>>I WOULD LIKE TO WELCOME
EVERYONE, PARTICULARLY THE
MEMBERS TO THE NATIONAL CANCER
ADVISORY BOARD OTHERWISE KNOWN
AS NCAB, AS WELL AS NCAB
EXOFFICIO MEMBERS STAFF, AND
GUESTS.
JUST A FEW NOTES.
MEMBERSOF THE PUBLIC WHO MAY
WISH TO EXPRESS THEIR VIEWS
REGUARDING ANY ITEMS DISCUSSED
DURING TODAY'S MEETING, MAY DO
SO BY WRITING TO DR. PAULETTE
GRAY, ANY STATEMENTS OR
QUESTIONS SUBMITTED BY MEMBERS
OF THE PUBLIC WILL RECEIVE
CAREFUL CONSIDERATION.
AS BOARD MEMBERS I WANT TO
REMIND YOU THAT YOU MUST ABSENT
YOURSELF VIRTUALLY DURING
SPECIFIC DISCUSSIONS, WHENEVER
YOUR PARTIC PAITIONZ IN
DELIBERATIONS ON A PARTICULAR
PRODUCT, PROGRAM, OR OTHER
SPECIFIC MATTER WOULD CONSITUTE
A CONFLICT OF INTEREST OR CREATE
THE APPEARANCE OF 1.
IT'S INCUMBENT UPON YOU TO
ADVISE THE EXECUTIVE SECRETARY
DR. GRAY TO ABSTAIN FROM ANY
PARTICIPATION IN DISCUSSION OR
ACTION REGUARDING THIS MATTER.
IN LIGHT OF THE CURRENT POLICIES
GOVERNING CONFLICT OF INTEREST
BASED ON FINANCIAL HOLDINGS FOR
SPECIAL GOVERNMENT EMPLOYEES
WHICH INCLUDES ALL OF THE
MEMBERS OF THE BOARD, WE MUST
DEPEND ON YOU TO VOLUNTARILY
ABSENT YOURSELF DURING ANY
DISCUSSIONS OF MATTERS THAT
COULD CONCEIVABLY IMPACT THE
STATUS OF THOSE HOLDINGS AND WE
HAVE TO TRUST YOUR JUDGMENT IN
THESE INSTANCES AND PLEASE
ABSENT ACCORDINGLY.
DURING ANY CLOSED SESSION, ANY
MATERIALS OR DISCUSSIONS OF
CONFIDENTIAL NATURE DELIBERATED
UPON TODAY ARE PRIVILEGED
INFORMATION AND ARE MADE
AVAILABLE TO YOU UPON A NEED TO
KNOW BASIS, SUCH DELIBERATIONS
ARE PRIVATE AND THEY'RE CONTENTS
SHOULD NOT BE DIVULGED.
SO ON THE AGENDA THERE ARE THE
FUTURE MEETING DATES FOR YOUR
REVIEW.
WE DO NEED TO,A PROVE THE
DIAGRAM 5-7 TWEND 22 JOINT
BSA/NCAB SUMMARY.
SO I NEED TO CALL FOR A MOTION
TO,A PROVE THE MEETING SUMMARY.
DO WE HAVE A MOTION?
>>SO MOVED.
>>SECOND?
>>PLEASE OPEN YOUR MIC IF
THERE'S A SECOND.
>>SECOND.
>>SO IT'S BEEN PROPERLY MOVED
AND SECONDED, IS THERE ANY
DISCUSSION?
IF NOT, WE CAN VOTE ON APPROVAL
OF THE MEETING SUMMARY.
I WILL ASK IF THERE ARE ANY
NAYS?
DOES ANYONE NEED TO ABSENT?
P A ULETTE, IT LOOKS AS IF WE
HAVE A UNANIMOUS VOTE.
>>OKAY.
>>REGARDING QUORUM, BY LAW A
QUORUM OF BOARD MEMBERS IS
REQUIRED FOR EACH INSTANCE IN
WHICH A VOTE MAY OCCUR WHETHER
IN OPEN OR CLOSED SESSION.
DURING THIS MEETING A MINIMUM OF
10 APPOINTED MEMBERS MUST BE
PRESENT TO VOICE THEIR VOTES.
SINCE WE CAN'T PREDICT THE TIME
OR OCCURRENCE OF ANY MOTION,
YOUR PRESENCE DURING THE MEETING
IS REALLY CRITICAL FOR ALL
ASPECTS OF THE SEGMENTS OF THE
MEETING.
P A ULETTE, DO WE HAVE A QUORUM?
>>YES, WE HAVE A QUORUM.
>>AND TO INSURE WE REDUCE
POTENTIAL INTERRUPTIONS DURING
THE MEETING, PLEASE MAKE SURE
THAT YOU MUTE YOUR MICROPHONES
IF YOU'RE NOT TALKING AND REMAIN
SO UNTIL RECOGNIZED BY EITHER
ME, P A ULETTE, MONICA OR THE
SPEAKER.
WE WILL START THE MEETING, THE
AGENDA WILL START WITH THE
REPORT FROM THE NCI DIRECTOR,
DR. MONICA BERTAGNOLLI, MONICA?
>>THANK YOU SO MUCH JOHN AND
I'M DELIGHTED TO BE WITH YOU ALL
TODAY.
A LOT'S HAPPENED SINCE WE LAST
MET AND I WILL MOVE ALONG
BECAUSE I HAVE A LOT TO COVER.
IN ACCIDENT SLIDE, PLEASE.
WE'RE GOING TO TALK ABOUT RECENT
PROGRESS AND WHAT IT WILL TAKE
TO SUSTAIN AND REALLY ACCELERATE
IT, I LITTLE BIT ABOUT BUDGET
OUTLOOK AND SOMETHING ABOUT
NCAB'S ROLE IN THE NATIONAL
CANCER PROGRAM.
NEXT SLIDE.
IT'S BEEN A BIG WEEK FOR
PRESIDENT BIDEN'S COMMITMENT TO
PROGRESS AGAINST CANCER,
FEBRUARY 2nd MARKED THE 1 YEAR
ANNIVERSARY SINCE THE PRESIDENT
ANNOUNCED A REIGNITED CANCER
MOONSHOT AND TUESDAY NIGHT WE
HEARD IN THE STATE OF THE UNION
ADDRESS THAT HE INTENDS TO GO
BIG IN ORDER TO ACHIEVE BOLD
GOALS WORTHY OF COMPARISON TO
THE EFFORT THAT GOT US TO THE
MOON IN 1969.
A 50% REDUCTION IN CANCER
MORTALITY IN 25 YEARS, AND ALSO
TO END CANCER AS WE KNOW IT
WHICH WE TAKE TO MEAN THAT ALL
PEOPLE WITH CANCER LIVE FULL AND
ACTIVE LIVES AND THAT CANCER IS
PREVENTED AS MUCH AS POSSIBLE SO
THAT MORE PEOPLE DON'T HAVE TO
FACE THIS DIAGNOSIS.
EVER SINCE FIRST TAKING ON THE
CANCER MOONSHOT, DURING THE
OBAMA ADMINISTRATION, NOW
PRESIDENT BIDEN HAS BEEN
UNWAVERING IN SUPPORT OF WHAT WE
ALL SEEK TO DO.
A SIGNIFICANT DIFFERENCE THOUGH
IN THIS REIGNITED MOON SHOT IS A
CALL BY FOR AN ALL OF GOVERNMENT
AND ALL OF SOCIETY APPROACH.
WITH CONCERN FOR THE PATIENT AT
THE CENTER OF EVERYTHING THAT WE
DO.
SO OVER THE PAST--OVER THE FIRST
YEAR OF THIS REIGNITED MOON SHOT
WE HAVE TAKEN THIS VERY MUCH TO
HEART.
I WOULD LIKE TO SHARE 1 EXAMPLE.
YOU SEE DOWN HERE IN THE BOTTOM
LEFT OF THE SLIDE, CC-DIRECT
WHICH STANDS FOR NCI'S NEW
CHILDHOOD CENTER FOR DATA
INTEGRATION AND RESEARCH
EDUCATION AND CARE AND CLINICAL
TRIALS.
CC-DIRECT.
IT'S A BIG DEAL FOR 2 REASONS.
FIRST IT IS THE FIRST OF ITS
KIND PUBLIC PRIVATE PARTNERSHIP
THAT WILL DIRECTLY HELP FAMILIES
FACING CHILDHOOD CANCER.
NEXT SLIDE, PLEASE.
SPECIFICALLY, IT WILL HELP
FAMILIES WITH THE CHILD THAT HAS
CANCER OBTAIN THEIR CHILD'S
MEDICAL RECORD AND IF NEEDED
ALSO CONNECT THE FAMILY AND
CHILD TO EXCELLENT SPECIALTY
CARE.
DIRECT CONCERN AND CARE FOR
PATIENT AND FAMILY.
IT WILL ALSO PROVIDE THEM WITH
THE OPPORTUNITY TO PARTICIPATE
IN RESEARCH THROUGH CLINICAL
TRIALS AND OTHER DATA SHARING
INITIATIVES.
CC-DIRECT HITS AT THE VERY HEART
OF THE REIGNITED MOON SHOT
BECAUSE ITS GOAL IS TO PROVIDE
EVERY FAMILY AND CHILD WITH MUCH
NEEDED SUPPORT SO THAT THEY CAN
SUCCESSFULLY NAVIGATE A VERY
COMPLEX HEALTHCARE SYSTEM AT A
TIME OF GREAT PERSONAL STRESS.
AND ALSO MAKE SURE THAT THEY ARE
NOT LEFT OUT OF OPPORTUNITIES
FOR RESEARCH.
FOR EXAMPLE, CC-DIRECT WILL
CENTRALLY COORDINATE A REQUEST
TO PARTICIPATE IN NCI'S
CHILDHOOD CANCER MOLECULAR
CHARACTERIZATION INITIATIVE, A
NATIONAL COLLABORATION THAT
PROVIDES STATE-OF-THE-ART TO
MOLECULAR CHARACTERIZATION AT
THE TIME OF DIAGNOSIS AND HELPS
PARTICIPANTS AND DOCTORS SELECT
THE BEST AND MOST APPROPRIATE
TREATMENT.
WHEN FULLY IMPLEMENTED CC-DIRECT
WILL LINK CHILDREN AND FAMILIES
TO MANY MORE RESOURCES AND
OPPORTUNITIES FOR RESEARCH
PARTICIPATION.
JUST THINK, HOW POWERFUL THIS
NAVIGATION AND ENGAGEMENT
PROGRAM WILL BE FOR THE
APPROXIMATELY 15% OF KIDS AND
ADOLESCENTS WHO CURRENTLY HAVE
REAL DIFFICULTY WITH CARE ACCESS
AND ALSO FOR CHILDREN WITH
PARTICULARLY RARE TUMORS WHO
NEED HIGHLY SPECIALIZED CARE AND
A STRAIGHT PATH TO GETTING THEM
THERE.
SO THE REASON FOR HIGHLIGHTING
THIS PROGRAM, IN PARTICULAR, IS
THAT IT ALSO REPRESENTS A GROUND
BREAKING RESPONSE TO THE CALL
FOR AN ALL OF SOCIETY APPROACH.
CC-DIRECT WAS NOT LAUNCHED WITH
CANCER MOONSHOT FUNDING.
INSTEAD IT IS A COLLABORATION
BETWEEN NCI AND THE 7 OTHER
ORGANIZATIONS LISTED ON THIS
SLIDE.
EACH OF THESE ORGANIZATIONS ARE
INVESTED IN THE TRUEST SENSE OF
THE WORD, CONTRIBUTING IN-KIND
SUPPORT TO MAKE THIS PROGRAM A
REALITY.
IT IS THIS BROAD BASED
INVESTMENT THAT WILL INSURE THE
PROJECT'S SUCCESS.
YOU WILL HEAR THIS RECURRING
THEME THROUGHOUT ALL OF OUR
WORK.
NCI CAN'T DO THIS ALONE.
WE NEED TO BE A HIGHLY EFFECTIVE
CONVENER AND PARTNER IN ORDER TO
ACHIEVE OUR GOALS.
NEXT SLIDE, PLEASE.
SO I JUST WANT TO ACKNOWLEDGE
THAT WE HAVE SOME NEW NCAB
MEMBERS, 6 NEW MEMBERS WERE
APPOINTED BY THE PRESIDENT LAST
WEEK, YOU SEE THEIR NAMES HERE,
EACH BRINGS VERY IMPORTANT NEW
EXPERTISE TO NCAB AND WE LOOK
FORWARD TO WORKING WITH THEM.
I UNDERSTAND THEY'RE NOT YET
FULLY ONBOARDED AND SO, IN THE
INTEREST OF TIME, WE WILL WAIT
TO HAVE A FORMAL INTRODUCTION AT
THE NEXT MEETING WHEN THEY WILL
BE FORMALLY JOINING US.
NEXT SLIDE, PLEASE.
SO, STATE OF THE UNION, EARLIER
THIS WEEK, PRESIDENT GAVE HIS
STATE OF THE UNION ADDRESS AND
IN IT HE SAID: WILL BE A TRULY
AMERICAN MOMENT THAT RALLIES THE
COUNTRY AND THE WORLD TOGETHER
AND PROVES WE CAN STILL DO BIG
THINGS.
LET'S END CANCER AS WE KNOW IT,
CURE SOME CANCERS ONCE AND FOR
ALL.
WE HAVE OUR MARCHING ORDERS FROM
OUR COMMANDER IN CHIEF AND WE
ARE RARING TO GO.
NEXT SLIDE, PLEASE.
WE GOT SOME GOOD NEWS FROM
CONGRESS IN DECEMBER, ON THE
29th PRESIDENT BIDEN SIGNED
LEGISLATION THAT PROVIDED
FUNDING FOR NCI, NIH AND OTHER
FEDERAL AGENCIES
SEPTEMBER 30th, 2023 AND
CONGRESS ONCE AGAIN DEMONSTRATED
ITS DEEP CONCERN FOR PEOPLE WITH
CANCER AND STRONG COMMITMENT TO
NCI RESEARCH WE RECEIVED A
BUDGET INCREASE OF 408 MILLION,
THAT'S A 386 MILLION INCREASE TO
OUR BASE BUDGET, AND A
22 MILLION INCREASE TO THE FINAL
YEAR OF CANCER MOONSHOT 1.0
FUNDING WHICH MEANT WE HAD A
TOTAL OF $216 MILLION IN CANCER
MOONSHOT FUNDING.
THIS BASE INCREASE MAKES IT
POSSIBLE TO FUND MORE COMPELLING
INVESTIGATOR INITIATED CANCER
RESEARCH AND TO CONTINUE TO
SUPPORT KEY RESEARCH EFFORTS
OUTSIDE OF THE RPG POOL, LIKE
OUR CLINICAL TRIALS NETWORKS,
CORE SUPPORT FOR NCI DESIGNATED
CANCER CENTERS, TRAINING AND
MORE.
WE SHARED SPECIFICS ABOUT OUR
PAY LINES AND THE MOST RECENT
BOTTOM LINE POST, HERE ARE SOME
OF THE DETAILS.
THE RESEARCH PROGRAM GRANT POOL,
IT IS RPG FUNDING THAT ALLOWS
INVESTIGATORS, I THINK--LET'S GO
TO THE NEXT SLIDE, PLEASE--THAT
ALLOWS INVESTIGATORS THROUGH THE
ENTIRE CANCER RESEARCH
ENTERPRISE TO TURN THEIR
INNOVATIVE NEW IDEAS INTO
ANSWERS THAT DRIVE PROGRESS FOR
OUR PATIENTS.
PEER REVIEW, SETS A PRIORITY
LEVEL FOR FUNDING FOR THE
THOUSANDS OF PROPOSALS RECEIVED
AND THE PAY LINE DICTATES THE
NUMBER OF GRANTS THAT THE NCI
BUDGET SUPPORTS.
THE BIG NEWS HERE, IS THAT FOR
2023, WE WERE ABLE TO INCREASE
THE RO-1 PAY LINE TO THE 12th
PERCENTILE.
COMPARED TO THE 11th
PERCENTILE IN 2022, THIS
CONTINUES THE SUSTAINED PAY LINE
INCREASES WE'VE BEEN ABLE TO
MAKE SINCE 2019 WHEN THE PAY
LINE WAS AT THE EIGHTH
PERCENTILE.
HERE AIAN FACT FOR YOU.
--HERE'S A FACT FOR YOU: THE
LAST TIME THAT THE RPG PAY LINE
WAS 12% OR HIGHER WAS IN 2010.
SO WE ARE NOW AT A 13 YEAR HIGH,
NOT AS HIGH AS WE WANT BUT A 13
YEAR HIGH IN OUR ABILITY TO FUND
THESE VERY IMPORTANT GRANTS.
WE ALL RAISED THE PAY LINE FOR
EARLY STAGE INVESTIGATORS TO THE
17th PERCENTILE, UP 1% AND
THESE--TOGETHER THESE PAY LINE
INCREASES AS WELL AS SOME OTHERS
WILL FUND MORE THAN A HUNDRED
ADDITIONAL RO-1 AND ESI AWARDS
THAN LAST YEAR.
THROUGH THESE DECISIONS WE HAVE
REAFFIRMED OUR COMMITMENT TO
DISTRIBUTING FEDERAL FUNDING TO
RESEARCHERS WHOSE WORK SO
SUCCESSFULLY ESTABLISHES THE
FOUNDATION FOR PROGRESS IN
CANCER PREVENTION TREATMENT AND
CONTROL.
NEXT SLIDE.
I KNOW YOU ALL PROBABLY SEEN
THIS SLIDE ON THE WEBSITE.
IT'S A CHALLENGE, IT'S AN
ILLUSTRATION OF THE CHAL ENK WE
FACE EVERY TIME WE RAISE THE PAY
LINE.
IT MEANS THAT DUE TO OUTYEAR
COSTS INCURRED BY EACH INCREASE,
WE NEED TO SEE AN INCREASE IN
OUR FUNDING IN THE YEARS THAT
FOLLOW TO MAINTAIN THAT PAY LINE
AND TO PAY FOR THE GRANTS THAT
WE'VE ALREADY FUNDED.
WE HAVE OTHER IMPORTANT
COMMITMENTS THAT ARE FUNDED
OUTSIDE THE RPG POOL, SO JUST
THE NATIONAL CLINICAL TRIALS
NETWORK, NCOR, THE COMPREHENSIVE
CANCER CENTERS, GLOBAL HEALTH
AND PROGRAMS LIKE THE RAS
INITIATIVE AND WE NEED TO
ADDRESS THE RISING COSTS OF
CONDUCTING BIOMEDICAL RESEARCH
OVERALL.
THAT MEANS WE NEED SIGNIFICANT
INCREASES IN BUDGETS IN
SUBSEQUENT YEARS IN ORDER TO BE
ABLE TO COVER THOSE OUTYEAR
COSTS AND MAINTAIN OUR SUPPORT
FOR NEW RO-1S.
EVEN THIS YEAR, WITH A
408 MILLION-DOLLAR INCREASE,
RISING COSTS MEANT THAT TO
INCREASE THE PAY LINE, WE TO PAY
MOST CONTINUING NONCOMPETING
GRANTS.
THAT IS YEARS 2-5 OF A TYPICAL 5
YEAR GRANT AT 98%.
NOT THE FULL AMOUNT.
WE ALSO CONSIDERABLY TIGHTENED
OUR BELTS AT NCI ONCE COVERING
INCREASED BASE LINE COSTS, WE
ALSO HAD OUR DIVISIONS, OFFICES
AND CENTERS TAKE A 2% CUT AND WE
ALLOCATED FOR A GREAT AMOUNT OF
THE NEW FUNDING TO CRITICAL
INFRASTRUCTURE NEEDS THAT WE
JUST CAN'T DELAY, SUCH AS
INFORMATION TECHNOLOGY THAT WILL
FURTHER EXPAND DATA SHARING
ACCESS ACROSS THE ENTIRE
RESEARCH COMMUNITY.
THIS IS A BIG PRIORITY FOR US
AND FOR OUR COMMUNITY.
AND WE USED SOME OF THIS YEAR'S
EXTRA FUNDING TO MAKE SURE IT IS
SUPPORTED.
MISS HOLOHAN WILL PRESENT MORE
ON THIS AND WHAT THAT COULD MEAN
FOR OUR SESSION, NEXT SLIDE.
LAST TIME I MENTIONED THE
NATIONAL CANCER PLAN, NCI LEADS
A NATIONAL CANCER PROGRAM
REQUIRED BY THE NATIONAL CANCER
ACT OF 1971 THAT CALLS FOR
COLLABORATION ACROSS LOCAL,
FEDERAL AND STATE GOVERNMENTS,
ALL OF THE MANY AGENCIES,
ORGANIZATIONS, AND OTHER GROUPS
THAT PLAY A ROLE IN OUR PROGRESS
AGAINST CANCER.
THAT IS THE REASON THAT WE ARE
NOW CREATING A NATIONAL CANCER
PLAN.
THIS IS DIFFERENT FROM THE
ANNUAL PLAN AND BUDGET THAT NCI
RELEASES EVERY YEAR WHICH WE USE
TO CALL THAT ANNUAL PLAN IS USED
TO FOCUS ATTENTION ON PROMISING
NEW NCI REPORTED RESEARCH AND
AREAS THAT YEAR AND PROVIDE OUR
BEST PROFESSIONAL JUDGMENT ON
THE FUNDING NEEDED OVER THAT
FISCAL--THE FISCAL YEAR THAT
FOLLOWS.
INSTEAD, THE NATIONAL CANCER
PLAN IS A LONG RANGE PLANNING
DOCUMENT, 1 THAT WILL GUIDE OUR
WORK FOR YEARS.
IT IS THE RESPONSE TO THE
CHALLENGE THAT WE REDUCE CANCER
MORTALITY BY 50% IN 25 YEARS.
AN ANNUAL PLAN WILL NOT GET US
THERE, WE NEED LONG RANGE
PLANNING.
AND ALSO NEED IT TO END CANCER
AS WE KNOW IT.
WE WILL CONTINUE WITH OUR ANNUAL
PLAN TO ALIGN AND FOCUS OUR
PRIORITIES WITHIN A GIVEN YEAR,
BUT NOW, I WOULD LIKE TO GIVE
YOU AN UPDATE ON WHERE WE ARE
WITH THE NATIONAL BROADER,
LONG-TERM NATIONAL CANCER PLAN
TODAY.
OVER THE LAST COUPLE MONTHS,
I'VE WORKED VERY CLOSELY WITH
NCI LEADERS TO PUT TOGETHER THE
PLAN.
IT EMBRACES THE IDEA THAT
EVERYONE HAS A ROLE TO PLAY,
ACROSS FEDERAL AGENCIES AS WELL
AS INDUSTRY, UNIVERSITIES,
ADVOCACY GROUPS, NONPROFITS,
EVEN CAREGIVERS AND PATIENTS.
OUR INTENT IS THAT WHEN ANY
ORGANIZATION OR PERSON LOOKS AT
THIS PLAN, THEY WILL SEE WHERE
THEY FIT AS A CONTRIBUTOR TO
PROGRESS AND THEY WILL ALSO BE
ABLE TO SEE THE FULL PICTURE OF
THE MANY INTERRELATED ACTIONS
NEEDED TO END CANCER AS WE KNOW
IT.
TO MAKE SURE THAT THIS PLAN
REALLY WORKS FOR EVERYONE, AND
NOT JUST NCI, WE'RE GETTING--NOW
GETTING INPUT FROM A WIDE RANGE
OF STAKEHOLDERS ACROSS NIH, THE
DEPARTMENT OF HEALTH AND HUMAN
SERVICES, THE WHITE HOUSE,
OFFICE OF SCIENCE AND TECHNOLOGY
POLICY, THE CANCER CABINET, AND
VARIOUS OTHER ORGANIZATIONS AND
GROUPS.
WE WILL DISCUSS THE PLAN IN
DETAIL WITH YOU OF COURSE VERY
SOON SO THAT YOU CAN PROVIDE
YOUR INPUT.
ONCE WE FINALIZE IT, THE PLAN
WILL BE COMMUNICATED TO THE WIDE
PUBLIC THROUGH OUR WEBSITE,
SOCIAL MEDIA, OUR PARTNERS, NEWS
OUTLET AND NEWS OUTLETS AND AT A
VARIETY OF EVENTS.
WE WILL START THIS SPRING AND
CONTINUE THROUGHOUT THE YEAR SO
IT'S COMING VERY SOON.
FINALLY, NOTHING IN THIS PLAN
WILL SURPRISE YOU.
I MEAN, OF COURSE, AS MEMBERS OF
THE NCAB, YOU ARE ALL ACUTELY
AWARE OF EVERYTHING THAT WE NEED
TO DO TO END CANCER AS WE KNOW
IT, BUT IT IS INTENDED TO COVER
ALL THE BASES AND IT ALSO
INCLUDES MANY GOALS THAT HAVE
ALREADY BEEN ARTICULATED BY YOU
AND OTHERS, BY THE PRESIDENT,
THE BLUE RIBBON PANEL OF THE
FIRST CANCER PANELS OF THE
CANCER MOONSHOT, THE PRESIDENT'S
CANCER PANEL AND BY YOU ALL.
WHAT THIS DOES IS PUT ALL OF
THESE IMPORTANT GOALS AND
OBJECTIVES INTO A FRAMEWORK THAT
WILL HELP US SEE THE FULL RANGE
OF WHAT IS NECESSARY, BE ABLE TO
STRATEGIZE AND MOST IMPORTANT
WORK TOGETHER.
NEXT SLIDE.
SO WHATEVER THE FUTURE HOLDS FOR
OUR BUDGET, NCI CONTINUES ITS
IMPORTANT WORK MAKING BEST USE
OF WHATEVER RESOURCES WE HAVE
TODAY.
AND I WOULD LIKE TO GIVE YOU A
FEW HIGHLIGHTS.
THESE EXAMPLES WERE CHOSEN TO
REPRESENT PARTICULAR AREAS OF
FOCUS, THE FIRST INVOLVES
CLINICAL TRIALS.
AS WE CONVEYED IN OUR 2024
ANNUAL PLAN AND BUDGET, WE NEED
AT A MIN NUM TO DOUBLE ACCRUAL
TO CLINICAL TRIALS, TO PRODUCE
THE PREVENTION, DETECTION AND
TREATMENT MEASURES THAT WILL END
CANCER SUFFERING.
WE JUST DON'T HAVE ENOUGH PEOPLE
PARTICIPATING IN TRIALS TO MAKE
THE RAPID PROGRESS WE NEED AND
THOSE WHO HAVE BEEN UNDERSERVED
AS NOT BEEN ABLE TO BENEFIT FROM
TRIALS THE SAME AS THOSE WHO
HAVE BEEN ABLE TO PARTICIPATE.
SO WE NEED TO MAKE IT POSSIBLE
FOR EVERY SINGLE PERSON WITH
CANCER OR AT RISK FOR CANCER TO
HAVE A REALISTIC OPPORTUNITY TO
PARTICIPATE IN RESEARCH EMPHASIS
ON REALISTIC.
AND WE NEED TO THINK
DIFFERENTLY.
WE JUST HAVEN'T GONE FAR ENOUGH
TO MAKE CLINICAL TRIALS EASY FOR
PEOPLE TO PARTICIPATE IN SO THAT
WE CAN GET RESULTS MUCH FASTER.
LAST JULY, A NEW TRIAL WAS
CONCEIVED TO DO EXACTLY THIS,
LAST JULY.
WHAT EMERGED NOW IN FEBRUARY,
THAT'S PRETTY QUICK TIMELINE, IS
THE TRIAL FOR PEOPLE WITH LUNG
CANCER, THE PRAGMATIC TRIAL
WHICH IS A COLLABORATION BETWEEN
NCI, NATIONAL CLINICAL TRIALS
NETWORK, FDA, LILLY, MERK, AND
THE LUNG MAP INVESTIGATORS, THE
RESEARCH QUESTION IS WHETHER THE
COMBINATION OF RAMUCIRUMAB, PLUS
PEMBRLIZUMAB VERSUS STANDARD OF
CARE FOR PARTICIPANTS PREVIOUSLY
TREATED WITH IMUGOLOGY WHOSE
DISEASE PROGRESSED AFTER
IMMUNOTHERAPY.
A VERY STRAIGHT FORWARD
REGISTRATION TRIAL WAS DESIGNED
TO DEEMERGING IF THIS DRUG
COMBINATION HELPS THESE PATIENTS
LIVE LONGER.
THE TEAM PULLED OUT ALL THE
STOPS AND SHOWED THAT A TRIAL
COULD BE VERY QUICKLY DEVELOPED,
WHAT MADE ALL THE DIFFERENCE WAS
THE WILLINGNESS OF ALL PARTIES,
GOVERNMENT, INDUSTRY, AND
ACADEMIC COLLABORATORS TO WORK
TOGETHER AND ELIMINATE ALL OF
THE DELAYS THAT NORMALLY
CHALLENGE MULTISTAKEHOLDER
COLLABORATIONS.
AND NOW WE'RE READY TO OPEN THIS
SIMPLE BUT VERY IMPORTANT TRIAL
ACROSS THE NATION AND FOCUS ON
RAPIDLY ENGAGING PATIENTS
PARTICULARLY THOSE WHO ARE TOO
OFTEN LEFT OUT OF CLINICAL
TRIALS, THOSE WITH ADVERSE
SOCIAL DETERMINANTS OF HEALTH
WHO ARE ALSO THE PEOPLE AT
GREATEST RISK FOR SMALL CELL
LUNG CANCER IN THE FIRST PLACE.
SO THE NEXT STEP IS TO MAKE THIS
KIND OF INNOVATION, INCLINICAL
TRIALS DESIGN AND OPERATIONAL
EFFECTIVENESS COMMON PLACE.
TO DO THIS, I AM DELIGHTED TO
ANNOUNCE THAT IN COLLABORATION
WITH FDA, AND THE EXTRAMURAL
CANCER CLINICAL RESEARCH
COMMUNITY, WE HAVE CREATED A
CLINICAL TRIAL INNOVATION UNIT.
THIS UNIT IS NOT INTENDED TO
REPLACE THE CURRENT VERY ACTIVE
AND CRITICAL STUDY DESIGN AND
APPROVAL PROCESSES OF THE
NATIONAL CLINICAL TRIALS
NETWORK, INSTEAD, THE UNIT WILL
SELECT HIGH PRIORITY STUDIES
DEEMED PARTICULARLY AMENABLE TO
RADICALLY NEW STUDY DESIGNS AND
OPERATIONAL PROCEDURES.
AND THEN, ENGAGE THE PARTNERS
NECESSARY TO BREAK THE MOLD AND
FORGE A NEW PATH.
VERY HARD TO DO THAT UNDER OUR
CURRENTLY VERY ACTIVE, IN OUR
CURRENT VERY ACTIVE MECHANISMS
FOR CLINICAL TRIAL DESIGN AND
APPROVAL.
THE UNIT WILL BE CO-DIRECTED BY
DR. SHEILA PRINDEVILLE, WHO IS
DIRECTOR OF NCI'S CLINICAL
COORDINATING CENTER FOR CLINICAL
TRIALS AND DR. MICHAEL MORRIS
FROM MEMORIAL SLOAN KETTERRING
CANCER CENTER, BOTH OF WHOM WILL
BE NONVOTING MEMBERS OF THE
UNIT.
AND I WILL EMPHASIZE, ALL
ASPECTS OF CLINICAL TRIALS ARE
ON THE TABLE.
STUDY ELIGIBILITY, COMPARATOR
ARMS, END POINTS, DIAGNOSTICS
STUDY DATA COLLECTION
PROCEDURES, PARTICIPANT
ENGAGEMENT STRATEGIES,
EVERYTHING, THAT CAN BE ADAPTED
TO ACHIEVE MORE AND FASTER
BENEFIT FOR PATIENTS, IS OPEN TO
INNOVATION.
WE ANTICIPATE THE SUCCESSFUL
APPROACHES DEVELOPED BY THIS
UNIT WILL THEN TRANSITION TO
BECOME MAIN STREAM BUT THAT THE
NEED FOR INNOVATION WILL ALWAYS
CONTINUE AND I'M VERY HAPPY TO
TELL YOU THAT THIS UNIT WILL
BEGIN ITS WORK THIS MONTH.
THE OTHER AREA I WOULD LIKE TO
HIGHLIGHT INVOLVES DATA.
WE WON'T IMPROVE OUR
UNDERSTANDING OF CANCER BIOLOGY
AND WHAT MEASURE WORKS BEST
AGAINST IT WITHOUT DATA.
ESPECIALLY PRACTICES POPULATIONS
LONG UNDER REPRESENTED IN OUR
DATA COLLECTIONS.
WE'RE MAKING GREAT HEAD WAY TO
GET MUCH NEEDED DATA INTO THE
HANDS OF SCIENTISTS.
YOU ALL KNOW HOW CHALLENGING AND
FRANKLY COSTLY THIS IS.
I'M TRULY EXCITED ABOUT THE
CHILDHOOD CANCER DATA
INITIATIVE, CCDI, YOU SEE IT ON
THE TOP RIGHT.
ITS PROGRESS, IT'S MADE
TREMENDOUS PROGRESS TO PROVIDE
DATA THAT HAS HISTORICALLY BEEN
VERY CHALLENGING FOR RESEARCHERS
TO ACCESS, THIS YEAR GREG
[INDISCERNIBLE] WHO HAS TAKEN
CHARGE OF CCDI, HAS TAKEN TIME
AND LEADING THE CHILDREN'S
ONCOLOGY GROUP AND ALSO WORKING
AT FDA, IN DECEMBER THE CCDI
MOLECULAR TARGETS PLATFORM,
WHICH IS A TOOL THAT CATALOGS
AND CHARACTERIZES, MOLECULAR
EVENTS INVOLVED IN THE GROWTH
AND SPREAD OF CHILDHOOD CANCERS
WAS UPDATED WITH ADDITIONAL DATA
AND SOFTWARE, AND IN JANUARY,
THE CHILDHOOD CANCER DATA
CATALOG ADDED 5 NEW RESOURCES, 3
ANALYTICAL TOOLS AND 46 NOW DATA
SETS.
ON MARCH 24th, NCI WILL HOST
AN ANNUAL SYMPOSIUM WHICH WILL
GATHER EXPERTS FROM AROUND THE
COUNTRY TO DISCUSS CCI'S
PROGRESS, HIGHLIGHT THE NEW
RESOURCES AVAILABLE TO THE
BROADEST POSSIBLE COMMUNITY AND
DISCUSS OPPORTUNITIES FOR THE
FUTURE.
THERE'S A LOT MORE TO COME IN
THE VERY NEAR FUTURE THROUGH
THIS TRANSFORMATIVE PROGRAM THAT
PROVIDES A FIRST OF THE KIND
PLATFORM FOR NATIONWIDE DATA
SHARING AND RESEARCH
COLLABORATION ON BEHALF OF
CHILDREN AND ADOLESCENTS IN
YOUNG ADULTS WITH CANCER.
NEXT COMMENT, WE'RE CELEBRATING
THE 50th ANNIVERSARY OF
SURVEILLANCE, EPIDEMIOLOGY AND
END RESULTS PROGRAM OR SEER.
SEER IS AN INDENSE PENNIBLE TOOL
IN THE FIGHT AGAINST CANCER.
IT COVERS ALMOST HALF THE
POPULATION THROUGH PARTICIPATING
CANCER REG TREES AND AN
ANNOUNCEMENT OF SEER DATA
PROVIDES US WITH OUR REPORT
CARD, TELLS US WHERE WE STAND
WITH VARIOUS CANCERS BY POWERING
IMPORTANT REPORTS LOAMACYIC THE
CANCER TRENDS PROGRESS REPORT
AND THE ANNUAL REPORT TO THE
NATION ON THE STATUS OF CANCER.
THROUGHOUT THE REST OF THE YEAR,
YOU WILL SEE A SERIES OF
INFORMATION ON SEER'S
CONTRIBUTION TO CANCER RESEARCH
AND PUBLIC HEALTH ONLINE, ON
SOCIAL MEDIA AND AT VARIOUS
EVENTS.
I WILL REMIND YOU SEER CAN DO
MORE.
WE CAN EXPAND AND FURTHER
EMPOWER SEER TO GO BROADER,
COVER EVEN MORE AND HELP US
REALLY ADDRESS THE NEEDS OF OUR
UNDERREPRESENTED POPULATION.
THIS IS SOMETHING THAT--A GOAL
TO WHICH WE ASPIRE.
NEXT SLIDE, PLEASE.
THE BEST NEWS I CAN SHARE IS
THAT NCI KEEPS PRODUCING THE
KIND OF RESULTS WE REALLY NEED.
SO WE STILL HAVE A LOT MORE
PROGRESS TO MAKE A LOT MORE
PROGRESS IN HOW WE TREAT AND
PREVENT CANCER.
WE MADE IMPORTANT PROGRESS EVEN
SINCE OUR LAST MEETING IN
DECEMBER.
SO I THOUGHT I WOULD SHARE
HIGHLIGHTS.
ON THE TREATMENT SIDE, IN 2021,
WE SAW THE FIRST FDA APPROVAL
FOR KRAS, FOR TUMORS WITH KRAS
MUTATIONS THAT WAS THE G12
C-MUTATION WHICH IS THE MOST
COMMON IN LUNG CANCER.
WE MAY BE NOW, ON THE PATH TO A
TREATMENT FOR G12 D-MUTATIONS.
COMMON IN PANCREATIC CANCER
WHICH HAS BEEN A REAL STRUGGLE
FOR PATIENTS AND PROVIDERS
ALIKE.
AN NCI FUNDED STUDY SHOWED THAT
A NEW DRUG KNOWN AS MRTX1133,
SHRANK TUMORS OR HALTED THEIR
GROWTH WITH KRAS MUTATIONS.
WE EXPECT TO SEE THIS REALLY
EXCITING RESULT TRANSLATE INTO
HUMAN STUDIES.
NEXT, A PHASE 2 TRIAL LED BY
NCI'S DIVISION OF CANCER
TREATMENT AND DIAGNOSIS, RESULT
E
D IN THE FIRST FDA
TREATMENT OF ALVEOLAR SARCOMA
FOR ADULT ANDS CHILDREN 2 YEARS
AND OLDER, ATIZALUZAMAB.
NEXT FOR A SERIES OF
COLLABORATIONS BETWEEN THE
AMERICAN SOCIETY OF CLINICAL
ONCOLOGY WAS PUBLISHED IN JCO
ONCOLOGY PRACTICE.
I URGE YOU TO TAKE A ELECTRIC AT
THIS.
IT INCLUDED 15 PEER REVIEWED
PUBLICATIONS ON THE TOPIC OF
TEAM BASED CANCER CARE.
THEY DESCRIBED SIGNIFICANTLY
INCREASED INVOLVEMENT OF ADVANCE
PRACTICE PROVIDERS IN CANCER
CARE, IN RESPONSE TO INCREASED
PATIENT DEMAND AND AN INADEQUATE
NUMBER OF ONCOLOGIST NUMBERS IN
OUR WORKFORCE AND INCREASING
COMPLEXITY.
ALSO WAS A INCREASE IN PARTIC
PLAN TO ANALYZE BY AGES
ROUTINELY PARTICIPATING IN AN
INDIVIDUAL PATIENT'S CARE
INCLUDING PHARMACISTS, ONCOLOGY,
NUTRITIONISTS, PALLIATIVE CARE
SPECIALIST, SOCIAL WORKERS,
NURSE NAVIGATORS AND MANY
OTHERS.
A BIG THEME THROUGHOUT THIS
SERIES IS THAT CANCER CARE IS
BECOMING INCREASINGLY COMPLEX
AND THAT UNDERSTANDING THE
DYNAMICS OF CANCER CARE DELIVERY
AT ALL LEVELS, IS REQUIRED FOR
SUCCESSFUL CLINICAL RESEARCH AND
ALSO FOR THE IMPLEMENTATION OF
NEW ADVANCES IN CANCER CARE AND
PREVENTION.
IN PREVENTION, A PHASE 1
CLINICAL TRIAL INVOLVED
RESEARCHERS FROM NCI'S CENTER
FOR CANCER RESEARCH AND THE
FREDERICK NATIONAL LAB AND
SHOWED THAT A COMBINATION DOSE
OF [INDISCERNIBLE] MAY BE
EFFECTIVE IN PREVENTING BRAIN
METASTASIS FOR PATIENTS WITH
HER-2 POSITIVE BREAST CANCER.
THIS STUDY OF--THIS STUDY SHOWED
THAT 83% OF PATIENTS
DEMONSTRATED NO NEW BRAIN
METASTASIS WITH TREATMENT AND WE
LOOK FORWARD TO SEEING THIS
IMPORTANT PHASE 1 RESULT MOVING
FORWARD.
FINALLY, WE KNOW THAT DRINKING
ALCOHOL CAN INCREASE THE CANCER
RISK OF SEVERAL CANCER TYPES.
BUT ANOTHER ILLUSTRATION OF HOW
WE NEED TO GET OUR KNOWLEDGE
TRANSLATED TO PEOPLE, NOT JUST
TO OTHER RESEARCHERS WAS A STUDY
LED BY NCI'S DIVISION OF CANCER
CONTROL AND POPULATION SCIENCES
FOUND THAT MOST PERSONS WEREN'T
AWARE OF THIS CONNECTION.
THEY CONCLUDED THAT NUMEROUS
CHANGES NEED TO BE MADE TO RAISE
PUBLIC AWARENESS OF THIS FACT
BECAUSE AND WE KNOW THAT
AWARENESS DOESN'T GUARANTEE
ACTION, WILL NEED FURTHER
RESEARCH TO SOLVE THESE
CHALLENGES.
NEXT SLIDE.
SO FINALLY, THANK YOU SO MUCH
FOR BEING HERE TODAY, THIS IS
JUST A BRIEF SNAPSHOT OF WHAT'S
GOING ON.
I KNOW THAT YOU ALL LEAD VERY
DEMANDING LIVES AND WE SINCERELY
APPRECIATE THE EXPERTISE THAT
YOU CONTRIBUTE TO HELP NCI
ACHIEVE ITS MISSION.
FINALLY, A PERSONAL NOTE OF
THANKS TO ALL OF YOU WHO REACHED
OUT WITH YOUR EXPRESSIONS OF
SUPPORT DURING MY OWN RECENT
CANCER DIAGNOSIS.
MY TREATMENT IS GOING VERY WELL,
OF COURSE, WE ALL HAVE TO BE
VERY HUMBLE IN THE FACE OF THIS
DISEASE BUT THANKS TO EARLY
DETECTION AND THE KNOWLEDGE
PROVIDED BY DECADES OF NCI
SUPPORTED RESEARCH, MY OWN
PERSONAL LONG-TERM PROGNOSIS IS
EXCELLENT.
I'M VERY GRATEFUL TO NCI
RESEARCHERS.
I LOOK FORWARD TO YOUR
QUESTIONS.
BACK TO YOU DR. CARPTEN.
>>THANKS MONICA, THAT'S
OUTSTANDING AND THANKS FOR
SHARING ALL THAT INFORMATION.
I WILL OPEN THE FLOOR FOR
QUESTIONS FOR THE DIRECTOR.
I GUESS I, I WILL START, WE HAVE
PROBABLY I THINK 10-12 MINUTES
FOR Q&A.
SO, I THINK, YOU KNOW 1 OF THE
THINGS THAT HAS COME UP, I THINK
WE'RE ALL SEEING IT MORE AND
MORE, SOME DECISIONS AROUND
PROSTATE CANCER SCREENING AND
YOU KNOW RECENT ARTICLES SHOWING
THERE'S A SIGNIFICANT INCREASE
IN ADVANCED PROSTATE CANCER AND
SO, WHAT ARE YOUR THOUGHTS,
RIGHT?
HOW DOES THE NCI GET INVOLVED IN
MITIGATING THIS SITUATION?
AND I UNDERSTAND SO THERE'S THE
PLAN AND THERE'S SORT OF THE
LONG-TERM GOALS OF SORT OF
ADVANCING NCI STRATEGICALLY BUT
THEN WHEN WE SEE THINGS LIKE
THIS HAPPEN, RIGHT, HOW DOES THE
NCI JUMP IN, RIGHT, AND GO INTO
LIKE WARP SPEED MODE, LET'S CALL
IT THAT, TO REALLY TRY TO FIGURE
OUT HOW WE MITIGATE THESE TYPES
OF SITUATIONS?
>>YEAH, I LOVE THIS QUESTION
BECAUSE IT ILLUSTRATES, YOU
KNOW, WE HAVE TO ATTACK IT AT
ALL LEVELS.
OKAY?
SO YOU KNOW, FIRST OF ALL,
THAT'S WHY WE NEED OUR REPORT
CARD, THAT'S WHY WE NEED TO KNOW
WHAT'S HAPPENING ON A POPULATION
LEVEL, ABSOLUTELY CRITICAL THAT
WE CONTINUE TO GET THAT
FEEDBACK, AND GET GOOD FEEDBACK
THAT SHOWS US WHICH
SUBPOPULATIONS, WHICH AS YOU
KNOW WELL, ARE A REAL--ALSO A
REAL SPECIFIC CONCERN IN
PROSTATE CANCER.
YOU KNOW WHERE WE REALLY NEED TO
FOCUS OUR ATTENTION AND THEN WE
ATTACK IT WITH THE SAME 3
PRONGED ATTACK THAT WE ALWAYS
DO, UNDERSTANDING THE BASIC
MECHANISMS OF EARLY TUMOR
DEVELOPMENT, NEXT, TRANSLATING
THAT UNDERSTANDING INTO
EFFECTIVE NEW METHODS FOR
DETECTION.
I MEAN I KNOW WE ALL HAVE EYES
ON THE NEW MOLECULAR
MULTICANCKER DETECTION TESTS;
YOU KNOW WHO KNOWS FOR PROSTATE
CANCER WE MAY NEED A VERY
SPECIFIC PROSTATE CANCER
MOLECULAR DETECTION TEST, WE
DON'T KNOW THAT WE WILL NOT
ASSUME, SO WE WILL TAKE THAT
BIOLOGY USE IT TO DEVELOP
DETECTION AND DIAGNOSTICS AND
THEN WE HAVE TO TAKE THAT AND
TRANSLATE IT INTO EFFECTIVE
PREVENTION AND PREVENTION BUT
WHEN NECESSARY, WHICH WILL
ALWAYS BE NECESSARY TREATMENT
APPROACHES, YOU KNOW AND SO I'M
NOT GOING TO SPEAK TO ALL THE
DETAILS BUT YOU KNOW YOU RALLY
THE COMMUNITY, YOU MAKE SURE
YOU'RE NOT ATTACKING THE PROBLEM
FROM ANY 1 LENS.
OH, GHEES, I FORGOT THE VERY
LAST 1 AND PROBABLY THE MOST
IMPORTANT WONGS WE HAVE
STRATEGIES FOR WHAT WE KNOW
WORKS, THEN WE NEED TO MAKE SURE
IT HAPPENS.
WE NEED TO MAKE SURE THAT THE
PEOPLE WHO NEED THE NEW
SCREENING METHODS OR PREVENTION
METHODS OR TREATMENT METHODS
ACTUALLY RECEIVE THEM.
SO YOU KNOW THAT APPROACH,
SOMETHING LIKE THIS, HAS TO BE
ATTACKED AT ALL LEVELS BY REALLY
DEDICATED ANDA FAINKLY I HEARD
THIS IN THE SUBCOMMITTEE REPORT
THIS MORNING AND BOY DID IT
RESONATE WITH ME, YOU DON'T
INVITE THE PREVENTION
RESEARCHERS TO THE TABLE ONLY
AFTER YOU KNOW SOMEBODY HAS
DECIDED EVERYTHING THEY KNOW
ABOUT THE MOLECULAR BIOLOGY OR
EVERYTHING THEY KNOW ABOUT THE
TREATMENT.
YOU NEED TO LET EVERYBODY IN ALL
THE TIME.
I'M A HUGE BELIEVENER CROSS
FERTILIZATION OF ALL THESE
DIFFERENT DISCIPLINES THAT ARE
REQUIRED TO GET US TO THE FINISH
LINE.
>>THANKS MONICA AND AGAIN, YOU
KNOW BLURT OUT THE WORD
INTEGRATION AND I THINK THE
OTHER THING WE HAVE TO THINK
ABOUT IS RISK.
I THINK SOME OF THE MOST--I
WOULD SAY THE DEEPEST
INFORMATION ON UNDERSTANDING
GENERATED ETDIC RISK AND
CANCER---GENETIC RISK AND CANCER
AND THERE'S BEEN TONS OF WORK
AROUND THAT AND HOW DO WE
INTEGRATE THESE 2 MODEL.
I SEE HANDS AND I WILL START
WITH ALEXIA AND THEN I WILL GO
TO ANN.
>>THANK YOU VERY MUCH.
THANK YOU MONICA THAT WAS A
WONDERFUL REPORT AND THANKS FOR
ALL YOU DO AND THE EXCITEMENT
AND ENERGY THAT YOU'RE BRINGING.
IME SO GLAD YOU'RE DOING WELL,
ALSO.
SO I HAVE TO COMMENTS.
FIRST OF ALL, WE ARE NOT AS A
NATION BOUNCING BACK FROM COVID
IN TERMS OF CANCER SCREENING AND
UPTICK OF HPV VACCINE.
WE JUST HAD AN ARTICLE PUBLISHED
IN JCO THE OTHER DAY THAT
QUANTIFIES SOME OF THAT AT LEAST
HERE AND I'M EXTREMELY CONCERNED
AS HAS BEEN ECHOED BEFORE, THE
CANCER STATISTICS REPORT SHOWED
A 65% DECREASE IN CERVICAL
CANCER INCIDENTS IN THE FIRST
COHORT OF WOMEN THAT GOT THAT
VACCINE THAT IS TREMENDOUS,
TREMENDOUS SHOWING WE CAN
PREVENT CANCER BUT I DON'T THINK
THAT'S SUSTAINED AND WE KNOW
THAT THAT HAS DECREASED SINCE
COVID.
SO, I THINK THAT HAS TO BE AT
THE FOREFRONT.
THERE ARE TESTS WE KNOW WORK AND
WE'VE GOTTA INCREASE THEIR
UPTAKE.
THE SECOND POINT, I LOVE THIS
CLINICAL TRIAL INNOVATION UNIT.
COULD I JUST MAYBE SUGGEST THAT
WHEN YOU'RE TALKING ABOUT
INNOVATIVE METHODS THAT A ALSO
FOCUS ON INNOVATIVE STRATEGIES
TO INCREASE ACCRUAL UNDER
REPRESENTED MINORITIES TO
TRIALS.
YOU KNOW, THERE ARE THINGS THAT
WE CAN DO, WE SHOULD BE DOING
AND WE'RE NOT DOING.
AND THIS INNOVATION UNIT WOULD
BE THE BEST--REALLY GREAT PLACE
TO FOCUS THAT, SO JUST COMMENTS
FOR CONSIDERATION, THANK YOU.
THANK YOU SO MUCH.
>>ALL RIGHT, AND MILO, I DID
SEE YOUR HAND.
>>GO AHEAD,.
>>NO, THANK YOU, ELECTRA, THANK
YOU AND I AGREE WITH YOUR
COMMENTS THERE.
THEY ARE VERY HIGH LEVEL
CONCERNS FOR US AND YOU KNOW WE
CAN NEVER FORGET, ON THE FIRST 1
WE CAN NEVER FORGET THAT WE
MIGHT KNOW WHAT'S THE RIGHT
THING TO DO OR REALLY BELIEVE IN
IT BUT IT'S GOT TO GET TO PEOPLE
OR WE'VE FAILED.
WE'VE FAILED.
AND WE'RE NOT--NCI'S NOT A CARE
DELIVERY ORGANIZATION BUT WE
BETTER BE DOING THE RESEARCH
THAT SHOWS HOW CARE DELIVERY CAN
BE ACCOMPLISHED IN WAYS THAT
ACHIEVE EQUITY AND MAXIMUM
UPTAKE OF WHAT WORKS.
>>OKAY, GREAT.
LET'S GO TO ANN AND THEN MILO,
AND THEN KAREN IF WE HAVE TIME
BECAUSE WE HAVE ABOUT 5 MINUTES
SO IF YOU CAN KEEP YOUR
QUESTIONS QUICK, THAT WOULD BE
GREAT.
>>SO MONICA JUST A QUICK
QUESTION.
THE PRESIDENT SAID SOMETHING A
COUPLE NIGHTS AGO THAT I'M
CONFUSED ABOUT AND I WONDER IF
YOU HAVE A BETTER IDEA, HE SAID
HE WANTS TO BRING CANCER
RESEARCH INFRASTRUCTURE INTO THE
21st CENTURY, DO YOU HAVE ANY
IDEA WHAT THAT MEANS?
I'M CURIOUS, WHAT YOU'RE
THINKING ABOUT THAT BECAUSE THAT
OPENS UP A WHOLE NEW WORLD IN
TERMS OF INFRASTRUCTURE AND I'M
JUST WONDERING, MAYBE
[INDISCERNIBLE] WILL KNOW MORE
ABOUT THIS THAN THE REST OF US
BUT USUALLY WE'RE NOT IN THE
INFRASTRUCTURE SENSE THAT WE'RE
BUILDING BUILDINGS, RIGHT--
>>WE HAVE A BUILDING--COUPLE
FLOODS AT OUR NIH BUILDING AND
WE WOULD LOVE TO SEE THAT
RADICALLY MODERNIZED.
NO, I HEAR YOU.
YOU KNOW I WILL TELL YOU WHAT IT
MEANS FOR ME AT NCI.
I THINK, YOU KNOW THE MOST RAPID
INCREASE IN DEMAND FOR
INFRASTRUCTURE FOR US HAS BEEN
INFORMATION TECHNOLOGY.
YOU KNOW INFORMATION TECHNOLOGY,
DATA, DATA STORAGE CAPABILITY,
DATAAN LYTICS, IT'S EXTENSIVE
PARADIGM AND DIFFICULT TO
INTEGRATE THE DATA SETS THAT WE
NEED SO, RIGHT THERE, THAT IS A
CRITICAL INFRASTRUCTURE NEED WE
HAVE THAT FRANKLY IS VERY
COSTLY.
YOU KNOW, 1 OF THE THINGS
THAT--YOU WILL HEAR ME SAY THIS
MANY TIMES.
WE HAVE UNBELIEVABLE INFORMATION
TECHNOLOGY AVAILABLE THAT'S OUT
THERE.
WE DON'T HAVE IT AVAILABLE THE
WAY IT NEEDS TO BE TO EVERY
SINGLE RESEARCHER.
SO THAT'S--IF YOU ASK ME WHAT
INFRASTRUCTURE DO YOU NEED WOB
THING THAT WILL BE FIRST ON MY
LIST IS INFORMATION DATA SHARING
TECHNOLOGY, ET CETERA AND I KNOW
HE SHARES THAT VIEW BECAUSE
THAT'S ALSO 1 OF HIS CENTRAL
THEMES AND FINALLY THE REASON I
WILL SAY IS THAT THE INFORMATION
THAT IS CRUCIAL IS BECAUSE WE
NEED IT TO WORK TOGETHER.
>>AS YOU KNOW THAT'S THE
PRESIDENT'S INTEREST IN MOON
SHOT 1 AND 2, BUT I THINK IT'S
GOTTEN THE EXECUTIVE BRANCH'S
ATTENTION THAT RGTD COUNTRIES
ARE INVESTING MORE IN SOME OF
THESE KEY AREAS AND WE BETTER
CATCH UP, WE BETTER NOT GET
BEHIND.
AND LAST CONGRATTULESS ON YOUR
WELL BEING, YOU'RE LOOKING
WONDERFUL BUT I NEED TO POINT
OUT SOMETHING THAT YOU KNOW
BREAST CANCER MORE THAN ANY
OTHER DISEASE HAS REALLY
RECEIVED SUPPORT FROM NCI IN SO
MANY DIFFERENT WAYS AND IT
REALLY SHOWS, AND IF YOU PUT THE
RESOURCES THERE, THINGS HAPPEN.
SO YOU'RE LOOKING GREAT.
>>THANKS.
GREAT.
SO LET'S NILO.
>>YEAH, I ALSO WANTED TO JUST
ASK A QUESTION ABOUT THE
CLINICAL TRIALS INNOVATION UNIT
WHICH SOUNDS VERY EXCITING BUT 1
OF THE THINGS THAT I THINK WOULD
BE GREAT IF IT COULD BE UNDER
ITS PERVIEW FOR EXPIRATION IS
THAT WE'RE NOW SEEING MORE
APPROVALS FOR BIOMARKER DRIVEN
DRUGS BASED ON VERY POWERFUL
RESPONSES IN SINGLE ARM STUDIES
BUT THEN THE FDA REQUIRES THESE
CONFIRMATION STUDIES THAT ARE
RANDOMIZED AND IN SMALL SUBSETS
OF PATIENTS AND THIS IS
PARTICULARLY TRUE IN SMALL
SUBSETS OF RARE TUMORS, THOSE
ARE NEARLY IMPOSSIBLE TO DO AND
ESPECIALLY TRUE IF WE HAVE
REDUNDANT DRUG DEVELOPMENT IN
THAT SPACE, SO IN
[INDISCERNIBLE] WHICH IS A
PARTICULAR SOFTMARRY FOR ME,
WE'VE JUST SEEN AN FGP INHIBITOR
PULLED FROM THE MARKET AFTER
APPROVAL BECAUSE THEY COULDN'T
GET IT DONE AND OTHERS ARE
PONDERING THIS AS WELL, SO I
LOLLED FOR THEM TO LOOK AT
INNOVATIVE WAYS TO GET THE
CONFIRMATION THEY NEED BUT
WITHOUT REQUIRING THESE
RANDOMIZED TRIALS THAT AREN'T
REASONABLE OR APPROPRIATE FOR
SMALL SUBSETS OF PATIENTS.
>>WELL, YOU HAVE--THANK YOU
VERY MUCH FOR THAT.
YOU HAVE JUST ARTICULATED A
PERFEBLGHT UNIT AND THE RIGHT
PEOPLE AROUND THE TABLE, IT'S
NCI, IT'S FDA AND IT'S THE
CLINICAL, THE EXTRAMURAL
CLINICAL TRIALS COMMUNITY.
SO THAT'S THE RIGHT TEAM TO TAKE
SOMETHING LIKE THIS ON, ALL OF
THEM TOGETHER, SO THAT'S A
PERFECT QUESTION TO BE BROUGHT
TO THIS NEW UNIT.
>>YEAH, THAT'S CLOSE TO MY
HEART TO, THE RARE CANCER SPACE,
AND WE WILL ENTERTAIN DR. WING
FIELD'S QUESTION.
>>THANK YOU JOHN, APPRECIATE
THAT.
HI, MONICA GOOD TO SEE YOU, I
LOVE THE IDEA OF THE CC-DIRECT.
I LOVE THAT.
NAVIGATING THESE ADOLESCENTINGS
THESE CHILDREN THROUGH THEIR
CANCER DIAGNOSIS ALONG WITH
THEIR FAMILIES, WOULDN'T THAT BE
LOVELY IF WE CAN GET THAT FOR
ALL OF OUR PATIENTS, 1 THING THE
PRESIDENT MENTIONED IN THE MOON
SHOT IS THIS CONCEPT OF HAVING
ALL HANDS ON DECK.
AND AS YOU KNOW 1 OF THE HUGEST
BARRIERS TO NOT ONLY CANCER
CARE, BUT PREVENTION AND ENTER
INTO CLINICAL TRIALS IS THAT THE
FACT WE DON'T HAVE A UNIFIED
INSURANCE AND HEALTHCARE SYSTEMS
THAT ALLOWS FOR PATIENTS FROM
UNDERSERVE BACKGROUNDS TO GET
ACCESS TO CARE, SO HAS THAT AT
ALL BEEN A TOPIC OF THE LARGER
GROUP THAT YOU KNOW OF IN TERMS
OF THINKING ABOUT HOW ALL PARTS
OF GOVERNMENT CAN BE HANDS ON
DECK, BECAUSE AGAIN IF WE LOOK
AT MEDICATE WITH A 30% PAYMENT,
IT REALLY DOES CAUSE AN
INFRASTRUCTURE CHALLENGE FOR
CANCER CENTERS THAT ARE
ACCEPTING MEDICAID SO I DON'T
KNOW WHAT SOME OF THAT
DISCUSSION WOULD BE AND I KNOW
WE DON'T HAVE TIME SO JUST VERY
QUICKLY TO SAY, I KNOW AND YOU
DO TOO THAT THIS IS VERY MUCH A
CONCERN OF THE PRESIDENT AND
ANDLET CANCER CABINET WHICH IS,
YOU KNOW WHICH IS ALL OF
GOVERNMENT, I CAN TELL YOU AT
NCI'S ROLE IS, WE HAVE--I CAN
TELL YOU, NOT MY JOB, NO, NO,
NO, WE HAVE A VERY IMPORTANT
ROLE.
WE BRING THE DATA THAT SHOWS,
HERE'S WHAT HAPPENS TO CANCER
DEATH RATES IN STATES THAT DO,
YOU KNOW THAT EXPAND MEDICAID.
WE BRING, WE HAVE TO BRING THE
DATA THAT JUSTIFIES WHY THIS
NEEDS TO HAPPEN AND I KNOW
THAT'S REALLY DIFFICULT WORK BUT
YOU KNOW THOSE WHO ARE TAKING
THAT ON ARE MAKING A GREAT
CONTRIBUTION AND THAT'S OUR JOB.
BRING THE DATA.
>>THAT'S A GREAT, GREAT, POINT.
THANKS KAREN.
THANKS MONICA, THIS IS JUST THE
BEGINNING, RIGHT?
WE'VE GOT A LOT OF WORK TO DO, A
LOT OF WORK AHEAD OF US AND
WE'RE HERE TO HELP.
SO MOVING RIGHT ALONG ON THE
AGENDA, NEXT UP IS THE
LEGISLATIVE REPORT WHICH WILL BE
BROUGHT TO US BY MK HOLOHAN.
MK?
>>HI, EVERYONE.
GOOD AFTERNOON.
THANK YOU FOR THE OPPORTUNITY TO
SPEAK WITH YOU.
I WANTED TO REMIND YOU ABOUT A
DETAILED LEGISLATE UPDATE IN
YOUR MEETING MATERIALS, I AM
HAPPY TO TALK WITH YOU OR YOUR
STAFF IF YOU HAVE SPECIFIC
QUESTIONS.
IN THE TIME WE HAVE TODAY, I
WOULD HAVE AN ABBREVIATED
COVERAGE HERE.
CAN I GET THE NEXT SLIDE,
PLEASE.
SO I WILL TALK ABOUT LEADERSHIP
CHANGES IN THE 118th CONGRESS,
I WILL TALK ON DEBT NOAKSES THAT
HAVE BEEN DONE, THE FY24
APPROPRIATIONS PROCESS AND WHAT
WE EXPECT WILL HAPPEN THERE AND
THEN WE WILL TOUCH ON OVERSIGHT
AND THAT WILL BE A BIG PART OF
THIS CONGRESS AND NIH WILL BE
PART OF A LOT OF THOSE
DISCUSSIONS.
NEXT SLIDE PLEASE.
SO THIS IS OUR NEW LEADERSHIP IN
CONGRESS, WE HAVE HERE, THE
HOUSE AND SENATE TAPPED--EACH
CHAMBER HAS A UNIQUE POSITION.
THE SPEAKER OF THE HOUSE IS
OBVIOUSLY ONLY JUST IN THE
HOUSE, THE SENATE HAS A
PRESIDENT PROTEMPORY WHICH IS
SENATOR PATTY MURRAY, IT IS
USUALLY THE MOST SENIOR SENATOR,
IN THIS CASE SHE IS 1 OF THE
MOST SENIOR SENATORS SO THIS
PERSON IS, THE VICE PRESIDENT IS
FIRST IN LINE FOR THE SUCCESSION
OF THE PRESIDENT, THEN THE
SPEAKER OF THE HOUSE, THEN THE
PRESIDENT PROTEMPORY, AND WE
HAVE NEW LEADER AND GENERATIONAL
CHANGES ON THE HOUSE DEMOCRAT
SIDE.
WE HAVE EXPERIENCED
LEGISLATORRINGS THROUGHOUT BOTH
PARTIES AND BOTH CHAMBERS HERE
SO WE ANTICIPATE THAT
THEY--THESE PEOPLE REALLY HAVE
BEEN SEASONED AND THEY HAVE BEEN
HAVING LEADERSHIP POSITIONS FOR
SOMETIME.
AS I THINK EVERYONE KNOWS
SPEAKER MCCARTHY BECAME SPEAKER
HAVE QUITE A SLOG, THERE ARE 15
VOTES FOR THEM TO GET THE VOTES
HE NEEDED TO BECOME SPEAKER AND
HE MADE A LOT OF CONCESSIONS IN
ORDER TO GET THOSE VOTES TO SOME
OF THE MORE CONSERVATIVE MEMBERS
OF HIS PARTY.
WE WILL FOCUS ON A COUPLE HERE.
ONE OF THEM WAS TO--HE PLEDGED
TO CUT SPENDING LEVELS TO TD
FY22 FUNDING LEVEL.
THAT'S TIED TO THE DEBT LIMIT.
THEN HE ALSO PLEDGED THAT THERE
WOULD BE NO BIG OMNIBUS SPENDING
BILLS.
IT'S SORT OF UNDERSTANDABLE,
THESE ARE LIKE 4000 PAGES, A LOT
OF MEMBERS ARE FRUSTRATED BY THE
AMOUNT OF TIME THAT THEY'RE
GIVEN TO REVIEW THESE DOCUMENTS.
THEY'RE ALWAYS SORT OF LAST
MINUTE, YOU KNOW THERE'S A C.
R., FUNDINGS' ABOUT TO RUN OUT,
BUT WE'RE GOING TO RETURN IT
THAT IN A LITTLE BIT.
NEXT SLIDE, PLEASE.
AND SOME OF THESE CONCESSIONS
WILL HAVE CONCRETE EFFECTS ON
THE APPROPRIATION PROCESS AND
THAT'S WHY I BRING THEM UP HERE.
SO THE DEBT SEALING.
WE HAVE SEEN DEBT SEALING SHOW
DOWNS BEFORE.
CONGRESS HAS PASSED 20 DEBT
LIMIT INCREASES SINCE 2001.
THERE HAVE BEEN OVER A HUNDRED
SINCE THE EARLY 1900S, THE ISSUE
HERE IS THAT THERE'S--THE DEBT
CEILING PRESENTS A LEVERAGING
OPPORTUNITY.
MOSTLY, YOU KNOW WHEN WE'VE SEEN
BUDGET DEALS, DEFICIT REDUCTION,
REDUCTION LEGISLATION, - IT IS
NONAPOPTOTIC THE A COINCIDENCE
THAT THEY TYPICALLY HAPPEN IN
PARALLEL TO A DEBT LIMIT VOTE.
THIS GRAPHIC I THOUGHT WAS
INTERESTING, IT SHOWS THE VOTES
FOR THE DEBT LIMIT CEILING, HOW
PARTIES VOTE WHEN THEIR PARTY IS
IN THE WHITE HOUSE AND YOU CAN
SEE THAT BOTH PARTIES WILL
SUPPORT THE LIMIT INCREASES IN A
HIGHER PROPORTION WHEN THEIR
PARTY IS IN THE WHITE HOUSE AT
THAT TIME BUT YOU KNOW THIS
BECOMES AN ISSUE OF
PRESIDENTING, IT BECOMES AN
ISSUE OF PARTY PRIORITIES.
THE MAJORITY PARTY AND THE
WHITE HOUSE ALWAYS WANTS A CLEAN
DEBT LIMIT INCREASE.
THEY DON'T WANT TO HAVE TO BE
MAKING DEALS ABOUT SPENDING
PRIORITIES AND POSSIBLY, YOU
KNOW SACRIFICES SOME TOOLS THEY
HAVE TO ADVANCE THEIR OWN AGENDA
AND PRIORITIES IN ORDER TO
PREVENT THE U.S. BREECHING THEIR
OBLIGATIONS ON DEBT THAT'S
ALREADY BEEN INCURRED BUT WE DO
SEE THESE PARALLEL WITH
DIFFERENT BUDGET FIGHTS.
WE HEARD THE WHITE HOUSE TALK
ABOUT WE'RE NOT NEGOTIATING ON
THE DEBT LIMIT BUT THEY'VE
ALREADY BEGAN DEBT NEGOTIATIONS
SO THERE'S NO WAY AROUND THIS.
WE DON'T KNOW HOW THIS IS GOING
TO PLAY OUT.
IT WOULD NOT BE SURPRISING IF WE
SAW SOME SORT OF 2 YEAR BUDGET
DEAL.
YOU KNOW THE X-DATE, THE DATE BY
WHICH THE TREASURY SAYS THE
EXTRAORDINARY MEASURES THAT
THEY'RE USING THAT THEY'RE
ALREADY USING TO TRY TO MAKE
SURE WE CAN MEET OUR DEBT
OBLIGATIONS, THOSE ARE
ANTICIPATED AND PROJECTED TO TO
BE DONE BY JUNE OR JULY.
SO THIS IS ALL GOING TO REALLY
HIT IN THE SUMMER AND SO THE
SPRING IS GOING TO BE A SPRINT
IN LOTS OF WAYS OF TRYING TO GET
TO SOME SORT OF NEGOTIATION
WHERE THEY CAN GET A DEBT LIMIT
VOTE AND GET SOME SORT OF
SPENDING DEAL THAT'S FEASIBLE.
NEXT SLIDE, PLEASE.
SO SOME OF THE PEOPLE WHO WILL
BE IN THE DRIVING SEATS FOR THIS
NEGOTIATION IN THE SPRING ARE
THE WOMEN YOU SEE HERE IN THIS
PICTURE, AND THIS IS REALLY KIND
OF A REMARKABLE TIME.
FOR THE FIRST TIME THE LEADERS
OF THE HOUSE AND SENATE PROARGZS
COMMITTEES, DEMCRATE AND
REPUBLICANS ARE ALL WOMEN AS IS
THE OMB DIRECTOR, I THINK MISS
YOUNG IS THE FIRST APRICK AN
AMERICAN WOMAN TO RUN OMB, SHE
IS ALSO A LONG TIME HOUSE
APPROPRIATION STAFFER SO SHE
KNOWS THIS PROCESS BACKWARDS AND
FORWARDS, THE 4 MEMBERS HERE ON
THE LEFT IN THE RED JACKET IS
SUSAN COLLINS OF MAINE, SHE WILL
BE THE RANKING MEMBER ON THE
APPROPRIATIONS COMMITTEE IN THE
SENATE.
SENATE PATTY MURRAY OVER NEXT TO
THE RIGHT, SENATOR FROM
WASHINGTON LONG TIME MEMBER OF
THE SENATE, SHE HAS BEEN THE TOP
RANKING DEMOCRAT ON THE HHS IN
THE SENATE, YOUNG IS IN THE
MIDDLE AND TO THE RIGHT IS KAY
GRANGER, A LONG TIME CHAIR OF
THE HOUSE, SHE IS THE FULL CHAIR
OF THE HOUSE APPROPRIATIONS
COMMITTEE, A JOB THAT ROSA HAD
UNTIL THE MIDTERMS AND THESE
HAVE ALL WORKS TOGETHER SINCE
THE 1990S SO THEY REALLY KNOW
HOW TO GET THINGS DONE AND
THERE'S AN OLD JOKE IN D. C. AND
PARTIES DEMOCRATS AND
APPROPRIATORS I DON'T KNOW WHERE
THIS CAME FROM BUT YOU HEAR IT
FROM TIME TO TIME.
THERE'S SOME RATIONAL TO THIS
BECAUSE APPROPRIATORS HAVE TO BE
PRAGMATIC, THEY HAVE TO GET A
BILL DONE EVERY YEAR AND THEY
HAVE TO COMPROMISE TO GET IT
DONE.
FOR OTHER BILLS INTRODUCED
AUTHORIZING BILLS.
THREE-7% OF THOSE BECOME LAW AND
NOT THAT MANY GO THROUGH THE
PROCESS OF COMMITTEE HEARINGINGS
AND MARK UMKCS BUT
AAPPROPRIATORS HAVE TO GET A
BILL DONE EVERY YEAR.
THEY HAVE TO GET IT THROUGH THE
SUBCOMMITTEE, COMMITTEE, FLOOR
VOTE, CONFERENCE IT AND THEN
SEND IT TO THE PRESIDENT'S DESK
AND IF THEY DON'T DO THAT, THE
GOVERNMENT SHUTS DOWN.
SO YOU KNOW THAT IS PROBABLY WHY
APPROPRIATORS ARE VIEWED A
LITTLE DEFINITELY.
THEY TEND TO BE VERY PRAGMATIC
AND SOMETIMES LESS PARTISAN BUT
EVEN FOR THIS TEAM, THE OVERALL
XRNGAL CLIMATE WE'RE SEEING
RIGHT NOW WILL BE AN ENORMOUS
CHALLENGE.
THERE WILL NEED TO BE
COMPROMISES AND YOU KNOW NO 1'S
GOING TO GET EVERYTHING THAT
THEY WANT AND THE FACT THAT
THERE'S A NEW HOUSE MAJORITY
WILL BE IMPORTANT HERE.
THAT THE HOUSE APPROPRIATIONS
COMMITTEE HAD THEIR FIRST
MEETING YESTERDAY AND CHAIR
GRANGER ACKNOWLEDGED THAT THE
ODDS WERE STACKED AGAINST THEM
BUT THEY ARE GOING TO DO THEIR
BEST.
NEXT SLIDE, PLEASE.
I WANT TO SHOW YOU THE NEW
MEMBERS OF THE HOUSE LABOR HHS
APPROPRIATES SUBCOMMITTEE.
WE HAVE NEW LEADERSHIP ON THE
REPUBLICAN SIDE.
TOM COLE FROM OKLAHOMA HAD BEEN
THE LONG TIME TOP REPUBLICAN ON
THIS SUBCOMMITTEE, REALLY GREAT
ADVOCATE FOR CANCER RESEARCH AND
HE WAS VERY WELL INFORMED ABOUT
NIH AND IN, CI, HE USED TO BRING
THE BIPARTISAN GROUP EVERY YEAR
TO COME VISIT ON CAMPUS AND HERE
FROM SEVERAL IC DIRECTORS AND
CONGRESSMAN DELORA RODRIGUEZ O
WHEN SHE WAS CHAIR HAS BEEN VERY
ENGAGED AND IS VERY WELL
ACQUAINTED WITH NIH AND OUR
PROGRAMS.
UNFORT FATALLY CHAIRMAN COLE WAS
NOT GIVEN A WAIVER TO MAINTAIN
THE SUBCOMMITTEE SO HE IS NOW
CHAIRING THE TRANSPORTATION
SUBCOMMITTEE.
HE'S ALSO THE VIETION CHAIR OF
THE FULL APPROPRIATIONS
COMMITTEE SO HE WILL STILL BE
INVOLVED IN SOME WAY, LETTING
THE REPUBLICANS FOR THE
SUBCOMMITTEE IS CONGRESSMAN
ROBERT ODERHOALT, HE'S RUN THE
APPROPRIATIONS SUBCOMMITTEE
AGRICULTURE AND OTHERS IN THE
PAST HE'S BEEN A LONG TIME
APPROPRIATOR AND CONGRESSWOMAN
DELAURO KNOWS HIM WELL AND
THEY'VE BEEN ON AG TOGETHER AND
WE THINK THIS COMMITTEE WILL
WORK WELL.
THERE A LOT OF EXPERTISE ON THE
COMMITTEE, MIKE SIMPSON FROM
IDAHO WHO HAS BEEN ON THE
COMMITTEE IN YEARS PAST IS
RETURNING TO THE COMMITTEE AND
STENY HOYER, HE WAS ON THE
PROARGZS COMMITTEE, HE IS GOING
TO BE JOINING THE DEMS ON THEIR
SUBCOMMITTEE.
SO THE NEW MEMBERS HERE ARE
NOTED IN BLUE.
AND WE DON'T KNOW SOME OF THESE
NEW MEMBERS SO WE WILL BECOME
ACQUAINTED WITH THEM THROUGHOUT
THE PROCESS, CAN I GET THE NEXT
SLIDE, PLEASE.
IN THE SENATE WE'RE GOING OUT ON
A LIMB HERE, WE KNOW SENATOR
MURRAY IS THE TOP--SHE'S THE
CHAIR OF THE FULL PROARGZS
COMMITTEE, PATRICK LAHEY WAS IN
THIS POSITION UNTIL HE RETIRED.
SUSAN COLLINS IS TAKING THE
MEMBER SLOT.
HE ALSO RETIRED IN THE LAST
117th CONGRESS AND SO, THIS IS
REPORTED, IT IS NOT OFFICIAL OR
CONFIRMED IN AN PROARGZS
COMMITTEE,A NOUNSMENT BUT OUR
UNDERSTANDING IS, AND WE FEEL
PRETTY CONFIDENT OF THIS, OF THE
SOURCES WE HEARD THAT SENATOR
TAMMY BALD WIN OF WISCONSIN WILL
BE THE CHAIR OF THE LABOR HHS
SUBCOMMITTEE AND SENATOR SHELLY
MOORE CAPITO, WILL BE THE
RANKING MEMBER.
BO BOTH OF THESE SENATORS ARE
VERY FAMILIAR WITH NIH AND NCI,
THEY BOTH VISITED SPECIFICALLY
VISITED NCI ON CAMPUS AND SO,
THAT--WE EVEN HAVE MORE OF WOMEN
IN CONGRESS WORKING AS
APPROPRIATORS FOR THE LABOR HHS
BILL.
NEXT SLIDE, PLEASE.
SO IT IS REALLY HARD TO MAKE
PREDICTIONS ABOUT HOW THINGS
WILL PLAY OUT AND THAT IS TRUE
IN ANY YEAR BUT THIS YEAR,
BECAUSE OF THE AGREEMENTS AND
THE STRONGLY STATED POSITION OF
THE HOUSE GOP THAT THEY WANT TO
RETURN TO FY22 FUNDING LEVELS.
IT IS EVEN HARDER THIS YEAR TO
TRY TO FIGURE OUT HOW THEY'RE
GOING TO GET TO SOME COMPROMISE
AND GET A GOVERNMENT FUNDING
BILL IN PREP FOR FY24.
WE'RE VERY USED TO CONTINUING
RESOLUTIONS BECAUSE THERE'S AN
AVERAGE OF 5 OR SO A YEAR, SOME
ARE VERY SHORT, SOME AS YOU CAN
SEE IN THIS CHART HERE IN 2007
AND IN 2011, AND 2013, THESE ARE
FISCAL YEARS WE HAD FULL YEAR
CONTINUING RESOLUTIONS.
IT'S INTERESTING TO NOTE THOUGH
THAT THE DEFENSE APPROPRIATIONS
BILL, THEY'RE INDIVIDUAL BILL
HAS NEVER BEEN PART OF A FULL
YEAR C. R.
THERE HAVE BEEN ADJUSTMENTS TO
THEIR BILL THAT WOULD ALLOW THEM
TO HAVE INCREASED FUNDING.
SO WE DON'T KNOW WHAT'S GOING TO
HAPPEN IN TERMS OF FULL YEAR C.
R. OR THERE'S ALL SORTS OF
OUTCOMES.
THE APPROPRIATORS COULD PASS THE
BILL THAT NEEDS THE OVERALL FY22
FUNDING LEVEL BUT THERE ARE
CERTAINLY GOING TO BE WINNERS
AND LOSERS IN THAT.
AGENCIES CAN'T REALLY ASSUME
THAT WHAT WE RECEIVED IN FY22 IS
WHERE WE'RE STARTING FOR THIS
PROCESS WITH FY24.
BECAUSE THE FY22 GOAL IS AN
OVERALL GOAL, THAT'S ACROSS ALL
12 SUBCOMMITTEES.
SO, IT IS NOT--IT'S SOMEWHAT
OBVIOUS THAT THEY ARE NOT GOING
TO BE AN ACROSS THE BOARD
REDUCTION.
DEFENSE IS GOING TO BE TREATED
DIFFERENTLY IF THERE WERE THAT
SORT OF CUT TO DEFENSE, IT WOULD
REALLY DIVIDE THE REPUBLICAN
CAUCUS, THERE WON'T BE BE THE
SORTS OF CUTS TO VETERANS
ACCOUNTS AND SOME OF THE
VETERANS PROGRAMS HAVE ADVANCED
PROARGZS ANYWAY SO THOSE ARE
REALLY ALREADY OUT THE DOOR.
WE REALLY JUST DON'T KNOW HOW
THIS WILL HAPPEN.
THERE COULD BE A BILL THAT HAS
STRATEGIC CUTS.
ONE THING THE APPROPRIATORS
MIGHT LOOK AT IS LOOK AT FUNDS
THAT BEEN APPROPRIATED BUT ARE
NOT SPENT AND THEY MAY RESCIND
THOSE FUNDS IN ORDER TO WRITE
THESE BILLS.
THAT WOULD BE THINGS LIKE
UNSPENT COVID FUNDS, POTENTIALLY
FUNDS THAT HAVE BEEN AUTHORIZED
FOR INSTRAY JECTORY STRUCTURE
PROGRAMS FOR SOME OF THE BIG
LEGISLATIVE PROGRAMS THAT
HAPPENED IN THE LAB AT CONGRESS.
WE DON'T KNOW HOW THIS IS GOING
TO PLAY OUT BUT THERE'S A COUPLE
WAYS THESE APPROPRIATORS AND
THESE VERY EXPERIENCED SKILLED
GROUP OF APPROPRIATORS COULD
FIGURE OUT HOW TO GET TO MARK UP
A BILL AT A LEVEL THAT WOULD BE
MEETING WHATEVER BUDGET DEAL
THEY END UP COMING UP WITH TO
GET A DEBT INCREASE BUT ALSO
PRESERVING ACCOUNTS THAT ARE
VERY POPULAR THAT HAVE A LOT OF
MEMBER SUPPORT AND WE CERTAINLY
HOPE THAT CANCER RESEARCH WOULD
BE FALLING INTO THE THAT
CATEGORY.
AND THEN THERE'S ALWAYS, NO 1
KNOWS IF WE'RE GOING TO HAVE,
THIS WILL BE COMPLETED BY THE
TIME THE FISCAL YEAR STARTS SO
THERE SEEMS TO BE QUITE A BIT OF
PESSIMISM ABOUT THE LIKELIHOOD
OF A SHUT DOWN AND A SHUT DOWN,
SOMETIMES THAT'S A VEHICLE FOR A
CATALYST TO GET THINGS MOVING,
THERE ARE SHORT SHUT DOWNS WE
HAD SHUT DOWNS THAT LASTED IN
LESS THAN A DAY IN THE PAST
RECENT YEARS BUT WE REALLY DON'T
KNOW HOW THIS IS GOING TO PLAY
OUT.
ONCE THERE'S A SHUT DOWN, THERE
NEEDS TO BE A SOLUTION SOLUTION
TO REOPEN SO AT THE END OF THE
DAY THERE NEEDS TO BE A DEAL.
WE ARE HOPEFUL IT WON'T COME TO
THAT BUT WE'RE GOING TO BE
WATCHING AS THE APPROPRIATORS
START MACKING UP, WHEN THEY COME
UP WITH ALLOCATIONS FOR EACH OF
THE SUBCOMMITTEES THEN WE WILL
GET A SENSE OF WHERE THEY'RE
TRYING TO PROTECT THE CURRENT
FUNDING LEVELS INCREASES FOR
SPECIFIC ACCOUNTS AND PROGRAMS
AND WHICH 1S ARE TARGETED FOR
MORE SEVERE REDUCTIONS AND AT
LEAST A PLAN THAT WILL BE PUT
FORWARD.
NEXT SLIDE, PLEASE.
SO BEFORE WE TALK ANYMORE ABOUT
THAT, I JUST WANTED TO REMIND
EVERYONE OF WHERE WE ENDED UP
FOR FY23, HOW THAT COMPARED TO
FY22 APPROPRIATION AND THEN AS
DR. BERGTONOLLI, STATED, THE
RELEASE WILL BE ON MARCH 9th.
IT'S LATER THAN NORMAL, USUALLY
IT'S THE FIRST MONDAY IN
FEBRUARY BUT THAT WILL BE THE
OFFICIAL START OF THE
APPROPRIATIONS PROCESS WHERE THE
PRESIDENT PUTS FORTH HIS REQUEST
FOR FY24 FUNDING FOR ALL
GOVERNMENT AGENCIES.
NEXT SLIDE, PLEASE.
SO 1 OF THE THINGS I THINK IS
WORTH NOTING WHEN WE TALK ABOUT
THE CONCESSIONS THAT SPEAKER
MCCARTHY MADE TO GET THE VOTES
HE NEEDED, WAS THAT HE--HE
AGREED TO NO MORE BIG OMNIBUS
SPENDING BILLINGS.
AND UNFORTUNATELY, YOU KNOW, THE
IDEA OF DOING 12 INDIVIDUAL
SPENDING BILLS AND HAVE THEM
ENACTED INTO LAW INDIVIDUALLY,
WHICH USED TO BE STABBED ARD,
THE LAST TIME WAS 2002, THERE
WAS A STRETCH OF MID80S TO 90S
WHERE IT HAPPENED FOR EACH BILL,
EACH 1 WAS A SEPARATE LAW AND
ENACTED AS A SEPARATE LAW BUT
MANY TIMES PACKAGES WHERE
THERE'S A COUPLE BUNDLED
TOGETHER, THOSE THAT HAVE THE
MOST SUPPORT AND LEAST
CONTROVERSIAL WHICH WILL NEVER
INCLUDE THE HHS BILL
UNFORTUNATELY, BUT THAT HAS
BECOME REALLY COMMON AND IT WAS
HAPPENING IN THE 1970S AND IT'S
BEEN HAPPENING EVER SINCE AND
IT'S HARD TO IMAGINE THAT IT'S
POSSIBLE FOR 12 SPENDING BILLS
TO GET DONE AND THERE MAY NOT
EVEN BE 12 BILLS PASSED OUT OF
THE HOUSE AND SENATE
APPROPRIATIONS COMMITTEE AND
ACHIEVING VOTES ON THE FLOOR.
THE BOTTOM LINE, I THINK AND MY
MAIN MESSAGE TO ALL OF THE--OUR
LEADERSHIP AND THE RESEARCH
COMMUNITY IS WE SHOULD EXPECT TO
SEE AS THE PROCESS PLAYS OUT
SOME DISAPPOINTING AND PERHAPS
ALARMING NUMBERS WHEN THE
SUBCOMMITTEES CAN ONLY WORK WITH
THE ALLOCATIONS THEY'RE GIVEN.
MY MESSAGE IS NOT TO PANIC
BECAUSE THERE IS A LONG ROAD TO
GO BEFORE WE HAVE FINAL FUNDING,
BEFORE DECISIONS ARE COMPLETED
AND THINGS MAY LOOK WORSE BEFORE
THEY LOOK BETTER, I THINK WE'RE
ALL WELL AWARE OF THE--IN
ADDITION TO THE STRONG
BIPARTISAN SUPPORT FOR CANCER
RESEARCH, YOU KNOW THE PRESIDENT
HAS BEEN VERY CLEAR ON HIS
COMMITMENT TO CANCER RESEARCH
AND SOME OF THE THINGS THAT BEEN
DISCUSSED IN THIS MEETING
ALREADY, THAT IS SOMETHING THAT
HE IS REITERATED SO THIS WILL BE
A PRIORITY AND IT'S A SHARED
PRIORITY.
AND THERE MAY BE DIFFERENT VIEW
POINTS AS TO WHAT LEVELS ARE
NEEDED AND PROGRAMS SHOULD BE
PROMOTED BUT IT IS A SHARED
PRIORITY AND WE ARE VERY HOPEFUL
THAT THAT WILL CONTINUE TO BE
SOMETHING WHERE, YOU KNOW IN THE
END WE WILL END UP IN A GOOD
PLACE FOR FY24.
AND A GOOD PLACE MAY BE STAYING
WHOLE, IT MAY BE SLIGHT
INCREASES, I DON'T THINK THIS IS
A YEAR WHERE WE CAN EXPECT
DRAMATIC INCREASES, BUT WE WILL
HAVE TO SEE WHAT HAPPENS, WE
DON'T KNOW WHAT'S IN THE
PRESIDENT'S BUDGET REQUEST AND
WE DON'T KNOW HOW HE HAS
PRIORITIZED HIS REQUESTS.
OVERSIGHT WILL BE A REALLY MAJOR
PART OF THIS ENTIRE CONGRESS AND
WE'VE ALREADY SEEN IT START,
THESE ARE JUST SOME TITLES OF
HEARINGS THAT HAVE BEEN HELD IN
THE PAST WEEK.
THERE WAS A COVID HEARING IN THE
HOUSE OVERSIGHT COMMITTEE ABOUT
SOME OF THE PAYCHECK PROTECTION
ACT FUNDING AND WHERE THINGS
WENT TOO.
THERE'S BEEN REAL CONCERNS ABOUT
OVERSIGHT AND FRAUDULENT
OBTAINING OF THESE LOANS.
THERE WAS A HEARING YESTERDAY IN
THE ENERGY AND HOUSING COMMITTEE
WHICH IS THE COMMITTEE UNDER
WHICH NIH FALLS, THIS INCLUDED
THE CDC DIRECTOR, NIH, AND
DR. TABAK WHO IS IN THE ACTING
ROLE FOR THE NIH IS TITLE IS NOW
PERFORMING THE OFFICIAL DUTIES
OF THE NIH DIRECTOR BECAUSE HE
WAS IN AN ACTING ROLE FOR LONGER
THAN THE TIME WE'RE ALLOWED TO
BE IN THAT STATUS.
BUT THIS HEARING WAS A LOT ABOUT
THE DIFFERENT AGENCIES RESPONSES
TO COVID AND THE DIFFERENT ROLES
THAT EACH AGENCY HAD, THERE'S A
LOT DISAGREEMENT ABOUT GUIDANCE
AND OPINIONS ABOUT DECISIONS
THAT WERE MADE ABOUT THE
DIFFERENT AGENCIES AND SO IT WAS
A FAIRLY DIFFICULT HEARING, I
THINK IT'S WHAT WAS EXPECTED BUT
WE'RE GOING TO SEE MANY MORE OF
THESE HEARINGS DURING THE COURSE
OF THIS CONGRESS AND THE
PROARGZS ARE IN SOME WAYS ALSO
AN OPPORTUNITY FOR OVERSIGHT AND
WITH A LOT OF NEW MEMBERS I
THINK WE WILL SEE A LOT OF
DIFFERENT SORTS OF QUESTIONS
THAN WE HAVE BEEN SEEING IN THE
PAST 6-7 YEARS EMPLOY SO I
THINK, STAY TUNED AND DON'T
PANIC ABOUT LAWEDDER DALE YOU
SEE, THE SPRING IS GOING TO
BE--IT'S A FRENETIC PACE FOR THE
APPROPRIATORS, TELL BE DIFFICULT
AND THE DEBT LIMIT DRIVING THE
URGENCY IS GOING TO AFFECT THE
PACE OF THINGINGS AND TRY TO
JUST RESERVE JUDGMENT.
SEPTEMBER IS A LONG WAY AWAY.
THANK YOU.
I WILL BE HAPPY TO TAKE
QUESTIONS HERE IF DR. CARPTEN
SAYS WE HAVE TIME AND IF NOT,
GET IN TOUCH WITH ME AT YOUR
CONVENIENCE, I WILL BE HAPPY TO
TALK WITH YOU.
>>THAT'S GREAT.
THANK YOU SO MUCH M. K.
IF THERE AREN'T ANY BURNING
QUESTIONS, WE COULD ENTERTAIN 1,
BUT I THINK WE DO NEED TO
ADVANCE THE AGENDA.
SO THANKS M. K. AND AGAIN, IF
THERE ARE ANY QUESTIONS, WE CAN
PROVIDE THEM TO PAULET AND SHE
CAN INTERFACE WITH YOU TO GET
RESPONSES FOR THOSE.
THANK YOU SO MUCH.
NEXT UP ON OUR AGENDA WILL BE
THE ANNUAL DELEGATIONS OF
AUTHORITY AND THEY WILL BE
BROUGHT TO US BY DR. GRAY.
>>OKAY, SO, I WILL BE THE
BORING 1 TODAY BUT AS YOU KNOW,
I ROLL THROUGH THIS QUICKLY TO
GET US BACK ON TIME TARGET.
ANNUALLY AT THE FIRST NCAB
MEETING THE BOARD MUST APPROVE
SPECIFIC DELEGATIONS OF
AUTHORITIES SO THAT THE DIRECTOR
AND NCI STAFF CAN FUNCTION
WITHOUT HAVING TO COME YOU AS
NCAB MEMBERS FOR CERTAIN
ACTIONS.
SPECIFICALLY DELEGATION A STATES
THAT THE NCAB DELEGATES TO THE
DIRECTOR OF THE NATIONAL CANCER
INSTITUTE PERMISSION TO OBTAIN
AS STATED IN SECTION 413 B, 5 OF
THE PUBLIC SERVICE ACT, AND IN
ACCORDANCE WITH SECTION 3, 109
OF TITLE 5, UNITED STATES CODE,
THE OPPORTUNITY TO REQUEST THE
SERVICES OF NOT MORE THAN 151
SPECIAL EXPERTS OR CONSULTANTS
WHO HAVE SCIENTIFIC OR
PROFESSIONAL QUALIFICATIONS TO
ASSESS AND ACCOMPLISHING
SOLUTION
ACCOMPLISHING--MISSION OF THE
INSTITUTE.
DELEGATION B, THE NCAB DELEGATES
TO THE DIRECTOR NCI PERMISSION
TO EXERCISE AUTHORITY AS STATED
IN SECTION 413 B-7 OF THE PUBLIC
HEALTH SERVICE ACT, THE
OPPORTUNITY TO ESTABLISH 1 OR
MORE ADVISORY COMMITTEES
COMPOSED OF PRIVATE CITIZEN AND
OFFICIALS OF FEDERAL, STATE AND
LOCAL GOVERNMENTS TO ADVISE HIM
OR HER WITH RESPECT TO HIS OR
HER FUNCTIONS.
NEXT IS THE STATEMENT OF
UNDERSTANDING OF WHAT THE NCI
STAFF WILL OPERATE IN PRINCIPLES
IN MAKING EXTRAMURAL AWARDS
WITHIN ACCORDANCE WITH
MANAGEMENT AND REVIEW PROCEDURES
SET FORTH IN THE NIH MANUEL
ISSUANCE 4513.
NCAB CONCURRENT WITH
RECOMMENDITIONAS OF INITIAL
RECRUITMENTS WILL BE REQUIRED
FOR ALL GRANTS, THAT IS EXCEPT
FOR TRAINING GRANTS, FELLING
OSHIPS AND OTHER NONRESEARCH
GRANT APPLICATIONS.
THESE GRANTS MAY BE AWARD TD BY
NCI WITHOUT PRESENTATION TO THE
NCAB THAT IS WITH EXCEPTION OF
THE [INDISCERNIBLE] NATIONAL
RESEARCH SERVICE AWARDS.
APPLICATIONS MRI KAIGDZS OVER
THE 20th PERCENTILE WILL NOT
HAVE SUMMARY STATEMENTS
PRESENTED TO THE NCAB UNLESS THE
INTUITY IS CONSIDERING THE AWARD
OF SUCH AN APPLICATION OR FOR
SPECIAL CONSIDERATION BY AN
APPOINTED NUMBER OF THE BOARD.
APPLICATIONS ASSIGNED BOTH
SCORES THAT ARE NOT PERCENTILE,
THE CUT OFF WILL BE AN IMPACT
SCORE OF 45 FOR ALL MECHANISMS
EXCEPT R41S, 42S, 43s AND
44s, FOR THE LATTER AWARDS ALL
SCORED APPLICATIONS WILL BE
INCLUDED IN THE [INDISCERNIBLE].
EXPEDITED CONCURRENCE WILL BE
USED FOR RO-1 AND R21
APPLICATIONS, EXCLUDING THOSE
FROM FOREIGN ORGANIZATIONS.
THOSE APPLICATIONS PERCENTILE OR
GROWTH SCORES MUST FALL WITHIN
THE NCI PAY LINES AND THAT HAVE
NO CONCERNS NOTED THAT WOULD
REPRESENT AN ADMINISTRATIVE BAR
TO AWARD.
BARS TO AWARD WOULD INCLUDE HEAL
SUBJEBS, ANIMAL WELFARE,
BIOHAZARDS OR INCLUSION OF
WOMEN, CHILDREN, AND APPROPRIATE
MINORITY DISTRIBUTION.
EXPEDITED CONCURRENCE WILL BE
DELEGATED BY THE CHAIR TO
SPECIFICALLY DESIGNATED MEMBERS
OF THE BOARD ACTIVE ON BEHALF OF
THE BOARD AS A WHOLE.
THE REVIEWERS WILL CONSIST OF
THE CHAIR, OF THE SUBCOMMITTEE
ON SPECIAL ACTIONS AND 3 ARK
DITIONAL NCAB MEMBERS AS
APPOINTED BY THE CHAIR OF THE
NCAB.
IN PACES OF EMERGING NEED AS
DETERMINED BY THE DIRECTOR NCI,
WITH THEIR CONCURRENCE OF THE
NCAB CHAIR, EXPEDITED
CONCURRENCE MAY BE UTILIZED FOR
SINGLE CASE DEVIATIONS.
EXPEDITED [INDISCERNIBLE] OF
ENOUGH FOLKS FOR FINAL ACTION
WILL BE PRESENTED TO THE FULL
NCAB AT ITS REGULAR MEETING.
IN TERMS OF ADMINISTRATIVE
ADJUSTMENTS, THE NCAB DELEGATES
TO THE DIRECTOR NCI PERMISSION
TO OUR STAFF TO NEGOTIATE
APPROPRIATE ADJUSTMENTS IN
DOLLARS OR OTHER TERMS AND
CONDITIONS OF GRANT AND
COOPERATIVE AGREEMENT AWARDS
RECOMMENDED BY THE BOARD.
IN DOING SO, THIS ALLOWS THE
INSTITUTE TO MAINTAIN A SMOOTH
AND EFFECTIVE OPERATION OF THE
ADMINISTRATION OF RANKS BY
INSTITUTE.
STAFF WILL NEGOTIATE APPROPRIATE
ADJUSTMENTS AND WHEN APPLICABLE
WILL MAKE ADJUSTMENTS TO
RECONCILE INCONSISTENCIES
BETWEEN RECOMMENDED BUDGET AND
RECOMMENDED AIMS AND ACTIVITIES.
ADMINISTRATIVE REQUESTS FOR
INCREASES IN DIRECT COSTS WHICH
ARE THE RESULT OF MARKED
EXPANSION OR SIGNIFICANT CHANGE
AND SCIENTIFIC CONTENT OF A
PROGRAM, AFTER FORMAL PEER
REVIEW WILL BE REFERRED TO THE
BOARD BY ADVICE THROUGH
RECOMMENDATION.
IF THERE'S AN ISSUE THAT IS
TERMS OF SCOPE AND URGENCY, THE
DIRECTOR NCI WILL CONSULT WITH
THE NCAB CHAIR PRIOR TO A FINAL
DETERMINE NATION.
THE NCAB CHAIR WILL ACT ON
BEHALF OF THE BOARD AS A WHOLE.
IN TERMS OF ACTIONS NOT
[INDISCERNIBLE] REVIEW OR
ADVICE, THOSE INCLUDE ACTIONS
SUCH AS CHANGE OF INSTITUTION,
CHANGE OF PRINCIPLE
INVESTIGATOR, PHASE OUT OR
INTERIM SUPPORT OR ADDITIONAL
SUPPORT, THE OPPORTUNITY OF
INCREASED COSTS MAINTAINED AT A
LEVEL OR RESEARCH PREVIOUSLY
RECOMMENDED OR TO ACCOMMODATE
ACTIVITIES JUDGED BY STAFF TO BE
WITHIN THE SCOPE OF THE THE PEER
REVIEW RESEARCH.
THESE ACTIONS WILL NOT BE
REPORTED TO THE BOARD.
IN ADDITION STAFF MAY RESTORE
REQUESTED TIME AND SUPPORT WHICH
WERE DELETED BY THE INITIAL
REVIEW GROUP WHICH THE PRINCIPLE
INVESTIGATOR HAS PROVIDED
JUSTIFICATION IN AN APPEAL
LETTER, THE RESTORATION IS IN
THE BEST INTEREST OF THE NCI,
AND THE PROJECT IS OF HIGH NCI
PROGRAMMATIC RELEVANCE.
DIRECTOR OF NCI AFTER
CONSULTATION WITH THE NCAB CHAIR
MAY MAKE EXCEPTIONS TO THESE
GUIDELINES.
FINALLY, THERE'S A SPECIAL
CANCER REVIEW WHICH IS SCR AND
ALL OF YOU ARE AWARE OF IT, A
PRINCIPAL INVESTIGATORS WITH
2 MILLION TOTAL COSTS OR MORE IN
RPG AWARDS.
IN AN EFFORT TO CONDITION
RESPONSIBLE STEWARDSHIP OF
PUBLIC FUNDS AND TO SUPPORT
MERITORIOUS AND INNOVATIVE
RESEARCH, NIH HAS INSTITUTED
POLICIES OF SPECIAL CANCER
REVIEW OF THE APPLICATIONS FROM
WELL FUNDED INVESTIGATORS.
PENDING GRANTS, GOING TO THE
BOARD FOR PRINCIPAL
INVESTIGATORS, THEY HAVE MORE
THAN 2 MILLION OR MORE IN DIRECT
COSTS FROM ACTIVE NCI RESEARCH
PROJECT GRANTS, MUST BE GIVEN AN
ADDITIONAL CONSIDERATION.
IT IS IMPORTANT TO RECOGNIZE
THAT THIS IS A THRESHOLD ONLY.
INVESTIGATORS WHO HAVE MORE
RESEARCH SUPPORT MAY STILL
RECEIVE ADDITIONAL AWARDS AS
WARRANTED.
ARE THERE QUESTIONS OR IS
FURTHER CLARIFICATION NEEDED?
IF NOT THEN JOHN WILL CALL FOR A
VOTE FOR APPROVAL, DISAPPROVAL
OR ABSTENTION, OR ABSTENTION OF
THE DELEGATIONS OF AUTHORITY.
JOHN?
DID I GO FAST ENOUGH?
>>[LAUGHTER]
THANK YOU, P A ULETTE.
ARE THERE ANY QUESTIONS FOR
PAULET?
IF NOT, WE NEED TO CALL A MOTION
TO APPROVE.
IS THERE A MOTION?
>>MOTION.
>>SECOND?
>>SECOND.
>>WE CAN PROBABLY MOVE MOVED
AND SECOND.
DISCUSSION?
SO WE CAN NOW PROCEED TO VOTE TO
ACCEPT.
AND ARE THERE ANY NAYS?
ANY ABSTENTIONS?
NO, SO P A ULETTE, IT'S
UNANIMOUS.
>>IT'S UNANIMOUS.
>>OKAY, GREAT.
THANK YOU ALL SO MUCH, THANK YOU
P A ULETTE, OUR FINAL
PRESENTATION WILL BE BROUGHT TO
TO US BY JIM DOROSHOW, HE IS
DEPUTY CLINICAL DIRECTOR FOR
RESEARCH AND CLINICAL CANCER
TREATMENT AND DIAGNOSIS AND AT
THE IN, CI AND HE WILL PRESENT
WHICH IS FASNAILTING ADAPTING
NCIA CLINICAL TRIALS SYSTEM TO A
CHANGED CLINICAL RESEARCH
ENVIRONMENT.
JIM?
>>THANKS JOHN AND THANKS TO
EVERYONE FOR THE CHANCE TO
REVIEW WITH YOU THE IMPACT OF
THE EVENTS OF THE LAST 3 YEARS
ON THE NCIA CLINICAL TRIALS
SYSTEMS.
NEXT SLIDE.
SO MY TALK WILL FIRST PROVIDE
DATA ON THE INITIAL AND ONGOING
EFFECTS OF THE PANDEMIC
ENVIRONMENT ON CLINICAL TRIALS.
TALK A LITTLE BIT ABOUT SOME OF
THE MAJOR FEATURES OF OUR
STRATEGIC VISION, FOR CLINICAL
TRIALS THAT WERE DEVELOPED
DURING THE PANDEMIC AND THEN
ACTIVITIES THAT WE ARE
UNDERTAKING TO TRY TO AMELIORATE
THE CLINICAL RESEARCH WORKFORCE
PROBLEMS THAT ALL OF YOU ARE
FAMILIAR WITH.
NEXT SLIDE.
SO LET ME JUST REVIEW THINGS
THAT I THINK ARE FAMILIAR TO
EVERYONE.
WE KNOW ABOUT THE ROAD BLOCKS
THAT BEGAN JUST ALMOST EXACTLY 3
YEARS AGO TO CLINICAL TRIAL
ACCRUAL.
AND WE WERE FACED WITH A
SITUATION IN WHICH, IN-PERSON
ACTIVITIES, GETTING INKORMED
CONSENTS RECEIVING
INVESTIGATIONAL DRUGS AT
HOSPITALS, ASSESS THES, FOR
PATIENT SAFETY AND ADHERENCE
WERE ALL ADVERSELY IMPACTED
BECAUSE OF THE DIFFICULTIES OF
PROVIDING SAFE WAY FOR PATIENTS
TO RECEIVE THOSE KINDS OF
TREATMENTS.
WE ARE ALL FAMILIAR WITH THE
PROBLEMS NECESSARY THAT WERE
NECESSITATED BECAUSE OUR
CLINICAL PROTOCOLS REQUIRED
PATIENT IT IS TO COME FOR
IMAGING ACTIVITIES, FOR
LABORATORY AND DIAGNOSTIC TESTS
TO CENTRAL FACILITIES.
I THINK, MANY, NOT ALL OF YOU
PERHAPS UNDERSTAND HOW ALL OF
OUR TRIALS COLLECTED ENORMOUS
AMOUNTS EVER DATA ON HIGH GRADE
AND LOW GRADE ADVERSE EVENTS OF
PERHAPS MINIMAL RELEVANCE TO THE
END POINTS OF THE STUDIES BUT
ALSO REQUIRED PATIENTS TO COME
TO CENTRAL FACILITIES AND ALL OF
THAT WAS ADVERSELY AFFECTED BY
THE FACT THAT THERE WERE GREAT
DIFFICULTIES IN TERMS OF MAKING
AND HAVING THE PERSONNEL AND THE
FACILITIES AVAILABLE FOR
PATIENTS TO COME TO BECAUSE OF
THE COVID PANDEMIC AND THE
REPROGRAMMING OF CLINICAL
RESEARCH NURSES FOR CARE.
BUT WHAT I WOULD LIKE TO
EMPHASIZE IS THAT ALL OF THOSE
THINGS HAVE--WE'VE ADAPTED TO
MANY, IF NOT ALL OF THOSE
ISSUES, BUT THERE ARE CONTINUING
MAJOR ONGOING ISSUES.
AS ANYONE WHO RUNS A CLINICAL
TRIALS OFFICE OR EVERY CLINICAL
INVESTIGATOR ACROSS OUR CANCER
CENTERS UNDERSTANDING THERE
CONTINUE TO BE CRITICAL
SHORTAGES OF RESEARCH NURSES,
CRAs, REGULATORY STAFF AS WELL
AS ESSENTIAL HEALTH WORKERS,
PATHOLOGY AND RADIOLOGY
FACILITIES.
WE HAVE--WE LACK THE APPROPRIATE
STAFFING IN OUR IRBs AND IN
OUR LEGAL AND CONTRACTING
OFFICES AND ALL OF THOSE THINGS
HAVE DECREASED THE AVAILABILITY
OF CLINICAL TRIALS, HAVE HAD AN
ADVERSE EFFECT ON A CLINICAL
TRIAL ACCRUAL AND I WANT TO
EMPHASIZE HAS LED TO SUBSTANTIVE
DELAYS AND RESULT IN REPORTING
THAT ALSO HAVE LONG-TERM
NEGATIVE IMPACTS ON OUR CLINICAL
TRIAL SYSTEM.
NEXT SLIDE.
HOW DO WE RESPOND?
SO FIRST, HATS OFF TO ALL OF YOU
AND ALL OF YOUR INSTITUTIONS AS
WELL TO MY COLLEAGUES DR. MOONY
AND DR. STEPHENS FOR VERY RAPID
LOAMACYY AFTER THE ONSET OF THE
PANDEMIC MAKING MAJOR CHANGES TO
OUR SYSTEMS, WE MADE THE USES TO
ELECTRONIC CONSEBTING, WE
PROVIDED ORAL MEDS TO ALL
PATIENTS.
WE ISSUED ELECTRONIC RATHER THAN
IN-PERSON STUDY AUGHTITS.
WE FACILITATED TELEMEDICINE FOR
VISITS.
WE TOOK A POSITIVE VIEW OF HOW
TO LIMIT THE IMPACT OF MINOR
STUDY DEVIATIONS ON THE OVERALL
EVALUATION OF CLINICAL TRIAL
CONDUCT.
WE IMPLEMENTED VERY IMPORTANTLY
DECENTRALIZED TESTING REQUIRED
LAB AND IMAGING STUDIES AND
PERHAPS AS IMPORTANT AS ANY OF
THESE THINGS, DURING THE
PANDEMIC ITSELF, WE QUEPED A NEW
-DEVELOPED A NEW STRATEGIC
PLAN SOME OF WHICH WE HAVE NOW
IMPLEMENTED AND I WILL SHARE
WITH YOU.
NEXT SLIDE.
I WOULD LIKE TO SPEND THE NEXT
COUPLE MINUTES GOING OVER DATA
AND THIS IS UP TO DATE DATA
BEGINNING WITH JANUARY 2020 AND
CURRENT THROUGH DECEMBER OF
2022.
AND WHAT IT SHOWS IS THE ACCRUAL
TO EVERYTHING BUT OUR INDUSTRIAL
TRIALS AT THE NCI'S CANCER
CENTERS, ALL THE CANCER CENTERS
THAT DO CLINICAL TRIALS AND SO
ALL OF YOU ARE VERY FAMILIAR
WITH WHAT I CALL THE GRAND
CANYON EFFECT IN MARCH, APRIL
APRIL, MAY, JUNE OF 2020 WHERE
EVERY TYPE OF CLINICAL TRIAL WE
WERE CONDUCTING CHIBTED A MOIJOR
REDUCTION IN ACCRUAL.
BUT WHAT IS PERHAPS NOT SO WELL
KNOWN IS THAT AS CAN YOU SEE IN
GRAY, IT WAS A TREMENDOUS AND
WONDERFUL REBOUND AND ACCRUAL TO
OUR NCTN TRIALS THAT HAS
CONTINUED THROUGHOUT THE LAST 2
AND HALF 3 YEARS BUT I DON'T
THINK IT IS AS WELL APPRECIATED
THAT IF YOU LOOK IN BLUE OR IN
ORANGE, IF YOU LOOK AT ACCRUAL
TO INVESTIGATOR INITIATED TRIALS
OR EXTERNAL PERPERRY VIEW
TRIALS, SORE BY RO-1S OR R21S,
THOSE HAVE IN FACT NEVER
RECOVERED OVER 3 YEARS AND STILL
ARE AT ABOUT A 20-25% DECREASE
IN OVERALL CLINICAL TRIAL
ACCRUAL FOR THIS ENTIRE LAST 3
YEARS.
THE NEXT SLIDE WILL SHOW YOU
EVEN MORE DETAIL ABOUT EXACTLY
WHERE THE ISSUE IS.
SO CAN YOU SEE 2019 WITH ACCRUAL
IN THE RANGE OF ABOUT 50,000
PATIENTS A YEAR TO TREATMENT
TRIALS NOW AT NCI DESIGNATED
CANCER CENTERS, BUT WHAT I WOULD
LIKE TO POINT OUT IS THAT NOT
WHAT YOU ALL KNOW THERE WAS THIS
ENORMOUS DECREASE IN ACCRUAL IN
2020.
BUT LAWEDDER DALE'S HAPPENED IN
2021 AND 2022?
AND I THINK THAT THE FIRST THING
THAT'S PRETTY CLEAR IS THAT IF
YOU LOOK AT THE BOTTOM, IN BLUE,
HAPPILY OUR ACCRUAL TO THE NCTN
TRIALS HAS REMAINED STUDY AND
THAT'S A GREAT TRIBUTE TO THE
MEMBERS OF ALL OF OUR CLINICAL
TRIAL GROUPS.
WHAT YOU CAN TELL IN THE ACCRUAL
IN 2020 THAT HAS REBOUNDED AS
WELL.
BUT WHAT HAS NOT HAPPENED AS I
POINTED OUT IN THE MONTH TO
MONTH REVIEW IS THAT HERE YOU
CAN ACTUALLY SEE THE NUMBERS IN
LIGHT BLUE, KIND OF A TEAL
COLOR, THERE'S BEEN A 4-5000
PATIENT DECKRAMENT AT CANCER
CENTERS TO ACCRUAL INVESTIGATOR
INITIATED TRIALS.
THESE ARE THE TRIALS THAT ALL OF
OUR INVESTIGATORS RELY UPON TO
BRING IN NEW IDEAS AND GET
TENURE AND THIS HAS NOT
REBOUNDED.
AND THE SAME IS TRUE FOR
EXTERNAL PEER REVIEW TRIALS,
TRIALS FUNDED BY GRANTS.
THERE'S ABOUT A 20-30% DECREASE
THAT HAS NOT REBOUNDED IF YOU
TAKE UP TO THE FULL CALENT ARD
2022, THIS IS PERHAPS A MAJOR,
MAJOR IMPACT ON WHAT'S AVAILABLE
TO OUR PATIENTS.
NEXT SLIDE.
WE BASICALLY THOUGHT AND HEARD
FROM SO MANY PEOPLE THAT A LOT
OF THIS WAS DUE TO WORKFORCE
ISSUES THAT WE CONDUCTED A
SURVEY OF THE NCI DESIGNATED
CANCER CENTERS TO FIND OUT
REALLY WHAT WERE SOME OF THE
DETAILS ABOUT THE WORKFORCE
ISSUES THAT AT LEAST IN PART,
PERHAPS IN MAJOR PART WERE
RELATED TO THE DECK RAMENT AND
FILE ACCRUAL.
AND I THINK IT'S A TESTAMENT
THAT WE HAVE A HUNDRED PERCENT
RESPONSE RATE FOR ALL OF THE
CANCER CENTERS TO THESE
QUESTIONS.
NEXT SLIDE.
SO AGAIN, PROBABLY NOT A
SURPRISE TO ANYBODY WHO'S
INVOLVED IN THIS ON THE
DAY-TO-DAY BUT IF YOU FOCUS ON
WHAT IS IN DARK BLUE AND IN
ORANGE, WHAT YOU SEE VERY
CLEARLY IS THAT THE MAJOR ISSUES
THAT AFFECTED CLINICAL TRIAL
CAPACITY, ARE THE LACK OF STAFF.
SO THIS AFFECTED NOT ONLY THE
NUMBER OF TRIALS THAT COULD BE
OPENED, BUT ALSO IF YOU SEE ON
THE FAR RIGHT OF THE SLIDE, AND
LIMIT THE ABILITY OF OUR
RESEARCH STAFF TO ACCRUE
PATIENTS.
ACTUALLY MANY TRIALS WERE PUT ON
HOLD.
SO THE ISSUE IS NOT SO MUCH,
WHERE PATIENTS NOT AVAILABLE FOR
TRIAL BUT WE SIMPLY DIDN'T HAVE
THE WORKFORCE TO ANNUL THOSE
PATIENTS OR STUDIES AND THERE
WERE MANY OTHER ISSUES IN
HEALTHCARE FACILITIES THAT
ADVERSELY EFFECTED OUR ABILITY
TO CONDUCT OUR CLINICAL
INVESTIGATIONS.
NEXT SLIDE.
IF YOU LOOK AT REALLY WHY WAS
THERE THIS STAFF ATTRITION?
WELL, AGAIN, PROBABLY NOT A
SURPRISE TO ANYBODY WHO'S
INVOLVED IN THIS BUT WHAT YOU
CAN SEE IS THAT MANY, MANY OF
OUR CLINICAL RESEARCH STAFF HAD
THE ABILITY TO FIND OTHER WORK
AT HIGHER PAY AND THEY ALSO HAD
THE ABILITY TO FIND OTHER TYPES
OF WORK THAT ALLOW THEM TO WORK
REMOTELY.
AND ON TOP OF THAT, THERE WAS A
SIGNIFICANT AMOUNT OF BURN OUT
IN TERMS OF THE--REALLY THE LACK
OF STAFFING AND THE DIFFICULTY
IN CONDUCTING THEIR JOBS,
DAY-TO-DAY.
NEXT SLIDE.
FINALLY, IF YOU LOOK WHAT
HAPPENED, WHAT HAPPENED TO THOSE
INDIVIDUALS WHO LEFT OUR
ACADEMIC CANCER CENTERS.
AGAIN, NOT A SURPRISE THAT
ROUGHLY, 60% OF THE ATTRITION
THAT WAS DUE TO RECRUITMENT,
AWAY FROM ACADEMIC MEDICAL
CENTERS, INTO PHARMA AND CROs
AND THERE IS ALSO APPROXIMATELY
10% OF THE WORKFORCE, ACTUALLY
LEFT ACTIVE EMPLOYMENT DURING
THE PANDEMIC.
NEXT SLIDE.
WE ALSO HEARD NOT ONLY IN THE
ANSWER TO THESE QUESTIONS BUT
OTHER THINGS THAT I THINK ARE
IMPORTANT IN TERMS OF
UNDERSTANDING WHAT'S HAPPENED IN
THE LAST 3 YEARS.
WE HEARD FROM MANY CENTERS, THAT
IT WASN'T JUST A LOSS OF JUNIOR
STAFF BUT BOTH SENIOR AND
RECENTLY TRAINED STAFF, SO
EVERYONE LEFT CLINICAL TRIALS
OFFICES AND THAT MEANT THAT IT
WAS A POOL OFA QUALIFIED
CANDIDATES WERE DIFFICULT TO
FIND AND IN RESPONSE TO THE
SURVEY, THERE ARE INSTITUTIONS
AND IT'S MORE THAN 1, THAT LOST
UPWARDS OF 50% OF THEIR ENTIRE
STAFFING FOR THE CLINICAL TRIALS
OFFICE.
SO THIS REALLY MADE THEIR WHOLE
CLINICAL TRIALS OPERATION VERY
DIFFICULT TO SUSTAIN; NOT ONLY
FROM A WORKFORCE PERSPECTIVE BUT
ALSO THESE ARE IMPORTANT INCOME
STREAMS THAT ARE NECESSARY TO
SUPPORT THESE ACTIVITIES ACROSS
THE BOARD THAT HAVE MADE IT
DIFFICULT FOR MANY, MANY OF OUR
CANCER CENTERS TO CONDUCT THEIR
CLINICAL RESEARCH PROGRAMS.
NEXT SLIDE.
SO DURING THIS WHOLE PANDEMIC
THAT REALLY BROUGHT US REALLY
HAD THIS ADVERSE EFFECT ON OUR
CLINICAL TRIALS OPERATIONS, THE
NCIA CLINICAL TRIALS AND
RESEARCH ADVISORY COMMITTEE
BEGAN AS THE PANDEMIC BEGAN TO
WORK ON A NEW STRATEGIC VISION
AND I CAN TELL YOU THAT THAT
EFFORT OVER 2020 REALLY HAS
RESULTED IN MANY IMPORTANT
RECOMMENDATIONS THAT AND ALL OF
THOSE RECOMMENDATIONS HAVE BEEN
TEMPERED BY WHAT WE'VE ALL
EXPERIENCED DURING THE PANDEMIC.
NEXT SLIDE?
SO HERE ARE THE MAJOR THEMES,
AGAIN, NO SURPRISE, BUT WE
LITERALLY WANT TO REASSESS IN
THE CONTEXT OF WHAT'S HAPPENED
OVER THE LAST COUPLE YEARS HOW
WE COULD REDUCE TRIAL COMPLEXITY
AND COST.
HOW WE CAN DO THINGS BETTER FROM
A DECENTRALIZED PERSPECTIVE.
HOW WE COULD PROMOTE ACCRUAL.
HOW WE COULD APPROACH DATA
COLLECTION DIFFERENTLY.
WHAT ARE WERE THE OPERATIONAL
BURDENS TO BE DEALT WITH AND
REALLY HOW DO WE DEAL WITH THE
WORKFORCE ISSUES AND TRAINING
ISSUES THAT HAVE LED TO MANY OF
THESE PROBLEMS.
NEXT SLIDE.
SO IF I TAKE THE ENTIRE
RECOMMENDATION, IT'S ONLINE AND
HAPPY TO GET YOU A COPY.
THE IDEA FROM THIS REPORT IS
THAT WE HAD A GREAT NEED AT THE
NKRIRKS I TO DEVELOP FLEXIBLE
FASTER SIMPLER LESS EXPENSIVE
HIGH IMPACT TRIALS THAT
INTEGRATE WITH CLINICAL PRACTICE
AND TO DO THAT WE NEED TO
STREAMLINE OUR CLINICAL TRIAL
DESIGN PROCESSES, AND ESSENTIAL
POINTS AND DECREASE REGULATORY
HURDLES AND INCREASE EFFICIENCY
OF DATA COLLECTION.
NEXT SLIDE.
SO I'M GOING TO FOCUS REALLY
ONLY ON 1 MODEST--IT'S VERY
IMPORTANT BUT IT'S ONLY A PART
OF THE SERIES OF RECOMMENDATIONS
THAT ARE STRATEGIC PLANNING
GROUP BROUGHT FORWARD AND I'M
GOING TO FOCUS ON A COUPLE
THINGS THAT WE'RE DOING IN THE
AREA OF STREAMLINING CLINICAL
TRIALS AND I THINK WILL BE OF
INTEREST.
WE HAD A WONDERFUL WORKING GROUP
THAT ADDRESSED THE ISSUE OF HOW
DO WE STREAMLINE OUR TRIALS AND
WACAN WE DO NOW.
AND THIS EXPERT GROUP ANALYZED A
LARGE NUMBER OF RECENT NCTN
PHASE 3 TRIALS.
TRY TO UNDERSTAND WHAT DATA ARE
WE COLLECTING AND WHAT DATA DO
WE NODE NEED TO COLLECT AND I
WILL GO INTO THAT IN A MINUTE.
WE ALSO HAD A GROUP THAT TRIED
TO LOOK AT THE ISSUE OF THERE
ARE 2 ENORMOUS ISSUES RELATED TO
ELECTRONIC HEALTH RECORDS,
DR. BURREDON TALKED ABOUT 1
EARLIER, I WILL TALK ABOUT THE
ISSUE THAT IT GETS LESS IF YOU
WILL PLAY AND THAT IS, WE TRY TO
GET DATA OUT OF ELECTRONIC
HEALTH RECORDS FOR OUR GET THEM
OUT OF CLINICAL TRIALS TO GET
THEM IN CASE REPORTS.
BUT WE ALSO HAVE TO GET THEM
INTO ELECTRONIC HEGHT DATA
RECORDS IN TERMS OF TREATMENT
PLANS FOR THE STUDIES AND WHAT
DOES THAT INVOLVE?
AND WHAT IS INVOLVED WITH IT AND
HOW DO WE MAKE THAT ACTIVITY
THAT MUCH MORE STREAMLINED.
NEXT SLIDE.
SO WHAT ABOUT THE VALUE OF ALL
THE DATA WE COLLECT?
NEXT SLIDE.
WELL, I CAN TELL THAT YOU IN MY
CAREER, IT'S BEEN A RELATIVELY
LONG CAREER IN DOING CLINICAL
TRIALS.
I DON'T EVER RECOLLECT AN
INCREMENT OF TIME WHEN WE
DECIDED TO COLLECT LESS DAILY
BASIS THEA.
IT'S ALWAYS MORE DATA AND EVERY
ITEM, EVERY PIECE OF DATA THAT
YOU COLLECT COSTS MONEY.
AND SO, WE WANTED TO THINK ABOUT
AND TAKE AN APPROACH THAT WILL
ALLOW US TO MAKE RECOMMENDATIONS
THAT WERE IMMEDIATELY APPLICABLE
TO BASICALLY CHANGING.
AND SO WE DECIDED TO LOOK AT
NCI, CTEP SPONSORED TRIALS AND
LATE PHASE TRIALS THAT WERE
INTERVENTIONAL, FOCUSED ON
TREATMENT AND IN ADULTS BUT
IMPORTANTLY WERE IND-EXEMPT
TRIALS, TRIALS THAT DID NOT
INVOLVE THE APPLICATION OF AN
IND TO THE FDA AND THAT MIGHT BE
OF NEWS TO YOU THAT IT'S A VERY
LARGE PERCENTAGE OF THE NCTN
TRIALS AND ACCRUAL DOES NOT
INVOLVE THE SUBMISSION OF AN FDA
IND, AND IT'S SOMETHING THAT WE
COULD PERHAPS MAKE CHANGES IN,
MORE QUICKLY, NEXT SLIDE.
SO THESE ARE THE CATEGORIES THAT
WE LOOKED AT.
BASICALLY ALL THE MAJOR EFFORTS
THAT GO ON TO COLLECT ADVERSE
EVENTS, ISSUES RELATED TO WHAT
PARTS OF THE MEDICAL HISTORY ARE
IMPORTANT, CONCOMITANT
MEDICATIONS, PARTS OF THE
PHYSICAL EXAM, LAB RATOORY
TESTING, IMAGES AND PROCEDURES
AND PATIENT REPORTED DATA.
AND AS I SAY, THESE WERE LOOKED
AT ACROSS A SERIOUS OF CTN
TRIALS AND WHAT DID WE COLLECT
AND WHAT COULD WE NOT COLLECT?
NEXT SLIDE.
THIS IS JUST A SAMPLING, A LOT
OF DISCUSSION IN WHAT ARE WE
DOING IN COLLECTION OF ADVERSE
EVENTS, WE COLLECT GREAT 1 AND 2
ADVERSE EVENTS FOR IN THE LATE
STAGE TRIALS THAT INVOLVE DRUGS
THAT HAVE BEEN AROUND FOR YEARS,
WHERE THE TOXICITY PROFILES ARE
EXTREMELY WELL KNOWN, FOR NO
APPARENT PURPOSE.
EVEN WORSE, WE INFLECT THE
REQUIREMENT FOR THE ATTRIBUTION
OF THOSE ADVERSE EVENTS AND WHEN
THEY START AND WHEN THEY STOP
WITHOUT EVER ROUTINELY USING
THAT DATA IN RECORDING THE
OUTCOME EVER THESE TRIALS.
ESPECIALLY IF THIS IS
PROBLEMATIC FOR A SPECIFIC
TOXICITY TRIAL FOR A DRUG OR
TREATMENT IS WELL CHARACTER IDZ
FOR A GIVEN POPULATION.
PERHAPS EVEN WORSE, WE COLLECT
LABORATORY DATA BEYOND THE
STANDARD OF CARE THAT MAY BE
UNRELATED TO THE END POINTS OF
THE STUDY OR SAFETY MONITORING
AND IS FREQUENTLY UNFORTUNATELY
VERY UNFREQUENTLY UNUSED BUT YET
THAT DATA IS COLLECTED, PUT INTO
ELECTRONIC CASE REPORT FORMS AND
TAKES TIME.
WE COLLECT IMAGES DATA THAT
DOESN'T GET USED OR WE ASK FOR
DATA FOR IMAGING TO BE DONE
PERHAPS BEYOND THE STANDARD OF
CARE THAT MAY OR MAY NOT AFFECT
THE END POINT OF A LATE STAGE
CLINICAL TRIAL.
NEXT SLIDE.
HISTORY AND PHYSICAL
EXAMINATIONS ARE IMPORTANT.
HOW MUCH OF THAT INFORMATION IS
ACTUALLY IMPORTANT TO THE
CLINICAL TRIAL IS ABSOLUTELY
UNCLEAR.
WE ASK FOR CONCOMITANT
MEDICATIONS THAT ARE UNRELATED
TO THE OUTCOME OF THE TRIAL.
THE START DATES, THE STOP DATES
OF THESE CONCOMITANT
MEDICATIONS, PARTS OF HISTORY
THAT ARE NOT NECESSARY, VITAL
SIGNS THAT ARE TICKEN THAT ARE
NOT NECESSARY.
IT'S REALLY EXTRAORDINARY HOW
MUCH INFORMATION THAT WE COLLECT
THAT UNFORTUNATELY WHEN THE
TRIALS GET WRITTEN UP AND
REPORTED HAVE NO EFFECT ON
OUTCOME AND ARE REALLY UNUSED
AND UNNECESSARY.
NEXT SLIDE.
SO THE GOALS OF THIS ACTIVITY,
WE'VE IDENTIFIED MANY OF THESE
AREAS AND NOW, WE ARE BASICALLY
BRINGING TOGETHER A GROUP FROM
THE NCTN GROUPS AND OTHER
EXPERIENCE CLINICAL
INVESTIGATORS TO HELP US
OPERATIONALIZE STANDARDS OF
PRACTICE THAT WILL IN THE
CONTEXT OF IND-EXEMPT TRIALS
ALLOW US TO REDUCE OPERATIONAL
BURDEN OF THESE CLINICAL TRIALS
ACTUALLY MAKING IT STANDARD OF
PRACTICE NOT TO COLLECT A LOT OF
THIS DATA AND WE THINK THAT THIS
PROCESS WHICH I'M QUITE SURE
WILL BE SUCCESSFUL WILL PROVIDE
IMPORTANT INVITES THAT WILL
ALLOW US TO GO THROUGH THE SAME
PROCESS, TO SEE WHAT WE CAN DO
IN TERMS OF DECREASING THE DATA
THAT NEED TO BE COLLECTED FOR
LATE PHASE IND-SPECIFIC TRIAL
PEDIATRIC TRIALS BUT THIS ALL
REQUIRES BROAD STAKEHOLDER
ENGAGEMENT WHICH WE ARE INVOLVED
IN AT THE PRESENT TIME.
NEXT SLIDE.
>>AS DR. BURREDON POINTED OUT,
I WOULD LIKE TO MAKE A FEW
POINTS ABOUT PRAGMATICCA, YOU
MAY THINK EVERYTHING I SAID
WELL, THAT SOUNDS GOOD BUT ARE
THEY GOING TO DO ANY OF THIS?
WILL IT HAVE IMPACT IN MY
CENTER?
WELL THIS SHOWS YOU THAT THIS
TRIAL WHICH IS THE OUTGROWTH
FROM A LUNG MAP, RANDOMIZED
PHASE 2 TRIAL WITH 136 PATIENTS,
THAT SHOWED AN OVERALL SURVIVAL
ADVANTAGE OR GIVING THE
COMBINATION OF THE
[INDISCERNIBLE] THE PATIENTS
ALREADY PROGRESSED ON
IMMUNOTHERAPY, THAT WE COULD--WE
COULD DEVELOP A TRIAL THAT WILL
OPEN ALMOST CERTAINLY IN THE
NEXT 4-6 WEEKS THAT HAS A
SURVIVAL OUTPUT, SURVIVAL END
POINT WILL BE DONE WITH THE
COLLECTION OF ESSENTIALLY NO
ADVERSE EVENTS EXCEPT
HOSPITALIZATION, WHICH WILL
REQUIRE NO STUDY LAB DATA TO BE
COLLECTED OTHER THAN STANDARD OF
CARE, IMAGING TO BE PERFORMED
ORGT THAN STANDARD OF CARE, AND
WILL INVOLVE EITHER THE
INVESTIGATION ARMS, ARM OR THE
[INDISCERNIBLE] CHOICE WILL BE
POWERED TO HAVE A POOL OF 800
PATIENTS AND IF THE FDA SAYS
THERE'S A SIGNIFICANT SURVIVAL
PERCENTAGE, IT WILL LEAD TO A
STUDY IN THE PATIENT POPULATION.
THIS WILL HAVE THE SMALLEST
STUDY CALENDAR THAT ANY OF THE
CLINICAL INVESTIGATORS IN THE
NCAB HAVE EVER SEEN AND I THINK
IT'S REALLY REMARKABLE, IT'S
SOMETHING WE CAN DO AND IT'S
SOMETHING WE CAN TAKE SERIOUSLY
WITH RESPECT TO ALL THE TRIALS
SO WE CONDUCT BECAUSE THIS IS
THE KIND OF TRIAL THAT WILL
REQUIRE LESS PERSONNEL, IN AN
ENVIRONMENT WHERE HIRING AND
TRAINING THE INDIVIDUAL WHO IS
NEED CLINICAL TRIALS IS BECOMING
MORE AND MORE DIFFICULT.
NEXT SLIDE.
WE NEED TO SAY A WORD TO EACH OF
OUR STUDY BILLS, NEXT SLIDE,
BECAUSE AGAIN, THIS MAY BE
SOMETHING THAT'S SOME OF YOU ARE
VERY WELL FAMILIAR WITH AND SOME
PERHAPS NOT.
BUT, THE EXTENT OF THE CHALLENGE
OF ELECTRONIC HEALTH RECORD
SYSTEM NOT SIMPLY 1 IN WHICH
THERE WERE EXPENSIVE TO
SUBSTANTIATE AT INSTITUTIONS BUT
THE FACT IS THAT FOR EVERY CLIN
CLINICAL TRIAL AND EVERY ARM OF
EVERY CLINICAL TRIAL, THERE
NEEDS TO BE AN EXTENSIVE AMOUNT
OF WORK DONE TO PUT THESE THE
DRUG TESTING OR THE DRUG
ADMINISTRATION AND TESTING
SCHEDULES INTO THE ELECTRONIC
HEALTH RECORD.
THIS MAY SEEM VERY STRAIGHT
FORWARD, HOW MANY DRUGS COULD
THERE BE, HOW DIFFICULT COULD
THIS BE, I'M HERE TO TELL YOU
THAT THERE ARE OVER 80 DIFFERENT
POSSIBLE DATA ENTRY PATTERNS FOR
A SINGLE ADMINISTRATION OF A
SINGLE DOSE OF SIS PLATNIN.
AND WHAT THIS MEAN SYSTEM THAT
IF 1 INSTITUTION GIVES THEIR SIS
PLATIN IN NORMAL SALINE AND
ANOTHER DID IT IN HALF NORMAL
SALINE AND 1 INSTITUTION
REQUIRES 100 CCs OF FLUID AND
ANOTHER 500 CCs OF FLUID,
EVERY SINGLE STUDY ARM FOR EVERY
SINGLE DRUG NEEDS TO BE MODIFIED
BASED ON THE INDIVIDUALIZED
FORMULARYS TREATMENT PRACTICES
AT EVERY INDIVIDUAL
ORGANIZATION.
AND THE PROBLEM WITH THAT IS,
YOU CAN SAY THERE THAT'S REALLY
DIFFICULT BUT THE PROTOCOLS
THEMSELVES, THE PROTOCOLS WE
WRITE THAT MAY BE 80 OR 100
PAGES LONG, SELDOM IF EVER
OUTLINE ALL THOSE DETAILS, WHAT
KIND OF MEDIC TO BE USED, WELL
THE PROBLEM IS THAT
[INDISCERNIBLE] MAY BE STANDARD
PRACTICE AT JOHNS HOPKINS AND B
MAY BE STANDARD OF PRACTICE AT
DANA FARBER AND THE PROTOCOLS
DON'T TELL YOU WHICH TO USE OR
NOT USE AND THEY MAY CONFLICT
WITH THE FORMULAS OF THOSE
INSTITUTIONS AND THIS IS WHERE
THIS IS AN ENORMOUS BURDEN THAT
REQUIRES 20-30 HOURS OF EFFORT
TO BUILD 1 TREATMENT PLAN FOR 1
SINGLE STUDY ARM IN THE EPIC EHR
SYSTEM, IF YOU IMAGINE, 100 NEW
CTEP PROTOCOLS A YEAR, MANY OF
THEM HAVE MULTIPLE ARMS, BEING
STANTIATED AT OVER A THOUSAND
SITES AND EACH SITE HAS ITS OWN
INSTANCE OF THEIR OWN EHR, THIS
IS HUNDREDS OF THOUSANDS OF
HOURS OF TIME TO DO THIS IN A
WAY THAT EXPANDS ENORMOUS AMOUNT
OF RESOURCES EVEN FORPROTOCOLS
THAT MAY NOT ENROLL A SINGLE
PATIENT.
NEXT SLIDE.
SO ABOUT A YEAR AND HALF AGO, WE
STARTED A PILOT PROJECT WITH 10
NCI DESIGNATED CANCER CENTERS, 2
CONSORTIA THAT HAVE NOW BEEN PUT
TOGETHER INTO 1.
TRY TO BUILD A WAY TO
SYSTEMATIZE THESE DATA AND THESE
TREATMENT PLANS SO THAT THEY CAN
BE DONE IN A MODEL SYSTEM THAT
CAN BE DISSEMINATED ACROSS
CANCER CENTERS.
NEXT SLIDE.
OUR GOAL IS TO DEVELOP
REPRESENTATIONS AND PROTOCOL
SPECIFIC THERAPIES AND TO HAVE A
WAY TO PACKAGE ELECTRONICALLY
THESE RIERPTS, INFORMING THE
COMMUNITY DIRECTLY FOR EHRs OR
AT LEAST FACILITATE THE LOCAL
CUSTOMIZATION FORT TREATMENT ARM
AND IN THE END OVER A PERIOD OF
YEARS TO HAVE A LIBRARY OF
MODULES THAT CAN BE USED AND
USED OVER AND OVER AGAIN TO MAKE
THIS PROCESS SIMPLER, AND MAKE
IT EASIER TO OPEN TRIALS AND
INSTITUTIONS ACROSS THE COUNTRY.
NEXT SLIDE.
SO I WOULD LIKE TO END PRETTY
MUCH THE WAY I BEGAN AND THAT IS
TO THINK ABOUT THIS ENORMOUS
PROBLEM WITH OUR CLINICAL TRIALS
WORKFORCE AND SO YES, I THINK WE
CAN HELP THE PROCESS, AND HELP
THE ACCRUAL AND THE DATA
DEVELOPMENT AND REPORTING BY
STREAMLINING WHAT WE REQUIRE AND
WE'VE TALKED ABOUT THAT.
BECAUSE WE HAVE TO HAVE, IF WE
REPORT FEWER DATA, THEN THE
STAFFS THAT WE HAVE MIGHT BE
ABLE TO DO THEIR WORK.
BUT WE'RE GOING TO HAVE TO THINK
EVEN MORE ABOUT HOW TO MAKE
THEIR WORK ACTIVITIES MORE
FLEXIBLE, HOW TO ALIGN WHAT WE
REQUIRE WITH THE ABILITY TO
RETAIN STAFF AND WE'RE RIGHT NOW
THINKING VERY SERIOUSLY ABOUT
WAYS THAT THE NCI CAN HELP THIS
SIGNIFICANT PROBLEM.
THIS 1 IS UNDER CONSIDERATION,
IT'S A NEW TRAINING GRANT
PROGRAM TO TRY TO PRIME THE PUMP
TO HAVE A LARGER WORKFORCE IN
THIS AREA, TO BASICALLY SUPPORT
CANCER CENTERS IN THE TRAINING
OF INDIVIDUALS, MAYBE FOCUSING
ON POST BACCALAUREATE INDIVIDUAL
WHO IS WILL COME INTO THE CRA
FIELD AND THEY MAY OR MAY NOT
STAY INDEFINITELY IN INDIVIDUAL
INSTITUTIONS BUT, I THINK WE
NEED TO INCREASE THE WORKFORCE
BECAUSE THE REQUIREMENT IS NOT
GOING AWAY FOR THESE SKILLED
INDIVIDUALS AND WE NEED TO DEAL
WITH THE FACT THAT WE JUST D%N'T
HAVE THE INDIVIDUALS NECESSARY
TO FOCUS ON THE TRIALS WE WANT
TO CONDUCT.
WE ARE ALSO INITIATING A PILOT
PROJECT TO SEE ABOUT THE
FEASIBILITY OF CONDUCTING WHAT I
CALL A DEVELOPING--VIRTUAL
CLINICAL TRIALS OFFICE.
CAN WE PROVIDE THE SERVICES
NECESSARY, SOME OF THE SERVICES
TO INDIVIDUALS, INDIVIDUAL
ORGANIZATIONS THAT REALLY ARE
TREMENDOUSLY BACK LOGGED TODAY
BECAUSE OF PROBLEMS WITH
RECRUITMENT, SO WE CAN HELP THEM
GET THEIR DATA UP TO DATE, AND
THE TRIALS CAN BE CONCLUDED AND
THE OUTCOME FOR OUR PATIENTS
MADE--MADE APPROPRIATELY, AND
MUCH MORE RAPIDLY IN A PUBLIC
VENUE.
SO I APPRECIATE VERY MUCH THE
TRANCE TO UPDATE YOU AND I AM
HAPPY TO TAKE QUESTIONS.
>>THANKS, JIM.
FASCINATING WE'RE RUNNING A
LITTLE CLOSE TO THE HOUR BUT
IF--ARE THERE ANY QUESTIONS FROM
THE BOARD, I THINK WE CAN TAKE 1
IF THERE'S A BURNING QUESTION?
I GUESS FOR ME 1 QUESTION WOULD
BE, YOU KNOW I KNOW IT'S A
RECURRING THEME, RIGHT?
WE TALK ABOUT REPRESENTATION IN
CLINICAL TRIALS AND I KNOW A LOT
OF THAT ACTIVITY HAPPENS UNDER
NCORP, SO IS NCORP INTERFACING
WITH THIS AT ALL WHEN YOU TALK
ABOUT THE WORKING GROUP.
THERE ARE PROBLEMS OR ISSUES,
THE SAME ISSUES THAT YOU KNOW WE
SEE AT IN OF THE LARGER CANCER
CENTERS AND ARE THOSE 2 THINGS
INTERFACING?
>>THEY ARE TOTALLY INTEGRATED
BECAUSE THE EXACT SAME PROBLEMS
MAY BE EVEN WORSE AT SOME OF OUR
MAJOR NCORSITES IN TERMS OF
THEIR ABILITY TO ATTRACT AND
RETAIN STAFFS ARE CLEAR AND
THAT'S WHY DR. MCCASKILL
STEPHENS AND DR. MOONY AND I ARE
WORKING HAND IN HAND TO ADDRESS
THESE PROBLEMS.
>>THAT'S GREAT.
THAT'S VERY GOOD TO KNOW.
OH I SEE A CLAP AND A HAND, I'LL
NOT SURE, IF YOU HAVE 1
QUESTION, I THINK WE CAN DO THAT
1 BEFORE WE MOVE TO THE NEXT
AGENDA DO HAVE YOU A QUESTION
HOWARD?
>>YES, I DO.
JIM IS THERE ANY POSITIVE
CONSTRUCTIVE MODELS IN TERMS OF
COLLABORATIONS, CERTAINTY FROM
INDUSTRY THAT YOU WOULD LIKE TO
TO EXPRESS?
I MEAN OVER THE YEARS SOME OF
THE COMPANIES HAVE DONE?
VERY NICE THINGS IN TERMS OF YOU
KNOW ADVANCING TRIALS IN
UNDERSERVED POPULATIONS, ET
CETERA BI IN THIS, IT'S A SHARED
ISSUE WITH INDUSTRY NOW AND DO
YOU SEE ANY THAT YOU KNOW WHO
ARE LET'S SAY FORMER NCI
TRAINEES WHO REALLY DO CARE
ABOUT THE SUCCESS OF THE NCI
TRIALS THAT YOU SEE BEING DONE
OR CAN BE DONE BETTER BY
INDUSTRY?
>>SO HOWARD, I THINK WE SET OUT
ABOUT 10 DAYS AGO NOW, A LETTER
TO ALL THE NCI DESIGNATED CANCER
CENTERS TO UNDERSTAND WHETHER
THEY WOULD BE INTERESTED IN
MAKING IT, WHETHER IT WOULD BE
POSSIBLE TO REMOTELY ADDRESS
THEIR EHRs, TO BASICALLY HELP
WITH THE DATA MANAGEMENT ISSUES
INVOLVED AND I THINK THIS
IS--THIS IS REALLY SOMETHING
THAT IF WE CAN PUMMEL AT THIS
AND SHOW IT IS POSSIBLE TO HAVE
REMOTE VAF HELP WITH THE
ACQUISITION OF DATA AND NOT
REQUIRE ONSITE PERSONNEL.
THIS IS SOMETHING THAT I THINK
WILL BE OF GREAT INTEREST TO
INDUSTRY AS WELL AS TO THE NCI.
>>GREAT.
YOU KNOW YOU MIGHT CONSIDER
SENDING THAT OUT TO SOME OF THE
PATIENT ADVOCACY GROUPS YOU MAY
REMEMBER THE LEUKEMIA LYMPHOMA
FOUNDATION HAD A PILOT LIKE
THIS, I THINK AT CASE WESTERN.
>>THANK YOU.
WILL DO.
>>THANKS, HOWARD.
THANKS, JIM.
AND LOOK FORWARD TO UPDATES AND
ADVANCES IN THIS AREA.
SO WE'RE GOING TO MOVE ALONG AND
THANKS EVERYONE FOR REMAINING
ENGAGED AND FOR YOUR ATTENTION.
OUR NEXT AGENDA ITEM IS ONGOING
AND NEW BUSINESS.
SPECIFICALLY, THERE WERE 2
SUBCOMMITTEE MEETINGS EARLIER
TODAY, AND THE REPORT WAS GIVEN
BY THE SUBCOMMITTEE CHAIRS AND
AS A BOARD WE'LL NEED TO VOTE TO
ACCEPT THESE REPORTS.
THE FIRST WILL BE GIVEN BY DR. P
A SKETT WHO CHAIRS THE ADHOC
SUBCOMMITTEE ON POPULATION
SCIENCE EPIDEMIOLOGY AND
DISPARITIES.
>>THANK YOU VERY MUCH.
WE STARTED TODAY WITH REMINDING
EVERYBODY OF THE CHARGE OF THE
SUBCOMMITTEE HAD IS TO ADVISE TD
NCI AND DIRECTOR ON
OPPORTUNITIES TO ENHANCE NCI'S
CONTRIBUTION TO POPULATION
SCIENCE, EPIDEMIOLOGY AND
DISPARITIES.
WE THEN TURNED OUR TASK TO
DISCUSSING OUR FUTURE PRIORITIES
AND THESE ARE OUR MARCHING
ORDERS.
WE TALKED ABOUT THE 2 REPORTS WE
HAVE ALREADY CONCLUDED THE FIRST
BEING THE REPORT ON THE COHORTS,
CANCER COHORTS AND THE SECOND IT
WAS PRESENTED IN DECEMBER ON THE
NUMBER OF GRANTS BEING CONDUCTED
BY IN MINORITIES AND UNDERSERVED
POPULATIONS.
SO THE FIRST THING THAT WAS
RAISED WAS THAT WE MIGHT EXAMINE
THE FUNDING FOR TRAINING FOR
POPULATIONS SCIENTISTS AS THE
KO7S AND THE R25S WENT AWAY.
SO REALLY CAN WE REVISIT THIS?
WHAT IS THE LANDSCAPE AND
OPPORTUNITIES?
AND ALSO, WE TALKED ABOUT OTHER
TRAINEES WHO COULD BE E-MAILED
INTO THIS AND DR. CASTLE
MENTIONED THAT HE AND COLLEAGUES
AT NCR ARE CURRENTLY ANALYZING
THE LANDSCAPE OF THE
[INDISCERNIBLE] AS WELL AS
TRANSLATIONAL SCIENCE CANCER
PREVENTION WORKFORCE.
SO WE REALLY LIKED THAT IDEA AND
WE ARE GOING TO HAVE THIS
ANALYSIS PRESENTED THAT US IN
JUNE AT OUR MEETING AND WE ALSO
SUGGESTED THAT THE ANALYSIS
INCLUDED GRANT SUPPLEMENTS AS
WELL AS T32s, AND OTHER AREAS.
SO, ALSO A NOVEL IDEA OF
EXPANDING THE NCI CANCER BRANCH
AND FELLOWSHIP, NOT ONLY AT NCI
BUT INTO THE EXTRAMURAL
COMMUNITY.
SOME OTHER IDEAS THAT WERE ALSO
BROUGHT UP AND DISCUSSED INCLUDE
UNIFIED DESCRIPTORS FOR THE
SOCIAL DETERMINANTS OF HEALTH,
ENGAGEMENT OF--WITH REGULATORY
AGENCIES FOR EXAMPLE, TO PROVIDE
GUIDANCE ON UPTO DATE ANALYTIC
APPROACHES AND THE USE OF
REGISTRIES SUCH AS SEER TO HELP
DO SOME POST MARKETING
MONITORING.
THERE WAS A SUGGESTION OF
LOOKING AT HOW NEW TECHNIQUES
AND GERM LINE SEQUENCING AND
EPIGENOMICS HAVE EVOLVED AND
COULD THEY BE USED IN POPULATION
EFFORTS ESPECIALLY THOSE THAT
COULD BE USED TO BENEFIT
MINORITY AND UNDERSERVED
POPULATIONS.
THERE WAS A SUGGESTION TO LOOK
AT CLINICAL TRIAL ACCRUAL
INCLUDING SUPPLEMENTS AND ALSO
THE ACCRUAL THAT GETS CONDUCTED
AT CANCER CENTERS, NOT JUST
THROUGH NCORP WHICH LAST TIME WE
WERE PRESENTED WITH NCORP DATA
LOOKED LOOKED REALLY GOOD.
AND SOME SUGGESTIONS OF
INTEGRATING POP SI WITH OTHER
DISCIPLINES IN ADDITION
INCLUDING CANCER DRUG DISCOVERY
AND CARE.
SO, WHAT WE DECIDED TO DO IS AS
I MENTIONED WE'VE ASKED
DR. CASTLE AND HIS OTHER
COLLEAGUES TO COME AND PRESENT
TO US OUR JUNE MEETING ON WHAT
THEY FOUND ABOUT FROM THEIR
LANDSCAPE AND PORTFOLIO ANALYSIS
ON TRAINING.
AND IN THE MEAN TIME I WILL WORK
WITH FOLKS AT THE NCI, AS WELL
AS JOHN CARPTEN WHO KNOWS ALL OF
OUR SUBCOMMITTEES, DETERMINE THE
OTHER IERK TEMS THAT WERE
MENTIONED ARE APPROPRIATE TOPICS
FOR THE SUBCOMMITTEE TO ADDRESS,
WHETHER OTHER SUBCOMMITTEES
MIGHT CONSIDER OR WHETHER
THEY'RE ALREADY BEING ADDRESSED
BY THE NCI OR COULD BE ADDRESSED
BY THE NCI.
SO THAT IS MY REPORT, HAPPY IF I
MISSED SOMETHING FOR SOMEBODY TO
BRING THAT UP.
THANK YOU VERY MUCH.
>>THANKS ELECTRA.
ARE THERE ANY QUESTIONS FOR
DR. P A SKETT?
IF FOCUS ON THE WE WILL NEED TO
VOTE TO ACCEPT THE REPORT.
IS THERE A MOTION TO ACCEPT THE
REPORT?
>>YES, I MOVE.
>>SECOND?
>>SECOND.
>>MOVED AND SECOND.
ANY DISCUSSION?
>>OKAY, WE CAN NOW VOTE TO
ACCEPT THE REPORT.
ARE THERE ANY NAYS?
ABSTENTIONS?
AS THERE ARE NONE, PAULET?
>>YOU'RE GOOD, IT'S UNANIMOUS.
>>UNANIMOUS.
OKAY GREAT.
NEXT WE WILL HAVE ANN BARKER WHO
WILL PRESENT THE REPORT FROM THE
SUBCOMMITTEE ON PLANNING AND
BUDGET.
ANN?
>>THANK YOU VERY MUCH.
WE HAD A GOT REPRESENTATION OF
THE SUBCOMMITTEE TODAY AND WE
HAVE A LOT OF STUFF GOING ON IN
THIS SPACE RIGHT NOW, AS YOU
HEARD FROM M. K. AND ALSO FROM
OUR SUBCOMMITTEE MEETING WHERE
WE HEARD FROM OUR EXECUTIVE
SECRETARY PATRICK Mc GARY AND
HAD THE ANNUAL PLAN PRESENTED TO
THE SUBCOMMITTEE BY DIANE MARY.
SO WE OPENED THE SUBCOMMITTEE
WITH A FEW COMMENTS ON SOME OF
THESE ISSUES THAT ARE BEFORE US
RIGHT NOW.
EVERYTHING FROM THE PRESIDENT'S
YOU KNOW CHALLENGE TO ALL OF US
TO REDUCE CANCER BY 50% IN THE
NEXT 25 YEARS, WHICH SEEMS A
LONG WAY OFF BUT WE HAVE TO
START THINKING ABOUT, SHOULD
HAVE STARTED THINK BEING IT 5
YEARS AGO OR MORE.
WE'VE BEEN THINK BEING IT FOR A
LONG TIME BUT WE DON'T--THE
OTHER THING I REMINDED US ALL IS
THAT WE JUST SAW THE DAILY BASIS
THEA FROM LAST YEAR ON OUR
MORTALITY RATES AND SAW THAT THE
CANCER MORTALITY, THANKS TO A
LOT OF EFFORTS ON THE PART OF
NCI AND THE ONLY OTHER
ENTERPRISE THAT IS THE NCI AND
ITS AFFILIATES AND PARTNERS,
INCLUDING THE PRIVATE SECTOR IN
CANCER WE SAW A MORTALITY
DECREASE OF 33%.
IT'S NOT EQUALLY DIVIDED AMONGST
THE CANCERS OBVIOUSLY AND A LOT
OF THAT 33% COMES FROM SMOKING
PROGRAMS AND THEY'VE WORKED.
AND WE'RE BEGINNING TO SEE THE
RESULTS OF OUR INVESTMENTS IN
OMICS AND WITH THE OMICS AND
OTHER AREAS OF BASIC BIOLOGY ARE
STARTING TO AFFECT SURVIVAL
ESPECIALLY IN CERTAIN CANCERS,
BREAST CANCER BEING 1 OF THOSE
THAT'S VERY SIGNIFICANT.
WELL, I ALSO POINTED OUT THAT
SOMETIMES THEY'RE UNTOWARD
AFFECTS OF THINGS THAT WE MAY
THINK WE KNOW ABOUT BUT MAYBE WE
DON'T AND THAT IS WHEN YOU
CHANGE SCREENING PROTOCOLS AS WE
DID FOR PROSTATE CANCER ABOUT 3,
4 YEARS AGO, WHAT HAPPENS IS, IT
COMES OUT IN SOME OTHER PART
OBVIOUSLY, VERY HIGHLY CONNECTED
SYSTEM IN THIS CASE, SEEING A
LOT OF ADVANCED PROSTATE CANCER
IN THE LAST 3 YEARS WHICH IS
IMPACTING MORTALITY.
SO A LOT OF THINGS ARE GOING ON
AND LAST BUT NOT LEAST IS THE
ISSUE OF THE PRESIDENT
MENTIONING, I THINK
REAUTHORIZATION OF THE NATIONAL
CANCER ACT.
I DON'T KNOW WHAT THAT MEANS BUT
FROM A FINANCIAL STANDPOINT IT
REALLY WOULD CHANGE A LOT OF
THINGS IN TERMS OF OUR ANNUAL
PLAN.
SO IN TERMS OF SOME HIGHLIGHTS,
PATRICK Mc GARY OUR EXECUTIVE
CHAIRMAN FOR THIS PARTICULAR
SUBCOMMITTEE PRESENTED A LOT OF
DATA AND IT WAS ALL PRETTY GOOD
NEWS FOR THIS YEAR, I THINK, WE
PROBABLY--YOU KNOW MAYBE HAD 1
OF THE BEST YEARS WE'RE GOING TO
SEE HOPEFULLY IT'S NOT THE BEST
YEAR WE'LL EVER SEE BUT IT'S
PRETTY GOOD.
WE AWARDED 7500 NEW GRANTS.
THAT'S AN AMAZING, AMAZING
PROBABLY THE BEST 1 WE'VE EVER
HAD AND IT MEANT THAT WE REACHED
THE 12th PERCENTILE AND YOU'LL
RECALL WE DID HAVE A GOAL BACK
UNDER NED'S LEADERSHIP WHERE WE
WERE VECTORING TOWARD 15% BY
2025, YET TO BE SEEN IF WE WILL
MAKE THAT.
THAT WILL REQUIRE QUITE A BIT OF
FUNDING.
AS WAS POINTED OUT TO US ALL,
ANYTIME WE APPROVE THIS MANY
GRANTS WITH 5 OR 7 YEAR
OUTLOOKS, IT ALL ROLLED THROUGH
THE SYSTEM FOR THE NEXT 5 YEARS
SO IT MAKES IT VERY, VERY
DIFFICULT TO THINK ABOUT HOW WE
FUND ADDITIONAL IDEAS AND
GRANTS.
AND SO SOMETHING WE HAVE TO
THINK ABOUT IS, AS WE FIGURE OUT
HOW WE CAN HELP THROUGH THIS
SUBCOMMITTEE, THE NEW NCI
DIRECTOR AND THE WHOLE OF THE
NCI'S BUDGET.
A COUPLE THINGS CAME UP THAT I
THOUGHT WERE KIND OF INTERESTING
HERE AND THAT IS THE ANNUAL PLAN
WHICH HAS BEEN AROUND SINCE
1971, WE CALL IT THE BYPASS
BUDGET FOR MANY YEARS HAS, I
THINK NOT--IT HAS BT RECEIVED
MUCH ATTENTION UNTIL I THINK THE
LAST 3-4 YEARS AND IF YOU LOOK
AT THIS YEAR'S PLAN, WHICH IS BY
THE WAY, JUST OUTSTANDING, IT'S
VERY EASY TO READ, IT'S ONLINE,
CAN YOU GO SEE IT, YOU SHOULD
DRIEWBT IT IN YOUR CANCER
CENTERS OR LABORATORY SO PEOPLE
ARE ALL IN THE SAME PAGE, BUT
IT'S 10 BILLION DOLLARS.
I MEAN THAT'S KIND OF WHAT IT
WOULD TAKE OPTIMALLY FOR US TO
MEET THE GOAL WE WANT TO MEET.
A YEAR FROM NOW OR A LITTLE MORE
THAN A YEAR FROM NOW, THAT'S NOT
VERY MUCH MONEY AND IT INVOLVES
4 SPECIFIC AREAS, CELLULAR
THERAPIES, TARGETING THE
UNTARGETTABLE, REALLY PUTTING
MONEY UNDERNEATH THE KINDS OF
THINGS THAT ELECTRA'S
SUBCOMMITTEE TALKS ABOUT AND
THAT'S REALLY SOLVING THIS,
LET'S DELIVER TO THE MINORITY
AND UNDERSERVED COMMUNITIES AND
THOSE CANCERS WHERE WE DON'T
HAVE SCREENINGS VERY
INTERESTING.
SO THE 4 AREAS, THERE COULD BE
OTHER 4 AREAS, 5 KREBS CYCLE
AREAS, 10 AREAS, WHATEVER, THOSE
ARE 4 HIGHLIGHTED AREAS AND YOU
COULD THINK OF LOTS MORE, BUT
THIS IS THE KIND OF THING WE
SHOULD BE PLANNING MUCH FURTHER
THAN WHAT YOU HEARD TODAY.
THE DR. BERTAGNOLLI'S GOING TO
HELP US IN THAT REGARD.
IT'S NOT ALWAYS POSSIBLE TO KNOW
WHAT OUR LINES ARE IN TERMS WHAT
HAVE WE CAN DO TBH THIS SPACE
BECAUSE WE'RE ALL SPECIAL
GOVERNMENT EMPLOYEES.
WE DON'T PARTICIPATE IN THE
KINDS OF THING LIKE WHAT PAULET
JUST READ TO YOU WHEN SHE READ
HER LONG DESCRIPTION SO HOW CAN
OUR SUBCOMMITTEE HELP?
AND WE HEARD FROM MONITORRIC AND
AND THANK HER VERY MUCH FOR
JOINING US, SHE WILL BE
CHALLENGING US TO THINK ABOUT
WHERE CAN WE REALLY HAVE AN
IMPACT HERE IN TERMS OF LOOKINGA
THE SOME OF THESE ISSUES TO HELP
NCI, TO ASK BETTER QUESTIONS, TO
ACTUALLY PRIORITIZE, I THINK
PRIORITIZATION WILL BE CRITICAL
AND SO A COUPLE OF IDEAS CAME UP
AND SOME OF YOU HAVE SENT ME
IDEAS BUT WE REALLY WANT TO
THINK ABOUT HOW WE FUND SOME OF
THIS UNDERREPRESENTED
CONVERSATION THAT WE HAVE ALL
THE TIME, I MEAN WE REALLY NEED
TO DO SOMETHING ABOUT DELIVERY
TO THESE AND THE AFRICAN
AMERICAN, YOU KNOW ALL OF THOSE
SUBPOPULATIONS WE KEEP TALKING
ABOUT, HOW DO WE DO THAT?
ASK THEN, THE WHOLE ISSUE CANCER
CENTERS AND INFRASTRUCTURE
AROUND US AS YOU HEARD FROM
DR. BERTAGNOLLI, HOW DO WE KEEP
UP IN THE DATA SCIENCE AREAS, ET
CETERA.
SO IT WAS A GOOD MEETING.
I WANT THANK OUR PRESENTERS
TODAY WHO WAS REALLY AN
INFORMATION MEETING GOING FROM
HERE'S WHERE WE ARE AND TO
HERE'S WHERE WE REALLY NEED TO
BE ON AN ANNUAL BASIS IN TERMS
OF OUR ANNUAL PLAN AND I THOUGHT
THAT WAS VERY GOOD CONTINUUM TO
START TO THINK ABOUT HOW DO WE
GO FROM WHERE WE ARE TO ACHIEVE
THAT ANNUAL PLAN TO FUND THE
THINGS WE NEED TO FUND.
AND IN ADDITION TO THANKING
DIANE FOR HER EXCELLENT
PRESENTATION, THANKS TO PATRICK
WHO IS RETIRING FROM PATRICK
FROM THE NCI AND FEDERAL SERVICE
HAVING SPENT 2 DECADES ON TAP
TOLL-LIKE RECEPTOR HILL, 13
YEARS AT THE FDA AND 10 YEARS
ADDED THE NCI AND I WANT THE
WHOLE BOARD TO THANK YOU
PATRICK.
YOU'VE BEEN SUCH A GREAT ASSET
TO ALL OF US AND WE WISH YOU
WELL IN YOUR CAREER.
AND THAT'S MY REPORT.
>>THANKS, ANN.
IT'S REALLY, REALLY A CRITICALLY
IMPORTANT ASPECT OF THIS.
YOU KNOW WITHOUT A PLAN AND
WITHOUT BUDGETS, YOU KNOW HOW DO
YOU GET ANYTHING DONE, RIGHT?
AND I THINK ELECTRA'S BEEN
THROWING AROUND THIS WORD,
DISRUPT, RIGHT?
IS SEEMS LIKE 1 OF THE HARDER
AREAS TO DISRUPT, BUT, YOU KNOW
IT--
>>IT'S GOING TO BE DISRUPTED.
IT'S GOT TO BE DISRUPTED.
>>YES.
>>WE NEED TO START WITH THE
10 MILLION, BECAUSE WHEN YOU
THINK OF CANCER GOING UP 30% IN
THIS COUNTRY AND UP TO 75% ON A
GLOBAL BASIS, WE CAN'T AFFORD
NOT TO DO IT.
>>AGREED.
AGREED.
OKAY, WELL, THANKS, ANN.
ARE THERE ANY OTHER QUESTIONS
FOR ANN REGARDING HER REPORT?
NO?
THEIR BEING NONE, WE ALSO NEED
TO VOTE ON THIS REPORT.
SO IS THERE A MOTION TO APPROVE
OR ACCEPT THE REPORT?
OKAY, IS THERE A SECOND?
OKAY.
PROBABLY MOVED AND SECOND.
ANY DISCUSSION?
IF THERE IS NONE, WE NEED TO
THEN VOTE TO ACCEPT THE REPORT.
I WILL ASK ARE THERE ANY NAYS?
ABSTENTIONS?
>>IT'S UNANIMOUS.
>>THANK YOU PAULET.
>>AND NOW, WE NEED TO MOVE ON
TO EVERYONE WAS SENT AND SHOULD
HAVE RECEIVED A MISSION
STATEMENT THAT ADDRESS TD THE
ESTABLISHMENT OF AN AD HOC
REVIEW GROUP FOR EVALUATION OF
THE SCIENTIFIC DIRECTOR OF THE
NCI CENTER FOR CANCER RESEARCH
SCIENTIFIC DIRECTOR.
SO, YOU ALL SHOULD HAVE RECEIVED
THAT--
>>EXCUSE ME.
EXCUSE ME.
>>IT'S MORE THAN 1.
>>THE SCIENTIFIC DIRECTORS.
>>YES, WITH AN S.
>>RIGHT.
>>WITH AN S.
I APOLOGIZE FOR MY DICTION, I
APOLOGIZE.
SO YOU SHOULD HAVE ALL RECEIVED,
I DON'T HAVE TO READ THIS.
ARE THERE ANY QUESTIONS RELATED
TO THE MISSION STATEMENT THAT
YOU ALL SHOULD HAVE RECEIVED?
YES, MARGARET?
>>I DON'T RECALL US RECEIVING
SOMETHING LIKE THIS IS THIS
SOMETHING NEW OR HAVE I BEEN
MISSING PREVIOUS MISSION
STATEMENTS?
>>NO, IT'S NOT NEW, IF YOU
RECALL WE DID 1 FOR THE
SCIENTIFIC DIRECTOR OF THE
DIVISION OF ACADEMIA
[INDISCERNIBLE] ABOUT 6 MONTHS,
12-6 MONTHS AGO.
AND SO LOOKING AT CCR.
YES.
>>OKAY.
>>YEAH, SO THIS IS INTRAMURAL.
>>CORRECT.
>>DID YOU CALL FOR THE VOTE?
>>SO, YEAH, I'M GOING TO
NEED--IS THERE A MOTION TO
APPROVE?
>>APPROVE.
>>OKAY, WE HAVE A MOTION FOR
MARGARET.
IS THERE A SECOND?
>>OKAY, THIS IS MOVED AND
SECOND.
DISCUSSION?
IF NOT, WE CAN VOTE TO APPROVE
THE MISSION STATEMENT.
I WILL ASK IF THERE ARE ANY
NAYS?
ANY ABSTENTIONS?
THERE BEING NONE.
>>IT'S UNANIMOUS.
OKAY, GREAT.
SO PRIOR TO ADJOURNING THE OPEN
SESSION, I HAVE TO ASK IF THERE
ARE OTHER ISSUES THAT ANYONE
MIGHT WANT TO HAVE ADDRESSED
BEFORE WE,A JOWRN?
--ADJOURN?
I JUST WOULD LIKE TO THANK
EVERYONE FROM THE NCI AND M. K.
AND AGAIN, VERY INFORMATIVE
PRESENTATIONS, A LOT OF ACTIVITY
AND LOOKING FORWARD TO UPCOMING
PRESENTATIONS COMING OUT OF THE
NCI.
IF THERE ARE NO ADDITIONAL
QUESTIONS OR ARE THERE ANY
SUGGESTIONS FOR FUTURE AGENDA
ITEMS?
SO I HAVE 1, I THINK IT CAME UP
REGARDING, YOU KNOW, I THINK IT
WAS PART OF EXPECTATIONS LECT
RA'S PREVIOUS REPORT ON SORT OF
GATHERING INFORMATION ON VARIOUS
FUNDING MECHANISMS THAT GO INTO
FOR INSTANCE DISPARITIES
RESEARCH AND SO 1 OF THE THINGS
THAT WILL BE INTERESTING TO SEE
IS I THINK 1 WHERE IS THE MONEY
GOING?
LIKE, YOU KNOW, IF WE WERE TO
LOOK ACROSS CANCER CENTERS,
LOOKING AT FUNDING LEVELS TO
CANCER CENTERS, AND THEN, WE
LOOK AT THOSE CANCER CENTERS,
HOW MUCH OF THE RESEARCH IS
GOING INTO DISPARITIES TYPE
RESEARCH AND THAT COULD BE
ACROSS POPULATION SCIENCE,
EPIDEMIOLOGY, TRANSLATIONAL
BASIC SCIENCES OR CLINICAL
BECAUSE IT WOULD JUST BE
INTERESTING TO SEE, IF WE LOOKED
AT FUNDING LEVELS AS A WHOLE
ACROSS CANCER CENTERS, THEN
BEGIN TO ASK THE QUESTION, HOW
MUCH FUNDING ARE GOING INTO
THOSE CENTERS THAT'S ASSOCIATE
WIDE THE RESEARCH AND TO
UNDERREPRESENT MINORITIES CANCER
DISPARITIES, HEALTH EQUITY.
YEAH, ELECTRA IN.
>>YEAH, SO OUR REPORT DID THAT
ON THE MACROLEVEL.
>>RIGHT.
I WANT TO SEE IT ON THE MICRO.
>>YOU COULD TAKE THOSE THAT
WERE ALREADY IDENTIFIED AND
AGAIN, THAT'S FISCAL YEAR 21 AND
THEN YOU KNOW I'M SURE THEY
COULD BE ASSIGNED BY CANCER
CENTER.
IS THAT SORT OF WHAT YOU'RE
THINKING ABOUT.
>>YEAH, YEAH.
IT WOULD BE GREAT TO SEE THAT.
>>WE DID IT BY OUR--THE
POPULATIONS THAT THE WORKING
GROUP DECIDED TO EXAMINE AND IF
YOU RECALL THERE WERE SOME
GROUPS THAT EITHER THERE WAS
LIMITED DATA OR BE--THERE ARE NO
CODE WORDS TO BE ABLE TO DO THE
SEARCH.
SO WE WERE SORT OF LIMITED BUT
WE HAD ENOUGH THAT YOU COULD
THEN TAKE THOSE AND YOU WOULD
HAVE TO DECIDE, DO YOU CARE?
WE DID IT ALSO ACROSS THE CANCER
CONTINUUM SO YOU WOULD NEED TO
DECIDE IF YOU WANTED THAT OR
JUST TOTAL BY CANCER CENTER.
>>YEAH, I THINK IT WOULD BE
INTERESTING JUST TO SEE BY
CANCER CENTER, AS JUST THE PLACE
TO START.
>>YEAH.
>>AND I DON'T KNOW IF DENEEZ IS
STILL ON BUT HER GROUP IS THE 1
THAT DID THE ANALYSIS.
>>I HAVE 1 OTHER QUESTION AND
AGAIN, I GUESS IT'S JUST
PARTIALLY MY IGNORANCE AND I
PROBABLY SHOULD KNOW THE ANSWER.
YOU KNOW WHEN WE LOOK AT SORT OF
TOTAL RO-1 FUNDING AND THEN WE
LOOK AT FUNDING FOR ESIs, IT
ALWAYS SEEMS TO BE LIKE A 5%
DIFFERENCE, I DON'T KNOW, MAYBE
I'M MISSING SOMETHING, IS THAT A
FIXED DELTA OR IS IT AN
ARBITRARY DELTA?
MEANING, COULD THAT BE 8% OR 10%
OR I MEAN IS THAT 5% A SET--I
SAW DINA NODDING HER HEAD.
DOES ANYONE KNOW THE ANSWER TO
THAT?
>>JOHN THIS, IS DOUG.
>>HEY, DOUG.
>>THE 5% IS SOMETHING THAT NCI
DECIDED TO DO A NUMBER OF YEARS
AGO.
THERE IS CONSIDERABLE
FLEXIBILITY BETWEEN 0 AND LET'S
SAY 10%.
I DON'T KNOW WHETHER THERE IS
SOMETHING YOU WOULD NEED TO
APPLY TO THE OFFICE OF
EXTRAMURAL RESEARCH IF YOU WANT
TO GO TO 30% OR SOMETHING LIKE
THAT.
>>[LAUGHTER]
NO, I WAS JUST WONDERING BECAUSE
WE ALL SORT OF WISH FOR THIS 15%
FUNDING INCREASE, IT BECOMES A
GOAL, BUT THE QUESTION IS IF THE
OVERALL REMAINSA AT 12 COULD THE
ESI GO TO 20 AS A CONCESSION OF
SORTS TO INSURE THAT OUR EARLY
STAGE INVESTIGATORS CONTINUE TO
ENGAGE.
>>THIS WAS A DIRECT RESPONSE TO
OUR HAVING SUCH A LOW PAY LINE
FOR INVESTIGATORS IN GENERAL, WE
WANTED TO ADVANTAGE THE ESIs
AND IT LAZ --HAS LED TO A
SUBSTANTIAL INCREASE IN THE
TOTAL NUMBER OF ESI,A WARDS AND
THE PERCENTAGE OF ESI AWARDS
COMPARED TO ALL OF THE AWARDS
THAT WE MAKE.
, THAT'S GREAT.
THANKS, DOUG.
SO I SEE A FEW HANDS, I WANT TO
START WITH LOUIS SINCE HE HAS
NOT HAD A QUESTION TODAY.
LUIS, YOU MUST BE MUTED.
WE CAN'T HEAR YOU.
YOU'RE STILL MUTED.
I WONDER IF IT'S YOUR MIC.
TYPE IT IN THE CHAT.
THAT WOULD BE GREAT.
HOWARD?
>>SURE.
I'M WONDERING TO ADD TO YOUR
SUGGESTION, JOHN, I WAS THINKING
ABOUT I THINK IF WOULD BE
INFORMATIVE TO ALSO UNDERSTAND
THESE RELATIONSHIPS IN WHO GETS
TREAT TD AND THE CANCER CENTERS
TO THE MORE MODERN UPDATED
TREATMENTS, I'M THINKING
ESPECIALLY ABOUT CAR-T THERAPIES
AND THE ATC CENTERS THAT ARE
ASSIGNED TO BE ABLE TO DELIVER
THEM.
THERE WAS AN INTERESTING POSTER
PRESENTATION AT ASH THIS YEAR
JUST A MONTH AGO BY FRED LOCK
WHO'S BEEN FOLLOWING THIS AND
HAS EXPERIENCE WITH THE
[INDISCERNIBLE] TRIALS SHOWING
SOME RELATIONSHIPS
GEOGRAPHICALLY TO WHO HAS ACCESS
TO THESE MORE MODERN TYPES OF
THERAPY AND WHO DOESN'T.
AND I THINK THIS WOULD FIT WELL
WITH SOME OF THE THINGS WE WERE
TALKING ABOUT BEFORE IN THE
COMMITTEE.
>>THANKS HOWARD.
THAT'S GREAT.
THERE MAY BE TIME I THINK FOR
THE 1 LAST QUESTION, ANNA, WE'RE
AT ABOUT 2 MIVENUTES OUT FROM
ADJOURNING.
>>ANN?
>>SO I'M A BROKEN RECORD BUT I
WILL ASK ONCE AGAIN THAT I THINK
THAT WE'RE ASLEEP AT THE WHEEL
IN THIS WHOLE ISSUE OF EARLY
CANCER DETECTION TESTS.
IT IS POTENTIALLY TRANSFORMATIVE
AND I'VE HAD QUESTIONS FROM
PEOPLE SAYING, WHOSE'S DOING,
YOU KNOW THE STUDY THAT INCLUDES
THE SCIENCE WHICH IS PROFOUND,
THE CLINICAL TRIALS THAT HAVE TO
BE DONE HERE AND HOW MUCH
THEY'RE GOING TO COST, THE CARE
AND DELIVERY THAT NOW THE LEVELS
OF COMPLEXITY IN CARE DELIVERY
ARE GOING TO CHANGE ENORMOUSLY
FOR PEOPLE TAKING CARE OF
PATIENT WHO IS HAVE CANCER AND
THOSE WHO WERE TOLD THEY WERE
GOING TO GET CANCER AND THERE'S
THIS OVERALL ISSUE OF HOW
PATIENTS ARE GOING TO RESPOND
AND WE ALREADY SEE PEOPLE
REIMBURSING FOR THESE TESTS NOW.
IT'S LET'S SEE 2 OR 3 HOSPITAL
SYSTEMS HAVE COME OUT OR BIG
INSURANCES HAVE COME OUT IN THE
LAST MONTH.
I THINK THIS--THIS IS IT'S AN
NCI ISSUE, I THINK THERE SHOULD
BE A VERY COMPREHENSIVE STUDY OF
THIS AND WE HAVE TO FIGURE OUT
WHICH PIECE OF THIS BELONGS TO
THE NCI AND WHERE CAN OTHER
PARTS OF IT GO.
I THINK WE'RE GOING TO GET AHEAD
OF THIS 1 AND I DON'T HAVE AN
ANSWER.
THIS IS PROBABLY 1 OF THE MOST
COMPLEX ISSUES THAT'S EVER
BECOME BEFORE THIS BOARD.
I HONESTLY THINK WE NEED TO PUT
OUR STAKE INDEED GROUND HERE AND
SAY WE'RE DOING SOMETHING.
>>YEAH, IT'S A BROAD ISSUE
BECAUSE EVEN IF YOU DETECT IT
THEN HAVE YOU IT FIGURE OUT WHAT
DO YOU DO NEXT.
AND SO, YOU KNOW AGAIN, - IT IS
A REALLY IMPORTANT ISSUE AND
IT'S SOMETHING I AM HOPING.
>>YOU GOTTA START.
YOU GOTTA START JOHN.
>>YOU HAVE TO BE DISRUPTIVE.
>>WE CAN BRING IN THE ACADEMY
AS WELL.
>>OKAY, WE'RE RIGHT AT THE
ADJOURNMENT MARK.
I SEEN MONICA'S HAND UP, I FEEL
HORRIBLE.
>>SO I JUST WANT TO VERY
QUICKLY ANSWER ANNA BECAUSE WE
AGREEN CELLS ENTIRELY, WE HAVE A
VERY DEDICATED TALENTED TEAM
WORKING ACROSS THE ENTIRE
COMMUNITY ON TO DO EXACTLY WHAT
YOU ASKED ANNA, WE DO NOT HAVE
THE FUNDING.
WE DO NOT EVEN COME CLOSE TO
HAVING THE FUNDING TO ACHIEVE
WHAT YOU'VE ASKED.
SO WITHOUT SUBSTANTIAL NEW
FUNDING WE WILL NOT BE ABLE TO
CONDUCT THAT RESEARCH.
>>AWESOME.
>>THOSE TRIALS ARE GOING TO BE
HORRIBLY EXPENSIVE.
>>SOUNDS LIKE A GREAT
OPPORTUNITY FOR PUBLIC-PRIVATE
PARTNERSHIP.
SO, WHY DON'T WE GO AHEAD AND
ADJOURN.
IF THERE ARE ANY OTHER
QUESTIONS, PLEASE OR ISSUES OR
TOPICS PLEASE SEND THEM OVER TO
EITHER ME OR PAULET AND WE WILL
MAKE SURE THEY GET ON THE AGENDA
FOR THE NEXT MEETING.
SO THIS CONCLUDES THE OPEN
SESSION.
THERE WILL BE A 20 MINUTE BREAK.
ONLY BOARD MEMBERS AND
DESIGNATED NCI STAFF SHOULD
REMAIN ON.
ALL OTHERS SHOULD SIGN OFF NOW.
AND THOSE THAT ARE ATTENDING THE
CLOSED SESSION SHOULD SIGN ON
WITHIN THE NEXT 20 MINUTES USING
THE TEPERATE WEB EXPECTATIONS
CONNECTION THAT WAS SENT TO
EVERYONE.
SO, THE CLOSED SESSION WILL
BEGIN PROMPTLY AT 3:50.
[MEETING ADJOURNED ]