>>WELCOME
TO THE SUMMER NCRA MEETING AND I
TOLD MOST OF YOU INDIVIDUALLY
WHEN YOU JOINED, THANK YOU SO
MUCH FOR JOINING US VIRTUALLY
TODAY. WE KNOW YOU ARE BUSY.
AS ALWAYS, WE THANK YOU FOR
MAKING TIME AND KAFBING OUT
SPACE IN WHAT I KNOW ARE BUSY
DAYS AS ADVOCATES WHERE YOU ARE
JUGGLING MANY DIFFERENT THINGS
ON BEHALF OF PATIENTS.
WE APPRECIATE IT.
I THINK WE HAVE A TERRIFIC
MEETING PLANNED FOR US THIS
AFTERNOON. I WILL HAVEND IT TO
OUR TRUSTEE CHAIR, ANNIE,
MOMENTARILY. I WILL SHARE ABOUT
WHAT WE PLAN TO DO IN THE NEXT
COUPLE OF HOURS.
AS YOU ALL SAW WHEN YOU JOINED
IN PREMEETING MATERIALS, WE ARE
JOINED THIS AFTERNOON BY
PRINCIPLE DEPUTY DIRECTOR DOUG
LOWY THAT MOST KNOW AND WORKED
WITH IN THE PAST AND LE JOIN
GIVING A DIRECTOR'S UPDATE THAT
HIGHLIGHTS ACROSS OUR RESEARCH
PORTFOLIO AND PLENTY OF TIME FOR
QUESTION AND ANSWER DISCUSSION
AFTERWARDS.
AFTER DR. LOWY, WE WILL BE
JOINED BY DR. MEREDITH SHIELDS A
SENIOR NCI INVESTIGATOR THAT
WILL TALK ABOUT A RECENT STUDY
SHE CREATED THAT RELATES TO
OUTLINING OPPORTUNITIES TO
ACHIEVE SOME MOONSHOT GOALS AND
SOME MAY REMEMBER THIS WAS
HIGHLIGHTED AT AACR AND WE SENT
BACK TO YOU IN APRIL AND CHANCE
TO HEAR FROM YOU THE
INVESTIGATOR AND TALK A LITTLE
TOGETHER WITH HER AND EACH OTHER
ABOUT WHAT IS COVERED IN THAT
STUDY.
AND FOLLOWING THAT THIS
AFTERNOON WE WILL TALK ABOUT THE
RECENTLY ANNOUNCED CLINICAL
TRIALS INNOVATION UNIT. I
TALKED TO SOME INDIVIDUALLY
ABOUT THAT. THIS IS AN
INTERESTING PROGRAM AND REAL
SWEET SPOT FOR ADVOCACY
CONSIDERING IT IS SORT OF ON THE
CLINICAL END OF OUR CONTINUUM
AND CLINICAL TRIALS AND SHOULD
BE A NICE DISCUSSION AS WELL AND
WE WILL ALWAYS CONCLUDE WITH
LEDGE UPDATE AND DOUG WILL TALK
A LITTLE ABOUT BUDGET IN HIS
UPDATE. WE WILL BE JOINED BY
LEGISLATIVE AND GOVERNMENT
AFFAIRS OFFICE FOR ALL
ENCOMPASSING UPDATE WITH THE
MEETING AND WITH THAT MANY
THANKS FOR YOUR TIME TODAY AND
FOR JOINING US.
I WILL TURN IT OVER TO ANNIE TO
GET US UNDERWAY.
>>THANK YOU SO MUCH, ANNIE.
THANK YOU, EVERYONE, FOR BEING
HERE. I WILL OFFICIAL WILL I
CALL THE MEETING TO ORDER AND TO
BEGIN I HAVE TO READ THE OPENING
STATEMENT. AS COMMITTEE
MEMBERS, I MUST REMIND YOU TO
ABSENT YOURSELVES DURING
SPECIFIC DISCUSSIONS.
WHENEVER YOUR PARTICIPATION AND
DELIBERATIONS ON A PARTICULAR
PRODUCT, PROGRAM OR OTHER
SPECIFIC MATTER WOULD CONSTITUTE
A CONFLICT OF INTEREST OR CREATE
APPEARANCE OF ONE.
IT IS ENCOMBANT UPON YOU TO
ADVISE THE EXECUTIVE SECRETARY
AND ABSTAIN FROM PARTICIPATION
AND DISCUSSION OF ACTION
REGARDING THAT MATTER AND IN
LIGHT OF CURRENT POLICIES
GOVERNING -- HOLDINGS OF SPECIAL
GOVERNMENT EMPLOYEES THAT
INCLUDE ALL MEMBERS OF THIS
COMMITTEE WE MUST DEPEND ON YOU
TO VOLUNTARILY ABSENT YOURSELF
DURING ANY AND ALL DISCUSSIONS
AND MATTERS TO CONCEIVABLY
IMPACT STATUS OF HOLDINGS AND
TRUST YOUR JUDGMENTS IN
INSTANCES AND BY LAW A QUORUM OF
BOARD MEMBERS IS ACQUIRED FOR
INSTANCE THAT OPEN VOTE OCCURS
IN OPEN SESSION AND MINIMUM OF 8
APPOINTED MEMBERS MUST BE
PRESENT TO VOICE THEIR VOTES.
ARE WE THERE, AMY?
EXCELLENT. NEW MEMBERS NOT
CURRENT MEMBERS OF ANOTHER NCI
ADVISORY BOARD ARE NOT VOTING
UNTIL THEY ARE CLEARED BY ETHICS
OFFICE AND OFFICE OF HUMAN
RESOURCES AND I WILL READ THE
PUBLIC COMMENT STACHLT. MEMBERS
OF THE PUBLIC WISHING TO EXPRESS
VIEWS REGARDING ANY ITEMS
DISCUSSED DURING THIS MEETING
MAY DO SO WRITING AMY WILLIAMS
EXECUTIVE SECRETARY WITHIN 10
DAYS OF THE MEETING AND WRITTEN
STATEMENTS BY MEMBERS OF THE
PUBLIC WILL RECEIVE CAREFUL
CONSIDERATION.
I AM REALLY THRILLED, AGAIN,
THAT WE ARE TOGETHER AGAIN.
ESPECIALLY AFTER GETTING TO KNOW
EVERYONE A LITTLE BIT A LITTLE
MORE AT THE LAST MEETING.
WE WILL GO AHEAD AND PROCEED
WITH THE PRINCIPLE DEPUTY
DIRECTOR'S UPDATE. AT THIS TIME
I WOULD LIKE TO WELCOME DOUG
LOWY NCI'S PRINCIPLE DEPUTY
DIRECTOR TO DELIVER HIS UPDATE
AND AS YOU KNOW HE IS PRINCIPLE
DEPUTY DIRECTOR SINCE JULY 2010
AND HELPING TO LEAD KEY
SCIENTIFIC INITIATIVES AND
ACTING DIRECTOR SEVERAL TIMES
RECENTLY IN APRIL 2022 TO
SEPTEMBER OF 2022 IN ADDITION TO
SERVING AS NCI PERFECT INSIM
DEPUTY DIRECTOR, HE IS CHIEF OF
LABORATORY OF CELLULAR ONCOLOGY
AND NCI CENTER FOR CANCER
RESEARCH AND MEMBER OF NATIONAL
ACADEMY OF SCIENCES AND
INSTITUTE OF MEDICINE OF NAS.
SO, DR. LOWY, THA THANKS SO MUC
FOR BEING WITH US AND PROVIDING
THIS UPDATE.
>>EVEN, IT IS A REAL PLEASURE
TO BE HERE AND I'M LOOKING
FORWARD TO TALKING FOR AROUND A
HALF HOUR OR SO AND THEN TO BE
ABLE TO RESPOND TO COMMENTS AND
QUESTIONS WHERE I THINK WE WILL
HAVE A FAIR AMOUNT OF TIME.
AND AS AMY HAS POINTED OUT,
THERE IS REALLY A LOT OF GOOD
TOPICS THAT WILL BE COVERED
TODAY.
FIRST, IF I COULD HAVE THE NEXT
SLIDE.
I AM TALKING ABOUT A NUMBER OF
DIFFERENT ISSUES THIS AFTERNOON.
FIRST, I WANT TO GO OVER THE
DEBT CEILING AGREEMENT AND NOT
SURE THAT PEOPLE UNDERSTAND IT
ACTUALLY HAS LIKELY IMPORTANT
IMPLICATIONS FOR NCI BUDGET.
THEN ALSO TO TALK ABOUT THE
CANCER DRUG SHORTAGES THAT HAVE
BEEN IN THE NEWS RECORRECTLY AND
TALK ABOUT RESEARCH INITIATIVES
AND RESEARCH ADVANCES AND THEN A
LAST TOPIC THAT IS RELATED TO
CANCER POLICY.
SO, IF I COULD HAVE THE NEXT
SLIDE.
THIS SLIDE SUMMARIZES SOME OF
THE SALIENT FEATURES OF THE DEBT
CEILING AGREEMENT THAT WAS MADE
EARLIER THIS MONTH.
AND ON THE ONE HAPPENED, THE
FIRST BULLET POINT TELLS YOU
THAT THE GOAL WAS TO RAISE THE
DEBT LIMIT THROUGH 2025.
BUT, IT ALSO IMPOSES CAPS ON
GOVERNMENT SPENDING FOR THE NEXT
TWO FISCAL YEARS THAT IS FOR
FY24 AND FOR FY25.
AND THE AGREEMENT AS SHOWN IN
THE THIRD BULLET POINT IS
FUNDING LEVEL 24 IS HELD AT FY23
LEVELS FOR NEXT FISCAL YEAR FOR
NONDEFENSE DISCRETIONARY
SPENDING THAT IS WHERE THE NIH
AND NCI BUDGET FALL.
THE LAST BULLET POINT WILL
LIKELY EFFECT FUNDING FOR MANY
GOVERNMENT AGENCIES INCLUDING
AND INCLUDING NIH.
NEXT SLIDE.
THIS SLIDE DEPICTS FOR YOU WHAT
HAS HAPPENED OVER THE LAST 20
YEARS TO THE NCI BUDGET STARTING
IN 2023 AND ENDING WITH 2023.
IF YOU LOOK AT THE RED LINE,
WHAT I HOPE YOU CAN APPRECIATE
IS THAT DURING THE FIRST 10
YEARS, BETWEEN 2003 AND 2013,
THE NCI BUDGET IN 2003 DOLLARS
THAT IS REALLY WHAT IS THE
PURCHASING POWER OF THE NCI
BUDGET THAT IT WENT DOWN
SUBSTANTIALLY OVER THAT 10 YEAR
PERIOD.
STARTING AROUND 2015 AS MOST OF
YOU ARE AWARE, NIH, INCLUDING
NCI HAVE RECEIVED ANNUAL
INCREASES TO THE BUDGET.
THIS HAS RESULTED, AS SHOWN IN
THE RED, THAT THE PURCHASING
POWER HAS GONE UP SOMEWHAT.
IF YOU LOOK AT THE RED LINE FROM
2003 COMPARED TO 2023, THE
PURCHASING POWER OF THE CURRENT
NCI BUDGET IS ABOUT 87% OF WHAT
IT WAS IN 2003.
SO, THAT WE ACTUALLY DESPITE THE
GENEROSITY OF CONGRESS OVER THE
LAST FEW YEARS, OUR PURCHASING
POWER FOR RESEARCH IN 2023 IS
ACTUALLY SOMEWHAT LOWER THAN IT
WAS IN 2003, 20 YEARS EARLIER.
THE NEXT SLIDE THEN TELLS YOU
ABOUT THE PRESIDENT'S BUDGET
PROPOSAL FOR NCI FOR FISCAL YEAR
'24.
AND BASICALLY, WHAT IT IS
PROPOSING, DEPENDING ON HOW YOU
CALCULATE THINGS IS EITHER A
$500 MILLION INCREASE OR A $700
MILLION INCREASE.
THE REASON THERE IS A LITTLE BIT
OF AMBIGUITY IS THAT THE NCI, IN
ADDITION TO THE BASE BUDGET, OF
$7 BILLION FOR FY23 HAS AN
ADDITIONAL $216 MILLION FOR
PHASE 1 OF THE CANCER MOONSHOT.
SO, THAT ASPECT, THAT 216 IS
PROPOSED TO BE ADDED TO THE NCI
BUDGET FOR FY24.
ON TOP OF THAT, ANOTHER $500
MILLION FOR THE CANCER MOONSHOT,
THE REIGNITED ONE, 2.0.
SO, THERE IS A TOTAL OF 716
MILLION.
IF YOU LOOK DOWN AT THE BOTTOM,
YOU WILL SEE THAT WHAT HAS
HAPPENED IN ADDITION IS AN
UNUSUAL SITUATION WHERE THE
BIDEN ADMINISTRATION HAS IN
ADDITION TO THIS PROPOSAL FOR
FY24 MADE AN ADDITIONAL INCREASE
PROPOSED FOR FY25 AND 26 OF JUST
UNDER $1.5 BILLION FOR NCI.
AND I'M GOING OVER THIS BECAUSE
REALLY THIS IS, I THINK, GOING
TO BE PLACED IN JEOPARDY BECAUSE
OF THE -- THE DEBT CEILING
AGREEMENT.
LET'S GO TO THE NEXT TWO SLIDES
AND TALK ABOUT SOME OF THE
HEALTH ASPECTS THAT ARE PROPOSED
FOR THE NEW PHASE OF THE CANCER
MOONSHOT.
ONE IS TO REDUCE CANCER DEATH
RATE BY AT LEAST 50% OVER THE
NEXT 25 YEARS.
TWO TO OVERCOME CANCER
DISPARITIES AND 3, END CANCER AS
WE KNOW IT.
THESE ARE VERY AMBITIOUS AND
ASPIRATIONAL GOALS OF THE BIDEN
ADMINISTRATION.
ALTHOUGH THEY ARE THE GOALS OF
THE BIDEN ADMINISTRATION, I
THINK OF THEM AS BEING
NONPARTISAN. IT IS REALLY
TRYING TO HELP EVERYONE IN THE
US TO LIVE LONGER, HAPPIER AND
MORE FRUITFUL LIVES AS A RESULT
OF IMPROVEMENT BECAUSE OF CANCER
RESEARCH AND ITS APPLICATION.
THE NEXT SLIDE IS BASICALLY
TELLING YOU ABOUT WHERE WE ARE
TODAY VERSUS WHERE WE WOULD NEED
TO GO IN ORDER TO ACHIEVE THAT
GOAL OF REDUCING CANCER
MORTALITY OVER THE NEXT 25 YEARS
BY AT LEAST 50%.
AND THIS IS A PEER-REVIEWED
PUBLICATION THAT WAS PUBLISHED
IN APRIL.
YOU ARE GOING TO BE PRIVILEGED
TO HEAR MEREDITH SHIELS AFTER MY
PRESENTATION.
SHE IS THE PRINCIPLE AUTHOR OF
THIS PEER REVIEW PUBLICATION
WHOSE BOTTOM LINE CONCLUSION IS
THAT WE ARE PART WAY THERE, BUT
WE NEED TO HAVE MORE RESEARCH IN
ORDER TO GET ALL THE WAY TO THE
50% REDUCTION. DR. SHIELS IS A
WORLD EXPERT ON POPULATION
DYNAMICS AND POPULATION CANCER
INCIDENTS AND CANCER MORTALITY
AND INDEED INCIDENTS AND
MORTALITY FROM OTHER DISEASES.
SO, FOR EXAMPLE, SHE PUBLISHED
SEVERAL NOTEWORTHY ARTICLES
DURING THE SARS-COV-2 EPIDEMIC
FROM EXCESS OF COV2 AS WELL AS
OTHER DISEASES.
TODAY, SHE WILL BE FOCUSED ON
THIS CANCER PART.
BECAUSE OF THE DEBT CEILING
AGREEMENT AND REALLY INCREDIBLE
PROPOSAL ON PART OF THE BIDEN
ADMINISTRATION FOR INCREASES TO
THE CANCER -- TO THE NCI BUDGET
OVER THE NEXT FEW YEARS, THOSE
INCREASES WILL PROBABLY BE IN
JEOPARDY EITHER IN WHOLE OR IN
FULL BECAUSE OF THE DEBT CEILING
AGREEMENT. THIS WASN'T AN
INTENDED CONSEQUENCE OF THE DEBT
CEILING AGREEMENT BUT COULD BE
AN UNINTENDED CONSEQUENCE.
ENOUGH ABOUT THE BUDGET
SITUATION.
LET'S GO ON TO ANOTHER ISSUE,
WHICH IS THE DRUG SHORTAGE
ISSUE.
AND I HAVE BASICALLY MADE THE
HEADLINE ACTUALLY FROM THE
HEADLINE FROM AN ARTICLE THAT
WAS PUBLISHED YESTERDAY IN THE
WASHINGTON POST OF ABOUT THE
CANCER DRUG SHORTAGES.
AND THIS IS SOMETHING THAT HAS
BEEN AN INTERMITTENT AND
REOCCURRING PROBLEM.
RIGHT NOW IS REALLY HAVING A
MAJOR NEGATIVE IMPACT BOTH WITH
CANCER RESEARCH IN TERMS OF
CLINICAL TRIALS AND DRUG
AVAILABILITY AS WELL AS FOR
PATIENTS, ESPECIALLY PEDIATRIC
PATIENTS FOR WHOM SOME OF THESE
BEST TREATMENTS DON'T HAVE VERY
GOOD ALTERNATIVES.
THIS LISTS FOR YOU A NUMBER OF
THE DRUGS THAT CURRENTLY ARE IN
VERY SHORT SUPPLY.
THE CONGRESS, THE WHITE HOUSE,
AND THE FD ACA ARE DOING A LOT
THINGS TO TRY TO SUCCESSFULLY
ADDRESS THIS PROBLEM BUT AT ITS
FUNDAMENTAL CORE, THE
MANUFACTURERS WHO MAKE THESE
DRUGS THAT ARE GENERIC, THEIR
FEELING IS THAT THEY ARE NOT
ABLE TO GET ENOUGH PROFIT FROM
SELLING THE DRUGS SO THESE ARE
DRUGS THAT THEY STOPPED
MANUFACTURING.
MANY OF THE DRUGS HAVE VERY
LIMITED NUMBERS OF
MANUFACTURERS.
SO, HOPEFULLY THERE WILL BE A
SUCCESSFUL CONCLUSION TO
OVERCOMING THIS PROBLEM. THIS
IS A LONG-TERM ISSUE THAT
CLEARLY NEEDS TO BE ADDRESSED.
THE NEXT SLIDE SHOWS YOU JUST
WHAT HAPPENS WITH OUR CURRENT
TRIALS WITH THE ONCOLOGY AGENTS
CURRENTLY IN SHORT SUPPLY.
THE TRIALS GENERALLY ARE LOOKING
AT NEW AGENTS.
BUT, FREQUENTLY, THE NEW AGENTS
ARE EITHER BEING ADDED TO
ESTABLISHED AGENTS OR THE
CONTROL GROUP IN THE TRIAL IS
GETTING THE BEST IN CLASS
CURRENT STANDARD OF CARE
TREATMENT.
WHAT I HOPE YOU CAN SEE IS THAT
THERE ARE A LOT OF TRIALS WHOSE
ACCRUAL IS BEING A SERIOUSLY
EFFECTED BY THE -- BY THE DRUG
SHORTAGE.
IN THE NEXT SLIDE, THEN, YOU
KNOW, SUMMARIZES FOR YOU SOME OF
TH
THIS.
JUST KEEP IN MIND THAT AROUND 5%
OF CANCER PATIENTS GO ON TO DRUG
TRI
TRIALS.
THEREFORE, THERE IS A MUCH
BIGGER PROBLEM FOR PEOPLE TRYING
TO RECEIVE STANDARD OF CARE WHO
ARE NOT IN TRIALS AND FOR WHOM
THESE DRUG SHORTAGES ARE REALLY
DIRE.
SO, IT IS REALLY IMPORTANT THAT
WE ARE WORKING WITH THE WHITE
HOUSE, WITH THE FDA TO TRY TO
HELP TO SUCCESSFULLY ADDRESS
THESE SHORTAGES.
SO, NOW, I WANT TO GO ON AND
TALK ABOUT SOME OF THE NEW
INITIATIVES.
AND YOU ARE GOING TO BE HEARING
FROM DR. PRINDIVILLE ABOUT THE
CLINICAL TRIALS INNOVATION UNIT.
I WANT TO JUST GIVE YOU A
PREVIEW THAT ITS GOAL IS TO
BUILD BETTER, FASTER, MORE
ACCESSIBLE CANCER CLINICAL
TRIALS.
IT IS NOT GOING TO BE FOR ALL OF
THE TRIALS THAT WE DO, BUT TO
SELECT A FEW HIGH PRIORITY
STUDIES AND TO SPEED CLINICAL
TESTING TO DELIVER NEW
APPROACHES.
REALLY, LOOKING FOR INPUT FROM
ALL STAKEHOLDERS AND AS I SAY,
DR. PRINDIVILLE WILL TALK ABOUT
THIS IN FAR MORE DETAIL.
NEXT SLIDE.
AND THIS SLIDE IS TALKING ABOUT
A NEW CLINICAL TRIAL THAT IS --
THAT -- THAT IS ABOUT TO START
THAT HAS JUST STARTED THAT IS
CALLED COMBO MATCH. MANY OF YOU
WILL REMEMBER THE MATCH TRIAL
THAT WAS STARTED BACK IN 2016
WITH THE FIRST CANCER MOONSHOT.
IT WAS A TRIAL THAT WAS THE
FASTEST ACCRUING TRIAL THAT NCI
HAS EVER HAD.
INSTEAD OF THE TRIAL BEING
FOCUSED ON A SPECIFIC KIND OF
CANCER, THE TRIAL WAS FOCUSED ON
MOLECULAR ABNORMALITIES AND
PEOPLE WITH SPECIFIC MOLECULAR
ABNORMALITIES INDEPENDENT OF THE
KIND OF CANCER THAT THEY HAD
WERE THEN ELIGIBLE FOR TREATMENT
WITH EITHER EXPERIMENTAL DRUGS
OR FDA APPROVED DRUGS BUT FOR
APPROVED INDICATIONS OTHER THAN
WHAT THE PATIENT ACTUALLY HAD.
THE MATCH TRIAL LED TO SEVERAL
FDA APPROVALS FOR A SUBSET OF
THE DRUGS THAT WERE BEING TESTED
IN WHAT ENDED UP BEING A
MULTI-ARM TRIAL MORE THAN 30
ARMS IN THIS KIND OF TRIAL THAT
IS REALLY IMPORTANT TO THINK
ABOUT THE NUMBER ARMS.
IT IS DIFFICULT FOR ANY ENTITY
OTHER THAN NCI TO SPONLSOR THIS
KIND OF TRIAL.
THE INITIAL ARMS ARE GOING TO BE
-- WILL BE 6 FOR COMBO MATCH.
IT IS BASICALLY TESTING
COMBINATIONS THAT ARE NOT YET
FDA APPROVED BUT FOR WHICH THERE
ARE REALLY STRONG INDICATIONS
THAT THEY MIGHT WORK WELL
TOGETHER.
THE PROBLEM THAT THIS IS
DESIGNED TO ADDRESS AND OVERCOME
IS THAT THERE ARE MANY AREAS
WHERE THERE ARE SINGLE AGENTS
THAT GIVE GOOD SPONLSS, BUT THE
GOOD RESPONSES TEND TO LAST FOR
A FINITE TIME PERIOD.
SO, COMBINATION TREATMENTS ARE A
VERY IMPORTANT APPROACH TO TRY
TO MAKE IT POSSIBLE FOR PEOPLE
TO HAVE RESPONSES THAT WILL BE
FAR MORE DURABLE OR LONG LASTING
THAN THEY WOULD HAVE FROM SINGLE
AGES.
NEXT SLIDE.
THIS IS A NEW AREA THAT HAS
BECOME VERY IMPORTANT FOR NCI AS
IT HAS BECOME SO IMPORTANT FOR
CANCER, CANCER ISSUES NATIO
NATIONALLY.
WE PUBLISHED A PAPER THREE YEARS
AGO THAT EMPHASIZED HOW
IMPORTANT SOCIAL DETERMINANTS OF
CANCER ARE BECOMING FOR CANCER
OUTC
OUTCOMES AND THAT THE AREAS OF
THE COUNTRY WITH THE MOST -- THE
MOST PERSISTENT POVERTY ALSO HAD
MUCH HIGHER INCIDENTS AND POORER
OUTCOMES OF CANCER.
SO, THIS IS TO TRY TO ADDRESS
THIS WITH A NEW PERSISTENT
POVERTY INITIATIVE.
THIS IS ONE OF WHAT I THINK WILL
BE OTHER AREAS WHERE IT -- IT IS
REALLY GOING TO BE SOCIOECONOMIC
STATUS OR SOCIO DETERMINANTS OF
HEALTH THAT ARE HAVING MORE AND
MORE OF AN IMPACT ON CANCER
HEALTH INCLUDING CANCER OUTCOMES
AND TRYING TO BE MORE EQUITABLE
AND OVERCOME THESE GAPS OF --
AND DISPARITIES THAT WILL BE
MORE AND MORE LOOKING TOWARDS
POVERTY IN ADDITION TO RACIAL
AND ETHNIC ISSUES.
NEXT SLIDE.
THIS IS TO HIGHLIGHT A FEW
ADVANCES THAT I WILL GO OVER
THEM RELATIVELY QUICKLY.
THESE SLIDES ARE AVAILABLE TO
YOU. YOU CAN GO TO THE ACTUAL
STUDIES THEMSELVES FOR THEM.
MEG MOONY WHO HEADS UP CANCER
THERAPY AND EVALUATION PROGRAM
CTEP PRESENTED SOME OF THE
RESULTS LAST WEEK AT JOINT
NATIONAL CANCER BOARD AND
SCIENTIFIC ADVISORY BOARD
MEETING AND THOUGHT THEY REALLY
REFLECTED SOME ADVANCES THAT
HAVE BEEN MADE POSSIBLE THROUGH
CLINICAL TRIALS RESEARCH
SUPPORTED BY NCI.
NEXT SLIDE.
SO, THE FIRST WAS REALLY A
RANDOMIZED STUDY FOR NEWLY
DIAGNOSED ADVANCED STAGE HOJ
KINES DISEASE IN RELATIVELY
YOUNG ADULTS.
AND IT WAS ESSENTIALLY ADD IING-
I'M SORRY ADDING NOVOLOMAB TO
CURRENT STANDARD OF CARE THAT IS
MULTIDRUG CHEMOTHERAPY.
THIS RESULTS IN IMPROVED
REGRESSION FREE SURVIVAL
COMPARED TO THE CURRENT
TREATMENT.
SO, THE TREATMENT WAS WELL
TOLERATED AND VERY FEW RELATED
ADVERSE EVENTS THAT REALLY IS A
KEY STEP TOWARDS HARMONIZING
PEDIATRIC AND ADULT THERAPY FOR
ADVANCED HOJ KINES DISEASE AND
IS POISED TO BECOME NEW STANDARD
OF CARE TREATMENT FOR ADVANCED
STAGE HODGE KINES DISEASE.
NEXT SLIDE.
THIS WAS FOR WHETHER RECTAL
CANCER PASH YEVENTS COULD
RECEIVE CURATIVE INTENTIONAL
TREATMENT WITHOUT PELVIC
CHEMORADIATION THAT IS WHAT IS
CALLED A NON-INFERIORITY STUDY.
BASICALLY, IT MET ITS ENDPOINT
SUGGESTING THAT THIS CURATIVE
INTENT TREATMENT CAN BE DONE
WITHOUT PELVIC CHEMORADIATION.
AGAIN, MAY BECOME STANDARD OF
CARE IN THE NOT TOO DISTANT
FUTURE.
NEXT SLIDE.
THIS SUMMARIZES ANALOGOUS
ADVANCES, ONE FOR HIGH-RISK
CLASSICAL HODGE KINES LYMPHOMA
THAT IS NOT AS FAR ADVANCED WITH
THE ORIGINAL TRIAL THAT I
MENTIONED.
ANOTHER ADVANCE FOR ACUTE LYMPHO
BLASTIC LEUKEMIA IN ADULTS AND
THEN ANOTHER ADVANCE FOR
RECURRENT ENDOMETRIAL CANCER.
NEXT SLIDE.
SO, THIS SLIDE DISCUSSES A NEWLY
PUBLISHED PAPER ABOUT THE
CHILDHOOD CANCER DATA
INITIATIVE.
THIS IS A 10-YEAR 50 MILLION
DOLLAR A YEAR INFUSION OF FUNDS
FOR NCI THAT STARTED A LITTLE
OVER THREE YEARS AGO.
THIS PAPER THAT WAS PUBLISHED
REALLY EXPLAINS THE
ACCOMPLISHMENTS TO DATE OF THE
CLINICAL OR CHILDHOOD CANCER
DATA INITIATIVE DISCUSSING
PRIORITIES FOR THE FUTURE OF THE
INITIATIVE.
I URGE YOU TO GO AND LOOK AT THE
STUDY ITSELF.
THIS IS REALLY ONE CRITICALLY
IMPORTANT PART OF THE
MULTI-FACETED APPROACH THAT WE
ARE TAKING TO TRY TO IMPROVE THE
OUTLOOK FOR CHILDREN WHO DEVELOP
CANCER.
NEXT SLIDE.
SO, YOU ARE ALL AWARE OF THE
SARS-COV2 VACCINES WHOSE RAPID
DEVELOPMENT WAS ENABLED BECAUSE
OF RNA TECHNOLOGY THAT HAD BEEN
STRONGLY SUPPORTED BY THE NIH
OVER A NUMBER OF YEARS THAT WAS
POISED FOR THAT RAPID
DEVELOPMENT.
SARS-COV2 VAX AUTO EN --
VACCINE HAVE WORKED VERY WELL
BUT DURATION HAS WANED
RELATIVELY RAPIDLY AND THEY HAVE
ALSO HAD TO DEAL WITH THE
DEVELOPMENT OF VARIANCE. THIS
IS A REQUEST FOR INFORMATION FOR
TRYING TO USE RNA'S -- RNA-BASED
CANCER VACCINES FOR CANCER
TREATMENT PRIMARILY RATHER THAN
FOR PREVENTION.
RNA-BASED VACCINES MIGHT
ACTUALLY BE EVEN BETTER FOR
CANCER TREATMENT THAN THEY HAVE
BEEN FOR CANCER PREVENTION.
CANCER PREVENTION IS BEING GIVEN
VACCINES TO PEOPLE THAT ARE
OTHERWISE NORMAL AND HAS BEEN A
REAL FALL OFF IN UPTAKE OF
VACCINES AS TIME HAS GONE ON.
ON THE OTHER HAND, WHEN COMING
TO CANCER THERAPEUTIC VACCINES,
THESE ARE PEOPLE WHO HAVE CANCER
AND BY AND LARGE ARE HIGHLY
MOTIVATED TO TRY TO TAKE
ADVANTAGE OF ADVANCES IN
TREATMENT AND BEING -- IF THERE
IS A NECESSITY TO TAKE THESE
VACCINES MORE THAN ONCE OR
TWICE, THEY WILL BE HIGHLY
MOTIVATED.
OF COURSE, THIS IS ALL
THEORETICAL AT THE MOMENT AND
ARE NOT RNA-BASED VACCINES AND
CONSIDERABLE POTENTIAL FOR
FUTURE DEVELOPMENT AND THEREFORE
HAVE THIS REQUEST FOR
INFORMATION FOR THEM.
NEXT SLIDE.
SO, I NOW WANT TO GET TO THE
LAST TOPIC OF MY PRESENTATION,
WHICH REALLY HAS TO DO WITH
ANOTHER ADVANCE.
THIS IS A PHASE 3 TRIAL THAT WAS
PUBLISHED EARLIER THIS MONTH AND
IN THE NEW ENGLAND JOURNAL OF
MEDICINE THAT WAS BASICALLY
TAKING AN APPROACH THAT HAS
BECOME STANDARD OF CARE FOR
ADVANCED LUNG CANCER AND ASKING
WILL IT BE USEFUL FOR PATIENTS
WHO HAVE LESS ADVANCED LUNG
CANCER THAT IS FOCUSED ON WHAT
ARE CALLED NON-SMALL CELL LUNG
CANCER, WHICH REPRESENTS ABOUT
3/4 TO 80% OF LUNG CANCER TODAY.
SO, PATIENTS IN THIS CLINICAL
TRIAL WERE -- WHEN THEY HAD
EARLIER STAGE LUNG CANCER
DIAGNOSED, THEY WERE TESTED FOR
WHETHER OR NOT THEY HAD
MUTATIONS FOR EGF RECEPTOR THAT
AS I SAY ARE EGF RECEPTOR
INHIBITORS THAT ARE APPROVED FOR
TREATMENT IN ADVANCED NON-SMALL
CELL LUNG CANCER THAT IS LOOKING
AT EARLIER.
PATIENTS WERE RANDOMIZED ONCE
THOSE WHO HAD MOLECULAR
ABNORMALITY EITHER TO RECEIVING
INHIBITOR FOR EGF RECEPTOR OR
PLACEBO. WHAT I HOPE YOU CAN
APPRECIATE FROM KAPLAN-MEYER
CURVE IS A TREMENDOUS MORTALITY
BENEFIT FOR PATIENTS THAT
RECEIVE EGF RECEPTOR INHIBITOR
THIS IS NOT YET STANDARD OF CARE
BUT AS WITH OTHER RESULTS I
MENTIONED EARLIER IS LIKELY TO
BECOME STANDARD OF CARE IN THE
NOT TOO DISTANT FUTURE THAT THIS
LEADS TO MY LAST POINT.
NEXT SLIDE.
WHICH HAS TO DO WITH THE
POSSIBLE ROLE OF NCI TO
INCREASING ACCESS TO CANCER CARE
AND CONTROL ONE OF THE IMPORTANT
GOALS OF CANCER MOONSHOT.
NCI IS ABOUT CANCER RESEARCH WE
DON'T SET HEALTH CARE DELIVERY
POLICY BUT ARE TALKING AMONGST
OURSELVES WHETHER IT MIGHT BE
FRUITFUL FOR US TO WORK WITH
OTHER GROUPS TO ACHIEVE WIDER
AND MORE EQUITABLE DISSEMINATION
AND ACCESS TO CARE DELIVERY THAT
IS AN IMPORTANT GOAL OF THE
CANCER MOONSHOT.
AND IN CONTEXT WHAT I SHOWED YOU
IN THE PREVIOUS SLIDE ONE
POSSIBLE EXAMPLE OF ACCESS TO
UPTAKE OF TUMOR SEEK WENCY WHERE
SEEK WENCY IS RECOMMENDED BY
GUIDELINES.
IT TURNS OUT THAT THERE ARE SOME
IMPEDIMENTS TO PATIENTS GETTING
TUMOR DNA SEQUENCE.
AND THESE ARE LARGELY BASED ON
SOCIAL DETERMINANTS OF HEALTH IN
TERMS WHETHER THEY GET
SEQUENCED.
WE ARE THINKING ABOUT AS PART OF
FURTHERING GOALS OF CANCER
MOONSHOT POTENTIALLY WORKING
WITH OTHER GROUPS, THE CANCER
CENTERS AND AMERICAN CANCER
SOCIETY AND OTHER STAKEHOLDERS
TO TRY TO MAKE IT EASIER FOR ALL
PATIENTS TO HAVE WHEN IT IS
APPROPRIATE TO HAVE ACCESS TO AN
UPTAKE OF TUMOR DNA SEQUENCING
THAT IS A SPECIFIC EXAMPLE OF
WHAT WE MIGHT CONSIDER HAVING
SOME INVOLVEMENT WITH CONVENERS
MORE THAN ANYTHING ELSE.
I HAVE GONE THROUGH A NUMBER OF
DIFFERENT ISSUES THIS AFTERNOON
TALKING A BIT ABOUT BUDGET AND
CANCER AND DRUG SHORTAGES AND
RESEARCH INITIATIVES AND
RESEARCH ADVANCES AND THIS LAST
TOPIC LOOKING FORWARD TO YOUR
COMMENTS AND QUESTIONS AND
THANKS VERY MUCH FOR YOUR
ATTENT
ATTENTION.
>>WELL, DR. LOWY, THAT WAS A
LOT. A LOT OF EXCITING -- THERE
IS SO MUCH HAPPENING.
WHAT IS JUMPING OUT TO ME RIGHT
NOW IS, YOU KNOW, I WILL TALK
ABOUT PERSISTENT POVERTY THAT
YOU KNOW HAUNTS ME. I'M VERY
EXCITED ABOUT THAT PERSISTENT
POVERTY INITIATIVE BRINGING IT
TO THE FOREFRONT.
I THINK [INDISCERNIBLE] FOR
WORKING ON THAT.
>>YES. JUST SO YOU KNOW --
AMY, LET ME JUST SAY TWO THINGS.
OKAY?
>>OKAY.
>>FIRST, RURAL AREAS ARE AREAS
THAT IF YOU WILL PREFERENTIALLY
HAVE PERSISTENT POVERTY.
20 YEARS AGO THERE WAS NO
DIFFERENCE IN CANCER OUTCOMES
AND MORTALITY RATES FOR PEOPLE
IN RURAL AREAS VERSUS URBAN
AREAS.
IT WAS RECOGNIZED BACK IN 2015
THAT LARGELY BECAUSE OF ADVANCES
IN CANCER TREATMENT AND CANCER
SCREENING AND PREVENTION.
ALTHOUGH THERE WAS IXPROVEMENT
OF PEOPLE IN RURAL AREAS IN
TERMS OF MORTALITY, THEY WERE
FALLING PROGRESSIVELY BEHIND
PEOPLE IN URBAN AREAS.
SO, WHEN WE RECOGNIZED THIS
STARTING IN 2016 IN CONJUNCTION
WITH FIRST CANCER MOONSHOT, WE
HAVE FOCUSED BOTH INITIALLY
MAINLY ON RURAL AREAS AND NOW
ALSO ON PERSISTENT POVERTY
AS-IS.
IF I INTERRUPTED, I APOLOGIZE.
WE CONCUR THAT THEY ARE REALLY
IMPORTANT AREAS.
>>YEAH.
YEAH. I DO THANK YOU SO MUCH
FOR THAT.
KRISTEN, I SEE YOU HAD YOUR HAND
UP?
>>I HAVE A BIT THAT TIES TO
THIS AS WELL. DR. LOWY, THANK
YOU FOR YOUR OVERVIEW. FOR ME,
IT WAS EASY TO FOLLOW AND DIGEST
AND I APPRECIATE IT. NICE TO
SEE YOU AGAIN.
LONGEVITY IS INTERESTED IN
INCREASING ACCESS TO WHAT
BIOMARKERS ARE SAYING AND THAT
DNA AND ALL OF THE TERMINOLOGY
CONFUSES ME AND WHY WE WORKED ON
TRYING TO STREAMLINE THAT IN THE
PAST. I HAVE A QUESTION AND
THEN A COMMENT TO WHAT ANDY WAS
SAYING AND CURIOUS AS FAR AS
WHAT IT LOOKS LIKE FOR NCI TO
CONVENE GROUPS AND SOMETHING
THAT LONGEVITY WOULD BE
INTERESTED IN AND OTHER GROUPS
YOU MENTIONED WOULD BE AS WELL
AND EXCITED TO HEAR BACK.
>>THIS IS STILL UNDER
DISCUSSION.
>>OKAY.
>>BECAUSE WE -- WE NEED TO
RESPECT THERE ARE OTHER ENTITIES
THAT SET POLICY.
WE CAN'T BE IN A POSITION OF
TELLING THEM WHAT TO DO.
BUT, WE MIGHT BE ABLE TO HELP TO
BRING TOGETHER GROUPS OF PEOPLE
THAT COULD MORE CLEARLY EXPLAIN
SOME OF THE ACCESS ISSUES AND
WHETHER THERE MIGHT BE WAYS OF
NOT MAKING THINGS PERFECT BUT
MAKING THEM BETTER.
>>THAT SOUNDS FANTASTIC. THERE
IS -- I MEAN, LOTS OF THE SAME
ISSUES THAT EXIST FOR ALL OF THE
OTHER ACCESS PROBLEMS WE SEE BUT
PROVIDER AWARENESS AND
TECHNOLOGY AND PATIENT
AWARENESS, EVERYTHING IS ALL
ROLLED UP INTO THAT.
THERE WAS A --
>>YEAH. GO AHEAD.
>>I APOLOGIZE IF I'M
INTERRUPTING BUT WE WANT TO TRY
TO START SMALL, IF YOU WILL.
IT IS NOT SOMETHING WE HAVE
TRADITIONALLY DONE.
WE WOULD LIKE TO KIND OF BE
SUCCESSFUL, YOU KNOW?
OR HELP BEING SUCCESSFUL BEFORE
EMBARKING ON TOO MANY THINGS.
NOW, I WILL TURN THE MIC BACK TO
YOU. OKAY?
>>YOU ARE NOT INTERRUPTING AT
ALL. I THINK IT MAKES SENSE.
WE ARE LOOKING AT KIND OF DOG
PILOTS AND LOOKING AT EHRS OR
GANTT CHARTS TO MAKE SURE IF
SOMEONE HAS A BIOPSY IT IS SENT
IMMEDIATELY REFLEX TESTING AND
APPLYING TO OTHER DISEASE AREAS
AS WELL AND ONCE WE APPROVE IT
AND CAN HELP MOVE THINGS ALONG
AND AGREE IT MAKES SENSE.
TO ANNIE'S POINT THERE WAS A
STUDY RECENTLY AND I FEEL
HORRIBLE BUT CAN'T REMEMBER IT
AND MAKING SURE TO POP INTO YOUR
HEADS RACIAL AND ETHNIC
MINORITIES ARE WAY BEHIND
GETTING BIOMARKER TESTING DONE
THAT IS INCREDIBLY SERVING NOT
LOOKING AT RURAL VERSUS URBAN
DON'T REMEMBER WHAT IT WAS
LOOKING AT OR IF IT IS RINGING A
BELL BUT ALL OF THE FLAGS ARE
THERE.
>>THERE IS A NUMBER OF STUDIES.
WHAT WE REALLY WANT TO FOCUS ON
IS NOT SO MUCH THE PAST AS WHAT
IS HAPPENING TODAY AND WHAT IS
LIKELY TO HAPPEN TOMORROW SO
THAT WE CAN TRY TO HAVE A
POSITIVE IMPACT ON WHAT ACTUALLY
HAPPENS TOMORROW.
>>COOL.
>>WELL, SOUNDS -- I MEAN, I
ASSUME WE ARE ALL ON BOARD.
THANKS FOR HIGHLIGHTING THAT AS
AN OPPORTUNITY.
>>I AM -- I'M BRINGING THIS TO
YOUR ATTENTION BECAUSE I THINK
THAT YOU CAN BE REALLY HELPFUL
FOR US IF WE EMBARK ON THIS.
AND WE HAVE SOME SUCCESS THAN
TRYING TO PRIORITIZE WHERE TO GO
AND HOW TO GO ABOUT DOING IT.
OKAY?
>>EXCELLENT. WE ARE ON BOARD.
IS IT PRIORITY FOR LONGEVITY?
AWESOME. THANK YOU.
>>ADDING ON TO WHAT YOU WERE
TALKING ABOUT. WE ALSO BELIEVE
IT IS A PRIORITY AT AMERICAN
BRAIN TUMOR ASSOCIATION FOR
BRAIN TUMORS AND GENETIC TESTING
AND FINDING MORE AND MORE
METHYLATION IS ALSO CRITICAL FOR
BRAIN TUMORS AND APPRECIATE
PATIENT ADVOCACY ORGANIZATIONS
AND RESEARCH COMMUNITY IN
HELPING TO DIRECT WHAT ARE MOST
IMPORTANT AREAS TO FOCUS ON IF
WE START TO COLLECT THIS TUMOR
DATA AND, YOU KNOW, MOLECULAR
DATA NOT ONLY GENETIC BUT
POTENTIALLY METHYLATION AND
OTHER AREAS OF IMPORTANCE.
>>JUST TO BRING EVERYBODY INTO
THE CONVERSATION, METHYLATION IS
IN CANCER IS A MARK THAT IS PUT
ON DNA. OKAY?
WHAT IT TENDS TO MEAN IS GENES
THAT ARE METHYLATED TEND TO BE
UNDEREXPRESSED. FREQUENTLY
MEANS THAT THEY ARE TUMOR
SUPPRESSOR GENES OR ANTICANCER
GENES.
THEY CAN HAVE A PROGNOSTIC OR
THERAPEUTIC IMPLICATIONS BECAUSE
OF INACTIVATION IN THOSE GENES
THAT CAN MAKE VERY IMPORTANT
CONTRIBUTIONS TO THE CANCER AND
ITS SEVERITY.
NICOLE, WAS THAT FAIR?
>>YES. EXACTLY. THANK YOU.
I SHOULD HAVE EXPLAINED THAT
BETTER.
>>NO. THAT IS FINE. I JUST --
YOU KNOW, I JUST THINK THAT PART
OF THIS IS WHERE -- WE ARE
EDUCATING EACH OTHER. OKAY?
REALLY IMPORTANT WHAT WE DO.
>>AS YOU MENTIONED, THERE IS AN
INCREASING UNDERSTANDING OF THE
ROLE OF SOCIAL DETERMINANTS OF
HEALTH PLACE SINCE 2014 OR 2015
AND NCCN IS IN THE PROCESS OF
MAKING SOCIAL DETERMINANTS OF
HEALTH SCREENING GUIDELINE AND
RECOMMENDATION TO CMS IDEA BEING
WE HAVE TO GO REALLY FROM A ZIP
CODE LEVEL TO INDIVIDUAL PATIENT
LEVEL UNDERSTANDING OF SOCIAL
DETERMINANTS OF HEALTH AND BEING
ABLE TO CREATE INTERVENTION
RELATED TO THAT.
ONE PUSHBACK WE GET IS CLINICAL
TRIALS FOR THAT MATTER REALLY
MEDICINE OR POLICY OR
LEGISLATION CANNOT ADDRESS
POVERTY OR ADDRESS RURALNESS OR
OVERALL SOCIAL DETERMINANTS OF
HEALTH.
HOW WOULD YOU ADVISE US THAT WE
ADDRESS PUSHBACK OR QUESTIONS.
>>I AM NOT SURE THAT I AM THE
RIGHT PERSON TO GIVE YOU AN
ANSWER.
I WOULD BE MORE THAN HAPPY TO
DISCUSS IT WITH NCI COLLEAGUES
AND TO MAKE SOME SUGGESTIONS.
OKAY?
I THINK YOU ARE ASKING A VERY
IMPORTANT QUESTION.
>>THANK YOU. NAJ ANNEL, I SEE
YOUR HAND UP.
>>THANK YOU, ANNIE AND DR.
LOWY. REALLY GREAT AND
FANTASTIC PRESENTATION.
I WANT TO CONTINUE THAT
CONVERSATION AT PARTICULARLY AS
WE TALKED ABOUT, YOU KNOW, THE
PERSISTENT POVERTY COMING DOWN
THE PIPELINE AND LOOKING AT THAT
IN RURAL AND FRONTIER AREAS.
I THINK SOMETHING I NOTICED
FREQUENTLY IS THAT THE LEADING
DEFINITION OF RURALITY IS
PRIMARILY DOMINANT.
>>SORRY LEADING DEFINITION OF
WHAT?
>>RURALITY OR BEING IN A RURAL
AREA.
>> YES. THANK YOU.
>>IS PRIMARILY DOMINATED BY
EAST COAST PERSPECTIVE OF THAT
AND NOT FOR A LONG TIME INVOLVED
A MOUNTAIN WEST, MID-WEST AND
WEST COAST PERSPECTIVE WHAT
RURALITY IS AND WE SEE THAT TERM
DIFFERENTLY ACROSS THE COUNTRY
THAT IS NOT NECESSARILY
TRANSLATING AND THINK THERE IS
KIND OF SCHOOLS OF THOUGHT OF
DEFINING WHAT IS RURAL VIA LAND
MASS OR DIVINING WHAT IS RURAL
VIA CONCENTRATION OR
POPULATIONS.
I'M WONDERING IF, YOU KNOW, THE
NCI PLANS TO PROVIDE FURTHER
GUIDANCE IN FUNDING
ANNOUNCEMENTS AND REQUEST FOR
PROPOSAL AS TO WHAT THEY ARE
DEFINING AS BEING RURAL AND IF
THEY WILL ACTUALLY DEFINE THAT
AS BEING A DISPARITY IN AND OF
ITSELF.
>>YEAH. INTERESTING POINT.
I'M SURE THAT YOU KNOW, BUT
PROBABLY MOST OF THE REST OF THE
PEOPLE DON'T KNOW THAT DR.
MONICA BURTONOLI WHO IS NCI
DIRECTOR IS FROM WYOMING AND HAS
A VERY STRONG CONNECTIONS THERE.
I DON'T KNOW THAT THEY ARE
SPECIFICALLY GOING TO BE
ADDRESSING EASTERN VERSUS
FRONTIER.
LET ME -- LET ME -- LET ME ASK
HER ABOUT THAT AND WHETHER IN --
I AM NOT SURE.
DO YOU THINK THAT THE UNIVERSITY
OF UTAH HAS BEEN DISADVANTAGED
IN THAT REGARD?
>>I WOULD SAY IN -- YES. DR.
BURTONOLI WENT TO SCHOOL OF
MEDICINE AT UNIVERSITY OF UTAH
AND HOLDS PRIVY THAT INFORMATION
AS WELL. I JUST THINK THAT IN
THE CONTEXT IS SOMETHING TO
BRING UP IN THE PERSPECTIVE THAT
SUB-WESTERN COUNTIES ARE SIZE OF
EASTERN STATES AND IF YOU DEFINE
ON COUNTY LEVEL, FOR EXAMPLE,
WHAT IS RURAL, THE DEFINITION
MAY BE VERY DIFFERENT THAT I
THINK IS SOMETHING TO JUST KEEP
IN MIND AS WE USE THIS TERM
RURAL TO ENCOMPASS.
>>THAT IS ACTION ITEM 2.
>>YES. SO, I THINK IT MIGHT BE
A DEFINITIONS THING THAT NCI MAY
WANT TO CONSIDER.
>>YEAH.
>>THANK YOU, NAJ ANNEL. JOY
YA, YOUR HAND SUP.
>>I DON'T WANT TO GO AFTER
[INDISCERNIBLE] QUESTION. IT
WAS GREAT. GREAT QUESTION. I
LOVE WHEN SOMETHING CHALLENGES
HOW WE THINK ABOUT SOMETHING OR
WHAT WE SHOULD CONSIDER AND I
HAVE A QUESTION ABOUT THE CANCER
DRUG SHORTAGE AND THANKS FOR
BRINGING THE ARTICLE TO MY
ATTENTION AND SEE THE ARTICLE IN
STACK MAGAZINE BY KRISTEN RICE
AND HEADLINE WAS CAPTIVATING AND
WAS LIKE CANCER PASH YEVENTS
SHOULD BE RIDING IN THE STREETS
ALMOST. IT IS NOT OKAY. SHE
CALLS OUT SOME IN THE ARTICLE
SHE CALLS OUT SOME DEFINITELY
ONUS ON PRIVATE SECTOR TO FIX
THIS AND CANCER PASH YEVENTS
SHOULD RIDE IN THE STREETS ABOUT
THIS. ANYTHING WE CAN OR SHOULD
DO OR TYPE OF COLLECTIVE IF
APPROPRIATE SIGN OFF OR WHO
WOULD WE SUBMIT IT?
ALL THESE -- WHAT COULD WE DO?
>>I THINK WHAT YOU COULD DO IS
SIMPLY, YOU KNOW, CALL ATTENTION
TO -- CALL ATTENTION TO THIS
PROBLEM THAT, YOU KNOW, IT
PLACES PEOPLE'S LIVES IN
JEOPARDY.
I MEAN, IT DELAYS ABILITY TO
DETERMINE IF NEW APPROACHES TO
CANCER TREATMENT WILL BE EVEN
BETTER THAN CURRENT APPROACHES.
I MEAN, IT HAS -- IT HAS MAJOR
NEGATIVE IMPLICATIONS BOTH FOR
PEOPLE WHO ARE SIMPLY, YOU KNOW,
HAVE CANCER AND NEED TREATMENT
OR THOSE THAT HAVE CANCER AND
WANT TO BE IN CLINICAL TRIALS.
I DON'T THINK THAT I HAVE A
SPECIFIC RECOMMENDATION OF HOW
TO -- OF HOW TO DO IT.
I THINK THAT CALLING ATTENTION
TO THIS PROBLEM AND THAT THIS IS
-- WHAT -- WHAT BOTHERS ME ABOUT
IT IS THAT IT IS PERSISTENT.
OKAY?
>>RIGHT.
>>IT -- IT CYCLES.
IN OTHER WORDS, SOMETIMES, YOU
KNOW, YOU GET OVER IT. WE -- WE
-- I REMEMBER TALKING ABOUT DRUG
SHORTAGE PROBLEM PROBABLY 10
YEARS AGO.
WE HAVE NOT -- IT REQUIRES IN
THE LONG RUN, I -- YOU KNOW, I'M
NOT AN EXPERT IN THIS AREA.
SEEMS TO ME THAT IT REQUIRES
STRUCTURAL CHANGE.
>>FOR SURE. I DIDN'T KNOW IF
THERE WAS ANYTHING THAT WE AS A
COLLECTIVE COULD DO.
>>YEAH.
>>AND SUBMIT THAT. ANNIE, WERE
YOU GOING TO SAY SOMETHING?
>>SURE. YOU COULD -- YOU KNOW,
I MEAN, YOU -- YOU COULD -- AMY,
WHY DON'T YOU HELP ME OUT HERE.
WHAT WOULD BE APPROPRIATE?
>>YEAH. SO, JOY, HAPPY TO KEEP
TALKING TO YOU GUYS.
AS DOUG WAS ELUDING TO, THIS IS
A PERSISTENT ISSUE.
>>SURE.
>>AND ONE THAT WE TALKED ABOUT
10 YEARS AGO THAT I THINK IS --
YOU KNOW, IT DOESN'T FALL
SQUARELY ON NCI TO FIX. THIS IS
SOMETHING ACROSS -- I THINK THAT
IS WHY WE DON'T HAVE A
PARTICULAR ASK OF YOU GUYS AND
THINK THAT REPRESENTING PATIENTS
IN THE DISCUSSION AND, YOU KNOW,
MANY ADVOCATES WORK WITH US AND
WITH FDA AND WORK ACROSS
GOVERNMENT AND WORK WITH
PHARMACEUTICAL COMPANIES AND WHY
I THINK YOU ARE IN A UNIQUE
POSITION.
YOU CAN HELP TO CONNECT THE DOTS
ACROSS -- YOU KNOW, MORE THAN
JUST MORE THAN ONE INSTITUTE OR
AGENCY, WHICH IS -- WHICH IS
WHAT WILL BE REQUIRED HERE. IT
IS A SYSTEMS ISSUE; RIGHT?
IT IS NOT -- WE TODAY WANTED TO
LET YOU KNOW HOW IT WAS
IMPACTING OUR CLINICAL TRIALS
AND LET YOU KNOW WHAT WE WERE
HEARING AND WE DON'T HAVE A
PARTICULAR ASK OF THE ADVOCACY
COMMUNITY THAT IS SPECIFIC TO
NC.
BY :
>>IF I COULD COMMENT AND IF I
STEP OUT OF BOUNDS, PLEASE STOP
ME
BUT, YOU KNOW, IN THIS BODY OF
WORK, YOU KNOW, WE ARE -- BEING
SPECIAL GOVERNMENT EMPLOYEES, WE
CANNOT, YOU KNOW, LOBBY THE
GOVERNMENT AND IN ITS OFFICIAL
CAPACITY.
THERE ARE PROFESSIONAL
ORGANIZATIONS AND ADVOCACY
ORGANIZATIONS THAT HAVE BEEN
INVOLVED IN DIFFERENT ASPECTS OF
ADDRESSING THE DRUG SHORTAGE AT
DIFFERENT LEVELS.
AND, YOU KNOW, WE CAN -- YOU
KNOW, WE CAN PERHAPS OFFLINE AND
OUTSIDE OF THE MEETING WE CAN
KIND OF CONNECT EVERYBODY WITH
OPPORTUNITIES INCLUDING A MAJOR
ONCOLOGY MEDICAL GROUP WHO HAS A
PAGE -- YOU KNOW, AN ACTION PAGE
AND THINGS TO DO.
ONE THING I WOULD LIKE TO POINT
OUT FROM THE PATIENT AND
RESEARCH ADVOCATE, YOU KNOW,
PERSPECTIVE HERE. WE HAVE TWO
THINGS KIND OF THAT WE HAVE TO
KEEP IN MIND.
THERE IS A CRISIS THAT WE
BELIEVE IS -- WHICH I'M HEARING
IS GOING TO BE A MATTER OF 6 TO
8 MONTHS.
YOU KNOW?
IT IS, YOU KNOW, A SHORT-TERM
CRISIS. TO SOMEBODY GETTING
CHEMOTHERAPY, THAT MIGHT BE, YOU
KNOW, THEIR PROGNOSIS. IT IS
NOT A SHORT-TERM CRISIS BUT IS
IMMEDIATE AND IS MORE URGENT
THAN THAT. YOU KNOW, ONCE THE
OUTRAGE KIND OF SUBSIDES FROM
THIS -- WHEN THIS CRISIS, WE
KIND OF GET PASSED IT, WE NEED
TO REALLY KEEP THE FEET TO THE
FIRE ON LONG-TERM SOLUTIONS.
SO, THAT OUR CLINICAL TRIAL AT
NCI ARE NOT ENDANGERED AS WELL
AS, YOU KNOW, PATIENTS.
I THANK YOU, DR. LOWY, FOR
SHOWING THE -- YOU KNOW, THE
IMPACT OF THE SHORTAGE ON THE
RESEARCH THAT IS HAPPENING IN
THE OPEN CLINICAL TRIALS THAT I
THINK IS THAT -- I DON'T KNOW
THAT EVERYBODY HAS THAT
INFORMATION QUITE YET.
AND YES. WE SHOULD BE RIOTING
IN THE STREETS.
BUT, NOT UNDER THIS HAT.
OKAY.
>>I WASN'T IMPLYING THAT.
>>YEAH.
>>I WAS ASKING IS THERE
SOMETHING WE COULD -- IS IT A
STATEMENT VERSUS LOBBY? IS
THERE DIFFERENT WAYS?
WE CAN TALK ABOUT IT LATER BUT
WANTED TO POSE THE QUESTION.
>>YEAH HELPFUL.
>>VICKY, DID YOU HAVE SOMETHING
TO ADD?
>>I DID. TO AMY'S POINT, I
[AUDIO BREAKING UP].
WITH SOME OF OUR SPECIALIZED
BUSINESS SCHOOL COLLEAGUES IN
STRATEGY. I BELIEVE THAT THERE
WAS ACTUALLY A PRETTY MAJOR
SHIFT IN THE ORGANIZATION OF THE
PHARMACEUTICAL COMPANIES AROUND
GENERICS ABOUT FIFTEEN YEARS
AGO.
I'M NOT A SPECIALIST IN THIS
AREA AND CONSULTING WITH WHAT
HAPPENED GLOBALLY IN THE
INDUSTRY THAT LED TO THE
NARROWING OF THE APERTURE WHAT
HAPPENS WITH GENERIC DRUG
MANUFACTURING THAT PROBABLY
WOULD BE VERY INFORMATIVE TO
UNDERSTAND WHAT THE POLICY
SOLUTIONS MIGHT BE.
>>THANK YOU, VICKY. THAT IS
VERY HELPFUL. MARTY, YOUR HAND
IS UP?
>>YES, IT IS.
THANK YOU, DR. LOWY, FOR A
REALLY THOROUGH PRESENTATION. I
APPRECIATED THAT.
MY QUESTION HAS TO DO WITH THE
GOAL -- ONE OF THE GOALS OF THE
CANCER MOONSHOT THAT IS TO
OVERCOME HEALTH DISPARITIES THAT
IS A BIG ISSUE FOR ME.
THE EXAMPLE I WOULD LIKE TO USE
IS WE KNOW THAT BLACK MEN DIE OF
PROSTATE CANCER AT MORE THAN
TWICE THE RATE OF THE REST OF
THE POPULATION.
IN MY VIEW, THAT IS NOT
NECESSARILY A RESEARCH ISSUE BUT
HEALTH DELIVERY ISSUE.
WE KNOW WHEN BLACK MEN GET
TREATMENT, FOR EXAMPLE, THROUGH
THE VA WHERE THEY HAVE EQUAL
ACCESS TO CARE AND EQUAL
OPPORTUNITY TO PARTICIPATE IN
CLINICAL TRIALS.
COST BARRIERS ARE REMOVED, ET
CETERA, ET CETERA.
OUTCOMES FOR BLACK MEN AND WHITE
WOMEN ARE THE SAME AND REALIZE
IT IS NOT PRIMARY PURPOSE OF THE
NCI TO CHANGE THE WHOLE ECONOMIC
STRUCTURE AND HEALTH CARE
DELIVERY STRUCTURE IN THE
COUNTRY AND WONDERING IF THINGS
THAT NCI CAN DO OR WE CAN DO TO
HELP MOVE FORWARD WITH
ELIMINATING SOME OF THESE --
SOME OF THE BARRIERS AND
OVERCOMING SOME OF THE
HEALTHCARE DISPARITIES.
>>SO, MARTY, THIS IS NOT AN NCI
POSITION, OKAY?
WHAT I AM GOING TO SAY.
BUT A BIG ADVANTAGE OF THE
CANCER MOONSHOT IS THAT GOAL BUT
A COMPLEMENTARY PART OF IT IS
WHAT THE BIDEN ADMINISTRATION
CALLS AN ALL OF GOVERNMENT
APPROACH.
SO, AND, YOU KNOW, FOR BETTER OR
WORSE, CANCER IS PREDOMINANTLY A
DISEASE OF OLDER PEOPLE, WHICH
MEANS THAT MEDICARE HAS A
DISPROPORTIONATE INFLUENCE AND
IMPACT ON WHAT ENDS UP GETTING
REIMBURSED AND HOW IT ENDS UP
GETTING REIMBURSED, ET CETERA.
SO, IT WOULD SEEM TO ME THAT
WHATEVER -- IF THERE ARE, IF YOU
WILL, ACCESS ISSUES STRUCTURAL
ISSUES THAT THE GOVERNMENT IN
PRINCIPLE IS POISED TO TRY TO
IMPROVE THE SITUATION REGARDLESS
WHAT AGENCY YOU ARE IN, ABOUT
YOU WHEN IT COMES TO POLICY, YOU
KNOW, CMS CAN'T RECOMMEND THINGS
THAT ARE NOT APPROVED BUT CAN DO
-- THEY PROBABLY HAVE A FAIR
AMOUNT OF LATITUDE WITH STANDARD
OF CARE AND HOW TO APPLY IT.
>>THANK YOU.
>>--
>>IF WE CAN MOVE ONL TO ANOTHER
TOPIC WILL TRIALS INCLUDE
CHILDREN WITH CANCER?
>>YES, I HAVE --
>>I DIDN'T MENTION THAT.
>>SORRY MATCH TRIAL HAD A
SEPARATE TRIAL THAT IS PEDIATRIC
MATCH AND MY UNDERSTANDING IS
COME BOW MATCH WILL BE PRETTY
MUCH FOR OLD COMERS.
>>JACK HOLD US YESTERDAY IN
ATLANTA THERE WAS -- I
APPRECIATE YOU STANDING UP FOR
KIDS AND DIDN'T KNOW WHAT TO SAY
AND ALREADY HEARD THE BLUSH.
>>YOU HAD INSIDE INFORMATION.
>>YOU HAD THE BLUSH. THAT IS
FANTASTIC.
I THINK IT IS A REALLY.
>>LET ME SAY THAT VICKY
REMINDED ME WE WORK CLOSELY ON
FDA ON THESE TRIALS AND JEFF IS
PART OF THIS --
>>THAT IS BETTER FOR PATIENTS
AND FOR RARE CANCERS THAT DON'T
HAVE A LOT OF, YOU KNOW, BIG
TRIALS GOING ON.
>>YEAH.
>>I MEAN, THIS IS LIKE --
>>ANOTHER FEATURE OF THE MATCH
TRIAL WAS THAT IF THERE WAS A
POSITIVE SIGNAL THAT WAS
PREDETERMINED PERCENT OF
RESPONSES THAT YOU COULD EXPAND
THE ARM.
>>OH.
>>YOU DIDN'T HAVE TO MAKE A NEW
TRIAL.
>>EXPANSION OF THE ARM WAS
SEMIAUTOMATIC AND MEANT THAT YOU
-- IT WAS ANOTHER WAY TRYING TO
STREAMLINE THINGS. OKAY?
>>ABSOLUTELY. WHEN WE THINK
HOW MUCH IT COSTS TO ADMINISTER
A TRIAL I'M EXCITED TO HAVE
CONVERSATION WITH THEM AS WELL.
>>I WAS GOING TO SAY HEARING
FROM HER ABOUT THE INNOVATION
CENTER WILL BE VERY INTERESTING
FOR YOU. OKAY?
>>ANYONE ELSE HAVE THOUGHTS OR
QUESTIONS?
>>YOU GO BACK TO YOUR EARLIER
PRESENTATION AROUND REDUCING
MORTALITY BY 50% IN THE NEXT 25
YEARS BEING CANCER MOONSHOTS
GOAL. THERE IS A NUANCE; RIGHT?
YOU ARE NOT SAYING WE WILL CURE
CANCER BUT REDUCE CANCER
MORTALITY RATE AND SOME CANCER
CAN BE CURED AND OTHERS ARE
NONCURABLE CANCER CAN BECOME
MORE CONIC IF YOU WOULD AND IF
YOU CAN COMMENT ON THAT AND ONE
RELATED ALSO TO THAT RATE OF
DECLINE OF DAYS TODAY I THINK
YOU MENTIONED WAS 2.3% THAT YOU
WANT TO GO TO 2.7% TO ACHIEVE A
50% RATE IS THERE TIMELINE FOR
URGENCY GOING 2.TLOO HE TO 2.7%
THAT WILL DECLINE?
>>DR. SHIELS WILL BE TALKING
AFTER ME, YOU KNOW, IS THE
EXP
EXPERT.
THE LONGER YOU ARE A 2.3, SAY
YOU ARE 2.3 FOR FIRST IT ENTO 15
YEARS AND DOING 2.7 FOR THE NEXT
10 OR 15 YEARS WON'T ACHIEVE IT.
YOU WILL NEED TO DO THREE. YOU
KNOW, OR SOMETHING LIKE THAT.
SO, THE SOONER THAT YOU CAN GET
TO 2.7, THE EASIER, IF YOU WILL,
IT WOULD BE.
BUT ONE OF THE GOALS OF THE
CANCER MOONSHOT IS WHAT
PRESIDENT BIDEN REFERS TO AS
QUOTE END CANCER AS WE KNOW IT
FOR ALL.
OUR INTERPRETATION IS THAT WE
ARE -- THIS MEANS THAT WE NEED
TO DO FOR CANCERS WHERE THERE
HASN'T BEEN MUCH ADVANCE FOR
EXAMPLE FOR PANCREATIC CANCER OR
GLEO BLASTOMAS OR RARE PEDIATRIC
CANCER WHERE'S WE HAVEN'T BEEN
ABLE TO REALLY CHANGE THE
OUTLOOK. WE HAVE TO BE ABLE TO
DO THAT AND YOU ARE NOT --
ENDING CANCER AS WE KNOW IT
DOESN'T MEAN THAT NOBODY WILL
GET CANCER.
HOPEFULLY IT MEANS THAT EVERYONE
WHO GETS CANCER HAS THE
POSSIBILITY OF AN INTERVENTION
THAT IS REALLY GOING TO BENEFIT
THEM. THAT THEY ARE -- THEIR
OUTLOOK WILL BE BETTER EVEN FOR
THOSE CANCERS WHERE WE HAVEN'T
MADE THAT KIND OF PROGRESS TO
DATE. OKAY?
I WILL GIVE YOU A EXAMPLE I'M
PERSONALLY EXCITED ABOUT THAT IS
THE RAS INHIBITORS THAT ARE NOW
ENTERING EARLY-PHASE TRIALS FOR
PANCREATIC CANCER.
10 YEARS AGO, RAS, WHICH IS
MUTATED IN LOTS OF CANCERS AND
ESPECIALLY IN PANCREATIC CANCER
WAS FELT TO BE AN UNDRUGGABLE
PROTEIN. ADVANCES LED TO FDA
APPROVAL IN TWO YEARS AGO FOR A
PARTICULAR RAS MUTATION COMMON
IN LUNG CANCER THAT IS APPROVED
FOR TREATMENTS OF LUNG CANCER
AND PARTICULAR MUTATION IS
UNCOMMON IN PANCREATIC CANCER
AND NOW ARE SEVERAL DRUG
COMPANIES DEVELOPING INHIBITORS
FOR RAS MUTATIONS COMMON IN
PANCREATIC CANCER THAT IN
PRECLINICAL STUDIES SUGGEST THAT
IT COULD -- THESE INHIBITORS
MIGHT BE HELPFUL THAT HAVE NOT
YET BEEN DEMONSTRATED. EARLY
PHASE TRIALS ARE JUST STARTING
AND THIS WOULD BE -- YOU KNOW,
THIS WOULD BE -- YOU KNOW, THIS
WOULD BE A POSSIBLE EXAMPLE OF
HOW AN AREA WHERE WE HAVE NOT
MADE MAJOR ADVANCES MIGHT BE
ABLE TO REALLY CHANGE. OKAY?
AND I'M NOT TRYING TO -- I MEAN,
IT WOULD BE GREAT. YOU KNOW,
FOR EXAMPLE, IF WE HAD CANCERS
WHERE WE COULD DO PREVENTION OR
SCREENING AND MENTIONED ANOTHER
AREA OF SCREENING WHICH IS FOR
ANAL CANCER AMONG HIV POSITIVE
PEOPLE AND A YEAR AGO A LARGE
MULTICENTERED TRIAL WAS
CONDUCTED THAT SHOWED THAT IF
THOSE PEOPLE HAD HIGH DISPLASIA
PEOPLE IN THE TRIAL THAT
TREATMENT OF THAT DYSPLASIA LED
TO DRAMATIC DECREASE IN RATE OF
PROGRESSION TO INVASIVE ANAL
CANCER. THIS IS AN AREA OF
SCREENING THAT IS NOT YET
STANDARD OF CARE. BUT, THE
CENTERS FOR DISEASE CONTROL IS
IN THE PROCESS AND THEY HAVE
SAID THIS EXPLICITLY OF
DEVELOPING GUIDELINES FOR ANAL
CANCER SCREENING AND THESE ARE
AREAS WHERE THERE IS POTENTIAL
FOR ADVANCES AND IS IT
EVERYTHING?
NOT YET.
>>YEAH. I KIND OF HAVE ON THAT
AND TO CANCER AS WE KNOW IT
BECAUSE I KIND OF SEE IT AS A
SLIDING SCALE. YOU KNOW,
WHEREVER, YOU KNOW, A PATIENT'S
CURRENT PROGNOSIS OUTLOOK
QUALITY OF LIFE WILL BE TO JUST
IMPROVE, YOU KNOW, ACROSS THE
BOARD AS BEST AS WE CAN. FOR
SOME PEOPLE, YOU KNOW, WE KNOW
THAT SOME PEOPLE HAVE REALLY
GREAT OUTCOMES AND FOR SOME
PEOPLE LIVING WITH CANCER PIECE
OF IT IS ACTUALLY A GOOD
OUTCOME.
IS IT -- THE NO. 1 DESIRED
OUTCOME? PROBABLY NOT.
I THINK THAT WHEN I THOUGHT I
WAS LIVING WITH CHRONIC CANCER,
IF THAT WAS ALL THAT WAS ON THE
TABLE FOR ME, I WANTED AS MUCH
AS I COULD GET; RIGHT?
I THINK THAT PHRASEOLOGY, I
THINK WHEN WE GET, YOU KNOW, SO
MUCH IS CURE CENTRIC. THAT HAS
BEEN REALLY HARD TO REACH FOR
PEOPLE. IF WE CAN MAKE A STEP
IN THE RIGHT DIRECTION AND FOCUS
ON OTHER THINGS, I THINK THAT,
YOU KNOW, PEOPLE BENEFIT IN
OTHER PLACES AS WELL.
MY TWO CENTS THERE. IT LOOKS
LIKE TIME WITH DR. LOWY IS -- WE
HAVE THREE MINUTES LEFT TO HOLD
THEM HERE. IF ANY -- IF ANYONE
HAS ANY OTHER QUESTIONS THAT WE
WANT TO BRING FORTH, COMMENTS?
>>THANK YOU, EVERYONE.
AT LEAST AS MUCH AS FOR YOUR
COMMENTS AS FOR YOUR QUESTIONS,
OKAY?
TERRIFIC SEEING EVERYONE AGAIN.
YOU ARE GOING -- AMY AND
COLLEAGUES PUT TOGETHER WITH
ANNIE'S PARTICIPATION. YOU
KNOW, WHAT IS REALLY AN
INTERESTING SET OF DISCUSSIONS
FOR YOU.
>>THANK YOU FOR SPENDING SO
MUCH TIME WITH US AND ON THIS
WONDERFUL DIALOGUE. WE REALLY
APPRECIATE IT AND ENJOY THE REST
OF YOUR DAY.
OKAY. THAT WAS REALLY GREAT.
I'M HAPPY TO WELCOME THE NEXT
SPEAKER DR. SHIELS IS SENIOR
INVESTIGATOR IN INFECTIONS IN
IMM
IMMUNOEPIDEMIOLOGY --
EPIDEMIOLOGY AND GENETICS YOU
HAVE BEEN SET UP REALLY NICELY.
WE ARE LOOKING FORWARD TO
HEARING YOUR PRESENTATION ABOUT
YOUR WORK.
>>THANK YOU SO MUCH. I HAVE
BEEN LISTENING THE LAST 15 OR 20
MINUTES AND EXCITED TO PRESENT
TO THE GROUP. IT WILL BE NEW TO
ME AND THANKS FOR THE
INVITATION.
NEXT SLIDE, PLEASE.
>>SO, I WANTED TO START WITH AN
OVERVIEW OF MY PRESENTATION FOR
TODAY.
I WILL BE PRESENTING ON A
MANUSCRIPT THAT WE RECENTLY
PUBLISHED IN JOURNAL CANCER
DISCOVERY.
THIS PUBLICATION REPRESENTS A
COLLABORATION BETWEEN PRINCIPLE
INVESTIGATORS AND IN INTRA MURAL
PROGRAMS OF THE NATIONAL CANCER
INSTITUTE AND CENTER FOR CANCER
RESEARCH AS WELL AS MY DIVISION
AND DIVISION OF CANCER
EPIDEMIOLOGY AND GENETICS AND
THIS PROJECT GREW OUT OF REQUEST
FROM DR. LOWY TO EXAMINE
FEASIBILITY OF PRESIDENT BIDEN'S
CANCER MOONSHOT GOAL. NEXT
SLIDE, PLEASE.
AS A REVIEW, CANCER MOONSHOT
PROGRAM WAS LAUNCHED UNDER
LEADERSHIP OF THEN VICE
PRESIDENT JOE BIDEN IN 2016 TO
SPEED PROGRESS FROM CANCER
PREVENTION TO SURVIVORSHIP. IN
2016, 21ST CENTURY CURES ACT
DEVOTED $1.8 BILLION OVER 7
YEARS TO CANCER MOONSHOT-DRIVEN
RESEARCH AT NCI FOCUSING ON
ACCELERATING SCIENTIFIC
DISCOVERY FOSTERING GREATER
COLLABATION AND DATA SHARING.
NEXT SLIDE, PLEASE.
JUST ABOUT A YEAR AND A HALF AGO
ON FEBRUARY 2ND, 2022, PRESIDENT
BIDEN AND FIRST LADY DR. BIDEN
REIGNITED THE CANCER MOONSHOT
LAYING OUT TWO NEW GOALS AND
FIRST TO REDUCE AGE-STANDARDIZED
CANCER MORTALITY RATES BY AT
LEAST 50% OVER THE NEXT 25 YEARS
AND SECOND AS WE WERE DISCUSSING
IS TO IMPROVE EXPERIENCE OF
PEOPLE AND FAMILIES LIVING WITH
AND SURVIVING CANCER ENDING
QUOTE CANCER AS WE KNOW IT.
NEXT SLIDE, PLEASE.
MY PRESENTATION TODAY WILL FOCUS
ON THE FIRST OF THE GOALS TO
REDUCE AGE STANDARDIZED CANCER
MORTALITY RATES BY 50% OVER THE
NEXT 25 YEARS.
SPECIFICALLY IN THIS ANALYSIS,
WE FOCUS HONEST MEATING CANCER
DEATH RATES IN 2047 IF CURRENT
TRENDS CONTINUE.
WE REALLY FOCUSED ON THE 6
LEADING CAUSES OF CANCER DEATH
AS THEY CAUSE MORE THAN 50% OF
ALL CANCER DEATHS.
AND THEN IDENTIFIED SOME OF THE
PROMISING AND REALISTIC
OPPORTUNITIES TO FURTHER REDUCE
CANCER DEATH RATES OVER THE NEXT
25 YEARS.
NEXT SLIDE, PLEASE.
SO, THIS PARTICULAR EFFORT
FOCUSES ON SPECIFIC
OPPORTUNITIES TO ACHIEVE ONE OF
THE NEW MOONSHOT GOALS.
I WANTED TO EMPHASIZE LESS
COMMON CANCERS INCLUDING
PEDIATRIC CANCERS AND EXPOSURES
ARE IMPORTANT AND SHOULD BE
STUDIED AND CONTENTS OF PAPER
AND PRESENTATIONS ARE NOT
SPECIFIC RECOMMENDATIONS FOR
WHAT NCI OR DCG THAT IS THE
DIVISION I WORK IN SHOULD BE
PRIORITIZING.
NEXT SLIDE, PLEASE.
THE PAPER THAT WE PUBLISHED WAS
ACCOMPANIED BY COMMENTARY
WRITTEN BY DR. BURTON OELI AND
WHITE HOUSE MOONSHOT COORDINATOR
AND ELIZABETH JAVY AT JOHNS
HOPKINS TITLE OF COMMENTARY WAS
ACHIEVING THE GOALS OF THE
CANCER MOONSHOT REQUIRES
PROGRESS AGAINST ALL CANCERS AND
COMMENTARY HIGHLIGHTED
IMPORTANCE OF PROGRESS OF
MORTALITY ACROSS ALL CANCER
TYPES INCLUDING LESS COMMON
SITES.
NEXT SLIDE, PLEASE.
THIS WORK WAS LED BY A TEAM OF
RESEARCHERS SHOWN HERE AMY
BERINGTON AT ICR AND NEAL
FRIEDMAN IN DCCPS MARK SHIFMAN
AND JOHN SHILER AND STANLEY
LIPKOWITZ AND [INDISCERNIBLE]
WHO IS AT HARVARD. NEXT SLIDE,
PLEASE.
THIS TABLE SHOWS LEADING
CAUSESES OF CANCER DEATH IN YEAR
2019.
NEXT SLIDE, PLEASE.
>>WE FOCUS ANALYSIS ON THE 6
LEADING CANCER SITES IN TERMS OF
MORTALITY AND INCLUDING LUNG
CANCER THAT CAUSES NEARLY 1 OUT
OF 4 CANCER DEATHS IN THE UNITED
STATES COLORECTAL CANCER
PANCREATIC CANCER FEMALE BREAST
CANCER PROSTATE CANCER AND LIVER
CANCER AND THESE CAUSE 56% OF
DEATHS IN MEN AND 57% IN WOMEN
AND GOAL OUTLINED IN MOONSHOT IS
A NUMERIC GOAL PROGRESS AGAINST
MOST COMMON CANCERS THAT IS
REQUIRED TO REACH THIS 50% GOAL.
NEXT SLIDE, PLEASE.
THE APPROACH THAT WE USED IN
THIS ANALYSIS WAS TO ESTIMATE
TRENDS IN CANCER INCIDENCE AND
RELATIVE SURVIVAL AND MORTALITY
AND DATA CAME FROM THE SEER
PROGRAM THAT IS A GROUP OF
CANCER REGISTRIES COVERING
NEARLY HALF OF THE UNITED STATES
THAT ARE FUNDED BY NATIONAL
CANCER INSTITUTE.
AS WELL AS NATIONAL DEATH
CERTIFICATE DATA FROM THE
NATIONAL CENTER FOR HEALTH
STATISTICS AND WE PROJECTED
MORTALITY RATES FROM 20202 TO
20047 BASED ON RECENT TREND AND
CANCER RATES IDENTIFIED FOR
MODELS THAT PICK UP WHERE TRENDS
CHANGE OVER TIME.
PROJECTIONS THAT WE MADE ASSUME
THE MOST RECENT TREND WILL
CONTINUE FROM 2022 2047 AND
PROJECTIONS ARE NOT PREDICTIONS
WE DON'T THINK WE ARE GETTING
EXACT CANCER RATES FOR 2047
CORRECT HOWEVER IT PROVIDES
OVERALL PICTURE WHETHER OR NOT
WE ARE ON OR OFF TRACK TO MEET
THE MOONSHOT GOAL. NEXT SLIDE,
PLEASE.
SO, I WILL SHOW A SERIES OF
SLIDES THAT IS STARTING WITH
TOTAL CANCER AND GOING THROUGH
EACH OF THE 6 SITES WE
HIGHLIGHTED SHOWING INCIDENCE
RATES RELATIVE SURVIVAL AND
MORTALITY RATES.
X AXIS IS CALENDAR YEAR AND Y
AXIS IS AGE STANDARDIZED
INCIDENCE RATE. YOU CAN SEE IN
THE MOST RECENT TIME PERIOD THAT
FOR THIS CANCER TOTAL CANCER
STARTED IN 2012 AND WAS A .6%
PER YEAR DECLINE IN INCIDENCE
RATES RELATIVE SURVIVAL THAT IS
A MEASURE OF SURVIVAL IN PEOPLE
WITH CANCER RELATIVE TO WHAT
SURVIVAL WOULD BE IN GENERAL
POPULATION FOR SOMEBODY OF THE
SAME AGE, SEX, AND RACE. WE SAW
IMPROVED SURVIVAL 1 AND 3 YEARS
SURVIVAL IN MOST RECENT TIME
PERIOD.
NEXT SLIDE, PLEASE.
SO, CANCER MORTALITY RATES IS
REALLY WHAT WE ARE FOCUSING ON
HERE FOR MOONSHOT GOAL.
YOU CAN SEE HERE THAT OVER THE
LAST 20 YEARS THERE HAS BEEN
TREMENDOUS PROGRESS IN CANCER
MORTALITY RATE REDUCTION.
IN FACT, IF IN THE MOST RECENT
TRENDS SHOWN HERE IN THE LAST
FEW YEARS, RATE OF DECLINE
ACCELERATED TO 2.3% PER YEAR.
NEXT SLIDE, PLEASE.
IF THIS TREND CONTINUES THAT
WOULD TAKE A TREMENDOUS AMOUNT
OF WORK AND WOULD BE A HUGE
SUCCESS, WE WOULD SEE A 44%
DECLINE IN CANCER DEATH RATES
FROM 2022 TO 2047 THAT IS A HUGE
NUMBER OF CANCER DEATHS AVOIDED
BUT WOULD FALL SOMEWHAT SHORT OF
MOONSHOT GOAL OF 50% DECLINE.
AS DISCUSSED BEFORE WE NEED TO
ACCELERATE DECLINE OF 2.7% EACH
YEAR TO MEET THIS GOAL. NEXT
SLIDE, PLEASE.
WHEN WE OUTLINED APPROACHES TO
ACCELERATE PROGRESS, WE REALIZED
THEY SHOULD BE CANCER-TYPE
SPECIFIC ETIOLOGY AND PREVENTION
A
TREATMENT ALL DIFFER BY SITE AND
HIGHLIGHT ESTABLISHED
INTERVENTIONS REDUCING CANCER
DEATHS OVER 25 YEAR PERIOD THAT
DOESN'T DISCOUNT IMPORTANCE OF
DISCOVERY AND CONTINUED EFFORTS
TO DEVELOP NEW APPROACHES TO
PREVENT, DISCOVER AND TREAT
CANCER.
NEXT SLIDE, PLEASE.
I WANT TO MAKE A NOTE ABOUT
MODIFIABLE RISK FACTORS AND
CIGARETTE SMOKING OBESITY
PHYSICAL ACTIVITY AND ALCOHOL
INTAKE CONTRIBUTE TO MORTALITY
FOR CANCER TYPES AS WELL AS
OTHER CHRONIC DISEASES AND
PROGRESS AGAINST RISK FACTORS IS
CRITICALLY IMPORTANT.
HOWEVER, POPULATION LEVEL
INTERVENTIONS TO REDUCE RISK
FACTORS ARE CHALLENGING AND
ACCEPT CRIMINAL RECEIPT SMOKING
HERE IS CHALLENGING AND WE HAVE
SEEN GREAT SUCCESS FOR SMOKING.
NEXT SLIDE, PLEASE.
AS AN EXAMPLE OF THIS, I'M
SHOWING YOU FROM THE NATIONAL
CENTER FOR HEALTH STATISTICS
DATA ON US OBESITY PREVALENCE
AND ALCOHOL INDUCED DEATH RATES
PROXY FORALCOHOL CONSUMPTION AND
SEE THAT OBESITY IN THE
INCREASED FROM 30.5% OF
POPULATION IN 1999 IN 2000 TO
44% IN 2017 AND 2018 AND WE HAVE
SEEN ALSO INCREASES IN ALCOHOL
INDUCED DEATH RATES.
NEXT SLIDE, PLEASE.
SO, SUCCESSFUL POPULATION
EFFORTS TO INCREASE PHYSICAL
ACTIVITY DECREASE OBESITY AND
ALCOHOL CONSUMPTION WOULD LOWER
DEATH RATES FROM CANCER AND
CHRONIC DISEASES THAT ARE REALLY
IMPORTANT AND AS I SHOWED YOU
THESE EXPOSURES ARE HEADED IN
THE WRONG DIRECTION THAT WILL
LIKELY TAKE LONGER THAN 25 YEAR
TIMEFRAME TO REVERSE CURRENT
TRENDS AND OBSERVE IMPACTS AT
THE POPULATION LEVEL.
NEXT SLIDE, PLEASE.
SGLT THIS ANLAL SIS AND STUDY
ALSO DID NOT FOCUS A LOT ON
CANCER TREATMENTS AND SORRY WE
ONLY FOCUS ON TREATMENTS WITH
LARGE SURVIVAL BENEFITS FOR
SUBSTANTIAL FRACTION OF CANCER
PATIENTS AND DIDN'T FOCUS ON
TREATMENTS WITH LIMITED SURVIVAL
BENEFITS THOUGH THEY ARE
TREMENDOUS WILL I IMPORTANT, OF
COURSE, FOR INDIVIDUAL PATIENTS
THEY UNLIKE WILL I TO HAVE AN
IMPACT AT POPULATION LEVEL ON
CANCER MORTALITY RATES.
NEXT SLIDE, PLEASE.
I ALSO WANT TO HIGHLIGHT THE
IMPORTANCE OF ADDRESSING
DISPARITIES TO REACH THIS
MOONSHOT GOAL AND ARE WELL-KNOWN
DISPARITIES IN CANCER PREVENTION
EARLY DETECTION AND TREATMENT
AND CRITICAL THAT THESE
INEQUITIES BE ADDRESSED IN
OPPORTUNITIES THAT WERE OUTLINED
AND THIS FIGURE SHOWS THE
DIFFERENCES IN CANCER MORTALITY
RATES ACROSS MAJOR RACIAL/ETHNIC
GROUPS IN THE UNITED STATES AND
FOR EXAMPLE SHOWS IN BOTH MEN
AND WOMEN BLACK INDIVIDUALS HAVE
THE HIGHEST CANCER DEATH RATES
AND IN FAR HIGHER THAN SOME OF
THE OTHER GROUPS SHOWN HERE.
NEXT SLIDE, PLEASE.
SO, NOW I WILL START TO GO
THROUGH INDIVIDUAL CANCER TYPES
EXAMINED IN OUR STUDY AND --
WITH 2.3% DECLINE OVER THE
PERIOD 2007 TO 2019 AND
INCREASED DRAMATICALLY AND
REMAINS POOR. NEXT SLIDE,
PLEASE.
WHEN WE EXAMINED CANCER
MORTALITY RATES FOR LUNG CANCER
WE SAW A STRONG DECLINE AT 4.7%
PER YEAR IN THE MOST RECENT TIME
PERIOD.
IF THIS DECLINE CONTINUES FOR
LUNG CANCER THERE WILL BE A
MEETING AND SURPASSING OF 50%
GOAL OVER THE NEXT 25 YEARS NEXT
SLIDE.
I WILL SHOW CANCER TYPE
POTENTIAL INTERVENTIONS
OPPORTUNITIES TO ACCELERATE
PROGRESS AND OPPORTUNITIES TO
PREVENT CANCER OR IN THIS CASE
OUTCOME BEING INCIDENCE TO
PREVENT INCIDENCE OF CANCER
REDUCING THEM AS WELL AS
MORTALITY AND FOR LUNG CANCER,
OF COURSE, IMPORTANT WAY OF
PREVENTING LUNG CANCER IS
THROUGH SMOKING CESSATION AND
PREVENTING INITIATION OF
CIGARETTE SMOKING AND NEXT
SLIDE, PLEASE.
>>SMOKING PREVALENCE IN US HAS
BEEN ON DECLINE FOR DEGATES AND
TREMENDOUS PROGRESS GETTING
PEOPLE TO QUIT AND PREVENTION OF
SMOKING IN FIRST PLACE AND IN
EARLY 1990S TO LATER 20 TENS
PREVALENCE OF INDIVIDUALS THAT
WERE NEVER SMOKERS INCREASED
FROM 50 TO 70%.
NEXT SLIDE, PLEASE.
IMPORTANT THING TO CONSIDER FOR
CIGARETTE SMOKING GIVING ME HOPE
FOR MOONSHOT GOAL FOR LUNG
CANCER IS RECENT YEARS HAVE NOT
IMPACTED LUNG CANCER RATE DEATH
RATES.
EXAMPLE OF THIS, YOU SEE THIS
FIGURE TO THE RIGHT. ON THE Y
AXIS PRESENTS NUMBER OF
CIGARETTES IN THE UNITED STATES
PER CAPITIA.
YOU SEE THAT NUMBER PEAKED WITH
1964 SURGEON GENERAL'S REPORT
AND NOT UNTIL SEVERAL DECADES
LATER THAT LUNG CANCER MORTALITY
RATES PEAKED SHOWING LAG BETWEEN
POPULATION LEVEL SMOKING AND
POPULATION LEVEL MORTALITY.
SO, MUCH OF THE PROGRESS THAT
HAS HAPPENED IN THE LAST COUPLE
DECADES AGAINST CIGARETTE
SMOKING HAVE NOT PLAYED OUT IN
THE POPULATION LEVEL LUNG CANCER
MORTALITY DATA.
THAT IS A PROMISING POINT TO ME.
IN ADDITION 2% OF HIGH SCHOOL
STUDENTS REPORTED CIGARETTE
SMOKING IN 2022 AND FEW
INDIVIDUALS INITIATING SMOKING
AGAIN THAT IS REALLY GREAT NEWS
AND FDA PROPOSED NEW TOBACCO
PRODUCT STANDARDS PROHIBITING
MENTHOL IN CIGARETTE ROOEZ
DEUCING NICOTINE WITH IMPACT ON
SMOKING CESSATION AND PREVENTING
INITIATION. NEXT SLIDE, PLEASE.
IT IS IMPORTANT TO POINT OUT
THOUGH THAT PREVALENCE OF
SMOKING IS ALL TIME LOW NOTABLE
DISPARITIES BY EDUCATION IN THE
UNITED STATES FIGURE PRESENTS
DATA FROM CDC AND THOSE WITH
GRADUATE DEGREE PREVALENCE OF
SMOKING 3.5% THOSE WITHOUT HIGH
SCHOOL DIPLOMA HAVE HIGHER
SMOKING PREVALENCE AT 21.5%.
NEXT SLIDE, PLEASE.
IT IS IMPORTANT TO NOTE SMOKING
AND PREVENTING SMOKING WILL HAVE
IMPACT ON MANY CANCER TYPES AND
MANY OTHER DISEASES SMOKING IS
KNOWN TO CAUSE MANY CANCERS
SHOWN HERE PROGRESS AGAINST
SMOKING COULD HAVE A BROAD
IMPACT ON CANCER RATES.
NEXT SLIDE, PLEASE.
I WOULD LIKE TO TALK ABOUT
INTERVENTIONS TO PREVENT LUNG
CANCER MORTALITY AMONG THOSE
WITH LUNG CANCER AND ONE
OPPORTUNITY IS TO INCREASE
ACCESS TO LOW DOSE CT SCANS FOR
SCREENING AND EARLY DETECTION OF
LUNG CANCER, NEXT SLIDE, PLEASE.
TRIALS HAVE SHOWN HIGH RISK
POPULATIONS FOR LUNG CANCER
REDUT MORTALITY BY 20% AND CDC
SCHEMATIC SHOWS 7 OUT OF 8
ADULTS MEETING SCREENING
CRITERIA. SORRY 1 OF 8 ADULTS
MEETING SCREENING CRITERIA
REPORTED RECOMMENDED SCREENING
AND 7 OUT OF 8 DID NOT AND YOU
SEE CRITERIA FOR SCREENING
PROGRAMS ON RIGHT BASED ON AGE
AND SMOKING HISTORY. NEXT
SLIDE, PLEASE.
THERE IS TREMENDOUS POTENTIAL
FOR EXPANDING ACCESS TO LOW DOSE
CONSIDER. T SCANS SCREENING
LUNG CANCER REDUCING MORTALITY
FROM LUNG CANCER AND IMPORTANT
TO POINT OUT THOUGH THERE ARE
LARGE DISPARITIES IN ACCESS TO
LOW DOSE CT SCREENING CENTERS IN
THIS STUDY THAT SHOWED AT COUNTY
LEVEL WHERE THE SCREENING
CENTERS ARE LOCATED IN THE
STATES OF MISSOURI AND ILLINOIS
THAT IS THE BLACK DOTS ON MAPS
AND AT THE COUNTY LEVEL THE
COLORS INDICATE THAT THERE IS
PERCENTAGE OF RESIDENTS OF AGE
5579 WITH ACCESS TO SCREENING
CENTER WITHIN 30 MILES AND SEE
THAT THERE ARE LARGE PARTS OF
THE STATE WHERE 0% THAT IS RED
THAT HAVE ACCESS TO A LOW-DOSE
CD SCAN SCREENING CENTER WITHIN
30 MILES HIGHLIGHT DISPARITIES
AND ACCESS TO SCREENING MODALITY
AND NEXT SLIDE, PLEASE.
FINALLY, THERE IS OPPORTUNITIES
TO PREVENT MORTALITY DUE TO LUNG
CANCER REDUCING DISPARITIES AND
ACCESS TO EFFECTIVE TREATMENTS.
NEXT SLIDE, PLEASE NONSMALL CELL
LUNG CANCER TREATMENTS AND THOSE
IN THE US ARE OF THIS CELL TYPE.
TARGETED THERAPIES HAVE RESULTED
IN POPULATION LEVEL DECLINES IN
LUNG CANCER MORTALITY.
NEXT SLIDE, PLEASE.
THIS STUDY DEMONSTRATED THIS
POINT BY COMPARING TRENDS AND
INCIDENT RATES TO TRENDS IN
MORTALITY RATES SHOWN IN RED FOR
MEN AND WOMEN.
THIS STUDY SHOWED WHEN
THERAPIES WERE INTRODUCED THERE
WAS ACCELERATION IN DECLINE IN
MORTALITY WHEN THERE WASN'T
ACCELERATION IN INCIDENCE THAT
WAS INDIRECT WAY OF SHOWING THE
IMPACT OF TREATMENT ON
POPULATION LEVEL MORTALITY
RATES.
NEXT SLIDE, PLEASE.
IT IS IMPORTANT TO NOTE EXPANDED
ACCESS TO EFFECTIVE TREATMENTS
IS NEEDED TO MAXIMIZE BENEFITS
OF TREATMENT MODALITIES.
NEXT SLIDE, PLEASE.
SECOND LEADING CAUSE OF CANCER
-- 2.4% PER YEAR IN RECENT YEARS
AND WHILE NO BENEFIT AND
INCREASES IN SURVIVAL OVER THE
SAME TIME PERIOD.
NEXT SLIDE, PLEASE.
MORTALITY RATES COLORECTAL
CANCER DECLINED 2% PER YEAR
BETWEEN 2019 AND 2010 AND IF
THIS CONTINUES IN GOAL OR 50%
DECLINE AND THERE ARE SEVERAL
OPPORTUNITIES TO ACCELERATE
DECLINES IN COLORECTAL CANCER
THOUGH THAT ALL ARE INVOLVED
AROUND SCREENING THAT IS FOR
COLORECTAL CANCER PREVENTION OF
POLYPS BEFORE THEY BECOME
CANCERS AS WELL AS EARLY
DETECTION.
NEXT SLIDE, PLEASE.
USPSTF GUIDELINES FOR COLORECTAL
CANCER SCREENING OFFER A NUMBER
OF TYPES OF SCREENING TO BE USED
TO SCREEN FOR COLORECTAL CANCER
AT OUTLINED HERE FOR INDIVIDUALS
AGE 45 TO 75. NEXT SLIDE,
PLEASE.
DATA SHOWS HOW WELL SCREENING
FOR COLORECTAL CANCER WORKS.
NON-INVASIVE METHODS INCLUDE
FECAL BLOOD TEST AND FECAL
IMMUNOCHEMICAL TEST THAT REDUCE
MORTALITIES BETWEEN 9 AND 22%.
WHILE DIRECT VISUALIZATION
METHODS ARE MORE INVASIVE
METHODS PREVENTING POLYP REMOVAL
REDUCE MORTALITY 68% AND 26%
WITH SCREENING WITH FLEXIBLE
SIGMOIDOSCOPY EVERY THREE TO 5
YEARS.
NEXT SLIDE, PLEASE.
THERE IS ROOM FOR IMPROVEMENT
WITH UPTAKE OF COLORECTAL
SCREENING AND DATA SHOWS
PERCENTAGE OF ADULTS AGE 50 TO
75 THAT ARE UP TO DATE WITH
SCREENING AND LOOKING AT CIRCLES
AT BOT OWE M THAT ARE AGE
STRATIFIED YOU SEE ABOUT 62% OF
50 TO 64 YEAR OLDS IN 2018 AND
7% OF 65 TO 75 YEAR OLDS WERE UP
TO DATE WITH COLORECTAL
SCREENING AND NUMBERS FOR
COLONOSCOPY WERE 56% IN YOUNGER
AGE GROUP AND 71% IN OLDER AGE
GROUP THERE IS ROOM FOR
IMPROVEMENT WITH SCREENING IN
COLORECTAL CANCER IN YOUNGER AGE
GROUP OF 50 TO 64 AND
RECOMMENDED SCREENING STARTS AT
AGE 45 NOW. NEXT SLIDE, PLEASE.
FOR THOSE OPTING FOR
NON-INVASIVE SCREENING
TECHNIQUES IS CRITICALLY
IMPORTANT THAT POSITIVE RESULTS
BE FOLLOWED UCH AND THAT POLYP
REMOVAL OCCURS IF POLYPS ARE
PRESENT AND WHAT THIS SLIDE IS
SHOWING IS PERCENT OF
INDIVIDUALS WITH POSITIVE SCREEN
FOLLOWING UP WITH DIAGNOSTIC
EVALUATION AND LETTERS EFGH
INDICATE SCREENING CENTERS IN
THE STUDY AND ACROSS CENTERS
BETWEEN 46 AND 81% OF
INDIVIDUALS SCREENING POSITIVE
FROM LOW NON-INVASIVE TESTS
FOLLOWED UP TO ACTUALLY GET
DIAGNOSTIC EVALUATION AND GET
POLYPS REMOVED IF THEY WERE
PRESENT.
NEXT SLIDE, PLEASE.
PANCREATIC CANCER IS THIRD
LEADING CAUSE OF CANCER DEATH IN
THE UNITED STATES.
UNFORTUNA
UNFORTUNATELY INCIDENCE RATES
IMPROVE AND 1 YEAR SURVIVAL IN
MOST RECENT YEAR WAS BELOW 40%
STILL.
NEXT SLIDE, PLEASE.
UNFORTUNATELY MORTALITY RATES
ARE HEADED IN THE WRONG
DIRECTION.
NEXT SLIDE, PLEASE PAN CREATIC
CANCER DETECTION AND PREVENTION
IS CHALLENGING MODIFIABLE RISK
FACTORS CAUSE ONLY ABOUT 1 IN 4
CASES OF PANCREATIC CANCER AND
DIFFICULT TO DETECT AT EARLY
STAGE. SURGERY OF EARLY STAGE
PANCREATIC CANCER IS ONLY
CURATIVE TREATMENT. AS YOU CAN
SEE FROM THIS BAR GRAPH OF STAGE
DIAGNOSIS ONLY 10 TO 20% OF
PATIENTS ARE DIAGNOSED AT
LOCALIZED OR EARLY STAGE.
NEXT SLIDE, PLEASE.
AS DR. LOWY MENTIONED DISCUSSING
ASKING QUESTIONS PRIOR TO TALK
POTENTIAL PROMISE AND TREATMENT
IS DEVELOPMENT OF NEW MUTANT
KRAS INHIBITORS.
NEXT SLIDE, PLEASE.
MUTANT KRAS IS DRIVER MUTATION
IN 90% PAN CREATTIC CANCERS
INHIBITORS FOR THESE MUTATIONS
ARE UNDER ACTIVE DEVELOPMENT
TREATMENT HOLDS GREATEST PROMISE
INCREASING SURVIVAL OF
SUBSTANTIAL FRACTION OF
PANCREATIC CANCER PATIENTS IN
THE FUTURE.
NEXT SLIDE, PLEASE BREAST CANCER
INCIDENTS HAS INCREASED SLIGHTLY
OVER THE LAST 15 YEARS.
AND SURVIVAL HAS INCREASED
SOMEWHAT AND IS QUITE HIGH FOR
ONE YEAR SURVIVAL OR ALL
CATEGORIES OF SURVIVAL THAT IS
QUITE HIGH NEXT SLIDE, PLEASE.
MORTALITY RATES FOR BREAST
CANCER DECLINED 1.2% IN RECENT
TIME PERIOD.
AGAIN, TELLING US THAT WE NEED
TO ACCELERATE PROGRESS AGAINST
BREAST CANCER MORTALITY.
NEXT SLIDE, PLEASE.
IN TERMS OF PREVENTING BREAST
CANCER OPPORTUNITY IS TO
EVALUATE EFFICACY OF LOW-DOSE
HORMONE THERAPIES AND IMPROVE
RISK STRATIFICATION. NEXT
SLIDE, PLEASE.
HORMONE THERAPY REDUCES BREAST
CANCER IN HIGH-RISK WOMEN AND
HAS BEEN SHOWN TO REDUCE RISK OF
ER POSITIVE BREAST CANCER BY
BETWEEN 50 TO 65% WHILE ER
NEGATIVE BREAST CANCERS ARE
KNOWN TO BE MORE FATAL ER
POSITIVE BREAST CANCERS YOU CAN
SEE ON THE LEFT CAUSE ACTUALLY
MORE THAN 50% OF ALL BREAST
CANCER DEATHS INCLUDING IN
YOUNGER WOMEN. THERE ARE ABOUT
10 MILLION WOMEN WHO ARE
ELIGIBLE FOR HORMONE THERAPIES
AND LESS THAN 10% RECEIVE THEM.
LOTS HAS TO DO WITH
SIDE-EFFECTS.
MEDICATIONS WITH FEWER SIDE
EFFECTS AND RISK STRATIFICATION
TO IDENTIFY WOMEN WHO WOULD
BENEFIT MOST FROM MEDICATIONS
MAY IMPROVE RISK BENEFIT OF
HORMONAL THERAPIES.
NEXT SLIDE, PLEASE.
THERE IS DATA YOU THAT
INCREASING PHYSICAL ACTIVITY
DECREASING OBESY IN BREAST
CANCER SURVIVORS CAN INCREASE
RISK MORTALITY AND POST
DIAGNOSIS COULD PLAY ROLE FOR
BREAST CANCER MORTALITY
PREVENTION.
NEXT SLIDE, PLEASE SCREENING IS
IMPORTANT TOOL FOR BREAST CANCER
PREVENTION AND UPTAKE AMONG
UNDERSERVED POPULATIONS WOULD
REDUCE BREAST CANCER MORTALITY.
NEXT SLIDE, PLEASE.
WE KNOW FROM STUDIES MAMMOGRAPH
REDUCES BREAST CANCER MORTALITY
FROM 10 TO 30% AND ARE
DISPARITIES IN ACCESS AND DATA
FROM MM AND MWR REPORT SHOW FOR
EXAMPLE WOMEN THAT ARE UNINSURED
AND WOMEN WITH LESS THAN A HIGH
SCHOOL EDUCATION AND THOSE WHO
LIVE IN AREAS FAR BELOW POVERTY
THRESHOLD ARE FAR LESS LIKELY TO
RECEIVE A MAMMOGRAM. NEXT
SLIDE, PLEASE.
FINALLY, THERE ARE OPPORTUNITIES
IN TREATMENT FOR BREAST CANCER
INCLUDING INCREASE IN UPTAKE
ADHERENCE TO HORMONE AND
CHEMOTHERAPY.
NEXT SLIDE, PLEASE.
-- THERE ARE DOCUMENTED
DISPARITIES AND ACCESS IN
TIMELINESS IN TREATMENT AND
EFFORTS INCREASING UPTAKE AND
ADHERENCE SHOULD DECREASE BREAST
CANCER MORTALITY. NEXTLE SLIDE,
PLEASE.
PROSTATE CANCER HAS COMPLICATED
PATTERNS THAT ARE IN THE MOST
RECENT THAT IS FROM 2014 TO
2019, I SHOULD SAY INCIDENT
RATES OF PROSTATE CANCER
INCREASED THAT IS UNCLEAR
WHETHER OR NOT IT IS RELATED TO
CHANGES IN PSA TESTING
GUIDELINES SURVIVAL REMAINS
QUITE HIGH.
NEXT SLIDE, PLEASE.
MORTALITY RATES AFTER VERY
STRONG DECLINES HAVE FLATTENED
OUT IN RECENT YEARS BETWEEN 2013
TO 2019 AND WAS NONSTATISTICALLY
SIGNIFICANT DECLINE IN PROSTATE
CANCER MORTALITY RATES.
NEXT SLIDE, PLEASE.
AS I SAID, SOME CHANGES IN
INCIDENTS MAY BE RELATED TO
GUIDELINES FOR PSA TESTING. IN
2012, USPSTF RECOMMENDED AGAINST
SCREENING FOR PROSTATE CANCER
AND SWITCHED OPINION TO SHARED
DECISION MAKING IN 2018 STUD JIZ
HAVE SHOWN INCREASES IN
METASTATIC PROSTATE CANCER
DIAGNOSIS SINCE 1220 AND ALSO
LOCALIZED REGIONAL DISEASE SINCE
2014 CAUSE IS UNCLEAR AND SHIFT
AWAY FROM SCREENING IS RELATED
INCREASE IN MORE AGGRESSIVE
PROSTATE CANCERS RISK
STRATIFICATION OF SENSITIVE AND
SPECIFIC TASKS FOR HIGH-RISK
DISEASE COULD IMPROVE RISK FOR
BENEFIT FOR PSA TESTING.
NEXT SLIDE, PLEASE.
ANOTHER -- SO, EVALUATING RISK
STRATIFIED PSA SCREENING
IMPROVING DIAGNOSTIC TESTING
COULD REDUCE MORTALITY FROM
PROSTATE CANCER AS WE JUST
DESCRIBED.
NEXT SLIDE, PLEASE.
EVALUATING STRATEGIES TO FURTHER
REDUCE OVERTREATMENT AND REDUCE
DISPARITIES FOR TREATMENT AND
PROSTATE CANCER COULD REDUCE
MORTALITY.
NEXT SLIDE, PLEASE.
FINAL CANCER THAT WE FOCUSED ON
WAS LIVER AND INTRAHEPATIC BILE
DUCT CANCERS AND INCIDENTS AFTER
YEARS OF INCREASE STARTED TO
DECLINE STARTING IN 2015 AND
SURVIVAL FOR 3 AND 5 YEAR
SURVIVAL IMPROVED ALSO OVER THIS
TIME PERIOD AND SURVIVAL REMAINS
QUITE POOR.
NEXT SLIDE, PLEASE.
BETWEEN 2016 AND 2019,
NONSIGNIFICANT DECLINE IN LIVER
CANCER MORTALITY. AGAIN, AFTER
YEARS OF INCREASES IN MORTALITY
DUE TO LIVER CANCER.
NEXT SLIDE, PLEASE.
I WANT TO POINT OUT THAT IF YOU
ONLY CONSIDER LIVER CANCER THAT
IS MAJORITY OF THE CASES IN THE
GROUP THAT I SHOWED YOU, THERE
IS ACTUALLY SIGNIFICANT DECLINE
OF 1.8% A YEAR IN LIVER CANCER
MORTALITY THAT GIVES HOPE WE ARE
HEADED IN RIGHT DIRECTION WITH
LIVER CANCER DEATHS.
NEXT SLIDE, PLEASE.
ONE OPPORTUNITY FOR REDUCING
LIVER CANCER MORTALITY IS
REDUCING INCIDENCE THROUGH
INCREASING UPTAKE OF HBV AND HCV
TREATMENTS DECREASING SMOKING
PREVALENCE.
NEXT SLIDE, PLEASE.
LIVER CANCER IS INTERESTING IN
THAT IT HAS MANY DIFFERENT MAJOR
CAUSES AND ESTIMATED EXCESS BODY
WEIGHT CAUSES 1/3 OF LIVER
CANCERS ALCOHOL INTAKE 20%.
SMOKING IS 22% AND HEPATITIS B
VIRUS IN US IS 7% AND ABOUT
BETWEEN 1.5 AND 2.4 MILLION
PEOPLE WITH HEPATITIS B IN US
AND HEPATITIS C VIRUS 21% OF
LIVER CANCERS AND AGAIN FRACTION
OR NUMBER OF PEOPLE IN THE US
WITH CHRONIC HEPATITIS C VIRUS
IS BETWEEN 2.5 AND 4.7 MILLION.
NEXT SLIDE, PLEASE.
AGAIN EMPHASIZING IMPORTANCE
MAKING PROGRESS OF EXCESS BODY
WEIGHT AND ALCOHOL INTAKE AND
ESPECIALLY WITH LIVER CANCER. I
WILL FOCUS ON HEPATITIS B AND C
HERE. NEXT SLIDE, PLEASE.
NEXT SLIDE AGAIN, PLEASE.
SO, FOR HEPATITIS B VIRUS, THERE
IS INFANT VACCINATION IN US
STARTING IN 1991.
THERE IS TREATMENTS THOUGH THEY
ARE NOT CURATIVE FOR CHRONIC HBV
THAT DO REDUCE LIVER CANCER
RATES. HEPATITIS C VIRUS THERE
IS NO VACCINATION. HOWEVER,
DIRECT ACTING ANTIVIRAL AGENTS
ARE INTRODUCED IN 2014 AND ARE
CURATIVE INCREASED HBV AND HCV
TESTING IN TREATMENT ARE NEEDED
AND COULD MAKE A BIG IMPACT ON
LIVER CANCER INCIDENTS AND
MORTALITY AND HOWEVER LIKE WITH
MANY INTERVENTIONS THAT I HAVE
SHOWN YOU TODAY, DIRECT ACTING
ANTIVIRAL AGENTS THERE ARE HUGE
DISPARITIES AND ACCESS TO DRUGS
FOR TREATING CHRONIC HCV AND AGE
STRATIFIED FIGURE SHOWS
PERCENTAGE OF THOSE WITH HCV
INITIATING THESE TREATMENTS AND
HAS SHOWN THAT FRACTION OF
INDIVIDUALS WITH PRIVATE
INSURANCE WHO RECEIVE THESE
TREATMENTS IS MUCH HIGHER THAN
THOSE WITH MEDICAID.
IN ADDITION, I WANT TO POINT OUT
IN THE FIGURE THAT IN BEST CASE
SCENARIO 50 TO 59 YEAR OLDS WITH
PRIVATE INSURANCE, 40% OF
INDIVIDUALS WERE RECEIVING THIS
TREATMENT AND IS REALLY
OPPORTUNITY TO EXPAND ACCESS.
NEXT SLIDE, PLEASE.
I ALSO WANT TO POINT OUT THAT WE
THINK THAT WE ARE STARTING TO
SEE BENEFITS OF HCV TREATMENT
AND HBV TREATMENT ON LIVER
CANCER INCIDENTS BECAUSE OF A
SHARP DECLINE IN INTEREST SINCE
2019 NEXT SLIDE, PLEASE.
IN TERMS OF PREVENTING DEATHS
AMONGST THOSE WITH LIVER CANCER,
THERE IS NO POPULATION-BASED
SCREENING.
NEXT SLIDE, PLEASE.
BUT, SURVEILLANCE OF PEOPLE WITH
SOROSIS WHICH IS A CONDITION OF
THE LIVER THAT PRECEDES 80% OF
LIVER CANCERS IS RECOMMENDED
INCLUDING ULTRA SOUND WITH OR
WITHOUT ALPHA PROTEIN
MEASUREMENTS ASSOCIATED WITH
INCREASED ODDS OF HAVING
TRANSLATE ELIGIBLE TUMOR AND
IMPORTANT TO KNOW THAT 69% OF
INDIVIDUALS IN THE US WITH
SOROSIS ARE URN AWARE OF THEIR
DIAGNOSIS.
NEXT SLIDE, PLEASE.
NEXT LEADING CAUSES OF CANCER
DEATH ARE LISTED HERE. NEXT 9
AND THE APC LISTED HERE IS AN
ACRONYM FOR ANNUAL PERCENT
CHANGED AND WHAT IS ANNUAL
REDUCTION OR INCREASE IN
MORTALITY RATES FOR CANCERS THAT
YOU CAN SEE THAT FOR LEUKEMIA
AND NON-HODGE KINES LYMPHOMA
URINARY BLADDER ESOPHAGUS AND
KIDNEY OVARY MYELOMA UTERINE
CORPUS WE NEED EXCITATORY
PROGRESS AND FOR BRAIN TUMORS
AND CENTRAL NERVOUS SYSTEM
TUMORS RATES HAVE NOT DECLINED
SIGNIFICANTLY AND FOR CANCERS OF
UTERIN CORPUS DEATH RATES HAVE
ACTUALLY INCREASED OVER TIME.
NEXT SLIDE, PLEASE.
I WANT TO EMPHASIZE PROGRESS IN
PREVENTION EARLY DETECTION AND
TREATMENT OF THESE AND LESS
CANCERS IS CRITICALLY IMPORTANT.
NEXT SLIDE, PLEASE.
LIMITATIONS OF STUDY THERE IS A
NUMBER OF THEM PROJECTIONS RELY
ON ASSUMPTION THAT CHAFKS WILL
CONTINUE WITH SAME RATE
FACTORING RELATIVE IMPORTANCE OF
EXPOSURES PREVENTION AND
TREATMENT AND PROJECTIONS MAY BE
TOO OPTIMISTIC IF FOR EXAMPLE
PREVALENCE OF OVERWEIGHT AND
OBESITY ACCELERATED IN COMING
YEARS AND WANT TO POINT OUT THAT
50% DECLINE IN AGE ADJUSTED
MORTALITY RATES DOESN'T
CORRESPOND TO SIMILAR DECLINE IN
NUMBER OF CANCER DEATHS DUE TO
AGING US POPULATION AND THIS 50%
DECLINE IN THE AGE ADJUSTED
MORTALITY RATE WOULD RESULT IN
DECLINE FROM 608,000 CANCER
DEATHS IN YEAR 2022 TO 573,000
CANCER DEATHS IN YEAR 2047 AND
IMPORTANT TO REMEMBER STAYING
WHERE WE ARE IN TERMS OF CANCER
DEATH RATES THERE IS INCREASE OF
300,000 CANCER DEATH RATES BY
2047.
ACCELERATED PROGRESS WILL BE
NEED TODAY REACH MOONSHOT GOAL
OF A 50% REDUCTION OF CANCER
MORTALITY RATES BY 2047 AND IN
ADDITION CONTINUED INNOVATION
SUBSTANTIAL PROGRESS TOWARDS
THIS GOAL COULD BE ACCOMPLISHED
BY INCREASING USE OF WHAT IS
ALREADY KNOWN TO PREVENT DETECT
AND TREATMENT COMMON CANCERS AND
ADDRESSING UNDERUTILIZATION OF
DISPARITIES ACCESS TO PREVENTION
MUST PLAY A CENTRAL ROLE. NEXT
SLIDE, PLEASE.
ACKNOWLEDGING CO-AUTHORS. THIS
WAS TRULY A TEAM EFFORT IN HOW
WE DID THIS ANALYSIS AND PUT
TOGETHER THIS STUDY AS WELL AS
CONTENT EXPERTS THAT REVIEWED
OUR PAPER PRIOR TO PUBLICATION.
AND THANK YOU FOR YOUR
ATTENTION.
I'M HAPPY TO ANSWER QUESTIONS.
I AM ALL WRAPPED UP IF WE WANT
TO STOP SHARING SO I CAN SEE
EVERYONE.
THERE WE GO.
SHOULD I -- IS IT OKAY IF I CALL
ON PEOPLE TO ANSWER QUESTIONS?
I WILL DO IT. KRISTEN, SORRY I
DON'T KNOW ANYBODY'S TITLES. IF
YOU DON'T MIND FIRST NAMES THAT
IS WHAT I CAN SEE.
>>NO PROBLEM.
>>ANNIE MIGHT HAVE TECHNICAL
DIFFICULTIES.
I DON'T SEE HER. NO YOU THAT WE
HAVE EVERYBODY'S FACE UP, I
DON'T SEE HER.
THANKS FOR JUMPING IN.
>>SURE. GO AHEAD WITH YOUR
QUESTION.
>>THANK YOU. KRISTEN WITH
LONGEVITY FOUNDATION AND THIS IS
A LONG SPECIFIC QUESTION AND I
KIND OF KNOW THE ANSWER BUT WHEN
LOOKING AT RISK FACTORS ARE YOU
CONSIDER AT ALL OR IS ON RADAR I
DON'T KNOW DATA IS THERE
ENVIRONMENTAL FACTORS THAT, YOU
KNOW, FOREST FIRE SMOKE OR RADON
OR BURN PIT OR OTHER THINGS THAT
I DON'T -- I DON'T THINK THAT
THERE IS HARD DATA YET TO MAKE
THE CORRELATION BUT IS THAT
ANYTHING YOU ARE ALL CONSIDERING
OR THAT IS BEING CONSIDERED?
>>WE DON'T REALLY -- WE REALLY
FOCUSED ON MAJOR RISK FACTORS
AND MAJOR SCREENING STRATEGIES
AND TREATMENT AND THINGS THAT
WILL HAVE REALLY BIG EFFECTS AND
WHILE ALL OF THOSE ARE REALLY
IMPORTANT RISK FACTORS FOR LUNG
CANCER, THEY DON'T COME CLOSE TO
RISK ASSOCIATED AT A POPULATION
LEVEL WITH CIGARETTE SMOKING AND
WE FOCUSED REALLY ON CIGARETTE
SMOKING AND LOTS OF THOSE
PARTICULARLY THE FOREST FIRE
QUESTIONS AND IT REALLY IS HARD
TO QUANTIFY IN THE MOMENT.
OF COURSE, ALL OF THOSE THINGS
ARE REALLY IMPORTANT.
WE FOCUSED REALLY ON MAJOR RISK
FACTORS HERE.
>>JUST LIKE -- I KNOW. IT IS
KIND OF I ASSUME THAT WAS THE
ANSWER AND I HAVE COLLEAGUES IN
CALIFORNIA THAT ARE NOT EXCITED
BUT KIND OF EXCITED THAT THE
EAST COAST WAS EXPERIENCING SOME
AIR QUALITY ISSUES THAT IS MAYBE
HIGHER ON THE RADAR FOR, YOU
KNOW, CHANGES IN THE FUTURE.
>> THAT IS GREAT. OF COURSE.
>>THANK YOU.
>>THANK YOU FOR THE QUESTION.
>>SORRY I DROPPED OFF, FOLKS.
I HAD AN INTERNET HICCUP HERE.
NICOLE, SEE YOUR HAND IS RAISED.
>>YES. HI, ANNIE. WELCOME
BACK.
I HAD A COUPLE QUESTIONS.
>>SURE.
>>FIRST ONE I THINK FOLLOWS UP
ON WHAT KRISTEN WAS TALKING
ABOUT WITH ENVIRONMENTAL FACTORS
AND YOU TALKING ABOUT SMOKING
CESSATION AS BEING A MAJOR FOCUS
FOR LUNG CANCER.
DO WE KNOW WHAT THE
IMPLICATIONS WILL BE OF THE
ECIGARETTES OR VAPING THAT, YOU
KNOW, MORE YOUNG ADULTS ARE
DOING NOW?
AND HOW THAT WOULD CONTRIBUTE TO
CANCER? IF THERE SHOULD BE SOME
OPPORTUNITY THERE TO TRY TO
REDUCE AS WELL THAT AREA?
>>YEAH. I DON'T THINK --
AGAIN, I DON'T THINK THAT DATA
IS QUITE THERE YET.
UNFORTUNATELY, WITH STUDYING
CANCER AS ALL OF YOU KNOW, IT
OFTEN TAKES MANY, MANY YEARS TO
SEE IN EFFECT.
I DON'T THINK DATA FOR THOSE
PRODUCTS ARE QUITE THERE YET.
I THINK IT IS UNLIKELY THAT THEY
ARE AT THE SAME LEVEL AS
CIGARETTE SMOKING JUST BASED ON
THE FACT THAT YOU ARE INHALING A
BURNING PRODUCT INTO YOUR LUNGS
OPPOSED TO SOME OTHER PRODUCUCT
AND DATA IS NOT THERE YET AND WE
CAN'T SAY MUCH ABOUT THEM AND
INTERESTING QUESTION TOO. IT IS
POSSIBLE THAT INCREASED USE TO
SOME NONCOMBUSTIBLE PRODUCTS IS
DECREASING USE OF TRADITIONAL
CIGARETTES THAT IS SORT OF AN
INTERESTING POPULATION LEVEL
QUESTION ABOUT WHAT IS THE NET
HARM VERSUS BENEFIT.
I HAPPENED -- MY HUSBAND IS AN
EPIDEMIOLOGISTS IN CENTER FOR
TOBACCO PRODUCTS AND FDA AND
WHAT THEY ARE CONSTANT WILL I
TRYING OR STRUGGLING WITH AND
TRYING TO UNDERSTAND HOW THESE
KIND OF PRODUCTS AS ONE GOES UP
AND ONE GOES DOWN WHAT NET HARM
OR BENEFIT IS OF USE OF
PRODUCTS.
>>UH-HUH. YEAH. IT WILL BE
INTERESTING WHEN WE KNOW MORE
AND HAVE MORE DATA, LONGER TERM
DATA.
>>YEAH.
>>OTHER QUESTION I HAD WAS
AROUND MET AFT ACYST.
IT WASN'T MENTIONED AND THERE IS
AN OPPORTUNITY THERE AND YOU
KNOW MOST DEATHS FROM CANCER ARE
FROM MET AFT CYST AND NOT FROM
PRIMARY TUMOR ITSELF AND IS
THERE OPPORTUNITY THERE FOR
INCREASED SCREENING?
WE HAVE ACTUALLY TREATMENTS THAT
COULD BENEFIT PATIENTS IF MET
AFT AKRIZ ARE DETECTED EARLIER
AND IS THERE DISCUSSION ABOUT
THAT MAKING THIS IMPACT?
>>REALLY INTERESTING QUESTION
AND OUTSIDE OF MY AREA OF
EXPERTISE AND I WILL TELL YOU I
HAVE GIVEN THIS PRESENTATION
MANY TIMES AND NOBODY HAS ASKED
ME THAT.
I WILL WRITE IT DOWN AND LOOK
MORE INTO IT.
I THIS I IT IS A REALLY
IMPORTANT QUESTION.
I WILL TELL YOU MY EXPERTISE IS
IN SURVEILLANCE RESEARCH.
I -- YOU KNOW, THAT IS WHAT I --
THAT IS WHAT MY SCIENCE IS ON
UNFORTUNATELY CANCER REGISTRIES
DON'T -- THEY COLLECT MET
AFTCIES AT DIAGNOSIS.
THEY DON'T -- THERE IS NOT
FOLLOW UP FOR -- DATA IS NOT
COLLECTED THAT REOCCURRENCE DATA
IS NOT COLLECTED AND IS A MAJOR
GAP THAT WE CAN'T SEE WHAT IS
HAPPENING THERE AT A POPULATION
LEVEL THAT IS A MAJOR LIMITATION
OF OUR SURVEILLANCE SYSTEM.
>>ALL RIGHT. THANK YOU.
>>THANK YOU, NICOLE. MARTY, I
SEE YOUR HAND IS UP.
>>YES. THANK YOU.
SO, MY AREA OF KNOWLEDGE IS
PROSTATE CANCER AND QUESTION
APPLIES TO BROAD RANGE OF
CANCERS MENTIONED CESSATION OF
SMOKING REDUCING ALCOHOL AND
COUPLE OF FACTORS ARE IMPORTANT
BY, YOU KNOW, REDUCING BAD
THINGS THAT WE PUT IN OUR BODIES
AND ON MORE POSITIVE NOTE I READ
A LOT OF STUDIES THAT SHOWED
THAT A HEALTHY DIET AND EXERCISE
PROGRAM AND THAT KIND OF THING
ACTUALLY HAS A DOCUMENTED
PREVENTIVE BENEFIT IN TERMS OF
PROSTATE CANCER THAT ADVANCES.
IS THAT TOO TANGENTIAL?
IS THAT SOMETHING YOU ARE
LOOKING AT?
>>WE CONSIDERED THAT KIND OF
LIKE THE POSITIVE SPIN AND
PHYSICAL ACTIVITY AND HEALTHY
DIET AND OPPOSITE THAT IS THE
OBESITY RATES.
WE STRUGGLED A LOT IN ANALYSIS
WITH HOW TO ADDRESS THOSE.
THEY ARE QUITE DIFFICULT TO
ADDRESS AT A POPULATION LEVEL.
THERE, YOU KNOW, THERE ARE NOT
-- YOU KNOW, WITH CIGARETTES
THERE WAS REGULATION; RIGHT?
BY FDA AND INDOOR SMOKING LAWS
AND LOTS OF THINGS THAT HAPPENED
WITH SMOKING THAT HELPED REDUCE
THE PREVALENCE OF SMOKING.
WITH OBESITY AND PHYSICAL
ACTIVITY AND HEALTHY EATING IT
HAS BEEN A REAL CHALLENGE AT A
POPULATION LEVEL TO SEE PROGRESS
YOU SEE UNFORTUNATELY IN OBESITY
RATES AND PHYSICAL RATES HAVEN'T
IMPROVED EITHER AND WE DIDN'T
WANT TO SAY THERE IS NO WAY
THERE COULD BE PROGRESS ON
FACTORS THAT ARE REALLY
IMPORTANT.
I DON'T HAVE A PARTICULAR
INTERVENTION TO TELL YOU WE
SHOULD ACCELERATE ON THIS
INTERVENTION TO BE ABLE TO MAKE
CHANGE AT A POPULATION LEVEL AND
REALLY HOPE THAT IT HAPPENS BUT
CAN'T TELL WHAT YOU IT LOOKS
LIKE RIGHT NOW. TO YOUR POINT
AT AN INDIVIDUAL LEVEL, YES.
PHYSICAL ACTIVITY AND HEALTHY
EATING MAKES A DIFFERENCE TO
ONE'S INDIVIDUAL RISK.
>>THANK YOU.
>>THANK YOU, MARTY. NATHANIEL?
>>GREAT RESEARCH AND LOVE IT
AND COMMENT WILL BE SHORT AND IT
PIGGYBACKS OFF MY PEERS COMMENTS
IN JUST THAT I HOPE THAT MAYBE
AS YOU LOOK FURTHER IN YOUR
RE-ENVIRONMENTAL THINGS THAT MAY
-- THEY MAY BE OF MORE
PREVALENCE THAT I KNOW IS COMING
UP AND SEEMS MUCH MORE
FREQUENTLY LATELY AS WE THINK
ABOUT THINGS WE HAVEN'T THOUGHT
ABOUT BEFORE.
I WOULD LIKE TO POINT OUT
PARTICULARLY RADON THAT I THINK
IS A QUANTIFIABLE THING YOU CAN
GET HARD DATA ON PARTICULARLY
IN, YOU KNOW, STATES LIKE I
THINK WASHINGTON, CALIFORNIA AND
UTAH HAVE LOWEST RATES OF
SMOKING BUT HAVEN'T ERADICATED
LUNG CANCER AND CONSEQUENTIALLY
HAVE HIGHEST RATES OF RADON AND
INTERESTING THINGS THERE IN
NORTHWEST REGIONS WITH RADON AND
ENCOURAGE THAT IN FUTURE STUDIES
AND REALLY WOULD LOVE TO SEE
STATISTICALLY THIS. I THIS I IT
IS A GREAT -- IT IS A GREAT
HEADING AND CHALLENGE YOU ARE
GOING ON AND IS THIS FEASIBLE
AND THAT IS THE QUESTION THAT WE
LOVE TO SEE BH THERE IS A BIG
GOAL REDUCING CANCER BY 50%.
>>RIGHT.
>>I APPRECIATE REALLY PUTTING
QUANTIFIABLE MEASURES TO IT AND
HOPE WE CAN CONTINUE TO EXPAND
THAT.
>>THANK YOU FOR YOUR COMMENT.
I AGREE THAT ENVIRONMENTAL
EXPOSURES ARE REALLY IMPORTANT
AND DIVISION I SIT IN AT NC
INTRA MURAL DIVISION HAS A WHOLE
BRANCH FOCUSED ON OCCUPATIONAL
AND ENVIRONMENTAL EXPOSURES
WATER AND AIR POLLUTION AND ALSO
OCCUPATIONAL EXPOSURES AND
RESEARCH IN AREA AND PFAS AND
EXPOSURE AND THINGS YOU HEAR.
WE AT INTRAMURAL PROGRAM AT NCI
IS NOT FOCUSED ON THAT OR MY
RESEARCH SPECIFICALLY.
>>THANK YOU, NATHANIEL.
I APOLOGIZE FOR MY WI-FI
DROPPING LAST FEW MINUTES OF
YOUR TALK IN THE LAST QUESTION.
I APPRECIATE SO MUCH OF WORK
THAT YOUR TEAM PUT INTO THIS AND
TO REALLY LOOK AT WHAT IT WOULD
TAKE TO MOVE THE NEEDLE IN THE
RIGHT DIRECTION HERE AS WELL AS
DIRECTION THAT THINGS ARE GOING.
AND I APPRECIATE THAT YOU ARE
LOOKING AT, YOU KNOW, ALSO
REDUCIN KRIDIENTS ALONG WITH
MORTALITY AND NOT FOCUSING ON
MORTALITY INCIDENTS IF YOU
REDUCE YOU REDUCE MORTALITY IN
LOTS OF THESE CASES AND TWO
QUICK QUESTIONS THAT WE DON'T
PROBABLY HAVE TIME FOR BOTH OF
THEM.
I WILL THROW THEM OUT THERE.
YOU CAN CHOOSE WHAT YOU WANT TO
FROM THE LAST FEW MINUTES AND
FIRST, YOU KNOW, IS THERE GOING
TO BE A FOLLOW UP STUDY TO
UNDERSTAND HOW WE CAN PROBABLY
MAKE PROGRESS AGAINST UNCOMMON
CANCERS AND SECOND QUESTION IS A
LITTLE BIT THAT WE HEAR -- I
HAVE HEARD IN SOME SPACES ABOUT
REDUCING MORTALITY BY 50 P RS IF
WE JUST GET STANDARD OF CARE TO
LIKE THE AREAS OF PERSISTENT
POVERTY WHERE THAT IS NOT
HAPPENING AND IS THERE A WAY TO
SHOW THAT OR PROVE IT OR DO IT
P.
AND, YOU KNOW.
>>YEAH. I WILL TAKE THE SECOND
ONE.
YOU PEEKED MY INTEREST THERE I'M
REALLY INTERESTED IN THAT.
NUMERICALLY, WE COULD TRY TO
FIGURE OUT SOME WAY OF LIKE
THESE ARE THE AREAS OF THE
COUNTRY WITH THE BEST MORTALITY
RATES.
IF EVERYBODY HAD THE BEST
MORTALITY RATES, WHERE WILL WE
BE?
SOMETHING OF THAT MAYBE
SOMETHING A LITTLE MORE NUANCED
IN THAT WAY AND SOMETHING THAT
COLLEAGUES AND I ARE THINKING
ABOUT.
AS I SHOWED AND AS YOU ARE VERY
AWARE AT EVERY INTERVENTION
POINT THERE ARE PROFOUND
DISPARITIES IN ALL SORTS OF
METRICS OF DISADVANTAGE.
AND IF WE COULD GET THINGS THAT
WORKED AND PEOPLE NOT RECEIVING
THEM WE COULD MAKE TREMENDOUS
PROGRESS.
>>THANK YOU SO MUCH.
I'M GLAD YOU ARE THINKING ABOUT
THAT AND THANKS SO MUCH FOR YOUR
WORK AND THANK COLLEAGUES FOR
WONDERFUL DIALOGUE AND QUESTIONS
AND AT THIS POINT, WE CAN HAVE
-- WE ARE SLATED TO HAVE A
BREAK. IT WAS GOING TO BE 15
MINUTES BUT WE ARE NOW DOWN TO
10.
SO, IF EVERYBODY -- AMY, IS IT
OKAY IF WE COME BACK AT 2:15?
>>YEAH. 2:15 SOUNDS GOOD. DR.
PRINDIVILLE WILL JOIN US THEN.
>>FANTASTIC. THANK YOU DR.
SHIELS.
>>THANK YOU.
>>CALLING THE MEETING BACK TO
ORDER. AT THIS TIME WELCOMING
SHEILA PRINDIVILLE. I AM SO
EXCITED TO HEAR YOUR OVERVIEW OF
CLINICAL TRIALS INNOVATION UNIT.
THANK YOU FOR JOINING US TODAY.
>>TERRIFIC.
THANK YOU ALL. WE CAN GO TO THE
NEXT SLIDE.
I REALLY THANK YOU FOR THE
OPPORTUNITY TO SPEAK WITH YOU
TODAY AND TO ACTUALLY GET YOUR
FEEDBACK AND INPUT ON THE TOP
CLINICAL TRIALS INNOVATION UNIT.
IN MY PRESENTATION TODAY THOUGH,
I WANT TO FIRST PROVIDE YOU WITH
AN OVERVIEW OF NCI'S STRATEGIC
VISION FOR CLINICAL TRIALS THAT
WILL PROVIDE CONTEXT FOR THE
INFORMATION THAT I WILL PRESENT
ON THE CLINICAL TRIALS
INNOVATION UNIT THAT IS A NEW
INITIATIVE THAT IS LAUNCHED
EARLIER THIS YEAR UNDER DR.
[INDISCERNIBLE]'S LEADERSHIP.
NEXT SLIDE, PLEASE.
MANY OF YOU REALLY KNOW AND HAVE
EXPERIENCED FIRSTHAND THAT MANY
OF OUR CANCER CLINICAL TRIALS
ARE COMPLEX AND EXPENSIVE
STUDIES THAT CAN BE SLOW AND
CUMBERSOME AND HAVE A SLOW
ACTIVATION PROCESS THAT CAN THEN
RESULT IN DELAYING RESULTS IN
GETTING THEM OUT IN A TIMELY
FASHION THAT IS OFTEN OVERLY
BURDENED DESIGNS AND INEQUITABLE
ACCESS TO SOME STUDIES AND OFTEN
DATA COLLECTION COULD BE IN
EXCESS OF WHAT IS ACTUALLY USED
AT THE END OF THE DAY AND WE
KNOW COLLECTIVE WILL I THAT SOME
AILMENTS THAT ARE EFFECTING SOME
TRIALS HAS RESULTED IN A MODEL
THAT COULD BE UNSUSTAINABLE FOR
THE LONG TERM.
NEXT SLIDE, PLEASE.
SO, TO ADDRESS SOME OF THE
CHALLENGES I JUST DESCRIBED, NCI
FORMED A STRATEGIC PLANNING
WORKING GROUP UNDEROS PISSIES
UNDER THE RESEARCH ADVISORY
COMMITTEE AND THAT COMMITTEE IS
KNOWN AS CTAC. YOU HAVE HEARD
OF THAT IN THE PAST.
WA WE REALLY THIS GROUP IS
CHALLENGED TO ASSESS NCI'S
STRATEGIC VISION FOR CLINICAL
TRIALS FOR 2030 AND BEYOND AND
THEY DID THAT AND DEVELOPED 15
RECOMMENDATIONS FOR WHICH THEY
FOLLOW THEMES ON THIS SLIDE AND
MANY ADDRESS TRIAL COMPLEXITY
AND DECENTRALIZING TRIALS AND
OPERATIONAL NEW BURDEN AND NEW
DATA COLLECTION APPROACHES AND
IF INTERESTED IN THIS I WANT TO
CALL THOSE OUT AND THIS IS ON
THE CTAC WEBSITE AND FULL LINK
IN THE REPORT IS HERE ON THE
SLIDE.
LISTING OUT A LOT OF DIFFERENT
APPROACHES THAT WE ARE ACTIVELY
IMPLEMENTING THIS AT NCI.
NEXT SLIDE, PLEASE.
BUT, THE STRATEGIC VISION THAT
THE WORKING GROUP AND NCI CAME
TO REALLY IS TO FOCUS ON
DEVELOPING FLEXIBLE FASTER AND
SIMPLER AND LESS EXPENSIVE HIGH
IMPACT CLINICAL TRIALS THAT
SEAMLESSLY INTEGRATE IN CLINICAL
PRACTICE AND SOME
RECOMMENDATIONS OUT OF THAT
REPORT THAT ARE KEY IS THAT WE
NEED TO STREAMLINE PROCESSES FOR
TRIAL DESIGN AND EXECUTION.
FOCUS ON THE ESSENTIAL ENDPOINTS
AND DECREASE REGULATORY HURDLES
AND ARE -- AND ARE BROADENED
TRIAL ACCESS AND INCREASE
EFFICIENCY OF DATA COLLECTION.
NEXT SLIDE. EXAMPLES OF
ACTIVITY NCI THAT HAS LAUNCHED
TOWARDS ACHIEVING THIS VISION
ARE LISTED ON THE SLIDE. LAST
MEETING [INDISCERNIBLE] CAME AND
TALKED TO YOU ABOUT EFFORTS
CREATING STANDARDS FOR LIMITING
DATA COLLECTION AND IMD EXEMPT
TRIALS AND WE TALK YOU TO ABOUT
THE FACT WE ARE ADOPTING LOCAL
AND REMOTE STUDY PROCEDURES THAT
WE PUT IN PLACE DURING THE
PANDEMIC AND WE ARE MAKING SOME
OF THOSE PERMANENT AS MUCH AS
POSSIBLE TO PROMOTE
DECENTRALIZED TRIALS AND
BRINGING TRIALS TO MEET PATIENTS
WHERE THEY ARE AND WORKING ON
EFFORTS TO INCREASE PATIENT
ACCESS TO TRIALS INCLUDING
BROADENING PATIENT ELIGIBILITY
AND PROGRAM TO CONNECT
UNDER-REPRESENTED POPULATION
TRIALS PARTICULARLY NCNN AND
[INDISCERNIBLE] TRIALS AND
ACTIONS DR. DORIS SPOKE TO YOU
ABOUT AT LAST MEETING WE ARE
ACTIVELY WORKING ON IMPLEMENTING
AND, YOU KNOW, THEY ARE REALLY
IMPORTANT TO MODERNIZING
CLINICAL TRIALS SYSTEM AND DR.
BURTON ELLI WHEN ARRIVED SHH IS
HE CHALLENGE THE US TO THINK
OUTSIDE OF THE BOX ABOUT
ADDITIONAL ACTIONS THAT COULD BE
TAKEN TO HELP TRANSFORM AND
MODERNIZE OUR CLINICAL TRIALS
SYSTEM.
AND SO SOMETHING THAT HAS COME
OUT OF THAT IS LAUNCHING OF
CLINICAL TRIALS INNOVATION UNIT.
THE NEED FOR THIS IS REALLY THAT
WE FELT THAT TO RADICALLY
TRANSFORM HOW CLINICAL TRIALS
ARE CONDUCTED, WE NEEDED A NEW
PLATFORM TO DO THAT.
WE WANTED TO BE ABLE TO RAPIDLY
IDENTIFY AND TEST MOST
INNOVATIVE APPROACHES AND DIDN'T
WANT TO CAUSE DISRUPTION TO
CURRENT SYSTEM AND PROCESSES
BUILDING CROWN JEWELS OF SYSTEM
NCTN AND N CORE AND WANTED THAT
TO BE ABLE TO CONTINUE ON AND
MAKE CHANGES THAT I ALREADY
DESCRIBED AND MAKE SURE THAT
TRIALS THAT WERE UNDERWAY WERE
NOT DISRUPTED AND WE THOUGHT
THAT CLINICAL TRIALS INNOVATION
UNIT MAY BE A PLATFORM TO HELP
US TRY MORE RADICALLY OR
INNOVATIVE ACTIONS.
NEXT SLIDE, PLEASE.
SO, THE OVERARCHING GOALS OF
CLINICAL TRIALS INNOVATION IS TO
REDUCE COMPLEXITY THROUGH NEW
MODELS OF SCIENTIFIC
PARTNERSHIPS AND COLLABORATIONS
FOR INNOVATIVE SCIENCE AND
PROMOTE EQUITABLE CLINICAL
TRIALS PARTICIPATION AND
COMPLEMENT THE NATIONAL CANCER
PLAN AND CANCER MOONSHOTS GOALS
TO WORK WITH PARTNERS IN
GOVERNMENT INDUSTRY AND ADVOCACY
AND OTHER ORGANIZATIONS TO
MODERNIZE TRIALS AND MOST
IMPORTANTLY TO BRING RESULTS TO
PATIENTS FASTER.
NEXT SLIDE, PLEASE.
JUST EXACTLY WHAT IS CTIU?
INTERAGENCY PLATFORM AND FORUM
FOR WHICH WE BRING TOGETHER THE
NCI FDA AND EXTRAMURAL CLINICAL
RESEARCH COMMUNITY TO ADVANCE
CLINICAL CARE AND EQUITABLE
TRIALS PARTICIPATION THROUGH
INNOVATIVE SCIENCE, TRIAL
DESIGNS, AND OPERATIONAL
EFFICIENCIES.
WE ENVISION THIS ONLY FOR A FEW
HIGH PRIORITY CLINICAL RESEARCH
STUDIES A YEAR; RIGHT?
ALL OTHER STUDIES WE DON'T WANT
TO DISRUPT BUT WILL TRY
POTENTIALLY NEW NOVEL WAYS TO DO
THINGS FOR A FEW STUDIES ON A
[INDISCERNIBLE] BASIS.
NEXT SLIDE.
SO, THE -- YOU KNOW, THE THING
THAT IS REALLY UNIQUE ABOUT THIS
IS THAT WE ARE TRYING TO BRING
CRITICAL LEADERSHIP OF OUR
SYSTEMS TOGETHER AT THE EARLIEST
POINT IN THE DEVELOPMENT OF A
TRIAL ALL TO THE SAME TABLE THAT
WOULD INCLUDE REPRESENTATIVES OF
FDA WHO COULD PROVIDE US
HIGH-LEVEL REGULATORY INPUT
ABOUT DESIGNS OF TRIALS THAT
COULD BE INNOVATED AND NCI THAT
WOULD PROVIDE IMPACT ABOUT IDEAS
AND FEASIBILITY AND EXTRAMURAL
COMMUNITY, RESEARCH COMMUNITY AS
WELL.
THAT PARTICULARLY I HAVE -- MY
NEXT SLIDE WILL DESCRIBE THAT.
I WANT TO POINT OUT THAT THERE
ARE TWO KEY PEOPLE THAT ARE
INCLUDING MYSELF AND I CODIRECT
THIS WITH MICHAEL MORRIS WHO IS
A MEDICAL ONKOLGS WHO HAS COME
TO NCI FROM MEMORIAL SLOAN
KETERRING ON INTERAGENCY
AGREEMENT AND WILL WORK WITH US
AND SPECIAL ADVISOR TO DR.
BURTON ELLI AS WELL AND TOGETHER
WE ARE WORKING TO LAUNCH THIS
UNIT AND FACILITATE IT WITH
COORDINATOR IRIS CASTRO.
NEXT SLIDE, PLEASE.
THE EXTRAMURAL COMMUNITY
PARTNERS AS YOU ALL KNOW INCLUDE
NCTN AND INL VEST GATORS AND
LEADERSHIP THERE AND COMMUNITY
ONCOLOGY AND N CORE AND INDUSTRY
IS IMPORTANT COMPONENT OF ALL
THIS AND ADVOCACY AND REASON I
HAVE NCTN IN BLUE IS AS WE HAVE
STARTED TO LAUNCH THIS IN OUR
INITIAL PILOT PHASE HERE WE ARE
WORKING CLOSELY WITH NCTN.
WE HAVE NOT YET BROADENED OUR
PARTNERS AND N CORE INDUSTRY AND
FULLY WITH ADVOCACY AND ADVOCACY
OF COURSE IS AN IMPORTANT PART
OF ANY RESEARCH THAT WE DO.
WE HAVE ACTUALLY STARTED THIS
OUT WITH NCTN.
WE -- BASED ON OUR EXPERIENCE AS
WE LEARN AND FINE TUNE THINGS AS
WE EXPECT TO BE BRINGING IN N
CORE INDUSTRY AND FULLY BRINGING
ADVOCACY INTO THIS PROGRAM.
NEXT SLIDE, PLEASE.
WHAT DO WE ENVISION DELIVERABLES
FOR THIS WOULD BE?
WE ARE TRYING TO DEVELOP
IMPACTFUL AND TRANSFORMATIVE
THAT COULD BE THERAPEUTIC
AGENTS, PREVENTIVE STRATEGIES OR
IMAGING AND BIOLOGICAL MARKERS
AND WANT TO PRODUCE HIGH-IXPACT
ACTIONABLE RESULTS, STREAMLINED
TRIAL DESIGNS AND DATA
COLLECTIONS AND ARE TYPES OF
THINGS TO BE RAPIDLY CONDUCTING
INNOVATIVE STUDIES IN OUR
EXISTING NCI NETWORKS THAT IS
IMPORTANT TO POINT OUT THAT WE
ARE NOT FORMING A NEW NETWORK
AND WAY OF BRINGING PEOPLE
TOGETHER TO SELECT A FEW HIGH
PRIORITY TRIALS TO BE CONDUCTED
WITHIN NETWORK AND NO NEW
INFRASTRUCTURE AND WOULD BE TO
LAUNCH TRIALS WITHIN NCTN OR N
CORE OR OTHER EXISTING NETWORKS.
NEXT SLIDE, PLEASE.
WHAT TYPES OF STUDIES ARE WE
LOOKING AT?
WHAT IS TRULY INNOVATIVE?
THIS IS THE BIG QUESTION. WHAT
IS A REALLY INNOVATIVE STUDY;
RIGHT?
BIG PART OF WHAT OUR DISCUSSIONS
ARE AS WE LAUNCH THIS AMONGST
GROUPS PART OF THIS IS WE ARE
TRYING TO REALLY DEFINE WHAT
MAKES AN INNOVATIVE STUDY AND WE
ARE THINKING THESE ARE STUDIES
THAT WOULD BREAK THE MOLD DOING
THINGS DIFFERENTLY AND NOT JUST
-- WE WANT INTERVENTIONS THAT
WOULD NOT JUST BE NOT
INCREMENTALLY ALTERING STANDARDS
OF CARE AND WANT SOMETHING THAT
WOULD BE BOLD AND ACTUALLY
MAKING A CHANGE AND COULD BE
BIOMARKERS DRAMATICALLY
SHORTENING TRIALEND POINTS AND
WOULD HAVE TO BE THINGS OF
COURSE THAT ARE FULL WILL I
VALIDATED EXPECT OCCURRING IN
LATE PHASE STUDIES NOT EARLY
PHASE STUDIES AND LOOKING ATTIES
THAT COULD LOOK NOVEL WAYS TRIAL
OPERATIONS AND NEW WAYS TO
EXTRACT DATA FOR EXAMPLE FROM
ELECTRONIC HEALTH REPORTS AND
THINGS THAT ARE NOVEL WAYS OF
COLLABORATING AMONGST VARIOUS
ENL TITTIES AND STAKEHOLDERS AND
BUILT INTO ALL THIS IS WE ARE
ANTICIPATING WE WANT TRIALS TO
BE LAUNCHED RAPIDLY AND QUICKLY
SO THERE WOULD BE NOT -- THERE
WOULD BE RAPID EVALUATION
APPROVAL AND ACTIVATION SUCH
THAT THINGS WOULD HOPEFULLY BE
FROM THE TIME ONSET TO LAUNCH,
YOU KNOW, IN LESS THAN A YEAR.
NEXT SLIDE, PLEASE.
SO, AN EXAMPLE FOR US AS I THINK
YOU HAVE HEARD ABOUT THIS IS
THAT, YOU KNOW, IS THIS REAL OR
ASPIRATIONAL?
CAN THIS REALLY BE DONE?
I THINK YOU HAVE HEARD FROM --
I'M NOT SURE IF YOU HAD TO HAVE
THIS PRESENTED.
BUT, THE -- YOU KNOW, NCI
RECENTLY LAUNCHED A STREAMLINE
CLINICAL TRIAL WITH
COLLABORATION WITH FDA UNDER
SWOG THAT IS PRAGMATIC LUNG
STUDY AND IT IS TRYING TO
EVALUATE WHETHER TWO AGENTS FOR
WHICH WE KNOW A LOT ABOUT THEM
ALREADY COMBINED THERAPY THAT
CAN REALLY IMPROVE OVERALL
SURVIVAL IN PATIENTS WITH
ADVANCED LUNG CANCER AND
NONSMALL CELL LUNG CANCER.
WHAT IS IMPORTANT ABOUT THIS
TRIAL IS THAT IT REALLY IS
DESIGNED TO ELIMINATE POTENTIAL
BARRIERS TO ENROLLMENT AND
INCREASING DIVERSITY AND
ENROLLMENT IN TRIALS AND NOVEL
ABOUT THIS IS STREAMLINING
PROCESSES AND USING FOCUSED
ENDPOINTS AND EFFICIENT DATA
COLLECTION AND ANTICIPATE THIS
STUDY LAUNCHED AND ANTICIPATE
700 PARTICIPANTS ENROLLED BY
2025 AND THIS REALLY WAS THIS
IDEA THAT WE ARE COMING TOGETHER
HAVING A PRAGMATIC TRIAL AND
COLLECTING ONLY KEY ESSENTIAL
ENDPOINTS THAT ARE NEEDED AND
THIS TRIAL WAS LAUVE LAUNCH THE
VERY SHORT PERIOD OF TIME
ROUGHLY 6 MONTHS TO IDEA AT TIME
IT WAS REALLY LAUNCH THE AND
FACILITATED HAVING KEY PARTNERS
AT TABLE AS THIS TRIAL WAS
LAUNCHED.
NEXT SLIDE. ADDITIONALLY WITH
THIS TRIAL, NEXT SLIDE, I THINK
THERE IS A THING THAT GOES AND
MUST BE ANIMATED AND THANKS SO
MUCH. WHAT IS DIFFERENT ABOUT
THIS PARTICULAR TRIAL IS THAT WE
REALLY LIMITED FOCUSING ON
ESSENTIAL ENDPOINTS THAT WE KNEW
ABOUT THE TWO DRUGS THAT ARE
BEING STUDIED NO PROTOCOL
REQUIRING LABS OR SPECIMEN
COLLECTIONS AND IMPORTANTLY
ADVERSE EVENTS THAT ARE
COLLECTED ARE REALLY ALL GRADE 5
AND UNEXPECTED REPORTABLE GRADE
3 AND 4 ADVERSE EVENTS AND WHAT
IT DOES IS REALLY REDUCES BURDEN
ON STUDY SITES AS WELL AS
PATIENTS PARTICIPATING TO GET
FOCUSING ON WHAT IS KEY AND
CRITICAL THAT IS A VERY
STREAMLINED CLINICAL TRIAL.
THIS IS REALLY A EXAMPLE THAT
THIS CAN BE DONE WHEN YOU BRING
THE RIGHT PEOPLE TOGETHER
QUICKLY TO GET A TRIAL LAUNCHED.
IMPORTANTLY, THIS IS NOT
APPROPRIATE FOR EVERY TRIAL. IF
YOU HAD AN EARLY DRUG AND DIDN'T
KNOW TOXICITIES YET, YOU WOULD
NEED TO COLLECT MORE ADVERSE
EVENTS AND IN THIS SETTING, WE
DID KNOW REALLY WHAT IS GOING ON
WITH BOTH OF THE DRU DRUGS AND E
VERY MUCH ABLE TO STREAMLINE
THIS AND HOPING TO HAVE
ADDITIONAL TYPES OF TRIALS IN
THIS TYPE OF SETTING WE COULD
REALLY PRIORITIZE AS ONE MODEL
THAT MIGHTINO VATED AND TRULY
STREAMLINING WHAT WE COLLECT.
NEXT SLIDE, PLEASE.
SO, WHAT WE ARE ENVISIONING WHAT
WILL HAPPEN THAT IS ROAD MAP FOR
BEING IN NEW WAYS THINKING ABOUT
HOW TO GET TRIALS LAUNCHED
QUICKLY AND IN JUNE, WE HAD OUR
FIRST ROUND OF IDEAS THAT WERE
SUBMITTED AND IDEA HERE IS THAT
WE WANT ONE TO TWO PAGES BECAUSE
WE NEED TO QUICKLY MAKE A
DECISION.
AS YOU KNOW, CONCEPTS NOW ARE
MUCH LONGER THAN THAT AND IDEA
TO BE RAPID VETTING BY CTI UNIT
FOR SELECTION.
WE WOULD THEN TAKE ONE OR TWO
IDEAS THAT WE RAPIDLY WOULD THEN
DEVELOP INTO A PROTOCOL
COLLABORATIVELY FOR DEVELOPMENT
AND EXECUTION WITH NCI'S
NETWORK.
AS YOU SEE, THIS IS NOT
TYPICALLY WE HAVE NOW A PROCESS
WHERE THERE WILL BE CONCEPTS
THAT COME INTO OUR STEERING
COMMITTEES THAT THERE IS THEN
PROTOCOL DEVELOPMENT AND IT IS A
MUCH LONGER TIMELINE AND HOPING
BY WORKING COLLABORATIVELY FROM
THE GET-GO WE COULD DEMONSTRATE
FOR A FEW SELECT TRIALS YOU
COULD RAPIDLY LAUNCH THESE
TRIALS.
NEXT SLIDE, PLEASE.
SO, WHERE ARE WE GOING TO GET
IDEAS?
WHAT HAVE WE DONE IN THIS VERY
EARLY PILOT PHASE?
SO, WHAT I HAVE MENTIONED IS
THAT FOR THE FIRST ROUND THAT WE
HAVE LIMITED IT TO JUST NCTN.
GOAL IS TO MAKE THIS MORE
BROADLY FOR FUTURE ROUNDS AND
FIRST ROUND WE TOOK IDEAS FROM
NCTN MEMBERS AS WELL AS INDUSTRY
PARTNERS WITH NCTN THAT WERE
ABLE TO WORK WITHIN THEIR GROUPS
AND SUBMIT IDEAS TO CTI UNIT ALL
OF WHICH AS YOU SEE IS VERY
EARLY ON AND WE GOT THE FIRST
ROUND OF IDEAS FROM THE NCTN.
EACH GROUP WAS LIMITED TO GIVING
US APPROXIMATELY THREE TO FOUR
IDEAS AND GROUP IS GOING TO COME
TOGETHER AND RAPIDLY LOOK AT
IDEAS AND DECIDE AND IN PART
SELECT ONE THAT WE HOPE THAT IS
BY THE END OF JULY THAT WE
ACTUALLY WOULD BE ABLE TO SAY
THIS IS THE TRIAL THAT WE MIGHT
TAKE AND DEVELOP INTO A -- INTO
A PROTOCOL.
SO, IT IS RIGHT NOW THAT WE HAVE
LIMITED IT TO THE NCTN.
WE HOPE THAT WE WILL EXPAND UPON
THIS BASED ON WHAT WE LEARNED IN
THIS VERY INITIAL PHASE.
AS YOU KNOW, ADVOCATES ARE
INVOLVED IN NCTN GROUPS WHEN
VETTING IDEAS THAT WE WILL HAVE
AT OUR TABLE AND WHEN COMING TO
MAKE A DECISION ON THIS -- WHAT
TRIAL WE THINK COULD BE MOVED
FORWARD AND LAUNCHED WITH US.
WE WILL HAVE AN ADVOCATE AND
LIKELY ONE NOT ENGAGE THE WITH
NCTN AND AT TABLE TO TELL US
WHICH TRIALS THEY THINK WOULD
BEST BE LAUNCHED IN THIS
PROCESS.
NEXT SLIDE, PLEASE.
SO, IN SUMMARY HERE, YOU KNOW,
WHAT WE ARE ENVISIONING CLINICAL
TRIALS TO BE COLLABORATION
BETWEEN NCI AND FDA AS I
MENTIONED THAT ARE EXTRAMURAL
PARTNERS THAT WE HOPE THAT WE
WILL SELECT A FEW HIGH PRIORITY
STUDIES WITH NOVEL OR DIFFERENT
STUDY DESIGNS AND THINGS FOR
OPERATIONAL PROCEDURES TO HELP
US WITH CLINICAL TESTING TO
DELIVER NEW APPROACHES FOR
DIAGNOSIS TREATMENT AND
PREVENTION OF CANCER.
WE HOPE WE WILL GET THESE IDEAS
MORE BROADLY THAN JUST FROM THE
NCTN AS WE GO FORWARD.
WE KNOW THEY ARE IDEAS FOR OTHER
NOVEL THINGS THAT COULD BE DONE
FROM INDUSTRY PARTNERS AS WELL
AS NCOR AND COMMUNITY ONCOLOGY
UNIT AND OTHER FOUNDATIONS AND
ADVOCACY GROUPS AND NOW WE HAVE
BEEN FOCUSING ON NCTN THAT IS
INITIAL PILOT AS WE ROLL THIS
OUT TO SEE WHAT IDEAS WE GET AND
RAPIDLY USE IDEAS OF DIFFERENT
WAYS OF REVIEWING AND LAUNCHING
A TRIAL AND WITH THAT, THIS IS
SORT OF AS I MENTIONED WE ARE
VERY EARLY ON IN THIS PROCESS
THAT WAS JUST LAUNCHED AT END OF
FEBRUARY THAT HAS BEEN MOVING
VERY, VERY QUICKLY AND DELIGHTED
WE HAVE THE OPPORTUNITY TO TALK
WITH YOU HERE TODAY TO START TO
GET YOUR THOUGHTS AND FEEDBACK
ON THIS. AND WE CAN TALK
THROUGH WAYS IN WHICH WE WILL BE
-- AS THIS EVOLVES, I'M SURE I
WILL BE BACK TALKING WITH YOU AS
WE GAIN MORE EXPERIENCE WITH
THIS PROGRAM.
WITH THAT, WE CAN TAKE -- THAT
IS MY LAST SLIDE AND OTHER THAN
I WANT TO GIVE MUCH APPRECIATION
FOR LEADERSHIP FROM DR. BERT AGO
NOELI FOR US THINKING OUTSIDE OF
THE BOX AND COMING UP LAUNCHING
NEW WAYS TO DO THINGS FASTER
WHILE NOT DISRUPTING SYSTEM AND
NCI COLLEAGUES AND COLLEAGUES AT
FDA ONCOLOGY CENTER OF
EXCELLENCE AND EXTRAMURAL
PARTNERS.
IF YOU HAVE QUESTIONS, FEEL
FREE TO CONTACT ME.
OF COURSE, YOU CAN CONTACT THIS
E-MAIL ADDRESS HERE.
WE HAVE A SPECIFIC E-MAIL BOX
THAT IS SET UP FOR THE NCI
CLINICAL TRIALS INNOVATION UNIT
AND E-MAIL IS HERE ON THIS
SLIDE.
SO, WITH THAT, I THINK I WILL
PAUSE.
I WILL OPEN IT UP TO QUESTIONS.
AND I GUESS WE WILL GO FROM
THERE.
>>THANK YOU SO MUCH.
>>OKAY. TERRIFIC. HI.
>>IT IS OKAY. THANK YOU SO
MUCH DR. PRINDIVILLE FOR
EXCITING PRESENTATION ABOUT
EARLY DAYS THAT I BET MUST BE
VERY EXCITING TO SEE THOSE --
THE FIRST SET OF PROPOSALS COME
THROUGH.
I'M SO HAPPY THAT THEY ARE MUCH
SHORTER THAN CLINICAL TRIAL
CONCEPTS.
I -- AND DR. DERTIA DID SHARE
WITH US A LITTLE BIT OF
PRAGMATIC LUNG CANCER AT OUR
LAST MEETING AND WE TALKED
THROUGH A LOT OF, YOU KNOW, THE
LOWERING BURDEN OF REPORTING
EVEN WITH ADVERSE EVENTS THAT HE
GOT US TO A GREAT COMFORT LEVEL
THERE.
I'M WONDERING, YOU KNOW, AGAIN,
THIS IS JUST SO EXCITING.
HOW MANY TIMES HAVE WE SEEN HOW
SLOWLY CLINICAL TRIALS GO
THROUGH THIS PROCESS.
AND THEN BY THE TIME THAT IT IS
ACTIVATED, YOU KNOW, STANDARD OF
CARE MAY HAVE CHANGED AND, YOU
KNOW, IT IS A VERY FRUSTRATING
THING.
I SEE YOU, BOB. I HAVE A REALLY
QUICK QUESTION. YOU KNOW, IS
THERE CONSIDERATION OF HAVING
SOMEONE FROM NCOR ON THE INITIAL
-- YOU KNOW, REVIEWING THESE
THINGS TO JUST SEE THEY ARE
SCALEABLE TO RECRUITMENT AT NCOR
SITES TO BROADEN?
>>YEAH.
>>OKAY.
>>SEVERAL NCTN GROUPS ARE NCOR
SITES AND MENTIONING ONCE FIRST
WE LOOK AT THE IDEA AND WILL GET
MORE FULLY DEVELOPED PROPOSALS
BEFORE THINGS ARE TAKEN INTO
FULL PROTOCOL AND WILL OF COURSE
HAVE ADVOCACY INPUT AS WELL AS
NCOR AND COMMUNITY ONCOLOGY
INPUT INTO THOSE TRIALS AND YOU
ALSO ARE PROBABLY WELL AWARE
THAT AS IDEAS COME OUT OF NCTN
AND DISEASE COMMITTEES THERE IS
INPUT FROM EACH AND ALL GROUPS
DO THOSE THINGS AS WELL AS TO
WHAT IS FEASIBLE IN
ORGANIZATIONS.
>>YES.
>>OF COURSE, THAT IS DEFINITELY
THE PLAN AND IDEA THAT GETS --
WE GET FURTHER DEVELOPED.
>>THAT IS FANTASTIC.
BOB, YOU HAD A QUESTION?
>>I WAS JUST GOING TO ASK ARE
YOU HOPING THIS WOULD BE A WAY
TO PILOT TEST WAYS TO MAKE ALL
CLINICAL TRIALS MORE EXPEDIENT?
>>YES. THAT WOULD MAKE IT
INNOVATIVE. FOR EXAMPLE LONG
PRAGMATIC AND GOT LAUNCH THE IN
SOME WAYS AND WE DID THINGS IN A
VERY EXPEDITETIVE FASHION THAT
YOU CAN'T DO IT FOR EVERY TRIAL
AND DOING THAT FOR A COUPLE
TRIALS YOU CAN SHOW SOMETHING
COULD BE DONE AND YOU CAN SAY,
HEY, FOR THE RIGHT KIND OF
TRIAL; RIGHT?
YOU CAN CERTAINLY STREAMLINE
WHAT YOU COLLECT; RIGHT?
YOU CAN DO CERTAIN THINGS LIKE
WE ARE DOING WITH PRAGMATIC
TRIALS AND IF YOU DO THAT AFTER
A COUPLE TRIALS AND SHOW THE WAY
IT WORKS, YOU WILL SAY, HEY,
THAT MAY NOT BE SO INNOVATIVE
ANYMORE. WE KNOW HOW TO DO THIS
AND CAN INCORPORATE ACTIVITIES
INTO REGULAR WAY THAT WE DO
TRIALS.
IF SOMETHING IS NOVEL THAT WE
FIND AND TEST AROUND WAYS YOU
COLLECT DATA OR PULL IT OUT OF
HR THAT HELPS YOU DO SOMETHING
IN A TRIAL, OF COURSE, WE WOULD
THEN HOPE TO LAUNCH AND MAKE
THAT OR GET ADOPTED AS PART OF
OUR REGULAR CLINICAL TRIALS
WORKSTREAM.
YES. THAT IS INDEED THE IDEA
TAKING A LITTLE MORE RISK AND
TRYING THINGS OUT AND PUSHING
THE ENVELOPE ON THINGS, WHICH
YOU CAN'T DO FOR EVERY TRIAL AND
YOU PROBABLY ALL -- I THINK YOU
HEARD AND IF YOU HAVEN'T AND
MUST HAVE BEEN DISCUSSED AT YOUR
MEETINGS AND DISCUSSED A LOT
ABOUT BURDENS ON OUR WORKFORCE.
WE -- I HAVE A -- I HAVE A LOT
OF THE WORK THAT WE DO COMES
FROM LOTS OF REALLY DEDICATED
PEOPLE OFTEN UNDER RESOURCE AND
STAFF. WE CAN ONLY PUSH FOR MY
RESEARCH FOR A FEW TRIALS
WITHOUT BREAKING OUR SYSTEM.
>>THANK YOU FOR THAT QUESTION,
BOB.
YOU KNOW, DR. PRINDIVILLE, I
CAN'T SAY HOW EXCITING THIS IS
BECAUSE, YOU KNOW, WE KNOW HOW
EXPENSIVE ADMINISTRATION IS OF A
CLINICAL TRIAL AND I NEVER KNEW
THIS UNTIL LAST SUMMER.
FINDING WAYS TO MAKE TRIALS
ADAPTIVE AND KEEP WHAT WORKS
AND, YOU KNOW, ONLY REPLACING
WHAT YOU NEED.
IT IS LIKE IF I HAVE A FLAT
TIRE, I DON'T REPLACE THE WHOLE
CAR BUT CHANGE THE TIRE.
YOU KNOW, IF WE CAN FIND A WAY
TO MAKE OUR CLINICAL TRIALS MORE
NIMBLE, THAT IS A VERY
SIMPLISTIC VIEW. YOU KNOW, SO
MANY TIMES SO MUCH EFFORT GOES
INTO THIS LARGE-SCALE DESIGN
ESPECIALLY WITH PHASE 2 AND 3
TRIALS AND THEN, YOU KNOW, IT IS
ALREADY OUTDATED.
I'M VERY EXCITED ABOUT THESE
EFFORTS.
ANYONE -- SORRY.
>>SORRY THE SECOND ONE AND
IMPORTANT THING THAT GETS TO
WHAT BOB WAS SAYING IS, YOU
KNOW, WE ARE TRYING -- THIS IS
ANOTHER AVENUE THAT WE ARE
TAKING IN ADDITION TO ALL OF THE
THINGS THAT WE POINTED OUT. YOU
KNOW, THAT IS WHY -- YOU KNOW,
AS YOU HAVE BEEN HEARING ABOUT
BECAUSE -- THIS IS TAKING A
LITTLE MORE RISK TO TRY TO PUSH
A FEW THINGS FORWARD TO SEE WHAT
WE CAN DO INNOVATIVELY WITH OUR
SYSTEM.
>>THAT IS FANTASTIC.
NICOLE, YOU HAVE A QUESTION?
>>THANK YOU. I THINK THIS IS
FANTASTIC. REALLY IT IS
EXCITING TO SEE THAT YOU ARE
BRINGING IN NEW PERSPECTIVES ON
HOW CLINICAL TRIALS COULD BE RUN
AND MAYBE RUN MORE EFFECTIVELY.
I DON'T KNOW WHAT IS MEANT BY --
YOU MENTIONED THAT YOU WANT
INNOVATION BUT IT DOESN'T -- IT
IS NOT TOO DISRUPTIVE OF CURRENT
PROCESSES.
SO, ONE QUESTION THAT I HAD IN
MY MIND AS I WAS THINKING
THROUGH THIS IS, YOU KNOW, WHAT
IS -- WOULD SOMETHING -- WOULD A
TRIAL BE CONSIDERED APPROPRIATE
FOR THIS IF THEY WANTED TO USE
EXTERNAL CONTROLS OR REAL-WORLD
DATA, FOR INSTANCE?
THERE IS LOTS OF INTEREST IN
THAT. I KNOW THAT FDA HAD
GUIDANCE OF USE OF REAL WORLD
DATA IN CLINICAL TRIALS THAT IS
NOT AS COMMONLY SEEN OR COMMONLY
AS ACCEPTED AND WONDERING IF IT
IS AN INNOVATIVE APPROACH.
>>YEAH. YES. DIFFERENT WAYS
COLLECTING DATA AND/OR LOOKING
AT THINGS CERTAINLY COULD BE
CONSIDERED TO BE DONE. OF
COURSE, YOU KNOW, IF IT DEPENDS
WHAT THE BASIC TRIAL DESIGN IS,
YOU KNOW, AND WHAT WOULD BE
ACKRECHTED AND OBVIOUSLY IF
SOMETHING IS DONE UNDER IND OR
NOT AND YES. WE ARE OPEN TO
NOVEL WAYS OF LOOKING AND
COLLECTING DATA AND/OR REALLY
WHAT YOU ARE TALKING ABOUT IS
TRIAL DESIGNS.
RIGHT?
SO.
>>YES.
>>OKAY.
>>I THINK WE WILL -- ONE THING
WE REALLY HOPE TO AS WE GET OUR
FIRST ROUND OF IDEAS AND LOOK AT
THIS, I THINK IT WILL HELP US
SORT OF COMMUNICATE IN EXPANDING
WHAT OUR -- YOU KNOW, WHAT ARE
DIFFERENT TYPES OF THINGS THAT
WE ARE CONSIDERING; RIGHT?
WE HAVE NOW BEEN PRETTY WIDE
OPEN IN TERMS OF NOVEL TRIAL
DESIGNS.
AS WELL AS CONSIDERING DIFFERENT
WAYS OF COLLECTING DATA AND
DOESN'T HAVE TO JUST BE A NOVEL
AND SCIENTIFIC QUESTION THAT
COULD BE REALLY SOMETHING FOR
WHICH THERE IS A NOVEL WAY THAT
IS THAT OPERATIONALLY WE DO
SOMETHING THAT ULTIMATELY MAY
HAVE AN IMPACT ON OUR SYSTEM.
>>GREAT. THANK YOU.
>>SO, AS WE BECOME MORE NIMBLE
INCORPORATING NOVEL TRIAL
DESIGNS IT IS A
COMMENT/QUESTION, I GUESS. HOW
CAN ENSURE AND CONTINUE TO
SIGNAL AND CONTINUE TO BE
PATIENT-CENTRIC; RIGHT?
ONE DESIGN OF PRAGMATICA
ELIMINATES COLLECTION OF
PATIENT-REPORTED OUTCOMES THAT
PATIENTS MAY FEEL IS IMPORTANT
AND TRADE OF BALANCE TO CONTINUE
TO ACHIEVE TO CONTINUE TO SIGNAL
WE ARE STILL GOING TO CONTINUE
TO BE PATIENT-CENTRIC AS WE
INTRODUCE URGENCY.
>>YES. I AGREE WITH YOU. I
THINK THERE IS A VERY IMPORTANT
BALANCE BETWEEN, YOU KNOW,
COLLECTING AND BEING
PATIENT-CENTRIC AND PARTICULARLY
PATIENT-REPORTED OUTCOMES.
THERE IS NO REASON WE CAN'T
COLLECT THE IMPORTANT ONES IN
THE TRIALS.
RIGHT?
THIS IS NOT NECESSARILY
LIMITING. IT IN MANY WAYS
DEPENDS ON THE TRIAL DESIGN AND
WHAT TRIAL IS AND DEPENDING ON
STUDY QUESTION AND
PATIENT-REPORTED OUTCOMES COULD
BE MOST IMPORTANT PART OF A
TRIAL IF LOOKING AT CERTAIN
TYPES OF DISEASES AND/OR AGENTS
WITH SIGNIFICANT TOXICITY FOR
PATIENTS.
I THINK IT IS VERY MUCH A TRIAL
BY TRIAL BASIS IN MAKING SURE
THAT IT GETS INCORPORATED INTO
THE RIGHT SETTING AND WHAT THE
STUDY QUESTION IS.
BECAUSE IT IS DEFINITELY NOT
INTENT TO NOT COLLECT PATIENT
REPORTED OUTCOMES ARE INCREDIBLY
IMPORTANT COMPONENT WHAT WE DO
AND IS A MATTER OF IN WHAT
SETTING AND TRIAL THAT MIGHT NOT
BE -- THAT IS SORT OF MY
THINKING ON THAT.
>>I THINK ANNIE IS ON MUTE.
>>THERE WE GO. THANK YOU FOR
THE QUESTION AND RESPONSE.
IT IS SOMETHING THAT WE TALKED A
BIT ABOUT WITH DR. DORSO AS
WELL. IT IS SOMETHING OF
CONCERN TO US.
I SEE WE ARE A LITTLE OVER TIME
AND IF THERE IS A PRESSING
QUESTION, WE WANT TO MAKE SURE
IT GETS ANSWERED.
IT LOOKS LIKE WE ARE ALL CLEAR.
SO S
SO, THANK YOU FOR SPENDING TIME
ON THAT AND WE HOPE TO HEAR
FUTURE MEETINGS AND THANK YOU
FOR TIME TO REPORT.
>>THANK YOU.
>>SO, NOW I GUESS THIS IS THE
MAIN EVENT HERE THAT IS HEARING
LEGISLATIVE UPDATE FROM HOLLY
GIBBONS DEPUTY DIRECTOR FROM NCI
AND INVITE YOU NOW TO DELIVER
YOUR LEGISLATIVE UPDATE.
>> THANK YOU SO MUCH AND FOR
HAVING ME TODAY.
STARTING WITH RECENT DEBT LIMIT
AND BUDGET DEAL AND GO AHEAD AND
ADVANCE TO THE NEXT SLIDE.
LY SHARE UPDATES ON ONGOING
FY2024 APPROPRIATIONS PROCESS
AND HOUSE VERSUS SENATE
CONGRESSIONAL BRIEFINGS AND
LOOKING TO EARLY FALL AND
ACTIVITIES WE ARE EXPECTING AND
NEXT SLIDE, PLEASE.
WANTING TO SHARE A BRIEF RECAP
WHERE CONGRESS AND
ADMINISTRATION ENDED UP.
WE AVOIDED REACHING THE DEBT
LIMIT AND DR. LOWY MENTIONED
AGREEMENT REACHED DEBT CEILING
TO JANUARY 2025 AND AGREEMENT
WAS PART OF LARGER FISCAL
RESPONSIBILITY ACT OR FRI AND
PASSED ON HOUSE AND JUNE THIRD 2
DAYS AHEAD OF DEFAULT DATE ON
JUNE FIFTH. NEXT SLIDE, PLEASE.
SHARING NATIONAL JOURNAL SLIDE
FOR REFERENCE AND WELCOME TO
COME BACK TO IT IN ALL DETAILS
AND WANTED TO COVER HOW
AGREEMENTS PART OF THE BILL
EFFECT NCI AND OTHER FEDERAL
AGENCIES AND AGREEMENT INCLUDES
TWO YEARS SPENDING CAPS AS DR.
LOWY REFERENCED ALLOWING DEFENSE
FUNDING TO INCREASE BY 3% THAT
IS AMOUNT REQUESTED IN
PRESIDENT'S BUDGET PROTECTING
VETERAN'S HEALTH CARE SPENDING
CAPPING FY2024 NONDEFENSE
DISCRETIONARY SPENDING IN FY23
LEVELS AND POINTING OUT
NONDEFENSE DISCRETIONARY
SPENDING IS WHERE NCI AND
[INDISCERNIBLE] -- 1% INCREASE
AND WOULD ALSO RESCIND ABOUT 30
BILLION DOLLARS OF UNOBLIGATED
COVID RELIEF FUND AND RESCIND
$20 BILLION OF IRS DATA
ALLOCATED THROUGH INFLATION
REDUCTION ACT AND IS A STICK IF
CONGRESS DOESN'T PASS ALL 12
SPEVENDING BILLS BY JANUARY 1ST
THAT IMPOSES IMMEDIATE 1%
OVERALL CUT THAT IS PERMANENT IF
WORK IS NOT DONE BY END OF
APRIL. NEXT SLIDE, PLEASE.
THAT IS JUNE THIRD EARLIER THIS
MONTH AND LOTS HAPPENS IN TWO
WEEKS SINCE THEN AND
RESPONSIBILITY ACT GROUP OF
11GOP MEMBERS DERAILED HOUSE
PROCEDURAL PROCESSES BLOCKING A
RULE TO BRING UP UNRELATED BILLS
THAT ARE UNCONTROE VER SHAL FOR
GOP MEMBERS AND SHUT DOWN
EFFECTIVELY HOUSE ACTIVITIES FOR
SEVERAL DAYS AND GOAL WAS TO
SEND A MESSAGE THAT BUDGET
AGREEMENT DIDN'T GO FAR ENOUGH
AND THEY WANTED TO CONTINUE TO
PUSH FOR A MORE CONSERVATIVE
APPROACH TO FEDERAL SPENDING
THAT IS A PRESSURE THEY OR SMALL
COALITION OF MEMBERS CAN IMPOSE
BASED ON FACT THAT THERE IS A
SLIM MAJORITY IN THE HOUSE AND
222GOP MEMBERS IN THE HOUSE AND
MAGIC NUMBER TO PASS ANY PIECE
OF LEGISLATION IS 2018 AND
SPEAKER CAN LOSE ONLY FOUR
VOTES.
SPEAKER MCCARTHY AND LEADERSHIP
TEAM EMERGED MULTIPLE TIMES --
BRINGING LEGISLATION TO THE
FLOOR AND RE-DEFINING FISCAL
RESPONSIBILITY ACT FUNDING
LEVELS AS CEILINGS NOT FLOORS
AND MORE ON THAT IN NEXT SLIDE,
PLEASE.
SO, THIS IS A BIT OF A PLOT
TWIST MONDAY JUNE 12TH WE SEE
HOUSE APPROPRIATIONS CHAIR AND
HOUSE WILL MARK FY24 SPENDING
BILLS TO FY22 TOP LEVEL FUNDING
AMOUNT THAT IS $119 BILLION LESS
THAN FY23 THAN AMOUNTS
NEGOTIATED IN FISCAL
RESPONSIBILITY ACT. FY22 LEVEL
IS ESSENTIALLY LEVEL THAT HOUSE
GOP ORIGINALLY RALLIED AROUND IF
HEADED INTO THE DEBT CEILING
NEGOTIATIONS AND SENATE AND
CONTRAST WILL WRITE BILLS TO
FY23 LEVELS AS AGREED TO IN
BUDGET DEAL.
THIS SETS UP WHAT WE EXPECT TO
BE A BIT OF A COLLISION COURSE
BETWEEN TWO CHAMBERS AND HOUSE
AND SENATE TYPICAL DON'T PROPOSE
THE SAME NUMBERS CONFERENCE
PROCESS TO ECONCRIME THE TWO
BILLS AND THIS IS A BIG
DIFFERENCE THAT WILL MAKE FOR A
REALLY CHALLENGING SEPTEMBER
THROUGH DECEMBER OR POTENTIALLY
INTO APRIL AND WILL SEE HERE IN
CLIP THAT CHAIR GRANGER
REITERATED BUDGET DEAL SET A
CEILING FOR FY24 BILLS AND
CONTINUE SO SEE REPORTED IN PAST
WEEK OR SO LAST WEEK AFTER HER
ANNOUNCEMENT AS FULL HOUSE
APPROPRIATIONS COMMITTEE
APPROXIMATELY 60 MEMBERS IN THE
HOUSE GATHERED FOR MARKUP OF
AGRICULTURAL FDA BILL AND
MARYLAND IN UPPER RIGHT VOICED
CONCERNS ABOUT APPROACH AND
CONGRESSMAN HOYER IS FORMER
HOUSE MAJORITY LEADER RETURNING
TO APPROPRIATIONS COMMITTEE AND
118TH CONGRESS EMPHASIZED
EXTREME DISAPPOINTMENT AND WHAT
HE SEES AS GOP COLLEAGUES GOING
BACK TO FISCAL RESPONSIBILITY
ACT AND WANTED TO MAKE A COMMENT
ON CHAIR GRANGER'S STATEMENT
LAST WEEK ELUDED TO DECLINE 115
ABOUTLE IN UNSENT FUNDS AND WERE
NO DETAILS YET ON WHAT -- FROM
WHERE FUNDS WOULD BE RESCINDED
THAT COULD HELP CLOSE THAT $119
BILLION GAP BETWEEN THE
POTENTIAL HOUSE AND SENATE
LEVELS.
NEXT SLIDE, PLEASE.
SO, I WANTED TO JUST SUMMARIZE
HERE THIS IS WHERE WE ARE
HEADING INTO FY2024
APPROPRIATIONS NEGOTIATIONS AND
SENATE BILLS AND HOUSE BILLS TO
FY22 LEVELS AND PROTECTING
DEFENSE AND VETERANS AND NOTING
LABOR HHS BILL IS ABOUT A $60
BILLION DIFFERENCE BETWEEN FY23
AND FY22 AND FINALLY STILL
WAITING TO LEARN MORE ABOUT WHAT
$115 BILLION PLAN FOR RECISIONS
WOULD BE TO MAKE IT HARD TO
PREDICT WAREHOUSE WILL LAND.
NEXT SLIDE, PLEASE.
THIS TABLE IS JUST A REMINDER
WHERE WE ARE AS WE WAIT TO SEE
THOSE HOUSE AND SENATE PROPOSALS
AND IT OUTLINES FY23 ENACTED
FUNDING AND PRESIDENT'S BUDGET
REQUEST FOR FY24 AND WE EXPECT
TO LEARN MORE ABOUT THAT IN
COMING WEEKS FOR ALL REASONS WE
JUST DISCUSSED NUMBERS IN HOUSE
AND SENATE THAT WILL LOOK
DIFFERENT FOR THESE AGENCIES
VERY LIKELY AND SO FAR IN TERMS
OF COMMITTEE ACTIVITY IN THE
HOUSE HOMELAND SECURITY AND
LEGISLATIVE BRANCH FULL
COMMITTEE MARKUPS ARE TODAY AND
DEFENSE BILL AND ENERGY AND
WATER BILL WILL BE MARKED
TOMORROW AND AGRICULTURE AND FDA
AS WELL AS MILITARY CONSTRUCTION
FDA WERE MARKED IN THE HOUSE AND
LABOR HHS HASN'T MARKED UP YET
AND BEGINNING THIS WEEK FULL
COMMITTEE MARKUP WITH
CONSTRUCTION VA BILL AND
AGRICULTURE FDA BILL SCHEDULED
FOR TOMORROW AND COMMITTEES ARE
PLANNING TO CONSIDER
SUB-COMMITTEE ALLOCATIONS FOR
ALL 12 BILLS TOMORROW AND THOSE
LEVELS HAVE YET TO BE RELEASED
AND THIS MORNING REPORTING WAS
INDICATING SENATOR SUSAN COLLINS
WAS WAITING TO RECEIVE SEVERAL
SUB-COMMITTEE NUMBERS.
NEXT SLIDE, PLEASE.
THIS GRAPH IS A QUICK LOOK AT
TRENDS OVER TIME AND AGAIN IS
STILL UNCLEAR WHETHER IT WILL BE
FEASIBLE TO MEET THE PRESIDENT'S
REQUEST IN A CHALLENGING BUDGET
YEAR.
NEXT SLIDE, PLEASE.
I DID WANT TO HIGHLIGHT THAT WE
HAD NIH BUDGET HEARING IN EARLY
MAY WITH SENATE LABOR HHS
APPROPRIATIONS SUB-COMMITTEE AND
DR. LOWY HERE REPRESENTED NCI
SHAKING HANDS WITH COMMITTEE
SHARE AND RANKING MEMBER SENATOR
SHELLY FROM WEST VIRGINIA ON THE
RIGHT AND DR. LOWY JOINED ACTING
DIRECTOR AT NIH DR. LARRY TABAK
AND SEVERAL DIRECTORS OF THE
HEARING IT WAS BIPARTISAN AND
GENERALLY SUPPORTIVE EMPHASIZING
IMPORTANCE OF INVESTMENTS OF
BIOMEDICAL RESEARCH AT NIH AND
HOUSE SIDE THEY CHOSE NO THE TO
HAVE A STANDALONE NIH BUDGET
HEARING THIS YEAR AND DR. TABAK
JOINED CDC LEADERSHIP AND
PREPAREDNESS AND RESPONSE
LEADERSHIP TO TESTIFY AT HOUSE
LABOR HHS SUB-COMMITTEE HEARING
FOCUSED ON MANAGEMENT OF COVID
PUBLIC HEALTH EMERGENCY.
NEXT SLIDE, PLEASE.
I WANTED TO TAKE A VERY BRIEF
BREAK FROM BUDGET AND
APPROPRIATIONS SHARING
CONGRESSIONAL ACTIVITY THAT NCI
COLLEAGUES PARTICIPATED IN
RECENTLY AND ON LEFT WE HAVE AMY
WHO LEADS NCI'S COMPARATIVE
ONCOLOGY PROGRAM STUDYING
APPROACHES TO TREAT CANCERS
OCCURRING NATURALLY IN PET DOGS
AND IN HUMANS AND WHY SHE IS
HOLDING CUTE PUPPY THERE AND ON
RIGHT STAN LIP CO WITS WHO IS AT
NCI'S INTRAMURAL CENTER FOR
CANCER RESEARCH AND MAKING
REGULAR REMINDER TO GROUP AND IF
ANY ORGANIZATIONS ARE HOSTING
BRIEFINGS WHERE YOU THINK IT
MIGHT BE HELPFUL TO HAVE NCI
RESEARCH UPDATE DON'T HESITATE
TO REACH OUT. WE ARE HAPPY TO
HELP FACILITATE THAT.
NEXT SLIDE, PLEASE.
SO, COMING UP, APPROPRIATIONS
ARE NOT ONLY MUST PASS BILLS
WITH SEPTEMBER DEADLINE. THERE
ARE FDA USER FREE PROVISIONS FOR
ANIMAL DRUGS THAT EXPIRE
SEPTEMBER 30TH AS WELL AND ALL
HAS YARDS PREPAREDNESS ACT
EXPIRES SEPTEMBER 30TH AND --
BOTH ARE MARKING UP RESPECTIVE
NDA PROPOSALS TODAY AND IF TIME
TO SPARE WE WILL SEE THERE IS A
RUNNING LIST OF POSSIBLE
COMPETING PRIORITIES INCLUDING
OVERSITE ACTIVITY AND DRUG
PRICING LEGISLATION.
NEXT SLIDE, PLEASE.
WRAPPING UP WHERE I OFTEN DO
WITH A QUICK LOOK AT
CONGRESSIONAL CALENDAR. WE HAVE
102 DAYS ON CALENDAR UNTIL END
OF THE FISCAL YEAR AND 25 OF
THOSE ARE DATES WHEN BOTH HOUSE
AND SENATE ARE IN SESSION.
THE NEXT NCRA MEETING IS
CURRENTLY SCHEDULED FOR
WEDNESDAY, OCTOBER 4TH.
IF THERE IS NOT A GOVERNMENT
SHUTDOWN AND WE ARE ABLE TO MEET
ON THAT DATE AS PLAN THE WE WILL
HAVE LOTS TO CATCH UP ON
ACTIVITIES OVER THE SUMMER.
NEXT SLIDE, I AM HAPPY TO TAKE
QUESTIONS IF WE HAVE TIME AND WE
ARE RUNNING UP AGAINST THE
DEADLINE. YOU HAVE MY E-MAIL.
PLEASE FEEL FREE TO REACH OUT IF
THAT WOULD BE HELPFUL.
THANK YOU.
>>THANK YOU SO MUCH, HOLLY.
IT IS ALWAYS JUST SO EYE-OPENING
TO GET THE UPDATE AND WORK THAT
YOU AND YOUR STAFF HAVE TO KEEP
UP WITH EVERYTHING.
SO, ARE WE LOOKING, YOU KNOW, AT
CONTINUING RESOLUTIONS IN THE
FUTURE?
WHAT IS YOUR SENSE OF WHAT THE
FUTURE MIGHT HOLD?
>>ALMOST CERTAIN UNTIL SOMETIME
LATER IN THE FALL. YOU KNOW, I
THINK THEY WILL TRY TO GET AS
MUCH DONE ON HAMMERING OUT
INDIVIDUAL BILLS BETWEEN NOW AND
END OF SEPTEMBER. I DON'T KNOW
THEY WILL BE ABLE TO MAKE THAT
DEADLINE THAT USUALLE DOESN'T
HAPPEN AND HATE TO MAKE HARD
PREDICTIONS THERE IS VERY THAT
DEADLINE OF JANUARY 1ST AND THAT
STICK I MENTIONED EARLIER ON.
I THINK THAT WILL PLAY A ROLE IN
THE NEXT DATE THEY ARE WORKING
TOWARDS.
I THINK SHUTDOWNS ARE VERY HARD
TO PREDICT.
WITH A TWIST OF THE HOUSE NOW
TURNING BACK TO FY22 LEVELS AND
IT IS GOING TO MAKE IT MORE
DIFFICULT FOR THEM TO CONFERENCE
AND MUCH MORE DIFFICULT.
WE ARE SEEING LOTS OF POLITICAL
AND BUDGET REPORTERS THAT HAVE
BEEN IN THE FIELD FOR A LONG
TIME STARTING TO SPECULATE NOW
ABOUT THE POTENTIAL FOR A
SHUTDOWN.
I'M NOT GOING TO CERTAINLY MAKE
HARD PREDICTIONS THERE.
I HOPE TO REALLY SEE YOU ON
OCTOBER 4TH.
>>FINGERS CROSSED AND FURTHER
QUESTION IF NO ONE ELSE HAS ANY
QUESTIONS.
>>SURE.
>>I SAW YOU TOUCH UPON IT IN
WRITTEN RHO RT THAT WE RECEIVED.
>>UH-HUH.
>>WE ARE HEARING DEAR COLLEAGUE
LETTERS CIRCULATING ON DRUG
SHORTAGE AND IS THERE
TRACTIONING ON ANYTHING OR IS IT
UNLIKELY THAT SOMETHING WILL
HAPPEN THIS SUMMER?
>> THERE IS A LOT OF INTEREST
THAT I HAVE SEEN SEVERAL DEAR
COLLEAGUES AND COUPLE OF
HEARINGS ONE EARLIER IN THE
SPRING AND ONE RECENTLY EARLIER
IN MAY A FEW DIFFERENT PROPOSALS
ARE ADDRESSING PIECES AND
POTENTIAL SOLUTIONS NOTHING THAT
LOOKED COMPREHENSIVE THAT FOLKS
HAVE RALLIED AROUND AND
CHALLENGE WILL BE LIST THAT I
SHOWED YOU AT END OF COMPETING
PRIORITIES AND ARE THERE ANY
PROVISIONS THAT MIGHT BE TACKED
TO OTHER LEGISLATION
POTENTIALLY. I THINK AS DR.
LOWY ELUDED TO EARLIER IT IS A
MUCH BROADER SYSTEMS CHALLENGE
THAT WHILE LEGISLATION HELPS
ADDRESS SOME PIECES MIGHT NOT
SOLVE ENTIRE ISSUE AND WE ARE
KEEPING AN EYE ON IT THOUGH.
>>THANK YOU SO MUCH. ANYBODY
HAVE QUESTIONS OR COMMENTS?
WE STILL HAVE OUR --
SEEING NONE THANKS FOR PROVIDING
COMPREHENSIVIZE TO UNDERSTAND
OVERVIEW WHAT IS GOING ON.
>>THANK YOU.
>>LOOK FORWARD TO SEEING YOU
AGAIN NEXT TIME IF WE SEE EACH
OTHER NEXT TIME.
>>IF YOU HAVE FOLLOW-UP
QUESTIONS OR LOOKING AT WRITTEN
UPDATE FEEL FREE TO REACH OUT.
HAPPY TO FOLLOW UP.
>>THANKS SO MUCH.
OKAY. I THINK WE ARE DOWN TO A
LITTLE BOARD BUSINESS AMY UNLESS
YOU HAVE SOMETHING ELSE FOR NOW.
>>THAT IS IT. HOME STRETCH.
>>OKAY. LAST THING ON THE
AGENDA IS APPROVING SUMMARY OF
LAST MEETING 8 EIGHTH NCRA
MEETING BACK IN MARCH WAS IT
MARCH? MY GOSH. IT WAS MARCH.
>>YUP.
>>IF I CAN HAVE SOMEONE MOVE TO
APPROVE THOSE.
>>SO MOVED.
>>OKAY. SECOND?
>> SECOND.
>>EXCELLENT. THANKS SO MUCH.
WE HAVE A MOTION TO APPROVE THE
MEETING SUMMARY AND ALL THOSE
WHO ARE IN FAVOR SAY AYE OR PUT
IT IN THE CHAT OR RAISE A HAND.
>>AYE.
>>ANY OPPOSED? OKAY. SEEING
NONE.
THE SUMMARY FROM LAST MEETING IS
APPROVED AND FINALIZED.
SO, I GUESS THAT IS IT. AMY,
UNLESS YOU HAVE SOMETHING ELSE?
>>NO. THAT IS -- NO. THAT IS
THE LAST ITEM. I DO AS ALWAYS
WANT TO THANK YOU FOR YOUR TIME.
I THOUGHT THAT THE DISCUSSION
WAS REALLY, REALLY AWESOME TODAY
AND HELPFUL TO NCI AND CANCER
PATIENTS YOU REPRESENT AND
ISSUES WE TALKED ABOUT AFTER DR.
LOWY'S UPDATE AND DR. SHIELS
UPDATE AND CTU WE COVERED THE
GAMUT THAT WAS HELPFUL AND
CONSTRUCTIVE FEEDBACK THROUGHOUT
AND THANKS FOR TIME AND
ATTENTION AND FOR BEING SO
THOUGHTFUL.
I WANT TO THANK THE ADVOCACY
OFFICE STAFF AND MANY WHOM YOU
WORK WITH INDIVIDUALLY THAT DOES
LOTS OF WORK GETTING US HERE TO
THIS DAY TO MAKE SURE WE HAVE
CONTENT SET UP FOR A GREAT
DISCUSSION AND THEY DO A
TERRIFIC JOB THAT I APPRECIATE
AS WELL AND NEXT MEETING IS IN
OCTOBER.
WE ARE LOOKING AT THAT NOW AND
WILL SEND OUT DETAILS FOR WHAT
WE HAVE PLANNED IN THE VERY NEAR
FUTURE.
STAY TUNED. GIVING EVERYBODY
LOTS OF ADVANCED NOTICE WHAT WE
ARE UP TO IN OCTOBER STAY TUNED.
TURNING IT TO YOU TO CLOSE THE
MEETING AND THANKS FOR TIME
TODAY AND LOOK FORWARD TO
TALKING WITH ALL OF YOU WELL
BEFORE OCTOBER.
>>THANK YOU TO AMY AND VINCENT
AND WHOLE TEAM FOR PULLING THIS
MEETING TOGETHER. I THANK
EVERYONE FOR THE WONDERFUL
DIALOGUES AND PERSPECTIVES THAT
EVEN ADDS IS REALLY AMAZING AND
LOVE HOW WE ARE ALL COMING AT
THIS AT DIFFERENT PERSPECTIVES
AND PASSION THAT WE BRING TO
THIS.
SO, I GUESS UNTIL WE SEE YOU
NEXT TIME, WE ARE ALL DONE!
MEETING IS ADJOURNED.
>> THANK YOU, GUYS.
>>THANK YOU.
>>BYE, EVERYONE.
>>