I'D LIKE TO WELCOME THE MEMBERS
OF THE NATIONAL CANCER ADVISORY
BOARD, OFFICIAL MEMBERS,
PRESIDENT'S CANCER PANEL
MEMBERS, STAFF, AND GUESTS.
MEMBERS OF THE PUBLIC WHO MAY
WISH TO EXPRESS THEIR VIEWS
REGARDING ANY ITEMS DISCUSSED
DURING THIS MEETING MAY DO SO BY
WRITING DR. PAULETTE GRAY, THE
EXECUTIVE SECRETARY OF THE BOARD
WITHIN TEN DAYS OF THE MEETING.
ANY WRITTEN STATEMENTS OR
QUESTIONS SUBMITTED BY MEMBERS
OF THE PUBLIC WILL RECEIVE
CAREFUL CONSIDERATION.
BOARD MEMBERS, I WANT TO REMIND
YOU THAT YOU MUST ABSENT
YOURSELVES VIRTUALLY WHEN YOUR
PARTICIPATION IN DELIBERATIONS
ON A PARTICULAR PRODUCT,
PROGRAM, OR OTHER SPECIFIC
MATTER WOULD CONSTITUTE CONFLICT
OF INTEREST OR CREATE APPEARANCE
OF ONE.
IT IS INCUMBENT UPON YOU TO
ADVISE THE EXECUTIVE SECRETARY,
DR. GRAY, AND ABSTAIN FROM ANY
PARTICIPATION, DISCUSSION, OR
ACTIONS REGARDING THOSE MATTERS.
IN LIGHT OF THE CURRENT POLICIES
GOVERN CONFLICT OF INTEREST
BASED ON FINANCIAL HOLDINGS OF
SPECIAL GOVERNMENT EMPLOYEES
INCLUDING ALL MEMBERS OF THE
BOARD WE MUST DEPEND ON YOU TO
VOLUNTARY ABSENT YOURSELF ON
MATTERS THAT COULD IMPACT THE
STATUS OF THOSE HOLDINGS.
WE TRUST YOUR JUDGMENT IN THESE
INSTANCES.
DURING ANY CLOSED SESSION, ANY
MATERIALS OR DISCUSSIONS OF
CONFIDENTIAL NATURE, DELIBERATED
ON TODAY, ARE PRIVILEGED
INFORMATION.
AND ARE MADE AVAILABLE TO YOU ON
A NEED-TO-KNOW BASIS, SUCH
DELIBERATIONS ARE PRIVATE AND
CONTENT SHOULD NOT BE DIVULGED.
SO, THE FUTURE MEETINGS, DATES
OF FUTURE MEETINGS WERE PROVIDED
TO ALL OF YOU AND ARE LISTED ON
THE AGENDA.
ALSO, WE NEED TO APPROVE THE
JUNE 14-15, 2022 JOINT BSA NCAB
VIRTUAL MEETING SUMMARY.
I'D LIKE TO CALL FOR A MOTION TO
APPROVE THE MEETING SUMMARY.
PLEASE UNMUTE IF YOU WOULD LIKE
TO MAKE A MOTION.
>> I MOVE.
>> SECOND?
>> SECOND.
>> PROPERLY MOVED AND SECONDED.
TO APPROVE THE MEETING MINUTES,
LET'S VOTE.
ARE THERE ANY NAYS?
ANY ABSTENTION?
PAULETTE, WE HAVE UNANIMOUS VOTE
TO APPROVE.
>> AGREED.
>> BY LAW, A QUORUM OF BOARD
MEMBERS IS REQUIRED FOR EACH
INSTANCE IN WHICH A VOTE MAY
OCCUR, WHETHER IN OPEN OR CLOSED
SESSION, DURING THIS MEETING A
MINIMUM OF TEN APPOINTED MEMBERS
MUST BE PRESENT TO VOICE THEIR
VOTES.
SINCE WE CAN'T PREDICT THE TIME
OR OCCURRENCE OF ANY MOTION,
YOUR PRESENCE IN THE VIRTUAL
ROOM FOR ALL SEGMENTS OF THE
MEETINGS IS A MUST.
PAULETTE, DO WE HAVE A QUORUM?
>> YES.
>> GREAT.
SO, ALSO, FOR EVERYONE
PARTICIPATING IN THE MEETING,
PLEASE, IN ORDER TO MAKE SURE WE
DON'T HAVE ANY INTERRUPTIONS
PLEASE MAKE SURE THAT YOU'RE
MUTED.
AND REMAIN SO UNTIL RECOGNIZED
BY EITHER MYSELF, PAULETTE,
DOUG, OR WHOEVER THE SPEAKER IS.
SO, WE CAN NOW OPEN TODAY'S
MEETINGS BASED ON OUR CURRENT
AGENDA, A REPORT FROM THE ACTING
NCI DIRECTOR, DR. DOUG LOWY.
DOUG?
>> JOHN, THANK YOU VERY MUCH.
I WOULD LIKE TO WELCOME EVERYONE
FROM THE NATIONAL CANCER
ADVISORY BOARD.
WE REALIZE THIS IS THE END OF
AUGUST, IT IS BEFORE LABOR DAY,
AND GREATLY APPRECIATE YOUR
ACTIVE PARTICIPATION TODAY.
IN ADDITION, FOR THOSE PEOPLE
WHO ARE NOT MEMBERS OF THE NCAB,
THANK YOU VERY MUCH FOR YOUR
INTEREST IN LISTENING ON THIS
IMPORTANT MEETING.
IF I COULD HAVE THE FIRST SLIDE
PLEASE.
I ENTITLED THIS PRESENTATION
ENDING CANCER AS WE KNOW IT FOR
ALL, WHICH REALLY TAKES AS ITS
TITLE WHAT PRESIDENT BIDEN HAS
SAID ON MORE THAN ONE OCCASION.
AND I'M GOING TO -- IF I COULD
HAVE THE SECOND SLIDE.
I'M GOING TO TALK ABOUT A NUMBER
OF DIFFERENT ISSUES, BUT
ULTIMATELY THEY REALLY ARE ABOUT
TRYING TO IMPROVE THE OUTLOOK
FOR PEOPLE WITH CANCER, AND TO
THE EXTENT POSSIBLE FOR CANCER
NOT TO HAPPEN AT ALL.
I'M GOING TO GO OVER SOME NCI
NEWS.
THEN TALK ABOUT SCIENTIFIC
UPDATES, CANCER MOONSHOT, AND
FREDERICK NATIONAL LAB PROGRAMS.
THESE WILL BE HIGH-LEVEL VIEWS
FOR EACH OF THESE AREAS, AND I
PLAN TO LEAVE ENOUGH TIME FOR
NCAB MEMBERS TO FEEL COMFORTABLE
IF THEY WANT TO ASK QUESTIONS
AND/OR MAKE COMMENTS.
LET'S GET TO SOME NCI NEWS,
WHICH MANY OF YOU ARE AWARE THAT
MONICA BERTINOLLI THIS MONTH WAS
NAMED BY THE WHITE HOUSE TO
BECOME THE NEW NCI DIRECTOR.
SHE'S AN OUTSTANDING
PHYSICIAN-SCIENTIST, SURGICAL
ONCOLOGIST, FROM HARVARD, WE DO
NOT KNOW EXACTLY WHEN SHE WILL
BE APPOINTED.
THE VETTING PROCESS TAKES A
CERTAIN AMOUNT OF TIME BUT WE'RE
LOOKING FORWARD TO HER ASSUMING
THE LEADERSHIP ROLE OF THE NCI,
AND AS MANY OF YOU ARE ALREADY
AWARE SHE WILL BE THE FIRST
WOMAN AS THE NCI DIRECTOR.
NEXT SLIDE PLEASE.
I WANTED TO HIGHLIGHT THAT WE
ARE GOING TO -- WE PLAN TO
PUBLISH IN A COUPLE OF WEEKS THE
ANNUAL PLAN AND THE BUDGET
PROPOSAL FOR FY 24, REFERRED TO
AS THE BYPASS BUDGET.
WE ARE ALWAYS A YEAR AHEAD WITH
PUBLISHING THE BUDGET.
LAST YEAR WAS THE FY23 BUDGET,
AND AS YOU WILL HEAR IN MORE
DETAIL FROM M.K. HOLOHAN, FY 23
IS A MERE FIVE WEEKS AWAY FROM
TODAY, WHEN IT WILL START.
FY 24 THEREFORE WON'T BE
STARTING FOR 13 MONTHS.
IN ADDITION TO THE BUDGET
PROPOSAL, WE'RE GOING TO, AS
WE'VE DONE IN THE PAST,
HIGHLIGHT SEVERAL SCIENTIFIC
OPPORTUNITIES.
THIS IS NOT INTENDED TO BE
COMPREHENSIVE.
INSTEAD, IT IS SIMPLY TRYING TO
TALK ABOUT AREAS WHERE WE SEE
IMPORTANT NEEDS AS WELL AS
OPPORTUNITIES.
THEN THE FOUR AREAS THAT WILL BE
HIGHLIGHTED THIS YEAR ARE
MULTI-CANCER DETECTION TESTS,
UNDRUGGABLE TARGETS, WHICH I
THINK REALLY ARE BECOMING
PROGRESSIVELY FEWER AND FEWER,
CELL THERAPY, AND PERSISTENT
POVERTY BECAUSE OF ITS EXTREME
ASSOCIATION WITH CANCER
DISPARITIES.
NEXT SLIDE PLEASE.
THIS IS THE ONE BUDGET SLIDE
THAT I HAVE.
M.K. HOLOHAN WILL GO INTO THINGS
IN MORE DETAIL.
I ACTUALLY SHOWED THIS SLIDE
BACK IN JUNE, AND IT WAS TO TRY
TO ESSENTIALLY SAY THAT WE THINK
THAT THE BUDGET FOR F.Y. 23,
ALTHOUGH IT HAS NOT YET BEEN
ENACTED, IF IT FOLLOWS OTHER
YEARS IT WILL BE SUBSTANTIALLY
HIGHER THAN THE PRESIDENT'S
BUDGET THAT WAS ANNOUNCED FOR
FY23, AND, AGAIN, YOU'LL HEAR
FROM M.K. HOLOHAN THAT THE HOUSE
IS $466 MILLION HIGHER AND THE
PARTIAL SENATE MARK IS $290
MILLION HIGHER.
WE DO NOT KNOW WHERE IT WILL
EVENTUALLY LAND OR WHEN THERE
WILL BE A FULL YEAR BUDGET.
NEXT SLIDE.
SO, GETTING TO SOME OF THE
SCIENCE, THIS PAPER THAT WAS
PUBLISHED FROM THE INTRAMURAL
PROGRAM, DIVISION OF CANCER
EPIDEMIOLOGY AND GENETICS, LOOKS
AT ALL CAUSE MORTALITY AND THE
ASSOCIATION WITH PHYSICAL
ACTIVITY.
AND THERE ARE REALLY TWO
IMPORTANT PARTS TO THIS AREA
THAT I WANTED TO HIGHLIGHT.
THE FIRST IS THAT IT IS AMONG
OLDER ADULTS 59 TO 82, AVERAGE
AGE WAS 70.
THEY WERE FOLLOWED FOR MORE THAN
TEN YEARS.
THE SECOND POINT, THEY LOOKED AT
DIFFERENT KINDS OF PHYSICAL
ACTIVITY, AND NOT SHOWN IN THIS
SLIDE BUT THE PAPER, THE
CITATION FOR THE PAPER IS SHOWN
ON THE BOTTOM, WATTS, ET AL.,
REALLY SHOWED THAT THE MORTALITY
RATES WERE RELATIVELY
INDEPENDENT OF TYPE OF PHYSICAL
ACTIVITY BUT INSTEAD REALLY
DEPENDED ON THE AMOUNT OF
PHYSICAL ACTIVITY, AS SHOWN IN
THE GRAPH.
WHAT THEY USE AS THE METRIC IS
WHAT'S CALLED NET OR METABOLIC
EQUIVALENT OF TASK.
IT'S A MORE PRECISE MEASURE THAN
JUST NUMBER OF MINUTES, BUT TO
TRANSLATE THAT, IF YOU'RE
WALKING AT 20 MINUTES PER MILE
OR 3 MILES PER HOUR THAT'S 3
METs.
IF YOU DO FIVE HOURS OF WALKING,
OF 3 MILES AN HOUR PER WEEK,
THAT MEETS THE GOAL OF 15 MET.
AND 7 1/2 IS HALF OF THAT.
THERE'S A SUBSTANTIAL DECREASE
IN MORTALITY RATE WHETHER IT'S
CANCER MORTALITY, ALL-CAUSE
MORTALITY, OR CARDIOVASCULAR
MORTALITY, BUT WHAT'S REALLY
IMPORTANT THE COMPARATOR,
BASICALLY THE PEOPLE THAT DIDN'T
EXERCISE.
SO, IT'S EXERCISING RATHER THAN
THE TYPE OF EXERCISE THAT'S MOST
IMPORTANT, AND IF PEOPLE DO MORE
THAN ONE TYPE OF EXERCISE THAT'S
GREAT.
BUT FINDING SOMETHING THAT YOU
FEEL COMFORTABLE DOING IS A WAY
OF LIVING LONGER.
NEXT SLIDE.
THIS IS IN THE AREA OF CANCER
TREATMENT WHERE THIS IS AN
EXTENSION OF KEYNOTE 355 TRIAL
PUBLISHED LAST MONTH, THIS IS AN
INTERNATIONAL TRIAL WHICH
BASICALLY SHOWS A SURVIVAL
BENEFIT AFTER APPROXIMATELY 3
1/2 YEARS OF THE TRIAL FOR WOMEN
WITH ADVANCED TRIPLE NEGATIVE
BREAST CANCER WHO HAVE HIGHER
LEVELS OF PD-1 USING A
COMBINATION OF STANDARD
CHEMOTHERAPY, PLUS
PEMBROLIZUMAB.
I THINK IT'S IMPORTANT THERE ARE
SO MANY WOMEN WHO HAVE
TRIPLE-NEGATIVE BREAST CANCER
AND WE DON'T HAVE AS MUCH TO
OFFER THEM AS WE HAVE FOR OTHER
KINDS OF BREAST CANCER.
NEXT SLIDE PLEASE.
THIS SLIDE REALLY HIGHLIGHTS A
TOBACCO CONTROL MONOGRAPH, WHICH
IS FOCUSED ON THE AREA OF
SMOKING CESSATION IN CANCER
PATIENTS.
AND THE EVIDENCE BECOMES
PROGRESSIVELY STRONGER THAT IF
PATIENTS ARE CURRENT SMOKERS AND
THEY DEVELOP CANCER, THEIR
OUTCOME, AS A GROUP, WILL BE
BETTER IF THEY STOP SMOKING.
AND THIS IS SOMETHING THAT
CLEARLY AT THE CANCER CENTERS WE
ARE STRIVING TO HAVE AS REALLY
STANDARD OF CARE AT ALL OF THE
NCI-DESIGNATED CANCER CENTERS.
BUT WE WANT TO MAKE SURE THAT
THIS PRACTICE GETS WIDELY
DISSEMINATED FOR THE MANY
PATIENTS WHO ARE TREATED OUTSIDE
OF THE MAJOR CANCER CENTERS, AND
I THINK THAT THE QUOTE HERE ON
THE BOTTOM RECTANGLE, IT'S NEVER
TOO LATE TO QUIT SMOKING, AND
THERE ARE CLEAR BENEFITS FOR
QUITTING SMOKING REGARDLESS OF
CANCER TYPE.
NEXT SLIDE.
AND THIS SLIDE IS REALLY
CONTINUING GOOD NEWS WHERE WE
OFTEN LOOK AT WHAT'S HAPPENING
WITH MORTALITY RATES WITH
MORTALITY RATES GOING DOWN, BUT
PART OF THE REASON THAT
MORTALITY RATES ARE GOING DOWN
IS THAT SURVIVAL RATES ARE GOING
UP AND THE NUMBER OF SURVIVORS
IN THE UNITED STATES REALLY
CONTINUES TO INCREASE.
WE NOW ARE SUBSTANTIALLY OVER 5%
OF THE TOTAL POPULATION OF THE
UNITED STATES ARE CANCER
SURVIVORS.
MORE THAN 2/3 OF THEM ARE OVER
65.
THIS IS SOMETHING REALLY TO BE
CELEBRATED BUT WE WANT MORTALITY
RATES TO GO DOWN FASTER AND FOR
THERE TO BE EVEN MORE SURVIVORS.
THANK YOU.
NEXT SLIDE.
I NOW COME TO THE AREA OF THE
CANCER MOONSHOT.
AND I TALKED ABOUT IT A BIT IN
JUNE.
I NOW WANT TO UPDATE YOU WITH A
SO-CALLED CANCER CABINET
MEETING, THE FIRST LADY, DR.
JILL BIDEN, PRESIDED AT THE
WHITE HOUSE.
THERE WERE MANY PEOPLE FROM
DIFFERENT AGENCIES, MANY MEMBERS
OF THE CABINET WHO PARTICIPATED.
AND WHAT YOU CAN SEE ON THE
RIGHT IS THAT THERE WERE A
NUMBER OF PRIORITY ACTIONS AT
THE CANCER CABINET, AND CLEARLY
WE CAN EMBRACE ALL OF THEM.
BUT I DO WANT TO HIGHLIGHT
NUMBER 4, WHICH IS BRINGING
CUTTING-EDGE RESEARCH THROUGH
THE PIPELINE TO PATIENTS AND
COMMUNITIES, BECAUSE AS I SAID
AT THAT MEETING, EVEN IF WE CUT
MORTALITY RATES BY 50% OR MORE,
IF WE AREN'T GOING TO CHANGE THE
OUTLOOK FOR PEOPLE WHO HAVE
CANCERS WHERE CURRENTLY THERE'S
NOT THAT MUCH THAT WE CAN DO TO
HELP THEM, WE WILL NOT BE ENDING
CANCER AS WE KNOW IT.
ON THE LEFT SIDE YOU CAN SEE THE
FACT SHEET WHERE IT SAYS
PRESIDENT BIDEN APPOINTS CANCER
PANEL MEMBERS.
AND THAT'S SHOWN ON THE NEXT
SLIDE.
THIS ONCE AGAIN, ELIZABETH
JAFFE, CAROL BROWN AND MITCHELL
BERGER HAVE BEEN NAMED VERY
ANALOGOUS TO MONICA BERTAGNOLLI
BUT NOT YET APPOINTED.
I WANT TO ACKNOWLEDGE, I'M SURE
THEY WILL DO A GREAT JOB BUT I
WANT TO ACKNOWLEDGE THE
INCREDIBLE JOB - NEXT SLIDE
PLEASE - THAT THE CURRENT
MEMBERS OF THE PRESIDENT'S
CANCER PANEL HAVE DONE, JOHN
WILLIAMS, EDITH MITCHELL, AND
ROBERT INGRAHAM.
AS YOU MAY REMEMBER FROM THE
PRESENTATION THAT JOHN WILLIAMS
MADE BACK IN JUNE, THEIR
MONOGRAPH WAS BRIDGING THE
CANCER SCREENING GAP, EXACTLY
NUMBER ONE PRIORITY ANNOUNCED AT
THE CANCER CABINET.
NEXT SLIDE.
THE MOONSHOT, THE NEXT PHASE,
YOU'VE ALREADY HEARD PREVIEWS OF
THIS WHEREAS WE DO WITH ALL OF
OUR RFAs, THE BOARD OF
SCIENTIFIC ADVISORS REVIEW THEM
BUT YOU WERE PRESENT AT THE
JOINT BOARD MEETING WHERE WE
DISCUSSED THE MOONSHOT SCHOLARS
PROGRAM, AND PREVIOUSLY
TELEHEALTH AND MULTI-CANCER
DETECTION.
AND THOSE THREE PROGRAMS ARE
GETTING OFF THE GROUND WHERE WE
ANTICIPATE THE FIRST SET OF
MOONSHOT SCHOLARS WILL BE NEXT
YEAR.
TELEHEALTH MADE THE FIRST AWARDS
ACTUALLY A FEW WEEKS AGO.
AND MULTI-CANCER DETECTION, AS
YOU HEARD IN JUNE, IT WAS
ROUNDLY ENDORSED AND GOING
FORWARD TO TRY TO DEVELOP THAT
IMPORTANT AREA.
NEXT SLIDE.
SO, THE NEXT THREE SLIDES REALLY
ARE TALKING ABOUT TRYING TO
OVERCOME HEALTH DISPARITIES, AND
ONE OF THE AREAS THAT NCI HAS
HAD A LONG-TERM COMMITMENT IS
WITH CLINICAL TRIAL ENROLLMENT
FOR NCI CLINICAL TRIALS.
DR. MCCASKILL-STEVENS AND HER
COLLEAGUES HAVE DONE AN AMAZING
JOB AS YOU SEE SUMMARIZED ON THE
RIGHT.
WHEN WE STARTED THIS EFFORT NOW
20 YEARS AGO, ABOUT 14% OF THE
ENROLLMENT WAS MINORITIES.
BUT IN THE MOST RECENT FULL
THREE-YEAR PERIOD BEFORE THE
PANDEMIC BEGAN, IT HAD INCREASED
TO 25%.
AND MOST OF THE INCREASE IS IN
AFRICAN AMERICAN AND HISPANIC
POPULATIONS.
ACTUALLY, ESPECIALLY HISPANIC
POPULATIONS.
AND THE DATA DURING THE PANDEMIC
HAVE NOT GONE DOWN IN TERMS OF
MINORITY ENROLLMENT, BUT WE
DON'T HAVE REALLY OFFICIAL DATA
YET FOR 20 AND 21.
NEXT SLIDE.
SO, ONE OF THE THINGS THAT I
TALKED ABOUT IN JUNE WAS THAT A
VERY IMPORTANT PART OF WHAT WE
SEE AS THE NEW PHASE OF THE
CANCER MOONSHOT IS TO INCREASE
ENROLLMENT OF UNDERREPRESENTED
GROUPS, TO NCI CLINICAL TRIALS.
AND PART OF THE GOAL IS TO MIMIC
THE AT-RISK POPULATION FOR THIS
SPECIFIC CANCER STUDY.
SO WE KNOW THAT THE RESULTS WILL
BE MORE REPRESENTATIVE.
SO, THIS IS TO HAVE MORE
UNDERREPRESENTED MINORITIES IN
TRIALS, BUT ALSO PATIENTS WITH
COMORBIDITIES, PATIENTS FROM
RURAL AREAS.
IN ORDER TO DO THIS, WE ARE
GOING TO NEED GREATER INVESTMENT
BECAUSE IT'S GOING TO BE
CRITICAL TO HAVE COMMUNITY
ENGAGEMENT.
AND WE NEED TO MODIFY THINGS IF
WE'RE GOING TO INCREASE
ENROLLMENT, NOT JUST AT THE
LEVEL OF THE PATIENT BUT ALSO AT
THE LEVEL OF THE HEALTH CARE
PROVIDER.
SO THAT THERE IS MORE DIVERSITY
AMONG HEALTH CARE PROVIDERS.
AND WE ARE IN THE PROCESS OF
TAKING STEPS TO TRY TO ENSURE
THAT THIS IS GOING TO BECOME
MORE OF A REALITY.
NEXT SLIDE.
THIS IS JUST AN ANNOUNCEMENT OR,
IF YOU WILL, LETTING EVERYONE
KNOW THAT IN NOVEMBER THERE'S
GOING TO BE AN NCI SUMMIT ON
INCREASING DIVERSITY, EQUITY,
INCLUSION IN EARLY-PHASE
CLINICAL TRIALS.
ABILITY THE GOAL WILL BE TO
IDENTIFY AND DISCUSS
IMPLEMENTATION, BEST PRACTICES
FOR INCREASING INCLUSION AND
EQUITY IN OUR CANCER CLINICAL
TRIALS.
AND THE NCI EQUITY INCLUSION
PROGRAM WILL BE HOSTING THIS AND
REGISTRATION INFORMATION WILL BE
AVAILABLE IN THE NEAR FUTURE.
NEXT SLIDE.
I'M NOW GOING TO TURN TO THE
LAST THREE SLIDES, WHICH IS
TALKING ABOUT FREDERICK.
WE'RE GOING TO HAVE A LARGER
DISCUSSION OF THE FREDERICK
NATIONAL LABORATORY WHEN WE HAVE
THE JOINT BOARD MEETING IN
DECEMBER.
BUT I WANTED TO TELL YOU ABOUT
THREE THINGS.
THE FIRST IS THAT MONKEYPOX HAS
OF COURSE BEEN IN THE NEWS VERY
HIGH PROFILE.
AND THERE ACTUALLY IS TREATMENT
AVAILABLE BUT HASN'T BEEN
SUBJECTED TO RIGOROUS EFFICACY
TRIAL IN PEOPLE.
SO THE FREDERICK NATIONAL
LABORATORY AND AUSPICE OF NIAID
HAS BEEN WORKING WITH THE
REPUBLIC OF THE CONGO CAN THE
OUTBREAK OF STRAIN 1, CAUSING
MORE THAN THE STRAIN 3 IN THE
UNITED STATES, THE EFFICACY
TRIAL HOPEFULLY WILL LEAD TO
DEMONSTRATION OF EFFICACY AND
ANTICIPATION IF STRAIN 1 WILL IS
DEMONSTRATED EFFICACY WILL ALSO
WILL BE FOR STRAIN 3.
NEXT SLIDE.
IN ADDITION, THE IMPORTANCE OF
TRAINING AND DIVERSITY AND
EQUITY DOESN'T JUST STAY IN
BETHESDA BUT ALSO EXTENDS TO THE
FREDERICK NATIONAL LABORATORY.
AND THERE ARE A NUMBER OF
ACADEMIC PARTNERSHIPS THAT HAVE
BEEN DEVELOPED IN RECENT YEARS
WITH ETHAN DEMOTROSKI LEADING
THE EFFORT WITH SEMINARS,
GRADUATE STUDENTS FROM
UNDERREPRESENTED GROUPS, AND
MORE PARTNERSHIPS UNDERWAY.
MY LAST SLIDE, WHICH IS THE NEXT
SLIDE, TALKS ABOUT A SURPRISING
VISIT THAT WE HAD A FEW WEEKS
AGO TO FREDERICK, WHERE WE HAD
SECRETARY BECERRA AND THE TWO
SENATORS FROM MARYLAND, BEN
CARDON AND CHRIS VALHOLEN AND
ONE OF THE CONGRESSMEN FROM
MARYLAND, DAVID TRONE, COME TO
THE FREDERICK NATIONAL
LABORATORY TO SEE IT, THEY HAVE
ALL BEEN WITH THE EXCEPTION OF
SECRETARY BECERRA, AND WE TALKED
ABOUT THE CAPABILITIES
ESPECIALLY IN AREAS OF CANCER
RESEARCH FOR THE FREDERICK
NATIONAL LABORATORY, AND MELINDA
HOLLINGSHEAD FROM NCI RUNS THE
MOUSE MODELS REPOSITORY,
PATIENT-DERIVED MODELS
REPOSITORY, GAVE THEM
DEMONSTRATION OF PATIENT DERIVED
XENOGRAFTS DEVELOPED FROM
PATIENT TUMORS AND EVERYONE WAS
VERY ENGAGED AND DR.
HOLLINGSHEAD DID A TERRIFIC JOB
IN EXPLAINING HOW WE DEVELOP
THESE.
WE NOW HAVE 600 MODELS WITH THE
GOAL OF GETTING TO 1,000, MADE
READILY AVAILABLE TO THE CANCER
RESEARCH COMMUNITY FOR PEOPLE
WHO WANT TO DO VARIOUS KINDS OF
TRANSLATIONAL RESEARCH
ESPECIALLY FOR DEVELOPING NEW
INTERVENTIONS.
THAT WAS AN UNEXPECTED
OPPORTUNITY TO TALK ABOUT THE
FREDERICK NATIONAL LABORATORY,
NATIONAL CANCER INSTITUTE, DR.
TABAK CAME UP FROM BETHESDA.
IT REALLY WAS AN IMPORTANT
OPPORTUNITY TO TELL THEM ABOUT
THE OPPORTUNITIES THAT WE SEE
FOR CANCER RESEARCH.
SO, I'LL STOP NOW AND THANK YOU
FOR YOUR ATTENTION.
AND LOOK FORWARD TO YOUR
QUESTIONS AND YOUR COMMENTS.
>> THANK YOU, DOUG.
WE NOW OPEN THE FLOOR FOR
QUESTIONS.
WE HAVE TIME FOR QUITE A FEW
QUESTIONS.
I WOULD, YOU KNOW, FROM A
STANDPOINT OF JUST CHAIR'S
PREROGATIVE WANT TO THANK YOU
FOR DISCUSSING THE PDX NET AND
ALL THE WORK IN DEVELOPING THE
MODELS.
I THINK, YOU KNOW, ONE REALLY
IMPORTANT POINT IS SOME OF THE
PROGRAMS THAT ARE IN PLAY TO
INCREASE DIVERSITY.
THE EXPANSION OF PBX NET TO
DERIVE 60% FROM MINORITY
PATIENTS TO UNDERSTAND THE
BROADER CONTEXT OF CANCER WITH A
MORE DIVERSE SET OF MODELS.
>> THANK YOU FOR POINTING THAT
OUT, JOHN, CLEARLY AN IMPORTANT
AND NEEDED INITIATIVE.
>> SO I KNOW WE'RE GOING TO HAVE
AN EXPANDED DISCUSSION ON NCI
FREDERICK AT THE JOINT BSA
MEETING YOU MENTIONED.
BUT IF YOU COULD, IS IT POSSIBLE
TO AT LEAST PROVIDE SOME CONTEXT
AROUND HOW THAT OPERATION WORKS
IN TERMS OF ITS FUNDING, ITS
RELATIONSHIP WITH NCI, AND I
KNOW THE RECOMPETING AND THINGS
OF THAT NATURE.
>> SO, THE FREDERICK NATIONAL
LABORATORY IS REALLY, IF YOU
WILL, A GOVERNMENT RESOURCE.
IT IS A CONTRACT LABORATORY.
AND ABOUT I WOULD SAY -- THE
AMOUNT OF MONEY THAT IS SPENT UP
THERE VARIES WITH THE YEARS, BUT
ABOUT TWO-THIRDS OF THE FUNDING
COMES FROM NCI, AND ONE-THIRD
FROM NIAID, WITH A NUMBER OF
DIFFERENT AGENCIES AND OTHER
PARTS OF NIH BENEFITING FROM IT.
IN TERMS OF THE ACTIVITIES, ONE
OF THE AREAS THAT WE ESSENTIALLY
TRANSITIONED TO WAS LOOKING AT
COVID IN A NUMBER OF DIFFERENT
WAYS DURING THE PANDEMIC, NCI
TOOK A LEAD ROLE IN SEROLOGY.
AND WE ACTUALLY ENDED UP
ESSENTIALLY BEING A TEST CENTER
FOR THE FDA, AND THEY USED OUR
RESULTS AS AN IMPORTANT
PARAMETER IN DECIDING WHETHER
EMERGENCY USE AUTHORIZATIONS
WERE GIVEN TO DIFFERENT
COMPANIES THAT WERE MAKING
VARIOUS DEVICES.
MOST OF WHAT WE DO IS CANCER
RESEARCH.
YOU HAVE HEARD ABOUT THE RAS
INITIATIVE, AND DINAH SINGER AND
OTHERS ARE INVOLVED IN LOOKING
AT BASICALLY HEARING FROM THE
COMMUNITY, FIRST WITH AN RFI,
AND THEN GOING OUT ACTUALLY IN
THE COMMUNITY AND ASKING PEOPLE
WHAT ARE SOME SIGNATURE
INITIATIVES THAT MIGHT BE
PURSUED AT FREDERICK.
FREDERICK AS A RESOURCE FOR
MODELS, PATIENT DERIVED
REPOSITORY, SPHEROID AND OTHER
MODELS, THE RAS INITIATIVE HAS
PATHWAY REAGENTS OF VARIOUS
TYPES.
THE FREDERICK NATIONAL
LABORATORY, WHEN WE STOOD UP THE
MATCH TRIAL, IT WAS IMPORTANT TO
HAVE MULTIPLE CENTERS FOR
SEQUENCING FOR DETERMINING IF
PATIENTS WOULD BE ELIGIBLE TO
JOIN THE MATCH TRIAL.
THAT WAS CENTERED AT FREDERICK.
AND THE OTHER CENTERS, THERE WAS
A LOT OF UPFRONT WORK THAT WENT
TO MAKE SURE THAT THERE WAS AT
LEAST 95% AGREEMENT BETWEEN THE
DIFFERENT GROUPS.
THE NEXT PROGRAM FOR EXAMPLE,
YOU KNOW, WHICH WE HAVE
PRESENTED IN THE RECENT PAST,
WHICH REALLY IS INVESTIGATOR --
IF YOU WILL, IT'S
INVESTIGATOR-INITIATED
TRANSLATION WHERE GROUPS THEN
APPLY TO TRY TO DEVELOP THEIR
TRANSLATIONAL IDEAS.
I THINK I'VE GONE ON ENOUGH.
>> THIS IS GREAT.
ARE THERE ANY OTHER QUESTIONS?
PLEASE USE THE RAISE YOUR HAND
TOOL.
>> YEAH, QUICKLY, DOUG, I KNOW A
LOT OF PEOPLE ARE ASKING
THEMSELF THE FOLLOWING QUESTION.
YOU KNOW, HOW THE PAYLINES LOOK
FOR 2023, WE KNOW 2022 IS PRETTY
MUCH IN THE BAG.
>> YEAH, AS SOON AS YOU TELL ME
WHAT OUR BUDGET IS FOR FY23, I
WILL GIVE YOU AN ANSWER.
>> I WAS JUST GIVING YOU A
CHANCE TO ANSWER THAT QUESTION
SO EVERYONE KNOWS WE DON'T HAVE
A BUDGET FOR 2023.
IF I COULD FOLLOW UP --
>> INSTEAD, LET ME --
>> THAT'S OKAY, JUST GIVING YOU
A CHANCE TO SAY THAT.
>> THIS IS A VERY, VERY HIGH
PRIORITY.
AS I HAVE TALKED WITH YOU
PREVIOUSLY, WE ARE PROGRESSIVELY
INCREASING THE INVESTMENT IN THE
RPG POOL, COMPARED TO ITS
PERCENTAGE OF THE OVERALL NCI
BUDGET, WHICH HAS LED TO AN
OVERALL INCREASE IN THE
PERCENTAGE OF THE NCI BUDGET
THAT IS IN THE RPG POOL.
AND WE LOOK FORWARD TO DOING
THAT.
>> YEAH A FOLLOW-UP, I WAS
ASKING BECAUSE I REALLY WANTED
TO ASK THIS QUESTION.
DO YOU SEE ANY REAL LEVELING OFF
OR EVEN ANY DECREASE IN THE
NUMBER OF GRANT APPLICATIONS,
ESPECIALLY R01s?
>> THE SHORT ANSWER, THE BIG
INCREASE THAT WE SAW A NUMBER OF
YEARS AGO SEEMS TO HAVE
PLATEAUED, YES.
>> THAT'S ONE OF THE REASONS
OBVIOUSLY FOR OUR SUCCESS RATE,
AND I THINK THAT'S NOT ALWAYS
UNDERSTOOD.
THANK YOU.
>> YEAH, AND, YOU KNOW, I THINK
THAT IF YOU LOOK AT THE METRIC
OF HOW MANY AWARDS ARE WE
GIVING, YOU KNOW, WE'RE GIVING
MORE AWARDS EVERY YEAR.
BUT THE -- YOU KNOW, WE HAVEN'T
BEEN ABLE TO KEEP PACE WITH THE
NUMBER OF APPLICATIONS, EVEN
WITH THEM BEING FLAT.
BUT, YOU KNOW, NED REALLY
DEVELOPED THE IDEA OF 15 BY 25.
WE NEEDED TO TAKE A PAUSE DURING
FY 22 BUT I'LL -- YOU KNOW, TELL
YOU THAT WE WENT FROM WE WENT
FROM 8 TO 11, YOU KNOW, IN A
VERY SHORT TIME PERIOD.
AND I'M HOPEFUL THAT WE WILL BE
ABLE TO RESUME GOING UP TOWARDS
15 BY 25.
BUT AS YOU UNDERSTAND, IT REALLY
IS DEPENDENT ON CONGRESS.
>> SO, DOUG, JUST TO AGUESS
DOVETAIL OFF THE CONVERSATION, I
THINK ONE OF THE ISSUES THAT'S
NEAR AND DEAR TO THE HEARTS OF
MANY OF OUR MEMBERS AND THE
COMMUNITY AS A WHOLE ARE ESIs.
AND SO, CAN YOU SPEAK TO, YOU
KNOW, WHERE WE ARE WITH THAT?
>> JOHN, WE CONTINUE TO GIVE
ESIs A 5 PERCENTILE BOOST,
OKAY?
WHENEVER WE TALK ABOUT THE
PAYLINE, IF IT'S 11 FOR
EXPERIENCED INVESTIGATORS, IT'S
16 FOR ESIs.
WE HAVE GIVEN MANY MORE AWARDS,
I DON'T WANT TO MAKE A MISTAKE
AND GIVE YOU THE QUANTITATION,
BUT WE'VE GIVEN MANY MORE AWARDS
TO ESI, LET'S SAY LAST YEAR,
THAN WE DID THREE OR FOUR YEARS
AGO.
ELECTRA, YOU HAVE A QUESTION?
>> HI, DOUG.
THANK YOU SO MUCH FOR YOUR
REPORT, ALL THAT YOU DO AND WILL
CONTINUE TO DO, I KNOW YOU WILL.
I JUST WANTED TO MAKE A POINT
AND ESPECIALLY FOR THE RECORD, I
APPRECIATE THE MOONSHOT
CONSIDERATION OF ENROLLING
UNDERREPRESENTED POPULATIONS,
THROUGH TRIALS, THAT WOULD
REPRESENT THE POPULATION WITH
THAT DISEASE.
I THINK THAT'S FABULOUS.
IT'S A HUMONGOUS START, A GREAT
CHANGE FROM WHERE WE ARE.
BUT I WOULD REALLY LIKE TO
REMIND PEOPLE THAT IF WE WANT TO
SAY THAT A TREATMENT, FOR
EXAMPLE, WILL WORK IN LET'S SAY
A SPECIFIC MINORITY POPULATION,
WHERE THE QUESTION IS RELEVANT
AND IMPORTANT FOR THAT MINORITY
POPULATION WE'RE GOING TO HAVE
TO RECRUIT PATIENTS TO THE
NUMBER THAT WE WILL HAVE
SUFFICIENT STATISTICAL POWER TO
ANSWER THAT QUESTION FOR THAT
RESEARCH GROUP.
SO, WE IN THE ALLIANCE FOR
CLINICAL TRIALS HAVE BEEN
LOOKING AT THIS.
AND WE ACTUALLY HAVE SEVERAL
TRIALS THROUGH THE NCTN
MECHANISM THAT ARE TAILORED TO
CERTAIN UNDERREPRESENTED
POPULATION GROUPS, AND ONE IS
OUR GET SET STUDY, FOR EXAMPLE,
WE SET A GOAL TO ENROLL 30%
MINORITY WOMEN, AND WE HAVE
CLOSED CELLS TO YOUNG WHITE
WOMEN BECAUSE WE HAVE FILLED
THOSE CELLS UP.
AND WE'RE NOW ONLY RECRUITING
BLACK WOMEN, YOUNG WOMEN, TO
THAT.
AND ONE MORE POINT I WANT TO
MAKE SO PEOPLE KNOW WE CAN DO
THIS, MONICA BERTAGNOLLI WAS THE
GROUP CHAIR AND GAVE US A
CHALLENGE 30% MINORITY
REPRESENTATION ON THE CLINICAL
TRIALS.
AS OF LAST MONTH IN ALLIANCE, WE
WERE ALMOST 24% FOR TREATMENT
TRIALS, AND ALMOST 44% FOR
CANCER CONTROL TRIALS.
SO, WE DID IT BY THE TOP SAYS
YOU'RE GOING TO DO IT.
SECOND OF ALL, YOU KNOW, WE
OPENED PROTOCOLS THAT
SPECIFICALLY ADDRESS OUR
MINORITY POPULATIONS AND THE
ISSUES THAT WERE RELEVANT TO
THEM, AND WHERE APPROPRIATE WE
MADE SURE IN PROTOCOLS THAT WE
SET OUR ACCRUAL TARGETS NOT JUST
TO BE REPRESENTATIVE OF THE
POPULATION WITH THE DISEASE BUT
FHIR SO WE COULD SAY IN THAT
POPULATION IF THE TREATMENT, IF
THE INTERVENTION ALSO WORKED.
AND I WOULD REALLY LIKE FOR THE
SCIENTIFIC COMMUNITY TO REALLY
VIEW THIS DIFFERENTLY AND REALLY
ASPIRE TO THESE GOALS BECAUSE
PERSONALLY I DON'T THINK WHERE
APPROPRIATE IT'S ADEQUATE ENOUGH
JUST TO RECRUIT TO THE
DISTRIBUTION OF THE DISEASE IN
THE POPULATION.
THANKS, DOUG, FOR LETTING ME SAY
THAT.
>> THANK YOU, ELECTRA.
ANNA, YOUR HAND IS UP.
IS THAT FROM PREVIOUS OR --
>> I'M SORRY, I'LL TAKE THAT
DOWN, YES.
>> ANYWAY, WE'RE GETTING CLOSE
TO THE 2:00 -- JOHN, FOR YOU,
11:00.
>> WE HAVE A COUPLE MINUTES IF
THERE ARE ANY OTHER BURNING
QUESTIONS.
>> YES.
>> YOU NEED TO UNMUTE, HOWARD.
>> DOUG, COULD YOU GIVE US A
COMMENT ON YOUR PREDICTED
DIRECTIONS AND HOW WE'RE SEEING
FRUIT COMING FROM THE OTHER --
FROM THE SIMX AND
IMMUNO-ONCOLOGY BIOMARKERS NOW
GETTING PUBLISHED AND VALIDATION
WORK GOING ON, DO YOU SEE HOW
THAT MIGHT BE COMING BACK TO
FURTHER ADVANCE THE GOALS THAT
ELECTRA ARTICULATED, NOT ONLY
JUST ACCRUAL BUT LET'S SAY GOOD
RESPONSES, NOT WASTING TIME OF
THE PATIENTS WHO DO ENROLL IN
THOSE STUDIES.
>> THEY HAVE REALLY BEEN
VALIDATING ASSAYS AND SHOWING
THAT THEY ARE RIGOROUS.
JIM DOROSHOW IS HERE, AND JIM
MIGHT WANT TO COMMENT FURTHER.
JIM?
>> THANKS, DOUG.
THANKS FOR THE QUESTION.
SO, I THINK THE THING THAT IS
PROBABLY MOST IMPORTANT IN THE
INTERMEDIATE TERM IS THAT
BECAUSE SIMAC ASSAY, IT'S A
GREAT PROGRAM, BUT IT'S BASED ON
OBTAINING SAMPLES FROM PATIENTS
ALREADY ACCRUED TO TRIALS.
WE ARE VERY FAR ALONG, AND IN A
SUBSEQUENT MEET WILL GO SHARE
THE NEW ACTIVITIES WE'RE
UNDERTAKING BUT ONE IS I-MATCH,
FOR THE FIRST TIME PATIENTS WILL
GET A STANDARDIZED SET OF
IMMUNOLOGICAL MARKERS BEFORE
THEY GO ON TRIAL, HIGHLY
VALIDATED, DONE IN CORE
LABORATORIES, TO DEVELOPING
BIOMARKERS.
IT'S DIVERSITY RESULT TO PREDICT
WHO WILL RESPOND AND WHO WILL
NOT.
THE ASSAYS ARE NOT STANDARDIZED
SO WE HOPE TO BE ABLE TO SET UP
A WAY IN WHICH WE CAN ACCRUE A
SUBSTANTIAL NUMBER OF PATIENTS
AND THEN GET FEEDBACK TO
UNDERSTAND BETTER AND BETTER
WAYS TO USE THAT INFORMATION TO
CHOOSE PATIENTS FOR IMMUNE
MODULATED TRIALS.
>> THANKS, JIM.
WE'RE AT TOP OF HOUR.
DOUG, THANKS FOR THE DIRECTOR'S
REPORT.
NEXT AGENDA ITEM IS REPORT FROM
M.K. HOLOHAN WHICH WILL BE THE
LEGISLATIVE REPORT.
M.K.?
>> THANK YOU, DR. CARPTEN.
THANK YOU FOR THE OPPORTUNITY TO
SPEAK WITH YOU ALL TODAY.
I WANT TO REMIND THE BOARD
MEMBERS AS I ALWAYS DO THERE'S A
DETAILED LEGISLATIVE UPDATE IN
YOUR MEETING MATERIALS.
THE TIME I HAVE TODAY I'M GOING
TO COVER SOME MAJOR TOPICS
BRIEFLY BUT THERE'S MORE DETAIL
IN THE UPDATE.
MY TEAM ARE GLAD TO TALK WITH
YOU OR STAFF SO REACH OUT WITH
QUESTIONS.
NEXT SLIDE PLEASE.
AS I THINK YOU'RE ALL AWARE THE
FISCAL YEAR ENDS IN LESS THAN A
MONTH.
WE'RE PREPARING FOR A CONTINUING
RESOLUTION, A C.R.
I WANT TO TELL YOU WE DO NOT
ANTICIPATE A GOVERNMENT
SHUTDOWN.
IT IS ALWAYS UNPOPULAR,
POLITICALLY RISKY, EVEN MORE SO
DURING AN ELECTION YEAR.
THAT DOESN'T MEAN THAT IT'S NOT
GOING TO BE LAST MINUTE BEFORE A
C.R. IS IN PLACE, THAT'S
BUSINESS AS USUAL FOR CONGRESS.
I WANTED TO SHOW YOU THIS
GRAPHIC, I'VE SHOWN IT BEFORE.
IF YOU'LL INDULGE ME IT
REPRESENTS THE BIG PICTURE OF
HOW NCI RECEIVES ITS FUNDING AS
PART OF THE FEDERAL BUDGET
PROCESS.
SO, AFTER THE PRESIDENT'S BUDGET
IS RELEASED, PROPOSAL FOR THE
FOLLOWING FISCAL YEAR, PRESIDENT
BIDEN RELEASED HIS FY23 PROPOSAL
IN LATE MARCH.
THEN CONGRESS HOLDS HEARINGS IN
STEP 2, BEGIN WORK ON PREPARING
SPENDING BILLS, AGENCY HEADS AND
DEPARTMENT HEADS TESTIFY.
THE NIH BUDGET HEARINGS WERE IN
MAY OF THIS YEAR.
THE RED X REPRESENTS WHERE WE
CURRENTLY ARE.
I SHOWED THIS IN JUNE.
WE WERE IN THE SAME SPOT THEN.
IDEALLY STEP 3 WHERE THE
APPROPRIATIONS COMMITTEES
CONFERENCE AND HAVE BIPARTISAN
NEGOTIATIONS, THEY FINALIZE
SPENDING BILLS, AND THEY ARE
ABLE TO BE READY TO BE ENACTED,
THAT HAPPENS IN THE SUMMER
IDEALLY AND WE CAN GET
APPROPRIATION BEFORE THE START
OF THE FISCAL YEAR.
IN REALITY, THIS ALMOST NEVER
HAPPENS.
IT'S HAPPENED IN THE PAST 26
YEARS, IT'S HAPPENED TWICE, FOR
NIH.
IN 1996 AND IN 2018.
IN 2018, IT HAPPENED BECAUSE OUR
FY 19 BILL WAS PAIRED WITH THE
DEFENSE BILL SO THAT REALLY
RECRUITED ALL THE MEMBERS WHO
WANTED TO VOTE FOR DEFENSE BUT
NOT LABOR H HAD NO CHOICE, THAT
SPARED US FROM BEING PART OF THE
LONGEST GOVERNMENT SHUTDOWN IN
HISTORY.
MANY PARTS OF THE FEDERAL
GOVERNMENT WERE SHUT DOWN FOR AN
EXTENDED PERIOD OF TIME AND WE
WERE VERY GRATEFUL TO HAVE
AVOIDED THAT.
SO WHAT YOU NEED TO UNDERSTAND
THERE'S VIRTUALLY NO CHANCE OF
APPROPRIATIONS BEING COMPLETED
BEFORE THE MIDTERM ELECTIONS IN
NOVEMBER.
PROBABLY WELL INTO DECEMBER,
HOPEFULLY NOT TOO MUCH LONGER
THAN THAT.
IT IS NOT LIKELY BUT NOT
IMPOSSIBLE APPROPRIATIONS COULD
BE PUNTED INTO THE NEXT
CONGRESS.
I THINK THIS IS UNLIKELY FOR A
FEW REASONS.
ONE IS THERE'S STRONG MOTIVATION
TO GET THIS DONE IN THIS
CONGRESS FOR THE RETIRING
MEMBERS, SEVERAL SENIOR
APPROPRIATORS RETIRING IN THE
SENATE, SENATOR ROY BLUNT
RANKING MEMBER, RICHARD SHELBY
FROM ALABAMA THE RANKING MEMBER
OF THE FULL COMMITTEE, AND
SENATOR PATRICK LEAHY, CHAIR OF
THE FULL COMMITTEE.
THEY WOULD LIKE TO GET THEIR
EARMARKS INTO THESE BILLS, GET
THEM DONE AND PUT THEIR MARK ON
THIS AS THEY HAVE BEEN DOING
THIS WORK FOR DECADES.
ON THIS NEXT SLIDE THESE ARE
SOME PHOTOS FROM OUR
APPROPRIATIONS HEARINGS IN MAY.
ON THE LEFT DR. LOWY TESTIFIED
REPRESENTING NCI AT THE MAY
HEARING IN THE HOUSE.
CHAIRMAN DELAURO WANTED TO MAKE
A POINT, THEY CONTINUED THE FY
22 OMNIBUS A FEW WEEKS BEFORE
THIS HEARING AND SHE WANTED TO
MAKE THE POINT THEY WERE ABLE TO
COME TOGETHER AND INCREASE THE
NCI BUDGET BY $353 MILLION,
WE'RE VERY FORTUNATE THESE
MEMBERS HAVE TAKEN A PERSONAL
INTEREST IN CANCER RESEARCH.
THEY HAVE COME TOGETHER EVEN IN
VERY PARTISAN TIMES TO SUPPORT
INCREASES FOR NIH AND NCI, A
GREAT BENEFIT TO US.
THE PICTURES ON THE RIGHT SHOW
ACTING NIH DIRECTOR DR. LARRY
TABAK AND NIAID DIRECTOR DR.
TONY FAUCI AT THE SENATE
HEARING.
THE COUNTERPARTS IN THE SENATE
CHAIRWOMAN PATTY MURRAY OF
WASHINGTON STATE AND SENATOR ROY
BLUNT RANKING MEMBER OF MISSOURI
AR COLLEGIAL AND HAD A SHARED
PLIGHTER.
I LIKE THIS PICTURE.
OVER THE TIME THEY HAVE GOTTEN
TO KNOW HIM PERSONALLY, KNEW DR.
SHARPLESS, WE'RE LOOKING FORWARD
TO INTRODUCING DR. BERTAGNOLLI.
IT'S GREAT TO HAVE DIRECT
COMMUNICATION.
WE'RE ABLE TO UNDERSTAND THEIR
CONCERNS AND BE RESPONSIVE TO
QUESTIONS THEY HAVE.
NEXT SLIDE PLEASE.
SO WHAT I WANT TO SHOW HERE,
BEFORE I START TALKING ABOUT THE
NUMBERS I WANT TO BE CLEAR ABOUT
WHAT THESE MEAN AND WHAT THEY
DON'T MEAN.
THESE NUMBERS THAT I'M GOING TO
SHOW YOU DO NOT REFLECT
BIPARTISAN NEGOTIATED SPENDING
PROPOSALS.
AND THAT'S NOT TO SAY THIS IS
NOT AN IMPORTANT START, AN
IMPORTANT PART OF THE PROGRESS,
BUT SERIOUS NEGOTIATIONS ABOUT
FY23 WON'T REALLY START UNTIL
AFTER THE MIDTERMS AND
LEADERSHIP ON BOTH SIDES OF THE
AISLE KNOW WHAT HANDS THEY ARE
PLAYING.
THE PARTIES HAVE ALSO NOT
ADDRESSED THE BIGGEST THRESHOLD
ISSUE THIS YEAR AND LAST YEAR,
FUNDING FOR DEFENSE VERSUS
NON-DEFENSE.
THIS IS A TOP LINE
DETERMINATION.
IT WAS A BIG OBSTACLE TO THE
PRESSES LAST YEAR.
WASN'T RESOLVED UNTIL FEBRUARY.
HOPEFULLY IT WON'T TAKE THAT
LONG THIS YEAR.
BUT I WILL SAY LAST YEAR WHEN IT
WAS RESOLVED THE OMNIBUS WAS
COMPLETED AND ENACTED WITHIN SIX
WEEKS.
SO ONCE THAT DOMINO FELL, THINGS
PROGRESSED QUICKLY.
ALSO LIKE LAST YEAR, THERE ARE
EVERGREEN POLICY DISPUTES ABOUT
IMMIGRATION, BORDER SECURITY,
IMMIGRATION, PLAYING OUT WHEN
THE SIDES BEGIN TO NEGOTIATE.
SO LOOKING AT THESE NUMBERS, THE
HOUSE HAD THE VOTES TO MOVE
THEIR BILLS OUT OF COMMITTEE.
THEY HAVE SLIGHTLY LARGER
MARGINS THAN THE SENATE.
SO THE APPROPRIATIONS COMMITTEES
WERE ABLE TO PASS THESE BILLS
OUT OF COMMITTEE, WHAT THEY
PROPOSED WAS A $466 MILLION
INCREASE FOR THE NCI.
WE WERE VERY GRATEFUL TO SEE
THAT.
THE SENATE, 50-50 SENATE DID NOT
HAVE THOSE VOTES SO CHAIRMAN
LEAHY, SAME SITUATION, POSTED
DRAFT BILLS, REFLECTING THE
MAJORITY VIEWPOINT IN THE
SENATE.
AND IT'S THE MAJORITY
PREROGATIVE TO DO THIS.
WHAT WE SAW WHEN THE SENATE BILL
WAS POSTED IN LATE JULY WAS
PROPOSED $290 MILLION INCREASE
FOR THE NCI.
SO, THESE NUMBERS ARE REALLY
IMPORTANT INDICATORS ABOUT WHERE
THE CONVERSATION IS GOING TO
START WHEN THEY BEGIN
NEGOTIATIONS.
NEXT SLIDE PLEASE.
SO I KNOW THERE'S A LOT OF
INTEREST IN ARPA-H, STILL EARLY
STAGES, THERE MAY BE MORE
QUESTIONS THAN ANSWERS.
BUT I THOUGHT IT WOULD BE
HELPFUL TO POINT THE BOARD TO
THE MOST RECENT PRESENTATION,
THIS IS THE MOST COMPREHENSIVE
INFORMATION THAT WE HAVE.
DR. TARA SCHWETZ PRESENTED AT
THE ADVISORY COMMITTEE TO THE
DIRECTOR IN JUNE.
AND INTERESTING PRESENTATION,
AND THE DISCUSSION WAS
ILLUMINATING I THINK.
I THOUGHT WE WOULD FOCUS ON WHAT
WE DO KNOW.
ARPA-H RECEIVED $1 BILLION
APPROPRIATION IN FY 22 OMNIBUS,
INCLUDED WAS AUTHORIZATION FOR
THE HHS SECRETARY TO TRANSFER
ARPA-H ANYWHERE WITHIN HHS, AND
SPECIFICALLY NOTED INCLUDING
NIH.
AND THAT IS WHAT HE DID.
HE DID THAT IN APRIL.
SO, I THINK PEOPLE ARE PROBABLY
PRETTY WELL AWARE THAT THERE IS
AUTHORIZING LEGISLATION THAT
REALLY REFLECTS SORT OF A
DISAGREEMENT WITHIN THE
SCIENTIFIC COMMUNITY, A LARGER
DEBATE WHERE SHOULD ARPA-H BE
AND INTERACT WITHIN NIH, IS IT
IMPORTANT IT'S OUTSIDE THE
STRUCK YOU -- STRUCTURE OF NIH
AGENCY OR CAN IT WORK
INDEPENDENTLY AND MAINTAIN THIS
WAY OF OPERATION.
I DON'T KNOW THE ANSWERS, I'M
NOT SURE IF THERE'S GOING TO BE
AUTHORIZING LEGISLATION.
THERE'S THREE BILLS.
ONE HAS PASSED THE HOUSE, ONE
INTRODUCED IN THE HOUSE, ONE
INTRODUCED IN THE SENATE.
THESE ARE PENDING.
THEY HAVE DIFFERENT APPROACHES.
THE ONE IN THE HOUSE THAT PASSED
THAT IS SPONSORED BY ANNA ESCHEW
OF CALIFORNIA WOULD PUT ARPA-H
IN HHS BUT NOT WITHIN NIH.
SENATE BILL INTRODUCED BY
SENATOR PATTY MURRAY AND RICHARD
BURR OF NORTH CAROLINA PREVENT
IT IN BEING LOCATE IN THE D.C.
AREA, IN THE NIH, PROHIBITED
FROM HIGHING ANYONE EMPLOYED BY
NIH IN THE PRIOR THREE YEARS.
WE DON'T KNOW WHAT'S GOING TO
HAPPEN OR WHO THE DIRECTOR WILL
BE.
THERE'S A LOT OF INTEREST IN
FIGURING OUT WHO WILL BE
APPOINTED TO LEAD THIS
ORGANIZATION.
IN MAY THERE WAS APPOINTMENT OF
DR. ADAM RUSSELL AS ACTING
DEPUTY DIRECTOR.
ONE OTHER THING I WANTED TO KNOW
ABOUT THE $1 BILLION
APPROPRIATION THAT ARPA-H
RECEIVED IN FY 22 THAT WAS GIVEN
TO THEM WITH THREE-YEAR BUDGET
AUTHORITY SO THEY CAN SPENT THAT
MONEY IN FY 22, 23, AND 24.
REALLY HELPFUL FLEXIBILITY FOR
THEM AS THEY ARE JUST GETTING
STARTED.
NEXT SLIDE PLEASE.
CAPITOL HILL IS A GHOST TOWN IN
AUGUST BUT NOT THIS YEAR.
ADMINISTRATION AND CONGRESSIONAL
DEMOCRATS HAD A GOOD AUGUST,
ADVANCING ALONG PARTY LINE
VOTES, THE FIRST CHIPS IN
SCIENCE ACT, YOU'VE HEARD OF
THIS WITH MANY NAMES.
IT STARTED TWO YEARS AGO BEING
CALLED THE ENDLESS FRONTIERS
ACT.
CHIPS IN SCIENCE ACT WILL INVEST
$52 BILLION IN U.S. PRODUCTION
OF SEMICONDUCTOR CHIPS AND
AUTHORIZED NOT APPROPRIATES A
FIVE-YEAR $81 BILLION INCREASE
IN FUNDING FOR THE NATIONAL
SCIENCE FOUNDATION.
INFLATION REDUCTION ACT ENACTED
AUGUST 16 IS REALLY ADVANCES IN
KEY DOMESTIC PRIORITIES FOR THE
ADMINISTRATION, HEALTH CARE,
ALLOWS MEDICARE TO NEGOTIATE
PRICES FOR SOME PRESCRIPTION
DRUGS, INVESTS IN CLIMATE CHANGE
AND CLEAN ENERGY, A REALLY
IMPORTANT PROVISION TO WORK TRUE
AND GET SENATOR MANCHIN'S
SUPPORT TO GET THROUGH THE
SENATE AND TAX OVERALL
PROVISION, TAXES FOR
CORPORATIONS, A BIG VICTORY.
THEY HAVE A LOT MORE WORK TO DO
THOUGH.
THERE ARE SOME MUST-PASS PIECES
OF LEGISLATION THAT HAVE TO BE
DEALT WITH IN THE NEXT MONTH.
THE USER FEES AUTHORIZATION FOR
FDA IS EXPIRING BY THE END OF
THE MONTH.
ALSO THE AUTHORIZATION FOR THE
SMALL BUSINESS INNOVATION
RESEARCH PROGRAM, AND NATIONAL
DEFENSE ANNUAL AUTHORIZATION.
SO WE EXPECT TO SEE ACTION ON
ALL OF THOSE BILLS IN THE NEXT
MONTH.
OTHER LEGISLATION WE'RE WATCHING
INCLUDES THERE WAS PANDEMIC
PREPAREDNESS LEGISLATION IN THE
SENATE, OBVIOUSLY ARPA-H
AUTHORIZATION, THERE WAS ALSO
COVID SUPPLEMENTAL BILL
INTRODUCED IN THE SENATE IN
JULY.
WE DON'T KNOW WHAT'S HAPPENING
WITH THAT OR WHAT MIGHT HAPPEN.
WE'VE SEEN REAL INTEREST IN THIS
CONGRESS, I'M SURE YOU'RE AWARE,
IN TELEHEALTH.
THERE'S BEEN OVER 50 BILLS
INTRODUCED, WE'RE WATCHING
SEVERAL OF THE BILLS, THE ONE
WITH THE MOST SPONSORS IS THE
CONNECT ACT.
THERE'S A LOT OF INTEREST IN
CONTINUING AND EXPANDING
TELEHEALTH FLEXIBILITY, SOME
THINGS THAT BECAME REALLY WELL
UNDERSTOOD DURING THE FIRST TWO
YEARS OF THE PANDEMIC.
ALSO CONGRESS HAS BEGUN TO PAY A
LOT OF ATTENTION TO CLINICAL
TRIALS, TO ACCESS AND INCLUSION,
NOT JUST FOR CANCER CLINICAL
TRIALS, FOR ALL CLINICAL TRIALS.
SO WE'RE TRACKING SOME
LEGISLATION IN THOSE AREAS AND
THAT DETAIL IS IN THE UPDATE
DOCUMENT.
NEXT SLIDE PLEASE.
SO THIS IS THE CONGRESSIONAL
CALENDAR.
ALWAYS SUBJECT TO CHANGE.
THEY RETURN, SOME RETURN, ON THE
6th OF NEXT WEEK WITH THREE
WEEKS TO PASS A CONTINUING
RESOLUTION TO AVOID GOVERNMENT
SHUTDOWN AND ADDRESS MUST-PASS
LEGISLATION THAT I REFERENCED
EARLIER.
THERE'S REALLY ONLY 11 DAYS
BETWEEN THEM COMING BACK AND THE
NOVEMBER MIDTERMS THAT BOTH
CHAMBERS ARE IN SESSION.
THE SENATE MAY BE BACK IN
OCTOBER FOR THESE TWO WEEKS THAT
ARE SLATED ON THE CALENDAR.
REALLY ALL MEMBERS OF THE HOUSE
WHO ARE UP FOR REELECTION AND A
THIRD OF THE SENATE, THAT'S UP
FOR REELECTION, WOULD LIKE TO BE
CAMPAIGNING IN THEIR DISTRICTS
AND STATES.
BUT THERE ARE 90 PENDING
NOMINATIONS FOR THE
ADMINISTRATION, NOT ALL ON THE
ARE GOING TO MOVE BUT THEY MAY
COME BACK TO WORK ON NOMINATIONS
IF IT'S SOMETHING THEY CAN'T GET
TO IN SEPTEMBER.
BECAUSE THERE MAY BE SOME THAT
THEY WANT TO GET DONE BEFORE
MIDTERMS.
AND WE'LL SEE WHAT HAPPENS WITH
THAT.
NEXT SLIDE PLEASE.
SO HISTORY TELLS US THAT THE
PRESIDENT'S PARTY LOSES SEATS IN
THE MIDTERMS.
THIS COVERAGE IS ON EVERY NEWS
REPORT ABOUT WHAT'S GOING TO
HAPPEN IN THE ELECTIONS.
I THOUGHT IT WAS INTERESTING TO
LOOK AT THESE DATA THAT SHOW
THERE'S ONLY BEEN TWO EXCEPTIONS
SINCE 1946 TO THAT HISTORICAL
LESSON.
FIRST WAS PRESIDENT CLINTON'S
SECOND TERM DEMOCRATS PICKED UP
FIVE SEATS AND PRESIDENT GEORGE
BUSH'S FIRST TERM WHERE
REPUBLICANS PICKED UP EIGHT
SEATS.
THAT WAS RIGHT AFTER 9/11, AND
SO THAT'S MAYBE LESS OF AN
OUTLIER THAN IT WOULD APPEAR
HERE.
NOT ONLY DO ELECTIONS MATTER BUT
ALSO MAJORITIES MATTER.
IT'S MUCH EASIER TO MOVE YOUR
PARTY'S AGENDA IF YOU HAVE A
HEALTHY MAJORITY AS OPPOSED TO
ONE OF THE SLIMMEST MAJORITIES
IN HISTORY THAT SPEAKER PELOSI
HAS BEEN DEALING WITH IN THE
HOUSE OVER THE PAST TWO YEARS,
FOR EXAMPLE, WHEN YOU CAN ONLY
LOSE A HANDFUL OF VOTES IT'S A
BIG CHALLENGE TO KEEP YOUR
CAUCUS TOGETHER AND BE ABLE TO
MOVE LEGISLATION.
SO WE'RE ALL INTERESTED I THINK
POLITICAL JUNKIES ARE INTERESTED
TO SEE WHAT HAPPENS.
IT APPEARS AS THOUGH THE
REPUBLICANS ARE STILL FAVORED
THROUGH MOST OF THE POLLING,
I'VE BEEN READING, TO RETAKE THE
HOUSE BUT PERHAPS WITH FAR
SMALLER MAJORITIES THAN EXPECTED
SO THE MAGNITUDE OF THE SHIFT IS
GOING TO BE IMPORTANT AS WELL AS
THE SHIFT ITSELF.
NEXT SLIDE PLEASE.
I WANTED TO SHOW YOU MY LAST
SLIDE, TURNOUT WILL BE REALLY
IMPORTANT IN THESE MIDTERMS,
MUCH HIGHER IN 2018, A LOT OF
PEOPLE -- MANY MORE SHOW UP FOR
PRESIDENTIAL ELECTIONS THAN
MIDTERMS SO IT'S INTERESTING TO
LOOK AT THIS AND SEE, WE SAW
THIS REALLY BIG INCREASE FROM
2014 TO 2018 AND WE'LL SEE HOW
GALVANIZING SUPREME COURT EVENTS
HAVE BEEN, I'M HAPPY TO TAKE
QUESTIONS NOW OR OFFLINE.
REACH OUT, I WOULD LOVE TO HEAR
FROM YOU.
THANKS.
>> THANKS, M.K.
THE FLOOR IS NOW OPEN FOR
QUESTIONS.
I'LL TAKE THE CHAIR'S
PREROGATIVE WHILE WE WAIT FOR
OTHER QUESTIONS.
AS WE THINK ABOUT THE MOONSHOT,
WILL IT SORT OF BUDGETARILY
OPERATE UNDER PREVIOUS
LEGISLATION OR REQUIRE NO
LEGISLATION TO FUND IT?
>> IT WOULD REQUIRE -- IT
WOULDN'T HAVE TO BE NEW
AUTHORIZATIONING LEGISLATION,
COULD BE APPROPRIATIONS BILL BUT
1.0 MOONSHOT WAS AUTHORIZED BY
THE 21ST CENTURY CURES.
>> RIGHT.
>> AND THEN APPROPRIATED.
>> RIGHT.
>> YEAH, IF IT WAS GOING TO BE
DONE IN THAT WAY, THROUGH --
THOSE WERE -- THEY CREATED
SET-ASIDES AND CREATED MANDATORY
FUNDING FOR THOSE PROGRAMS,
APPROPRIATORS CAN FUND NEW
PROJECTS AND INITIATIVES AND DO
FREQUENTLY.
BUT THAT WAS A DIFFERENT AND
SORT OF UNIQUE MODEL.
IT REALLY -- WE'LL SEE WHAT'S
PROPOSED FOR FY 24 BUT AS CAME
UP IN THE BUDGET SUBCOMMITTEE
HEARING, EARLIER IN DR. LOWY'S
PRESENTATION, I'M SORRY, THAT'S
A NEXT BUDGET YEAR LET'S SEE HOW
THEY HANDLING IT.
I CAN TELL YOU THERE'S AN
AWARENESS AMONG MEMBERS OF
APPROPRIATIONS STAFF AND
COMMITTEE MEMBERS THAT THIS END
OF THAT FUNDING IS COMING, AND
THAT THERE'S GOING TO HAVE TO BE
SOME CHOICES MADE AND WE WANT TO
CONTINUE THIS IMPORTANT WORK.
>> THANKS.
I SEE CHRIS' HAND.
>> M.K., THANKS, AS ALWAYS.
APPRECIATE YOUR TIME AND
THOUGHTFUL REPORT.
THIS IS PROBABLY MORE JUST TO
THE OF A STATEMENT AS OPPOSED TO
A QUESTION BUT MAYBE YOU HAD
CONVERSATION.
SEVERAL OF US ARE DEEPLY
CONCERNED THAT THE ADDITIONAL
COVID RELIEF PACKAGES HAVE
STALLED.
I THINK IT'S JUST IMPORTANT TO
BE ON THE RECORD TO SAY THAT,
YOU KNOW, SHOULD UNFORTUNATELY
THE COUNTRY HAVE MORE SURGES, WE
HAVE TO UNDERSTAND THAT A SURGE
OF COVID WILL HINDER OUR ABILITY
IN THE CANCER COMMUNITY TO
ENROLL PATIENTS TO TRIALS, TO
CONTINUE THE DISCOVERY WORK
THAT'S SO ESSENTIAL.
I HAVEN'T REALLY SEEN THAT
CONVERSATION AT THE NATIONAL
LEVEL.
I DON'T KNOW IF CONGRESS IS
AWARE OF THOSE CONNECTIONS, THAT
COVID MAKES CANCER CARE AND
CLINICAL TRIALS EXCEEDINGLY
DIFFICULT.
AND WE HAVE DOCUMENTED EXCESS
MORTALITY DURING THE COVID
PERIOD FOR PATIENTS WITH CANCER,
WHETHER THEY HAD COVID OR NOT
SIMPLY BECAUSE THEY CAN'T GET
CARE.
I GUESS THAT'S MY STATEMENT.
THE QUESTION FOR YOU IS, HAS
THAT CONNECTION BETWEEN COVID
RELIEF FUNDS AND ITS IMPACT ON
EITHER CANCER CARE DELIVERY OR
CLINICAL TRIAL ENTERPRISE, HAS
THAT BEEN A CONVERSATION THAT
YOU'VE HEARD ABOUT?
>> YOU KNOW, IT'S A REALLY
INTERESTING QUESTION.
I'M NOT SURE IT'S HAPPENED IN
QUITE THAT WAY.
WE HAVE RECEIVED SINCE THE
BEGINNING WHEN NCI RECEIVED A
$306 MILLION PIECE OF THE COVID
FUNDING AS PART OF AN NIH
PACKAGE, THERE'S BEEN INTEREST
IN HOW COVID AFFECTED THE QUICK
ADJUSTMENTS MADE TO CLINICAL
TRIALS, SO WE WERE ABLE TO
CONTINUE SOME REALLY IMPORTANT
PROGRAMS AND ACCESS FOR
PATIENTS.
NCI'S WORKED WITH SEROLOGY AND
EXCESS MORTALITY.
BUT I DON'T THINK IT'S BEEN
LOOKED AT IN SORT OF THAT
HOLISTIC WAY BECAUSE THAT MUST
ALSO BE TRUE FOR OTHER DISEASE
AREAS AS WELL.
AND, YOU KNOW, I THINK THAT'S
ACTUALLY A REALLY IMPORTANT
POINT.
AND I DON'T KNOW, I THINK WE'LL
SEE THE RUBBER WILL MEET THE
ROAD AFTER MIDTERMS IN TERMS OF
WHO IS WILLING TO GO TO BAT AND
SAY, LOOK, YOU MAY BE TIRED OF
TALKING ABOUT IT BUT COVID IS
NOT TIRED OF BEING HERE.
WE NEED TO ADDRESS IT AND BE
PREPARED.
AND PERHAPS SOME CONCERN ABOUT
MONKEYPOX WILL STIR THE FUNDING
BUT HELPFUL TO COME FROM PATIENT
GROUPS AND RESEARCHERS AS WELL.
>> GREAT COMMENT, CHRIS.
THANKS FOR THAT PERSPECTIVE,
M.K.
I THINK IT'S TIME TO MOVE ON TO
THE NEXT AGENDA ITEM WHICH WILL
BE A SCIENTIFIC PRESENTATION
FROM THE INTRAMURAL PROGRAM ON
HPV EPIDEMIOLOGY AND PREDICTING
COST EFFECTIVE CERVICAL
SCREENING FROM DR. SHIFFMAN,
DIVISION OF CANCER EPIDEMIOLOGY
AND CANCER GENETICS.
MARK?
>> HELLO.
>> PLEASE PUT UP MARK'S SLIDES.
>> I'VE BEEN ASKED TO TALK ABOUT
HOW EPIDEMIOLOGY IS PREDICTING
COST EFFECTIVE CERVICAL
SCREENING SOLUTIONS, JOINED BY
NICOLE CAMPOS FROM HARVARD TO
WORK ON THIS QUESTION.
WE HAVE NO CONFLICTS INTEREST.
TO AVOID CONFLICTS OF INTEREST
OVER MY CAREER WE PAY FOR
COMMERCIAL PRODUCTS, PUBLISH
INDEPENDENTLY.
THIS IS A PERSONAL PERSPECTIVE
I'D LIKE TO POINT OUT.
WE WANT TO SHOW HOW
EPIDEMIOLOGIC UNDERSTANDING OF
HPV AND CARCINOGENESIS CAN
GUIDE STRATEGIES.
OF ALL THE MAJOR CANCERS WE KNOW
MORE I THINK ABOUT CERVICAL
CANCER AND HPV THAN ANY OF THE
OTHERS.
WE HAVE A UNIQUE OPPORTUNITY TO
KNOW THE CAUSAL AGENT AND HOW TO
STOP IT.
AND THEN TO FIGURE OUT HOW TO
GET IT DONE.
MY FOCUS HAS BEEN ON
LOW-RESOURCE SETTINGS SINCE THE
START OF MY CAREER WHEN I LIVED
IN AFRICA AND WENT TO MED SCHOOL
AND THEN CAME TO NCI TO WORK ON
WHAT EVENTUALLY WAS A WHOLE
CAREER IN CERVICAL CANCER.
THIS SHORT PRESENTATION SHOWS
KEY PRINCIPLES OF WHAT WE'VE
LEARNED AND GIVES EXAMPLE OF
WHAT WE'VE COME UP WITH.
WITH THE MOONSHOT BEING THE MAIN
FUNDING, I'D LIKE TO POINT OUT,
SOME GREAT GRATITUDE AND OFFICE
OF AIDS RESEARCH AND INTRAMURAL
RESEARCH.
THE DISPARITIES IN CERVICAL
CANCER HAVE BEEN GREAT AND JUST
GETTING WORSE.
WE'RE DOING SO WELL BECAUSE OF
OUR NEW KNOWLEDGE OF HPV.
IN CERTAIN PLACES.
BUT FAILING TO REACH OTHER
PLACES SO THAT IT'S EXACERBATING
THE RELATIVE DISPARITY AND
BECOMING A DISEASE OF HEALTH
DISPARITY, BOTH NATIONALLY AND
INTERNATIONALLY.
PRACTICE LAGS BEHIND SCIENCE BY
DECADES IN CERTAIN PLACES.
IN CONTEXT OF W.H.O. CALL FOR
ACTION FOR ELIMINATION, WE HAVE
TO REALIZE THAT THERE'S A VERY
UNEVEN PATH TO ELIMINATION
DEPENDING WHERE YOU'RE AT.
THIS IS A REALLY NEW AND
FASCINATING GRAPH.
IT'S WORTH SPENDING A MINUTE ON.
IT'S IN MILLIONS OF PEOPLE.
IT'S SHOWING WHERE PEOPLE HAVE
NEVER BEEN SCREENED.
NOW, IF YOU IGNORE VACCINE AGES
AND JUST SAY SOMEBODY OVER 20
AND WHETHER THEY ARE IN A LOW
INCOME, LOWER MIDDLE, UPPER
MIDDLE, OR HIGH INCOME SETTING,
THE SCREENING KEY AGES WE'LL
TALK ABOUT IS BETWEEN 30 AND 49
OR 30 AND 45.
THOSE ARE THE BEST SCREENING
YEARS.
WHERE YOU CAN CATCH PRE-CANCER
AND PREVENT CANCER.
AND BECAUSE OF THAT, YOU WONDER
WHERE ARE THE MILLIONS OF PEOPLE
WHO ARE TOO OLD TO BE
VACCINATED, AND ARE GOING TO BE
AT RISK BECAUSE OF LACK OF ANY
SCREENING EVER, AND WHERE ARE
THE DEATHS GOING TO COME FROM?
YOU SEE IN TERMS OF SHEER
MILLIONS AND MILLIONS, MAINLY
THEY ARE IN LOWER, MIDDLE, SOME
OF THE UPPER MIDDLE, MEANING
THERE ARE SOME RESOURCES TO BE
HAD.
THE QUESTION IS, WILL THEY BE
ALLOCATED TO WHAT'S INCREASINGLY
EFFECTIVE VACCINE AND SCREENING
PROGRAMS.
MOST PEOPLE I THINK DON'T HAVE A
CLUE AS TO HOW COST
EFFECTIVENESS ANALYSES ARE
REALLY PERFORMED.
I DIDN'T.
AND I KNOW IT WAS COST VERSUS
BENEFIT BUT IT TURNS OUT THAT
THE FIRST THING AND ESSENTIAL
THING YOU DO IS TO DEVELOP A
NATURAL HISTORY MODEL.
YOU HAVE TO DETERMINE WHAT THE
HEALTH STATES ARE THAT LEAD TO
THAT CANCER OR OTHER DISEASE.
, DEFINE THE TRANSITIONS, DEVINE
VARIABLES AND MODIFY, ESTIMATE
TRANSITION RISK, CALIBRATE
ANYTHING YOU DON'T KNOW.
IF YOU DON'T KNOW A TRANSITION,
YOU NEED TO ESTIMATE IT.
YOU VALIDATE THE MODEL AGAINST
KNOWN DATA AND THEN YOU TAKE
WHATEVER YOUR PREVENTION
STRATEGY IS, ESTIMATE ITS
EFFICACY, APPLY TO A COHORT,
THERE'S MANY WAYS TO CALIBRATION
AND OFTEN UNCERTAIN KNOWLEDGE OF
A NATURAL HISTORY.
A LOT OF TIMES, PEOPLE CONSIDER
HEALTH DECISION ANALYSES TO BE
NOT AS IMPORTANT RESEARCH
FINDINGS AS DIRECT OBSERVATION.
WHAT WE'VE DONE IS WIDENING THE
SCOPE OVER THE YEARS IN THE NCI.
WE HAVE DONE INCREASINGLY
APPLICABLE THINGS ABOUT COST
EFFECTIVENESS.
FIRST WE STARTED WITH ETIOLOGY
AND PATHOGENESIS, WHEN WE DIDN'T
KNOW.
I STARTED IN 1975, IN THE FIELD,
AND I'VE BEEN WORKING 40 YEARS
FOR THE IRP, AND WE STARTED WITH
ODDS RATIOS LOOKING FOR THE
CAUSE AND SPENT THAT TIME
LOOKING FOR THE HPV TYPES THAT
WERE INVOLVED, THEN WE HAD
PREVENTION METHODS PERIOD, AND
NOW WE'RE VERY MUCH IN THE HEART
OF CLINICAL EPIDEMIOLOGY WHERE
WE'RE ESTIMATING RISK,
ARTIFICIAL INTELLIGENCE
GUIDELINES, PREVENTIVE
STRATEGIES, AND COST
EFFECTIVENESS.
BUT ALL OF THESE CONTINUE ON.
IT'S JUST WE'VE ADDED THE SCOPE
AS WE'VE GONE.
I WANTED TO SAY ONLY THAT THIS
IS ONE OF THE BEST UNDERSTOOD
NATURAL HISTORIES OF ANY MAJOR
CANCER.
AND IT LOOKS LIKE A CARTOON BUT
IT'S NOT.
IT'S ACTUALLY STOOD UP QUITE
WELL.
THE USUAL PATTERN IS HEALTHY
TISSUE, MINOR, SEVERE, DEATH.
FOR CERVIX 13 TYPES, THEY APPEAR
AND IF THEY DON'T GO AWAY WHICH
THEY USUALLY DO IT'S VERY
DYNAMIC AND COMMON, THERE'S A
PROGRESSION TO PRE-CANCER,
USUALLY SQUAMOUS, WHICH OVER
TIME CAN HAVE A GENETIC
MUTATION, INVADE AND CAUSE
DEATH.
THESE TERMS WHICH DON'T SEEM
LIKE SCIENTIFIC TERMS GIVEN WHAT
WE KNOW IS CIN OR OTHER TERMS
ARE BETTER TERMS BECAUSE THEY
ARE EXACT AND BASED ON MOLECULAR
AND OTHER EXACT MEASUREMENTS.
WE KNOW HPVs EXACTLY, WHERE IN
THE GENETICS AND PHYLOGENY
ONCOGENIC ARE, WE KNOW BY TYPE,
CAN MEASURE RELIABLY AND
ACCURATELY, AND PAY ATTENTION
ONLY TO THOSE THAT CAUSE
CERVICAL CANCER, WE KNOW THEIR
ORDER OF IMPORTANCE WHEN WE
STUDY TENS OF THOUSANDS OF
CERVICAL CANCERS.
SO WE KNOW TYPE 16 IS THE WORST.
1845 LESS.
NEXT THE 16 RELATED, AND OTHERS
CONSIDERED CARCINOGENIC BUT VERY
RARELY.
CANCER SERIES AND COHORTS SAY
THE SAME THING.
THERE'S NO COUNTER DATA.
WE KNOW EXACTLY WHICH TYPES AND
WHICH ONES ARE THE MOST
IMPORTANT.
ACCURACY IS REALLY IMPORTANT IN
CAUSAL CHANGE AND SO THAT LED
NATURALLY TO PREVENTIVE METHODS.
THOSE ARE MAINLY COHORT STUDIES
AND TRIALS WE DID IN THE '90s
AND 2000s, STILL ONGOING.
THE EPIDEMIOLOGISTS PIVOTED, AND
WE WERE WORKING WITH
IMMUNOLOGISTS, VIROLOGISTS, DNA
DIAGNOSTIC FOLKS, AND THROUGH
THOSE WE GOT VERY GOOD IDEAS OF
WHAT THE RELATIVE RISKS WERE AND
REDUCTIONS IN VACCINE EFFICACY
SO WE KNOW WHAT THE
INTERVENTIONS CAN DO, SCREENING,
AND VACCINE.
NOW WE'RE ON TO VACCINATION
BREAKING THAT FIRST EXPOSURE AND
WE HAVE ALSO SCREENING WHICH IS
FINDING PRE-CANCER BEFORE
CANCER, THE GOAL IS TO FIND
PRE-CANCER AND WE HELPED
VALIDATE MANY METHODS.
RIGHT NOW, WE'RE GOING TO
STRATEGIES BECAUSE BY 2005 WE
KNEW ALL THIS STUFF ABOVE.
AND IT'S STILL ALL THESE YEARS
LATER, WE'RE LOOKING TO HOW TO
GET IT TO THE PEOPLE WHO NEED IT
MOST.
THERE'S BEEN A STAGNATION OF THE
DECLINE IN THE UNITED STATES.
THERE'S A CONTINUED INCREASE IN
NUMBERS OF DEATHS, PLACES AROUND
THE WORLD, AGE THAT ARE HIGH
RISK.
WE'RE NOW TALKING VERY MUCH
ABOUT WHAT ARE THE WAYS TO MAKE
THESE INTERVENTIONS THAT ARE SO
ACCURATE SIMPLE ENOUGH AND COST
EFFECTIVE THAT THEY CAN COMPETE
FOR ATTENTION IN A WORLD THAT
HAS SO MANY DIFFERENT
PRIORITIES.
THE EMPHASIS IS ALWAYS ON
ABSOLUTE RISK.
SO, IF YOU THINK ABOUT THE
BEGINNING, WE JUST DIDN'T KNOW
PEOPLE GOT CERVICAL CANCER,
DIDN'T KNOW WHY.
AND WE'VE BEEN ABLE LIKE PLAYING
THE GAME OF TWENTY QUESTIONS TO
DERIVE QUESTIONS THAT ARE VERY
EXACT TO GET TO WHO IS AT RISK.
WE CAN DO IT QUITE WELL.
TAKE A SCREENING POPULATION.
AND THEN YOU JUST ASK PEOPLE,
ARE YOU HPV POSITIVE TODAY OR
NOT?
THAT'S ONE OF THE GOOD TESTS.
IF YOU'RE NEGATIVE, REASSURED.
INCREDIBLY PREDICTIVE.
IF YOU HAVE TWO NEGATIVES, VERY,
VERY REASSURING.
HPV POSITIVE YOU'RE ALERTED BUT
STILL DON'T KNOW WHO HAS
PRE-CANCER BECAUSE INFECTION IS
MUCH MORE COMMON AND OFTEN GOES
AWAY.
THEN IF YOU HAVE THAT, YOU NEED
A TRIAGE TEST, WHICH IF PERFECT
WOULD FIND ONLY THE PRE-CANCERS,
AMONG HPV POSITIVES, TURNS OUT
USUALLY YOU CAN HAVE THE NUMBER
AND GET CLOSER TO KNOWING
EXACTLY THAT THE PEOPLE YOU NEED
TO BE TREATING ARE WITHIN THAT
GROUP AND YOU DON'T WANT TO MISS
THEM BECAUSE THEY MOTIVATE THE
ENTIRE EXERCISE.
ACCURACY EQUALS EFFICACY.
OLDER TECHNOLOGIES NEED
REPETITION TO OVERCOME ERROR.
BUT HIGHLY ACCURATE TEST
PERFORMED LESS OFTEN IS
PREFERABLE.
WE DON'T WANT TO DO ACCURATE
TESTS TOO OFTEN, THE PRINCIPLE
IS TRUE IN HIGHER RESOURCE
SETTINGS, IN LOWER FOR
AFFORDABILITY AND
SUSTAINABILITY.
YOU ONLY NEED A COUPLE REALLY
GOOD SCREENINGS IN A LIFETIME TO
GREATLY REDUCE RISK.
AND THE OLD TERMS SO WHAT I DID
IN MED SCHOOL ARE ANTIQUATED,
STILL USED ALL THE TIME, USEFUL
AS A WAY OF COMMUNICATING BUT
PROXIES FOR THE REAL MOLECULAR
PROCESSES WE UNDERSTAND AT THE
HEART OF THE CARCINOGENESIS.
SIMILARLY ANYBODY WHO THINKS
THAT YOU CAN LOOK AT A CERVIX
AND TELL WHAT IT IS, IT'S HARD
TO KNOW THE DIFFERENCE BETWEEN
INFECTION, WHICH IS HERE, AND
PRE-CANCER.
SO, WHAT WE'VE DONE IN THE
MOONSHOT IS TO TRY TO ACCELERATE
THE TAKING UP OF HPV-BASED
THERAPIES, AND BASICALLY
THERAPIES PREVENTIVE THERAPIES,
LIKE PAVE, HUMAN PAPILLOMAVIRUS
AND AUTOMATED VISUAL EVALUATION.
I'M GOING TO USE THIS AS JUST AN
EXAMPLE.
THIS IS WHO WE ARE, RIGHT NOW,
THERE'S LOTS OF US.
THIS IS MOONSHOT-SUPPORTED
INITIATIVE, PEOPLE VOLUNTEERED
AND THEY GOES AWAY.
BASICALLY WE'RE DOING IT IN THE
UNITED STATES AND WE HAVE A
MISSISSIPPI GROUP THAT MEGAN
CLARK IS RUNNING AND ALL THESE
DIFFERENT COUNTRIES.
AFTER A PANDEMIC DELAY WE'RE UP
TO GETTING READY TO START THE
SCREENING, A VALIDATION OF THIS
COST EFFECTIVE DESIGNED
STRATEGY.
SO WHAT WE WANT TO DO IS THE
RIGHT THING FOR THE GREATEST
NUMBER OF WOMEN.
AND HOW DO WE DO THAT?
WE DO IT THROUGH ACCURACY,
PUTTING THEM ON THEIR RIGHT
PLACE IN THE CAUSAL DIAGRAM.
IN OTHER WORDS, AS YOU GET
INCREASING RISK TOWARDS CERVICAL
CANCER, YOU DO MORE FOR PEOPLE.
AND IT'S EQUAL MANAGEMENT OF
EQUAL RISK.
THE FIRST THING YOU DO IS GO
WHERE THERE'S A DISEASE.
IF YOU'RE A PLACE LIKE BRAZIL,
YOU KNOW WHERE THERE'S BEEN
CANCER IN THE LAST FIVE YEARS.
GO TO THOSE PLACES.
DON'T GO TO PEOPLE SCREENED A
LOT.
GO WHERE THEY HAVEN'T BEEN.
IF YOU CAN DO THAT, YOU CAN THEN
FIND WHO IS AT RISK.
THROUGH A SELF-SWAB TECHNIQUE
YOU CAN SELF-SAMPLE SOMEBODY,
THEY SELF-SAMPLE THEMSELVES, THE
IMPORTANT POINT, THEY
SELF-SAMPLE.
WOMEN HELPING WOMEN.
AND BASICALLY THAT SELF-SAMPLE
IS ANALOGOUS, ALMOST THE SAME
SENSITIVITY OF A CLINICIAN
SAMPLE.
IT'S THEN PUT INTO A HIGH-RISK
HPV TEST WHICH WE WORKED HARD TO
GET TO THE $5 RANGE AND IT
REASSURES EVERYONE NEGATIVE AND
THEY GO HOME.
IF POSITIVE, THEY NEED TRIAGE.
YOU PUT THEM IN TYPE GROUPS TO
DICTATE RISK, ADD TO THEIR
APPEARANCE.
APPEARANCES ARE VERY HARD FOR
HUMANS TO TELL APART.
FORTUNATELY, THEY CAN WITH SOME
RELIABILITY AT THE EXTREMES BE
PUT INTO VERY SUSPICIOUS, INTO
BAD OR GOOD OR DON'T KNOW, BY
MACHINE LEARNING, DEEP LEARNING.
THAT'S CALLED AUTOMATED VISUAL
EVALUATION WHICH WE'VE BEEN
WORKING ON FOR SEVERAL YEARS
NOW.
THE COMBINATION OF COMMENT
ELEMENT -- COMPLEMENTARY
BIOMARKERS DO THE BEST JOB,
AGAINST HISTOPATHOLOGY AND
VIROLOGY CAN KNOW WHO NEEDS TO
BE TREATED USING NEW TOOLS,
THERMAL ABLATION, 20 TO 40
SECONDS, OR IF NEEDED EXCISIONAL
TREATMENT OR REFERRAL.
I'M NOT SAYING THIS IS THE WAY
TO GO.
THIS IS PRE-PANDEMIC.
YOU CAN SCREEN HUNDREDS OF
PEOPLE IN A CLINIC ROOM PER DAY.
AND IT'S JUST BECAUSE IT'S
SELF-SAMPLED.
AND THERE'S MANY DIFFERENT
APPLICATIONS OF IT.
NOW, I WANT TO SAY A WORD ABOUT
ARTIFICIAL INTELLIGENCE AS THE
NEXT PART BEFORE I END.
THIS IS A TREMENDOUS IMAGE
RECOGNITION APPROACH FOR
CLINICIANS BECAUSE YOU GOT TO
LOOK AT THE CERVIX TO TREAT, WHY
NOT TAKE A PICTURE AND HAVE IT
ANALYZED.
DON'T BE TAKEN IF IN IT LOOKS
GOOD TO TO BE TRUE.
BE SKEPTICAL OF CLAIMS,
PERFORMANCE DECLINES FROM THE
TRAINING SETTING AND WE'VE
GOTTEN BACK TO GOOD A.I. IMAGE
RECOGNITION FOR PRE-CANCER.
DEEP LEARNING IS NOT MAGIC, JUST
WHAT YOU LABEL THINGS.
HOW WE'RE DOING IT, WE COMBINE
USING DEVICES EITHER DEDICATED
OR NOT, WE HAVE MANY DIFFERENT
ALGORITHMS.
AND WE PUT TOGETHER THE RISK
ESTIMATES FROM THE HPV
16 IS THE WORST, THAT VARIABLE
IS CROSSED AGAINST APPEARANCE
VARIABLE, YOU GET A RISK
STRATIFICATION SCORE WHICH CAN
BE USED BY THE LOCAL NLH OR
WHATEVER TO DECIDES WHO THEY
WILL TREAT, WITH ABLATION,
REFERRED, SUSPECT CANCER.
SOUNDS COMPLICATED BUT IT REALLY
IS AN APP THAT TAKES THE BEST OF
OUR KNOWLEDGE AND PRESENTS EASY
CHOICES.
AND IT JUST BASICALLY WORKS LIKE
THIS KIND OF A CURVE, WHERE YOU
TAKE THE WORST AND DEFINITELY
TREAT THEM AND FIND FOR YOUR OWN
SETTING HOW YOU'RE GOING TO
TREAT AND YOU PUT THAT INTO THE
APP.
AND THAT'S A LOCAL USE.
SO, WHEN WE TALK ABOUT HOW DOES
THIS ALL AFFECT HEALTH DECISION
ANALYSIS, BASED ON ALL OF OUR
IMPROVED TRANSITION
PROBABILITIES, WE ARE NO LONGER
CALIBRATING MUCH.
WE'VE OBSERVED THINGS FOR 20
YEARS.
SO 20-YEAR COHORTS OVER THE LIFE
COURSE GIVES US VERY GOOD
TRANSITION RISKS.
WHICH MEANS IT'S HIGHLY RELIABLE
AND CAN DO COUNTER-FACTUALS OF
PREDICTING WHAT WOULD BE OF THIS
OR THAT WITH A FAIR DEGREE OF
CONFIDENCE THAT IT'S TRUE.
AND SO, AS OPPOSED TO GUESS
WORK, IT BECOMES A VERY USEFUL
ALMOST ACCOUNTING TOOL AS WE
PLAN HEALTH DECISIONS.
BY DIRECT MEASUREMENT OF THESE
WE NEED LESS CALIBRATION, AND
GET INCREASED TRUST AND
INCREASED VALUE FOR HEALTH
DECISIONS.
IT TURNS OUT THAT VALUE OF
HEALTH DECISION MODELING DEPENDS
HOW MUCH YOU ALREADY KNOW AND
THEN IT'S JUST A MATTER OF THE
MATH WHICH IS A VERY GOOD MATH
TECHNIQUE OF INTEGRATING RISKS
OVER TIME FOR THINGS WE CAN'T DO
TRIALS ON.
IN CONCLUSION, WE'VE HAD A
WONDERFUL RUN OF LUCK AND WE'VE
ALSO HAVE DOUG.
I WANT TO HAVE THIS OCCASION TO
THANK HIM.
THIS IS THE THIRD TIME I'VE
PRESENTED, EACH OF THOSE PHASES
I PRESENTED ONCE.
WE'RE NOW AT THIS POINT 40 YEARS
IN, THE REASON I HAVE 40 YEARS
IS BECAUSE WE HAVE SOMEBODY WITH
CONTINUITY WHO HAS SEEN A VISION
OVER THAT TIME.
HE'S HAD ALL THE PRAISE HE
NEEDS, DOESN'T NEED MINE BUT I'M
NO NONSENSE, HE DESERVES MY
THANKS AS WELL.
WE'VE DONE ENOUGH WITH CERVIX
THAT IT'S A MODEL.
KAISER PERMANENTE NORTHERN
CALIFORNIA, OR LIVING IN
AUSTRALIA WE'VE MADE CERVICAL
CANCER A RARE DISEASE, THAT
COULD BE EVERYWHERE, IT'S
ACHIEVABLE, A MATTER OF
IMPLEMENTATION OF WILL.
BECAUSE IT'S SUCH A RISK MAINLY
TO PEOPLE AT RISK, IT'S AN ISSUE
OF JUSTICE.
IT'S ALWAYS BEEN THAT NOW, NOW
INCREASINGLY THAT WAY.
I THANK HIM AND THANK YOU FOR
YOUR ATTENTION AND IF YOU HAVE
ANY TECHNICAL QUESTIONS, NICOLE
IS HERE FOR THE COST
EFFECTIVENESS STUFF.
THANKS.
>> THANK YOU, MARK.
THE FLOOR IS OPEN FOR QUESTIONS
OF MARK.
I'M ALWAYS INTERESTED IN SEEING
THE MATH, HAVING GROWN UP IN THE
MISSISSIPPI DELTA WONDERING WHY
IT PERSISTS AS SUCH A REGION
WITH HIGH RATES, AND CAN THIS
MODEL OR A MODEL LIKE THIS MOVE
THE NEEDLE WHERE THERE'S ISSUES
RELATIVE TO EDUCATION, WHAT IS
HPV, CERVICAL CANCER, HOW WILL
IT IMPACT ME AND MY FAMILY
MEMBERS.
I THINK THERE'S A HUGE GAP,
TRYING TO IMPLEMENT THESE
APPROACHES MAY BE MORE DIFFICULT
IN THOSE TYPES OF SETTINGS.
>> COMPLETELY TRUE.
WHEN WE GO AROUND THE WORLD IN
AFRICA OR WHATEVER AND SAY TRUST
ME, WE'RE GOING TO BE USING HPV
SCIENCE AND ARTIFICIAL
INTELLIGENCE TO PREDICT WHETHER
YOU'RE AT RISK AND NEED SURGICAL
PROCEDURE OR NOT.
YOU FEEL FINE BUT YOU NEED
SOMETHING.
WE'VE BEEN IN NIGERIA AND HAD
THE WHOLE TOWN SAY NO THANKS.
WE HAVE A REALLY ACTIVE HEALTH
COMMUNICATION.
PAUL HAHN AND OTHERS.
WE'VE GOT TO BE ABLE TO
COMMUNICATE THE GIST OF WHAT
WE'RE DOING FOR FAIRNESS AND WE
HAVE TO UNDERSTAND HOW MUCH
PEOPLE WANT TO KNOW.
SINCE THIS IS BASICALLY TAKING
VERY COMPLEX SCIENCE, BOILING IT
DOWN, MAKING IT SIMPLE IN
OUTCOME.
BUT IF PEOPLE WANT TO KNOW WHAT
IT IS, QUITE A TASK.
SO NUMERACY FOR RISK ESTIMATION
IS NOBODY'S FAVORITE.
EVERYONE WOULD RATHER NAME
SOMETHING THAN SAY I HAVE X PER
CORRECT -- X% THIS OR THAT.
WE HAVE A LOT TO DO EVEN WITH A
VERY EFFECTIVE ANSWER, AND I
KNOW THAT'S THE WHOLE THING FOR
IMPLEMENTATION.
PATTY GRAVITT IS DOING WORK ON
THIS PARTICULARLY, HOW MUCH
SHARED DECISION MAKING IS TO BE
EXPECTED AND DESIRED, AND HOW
FLEXIBLE CAN WE MAKE THIS SO
THAT PEOPLE CAN TRUST IN THEIR
CONTEXT.
>> FRANCIS, I SEE YOUR HAND.
>> THAT'S WONDERFUL.
THE CASE IN AFRICA, AND
MARGARET, YOU CAN HELP ME OUT
HERE, IS THAT IT HAPPENED WITH
MAMMOGRAPHY, ALL THESE TESTS
THAT IDENTIFY HIGH RISK AND
POTENTIALLY HIGH RISK IS THE
CONTINUUM.
s YOU COULD THE TEST, IT'S
POSITIVE.
IT ENDS THERE.
UNTIL EFFORTS ARE MADE INTO
INTERVENTION, THERE'S GOING TO
BE AN -- (INDISCERNIBLE) TO
SETTLE IN THESE COUNTRIES,
POSSIBLY EVEN THE MISSISSIPPI
DELTA THAT JOHN WAS TALKING
ABOUT, EITHER WORKING WITH THE
GOVERNMENTS OR WHATEVER TO MAKE
SURE THAT PEOPLE ARE FOUND TO BE
HIGH RISK OR POSITIVE THAT THERE
IS AN OPTION FOR THEM.
IF THAT'S NOT THERE, I THINK
THERE'S GOING TO BE
CONTINUING -- THE QUESTION IS
HOW DOES THAT HELP MY LIFE.
HOW DOES IT CHANGE ANYTHING FOR
ME?
>> NOTICE THE DEVICE THAT IS THE
ABLATION DEVICE IS THE DEVICE
THAT TAKES THE HPV TYPE,
INTEGRATES THE INFORMATION OF
WHAT IT SEES, HAS A CAMERA, AND
SAYS WILL THIS DEVICE WORK FOR
THIS, FOR YOU, OR DO YOU NEED
REFERRAL.
WE TIE THEM TOGETHER.
>> MAMMOGRAPHY DIDN'T PICK UP,
TO HAVE DONE POTENTIALLY.
>> MARGARET?
>> THANK YOU.
>> EXCELLENT PRESENTATION, MARK.
ALL REFERRING CANCERS, LIKEWISE
CERTAIN ARE ASSOCIATED WITH HPV,
WONDERING SOMEONE HAS CONSIDERED
A SIMILAR APPROACH, THERE WERE
PRE-CANCER LESIONS.
SUCH AN APPROACH COULD BE TAKEN
WITH THIS DISEASE AS WELL, ALSO
A VERY EXCITING OPPORTUNITY.
>> THAT'S A SPECIAL AREA OF
INTEREST.
I WOULD POINT OUT THERE IS NO
PRE-CANCEROUS STATE WELL
IDENTIFIED, WE HAVE A VERY LONG
SOJOURN TIME WHERE WE CAN CATCH
AND DESTROY A PRE-CANCER OF THE
CERVIX.
AND WE'RE WORKING ALSO ON THE
ADENOS, GLANDULARES, LEARNING
MORE ABOUT RIGHT NOW.
WE DON'T HAVE WHAT WE'RE
TARGETING, OFTEN THE FIRST SIGN
OF OROPHARYNGEAL, EXTENSION OF
THE NECK, OFTEN NOTHING SEEN SO
FINDING THAT SURROGATE ENDPOINT
PRECURSOR WOULD BE A STEP UP FOR
THAT SCREENING EFFORT.
>> THANKS, MARK.
ONE LAST QUESTION, AS WE
CONTINUE TO SEE DEVELOPMENT OF
NEW NON-INVASIVE APPROACHES FOR
CANCER DETECTION, PRE-CANCEROUS
AS WELL FOR VARIOUS FORMS OF
CANCER, WHERE ARE WE WITH
CERVICAL CANCER?
DO WE SEE NOVEL APPROACHES
COMING ONLINE THAT MIGHT BE EVEN
MORE NON-INVASIVE TO DETECT
THESE CANCERS?
AS WE THINK ABOUT MICROBIOME AND
OTHER APPROACHES TO COME UP WITH
NEW AND BETTER WAYS TO DETECT
THESE PRE-CANCERS.
>> FIRST OF ALL, THE REASSURANCE
GIVEN TO 90% OF PEOPLE BY A
SELF-SWAB, A BACKGROUND, YOU
KNOW, I MEAN IT'S A SPECIAL
PLASTIC BUT IT'S A BEAUTIFUL
LITTLE SWAB THAT'S BEING MADE,
CUSTOM MADE, IT'S -- THE
POSITIVES COME UP IN TEN
MINUTES.
WEAKEST SIGNALS TO 50 MINUTES.
A 10-MINUTE TEST FOR $5, 10 TO
50 MINUTES, DONE BY A WOMAN AND
HANDED IN.
THAT REASSURANCE TWICE IN A
LIFETIME IS A BIG ADVANCE.
THEN THE FACT THAT WE NOW HAVE A
VARIETY OF REALLY GOOD TRIAGE
TOOLS, METHYLATION, DUAL STAIN,
HPV TYPING, A HOST.
IT'S JUST A MATTER OF GETTING
THEM -- IF YOU GIVE ME ENOUGH
MONEY I CAN TELL IF SOMEONE HAS
PRE-CANCER.
IT'S A MATTER OF SCALING AND
ENGINEERING AND GETTING IT TO
PEOPLE WHICH TURNS OUT TO BE
MAJOR CHALLENGES TO GET THINGS
AFFORDABLE.
AND ACCEPTED.
>> YES, KAREN?
>> THANKS YOU SO MUCH.
THIS WAS SUCH A GREAT TALK.
THIS IS ONE WE REALLY CAN CURE,
PREVENT AND IT'S ONE OF THOSE
THAT REMINDS ME OF COLORECTAL
CANCER SCREENING BUT TO JOHN'S
POINT WHEN I LOOK AT FOR
INSTANCE A LOT OF EFFORTS THAT
HAVE BEEN MADE AROUND HEALTH
EDUCATION THINKING SPECIFICALLY
OF THE PROGRAMS THE NCI HAS
FUNDED MANY ARE NOT IN THAT
BLACK BELT IN THE MISSISSIPPI,
ALABAMA, THEY ARE ALL IN THE
NORTHEAST REGION.
MAYBE PERHAPS THERE'S AN
OPPORTUNITY TO THINK ABOUT
CREATING SOME OF THOSE
EDUCATIONAL OPPORTUNITIES.
THIS IS NOT ROCKET SCIENCE.
IN FACT A LOT OF THE
TECHNOLOGIES THAT YOU'RE TALKING
ABOUT, NOT WITH THE A.I. BUT
WITH THE POINT OF SERVICE CARE,
IT'S REVERSE INNOVATION.
THEY HAVE BEEN DOING IT IN
BOTSWANA FOR YEARS, A PROVIDER
IS LOOKING, NOT EVEN A PHYSICIAN
PROVIDER, SOMEONE WHO IS A
LAYPERSON TRAINED TO LOOK AT IT,
THERE'S A PHYSICIAN SOMEWHERE
ELSE LOOKING THAT SAYS OKAY THIS
PERSON NEEDS SOME VINEGAR WHICH
IS ESSENTIALLY TREATMENT, RIGHT?
TO YOUR POINT, LOW COST
INTERVENTIONS THAT REALLY WORK,
THE BIGGEST THING THAT WE CAN
THINK ABOUT IS HOW TO DO THE
EDUCATION, HOW DO WE LEVERAGE
THE RESOURCES THAT ARE ALREADY
OUT THERE PARTICULARLY THE
NON-CHI PROGRAM BECAUSE THAT WAS
ONE OF THE BIG PUSHES.
NCI SAID HPV, GET THE WORD OUT
ABOUT PREVENTION AND SCREENING.
I THINK THIS IS A WONDERFUL,
WONDERFUL EXAMPLE OF INNOVATIONS
THAT UNFORTUNATELY MAY BYPASS
THOSE COMMUNITIES THAT HAVE BEEN
TRADITIONALLY UNDERSERVED AND WE
NEED TO PUT OUR MINDS TOGETHER
TO LEVERAGE OUR CURRENT
RESOURCES TO ADDRESS SOME OF
THOSE ISSUES.
THANK YOU FOR A GREAT TALK.
>> TO TARGET THEM SPECIFICALLY,
GO TO THE HIGHEST BECAUSE THESE
WORK ANYWHERE.
AS SOON AS YOU KNOW A PLACE IS
HIGH RISK TREAT IT LIKE THE
EPIDEMIC THAT IT IS.
GO THERE.
AND BREAK IT DOWN FROM THERE
BECAUSE REDUCING SOMETHING 10%
FROM A HIGH RATE SAVES A LOT
MORE LIVES THAN REDUCING
SOMETHING 10% FROM A LOW RATE.
>> I COULDN'T AGREE MORE, KAREN.
I THINK THERE'S A GRASSROOTS
EFFORT THAT WILL BE NEEDED TO
ADDRESS THIS.
AND SOME OF THESE PLACES LIKE
THE MISSISSIPPI DELTA.
SUSAN?
>> JUST BECAUSE I SO AGREE, THIS
IS AN IMPORTANT POINT, IN
THINKING ABOUT PARTNERS WHEN YOU
WERE WORKING IN THESE
LOW-RESOURCE SETTINGS
COMMUNITY SETTINGS, THE FOLKS
SERVING THOSE COMMUNITIES, NICE
TO SEE LIKE I'VE SEEN IN
LEGISLATION WITH A PUSH TO HAVE
THOSE CENTERS ACTUALLY BE ABLE
TO RECEIVE THOSE TYPES OF FUNDS
TO DO SOME OF THE HEALTH
EDUCATION AND OUTREACH BECAUSE
THEY ARE THE TRUSTED PARTNERS IN
THE COMMUNITY ALREADY THERE.
SO, I WOULD LOVE TO SEE THIS
ADVANCE IN THE U.S. AND IN
UNDERSERVED AREAS.
>> THAT'S TRUE.
>> I AGREE TOTALLY.
ELECTRA?
>> THANKS, MARK.
HI, MARK.
GOOD TO SEE YOU.
THANKS FOR ALL YOU DO.
SO, SOMEBODY WHO HAS WORKED FOR
OVER 30 YEARS IN THIS AREA OF
CERVICAL CANCER, I CAN TELL YOU
IT'S GOING TO TAKE MORE THAN
JUST EDUCATION.
EVEN ACCESS.
W.H.O., SEVERAL YEARS AGO SAID
THERE'S THREE PILLARS THAT LED
LEAD TO ELIMINATION, SCREENING
AND TIMELY FOLLOW-UP.
IN THE UNITED STATES WE'RE
FALLING SHORT, BIG TIME, OF THE
LAST ONE.
WHEN I GOT MY DISSERTATION
FINISHED IN 1989, THE RATE OF
FOLLOW-UP OF ABNORMAL PAPS WAS
60%.
WENT TO A MEETING A COUPLE
MONTHS AGO, THE RATE IS STILL
60% FOR WOMEN WITH ABNORMALS.
THAT'S JUST UNACCEPTABLE.
AND UNTIL WE UNDERSTAND THAT
THESE WOMEN ALL COUNT, THAT WE
HEALTH CARE PROVIDERS ARE
RESPONSIBLE FOR FOLLOW-UP,
TIMELY AND PROPER FOLLOW-UP OF
THE WOMEN, THAT WE NEED TO FOCUS
ON THIS.
WE'RE NOT
WE'RE NOT GOING TO GET ANYWHERE,
DOESN'T HELP TO SCREEN WITHOUT
FOLLOW-UP.
UNFORTUNATELY WOMEN WHO DON'T
SPEAK ENGLISH ARE EXPERIENCING A
HUGE DISPARITY BECAUSE A LOT OF
INFORMATION IS IN ENGLISH, NO
HELP TO GET THE APPROPRIATE
FOLLOW-UP SERVICES.
I THINK WE CAN ELIMINATE
CERVICAL CANCER BUT THERE HAS TO
BE A WILL AND EVERYBODY HAS TO
THINK ABOUT IT, AND WANT TO DO
IT, AND NOT THINK OF CERVICAL
CANCER AS SOMETHING THAT ONLY
CERTAIN WOMEN GET.
AND I HAVE HEARD THAT AND WE'VE
GOT TO CHANGE WAIT WE THINK
ABOUT IT. ALSO HELP TO INCREASE
HPV VACCINATION RATES WHICH
SUFFERED DON'T COVID AND
CONTINUE TO SUFFER.
WE WANT TO MAKE A DIFFERENCE IN
CANCER, START WITH THE ONE WE
CAN, PERHAPS A FEW OTHER CANCERS
ALONG THE WAY.
BUT THANK YOU, MARK AND DOUG,
FOR YOUR WORK ON THIS.
IT'S REALLY SPECTACULAR AND
WE'VE JUST GOT TO NOW IMPLEMENT
IT BUT IMPLEMENT IT ON THE
MULTI-LEVEL FOCUS AND NOT JUST
THINK ABOUT ACCESS AND EDUCATION
BECAUSE THERE'S CULTURE, THERE'S
FEAR, THERE'S A WHOLE LOT OF
THINGS THAT WE NEED TO FOCUS ON
AND WE'RE DOING IT.
WE'VE BEEN DOING IT NOW IN
APPALACHIA FOR MANY YEARS, IT'S
NICE THEY DON'T HAVE THE HIGHEST
RATES ANY LONGER, STILL IN THE
MID, BUT WE HAVE A LONG WAY TO
GO TO ELIMINATE THIS CANCER.
ACHIEVABLE BUT WE HAVE TO WORK
TOGETHER.
>> YEAH, EXCELLENT PERSPECTIVE
FROM SOMEONE WHO HAS BEEN DOING
THIS A LONG TIME.
THANKS.
I STILL THINK EDUCATION AS WE
TALK ABOUT FEAR AND TRUST, YOU
KNOW, CULTURE, RIGHT?
YOU KNOW, PEOPLE HAVE NO IDEA
WHAT HPV IS IN THE FIRST PLACE,
YOU KNOW, WE HAD PEOPLE WHO
DON'T -- VACCINATION CHALLENGES
WITH COVID, AND EVERYONE, IT WAS
EVERYWHERE, RIGHT?
AND FOR A VIRUS THAT CAUSES
CANCER, SO FEW PEOPLE IN THE
MISSISSIPPI DELTA HAVE ANY CLUE
WHAT IT IS IN THE FIRST PLACE.
THERE'S PERSISTENT EXPOSURE TO
THE VIRUS.
SO GREAT POINTS.
AND THEN YOUR COMMENT, ELECTRA,
ABOUT FOLLOW-UP IS SIMILAR TO
COLORECTAL CANCER AND SCREENING
AND LUNG CANCER SCREENING, ALL
THESE THINGS.
IF YOU CAN FIND IT, GREAT.
BUT WHAT HAPPENS IF YOU CAN'T DO
ANYTHING ABOUT IT LATER?
SO THESE ARE ALL GREAT POINTS.
BUT THANK YOU AGAIN, MARK.
THAT WAS SUCH A FABULOUS
PRESENTATION.
AND THE BOARD THANKS YOU FOR
YOUR TIME AND YOUR EFFORTS.
I THINK WE'RE RIGHT ON TIME,
PAULETTE.
I THINK WE'RE SUPPOSED TO GO
INTO BREAK NOW.
>> YES.
>> SO, THERE'S A 30-MINUTE BREAK
FOR THIS OPEN SESSION.
HOWEVER, THOSE AT THE VIRTUAL
TABLE CAN TAKE A FIVE-MINUTE
BREAK, DON'T DISCONNECT, JUST
TURN OFF YOUR CAMERAS AND MUTE.
IF YOU'RE NOT MUTED I.T.
PROFESSIONALS WILL MUTE
EVERYONE.
EVERYONE ELSE SHOULD COME BACK
AT 3:25.
FOR THOSE AT THE VIRTUAL TABLE
JUST TAKE A FIVE-MINUTE BREAK.
>>I THINK WE'RE BACK IN
SESSION.
AND WE'RE NOW IN THE SESSION FOR
ONGOING AND NEW BUSINESS, AMONG
WHICH THERE WERE TWO NCAB
SUBCOMMITTEE MEETINGS HELD
EARLIER TODAY, AND CHAIRS WILL
GIVE THEIR REPORTS.
WE'LL HAVE THE FIRST REPORT FROM
AMY HEIMBERGER ON EXPERIMENTAL
THERAPEUTICS?
>> THERAPEUTICS BEGAN BY GIVING
AN UPDATE WITH REGARDS TO
PREVIOUS MANDATE UNDER DR.
SHARPLESS.
THERE WAS SOME CONCERNS WITH
REGARDS TO DEVELOPMENT 6
CELLULAR THERAPEUTICS AND HOW
THE NCI COULD DO THAT BETTER.
ROSE ARGININE PRESENTED AN
UPDATE ON CELLULAR THERAPEUTICS
FOR SOLID CANCERS, THIS INCLUDED
A NUMBER OF CONFERENCES AS WELL
AS A WHITE PAPER THAT WAS
PUBLISHED THAT IDENTIFIED AREAS
ON UNMET NEED FOR ADVANCING
CELLULAR THERAPIES FOR SOLID
CANCERS.
THIS ULTIMATELY RESULTED IN
THREE COMPANION FUNDING
OPPORTUNITY ANNOUNCEMENTS THAT
CAME FOR THE CANCER ADOPTIVE
CELL THERAPY NETWORK, POSTED,
ONE WILL INCLUDE A COOPERATIVE
AGREEMENT UG3 AND UH3 THAT WILL
INCLUDE ADULT AND PEDIATRIC
CANCERS AND IT'S GOING TO BE
MANAGED AS A SINGLE U24
COORDINATING SITE SUPPORTED BY
THE CELL CORE AT THE FREDERICK
NATIONAL LABORATORY FOR CANCER
RESEARCH.
AND THERE'S A WEBINAR FOR THAT
ON SEPTEMBER 7.
THE NEW DISCUSSION POINTS THAT
WERE BROUGHT UP ON OUR
SUBCOMMITTEE MEETING THIS
MORNING WERE A CONSIDERATION FOR
INCREASING OUR TRANSLATIONAL
RESEARCH TRAINING.
AND WE BEGAN BY INTRODUCING THE
NEED.
THIS WAS THROUGH THE FACT THAT
THERE'S A PROGRAM IN THE CANCER
CENTER THROUGH THE NCI
DEVELOPMENTAL THERAPEUTICS
PROGRAM WHERE YOU CAN GET
CONFIDENTIAL GUIDANCE.
IT'S BEEN OPERATIONAL FOR 3.5
YEARS.
SO FAR THERE'S BEEN A TOTAL OF
264 REQUESTS, 149 149
CONSULTATIONS ACROSS EVERY STATE
FROM PRE-CLINICAL TOXICOLOGY,
EFFICACY, PROOF-OF-CONCEPT
STUDIES, ET CETERA.
THERE'S CLEARLY A NEED BY PEOPLE
WORKING IN THE TRANSLATIONAL
CONTINUUM.
BUT I ALSO PROVIDED SOME
ANTIDOTES WITH THE FACT THAT
EVEN AT A MAJOR CANCER CENTER
THAT THERE'S MANY ISSUES THAT
ARISE IN THE TRANSLATIONAL
THERAPEUTIC PIPELINE.
AND THESE INCLUDE THINGS LIKE
INVESTIGATORS, EVEN SEASONED
INVESTIGATORS NOT UNDERSTANDING
THAT REQUIREMENT FOR FILING
PROVISIONAL PATENT PRIOR TO
PUBLIC DISCLOSURE, UNDERSTANDING
COMPETITIVE LANDSCAPE, CLINICAL
INDICATIONS, ET CETERA.
SO THIS MEETING THIS MORNING WAS
TO EXPLORE IDEAS AROUND
POTENTIALLY DEVELOPING EARLIER
STAGE THERAPEUTICS OR
TRANSLATIONAL THERAPEUTICS,
EDUCATIONAL CURRICULUM.
BECAUSE THAT WAS THE
CONSIDERATION, WE HAD DR.
BUBBLER, DIRECTOR FOR THE CENTER
OF CANCER TRAINING, PROVIDED US
WITH INFORMATION WITH REGARDS TO
INTRAMURAL INTERAGENCY ONCOLOGY
TASK FORCE FELLOWSHIP.
THIS IS AN INTERESTING PROGRAM,
THE IT'S A COMBINATION,
TWO-YEAR IN-HOUSE FELLOWSHIP TO
TRAIN SCIENTISTS IN RESEARCH AND
RESEARCH-RELATED REGULATORY
PROCESSES.
NOW, I'M GOING TO EMPHASIZE THIS
IS ON THE SORT OF RAPID
TRANSLATION INTO CLINICAL TRIALS
SORT OF PART OF THE CONTINUUM.
SINCE THE INITIATION, HE'S HAD A
TOTAL OF 70 GRADUATES TO DATE,
MANY OF THESE HAVE ACTUALLY
HAD -- WENT ON TO SERVE IN THE
FDA OR IN THE BIOMEDICAL
INDUSTRY.
THERE'S A TOTAL OF 1572 ACTIVE
CANCER TRAINING AWARDS, IN
K12s, R25s, K08s, ET
CETERA.
AND OF THOSE, 166 SUPPORT
CLINICAL TRIALS.
I WOULD LIKE TO NOTE THESE ARE
TRAINING GRANTS IN CANCER, THEY
DON'T NECESSARILY INFLUENCE OR
EDUCATE ON THAT TRANSLATIONAL
CONTINUUM, AT THE VERY EARLY
STAGE.
IN OTHER WORDS, HOW YOU VET
SOMETHING, HOW YOU PICK LEAD
TEST ARTICLES, ET CETERA.
SO, WE'VE GOT A VERY NICE SORT
OF PROGRAM AT THE NCI ON THE
RAPID TRANSLATION INTO CLINICAL
TRIALS STAGE OF THINGS.
HE ALSO BROUGHT UP THE METHODS
AND CLINICAL CANCER RESEARCH
WORKSHOP.
I WAS ONE OF THE FIRST OR
PROBABLY SECOND YEAR PARTICIPANT
WHEN IT WAS INITIATED A WHILE
AGO.
AND THIS IS REALLY WHERE AN
INVESTIGATOR BRINGS TO THIS
PARTICULAR WORKSHOP, IT'S A
WEEK-LONG COURSE, CLINICAL TRIAL
CONCEPT, AND THEN THEY HAVE
EXPERTS THAT COME IN AND HELP
WORK THROUGH THE CLINICAL TRIAL.
AGAIN, IT'S RIGHT AS YOU'RE
TRANSITIONING INTO CLINICAL
TRIAL.
SO, THE SUBCOMMITTEE, WE
DISCUSSED THE SPECIFIC
CHALLENGES ASSOCIATED WITH
TRANSLATIONAL RESEARCH.
AND THIS INVOLVED EDUCATION
AROUND THIS SORT OF ENDEAVOR.
FIRST OF ALL, THERE WAS A
DISCUSSION WITH REGARDS TO
INCREASING THE DIVERSITY OF THE
RESEARCH WORKFORCE WHICH
EVERYONE ON THIS BOARD AGREES IS
A KEY ISSUE.
THE MULTI-FACETED CHALLENGES
TRANSLATIONAL RESEARCH
INSTITUTIONAL SUPPORT FOR
INTELLECTUAL PROPERTY NEEDS FOR
THE INVESTIGATORS RESEARCHERS
NOT REALLY UNDERSTANDING THE
PROCESS, IN OTHER WORDS, YOU
KNOW, THE ACTUAL SORT OF PROCESS
YOU GO THROUGH WHEN PHARMA LOOKS
AL THESE KINDS OF THINGS.
AND THEN ADDITIONALLY THERE'S A
LOT OF LACK OF INSTITUTIONAL
INFRASTRUCTURE TO SUPPORT GOOD
LABORATORY PRACTICES, GOOD
MANUFACTURING PRACTICES, ET
CETERA.
AND THEN IT ALSO COMES DOWN TO
LACK OF EXPERTISE IN MULTIPLE
DOMAINS, THOSE INCLUDE BUSINESS
UNDERSTANDING, SORT OF WHETHER
YOU'RE GOING TO REAP YOUR RETURN
ON INVESTMENT WHEN DEVELOPING
SOMETHING, LEGAL ASPECTS OF
INTELLECTUAL PROPERTY, ET
CETERA.
AND BUSINESS ASPECTS.
SO, CERTAINLY THOSE KINDS OF
THINGS PLAY A ROLE IN PHARMA
WHEN THEY DEVELOP A DRUG, AND
THOSE ACADEMIC CENTERS ARE NOT
AWARE OF THESE KEY COMPONENTS AS
THEY ARE DEVELOPING THERAPEUTICS
AND I THINK WE HAVE A VARIETY OF
LOST INITIATIVES BECAUSE OF THE
LACK OF UNDERSTANDING.
SO, WE HAD A NUMBER OF KEY STEPS
THAT WERE ACTUALLY IDENTIFIED,
IF THIS IS SOMETHING THAT THE
GROUP WISHES TO OR IF THERE'S
SIGNIFICANT INTEREST IN
DEVELOPING THIS FURTHER.
THERE COULD BE DEVELOPMENT OF
NCI CURRICULUM THAT REALLY SORT
OF IS MORE FOCUSED ON THE EARLY
PARTS OF THE EDUCATIONAL
TRANSLATIONAL CONTINUUM.
WE COULD CERTAINLY ASSAY OR
ASSESS FROM CANCER CENTERS
DIRECTORS THE NEEDS OF THE
VARIOUS CANCER CENTERS, SPECIFIC
LIVE SORT OF THE AREAS THAT THEY
FEEL THEY ARE REALLY LACKING.
ONE OF THE ADVANTAGES OF HAVING
IT CENTRALIZED, REDUCES
DUPLICATION OF INFRASTRUCTURE,
COULD HARMONIZE, COULD BRING IN
THE LEADING EXPERTS IN THESE
DOMAINS TO REALLY SORT OF FOSTER
AND MAKE SURE THAT THE TRAINING
IS DONE BY THE BEST POSSIBLE
PERSON.
THIS COULD BE ARCHIVED, SO THAT
THESE TALKS OR THESE
INSTRUCTIONAL ACTIVITIES ARE
AVAILABLE TO THE TRAINEES.
WE COULD ALSO CONSIDER THIS
BEING SUPPORTED BY ARPA-H.
THIS WAS ACTUALLY A COMMENT MADE
IN DR. BARKER'S SUBSEQUENT
SESSION, BUT TRANSLATIONAL
RESEARCH IS NOT NATIONALLY
CONFINED TO CANCER, THERE'S
ALZHEIMER'S, NEUROSCIENCES, MANY
TYPES OF DISEASE PROCESSES THAT
WOULD BENEFIT FROM UNDERSTANDING
HOW TO REALLY OPTIMIZE THE
SUCCESS OF TRANSLATIONAL
RESEARCH.
AND SO I THINK THOSE WERE THE
KEY SORT OF DISCUSSION POINTS,
CERTAINLY IF ANYBODY ELSE WOULD
LIKE TO ADD THINGS THAT I'VE
MISSED I'M HAPPY TO HAVE YOU
VOLUNTEER.
>> GREAT, AMY.
LOOKS LIKE HOWARD HAS HIS HAND
UP.
>> SO, I JUST WANTED TO SHARE
ANOTHER POINT THAT I'M NOT SURE
WAS EMPHASIZED.
AND THAT IS THE -- THERE HAVE
BEEN OTHER INITIATIVES TRYING
TO -- MY UNDERSTANDING, TO
ADVANCE THE SAME GOALS OF
HELPING TO OPTIMIZE
TRANSLATIONAL RESEARCH FROM
ACADEMIA INTO LET'S SAY BROADER
ACCESS OR COMMERCIALIZATION,
IMPACT ON PATIENT CARE.
AND THE LACK OF UNDERSTANDING
WAS ACTUALLY A SURVEY TOPIC IN
EUROPE AMONG THE EUROPEAN
INVESTIGATORS WHO ACTUALLY
ANSWERED, NUMBER ONE, BEING THE
UPDATED -- THE NEED FOR TRAINING
AND UPDATED REGULATORY SCIENCES.
AND RESPONDING TO THAT, THE
REGULATORS STARTED SOMETHING
CALLED THE STARS INITIATIVE
WHICH IS NOW BEING IMPLEMENTED
GOING FORWARD.
AND I DON'T KNOW IF IT'S IN
RESPONSE BUT THE FDA, THE
ONCOLOGY CENTER OF EXCELLENCE
LAUNCHED PROJECT CATALYST,
SOMETHING SIMILAR.
I WANT TO BRING THOSE UP TO THE
GROUP BECAUSE I THINK THESE ARE
ALSO VERY IMPORTANT APPROACHES
THAT SHOULD BE, LET'S SAY,
FOLLOWED OR MAYBE LEARNED FROM
OR ENGAGED WITH.
I THINK NCI PEOPLE ARE ALREADY
ENGAGED IN PROJECT CATALYST
BECAUSE OF THEIR CLOSENESS WITH
THE FDA STAFF.
>> GREAT POINT, HOWARD, IN TERMS
OF NOT REINVENTING THE WHEEL,
ARE THERE MODELS THAT WE COULD
LOOK AT THAT COULD BE TWEAKED.
AND INTERSECTIONS BETWEEN
PROGRAMS.
>> SURE.
I MEAN, I THINK ESPECIALLY FOR
UNDERSERVED RARE INDICATIONS,
PEDIATRICS, ET CETERA, WE HAVE
TO COLLABORATE.
>> ABSOLUTELY.
>> WITH THE EUROPEANS AND OTHERS
THAT CAN DO QUALITY TRIALS AND
WANT TO COLLABORATE WITH US.
AND ON THE TOPICS LIKE
BIOMARKERS, THERE'S BEEN
DIVERGENCE, PROVIDING
OPPORTUNITY FOR HARMONIZATION, A
WIN-WIN, FOR THE SUPER RARE
INDICATIONS, HELPING BOTH
POPULATIONS ACROSS -- YOU KNOW,
ACROSS THE GLOBE.
>> GREAT.
THANKS, HOWARD.
ANY OTHER QUESTIONS OR COMMENTS
RELATED TO THE EXPERIMENTAL
THERAPEUTICS SUBCOMMITTEE?
>> I THINK IT WAS ONE POINT I
NEGLECTED TO ADD IN, MY
APOLOGIES.
ONE OF THE THINGS THAT DR.
VOGLER BROUGHT UP, WAS THAT THE
CLINICAL TRIALS WAS PARTICULARLY
EFFECTIVE WHEN THE STUDENTS
BROUGHT IN SORT OF A REAL LIFE
EXAMPLE.
SO THE PROGRAM COULD, YOU KNOW,
IF WE'RE TALKING ABOUT EARLIER
IN THAT CONTINUUM PIPELINE, WE
COULD HAVE INVESTIGATORS
INVOLVED THAT LET'S SAY THE
TARGET THEY WANT TO DEVELOP AND
IN OTHER WORDS THEY HAVE, YOU
KNOW, A REAL EXAMPLE THEY WANT
TO IMPLEMENT THROUGH THE
PROGRAM, HE THOUGHT THAT WOULD
BE MUCH MORE EFFECTIVE STRATEGY
AS OPPOSED TO JUST A GENERAL
CURRICULUM JUST STRAIGHT, YOU
KNOW, FORWARD, WITH NO OTHER
WORKING EXAMPLE.
>> YEAH, KIND OF -- THERE'S
DIDACTIC AND PRACTICAL.
THAT'S GREAT.
CAN YOU LOWER YOUR HAND IF YOU
DON'T HAVE ANOTHER QUESTION SO
WE CAN -- OKAY.
IF THERE ARE NO OTHER QUESTIONS
OR COMMENTS PERTAINING TO
EXPERIMENTAL THERAPEUTICS, THAT
SUBCOMMITTEE, THE SECOND
SUBCOMMITTEE REPORT WILL BE
GIVEN BY DR. ANN BARKER WHO
CHAIRS SUBCOMMITTEE ON PLANNING
AND BUDGET.
ANN?
>> ALL RIGHT, THANK YOU.
THANKS TO THE COMMITTEE TODAY.
WE HAD A GREAT DISCUSSION.
AND TO OUR EXECUTIVE SECRETARY,
PATRICK MCGAREY, WHO ALWAYS DOES
A GREAT JOB FOR BRINGING US A
LOT OF DETAILS ABOUT PLANNING
AND BUDGET, WHICH IS COMPLEX.
SO, WE STARTED OUR MEETING WITH
SOMETHING IS CLOSE TO MY HEART,
WE'RE AT A POINT IN CANCER
RESEARCH SEEING ENORMOUS
INTEREST ACROSS LOTS OF FIELDS
OF RESEARCH THAT ACTUALLY
MAINLINE CANCER RESEARCH WITH
THINGS THAT REPRESENTATIVE
CONVERGENCE WITH CANCER WHICH WE
NEED, AND I THINK MAYBE DUE TO
THE FIRST MOONSHOT WE HAVE AN
INFLUX OF APPLICATIONS, STARTING
ALL THE WAY BACK IN 2013, AND
50% INCREASE WHICH IS UNHEARD
OF.
AND THERE'S NOT ANOTHER MEMBER
OF THE NIH THAT HAS EVEN
ANYTHING CLOSE TO THAT KIND OF
SUBMISSION.
WE TALKED ABOUT THAT IN TERMS OF
ITS IMPACT ON EVERYTHING,
ESSENTIALLY, YOU KNOW, HOW DO WE
KEEP THE PAYLINES WHERE WE WANT
THEM TO BE, WHAT ARE OUR SUCCESS
RATES.
THE THING CONCERNING HERE IS
THAT THIS IS AN INFLECTION POINT
I THINK WHERE SO MUCH IN CANCER
RIGHT NOW IS SO EXCITING, SO
MANY PEOPLE, ESPECIALLY YOUNG
PEOPLE, AND WE DON'T WANT TO
DISCOURAGE THEM.
NIH DOES EVERYTHING THEY
POSSIBLY CAN TO MAKE SURE THAT
THOSE COMPETITIVE GRANTS ARE
FUNDED.
SO, WE MOVED ON FROM THERE TO
TALK ABOUT 2022, WITH PATRICK'S
GUIDANCE.
ESSENTIALLY, IT'S PRETTY MUCH IN
THE BOOKS WITH ANOTHER MONTH TO
GO BUT LOOKS AS THOUGH OUR
APPROPRIATION IS GOING TO BE
6.9 MILLION, $6.7 MILLION IN THE
BASE, THINGS THAT ADD INTO THAT
NUMBER OF 6.9 THAT MAY BE
FUNDABLE, AND THEY MAY NOT BE
WITH US FOREVER AND ONE OF THOSE
ACTUALLY IS THE CANCER MOONSHOT
MONEY WHICH ACTUALLY THE LAST
YEAR IS NEXT YEAR, SO WE ALL
HAVE TO THINK ABOUT THAT.
LOTS OF PEOPLE ARE THINKING
ABOUT IT.
SO FINAL YEAR OF THE MOONSHOT
AND WE'RE YET TO SEE HOW
APPROPRIATIONS FOR THE MOONSHOT
IS GOING TO PLAY OUT IN MOONSHOT
2.0.
IT'S IN PROCESS.
SO, THE METRICS WILL BE DONE.
I SUSPECT CLOSE TO THE END OF
THE YEAR FOR 2022, BUT IT LOOKS
AS THOUGH WE WERE ABLE TO
SUSTAIN OUR PLAN FOR FUNDING AT
THE PAY LINES WE HAD THE
PREVIOUS YEARS.
AND I THINK THAT'S GREAT NEWS.
WE ACTUALLY HOPE THAT WE CAN
KEEP THAT UP AND WE GET TO 15%
BY 2025.
THAT'S OUR GOAL.
THAT'S GOING TO BE HARD.
I THINK EVERYBODY NEEDS TO
UNDERSTAND EVERYTHING AFFECTS
THIS.
CERTAINLY INFLATION THAT WE
DIDN'T TALK ABOUT TODAY IS A BIG
DEAL.
RAISING PAYLINES AS PATRICK
POINTED OUT IS A HEAVY LIFT.
JUST FROM LAST YEAR TO THIS
YEAR, THAT'S A $39 MILLION PACK
TO CAPTURE THAT ON HIS BACK,
GOING UP THE MOUNTAIN.
THAT'S ADDITIONAL $39 MILLION
THAT WE HAVE TO CARRY.
AND SO EVERY YEAR THAT WE WANT
THE PAYLINE TO GO UP WE HAVE TO
LOOK AT HOW MUCH ARE WE
COMMITTING IN THE OUT YEARS, SO
THAT'S ANOTHER THING, YOU THINK
OUR GRANTS ARE FOUR AND FIVE
YEARS AND INCREASINGLY SEVEN, AS
PEOPLE CONVERT TO R 37s.
SO, A LOT TO THINK ABOUT HERE IN
TERMS OF OUR NEW DIRECTOR OF THE
NCI COMING IN, AND HOW WE'RE
GOING TO OPTIMIZE PAYLINES.
2023 IS STILL UP IN THE AIR,
HOPEFULLY THE SENATE AND HOUSE
COMING TOGETHER AFTER THE
ELECTION, NOT BEFORE THE
ELECTION.
EVERYBODY IS GOING HOME SHORTLY
TO CAMPAIGN.
BUT CURRENTLY, IT'S LOOKING
GOOD.
I MEAN, I THINK IT WAS PROPOSED
IN THE SENATE, AN WHAT'S
PROPOSED IN THE HOUSE, ARE NOT
THE SAME THING BUT THEY ARE
CLOSE.
AND SO THEY ARE ALSO LOOKING AT
ARPA-H.
AND I COME BACK TO ARPA-H IN
JUST A MINUTE, BUT OUR BUDGET
ACTUALLY CURRENTLY IN THE SENATE
IS I THINK 4.2% IN THE HOUSE AND
6.7% IN THE HOUSE, 4.2% IN THE
SENATE, AND IT WILL BE SOME
WHETHER IN THE MIDDLE.
WE COULD GUESS, BUT THAT'S
ACTUALLY PRETTY GOOD.
I THINK THE ISSUE WITH US IS,
YOU KNOW, LOSING MOONSHOT MONEY
AND AFTER NEXT YEAR.
ARPA-H CONTINUES TO BE A REALLY
INTERESTING FOOTBALL THAT KEEPS
GETTING TOSSED AROUND.
AND IT HASN'T GOT AN WHOLE LOT
BETTER.
SO, THERE ARE TWO PROPOSALS FOR
FUNDING THIS IN TERMS OF 2.75
AND A MILLION TO ADD, IN TWO
DIFFERENT TIMES.
THE HOUSE AND SENATE STILL HAVE
HAVEN'T AGREED ON WHAT THE LEVEL
OF FUNDING FOR ARPA-H SHOULD BE.
AND I AM NOT SURE HOW THEY ARE
GOING TO COME TO THAT.
THAT'S AN INTERESTING QUESTION
IN TERMS OF AUTHORIZING THAT AND
GETTING IT PAID.
BUT WE ALSO DON'T HAVE A
DIRECTOR.
AND WE ALSO DON'T HAVE AN
AGREEMENT ON WHERE ARPA-H IS
GOING TO BE.
WE THOUGHT WE HAD AN AGREEMENT
BECAUSE WE THOUGHT IT WAS GOING
TO BE AT NIH FOR A WHILE BUT IT
LOOKS LIKE CONGRESSMEN ESHOO
FROM CALIFORNIA AND HER
COLLEAGUES SAY NO, SO THAT'S AN
ONGOING CONVERSATION.
I THINK THIS IS IMPORTANT
LEGISLATION FOR NCI.
I THINK A LOT OF THE THINGS WE
TALKED ABOUT IN EXPERIMENTAL
THERAPEUTICS FOR EXAMPLE COULD
BE PAID OUT OF THAT KIND OF
FUNDING.
WE TALKED ABOUT THE MOONSHOT,
IT'S THE REALLY ENERGIZED
CATALYZED MOONSHOT 2.0, NCI HAS
SUBMITTED VERY GOOD IDEAS FOR
THAT AND ESPECIALLY MULTIPLE
CANCER TESTING, REALLY UPGRADING
AND RELAUNCHING SORT OF NEXT GEN
CLINICAL TRIALS.
BUT DOUG IN OUR DISCUSSION MADE
THE POINT THAT REALLY IF YOU
LISTEN TO PRESIDENT BIDEN
ESTABLISHING CANCER CABINET,
SETTING UP THE MOONSHOT, HE'S
REALLY INTERESTED IN DOING MORE
ABOUT CARE DELIVERY.
AND CHANGING THE LIVES OF
PATIENTS.
MOONSHOT 1.0 WAS ESSENTIALLY
ABOUT LET'S ACCELERATE RESEARCH.
THIS IS ABOUT GETTING WHAT WE
KNOW TO PATIENTS AND DOING IT
FASTER, BETTER, AND I THINK NCI
HAS SOME VERY GOOD IDEAS IN THAT
REGARD.
WE DID AS A GROUP COMMENDED DOUG
ON HIS PUBLIC SERVICE, BEYOND
THE VEIL IN TERMS OF HOW MUCH
HE'S DONE ESPECIALLY IN THESE
DIFFICULT BUDGET TIMES.
I DON'T THINK THAT'S GOING TO
CHANGE GOING FORWARD FOR OUR NEW
DIRECTOR.
YOU KNOW, I HONESTLY THINK --
ONE OTHER CONVERSATION WE HAD,
BECAUSE I SEE DR. SHRIVER ON THE
PANEL TODAY, WE PACT ABOUT THE
PACT ACT AS AN EXAMPLE OF WHERE
NCI CAN PARTNER WITH ANOTHER
AGENCY.
FOR EXAMPLE, PACT ACT AS MANY OF
YOU HEARD REALLY GOT A LOT OF
PRESS TO LOOK AT CARCINOGENESIS
AND OTHER EFFECTS IN SERVICE
PEOPLE WHO SERVED IN VARIOUS
FIELDS OF COMBAT.
IT'S AN INTERESTING APPROACH TO
MAKING LIVES BETTER FOR PEOPLE
ESPECIALLY IN THE MILITARY WITH
CANCER.
THIS IS THE PLACE WHERE IT'S
GOING TO BE ABOUT
CARCINOGENESIS, SO VERY COMPLEX
MIXTURES, SO IT'S A GOOD PLACE,
I KNOW NCI IS THINKING HOW THEY
MIGHT PARTNER ON THAT.
AND THERE ARE OTHER PIECES OF
LEGISLATION THAT ARE SIMILAR IN
TERMS OF OFFERING NCI
PARTNERSHIPS THAT I'M SURE WE'LL
FOLLOW UP ON.
SO, WE TALKED ABOUT A LOT IN
THIS PLANNING AND BUDGET MEETING
BUT ONE THING I'VE BEEN TALKING
ABOUT QUITE A LOT, MAYBE TOO
MUCH, BUT I THINK MULTI-CANCER
TESTING IS SOMETHING THAT WE
CAN'T IGNORE AS I SAID EARLIER.
IT'S A PARADIGM SHIFT, IF YOU
CAN DETECT CANCER VERY, VERY
EARLY THAT SOUNDS GREAT, BUT
THERE'S A LOT OF THINGS THAT
FLOW FROM THAT.
AND I THINK I SUGGESTED AT THE
LAST NCAB MEETING THIS MAY BE AN
AREA WHERE THE NCAB SHOULD
REALLY LOOK AT WE'RE DOING
CLINICAL TRIALS, THE ONLY GROUP
DOING CLINICAL TRIALS WITH
SURVIVAL ENDPOINTS IN THE
MULTI-CANCER DETECTION SPACE.
THAT'S GOING TO BE CRITICALLY
IMPORTANT BUT THERE ARE LOTS OF
OTHER PIECES OF THIS THAT WILL
INVOLVE THE NCI SO ANYTHING THE
NCAB CAN DO TO OFFER ADVICE
WOULD BE WORTH THINKING ABOUT,
MAYBE A STUDY FROM THE NCAB.
WE HAD SOME QUESTIONS, PATRICK
ACTUALLY SHARED LINKS, IF YOU'RE
INTERESTED WE'VE HAD QUESTIONS
ON, YOU KNOW, HOW DO I FIND OUT
HOW MUCH FUNDING IS GOING INTO
MY CANCER.
THIS IS AN ADVOCATE QUESTION,
ACTUALLY.
AND THERE ARE -- I DON'T HAVE
THEM EASILY TO SHOW YOU HERE BUT
THERE ARE PLACES YOU CAN GO ON
THE WEBSITE AND LOOK THAT UP.
AND SO ANYWAY, WE ADJOURNED.
IT WAS A VERY ACTIVE
CONVERSATION WITH GREAT HOPES
FOR 2023 AND SPECULATION ABOUT
2024.
THERE'S AN ELECTION COMING UP,
AND NOBODY KNOWS WHERE IT MAY
ALL END UP, BUT I THINK NCI IS
WELL POSITIONED CERTAINLY WITH
THE CONGRESS.
THEY THINK A LOT OF OUR
INSTITUTE AND CERTAINLY THE NIH
AND WE HAVE A LOT OF FRIENDS.
SO I'M OPTIMISTIC.
THANK YOU, MR. CHAIRMAN.
THAT'S MY REPORT.
>> THANK YOU, DR. BARKER.
ANY QUESTIONS OR COMMENTS?
RELATIVE TO BUDGET AND PLANNING?
FOR ME IT'S THE PLANNING PART,
HOW FAR OUT YOU CAN BEGIN TO
PLAN OR THINK ABOUT THINGS,
AGAIN CONSIDERING MOON SHOOT,
YOU KNOW, HOW DOES THAT FUNDING
OCCURRED?
WE KNOW HOW IT OCCURRED
PREVIOUSLY THROUGH 21ST CENTURY
CURES ACT, AND WILL IT BE A
SIMILAR MODEL GOING FORWARD?
WILL IT BE SOMETHING DIFFERENT
IN ?
THERE'S THE BASE, WE DON'T LIKE
TO TOUCH THAT BECAUSE WE KNOW
WHAT COMES OUT OF THAT.
SO HOW IS THAT FRAMED?
IT'S PLANNING.
WE'RE A YEAR OR TWO AWAY, NOT
THAT FAR OUT.
IT'S ALREADY BEEN KICKED OFF
WITH A FEW PROGRAMS.
WE STILL DON'T KNOW HOW IT'S
GOING TO BE FORMATTED.
>> WELL, I THINK THAT'S A GOOD
POINT.
THERE ARE LOTS OF SUBMISSIONS.
PEOPLE ARE -- THERE WAS -- THEY
HAVE WHITE HOUSE STAFF THAT WILL
BEGIN TO PRIORITIZE.
I DON'T THINK IT WILL LOOK MUCH
LIKE THE LAST MOONSHOT.
I THINK IT IS MUCH, MUCH MORE
PATIENT FOCUSED AND DELIVERY OF
CARE FOCUSED, AND IMPROVING SOME
THINGS THAT WE'VE DISCUSSED
ACTUALLY AROUND ESPECIALLY
MINORITY AND UNDERSERVED
POPULATIONS, WHERE WE HAVE BIG
ISSUES.
SO, I THINK WE'RE GOING TO HAVE
TO WAIT AND SEE.
EVEN THE AMOUNT OF FUNDING THAT
WILL BE AVAILABLE, I DON'T THINK
WE YET KNOW.
>> RIGHT.
>> AND A LOT OF THIS IS GOING TO
DEPEND ON OBVIOUSLY ON THE
ELECTION BUT I AM GLAD TO SEE IT
CONTINUING AND I THINK WE SHOULD
ALL BE HAPPY ABOUT THAT PART.
THANKS TO THE COMMITTEE.
I GUESS THE BYPASS BUDGET
PLANNING GETS UNDERWAY SOON AT
NCI, SO WE'LL BRING THAT BACK TO
THE COMMITTEE ONCE IT'S DONE.
>> WE DO HAVE TIME FOR
ADDITIONAL QUESTION, AND I'LL
ASK A QUESTION.
I DON'T KNOW IF ANYONE CAN
ANSWER IT.
IT GOES BACK TO FREDERICK
NATIONAL LAB.
YOU KNOW, THINKING ABOUT THE OUT
YEARS, WHEN WILL THE CONTRACT BE
RECOMPETED AND HOW DOES THAT
SORT OF ROLL INTO FUTURE NCI
BUDGETS?
DOUG?
>> WELL --
>> THAT'S A DOUG QUESTION.
>> JOHN, THE RECOMPETE IS
SUPPOSED TO BE, YOU KNOW, MORE
OR LESS SEAMLESS.
IN OTHER WORDS, IT'S AN OPEN
COMPETITION.
THE CURRENT CONTRACTOR CAN APPLY
IF THEY WANT TO.
THEY CAN APPLY IN CONJUNCTION
WITH OTHER GROUPS IF THEY WANT
TO.
YOU KNOW, AND THERE WOULD BE
PRESUMABLY ONE OF TWO OUTCOMES.
THE CURRENT CONTRACTOR WOULD GET
THE NEW CONTRACT OR A DIFFERENT
GROUP WOULD GET THE NEW
CONTRACT.
AND THERE WOULD BE, IF YOU WILL,
A TRANSITION PERIOD.
BUT THE TRANSITION IS NOT A
WHOLESALE TURNOVER OF PERSONNEL.
THERE ARE WHAT ARE REFERRED TO
AS KEY PERSONNEL.
AND IT'S A LIMITED NUMBER.
IT'S FEWER THAN 10 THAT WOULD
TURN OVER.
BUT WHAT I'M TRYING TO SAY IS
THAT IT'S NOT AS THOUGH THE WORK
THAT WAS GOING ON WOULD STOP.
>> RIGHT.
I GUESS THE QUESTION IS THE
SCALE, RIGHT?
WILL THE FUNDING LEVELS, THE
SALE, BE THE SAME?
THESE ARE THE QUESTIONS I'M
GETTING AT.
>> I SEE.
I MEAN, WHAT HAPPENS IS THAT
BECAUSE THESE AWARDS ARE MADE
FOR A LONG TIME PERIOD, WE TEND
-- YOU KNOW, WE TEND TO HAVE A
MAXIMUM -- YOU KNOW, RELATIVELY
HIGH MAXIMUM DOLLAR AMOUNT.
AND THE -- IT DOESN'T MEAN THAT
WE GET TO THAT AMOUNT.
IT'S JUST THAT IT'S FAR EASIER
TO SAY IT CAN GO UP TO A CERTAIN
AMOUNT THAN IT IS TO SAY, YOU
KNOW, LET'S SAY IT COULD BE $200
MILLION, BUT TURNS OUT YOU WANT
THREE, THAT'S MUCH HARDER THAN
TO SAY IT COULD BE FOUR, BUT WE
ONLY NEED THREE.
>> GOT IT.
THANKS, DOUG.
AGAIN, TO ME IT FALLS WITHIN THE
CONTEXT OF BUDGET AND PLANNING.
THANK YOU, DOUG.
WE NEED TO VOTE, PAULETTE, IS
THAT CORRECT?
>> YES, YOU NEED TO VOTE ON EACH
REPORT INDIVIDUALLY.
>> OKAY.
GREAT.
SO, WE NEED TO -- IS THERE A
MOTION TO APPROVE --
>> NOT TO APPROVE, TO ACCEPT.
>> TO ACCEPT THE REPORT,
EXPERIMENTALITY SUBCOMMITTEE
REPORT.
>> ACCEPT.
>> IS THERE A SECOND?
>> SECOND.
>> IT'S BEEN PROPERLY MOVED AND
SECONDED.
WE CAN NOW VOTE.
ARE THERE ANY NAYS?
THERE'S A HAND UP.
OH, THANKS, AMY.
OKAY, GREAT.
ANYONE NEED TO --
>> I THOUGHT YOU WERE GOING
AFFIRMATIVE.
>> ANYONE NEED TO ABSTAIN?
OKAY.
SO, LOOKS LIKE WE HAVE A
UNANIMOUS VOTE TO ACCEPT THE
EXPERIMENTAL THERAPEUTICS
SUBCOMMITTEE REPORT.
>> OKAY.
AND THEN YOU NEED TO DO THE
PLANNING AND BUDGET.
>> SO, IS THERE A MOTION TO
ACCEPT THE PLANNING AND BUDGET
SUBCOMMITTEE REPORT?
IS THERE A MOTION?
>> YES, THERE'S A MOTION.
>> IS THERE A SECOND?
IT'S BEEN PROPERLY MOVED AND
SECONDED.
NOW WE CAN VOTE.
VOTE TO ACCEPT THE REPORT.
ARE THERE ANY NAYS?
ANY ABSTENTIONS?
SO LOOKS UNANIMOUS.
>> SO, NOW, JOHN, WE'LL MOVE
INTO FUTURE AGENDA ITEMS AND
OTHER AGENDA ITEMS.
WHEN HE MOVES INTO THIS
TERRITORY, THIS IS A GOOD TIME
FOR BOARD MEMBERS TO COME UP
WITH SUGGESTIONS, ET CETERA.
SO KAREN HAS HER HAND UP.
>> I SEE CHRIS AND KAREN.
LET'S START WITH CHRIS BECAUSE I
THINK HE HAD HIS HAND UP BEFORE.
>> OKAY.
>> THANKS SO MUCH.
THIS IS A FOLLOW-UP TO OUR
DISCUSSION WITH DR. BARKER'S
SUBCOMMITTEE.
OF THE BIG UNKNOWN OF ARPA-H, IF
YOU LOOK AT THE MINUTES FROM OUR
JUNE MEETING YOU'LL SEE I ASKED
THAT WE HAVE A REPRESENTATIVE
FROM ARPA-H PRESENT TO THIS
COMMITTEE.
IN OUR PLANNING FUNCTION, SO WE
CAN ADVISE THE NCI PROPERLY ON
FUTURE STRATEGY.
I'LL MAKE THAT REQUEST AGAIN.
NOW THAT DR. RUSSELL IS
APPOINTED, THAT DR. RUSSELL MEET
WITH US AT OUR NEXT SCHEDULED
MEETING.
>> THAT'S GREAT TIMING.
>> THANK YOU.
>> PERHAPS A PERMANENT DIRECTOR
IN PLACE AS WELL, GREAT TIMING.
OKAY, KAREN?
>> YES, JOHN, THANKS.
I WOULD LIKE TO MAKE A REQUEST
THAT WHEN THE CANCER CENTER
SUBCOMMITTEE PRESENTS THAT THEY
PROVIDE SOME DATA TO US AROUND
WHICH OF THE COMPREHENSIVE
CANCER CENTERS DO NOT ACCEPT
MEDICAID SO THAT MAYBE WE CAN
PROVIDE SOME STRATEGIES AROUND
WAYS TO RETHINK HOW WE ARE
THINKING ABOUT ACCESSING AND
SUPPORT AROUND RESEARCH AND
CLINICAL TRIAL ENGAGEMENT.
>> RETHINK.
OKAY, GREAT.
I'LL TAKE THE CHAIR'S
PREROGATIVE BEFORE MOVING TO
HOWARD, WHICH IS IT WOULD BE
GREAT TO SEE THE TRAJECTORY OF
THE NUMBER OF ESI SUBMISSIONS
AND ESI-FUNDED GRANTS OVER SOME
PERIOD.
PARTICULARLY AT LEAST ONE OR TWO
OF THE COVID YEARS.
JUST TO LOOK AT THE TRAJECTORY,
RIGHT?
OF ESI GRANT SUBMISSIONS AND
THOSE THAT ARE FUNDED, OVER
MAYBE FIVE OR TEN YEARS.
THAT WOULD BE I THINK REALLY
GREAT TO SEE.
HOWARD?
>> YEAH, THANK YOU.
I'D LIKE TO PROPOSE A TIMELY
PRESENTATION ABOUT THE CURRENT
STATUS AND PLANS OF
IMMUNO-ONCOLOGY BIOMARKERS.
I'M AWARE THAT SOME SENIOR STAFF
WORKING ON THIS AT NCI HAVE
ALREADY STARTED TO LEARN FROM
PAST MISTAKES AND PITFALLS WITH
BIOMARKERS, AND COULD PROBABLY
HELP US AVOID THE SAME GOING
FORWARD, IF WE, YOU KNOW, WE
DON'T WANT TO, YOU KNOW, LET
HISTORY REPEAT ITSELF.
WE'D RATHER LEARN FROM HISTORY I
THINK.
AND MOVE FORWARD.
AND I THINK IT WOULD BE TIMELY
AGAIN BECAUSE OF THIS TRAINING
WORK THAT'S GOING ON, AND WE ALL
I THINK AGREE, I HOPE WE AGREE,
THAT THE MAJOR INVESTMENTS BY
THE SIMACs AND MOONSHOT
PROGRAM, IMMUNO-ONCOLOGY
BIOMARKERS APPLICABLE TO
ENRICHMENT FOR CELL THERAPIES,
GENE THERAPIES, ET CETERA, ARE
THEY IMPORTANT.
WE WANT TO GET IT RIGHT.
AND ALSO MAYBE HELP INFLUENCE
GRANT APPLICATIONS GOING FORWARD
AND OUR EVALUATION OF GRANT
APPLICATIONS.
>> ABSOLUTELY.
IT'S A GREAT POINT.
SO, IMMUNOTHERAPEUTIC BIOMARKERS
AND WHAT'S HAPPENING INTERNALLY
AT THE NCI, AND SO IT'S GREAT.
THANKS, HOWARD.
FANTASTIC.
SO WE'RE RIGHT AT THE TOP OF THE
HOUR.
AND SO THIS WOULD CONCLUDE THE
OPEN SESSION OF THE NCAB
MEETING.
THERE WILL BE A 10-MINUTE BREAK,
ONLY BOARD MEMBERS AND
DESIGNATED NCI STAFF SHOULD
RETURN.
ALL SHOULD SIGN OFF THIS LINK
AND UTILIZE THE NEW WEB LINK FOR
THE CLOSED SESSION, WITHIN TEN
MINUTES.
THANK YOU ALL FOR ATTENDING
TODAY'S MEETING.