>>WISH TO EXPRESS THEIR VIEWS
REGARDING ATTEMPT DISCUSSED
DURING THIS MEETING CAN DO SO BY
WRITING DR. PAULETTE GRAY,
EXECUTIVE SECRETARY OF THE BOARD
WITHIN TEN DAYS FOLLOWING THE
MEETING. ANY WRITTEN STATEMENTS
OF QUESTIONS SUBMITTED BY
MEMBERS OF PUBLIC WILL RECEIVE
CAREFUL CONSIDERATION. TO BOARD
MEMBERS, I WOULD LIKE TO REMIND
YOU THAT YOU MUST ABOUT SENT
YOURSELVES FULLY DURING
DISCUSSIONS WHENEVER YOUR
PARTICIPATION AND DELIBERATIONS
ON A PARTICULAR PRODUCT PROGRAM
OR OTHER SPECIFIC MATTER WOULD
CONSTITUTE A CONFLICT OF
INTEREST OR CREATE THE
APPEARANCE OF ONE. IT IS
INCUMBENT UPON OURSELVES TO
ADVISE THE EXECUTIVE SECRETARY
AND ABSTAIN FROM ANY
PARTICIPATION AND DISCUSSION FOR
ACTION REGARDING THAT MATTER.
IN LIGHT OF THE CURRENT POLICIES
GOVERNING CONFLICT OF INTEREST
BASED ON FINANCIAL HOLDINGS OF
SPECIAL GOVERNMENT EMPLOYEES,
WHICH WE ALL ARE AS BOARD
MEMBERS, WE MUST -- WE HAVE TO
DEPEND ON OURSELVES TO VOLUNTARY
ABSENT DURING ANY AND ALL
DISCUSSION OF MATTERS THAT COULD
CONCEIVABLY IMPACT THE STATUS OF
THOSE HOLDINGS. SO WE HAVE TO
TRUST JUDGMENT IN THESE
INSTANCES DURING ANY CLOSED
SESSION ANY MATERIALS OR
DISCUSSIONS OF THE CONFIDENTIAL
NATURE DELIBERATED ON TODAY ARE
PRIVILEGED INFORMATION AND ARE
MADE AVAILABLE TO YOU ON A NEED
TO KNOW BASIS, SUCH
DELIBERATIONS ARE PRIVATE AND
CONTENT SHOULDN'T BE DIVULGED.
FUTURE MEETINGS, FUTURE MEETING
DATES HAVE BEEN PROVIDED AND ARE
ALSO LISTED ON THE AGENDA. NEXT
WE NEED TO APPROVE THE JUNE 14,
15, 2023 JOINT BSA NCAB VIRTUAL
MEETING SUMMARY. SO CALL A
MOTION TO APPROVE THE MEETING
SUMMARY.
>>APPROVAL.
>>SECOND?
>>SECOND.
>>PROPERLY MOVE AND SECONDED.
ANY FURTHER DISCUSSION? LET'S
VOTE. I'LL ASK ARE THERE ANY
NAYS? ANYONE ABSTAIN? IF NOT,
PAULETTE, I BELIEVE WE HAVE A
UNANIMOUS VOTE.
>>CORRECT. APPROVED.
>>SO QUORUM, BY LAW A QUORUM OF
BOARD MEMBERS IS REQUIRED FOR
EACH INSTANCE IN WHICH A VOTE
MAY OCCUR WHETHER IN OPEN OR
CLOSED SESSION. DURING THIS
MEETING A MINIMUM OF NINE
APPOINTED MEMBERS MUST BE
PRESENT TO VOICE THEIR VOTES.
CAN'T PREDICT TIME NOR
OCCURRENCE OF ANY MOTION, OUR
PRESENCE IN THE VIRTUAL ROOM FOR
ALL SEGMENTS OF THE MEETING IS A
MUST. PAULETTE, DO WE HAVE A
QUORUM?
>>YES, WE DO.
>>THANK YOU. TO ENSURE THERE
AREN'T ANY INTERRUPTIONS AT
TODAY'S MEETINGS, REMAIN MUTED
UNTIL RECOGNIZED BY MYSELF, THE
EXECUTIVE SECRETARY, THE NCI
DIRECTOR OR ONE OF THE SPEAKERS
SO WE WILL NOW MOVE TO OUR
DIRECTORS REPORT. FROM NCI
DIRECTOR DR. MONICA BERTAGNOLLI.
>>THANK YOU, DR. CARPTEN.
LOVELY TO BE WITH Y'ALL TODAY.
LET ME START BY SAYING THAT
TODAY AT NCI WE ARE FACING A
PERIOD OF SIGNIFICANT
UNCERTAINTY ABOUT HOW MUCH
CANCER RESEARCH THE INSTITUTE
WILL BE ABLE TO SUPPORT OVER THE
NEXT YEAR. CONGRESS HAS NOT YET
FINALIZED THE BUDGET FOR FISCAL
YEAR 2024. THAT BEGINS IN
OCTOBER. JUST A FEW WEEKS. SO
RIGHT NOW IT IS UNCLEAR WHAT THE
NEXT YEAR WILL LOOK LIKE FOR OUR
WORK TO ADVANCE PROGRESS AGAINST
CANCER. AS A RESULT WE HAVE
STRUCTURED TODAY'S AGENDA TO
REALLY SPEAK TO THIS SITUATION.
BECAUSE THERE ARE MANY STRONG
SIGNALS THAT THE NEXT TWO YEARS
WILL NOT BE LIKE OTHERS IN THE
PAST AND WE LOOK TO OUR GUIDING
BOARD FOR INPUT INTO HOW BEST TO
MANAGE THIS SITUATION. AFTER MY
INTRO, MK HOLOHAN, DIRECTOR OF
OFFICE OF CONGRESSIONAL AND
GOVERNMENT RELATIONS WILL COVER
THE LATEST LEGISLATIVE
DEVELOPMENTS. AS WE COME TO THIS
FISCAL YEAR'S CLOSE. THE NEXT
DISCUSSION DIRECTOR OF OFFICE OF
BUDGET AND FINANCE TOGETHER WITH
DOUG LOWY, NCI PRINCIPAL DEPUTY
DIRECTOR WILL TALK NCI BUDGET
OPPORTUNITIES AND CHALLENGES IN
LIGHT OF THIS SITUATION. SOME
RECENT HISTORY ON SIMILAR
POLITICAL SITUATIONS AND THEIR
EFFECTS ON NCI FUNDING AND HOW
ARE BUDGET -- OUR BUDGET WORKS.
IT IS A COMPLEX LARGE INSTITUTE
AND THERE ARE INTRICACIES THAT
WILL HELP INFORM YOUR INPUT. WE
WILL LEAVE TIME FOR DISCUSSION
THEN AND MYSELF AND MK, DOUG AND
WES WILL BE AVAILABLE AT THE END
SO TO SET THE STAGE FOR THESE
RECESSIONS FOR THE BENEFIT OF
NEWER BOARD MEMBERS, I THOUGHT I
WOULD FIRST EXPLAIN WHERE WE ARE
IN THE BUDGET PROCESS. NEXT
SLIDE PLEASE. WELL LAST
SEPTEMBER BECAUSE OF SPECIAL
BUDGETARY AUTHORITY WE HAVE NCI
SUBMITTED A FISCAL YEAR 24
PROFESSIONAL JUDGMENT BUDGET
PROPOSAL WHICH IS INTENDED TO
INFORM BOTH THE PRESIDENT'S
BUDGET DEVELOPMENT AND THE
OVERALL APPROPRIATIONS PROCESS.
OUR PROPOSAL PROVIDED THE
OPTIMUM FUNDING FOR SUCCESS IN
24 THAT WE FELT NEEDED TO MAKE
RAPID PROGRESS BASED ON OUR
PROFESSIONAL JUDGMENT.
OPPORTUNITIES ARE TREMENDOUS.
THE SIZE OF OUR OF OUR BUDGET
WAS INCREASED TO BE ABLE TO
ACHIEVE OUR AMBITIOUS GOALS. IN
MARCH THE PRESIDENT SUBMITTED
HIS FISCAL YEAR 24 BUDGET TO
CONGRESS WHICH STARTED THE
APPROPRIATIONS PROCESS. AND IS
BEING CONSIDERED BY CONGRESS AS
THEY NOW DETERMINE NEXT YEAR'S
FISCAL APPROPRIATIONS FOR NCI
AND OTHER AGENCIES AND PROGRAMS
THE PRESIDENT'S BUDGET INCLUDED
A ROBUST INCREASE TO NCI CURRENT
BUDGET. OF COURSE WHEN WE
CONSIDER OUR INVESTMENTS WE ALSO
LOOK TO NEXT YEAR AND WE ARE
OFFERED THE TIME IN AND ARE IN
THE PROCESS WE SUBMIT THE FISCAL
YEAR 25 PROFESSIONAL BUDGET
PROPOSAL WHICH WILL INFORM THE
FISCAL YEAR 25 BUDGET AND SO ON.
THIS FISCAL YEAR 25 REQUEST IS
ALSO IN KEEPING WITH WHAT THE
PRESIDENT PUT FORWARD IN HIS
FISCAL YEAR 24 BUDGET TO
CONGRESS. WHICH AGAIN IS A
GENEROUS INCREASE TO NCI WELL
JUSTIFIED BY THE INCREDIBLE
OPPORTUNITIES WE HAVE BEFORE US
AND THE MORE SIGNIFICANT
PROGRESS WE ARE POISED TO MAKE
FOR THE AMERICAN PEOPLE.
BECAUSE IT IS VERY IMPORTANT THE
AMERICAN PEOPLE SEE THE RETURN
THEY RECEIVE FOR THEIR TAX
DOLLAR INVESTMENT. I WOULD LIKE
TO FOCUS THE REST OF MY REPORT
THIS MORNING ON WHAT OUR RECENT
WORK HAS ACHIEVED AND HOW WE CAN
DO MORE TO MAKE IMPORTANT
PROGRESS AGAINST THE SECOND
LEADING CAUSE OF DEATH IN THE
US. AT THE END OF MY REPORT
WE'LL HAVE TIME FOR QUESTIONS
AND REQUEST THESE FOCUS ON NCI
SCIENCE WHERE WE HAVE PACED OUR
PROGRAMS TODAY, OUR PRIORITIES
AN SAVED THE BUDGET QUESTIONS
FOR AFTER WE HAVE GONE THROUGH
THE THIRD PART OF OUR BUDGET
DISCUSSION. YOU MAY ALL KNOW
DR. WARD MS. CAUSE SKILL
STEVENSES WHO LEADS THE ONCOLOGY
RESEARCH PROGRAM HAS BEEN A
POWERFUL FORCE THROUGH MANY,
MANY YEARS LEADING OUR GOAL TO
BRING CANCER RESEARCH TO THE
COMMUNITIES WHERE PEOPLE LIVE
PARTICULARLY WHO EXPERIENCE
CANCER DISPARITIES. THROUGHOUT
HER CAREER DR. STEVENS HAS HAD
PASSION AND COMMITMENT TO FOLLOW
THE ROAD LESS TRAVEL AND SHE IS
TRULY CHANGED THE TRAJECTORY OF
COMMUNITY CANCER RESEARCH AND
INSPIRED OURS TO FOLLOW IN HER
FOOTSTEPS. IF WE ARE GOING TO
OVERCOME THE MANY CHALLENGES WE
FACE WE NEED TO NURTURE MORE
PEOPLE LIKE DR.
MCCASKILL-STEVENS WHO EMBODY
THIS COMMITMENT. WE CAN'T THINK
OF A BETTER INSPIRATION TO THOSE
WHO WANT TO DO THIS CRITICAL
WORK THAN THE EXAMPLE SET BY
WORTA. TWO WEEKS AGO WE HONORED
HER GREAT WORK BY ANNOUNCING A
NEW CAREER DEVELOPMENT AWARD IN
HER NAME OPPORTUNITY WILL
SUPPORT INSTITUTIONAL CAREER
DEVELOPMENT PROGRAMS, DESIGNED
TO TRAIN CLINICAL SCIENTISTS IN
CLINICAL INTERVENTION AND
TREATMENT RESEARCH. THIS AWARD
WILL BE WIDELY AVAILABLE TO
INDIVIDUALS WHO WISH TO FOLLOW
IN HER FOOTSTEPS. SPECIAL
EMPHASIS HAS BEEN PLACED ON
TRAINING OF CLINICAL SCIENTISTS
WHOSE CAREER GOAL IS TO MEET THE
NEEDS OF UNDERSERVED OR
MARGINALIZED COMMUNITIES FOR
ACCESS TO CLINICAL CARE AND
PATIENT RESEARCH. SINCE WE LAST
MET WE CONTINUE TO BUILD
MOMENTUM FOR THE NATIONAL CANCER
PLAN. WE USING THE PLAN TO HELP
US ALL, EVERYONE FOCUS OUR
EFFORTS TOE REACH THE
PRESIDENT'S CANCER MOON SHOT
GOAL, TO CUT THE AGE ADJUSTED
CANCER MORTALITY RATE IN HALF BY
2047 AND TURN CANCER INTO OF A
LIVABLE TREATABLE DISEASE FOR
ALL PEOPLE. TOMORROW THE
PRESIDENT'S CANCER PANEL WILL
HOLD AN EVENT LED BY DRS.
MITCHELL BURGER, CAROL BROWN AND
LIZ JAFFE TO HOST THE LARGEST
CANCER RELATED ORGANIZATIONS,
EACH OF THESE ORGANIZATIONS WILL
SHARE THE ACTIONS THEY ARE
TAKING TO THE REST OF THE
NATIONAL CANCER PLAN. THE
MEETING IS OPEN TO EVERYONE AND
SO FAR 250 PEOPLE HAVE
REGISTERED TO ATTENDS. THIS IS
JUST TREMENDOUS TO SEE THE
RESPONSE TO PLAN, SO MANY
WILLING TO JOIN IN AND WE ARE
GRATEFUL FOR THE LEADERSHIP OF
THE PRESIDENT'S CANCER PANEL IN
DOING THIS REALLY CRITICAL
ENGAGEMENT WORK. ONE GREAT
EXAMPLE FROM GROUPS ALREADY
SHARING THEIR NATIONAL CANCER
PLAN ACTIONS THIS SUMMER, THE
UNIVERSITY OF COLORADO CANCER
CENTER GETS FIRST IN. POSTED A
SERIES OF STORIES ON THEIR
WEBSITE ABOUT HOW THEY ARE
WORKING TOWARD EACH OF THE
CANCER PLANS EIGHT GOALS. THIS
IS A GREAT EXAMPLE OF HOW REALLY
ANYONE, ANY PARTICIPANT CAN
COMMUNE CASE THE KIND OF WORK
THAT CONTRIBUTES TO THE GOALS
THAT WE SAUL WANT TO SEE
ACCOMPLISHED. THE MORE WE CAN
ALL SEE WHAT OTHERS ARE DOING
THE MORE WE CAN FIND WAYS TO
WORK TOGETHER. ON THE CANCER
MOON SHOT END THE WHITE HOUSE
WILL BE LEADING ANOTHER MEETING
AT THE CANCER CABINET THIS
MONTH. ALL THE CABINET
SECRETARIES PARTICIPATING IN THE
WORK AND GOALS WE ALL SHARE.
THIS MEETING WE WILL CONTINUE TO
COORDINATE WITH -- ACROSS
FEDERAL AGENCIES AS PART OF THE
PRESIDENT'S ALL OF GOVERNMENT
APPROACH TO ENDING CANCER AS WE
KNOW IT AND THERE WILL BE A FACT
SHEET WITH HIGHLIGHTS OF THE
MEETING AFTERWARD. A VERY
EXCITING NEW DATA INITIATIVE IS
PA MOON SHOT COLLABORATION THAT
IS DIRECTLY ALIGNED WITH THE
NATIONAL CANCER PLANS GOALS TO
MAXIMIZE DATA UTILITY, LED BY
MULTIPLE HEALTH FOCUSED
AGENCYINGS, COORDINATED --
AGENCIES COORDINATED THROUGH THE
OFFICE OF SECRETARY OF HEALTH
AND HUMAN SERVICES AN INCLUDES
NCI, CDC FDA, CDC OFFICE OF
NATIONAL COORDINATOR ARPA-H AND
OTHERS. RIGHT NOW WE ARE IN THE
VERY ACTIVE PLANNING STAGES THAT
WILL COORDINATE ACROSS HHS
ACTIVITIES AND THE INITIATIVE
INCLUDES STANDARD DATA FOR
LINKAGES, CROSS HHS ALIGNMENT
FOR STANDARDS AND
INTEROPERABILITY AND BILLING
PARTNERSHIPS BETWEEN THE PUBLIC
-- BUILDING PARTNERSHIPS BETWEEN
PUBLIC AND SECTOR TO POWER
ADOPTION AND DATA SHARING.
ACROSS HEALTH SYSTEMS AND
AGENCIES WE HAVE VALUABLE DATA
RESOURCES. BUT THESE ARE STILL
NOT OPTIMIZED SO THAT WE CAN
TAKE FULL ADVANTAGE OF THE
POTENTIAL TO REVEAL INSIGHTS
THAT WILL PREVENT CANCER AND
MAKE IT LIVABLE AND TREATABLE
FOR ALL PEOPLE. WE NEED
COLLABORATION AT A MASSIVE SCALE
TO LEVERAGE AND CONNECT OUR
RESPECTIVE STRENGTHS AND
RESOURCES. AND THIS INITIATIVE
TRULY HHS WIDE, IS A BIG STEP IN
THAT DIRECTION. LEVERAGING THE
RESOURCES ACROSS THESE AGENCIES
AND IT ALSO PROVIDES A ROADMAP
TO IMPROVE ALL OF HEALTH BEYOND
CANCER. SHIFTING GEARS. WE ARE
DOING EVERYTHING WE CAN TO
ENSURE NCI'S WORK IS ALIGNED
WITH THE NATIONAL CANCER PLAN
GOALS. FOR THE NEXT FEW SLIDES
YOU WILL SEE ON THE RIGHT OUR
ACTIVITIES WORK TOWARD THESE
GOALS. THESE TOKENS IN THE
CORNER INDICATE HOW MANY OF THE
EIGHT GOALS ARE ADDRESSED BY THE
WORK LISTED ON THE SLIDE. THAT
SYNTHESIZES SO MUCH OF WHAT WE
DO CUTS ACROSS THE DIFFERENT
NATIONAL CANCER PLAN GOALS AND
HOW SO THEY ARE NOT SILOED. NONE
OF THESE GOALS ARE SILOED. THEY
DEMAND COLLABORATION FOR
SUCCESS. IN TERMS OF PREVENTION
SCREENING AND EARLY DETECTION IT
IS CRITICAL WE FIND WAYS TO STOP
CANCER BEFORE THEY DEVELOP OR
ALTERNATIVELY WE CAN DETECT
CANCER EARLY ENOUGH TO
SUCCESSFULLY TREAT IT. THIS
YEAR WE LAUNCHED A MAJOR
NATIONAL STUDY WITH CLINICAL
TRIALS TO START IN 2024 TO SEE
WHETHER MULTI-CANCER DETECTION
TESTS IDENTIFY CANCER EARLY
ENOUGH TO REDUCE DEATHS. AND
UNDERSTAND WHETHER THE BENEFITS
OF THESE TESTS CAN OUTWEIGH THE
HARMS. ABILITY TO SCREEN FOR
MANY CANCERS AT ONCE THROUGH A
BLOOD DRAW CAN HAVE PROFOUND
IMPACT ON OUTCOME AND THESE
TESTS CAN POTENTIALLY BOOST
UPTAKE IN SCREENING IF PEOPLE
RECEIVE TEST AS PART OF THE
USUAL VISIT TO THEIR PRIMARY
CARE PHYSICIAN AND YET THERE ARE
TO DATE NO TRIALS THAT SHOW
THESE TESTS TRULY DO REDUCE
CANCER DEATH, AND THAT THE
DOWNSTREAM EFFECT ON HEALTHCARE
SERVICES, AND POTENTIAL FOR
OVERTREATMENT ARE ADDRESSED.
THESE ARE REAL CONCERNS THAT
THIS NEW STUDY WE ARE LAUNCHING
WILL ADDRESS THESE CRITICAL
QUESTIONS ABOUT CANCER SCREENING
INCLUDING EFFICACY,
EFFECTIVENESS, ADOPTION AND
IMPLEMENTATION. YOU SEE OTHER
PROGRAMS LISTED HERE I WON'T
PROVIDE MORE DETAIL ON,
UNDERSTANDING THAT WE HAVE A
ROBUST PORTFOLIO OF WORK MOVING
AHEAD IN PREVENTION SCREENING
AND EARLY DETECTION. NEXT
SLIDE. CLINICAL TRIALS KEY
PRIORITY AREA. WE ARE MAKING A
BIG PUSH TO TRANSFORM OUR
CLINICAL TRIALS SO THEY ACHIEVE
RESULTS FASTER AN BETTER SERVE
EVERYONE, ALL POPULATIONS. TWO
KEY CHALLENGES WE ARE FOCUSING
ON IS HOW TO GET MORE PEOPLE
ACCRUED TO TRIALS PARTICULARLY
THOSE FROM UNDER-REPRESENTED
POPULATIONS. TO STREAMLINE
TRIALS SO THEY ARE MORE COST
EFFECTIVE AND DELIVER RESULTS
FOR EFFICIENTLY. WE NEED TO
BREAK AWAY FROM ROUTINE
PRACTICES THAT NO LONGER SERVE
OUR NEEDS. AND SO WE NEED TO
TEST NEW MODELS THAT CAN
TRANSFORM CLINICAL TRIALS. OUR
NEW CLINICAL TRIALS INNOVATION
UNIT IS HELPING EXPLORE THROUGH
DEVELOPING NEW TRIALS THAT TEST
MODELS AND PUSH US TO WORK
DIFFERENTLY. WE HAVE ALSO
LAUNCHED THE PRAGMATIC LUNG
TRIAL EARLIER THIS YEAR, AN
EARLY EXAMPLE OF APPROACHES THAT
HELP US GET RESULTS FASTER BY
FOCUSING ON OBTAINING ONLY DATA
NEEDED TO DETERMINE IMPACT OF A
COMBINATION OF TREATMENTS ON
SURVIVAL FOR PATIENTS WITH
ADVANCE NON-SMALL CELL LUNG
CANCER AND USING EXTREMELY BROAD
ELIGIBILITY CRITERIA TO HELP
ENGAGE PATIENTS PARTICULARLY
THOSE FROM POPULATIONS TOO OFTEN
LEFT OUT OF TRIALS. THIS WILL
ALSO HELP US COMPLETE ACCRUAL
QUICKLY. WE ARE ALSO BUILDING
WHAT WE HAVE LEARNED THROUGH
SUCCESSFUL NCI PRECISION
MEDICINE TRIAL NCI MATCH BY
LAUNCHING COMBO MATCH, THE
LARGEST INITIATIVE OF ITS KIND
TO TEST COMBINATIONS OF CANCER
DRUGS THAT ARE CHOSEN BASED ON
TUMOR GENOMICS AND OTHER
MOLECULAR CHARACTERISTICS.
UNLIKE NCI MATCH, COMBO MATCH
TRIALS INCLUDE CHILDREN IN THIS
CANCER. MORE INCLUSIVE. SO
IMPORTANT WE CONTINUE TO
STRENGTHEN OUR CLINICAL TRIALS
WORK THROUGH INNOVATION AND
LEARNING AND ENSURE ALL WHO FACE
CANCER HAVE THE OPPORTUNITY TO
PARTICIPATE. AND THAT ALL
POPULATIONS ARE ADEQUATELY
REPRESENTED TO PRODUCE SCIENCE
THAT HELPS EVERYONE. THIS IS A
CRITICAL PRIORITY FOR NCI. NEXT
SLIDE. ANOTHER PRIORITY FOR NCI
IS CLOSING THE GAPS THAT LEAD TO
HIGHER INCIDENCE IN MORTALITY
FOR SOME POPULATIONS
PARTICULARLY THOSE WHO LONG
FACED SYSTEMIC BARRIERS TO
RESEARCH AND CARE. WE HAVE
LAUNCHED A NUMBER OF NEW
PROGRAMS OVER THE LAST FEW YEARS
TO PUSH OUR DISPARITIES RESEARCH
INTO NEW AREAS AS WE HAVE COME
TO BETTER UNDERSTAND THE GAPS
THAT EXIST. THIS YEAR WE
LAUNCHED THE FIRST INITIATIVE TO
STUDY HOW PERSISTENT POVERTY
LEAD TO WORSE CANCER OUTCOME
CONSIST AND HOW TO OVERCOME
THESE BARRIERS. RESEARCH HAS
SHOWN CANCER DEATH RATES ARE
HIGHER IN AREAS WITH PERSISTENT
POVERTY IN THE U.S. WE KNOW OUT
EFFECTIVE INTERVENTIONS,
PERSISTENT POVERTY WILL LIKELY
CONTINUE TO EXACERBATE HEALTH
DISPARITIES IN CARIS AND IN
OTHER DISEASE -- CANCER AND
OTHER DISEASES. WE ARE STUDYING
HOW TO IMPROVE REPRESENTATION IN
CLINICAL TRIALS, HOW TELEHEALTH
CAN MAKE IT EASIER FOR PEOPLE TO
ACCESS CANCER CARE AND
PARTICIPATE IN TRIALS AND HOW IT
CAN OVERCOME OR PERHAPS IF NOT
USE WELL EVEN EXACERBATE CANCER
HEALTH INEQUITIES. SOMETHING
THAT SETS NCI APART IS HOW TO
BUILD THE FUTURE OF CANCER
RESEARCH THROUGH OUR INVESTMENTS
IN PEOPLE AN ESSENTIAL
INFRASTRUCTURE THAT MAKE IT
POSSIBLE FOR MUCH OF THE
PROGRESS THAT OUR PATIENTS NEED
WE PROVIDE CRITICAL
OPPORTUNITIES TO STRENGTHEN THE
WORK FORCE TO BRING THE WIDEST
POSSIBLE VARIETY OF IDEAS AND
PERSPECTIVES TO DELIVER THE BEST
CANCER SCIENCE. THAT INCLUDES
NEWER PROGRAMS TO FUNDS AND
MENTOR SCIENTIST BACKGROUND TO
BUILD A PIPELINE OF TALENTED
CANCER RESEARCHERS WE NEED
DESPERATELY TO MEET TODAY'S
OPPORTUNITIES. DIVERSITY AMONG
OUR SCIENTISTS IS VITAL TO
ASKING THE RIGHT RESEARCH
QUESTIOQUESTIONS. AND UNDERSTANE
CHALLENGES FACED BY ALL
POPULATIONS. IN PARTICULAR I
WILL SPOTLIGHT ONE OF THESE NEW
PROGRAMS THE CANCER MOON SHOT
SCHOLAR, DESIGNED WITH GOAL TO
ADVANCE OUR SCIENCE THROUGH
GREATER DIVERSITY IN OUR RO1
APPLICANT POOL. THIS IS
IMPORTANT BECAUSE RO1s ARE THE
SOURCE OF SO MANY OF THE
INNOVATIVE IDEAS AND SOME OF THE
MOST SIGNIFICANT DISCOVERIES IN
CANCER RESEARCH WHO JUST
ANNOUNCED OUR FIRST COHORT OF
SCHOLARS. HERE THEY ARE. AS YOU
CAN SEE, FROM THIS LIST OF
RECENT PROJECTS, THE PROGRAM
ALREADY COVERS QUITE A RANGE OF
CANCER TYPES, SPANS IMPORTANT
DISCIPLINES IN SCIENCE FROM
BASIC TO TREATMENT TO
IMPLEMENTATION SCIENCE RESEARCH
ANOTHER INVESTMENT WE MADE IS IN
CANCER DATA AND TECHNOLOGY.
THESE ARE TRANSFORMING WHAT IS
POSSIBLE FOR CANCER RESEARCH AND
INCLUDES BUILDING INFRASTRUCTURE
THAT CONNECTS VAST COLLECTIONS
OF DATA TO POWER MORE ROBUST
ANALYSIS AND CREATE 3-D TUMOR
ATLASES MAKING IT POSSIBLE TO
DETECT HOW CANCER EVOLVE
PRE-CANCEROUS LESIONS TO ADVANCE
DISEASE. THESE RESOURCES ARE
VALUABLE AS THE QUANTITY AND
QUALITY OF THE DATA THAT IS WHY
WE NEED TO INVEST IN COLLECT
COLLECTING ENOUGH DATA FROM ALL
POPULATIONS TO WORK FOR EACH. TO
DO SO IT IS ESSENTIAL THAT
PEOPLE WITH CANCER OR LISTK RISK
OF DISEASE HAVE THE CHANCE TO
CONTRIBUTE. SO THIS IS A FOCUS
OF ALL OF OUR DATA COLLECTION
ACTIVITIES. THIS GIVES US THE
POTENTIAL TO LEARN FROM EVERY
PATIENT AND IMPROVE RESULTS FOR
EVERYONE. THE CHILDHOOD CANCER
DATA INITIATIVE IN PARTICULAR
HAS MADE TREMENDOUS PROGRESS IN
A FEW YEARS, TO MAKE ACCESSIBLE
DATA HISTORICALLY CHALLENGING
FOR RESEARCHERS TO ACCESS
BECAUSE OF HOW RARE CHILDHOOD
CANCER CAN BE AND BECAUSE THIS
DATA ARE OFTEN STORED IN
HOSPITALS WHERE IT CAN BE HARD
TO REACH. NOT ONLY DOES CCDI
HELP RESEARCHERS STUDY THESE
RARE CANCER, ITS USE WILL HELP
ONCOLOGISTS AND PATIENTS MAKE
THE BEST POSSIBLE TREATMENT
DECISIONS. AMONG CCDIs RECENT
DEVELOPMENTS IS IT FACILITATED
THE RELEASE OF A SIGNIFICANT NEW
SOURCE OF PEDIATRIC BRAIN TUMOR
CHARACTERIZATION AND CLINICAL
DATA FROM THE CHILDREN'S BRAIN
TUMOR NETWORK. THE PACIFIC
PEDIATRIC NEURAL ONCOLOGY
CONSORTIUM AND THE CHILDREN'S
HOSPITAL OF PHILADELPHIA. I CALL
YOUR ATTENTION TO THIS
PARTICULAR INITIATIVE LAUNCHED
AS A DATA SHARING INITIATIVE
WHICH IS NOW BECOME A COMMUNITY
FOCUS FOR RESEARCH DIRECTED AT
OVERCOMING PEDIATRIC CANCERS.
OF COURSE WHAT ULTIMATELY
MATTERS IS WHETHER WE DELIVER
SCIENTIFIC RESULTS THAT MOVE US
TOWARD REAL PROGRESS. THIS IS
JUST A LIST OF SO MANY EXAMPLES
OVER THE PAST YEAR THAT HAVE
BEEN SELECTED TO SHOW NCI
SUPPORT HOW NCI SUPPORT OF
SCIENCE HAS PAID OFF WITH MANY
SIGNIFICANT ADVANCES. WE WON'T
ACHIEVE SCIENTIFIC PROGRESS THAT
TRULY ADDRESSES THE NEEDS OF ALL
WHO HAVE CANCER OR AT RISK OF
DISEASE WITHOUT THE FOUNDATIONAL
UNDERSTANDING THAT COMES FROM
BASIC SCIENCE. BECAUSE OF SOME
OF OUR BASIC SCIENCE ADVANCES
THIS YEAR, WE BETTER UNDERSTAND
WHAT FUELS THE GROWTH OF
PANCREATIC CANCER HOW COLON
CANCER METASTASIZES AND WHAT
TRIGGERS THE FORMATION AND
PROGRESSION OF ESOPHAGEAL
CANCECANCER. A NUMBER OF STUDIEU
SEE HERE BRING BENEFIT TO THOSE
WHO ARE WORKING TO PREVENT AND
TREAT CANCER. AN EXAMPLE OF THE
IMPLEMENTATION SCIENCE END WE
FOUND THROUGH ONE OF OUR CANCER
MOON SHOT FUNDED PROGRAMS THAT
CLINICIAN FOCUSED NUDGES USING
ELECTRONIC HEALTH RECORDS CAN
RESULT IN MORE CANCER PATIENTS
ENGAGING IN TOBACCO USE
TREATMENT. FROM RESEARCH ON
CANCER SURVIVORS WE HAVE A
BETTER UNDERSTANDING OF
ASSOCIATION OF METABOLIC
SYNDROME IN CANCER SURVIVORS BY
GENDER. THE STUDY ALSO FOUND MEN
WITH HISTORY OF HEMATOLOGIC
MALIGNANCIES AND WOMEN WITH
CERVICAL CANCER WERE GREATEST
RISK OF DEVELOPING METABOLIC
SYNDROME. WHILE NCI SCIENCE LED
TO TREATMENT POSSIBILITIES THIS
YEAR I ALSO LIKE TO JUST
SPOTLIGHT THIS ADVANCE IN
PARTICULAR. NCI CLINICAL TRIAL
CONDUCTED AT THE CLINICAL CENTER
ON THE NIH CAMPUS LED TO
APPROVAL TO TREAT ADULTS AN
CHILDREN TWO YEARS AND OLDER FOR
THE RARE CANCER ADVANCED
ALVEOLAR SARCOMA. I HIGHLIGHT
THIS BECAUSE OUR GOAL IS TO ENDS
CANCER AS WE KNOW IT FOR ALL
PEOPLE. AND THIS EXAMPLE SHOWS
WHAT I THINK ARE REALLY
IMPORTANT UNIQUE CONTRIBUTIONS
OF NCI RESEARCH. RESEARCH FUNDED
BY THE AMERICAN PEOPLE CAN FOCUS
ON RARE CANCER. UNDERSTUDIED
WITHIN THE CANCER RESEARCH
COMMUNITY OVERALL FOR A VARIETY
OF REASONS. A BIG REASON WE CAN
AS THE QUOTE FROM DR. DOROSHOW
IN THE BOTTOM RIGHT NOTES ABOUT
THIS TRIAL, THAT THE NCI
CLINICAL CENTER MAKES IT
POSSIBLE -- NIH CLINICAL CENTER
MAKES IT POSSIBLE TO BRING IN
PATIENTS FROM ALL OVER THE WORLD
FOR DEDICATE STUDIES ON RARE
CANCER, THE ONLY WAY TO MAKE
PROGRESS QUICKLY. YOU WILL HEAR
MORE ABOUT THE WORK TO CONQUER
RAREST OF CANCERS IN TODAY'S
MEETING IN OUR SCIENTIFIC
PRESENTATION. SO LOOKING
FORWARD, WHEN YOU LOOK ACROSS
THE AREAS I FOCUSED ON TODAY YOU
WILL SEE NCI PUT KEY PLACES INTO
PLACE PIECES INTO PLACE TO
ADDRESS SCIENTIFIC CHALLENGES WE
FACE. WE CAN'T LAUNCH THIS
PROGRAM, BUILD THE
INFRASTRUCTURE NEEDED FOR ALL,
AND THEN JUST WALK AWAY. CCBI
FOR EXAMPLE STARTED MODESTLY.
AND NOW LOOK WHAT IT IS DOING TO
TRULY GALVANIZE THE ENTIRE
PEDIATRIC CANCER COMMUNITY. IT
IS GROWN SO MUCH AND IS TRULY
CHANGING WHAT IS POSSIBLE FOR
(INAUDIBLE). WE CAN DO MUCH MORE
OF THIS. FOR EVERYONE. SOME OF
OUR PROGRAMS ARE STILL GETTING
OFF THE GROUND BUT WILL PAY BIG
DIVIDENDS DOWN THE ROAD. WE
NEED TO SUSTAIN THEM. WE ALSO
NEED TO PUSH INTO OTHER AREAS,
CONSISTENT WITH MEETING THE
GOALS OF THE NATIONAL CANCER
PLAN. WE WOULD LOVE TO BE ABLE
TO LAUNCH MORE COMPREHENSIVE
SYSTEMS BIOLOGY WORK FOR
INSTANCE. THROUGH SUCCESS IN
COMMUNITY OUTREACH AND
ENGAGEMENT WORK THROUGH CANCER
CENTERS WE CAN DO SO MUCH MORE
FOR THE UNDERSERVED. WE WOULD
LIKE TO EXPAND SUCCESSFUL
APPROACHES, CONSIDERABLY, WITH A
FOCUS ON PARTICULAR CANCER
CENTERS THAT EXCEL IN CARING FOR
UNDERSERVED POPULATIONS. WE
HAVE A NEW SCREENING NETWORK AND
WOULD LIKE TO ROLL OUT THE
MOLECULAR -- MULTI-CANCER
DETECTION PROGRAM IN A BIG WAY.
SO DEMONSTRATE A BENEFIT TO
CANCER SURVIVAL. WE NEED TO
SIGNIFICANTLY INCREASE ACCRUAL
TO CLINICAL TRIALS AND BEYOND,
INNOVATING IN HOW WE CONDUCT
THEM. WE ALSO REALLY NEED MORE
TRIALS. THE PRIVATE INDUSTRY
COMMUNITY WILL NOT ADDRESS EVERY
QUESTION OUR CANCER PATIENTS
NEED. THERE'S STILL SO MUCH MORE
WE NEED TO DO TO UNDERSTAND
ABOUT CANCER BIOLOGY TO IDENTIFY
POTENTIAL APPROACH AGAINST
CANCER, FOR EXAMPLE WHICH WE
STILL DON'T HAVE SUFFICIENT
UNDERSTANDING OR SOLUTIONS.
ANOTHER CRITICAL FOCUS IS TO
SUPPORTS RESEARCH PROJECT
GRANTS. WE MUST CONTINUE TO
RAISE OUR PAY LINES AS WE DID
THIS YEAR, SO THAT WE AREN'T
FORCED TO LEAVE GREAT IDEAS FROM
OUR NATION OF SCIENTIFIC TALENT
ON THE TABLE. TO DO ALL OF THIS
WILL TAKE SIGNIFICANTLY MORE
FUNDING: AS I SAID AT THE TOP
DISCUSSION THIS MONTH WE WILL
RELEASE OUR FISCAL YEAR 25
PROFESSIONAL JUDGMENT BUDGET.
>>NEXT SLIDE. WHEN YOU LOOK AT
ALL I HAVE HIGHLIGHTED TODAY YOU
CAN SEE THAT NCI IS FULLY
COMMITTED TO DOING EVERYTHING WE
CAN TO POWER CANCER RESEARCH
ACROSS THE FULL SPECTRUM FROM
BASIC DISCOVERY OF CANCER
BIOLOGY TO UNDERSTANDING HOW TO
DELIVER THE VERY BEST HEALTHCARE
FOR ALL WHO NEED IT. WE ALL
KNOW THERE IS STILL SO MUCH TO
DO TO ACCOMPLISH OUR ULTIMATE
GOAL AGAINST THIS AWFUL DISEASE.
I KNOW WE CAN SUCCEED, WE CAN
EXPAND ON SO MANY SUCCESSES IN
THE RECENT PAST BUT THAT WILL
TAKE ACTION AT ALL LEVELS OF
SOCIETY AND THAT ACTION STARTS
WITH RESEARCH TO SHOW THE WAY
FORWARD WHICH IS THE PRIMARY
ROLE OF NCI. SO ON THAT NOTE I
WOULD LIKE TO STOP HERE. I HOPE
WE HAVE A FEW MINUTES TO OPEN UP
TO YOUR QUESTIONS. THANK YOU.
DR. CARPTEN.
>>THANKS, MONICA. BOARD MEMBERS
PLEASE FEEL FREE TO DONE YOUR --
TURN YOUR CAMERAS ON. WOULD LOVE
TO HEAR MORE ABOUT ADVANCES ON
THE MOON SHOT PARTICULARLY THE
CONCEPT OF THE CANCER CABINET.
WHICH WAS THIS CONCEPT OF
BRINGING TO BEAR THE BROADER
ARMAMENTARIUM OF THE GOVERNMENT
TOWARDS OTHER CANCER MOON SHOT.
CAN YOU GIVE SOME EXAMPLES OR
GIVE LATE INSIGHT SOMEHOW THE
CANCER CABINET IS WORKING WITH
NCI AND NIH AND HOW THAT IS
ADVANCING?
>>THE FIRST I WILL JUST SAY THE
FIRST BIG SUCCESS I'M THRILLED
ACROSS HHS DATA DATA
INTEGRATION. IF YOU CAN IMAGINE
FOR THE FIRST TIME WE ARE GOING
TO BE ABLE TO BRING TO BARE DATA
COLLECTED BY CDC, CMS, FDA,
ACROSS NIH, WE HAVE MANY
PARTNERS AT NIH ALSO THAT ALSO
CAN DELIVER DATA ESSENTIAL FOR
THE CANCER SPACE COORDINATED
THROUGH THE OFFICE OF NATIONAL
COORDINATORS SO THAT WE HAVE
EVERYTHING WE CAN COMPARE APPLES
TO APPLES AND ACHIEVE THE SCALE
WE WANT TO SEE. SO FIRST OF ALL
WITHIN OUR OWN AGENCY OF THE
FEDERAL GOVERNMENT THIS IS A
BIG, BIG PROGRESS. THAT IS GOING
TO BE PRESENTED TO THE CANCER
CABINET TODAY AS AN EXAMPLE OF
WHAT ONE AGENCY CAN DO. THERE
ARE MANY OTHER CROSS AGENCIES
COLLABORATIONS. I KNOW YOU ARE
AWARE, DEPARTMENT OF DEFENSE,
ENVIRONMENTAL PROTECTION AGENCY.
EVEN FEMA BELIEVE IT OR NOT. WE
KNOW THESE EXAMPLES THAT P
HAPPENED IN THE PAST. AND THE
CABINET IS JUST AN OPPORTUNITY
TO GET THE SECRETARIES TOGETHER
TO FINALIZE PLANS GOING FORWARD
I'M REALLY LOOKING FORWARD TO
SEEING WHAT THE LATEST CABINET
MEETING PRESENTS. THIS IS ONLY
THE SECOND WE HAVE HAD THIS
YEAR. AND YOU WILL SEE THAT IN
THE FACT SHEET.
>>GREAT. THANKS, MONICA. ANNA,
I SEE YOUR HAND UP.
>>YES. THANK YOU SO MUCH. MY
QUESTION WAS RELATED TO THE HHS
CANCER MOON SHOT. I WAS THINKING
ABOUT ALL THE DATA OUTSIDE OF
HHS THAT YOU MENTIONED. I WAS
THINKING THE EPA DAT DATA. USDS,
OTHER AGENCIES THAT HAVE
IMPORTANT ENVIRONMENTAL DATA
IMPORTANT FOR CANCER. SO I DON'T
KNOW IF YOU MENTIONED, I BELIEVE
I UNDERSTAND THOSE WERE EFFORTS
FROM THE PAST. I DON'T KNOW IF
YOU ARE THINKING ALSO IN
BRINGING THESE EFFORTS TOGETHER
HHS IS TOO AMBITIOUS BUT BE
CURIOUS TO KNOW IF THERE IS ANY
CONVERSATION ALREADY GOING ON.
>>THANK YOU FOR THAT QUESTION.
SO IN ANYTHING THAT IS BIG YOU
HAVE TO HAVE PRIORITIES. OUR
FIRST PRIORITY WHICH IS
INCREDIBLY AMBITIOUS IN ITSELF
IS DATA FROM THE CLINICAL CARE
ENVIRONMENT. WE ARE LOOKING THIS
IS WHY CMS, CDC, OF HHS, VA. WE
WANT VA PARTNER PARTNERS. WE WO
BRING WHAT IS HAPPENING TO
PEOPLE OUT THERE IN TO OUR DATA
STREAMS AND WE FEEL HHS IS THE
BEST PLACE TO START WITH THAT.
SO THAT IS ONE OF THE BIG
INITIATIVES. THEN SECONDARILY,
LOT OF THESE OTHER DATA SETS,
THERE IS A WHOLE ARM WHICH IS IN
COLLABORATION WITH THE ARPA-H
ANNOUNCEMENT IS TO BRING
TOGETHER A FEDERATED ENVIRONMENT
TO ALLOW US TO PULL IN DATA FROM
EPA AND OTHER RESOURCES YOU ARE
LOOKING AT. WITH THE FEDERATED
GOVERNANCE SYSTEM. THE LAST
THING I WILL SAY, WE DONE HAVE
TIME BUT ONE FEATURE I WANT
EVERYONE TO KNOW ABOUT IS THIS
DATA CLINICAL CARE ENVIRONMENT
HAS THE MANDATE WE DEVELOP A WAY
EVERY INDIVIDUAL PATIENT KNOWS
-- HAS GIVEN PERMISSION FOR
THEIR DATA TO BE USED AND KNOWS
WHAT WE ARE DOING WITH THEIR
DATA. WE ARE COMMITTED TO THAT,
THAT IS THE REALLY HEAVY LIFT WE
CHOSE, TO MAKE IT DOWN TO THE
INDIVIDUAL PERSON TOE GIVE
PERMISSION AND KNOW WHAT THEIR
PARTICIPATION IS.
>>THANKS. IF YOU HAVE A
QUESTION PLEASE USE THE RAISE
YOUR HAND TOOL.
>>HOW ARE WE ON TIME?
>>WE HAVE AT LEAST FIVE
MINUTES. SO WE HAVE TIME FOR
ADDITIONAL QUESTIONS.
>>THIS IS AN OPEN SESSION SO
YOU CAN ALSO USE THE CHAT.
>>THANKS, PAW LEGAL. YOU CAN
USE THE CHAT. T ANN BARKER. YOU
ARE MUTED, ANN.
>>SO THANK YOU, MONICA. THAT
WAS REALLY INSPIRING. I WANTED
TO ADDRESS SOMETHING YOU JUST
MENTIONED THAT I THINK IS A
REMARKABLE SET OF NEW
INITIATIVES WITH ARPA-H. I THINK
WE ARE ALL WONDERING ABOUT THIS
BEING PART OF THIS OVERALL PLAN
TO LEARN MORE ABOUT CANCER BUT
IT IS REALLY COMING INTO FOCUS
NOW. THE DATA INITIATIVE IT IS
REMARKABLE. I JUST ATTENDED A
MEETING WEEK BEFORE LAST, AN
ARPA-NCI COORDINATED EFFORT OVER
TIME TO CREATE NEW CLINICAL
TRIAL DESIGNS SO I THINK THIS IS
-- I WONDER IF YOU CAN SAY MORE
ABOUT THE COLLABORATION THERE
AND HOW YOU SEE THAT PAYING OFF
IN TERMS OF BEING ABLE TO SCALE
SOME OF THE THINGS WE DO AS
WELL.
>>IT IS BEEN A GREAT
PARTNERSHIP. THAT IS THE WAY TO
VIEW IT. THEY HAVE A DIFFERENT
MODEL FOR HOW THEY VIEW
RESEARCH. I THINK Y'ALL HEARD ME
SAY THIS BEFORE, NCI TAKE IT IS
LONG VIEW. WE WANT TO GO ALL THE
WAY FROM THE MOLECULAR DISCOVERY
TO WHAT HAPPENED IN A PATIENT.
AND WE OWN EVERY BIT OF THAT
PATHWAY. WHEREAS ARPA H TAKES
THE, WE WANT TO RUN IN AND SOLVE
CRITICAL PROBLEMS FOCUS, BE
NIMBLE SOLVE CRITICAL PROBLEMS
AND MOVE TO THE NEXT. SO IT IS
INCREDIBLY COMPLIMENTARY WHAT WE
ARE DOING AND I THINK YOU ARE
GOING TO SEE THAT PLAYED OUT IN
THE DATA SPACE BECAUSE WE HAVE A
LOT OF CRITICAL PROBLEMS THAT IF
WE CAN JUST GET ONE PIECE OF THE
PUZZLE INTENSELY FOCUSED ON THAT
WILL HELP US WITH OUR
LONGITUDINAL PLANS IN A GREAT
WAY. SO YOU ARE SEEING SOME OF
THAT AND THEY WILL HAVE AN
ANNOUNCEMENT SOON ABOUT OUR BIG
COLLABORATION IN THE DATA SPACE
OR ONE. THERE'S MORE THAN ONE.
>>SORT OF SPEAKS TO LEVERAGE.
IN THESE TIMES IT IS ALWAYS
GREAT TO PARTNER AND LEVERAGE
ACROSS. I GUESS THAT SORT OF
BRINGS UP THE OLD CONVERSATIONS
ABOUT PUBLIC PRIVATE
PARTNERSHIPS. WHAT IS NCI DOING
TO SORT OF REACH OUT TO THE
INDUSTRY BIOTECH COMMUNITY, ARE
THERE OPPORTUNITIES THERE YOU
WOULD LIKE TO PROVIDE SOME
INSIGHTS AROUND?
>>THERE IS MANY DIFFERENT WAYS
THAT WE INTERSECT WITH THE
PRIVATE FOR PROFIT COMMUNITY.
FIRST WE HAVE OUR SBIR PROGRAM
WHICH WE JUST HAD A DEEP DIVE
INTO YESTERDAY. I JUST HAVE TO
TELL YOU ANYONE WHO IS
INTERESTED TAKE A LOOK. OR GO TO
THE WEBSITE. IT IS REALLY
INCREDIBLY HEALTHY ACTIVE
PROGRAM BRIDGING THE GAP,
BRINGING NEW TECHNOLOGIES NEW
THERAPEUTICS TO
COMMERCIALIZATION WHICH IS
EXCITING. I THINK THERE ARE MANY
OTHER PLACES NATIONAL CLINICAL
TRIALS NETWORK, ALL OUR CLINICAL
TRIALS WORK IS AN EXAMPLE
THROUGH THE CREDA SYSTEM TO
OBTAIN DRUGS DESIZES AND OTHER
ABSOLUTELY NEEDED RESOURCES IN
ORDER TO CONDUCT RESEARCH. THEN
I THINK WE ARE STARTING TO SEE
IT CLEARLY IN THE DATA SYSTEMS
AND DATA SCIENCE WORK AS WELL,
THIS IS A LITTLE NEWER BUT THE
ROAD MAP IS QUITE THERE FOR
INTERACTION WITH INDUSTRY IN
ALMOST ANYTHING WE DO AND WE ARE
STARTING TO SEE IT BRING TO BARE
IN THE DATA SCIENCE WORLD AS
WELL.
>>GREAT. THANKS, MONICA. ARE
THERE ANY ADDITIONAL QUESTIONS
FOR DR. BERTAGNOLLI BEFORE WE
MOVE ON? YOU ARE MUTED.
>>SO SORRY. DR. BERTAGNOLLI,
ONE OF THE THINGS THAT HAS COME
OUT IN A VERY PUBLIC WAY IS THE
WHOLE ISSUE AROUND AI. IN WHAT
WAY -- I KNOW IT IS A HUGE
SUBJECT BUT WHAT WAY WILL YOU
TRY TO CREATE SOME EDUCATIONAL
MATERIALS FOR THE PUBLIC TO
UNDERSTAND THE CONVERGENCE OF AI
WITH SCIENCE AND NOT FEAR IT,
NOT MISUNDERSTAND IT, BECAUSE
THIS IS A HUGE ISSUE THAT I
ALREADY SEE IN THE PUBLIC ARENA
WHICH I'M WORKING ON SIDEWAY
PROJECTS. LIKE TO KNOW WHERE NCI
IS GOING TO ENTER INTEGRATE AND
INTERVENE TO MAKE SURE ONCE
AGAIN THE PUBLIC UNDERSTANDS IT
AND DOESN'T FEAR IT?
>>OH, YEAH, THIS FITS TO THE
CATEGORY OF SO MANY THINGS IN
SCIENCE THAT ARE NEW. SO MACHINE
LEARNING IS A NEW WAY OF
ANALYZING DATA THAT CAN PRODUCE
INSIGHTS THAT AREN'T IMMEDIATELY
OBVIOUS AND CAN TAKE LARGE DATA
COLLECTIONS TO DO SO. THERE ARE
MANY OTHER USES BUT THAT IS THE
USE WE PRIMARILY DO IN THE
RESEARCH COMMUNITY. I THINK THAT
US BEING VERY EFFECTIVE
COMMUNICATORS WITH PEOPLE IS ONE
OF OUR CRITICAL JOBS. AI IS AN
EXAMPLE WE CAN DO, I THINK THE
BEST WE CAN DO IS EXPLAIN
EXACTLY WHY WE USE THESE NEW
TECHNIQUES WHAT THE NEW
TECHNIQUES PRODUCE FOR THEM.
WHAT THE IMPACT OF NEW
TECHNIQUES MIGHT BE ON THE NEW
TREATMENT OR NEW APPROACHES THEY
MAY SEE FROM THEIR PHYSICIANS IN
CLINIC. SO COMMUNICATING THOSE
THAT THE TOPIC OF AI IS TOO BIG,
WE NEED TO GET DOWN TO SPECIFICS
FOR PEOPLE, ONE BY ONE AND
EXPLAIN HOW THESE NEW DISCOVERY
TOOLS ARE BEING USED. LAST OF
ALL, I ALSO THINK IT IS
ABSOLUTELY CRITICAL. I REINFORCE
AGAIN THAT PEOPLE UNDERSTAND IF
WE DO RESEARCH WITH PEOPLE WE
ENGAGE PEOPLE. YOU HAVE TO DO
THAT IN A MANNER OF TRUST AND
BIDIRECTIONAL COMMUNICATION
WHICH IS WHAT YOU ARE TALKING
ABOUT HERE. I THINK WE ARE GOING
TO SEE MORE AND MORE FOCUS ON
THAT BECAUSE IT IS CERTAINLY ONE
OF MY PERSONAL HIGH PRIORITIES I
KNOW FOR NCI. NOT JUST AI BUT
REALLY EVERYTHING WE DO. WE
SHOULD HAVE BLACK BOXES FOR
PATIENTS AND OUR PEOPLE. THEY
NEED TO KNOW WHAT WE ARE DOING.
LOOK AT WHAT WE ARE EVEN
OFFERING TODAY. THERE IS QUITE A
BIT THERE, THERE'S OPPORTUNITIES
FOR INTERACTION. CHECK OUT ALL
THE WEB SITES AVAILABLE, YOU
WILL BE SURPRISED HOW MUCH IS
ALREADY THERE.
>>IN THE INTEREST OF TIME WE
WILL MOVE ON TO OUR NEXT
PRESENTATION. IF YOU HAVE A
QUESTION OR COMMENT PLEASE TYPE
INTO THE CHAT, I THINK EVERYONE
WOULD LOVE TO HEAR FROM YOU.
NEXT WE HAVE MK HOLOHAN WHO WILL
GIVE US THE LEGISLATIVE REPORT.
>>THANK YOU, DR. CARPTEN. THANK
YOU FOR THE OPPORTUNITY TO SPEAK
WITH THE BOARD TODAY. AS ALWAYS
I'M GOING TO REMIND YOU THERE IS
A DETAILED LEGISLATIVE UPDATE IN
YOU ARE YOU MATERIALS AND THAT
MY TEAM ARE PAP PI TO TALK WITH
YOU AND/OR YOUR STAFF ANY TIME
SO REACH OUT IF THERE'S ISSUES
YOU WOULD LIKE TO LEARN MORE
ABOUT THAT I CAN'T COVER TODAY.
IN THE TIME WE HAVE I'M GOING TO
FOCUS ON FY 24 APPROPRIATION AND
PROVIDE SOME CONTEXT TO WHAT I'M
SURE YOU ARE READING IN THE NEW
YORK TIMES AND THE "WALL STREET
JOURNAL" AND WHATEVER OTHER
SOURCES YOU LIKE TO USE. NEXT
SLIDE PLEASE. SO THE TOPICS I
WILL COVER ARE THE DEBT LIMIT
BUDGET DEAL WHICH SORT OF SETS
THE STAGE FOR FY 24. THE FY 24
APPROPRIATIONS HAS SUBMITTED
VERSUS THE SENATE AND THE
CONGRESSIONAL WORK AHEAD AND THE
SHORT TIME THAT IS LEFT BEFORE
FY 24 BEGINS. NEXT SLIDE
PLEASE. SO THE DEBT LIMIT
BUDGET DEAL THAT SET CAPS ON
SPENDING WHICH IS GOING TO MAKE
FY 24 A LEAN BUDGET YEAR NOT AS
LEAN AS SOME WOULD LIKE, THESE
PROCESSES ARE PROCEEDING
DIFFERENTLY IN THE HOUSE AND
SENATE BUT WHEN THE BILL IS
PASSED AND WE AVOID DEFAULTING
ON DEBT IN THE VERY END OF MAY,
BEGINNING OF JUNE, THERE WAS A
CELEBRATORY AIR THAT SPEAKER
MCCARTHY HAD A PRESS CONFERENCE
WITH HIS LEADERSHIP TEAM,
PRESIDENT BIDEN SIGNED THE BILL.
THE HOUSE BUDGET COMMITTEE
CHAIRED BY REPRESENTATIVE JODY
HARRINGTON (PHONETIC) OF TEXAS
PUT OUT A STATEMENT, TOUTING THE
AGREEMENT AS THE LARGEST EVER
DEBT REDUCTION BILL SAYING THIS
IS A CONSTRUCTIVE PATH, AND THIS
WOULD ELIMINATE THE POSSIBILITY
OF A CONTINUING RESOLUTION THAT
WOULD FOR THE ENTIRE YEAR STICK
AT FY 23 FUNDING LEVELS THEY
WERE HAPPY WITH. IT WAS A SHORT
LIVED CELEBRAT CELEBRATION. SPER
MCCARTHY HAD A DAY BEFORE THE
SORT OF VERY FRACTIOUS PART OF
HIS CAUCUS, THE HOUSE
(INAUDIBLE) CAUCUS REVOLUNTEERED
AT THE THOUGHT OF CONTINUING
(INAUDIBLE) FY 24 SO THIS
JOURNAL SUMMARIZE IT IS MAJOR
PARTS OF THE DEBT LIMIT DEAL.
SUSPENSION OF THE DEBT LIMIT IS
ALWAYS AN OPPORTUNITY FOR A
BUDGET DIAL. THERE'S LEVERAGE IN
THE URGENCY OF THE DEBT LIMIT, A
SITS INTENTION THAT IS NEEDED.
BUT TYPICALLY WHEN THERE IS A
BUDGET DEAL REACHED THE PARTIES
STICK WITH THE TERMS AGREED TO
AND MEMORIALIZEIZED IN THE
LEGISLATION. THAT IS NOT WHAT
HAS HAPPENED HERE. THE HOUSE
FREEDOM CAUCUS WERE VERY UPSET
ABOUT THE LEVEL OF CUTS THEY HAD
-- THE HOUSE PASSED A BILL THAT
WOULD TAKE FUNDING BACK TO THE
FY 22 LEVELS THAT IS ESSENTIALLY
WHAT THEY ARE EXISTING ON NOW.
THE PART THAT I HIGHLIGHTED IS
SPENDING WHICH IS THEY ARE
INSISTING A DIFFERENT LEVEL OF
SPENDING AT THIS POINT AND THESE
MAJOR PROVISIONS ARE VERY
DIFFERENT. THE HOUSE GOP IS NOW
SORT OF PIVOTED TO SAYING THE
CAPS DISCUSSED AND AGREED TO IN
THE FISCAL RESPONSIBILITY ACT
FRA ARE A FLOOR, NOT A CEILING.
SO THEY CAN FUND AT LOWER
LEVELS. THAT IS THE MAXIMUM
THEY CAN FUND AT. SO THEY CHANGE
RESCISSIONS AS WELL, THEY
TARGETED SOME OF THE PROGRAMS
THAT DEMOCRATS WOULD HAVE NEVER
AGREED TO IN THIS DEAL AND I
HIGHLIGHTED THIS RESCIND 20
BILLION IRS FUNDING ALLOCATED
THROUGH THE IRA OF THE THAT WAS
AGREED TO ACTUALLY THE SPENDING
BILLS THAT HOUSE REPUBLICANS
ADVANCED ARE TARGETING ABOUT 67
BILLION A BIT MORE THAN THAT
GIVEN IRS FUNDING SPREAD ACROSS
FOUR BILLS SO IT IS REALLY
DIFFERENT THAN WHAT WAS AGREED
TO HERE. I WANT -- I HIGHLIGHTED
THIS SORT OF SKIT THAT YOU CAN
TAKE CONGRESS IS NOT THE MOST
SELF-AWARE ORGANIZATION BUT THEY
DO KNOW HOW DIFFICULT IT IS FOR
THEM TO GET THESE SPENDING BILLS
DONE ON TIME. SO WHAT THEY DID
IS INSERTED A DEADLINE AND A
PENALTY THAT IF ALL 12
APPROPRIATIONS BILLS ARE NOT
DONE BY JANUARY 1 THERE IS A 1%
CUT MANDATORY. THAT WOULD APPLY
NOT ONLY TO DEFENSE BUT ALSO TO
NON-DEFENSE. SO THAT -- THE FACT
IT WOULD APPLY TO DEFENSE IS
SOMETHING THAT WILL GET
ATTENTION OF A LOT OF MEMBERS
WHO MAY NOT SUPPORT
NON-DISCRETIONARY FUNDING WHICH
IS NEAR AND DEAR TO OUR ARTS
BECAUSE THAT IS WHERE NIH GETS
ITS FUNDING. WHERE DOES THIS
LEAVE US? THIS ROLL CALL ARTICLE
THAT TALKED HOUSE AND SENATE ON
A COLLISION COURSE IS NOT AN
OVERSTATEMENT. THE SENATE IS
WRITING TO THE LEVELS THAT WERE
AGREED UPON. THEY HAVE ALSO HAD
A BIPARTISAN AGREEMENT TO ADD
EMERGENCY FUNDING. 2 BILLION
WOULD GO TO THE LABOR HHS BILL
AND EMERGENCY FUNDING ALSO FOR
SUPPLEMENTAL APPROPRIATIONS FOR
SOME OF THE DISASTER AID
REQUIRED NOW. THE HOUSE ENDED UP
WRITING TO 142 BILLION LESS THAN
TOTAL IN THE SENATE AND THAT IS
SIGNIFICANT. THERE IS DEADLINES
NOT ONLY JANUARY 1 DEADLINE I
DESCRIBED BUT OBVIOUSLY OCTOBER
1ST IS WHEN THE FISCAL YEAR
BEGINS IN 24 DAYS FROM NOW.
JANUARY 1ST. NOW THAT ONE
PERCENT REDUCTION IS REQUIRED IF
ALL 12 BILLS AREN'T DONE, IF ALL
12 ARE NOT COMPLETED BY APRIL
30TH THAT CUT BECOMES PERMANENT.
SO WE WILL SEE WHERE THAT GOES
BUT THIS IS REALLY UNUSUAL. IT
ALSO MAKES IT TO ME IT SUGGESTS
THAT WE OFTEN DON'T HAVE FINAL
APPROPRIATIONS UNTIL WELL INTO
THE FISCAL YEAR. THIS APRIL 30TH
DEADLINE COULD POTENTIALLY MEAN
IT WILL BE THAT LONG INTO FISCAL
YEAR BEFORE WE HAVE FINAL
APPROPRIATION. I HOPE THAT IS T
NOT WHAT HAPPENS. BUT THAT IS
VERY DIFFICULT FOR PLANNING
PURPOSES, IT IS VERY DIFFICULT
FOR SETTING TARGETS FOR WHAT WE
ARE ABLE TO INVEST BECAUSE WE
REALLY DON'T KNOW. NEXT SLIDE
PLEASE. I WANTED TO REMINDER
ABOUT PROCESS AND HOW NCI
RECEIVES ITS FUNDING, AS DR.
BERTAGNOLLI REMINDED THE BOARD,
NCI HAS A -- WHAT IS COMMONLY
REFERRED TO AS A BYPASS BUDGET,
A PROFESSIONAL JUDGMENT BUDGET
REQUIRED BY THE NATIONAL CANCER
ACT. AND WE ARE THE ONLY
INSTITUTE THAT IS ABLE TO DO
THIS WITHIN NIH. THERE IS AN
ALZHEIMER'S DISEASE PROFESSIONAL
JUDGMENT BUDGET AS WELL REQUIRED
BY APPROPRIATIONS LANGUAGE THAT
IS ABOUT MAYBE THE PAST 7 OR 8
YEARS, THAT'S BEEN SOMETHING
THAT NIH PRODUCES AND NIA
OFFERS. BUT FOR US THIS IS
REALLY SETTING THE IDEAL LEVELS
TO PURSUE ALL RESEARCH
OPPORTUNITIES AS DR. BERTAGNOLLI
EXPLAINED. WE WANTED TO TALK
ABOUT THAT BRIEFLY JUST TO SAY
THE FY 24 PROFESSIONAL JUDGMENT
BUDGET WAS RELEASED LAST
SEPTEMBER. THE ONE THAT IS
COMING OUT THIS MONTH IS FY 25
THOUGH WE ARE OBVIOUSLY STILL IN
THE THICK OF FY 24 AND NOT
HAVING BEEN COMPLETED. WE ARE
STILL BETWEEN STEPS TWO AND
THREE BECAUSE THE APPROPRIATIONS
COMMITTEES HAVE NOT -- THEY ARE
FAR APART. THEY ARE DIFFERENT --
THEY ARE LOOKING AT DIFFERENT
TOP LINES AND THEY CERTAINLY
HAVE HAVEN'T CONFERENCED
ANYTHING WHICH IS WHERE THEY
COME TOGETHER AND COME UP WITH A
UNIFIED BILL. SO WHAT I WANT TO
POINT OUT HERE IS SORT OF THE
DISCONNECT BETWEEN HOUSE AND
SENATE REPUBLICANS. WHAT WE ARE
SEEING HERE IS SENATOR CORNIN
TWEETED YESTERDAY THAT THE HOUSE
AND SENATE AND HIS WORDS WERE
COMPLETELY DIFFERENT UNIVERSES
WHEN IT COMES TO HOW LAW MAKERS
FUND FEDERAL AGENCIES IN SHORT
APPROXIMATE LONG TERM. SENATE
MINORITY LEADER MITCH MCCONNELL
ALSO SAID YET HE SUPPORTS
SUPPLEMENTAL FUNDING MEASURES
AND TO KEEP THE GOVERNMENT
WORKING AFTER OCTOBER 1ST. THE
LEFT IS A PICTURE OF HOUSE
FREEDOM CAUCUS MEMBERS LED IN
THIS SLIDE BY THIS PHOTO BY CHIP
ROY A FELLOW TEXASN AND SENATOR
CORNIN WHO HAS A DIFFERENT
PERSPECTIVE. THE FREE COME
CAUCUS COMMITTED IN WRITING TO
THEIR REFUSAL TO SUPPORT A
CONTINUING RESOLUTION WITHOUT A
BORDER SECURITY BILL PASSED BY
THE HOUSE, IF IT DOESN'T INCLUDE
POLICY RIDERS THAT WOULD
SOMEWHAT NEGATIVELY EFFECT WITH
DOJ AND FBI. SO WE WILL SEE
WHERE THIS GOES. THEY ARE ALSO
SAYING THAT THEY ARE GOING TO
REFUSE OFTEN TIME THERE'S
CONTINUING RESOLUTIONS THAT SORT
OF RAMP UP THE PROCESS IN TERMS
OF PRESSURE AS IT GETS CLOSE TO
HOLIDAYS USUALLY SOMETIME IN
DECEMBER. SO I DON'T KNOW WHAT
TIME THAT MIGHT EFFECT THE TIME
FRAME OF A CR, WE WILL SEE
INTRODUCED HOPEFULLY SOON. BUT
IT MIGHT BE ONE THAT GOES A
SHORTER TIME FRAME AND NOT
SETTING A DATE FAR OUT, WE WILL
SEE WHAT HAPPENS THERE. IT IS
REALLY REMARKABLE HOW OUT OF
SYNC THE HOUSE AND SENATE
REPUBLICAN PARTIES ARE AND THERE
IS EVEN MORE TURMOIL WITHIN THE
HOUSE GOP BECAUSE THERE'S LOTS
OF VIEW POINTS NOT REFLECTED IN
THIS DEMAND. BY THE HOUSE
FREEDOM CAUCUS. ONE THING TOO,
A CR IS A STOP GAP FUNDING
MEASURE. IT IS SUPPOSED TO
CONTINUE GOVERNMENT FUNDING
WHILE THE TWO PARTIES NEGOTIATE
DIFFERENCES. IT IS NECESSARY
WHEN THERE ISN'T AGREEMENT ON
FUNDING LEVELS OR POTENTIALLY
POLICY ISSUES ASSOCIATED WITH
FUNDING LEVELS FOR AGENCIES. TO
INSIST ON CR THAT INCLUDES
POLICY PROVISIONS IS A LITTLE
DEFEATING THE PURPOSE OF WHAT CR
IS SUPPOSED TO DO. IT WILL BE
VERY DIFFICULT. NEXT SLIDE
PLEASE. WHAT I WANT TO POINT
OUT NOT ONLY BECAUSE I LOVE THIS
PICTURE ON THE FAR LEFT, WHICH
IS THE THEN SITTING FEMALE
SENATORS IN 1997, THEY ARE
CELEBRATING HERE BECAUSE THEY
JUST GOT A SOMEWHAT DECENT SIZE
RESTROOM FOR WOMEN THAT IS NEAR
THE FLOOR OF THE SENATE. SO WHAT
I WANT TO POINT OUT HERE IS THAT
YOU SEE SENATOR SUSAN COLLINS
AND SENATOR PATTY MURRAY ON THE
LEFT AS COLLEAGUES. WHO BOTH
HAVE ALWAYS EARNED THE
REPUTATION OF VALUING THE
BIPARTISAN PROCESS AND
ENGAGEMENT IN NEGOTIATION. YOU
SEE ON THE RIGHT TODAY AS THE
CHAIR AND RANKING MEMBER OF THE
SENATE APPROPRIATIONS COMMITTEE.
I EXCERPTED A STATEMENT THAT
THEY MADE AFTER THE FIRST FULL
COMMITTEE MARK UP AND PRIOR
RECENT YEARS THE SENATE HAS HAD
ENOUGH PARTISAN DISPUTE ABOUT
SPENDING BILLS THEY HAVEN'T
ADVANCED BILLS OUT SUBCOMMITTEES
VERY REGULARLY. OUR BILL
SPECIFICALLY POSTED BY MAJORITY
AND THEN THE CONFERENCE IS THAT
MUCH HARDER TO TRY TO NEGOTIATE
FUNDING LEVELS. BUT YES SEEING A
-- WE ARE SEEING A DIFFERENT
APPROACH THIS YEAR BECAUSE THESE
TWO LEADERS ARE DETERMINED THERE
IS GOING TO BE BIPARTISAN
PROCESS IN THE SENATE
APPROPRIATIONS COMMITTEE AND THE
SENATE HAS REALLY SOME BILLS
HAVE PASSED UNANIMOUSLY, THERE
-- THEY HAVE PASSED ALL THEIR
BILLS OUT OF THE APPROPRIATIONS
COMMITTEE. SO YOU SEE A VERY
DIFFERENT LEVEL OF COOPERATION
AND COLLABORATION IN THE SENATE
AND THE LEADERS OF THESE
APPROPRIATE -- OF THE
APPROPRIATIONS COMMITTEE ON BOTH
SIDES ARE REALLY COMMITTED TO
THAT. AND HAVE BEEN VERY CLOSE
COLLEAGUES FOR DECADES. NEXT
SLIDE PLEASE. SO THIS SLIDE I'M
TRYING TO SHOW THE DISASTER AID,
THIS IS A REALLY BIG DEAL AND IT
MAY HOPEFULLY PROVIDE A LITTLE
MORE MOMENTUM FOR A STOP GAP,
FOR A CLEAN STOP GAP TO GET
THROUGH AND KEEP THE GOVERNMENT
FUNDED AFTER OCTOBER 1ST. THE
WHITE HOUSE HAS REQUESTED AN
ADDITIONAL $4 BILLION BECAUSE OF
THE RECENT HURRICANES AND WILD
FIRES SO YOU KNOW CALIFORNIA,
HAWAII, FLORIDA, VERMONT,
THERE'S BEEN REALLY SIGNIFICANT
FLOODING IN SOME NEW ENGLAND
AREAS, THIS IS ON TOP OF $12
MILLION SUPPLEMENT REQUESTED
EARLIER IN AUGUST, FOR FEMA. THE
OTHER ISSUE THAT IS SOMEWHAT
PARTISAN THAT WILL BE INCLUDED
IN SUPPLEMENTAL EMERGENCY AID
WOULD BE MONEY FOR UKRAINE.
THERE IS CONTINGENT OF MEMBERS
AND CERTAINLY OFFICIAL POSITION
OF THE HOUSE FREEDOM CAUCUS THEY
DON'T WANT WHAT THEY DESCRIBE A
BLANK CHECK TO THE UKRAINE. SO
THERE IS AN URGENCY HERE THAT IS
SIGNIFICANT. ONE SIGNAL I
THOUGHT WAS INTERESTING OVER THE
WEEKEND SPEAKER MCCARTHY MADE A
TRIP TO HAWAII WITH A BIPARTISAN
HOUSE DELEGATION. HE PLEDGED
THERE WAS GOING TO BE SUPPORT
FROM THE GOVERNMENT TO REBUILD,
HE ALSO PLEDGED INVESTIGATION TO
FIGURE OUT WHY THINGS WENT AS --
PROCESS WAS AS IT WAS IN HAWAII
SENATOR MCCONNELL YESTERDAY ALSO
COMMENTED WE ABSOLUTELY HAVE TO
FUNDING THESE DISASTER RELIEF
PRIORITIES. NOT SURE WHAT THAT
MEANS IN TERMS OF THE CR BUT THE
FACT THE SPEAKER TRAVELED TO
HAWAII IS I THINK ENCOURAGING
THAT THIS IS A PRIORITY HE WILL
BE BRINGING BACK TO HOUSE AND
HIS LEADERSHIP TEAM. SO THESE
ARE THE NUMBERS WE ARE LOOKING
AT HERE FOR WHAT THE HOUSE HAS
PASSED, WHAT THE SENATE HAS
PASSED, THESE ARE JUST OUT OF
COMMITTEE, THESE AREN'T PASSAGE.
FOR NIH, NCI AND ARPA H. SO WHAT
WE ARE SEEING IN THE HOUSE THEY
DECLINED TO FILL IN THE
$2,616,000,000 AS PART OF
APPROPRIATION FY 23 FOR THE MOON
SHOT. THAT WAS OF COURSE VIA THE
21ST CENTURY CURE ACT THERE WAS
A MANDATORY FUNDING STREAM IN
YEARS PAST WHERE WE HAD DECREASE
IN MOON SHOT FUNDING LEVELS, THE
APPROPRIATORS HAD TO BACK FILL
THOSE NUMBERS AND THIS REFLECTS
AN ABSENCE OF MOON SHOT BEING ON
A FLAT BUDGET. THE SENATE WOULD
CONTINUE THAT FUNDING BUT WOULD
ALSO PROVIDE INCREASE OF $60
MILLION. OBVIOUSLY THESE ARE
NOT LARGE INCREASES BUT IT IS A
TIGHT BUDGET YEAR, THIS IS WHAT
WE ARE LOOKING AT, AT THIS POINT
IN TIME. WE DON'T KNOW WHERE
THIS IS GOING TO LAND. IT IS
CERTAINLY GOING TO BE A
DIFFICULT NEGOTIATION PROCESS
FOR THE CHAMBERS. I WANTED TO
POINT OUT HERE CONTINUING
RESOLUTIONS ARE VERY, VERY
COMMON SO WHEN YOU SEE THE -- ON
THE LEFT THE COLUMN THAT GOES
OUT TO 365 DAY THOSE ARE WHEN
SOME IF NOT ALL APPROPRIATIONS
BILLS WERE GIVEN A FULL YEAR CR.
THEY SHOW 365 IT WAS TEN OUT OF
TWELVE, FOR EXAMPLE DEFENSE --
THE DEFENSE BILL HAS NOT HAD
THAT SITUATION BUT OTHER BILLS
HAVE. THIS SLIDES GOES UP TO FY
22, IN FQ 23 WE HAD THREE
CONTINUING RESOLUTIONS WHICH
TOOK US THROUGH THE FIRST 90
DAYS OF THE FISCAL YEAR. 90 DAYS
IS BETTER THAN 180 OR 365. SO WE
ARE CAUTIOUSLY OPTIMISTIC THAT
WE WILL END UP WITH SOMETHING
LESS THAN A FULL YEAR CR. LOT OF
WORK AHEAD, THE SENATE RETURNED
FROM THEIR LONG AUGUST RECESS
YESTERDAY, THE HOUSE IS NOT BACK
UNTIL NEXT TUESDAY. THEY ARE
ONLY 11 LEGISLATIVE DAYS IN
SEPTEMBER WHERE BOTH CHAMBERS OF
-- ARE IN SESSION. THE STOP GAP
FUNDING MEASURE IS GOING TO BE
PROBLEMATIC AS WE DISCUSSED.
THERE IS ALSO OTHER MUST HAVE
LEGISLATION, NOT JUST
APPROPRIATIONS THERE IS EXPIRING
FDA USER FEE AUTHORIZATION.
PANDEMIC AUTHORIZATION. FARM
BILL, P IFAA BILL AND NATIONAL
DEFENSE AUTHORIZATION THAT IS A
LOT OF WORK. THESE PRESENT
OPPORTUNITIES. ANY LEGISLATIVE
VEHICLE MOVING PRESENTS AN
OPPORTUNITY. OR SOMETHING TO BE
ATTACHED, MAYBE THERE IS A WAY
THAT LEADERSHIP CAN PEEL
SOMETHING OFF THAT IS A DEMAND
OF THE HOUSE FREEDOM CAUCUS AND
FIND A WAY APPROPRIATE TO
ADDRESS IT SEPARATE FROM
APPROPRIATIONS, BUT THERE IS
OPPORTUNITY IN THE FACT THAT
THINGS ARE MOVING. WHAT WE
EXPECT TO SEE IS SENATE WILL
START MOVING APPROPRIATIONS
BILLS FOR VOTES FOR FLOOR VOTES
AND THEY ARE PROBABLY GOING TO
DO A SERIES OF WHAT IS CALLED
MINI BUS BILLS A COUPLE MAYBE
LESS CONTROVERSIAL BILLS
COMBINED TOGETHER, FREEDOM
CAUCUS HAS INSISTED THEY WILL
NOT VOTE FOR AN OMNIBUS WHICH IS
ALL TOGETHER. A SERIES OF MINI
BUSES IS LESS OBJECTIONABLE,
MORE TIME FOR REVIEW, IT IS LESS
A LIST TO GET THOSE DON DONE. TE
SENATE IS FAR AHEAD DOING THEIR
WORK, THEY MAY FINISH THEIR
BILLS WHAT IS KNOWN AS JAMMING
THE HOUSE -- THE HOUSE SNAPS THE
SENATE BASICALLY DOING ALL YOUR
WORK TOSSING TO THE OTHER SIDE
AND GOING HOME. THIS IS
SOMETHING WE SEE START TO PLAY
OUT AT THE END OF FISCAL YEARS.
I WANTED TO END ON A SOMEWHAT
OPTIMISTIC NOTE DESPITE THE LEAN
BUDGET YEAR WE ARE FACING, I
WANTED TO JUST I THINK SHOWN
THIS SLIDE TO THE BOARD BEFORE.
THESE ARE THE APPROPRIATIONS
COMMITTEES ARE HEADED BY WOMEN
ALL WOMEN FOR THE FIRST TIME
EVER. AND SHOLANDA YOUNG IS THE
SECOND OR THIRD OMB DIRECTOR WHO
IS A WOMAN. THE FIRST AFRICAN
AMERICAN WOMAN TO DIRECT OMB AND
SHE IS A FORMER HOUSE STAFF
PERSON WHO KNOWS MANY OF O THESE
PEOPLE VERY WELL. AND SO I HAVE
SOME CONFIDENCE AND FAITH IN
THESE LEADERS WHO HAVE A LONG
HISTORY OF WORKING IN A
BIPARTISAN WAY TO GET THEIR WORK
DONE. THAT IS MY OPTIMISTIC NOTE
TO CLOSE ON. SLIDE IS MY EMAIL
ADDRESS. GET IN TOUCH PLEASE IF
YOU HAVE ANY QUESTIONS. MY TEAM
AND I ARE HAPPY TO TALK WITH
BOARD MEMBERS AT ANY TIME.
THANK YOU.
>>THANKS, AS USUAL, MK AND
APPRECIATE THE OPTIMISTIC FINAL
POINT IN A -- ON TOP OF WHAT IS
SOMEWHAT SOBERING TO SOME
DEGREE. I THINK AS WE LOOK AT
POTENTIAL OUTCOMES OF THIS
PROCESS. IN THE INTEREST OF TIME
I THINK WE HAVE A PRESENTATION
ON THE BUDGET OVERVIEW FOR NCI
SO PERHAPS WE CAN GO THROUGH
THAT PRESENTATION THAT WILL BE
GIVEN TO US BY WHERE WESTON
RICKS. AND WE WILL ALSO HAVE
PARTICIPATION IN THE DISCUSSION
FROM DR. BERTAGNOLLI, LOWY, AS
WELL AS MK SO WHY NOT GO INTO
THE BUDGET OVERVIEW AND IF IF
THERE ARE QUESTIONS FOR MK WE
CAN DO THEM AFTER THIS.
>>GOOD AFTERNOON. I'M DIRECTOR
OF THE OFFICE OF BUDGET AND
FINANCE HERE AT NCI AND DR.
BERTAGNOLLI AND I WILL TALK
THROUGH THE BUDGET OVERVIEW
HERE. ONE OF THE THINGS I'M
HOPING WILL BE ABLE TO ANSWER
FOR YOU IS WHERE ARE WE AND WHAT
ARE WE LOOKING AT. THIS IS AN
IMAGE CLOSE UP IMAGE OF THE
QUAKING ASPEN TREE, THE LARGEST
ORGANISM ONE OF THE LARGEST
ORGANISMS ON THE PLANET THAT WE
LOOK AT UP CLOSE IT IS DIFFERENT
THAN WHAT WHEN WE LOOK AT IT
MAYBE FACE TO FACE. AND TO LOOK
AT IT AGAIN FROM THE ENVIRONMENT
YOU CAN SEE THE QUAKING ASPEN
TREE LIVES IN A SPECIFIC
ENVIRONMENT, CONTEXT MATTERS.
MY GOAL TODAY IS TO PUT NCI
BUDGET ACTIVITIES INTO SOME
CONTEXT FOR YOU AND WITH DR.
LILY HOPEFULLY -- LOWY WE WILL
HOPEFULLY ANSWER THE QUESTION
WHAT ARE WE AND WHAT ARE WE
LOOKING AT, AT THE SAME TIME
DESCRIBE CHALLENGES AND
OPPORTUNITIES WE HAVE IN FRONTS
OF US. THIS IS A CHART SHOWING
NCI BUDGET OVER THE LAST 20
YEARS. IT SEEMS GENERALLY CLOSE
UP THE LAST SEVERAL YEARS. IF I
PUT INTO THE CONTEXT OF 2003
BUYING POWER IT IS A VERY
DIFFERENT STORY. A NEW DIMENSION
OF THAT COMES INTO FOCUS.
DESPITE BUDGET INCREASES DURING
THE LAST SEVERAL YEARS, NCI
BUYING POWER LAGGED BEHIND OUR
PURCHASE POWERS TODAY. I'M SORRY
PURCHASE POWER OF TWO DECADES
AGO. FURTHERMORE NCI PORTFOLIO
HAS GOTTEN VASTLY MORE
COMPLICATED, FOR EXAMPLE WE HAVE
TEN MORE NCI DESIGNATED CANCER
CENTERS NUMEROUS NEW PROGRAMS
AND GRANT VEHICLES WE USE, AND
MANY MORE INITIATIVES WE ARE
SUPPORTING IN EVEN WITH THIS
ERODED BUYING POWER. ONE MORE
POINT I WANT TO MAKE TO PUT INTO
CONTEXT, THE SUM TOTAL OF THE
MISSED OPPORTUNITY HERE, RIGHT
NOW IF YOU LOOK AT 2013, THAT IS
PROBABLY THE LOW POINT, BUT OVER
THE LAST SEVERAL YEARS WE
RECEIVED BUDGET INCREASES, GONE
ALMOST HALFWAY BACK UP TO WHERE
WE ARE IN 2003. IF YOU WERE TO
SUM UP ACTUALLY ALL OF THESE
LITTLE MISSES EACH FISCAL YEAR
THE TOTAL SUM OF MISSED
OPPORTUNITIES IS REALLY CLOSER
TO 21 BUILD. I WON'T DWELL BUT
WANT TO ZOOM OUT AND PUT A
LITTLE CONTEXT AND SEE A LITTLE
BIT OF THE LANDSCAPE OF WHERE WE
ARE AS AN INSTITUTION BUT ALSO
RECOGNIZE SOME OF THE OUTSIDE
FORCES THAT IMPACT US. NEXT I
WANT TO ZOOM IN CLOSER, AND SHOW
YOU MORE DETAIL. AS WE APPROACH
THE BUDGET EVER FISCAL YEAR, YOU
CAN PUT MOST COSTS INTO THREE
MAJOR BUCKETS. SOME OF THESE
ARE PARALLEL TO THE THINGS YOU
MIGHT HAVE IN YOUR OWN
HOUSEHOLD, IN YOUR OWN BUSINESS
OR YOUR ORGANIZATION. BUT WE
HAVE OUTYEAR COMMITMENTS IN THE
FIRST PART, THOSE ARE CONTINUING
ACTIVITIES, CONTINUING
ACTIVITIES INCLUDE SOME OF THE
THINGS LIKE OUR CONTINUING
GRANTS OR CLINICAL TRIALS,
CANCER CENTERS, BIOREPOSITORIES,
ET CETERA. THEN IN THE MIDDLE
YOU SEE THE PAST ASSESSMENT
SECTION, THIS IS MORE LIKE YOUR
TAXES AND MORTGAGE. WE HAVE A
LOT OF COSTS SOME OF THEM ARE
UNIQUE BECAUSE WE ARE FEDERAL
INSTITUTIONS, WE PAY FOR PROGRAM
EVALUATION, WE PAY FOR A LOT OF
THE TECHNOLOGY WE USE FOR
RECORDING AND TRANSPARENCY, TYPE
OF SECURITY, IS A SIGNIFICANT
ONE THAT IS INCREASED OVER THE
LAST SEVERAL YEARS BECAUSE OF
SOME OF THE OUTSIDE CHALLENGES
WE HAVE IN THE FEDERAL
GOVERNMENT BUT ALSO THE NETWORK
UTILITIES ET CETERA AND WE PAID
CENTRALLY THROUGH NIH. THE LAST
ONE IS THE NEW SCIENTIFIC
OPPORTUNITIES AND THIS IS -- THE
SKY IS THE LIMIT ON THIS ONE,
EXAMPLE I WILL GIVE IS THE
CANCER MOON SHOT DATA
INITIATIVE, DR. BERTAGNOLLI
EARLIER TODAY. THERE ARE ALL
THESE THINGS WE NEED TO PURSUE
IN ORDER TO KEEP CANCER RESEARCH
FLOWING AND FRESH. ONE I WANTED
TO HIGHLIGHT JUST TO BRING A
LITTLE MORE PERSPECTIVE IS THE
OUTYEAR COMMITMENTS. I WILL TALK
YOU THROUGH THIS ONE MORE. IF
YOU WERE TO TAKE JUST THE GRANTS
PORTFOLIO, THAT IS ABOUT
$4.4 BILLION OF OUR BUDGET EVERY
YEAR F. YOU TAKE THAT PORTFOLIO
AND PACK INTO A LITTLE CUBE LIKE
THIS, THEN SHRINK IT DOWN WE ARE
MAKING AN AWARD THIS YEAR FOR
$4.4 BILLION. NEXT YEAR WE
EXPECT TO AWARD NEW GRANTS, EACH
OF THE FOLLOWING YEARS NEW SET
OF GRANTS ALL THOSE BUILD OFF
EACH OTHER IN A WAY THAT ALLOWS
US TO MOVE THINGS FORWARD. NOTE
THAT EACH ONE, A LITTLE BIT
LARGER, MAYBE IT WILL HAVE A
DIFFERENT SET UP INSIDE BUT EACH
WILL PROBABLY COST MORE JUST
BECAUSE THE NEW TECHNOLOGY AND
INFLATION AND OTHER THINGS THAT
ARE HAPPENING, WHILE AT THE SAME
TIME WE ARE SUPPORTING THE
OUTYEAR COSTS OF THOSE
COMMITMENTS WE MAKE USUALLY FOR
MOST GRANTS THEY ARE FIVE YEARS,
SOME ARE SEVEN YEARS SOME TWO
YEARS SO IN GENERAL FIVE YEARS.
THAT CREATES ENORMOUS OUTYEAR
COMMITMENT FOR US AS WE MOVE
FORWARD. ONE OF THE THINGS I
WANT TO BRING UP TO YOU IN IN
THAT SAME CONTEXT THEN QUICKLY
RETURN BACK TO POTENTIAL GAP IN
THE OUTYEARS. RETURN TO THIS
CHART BECAUSE YOU CAN SEE ONCE
AGAIN NCI AS OF TODAY HAS 13%
LESS BUYING POWER IN 2023
COMPARED TO 2003. THIS IS A
SIGNIFICANT GAP WHEN IT COMES TO
EVALUATING WHAT WE HAVE BEEN
ABLE TO DO FOR THE LAST TWO
DECADES. GIVEN THE CONVERSATION
MK PRESENTED TODAY THERE IS A
REAL POSSIBILITY OF CONTINUING
RESOLUTION, THERE'S SEVERAL
YEARS IN HER CHARTS SHE SHOW
THAT THE CONTINUING RESOLUTION
LASTED 365 DAYS. IF THAT WERE
THE CASE AND WE HAVE EXACTLY THE
SAME BUDGET WE DO TODAY YOU CAN
IMAGINE INFLATION DOESN'T WAIT
FOR ANYBODY. THE GAP WILL
INCREASE BASED ON NIH PROJECTED
BIRD PIE PERCENTAGE INCREASE,
THAT WOULD BE ANOTHER $276
MILLION OF PROJECTED INFLATION
WE WILL BE COMBATING HERE TO TRY
TO SUPPORT OUR GRANT AND
ACTIVITIES THAT WE KNOW WE NEED
TO. IN THAT CONTEXT HOPEFULLY
GIVE YOU A LITTLE BIT OF THE
LANDSCAPE NCI IS FACING OR THE
LANDS SCAPING WHICH NCI IS AS WE
FACE THE NEW BUDGET YEARS OVER
THE NEXT WHILE IT IS MY
PRIVILEGE TO TURN THE BATON OVER
TO DR. LOWY FOR HIM TO THEN
FOCUS IN A LITTLE BIT CLOSER ON
SOME OF THE TREES AND OTHER
ACTIVITIES THAT ARE PART OF OUR
BUDGET.
>>WESTON, THANKS VERY MUCH. I
WILL TALK A MINUTE OR SO ABOUT
THIS SLIDE BUT I WANT TO
QUESTION WITH WESTON'S THEME,
DISCUSS FOUR ISSUES. NUMBER ONE,
THE INTERCONNECTEDNESS OF THE
NCI BUDGET. NUMBER TWO, THE RPG
POOL. NUMBER THREE THAT AS
WESTON ALREADY POINTED OUT, WE
DO A LOT OF OTHER IMPORTANT
THINGS BEYOND THE RPG POOL.
NUMBER FOUR, TO TRY TO ADDRESS
THE POSSIBLE IMPACT OF THE
PROPOSED FY 24 BUDGET ON NCI
ACTIVITIES. SO LET'S LOOK AT
THIS SLIDE WHICH EMPHASIZES THE
INTERCONNECTEDNESS OF THE BUDGET
WITH THE GEARS BUT HIGHLIGHTING
THAT THE ULTIMATE GOAL IS TO
IMPROVE HEALTH OUTCOMES. WE NEED
MANY COMPONENTS. THIS SUMMARIZES
SOME OF THOSE CRITICAL
COMPONENTS. OF COURSE, WE NEED
THE RESEARCH FUNDING. BUT THEN
WHAT WE DO WITH IT IS TRAINING
AND WORK FORCE DEVELOPMENT,
RESOURCES FOR RESEARCHERS, THERE
IS OPERATING EXPENSES. THE
CANCER CENTER AND CLINICAL
TRIALS. BUT THESE AND OTHER
COMPONENTS ARE ALL INTERRELATED
FROM THE MOST BASIC RESEARCH TO
THE MOST APPLIED, THAT
ULTIMATELY LEAD TO IMPROVED
HEALTH OUTCOMES. I'M NOW GOING
TO TALK ABOUT THE RPGs AND
JUST TO SHOW YOU WHAT HAS
HAPPENED WITH THEM BUT
IMPORTANTLY MY LAST SLIDE IN
THIS SEGMENT IS GOING TO SHOW
YOU WHAT IS HAPPENED TO MODULAR
AWARDS VERSUS NON-MODULAR AWARDS
AND THEIR IMPACT. FIRST,
RESEARCH PROJECT GRANTS ARE A
LITTLE LESS THAN 50% OF THE
TOTAL NCI BUDGET BUT AS WESTON
POINTED OUT, OUR RESEARCH PART,
THE EXTRAMURAL RESEARCH IS A
MUCH LARGER PROPORTION THAN JUST
THAT. SO THIS IS A SLIDE THAT
TELLS YOU OVER THE LAST TEN
YEARS THE NUMBER OF APPLICATIONS
AND NUMBER OF APPLICANTS TO NCI
WENT UP MUCH FASTER THAN THAT OF
THE APPLICATIONS AND APPLICANTS
TO THE UTTER INSTITUTES AND
CENTERS OF NIH, WHICH BY ITSELF
EVEN IF WE SUPPORT THE SAME
NUMBER OF AWARDS, WOULD CHANGE
YOU THE PAY LINE OR THE SUCCESS
RATE BY MOVING IT DOWN BECAUSE
THE DENOMINATOR HAS GONE UP.
THIS SLIDE SHOWS YOU HOW OVER
THE LAST FEW YEARS I'M NOT LYNN
COLLUDING FY 23 BECAUSE WE ARE
STILL IN THAT BUDGET YEAR AND WE
DON'T HAVE THE ACCESSMENT.
ASSESSMENT BUT BETWEEN 2018 AND
'22, THE TOTAL BUDGET INCREASED
FROM 41% TO 44% FOR THE RPGs
SO THE OTHER INVESTMENTS
INCREASED BY LESS THAN THAT ON A
PERCENTAGE BASIS. YOU HEARD FROM
MONICA EARLIER TODAY THAT WE ARE
CONTINUING TO INCREASE THE SIZE
OF THE RPG POOL DURING FY 23.
THIS SLIDE SHOWS YOU A COUPLE OF
DIFFERENT ITEMS. FIRST IN THE
DARK BLUE WAS THE PAY LINE FOR
EXPERIENCED INVESTIGATORS
BETWEEN 2016 AND '22, WE WENT
FROM TEN DOWN TO EIGHT IN 2019
AND BACK UP TO 11 IN 2022 AND
I'M SURE THE VAST MAJORITY OF
YOU KNOW WE ARE AT THE 12
PERCENTILE THIS YEAR THANKS TO
THE BUDGET INCREASE FOR FY 23,
NOT SHOWN ON THIS SLIDE, EARLY
STAGE INVESTIGATORS RECEIVED AD
5 PERCENTAGE POINT INCREASE IN
TERMS OF PAY LINE. SO THAT WHEN
THE PAY LINE IS 12 PERCENTILE
THIS YEAR, FOR EXPERIENCED
INVESTIGATORS IS THAT IS 17TH
PERCENTILE FOR EARLY STAGE
INVESTIGATORS. SO WE -- THIS
YEAR DESPITE THE INCREASES WE
ARE NOT FUNDING THE OUTYEAR
COSTS, THE NON-COMPETING GRANTS,
AT FULLY 100%. THE REASON IS
THAT THE FUNDS FROM THE TURN
OVER COMPLETED AWARDS AND THE
FUNDS FROM THE APPROPRIATION
WERE NOT QUITE SUFFICIENT SO IN
THOSE SITUATIONS ALWAYS HAVE THE
ISSUE OF SHOULD WHICH MAKE MORE
AWARDS THAT IS HAVE A HIGHER PAY
LINE OR SHOULD WE FUND
NON-COMPETING GRANTS AT 100%
COMMITMENT. WE USUALLY AS WE DID
THIS YEAR PRIORITIZE FUNDING
MORE COMPETING AWARDS OVER
FUNDING THE NON-COMPETING GRANTS
AT FULLY 100%. THIS SLIDE SHOWS
YOU WHAT HAS HAPPENED OVER THE
LAST TEN YEARS BETWEEN THE
MODULAR AWARDS AND THE
NON-MODULAR AWARDS. FIRST THE
MODULAR AWARDS ARE UP TO
$250,000 IN DIRECT COSTS, THEY
ARE THE BOTTOM PART. WHAT I HOPE
YOU CAN APPRECIATE IS THEY HAVE
GONE FROM 63% OF THE AWARDS IN
2012 TO 17% OF THE AWARDS IN
2022. WE HAVE DURING THIS TIME
FOR MOST OF THIS TIME REDUCED
THE AWARD OF THE MODULAR AWARDS
BY 8 1/2% WHICH MEANS A MODULAR
AWARD IN TERMS OF DIRECT COST IS
ABOUT $225,000. IF YOU NOW TURN
YOUR ATTENTION TO THE TOP PART,
THESE ARE THE NON-MODULAR AWARDS
WHICH ARE THOSE THAT ARE MORE
THAN $250,000 IN DIRECT COSTS.
WHAT HAS HATCHED IS -- HAPPENED
IS THEY HAVE GONE FROM BEING
MINORITY OF AWARDS IN 2012, 38%
TO THE VAST MAJORITY, MORE THAN
80%, MORE THAN FOUR OUT OF FIVE
AWARDS IN 2022. MOST OF THESE
NON-MODULAR AWARDS ARE FOR
$499,000 WITH THE 17 PERCENT
DECREASED WHICH MEANS THE ACTUAL
DIRECT COST IS ABOUT $425,000
PER AWARD WHICH IS ABOUT
$200,000 MORE THAN THE MODULAR
AWARDS. THIS IS A TANGIBLE
REFLECTION OF WHAT WESTON HAS
BEEN SHOWING YOU OF THE IMPACT
OF INFLATION AS PEOPLE HAVE
VOTED WITH THEIR FEET BY GOING
FROM MODULAR AWARDS TO MAINLY
NON-MODULAR AWARDS, OVER THE
PAST TEN YEARS. IF WE PROJECT
FORWARD THE NON-MODULAR AWARDS
ARE ALMOST CERTAINLY GOING TO BE
WELL OVER 90% OF THE AWARDS IN
THE NEXT TWO OR THREE YEARS. I
NOW WANT TO TURN OUR ATTENTION
TO THE FACT THAT NCI FUNDS MANY
CRITICAL COMPONENTS OF CANCER
RESEARCH THROUGH MECHANISMS
OUTSIDE THE RPGs. THIS IS
JUST LISTING FOUR OF THEM. THE
SPORE GRANTS, CANCER CENTER
SUPPORT GRANTS, CANCER TRAINING
AND CLINICAL TRIALS NETWORKS.
OBVIOUSLY WE NEED TO SUPPORT
THESE MECHANISMS IN ADDITION TO
THE RPGs. THIS IS TRYING TO
PUT INTO CONTEXT WHAT MK HOLOHAN
WAS TALKING WITH YOU ABOUT WITH
THE BUDGET ACCORDING TO HOUSE
BUDGET OR THE SENATE BUDGET. I
THINK THE MOST IMPORTANT POINT
HERE, FIRST BULLET POINT IS THE
FLAT BUDGET MAY NOT BE FLAT.
THAT IS BECAUSE THE CANCER MOON
SHOT FUNDS WERE NEVER PART OF
THE NCI BASED BUDGET AND THE
HOUSE BUDGET FOR FY 24 DIDN'T
CONSIDER THE FACT THAT THE $216
MILLION FOR MOON SHOT WOULD GO
IN '23 WOULD GO DOWN TO ZERO IN
'24. THE SENATE MARKED BY
CONTRAST DID CONSIDER THIS ISSUE
AND DID ADD THE $216 MILLION TO
THE BASE BUDGET. THEN ADDED $60
MILLION IN ADDITION. $60
MILLION IS A LOT OF MONEY AND IS
VERY GENEROUS ON THE PART OF THE
SENATE. BUT IT IS LESS THAN ONE
PERCENT OF THE NCI FY 24 -- FY
23 BUDGET. IN TERMS OF OTHER
COSTS, THE ESTIMATE IS THAT WE
NEED TO ADD ABOUT $250 MILLION
TO THE RPG POOL IN FY 24 TO
MAINTAIN THE CURRENT 12
PERCENTILE PAY LINE FOR NEW
AWARDS. AND FUND NON-COMPETING
AWARDS AT 100%. ONENA HEADS TO
ADD MORE IF ONE WERE GOING TO
TRY TO GET TO THE 13TH 14TH AND
15TH PERCENTILE WHICH IS WHERE
WE WOULD LIKE NCI TO GO. AS
WESTON MENTIONED NCI INCURS
BETWEEN 75 AND $100 MILLION EACH
YEAR IN INCREASE MANDATORY
EXPENSES. THESE INCLUDE BUT NOT
LIMITED TO, PROGRAM EVALUATION,
CYBER SECURITY AND CENTER FOR
SCIENTIFIC REVIEW EXPENSES. SO
H IS LAST OF MY SLIDES, WHICH IS
TO SAY IF WE HAVE A FLAT BUDGET
IT SEEMS LIKELY THAT ALL PARTS
OF THE NCI BUDGET COULD BE
ADVERSELY AFFECTED AND THIS IS A
PARTIAL LIST. FOR THE RPG POOL I
HOPE IT'S CLEAR FROM WHAT I HAVE
BEEN SAYING THAT IT MAYBE
NECESSARY TO DECREASE THE PAY
LINE FOR NON-AWARDS AND FUND
NON-COMPETING AWARDS AT LOWER
THAN 100% IN FY 24. EVEN CANCER
CENTER SUPPORT GRANTS WE HAVE
NOT TOUCHED PREVIOUSLY, MIGHT BE
NECESSARY TO FORGO SOME
ANTICIPATED INCREASES FOR
COMPETING RENEWALS AND DECREASE
AMOUNT OF NON-COMPETING SUPPORT
GRANTS. CANCER TRAINING AWARDS,
AGAIN, WE HAVE NOT PREVIOUSLY
CONSIDERED DECREASING THEM BUT
MIGHT BE NECESSARY TO MAKE FEWER
NEW AWARDS. SPORE GRANTS, IT
MAY BE NECESSARY TO MAKE FEWER
NEW AWARDS AND REDUCE THE SIZE
OF NON-COMPETING AWARDS. THE
INTRAMURAL RESEARCH PROGRAM
WOULD BE CUT AT LEAST AS MUCH AS
THE EXTRAMURAL AWARDS. I DON'T
MEAN TO BE OVERLY DRAMATIC IN
SHOWING YOU THESE SEVERAL BULLET
POINTS BUT I THINK IT IS
IMPORTANT FOR US TO FACE THAT
THE FISCAL REALITY OF FY 24 IS
NOT LIKELY TO BE AS FAVORABLE AS
IT HAS BEEN IN THE PAS PAST. WED
TO THINK THROUGH SERIOUSLY HOW
TO PRIORITIZE WHAT WE ARE DOING,
AND HOW TO REALLY SUPPORT THE
MOST IMPORTANT CANCER RESEARCH.
BUT I DO WANT TO END PERHAPS
WITH A DIFFERENT MISTIC NOTE
FROM MK'S WHICH IS WE WILL HAVE
A SUBSTANTIAL AMOUNT OF FUNDING
AND CONTINUE TO MAKE THE BEST
PROGRESS THAT WE CAN IN OUR
CANCER RESEARCH. THANKS VERY
MUCH. MONICA, WESTON, MK AND I
WILL BE HAPPY TO ANSWER YOUR
QUESTIONS AND LISTEN TO YOUR
COMMENTS.
>>THANKS, WESTON AND DOUG. IF
WE CAN HAVE MONICA AND MK
AVAILABLE AS WELL, ARE THERE ANY
QUESTIONS OR COMMENTS ABOUT
BUDGET OVERVIEW, BUDGET PROCESS?
CONSEQUENCES. GO AHEAD, ANNA.
>>THANKS, MK. I WOULD LIKE --
THANKS FOR BOTH PRESENTATIONS.
AS AN OVERVIEW I DON'T THINK I
HAVE SEEN IT DONE BETTER. SO MK,
ELECTION YEAR IS COMING UP. SO
WONDERING WHAT YOU ARE GOING TO
MAKE IN TERMS OF IS THAT GOING
TO HAVE IMPACT. PEOPLE DOP ON
BEHALF OF THE CANCER INSTITUTE
AND I'M WONDERING IF THERE
AREN'T OPPORTUNITIES FOR THIS
PARTICULAR ELECTION YEAR TO
MAYBE MOVE THINGS IN A DIFFERENT
DIRECTION LOOKING
OPTIMISTICALLY.
>>WELL, IT IS POSSIBLE WE
CERTAINLY HAVE CANCER CHAMPIONS.
WHEN THERE ARE BUDGET CAPS IN
PLACE, ONE THING THAT IS
IMPORTANT TO UNDERSTAND THEY
WILL NOT WHEN A BUDGET AGREEMENT
SAYS THIS WILL RETURN TO FY 22
LEVELS OR FY 23 LEVELS WE WILL
MAINTAIN THAT WHICH IS WHAT THE
FISCAL RESPONSIBILITY WOULD DO,
IT DOESN'T MEAN EVERY ACCOUNT
AND AGENCY AT THE SAME LEVEL, IT
MEANS THAT'S THE TOP LINE. WE
DID SEE IN THE HOUSE AN SENATE
BILLS THOUGH DIFFERENT WE
CERTAINLY DID SEE PICKING AND
CHOOSING SOME AREAS AND OTHERS
TARGETED FOR REDUCTIONS OR KEPT
FLAT OR MODEST. INCREASES SO IT
IS NOT ACROSS THE BOARD THING. I
DON'T EXPECT GRANULARITY TO BE
DOWN TO ONE INSTITUTE WITHIN
NIH. HOWEVER, WE WILL BE SEEING
THE PRESIDENTIAL ELECTION THAT
IS UPCOMING, AT PLAY CERTAINLY
FOR THE NEXT FISCAL YEAR, HOW
THIS PANS OUT WITH FY 24, THINGS
WILL BE UNDERWAY TO CAMPAIGNING
BUT I DON'T -- I THINK IT IS
MORE WHO IS LEFT HOLDING THE BAG
IF THERE IS A GOVERNMENT SHUT
DOWN IF WE END UP CREATING A
MORE DANGEROUS SITUATION IN
UKRAINE BECAUSE OF CHANGING
SUPPORT FOR THAT EFFORT. THOSE
TYPES OF THINGS ARE GOING TO BE
ISSUES. OVERALL DEBT PROBABLY
DECISIONS OF COVID, DECISIONS OF
UNSPENT MONEY ECONOMICS IS A BIG
PART OF IT, I THINK
INTERNATIONAL ISSUES WOULD BE
AGAIN PART OF IT, I COULD SEE AI
OF BEING AN ISSUE. REALLY
BECAUSE OF THE COMPETITIVENESS
IN CHINA. WE WILL HAVE TO SEE
HOW THAT PLAYS OUT. IT MAKES
EVERYTHING WORSE IN A WAY, THERE
MIGHT BE OPPORTUNITIES BUT THE
STAKES ARE DIFFERENT. AND WE
WILL HAVE TO SEE WHAT HAPPENS.
>>ONE LAST COMMENT, THE DATA
INITIATIVE THAT MONICA ANNOUNCED
TODAY I THINK IS A GAME CHANGER
BECAUSE THIS HAS BEEN A VERY FOR
ALL HEALTHCARE NOT JUST CANCER
WITH THE WHITE HOUSE TAKING
LEADERSHIP HERE I THINK THAT'S A
SEE CHANGE IN TERMS OF WHAT THE
FUTURE HOLDS, FOR ALL CANCER NOT
JUST CANCER BUT CANCER IS
LEADING THIS BUT WE DOPE KNOW
MUCH ABOUT IT YET BUT IT IS LONG
OVERDUE AND IT HAS BEEN A RAY
GOAL FOR THE PRESIDENT TO
ACTUALLY MAKE THIS HAPPEN FOR
MANY YEARS. I WOULDN'T BE
SURPRISED ELECTION YEAR TO SEE
PEOPLE TRY TO ONE UP SOME OF
THESE THINGS WHICH MIGHT BE GOOD
FOR US. KEEP MY FINGERS
CROSSED.
>>I SHOULD REMIND YOU THE DATA
CROSS HHS DATA INITIATIVE IS NOT
RECEIVING ANY EXTRA FUNDING. SO
THIS IS NOT A FUNDED THING. THIS
IS ALL THE AGENCIES SAYING THIS
IS OUR PRIORITY, WE ARE GOING TO
TAKE OUR EXISTING FUNDING AND
EXISTING PROJECTS AND ALL WORK
TOGETHER TO CREATE SOMETHING
SEAMLESS WHICH IS WONDERFUL. I'M
REMINDING YOU THERE IS NO
ADDITIONAL FUNDING WITH THAT
PROJECT.
>>I HAVE TO SAY IF YOU LOOK AT
THE COMMUNITIES OUT THERE,
ALMOST ALL OF THEM ARE VERY
EXCITED ABOUT THIS AND I THINK
THEY WILL BE ADVOCATING NEAR
TERM FOR FUNDING FOR THAT
INITIATIVE.
>>THANKS, ANNA. ANDREA, I SEE
YOUR HAND. PLEASE UNMUTE.
>>YES, CAN YOU HEAR ME.
>>YES.
>>I WANT TO MAKE A COMMENT
FIRST A BRIEF OVERVIEW, I WANT
TO MAKE A COMMENT ABOUT THE
CANCER CENTERS AND FUNDING AND I
WAS WONDERING WHAT SHOULD WE
EXPECT FROM THAT? SHOULD WE
EXPECT THE CANCER CENTERS WILL
(INAUDIBLE) FUNDING BASED ON
SOME METRICS OR WHAT SHOULD WE
EXPECT TO SEE BASED ON BUDGET?
>>THIS IS DOUG. I THINK IT IS
STILL VERY MUCH UNDER
DISCUSSION. BUT I THINK THAT
WHAT THE POINT -- MAIN POINT I
WAS TRYING TO MAKE I THINK, WAS
FIRST OVER THE LAST FEW YEARS WE
HAVE DONE OUR BEST TO FUND THE
CANCER CENTER SUPPORT GRANTS NOT
JUST AT THEIR CURRENT LEVEL BUT
EACH TIME WHEN THE CANCER
CENTERS HAVE COME IN FOR THEIR
RENEWAL TO BE ABLE TO INCREASE
IT AS LONG AS THEY GOT GOOD
SCORESS. FOR FY 24 NEITHER OF
THOSE MAY BE THE CASE. THAT WAS
ALL I WAS TALKING QUALITATIVELY
AND I APOLOGIZE FOR NOT GIVING
YOU A QUANTITATIVE ANSWER.
MONICA MAY WANT TO SAY MORE.
>>I THINK THAT WE REALLY ARE
TRYING TO FOCUS ON WHAT OUR
PRIORITIES AND HOW THE BEST
SUPPORT THE TOTALITY OF THE
COMMUNITY. THIS AS DOUG SAID
THIS IS ONE OF THE OPTIONS ON
THE TABLE.MENT THERE'S THE OLD
PRINCIPLE THAT IF YOU -- IF
EVERYBODY GETS CUT A LITTLE BIT,
THEN IT IS -- YOU CAN DISTRIBUTE
IT, IF YOU FOCUS ON ONE AREA
THERE IS MORE SIGNIFICANT LOSSES
TO THAT INDIVIDUAL ARE AREA. I T
SAY WE ARE CONSIDERING BOTH
APPROACHES AS WE GO ALONG. FOR
EVERYONE TO KNOW WE ARE DOING AN
INCREDIBLY RIGOROUS LOOK AT
EVERY SINGLE PROCESS WITHIN NCI,
LOOKING FOR CONSOLIDATION,
LOOKING FOR ECONOMIES OF SCALE,
LOOKING TO ELIMINATE
REDUNDANCIES AND LOOKING TO
GRADUATE PROJECTS THAT REALLY
SHOULD NO LONGER RECEIVE NCI
SUPPORT SO WE CAN KEEP ANY CUTS
WE NEED TO MAKE TO THE LOWEST
LEVEL POSSIBLE. FINALLY I JUST
HAVE TO SAY WHAT AN INCREDIBLE
DEAL I THINK THE CANCER CENTERS
ARE. I THINK -- PEOPLE HAVE
HEARD ME SAY THIS MANY TIMES FOR
ANY DOLLAR THAT GOES TO THE
CANCER CENTER IT IS LEVERAGED
MULTIPLE, MULTIPLE MULTIPLE
TIMES. SO WHAT AN AMAZING
INVESTMENT. SO MUCH VALUE RETURN
FOR SUCH A SMALL INVESTMENT.
(OVERLAPPING SPEAKERS)
>>I AGREE. THANK YOU.
>>SO WHAT IMPACT WILL HAVE HAVE
ON NCI FREDERICK?
>>NCI FREDERICK IS A SUPPORTIVE
INSTITUTION, FEDERALRY FUNDED
RESEARCH DEVELOPMENT CENTER, A
SUPPORTIVE INSTITUTION THAT HAS
MULTIPLE, MULTIPLE MULTIPLE
AREAS OF INTERSECTION WITHIN THE
NCI PROGRAMS. FOR EXAMPLE, IT
RUNS SOME CORE LAB RESOURCES
THAT ARE USED BY THE EXTRAMURAL
COMMUNITIES SUCH AS CRYOEM
FACILITY, RUNS CONTRACTING
SERVICES USED BY THE NATIONAL
CLINICAL TRIALS NETWORK. IT
PROVIDES CONTACTING AUTHORITY
FOR THAT. IT WILL -- IT IS
PARTICIPATING IN SOME OF OUR
ARPA H ACTIVITIES AS A
CONTRACTING ORGANIZAT ORGANIZATO
FREDERICK IS THERE TO SUPPORT
LIKE EVERYTHING WE DO AND WE GET
INCREDIBLE VALUE OUT OF BEING
ABLE TO HAVE THAT FFRDC
MECHANISM SO THE BOTTOM LINE IS
ANYTHING THAT IS EFFECTIVE AT
NCI IS GOING TO HAVE A COUNTER
PART AFFECTED AT FREDERICK. PART
OF WHAT WE ARE DOING TODAY IS
WORKING THROUGH ALL THOSE
COMPLEX INTERRELATIONSHIPS AS WE
DECIDE EXACTLY WHAT IS THE MOST
EFFICIENT WAY TO USE OUR MONEY.
>>THANKS, MONICA. YSABEL, I SEE
YOUR HAND UP.
>>HOPEFULLY (INAUDIBLE) YOU WOK
THIS COMPLEX -- ALL THINGS BEING
FAIR IN LOVE AND WAR, ARE YOU
LOOKING AT METRICS TO SEE WHO
HAVE BEEN THOSE MOST RESPONSIVE
TO ACHIEVING ADDRESSING
DISPARITIES THROUGH THEIR CANCER
CENTERS AND WHETHER THAT MIGHT
MAKE SOME DECISIONS IS ABOUT
WHERE IT'S FAIR TO CUT AND WHAT
IS FAIR TO CUT AND WHETHER OR
NOT THOSE PARTICULAR CENTERS
DOING THE WORK MIGHT GET A
LITTLE INCENTIVE OPPOSED TO
OTHERS. I JUST -- IN A TIME
WHERE FINALLY WE THINK
DISPARITIES ARING WITH ADDRES
ADDRESSED, -- ARE BEING
ADDRESSED AND STILL BEING
UNDERFUNDED RESEARCH IT WOULD BE
UNCONSCIONABLE TO STEP BACKWARDS
AT THE CANCER CENTERS WHERE YOU
SEE THEY HAVEN'T DONE ENOUGH BUT
NAY ARE TRYING AND THEN WE GET
THIS CUT THAT MIGHT FORCE
CHANGES AND ONCE AGAIN STEP
BACKS.
>>IS MONICA ON?
>>I DON'T KNOW IF SHE -- SEEMED
LIKE SHE WAS HAVING CONNECTION
ISSUES EARLIER, I WONNER IF WE
LOST --
>>LET ME TRY TO ADDRESS YOUR
IMPORTANT QUESTION. THERE ARE
MANY FACTORS THAT CANCER CENTERS
ARE JUDGED BY. AND THE PEER
REVIEW PROCESS CERTAINLY HAS
BEEN LOOKING AT THE ISSUE THAT
YOU ARE -- THAT YOU ARE
DESCRIBING. THIS HAS BECOME AS
YOU ARE WELL AWARE, A VERY
IMPORTANT ISSUE IN TERMS OF
COMMUNITY OUTREACH, ET CETERA.
WHETHER THE -- WHETHER THE
CHANGES IN FUNDING MIGHT OCCUR
WITH ONLY THAT CRITERION, I
DOUBT, I WOULD IMAGINE IT WOULD
BE ONE OF NUMEROUS CRITERIA THAT
WOULD BE CONSIDERED. MONICA DID
YOU HEAR YSABEL'S QUESTION?
>>I DROPPED I HAD TO GET BACK
IN.
>>IF I MAY PARAPHRASE, YSABEL
CORRECT ME IF I'M WRONG, YSABEL
WAS WONDERING IN TERMS OF THE
CANCER CENTERS WHETHER IT MIGHT
BE POSSIBLE TO INTERNALLY AS
RESEARCH LEVEL OR EXTERNALLY AT
DEVELOPING THAT, INCLUDING MORE
COMMUNITIES OF COLOR AT THE
COMPREHENSIVE CANCER CENTERS FOR
CARE,, JUST WONDERING IF THERE
IS ANY METRICS OR MEASUREMENTS
YOU ARE LOOKING AT.
>>MONICA, I BASICALLY SAID IT
IS COMPLICATED. DIFFERENT
FACTORS.
>>I KNOW. AND OUR CENTER FOR
REDUCING HEALTHCARE DISPARITIES
LOOKS AT WORK FORCE IN GREAT
DETAIL AS RESPONSIBLE FOR THAT
AND IS INVOLVED IN MANY -- IN
SUPPORT MECHANISMS TO HELP.
THERE IS MULTIPLE MECHANISMS
THAT ARE BROUGHT TO BARE TO
SUPPORT THESE ISSUES. WE HAVE --
SOME DIRECTED DIRECTLY THROUGH
CANCER CENTERS THEMSELVES AND
OTHERS ARE INDEPENDENT
RESEARCHER INITIATED AWARDS.
>>AMY.
>>ONE OF THE THINGS WE ARE
GOING THROUGH, I SUSPECT
EVERYBODY HAS THE SAME ISSUES
THAT THE CENTERS WERE IS WHERE
YOU GET CANCER CENTER DIRECTOR
WHO SPENDS TWO YEARS RAMPING UP
TO THE RENEWAL. THIS IS AN
EXTREMELY TIME CONSUMING
ENDEAVOR THAT INVOLVES HUNDREDS
OF FACULTY MEMBERS WRITING
REPORTS, ET CETERA. IN REALITY
WE ARE LOOK FOR KEY METRICS. SO
WHAT ABOUT STREAMLINING AND
GETTING AWAY FROM THE
DISTRACTIONS OF THESE
INTRA-ADVISORY BOARDS, EXTERNAL
ADVISORY BOARDS. WE TELL THE
DIRECTORS THESE ARE THE KEY
CRITERIA. DO YOU HAVE THIS MANY
COMMUNITY BASED CLINICAL TRIALS,
IF THAT IS A KEY CLINICAL,
REMEMBER WE WANT THESE CENTERS
BY, IT IS IN THE PRINTERER. WE
SEND THE STANDARDIZED FORM.
TRAINING GRANTS, HOW MANY, WHERE
ARE THEY PUBLISHED AT, HOW MANY
FOLKS WENT INTO ACADEMICS. T
WHAT IS THE NUMBER, SCORE. HOW
MANY PEOPLE HOW MANY CLINICAL
TRIALS. INTERVENTIONAL VERSUS
JUST SIMPLY ANALYSIS SORT OF
STUDIES OR RADIOGRAPHIC STUDIES
THEY JUST SIMPLY GIVE US THE
NUMBERS THERE, IS A SCORE. THAT
GIVES THEM THEIR BASELINE
FUNDING. AND IT REDUCES ALL OF
THE NEEDLESS WORK. BECAUSE WE
ARE LOOKING FOR CERTAIN THINGS
WHY CAN WE NOT SIMPLIFY THE
PROCESS ON BOTH SIDES OF THE
STREET.
>>MUTED.
>>I CAN START. AND SAY THAT I'M
ABSOLUTELY IN FAVOR OF REDUCING
WORK THAT BRINGS NO VALUE.
ABSOLUTELY. HOWEVER, IN MY
PREVIOUS LIFE I SERVED ON MANY
CANCER CENTER ADVISORY BOARDS. I
ALSO WAS THE RECIPIENT AT MY OWN
CANCER CENTER OF INTERACTION AND
ADVICE FROM THE VARIOUS ADVISORY
BOARDS AND INTERACTIONS. AND I
THINK THEY WERE INCREDIBLY
VALUABLE THEY HELPED ESTABLISH
RELATIONSHIPS, NETWORKING,
ELIMINATED SILOS, LED TO JOINT
PROGRAMS AND WAS IN ADDITION TO
HELPING A CANCER CENTER COME
FORWARD AND PRODUCE AN EFFECTIVE
LIST OF PROGRAMS BECAME SOME OF
THE MORE VALUABLE INTERACTIONS
AND RELATIONSHIPS WITH
COLLEAGUES I HAD IN MY -- AT
THAT PHASE OF MY PROFESSIONAL
LIFE. SO I HEAR YOU WHEN IT
COMES TO ACTIVITIES THAT DON'T
PRODUCE VALUE, I GUESS I DON'T
THINK THAT INTERACTIONS WITHIN A
CANCER CENTER OR ACROSS
DIFFERENT CANCER CENTERS AND
DIFFERENT COMMUNITIES IN FORM OF
ADVISORY BOARDS. I PERSONALLY
THINK THOSE BRING VALUE.
>>THAT MAY BE -- THAT IS
ABSOLUTELY TRUE BUT SO MUCH IS A
DOG AND PONY SHOW, LET'S BE
HONEST. EVERYBODY IS BRINGING
OUT THEIR HIGHLIGHTS THEY ARE
TRYING TO IMPRESS THE EXTERNAL
ADVISORY BOARD, ET CETERA AS
OPPOSED TO GETTING DOWN TO THE
BUSINESS OF WHAT IS THE AMOUNT
WE ARE GOING TO FUND FOR CANCER
CENTER BASED ON PERFORMANCE
ESSENTIALLY THAT IS WHAT THIS IS
ABOUT. SO LET'S GIVE THEM A
MATRIX AND SAY OKAY, IF YOU GO
ABOVE THIS LEVEL OF PERFORMANCE
THEN THIS ADDITIONAL AMOUNT. IF
YOU ARE ADDRESSING CATCHMENT YOU
GET ADDITIONAL AMOUNT HERE,
ENHANCING DIVERSITY IN YOUR
COMMUNITY, YOU GET THIS MUCH
ADDITIONAL AMOUNT. AS OPPOSED
TO, IF THEY WANT TO CONVENE
EXTERNAL ADVISORY BOARD TO
CONFORM PROGRAMS THEY CAN DO
THIS. I'M SAYING THAT IS TAKING
AN ENORMOUS AMOUNT OF EFFORT
AWAY FROM SCIENCE SO THAT
SOMEBODY CAN CREATE PRETTY
GRAPHS AND ALL THIS OTHER STUFF
FOR A LIMITED NUMBER OF PEOPLE
TO REVIEW AS OPPOSED TO WHEN WE
ARE INTERESTED IN THE KEY
METRICS WHICH IS ARE THEY
TRAINING PEOPLE THAT ARE GOING
INTO ACADEMIC MEDICINE OR SIZE
AND IF SO, WHAT IS THE NUMBER
FOR THIS PARTICULAR INSTITUTION.
HOW MANY INTERVENTIONAL CLINICAL
TRIALS ARE THEY RUNNING. HOW
MANY DIVERSIFIED PATIENTS ARE
THEY PUTTING ON THEIR CLINICAL
TRIALS? I SUSPECT WE CAN ALL
SORT OF AGREE ON SOME KEY
METRICS AS OPPOSED TO TRYING TO
COVER THIS ALL IN ADDITIONAL
DETAIL THAT MAY NOT NECESSARILY
BE NECESSARY FOR US MAKING THESE
KEY FUNDING DECISIONS FOR THESE
CANCER CENTERS AND IT IS
REDUCING THE EFFORT FOR THEM TO
RENEG.
>>INTERESTING I THINK JUST SORT
OF METRICS BASED APPROACH,
DEFINITELY SOMETHING THAT WE CAN
HAVE FOLLOW-UP DISCUSSION AROUND
FOR SURE. I GUESS WE HAVE A
COUPLE MORE MINUTES. LOVE TO
HEAR MORE ABOUT THE PRODUCTS
ABOUT THE ORIGINAL MOON SHOT.
WHEN WE DO NOW, ALL THE
INVESTMENT THAT WAS PUT INTO THE
-- AND SOME IS STILL ONGOING. IT
HAS BEEN AMAZING. RIGHT WHERE DO
WE GO WITH IT NOW? GIVEN THE
BUDGET SITUATION OR NOT, WHERE
DO WE TAKE THE PRODUCTS OF THE
ORIGINAL -- WHAT ARE THE
PRODUCTS AND HOW TO ADVANCE
THOSE THINGS FORWARD? I SEE A
SMILE ON YOUR FACE MONICA.
>>I WOULD LOVE TO TAKE ON THIS
QUESTION BUT I'M GOING TO HAND
OVER TO THE PERSON WHO IS REALLY
BEEN THE GUIDING LIGHT. WHY
DON'T YOU TAKE THIS ONE BECAUSE
I'M SURE -- YOU DESERVE THE
CREDIT.
>>I WANTED TO HEAR YOUR VOICE,
DANDANA.
>>IT IS PROBABLY WORTH HAVING A
MORE FORMAL PRESENTATION TO GIVE
AN OVERVIEW OF EVERYTHING THAT'S
BEEN ACCOMPLISHED, AS YOU
POINTED OUT IT IS GETTING
ENORMOUS ACROSS THE ENTIRE
SPECTRUM OF CANCER RESEARCH. WE
HAVE BEEN PLANNING OVER THE PAST
YEAR AND A HALF, TWO YEARS. HOW
DO WE MAINTAIN AND CONTINUE THE
SUPPORT THE REALLY IMPORTANT
RESEARCH STARTED UNDER THE MOON
SHOT? AND WE HAVE BEEN PLANNING
WHAT WE HAVE BEEN CALLING A SOFT
LANDING IF YOU WILL. NUMBER OF
PROGRAMS HAVE ALREADY COMPLETED
THE WORK THEY SET OUT TO DO.
OTHERS HAVE ALREADY TRANSITIONED
TO RPG FUNDING. SO THE NEW
FUNDING IS BUILDING ON WHAT WAS
ACCOMPLISHED BY THE MOON SHOT
AND THAT IS NEW PROGRAMS. THERE
ARE OTHER PROGRAMS THAT NEED TO
BE SLOWLY TRANSITIONED OVER SO
WE HAVE BEEN BUDGETING TO ALLOW
SOME OF THOSE TO CONTINUE OR A
YEAR OR TWO UNDER MOON SHOT
FUNDING, AS THE RPG FUNDING
PICKS UP, WE ARE TAKING INTO
ACCOUNT AS WE THINK ABOUT IT
NOW, WHAT THE POTENTIAL FLAT
BUDGET, THE NEW BUDGETING MIGHT
MEAN SO WE DO HAVE MOON SHOT
FUNDS STILL THAT WE SET ASIDE TO
BE ABLE TO CONTINUE SUPPORT SOME
OF THOSE CRITICAL MOON SHOT
PROGRAMS. WE ARE HOPING THAT WE
CAN GET THROUGH THE NEXT YEAR OR
TWO WITH CONTINUED SUPPORT FOR
THOSE MOON SHOT PROGRAMS TO THEN
BE ABLE TO GO TO THE NEXT PHASE
WITH APPROPRIATED FUNDS. HAPPY
TO GIVE YOU A PRESENTATION ON
THE SCIENCE.
>>THAT WOULD BE GREAT FOR
UPCOMING MEETING. NOT DETAILS ON
ANY SPECIFIC PROGRAM BUT MOON
SHOT AS A WHOLE AND OTHER PLANS,
ADVANCE IT FORWARD. THANKS.
OKAY. I THINK WE ARE ABOUT OUT
OF TIME FOR THIS PARTICULAR
COMPONENT OF THE MEETING. I
THINK NOW WE HAVE A BREAK,
15-MINUTE BREAK, WE WILL
RECONVENE AT 3 P.M. EASTERN
TIME. WE WILL HAVE A
PRESENTATION ON COLLABORATIVE
APPROACHES TO ACCELERATE BETTER
THERAPIES FOR PATIENTS WITH RARE
TUMORS. DON'T LOG OFF JUST TURN
OFF YOUR CAMERAS AND MICROPHONES
AND PLEASE LOG BACK IN PROMPTLY
COUPLE OF MINUTES BEFORE THE TOP
OF THE HOUR.
>>OUR NEXT PRESENTATION IS
COLLABORATIVE APPROACHES TO
ACCELERATE THERAPIES FOR
PATIENTS WITH RARE TUMORS GIVEN
BY DRS. BRING JET WIDEMANN,
CHIEF PEDIATRIC DOG BRANCH,
CENTER FOR CANCER RESEARCH AS
WELL AS SPECIAL ADVISOR TO THE
NCI DIRECTOR FOR CHILDHOOD
CANCERS, AND CAR LOSS REILLY,
PEDIATRIC ONCOLOGY BRANCH,
DIRECTOR NCI RARE TUMOR
INITIATIVE CENTER FOR CANCER
RESEARCH. BRIBGETTE AND CARLIN.
>>THANK YOU FOR --
>>WE ARE SEEING THE PRESENTER
VIEW RIGHT NOW,. THERE YOU GO.
>>THANK YOU FOR THE OPPORTUNITY
TO PRESENT ON COLLABORATIVE
APPROACHES TO ACCELERATE BETTER
THERAPIES FOR PATIENTS WITH RARE
TUMORS. DR. REILLY AND I AND I
WILL PRESENT THIS ON BEHALF OF A
NUMBER OF COLLABORATIONS,
INTRAMURAL AND AS WELL AS
EXTRAMURAL I'M PROVIDING AN
OVERVIEW OF THE TALK HERE. I
WILL START WITH A DEFINITION OF
RARE TUMORS AND CHALLENGES
ASSOCIATED WITH RARE TUMORS.
THEN GIVE AN OVERVIEW OF
LANDSCAPE ANALYSIS CONDUCTED OF
ONGOING RARE TUMOR EFFORTS,
PROVIDE RESULTS ON THE CANCER
MOON SHOT SUPPORT MY PEDIATRIC
AND RARE TUMOR NETWORK WHICH
LINKS TO THE NCI CHILDHOOD
CANCER DATA INITIATIVE NATIONAL
RARE TUMOR WHERE WE HOPE TO
ESTABLISH INTERNATIONAL
COLLABORATION AS WELL. THEN DR.
REILLY WILL TAKE OVER TO PRESENT
ON EXCITING NEW DEVELOP PUBLIC
PRIVATE PARTNERSHIP TO ENABLE
DRUG DEVELOPMENT FOR ULTRA RARE
TUMORS. RARE TUMORS ARE DEFINED
BY INCIDENCE OF WHETHER HE SAYS
THAN 150 MILLION PER YEAR. 25%
OF ALL CANCER DIAGNOSIS ACCOUNT
FOR RARE TUMORS AND THE SAME
PERCENTAGE ACCOUNTS FOR CANCER
DEATH SO IT IS SUBSTANTIAL
BURDEN. IMPORTANTLY, ALL
PEDIATRIC CANCER CNS CANCER
SARCOMAS ARE RARE. I KNOW YOU
ARE AWARE OF CHALLENGES FOR
PATIENTS WHICH INCLUDE A LONG
TIME TO DIAGNOSIS, LIMITED
EXPERT TEE AT MANY MEDICAL
CENTERS FREQUENTLY LACK OF
STANDARD OF CARE AND LIMITED
SOCIAL AND ADVOCACY SUPPORT. THE
CHALLENGES FOR RESEARCH ARE JUST
AS IMPORTANT WHERE IT IS
DIFFICULT TO DEVELOP CLINICAL
TRIALS FOR RARE CANCERS, IT IS
HARD TO ENROLL ON THESE TRIALS.
WE HAVE LIMITED TOOLS AND
DIVERSITY OF PRE-CLINICAL
MODELS, THERE'S LIMITED SUPPORT
FROM GRANTING AGENCIES AND
LIMITED INTEREST AND INCENTIVE
FOR INDUSTRY TO COLLABORATE DR.
REILLY WILL ADDRESS WITH PRIVATE
PUBLIC PARTNERSHIP. IN 2019 WHEN
THE NCI CHILDHOOD KAREN DATA
INITIATIVE STARTED WE NOTICED
RARE TUMOR EFFORTS ONGOING
HOWEVER WE GOT THE SENSE THESE
EFFORTS WERE NOT ALL CONNECTED.
SO WE CONDUCTED INTERNET SEARCH
AND LITERATURE RESEARCH FOR RARE
TUMOR PROGRAMS AND ANYTHING THAT
WE COULD FIND. WE IDENTIFIED 76
PROGRAMS THROUGH THIS SEARCH.
WHICH WE WERE ABLE TO CONTACT 42
PROGRAMS. WE DEVELOPED A SURVEY
TO GET INFORMATION ABOUT THE
NATURE OF THESE PROGRAMS AND OF
THE 42 WE CONTACTED WE RECEIVED
23 RESPONSES. AS YOU CAN SEE,
THE SOURCES OF FUNDING WERE
PHILANTHROPY ADVOCACY AND
GOVERNMENT. MIDDLE COLUMN YOU
SEE THE DATA COLLECTED INCLUDING
CLINICAL DATA BIOSPECIMEN DATA
AND FAMILY HISTORY OF NOTE
THOUGH ONLY FEW PROGRAMS
CONDUCTED AND COMPLETED DATA
LONGITUDINALLY AND RATHER SMALL
NUMBER CONDUCTED PATIENT
REPORTED OUTCOMES. IN THE
EFFORTS. WHEN YOU LOOK AT THE
EFFORTS TO SHARE DATA IT IS
OBVIOUS NUMBER OF THE PROGRAMS
ARE SHARING THEIR DATA IN NIH
DATABASES BUT THERE WERE NUMBER
OF PROGRAMS SHARING DATA IN
OTHER DATABASES AND THEY
COMMENTED THAT IT IS DIFFICULT
TO FIND AND SHARE THE DATA AND
MAKE IT ACCESSIBLE WHICH IS
SOMETHING THE CCDI PLANS TO
ADDRESS. I WILL NOW OFFER YOU A
FAIR PEDIATRIC AND DIRECTIONAL
NETWORK IN SHORT MY PART WHICH
RECEIVES FUNDING FROM THE CANCER
MOON SHOT THROUGH THE PATIENT
ENGAGEMENT NETWORK, WHILE
EFFORTS WERE TO INCREASE PATIENT
AND FAMILY INVOLVEMENT IN RARE
TUMOR RESEARCH WITH THE ULTIMATE
GOAL TO DEVELOP NEW THERAPY FOR
RARE PEDIATRIC AND SOLID TUMORS
THROUGH INCREASE UNDERSTANDING
OF TUMOR BIOLOGY AND THE NATURAL
HISTORY. OUR GOAL WAS TO FOCUS
ON CHILDREN TEENS AND YOUNG
ADULTS WITH SOLID TUMORS,
HOWEVER FOR SOLID TUMORS THAT
OCCUR IN THESE GROUPS ALSO
OBSERVED IN ADULTS WE WANT TO
INCLUDE ADULT PATIENTS TO STUDY
BIOLOGY OF TUMORS ACROSS AGES.
OUR GOAL IS TO ENGAGE MULTIPLE
STAKEHOLDERS IN RESEARCH AS
PARTNERS, AND TO DEVELOP A
NATURAL HISTORY STUDY THAT WOULD
LONGITUDINALLY COLLECT MULTIPLE
DATA AS I WILL SHOW YOU LATER.
IN COLLABORATION WITH EXTRAMURAL
PARTNERS WE WILL ALSO PLANNING
TO HOST WORKSHOPS AND SYMPOSIA
ON RARE TUMORS TO DEVELOP EXPERT
CONSENSUS, AND TO HOST MULTI-DAY
CLINICS AT NIH ON RARE TUMORSS.
FOR THESE CONNECTS WE BRING
PATIENTS AND NATIONWIDE EXPERTS
TO THE NIH CLINICAL CENTER TO
STUDY RARE TUMORS JOINTLY. OUR
GOAL WAS TO ESTABLISH A
MULTI-NETWORK OF SITES TO
COLLABORATE AND I WILL SHOW YOU
IN A FEW MINUTES HOW WE
ACCOMPLISHED THIS FOR PEDIATRIC
SARCOMA AS AN EXAMPLE. THIS
SLIDE SHOWS SOME OF THE KEY
ACCOMPLISHMENTS OF MY PART.
FIRST WE WERE SUCCESSFUL IN
DEVELOPING A NATURAL HISTORY
STUDY WITH TUMOR SPECIFIC SUB
PROTOCOLS. WE WERE PREPARED
FROM THE GET GO FOR THE COVID
PANDEMIC BY ALLOWING PATIENTS TO
ENROLL REMOTELY OR IN PERSON AT
THE NIH CLINICAL CENTER. WE
ANALYZE TUMOR BLOOD SALIVA
BIOSPECIMENS, EXPANDED NIH RARE
TUMOR CLINICS AT THE NIH AND
PARTICIPATED AND CONTRIBUTED TO
THE INTERVENTIONAL TRIALS FOR
BOTH CHILDREN AND ADULTS WITH
RARE TUMORS FULL COLLABORATION
WITH THE NCI DEVELOPMENT OF
THERAPEUTICS CLINIC. ALSO HIGHLY
COMMITTED TO NOT ONLY COLLECTING
DATA BUT GETTING THE DATA INTO
SHAPE THEY CAN BE SUBMITTED TO
DB GAP AND SEE HERE THE DATA
FEELS WE HAVE FOR THE FIRST 200
PATIENTS AND WE HOPE TO RELEASE
THIS DATA PUBLICLY BY THE FOURTH
QUARTER OF THIS YEAR. THE NEXT
SLIDE GIVES AN OVERVIEW OF THE
NATURAL HISTORY STUDY FOR RARE
SOLID TUMORS. DR. MARY FRANCIS
(INAUDIBLE) AND DR. HEIDI
(INAUDIBLE) ADULT ONCOLOGISTS
BOTH ENSURE WE PUT IN MORE
PEDIATRIC PATIENTSND ADULT
PATIENTS. WE ARE CONDUCTING
STANDARDIZED LONGITUDINAL
EVALUATIONS WHERE PATIENTS AND
FAMILY COMPLETE FAMILY HISTORY,
MEDICAL HISTORY, PATIENT
REPORTED OUTCOMES, WE CONDUCT
EXTENSIVE OBSTRUCTION OF DATA WE
RECEIVE FROM THE OUTSIDE,
COLLECT IMAGING AND PATHOLOGY,
ONCE A PATIENT IS ENROLLED EVEN
REMOTELY OR AT THE NIH CLINICAL
CENTER WE REVIEW ALL DATA HAVE A
COMPREHENSIVE MOLECULAR TUMOR
BOARD, GENETIC COUNSELING,
PROVIDE RECOMMENDATIONS TO THE
PATIENTS AND CONTINUE TO FOLLOW
THEM LONGITUDINALLY. THIS GIVES
YOU A SNAP SHOT OF THE
ENROLLMENT ON THE NATURAL
HISTORY STUDIES SINCE 2019.
GIVEN THE TUMORS THAT WE
DEVELOPED THE MOST EXPERTISE AND
ACTUALLY THE RANGE WAS MORE
ADULTS AND PEDIATRIC PATIENTS,
WE ENROLLED PATIENTS ACROSS 46
STATES IN THE UNITED STATES, AND
WITHIN 27 COUNTRIES OUTSIDE OF
THE U.S. NEXT SHOWS WHAT TYPES
OF TUMORS WE ENROLLED MOST ON
AND TUMORS WERE THEY DEVELOP AND
CONSIDER MEANINGFUL COHORT FOR
CORDOMA WILD TYPE NEURAL
ENDOCRINE TUMORS CORTICAL
CARCINOMA AND MEDICAL THYROID
CARCINOMA. I WANT TO HIGHLIGHT
ADULTS USE THE SAME PROTOCOL TO
STUDY RARE CANCER SUCH AS
ADENOUS SQUAMOUS CARCINOMA OF
THE PANCREAS. WE HAVE A NUMBER
OF TUMORS WE HAVE FEWER PATIENTS
AND ON THE RIGHT TWO COLUMNS YOU
SEE TUMORS WE HAVE ONE
PARTICIPANT OR TWO PARTICIPANTS,
I THINK THIS WAS AN IMPORTANT
LEARNING EXPERIENCE FOR US ON MY
PART THEY NEED TO MAKE PROGRESS
IN MANY RARE TUMORS WE NEED A
NATIONAL POTENTIALLY
INTERNATIONAL COLLABORATION SO
ALL OF OUR N OF ONE TUMORS CAN
BECOME A LARGER GROUP THAT
BECAME MEANINGFUL STUDY. THE
NEXT SLIDE IS OVERVIEW OF
ENROLLMENT FROM 2019 TO DATE,
YOU CAN SEE WE STARTED WITH
ENROLLING MOST OF THE PATIENTS
AT THE NIH CLINICAL CENTER
DURING THE COVID PANDEMIC WE
SHIFTED TO REMOTE ENROLLMENT AS
WE WERE NOT ALLOWED TO BRING
PATIENTS TO THE CLINICAL CENTER
UNLESS WE HAD CLEAR BENEFIT BUT
WE COULD PROVIDE TO PATIENTS.
NOW THE COVID MAKE HAS COME TO
END OR ENDING WE STILL ENROLL
FAIR NUMBER OF PATIENTS REMOTELY
AS THIS CAN BE VERY MEANINGFUL
FOR PATIENTS THAT LIVE IN ORAL
OR REMOTE LOCATIONS. THE NEXT
SLIDE IS IMPORTANT AND IT SHOWS
OUR AGENDA, RACE AND ETHNICITY,
REHAD PREDOMINANTLY FEMALES
WHICH IN PART IS DUE TO
PREDOMINANCE OF TUMORS IN
FEMALES SUCH AS WILD TYPE
(INAUDIBLE) AS YOU CAN SEE WE
ENROLLED WHITE PATIENTS, AND WE
HAD FAIRLY SMALL NUMBER OF ASIAN
AND BLACK PATIENTS. WHAT IS ALSO
IMPORTANT IS THAT WE COMPARED
REPORTING OF RACE BASED ON
MEDICAL RECORD AND MEDICAL
RECORD AND SELF-REPORT, AS YOU
CAN SEE THERE WAS A DISCREPANCY
BETWEEN MEDICAL RECORD AND
SELF-REPORT AND WE FEEL STRONGLY
THAT SELF-REPORTING WILL BE THE
WAY TO MOVE FORWARD. WE ARE
WORKING WITH A PEER DIVERSITY
WORKING GROUP AND CCCR TO SEE
HOW WE CAN INCREASE RECRUITMENT
OF UNDER-REPRESENTED
POPULATIONS. I HAVE MENTIONED
WE HAVE A FOCUS ON PATIENT
REPORTED OUTCOMES IN PATIENTS
WITH USING 25 INSTRUMENTS
REFLECTING THE DOMAINS YOU SEE
HERE. OUR FIRST MANUSCRIPT DEALT
WITH MEDULLARY THYROID CANCER
WITH PATIENTS CAME FOR DECADES
WITH METASTATIC DISEASE AND
CURRENTLY ANALYZING THE PATIENT
REPORTED OUTCOME MEASURES AND
CORTICAL CARCINOMA AND
NEUROENDOCRINE TUMORS. THE NEXT
SLIDE IS AN OVERVIEW HOW WE
ANALYZE BIOSPECIMENS,
OVERWHELMINGLY WE GET PARAFFIN
EMBEDDED TISSUE, THIS IS
ANALYZED INITIALLY ACTUALLY ON
GENE MUTATION PANEL CALLED TSL
500 COLLABORATION WITH THE NCI
LAB OF PATHOLOGY. OVER A YEAR
NOW WE HAVE WHOLE EXOME
SEQUENCING AND RNA SEQUENCING
THAT IS CLIA CERTIFIED SO WE
HAVE EXPANDED WHAT WE CAN DO. WE
ARE ALSO CONDUCTING RESEARCH
CHARACTERIZATION FOR EXAMPLE DNA
METHYLATION ARRAYS AND WHOLE
GENOME SEQUENCING. FOR PATIENTS
THAT COME TO THE NIH CLINICAL
CENTER WE ALSO COLLECT
PERIPHERAL BLOOD MONONUCLEAR
CELLS FOR IMMUNE PHENOTYPING AND
CYTOKINE LEVELS. THE NEXT SLIDE
PROVIDES AN OVERVIEW OF THE
ONCOLOGY GENE PANEL. ON THE LEFT
TWO COLUMNS THE VARIANCE
IDENTIFIED MORE THAN FIVE
PATIENTS WITH ADRENAL CORTICAL
AND IDENTIFIED IN TWO PATIENTS
WITH MTC, YOU CAN SEE WE DID
IDENTIFY EXPECTED PATHOGENIC
MUTATIONS IN THESE TUMORS. ON
THE RIGHT TWO PANELS YOU SEE THE
ACTIONIBILITY TEARS AND PORTION
OF PATIENTS THAT HAVE MUTATIONS
VARY, FOR EXAMPLE FOR PORDOMA
PATIENTS WE DID NOT HAVE
MUTATIONS BUT MOST PATIENTS HAD
AT LEAST ONE PATHOGENIC
VARIATION. NEXT SLIDE. I
MENTIONED THE NIH RARE TUMOR
CLINICS ARE UNIQUE ASPECT OF
LONGITUDINAL STUDY. THESE START
WITH WILD TYPE CLINIC IN 2008
AND EXPANDED IT SINCE. WE BRING
10 TO 15 PATIENTS WITH A
SPECIFIC RARE TUMOR TO THE NIH
CLINICAL CENTER WE BRING
APPLICANTS AND CLINICIAN ACROSS
THE COUNTRY WITH EXPERTISE WITH
THESE DISEASES, PATIENTS ARE
EVALUATED AND MEET WITH THE
EXPERTS AND GET RECOMMENDATIONS.
IN 2019 WE HOSTED THE INAUGURAL
CLINIC AND SINCE CONDUCTED
CLINICS IN MEDULLARY CARCINOMA
WILL THE ADRENAL CORTICAL
CARCINOMA. THE NEXT SLIDE SHOWS
HOW THE CHORDOMA APPROACH MIGHT
BE PARADIGM HOW TO APPROACH VERY
RARE TUMOR RESEARCH, CHORDOMA
ARE LESS THAN 300 PATIENT AS
PEER PEDIATRIC CHORDOMAs ARE
LESS TAN 30 WITH DIFFERENT
BIOLOGY, MIGHT BE A CORE
DEFICIENCY. IT START WITH A
SMALL WORKING GROUP AT THE NCI
CCR AND DCEG, DEVELOP THE
NATIONAL WORKSHOP WE INVITED
APPLICANTS AND LEADERS IN THE
FIELD. WE DEVELOPED AND FORMED
PARTNERSHIPS WITH THE CHORDOMA
FOUNDATION DEVELOPED NATURAL
HISTORY STUDIES SUB PROTOCOL
SPECIFICALLY STUDY CHORDOMA HAD
THE CHORDOMA CLINIC AND
ESTABLISHED MULTI-INSTITUTIONAL
INTERNATIONAL TUMOR COHORT%
PATIENTS CAN BE REVIEWED AT ANY
TIME AND GET RECOMMENDATIONS. WE
HAVE A PEDIATRIC CHORDOMA
WORKING GROUP AND DR. REILLY AND
DR. (INAUDIBLE) FROM OREGON
HEALTH SCIENCE UNIVERSITY HAVE A
DOD GRANT TO STUDY SMART B 1
DEFICIENT TUMORS THE NEXT SLIDE
IS TRANSLATED IN A COLLABORATIVE
CLINICAL TRIAL IN COLLABORATION
WITH NCI CTEP, THE COLLABORATION
WITH PET CTN A MULTI-SITE
CLINICAL TRIAL IS DIRECTED BY --
WITH THE DEVELOPMENTAL
THERAPEUTICS CLINIC. TWO CHECK
POINT INHIBITORS FOR SMARCB 1 OR
A 4 DEFICIENT TUMORS. PATIENTS
CAN EBB ROLE IN SIX COHORT, NOT
LIMITED BY AGE, BUT YOU CAN
ENROLL PATIENTS ANY AGE AND THIS
CLINICAL TRIAL IS ONGOING. WE
ALSO MADE PROGRESS IN
PRE-CLINICAL RESEARCH
ACCOMPLISHMENTS, ANY PATIENT WHO
HAS FILED SURGERIES AT THE NIH
CLINICAL CENTER, WE WILL ATTEMPT
TO AUTOTOPPIC DERIVED PATIENT
XENOGRAPHS. AN EXAMPLE HERE OF
ADRENAL CORTICAL CARCINOMA PDX
AND SINGLE CELL SEQUENCING IN
THESE TUMORS AND COMPARED THE
PRIMARY TUMOR AND THE MOUSE
TUMOR AS WE SEE HERE, THESE
TUMORS EXPRESS SIMILAR MARKERS.
IN COLLABORATION WITH DR.
(INDISCERNIBLE) WE ALSO HAVE
EMBARKED ON ESTABLISHING A
GENETICALLY ENGINEERED MOUSE
MODEL OF WILD TYPE. THERE ARE NO
PRE-CLINICAL MODELS TO STUDY
WILD TYPE JIST FOR THIS TUMOR
KNOCK OUT SBHV AND ACTIVATE BRAF
WHICH RESULTS IN TUMORS SIMILAR
TO WHAT WE SEE IN GIST AND
SOMEWHAT REFINEMENT WE HOPE THIS
WILL BE A USEFUL TOOL FOR A STEP
FORD FOR PRE-CLINICAL TESTING.
WE ARE VALIDATING THESE MODELS
AND WILL MAKE THEM PUBLICLY
AVAILABLE AS SOON AS WE CAN.
NEXT SLIDE OUR COMMITMENT TO
ENGAGEMENT AND DEE
ACCOMPLISHMENTS. WE HAVE
ESTABLISHED 29 ADVOCACY
PARTNERSHIPS. WE HAVE A WEBSITE
WITH INFORMATION AND RESOURCES
CENTERED ON PATIENTS AND
CAREGIVERS. WE HAVE AN ENGLISH
AND SPANISH VERSION OF THIS AND
HAVE APPROXIMATELY 70,000 UNIQUE
VISITORS PER MONTH. WE ALSO HAVE
PRESCRIBERS TO (INAUDIBLE)
LETTER AND HAVE PARTICIPANTS WHO
FOLLOW OUR POB AND TWITTER
FEEDS. I WOULD LIKE TO HIGHLIGHT
THE NEXT SLIDES A FEW LESSONS WE
LEARNED FROM MYPART. ADVOCACY
AND CLINICAL AND SCIENTIFIC
RITUAL EXPERTISE, DISEASE
CHAMPIONS, ARE CRITICAL FOR
MAKING PROGRESS. I BELIEVE
STRONGLY THE NIH RARE TUMOR
CLINICS PROVIDE INSIGHT WE COULD
NOT GET THROUGH EVALUATION OF
SINGLE PATIENTS AT DIFFERENT
SITES. IT IS RESOURCE AND TIME
INTENSIVE TO THE -- MUCH OF THE
MEANINGFUL COHORT. AND I BELIEVE
THEY HAVE TO FOCUS ON SELECTION
WILD TYPES TO ACCRUE SUFFICIENT
NUMBERS OF PATIENTS. AND FROM
THIS RESULT THE DESIRE TO
DEVELOP PARTNERSHIP WITH
CONSORTIA, THE COG COMMUNITY
HOSPITALS AND ADVOCACY AND
NATIONAL EXPERTS TO ACCELERATE
THIS PROGRESS AND WE WORK HARD
WITH THE NCI CCDI AND OTHERS TO
DEVELOP A COLLABORATIVE NATIONAL
STRATEGY THAT PROVIDES THE
INFRASTRUCTURE TO EFFICIENTLY
STUDY DIFFERENT TUMORS AT THE
SAME TIME. I'M GIVING YOU A
BRIEF OVERVIEW OF THIS EFFORT ON
THE NEXT SLIDE. WE HAVE
PRESENTED AND DR. -- THE
SCIENTIFIC DIRECTOR OF THE CCDI
ON THIS BIG EFFORT WHICH I WANT
TO EMPHASIZE IS REALLY A
NATIONAL EFFORT AND THE BSA
PROVIDED MUCH INSIGHT AND ADVICE
AND GUIDANCE AS TO HOW THE CCDI
SHOULD BE ROLLED OUT. FOR TODAY
I WOULD LIKE TO BRIEFLY
HIGHLIGHT THE MOLECULAR
CHARACTERIZATION INITIATIVE AND
THE NATIONAL RARE TUMOR
INITIATIVE NCI IS THE
PARTNERSHIP BETWEEN THE NCI AND
THE CHILDREN'S ONCOLOGY GROUP
PROJECT THE SCREENING PROTOCOL
OF COG. WHAT CCDI PROVIDES IN
LA RATION WITH COG IS STATE OF
THE ART MOLECULAR
CHARACTERIZATION TO NEWLY
DIAGNOSED PATIENTS WHO ENROLL IN
PROJECT EVERY CHILD. ROLLED OUT
FOR CNS TUMOR FIRST, THEN SOFT
TISSUE SARCOMA AND RARE CANCER.
THE GOAL IS NOT DOING THIS FOR
NEWLY DIAGNOSED BUT ALSO FOR
REFRACTORY TUMORS. RESULTS ARE
RICHER PHYSICIANS AND
PARTICIPANTS IN 21 DAYS. WHAT
THIS ALLOWS IS TO IDENTIFY NOT
ONLY RARE TUMORS BUT MOLECULAR
SUBTYPES THAT POTENTIALLY ENROLL
IN THE NATIONAL INITIATIVE.
SINCE INITIATION OF THIS EFFORT,
MORE THAN 3,000 PARTICIPANTS
HAVE BEEN ENROLLED WHICH IS
REALLY IMPRESSIVE. THE NEXT
BRIEFLY SHOWS TO YOU HOW WE
ENVISION TO COORDINATE THIS AND
PATIENTS CAN BE IDENTIFY EVERY
CHILD (INAUDIBLE) HOPE TO ENGAGE
OTHER CONSORTIA AND COMMUNITY
HOSPITALS TO REACH ENROLLMENT.
PATIENTS UNDERGO STANDARDIZED
CLINICAL CHARACTERIZATION THAT
MOLECULAR CHARACTERIZATION WILL
BE DONE THROUGH THE NCI.
RESEARCH GRADE SEQUENCE WILL BE
CONDUCTED IN COLLABORATION WITH
THE DISEASE EXPERTS. PATIENTS
WANTED AND FOLLOW -- MONITORED
AND FOLLOWED LONGITUDINALLY, ALL
DATA GOES INTO CCI DATA
ECOSYSTEM. THE NEXT SLIDE SHOWS
WHILE THIS IS AN NCI CCDI
COORDINATED EFFORT, WE HOPE THIS
IS INFRASTRUCTURE THAT IS
CONDUCTED CAN BE UTILIZED BY
DISEASE FROM ANY PLACE IN THE
U.S. AND HOPEFULLY
INTERNATIONALLY. SO THAT
PARTICIPATING EFFORTS CAN JOIN
THIS EFFORT AND NEW RARE TUMORS
CAN BE STUDIED THROUGH THIS
EFFORT AS WELL. THIS IS ALSO AS
I HAVE SHOWN ALIGNED WITH THE
EFFORTS OF CC DIRECT. WE HOPE
EVERY PATIENT WILL GOAL A
CORRECT TIMELY DIAGNOSIS,
APPROPRIATE MOLECULAR PROFILING
AS NEEDED, RECOMMENDATIONS TO
INTERNATIONAL AND NATIONAL TUMOR
BOARD, PATIENT NAVIGATION AND
PORTABLE HEALTH RECORD MAKES
LONGITUDINAL MONITORING AND
TRIAL PARTICIPATION EASIER AND
ULTIMATELY WHERE WE CAN GET
MEANINGFUL EXTERNAL CONTROLS FOR
SPECIFIC RARE TUMORS. THANK YOU
VERY MUCH. DR. REILLY WILL TAKE
OVER FROM HERE.
>>RECOGNIZING UNIQUE CHALLENGES
OF DRUG DEVELOPMENT FOR RARE
TUMORS WE PROPOSE A NEW PROGRAM
AIMED AT DRUG DEVELOPMENT FOR
RAREST OF TUMORS. WE BEGAN
DISCUSSION OF THE PROJECT IN
WINTER OF 2022, AND SHOW AS
MODEL THE FOUNDATION FOR NIH
WILL BRING TOGETHER STAKEHOLDERS
IN PARTNERSHIP WITH NCI NCATS
AND THE FDA. ON AUGUST 24 WE
HELD A PUBLIC STAKEHOLDER
MEETING FOR FEEDBACK FROM THE
COMMUNITY ON THE PROPOSAL. THIS
WAS WELL ATTENDD BY STAKEHOLDERS
FROM INDUSTRY, ACADEMIA, AND
ADVOCACY AMONG OTHERS. SO
THERE'S NO AGREED UPON
DEFINITION OF RARE TUMORS AT
THIS TIME HOWEVER THERE ARE
SOURCES OF INFORMATION TO DRAW
UPON. CTOS PUBLISHED A WORKING
GROUP REPORT IN 2021 DEFINING
ULTRA RARE SAW SATISFY CO-A MA
INCIDENCE LESS THAN ONE IN A
MILLION BASED ON DIFFICULTY OF
CONDUCTING WELL POWERED
PROSPECTIVE TRIALS. WORK BASED
IN EUROPE PROVIDES SOME OF THE
MOST COMPREHENSIVE INFORMATION
ON RARE DISEASES AND DEFINES THE
RAREST INCIDENCE AS LESS THAN 1
IN A MILLION. SO BASED ON THE
CURRENT U.S. POPULATION, THIS
WORKS OUT TO APPROXIMATELY 340
NEW CASES IN THE U.S. PER YEAR.
TO GET A BACK OF THE ENVELOPE
CALCULATION OF THE SCOPE OF
ULTRA RARE TUMORS I PROVIDE DATA
FROM CTOS ON THE ODE OF 200
ULTRA RARE TUMORS IDENTIFIED
WHICH AT LEAST 60 HAVE A
CHARACTERISTIC MOLECULAR
ALTERATION. SUCH ESTIMATED
75,000 PATIENTS IN H THE U.S.
ARE AFFECTED BY ULTRA RARE
TUMOR. BECAUSE THIS IS PRIMARILY
BASED ON DATA FROM THE EUROPEAN
GROUP MORE WORK IS NEEDED TO GET
ACCURATE ESTIMATE OF ULTRA RARE
TUMORS IN THE US. MOST OF THE
MOLECULAR ALTERATIONS ARE UNIQUE
TO SMALL NUMBER OF RARE TUMORS
BUT ARE ALSO FOUND IN MORE
COMMON CANCER. AMONG THE
PARTICIPANTS OF THE MY PART
NATIONAL HISTORY STUDY AS OF
SEPTEMBER 1, 43% HAVE ULTRA RARE
TUMOR DIAGNOSIS. THE PROPOSED
PARTNERSHIP RESTS ON SEVERAL
PRINCIPLES. FIRST DESPITE THE
SMALL NUMBER OF EFFECTIVE
PATIENTS EACH IS DESERVING
CURATIVE THERAPIES. SEW THOUGH
ULTRA RARE TUMOR DRUG
DEVELOPMENT MAYBE MORE DIFFICULT
AND COSTLY THAN FOR COMMON
CANCER WE OWE IT TO PATIENTS TO
FIND SOLUTIONS TO THE
CHALLENGES. MAJOR CHALLENGES AS
WE SEE THEM, ARE THE LACK OF
ECONOMIC FEASIBILITY OF
DEVELOPING DRUGS IN THE PRIVATE
SECTOR. WHICH LEADS TO DRUG
DEVELOPMENT WITH ADVOCACY
ORGANIZATIONS AN ACADEMIC
RESEARCHERS UNLESS THE DRUG
REPURPOSED FROM OTHER
INDICATIONS. DRUGS THAT MIGHT
WORK SPECIFICALLY IN ULTRA RARE
TUMORS ARE NOT TESTED OR DROPPED
DUE TO ECONOMIC INCENTIVE AND
TARGETS SPECIFIC TO ULTRA RARE
TUMORS MAY NOT BE ADEQUATELY
PURSUED. BECAUSE OF THE
DIFFICULTY DEVELOPING DRUGS IN
THE PRIVATE SECTOR WE BELIEVE
THE GOVERNMENT PLAYS AN
IMPORTANT ROLE IN REDUCING COSTS
TO INDUSTRY AND DERISKING
PROJECTS FOR ULTRA RARE TUMOR
INDICATIONS. THE AIM OF THE
PROPOSAL IS HARNESS STATE OF THE
ART TECHNOLOGIES TO TARGET WELL
ESTABLISHED PREVIOUSLY
UNDRUGGABLE BIOLOGICAL
VULNERABILITIES OF ULTRA RARE
CANCER THAT LACK COMMERCIAL
INCENTIVE FOR DRUG DEVELOPMENT,
THROUGH OPEN SCIENCE
MULTI-STAKEHOLDER PUBLIC PRIVATE
PARTNERSHIP. WE PLAN TO FOCUS ON
DEFINING BIOLOGY OF ULTRA RARE
TUMORS TO IDENTIFY POTENTIAL
DRUGGABLE TARGETS. COMPARING
DIFFERENT PLATFORMS TO TARGET
DRUGS TO THE TUMOR BIOLOGY.
DEVELOPING OPEN SCIENCE PROCESS.
SO ALL STAKEHOLDERS LEARN FROM
DECISIONS MADE AND RESOURCES
AVAILABLE. CHAMPION DRUG
DEVELOPMENT FROM CONCEPT TO
CLINICAL TRIAL. NIH WILL PROVIDE
GOVERNANCE AND OVERSIGHT FOR
PARTNERSHIP FACILITATING ACTIONS
WITH GOVERNMENT AND OTHER
STAKEHOLDERS. F NCI NIH WAS
ESTABLISHED TO FORM BRIDGES
BETWEEN MINI AND OTHER ENTITIES
-- NIH AND HELP MANY OTHER
FUNCTIONS NEEDED FOR SUCCESS. WE
ENSIX CYCLE OF DRUG DEVELOPMENT
REITERATED FOR ULTRA RARE
TUMORS. IN THE INITIAL PILOT
PHASE, INFRASTRUCTURE IS BUILT
USING ONE TO TWO ULTRA RARE
TUMORS WITH KNOWN AND UNDRUGGED
DRIVER MUTATIONS. WORKSHOP WILL
BE CONVENED WITH DISEASE EXPERTS
AND STAKEHOLDERS TO ANALYZE
TUMOR BIOLOGY AND IDENTIFY
PROMISING DRUG DEVELOPMENT
APPROACHES. WITH THE HELP OF F
NIH WE DEVELOP COLLABORATION AND
IP AGREEMENTS, ESTABLISH A
STEERING MANY I AND SCIENTIFIC
ADVISORY BOARD AND SET UP
INFRASTRUCTURE FOR OPEN NOTEBOOK
PLATFORM. ONCE THE TARGETING
APPROACHES ARE DECIDED ON,
RESEARCHERS FROM ACROSS
GOVERNMENT ACADEMIA AND INDUSTRY
WILL BE LEVERAGED TO DEVELOP
CANDIDATE DRUGS AND EARLY PHASE
CLINICAL TRIALS WILL BE
INITIATED. IMPORTANTLY
SUSTAINABILITY PLAN IS DEVELOPED
TO ENSURE SUPPLY OF DRUGS TO
PATIENTS LONG TERM. EITHER
THROUGH FOR PROFIT OR NOT FOR
PROFIT MECHANISM DEPENDING ON
CANDIDATE DRUG AND DISEASE.
AFTER THE INITIAL PILOT OUR GOAL
IS BEGIN NEW CYCLES ONE TO TWO
YEARS WITH ULTRA RARE TUMORS AN
TARGETS WITH EACH COMMUNITY. THE
SCIENTIFIC ADVISORY BOARD HAVE
FINED WITH THE APPROPRIATE
EXPERTS AND THE OPEN DATA
PLATFORM WILL ELIMINATE DECISION
MAKING PROCESS, PARTICULARLY
WITH REGARDS TO THE FDA. TO
PROVIDE VALUE -- ADDED VALUE TO
ALL RARE TUMOR DRUG DEVELOPERS.
SO WITHIN OUR NIH ALPHABET SOUP,
MANY PROGRAMS ALREADY EXIST THAT
CAN BE HARNESSED FOR COMPOUND
IDENTIFICATION AND OPTIMIZATION.
PRE-CLINICAL TESTING,
UNDERSTANDING THE NATURAL
HISTORY AND MOLECULAR DRIVERS.
AS DR. WIDEMANN PRESENTED, FIRST
IN HUMAN TRIALS AND COOPERATIVE
TRIAL NETWORKS. SO THROUGH OUR
DISCUSSIONS WITH MANY
STAKEHOLDERS OVER THE PAST YEAR,
WE HAVE CLARIFIED THE FOLLOWING.
THE PARTNERSHIP WILL FOCUS ON
ULTRA RARE TUMORS WITHIN
ADEQUATE THERAPIES, WELL
ESTABLISHED UNDRUGGABLE
MOLECULAR TARGETS CHARACTERISTIC
OF THE TUMOR. COLLABORATION AND
IP AGREEMENTS TO PROMOTE DRUG
DEVELOPMENT, REGULATORY
APPROVAL, AND SUSTAIN DRUG
SUPPLY FOR PATIENTS. A
TRANSPARENT OPEN SCIENCE
PARADIGM THAT WORKS ACROSS
GOVERNMENT ACADEMIA AND
INDUSTRY. AND BRINGING TOGETHER
CHAMPIONS FOR THE ULTRA RARE
TUMOR, BIOLOGICAL MECHANISMS AND
TARGETING TECHNOLOGY. THE
PARTNERSHIP IS NOT INTENDED TO
COMPETE WITH OTHER DRUG
DEVELOPMENT PROGRAMS FOR ULTRA
RARE OR RARE TUMORS. OR TO
FOCUS ON TUMOR AGNOSTIC
THERAPIES, IMMUNOTHERAPY, THESE
MAYBE MORE ABLE TO BE DEVELOPED
COMMERCIALLY. WE DON'T PLAN TO
FOCUS ON ULTRA RARE TUMORS
CHARACTERISTIC BIOLOGY HAS NOT
BEEN IDENTIFIED. AS PART OF
FEEDBACK WE IDENTIFIED THEMES
FOR ELEMENTS OF SUCCESS. SUCCESS
WILL LIKELY REQUIRE STRONG
EFFECTIVE GOVERNANCE TO KEEP
PROJECTS MOVING FORWARD QUICKLY
FOCUSING ON A SMALL NUMBER OF
NEW TUMORS EACH YEAR WHILE
DEVELOPING INFRASTRUCTURE TO
MOVE THROUGH THEM QUICKLY TO
ADDRESS AS MANY ULTRA RARE
TUMORS AS POSSIBLE. DEVELOPING
TEAMS OF CHAMPIONSNA MAY TURN
OVER WITH EACH NEW ULTRA RARE
TUMOR: AND ESTABLISHING
COLLABORATION AND IP AGREEMENTS
THAT WILL REQUIRE MINIMUM
RENEGOTIATION AT EACH ITERATION
AND PRESERVE COMMERCIALIZATION
STRATEGIES AS WELL AS GOVERNMENT
MARCHING RIGHT OF THE PRIVATE
COMMERCIALIZATION SOLUTION IS
NOT ECONOMICALLY FEASIBLE. OPEN
NOTEBOOK STRATEGIES THAT WILL
BENEFIT ALL RESEARCHERS WHILE
PRESERVING TRADE SECRETS AND IP
TO ALLOW INDUSTRY AND ACADEMIC
INSTITUTIONS WITH LICENSING
INTEREST TO PARTICIPATE.
HARNESSING EXISTING GOVERNMENT
AND PRIVATE SECTOR RESOURCES TO
MOVE THROUGH THE STEPS OF DRUG
DEVELOPMENT AND DEVELOPING
INCENTIVES FOR INDUSTRY
PARTICIPATE INCLUDING USE FROM
THE FDA. WE NEED TO.
COUP WITH INNOVATIVE STRATEGIES
TO CREATE SAFER ENVIRONMENTS FOR
INDUSTRY TO SHARE COMPOUNDS AND
HIGH RISK PROJECTS FOR ULTRA
RARE TUMORS WITHOUT JEOPARDIZING
THE MAIN INDICATIONS. AND WE
NEED TO DEVELOP SUSTAINABILITY
STRATEGIES MAKING DRUGS
AVAILABLE TO PATIENTS WITH RARE
TUMORS LONG TERM. IN ADDITION TO
TO CUSSING ON ULTRA RARE TUMORS
WITH LIMITED NEED WELL DEFINED
MOLECULAR DRIVERS PRIORITIZATION
IS WELL CHARACTERIZED
EXPERIMENTAL MODEL SYSTEMS FOR
CLINICAL TESTING, COMMITTED AT
SLOW KATES ACT AS LIAISONS TO
THE PATIENT COMMUNITY. CLINICIAN
CHAMPIONS WILLING TO LEADS EARLY
PHASE CLINICAL TRIALS AND
COMMITTED RESEARCHERS WITH
EXPERTISE IN BIOLOGICAL TARGETS
WITH INNOVATIVE TECHNOLOGICAL
APPROACHES WILLING TO COMMIT TO
RAPID DRUG OPTIMIZATION. DRUG
DEVELOPMENT APPROACHES TO
IDENTIFY TREATMENT ASPECT OF
PROPOSAL CAN BENEFIT ALL CANCER
PATIENTS. RARE TUMOR
RESEARCHERS MUST COLLABORATE TO
BE SUCCESSFUL THIS MAY DERIVE
CREATIVE SOLUTIONS TO IP AND
COLLABORATION BARRIERS THAT
COULD BE ADOPTED MORE BROADLY.
THE STUDY OF RARE TUMORS
INFORMED HALLMARK FEATURES OF
CANCER AND DRUG DEVELOPMENT FOR
ULTRA RARE TUMORS AND THIS MAY
YIELD INSIGHTS FOR CANCER
TREATMENT. AS COMMON CANCER
BECOME DEFINED BINARY ROW
SUBTYPES THE PATHWAYS TO DRUG
DEVELOPMENT AND REGULATIVE
APPROVAL IN RARE TUMORS MAY
BECOME BROADLY APPLICABLE. WE
BELIEVE THIS PROPOSAL CAN
ADDRESS UNMET NEED IN ULTRA RARE
TUMORS WHILE DEVELOPING
PARADIGMS AND INCENTIVES FOR
DRUG DEVELOPMENT. IN SUMMARY AS
DR. WIDEMANN PRESENTED THE MY
PART NETWORK FOR RARE TUMOR
RESEARCH IS SUBSTANTIAL PROGRESS
FOR ENGAGE REGULAR SEARCHERS AND
ADVOCACY GROUPS TO STUDY RARE
TUMORS, MY PARTNERSHIP IS A
STRONG FOUNDATION AND FOR
COLLECTION AND ANALYSIS OF RARE
TUMORS FROM THE NIH CLINICAL
CENTER. WE DEVELOPED
COLLABORATIVE PEDIATRIC ADULT
INTERVENTION TRIALS AND CONTINUE
TO LOOK FOR COLLABORATION
OPPORTUNITIES. FOR EXAMPLE BENCH
TO BEDSIDE AND UO 1
OPPORTUNITIES WITH EXTRAMURAL
RESEARCHERS. MY PART IS PLAYING
A KEY ROLE ESTABLISHING NATIONAL
PROGRAM FOR RARE TUMOR RESEARCH
IN COLLABORATION WITH CCDI AND
FDA. WE WOULD LIKE THE THANK
THE MEMBERS OF MY PART TEAM PAST
ANT PRESENT AS WELL AS OUR
PARTNERS IN THE INTRAMURAL
RESEARCH PROGRAM INSTITUTE. WE
APPRECIATE THE COLLEAGUES FOR
COLLABORATIONS ADVICE AND
HELPFUL DISCUSSIONS, IN
PARTICULAR THESE INDIVIDUALS
DEVELOPING PLANS FOR THE CCDI
NATIONAL COHORT STUDY, AND THE
PUBLIC PRIVATE PARTNERSHIP. MOST
IMPORTANTLY WE WANT TO THANK
ADVOCACY PARTNERS AND PATIENTS
WITH CAREGIVERS AND FAMILY
MEMBERS WHO CONTRIBUTED TO THE
MY PART STUDY. WITH THAT WE CAN
TAKE QUESTIONS.
>>THANK YOU SO MUCH, DOCTORS
REILLY AND WIDEMANN. WE CAN OPEN
THE FLOOR FOR QUESTIONS.
RICHARD, IF YOU HAVE A QUESTION
PLEASE USE THE TOOL AT BOTTOM
THAT WAY I CAN -- GO AHEAD
RICHARD.
>>THANK YOU. THE ONLY QUESTION
I HAVE IS WHETHER THERE'S
CONSIDERATION FOR IMPROVING OR
MITIGATING THE LIABILITY
INSURANCE ISSUES WITH CREATING
NEW MEDICATIONS FOR RARE TUMORS
>>I THINK THIS IS SOMETHING
CERTAINLY BROUGHT UP MANY TIMES.
I DON'T KNOW NCI IS NECESSARILY
IN THE POSITION TO SOLVE THE
PROBLEM BUT I THINK DEFINITELY
WE NEED TO LOOK FOR CREATIVE
SOLUTIONS. LOOKS LIKE MONICA
MIGHT HAVE A RESPONSE TO THAT
TOO.
>>MONICA, DID YOU HAVE A
COMMENT OR ADDITIONAL QUESTION?
>>NO, THANK YOU. I WANTED TO
SAY FIRST THANK YOU BRIDGETTE
AND CAROLYN FOR PRESENTING THIS.
I WANTED TO LET EVERYONE KNOW
THIS IS ONE EXAMPLE, WHEN YOU
LOOK AT THE PUBLIC INVESTMENT IN
THE NCI INTRAMURAL PROGRAM, WE
WANTED TO SHOW THIS BECAUSE IT
IS ONE OF MANY EXAMPLES OF WHERE
OUR GOAL FOR THE INTRAMURAL
PROGRAM IS TO DO THINGS THAT
AUGMENT THAT CAN'T BE DONE IN
THE EXTRAMURAL COMMUNITY THAT
BRING VALUE TO EVERYBODY, THAT
DON'T FORM A POINT OF
COMPETITION WITH THE EXTRAMURAL
COMMUNITY BUT RATHER A SYNERGY.
SOMETHING WE CAN UNIQUELY OFFER.
I THINK THE CLINICAL CENTER IS A
TREMENDOUS RESOURCE AND SO THIS
IS JUST ONE OF MANY EXAMPLES WE
CAN GIVE YOU OF OUR APPROACH TO
THE INTRAMURAL PROGRAM AND HOW
IT CAN REALLY BE COMPLIMENTARY
TO WHEREVER ELSE WE PUT OUR
FUNDING.
>>GREAT.
>>I GUESS I DO HAVE A QUESTION
IN TERMS OF IF WE LOOK AT RARE
CANCER, IS THERE A SPECTRUM OF
THOSE THAT TEND TO PRESENT
AGGRESSIVELY AND HAVE MUCH
HIGHER MORTALITY RATES VERSUS
THOSE THAT ARE -- CAN BE A BIT
MORE MANAGEABLE IF DIAGNOSED
EARLY -- AND SO HOW ARE YOU
PRIORITIZING YOUR AREAS OF FOCUS
AND INTEREST?
>>I THINK THERE IS -- THAT IS
AN EXCELLENT QUESTION. ONE OF
THE LIMITATIONS THAT WE HAVE FOR
PATIENTS TO COME UP TO THE NIH
CLINICAL CENTER LONGITUDINALLY,
THE AGGRESSIVE CANCERS WHERE WE
DON'T HAVE ANYTHING TO OFFER AS
RELATES TO TREATMENT, WILL BE
DIFFICULT. AND I THINK THIS IS
ONE OF THE PRIME EXAMPLES WHERE
IT WOULD BE WONDERFUL TO
COLLABORATE WITH MEMORY OR WITH
A SITE THAT TREATS AGGRESSIVE
CANCER OR BOSTON CHILDREN'S
WHERE WE KNOW THAT IS THE
SURGICAL EXPERTISE OR OTHER
EXPERTISE WHERE THE SAME DATA
ELEMENTS, CLINICAL DATA ELEMENTS
WE USE THE INFRASTRUCTURE CAN BE
USED BUT EXPERTISE COMES FROM
THE DISEASE (INAUDIBLE) AT THIS
SPECIFIC SITE. ONCE WE HAVE A
CLINICAL TRIAL INTERVENTIONAL
TRIAL THEN IT CHANGES. THEN WE
CAN GET PATIENTS TO COME TO THE
NIH CLINICAL CENTER AND OTHER
SITES. BUT TO REALLY MAKE
PROGRESS ON THE VERY AGGRESSIVE
CANCERS WE NEED THE
COLLABORATION WITH THE
EXTRAMURAL PARTNERS AND WE HOPE
THIS INFRASTRUCTURE THAT WILL BE
CREATED THROUGH THE CCDI CAN BE
UTILIZED AND FACILITATE ENABLE
THE RESEARCH DIFFICULT TO DO
OTHERWISE. AT EXTRAMURAL SITES.
T
>>ONE THING I WANT TO ADD, YOU
TALKING ABOUT EARLY DETECTION
AND PREVENTION TO MAKE THESE
THINGS EASIER TO WORK WITH. FROM
SO MANY RARE TUMORS THERE IS NOT
THE KNOWLEDGE BASE THERE. AND
THERE ISN'T THE FAMILIARITY IN
THE COMMUNITY. SO WHAT WE FIND
IS THAT THE DIAGNOSTIC ODYSSEYS
FOR THESE PATIENTS IS VERY LONG
AND USUALLY DIAGNOSED LATE AND
USUALLY DIAGNOSED MUCH HIGHER
LEVEL AGGRESSIVENESS THAN
NECESSARY. SO I THINK THAT IS
ONE OUR GOALS IS TO BE
DISSEMINATING THE INFORMATION SO
THAT THIS BECOMES MORE
RECOGNIZED PAPPED TUMORS CAN BE
CAUGHT EARLIER AND WE CAN FOCUS
ON THE ONES THAT ARE MUCH MORE
AGGRESSIVE.
>>ANOTHER FASCINATING ASPECT I
THINK OF SOME OF THESE PEDIATRIC
AND AYA CANCERS IS YOU DO HAVE
THOSE THAT ARE DRIVEN BY FOR
INSTANCE BETA CATENIN, THINGS
MORE ONCOGENIC, VERSUS SORT OF
ALTERATIONS THAT PROCURE
PROCESSES THAT ARE MORE
DEVELOPMENT AND DIFFERENTIATION.
SO HOW ARE YOU STRATIFYING THE
WHOLE CONCEPT OF PRIORITIZATION,
RIGHT? BECAUSE THE BIOLOGICAL
PROCESS IS THAT DRIVER CANCER
DIFFERENT WHICH DRIVES
APPROACHES TO TREATMENT THAT CAN
BE DIFFERENT.
>>THAT IS ABSOLUTELY RIGH RIGHO
YOU WANT TO RESPOND TO THAT
FIRST?
>>IT IS THE PRIORITIZATION
COULD BE WHERE THE GREATEST
UNMET NEED. BUT WHICH I THINK
WOULD BE STILL FAIR TO DO. I
FEEL FOR SUCCESS IF WE KNOW OF
DISEASE CHAMPIONS WE KNOW OF
PEOPLE WHO ARE ALREADY INVESTED
BUT WE HAVE NOT HAD THE ABILITY
TO RECRUIT MEANINGFUL COHORT,
THAT IS WHERE I WOULD GO. FOUR
AREAS WE BEGIN TO UNDERSTAND THE
BIOLOGY AND MIGHT BE CLOSE, I
WOULD ALSO GO, I THINK IT IS A
GREAT QUESTION HOW WE
PRIORITIZE, IN MY MIND HAVING
SOMETHING TRUTHFULLY COMMITTED
AND GOING ALL THE WAY FOR EVERY
PATIENT TO ALLOW US TO HOPEFULLY
THE GREATEST PROGRESS.
>>COLLEAGUES THAT WE ARE
WORKING ON WITH THIS ARE MOST
INTERESTED IN THE IDEA THAT
THERE -- THAT PEOPLE DON'T KNOW
ABOUT EACH OTHER. THERE MAYBE
TECHNOLOGIES THAT COULD BE
APPLIED TO SOME OF THESE FUSIONS
WHERE WE KNOW THAT IT IS
IMPORTANT TUMOR BUT IT HASN'T
HAD THE RIGHT TECHNOLOGY APPLIED
TO IT. SO THAT'S ONE OF THE
GOALS OF THIS PUBLIC PRIVATE
PARTNERSHIP IS TO REALLY BE ABLE
TO TRY AND APPLY NEW
TECHNOLOGIES.
>>GREAT. I THINK I SAW
HOWARD'S HAND FIRST, THEN ANN
BARKER. HOWARD.
>>THANK YOU, VERY MUCH FOR
DOING THIS. AND THE EFFORTS.
COMING FROM INDUSTRY, I HAVE
SEEN THE -- A LOT OF
MISPERCEPTIONS THAT SEEM THE
LEAD TO BARRIERS TO DECISION
MAKING WORKING ON UN-- ON RARE
TUMORS. SOME OF THEM HAVE TO DO
WITH HISTORIC BARRIERS TO -- FOR
IP, ET CETERA. COULD YOU SHARE
YOUR THOUGHTS ON THIS AND YOU
SEE WAYS THAT YOUR
COLLABORATIONS, ARE WITHIN ON
THE LEGAL SIDE, ALL THESE SIDES,
ARE GOING TO HELP MITIGATE
THESE, AND HELP ADVANCE INDUSTRY
SPONSORS TO SEEK OUTS MORE
COLLABORATIONS WITH YOU ALONG
THE LINES OF WHAT WE HEARD ABOUT
FOR THE SOFT TISSUE SARCOMA
WORK?
>>YEAH, ONE OF THE HOPES IS THE
OPEN NOTEBOOK PROCESS WOULD
DISPEL SOME OF THE PRE-CONCEIVED
NOTIONS, THAT WE DON'T WANT
INDUSTRY DECIDING NOT TO
PARTICIPATE BECAUSE THEY ASSUME
THAT THE FDA WILL SHUT DOWN THE
IDEAS UP FRONT. SO THE IDEA IS
THAT THERE WILL BE THIS RECORD
OF HOW THE FDA MADE ITS DECISION
MAKING PROCESSES THAT CAN THEN
REFER BACK TO AND REALLY PEOPLE
CAN SEE A WAY FORWARD. TOWARDS
DOING THESE KINDS OF THINGS. WE
ACKNOWLEDGE THERE WILL BE CASES
WHERE THERE IS NO FINANCIAL
INCENTIVE FOR INDUSTRY. THERE
WON'T BE ENOUGH PATIENTS AND IT
JUST WON'T WORK. THAT'S WHERE
THE GOVERNMENT I THINK NEEDS TO
STEP IN. BECAUSE IF WE CAN CURE
EVERYONE WITH THE SAME
IMMUNOTHERAPY WE DON'T NEED THIS
PROGRAM. SO I THINK REALLY THE
IDEA IS TO TRY AND FOCUS ON
THINGS WHERE IT WON'T HAPPEN ON
ITS OWN. AGREE, A HUGE PART OF
THIS PROGRAM WILL BE GETTING THE
IP RIGHTS, RIGHT UP FRONT. SO I
THINK THAT THAT WILL BE A BIG
PART OF IT. IS TO GET CREATIVE
ON IT.
>>RIGHT P.
>>QUICK COMMENT. DRUG DISCOVERY
AT THE NCI GOES BACK TO THE
1970s AND WE WERE FIRST IN
CLASS IN TERMS OF EVEN FIGURING
OUT WHO MAKES THOSE DRUGS AND WE
LEARNED A LOT, WE STILL HAVE A
VERY POWERFUL I THINK MAYBE THE
MOST POWERFUL DRUG DISCOVERY
DEVELOPMENT ACTIVITIES OF ANY OF
THE INSTITUTES OR ANYWHERE ELSE
ACTUALLY. SO I'M BONDING ARE HOW
MUCH OF THAT KNOWLEDGE CAN YOU
LEVERAGE? WHEN YOU GET -- THE
DISCOVERIES WILL LEAD TO
DISCOVERIES, THAT IS GREAT BUT
AFTER THAT ALL BECOMES HOW YOU
DEVELOP THIS TARGET HOW YOU
DEVELOP THIS. I LOVE THE IDEA OF
INDUSTRY BEING ENGAGED. I'M NOT
REALLY OPTIMISTIC YET THAT I
WILL PICK HEM UP AN RUN WITH
THEM. I WORK IN GBN A LOT AND
THAT IS WHAT THEY TELL YOU, THEY
DON'T WANT -- THEY WANT TO HELP
YOU BUT NOT WITH WARE DRUG. SO
HOW MUCH CAN YOU LOVE WHAT WE
ALREADY KNOW HOW TO DO AND THEN
WHAT SPECIFICALLY ARE YOU GOING
TO DO TO ENTICE THE INDUSTRY
INTO THIS SPACE? I WOULD LOVE TO
SEE IT. WE FOUGHT THIS BATTLE
FOR A LONG TIME.
>>I ABSOLUTELY AGREE WITH YOU.
THERE ARE MANY PROGRAMS AT OUR
STAKEHOLDER MEETING WE HEARD
FROM SOME PEOPLE INVOLVED IN
CHEMICAL BIOLOGY OPTIMIZATION,
THERE'S THE NEXT PROGRAM. WE
HEARD FROM SOMEONE ELSE ABOUT
THAT. I THINK ALL OF THESE WE
NEED TO TAKE ADVANTAGE OF THE
EXPERIENCE DEVELOPED THERE. AND
IN TERMS OF ENTICING INDUSTRY, I
THINK IT IS STILL AN OPEN
QUESTION. IT MAY BE THE KIND OF
THING WHERE WE NEED TO RELY ON
THIRD IN CLASS DRUGS BEING PUT
FORWARD OR ALLOWING THINGS TO GO
INTO CHILDREN WHERE THEY HAVEN'T
BEEN IN CHILDREN BEFORE. WE ARE
GOING TO NEED TO BE CREATIVE IN
TERMS OF THESE THINGS. I THINK
IT IS FRUSTRATING WHEN YOU THINK
OF SOMETHING LIKE SOME OF THESE
FUSIONS IDENTIFIED FOR DECADES
AND DECADES. IS THERE'S BEEN NO
SUCCESSFUL APPROACHES YET SO ONE
OF THE THINGS WE HOPE IS THAT
THERE ARE GOING TO BE TECHNOLOGY
FIRMS THAT MAYBE AREN'T IN THE
ONCOLOGY SPACE THAT WILL BE
INTERESTED IN TESTING OUT SOME
OF THE TECHNOLOGIES. THAN
THROUGH PARTNERSHIP, BEING ABLE
TO USE RESOURCES AND NCATS AND
NCI TO REALLY REDUCE THEIR COST
OF DRUG DEVELOPMENT. HOPEFULLY
COME UP WITH WAYS TO PROVIDE
DRUG LONG TERM TO PATIENTS
BECAUSE THAT IS THE BIG
QUESTION, WE HAD SOME PEOPLE AT
THE STAKEHOLDER MEETING DESCRIBE
DRUGS BUT GOTTEN APPROVED FOR
ULTRA RARE CANCERS AND THEN WERE
DROPPED BY INDUSTRY BECAUSE
THERE WASN'T A MARKET. THAT IS
PARTS OF THIS IS FIGURE OUT THE
GOVERNMENT STAKE THAT STUFF BACK
AND MAKE SURE IT STAYS AVAILABLE
FOR THE PATIENTS.
>>WE HAD TO DO A LOT, KATHLEEN,
TO GET YOU -- PEDIATRICS ON THE
AGENDA, INDUSTRY AT ALL ALL. ANW
THIS NEXT PHASE, IT IS
INTERESTING O TO SEE HOW THIS
GOES. I COME BACK WITH A COMMENT
ON IP, IF YOU PROTECT IT
CAREFULLY THAT INDUSTRY WILL
CERTAINLY ENTERTAIN THE IDEA.
BUT MAYBE CERTAIN COMPANIES THAT
BECOME SPECIALISTS IN THIS AREA.
AND FOR RARE TUMORS I CAN SEE
THAT IN THE FUTURE.
>>I TALKED TO SOMEONE FROM AN
ASTRA ZENECA SPIN OFF INTERESTED
IN THIS KIND OF THING. TALKING
TO PEOPLE ABOUT THE NUTS AND
BOLTS OF LICENSING. I THINK THAT
THERE IS A LOT OF FEAR THAT
BRINGING SOMETHING -- BRINGING
SOMETHING FORWARD THAT IS
ALREADY GOOD IN A COMMON
APPLICATION, THERE CAN ONLY BE
NEGATIVE REPERCUSSIONS OF
TESTING IT IN SOMETHING ELSE.
THAT IS WHAT WE HAVE TO COME UP
WITH SOLUTIONS FOR.
>>AGAIN, A LOT OF THE WORK IS
DONE. , TARGETS THAT ARE COMMON
IN ADULT CANCERS. AND THE
PROCESSES ARE JUST A BIT
DIFFERENT. THERE'S OVERLAP OF
COURSE. BUT WE HAVE TO CONSIDER
NEW APPROACHES. ANTIBODY BASED
APPROACHES AND MAYBE CELL BASED
THERAPY APPROACHES GO BEYOND THE
STANDARD SMALL MOLECULE DRUG
DEVELOPMENT THAT WE TEND TO
ALWAYS WANT TO FALL BACK TO.
>>THERE'S BEEN A LOT OF
ENTHUSIASM WITHIN OUR DISCUSSION
GROUPS FOR ANTISENSE AND PROTAX
AND THINGS LIKE THIS. AND FOR
THE FUSION PROTEINS AND
PEDIATRICS THOSE AREN'T GOING TO
BE APPLICABLE. BUT THEY MAY BE
INCREDIBLY EFFECTI EFFECTIVE. IU
THINK IN TERMS OF PRODUCTIVE
YEARS OF INDIVIDUALS, THAT YOU
ARE TREATING, I THINK FROM A
SOCIETAL POINT OF VIEW IT IS A
GREAT INVESTMENT.
>>INCREDIBLE ADVANCES IN CRYOEM
WILL HELP WITH STRUCTURAL
BIOLOGY AND REALLY
UNDERSTANDING, IF SOME OF THESE
ARE DRUGGABLE TARGETS.
WONDERFUL WORK. I AGREE WITH
MONICA, THIS IS WHEN WE THINK
ABOUT THE INTRAMURAL PROGRAM, WE
CAN BE DONE THERE, THAT CAN'T BE
DONE ANYWHERE ELSE THAT'S THE
WORK THIS IS, THANK YOU SO MUCH
FOR ALL THESE EFFORTS.
>>I THINK WE NOW WILL CONSIDER
ONGOING BUSINESS. SO PRIOR TO
ADJOURNING THE OPEN SESSION ARE
THERE OTHER ISSUES THAT ANY OF
THE MEMBERS OR NCI PARTNERS
WOULD LIKE TO CONSIDER
ADDRESSING? I THINK WITH ALL THE
BUDGET, IT WAS GREAT TO ENDS ON
THAT TALK. RIGHT? ALL OF THE
SORT OF THE BUDGETARY CONCERNS
AND DISCUSSIONS. I THINK MANY OF
US DEFINITELY WANT TO PROTECT
OUR TRAINEES AT OUR EARLY STAGE
INVESTIGATORS. I THINK CERTAINLY
BACK TO THAT IN FUTURE MEETINGS
WOULD BE AWESOME. I THINK AS
MENTIONED EARLIER WOULD BE GREAT
TO HEAR MORE ABOUT THE PAST, THE
PRESENT, THE FUTURE FOR THE
CANCER MOON SHOT. HOW WE SHORE
THAT UP AND MAKE SURE THAT ALL
OF THE INVESTMENT THAT WAS PUT
INTO IT CONTINUES TO BE
LEVERAGED. ANY ADDITIONAL
QUESTIONS AND COMMENTS FROM THE
BOARD? OKAY. PAULETTE.
>>SUGGESTIONS FOR FUTURE AGENDA
ATEAMITEM?
>>I MENTIONED THE TWO, WOULD
LOVE TO HEAR FROM OTHERS.
>>HOWARD, DID I SEE YOUR HAND?
>>YES. BIOMARKERS. THE
BIOMARKER CONSORTIUM NCI
SUPPORTS IN COLLABORATION WITH
INDUSTRY AND CMAX, WE HAVE HAD
REVIEWS OF THIS IN PAST YEARS
BUT THERE IS A LOT OF WORK AND
FAILURES IN MY VIEW.
INTERVENTIONS DRIVEN BY SOME OF
THOSE BIOMARKERS. AND I THINK IT
WOULD BE GREAT TO HEAR WHERE
SOME OF THOUGHT LEADERS ON THAT
SEE THE BARRIERS AND HOW WE ARE
GOING TO ADDRESS THAT GOING
FORWARDFORWARD. IN TERMS OF IMG
THE PUBLIC HEALTH USING
IMMUNO-ONCOLOGY PRODUCTS WHICH
WERE REALLY SOME OF THE GOALS
WHEN I SAY BIOMARKERS I MEAN
ESPECIALLY COMPANION DIAGNOSTICS
TO BETTER DESIGN NEW TRIALS,
SUCCESSFUL NEW TRIALS.
>>YOU SAID BIOMARKERS C MAX.
OKAY.
>>CMAC INSTITUTIONS THAT ARE
PART OF THE MOON SHOT THAT WERE
FUNDED BY THE MOON SHOT
CONSORTIUM TO VALIDATE
IMMUNO-ONCOLOGY BIOMARKERS.
>>ARE THERE OTHER SUGGESTIONS
FOR FUTURE AGENDA ITEMS?
>>I WOULD LOVE TO HEAR MORE
ABOUT FUTURE OF NCOR IN TERMS OF
THE STRATEGY GOING FORWARD,
INTEGRATION CANCER CENTERS AND
BE GET TO HEAR A LITTLE BIT
MORE, NOT ABOUT THE PREVIOUS BUT
WHAT IS MCOR THINKING ABOUT IN
TERMS OF THE FUTURE. SUCH AN
IMPORTANT COMPONENT OF THE NCI.
>>OKAY.
>>KAREN.
>>THANK YOU SO MUCH. THANK YOU
FOR ALL THE PRESENTATIONS. I
WOULD LIKE TO HEAR MORE ABOUT
THE MULTI-CANCER DETECTION. I
THINK THAT THAT IS AN AREA THAT
WE NEED TO BE ON THE FOREFRONT
ON. IT IS AN EXPENSIVE PROPOSAL
IN MANY, MANY WAYS AND WE ARE
JUST TALK ABOUT BUDGET CUTS,
VERY NICE TO HEAR MORE ABOUT
WHAT THE NCI IS DOING AROUND
THIS AREA, SPECIFICALLY, I KNOW
THERE ARE LARGE CONSORTIA, THERE
ARE WORK FROM NCDs BUT HELPFUL
TO UNDERSTAND THE RESEARCH
LANDSCAPE IN THIS SPACE. OTHER?
OKAY. WE HAVE THREE FUTURE
AGENDA ITEMS PROPOSED.
>>I HAVE THE TWO OTHERS LISTED
FOR YOU, PAULETTE TOO. THERE'S
TWO MORE THAT DR. CARPTEN
PRESENTED, I CAN GET THEM TO YOU
AFTERWARD.
>>OKAY. THANK YOU.
>>GREAT. WITH THAT, WE WILL
ADJOURN THE OPEN SESSION. SO
THERE WILL BE ROUGHLY 15 MINUTE
BREAK OR ACTUALLY A BIT MORE
THAN 15 MINUTES. WE WILL -- WE
NEED EVERYONE TO COME BACK TO
START THE CLOSED SESSION AT 4:15
EASTERN. OKAY?
>>HAVE THEM RETURN AT 4:10 AND
THAT WAY WE WILL HAVE THEM ALL
IN ACCOUNTED FOR.
>>E WHERE. YES.
>>10 AFTER. EVERYONE TAKE A
SHORT BREAK. AND I THINK YOU
WILL LOG OFF TO THIS AND WILL IS
A SEPARATE LINK IN THE EMAIL
THAT WAS PROVIDED FR. 4:10 EASTN
TIME WE WILL RECONVENE.
>>THANK YOU.