'S KEEP THE PACE UP AND
IAN YOU ARE NEXT.
>> JUST A FEW THINGS.
THANK YOU FOR YOUR COMMENTS AND
KUDOS TO PHIL AND LORI AND WHICH
WE HAVE DONE THIS FOR PSA40
YEARS AGO HAD WE DONE SO WE
WOULDN'T BE WHERE WE ARE TODAY
AND WE'VE LEARNED SOME.
SO, I IT MAKES YOUR BRAIN HURT
TO DESIGN THIS TRIAL AND
THINKING ABOUT THE STAND AR OF
CARE AND THE TASK FORCE STANDARD
OF CARE OR THE OTHER OPTIONS.
AND I THINK THAT I MADE COMMENTS
ABOUT CO-OPERATIVE GROUPS AND
PCBT AND SELECT WERE PREVENTION
TRIALS BUT THEY ACTUALLY WERE
DIAGNOSTICS, AS YOU KNOW.
SO, IT CAN BE DONE WITH
CO-OPERATIVE GROUPS AND I WOULD
ENCOURAGE YOU TO ENCLOUD THEM
BECAUSE WE'VE BEEN THERE AND
WHEN I SAY WE IT'S ALL THE
GROUPS AND THE WOVE DEALT WITH
THIS AND LEARNED HOW TO DO IT
AND HOW NOT TO DO AND I WOULD
JUST ENCOURAGE THE MOST
IMPORTANT AND I KNOW EVERYONE ON
THIS GALLERY AND IS THINKING
ABOUT IT IS A VERY FEARFUL
ATTENTION TO MORBIDITY.
COMPLICATIONS OF DIAGNOSIS,
COMPLICATIONS OF TREATMENTS AND
DIFFERENTIAL RATES OF THESE
BASED ON THE POPULATIONS
THEMSELVES AND THE NUMBER, IT'S
NOT RUNNING THIS IT'S THE BOY
ASS THAT CAN BE THAT CAN MAKE
THEIR WAYS INTO THIS AND
UNDERSERVED POPULATIONS
HISTORICALLY ARE LESS LIKELY TO
HAVE DIAGNOSTIC TESTS AND LESS
LIKELY TO BE TREATED AND THERE
ARE DIFFERENCES THAT MAY BE TEST
RELATED SO LONG-TERM FOLLOW-UP
OF THE SIDE EFFECTS,SPECIALLY RS
THAT CAN SHOW UP 30 YEARS LATER.
SO, I KUDOS TO YOU BUT IT REQUIS
A LOT OF THOUGHT AND A LOT OF
THE EXISTING INFRASTRUCTURE AND
WITHIN THE NCI AND THAT YOU SO
CAREFULLY BUILT UP AND IT CAN
HELP AND PASS.
THANK YOU.
>> THANK YOU.
>> THANK YOU, WE SPOKE A LOT
ABOUT THE THOUGHTS I HAD.
THIS IS REALLY IMPORTANT.
THE APPROACH THAT CHRIS AND YOUR
TEAM HAS BUILT UP IT'S KUDOS TO
YOU AND I THINK THE IMPORTANCE
OF NCI DOING THIS WORK IS
UNREASONABLE AND AND THE
CLINICIAN AND IT'S IN THIS CASE
AND METHODOLOGY AND DELIVERY OF
CANCER SCREENING AND IN THIS
SPACE OF NOT KNOWING WHETHER
IT'S RIGHT OR WRONG AND I THINK
TO YOUR POINT, IAN, THIS REALLY
SHOULD ALSO PASS A U.S.
PREVENTATIVE TAX FORCE CRITERIA
AND IT'S A EFFECTIVENESS AND NOT
ABOUT THE EX SPEED YEN SEE OF
GETTING THIS IN TO MARKET SO WE
CAN MAKE MONEY AND I REALLY
ENCOURAGE NCI TO TAKE THIS ON AS
A AND INVOLVE THE POPULATIONS
THEY CAUSE MORTALITY AND
PANCREATIC CANCER AND LUNG
CANCER AND WE HAVE A TEST AND WE
CAN DO MUCH BETTER AND THE TEST
WE HAVE CURRENTLY ARE NOT IDEAL
AND I WISH WE HAD AN IDEAL TEST
BUT THERE ARE A LOT OF GAPS.
FALSE POSITIVES AND NEGATIVES SO
THEY'RE IMPROVEMENT IN THIS AND
SO I THINK THERE'S REALLY
IMPORTANT OPPORTUNITY TO GET IT
RIGHT AND AGAIN, REINFORCING AND
PHIL'S POINT WE ARE DOING THIS
ON ASYMPTOMATIC PEOPLE AND SO
MAKING SURE AND AND IT'S ABOVE
EX FFOR TEASE OF THAT GROUP.
THANK YOU.
>> FIRST, PHIL, YOUR SCIENCE IS
SPECTACULAR AND THIS IS
ABSOLUTELY NEEDED AND I WORRY
ABOUT THE PSA THING AND IT MAY
BE THE HORSE IS ALREADY OUT OF
THE BARN BECAUSE.
>> DAN: COMPANIES ARE ALREADY
MARKETING THIS AND I ASK YOU
BRING THE CO-OPERATIVE GROUPS IN
BECAUSE THOSE CO-OPERATIVE
GROUPS HAVE DONE SOME AMAZING
WORK IN SOME LARGE PREVENTION
TRIALS ALREADY AND THEY DO HAVE
SOME GENERAL HEALTH
PRACTITIONERS WHO ARE NOT CANCER
SPECIFIC DOCTORS WHO ARE RECRUIT
INTERESTING THAT AND IT MAY BE
FOR ECONOMIES OF SCALE.
THESE ARE UNDER THE CO-OPERATIVE
GROUPS ARE UNDER RESOURCED AND
HERE IS MONEY YOU ARE GOING TO
SPEND, MAYBE YOU CAN SPEND THAT
MONEY ON THE CO-OPERATIVE GROUPS
AND BEEF THEM UP A LITTLE BIT
AND HELP.
WE'VE HAD SOME INTERESTING
CONVERSATIONS IN THE CHAT HERE
ABOUT MINORITY ACCRUAL.
DIVERSITY IS ESPECIALLY
IMPORTANT HERE BECAUSE YOU CAN
DO A GREAT DEAL OF GOOD RISK
ASSESSMENT AND I DID SAY
SOMETHING A LITTLE CONTROVERSIAL
AND I'M A LITTLE WORRIED WORE
GOING TO GRAB IN FQHCs AND
CREATE DISPARITIES IN THESE
UNDER RESOURCED FQHCs FOR
THINGS OTHER THAN CANCER BY
CONSUMING TIME ON THE CT
SCANNERS AND OTHER THINGS SO IF
WE DO GO TO THESE CENTERS, WE
NEED TO MAKE SURE THEY'RE
ALREADY RESOURCED SUCH THAT THEY
COULD PROVIDE AND AMONGST IT'S
20 YEARS AND TO LET'S GIVE
DIVERSITY BUT LET'S NOT CREATE
DISPARITIES AT THE SAME TIME.
>> CONGRATULATIONS.
>> I AGREE WITH YOU.
IT WAS ONE OF THE VERY FIRST
THINGS WE DISCUSSED IS WHEN WE
STARTED TO THINK ABOUT THIS
TRIAL IS WE HAD TO MAKE SURE IN
OUR THINKING THAT THERE WOULD BE
POTENTIALLY UNDER INSURED OR
UNINSURED PEOPLE THAT WOULD BE
IN THIS TRIAL AND THAT WE HAD TO
GUARANTEE AND I EMPHASIZE
GUARANTEE THE FULL CARE AND SO
THAT WAS UNDERLINING PRINCIPLE
FROM THE VERY BEGINNING AND WE
WILL ADHERE TO THAT AS YOU KNOW
I WOULDN'T LEAVE IT BEHIND.
AS EXCITING AS THESE
TECHNOLOGIES ARE WE NEED THEM TO
WORK FOR EVERYBODY AND RECOGNIZE
SOME OF THE DOWNSTREAM ISSUES
THAT UNDER SERVE POPULATIONS ARE
PREDISPOSED TO.
>> I MIGHT HAVE MISSED IT AND I
APOLOGIZED IF I DID.
DO YOU HAVE A SYSTEMATIC PROCESS
TO EVALUATE AND SELECT
BIOMARKERS FOR STUDY.
I DIDN'T HEAR ABOUT IT BUT I
WELL MAY HAVE MISSED IT IN THE
PRESENTATION?
>> WELL, WORE NOT ASSESSING
BIOMARKERS, WE'RE ASSESSING TEST
AND THESE TESTS ARE PANELS.
WE'RE AGNOSTIC ABOUT THE PANEL
OR THE COMPANY OR THE TECHNOLOGY
THEY HAVE TOE GO THROUGH AND
EVALUATE AND WITH A REFERENCE
SET THAT IS ESTABLISHED BY BEING
ESTABLISHED RIGHT NOW BY THE
ALLIANCE AND THEN ONLY THEN CAN
THEY EVEN BE CONSIDERED FOR THE
FEASIBILITY STUDY AND THEN THEY
HAVE TO PASS THE FEASIBILITY
STUDY CAN WE ACTUALLY USE THAT
AS SAY IN A RANDOMIZED CONTROL
TRIALS BEFORE THEY EVER EVEN CAN
BE CONSIDERED AND THAT IS WHAT
WE HAVE SO FAR IF YOU HAVE OTHER
SUGGESTIONS ABOUT HOW WE HOLD
THEIR FEET TO THE FIRE, I'M
HAPPY TO HEAR IT.
>> THANK YOU.
>> GREAT AND THIS IS AMAZING AND
I GUESS WITH THE SUBSTANTIAL
INVESTMENTS BEING PUT NO THIS
THOUGH I SAW THE MENTION OF .
REPOSITORY AND IS THAT GOING TO
BE CENTRALIZED OR A SET ASIDE
BUDGET AND JUST SEEING A RICH
OPPORTUNITY TO REALLY MAKE SURE
THAT YOU STAND SOMETHING UP THAT
IS ROBUST AND IT'S IMPORTANT TO
MAKE SURE THE RESOURCES ARE
THERE.
>> ANDY, THAT WAS AN IMPORTANT
PART OF OF DESIGN AND WE'LL SEND
OUT THE RIDES OR THE SLIDES WILL
BE SHARED BUT THIS IS IF THESE
WORK THEY'LL FUEL MANY OTHER
DEVELOPMENT AND SO CREATING THIS
BIO REPOSITORY AND
CHARACTERIZING THE TUMORS, WE DO
FIND IS CRITICAL THIS AND I
REFERRED TO THIS IN THE PRIVATE
MEETING WITH THE REVIEWERS IS
OUR LUNAR LANDING AND I'M NOT
QUITE EVEN SURE WHERE IT WILL
GO, IF THOSE TECHNOLOGIES WORK
AT ALL.
WE'LL HAVE TO SEE AND EVALUATE
THEM.
>> THE COLLECTION OF LIFESTYLE
DATA AND DIETARY COMPARISON AND
THAT AND IT IS ADDED AT THE LAST
MINUTE AND IT SHOULD BE
INCORPORATED AT THE LAST MINUTE.
>> I AGREE WITH YOU.
>> FIRST YOU OF ALL THIS IS WO.
THE WHOLE GROUP THAT WORKED ON
THIS AND I THINK THERE'S NO
QUESTION THAT WE NEED A CANCER
SCREENING THAT WORKS AND I KNOW
THERE'S BEEN SOME DISCUSSION
ABOUT RELATIONSHIPS WITH THE
CO-OPERATIVE GROUPS AND THEY
KNOW HOW TO DEVELOP THE NETWORKS
AND THEY HAVE DONE IT TIME AND
TIME AGAIN WITH ALL THE
CONVERSATIONS WE'VE BEEN HAVING
ABOUT THE IMPORTANCE OF
SCREENING THE BIGGEST
CONTRIBUTION WILL BE THE
INFRASTRUCTURE THAT WILL BE SET
UP THAT WILL INVOLVE THE PRIMARY
CARE PHYSICIANS ALL OF THESE
FOLKS THAT YOU GUYS ARE TALKING
ABOUT IN THE HEALTH CENTERS THAT
DO THIS TYPE OF SCREENING IN
ADDRESS THIS ON A DAY TO BAY
BASIS IN THEIR WORK AND EVEN
THOUGH WE'VE DONE SUCCESSFUL
PREVENTION AND SCREENING STUDIES
IN ENCORE, WE STILL STRUGGLE
EVEN AFTER MORE THAN A DECADE OF
TRYING AND TO REALLY ACTIVELY
ENGAGE THESE FOLKS AND IN THE
DESIGN AND THE CONDUCTS AND THE
LEADERSHIP OF THESE TRIALS AND
WHEN YOU THINK ABOUT THAT, THE
REASON YOU WANT THEM LEADING
THESE TRIALS IN THIS NETWORK TO
BE SET UP, IS BECAUSE THEY'RE
GOING TO KNOW THE RIGHT
QUESTIONS TO ASK AND THEY'RE
GOING TO HAVE ACCESS TO THE
PATIENTS AND THEY'RE GOING TO BE
THE ONES THAT ARE AS SOON AS WE
SEE THE RESULTS OF THESE TRIALS
THEY'RE GOING TO BE ABLE TIME TT
THE NEXT DAY SO KUDOS TO THIS
GROUP.
I CAN'T SAY ENOUGH ABOUT MAKING
SURE THIS MOVES FORWARD AND I
ALSO THINK THAT I WILL JUST ADD
THAT CONVERSATIONS WITH FOLKS IN
THE CO-OPERATIVE GROUPS FIT
NORTH KIND OF CONVERSATIONS THAT
WOULD ALLOW THESE NETWORKS TO
COMMUNICATE, I DO THINK IT WOULD
BE VERY BENEFICIAL BECAUSE I
THINK THEY'LL BE SOME TYPES OF
SCREENING STUDIES THAT WILL
STILL BE NEEDED IN THOSE
NETWORKS, FOR EXAMPLE, PATIENTS
WHO ARE ALREADY SCREENING HIGH
GENETIC RISK WHO ARE FOLLOWED BY
AN ONCOLOGIST SORRY PERHAPS
PEOPLE WHO ARE BEING SCREENED
FOR ONSET OF SECOND CANCERS
AFTER A CANCER TREATMENT.
THIS IS ADDRESSING A HUGE GAP
AND I JUST WANT TO REITERATE MY
SUPPORT AND THANK YOU FOR THIS
EFFORT.
>> THANK YOU, KAREN FOR THE
GENEROUS WORDS AND WE ARE
TALKING TO THE CO-OPERATIVE
GROUPS ABOUT HIGH-RISK
POPULATIONS FOR MCED BECAUSE
THEY WOULD BE GOOD THROUGH THE
ENCORE AND OTHER MECHANISMS.
>> I'LL TAKE MY VIDEO OFF.
THIS IS SUCH AN INCREDIBLE
OPPORTUNITY BECAUSE THERE ARE
PEOPLE LIKE ME AND I'M SURE
MANY, MANY, MANY WHAT'S WOULD
LOVE TO GET ACCESS TO SEQUENCING
DATA AND SEQUENCING DATA FOR
THIS PURPOSE AND DEVELOPING THE
ASSAY SO THERE'S ALSO AN
OPPORTUNITY TO DO RESEARCH HERE
AND IN TERMS OF WHAT THAT
BIOMARKER PANEL SHOULD BE AND
I'M JUST WONDERING, IF AS YOU
TALK IT THROUGH, YOU DO -- THE
NCI DOES PAY FOR SEQUENCING DATA
IT'S CAPTURED IN THESE TRIALS IN
PARALLEL TO FOLKS CAN DEVELOP
ASSAYS BASED ON THE OUTCOMES SO
I'M JUST PUTTING IT OUT THERE
THERE COULD BE A PERIL
OPPORTUNITY.
>> GREAT POINT.
WE WILL FOLD THAT IN.
>> WE HAD ANNE WITH HER HAND UP
AND HOWARD HAD HIS HAND.
>> HIS HAND WENT DOWN SO I'M
HOPING THEY FELT THEIR QUESTION
WAS ADDRESSED.
>> I'M GOING TO BRING MINE UP IN
OPEN SESSION LATER.
>> VERY GOOD.
>> WE BROKE Ar A RECORD IN THE
COMMENTS IN THE CHAT AND ROBUST
COMMENTS ON THE FEDERALLY
QUALIFIED HEALTH CENTER SO IF
YOU COULD GRAB THOSE AND
INCORPORATE THOSE THAT WOULD BE
GREAT.
LET'S MOVE TO VOTING.
MOTION.
>> MOTION TO APPROVE.
>> SECOND.
>> ANY FURTHER DISCUSSION?
>> HEARING NONE.
MOTION IS FOR APPROVAL AND ANY
VOTES OF DISAPPROVAL?
ANY ABSTENTIONS?
>> IT'S UNANIMOUS APPROVAL.
>> VERY GOOD.
LET'S KEEP MOVING.
NEXT IS RFA TRANSFORMATIVE
EDUCATIONAL ADVANCEMENT AND
MENTORING NETWORK AND TEAM AND
Dr. LEANNE BAILEY IS
PRESENTING AND THE SUB COMMIT
SEE CHAIRED BY SUSAN BAKER AND
SUPPORTED BY MYSELF AND NELSON
CHOW AND DID PARTICIPATE IN OUR
GROUP DISCUSSION AND LOW AN, GO
AHEAD WITH YOUR PRESENTATION.
>> GOOD AFTERNOON, THANK YOU FOR
THE OPPORTUNITY TO PRESENT THE
CONCEPT OF -- THIS IS FOR TEAM.
I'M DELIGHTED TO PRESENT THE
TRANSFORMATIVE EDUCATIONAL
ADVANCEMENT AND MENTORING
NETWORK TEAM FOR THE REST OF
THIS PRESENTATION.
AND I'LL BE PRESENTING THIS
CONCEPT ON BEHALF OF THE THE
WORKING GROUP NUMBER 2 OF THE
NCI EQUITY COUNCIL.
NEXT SLIDE, PLEASE.
SO, AS YOU ALL KNOW, NCI IS A
BIG PLACE AND THIS SLIDE REALLY
DETICKETS OUR BREADTH AND DEPTH
IN THE RESEARCH AND TRAINING
OPPORTUNITIES THAT THE INSTITUTE
SUPPORTS.
NEXT SLIDE, PLEASE.
RECENT EFFORTS BY BOTH NCI AND
THE NIH ARE PROVIDING THE
OPPORTUNITIES TO INCREASE
DIVERSITY OF FUNDED CANCER AND
INVESTIGATORS THROUGH PROGRAMS
SUCH AS THE N.
>> Catherine: CONTINUING
UMBRELLA OF RESEARCH EXPERIENCES
AND THE PARTNERSHIP TO ADVANCE
CANCER HEALTH EQUITY AND THERE'S
A GAP IN RACIAL AND ETHNIC
MINORITIES AND THE SCIENTIFIC
ENTERPRISE AND WORKFORCE.
TARGETED LEVERS OF REALLY NEEDED
SPECIFICALLY TARGETED OUTREACH
TO MINORITY SERVING INSTITUTIONS
TO IDENTIFY AND ASSIST WITH THE
DEVELOPMENT OF UNDER REPRESENTED
SCHOLARS MIGHT BE QUITE
BENEFICIAL AND ONE OF THE
MECHANISMS THAT NCI HAS USED
OVER THE LAST FIVE YEARS IS
TRAINING NAVIGATION AND IT'S
HELPED FOR VALUABLE WHO TO SPEAK
TO AND HOW TO RESPOND TO THE
PEER REVIEW PROCESS.
SO, SOMETIMES SCHOLARS ARE
SUCCESSFUL AND THE FIRST TRY AND
VERY -- IN A SMALL MINORITY
HOWEVER MANY TIMES THEY HAVE TO
REAPPLY AND RESPONDING TO NOT
ONLY PEER REVIEW BUT ENGAGING IN
TERMS AND HAVING TO TAKE AND WE
FOUND THAT HAVING A QUALIFIED
EXPERT TO ASSIST AND FOCUSED ON
THIS PROCESS WAS HIGHLY
ADVANTAGEOUS AND THE TEAM
PROGRAM IS INTERESTED IN AN PRE
DOCTORAL POSTDOC TO BAL AND
EARLY STAGE INVESTIGATIVE CAREER
FUNDS IN THE PIPELINE AND NEXT
SLIDE, PLEASE.
SO, THE IPSOS-REID
CONSTITPERSONAL AND TRANCEFISSIE
GEOGRAPHIC MANAGEMENT OF CANCER
HEALTH DISPARITIES PROGRAMS.
SO TRAINING NAVIGATION EFFORTS
IN FY2019 AND 2020 RESULT INSIDE
SUCCESSFUL APPLICATION TO CURE
AND 36% IN 2019 AND 45% IN 2020
AND IN COMPARISON TO THE NIH
SUCCESS RATE OF 30% FOR BOTH
YEARS.
SO, LOCALIZED NAVIGATION SUPPORT
AT THE INSTITUTIONAL LEVELS IS
REQUIRED THAT SCHOLARS RECEIVE
THAT CONTINUOUS PERSONAL
TRAINING AND COORDINATION
EDUCATION AND SUPPORT.
AND THIS IS ESSENTIALLY THE
VISION OF THE TEAM PROGRAM.
NEXT SLIDE, PLEASE.
THE PURPOSE OF TEAM IS INFORM
PILOT TEST AND USE OF THESE
TRAINING CHAMPIONS AT NSI TO
PROVIDE EDUCATIONAL AND CAREER
DEVELOPMENT AND IN TERMS OF THE
NAVIGATION FOR UNDER REPRESENTED
SCHOLARS AND HERE YOU SEE THE
OBJECTIVES AND WE'LL DELVE INTO
THESE THREE OUT THE REST OF THE
AND AS I MENTIONED THE PILOT THE
USE OF TRAINING CHAMPIONS AND
THE SECOND OBJECTIVE IS REALLY
LEVERAGING THEM AND THE
INSTITUTIONAL SUPPORT TO CONNECT
A POTENTIAL SCHOLAR GROUP WITH
MENTORING AND NETWORKING
OPPORTUNITIES AND LASTLY A
DIDN'T ADOPTING EDUCATIONAL
ACTIVITIES.
TO PROVIDE AND EACH LEVEL
DISTINCT ROLLS AND POSSIBILITIES
AS DEFECTED HERE AND WE SEE THE
TRAINING AND THE LEAKY PIPELINE
BY SUPPORTING AND CONNECTING AND
INVESTIGATORS AS WELL AS MENTORS
AND WITHIN THE INSTITUTION AND
PROVIDE MORE GRANULAR AND
TARGETED SUPPORT.
SO, WE ENVISION THE TRAINING AND
ONE FULL TIME EQUIVALENT THAT
WOULD BUILT ON THE GROUND
SUPPORT TO THE SCHOLARS AND
ALTERNATIVELY THAT A TEAM OF
TRAINING AND THAT EQUALS
FULL-TIME EQUIVALENT AND THEY
MAY HAVE EX TENSE AVENUE AND
WORKING CAPABILITIES AT 25% OF
THE TIME AND 75% OF THE TIME
DEVOTED TO THE SUPPORT AND
PEOPLE WHO SUPPORT LOGISTICS AND
THE CONNECTIONS AND THE
TRAININGS AND PROVIDE
ADMINISTRATIVE SUPPORT AND THESE
INDIVIDUALS CAN BE PART THE
INSTITUTION AND THEY CAN ALSO BE
RECRUITED FROM EX CONTINUAL
OPTION AND SO THE CHAMPIONS WILL
HAVE THE FULL SUPPORT OF NCI
PROGRAMS AND THEY WILL RECEIVE
FORMALIZED TRAINING BE PART OF
THE TRAINING NAVIGATION THEM
THAT WILL BE HOUSED AT COCHD.
SO WE RECOGNIZE THAT IT'S
CRITICALLY IMPORTANT TO BE ABLE
TO INCLUDE NOT ONLY MENTORING
BUT ALSO NETWORKING
OPPORTUNITIES AND YOU WILL
THOUGH THE TEAM CONCEPT IS
CENTERED ON THE SCHOLARS
INDIVIDUAL GROWTH, WE ALSO
UNDERSTAND THE IMPORTANCE OF THE
COLLECTIVE AND THESE EFFORTS ARE
CAN'T BE CHAMPIONS JUST BY
INDIVIDUALS SO LONG-TERM
SUSTAINABILITY WILL HAVE SUPPORT
THAT LEVERAGES RE SOURCES AT THE
INSTITUTION LEVEL.
HE UNDERSTAND HOW IMPORTANT
GRANTS ARE IN THIS PROCESS AND
SO THAT WILL ALSO BE A KEY
OBJECTIVE FOR THIS ASPECT OF THE
GRANT.
SO THIS ENCOURAGES INNOVATION
AND WE'RE EXCITED ABOUT THE
OPPORTUNITY TO ADAPT OUR
LEVERAGE CULTURALLY TAILORED
EDUCATIONAL ACTIVITIES AND OR
SHORT COURSE THAT'S WILL ENHANCE
NOT ONLY SUBJECT MATTER
EXPERTISE AND CAREER DEVELOPMENT
AND GIVEN THE CURRENT STATE OF
THE CLIMATE AND RACISM AND WE'RE
REALLY WANT TO GO PROMOTE
EFFECTIVENESS MENTOR AND MENTEE
COMMUNICATION STRATEGIES AND
STRAIN SCHOLARS AND ETHICS AND
MIKE OWE AGGRESSION AND
STRUCTURAL INEQUITIES AND WE ARE
HOPEFUL THAT THIS OPPORTUNITY
WOULD PRESENT WITH ENGAGEMENT
STRATEGIES AND CROWDSOURCING AND
NETWORK SCIENCE TO OPTIMIZE THE
LEARNING FOR SCHOLARS.
SO REGARDING THE BUDGET WE
PROPOSE THAT UP TO FIVE R25 TEAM
GRANTEES WILL BE AWARDED AND THE
IT WOULD BE TO HAVE FIVE YEARS
WITH 300K IN DIRECT COSTS AND
500K IN TOTAL COSTS PER REWARD
PER YEAR AND THE BUDGET WITH
PHYSICAL CALECHES YEAR 2023 AND
2028.
AND ESTIMATED TOTAL COST PER
YEAR 2-POINT # # WITH ATTEMPT
COST FOR THE FI -- THIS ISPARTIT
TRAINING NAVIGATION ACTIVITIES
AND IN 2018, THEY CONNECTED WITH
THOSE COORDINATING THAT I
MENTIONED THROUGH GMAP AND THEY
WERE THROUGH TRAINING NAVIGATION
TO THE CONTINUING UMBRELLA AND
EXPERIENCE PROGRAMS AND AT THAT
POINT, MULTIPLE AWARDS WERE
CONSIDERED AND THE PERSON
APPROVED AND AFTER RECEIVING A
SUMMARY STATEMENT TO SUPPORT THE
ALSO MET WITH THE MENTOR AND IN
THIS PARTICULAR INSTANCE AND IT
RESULTED IN THE KO1 AWARD IN
2020 AS WELL AS A LOT OF PAYMENT
AWARDS AND WE FOCUSED ON NCI
OPPORTUNITIES WE WANT FOLKS TO
BE ABLE TO ENGAGE THE FULL
CAPACITY WITH REGARD TO
OPPORTUNITIES.
AND SO, WE WOULD LIKE TO
GRATEFULLY ACKNOWLEDGE THE
WONDERFUL DISCUSSION THAT WE
HAVE WITH OUR BSA REVIEWERS AND
A FEW OF THE POINTS OF
DISCUSSION ARE DETAILED ON THIS
PAGE AND I'M SURE THAT THEY WERE
GOING TO ADDITIONAL DETAILS AT
THE SUMMATION OF THIS FORECAST
PRESENTATION AND WE REALLY DO
APPRECIATE THE SUGGESTIONS AND
THE CLARITY THEY SUSPECTED THAT
THEY SUGGESTED ESPECIALLY WITH
REGARDS TO RFA AND I'D LIKE TO
ACKNOWLEDGE THE GROUP OF FOLKS
AND THE DEVELOPMENT AS WELL AS
MATURITY AND THE CONCEPT AND
BEFORE AND CONTEXT WITHIN THE
CHCDT TEAM AS WELL AS THE EQUITY
COUNCILOR AND SPECIAL
CONTRIBUTORS AND FROM OTHER
DIVISIONS AND AND I WOULD LIKELY
LIKE TO THINK AND THEY'RE
HELPFUL GUIDANCE AND BEING.
>> Connor: CHAMPIONS FOR
DIVERSITY SO WITH THAT I HAD
WOULD BE HAPPY TO CONCLUDE AND I
THANK YOU FOR YOUR TIME AND
ATTENTION.
>> GREAT.
SUZANNE, OPEN THE DISCUSSION.
>> SURE.
SO IT WAS A PLEASURE TO CHAIR
THE SUBCOMMITTEE ALONG WITH
Dr. FLARE TEE AND CHOW AND I
WANT TO THANK Dr. BAILEY FOR
BEING REALLY RESPONSIVE TO OUR
COMMENTS AND OUR DISCUSSION.
THE SUBCOMMITTEE DISCUSSED
TOGETHER BEFORE MEANING OF DOCK
BAILEY AND WE SENT OUR QUESTIONS
AND ADVANCE SO THAT SHE WAS VERY
WELL PREPARED FOR A PRODUCTIVE
DISCUSSION AND SHE FOLLOWED UP
WITH NICE SUMMARIES OF HOW SHE
WAS PLANNING TO ADDRESS THESE
POINTS AND SHE'S ALREADY REALLY
TOUCHED ON THE MAIN QUESTIONS
FROM THIS SUBCOMMITTEE AND THE
FIRST THING TO SAY IS THAT WE
WERE UNIFORMLY EXTREMELY
ENTHUSIASTIC ABOUT THIS VERY
IMPORTANT INITIATIVE SO CLEARLY
THIS IS VERY DESPERATELY NEEDED
AND WELL CONSTRUCTED AND SOME OF
THE ASPECT THAT'S WE THOUGHT
WERE PARTICULARLY PROMISING IS
CHANGES GOING BACK TO THE
EARLIER STAGES BECAUSE
EARLIER THAT THE GREAT BUILDINGS
A BIG PLUS ON THIS APPLICATION
AND THE STRUCTURE THAT IS
RELYING ON SOME PROGRAMS THAT
ARE STRONG AND ALREADY PUT IN
PLACE AND WE HAVE TO BE RELATED
TO THE CLARITY OF THE RFA AND
IT'S DESIGN WRITTEN IN A VERY
OPEN STYLE TO ENCOURAGE
CREATIVITY AND INNOVATION AMONG
THE APPLICANTS THAT I CAN COME
UP WITH CREATIVE IDEAS ON HOW
BEST TO LEVERAGE THE RESOURCES
AND WE THOUGHT IT COULD BE MADE
A LITTLE BIT MORE CLEAR TO THE
APPLICANTS THAT EXACTLY WHAT AN
APPLICATION MIGHT LOOK LIKE
PERHAPS BY GIVING A FEW EXAMPLES
OF PARTICULAR FORMATS OR WORK SO
THEY HAVE AN IDEA OF HOW TO PUT
THEIR APPLICATIONS AND TOGETHER
AND WE WERE NOT CLEAR EXACTLY
WHO THE TRAINING CHAMPIONS MIGHT
BE WHAT INDIVIDUAL WE THOUGHT IT
WAS A SENIOR AND WELL FUNDED
INVESTIGATOR AND Dr. BAILEY
POINTED OUT THAT THAT PERSON WAS
OUR CONCERN AND IT MIGHT NOT
REALLY CENTER THE TIME TO INVEST
AND THE PROGRAMS THAT THE WAY
YOU WOULD LIKE THEM TO AND SO
THEY PLANNED TO PUT IN A MORE
CLEAR DEFINITION OF THE
DIFFERENCE WAYS THOSE TRAINING
CHAMPIONS COULD BE STRUCTURED TO
BE MORE THAN ONE PERSON AND
PEOPLE WITH CREDENTIALS AND TO
ADD DETAILS ON THE SCOPE OF THE
PROGRAM MIGHT LOOK LIKE AND THAT
WOULD BE DIFFERENT AND THE
TRAINING LEVELS AND HOW MANY
SCHOLARS WOULD BE ENGAGE IN KIND
OF PROGRAMS THEY WOULD PUT
TOGETHER AND THIS WOULD BE SOME
DESCRIPTION AND CREATIVE
APPLICATIONS AND MAKING A LITTLE
BIT CLEAR AND EXACTLY WOULD BE
ABLE TO I'LL LEAVE IT THERE AND
IF YOU HAVE QUESTION AND.
>> JUST TO PUT AN EMPHASIS ON
THE FACT THAT WE'RE SO
ENTHUSIASTIC ABOUT THIS
INITIATIVE THAT I THINK IT'S TO
RESOURCES AND A SHAWL NUMBER OF
AWARDS THAT WILL BE OFFERED
WHICH CREATES A VULNERABILITY
WHICH IS THAT PER INSTITUTIONS
AND HE WAS AWARDED A GRANT AND
THEY'LL BE A TYPE OF EXPERTISE
THAT IS REPRESENTED IN THAT
PERSON AND THEY'RE CLINICAL AND
WITHIN EACH DOMAIN THERE ARE
MULTIPLE TIMES OF EXPERTISE AND
THAT ARE DISTINCT AND BE IT
DISCIPLINE OF CANCER CARE IN THE
CLINICAL SIDE AND EPIDEMIOLOGY
AND THE LIKE SO YOU CAN IMAGINE
VERY DISTINCT CHAMPIONS AND SO,
A POINT OF IS REALLY INTERACTIVE
WITH ADAPTABILITY ABOUT WAS
TRYING TO ENSURE THIS NETWORK
COMPONENTS RATES SO THAT
TRAINING IS WHO CAN BENEFIT FROM
CHAMPIONS AND IT MAY BE BASIC
TEST UNDER THE OS PISSES OF
EPIDEMIOLOGIST AND WHO IS VERY
FOCUSED ON CLINICAL RESEARCH
INTO THE SPECTRUM AND THAT
PERSON MIGHT BENEFIT FROM BEING
ABLE TO REACH OUT ACROSS
INSTITUTIONS SO PARTICULARLY IN
THE ERA OF THIS INITIATIVE ARE
GREAT HOPE OF COURSE IS THAT
THIS TAKES HOLD AND BEGINS TO
MULTIPLY AND WITHIN INSTITUTIONS
AND ACROSS THE NETWORKS SO
THAT'S JUST ONE ATTENTION TO
TRYING TO EMPOWER AND TYPE OF
APPROACH HERE AND IN THE EARLY
GOING.
>> THAT WAS ONLY A POINT I WANT
TODAY ADD.
LET'S OPEN UP TO DISCUSSION,
HOWARD I SAW YOUR HAND UP.
>> SURE.
>> SO THE IMAGES YOU SHOWED, YOU
KNOW, PORTRAY THIS ABOUT GRANTS
MAN SHIP FOR SINGLE GRANT
RECIPIENTS AND I THINK AS KEITH
STARTED TO SAY I THINK AS I
UNDERSTOOD HIS COMMENTS, THERE'S
A LOT MORE OPPORTUNITIES HERE
FOR MORE VALUES TO THE PATIENT
POPULATION AND HOW GRANTS
FUNCTION.
I'M THINKING ABOUT SOME OF THE
LIMITATIONS OF SOME OF THE
MODERN THERAPIES LIKE STEM CELL
THERAPY FOR DIFFERENT DISEASES
AND IT HAS BEEN START HE'D IN
TERMS OF HOW THEY FAIR WHEN THEY
GO FORWARD AND THERE HAVE BEEN
TIMES WHERE MENTORING THE THE
RUNNING IT HAS LED TO
IMPROVEMENTS AS THEY GO FORWARD
INTO LARGER POPULATIONS AND
THAT'S A BIG DEAL BECAUSE WE
CARE ABOUT GENERALIZABILITY OF
THESE SPECIFIC THERAPIES THAT
ARE OFTEN APPROVED WITH SMALL
SPECIAL INSTEAD OF THE SINGLE
GRANT RECIPIENTS, I SEE THAT A
LOT OF GOOD RESEARCH IS BY
TEAMS.
IT TAKES A VILLAGE AND IT HAS A
GROUP MENTORING PROGRAM WHERE
THEY BRING IN USUALLY A
BRILLIANT GUY WHO IS DONE A LOT
OF WONDERFUL GRANTS AND HE
TEACHES BASICALLY A COURSE THAT
ANYBODY WHO WANTS TO COME IN CAN
COME IN AND LEARN ABOUT
GRANTSMANSHIP AND ABOUT HOW IT
TAKES A VILLAGE AND HOW TO WORK
WITHIN THE VILLAGE AND THE
NURSES, THE CO-WORKERS AND
PHARMACISTS WHO ARE NEEDED TO
MANAGE GOOD GRANTS AND TRUCK
PITCH TEE.
>> I THINK THOSE ARE ALL
FABULOUS POINTS AND ONE OF THE
KEY COMPONENTS OF THE CONCEPT IS
TO DO JUST THAT AND YOU KNOW,
WITH THE INTRODUCTION OF COVID
AND HYBRID PLATFORMS AND THE
COMMUNICATIONS SOCIAL MEDIA THAT
CAN LEVERAGED AND WE'RE LOOKING
FOR MODELS AND INFORMATION CAN
BE READILY EXPORTED TO THE
COMMUNITY TO DO EXACTLY WHAT YOU
ARE SAYING.
AND TO IDENTIFY CHAMPIONS AND
MENTORS THAT WILL BE ABLE TO
PROVIDE THE GUIDANCE AND WILL BE
ABLE TO PROVIDE THAT CAD RAY OF
INDIVIDUALS.
I APOLOGIZE IF THE LAST SLIDE,
THE NEXT TO LAST SIDE THROUGH
YOU OFF WITH THE INDIVIDUAL
BECAUSE WE REALLY ARE WORKING TO
HAVE MULTIPLE TRAINEES WITHIN
THESE CADRAYS SO THERE WILL BE
EXTENSIVE COLLABORATIONS WITH
ACADEMIC MEDICAL CENTERS, CANCER
CENTERS, PERHAPS COMMUNITIES
LIKE WHATEVER IT IS THAT SITE
WANTS TO FOCUS ON.
>> THAT LIST YOU GAVE YOU DIDN'T
JUST SAY AND FARBETTER COMPANIES
WHO ARE KEEN ON SUPPORTING THESE
KINDS OF MENTORING PROGRAMS AND
AGAIN, THEY HAVE INTEREST IN THE
RUSE OF THEIR PRODUCTS BUT THEY
REALLY DO CARE ABOUT THE
SUCCESSFUL.
SEEING NO HANDS WE CAN MOVE TO
VOTING.
SUZANNE, WOULD YOU LIKE TO MAKE
A MOTION?
>> I MOVE TO APPROVE.
>> SECOND THAT.
>> ANY FURTHER DISCUSSION?
THE MOTION IS TO APPROVE.
ANY VOTES OF DISAPPROVAL.
YEAH, ANY ABSTENTIONS?
SEEING NONE.
PAULETTE.
>> WE'RE GOING TO GO.
IT'S UNANIMOUS.
>> FANTASTIC.
WE'RE NOT GOOD TO GO ON TIME SO
I DON'T THINK WE SHOULD TAKE A
10-MINUTE BREAK BUT WE PROBABLY
NEED TO GIVE PEOPLE A
FIVE-MINUTE BREAK OR BREAKING
SOME KIND OF FEDERAL CODE.
>> THERE'S NO FEDERAL CODE.
>> NO CODE BECAUSE WE'RE
GOVERNMENT EMPLOYEES.
>> YOU ARE BEING NICE.
YOU GIVE THEM FIVE MINUTES.
I WAS GOING TO LEAVE AND COME
BACK.
>> YES.
>> LET'S TAKE A QUICK
FIVE-MINUTE BREAK.
BACK AT 4:08.
SEE YOU ALL SOON.
>>WE HAVE ONE LAST NEW CONCEPT
FOR THE DAY.
THIS IS AN RFA, CANCER MOONSHOT
SCHOLARS DIVERSITY PROGRAM AND
IT WAS SUPPORTED BY DOCTORS AND
LEANNE, TAKE IT AWAY.
>> IT'S BEEN SO LONG SINCE WE
CONVEWECONVENED BUT I'M EXCITEDO
PRESENT THE CANCER MOONSHOT
SCHOLARS DIVERSITY PROGRAM.
THIS IS OUR OPPORTUNITY TO
DISCUSS IT.
BIOMEDICAL RESEARCH WORKFORCE
THAT CAPITALIZES ON THE SPECTRUM
OF THE NATION'S SKILLS, TALENTS
AND VIEW POINTS IS ESSENTIAL FOR
SOLVING COMPLEX HEALTH PROBLEMS
INCLUDING CANCER.
THE INVOLVEMENT OF INDIVIDUALS
WITH DIVERSE CULTURAL
PERSPECTIVES HAS BEEN SHOWN TO
BE ESSENTIAL AND ORDER TO REACH
SAID COMMUNITIES AND MAKE
ADVANCINGMENTS IN ADDRESSING
CANCER HEALTH DISPARITIES AND
THE NCI IN ALIGNMENT WITH NIH
AND THE WHITE HOUSE DEMONSTRATES
A STRONG COMMITMENT TO ENSURE
LONG-TERM SUCCESSES IN THE
CANCER RESEARCH ENTERPRISE.
SPECIFICALLY THE PROGRAM SEEKS
TO PROMOTE SCIENTIFIC ADVANCES
IN CANCER RESEARCH THROUGH THE
DIVERSIFICATION OF THE POOL
WITHIN THE PORTFOLIO TO FOCUS ON
EARLY STAGE INVESTIGATORS FROM
UNDER REPRESENTED GROUPS, AND AS
WELL AS TO INCREASE THE NUMBER
OF FUNDED RO1 INVESTIGATORS FROM
UNDER REPRESENTED GROUPS ACROSS
THE CANCER RESEARCH CONTINUUM.
INDIVIDUALS FROM UNDER
REPRESENTED GROUPS, BLACK,
AFRICAN AMERICAN, HISPANIC OR
LATINO OTHER GROUPS AND ASIAN
AND HOWEVER, THESE GROUPS ARE
DIS PURCHASE OR THE ATLY
REPRESENTED WITHIN THE NCI, RO1
PORTFOLIO.
THIS SLIDE SHOWS THE
DEMOGRAPHICS OF NCI'S FY-20
EQUIVALENT APPLICANTS AND THE
TOP ROW AND THE AWARDEES IN THE
BOTTOM ROW.
THE RESULTS SHOW THE NUMBER OF
AGGREGATE UNDER-REPRESENTED
GROUPS IS LESS THAN THOSE OF NON
UNDER REPRESENTED GROUPS NOT
HISPANIC WHITE AND ASIAN
APPLICANTS.
THE FIRST CHALLENGE HIGHLIGHTED
HERE IS THERE IS A DECREASE IN
THE NUMBER OF APPLICATIONS FROM
UNDER REPRESENTED GROUPS SUCH AS
BLACK AND AFRICAN AMERICANS.
AND THE SECOND IS ADDRESSING THE
FUNDING GAP WHICH LEADS TO A
LOWER REPRESENTATION IN NCI
AWARDEES IN COMPARISON TO THE
APPLICANT POOLS.
AND THIS FUNDING GAP WAS
OBSERVED BY IN 2011 FOR THE NIH
OVER ALL AND A PER PONDERANCE
CONFIRMS THAT IT CAN CONTINUES
AND SO THIS IS NOT SPECIFIC TO
N.
>> Catherine: IT'S A CHALLENGE
FOR NIH OVER ALL.
THIS DATA DEPEBBLES SOME OF THE
THE BIG.
>> THE CRY YEAR TA WILL BE
CONSISTENT WITH THE NIH
DIVERSITY STATEMENT AS LISTED
HERE.
AND I'M HAPPY TO REPORT THAT
THREE PUBLISHED FOAs THAT ALSO
ARE FOCUSING ON DIVERSE FEE
UTILIZED THIS CRITERIA AND THIS
DIVERSITY LANGUAGE HAS BEEN
APPROVED BY THE OFFICE OF THE
GENERAL COUNCIL.
TO CONTINUE WITH THE
ELIGIBILITY, OUR STAGE
INVESTIGATORS FROM UNDER
REPRESENTED GROUPS ARE
ENCOURAGING TO APPLY AND THERE
IS NO RESTRICTION AND
APPLICATIONS FOR PROPOSING
TOPICS THAT SPAN THE ENTIRE
CANCER CONTINUUM WILL BE
CONSIDERED NOT ONLY RESPONSIVE
AND ALSO ALIGNED WITH THE PAIR
OF RO1 PROGRAM ANNOUNCEMENT.
AND APPLICATIONS ARE PERMISSIBLE
HOWEVER, AN INVESTIGATOR FROM AN
UNDER REPRESENTED GROUP MUSTING
DESIGNATED AS THE CONTACT P.I.
AND AN INSTITUTIONAL ELIGIBILITY
LETTER MUST BE SUBMITTED BY THE
APPLICATION INSTITUTION CERTIFY
THE APPLICANT IS CONSIDERED TO
BE UNDER REPRESENTED.
AGAIN, FOR THE PURPOSES OF THIS
RFA, INVESTIGATORS ARE DEFINED
ACCORDING TO THE SOMETIMES OF
INTEREST IN DIVERSITY.
THE CANCER MOONSHOT SCHOLARS
DIVERSITY PROGRAM WILL BE LED BY
CRCHD WITH TRANS INPUT AND
PARTICIPATION FROM THE DIFFERENT
DIVISIONS OFFICES AND CENTER
ACROSS NCI.
THE TRANS NCI STEERING COMMITTEE
WILL WORK AS A TEAM AND TO
REVIEW ALL RO1 APPLICATION AND
ASSURE APPROPRIATE DOCK
ASSIGNMENTS DEPENDING UPON THE
REFERRAL GUIDELINES AND THE
STEERING COMMITTEE MEMBERS WILL
ADDITIONALLY CONTRIBUTE TO
OUTREACH ACTIVITIES TO ENSURE
THAT A BROAD RANGE OF APPLICANTS
ARE MADE AWARE OF THE FOA AND
THIS WILL INCLUDE A COMBINATION
OF TARGETED SOLICITATIONS AND TO
INSTITUTIONS AND GRANTEES AS
WELL AS A BROAD MARKETING
CAMPAIGN USING SOCIAL MEDIA AND
OTHER COMMUNICATIONS PLATFORMS.
SO LIKE THE APPLICATIONS WITHIN
EACH AREAS OF SCIENCE, BASED ON
MERIT, AVAILABLE FUNDING AND
OVER ALL NCI PORTFOLIO GAPS WILL
BE ANALYZED AND AS PREVIOUSLY
STATED THERE'S NO RESTRICTION ON
THE TYPE OF CANCER RESEARCH
BEING PROPOSED AND WE REALLY
SEEK TO ENSURE THAT THERE IS A
BALANCE REPRESENTATION FROM
BASIC CLINICAL, TRANSLATION AND
POPULATION SCIENCE.
NEXT SLIDE, PLEASE.
CANCER MOONSHOT FUNDS ARE BEING
REQUESTED TO SUPPORT THIS
PROGRAM AND THIS WILL BE A
THROW-YEAR ISSUANCE FOR FY2023
THROUGH '25 WITH SET ASIDE FUNDS
OF $9 MILLION IN TOTAL COSTS
EACH YEAR TO FUND NEW TYPE 1
AWARDS.
WE ANTICIPATE UP TO 15 NEW RO1
AWARDS PER YEAR AND 45RO1 TOTAL
TO BE FUNDED.
THIS REQUEST ESTIMATES THAT THE
AVERAGE RO1 IS 600K IN TOTAL
COSTS OR 350 IN K IN DIRECT
COSTS PER YEAR AND THE PROJECT
PERIOD CAN BE UP TO FIVE YEARS.
THE ESTIMATES TOTAL COST FOR THE
RFA PROGRAM IS UP TO 135 AND
MILLION TOTAL COSTS AND 78.75 IN
DIRECT COSTS.
THE ESI-RO1 APPLICATIONS WITH
SCORE EQUIVALENT OR BETTER THAN
THE NCI RO1 PAYLINE WILL BE
ELIGIBLE FOR THE TWO-YEAR
EXTENSION.
WE ARE CRITICALLY AWARE OF HOW
IMPORTANT THE METRICS WILL BE TO
ASSESS THIS PROGRAM AND SO IF
YOU EVALUATION CRITERIA ARE
LISTED HERE AND WE FULLY EXPECT
AN INCREASE IN THE NUMBER OF
EARLY STAGE INVESTIGATIVE
APPLICANTS FROM UNDER
REPRESENTED GROUPS AND IN THE
NCI, RO1 POOL AND EARLY STAGE
INVESTIGATORS AWARDEES FROM
UNDER REPRESENTED GROUPS IN THE
NCI/RO1 AWARD RULE AND LASTLY
THE MONITORING OF THE
PRODUCTIVITY OF THE FUNDING RO1
INVESTIGATORS AND THE NUMBER AND
QUALITY OF PUBLICATION AND
SCIENTIFIC PRESENTATIONS AND
SESSIONS WILL BE CRITICAL.
IN ADDITION TO THE SHORT TERM
MEASURES OF SUCCESS, WE ALSO
ANTICIPATE THAT THE RFA WILL
LEAD TO A SUN TAPED LONG-TERM
INCREASE IN DIVERSITY AND ALSO
TO INCREASE THE NUMBER OF UNDER
REPRESENTED GROUPS AND
LEADERSHIP POSITIONS AT VARIOUS
INSTITUTIONS AND THOSE THAT ARE
ENGAGE IN CANCER RESEARCH AND WE
ALSO ANTICIPATE THE MENTORING
THE GRADUATE STUDENTS POSTDOCS
AND NEW INVESTIGATORS BY THESE
NEW RO1 HOLDERS.
AND I WOULD LIKE TO GRATEFULLY
ACKNOWLEDGE THAT THE INSIGHTFUL
FEEDBACK IN COMMENTARY FROM OUR
BSA REVIEWERS AND IT WAS REALLY,
REALLY INSIGHTFUL AND I AM
PAIMPACTFUL.THERE WHY ITEMS THEL
ELABORATE ON WHEN THEY GIVE
THEIR REVIEW AND I'M SURE
THEY'LL HIGHLIGHT THOSE SHORTLY.
IN SUMMARY, I WOULD LIKE TO
POINT OUT THAT GREAT IDEAS LIKE
THIS ONE DON'T MATERIALIZE
OVERNIGHT OR IN ISOLATION.
THIS PROGRAM IS REALLY THE
CULMINATION OF MANY YEARS AND
AND THEIR SUPPORT AND
CONTRIBUTIONS OVER THE YEARS.
WHAT YOU SEE REFLECTED ON THIS
SLIDE IS REALLY THOSE WHO HAVE
BEEN ADD ROW VOW KITS AND THISM
COME TO WITH THAT I'M HAPPY TO
ANSWER QUESTIONS.
THIS IS A KIND OF PROGRAM THAT
IS REALLY IMPORTANT TRYING TO
PROVIDE PEOPLE WITH
OPPORTUNITIES AND A GROUP OF US
MET WITH LEANNE AND WE REALLY
HAD NO REAL THINGS TO MODIFY IT
WITH ORB ANYTHING.
>> THIS IS CRITICALLY NEEDED FOR
NUMBER WHO IS LOOKED AT FIGURES
OVER THE LAST 35 YEARS A IT
NEEDS TO BE LONGER AND MAYBE WE
CAN'T MAKE IT LONGER BECAUSE
WHAT WE ARE, IN ADDITION TO THE
OBVIOUS, FACING IS THE
DISCOURAGEMENT IN GENERAL FROM
MINORITY AND WE NEED TO BE
PREPARED TO EXTEND THIS BECAUSE
WE'LL NEED TO TALK TO THE
GRADUATE STUDENTS AND POSTDOCS
AND BRING THEM ALONG JUST SO YOU
DON'T NEED TO GO TO INDUSTRIES
AND YOU DON'T NEED TO GET TO
MEDICAL SCHOOL THERE'S A CAREER
PATH HERE.
SO WE NEED SUSTAINABILITY.
>> THIS IS INCREDIBLE.
I'M READY TO JUMP OUT OF MY
SEAT.
THIS IS LONG, LONG, LONG OVERDUE
OVER IN THE LAST COUPLE OF
DECADES, AS THE FUNDING LINE HAS
GOTTEN SMALLER AND SMALLER AND
CLOSER TO THE SINGLE DIGITS OF
FUNDING AT THE NCI AND YOU KNOW
THESE ARE THE INVESTIGATORS WHO
ARE GETTING SQUEEZED OUT AND IF
YOU ALL REMEMBER, I GUESS,
TEMPERATURES TWO DECADES AGO AND
THE MINORITY SUPPLEMENT STARTED
THAT WAS THE INTENTION OF THAT
WAS TO ADD THE MINORITIES ON TO
THE RO1s AND HOPEFULLY GET
THEM TO THE PLACE WHERE THEY
WOULD BE SUCCESSFUL AND GET A IT
DIDN'T HIT THE MARK AND THE LONG
RUNWAY IS REALLY IMPORTANT
BECAUSE THIS IS REALLY GOING TO
SOLIDIFY AND REALLY CLOSE SOME
HOLES IN OUR PIPELINE IF WE CAN
GET THE YOUNG INVESTIGATORS WITH
MORE 15RO1s IS AMAZING NUMBER
AND TO BE FUNDED PER YEAR AND IF
THOSE FOLKS HAVE LABS AND MENTOR
OTHER FOLKS IN THE 10 YEARS, WE
CAN MAKE ADVANCED THAT WE HAVE
NOT HAVE SEEN SO THE RETURN ON
INVESTMENT ON THIS IS GOING TO
BE TREMENDOUS AND THAT'S MY
COMMENT.
>> THANK YOU.
>> I'LL ECHO FANTASTIC.
MY QUESTION IS REALLY JUST FOR
CLARIFICATION, I REALLY LIKED
SEEING THE CONCEPT OF THE ESI
MULTI PI FOR THE RO1 AND
SOMETIMES ESIs CAN BE
DISADVANTAGED IF THEY GO MULTI
PI SO HOW ARE YOU THINKING ABOUT
THAT OR FOR THIS PARTICULAR
GROUP THAT WON'T MATTER AND THAT
IS IF THEY'RE THE CONTACT PI
THEY'RE THE CONTACT PI?
>> SO I'M HAPPY TO LET SOME OF
MY COLLEAGUES CHIME IN AND
DURING THE CONVERSATION, IT WAS
ARTICULATED THAT SOMETIMES,
UNLESS THERE'S A MULTI-P.I.
DESIGNATION FOR THE PERSON WHO
IS UNDER REPRESENTED, THAT THEIR
CAN BE PERHAPS LESS OF AN
OPPORTUNITY SO TO REALLY
ENCOURAGE OWNERSHIP AND REALLY
TO ENCOURAGE THEM DRIVING IT AND
SO THAT WAS THE REASON OR THE
THINKING BEHIND HAVING THAT
DESIGNATION AND IF OTHERS WOULD
LIKE TO CHIME INTO ADD SOMETHING
ELSE, FEEL FREE.
>> KIM, THIS IS DOUG.
I WANT TO TRY TO COMPLIMENT WHAT
LEANNE IS SAYING AND THE
PREPORTION OF THE OUR AWARDS
THAT ARE MULTI P.I. AWARDS, HAS
BEEN GOING UP YEAR BY YEAR AND
THEY NOW REPRESENT ALL IT'S NOT
A RANDOMIZED CONTROL TRIAL.
THAT ESIs WHO ARE PART OF A
MULTI-MPI AWARD HAVE, IN
GENERAL, MORE DIFFICULTIES
GETTING A INDIVIDUAL AWARD
SUBSEQUENTLY THAN PIs WHO HAVE
GOTTEN INDIVIDUAL AWARDS.
IT DOESN'T MEAN IT WILL HAVE TO
HAPPEN BUT I THINK THAT THE
NOTION THAT LEANNE IS TALKING
ABOUT, OF MAKING SURE THAT THE
ESI IS THE CONTACT PI HOPEFULLY
WILL GO SUBSTANTIAL WAY TOWARDS
HELPING NOT JUST WITH GETTING
THIS AWARD BUT SUBSEQUENT AWARDS
WHICH OF COURSE, WILL BE
MERIT-BASED.
>> GREAT.
THANK YOU.
>> I THINK I MISSED YOU.
SORRY ABOUT THAT.
YOU ARE MUTED I THINK.
KEITH, DID YOU JUST SAY MY NAME?
>> I'M SORRY, I WAS TRYING TO
GET EARL THE MIC.
I CAN'T HEAR YOU.
LET'S GO TO MELISSA REAL QUICK.
>> I JUST AM GOING TO ADD A
COUPLE THINGS.
FIRST OF ALL, LEANNE, THAT WAS
SO NEEDED TO HAVE AN EXTENSION
OR JUST TO HAVE THIS OPPORTUNITY
FOR THIS PROGRAM SO I WANT TO
THANK AND YOU THANK THE
COMMITTEE FOR ENDORSING THIS
BECAUSE I REALLY THINK IT'S
IMPORTANT.
IN MY DEPARTMENT, I'VE JUST
HIRED QUITE A FEW NEW SYSTEM
PROFESSOR WHO URM AND YOU KNOW
WE'RE GOING THROUGH THEM PUTTING
IN RO1s AND HAVING TEAM
SCIENCE EFFORTS AND I THINK
THAT'S WHAT PROBABLY WOULD
REQUIRE THEM TO HAVE MULTIPLE
INVESTIGATORS ON THIS AND I
ENCOURAGE OUR JUNIOR
INVESTIGATORS TO HAVE MULTIPLE
P.I.s BUT FOR THEM TO BE THE
CONTACT P.I., SO I THINK IT'S
WHY WE WOULD SEE THEM AND THEM
BEING THE CONTACT PI IS JUST
REALLY IMPORTANT BUT IT SHOWS
TEAM SCIENCE AND THAT IS ALSO
REALLY IMPORTANT THING BUT I
ALSO WANTED TO REITERATE TO YOU
THE IMPORTANCE OF BRINGING
PEOPLE TOGETHER AND IF THERE'S
SYMPOSIUM AND OTHER THINGS BUT
THE IMPORTANCE TO HAVE
MENTORING, YOU KNOW, EVEN
MENTORING WITH THEIR OWN PEERS
AND PEER MENTORING OF OTHERS AND
I THINK A LOT OF THE
ORGANIZATIONS DO THAT AND I
THINK THAT'S IMPORTANT FOR US TO
MAKE SURE THAT WE KEEP AN EYE
OUT ON WHO IS GETTING THESE
AWARDS AND ESPECIALLY IN THIS
MECHANISMS SO THAT WE CAN MENTOR
AND MAKE SURE THAT THERE'S
SUCCESS AND THEY DON'T GO OFF TO
INDUSTRY AND WE LOSE THEM SO
THANK YOU.
>> THOSE ARE GREAT POINTS AND
RECENTLY THE EARLY INVESTIGATORS
ADVANCEMENT PROGRAM THE EAIP WAS
ALSO FUNDED AND WE NOW HAVE A
CADRAY OF 20 PEOPLE AND EVERY
YEAR THERE'S ANOTHER 20, RIGHT
AND SO THE CULMINATION OF THE
GOAL TO CONNECT WITH MENTORING
BECAUSE WE UNDERSTAND THAT THE
EXPERTISE AND THE ABILITY TO AND
WITH THE EDUCATION PROGRAMS
WITHIN THE CANCER CENTER AND THE
PED THIS WILL BE REALLY
IMPORTANT AS WE LOOK AT
WORKFORCE IN OUR CANCER CENTERS
AND THE EDUCATIONAL PROGRAMS
THAT WE IMPLEMENT WITHIN OUR OWN
CANCER CENTERS AND INSTITUTIONS.
AS YOU CAN TELL FROM Dr. LOIS
COMMENTS WE HAVE THE SUPPORT OF
OUR LEADERSHIP AND THE
UNDERSTANDING IS I THINK THAT
MOVING FORWARD WE'RE IN A GREAT
PLACE.
LET'S TRY AGAIN.
>> STILL NO.
IT'S FRUSTRATING.
WE MIGHT HAVE TO RESORT TO A
CHAT COMMENT.
>> LEANNE THANK YOU FOR THE
PROGRAM AND I THINK IT'S
IMPORTANT AND I GUESS WHAT IS
GOING THROUGH MY MIND, WHEN I
THINK ABOUT SUCCESS, WE OFTEN
THINK ABOUT IT AS THE INDIVIDUAL
EFFORTS SO THE PERSON THAT
DIDN'T HAVE WHAT IT TAKES TO BE
SUCCESSFUL AND BUT TIME AND TIME
AGAIN MY EXPERIENCE SUGGESTS
THAT A LOT OF THESE
INSTITUTIONAL POINTS AND THERE
ARE SUPPORT THAT PEOPLE GET WITH
THE INSTITUTIONS AND INTERESTS
THAT EXIST, AND I KNOW IT MADE
THIS POINT BEFORE BUT IT WOULD
BE IMPORTANT IN THINGS THAT WE
CANNOT CONTROL AND A CONTROL IN
INSTITUTION BUZZ IT'S REALLY
IMPORTANT TO ADD THAT ON THE
RADAR IN TERMS OF HOW PEOPLE
REQUEST NAVIGATE IT TO GET
THROUGH THE PROCESS OF GOING
FROM ONE ARROW ON TO THE NEXT
AND SO I JUST WANT TO PUT THIS
ON THE RADAR.
I KNOW YOU KNOW THIS ALREADY BUT
I WANT TO RAISE IT AS WELL.
>> GREAT.
THANK YOU.
WE GOT THE COMMENT ON THE CHAT.
ANY FURTHER QUESTIONS?
WE CAN MOVE TO VOTING.
MOTION.
>> YEAH.
I MAKE A MOTION THAT WE PASS IT
AND AGAIN, I WANT TO THANK
LEANNE AND THE GROUP SHE WORKS
WITH FOR DOING THIS.
>> THAT'S A MOTION FOR APPROVAL.
>> SECOND.
>> AND ANY FURTHER DISCUSSION?
OK.
THE MOTION IS FORAY TRAVEL
LA FOR APPROVAL.ANY DISAPPROVALF
HANDS?
ANY ABSTENTIONS?
NONE.
PAULETTE.
>> OK IT'S UNANIMOUS.
>> VERY GOOD.
WE ARE UP TO OUR FINAL ITEM ON
THE BSA AGENDA WHICH IS THAT WE
NEED TO CONSIDER THE PAR REISSUE
CONCEPT AND WE'LL VOTE TO CON TO
CONQTO CONCUROR NOT CONCUR.
>> I'M GOING TO BE VERY BRIEF.
WHEN I SAY VERY BRIEF I MEAN
VERY BRIEF.
THERE ARE NINE REISSUE PARs
BUT THE BSA CONSIDERATION TODAY
AND THE LIST AND THE LINK WAS
SENT TO BOTH BOARDS PRIOR TO THE
MEETING.
AND IF YOU RECALL THIS IS NOW
NIH POLICY WHICH WAS ESTABLISHED
IN 2019.
AND ADDITIONAL, THE BSA
REQUESTED METRICS EVALUATING THE
P.A.R. AND IT INCLUDED METRICS
AS SUCH THE LIST PROVIDED BEFORE
TODAY'S MEETING ARE ALSO
INCLUDED LINKS TO EACH OF THE
CURRENT EPO As, IN THAT
REGARD, AND AS CHIEF JUSTICE OF
THE BAS WILL VOTE ON BLOCK TO
CONQUER WITH THE REISSUANCES.
I SHOULD NOTE THAT THE NAME OF
EACH P.A.R. REISSUANCE, WILL BE
LISTED IN THE MINUTES.
ARE THERE QUESTIONS?
>> IF THERE ARE NO QUESTIONS,
PLEASE CALL FOR THE VOTE.
>> WE WILL HAVE TIME FOR
DISCUSSION IN THE MIDST OF
VOTING AS WE ALWAYS DO IN TERMS
OF RULES OF ORDER AND I THINK I
GUESS I'LL ASK FOR A MOTION OR
PERHAPS I'LL START SINCE WE
HAVEN'T HAD DISCUSSION YET.
MY MOTION WOULD BE TO CONCUR TO
MAKE IT A SECOND ON THAT.
>> AS A CHAIR YOU SHOULD MAKE
THE MOTION OR SOMEONE ELSE MAKE
THE MOTION.
>> I WAS TRYING TO MOVE US
ALONG.
>> ANOTHER BAS MEMBER STEP
FORWARD.
>> SO MOVED.
>> MOVE TO CONCUR.
>> THANK YOU.
>> SECOND.
>>
>> GREAT OK I SEE THAT AND BOB,
GREAT.
SO NOW TIME FOR DISCUSSION.
HOWARD AND I HAD A SIDE BAR
GOING INTO TODAY'S CONVERSATION
SOHOARD YOU HAD A POINT OR TWO
TO RAISE.
>> YEAH, ABOUT THE P.A.R. THAT
IS DEALING WITH THE RENEWAL OF
RESEARCH AND CLINICAL --
>> YOU ARE BREAKING UP.
WE CAN'T HEAR YOU.
>> OK.
THE ONE THAT INCLUDES CLINICAL
TRIALS, IT IS -- I THINK QUITE
IF YOU DO THE MATH, IT'S A LOW
BUDGET PER GRANT AND IT'S LIKE
200,000 CAP PER YEAR FOR TWO
YEARS AND AS I HEAD IT IN TERMS
OF THE NUMBER OF GRANTS VERSUS
AGAINST THE NUMBER OF DOLLARS.
AND I JUST WANT TO INVITE NCI
VERY BRIEFLY HOW TO OPTIMIZE THE
COST EFFICIENCIES AND THE
LIKELIHOOD OF PERFORMANCE AND
ALSO THE LIKELY HID OF
SUBSEQUENT LARGER FUNDING AND
PARTNERSHIP WHICH IS SOMETHING
LIKE THIS IS REALLY HEADED
TOWARDS AN INDUSTRY PARTNERSHIP
TO BRING IT FORWARD TO THE MORE
COSTLY TRIALS AND I MEAN THIS
BUDGET MIGHT BE GOOD FOR UP TO
PHASE 1A BUT IT MIGHT BE OTHER
RESOURCES AND I DO HAVE A
QUESTION ABOUT OTHER RESOURCES,
AND THAT IS WHETHER THE
RECIPIENTS WILL BE ORIENTED
ABOUT OR ORIENTED ABOUT AND HAVE
ACCESS TO THE NO OR LOW COST
NCI.
SEEING THE MATURING AND THAT
HAVE IMMUNO ONCOLOGY BIOMARKERS
THAT ARE VALIDATED AND THINGS
LIKE THE PEDIATRIC TESTING
CONSORTIUM OR THE NCI TISSUE
REPOSITORY IN THESE UPDATING
DATA COMMONS.
WILL THESE RECIPIENTS HAVE THE
KIND OF ACCESS TO THESE THINGS
WHERE TECH GET THEM AT NO COST
IF THEY'RE PROPERLY ORIENTED HOW
TO INTEGRATE THEM AND --
>> HOWARD, I DON'T MEAN TO CUT
YOU OFF.
THIS PROGRAM ANNOUNCEMENT FOR A
SPECIFIC IN TERMS OF REFERRAL
AND REVIEW.
P.A.R.s DO NOT HAVE SET ASIDE
DOLLARS.
AS MUCH, WHEN THE APPLICATIONS
COME IN, THE LEADERSHIP WILL
ASCERTAIN OR MAKE A DECISION AS
TO WHAT THE LEDGER WILL BE SO
THE ISSUES ARE BRINGING UP NOW,
WOULD BE MORE GERMANE TO UO1s
OR MORE GERMANE TO LARGE
CLINICAL TRIALS THAT ARE
ESTABLISHED INITIALLY.
OK.
>> IF YOU WOULD LIKE TO DISCUSS
THIS OFF LINE, AT ANOTHER TIME,
PLEASE REACH OUT TO ME.
>> O. I JUST WANT TO OFFER THAT
THESE KINDS OF TOPICS I'M VERY
COMFORTABLE WITH AND I WORKED ON
THIS WITHIN INDUSTRY WITHIN
SMALL GRANTS AND.
>> I UNDERSTAND BUT PROGRAM
ANNOUNCEMENTS ARE NOT AT THAT
LEVEL.
>> OK.
>> I AM MISREADING WHAT WAS SAID
TO ME FOR REVIEW.
YOU DO THE MATH ON IT THE NUMBER
OF DOLLARS ALLOCATE TODAY THAT
P.A.R. ROW NEWELL AGAINST THE
NUMBER OF TARGET GRANTS --
>> I JUST INDICATED THAT THERE
ARE NO SET A SIDES PROGRAM
ANNOUNCEMENTS.
WE CAN DISCUSS THIS AT ANOTHER
TIME.
OK.
>>
>> ANY OTHER DISCUSSION ITEMS?
>> MOVE TO FINAL VOTING AND THE
MOTION IS FOR CONCURRENCE.
LOOKING FOR ANY VOTES OF NON
CONCURRENCE AMONGST PSA MEMBERS?
ANY ABSTENTIONS?
PAULETTE.
>> OK.
I A APOLOGIZE IF I WAS TOO
BRIEF.
>> THANK YOU SO MUCH.
JOHN, A POLL GOES FOR THE RATHER
DELAYED PASSING OF THE BATON BUT
IT IS YOURS THE REST OF THE WAY.
>> OK, KEITH.
THANK YOU.
SO THE BOARDS WILL NOW CONSIDER
ON GOING AND NEW BUSINESS AND WE
HAVE TWO NCAB SUBCOMMITTEE
MEETING ON MONDAY THE 13t
13th THAT INCLUDED THE
PLANNING AND BUDGET SUBCOMMITTEE
AS WELL AS THE AD HOC
SUBCOMMITTEE ON POPULATION
SCIENCES OF EPIDEMIOLOGY AND
DISPARITIES AND THE PLANNING AND
BUDGET SUBCOMMITTEE CHAIR IS
Dr. ANNA BARKER AND SHE WILL
GIVE THE REPORT.
>> THANK YOU, JOHN.
FIRST THANK YOU TO THE COMMITTEE
AND SUBCOMMITTEE HAD SOME GOOD
COMMENTS AND ALSO CERTAINLY TO
PAT WHO SUPPORTS OUR
SUBCOMMITTEE ALONG WITH MK WHO
DOES A GREAT JOB OF ACTUALLY
EXPLAIN WHAT IS IS EXTRAORDINARY
COMPLEX PROCESS, ESPECIALLY IN
2022 AND 2023 AND JUST A FEW
HIGHLIGHTS THAT THE REPORT IS
QUITE COMPLETE.
AGAIN, GREAT JOB ON THE REPORT
AND I WANT TO POINT OUT A FEW
THINGS.
2022 IS -- I HOPE IT WILL BE THE
CONTINUATION OF A TREND AND IF
YOU GO BACK TO 2020 IN TERMS OF
OUR PAYLINE, YOU WILL RECALL WE
STARTED WHEN A PAYLINE OF 8%
WHICH IS PRETTY AWFUL AND WE
COMMITTED, WE COMMITTED FUNDS TO
ACTUALLY RAISE THAT PAYLINE AND
WITH THE GOAL OF ACTUALLY
GETTING THE 15% BY 2025.
AND WE'VE ARRIVED AT 11% AND AT
SOME COST AND ACTUALLY AND THAT
IS ALWAYS IN THE OUT YEAR SO YOU
HAVE FOUR MORE YEARS AND ANOTHER
FIVE FOR '21, ET CETERA.
SOME THINGS HAVE HAPPENED AT OUR
HAPPENING THAT ARE LIKELY TO
IMPACT THAT AND TO TURNING TO
2022 WE GOT A BUDGET IN MARCH.
IT WAS -- WE GOT 5.4% INCREASE
AND NIH GOT A 7.6% INCREASE AND
IN THAT INCREASE, WE HAVE TO BE
A LITTLE CAUTIOUS ABOUT
INTERPRETING THE NUMBERS BECAUSE
IF YOU LOOK AT THE INCREASE IT
HAS FUNDS IN THERE FROM THE
MOONSHOT, 194 MILLION AND WE
HAVE $50 MILLION FOR THE
PEDIATRIC INITIATIVE AND SO OUR
BASE BUDGET ACTUALLY IS
SUBSTANTIALLY LESS THAN THE
$6.9 BILLION THAT YOU SEE AND
THE NEWS IS THAT NEXT YEAR IS
THE LAST YEAR FOR THE
APPROPRIATION FOR THE MOONSHOT.
AND WE HAVE A LOT OF
INFRASTRUCTURE SURROUNDING THAT
BUT AS DOUG POINTED OUT, THE NCI
HAS DONE THAT IN AN
EXTRAORDINARY FRUGAL WAY AND IN
TERMS OF NOT HAVING A LOT OF
ADDITIONAL FUNDS THAT ARE GOING
TO BE APPLIED DUE TO
ADMINISTRATION.
SO I COMMEND NCI FOR THAT.
WE'RE HOPEFUL THAT MOONSHOT 2.0
WILL COME BACK IN JUST A MINUTE,
WILL PICK UP THAT AND MAYBE ANNE
MORE FUND FORGERON THE NCI SO
2022, I THINK WE CAN COUNT IN
THE WIN COLUMN FOR US.
IF WE LOCK FORWARD TO 2023, THIS
IS PROBABLY ONE OF THE MOST
UNUSUAL YEARS IN TERMS OF
UNCERTAINTY THAT I'VE SEEN.
SO, WE HAVE ONE, WE HAVE A
BUDGET THAT WE WERE GIVEN IN
MARCH AND UNFORTUNATELY THE
PRESIDENT, AS M.K. AND PATRICK
BOW POINTED OUT THAT BUDGET WAS
CREATED BY THE PRESIDENT ALL THE
WAY LONG BEFORE THE OMNIBUS PASS
IN MARCH SO THE BUDGET THAT WE
HAVE ON THE TABLE IS FUELLY
SUBSTANTIALLY LESS THAN WE WOULD
LIKE BY $199 MILLION IN TERMS OF
A LOSS AND SO WE BELIEVE, AS HAS
HAPPENED SO OFTEN IN THE LAST
SINCE THE CLINTON ERA, CONGRESS
TENDS TO MOVE THESE BUDGETS UP,
ESPECIALLY AROUND THE NCI AND SO
WE'RE DEPENDING ON THAT
HAPPENING AND WE'RE NOT LOOKING
FORWARD TO ACTUALLY HAVING OUR
BUDGET CUTS SUBSTANTIALLY IN
2023.
SO I WANT TO TURN THOUGH TO A
COUPLE ISSUES THAT SHOULD BE ALL
ON EVERYONE'S PLATE AND
ESPECIALLY THOSE FOLKS IN THE
AUDIENCE TODAY WHO ARE THINKING
ABOUT OUR NCI BUDGET.
WE HAVE THIS ENORMOUS INCREASE
IN APPLICATIONS AND THAT IS NOT
GOING TO CHANGE.
BECAUSE THE THINGS THAT W JUST
ON BSA WE'VE NEVER HAD
MORE OPPORTUNITIES AND WE'VE
NEVER HAD MORE OPPORTUNITIES TO
BRING BETTER ADVANCE TO PATIENTS
AND THAT'S GOING TO CONTINUE
PLUS WE HAVE A MOONSHOT 2.0 AND
EVERY TIME WE HAVE AN INITIATIVE
LICK THIS, IT BRINGS THE NUMBER
OF APPLICATIONS UP BECAUSE
PEOPLE ASSUME THAT THEY'RE GOING
TO BE RESOURCES AND AT THE
MOMENT, WE DON'T KNOW HOW THE
RESOURCES FOR THE MOONSHOT 2.0
IS GOING TO BE APPROPRIATED ANDS
DOUG POINTED OUT TO THE
SUBCOMMITTEE, ALL OF THE VARIOUS
AGENCIES ARE INVOLVED IN
MOONSHOT 2.0 AND THAT IS GREAT
NEWS BECAUSE THEY BRING
DIFFERENT KINDS OF TALENT AND
CAPABILITY TO CANCER SO WE LOOK
FORWARD TO THAT AS WAS BY THE
WAY DONE IN MOONSHOT THE FIRST
MOONSHOT WHICH THE VICE
PRESIDENT UNDERTOOK.
AND SO, IT'S GOING TO BE REALLY
IMPORTANT, I THINK, THAT PEOPLE
UNDERSTAND THAT NCI IS THE PLACE
THE MOONSHOT SHOULD BE
HEADQUARTERS.
WHY THINK ANYONE BELIEVES IT
SHOULD BE ANYWHERE ELSE AND
LET'S HOPE THAT'S THE CASE.
SO, 2023, ALSO IS AN ISSUE FOR
US BECAUSE OF ARPA-H WHICH HAS
BEEN APPROVED AND IT IS IN THE
BUDGET FOR 20 2023 AT A LEVEL TT
IS LIKELY TO BE FUNDED BUT I
DON'T THINK THEY'RE GOING TO BE
ABLE TO SPEND THE MONEY SO WE
HAD SOME DISCUSSIONS IN THE
SUBCOMMITTEE ABOUT, AND I ASK MK
DURING HER PRESENTATION, YOU
KNOW, HOW DO WE ACCESS THOSE
FUNDS AND AS INSTITUTE OR
INDIVIDUAL AND WE DO KNOW YET.
AND BECAUSE WE DON'T HAVE A
DIRECTOR AND WE HAVE ONE
EMPLOYEE OF ARPA-H SO, THEN WE
HAVE AN OPEN AND NIH
DIRECTORSHIP AS WELL AND ALSO A
OPEN NCI DIRECTOR AND I'M
CONFIDENT THAT THE ADVOCACY
COMMUNITY WILL WEIGH IN ON THIS
IN ALL THE PLACES THAT MAKE A
DIFFERENCE.
I'M NOT GOING TO SAY MUCH MORE
ABOUT WHERE WE ARE WITH OUR
BUDGET BUT I WILL SAY THAT I
REALLY THINK THAT THE NCI WILL
BE, I THINK, SHOULD BE THE FOCUS
OF A LOT OF CONVERSATIONS ON
CAPITOL HILL IN THE NEXT FEW
MONTHS BECAUSE WE ARE THE AGENCY
THAT IS GETTING GRANTS AND WE
ARE THE AGENCY THAT IS ACTUALLY
PEOPLE WANT TO HAVE THEIR GRANTS
FUNDED FROM THE NCI AND FOR
CANCER AND I'M REALLY HOPEFUL
THAT PEOPLE WHO ARE ON-LINE
TODAY WILL TAKE THAT TO HART.
SO WITH THAT I WILL STOP THERE
THAT IS A COMPLETE RUN DOWN OF
THE NUMBERS YOU CAN REVIEW FOR
YOURSELF.
Mr. CHAIRMAN, THAT'S MY
REPORT.
>> THANK YOU, AND AS Dr.
BARKER MENTIONED, WE HAVE ACCESS
TO THE SLIDES THAT WERE
PRESENTED BY MK AND THE REPORT
WAS E-MAILED BY RICARDO SO IT
WAS ALSO E-MAILED THIS MORNING
SO JUST FOR INFORMATION
PURPOSES, SO PAULETTE, DO WE
NODE TO CALL A MOTION TO --
>> YES.
>> TO VOTE FOR APPROVAL OF THE
REPORT.
DO WE HAVE A MOTION.
>> YES.
>> YOU HAVE TO ACCEPT THE
REPORT.
>> RIGHT.
>> OK.
>> DO WE HAVE A MOTION TO ACCEPT
THE SUBCOMMITTEE REPORT?
>> SO MOVED.
>> SECOND.
>> IT'S BEEN MOVED AND SECOND.
WE NOW SHOULD VOTE AND CAN WE
SEE ANY NAYs?
ANY ABSTENTION?
IT'S UNANIMOUS.
>> OK.
>> SO NEXT WE HAVE Dr. PASKETT
WHO WILL PRESENT ON THE
POPULATION SCIENCE AND
EPIDEMIOLOGY AND DISPARITIES.
>> THANK YOU, VERY MUCH.
SO, THE FOCUS OF THE MEETING OF
THE SUBCOMMITTEE WAS TO BRIEF
EVERYBODY ON THE PROGRESS TO
DATE OF THE AD HOC WORKING GROUP
AND SO THE PRESENTATION WAS
SHARED BY THE THREE CO-CHAIRS
AND Dr. ELAINE A MARTINEZ AND
MYSELF AND Dr. MARTINEZ
REVIEWED THE CHARGE OF THE
WORKING GROUP AND IT WAS XIPHOID
AND EVALUATE THE CURRENT STATUS
OF BARRIERS TO PROGRESS ON
CANCER RESEARCH AND RACIAL AND
ETHNIC MINORITIES UNDERSERVED
POPULATIONS AND REALLY REMINDED
EVERYBODY THAT THE FOCUS IS ON
CANCER RESEARCH SO THE WORKING
GROUP TO DATE, WE HAVE OUR
MEMBERSHIP CONFIRMED IN APRIL OF
'21 AND WE STARTED MEETING IN
JULY AND WITH Dr. CASTLE AND
WE, THE FULL COMMITTEES ARE
MONTHLY ALSO AND SO OUR MEETINGS
HAVE ALSO INCLUDED SPEAKERS AND
FROM THE CENTER FOR RESEARCH
STRATEGIES AND DCCPS AND CRCHD
AND.
>> WE'VE GOT ALL THE DUCKS IN A
ROW NOW AND CENTER OF RESEARCH
STRATEGY HAS DONE ALL OF THE
RUNS ON THE ALL THE DIFFERENT
POPULATIONS AND NEXT MONTH THEY
HAVE RENPRESENT THE RESULTS TO E
DISCUSSED SOME EMERGING
RECOMMENDATIONS THAT ARE COMING
OUT AND MAINLY GAPS SO FOR
EXAMPLE, WE WERE NOT ABLE TO
CATEGORIZE THE RESEARCH ON ARA
AND OLDER RESULTS AND WE'RE
LIMITED FOR THE COLLECTION OF
LGBTQ PLUS RESEARCH AND SO THOSE
WILL BE IN OUR RECOMMENDATIONS
AND THAT WE NEED TO REFINE OUR
ABILITY TO DO THAT AND OUR GOAL
LAST THING IS THAT OUR GOAL IS
TO HAVE OUR REPORT TO PRESENT
AND TO THE SUBCOMMITTEE AND IN
DECEMBER THAT IS NOW OUR GOAL.
WE HAD A LIVELY DISCUSSION AND
IT'S CAPTURED IN THE MINUTES AND
AGAIN I JUST WANT TO THANK THE
CO-CHAIRS AND CRS IS REALLY
DOING A WONDERFUL JOB WORKING ON
ALL OF THIS FOR US.
SO, ANYWAY, I DON'T KNOW IF YOU
WANT TO ADD ANYTHING ELSE.
>> THANK YOU.
SO, WE WOULD LIKE TO SEE -- IS
THERE A MOTION TO ACCEPT THE
REPORT FROM THE SUBCOMMITTEE ON
POPULATION SCIENCE EPIDEMIOLOGY
AND DISPARITIES?
>> WE ACCEPT THE REPORT.
>> WE HAVE A MOTION.
SECOND.
IT'S BEEN PROPERLY MOVED AND
SECOND.
THE NCAB SHOULD VOTE.
DO WE HAVE ANY NAYs?
ANYONE WOULD LIKE TO ABSTAIN?
IF NOT, WE HAVE A UNANIMOUS VOTE
TO ACCEPT THE REPORT.
>> THANK YOU.
DO YOU THINK THE BOARD SHOULD
ADDRESS THAT ONE THING THAT CAME
UP WITH OUR DISCUSSION OF PAR
WAS THIS CONCEPT OF THIS
STRATEGIC PLAN AND SAYING THINGS
FIT INTO THE STRATEGIC PLAN OR
DON'T AND AT SOME POINT, THAT
MIGHT BE A REALLY NICE
PRESENTATION AND FOR US TO BE
ABLE TO SEE WHAT THE OVER ALL
LOOKS LIKE AND AS WE THINK ABOUT
HOW A P.A.R. AND RFA FITS IN
OVER ALL.
>> THAT'S A TREMENDOUS POINT AND
I THINK AND THE QUESTION BEMES
IS IT THE NCI'S STRATEGIC PLAN
OR IS IT THE DIRECTOR STRATEGIC
PLAN.
>> IT'S ON-LINE AND I SAID THERE
ARE.
>> WILL THE NEW DIRECTOR REVISIT
AND I DON'T KNOW, RIGHT BUT IT'S
A GREAT POINT AND I THINK IT'S
SOMETHING THAT WE SHOULD
DEFINITELY TALK ABOUT.
I SEE THREE ADDITIONAL HANDS.
>> ONE TOPIC I WOULD LIKE TO
DISCUSS IN THE FUTURE IS
SOMETHING WE TOUCHED ON VERY
BRIEFLY YESTERDAY, I DO THINK
WE'RE AT A CRISIS IN AK DEEMIA
WITH OUR TRAINEE AND THE MASS
RESIGNATION HAS HIT ACADEMIA AS
IT IS HITTING OTHER AREAS OF
BUSINESS AND AND IT MIGHT BE A
GOOD COMMITTEE REPORT TO WORK
ON.
>> SO CLARIFICATION, WHAT WAS
THE TIME YOU CAN HAVE.
>> THEY'RE NOT WANT TO GO GO
INTO THE SITUATION IS SUCH THAT
MANY TRAINEES DON'T EVEN GO INTO
POSTDOCS THEY'RE GOING STRAIGHT
FROM PH.D TO INDUSTRY AND OTHER
AREAS AND I THINK WE HAVE A REAL
PROBLEM.
>> THE IMPACT OF THE BUDGET.
>> YEAH.
>> ON CAREER ADVANCEMENT AND
CAREER.
>> IT'S JUST STAGGERING AND
PEOPLE WITH RESEARCH AND IN MY
SCOPE OF THE WORLD INFORMATICS
OR COMPUTATIONAL MEDICINE ARE
JUST PAID SOMETHING HAS TO BE
DONE THE WAY WE REIMBURSE PEOPLE
AND DEDICATED LEADERSHIP IN THE
CANCER COMMUNITY AND WITH A
UNBELIEVABLE BLEE NON
COMPETITIVE NIH SALARY GAP.
>> AGREED.
TOTALLY.
SO, DUALLY NOTED.
LET'S GO TO CHRIS.
>> SURE, THANK YOU, JOHN AND
THANK YOU, EVERYBODY FOR YOUR
LEADERSHIP AND IT'S GREAT TO SEE
YOU ALL.
VERY BRIEFLY, THE ELEPHANT IN
THE ROOM IS ARPA-H, I WOULD LIKE
TO MOVE THAT WE HAVE THAT ON OUR
AGENDA FOR THE DECEMBER JOINT
MEETING AND WE HAVE THE
APPROPRIATE REPRESENTATIVE FROM
ARHA-H PRESENT TO US AND IT'S
CRITICAL.
>> THANK YOU.
>> I BELIEVE IT WAS DOUG
MENTIONED THERE'S A DEPUTY
DIRECTOR WHO HAS BEEN NAMED AND
I THINK BETWEEN NOW AND THE NEXT
MEETING, THE NEXT JOINT MEETING
IN DECEMBER, MY ASSUMPTION IS
WE'LL HAVE THAT PERSON IN
PERHAPS A AND SO I AGREE IT'S A
GREAT TOPIC AND THEN ANNA --
>> SO FURS I WANT TO HELP BSA
FOR TAKE A REALLY IMPORTANT
TOPIC AND THAT'S THE MCED AND
THAT MEANS MCEDs ESSENTIALLY
MULTIPLE CANCER EARLY DETECTION
ASSAYS, I THINK THAT THIS IS A
SIGHS MICK SHIFT IN CANCER
RESEARCH AND WE'LL LOOK BACK ON
THIS AND KNOW THAT THIS IS A
SEISMIC SHIFT AND WE SAID THESE
THINGS WERE NEVER GOING TO WORK
BUT THEY ARE AND THEY'RE BEING
REIMBURSED BY INSURANCE
COMPANIES AND COMPANIES ARE
ACTUALLY OFFERING THEM WHITE
HOUSE IS LOOKING VERY CAREFULLY
AT IT FOR THE MOONSHOT 2.0 AND
SO IF WE START THINKING A LITTLE
DEEPER AND WE SPENT 50 YEARS AND
UNDERSTANDING, BEGINNING TO
UNDERSTAND THE GOUGH NOAM AND
OUR COVERAGE OF GENOME NOW IS
SUCH THAT CAN YOU DO THESE KINDS
OF THINGS AND SO THE SCIENCE
HERE IS COMPELLING AND IF YOU
LOOK AT THAT THE PUBLIC WILL SEE
AND YOU TAKE THE BRAILLE ASSAY,
THEY SAY AND I THINK THEY CAN
AND THAT THEY CAN DETECT CANCER
STAGE 1 AT 39% AND STAGE 2 IS
69% AND STAGE 3 IS 83% AND 92%
FOR STAGE 4 CANCER WHICH
SHOULDN'T SURPRISE ANY OF US BUT
THINK ABOUT THAT.
THEY DID THE REPERCUSSIONS OF
THIS AND I THINK THE NCAB
ESPECIALLY SHOULD HAVE A WORKING
GROUP ON THIS IN TERMS OF HOW DO
WE, IT'S A HUGE TOPIC AND ALL
THE WAY FROM, MIKE BROUGHT IT
UP.
THE PRO AN LIT TICKS ON THE
SAMPLES TO THE HOW DO YOU CANCEL
PATIENT CANCER INFORM WHAT ARE
WE GOING TO DO IF YOU TELL
SOMEONE THAT THEY HAVE A SIGNAL
FOR CANCER P. THAT IS WHAT WE'RE
SAYING WITH THE GALLERY ATTEST,
A SIGNAL.
WE DON'T KNOW WHAT THAT MEANS.
WE HAVE NO IDEA YET.
SO I REALLY THINK THIS IS SUCH
AN IMPORTANT TOPIC AND I HOPE
NCI CAN GET IN FRONT OF THIS AND
I REALLY COMMEND PHIL FOR
BRINGING THIS FORWARD AND THIS
TIME AND TAKING THIS UP BECAUSE
I THINK IT'S GOING TO BE A VERY
BIG DEAL IN THE FUTURE AND I
REALLY WANT US TO BE IN FRONT OF
IT.
TOTALLY AGREE.
OUR TOPIC FOR THE NEXT MEETING
IS THE CREATION OF A WORKING
GROUP AROUND THIS AREA AND NO
MICHAEL'S COMMENTS ABOUT ALL OF
THE DATA SCIENCE ISSUES AROUND
MOONSHOT TO ME IT'S ANOTHER ONE
AND I'M GOING TO GIVE MICHAEL
ONE MINUTE WE'RE REAL CLOSE TO
ADJOURNING.
IF YOU CAN KEEP IT SUCCINCT THAT
WOULD BE GREAT.
>> JUST YOU KNOW, I AM NOT A FAN
OF ARPA-H.
FUDGEDDED FEDERAL MANDATE
RESEARCH PROGRAMS AND BY THREE
AND THAT TO ME IS AN INDICATION
THAT NIH IS NOT DOING ITS JOB SO
WE'VE GOT TO DOUBLE DOWN ON OUR
EFFORTS TO LOOK ACROSS
INSTITUTES AND CENTERS IN THE
NIH AND GET JIGGY AND REAL AND
ABOUT INTER INSTITUTE
COLLABORATION AND NCI WILL BE A
LEADER IN THIS AND I WISH I
COULD CLAIM THREE PAPEL ABLE
SUCCESS THIS IS WHICH
INTERAGENCY APPROACHES AND HAVE
REALLY YIELD SUSTAINABLE, COMMON
INFRASTRUCTURE TO FUEL SCIENCE
IN THIS NEW DECADE.
IT'S A CONSIDERABLE CHALLENGE
AND A HUGE ELEPHANT IN THE ROOM
AND BY THE WAY, THESE ARE OUR
TAX DOLLARS AND WE CAN'T KEEP
ASKING FOR MORE AND WE HAVE TO
ESSENTIALLY BE MORE EFFICIENT
WITH WHAT WE HAVE AND I KNOW
THAT IS CURRENT TO THE WAY NCI
HAS APPROACHED THIS BUT AS A
TAXPAYERS AND A STEWARD OF WHAT
IS THERE, IT'S DIZZYING HOW
CONFUSING IT IS FOR RESEARCHERS
TO GET THE DATA AND TO GET THE
INFRASTRUCTURE, COMPUTE
INFRASTRUCTURE AND TO
ESSENTIALLY DEVELOP A.I.
STRATEGIES THAT ARE WINNING FOR
THEIR PATIENTS AND THEIR
PROGRAMS.
>> TOTALLY TOTE GROW.
IT WILL BE GREAT TO HEAR FROM
ARPA-H.
I THIS IT'S HERE AND I DON'T
KNOW WHAT CAN BE DONE AT THIS
POINT AND IT IS HERE AND YOU
KNOW, I THINK IT'S OUR ROLE AND
TO ENSURE THAT THE NCI HAS WHAT
IS NEEDS, RIGHT, TO ADVANCE
CANCER AND REDUCE MORTALITY
RATES.
WE'RE AT THE HOUR.
PAULETTE, I BELIEVE, WE SHOULD
MOVE TOWARDS ADJOURNING AND
PLEASE, PLEASE, THIS DOES NOT
MEAN THAT YOU ARE INPUT AND
QUESTIONS AND COMMENTS AREN'T
IMPORTANT.
YOU KNOW, I IMPLORE YOU TO
E-MAIL PAULETTE AND IF YOU HAVE
SOMETHING THAT YOU WOULD LIKE TO
ADD AND WE'LL MAKE SURE THAT IT
GETS ON THE AGENDA AND DON'T
JUST THINK THAT BECAUSE YOUR
NAME WASN'T CALLED THAT IT'S NOT
IMPORTANT AND WE'RE A MINUTE
OVER RIGHT NOW AND I DO FEEL THE
PRIVILEGE TO BE THE FIRST TO SAY
ALTHOUGH THE AUGUST-SEPTEMBER
MEETING WILL BE VIRTUAL THE
DECEMBER HAD BEEN HYBRID SO I'M
EXCITED ABOUT THAT TO HAVE THE
OPPORTUNITY TO GET IN ROOM AND
MEET AND SEE PEOPLE FACE-TO-FACE
AND I'M EXCITED ABOUT THAT AND
THERE BEING NO FURTHER BUSINESS,
PAULETTE, I WOULD LIKE TO
ADJOURN THE JOINT MEETING FOR.
>> IT'S YOUR PLEASURE TO DO TO.
>HAVE A GREAT SUMMER.