... THE EX OFFICIO MEMBERS,
PRESIDENT CANCER MEMBER STAFF
AND GUESTS, THERE ARE REQUIRED
ANNOUNCEMENTS.
MEMBERS OF THE PUBLIC MAY WISH
TO EXPRESS THEIR VIEWS REGARDING
ANY ITEMS DISCUSSED DURING THIS
MEETING MAY WRITE TO DR.
PAULETTE GRAY, EXECUTIVE
SECRETARY OF THE BOARD, WITHIN
TEN DAYS AFTER THE MEETING.
ANY WRITTEN STATEMENTS OR
QUESTIONS SUBMITTED BY MEMBERS
OF THE PUBLIC WILL RECEIVE
CAREFUL CONSIDERATION.
AS BOARD MEMBERS, I
WANT TO REMIND YOU YOU MUST
ABSENT YOURSELVES ON A
PARTICULAR PRODUCT, PROGRAM, OR
OTHER SPECIFIC MATTER WHERE IT
WOULD CONSTITUTE CONFLICT OF
INTEREST OR CREATE THE
APPEARANCE OF ONE.
IT'S INCUMBENT ON YOU TO ABSTAIN
FROM PARTICIPATION AND
DISCUSSION OR ACTION REGARDING
THAT MATTER.
IN LIGHT OF THE CURRENT POLICIES
CONFLICT OF INTEREST BASED ON
FINANCIAL HOLDINGS FOR SPECIAL
GOVERNMENT EMPLOYEES WHICH
INCLUDES ALL MEMBERS OF THE
BOARD WE MUST DEPEND ON YOU TO
VOLUNTARILY ABSTENT YOURSELVES
DURING DISCUSSIONS OF MATTERS
THAT COULD IMPACT THE STATUS OF
THESE HOLDINGS.
WE THURSDAY YOUR JUDGMENT SO
PLEASE MAKE SURE TO ABSTAIN WHEN
APPROPRIATE.
DURING ANY CLOSED SESSIONS, ANY
MATERIALS OR DISCUSSIONS OF A
CONFIDENTIAL NATURE DELIBERATED
ON TODAY ARE PRIVILEGED
INFORMATION AND MAY ALSO BE
AVAILABLE TO YOU ON A
NEED-TO-KNOW BASIS, SUCH
DELIBERATIONS ARE PRIVATE AND
THEIR CONTENTS SHOULD NOT BE
DIVULGED.
SO, WE HAVE THE FUTURE MEETING
DATES, PROVIDED TO YOU AND ARE
ALSO LISTED ON THE AGENDA SO
THAT YOU CAN SEE WHEN OUR NEXT
MEETINGS ARE, JOINT MEETINGS,
NCAB MEETINGS.
SO NEXT UP IS APPROVAL OF THE
SUMMARY FOR THE DECEMBER 7-9,
2021, JOINT BSA/NCAB VIRTUAL
MEETING.
I'D LIKE TO ASK DO WE HAVE A
MOTION TO APPROVE THE SUMMARY?
A SECOND?
>> SECOND.
>> DISCUSSION?
SO, PLEASE VOTE YAY, NAY, OR
ABSTAIN.
DO WE HAVE ANY NAYS?
THANK YOU.
SO BY LAW, A QUORUM IS REQUIRED
FOR A VOTE TO OCCUR, WHETHER IN
OPEN OR CLOSED SESSION.
DURING THIS MEETING MINIMUM OF
NINE APPOINTED MEMBERS OF THE
NCAB MUST BE PRESENT TO VOICE
THEIR VOTES.
SINCE WE CAN'T PREDICT THE TIME
OR OCCURRENCE OF ANY MOTION,
YOUR PRESENCE IN THE VIRTUAL
ROOM FOR ALL SEGMENTS OF THE
MEETING IS NECESSARY, AND IT'S A
MUST.
PAULETTE, DO WE HAVE A QUORUM?
>> YES, WE DO.
>> TO ENSURE NO INTERRUPTIONS
DURING THE MEETINGS, PLEASE
ENSURE THAT YOU ARE MUTED AND
REMAIN SO UNTIL RECOGNIZED BY
EITHER ME, PAULETTE, NED OR THE
SPEAKER.
AND WE ALWAYS HAVE THE CELL
PHONE ISSUES BUT MAKE SURE
YOU'RE MUTED.
NEXT ITEM OF BUSINESS ON OUR
AGENDA WILL BE THE NCI
DIRECTOR'S REPORT PROVIDED BY
DR. NED SHARPLESS, DIRECTOR OF
THE NCI.
NED?
>> THANKS, JOHN.
GOOD AFTERNOON, EVERYONE.
GOOD TO SEE YOU AGAIN VIRTUALLY.
I WANT TO APOLOGIZE TO THE
GLOBAL HEALTH SUBCOMMITTEE FOR
ZOOM BOMBING THEIR MEETING.
I HAD COMPUTER DRAMA BUT I
BELIEVE IT'S FIXED.
I ASSUME YOU CAN HEAR ME.
>> YES.
>> GREAT.
SO I THOUGHT I WOULD TALK ABOUT
THE PAST, NCA 50 BRIEFLY ON
THAT.
A LITTLE BIT ABOUT FY 22, STILL
VERY MUCH CURRENT TOPIC OF
BUSINESS, AND M.K. HOLOHAN WILL
TALK ABOUT THAT AND PRESIDENT'S
ANNOUNCEMENT AROUND THE NEW
CANCER MOONSHOT, SUPER CHARGED
MOONSHOT AS THE PRESIDENT CALLS
IT AND LEAVE TIME FOR
DISCUSSION.
NEXT SLIDE PLEASE.
WHEN WE LAST MET AS A WHOLE
GROUP IN EARLY DECEMBER WE WERE
STILL A FEW WEEKS OUT FROM THE
ACTUAL SIGNING OF THE NATIONAL
CANCER ACT ON DECEMBER 23, A
REALLY GREAT I THINK SORT OF
TSUNAMI OF INTEREST ACROSS THE
CANCER RESEARCH COMMUNITY WITH
GREAT BUY IN FROM EVERYONE
INTERESTED IN CANCER RESEARCH TO
TALK ABOUT THIS AREA, INCLUDING
GREAT PICKUP IN THE MEDIA.
WE WERE DELIGHTED WHEN THE FIRST
LADY PROVIDED A WONDERFUL VIDEO
IN HONOR OF THE 50th
ANNIVERSARY, ENUNCIATED PROGRESS
THAT REMAINS AND SOME CHALLENGES
THAT REMAIN BUT ALSO TALKING
ABOUT PROGRESS.
I'D LIKE TO PLAY IT BRIEFLY --
PLAY IT IF THE A V TEAM COULD
QUEUE THIS UP
>> RESEARCHERS, POLICYMAKERS,
PATIENTS, SURVIVORS.
50 YEARS AGO A DEDICATED
COALITION OF ADVOCATES CAME
TOGETHER TO WITNESS PRESIDENT
NIXON SIGN THE NATIONAL CANCER
ACT OF 1971.
ON THAT DECEMBER DAY, THE UNITED
STATES WROTE THE FIRST CHAPTER
IN OUR UNIFIED FIGHT AGAINST
CANCER.
SINCE THEN, WE'VE INVESTED IN
PEOPLE AND SCIENCE, ADVANCING
CANCER SCREENING, PREVENTION,
DIAGNOSIS, AND TREATMENT.
WE'VE HELPED MILLIONS OF
PATIENTS LIVE LONGER, FULLER
LIVES.
BUT DESPITE OUR TREMENDOUS
PROGRESS, THE HEARTBREAKING
REALITY IS THAT CANCER IS STILL
A LEADING CAUSE OF DEATH IN OUR
COUNTRY.
WE STILL DON'T HAVE ENOUGH
METHODS TO PREVENT IT.
SOME TREATMENTS COME WITH
SERIOUS SIDE EFFECTS.
AND INEQUITIES LEAD TO FAR TOO
MANY LIVES LOST.
IN 1971, THEN-PRESIDENT NIXON
CALLED FOR A TOTAL NATIONAL
COMMITMENT TO FINDING A CURE.
NOW, WE'RE READY TO DO MORE.
TO END CANCER AS WE KNOW IT.
IT'S AN AMBITIOUS GOAL, BUT FROM
BRILLIANT RESEARCHERS TO
PASSIONATE PROVIDERS TO INFORMED
AND ENGAGED PATIENTS, I'VE SEEN
THE HEART AND GRIT OF OUR
COMMUNITIES.
THERE IS NOTHING OUT OF OUR
REACH.
CANCER IS PART OF THE BIDEN
FAMILY STORY.
IT'S PART OF SO MANY AMERICAN
STORIES.
CANCER TOUCHES US ALL.
BUT TOGETHER WE CAN CHANGE THAT
STORY.
WE CAN END THE TRAGEDY OF CANCER
AS WE KNOW IT.
AND NOTHING WILL STOP US.
>>AS I SAID, WE FOUND THAT
TREMENDOUSLY COMPELLING AND ARE
GRATEFUL FOR THE WHITE HOUSE'S
SUPPORT, PARTICULARLY THE FIRST
LADY'S. A REAL FRIEND OF CANCER
RESEARCH.
SO LET ME BRIEFLY SAY A COUPLE
WORDS ABOUT 22, STILL A TOP
ORDER OF BUSINESS AS I SAID M.K.
WILL HAVE MORE TO SAY.
AS A REMINDER I TRY AND SHOW
THIS SLIDE WHEN I SPEAK TO THE
NCAB.
YOU SEE OUR ALLOCATION FOR THE
LAST COUPLE YEARS AS WELL AS THE
PRESIDENT'S BUDGET MARK AND
HOUSE MARK FOR 2022 TO THE FAR
RIGHT, ORANGE BARS REPRESENTING
THE 21st CURES WHICH FUNDED
ORIGINAL CANCER MOONSHOT AND $50
MILLION IN 20 FOR THE CCDI, END
OF ITS SECOND YEAR, WHITE BOX TO
INDICATE ONE-TIME MULTI-YEAR
FUNDING FOR CORONAVIRUS RESEARCH
THAT THE NCI CONTINUES TO DO.
WE'RE STILL IN A CONTINUED
RESOLUTION.
WE'VE HAD SOME MEMBERS OF THE
CONGRESS TALK ABOUT THE
POSSIBILITY EVEN OF A FULL YEAR
CONTINUING RESOLUTION WHICH
WOULD BE VERY PROBLEMATIC FOR
THE NCI.
WE'VE SEEN PROGRESS AND
OPTIMISTIC STUFF IN THE LAST FEW
WEEKS THAT M.K. WILL TALK ABOUT.
BUT THIS, YOU KNOW, LACK OF
HAVING A 22 BUDGET AS YOU CAN
IMAGINE PROVIDES SOME BUDGETARY
CHALLENGES AND PLANNING
CHALLENGES FORT NATIONAL CANCER
INSTITUTE, MOST IMPORTANT IS
SHOWN ON THE NEXT SLIDE.
WHICH IS WE STILL OPERATE UNDER
THESE VERY LOW INTERIM PAYLINES
FOR 2022, 19th AND 14th,
FUNDING NON-COMPETING AT 90%
DURING THIS PERIOD OF
UNCERTAINTY.
WE HOPE AND BELIEVE THAT ONCE
BUDGET IS PASSED WE WILL BE ABLE
TO IMPROVE THESE INTERIM
PAYLINES AND PARTICULARLY
IMPROVE THE FUNDING FOR
NON-COMPETING GRANTS.
BUT WE'RE NOT OUT OF THE WOODS
YET.
I HAD THE OPPORTUNITY TO TALK TO
ONE OF THE APPROPRIATORS, TOM
COLE, ABOUT THIS.
AND AT THE CANCER MOONSHOT
EVENT.
HE TOLD ME THAT HE THOUGHT THEY
WOULD GET A BUDGET.
THEY ARE MAKING PROGRESS, BUT
THE FULL YEAR C.R. IS STILL
SOMETHING WE HAVE TO WORRY B
STAY TUNED.
M.K. WILL HAVE MORE TO SAY.
I WANT TO POINT TO THIS IN
SCIENTIFIC AMERICA BY SENATOR
COONS AND MORAN, TALKING ABOUT
THE SUPPORT THEY THINK CONGRESS
SHOULD PROVIDE TO REALLY HELP US
BEAT CANCER AS THEY CALL IT.
IT'S GREAT TO HEAR THIS KIND OF
BIPARTISAN INTEREST IN
SUPPORTING CANCER RESEARCH, THEY
AT THE SAME TIME QUEER -- WE'RE
BEGINNING TO DISCUSS WHAT COMES
NEXT IN THE CANCER MOONSHOT.
YOU CAN SEE THE WHITE HOUSE IS
INTERESTED IN ENDING CANCER,
MAKING PROGRESS, CONGRESS HAS
SHOWN WILLINGNESS OVER SEVERAL
YEARS AND INTEREST IN PROVIDING
FOR CANCER RESEARCH PERSISTING
THROUGH TODAY AND WE HAVE A
COMMUNITY OF RESEARCHERS AND
SCIENTISTS AND PATIENT ADVOCATES
THAT WANT TO DO THAT TOO.
THE STARS ARE FAVORABLY ALIGNED
FOR PROGRESS AGAINST CANCER.
NEXT SLIDE.
WE HAD THIS EVENT WEDNESDAY
WHERE PRESIDENT BIDEN ANNOUNCE
PLANS TO SUPER CHARGE THE CANCER
MOONSHOT, A BIG MOMENT FOR
NATIONAL CANCER INSTITUTE AND IN
GENERAL, PRESIDENT SAID FIGHTING
CANCER IS A TOP PRIORITY,
EXPRESSED EXUBERANCE FOR THE
PROGRESS OF THE CANCER MOONSHOT.
IT'S IMPORTANT TO NOTE THE
SUCCESS OF THE MOONSHOT LAUNCHED
IN 2016 LED BY DR. DINAH SINGER,
A CONTRIBUTING FACTOR TO
PROGRESS OVER FIVE YEARS, THIS
IS WHAT THE PRESIDENT POINTED TO
AS ENABLING THIS BROADER AND
MORE AMBITIOUS SET OF GOALS.
THE EVENT LAST WEDNESDAY WAS THE
KICKOFF, STEP ONE, HE LAID
IMPORTANT GOALS AND TALKED ABOUT
HIS PRIORITIES.
I'VE SEEN FIRST HAND THE PASSION
AND COMPASSION OF TH BIDEN, THIS
IS A POWERFUL EXAMPLE OF THEIR
COMMITMENT.
THIS TRANSCENDS ALL OF
GOVERNMENT, BIGGER THAN ANY ONE
AGENCY OR OFFICE.
I HAVE COMPLETE CONFIDENCE
PRESIDENT BIDEN WILL ENSURE THIS
STAYS ON TRACK, CHANGING THE
EXPERIENCE OF PATIENTS WITH
CANCER.
HE DESCRIBES HIS AS A
WHOLE-OF-GOVERNMENT APPROACH.
YOU CAN SEE IN THE PHOTOGRAPH TO
THE LEFT SEVERAL CABINET
SECRETARIES.
HE'S CONVENING A CANCER CABINET,
THE NCI IS HONORED TO BE PART
OF, TO BRING TOGETHER
DEPARTMENTS AND AGENCIES TO HELP
ESTABLISH AND MAKE PROGRESS ON
THE GOALS OF ENDING CANCER AS WE
KNOW IT, INCLUDING 19 AGENCIES
SUCH AS HHS, DoD, CMS, CDC,
EPA, VA AND OTHERS.
IT'S CLEAR NCI WILL BE PRIMARILY
RESPONSE BUT THIS IS BIGGER THAN
RESEARCH FOR THE NATIONAL CANCER
INSTITUTE.
IT'S NOT JUST DEVELOPING NO
TREATMENTS AND PREVENTION, IT'S
ENSURING ACCESS AND IMPROVING
HEALTH CARE DELIVERED WITHIN
COMMUNITIES AND PROMOTING HEALTH
EQUITY.
WE'LL SEE A LOT OF NEW IDEAS
COME OUT OF THE CANCER CABINET
AND I'M EXCITED FOR THIS
ANNOUNCEMENT AS WELL.
NEXT SLIDE.
I WANT TO REMIND EVERYONE WE'RE
STILL VERY EXCITED ABOUT
MOONSHOT, 1.0, THAT'S VERY MUCH
A WORK IN PROGRESS, WHERE THE
NCI IS PROUD OF THIS RESEARCH,
CREATING 70 CONSORTIA, MORE THAN
70, FUNDING MORE THAN 240 NEW
RESEARCH PROJECTS, WORKING ON A
VARIETY OF AREAS IN THE
TRANSLATIONAL SPACE.
YOU CAN SEE THE FUNDING FOR THAT
INITIATIVE SUNSETS IN 2023, A
GREAT TIME TO TALK ABOUT SUPER
CHARGING THE MOONSHOT.
NEXT SLIDE.
AND SO WE HAVE THOUGHT A LOT
WORKING WITH COLLEAGUES IN THE
WHITE HOUSE ABOUT WHAT IT WOULD
MEAN TO END CANCER AS WE KNOW
IT.
AND IF YOU WATCH THE EVENT, OR
READ ABOUT IT AFTERWARD, YOU SAW
HOW NEW GOALS ARE BEING
PRESENTED, FURTHER REFINEMENT OF
REALLY UNDERSTANDING HOW WE KNOW
CANCER TODAY AND HOW WE CAN WORK
TO TRANSFORM THAT REALITY.
SO A FEW OF THESE DESCRIPTIONS
ARE SHOWN, TO GIVE YOU A SENSE
OF SOME AREAS BEING ENVISIONED,
NOT EVERY PROMISING AVENUE IS
CALLED OUT, BUT TAKEN TOGETHER
THIS BEGINS TO PRESENT A PICTURE
OF THE SCALE AND SCOPE OF THE
VISION AND DIRECTIONS UNDERSTOOD
TO BE IMPORTANT AND PROMISING.
I MIGHT ARGUE THIS IS DIFFERENT
FROM THE WAY WE OFTEN FRAME
OPPORTUNITIES WITHIN THE
SCIENTIFIC COMMUNITY SO I THINK
WE'RE PRONE TO TALK ABOUT LIKE
TARGETING RAS OR UNDERSTANDING
TUMOR MICROENVIRONMENT OR
ELUCIDATING THE INTERPLAY OF
MULTIPLE TRANSCRIPTION FACTORS
IN A CELL.
THOSE ARE WORTHY GOALS,
IMPORTANT WAY OF DOING SCIENCE,
BUT WHAT WE'RE REALLY DOING HERE
IS WHAT THE NEXT PHASE OF THE
MOONSHOT IS DOING INTENTIONALLY,
LOOKING AT WHAT CANCER IS TODAY
AND HOW PATIENTS EXPERIENCE IT,
AND HOW WE CAN CHANGE WHAT IS A
TRAGIC DIAGNOSIS FOR MANY
PATIENTS THAT AFFECTS THEIR
LIVES DAY IN AND DAY OUT.
AND SO THESE BEGIN TO REFLECT
THINKING OF NCI AND WHITE HOUSE,
MORE WORK TO COME IN THESE
AREAS.
SO ONE IMPORTANT WAY TO SORT OF
TALK ABOUT CHANGING THE
EXPERIENCE OF CANCER IS
EXAMINING THIS THROUGH THE PRISM
OF CANCER MORTALITY IN THE
UNITED STATES.
I TALKED ABOUT THIS A LOT BEFORE
BUT I THINK IT CONTINUES TO BE A
REALLY GOOD METRIC TO THINK
ABOUT PROGRESS IN CANCER BECAUSE
IT'S NOT BIASED BY LEAD TIME
BIAS OR SCREENING BIAS.
YOU KNOW, IT'S AN AREA, IT'S A
METRIC WE COLLECT ANNUALLY, AND
LOOK AT VERY CAREFULLY ALONG
WITH THE CDC AND OTHER AGENCIES,
AND SO I THINK IT IS A GREAT WAY
TO TALK ABOUT WHAT CANCER
PROGRESS MIGHT LOOK LIKE.
SO YOU CAN SEE HERE DATA FROM
2005 TO 2019, A VERY STRIKING
DECLINE IN AGE-ADJUSTED CANCER
MORTALITY ACROSS THE UNITED
STATES.
BUT YOU CAN ALSO NOTE THERE'S A
LOT OF HETEROGENEITY EVEN
PERSISTING TODAY, SOME STATES
THAT HAVE HIGH RATES OF CANCER
MORTALITY RELATIVE TO OTHER
STATES THAT HAVE QUITE LOW
RATES.
WHILE THERE'S PROGRESS MADE
ACROSS THE COUNTRY, THAT
PROGRESS IS NOT EVEN.
AND THIS BEGINS TO MAKE YOU
HELP -- HELPS ONE UNDERSTAND THE
COMPLEXITY OF THE METRIC LIKE
CANCER MORTALITY AND CHALLENGES
OF MAKING PROGRESS.
I WANT TO THANK NDCCPS FOR
HELPING ME ORGANIZE THESE DATA.
THE PRESIDENT AND COLLEAGUES IN
OSTP HAVE DECIDED CANCER
MORTALITY GOAL IS THE RIGHT WAY
TO THINK ABOUT IT.
THIS IS ONE OF THE MAJOR
ANNOUNCEMENTS LAST WEEK.
THE PRESIDENT SET A GOAL TO
REDUCE DEATH RATE FROM CANCER BY
AT LEAST 50% OVER THE NEXT 25
YEARS.
SO REDUCTION OF AGE ADJUSTED
MORTALITY FROM THE MOST RECENT
RATE OF 146 PER 100,000 TO 73
PER 100,000, PUTTING CANCER
LOWER AS CAUSE OF MORTALITY
NATIONALLY, REPRESENTING A
CHANGE IN THE EXPERIENCE OF
CANCER NATIONALLY AND WOULD BE A
CRUCIAL STEP I WOULD THINK
TOWARDS ENDING CANCER AS WE KNOW
IT.
I BELIEVE THIS IS A BOLD GOAL
BUT I ALSO COMMEND THE PRESIDENT
FOR ENUNCIATING AN ACHIEVABLE
GOAL, NOT A PIE IN THE SKY
WE-CAN'T-DO-THING, IT HAS
DECLINED SUBSTANTIALLY SINCE
1990s, WE CAN CONTINUE AND
ACCELERATE TO MEET THE GOAL OF
THE WHITE HOUSE.
NEXT SLIDE AS I SAID, LOOKING
BACK AT MORTALITY AGAIN,
PROMOTING HEALTH EQUITY IS A BIG
PART OF ENDING CANCER AS WE KNOW
IT.
I DON'T THINK THE PRESIDENT
MEANT ENDING CANCER AS WE KNOW
IT FOR SOME PEOPLE.
HE WAS CLEAR HE WANTS ALL
AMERICANS TO BENEFIT FROM THIS
PROGRESS, AND SO ONE HAS TO TAKE
AN HONEST LOOK ABOUT THE TOPIC
OF HEALTH INEQUITIES IN OUR
COUNTRY, AS INFLUENCED BY THINGS
LIKE RURALITY, POVERTY, IN THIS
CASE RACE AND ETHNICITY.
I SHARE MORTALITY DATA, THEY
WERE COMPLICATED WHEN YOU ADD IN
GEOGRAPHY FOR ALL-COMERS, BUT BY
RACE AND ETHNICITY THE STORY IS
FURTHER COMPLICATED.
NON-HISPANIC BLACK PATIENTS HAVE
WORSE OUTCOMES, EVEN THOUGH
THERE'S IMPROVEMENT.
GEOGRAPHIC DISPARITY FOR
AGGREGATE DATA AND DIFFERENT
POPULATIONS.
NON-HISPANIC AMERICAN
INDIAN/ALASKA NATIVE, NOT
HOMOGENUS, STARK DIFFERENCES
DEPENDING ON GEOGRAPHY, AAIN
LOOK GOOD, AND OTHER PLACES THEY
ARE NOT.
THINGS LIKE TOBACCO USE, ON
FEBRUARY 5 NAVAJO NATION ENACTED
FIRST BAN ON TRIBAL LAND,
IMPORTANT IN TERMS OF CANCER
THERE.
TO ACHIEVE MORTALITY GOALS WE
HAVE TO TACKLE INEQUITIES, HAVE
TO MAKE PROGRESS FOR THOSE
AMERICANS THAT HAVE THE WORST
OUTCOMES BECAUSE OF LACK OF
ACCESS OR STRUCTURAL RACISM OR
POVERTY OR WEALTH OR EDUCATION
OR THINGS THAT PROVIDE -- THAT
CREATE THESE CANCER HEALTH
DISPARITIES.
NEXT SLIDE.
ONE OF THE THINGS THE WHITE
HOUSE HAS BEEN TALKING A LOT
ABOUT AS A FOCUS OF THE NEXT
CANCER MOONSHOT IS PREVENTION,
SCREENING, EARLY DETECTION.
THESE ARE IMPORTANT TOOLS FOR
CONTROLLING CANCER AT THE
POPULATION HEALTH LEVEL.
AND TACKLING SOME OF THESE
INEQUITIES I MENTIONED REQUIRES
CLOSING GAPS IN SCREENING
BEHAVIORS FOR EXAMPLE.
THE PANEL TOOK THIS TOPIC ON AND
HAS RELEASED THEIR REPORT
SHINING A SPOTLIGHT IS A
SCREENING, IDENTIFYING KEY GAPS,
BARRIERS, PROVIDING
RECOMMENDATIONS TO INCREASE
EQUITABLE ACCESS.
YOU SEE EDITH MITCHELL, JOHN
WILLIAMS AND MYSELF AT THE
MOONSHOT EVENT, TWO OF THE THREE
MEMBERS OF THE PANEL.
EARLY DETECTION TO REDUCE NEED
FOR AGGRESSIVE THERAPIES THAT
LOWER QUALITY OF LIFE AND
INCREASE FINANCIAL BURDEN.
AND THEIR REPORT CITES BARRIERS,
IDENTIFIES LACK OF KNOWLEDGE OF
GUIDELINES, LACK OF PROVIDER
RECOMMENDATIONS, FEARS OR
CONCERNS ABOUT MEDICAL
PROCEDURES, DIFFICULTY
NAVIGATING HEALTH SYSTEM,
LOGISTICAL CHALLENGES INCLUDING
LACK OF TRANSPORTATION AND
PARKING, LACK OF ACCESS TO
MEDICAL SERVICES.
THE REPORT MAKES RECOMMENDATIONS
ON HOW TO HELP ALL AMERICANS
BETTER UNDERSTAND WHEN AND HOW
THEY SHOULD BE SCREENED AND HOW
TO IMPROVE ACCESS TO CANCER
SCREENING THROUGH COMMUNITY
ORIENTED OUTREACH AND EXPANSION
OF SELF-SAMPLING TO SCREENING
FOR CERVICAL AND COLON CANCER.
IT RECOMMENDS HEALTH CARE
SYSTEMS SET UP SYSTEMS THAT
ALLOW ALL MECHANICS -- MEMBERS
TO SUPPORT CANCER SCREENING AND
MAKE IT A PRIORITY, PARTICULARLY
GIVEN THE LAST TWO YEARS OF
PANDEMIC THAT WE'VE HAD WITH
ERRATIC EFFECT ON CANCER
SCREENING.
NEXT SLIGHT.
NEXT SLIDE.
HERE IS THE PLUMMET IN TERMS OF
SCREENING RATES THAT OCCURRED
EARLY IN THE PANDEMIC AND REALLY
HAVE NOT RECOVERED.
AND YOU SEE THE PRESIDENT'S CALL
TO ACTION IN THIS AREA, NOTING
OVER THE PANDEMIC PERIOD WE
MISSED MORE THAN 9 MILLION
SCREENINGS FOR CANCER, HAVE TO
GET THOSE BACK ON TRACK FOR
BREAST CANCER, COLON CANCER,
CERVICAL, LUNG CANCER.
IN SOME ASPECTED UNDERUTILIZED
PRIOR TO THE PANDEMIC.
WE NEED TO RECOVER AND INCREASE
WHAT WE WERE DOING FOR LUNG
CANCER SCREENING FOR INSTANCE.
THE PRESIDENT CALLED FOR
ENSURING EVERYONE IN THE U.S.
EQUITABLY BENEFITS FROM
SCREENING AT HOME, MOBILE
SCREENING IN COMMUNITIES WITHOUT
ACCESS TO CLINIC, COMMUNITY
HEALTH NETWORKS, OTHER IMPORTANT
WAYS TO REDUCE BARRIERS TO
SCREENING.
NCI WILL WORK WITH DESIGNATED
CANCER CENTERS AND OTHER
NETWORKS TO MAKE CLEAR THAT
CANCER SCREENING IS A NATIONAL
PRIORITY TO AFFECT CANCER
MORTALITY AT THE POPULATION
LEVEL.
NCI WILL COLLECT DATA TO
UNDERSTAND THE NEED AND
DISSEMINATE DATA IN PARTNERSHIP
WITH OTHER PARTS OF GOVERNMENT
LIKE CMS, HRSA, CDC.
NEXT SLIDE.
ONE AREA OF INTEREST ACROSS THE
FEDERAL GOVERNMENT CONTINUES TO
BE THE TOPIC OF MULTI-CANCER
DETECTION TESTS.
THESE ARE THESE TESTS THAT HAVE
THE POTENTIAL TO DETECT MANY
CANCERS SIMULTANEOUSLY IN A
BLOOD-BASED ASSAY IN AN
OTHERWISE HEALTHY INDIVIDUAL.
AND IF THE TESTS WORK, TO THE
EXTENT WE WOULD HOPE, WE HAVE
POTENTIAL TO REDUCE CANCER
MORTALITY.
THE WHITE HOUSE ANNOUNCED
FEDERAL AGENCIES LED BY NCI WILL
DEVELOP A FOCUS PROGRAM TO STUDY
AND EVALUATE MULTI-CANCER
DETECTION TESTS.
BUT THESE TESTS REQUIRE RIGOROUS
TESTING AND I DON'T THINK WE CAN
ASSUME THAT THESE THINGS WILL
NECESSARILY WORK.
SCREENING AND EARLY DETECTION
HAS POTENTIAL FOR OVERDIAGNOSIS,
OVERTREATMENT, CAN THEREFORE
CAUSE HARM.
ONE STEP THE NCI HAS MADE IS
DROP THE E.
IT'S USUALLY MCED, DOUG LOWY
POINTED OUT EARLY CANCER IS NOT
PROVEN YET AND CONVINCED US TO
CALL IT MULTI-CANCER DETECTION
TESTS.
TO HELP US THINK ABOUT THIS
PORTFOLIO, WE TALKED ABOUT THIS
BEFORE, IT CONTINUES AN AREA OF
MAJOR INTEREST.
NEXT SLIDE.
WE CONTINUE -- I'LL SHOW WORK
FROM THE INTRAMURAL PROGRAM THAT
WE THINK COULD BE IMPORTANT IN
TERMS OF THE PRESIDENT'S GOALS
OF ENDING CANCER AS WE KNOW IT.
WITH REGARD TO PREVENTION
THERE'S AN INTERESTING STUDY
CO-AUTHORED BY DCCPS, DCEG, CDC,
IT TALKS ABOUT POTENTIAL PUBLIC
HEALTH BENEFITS OF CHANGING
DAILY PHYSICAL ACTIVITY, US
ACCELEROMETER INFO, DATA FROM
NHANES OF 4800 ADULTS 40-85,
INCREASED ACTIVITY ASSOCIATED
WITH DECREASE IN NUMBER OF
DEATHS PER YEAR.
ONE WEEK OF MONITORING MAY NOT
REFLECT CHANGES OVER TIME, CAN'T
ESTABLISH CAUSALITY.
MORE RESEARCH IS NEEDED, WE
THINK THIS IS AN IMPORTANT AND
POTENTIALLY ACTIONABLE RESULT.
WE BELIEVE ACTIVITY IN PART
AFFECTS OBESITY, WHICH IS A
GROWING PROBLEM IN THE UNITED
STATES, AND IT'S BECOME ONE OF
THE LEADING MODIFIABLE BEHAVIORS
IN TERMS OF CANCER RISK,
THEREFORE ACTIVITY MAY PLAY A
ROLE IN REDUCING THE MORTALITY,
POPULATION LEVEL MORTALITY
ASSOCIATED WITH CANCER.
SMALL AMOUNTS OF ADDITIONAL
ACTIVITY CAN REALLY MAKE A
DIFFERENCE.
NEXT SLIDE.
TO END CANCER WE'LL NEED TO
DEVELOP NEW THERAPEUTICS.
SO THERE'S A LOT GOING ON IN ANY
AREA IN CANCER RESEARCH AND I
THINK THIS IS ONE OF THE
IMPORTANT REASONS WE ALSO HAVE
SUCH A PASSION, STRONG SUPPORT
OF THE NCI FOR INVESTIGATOR
INITIATED BASIC CANCER BIOLOGY,
THE SUBSTRATE FOR NEW
DISCOVERIES.
AS YOU SEE EVERY WEEK, THERE'S
NEW EXCITING IDEAS IN TERMS OF
CANCER THERAPY.
STEVE ROSENBERG ARE TWO PAPERS
OUT, TUMOR INFILTRATES, THIS WAS
PATIENTS WITH REFRACTORY BREAST
CANCER THAT FAILED MULTIPLE
PRIOR TREATMENTS, STILL A VERY
IMPORTANT CAUSE OF CANCER DEATH,
STEVE USES THESE PERSONALIZED
TUMOR INFILTRATING LYMPHOCYTES
TO TREAT THESE PATIENTS WITH
METASTATIC BREAST CANCER.
THE RESULTS, TRIAL IN THE
CLINICAL CENTER, RESEARCHERS
ADVOCATE WHOLE GENOME SEQUENCING
TO IDENTIFY MUTATIONS FOR 42
WOMEN.
THEY ISOLATED TILLs FROM TUMOR
SAMPLES, TEST THE REACTIVITY
AGAINST NEOANTIGENS AND SHOWED
MORE THAN 2/3 OF THE WOMEN, 28
OUT OF 41 WITH METASTATIC BREAST
CABER IS HAD TILs THAT
RECOGNIZED ONE NEOANTIGEN AND
GENERATED EVIDENCE OF IMMUNE
REACTION.
SO FOR SIX WOMEN THEY WERE ABLE
TO REINFUSE TILs THEY HAD
GROWN IN THE LAB, AND RETURN
THEM TO THE PATIENT WITH
TREATMENT FOR THE CHECKPOINT
INHIBITOR TO PREVENT TIL
EXHAUSTIONS, TUMOR SHRANK IN
THREE OUT OF SIX, A PROMISING
SET OF STUDIES IN A HIGHLY
TREATED POPULATION.
AND SHOWS POWER OF FINDING
ANTI-CANCER IMMUNE CELLS, EVEN
IN PEOPLE WHO WOULDN'T HAVE
THOUGHT WOULD BE GOOD CANDIDATES
FOR IMMUNO-ONCOLOGY.
SECOND POWER IN "SCIENCE,"
EXPRESSION PROFILES OF
TUMOR-SPECIFIC TILs, SO THEY
FOUND TCR CLONOTYPES, SINGLE
CELL TRANSCRIPTOME
TRANSCRIPTOMIC ANALYSIS,
IDENTIFYING THOSE CAPABLE OF
INDUCING ANTI-TUMOR RESPONSE AND
MAKES THEIR PRODUCTION AND
SELECTION MUCH SIMPLER, AN
IMPORTANT STEP TO BRING TILs
TO MORE GENERAL USAGE.
RIGHT NOW THIS IS HIGHLY
COMPLICATED SCIENCE DONE IN THE
INTRAMURAL PROGRAM AT NCI BUT IF
THIS IS GOING TO BECOME SCALABLE
THESE ARE IMPORTANT RESEARCH
QUESTIONS TO ADDRESS.
NEXT SLIDE.
EFFORTS TO END CANCER MUST ALSO
ACCOUNT FOR DIFFERENCES IN
SPECIFIC POPULATIONS, FROM
HEALTH DISPARITIES PERSPECTIVE
AND POPULATION PERSPECTIVE.
THE NCI IS COMMITTED TO
UNRAVELING CHILDHOOD CANCER,
CHILDREN ARE NOT JUST LITTLE
ADULTS, EFFORTS IN THE CHILDHOOD
CANCER DATA INITIATIVE
DEMONSTRATED UNIQUE
OPPORTUNITIES AND SIGNIFICANT
CHALLENGES THAT REMAIN BEFORE
US.
AND I FELT LIKE I NEEDED MORE
HELP THINKING THROUGH THESE
PEDIATRIC CANCER ISSUES.
TO END I'M PLEASED TO ANNOUNCE
DR. WILDMANN WILL ASSUME A
LEADERSHIP ROLE AND GIVE ADVICE
TO NCI DIRECTOR.
SHE'S A PRACTICING PEDIATRIC
ONCOLOGIST, FAMILIAR WITH NCI'S
ENTIRE CHILDHOOD CANCER RESEARCH
PORTFOLIO AND WILL BRING
VALUABLE CLINICAL AND SCIENTIFIC
PERSPECTIVES ON RESEARCH GAPS
AND GAPS IN TREATMENT.
SHE WILL CONTINUE HER POSITION
AS HEAD OF THE PHARMACOLOGY AND
EXPERIMENTAL THERAPEUTICS
SECTION, CHIEF OF PEDIATRIC
ONCOLOGY BRANCH, IN ADDITION
GIVING ADVICE, PIONEERING
RESEARCH ON NEUROFIBROMATOSIS,
RESULTING IN MEDICAL THERAPY FOR
CHILDREN LAST YEAR, VERY
EXCITING DEVELOPMENT ON A
CONGENITAL CANCER SYNDROME
DISCOVERED DECADES AGO BY
FRANCIS COLLINS.
HER WORK IN THIS AREA LED TO HER
NOMINATION FOR A SAMI, SERVICE
TO AMERICA AWARD, COMES AT A
GREAT TIME, A TIME OF GREAT
PROGRESS AND OPPORTUNITY IN
CHILDHOOD CANCER RESEARCH, SO
WE'RE EXCITED ABOUT HAVING HER
WISDOM TO HELP NOW.
NEXT SLIDE.
I WANT TO BE SURE TO EMPHASIZE
ESPECIALLY IN LIGHT OF EVENTS
THIS WEEK ONE THING THE NCI IS
ABOUT, WE'RE UNEQUIVOCALLY
COMMITTED TO ENSURING CIVILITY,
KINDNESS, IN OUR WORKPLACE, CORE
VALUES AT THE NCI AND NIH.
WE BELIEVE THIS IS HOW PEOPLE DO
THEIR BEST WORK.
THE NCI IS NOT A PLACE WHERE WE
TOLERATE BULLYING OR HARASSMENT
OF ANY KIND.
NIH POLICY IS CLEAR.
AND IS SHOWN IN A STATEMENT FROM
LARRY TABAK, IT WILL NOT BE
TOLERATED, TIMELY ACTION WILL BE
TAKEN AGAINST ANY INDIVIDUAL
FOUND TO BE IN VIOLATION OF THIS
POLICY.
AT NCI WE HAVE A WORKPLACE
CIVILITY AND ANTI-HARASSMENT
PROGRAM COORDINATED BY A
WORKPLACE CIVILITY COMMITTEE
MADE OF SENIOR REPRESENTATIVES
ACROSS THE NCI DIVISION AND
CENTERS, COMMUNICATED CLEAR
POLICIES AND PROVIDED TOOL KITS
AND TRAINING, INCORPORATED
ANTI-HARASSMENT INTO ONBOARDING
AND EMPLOYEE PERFORMANCE
EVALUATIONS.
WE HAVE CHANNELS ACCESSIBLE FOR
ANYONE WHO EXPERIENCES
HARASSMENT TO REPORT IT SAFELY
AND DISCREETLY WITHOUT FEAR OF
RETALIATION.
WE TAKE TIMELY AND APPROPRIATE
ACTION TO RESPOND TO ALL REPORTS
AND WE TAKE THIS COMMITMENT
SERIOUSLY, BELIEVING DOING SO IS
ESSENTIALLY TO FULFILLING OUR
GOAL TO ENABLE ALL STAFF TO
BRING THEIR BEST SELFS TO REACH
THEIR POTENTIAL AND CONTRIBUTE
TO OUR MEMBER TO REDUCE CANCER'S
BURDEN.
NEXT SLIDE.
I'D LIKE TO CLOSE WITH MORE
REFLECTION ON RECENT EVENTS AS I
HAVE SAID, I'VE BEEN SO
IMPRESSED BY THE FIRST LADY'S
GRASP OF CANCER RESEARCH, GRACE
AND SINCERITY.
LAST WEEK WE ECHOED THAT WE'RE
IN A GOLDEN AGE OF CANCER
RESEARCH, SPEAKING VOLUMES.
SHE AND THE PRESIDENT ARE FIRED
UP ABOUT THE NEED TO MAKE
PROGRESS IN KIDS CANCER, THEY
BELIEVE THE TIME IS NOW TO MAKE
THAT PROGRESS AND SUCCEED.
IT'S HARD NOT TO BE INSPIRED BY
THAT.
I FOUND THIS SO INVIGORATING AND
IT WAS SO GOOD TO GALVANIZE ALL
OF US INTERESTED IN PROGRESS FOR
OUR PATIENTS.
NEXT SLIDE.
ALSO AT THAT EVENT VICE
PRESIDENT HARRIS SPOKE ABOUT HER
MOTHER'S WORK AS A CANCER
RESEARCHER, HER MOTHER'S DEATH
DUE TO COLON CANCER AND YOU
COULD HEAR HER RESPECT AND LOVE
FOR HER MOTHER AND PASSION AND
COMMITMENT TO MAKING PROGRESS
AGAINST CANCER, SHE SAID THIS
FOCUS ON THE CANCER MOONSHOT
DEMONSTRATES WHO WE ARE, I
QUOTE, IN AMERICA WE NOT ONLY
DREAM, WE DO.
WE NOT ONLY SEE WHAT CAN BE, WE
SEE WHERE WE WANT TO GO IN A WAY
WE CAN REACH FOR THE MOON AND
PLANT OUR FLAG ON IT.
A GREAT REMINDER OF THE POINT OF
THE MOONSHOT, WHY THE PRESIDENT
AND WHITE HOUSE LIKE THIS
METAPHOR, TALKS ABOUT
GALVANIZING ALL ACROSS FEDERAL
GOVERNMENT FOR THIS SHARED
MISSION TO END CANCER AS WE KNOW
IT.
WITH THAT I WILL CLOSE AND I
HOPE I'VE LEFT TIME FOR
QUESTIONS.
THANK YOU.
>> GREAT.
THANKS, NED.
TOUR DE FORCE.
WE HAVE 10 OR 11 MINUTES FOR
SOME QUESTIONS.
IF YOU HAVE A QUESTION, PLEASE
USE THE REACTION TOOL AND RAISE
YOUR HAND.
YOU'LL BE PRIORITIZED AND I CAN
SEE IT.
I'LL TAKE PRIVILEGE AND ASK A
QUESTION, NED.
MOONSHOT IS DEFINITELY A HUGE
ENDEAVOR, HUGE INITIATIVE,
REQUIRES A LOT OF SUPPORT.
THE SUPPORT FROM THE PRESIDENT
AND THE FIRST LADY AND VICE
PRESIDENT WAS PALPABLE IN THAT
ROOM.
AND, YOU KNOW, BUT I WOULD LIKE
TO ASK YOU A QUESTION.
IT'S RELATED TO THE MOONSHOT.
THE RECENT NEWS ABOUT ERIC, DR.
LANDER, HOW HIS RESIGNATION
COULD IMPACT THE MOONSHOT GIVEN
HIS ROLE AS SCIENCE ADVISER AND
HIS REAL COMMITMENT, RIGHT?
AND SUPPORT FOR THE MOONSHOT.
ANY THOUGHTS?
>> YEAH, THANKS FOR THE
QUESTION.
I THINK, YOU KNOW, THE WHITE
HOUSE HAS BEEN VERY CLEAR THAT
THIS INITIATIVE IS BIGGER THAN
ANY ONE PERSON.
AND THERE ARE A TREMENDOUS
NUMBER OF TALENTED AND TERRIFIC
SCIENTISTS ACROSS GOVERNMENT,
OUTSIDE OF GOVERNMENT, THAT ARE
AVAILABLE TO HELP WITH THIS.
SO I THINK WE'LL BE FINE.
THIS-- WE'RE JUST AT THE
STARTING PHASE, AND I THINK
THERE ARE NO SHORTAGE OF GREAT
IDEAS IN THE WHITE HOUSE ON HOW
TO DEVELOP THE NEW MOONSHOT.
SO, IT IS OF COURSE -- WE'RE
SADDENED TO HEAR ABOUT THE
BEHAVIOR THAT LED TO DR.
LANDER'S RESIGNATION, NOT HOW
WE EXPECT TO DO BUSINESS IN THE
FEDERAL GOVERNMENT OR NCI.
WE'LL RECOVER WITHOUT MUCH OF A
HICCUP AND BE FINE.
>> I SEE THREE HANDS.
ELECTRA, ANDREA, AMY.
>> THANK YOU, JOHN.
THANK YOU, DR. SHARPLESS, FOR
THE TALK.
IT'S REFRESHING.
I'M ECSTATICS ABOUT THE SECOND
MOONSHOT AND THE FOCUS FROM THE
WHITE HOUSE, ALL YOU'RE DOING.
I WOULD LIKE TO ASK THAT THERE
BE INCLUSION OF ANOTHER PILLAR
IN YOUR PLAN.
AND YOU HAVE THE PATIENTS.
YOU ADDED NAVIGATORS.
REALLY THE COMMUNITY NEEDS TO BE
ANOTHER PILLAR, BECAUSE, YOU
KNOW, WE CAN PREVENT SIX CANCERS
WITH HPV VACCINE, UPTAKE AT BEST
50%.
WE CAN PREVENT COLON CANCER WITH
SCREENING.
OUR RATES ARE NOT WHERE THEY
NEED TO BE.
AND WE CAN ELIMINATE CERVICAL
CANCER, AS WE KNOW IT NOW.
AND WE'RE NOT.
AND WHY?
BECAUSE THAT ONE PILLAR IS
MISSING.
WE HAVEN'T TOLD PEOPLE HOW.
I LOVE -- I REALLY APPRECIATE
THE PRESIDENT SAYING GO GET
SCREENED AND, DOCTORS, SCREEN
YOUR PATIENTS.
IT'S NOT ENOUGH TO TELL PEOPLE
TO DO IT.
WE HAVE TO TELL THEM WHY AND
HAVE TO TELL THEM HOW.
AND PEOPLE LIKE ME, THAT'S WHAT
I DO IN MY RESEARCH.
I'VE DONE THAT FOR ALMOST 30
YEARS NOW.
AND IT'S NOT AN EASY THING.
IT'S NOT EASY.
AND WITHOUT CONSIDERATION OF
THAT, UNFORTUNATELY WE'RE NOT
GOING TO REACH THOSE TARGETS.
AND WE CAN REACH THOSE TARGETS
BECAUSE OF ALL THE FABULOUS
RESEARCH THAT'S ONGOING.
WE HAVE TO HAVE THAT CRITICAL
PIECE.
SO, I'M JUST ASKING IF YOU COULD
ADD A PILLAR TO YOUR PLAN AND
SOMEHOW BRING THAT TO THE
ATTENTION OF THE WHITE HOUSE
COMMITTEE, THAT THAT HAS TO BE
PART OF IT.
THANK YOU.
THANK YOU VERY MUCH.
>> SURE.
THANK YOU, ELECTRA.
WE SHARE YOUR ENTHUSIASM, I
THINK IT'S SPOT ON.
AND ASPIRATIONS IN THAT AREA.
AS YOU KNOW, NCI LOVES HPV
RESEARCH, HOW TO MAKE THAT A
REALITY.
THE PILLARS I SHOWED, I WANT TO
BE CLEAR, THAT'S NOT A FINAL
VERSION, RIGHT?
THIS IS A WORK IN PROGRESS.
THE WHITE HOUSE IS, AS I SAID,
STILL TALKING TO A LOT OF PEOPLE
BEYOND JUST THE NCI ON REALLY
WHAT THE PRIORITIES AND FOCUS
SHOULD BE.
I THINK SOME OF THIS PLATFORM
DEVELOPMENT IS GOING TO BE WORK
OF THE CANCER CABINET THAT I
ALLUDED TO.
I WILL VERY MUCH BRING THAT
CONCERN, VOICE OF THE COMMUNITY,
TO THESE DISCUSSIONS SO THANK
YOU FOR POINTING THAT OUT.
>> FANTASTIC.
THANKS, NED.
ANDREA?
>> YES, I WANTED TO SAY
SOMETHING SIMILAR ABOUT THE FACT
I WAS HAPPY TO SEE ACCESS
INCLUDED IN ONE OF THOSE
PILLARS, TO ADDRESS THE
DISPARITIES THAT WE HAVE IN
HEALTH CARE.
I COULDN'T HELP BUT THINK WHEN
YOU SHOWED THE RFI FOR THE BLOOD
BORNE DETECTION MCV WE NEED
SOMETHING SIMILAR FOR PROVIDERS
WITH IDEAS ABOUT HOW TO RESOLVE
THAT DISCONNECTION THAT ELECTRA
WAS TALKING ABOUT WITH THE
COMMUNITY.
IT'S JUST AS IMPORTANT TO HAVE
RFIS AND RFAs ON HOW DO WE
IMPROVE ACCESS TO ALL THESE
FABULOUS TREATMENTS THAT WE'RE
ABOUT TO DEVELOP AND WE FABULOUS
DISCOVERIES BUT IF WE CAN'T GET
TO EVERY SINGLE AMERICAN THEN
IT'S NOT GOING TO GET US TO OUR
GOAL OF REDUCING CANCER DEATHS.
SO I WOULD LIKE TO SEE US DO
MORE RFIS AND RFAs ON ACCESS
AND IMPROVE -- DECREASING
DISPARITIES BY INVOLVING THE
COMMUNITY MORE.
>> I THINK THE -- I'M CALLING
THIS IMPLEMENTATION SCIENCE
RESEARCH.
IF YOU HAVE SOMETHING DIFFERENT
IN MIND, CLARIFY.
I BELIEVE THIS IS AN IMPORTANT
TOPIC FOR CANCER RESEARCH AND I
AGREE WITH YOU.
IT DOESN'T DO VERY MANY MANY
GOOD IF WE HAVE GREAT THERAPIES
INTERESTED IN TERTIARY CARE
CENTERS AND NEVER DISSEMINATED
INTO THE COMMUNITIES TO CHANGE
OUTCOMES.
THE NCI IS A STRONG AND LIVELY
RESEARCH PORTFOLIO IN
IMPLEMENTATION SCIENCE, A FAIR
QUESTION TO ASK ARE THERE TOPICS
AND AREAS WE SHOULD FURTHER
ADDRESS AND WORK ON.
WE'VE HAD PRESENTATIONS AROUND
IMPLEMENTATION SCIENCE IN THE
PAST, CAN DO MORE IN THE FUTURE.
AND CERTAINLY HAVE PLANNED, HAVE
PLANNED AND CONTINUE TO PLAN
FUNDING OPPORTUNITIES IN THIS
AREA.
BUT I THINK AGAINST THAT
BACKDROP, NOW THERE'S A NEW
MOONSHOT.
AND SORT OF THE SAME POINT
ELECTRA WAS MAKING, NOT ONLY
GOING TO THE COMMUNITY BUT
RECEIVING FROM THE COMMUNITY, A
CRITICAL PART OF ANY SUCCESSFUL
ENDEAVOR.
>> THANKS, NED.
AMY?
>> LOVELY PRESENTATION.
HOW CAN WE GET OUR CANCER CENTER
DIRECTORS, THE VARIOUS PROGRAMS
IN THE NCI PORTFOLIO, TO REALLY
HELP ASSIST IN ADVOCATING FOR
LEGISLATION EXPANSION INTO THESE
ENDEAVORS?
DO YOU HAVE SOME SORT OF
SPECIFIC RECOMMENDATIONS THAT WE
COULD EXTEND OUT TO THESE FOLKS
TO HELP US HELP THE NCI?
>> AS A FEDERAL OFFICIAL, I WILL
NOT BE GIVING THE NCI DIRECTORS
HOW TO PASS LEGISLATION.
>> HOW ABOUT UNOFFICIAL ADVICE?
>> NO, NO, I CAN'T DO THAT.
YOU KNOW, I WILL TELL YOU,
CANCER CENTER DIRECTORS TALK TO
ME A LOT ABOUT AREAS WHERE THEY
THINK CHANGES TO POLICY OR LAW
CAN BE HELPFUL FOR CANCER
PATIENTS AND REALLY INTERESTING
ISSUES, LIKE, YOU KNOW, CARE
ACROSS STATE LINES WAS A BIG ONE
DURING THE PANDEMIC, FOR
EXAMPLE, OR COVERAGE FOR
SCREENINGS, TERRIFICALLY
IMPORTANT TOPICS AND I WILL ALSO
SAY I HAVE 100% CERTAINTY THAT
CONGRESS LISTENS TO THE CANCER
CENTER DIRECTORS.
THEY ARE A VERY POWERFUL VOICE.
PARTICULARLY IF THE CANCER
CENTER IS IN THE CONGRESSMAN'S
SPECIFIC DISTRICT, SUCCESSFUL TO
CONVEY WISHES TO CONGRESS BUT AS
NCI DIRECTOR I PROBABLY OUGHT TO
STAY OUT OF GIVING THEM ADVICE
ON WHAT, EVEN THOUGH I SHARE
MANY OF YOUR GOALS AND HOPES IN
THAT AREA.
>> WE HAVE JUST A COUPLE MORE
MINUTES.
IT WOULD BE GREAT IF YOU COULD
GIVE YOUR PERSPECTIVE SITTING IN
THE ROOM.
DID ANYTHING RESONATE IN TERMS
OF DISCIPLINES OR SPECIFIC AREAS
OF RESEARCH THAT YOU COULD SORT
OF -- THAT MIGHT HAVE BEEN
HIGHLIGHTED DURING THE
PRESIDENT'S COMMENTS?
>> YEAH, SURE.
I THOUGHT THE PARTS THAT I FOUND
PARTICULARLY COMPELLING --
FIRST, THE SPEAKERS WERE -- FOUR
SPEAKERS WERE TERRIFIC.
IT WAS A GREAT PROGRAM.
AS I SAID, IT WAS -- I TOLD
SEVERAL OF YOU IT REMINDED ME OF
A WEDDING, ALL THESE PEOPLE YOU
HADN'T SEEN IN A WHILE, ALL
TOGETHER IN REAL LIFE, EVERYBODY
IN A GOOD MOOD, A GREAT PAGEANT.
A LOVELY EVENT WITH TERRIFIC SPEAKERS.
I THOUGHT THE PRESIDENT -- THE
PRESIDENT SINGLED OUT THREE
THINGS IN THE FIRST
ANNOUNCEMENT.
THIS IS NOT THE LAST
ANNOUNCEMENT.
THINGS THE PRESIDENT DIDN'T SAY,
DON'T READ ANYTHING INTO IT YET,
BUT THE THINGS SORT OF NEW HERE,
PARTICULAR FOCUS, WERE THE
ANNOUNCEMENT FOR THIS GOAL OF
DECLINING CANCER MORTALITY, 50%
REDUCTION IS A BIG DEAL.
THE FOCUS AROUND PREVENTION,
SCREENING, EARLY DETECTION, EVEN
THE MENTION OF MULTI-CANCER
EARLY DETECTION TESTS IS MUSIC
TO THE NIH'S EARS BECAUSE THOSE
TRIALS ARE SUPER IMPORTANT,
RESEARCH IS INCREDIBLY INTRICATE
AND DIFFICULT AND EXPENSIVE.
THAT'S THE KIND OF AREA WHERE
SUPPORT WOULD BE APPRECIATED.
AND LASTLY WAS THE SORT OF
COMMITMENT TO MAKING UP MISSED
SCREENING, VERY MUCH TOP OF MIND
INTEREST IN THE WHITE HOUSE,
RECOVERING FROM THE PANDEMIC,
AND SO SORT OF RIGHTING THE SHIP
OF CANCER CARE, NOT JUST
SCREENING, LOTS OF ASPECTS, BUT
RUSHING TO NORMALCY IN TERMS OF
ELECTIVE SURGERIES, MISSED
DIAGNOSES IS A TOP PRIORITY.
THE FIRST LADY HAS BEEN SPEAKING
ABOUT THIS, THE PRESIDENT SHARES
THAT GOAL.
I THINK THOSE ARE THE SORT OF
FIRST COUPLE THINGS ALONG WITH
THE ANNOUNCEMENT OF THE CANCER
CABINET.
KAREN AND JOHN WERE THERE.
MAYBE A FEW OTHERS AS WELL.
IF OTHERS HAD THOUGHTS I DIDN'T
CAPTURE, KAREN AND JOHN, WHAT
WERE YOUR THOUGHTS?
>> NO, YOU CAPTURED IT.
GREAT JOB.
THE EARLY DETECTION PART WAS
JUST SO -- WAS FRONT AND CENTER.
SO SCREENING, EARLY DETECTION
WAS FANTASTIC.
THANKS, NED.
WE'RE RIGHT ON TIME.
RIGHT AT THE 45-MINUTE MARK.
SO WHY DON'T WE MOVE AHEAD.
IF YOU HAVE ANY ADDITIONAL
COMMENTS OR QUESTIONS FOR DR.
SHARPLESS, PLEASE PUT THEM IN
THE CHAT.
NEXT UP, WE'LL HAVE LEGISLATIVE
REPORT FROM M.K. HOLOHAN.
M.K.?
>> THANK YOU FOR THE OPPORTUNITY
TO SPEAK WITH YOU TODAY.
IN THE TIME WE HAVE TODAY I'M
GOING TO DO A BRIEF OVERVIEW.
THERE'S MORE DETAILS IN THE
LEGISLATIVE UPDATE MATERIALS,
AND IF YOU OR YOUR STAFF WOULD
LIKE MORE INFORMATION OR HAVE
QUESTIONS ABOUT THINGS YOU HEARD
ABOUT LEGISLATION GET IN TOUCH
WITH US.
MY TEAM AND I WOULD BE HAPPY TO
TALK WITH YOU AND YOUR STAFF.
NEXT SLIDE PLEASE.
SO I'M GOING TO DO A BRIEF
OVERVIEW IN THE TIME TODAY,
TALKING ABOUT FY 22
APPROPRIATIONS, GOOD NEWS
FINALLY, I'LL BE TELLING YOU
ABOUT WHAT WE KNOW SO FAR.
WE'RE NOT QUITE OUT OF THE WOODS
YET BUT REALLY BIG NEWS LAST
NIGHT.
LEGISLATION AND ISSUES TO WATCH,
TWO THINGS, I'LL TALK ABOUT
THREE NOW, CURES AND PREVENT
PANDEMIC, GOING INTO LATER, AT
THE END TALKING ABOUT
RETIREMENTS AND OUTLOOK FOR THE
MIDTERMS.
GIVING YOU BACKGROUND ON
TELEHEALTH, THIS IS OF
TREMENDOUS INTEREST TO A LOT OF
PEOPLE, IT'S BECOME A REAL ISSUE
IN THE HEALTH SPACE, IN
CONGRESS.
THERE'S OVER 50 BILLS INTRODUCED
IN THIS CONGRESS THAT TOUCH ON
TELEHEALTH.
THIS IS A PRIORITY FOR THE
ADMINISTRATION, HHS IS VERY
ENGAGED.
WE DETAIL ON THE UPDATE A FEW OF
THE SPECIFIC TELEHEALTH
PROVISIONS GRAPPLING WITH HOW TO
RETAIN FLEXIBILITIES THAT PEOPLE
LIKE, PATIENTS LIKE, PROVIDERS
LIKE, GRAPPLING WITH PAYMENT
ISSUES AND CONCERNS ABOUT FRAUD.
AND HOW IS THIS GOING TO FIT
INTO THE EXISTING SYSTEM.
THIS IS AN ISSUE WE'LL BE
TRACKING CLOSELY AND IT'S
PROBABLY -- IT WILL BE LATER
INTO THE YEAR, PROBABLY IN THE
FALL WHEN WE SEE LEGISLATION
MOVE BUT THIS IS A VERY ACTIVE
AREA.
ANOTHER AREA THAT CONGRESS HAS
BEGUN TO PAY SOME ATTENTION TO,
SOMEWHAT IT'S KIND OF
DOVETAILING WITH DR. ROBERT
CALIFF'S CONFIRMATION PROCESS,
NOMINATED TO FDA COMMISSIONER A
SECOND TIME.
CONGRESS HAS BEGUN TO PAY
ATTENTION TO ACCELERATED
APPROVAL PROGRAM, CONCERNS ABOUT
PHARMACEUTICAL COMPANIES
PROVIDING DATA AFTER ACCELERATED
APPROVAL.
SOME WAS SORT OF BEGUN WITH
CONGRESSIONAL CONCERNS ABOUT THE
ALZHEIMER'S DRUG, APPROVAL,
SENATOR WYDEN ASKED HIM TO
COMMIT TO TAKING ACTION IN 30
DAYS IF CONFIRMED THAT
PHARMACEUTICAL COMPANIES PROVIDE
DATA ACCORDING TO THE PROGRAM.
CONGRESS IS STARTING TO PAY
ATTENTION IN THE BIGGER CONTEXT,
WE'LL HEAR MORE ABOUT THAT SOON.
THE COMPETES ACT, SO THIS IS --
THERE'S A HOUSE AND SENATE
VERSION.
THIS BILL, THESE BILLS, HAVE HAD
SO MANY NAMES.
I THINK IT'S NOW GOING TO BE
CALLED THE MAKE IT IN AMERICA
ACT BUT WE'LL SEE IF THAT
STICKS.
THE SENATE HAD THE ENDLESS
FRONTIER ACT, IT THEN BECAME THE
UNITED STATES INNOVATION AND
COMPETITION ACT.
THE HOUSE JUST PASSED THE
COMPETES ACT.
THESE ARE -- THESE BILLS ARE
SIMILAR IN I HEARD IT DESCRIBED
YESTERDAY AS TENT POLES ARE THE
SAME BUT THERE'S A LOT OF
DIFFERENCES IN HOW MUCH FUNDING
NSF WOULD GET, WHERE FUNDING
WOULD GO SPECIFICALLY WITHIN
NSF, ABOUT R&D, SEMI CONDUCTOR,
SUPPOSED TO HELP WITH SUPPLY
CHAIN, A BIG PRIORITY FOR
SENATOR SCHUMER.
UNFORTUNATELY, IT'S 50-50
SENATE, TOUGH TO PASS ANYTHING
WITHOUT BIPARTISAN SUPPORT.
THAT WAS THE CASE BEFORE THE
NEWS AT THE BEGINNING OF THIS
MONTH.
THERE WAS SOME REALLY SAD NEWS
ABOUT SENATOR LUHAN OF NEW
MEXICO, 49-YEAR-OLD SENATOR HAD
A STROKE, SURGERY, RECUPERATING,
IN ADDITION TO CONCERN FOR THEIR
COLLEAGUE SENATE LEADERSHIP IS
NOW FACED WITH A REAL PROBLEM
THEY NEED THAT VOTE.
SO THIS IS GOING TO BE A SLOW
PROCESS OF GETTING THIS
COMPETITIVE LEGISLATION THROUGH.
SENATE PASSED THEIR BILL IN
JUNE.
HOUSE JUST PASSED THEIR BILL
LAST WEEK.
WE'LL BE WATCHING THAT CLOSELY.
I'M GOING TO TOUCH ON CURES 2.0,
ARPA-H, AND THEN PREVENT
PANDEMICS LEGISLATION THE SENATE
HEALTH COMMITTEE HAS BEEN
WORKING ON.
NEXT SLIDE PLEASE.
SO FY 22 APPROPRIATIONS, THESE
ARE THE NUMBERS.
THIS IS WHAT THINGS LOOK LIKE
RIGHT NOW.
THE C.R. THAT THE HOUSE PASSED
EARLIER THIS WEEK, TUESDAY
NIGHT, WILL TAKE US THROUGH
MARCH 11.
CURRENTLY WE'RE UNDER C.R. THAT
EXPIRES ON FEBRUARY 18.
SENATOR SCHUMER SAID EARLIER
TODAY THE SENATE WILL VOTE ON
THE C.R. NEXT WEEK.
HOPEFULLY THAT WILL BE SMOOTH
SAILING.
THERE WAS A BIT OF A -- SOME
REPORTING THIS MORNING ABOUT
SOME CONCERNS SENATOR BLACKBURN
FROM TENNESSEE RAISED ABOUT
SAMHSA PROGRAM, HARM REDUCTION
PROGRAM.
SENATOR SCHUMER SOUNDED
CONFIDENT ABOUT THE VOTE NEXT
WEEK.
AGAIN, IT'S A 50-50 SENATE SO HE
NEEDS BIPARTISAN SUPPORT TO GET
ANYTHING PASSED.
THESE ARE THE NUMBERS PROPOSED
IN THE PRESIDENT'S BUDGET.
IN THE HOUSE BILL THAT WAS
PASSED IN JULY, SENATE DID NOT
ACTUALLY PASS A BILL OUT OF
COMMITTEE.
MAJORITY RELEASED THEIR DRAFT
BILL.
THEY DIDN'T HAVE THE VOTES TO
GET THE BILLS THROUGH
SUBCOMMITTEE.
BUT THESE ARE THE NUMBERS WE'RE
LOOKING AT FOR NIH, FOR ARPA-H,
AND FOR NCI.
SO WE WILL BE WATCHING THIS
CLOSELY.
AND HOPEFULLY WE WILL HAVE A
C.R. THROUGH MARCH 11 BY SOME
TIME NEXT WEEK SO WE CANNOT GO
THROUGH THE PREPARATION FOR A
SHUTDOWN THAT'S SO OFTEN THE
CASE THAT HAPPENS WITH THESE
LONG -- WITH THE CRs THAT GO
RIGHT TO THE ELEVENTH HOUR.
NEXT SLIDE PLEASE.
WHEN I SAID WE'RE ALMOST OUT OF
THE WOODS I THINK A LOT OF THE
MOMENTUM IN GETTING TO THE NEWS
WE HEARD LAST NIGHT, THAT THE
SENATE AND HOUSE AGREED ON
PARITY, THEY CAME UP WITH AN
ACCEPTABLE SOLUTION, REPUBLICANS
WANTED THERE TO BE PARITY WITH
DEFENSE AND NON-DEFENSE
SPENDING.
THE PRESIDENT'S BUDGET DID NOT
PROPOSE A LARGE INCREASE, IT WAS
2% INCREASE FOR DEFENSE, THE
HOUSE WENT A LITTLE HIGHER,
SENATE WENT HIGHER THAN THAT.
IT'S AN ISSUE.
AND THAT WAS A DEAL-BREAKING
ISSUE WITH POLICY WRITERS THAT
DEMOCRATS PUT INTO THE HOUSE
BILL.
IT REALLY -- THERE WASN'T A LOT
OF PROGRESS FOR MONTHS.
THAT WAS REALLY BECAUSE CONGRESS
WAS VERY OCCUPIED WORKING ON THE
INFRASTRUCTURE BILL THAT WAS
PASSED AND SIGNED INTO LAW.
AND THE BUILD BACK BETTER SOCIAL
INFRASTRUCTURE LEGISLATION THAT
AS I THINK EVERYONE KNOWS HAS
BEEN SORT OF PUT ON HOLD FOR A
BIT.
THEY MAY NEED TO HAVE ANOTHER GO
AT THAT AND REWORK IT INTO A
PACKAGE THAT IS -- THEY ARE
GOING TO BE ABLE TO GET THE
VOTES TO PASS.
BUT APPROPRIATIONS, THE WHOLE
SPENDING PROCESS WAS SORT OF
COLLATERAL DAMAGE TO JUST THERE
WAS NOT THE ATTENTION AND ENERGY
ABLE TO BE PUT FORWARD TOWARDS
APPROPRIATIONS THEN BECAUSE
THESE WERE SUCH LARGE ISSUES, A
BIG PRIORITY FOR CONGRESS.
TWO RETIRING SENATE, CHAIR OF
THE SENATE FULL APPROPRIATIONS
COMMITTEE AND RANKING MEMBER,
PATRICK LEAHY FROM VERMONT,
RICHARD SHELBY FROM ALABAMA,
WORKED TOGETHER FOR 36 YEARS.
AND KNOW HOW TO MAKE A DEAL.
THEY HAVE PUT A LOT OF ENERGY
INTO THIS.
I THINK THAT WE'VE BEEN
OPTIMISTIC THAT THEY WOULD WANT
TO GET THIS DONE IN THEIR FINAL
CONGRESS, AND THERE ARE EARMARKS
IN THESE SPENDING BILLS FOR THE
FIRST TIME IN OVER TEN YEARS.
SO THERE'S A LOT OF INCENTIVE TO
WANT TO GET THESE BILLS DONE SO
I THINK WE CAN BE CAUTIOUSLY
OPTIMISTIC AT THIS POINT.
NEXT SLIDE PLEASE.
SO CURES 2.0, DIANA DEGETTE OF
COLORADO AND FRED UPTON OF
MICHIGAN INTRODUCED H.R. 6,000
IN NOVEMBER OF 2021.
IT COVERS WIDE RANGE OF ISSUES
INCLUDING TELEHEALTH, IT WOULD
ESTABLISH ARPA-H WITHIN THE NIH.
THERE'S OTHER LEGISLATION
INTRODUCED BY CONGRESSWOMAN ANNA
ESHU, IN THE HOUSE, HER BILL
WOULD ESTABLISH ARPA-H WITHIN
HHS.
AND SO THERE'S PROBABLY PEOPLE
ARE -- IT'S FAIRLY COMMON
KNOWLEDGE THERE'S A SPLIT OF
OPINION WHERE ARPA-H SHOULD BE
WITHIN NIH OR OUTSIDE OF NIH.
IT IS PROPOSED IN THE
PRESIDENT'S BUDGET AS WITHIN
NIH.
WE'LL SEE WHAT HAPPENS.
NEXT SLIDE PLEASE.
THERE WAS A HEARING IN THE
ENERGY AND COMMERCE COMMITTEE
THIS WEEK, ON TUESDAY, BOTH
DIANA DEGETTE AND FRED UPTON ARE
ON THAT COMMITTEE.
THEY CAME AND SPOKE ABOUT
WORKING WITH CONGRESSWOMAN ESHU
ABOUT HER LEGISLATION, THERE
SEEM TO BE POSITIVE STATEMENTS
FROM ALL THREE MEMBERS WILL
COMPLEMENTARY LEGISLATION, THEY
MAY HAVE COME UP WITH
COMPROMISES.
WE DON'T KNOW WHAT THE SENATE
WILL DO WHEN THEY TAKE UP
LEGISLATION.
THE HEARING WAS INTERESTING.
NOT ALL THE WITNESSES SPOKE
ABOUT -- VOICED AN OPINION WHERE
ARPA-H SHOULD BE FOR MAXIMUM
EFFECTIVENESS, THOSE THAT DID
RULED OF FAVORED INDEPENDENT,
THE SECRETARY CAN DECIDE HOW THE
AGENCY WOULD OPERATE.
WE'LL BE WATCHING AND SEEING
WHAT HAPPENS WITH THIS
LEGISLATION IN THE HOUSE.
BECAUSE THERE IS THIS YEAR MUST
PASS LEGISLATION, FDA USER FEE
LEGISLATION HAS TO BE
REAUTHORIZED.
PEOPLE SAY PDUFA, THAT'S WHAT
THEY MEAN, I'M NOT GOING TO READ
THROUGH THE TITLE OF THE BILL
NOW.
IT BECOMES A TARGET OF THINGS
YOU CAN ATTACH OTHER PIECES OF
LEGISLATION TO, SO WHEN YOU KNOW
SOMETHING IS GOING TO BE MOVING,
ESPECIALLY A LARGE PIECE OF
LEGISLATION LIKE THAT, THERE'S
AN OPPORTUNITY FOR OTHER THINGS
TO MOVE AT THAT TIME TOO.
AND AS WE START TO GET CLOSER TO
THE MIDTERM ELECTIONS AND
DEADLINE TO GET THAT LEGISLATION
DONE, I THINK THAT'S WHEN WE'LL
START TO SEE THE CURES 2.0 AND
OTHER LEGISLATION.
THE SENATE HEALTH COMMITTEE,
HEALTH EDUCATION LABOR AND
PENSIONS COMMUNITY, CHAIRED BY
SENATOR PATTY MURRAY OF
WASHINGTON STATE AND RANKING
MEMBER IS RICHARD BURR OF NORTH
CAROLINA, THEY HAVE SPENT A LOT
OF 250EU78 DEVELOPING THIS --
TIME DEVELOPING PREVENT
PANDEMICS ACT, BOTH COMMITTED TO
TRYING TO FIGURE OUT WHAT WENT
WRONG, IN TERMS OF BEING
PREPARED FOR A PANDEMIC LIKE
COVID AND WHAT WE CAN DO BETTER
IN THE NEXT -- TO BE BETTER
PREPARED FOR A FUTURE SITUATION
LIKE THIS.
THERE'S A LOT OF CDC PROVISIONS
IN THE BILL.
ONE DETAIL IT WOULD REQUIRE CDC
DIRECTOR TO GO THROUGH SENATE
CONFIRMATION AS FDA COMMISSIONER
HAS TO.
AS THE SECRETARY OF HHS DOES.
THERE'S ALSO TEXT ABOUT
COLLABORATIONS WITH NIH AND CDC
AND STRATEGIC PLANNING FOR CDC,
BUT WE'LL SEE HOW THAT BILL
DEVELOPS OVER TIME AND WHAT SORT
OF INPUT THEY GET.
THEY ARE ACCEPTING COMMENTS NOW.
AND THAT'S WHAT THEY ARE LOOKING
FOR.
WE'LL START TO SEE THAT MOVE
TOWARDS LATER IN THE YEAR.
NEXT SLIDE PLEASE.
SO THERE ARE A LOT OF
RETIREMENTS.
THE HOUSE PRESS GALLERY HAS THIS
WEBSITE THEY KEEP UPDATED,
CASUALTY LIST, I MENTIONED
SENATOR LEAHY AND SENATOR SHELBY
RETIREMENTS, WE'RE ALSO SEEING
SENATOR BURR AND SENATOR ROY
BLUNT, WHO HAS BEEN THE TOP
REPUBLICAN ON THE APPROPRIATIONS
SUBCOMMITTEE, LABOR HHS
APPROPRIATIONS SUBCOMMITTEE FOR
NIH.
AND SO THERE'S A LOT OF
EXPERTISE THAT'S GOING TO BE
LEAVING THE SENATE IN THESE
COMMITTEES.
FOR THE SENATE THERE'S ONLY ONE
DEMOCRAT, SENATOR LEAHY,
ANNOUNCED RETIREMENT.
FOR THE G.O.P. IT'S FIVE
REPUBLICANS ANNOUNCED
RETIREMENTS.
IN THE HOUSE FAR TOO MANY NAMES
AND PICTURES TO SHOW HERE.
I SELECTED A FEW MEMBERS FROM
EACH PARTY WHO HAVE BEEN
PARTICULARLY ENGAGED WITH NCI
AND NIH OR HAVE LEADERSHIP
POSITIONS, JACKIE SPEIR HAS BEEN
AN ADVOCATE, AS G K BUTTERFIELD,
REPRESENTATIVE DAVID PRICE FROM
NORTH CAROLINA, AND
REPRESENTATIVE LUCILLE
ROYBAL-ALLARD, KEVIN BRADY
CHAIRMAN OF WAYS AND MEANS, A
COMPETITION TO GET THAT JOB
AFTER HE RETIRES, AND EVERYONE
KNOW WHO IS ADAM KINZINGER IS,
HE'S BEEN IN THE NEWS THE LAST
YEAR OR TWO, STEPPING DOWN FROM
HIS POSITION.
SO WE'RE GOING TO SEE A LOT OF
NEW NAMES AND NEW FACES, AND
PEOPLE IN LEADERSHIP POSITIONS.
IT'S NOT JUST THESE MEMBERS
REPRESENT IMPORTANT INTERESTS
AND HAVE DONE A LOT OF GREAT
WORK.
THEY HAVE ALSO GOT LEADERSHIP
POSITIONS, WE'LL SEE IN THE NEXT
CONGRESS RACES TO TAKE THOSE
GAVELS.
NEXT SLIDE PLEASE.
SO THERE'S A LOT OF TIME BETWEEN
NOW AND THE MIDTERMS, AND WE'LL
HAVE MORE MEETINGS TO TALK
ABOUT, WHAT THINGS LOOK LIKE.
I WANT TO REMIND EVERYONE WHAT
HISTORY TELLS US.
THIS IS BY NO MEANS A GUARANTEE,
BUT THE PRESIDENT'S PARTY WITH
TWO EXCEPTIONS IN THE PAST 50
YEARS LOSES SEATS IN THE
MIDTERMS.
AND THIS IS WHAT SOME OF THE
NATIONAL JOURNAL ASSESSMENT OF
WHAT NUMBERS HAVE LOOKED LIKE IN
THE HOUSE AND SENATE SINCE 1946.
NEXT SLIDE PLEASE.
AND THEN HERE'S ANOTHER SLIDE
WHERE THEY TOOK A DIFFERENT
LOOK, LOOKING AT EACH
PRESIDENCY, WHAT HAPPENS IN THE
MIDTERMS DURING EACH OF THESE
PRESIDENCIES.
I THOUGHT IT WOULD BE
INTERESTING TO LOOK AT SOME
DATA.
THAT'S ALL I HAVE FOR TODAY.
IF YOU HAVE ANY QUESTIONS I'M
HAPPY TO TAKE THEM NOW, IF DR.
CARPTEN SAYS WE CAN DO THAT OR
GET IN TOUCH WITH ME AND WE CAN
TALK AT YOUR CONVENIENCE.
>> THANKS, M.K.
WE DO HAVE FIVE MINUTES FOR
QUESTIONS.
ANY QUESTIONS?
SO FROM MY PERSPECTIVE, IT WAS
INTERESTING TO SEE FROM, YOU
KNOW, THE PROPOSED BUDGETS TO
SORT OF -- WHAT CURRENTLY COULD
BE PLANNED, DECREASE IN OVERALL
NIH, BUT LOOKS LIKE NCI WOULD DO
PRETTY WELL.
HOW WOULD THE DECREASE IN THE
OVERALL NIH BUDGET IMPACT NCI?
WOULD IT IMPACT NCI AT ALL?
I DON'T KNOW IF NED WANTS TO
CHIME IN.
>> THERE WASN'T -- SO SOME OF
THE INCREASES PROPOSED WERE NOT
LARGE.
THERE WHY NO BUDGET -- THE
PRESIDENT'S BUDGET, SENATE AND
HOUSE ALL WOULD INCREASE THE NIH
BUDGET.
BUT THERE WERE VERY DIFFERENT
NUMBERS FOR WHAT ARPA-H WOULD BE
FUNDED AT AND DIFFERENT NUMBERS
FOR NCI.
FOR US, THE HOUSE NUMBER WAS
INCREASE OF $434 MILLION.
SENATE NUMBER I WANT TO SAY 212.
YEAH, 212.
SO, YEAH, THAT'S A BIG
DIFFERENCE.
I DON'T KNOW IF NED WANTS TO
COMMENT ON THAT, BUT OBVIOUSLY
THAT'S EXACTLY WHAT WE WERE
REALLY WORRIED ABOUT WITH THE
FULL YEAR C.R., AND WE'RE
ALREADY OVER FOUR MONTHS INTO
THE C.R.
YOU KNOW, IT'S LIKE A CUT IN AN
APPROPRIATION.
I DON'T KNOW, NED, IF YOU WANTED
TO COMMENT ON THAT.
>> THERE'S SORT OF THREE
VERSIONS.
THERE'S THE FULL YEAR C.R., A
DISASTER.
THERE'S THE $200 MILLION
INCREASE, AND $400 MILLION FOR
THE HOUSE.
$200 MILLION IS A BIG
DIFFERENCE.
BY THE WAY, CONGRESS COULD DO
SOMETHING DIFFERENT FROM ALL
THREE OF THOSE.
NONE OF THOSE THINGS ARE
BINDING.
SO WE WILL HAVE TO WAIT AND SEE
WHAT HAPPENS.
AS M.K. SAID, IT'S GREAT NEWS
THAT THEY ARE FINALLY AT LEAST
AGREES ON TOP LINE NUMBERS, THE
FIRST THING THAT HAS TO HAPPEN.
>> YEAH, CHRIS?
I SEE YOUR HAND UP.
>> THANKS, JOHN.
M.K., THANKS FOR ALL YOUR TEAM
DOES IN THIS CHALLENGING TIME.
ARPA-H, MY UNDERSTANDING IS
THERE'S NOT SENATE -- OR OPEN
DISCUSSION YET, IS THAT CORRECT?
I HAVEN'T SEEN ANYTHING IN THE
SENATE IN TERMS OF PEOPLE
WEIGHING IN ON HHS VERSUS NIH
LOCATION AND THINGS LIKE THAT.
>> RIGHT.
YEAH, THERE'S -- WE HAVEN'T SEEN
LEGISLATION INTRODUCED.
WE MAY NOT.
IT MAY BE PART OF A CURES
NEGOTIATION.
WE'VE SEEN SOME -- POLITICAL
REPORTERS WILL ASK MEMBERS AS
SOON AS THE PRESIDENT'S BUDGET
COMES OUT, AND THEY SORT OF MAKE
THE PITCH.
AND, YOU KNOW, ARPA-H I'M SURE
THERE WILL BE QUESTIONS ABOUT
IT, AT A VARIETY OF
APPROPRIATIONS HEARINGSING FORS
FY23, WHICH I THINK WE EXPECT TO
BE HAPPENING LATE MARCH INTO
APRIL.
STATE OF THE UNION IS -- IT WILL
BE AFTER THAT THE PRESIDENT'S
BUDGET IS RELEASED SO SOMETIME
IN MARCH.
SO, YEAH, WE'LL SEE.
I THINK THE SENATE IS SORT OF --
HAS NOT ENTERED INTO THE
SPECIFIC DISCUSSIONS ABOUT WHEN
AND WHERE THERE'S BEEN SOME
BRIEFINGS THAT ARE, YOU KNOW,
HIGH LEVEL BRIEFINGS WE'VE HEARD
ABOUT.
I THINK THERE WILL BE INTEREST
IN SUPPORTING SOMETHING THE
PRESIDENT IS PROPOSING THAT'S AN
IMPORTANT PART OF HIS FY23
BUDGET AND SO WE'LL SEE WHERE IT
GOES.
I IMAGINE THERE WAS HOPE WE
WOULD BE FURTHER ALONG BY THIS
POINT IN TIME.
BUT THAT IS ALSO PROBABLY A
FACTOR OF JUST APPROPRIATIONS
BEING SO DELAYED THIS YEAR.
>> THANK YOU.
>> WELL, THANKS, M.K.
IT'S GREAT.
I'M SURE ALL OF US WILL KEEP
EYES AND EARS OPEN AND HOPEFULLY
SEE MOVING TOWARDS AN ACTUAL
BUDGET IN THE NOT TOO DISTANT
FUTURE.
WE'RE A MINUTE AHEAD, WHICH IS
GOOD.
NEXT UP IS THE ANNUAL DELEGATION
ALSO OF AUTHORITY BY DR. GRAY.
PAULETTE?
>> THANKS, JOHN.
I'LL MAKE THIS AS UNBORING,
NON-BORING AS POSSIBLE.
OKAY?
BUT DELEGATIONS OF AUTHORITY
ALLOWS THE NCI TO FUNCTION IN
CERTAIN WAYS WITHOUT COMING TO
THE BOARD FOR EACH ISSUE.
SPECIFICALLY, THERE ARE TWO
DELEGATIONS, AND THESE
DELEGATIONS ARE TO NCI DIRECTOR.
AND THE FIRST DELEGATION ALLOWS
THE NCI DIRECTOR TO OBTAIN
PERMISSION IN ACCORDANCE WITH
SECTION 413B OF THE PUBLIC
HEALTH SERVICE ACT AND SECTION
3109 UNITED STATES TITLE CODE TO
OBTAIN THE SERVICES OF NOT MORE
THAN 151 SPECIAL EXPERTS OR
CONSULT I ANTS WHO HAVE
QUALIFICATIONS TO ASSIST IN
ACCOMPLISHING THE MISSION OF THE
INSTITUTE.
DON'T ASK ME WHERE THE NUMBER
151 CAME FROM.
I'VE LOOKED.
I'VE NOT BEEN ABLE TO ASCERTAIN
HOW THEY CAME UP WITH THE NUMBER
151.
NOR ARE WE COUNTING.
SO DELEGATION B PROVIDES THE NCI
DIRECTOR THE PERMISSION TO
EXERCISE AUTHORITY AS STATED IN
SECTION 413B OF THE PUBLIC
SERVICE HEALTH ACT TO APPOINT
ONE OR MORE ADVISORY COMMITTEES,
COMPOSED OF SUCH PRIVATE
CITIZENS AND OFFICIALS OF
FEDERAL, STATE, AND LOCAL
GOVERNMENTS TO ADVISE HIM WITH
RESPECT TO THE DIRECTOR'S
FUNCTIONS.
I'M GOING TO SHIFT TO STATEMENTS
OF UNDERSTANDING THAT THE BOARD
WILL HAVE WITH THE NATIONAL
CANCER INSTITUTE STAFF.
SPECIFICALLY, AND THIS IS IN
ACCORDANCE WITH NIH'S MANUAL
ISSUANCE 4513, RECOMMENDATION OF
INITIAL REVIEW GROUPS WILL BE
REQUIRED WITH EXCEPTION OF
TRAINING GRANTS, FELLOWSHIPS,
OTHER NON-RESEARCH GRANT
APPLICATIONS AND NOT PROPOSALS
TO CONDUCT OR SUPPORT RESEARCH.
THESE GRANTS, FELLOWSHIPS, ET
CETERA, ARE NOT SUBJECT TO NCAB
REVIEW AND APPROVAL WITHOUT
OTHER CONCERNS.
IF THERE ARE CONCERNS, THOSE
GRANTS WILL NOT BE AWARDED
UNLESS THEY ARE ACTUALLY BROUGHT
TO THE ATTENTION OF THE NCAB.
SPECIFICALLY RUTH KIRSCHSTEIN
SERVICE AWARDS, THOSE MUST COME
TO THE NCAB FOR YOUR
CONSIDERATION.
APPLICATIONS OVER THE 20th
PERCENTILE WILL NOT HAVE SUMMARY
STATEMENTS PRESENTED TO THE NCAB
UNLESS THE INSTITUTE IS
CONSIDERING THE AWARD OF SUCH AN
APPLICATION.
SPECIAL CONSIDERATION BY AN
APPOINTED NUMBER OF THE BOARD
WILL BE TAKEN INTO CONSIDERATION
AND FOR APPLICATIONS ASSIGNED
RAW SCORES THAT ARE NOT
PERCENTILE, THE CUTOFF WILL BE
AN IMPACT SCORE OF FIFTY, EXCEPT
FOR R 41, 42s, 43s, AND R 44
AWARDS.
ALL SCORED APPLICATIONS WILL BE
INCLUDED AND I'M SWITCHING NOW
TO EXPEDITED CONCURRENCE.
FOR R01 AN R21 APPLICATIONS,
EXCLUDING THOSE FROM FOREIGN
ORGANIZATIONS, WITH PERCENTILE
SCORES THAT FALL IN THE NCI PAY
LINES FOR THAT MECHANISM, THAT
HAVE NO CONCERNS NOTED THAT
WOULD REPRESENT, FOR EXAMPLE
HUMAN SUBJECTS, ANIMAL WELFARE,
HAZARDS, INCLUSION OF WOMEN,
CHILDREN, APPROPRIATE MINORITY
DISTRIBUTION.
THE REVIEWERS WILL CONSIST OF
THE CHAIR OF THE SUBCOMMITTEE ON
SPECIAL ACTIONS WHICH IS
FRANCIS, AND TWO ADDITIONAL NCAB
MEMBERS WILL BE APPOINTED TO
THAT SUBCOMMITTEE TO EXPEDITE
THESE GRANTS.
IN OTHER WORDS, IF THOSE R01
GRANTS THAT FALL WITHIN A
CERTAIN PERCENTILE BASED ON NCI
PAY LINE, THOSE WILL NOT COME TO
THIS BOARD, THEY WILL
AUTOMATICALLY BE INCLUDED IN THE
EN BLOC.
OKAY?
IN CASES OF EMERGING NEED AS
DETERMINED BY THE DIRECTOR OF
NCI, EXPEDITED CONCURRENCE MAY
BE UTILIZED FOR SINGLE CASE
DEVIATIONS.
THOSE SINGLE CASE DEVIATIONS
WILL BE REPORTED TO THE BOARD IF
THAT OCCURS.
ELECTRONIC CONCURRENCE MINIMUM
OF TWO NUMBERS WITH NO VOTES FOR
NON-CONCURRENCE MUST OCCUR
WITHIN SEVEN DAYS OF
NOTIFICATION OF POSTING IS
REQUIRED FOR APPROVAL AND THOSE
POSTINGS GIVEN TO THIS
SUBCOMMITTEE VIA ELECTRONIC
COUNCIL BOOK, NOT SOMETHING
THAT'S DONE VIA E-MAIL.
A SINGLE VOTE FOR
NON-CONCURRENCE IN ALLOTTED TIME
PERIOD WILL RESULT IN THAT
APPLICATION GOING FOR REGULAR
CONSIDERATION TO THE BOARD UNDER
ITS STANDARD PROCEDURE BUT
NON-EXPEDITED APPLICATION.
LACKING VOTES WILL BE PRESENTED
TO THE FULL NCAB AT REGULAR
MEETING.
NOW MOVING TO ADMINISTRATIVE
ADJUSTMENTS, MOST IMPORTANT TO
NCI.
THAT IS IN TERMS OF ENSURING
EFFICIENCY.
NCAB DELEGATES TO THE DIRECTOR
OF THE NATIONAL CANCER INSTITUTE
PERMISSION TO ALLOW STAFF TO
NEGOTIATE APPROPRIATE
ADJUSTMENTS IN DOLLARS, OTHER
TERMS, AND CONDITIONS OF GRANT
AND CORPORATE AGREEMENT AWARDS
RECOMMENDED BY THE BOARD.
IN DOING SO, THIS MAINTAINS THE
EFFECTIVE AND SMOOTH OPERATION
OF GRANTS BY THE INSTITUTES.
STAFF WILL ALSO BE ABLE TO
NEGOTIATE APPROPRIATE ADJUSTMENT
WHEN APPLICABLE.
STAFF WILL ALSO MAKE ADJUSTMENTS
TO RECONCILE INCONSISTENCIES
BETWEEN RECOMMENDED BUDGET AND
RECOMMENDED AIMS AND ACTIVITIES.
REQUEST FOR INCREASE IN DIRECT
COSTS, SIGNIFICANT CHANGE IN
SCIENTIFIC CONTENT AFTER FORMAL
PEER REVIEW WILL BE REFERRED TO
THE BOARD FOR ADVICE AND
RECOMMENDATION.
ACTIONS SUCH AS CHANGE OF
INSTITUTION, CHANGE OF PRINCIPAL
INVESTIGATOR, PHASE OUT OF
INTERIM OR ADDITIONAL SUPPORT TO
MEET INCREASED COST OF
MAINTAINING LEVEL OF RESEARCH
PREVIOUSLY RECOMMENDED OR TO
ACCOMMODATE ACTIVITIES JUDGED BY
STAFF TO BE WITHIN THE SCOPE OF
THE PREVIOUSLY PEER REVIEWED
RESEARCH NEED NOT BE REPORTED TO
THE BOARD.
THE DIRECTOR IN ADDITION STAFF
MAY RESTORE REQUEST FOR TIME AND
SUPPORT WHICH WERE DELETED BY
THE INITIAL REVIEW GROUP WHEN
THE PRINCIPAL 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.
ADDITIONALLY, DIRECTOR OF NCI
AFTER CONSULTATION WITH NCAB
CHAIR MAY MAKE EXCEPTIONS TO
THESE GUIDELINES.
FINALLY, THERE IS THE SPECIAL
COUNCIL REVIEW OF PRINCIPAL
INVESTIGATORS WITH GREATER THAN
ONE MILLION DIRECT COST IN RPG
AWARDS.
AND NIH INSTITUTED THIS POLICY
IN AN EFFORT TO CONTINUE
RESPONSIBLE STEWARDSHIP OF
PUBLIC FUNDS AND SUPPORT
MERITORIOUS AND INNOVATEIVE
RESEARCH.
NOW, I SHOULD SAY THAT THIS ONE
MILLION DIRECT COST WILL NO
LONGER EXIST FOLLOWING THIS
MEETING.
BEGINNING IMMEDIATELY FOLLOWING
THIS MEETING, THE DOLLAR LEVEL
WILL BE TWO MILLION TOTAL COST,
THAT THE BOARD WILL CONSIDER IN
REVIEWING SPECIAL COUNCIL REVIEW
APPLICATIONS.
THIS IS A THRESHOLD ONLY TODAY
AND IT WILL BE A THRESHOLD GOING
FORWARD.
INVESTIGATORS WHO HAVE MORE
RESEARCH SUPPORT MAY STILL
RECEIVE ADDITIONAL AWARDS AS
WARRANTED.
THE REVISED CONSIDERATION AS
I'VE INDICATED WILL OCCUR WHEN
THE GRANTS ARE CONSIDERED AT THE
JUNE NCAB MEETING DURING CLOSED
SESSIONS.
BUT TODAY IT'S STILL ONE MILLION
DIRECT COST.
OKAY?
OKAY.
ARE THERE QUESTIONS?
IF NOT, JOHN WILL CALL FOR A
VOTE.
>> WE NEED TO CALL A VOTE TO
CONFIRM DELEGATIONS OF
AUTHORITY.
DO WE HAVE A MOTION?
>> SO MOVED.
>> SECOND?
>> SECOND.
>> DISCUSSION?
PLEASE VOTE YAY OR NAY.
NO ABSTENTIONS.
>> I SAW TWO HANDS GO UP.
>> SO LET ME SEE ALL NAYS.
YAYS.
ANY NAYS?
ANYONE NEED TO ABSTAIN?
YAYS HAVE IT.
>> THANKS, JOHN.
>> THANK YOU, PAULETTE.
NEXT IS THE TRIENNIAL GENDER AND
MINORITY IN CLINICAL TRIALS
INCLUSION REPORT PROVIDED BY DR.
MARGARET MOONEY, ASSOCIATE
DIRECTOR OF THE CANCER TREATMENT
EVALUATION PROGRAM, CTEP.
MEG?
>> THANK YOU VERY MUCH.
I'M HAPPY TO PRESENT THE
TRIENNIAL RECORD FOR FISCAL
YEARS 2019-2020.
NEXT SLIDE PLEASE.
NIH IS MANDATED TO INCLUDE WOMEN
AND MINORITY GROUPS IN NIH
FUNDED RESEARCH, THE GOAL OF THE
LAW INSTITUTED IN THE 1970s IS
TO ENSURE RESEARCH FINDINGS CAN
BE MADE GENERALIZABLE TO THE
ENTIRE PATIENT POPULATION.
THE NIH REVITALIZATION ACT,
AMENDED BY THE 21ST CENTURY
CURES, ALSO REQUIRES ADVISORY
BOARD OF EACH NIH INSTITUTE TO
PREPARE TRIENNIAL REPORT
DESCRIBING THE MANNER THE NIH
COMPLIED FOR INCLUSION
REPORTING.
THE PRESENTATION TODAY WILL
EXPAND ON THE DATA SUBMITTED TO
THE NCAB.
NEXT SLIDE PLEASE.
THE SOURCE OF DATA INCLUDED
INCLUSION DATA IS QUITE BROAD.
IT INCLUDES CLINICAL RESEARCH
PATIENT ORIENTED, THIS MEANS AN
INVESTIGATOR DIRECTLY INTERACTS
WITH HUMAN SUBJECTS FOR THE
RESEARCH.
THIS INCLUDES LARGE EPIDEMIOLOGY
AND BEHAVIORAL STUDIES AS WELL
AS OUTCOMES RESEARCH AND HEALTH
SERVICES RESEARCH.
GRANTEES MUST REPORT INFORMATION
BE A WAIL -- ANNUALLY, AND ANY
CLINICAL RESEARCH SUPPORTED BY
GRANTS OR INTRAMURAL NCI PROGRAM
IS ALSO REPORTED ANNUALLY.
NEXT SLIDE.
WE'VE LISTED HERE ALL THE NCI
DIVISIONS, OFFICES, CENTERS,
WHICH REPORT ON CLINICAL
RESEARCH ON INCLUSION REPORTING
FOR THE NCI.
RESEARCH DIFFERS BY DIFFERENT
PROGRAMS BUT WE'RE ALL REQUIRED
TO REPORT.
NEXT SLIDE.
THERE ARE SEVERAL STRATEGIES FOR
ENSURING COMPLIANCE, FIRST
STARTS WITH PEER REVIEW,
REVIEWERS EVALUATE APPLICATIONS
FOR THE APPROPRIATENESS OF
CONCLUSION PLANS AND ANALYSES,
THAT'S FOLLOWED BY PROGRAM
MONITORING AND GRANTS MANAGEMENT
OVERSIGHT, ONCE AN AWARD IS
MADE.
ON THE INTRAMURAL SIDE,
INTRAMURAL INVESTIGATORS PROVIDE
INCLUSION PLANS DURING THEIR
SCIENTIFIC REVIEW.
AND ENROLLMENT PROGRESS, AS PART
OF ANNUAL SCIENTIFIC AND IRB
REVIEW.
LAST BUT NOT LEAST, TRAINING IS
PROVIDED ON A REGULAR BASIS FOR
ALL PROGRAM AND REVIEW STAFF.
NEXT SLIDE PLEASE.
SO BEFORE WE PRESENT SOME OF THE
DATA FROM THE TRIENNIAL REPORT,
WE DID WANT TO POINT OUT THERE
ARE SOME KEY LIMITATIONS TO THE
DATA THAT YOU WILL SEE.
FIRST OF ALL, YOU'LL SEE REPORTS
NUMBERING INCLUSION DATA
RECORDS.
WE DID WANT TO POINT OUT THESE
DO NOT REPRESENT A TOTAL COUNT
OF THE NUMBER OF STUDIES OR
TRIALS DONE BECAUSE MULTIPLE
RECORDS MAY BE SUBMITTED FOR
SINGLE TRIAL.
IT DOES GIVE YOU THE VOLUME OF
REPORTING DONE ACROSS THE
PROGRAM BY GRANTEES,
CONTRACTORS, INTRAMURAL PROGRAM,
BUT DOES NOT REPRESENT EXACT
NUMBER OF STUDIES.
SECONDLY IT'S IMPORTANT TO
REMEMBER THAT THE INCLUSION DATA
DO NOT REPRESENT THE ENROLLMENT
OR RECORDS FOR A PARTICULAR
YEAR.
INSTEAD, THE ENROLLMENT DATA IS
REALLY CUMULATIVE, FOR A
PARTICULAR CLINICAL RESEARCH
STUDY DURING THE PROJECT PERIOD
AS LONG AS IT WAS ACTIVE IN THAT
FISCAL YEAR.
THIRDLY, GRANTS THAT ARE
COMPETED IN A FISCAL YEAR ARE
NOT INCLUDED IN THE DATA FOR
THAT YEAR.
SO THIS IS OF PARTICULAR
IMPORTANCE THIS TRIENNIAL REPORT
BECAUSE TWO OF OUR LARGEST
NATIONAL CLINICAL TRIALS
NETWORKS IN THE EXTRAMURAL
COMMUNITY, NATIONAL CLINICAL
TRIALS NETWORK AND NCCOR WILL
RECOMPETE IN 2019, ENROLLMENT IN
FISCAL YEAR 2019 ON CLINICAL
TRIALS THAT SPECIAL REPORT AS
WELL AS CLINICAL RESEARCH IS
LOWER BECAUSE THOSE TWO LARGE
NETWORKS WERE RECOMPETED IN
FISCAL YEAR 2019 AND SO THEIR
ENROLLMENT DATA IS NOT INCLUDED.
THERE WAS A ONE-TIME DATA ERROR
IN FISCAL YEAR 2021.
THAT INCLUDED OVERREPORTING ON A
SINGLE VERY LARGE TRIAL.
THAT UNFORTUNATELY WAS FROZEN AT
THE NIH LEVEL AND LED TO
SIGNIFICANTLY HIGHER FY 2021
ENROLLMENT.
WE HAVE HOWEVER NOTED THAT IN
THE REPORT, TRIENNIAL REPORT
SUBMITTED TO THE BOARD.
WE ALSO USED CORRECTIVE DATA
THROUGHOUT THIS PRESENTATION.
NEXT SLIDE PLEASE.
SO SUMMARY OF INCLUSION RECORDS
AND ENROLLMENT FOR CLINICAL
RESEARCH STUDIES IS PRESENTED
HERE.
THE TOTAL ENROLLMENT RANGE FROM
OVER 3.2 MILLION TO 3.
7 MILLION, 84 TO 87% WHO
ENROLLED WERE FROM THE UNITED
STATES.
NEXT SLIDE PLEASE.
WHEN WE LOOK AT THE BREAKDOWN,
CLINICAL RESEARCH STUDIES BY SEX
AND GENDER, YOU'LL SEE THERE'S A
PREDOMINANT PERSONAL OF FEMALE
PARTICIPANTS ON THESE STUDIES,
IN EACH OF THE FISCAL YEARS.
THAT DOES REPRESENT THE LARGE
NUMBER OF STUDIES THAT DO IN
FEMALE MALIGNANCIES,
PARTICULARLY BREAST CANCER.
NEXT SLIDE PLEASE.
WHEN WE EXCLUDE ALL STUDIES IN
CLINICAL RESEARCH STUDIES THAT
ARE EXCLUSIVE JUST TO MEN OR
JUST TO WOMEN, YOU'LL SEE
THERE'S A MUCH MORE EVEN
BREAKDOWN BETWEEN THE PERCENTAGE
OF MEN AND WOMEN WHO ARE
PARTICIPANTS IN THE CLINICAL
RESEARCH STUDIES BY THE NCI AS
NOTED ON THIS SLIDE.
NEXT SLIDE PLEASE.
WHEN WE LOOK AT MINORITY
PARTICIPANTS BY RACE AND
ETHNICITY, WE LIKE TO POINT OUT
THAT THE NIH INCLUSION DATA
MINORITY PARTICIPANTS ARE
DEFINED AS PARTICIPANTS THAT
HAVE A NON-WHITE RACE, AND OR
ARE PARTICIPATES WHO ARE
HISPANIC OR LATINO.
YOU CAN SEE OVER THREE FISCAL
YEAR THERE WAS A STABLE
PERCENTAGE OF MINORITY
PARTICIPATION USING THAT
DEFINITION OF ABOUT 22%.
WHEN WE BREAK DOWN ETHNICITY,
FOR ALL CLINICAL RESEARCH
STUDIES, YOU'LL SEE THE
PERCENTAGE OF HISPANIC AND
LATINO PATIENTS HAS REMAINED
FAIRLY STABLE FROM ABOUT 9% OVER
THE COURSE OF EACH OF THE THREE
FISCAL YEARS.
THERE'S A LARGE NUMBER OF
UNREPORTED IS ETHNICITY,
SOMETIMES THAT REPRESENTS LARGE
OBSERVATIONAL STUDIES WHERE
THERE WERE HIGH NUMBERS OF
UNKNOWN OR NON-REPORTED
PARTICIPANTS.
BY RACE, YOU CAN SEE PERCENTAGE
BREAK DOWN FOR EACH OF THE
FISCAL YEARS, AS YOU CAN SEE THE
WHITE PARTICIPATION RANGED IN
60% RANGE, FAIRLY STABLE RATES
OF DIFFERENT MINORITY
REPRESENTATION ACROSS EACH OF
THE THREE FISCAL YEARS.
NEXT SLIDE PLEASE.
WE DO NOT HAVE TO REPORT BY THE
TRIENNIAL REPORT TO NIH,
BREAKDOWN BETWEEN EXTRAMURAL AND
INTRAMURAL STUDIES AT THE NCI.
WE DID PROVIDE THIS TO SHARE THE
BREAKDOWN WITH YOU.
IT SHOWS ROBUST ENROLLMENT OF
MILLIONS OF PATIENTS IN THE
EXTRAMURAL PROGRAMS AS WELL AS
INTRAMURAL PROGRAMS.
THERE ARE SOME SLIGHT
DIFFERENCES IN TERMS OF THE
NUMBER OR BREAKDOWN, EXCUSE ME,
IN GENDER FOR PATIENTS AS WELL
AS ETHNICITY AND RACE DEPENDING
ON THE TYPES OF CLINICAL TRIALS
DONE IN THE EXTRAMURAL AS
OPPOSED TO INTRAMURALLY AT NCI.
NEXT SLIDE PLEASE.
THERE ARE SPECIAL CONSIDERATIONS
GIVEN FOR NIH-DEFINED PHASE 3
TRIALS, WE PROVIDED DEFINITION
FOR TRIALS THAT NIH IS IN THE
MIDDLE OF THE SLIDE, DIFFICULT
TO READ, BUT WE DO CLEARLY
DEFINE ALL PHASE 3 CLINICAL
TRIALS DONE AT NCI BECAUSE WE'RE
REQUIRED TO HAVE DESIGNS THAT
PERMIT A VALID ANALYSIS ON THE
BASIS OF SEX, RACE, ETHNICITY.
AS SUCH WE PERFORM ADDITIONAL
REQUIREMENTS FOR NIH-DEFINED
PHASE 3 TRIALS, SO THAT WE
REPORT THOSE SEPARATELY AS PART
OF THE TRIENNIAL INCLUSION
REPORT.
AND I'LL BE DOING THAT ON THE
NEXT FEW SLIDES.
NEXT SLIDE.
HERE'S JUST A SUMMARY OF
INCLUSION RECORDS OF ENROLLMENT
NUMBERS FOR ALL PHASE 3 CLINICAL
TRIALS DONE AT THE NCI.
AS I POINTED OUT EARLIER, FISCAL
YEAR 2019, TWO LARGEST NATIONAL
PROGRAM ALSO, NCCOR AND NCTN
WHICH DO PHASE 3 CLINICAL
TRIALS, THEIR ENROLLMENT NUMBERS
WERE NOT INCLUDED BECAUSE THEY
ARE UNDERWENT RECOMPETITION THAT
YEAR BUT YOU CAN SEE IN 2020 AND
2021 A MORE THAN DOUBLING OF
TOTAL ENROLLMENT REFLECTING THE
CONTRIBUTION OF PARTICIPANTS IN
PHASE 3 CLINICAL TRIALS FROM
THOSE TWO NETWORKS.
IF YOU LOOK OVERALL IN ALL THREE
FISCAL YEARS PERCENT OF U.S.
ONLY RANGES FROM 74% TO 78%.
NEXT SLIDE PLEASE.
IF WE LOOK AT THE BREAKDOWN FOR
PHASE 3 TRIALS BY SEX AND GENDER
THERE'S PREDOMINANT PERCENTAGE
WHO ARE FEMALE.
YOU CAN SEE THAT WAS 60% IN FY
2019.
HOWEVER, FY 2020 AND FY 2021
THERE'S A SIGNIFICANT INCREASE
IN THE NUMBER OF PARTICIPANTS
WHO WERE FEMALE.
THIS HIGHER PROPORTION OF FEMALE
PARTICIPANTS REPORTED IN THOSE
TWO YEARS WAS LARGELY DRIVEN BY
SIGNIFICANT ENROLLMENT TO LARGE
NCCOR PREVENTION OR SCREENING
TRIAL, EXCUSE ME, IN EVALUATING
TWO DIFFERENT TYPES OF
MAMMOGRAPHY IN WOMEN WHO WERE
BEING SCREENED FOR BREAST
CANCER.
NEXT SLIDE.
IF WE WERE TO REMOVE ALL STUDIES
OR PHASE 3 TRIALS, EXCUSE ME, IN
WHICH THEY WERE DEVOTED, YOU HAD
TO BE JUST MALE OR JUST FEMALE,
TO BE ENROLLED.
YOU CAN SEE THAT THE PERCENTAGE
AND BREAKDOWN IS MORE EVENLY
DIVIDED.
EVEN THE INCREASE THAT YOU SEE
HERE IN FISCAL YEAR 2020 AND
2021 WHERE THERE'S A LARGER
PERCENTAGE OF FEMALE PATIENTS,
PARTICIPANTS, EXCUSE ME,
REPRESENTS THAT LARGE BREAST
CANCERS ENROLL MALES, THERE ARE
VERY FEW MALE PARTICIPANTS ON
THOSE TRIALS.
IF YOU EXCLUDED THOSE, THE
BREAKDOWN IS VERY EVEN BETWEEN
MEN AND WOMEN FOR OUR PHASE 3
CLINICAL TRIALS.
NEXT SLIDE PLEASE.
THIS SHOWS INCLUSION DATA FOR
ALL PHASE 3 CLINICAL TRIALS FOR
PROPORTION OF MINORITY
PARTICIPANTS BY RACE AND
ETHNICITY.
AGAIN, THAT'S ANYONE WHO
PARTICIPATES WITH A NON-WHITE OR
HISPANIC OR LATINO, AND THIS IS
FAIRLY STABLE OVER ALL OF THE
FISCAL YEARS AROUND THE MID-40%
RANGE.
NEXT SLIDE PLEASE.
HERE WE HAVE BREAKDOWN BY
ETHNICITY.
YOU CAN SEE THAT THE PERCENTAGE
OF HISPANIC AND LATINO PATIENTS,
PARTICIPANTS, HAS INCREASED FROM
FISCAL YEAR 2019 UP TO FISCAL
2021.
WE DID NOTE THAT PARTICULARLY
THE LARGE INCREASES IN HISPANIC
OR BUMP IN HISPANIC LATINO
PERCENTAGE IN 2020 AND 2021 ALSO
RELATES TO A VERY HEAVY AND
STRONG PARTICIPATION BY HISPANIC
AND LATINO PATIENTS BOTH U.S.
AND EX- EX-U.S. FOR THE TMIST
TRIAL THAT THE NCCOR WAS
RUNNING, EVALUATING TWO TYPES OF
MAMMOGRAPHY FOR WOMEN SCREENED
FOR BREAST CANCER.
THIS IS BY RACE.
THERE ARE SOME PARTICULAR ISSUES
IN THIS TRIENNIAL REPORT DUE TO
THE DATA IN THE PARTICULAR
STUDIES, IN FY 2019 EXCLUDES TWO
LARGE NATIONAL CLINICAL TRIALS
NETWORKS SUPPORTED IN THE
EXTRAMURAL COMMUNITY, THERE WAS
A LARGE PERCENTAGE OF BLACK AND
AFRICAN AMERICAN AS WELL AS
ASIAN PATIENTS, DUE TO
PARTICULAR TRIALS THAT WERE
FOCUSED ON THOSE PARTICULAR --
THAT THOSE PARTICULAR TYPES OF
PARTICIPANTS.
WHEN WE WENT IN TO FISCAL YEAR
2020 AND 2021, ADDED THAT, THE
LARGE NATIONAL CLINICAL TRIALS
NETWORK ALSO, THE NCTN AND
NCCOR, YOU CAN SEE THERE WAS A
DROP IN BOTH ASIAN
PARTICIPATION, OVER INTO FISCAL
YEAR 2021.
AS WELL AS A DROP IN THE NUMBER
OR PERCENTAGE OVERALL OF BLACK
AND AFRICAN AMERICAN PATIENTS.
THERE WAS ALSO A ONE-TIME ERROR
IN TERMS OF CATEGORY OF MORE
THAN ONE RACE, AS OUR TRIALS
HAVE BECOME MORE COMPLEX ACROSS
THE BOARD BOTH EARLY PHASE AND
LATE PHASE CLINICAL TRIALS THERE
WAS COMPLEXITIES IN TERMS OF THE
NUMBER OF DIFFERENT STEPS A
PATIENT COULD GO ON TO IN
PARTICULAR CLINICAL TRIALS
PARTICULARLY LARGE CANCER
TREATMENT TRIALS THAT
UNFORTUNATELY LED TO AN ERROR IN
REPORTING OF MORE THAN ONE RACE.
THAT ERROR HAS BEEN CORRECTED.
YOU COULD NOT CORRECT FOR THE
PRESENTATION BUT GOING FORWARD
IN THE TRIENNIAL REPORTS THAT
WILL BE CORRECTED.
AS BEST AS WE CAN DETERMINE,
THAT ERROR SIMPLY MEANT PROBABLY
PERCENTAGE OF MORE THAN ONE RACE
IN FISCAL YEAR 2020 AND 2021
PROBABLY RESEMBLES MORE WHAT WAS
IN FISCAL YEAR 2019 AND EARLY
TRIENNIAL REPORTS, AND WOULD BE
EVENLY DISTRIBUTED ACROSS THE
OTHER PERCENTAGES IF IT HAD BEEN
APPROPRIATELY REPORTED.
NEXT SLIDE PLEASE.
SO THAT IS THE END OF OUR
PRESENTATION.
WE REALLY WOULD LIKE TO THANK
ALL THE NCI STAFF AND ALL THE
SUPPORTING INVESTIGATORS WHO
WORKED TO TRY TO INCLUDE AND
RECRUIT AS DIVERSE A PATIENT AND
PARTICIPANT POPULATION AS THEY
CAN TO ALL THE CLINICAL RESEARCH
DONE AT NCI AND WORKED TO
ENSURE ACCURACY OF DATA.
WE WOULD BE HAPPY TO ANSWER
QUESTIONS.
THANK YOU SO MUCH.
>> THANKS, MEG.
WE ONLY ENVIRONMENTAL A COUPLE
MINUTES.
PROBABLY ONLY HAVE TIME FOR ONE
OR TWO QUESTIONS.
I'LL YIELD TO ELECTRA AND I SEE
HOWARD'S HAND UP.
ELECTRA FIRST.
>> I JUST WANT TO MAKE TWO
SUGGESTIONS, AND OFFLINE I'M
HAPPY TO CHAT WITH YOU ABOUT
THIS, I EXPLORED THIS IN GREAT
DETAIL.
FIRST IS UNKNOWNS, THAT'S TOO
HIGH.
TOO HIGH.
I'D LIKE TO TALK TO YOU ABOUT
WHAT WE'RE SEEING THAT CAUSES
THAT THAT SO WE CAN TALK OFFLINE
ABOUT THAT.
THE SECOND THING, IT WOULD BE
VERY HELPFUL TO CONSIDER WHEN
YOU'RE DOING THESE PRESENTATIONS
TO HELP US ASSESS HOW THAT IS
REPRESENTATIVE OF THE
DEMOGRAPHICS IN THE UNITED
STATES.
YOU MIGHT WANT TO CONSIDER WHAT
WE IN THE CANCER CENTER WORLD
HAVE TO DO.
>> OKAY.
>> CLINICAL TRIAL DEMOGRAPHICS,
AT LEAST SHOW US THE PROPORTION
OF PEOPLE IN THE U.S. BY EACH OF
THOSE GENDER AND RACIAL GROUPS
TO GIVE US SOME SORT OF
MEASURING STICK.
AGAIN, I'M HAPPY TO CHAT WITH
YOU OFFLINE ABOUT THAT.
THANK YOU, THANK YOU VERY MUCH.
AND CONGRATULATIONS TO EVERYBODY
FOR SUPERB ACCRUAL, DIVERSE
ACCRUAL.
THANK YOU.
>> THANKS, ELECTRA.
HOWARD?
>> SURE.
MY QUESTIONS ARE LIKE ELECTRA'S
ACTUALLY.
FIRST POINT OF CLARIFICATION,
WHEN YOU'RE TALKING ABOUT THIS
GREAT DATA YOU'RE SHOWING US FOR
INCLUSION, DOES IT ACTUALLY ALSO
SHOW THE COMPLETERS, WHERE
ANNUAL SILLS CAN -- ANALYSIS CAN
BE DONE ABOUT CHOSEN PRIMARY
ENDPOINT AGAINST THE DEMOGRAPHIC
OR JUST WHO GETS INITIALLY
ENROLLED ON DAY ONE OF THE START
OF THE TRIAL IS WHAT YOU'RE
SHOWING US?
>> THIS IS PRIMARILY -- YES,
YOU'RE RIGHT, ENROLLMENT.
SOMETIMES ENROLLMENT IS ASSESSED
BY THE INDIVIDUAL PROGRAMS AND
INDIVIDUAL TRIAL, AFTER
WITHDRAWALS FOR OTHER REASONS
BUT I'M NOT -- ARE YOU ASKING
WHETHER IT'S ENROLLMENT AFTER
PATIENTS MAY HAVE WITHDRAWN
CONSENT OR SOME OTHER REASON
THEY DIDN'T GET OR CONTRIBUTE TO
THE PRIMARY ENDPOINT?
THERE CAN BE MANY REASONS.
THEY COME OFF, TOXICITY, I'M NOT
SURE I'M UNDERSTANDING YOUR
QUESTIONS.
>> WELL, DO YOU THINK IT WOULD
BE A COMPLEMENT TO THE KIND OF
DATA YOU'RE COLLECTING TO ALSO
SHOW COMPLETERS, AND HOW MANY OF
THE COMPLETERS THAT COMPLETE THE
END OF THE TRIAL AS DEFINED BY
THE PROTOCOL, AND HOW MANY OF
THOSE ARE IN DIFFERENT MINORITY
GROUPS.
I THINK IT WOULD BE.
>> OKAY.
>> BUT MY QUESTION REALLY IS DO
YOU THINK OR DO OTHERS IN THE
GROUP HERE HAVE ANY THOUGHTS
ABOUT UNDERSTANDING QUALITY BY
DESIGN OPTIONS TO MITIGATE, TO
BASICALLY UNDERSTAND WHAT THE
ROOT CAUSES ARE OF THIS -- WHEN
WE SEE OVER 10% MISSING DATA, IN
TRIALS AND INDUSTRY, THAT IS A
BIG FLAG.
AND WE TRY AND UNDERSTAND THAT
EARLY IN THE TRIALS.
WE'RE SEEING 10% IN THE FIRST
20% ENROLLED, WE JUMP IN AND
START TO DO SOMETHING FOR THE
REST OF THE 80% SO WE'RE NOT
GETTING THAT MISSING DATA.
HERE WE'RE SEEING IT KIND OF AT
THE END OF THE TRIAL BUT I
UNDERSTAND NCI TRIALS ARE
DIFFERENT THAN INDUSTRY TRIALS
BECAUSE OF, YOU KNOW, THE
MONITORING FREQUENCY AND ALL
THAT AND ABILITY TO REACT TO
DATA.
BUT I'M JUST CONCERNED ABOUT
WHAT'S GOING ON NOW IN TODAY'S
TRIALS WITH THE DECENTRALIZATION
BECAUSE OF THE COVID AND THE
CHALLENGES OF DROPOUTS.
YOU KNOW, ARE THINGS GOING TO
GET BETTER OR WORSE?
IS IT REALLY TIME TO START
THINKING ABOUT WAYS THAT WE CAN
BETTER INSTITUTE WHAT WE CALL
QUALITY BY DESIGN FOR THESE
KINDS OF ISSUES?
>> WELL, AS ELECTRA SAID WE
WOULD BE VERY INTERESTED IN
UNDERSTANDING WAYS YOU'VE TRIED
TO ASSESS AND TRIED TO FIGURE
OUT WHY THERE ARE SO MANY
UNKNOWNS, WHAT LEADS TO THAT,
HOW TO CORRECT THAT AS MUCH AS
POSSIBLE.
WE SEE IN LARGER STUDIES, PHASE
3 CLINICAL TRIALS HAVE A
DIFFERENT PERCENTAGE BUT STILL
BETWEEN 3 1/2 TO 4 1/2%, WE
WOULD LIKE TO KNOW ACROSS
CLINICAL RESEARCH AND TRY TO
CORRECT THAT, VERY HELPFUL TO
UNDERSTAND AND GET YOUR INPUT.
>> THANKS.
THERE ARE A COUPLE OF OTHER --
WE'RE A COUPLE MINUTES OVER.
BOY, THIS IS AN IMPORTANT
DISCUSSION.
WE'RE GOING TO EAT INTO OUR
BREAK PROBABLY.
FOR ME, IT'S ALWAYS GOOD TO SEE
THERAPEUTIC VERSUS
NON-THERAPEUTIC.
THAT'S WHERE WE START TO SEE
HUGE DIFFERENCES AND SOME
DISPARITIES, WHERE THEY JUMP
OUT.
AND WITHOUT SEEING IT, YOU KNOW,
YOU CAN GET A FALSE IMPRESSION
OF SORTS THAT THERE ARE NO
DISPARITIES AND MINORITY
PARTICIPATION IN TRIALS.
I DON'T KNOW IF IT'S POSSIBLE --
I KNOW THERE'S ONLY SO MUCH TIME
BUT AT SOME POINT IT WOULD BE
GREAT TO SEE THERAPEUTIC VERSUS
NON-THERAPEUTIC PARTICULARLY
CONSIDERING RACE, GENDER, AGE.
ASHANI HAS A QUESTION ABOUT AGE.
>> I SEE THERE'S AN ANSWER IN
THE CHAT THAT I HAVEN'T HAD A
CHANCE TO READ YET.
>> OKAY.
>> WHICH WAS ASKING ABOUT JAMA
ONCOLOGY PUBLISHED A STUDY
SHOWING MOST NCI CLINICAL
TRIALS, AVERAGE PATIENT AGE IS
ALMOST A DECADE YOUNGER THAN THE
PATIENT POPULATION.
AND THAT'S AN ISSUE BECAUSE WE
KNOW THAT YOUNGER PATIENTS AND
OLDER PATIENTS RESPOND VERY
DIFFERENTLY EVEN TO THINGS LIKE
TARGETED THERAPY.
SO I'LL READ THE ANSWER IN THE
CHAT.
>> GREAT.
>> YEAH, ONE THING I DIDN'T HAVE
TIME TO EXPLAIN, THERE WAS
INCLUSION ACROSS THE LIFESPAN.
SO FUTURE REPORTS, WE WILL BE
REPORTING ON AGE AND BE ABLE TO
GIVE YOU MORE OF THAT BREAKDOWN.
I KNOW WITHIN INDIVIDUAL
PROGRAMS ACROSS THE NCI WE LOOK
AT EACH FIGURE YOU WERE TALKING
ABOUT TO SEE, AGAIN, HOW
REPRESENTATIVE WE ARE OF THE
PATIENT POPULATION.
>> SO THIS IS -- THANKS, MEG.
THIS IS A REPORT.
AS A BOARD WE HAVE TO CALL A
VOTE TO APPROVE THE REPORT THAT
WAS PRESENTED.
SO DO WE HAVE A MOTION --
>> NOT TO APPROVE THE REPORT, TO
ACCEPT THE REPORT.
>> TO ACCEPT THE REPORT.
TO ACCEPT THE REPORT.
DO WE HAVE A MOTION TO ACCEPT
THIS REPORT THAT WAS JUST
PRESENTED.
>> SO MOVED.
>> SECOND?
MOVE TO SECOND.
WE SHOULD VOTE.
DISCUSSION?
WE SHOULD VOTE.
CAN I SEE THE HANDS FOR YAY.
OKAY.
ANY HANDS FOR NAY?
ANY ABSTENTIONS?
OKAY.
THE YAYS HAVE IT.
>> THANK YOU VERY MUCH.
>> THANK YOU, MEG.
NEXT WE HAVE FINAL PRESENTATION
FOR THIS PART OF THE MEETING,
THE NATURAL PRODUCTS PROGRAM
GIVEN BY DR. BARRY O'KEEFE,
DIRECTOR FOR MOLECULAR TARGETS
PROGRAM.
THE CENTER FOR CANCER RESEARCH.
NATURAL PRODUCTS BRANCH,
DEVELOPMENTAL THERAPEUTICS
PROGRAM DIVISION OF CANCER
TREATMENT AND DIAGNOSIS.
BARRY?
>> THANK YOU VERY MUCH FOR THIS
OPPORTUNITY TO GET ADVICE OF THE
BOARD AND INPUT ON THIS PROGRAM,
THE NCI HAS INITIATED.
AS MANY OF YOU ARE FAMILIAR,
NATURAL PRODUCTS MADE
SIGNIFICANT CONTRIBUTION, I'M
SHOWING DIVERSE CHEMICAL
STRUCTURES THAT RESULT FROM
NATURAL PRODUCTS STUDIES
APPROVED AS ANTI-CANCER AGENTS
OVER THE LAST 10 TO 15 YEARS,
LOOKING AT THE TOTALITY OF
NATURAL PRODUCTS, SMALL MOLECULE
SCAFFOLD USE IN THE
PHARMACOPEIA, APPROVED DRUGS FOR
ALL USES NATURAL PRODUCTS MAKE
UP 25 TO 30% ON AVERAGE OVER THE
YEARS.
WHICH IS SIGNIFICANT IMPACT.
HOWEVER, WHEN WE TAKE A LOOK AT
CURRENT LEVEL OF HIGH-THROUGHPUT
SCREENING, ONE OF THE MAIN
AVENUES BY WHICH SMALL MOLECULES
ARE DISCOVERED AND BECOME
POTENTIAL LEAD AVENUES FOR
DRUGS, WE SEE THAT
HIGH-THROUGHPUT SCREENING
INCREASED SIGNIFICANTLY THIS
CENTURY, HAVE NOT SEEN SIMILAR
INCREASE IN AMOUNT OF NATURAL
PRODUCTS INCLUDED IN ASSAYS, IN
BLUE ONLY A SMALL PERCENTAGE, 1%
INCLUDE NATURAL PRODUCT SAMPLES.
WHY IS THIS?
THERE'S SEVERAL REASONS.
THIS IMAGE SHOWS CLASSIC
EXAMPLE, THIS IS PLATE OF 96
CRUDE NATURAL PRODUCT EXTRACTS,
DIFFICULT TO SCREEN, CONTAIN
NUMEROUS POUNDS FOUND AT
DIFFERENT CONCENTRATIONS.
ALSO THE PURIFICATION AND
STRUCTURAL ELUCIDATION OF THE
ACTIVE COMPONENTS WITHIN
EXTRACTS WAS TIME CONSUMING AND
DIDN'T MESH WELL WITH
HIGH-THROUGHPUT SCREENING
SCHEDULES RESULTING IN A SLOW
PROCESS INCREASING COSTS IN THE
CHEMISTRY SIDE OF THINGS AS WELL
AS SCREENING SIDE OF THINGS
WHERE ASSAYS HAD TO BE KEPT UP
FOR LONG PERIODS OF TIME.
AND SO THERE WAS A NEED TO
ADDRESS THESE CHALLENGES IN
ORDER TO EFFICIENTLY ACCESS THE
CHEMICAL DIVERSITY AND NATURAL
PRODUCTS.
AND WHY WOULD THE NCI BE
INTERESTED?
THE NCI HAS ONE OF THE LARGEST
LIBRARIES OF CRUDE NATURAL
PRODUCT EXTRACTS IN THE WORLD.
A MAP DEPICTS WHERE COLLECTED,
230,000 IN THE LIBRARY, ORIGINS
FROM PLANTS, MARINE ORGANISMS,
MICROBIAL SOURCE ORGANISMS AS
WELL.
WE HAD A LARGE LIBRARY OF CRUDE
EXTRACTS BUT FEWER PEOPLE
INTERESTED IN SCREENING THEM.
THE NCI INSTIGATED A
COLLABORATION.
AND THE NPNPD FACILITATES
INTRAMURAL AND EXTRAMURAL
RESEARCH AND ADDRESSING
CHALLENGES IN DRUG DISCOVERY
FUNDED BY THE CANCER MOONSHOT
PROGRAM, A MULTI-FACETED PROGRAM
AS SHOWN IN THIS DIAGRAM IN THE
CENTER.
IT HAS SEVERAL SPECIFIC AIMS
WHICH I'M SHARING HERE.
PRIMARILY INITIALLY TO CREATE A
PRE-FRACTIONATED OR SEMI
PURIFIED HIGH-THROUGHPUT, TO
EXPAND AVAILABLE FROM CULTURABLE
ORGANISMS.
WE WERE GOING TO PROVIDE THIS
PRE-FRACTIONATED LIBRARY TO
SCREENING CENTERS WORLDWIDE FOR
FREE.
WE ALSO WERE GOING TO ENCOURAGE
THE HIGH-THROUGHPUT SCREENING
SUPPORT FOR RESEARCHERS TO
ENABLE THIS, PARTLY BY PROVIDING
FASTER ANALYTICAL RESOURCES,
ISOLATION, STRUCTURAL
ELUCIDATION, TO EXPEDITE PIPE
LINES AND PULL THIS AGO IN A
BIOINFORMATICS AND DATABASES TO
INCREASE EFFICIENCY OF THE
PROGRAM BUT ALSO TO BROADEN
INPUT AND IMPACT.
SO, THE FIRST THING WAS
PRE-FRACTIONATION PLANS.
THIS IS IN THIS CASE, WE WERE
SET OUT TO MAKE A LIBRARY OF A
MILLION SEMI PURE AND NATURAL
PRODUCT FRACTIONS, SUPPLY THIS
TO RESEARCHES FOR FREE IN PLATED
AND 384 WELL PLATES
AND OPEN THE USE OF THIS LIBRARY
FOR ALL SCREENING LABS AGAINST
ALL DISEASE STATES, WITH THE
ASSUMPTION THAT WE WOULD FIND
OUT MORE ABOUT BASIC BIOLOGY AS
WELL AS CHEMISTRY THEREIN, AND
THAT IT MIGHT NOT SEEM IMPORTANT
RIGHT NOW TO CANCER AS CANCER
BIOLOGY DEVELOPS OVER THE YEARS,
20 YEARS FROM NOW THAT COULD BE
AN IMPORTANT TARGET FOR CANCER.
AND THEN WE WANTED TO MAKE SURE
THIS LIBRARY WOULDN'T IMPROVE
ONLY THE EFFICIENCY OF SCREENING
BUT ALSO OF DOWNSTREAM CHEMISTRY
EFFORTS.
SO THERE'S A LOT OF METHOD
DEVELOPMENT WHICH I WON'T GO
INTO IN DETAIL HERE BUT JUST TO
GIVE YOU A FEW BULLET POINTS,
THE PURIFICATION OF THESE
EXTRACTS IS BASED ON CHEMICAL
POLARITY, FOR YIELD OF MASS,
COMPOUND SEPARATION, BIOLOGICAL
ACTIVITY RETENTION AND A SYSTEM
THAT COULD PRODUCE 150,000 A
YEAR, TEN TIMES WHAT ANYBODY HAD
TRIED TO DO BEFORE.
AND WE ALSO NEEDED TO DO THAT
WITH SUFFICIENT MASS TO SUPPORT
A SCREENING PROGRAM FOR AT LEAST
A DECADE.
AND THEN WE ALSO NEEDED TO HAVE
THIS IN AN AUTOMATED SYSTEM SO
IT WAS EASILY AND FACILELY
ACCESSED AS RESEARCH MOVED
FORWARD OVER ENSUING YEARS.
THIS WAS TAKING THE WAY NATURAL
PRODUCTS HAD BEEN DONE FOR THE
LAST 50 TO 100 YEARS, WHICH WAS
SLOW, INDIVIDUAL COLUMNS,
RESEARCHESSERS, TURNING IT INTO
SOMETHING AUTOMATED AND AMENABLE
TO MODERN DRUG DISCOVERY
PARADIGMS.
SO TO MAKE A LONG STORY SHORT WE
OPTIMIZED EVERYTHING AND
AUTOMATED EVERYTHING TO A LARGE
EXTENT.
HERE I'M SHOWING A VARIETY OF
INSTRUMENTATION WE HAD TO MODIFY
TO BE ABLE TO USE FOR THE
SYSTEM.
SO THE FOLKS IN THE LAB ACTUALLY
MODIFIED A VARIETY OF ROBOTIC
SYSTEMS TO HANDLE THESE NEW
TASKS, I'D LIKE TO SAY HERE
SHOWING THAT THIS WAS HIGHLY
REPRODUCIBLE WHICH WAS VERY
IMPORTANT THAT WE COULD DO THIS
ONE MONTH AND DO THE SAME THING
A MONTH LATER AND GET THE SAME
RESULTS.
SO WHAT I'M SHOWING IN GRAPH A
IS DEPICTION OF THE MASS YIELD
OF 88 CRUDE EXTRACTS, EACH
PRE-FRACTIONATED, A MONTH LATER
PRE-FRACTIONATED AGAIN.
YOU CAN SEE WE GET A
REPRODUCIBLE MASS YIELD IN THE
INDIVIDUAL FRACTIONS.
SIMILARLY WE TESTED FRACTIONS
FOR BIOLOGICAL ACTIVITY IN THE
NCI 60 ASSAY AND AGAIN THEY HAD
HIGHLY REPRODUCIBLE ACTIVITY
PROFILES.
FOLLOW THAT UP, WE ALSO WANTED
TO DO PRINCIPAL COMPONENT
ANALYSIS TO GET AN IDEA HOW MANY
PURE COMPOUND WERE IN THESE
FRACTIONS.
WHAT WOULD PEOPLE BE LOOKING AT.
WE GENERALLY USE TOTAL MASS
SPECTROMETRY AS OUR MEASURE,
IT'S PROBABLY THE MOST ACCURATE,
THE LARGEST.
WE SEPARATE THINGS INTO SEVEN
FRACTIONS FOR EACH CRUDE EXTRACT
AND THERE'S AN AVERAGE OF 20 TO
25 COMPOUNDS PER FRACTION IN
GENERAL.
SO THEN AT THIS POINT WHERE ARE
WE?
WE HAVE NOW PRODUCED OVER 525,
000 NATURAL PRODUCT FRACTIONS,
325,000 RELEASED TO RESEARCH
COMMUNITY, ANTICIPATE 175,000
RELEASED WITHIN THE NEXT SIX
WEEKS.
AND WE HAVE CREATED AND PLATED
OVER 20 MILLION WELLS OF THESE
TO BE READY TO SHIP TO SCREENING
CENTERS AND HAVE ACTUALLY
SHIPPED OVER 5 MILLION SAMPLES
AT THIS POINT.
WHICH WAS GREATER THAN THE
PREVIOUS 40 YEARS OF NATURAL
PRODUCT BRANCH SHIPMENTS
COMBINED, ABOUT AN AVERAGE OF
150 FRACTIONS GOING OUT PER
MONTH.
WE HAVE PUBLICATIONS ON METHOD,
LIBRARY, AND HOW TO USE IN
CELL-BASED AND CELL-FREE
SCREENS.
IMPORTANTLY, THE ADAPTATION OF
THIS METHOD AND TECHNOLOGY MADE
AVAILABLE, IMPORTANT TO GET
OTHERS TO USE SYSTEMS.
THE AUTOMATED ROBOTIC SYSTEM IN
THE UPPER RIGHT-HAND CORNER
HERE, FOR EXAMPLE, WE WORKED
WITH A GROUP IN SOUTH AFRICA
THAT HAD 30 TO 40,000 NATIVE
PLANTS FROM SOUTH AFRICA THAT
THEY HAVE NOW PUT THROUGH THE
SAME SYSTEMS.
WE'VE BEEN WORKING WITH THEM.
THEY RECENTLY HAD A GRANT HIGHLY
RATED FOR USE FOR DISEASES OF
IMPORTANCE TO AFRICA, IN
COLLABORATION WITH PEOPLE IN
SOUTH AFRICA, CAMEROON,
TANZANIA.
WE ALSO WANT TO EXPAND CHEMICAL
DIVERSITY FROM CULTURAL
ORGANISMS.
WE'VE DONE THIS THROUGH A
CITIZEN SCIENCE PROGRAM
COLLABORATION WITH UNIVERSITY OF
OKLAHOMA WHICH BROUGHT 24,000
FUNGAL SAMPLES TO THE NCI.
I'M SHOWING A MAP OF WHERE THESE
ARE FROM IN THE UNITED STATES.
WE ALSO HAVE A NEW FERMENTATION
FACILITY AT THE NCI IN FREDERICK
TO RAPIDLY PRODUCES THEM, GROW
AND EXTRACT THEM.
I'M SHOWING BREAKDOWN OF THE
TAXONOMY OF THESE ORGANISM ALSO,
IMPORTANTLY WE HAVE SEQUENCED
ALL THESE, PHOTOGRAPHED THEM,
CRYOVIALED THEM, TO PROVIDE
EXTRACTS TO RESEARCHERS BUT
ORGANISMS THEMSELVES AND ENSURED
THERE IS A GREAT AMOUNT OF
TAXONOMIC DIVERSITY BY REQUIRES
ITS SEQUENCING AND ENSURING EACH
ORGANISM THAT WAS ACCEPTED INTO
THE COLLECTION HAS TO BE 99.5%
DIFFERENT BY ITS SEQUENCE IN A
ZIP CODE IN THE UNITED STATES.
TO SHOW EVIDENCE FROM A PILOT
PROGRAM WE'VE DONE THIS SHOWS
CHEMICAL DIVERSITY, ALL
COMPONENTS THE SHOW CYTOTOXIC
ACTIVITY IN THE NCI 60 ASSAY,
THIS WAS INITIAL STUDY, PROBABLY
WILL PUBLISH, INFORMATION ABOUT
THIS LIBRARY, THIS CALENDAR
YEAR.
WE THEN WANTED TO MAKE SURE THIS
GOT OUT TO PEOPLE SO WE HAVE
PROVIDED THIS LIBRARY AT THIS
POINT EXECUTED MORE THAN 40 MTA
AGREEMENTS WITH A VARIETY OF
UNIVERSITIES AND RESEARCH
INSTITUTIONS AROUND THE COUNTRY
AND AROUND THE WORLD.
SO THAT'S ABOUT ONE MTA EVERY
MONTH SO FAR, SINCE THEN
RELEASED THE FIRST LIBRARY, HAD
PARTICIPATION FROM INDUSTRY AND
U.S. GOVERNMENT.
AS FAR AS U.S. GOVERNMENT
AGENCIES, I AM DETAILING A FEW
OF THESE INTERACTIONS HERE.
FOR EXAMPLE, WITH NIAID, WE HAVE
A JOINT INTERAGENCY AGREEMENT
NOW, AND HAVE WORKED WITH THEM
TO SCREEN THIS LIBRARY AGAINST
ESKAPE PATHOGENS FOR ANTIBIOTIC
DISCOVERY.
WE WORK WITH WALTER REED AND
DEPARTMENT OF DEFENSE TO LOOK AT
SCREENING THESE AGAINST MALARIA
AND LEISHMANIASIS.
NCCIH AND NCATS COMBINED WITH
THE "HEAL" PROGRAM TO SCREEN
THESE FRACTIONS AGAINST TARGETS
THAT ARE ASSOCIATED WITH THE
HEAL INITIATIVE.
AND SO WE'VE PROVIDED THE
LIBRARY TO NCATS, AND THEY
SCREEN WITH TARGETS THAT ARE
DERIVED FROM EXTRAMURAL
RESEARCHERS, AND THE NCI
PARTICIPATE BY ISOLATING AND
DIFFERENTING THE ACTIVE
COMPONENTS.
FINALLY, NOAA HAS WORKED WITH US
FOR COLLECTION OF MARINE
ORGANISMS FOR BIOMEDICAL
RESEARCH THAT COULD BE ADDED TO
THIS PROGRAM.
THE GOAL IS TO GET EVERYTHING
YOU ABOUT THE MAJORITY OF
RESEARCHERS DON'T HAVE THE
CHEMISTRY EXPERTISE PERHAPS IN
HOUSE TO HELP WITH THAT.
SO WE BUILT SYSTEMS THAT GET
HIGH-THROUGHPUT FAST TO HELP
RESEARCHERS WITH THAT SO CREATED
AUTOMATED SECOND STAGE
PURIFICATION SYSTEM TO HELP UP
TO 500 SAMPLES OF A HIT LIST
FROM SOMEBODY OF FRACTIONS
ACTIVE IN THEIR SCREENS, WE
COULD TAKE THOSE AND PURIFY THEM
INTO 22 SUBFRACTIONS FOR EACH
FRACTION, DRIP THOSE INTO
HIGH-THROUGHPUT SCREENING
PLATES, DRY AND SHIP OVER 10,000
FRACTIONS TO THOSE SCREENING
LABS WITHIN TWO WEEKS.
THIS GENERATES VALUABLE CHEMICAL
INFORMATION, NMR, MASS SPEC,
REDUCES COST BECAUSE NOW LABS
DON'T HAVE TO KEEP ASSAYS UP FOR
QUITE SUCH A LONG STRETCH OF
TIME, AND ALSO REDUCES COST OF
CHEMISTRY.
IMPORTANTLY CONSERVES EXTRACTS.
WE CAN GET SAME DATA FROM ONE
MILLIGRAM OF A FRACTION THAT
USED TO TAKE A GRAM OF EXTRACT.
AND SO THIS LIBRARY OF 200,000
EXTRACTS WILL BE PRESERVED FOR A
MUCH LONGER PERIOD OF TIME.
BRIEF DETAILS OF WHERE WE ARE SO
FAR, WE'VE DONE THIS WITH
SEVERAL PROJECTS, SEVERAL
GROUPS, BAYLOR, UNIVERSITY OF
TEXAS, WALTER REED, 65,000
PURIFIED SUBTRACTIONS, 70% OF
THE TIME FROM THESE SUBFRACTIONS
WE CAN DETERMINE THE COMPOUND
CLASS OF THE ACTIVE COMPONENT
WITH NO FURTHER PURIFICATION.
THIS REQUIRES SIGNIFICANTLY LESS
CHEMIST TIME, ONE TO TWO MONTHS.
80% OF THE TIME WE SEE ACTIVITY
IN ONE OF THESE FRACTIONS, WE DO
NOT SEE ACTIVITY FROM THE CRUDE
EXTRACT, UNCOVERING CHEMICAL
DIVERSITY.
THESE METHODS AND PROCEDURES AND
AUTOMATION WE USE WERE PUBLISHED
IN 2020.
AND ONE THING WE WANTED TO DO TO
CHECK WHAT CAME OUT OF THIS
PROCESS WAS TO LOOK ARE THESE
DRUG-LIKE MOLECULES AT THE END,
THINGS THAT COULD ACTUALLY BE
DEVELOPED?
AND SO WE COMPARED THE COMPOUNDS
THAT CAME OUT OF OUR PILOT
SCREEN BY PRINCIPAL COMPONENT
ANALYSIS, THREE COMPONENTS MAKE
UP THE MAJORITY OF DIFFERENTIAL
BETWEEN COMPOUNDS, MOLECULAR
WEIGHT, LIPO VOW LISTTY AND
COMPOUNDS.
LARGELY THEY OVERLAP BETWEEN
1981 AND 2010 INDICATING WE SEEM
TO BE IN AN AREA OF CHEMICAL
DIVERSITY THAT HAS PROVEN
SUCCESSFUL IN THE PAST TO
DEVELOP.
THERE'S A LOT OF DATA INVOLVED.
WE DEVELOPED A WEB ACCESSIBLE
AND SECURE SYSTEM TO TRACK
EVERYTHING FROM THE PRODUCTION
OF FRACTIONS TO PLATED SAMPLES
TO EACH INDIVIDUAL PROJECT WITH
EACH INDIVIDUAL MTA HOLDER.
AS WELL AS EVERY SOURCE ORGANISM
TO GPS COORDINATES, CHEMISTRY
AND BIOLOGY.
I'M GOING INTO DETAIL ON THREE
DIFFERENT OUTCOMES HERE TO
DETAIL NOW THAT WE HAVE THIS CAN
WE DO SOME THINGS MAYBE WE
COULDN'T DO BEFORE WITH NATURAL
PRODUCTS.
FIRST BIOPHYSICAL ASSAY, BETTER
BEHAVED THAN CRUDE EXTRACTS.
IN THIS CASE DIFFERENTIAL
SCANNING FLUOROMETRY.
WE ARE TAKING THIS OVER A
TEMPERATURE GRADIENT TO SEE IT'S
MELTING, ADD COMPOUNDS TO SEE IF
THEY CAN ALTER THAT MELTING
TEMPERATURE OF THAT microRNA
AND FRACTIONS, DETECTING
STABILIZATION AND
DESTABILIZATION, NEVER USED WITH
NATURAL PRODUCT EXTRACTS.
THIS IS NOW REDUCED TO PRACTICE
IN THE NCI AND WE CAN DO THIS
ASSAY IN SEVEN MICRO LITERS PER
WELL.
INITIAL RESULT, THIS COMPOUND
WAS ABLE TO MODIFY THE MELTING
TEMPERATURE PREMIER 21 BY 3.4
DEGREES CENTIGRADE, FROM THIS
MICRO YOU SEE HERE.
WHEN WE FURTHER STUDIED, WE SAW
THAT IT ACTUALLY INDUCED A
SECOND FORM THAT YOU SEE IN
PURPLE HERE IN THE MELTING
CURVE, HIGHER TEMPERATURE
MELTING FORM OF PRE-MIR-21,
SEEING A CUPPER COILED FORM OF
PRE-MIR-21 -- SUPERCOILED FORM
OF PRE-MIR-21, LESS SUITABLE FOR
RISK, ENDED UP RESULTING IN LESS
MIR-21 IN COLON CANCER CELLS.
WE SAW AN INCREASE, RELATIVE TO
MIR- 2 1 LEVELS.
THIS SHOWS NATURAL PRODUCTS CAN
APPROACH TAR GETS PEOPLE DIDN'T
THINK WERE APPROACHABLE FOR
NATURAL PRODUCTS WITH ASSAYS
THEY DIDN'T CONSIDER WOULD BE
AMENABLE TO NATURAL PRODUCTS
SCREENING.
HERE I'D LIKE TO MENTION WE CAN
FIND POTENTIAL BIOTHERAPEUTICS
FROM NATURAL PRODUCTS.
HERE THIS WAS AN ENZYMATIC ASSAY
LOOKING AT INHIBITION IMPORTANT
FOR RESISTANCE TO TOP1
INHIBITORS, AN ALLOSTERIC
INHIBITOR BOUND TO REGULATORY
DOMAIN OF THE PROTEIN, HAD A
UNIQUE STRUCTURE AND DEFINED A
WHOLE NEW CLASS OF PEPTIDES WITH
UNIQUE TYROSYL LOCK STRUCTURED
LOCKED IN THREE DIMENSIONAL
SPACE STABILIZING THE UNIT, NOW
PATENTED AND ALREADY IN ACTIVE
LICENSING BY THE NCI FOR
CLINICAL -- FOR THERAPEUTIC
DEVELOPMENT I SHOULD SAY.
FINALLY WE CAN USE THE DATA THAT
WE'RE DERIVING, IF WE LOOK AT
THE DATA FROM ALL THE NCI 60
DATA WITH EXTRACTS WE STARTED
DEVELOPING SELF-ORGANIZING MAP
TECHNOLOGIES TO LOOK AT THIS,
THIS ALLOWED US TO EVALUATE
ABOUT 1400 COMPOUNDS, PUBLISHED
ON THAT, IN MOLECULAR ONCOLOGY
AND APPENDED WITH DATA ON
SPECIFIC GENETIC SIGNATURE FOR
THE CELL LINES, MUTATIONS,
EXPRESSION LEVELS.
THIS ALLOWED US TO MOVE TO
140,000 RECORDS OF NATURAL
PRODUCT SAMPLES, DEFINE NEW
COMPOUNDS.
THIS FROM SOUTH AFRICA PRODUCED
A NEW CARBON SKELETON THAT
SELECTIVELY TARGETED
OVEREXPRESSING CELLS AND KILLED
THEM.
WITH THAT I'D LIKE TO THANK YOU,
I HOPE I'VE SHOWN SOME NEW
TECHNOLOGIES, METHODS, CHEMICAL
DIVERSITIES AND SOME
PARTNERSHIPS THAT THIS PROGRAM
HAS ENGENDERED AND BIOACTIVE
COMPOUNDS.
IN DISCUSSING WAYS TO BUILD, ONE
WAY I HEARD DR. SHARPLESS
DISCUSS THIS AT A PREVIOUS
MEETING, WITH THE SUBCOMMITTEE,
AND ONE OF THE THINGS WE HAVE
USED SUCCESSFULLY WITH NCATS AND
NCCIH, IGNITE PROGRAM TYPE OF
GRANTING, INNOVATION GRANTS TO
NURTURE TRANSLATIONAL EFFORTS
AND TWO-STEP FUNDING MECHANISM
THAT ENCOURAGES HTS ASSAY
DEVELOPMENT AND SCREENING AND
SHOULD THERE WISH TO BE BUILD
UPON THIS WITH MORE EXTRAMURAL
RESEARCHERS GETTING INVOLVED
WITH SCREENING THIS IS ONE
POTENTIAL AVENUE.
WITH THAT I'D LIKE TO THANK YOU
AGAIN FOR THE OPPORTUNITY TO
HEAR YOUR THOUGHTS AND ADVICE ON
THIS.
AND THANK ALL THE PEOPLE
INVOLVED WITH THE RESERVE.
>> THANKS, BARRY.
THAT WAS A FANTASTIC
PRESENTATION.
WE DO HAVE A FEW MINUTES, FOUR
MINUTES FOR QUESTIONS.
I SEE CHRIS' HAND UP.
>> DR. O'KEEFE, THANK YOU.
JOHN, THANK YOU FOR YOUR
PRESENTATION.
EXCITING WORK.
THANK YOU AND YOUR COLLEAGUES.
I QUESTION THAT HAD COME TO US
EARLIER A LITTLE BIT,
UNDERSTANDING WAS THIS MIGHT BE
SORT OF AN UNDERTAPPED RESOURCE
FOR THE COMMUNITY, AND WANTED TO
THINK ABOUT THAT WITH YOU.
SO THE QUESTION AND SUGGESTION
ARE HAVE YOU TAKEN THIS SLIDE
DECK ON THE ROAD?
IT'S EXTREMELY IMPRESSIVE.
I WOULD IMAGINE A BRIEF
PRESENTATION TO THE CANCER
CENTER DIRECTORS AND/OR THEIR
DEVELOPMENTAL THERAPEUTICS
PROGRAMS ACROSS CENTERS, I WANT
TO SHARE WITH MY D T PROGRAM.
THAT MIGHT HELP FACILITATE MORE
THE TWO-WAY INTERACTION AND EVEN
INCREASE THE ALREADY IMPRESSIVE
BODY OF WORK YOU AND YOUR TEAM
HAVE DONE.
SO THOUGHTS ON DISSEMINATION AND
OUTREACH TO THE NCI CENTERS, OR
OTHER INSTITUTES THAT MIGHT BE
HELPFUL TO YOU IN THIS WORK?
THANK YOU.
>> I MEAN, I WOULD BE HAPPY TO.
NED HAS INVITED ME TO SPEAK.
WITH COVID WE HAVEN'T HAD AS
MANY OPPORTUNITIES TO
DISSEMINATE OVER THE LAST COUPLE
YEARS.
BUT PEOPLE HAD BEEN SEEMING TO
FIND US.
MAYBE WE DIDN'T PUT AS MUCH
IMPETUS AS WE CAN.
VERY GOOD ADVICE AND WE'LL BE
HAPPY TO DO SO.
>> EXPANDING ON THAT, TRYING TO
TURN THIS SOMETHING MORE LAY THE
COMMUNITY WOULD LIKE TO HEAR AS
WELL, HOW NATURAL PRODUCTS ARE
BEING USED AND DEVELOPED FOR
BATTLING CANCER.
I SEE YOUR HAND, WE HAVE AMY AND
WE'LL GO TO YOU, FRANCIS.
>> SEGUEING ON WHAT CHRISTOPHER
COMMENTED ON, YOU'RE USING
NCI-60 AS A HIGH-THROUGHPUT
SCREEN IDENTIFYING COMPOUNDS
WITH DIRECT CANCER EFFECT BUT
THE OTHER AREA, INTERESTED TO
SEE IF YOU MADE COLLABORATIVE
EFFORTS IN THIS PARTICULAR
STRATEGY, HIGH-THROUGHPUT FOR
I-O, THERE'S IMMUNE CHECKPOINT
INHIBITORS, ET CETERA, A LOT OF
TIMES THESE THINGS DON'T
NECESSARILY REVERSE EXHAUSTION,
ET CETERA.
SO YOU COULD CERTAINLY ENVISION
UTILIZING THIS PANEL AND
IDENTIFYING SOME OF YOUR HIGH
CONTENDERS FOR THOSE THAT COULD
POTENTIALLY REVERSE IMMUNE
EXHAUSTION OR INCREASE DIRECT
TUMOR CYTOTOXIC ACTIVITY, ALSO
THROUGH HIGH-THROUGHPUT.
HAS ANYBODY THOUGHT ABOUT DOING
THOSE YET WITH YOU GUYS IN THESE
NATURAL PRODUCTS?
IT WOULD BE QUITE INTERESTING.
>> I MEAN, WE'RE VERY
INTERESTED, WE HAVE SOME
COLLABORATION, I THINK IT'S VERY
IMPORTANT.
MY CURRENT UNDERSTANDING OF THE
MOLECULAR TARGETS ASSOCIATED
WITH IMMUNOLOGIC ONCOLOGY
TARGETS, 70% ARE CYTO STOLIC,
THIS COULD MAKE A BIG
DIFFERENCE.
PART IS GETTING ASSAYS INTO A
HIGH-THROUGHPUT MODE.
SOME ASSAYS PEOPLE APPROACHED US
WITH ARE NOT REALLY AMENABLE TO
384 MUCH LESS 1596 SCREENING,
WE WOULD BE HAPPY TO WORK WITH
PEOPLE WHO COULD DO THAT, AN
UNTAPPED AREA THAT COULD BE
FULLY EXPLOITED.
>> I HAVE AN APC AND T C WITH
EFFECTOR RESPONSE, A CELL WITH
THAT TECHNOLOGY, TO GO THROUGH
ON A SINGLE CELL.
>> TO REDUCE COMPLEXITY OF THE
LIBRARY, ANOTHER OPPORTUNITY
WITH THE I-O.
I WANT TO MAKE SURE FRANCIS HAS
AN OPPORTUNITY TO ASK HIS
QUESTION.
>> THANK YOU VERY MUCH, JOHN.
WE TOUCHED ON ONE OF THE POINTS
I WAS GOING TO BRING UP, IMMUNE
MODULATORS, IMMUNE SYSTEM,
CHECKPOINT INHIBITORS.
I WOULD BE EXTREMELY SURPRISED
IF YOU DIDN'T FIND SOME
IMPORTANT PLANT PRODUCTS THAT
WOULD DO THAT.
BUT IT'S ANOTHER AREA THAT I
THINK PRESENTS WONDERFUL
OPPORTUNITY.
THE CASE OF PREVENTION.
AGAIN, HISTORY OF NATURAL
PRODUCTS HAVE BEEN TO LOOK FOR
KILLING OF TUMOR CELLS, BUT WITH
ADVANCES THAT HAVE BEEN MADE,
ADVANCING IN EARLY CANCER
DETECTION, TARGETS AND SO ON, I
THINK IN ADDITION TO IMMUNE
MODULATORS ANOTHER AREA THAT I
THINK WOULD BE VERY, VERY
REWARDING WOULD BE LOOKING FOR
PLANT AGENTS THAT CAN AFFECT
EARLY STAGES OF CANCER, IT MIGHT
BE ANTIOXIDANTS, THINGS LIKE
THAT.
SO THAT WOULD ALSO REQUIRE JUST
LIKE WITH THE IMMUNE MODULATORS
DEVELOPING NEW SYSTEMS.
SO THIS WOULD REQUIRE
CROSS-DISCIPLINARY
CROSS-EXPERTISE TYPE OF
INITIATIVE.
BUT I THINK THAT'S AN AREA IN
ADDITION TO CHEMOTHERAPEUTICS OR
CYTO TOXICS ALSO TO LOOK AT
EARLY CANCER PREVENTION TYPE
AGENTS.
>> TOWARDS THAT END, A COUPLE
THINGS WE'VE DONE, I WAS AT THE
DIRECTOR OF THE DIVISION OF
CANCER PREVENTION ASKED ME TO
PRESENT TO HIS GROUP ABOUT THIS
INITIATIVE.
AND I DID.
AND THEY ARE INTERESTED IN
ACTUALLY FUNDING POTENTIAL
PEOPLE THROUGH THEIR
ORGANIZATION TO DEVELOP ASSAYS
THAT COULD BE USED WITH THIS
LIBRARY.
IN ADDITION IN THINKING MORE
ABOUT CANCER PREVENTION BECAUSE
THIS IS SOMETHING THAT DR.
SHARPLESS HAS STRESSED AS WELL
AS DR. MASTELLI IN THE CCR WHAT
WE'RE DOING THIS YEAR IS
CONCENTRATING ON PRE-FRACTIONATE
AQUEOUS EXTRACTS, SINCE THEY ARE
NORMALLY WHAT ARE USED FOR
TRADITIONAL HEALING AND SO WE
ARE GOING TO MAKE A LIBRARY OF
THINGS THAT ARE ON THE MEDICINAL
PLANTS AND GENERALLY REGARDED AS
SAFE LIST, THINGS LIKE THAT,
FOODS.
SO WE CAN HAVE THAT AS A
PRE-FRACTIONATED LIBRARY MORE
GERMANE TO CHEMOPREVENTION END
POINTS.
>> THANKS, BARRY.
BLOOD-BRAIN BARRIER IS ANOTHER
AREA.
IT'S TIME TO MOVE ON.
THANK YOU AGAIN.
TO MOVE TO OUR BREAK SO WE CAN
MOVE INTO OUR ADMINISTRATIVE
SESSION.
SO PAULETTE?
DO WE JUST BREAK?
WE WILL RECONVENE.
>> WE WILL RECONVENE AT
APPROXIMATELY -- LET'S SAY 3:30.
>> SO THE BOARD WILL NOW
CONSIDER ONGOING AND NEW
BUSINESS.
AMONG WHICH IS A PRESENTATION OF
ONE OF THE SUBCOMMITTEES.
THERE WAS A MEETING HELD TODAY,
THE CHAIR WILL PROVIDE THE
REPORT.
AND THAT WILL BE DR. FRANCIS
ALI-OSMAN, CHAIR OF THED AD HOC
SUBCOMMITTEE ON GLOBAL CANCER
RESEARCH.
FRANCIS?
>> THANK YOU, JOHN.
WE MET, THE SUBCOMMITTEE ON
GLOBAL CANCER RESEARCH MET A FEW
HOURS AGO.
I HAVEN'T HAD TOO MUCH TIME IN
BETWEEN THAT, IN THE MEETING, TO
GIVE A COMPREHENSIVE REPORT.
THIS WOULD BE A DRAFT REPORT.
WE'LL BE WORKING ON THE FINAL
REPORT WHICH WOULD BE
DISTRIBUTED.
SO, PUTTING TOGETHER MIGHT BE
GOING BACK AND FORTH A LITTLE
BIT.
IT WAS A VERY GOOD MEETING, ONE
HOUR LONG.
AND IT BEGAN WITH WELCOMING THE
NEW MEMBERS FOR THE COMMITTEE,
REMINDING THE SUBCOMMITTEE OF
THE CHARGE.
THE DIRECTOR OF THE CENTER,
PRESENTED A BRIEF UPDATE ON THE
CENTER.
STRATEGIC GOAL OF PLAN OF THE
CGH, REALLY IN THE CONTEXT OF
THE WORLD CANCER DAY WHICH HAD A
TEAM TO CLOSE THE CARE GAP IN
THE WORLD WITH RESPECT TO
CANCER.
WITH PRESIDENT BIDEN LAUNCHING
THE CANCER MOONSHOT AND
COMMITMENT TO GLOBAL HEALTH, THE
FOCUS IS ON LMIC, WITH RESEARCH,
RESEARCH PARTNERSHIP, THE GOAL
TO SUPPORT RESEARCH THAT
ADDRESSES GLOBAL CANCER CONTROL.
IN TRAINING, SUPPORT TRAINING
THAT ENABLE ALSO EQUITABLE AND
IMPACTFUL GLOBAL CANCER
COLLABORATIONS.
AND ALSO WITH BUILDING OF
CAPACITY IN THESE COUNTRIES.
IT'S CRITICAL, ONE OF THE
PILLARS, PROMOTING INTEGRATION
OF CURRENT SCIENTIFIC KNOWLEDGE
INTO GLOBAL CANCER RESEARCH
POLICIES AND CREATE PARTNERSHIPS
AND PROMOTING ENGAGEMENT WITH
KEY GLOBAL PARTNERS.
IT WAS PRESENTED TO US SOME OF
THE UPCOMING EVENTS AND PROGRAMS
AT THE CGH, A NUMBER OF THESE
INCLUDE U01, U 51 GLOBAL
IMPLEMENTATION SCIENCE PROGRAM,
AT LAST MEETING WE HAD -- I
THINK I PRESENTED INITIATIVES,
HIRING OF DR. KRAVITZ, AN EXPERT
IN THAT.
THAT WAS AN EXPANSION OF THE D
43 CANCER TRAINING PROGRAM, AND
SURVEY OF DESIGNATED CANCER
CENTERS, NCI DESIGNATED CANCER
CENTERS, IMPORTANT DISCUSSION
BECAUSE A LOT OF GLOBAL CANCER
RESEARCH WERE GOING ON AT
VARIOUS CANCER CENTERS, THIS HAS
NEVER BEEN COORDINATED AND
LEVERAGE THE BY THE NCI, SO THIS
IS ONE OF THE MAJOR AREAS THAT
WE'LL HEAR MORE ABOUT IT IN
FUTURE REPORTS ON THE CGH.
THEN REPORTED ABOUT THAT ANNUAL
SYMPOSIUM ON THE 10th,
ORGANIZED
THE SUBCOMMITTEE ENCOURAGED THAT
COLLABORATION ACROSS WITH OTHER
STAKEHOLDERS IN THE CANCER
RESEARCH ENTERPRISE.
CONTINUING IN 202 WITH GLOBAL
CANCER RESEARCH AND CONTROL
SEMINAL SERIES.
SO, THE MAIN FOCUS OF THE ONE
HOUR WE HAD WAS ON ONE OF THE
MAJOR PROGRAMS OF THE NCI AND
THAT'S BEEN CHANNELED THROUGH
THE CGH.
AND THAT IS THE AFFORDABLE
TECHNOLOGIES PROGRAM.
ACT.
THIS IS A TRANSDIVISIONAL
PROGRAM MANAGED BY MULTIPLE
DIVISIONS, CENTER FOR GLOBAL
HEALTH, DIVISION OF CANCER
CONTROL AND POPULATION SCIENCES,
DIVISION OF CANCER PREVENTION,
DIVISION OF CANCER TREATMENT AND
DIAGNOSIS, AND THIS IS A TRULY
EXCITING PROGRAM.
DR. PEARLMAN WHO OVERSEES THAT
PROGRAM, PROVIDED OVERVIEW OF
THE ACT PROGRAM.
AND GAVE US SENSE OF WHAT THEY
HAVE BEEN ABLE TO ACCOMPLISH TO
DATE.
TO DATE THEY HAVE SUPPORTED
THREE FUNDING OPPORTUNITIES
THROUGH ANNOUNCEMENT FOAs,
COMPRISED OF SEVEN AWARDS, HALF
OF THESE FUNDED PROJECTS
INVOLVED IN VITRO ASSAYS, A BIT
OF DISCUSSION WHAT IN VITRO
ASSAYS WERE BUT ACTUALLY FOR US
DIAGNOSTIC IN NATURE, COLORECTAL
CANCER, CERVICAL, HPV AND SO ON.
AND THEN THEY HAD SEVERAL
PROJECTS, CANCER TREATMENT, AND
ON PORTABLE IMAGING.
AND THE IN-COUNTRY EXPERIENCES
THEY HAVE HAD LED TO NEW
DEVICES, BETTER SUITED TO LOCAL
ENVIRONMENT.
AND SOME OF THE A.C.T.
TECHNOLOGIES HAVE BEEN EXPANDED
TO OTHER TARGETS.
AND THERE WAS DISCUSSION ABOUT
HOW EFFECTIVE THE PROGRAM HAS
BEEN IN TRANSLATING SOME
TECHNOLOGIES DEVELOPED IN THE
A.C.T., AND IN THIS THEY WORK IN
PART WITH SBIR PROGRAM, WHICH OF
COURSE IS LIMITED.
THEY ALSO HAVE THE CAPACITY,
WORK DIRECTLY WITH THE INDUSTRY
PARTNERS THAT ARE INVOLVED IN
SOME OF THESE GRANTS THAT HAVE
BEEN AWARDED.
THEN WE HAD THE UNIQUE PLEASURE
TO HEAR FROM A NUMBER OF
INDIVIDUALS, ONE WAS THE TITLE
IS PROBABLY -- DR. AGRI SAMIR
FROM -- I THINK INFECTIOUS
DISEASE EXPERT.
AND HE ALSO TREATS KARPOSI
SARCOMA, THE PROBLEM IS IN
ADVANCED COUNTRIES THROUGH
BIOPSIES BUT IN LIMITED
RESOURCES, DIAGNOSIS IS MADE BY
CLINICAL OBSERVATION.
WORKING IN COLLABORATION WITH IN
THE UNITED STATES THEY DEVELOPED
TECHNIQUE, AN INSTRUMENT, TO
TAKE PUNCH BIOPSIES, AND THIS IS
A PCR-BASED INSTRUMENT THAT
WOULD EXTRACT NUCLEIC ACID, DNA
FROM THE PUNCH BIOPSY, ACTUALLY
GIVE A READOUT OF THE AMOUNT OF
VIRUS THAT IS IN THE SAMPLE.
AND VERY -- I THINK ANALYSIS ARE
THEN BEING DONE HERE IN THE
UNITED STATES.
I APOLOGIZE TO PULL THIS ALL
TOGETHER VERY QUICKLY.
BUT ANYWAY, THEY HAVE NOW --
THEY ARE READY TO GO TO THE NEXT
STAGE, AND TEST THIS OUT ON THE
LARGER SCALE.
AND THE -- THERE WE GO.
THEY HAVE IN THREE COUNTRIES
WORKING WITH KENYA AND UGANDA
AND I THINK ZIMBABWE, THE
COLLABORATION THEY HAVE IS WITH
CORNELL UNIVERSITY.
AND DR. ERICKSON, WHO WAS ALSO
PRESENT AT THE PRESENTATION.
AND ADDRESSED SOME OF THE
QUESTIONS WE HAD.
THE NEXT ONE WAS RADIATION
THERAPY PLANNING IN LOW- AND
MIDDLE-INCOME COUNTRIES.
RADIATION THERAPY, MAIN STAY OF
CANCER THERAPY AT LEAST TODAY
REQUIRES SO MUCH EXPERTISE AND
HARD WORK TO CARRY OUT.
AND VERY FEW COUNTRIES IN AFRICA
OTHER THAN SOME SOUTH AFRICA A
FEW COUNTRIES IN NORTH AFRICA
ARE EQUIPPED TO DO IT.
THEY HAVE DEVELOPED THIS -- WHAT
THEY CALL THE RADIATION PLANNING
ASSISTANT TO FACILITATE AND TAKE
AWAY MOST OF THE TASKS THAT CAN
BE DONE WITHOUT HAVING HUMAN
EXPERTISE INVOLVED.
THEY BROUGHT THIS TO THE STAGE
THEY ARE READY TO TEST IN THE
FIELD IN SOUTH AFRICA AS WELL AS
OTHER AFRICAN COUNTRIES.
AND ARE WAITING FOR FDA APPROVAL
IN THE U.S. TO BE ABLE TO TAKE
TO THE NEXT STAGE.
SO, THIS A.C.T. PROGRAM HAS BEEN
SUCCESSFUL AND PRODUCTIVE, AND
THEY HAVE A DIRECTED -- I WOULD
RECOMMEND TO OTHER MEMBERS OF
THE BOARD TO GO TO THE CGH
WEBSITE WHERE THEY HAVE THE LIST
OF OTHER PROJECTS THEY HAVE
FUNDED AND WHERE THEY ARE TODAY.
IT WAS ONE PROJECT THAT WAS
EXCITING, WHICH WAS TO USE GEL
FOAM IMPREGNATED WITH ETHANOL TO
TREAT DYSPLASIA, CERVICAL
DYSPLASIA.
INSTEADING OF CUTTING IT OUT AND
THINGS THAT REQUIRE MORE
EXPERTISE AND INSTRUMENTATION.
THEY JUST INJECT THIS GEL FOAM,
THIS ALCOHOL IMPREGNATION, TO
KILL.
MAY BE POSSIBLE TO DISSEMINATE
IN OTHER RURAL AREAS OF THE
UNITED STATES WHERE CARE IS
SOMEWHAT LIMITED.
IN ONE HOUR, THIS IS ABOUT WHAT
WE'RE ABLE TO ACCOMPLISH.
BUT I THINK WE AGREE AT THE NEXT
MEETING WE'LL HAVE THE MORE
DETAILED UPDATE OF THE OTHER
PROGRAMS IN THE CGH.
WITH THAT I WILL STOP AND TAKE
ANY QUESTIONS.
>> THANK YOU.
PAULETTE, DO WE HAVE TIME FOR
QUESTIONS?
WE MAY HAVE TIME FOR ONE
QUESTION IF THERE'S ANYTHING.
>> OTHER MEMBERS OF THE
SUBCOMMITTEE CAN, YOU KNOW, CHIP
IN AND ADD IF I LEFT A FEW
THINGS OUT.
>> I HAVE A QUICK QUESTION.
FRANCIS, HOW READY FOR USE IN
THE UNITED STATES IS THE
MICROBIOPSY THAT PRINTS OUT THE
DNA, IS THAT SOMETHING THAT
THERE'S A REMOTE PERSON READING
THAT, THAT CAN BE SORT OF
QUICKLY APPLIED?
OR IS THAT SOMETHING ON THE
LONG-TERM HORIZON, YOU KNOW, A
COUPLE YEARS FROM NOW TO --
>> WELL, OKAY.
THEY HAVE THE EQUIPMENT RIGHT
NOW.
THIS SO-CALLED TINY EQUIPMENT.
THAT CAN ACTUALLY GIVE YOU A
READOUT.
IT CAN GIVE A LOAD OF VIRUS
THAT'S IN THE SAMPLE, AND I
THINK NOW IT NEEDS TO BE BETA
TESTED, AND NOT SURE --
SOMETHING LIKE THAT PROBABLY
WOULD HAVE TO GO THROUGH FDA
APPROVAL BEFORE IT WILL GET TO
THE STATES FOR DISSEMINATION,
CERTAINLY IN THE U.S.
NOW, IN THE SOUTH AFRICA,
TREATMENT ASSISTANT, THEY HAVE
GOTTEN I THINK SOUTH AFRICAN FDA
APPROVAL, IT CAN START BEING
TESTED IN THE FIELD OUT THERE.
BUT IN THE U.S. WOULD HAVE TO
WAIT TO GET APPROVAL.
BUT I THINK IT WOULD BE
EXCITING.
I GUESS THIS IS WHERE YOU DRIVE,
THAT IT COULD BE USEFUL LIVING
IN THE U.S. IF IT GETS TO THAT
STAGE BUT I DON'T THINK THEY ARE
THERE YET.
THEY NEED TO BETA TEST AND
POSSIBLY REFINE A FEW FEATURES
OF IT.
>> YEAH, THAT'S GREAT
VALIDATION.
IT WILL BE IMPORTANT.
SO THE NCAB NEEDS TO VOTE TO
ACCEPT THE REPORT THAT WAS
PRESENTED BY DR. ALI-OSMAN.
DO WE HAVE A MOTION TO ACCEPT
THE REPORT?
>> MOTION TO ACCEPT IT.
>> SECOND?
DISCUSSION?
GREAT.
CAN I FIRST SEE HANDS FOR THOSE
WHO VOTE YAY TO ACCEPT?
ANYONE VOTE NAY?
ANYONE ABSTAINING?
>> DID I SEE ONE NAY?
>> NO.
NO, NO.
OKAY.
>> OKAY.
>> THANKS, PAULETTE.
SO, THE YAYS HAVE IT.
YES, PAULETTE?
>> WHILE WE START THE NEXT
MEETING, ASK FOR YAYS, NOT THE
NAYS.
>> GOT IT.
THANK YOU.
>> MY CONNECTION WENT OUT.
I'M SORRY.
I'M NOT SURE WHY.
>> PRIOR TO ADJOURNING THE OPEN
SESSION, ARE THERE ANY OTHER
ISSUES THAT NEED TO BE
ADDRESSED?
IF NOT, WE COULD ALSO TAKE SOME
SUGGESTIONS FOR FUTURE AGENDA
ITEMS, IF SO PLEASE SEND THOSE
TO ME AND PAULETTE.
AND SO THIS CLOSES THE OPEN
SESSION FOR THE FEBRUARY NCAB
MEETING.