OKAY, I WOULD LIKE TO WELCOME
THE NCI BOARD, NCAB STAFF AND
GUESTS AND LIKE TO EXTEND A WARM
WELCOME TO DR. CAMERON RASMILL
WHO HAS SUCCESSFULLY
TRANSITIONED FROM BEING A BSA
MEMBER TO NCI DIRECTOR AS WE ALL
KNOW AND I THINK THIS IS HER
FIRST BOARD MEETING AS NETWORK
CI DIRECTOR AND IT'S FIRST
IN-PERSON, FIRST IN-PURPOSE
YOINT MEETING.
OKAY, IT'S GREAT TO HAVE YOU AT
THE HELM CHEM AND I LOOK FORWARD
TO WORKING WITH YOU.
SHALL WE?
>> FOR THOSE WHO DON'T KNOW
PAULET, WE ARE SCRIPTED HERE.
BUT I WILL GO OFF SCRIPT AND
SAY,--UH OH.
IT'S OPERATE TO BE HERE IN
PERSON, AND SEE EVERYBODY IN
PERSON, BUT I WON'T SAY ANYTHING
I SHOULDN'T SAY BUT I HAVE 1
PRIVATE SECTOR LEMMING OF
WATCHING RARK SMILL CALLING
PASHTS AT 10:00 O'CLOCK AT NIGHT
AFTER FINISHING PATIENTS IN THE
LAB.
WHAT I CAN TELL YOU IN AITITION
TO HER MANY ADMINISTRATIVE
STANDARDS AND HER COURAGE IN
TAKING ON THIS JOB AT THIS TIME,
IT'S A WONDERFUL COMPASSION AND
JUST WANT TO SAY THANK YOU. .
[ APPLAUSE ]
>> THANKS, SO JUST REQUIRED
ANNOUNCEMENTS, MEMBERS OF THE
PUBLIC WHEN MAY WISH TO EXPRESS
THEIR VIEWS REGARDING ANY IERK
TEMS DISCUSSED DURING THIS
MEETING, MAY DO SO BY WRITING TO
DR. PAULET GRAY EXECUTIVE
SECRETARY OF THE BOARDS WITHIN
10 DAYS FOLLOWING THE MEETING,
ANY WRITTEN AT THE SAME TIMES OR
QUESTIONS SUBMITTED BY MEMBERS
OF THE PUBLIC WILL RECEIVE
CAREFUL CONSIDERATION.
AS BOARD MEMBERS, I WOULD LIKE
TO REMIND YOU THAT YOU MUST
ABSENT YOURSELF DURING SPECIFIC
DISCUSSIONS WHENEVER YOU'RE
PARTICIPATION DELIBERATIONS ON A
PARTICULAR PRODUCT PROGRAM OR
OTHER SPECIFIC MATTER WOULD
CONSITUTE A CONFLICT OF INTEREST
OR CREATE THE APPEARANCE OR
PERCEPTION OF 1.
IT IS INCUMBET UPON OURSELVES TO
ADVICE THE EXECUTIVE SECRETARY
AND ABNORMALITIES STEAN FROM ANY
PARTICIPATION AND DISCUSSION OR
ACTION REGARDING THAT MATTER.
CONSIDERING THE CURRENT POLICIES
GOVERNING CONFLICT OF INTEREST,
BASED ON FINANCIAL HOLDINGS OF
SPECIAL GOVERNMENT EMPLOYEES
WHICH WE ALL ARE AS BOARD
MEMBERS, WE MUST DEPEND UPON
OURSELVES TO VOLUNTARILY ABSENT
OURSELVES DURING ANY AND ALL
DISCUSSIONS OF MATTERS THAT
COULD CONCEIVABLY IMPACT THE
STATUS OF ANY OF THESE HOLDINGS.
SO WOE HAVE TO TRUST OURSELVES
AND OUR JUDGMENT IN THESE
INSTANCES.
DURING IN CLOSED SESSION, ANY
MATERIALS OR DISCUSSIONS OF A
CONFIDENTIAL NATURE DLBED UPON
TODAY ARE PRIVATE SECTOR LENLED
INFORMATION AND ARE MADE
AVAILABLE ON A NEED TO KNOW
BASIS AND THEY ARE PRIVATE AND
THEIR CONTENT SHOULD NOT BE
DIVULGED.
SO FUTURE MEETINGS ARE LISTED ON
THE AGENDA AND ARE ON THE CANCER
.GOV WEBSITE.
BY LAW A QUORUM IS REQUIRED FOR
EACH INSTANCE WHETHER A VOTE MAY
OCCUR, DURING OPEN OR CLOSING,
DURING THIS MEETING 23 MEMBERS
MUST BE PRESENT TO VOICE THEIR
VOTES.
SINCE WE CAN'T PREDICT THE TIME
OR OCCURRENCE OF ANY MOTION, OUR
PRESENCE IN THE ROOM INCLUDING
THE VIRTUAL ROOM FOR ALL
SEGMENTS OF THE MEETING IS
CRITICAL.
IT SHOULD BE NOTED THAT WHEN WE
DO--DO THE CONCEPTS LATER TODAY,
WHILE BOTH BOARDS CAN
PARTICIPATE IN THE DISCUSSION,
ONLY BSA NUMBERS WILL BE COUNTED
IN THE VOTE, THUS THE QUORUM AT
THAT TIME WILL BE 13 MEMBERS,
ADDITIONALLY FOLLOWING THE
SUBCOMMITTEE REPORTS ONLY NCAB
MEMBERS WILL BE COUNTED IN THE
VOTE, ALL BOARD MEMBERS CAN
PARTICIPATE IN THE DISCUSSION.
THE QUORUM AT THAT TIME WILL BE
10, PAULET DO WE HAVE A QUORUM.
SO FUTURE MEETING DATES ARE IN
THE BOOKS AND ARE ON THE AGENDA.
THE NCAB AND NBSA MUST CONFIRM
THE 2026 MEETING DATES SO THE
MEMBERS CAN AND SHOULD VOTE, SO
I WOULD LIKE TO CALL A MOTION TO
CONFIRM THE 2026 MEETING DATES.
DISCUSSION.
SO LET'S VOTE?
ARE THERE ANY NAYS?
ANY ABSTENTIONS IT'SUNE NANOG
MOUSE, WE ALSO HAVE TO APPROVE
THE FEBRUARY 2024 NCAB VIRTUAL
MINUTES AND ONLY NCAB MEMBERS
SHOULD VOTE.
I WOULD LIKE TO CALL A MOTION TO
APPROVE THE MINUTES.
DISCUSSION PROMPTLY MOVE THE
SECURITIZATION.
LET'S VOTE.
ANY NAYS IN ABSTENTIONS?
IT'S UNANIMOUS.
WE ALSO MUST--SHELLY THIS IS
YOU.
>> USE THE ME C.
>> WE ALSO MUST APPROVE THE
VIRTUAL MARKETPLACE 20 BSA
MEETING AND BSA MEMBERS TO VOTE.
MAY I HAVE A MOTION TO APPROVE?
>> SECOND.
>> ARE THERE ANY NAYS?
ANY ABSTENTIONS?
OKAY,.
>> THANKS, SHELLY, ALL SMART
PHONES AND SIMILAR DEVICES
SHOULD BE TURNED OFF OR SET ON
VIBRATE.
WHENEVER THESE INSTRUMENTS GO
OFF, THEY CAN DISTURB THE
MEETING SO THIS APPLIES TO STAFF
AS WELL AS OTHER INDIVIDUALS IN
THE ROOM.
AND ANYONE ON VIRTUAL, PLEASE
TURN YOUR MICs OFF AND WE WILL
POINT TO YOU IF YOU HAVE A
QUESTION TO UNMUTE YOUR MICs.
OKAY, SO, WE WILL NOW
BEGENERATED TODAY'S AGENDA WITH
THE NCI DIRECTOR'S REPORT THAT
WILL BE PROVIDED BY
DR. RATHMELL.
>> THERE WE GO.
HOW ABOUT NOW.
GOOD MORNING.
LET'S DO THAT, GOOD MORNING.
OKAY, ALL RIGHT, IT IS SO GOOD
TO BE HERE.
I'M REALLY DELIGHTED WE'RE IN
PERSON AND I WANT TO THANK YOU
ALL FOR MAKING THE TIME TO COME
OUT IN PERSON AND TO BE A PART
OF THIS AMAZING PROGRAM AND TO
REALLY HELP US BE THE BEST THAT
WE CAN POSSIBLY BE.
OKAY, WE WILL TRY THIS AGAIN,
TRYING TO GO TO THE TOPICS OF
THE DAY, SO I'VE BEEN IN THE
ROLE FOR ABOUT 6 MONTHS, SPEND A
LOT OF TIME LISTENING, LEARNING,
GATHERING DATA AND REALLY
FEELING READY TO TART TO MOVE.
WE WILL TALK ABOUT A BUNCH OF
THINGS TODAY.
THERE'S SO MUCH THAT DPZ ON AT
THE NCI, THE THEMES CAN BE
ENORMOUS AND YOU WILL SEE WE
TRIED TO MAKE A GOOD FOCUS FOR
TODAY'S PRESENTATION TO OVER THE
COURSE OF A YEAR OF SERVICE WILL
CALL OUT AS MANY THINGS AS WE
CAN ACROSS THE NCI.
WE WILL OF COURSE TALK ABOUT THE
BUNLET, IT HAS BEEN A CHALERGING
BUDGET SEASON AND PROMISES TO BE
MORE THAT'S I THINK SOMETHING
THIS' REALLY IMPORTANT TO TALK
ABOUT WITH THE BOARD AND WE'LL
ALSO TALK ABOUT MORE HIGHLIGHTS
OF THE OVERALL NCI AND I REALLY
WANT TO EMPHASIZE THE QUESTION
AND ANSWER, I WANT TO HEAR FROM
YOU, HEAR, NOW AND AT OTHER
OPPORTUNITIES AS WELL.
SO STARTING UP WITH JUST A ROUND
UP OF SOME OF THE NEWS THAT
FOCUSES ON OUR PEOPLE, WE CAN
TALK ABOUT OUR PEOPLE IN LOTS OF
DIFFERENT CONTEXTS, BUT I'M
ACTUALLY TARTING WITH SOME OF
YOU, SO THESE ARE THE NEW NCAB
MEMBERS WHO WILL BE YOINING US
THAT HAVE BEEN PUT FORWARD BY
THE WHITE HOUSE, I'M REALLY
EXCITED TO HAVE THEM JOIN.
YOU WILL GET TO KNOW THEM IN A
FUTURE MEETING BUT YOU CAN SEE
THAT WE HAVE CONTINUED
COMMITMENT TO DIVERSITY,
COMMITMENT TO SURGEON SCIENCE,
COMMITMENT TO COMMUNITY,
COMMITMENT TO COMMUNICATION.
SO REALLY EXCITED TO SEE THESE
FOLKS COMING ON SOON.
WE'LL HAVE NEW MEMBERS TO THE
NCAB, ALSO EVENTUALLY TO OUR
OTHER BOARD AND AMERICANS.
WHEN I WAS A BSA MEMBER, I DID
NOT KNOW WE HAD 6 BOARDS BUT WE
HAVE 6 ADVISORY OR COMMITTEE
BOARDS TO THE NCI.
WE DID A LOT OF DIFFERENT WORK
AND SO 1 OF THE THINGS THAT
WE'RE GOING TO BE IMPLEMENTING
IN THE NEXT YEAR IS A WHOLISTIC
ORIENTATION TO THE NCI FOR NEW
MEMBERS OF THE BOARDS.
WE HAVE A COMMITTEE THAT'S
PUTTING THIS TOGETHER, I KNOW
YOU ALL GET ORIENTATION TO THE
WORK THAT YOU DO AND THE
EXPECTATIONS OF BOARD MEMBERS,
BUT I THINK TO BE AN EFFECTIVE
BOARD MEMBER IT'S GOD HAVE A
REAL INSIGHT INTO THE THINGS
THAT WE DO HERE AND SO, I MAY BE
PINNING SOME OF YOU FOR IDEAS OR
OTHER PEOPLE ON THE COMMITTEE
MAYBE DOING THAT AS WE PUT
TOGETHER A PLAN FOR A DAY THAT
REALLY EMERCS PEOPLE TOGETHER,
SO WITH NEW BOARD MEMBERS
GETTING TO MEET THE BOARD
MEMBERS FROM THE OTHER BOARDS AS
WELL, SO MORE DETAILS TO COME ON
THAT.
NOW OTHER PEOPLE NEWS, SO THIS
IS ON THE INTRAMURAL PROGRAM, WE
HAVE A FOCUSED ON NOMINAL SET OF
INVESTIGATORS AND INTRAMURAL
PROGRAM, I WANT TO HIGHLIGHT A
FEW WITH NATIONAL ACCOMPLISH
AMS, WE HAVE 3 NEW MEMBERS, WE
HAVE STEVEN GORGE YORE, SANDRA
WALLEN, AND WE HAVE NEW MEMBERS
TO THE AMERICAN ASSOCIATION OF
PHYSICIANS, WE CAN GO ON AND ON
IT'S A FANTASTIC GROUP OF PEOPLE
BUT I WANT TO HIGHLIGHT THESE
FOLKS IN PARTICULAR WHO REALLY
REPRESENT OUR GROUP VERY WELL.
WELL WE ALSO PLAY A BIG ROLE
ACROSS OUR COMMUNITY AND HERE
JUST EXEMPLIFIES 2 OF THE MAJOR
PROFESSIONAL ORGANIZATIONS IN
THE CANCER WORLD, AACR AND ASCO,
A COUPLE THINGS TO COMMENT ABOUT
THE NCI AND THE PARTNERSHIP WITH
THESE AND OTHER ORGANIZATIONS.
FIRST OF ALL IT WAS REALLY
INSPIRING TO GO TO THESE
DIFFERENT MEETING WITH THE
DIFFERENT HAT AND SEE HOW MUCH
NCI PRESENCE AND COLLABORATION
THERE IS IN THESE COMMUNITIES.
WE HAD 1 IN ACR AND ASCO, REAL
ACHIEVEMENT RECOGNITIONS THAT
COME FROM THE INTRAMURAL
PROGRAM, AGAIN STEVE ROSENBERG
RECEIVING THE LIFETIME
ACHIEVEMENT AWARD AT NCR, AND
SATISH GOP A L, ARE YOU HERE
TODAY, MY MESSAGE AT AACR WAS
FOCUSED ON RECOGNIZING THE FACT
THAT WE'RE MOVING INTEREST A NEW
ERA, AN ERA THAT'S DEFINED BY
MORE COLLABORATION, MORE GROUND
UP RECOGNITION OF CROWD SOURCED
IDEAS.
ACKNOWLEDGMENT OF WHAT WE CAN
LEARN FROM COMMUNITIES AND
UTILIZING DIFFERENT KINDINGS OF
RESOURCES THAT BRING PEOPLE
TOGETHER, PARTICULARLY BIG DATA
AND AI.
AT ASCO, I TALKED ABOUT PUTTING
SOME OF THOSE CONCEPTS INTO PLAY
AS WE RYE TO MOVE CLINICAL
TRIALS FURTHER, FASTER, REACHING
COMMUNITIES THAT THEY NEED TO
SERVE, BOTH RESONATED I THINK
VERY WELL AND HAVE BEEN VERY
HELPFUL FOR THINKING ABOUT NEW
AGENDAS THAT WILL BE ADVANCING
FORWARD.
I WANT TO JUST TAKE 1 MINUTE AND
LET YOU KNOW ABOUT SEVERAL
TRANSITIONS THAT ARE HAPPENING
IN OUR LEADERSHIP.
SOME OF THESE ARE PEOPLE YOU MAY
NOT KNOW BUT WHO MAKE THIS
ORGANIZATION RUN AND SO WHAT
THEY HAVE DONE HAS IMPACTED
EVERYTHING IN THE CANCER SPACE.
THESE 3 ARE RETIREMENTS, THEY'RE
HAPPENING OR HAVE HAPPENED IN
OUR OFFICES, DONNA SEGULL OUR
EXECUTIVE OFFICER, TONY
KD--SALLY WA, THE LEADER FOR THE
CENTER FOR BIO-INFORMATICS AND
INFORMATION TECHNOLOGY AND HENRY
CIOLINO HERE UNTIL THE END OF
THE MONTH WITH THE OFFICE OF
CANCER CENTERS, HENRY ARE YOU
HERE TODAY, HE MAY BE IN AND OUT
A BIT LATER.
THESE FOLKS HAVE COLLECTIVELY
OVER A HUNDRED YEARS OF NCI
EXPERIENCE AND SO THIS IS
REPRESENTING A PRETTY MAJOR
TRANSITION.
AND AN OPPORTUNITY, WE HAVE A
NUMBER OF FOLKS FILLING THOSE
BIG SHOES, WE HAVE ACTING AND
INTERIM AMBER LOWRY WHO IS HERE
SACTING IN A ROLE OF EXECUTIVE
OFFICER, JILL BARHHOLD SLOAN,
SHE'S PROBABLY REMOTE AND CRIST
CHRISTOPH, WILL BE WITH
THEACKING CANCER CENTERS.
ANOTHER PERSON IN OUR INTRAMURAL
PROGRAM, TOM AS DELLY HAS LED
OUR CENTER FOR CANCER RESEARCH
FOR MANY YEARS AND HAS DECIDED
TO FOCUS ON HIS RESEARCH FOR A
BIT.
AS YOU CAN SEE THAT'S REQUIRED 3
PEOPLE TO COVER THAT TERRITORY,
SO IT COVERS CLINICAL AND BASIC
SCIENCE AND SO WE HAVE A DUAL
FUNCTION ACTING SPACE WITH GLEN
MERLINO, AND TBLEN IS ALSO
RETIRING AT THE END OF JUNE AND
CAROL WILL TAKE IT FORWARD AS WE
CONDUCT A NATIONWIDE SEARCH.
SO IN TERMS OF THINGS COMING
SOON, WE HAVE BEEN DOING A LOT
OF RECRUITING AND SO WE WILL
HOPEFULLY BE ANNOUNCING SOON IN
COMING MONTHS, EXECUTIVE
OFFICER, WE'VE HAD AN ACTING FOR
SOMETIME AT THE FREDERICK LABS
AND THE DIRECTOR OF SCIENCE
OPERATIONS AND OUR NEW CENTER
FOR EXTERNAL AFFAIRS, THE IDEA
IS TO BRNG A DIRECTOR THAT
BRINGS TOGETHER, COMMUNICATIONS,
OUR LEGISLATIVE BRANCH AND OUR
ADVOCACY SO THAT WE'RE ALL
REALLY COORDINATED VERY WELL, SO
LOOK OUT FOR THAT NEWS.
THIS IS MY BIG ANNOUNCEMENT OF
THE DAY.
SO WE DO HAVE A BIG NEW
LEADERSHIP POSITION TO ANNOUNCE
AND THIS IS DR. WARREN
[INDISCERNIBLE] WHO IS OUR
INAUGURAL DIRECTOR FOR DATA
SCIENCE, SO I SHOULD MAKE YOU
STAND UP.
SO HE HAS A LONG STANDING
HISTORY WITH THE NCI HERE AND
HAS BEEN AN ADVISOR FOR SOMETIME
AND VERY NATURAL FIT TO TAKE ON
THIS ROLE, DATA IS SUCH AN
IMPORTANT PART OF EVERYTHING
THAT WE DO, AND HIS ROLE WILL BE
TO DIRECT THAT CENTER FOR
BIOMEDICAL INFORMATICS AND IT AS
OUR--AS A MAJOR TOOL, BUT ALSO
TO BE COORDINATING OUR EFFORTS
WITH THE NIH AND THEIR STRATEGIC
PLAN FOR DATA SCIENCE AND
DEVELOP AND IMPLEMENT OUR PLAN
AROUND DATA SCIENCE, SO JUST A
LITTLE BIT TO DO SO WE'RE SO
FLAD YOU'RE HERE WARREN.
AND THEN ROUNDING OUT THE TEAM,
AS WE'RE GOING TO TALK A LOT
ABOUT TODAY IS INITIATIVES TO
ENHANCE THE CLINICAL TRIALS
SPACE AND SO WE BROUGHT ON AS A
SENIOR ADVISOR FOR CLENICAL
RESEARCH DR. SHALON BEGGASHING,
WHO HAS EBFOCUSED ONIVATIONS IN
CLINICAL TRIAL DESIGN EMPLOY HE
AND I WROTE A BLOG AND THIS WAS
AN ADVERTISEMENT, THE CANCER
CURRENTS BLOG AND UPDATED
REGULARLY WITH HIGHLIGHTS OF
WHAT'S GOING ON ACROSS THE NCI,
I ENCOURAGE PEOPLE TO FOLLOW IT,
IT'S A PHENOMENAL COMMUNICATION
DEVICE AND WE WROTE ABOUT WHAT
WE'RE INITIATING.
I THINK LEADERSHIP TRANSITIONS
ARE NOT JUST ABOUT THE PEOPLE IN
THE CENTRAL OFFICE BUT HOW WE
REALLY ENGAGE LEADERSHIP ACROSS
THE ENTIRETY OF THE NCI, MANY OF
YOU WERE AT OUR ADVANTAGE HOC
COMMITTEE MEETING LAST NIGHT AND
HEARD ABOUT THE CANCER EQUITY
LEADERS, ACTUALLY A BUNCH OF OUR
CANCER EQUITY LEADERS ARE HERE
AT THE TABLE AND THEY ARE A
TREMENDOUS DPROWP OF ROLL MODELS
AND LEADERS ACROSS THE CANCER
COMMUNITY TO ENABLE US TO REALLY
TAKE ON HOW WE BRING DIVERSITY
TO OUR WORKFORCE, DIVERSITY TO
OUR CLIEN CALIFORNIA TRIALS AND
WHAT WE NEED TO ALL PATIENT
COMMUNITIES.
WE ALSO ENDORSE LOTS OF PEASHT
ACTIVITIES TO TRY TO ENCOURAGE
LEADERSHIP IN SPACES THAT ARE
IMPORTANT FOR THE NCI.
ONE EXAMPLE THAT I'M REAL
LOAMACYY PROUD OF AND IT WILL
HAPPEN NEXT WEEK IS THE BLACK IN
CANCER CONFERENCE, THIS WAS
SPEARHEADED BY FELLOWS WHO FELT
THERE WAS A NEED FOR VOICES FOR
BLACK RESEARCHERS.
ONE OF THEM WAS AT VANDERBILT
AND I GOT TO SEE THIS HAPPEN IN
ACTION AS IT WAS FIRST A #AND
THEN MOVED INTO A MOVEMENT AND
NOW IT'S A CONFERENCE WE'RE
HOSTING HERE WHICH I WILL SAY
INITIALLY NOT SOLE OUT, I THINK
TICKET WERE FREE, IT WAS FULL
DPOA HAD A WAITING LIST, HAD TO
EXPAND IT, AND IT'S REALLY GOING
TO BE A DYNAMIC AND EXCITING
THING, SO LOOKING FORWARD TO
YOINING THEM INCOME WEEK AND THE
LIST IS ABOUT DOING THINGS RIGHT
AND SONIA SPRING FIELD, I KNOW I
SAW YOU AND SO, THERE YOU ARE,
YES, SO SHE'S OUR DIRECTOR OF
CRCHD, THE CANCER RESEARCH AND
HEALTH DISPARITIES, NOW I CAN'T
THINK OF THE ACRONYM, THAT'S WHY
WE'RE CHANGING IT, SO SHE
BROUGHT TO ME A CONCEPT THAT HAD
BEEN BREWING FOR A BIT TO REALLY
FOCUS ON HEALTH EQUITY AND TO
FOCUS ON THE POSITIVE, THE
IMPACTS THAT WE CAN HAVE BY
DOING REAL WORK TO AGAIN REACH
POPULATIONS WELL TO DEVELOP
INVESTIGATORS WELL AND SO IF
THERE'S A NAME CHANGE COMING
SOON AND THAT CENTER WILL NOW BE
CALLED THE CENTER FOR CANCER
HEGHT EQUIT COMPETENT AGAIN FOR
THOSE OF YOU AT THE
SUBCOMMITTEES LAST NIGHT, I
REALLY LOVED--SHE SAYS THIS
ACRONYM AND YOU SAY IT AND IT
MAKES YOU SMILE.
IT SIZE CCHE.
NGIVE ME A CHANCE TO MOVE UP AND
TALK ABOUT BUDGET.
SO THIS IS JUST TO LEVEL SET AND
LET YOU ALL SEE WHERE WE ARE
WITH BUDGET AND WHERE WE'VE BEEN
WORKING.
SO IN FISCAL YEAR 2023, SO WE
HAVE THE OPPORTUNITY EVERY YEAR
TO PUT FORWARD A PROPOSED BUDGET
FOR THE WORK THAT WE EXPECT TO
DO AND WHAT WE THINK IT WILL
ACTUALLY COST.
OUR PROFESSIONAL BUDGET WAS 7.7
BILL YEN DOLLARS BUT OUR ACTUAL
BUDGET WAS 7.3.
AS YOU KNOW LAST YEAR THERE WAS
THE DEBT CEILING LIMIT AND
ALTHOUGH OUR WORK GOT MORE
EXPENSIVE, THERE ARE MORE THINGS
WE WANT TO DO IN THE DATA SPACE,
IN THE CLINICAL RESEARCH SPACE
AND ACROSS TRAINING AND
EVERYTHING THAT'S IMPORTANT TO
US BUT NOT LUXURIOUSLY.
THIS IS A REALISTIC ESTIMATE OF
WHAT IT WOULD COST TO DO WAWE
DO, AND OUR ESTIMATE WAS ALMOST
10 BILLION DOLLARS AND AS YOU
KNOW WE GOT 7.22.
IT REFLEKS THE FIRST DECREASE
WE'VE HAD IN MANY YEARS WHICH
WAS BOTH THE ASPIRATION OF THE
CURES ACT FUNDING AND INCREASE
OF OUR BASE.
SO CONGRESS RECOGNIZED WHAT IT
WAS THAT WAS HAPPENING AND SO
THERE WAS AN INCREASE TO ENABLE
US TO BE ABLE TO REALLY PRESERVE
THE WORK THAT WE DO.
BUT THE NET DELTO WAS A
96 MILLION-DOLLAR DECREASE AND
WE HAVE A GRAF THAT SHOULD WILL
SHOW THAT IN A MINUTE.
WE KNOW THE DEBT SEALING
CONTINUES FOR ANOTHER YEAR, WE
WILL FIND OUT LATER THIS YEAR
AND MK WILL GIVE THE LEGISLATIVE
REPORT IN A MINUTE, AND WE WILL
BE ABLE TO GET MORE DOWN IN THE
DETAILS.
THE WORK DIDN'T GET LESS
EXPENSIVE, WE'RE NOT DOING LESS
OF IT, SO OUR PROFESSIONAL
BUDGET FOR FISCAL YEAR 25 IS
OVER 11 BILLION DOLLARS.
AS YOU CAN SEE OUR GLAP IS JUST
GETTING BIGGER AND SO WE ARE
SPENDING A LOT OF TIME THINKING
ABOUT EFFICIENCIES, REALLY THINK
BEING WHAT WE CAN DO WITH THE
FUNDING THAT WEB CONNECTED HAVE
BECAUSE WE HAVE A BIG MISSION
AND WE HAVE REAL WORK TO DO TO
END CANCER AS WE KNOW IT.
I WILL SAY TAKEN--THEY THE
WHITE HOUSE IS AWARE THAT YOU
CAN SEE THE PRESIDENT'S GUJET
PROPOSAL FOR FOOTWORK Y25 WAS
FOR 9.28.
WE'RE FOCUS ON THE QUITE MATCHED
BUT ASKED FOR A SIGNIFICANT
INCREASE FOR US AND WE WILL SEE
WHERE WE LAND.
SO WHAT WE DID WITH OUR FY24
BUDGET, I THINK IT'S IMPORTANT
THAT YOU ALL KNOW WHERE THESE
PAY LINES LAST AND HOW THEY TBET
THERE, BECAUSE WE WERE IN A
CONTINUING RESOLUTION FOR A LONG
TIME AND DID NOT KNOW WHAT THE
BUDGET WOULD COME OUT LOOKING
LIKE, WE HAVE TO SET AN INTERIM
PAY LINE BECAUSE WE HAVE TO PAY
SOMEBODY, WE CAN'T WAIT AND HOLD
ALL THE GRANTS UNTIL WE GET A
CONTINUING RESOLUTION, RIGHT,
CRYSTAL, THAT WOULD BE SO
TERRIBLE.
SO WE COME UP WITH AN ESTIMATE
OF WHAT WE THINK WE CAN DO AND
THE ESTIMATE WAS AT 9% FOR RO-1S
WITH A 5% HANDICAP FOR EARLY
STAGE INVESTIGATORS BRINGING
THEM AT 14% AND WE WERE FUNDING
AT 9% FOR R21S.
ONCE WE HADEUR BUDGET WE DID A
LOT OF MATH AND WE WERE ABLE TO
SET THE FINAL PAY LINE AT 10 BUT
RECOGNIZE THAT WE JUST REALLY
HAVE TO SUPPORT OUR EARLY STAGE
INVESTIGATORS AND SO THEY WERE
KEPT AT 17%.
WE ALSO--THEY WERE 17% BECAUSE
LAST YEAR WAS 12 WITH THE DELTA
5 AGAIN, GETTING THEM TO 17, SO
WE DECIDED TO KEEP THEM AT 17%.
WE ALSO WITH A LITTLE BIT OF
WIGGLE ROOM, WE WERE ABLE TO
KEEP CANCER CENTERS WHOLE AND
DIDN'T FURTHER REDUCE THEM
BECAUSE WE FEEL LIKE THAT'S AN
INFRASTRUCTURE THAT SUPPORTS
EARLY STAGE INVESTIGATORS THAT
SUPPORTS OUR CLINICAL RESEARCH
ENTERPRISE AND IS PART OF OW WE
GET INITIATIVES MOVED OUT AND
THE TRAINING BRAVEN WHOLE
OTHERWISE WE WOULD HAVE CUT Ks
AND Ts AND Fs AND THOSE ARE
OUR FUTURE, SO THOSE WERE HELD
FLAT.
SO IN TERMS OF THE PAY LINE
OVERYEARS, THIS GRAPH SHOWS
WHERE THE ESTABLISHED
INVESTIGATOR AND NEW
INVESTIGATORS HAVE BEEN OVERTHE
LAST 10 YEARS, THIS ACTUALLY
MADE ME FEEL SLIGHTLY BETTER
ABOUT THE 10, I WOULD HAVE LOVED
TO MADE THAT NUMBER HIGHER BUT
AS YOU CAN SEE OUR 10 YEAR
AVERAGE IS 10, AND SO FIRST
MESSAGE TO PEOPLE IS THAT 10 IS
PRETTY DARN TIGHT AND WE DO NOT
KNOW WHAT THE BEST 10% GRANT IS.
WE PROBABLY DO SOMETHING GOOD IN
A NUMBER TWICE OR 3 TIMES THAT
BUT THIS IS WHERE IT IS AND THIS
IS WHERE IT HAS BEEN.
BUT THAT'S REALLY NOT FAIR FOR
SOMEBODY JUST STARTING THEIR LAB
WITH THEIR BRAND NEW TECHNICIAN,
WHO THEY'RE ALSO THE BEST POST
DOC IN THE LAB AND WITH THEIR
BRILLIANT NEW IDEA ANDS SO
THAT'S WHY THE EARLY STAGE
INVESTIGATOR, AS YOU CAN SEE
IT'S BEEN AN INITIATIVE NOW FOR
COMING UP ON 10 YORES TO REALLY
SUPPORT THEM MORE, AND SO,
KEEPING THEM AT 17 WAS SOMETHING
THAT WE FELT REALLY STRONGLY
ABOUT.
SO WITH A TIGHT BUDGET, WHAT DO
WE THINK ABOUT, WAARE WE GOING
TO DO, I FIND AUTOHELPFUL TO
THINK ABOUT GOALS AND VALUES
WHEN I HAVE TO MAKE DECISIONS
WITH THE TEAM, FORTUNATELY WOO
HAVE THE NATIONAL CANCER PLAN
WHICH SETS OUT GOALS, THE
NATIONAL CANCER PLAN WAS
PRESENTED OVER AIER AGO AND JUST
OVER AIER OLD AND PUTS TOGETHER
A ROADMAP FOR WHAT WE NEED TO BE
FOCUSING ON TO MAKE BIG
ADVANCEMENTS FOR CANCER.
THIS NATIONAL CANCER PLAN HAS 4
HEALTH CENTERED GOALS THAT
REALLY ENCOMPASSES PATIENT
EXPERIENCE, PREVENTION, EARLY
DETECTION, DEVELOPMENT OF
EFFECTIVE THERAPEUTICS AND
OPTIMAL PATIENT CARE, THAT WHOLE
EXPERIENCE OF THE PASHT WITH
CANCER BUT THEN EMPOWERS THEM
WITH GOALS THAT ARE MACK
MYSELFING DATA UTILITY AGAINST
THESE DATA AI, THEY COME UP ALL
THE TIME.
ELIMINATING INIQUITIES, WE CAN
DO MORE IF WORE REACHING THE
PATIENT WHO IS REALLY NEED OUR
WORK EMPLOY OPTIMIZING THE
WORKFORCE, THIS GETS BACK TO
SUPPORTING EARLY CAREER
INVESTIGATORS, MAKING SURE WE
HAVE A PIPELINE, INSURING PEOPLE
FIND THIS FIELD EXCITING, IT IS
THE MOST EXCITING FIELD THAT
THERE IS.
AND ENGAGING EVERY PERSON AND
THIS IS WHERE WE CAN MAKE SOME
OF THE THAT IGFEST IMPROVEMENT
IN THOSE HEALTH CENTERED GOALS,
REALLY ENGAGING EVERY 1, AND
GABBING TO THE 60S, BACK TO THE
SECTIONAL ANALYSISS TYPE ERA OF
HOW WE ALL NAVIGATE THE WORLD IS
REALLY BRINGING EVERYBODY INTO
PLAY AND THAT LETS US GET TO OUR
MOON SHOT GOALS, IMPROVED HEALTH
OUTCOMES FOR EVERYONE AND
PRODUCING CANCER MORTALITY BY
50%, BY 2047.
THE VALUES THAT WE USE TO APPLY
TO THESE TALENT DEVELOPMENT,
AGAIN, REALLY FOCUSING ON HOW WE
DO THE BEST WORK, WHO DOES THE
BEST WORK, HOW WE GET YOUNG
PEOPLE IN BUT HOW DO WE DEVELOP
PEOPLE AT MIDCAREER AND HOW WE
DEVELOP PEOPLE TO WORK IN THIS
ERA WHERE DATA CONSCIENCE IS
RIGHT OUT THERE AT THE FOREFRONT
AND THAT'S A BIG FOCUS.
CREATIVITY AND INNOVATION,
THAT'S WHAT DREW US ALL INTO
CANCER, I'M SURE AND THAT IS AN
OPPORTUNITY FOR US TO REALLY
PUSH THE NEEDLE AND HELP TO
ENABLE MORE CREATIVITY AND
INNOVATION IN EVERY SPACE THAT
WE WORK IN, ESPECIALLY WHEN
TIMES ARE TIGHT AND WE HAVE TO
BE CREATIVE AND INNOVATIVE AND
EMPOWERMENT.
THIS AGAIN GETS GETS BACK TO EG
EVERY PERSON.
MAKING SURE THOSE VOICES ARE
BEING HEARD.
WHEN WE TALKED AT ASCO ABOUT
REINVENTING CLINICAL TRIALS OR
THINKING ABOUT HOW WE COULD GO
FURTHER, FASTER, WE HAD CALLED
TO ACTION, ASKING THE COMMUNITY
WHAT SHOULD WE DO, LIKE WHAT ARE
YOU SEEING THAT WE ARE MISSING
THAT WE CAN DO FASTER.
WE WILL BE COLLECTING THAT DATA
BUT EVEN THE NAP SHOTS THAT I'VE
SEEN ARE BRILLIANT.
I MEAN PEOPLE IN THE COMMUNITIES
KNOW WHAT THEY NEED AND SO
EMPOWERING THEM TO BE ABLE TO
SPEAK UP IS A BIG PART OF HOW WE
THINK ABOUT THIS IN A TIGHT
BUDGET TIME AND THEN FISCAL
RESPONSIBILITY.
I MEAN THIS IS JUST A REALITY OF
WHERE WE ARE AND HOW WE HAVE TO
MAKE GOOD DECISIONS.
SO LET'S GO INTO MORE FUN WHICH
IS RESEARCH AND PROGRAM
HIGHLIGHTS.
SORRY I DIDN'T USE MY SCRIPT FOR
A REALLY LONG TIME, I HAVE TO
CATCH BACK UP.
OKAY, SO WE WILL TALK ABOUT
SEVERAL EXCITING ADVANCES PARTLY
IN THE GENETICS PROGRAM AND ALSO
IN THE CLINICAL RESEARCH ARENA
BUT THERE ARE ADVANCES ACROSS
ALL THE SPACES THAT WE WORK IN,
THIS IS JUST AS OF TRYING TO
CAPTURE REALLY EXCITING THINGS
IN THE BASIC SCIENCE FIELD, IN
THE AI AND DATA SCIENCE WORK IN
TRANSLATIONAL AND IN CLINICAL
RESEARCH, ALL OF WHICH AGAIN
BACK TO NATIONAL CANCER PLAN IS
NECESSARY AND REALLY IMPORTANT
THAT WE'RE ABLE TO MOVE IT
FORWARD.
OKAY, THE THEME TODAY IS GOING
TO FOCUS MORE ON CLENICAL
RESEARCH AND TRANSFORMING
CLENICAL RESEARCH THAN ON OTHER
PARTS.
AS I SAID THERE'S A LOT OF TO
COVER, SO THAT'S GOING TO BE MY
FOCUS FOR THE HIGHLIGHTS TODAY.
THINGS THAT WE'RE DOING NOW, AND
OF COURSE, THERE'S MORE IN OUR
BACK POCKETS AND MORE COMING,
MORE DECENTRALIZED CLINICAL
TRIAL DESIGN AND ENABLING THE
CLINICAL TRIALS TO GET OUT INTO
THE COMMUNITIES WHERE WE NEED
THEM, WE LEARNED SO MANY THINGS
FROM THE PANDEMIC AS AN EASY
EXAMPLE TO THINK ABOUT WHERE WE
CAN MOVE THINGS.
ONE PIECE YOU WILL HEAR A LOT
MORE TODAY ABOUT IS THE VIRTUAL
CLINICAL TRIALS OFFICE, AND
OPPORTUNITY TO REALLY TAKE THE
VIRTUAL EXPERIENCE OF
INTERACTION INTO THE CLINICAL
WORK SPACE AND INTO THE CLINICAL
RESEARCH SPACE AND A LOT TO
LEARN IN THAT EXPERIMENT.
THE CLINICAL TRIALS INNOVATION
UNIT IS A SPACE WHERE WE'RE
BRINGING TOGETHER, THE NCTN, THE
NCI AND THE FDA TO REALLY WORK
CLINICAL TRIALS, AND WORK ON HOW
WE MOVE THEM THROUGH FASTER.
THE FROWP LAST NIGHT HEARD ABOUT
THE PRAGMATIC LUNG TRIAL WHICH
IS A PRAGMATIC TRIAL THAT WAS
ACCELERATED OR BOOSTED BY THE
CTIU AND NOW THE NEXT MOVEMENT
OF THE CTIU IS TO TAKE ON
DIFFERENT PARTS OF HOW WE
ACCELERATE CLINICAL TRIAL ANDS
HOW WE MOVE THINGS SO THAT THE
TIME TO CONCEPT TO GETTING
THINGS IN THE HANDS OF PATIENT
SYSTEM SHORTER BECAUSE WE'RE
LOOKING AT A WORLD THAT MOVES
FASTER AND SO OUR CLINICAL
TRIALS SPACE HAS TO KEEP UP, 1
OF THE THINGS I'VE BEEN MOST
INSPIRED BY IN THESE LAST COUPLE
MONTHS IS INCREDIBLE ENGAGEMENT
OF THE FDA, THEY ARE REALLY
COMMITTED TO MAKING IT A
REALITY, AND WE CAN BE A PART OF
MOVING THAT FORWARD.
I JUST WANT TO GIVE A SHOUT OUT
TO THE MATCH AND SO IT WAS AN
EXAMPLE OF HOW IT COULD ACCRUE
RAPIDLY WITH LOTS OF QUESTIONS
IN A WELL DESIGNED MANNER.
KUDOS TO JIM DOROSHOW, WHO HAS
LED THESE INITIATIVES AND NOW
WITH MILE A MATCH WHICH JUST
OPENED AND COMBO MATCH WHICH IS
ALMOST--I CAN'T REMEMBER WHERE
THAT 1 IS--OH, SOON.
BUT THESE ARE TRIALS THAT WILL
REALLY TRANSFORM THE WAY WE
INTERACT WITH PATIENTS AND
ENGEAJ WITH THE INTERACTIONS
BETWEEN WHERE OUR PATIENT IS AND
THEIR DISEASE PROCESS AND THEIR
THERAPY AND JUST MORE BROADLY
INCORPORATING ACROSS THE
CLINICAL TRIAL BASE.
SOME CLINICAL EFFORTS TO
COLLABORATE AND TRANSFORM IN THE
CLINICAL RESEARCH SPACE, WE ALSO
HEARD LAST NIGHT ABOUT THE
VANGUARD STUDY LOOKING AT
MULTICANCKER DETECTION TESTS TO
WORK IN THE PRIMARY CARE SPACE
AND TO REALLY KNOW HOW TESTS OF
MULTIPLE CANCERS CAN BE USED
EFFECTIVELY, HOW DO WE
COMMUNICATE ABOUT THAT, WHAT IS
THE INFRASTRUCTURE BEHIND IT TO
MANAGE THOSE PATIENTS AND SO
MANY QUESTIONS WE WILL LEARN BY
TAKING ON A QUESTION LIKE THAT.
THE SHIP TRIAL IS ANOTHER TRIA,
SELF-COLLECTION FOR HEART ATTACK
PV TESTING FOR ENGAGING EVERY
PERSON, PUTTING IN THE TESTING
INTO THE HANDS OF PATIENTS TO
KNOW THEIR OWN RISK FOR CERVICAL
CANCER BASED ON THEIR HPV STATUS
AND SO REALLY A LOT OF BOLD
THINKING IS GOING INTO THAT
STUDY AND THEN FINALLY, I JUST
POINT OUT, THAT WE'RE NOT DOING
THIS ALONE, THIS IS--ANSWERS A
GLOBAL PROBLEM AND THE ISSUES
ARE NOT UNIQUE AND WE CAN DO
MORE TOGETHER IN THE
INTERNATIONAL ASSOCIATION FOR
RESEARCH ON CANCER AND THE G7.
BIG FOCUS IS ON PREVENTION, BUT
RARE TUMORS, YOU THINK ABOUT AS
WE LEARN ABOUT MORE AND MORE
COMPLEX SUBDIVISIONS AND ULTRA
RARE TUMOR TYPES, THERE'S NO
CENTER IN THE UNITED STATES THAT
CAN REALLY MANAGE, IN THE WHOLE
UNITED STATES EVEN COVER A
DISEASE THAT MIGHT ONLY HAVE 30
OR 40 DIAGNOSIS IN A YEAR, WE
REALLY HAVE TO TAKE THIS GLOBAL
AND WORK TOGETHER AND SO THOSE
OPPORTUNITIES ARE REALLY WHERE
WE CAN MAKE A BIG DIFFERENCE.
ON THE THEME OF BRINGING CANCER
RESEARCH INTO THE COMMUNITY,
THIS WAS SOMETHING THAT CAME UP
MANY TIMES IN MY EARLY WEEKS IN
THIS JOB AND REALIZING THAT
THERE ARE ASSETS IN THE
COMMUNITY THAT WE ARE PROBABLY
SILOED FROM AND THERE ARE IDEAS
THAT WE NEED TO BE ABLE TO BRING
FORWARD AND THERE'S A LOT TO
REALLY TACKLE TO ACHIEVE A GOAL
WHERE EVERYONE GETS THE CARE
THAT THEY NEED AND EVERYONE HAS
ACCESS TO A CLINICAL TRIAL WHO
WOULD LIKE TO HAVE 1.
AND SO WHAT WE DECIDED TO DO WAS
GET AN ADHOC WORKING GROUP
TOGETHER AND SO I'M REALLY
EXCITED ABOUT THIS GROUP.
SO THIS GROUP JUST LAUNCHED
ABOUT A MONTH AGO, AND IS TAKING
ON THESE QUESTIONS AND WILL BE
BRINGING BACK AND WE'LL HAVE THE
REPORT HERE ON WHAT THEIR
FINDINGS ARE, WHAT IS THE
SHORT-TERM MEDIUM TERM,
LONG-TERM THINGS THAT WE AT THE
NKRRK I AND IN OTHER COMPONENTS
OF THE GOVERNMENT CAN DO TO
REALLY ACHIEVE THAT OUTCOME.
I HAVE TO GIVE KUDOS TO RAY
[INDISCERNIBLE], SO RAY IS A CO
CHAIR, BUT WE HAVE OTHER MEMBERS
OF THE COMMITTEE WHO ARE HERE
INDICATED IN BLUE, BILL AT THE
AMERICAN CANCER SOCIETY, THIS IS
NOT AN NCI, WE WILL SOLVE THE
PROBLEM, WE WILL REACH OUT TO
THE COMMUNITY.
OUR EXECUTIVE SECRETARY IS
ANDREA DENICOFOOTWORK FOOTWORK,
SHE'S NCI BUT SHE'S BEEN A
LEADER IN HOW WE BRING CLAINICAL
TRIALS TO THE VA IN PART MERSHIP
AND WE HAVE PARTNERS HERE ACROSS
THE FEDERAL GOVERNMENT AND IN
OTHER SPACES AS WELL IN PRIVATE
SPACES, TOO.
AND THEN FINALLY I'M VERY
COMMITTED TO HEARING FROM THE
COMMUNITY.
SO I ALREADY MENTIONED WE'VE
DONE A COUPLE OF OPEN CALLS TO
SEE MEN AND WOMEN PEOPLE HAVE TO
SAY, THAT WAS 1 OF THE FIRST
THINGS I DID, GOT REALLY
INTERESTING FEEDBACK, AND MORE
RECENTLY, HOW CAN WE REIMAGINE
CLINICAL RESEARCH TO ACCELERATE
PROGRESS WITH PEOPLE WITH
CANCER.
THIS IS JUST AN EXAMPLE OF 1
RESPONSE TO MANY THAT GIVES US
SOME REALLY GOOD FEEDBACK,
HONEST, SOME OF IT VERY CRITICAL
WHEN DO WE PUBLISH THE THINGS
THAT DIDN'T WORK, HOW DO WE GET
THE WORD OUT THERE SO PEOPLE
DON'T TRY TO REINVENT THE WHEEL,
RESOURCES ARE LIMITED AND
PEASHTS DON'T WANT TO WAIT FOR
THAT AND WEB CONNECTED HAVE TO
BE ABLE TO WORK TOGETHER, I'VE
BEEN WORKING WITH TRAINEE GROUPS
AND ADVOCATES AND WHEN I VISIT
PLACES, I'M ASKING TO MEET WITH
TRAINEES AND I'M ASKING TO SPEND
TIME AT NCORP SITES REALLY
SEEING WHAT THE WORK IS THAT
WE'RE DOING EVERYWHERE, AND IN
TERMS OF WHERE DO WE PUT OUR
PRIORITIES, 1 OF THE THINGS THAT
WE'RE DOING THAT'S NEW THAT I'M
REALLY EXCITED ABOUT IS HAVING A
NEW ANNUAL SCIENTIFIC RETREAT,
SO THIS WILL BE HELD IN JULY, WE
ARE IN THE FINAL DAYS OF GETTING
THIS PLANNED UP, SO OUR
LEADERSHIP WILL BE GETTING
TOGETHER, LOOKING AT WITH GROUPS
THAT HAVE DATA SOURCES TO SAY
WHERE ARE THE BIGGEST GAPS,
WHERE CAN WE HAVE A BIG IMPACT,
WHAT IS IT THAT WE'RE LOOKING TO
DO, I MAKE A POINT THIS IS NOT
JUST AN NCI, WHAT WE THINK ABOUT
YOU WE'RE ASKING FOR COMMUNITY
MEMBERS TO BE ABLE TO I DON'T
KNOW US OR BSA CHAIRS ARE
INVITED TO JOIN IN OUR GROUP
WORKING GROUPS ARE INVITING
OTHERS AS WELL.
SO WE WILL PUBLISH THE OUTPUT OF
THIS AND WE WILL GUIDE, I AM
SURE IT WILL SHOW UP HERE THE
NEXT TIME I TALK ON THIS PODIUM,
AND DEPENDING ON HOW THIS IS
SCHEDULED AND ALSO WHERE WE PUT
OUR EMPHASIS, WHEN WE'RE WRITING
THINGS LIKE RFAs, AND SO I'M
HOPING YOU SEE BSAs AND THEY
SHOULD REVIEW THEM AND FEEL
REFRESHED AND FEEL LIKE THERE'S
SOMETHING WE NEED TO DO TODAY.
SO THAT'S THE GOAL.
SO WHAT I NEED FROM YOU I NEED
TO HEAR AND THAT CAN BE HEAR OR
LATER WHEN THE MOOD STRIKES
WHERE YOU WOULD PRIORITIZE
INNOVATION BECAUSE STAY THE
THEME WAS CLINICAL RESEARCH, IN
THE CLINICAL RESEARCH SPACE OF
COURSE I WILL TAKE ALL.
WITH REGARD TO FUNDING PLANs
BECAUSE WE WILL TALK ABOUT OUR
PHASE TODAY IN PRs, I WANT TO
MAKE SURE YOU KNOW YOUR INPUT
ARE INCREDIBLE LOAMACYY VALUABLE
AND THAT YOUR COMMENTS HELP US
LEVEL SET AND INSURE WE ARE
REALLY AT AING OUT IN FRONT.
I WILL ALSO SAY WE HAVE PUT A
LOT OF WORK INTO OUR INTERNAL
VETTING PROCESS, TO LOOK AT
PRs AND THINK ABOUT WHETHER
THEY ARE READY TO HAVE LIVED
THEIR LIFE, AND SUN SET OR IF
THEY ARE REALLY STILL PUSHING
AND THAT THEY ARE NECESSARY TO
KEEP.
SO THAT'S BEEN A TOPIC OF
PEOPLE, AND SO WITH YOUR
SUGGESTIONS HOW WE MOVE FORWARD.
SO I HAVE TO END WITH THERE IS
SO MUCH TO BE OFTMYSTIC ABOUT, I
GET A LOT OF ABOUT IT'S SO SAD
ABOUT THE BUDGET, AND IT IS A
TOUGH BUDGET REALITY, WE KNOW
NEXT YEAR'S LIKELY TO BE TOUGH
AS SLOW BUT WE CAN'T SLOW DOWN
AND THERE'S SO MUCH GOOD WORK TO
DO SO THIS--THIS IS THE BEST JOB
TO HAVE.
THIS IS THE BEST PLACE TO DO IT
AND I THINK I'M JUST THRILLED
WITH WHAT IS THE OPPORTUNITY FOR
THE FUTURE.
AND THAT'S MY LAST SLIDE.
SO THANK YOU VERY MUCH AND I
WILL TAKE QUESTIONS.
>> FLOOR IS NOW OPEN FOR
QUESTIONS, RECOGNIZING
DR. CORONADO.
>> FIRST OF ALL CONGRATULATIONS
FOR HAVING BEEN HERE FOR 6
MONTHS AND PRESENTING THAT
REPORT.
I FEEL REALLY INSPIRED BY THE
NEW FOCUS ON DATA, DATA
HARMONIZATION, DATA SCIENCE
BECAUSE I THINK THAT WE'VE BEEN,
YOU KNOW IN OUR RESEARCH PROGECS
HAVE BEEN DOING A LOT MORE DATA
SHARING THAN WE HAVE IN THE PAST
AND WE'RE KIND OF IN THE NEW ERA
OF DATA AVAILABILITY AND DATA
SHARING AND I THINK IT'S TIME
THAT WE ALSO START THINKING
ABOUT HOW TO INCORPORATE
TRAINING AROUND USING THAT TO
OPEN OUR TRAINING GRANTS AND IN
OUR EDUCATIONAL PROGRAM FOR
THOSE OF US THAT ARE IN ACADEMEC
CENTERS BECAUSE I FEEL LIKE WE
NEED TO REALLY FOCUS ON TRAINING
THE NEXT GENERATION OF
SCIENTISTS TO BE ABLE TO ACCESS
AND USE ALL OF THE AVAILABLE
DATA THAT WILL BE AT THEIR
DISPOSAL.
>> YEAH, HUNDRED PERCENT AGREE
AND I DO THINK IT'S IMPORTANT
THAT WE ARE WORKING IN THOSE
SPACES BETWEEN, RIGHT, THE DATA
SCIENCE AND OUR TRAINING BRANCH
AND MAKING SURE THAT WE'RE
PREPARING OUR NEXT GENERATION
WELL, AND PREPARING US OLDER
FOLKS TO BE ABLE TO NAVIGATE
THIS AS WELL, TOO.
>> DR. HAYES-DIXON.
>> THANK YOU VERY MUCH FOR THAT
EXCELLENT REPORT, I'M REALLY
PLEASED TO SEE THE INCREASE THAT
WE HAVE FOR FUNDING 1 FOR EARLY
STAGE INVESTIGATORS.
I REMEMBER SEVERAL YEARS AGO IN
THIS COMMITTEE WE DISCUSSED HOW
IMPORTANT THAT WAS SO IT'S FIES
TO SEE THAT COME TO FRUALITY
AFTER WE MADE THOSE
RECOMMENDATIONS.
I'M WONDERING IN THAT GAP
BETWEEN THE NOW AND PROPOSED
BUDGET AND THE ACTUAL BUDGET,
WHO WERE THE LEADERS, WAS IT A
DECREASE IN FUNDING--YOU
MENTIONED THE ITEMS OR PROGRAMS
THAT WERE PROTECTED.
WHAT CAN WE EXPECT AS FAR AS
WERE THERE PROGRAMS ELIMINATED
OR REDUCED FUNDING IN SOME
PROGRAMS.
>> IT WAS SHAVES ACROSS OFF
EXISTING GRANTS, IT WAS BETTER
THAN THE PROYECTED, SO IN THE
INTERIM BUDGET WE WERE CUTTING
6% AND WE RATCHETED THAT BACK TO
5 AND WITH THAT WE'RE ABLE TO
KEEP THINGS GOING.
NAND I WILL SAY, I SAID THIS IN
THE LAST TALK, WHEN WE DID CUTS
IT WAS ACROSS THE BOARD, IT WAS
INTRAMURAL AND EXTRAMURAL
PROGRAM, IT WAS THE ONLY THINGS
THAT GOT PRESERVED WERE CANCER
CENTERS AND TRAINING.
>> WOW, THANK YOU.
>> YEAH.
>> [INDISCERNIBLE], CANCER
INSTITUTE.
>> CAN YOU MOVE YOUR MIC UP
CLOSER NHOW IS THIS?
>> ALL RIGHT, CANCER INSTITUTE,
I WANT TO FOLLOW UP ON YOUR
APPOINTMENT OF DR. KIBBIE AS NEW
DEPUTY DIRECTOR, I THINK THAT IS
SO CRITICAL AND IMPORTANT AND
VERY THRILLED ABOUT IT, I WAS AT
THE CANCER CENTERS INFORMATICS
SOCIETY MEETING, AND SPOKE THERE
AND I THINK WHAT WE NEED TO DO
IN THE SPACE OF DATA SCIENCE AND
AI IS REALLY THINK ABOUT HOW IT
TOUCHES EVERY ASPECT OF OUR
SCIENCE AND SO CLINICAL TRIALS,
EVERYBODY HAS ALREADY THOUGHT
ABOUT DATA SHARING ON POPULATION
LEVELS IS A BIG GOAL BUT ALSO
THIS PROGRAM CALLED
COMPLIMENTARY WHICH I SAW IS
LIKE AIMING TO MODEL EXPERIMENTS
BEFORE WE DO THEM IS REALLY
GOING TO BE THE FUTURE AND WE
CAN TARGET OUR APPROACHES
INVITRO AFTER HAVING OR IN VIVO
AFTER HAVING DONE THE INSILIC O
MODERATION AND A VIRTUOUS CYCLE
WHERE WE INTEGRATE INSILL COWILL
BE SO CRITICAL SO I'M VERY
EXCITED THAT YOU ARE MOVE
NOTHING THAT DIRECTION AND I'M
LOOKING FORWARD TO WORKING WITH
DR. KIERK BBIE ON THIS.
NYEAH, SIMULATIONS, DIGITAL TWIN
TYPE--THERE'S SO MANY WAYS WE
CAN USE DATA.
SO YEAH.
NTROY.
>> TROY [INDISCERNIBLE] WITH UC
DAVIS CANCER CENTER, I WAS GOING
TO SAY SOMETHING ELSE BUT
FOLLOWING ON THOSE COMMENTS, I
WILL ALSO MAKE THE POINT THAT
THERE'S ALSO THE REVERSE
EICATION FOR PEOPLE ENTERING
CANCER RESEARCH FROM THE PURE AI
FIELD, A LOT OF EXCITEMENT, A
LOT OF HYPE GOING ON IN THE PURE
AI FIELD AND I THINK THEY'RE NOT
GOING TO DO THIS WITHOUT US AND
JUST TO MAKE THAT POINT BUT MY
QUESTION WAS ACTUALLY BACK TO
THE ESI INVESTIGATORS, OF
COURSE, NO BRAINER, THE RIGHT
THING TO DO, I WAS JUST
WONDERING, WHAT'S THE BALANCE,
TOTAL FUNDING SAY FOR RO-1S TO
GO TO ESA VERSUS ROLL RO-1, IS
IT A HUGE DECISION TO MAKE OR IS
IT A SMALL FRACTION ANYWAY?
>> IT'S RELATIVELY SMALL.
I SHOULD KNOW THE PERCENTAGE,
IT'S UNDER 10% FROM THE ESI POOL
SO IT'S EASIER TO MOVE NYEAH.
BUT IT'S OOLS ALSO GETTING UP TO
17% IS WHERE YOU ARE STARTING TO
FEEL LIKE THESE ARE GOOD AND I
CAN TELL THESE CENTERS NEED
MORE, I DON'T KNOW WHERE THE
INFLECTION POINT IS, IT'S NOT AT
10 SO 17 WAS AN AMOUNT WE COULD
AFFORD BUT ALSO VERY REALISTIC
THAT THOSE ARE GOOD GRANTS THAT
ARE GETTING FUNDED.
>> OKAY, SO WE HAVE SAMUAL
[INDISCERNIBLE] UNIVERSITY OF
CHICAGO.
ONE THING THAT CONTINUES TO BE
AN ISSUE GOING BACK TO CLINICAL
TRIALS AND THE LACK OF
STANDARDIZED DATA FROM PROTOCOLS
AND I AM FLAD TO SEE
DR. DOROSHOW HERE BECAUSE WE'VE
TALKED ABOUT THIS MANY TIMES BUT
I WOULD LOVE TO SEE NETWORK CI
TAKE A STRONG LEADERSHIP STANCE
HERE BECAUSE OF THE AMOUNT OF
PROTOCOLS WRITTEN AND THINK
ABOUT THE ENTIRE AND EXCLUSION
INFORMATION FOR THE LEADERSHIP
TRIALS SOPHISTICATEDY WE WOULD
LOVE TO SEE NKRRK I TAKE A LONG
LEADERSHIP POSITION THERE.
>> ABSOLUTELY, WE HAD A SUMMIT
FOR 2 DAYS ON MOVING ELEMENTS
THAT WAY, BUT ABSOLUTELY THAT'S
1 WAY THAT DOESN'T COST A LOT OF
MONEY, EVERYTHING COSTS MONEY
BUT WHERE WE CAN GET A LOT OF
BEANG FOR OUR BUCK NLUIS?
>> CONGRATULESS AND FANTASTIC
PRESENTATION, GREAT TO BE HERE
IN PERSON, I THINK YOUR EMPHASIS
ON DECENTRALIZE TRIALS AND
REALLY IMPORTANT.
I THINK TELL ALLOW US TO MOVE
SPEED IN A WAY THAT'S FASTER AND
IT WILL PROVIDE ACCESS TO
POPULATIONS THAT TYPICALLY DON'T
HAVE ACCESS TO CLINICAL TRIALS,
IN A WAY THAT'S VERY UNIQUE.
SOME OF THE BARRIERS TO THIS,
EVEN WE'VE BEEN FINDING
[INDISCERNIBLE] FROM MEMORIAL
SLOAN KETTERRING, IS THAT THE
LICENSING FOR MDs AT THE STATE
LEVEL IS RESPHRICTING OUR
ABILITY TO TALK TO OR EVEN
ENGAGE WITH PEASHTS ACROSS
STRAIGHT LINES AND I THINK THAT
WOULD BE SOMETHING TO EMPHASIZE
FROM THIS LEVEL BECAUSE WE CAN
PROBABLY INFLUENCE THAT IN A
UNIQUE WAY, THE OTHER THINGS ARE
SIMPLELE THINGS LIKE DATA
TRANSFER GREEMS, MATERIAL
TRANSFER GROAMENTS, EVERY CENTER
HAS ITS OWN UNIQUE FORMS AND IF
WE COULD CENTRALIZE THAT, THOSE
2 SIMPLE MANEUVERS WOULD HAVE A
TREMENDOUS IMPACT IN YOUR
VISION.
>> WELL, GREAT.
I'M PLAID YOU SAID THAT, I HAVE
ALSO ADVOCATED FOR THE LICENSURE
FOR A TELEHEALTH, COMING FROM A
KINYITATE IN TENNESSEE, IT MAKES
A BIG DIFFERENCE, THAT IS NOT
SOMETHING WE CAN CHANGE BUT IT
IS SOMETHING WE ALL NEED TO BE
CLEAR ABOUT WHERE THAT HAS
IMPACTS FOR PATIENTS.
NWE'RE GOING TO TAKE 3 MORE
QUESTIONS AND I HAVE THEM IN
ORDER SO I'M GOING TO START WITH
KAREN, AND THEN WE'LL GO TO
ISABELL AND THEN DR. NEWMAN.
>> SO GRIT TALK.
I HAVE 2 IDEAS FOR SUGGESTIONS,
1 WE'RE GETTING A LOT OF DATA
SCIENCE AND AI BUT WE HAVEN'T
REALLY TALKED ABOUT DIGITAL
THERAPEUTIC ANDS THERE'S AN
ENTIRE LANDSCAPE FOR DIGITAL
THERAPEUTICS AS IT RELATES TO
BEHAVIOR WHICH IS INVOLVE INDEED
PRIMARY PREVENTION, CANCER
CONTROLS, SURVERIFIORSHIP
RESEARCH ALL ALONG THE ENTIRE
CONTINUUM, IT'S GROWING OUT
THERE, THE MARKETPLACE KNOWS
ABOUT IT AND SO DO PRIVATE
COMPANIES BUT WE'RE NOT REALLY
WHERE WE NEED TO BE IN TERMS OF
NCI AND WHAT WE'RE DOING TO
SUPPORT RESEARCH ABOUT HOW WELL
THESE THINGS WORK.
THE OTHER THING AS YOU THINK
ABOUT INFRASTRUCTURE AND WHAT
YOU WANT TO SUPPORT ESPECIALLY
AS YOU TAKE YOUR TOURS OF THE
NCORPS, WE LEARNED IN THE LAST 2
YEARS ESPECIALLY SINCE COVID
BECAUSE WE'VE GONE AND VISITED
ALL OF OUR NCORP SITES AT OUR
RESEARCH BASE, THERE'S AN
INCREDIBLE AMOUNT OF REDUNDANCY,
ESPECIAL LYE NOW THERE ARE
EXAMPLES WHERE YOU HAVE NCORPS
THAT ARE FUNDED NCORPS THAT
MAYBE ALSO SIT AT AN NCI
DESIGNATED CANCER CENTER, BURDEN
ON THE CRAs, THEY HAVE TO
REGISTER ALL THEIR PEASHTS IN
OPEN FOR YOUR TREATMENT TRIALS
AS WELL AS YOUR NCORPS TRIALS
AND THEN THEY HAVE TO TURN ARK
ROUND AND DO THE SAME THING
AGAIN IN NCORPS TO MEET ALL
THEIR CANCER CENTER REERMTS AND
FOLLOW ALL THEIR LOCAL METRICS.
IF WE WANT TO DECREASE BURDEN AT
THOSE SITES, WE HAVE TO LOOK AT
THAT KIND OF REDUNDANCY IN THE
SYSTEM AND GET THINGS TALKING TO
EACH OTHER BETTER.
AND THEN I DID HAVE 1 QUESTION,
WITH ALL THE EMPHASIS ON
COMMUNITY, IN TERMS OF THE
BUDGET CUTS, ASK THAT MEAN LIKE
THE NCORPS, ALL THOSE COMMUNITY
BASED NCORPS, AND COMMUNITY
BASED NCORPS ARE GOING TO GET
BUDGET CUTS, THAT'S HARD BECAUSE
THEY'RE ALREADY UNDERFUNDED.
NI AGREE.
AND THAT THERE'S A LOT OF THINGS
WE DON'T FIND APPROPRIATELY.
>> WE HAVE ISA BELL AND
DR. [INDISCERNIBLE].
NI LOVE THE COMMENTS AND THE
IDEA OF COMMUNITY I LIKE TO HEAR
THAT RESONATE BUT TO LISA'S
POINT CLINICAL TRIALS, 1 OF THE
THINGS SITTING ON THE IRB FOR
THE ALL OF US RESEARCH PROGRAM
IS A CONSISTENT NOTE THAT
CONSORTIA THAT THEY'RE HAVING
PROBLEMS ENROLLING LOW LITERACY
AND SPANISH SPEAKING BECAUSE OF
THE LONG CONSENTINGS.
I'VE SEEN THAT CONTINUALLY, A
CONCERN, NOT A COMPLAINT BUT A
CONCERN AND I'M WONDERING IF
WHILE WE'RE GOING TO MAKE ENTRY
INTO CLINICAL TRIALS A TAD
EASIER IT STILL MAY BE 1 OF THE
MAJOR OBSTACLES TO GETTING
PEOPLE UNDERREPRESENTED PEOPLE
INTO THESE TRIALS SOIME
WONDERING HOW NKRRK I CAN LEAD
ON PERHAPS LOOKING FOR BETTER
CONSENTED MODELS FOR DEFINITE
COMMUNITIES.
I KNOW UCLA IS USING VIDEO
APPROACHES AND I'M WONDERING HOW
NCI CAN LOOK AT THIS BECAUSE
THEY REALLY NEED TO CHAIMPLE THE
CONSENT IN IN MANY WAYS,
EVERYBODY SAYS THEY'RE TOO ALONG
ANYWAY, FOR LIT RASE MODEL EXPE
OTHER MONOLINGICAL COMMUNITIES,
IT'S DIFFICULT.
THE OTHER THING I WANT TO
MENTION THAT I HAVE A CONCERN
ABOUT IS I LOVE THE ADVANCES,
THEY ALL SOUND GREAT,
EVERYBODY'S EXCITED, WE HAVE ALL
THIS FABULOUS MOVEMENT FORWARD,
WHAT I'M CONCERNED IS THERE ARE
STILL COMMUNITIES WHO ARE NOT
GETTING BASIC SCREENING WHO ARE
FALLING EVENT FURTHER BEHIND IN
TERMS OF UNDERSTANDING WHAT'S
GOING ON IN SCIENCE EVEN AI, AS
I SAY TO THE AI EXPERTS YOU
AREOT TENTH FLOOR AND CONSUMERS
AND PATIENTS ARE ARE IN THE
BASEMENT ABOUT WHAT THE HECK AND
AI AND HOW DOES IT INTERSECT IN
THEIR LIVES, SO COMMUNITY IS
CRUCIAL TO MAKING THAT BRIDGE OR
CONNECTION, WHAT ARE YOU GOING
TO DO ABOUT EDUCATION AND TO
MAKE SURE THE BASIC FOCUS ON
THESE SAME OLD STANDARDS AND
SAME OLD SCREENINGS ARE GOING TO
STILL BE FRONT AND CENTER FOR
NCI BECAUSE I'M VERY CONCERNED,
WE'RE ALL RUSHING THIS WAY AND
WE'RE LEAVING--I THINK THAT'S
WHERE FOR EXAMPLE, THE NATIONAL
CANCER PLAN IS INKRED EBLLY
HELPFUL, IT KEEPS US BALANCED,
AND PREVENTION AND EARLY
DETECTION ARE 2 GOALS AND
DEVELOPING ADVANCED THERAPEUTICS
IS ONLY 1, SO, IT IS FRONT OF
MIND AND IT IS IMPORTANT PART OF
WHAT WE DO IN THE RESEARCH SPACE
AND TO THE OTHER POINT, I THINK
EVERYTHING IS ON THE TABLE, I
DON'T KNOW IF YOU WERE AT THE
COMMITTEE YESTERDAY, WHERE WE
TALKED ABOUT THE PRAGMATIC LUNG
TRIAL, THAT WAS AN EXAMPLE WHERE
THEY REALLY--THE PUSH OF THE
TBROWP WAS HOW LOW COULD YOU GO
IN TERMS OF DATA COLLECTION BUT
ALSO THE CONSENT FORM AND JIM,
THE CONSENT FORM AND 8 PAGES
LONG.
RIGHT.
AND AVAILABLE IN SPANISH, RIGHT?
SO I THINK WE NEED TO BE ABLE TO
THINK ABOUT HOW WE REACH OTHER
COMMUNITIES AS WELL, YOU KNOW WE
KNOW THERE ARE A LOT OF LANGUAGE
ISSUES, AS WELL AS JUST THE
BARRIERS OF THE CONCEPT PROCESS.
>> OKAY, WE HAVE 1 MORE AND WE
REALLY ARE TO MOVE ON.
>> WONDERFUL PRESENTATION NPULL
IT CLOSER.
>> SO APPRECIATE THE TBRAIT
PRESENTATION AND I WAS ALSO
PLEASED TO SEE YOU HIGHLIGHT
FLOABAL BURDEN THERE, IT'S VERY
IMPORTANT FOR US, AND AS WE ALL
KNOW THERE'S A
DISPROPORTIONATELY GROWING
[INDISCERNIBLE] AND THIS IS
RELEVANT TO US FOR JUST A COUPLE
REASONS.
ONE THING WITH YOUNG PEOPLE, BUT
FOR 1 THING OUR YOUNG PEOPLE
HAVE A REALLY STRONG APPETITE
AND THEY'RE OFTEN WITH GLOBAL
HEALTH AND CANCER EQUITY AND
ALSO UNDERSTANDING TUMOR
BIOLOGY, TUMOR GENOMICS AND
[INDISCERNIBLE] GENETICS IS
RELEVANT TO THE DIVERSE
POPULATION IN THE UNITED STATES,
BUT THERE'S A MIXED PICTURE IN
TERMS OF FINANCIALLY SUPPORTED
FLOABAL CANCER CONTROL EFFORTS
AND LOWER INCOME COUNTRIES, ON
THE 1 HAND U.S. DOLLARS GO A
LONG WAY, FROM COUNTRIES WITH
THE PROVIDING BASIC SUPPLIES,
LIKE--THESE PEOPLE CAN BE
[INDISCERNIBLE].
SO THIS' A LONG WAY WE CAN GO
THERE, ON THE OTHER HAND, THE
EXCHANGE PROGRAM ANDS GETTING
THROUGH THE RESEARCH, FROM POINT
A TO POINT B CAN BE VERY
EXTENSIVE SO I'M CURIOUS TO SEE
HOW HAVE YOU ALL THOSE ISSUES
FACTORING INTO OUR CURRENT
FINANCIAL CONSTRAINED EMPLOY.
>> YEAH, THEY'RE ALL CONSERVED
ISSUES BUT THEY WON'T BE SERVED
ABOUT IF WE BACK INTO OUR CORNER
EMPLOY WE CAN ENHANCE EACH
OTHER'S LEARNING, THE OTHER
PIECE YOU PUT IN THERE AND THE
GEOGRAPHY IS VIRMTAL EXPOSURES,
AND CLIMATE CHANGE AND THESE ARE
ALL GOING TO HAVE REAL IMPACTS
ON CANCER THAT WE'RE NOT GOING
TO BE IMMUNE FROM EITHER SO WE
NEED TO PARTNER REAL EFFECTIVELY
AND I THINK YOUR COMMENTS ARE
PROBLEM MUSIC TO DR. LAFALL'S
EARS, NTHANK YOU FANTASTIC
DISCUSSION, THANK YOU VERY MUCH.
SO NEXT ON THE AA WE HAVE THE
LEGISLATIVE REPORT BROUGHT TO US
BY MRS. HOLOHAN.
>> GOOD MORPING PLEASURE TO TALK
WITH YOU TODAY, I WILL TRY TO
GET THROUGH THIS AS QUICKLY AS I
CAN SO WE CAN HAVE SOME TIME FOR
QUESTIONS, I LET DR. RATHMEWELL,
L, GO WITHOUT TELLING ME HOW TO
DO THIS EMPLOY CAN I GET
TECHNICAL ASSISTANCE HERE,
PLEASE?
I'M USED TO SAYING NEXT SLIDE,
PLEASE.
IS THERE ANYBODY HERE?
THIS WILL BE REALLY BORING IF I
JUST TALK TO YOU.
THANK YOU.
I'M GOING TO TRY TO COVER
DETAILS THAT DR. RATISSUING
HMILL WENT THROUGH BUT I WILL
TRY TO MOVE THROUGH THEM QUICKLY
SO WE HAVE TIME WITH QUESTIONS,
OUR TEAM AND REALLY HAPPY TO
TALK TO BOARD MEMBERS OR STAFF,
WE HAVE A DETAILED LEGISLATIVE
MEETING MATERIALS THAT WILL
COVER MUCH MORE IN THE TIME WE
HAVE HERE TODAY.
IS THIS ME OR YOU?
OKAY.
ALL RIGHT.
I REALLY AM GOING TO BE ADA
DISADVANTAGE IF THE SLIDES DON'T
COME UP.
OKAY, SO, OUR APPROPRIATIONS
BILLS WERE COMPLETED VERY LATE
IN FY24.
OKAY, SO NOW I JUST PRESS THE
ARROW RIGHT IN IS THAT WHAT YOU
DID?
OKAY, TERRIFIC, TERRIFIC, OKAY.
SO WE'RE GOING TO TALK ABOUT
FY25 APPROPRIATIONS, WHERE WE
ARE RIGHT NOW, LEGISLATIVE
ISSUES TO WATCH AND A BIT ABOUT
ENGAGEMENT ADVOCACY WHICH IS SO
IMPORTANT FOR EVERYONE IN THE
CANCER RESEARCH COMMUNITY.
DR. RATHMILL GAVE YOU THE BAD
NEWS AND TALKED A LITTLE BIT
ABOUT THE FY25 REQUEST AS WELL,
SO FOR 24, WE WERE REALLY
GRATIFIED TO SEE THAT CONGRESS,
I WILL ONLY FOCUS ON THE NCI
MEMBERS HERE, AS DR. RATHMILL
EXPLAINED, THEY INKRESSED BUDGET
BY 120 MILLION THERE IS AND THIS
IS NOT INTIGER DATABASE 95 CAN'T
GIVEN THE INKRED EBLLY DIFFICULT
BUDGET CAPS THEY WERE WORKING
WITH, THE FISCAL RESPONSIBILITY
ACT WHICH WAS THE DEBT LIMIT
DEAL THAT RAISED, AND SUSPENDED
THE DEBT LIMIT UNTIL
JANUARY 21st OF 25, WE ARE
ABOUT TO FACE THAT DEBT LIMIT
ISSUE AGAIN AND IT SET FUNDING
CAPS FOR DISCRETIONARY SPENDING
FOR BOTH DEFENSE AND NONDEFENSE
AND THOSE CAPS WERE FOR 24 AND
25.
TWENTY-FOUR WAS KEPT FLAT AT THE
FY23 LEVEL, THIS IS THE TOP
LINE, NOT EACH INDIVIDUAL
ACCOUNT AND FOR 25, THERE IS A
1% INCREASE ALLOWED.
DEFENSE HAD AN INN CREASE IN 24,
THAT WAS PART OF THE DEAL AND
THERE WERE A LOT OF CHALLENGES
IN ACTUALLY IMPLEMENTING THE
DEAL.
THERE WERE KEY SIDE AGREEMENTS
REACHED THAT WERE SEPARATE FROM
THE FISCAL RESPONSIBILITY ACT
THAT GOT DEMOCRATS TO SUPPORT
THIS PACKAGE.
IT WAS SORT OF THE CHALLENGES OF
IMPLEMENTING THOSE SIDE DEALS
THAT PRESENTED A LOT OF PROBLEMS
AND WILL HAVE REVERBERATIONS FOR
FY25 WHICH I WILL COVER IN A
MOMENT BECAUSE THE MOON SHOT
FUNDING WAS ENDING WHICH WE
KNEW, BUT IT WAS ENDING IN FY23,
THAT WAS A NET LOSS OF
$216 MILLION, SO MEN WITH HIGHER
WHEN YOU LOOK AT OUR 120 MILLION
INCREASE AND OUR DECREASE IN THE
MOON SHOT FUNDS ENDING IT'S A
96 MILLION-DOLLAR SHORT FALL OF
DOLLARS IN THE DOOR OF ANY TYPE.
SO THAT'S A SIGNIFICANT
CHALLENGE FOR NCI.
HERE IS GOOD NEWS ABOUT
APPROPRIATIONS, CONGRESSMAN TOM
COLE OF OKLAHOMA BECAME THE
CHAIR OF THE FULL APPROPRIATIONS
COMMITTEE IN APRIL, CONGRESSMAN
KATE GRAINCHLER HAD STEPPED DOWN
FROM THAT ROLE IN 24.
CHAIRMAN COLE NOW IS A LONG TIME
APPROPRIATOR, HE IS A REAL
CHAMPION OF BIOMEDICAL RESEARCH,
HE HAS MET WITH ALL OF THE NCI
DIRECTORS AND PAST SEVERAL
YEARS, I AM LOOKING FORWARD FOR
DR. RARK THMILL TO MEET HIM, HE
WORKS VERY EFFECTIVELY WITH HIS
DEMOCRATIC COUNTERPARTS.
HE AND CONGRESSWOMAN ROSA DELORA
RODRIGUEZ O OF CONNECTICUT IS AN
OVARIAN CANCER SURVIVER AND LONG
TIME CHAMPION OF NE H RESEARCH.
THEY WORK VERY CONSTRUCTIVELY
TOGETHER.
THEY BOTH SERVED ON THE LABOR
HHS SUBCOMMITTEE FOR MANY YEARS,
THEY HANDED THE GAVEL BACK AND
FORTH, SHE IS THE RAIRCHGING
MEMBER.
WE DON'T KNOW WHAT'S GOING TO
HAPPEN WITH ELECTIONS OBVIOUSLY
BUT THEY WILL BE AT THE TOP OF
THOSE COMMITTEES EITHER IN THE
MAJORITY OR MINORITY.
THAT IS REALLY GOOD NEWS EMPLOY
1 THING I HAVE TALKED TO THE
BOARD AND AMERICANS ABOUT BEFORE
IS THIS OLD YOLK IN WASHINGTON
THERE'S DEMCRATING REPUBLICANS
AND APPROPRIATORS, THAT IS WHAT
CHAIRMAN COLE IS TALKING ABOUT
HERE AND IT IS A REAL BEACON OF
HOME FOR US RIGHT THOU THAT
THESE PRAGMATIC THOUGHTFUL
PEOPLE WHO CARE ABOUT RESEARCH
ARE IN THESE SPOTS, THIS IS I
QUOTE THAT DR. RAGHT MILL WHEN I
SHARED THIS WITH HER A COUPLE
MONTHS AGO, SHE WAS STRUCK BY IT
AND ASKED MOOY TO SHARE IT WITH
YOU AS WELL, THIS COMMENT THAT
CHAIRMAN COLE MADE THAT
BIOMEDICAL RESEARCH IS LIKE THE
MILITARY, YOU CAN'T CREATE IT
OVER NIGHT, YOU HAVE TO SUSTAIN
IT OVER TIME EMPLOY NOW THESE
COMMENTS, YOU HAVE TO READ FOR
YOURSELF MORE QUICKLY THAN I
READ THEM TO YOU BUT HE'S QUITE
PRESSIENT.
HE MADE THESE COMMENTS IN AN
INTERVIEW IN 2017.
SO THIS IS SOMEONE WHO REALLY
UNDERSTANDS PREPARATION AND THE
ONLY THING I WILL SAY ABOUT THE
COVID POLITICAL SITUATION PAST,
PRESENT AND FUTURE IN TERMS OF
PERCEPTIONS, THERE ARE MANY
MEMBERS LIKE CHAIRMAN COAL WHO
UNDERSTAND THAT THE REASON WE
WERE ABLE TO DEVELOP A VACCINE
IN RECORD BREAKING TIME IS
BECAUSE OF THESE SUSTAINED
INVESTMENTS AND BECAUSE OF THAT
PREPARATION AND SO WE ARE
FORTUNATE TO HAVE SUCH INFORMED
MEMBERS OF CONGRESS WHO ARE
WORKING IN NEEZ APPROPRIATIONS
ISSUES AND THEY'RE MISINFORMED
BECAUSE OF THE SCIENTISTS, LIKE
YOURSELF AND THE LEADERS OF NCI
AND NE H AND OTHER SCIENTISTS
ACROSS THE GOVERNMENT WHO HAVE
MADE IT A RORRITY TO TAKE THE
TIME TO SHOW OUR WORK.
IT IS NOT OBVIOUS TO A LOT OF
NONSCIENTISTS WHY THERE'S SO
MANY NEW TREATMENTS FOR VARIOUS
TYPES OF CANCER FOR INFECTIOUS
DISEASES FOR ALL SORTS OF
AUTOIMMUNE DECS, THIS IS NOT
OBVIOUS TO THEM, THEY HEAR FROM
PATIENTS, THEY HEAR FROM
CLINICIANS, BUT IT'S OUR YOB
CORPS TO SHOW THEM AND TO HELP
DRAW THOSE LINES ABOUT
INVESTMENT AND OUTCOMES.
THE SENATE APPROPRIATIONS
COMMITTEE HAD A HEARING ON THE
NIH FY25 BUDGET REQUEST AT THE
ENTD OF MAY EMPLOY THE HOUSE
PROARGZS COMMITTEE DIDN'T HAVE
TIME, THEY DECIDED TO MOVE
QUICKLY THROUGH THE BILL ANDS
GET TO A POINT OF NEGOTIATION,
SO THERE WAS NOT FOR FY25 A
TYPICAL HEARING.
THIS WILL PLAY OUT HOWEVER IT
DOES WITH NEW LEADERSHIP.
I EXPECT THAT IN FOR FY26 WE
WILL PROBABLY RESUME HEARINGS
BUT IT WILL DEPEND ON THE
TIMING, DR. RATHMILL,
DR. BERTAGNOLLI, AND THEIR FIRST
EXPERIENCES WITH BEING WITNESSES
ON AN APPROPRIATION HEARING, AND
OBVIOUSLY DR. BERTAGNOLLI HAD
HER SENATE CONFIRMATIONS
HEARINGS, BUT IT WAS A DIFFERENT
COMMITTEE.
OUR GROUP DID A GRIT JOB,
STRONG, POSITIVE HEARING.
A LOT OF FIRST ANDS SECONDS, I
WANTED TO POINT THIS OUT SO WE
HAVE THE SECOND WOMAN DIRECTOR
OF NCI, WE HAVE THE FIRST WOMAN
DIRECTOR OF NCI AND THE SECOND
WOMAN DIRECTOR OF THE NIH.
AND DR. JEAN MAREFRESH YOUR
RECOLLECTION RASWRRK ZO IS THE
FIRST WOMAN TO LEAD THE NIAID.
AND A LOT OF US WERE REALLY
HAPPY TO SEE THIS, THE COMMITTEE
THEY WERE TESTIFYING BEFORE IS
LED BY THE BIG CHAIR, SENATOR
PATTY CHERRY, AND COLLEAGUES, SO
I WANTED TO GET A PICTURE OF
THESE WOMEN WITH THOSE CHAIRS
BUT I FELT LIKE IT WOULD BE RUDE
TO EXCLUDE DR. GIBBONS AND
DR. HODETH, WHEN ALSO
ACCOMPANIED OUR 31st TIMERS
AND DR. NORA VOLKOW, IS A VERY
EFFECTIVE WITNESS TO GET PEOPLE
EXCITED ABOUT BRAIN SCIENCE EVEN
IF THEY'RE NOT SURE WHAT THEY'RE
EXCITED ABOUT.
THE YELLOW IBDICATES WHEN BOTH
CHAMBERS OF CONGRESS ARE IN
SESSION, BLUE IS SENATE ONLY AND
RED IS HOUSE OLD.
SO HEREY ARE IN THE 12, WE HAVE
TODAY, TOMORROW AND THE NEXT
DAY.
THEN THE HOWES GOES OFF INTO
RECESS, SO WHAT THE HOUSE IS
FOCUSING ON IS TRYING TO GET
THROUGH ALL OF THEIR SPENDING
BILLS, AND GET THEM MARKED UP BY
THE END OF JULY.
WHAT WE'RE LOOKING AT HERE THEN
IS AN ENTIRE AUGUST OFF AND IN
SEPTEMBER THERE WILL BE 3 WEEKS,
I THINK IN SEPTEMBER WE WILL SEE
IN THE LAST WEEK, CONTINUING
RESOLUTION TO KEEP THE
GOVERNMENT FUNDED, OCTOBER, NO
WORK PLANNED, THIS IS AN
ELECTION YEAR, AND SO, EVERYONE
WILL BE BACK CAMPAIGNING,
BARRING ANY EMERGENCIES THAT
WOULD REQUIRE A CONGRESS TO COME
BACK, THIS IS THEIR PLAN, SO,
THERE IS SOME MUST-PASS
LEGISLATION THAT HAS TO BE DEALT
WITH IN THIS SESSION THERE IS
THE NATIONAL DEFENSE
AUTHORIZATION ACT, THERE'S THE
FARM BILL WHICH HAS HAD A LOT OF
FIT ANDS STARTS OF PROGRESS,
THAT'S IMPORTANT IT'S DONE BY
THE END OF THE SEPTEMBER AND
THERE'S AT LEAST 1 OTHER I CAN'T
RECALL RIGHT NOW.
THE GOOD NEWS ABOUT MUST PASS
LEGISLATION IS THINGS CAN GET A
RIDE ON MUST PASS LEGISLATION
AND IT SPURS ANY ACTIVITY.
I WANTED TO POINT OUT THE LAME
DUCK CONGRESS, THE LAKE DUCK
CONGRESS STARTS ON THE 12th
AND GOES THROUGH DECEMBER.
CONGRESS WILL NOT LIKELY BE IN
WASH DURING THE CHRISTMAS WEEK,
BUT THERE'S NOT A LOT OF TIME IN
THE LAME DUCK SESSION, SO WHAT
WILL HAPPEN WITH FY25
APPROPRIATIONS?
WE KNOW IT WILL START THE YEAR
IN A STOP GAP BUT WHERE WILL IT
END.
CHAIRMAN COAL SAID THERE WILL BE
A CR SO I FEEL COMFORTABLE
SEEING THAT.
THE OUTCOME OF ELECTIONS WILL
DETERMINE WHAT GETS DONE IN THE
LAME DUCK BUT IT IS IMPOSSIBLE
TO PRO DICT HOW.
IN BOTH 20 AND 22, ALL 12
SPENDING BILLS WERE ENACTED
DURING THE LAME LUCK, SO MAYBE
THAT TELLS YOU THERE WAS
MAIORITY CHANGES AND THOSE WHO
WERE IN THE OUTGOING MAIORITY,
IT WAS THEIR LAST CHANCE TO
INFLUENCE SPENDING LEVELS, IN
2016 AND 18, AND 11 BILLS WERE
RESPECT TD AFTER THE LAME DUCK,
SO BY THE NEXT CONGRESS, THE
118th CONGRESS AND THE END OF
DECEMBER, SO 119th IS STARTING
BEGINNING OF JANUARY.
I HAVE NO IDEA WHAT'S GOING TO
HAPPEN WITH 24, HERE'S A GRAPH,
I TRIED TO COME UP WITH SCIENCE
AND DATA TO SHOW SCIENTISTS AND
I DON'T THINK A LOT OF PEOPLE--I
MEAN IT'S A RANDOM PATTERN, SO
THE BLUE BARS ARE BEFORE THE
LAME DUCK SESSION, ORANGE IS
DURING THE LAME DUCK SESSION AND
GREEN IS AFTER THE LAME DUCK
SESSION, OTHER THAN THE EXTREMES
AT BOTH ENDS I CAN'T REALLY
PREDICT ANYTHING HERE AND GIVEN
THAT I THINK I WON'T SPEND A LOT
OF TIME ON THIS BUT IN CASE YOU
NOTICE THAT THE FIRST COUPLE OF
COLUMNS UP TO 204 ARE TALLER
THAN ALL THE SUBSEQUENT 1S THEY
GOT RID OF 1 OF THE
SUBCOMMITTEES, THERE USED TO BE
13 AND NOW THERE ARE 12, THERE
ARE LEGISLATIVE ISSUES TO WATCH
AND THIS IS WHY MUST PASS
LEGISLATION IS A VEHICLE FOR
THESE PROVISIONS AND I WANT TO
POINT THAT OUT.
TELEHEALTH, WE REALIZE HOW
IMPORTANT THAT IT IS TO
EFFICIENCY, TO COST SAVING
CONVENIENCE FOR PATIENT ANDS
SOME IMOGRAPHIC AREAS IT'S
ESSENTIAL TO PROVIDE
OPPORTUNITIES, CONGRESS IS
PAYING A LOT OF ATTENTION TO
THAT, THE EXTEBDERS THAT WERE
PUT IN PLACE DURING THE PUBLIC
HEALTH EMERGENCY EXPIRED AND
THEY'VE BEEN EXTENDED BUT NOT
PERMANENTLY AND THOSE HAVE BE
DEALT WITH MY THE END OF THE
YEAR.
DRUG SHORTAGES IS SOMETHING THAT
OBVIOUSLY HAS BEEN A BIG CONCERN
OVER MULTIPLE YEARS AND
DIFFERENT CYCLES OF SHORTAGES,
HHS RELEASED A WHITE PAPER ON
THIS, CONGRESS CONDEMN PLATING
SEVERAL SORTS OF LEGISLATIVE
SOLUTIONS, WE MIGHT SEE SOME
LEGISLATION ABOUT THAT, MOVING,
THERE'S ATTENTION TO CLENICAL
TRIALS, POINTS OF ACCESS, AI IS
OF COURSE OF INTEREST, LOTS OF
CONCERNS ABOUT ITS POTENTIAL FOR
ABUSE AND POTENTIAL FOR REAL
IMPROVEMENT, NOOH H SPECIFIC
LEGISLATION, I JUST PUT THIS ON
AS A CATEGORY BECAUSE YOU MAY
HAVE HEARD ABOUT SOME OF THE
CURES ACT, HERE'S 200,
[INDISCERNIBLE] IN HOUSE AND A
REPUBLICAN COUNTERPART LARRY
[INDISCERNIBLE] FROM INDIANA
THEY WERE TRYING TO THINK ABOUT
CREATIVELY WHAT CAN THEY DO THAT
MIGHT BE HELPFUL TO BIOMEDICAL
RESEARCH AGENCIES ACROSS THE
BOARD AND REGULATORY AGENCIES IN
THE SENATE, SENATOR BILL KASES
EDUCATIONALY OF LOUISIANA, IS
LOOKING AT SOME ISSUES ABOUT NIH
AND HOPING TO REALLY I THINK BE
A HELPING FACTOR, POSITIVE
FACTOR IF TRYING TO LOOK AT
REAUTHORIZATION IN WAYS THAT
MAYBE WE CAN IMPROVE
TRANSPARENCY SO THOSE ARE ALL
MORE NASCENT EFFORTS AT THIS
POINT, SO WE WILL BE WATCHING
THOSE, IT MAY BE THE 119th
CONGRESS WHERE WE SEE ACTIVITY
THERE, AND I WANT TO HIGHLIGHT
AND RECOGNIZE SOME REAL EFFORTS
PUT FORTH BY A LOT OF PEOPLE
WITHIN THE CANCER RESEARCH
COMMUNITY, MANY OF YOU, MANY OF
YOUR COLLEAGUES WHO HAVE
PARTICIPATED IN THINGS LIKE
COLLABORATIVE HILL DAYS, IT'S
JUST A PICTURE OF FROM THIS MOST
RECENT HILL DAYS THAT ACI AND
ACR COLLABORATED ON, THERE WAS
ALSO THE RELEASE OF HEALTH
DISPARITIES REPORT THAT
DR. SONIA SPRING FIELD WAS
HEAVILY INVOF INDEED AND
REPRESENTED NCI AT A
CONGRESSIONAL BRIEFINGS BEFORE
THIS HILL DAY THAT WAS REALLY
WELL ATTENDED AND HERE'S ANOTHER
1, GROUPS OF ASCO MEMBERS AND
DR. REFRESH YOUR RECOLLECTION
ATHMILL HAS BEEN SPENDING A LOT
OF TIME ENGEAJING IN THESE
EVENTS WITH OUR TEAM AND OUR
ADVOCACY RELATIONS COLLEAGUES.
IT'S IMPORTANT FOR THESE LEADERS
TO BE ABLE TO MEET THE LEADERS
OF THESE AGENCIES AND
EN--STRATEGIESITUTES.
THIS IS JUST A PICTURE I WANTED
TO SHOW YOU OF DR. RATHMILL
MEETING WITH SENATE
APPROPRIATORS AND SHE HAD
ALREADY WORKING WITH SENATOR
BALD WIN AND I WANTED TO LIE
THIS, SHE MET WITH CONGRESSMAN
JIM MORELLI, DEMCRATE FROM THE
ROUGH ATOM CHESTER NEW YORK AND
IT WAS A VERY POSITIVE MEET XG I
PULLED OUT A PIECE OF THE TWEET
THAT HIS OFFICE PUT OUT AFTER
THE MEETING, HE LOST HIS
DAUGHTER TO TRIPLE NEG5 BREAST
CANCER IN HER 30 ANDS IT WAS A
VERY POSITIVE KREVERGZ AND HE
SAYS THE FIGHT AGAINST CANCER IS
DEEPLY PERSONAL FOR ME, THAT'S
WHEN HE MEANS, BUT CANCER SUCH
AS EVERYONE IS FOR EVERYONE, AND
DEMON TRAIT THE VALUE OF WHAT
THESE INVESTMENTS ARE AND WHEN
YOU'RE ASKED TO MEET WITH
MEMBERS AND SHARE YOUR EXPERTISE
WHETHER IT'S ABOUT LEGISLATION
OR JUST TO HELP THEM WITH AN
ISSUE THEY MIGHT BE HAVING WITH
THEIR FAMILY OR CONSTITUENT,
PLEASE DO THAT AND PLEASE, YOU
KNOW LET US KNOW IF THERE ARE
WAYS WE CAN BE HELPFUL TO YOU
BECAUSE THIS IS A COMMUNITY
EFFORT.
EVERYONE HAS A ROLE IN TRYING TO
BRING THIS MESSAGE AND MAKE SURE
CONGRESS REALLY HAPPENEDS WHAT
THEY'RE GETTING FOR THEIR
INVESTMENT.
I DON'T KNOW IF WE HAVE TIME TO
TAKE QUESTIONS, DOCTOR, YOU TELL
ME?
>> ANY QUESTIONS IN.
>> MARRIAN CORONADO FROM THE
UNIVERSITY OF ARIZONA, THANK YOU
FOR THIS UPDATE, IT'S ALWAYS
SOMETHING I LOOK FORWARD TO AT
THESE MEETINGS, I WANT TO ASK
ABOUT MOON SHOT, SO I KNOW THAT
IT DID GET INCLUDED IN THIS
YEAR'S BUDGET IT SOUNDS LIKE
THERE'S A POSSIBILITY THAT IT
GETS INCLUDED IN FUTURE, HOW
SHOULD WE BE THINKING ABOUT MOON
SHOT AND ANSWERING PEOPLE'S
QUESTIONS.
>> IT'S A GOOD QUESTION.
SO THE CANCER MOONSHOT THAT WAS
DRAFTED AND FUNDED THROUGH THE
21st CENTURY CURES ACT, THAT
WAS A 7 YEAR STREAM OF FUND
THAGOREAN KIND OF WENT LIKE
THIS, CONGRESS DID IN FY20 WE
HAD A DROP IN FUNDING FROM
400 MILLION TO 492 MILLION, THAT
YEAR THEY WERE ABLE TO FILL IN
THAT GAP THROUGH OUR BASE BUDGET
WHICH WAS REALLY WONDERFUL AND
WE WERE HOPEFUL BUT PRACTICALLY
REALIZE THEY JUST DIDN'T HAVE
THE ALLOCATION TO DO THAT FOR
FOOTWORK Y24.
I CERTAINLY THINK THERE WAS THE
INTEREST IN DOING IT.
WHAT I THINK YOU MIGHT BE
REFERRING TO IS THERE'S
PROPOSALS FOR MANDATORY FUNDING
FOR 1.4 FOR 8 BILLION FOR THE
CANCER MOONSHOT.
THAT IS INTENDED TO SUPPORT THIS
REALLY BROAD EFFORT TO ACHIEVE
THE GOALS OF DECREASING
MORTALITY BY 50% IN 25 YEARS.
THAT REQUIRES A REALLY
SIGNIFICANT INVESTMENT,
MANDATORY FUND SUGGEST
NONAPOPTOTIC PROVIDED THROUGH
THE APPROPRIATE ALLOCATIONS,
IT'S PROVIDED THROUGH
LEGISLATION THAT'S AUTHORIZING
LEGISLATION, SO IT DOES SIGNIFY
AN IMPORTANT PRIORITY FOR THE
ADMINITRATION AND SOMETHING
THOSE GOALS ARE AS REAL TO US AS
THEY WOULD BE WITH ANOTHER PIECE
OF LEGISLATION, THE ISSUE IS
REALLY WOULD CONGRESS BE ABLE TO
IDENTIFY SOURCES OF MANTIS
SHRIMPATORY FUNDING IN A
DIFFICULT TIME, BUDGET CAP YEAR,
SO 24 AND 25 ARE PROBABLY REALLY
CHALLENGING YEARS IF ARE THAT TO
HAPPEN EMPLOY TIMES IT TAKES
MORE THAN 1 ATTEMPT TO GET
SOMETHING LIKE THIS MOVING.
AND I HAVE BEEN SURPRISED BY A
LOT OF THINGS CONGRESS HAS BEEN
ABLE TO DO WHEN THERE'S ENOUGH
MOMENTUM BUT I THINK WHAT WE
NEED TO DO IS SORT OF STAY
FOCUSED ON GOALS AND WHAT WE CAN
DO WITH OUR EXISTING ALLOCATIONS
BECAUSE A LOT OF THOSE THINGS
ARE WORK WE'RE DOING THROUGHOUT
MANY PARTS OF OUR PORTFOLIOS AND
I THINK THAT THIS COULD BE
SOMETHING DR. RATHMILL MAY HAVE
A COMMENT ON NOW OR AT THE PRAIK
EMPLOY SO I THINK WE ARE JUST
STAYING TRUE TO THOSE GOALS AND
BEING VERY HOPEFUL ABOUT THE
FUTURE.
WE ONLY HAVE TIME FOR 1 MORE
QUESTION AND I WOULD SAY THAT WE
HAVE ADDITIONAL QUESTIONS, DO IT
DURING THE BREAK.
>> THANK YOU VERY MUCH.
SO HEARING A LOT FROM CAPITOL
HILL FOR POTENTIAL 2.0 CURES
ACT.
IS THAT REAL?
WILL THERE BE ANY APPROPRIATIONS
ASSOCIATE WIDE THAT POINT
VERSUS, THEY DID A LOT FOR US
AND FDA--
>> SO THERE WAS A QUESTION FOR
INFORMATION PUT OUT JUST LAST
WEEK I THINK FROM CONGRESS
[INDISCERNIBLE], AND CONGRESSMAN
[INDISCERNIBLE].
THEY ARE LOOKING TO SEE WHAT IN
LEGISLATION FOR CURES 2-POINT 0
OUT OF LAST LEGISLATION, ARE
THERE OTHER THINGS THAT CAN BE
DONE, APPROPRIATORS AND
AUTHORIZERS ARE LOOKING AT WHAT
CAN WE DO THAT IT'S HELPFUL TO
AGENCIES TO HELP ACHIEVE THESE
GOALS, FUNDING ASIDE, THAT'S
FUND SUGGEST 1 PART, BUT THERE'S
ALSO OTHER OPPORTUNITIES, OTHER
FLEXIBILITIES, OTHER THINGS WE
CAN DO AND THOSE ARE SOME OF THE
QUESTIONS THAT WE HAVE GOTTEN
AND THAT HAVE COME TO DR. RARK
THMILL AS SHE'S TAKEN OVER AT
NCI, SO I DON'T KNOW WHAT'S
GOING TO HAPPEN WITH THAT, I
DON'T THINK THAT WOULD BE
SOMETHING WE WOULD EXPECT IN SAY
THE FIRST 3 MONTHS OF THE NEXT
CONGRESS AND I THINK WE'RE
LOOKING AT THE 119th AND WE
WILL HAVE TO SEE HOW THE NEWS--
>> LAST THING WE HAVE A PLANNING
AND BUDGETING COMMITTEE, IT'S A
VERY EXCITING COMMITTEE IF YOU
WANT TO YOIN, IF YOU HAVEN'T
JOINED YET, WE COMMITTED
DR. RATHMILL TO HELP IN ANY WAY
WE CAN.
WE HAVE LARGE SUMS OF MONEY.
>> CURES IS A VERY BIG, THEIR
FOCUS IS VERY BROAD, SO NIH IS
PART OF IT, BUT NOT ALL OF IT.
SO, THERE WILL BE MORE ON THAT
TO COME, I THINK.
THANK YOU VERY MUCH.
NTHANK YOU VERY MUCH.
>> SO MOVING ON WE HAVE
RECOGNITION OF RETIRING BSA
MEMBERS.
DR. RATHMELL.
>> SO WE HAVE 2 BSA MEMBERS WHO
ARE RETIRING IN THIS CYCLE,
NEITHER ARE HERE TODAY, SO I'LL
BE FAIRLY BRIEF BUT WE DO HAVE
DR. SYLVIA [INDISCERNIBLE] UP
HERE, SO, SHE HAS BEEN A BIG
CHAMPION FOR OUR TALK ABOUT--I
LOST HER, I WILL LOOK AT YOU
GUYS, DATA AI, SCIENCE, SO
SYLVIA IS THE DIRECTOR FOR THE
AI AND ASSOCIATE STANFORD CANCER
EN--STRATEGIESITUTE AND BEEN A
MARVELOUS BOARD MEMBER AND
ENJOYED SERVING ALONGSIDE HER
AND ON THIS COMMITTEE AND
RECOGNITION OF SERVICE, SYLVIA I
DON'T KNOW IF YOU CAN SEE, YOU
GET A NICE PLAQUE FOR YOUR WALL
AS FAR AS OUR FOREVER
GRATEFULNESS.
AND OUR OTHER MEMBER RETIRING
WHO CAN'T JOIN TODAY IS BOB
[INDISCERNIBLE], HE IS VICE
PRESIDENT OF CANCER PROGRAMSA
THE YRT OF PENS OPINION HE'S'
RENOWNED INVESTIGATOR IN
IMMUNOTHERAPY AND TRANSLATIONAL
RESEARCH AND GUIDING OUR EFFORTS
IN THAT SPACE SO REALLY GRATEFUL
FOR HIS EFFORTS AS WELL, SO
THANKS VERY MUCH.
>> OKAY, NEXT ON OUR AGENDA
EXCITING PRESENTATION ON
HIGHLIGHTS OF THE CENTER FOR
CANCER DEGOMMICS THAT WILL BE
BROUGHT TO US BY DR. LOU STOUT
WHO SERVES AS DIRECTOR FOR THE
CENTER FOR CANCER GENOMICS, AND
CANCER RESEARCH AND ALEX
[INDISCERNIBLE], PROFESSOR
INSTITUTE PER MEDICAL
ENGINEERING AND SCIENCE AND
DEPARTMENT OF CHEMISTRY AND
DIRECTOR FOR HEGHT INNOVATION
CLUB.
LOU?
NTHANKS, JOHN.
SO WHEN KIM ASKED MOOY TO DO
THIS, KNOWING HER PREDELICATION
FOR PRESENTATIONS I COULDN'T
POSSIBLY TELL YOU ABOUT ALL
WE'RE DOING IN THE CENTER FOR
CANCER GENOMICS, WE'RE THE
STEWARDS OF THE TCGA COLLECTION
OF TUMORS, WE CONTINUE TO WORK
ON THAT.
WE RUN THE NCI GENOMIC DATA
COMMONS THAT HAS A HUNDRED
THOUSAND UNIQUE VISITORS EVERY
MONTH BUT I'M GOING TO TELL YOU
TODAY ABOUT A RESOURCE THAT
WE'VE DEVELOPED THAT YOU MAY OR
MAY NOT HAVE HEARD OF, A NEXT
GENERATION CANCER MODELS AND
THEN END WITH WHAT WE MIGHT DO
WITH ALL THESE.
SO AS CANCER BIOLOGISTS, WE WE
NOW HAVE A NEW FRAMEWORK TO
THINK ABOUT CANCER COMING OUT OF
TCGA AND MANY OTHER EFFORTS IN
TERMS OF SUBTYPES OF CANCER AND
IN PARTICULAR DRIVERS OF CANCER
THAT COME FROM THAT, AND THE
NEXT UP FOR CANCER BIOLOGIST IS
TO HAVE A MODEL.
NO MODEL, NO DISCOVERIES, AND
WAWE WOULD DO WITH THIS MODEL IS
A LOT OF THE THOUGHTS ARE WHAT I
DO IN MY LAB ON LYMPHOMA BUT
GENERALLY ARK PLICCABLE WE WILL
TAKE A FUNCTIONAL APPROACH AND A
FUNCTIONAL DENATIONAL LIBRARY OF
MEDICINICS APPROACH WOULD NOT BE
TO FOCUS ON 1 YEEN AND ALL THE
YEENS WE USE RNAi CRISPR,
SMALL MOLECULES OR LIBRARIES OF
MUTANT OPEN READING FRAMES AND
WE WOULD USE THIS TO COVER
ESSENTIAL AND POTENTIALLY
DRUGGABLE PATHWAYS THAT WE WOULD
HOPE TO LEAD TO COMBINATION
THERAPIES OF CANCER.
SO THINKING ABOUT THESE MODELS
THEN, THERE ARE DEFICIENCIES IN
OUR CURRENT COLLECTION.
THEY TYPICALLY WE DO NOT HAVE
THE PRIMARY TUMOR FROM WHICH THE
MODEL WAS DEVELOPED, SO WE DON'T
KNOW IF IT'S DRIFTED OR
OTHERWISE QUITE DIFFERENT.
THERE'S USUALLY NO CLINICALLAN
OITATION ASSOCIATED WITH THE
MODEL.
WE DON'T KNOW HOW THE PATIENT
RESPONDED TO THERAPY.
THERE IS AS YOU KNOW, THERE ARE
COMMON RECURRENT DRIVER
MUTATIONS AND THERE ARE LESS
COMMON 1S AND FOR MANY OF THE
LESS COMMON MUTATIONS WE MAY NOT
HAVE ANY EXISTING MODELS IN THE
UNIVERSE TO TO STUDY THAT WHICH
IS CLINICALLY IMPORTANT FOR THE
PATIENT WHO HAS THAT TUMOR
DRIVEN BY THAT RARE EVENT
THERE'S QUITE A BIT OF RARE
CANCER TYPES, DIFFERENT TYPES OF
SARCOMA FOR EXAMPLE, WE MAY MOT
HAVE A SINGLE MODEL OR VERY
UNDERREPRESENTED SET OF MODELS
AND FINALLY WE DONE KNOW WHETHER
THE MODELS WE HAVE RACAPITTULATE
BOTH THE PHENOTYPIC VARIATION
THAT IS A HUGH MAN TUMOR AS
LOS ANGELES AT SUBCLONAL
VARIATION THAT IS IN THE TUMORS
SO THE GOAL WAS TO CREATE A NEW
NEXT GENERATION CANCER MODELS
THAT WOULD HAVE FULL GENOMIC AND
CLINICAL CHARACTERIZATION AND
THIS IDEA CAME TO ME AT AN ACR
MEETING 2015, 14--I CAN'T
REMEMBER BUT THE SPEAKER I DO
REMEMBER IT'S HANZ CLAYBURRS AND
HE TOLD ME ABOUT HIS NEW
ORGANOID TECHNOLOGY, I AND I
HEARD IF TR THE FIRST TIME AND I
WAS EXCITED AND --I PITCHED IT
TO HAROLD VARMIS AND HE SAID GO
FOR IT AND WE HAVE LAUNCHED THEN
AND CARRIED OUT THIS HUMAN
CANCER MODELS INITIATIVE HCMI
AND IN THIS WE USED ALL THESE
NEW METHODS THAT WE GENERATED
ORGANOIDS, NEUROFEARS,
ADDITIONALLY REPROGRAM CELLS AND
THEN WE DISCOVERED IN THE
PROCESS THAT YOU CAN MIX AND
MATCH FORMULATIONS AND SOMETIMES
GET CERTAIN THINGS TO GROW IN
THE LABORATORY THAT YOU WOULDN'T
OTHERWISE, AND SO ALL THESE
MODELS THEN WOULD COME ALL RIGHT
ANNOTATED WITH WHOLE GENOME
SEQUENCING, RNA-SEQ AND
METHODALATION ANALYSIS AND
IMPORTANTLY ANOTHER DIFFERENCE
IS THAT THEY WERE ALL COLLECTED
IN A PERSPECTIVE WAY WITH
INFORMED CONSENT AND WE HAD
STANDARDIZED CASE REPORTS AND
ALSO HAD DEMOGRAPHICS BUT ALSO
HAVE RESPONSE TO THE PATIENT TO
THE TREATMENT THEY RECEIVED RIDE
AFTER THAT BIOPSIES WAS TAKEN
AND OUR MEDIAN FOLLOW UP IS 1
AND HALF YEARS SO ALL OF THIS IS
A PACKAGE THAT COMES WITH THESE
MODELS SO WHAT WE DID AS NCI IS
WE SET UP SEVERAL SITES AROUND
THE COUNTRY AND OUR GOAL WAS TO
MAKE A THOUSAND HUMAN CANCER
MODELS.
WE EVAPORATE QUITE GOTTEN THERE
YET, AND THEN WE WOULD BANK
THESE CELL LINES, WE TURN THE
CELL LINES INTO DATA, AND WE
HAVE SEQUENCING NOT JUST OF THE
CELL LINE BUT ALSO THE PRIMARY
FROM THE SAME CLINICAL PATIENT
AND THEN THE CLINICAL DATA WOULD
GO TOGETHER AND THIS WOULD BE
DISTRIBUTED RESEARCHERS THROUGH
A PARTNER WHICH IS ATKRRK CWHICH
IS 1 OF THE MOST TRUSTED
PROVIDERS OF QC'D CELL LINES IN
THE WORLD AND I USE THEM ALL THE
TIME IN MY OWN RESEARCH.
SO HERE ARE SOME OF OUR CANCER
MODEL DEVELOPMENT CENTERS CHIEF
INITIALLY WAS THE BROAD
INSTITUTE AT COLD HARBOR WITH
DANA-FARBER AND WE ADDED ON
STANFORD AND CORNELL AND
PARTNERSHIP WITH THE UNIVERSITY
OF RONA THAT WAS DOING SOME OF
THIS AND THEN I HEARD THAT THE
SANGER INSTITUTE WAS DOING
REALLY THE SAME INITIATIVE AND
SO WE PARTNERED THEN IN AN
INTERNATIONAL COLLABORATION AND
BROUGHT THEIR MODELS IN AND THEN
ALL THESE MODELS ARE PROFILED IN
THE UNIFORM WAY THROUGH
CONTRACKS THAT WE MANAGE IN THE
CENTER FOR SEQUENCING AT THE
BROAD INSTITUTE AT UNC AND
BIOSPECIMEN REPOSITORY AT
NATIONWIDE CHILDREN'S HOSPITAL
AND FINALLY THE MANAGEMENT AND
DATA ARE COORDINATED AT THE NCI
IME NATIONAL LIBRARY OF
MEDICINIC DATA COMMONS AT ATCC,
AND WE'VE HAD A LOT OF HELP FROM
THE FREDERICK NATIONAL LABS AND
THE IMS FOR CLINICAL DATA
CURATION, SO SO FAR WE MADE 743
MODELS AND 307 OF THEM HAVE
ALREADY BEEN LAUNCHED THROUGH
ATCC, CAN YOU BUY THEM A LITTLE
INSIDER TIP, DON'T GET STICKER
SHOCK WHEN YOU GO TO THE ATKRRK
C WEBSITE, IT WILL LOOK REALLY
EXPENSIVE, THEY--I CAN'T MAKE
THEM BUJ OFF THIS, THE PRICE FOR
ACADEMICS IS LESS THAN HALF OF
WHAT YOU WILL SEE, SO, BUT THEY
DON'T WANT TO ADVERTISE THAT,
SO, HERE I AM ON NATIONAL
TV--NO, BUT LETTING THEM KNOW
THEIR BUSINESS SECRETS.
SO OUR MODELS, WE HAVE A LOT OF
MODELS FROM THE COMMON TYPE OF
CANCER, BRAIN CANCER, TBLI O
BLASTOMAS, ESPECIALLY PANCREAS,
A LOT OF GASTRO-ESOPHAGEAL
TUMORS AND THEN A LONG TILE OF
SOME VERY RARE TYPES OF CANCER
THAT WE HAVE NEW MODELS, TIMES
THE FIRST MODEL, THE FIRST
MODELS OF ANCHLIO IMMUNO BLASTIC
T-CELL LYMPHOMA FOR EXAMPLE, NO
MODEL EXISTED.
WE CHARACTERIZE THE IME NATIONAL
LIBRARY OF MEDICINICS AND HERE
JUST SHOWING THAT WE HAVE THE
COMMON DRIVER ALTERATIONS AT THE
GENETIC LEVEL AND WE'VE ALSO
LOOKED AT THE TRANSCRIPTOMICS,
AND HERE IS THE DISPLAYED IN A
UNAP PROJECTION, THE YEEN
EXPRESSION FROM SORT OF A
SCAFFOLD SHALL WE SAY OF TCGA
SAMPLES AS WELL AS THE EXISTING
CCLE SET OF CELL LINES AND ON TO
THE SCAFFOLD WE LAYER, THE HCMI
TUMORS AND THE HCMI MODELS, AND
SO WHAT I WANT TO EMPHASIZE IS
THAT IN SOME CASES FOR EXAMPLE,
IN THE GBM SPACE,EUR NEW MODELS,
THE HCMI MODELS ARE IN THE LARM
CLOUD OF TCGA TUMORS THAT ARE
GBMs, WHEREAS THE PREVIOUS
CCLE MODELS ARE OFF BY THEIR
LONESOME IN A LITTLE SPACE SHOWN
BELOW.
SO MAYBE THESE ARE SOMEWHAT
BETTER MODELS OF GBM WORK THAT
WILL BE NEEDED.
NOW I WILL TURN IN THE SECOND
FEW MINUTES, TO HOW WE MIGHT USE
THESE MODELS, AND NOW THINK
ABOUT NEXT GENERATION CANCER
SIGNALING NETWORKS.
AND PREDICTIVE CANCER
THERAPEUTICS.
SO LAST NIGHT, I SAID OKAY,
WHO'S MY AUDIENCE HERE AND I
LOOK AT THE ROSTER AND I SEE
TREY [INDISCERNIBLE] IN THE
AUDIENCE AND A LOT OF WHAT I
WILL TELL YOU HE CAN BE GIVING
THIS TALK BETTER THAN I, BUT
NONETHELESS, MAYBE WE GET A
QUESTION FROM TREY.
SO THE PROBLEM, THE PROBLEM IS
THAT OF COURSE MONOTHERAPY, YOU
HAVE GREAT TARGETED DRUGS THANKS
TO THE PHARMACEUTICAL INDUSTRY
BUT AS MONOTHERAPY, THEY ARE A
LITTLE BIT OF SUCCESS,
RESISTANCE EMERGING ALMOST
IMMEDIATELY IN SOME CASES, WE DO
HAVE COMBINATION THERAPIES, SOME
OF THEM EFFECTIVE BUT THEY'RE
LARGELY, I WOULDN'T SAY
EXCLUSIVELY BUT LARGELY IM
PERICAL AND NOT BASED ON A DEEP
KNOWLEDGE OF NETWORK REGULATORY
NETWORKS IN PARTICULAR CANCER
TYPES.
AND IN PARTICULAR OUR CURRENT
IDEAS ARE SORT OF VANILLA, THAT
IS THEY'RE THE SAME NETWORK
EVERYWHERE, WHEREAS WE KNOW THAT
EACH CANCER TYPE COMING FROM A
DIFFERENT TYPE OF PRIMARY CELL
WILL HAVE A DIFFERENT
EPIIMENETTIC SET POINT THAT WILL
CHANGE ITS CANCER NETWORK, THERE
WILL BE AN INFLUENCE OF
ONCOGENIC ALTASD RAYINGS ON
THOSE NETWORK ANDS THEN THERE'S
A NETWORK REDUNDANCY FEEDBACK
CIRCUITS AND JUST GENERAL
COMPLEXITY THAT HAS NOT BEEN
DEALT WITH.
FURTHER MORE, OUR MODELS
TYPICALLY ARE DESCRIPTIVE BUT
THEY HAVEN'T BEEN USED EXCEPT IN
SOME CASES TO BE PREDICTIVE AND
ARE GENERALLY STATIC BUT NOT
DYNAMIC OVER TIME.
SO HOW DO WE APPROACH THIS, JUST
IN GRAPHICAL TERMS AND REALLY I
TOOK A LOT OF SLIDES OUT FOR
TIME, THIS IS--THIS IS THE BCR
ABLE, TARGETED BIOMAT NIB SLIDE.
REALLY OVERSOLD HOW EASY IT WAS
TO DO PRECISION MEDICINE.
MOSTLY OUR CANCERS HAVE MORE
COMPLICATED CIRCUITS AND THEN
WHEN YOU TREAT WITH MONOTHERAPY,
THE TUMOR KEEPS ON GROWING AND
SO WE WOULD LIKE TO UNDERSTAND
THESE NETWORKS WELL ENOUGH SO WE
CAN ACTUALLY PROPOSE AND TEST
COMBINATIONS THAT WILL HIT ALL
THOSE NODES AND LEAD TO CELL
DEATH.
SO WHAT I'M GOING TO SHOW YOU
NOW IS AN UNFUNDED MANDATE, NOT
OCCURRED PRIORITY OF THE NCI AND
ALL SORTS OF DISCLAIMERS, BUT
SOMETHING THAT I HAVE PITCHED
BEFORE AND WE A REALLY NICE
OUTSIDE INVESTIGATORS COME IN
FOR A RETREAT ON THIS AND WAS
WELL RECEIVED SO FAR LACK OF A
BETTER WORD, I WILL CALL IT A
FUNCTIONAL TCGA INITIATIVE AND
THE TCGA REFERS TO IT BEING A
TEAM SCIENCE ACTIVITY IN TERMS
OF A COLLECTION OF DATA ACTIVITY
AND AN IMMEDIATE DISTRIBUTION OF
SAID DATA TO THE COMMUNITY.
THERE MIGHT BE A COORDINATING
CENTER THAT WOULD PULL TOGETHER
ALL SORTS OF [INDISCERNIBLE],
AND THESE WOULD BE SMALL
MOLECULES THAT WOULD GET
PARTICULAR ESSENTIAL CANCER
PATHWAYS, CRISPR REAGENTS, ET
CETERA AND THEN THERE MIGHT
BE--AND THEN THERE'S FOR
EXAMPLE, THE COLLECTION OF HCMI
MODELS.
WE WOULD ENVISION SETTING UP
HUBS OF EXCELLENCE AROUND THE
COUNTRY THAT WERE GOOD AT CRISPR
TYPE FUNCTION WILLA,AINAL SIS,
PROTEOMIC HUBS DOING
PROTEIN-PROTEIN INTERACTION AND
PROTEIN MODIFICATION, SINGLE
CELL HUBS, CHEMICAL BIOLOGY HUBS
TO PROBE THEM IN UNIQUE WAYS AND
IMPORTANTLY CELL BIOLOGICAL
HUBS, WHERE ARE THINGS TAKING
PLACE IN THE CELL.
AND WE WOULD IMAGINE THAT 1 OF
THE MAIN ACTIVITIES OF THIS
WOULD BE A COORDINATED SET OF
EXPERIMENTS IN WHICH A
PREAIMREED UPON SET OF MODELS
WITH AN AIM IN SIGHT WOULD BE
PERTURBED WITH A SET OF
PERTERB GENERATEDS AND DATA THEN
WOULD BE CLEBBED IN
MULTIDIMENSIONAL FASHION OVER A
TIME COURSE AND THEN FED INTO
SOME COMPUTATIONAL HUBS.
SO THE WHOLE GOAL IS TO MAKE
THESE NEXT GENERATION MODELS, OF
CANCER REGULATORY NETWORKS, STEP
0 REALLY WOULD BE TO TAKE THAT
PRIMARY DATA AND IMMEDIATELY
DISTRIBUTE IT TO THE COMMUNITY,
SO WE COULD CROWD SOURCE.
EVERYBODY GETS TO PLAY WITH THIS
DATA BUT THEN WE MAY WORK WITH
OUR COMPUTATIONAL HUBS TO COME
UP WITH DETAILED WIRING DIAGRAMS
OF IRPT STELLAR PATHWAYS AND
ESPECIAL LE HOW CANCER'S CELL
TYPE DIFFERENTIATION OF ORCHG O
GENIC ALTERATIONS CHANGES THOSE
REGULATORY STRUCTURES.
WE COULD EASILY FIND, I THINK
SYNTHETIC LETHAL RELATIONSHIPS
WITH SOME OF OUR EXISTING DRUGS
SUCH THAT A PATIENT WITH A
PARTICULAR GENETIC ABNORMALITY
WOULD BE PARTICULARLY SENSITIVE
TO AN INTERVENTION.
WE WOULD HAVE NEW TARGETS AND
THESE TARGETS MIGHT LEAD TO
COMBINATION THERAPIES AND I
WOULD ENVISION EVEN AS FAR AS
TESTING THESE COMBINATION
THERAPIES WITH A LOT OF DATA
COLLECTION IN PHASE 1 CLINICAL
TRIALS, SO, AGAIN, I DID CLEAR
THIS WITH KIM AND SHE SAID IT'S
FINE AS LONG AS EVERYBODY KNOWS
THAT THIS IS FOR DISCUSSION SO
I'M HAPPY TO HAVE ANY QUESTIONS
THANKS.
>> THANKS, LOU.
>> CHAIR'S PREROGATIVE.
[LAUGHTER]
O LET'S DO THE NEXT SPEAKER,
THERE'S ANOTHER SPEAKER,
CORRECT?
>> LET'S DO THAT FIRST.
>> SORRY ABOUT THAT.
SO ALEX SHALEK, WHO YOU MAY WELL
KNOW IS SOMEONE WE FUNDED FOR
SOME OF OUR WORK IN THE CENTER
FOR CANCER GENOMICS BUT BESIDES
THAT HE'S JUST AN AMAZING
INVESTIGATOR ON HIS OWN RIGHT
AND SORT OF I WOULD SAY
MIDCAREER ALEX, AND HAS BEEN
REALLY DOING WORK THAT I THINK
RESONATES WITH WHAT I JUST GOT
THROUGH SAYING.
NTHANKS, LOU AND THANK YOU SO
MUCH TO THE OPPORTUNITY TO
PRESENT TO NCI AND EVERYBODY
THAT'S PRESENT.
I THINK THE TALK I WILL GIVE
TODAY, DOVETAILS BEAUTIFULLY ON
WHAT YOU PRESENTED AND I WILL
THROW A LITTLE FUEL ON THE FIRE
AND SAY THAT TCGA HAS MY VOTE
AND I AM WILLING TO SCREAM TO
THE HILLS FOR IT.
SO I WANT TO TELL YOU ABOUT THE
WORK WE'VE BEEN DOING RECENTLY
THAT WILL BE FOCUSED ON TRYING
TO UNDERSTAND THE RELEVANCE OF
CELL STATE AND I WANT TO TAWRG
THAT ACTUALLY WE NEED TO MOVE
FOR A PARADOIM TO WHERE WE THINK
ABOUT DNETWORKA TO 1 WHERE WE
THINK ABOUT THE RNA PHENOTYPES
AS A WAY OF SELECTING THERAPIES
FOR CANCERS.
BEFORE I START I WILL SAY I HAVE
A BUNCH OF FINANCIAL
DISCLOSURES, FOR TRANSPARENCY I
PUT THEM HERE.
WHEN WE THINK ABOUT PRECISION
MEDICINE PIPELINES WE THINK
ABOUT DNA AS A FOUNDATION FOR
IT, TRUTH IN ADVERTISING YOU
PROBABLY FOUND OUT IF I HAD A
TUMOR TOMORROW, I WOULD WANT TO
SEQUENCE IT SO I COULD FIND OUT
WHAT MUTATIONS EXISTED IN NIGH
DNA SO WE COULD MAKE THE TYPES
OF MODELS WE WERE TALKING ABOUT
AND AND BY CONFIRMING THE
MUTATIONS EXISTED, I THINK GO IN
HUGHES, ALL OF TOOLS THAT WOULD
BE ABLE TO FIGURE OUT WHICH
DRUGS WOULD BE ACTIONABLE
AGAINST SPECIFIC MUTATIONS AND
THIS IS SORT OF THE PROMISE OF
GENOMICS WHERE WE CAN GO AND
FIGURE OUT WHAT HAS CHANGED THAT
MAKES A TUMOR DIFFERENT FROM
CELL AND SPECIFICALLY GO AFTER
IT THROUGH INDIVIDUAL DRUGS OR
COMBINATIONS THEREOF.
SO I MIGHT ASK HOW HAVE WE DONE
WITH ALL THE ADVANCES IN
DENOAMICS AND I WOULD SAY
UNFORTUNATELY WE WOULDN'T HAVE
DONE AS WELL AS WE LIKE, THERE
ARE ONLY A NUMBER OF MUTATIONS
THAT HAVE ACTUAL MUTATIONS,IME
SURE YOU'RE AWARE, 40% OF THEM
ONLY A SMALL FRACTION HAS
RESPONSES, SO VERY OFTEN WE
INVOLVE SYSTEMS WHICH MAKES THE
TREATMENT NO LONGER VIABLE BUT
WHEN WE THINK ABOUT WHY THIS
PIPELINE MIGHT FAIL, AT THE
CENTER OF IT IS THIS IDEA THIS
DNA ALTERATIONS ARE THE ONLY
THINGS THAT ARE RELEVANT FOR
CONTINUING ABOUT DRUG
SENSITIVITY, SO IF WE THINK
ABOUT WAWE'RE REALLY TRYING TO
DO WITH WE CURE CANCER, WE'RE
NOT TRYING TO KILL A PARTICULAR
MUTATION, WE THINK ABOUT A LOT
ABOUT THE IDEA, PRECISION BEING
DOWN TO THE MOLECULAR CAUSES BUT
AT THE END OF THE DAY, WE WANT
TO TARGET INDIVIDUAL CANCER
CELLS THAT'S WHAT WE'RE TRYING
TO ERADIATE AND REMOVE.
IF YOU THINK BACK TO OUR HIGH
SCHOOL BIOLOGY, I'M SURE YOU ARE
ALL VERY WELL AWARE THAT WITHIN
OUR SOWRS, WE HAVE DNA AND A
STATIC PLURIBU PRINT THAT'S USED
TO MAKE A DIFFERENT CELL TYPES,
EVERYTHING FROM IMMUNE CELLS,
MUSCLE CELLS AND WHAT CHANGES,
WHAT CELL TYPE YOU GET IS NOT
THE DNA ITSELF BUT ACTUALLY A
MEMBER OF LAYERS OF REGULATION
IN THE CELL EMPLOY SO THINGS
LIKE EPIGENETICS AS WELL AS
INTERACTIONS AND THESE STATES
THAT LET YOU GET MULTIPLE
DIFFERENT CELL TYPES FROM 1
STATIC CODE LIKE READING
DIFFERENT BOOKS IN THE LIBRARY
TO GET DIFFERENT OUTPUTS NOW
WHEN WE THINK ABOUT CANCER, WE
HAVE THE SAME PLACE WHERE YOU
HAVE A MUTATED DNETWORKA CODE
BUT YOU CAN RESULT IN DIFFERENT
STATES WHICH MY BE RESPONSIVE TO
YOUR IMMUNE SYSTEM, SOME OF
WHICH MIGHT BE SENSITIVE TO
DRUG, AND SOME OF WHICH MIGHT
NOT BE RESISTANT.
SO YOU CAN ASK YOURSELF IF THIS
DNA CAN GIVE RISE TO MULTIPLE
STATES AND CAN UNDERLIE
RESISTANCE HOW DO WE FIGURE OUT
WHICH STATES EXIST?
WELL, OVER THE PAST SEVERAL
YEARS WE AND OTHER VS BEEN
INVOLVED IN DEVELOPING A NUMBER
OF TECHNOLOGIES THAT ENABLE TO
US TO LOOK AT CELLS FOR
UNPRECEDENTED RESOLUTION WHERE
WE TAKE A COLLECTION OF ISOLATED
CELLS AND LOAD THEM IN
INCREASINGLY SOPHISTICATED
DEVICES WHERE WE CAN CAPTURE
THEM AND PERFORM THE ADVANCE
MOLECULAR PROCESSING, SAY FOR
EXAMPLE, REUSING CAPTURE
REAGENTS TO GRAB ALL THE RNA,
AND A CELL IS GIIVE EVERY SINGLE
MOMENT AND SEQUENCING MEASURE
THE ACTIVITY OF 20,000 VARIABLES
IN AN INDIVIDUAL CELL EMPLOY
WHEN YOU THINK ABOUT THIS, THIS
GIVES US ABOUT A TRILLION DATA
POINTS FROM EACH INDIVIDUAL
BIOPSY WE MIGHT TAKE AS A WAY OF
THINKING ABOUT WHAT'S HAPPENING
IN CANCER AND HOW TO COUNTERACT
IT.
AND JUST TO GIVE YOU AN IDEA OF
HOW FAR THE FIELD HAS COME, IT'S
NOT JUST RNARE--ADMINISTRATIVE
AT THIS POINT, THERE'S BEEN SO
MANY INCREDIBLE DEVELOPS THAT WE
MEASURE CELLS AND WE CAN LOOK AT
WHICH REGIONS ARE BEING RED AND
THE ACCESSIBILITY LIKE LUIS WAS
TALKING ABOUT MINUTE AGO
ACCIDENT MEASURE SURFACE
PROTEINS AND DO MANY OF THESE
THINGS IN PARALLEL TO GET THESE
INCREDIBLY IMPRESSIVE AND
COMPREHENSIVE USE OF WHAT'S
HAPPENING WITHIN OUR CANCER
CELLS.
NOW WHAT THIS DOES, IT GIVES US
AN INCREDIBLE OPPORTUNITY TO
GIVE US THINGS THAT LOU WAS
TALKING ABOUT SO THIS IS A STUDY
I WILL TELL INCREDIBLY SHORT
FASHION AND THE BUNCH LINE AND
TALK ABOUT THIS OFFLINE BUT VERY
MUCH IN LINE WITH WHAT WAS JUST
PRESENTED.
WHAT WE WANT TO UNDERSTAND IS
WHAT IS A PRIMARY TUMOR LOOK
LIKE AND HOW GOOD IS THE MODEL
IN REPRESENTING IT SO WE TOOK
BIOPSIES IN CANCER WHERE THERE
ARE NO MUTATIONS BUT THERE ARE
VERY GOOD THERAPIES, WE
PERFORMED THE PROFILING WHERE WE
IMRESESSED THE EPITHELIAL LIKE
GENES AND WERE LESS AGGRESSIVE
AND ON THE OTHER SIDE WE
EXPRESSED THE BASAL LIKE GENES
THAT ARE MORE ASSOCIATED WITH
STEMS AND AS WELL THOSE THAT DID
BOTH.
IN PARALLEL WE MADE ORGANOIDS
FROM THE MATCHED SAMPLES,
CHECKED THEM OVER TIME AND
FIGURED OUT MODELS WERE SKEWED
IN VIVO AND BY GOING BACK AND
MODIFYING CULTURE CONDITIONS TO
RECREATE WHAT YOU WOULD ACTUALLY
SEE IN A PERSON, WE ARE ABLE TO
RECREATE THIS ENTIRE HIERARCHY
CELL STATES.
SO THE REASON I THINK THIS IS SO
IMPORTANT IS BECAUSE IT'S LESS
FUNCTIONAL CONSEQUENCES, SO TO
SHOW DAILY BASIS THEA TO MAKE
THIS GRANULAR, IT'S A PLOT, IT'S
A DIFFERENT THAN THE METHOD LOU
SHOWED YOU BEFORE AND WHAT I
NEED YOU TO KNOW IS EACH
INDIVIDUAL POINT IS A CELL, SO
THESE ARE CANCER CELLS THAT ARE
ORGANOIDS AND YOU HAVE THIS
EPITHELIAL LIKE CLASSICALITATEOT
RIGHT HAND SIDE AND MY MODCELL
SEVERELY BIASED TOWARDS THIS,
WHEN I ADD TGF BETA SIGNALING
MOLECULE FOUND IN THE MICROVIRMT
IN VIVO, WHAT CAN YOU SEE IS
OVERTIME MY MODEL MOVES TO
RECREATE THIS MORE INTERMEDIATE
AND BASAL LIKE STATE AND IF I
REMOVE TGF BETA THE MODEL GOES
BACK TO WHERE IT WAS PREVIOUSLY.
NOW YOU MIGHT SAY WELL THIS IS
INTERESTING, CAN YOU PLAY WITH
THE MODEL BUT WHY DOES IT
MATTER.
THE REASON IS MATTERS IS THAT
THIS DRAMATICALLY HAS RESPONSES
SO IF WE THINK ABOUT CHEMO
THERAPIES, BEFORE WE ADD TGP
BETA, AS WE ADD IT OVER TIME WE
GET A HUNDRED FOLD REDUCTION IN
HOW SENSITIVE IT IS AND IN THE
MODEL WHERE WE STRIPPED IT OUT
AND TRIPPED IT BACK, AND WE GET
THE SAME RESPONSE ORIGINALLY AND
AS WE THINK ABOUT ALTERING THE
STATES WITHIN THE SAME MODEL AND
TESTING IT, WE FIND THE
CLASSICAL EPITHELIAL LIKE STATE,
WE'RE INCREDIBLY SEPSATIVE TO
CHEMO THERAPIES, WE WERE VERY
SENSITIVE TO MAP KINASE
INHIBITORS SO THE REALLY
CRITICAL TAKE AWAIP FOR ME AT
LEAST IN THINKING ABOUT THIS IS
WHAT WE FIND IS THAT STATE
MATTER ANDS THAT IT INFLUENCES
DRUG RESPONSES AND YET THIS
ISN'T SOMETHING WE MODEL AND
THINK ABOUT WHEN WE SELECT DRUGS
FOR PATIENTS AND I THINK THIS
MAY BE VERY ABSTRACT BUT I THINK
THE EASIEST WAY ABOUT THINKING
WHATIME TELLING YOU IS THAT
ENSTED OF THINKING ABOUT DNA
MUTATIONS WE THINK ABOUT HOW
CELLS USE THEM FOR THE ACTIVITY
PATHWAY ANDS THEN WE TARGET
THOSE PATHWAYS WE CAN DO A
BETTER JOB OF KILLING CANCER
CELLS VERY MUCH LIKE LOU
PRESENTED SO YOU MIGHT MIGHT SAY
HOW DOES THIS HELP US IN
THINKING ABOUT HOW PATES MIGHT
RESPOND?
WELL OUR DATA WOULD SUGGIEST
THAT OUR PATIENTS THAT HAVE THIS
MORE EPITHELIAL LIKE STATE WOULD
BE SUSCEPTIBLE TO CHEMO THERAPY
CROSS LINKING THIS IS HOW WE
LOOK AT WHEN PATIENTS RESPOND
CLINICALLY.
WE FIND IT DOES AN INCREDIBLE
LOAMACYY GOOD YOB CORPS.
THE PEOPLE WHO HAVE RESPONSES IN
THE TUMOR SIZE THAT THOSE THAT
HAVE THE CLASSICAL LIKE STATE,
THOSE WHO GET OUTCROPPED BY THE
TUMOR BY THE 1S THAT ARE MORE
BASAL LIKE.
THIS IS AN INTERESTING PARDIME
BUT WE DON'T WANT TO JUST THINK
ABOUT HOW INDIVIDUALS IN THE
PDAK, WE WANT TO THINK ABOUT HOW
WE EXTEND THEM ACROSS THE
MULTIPLE CANCERS LIKE WHAT WE
JUST SHOWED YOU.
SO I WOULD HAVE THOUGHT ABOUT IT
LIKE A VIRTUAL MACHINE YELL
STACK WHERE WE MOVE THROUGH
WHAT'S HAPPENING IN THE BIOLOGY
IN VIVO AND WE THINK ABOUT HOW
WE CAN CREATE ACCURATE MODELS
THAT REPRESENT THE SPECTRUM OF
DIFFERENT STATES THAT WE SEE AND
THEN USE THAT SUBSTRATE FIGURING
OUT WHAT ARE THE TRITE DRUGS TO
TARGET THOSE THINGS.
SO YOU MIGHT ASK WHAT HAPPEN
FIST WE TRY TO DO THIS IN OTHER
CANCERS, IN PARTNERSHIP WITH THE
NCI, THEY HAVE BEEN TRYING TO
USE SOME OF THE TCGA SASMYS
USING A VARIANT OF THIS APPROACH
CALLED SINGLE NUCLEACE RNA-SEQ
TO SEE WHAT'S SHOVED ACROSS
MULTIDIFFERENT CANCERS.
WHEN YOU LOOK AT THIS, WE FIND
THE SAME BASAL STATE TALKING
ABOUT THE CONTEXT OF PDAC, AND
IT OCCURS IN MULTIPLE DIFFERENT
CANCERS, I WOULD LOVE TO TELL
YOU HOW WE'RE THINKING ABOUT
OPTIMIZING MODELS AND WORKING ON
TARGETS MAYBE DURING THE
QUESTION SECTION, BUT I MIGHT
ASK HOW USELESS THIS WILL BE
ACROSS CANCERS, CREATING
SOMETHING NEW WHERE WE NEED EVEN
MORE COMPLEXITY AND I THINK THE
ANSWER IS NO.
SO IF WE GO AND LOOK AT EXISTING
DATA SETS FOR DEPENDENCY, WE CAN
SEE THAT REGARDLESS OF THE
LINEAGE OF WHERE CANCER COMES
FROM, IF WE LOOK AT THE STATE WE
CAN PREDICT WHICH PROTEIN
COMPLEX TURBATIONS IT WILL BE
SENSITIVE TO, SO WE FIND
SIMILARITY IN HOUSEHOLDS AND HOW
THEY WILL RESPOND TO PARTICULAR
KNOCK DOWNS, REGARDLESS OF THE
CANCER ORIGIN, BASED ON WHAT HAD
IS THERE, MORE MESSENTERIEN
CHIMAL LIKE, SO WHAT WE'VE BEEN
BEENINGING ABOUT AT OUR
LABORATORY, IS HOW TO COMPLETE
THE SQUARE.
HOW DO WE WORK OUR WAY ACROSS
CREATING THESE VIRTUAL MACHINIAL
STACKS AND CROSS CANCERS TO
THINK ABOUT THESE CANCER
ECOSYSTEMS SO WE CAN CREATE HIGH
FIDELITY MODELS, CREATE
PARTICULAR COMPOUND ANDS THEN,
YOU KNOW GETTING BACK TO WHAT
LOU SHOWED IN PATHWAYS, BEYOND
THINKING ABOUT THE AGHT PATHWAY
IN CONCANCKER CELL AND 1
PARALLEL PACK WAIGHT, WE CAN PUT
A PAPER ON THE BIOARCHIVE AND
THINK A LOT ABOUT THE BCR ABLE
THAT LOW TALKED ABOUT, INSTEAD
WE CAN MOVE TO A PARADIGM WHERE
WE MOVE THE IMMUNE CELL, NOT
NECESSARILY TO MOVE THE CANCER
CELL BUT CONTROL THE STATE OF
THE CANCER CELL SO IT BECOMES
MORE SENSITIVE TO A PARTICULAR
DRUG CREATING THE SYNTHETIC
LETHAL OF WHICH LOU SPOKE, SO
WITH THAT I WANT TO THANK MY
TEAM TO DO THE WORK PRECEPTED
HERE AND I WANT TO THANK ALL OF
OUR FUNDERS AND ALL OUR
COLLABORATORS BUT MOSTLY I WANT
TO THANK PATIENTS AND FAMILIES,
IT'S NOT LOST ON ME THAT ALL THE
SCIENCE WE DO IS BECAUSE PEOPLE
AT THE MOST VULNERABLE POINTS IN
THEIR LIVES TAKE TIME TO PARTNER
WITH US IF THERE ARE BETTER
CURES FOR THEMSELVES AND OTHERS
THAT COME AFTER THEM AND OWE
THEM AN INCREDIBLE DEBT OF
GRATITUDE AND AN OPPORTUNITY TO
RESPECT THEIR WISHES AND MAKE
SURE WE DO THE BEST TOO CURE
OTHERS MOVING FORWARD.
WITH THAT I WILL SAY THANK YOU
FOR THE OPPORTUNITY AND WITH LOU
TAKE ANY QUESTIONS, THANKS FOR
HAVING ME THIS MORNING.
NGREAT.
THANKS, ALEX.
>> SO A LOT OF HANDS BUT I WILL
START WITH TREY BECAUSE HE WAS
CALLED OUT, PACIFICALLY AND THEN
I WILL WORK MY WAY AROUND THE
TABLE, I'M LOOKING IN BOTH
DIRECTIONS, WE HAVE ABOUT 10
MINUTES, LOTS OF QUESTIONS SO
TRY TO KEEP IT SUSSTINKT AND
TO--WE ACTUALLY HAVE NO IDEA
WHAT THE TRUE INTERRELATION IS
BETWEEN THOSE AND MAYBE A
PROJECT LIKE LOU PROPOSES CAN
HELP GET TO THE BOTTOM OF IT,
HOW MANY TRANSCRIPTIONAL CHANGES
THAT YOU OBSERVE ALEX HAVE
GENETIC LESIONS USHEDNEATH THEM.
VICE VERSA, RIGHT?
HOW MANY GENETIC LESIONS LEAD TO
HAVE AN EFFECT ON CANCER BUT
HAVE NO TRANSCRIPTIONAL
SIGNATURE, WE HAVE ANECDOTES BUT
WE HAVE NO SYSTEMATIC
ACKNOWLEDGES, THAT WOULD BE .1
AND I WILL SNEAK IN, .2, YAWN,
SORRY, I THINK THE KEY FOR
MAKING THIS MAYBE NOT AS MANY
KEYS BUT AS YOU KNOW THE HUMAN
GENOME PROJECT ALREADY WAS VERY
HARD TO SELL, BACK IN THE DAY,
AND THAT'S A MUCH SIMPLER GOAL,
THERE'S 3 BILLION LETTERS, WHAT
ARE THEY IN AND YOU'RE DONE.
SO I'M SURE PEOPLE ARE GOING TO
ASK THESE QUESTIONS, HOW YOU
EXACTLY PINPOINTING THE
DEFINITION OF THIS THING IT'S
GOING TO BE WHERE HE DIES IF IT
DIES AND RIGHT, AND SO LET'S
MAKE SURE IT'S NOT GOING TO DIE
AND A RELATION TO THAT QUESTION
IS HOW DO YOU THINK ABOUT THIS
IN RELATION TO THE
OTHER--THERE'S SIMILAR PROJECTS
OUT THERE BY NHGRI, LINX,
SOMETHING WAY IN THE PAST CALLED
THE ALLIANCE SORRY CELL
SIGNALING.
ALL OF THIS, WELL, THEY DIDN'T
HAVE THE CELL MODELS, NUMBER 1
EMPLOY RIGHT IN BUT THERE'S
OTHER DIFFERENCES THAT WILL BE
IMPORTANT TO DEFINE NTHANK YOU.
>> RIGHT, SO, NEDRA --NED
SHARPLESS THE DOCTOR WHEN I
FIRST PITCHED THIS AND TOGETHER
WE TALKED ABOUT JUST HOW YOU
WOULD ROLE IT OUT IN A WAY THAT
SEEMED PALLETTABLE AND WHAT WE
ENDED UP IS SORT OF LIKE TCGA TO
SAY I'M FIRST FOCUSING ON THIS
CANCER AND I WANT TO COMPLETELY
REDEFINE THE REGULATORY NETWORKS
IN THAT ANSWER TYPE AND THERE'S
LOTS--AND THAT IMMEDIATELY
NARROWS THE FOCUS TO A
PARTICULAR EPIGENETIC SPACE, A
PARTICULAR SET, AND I THINK
THAT'S A GOOD WAY TO FRAME THIS
WITH RESPECT TO OTHER
ACTIVITIES, I DON'T THINK PEOPLE
ARE DOING THOSE OTHER ACTIVITIES
TO COME UP WITH COMBINATION
THERAPIES FOR OUR PATIENTS.
AND SO THAT'S OUR GOAL AND WE
WILL IN THE PROCESS DO GREAT
BASIC SCIENCE AND HAVE NEW
NETWORKS THAT WILL BE AVAILABLE
TO ALL THE SCIENTISTS IN THE
WORLD BUT WE WANT TO COME UP
WITH NEW THERAPIES AND THAT'S
THE ANSWER.
>> GREAT.
I THINK WE HAVE TO, I THINK WE
HAVE TO KEEP IN MIND THE
CHARACTERISTICS OF THE PATIENTS
FROM WHOM THESE MODELS WERE
DERIVED.
>> TOTALLY.
>> COMPLEXITY, AND SECONDLY WE
ALSO HAVE TO CONSIDER THE
PHYSIOLOGICALITATE OF THE TUMOR,
NOT JUST THE TUMOR CELL STATES,
SO WE HAVE, I'M GOING ANDY,
AUSHI, AND THEN KAREN AND THEN I
WILL GO TO OTHER HAND FIST WE
HAVE TIME NSO JUST TO SORT OF GO
OFF OF THAT POINT, THESE ARE
SUCH VALUABLE PATIENTS FROM
PEASHT ANDS THIS IS AN
OPPORTUNITY ALSO TO BE PROFILING
PRECANCKERS OR NORMAL CONSENT
PATIENTS SO WE CAN REALLY USE
THESE AS MODELS FOR PREVENTIONS
AS WELL.
>> SO ABSOLUTELY AND THE REASON
I THINK THAT WOULD BE IMPORTANT
IN LIKE IN ANY EXPERIMENT YOU DO
IN THE LAB, IT'S THE CONTROLS
THAT ARE MORE IMPORTANT THAN THE
EXPERIMENT AND SO, WHAT YOU
WOULD LIKE TO FIND ARE MAYBE
EXTREME DEPENDENCIES THAT MIGHT
OCCUR IN A FULL CANCER AND MIGHT
BE JUST NASCENT IN THE EARLY
TUMOR AND MAYBE MISSING IN THE
NORMAL.
SO DEPENDING ON THE CANCER TYPE
WE CHOOSE, RIGHT?
WE MAY OR MAY NOT HAVE ACCESS TO
THOSE, BUT IF THERE ARE THAT
WOULD BE A GOOD SET POINT FOR
THE MODEL BUILDING EMPLOY NYEAH,
I WANT TO GIVE ALEX THE
OPPORTUNITY TO MAKE HIS COMMENT
AS WELL.
NEXT I ARKPOLOGYIZE I WILL MAKE
THIS BRIEF, QUICKLY IN RESPONSE
TO YOUR QUESTION TREY, THE REAL
GOAL IS TO UNDERSTAND HOW
MULTIPLE DEFINITE TRANSIC
FACTORS INTEGRATE TO DEFINE
STATES AND THINKING ABOUT WHERE
THE GENETIC SYSTEM IMPORTANT AND
NOT IMPORTANT IS CRITICAL AND I
CAN GIVE YOU EXAMPLES OF PDAC,
WHERE AMPLIFICATION OF A
PARTICULAR TRANSCRIPTION FACTOR
WALKS INTO A STATE AND OTHER
PLACES WHERE IT DOESN'T MATTER.
THE NICE THING IS THERE ARE BEEN
ALL THESE FUNCTION TOOLS THAT WE
BROUGHT UP THAT PUT US IN A
POSITION TO START SYSTEMATICALLY
TESTING THOSE SO NEXT TIME
YOU'RE ABLE TO TALK THROUGH THIS
BUT THINGS LIKE OVEREXPRESSION
SCREENS WHERE WOE HAVE ORGS
WHERE THEY COPY VARIANTS OR OVER
USE MY DRIVE US IN THEITATES,
REALLY COOL KREENS CAN YOU DO
THERE SAME THING WITH CRISPR
PROTEIN COMPLEX TURBATIONS AND
INTRODUCE MUTATIONS INTO MODELS
AND USE KREENING CAPABILITIES TO
SEE WHICH ARE DRIVING THESE
STATES.
AND THE WAY WE THINK ABOUT
GETTING SUPPORT FOR THIS, THE IN
SOME PLACES, THE COMBINATION
HELPS US GET A BETTER YOB CORPS
OF FIGURING OUT WHICH
COMBINATIONS TO USE SO WE HAVE
PAPER THAT WE JUST DREW ON
BIOARCHIVE THAT YOU SHOW IF YOU
COMBINE A BCR ENABLED INHIBITOR,
WITH SOMETHING TARGETING A
DISTINCT CELL PATHWAY, CAN YOU
DID A BETTER JOB OF DRIVING
REMISSION THAN USING 2 DIFFERENT
DRUGS THAT TARGET THE BCR ABLE
AND YOU KNOW THAT MIGHT SOUND
INTERESTING BUT WHAT'S REALLY
INTERESTING IS THAT THE RIGHT
COMBINATION DEPENDS UPON THE
STATE OF THE MODEL AND SO, HAPPY
TO TALK ABOUT MORE AND I WOULD
SAY PHYSIOLOGY IN THE SECOND
QUESTION WE CAME YOU UP AND
SOMETHING WE HAVE TO MODEL AS
WELL.
THERE ARE LOTS OF DARK THINGS
THAT NORMALLY WE DON'T THINK
ABOUT LIKE OXYGEN,
CONCENTRATIONS, RETENTIONS,
METABOLITES AND THE LIKE AND WE
HAVE TO DO MORE WORKING THROUGH
THIS, I WOULD SAY MANY OF YOU
ARE AWARE, INCREDIBLE ADVANCES
IN AI AND THIS GIVES US A GREAT
OPPORTUNITY NOT JUST TO ANALYZE
DATA THAT EXISTS BUT TO CREATE A
LAB IN THE LOOP ARCHITECTURE
WHERE WE CAN ACTUALLY THINK
ABOUT WHAT SPRPTS WE SHOULD DO
TO MAP OUT DIFFERENT SPACES WE
HAVE YET TO EXPLORE, SO THERE'S
A LOT WE CAN DO BUT I THINK AS
MUCH AS WE'VE DONE PROFILES IN
THE PAST, THIS IDEA OF FUNCTION,
TESTING MODELS, WHEN AND WHERE
THESE FACTORS ARE REEL KEEPSAKES
VAPT IS WHAT WE NEED FOR TRANS8
HOURSING INCREDIBLE TECHNOLOGIES
INTO INTERVENTIONS FOR PATIENTS
NTHANKS IN THE INTEREST OF TIME
WE WILL DO THESE LAST 2
QUESTIONS.
WE HAVE ASHI AND KAREN.
>> THANK YOU VERY MUCH, WE HAVE
A SAYING MOO MY LAB THAT NO
TUMOR IS AN ISLAND AND WE HAVE
WONDERFUL TECHNOLOGIES AND
DEVELOPING FOR VERY TUMOR
CENTERED.
>> CAN YOU HEAR THE MIC CLOSER.
>> SURE, REQUEST YOU HEAR ME
BETTER NOW?
NYES.
>> AND THE ORGANIZATIONSA ANOIDS
AND I LOOKEDDA THE AT THEM
THEY'RE NOT TAKING INTO ACCOUNT
THE STROMAL, THE FIBROBLAST, THE
ENDOTHELIAL, I UNDERSTAND YOU
CAN'T DO ALL OF THAT, AND I'M
JUST A LITTLE CURIOUS, BECAUSE
WE SEE EVEN WITH TARGETED
THERAPY THE HOST MATTERS, AGE
MATTERS, SEX MATTERS.
>> RIGHT, THAT WAS 1 OF THE
SLIDES I TOOK OUT FOR THE
INTEREST OF TIME.
ABSOLUTELY HAVE A SLIDE OF
SIGNALS COMING FROM THE
MICROENVIRONMENT, I THINK THAT
ALEX SHOWED YOU YOU KNOW 1
SIGNAL DGP BETA COMING FROM THE
MICROENVIRONMENT FROM THE
STROMA, THAT HE CAN MODEL AND
SEE JUST WHAT YOU'RE TALKING
ABOUT.
SO IF IT'S A CYTOKINE WE CAN ADD
IT, IF IT'S ANOTHER CELL TYPE
THERE'S LOTS OF PAPERS OUT THERE
NOW WHERE PEOPLE ARE DOING MIXED
CULTURES AND I THINK THAT'S VERY
IMPORTANT.
CAN YOU EVEN MIX IN IMMUNE
CELLS, WE WOULD HAVE TO AGAIN,
THERE'S ELABORATE PLAN THAGOREAN
WOULD HAVE TO GO INTO THIS, TO
HAVE THOSE MATCHED FROM THE SAME
PATIENT BUT IT'S DOABLE AND
WORTH DOING, OKAY?
>> OKAY, SO, WE HAVE KAREN I
WANT TO RESPECT THE VIRTUAL ROOM
AS WELL SO I WILL ALLOW SYLVIA
TO ASK HER QUESTION BUT LET'S GO
KAREN FIRST.
>> THANK YOU LOU AND ALEX SO
MUCH, VERY EXCITING INFORMATION
AND WE KNOW THAT THE TCGA FOR
EXAMPLE WAS BEHIND IN TERMS OF
DIVERSITY FROM SAMPLE FROM ANN
CESTERAL STANDPOINT, IT'S
CATCHING UP WHICH WAS GREAT, BUT
TO YOUR LAST POINT IT WOULD BE
HELPFUL TO KNOW OF THE HCMI, CAN
YOU TALK ABOUT THE ANCESTRY OF
THOSE SAMPLES BECAUSE AGAIN
ENVIRONMENT DOES MATTER, THAT
WOULD BE IMPORTANT BUT ALSO
ALEX, I WONDER IF BECAUSE THE
TCGA DOES LOOK AT METHYLATION,
DID THAT--DOES METHYLATION
STATUS IMPACT PROTURBATION AND
HAVE YOU LOOKEDDA THE DIFFERENCE
IN THAT ANCESTRY MIGHT MAKE.
>> SO, THANKS.
>> ABSOLUTELY SO WE'RE LIKE MANY
PROJECTS NOT WHERE WE NEED TO
BE.
SO WE'RE JUST A LITTLE SHY OF
10% FROM AFRICAN AMERICAN IN THE
HCMI COLLECTION, BUT WE
DELIBERATELY HAVE MADE A PUSH
WITH EXTRA FUNDING FROM THE NCI
EQUITY COMMITTEE TO MAKE NEW
MODELS THAT ARE IN DEVELOPMENT
FROM PATIENTS UNDERREPRESENTED
AND THAT IS COMPLETELY A FOCUS
OF OUR OURS, I THINK AS YOU
ALLUDE TO THERE CAN BE PROFOUND
EPIGENETIC CHAIVENLGS THAT MAY
COME FROM METHYLATION THAT MAY
AND THOSE COULD BE HIGHLY
STABLE.
IT'S AMAZING HOW STABLE
METHYLATION PATTERNS ARE IN CELL
CULTURE SO I COMPLETELY AGREE
WITH YOU AND WE WILL BE
OBVIOUSLY PROFILING THE
METHYLATION STATUS AND IT COULD
MAKE A BIG DIFFERENCE.
>> LET'S DO THIS LAST QUESTION
OR WE'RE GOING TO LOSE OUR
BREAK.
>> THANK YOU SO MUCH FOR THE
OPPORTUNITY.
I DON'T HAVE A QUESTION, JUST 2
COMMENTS.
TD 50 COMMENT IS I FIND THESE
PRESENTATIONS REALLY INSPIRING
AND I HAVE TO SAY I REALLY WANT
TO THANK THE NCI FOR
BRINGINGITOUS WHERE WE ARE TODAY
BECAUSE IT REALLY TO ME SPEAKS
TO THE CANCER SYSTEMS BIOLOGY
PROGRAM AND THE WORK THAT DI NA
SINGER AT THE NCI LEADERSHIP
CREATED 20 YEARS AGO WITH THIS
CONSORTIUM SO I FEEL LIKE THIS
IS 1 EXAMPLE OF HOW THAT WORK
HAS REALLY MATURED.
AND THE OTHER 1 IS THAT I REALLY
THINK THIS IDEA OF A FUNCTIONAL
TCGA IS FANTASTIC--BUT AS YOU
DEVELOP THE IDEA REALLY KEEP,
YOU KNOW THESE ARK I MIND SET
AND DATA SCIENCE IN MIND.
THERE'S A LOT OF, YOU KNOW SORT
OF GPT MODELS AROUND CANCER AND
BIOLOGY, SORT OF LEVERAGING, YOU
KNOW THAT EXISTING DATA THAT IS
ALREADY OUT THERE, AND LAYERING
ON TOP OF THAT, I THINK IS
IMPORTANT AS YOU BELL OUT ANY
INITIATIVATIVE AT THIS SCALE.
>> ALEX DID YOU WANT THE LAST
WORD?
>> YOU'RE ON MUTE.
MI WAS TRYING TO--I HAD BEEN
SHUT OFF BY THE ORKNIZNERS, I
100 PERCENT AGREE WE NEED TO
BETTER UNDERSTAND THE ROLE OF
DIVERSITY AND ANCESTRY AND
PUTTING THOSE THINGS FORWARD AND
I THINK EACH MORE THAN THAT WE
HAVE TO DO A BETTER YOB CORPS OF
ENABLING THE SCIENTIST TO BE
PART OF THESE CONVERSATIONS AND
THINKING ABOUT THE KINDS OF DATA
AND QUESTIONS WE SHOULD BE
ASKING, AND SO, I'M A BIG
BELIEVER THAT YES WE NEED MORE
DIVERSITY IN OUR PROFILING IN
TERMS OF SAMPLES BUT WE ALSO
MEDE DIVERSITY IN THE TERMS OF
PEOPLE THAT ARE ACTUALLY
GENERATING THE DAILY BASIS AT
WHICH THEY WILL BE CATEGORY AND
THE METHYLATION TIES TIGHTLY
INTO A LOT OF THINGS WE BEFORE
THINKING ABOUT IN TERMS OF
GENETICS, RNA THAT WE'RE TALKING
ABOUT APPROXIMATE TREY AND I
THINK ABOUT IT AS PLASTICITY AND
HOW MUCH YOU KNOW CELLS CAN
CHANGE THEIR STATES GIVEN THE
GENETICS TO RESPOND TO THERAPY
AND THAT'S WHERE METHYLATION
COMES IN.
I WILL GIVE YOU THE LAST WORD.
>> GREAT.
JUST IN RESPONSE TO SYLVIA, THE
WHOLE IDEA THAT TREY HAS
IMPLEMENTED AND OTHERS ARE
WORKING ON IS THAT THESE AI
MODELS ARE BASED ON A FRAMEWORK
OF WHAT BIOLOGY IS AND BY
CONSTRAINING AI IN THAT WAY, YOU
DON'T IMET JUST RANDOM MODELS
THAT ARE BLACK BOX, BUT YOU
UNDERSTAND WHY THE MODELS ARE
WORKING, THAT'S WHERE WE NEED TO
GO.
>> GREAT.
FANTASTIC PRESENTATION, GREAT
DISCUSSION.
THANKS LOU AND ALEX.
>> THANK YOU ALL FOR HAVING ME.
>> OKAY, GREAT, SO WE NOW HAVE A
ROUGHLY 12 MINUTE BREAK.
BE BACK AT 10:43
OKAY, NEXT ON OUR AGENDA WILL
BE A PRESENTATION ENTITLED
NETWORK CI VIRTUAL CLINICAL
TRIALS OFFICE THAT WILL BE
BROUGHT TO US BY JIM DOROSHOW,
WHO IS THE NCI DIRECTOR FOR THE
TRI VISION OF CANCER TREATMENT
AND DIAGNOSE. AND AUGUST OCHOA,
HE IS THE WITH LOUISIANA
UNIVERSITY HEALTH SCIENCES
CENTER.
SO I DIDN'T MEAN >> THANK YOU
AND THANK YOU.
I'M SO GRATEFUL THE SLIDE IS UP
SO WE CAN MOVE RIGHT ALONG, SO
THANK YOU SO MUCH FOR THE CHANCE
TO PRESENT THIS REALLY NEW PILOT
PROGRAM CALLED THE NCI'S VIRTUAL
CLINICAL TRIALS OFFICE AND MY
OUTLINE IS FIRST TO HELP YOU
UNDERSTAND THE RATIONAL WE HAD
FOR TEABING THIS PILOT PROGRAM.
I GIVE YOU AN INITIAL
DESCRIPTION, INITIAL METRICS AND
IMPORTANTLY THE LESSONS LEARNED
FROM THE FIRST 4 OR 5 MONTHS,
THIS ACTIVITY, TALK ABOUT FUTURE
PLANS AND HAVE THE PLEASURE OF
INTRODUCING DR. OCHOA, WHO
REALLY IS GOING TO TELL YOU
ABOUT THE PREPILOT, PILOT OF
THIS ACTIVITY, AT THE GULF SOUTH
NCORP IN NEW ORLEANS.
SO THIS IS A SLIDE SOME OF YOU
HAVE SEEN BEFORE BUT I WANT TO
EMPHASIZE THAT YOU ALL KNOW WHAT
HAPPENED DURING THE PANDEMIC AND
IT'S IMPORTANT TO UNDERSTAND THE
ACCRUAL BUT MAJOR ISSUES ABOUT
ACTUALLY HIRING PEOPLE TO OPEN
STUDIES, HIRING PEOPLE, KEEPING
PEOPLE,A ROUND THAT WEREN'T
BOCHED BY INDUSTRY TO ACTUALLY
DO THE WORK OF THE DATA MANAGE
AM THAT WAS REQUIRED AND IN
FACT, AS YOU WILL SEE, CONTINUE
TO THIS DAY AND IN PARTICULAR,
WE ARE FACING MAJOR PROBLEMS IN
TERMS OF HAVING THE DATA
MANAGEMENT AND CRA SUPPORT TO
ACTUALLY KEEP THE TRIALS UP TO
DATE IN TERMS OF THE ACCRUAL
DATA GETTING INTO THE
APPROPRIATE DATABASES.
THIS CONTINUES TO BE A
SIGNIFICANT PROBLEM AND SO, WHEN
WE JUST TO IMIF YOU DATA, NO
SURPRISE WHAT HAPPENED IN 2020
BUT YOU WILL SEE THE NUMBERS
HAVE NOT FULLY RECOVERED THROUGH
BACK TO 19 LEVELS AND
SPECIFICALLY, WHAT'S IMPORTANT
IS THAT WE SEE THAT--WE SEE THE
DIP BUT YOU SEE THAT THE NCTN
ACCRUAL DID COME BACK.
PHARMA ACCRUAL DID COME BACK,
ABOUT YOU WE ARE IN A
SIGNIFICANT, I THINK A
SIGNIFICANT PROBLEM IN THAT WHAT
DRIVES A LOT OF WORK THAT GOES
ON IN THE CLINICAL TRIALS AND
CORRELATIVE SCIENCE ARENAS AND
INVESTIGATOR INITIATED TRIALS.
INVESTIGATOR INITIATED ARK
CREWAL AND GRANT SUPPORT TRIALS
HAVE NOT COME BACK AND THEY ARE
20-25% BELOW WHERE THEY WERE IN
2019 AND PREVIOUS YEARS AND WE
ARE SIGNIFICANTLY CONCERNED
ABOUT THAT AND SO, THAT CONCERN
WHICH HAS PERSISTED REALLY
STARTED US THINKING ABOUT A YEAR
AND HALF AGO I AND ROUTINELY,
AFTER THAT PRESENTATION, PEOPLE
CAME OUT TO ME, WHAT CAN YOU DO,
HOW CAN YOU HELP US, REALLY OUR
CLINICAL TRIALS OFFICES ARE
TERRIBLY EXPENSIVE, WE CAN'T
HIRE PEOPLE, WE'VE RAISED THE
SALARIES, STILL IT'S DIFFICULT
FINDING PEOPLE TO GET THE WORK
DONE.
SO I TARTED THINKING ABOUT
SOMETHING TO ME TO NOT BE CLEAR
TO THOSE HERE TODAY AND THAT IS
THAT FOR MANY YEARS, PART OF THE
ACTIVITY AT THE FED RICK
NATIONAL LAB, WHICH WAS FUNDED
BY THE NIAID, WAS REALLY A
PROGRAM TO SEND CRAs AND
RESEARCH NURSES TO AFRICA TO
AROUND THE COUNTRY FOR THE--ALL
OF THE ANTIVIRAL TRIALS THAT
WERE POPPED UP AND HAD TO BE
ACTIVATED VERY QUICKLY DURING IN
2020.
AND SO, BUT THOSE ACTIVITIES FOR
THE MOST PART ARE FOCUSED ARK
ROUND AUDITING TRIALS, NOT SO
MUCH IN DOING THE WORK OF
SCREENING AND DATA MANAGEMENT
AND SO AND SO, BUT THE FACT IS
IF YOU THINK ABOUT IT, IF YOU
CAN AUDIT A TRIAL, IT MEANS HAVE
YOU ACCESS TO RECORDS, RIGHT?
YOU HAVE ACCESS TO RECORS AND
YOU CAN DO DATA MANAGEMENT.
RIGHT?
AND FIRST THING I DID ABOUT A
YEAR AND HALF OR 2 YEARS AGO WAS
TO CALL THE INDIVIDUALS WHO ARE
IN CHARGE OF THIS PROGRAM FOR
NIAID AND SAY, WELL, OKAY, YOU
MUST HAVE GOTTEN ACCESS TO THE
EHRs, CAN YOU SEND ME A LIST
OF THE INSTITUTIONS WHERE THAT
WAS ACTUALLY POSSIBLE FOR THESE
VIRALS AND THEY SENT ME A LIST
AND IT WAS A LONG LIST, A LOT OF
YOUR INSTITUTIONS WERE ON THE
LIST, A LOT OF YOUR INSTITUTIONS
WERE NOT ON THE LIST, RIGHT IN
BUT I WAS I TOOK THAT DATA AS
WELL, AS A HALF FULL PERSPECTIVE
THAT THERE ARE MANY
ORGANIZATIONS THAT WOULD ARK LOW
THE GOVERNMENT TO LOOK AT THEIR
EHR AND SO COULD WE THINK ABOUT
DOING THIS TO ASSIST THE NCI
ASSOCIATED CANCER CENTERS AND
OUR OTHER SITES THAT PLAY A
CRITICAL ROLE IN ARK CREWAL AND
ACTUALLY THINK ABOUT HIRING
PEOPLE BUT NOT JUST FOR AUDITING
BUT TO HAVE IT TO UNDERTAKE A
WHOLE PORTFOLIO OF SERVICES THAT
YOUR CLINICAL TRIALS OFFICES
PROVIDE WHETHER IT'S SCREENING,
PROMOTING ENTRY, INFORMED
CONSENT AND HEALTH, DATA
MANAGEMENT ITSELF BUT A LOT
MORE.
COORDINATEDINATEING STUDY VISITS
FOR EXAMPLE, DOING REGULATORY
REPORT, ADVERSE EEIVET
REPORTING, EVERY PLACE AND I
WILL SAY THIS TWICE, IT TURNS
OUT THAT EACH INSTITUTION THERE
ARE A MENU OF ACTIVITIES THAT
NEEDED SUPPORT BUT EACH
INSTITUTION IS DIFFERENT ABOUT
WHAT IS MOST IMPORTANT AT THEIR
INTUITION AND WHAT THEY'RE
FINDING DIFFICULTY IN DOING SO
WHAT WE DID WAS TO DO A SURVEY
OF THE CANCER CENTERS TO FIND
OUT WELL, IS THIS REALLY A
PROBLEM, DO YOU NEED HELP IN
OVERWHELMING RESPONSE,
OVERWHELMING AREY SPONSE THAT
PEOPLE NEEDED HELP.
YOU KNOW THIS IS ABOUT A YEAR
AND A HALF AGO, SO WE DID ASK,
WE QUERIED FURTHER, WELL WHAT
SPECIFIC KINDS OF HELP WOULD YOU
NEED TO ENHANCE YOUR ACCRUAL FOR
UNDERSERVED POPULATIONS, RURAL
POPULATIONS TO NCTN TRIALS.
AND WE GOT BACK AND GIVE US AN
EXAMPLE OF JUST HOW DIRE THE
CIRCUMSTANCE WAS.
I'M NOT GOING TO DIVULGE THAT
INFORMATION, BUT IT WAS
SIGNIFICANT IN TERPS OF THE
NEEDS ACROSS THE BOARD
NATIONALLY AND SO, WE BASICALLY
WENT THROUGH A PRIORITIZATION
PROCESS FOCUSING ON WHAT
INSTITUTIONS AND MADE THE BEST
CASE OR SEVERE NEED IN THE
ABILITY TO ACCRUE PATIENTS FROM
UNDERSERVED SITUATIONS CHOSE 3
NCI DESIGNATED CANCER CENTERS, 2
OF WHICH ACTUALLY HAVE MINORITY
[INDISCERNIBLE] SO FOR THE
EINSTEIN, UNIVERSITY OF TEXAS,
CHOSE 3 NCORP SITES IN RURAL
SITES THAT WERE HAVING A LOT OF
DIFFICULT GETTING THEIR DATA
MANAGEMENT DONE AND DECIDED THAT
AFTER HAVING LOOKED AT MOST
INSTITUTIONS, WHERE WAS THE
OVERLAP IN THE CLINICAL TRIALS
THAT THEY WERE ALL PERFORMING
SO WE COULD DO--DO A BETTER JOB
OF CENTRALIZING SUPPORT OF THOSE
ACTIVITIES AND FOCUS ON AN
INITIALY SET OF 12 OR 13
PROTOCOLS, AND WE'VE BEEN AT IT
FOR JUST OVER 4 MONTHS, THE
CANCERS JUST CAME ON ABOUT A
HONTH AND A HALF AGO AND I HAVE
TELL YOU I'VE BEEN OVERWHELMED
BY THE RESPONSE THAT UT UT SAN
ANTONIO, ISSUE WAS SCREENING,
THEY HAD PEOPLE TO DO DATA
MANAGEMENT, THEY DID NOT HAVE
ANYBODY TO HELP IN THE CLINIC
PROVIDING THE PHYSICIANS, SEEING
THE PATIENTS, THESE ARE THE
PROTOCOLS THAT YOUR PATIENT
MIGHT BE ELIGIBLE.
AND THEY SCREENED OVER 4000
PATIENTS IN ABOUT 4 AND HALF
MONTHS VIA THIS VIRTUAL
ACTIVITY, IDENTIFIED NOW CLOSE
TO ABOUT A HUNDRED PATIENTS,
PROTOCOL ELIGIBLE AND A FAWRTER
OF THOSE WILL BE MORE THAN IN
THE NCTN TRIALS THAT,'S JUST 3
PLACES, THE FIRST 3, AS YOU WILL
SEE IN A MINUTE, TRY TO COME TO
CONCLUSION, GET EVERYTHING SET
UP SO THAT THESE SURFACES CAN BE
PROVIDED THERE.
SO WHAT HAVEEE WE LEARNED, THIS
IS WHAT I WANTED TO SHARE WITH
YOU BECAUSE THIS A REALLY EARLY
STAGE OF THIS PILOT, BUT WE'VE
LEARNED A LOT.
SOME THINGS I HAD NO CONCEPT OF,
OKAY.
SO YES, EVERY PLACE IS DIFFERENT
IN TERMS OF MOUs SET UP, EVERY
PLACE IS A LITTLE BIT DIFFERENT
IN TERPS OF IT AND THEIR IT
SECURITY SO YOU HAVE TO LEARN
WHAT THE PRINCIPLE QUESTIONS
ARE, FOR THESE PLACES, I THINK
THE MORE WE DO THIS, THE MORE WE
LEARN WITH THE ENTIRE MENU OF
ISSUES ARE RELATED TO IT
SECURITY AND WE HAVE TO FOR ALL
OF THE PEOPLE THAT ARE GOING TO
PARTICIPATE, THEY HAVE TO GET
THE APPROPRIATE ASHES COUNTS IN
THE CTSU TO BE ABLE TO, THE
ORGANIZATION, OUR ORGANIZATION,
NCI FREDERICK, THE VIRTUAL, THE
STAFF, AND ALSO ALL OF THE FOLKS
ACTUALLY AT INDIVIDUAL SITES CAN
COLLABORATE WITH RESPECT TO THE
PARTICULAR TRIAL ANDS THE
PARTICULAR ACCRUAL.
I THINK PROBABLY THE BIGGEST
LESSON LEARNED AND I DON'T WANT
TO PICK ON EPIC PER SE, IT'S
JUST THE FIRST 6 SITES THAT WERE
CHOSEN ARE ALL EPIC SITES IS
THAT THIS IS A BIG DEAL, IN
GETTING ACCRUAL AND GETTING
ACCESS, AND AGAIN, WHAT I WANTED
TO SAY IS BASICALLY WHAT I
LEARNED THAT I WAS COMPLETELY
IGNORANT OF, RIGHT?
SO I WOULD GUESS THAT MOST OF
YOU WORK AT MAJOR ACADEMIC
MEDICAL CENTERS AND IF I WERE TO
PUT IT TO YOU AND YOU HAD TO
RAISE YOUR HAND, DO YOU THINK IT
WILL BE EASIER TO GET ACCESS TO
THE EHRs AT THE COMMUNITY
SITES OR ACADEMIC MEDICAL
CENTERS AND I'M WILLING TO BET
THE VAST MAJORITY OF YOU WOULD
SAY ACADEMIC MEDICAL CENTERS,
AND THAT'S WRONG.
OKAY.
THE ACADEMIC MEDICAL CENTERS
ACTUALLY OWN THEIR INSTANCE OF
EPIC, AND SO, SO THAT HAS NOT,
IT'S NOT THAT IT TAKES A SHORT
PERIOD OF TIME, BUT IF THE
UNIVERSITY OF KANSAS DECIDES
THAT IT WANTS TO PARTICIPATE IN
THIS ACTIVITY, THEN THERE CANCER
CENTER DIRECTOR CAN GO TO THE IT
SECURITY FOLKS AND IT HAPPENS,
RIGHT?
THE PROBLEM AND SOMETHING I HAD
NO CONCEPT OF, IS THAT AT
MANY--EASY TO DEAL WITH, VERY
SMALL PRACTICES THAT OWN SMALL
EHR SYSTEMS, RIGHT?
BECAUSE THEY OWN IT, IT'S FOR
THEIR BILLING, THEY WANT
ASSISTANCE, NO PROBLEM, BUT
INTERMEDIATE, HOSPITAL SYSTEMS
DON'T NECESSARILY BUY A FULL
INITANCE OF EPIC OR
[INDISCERNIBLE], IN ESSENCE THEY
LEASE FROM AN INTERMEDIARY
PROVIDER, THESE ACCESS TO THESE
MAJOR SYSTEMS AND SO, THE SITE
MAY BE 100% GUNG-HO TO
PARTICIPATE, EPIC SAYS, NOT OUR
PROBLEM, RIGHT?
, INTERMEDIARY THOUGH, WE HAVE
TO DEAL WITH THEIR LAWYERS AND
THE IT SECURITY ISSUES, AND
THEY'RE REALLY NOT FOCUSED ON A
FACILITATING CLINICAL RESEARCH.
THAT'S WHERE OUR BIGGEST PROBLEM
HAS BEEN.
THAT'S WHAT I'VE LEARNED IN THE
LAST 4 MONTHS.
SO THIS IS REALLY A ROAD, WE'VE
LEARNED A LOT ABOUT HOW TO
ENGAGE THE SITES, I THINK THAT'S
BASICALLY WE PUT TOGETHER
MATERIALS, PROBABLY TO HELP
INDIVIDUAL SITES AND THEIR
CLINICAL TRIALS OFFICES LEARN
WHAT WE NEED, WE NEED TO HAVE A
MUCH BETTER UNDERSTANDING OF
WHAT THE LEGAL PREPARATION NEEDS
TO BE TO BE ABLE TO DO THIS.
IT REALLY IS VERY SAFE, YOU CAN
GIVE A SINGLE PATIENT ACCESS,
ONLY FOR THE PATIENTS ON THE
TRIALS, SO THAT THERE'S REALLY
VERY LITTLE CHANCE OF DATA
SECURITY BEING BREECHED BUT
EXECUTING THE MEMORANDUM OF
UNDERSTANDING, SECURE THE THIRD
PARTY AGREEMENTS, IS TIME
CONSUMING BUT I THINK WILL
SHORTEN, AS WE'VE GOTTEN MORE
EXPERIENCE, AND THEN, YOU KNOW
WE HAVE TO AND WE'VE LEARNED
THAT WE NEED TO PROVIDE ONGOING
SUPPORT FOR THE QUESTIONS AS
THEY ARISE TO HELP INDIVIDUAL
SITES, MOVE THIS FORWARD.
SO LET ME JUST END BY TALKING
ABOUT FUTURE PLANS, SO I SAID AS
YOU SAW WE HAD 6 INITIAL SITES,
THOSE ARE SINGLE SITES, SO OUR
PUSH RIGHT NOW IS OF COURSE
EVERY 1 OF THESE MAJOR CANCER
CENTERS AND EVEN THE OTHER
SITES, THE CLINICS, HAVE
MULTIPLE OTHER SITES, AFFILIATE
SITES AND SO WE'RE TRYING TO
EXPAND TO AS MANY OF THE
AFFILIATE SITES AS POSSIBLE FOR
INITIAL 6, WE HAVE 3 MORE, LEAD
ACADEMIC NIH INSTITUTIONS BODY
NCORP AND NCI CENTERS THAT WE
HOPE TO BRING ON THIS THE NEAR
FUTURE, NOT READY TO SAY WHOSE
THOSE FOLKS ARE BUT ULTIMATELY
WE HOPE TO HAVE 30, 35 LEAD AND
AFFILIATE SITES PARTICIPATING
FOR THE NEXT YEAR TO 2 YEARS,
AND THEN REALLY UNDERSTAND THE
NUMBER OF TRIALS WE'RE
SUPPORTING TO A MUCH LARGER
ISSUES 20-30 TRIAL ANDS REALLY
UNDERSTAND WHAT ARE THE ISSUES,
HOW HARD IS THIS, HOW BIG OF A
BENEFIT IS THIS TO INDIVIDUALS,
AND IS THIS REALLY A SERVICE
THAT WILL ALLOW US, YOU KNOW
WHAT WE LEARN, HOW TO DO THIS,
HOW WE EASILY IMAGINE PROVIDING
ASSISTANCE OF CANCER CENTERS
THAT ARE ABOVE OR BEHIND THE
ACQUISITION, THIS CUSTOMER MIGHT
ALLOW US TO PROVIDE SERVICES IN
RURAL SITES AND MANY OTHER
PLACES THAT ARE NOT CURRENTLY,
THEY JUST DON'T HAVE THE
INFRASTRUCTURE BUT IF WE CAN
PROVIDE IT FOR THEM WHICH IS I
CAN TELL YOU FOR SURE, THIS CAN
BE DONE, IT IS BEING DONE, AND
REALLY IF WE HAD THE RESOURCES
WILL ALLOW US TO GREATLY EXPAND
THE NUMBER OF SITES THAT ARE
AVAILABLE WHERE THESE TRIALS CAN
BE UNDERTAKEN.
THE LAST THING I WANT TO SAY IS
IN CONVERSATION WITH THE SITES
THAT ARE ACTIVELY PARTICIPATING
IS THAT 1 OF THE THINGS ADDITION
TO THAT, LIST OF SERVICES IS
THAT THEY'RE ALSO VERY
INTERESTED IN WHETHER OR NOT WE
CAN PROVIDE ACCESS AND DATA FOR
LONG-TERM FOLLOW UP WHICH I HAVE
TO ADMIT TO YOU IS SOMETHING
THAT WE PAID VERY POORLY FOR,
RIGHT IN AND SO BUT IS
ABSOLUTELY NECESSARY AND SO
WE'RE TRYING TO CONSIDER THAT.
SO LET ME JUST GO ON TO
INTRODUCING DR. AUGUST O OCHOA
WHO WILL GIVE YOU HIS HANDS ON
EXPERIENCE WITH HIS INITIAL
APPROACH TO DOING THIS.
>> THANK YOU I DIDN'T MEAN AND
THANK YOU VERY MUCH FOR HAVING
ME HERE TODAY WITH YOU, LET MEEE
IF I DID THE WRONG THING, RIGHT
THING IN OKAY, SO AS JIM WAS
TALKING ABOUT THE NASCENT IDEA
FOR THE VIRTUAL CLINICAL TRIALS
OFFICE CAME FROM WHEN WE STARTED
OUR SECOND PHASE OF OUR NCORP
INTO 2016, 2017 AND AS YOU CAN
SEE THE NCORP HAS MADE A
TREMENDOUS DIFFERENCE IN OUR
CORNER OF THE UNITED STATES
WHERE CLINICAL TRIALS WAS
VIRTUALLY MINIMAL PARTICIPATION
PRIOR TO 2010.
IT IS WELL IMON TO THIS AUDIENCE
THAT THAT THE EPICENTER OF THE
CANCER EPIDEMIC IS IN GREAT PART
IN THE GULF PART SOUTH STATES,
LOUISIANA, MISSISSIPPI, ALABAMA
AND ARKANSAS.
AND SO ABOUT 12-15 YEARS AGO WE
STARTED TRYING TO BELL A
COALITION OF THE BIGGEST AND
MOST IMPORTANT HOSPITAL SYSTEMS
IN THE STATE OF LOUISIANA AND
ALMOST ALL OF THE ACADEMIC
SCANSER CENTERS FORM WHAT WE NOW
CALL THE GULF SOUTH CLINICAL
TRIALS NETWORK THAT IS FUNDED
NOW BY THE NCORP.
THIS HAS MADE--RESULTED IN US
HAVING 49 DIFFERENT CLINICAL
SITES THROUGH THE REGION, MOST
OF THEM IN THE STATE OF
LOUISIANA, BUT NOW SOME IN
MISSISSIPPI AND NOW ACTUALLY IN
ALABAMA.
SO WE PROVIDE ACCESS TO CLINICAL
TRIALS THROUGH ALL OF THESE
SITES.
AND WHAT THIS RESULTED IN IS A
DRAMATIC IPT GREATER CREASE IN
THE NUMBER OF PATIENTS
PARTICIPATING IN CLINICAL
TRIALS.
IN 2009 IT WAS SOMEWHERE BETWEEN
A HUNDRED TO 150, ALTOGETHER
THROUGHOUT THE SAIT OF
LOUISIANA, TODAY WE CURRENTLY
ENROLL IN THE LAST 6 YEARS
SOMEWHERE BETWEEN 1200 TO 1500
PATIENTS ON CLINICAL STUDIES
THROUGHOUT THE WHOLE STATE.
AND MORE IMPORTANTLY, AS YOU CAN
SEE IN THAT WHYELLO LINE, THE
PARTICIPATION OF MINORITY
PATIENTS IS EVEN MORE
SIGNIFICANT, IT HAS DOUBLE
FRIDAY ABOUT 25-30% NOW, TO
ROUTINELY ENROLLING IN 55-60% OF
OUR PATIENTS REPRESENTING
MINORITIES MOSTLY AFRICAN
AMERICANS.
BUT NOT EVERYTHING IS HAPPY.
IN LOUISIANA AS WE ALWAYS THINK
OF ALL THE GOOD THINGS WE DO
BUT, BECAUSE ALTHOUGH OUR MAJOR
CLINICAL CENTERS ESPECIALLY IN
THE ACADEMEC SITES AND THE
CITIES IN LARGER HECK OF A TIME
FOR IN MEET NOTHING 2017, WE
ASKED THE PHYSICIANS AND WE
ASKED THE PROBLEM WE'RE GIVING
YOU EVERYTHING WE THOUGHT YOU
NEEDED AND THE ANSWER WAS WE
WOULD LOVE TO PARTICIPATE, AND
THEY SAID WE DON'T HAVE THE
CANNOT AFFORD A RESEARCH NURSE,
WE CANNOT AFFORD A DATA MANAGER
AND MUCH LESS GO THROUGH THE
REGULATORY PROCESSES AND THE
PATIENT SAID WE WOULD LOVE TO
PARTICIPATE BUT WE'RE NOT GOING
TO TRAVEL TO NEW ORLEANS WHICH
IS 75 OR 80-MILES AWAY OR TO ANY
OF THE OTHER CITIES LET US DO IT
CLOSER TO HOME.
CAN WE THOUGHT AT THAT MOMENT
THIS IS ESSENTIAL BECAUSE IN
LOUISIANA AS IN THE REST OF THE
COUNTRY, THE MAIORITY OF
PATIENTS ARE TREATED IN
COMMUNITY CANCER CENTERS, NOT IN
OUR IN, CI DESIGNATED OR IN
LARGE ACADEMIC TRUSTEESS, SO
THIS HAD TO BE ADDRESSED EMPLOY
SO BACK AT THAT TIME, EILEEN
[INDISCERNIBLE] WAS SITTING HERE
WITH ME AND I STARTED THINKING
WHAT CAN WE DO TO BRING NOT
TELEHEALTH WHICH TRADITIONALLY
BRINGS THE DOCTOR, BUT THROUGH
VIRTUAL MEANS BRING THE RESEARCH
SUPPORT TO THESE SITES AND WE
STARTED USING WHAT WAS THEN VERY
MYSTERIOUS COMMUNICATION SYSTEMS
THAT WE NOW KNOW HAVE CHANGED
COMPLETELY SINCE COVID BUT AT
THAT TIME WE SAID, LET'S TRY TO
SEE IF WE CAN SCREEN THE CLINICS
OF THE DOCTORS AHEAD OF TIME, SO
WE GOT PERMISSION TO ACCESS
THE ELECTRONIC MEDICAL RECORDS,
OUR VIRTUAL RESEARCH NURSE
LOCATED IN NEW ORLEANS WOULD
SCREEN THE CLIN INCREASE IN
BODYS OF THE DOCTORS AHEAD OF
TIME, WOULD IEE, AUDIENCE
DENTIFY PATIENTS THAT ARE
POTENTIALLY ELIGIBLE FOR
CLINICAL TRIALS, WOULD DISCUSS
THOSE PEASHTS WITH THE DOCTOR,
THE WEEK BEFORE AND THEN THE
DOCTOR WOULD INTRODUCE THE IDEA
OF PARTICIPATING A CLINICAL
TRIAL TO THE PEASHT WHEN THE
PATIENT ARRIVED IN THE CLINIC,
IF THE PATIENT SAID YES, THEN
THEY WOULD CLICK THE COMPUTER
ON, THE VIRTUAL RESEARCH NURSE
WOULD COME ON AND IN SOME CASES
WE ACTUALLY HAD A LITTLE LAPTOP
IN NOSE PLACES THAT THE VIRTUAL
RESEARCH NURSE WAS THERE ALL THE
TIME AND SO THEN THE VIRTUAL
RESEARCH NURSE WOULD DO THE
CONSENTING, COMPLETE ALL THE
PAPERWORK NEEDED FOR ENROLLMENT
OF THE PATIENTS, SET THE
CALENDERS FOR ALL THE ACTIVITY
ANDS THEN CONTINUE THE FOLLOW
UP.
WE TESTED THIS INITIALLY IN 2
VERY DIFFERENT SITES, 1 WAS A
SMALL RURAL HOSPITAL WITH A
HUNDRED AND SOMETHING ANALYTIC
CASES WITH A PART-TIME
ONCOLOGIST WHO SAID THEY WANTED
TO TEST THIS WITH 1 TRIAL.
THE OTHER 1 WAS A SMALL ACADEMIC
GU PRACTICE THAT WAS AT A
SUBURBAN HOSPITAL, NOT
ASSOCIATED DIRECTLY WITH THE
CANCER TRUSTEES.
AND WHAT WE FOUND OUT WAS 2
THINGS, NUMBER 1 WE BEING SCREEN
THE PATIENTS AHEAD OF TIME SO AS
YOU CAN SEE IN BOTH SITES WE
SCREENED ACTIVELY BUT THE ONLY
ENROLLMENTS HAPPENED IN THE SITE
WHERE NUMBER 1 THERE WAS A
CRITICAL NUMBER OF CLINICAL
TRIALS OPEN AND NUMBER 2 WHERE
THERE WERE FULL-TIME PHYSICIANS
THAT WERE REALLY COMMITTED TO
THIS PROCESS, SO AT THAT TIME, 2
THINGS HAPPENED, NUMBER 1 WE
CAME TO TALK TO THE NCI, AND WE
TALKED TO WHARTA Mc KASP A R
KILL STEPHENS AT THAT TIMES ARE
AND WAS ENTHUSIASTIC BUT SAID
SHOW ME CAN YOU DO THIS IN MORE
THAN A COUPLE PLACES THAN YOU'VE
DONE.
AND THE SECOND 1 WE TALKED TO
JIM DOROSHOW, AND SAID THE SAME
THING, THE NEXT THING THAT
HAPPENED WAS COVID AND WHEN
COVID HIT, 2 THINGS WERE VERY
IMPORTANT, NUMBER 1 ALL OF THESE
RULINNATED ANTIGENSS AND
REGULATIONS WE HAD ABOUT VIRTUAL
COMMUNICATIONS WERE NOW AT THE
DOOR, EVERYBODY STARTED
COMMUNICATING, EVERYBODY STARTED
SHARING INFORMATION, AND SO WE
DID THE SAME.
SO WE CONTINUED WITH OUR
ONCOLOGY, OUR GU ONCOLOGY GROUP.
WE OPENED UP ANOTHER RURAL SITE,
AT GULF PORT MEMORIAL HOSPITAL
IN GULF PORT MISSISSIPPI AND
RECENTLY OPENED A SECOND
SUBURBAN HOSPITAL SITE AND AS
YOU CAN SEE HERE OF ALL THE
PATIENTS, WE WERE ABLE CLEARLY
TO PRESCREEN THE PATIENTS,
IDENTIFY THOSE AND IN THE SITES
WHERE IT BECAME A ROUTINE TO
HAVE PATIENTS ENROLL IN CLINICAL
TRIALS, LIKE THE GU SITE, THE
FIRST 1 YOU SEE UP THERE,
SCWEAT% OF OUR PATIENTS WENT ON
CLINICAL TRIALS, THE INTERESTING
PART IS THAT THE OTHER SUBURBAN
HOSPITAL IS ALSO RAPIDLY RAMPING
UP AND THE RURAL HOSPITAL HAS
BEEN SLOWLY GETTING THERE AND
I'LL TELL YOU A LITTLE BIT MORE
ABOUT WHY WE THINK THAT IT IS
NOT AS RAPID AS WHAT WE WOULD
LIKE BUT THE OTHER THING THAT'S
IMPORTANT IS THAT IT REALLY ARK
TRACTED THE ATTENTION OF THE
PHYSICIANS AT THOSE SITES WHO
RAPIDLY INCREASED THE NUMBER OF
CLINICAL TRIALS THAT THEY WANTED
TO OPEN.
SO IN SUMMARY OVER THE SEVERAL
YEARS THAT WE TESTED THIS, WE
PREKREENED ABOUT 2300 PATIENTS,
WE ENROLLED ABOUT 140, THE VRN
CAN KREEN AND ENROLL PATIENTS,
IT HAS ESTABLISHED INTEREST ON
THE CLINICIANS FOR PARTICIPATING
THIS AND HAS HELPED US BUILD
TRUST WITH THESE RURAL SITES AND
THESE COMMUNITY CLINICS.
THEY ALSO ATTRACTED THE
ATTENTION OF THE FEDERAL
GOVERNMENT, DR. BIDEN CAME TO
VISIT US AND SEE HOW THIS
WORKED.
WE ACTUALLY, YOU CAN SEE THE
SCREEN OF THE TV WE'RE CONNECK
WIDE THE GULF PORT SITE AND IF
YOU LOOK AT THE RATE SITE HERE,
CAN YOU SEE DR. DOROSHOW, HIDING
THERE BEHIND SOMEBODY ELSE.
SO LESSONED LEARNED FROM WHAT WE
CALL THE VIRTUAL RESEARCH NURSE,
IT CAN SUPPORT CLINICAL TRIALS,
BUT, AS DR. DOROSHOW SAID, EACH
SITE IS DIFFERENT, YOU HAVE TO
WORK VERY CLOSELY WITH EACH SITE
OUR VIRTUAL RESEARCH NURSE NEEDS
WEEKLY WITH OUR PHYSICIANS AT
THE DIFFERENT SITES AND WE MEET
WITH THEM IN PERSON QUARTERLY TO
REVIEW CLINICAL TRIALS,
ACCRUALS, WHICH TRIALS NEED TO
BE CLOSE, WHICH TRIALS NEED TO
BE OPEN.
WE ALSO NEED TO GET DATA SO WE
CAN REAMLY REFINE THIS PROCESS,
SO WE'RE IN THE PROCESS OF
COLLECTING DATA THROUGH DATA
PLAN, RESEARCH LOGS ISSUES
PATIENT ENGAGEMENT SURVEYS AND
STRUCTURED INTERVIEWS THAT ARE
BEING LED BY DENISE
[INDISCERNIBLE], 1 OF OUR PUBLIC
HEALTH STATISTICIANS.
BUT I THINK 1 OF THE LESSONS
THAT I LEARNED VERY QUICKLY WAS
THAT THE MOST IMPORTANT HELP WE
RECEIVED WAS FROM BEING PART OF
THE NCORP.
ALL OUR SITES ARE PART OF THE
NCORP AND SO GETTING USER
AGREEMENTS AND BUSINESS
ASSOCIATE AGREEMENTS SO THAT WE
CAN ACTUALLY ACCESS ELECTRONIC
MEDICAL RECORS WAS TREMENDOUSLY
MUCH EASIER THAN IF WE WERE
WORKING WITH UNAFFILIATED SITES.
OUR NEXT STEP IS TO CONTINUE THE
COLLECTION OF DATA, THE SECOND
PART WAS AS I PROMISED
DR. DOROSHOW BACK THEN THAT WE
WOULD WRITE SOPs SO THAT
ANYBODY COULD TAKE THIS
SOPUNISHINGs AND IMPLEMENT
THEM AT THEIR SITES ACCORDING TO
THEIR NEEDS BUT I THINK MORE
IMPORTANTLY IS WHAT JIM IS
ALOUDING TO, TRYING TO PROVIDE
MUCHERS--DENISE DENNIS WAS 1 OF
OUR OTHER COLLABORATORS AT THESE
COMMUNITY HOSPITALS THAT HAVE
PARTICIPATED WITH US FINALLY
THIS WAS FUNDED BY PILOT GRANT
FROM THE NCORP PROGRAM AND FROM
THE ALL CORP LAND FOUNDATION CHO
IS OUR LOCAL SUPPORTER SO THANK
YOU AND WE WILL TAKE SOME
QUESTIONS.
>> WE HAVE A LOT OF HANDS.
TART HERE.
>> THANK YOU.
THAT WAS A TBRAIT PRESENTATION
AND I WOULD LOVE THE PRACTICAL
APPLICATION OF, YOU KNOW YOUR
VISION TO HEAR IT, I WAS
WONDERING 2 THINGS, 1, HOW ARE
YOU SELECTING THE SITES TO
PARTICIPATE, I IMAGINE THERE
WOULD BE INTEREST AND YOU'RE
LOOKING FOR, YOU KNOW KIND OF
REPRESENTATION, SO, JUST CURIOUS
HOW COULD A SITE GET INVOLVED OR
ARE YOU AT THIS POINT ARE YOU
HAND [INDISCERNIBLE]
>> SO BASICALLY THIS START WIDE
A BIG SURVEY OF ALL THE CANCER
CENTERS AND CORE SITE ANDS THEY
HAD TO FILL OUT AND PROVIETD US
DATA WITH, I MEAN, IT'S
BASICALLY RESILIENCE PORT CARD.
HOW FAR ARE YOU BEHIND IN YOUR
DATA MANAGE AM.
WHAT IS YOUR PERCENT OF RURAL OR
PATIENT POPULATION, HOW MANY
PROTOCOLS DO YOU HAVE OPEN, ARE
YOU--DO YOU THINK THAT YOUR IT
SYSTEMS AND SECURITY ANALYSTS
WILL ACTUALLY ARK LOW US TO
PARTICIPATE AND WE PLAYED A HUGE
GRID AND PRIORITIZED BASED ON
EXACTLY THE NEED AND IN
PARTICULAR, THE NEED IN THE
CONTEXT OF TRYING TO FOCUS ON
RURAL AND UNDERSERVED
POPULATIONS NAND YOUR 3 NEW
CERNER SITES ARE ALONG THAT.
>> EXACTLY.
>> DR. OCHOA, TALKING ABOUT
UNDERRESOURCING OF RURAL
COMMUNITIES, ET CETERA, I'M
WONDERING IF YOU CONSIDERED
DEVELOPING COMMUNITY HEALTHCARE
WORKFORCE THAT SUPPORTS, YOU
KNOW ADDRESSES CULTURAL LANGUAGE
ANDET ESTROGEN, THOSE NEEDS BUT
CAN KEEP THE LINKAGE BETWEEN THE
COMMUNITY HOSPITAL, THE VIRTUAL,
ET CETERA, ET CETERA AND AT THE
SAME TIME PUT UNDER--I THINK
UNDER EMPLOYEES TO WORK AND GIVE
THEM SOME WORK IN THOSE
COMMUNITIES BECAUSE THEY CAN
BECOME THE GLUE AND THE BRIDGE
TO ALL OF THIS WORK.
>> AND THANK YOU FOR THAT
QUESTION BECAUSE CLEARLY IT'S
VERY TIMELY.
WE HAVE JUST STARTED
CONVERSATIONS WITH OUR COMMUNITY
OUTREACH PROGRAMS THAT ACTUALLY
RUN THE KREENING, THE EARLY
DETECTION PROGRAMS FOR BREAST,
CERVICAL AND COLORECTAL AND
SEVERAL OTHER PARTS THROUGHOUT
THE STATE WITH THE IDEA OF
FINDING WAYS TO LINK WHAT WE DO
WITH OUR VIRTUAL PROGRAM AND
WHAT THEY'RE DOING SO THAT WE
CAN TURN OUR COMMUNITY EDUCATORS
INTO FACILITATOR OF THIS
PROCESS.
>> NEALY?
>> THANK YOU SO MUCH FOR
TACKLING THIS BIG CHALLENGE IN
SUCH CREATIVE WAYS.
A COUPLE COMMENTS.
ONE IS THAT DO HAVE YOU ANY
COMPONENTS OF EDUCATION FOR THE
PATIENTS BECAUSE WE FOUND IN A
SURVEY IN THE MOUNTAIN WEST THAT
88% OF THE PEOPLE WHO LIVE
THERE, WHO SURVEY DID NOT KNOW
ABOUT CLINICAL TRIALS AND COMING
IN WITHOUT KNOWING ABOUT IT,
MAKES THAT CONVERSATION WITH THE
CLINICIAN LESS PRODUCTIVE AND
THE SECOND PART IS A CALL UPON
COLLABORATING WITH YOUR NEW
SENIOR DIRECTOR FOR DATA SCIENCE
BECAUSE WE WILL NEVER BE ABLE TO
FUND FOR EVERY CENTER A VIRTUAL
NURSE BUT WHAT ABOUT USING LARGE
LANGUAGE MODELS, TRYING TO HELP
TO DO SOME OF THAT PREPARATION,
EDUCATION BEFORE PATIENTS COME
IN.
>> SO I THINK THE LATTER IS
GOING TO BE VERY IMPORTANT BUT
NOT SO SIMPLE, RIGHT?
BECAUSE IT TIES TOGETHER WITH
THE NEEDS TO--LET'S WRUOF THE BE
HONEST.
WE WOULD ALL LOVE TO HAVE MOST
OF THIS INFORMATION AT LEAST THE
DATA MANAGEMENT ISSUE AND THE
ELEMENTS WE COLLECT BE DONE IN
AN AUTOMATED FASHION, RIGHT?
AND THAT WOULD BE--THAT WOULD BE
OUR GOAL AND IT'S NOT SO SIMPLE
AND IT'S NOT GOING TO HAPPEN
TOMORROW, RIGHT?
BUT THAT'S WHERE WHERE I THINK
THE KIND OF LARGE LANGUAGE
ACTIVITIES MIGHT BE MOST HELPFUL
EMPLOY WE STILL ARE--THERE ARE
MANY OTHER THINGS ON THAT LIST,
ON THAT PORTFOLIO OF SERVICES
THAT ARE NOT SO--WOULD JUST BE
TAKEN UP BY AN AI MODEL.
IN ESSENCE WE WANT A LARGE SCALE
HELP DESK AND THIS IS REALLY
CRITICAL FOR SMALL SITES TO BE
ABLE TO HAVE ESSENTIALLY AT
LEAST 8 HOURS A DAY, THERE'S
SOMEONE TO CALL WHO'S
KNOWLEDGEABLE, WE DON'T
UNDERSTAND, WHAT DOES THIS
PROTOCOL REALLY MEAN, WHAT DO
YOU HAVE TO COLLECT, HOW DO
YOU--CAN YOU HELP US WITH OUR
LOCAL CONSENT ISSUES, OR OTHER
ISSUES, AND SO WITH THAT, YOU
REALLY DO NEED, I THINK AT LEAST
FOR THE TIME BEING, YOU NEED
PEOPLE, RIGHT, TO BE ABLE TO DO
THAT AND YOU ANSWER IT, YOUR
FIRST QUESTION WAS.
>> EDUCATION.
>> SO BASICALLY 1 OF THE MAJOR
COMPONENTS OF THIS ACTIVITY IS
TO DEVELOP AN EDUCATIONAL
MATERIALS SO ON THAT KIND OF--I
WENT THROUGH IT VERY FAST, THE
WINDY ROAD OF WHERE WE ARE,
THERE'S A WHOLE PIECE TO EDUCATE
THE SITE, BOTH FOR PATIENTS AND
FOR THE NURSES AND THE PROVIDERS
TO REALLY, WHAT IS THAT ALL
ABOUT, YOU KNOW, BECAUSE SOMEONE
MIGHT BE CONCERNED THEY SHOW UP
ON A SCREEN FOR SOMEONE WHO'S
OVERHERE, WHO KNOWS WHERE,
LOOKING AT THEIR DATA AND
TALKING TO THEM ABOUT THIS WHOLE
PROCESS, SO YES, THERE'S AN
EDUCATIONAL PIECE THAT'S BUILT
IN.
>> SO WE HAVE HOWARD AND RAY AND
ABDOMEN RIA, CHRIS, WELL THE'S
TART WITH HOWARD.
>> NTHANK YOU.
I WAS REALLY IMPRESSED WITH JIM,
YOU'RE TALKING THIS ON AND DOING
THIS, SO ACCRUAL IS A GREAT END
POINT, AND I MIGHT HAVE MISSED
IT BUT DID YOU TALK ABOUT
ANYTHING FOR ADHERENCE AND
INTENTION AND COMPLETERS, I WAS
INTRIGUED BY AN ASH PRESENTATION
FROM GRADY HOSPITAL IN ATLANTA
THAT ABOUT A YEAR AND A HALF AGO
THAT PARTNERED WITH CVS PHARMACY
ARE LOOKING AT MYELOMA
PRESCRINGZS AND WHAT THEY SHOWED
THAT THE OUTCOMES, HEALTH
OUTCOMES OF THE PATIENTS WERE
REALLY LINKED TO THE, YOU KNOW
THE DATA THAT THEY HAD ABOUT
RETENTION THAT CVS HELPED THEM,
SOPHISTICATED IT WAS NOT EPIC,
IT WAS CVS, IT WAS THE FIRST
TIME I SAW CVS AT A NATIONAL
CONFERENCE, ABOUT YOU IT SHOWS
THE PHARMACY GROUPS MIGHT BE
INTERESTED IN FURTHER PARTNERING
ABOUT THIS KIND OF WORK NI THINK
THAT'S PART OF THAT I WILL TAKE
OIT'S OBVIOUS THAT IF WE'RE
ACTUALLY DOING THE DATA MANAGE
AM THEN THE AUDITING GOES HAND
IN HAND.
SO WE'LL HAVE ADHERENCE DATA
BECAUSE WE WILL--WE ARE ACTUALLY
HELPING WITH THE MOVEMENT OF THE
INFORMATION FROM THE EHR
INTORAPHY AND SO IT'S ALMOST AS
IF WE'RE DOING A REALTIME
AUDITING FUNCTION BECAUSE WE'RE
PROVIDING THAT SERVICE HANDS ON.
>> YEAH, JUST A GREAT
PRESENTATION, LOVE IT.
TWO OBSERVATIONS AND MAYBE A
QUESTION.
THE FIRST SUBDIVISION IS EXACTLY
RIGHT.
THE VAST MAJORITY OF CANCER CARE
DELIVERY IS IN HIEWNT HEALTHCARE
SYSTEMS AND IF WE WANT TO YOU
KNOW CONVERT THEM FROM DESERTS
TO TROPICAL LIMATES WE HAVE TO
ENGAME THEM DIRECTLY AND DO
EXACTLY WHAT YOU DID WHICH IS
LEARN FROM THEM WHAT IS YOUR
EXPERIENCE, DON'T
[INDISCERNIBLE] IN YOUR IVORY
TOWER, GO TO THE PLACE WHERE THE
WORK IS BEING DONE, TRY TO
FIGURE OUT HOW CAN MAKE THIS FIT
THIS IN THIS IS IMPORTANT
ENOUGH.
THE OTHER OBSERVATION IS EXACTLY
WHAT YOU POINTED OUT, THE MAIP
BARRIERS ARE NOT PATIENT LEVEL,
WE ALL KNOW THIS, IT'S
INSTITUTIONAL AND PROVIEDMAN US,
RIGHT?
AND WE'RE GOING TO SOLVE THIS
PROBLEM, WE'RE GOING TO HAVE TO
ENGAGE THE INNS TUITIONS AND THE
PROVIDERS, IN THE PLACES WHERE
THE PATIENTS GO.
THE QUESTION I HAVE IS THERE'S
THIS ECHO MODEL THAT HAS BEEN
VERY SUCCESSFUL IN MANY OTHER
REALMS, THIS SEEMS LIKE A
WONDERFUL OPPORTUNITY TO USE THE
ECHO MODEL TO DO SOMETHING
BENEFICIAL.
ANY IDEAS ABOUT HOW 1 COULD USE
THE ECHO MODEL IN THIS ENDEAVOR?
>> SO GOOD QUESTION.
WE LOOKED AT THE ECHO MODEL
EARLY ON WITH THE IDEA THAT WE
BEING USE A SIMILAR APPROACH BUT
I THINK THAT YOU MADE A VERY
IMPORTANT POINT IN YOUR FIRST
STATEMENT AND THAT IS THAT EACH
SITE, YOU HAVE TO GAIN THEIR
TRUST, IT'S NOT THAT YOU BRING
THEIR, THE BIG MODEL, THE BIG
OVERWHELMING MODEL THAT'S GOING
TO WORK HERE, YOU HAVE TO WORK
WITH THEM, TALK WITH THEM, GIVE
THEM A SENSE OF CONTROL AND
INPUT, THEY ARE GOING TO TELL US
WHAT IS IMPORTANT AND WHY
THEY'RE FALLING BEHIND.
THE ACADEMIC PARTNER COMOONT
COME IN A PATERNALISTIC APPROACH
AND SO WITH THE ECHO MODEL,
ALTHOUGH WE HAD SEVERAL MEETINGS
AND APPROACHES AND THOUGHT OF
HOW TO IMPLEMENT IT, WE WERE
UNABLE TO GET TRACTION ON THAT.
THIS INSTEAD BECAUSE WE WERE
BRINGING THEIR NURSES, WE WERE
BRINGING THEIR PHYSICIANS, WE
WERE GOING THERE AND
PARTICIPATING AND DISCUSSING
WITH THEM, THAT CREATED THE
EMPATHY AND THE DISCUSSION
PROCESS THAT ALLOWED THEM TO
ACTUALLY HELP US TELL THEM, TELL
US WHAT WE NEEDED TO BUILD AND
SO THAT'S HOW WE'VE SLOWLY BUILD
THEM AND THAT'S WHY IT'S TAKEN A
FEW YEARS TO GET WHERE WE ARE.
>> THANK YOU, ANDREA.
NTHAIRNG YOU AGAIN, THIS IS
OUTSTANDING WORK.
AS FAR AS THE TRUST YOU JUST
STARTED TO TALK ABOUT AND
TRUFFING IN THE COMMUNITY, WHEN
WE ENROLL PATIENTS IN CLINICAL
TRIES WE ARE LIKELY TO INN ROLL
IF THE PERSON PROVIEDMANNING THE
INFORMATION LOOKS LIKE THEM OR
IS OF A SIMILAR ETHNIC GROUP AND
I DIDN'T SEE THE EXACT
PERCENTAGES OF ENROLLEE IN BLACK
VERSUS WHITE PATIENTS BUT IS
THERE AN OPPORTUNITY WITH YOUR
VIRTUAL WERE NURSES TO INCREASE
THE NUMBER OF ETHNICALLY DIVERSE
RESEARCH NURSES IN ORDER TO
INCREASE THEIR WORK ON THE
TRIALS.
I SUSPECT THERE'S ONLY A FEW,
BUT THERE MAY BE ONLY 1 OR 2 BUT
IT SEEMS TO ME IF WE WOULD USE
THIS OPPORTUNITY TO INCREASE THE
NUMBER OF DIVERSE PRN THEN
ENROLLMENT ON THESE CLINICAL
TRIALS WOULD INCREASE.
>> VERY IMPORTANT POINT.
SO 2 THINGS, WE HAVE WORK WITH
OUR SITES RATHER THAN GO TO 2
SITES AND WORK FOR THEM IS
BECAUSE THEY HAVE CREATED THAT
EMPATHY IN THE COMMUNITY.
THEY RELATE TO THE COMMUNITY,
THEY REPRESENT IN THE COMMUNITY,
THEY LIVE IN THE COMMUNITY AND
SO WE'RE NOT BRINGING THE
DOCTORS OR NURSES.
THE NURSES ARE ONLY PROVIDING A
SUPPORT STRATEGIES AND THEY'RE
PROVYING THE VR NS AND YOU
SHOULD EVERYBODY SHOULD LEARN TO
BE A VRN IN OUR TEAM AND THAT'S
WHAT THE PLAN IS.
NOW WE'RE TARTING WITH A FEW
THAT WE TRAIN SO THEY CAN THEN
TRAIN THE OTHERS NTHANKS IN THE
INTEREST OF TIME WE WILL DO 2
MORE BUT PLEASE BE SUCCINCT AND
FOCUS ON YOUR QUESTIONS.
LET'S GO DR. LOPEZ AND NEWMAN.
>> THANK YOU.
THANK FOR AN EXCELLENT
PRESENTATION AND EXCELLENT WORK,
WHAT I WONDERED IS YOU MENTIONED
SOPs EMPLOY SO DISSEMINATION
IS CRITICAL.
AND WE'VE ALL SEEN THAT DESPITE
THE TREMENDOUS PROGRESS THAT WE
MADE WITH TELEMEDICINE, IT'S ALL
GOING BACKWARDS, AND ARE YOU
FINDING SIMILAR RESISTANCE TO
USING THESE VIRTUAL SYSTEMS FOR
CLINICAL TRIALS NI DON'T THINK
IT'S AS MUCH RESISTANCE, IT'S
ABOUT EICATION AND EDUCATION
WITH THE PATIENTS BUT ALSO
EDUCATION WITH THE COMMUNITY
PHYSICIANS BECAUSE THE GREAT
MAIORITY OF OUR ONCOLOGISTS ARE
NOT TRAINED IN RESEARCH
INTENSIVE CENTERS SO REMEMBER 10
YEARS AGO, CLINICAL TRIALS WERE
SORT OF THE LAST DITCH EFFORT
FOR A PATIENT, THAT WAS THE
COMMON, TODAY IT'S NOT.
TODAY SHOULD BE PART OF THE
PLANNING OF A REGULAR TREATMENT
ON A PATIENT.
AND SO, IF THE DOCTORS IN THE
COMMUNITY HAVE BEEN TRAINED MORE
THAN 10, 20 YEARS AGO, THEY
DON'T HAVE THAT EXPERTISE, THEY
DON'T HAVE THAT EXPERIENCE, SO
WHEN WE HAVE TO WORK WITH THEM
AND THAT'S HOW WE WORK FOR
EXAMPLE, WITH THE GULF PORT
TEAM.
THEY HAVE LEARNED AND NOW ARE
RAPIDLY OPENING UP NEW TRIALS SO
IT'S A PROCESS OF TRAINING AND
EDUCATION.
>> SO LISA AND I WILL ALLOW THE
1 FINAL QUESTION FROM
DR. [INDISCERNIBLE].
HE HAD HIS HAND UP, BUT I WILL
ALLOW LISA PLEASE BE SUSSIRNGHT.
>> IFY QUESTION WAS ADVERSITY SO
THANK IF YOU ARE THAT, JUST 1
LOGISTICS QUESTION, YOU KNOW
WE'RE ALSO CONSTRAINED IN TERMS
OF PACE AND TIME IN CLINIC WITH
REGARD TO INTRODUCING THE
PATIENTS FROM VIRTUAL NURSE
MODEL IS WONDERFUL, HOW MUCH
FLEXIBILITY DO THOSE VIRTUAL
NURSES HAVE IN TERMS OF THOSE
INTERACS OCCURRING AT THE PATES
WITH THE CELL PHONE?
>> WHATEVER WORKS.
THE MODEL IS WHATEVER WORKS.
>> SO, PART THAT ALLOWS US TO
CONTINUE THE FOLLOW UP THE
PATIENTS IS THAT THEY CAN
COMMUNICATE WITH A RESEARCH
NURSE.
NOW THE INTAKE IS IN THE
DOCTOR'S OFFICE ISSUES THE
INITIAL PROCESS, BUT THE FOLLOW
UP CAN BE DONE IN OUR VIRTUAL
RESEARCH NURSE FOLLOWS THOSE
PATIENTS.
YES OF COURSE.
>> FINAL QUESTION.
IN, YES, IMETTING CARE CLOSE TO
HOME, IMPROVES PATIENT
SATISFACTION, SO IT'S ASHES
MAZING THAT OUT OF THE 2400
PATIENTS, 1400 WERE FROM THE
ORIGINAL LOCATION, SO THAT
ALREADY IS A SUCCESS.
>> THANKS, WONDERFUL
PRESENTATION AND DISCUSSION.
THANK YOU.
SO THE BOARD WILL NOW CONSIDER
ONGOING AND NEW BUSINESS, FIRST
WE WILL CONSIDER THE REPORTS
FROM THE 3 SUBMITEES THAT MET
LAST EVENING.
THE SUBMITEE CHAIRS WILL GIVE
THE REPORTS, THE FIRST
SUBCOMMITTEE REPORT WILL BE
GIIVE BY DR. NEIL AZAD, CHAIR
FOR THE SUBCOMMITTEE ON CLINICAL
INVESTIGATORS, MILO.
>> GOOD MORNING EVERYBODY IT WAS
A REAL PLEASURE TO BE ABLE TO
CHAIR THE SUBCOMMITTEE MEETING
YESTERDAY EVENING WHICH IS A
PERFECT SEGUE FROM WHAT WE'VE
BEEN TALKING ABOUT THIS MORNING
WHICH IS ABOUT HOW WE CAN DO
PRAGMATIC TRIALS THAT CAN ALLOW
US TO INCREASE THE KIND OF
ENROLLMENT THAT WE GET AND THAT
REALLY ARK LOW US TO REPRESENT
THE TRUE POPULATION IN THE
UNITED STATES AND SO, WE
DEDICATED THIS MING LAST NIGHT
TO THE LUNG CANCER PRAGMATIC
TRIAL WHICH IS DIFFICULT TO
DRIEB IN ANY OTHER TERMS AS AN
UNQUALIFIED SUCCESS FOR THE
CLINICAL INVESTIGATIONS GROUPS
WITHIN THE NCI, AND SO,
DR. MARGARET MOONY WHO IS THE
ASSOCIATE DIRECTOR OF CTEP AND
THE DIVISION OF CANCER TREATMENT
AND DIAGNOSIS, CAME AND
PRESENTED AND AN UPDATE AN
INTERIM ANALYSIS OF THE SUCCESS
SO FAR OF THE LUNG CANCER
PRAGMATIC TRIAL AND SO, YOU KNOW
AS PRELIMINARY DATA FOR WHY THIS
TRIAL ACTUALLY MOVED FORWARD,
DR. MOONY PRESENTED THE RESULTS
OF THE SURVEY THAT WAS
ADMINISTERED TO THE NATIONAL
CLIN KACCTICAL TRIAL IT IS WORK
SOCIETY ABOUT 2IERS AGO IN 2022,
AND WHAT THAT SURVEY HAD SHOWN
WHICH WE TALKED ABOUT IN A
PREVIOUS SUBCOMMITTEE MEETING IS
THAT THERE WAS GENERAL
SATISFACTION WITH MANY CAN
COMPONENTS OF THE NCTN AND
IMPROVEMENTS HAD BEEN MADE OVER
THE LAST FRIEW YEARS BUT THERE
CONTINUE TO BE HIGH LEVELS OF
DISSEFGZ FOR A COUPLE KEY AREAS
AND THAT INCLUDED THE ENROLLMENT
OF DIVERSE POPULATIONS WHICH WAS
STILL FELT TO BE A WEAKNESS, AND
THE EFFICIENT ACTIVATION AND
COMPLETION OF CLINICAL TROOLS SO
TIMELINES, AND THEN OF COURSE,
THERE FTION SIGNIFICANT
CHALLENGES AROUND FUNDING AND
THE AMOUNT OF PER PATIENT
FUNDING THAT THE NCTN GETS FOR
EACH ENROLLMENT SO WHAT COULD WE
DO TO INCREASE THEENTIOUS
FICIENCY OF THOSE FUNDS.
SO THE LUNG CANCER PRAGMATIC
TRIAL WAS DESEENED TO REALLY RYE
TO FOCUS ON SOME OF THESE KEY
BARRIERS, IT WAS DESIGNED IN
COLLABORATION WITH INDUSTRY,
WHICH IS AN IMPORTANT COMPONENT
OF THIS, SO, BOTH ELI ILLUMINATE
EXPE MARK WERE INVOLVED
IMPORTANTLY IN THIS DESIGN, AND
IT WAS DESIGNED TO ANSWER
QUESTIONS THAT--A QUESTION THAT
WAS IMPORTANT TO THE RESEARCH
COMMUNITY AND TO THE CLINICAL
TREATMENT COMMUNITY AND SO, IT
REALLY WAS FOCUSED ON AN AREA
THAT INDUSTRY MIGHT NOT TAKE ON
THEMSELVES, BUT IS STILL AN
IMPORTANT QUESTION WHEN IT COMES
TO TREATING PEASHTS AND SO THIS
TRIAL LOOKED AT PATIENTS THAT
HAD ALREADY HAD FIRST LINE
THERAPY FOR METASTATIC DISEASE
AND LUNG CANCER AND PATIENTS
WERE RANDOMIZED TRIAL OPEN
MEETINGIZED IN A VERY PRAGMATIC
WAY IN A STANDARD OF CARE IN A
SECOND LINE, FOR PROVIDER CHOICE
ACROSS GUIDE LINES ACROSS THE
EXPERIMENTAL GROUP OF
[INDISCERNIBLE] AND
[INDISCERNIBLE] PARTICULAR
COMPANIES INVOLVED AND BASED ON
STRONG PRELIMINARY DATA FROM A
RANDOMIZED PHASE 2 STUDY THAT
SHOWED A TREND TOWARDS
IMPROVEMENT IN SURVIVAL BUT WHAT
WAS KEY WAS REALLY A SIMPLIFIED
DESIGN OF THE TRIAL AND A
SIMPLIFIED CONSENTS PROCESS AND
SO EARLIER TODAY, WE TALKED
ABOUT THE CONSENT FORM FOR THAT
TRIAL SO THAT WAS ONLY 11 PAGES,
SO DR. REDFIELD REMEANEDDED ME
IT WAS ONLY 7 PAGES IF YOU TOOK
OUT THE 4 PAGES REQUIRED OF IT
SO IT WAS A SHORTENED CONSENT,
IT HAD REDUCED DATA COLLECTION
EVEN IMPANELING AT ANY TIME HAVE
TO BE PUT INTO THE DATABASES,
SINCE OVERALL SURVIVAL WAS THE
END POINT.
THE RISK PROFILE OF THIS--THESE
DRUGS WERE WELL KNOWN AND SO THE
IF, DA ALSO ALLOWED FOR REALLY
VERY LIMITED TOXICITY COLLECTION
AROUND SEVERE TOXICITY SO IT
MADE IT EASIER FOR SITES TO BE
ABLE TO ENROLL.
THE TIMELINE FROM WHEN THE
PROPOSAL WAS FITTER SENT TO THE
STEERING COMMITTEE TO ACTIVATION
WAS 200 DAYS, DR. MOONY PUT THAT
IN A STARK CONTRAST TO THE
AVERAGE PHASE 3 TIMELINE OF 540
DAYS, SO REALLY DOING FAR BETTER
THAN EVEN OTHER INDUSTRY
SPONSORED STUDIES AND THERE WERE
IN ADVANCE CONCENTRATED EFFORTS
TO IMPLEMENT RECRUITMENT
STRATEGY AND THOSE MATERIALS
WERE DEVELOPED CONCURRENTLY FOR
WHEN THE STAT WAS BEING
ACTIVATED AND SO, THAT WAS AIAN
PARTICULARLY HELPFUL IN TERMS OF
BEING ABLE TO ENROLL THE
CLINICAL TRIAL, SO WHEN THE
TRIAL WAS DESEENED IT WAS
DESIGNED AS A TRIAL OF 700
PATIENTS, IT WOULD EXPECTED IT
WOULD TAKE 24 MONTHS TO INN ROLL
THAT STUDY AND WHEN DR. MOONY
PRESENTED THE DATA YESTERDAY, IT
WAS 15 MONTHS INTO THE TRIAL,
72% OF THAT GOAL HAS ALREADY
BEEN ACCRUED MUCH THE SAMPLE
SIZE IS LIKELY TO BE INCREASED
TO 800 PATIENTS WHEN HAVE WE
HEARD OF SOMETHING LIKE THAT
HAPPENING WHICH WILL ALLOW FOR
GREATER POWER, WHEN IT QUMS TO
BEING ABLE TO LOOK AT THE DAILY
BASIS AT AND SUBSET ANALYSIS OF
PATIENTSAs WELL, AND EACH WITH
TAKEN--THEY INCREASE IN SAMPLE
SIZE, THE ESTIMATES ARE THAT THE
STUDY WILL COMPLETE WITHIN THE 2
YEAR TIMELINE.
IN PARTICULAR, WHAT WAS VERY
COMPELLING TO ALL OF US
YESTERDAY WAS THE GROUP WHERE
THE PATIENTS WERE ENROLLED IN
THE STUDY THUS FAR, AND SO
COMPARING TO THE SEER DATABASE,
IT INCLUDED PATIENTS THAT WERE
AFRICAN AMERICAN, IT INCLUDED
PATIENTS WITH SIMILAR NUMBERS OF
LATINO PATIENT ANDS IT REALLY
SHOWED THAT WHEN YOU DO THESE
SIMPLIFIED TRIALS THAT WE REALLY
CAN ENHANCE THE DIVERSITY OF THE
KINDS OF PATIENTS ENROLLED AND
ALSO A VERY NICE ANALYSIS OF
RURAL VERSUS URBAN POPULATIONS
AND WE ALSO ARE ENROLLING
PATIENTS THAT ARE BUILDING ON OR
EQUAL TO WHAT'S IN THE SEER
DATABASE FOR RURAL POPULATIONS
WHICH IS AN IMPORTANT POPULATION
GROUP TO THINK ABOUT AS WELL.
AND SO DR. MOONY PRESENTED THIS
EXCITING DATA, WE THEN MOVED
INTO THE DISCUSSION PORTION
WHERE WE REALLY TARTED TALKING
ABOUT WHAT'S NEXT, NOW, SO WE
HAVE THIS REALLY SUCCESSFUL
MODEL, WHAT'S COMING NEXT, THERE
IS ALREADY A PLAN TRIAL IN THE
ADJUVANT LONG SETTING THAT
DR. MOONY DISCUSSED, THERE'S
ALSO A CLINICAL TRIALS
INVESTIGATION UNIT THAT STARTED
THIS YEAR, AND REALLY TAKEN ON
THE TASK OF TRYING TO FIGURE OUT
WHAT THE NEXT STEP SHOULD BE,
THERE WAS A CONSENSUS THAT WE
REALLY WANT TO FOCUS ON THINGS
THAT ARE EXCITING WHERE THE
SCIENTIFIC QUESTIONS AND
CLINICAL QUESTIONS ARE IMPORTANT
BUT WHERE WE CAN STILL ALSO
BUILD ON THE KIND OF DIVERSITY
WE HAVE IN THE STUDIES, WE ALSO
TALKED A LITTLE BIT ABOUT SOME
OF THE CHALLENGES OF PRAGMATIC
STUDY WHICH IS THAT YOU LOSE
DATA AND SO THERE WAS SOME
CONVERSATION ABOUT LOSING THE
OPPORTUNITY WHEN WE ARE
ENROLLING SUCH A DIVERSE
POPULATION TO MAYBE NOT GET THE
BIOSPECIMENS, WE'RE NOT GETTING
SOME OF THE QUALITY OF LIFE DATA
THAT WILL NICE TO HAVE A AND A
BALANCING ACT BETWEEN THAT, AND
WE TALKED ABOUT HOW WE CAN
CONTINUE TO COME UP WITH NEW
TREATMENT OPTIONS THAT WOE CAN
TEST, WE TALKED ABOUT THE IDEA
OF INVOLVING THE STEERING
COMMITTEE LEADERSHIP WHICH MIGHT
BE PARTICULARLY WELL SUITED TO
KNOW WHAT THE IMPORTANT
QUESTIONS ARE, AND OVERALL I
THINK WOE LEFT THAT MEETING VERY
HEARTENED BY THIS PARTICULAR
TRIAL AND WHAT IT REALLY MEANS
FOR THE FUTURE OF NCTN STUDIES
AND DOING PRAGMATIC TRIALS.
NFANTASTIC AND COMPELLING.
QUESTIONS?
>> SO I DIDN'T GET MY QUESTION
BEFORE BUT IT'S PERFECT NOW, SO
I'M REFLECTING ON WHAT KIM
ASKED US FOR AT THE END OF HER
TALK IS HOW DO WE ACCELERATE THE
PROGRESS AND DORPHY AND GET
PATIENTS ON STUDIES AND GET
DISCOVERIES OUT TO THE COMMUNITY
AND I'M REFLECTING ON OUR PRIOR
PRESENTATION AND THE
CONVERSATION LAST NIGHT WITH
PRAGMATICCA AND I THINK THAT'S
THE ROADMAP OF LIMITED
PARTNERSHIPPING FROM INDIVIDUAL
STUDIES THAT DO THIS WELL AND
WHAT ARE THE COMPONENTS OF THAT
WORK, GREETS THAT WORK IN THE
COMPELLING DATA PRESENTED BY
BOTH OUR LAST PRESENTERS,
PARTICULARLY DR. OCHOA'S
EVALUATION OF WHAT HE'S DOING
AND THAT'S ESSENTIAL AS WE MOVE
FORWARD.
SO, I DON'T KNOW IF THERE'S BEEN
A DEEP DIVE INTO PRAGMATIC LUNG
MOTTIC WE HEARD A DISCUSSION, I
DON'T KNOW IF THERE'S ACTUALLY
BEEN ANY EVALUATION BUT IF A
SECOND TRIAL IS SORT OF BEING
LAUNCHED IN THIS EFFORT,
EMBEDDING THAT PROJECT WITH
ACCRUAL THINGS TO STUDY, THAT
PROVIDES YOU WITH THE ROADMAP.
>> I AGREE, THE DIAMONDS ARE IN
THE DETAIL.
>> WAS THERE ANYTHING
IDENTIFIED, YOU MENTIONED THE
SHORT CONSENT FORM, NOT HAVING
TO REPORT, A LOT OF THE CATA.
WAS THERE ANY DATA ON THAT DATA
FOR WHAT CONTRIBUTED TO THE
INCREASED ACCRUAL, WAS THAT IT
OR MORE PEOPLE DOING MINORITY
CONSENTS OR WHAT IS KRIEWBING TO
THAT?
SO WE DIDN'T HEAR ANY OF THOSE
CATABECAUSE I DON'T WANT TO SAY
IT'S NOT BEING LOOKED AT AND
MAYBE DR. DOROSHOW MIGHT BE ABLE
TO ANSWER THAT QUESTION BUT THAT
WOULD BA I GREAT FOLLOW ON TO
THIS, SO TO ACTUALLY SURVEY THE
SEATS AND LOOK AND SEE WHICH OF
THESE THINGS ACTUALLY MADE MUCH
EASIER FOR YOU TO ENROLL IN THIS
TRIAL, BECAUSE, THERE WERE MANY
CHANGES THAT WERE MADE BASED ON
PREVIOUS, YOU KNOW PREVIOUS
FAILURES, BUT PREVIOUS
CHALLENGES, AND SO WHICH OF
THOSE WAS THE MOST USEFUL TO
THEM, TO WHAT THE DOCTOR WAS
SAYING.
>> SO WE HAVE ROY AND SUSAN AND
CHECK.
>> SO I CAN TELL YOU AS A RULING
TO THIS, 1 WORD SIMPLICITY.
THAT'S ALL IT IS.
AND SOMETIMES WE GET, 1 WAY JUST
OUT OF LONG STANDING PRACTICE,
SO WHEN PRAGMAT
CERTAINLY--CERTAINLIA LONG
STARTED AS PEOPLE STARTED
ENROLLING EVEN I AS A CLINICIAN,
THE SIMPLICITY OF THE WAS ALMOST
MIND BOGGLES AND WE WOULD GO
BACK AND SAY WELL, SURELY WE
HAVE TO DO CAT SCANS, NO, SCAN
SCATS BUT, BUT, THE FDA SAID
IT'S OKAY, IT'S OKAY, WE HAVE TO
TALK OURSELVES DOWN.
SO GOING TO THE NEXT STEP, THE
CTIU DID THIS PROPOSAL CALLED
FOR PROPOSALS, THERE IS A TRIAL
LONG PROSPECT LONG IS THE NAME
OF THE TRIAL AND ONCE IMEAN I
THINK WE ARE TRYING TO GET IN
OUR OWN WAY OUT OF OLD HEALTH
BENEFITS AND ACTUARIALETS.
O FOR EXAMPLE, PROSPECT LONG AND
SAD, THIS IS A VERY IMPORTANT
QUESTION WHEN PROPOSAL WAS MADE,
IT WAS--IT WAS DEEMED THAT VERY
INNOVATIVE TO TRY TO DO QUOTE
ENROLLMENTS ACROSS MULTIPLE
STUDIES TWHA WERE IN THE SAME
SPACE, BUT SUDDENLY WE GET THE
PUSH BACK FROM NETWORK CI, AND
CTEP, SAYING WELL, WE DON'T KNOW
IF THE AT THAT TIMES WILL WORK
OUT THIS WAY OR THE OTHER.
REMEMBER, REMEMBER, THIS IS
SUPPOSED TO BE PRAGMATIC, WE
NEED THE PATIENT IN THERE, LET'S
LEVERAGE--ANYWAY, I DON'T WANT
THIS TO BE A IMRIEP SESSION, I
THINK SOMETIMES, WE'RE SO DEEPLY
EMBEDDED IN THE OLD WAY OF DO
THINGS THAT WE CAN'T GET OUT OF
OUR WAY.
NYES NNETWORK KRRK I DIRECTORS
PREROGATIVE >> YEAH, IN JUST
WANT TO MAKE--YEAH JUST WANT TO
MAKERS AND A COMMENT TO THAT,
LET YOU KNOW THAT YOU KNOW THE
CTIU IS A YEAR OLD SO WE DECIDED
TO HAVE A RETREAT AND SEE WHAT'S
WORKING, WHAT'S NOT WORKING AND
WHAT DO WE NEED TO DO SO WE CAN
DO MORE.
AND I THINK BY THE WAY FDASCENT,
IT WAS A FAB FANTASTIC DAY AND
KIND OF THE BIG TAKE HOME IS
PROBABLY THAT WE'VE JUST DOWN 1
TRIAL AND SO WE NEED TO
PRACTICALIS, WE MEDE TO SEE
WHICH THINGS TO MAKE THESE KINDS
OF INNOVATIONS AND CHANGES IN
PRACTICE BECOME MORE, WE JUST
HAVE TO DO MORE.
SO THAT'S COMING.
>> SUSAN.
>> YEAH, PIGGYBACKING ON SOME
OF THE EARLIER COMMENTS I ALSO
WONDER IF THIS IS AN OPPORTUNITY
TO PARTNER WITH THE EXCEPTIONAL
IMP LEMMATION SCIENCE
COLLEAGUES, THAT ARE HERE AT
NETWORK CI OR EXTERNALLY, TO
ALMOST DO LIKE A CORRELATIVE
STUDY OR A PARALLEL STUDY OF
WHAT WORKS AND REALLY SPEAKING
ABOUT THAT, YOU KNOW AS YOU'RE
ROLLING OUT LIKE THE NEW 3 SITES
THAT DR. DOROSHOW WAS TALKING
ABOUT, OR THE NEXT BIG TRIAL
RATHER THAN WONDERING ABOUT IT
AFTER THE FACT, HOW DO WE
INCORPORATE THAT AND I THINK
HAVE YOU THE EXPERTISE IN THIS
ROOM.
NCHUCK NI WILL KEEP THIS BRIEF
SINCE THIS PILOT, TO STERILIZED,
IT SOUNDS STERILIZED,
SIMPLIFIED, TREME LINED SO PART
OF OUR CHALLENGE WILL BE HOW DO
WE BUILD ON THIS PLATFORM AS WE
ADD COMPLEXITY.
NOT ALL TRIALS WILL LOOK LIKE
THIS.
HOW DO WE LEARN FROM THIS AND
LAYER UPON IT OTHER THINGS AND
SIMPLIFY THOSE OTHER THINGS, THE
IMANNUALING, DATA, AND HOW DO WE
DO THIS SOMATICALLY IN A PLANNED
WAY IT WOULD HELP US GET THAT.
>> I HAVE QUESTIONS BEFORE
MOVING ON, KAREN AND ANDY.
>> I WANT TO ALSO 1 OF THE
THINGS THAT STRUCK ME IS WILL
FACT THAT DR. MOONY TALKED ABOUT
THEY EDITED THE ELIGIBLE, THAT
HAS A HUGE REPERCUSSION FOR
ENABLING INCLUSIVE, AND THEY
ENCLOUD THINGS LIKE A BAMERICA I
OF LESS THAN 25, THAT'S NOT
GOING TO HAPPEN IN THE U.S.,
RIGHT IN SO PART OF WHAT WE NEED
TO DO THAT'S THE PRACTICAL THING
SO I LOVE THE FACT THAT YOU'RE
TALKING ABOUT INN CLUING THE
IMPLEMENTATION SCIENCE GROUP TO
SAY, WHAT ARE THE THINGS THAT WE
CAN AVOID, LIKE THAT WE CAN
REALLY TAKE OUT, THAT DON'T
IMPACT, YOU KNOW THE OUTCOMES OF
STUDIES AND I THINK THAT IS A
REALLY IMPORTANT THING TO JUST
MENTION.
>> GREAT, LAST QUESTION.
NI GUESS REALLY WANTED TO SORT
OF HIGHLIGHT THE CHALLENGE YOU
BROUGHT OUT ABOUT BALANCING A
COMPLEXITY AND PRAGMATIC STYLE
WHEN IT COMES TO THINGS LIKE
BIOSPECIMENS AND
BIOREPOSITORIES, BECAUSE WE NEED
TO THINK ABOUT VALUE WITH THESE
AND HOW THEY CAN CONTRIBUTE TO
SCIENCE.
SO IN JUST SOME OF THE
QUALITATIVE WORK I'VE HEARD, I
THINK THIS' AN ASUMP THAT
BIOSPECIMENS CLICKING THOSE
SPECIMENS IS A BIRRIER
SURFACESSIER, WE SHOULD
CHALLENGE THAT.
WHETHER THAT'S REALLY TRUE AND
IT DO SOME OF THE WORK THAT
PEOPLE PROPOSED HERE, DO
CORRELATIVE STUDIES TO
UNDERSTAND THE BARRIERS TO
THOSE, SO WE CAN DIVERSIFY
BIOBANDS AND MAKE THEM ABLE TO
PERFORM THE SCIENCE AND PLAN
BETTER TRIALS IN THE FUTURE.
NOKAY, THANKS, THANKS ANDY.
SO GREAT PRESENTATION, MILO, SO
THE NCAB MEMBERS WILL NEED TO
VOTE TO ACCEPT THE REPORT, IS
THERE A MOTION IN.
>> MOTION.
>> SECOND.
>> MOVED AND SECOND.
>> ANY FURTHER DISCUSSION?
IF THERE IS NONE, WE SHOULD VOTE
ARE THERE ANY NAYS?
ABSTENTIONS?
UNANIMOUS.
SO MOVING ON TO THE NEXT
SUBCOMMITTEE REPORT, ON THE AD
HOC SUBCOMMITTEE ON POPULATION
SCIENCE EPIDEMIOLOGY AND
DISPARITIES WILL BE PROVIDED BY
DR. WINKFIELD.
>> THANK YOU SO MUCH JOHN AND
THANK YOU SO MUCH FOR EVERYBODY
WHO PARTICIPATED LAST NIGHT.
WE HAD A FULL HOUSE WHICH WAS
FANTASTIC, THERE WERE FOLKS
THERE THAT WERE NOT SUBCOMMITTEE
MEMBERS SO I WANT TO THANK YOU
ALL FOR PARTICIPATE NOTHING
PERSON, IT'S IMPORTANT TO HAVE
YOUR VOICE AND IT'S INVALUABLE
AND 1 OF THE THINGS THAT I FIRST
DID WAS TO REMIND FOLKS OF WHAT
THE SUBCOMMITTEE IS ABOUT,
BECAUSE I THINK TIMES THAT CAN
GET LOST, WE OFTEN TIMES WILL
TALK ABOUT SUBCOMMITTEES BUT THE
CHARGE OF THIS PARTICULAR
SUBCOMMITTEE IS REALLY TO ADVISE
ON SOME OF THE STRAY JECTORY
TEENINGIC APPROACHES AND
OPPORTUNITIES TO ENHANCE
NCIEYE'S CONTRIBUTION TO
POPULATION SCIENCE, EPIDEM
IMROLG AND DIVERSITY, SO THE
SUBNITRIC OXIDEEE IS RESPONSIBLE
FOR IESHES DENTIFYING
OPPORTUNITIES TO ADDRESS
POPULATIONS FACING DISPARITIES
THROUGH MULTIDISCIPLINARY
PROGRAM ANDS RESEARCH
SURVEILLANCE, PATIENT CARE,
PRIMARY PRERENGZ, EDUCATION AND
CANCER CONTROL.
SO IT'S A WIDE SWATH OF THINGS
THAT REALLY JUST A SUBCOMMITTEE
IS REASONABLY RESPONSIBLE FOR
REALLY HELPING TO ADVISE ON AND
PART OF THE STRAY JECTORY EDGY
WAS TO SAY, WELL WHAT IS NETWORK
KRRK I ALREADY DOING IN SOME OF
THESE SPACES SO IN THE LAST
MEETING WE ACTUALLY HAD SOMEONE
COME, DR. GOD ARD COME AND TALK
ABOUT SOCIAL DETERMINANTS OF
HEALTH AND NIH WIDE INITIATIVE
TO HELP DEFINE WHAT THE SOCIAL
DETERMINANTS OF HEALTH ARE AND
WHERE THE METRICS WE NEED TO BE
INCLUDING IN SOME OF THE
RESEARCH AND SO THIS TIME WE
WANTED TO GIVE AN OPPORTUNITY TO
TALK ABOUT SOME OTHER THINGS
THAT HAVE BEEN HIGH PRIORITY IPT
GREATER CLUING MSET TESTING O
MCDs, THEE MULTICANCKER
DETECTION TESTS, AND WE HAD A
DOCTOR WHO WAS THE DIRECTOR OF
CANCER PREVENTION COME AND GIVE
A PRESENTATION, GIVE AACR AND I
THOUGHT IT WAS REALLY IMPORTANT
FOR THIS GROUP TO ACTUALLY HEAR
AGAIN AND REALLY TO TALK ABOUT
HOW THE IN, CI'S INTERESTED IN
EVALUATING SOME OF THESE NOVEL
BLOOD BASED MULTICANCKER
DETECTION TESTS AND HE STARTED
OUT BY SAYING THIS IS A HUGE
OCEAN AND WE'RE NOT CLEAR WHICH
1 OF THESE MCDs WILL BE
PROMISING.
WILL THEY HAVE THE IMPACT THAT
WE THINK THEY WILL HAVE AND SO
IT WAS REALLY IMPORTANT FOR HIS
GROUP TO REALLY TART TO SAY, HOW
DO THESE TESTS ACTUALLY PROVIDE
ANY CLINICAL BENEFIT, HOW CAN
HE--THE NCI BE AN HONEST BROKER
IF YOU WILL, OF DIFFERENTIATING
BETWEEN SOME OF THESE TESTS, AND
REALLY SAYS THAT IT WAS
IMPORTANT AND I THINK THIS WAS A
KEY MESSAGE THAT THESE NSAID ARE
ARE PART OF A CONTINUUM OF CARE,
ANYTIME WE THINK ABOUT SCREENING
FOR CANCER IT'S JUST 1
COMPONENT.
IF YOU SCREEN AND DON'T DO
ANYTHING WITH RESPECT TO
DIAGNOSTICS, WHAT ARE WE DOING?
IF WE SCREEN PEOPLE AND THEN
DON'T HAVE A WAY FOR THEM TO GET
THE TREATMENT THEY NEED, WE'RE
WHAT ARE WE DOING?
WE CAN EXACERBATE SOME OF THE
DISPARITIES AND SO YOU ALREADY
HEARD DR. RATHMILL TALK ABOUT
THE VANGUARD STUDY BREAFLY AND
DR. CASSELL SPLEANED MORE ABOUT
VAN GUARD BUT HE FIRST PREFACED
IT BY TALKING ABOUT SHIP, THE
OTHER STUDY THAT THEY TALKED
ABOUT AND THAT'S THE 1 WHERE HIS
GROUP IS LOOKING AT CIRCLE
CANCER KREENING AND HOW CAN WE
ACTUALLY ALLOW AND EMPOWER,
INDIVIDUALS AND PATIENTS TO
ACTUALLY SELF-SCREEN, RIGHT, HOW
DO WE DOP THAT AND AGAIN THAT'S
JUST A KREENING COMPONENT AND 1
OF THE LESSONS LEARNED AGAIN IS
THAT SCREENING IS JUST 1 PART,
WHAT HAPPEN FIST THERE'S A
POSITIVE FINDING, DO WOE HAVE
THE TIEWPT TO CONNECK PEOPLE
WITH THE SERVICES THEY NEED FROM
A DIAGNOVARTIS NUMBER OF THETIC
AND ALSO A TREATMENT STANDPOINT
BUT I THINK THAT SHIP TRIAL IS 1
OF THE THINGS WE REALLY NEED TO
KEEP AN EYE ON BECAUSE IT WILL
REALLY EMON SPHRAIT SOME OF THE
GAPS IN TERMS OF THE CARE THAT
POPULATIONS PARTICULARLY THOSE
WHO HAVE BEEN TRADITIONALLY
DISADVANTAGED WHERE THEY'RE IN
RURAL COMMUNITIES OR COMMUNITIES
OF COLOR, WE WILL WEEP AN EYE ON
THAT AND THEN WITH RESPECT TO
THE VANGUARD STUDY THAT ENCLUEDS
7 CENTERS AND ALSO THE U.S.
DEPARTMENT OF DEFENSE, U.S.
DEPARTMENT OF VETERAN AFFAIRS,
IT'S A LOT OF THESE INCORPORATED
INTO THE CENTERS WHICH IS AN
IMPORTANT THING AND 1 OF THE
THINGS THAT WE'RE THEEPING TO DO
IS CREATE AND MOVE FORWARD A
LODGE LAT FORM THAT CAN PROVIDE
SOME RANDOMIZED CONTROL TRIALS
RELATED TO NSAID USE, BUT IT'S
REALLY TO IMPLEMENT STRATEGIES
TO ENABLE US TO THINK ABOUT THE
ENTIRE CONTINUUM OF CARE.
SO WE REALLY HAD A GREAT ROBUST
DISCUSSION ABOUT THAT, WE COULD
HAVE TALKED LONGER AND 1 THINK
THIS THAT MR. RON WHO ASKED THE
QUESTION WHO ASKED HOW WOULD
DR. RATHMILL WHO'S BEEN DOING
THIS, I THINK IT'S AGAIN
IMPORTANT TO NOTE IT'S ABOUT THE
COMMUNITIES WE NEED TO ASK THE
REQUEST COMMUNITIES HOW DO WE DO
THIS AND HOW DO WE PROMOTE THE
KREENING AND THAT WAS A HUGE
COMPONENT OF THE SOME OF THE
WORK SO PART OF WHAT THE
SUBCOMMITTEE WILL HAVE TO DO IS
THINK ABOUT WHAT ISLET RESOURCE
TO MOVE THAT FORWARD AND HOW DO
WE INCORPORATE THE COMMUNITY
INTO OUR RESEARCH GOING FORWARD
AND THAT WILL BE GREAT.
AND THEN SECONDLY WE HAD A
WONDER OF DISCUSSION BY
DR. SONIA SPRING FIELD WHO WE
KNOW IS THE DIRECTOR EVER FOR
THE VERY NEW CENTER FOR CANCER
HEALTH EQUITY AND SHE ACTUALLY
PROVIDED SOME RATIONAL FOR THE
NAME CHANGE WHICH AS YOU HEARD
IT MOVES FROM DESCRIBING THE
NEGATIVES BUT SAYING WHAT IS IT
THAT THAT WE CAN ALL DO AND MOVE
THINGS INTO A POSITIVE DIRECTION
AND WHAT ARE THE WAYS WE CAN
ACTUALLY ELEVATE COMMUNITIES,
BUT THEN ALSO TALKED ABOUT SOME
OF THE RESTRUCTURE THAGOREAN'S
TAKEN PLACE BECAUSE SOME OF THE
PROGRAMMATIC WORK REALLY KIND OF
FITS WITH SOME OF THE NAME
CHANGES WITH RESPECT TO EQUITY
AND SO, YOU KNOW SHE TALKED
ABOUT THE CCAG CORE WHICH IS
SEEKING TO EXPLORE STRATEGIES
FOR EQUITABLE PARTICIPATION FOR
UPDATER SERVED COMMUNITIES BY
DIRECTION AND CANCER DISPARITIES
RESEARCH.
MANY FOLKS KNOW ABOUT THE CURE
PROGRAMS WHICH FITS UNDERNEELGT
THERE, ALSO KIND OF TALKING
ABOUT THE TEAM WHICH IS
TRANSFORMATIONAL EDUCATIONAL
ADVANCEMENT AND MENTORING
NETWORK, AND REALLY IMPORTANT TO
MAKE SURE WE'RE PAIRING THOSE
EARLY STAGE VERY LONGS YOU TALK
ABOUT, WITH OTHER INDIVIDUALS
WHO CAN HELP MENTOR THEM ALONG
THE ENTIRE RESEARCH CONTINUUM,
BUT SHE ALSO KIND OF TALKED
ABOUT SOME OF THE OTHER
DIFFERENT COMPONENTS OF THE
CCHE, I WILL NOT GO THROUGH IT
BECAUSE YOU WILL IMET NOTES ON
THIS, BUT I THOUGHT IT WAS
REALLY IMPORTANT AGAIN FOR US TO
UNDERSTAND THE DEPTH AND BREDTH
OF WHAT THE CCAT DOES, SO THAT
WE CAN SAY, HOW DO WE LEVERAGE
THAT, HOW DO WE ACTUALLY TAKE
WHAT'S ALREADY EXISTING
INFRASTRUCTURE WITHIN THE NCLRKS
I AND SAY HOW DO WE LEVERAGE
WHAT DR. SPRING FIELD'S GROUP
DOING TO THINK ABOUT POPULATION
HEALTH IN A DIFFERENT WAY AND
MAKE ITS SO THAT WE ARE WORKING
COLLABORATIVELY.
AMERICA REALLY RYED TO LEVERAGE
THE THINGS THAT ARE HAPPENING IN
CCHE, THAT ARE HAPPENING IN
SILOED PART OF THE NCI TO WORK
COLLABORATIVELY TOGETHER AND
HELP ANSWER THESE IMPORTANT
QUESTIONS.
ONE OF THE OTHER THINGS THAT
DR. SPRING FIELD DID TALK ABOUT
IN ADDITION TO THE CANCER
MOONSHOT SCHOLARS PROGRAM WHICH
IS FANTASTIC AND SUPPORTED BY
THE WHITE HOUSE, IT IS REALLY
ALSO TALKING ABOUT THE
IMPORTANCE OF THIS NEWLY SPRUCED
CANCER EQUITY LEADERSHIP GROUP
OR LEADERS BROWP THAT
DR. RATHMILL DISCUSSED REALLY
IMPORTANT TO KIND OF START TO
RETHINK, IF WE'RE GOING TO
REALLY GET TO THE POINT WHERE
EQUITY IS TRULY A MOAJOR
COMPONENT OF WHAT WE'RE REACHING
FOR AND STRATEGIZING ABOUT HOW
DO WE KIND OF PULL IN ALL
COMPONENTS AGAIN, WE HAVE CANCER
CENTER DIRECTOR WHO IS ARE PART
OF THE SALE, THERE ARE
INSTITUTION TRUSTEESS THAT ARE
PART OF CELL AND HOW CAN WE
PUBLISHED TLGT THIS CADRE OF
INDIVIDUALS WHO NOT ONLY
REPRESENT DIFFERENT DIVERSE
COMMUNITIES BUT CAN BE LEVERAGED
AS ROLE MODELS BUT ALSO THEIR
EXPERTISE IN HOW THEY GOT FROM
.8 TO POINT B IS REALLY RELEVANT
AND IMPORTANT NOT ONLY TO
RESEARCH BUT ALSO TO ENGAGE IN
THE COMMUNITIES.
SO AGAIN, I THINK WE HAD A
REALLY ROBUST CONVERSATION
AROUND THAT, AND THEN FINALLY,
WE REALLY SAID THAT FOR THE
SUBCOMMITTEE WE WANT TO START
IDENTIFYING AREAS THAT THE
SUBCOMMITTEE CAN ACTUALLY DO A
LITTLE BIFF OF RESEARCH SO I CAN
ADVICE, SO IF YOU HAVE IDEAS OR
THINGS THAT THIS SPECIFIC
SUBCOMMITTEE CAN ACTUALLY HELP
TO WORK ON WE HAD SOME GREAT
IDEAS THAT CAME OUT YESTERDAY,
BUT I THINK AGAIN IF WE'RE
THINKING ABOUT EPIDEMIOLOGY,
POPULATION HEALTH, DISPARITIES,
OUR DIVERSITY WHAT ARE THE
THINGS YOU WOULD LIKE TO SEE,
THIS IS WORK WE WILL DO MORE
DEEP DIVE OVER THE NEXT COUPLE
OF WEEKS WITHIN THE SUBCOMMITTEE
ITSELF, WE WILL BE SENDING OUT A
SURVEY TO THE MEMBERS BUT THAT
INCLUDES, WE WANT TO HEAR YOUR
VOICES AS WELL, AND THEN IN
SEPTEMBER, WE'RE GOING TO START
TO GET TO WORK.
SO WITH THAT I AM HAPPY TO TAKE
QUESTIONS.
NTHANK YOU KAREN.
>> WE WILL TART WITH CHUCK AND
GO TO ANN--HOSPITALS HAVE AND
HAVE THAT OPPORTUNITY FOR US TO
DO WORK THERE AND LASTLY, EARLY
DETECTION, SO WE TALK ABOUT
MSTAT BUT I THINK THERE'S
OPPORTUNITY FOR US TO GROW SO
FIGURE OUT HOW WE DO BETTER AT
DETECTING CANCER SAFELY AND
EFFECTIVELY BECAUSE, MAYBE THE
LAST THING IS WE LOSE THE STORY
ON THE SCREENING BECAUSE IF WE
THINK WE TELL THE STORY AND WE
NEED IT PERFECTED, MAYBE SCIENCE
HASN'T DONE A GREAT JOB, WE NEED
TO DO BETTER AT TELLING THIS
STORY AT WHAT SCREENING NEEDS.
>> THANKS TREY.
NANN?
>> NOW I BRING UP A STICKY
SUBJECT, SO THE MSTATS
ESSENTIALLY WE TALKED ABOUT TIS
ABLED A COUPLE TIMES.
>> COULD YOU PULL THE AMERICA IC
CLOSER.
>> I'M USUALLY LOUD ENOUGH, SO,
YOU KNOW IESM WOBDERRING THESE
ARE ALL LAB RAARE TOY TESTS,
EVERY I THINK ISLE 1 OF THEM SO
FAR AND THEY'RE MOSTLY IN THE
PRIVATE SECTOR AND WE ARE NOT
REGULATING THEM AT ALL, NOW, IN
THE SENSE THAT THE LEVEL OF
EVIDENT REQUIRED TO GET THEM
INTO PATIENTS IS NOT THERE AND I
DON'T KNOW WHAT WE DO.
WE DO HAVE AN FDA REP I SEE BACK
THERE BUT FDA JUST STEPPED
FORWARD AND SAID WE WILL DO
SOMETHING ABOUT THIS BUT I WOULD
ARGUE THAT THE FINANCIAL
TOXICITY THAT'S GOING TO HIT US,
BECAUSE THESE ASSAYS ARE OUT
THERE, THEY'RE BEING SOLD, I
WEPT TO MRI PHYSICIAN 2 WOKES
AGO AND THERE IT WAS, I GIVE
GIVE THEM A THOUSAND DOLLARS AND
GET MY GALLERIA TEST DONE AND
I'M NOT SURE WHAT I DO WITH THAT
DATA, RIGHT?
SO I MEAN, IS THERE ANYTHING
THAT WE'VE THOUGHT ABOUT DOING
MAYBE WITH THE FDA OR HOUR DO WE
GET THESE TESTS UNDER SOME
SEMBLANCE OF THE CONTROL SO WE
GET DATA WE KNOW MEANS SOMETHING
AND WE CAN START THINK ABOUT
LIMITING THE FINANCIAL TOXICITY
THAT WILL DERIVE FROM THIS, IT'S
GOING TO BE HYG AND YOU KNOW I
DON'T KNOW IF FDA WANTS TO
COMMENT?
NHOW ARE WE GOING TO FIX IT, I
WANT TO KNOW?
>> CAN YOU PULL THE AMERICA IC
CLOSER.
>> THIS IS A LITTLE BIT OUT OF
MY WHEEL HOUSE BUT I MEAN, THERE
WAS THIS RECENT LDT RULE THAT
WAS JUST PASSED AND IIME NOT A
CDRH REPRESENTATIVEIME WITH THE
COES SO I'M NOT IN A POSITION TO
COMMENT AND IT'S AN INTERESTING
ADVANCEMENT IN THIS AREA WE'RE
GETTING BETTER, TRAY.
>> I WAS GOING TO NOT DELVE INTO
THIS BUT BECAUSE DR. BARKER DID,
I WILL CHIME IN, I MEAN I THINK
THAT OF COURSE NSAID IS VERY
EXCITING CHALLENGE FOR ME AND
MARKERS AND THESE ARE NOT AND
AND I THINK THIS TECHNOLOGY IS
INVOLVEDDA FROM SINGLE MUTATIONS
EARLY DETECTION AND WE HAVEN'T
ACHIEVED PERFORMANCE THAT'S
REQUIRED, LIKE WE SAID BEFORE WE
MIGHT BE GETTING TO A POINT
WHERE WE INTRODUCE MORE
TOCKISSITY AND WE RECENTLY GET A
DISCUSSION ABOUT THIS TOPIC, IS
MSAID READY OR IS THIS
TECHNOLOGY BETTER SUITED FOR
TUMOR SC AND SHOULD THAT BE THE
FIRST STEP FORWARD IT'S A
DISCUSSION TO HAVE
ESPECIALENTIALLY BEFORE WORKING.
NYEAH, VERY CONTROVERSIAL AND
PROVOCATIVE TOPICS SO WE'RE ON
THE TOPIC OF CONTROVERSY AND
STICKY SUBJEKS SO I'VE BEEN AND
COMPLICATIONS WITHOUT
NECESSARILY TREATING MEDICAID
PATIENTS AND SO, DR. WHAT COULD
BE STUDIED AND I THINK, YOU KNOW
THIS COULD BE SOMETHING THAT
COULD BE VERY INTERESTING ACROSS
THAT SUBMITEE ACROSS THE
SUBCOMMITTEE FOR CANCER CENTERS
AND I THINK ABOUT UNDERSTANDING
THE KINDS OF RESEARCH AND
ENROLLMENTS THAT ARE ENROLL
INDEED CANCER CENTERS THAT DO
AND DON'T AND THEN USING THAT TO
ADVOCATE, AND WE NEED THE DAILY
BASIS THEA TO SEE THERE'S A
DIFFERENCE AND GIVE THE ADVIE WE
NEED TO WORK ON CHANGING THAT IF
ACTUALLY ENROLLING PATIENTS, YOU
KNOW THAT ALSO IS NOT JUST
DIVERSITY OF RACE BUT ALSO
POVERTY.
>> YES, GETTING TO POLICY.
YEAH.
>> I THINK POAGHT OF THOSE ARE A
GOOD POINT.
I WILL GO BACK TO NSAIDS JUST
BRIEFLY BECAUSE MY TEAM RECENTLY
DID A STUDY OF ADHERENCE TO 1 OF
THE BLOOD TESTS FOR COLORECTAL
CANCER AND WE CONDUCTED
QUALITATIVE INTERVIEWS WITH
PATIENTS AND I THINK WHAT REALLY
CONCERNED ME WAS 2 THINGS, 1 IS
THAT PATIENTS WERE
OVERWHELMINGLY ENTHUSIASTIC SO
OUR CODE IS, I WAS SCREEPING
HALLELUJAH, I WOULD HAVE GIVEN A
GALLON OF BLOOD TO NOT HAVE TO
HAVE DONE A COLONOSCOPY, RIGHT?
HIKE OH NO, AND THE OTHER THING
THAT PATIENT SAID WELL OF COURSE
IT'S MORE ACCURATE THAN THE
OTHER TESTS BECAUSE THIS IS YOUR
BLOOD.
AND YOUR BLOOD TELES YOU
EVERYTHING, RIGHT?
AND SO EVEN THOUGH WHEN YOU LOOK
AT THE PERFORMANCE
CHARACTERISTICS SO FAR WITH SOME
OF THESE TESTS ARE WAY INFERIOR
TO THE OTHER MUCH CHEAPER, YOU
KNOW MORE ACCESSIBLE METHODS
THAT ARE OUT THERE, AND SO THAT
CERTAINLY CONCERNED ME AND I DO
THINK THAT JUST BUILDING ON KIND
OF THIS IDEA OF WHAT ARE THE
EXPECTATIONS THAT WE HAVE OF
COMPREHENSIVE CANCER CENTERS, I
THINK WE NEED TO THINK ABOUT
PUTTING OUT PUBLIC STATEMENTS,
ADVOCATING TO MAKE SURE THAT THE
HORSE DOESN'T LEAVE THE BARN TOO
QUICKLY AND WE'RE DEMAND THRG'S
GOOD PERFORMANCE FOR SOME OF
THEZ THINGS BEFORE THEY GET OUT
FOR PUBLIC USE AND THE
ADVERTISING DOESN'T TAKE OVER.
>> LAST COMMENT, RAY?
>> YOU KNOW I SAID YOUR NAME
RIGHT?
>> SPOORKS SPEAKING OF
ADVERTISING AND GETTING IN FRONT
OF EVIDENT, I HOPE EVERYBODY IS
AWARE THAT THERE'S MANY YEARS
LONG EFFORT IN DRONG SOMEHOW
SHOVE THIS MSAID, COMMERCIAL
NSAID THING FAST TRACK IT WELL
PAST THE SCIENCE SO OUR
COLLEAGUES AT NCI, PLEASE BE
AWARE OF THIS IF YOU'RE NOT
ALREADY AND A NUMBER OF US
CONTINUE TO SPEAK TO OUR
CONGRESS PEOPLE TO SAY, LOOK,
THIS IS CRAZY, PLEASE PUT THE
BREAKS ON THIS, BUT, YOU CAN
TELL THAT THERE'S A VERY WELL
FUNDED EFFORT THAT IS TRYING TO
CIRCUMVENT THE PROCESS SO JUST
BE AWARE OF THAT.
>> GREAT POINT.
ALL RIGHT, YOU GET THE LAST
QUESTION.
NJUST 1 POINT QUICKLY ABOUT
THAT, WE WENT OUT AND TALKED
ABOUT THAT AND WHAT WOULD HELP
US IS HAVE A CALCULATION OF THE
FINANCIAL IMPACT IF THESE TESTS
BECOME RAPIDLY IMPRESSED INTO
CLINICAL CARE AND I KNOW THERE'S
FINANCIAL IMPACT FOR THE HELT
CARE SYSTEM, TO HAVE THOSE
NUMBERS AT OUR HANDS TO TAKE TO
OUR CONGRESS PEOPLE AS WE LIKE
FINANCIAL TOXICITY AND OTHER
POINTS NTHAT'S AN ANYTHING
SPOINT, YESTERDAY AT LUNCH ISA
BELL RAN A CHAT GPT ASKING THAT
VERY QUESTION AND THE RESULT WAS
VERY INTERESTING.
I WON'T ANY INTO THAT BUT IN THE
INTEREST OF TIME LET'S MOVE ON
THE NCAB NUMBERS SOME SHOAT TO
ACCEPT THE REPORT THAT WAS
PROVIDED BY DR. WING FIELD, IS
THERE A MOTION?
SECOND?
PROPERLY MOVED AND SECOND?
ANY DISCUSSION IN THERE BEING NO
1 LET'S VOTE.
ARE THERE ANY NAYS?
ANY ABSTENTIONS?
UNANIMOUS.
OKAY GREAT SO THE FINAL
SUBEXITEE REPORT WILL BE BROUGHT
TO US BY DR. RICHARD BOXER WHO
THERS THE AD HOC SUBDMITEE ON
EXPERIMENTAL THERAPEUTICS,
RICHARD.
NTHANK YOU VERY MUCH.
AS A DEMONITRATION OF ENTHUSIASM
AND ENGAGEMENT OF OUR
SUBCOMMITTEE IT MET BETWEEN 8
AND 9 OOH CLOCK AND EVERYONE WAS
STILL AWAKE AT THE END.
WELL, MAYBE NOT EVERYONE BUT
PEOPLE DID STICK AROUND TILL THE
END.
I WANTED TO SAY A COUPLE THIJS,
FIRST OF ALL, DR. OROJAMA HAS
BEEN INCREDIBLY SUPPORTIVE AND
HELPFUL AND DR. GRAY HAS BEEN
KEEPING US IN THE GUARD RAILS
AND BEEN VERY, VERY HELPFUL FOR
THE SUBCOMMITTEE BECAUSE THE
SUBCOMMITTEE ORIGINALLY CAME
INTO BEING ABOUT 20 YEARS AGO
AND THEN QUICKLY WENT TO SLEEP
SPEAKING ABOUT 8 OH CLOCK OR 9
ARK CLOCK WENT TO ASLEEP FOR
ABOUT 10 OR 15 YEARS AND NOTHING
WAS DONE AND WHEN I WAS ASKED
INEXPLICABLY IN MY MIND TO LEAD
IT, I WENT BACK AND LOOKEDDA THE
VISUAL OR THE MISSION STATEMENT,
NOW THIS IS FOR EXPERIMENTAL
THERAPEUTICS AND NOTHING HAD
BEEN DONE FOR 20 YEARS, AND SO
WITH THE HELP OF THE SUBMITEE
AND WE WERE VERY PLEASED THAT
DR. CARPTEN AND WERE ALL
SUPPORTIVE OF THE COMMITTEE
THERE, WE DECIDED AS A
SUBCOMMITTEE EARLY ON THAT WE
WERE GOING TO CREATE A NEW
MISSION STATEMENT BECAUSE AFTER
ALL IT'S BEEN A LONG TIME AND
WE'RE SUPPOSED TO BE
EXPERIMENTAL LOOKING AT THE
HORIZON AND SO AS A GOAL, FOR ME
AND FOR THE SUBCOMMITTEE WAS TO
CREATE A NEW MISSION STATEMENT
WHICH IS IN YOUR FOLDERS, AND
WE--IT TOOK 15 OR SO ITERATIONS
OVER THE PAST 6 MONTHS BUT WE
FINALLY BROUGHT SOMETHING
TOGETHER THAT WOULD INCLUDE--WAS
BROUGHT ENOUGH TO HAVE AN
UMBRELLA FOR ANYTHING WE WOULD
BE INTERESTED IN AS GROUP, AS AN
NCAB TO LOOK AT BUT HAVE SOME
SPECIFIC IDEAS IN ORDER TO
DEVELOP ACTIONABLE ITEMS SO
WITHIN THAT MISSION STATEMENT,
WE HOPE THAT WE WERE ABLE TO
INCLUDE EVERYTHING, ALTHOUGH I
MUST SAY THAT DR. LOPEZ ADDED
COMMUNITIES WHICH WAS REALLY
IMPORTANT AND THOSE WORDS
RESEARCH ADDED INTO THE MISSION
STATEMENT.
IN ADDITION TO THE CREATION OF A
NEW MISSION STATEMENT, WE ALSO
DECIDED THAT, IT WOULD BE VERY
IMPORTANT TO UTILIZE, THE
KNOWLEDGE OF THE NCAB MEMBERS
AND INCLUDING AND SPECIFICALLY
THE SUBCOMMITTEE MEMBERS BUT THE
NCAB AS A WHOLE TO BE ABLE TO
USE THE TALENT THAT THE NCAB HAS
WITHIN IT AND TO AMRI THAT TO
THE EXPERIMENTAL THERAPEUTICS
AND O WITH THAT IN MIND, WE
BELIEVE IN--WE'VE GOTTEN
DR. RATHMILL HAS BEEN KIND
ENOUGH TO SUPPORT THIS, WE ARE
ANYTHING TO HAVE A CONFERENCE,
SUMMIT, WORKSHOP, WHATEVER WE
WILL ULTIMATELY CALL IT, IT WILL
BE BRINGING THE RELEVANT
PARTNERS AND ACADEMIA, THE NCAB,
AND THE NCI, PRIVATE SECTOR TO
TALK ABOUT AND DEVISE 3, PERHAPS
3, BECAUSE WE HAVE TO BE
SOMEWHAT LIMITED ACTIONABLE
ITEMS FOR THE FUTURE OF
THERAPEUTICS IN FOR THE PATIENT.
AND THE PATIENTS CARES ABOUT
THERAPEUTICS, DIAGNOSTICS AND
ULTIMATELY THIS IS WHAT WE'RE
ALL ABOUT, TO HELP THE PATIENT
AND SO WITH THAT IN MIND, WE'RE
GOING TO--WE PROPOSE NOT ONLY
THE MISSION STATEMENT BUT ALSO
TO HAVE--TO CONVENE A
CONPRESENCE WHICH WILL PROBABLY
BE OCTOBER MAYBE WITH THE HELP
OF ALL THE STAFF THAT IS
NECESSARY AND SOME OF US WILL BE
MORE INVOLVED THAN OTHERS, BUT
WE'RE SURE GLAD TO HAVE STAFF,
AND IN ANY CASE, IT'S--I THINK
THAT THAT WILL BE VERY VALUABLE
FOR ALL OF US IN PARTICULARLY
FOR THE PATIENTS.
WE TALKED ABOUT THE CONCURRENCE
OF THE TBRAIT MISSION STATEMENT
AND RECEIVED GREAT INPUT FROM
THE MEMBERS AND WE TALKED ABOUT
THE FOCUS AREAS OF FUTURE
AGENDA, AND GOT WONDERFUL
COMMENTS FROM DRS. LOPEZ,
CARPTEN, [INDISCERNIBLE] AND
BARKER AND SO WITH ALL THE
INFORMATION THAT WE'RE ABLE TO
BRING TO THE SUBCOMMITTEE AND
NOW WE'RE BRINGING IT TO THE
NCAB, WE'RE HOPEFUL THAT THE
NCAB WILL VOTE ON AND ACCEPT OUR
MISSION STATEMENT AS WELL AS THE
IDEA OF HAVING A CONFERENCE TO
BRING TOGETHER ALL THE
STAKEHOLDERS, RELEVANT PEOPLE
AND HAVE THE WHICH SOME PEOPLE
MIGHT BE THE BEATING HEART AND
THE SOUL OF THE NCI FOR THE
SUPER INCREDIBLE POTENTIAL
THERAPEUTICS THAT WILL COME TO
THE PATIENT.
THANK YOU.
>> THANKS RICHARD.
QUESTIONS DR. BOXER?
COMMENTS?
>> JULIE?
>> I WILL LIKE TO SAY THANK TO
YOU OUR OMAZING CHAIR AND TO
ROSE FOR HER LEADERSHIP.
WE WILL LOVE FOR YOU GUYS TO
SHOW UP THIS MEETING, IT IS A
LOT OF FUN.
THIS IS THINKING MORE OF A
COMMENT WHICH IS PART OF WHAT
OUR ARK MAZING LEADERS HERE AT
THE NCI NEED TO DO IS INSPIRE
CONGRESS TO FUND US, AND THE
INSPIRATION OF HOW WE CAN BRING
NEW TREATMENTS TO PATIENTS OFTEN
IS THROUGH THE INCREDIBLE DATA
WE GET TO SEE AT ASCO AND OTHER
CONFERENCES WHERE WE SEE A MASS
INSIDE A HUMAN'S BRAIN AND THEN
IT DISAPPEARS AND SO, I THINK
THAT FINDING A WAY TO ENGAGE
AROUND EXPERIMENTAL THERAPEUTICS
AND ALSO EMBRACING TECHNOLOGY SO
WE CAN COMPLETE THESE TRIAL
NOSTHE COMMUNITY AND SCALE OUR
WORKFORCE WILL BE REALLY
IMPORTANT TO UNDERSTAND FROM A
MULTIPASQUANTINO AT THE TIMED
PERSPECTIVE AND AS A MEMBER
REPRESENTING SMALL BIOTECH THIS
WILL BE AN IMPORTANT
CONVERSATION ACROSS STEAK
HOLDERS TO HAVE YOU PARTICIPATE
IN AND I WANT TO SAY THANK TO
YOU THE NCI FOR RESURRECTING
THIS COMMIT EYE.
IT IS FANTASTIC AND I THINK THAT
WE WILL DO GREAT THINGS TOGETHER
FOR PATIENTS.
NQUESTIONS?
>> GREAT PRESENTATION AND
EXCITING WHAT WILL BE THE OUT
PUT OF THE MEETING IN THE
CONFERENCE?
>> WELL THE CONFERENCE WE HOPE
WILL BRING TOGETHER THE MINDS
AND ENTHUSIASM OF THE VARIOUS
STAKEHOLDERS TO FIND THERE MAY
BE 12, MAYBE 15 DIFFERENT AREAS
THAT WILL BE EXTRAORDINARILY
IMPORTANT FOR THE THERAPEUTICS
FOR THE EXPERIMENTAL
THERAPEUTICS BUT WE HAVE TO PAIR
THAT DOWN TO MAYBE 3 AND SAY,
OKAY FINE, AND IN THE NEXT 3
YEARS WE WILL ACCOMPLISH ALL 12
BUT IN THE FIRST YEAR OR 2 WE
HAVE TO DO 3 ONLY BECAUSE WE
WANT HAVE THE WILL, WE JUST MAY
NOT HAVE THE WAY BECAUSE THERE'S
JUST NOT ENOUGH MONEY, BUT AT
LEAST WE'LL HAVE SOME OF KIND OF
A PATHWAY TO IMPROVING THE
THERAPEUTICS AND FOR THE PATIENT
AND THAT UNTO ITSELF WILL BE
INSPIRING HOPE FOR THE
POPULATION FOR AMERICAN ANDS FOR
WORLD WIDE AS FAR AS IT GOES
TOWARDS CANCER CARE.
>> I GUESS CLARIFICATION FROM
ME, SO THE COMMITTEE IS GOING TO
CONVENE, CREATE A REPORT, SO
ADVISE N NCI, SO THE COMMITTEE S
TO THE 1 DOING THE WORK ON
PRPLTAL THERAPEUTICS, RIGHT?
>> THAT'S CORRECT.
WE ARE AN ADVISORY COMMITTEE,
ANAD HOC ADVISORY COMMITTEE TO
DR. RATHMILL AND THE NCI AND HOW
ULTIMATELY IT IS USED TO WILL BE
UP TO THE NCI, NOT UP TO US BUT
WE WANT TO INSPIRE HOPE AND
ENTHUSIASM WITHIN ALL THE
COMMUNITY, ALL THE STAKEHOLDERS,
SO THAT WE'RE ALL WORKING
TOGETHER.
NTHANKS SO MUCH, I WANT TO ECHO
ON YULEY'S COMMENTS AND
DR. BOXER'S COMMENTS TO INSPIRE
ENTHUSIASM AND ENERGY AND
MOMENTUM PARTICULARLY FOR OUR
MEMBERS OF CONGRESS AS WELL
GIVEN THE STRUCTURAL ISSUES WE
HEARD ABOUT THIS MORNING, SO I
THINK THERE WILL BE A DPRAIT
OPPORTUNITY FOR THIS MEETING TO
INCLUDE PATIENT ADVOCATES AS
WELL AS THE BROADER CANCER
ADVOCACY COMMUNITY IN GENERAL,
SO THAT THEY ARE FULLY BRIEFED
ON WHERE NETWORK CI EXPERIMENTAL
THERAPEUTICS IS TODAY, WHERE IT
BEING BE IN THE FUTURE AND WHAT
NEEDS TO HAPPEN PER THAT FUTURE
TO OCCUR BECAUSE WE WOULD NEED
SOMETHING VERY DIFFERENT IF WE
WANT A REALLY EXCITING FUTURE
FOR EXPERIMENTAL THERAPEUTICS.
NETWORK AS IT APPLIES TO THE
CONGRESS, WE'VE BEEN TOLD
REPEATEDLY BY DR. GRAY THAT WE
AS NCAB MEMBERS CANNOT LOBBY
CONGRESS AND SO, WITH THAT IN
MIND, WE CAN HAVE PATIENT
ADVOCATES DO THAT FOR US SO I
THINK THAT WOULD BE--IT'S A VERY
GOOD IDEA.
WE WILL HAVE THEM MARCH--I
PERSONALLY WENT BUYER I WAS ON
THE NCAB OR IN BETWEEN
DIFFERENT--I WAS IN ON THE NCAB,
I WENT TO CONGRESS FOR A
LYMPHOMA AND LEUKEMIA GROUP AND
IT WAS CALLED THE OUTER ROOM WAS
CALLED MOTHER TERESTIMATE THAD'S
WAITING ROOM BECAUSE EVERYONE
WAS ANYTHING INTO THE CONGRESS
BEGGING FOR MONEY.
AND IT WAS MA EFFECTIVE, QUITE
EFFECTIVE, ACTUALLY, BUT ONCE
AGAIN, IT'S ADVOCACY GROUPS THAT
CAN ADVOCATE THE NCAB CAN JUST
EDUCATE.
>> GREAT.
THANKS DR. BOXER, GREAT
DISCUSSION, SO NCAB MEMBERS,
SHOULD VOTE TO ACCEPT THE
REPORT.
IS THERE A MOTION?
>> I HAVE A BIT OF A CONCERN
RAISED EARLIER IT WAS MAKING ME
EAT ABOUT THE MCEDs AND NOW
AND HOW ENTHUSIASTICALLY THE
APPROXIMATE UBIQUITINNATION LICK
IS PICKING UP ON THIS, I KNOW
FOR A FACT THAT IN CALIFORNIA
THERE WAS A WHOLE CONSORTIUM OF
FOLK WHO WERE MOVING TO WRITE
LETTERS TO CONGRESS, AND I HAVE
NEW DATA THAT ADVOCACY LETTER VS
SIGNED GROUPS WRITING LETTERS TO
CONGRESS PUSHING MCED COVERED
THROUGH MEDICARE SO WHAT I AM
THINKING IS THE COMMUNITIES NEED
TO BE EDUCATED BECAUSE CERTAINLY
THEY WANT EXPERIMENTAL DRUGS
THAT WILL MAKE A DIFFERENCE IN
THEIR LOVE 1S LIVES BUT IF WE'RE
MOVING TOO FAST FOR CAPITALISM
IS MOVING FASTER THAN THE
SCIENCE, AND THERE ARE PEOPLE
WHO REALLY WANT TO MAKE A DOLLAR
AS OPPOSED TO CONCERNED ABOUT
THE SAFETY AND WELFARE OF
PATIENTS OR EVEN THE
DISAPPOINTMENT OF PATIENT WHO IS
WILL NOT GET THE RIGHT KINDS OF
DIAGNOSIS AS A RESULT OF THESE
TESTS OR THE WRONG DIAGNOSIS OR
LED DOWN THE WRONG PATH SO I'M
SIMPLY SAYING THAT WE NEED
SOMEHOW AS NCI TO CREATE SOME
KINDS OF EDUCATIONAL TOOL KITS
AROUND THESE TO GET BACK INTO
THE HANDS OF THESE COMMUNITY
GROUPS SO THEY'RE NOT JUST, WOW,
THIS IS GREAT, WELL THE'S GO GET
THIS, AND THEY'RE JUMPING ON
THESE BAND WAGONS BECAUSE THEY
THINK THAT IT'S CRITICAL AND
THEY WANT TO GO TO CONGRESS AND
LOBBY FOR THE DOLLARS TO DO THIS
AND WHEN THIS FACT IT WILL NOT
BE GOOD FOR THE COMMENTS AND THE
PATIENTS I'VE ALWAYS BEEN
CONCERNED FOR THE PATIENT AND WE
NEED TO LEND A HAND AND REACH
BACK OUT INTO THE COMMUNITIES
AND PATIENT ADVOCATE GROUPS TO
PROVIDE THEM WITH A SLOW DOWN.
NJUST 1 LAST, I THINK THAT WE
CAN WALK AND CHEW GUM AT THE
SAME TIME.
THAT IS WE CAN FORCE OR IMPROVE
THERAPEUTICS AND THEN I'VE BEEN
PASSIONATE ABOUT GETTING ACCESS
FOR ALL PATIENTS WITHIN THE
UNITED STATES OR AROUND THE
WORLD FOR THE EXCITING POTENTIAL
THERAPEUTICS DIAGNOSTICS, ET
CETERA, THE ACCESS TO CARE AND
TERRIBLE AND THAT'S SOMETHING
THAT I ACTUALLY THINK, YOU KNOW
IS TERRIBLY CRUEL IN THAT WE CAN
MAKE AN ANNOUNCEMENT THAT
THERE'S A CURE, THERE'S A
THERAPEUTICS OR WHATEVER, BUT
YOU CAN'T GET IT.
I MEAN THAT'S REALLY ADDING
INSULT TO YOUR AND IT'S
SOMETHING THAT WE MUST DO BUT AT
THE SAME TIME, I THINK THE OTHER
PORTION IS, WE CAN CONTINUE TO
HAVE GREAT ADVANCEMENTS AND THEN
SOMEHOW FIGURE OUT HOW TO BRING
THOSE ADVANCEMENTS TO ALL
POPULATIONS.
NOKAY, SO LET'S WRAP IT UP.
I THINK THERE'S AN OPPORTUNITY
PERHAPS FOR THE OCTOBER MEETING
TO INCLUDE ADVOCACY, PATIENTS
AND COMMUNITY.
SO LET'S GO ON TO THE VOTE, THIS
WILL BE FOR THE NCAB MEMBERS,
THE VOTE IS TO ACCEPT THE
REPORT.
IS THERE A MOTION IN?
>> SECOND, PROPERLY MOVED AND
SECOND, FURTHER DISCUSSION?
OKAY, WE WILL VOTE.
ARE THERE ANY NAYS?
ABSTENTIONS?
UNANIMOUS.
SO THE BOARD MEMBERS HAVE A COPY
OF THE ADHOC SUBCOMMITTEE ON
EXPERIMENTAL THERAPEUTICS
REVISED MISSION STATEMENT.
NOW THAT THE REPORT HAS BEEN
ACCEPTED, THE BOARD HAS TO ALSO
VOTE TO ACCEPT OR NOT ACCEPT THE
NEW MISSION STATEMENT SO IS
THERE A MOTION TO ACCEPT THE NEW
MISSION STATEMENT.
SECOND?
FURTHER DISCUSSION?
OKAY, WE'LL VOTE ANY NAYS,
ABSTENTIONS?
IT'S UNANIMOUS.
SO MOVING ON THORS OTHER
BUSINESS, ARE THERE OTHER
THOUGHTS, ISSUES, CONCERNS,
RECOMMENDATIONS THAT ANY OF THE
BOARD MEMBERS WOULD LIKE TO
SHARE SORE THAT THE BOARDS AND
NCI SHOULD CONSIDER GOING
FORWARD?
YES?
>> SO JUST IN THINKING ABOUT THE
MORNING, INCREDIBLY AMAZING
CONVERSATIONS WE'VE HAD, AND
THINKING ABOUT WHAT WE MIGHT
WANT TO HEAR MORE ABOUT, I
WONDERED, I WOULD LOVE TO LEARN
MORE ABOUT HOW THE NCI, THE NIH
REALLY COMMUNICATES WITH THE
PUBLIC.
LIKE WHAT IS--HOW DOES THAT
HAPPEN AND WHAT IS THAT PLAN?
AND THEN TO FOLLOW UP ON, WELL
WE WERE JUST TALKING ABOUT, IS
HOW DO WOE ENGAGE WITH
COMMUNITIES?
AND SPECIFICALLY ARE THERE
THOUGHTS, ARE THERE PROJECTS
THAT ARE AROUND BRINGING
TOGETHER COMMUNITY HEALTH
WORKERS.
>> GREATER.
>> SAD TO SEE HENRYS LEAVE THIS
SPACE WHO HAVE BEEN HERE FOR
SEVERAL YEARS BUT ALSO I THINK
CHANGE CAN BE AN OPPORTUNITY TO
THINK ABOUT HOW THESE ARE
DIFFERENTLY AND THINK ABOUT
COMMUNITY ENGAGEMENT I LIKE TO
PERSONALLY CALL IT I'M WONDERING
IF THERE MAY BE AN OPPORTUNITY
TO THINK THROUGH THE CANCER
CENTERS AND ENGAGE WITH
COMMUNITIES AND WHAT'S OUR
MEASURE.
I KNOW THAT QUESTION HAS GONE UP
AND DOWN, IN TERMS OF METRICS
AND EXPECTATIONS ABOUT COMMUNITY
I PACTS WHICH IS A FRAMEWORK
THAT EXISTS NOW WITH THE CTSA SO
THAT'S SOMETHING THAT'S WORTH
THINKING ABOUT WHO CAN'T CONQUER
WORLD HUNGER BUT THE IMPACT CAN
BE POTENTIALLY GREATER ON THE
COMMUNITIES SO YOU KNOW SITTING
NEXT TO THE DIRECTOR, BUT I DO
THINKOOSE AN IMPORTANT
CONVERSATION THAT MAY BE TIMELY
TO ARE IN THE CONTEXT OF THE
WORK, USING IT FOR HEALTH EQUITY
AND THANK YOU VERY MUCH SO FOR
THAT THAT THAT'S EXCITING TO
SHARE.
THAT'S MY PLUG FOR LOOKINGA THE
COMMUNITY ENGAGEMENT NTHANK YOU.
HOWARD?
NETWORKIDE LIKE TO HEAR MORE
ABOUT WHERE WE'RE AT IN TERMS OF
THE MOST RECENT MAJOR INVEST AMS
BY MOON SHOT IS DONE, FOR
INITANCE THE SIMAX VALIDATING
BIOMARKERS TO HELP ACCELERATE
OUR UNDERSTANDING OF AND
OPTIMIZING THE IMPORTANT WORK OF
IMMUNO ONCOLOGY KLUG ANDS
THERAPIES, AND YOU KNOW EVEN
OUTSIDE OF SIMAX, THE CHAIN
ARTICLE I WON'T TALK ABOUT
FURTHER BECAUSE YOU WILL TALK
ABOUT IT LATER YOU SAID,
RECENTLY TOAZ TYPES OF
APPROACHES THAT ARE HERE NOW,
BECAUSE IF FOR INSTANCE, IF THE
BIDEN MOON SHOT FUNDING OR
SOMETHING LIKE IT COMES, IS
ALLOWED, HOW ARE WE GOING TO
BUILD ON WHAT WE'VE LEARNED OR
WHAT THE COMMUNITY HAS LEARNED.
WHAT SHOULD THE NEXT STEPS BE IN
I THINK THAT WOULD BE AN
INTERESTING THOUGHTFUL
DISCUSSION, MAYBE HEARING FROM
PEOPLE LIKE DR. [INDISCERNIBLE]
OR PEOPLE WHO HAVE BEEN DEEPLY
INVOLVED WITH THE SIMAX
PUBLICATIONS THAT HAVE JUST
STARTED TO COME OUT.
>> THANKS, HOWARD.
>> LAST COMMENT FROM KAREN
BEFORE WE NAND WE DON'T HEAR A
LOT ABOUT WHAT'S GOING ON IN
TERMS OF THE NCTN GROUPS ISSUE
THE NCORP RESEARCH BASES, YOU
KNOW WHAT THOSE RESEARCH
PORTFOLIOS LOOK LIKE, WHAT'S
BEING DONE IN THERE AND WHAT WE
SHOULD BE THINKING ABOUT DOING
DIFFERENTLY IN THE FUTURE.
AND THAT'S A WHOLE OTHER ASPECT
OF COMMUNITY THERE IN TERMS OF
THE LAPSE AND NCORPS THAT WE
DON'T TALK ABOUT VERY MUCH OR
HEAR ABOUT VERY MUCH IT WOULD BE
RELLY NICE TO BRING THAT TO THE
TABLE BECAUSE THERE'S A LOT OF
BRAIN POWER ON BOTH OF THESE
COMMUNITIES WHERE POAGHT THOSE
PROGRAMS ARE GOING IN THE FUTURE
AND THEY'RE INCREDIBLY POWERFUL
AND THEIR REACH IS TREMENDOUS.
SO IT WOULD BE NICE TO BRING
THAT TO THE TABLE TO THIS GROUP.
>> THANKS KAREN.
>> DOCTOR YOU GET THE LAST
COMMENT.
>> ONE LAST THING, NCI SHOULD BE
MORE INVOLVED IN ADDRESSING
FINANCIAL TOXICITY.
I THINK THERE'S A LOT OF
INDIVIDUAL RESEARCH ANYTHING ON
BUT SOMETHING COMING UP FROM THE
NCI COULD BE VERY POWERFUL
NGREAT, SO IF THERE ARE ANY
SPECIFIC TOPICS FOR FUTURE
AGENDA ITEMS, SEND THAT TO THE
JOINT MEETING INDIVIDUALS, ME OR
PAULET, IF THERE'S AN INDIVIDUAL
BOARD SELECTION FOR EITHER NCAB
OR BSA, SEND THEM EITHER TO
SHELLY OR PAULET.
SO, WE'LL NOW BREAK FOR LUNCH.
IT'S BEEN AN INCREDIBLE MORNING,
IT'S GREAT SEEING THE FACES AND
THE DYNAMICS AND THE BODY
LANGUAGE IT'S MUCH BETTER THAN
THE VIRTUAL APPROACH I HAVE TO
SAY, IT'S FANTASTIC,
GOOD AFTERNOON, THANK YOU ALL
FOR THE OPPORTUNITY TO PRESENT
OUR RFOOTWORKA CONCEPTS, THE
CONFLUENCE OF CANCER STIGMA AND
HIV STIGMA AND HIV POSITIVE
INDIVIDUALS DIAGNOSED WITH
CANCER, IT'S MY HONOR TO PRESENT
THIS WORK ON BEHALF OF MULTIPLE
PARTNERS HERE AT NCI.
FOR CONTEXT, WE RECOGNIZE
THERE'S STILL A TREMENDOUS
BURDEN OF HIV AROUND THE WORLD.
DPLOABALLY THERE ARE 39 MILLION
INDIVIDUALS LIVING WITH HIV AND
1.2 MILLION INDIVIDUALS HERE IN
THE UNITED STATES.
AMONG PEOPLE WITH HIV, ELEVATED
CANCER RISK IS INFLUENCED BY
MULTIPLE FACTORS ENCLOUDING CO
INFECTION WITH ONCOGENIC
VIRUSES, HIGHER PREVALENCE OF
BEHAVIORIAL RISK FACTORS SUCH AS
TOBACCO USE, INCREASED LIFE
EXPECTANCY AND DEVELOPMENT OF
MORE COMMON CANCERS AND
SOCIOLOGICAL CULTURAL FACTORS
AND ACCESS TO CARE BARRIERS,
THAT INCREASE--THAT CONTRIBUTE
TO INCREASED RISK AND POOR
OUTCOMES FOR BOTH DISEASES.
WHEN A PERSON WITH HIV IS
DIAGNOSED WITH CANCER, THERE IS
A POWERFUL AND COMBINED IMPACT
ON THE PATIENT, INCLUDING POOR
CANCER SURVIVAL AND INCREASED
CANCER MORTALITY RATES.
THESE OUTCOMES RESULT FROM A
COMBINATION OF PATIENT PROVIDER
AND SYSTEM LEVEL FACTORS SUCH AS
CO-MORBIDITIES,
IMMUNOSUPPRESSION, TREATMENT AND
SURVIVORSHIP DISPARITIES,
PROVIDER DISCRIMINATION AND POOR
CARE ACCORD NATION AND THE
CUMULATIVE BURDEN OF COPING WITH
AND MANAGING BOTH DISEASES.
AS POIGNANTLY STATED IN OUR
RECENT ONCOLOGY ARTICLE, THE
PRESENCE OF LIVING WITH BOALGT
HIV AND CANCER IS DISTINCT FROM
THE EXPERIENCE OF LIVING WITH
HIV OR CANCER.
AND IMPORTANTLY, EMBEDDED WITHIN
THE DISTINCT EXPERIENCE OF A
DUAL DIAGNOSIS OF CANCER AND
HIV, IS THE POWERFUL SOCIAL
PHENOMENON OF STIGMA.
STIGNAIS AN ATTRIBUTE OR
CHARACTERISTIC SUCH AS BEING
DIAGNOSED WITH CANCER OR HIV,
THAT IS DEEPLY DISCREDITING,
LEADING TO BLAME, DISCRIMINATION
AND REYEKS AMONG OTHER NEGATIVE
CONS QUENSS.
TIGER DATABASE MA IS MULTILEVEL
IN NATURE AND CAN BE FELT OR
INTERNALIZED BY THE INDIVIDUAL
WHO IS BEING STIGMATIZED AND
ACTED BY OTHERS SUCH AS
DISCRIMINATION, EMBEDDED WITHIN
SYSTEMS AND STRUCTURES RESULTING
IN DESPERATE TREATMENT.
STIGMA IS ALSO MULTIDIMENSIONAL.
FOR EXAMPLE, STIGMA MAY BE
HEIGHTENED WHEN AN INDIVIDUAL IS
PERCEIVED AS RESPONSIBLE FOR
THEIR HEALTH CONDITION DUE TO
RISKY SEXUAL BEHAVIORS OR
TOBACCO USE, OR THE DECS
PERCEIVED AS CONTAGIOUS, OR THE
DISEASE IS VISIBLE TO OTHERS,
SUCH AS CARPOSI'S SARCOMA OR THE
SIDE EEIVETS OF CANCER
TREATMENT, THIS R, IFA FOCUSES
ON INDIVIDUALS WITH A DUAL
DIAGNOSE OF HIV AND CANCER AS
THEY HAVE AN INCREASE RISK OF
NEGATIVE CANCER OUTCOMES GIVEN
THEY EXPERIENCE TIGER DATABASE
MA SOCIALITIED WITH BOTH HEALTH
ATTRIBUTES.
TRADITIONALLY HIV STIGMA AND
CANCER TIGER DATABASE MA HAVE
BEEN STUDIED INDEPENDENTLY.
OVER THE LAST 4 YEARS THERE'S
BEEN A SIGNIFICANT EVIDENT BASE
ESTABLISHED REGARDING THE NEG5
EFFECTS OF HIV TIGER DATABASE MA
AND THERE'S A GROWING FIELD OF
RESEARCH ON THE NEGATIVE IMPACTS
ASSOCIATE WIDE CANCER STIGMA.
A FEW EXAMPLES OF THE NEG5
EFFECTS OF EACH STIGMA ARE
HIGHLIGHTED ON THE CURRENT SLIDE
HOWEVER, THERE IS LIMITED
RESEARCH ON THE CONFLUENCE OF
THE 2 STIGMAS WITH PEOPLE WITH
HIV AND CANCER.
WE KNOW FROM THE BROADER
LITERATURE THAT STIGMAS ARE NOT
ADDITIVE OR RATHER INTERACTIVE
AND LIKELY SUCH THAT THE
COMBINATION OF HIV STIGMA AND
CANCER TIGER DATABASE MA HAS A
POWERFUL IMPACT THAT GOES WELL
BEYOND THE EFFECT OF EITHER
ALONE.
CANCER OUTCOMES HYPOTH SIZE TO
BE NEGATIVELYEC AFFECTED BY THE
CONVERGENCE OF CANCER TIGER
DATABASE MA AND IPT GREATER
CREASE ACCESS HEALTHCARE
UTILIZATION, INITIATION AND
COMPLETION OF CANCER GUIDELINE
TREATMENT, PARTICIPATION IN
CLINICAL TRIALS, QUALITY OF LIFE
AND PSYCHOSOCIAL WELL BEING, AND
THE ENGAGEMENT AND HEALTHY
BEHAVIORS SUCH AS TOBACCO
CESSATION, SCREENING FOR
SECONDARY CANCERS AND MONITORING
RISK OF RECURRENCE AMONG OTHER
OUTCOMES.
MORE RESEARCH IS NEEDED TO
UNDERSTAND AND ADDRESS THE
COMBINED IMPACT OF BOTH STIGMAS
ON PEOPLE WITH HIV AND CANCER,
PARTICULARLY GIVEN THE DIVERSE
SOCIOLOGICAL CULTURAL AND
HEALTHCARE CONTEXT HERE IN THE
U.S. AND AROUND THE WORLD.
AS SUCH THE GOALS OF AN RFA WILL
BE TO EXPAND THE CURRENT
UNDERSTANDING OF THE CONVERGENCE
OF CANCER STIGMA AND HIV STIGMA
AMONG HIV IN PEOPLE WITH CANCER
AND ASSESS THE IMPACT OF THESE
DUAL STIGMAS ON CANCER OUTCOMES,
LEVERAGE STIGMA REDUCTION
INTERVENTIONS AT MULTIPLE LEVELS
TO INTERVENE ON MECHANISMS OF
STIGMA AND PROMOTE RESEARCH AND
DIVERSE DOMESTIC AND
INTERNATIONAL CONTESTS, EXAMPLE
RESEARCH TOPICS RESPONSIVE TO
THIS RFA INCLUDE LONGITUDINAL
STUDIES TO ASSESS THE IMPACT OF
CANCER STIGMA AND HIV STIGMA ON
CANCER OUTCOMES AND STUDIES THAT
INVESTIGATOR FACTORS THAT EITHER
EXACERBATE OR MITIGATE THE
ASSOCIATION OF THE DUAL STIGMAS
WITH CANCER OUTCOMES AND STUDIES
THAT DEVELOP AND EVALUATE STIGMA
REDUCTION INTERVENTIONS
IMPLEMENTED AT INDIVIDUAL,
PROVIDER, COMMUNITY AND/OR
STRUCTURAL LEVELS TO IMPROVE
CANCER OUTCOMES IN PEOPLE WITH
HIV CANCER.
TO DEDICATED RFAs WOULD DEMON
TRAIT THIS HIGH PRIORITY
RESEARCH AREA AS WELL AS SUPPORT
A BOLUS OF TRANSDISCIPLINARY
RESEARCH PROGECS LED BY DOMESTIC
AND INTERNATIONAL INVESTIGATIVE
TEAMS.
WE ARE PROPOSING TO FIND 5-6
RO-1S AND 3 R21S FOR A TOTAL OF
6 MILLION IN YORE 1 AND
27 MILLION OVER THE 5 YEAR
INITIATIVE.
WE MET WITH OUR BSA REVIEWERS
LAST WEEK TO DISCUSS THEIR
INSIGHTFUL FEEDBACKOT FUNDING
CONACCEPT ANDsA RAY SUMMIT WE
HAVE FURTHER CLARIFIED SEVERAL
IMPORTANT POINTS.
REGARDING SCOPE, WE ARE ASKING
INVESTIGATORS TO FOCUS ON THE
AACTUALITY POPULATION AS THE
DUAL STIGMA EXPERIENCE AND
MECHANISMS ARE LIKELY TO DIFFER
SUBSTANTIALLY BETWEEN ARK DULT
ANDS CHILDREN, AND WE ARE HOPING
THE INVESTIGATORS WILL CONSIDER
THOSE WITH ONCOGENIC VIRUSES,
BEHAVIORIAL RISK FACTORS, CANC
XER AGING AND OTHER SOCIOLOGICAL
CULTURAL FACTORS THAT ARE MORE
RELEVANT TO AN ADULT PATIENT
POPULATION.
ENEMY ARK DITION THE RFANATICA
WILL PROMOTE CONSIDERATION OF
ALL CANCER SITES AS WE WANT
INVESTIGATORS TO EXPLORE THE
DUAL STIGMA EXPERIENCE BASED ON
DIFFERENT COMBINATIONS OF HIV
AND CANCER DIAGNOSIS.
FOR EXAMPLE, THE HIV AND
PROSTATE CANCER EXPERIENCE IS
LIKELY VERY DIFFERENT THAN HIV
IN CARPOSI SARCOMA OR HIV IN
LUNG CANCER COMPARED TO HIV AND
CERVICAL CANCER AND THESE
EXPERIENCES ARE ALSO DEPENDENTOT
DOMESTIC OR INTERNATIONAL TODAY
SETTING INCLUDING CULTURAL
BELIEFS AND SOCIAL ANDIENDER
NORMS AND THE GEOGRAPHIC AREAS
INCIDENCE PREVALENCE OR
MORTALITY RELATED TO HIV AND
CANCER WHICH THE INVESTIGATORS
ARE ASKED TO CAREFULLY CONSIDER
AND JUSTIFY.
GIVEN THE PREMISE OF THE RFA
CONCEPT, AMONG DUAL STIGMAS WITH
PEOPLE WITH HIV AND CANCER, IN
ADDITION APPLICATION SHOULD
CONSIDER THE INTERSECTION OF
OTHER RELEVANT IDENTITY BASED
STIGMAS THAT ARE EXPERIENCED BY
INDIVIDUALS OF DIFFERENT RACES
AND ETHNICITIES, SOCIOECONOMIC
STATUS, OCCUPATIONS AND SEXUAL
AND GENDER IDENTITIES AS
APPROPRIATE.
CANCER OUTCOMES ARE PRIMARY
INTEREST AND WILL BE REQUIRED BY
THE RFA, HOWEVER APPLICATIONS
MAY ALSO ENCLUED HIV OUTCOMES.
LASTLY, TO INSURE ROBUST
RESPONSE TO THE RFA, WE WILL
DEVELOP AND IMPLEMENT A
COMMUNICATION PLAN WITH OUR NIH
AND NCI COLLEAGUES THAT IS
DESIGNED TO REACH DOMESTIC AND
INTERNATIONALLY HIV AND CANCER
RESEARCH AND ADVOCACY
COMMUNITIES AND PROMOTE
TRANSDISCIPLINE ANNIE
APPLICATIONS.
WE WILL ALSO PUBLISH THE NOTICE
IN THE NIH GUIDE AND AS WELL AS
HOST A PREAPPLICATION WEBINAR.
THANK YOU FOR THE OPPORTUNITY TO
PRESENT THIS RFOOTWORKA COB
SEPTORS AND I LOOK FORWARD TO
YOUR QUESTIONS NROBIN THAT WAS
AN EXEMPLARY AND VERY SHORT AND
WONDERFUL PRESENTATION, THANK
YOU.
LET'S HEAR FROM THE CHAIR OF THE
COMMITTEE.
>> WELL, YOU TOOK AWAY MY SAILS
SO THAT WAS BASICALLY MY
RESPONSE TO THE MING AND
APPRECIATE ALL THE CHANGES
MODIFICATIONS YOU MADE 3 OR 4
SIDED CHANCE TO MEET WITH THIS
TEAM DEVELOPING IN RFA WERE
ENTHUSIASTIC ABOUT IT AND THE
AREA OF THAT INTERSECTION
BETWEEN 1 POINT OF CLARITY WEAN
PEOPLE WITH CANCER AND WITH HIV,
IS 1 THAT UNDEREXPLORERS CAN
AFFECT THE ACCESS AND OUTCOMES
OF CARE MOST OF IF NOT ALL OF
THE QUESTIONS WERE RAISED EXOFF
THIVELY SO I'M NOT SURE I HAVE
MUCH MORE TO ADD TO IT, I THINK
STILL THE POINTS BEING MADE ARE
CLARIFYING MORE WHEN TALKING
ABOUT CANCER OUTCOMES, WHAT THAT
IS EXPLAINED TO BE, RIGHT IN
BECAUSE CANCER OUTCOMES, WILL
STILL MEAN TREATMENT OUTCOMES,
SO CANCER MORTALITY AND SURVIVAL
OUTCOMES AND I THINK SOME OF
THAT CLARITY MAY BE HELPFUL TO
THOSE WHO ARE TRYING TO CLARIFY
AND THE COURSE OF THE
PREAPPLICATION WEBINAR PROCESS.
BUT I'M EXCITED ABOUT IT BECAUSE
IT'S AN AREA REALLY IMPORTANT
AREA, THE ISSUES OF ORIGIN
STIGMA MA WHICH IS THE CAUSE OF
THE DISEASE AND YOU VERSUS FOR
IT VERSUS SOMEONE WHO MAY NOT
HAVE THE PERSISTENCE OF
RESPONSIBILITY COULD BE AN
ISSUE.
SO I AM GOING TO GIVE IT OVER TO
ANDY AND JEN TO GIVE THEIR
THOUGHTS.
>> YEAH, THAT WAS AN EXCELLENT
PRESENTATION AND I REALLY
APPRECIATED THE INCORPORATION OF
THE FEEDBACK, I THINK IT'S A
REALLY IMPORTANT AREA AND I
PARTICULARLY THINK IT'S
IMPORTANT TO KIND OF ALSO
CONSIDER THE OTHER SOURCES OF
SIGMA ON HAVING THIS DISEASE
WHICH IS AN IMPORTANT ROLE AND I
THINK THAT WILL BE A KEY THING
FOR APPLICANTS TO HOPEFULLY
ADDRESS EMPLOY NAGAIN, THAIRNG
YOU FOR THE EXCELLENT
PRESENTATION LAST WEEK AND THIS
WEEK AND THANK YOU FOR
ADDRESSING THE PEDIATRIC
POPULATION AND THE GEOGRAPHIC
DISTRIBUTION OF THIS AND YOU'RE
RIGHT, IT'S NOT [INDISCERNIBLE],
1 PLACE HERE IS NOT 1, IT'S 1
PLACE AND LIKELY 4 OR 5 SO 1
QUICK QUESTION YOU HAD ANSWERED
LAST WEEK BUT FOR THE BIGGER
GROUP HERE IS THE INTERVENTIONS
ARE THEY GOING TO BE BEHAVIORIAL
OR THERAPEUTIC OR BOTH?
>> BEHAVIORIAL.
BEHAVIORIAL ALONG WITH OTHER
OPPORTUNITIES, YOU KNOW I THINK
YOU CAN INTERVENTION WITH THE
INDIVIDUALS AND AMONG PROVIDERS
AND EVEN WITHIN A HEALTHCARE
SYSTEM SETTING AS WELL AND
COMMUNITY SETTINGS BUT ALSO
THINKING ABOUT HOW WE CAN
USE--THERE'S ACTUALLY A STUDY
WITH CAPOSI'S SARCOMA PATIENTS
DIAGNOSED WITH HIV WERE ACTUALLY
MAKING SURE THAT RECEIVED THEIR
CANCER TREATMENT WAS A STIGMA
REDUCTION INTERVENTION BECAUSE
THEN THEY GOT BETTER AND THEIR
CANCER WAS BEING TREATED AND
THAT--SO WELL IS I GUESS IN A
SENSE A MEDICAL INTERVENTION IN
THAT POINT OF DELIVERING THEIR
ACTUAL CANCER, RECOMMENDED
CANCER CARE BUT THE SCOPE OF
THESE WOULD OBVIOUSLY FALL
WITHIN BEHAVIORIAL AND
COMMUNICATION ORIENTED
INTERVENTIONS.
NARE THERE ANY OTHER SALIENT
COMMENTS?
YES IN.
>> THANK YOU SO MUCH ROBIN.
GOOD TO SEE YOU, WONDERFUL
PRESENTATION AND I WAS VERY
STRUCK BY THE DEFINITION OF
STIGMA BECAUSE I DON'T KNOW I'VE
EVER THOUGHT ABOUT IT THAT WAY
SO I'M TBLAD YOU TALKED ABOUT
IRPT SECTIONALLITY BECAUSE
STIGMA BEING BE BLACK SKIN, IT
COULD BE IMMIGRATION STATUS OR
INCARCERATION STATUS SO THERE
COULD BE ALL OF THOSE SO TEASING
OUT THE INTERSECTIONALITY WILL
BE REALLY INTERESTING TO SEE
WHAT TECHNIQUES ARE USED FOR
THAT AND THEN JUST FOR
CLARIFICATION, DO YOU KNOW WHAT
THE PREVALENCE OF CANCER IS IN
INDIVIDUALS WITH HIV BOTH IN THE
U.S. AND THEN MORE BROADLY?
>> GREAT QUESTION.
IN THE UNITED STATES FOR 2020
THERE ARE ESTIMATED ABOUT 8000
CASES OF HIV AND CANCER AND
WHAT'S BEEN INTERESTING ABOUT
THE PATTERN OF CANCER AND HIV IN
THE U.S., FOR EXAMPLE IN 2010
THE LEADING CAUSES WERE
CARPOSI'S SARCOMA AND
NONHODGKINS LYMPHOMA BUT 2030 IT
WILL TRANSITION TO PROSTATE,
LUNG AND LIVER WHICH GOES BACK
ALSO TO THE CANCER IN AGING AND
LONGER LIFE EXPECTANCY SO
THERE'S DIFFERENT PATTERNS
WITHIN THE UNITED STATES AND
THEN IF YOU GO GLOBALLY TO YOUR
NEXT PART OFIOURE QUESTION, THAT
IS A LITTLE BIT MORE OF A
CHALLENGE TO COME UP WITH GLOBAL
ESTIMATES DUE TO CANCER
SURVEILLANCE CHALLENGES,
HOWEVER, WE DO FOR EXAMPLE, WITH
SERVAL CANCER AND HIV, CAN
OCCURRENCE AND AS WELL AS
CARPOSI'S SARCOMA IN HIV,
PREVALENCE, IT'S PRIMARILY
CONCENTRATE INDEED EASTERN AND
SOUTHERN AFRICA, BUT THERE ARE
ALSO OTHER, YOU KNOW WHAT I
MIGHT ELEVATED REAMIONS FOR
EXAMPLE, IN SOUTHEAST ASIA, WITH
CANCER AND HIV.
>> OTHER COMMENTS?
HERE, HERE, AND THERE?
QUICKLY.
>> SO THANK YOU FOR THE
PRESENTATION.
I'M WONDERING IF THE--I'M
CONFUSED SO HELP ME CLARIFY, I'M
WONDERING IF THE OPPORTUNITY
HERE IS AND THE PLAN IS THORS
ALSO, YOU MENTIONED THAT YOU'RE
PLANNING TO UNDERSTAND THE
SOURCES OF STIGMA, AND ALSO
GOING TO UNDERSTAND THE SOURCES
INDEPENDENT OF STIGMA, THAT ARE
RELEVANT TO THE POOR OUTCOMES IN
THIS POPULATION, SO I'M THINKING
FOR INSTANCE, WELL THE
UNDERLYING PROBLEM I HAVE IS
THAT HIV, JUST ANY DIAGNOSIS OF
HIV PAST OR PRESENT OFTEN
REMAINS AN EXCLUSION CRITERIA IN
THE INDUSTRY TRIALS AND NOT SO
MUCH IN NKRRK I TRIALS BUT IN
TREY TRIAL ANDS I THINK A LOT OF
HA IS A MISUNDERSTANDING OF WHAT
THE PROGNOSTIC OUTCOMES ARE AND
HOW TO BEST UNDERSTAND THESE.
AND LIKE FOR LYMPHOMAS IS IT
BECAUSE FOR EXAMPLE, IT'S
THEY'RE DIAGNOSED LATER IN TERMS
OF GETTING CLINICAL CARE,
GETTING THE DIAGNOSIS AND YOU
HAVE HIGHER BURDEN OF DISEASE,
HIGH BURDEN OF DEC DOESN'T WORK
SO WELL WITH CELL THERAPIES FOR
LYMPHOMA, SO IT'S NOT REALLY THE
HIV, IT'S THE HIGH BURDEN OF
DISEASE EMPLOY THAT'S THE KIND
OF THING I'M TALKING ABOUT, WE
REALLY UNDERSTAND THE CO FACTORS
THAT ARE RELEVANT AND DIFFERENT
THAN THE STIGMA, IT MAY BE
INFORMATIVE TO ALLOW MORE
PATIENTS IN TO INDUSTRY TRIALS.
NWE WILL NEED TO MOVE ALONG
MORE.
QUESTIONS COMMENTS?
NROBIN, GREAT PRESENT ATION, YOU
MENTIONED IF THIS MOVES FORWARD,
THE POTENTIAL SORT OF
RECRUITMENT, YOU KNOW PEOPLE WHO
WOULD BE INTEREST AND I JUST--IT
STRUCK ME THE TIMING IS GREAT,
BECAUSE OF ALL THE SUPPLEMENTS
THAT NCI HAS DONE AROUND THIS
TOPIC, THE D40S FOR
INTERNATIONALLY, AND SO, I JUST
WANT TO MAKE SURE THAT YOU KNOW
YOU PROBABLY GOT THAT ON YOUR
LIST BUT THERE'S REALLY A NICE
CADRE OF PEOPLE WHO WOULD BE
WELL POSITIONED, BUT MAYBE
10IERS AGO THAT WASN'T THE CASE
NABSOLUTELY.
WE THANK YOU TO CGH FOR OFFERING
THOSE ADMINISTRATIVE SUPLEMS FOR
2 FISCAL YEARS.
WE ALSO HOSTED A GLOBAL CANCER
STIGMA CONFERENCE IN NOVEMBER OF
2022 WITH OVER A HUNDRED FOLKS
FROM AROUND THE WORLD.
AND WE ALSO HAVE BEEN IN CONTACT
OBVIOUSLY WITH OUR FOGARTY
COLLEAGUES AND OUR NIMH
COLLEAGUES WHO WORK IN THE HIV
SPACE AS WELL.
SO WE REALLY ARE WELL POISED TO
PROMOTE THIS OPPORTUNITY.
>> CAN I HAVE A MOTION?
SECOND.
>> SECOND.
>> IS THERE ANY FURTHER
DISCUSSION?
IF NOT, ARE THERE ANY NAY VOTES?
ARE THERE ANY ABSTENTIONS?
AUTOUNANIMOUS, OKAY, THANK YOU
VERY MUCH ROBIN.
NOW WE WILL MOVE ON TO THE NEXT
CONCEPT WHICH IS SCALING UP AND
MAINTAINING EVIDENT BASED
INTERVENTIONS TO MAXIMIZE IMPACT
ON CANCER CONCEPT SUMMIT.
DR. DAVID CHAMBERS.
>> YES, GREAT.
THIS IS STILL ON, DIDN'T FALL
ARK SLEEP.
AND OUR COMMITTEE IS FLORRIA,
MARK AND LISA.
PLEASE GO AHEAD?
SO GOOD AFTERNOON, EVERYBODY I'M
VERY PLEASED TO BE ABLE TO
REPRESENT THIS SUMMIT RFA, 1 OF
MY ACRONYMS, SUMMIT IS ON BEHALF
OF THE WONDERFUL DCCPS TEAM, THE
GOALS OF THIS INITIATIVE ARE 3
FOLD, WHAT WE WANT TO DO IS TRY
AND BUILD A KNOWLEDGE BASE FOR
HOW WE BRING EVIDENT BASED
CANCER INTERVENTIONS TO SCALE,
AND MAKE SURE THAT THEY'RE
SUSTAINED, THEIR WIDE SPREAD USE
IS SUSTAINED OVER TIME AT THE
SAME TIME WE WANT TO DIRECTLY
IMPACT STANDARD OF CARE FOR 2
TOBACCO RELATED AREAS WHERE WE
KNOW REDUCED UPTAKE CAN REDUCE
MORTALITY AND WE WANT TO EXTEND
THIS GENERALIZABLE KNOWLEDGE TO
SCALE UP AND SUSTAIN OTHER TYPES
OF INTERVENTIONS EMPLOY AND
SCIENCES AND INFO GRAPHIC COMES
FROM THE PLAN FROM TWEBT 21 AND
REALLY ECHICIZING THAT THE
SCIENTIFIC FOCUS IS TO MAKE SURE
ABOUT HOW WE BRING THESE
INTERVENTIONS TO THE DIFFERENT
CARE SYSTEMS IN WHICH PEOPLE ARE
SEEING TO OPTIMIZE CARE AND SEE
GAINSA THE POPULATION LEVEL IN
SURVIVAL AND QUALITY OF LIFE AND
EQUITY.
AND NOW NOW THROUGH HAD MOON
SHOT AND OTHER INITTIAIVE ITS WE
HAVE BEEN ABLE TO BUILD THE
FIELD IN CAPACITY AND CANCER
CONTROL INTERVENTION AREAS THAT
WE FEEL GET US READY TO TRY TO
REACH THE SUMMIT, TO THINK ABOUT
HOW WE CAN SCALE UP AND SUSTAIN
THESE INTERVENTIONS AT A MUCH
LARGER DEGREE.
SO THERE ARE MANY AREAS IN WHICH
WE CAN ENVISION THE NEED FOR
SCALE UP AND CONTINUEMENT BUT WE
WANTED TO TART WITH THE MOON
SHOT AND NATIONAL CANCER PLAN
GOALS OF TRYING TO REDUCE
MORTALITY BY 50% OVER 25 YEARS
AND THAT SUGGIESTS TO US THAT
TOBACCO RELATED CARE CONTINUES
TO PROVIDE EXAMPLES WHERE SCALE
UP AND SUSTAINMENT CAN TRANSLATE
BO THOSE REDUCTIONS IN MORTALITY
AND ON THE LEFT YOU SEE LUNG
CANCER SCREENING AND YOU SEE THE
TASK FORCE RECOMMENDATION AND
YET WE KNOW THAT UPTAKE MAY BE
AS LITTLE AS 4 PERCENT OR UP TO
28%, THERE WAS A PAPER UP TO 2
YEARS AGO THAT ESTIMATE THE
LEVEL OF UPTAKE AT 22 FROM THE
POPULATION, FROM OUR MODELERS WE
KNOW WE CAN SAVE THOUSANDS OF
LIVES IF WE CAN DRAMATICALLY
INCREASE KREENING RATES, IT
SEEMS LIKE SOMETHING WE NEED TO
SCALE UP AND SUSTAIN AS SOON AS
WE CAN.
WE ALSO HAVE EVIDENCE-BASED
INNERVENTIONS FOR TOBACCO
CESSATION, TOBACCO USE TREATMENT
AMONG CANCER SURVIVORS, SOME
FACT WOE HAD A MOON SHOT INIT
WHYATIVE, WHERE OVER 50
DIFFERENT EXAMPLES OF TRYING TO
LOCALLY IMPLEMENT EVIDENT BASED
TOBACCO USE TREATMENT FOR CANCER
PATIENTS WERE ATTEMPTED.
AT THE SAME TIME WE KNOW THERE'S
2 MILLION PEOPLE AT LEAST WHO
ARE SMOKERS AND WE KNOW THAT
SMOKING FOR THOSE WHO HAVE BEEN
DIAGNOSED AND ARE RECEIVING
TREATMENT FOR CANCER IS REDUCING
SURVIVAL AND SO AGAIN AN AREA
WHERE WE ARE RELATIVELY LOW
UPTAKE, IT'S NOT A STANDARD PART
OF CARE THAT WE BELIEVE THAT IT
CAN BE AND SO SCALE UP AND
CONTINUEMENT TRIALS COULD BE
INKRED BELIEVELY HELPFUL SO THE
SUMMIT STRUCTURE MAPS ON TO
THOSE 2 CHALLENGES, 2 DIFFERENT
RFAs, BOTH OF WHICH ARE REALLY
CONCENTRATING ON SYSTEM LEVEL
TRAT EDGYS TO KALE UP AND
SUSTAIN THESE RESPECTIVE
INTERVENTIONS WITHIN HEALTHCARE
CLINICS, WE SEE IMRAIT
OPPORTUNITY FOR COLLABORATION
ACROSS THE STUDIES, GIVEN THEY
SHARE RESEARCH QUESTIONS, TYPES
OF SETTINGS AND THE STRATEGIES
THAT CAN SUPPORT SCALE UP AND
SUSTAINMENT AND WE'VE TAKEN THE
APPROACH TO COORDINATION FROM
SOME OF THE OTHER INITIATIVES
THAT WE'VE BEEN ENGAGED IN, THE
IDEA OF A STEERING COMMITTEE AND
SOMATIC WORKING GROUPS.
WE ANTICIPATE COORDINATION
AROUND COMMON MEASURES, RESEARCH
DESIGNS, POOLING DATA ELEMENTS
THAT MIGHT PERMIT CROSS TRIAL
ANALYSIS, WE SEE ACTING AS THE
SHERPA, AND WE'VE INN ENGAGED IN
THE RAGMATIC TRIALS LABORATORY
THAT OVERSEES A LOT OF PRAGMATIC
TRIAL ANDS SYSTEMS AND THEY'RE
MOVING INTO IMPLEMENTATION
SCIENCE AND WE THINK IT'S A
BEAUTIFUL FIT TO HELP TO TAKE
ADVANTAGE OF A LEARNINGS ACROSS
THESE DIFFERENT STUDIES.
SO CONCEPTUALLY YOU WILL SEE THE
CORE OF ALL OF THESE IN THE
MIDDLE.
IT'S THE TYPE OF SUPPORTING KALE
AND SUSTAINMENT, AND THE KINDS
OF STRATEGIES WE THINK WOULD BE
RIGHT FOR TESTING, THE SEE THEA
THE BOTTOM THE TYPES OF SETTINGS
WE LIKE TO SEE THESE TRIALS
LOCATED IN A MINIMUM NUMBER OF
60 SITES PER TRIAL WHICH SOME
MAY THINK ARE AMBITIOUS BUT
THAT'S THE WAY WE BELIEVE WE CAN
GET TO POPULATION LEVEL IMPACT,
THAT THAT NUMBER OF SITES
TRANSLATES INTO THOUSANDS OF
PATIENTS THAT WE CAN WORK WITH,
WITH THIS IDEA THAT EQUITABLE
IMPLEMENTATION IS THE SUCCESS
THAT WE WANT TO HAVE.
THREE TRIALS WE WANT ANTICIPATE
HOPEFULLY BEING ABLE TO SUPPORT
FOR EACH OF THESE RFAs.
SO JUST TO GIVE YOU AN EXAMPLE
OF THE STUDY, WE CAN ENVISION A
RESPONSE SAY TO THE LUNG CANCER
SCREENING RFA, PROPOSING A
CLUSTER RANDOMIZED CONTROL TRIAL
ACROSS A HELPED FEDERALLY
QUALIFIED HEALTH CENTER CLINICS,
CAN YOU IMAGINE THE TRIAL DOING
A COMPARATIVE EFFECT OF THE
STUDY OF DEFINITE APPROACHES, 1
MIGHT BE A CLINIC CENTRIC
PRACTICE FACILITATION MODEL AS
WELL AS FOCUSING ON FINANCING OF
THE 8 DIFFERENT COMPONENTS OF
EVIDENCE BASED LUNG CANCER
KREENING, YOU MIGHT COMPARE THAT
WITH A COMMUNITY OF PRACTICE
SCALING UP SITES, AND IT
MENTIONED BEFORE PROJECT OAK E
AND OTHERS THOAT MIGHT BE
HELPFULFUL TO DEVELOP EVIDENT AS
HOW THEY DEVELOP SCALE UP AND
SUSTAINMENT, THE OUTCOME IS
WHETHER THEY GET TO CARE AND NOT
JUST INITIALLY BUT WHETHER
THATTHODE IMPROVED OVER TIME AND
THAT'S WHY YOU CAN SEE FOR
EXAMPLE, THE 12, 18 AND 24 MONTH
OUTCOMES.
SO WE PROPOSE TO FOLLOW UP PAST
INITCRATIVES THAT WE'VE DONE
THAT HAVE DONE THIS UHG3
MECHANISM, WE HAVE DONE THIS IN
COMMON FUND AND MOON SHOT
INITTIAIVE ITS, IT WOULD OFFER 2
YEARS TO SUPPORT THE PREPATTORY
ACTIVITIES FOR EACH OF THE
TRIALS AND CLEAR MILE TONES TO
DETERMINE WHETHER AND NOT A FATE
COMPLETE, WHETHER THESE TRIALS
ARE FEASIBLE TO COMPLETE MOVING
FORWARD AND NCI ADMINISTRATIVE
REVIEW TO DETERMINE HAVE THEY
MET THOSE BENCHMARKS, ARE THEY
READY TO BE LAUNCHED IN DO THEY
HAVE THE SITES AVAILABLE TO
CONDUCT THE TODAY AND ONLY THEN
WOULD MAY HIEWF ON TO THE UH
IMPLEMENTATION 3 PHASE, TO
CONDUCT THE TRIAL.
SO THE PROPOSED BUDGET MAPS ON
TO THE FACES, YOU SEE A SMALLER
FOCUS FOR THE UG FACE IN TERMS
OF OVERALL BUNLET WITH
ANTICIPATED SUPPORT FROM
REMAINING MOON SHOT DOLLARS TO
FUND THE BALANCE OF THIS
RESEARCH PROGECS.
THE UH 3 PHASE, THE BUNLET PER
YEAR MAPS RELATIVELY CLOSER TO
STYLES, AND NOT ALL PROJECTS
WILL GRADUATE TO THE UH3, SO
THIS MAY BE AN OVERESTIMATE OF
THE OVERALL PLAN OR BUDGET WITH
THE INITIATIVE BUT FOR THOSE 4
YEARS THOSE PRONG ECTOMYOSINS
THAT ARE DEEMED ABLE TO MOVE
FORWARD WOULD DO SO SO IN THE
SHORT-TERM, THE EVALUATION
CRITERIA, THE WAY WE MEASURE
SUCCESS REEL KEEPSAKESLY RELATED
TO THE DIFFERENT PHASES ARE WE
SEEING IN THE FITTER COUPLE
YEARS THE ACHEFMENT OF THE
MILESTONES.
ARE THEY COMPLOATING PREPATTORY
ACTIVITIES?
ARE THEY ENGAGE NOTHING AROUND
RESEARCH DEFINEMENT IN AROUND
COMMON MEASURES AND METRICS?
ARE THEY ACHIEVING THOSE AND IT
MAPS BACK TO THE PURPOSE, ARE WE
SEEING A GENERATED EVIDENT BASE
FOR HOW WE SCALE UP ON THESE
INTERVENTIONS, ARE WE SEEING THE
KNOCK ON BENEFIT IN TERPS OF
INCREASE OF THE USE OF DIFFERENT
ISHT VENTIONS OVER DISPIEM ARE
WE SEEING THIS CROSS LEARN XG
DOES IT EXTEND POTENTIALLY TO
OTHER AREAS WHERE WE KALE UP AND
DO EVIDENCE BASED CARE.
GREAT FEEDBACK AND CONVERSATION
WE HAD WITH OUR SUBCOMMITTEE BUT
THEY ENCOURAGED US TO MAKE SURE
THAT 60 SITES AS A THRESHOLD
DIDN'T MEAN THAT ONLY CERTAIN
SITES CAN PARTICIPATE, IT ONLY
FAVORS CERTAIN TYPES OF HELT
SYSTEMS AND WE NOTE THAT THE 2
YEAR UG3 PHASE IS INTENDED TO
SUPPORT BROADER SITE RECRUITMENT
AND THE LINK TO THE
COLLABORATORY, THE LINK TO
LEVERAGE SOME OF OUR EXISTS
NETWORKS WE THINK WILL MAKE IT
POSSIBLE FOR MORE SITES TO
PARTICIPATE, IT ENCOURAGES US TO
THINK EFFECTIVELY, WE MIGHT
MODEL WHAT WE'VE DONE IN OUR
IMPLEMENTATION SCIENCE CENTERS
AND CANCER CONTROL WHEN WE'VE
DONE THESE COLLABORATIVE
PROAJTS,A ROUND HEALTH EQUITY
AND WE MIGHT DO THINGS AROUND
SUPPLEMENTS AND USING
INFRASTRUCTURES AND WANTED TO
MAKE SURE WE DO USE THE
OPPORTUNITY TO INN COURAGE
MULTIPI GRANTS ACROSS
INSTITUTIONS, AT THE SAME TIME
WE DON'T WANT TO SEE ALL OF THE
PROGECS LOCATED WITHIN A VERY
SMALL SET OF INSTITUTIONS, SO WE
WANT TO LIMIT THE INSTITUTION
THAT CAN SERVE AS A PRIMARY
GRANT RECIPIENT FOR EACH TRIAL
TO JUST 1 APPLICATION FOR RPFA,
THEY GAVE US GREAT PEDE BACK ON
INCLUDING EARLY STAGE
INVESTIGATORS AND THEN WHILE WE
ARE FOCUSED ON GUIDE LINE
CONCORDANT CARE, THEY DID
ENCOURAGE US TO MAKE SURE THAT
THINKING ABOUT CERTAIN GROUPS
THAT MIGHT BENEFIT FROM THESE
INTERVENTIONS ARE NOT IGNORED
LIKE YOUNG ADULT CAPSER
SURVIVORS AND SAFETY NETSYSTEMS
SO WITH THAT I AM WANT TO SAY I
AM PRIVILEGED TO BE A--BITS TO
WORK WITH THIS INCREDIBLE WHO
DESERVES THE CREDIT FOR THE GOOD
THING ANDS I THANK YOU SO MUCH
FOR LISTENING.
>> THANK YOU.
GLORIA?
>> NICE PRESENTATION AND I WANT
TO ACKNOWLEDGE THE OTHER MEMBERS
ON THE COMMITTEE, LISA AND MARK
AND I WELCOME THEIR CONTRIBUTION
TO THIS DISCUSSION.
OUR COMMITTEE WAS ENTHUSIASTIC
ABOUT THIS RFA, IT WAS
INFOIVATIVE AND HAD THE
POTENTIAL TO ADVANCE THE FIELD
OF IMPLEMENTATION SCIENCE.
I THINK IT'S TRUE TO SAY THAT A
LOT OF IMPLEMENTATION SCIENCE
RESEARCH FOCUSES ON THE
IMPLEMENTATION BUT NOT AS MUCH
ON SCALE UP AND SUSTAINABILITY,
AND SO I THOUGHT THAT WAS A
REALLY NICE WAY TO ADVANCE THE
FIELD.
SO FOCUS ON LUNG CANCER
SCREENING AS WELL AS TOBACCO USE
TREATMENT WAS ALSO THOUGHT THAT
HAVE HIGH IMPACTENTIOUS
SPECIALLY AS IT ALIGNED AROUND
CANCER MORTALITY AND I THINK IT
WAS ALSO THOUGHT THIS PARTICULAR
MECHANISM THAT UG3 AND UH3,
WOULD BE PARTICULARLY
APPROPRIATE FOR THIS TYPE OF
TOPIC BECAUSE IT GIVES NCI A
CHANCE TO REALLY KIND OF HAVE
INFLUENCE AS POTENTIALLY
DISCONTINUE THESE STUDIES THAT
MAY NOT BE MEETING MILESTONES IN
THE FIRST COUPLE OF YEARS.
I THINK THERE WAS DISCUSSION
ABOUT WELL THERE WOULD BE ENOUGH
IN COMMON BETWEEN THE 2
DIFFERENT RFAs AND TOPICS I
THINK YOU CAN SEE FROM THE THEN
DIAGRAM THIS IS ABOUT THE SCALE
UP APPROACH THAT REALLY IS THE
COMMONALITY AND I THINK
TAKEN--THEY WE WERE REASSURED
THAT THERE WOULD BE ENOUGH KIND
OF COMMON SCIENCE THEY CAN MOVE
FORWARD AND I PERSONALLY THINK
IT'S A GREAT IDEA TO KIND OF
LEVERAGE THE EXISTING
INFRASTRUCTURE LIKE THE NIH
COLLABORATORY THAT HAS A REALLY
WELL KNOWN COORDINATING CENTER
AND CONTINUES TO CRANK OUT A LOT
OF PUBLICATIONS EVEN THOUGH I'M
STILL INVOFFED IN PANELS AND
PUBLICATIONS EVEN THOUGH I WAS
FUNDED OVER 5 YEARS AGO.
SO I THINK THAT WILL BE A REALLY
GREAT WAY TO KEENED OF LEVERAGE
SOME OF THE EXISTING
INFRASTRUCTURE AND RESOURCES
THAT EXIST.
AND I WILL DEFER TO MY OTHER
COMMITTEE MEMBERS FOR COMMENT.
>> MARK AND THEN LISA?
>> SURE, I AGREE WITH ALL OF
THOSE COMMENTS AND STRONGLY
SUPPORT THE PROPOSAL.
ONE MY CONCERNS WAS THE 60
CLINIC RULE WHICH IS CHALLENGING
WHEN YOU SAY RANDOMIZED EACH
ARM, QACs TO DO REAL
IMPLEMENTATION CHANGE THAT, KIND
OF MAKES ME BREAK OUT IN A SWEAT
A LITTLE BIT BUT I THINK AS LONG
AS IT'S SET UP IN A WAY THAT WE
CAN ADDRESS THE LAST MILE
INITIATIVE AND GO TO THE KAISER
PERMANENTE, I WOULD SAY WE CAN
DO THAT BUT WE'RE AT THE LESS
RESOURCE SITES IF IT CAN BE SET
UP IN A WAY TO GET THE
STATISTICAL POWER YOU NEED
ACROSS SITES, I THINK THAT'S
GREAT.
>> THANKS.
>> GREAT PRESENTATION AND GREAT
SUMMARY OF OUR DISCUSSIONS, SO I
AM NOT INVOLVED IN THE LUNG
CANCER WORLD AT ALL BUT IN TERPS
OF DISPARITIES, I SAW NICE
OPPORTUNITY FIST ARE THIS WORK
TO ADDRESS CORRELATIVE SCIENCE
RELATED TO SCIENCE DISPARITIES
AND EVEN THOUGH YOU'RE LOOKING
AT KALING UP, IT WOULD BE
WONDERFUL TO SPECIFICALLY ENGAGE
RESEARCHERS TO COLLECT SPECIMENS
THAT CAN LOOK AT GERM LINE
GENETIC ANCESTRY BECAUSE THERE
HAVE BEEN SOME SIGNAL THAT
AFRICAN GERM LINE, GENETIC
AFRICAN ANCESTRY IS ASSOCIATED
WITH SOMETHING THAT INCREASES
SENSITIVITY TO TO BACK O RELATED
LUNG CANCERS, SO IT WOULD BE
NICE TO SEE THAT TYPE OF--THAT
RESEARCH SUPPORTED WITH THESE AS
WELL.
SNRG OTHER DISCUSSION.
>> ONE, 2, 3.
>> THANKS CHRIS FROM MICHIGAN, I
NEED TO DOUBLE DOWN ON MARK'S
COMMENT ABOUT THE 60 SITES AND
I'M READING YOUR REPORT HERE,
THE RATIONAL IS 60 SITES WOULD
BE TWICE THE MEDIAN NUMBER OF
SITES OF THE CURRENT PORTFOLIO
BUT YOU'RE NOT GIVING THEM
DOUBLE THE DIRECT COST BUDGET
PER PROGEC, SO, I THINK THAT'S A
HUGE ISSUE.
I WOULD ASK YOU TO RECONSIDER
THAT AND INSTEAD HAVE THE REVIEW
COMMITTEE CAREFULLY ASSESS THE
DIVERSITY OF THE SITES, THE
ADQUAISY OF THE REPRESENTATION,
THE ACTUAL CAPACITY TO RECRUIT
IN A PHYSICAL LOCATION, IT'S
DIFFERENT ACROSS--YOU MIGHT HAVE
45 SITES ON PAPER AND 25 THAT
ARE DOING THE REAL WORK, SO I
WOULD STRONGLY ENCOURAGE YOU TO
RECONSIDER THAT.
THANKS.
>> OTHERS, YES, 1, 2, PLEASE?
>> NETWORK YEAH, I REALLY
APPLAUD THIS CASE WHERE YOU TAKE
INTERVENTIONS AND DETERMINING
IMPLEMENTATION BUT I WAS REALLY
STRUCK BY DR. PHIL CASTLES
PRESENTATION, THE OTHER NIGHT
AND HE TALKED ABOUT HOW, YOU
KNOW DOING SCREENING IS REALLY
GREAT BUT THEN HAVE YOU SOME
DOWN STREAM NEGATIVE
CONSEQUENCES, MEANING THAT IF
YOU ARE POSITIVE, YOU TEST
POSITIVE ON SOME SCREENINGS THEN
WHAT HAPPENS IN AND I'M
WONDERING IF THAT MITOCHONDRIAL
BE SOMETHING TO CONSIDER--MIGHT
BE SOMETHING TO CONSIDER WHAT
ARE THE UNINTENDED CONSEQUENCES
OF LAUNCHING A LUNG CANCER
SCREENING TAKING THAT INTO
CONSIDERATION, I PROVIDE
IMPORTANT INFORMATION.
THE OTHER IS THAT WHEN YOU'RE
SMOKER IT'S HIGHLY OFFENSIVE ON
CIGARETTES AND/OR TO PACK O
PRODUCT AND I WAS WONDERING IF
THAT'S TAKEN INTO CONSIDERATION
WHEN YOU'RE LAUNCHING AN
INTERVENTION FOR SMOKING
CESSATION, IS THERE ANY KIND OF
INNOVATION THAT WOULD TREAT MORE
HIGHLY DEPENDENT INDIVIDUALS,
MAYBE SOMETHING THAT IS MORE
CULTURALLY TAILORED TO A CANCER
SURVIFFOR SO THAT WOULD BE MORE
INTERESTED IN TAKING UP A
SMOKING CESSATION PROGRAM,
BECAUSE SOMETIMES THAT'S A
CHALLENGE AS WELL, IS THE
INTEREST IN ACTUALLY ENGAGING IN
SMOKING CESSATION, SO, THAT
MIGHT BE SOMETHING TO CONSIDER
AS WELL.
>> YEAH, SO THANKS IF ARE THOSE
COUPLE COMMENTS, JUST TO
CLARIFYOT KREENING PROCESS AND
APPRECIATE THE COMEBTS EARLIER
TODAY AS WELL OF THE IDEA OF
JUST SCREENING AND THEN NOTHING,
NOT BEING THE APPROPRIATE CARE.
SO EVIDENT BASED AT LEAST AS
DEFINED, DOES ENCLOUD THAT
PATHWAY, JUST BEYOND THE INITIAL
SCREEN BECAUSE NOBODY SHOULD GET
STUCK WITH NO CLEAR WAY TO GO
AND SO IT BECOMES A CHALLENGE OF
HOW DO WE MAKE HUR WE SCALE UP
ALL ASPECTS OF THE KREENING
PROCESS, I THINK THE NOTE ABOUT
EVIDENCE BASED CESSATION
SERVICES, AGAIN WITH THIS
INITIATIVE WE'RE TRYING TO
CAPITALIZE ON EXISTS
INTERVENTIONS BUT I THINK IT
DOES GO TO THE INVESTIGATIVE
TEAMS TO NOT JUST THINK ABOUT
THE SUPPLY OF THE INTERVENTIONS
BUT THE DEMAND FOR THEM, AND THE
DIFFERENT APPROACHES TO TRY AND
MAKE SURE THAT THE POPULATION
THAT COULD BENEFIT FROM THEM IS
ENGAGED IN CARE AND SO MANY OF
OUR IMPLEMENTATION STUDIES RISE
OR FALL ON THE ABILITY TO ENGAGE
FOLKS WHO WOULD POTENTIALLY
BENEFIT FROM THOSE INTERVENTIONS
BUT IT'S A GREAT POINT TO MAKE
SURE THAT WE'RE NOT CREATING A
MISMATCH BETWEEN THE
INTERVENTIONS THAT ARE OFFERED
AND THE NEED OR THE PREFERENCE
FOR THEM.
N1 LAST COMMENT FROM RAY?
NDAVE IRD CONGRATULATIONS, VERY
NICE PRESENTITION, AS I SAID
EARLIER, IF WE ARE ANYTHING TO
CHANGE CANCER AS WE KNOW IT,
LUNG CANCER HAS TO BE A HUGE
COMPONENT OF THAT AND EARLY
DETECTION IS PROBABLY A CROWN
JEWEL.
I WILL JUST LET EVERYBODY KNOW
THAT THE NATIONAL LUNG CANCER
ROUND TABLE HAS RECOGNIZED LUNG
CANCER SCREENING, THE GAP IN
LUNG CANCER SCREENING AS AN
IMPLEMENTATION SCIENCE PROBLEM.
SO LAST YEAR AT THE ANNUAL
MEETING OF THE NATIONAL LUNG
CANCER ROUND TABLE WE ACTUALLY
INVITED DAVID TO COME IN AND DO
AN IS PROGRAM IN THIS, JUST
SPEAKS TO THE ENORMITY I THINK
OF THE OPPORTUNITY THAT A
NARRATIVE LIKE THIS WOULD
REPRESENT.
SO CONGRATTULESS FOR BRINGING IN
FORWARD.
THIS, WE NEED TO MOVE PRETTY
QUICKLY.
>> I JUST HAVE A QUICK QUESTION,
SO WE LOOK NATIONAL ON SCREEN
FOR YEARS AS THE WORK TURNS
ASIDE A DOZEN THINGS ABOUT IT
WHETHER OR NOT TO ACTUALLY DO IT
AT ALL OR NOT, EVENTUALLY WE DID
BUT THEN WHEN YOU LOOK AT THIS,
DID YOU CONSIDER THINGS LIKE
FALSE-POSITIVES THAT THE IMPACT
THAT NOT READING THE TECHNOLOGY
APPROPRIATELY COULD BE--HAVE AN
IMPACT AND THEN DID YOU ALSO
LOOK AT THE ECONOMIC IMPACT OF
SCALING, A SCREENING TOOL LIKE
THIS.
FIRST OF ALL I LOVE THE MODEL, I
THINK YOU PICKED 1 THAT'S GOING
TO HAVE TO REQUIRE SOME REAL
STUDY UPFRONT TO INSURE THAT THE
ECONOMIC IMPACT ISN'T SO GREAT
THAT WE LITERALLY MIGHT NOT BE
ABLE TO ABSORB IT.
NCOMMITTEE CHAIR 1 LAST COMMENT.
>> ALL RIGHT, I JUST WANT TO
COMMENT ABOUT THE NUMBER OF
CLINIC SITES THAT WOULD BE
REQUIRED BECAUSE I THINK THAT
COMMENT HAS COME UP A COUPLE
TIMES AND I WANT TO SAY, YOU
KNOW IN THE WORK THAT I'VE DONE,
YOU KNOW OFTEN TIMES CLINICS ARE
ORGANIZED IN CLUSTERS SO YOU
KNOW IN A STUDY I DID, WE WORKED
WITH 8 HEALTH CENTERS THAT
OPERATED 26 CLINICS AND WE'RE
DOING A SCALE UP AS A THIRD AIM
TO OUR MOON SHOT STUDY, THAT'S
INTENDING TO WORK WITH 130
CLINICS AND WE ARE ACTUALLY
EDUCATING ABOUT 40 DIFFERENT
REPRESENTATIVES BECAUSE EACH 1
OF THOSE CENTRALIZED STAFF WORKS
WITH A VARIETY OF CLINICS AND
SO, I ACTUALLY AM NOT AT ALL,
LIKE FROM WHERE I SIT I'M NOT AT
ALL CONCERNED ABOUT THE 60
MINIMUM AND I THINK IT'S A
REALLY NICE WAY TO PUSH THE
FIELD FORWARD AND IN TERPS OF
DOLLAR FOR DOLLAR, LIKE YOU
DON'T SAY 30 IS X-MILLION AND SO
60 SHOULD BE TWICE THAT, BECAUSE
SCALE UP IS ABOUTENTIOUS
FICIENCYS AND SPREADING THINGS
TO THE WORLD ASK IT SHOULDN'T
COST AS MUCH AS THAT INITIAL IMP
REMENTATION.
THE OTHER POINT I WILL TAKE IN
TERMS OF POWER CALCULATIONS IS
THAT IF YOU CAN'T SCALE UP AND
YOU CAN'T SUSTAIN AND SO REALLY
WE NEED TO POWER THE STUDIES ON
THIS SUSTAINABILITY, WITH THE
IDEA THAT NOT EVERY SITE IF IT'S
GOING TO KALE UP IS GOING TO
SUSTAIN THAT IN THE SECOND YEAR.
>> ROOK, INTERESTING DISCUSSION,
CAN WE HAVE A MOTION?
NI MOVE TO,A PROVE.
>> SECOND.
>> OKAY, ANY FURTHER DISCUSSION.
NQUICKLY.
NREALLY QUICK, SO 1 COUPLE OF
POINTS TOBACCO DOCUMENTATION,
AND ADDITION IN PRIMARY CARE, I
SUSPECT THIS WILL NEED TO OCCUR
IS REALLY POOR, SO I THINK
ATTENTION TO HOW THAT IS GOING
TO BE ATTENDED TO ANDIME JUST AS
GUILTY WILL BE IMPORTANT.
SECOND THING IS STIGMA OF
TOBACCO USE NEEDS TO BE TAKEN
INTO ACCOUNT.
THAT'S ALL.
>> ERIN, SOUND BITE.
>> QUICK QUESTION, HOW THIS WILL
INTERACT WITH THE IMPLEMENTATION
SCIENCE CENTERS THAT ALREADY
FUNDED AND HOW YOU PLAN TO
LEVERAGE THAT?
>> CENTERS THAT ARE FUNDED IN
THEIR WANING YEARS HAVE PRACTICE
LABORATORIES SO THEY ALREADY
HAVE NETWORKS OF PARTICULAR
SITES AND THE IDEA IS TO CHIE
TRY TO LEVERAGE THOSE TYPES OF
NETWORKS AND OTHER NETWORKS.
AS FAR AS THE CENTERS IN THE
FIFTH YEAR, 1 CENTER IN THE
FOURTH YEAR, SO THERE'S 1 MIGHT
THINK THAT FOR THOSE THAT WOULD
PROPOSE A TRIAL WHO ARE PART OF
THAT CONSORTIUM IT WOULD BE A
NAIS OPPORTUNITY TO CONTINUE,
BUT IT'S NOT AN ABILITY TO MATCH
IT DIRECTLY TO THAT.
>> THANK YOU.
WE NEED TO VOTE.
>> OKAY.
>> ARE THERE ANY NAYS.
>> WE HAVE A MOTION.
>> I WILL BE 1 NAY.
>> ONE NAY, ANY ABSTENTIONS?
OKAY, THERE'S NOT UNANIMOUS,
THERE'S 1 NAY.
NGOOD.
THANK YOU.
>> THAT WAS TERRIFIC DISCUSSION.
AND A VERY IMPORTANT 1 AND I
WOULD EDITORIALLY SAY IF WE'RE
GOING TO SUSTAIN, WE HAVE TO DO
IT WITH AN EFFICIENT WAY O I
THINK THIS IS VERY INTERESTING.
OKAY, THE NEXT IS SOCIAL
DETERMINANTS OF HEALTH AND
QUALITY OF CARE CONTRIBUTORS TO
CANCER DISPARITIES IN PEOPLE
WITH HIV.
WE'RE GOING TO HAVE A
PRESENTATION FROM REBECCA HUPPI
AND OUR GROUP AND ANN MARIE,
KAREN AND ERIC.
REBECCA?
>> THAIRNG YOU.
FIRST WE WILL LIKE TO THANK
DR. [INDISCERNIBLE], LOPEZ AND
ROBERSTON FOR THEIR HELPFUL
INPUT REKNARREDDING THE CONCEPT.
THE OFFICE OF HIV AND AIDS
MALIGNANCY WITH THE CENTER TO
REDUCE CANCER DISPARITIES IN
COLLABORATION WITH THE CANCER
CONTROL AND POPPULES STUDIES,
DIVISION OF CANCER PREVENTION
AND THE DIVISION OF CANCER
TREATMENT AND DIAGNOSIS IS
PRESENTING THIS PROPOSAL FOR A
NEW RFA ENTITLED SOCIAL
DETERMINE NABTS OF HEALTH AND
QUALITY OF CARE CONTRIBUTORS TO
CANCER DISPARITIES IN PEOPLE
WITH HIV.
SO ROBIN TEED THIS UP QUITE WELL
FOR ME, THERE ARE 1.2 MILL
WHEREON PEOPLE IN THEs, WITH
HIV, WITH 32,000 NEW INFECTIONS
THAT OCCURRED IN 2021, THOSE NEW
INFECTIONS WERE HIGHLY
CONCENTRATED IN 48 COUNTIES, DC
AND SAN JUAN PUERTO RICO, WITH
GREATER THAN 52% OF NEW
INFECTIONS OCCURRING IN THE
SOUTH EMPLOY THIS IS
DEMONSTRATED IN THE HEAT MAP ON
THE RIGHT HAND SIDE OF THE
SLIDE.
CANCER'S BEEN A PROMINENT
MANIFESTATION OF THE HIV/AIDS
EPIDEMIC SINCE THE BEGINNING AND
IS 1 OF THE MOST IF NOT THE MOST
PREQUEPT CAUSE OF DEATH IN
PEOPLE WITH HIV IN THE UNITED
STATES.
PEOPLE WITH HIV WHEN COMPARED TO
THOSE WITHOUT HIV HAVE LOWER
CANCER SCREENING RATES, ARE LESS
LIKELY TO RECEIVE CANCER
TREATMENT HAVE MORE ADVANCED
CANCER DIAGNOSIS AND HIGHER
CANCER MORTALITY.
THERE ARE A NUMBER OF
CONTRIBUTING FACTORS TO THESE
DISPARITIES, THEY CAN BE PATIENT
DRIVEN, PROVIDER DRIVEN AND
HEALTH SYSTEMS RELATED ISSUES.
TO DATE MUCH OF THE WERE AND
SOCIAL DETERMINE NABTS OF HEALTH
AND HIV CARE OUTCOMES SHOWS
ASSOCIATIONS WEAN A SINGLE
FACTOR FOR EXAMPLE, POVERTY AND
CLINICAL OUTCOMES, HOWEVER,
SOCIAL DETERMINANTS OF HEALTH
ARE COMPLEX, INTERSECTING AND
REINFORCING.
SO THERE'S A NEED TO DEVELOP
MULTILEVEL APPROACHES TO BETTER
IMPROVE CANCER PREVENTION AND
COORDINATED CARE IN PEOPLE WITH
HIV.
SO THE PURPOSE OF THE RFA IS TO
EPICREASE THE NCI'S RESEARCH
PORTFOLIO, INVESTIGATING CANCER
DISPARITIES IN PEOPLE WITH HIV.
ALSO TO ADVANCE THE
UNDERSTANDING OF WHICH SOCIAL
DETERMINANTS OF HEALTH ARE
IMPORTANT AND HOW THEY INTERSECT
WITH CANCER CARE INIQUITIES TO
CONTRIBUTE TO DISPARITIES IN THE
PREVENTION, DIAGNOSIS AND
TREATMENT OUTCOMES OF PWITH HIV
AND CANCER WITH AN EXPECTATION
THAT THE RESEARCH MAY INFORM
FUTURE INTERVENTIONS.
NOW POTENTIAL AREAS OF RESEARCH
SCOPE INCLUDE RESEARCH TO BETTER
UNDERSTAND HOW MULTIPLE SOCIAL
DETERMINANTS OF HEALTH INTERACT
AND CONTRIBUTE TO HEALTH
DISPARITIES IN CANCER
PREVENTION, DIAGNOSIS, TREATMENT
AND OUTCOMES IN PEOPLE WITH HIV.
ALSO RESEARCH ILLICITTING HOW
PROVIEDMANNER LEVEL AND SYSTEM
LEVEL FACTORS INFLUENCE THE
QUALITY OF CANCER CARE TO PEOPLE
WITH HIV.
ALSO, RESEARCH IDENTIFYING AND
TESTING STRATEGIES, TO ALLEVIATE
SOCIAL DETERMINANTS OF HEALTH
THAT AFFECT PEOPLE WITH HIV
RECEIVING QUALITY CARE INCLUDING
ENROLL NOTHING CLINICAL TRIALS,
OR CANCER SCREENINGS.
THIS IS CERTAINLY NOT AN
EXHAUSTIVE LIST WE FEEL IT MAY
BE IMPORTANT TO ADD IN
ADDITIONAL AREAS OF RESEARCH
SCOPE TO THE RFA SO WE WILL
CONFER WITH OUR DCCPS AND OUR
DCCP COLLEAGUES TO DEVELOP
BULLETS THAT MAY BETTER REFLECT
THE ENTIRE SCOPE OF THE RFA,
HOWEVER, WE ALSO WANT TO WORK TO
AVOID BEING 2 PRESCRIPTIVE IN
THE RFA.
NOW HEALTH DISPARITIES ARE OFTEN
AMPLIFIED OF MEMBERS WHO ARE
OFTEN MULTIPLE, INTERSECTIONS
ISSUES UNDERSERVED AND
MARGINALIZED GROUPS INCLUDING
LOW SOCIOECONOMICCAL GROUPS
ISSUES UNDERREPRESENTED RACIAL
AND EKING NICK POPULATIONS,
SEXUAL AND IMENDER MINORITIES
AND THOSE WHO LIVE IN
GEOGRAPHICALLY ISOLATED AREAS.
FOR EXAMPLE, REGARDING NEW HIV
INFECTIONS IN THE UNITED STATES,
40% OF THE THE INFECTIONS OCCUR
IN BLACK AND AFRICAN AMERICAN
INDIVIDUALS, ALTHOUGH THIS
POPULATION MAKES UP ONLY 12% OF
THE U.S. POPULATION.
TWENTY-NINE% OF NEW INFECTIONS
OCCUR IN HISPANIC AND LATINO
INDIVIDUALS, EACH THOUGH THIS
POPULATION MAKES UP ONLY 18% OF
THE U.S. POPULATION.
NOW WHEN CONSIDERING THOSE
BELONGING TO MULTIPLE MINORITY
GROUPS ISSUES THE NEW INFECTIONS
WERE 25% IN BLACK MEN WHO HAVE
SEX WITH MEN.
AND HISPANIC OR LATINO MEN WHO
HAVE SEX IN MEN, OF INFECTIONS
IN WOMEN 54% OCCUR IN BLACK
AFRICAN AMERICAN WOMEN WITH 18%
OCCURRING IN HISPANIC LATINO
WOMEN.
TWO% OCCUR IN TRANSGENDER PEOPLE
WITH 76% OF PEOPLE OCCURRING IN
TRANSGENDER PEOPLE OF COLOR.
CRCHD, OHAN AND THE DIVISION OF
CANCER BIOLOGY HAVE BEEN
COLLABORATING IN EFFORTS THAT
INFORMED THE DEVELOPMENT OF
INITIATIVES, ADDRESSING
DISPARITIES, AND SOCIAL
DETERMINANTS OF HEALTH RESEARCH
IN CANCER AND PEOPLE WITH HIV.
THROUGH THE NCI'S EQUITY AND
INCLUSION PROGRAM, OHAM, CRCHD
AND THE OFFICE OF CANCER CENTERS
COLLABORATED TO DEVELOP
ADMINISTRATIVE SUPPLEMENTS TO
THE P30 CANCER CENTER WORK
GRANTS.
WE HAD QUITE A ROBUST NUMBER OF
APPLICATIONS WERE RECEIVED AND 6
AWARDS WERE MADE EMPLOY THE
PURPOSE OFLET RFA OR THE NOFO
WAS TO DEVELOP IRPT DISPRINCIPAL
DEPUTYARY TEAM, ESTABLISH
RESEARCH INFRASTRUCTURE AND
SUPPORT EXPLORATORY PROJECTS
SEEKING TO UNDERSTAND THE ROLE
OF DETERMINANTS OF HEALTH AND
CANCER CARE INIQUITIES AND
LEADING TO CANCER DISPARITIES IN
PEOPLE WITH HIV, AND WE FELT A
REALLY IMPORTANT ASPECT OF THESE
ADMINISTRATIVE SUPLEMS WAS THAT
WE HIGHLY ENCOURAGED
COLLABORATIVE EFFORTS BETWEEN
CANCER CENTERS AND CENTERS FOR
AIDS RESEARCH.
SO CRCHD AND DCB DEVELOPED AN
RFA FOCUSED ON BASIC AND
TRANSLATIONAL RESEARCH IN HEALTH
DISPARITIES WITH THE IDEA THAT
BOTH THAT RFA, AND THIS
NOFOWOULD ADDRESS ISSUES OF
CANCER DISPARITIES IN PEOPLE
WITH HIV BUT WITH DISTINCT
SCIENTIFIC GOALS.
ONE INITIATIVE FOCUSES ON BASIC
AND TRANSLATIONAL RESEARCH AND
THIS CURRENT CONCEPT WILL
ADDRESS SOCIAL DETERMINANTS OF
HEALTH.
DESPATE THE FACT THAT NCI'S
PRIORITIZED RESEARCH
INVESTIGATING CANCERS IN HIVE,
THERE'S BEEN A LIMITED PORTFOLIO
ON SOCIAL DETERMINANTS OF
HEALTH.
A PORTFOLIO ANALYSIS OF FISCAL
YEAR 2023, INDICATED THERE WERE
2 PAID GRANTS, 1 R01 GRANT IN
RESPONSE TO A P. A. R. AND 1 KOA
GRANT O THIS IS A EMILY THED
RESEARCH PORTFOLIO WITH SOCIAL
DETERMINANTS OF HEALTH AND
CANCERS WITH PEOPLE WITH HIV.
OH HAM AND CHCRD ARE PLANNING TO
LAGISTICALLY MANAGE THIS RFA AS
OHAP TYPICALLY MANAGES A
TRANSNCI INITIATIVE, WE HAVE AN
NCI WIDE TEAM PUT TOGETHER, LED
BY OHAM AND CHCRD, WILL KETERM
RESPONSIVENESS AND REFERRAL,
PREPARE A FUNDING PLAN TOGETHER
AND CONDUCT AN EVALUATION OF THE
PROGRAM.
APPLICATIONS WILL BE REFERRED
ACROSS ALL NCIDLCs ACCORDING
TO DEA REFERRAL GUIDELINES, AND
WE WERE ENCOURAGED BY RELATIVELY
ROBUST RESPONSE TO OUR CANCER
CENTERS ADMIN TRAITIVE
SUPPLEMENT NOFO.
WE FELT THAT THE APPLICATIONS
REPRESENTED STRONG TEEMS WITH A
GREAT TEAL OF INSTITUTIONAL
INFRASTRUCTURE IN SUPPORT TO
MOVE THIS AREA OF RESEARCH
FORWARD IN A LITTLE BIT MORE
AGGRESSIVE WAY THAN WE WERE
FIRST PLANNING.
SO INSTEAD OF DEVELOPING AN
EXPLORATORY GRANT MECHANISM SUCH
AS A P20, WE THOUGHT THAT A UO1
MECHANISM WILL BE MORE
APPROPRIATE.
THIS WILL ALLOW A PROGRAM STAFF
TO FACILITATE REGIONAL AND
INSTITUTIONAL COLLABORATIONS
BETWEEN HIV AND CANCER
RESEARCHERS.
WE'RE ALSO PLANNING ON
DEVELOPING A PRINCE PALE
INVESTIGATORS MEETING TO FOSTER
DISSEMINATION OF INFORMATION,
DISCUSS CHALLENGES AND IDENTIFY
OPPORTUNITIES FOR COLLABORATION.
SO OUR BUDGET REQUEST WOULD BE 3
RECEIPT DATES FOR FISCAL YEAR
25, 26, AND 27 WITH 3 TO 4 UO1S
FOR EACH RECEIPT DATE.
FOR UP TO 12 AWARDS TOTAL,
$3 MILLION INVESTED FOR EACH
FISCAL YEAR, WITH $15 MILLION
OVER ALL REQUESTED FOR 5 YEARS
FOR EACH OF 3 RECEIPT DATES,
TOTALING $45 MILLION.
NOW IS THE CASE WITH MANY OHAM
PROJECTINGS, FUNDING WILL COME
FROM AIDS FUNDS RECEIVED THROUGH
THE OFFICE OF AIDS RESEARCH OR
O. A. R. AND THE CONCEPT HAS
BEEN REVIEWED BY THE OFFICE OF
AID RESEARCH AND KEEM
AIDS-ALIGNED.
SO AT THIS POINT I WOULD BE
HAPPY TO TAKE ANY QUESTIONS.
>> ANNA MARIA?
>> THANK YOU TO THE DOCTORS WHO
MET WITH US AND TO MY TEAM
MEMBERS DR. [INDISCERNIBLE] AND
DR. ROBERTON, WE HAD A LOT OF
ENTHUSIASM FOR THIS PROPOSAL,
VERY MUCH APPRECIATED THAT IT IS
A TRANSNCI EFFORT AND
COLLABORATION AND THAT THE WORK
IN TRYING TO UNDERSTAND CANCER
IN PEOPLE WITH HIV IS
NONAPOPTOTIC THE NEW. THIS IS
SOMETHING THAT HAS BEEN IN PLACE
BUT THIS IS REALLY THINKING MORE
BROADLY, NOT JUST WHAT CANCERS
ARE ASSOCIATED WITH HIV, BUT
CANCERS IN PERSONS WITH HIV.
AND AS ROBIN MENTIONED EARLIER,
THE DEMOGRAPHICS ARE CHANGING SO
WE NEED TO BE THINKING ABOUT
LUNG CANCER FOR EXAMPLE, SO VERY
IMPORTANT AREA TO FOCUS ON.
ALSO OUTLINING CAREFULLY THAT
THERE ARE MULTIPLE FACTORS HERE,
PATIENT FACTORS, CLINICIAN
FACTORS COMMUNITY FACTORS,
HEALTH SYSTEM FACTORS, BUT THAT
WITHIN ALL OF THAT ARE THE
SOCIAL DETERMINANTS OF WHAT I
SAY OF ILLNESS, AND THESE ARE
COMPLEX, THEY INTERSECT AND THEY
REINFORCE AS YOU MENTIONED.
SO YEE NEED TO BETTER UNDERSTAND
THESE STRUCTURES, UNDERSTAND THE
MULTILEVEL SOLUTIONS, AND THAT
WILL REALLY HELP US TO PROGRESS
IN AN AREA WHERE THERE IS A VERY
LIMITED PORTFOLIO.
SO WE WERE VERY ENTHUSIASTIC AND
VERY SUPPORTIVE OF THIS CONCEPT.
I TURN TO MY CO-TEAM.
>> YEAH, I CONCUR.
I THINK TO ADD ON TO WHAT ANNA
MARIA SAID IS FURTHER STRENGTH
OF THIS IS IT'S NOT JUST CANCER
TREATMENT BUT IT'S ALSO CANCER
KREENING AND HOW SOCIAL
DETERMINANTS OF HEALTH AND
PERSONS WITH HIV INTERACT WITH
THOSE, WITH THE WHOLE CONTINUUM
OF CANCER CARE.
>> EARL?
>> THANK YOU.
THANK YOU REBECCA.
THIS IS A GREAT PROGRAM, I THINK
THERE WILL BE A LOT THAT WE CAN
LEARN FROM THE WAY THIS IS SET
UP.
THANK YOU FOR ADDRESSING THE
QUESTIONS THAT WE HAD I THINK IT
HIGHLIGHTED A NUMBER OF AREAS
THAT REALLY IS CRITICAL FOR
UNDERSTANDING DETERMINANT OF
INDIVIDUALS OF HIV POSITIVE AND
ALSO EXPERIENCING CANCER.
AND I THINK AS WE GO FORWARD, I
THINK THIS PROGRAM WILL REALLY
HELP US UNDERSTAND HOW THESE
INDIVIDUALS ARE DEALING
WITH--WHAT THESE INDIVIDUALS ARE
DEALING WITH IN TERMS OF THE
SOCIAL ASPECT OF IT BUT MORE SO
HOW WE CAN ACTUALLY HELP THEM
THAT THE BASIC STRUCTURAL
PROBLEMS THAT THEY'RE FACING IN
SOCIAL VIERPTS SO THANK YOU FOR
DOING THAT.
>> [INDISCERNIBLE]
>> THERE'S NOTHING THAT GETS
EXCITING MORE THAN SOCIAL
DETERMINANTS OF HEALTH.
JUST A COUPLE THOUGHTS AS
SOMEONE WHO LIVES IN THAT WORLD,
SO I THINK THERE ARE LOTS OF
CONCEPTUAL MODELS AROUND SOCIAL
DETERMINANTS OF HEALTH AND I
THINK IT'S IMPORTANT FOR THIS
RFOOTWORKA TO CONSIDER, BUT THE
CORE I'M THINK BEING IN MY HEAD
IS W. H. O. MODEL AROUND SOCIAL
DETERMINANTS OF HEALTH.
I THINK THE OVERTIME THE
THINKING HAS EVOLVED SO THAT YOU
THINK ABOUT STRUCTURAL
DETERMINANTS AND THEN THE SOCIAL
DETERMINANTS AND HELT CARE
DETERMINANTS, FOR THIS BROAD LYE
TO GET WHAT CALLED THEM ALL
SOCIAL DETERMINANTS, REASON I
SAY SO IS THAT WHY WE THINK
ABOUT IT, IT HAD MULTIPLE
FACTORS THAT CONTRIBUTE TO A
FABLGHTOR THAT CONTRIBUTE SOCIAL
DETERMINANTS, AND I AM ACTUALLY
YET TO SEE SOMEBODY WHO ACTUALLY
HAS 1 SOCIAL DETERMINANTS OF
HEALTH OR SOCIAL FACTOR.
WE KREEN AND WE FIND MULTIPLE
THINGS IN INDIVIDUALS TO DIG
DEEPER INTO IT, BUT THE POINT
I'M GETTING TO IS THAT THERE MAY
BE A HIERARCHY TOWARD THE
FACTORS, IF YOU THINK ABOUT
EDUCATION ASSAY, NATIONAL
PROXIMAL FACTOR THAT LEADS TO
UTILITIES AND PERSONAL BALANCE
AND I THINK HAPPENING THINK
ABOUT HOW THOSE ARE IMPORTANT
BUT ALSO I THINK THE CONCEPT OF
SOCIAL DETERMINANTS IS BROAD AND
DEVALUE ON HOW YOU ALLOW FOR
LATITUDE BUT ALSO SUBMIT TO MORE
PRESCRIPTIVE OR GUIDANCE PEOPLE,
RESPECTFUL CARE SOCIAL
DETERMINANTS, SO THERE WAS A
SORT OF HAD IN MY HEAD AND I
WANT TO SHARE THAT WITH YOU TO
CONSIDER.
IN, ANDREA.
NYES, I WANTED TO SART OF ADD TO
THAT, THOSE TOOK SOME PART OF MY
QUESTION, BUT WHEN YOU ARE
TALKING ABOUT SPECIFIC SOCIAL
DETERMINANTS OF HEALTH I THINK
IT'S IMPORTANT TO MAKE SURE
THAT'S BROADLY DEFINED TO MAKE
SURE FOLKS ARE NOT OHM THINKING
ABOUT FOOD SIN E CURITYS BUT
ALSO THINKING ABOUT SLEEP
DEPRIVATION AND HOW THOSE ARE
COMPLEXLY ADDITIVE OR
MULTIPLICATIVE IN CAUSING STRESS
AND CANCER AND THERE'S SOME VERY
RECENT STUDIES THAT SHOW IF YOU
TAKE MICE AND YOU DEPRIVE THEM
OF FOOD AND GIVE THEM FOOD
INSECURITY THEN THE TUMOR
TRIPLES IN SIZE, SO THIS IS A
REALLY CRITICAL STUDY TO TRY TO
GET AS MUCH INFORMATION AS
POSSIBLE IN A VERY BROAD
DEFINITION OF SOCIAL
DETERMINANTS OF HEALTH SO THOSE
INDIVIDUAL TYPES OF STRESSORS
CAN BE TEASED OUT.
NYES, FANTASTIC, AND KIND OF
OVERVIEW, THIS IS A GREAT TOPIC
AND I DO THINK IT MIGHT BE ABLE
TO BE A PRACTICAL APPLICATION OF
THE NIH WIDE COMMISSION ON
THINKING ABOUT SOCIAL DETERMINE
NABTS OF HEALTH I'M SURE YOU
PROBABLY DISCUSS THAT, I THINK
THERE NEED TOTION BE A COMMON
COMMON
DEFINITION, AND THEN ALSO REALLY
THINKING ABOUT THE DIFFERENCE
BETWEEN HEALTH AND RELATED
SOCIAL NEEDS RIGHT, VERSUS
SOCIAL DETERMINANTS WITH OFTEN
TIMES THAT ARE UPSTREAM SO LIKE
WHEN IT CAME TO THE THIRD BULLET
AND THINKING ABOUT THE RESEARCH
SCOPE, WE'RE TALKING ABOUT
RESEARCH IDENTIFYING AND TESTING
STRATEGIES TO,A LEAVEIATE SOCIAL
DETERMINANTS WAS IT REALLY
LOOKING AT SOCIAL DETERMINE
NABTS OR HEALTH SOCIAL NEEDS.
>> SORRY, HEALTH RELATED WHAT?
>> SOCIAL NEEDS?
>> I THINK AS WE WERE MOVING
THROUGH THIS, WE WERE TALKING
ABOUT--SO, SAY POVERTY OR
SOCIOECONOMIC STATUS, HOW WOULD
YOU ADDRESS, I CAN BE THE
ADDRESS A PERSON'S SOCIOECONOMIC
STATUS BUT IN THE CASE OF SOME
OF THE CLINICAL TRIALS THAT I'VE
BEEN INVOLVED WITH, WE CAN HELP
THE PEOPLE GET TO THE CLINICAL
TRIAL BY PROVIDING
TRANSPORTATION COSTS OR THINGS
LIKE THAT, AND SO I THINK THAT
IS HOW WE MIGHT WORK AND
ENCOURAGE SITES TO EXPLORE THOSE
TYPES OF OPTIONS TO ALLEVIATE
THE PROBLEM THAT RESULTS FROM
THE SOCIAL DETERMINANTS, DOES
THAT ANSWER YOUR QUESTION.
>> I THINK THAT'S MORE HEALTH
RELATED SOCIAL NEED
SPECIALIZATION OF SPECIFIC
ENDOTHELIAL I WOULD LOOK AT
LANGUAGE BECAUSE THERE IS A
DIFFERENCE BETWEEN SOCIAL
DETERMINE NABTS OF HEALTH,
SOCIAL RISK AND HEALTH RELATED
SOCIAL NEED AND THAT WILL IMPACT
WHAT THE OUTCOME IS GOING TO BE,
BECAUSE IF YOU SAY YOU WANT
PEOPLE TO ALLEVIATE SOME OF THE
SOCIAL DETERMINANTS OF HEALTH,
JUST BECAUSE YOU SAID
SOCIOECONOMIC STATUS WILL NOT
CHANGE, IN THE LANGUAGE.
>> LANGUAGE MATTERS NTHANK YOU,
YES.
NANYONE DOWN THERE AT THAT END
OF THE TABLE?
>> QUICK QUESTION, ON PAGE 7 OF
THE SLIDE, I WAS WONDERING IF
YOU CAN BRING IT UP AGAIN EMPLOY
I THINK IT JUST HELPS BECAUSE
THERE'S SEVERAL INDIVIDUALS
AIER, I WANT TO KNOW HOW THIS
WOULD BE DIFFERENT THAN ALL
THOSE HUNDREDS AND HUNDREDS OF
STUDIES WE'VE DONE EVERY YEAR,
FOR DECADES ON THAT SLIDE AND SO
THAT'S WHAT I WAS CURIOUS TO
KNOW ABOUT.
I THINK YOU JUST ANSWERED THE
QUESTION.
>> OH SURE, I WAS CURIOUS TO
KNOW, MY PERSPECTIVE WAS, YOU
HAD MENTIONED 32,000 NEW
INFECTIONS PER YEAR, AND I SEE
SINCE 2014, YOU'VE HAD ALL THESE
DISDS, I WANTED TO KNOW WHAT THE
STUDY WAS DIFFERENT THAN-
>> THESE AREN'T--THE BLUE IS THE
APPLICATIONS, ORANGE IS THE
AWARD, THESE ARE JUST HIV AND
CANCER AWARDS THEY DON'T ENTAIL
SOCIAL DETERMINANTS OF HEALTH.
>> WELL IT SAYS HEALTH
DISPARITIES AS WELL NTHE YELLOW
BAR, AND SOME YEARS IT'S 0.
>> AND SO THOSE 1S IN ORANGE
THEY ONLY LOOK AT HIV AND CANCER
THEY NEVER LOOKED AT--NETWORK
NO, THAT'S OUR--
>> I WOULDN'T SAY IGNORE IT,
THEY'RE JUST ADDRESSING
DIFFERENT QUESTIONS.
THEY CAN MEET THE CANCER THR
ACTIVITIES AND PROJECTSY, IT CAN
BE BASIC RESEARCH, THAT'S ACROSS
THE BOARD FOR NCI'S HIV CANCER.
>> THANK YOU.
>> CAN I HAVE A MOTION?
>> MOVE TO APPROVE.
>> SECOND.
>> OKAY, ANY FURTHER
DISCUSSION,.
>> I WILL BE A NAY.
>> OKAY.
ARE THERE ANY ABSTENTIONS?
>> OKAY, SO WE HAVE 1 NAY.
DPRAIT.
>> THAIRK YOU.
OKAY.
THEN THE NEXT PRESENTATION WILL
BE BY MICHAEL SCHMITT BUT HE
WILL BE VIRTUAL, THE NCI PATHWAY
TO INDEPENDENT AWARD THE K99 R00
AND OUR COMMITTEE IS JENNIFER,
TRAY AND SYLVIA, MICHAEL?
>> OKAY, THANK YOU AND GOOD
AFTERNOON AND THANK YOU FOR THE
OPPORTUNITY TO PRESENT THIS
CONCEPT, AND I WOULD LIKE TO
SPECIALLY THANK OUR REVIEWERS,
[INDISCERNIBLE] FOR REALLY
HELPFUL DISCUSSIONS AND
INSIGHTFUL COMMENTS.
THOUGH IN MY PRESENTATION, I
WANT TO GIVE YOU AN OVERVIEW OF
THE K99 R00 BRIEFLY PRESENT DATA
FROM OUR RECENT EVALUATION OF
THE OUTCOMES OF THIS MECHANISM
AND THEN PROPOSE OUR NEW NCI
SPECIFIC K99 R00, NCEYE K99
ROOPAR, IT IS TO HELP
OUTSTANDING POST DOCTORAL
STUDENTORERAL SCALERS TO
COMPLETE NEEDED MENTOR TRAINING
CAN TO HELP THEM, AS A TENURED
TRACK PROFESSOR IN A TIMELY
MANNER.
THE K99 ROO IS OUR ONLY CAREER
DEVELOPMENT AWARD THAT IS OPEN
BOTH TO YOU AS CITIZEN, AND NONE
U.S. CITIZEN.
NO APPLICANTS FOR THE K99 MUST
BE A MENTORED NONINDEPENDENT
POSITION, AND APPLICANTS MUST
HAVE NO MORE THAN 4IERS OF POST
DOCTORAL RESEARCH TRAINING
EXPERIENCE.
AT NCI WE SUPPORT ALL AREA OF
CANCER RESEARCH, VERY THE K99
R00.
WE HAVE RECEIVED TYPICALLY ARK
ROUND 200 APPLICATIONS PER YEAR.
AND OUR FINANCIAL COMMITMENT IN
THE PAST 5 YEARS HAS BEEN
RELATIVELY CONSISTENT AT ABOUT
$6.5 MILLION PER YEAR.
THE SUCCESS RATE IS AT ABOUT
59%, SO IT'S FAIRLY COMPETITOR
MECHANISM.
WE HAVE RECENTLY EVALUATED THE
OUTCOMES FOR THE NCI PARENT K99
R00 PROGRAM AND I THINK OUR DATA
SUGGESTS THAT THIS AWARD IS,
WOWORKING AT INTENDED.
IT FACILITATES SUCCESSFULLY THE
TRANSITION OF POST DOCTORAL
[INDISCERNIBLE] INDEPENDENCE AND
ENHANCING THE LIKELIHOOD OF K99
AWARDEES TO SECURE RO-1 OR RO-1
LIKE GRANTS AWARD.
ABOUT 90% OF K99S TRANSITION TO
INDEPENDENCE AND AROUND 65% OF
K99 AWARDEES ARE ABLE TO SECURE
R01 EQUIVALENT GRANT SUPPORT.
WE ALSO OBSERVED THAT SEX OR
GENDER AS WELL AS RACE AND EGHT
INISSITY HAD NO SIGNIFICANT
IMPACT, EITHER ON THE TRANSITION
RATES OR ON THE R01 AWARD RATES.
SO THIS MEANS THIS AWARD IS
WORKING FOR EVERYBODY.
IT IS AN IMPORTANT TOOL FOR
WORKFORCE DEVELOPMENT.
WE HAVE RECENTLY PUBLISHED THE
RESULTS OF THE STUDY IN THE
YOWRNAL OF CANCER EDUCATION AND
1 COMPONENT OF THIS STUDY HAD
AURE VEY AND INTERVIEW WITH K99
APPLICANTS, K99 AWARDEES, AS
WELL AS NCI, R01 ITIs WHO
NEVER APPLIED FOR A K99 TO GET A
BETTER UNDERSTANDING ABOUT WHAT
IS WORKING WELL WITH THIS
MECHANISM AND IF THERE ARE ANY
PROBLEMS, ANY ISSUES AND THE
OVERWHELMING FEEDBACK WE
RECEIVED FOR THE K99 AWARDS FOR
THIS MECHANISM THAT'S THE K99
R00 WAS TRIEWMENTAL IN THEIR
TRANSITION TO INDEPENDENT AND
HELP THEM TO TEAB A PRODUCTIVE
INDEPENDENT RESEARCH PROGRAM.
AND THEY TOLD US THAT THE K99
AWARD WAS ESSENTIALLY A GOLDEN
TICKET TO BE INVITED FOR TENURED
TRACK INTERVIEW, AT AN
INSTITUTION OF THEIR CHOICE AND
OUR DATA SUPPORTS US, WE CONTROL
THE K99 AWARDEES HAVE HIGHER
MOBILITY COMPARED TO OUR CONTROL
GROUPS.
HOWEVER THERE WAS 1 MAJOR PAIN
POINT BUT YOU HEARD FROM
APPLICANTS AS WELL AS ESAIs,
AND THIS WAS UNIQUE REQUIREMENT
OF THE K99--IT'S A EFFORT ON
HIGH IMPACT PUBLICATIONS.
BECAUSE THEY REQUIRE A LONG
TIME.
AND IT WOULD PENNALLIZE
EVERYBODY WHO IS SOMEWHAT
UNCONVENTIONAL PATHWAY IN THEIR
CAREER DEVELOPMENT.
THIS INCHEWEDS POST DOCS WHO
CHANGE THEIR RESEARCH FIELDS,
CHANGE LABS, YOU HAD ANY ISSUES,
[INDISCERNIBLE] AND SO ON, WHAT
WE ARE NOW PROPOSE SUGGEST
REALLY ONLY A MINOR CHANGE TO
THE K99 PROGRAM.
BE PROPOSED TO EXPAND THE
ELIGIBILITY FROM 4 YEARS TO 6
YEARS OF POST DOC EXPERIENCE.
NOW THIS CHANGE WILL REQUIRE
THAT NCI HAS ISSUING OUR OWN K99
R00 P A R.
WE EXPECT THAT THIS CHANGE WILL
LEAD TO AN INCREASE IN THE
APPLICATION NUMBERS FROM
CURRENTLY 200 APPLICATIONS PER
YEAR, 2 TO 300.
AND THEN OF COURSE, OUR BUDGET
FOR THE K99 WILL INCREASE FROM
CURRENTLY 6 MILLION TO AROUND
$10 MILLION.
NOW IF THE IMPLEMENTS CHANGE OUR
PLAN IS TO SUN SET THE K22 P A
R, BECAUSE THIS MECHANISM WILL
BE NO LONGER NEEDED.
SEE K22 P A R IS A CAREER
DEVELOPMENT AWARD THAT ALLOWS UP
TO 8 YEARS OF POST DOC
EXPERIENCE AND IS OVERALL THE
EQUIVALENT OF THE R00 PHASE FROM
THE K99 R00.
THIS MEANS THE K22 ONLY SUPPORTS
POST DOCS, AFTER THEY HAVE
TRANSITIONED TO THEIR RESEARCH
INDEPENDENT.
WE ARE NOT REQUESTING ADDITIONAL
FUNDING FOR THE NCI K99/R00 P A
R BECAUSE THE EXPECTED COST OF
THIS PROGRAM WOULD BE LESS THAN
THE COMBINED COST OF THE CURRENT
[INDISCERNIBLE] K99 AND THE K22
COMBINED.
HOWEVER, THE COST FOR THE R00
PHASE WILL INCREASE BY
$6 MILLION, TO ABOUT
$25.5 MILLION.
WITH OUR OUR REVIEWERS AND OUR
SUBMITEE, WE HAVE DISCUSSED
POTENTIAL DOWN SIDES AND
UNINTENDED CONSEQUENCES AND 1
CONCERNED REVIEWERS RAISED WAS
THAT CHANGE, THIS CHANGE FROM 4
YEARS TO 6 YEARS OF POST DOC
EXPERIENCE PUT [INDISCERNIBLE]
REVIEW BIAS FOR MORE EXPERIENCE
APPLICANTS, APPLICANTS WHO MAYBE
HAVE MORE PUBLICATIONS OR
STRONGER TRAINING EXPERIENCE.
AND WE PLAN TO ADDRESS THIS BY
MODIFYING THE REVIEW CRITERIA
FOR THE NCI K99 RWHERE ARE 0
[INDISCERNIBLE] ANNOUNCEMENT.
AND WE WILL REQUEST THAT
REVIEWERS WHO WANT TO WAIT
APPLICANTS IN THE CONTEXT OF
THERE ARE CAREER STAGE AND WE
WILL REQUEST THAT REVIEWERS
FOCUS ON THE READINESS OF
APPLICANTS FOR THEIR TRANSITION
TO INDEPENDENCE, INDEPENDENT OF
YEARS OF POST DOCTORAL TRAINING
RECEIVED.
THEN THERE WAS A CONCERN THAT AN
TENSION TO 6 YEARS WE MIGHT NOT
BE AS SUFFICIENT.
THAT IT MIGHT BE BENEFICIAL TO
EXTEND MAYBE TO 10 YEARS, BUT TO
JUST SIMPLY REQUIRE THE K99
APPLICANTS MUST BE IN A MENTORED
NONINDEPENDENT POSITION.
AND I THINK THIS A VERY
INTERESTING SORT, BUT WE FEEL IT
MIGHT BE BEST TO REALLY HAVE A
MORE [INDISCERNIBLE] THOUGHT TO
GO TO INCREASE ABILITY FROM 4
YEARS TO 6 YEARS AND MONEY TO
OUR APPLICANT POOL, MONITOR OUR
DEEP POOL AND THEN PROPOSE
FURTHER EXTENSIONS IN THE FUTURE
IF NECESSARY EMPLOY AND OF
COURSE WE WILL CONTINUE TO BE
FLEXIBLE BY PROVIDING EXIBILITY
FOR CRITICAL LIFE EVENTS AND
EXTENSIONS AND SO ON.
AND THEN THERE WAS CONCERN THAT
WE SHOULD BE VERY SPECIFIC IN
THE PROGRAM ANNOUNCEMENT ABOUT
ACCEPTABLE POSITION TITLES FROM
OUR POST DOCTORAL APPLICANTS, TO
COMA TITLES ARE ELIGIBLE, AND
WHICH ARE NOT ELIGIBLE AND OUR
PLAN WOULD BE TO ALLOW
APPLICATIONS FROM RESEARCH
ASSOCIATES, STAFF SCIENTISTS,
AND INSTRUCTORS, AS LONG AS THEY
CAN JUSTIFY THAT THEY ARE IN THE
MENTORS NONINDEPENDENT POSITION.
NOKAY, THANK YOU VERY MUCH AND I
WOULD LIKE TO--I WILL BE WELCOME
TO ANSWER QUESTIONS.
>> WELL, I'M ANYTHING TO BE
INTERESTED IN THE COMMITTEE
REVIEWED HERE MYSELF.
NREADY?
>> YES.
>> YOU WANT TO ASK FIRST OR GO
FIRST?
>> WE LOVE THIS.
AND THE REASON WE LOVE THIS IS
BECAUSE THE K99 IS 1 OF THE VERY
FEW MECH NICHES THAT WILL
SUPPORT INDIVIDUAL WHO IS ARE
NOT U.S. CITIZEN AND MANY OF OUR
TRAINEES ARE NOT ELIGIBLE FOR
K08S FOR EXAMPLE OR K22S BECAUSE
OF THAT REQUIREMENT WHICH I
THINK MOST OF US WOULD AGREE HAS
AN EXTRAORDINARY HA MOUNT OF
DIAS AND THERE'S NOT A LOT OF
RATIONAL IN TODAY'S
MULTICULTURAL U.S. TO NOT ALLOW
THESE PEOPLE TO APPLY, IT IS
ABSOLUTELY THE GOLDEN TICKET,
THOSE OF US WHO HAVE MENTORS K99
AWARDEES, THOSE OF US WHO HAVE
HIRED PEOPLE WITH R00S
UNDERSTAND THAT THIS IS AN
EXTRAORDINARY MECHANISM AND IT
NEEDS TO BE PRESERVED AND
THERE'S NO DOUBT THAT THE 4 YEAR
TIME SPAN REQUIRES AN ARTIFICIAL
ADHERENCE TO THE IDEA THAT YOU
HAVE TO SUBMIT BY THIS DATE, AND
SO HAVE YOU 2 SHOTS ON GOAL.
AND THAT'S A TERRIBLE IDEA
BECAUSE GRANTS SHOULD BE
SUBMITTED WHEN THEY'RE READY AND
SO WE WERE REALLY EXCITED ABOUT
THIS NEW FLEXIBILITY, WE THINK
IT WILL OPEN UP THE APPLICATION
POOL TO A MORE DIVERSE POOL OF
TALENTED INDIVIDUALS AND REALLY
FULFILL THE PROMISE OF THIS
AWARD.
WE DID INTRODUCE THIS WHACKY
IDEA OF ELIMINATING ANY KIND OF
A YEAR LIMIT.
IT'S REALLY THE SPIRIT OF TAKING
SOMEONE WHO'S IN A
MENTOREDDUATION AND PROVIDING
THEM A PATHWAY TO INDEPENDENT
BUT WHAT YOU DIDN'T MENTION
DR. SCHMITT THAT WE REALLY
APPRECIATED IS THAT THIS NEEDS
TO BE CULTURALLY HARMONIZED
WITHIN THE NIH AND THAT ALREADY
NCI'S DOING SOMETHING RADICAL BY
GOING FROM 4 YEARS TO 6 YEARS SO
WE'RE VERY RESPECTFUL OF DOING
THIS INCREMENTALLY BUT WE REALLY
LOVE THE IDEA AND MAYBE WHAT ID
JUST SAY SLIGHTLY DIFFERENTLY
DR. SCHMITT IS WHAT WE WANT TO
EMPHASIZE IS THAT SO MANY OF OUR
INSTITUTIONS AND YOU KNOW TRAIR
AND I WORK AT THE UNIVERSITY OF
CALIFORNIA, YOU CAN'T BE A POST
DOC FOR MORE THAN 5 YEARS AND I
THINK THIS IS TRUE IN MANY, MANY
PLACES, SO WHY NOT ELIMINATE THE
YOB CORPS TITLE IN SO RATHER
THAN CALL IN A POST DOCTORAL
SCHOLAR ARK WARD OR ANYTHING
THAT IT IMPLIES A SPECIFIC
TITLE, IT'S REALLY A MENTORED
AWARD FOR SOMEONE HAS A PATHWAY
TO INDEPENDENT.
BUT WE WERE VERY ENTHUSIASTIC
AND APPRECIATED THE CONVERSATION
WITH DR. VOGLER AND SCHMITT AND
THANK YOU FOR TAKING OUR
COMMENTS INTO CONSIDERATION AND
I WILL TURN IT OVER TO TREY AND
SYLVIA.
>> I'LL KEEP MY COMMENTS BRIEF
BECAUSE I THOUGHT MICHAEL DID A
FANTASTIC YOB CORPS IN
PRESENTING THE CONCEPT AND JENNY
DID A FANTASTIC JOB OF
SUMMARIZING THE DISCUSSIONS WE
HAD ON SUBEXITEE.
MY INPUT ALREADY WAS MADE THERE,
I'LL JUST SIMPLY REPEAT IN
60-SECURITIZATION.S OR LESS THE
HIGHLIGHTS, ALL THINK AFRONS OF
US ON THE SUBCOMMITTEE HAVE BEEN
TOUCHED, PEOPLE IN OUR LAB
TOUCHED IN A POSITIVE WAY BY
K99S AND SEEING THE MAGIC THAT
HAPPENS TO THEIR CAREERS, IT'S
JUST AN AND AGAIN,LET FACT THAT
IT'S OPEN TO NONU.S. CITIZEN IS
PHENOMENAL AND THE EXCEPTION AS
FAR AS I KNOW AMONG THE NIH,
K99S.
IN TERMS OF THIS VERY
INTERESTING SUGGESTION TO JUST
DROP THE REQUIREMENT, WELL,
YEAH, SO, IF YOU'RE GOING TO
DROP THE REQUIREMENT OR EXTEND
THE REQUIREMENT, YOU WANT TO
MAKE SURE YOU DO NOT KEEP
UNWITTINGLY BIAS THIS TO
INSTITUTIONS WHO ALLOW 6 YEAR
POST DOCS BECAUSE MANY DON'T.
SO YOU HAVE TO DEAL WITH JUST
THE NAMING AND THE MESSAGING
THERE AND JENNY ALREADY CAPTURED
THAT AND IN TERPS SHOULD WE DROP
IT, GO TO 6 YEARS, 4 YEESHS, 10
YEARS, THE COMMITTEE IS EQUALLY
CONFUSED IN A WAY, WE AGREE IT'S
A COMPLEX ISSUE AND SO REALLY
THE PROPOSAL TO DROP IF I COULD
ADD ANYTHING WAS SIMPLY
[INDISCERNIBLE], WE DON'T KNOW
WHAT THE BEST THING TO DO IS AND
THEREFORE DO LESS.
ANYTIME YOU DRAW A LINE IN THE
SAND, YOU'RE PERTURBING A SYSTEM
IN A COMPLEX WAY AND IT'S HARD
TO ANTICIPATE AND I THINK
MICHAEL'S PUSH BACK WAS WE WILL
STUDY THIS BUT WE THEED TO
UNDERSTAND THE THRESHOLD AND
IT'S COMPLICATED.
>> SYLVIA?
>> YEAH, I GREAN, I THINK THE
DISCUSSION VS BEEN REALLY
FRUITFUL.
I THINK I WILL TOUCH ON SOME
POINTS THAT WERE ALREADY MADE
BUT MAYBE A LITTLE BIT MORE TO
THE DISCUSSION.
SO I DON'T THINK WHAT WAS
MENTION INDEED THE PRESENTATION
AND THE SUBCOMMITTEE IS ORIGE
NAWILLLY THIS PROGRAM WAS AT 5
YEARS AND THEN IT MOVED TO 4
YEARS SO ALIGNED WITH THE NIH
GUIDELINES, THE WHYED IS TO NOW
MOVE OUT OF THE NIH UMBRELLA AND
BRING IT TO THE NCI AND
INCREASING NOT TO 5 YEARS BUT TO
GO TO 6 YEARS, SO WE WERE KIND
OF ASKING, WHY NOT GO BACK TO 5
YEARS, WHY 6 YEARS, WHY ANY
YEARS, AND SO I BEING THE INTEND
IS THE RIGHT INTENT WE'RE ALL
READY TO DISCUSS.
IT IS A IMPORTANT ISSUE.
ONE OF THE DISCUSSION POINT WAS
THAT THERE'S DIFFICULT MOUSE
MODEL RESEARCH FOR EXAMPLE THAT
JUST TAKES A REALLY, REALLY LONG
TIME AND SOME PEOPLE DON'T GET
THAT BIG PAPER OUT FOR LIKE 5 OR
6 YEARS, AND SELL, AND IN SOME
WAY, YOU KNOW I WAS MAKING THE
POINT, DO WE REALLY WANT TO
ENCOURAGE, LIKE, YOU KNOW A 1
PAPER PERSON, LIKE WORKING FOR 6
YEARS ON 1 CELL PAPER, IS THAT
WHAT WE REALLY WANT TO
ENCOURAGE.
BUT I THINK THAT GETS INTO
MINUTIA, I THINK THE FLEXIBILITY
IS BETTER AND AS WAS SHARED BY
MY COLLEAGUES ON THE
SUBCOMMITTEE AND IN THAT MIND
SET OF FLEXIBILITY, THIS ACTION
IS REALLY TIED TO ULTIMATELY SUN
SETTING THE K22, AND THE TITLE
OF THE K22 IS A CAREER
TRANSITION AWARD.
SO IT HAS A DIFFERENT KIND OF
FLAVOR TO IT AND WE DON'T WANT
TO LOSE THAT THERE'S A POOL OF
PEOPLE THAT WE WANT TO
NECESSARILY BRING BACK INTO
ACADEMIA, WHILE, YOU KNOW
THEY'RE POST DOCTORATES NOT
DOING POST DOCTORAL RESEARCH IN
THE TECHNICAL SENSE OF THE WORD,
THE WAY YOU APPLY AT AND YOU WE
ALSO HAVE THE 5 YEAR RULE, SOME
OF THESE FOLKS AFTER 5 YEARS
MOVE INTO INTRUCTOR POGS OR
RESEARCH SCIENTISTS POSITIONS
AND AS LONG AS THEY'RE A MENTOR
THAT WOULD BE ELIGIBLE AND THAT
GOT TO A THIRD DISCUSSION SLIDES
AND SUBCOMMITTEE DISCUSSION AND
SO I JUST WANT TO REEMPHASIZE
THAT POINT BECAUSE THERE IS A
POST DOCTORAL TRAINING CONCEPT
BUT PEOPLE DO POST DOCTORAL
RESEARCH IN OTHER ENVIRONMENTS
AND INDUSTRY AND WANT TO
TRANSITION BACK INTO ACADEMIA,
SO AS LONG AS WE CAPTURE THAT
ELEMENT AND KEEP THAT ELEMENT
WITH THE SUN SETTING OF K22,
TELL BE A VERY SUCCESSFUL
PROGRAM.
NCHAIR'S PREROGATIVE, I ONLY
WORRY ABOUT IT FLIES IN THE FACE
OF WE HAVE, WE ARE PUSHING BACK
THE TIME FOR FIRST RO-1S SO FAR
ALREADY.
IESM WORRIED ABOUT STUDY
SECTIONS BASICALLY, WE CAN TELL
THEM WHAT TO DO, QUOTE-UNQUOTE
BUT NOW 6 YEAR ANYTHING TO BE
THE NORM FOR THIS SO I THINK
THERE NEEDS TO BE REAL
DISCIPLINE FROM THE STUDY
SECTIONS IF PEOPLE ARE READY, AT
4 YEARS OR 5 YEARS, THEY SHOULD
BE ABLE TO GO FORWARD.
NI AGREE WITH YOU SHELLY AND
DR. SCHMITT, YOU DID YOURSELF
CREDIT, THEY ARE STUDYING WHAT
THEY ARE DOING, IT'S AN
ITERATIVE PROCESS, AND THIS IS
JUST MAKING SURE WE DON'T PUSH
THE FIRST RO-1 DOWN THE LINE BUT
INCREASING OPPORTUNITIES FOR
INDIVIDUALS WHO NEED THIS GRANT
IN ORDER TO SUCCEED.
>> PROGRAM'S BEEN TERRIBLY
SUCCESSFUL.
>> HERE, HERE.
OH BOY, OKAY.
>> I'M SORRY.
NASHLEY GO AHEAD, SO FIRST OF
ALL I LOVE THIS, I HAVE A
HUNDRED PERCENT EXCITE BIDE THIS
AS SOMEONE WHO'S TRAINEES WORK
ON 18 MONTH OLD MICE IT'S LOVELY
THEY GET MORE TIME TO GET
PAPERS.
I JUST WANTED TO ASK WHETHER
THERE'S ANY MOVE OR ANY THOUGHT
ABOUT A MOVE TO SHIFTING K08S TO
BEING NO LONGER U.S. RESTRICTED?
BECAUSE LOWER INCOME MINORITY
COUNTRIES I HAVE POST DOCS FROM
BRAZIL, AFRICA, THEY HAVE NO
OPPORTUNITIES FOR K99, THEY
OFTEN COME IN LATER IN THEIR
POST DOC, FOR K08, AND THEY
OFTEN COME IN LATER FOR K99S AND
MISS THE WINDOW WHICH MAY NO
LONGER BE AN ISSUE BUT TILL.
>> WE ARE RUNNING OUT OF TIME,
LET'S GO QUICKLY.
>> THE OPPOSITE DIRECTION, THE
FITTER THING WE SEE ARE THE
PEOPLE APPLYING FOR THE K99
ROOs THE MORE THEY'RE EXPECTED
TO HAVE, AS YOU MOVE THAT TIME,
REVIEWER NATURALLY IN THEIR
HEAD, NO MATTER WHAT YOU SAY TO
THEM IN A REVIEW COMMITTEE SAY
THIS PERSON'S BEEN OUT FOR 5
YEARS, YOU KNOW ESPECIALLY FOR
US IN POPULATION SCIENTISTS WHO
ARE DOING THESE K99 ROOs, WHY
DON'T I HAVE HAVE 25
PUBLICATIONS INSTEAD OF 17, SO
YOU HAVE TO BE REALLY CAREFUL
ABOUT THAT AS PART OF THIS
BECAUSE THAT COULD HAVE A SUPER
UNINTENDED QUONSQUENCE WHERE YOU
MOVE THE TIME BUT YET THE
PARALSO MOVES IN TERMS OF WHAT'S
EXPECTED OF THESE INDIVIDUALS.
AND 1 LAST THING, WE'VE ALREADY
HAD SUCCESS WHERE WE HAVE PEOPLE
WHO ARE ON LIKE FOR EXAMPLE OUR
NCI T32 WHERE WE GIVE THEM
RESEARCH ASSISTANT PROFESSOR POG
ANDS NCI HAS GRANTED US YOU ARE
IN A MENTORED POSITION, YES,
THESE INDIVIDUALS ARE ALLOWED
TO,A PLIE AND THEY GIVE THAT
EXCEPTION OR THAT ALLOWS RIGHT
NOW WITH THE WAY IT'S CURRENTLY
WRITTEN.
SO I WOULDN'T SEE WHY THOSE
OTHER POSITIONS COULDN'T DO THE
SAME >> GRAPT, BE QUICK NYES.
>> SO I LIKE THIS VERY MUCH, MY
QUESTION IS, SINCE THEY WILL NOW
BE ARK LOWED 6 YEARS TO DEVELOP
A FULL PROJECT ARE THEY REQUIRED
TO SPEND THE 2 YEARS IN MENTORED
POSITION BEFORE THEY CAN MOVE TO
THE INDEPENDENT POSITION?
>> NO THEY ARE NOT.
AT NCI WE ARE VERY FLEXIBLE, WE
ALLOW TRANSITIONS IN THE FIRST
YEAR OF THE K99 PHASE HOWEVER
THESE REQUIRE APPROVAL DIRECTOR
OF KRRK CT AND THEY HAVE TO
ACQUIRE THESE EARLY TRANSITIONS
ARE SUPPORTED BY A VERY STRONG
OFFER FOR TENURED TRACK
POSITION.
BUT IF OUR K99 AWARDEES HAVE A
STRONG SPOGZ, WE DON'T
[INDISCERNIBLE] BACK, WE ALLOW
THEM TO MOVE ON TO INDEPENDENCE
AS EARLY AS POSSIBLE AND I WOULD
REALLY LIKE TO CLEARLY STATE IT
IS NOT OUR INTENTION TO ECTEND
THE POST DOC PERIOD BEFORE
ANYBODY CAN MOVE ON TO
INDEPENDENCE.
OUR GOAL IS TO HELP THEM, TO
MOVE ON TO INDEPENDENCE AS EARLY
AS POSSIBLE, HOWEVER WE WANT TO
BE A LITTLE MORE FLEXIBLE BY
UNDERSTANDING.
>> WE HAVE TO MOVE ALONG,
MICHAEL ANYTHING REALLY NEW,
REALLY NEW.
YOU WILL BE EVALUATED.
[INDISCERNIBLE] >> VERY
DISCOURAGING FOR OUR JUNIOR
PEOPLE AND I WOULD RATHER HAVE
SHORTER YEARS BUT I'M FINE WITH
6 YEARS BUT I WOULD LIKE TO
REWARD THE GO GETTERS THAT WILL
BE IN POPULATION SCIENCE WHO
NEED ONLY 1 OR 2 YEARS THAT THEY
DON'T GET THIS ADVANTAGE AND
LET'S THINK ABOUT THIS PAY LINE
BECAUSE 15% IS VERY LOW OR
HAVING PEOPLE MOVE ON.
AND MY QUICK COMMENT IS BY DOING
THIS ONLY THROUGH NKRRK I AND
NOT HAVING OTHER INSTITUTES OR
SO, GOING IN YOU WILL INCREASE A
LOT OF APPLICATIONS OF PEOPLE
THAT MAY BE I'M NOT REALLY
CANCER RELATED BUT THEY'RE GOING
TO TAKE THESE, MAYBE IT'S NOT AN
ISSUE BUT OTHER DISCUSSIONS
WITHIN NIH TO MAKE THIS PRODUCT.
NWE WILL HAVE TO HAVE A VOTE.
IT'S GREAT TO BE HERE TOGETHER
BECAUSE WE REALLY WANT TO TALK.
DO WE HAVE A MOTION NI MOTION TO
APPROVE NSECOND.
>> OKAY, ARE THERE ANY NAYS?
>> DISCUSSION.
>> JUST THE POINT LOOK AT THAT
SLIDE ABOUT THE DISTRIBUTION BY
RACE, I DON'T AGREE THIS IS
BALANCED, I WANT TO MAKE THAT
POINT PERHAPS WE SHOULD LOOK AT
THAT DATA MORE CLOSELY.
IT DOESN'T TILLLY MEAN IT'S
BALANCED.
>> ANY NAYS, ANY ABSTENTIONS?
UNANOG --UNANIMOUS.
IT'S GREAT TO BE TOGETHER.
THE NEXT IS TOBACCO CONTROL AND
CANNABIS CONTROL POLICY, WELL
THAT WOULD BE OF INTEREST.
THAT WOULD UNANIMOUS, RESEARCH
FOR HEALTH EQUITY PRIEL
DR. ANNETTE KAUFMAN AND OUR
COMMITTEE IS DOROTHY RAY AND
KAREN.
DOES EVERYBODY NEED A SEVENTH
INNING STRETCH, I FEEL LIKE
MAYBE WE DO.
THANK YOU FOR THE OPPORTUNITY TO
PRESENT THIS CONCEPT ON TOBACCO
ALCOHOL AND CANNABIS CONTROL
POLICY FOR RESEARCH HEGHT
EQUITY.
ALL RIGHT RNTION SO THE GOAL OF
THESE PARS ARE TO SUPPORT R21
AND RESEARCH PROGECS THAT FOCUS
ON REDUCING DISPARITIES IN
TOBACCO ALCOHOL AND/OR KAN--KANA
BUSINESS PROGRAMS EXPOSURE OR
USE BY EVALUATING NEW OR
ADAPTIVE POLICIES PERTAINING TO
TO BACK O ALCOHOL AND/OR
KAN--KANA BUSINESS PROGRAMS IN
THE UNITED STATES.
BROADLY IN PARWILL AIM TO
ADDRESS THE OVERARCHING
HYPOTHESIS THAT TABAK O WHOLE
AND/OR KAN--KANA BUSINESS
PROGRAMS POLICIES DIFFERENTIALLY
IMPACT THE EXPOSURE AND/OR USE
OF SUBSTANCES AMONG DISPARATE
POPULATIONS.
AS BACKGROUND TOBACCO ALCOHOL
AND KAN--KANA BUSINESS PROGRAMS
ARE THE MOST FREQUENTLY USED
DRUGS IN THE UNITED STATES
ACCORD TO THE 2022 NISDA DATA
PEOPLE AGE 12 ORLEDDER USED THE
FOLLOWING PRODUCTS IN THE PAST
MONTH AND WE KNOW THAT
DISPATHWAY GIVES ARITYS EXIST
FORRULE 3 SUBSTANCES, 12 MONTH
AND LIFETIME COMOAL USE DISORDER
AND HIGHEST WITH THOSE WITH
LOWER INCOME, CURRENT CIGARETTE
SMOKING IS ASSOCIATE WIDE LIVING
IN RURAL AREAS, LOWER EICATION,
LOWER INCOME AND IDENTIFYING AS
A SEXUAL MINORITY, AND WEEKLY OR
MONTHLY KAN--KANA BUSINESS
PROGRAMS USE AND KAN--KANA
BUSINESS PROGRAMS DEPENDENCE ARE
IMRAITER MANNING NATIVE ADULTS
NATIVE AMERICAN ARK DOUBTS,
MIXED RACE ADOWLTS COMPARED TO
WHITE,A DULTS.
AMONG THOSE THAT USE RESEARCH
PRODUCTS, CO USE IS COMMON.
THIS TABLE SHOWS DKRRK CPS
UNPUBLISHED 2015 TO 2019 IS THE
DATA, OF ADULT PAST MONTH
CONTROL CIGARETTE AND CANNABIS
USE.
OVER ALL CANNABIS USE IS
INCREASING AND WE WE'VE SEEN AN
INCREASE IN TREND IN CO USE OF
ALCOHOL AND CANNABIS AND
CIGARETTES AND KAN--KANA
BUSINESS PROGRAMS.
BEYOND HEALTH CO USE CAN HAVE
NEG5 OUTCOMES, FOR EXAMPLE,
CONTROL USE AMONG PEOPLE WHO
SMOKE CIGARETTE SYSTEM SOCKED
WITH LOWER SMOKING QUIT RATES
AND HIGHER RATES OF SMOKING
RELAPSE.
SO UNDERSTANDING BOTH USE AND CO
USE IS IMPORTANT FOR CANCER
PREVENTION AND CONTROL.
WE DO MOT HAVE MUCH DID THEA ON
THE COMBINED HEALTH EFFECTS OF
CO USE.
BUT WE DO KNOW THAT TOBACCO AND
ALCOHOLLOR INDIVIDUALLY HARMFUL,
AS SHEEN HERE, TOBACCO AND
ALCOHOL CAUSE NUMEROUS TYPES OF
CANCER, IN THE U.S. COMBINED
TOBACCO AND ALCOHOL CAUSE 130 OF
CANCER DEATHS.
DATA ON HEALTH EFFECTS OF
CANNABIS ARE LIMITED BUT THE
SMOKING IS THE MOST COMMON MODE
OF CANNABIS ADMINITRATION WITH
78.4% OF KAN--KANA BUSINESS
PROGRAMS USERS 12 AND OLDER
REPORRING THEY HAD SMOKED CANC
BUSINESS PROGRAMS IN THE LAST
YEAR AND WE KNOW INHALING
COMBUSTIBLE SUBSTANCES AND
HARMFUL.
THE APPROXIMATELY SEE
ENVIRONMENT FOR THESE 3
SUBSTANCES AND ALSO CHANGING
RAPIDLY.
SINCE 2012, WE'VE SEEN
LEGALIZATION OF RECREATIONAL
CANNABIS IN 24 STATES, 2
TERRITORIES AND C. BUT POLICIES
MAY NOT HAVE THE INTENDED REACH
OR POPULATIONS EQUALLY, FOR
EXAMPLE, IN OKLAHOMA, MEDICAL
KAN--KANA BUSINESS PROGRAMS USE
IS LEGAL, ZOOM NOTHING THE TO
GRAPHIC ON THE RIGHT FROM A
STUDY PUBLISHED LAST YEAR,
KAN--KANA BUSINESS PROGRAMS
DISPENSARYS IN OKLAHOMA WERE
DISPROPORTIONATELY LOCATED IN
AREAS WITH GREATER DISADVANTAGE
SPECIFICALLY IN AREAS WITH A
HIGHER PERCENTAGE OF UNINSURED
RESIDENTS AND NO FORMACYS AND
SUGGESTING CANNABIS RETAILERS
MAY TAKE ADVANTAGE OF
COMMUNITIES WITH LIMITED
HEALTHCARE ACCESS.
SO SCIENCE BASED POLICY
APPROACHES ARE A KEY PUBLIC
HEALTH TOOL BECAUSE THEY CAN BE
WIDE REACHING AND COST
EFFECTIVE.
THEY HAVE THE POTENTIAL TO
PROMOTE HEALTH EQUITY BY
REDUCING HEALTH DISPARITIES FOR
EXAMPLE, LOWER INCOME
POPULATIONS OFTEN RESPOND MORE
TO TO BACK O TAX AND PRICE
INCREASES THAN HIGHER INCOME
POPULATIONS, OR A POLICY MAY
HAVE UNANTICIPATED OR UNINTENDED
CONESQUENCES OR BE COUNSEL RIGHT
NEGLIGENT WORSENING HEALTH
DISPARITIES FOR EXAMPLE, EVEN
WHEN SMOKE FREE POLICIES ARE IN
EFFECT, SECOND HAND TOBACCO
EXPOSURE IS HIGHER AMONG CERTAIN
GROUPS INCLUDING CHILDREN,
NONHISPANIC PLAQUE BEAM, PEOPLE
WITH LOWER INCOMES AND PEOPLE
WITH LESS EDUCATION.
MORE OVER BECAUSE WE KNOW THAT
PATTERNS OF USE FOR 33
SUBSTANCES CAN BE COMPLEX, WE
ANTICIPATE THAT POLICIES THAT
PERTAIN TO 1 SUBSTANCE WILL
IMPACT USE OF OTHER SUBSTANCES
ON A POPULATION LEVEL THROUGH CO
USE, SUBSIDIARY CONSTITUTION OR
IN OTHER WAYS.
FOR EXAMPLE, IN A HIGH TOBACCO
TAX AREA, IF RECREATIONAL
CANNABIS AND LEGALIZED AND THE
CANNABIS TAXES ARE LOW FOR THE
CONSUMER WE MAY SEE INDIVIDUALS
SUBSTITUTING CANCA BUSINESS
PROGRAMS FOR TOBACCO, THE SPEED
WE SEE THE CHANGE IS EXCITING
AND CONCERNING AND UNDERSCORES
THE NEED TO EVALUATE THE HEALTH
EQUITY IMPACT ON THESE
SUBSTANCES.
FOR THIS SET OF PARS, RESPONSIVE
RESEARCH QUESTIONS MUST ADDRESS
1 OR MORE POLICIES PERTAINING TO
POETIC TOBACCO, WHOLE OR
CANNABIS AND EXPOSURE MIEWOF THE
SHOW ECPOSURE OR USE FOR ALL 3
SUBSTANCES, THERE ARE NO TYPES
OF LIMITS, FOR RESEARCHERS MAY
PROPOSED RANDOMIZED TRIALS,
MODELING STUDIES, THE ONLY
EXCLUSION ON BIOLOGICAL
MECHANISMS OR DISEASE PROCESSES,
SO FOR EXAMPLE, A LABORATORY
BASED EXPERIMENTAL MARKETPLACE
STUDY COULD PROPOSE EXAMINING
TOBACCO FLAVOR RESTRICTIONS WITH
NO FLAVOR CANNABIS RESTRICTIONS
TO UNDERSTAND PURCHASING
BEHAVIOR AND USE, MOST
IMPORTANTLY, THE RESEARCH MUST
EVALUATE THIS IN THE CONTEXT OF
HOW THE POLICY INFLUENCES HEALTH
DISPARITIES AND WOB OR MORE
POPULATIONS EXPERIENCING
DISPARITIES.
AND THESE GROUPS ARE DEFINED BY
NIH AND INCLUDE RACIAL AND
ETHNIC MINORITY GROUPS, PEOPLE
WITH LOW CERTAINLY--CERTAINLY
SES, UNDERSERVED RURAL POP
EULOGIES, SEXUAL AND GENDER
MINORITY GROUPS AND PEOPLE WITH
DISABILITIES, LASTLY THE
RESEARCH MUST BE CONDUCT INDEED
PARTNERSHIP WITH THE COMMUNITY
ORGANIZATION, WHICH WILL HELP
INFORM THE RESEARCH QUESTIONS,
SHAPE THE APPROACH AND
DISSEMINATE FINDINGS.
AS AN EXAMPLE, RESEARCH HAS
SHOWN THAT THERE IS A
SIGNIFICANT ASSOCIATION BETWEEN
NEIGHBORHOOD DISADVANTAGE AND
ALCOHOL AND TOBACCO RETAIL
OUTLET RATES.
ONE COULD WORK WITH COMMUNITIES
TO UNDERSTAND HOW A POLICY
RESTRICTING ALCOHOL RETAIL
LICENSING MAY BE IMPLEMENTED AND
IMPACT USE AND EXPOSURE AMONG
INDIVIDUALS LIVING IN THESE
NEIGHBORHOODS.
THESE FUNDING OPPORTUNITIES
COULD SUPPORT A WIDE RANGE OF
POLICY RESEARCH QUESTIONS WITH
IMPORTANT IMPLICATIONS FOR
CANCER PREVENTION AND CONTROL.
I WANT THANK OUR REVIEW
COMMITTEE FOR THEIR THOUGHTFUL
AND ENCOURAGING FEEDBACK ON THIS
CONCEPT AND I WILL GIVE A BRIEF
OVERVIEW OF THEIR MAJOR COMMENTS
AND HOW WE PLAN TO INCORPORATE
THESE INTO THE FINAL PARS.
FIRST THE COMMITTEE NOTED WE MAY
HAVE OVERSTATED CANNABIS'
ASSOCIATION WITH CANCER AND WE
WANT TO CLARIFY THAT THE
CONSEQUENCES OF LONG-TERM USE OR
HIGHER LEVELS OF USE ARE
UNCLEAR.
USE OF CANNABIS IS INCREASING
AND CO USE OF CANNABIS WITH
TOBACCO AND CONTROL AND ALSO
INCREASING.
WE ARE ALSO--WE WERE ALSO POSING
QUESTIONS TO HELP US THINK
THROUGH THE COMMUNITY
PARTNERSHIP COMPONENT, IN
RESPONSE WE WILL INCLUDE IN THE
PARS EXAMPLES OF COMMUNITY
ENGAGE EXPMENT THAT WE ENCOURAGE
INCLUSION OF WORKFORCE
DEVELOPMENT PLANS AND AN
EXPECTATION OF INVOLVEMENT FROM
CONCEPTION TO DISSEMINATION
WITHIN THE COMMUNITY PARTNERSHIP
LANGUAGE, AND UNRELATEDLY WE
WILL INCLUDE LANGUAGE SIS
SEMESTER NATION TO COMMUNITY
PARTNERS AND COMMUNITIES, SHOULD
BE APPROPRIATE TO THE SCALE AND
SCOPE OF THE RESEARCH QUESTION,
THE STUDY POPULATION AND THE
RESEARCH FINDINGS.
WITHIN THE P A R WE WILL
ENCOURAGE CONSIDERATION OF THE
OVERARCHING CONTEXT AND
POTENTIAL MODERATORS AT PLAY,
FOR EXAMPLE, OTHER POLICIES THAT
MAY BE IN EFFECT, POLICY
ENFORCEMENT, AND EVEN POLICIES
RELATED TO METHODS OF PRODUCT
USE SUCH AS VAPING, OR THE
IMPACT OF POLICY ON THE MODE OF
SUBSTANCE ADMINISTRATION EVEN.
THESE CONTEXTURAL FACTORS OF
IMPORTANCE WILL DEPEND VARY ON
THE RESEARCH PER POST.
AND THE VARIABLES ARE ALCOHOL,
TOBACCO AND CANNABIS EXPOSURE
FOR USE, WE WILL CLARIFY THAT
ALL PROJECTS MIEWOF THE INCLUDE
THIS IN THE PARAND REVIEW
CRITERIA AS APPROPRIATE, WE WILL
ALSO INCLUDE HEALTH HELT OUTCOR
THE PROJECT PROPOSED.
WE WILL SIN THAT SPECIAL
CRITERIA WILL ASK IF THE
DISSEMINATION PLAN IS
APPROPRIATE FOR THE RESEARCH
QUESTION AND THE NATURE OF THE
RESULTS.
THE DISSEMINATION OF PRELIMINARY
EVIDENCE CAN AND SHOULD DIFFER
FROM THE REPEATED FINDINGS, ALSO
EXAM NATION OF A SINGLE
POPULATION EXPERIENCING
DISPARITIES MAY NOT BE THE SAME
AS RECOLLECT POPULATIONS, WE
WILL ALSO INSURE THAT THE REVIEW
CRITERIA ASKS REVIEWERS TO
ASSESS DISPARATE POPULATION
UNDERSTUDY IS A APPROPRIATE.
WE RECOGNIZE THAT THIS IS A
COMPLEX QUESTION, AND AS I
HIGHLIGHTED EARLIER, WE WILL
RELY ON THE NIH DEFINITION OF
POPULATIONS WITH HEALTH
DISPARITIES, AND ENCOURAGE EXAM
NATION OF INTERSECTIONALITY.
THESE PARS WILL INDICATE NCI'S
KAN--KANAER PREVENTION THROUGH
POLICY RESEARCH FOCUSING ON
HEALTH DISPARITIES TO REDUCE THE
USE OF EXPOSURE AND SUBSTANCES
THAT ARE IMPORTANT TO CANCER
PREVENTION, ULTIMATELY HAVING A
LARGE CENTER FOR EXCELLENCE ON
AGING ON USE CANCER RELATED
MORIT AND MORTALITY.
I WOULD LIKE TO OPEN IT UP FOR
COMMENT ANDS QUESTIONS AND
THAIRNG YOU FOR YOUR ATTENTION.
NTHE COMMITTEE REPORT?
, YES, THANK YOU.
THANK YOU DR. KAUFMAN, THAT WAS
VERY NICE PRESENTATION AND I
ALSO THANK YOU SO MUCH FOR BEING
SO RESPONSIVE TO THE COMMENTS TO
THE COMMITTEE.
WE, THE SUBCOMMITTEE MERELY WAS
FULLY SUPPORTIVE OF THIS
PARTICULAR PAR.
WE THOUGHT THAT TOO OFTEN
POLICIES ARE EXAMINED IN
ISOLATION AND NOT CONSIDERED
WHAT THE IMPACT OF THIS POLICY
AND A SPECIFIC SUBSTANCE HAS ON
THE USE OF OTHER SUBSTANCES SO
WE REALLY FELT THIS WAS QUITE
IMPORTANT ESPECIALLY IN THE
CURRENT MARKETPLACE, WHERE WE
HAVE SUCH A CORNUCOPIA OF
DIFFERENT KINDS OF PRODUCTS.
IF YOU EVEN THINK ABOUT STAFF
THOUGH, WE HAVE ALL THESE
DIFFERENT KINDS OF DEVICES
COMING IN DIFFERENT DOSES AND
DIFFERENT FLAVORS, AND YOU ALSO
THINK ABOUT THE CANNABIS MARKET,
TOO, THAT ARE SIMILARLY, THEY
COME IN DIFFERENT TYPES OF THC
CONTAINING PRODUCTS AND WITH ALL
KINDS OF DIFFERENT FLAVORS, SO
WE ARE REALLY IN THIS
ENVIRONMENT WHERE WE HAVE SUCH A
DIVERSITY OF PRODUCTS AND AS A
CONSEQUENCE, CONSEQUENCE WE ALSO
HAVE A RAPIDLY CHANGING
REGULATORY POLICY ENVIRONMENT
AND SO REALLY TAKING A LOOK AT
THESE CAREFULLY AND SEEING ANY
POTENTIAL UNINTENDED
CONSEQUENCES OF 1 POLICY AND HOW
IT AFFECTS THE USE OF OTHERS
SUBSTANCES IS BECOMING VERY
CRITICAL.
IN ADDITION IT'S DR. KAUFMAN HAD
POINTED OUT, THERE IS AN
INCREASE IN TERMS OF COLLEAGUES,
KD--SALLY WAAND SO WE NEED IT ON
GET ON TOP OF THAT AND MINIMIZE
THE TREND TOWARDS HIGHER
PREVALENCE OF MULTIPLE SUBSTANCE
USE.
SO IN SUMMARY WE WERE VERY
SUPPORTIVE.
[INDISCERNIBLE],.
>> VERY SUPPORTIVE.
THE INCLUSION OF CANNABIS IS WE
THOUGHT VERY IMPORTANT BECAUSE
OF ITS FAST RISING USE AND RAPID
EVOLUTION OF POLICY IN
SEVERALITATES, PROVIDES GREAT
OPPORTUNITY FOR WORK TO BE DONE
IN THIS SPACE.
VERY RESPONSIVE OF THESE
THOUGHTS, VERY INTERESTED IN
YOUR DESIRE TO ECHICIZE
COMMUNITY ENGAGEMENT AND I HAD
THOUGHT THAT ALONG WITH THAT,
AND THE OPPORTUNITY TO
EMPHASIZING POSSIBILITIES OF
WORKFORCE DEVELOPMENT WITHIN
THESE COMMUNITIES YOU ENGAGE IN,
THANK YOU FOR PUTTING THAT IN
THERE, OVERALL VERY SUPPORTIVE.
>> KAREN?
>> NETWORK YEAH, AGREE, VERY
SUPPORTIVE AND 1 OF THE THINGS
WE TALKED ABOUT THAT WAS KIND OF
INTERESTING IS WE HOPE FOR THE
POSITIVE, MAYBE WHEN YOU
IMPLEMENT 1 POLICY MAYBE IT WILL
AFFECT THESE BEHAVIORS IN A
POSITIVE WAY BUT IN THE CURRENT
ENVIRONMENT WE SEE THIS REALLY
INTERESTING MIX AND WE TALKED
ABOUT THE FACT THAT WHILE YOU
MAY HAVE AN INSTITUTION FOR
EXAMPLE THAT SAYS WE'RE A
NONSMOKING FACILITY, YOU SEE
PEOPLE LINED UP VAPING BECAUSE
THEY THINK, OH THIS ISN'T
SMOKING, IT'S VAPING.
AND SO, SOMETIMES IT CAN HAVE
THESE SORT OF BACKWARD
UNINTENDED NEG5 CONSEQUENCES
THAT WE DON'T WANT TO SEE SO THE
IMPORTANCE OF ENCOURAGING
INVESTIGATORS TO MEASURE THOSE
KINDS OF THINGS AS WELL IS
NOT'RE WE'RE NOT GOING TO SEE
IT.
RIGHT IN NTHIS IS A RAPIDLY
CHANGING AREA AS PEOPLE POINTED
OUT WITH POLICIES ARE CHANGING
ALMOST DAILY.
OTHER DISCUSSION OF THIS?
TREY?
NI THINK MY MAIN QUESTION IS A
LACK OF UNDERSTANDING OF WHAT
THIS HAS TO DO WITH CANCER, I
UNDERSTAND THE RELATION STUDYING
THE RELATION AMONG STUB STANCES,
BUT THAT'S SOMETHING NIDA MIGHT
STUDY SO I'M TRYING TO
UNDERSTAND WHAT IS THE OUTCOME
HERE THAT'S DESIRED IN TERMS OF
CANCER?
WHAT'S THE POTENTIAL IMPACT IN.
>> RIGHT.
SO, OBVIOUSLY TOBACCO IS THE
LEADING CAUSE OF CANCER DEATHS
IN THE UNITED STATES AND THE
WORLD, AND ALCOHOL IS THE THIRD
LEADING MODIFIABLE LIFESTYLE
FACTOR SO IF WE CAN HAVE THE
BIGGEST BANG FOR OUR BUCK MIGHT
BE A POLICY THAT MIGHT IMPACT
THOSE BEHAVIORS.
IN CONJUNCTION WITH ALCOHOL AND
DO BACK O WE'RE SEEING AN
INCREASE IN CO USE WITH CANNABIS
GIVEN THEITATES THAT ARE
LEGALIZING BOTH MEDICALLY AND
RECREATIONALLY.
SO IF WE CAN CHANGE THESE
LIFESTYLES, THESE BEHAVIORS, WE
SHOULD SEE A REDUCTION IN
CANCER.
SO IT'S CANCER PREVENTION AT THE
HEART OF CANCER PREVENTION.
DOES THAT ANSWER YOUR QUESTION.
>> IS THERE ANY THAT EVIDENCE
CANNABIS CAUSES CANCER.
NTHERE'S 1 STUDY THAT I KNOW OF,
NOT A VERY HUGE HE STRONG STUDY
IS MY UNDERSTANDING OF THE LINK
TBEEN KAN--KANA BUSINESS
PROGRAMS SMOKING AND TESTICULAR
CANCER BUT EVIDENT IS EMERGING
AND VERY MIXED.
>> I WASN'T AWARE OF ANY, AND
COMBINING THOSE 3 THAT YOU WILL
BE DEPLETING YOUR REAL PURPOSE
OF TRYING TO REDUCE ALCOHOL AND
TOBACCO IN COMBINATION BECAUSE
THE PUBLIC WILL THINK, WHY ARE
YOU THROWING IN SOMETHING THAT
ISN'T CAUSING CANCER BUT I
ENYOURCANDIDATES IT AND IT MIGHT
ACTUALLY BE COUNTER PRODUCTIVE.
>> SO I'M GOING TO PIGGYBACK OFF
THAT.
SO I EMBASSY JUST THE KEV DITION
OF TOBACCO IS IT COMBUSTIBLE, SO
LIKE CIGARETTES ET CETERA, THE
SAME CANCER ABOUT CANCER RISK SO
THAT MADE ME THINK MAYBE THERE
SHOULD BE A HIERARCHY IN HERE,
COMBUSTIBLE TOBACCO, ALCOHOL,
CANCER RISKS, THE OTHERS MAYBE
NOT AS MAJOR BUT CO INTERACT
WITH THOSE SO, JUST IN TERMS OF
HOW YOU STRUCTURE, HOW YOU'RE
LOOKING AT DEPEND AND
INDEPENDENT DEPENDENT VARIABLES
MIGHT BE IMPORTANT WHEN YOU
THINK ABOUT THE RFA.
>> GOING TO THE OTHER END OF THE
TABLE.
>> YOU KNOW I CAN BE THE HELP
BUT ARK GREE WITH MY COLLEAGUES
FROM SAN DIEGO BECAUSE I THINK
IT IS JUMPING THE GUN.
BY MAKING AN ARK SUSMGZ THAT
CANNABIS MIGHT HAVE ADDADDATIVE
EFFECT TO LEAD TO CANCER BUT
THAT BEING SAID, I THINK IT'S
GREAT, I THINK IT'S BOLD, I
THINK IT'S A GREAT INITIATIVE,
LET'S JUST TRY IT, YOU NEVER
KNOW WE MIGHT FIND SOMETHING
FROM IT, DO I THINK IT'S
APPROPRIATE FOR WHAT WE'RE
DOING, MAYBE NOT, I AGREE WUIME
OKAY WITH IT, I THINK IT'S
PRETTY BOLD EMPLOY NTHANK YOU.
THIS, I DO KNOW 1 ASSOCIATION
STUDY BETWEEN HEAD AND NECK
CANCER WITH CANNABIS BUT THAT
WAS ALSO WITH HPV INFECTION, BUT
THE COMMENT I WANTED TO MAKE
ABOUT MEASURES, IS THAT FOR THE
FIRST TIME IN OUR CLINICS IN
MEMORIAL SLOAN KETTERRING WE'VE
SEEN A STEEP DECLINE IN VISITS,
BUT FOR THORACIC ONCOLOGY NOT
ONLY IN MEDICAL ONCOLOGY BUT
ALSO IN SURGICAL ONCOLOGY AND
I'VE ANECDOTALLY GONE AROUND THE
COUNTRY TO TALK TO MY COLLEAGUES
AND THAT HAS ALSO BEEN SEEN IN
OTHER COUNTRIES AND THEN MOST
RECENTLY IN BRAZIL AND I TALKED
TO THORS ONTIC ONCOLOGIST AND
THEY'VE SEEN THERE'S A DECLINE
WHERE THERE'S STRICT TOBACCO
ENFORCEMENT SO I THINK THERE'S
PROBABLY AN IMPACT THERE.
NON THAT HOPEFUL NOTE WE'RE
GOING TO ASK FOR A MOTION TO
APPROVE NI WILL SECOND.
>> SECOND.
>> DISCUSSION?
>> NYEAH, I WANT TO POINT OUT
THAT STUDY BY [INDISCERNIBLE]
GILL ESTIMATE THADON AND TRUE
AND IT'S SHOWING THAT EVIDENCE
SMOKING MARIJUANA HAS THE SAME
FOR SMOKE AND DRIVING CANCER BUT
THERE'S A LOT OF DATA SHOWING
THERE'S POTENTIAL FOR THAT TO
HAPPEN THASN'T BEEN TODAYED TO
THAT EXTENT YET, THAT'S THE
ISSUE.
IT'S STUDYING OF MARIJUANA AND
CANCER HAS NOT BEEN DONE TO THE
EXTENT THAT TOBACCO HAS BEEN BUT
IT'S THE SAME BASIC CHEMICALS,
CONSISTING OF OTHER CONCEPT OF
CANC BEER AND TOBACCO SMOKING
DOES TEND TO BE PRESENT.
>> EXPR JUST QUICKLY A REMIND
THERAPY AND IS ACTUALLY STUDYING
THE IMPACT OF POLICY WHICH IS
VERY DIFFERENT FROM KIND OF
LOOKING AT CANCER OUTCOMES.
>> OKAY, WE NEED A VOTE.
ARE THERE ANY NAYS?
ARE THERE ANY ABSTENTIONS?
ONE ABSTENTION.
OKAY, THE LAST 1 NO, NO, WE HAVE
THE RFAs, BUT WE'RE GOING TO
HAVE MODEL CITIZEN MEEK POND WHO
WILL PRESENT THE NCI, SBI, OUR
CONTRACTS WHICH IS DEFINITE FROM
THE OVERALL PROGRAM, AND WE HAVE
A COMMITTEE OF NELSON CEASARY,
RICH AND MYSELF, MOONIQUE TAKE
IT AWAY, PLEASE.
>> SO GOOD AFTERNOON I'M
MONIQUE, ON BEHALF OF THE NCI,
SBIR DEVELOPMENT CENTER, I WILL
PRESENT OUR CONTRACT TOPICS.
SO THE SBIR OFFICE SUPPORTS
INNOVATIVE TRANSLATIONAL
RESEARCH THAT'S CONDUCTED BY
SMALL BUSINESSES, LOCATED
THROUGHOUT THE U.S., AND THE
SBIR TTR PROGRAM IS CONGRESSALLY
MANDATED SET ASIDE SO FEDERAL
AGENCIES WITH R&D BUDGETS THAT
EXCEED A CERTAIN SIZE ARE
REQUIRED TO ADMINISTER THESE
PROGRAMS.
HERE WE CAN UTILIZE THE GRANTS
AND CONTRACT MECHANISMS AND HERE
I'M SHOWING FROM FY2023, ABOUT
12% OF OUR BUDGET WENT TOWARDS
THE CONTRACT MECHANISM, VERSUS
ABOUT 88% THROUGH THE
INVESTIGATION INITIATED GRANTS.
SO THIS DOES FLUCTUATE THOUGH
FROM YEAR TO YEAR AND WE'VE GONE
ANYWHERE 25% ALMOST 30% FOR
CONTRACKS.
SO WITH THE CONTRACT MECHANISM,
WE CAN ISSUE VERY NARROWLY
FOCUSED TOPICS WITH SET
MILESTONES AND PRODUCT
DEVELOPMENT, DELIVERABLES THAT
NCI DEFINES, AND THEN WE LOOK AT
THE OVERALL SUCCESS RATES FOR A
NUMBER OF PROPOSALS THAT WE
AWARD, I DO WANT TO NOTE THAT
OUR CONTRACKS PROPOSALS ARE
QUITE COMPETITIVE AND
AROUND--I'M SORRY AROUND 15%
SUCCESS RATE FOR CONTRACTS, THIS
IS COMPARABLE TO OUR GRANDS
PORTFOLIO WHERE WE SEE SLIGHTLY
LOWER NUMBERS AROUND 8-10%
SUCCESS FOR OUR EARLY STAGE
PHASE 1 PROJECTS AND WE SEE
SLIGHTLY HIGHER SUCCESS WITH OUR
AGREANCE WITH OUR LATER STAGE 2
PROJECTS AND THEN I DID JUST
WANT TO KNOW THAT THIS IS NOT
AFFECT THE RPG POOL THIS, IS THE
CONGRESSALLY MANDATED SET ASIDE.
SO WE FUND BUSINESSES THROUGH
THE CONTRACT MECHANISM FOR
SEVERAL REASONS, 1 IS SOMETIMES
TO ADDRESS A NEED FROM THE
CANCER COMMUNITY BUT OFTEN IT'S
TO STIMULATE RESEARCH AND
PRODUCT DEVELOPMENT IN A CERTAIN
AREA SO THIS COULD BE A NEW
EMERGING AREA OR IT COULD BE
MEDICALLY CHALLENGING AREA,
SOMEWHERE WITH A HIGH OR
SIGNIFICANT UNMET MEDICAL NEED.
LASTLY WE ALSO USE THIS TO
ADDRESS CERTAIN PATIENT
POPULATIONS OR MAYBE CERTAIN
CANCER INDICATIONS THAT ARE
UNDERREPRESENTED IN OUR IMRANTS
PORTFOLIO.
SO BEFORE I PRESENT THE TOPICS,
I WANT TO GIVE A SHORT SUMMARY
TO GET THIS FOR THE PROGECS EACH
YEAR SO IN THE PAUL WE SOLICIT
TOPIC IDEAS FROM NCI DIVISIONS
DIVISIONS
AND OFFICES AND CENTERS.
IN OF THE PATHWAY GIVES WE'VE
ALSO COLLABORATE WIDE FDA, TO
GET THEIR RECOMMENDATIONS AS
WELL.
SO FOR FY25 WE RECEIVED 15 TOPIC
SUBMISSIONS, EACH OF THESE
SUBMIG DUALAS, THE TOPIC AUTHORS
ARE REQUIRED TO DO A PORTFOLIO
ANALYSIS THAT DETAILS NOT ONLY
THE NCI FUNDING BUT ALSO THE NIH
FUNDING SBIR AND NONSBIR IN
THESE AREAS.
THESE THEN GO TO OUR TECHNOLOGY
ADVISORY GROUPS AND WE HAVE 2
GROUPS THAT ARE COMPOSED OF
SUBJEK MATTER EXPERTS ACROSS NCI
TO IN ADDITION TO OUR PROGRAM
DIRECTORS IN THE SBIR OFFICE.
FROM THERE SIGNIFICANT WORK IS
DONE ON THIS STAGE ACROSS NCI AS
WELL AS TAG REVOWERS PROVOIDING
FEEDBACK AND IMPROVE AMS TO THE
TOPICS AT THIS POINT.
SO BEFORE I BEIMIN THE TOPICS, I
HAVE 13 THIS YEAR THAT WE WILL
BE PRESENTING FOR CONSIDERATION,
ALL 13 HAVE BEEN APPROVED BY
SBL, AND I WILL BE SHOWING THEIR
TOPIC TITLE.
THE NCI DIVISION OFFICER THAT
CONTRIBUTED AND WROTE THE TOPIC
AS WELL AS OVERALL GOAL AND THE
NATIONAL CANCER PLAN THAT WE
FEEL THAT THE TOPIC SUPPORTS.
SO I'LL BEGIN THE 7 THERAPEUTICS
RELATED TOPICS FOR CONSIDERATION
WITH THE NOVEL CANCER VACCINES
WE HOPE IT SUPPORTS EARLY STAGE
VACCINE DEVELOPERS THAT WILL
LEAD TO SAFETY AND IMPROVED
EFFICACY OF RNA BASED CANCER
VACCINES AND HOPEFULLY OVERCOME
LIP I MUTATIONS OF THE LIPIT
NANO PARTICLE DIFFERY SYSTEM.
THE SECOND THERAPEUTIC TOPIC IS
THE DEVELOPMENT OF CANCER
PREVENTION AGENTS SO THERE'S
ACCUMULATING PRECLINICAL
EVIDENCE SUGGESTING THAT
VACCINES AND OTHER IMEULOGY
BASED INTERVENTIONS CAN INDUCE
HOST IMMUNE RESPONSES AND
PROVIDE EFFICACY, SO HERE THE
TYPE OF CANCER AND OPEN TO THE
OFFER WITH THE EXCEPTION OF
VIRUS INDUCED CANCERS WITH THE
LONG-TERM GOAL BEING TRANSLATION
OF EARLY WORK AND IMMUNO
PREVENTION SPACE.
THE INCOME TOPIC IS SYNTHETIC
MICROBES FOR IMMUNOLOGY
THERAPIES.
HERE THE GOAL TO DEVELOP MIKE
ROBIAL BASED THERAPY FOR
CLINICAL USE.
THE PROPOSED DEVELOPMENTMENTAL
AGING COULD BE PROPOSED AS
SINGLE AGENT OR IN COMBINATION
WITH EXISTING IMMUNE ONCOLOGY
TREATMENTS, HOWEVER, ANY ONCO
LYTIC VIRUSES OR NONSYNTHETTIC
MICROORGANISMS WOULD BE
CONSIDERED OUT OF SCOPE HERE
EMPLOY THE NEXT TOPIC WILL
SUPPORT THE DEVELOPMENT OF HPV
RELATED PRECANCKER.
SO WE KNOW THAT HPV RELATED
CANCERS AFFECT MILLIONS OF
PEOPLE WORLD WIDE AND THERE'S
ONGOING IMPORTANT EFFORTS FOR
SCREENING AND PROPHYLACTIC
APPROACHES BUT THIS TOPIC HERE
FOCUSES ON NEW TREATMENTS THAT
CAN EITHER PREVENT PROGRESSION
OF IDENTIFIED CHRONIC HPV
INFECTIONS OR INDUCE REGRESSION
OF PRECANCEROUS LESIONS.
THE NEXT TOPIC SUPPORTS
TRUCKS--THEN TRICIAN,
INTERVENTIONS FOR REDUCING
CANCER RELATED SYMPTOMS THAT WE
KNOW PEOPLE CAN EXPERIENCE WHEN
RECEIVING CANCER TREATMENT.
SO MILD NUTRITION CAN NOT ONLY
REDUCE A PATIENT'S QUALITY OF
LIFE BUT IT CAN ALSO LEAD TO
SUBOPTIMAL TREATMENT OUTCOMES SO
HERE'S EXAMPLE OF PRODUCTS THAT
CAN BE DEVELOPED, INCLUDE
NUTRITIONAL AGENTS OR MEDICAL
FOODS.
THE NEXT TOPIC CERTAINTIES
DEVELOPMENT OF DRUG LOADED CARE
YEAR PARTICLES FOR IMPROVED ORAL
THEREFOREY OF COLON CANCER
PREVENTION AGENTS.
HERE OFFERS SHOULD DEVELOP A
NOVEL DELIVERY SYSTEM, THAT
PROTECTS AN ORORRAL AGENT FROM
THE GASTROINTESTINAL ENVIRONMENT
AND LEADS TO ENHANCED HALF LIVE
AND ENVIRONMENT IN THE
COLORADOON.
THIS OPEN MEETINGIC'S OPEN TO
DIFFERENT CARRIER PARTICLES, BUT
THE NEW SYSTEM SHOULD DEMON
TRAIT THIS PROLONGED
CONCENTRATION IN THE COLON.
AS WELL AS HAVE VERY LIMITED
SYSTEM TEMMIC SIDE CENTER FOR
EXCELLENCE ON AGINGS.
THE LAST THERAPEUTICS TOPIC FOR
CONSIDERATION TODAY IS THE
DEVELOPMENT OF ANTIBODY DRUG
CONJUGATES.
AS RADIO DIAGNOSTICS FOR
TREATING CANCER MUCH THE GOAL IS
TO IMPROVE EFFICACY IN 2 WAYS,
THE FIRST IS TO ADD A
DINUCLEOTIDE CONJUGATE THAT
ALLOWS FOR WHOLE BODY IMAGING,
THE SECOND WAY IS TOEDAAD
THERAPEUTIC RADIO NUCLEOTIDE SO
THE END PRODUCT THAT WE'RE
LOOKING AT IS ADC THAT CAN
COUPLE DIAGNOSTIC CAPABILITIES
WITH BOTH CHEMICAL AND RADIATION
BASED TREATMENTS.
SMRKS SO THE NEXT 2 TOPICS FALL
UNDER CLINICAL DIAGNOSTICS AND
MOLECULAR ANALYSIS, I WILL BEGIN
WITH POINT OF CARE DETECTION
AGAINST ANTIBODIES OF HPV 16,
18, E6 AND 7 ONK O PROTEINS, SO
THE PRODUCT ENVISIONS HERE IS A
SIRROLOGY BASED RAPID TEST FOR
SCREENING AND EARLY DETECTION OF
HPV RELATED CANCERS THAT IS BOTH
AFFORDABLE AND CAN BE USED
OUTSIDE OF CLINICAL SETTING.
WE BELIEVE A PRODUCT LIKE THIS
COULD INCREASE ACCESS TO HPV
TESTING FOR HIGH RISK POP
EULOGIES INCLUDING PEOPLE LIVING
IN COUNTRIES WITH LIMITED
MEDICAL INFRASTRUCTURE.
THE NEXT TOPIC IS ANOTHER POINT
OF CARE TECHNOLOGY, FOCUSED HERE
ON GASTROINTESTINAL TRACK CANCER
FOR PREVENTION AND EARLY
DETECTION.
WHILE SOME PROGRESS HAS BEEN
MADE WITH GI CANCERS WE KNOW
DISPARITIES AND DISEASE BURDEN
AND MORTALITY EXISTS FOR SOME
MINORITY COMMUNITIES AS WELL AS
RURAL POPULATIONS.
SO THE END PRODUCT DEVELOPED
HERE SHOULD BE BOTH COST EFFECT
AND I HAVE HAVE HIGH SENSITIVITY
AND SPECIFICITY WHICH WILL
HOPEFULLY HELP REDUCE THESE
BARRIERS TO TESTING.
NEXT WE HAVE 2 INFORMATION
TECHNOLOGY AND DIGIT AT HEALTH
TOPICS FOR CONSIDERATION THE
FIRST TOPIC IS THE DEVELOPMENT
OF DIGITAL BIOMARKERS FOR
CLINICAL CANCER CARE.
SO THERE'S A RANGE OF DIGITAL
HEALTH TECHNOLOGIES THAT CAN
MONITOR AND COLLECT PATIENT
INFORMATION IN REALTIME, AND THE
IDEA HERE IS TO INCORPORATE THIS
INFORMATION, INTO A DIGITAL
BIOMARKER THAT CAN SERVE AS A
REMOTE INDICATOR OF CERTAIN
BIOLOGICAL OR PATHOGENIC
PROCESS.
THE NEXT TOPIC IS DIGITAL TWIN
SOFTWARE FOR OPTIMIZATION OF
CANCER RADIATION THERAPY EMPLOY
SO A DINLITTAL TWIN IS A VIRTUAL
MODEL SYSTEM CAN BE USE INDEED A
WIDE VARIETY OF WAYS BUT HERE,
FOR EXAMPLE, IN THE CONTEXT OF
RADIATION THERAPY, WE ENVISION
DIGITAL TWIN OF THE PATIENT USED
BY A PROVIDER TO ARK ASSESSES
AVAILABLE THERAPIES AS WELL AS
POETIC TEBTIAL COMBINATIONS OF
THERAPY, AND HELP GUIDE THEIR
CLINICAL DECISION MAKING PROCESS
AND PROVIDE INDIVIDUALIZED
TREATMENT FOR THEIR PATIENT.
NOW I'LL MOVE ON TO MEDICAL
DEVICES AND WE HAVE 1 TOPIC
TODAY, ENTITLED WEARABLE
TECHNOLOGIES TO FACILITATE
REMOTE MONITORING OF CANCER
PATIENTS FOLLOWING TREATMENT.
THE IDEA HERE IS TO BUILD UPON
CURRENT WEARABLE DEVICE
CAPABILITIES TO PROVIDE
CLINICALLY RELEVANT INFORMATION
TO A PATIENT'S CARE TEAM.
SO THE LAST TOPIC FOR
CONSIDERATION TODAY FALLS UNDER
OUR RESEARCH TOOLS CATEGORY AND
IT'S ENTITLED ADVANCED MATERIALS
TO IMPROVE CANCER MODELING, FOR
RESEARCH.
SO HERE INITIALLY THE PRODUCTS
THAT ARE ENVISIONED WOULD BE
BIOMATERIAL BASED TOOLS THAT CAN
BE USED FOR BASIC AND
PRECLINICAL CANCER RESEARCHERS
BUT LONGER TERM GOAL WOULD BE TO
PROVIDE THE CLINICAL RESEARCH
COMMUNITY WITH IMPROVED INVITRO
MODELS THAT COULD COMPLEMENT OR
POTENTIALLY REPLACE IN VIVO
MODELS.
SOPHISTICATED LASTLY TODAY, I
WANT TO END BY HEIGHT LIGHTING
THAT THE SBIR CONTRACT MECHANISM
HAS SUPPORTED MANY SUCCESSFUL
COMMERCIALIZATION, SUCCESSFUL
COMMERCIALIZATION OF PRODUCTS
AND REALLY ACROSS THE SPACE
DIAGNOSING MONITORING, TREATING
PATIENTS WITH CANCER, HERE I'M
HIGHLIGHTING CIVATECH AND IT'S A
PRODUCT USED TO TREAT TUMORS
ORIGINALLY SUPPORTED BY CONTRACT
XTHEY WENT TO TO HAVE 2 FOLLOW
ON PRODUCTS TO CIVASTRING AND
CIERK VADERM AS WELL.
AND THESE ARE USED THROUGHOUT
THE COUNTRY.
MOSTLY I WANT TO CONCLUDE WE DID
AN ANALYSIS OF THE CONTRACTS
PORTFOLIO AS A WHOLE AND WE
FOUND 30 PSYCHOFIZZISTS OF
CONTRACTS DO RESULT IN
COMMERCIALIZED PRODUCTS FOR
PATIENTS AND THAT WAS SIMILAR
FOR OUR GRANTS PORTFOLIO AS
WELL.
SO WE CONSIDER THE CONTRACKS TO
BE AN IMPORTANT MECHANISM WE CAN
USE TO FUND INNOVATIVE PRODUCTS
FOR PATIENTS AND INSURE THAT WE
ARE REACHING EVERYONE ACROSS THE
COUNTRY SO THANKS.
HAPPY TO ANSWER ANY QUESTIONS
AND I DO WANT TO NOTE THANKS TO
THE BSA SUBCOMMITTEE FOR REALLY
REVIEWING.
IT WAS A LOT OF TOPICS TO REVIEW
AND REALLY APPRECIATE ALL YOUR
FEEDBACK AND COMMENTS.
>> NELLY WANT TO START?
>> RICH, YOU GO FIRST.
>> ALL RIGHT, THANK YOU DR. POND
FOR YOUR EXCELLENT PRESENTATION,
MY FELLOW REVIEWERS AND SHELLY
AND NELLY AND I WERE SUPPORTIVE
OF THE 13 SBIR PROPOSALS.
ESPECIALLY WANTED TO COMEBD YOU
ON THE EMPHASIS ON CANCER
PREVENTION.
OUR QUESTIONS FOR THE GROUP
MAINLY WERE LESS ABOUT THE
INDIVIDUAL PROPOSALS BUT MORE
ABOUT THE PROCESS AND DR. POND
NICELY DRIEBED THE PROCESS FOR
YOU.
SO WITH THAT, AND KNOWING THAT
WE ARE SUPPORTIVE, I WILL TURN
IT OVER TO MY FELLOW REVIEWERS
FOR COMMENTS?
NELSON CEASARY?
>> ALL RIGHT, SMALL TECHNICAL
DIFFICULTIES, AS WE TALK ABOUT
THIS, I JUST WANT TO SAY THIS
WAS A PLEASURE TO REVIEW.
I THINK WE HAD A LOT OF GREAT
QUESTIONS, AND WE UNDERSTAND
THAT THERE IS LIKE STILL THE
OPPORTUNITY PROPROPOSE FOR ABOUT
80% OF THE SBIR FUNDS, OPEN,
OPEN IDEAS BUT AT THE SAME TIME
THE TEAM HAS COME TOGETHER TO
SUGGIEST REALLY IMPACTFUL NEW
AREAS AND I'M PARTICULARLY
EXCITED ABOUT A LOT OF THEM IN
THE SPACE OF CANCER PREVENTION,
I THINK IS VERY THOUGHTFUL AND
OF COURSE AI.
SO, THANK YOU.
I THINK THIS WAS A VERY WORTH
WHILE AND THOUGHTFUL PROCESS,
AND I'M VERY SUPPORTIVE OF IT.
>> IT WAS VERY ENJOYABLE AND WE
ASK ABOUT YOU KNOW EXTERNAL
INPUT AND I THINK THAT THERE IS
EXTERNAL INPUT THROUGH A NUMBER
OF WAYS TO THE SBIR PROGRAM BUT
ALSO THE REVIEW IS DONE BY AN
EXTERNAL GROUP SO I THINK WELL'S
PLENTY OF OPPORTUNITIES, VERY
INTERESTING SET OF CONTRACTS.
DISCUSSION?
NTHAIRNG YOU FOR THE
PRESENTATION AND THESE ARE ALL
TERRIFIC PROPOSALS AND I THINK
IT'S NICE TO SEE THAT AT LEAST
ONE-THIRD OF THESE EVENTUALLY GO
TO COMMERCIALIZATION.
WHAT I WAS GOING TO ASK IS AS A
SURGEON EVEN IN THE BACK UP
SLIDES SHOWS THAT LESS THAN 5%
GO TOWARDS SURGICAL TECHNOLOGY
AND COVID VOICE, 4 MONTHS AGO.
NNO WORRIES.
>> THE REASON I'M ASKING IS WHEN
SURGEONS IN THE WAY, THEY WANT
LOW COST TOOLS AND IT'S HARD TO
GET SBIR FOR A SURGICAL TOOL SO
MOST OF THE THEM GRAVITATE
TOWARDS INDUSTRY AND THOSE DON'T
TEND TO BE CHEAP.
SO 1 SUGJOAOF THION I MIGHT MAKE
IS LOOK OUT FOR SURGICAL TOOLS
THAT ARE OUT THERE AND FUNDED.
>> OKAY, YEAH, GREAT SUGGESTION.
YES ISSUES THE SLIDE YOU'RE
REFERRING TO IS FROM 1 YEAR, WE
DON'T DICTATE WHAT PERCENTAGE OF
FUNDING GOES TOWARD THERAPEUTIC,
SURGICAL TOOLS, ET CETERA IT'S
DETERMINED BY THE INNOVATIVE
IDEAS AND THE TOP SCORING
INNOVATIVE IDEAS THAT COME FROM
THE EXTERNAL COMMUNITY AND
INVESTIGATORS SO, BUT 1 WAY THAT
WE CAN TRY TO BOLSTER CERTAIN
AREAS IS THROUGH A CONTRACT
TOPIC.
WE DO HAVE METRICS THAT SHOW
THAT IF WE ISSUE A CONTRACT
TOPPER FOR 1 YEAR, WE HAVE
SEVERAL EXAMPLES WHERE THE NEXT
4 TO 5 YEARS WILL ACTUALLY
DOUBLE THE MEMBER OF
APPLICATIONS WE GET THROUGH OUR
GRANT MECHANISMS, SO, YEAH, THAT
WOULD BE--THAT'S AN EXCELLENT
SUGGESTION FOR A FUTURE TOPIC WE
CAN CONSIDER.
>> AND THE REASON BEING, YOU
KNOW, EVERY YOU KNOW
[INDISCERNIBLE] HAS A VALUE OF
DEBT AND MOST SURMICAL TOOL FIST
THEY DON'T GET THIS OR INDUSTRY
SUPPORT THEY END UP DYING THERE.
>> THAICHG YOU.
NANY OTHER POINTS OF DISCUSSION
NTHIS MAY BE A NAIVE QUESTION SO
I'M LOOKING AT ADCs, I WASN'T
WHAT MY IMPRESSION THAT ADCs
WERE NOT INTERPRET WELL FROM A
CLINICAL APPLICATION SUCCESS
PERSPECKIVE, IS THE IDEA OF THE
SBIR FOR ADCs TO SEE IF THIS
IMPROVES THEIR [INDISCERNIBLE].
SOMEONE ON THE PANEL CAN--WHAT
DOES THE SBIR DO FOR ADCs IN
THESE?
>> SO THIS IS A CONTRACT AND
IT'S VERY SPECIFIC.
YOU WANT TO COMMENT ON THAT.
>> SURE, SURE.
SO I THINK THE CONTRACT OFFERS
THE WHYED IS THAT IT WOULD
COMBINE IMAGING AS WELL AS
RADIATION THERAPY ALONG WITH THE
CURRENT CYTOTOXIC AGENT THAT YOU
NOTED HAS HAD MIXED RESULTS IN
CLINIC AND SO HOPEFULLY, THAT,
YOU KNOW THAT KNOWLEDGE DOESN'T
EXIST AND HOPEFULLY INMODEL
CITIZENIVATING IN THOSE 2 WAYS
WOULD IMPROVE.
>> [INDISCERNIBLE].
OKAY, CAN WE HAVE A MOTION
DISCUSSION?
MOTION TO APPROVE?
NMOTION TO APPROVE NSECOND.
>> ANY DISCUSSION?
YES IN NETWORK OKAY, WE NEED TO
BE QUICK, WE HAVE 1 MORE.
>> WELL I JUST WANT TO KNOW IS
IT THE PRESENTATIONS GIVEN,OOSE
NOT REALLY CLEAR WHAT IMPACT HAS
BEEN IN TERMS OF NUMBER OF
ACTUAL PATIENTS HAVING BEEN
TREATED WITH THE PRODUCT, WHAT
STATES IT'S USED IN ET CETERA.
IS THAT SOMETHING THAT COULD BE
PULLED TOGETHER AND PRESENTED SO
THAT WE HAVE A BETTER, REAL
IMPACT ON COMMUNITY AND HOW THE
COMMUNITY THROUGHOUT THE UNITED
STATES BOTH THE SCRIBERS AND THE
PATIENTS, THOSE KINDS OF DETAILS
USUALLY IN THE 5-10 K, THE
COMPANY WILL OFTEN HAVE THAT AS
PUBLIC INFORMATION ANYWAY.
>> I THINK WE CAN ASK FOR THAT
FOR NEXT YEAR NSURE.
>> IF I COULD JUST COMMENT, WE
HAVE DONE THAT ANALYSIS FOR THE
PAST 3 YEARS, TRYING TO MEASURE
PATIENT IMPACT, EXACTLY AS YOU
MENTIONED AND WE HAVE FOUND THAT
WE HAD 36 REGULATORY APPROVALS
THAT HAVE COME FROM TECHNOLOGIES
THAT RECEIVED SBIR FUNDING WITH
OVER 2/3RDS OF THESE APPROVALS
BEING FDA APPROVALS SO FROM THAT
MEASURE, WE FEEL THAT THAT IS 1
WAY TO MEASURE THESE
TECHNOLOGIES ARE REACHING
PATIENTS.
>> WE NEED TO HAVE A VOTE NOW NI
DON'T QUITE UNDERSTAND THAT
BECAUSE THINGS ARE OFTEN
APPROVED AND YOU NEVER GET TO
PATIENTS THEY GET SOLD OFF,
THERE'S A LOT OF THINGS THAT
HAPPEN TO APPROVED PRODUCTS.
>> WE NEED TO VOTE NOKAY, ARE
THERE ANY NAYS ON THE SBIR
CONTRACK?
>> ANY ABSTENTIONS.
ONE ABSTENTION.
IT'S UNANIMOUS FROM THE BSA.
GOOD AND NOW WE HAVE
[INDISCERNIBLE] PRESENTING ABOUT
THE COME BIENED RFA REISSUES?
NTHANK YOU FOR THE TIEBT TO
PRESENT THE PROGRAM
ANNOUNCEMENTS WITH SPECIAL
RECEIPT OF REVIEW FROM ALL THE
DEVISION OFFICERS AND CENTERS OF
NCI.
>> CAN YOU MOVE THE SLIDE
PLEASE, I WILL CALL IT FUNDING
OPPORTUNITIES FOR THIS TALK AND
I WILL PRESENT EVERYTHING IN 2
SLIDES, SO BEAR WITH ME.
CAN YOU GO TO THE NEXT SLIDE,
PLEASE.
OR SHOW ME HOW TO DO IT.
>> OKAY, WONDERFUL THANK YOU.
SO FROM LEFT TO RIGHT, WE ARE
STARTING WITH THE FIRST COLUMN
BEING THE DIVISION OFFICER
CENTER, CURRENT FUNDING
OPPORTUNITY NUMBER, TITLE OF THE
FUNDING OPPORTUNITY, ACTIVITY
CODES, FIRST WHEN IT WAS FIRST
ISSUED, THE DATE OF ISSUE, THE
FOR THE CURRENT FUNDING
OPPORTUNITY WHEN IT'S EXPIRING
THE NUMBER OF ISSUANCES, NUMBER
OF GRANTS AWARDED FOR THE
CURRENT ISSUANCE AND SOME NOTES,
AND I WILL TALK ABOUT THE NOTES
ELEMENT SO THE FIRST 3 FUNDING
TIEWPTS ANNOUNCE WANTS I'M GOING
TO TALK IS FROM THE CENTER FOR
REDUCING CANCER HEALTH
DISPARITIES, THE VERY FIRST 1 IS
NCI MENTORED CLINICAL SCIENTISTS
RESEARCH CAREER DEVELOPMENT TO
PROMOTE DIVERSITY AND 1 IS WITH
CLINICAL TRIAL REQUIRED AND THE
SECOND 1 IS CLINICAL TRIAL NOT
ALLOWED AND BOTH ARE K08.
AND IF YOU GO FROM LEFT TO RIGHT
AS I SAID, IT WAS FIRST ISSUED
IN 1997 AND THERE HAVE BEEN 9
PRIOR ISSUANCES IN THE CURRENT
FUNDING OPPORTUNITY THEY'RE
HAVING 4 AWARDS AND FOR--DEITION
HAS NOT BEEN MADE FOR FISCAL
YEAR 2024 YET.
THE SECOND 1 CREFRESH YOUR
RECOLLECTION CHD IS FOR NKRRK I
MENTORED RESEARCH SCIENTIST
DEVELOPMENT TO PROMOTE
DIVERSITY, K01 GRANT, THE 2 OF
THEM ARE AGAIN, INDEPENDENTLY
CLINICAL TRIALS, NOT ALLOWED,
AND CLINICAL TRIALS REQUIRED,
FIRST ISSUED IN 1998, AND THE
NUMBER OF ISSUANCES HAVE BEEN 10
AND CURRENTLY THERE HAVE BEEN 2
AWARD ANDS DECISION FOR 2024 HAS
NOT BEEN MADE.
THE THIRD 1 FOR CRCHD IS NCI
TRANSITION CAREER DEVELOPMENT
AWARD TO PROMOTE DIVERSITY,
AGAIN CLINICAL TRIALS NOT
ALLOWED AND CLINICAL TRIALS
REQUIRED, IT'S A K22.
FIRST ISSUED IN 2001 AND THE
EXPIRATION AND THE CURRENT 1
THAT'S ISSUED IN 2021, THE
NUMBER OF PRIOR ISSUANCES IS 9
AND THE NUMBER OF GRANTS AWARDED
IS 2 ISSUE THE AGAIN THE
DECISION FOR THE CURRENT FISCAL
YEAR HAS NOT BEEN MADE.
THE NEXT 2 IN BLUE ARE FROM
DIVISION OF CANCER BIOLOGY, THE
FITTER 1 FROM THE CANCER BIOLOGY
IS BASIC RESEARCH IN CANCER
HEALTH DISPARITIES RESEARCH.
WE HAVE THE 3 RO-1, R21 AND RO3
ACTIVITIES CODES.
INITIALLY SHOOTING 2015 AND THE
NUMBER OF PRIOR ISSUANCE FOR THE
OTHER 1 IS 2, FOR H214 AND RO3
IS 0, AWE LOOT THERE WERE NO
PRIOR ISSUANCES AND THE NUMBER
OF GRANTSA, WAKED TOTAL IS 21.
THE SECOND INITIATIVE FROM
CANCER OF BIOLOGY IS METASTASIS,
RESEARCH NETWORK OR MECHANISM IF
YOU THE RESEARCH PROGECS.
THIS IS A COOPERATIVE AGREEMENT
UO1 FIRST ISSUED IN 2022, AND
THERE HAVE BEEN 2 IMRANTS
AWARDED AND THEY ARE IN THE
PROCESS OF NOMINATING THROW
APPLICATIONS IN ROUND 2 IT SAYS.
THE NEXT 3 INITIATIVES ARE FROM
DIVISION OF CANCER CONTROL AND
POPULATION SCIENCES, THE FIRST 1
IS THE DISSEMINATION AND
IMPLEMENTATION RESEARCH AND
HEALTH, AGAIN IT IS R01, R21
XR03.
FIRST ISSUED IN NEEN 1999 AND
THE NUMBER OF PRIOR ISSUANCES
FOR THIS INITIATIVE IS 9 FOR
R01, AND 8 FOR R03, THERE HAVE
BEEN 4 AWARDS MADE IN THE
CURRENT ISSUANCE OF FUNDING
OPPORTUNITY 2 ARE PENDING, THE
TOTAL AWARDS FROM MIRE ISSUANCE
IS 56.
THE SECOND INITIATIVE FROM DCCPS
IS CANCER EPIDEMIOLOGY COHORT
BUILDING THE NEXT GENERATION OF
RESEARCH COHORTS, COOPERATIVE
AGREEMENT AND THE FOLLOWING 1 IS
RESEARCH OPPORTUNITIES FOR
ESTABLISH CANCER EPIDEMIOLOGY
COHORT STUDIES AGAIN COOPERATIVE
AGREEMENT, FIRST ISSUED IN 2022,
AND THE NUMBER OF GLANCES ON THE
CANCER EPIDEMIOLOGY COHORTS
BUILDING THE NEXT GENERATION
COHORTS, THE OTHER 1 IS 1 GRANT.
THE FINAL 1 FROM DCCPS IS
CLINICAL CHARACTERIZATION OF
CANCER THERAPY INDUCED ADVERSE
EQUALLY AND MECHANISM BASED
INTERVENTIONAL STRATEGIES IT'S
AN RO-1 ACTIVITY CODE INITIALLY,
SHOWED IN 2019, AND 1 PRIOR
ISSUANCE WITH 12 GRANTS AND
THERE WERE 9 AWARDS FROM THE
PRIOR ISSUANCE.
MOVING ON, THERE ARE 3
INITIATIVES FROM DIVISION OF
CANCER PREVENTION ISSUE THE
FIRST 1 BEING MECHANISMS THAT
IMPACT CANCER RISK AFTER
BARIATRIC SURGERY, WE HAVE AN
R01 AND R21 ACTIVITY CODES FIRST
ISSUED IN 2021 CAN NAY HAVE BEEN
NO AWARDS.
THE SECOND INITIATED FROM THE
DIVISION OF CANCER PREVENTION
IS, CANCER PREVENTION AND
CONTROL CLINICAL TRIALS PLANNING
GRANT PROGRAMS, WE HAVE AN
RTHROWN--EQUALLY ARE AND I U34
U-BEING THE COOPERATIVE
AGREEMENT PLANNING GRANT FIRST
ISSUED IN 2022 AND THE NUMBER OF
IMRANTS FOR L31 IS 1 AND 3 FOR
THE U34S AND THE FINAL 1 FROM
DIVISION OF CANCER PREVENTION IS
UTILIZING THE FROSTED LUNG COAL
O RECTIFIEDOR AND BIOSPECIMENS
TO BRIDGE GAPS IN CANCER
ETIOLOGY AND EARLY DETECTION
RESEARCH EMPLOY WHICH IS A UO1
AGAIN, COOPERATIVE AGREEMENT
FIRST ISSUED IN 2012 AND THIS
HAVE BEEN 3 ISSUANCES AND
AWARDED IN THE CURRENT FUNDING
TIEWPTS 19.
WE HAVE 5 INITIATIVES FROM
DIVISION OF CANCER TREATMENT AND
DIAGNOSIS, THE FIRST 1 BEING
TOWARDS TRAMSALATION OF NANO
TECHNOLOGY, CANCER INTERVENTIONS
OR TTNCI, WHICH IS AN RO-1.
THE FIRST ISSUANCE WAS IN 2020
WITH 1 PRIOR ISSUANCE AND 6
AWARDS, THE SECOND 1 FROM DCTD
WOULD BE MOLECULAR IMAGING OF
INFLAMMATION AND CANCER AND RO-1
ACTIVITY CODE, FIRST ISSUED IN
2021 WITH 2 AWARDS, THE THIRD 1
FROM DCTDs INTEGRATION OF
IMAGING AND FLUID BASED TUMOR
MONITORING AND CANCER THERAPY,
RO-1 AGAIN, WITH 1 PRIOR
ISSUANCE AND 5 AWARDS.
AND THE FOURTH 1 IS EXPLORATORY
DEVELOPMENTAL BIOENGINEERING
RESEARCH GRANTS WHICH ARE CLIN
TRAL NOT ALLOWED AND BOGS OF
WHICH ARE ACTIVITY CODES FIRST
ISSUED IN 2019 AND PRIOR ASHANCE
IS 2 ANY FOR THE CLINICAL TRAIL
LOCKED AND LOADED HAVE BEEN 17
GRANTS AWARDED AND CUT IN THE
FUNDING OPPORTUNITY AND THERE
HAVE BEEN 7 AWARDS AWARDED.
AND BIOSPECIMEN APPROACHES INTO
CLINICAL ASSAY WITH DEVELOPMENT,
A UO1 ACTIVITY CODE WOOPRATIVE
AGREEMENT IN 20 SCWEAN WITH
PRIOR INSTANCES, THERE HAVE BEEN
6 AWARDS MADE AND 2 ARE PENDING.
FINALLY FROM OFFICE OF CANCER
CENTERS A P30 ACTIVITY CODE THE
FIRST 1, THE FIRST ISSUE OF THE
FUNDING OPPORTUNITY WAS IN 2010,
AND THERE HAVE BEEN 5 PRIOR
ISSUANCES, AND THE NUMBER OF
GRANTS AWARDED IS 32.
THANK YOU.
>> THANK YOU, I SHOULD
INTRODUCED THE BOARD, AND THE
PAST HAS AGREED TO LUMP THESE
TOGETHER AND REHAVE YOU THEM ALL
AT ONCE.
THESE ARE NOT SET ASIDES.
THESE ARE THE PARs, THEY ARE
NOT RFAs AND SO THEY WILL BE
HANDLED BY TODAY SECTIONS AND
DECISIONS WILL BE MADE IN THE
NORMAL WAY.
SO DISCUSSION?
PARs?
>> YEAH, I JUST WANT TO LET YOU
ALL KNOW BECAUSE IT'S SOMETHING
I WONDERED WHEN I WAS A PSA
MEMBER, SO WE REVIEW THESE AND
THIS YEAR, THERE WERE MANY, AND
WE TOOK IT SERIOUSLY, WE
REVIEWED THEM ALL WITH MULTIPLE
REVIEWERS TO INSURE THAT THEY
WERE WERE CONTINUING FORWARD,
THEY'RE NOT ALL HERE, IN SUN
SETTED BUT WE DO VALUE YOUR
INPUT BUT WE WANT TO YOU KNOW TO
WE WERE RIGOROUS IN LOOKING AT
THESE.
>> OTHER DISCUSSIONS OTHER THAN
THANK HEAVENS THE CANCER CENTERS
GOTTEN RENEWED.
>> I HAVE A QUESTION.
YES.
>> SO WHEN WE WERE LOOKING AT
THE CAREER DEVELOPMENT
SUBCOMMITTEE, I GUESS IT WAS
YEARS AGO, NOW, HERE, THERE WERE
SOME DISCUSSION ABOUT THE FACT
THAT CANCER CONTROL POPULATION
SCIENTISTS, THAT THEIR REAL
ACCESS TR CAREER DEVELOPMENT
AWARDS BUT THEY'RE THE K99 TO
R00 NIGHT ROUTINELY AND THERE
HAD BEEN DISCUSSION ABOUT THAT
WASN'T WORKING AS WELL AS WE HAD
HOPED AND THERE WAS A DISCUSSION
ABOUT OPENING BACK UP SOMETHING
THAT WAS AKIN TO THE OLD K07 AND
THEN WE'LL END OR MAYBE OPENING
UP THE K01 SO HAVE YOU 2 POOLS
LIKE AN APPLICANT OF K01S FOR
DIVERSITY AND ANOTHER POOL OF
THAT.
CAN WE KNOW WHAT'S GOING ON WITH
THAT?
N[INDISCERNIBLE]
>> YEAH, THANKS FOR THAT
QUESTION.
SO WE WERE REALLY EXCITED TO
WORK WITH THE CENTER FOR CANCER
TRAINING AND DEVELOP A K01
AWARD.
THIS IS A COLLABORATION BETWEEN
CCT, DCP AND DCCPS, SO THIS NEW
AWARD JUST BECAME AVAILABLE, THE
FIRST RECEIPT DATE WAS IN
FEBRUARY OF THIS YEAR, AND SO
IT'S A NEW K01 AND IT IS
RESTRICTED TO POPULATION
SCIENCES AND PREVENTION AND SO,
YOU NEED TO BE STUDYING IN 1 OF
THOSE AREAS IN ORDER TO RESPOND
TO THE NEW K01, BUT WE ARE
HOPING THAT THIS WILL FILL THE
GAP, THAT WAS NOTED THAT YOU
MENTIONED WHEN THE K07 WENT
AWAY.
KREK, IT'S OPEN TO EVERYONE.
NNOW WE'RE 1 MINUTE OVER.
>> I WAS JUST UNCLEAR WHY WE
HAVE SO FEW AWARDS ON
IMMUNOLOGICAL COHORTS?
I THINK THERE'S ONLY 1 AWARDED
ON THE EPIDEMIOLOGY COHORTS AM I
CORRECT OR IS THERE A
CORRECTION?
>> THAT IS THE NUMBER THAT WAS
LISTED THERE AND I'M GUESSING
THAT IT'S STILL PENDING THE DATA
FOR THIS YEAR NBECAUSE OUR LIST
OF INVESTIGATORS TEND TO USE
THOSE FOR [INDISCERNIBLE].
>> WE NEED TO--ANY OTHER FURTHER
DISCUSSION, WE NEED TO HAVE A
VOTE DO I HAVE A MOTION TO
APPROVE?
SECOND?
OKAY.
THE VOTE IS EITHER TO CONCUR,
NONCONCUR OR DEFER?
SO WE WILL ASSUME THAT PEOPLE
ARE VOTING TO CONCUR.
ARE THERE ANY VOTES--OKAY, I'VE
BEEN TOLD TO ASK, HOW MANY
PEOPLE ARE VOTING TO CONCUR OF
THE BSA IN RAISE YOUR HANDS.
ARE THERE ANY VOTES NOT TO
CONCUR EMPLOY ANY ABSTENTIONS,
OKAY, SO IT'S UNANIMOUS AND WE
HAD A QUORUM QUORUM.
OKAY, I THINK THAT'S DONE WITH
THE BSA BUSINESS FOR THE DAY.
SO, THIS CONCLUDES THE OPEN
SESSION.