WELCOME STAFF AND GUESTS.
BEFORE WE BEGIN TODAY, THERE'S
SOME REQUIRED HOUSEKEEPING AND I
MUST ATTEND TO.
MEMBERS OF THE PUBLIC WHO MAY
WISH TO EXPRESS VIEWS REGARDING
ANY DISCUSS MAY DO BY WRITING
SECRETARY OF THE BOARD AND
WITHIN 10 DAYS FOLLOWING THE
VIRTUAL MEETING.
THEY WILL RECEIVE CAREFUL
CONSIDERATION.
I WANT TO REMIND YOU, YOU MUST
ABSENT YOURSELF DURING
DISCUSSIONS WHEN YOU ARE
PARTICIPATION AND DELIBERATIONS
ON A PROJECT, PROGRAM OR OTHER
SPECIFIC MALTERS WHO CONSTITUTE
A CONFLICT OF INTEREST OR CREATE
THE APPEARANCE OF ONE.
ADVISE THE SECRETARY AND ABSTAIN
FROM PARTICIPATION AND
DISCUSSION OR ACTION REGARDING
THAT MATTER.
IN LIGHT OF THE CURRENT POLICIES
AND CONFLICT OF INTEREST ON
FINANCIAL HOLDINGS AND SPECIAL
GOVERNMENT EMPLOYEES WHICH
INCLUDE ALL MEMBERS OF THIS
BOARD, WE MUST DEPEND ON YOU TO
ABSENT YOURSELF DURING ALL AND
DISCUSSION MATTERS THAT COULD
IMPACT THE STATUS OF THOSE
HOLDINGS.
WE TRUST YOUR JUDGMENT IN THESE
INSTANCES.
TO ENSURE NO INTERRUPTS TODAY,
PLEASE MUTE YOURSELVES AND
REMAIN SO UNTIL RECOGNIZED
MYSELF, PAULETTE, AT THE NCI
DIRECTOR AND THESE SPEAKERS.
BY WE CAN'T PREDICT THE TIME OR
CURRENT OF MOTION YOUR PRESENCE
IN THE VIRTUAL MEETING ROOM FOR
ALL SEGMENTS OF THE MEETINGS IS
A MUST.
OUR NEXT MEETING SPANS
JUNE 14th AND 15th OF THIS
YEAR.
THIS IS GOING TO BE A JOINT
MEETING WITH THE NATIONAL CANCER
ADVISORY BOARD AND IT WILL BE AN
IN-PERSON MEETING.
OUR FIRST ONE IN THREE YEARS.
WITH HYBRID PARTICIPATION
POTENTIAL FOR THOSE WHO ARE
UNABLE TO MAKE IT IN-PERSON.
PLEASE MARK YOUR CALENDARS.
A LIST OF FUTURE MEETING DATES
IS ON THE AGENDA.
AS SUCH, WE NEED TO CONFIRM THE
2025 MEETING DATES WHICH ARE
ALSO LISTED ON THE AGENDA.
I'D LIKE TO CALL FOR A MOTION
SECOND AND DISCUSSION REGARDING
THE PROPOSED MEETING DATES.
I THINK PAULETTE, THAT'S THE
ONLY ITEM SPECIFICALLY AT THIS
POINT?
>> CORRECT.
>> Dr. Flaherty: GREAT.
I'M ASSUMING YOU ALL REVIEWED
THE AGENDA WITH THOSE DATES
BASICALLY I NEED A MOTION AND A
SECOND TO GET US MOVING IN THAT
DIRECTION.
THANK YOU.
>> MOVE TO APPROVE.
>> Dr. Flaherty: THANK YOU.
AND AS WELL.
SO THAT WAS A MOTION AND A
SECOND.
ANY DISCUSSION REGARDING THE
PROPOSED MEETING DATES?
OBVIOUS CONFLICTS THAT MIGHT
INTERFERE WITH MEETING ON THOSE
DATES.
>> JUST QUICK CLARIFICATION,
VERY MUCH APPRECIATED THAT WOULD
BE GREAT AND SO, AM I TO ASSUME
TENTATIVE SCHEDULE AS YOU COME
IN ON THE 14th OR COME IN ON
THE 15th BECAUSE IT'S TWO FULL
DAYS?
>> YOU SHOULD COME IN ON THE
13th BECAUSE THE MEETING WILL
START IN THE 14th.
>> IN THE MORNING?
OKAY.
RIGHT.
ALL RIGHT.
AND WE'LL ABOUT THROUGH THE
15th.
I'M JUST TRYING TO PLAN
SCHEDULES?
>> WE HAVEN'T FOCUSED ON THE
JUNE AGENDA YET.
IN THE PAST WE'VE INCLUDED
AROUND MID-DAY ON THE SECOND
DAY.
>> SOMETIMES 6789 WHICH HOPE
THERE'S A GOOD MANY MORE
CONCEPTS TO DISCUSS AT THE JUNE
MEETING AND SO PAULETTE WILL
KEEP US ADVISED IN TERMS OF THE
NUMBER AND ITS IMPACT ON THE
AGENDA BUT A DAY AND A HALF IS
TYPICAL.
ANY OTHER DISCUSSION?
OKAY.
SO, WITH A MOTION AND A SECOND
TO APPROVE THESE MEETING DATES
AND AS WITH OUR REGULAR VOTING
PROCESS, WHEN WE'RE MEETING
VIRTUALLY, ONLY LOOKING FOR YOUR
PRESENCE ON CAMERAS AND EMPHASIS
AT PRESENCE ON CAMERA IS TAKEN
AS AN AN ACCENT.
PEOPLE CAN ABSTAIN ALTHOUGH I DO
NOT EXPECT ABSTENTIONS FROM THIS
VOTE.
ANY NAY VOTES IN TERMS OF THE
PROPOSED MEETING DATES?
OKAY.
CHECKING ON THE SECOND SCREEN
>> Dr. Flaherty: THE FIRST IS
THE NCI DIRECTOR'S REPORT.
MONICA BERTAGNOLLI.
>> Dr. Bertagnolli: OKAY.
THANK YOU, Dr. FLAHERTY, AND
THANK YOU Dr. GRAY.
IT'S WONDERFUL TO SEE YOU ALL
AND I'M LOOKING FORWARD TO AN
IN-PERSON MEETING IN JUNE.
THAT WILL BE FANTASTIC.
SO TODAY, I'LL GOING TO TALK
ABOUT RESENT PROGRESS.
A LITTLE BIT ABOUT OUR BUDGET
OUTLOOK, ABOUT THE NATIONAL
CANCER PLAN AND THEN ALSO SOME
BRIEF, VERY BRIEF PROGRAM AND
RESEARCH UPDATES.
I'M SURE MANY OF YOU SAW THE
STATE OF THE UNION ADDRESS
PRESIDENT JOE BIDEN CONTINUES TO
SHOW VERY STRONG SUPPORT FOR
WHAT WE ALL SEEK TO DO.
LAST MONTH, HE REITERATED HIS
MESSAGE HE WILL GO BIG IN ORDER
TO ACHIEVE BOLD GOALS FOR
PROGRESS AGAINST CANCER AND HIS
SPEECH WAS TOUCHING.
YOU KNOW, IN HIS UNIQUE WAY, HE
ALWAYS MAKES SURE WE KNOW WHO
WE'RE HERE TO SERVE.
HE CALLED ATTENTION TO EVA, WHO
IS A 3-YEAR-OLD GIRL WITH A RARE
KIDNEY CANCER AND HER PARENTS
WERE UNTIL THE AUDIENCE THERE
AND YOU COULD REALLY SEE ON
THEIR FACES THE STRUGGLE THEY'VE
BEEN THROUGH, THEIR COURAGE AND
THEIR HOPE.
THE GREAT NEWS IS THAT EVA'S
OUTLOOK APPEARS VERY PROMISING.
WE CAN NEVER FORGET IT'S PEOPLE
LIKE HER AND HER PAMLY THAT
WE'RE HERE TO SERVE.
NEXT SLIDE, PLEASE.
>> SO THE SER MOONSHOT,
PRESIDENT BIDEN HAS REITERATED
HIS CALL TO END CANCER AS WE
KNOW IT.
WE HAVE A FIRM GOAL TO CUT THE
MORTALITY RATE BY 50% IN 25
YEARS TO TURN MORE CANCERS FROM
DEATH SENTENCES INTO TREATABLE
DISEASES AND PROVIDE MORE
SUPPORT FOR PATIENTS AND
FAMILIES.
ACHIEVING THIS WILL CERTAINLY BE
TRANSFORM THE EXPERIENCE WITH
CANCER AND SOMETHING WE THINK
NOT ONLY IMPORTANT AND IT'S VERY
ACHIEVABLE.
WE'LL EXCELLENT DONE BY NCI
DIVISION OF CANCER AND GENETICS
ANAND IT AND THERE ANNA COMPANY
COMMENTARY AS WELL SOME EFFORTS
UPCOMING AT AACR IN APRIL.
SO, KEEP ON THE LOOK OUT FOR
THIS.
NEXT SLIDE.
THE 2024 BUDGET BREAKDOWN.
WELL, PRESIDENT JOE BIDEN SHOWED
HOW MUCH OF A PRIORITY CANCER
PROGRESS IS TO HIM.
IN HIS FISCAL YEAR 2024 BUDGET
REQUEST JUST RELEASED LAST WEEK.
HE PROPOSED A TOTAL BUDGET OF
7.8 BILLION FOR NCI FOR FISCAL
YEAR 2024.
WHICH WOULD BE A 6.9% INCREASE.
THAT WOULD BE A GREAT BOOST.
AS YOU KNOW, WE'RE IN THE LAST
YEAR OF 21st CENTURY CURES
AGENT FUNDING PROVIDED THE
MOONSHOT PENDING HELPED US TO
LAUNCH AN INCREDIBLE ARRAY OF
TRANSFORMATIVE RESEARCH
PROJECTS.
THE PRESIDENT'S BUDGET WOULD
HELP US AVOID A FUNDING CLIFF
WITH 216 MILLION YOU SEE THERE
IN THE MIDDLE, WHICH MATCHES
THIS YEAR'S AMOUNT.
HE ALSO CALLED FOR A
$500 MILLION INCREASE FOR NEXT
YEAR GIVING US $716 MILLION
TOTAL INCREASE FOR NCI FOR 2024.
ONE SOMEWHAT UNUSUAL AND
EXCITING ASPECT OF THE BUDGET IS
IT ALSO PROPOSES REAUTHORIZATION
OF THE 21st CENTURY CURES ACT
AND MANDATORY FUNDING OF
$1.45 BILLION BUDGET AUTHORITY
FOR NCI IN FISCAL YEAR 2025 AND
2026.
SO, WE ARE VERY EXCITED TO
SUPPORT THOSE AUTHORIZING
EFFORTS HAD THE FUTURE.
YOU SEE HERE THAT IN RESENT
YEARS, CONGRESS APPROPRIATION
HAS COME IN HIGHER THAN THE
PRESIDENT'S NUMBERS SIGNALING
THEIR STEADY COMMITMENT TO
CANCER PROGRESS.
WITH THIS BUDGET REQUEST,
HOWEVER, PRESIDENT JOE BIDEN HAS
TRULY COMMUNICATED TO CONGRESS
THAT HE WANTS TO GO BIG.
IT WILL BE UP TO CONGRESS TO
DECIDE HOW MUCH FUNDING IS
ACTUALLY APPROPRIATED TO HAVE
NCI AND ACROSS ALL FEDERAL
AGENCIES.
M.K. HOLOHAN WILL SPEAK ABOUT
WHAT IT MEANS IN HER SECTION TO
FOLLOW.
WE GOT GOOD NEWS FROM CONGRESS
IN DECEMBER.
PRESIDENT JOE BIDEN SIGNED
LEGISLATION THAT PROVIDED BIDE
THROUGH SEPTEMBER 30th OF THIS
YEAR TO OUR BASE BUDGET
AS WELL AS A $22 MILLION
INCREASE TO THE FINAL YEAR OF
INITIAL MOONSHOT FUNDING.
THAT MEANS, WHEN YOU ADD IT ALL
UP, WE RECEIVED $216 MILLION IN
MOONSHOT FUNDING FOR 2023 AS
ANTICIPATED FROM THE 21s
21st CENTURY CURES ACT.
THE ADDITIONAL INCREASE TO OUR
BASE MADE IT POSSIBLE TO FUND
MORE COMPELLING BELONG WORKER
EFFORTS OUTSIDE OF THE POOL LIKE
OUR CLINICAL TRIALS NETWORKS,
CORE SUPPORT FOR NCI DESIGNATED
CANCER CENTERS AND THIS
CONTINUES OUR UPWARD TREND FROM
THE EIGHTH PERCENTILE IN 2019
AND IT'S STILL NOT AS HIGH AS WE
WOULD LIKE AND WE'RE STILL LEAVG
INNOVATIVE IDEAS ON THE TABLE.
IT SHOWS THAT WE'VE MADE STEADY
PROGRESS IN OUR ABILITY TO FUND
IMPORTANT RESEARCH.
WE WERE ALSO ABLE TO INCREASE
THE EARLY STAGE INVESTIGATOR
RO1s TO THE 17th PERCENT UP
FROM 16 PERCENT.
BECAUSE OF THESE PAYLINE
INCREASES, WE ARE ABLE TO FUND
MORE THAN 100 ADDITIONAL RO1s
AND THE ESI AWARDS COMPARED TO
LAST YEAR.
RPG FUNDING IS CRITICAL.
IT ALLOWS INVESTIGATORS ACROSS
THE NATION TO SUBMIT THEIR VERY
BEST IDEAS AND TURN THEM INTO
ANSWERS THAT DRIVE PROGRESS.
IF IN ADDITION, FUNDING CRITICAL
INFRASTRUCTURE INCLUDING
INFORMATION TECHNOLOGY IS OF A
BIG PRIORITY FOR NCI.
THESE ARE THE THINGS THAT
AMPLIFY RESEARCH RESULTS, DRIVE
NEW COLLABORATION AND ENSURE
MAXIMAL USE OF OUR PRIOR
INVESTMENTS IN RESEARCH.
SO WE'VE ALSO ALLOCATED NEW
FUNDING TO MEET THESE GOALS.
UNFORTUNATELY, WE, LIKE ALL OF
YOU, HAVE NOT BEEN MANY UN IMMUO
SIGNIFICANT INFLATION.
AS A RESULT, THESE DECISIONS TO
SUPPORT THE RPG POOL AND SUPPORT
OUR INFRASTRUCTURE ALSO MEANS
WE'VE NEEDED COST-CUTTING
ELSEWHERE.
WE DECIDE TODAY PAY MOST
CONTINUING RAIN CON POM EATING
GRANTS THAT IS YEARS TWO THROUGH
FIVE OF THE FIVE-YEAR GRANT AT
98% AND -- JUST AS WE ASKED OUR
INTRAMURAL RESEARCHERS TO DO.
AND THIS SLIDE JUST ILLUSTRATES
THE CHALLENGE THAT -- AND YOU
MIGHT HAVE SEEN THIS IN OUR
FISCAL YEAR 2024, PROFESSIONAL
JUDGMENT BUDGET ON THE WEBSITE
SHOWS THE CHALLENGE WE TAKE ON
EVERY TIME WE RAISE THE PAYLINE
BY 1%.
WHEN WE INCREASE THIS, WE MAKE A
COMMITMENT TO SUSTAIN THOSE NEW
GRANTS FOR FIVE YEARS IN THE
FUTURE.
WE ALWAYS REQUIRE ADDITIONAL
RESOURCES IN THE OUT YEARS WHICH
ARE YEARS TWO THROUGH FIVE JUST
TO SUSTAIN FUNDING AT THAT
PERCENT STYLE LEVEL.
AND EVEN MORE, IF WE ARE TO GO
ON TO FURTHER INCREASE THE
PAYLINE.
LET ME EMPHASIS OUR PAYLINE AT
12% THIS YEAR IS THE HIGHEST IT
HAS BEEN SINCE 2010.
I'M SURE YOU WILL AUTOMATIC SEE
ALL SEE THEIMPORTANCE MUCH THIST
INTRODUCES FUNDING CHALLENGES
FOR FUTURE AND HAS ALSO ASKED US
TO DO SOME BELT-TIGHTENING
ELSEWHERE.
I WROTE ABOUT THESE BUDGET
DECISIONS IN A RESENT POST ON
THE NCI BOTTOM LINE BLOG.
AS FOR THE NCI CANCER CURRENT
BLOGS, I ALSO WROTE A POST THAT
EMPHASIZES THAT THIS REALLY IS A
GREAT OPPORTUNITY FOR CANCER
RESEARCH.
HIGHLIGHTING PROGRESS FROM
DECADES OF INVESTMENTS,
PRESIDENT JOE BIDEN'S
COMMITMENT, AND IMPORTANT NEW
NCI PROGRAMS.
I ALSO UNDERSCORED IN THIS BLOG
THE IMPORTANCE OF THE LAST MILE.
FROM VALIDATION OF A SUCCESSFUL
INTERVENTION AGAINST CANCER TO
ITS WIDESPREAD ADOPTION AND
BROAD IMPLEMENTATION.
THIS LAST MILE REQUIRES
PARTICIPATION FROM SO MANY
OTHERS THROUGHOUT OUR SOCIETY.
I WANT TO EMPHASIZE IF WE ARE
GOING TO END CANCER AS WE KNOW
IT AND NOT SURE ALL OF OUR
ADVANCES BENEFIT EVERYONE WHO
NEEDS THEM, IT TAKES ALL OF
SOCIETY APPROACH TO BRIDGE THE
GAP.
NCI CANNOT DO THIS ALONE.
IN THIS POST, I ALSO TOUCHED
BRIEFLY ON OUR NEW NATIONAL
CANCER PLAN, WHICH IS AIMED AT
EXACTLY THIS LAST-MILE ISSUE.
OVER THE LAST FEW MONTHS, WE
WORKED WITH RESEARCHERS
REPEATING BOTH WITHIN AND
OUTSIDE OF THE NCI TO PRODUCE A
NEW NATIONAL CANCER PLAN TO
ALIGN BROAD SOCIETAL ENGAGEMENT
AND FOCUS ON CRITICAL NEEDS TO
END CAP SER AS WE KNOW IT.
AND THAT MEANS EVERYBODY WITH
CANCER AND EVERY CANCER.
IT EMBRACES THE IDEA THAT
EVERYONE HAS A ROLE TO PLAY
ACROSS FEDERAL AGENCIES AND AS
WELL AS INDUSTRY AND ANG A
DAMIA, ADVOCACY GROUPS, NON
PROFITS EVEN CAREGIVERS AND
INDIVIDUAL PATIENTS.
OUR INTENT IS WHEN ANY
ORGANIZATION OR PERSON LOOKS AT
THIS PLAN, THEY WILL SEE WHERE
THEY FIT AS A CONTRIBUTE OOR TO
PROGRESS.
IT PROVIDES A FRAMEWORK THAT
WILL HELP EVERYONE SEE THE FULL
RANGE OF WHAT IS NECESSARY TO BE
ABLE TO STRATEGIZE AND MOST
IMPORTANT OF ALL TO WORK
TOGETHER TO SUSTAIN AND
ACCELERATE PROGRESS.
WE'RE IN THE FINAL PHASES NOW
AND WE ARE GETTING INPUT FROM
SUCH A WIDE RANGE OF
STAKEHOLDERS ON THIS PLAN.
IT WILL VERY SOON BE FINALIZED
AND COMMUNICATED WIDELY TO BE TO
THE PUBLIC.
JUST TO BE CLEAR, THE NATIONAL
CANCER PLAN IS NOT THE SAME AS
THE REIGNITED CANCER MOONSHOT.
THE CANCER PLAN IS ALIGNED WITH
ALL OF THE MOONSHOT GOALS.
IT PROVIDES A VISION FOR
EVERYONE ACROSS ALL SOCIETY TEE
TO WORK TOWARDS THOSE GOALS AND
REALLY FOCUSES ON HOW WE WILL
UTILIZE OUR COLLECTIVE RESOURCES
SO THAT WE ACHIEVE THE FASTEST
POSSIBLE RESULTS TO END CANCER
AS WE KNOW IT FOR ALL PEOPLE.
THE MOONSHOT IS HOW THE
PRESIDENT IS CALLING ON ALL OF
US TO MOBILE SIZE SOCIETY TO
TAKE ACTION, BRING GOVERNMENT
AGENCIES TOGETHER TO FOCUS AND
WORK TOGETHER AND HE IS ALSO
ADVOCATING FOR THE RESOURCES
NEEDED TO ACCELERATE OUR
PROGRESS.
SO IN THIS WAY, THE NATIONAL
CANCER PLAN AND THE MOONSHOT
WORK VERY MUCH HAND IN HAND.
AND WE ARE COORDINATING WITH THE
WHITE HOUSE TO ENSURE THE
NATIONAL CANCER PLAN PROVIDES A
FOCUS FOR ACHIEVING THE GOALS OF
THE CANCER MOONSHOT.
ANOTHER VERY IMPORTANT THING TO
DRY YOUR ATTENTION TO IS ARPA-H.
THE NEW ADVANCED RESEARCH
PROJECTS AGENCY FOR HEALTH.
A VERY IMPORTANT -- NEW PARTNER
FOR CANCER RESEARCH.
RENEE WEGRZYN AND I TALK
FREQUENTLY AND WORKING TOGETHER
TO DECIDE HOW ARPA-H AND NCI CAN
HAVE THE MOST POWERFUL
COLLABORATION.
I CAN TELL YOU THAT ACROSS ALL
OF NIH, WE'RE GIVING HER MANY
GOOD IDEAS FOR HOW THIS NEW
AGENCY CAN HELP ALL OF US.
WE KNOW THAT THERE WILL BE SOME
NOTABLE DIFFERENCES IN HOW FAR
NCI AND ARPA-H WILL OPERATE.
THESE WILL HELP US TO BE
COMPLIMENTARY.
WHAT NCI DOES, OFTEN REQUIRED
MANY DECADES.
WE TAKE THE LONG VIEW AND
SUSTAIN OUR PROGRAMS OVER TIME.
WE ARE RESPONSIBLE AT NCI FOR
EVERYTHING FROM FUNDAMENTAL
SCIENCE ALL THE WAY TO CARE
DELIVERY RESEARCH TO ENSURE THAT
A LABORATORY DISCOVERY
TRANSLATES INTO A OF CLINICALLY
TESTED PROCEDURES DRUG OR DEVICE
THAT BENEFITS PEOPLE.
ARPA-H IS FOCUS IS VERY
DIFFERENT.
THINK OF IT AS A SWAT TEAM OR
RAPID DEPLOYMENT THAT IDENTIFIES
KEY ISSUES WITH HIGH-RISK, HIGH
REWARD, RESEARCH FOCUS.
THEY THEN NOT ENGAGE THE MOST
IMPORTANT PLAYERS FROM ACROSS
THE RESEARCH AND DEVELOPMENT
ECOSYSTEM TO SOLVE A PROBLEM IN
A RELATIVELY SHORT TIMEFRAME.
WE'RE VERY EXCITE TODAY WORK IN
WAYS THAT COMPLIMENT WHAT ARPA-H
BRINGS.
WE VIEW OURSELVES AS THE RECEIVE
OF THESE SOLUTIONS TO PROBLEMS
THAT ARPA-H PRODUCES.
AND THOSE PROVIDING SCIENTIFIC
LEADERSHIP TO THEIR PROJECTS O
THEY BEST ADDRESS THE NEEDS OF
CANCER RESEARCH.
NEXT SLIDE.
I'M ALSO PLEASED TO SAY THAT THE
CANCER GRAND CHALLENGES
COLLABORATION HAS ENTERED INTO A
NEW PHASE THROUGH OUR
PARTNERSHIP WITH CANCER RESEARCH
U.K., WE JUST ANNOUNCED NINE NEW
RESEARCH CHALLENGES AIMED AT
TACKLING PROFOUND PROBLEMS IN
RESEARCH, YOU SEE THEM LISTED.
TO SUPPORT THE BRIGHTEST MINDS
ACROSS THE GLOBAL RESEARCH
COMMUNITY AS THEY TACKLE SOME OF
THE MOST COMPLEX CHALLENGES IN
CANCER RESEARCH.
NCI CLINICAL TRIALS ARE
ABSOLUTELY ESSENTIAL.
THEY TURN POSSIBILITIES INTO
TREATMENT PREVENTION AND EARLY
DETECTION OR DIAGNOSIS METHODS.
FOR A VARIETY OF REASONS, WE
JUST DON'T HAVE ENOUGH PEOPLE
PARTICIPATING IN OUR TRIALS AND
ESPECIALLY THOSE FROM MINORITY
GROUPS OR FROM RURAL AREAS AND
WE ALSO DON'T GET RESULTS FAST
ENOUGH.
WE NEED NEW STRUCTURES THAT ARE
MORE NIMBLE AND MORE INCLUSIVE
OF ALL OF THE PEOPLE WE'RE HERE
TO SERVE.
SO AT NCI WE'VE LAUNCHED WHAT
WE'RE CALLING OUR CLINICAL
TRIALS INNOVATION UNIT TO
SPEARHEAD PROGRESS.
THIS IS A VERY EXCITING
COLLABORATION BETWEEN NCI, THE
FDA, AND THE EXTRAMURAL CANCER
CLINICAL RESEARCH COMMUNITY.
THE UNIT WILL SELECT A FEW VERY
HIVE PRIORITIES SCIENTIFIC
QUESTIONS THAT ARE PARTICULARLY
STUDY DESIGN AND OPERATIONAL
PROCEDURES.
THIS IS FOR THIS INNOVATION
UNIT, ALL ASPECTS ARE ON THE
STABLE.
STUDY ELIGIBILITY, COMPARE ARMS,
ENDPOINTS, DIAGNOSTICS, USE OF
TELEHEALTH AND OTHER STUDY DATA
COLLECTION AND PROCEDURES AND
PARTICIPANT ENGAGEMENT
STRATEGIES AND EVERYTHING THAT
CAN HELP US ENGAGE MORE BROADLY
AND DELIVERING RESULTS FASTER IS
OPT TABLE.
WE ANTICIPATE SUCCESS WILL
APPROACH US AND -- WE HAVE A FEW
IMPORTANT UPDATES.
EARLY DETECTION OF CANCERS CAN
SIGNIFICANTLY IMPROVE OUTCOMES
BUT THAT UNFORTUNATELY, NOT
ENOUGH PEOPLE ARE GETTING THE
RECOMMENDEDDED SCREENING.
A NEW NCI FUNDED STUDY FOUND
THAT AMONG A SAMPLE OF PRIVATE
SECTOR WORKERS, MEMBER OGRAPHY
AND COLORECTAL SCREENING, WERE
HIGHER IN AREAS WHERE THIS
SUGGESTS A LACK OF PAID SICK
LEAVE COVERAGE PREVENTS A
BARRIER TO CANCER SCREENING AND
INFORM POTENTIAL POLICY SOLUTION
THAT'S COULD BOOST SCREENING AND
SAVE LIVES.
WE KNOW THAT ALCOHOL CAN
INCREASE RISK OF DEVELOPING
SEVERAL CANCER TYPES.
AND AN NCI STUDY FOUND THAT MOST
AMERICANS WEREN'T AWARE OF THIS
CONNECTION.
THE RESEARCHERS CONCLUDED THAT
CHANGES NEED TO BE MADE TO RAISE
PUBLIC AWARENESS OF THIS
IMPORTANT FACT.
WE KNOW THAT AWARENESS DOESN'T
GUARANTEE ACTION.
WE'LL NEED FURTHER RESEARCH TO
SOLVE THESE CHALLENGES.
WE MAY BE ON THE PATH TO NEW
ANSWERS TO A CHILDHOOD CANCER
THAT IS DIFFICULT TO TREAT.
EVEN OCCURS IN SOME
DIFFICULTIES.
RESEARCH SPONSORED BY OUR CANCER
MOONSHOT'S FUSION ONCOPROTEINS
IN FOUND THAT THE EVT6 PROTEIN
MODULATES THE INFUSION ON CO
PROTEIN RESPONSIBLE FOR THE
MAJORITY OF EWING CAR COMA.
IT'S HOPED IT WILL PREVENT A
TARGETED DRUG THAT INTER FIERCE
WITH THE ACTION BETWEEN EVT6 AND
THE FUSION ON CO PROTEIN AND
LEAD TO TREATMENT.
WE ANTICIPATE SEEING MORE MORE
RESULTS OUT OF THIS VERY
IMPORTANT MOONSHOT CONSORTIUM.
THE CHILDHOOD CANCER DATA
INITIATIVE IS REALLY PROCESSING
IN LINE WITH ALL OF OUR HOPES
FOR THIS IMPORTANT PROGRAM.
GETTING DATA WE NEED TO IMPROVE
OUR UNDERSTANDING OF CANCER,
ESPECIALLY CHILDHOOD CANCER,
WHERE DATA HAS BEEN DIFFICULT TO
COME BY IS VERY CHALLENGE AND
COSTLY AND THE GOOD NEWS IS HEAD
LAY AND TO GET MUCH CHILD AND
INTO THE HANDS OF SCIENTISTS
THROUGH CCDI.
THIS FOCUS PROGRAM HAS MADE
TREMENDOUS PROGRESS TO
ACCUMULATE DATA THAT HAS BEEN
HISTORICALLY VERY DIFFICULT FOR
RESEARCHERS TO ACCESS AND FOR
RESEARCH TEAMS TO SHARE.
THE AGREEMENT IS TAKEN CHARGE OF
CCDI BRINGING HIS VAST
EXPERIENCE FROM TIME LEADING AND
ALSO WORKING AT FDI AND
MARCH 21st, CCDI WILL HOST THE
SYMPOSIUM TO GATHER EXPERTS FROM
ACROSS COUNTRY AND WE'RE VERY
EXCITED TO HIGHLIGHT NEW
RESOURCES THAT ARE AVAILABLE TO
THE SCIENTIST I CAN COMMUNITY.
AS WELL AS HIGHLIGHT FUTURE AND
OPPORTUNITIES.
AND TO INTEND YOU CAN DO IT
IN-PERSON EVEN IF YOU ARE NOT
AND RESEARCHER BUT IF YOU ARE
PARTICULARLY INTERESTED IN
CHILDHOOD CANCER AND TO ALL OF
OUR WORK.
IT'S A PLAN FOR THE FUTURE.
I THINK MORE THAN ANYTHING THAT
WE'VE DONE, CCDI IS
DEMONSTRATING THE GREAT POWER OF
DATA SHARING AND COLLABORATION
AND WE REALLY THINK THIS CAN BE
A PARADIGM FOR WHAT WE CAN DO
FOR EVERYONE WITH CANCER AND
EVERY RESEARCH TEAM.
SOME FINAL THOUGHTS, THERE'S A
LOT HAPPENING.
FROM STEP-BY-STEP SCIENCE THAT
WE SIMPLY WON'T MAKE PROGRESS
WITHOUT, WHICH WE'RE VERY HAPPY
TO SAY WE'LL INCREASE WITH MORE
RO1 FUNDING, TO HIGH-LEVEL
PLANNING TO LEAD OF BEST ALIGN
THE CANCER RESEARCH ENTERPRISE
AND TRULY ALL OF OUR SOCIETY AS
WE ACHIEVE THE PROGRESS EVERYONE
IS COUNTING ON.
WE'RE STILL VERY FAR FROM WHERE
WE NEED TO BE FOR THE PEOPLE WHO
ARE COUNTING ON US.
BUT I'M REALLY EXCITED ABOUT THE
STEPS WE'RE TAKING NOW AND
RECENT ACCOMPLISHMENTS TO ENSURE
WE CAN WORK TOGETHER AND WE'RE
ON THE RIGHT PATH TO DO SO.
SO LET ME END HERE, AND GET TO
THE BEST PART WHICH IS TO TAKE
ALL OF YOUR QUESTIONS.
IF YOU.
>> HI.
THANK YOU, THAT'S ABSOLUTELY
WONDERFUL.
SO EXCITE TO GO SEE.
I'M CURIOUS ABOUT THE
INNOVATIONS FOR CLINICAL TRIALS.
YOU MENTIONED THE BROAD SCOPE.
I KNOW YOU KNOW WHAT I'M GOING
TO ASK.
DOES INNOVATIONS INCLUDE BETTER
WAYS TO WRITE TRIALS AND AUTHOR
TRIALS AND WHAT ARE YOUR
THOUGHTS ABOUT WAYS WE CAN
ENCOURAGE THE SPONSORS TO USE
STRUCTURED FORMS OF AUTHORIZING
TRIALS THAT MAKE IT EASIER TO DO
DOWNSTREAM INA LIT TICKS AND.
>> EVERY PASS OF TRIAL DESIGN IS
ON THE STABLE AND AND INCLUDING
WHAT YOU JUST DESCRIBED AND WHAT
IS GIVING US, GOT US REALLY
EXCITED AND YOU MENTIONED
INDUSTRY AND I MEAN, ANY
COLLABORATORS AND WE'RE EXCITED
ABOUT FDA IS AT THE TABLE
THEY'RE WEIGHING IN AND I CAN
TELL YOU THAT THE FIRST TRIAL TO
COME OUT OF THE FIRST-GENERATION
OF THE TRIALS AND IT'S A
REGISTRATION TRIAL DESIGNED TO
BE REALLY, REALLY NIMBLE AND
SIMPLE AND STRAIGHT FORWARD AND
ABLE TO EVERY COMMUNITY AND
UNITED STATES THROUGH THE NCTN
AND THE ENCORE SO HAVING FDA
THERE HAS BEEN A POWERFUL FORCED
TO MAKE SURE THAT WE CAN DO
THIS.
KAREN.
>>
>> THANK YOU FOR THAT
PRESENTATION MONICA IT'S GREAT
AND EXCITE TO GO SEE THE
PROGRESS.
ANY QUESTIONS ABOUT ARPA-H AND
BEING DONE WITHIN NCI AND THE
RIGHT KIND OF PROTECT OR ARPA-H.
>> ARPA-H HAD ITS FIRST YEAR,
FIRST YEAR CELEBRATION AND AT
THAT TIME, YOU CAN GO TO THEIR
WEBSITE THERE'S NOW A BROAD
AGENCY ANNOUNCEMENT AND OUT TO
BE SO ANYONE CAN SUBMIT
PROPOSALS AND ARPA-H AND THEY'RE
AND THEIR PROJECT MAPPINGERS AND
ANY IDEAS CAN GO THERE.
WE'RE TELLING PEOPLE HOW TO
COLLABORATE WITH NCI AND WE HAVE
Dr. DINA SINGER WHO MANY OF
YOU I'M SURE KNOW AND IS NCI
COORDINATOR FOR INTERACTIONS
BETWEEN NCI AND ARPA-H.
Dr. SINGER IS HAPPY TO TAKE --
DROP HER AN E-MAIL IF YOU SAY I
HAVE AN IDEA THAT MIGHT
FELLOWSHIP IN ARPA-H AND INVOLVE
WORK THAT AND DO WITH NCI AND
Dr. SINGER IS REALLY HELPING
US AND MANAGE ALL OF THOSE THAT
INTEREST.
AND SHE'S VERY BUSY DOING THAT.
SO IT'S EXCITING.
WE REALLY -- WHAT WE WANT TO DO
IS WHATEVER ARPA-H DEVELOPS, WE
WANT TO BE THE USERS, RIGHT.
WE WANT TO BE THE END USERS.
THE OTHER THING I HEARD WHICH IS
VERY POSITIVE IS WE'RE GOING TO
BE THE TEST ENVIRONMENT.
YOU KNOW, IF THEY DEVELOP
SOMETHING NEW AND SEE WHETHER IT
WORKS OR NOT, WE'LL BE WITH HER
TO HELP ASSIST.
TAKE A LOOK, IT'S THERE AND
READY TO GO.
>> GREAT, THANK YOU.
>> Dr. Flaherty: KAREN.
>> MONICA, I REALLY APPRECIATE
THE FISCAL TRANSPARENCY AND THE
PAYLINE AND WHAT THE OPPORTUNITY
COSTS WAS THERE AND YOU KNOW,
KUDOS FOR GETTING THE RPG
PAYLINE TO WHAT IT IS RIGHT NOW
AND LOOK FORWARD TO FURTHER
DISCUSSIONS SO THANK YOU FOR
THAT AND MY QUESTION HAS TO DO
WITH THE REISSUANCE OF THE
NATIONAL CANCER ACT AND SO I'M
WONDERING IF THERE'S ANYTHING
YOU CAN TELL US ABOUT PROPOSED
CHANGES, ADDITIONS, ANYTHING
THAT WE MIGHT EXPECT AS WE THINK
TOWARDS WHAT THAT LOOKS LIKE FOR
THE PATH FORWARD?
>> Dr. Bertagnolli: YEAH, SO
WE'RE STILL WORKING WITH THE
OSTP WITH THE PRESIDENT ON WHAT
A REISSUANCE WILL LOOK LIKE, YOU
KNOW, I REALLY CAN'T SHARE A LOT
YET OTHER THAN IT'S VERY CLEAR
THAT THE PRESIDENT WANTS NCI TO
HAVE ALL THE TOOLS THAT IT NEEDS
TO MAKE THE FASTEST POSSIBLE
PROGRESS.
AND SO, NOW WE'RE WORKING ON
EXACTLY WHAT THOSE TOOLS AND
AUTHORITIES LOOK LIKE.
AND IT'S A TOPIC THAT GOES WAY
MOPPED HERE AND HOW WE DO OUR
HIGHERING AND IT'S REALLY THE
NUTS AND BOLTS AND NITTY GRITTY
OF HOW WE GET WORK ACCOMPLISHED
BUT I CAN JUST TELL YOU THAT THE
PRESIDENT'S OFFICE IS BEHIND NOT
PUTTING WHAT WE NEED IN THERE TO
BE EFFICIENT, AND MORE NIMBLE
THAN WE'VE BEEN AND MAKE GREAT
PROGRESS SO WE'RE EXCITED ABOUT
IT.
>> ONE OF THE THINGS THAT'S
REFRESHING THAT WE HEARD IN YOUR
PRESENTATION THE INCLUSION OF
THE FDA SO YOU GET WHERE I'M
HEADED.
I HOPE IT IS INCLUDED IN THIS
REISSUANCE.
>> Dr. Bertagnolli: I CAN TELL
YOU ABSOLUTELY WHAT HAS ALREADY
BEEN INCLUDED IS THE FACT THAT
THE NATIONAL CANCER PLAN IS BEEN
PRESENTED TO, WELL IT WILL BE
TOMORROW, I BELIEVE, PRESENTED
TO THE SECRETARY OF HEALTH AND
HUMAN APP SERVICES AND IT'S
ALREADY GONE THROUGH ALL OF
HIS -- THIS IS WHY WE WONDER
I'VE BEEN TALKING ABOUT THIS
PLAN FOR A WHILE.
WHY IS IT TAKING TIME TO
DELIVER?
THAT'S BECAUSE WE HAVE
ENGAGEMENT AND INVESTMENT ACROSS
HEALTH AND HUMAN SERVICES ACROSS
NCI AND ACROSS OSTP AND YOU
KNOW, SO THAT ALL OF GOVERNMENT
APPROACH IS VERY MUCH GOING TO
BE REFLECTED IN THE PLAN.
WHICH IS KEY.
WE KNOW WHAT WE NEED TO MANAGE
TO AND WE'VE ALL AGREED -- YOU
KNOW, WE'VE ALL SIGNED ONTO IT
SO RIGHT THERE THAT'S A
TREMENDOUS STEP.
>> THANK YOU, THAT WAS GREAT.
I WAS HEART END TO HEART ABOUT
THE INCREASE IN CANCER FUNDING.
THE COST OF DOING SCIENCE IS
REALLY GOING UP AND ESPECIALLY
BECAUSE MANY OF US ARE FACING
THE ISSUE OF OUR TRAININGS
NEEDING TO BE SUPPORTED WITH THE
LIVING RAGE AND KA OFFERING CAL
SALARY TO INDUSTRY AND WE
ARE NOT BUDGETED TO REALLY MEET
THOSE SALARY INCREASES AND
SALARY RANGE IN GRANTS ARE OUT
DATE AND SOME OF US ARE USING
GRANTS FUNDED YEARS AGO WHERE
THE GRANTS YOU KNOW, WHERE THE
SALARY RANGING ARE NOT
UP-TO-DATE SO WHAT IS NCI THINK
ABOUT HOW WE CAN ADDRESS THIS
AND IS THERE ANY DISCUSSION THAT
NCI IS HAVING WITH CANCER
CENTERS AND INSTITUTIONS ABOUT
HOW WE CAN SORT OF MEET THESE
DIFFERENT PRIORITIES.
>> OH, BOY.
WE ARE JUST SO CONCERNED AS YOU
ARE ABOUT THE ISSUE OF SALARY
AND YOU KNOW, AND FOR OUR
TRAINEES AND ABSOLUTELY AND DO
WE WANT BIGGER GRANTS OR FEWER
GRANTS?
IF YOU GOT BIGGER GRANTS, YOU
WILL HAVE FEWER.
IF YOU HAVE THE SAME GRANTS, YOU
CAN HAVE MORE.
IT'S THE MATH.
SO, WE ARE ABSOLUTELY OPEN TO --
IF WE RAISE, WE CAN RAISE THE
AMOUNT OF -- WE CAN RAISE
SALARIES BUT THAT WOULD BE FEWER
GRANTS OVER ALL.
THE PAYLINE WILL GO DOWN.
THAT'S WHAT WE'RE GOING TO BE
FIGHTING.
THAT'S PART OF AN ONGOING
DISCUSSION WE'RE HAVING WITH THE
CANCER CENTER DIRECTORS AND
WE'LL HAVE A RETREAT IN MAY
COMING UP AND THAT'S THE MATH.
THAT'S THE ONLY TIME YOU NEED --
>> I KNOW.
I GUESS ONE OF THE ISSUES IS
MAYBE TO CREATE A SITUATION
WHERE IN OF THE INDIVIDUAL
INVESTIGATORS ARE SORT OF
REQUIRED TO MEET THESE MANDATES
BASED ON THE NOT INSTITUTIONAL
CAN THEY MAKE SURE THERE'S A
GRACE PERIOD TO MAKE SURE THESE
ARE PHASED IN AS OPPOSED TO KIND
OF PUT INTO PLACE WHICH MAKES IT
CHALLENGES FOR INVESTIGATORS
WORKING UNDER NCI GRANTS THAT
ARE FUNDED YEARS AGO.
>> I DON'T KNOW OF ANY CHANGES
WE'RE MANDATING AT THIS POINT.
IT SOUNDS LIKE IT'S
DEFINITELY -- THIS IS AN ONGOING
CONVERSATION.
YOU WILL SEE IN THE NATIONAL
CANCER PLAN AND UP WITH GOAL OF
THE PLAN IS WORKFORCE.
AND ALL ABOUT THIS ISSUE AND HOW
WE REALLY ALL NEED TO WORK
TOGETHER ON THIS ON SO MANY
LEVELS.
THAT'S A LONG DISCUSSION AND WE
STILL HAVE SIGNIFICANT AMOUNT OF
WORK TO DO WITH THE COMMUNITY TO
FIGURE OUT WHAT THE RIGHT THING
TO DO IT IS WE'RE VERY OSHA TO
ANY KIND OF SOLUTION THAT BRINGS
BENEFIT TO OUR TRAINEES.
>> Dr. Flaherty: WE'RE GOING TO
BE CHALLENGED FOR TIME.
I'M GOING TO HONOR THE FIRST
TIME SO GO AHEAD.
>> THANK YOU.
THIS IS GOING TO BE QUICK.
MONICA, THANK YOU SO MUCH FOR
THIS.
I WAS REALLY INTERESTED ABOUT A
CLCLINICAL TRIALS AND ALL OF
GOVERNMENT MEANS ALL OF
GOVERNMENT WORKS AGAIN.
THE QUESTION IF YOU ARE WILLING
TO SHARE IS TO WHAT EXTENT IS
THIS GOING TO BE POINTED IN THE
DIRECTION OF ADDRESSING REALLY
THE SYSTEMIC BARRIERS TO
PARTICIPATION BY PLAQUE PEOPLE,
HISPANIC PEOPLE, NATIVE AMERICAN
PEOPLE BECAUSE IT SEEMS TO BE
REALLY IMPORTANT TEST BED OR
LABORATORY FOR THIS SORT OF
EXPERIMENT AND SIMPLIFY AND MAKE
THEM MORE ACCESSIBLE SO MANY
MORE PEOPLE NEED IT DESPERATELY
CAN GET ACCESS TO LIFE SAVING
THERAPIES.
>> Dr. Bertagnolli: OH, YES.
IT'S NOT JUST SIMPLIFIED.
IT'S MEETING EVERY DIVERSE
COMMUNITY WHERE THEY ARE, RIGHT.
IT'S A COMPLETELY DIFFERENT
SOLUTION FOR SOMEONE WHO LIVES
WHERE I GREW UP, WHICH IS
100 MILES FROM ANY HOSPITAL IN A
VERY RURAL LOCATION TO SOMEONE
WHO LIVES ON A INDIAN
RESERVATION OR A CITY WHERE THEY
DON'T HAVE GOOD ACCESS TO
HEALTHY FOOD.
EVERY COMMUNITY NEEDS A
DIFFERENT SOLUTION AND WE'VE
LEARNED THAT THEY'RE NOTING COME
TO US, WE NEED TO GO TO THEM.
THAT'S INTER WOVEN THROUGH THE
NATIONAL CANCER PLAN.
YOU WILL SEE THIS THEME AND IT'S
SO DIVERSE AND WE HAVE TO GO TO
THEM THEY'RE NOT COMING TO US.
>> Dr. Flaherty: I LOOK AT THE
SECOND PAGE BUT YOU ARE ON MY
FIRST PAGE SO YOU ARE UP.
>> WONDERFUL.
MONICA, I'M SO EXCITED NOT ONLY
ABOUT THE PAYLINE WHICH WE NEED
TO OF COURSE INCREASE.
I'M ALWAYS IN FAVOR OF MORE
GRANTS AND SMALLER GRANTS JUST
AS A LITTLE VOTE.
THE CLINICAL TRIALS INNOVATION
UNIT SOUNDS FASCINATING AND
IMPORTANT AND I HAVE JUST SOME
QUESTIONS ABOUT IT.
SO FIRST OF ALL, IT WILL HELP
WITH INCLUSION, SIMPLIFICATION
OF TRIALS AND SAVE US ALL MONEY,
INCREASE EFFICIENCY AND I'M
WONDERING WHETHER YOU CAN
COMMENT A LITTLE BIT ON THE
PROCESS OF HOW THIS IS DEVELOPED
AND WHETHER THERE'S A RESEARCH
COMPONENT TO IT.
>> SO THE CLINICAL TRIALS
INNOVATION UNIT TAKES IDEAS.
THE IDEAS COME INTO THROUGH THE
NATIONAL CLINICAL TRIALS
NETWORKS LEADERS RIGHT NOW.
THEY CAN PROPOSAL IDEAS AND YOU
CAN PITCH THEM TO ANY OF THE
NCTN LEADERS.
THERE ARE ALSO TWO DIRECTORS OF
THE CLINICAL TRIALS UNIT AND
THEY'RE Dr. SHELIA PRINCIPLE
DA ZEAL AND CLINICAL TRIALS AND
CCT AT NCI AND MICHAEL MOORE IS
WHO IS THE CO DIRECTOR AND WHEN
THEY AGREE TO TAKE ON A STUDY
THE CLINICAL TRIALS INNOVATION
UNIT AGREES TO MAKE IT HAPPEN TO
FIND THE PARTNERS AND DEAL WITH
INDUSTRY AND GET IT ALL TOGETHER
SO THEY'RE NOT GOING TO BE ABLE
TO TAKE THAT MANY.
I AM ANTICIPATING IT'S FIRST
YEAR, WE'LL SEE THREE MAYBE FOUR
NEW STUDIES LAUNCHED BY THE UNIT
OVER VARIOUS AREAS.
BUT LIKE I SAID, AS THIS
HAPPENS, SOME OF THE TOOLS CAN
BE MORE MAINSTREAM AND FIT INTO
OUR RESEARCH AND MECHANISM.
I HOPE THAT ANSWERS YOUR
QUESTIONS.
THE IDEA TO GO TO THE UNIT.
>> VERY QUICK FOLLOW-UP, RATHER
WE DO IMPLEMENTATIONS SCIENCE ON
THE RESEARCH ON THE NEW METHODS
THAT ARE GETTING EMPLOYED
WHETHER IT'S REMOTE SENSOR OR
OTHER ACTIVITIES?
>> ANYTHING IS ON THE TABLE FOR
THAT UNIT.
THEY CAN ABSOLUTELY DO
IMPLEMENTATION SCIENCE, THEY CAN
DO BIOMARKER DEVELOPMENT,
ANYTHING WE NEED TO REACH
PATIENTS AND DO A CLINICAL
RESEARCH FOR IS THERE.
IT'S NOT GOING TO DO
OBSERVATIONAL STUDIES RIGHT NOW.
>> THANK YOU.
>> Dr. Flaherty: LAST QUESTION.
KAREN.
>> THANK YOU, MONICA.
WONDERFUL PRESENTATION.
I AM ALSO GOING TO ASK JUST FOR
SOME MORE VERIFICATION ABOUT THE
CLINICAL TRIALS INNOVATION UNIT.
SO, A LOT OF THE EXAMPLES WERE
SEEMING TO FOCUS ON DEVELOPMENT
OF INNOVATION AROUND TREATMENT
TRIALS AND I'M CURIOUS ABOUT
YOUR PERSPECTIVE ON THE
PRIORITIES OF ENCORE WHICH IS A
LITTLE DIFFERENT FROM THE
PRIORITIES OF THE NCTN GROUPS
WITH CANCER CONTROL STUDIES, SIM
POM MANAGEMENT, PREVENTION
STUDIES AND ALSO CANCER CARE AND
DELIVERY AND ALL OF THAT AND
THERE'S A LOT OF INNOVATION THAT
NEEDS TO BE DONE THERE AND
PARTNERING SO I'M CURIOUS ON
YOUR THOUGHTS ABOUT THAT AND IS
IT PART OF WHAT YOU EXPECT TO
SEE?
>> IF THIS HELPS, TWO IDEAS THAT
ARE CURRENTLY BEING THROWN
AROUND, NOT ACCEPTED YET BUT
JUST GENERAL IDEAS THAT ARE OUT
THERE, ONE OF THEM IS A SYMPTOM
INTERVENTION STUDY THAT IS
REALLY EXCITING AND IT ACTUALLY
MIGHT BE A COLLABORATION WITH
ONE OF THE OTHER NIH INSTITUTES
EVEN WHICH IS REALLY EXCITING.
AND THEN THERE'S ALSO ONE ABOUT
DATA COLLECTION FOR A CLINICAL
TRIAL WITH THE FDA THAT WOULD
USE THE ELECTRONIC HEALTH RECORD
AS THE SOURCE OF THE DATA.
SO THERE'S SOME PRETTY COOL
STUFF HAPPENING AND IT'S NOT
JUST, IT'S NOT JUST TREATMENT.
>> PERFECT.
THANK YOU.
>> THANK YOU, ALL.
THANK YOU, MONICA.
NEXT DEB LOWY IS GOING TO GIVE A
PRESENTATION ENTITLED NCI
RESEARCH PROJECT GRANTS BUDGET
IS BEYOND.
>> Dr. Lowy: THANK YOU, VERY
MUCH.
GOOD MORNING TO YOU.
THIS IS NOT DEJA VU ALL OVER
AGAIN.
BUT I GAVE A SIMILAR TALK TO THE
VSA A YEAR AGO BUT WE THINK THAT
A FAIR AMOUNT HAS HAPPENED AND
THAT IS REFLECTED, FOR EXAMPLE,
IN THE VARIOUS QUESTIONS THAT
YOU HAVE ALREADY ASKED MONICA
AND I JUST WANT TO SAY THAT FOR
ANDY CHAN'S QUESTION, WE ARE
ACTUALLY DEVELOPING DATA LOOKING
AT VARIOUS OPTIONS THAT THE
THANK YOU FOR PUTTING THE
PRESENTATION TOGETHER.
THE NEXT SLIDE TELLS YOU ABOUT
THE THREE AREAS THAT I PLAN TO
COVER IN THE NEXT 15 MINUTES.
ONE THE DISTRIBUTION OF THE
APPROPRIATED THAT DEAD TO THE
POLICIES THAT YOU HAVE ALREADY
SEEN.
THE NEXT TWO SLIDES FOCUS ON THE
NCI BUDGET OVER ALL AND WHAT IS
SHOWN ON THE OUTER PART ARE
REALLY THE DISTRIBUTION OF THE
EXTRAMURAL PARTS WHICH ARE IN
VARIOUS SHADES OF BLUE AND THEN
THE OTHER FUNDING THAT INCLUDES
RESEARCH MANAGEMENT AND SUPPORT
IN THE INTRAMURAL RESEARCH AND
BASICALLY, ABOUT THREE QUARTERS
OF THE FUNDING FROM NCI GOES TO
EXTRAMURAL FUNDING AND ABOUT A
QUARTER TO COVER THESE REALLY
TWO AREAS OF INTRAMURAL
RESEARCH, RESEARCH MANAGEMENT
AND SUPPORT AND ALSO BUILDINGS
AND FACILITIES.
THE NEXT SLIDE SHOWS THE SAME
AREA BUT TO HIGHLIGHT A FEW
THINGS, FIRST, THE RESEARCH
PROJECT GRANTS, THE RPGs
REPRESENT THE SINGLE LARGEST
AMOUNT OF INVESTMENT FOR THE NCI
BUDGET, 44%.
BUT AS SHOWN IN THE TWO BULLET
POINTS ON THE RIGHT, NCI
SUPPORTS A LOT OF RESEARCH AND
OTHER ACTIVITIES THAT ARE
OUTSIDE THE RPG POOL, MONICA HAS
ALREADY ALLU ALLUDED TO SOME BUE
SECOND BULLET, CANCER CENTER
SUPPORT GRANTS, SPORES AND
TRAINING.
THE NEXT SLIDE LOOKS AT WHAT
HAVE WE DONE ESSENTIALLY WITH
THE $1 BILLION INCREASE THAT THE
NCI HAS RECEIVED FROM 2018
THROUGH 2022.
WE'RE NOT INCLUDING 2023 BECAUSE
WE DON'T KNOW EXACTLY WHAT THE
NUMBERS ARE GOING TO BE.
ON THE LEFT, I HOPE YOU CAN
APPRECIATE THAT ABOUT 53% OR
ABOUT $550,000,000.1.072 MILLION
HAS GONE TO THE RPG POOL AND 47%
TO ANOTHER AND JUST REMIND YOU
ON THE OTHER SLIDE, THAT THE RPG
POOL IS 44%.
SO WE'VE ALL OWE INDICATED MORE
FUNDING TO THE RPG POOL THAN TO
THE REST OF THE AREA.
OVER THAT FOUR-YEAR PERIOD, THE
PREPORTION OF THE RPG POOL HAS
GONE FRIENDSHIP 41 TO 44 PERCENT
AND THIS REPRESENTS AN AVERAGE
OF ABOUT $140 MILLION OF THE 260
FOR THE INCREASES THAT WE'VE
SEEN ON AVERAGE IN THE LAST FOUR
YEARS.
THE PERCENTAGE IS PROJECTED TO
INCREASE FURTHER IN '23 BUT
WE'RE NOT INCLUDING IT BECAUSE
WE DON'T KNOW THE PRECISE
AMOUNT.
THE NEXT FEW SLIDES TALK ABOUT
THE RPG POOL TRENDS.
THE NEXT SLIDE, THERE ARE FOUR
SLIDES IN THIS PART.
INDICATES WHAT WE SAW ABOUT FIVE
OR SIX YEARS AGO WHICH WAS THE
RATE OF APPLICATIONS AND NUMBER
OF APPLICANTS TO NCI WENT UP
FASTER THAN THE NUMBER OF
APPLICATIONS AND APPLICANTS FROM
OTHER INSTITUTES AND CENTERS AND
AS OF 2022, BETWEEN 2013 AND '2Y
APPLICANTS IN TERMS OF THE
INCREASE AND NCI AND THE NEXT
SLIDE, SHOWS WHAT HAS HAPPENED
REALLY OVER THE LAST COUPLE OF
DECADES FOR FUNDING WITH THE RPG
AND THIS IS NOT A PAYLINE, THIS
IS SUCCESS RATES OKAY AND THE
BLUE IS THE NIH AND THE ORANGE
IS NCI.
WHAT I THINK YOU WANT TO SEE AND
APPRECIATE IS THAT DURING THIS
TIME, THAT THERE WAS THIS
SUBSTANTIAL INCREASE IN THE
NUMBER OF APPLICATIONS AND OUR
FUNDING OF ACTUALLY OUR SUCCESS
RATES WENT DOWN AND THEY HAD
GONE UP OVER THE LAST FEW YEARS
BUT NOT AS HIGH AS NIH PART OF
THAT IS ACCOUNTED FOR BECAUSE WE
SUPPORT RESEARCH OUTSIDE OF THE
RPG AREA WHERE THE RPG PORTION
ACCOUNTS FOR A SUBSTANTIALLY
HIGHER PERCENTAGE FOR MANY OTHER
INSTITUTES AND CENTERS.
SO THIS SLIDE DEPICTS WHAT
HAPPENED FOR EARLY STAGE
INVESTIGATORS AND IN THE GREEN
OR THE TOTAL NUMBER OF AWARDS
THAT WERE MADE EACH YEAR TO THE
EARLY STAGE INVESTIGATORS AND IN
BLUE, THE PAYLINE FOR THE
AEROMEXICO STAGE INVESTIGATORS
FOR EACH OF THE YEARS.
I HAVE OUTLINED IN THE RED
RECTANGLE, 2019 BECAUSE I WANT
YOU HAD TO USE THAT AS A
REFERENCE POINT FOR THE
EXPERIENCED INVESTIGATORS THAT
YOU WILL SEE ON THE NEXT SLIDE.
BUT BEFORE WE GO THERE, THE
NUMBER OF AWARDS THAT WE'VE BEEN
ABLE TO MAKE TO AEROMEXICO STAGE
INVESTIGATORS HAS REALLY GONE UP
SUBSTANTIALLY SINCE THE 2016 AND
2017 AREA GOING FROM THE 80s
TO THE 130s.
THE NEXT SLIDE SHOWS YOU WITH
EXPERIENCED INVESTIGATORS, THAT
THE NUMBER OF AWARDS THAT WE'VE
BEEN ABLE TO MAKE HAS GONE UP
AGAIN PARTICULARLY SINCE 2019
WHEN WE HAD THIS LOW PAYLINE OF
8% AND THAT YEAR WE ACTUALLY THE
ESIs WERE 6 PERCENTAGE POINT
HIGHER FOR THE SWEPT YEARS IT'S
BEEN 5% POINTS HIGHER AND AS
MONICA POINTED OUT, WE
ANTICIPATE A SUB T SUBSTANTIAL
INCREASE IN THE TOTAL NUMBER OF
AWARDS IN 2023 BUT WE DON'T KNOW
THE NUMBERS BECAUSE WE'RE STILL
REALLY JUST THE FIRST HALF OF
THE FISCAL YEAR.
I NOW HAVE FIVE SLIDES FOR
CONSIDERATION OF FY23.
THE FIRST SLIDE IS BASICALLY
WHAT YOU HAVE SEEN ALREADY FROM
MONICA'S PRESENTATION WHERE THE
ESTABLISHED INVESTIGATORS OF THE
12% EARLY STAGE INVESTIGATORS,
17th% AND SHE DIDN'T MENTION
BUT THE R21s NINTH PERCENTILE
AND THE COMPETING GRANTS AT 98%
SO LET'S GO THROUGH THIS TO TRY
TO UNDERSTAND BETTER HOW WE GOT
THERE.
NEXT SLIDE.
SO, EACH YEAR, THIS ARE TWO OVER
ALL INVESTMENT CATEGORIES WITHIN
THE RPG POOL.
THE COMPETING AWARDS ORCHARD
REFOR THE NEWAWARDS AND THE SECE
NON COMPETING AWARDS OR THE
OUT-YEAR AWARDS.
TO PRIORITIZE FUNDING MORE NEW
AWARDS, WE GENERALLY FUND ONLY
THE FIRST YEAR OF THE AWARDS
WHEN THEY ARE MADE, HOWEVER,
THEY'RE MORE THAN ONE YEAR.
THE R56 AWARDS ARE NOTABLE
EXCEPTION JUST ONE YEAR BUT
MOSTLY THE VAST MAJORITY ARE
MORE THAN ONE YEAR AND THE
AVERAGE LENGTH IS FIVE YEARS AND
GO THROUGH SOME OF THE
IMPLICATIONS OF THAT.
NEXT SLIDE.
WE HAVE TWO MAIN FUNDING SOURCES
FOR THE RPG POOL.
ONE IS THE TURNOVER FUNDS FROM
THE NON COMPETING RPG AWARDS
THAT WERE COMPLETED IN THE.
PRIOR YEAR.
IF EVERYTHING WERE AT STUDY
STATE THAT WOULD BE SUFFICIENT.
THAT'S NOT SUFFICIENT AND SO WE
NEED TO AT FUNDS FROM THE NCI
APPROPRIATION BECAUSE TURNOVER
DOLLARS ARE INSUFFICIENT.
THE THE AVERAGE COST OF EACH
COMPETING AWARD WILL BE HIGHER
THAN THE COST OF EACH COMPLETED
AWARD.
AND THIRD, THE OUT YEAR COST OF
MULTI-YEAR AWARDS.
MONICA SHOWED YOU THE STAIR STEP
NOTION THAT WE NEED TO ADD MORE
FUNDING EACH YEAR IN ORDER TO
COVER THE OUT YEAR COST.
I NOW WANT TO GO TO THE NON
COMPETING AWARDS.
WHY MIGHT WE FUND THEM AT LESS
THAN 100% OF THE COMMITMENT
LEVEL?
THE FIRST BULLET TELLS YOU NCI
CONSIDERS THIS OPTION WHEN THE
FUNDS FROM TURNOVER COMPLETED
AWARDS PLUS FROM NCI
APPROPRIATIONS ARE I AM
SUFFICINSUFFICIENT.IT'S WHETHERS
THAT IS HAVING A HIGHER PAYLINE
OR TO PRIORITIZE FUNDING NON
COMPETING GRANTS AND ARE 100%
AND WE'VE CONSULTED WITH YOU AND
NCAB IN THE PAST AND WE ARE
USUALLY PRIORITIZING FUNDING
MORE COMPETING AWARDS BECAUSE
THAT SEEMS TO BE THE SENSE OF
THE COMMUNITY.
NEXT SLIDE.
THESE ARE SOME COLLAR DOLLAR
CONSIDERATIONS.
THE RPG PEOPLE AT THE END OF
2022, WAS $2.89 BILLION.
THE RO1s MAKE UP 60% OF THE
TOTAL RPG POOL.
EACH TIME WE INCREASE OR
DECREASE THE PAYLINE BY A
PERCENTILE POINT, WE ARE ADDING
OR SUBTRACTING ABOUT
$33 MILLION.
AND WHEN WE ARE LOOKING AT THE
NON COMPETING PERCENTILE, THAT
PERCENT IS $21 MILLION SO THESE
VARIOUS CONSIDERATIONS ARE WHAT
LEAD US TO MAKE THE DECISIONS.
THE FINAL SLIDE, REALLY IS THE
SUMMARY.
FIRST, NCI HAS PRIOR TASED RPG
FUNDING ABOUT $550 MILLION HAS
BEEN ADDED TO THE RPG POOL
DURING THE FOUR YEARS BETWEEN
2018 AND '22.
EXTRAMURAL FUNDING RESEARCH LIES
OUTSIDE THE RPG POOL AND NCI HAS
NOT NEGLECTED THE OTHER PARTS OF
THIS RESEARCH PORTFOLIO.
THANK YOU VERY MUCH AND I THINK
WE HAVE A FEW MINUTES FOR
QUESTIONS AND COMMENTS.
>> Dr. Flaherty: THANK YOU,
DOUG.
QUESTIONS?
>> THANK YOU, DOUG.
COULD YOU COMMENT MORE ABOUT THE
DENOMINAT OR AND THE NUMBER OF
APPLICATIONS COMING TO THE NCI?
>> Dr. Lowy: THE NUMBER?
>> YEAH.
>> Dr. Lowy: WE GET, I HOPE I'M
CORRECT, WE GET AROUND 3500
APPLICATIONS EACH YEAR THE
SUCCESS RATE IS ABOUT 14% AND SO
THE SUCCESS RATE FOR RPGs IS
WE GET ABOUT 800 SO PROBABLY
ABOUT 400,000 TO 5,000
APPLICATIONS.
>> I MEANT THE TRENDS AND HOW IT
COMPARES TO THE OTHER
INSTITUTES?
>> Dr. Lowy: I'M SORRY, BOB, THE
TRENDS ARE THAT HOURS HAVE BEEN
FLAT FOR THE LAST COUPLE OF
YEARS.
WE CAN SEE THE INTERPRETED WHEN
WE LOOK AT THE RELEVANT SLIDE.
>> YOU HAVE A COMMENT?
>> YES, THANK YOU, DOUG.
I WAS JUST CURE BUS THE R37
GRANTS.
IT MAY BE TOO EARLY TO SEE WHAT
THE IMPACT IS INTENSE ON FUNDING
BUT ONE -- THAT --
>> THAT'S A VERY IMPORTANT
QUESTION.
WE INSTITUTED THAT POLICY A
NUMBER OF YEARS AGO BECAUSE WE
WANTED EARLY STAGE INVESTIGATORS
TO HAVE AN EVEN GREATER
OPPORTUNITY TO TRY TO MAKE AN
IMPACT WITH THEIR FIRST AWARD.
AND WHAT HAPPENS IS THAT IT'S
NOT AUTOMATIC THAT EVER FIVE
YEARS THAT THEY GO TO THE EXTRA
TWO YEARS.
THEY WRITE A PROGRESS REPORT AND
THEN ENCLOSED SESSION AND I'M
PLEASED TO TELL YOU THAT THE
PROBLEM THAT THE VAST MAJORITY
OF THE PEOPLE WHO ARE ELIGIBLE
THUS FAR FOR THE R37, THEIR
PROGRESS HAS THEY'RE GERMANE TO
THIS STATISTIC THAT YOU
QUOTED -- I DID NOT APPRECIATE,
YOU CHANGED THE FUNDING LINE BY
ONE POINT OR ONE PERCENT YOU
SAID AND IT'S SEVERAL BILLION
DOLLARS OF EFFECT, IF I REMEMBER
THAT SLIDE.
THAT TO ME WAS EYE-OPENING AND I
WAS SITTING HERE TRYING TO THINK
OF HOW THAT CAN POSSIBLY BE SO
IF IT'S 1%, OF 3,500 GRANTS
WHICH IS WHAT THE ANSWER WAS TO
BOB'S QUESTION, THAT WOULD ONLY
BE 35 GRANTS.
SO UNDERSTANDING THAT THE LINK
BETWEEN THE 1% AND THE 3 BILLION
WOULD BE EYE-OPENING.
IT IS CERTAINLY A SHOCKING
STATISTIC.
>> Dr. Lowy: YEAH.
SO, THE THE NEW AWARDS THAT WE
MAKE EACH YEAR, ABOUT 60% OF
THEM ARE RO1 OR RO1 AWARDS.
AND THE 33 MILLION IS REALLY FOR
EACH PERCENT STYLE SO IF WE'RE
AT, TO USE AN EASY NUMBER AND
THAT WOULD BE IT'S NOT THAT EACH
PERCENTILE IS NOT BUT THAT'S
WHAT IT COMES DOWN TO SO THIS --
YOU KNOW, BASICALLY, FOR THE
12%, YOU ARE TALKING ABOUT
$66 MILLION PLUS THE 300 SO IN
ROUND FIGURES IT'S $400 MILLION
IN NEW RO1 AWARDS.
>> THANK YOU, IT'S A STRIKING
STATISTIC.
>> BUT WHAT IS EQUALLY IMPORTANT
IS THE NUMBER OF INCREDIBLY
OUTSTANDING APPLICATIONS THAT WE
CAN'T FUND.
AT 129% THEY WERE JUST SO MANY
HOW DO YOU DIS TICK WISH AND TO
BE POSITIVE I'VE QUOTED SUCCESS
RATE OF 13% AND I THINK --
>> THIS IS FOR ALL AWARDS.
THIS IS NOT JUST THE RO1s.
>> YEAH.
>> 10% OF RO1s WERE 14% I
BELIEVE LAST YEAR.
SHERRI, THIS NEEDS TO BE THE
LAST QUESTION, I'M SORRY.
>> Dr. Flaherty: THANK YOU.
ASK YOUR QUESTION.
>> I DID.
I SAID THAT YOU CLOSED THE GAP.
>> Dr. Lowy: OH, I'M SORRY.
>> AND NOW IT'S JUST 15 AND 21
SO WE ARE MOVING IN THE RIGHT
DIRECTION.
>> Dr. Lowy: YEAH.
KEITH, BACK TO YOU.
>> Dr. Flaherty: THANK YOU,
DOUG.
NOW, ON TO THE LEGISLATIVE
REPORT.
M.K. HOLOHAN.
>> Ms. Holohan: YOU HAVE IF
QUESTIONS THAT I DON'T COVER
HERE OR WE DON'T HAVE TIME TO
GET TO QUESTIONS, PLEASE REACH
OUT TO ME AND WE'RE HAPPY TO
TALK WITH YOU OR YOUR STAFF.
NEXT SLIDE, PLEASE.
I'M GOING TO TOUCH ON THESE FOUR
TOPICS TODAY.
THE DEBT LIMIT AND BUDGET
NEGOTIATIONS THAT JUST RELEASED
PRESIDENT'S BUDGET REQUEST FOR
FISCAL YEAR 2024 AND IT TEES OFF
THE CONGRESSIONAL APPROPRIATIONS
PROCESS AND THEN A WORD ABOUT
OVERSIGHT IN THIS 118
118th CONGRESS.
NEXT SLIDE, PLEASE.
SO THE DEBT CEILING GAME OF
CHICKEN BEGINS.
SO, DEBT LIMIT INCREASES ARE
ROUTINE.
THEY PASS IN ALL SORTS OF
ADMINISTRATIONS RND
ADMINISTRATIONS AND THEY DO
BECOME LEVERAGE FOR DEAL-MAKING.
THE URGENCY OF A DEBT LIMIT.
AND THE IMPENDING X DATE OF THE
TREASURY REFERS TO IT IT SERVING
AS LEVERAGE AND CREATES URGENCY
AND THERE'S BEEN -- A DEBT LIMIT
INCREASE HAS BEEN PART OF THE
CALCULATIONS FOR MOST OF THE THE
BIG BUDGET DEALS WE'VE SEEN IN
THE MODERN HISTORY OF THE
CONGRESS AND THE BUDGET CONTROL
ACT OF 2011 THAT SETS SPENDING
CAPS FOR 10 YEARS.
THIS WERE LOTS OF OTHER
CONDITIONS, SOME INVOLVED
PROCESS AND UNDERSTANDABLY MANY
MEMBERS HAVE BEEN FRUSTRATED
ABOUT ONLY GETTING TO SEE THESE
HUGE OMNIBUS BILLS.
UP WITH OF THE PROBLEMS THAT WAS
GOING TO BE THAT THEY DON'T MOVE
12 BILLS THROUGH FOR EACH
SUBCOMMITTEE SEPARATELY AND THAT
JUST TAKES A LOT OF TIME.
WE'LL GO TO THE NEXT SLIDE,
PLEASE.
SO, THE PRESIDENT RELEASED HIS
FY24 BUDGET REQUEST LAST WEEK
AND THIS WAS A BIT LATER THAN
NORMAL USUALLY IT'S A MONDAY AND
FIRST MONDAY IN FEBRUARY AND
COME RIGHT AFTER THE STATE OF
THE UNION AND FY23 WASN'T
COMPLETED UNTIL THE END OF THE
CALENDER YEAR SO SINCE BLEE
THERE NEEDED TO BE MORE TIME AND
DEVELOPING THE BUDGET REQUEST
AND SO UP WITH OF THE THINGS
THAT WE SEE HERE ARE THE BUDGET
REALLY SHOWCASE AND YOU'VE HEARD
PRESIDENT BIDEN SAY THIS, DON'T
TELL ME WHAT YOU VALUE SHOW ME
YOUR BUDGET THAT TELLS ME WHAT
YOU VALUE WHAT THIS BUDGET CALLS
FOR NEW INVESTMENT IN CLEAN
ENERGY AND CLIMATE SCIENCE AND
NEW TECHNOLOGIES.
A LOT OF IT IS PAID FOR BY TAX
INCREASES ON THE WEALTHIEST
AMERICANS AND CORPORATIONS AND
TAX CREDIT ROLL BACKS AND SOME
OF THE BUDGET PROVISIONS AND
ANTICIPATE SAVINGS FROM
NEGOTIATING PRESCRIPTION DRUG
PRICES AND SO AS YOU WOULD
EXPECT, THEY'RE IMMEDIATE
IDEOLOGICAL CLASHES.
HOUSE REPUBLICANS HAVE RULED OUT
ANY NEW TAXES AS A SOLUTION TO
THE FEDERAL DEBT, MUCH LESS IN A
NEW BUDGET PROPOSAL.
THIS BUDGE WET PROPOSE A 3.2%
INCREASE FOR DEFENSE THAT NUMBER
IS NOT GOING TO BE ACCEPTABLE TO
REPUBLICANS.
ONE THING WORTH CONSIDERING,
WHEN LOOKING AT THE IT WOULD BE
AN 8% CU 8 CUT WITH FY '23 AND S
NOT THAT ONEROUS.
IF YOU TAKE OUT VETERANS
PROGRAMS AND DEFENSE, WHICH THEY
WOULD NOT CUT, YOU ARE LOOKING
AT A 22% CUT WITH ALL THE
DISCRETIONARY SPENDING AND
THAT'S VERY SIGNIFICANT.
SO, THAT SORT OF THE FRAMEWORK
AND THE MIND SET IN WHICH THIS
PRESIDENT'S BUDGET PROPOSAL IS
BEING RECEIVED.
ONE PART OF THIS BUDGET THAT THE
PRESIDENT HAS MADE VERY CLEAR IS
THAT HE WANTS TO PROPOSE A UNITY
AGENDA PROGRAMS SORT OF SELECT
PIECES OF THE BUDGET REQUEST
THAT COULD HAVE BIPARTISAN
SUPPORT AND THE CANCER MOONSHOT
AND THE GOAL OF REDUCING CANCER
DEATHS BY 50% IN 25 YEARS IS ONE
ASPECT AND ANOTHER IS MENTAL
HEALTH INVESTMENTS AND VETERAN
PROGRAMS AND INVESTMENTS INTO
OPIOID DEPOSIT EPIDEMIC.
SO LOOKING AT THE PAST TWO
YEARS, WHAT YOU CAN SEE HERE IS
SORT OF THE NUMBERS THAT HAVE
BEEN PUT FOURTH FOR NCI AND NIH
OVER ALL AND ARPA-H.
THIS IS NEW AGENCY WHICH NOW
SITS WITHIN NIH THAT O CH COULDF
THERE'S AUTHORIZATION
LEGISLATION THAT CHANGES WHERE
IT SITS BUT THAT'S WHERE ARPA-H
IS.
AND I HAVE THEIR NUMBER SEVEN
RAT BECAUSE IT'S INTERESTING TO
SEE THE PROPOSED GROWTH OF THAT
AGENCY.
AND SO WHAT WE CAN SEE FOR
FY2024 IS FOR NCI THE PROPOSAL
WOULD CONTINUE THE $216 MILLION
THAT WE'RE RECEIVING FY2 FOR THE
CANCER MOONSHOT SO TAKEAWAY THAT
FUNDING CLIFF FOR NEXT FISCAL
YEAR AND IT PROPOSES AN
ADDITIONAL $500 MILLION FOR
CANCER MOONSHOT ACTIVITIES AND
SO THIS IS SORT OF THE SECOND
VERSION OF THE CANCER MOONSHOT.
AND THAT THIS WOULD BE ALL OF
GOVERNMENT APPROACH THAT Dr.
BERTAGNOLLI DESCRIBED IN HER
PRESENTATION.
THE OVER ALL INCREASE IS 1%
INCLUDING THE MONEY THAT'S BEEN
PROPOSED FOR NCI CANCER MOONSHOT
AND ARPA-H THERE'S ANOTHER
BILLION DOLLARS PROPOSED ANOTHER
THING THE PRESIDENT'S BUDGET
PROPOSES AND NOW THE PRESIDENT'S
BUDGET IS AT ITS CORE A PROPOSAL
FOR DISCRETION FUNDING FOR THE
COMING FISCAL YEAR AND IT'S ALSO
A MESSAGING DOCUMENT AND IT GOES
IN MANY OF THE PROTECTIONS THAT
INCLUDES SOME OF THEIR DEBT
REDUCTION AND SOME OF THEM ARE
ABOUT INVESTMENTS IN BROAD
PROGRAMS AND SO THIS THIS
PROPOSES MAPPED TORI FUNDING FOR
THE CANCER MOONSHOT FOR FY25 AND
AND HOWEVER, REAUTHORIZATION
SORT OF SUGGESTS OR IMPLIES THAT
SOMETHING A BILL NEEDS TO BE IT
IS FOR EXAMPLE FDA USER FEE
LEGISLATION AND IT'S MUSS PASS
LEDGETATLEDGETATION SO WHAT WE'E
LOOKING AT REAUTHORIZATION OF
THE NATIONAL NOT APPROPRIATORS
AND MIGHT INCLUDE A SPECIFIC
SECTOR FOR THE NATIONAL CANCER
ACT THAT MIGHT INCLUDE OTHER
SECTIONS RELATED TO BIO MEDICAL
RESEARCH AND IT COULD BE NIH AND
FDA AND IT COULD BE CDC AND LOTS
OF DIFFERENT PIECES AND COULD BE
ROLE INTO THAT.
ONE OF THE THINGS THAT I WANT
TODAY MAKE A POINT OF IS WHAT WE
REALLY HAVE SEEN IN THIS BUDGET
PROPOSAL IS THAT THE CANCER
MOONSHOT, AS ENVISIONED BY THE
ADMINISTRATION IS NOT LIMITED TO
JUST NCI.
AS Dr. BERTAGNOLLI EXPLAINED,
THIS IS PERCEIVED AS AN ALL OF
GOVERNMENT APPROACH WITH LOTS OF
COLLABORATION AND I JUST PULLED
A FEW EXAMPLES HERE.
THESE WERE KIND OF WITHIN EACH
OF THESE DIFFERENT AGENCIES,
BUDGET SECTIONS AND SO YOU CAN
SEE THIS 716 MILLION BEING
PROPOSED FOR NCI AND THERE'S
20 MILLION FOR HER SA,
180 MILLION FOR THE INDIAN
HEALTH SERVICE AND 70 MILLION
FOR IMPLEMENTATION OF THE PACKED
ACT AND $15 MILLION FOR CDC AND
FOR SOME SCREENING AND SO ON AND
ANOTHER THING THAT WE SAW IN
THIS BUDGET REQUEST WHICH IS
NEW, IS A PROPOSAL TO ELIMINATE
HEPATITIS C AND A MAJOR RISK
FACT OR FOR LIVER CANCER AND
THAT IS FOR MANDATORY FUNDING SO
THERE'S GOING TO BE A TALL
HURDLE THERE.
THIS IS SOMETHING NCI HAS BEEN
PAYING ATTENTION TO FOR MANY
YEARS AND EXPLORING FOR MANY
YEARS SO WE'RE PLEASED TO SEE
THE ATTENTION TO THIS IDEA OF
PREVENTING LIVER CANCER WITH
HEPATITIS C TREATMENT.
>> REGARDLESS OF SORT OF THE MID
RECEPTION IT'S EXCITING TO SEE
FRESH APPROACH AND CANCER
RESEARCH FOR OUR COMMUNITY.
NEXT SLIDE, PLEASE.
AND I WAS GOING TO SAY TOO, EVEN
WHEN THE PRESIDENT AND THE
CHAMBERS OF CONGRESS ARE THE
SAME PARTY WE NEVER SEE CONGRESS
APPROPRIATING EXACTLY WHAT THE
PRESIDENT REQUESTS.
APPROPRIATORS TAKE THEIR JOBS
VERY SERIOUSLY AND THEY TEND TO
BE A LESS PARTISAN GROUP THAN I
THINK I COMMENTED IN ONE OF THE
LAST BOARD MEETINGS THAT THEY'RE
APP OLD SAYING IN D.C. THAT
THERE'S DEMOCRATS, REPUBLICANS
AND APPROPRIATORS.
TO THE EXTENT IT'S TRUE IN ALL
GOVERNMENT AGENCIES.
THIS SLIDE SHOWS THE TWO LEADERS
OF THE HOUSE PRO PRE AIGS
COMMITTEE AND THEY ARE SEASON
VETERANS AND LONG TIME
COLLEAGUES AND THEY HAVE A LOT
OF RESPECT FOR ONE ANOTHER.
THEY HAVE A TOUGH JOB.
YOU MAY KNOW ON THE SENATE SIDE,
THERE ARE ANOTHER TWO SET OF
LONG TIME COLLEAGUES WHO ARE
BOTH WOMEN AS WELL WHO ARE IN
CHARGE OF THE SENATE
APPROPRIATIONS COMMITTEE.
SENATOR PATTY MURRAY OF
WASHINGTON STATE AND SUSAN
COLLINS OF MAIN AND TH OF MAINE.
THIS IS THE FIRST TIME THEY'VE
BEEN WOMEN AND THEY HAVE BEEN
HAPPENED A VERY DIFFICULT TASK
FOR FY24 AND I WISH THAT THIS
GROUP HAD A LITTLE BIT MORE
BREATHING ROOM WITH WHAT THEY'RE
TRYING TO DO AND I WANTED TO
SHOW YOU IN THIS SLIDE, KAY
GRANGER, THE CHAIR OF THE
APPROPRIATIONS COMMITTEE HAS
BEEN CLEAR-CUTTING DEFENSE WON'T
HAPPEN WHEN SHE'S THE CHAIR OF
APPROPRIATIONS AND
CONGRESSWOMAN, THE RANKING
MEMBER, HAS MADE THE COMMENT
ABOUT THIS DEAL TO RETURN TO
FY22 LEVELS AND YOU CAN PASS PRO
PRE ALLEGATIONS BILLS IN THAT
WAY.
THE PRESIDENT WON'T SIGN THEM
AND THEY'RE NOT GOING TO GET
THROUGH COMMITTEE AND SHE MADE
THESE COMMENTS FAIRLY EARLY
SAYING IF YOU INSIST ON THIS AND
PROCEED WITH THAT GOAL, YOU WILL
BE LOOKING AT A SHUT DOWN.
WE'LL GET TO PREDICTION THIS IS
A MOMENT.
I WANT TODAY POINT OUT THAT
CHAIRMAN GRANGER ACTUALLY HAS A
VERY DIFFICULT TASK BECAUSE
AMONG THE CONCESSIONS THAT WERE
MADE BY SPEAKER McCARTHY,
EARLIER ON AS HE WAS TRYING TO
GET VOTES TO BE SPEAKER, HE
AGREED TO AN OPEN AMENDMENT
PROCESS AND THAT'S A LINT OF
PROCEDURAL DETAILS THAT IS ONLY
IMPORTANT FOR OUR CONVERSATIONS
IN THAT USUALLY LEGISLATION IS
CONSIDERED IN THE HOUSE UNDER A
CLOSED RULE.
SO YOU CANNOT HAVE EVERY MEMBER
OF THE HOUSE OFFERING AMENDMENTS
TO A PIECE OF LEGISLATION IN
SOME WAYS, SOMETIMES PEOPLE WANT
TO OFFER AMENDMENTS TO MAKE
THEIR OWN POINT TO FORCE THEIR
COLLEAGUES TO TAKE A VOTE ON
SOMETHING AND DEMOCRATS HAD AN
OPEN PROCESS BACK IN THE -- I
KNOW IT WAS -- IT ENDED IN 2009
WHEN THEY GAVE UP ON IT BECAUSE
IT JUST TOOK WAY TOO MUCH TIME.
SO IF YOU ARE GOING TO BE ON THE
HOUSE FLOOR WITH THE BILL AND
YOU HAVE OPEN AMENDMENTS AND
OPEN RULE PROCESS YOU WILL SPENE
TO GET THE BILL THROUGH THE RULE
COMMITTEE AND THROUGH THE HOUSE.
THAT'S GOING TO MAKE
CONGRESSWOMAN, CHAIRWOMAN
GRANGER'S JOB MUCH MORE
DIFFICULT MOVING THESE BILLS,
ESPECIALLY SINCE HER KOUAKOU HEO
CUT $150 BILLION THROUGH THE
LEVELS.
SHE KNOWS THE GOP COLLEAGUES AND
THE PRESIDENT AS COPYING RECEIPT
WOMAN DELAURO POINTS OUT THE
GOVERNMENT WON'T SIGN A BILL
LIKE THAT.
THIS IS A TOUGH JOB FOR THESE
TWO LEADERS.
I WANTED TO POINT OUT THAT WE
ACTUALLY HAVE NEW LEADERSHIP IN
THE SENATE LEADERSHIP HHS
SUBCOMMITTEE AND WE HAVE WE WE
COVERED THE NEW CHAIR IS ROBERT
ADDERHOLT FROM ALABAMA HE WAS
CHAIR OF THE THE AG SUBCOMMITTEE
AND LONG TIME EXPERIENCES
APPROPRIATOR AND CONGRESSWOMAN
DELAURO WAS THE RANKING POSITION
AND THEY KNOW EACH OTHER VERY
WELL FROM SERVED ON THE AG
COMMITTEE AND BEEN ON CONGRESS
FOR YEARS AND YEARS TOGETHER.
ON THE SENATE SIDE, SENATOR ROY
BANKBLUNT RETIRED AND THE RANKIG
MEMBER IS SHELLY MOORE CAPITO
AND TAMMY BALDWIN MOVED UP TO
SHARE THE CHAIR AND WAS NOT
GOING TO BE KEEP THIS
SUBCOMMITTEE GAVEL AS WELL.
SO THESE TWO MEMBERS, THESE TWO
SENATORS HAVE BOTH BEEN REALLY
STRONG SUPPORTERS OF BIOMEDICAL
RESEARCH AND BOTH HAVE VISITED
NCI IN RESENT YEARS AND SENATOR
CAPITO HAS BEEN A BIG SUPPORTER
OF CHILDHOOD CANCER RESEARCH SO
WE'RE PLEASED TO BE HAVING THESE
LEADERS IN POSITIONS WORKING
WITH THEM AND THERE'S A FEW NEW
MEMBERS ON THE SUBCOMMITTEE ON
THE REPUBLICAN SIDE AS WELL.
SO IN TERMS OF WHAT IS GOING TO
HAPPEN NEXT, THERE ARE BUDGET
HEARINGS HAPPENING AT A REALLY
FAST PACE RIGHT NOW.
SECRETARY VA SER A HAS HEARINGS
THIS WEEK AND THE OMB DIRECTOR
YOUNG HAS BEEN ATTENDING
CONGRESSIONAL HEARINGS.
WE'LL SEE ALL THE SECRETARY
CABINET LEVEL HEARINGS HAPPENING
AT FIRST.
TIME IS VERY TIGHT SO THERE MAY
NOT BE THE SAME NUMBER OF
HEARINGS AS WE HAVE SEEN IN
RESENT YEARS.
YOU KNOW, WE NEVER EXPECTED
FUNDING BILLS TO BE ENACTED
BEFORE THE START OF THE FISCAL
YEAR AND WHEN IT HAS HAPPENED
ONCE IN RESENT YEARS, I THINK IT
WAS Dr. SHARPLESS' FIRST YEAR
AS DIRECTOR AND HE WAS SURPRISED
WHEN OUR BILL WAS COMBINED WITH
DEFENSE AND THEY BOTH WENT INTO
WERE ENACTED BEFORE THE START OF
THE FISCAL YEAR BUT THAT HADN'T
HAPPENED FOR DECADES BEFORE AND
IT HASN'T HAPPENED SINCE.
WE SORT OF EXPECT CONTINUING
RESOLUTIONS.
WE REALLY DON'T KNOW HOW LONG.
THERE'S BEEN SOME REPORTING THAT
THERE MAY BE SOME SHORT TERM
DEBT LIMIT INCREASES IN ORDER TO
BUY MORE TIME FOR THE
APPROPRIATIONS PROCESS TO PLAY
OUT SO THEY'RE NOT GOING TO BE
UP AGAINST A WALL FOR BOTH DEBT
LIMIT VOTE AND CONTINUE
RESOLUTION TO KEEP THE
GOVERNMENT OPEN.
WE REALLY DON'T KNOW WHAT WILL
HAPPEN.
YOU WILL HEAR A LOT OF DIRE
PREDICTIONS ABOUT THE SHUT DOWNS
AND FULL UCRs.
YOU KNOW, DEFENSE HAS NEVER HAD
A FULL YEAR RC BECAUSE THERE'S
ALWAYS BEEN AN JUSTMENT OF SOME
KIND TO ALLOW THEM TO HAVE AN
INCREASE AND THERE'S
COMBINATIONS WE CAN SEE
HAPPENING.
THERE COULD BE AN OMNIBUS
SPENDING BILL THAT KEEPS
ACCOUNTS AND AGENCIES FLAT
FUNDED LIKE A CR WOULD.
THAT DOES INCREASE FOR CERTAIN
PROGRAMS.
OBVIOUSLY WE WOULD BE HOPING
CANCER RESEARCH WOULD BE ONE OF
THOSE PROGRAMS THAT COULD BE
SUPPORTED BY BOTH PARTIES AND
DEFENSE AND WE HAVE TO GET SORT
OF INCREASED REQUESTED IN THE
BUDGET PROPOSAL IF THIS IS GOING
TO GET BIPARTISAN SUPPORT AND WE
REALLY WHAT IS GOING TO HAPPEN
FROM THIS IS MUCH AS THE
ADMINISTRATION AND NEVER WANTS
TO ANY ADMINISTRATION NEVER
WANTS TO NEGOTIATE.
JUST A QUICK WORD ABOUT
OVERSIGHT AND YOU MAY HAVE SEEN
REPORTING, THIS WAS A HEARING
EARLY FEBRUARY.
Dr. TABAK AND CDC AND FDA
LEADERSHIP TESTIFIED AT A
HEARING THAT ENERGY AND COMMERCE
HELD ABOUT THE FEDERAL RESPONSE
TO COVID AND WE SAW ANOTHER
HEARING MAYBE TWO WEEKS AGO AND
THE COMMITTEE ON OVERSIGHT AND
ACCOUNTABILITY AND THESE ARE
BOTH HOUSE COMMITTEES ABOUT THE
ORIGINS OF THE NOVEL
SARS-CoV-2 VIRUS AND LAB LEAKS
VERSUS OTHER SORT OF IDEOLOGY.
THIS IS NOT AND THIS IS BEEN
SOME AND THEY WERE PUSHED AND
THERE WAS A THAT COULD BE DONE
AND THE FEDERAL AGENCIES AND IN
THE EXTREME CIRCUMSTANCES THEY
WERE FACING AND OTHER THINGS
THAT HAVE LED IF THERE'S
AUTHORIZATION LAW DEVELOP THAT
WOULD TOUCH ON THE HEALTH SECTOR
AND IN A CURES REAUTHORIZATION
OF THE CURES ACT, THERE MAY BE
SOME SORT OF CODIFICATION OF
OVERSIGHT PRE VISION THIS IS
THAT AND NOT NECESSARILY NEW
AUTHORITIES BUT JUST RESTATEMENT
OF KIND OF THE OVERSIGHT
RESPONSIBILITIES AND MAYBE
REPORTING.
WE MUCH SEE THAT SORT OF THING.
THIS IS MY LAST SLIDE.
>> THANK YOU FOR THE UPDATES.
I GUESS I WAS CURIOUS GOING BACK
TO THE EARLIER CONVERSATIONS
AROUND LABEL COST AND HOW BEST
FACTORING INTO THE BUDGET AND
THEY MAY SAY IN THIS SIDE BAR.
>> I'M NOT SURE I UNDERSTAND THE
QUESTION.
>> THE LABOR COSTS ARE ALL-TIME
HIGH AND INFLATION IS A BIG
ISSUE AND I GUESS GOING BACK TO
THE QUESTION ABOUT THE PRESSURES
AND RESEARCH ENVIRONMENTS AND
IT'S NOT GOING TO BE ME IN FRONT
OF THIS PROCESS.
SO, I JUST WAS CURIOUS ABOUT HOW
CONSIDERATIONS ABOUT THE COST
INFLATION THAT CAN FACTOR INTO
THIS OVER ALL THEATER AS I
CALLED IT.
ON A FEDERAL BUDGETING PROCESS.
>> I MEAN, YOU WILL ABSOLUTELY
HEAR IN HEARINGS MEMBERS AND SO
THERE'S PUBLIC WITNESSES
OPPORTUNITIES IN THESE HEARINGS
AS WELL AS THE AGENCY HEARINGS
THAT CERTAINLY SOMETHING THAT'S
ADDRESSED.
WE SORT OF ACKNOWLEDGE AND
REQUEST FUNDING TO COVER THE
COST OF INFLATION.
WE RARELY GET IT.
BUT TO THE EXTENT THE ACADEMIC
RESEARCH COMMUNITY CAN COME
TOGETHER AND MAKE THOSE POINTS
IN A ORGANIZED WAY IN A SORT OF
UNIFIED WAY, THAT'S VERY
HELPFUL.
MEMBERS AND IS SUBCOMMITTEE
STAFF WANT TO HEAR FROM
PROFESSIONAL GROUPS WHO CAN SAY,
HERE IS WHAT YOU MIGHT NOT
UNDERSTAND.
THEY'RE LOOKING AT WHAT WAS THE
SUCCESS RATE AND THE FUNDS THAT
GIVE US AND IN WAYS THAT WE CAN
SEE DELIVERABLES AND METRICS.
IT'S MEANINGFUL COMING FROM
RESEARCHERS THEMSELVES.
>> SEEING NO OTHER HANDS.
THANK YOU SO MUCH M.K.
NEXT WE HAVE SCIENTIFIC
PRESENTATIONS FROM JIM DOROSHOW.
JIM AS YOU KNOW IS THE NCI
DEPOSIT YOU TREE DIRECTOR AND
DIRECTOR OF DIVISION CANCER
TREATMENT AND DIAGNOSIS.
JIM, ALL YOURS.
>> THANK YOU, VERY MUCH, KEITH.
IT'S TIMELY GIVEN THAT IT'S JUST
THREE YEARS SINCE ALL OF US
STARTED TO CONFRONT THE ISSUE OF
THE PANDEMIC AND OUR CLINICAL
RESEARCH INFRASTRUCTURE TO
REVIEW SOME OF THE THINGS THAT
HAPPENED AND SOME OF OUR
RESPONSES TO THOSE THINGS.
AND HOW WE VIEW THE FUTURE.
NEXT SLIDE.
SO MY OVERVIEW REALLY IS TO TALK
ABOUT THE ON GOING EFFORTS TO
DEAL WITH THE EFFECTS OF THE
PANDEMIC ON CLINICAL CANCER
RESEARCH.
TO TALK A LITTLE BIT ABOUT OUR
2030 STRATEGIC VISION FOR
CLINICAL TRIALS AND THEN TO TALK
ABOUT AND HOPEFULLY TALK WITH
YOU ABOUT ACTIVITIES TO' MILL
RATE THE CURRENT CLINICAL
RESEARCH THAT ARE IMPACTING I
THINK ALL OF US.
WHAT ABOUT THE USE OF IMAGING
AND LABORATORY FACILITIES THAT
REQUIRED PATIENTS TO COME TO
ACADEMIC MEDICAL CENTERS AND TO
COLLECT DATA THAT MIGHT OR MIGHT
NOT BE OF GREAT IMPORTANCE FOR
THE TRIALS THAT WE CONDUCT.
WHAT ABOUT THE NEED TO COLLECT
LOW-GRADE ADVERSE EFFORTS
DESPITE THE LACK OF THE
RELEVANCE OF THOSE POTENTIAL
STUDY END POINTS AND IMPORTANTLY
ABOUT WHAT THE LIMITED ACCESS TO
PERSONNEL AND FACILITIES AND THE
REPROGRAMMING OF CLINICAL
RESEARCH RESOURCES FOR CARE THAT
ALL OCCURRED VERY RAPIDLY IN
FEBRUARY AND MARCH AND APRIL OF
2020.
SO WE'VE ALL DEALT WITH THAT AND
WE'LL TALK ABOUT HOW SOME OF THE
THINGS THAT WE'VE DONE TO TRY TO
DEAL WITH THOSE ISSUES.
I WANT TODAY EMPHASIZE THAT
THERE ARE REALLY ARE MAJOR ON
GOING ISSUES THAT EVEN THOUGH
SOME OF THE WORST ASPECTS OF THE
PANDEMIC HAVE BEEN CONFRONTED
AND DEALT WITH, THEY REMAIN
CRITICAL SHORTAGES OF RESEARCH
NURSES AND CRAs AND RESEARCH
STAFF IN REGULATORY OFFICE
THAT'S ARE ESSENTIAL.
ESSENTIAL HEALTHCARE WORKERS IN
RADIOLOGY AND PATHOLOGY AND THE
INFRASTRUCTURE AND IN TERMS OF
OUR IRBs AND CONTRACTING
OFFICES AND REALLY HAVE
AUTOMATIC -- THESE HAVE LED TO
DELAYS IN REPORTING SO TRIALS
MAKE IT OPENED BUT THE DATA ARE
NOT GETTING REPORTED IN A TIMELY
FASHION IN IS SOME CASES WHICH
LEADS TO A DECREASE IN THE
TIMELINESS THAT RESULTS GET
PUBLISHED.
ALL CREDIT GOES TO MY COLLEAGUES
WHO THREE YEARS AGO, WORKED VERY
QUICKLY FOR THE NCI CLINICAL
TRIALS PORTFOLIOS TO CHANGE TO
THE USE OF THE ELECTRONIC
CONSENTING AND TO PROVIDE ORAL
INVESTIGATIONAL AGENCY TO
PATIENTS AND TO INITIATE
ELECTRONIC RATHER THAN IN-PERSON
STUDY AUDITS.
TO FACILITATE TELEMEDICINE FOR
STUDY VISITS AND THEN TO TAKE
SPECIFIC ACTION TO LIMIT THE
ADVERSE IMPACT OF MINOR STUDY
DEVIATIONS ON TRIAL CONDUCT OR
THE EVALUATION OF THOSE TRIALS
AND DEGREE CENTRALIZED TESTING
AND ENERGY STUDIES AND AS I'LL
TALK ABOUT A LITTLE BIT, DURING
THAT THE MIDST OF THIS OR THE
WORST PART OF THE PANDE PANDEMIN
2020 AND 2021 WE HAD A NEW PLAN
FOR NCI CLINICAL TRIALS PROGRAMS
WHICH IS IN THE MIDST OF BEING
IMPLEMENTED.
HERE IS SOME DATA.
AND THIS IS UP-TO-DATE DATA
THROUGH THE END OF 2022 AND
EVERYBODY KNOWS BECAUSE I THINK
I'VE SHOWN THIS GROUP BEFORE,
WHAT I CALL THE GRAND CANYON IN
ACCRUAL, THESE REPE DOES NOT INE
THE INDUSTRIAL TRIALS AND IN
MARCH AND APRIL AND MAY JUNE
THERE WAS THIS 50% DECREASE IN
ACCRUAL TO NCTN.
CO-OPERATIVE GROUP TRIALS TO
INVESTIGATOR INITIALED TRIALS TO
PEER-REVIEWED GRANT FUNDED
TRIALS AND THE WHAT YOU CAN SEE
IN GRAY IS RAPIDLY AND HAPPILY
FOR US, THE NCTN ACCRUAL CAME
BACK TO WHERE IT WAS IN 2019.
AND HAS MAINTAINED A STEADY
STATE OVER THE LAST THREE YEARS
BUT WHAT I THINK IS EQUALLY
CLEAR IN ORANGE FOR PROSECUTE
REVIEW TRIALS OR IN BLUE FOR
INVESTIGATOR INITIATED TIMES,
THE CANCER CENTERS THAT REPORT
THIS INTO THE CTRP IT'S STILL
ABOUT 25% BELOW WHERE IT WAS
BEFORE THE PANDEMIC.
AND THIS IS I THINK A MAJOR
CONCERN BECAUSE MANY OF THE
INNOVATIVE STUDIES THAT
INVESTIGATORS PURSUE WHETHER
THEY'RE GRANT SUPPORTED IITs
HAVE NOT COME BACK AND OVER THE
LONG-TERM, AND THREE YEARS IS
LONG-TERM, TO HAVE AN ADVERSE I
AM IMPACT ON THE A LOT OF OUR
CLINICAL TRIALS SYSTEM TO DO
WHAT IT NEEDS TO DO.
IF YOU LOOK AT THE BARON THE
LEFT, YOU SEE WHERE WE WERE IN
2019 AND IN 2020 EVERY CATEGORY
OF TRIAL WHETHER IT'S PHARMA,
PEER-REVIEWED STUDY AND
INSTITUTIONAL TRIAL OR THE NCTN
TRIALS HAVE ALL DIMINISHED AND
THEY'VE DIMINISHED SIGNIFICANTLY
BUT IF YOU COMPARE 2020 TO 2022
AND YOU LOOK AT THE NUMBERS,
WHAT YOU SEE IS THE PHARMA
ACCRUAL IS BACK TO WHERE IT WAS
PRE-PANDEMIC AND NONE OF THE
OTHER CATEGORIES SAFE FOR NCTN
SO SPECIFICALLY PEER REVIEW
TRIALS, GRANT FUNDED TRIALS AND
IMPORTANTLY INSTITUTIONAL IITs
ARE FAR PEL OWE WHERE THEY WERE
PRE-PANDEMIC AND IF YOU LOOK AT
THE LIGHT BLUE, WE'RE TALKING
ABOUT A DROP FROM 19,000
PATIENTS IN 2019 TO 14,000
PATIENTS ON IITs IN 2022 AND
I'M SURE THE MEMBERS OF THE BSA
WHO WORK IN CLINICAL TRIALS AT
THEIR CANCER CENTERS ARE WELL
AWARE OF THIS ISSUE.
WE WANTED TO FIND OUT EXACTLY
WHAT WAS IND LYING THIS AND I'M
SURE NONE OF THE DATA THAT I'M
GOING TO SHOW SUE GOING TO BE
NEW TO MOST OF YOU.
BUT WE DID A SURVEY THAT
REMARKABLY GOT A RESPONSE FROM
100% OF THE CANCER CENTERS THAT
DO CLINICAL TRIALS.
I WANTED TO UNDERSTAND THE
IMPACT OF COVID ON THE CURRENT
CLINICAL TRIAL CAPACITY AND I
THINK THE POINTS TO BE RAISED
ARE SHOWN IN BLUE.
REALLY, THE MAJOR IMPACT THAT
WAS FELT WAS THAT TRIALS WERE
NOT OPEN AS RAPIDLY AS ONE HAD
HOPED AND THERE WAS BECAUSE OF
THE LIMITED CAPACITY OF THE
RESEARCH STAFF, THE ACCRUAL
TRIALS WERE PUT ON HOLD IN TERMS
OF ACCRUAL AND THE ACCRUAL
NUMBERS DECREASED AS I SHOWED.
SO WHY?
WELL, BECAUSE WE LOST A
TREMENDOUS PERCENTAGE OF OUR
CLINICAL RESEARCH STAFF.
AND WHERE DID THEY GO?
THEY WENT BASICALLY TO CROs
AND PHARMA BECAUSE THOSE
ENTITIES WERE ABLE TO PAY
SUBSTANTIALLY HIGHER AMOUNTS OF
SALARY MONEY AND PROVIDED
GREATER FLEXIBILITY AT LEAST
INITIALLY IN TERMS OF THE
ABILITY TO WORK REMOTELY.
AND THIS IS HAD A MAJOR IMPACT,
NEXT SLIDE.
AND YOU CAN SEE THAT THIS, WE'RE
TALKING ABOUT HALF OF OUR LOSS
WAS TO PHARMA AND CROs AND
THIS ADVERSE IMPACT IS SUCH THAT
THE VAST MAJORITY OF THE NCI DES
EGG NATURED CANCER CENTERS IN
ONE WAY OR ANOTHER HAVE HAD A
DIFFICULT TIME IN MAINTAINING
THEIR CLINICAL TRIALS ACCRUAL
OVER THE LAST THREE YEARS.
NEXT SLIDE.
WHEN PEOPLE PROVIDE INPUT IN
TERMS OF THE LOSSES THEY
EXPERIENCE AND THE LOSSES BOTH
IN THE REALM OF SENIORS STAFF AS
WELL AS RECENT TRAINEES, WHICH
MEANS THAT THE ENTIRE POOL OF
QUALIFIED CA CANDIDATES WERE SUD
UP INTO A DIFFERENT SYSTEM TO DO
CLINICAL TRIALS AND THIS HAS HAD
AN ADVERSE IMPACT IN THE ABILITY
OF MANY CANCER CENTERS TO
MAINTAIN THE PACE AND THE
VIABILITY OFFER A PROLONGED
PERIOD OF TIME.
SO, RIGHT IN THE MIDST OF THIS,
WE BEGAN WORKING ON A NEW VISION
FOR OUR CLINICAL TRIALS
PROGRAMS.
I'D LIKE TO SHARE SOME OF THE
MAJOR AREAS THAT WERE
RECOMMENDED FOR CHANGE AND SOME
OF THE THINGS THAT WE'VE I AM
IMPLEMENTED.THIS IS APP ON GOIN,
NEXT SLIDE.
WHAT WERE THE MAJOR THEMES.
WHAT INFRASTRUCTURES WERE
CRITICAL?
AND THE MAJOR THEMES WERE TRIAL
COMPLEXITY AND COST, NO
SURPRISE, HOW DO WE DEAL WITH
DECENTRALIZED TRIAL ACTIVITIES
WHILE AT THE SAME TIME PROMOTING
ACCRUAL AND ACCESS.
CAN WE DEVELOP NEW DATA
COLLECTION APPROACHES AND HOW DO
WE COLLECT PRO DATA IN THIS
ENVIRONMENT?
AND SPECIFICSLY, HOW DO WE DEAL
WITH THE OPERATIONAL BURDEN SO
THERE WERE SOME STATISTIC ISSUES
AND AT END OF THE THIS ISSUE OF
WORKFORCE THAT IS CRITICALLY
IMPORTANT.
NEXT SLIDE.
IF WE TAKE THE 30,000-FOOT VIEW
OF THIS ENTIRE PROCESS, OUR GOAL
AND THIS IS A MULTI AND ALREADY
AND TRY TO DEVELOP MORE
FLEXIBILITY, FASTER, SIMPLER,
LESS EXPENSIVE TRIALS THAT
INTEGRATE WITH CLINICAL
PRACTICES AND WE MUST STREAMLINE
FOR TRIAL DESIGN AND EXECUTION
AND FOCUS ON -- I'LL TALK ABOUT
THIS MORE, ON THE MOST ESSENTIAL
END POINTS.
DECREASE REGULATORY BURDENS AND
INCREASE THE EFFICIENCY OF OUR
DATA COLLECTION.
SO I'M GOING TO TALK A LITTLE
BIT ABOUT STREAMLINING CLINICAL
TRIALS BECAUSE WE'VE REALLY MADE
SOME PROGRESS IN THIS AREA AND I
THINK IT'S GOING TO HAVE A
SIGNIFICANT IMPACT IN EVERYTHING
THAT WE DO IN TERMS OF THE NCI
SUPPORT CLINICAL TRIALS AND THE
FIRST AREA I'M GOING TO TALK
ABOUT IS LIMITING THE DATA
ELEMENTS THAT WE COLLECT.
YOU ALL KNOW THAT FOR EVERY
PIECE OF DATA YOU COLLECT, EVERY
DATA ELEMENT COST MONEY.
AND WE HAVE TO -- THE QUESTION
IS, DO WE NEED TO COLLECT
EVERYTHING THAT WE'RE CURRENTLY
COLLECTING, ESPECIALLY IN OUR
LATE PHASE PORTFOLIO OF TRIALS.
AND SO TO ANALYZE WHAT WE'RE
DOING, WE PUT TOGETHER AN EXPERT
WORKING GROUP AND ANALYZED A
LARGE SERIES OF ON GOING PHASE 3
TREATMENT PROTOCOLS TO
UNDERSTAND WHAT WE WERE
COLLECTING AND JUST HOW
IMPORTANT WERE THE DATA THAT --
AND NOW DID IT IMPACT THE OUT
PUTS FOR THESE TRIALS.
AND I'M ALSO GOING TO TALK ABOUT
THE REALLY DIFFICULT ISSUES OF
GETTING THE TREATMENT REGIMENTS
INTO OUR EHRs A PROBLEM THAT
DIDN'T EXIST 10 YEARS AGO THAT
THAT'S MADE A MAJOR IMPACT IS
COSTLY AND IT'S SOMETHING THAT'S
NOT GOTTEN A LOT OF REVIEW AND I
THINK I'M GOING TO HELP TO SHOW
YOU THAT WE'RE TRYING TO MAKE
SOME IMPACT IN DEALING WITH THIS
REALLY IMPORTANT PROBLEM AND IT
SLOWS DOWN THE ENTIRE PROCESS
AND IT'S VERY COSTLY.
NEXT SLIDE.
SO WHAT ARE THE LOW DATA VALUE
ELEMENTS THAT ARE EXPERT GROUP
CAME UP WITH.
WHAT IS THE SCOPE OF THE
RECOMMENDATION THAT'S THEY CAME
UP WITH SO THE FIRST WE GET IS
TO TRY TO UNDERSTAND WHERE COULD
WE FOCUS ON CHANGING THE
STANDARD OF PRACTICE.
WHAT DID WE HAVE CONTROL OVER
THAT COULD BE RESULTED IN
CHANGES THAT WE COULD MANAGE IN
A RELATIVELY RAPID TIMEFRAME.
SO WE FOCUSED INITIALLY ON
EVALUATING CTEP MANAGED TRIALS,
LATE-PHASE TRIALS, TREATMENT
TRIALS AND ADULT TRIALS AND IND
EXEMPT TRIALS.
IT DOESN'T MEAN THAT WE'RE NOT
INTERESTED IN PEDIATRIC TRIALS
OR PREVENTION TRIALS OR OTHER
KINDS OF THINGS BUT THESE THINGS
BECAUSE THEY'RE IND EXEMPT, AND
HAVE OUR MAKE UP A MAJOR PORTION
OF THE PORTFOLIO OF NCTN TRIALS,
WE COULD CHANGE WITHOUT GETTING
MAKING MAJOR REGULATORY HAVING
REGULATORY HURDLES.
NEXT SLIDE.
SO WHAT ARE THE CATEGORIES THAT
WE'RE EVALUATING?
THESE ARE THE THINGS IF YOU
REALLY TALK TO FOLKS WHO ARE IN
THE DAY-TO-DAY BUSINESS OF
RUNNING CLINICAL TRIALS, EVERY
ONE OF THESE CATEGORIES, WE
COULD SPEND HOURS ON THE
COMPLAINTS THAT PEOPLE HAVE
ABOUT THE EXCESS AMOUNT OF DATA
THAT WE COLLECT IN EVERY ONE OF
THESE AREAS AND I'M GOING TO
SHOW YOU SOME OF THE THINGS WE
THINK CAN BE CHANGED THAT WILL
STREAMLINE THE PROCESS OF OUR
LATE PHASE CLINICAL TRIALS
PROGRAMS.
NEXT SLIDE.
I WOULD SAY ON THE TOP OF THE
LIST OF PET PEEVES THAT CLINICAL
INVESTIGATORS HAVE IS WHY WE
SHOULD CONTINUE TO COLLECT FOR
WELL ESTABLISHED DRUGS THAT HAVE
TOXICITY PROFILES THAT ARE
WELL-KNOWN, WHY SHOULD WE
COLLECT LOW-GRADE ADVERSE EVENTS
AND PROBABLY WORSE, WHY SHOULD
WE TRY TO UNDERSTAND THE
ATTRIBUTION, AND WORSE OF ALL,
THEIR START DATE AND STOP DATES.
WE HAVE CRAs SPENDING HOURS
AND SHOWERS TRYING TO ASSESS
FROM THE MEDICAL RECORD THOSE
DATA ARE ESSENTIALLY NEVER USED
WHEN THE PUBLICATION COMES OUT.
WE THOUGHT FOUGHT CLEARLY ABOUT
ALL THE EXCESS LABORATORY DATA
THAT'S COLLECTED AND ESPECIALLY
LABORATORY THAT'S COLLECTED
BEYOND STANDARD OF CARE AND IT'S
UNRELATE TO STUDY ENTER POINTS
OR SAFETY MONITORING.
I'VE HAD PERSONAL EXPERIENCE
WHEN I WAS ON ODAC OF PEOPLE
WANTING TO KNOW WHAT MIGHT THE
HEMOGLOBIN BE ON DATE 8 OF CYCLE
14 OF SOME REGIMENT THAT HAD
NOTHING TO DO WITH THE OUTCOME
OF THE TRIAL.
WE COLLECT ALL THAT DATA.
WE DON'T USE THAT DATA.
AND THIS MEANS THAT THERE ARE UP
USED COMPONENTS IN LABORATORY
PANELS THAT GET PUT INTO CASE
REPORT FORMS AND THAT ARE
ABSOLUTELY UNNECESSARY AND TAKE
TIME AND NEVER HAVE SIGNIFICANT
IMPACT ON THE OVER ALL OUTCOME
OF THE TRIAL AND THE SAME CAN BE
SAID CHAPTER AND VERSE FOR
IMAGING THAT IS DONE BEYOND THE
STANDARD OF CARE.
NEXT SLIDE.
REMARKABLY, THERE ARE MANY
THINGS ABOUT HISTORY AND
PHYSICAL EXAMINATION.
THEY'RE NEVER USED.
WE COLLECT ENORMOUS AMOUNTS OF
DATA ON MEDICATION THAT'S ARE
COMPLETELY IRRELEVANT TO
PROTOCOLS.
WE COLLECT EVEN MORE DATA WHEN
THOSE CON COM TANT ARE STARTED
AND DIS CONTINUED THAT HAVE
NORTH TO DO WITH SAFETY.
THEY WILL BE FOCUSED ON
LATE-STAGE TRIALS, IND EXEMPT
TRIALS TO REDUCE THE OPERATIONAL
BURDEN OF THOSE TRIALS AND THEN
TO PROVIDE INSIGHTS THAT WILL
INFORM US IN TERMS OF WHAT IS
ACTUALLY NEEDED, WHAT DATA ARE
NEEDED TO BE COLLECTED, FOR A
LATE-PHASE IND RELATED TRIALS
AND PEDIATRIC TRIALS AND WE ARE
IN THE PROCESS OF TRYING TO
DEVELOP A BROAD STAKEHOLDER
ENGAGEMENT IN INPUT AND HOW TO
SUCCESSFULLY IMPLEMENT CHANGES
THAT WILL BE EMBRACED ACROSS THE
COMMUNITY AND REQUIRING US TO
COLLECT MUCH LESS DATA AND
HOPEFULLY WILL ALLOW US TO USE
OUR PERSONAL MUCH MORE
EFFECTIVELY.
NEXT SLIDE.
THIS IS NOT JUST A FANTASY.
THIS IS THE SCHEME FOR THE
PRAGMATIC TRIAL.
I WANT TO SAY TWO THINGS ABOUT
THIS STUDY.
WE STARTED TALKING ABOUT THIS
TRIAL LATE IN AUGUST.
OF 2022.
THE FIRST PATIENT WAS ENTERED ON
PRAG PRAGMATIC LAST WEEK.
SIX AND A HALF MONTHS FROM START
TO FINISH FOR A RANDOMIZED TRIAL
THAT WILL LEAD TO AN INDICATION
PROVED BY THE FDA AND A SURVIVAL
OUTCOME ONLY, NO PFS, WITH
MINIMAL IMAGING AND MINIMAL
LABORATORY COLLECTION, AND NO
ADVERSE EVENTS COLLECTED EXCEPT
FOR HOSPITALIZATIONS THAT HAS A
SCHEME A PAGE THAT IS SMALLER
THAN ANYONE WHO HAS WRITTEN A
CLIP CAL CLINICAL TRIALS BECAUSS
DATA BECAUSE WE'RE LOOKING FOR
WHETHER OR NOT THIS TRIAL, WHICH
IS AN EXPANSION OF A TRIAL THAT
WAS INITIALLY A SMALL RANDOMIZED
PHASE 2 STUDY IN LONG MAP, NOW
EXPANDED TO ABOUT 700 PATIENTS
WILL ACTUALLY REACH THE MOST
IMPORTANT END POINT THAT IS
THERE A COMBINATION OF A
INHIBITOR AND A CHECKPOINT
INHIBITOR WILL CHANGE THE
SURVIVAL IN THIRD LINE NON SMALL
LUNG CANCER TREATMENT.
THAT'S IT.
THAT'S THE QUESTION.
EITHER WILL OR IT WON'T.
IF IT DOES, IT'S LIKELY TO GET
APPROVED SPECIFICALLY BY THE FDA
AND WITH THE FULL CONCEPT OF
AMERICAMERCKAND LILLY.
IT'S POSSIBLE TO WRITE TRIALS
THAT REQUIRE MINIMAL DATA THAT
COULD ACTUALLY LEAD TO AN
IMPORTANT CHANGE IN THE STANDARD
OF CARE.
SO I'D LIKE TO SAY A WORD TO EHR
BILLS SO THIS IS NOT SOMETHING
THAT GETS A LOT OF PUBLICITY AND
YET IT IS THE BAIN OF THE
EXISTENCE OF EVERY CLINICAL
TRIALS OFFICE IN EVERY NCI
DESIGNATED CANCER CENTER.
SO WHAT DOES THIS MEAN?
IT MEANS THAT FOR THOSE WHO
REPEAT FAMILIAR WITH THIS, EVERY
TIME YOU HAVE A CLINICAL TRIAL,
IT REQUIRES THAT THE ORDERS FOR
THE THE TREATMENT AND ALL THE
LABORATORY STUDIES THAT WILL BE
PERFORMED IN ALL THE STUDY
VISITS GET PROGRAMMED INTO THE
EHR RECORD SO WHY IS THAT A
PROBLEM?
WELL THE PROBLEM IS EVERY
HOSPITAL THAT'S A DIFFERENT DRUG
FORMULARY AND EVERY HOST AND
CANCER CENTER HAS VARIETIES THAT
MAY BE MODEST AND THEY'RE STILL
DIFFERENT IN TERMS OF THE
CLINICAL PRACTICE GUIDELINES
THAT ARE USED FOR HOW DRUGS ARE
PUT INTO VARIOUS KINDS OF
INTERVENE US SOLUTIONS SO, IT
MAY BE THAT AT THE DANA FARBER
IS ONLY GIVEN IN SALINE AND IF
THE CITY OF HOPE IT MAY BE GIVEN
IN HALF NORMAL SALINE AND SOME
PLACE ELSE IT MAY BE 50CCs AND
SOME PLACE IT'S A LITER.
EVERY SINGLE TIME THAT DRUG IS
USED IN ANY PROTOCOL IT HAS TO
BE DONE IN SUCH A WAY THAT IS
CONSISTENT WITH THE INDIVIDUAL
PRACTICE IN THAT HOSPITAL.
SO THE ENORMOUS VARIATION ACROSS
PROTOCOLS, AND IN TERMS OF WHAT
IS IN THE PROTOCOL, AND WHAT IS
NOT IN THE PROTOCOL AND HOW THAT
GETS PUT INTO THE INDIVIDUAL
INSTITUTIONS EHR IS ENORMOUS AND
IT IS BEEN ESTIMATED THAT IT
TAKES OVER 24 HOURS TO BUILD A
TREATMENT PLANT FOR A SINGLE
STUDY ARM IN EPIC SO LET ME JUST
DO THE MATH, FOR NCI MATCH, 39
ARMS, ACROSS OVER 1800 SITES
TIMES 26 HOURS AND IT'S
UNBELIEVABLE AND THIS AMOUNT OF
WORK AND LITERALLY BILLIONS OF
DOLLARS TO BE ABLE TO PUT THE
INFORMATION THAT YOU NEED TO
CARRY OUT IN THE ELECTRONIC
HEALTH RECORD AND THE LOGO
RESOURCES ARE NEVER FULLY
REIMBURSE AND SO THIS IS A HUGE
PROBLEM AND WE'RE HOPING TO DO
AT LEAST MAKE SOME DENT IN.
SO, OUR GOAL IS TO TRY TO
FACILITATE STANDARDIZED AND
ACROSS CLINICAL TRIALS AND ABOUT
A YEAR AND A HALF AND WE FUNDED
TWO CONSORTIA AND CENTER TO
CENTER TO CENTER.
WE ARE IN THE PROCESS.
PACKAGE THESE IN FORMS THAT CAN
BE IMPORTED DIRECTLY INTO A SITE
CHR OR WILL FACILITATE LOGO
CUSTOMIZATION AND TO BASICALLY
ECONOMIZE THIS EFFORT BECAUSE
NOTHING COULD BE BETTER AND IF
WE CAN HARM ON EYES THOSE THINGS
IT WOULD SAVE MONTHS OF TIME TO
ACTIVATE PROTOCOLS SITE AFTER
SITE IT WOULD BE A WONDERFUL IF
WE CAN FORMALIZE AND A LOT
EASIER AND OPERATIONALIZE THEIR
ACTIVATION OF THEIR TRIALS AND
SAVE ENORMOUS AMOUNT OF MONEY.
NEXT SLIDE.
THE LAST THING I WOULD LIKE TO
COME BACK TO, I SAID I WANTED TO
ADDRESS SOME OF THESE ISSUES
RELATED TO WORKFORCE.
BECAUSE THIS IS A BIG DEAL.
FROM CENTER TO CENTER AND SOME
PLACES HAVE DEALT WITH IT BETTER
THAN OTHERS AND THERE ARE SITES
THAT LITERALLY OVER THE LAST
THREE YEARS HAVE LOST 60% OF
THEIR ENTIRE CLINICAL TRIALS
WORKFORCE AND THEY'VE HAD TO
REPLACE THOSE INDIVIDUALS THE
NCI CAN HELP STREAMLINE THE
PROCESS FOR TRIAL ACTIVATION AND
MOST IMPORTANTLY REDUCE THE
VOLUME OF WORK THAT'S REQUIRED
TRIAL BY TRIAL AND TRY TO
INCREASE THE FLEXIBILITY OF
DOING THESE THINGS TO MAKE IT
EASIER FOR CENTERS TO OPEN OUR
TRIALS.
SOME OF THE THINGS THAT I'VE
TALKED ABOUT BEFORE THAT WIRE
WORKING ON.
IT'S WHETHER WE CAN CONSIDER
DEVELOPING A TRAINING PROGRAM,
TO TRY TO FOCUS THE DEVELOPMENT
AND FACILITATE THE HIRING AND
TRAINING OF INDIVIDUALS WHO MANY
ARE IN POSTBAC PROGRAMS THAT
WANT TO USE TRAINING AS A CRA,
AS A STEPPING STONE OR WANT THIS
AS A LONG-TERM CAREER AND WE
FACILITATE DEVELOPING THOSE
PROGRAMS AT CANCER CENTERS TO
FIND THE PUMP SO WE HAVE A
LONGER TERM SOLUTION TO FINDING
THE PERSONNEL IT REQUIRES.
LASTLY, I HOPE TO HAVE IF ABOUT
SIX MONTHS HAVE ENOUGH
EXPERIENCE IN THIS WHAT I CALL A
VIRTUAL CLINICAL TRIALS OFFICE
PILOT STUDY WE STARTED IN THE
LAST FEW MONTHS AND TO TRY TO
BRING BACK TO YOU, INTO THE
METADATA RAVE SYSTEM TO TAKE
THIS BURDEN OFF SITE SO THEY CAN
ACTUALLY ACCRUE THEIR STUDIES
AND OPEN THEIR TRIALS AND DO IT
IN A MORE TIME EFFICIENT MANNER
AND REALLY CONTINUE THE PROCESS
OF OUR TRANSLATIONAL STUDIES IN
A MORE EFFICIENT WAY.
I'M HAPPY TO STOP HERE AND TAKE
AS MANY QUESTIONS AS WE HAVE
TIME FOR.
>> THANK YOU, ANYMORE.
IT'S QUITE AN INSPIRED
INITIATIVE.
I WILL JUST SAY AS A COMMENT,
I'LL SAVE QUESTIONS FOR MABEL
OFF LINE COMMUNICATIONS BUT
REALLY FABULOUS.
I THINK RAY, YOU MIGHT HAVE BEEN
FIRST.
>> YEAH, THANK YOU, KEITH.
SO, JIM, I HAVE TO CONGRATULATE
YOU FOR KEEPING THE FING FINGERF
THE PULSE.
I'M BLOWN AWAY HOW COMPREHENSIVE
AND HO DEEP YOUR KNOWLEDGE FROM
THE STANDARD EVIDENCE WHAT LIFE
IS LIKE ON THE STREETS AND THE
MINORITY UNDER SURVEY IN A HUGE
COMMUNITY HEALTH-CARE SYSTEM
ACROSS THE MISSISSIPPI DELTA AND
THAT HAD NO PRIOR RESEARCH
ACTIVITY AND YOU KNOW, A LOT OF
WHAT YOU HAVE RAISED ARE VERY
GERMANE AND SO A FEW THINGS I
JUST WANT TO REINFORCE, ONE IS
THIS COMPLEXITY OF INANE REQUEST
THAT JUST CLEARLY ARE NOT
RELEVANT TO THE WORK AT HAND
THAT TAKE ON A LIFE OF THEIR OWN
AND OCCUPY A LOT OF HUMAN
RESOURCE AND I THINK IT'S VERY
MUCH WORTHY OF IT'S LOOKING
CRITICALLY UNLESS IT'S REALLY
REDUNDANT THE THINGS THAT WE DO
AND QUESTION I DO HAVE, JIM, IS
THE END CORE RELAXATION ITEMS
THAT CAME OUT OF THE VANCOUVER
PANDEMIC, WE KEEP ASKING, WILL
THEY BE MADE PERMANENT.
WE DON'T WANT TO GO BACK TO A
WORLD IN WHICH THINGS THAT
TECHNOLOGY WILL ENABLE US TO DO
MORE EFFICIENTLY AND WE HAVE TO
DO MANUALLY SO DO YOU HAVE DO
YOU HAVE A WORD OF THAT?
>> WE'RE NOT GOING TO STOP
SENDING ORAL DRUGS OUT TO SITES.
PEOPLE ARE NOT GOING TO HAVE TO
DRIVE 100 MILES ON PILLS AND
WE'RE NOT GOING TO GO BACK TO WE
REALLY -- I HOPE THAT THE
RELAXATION IN TERMS OF BEING
DINGED FOR GRADE 1 APPROXIMATE
AEs THAT ARE USE LESS IN YOUR
AUDITS IT MUST STOP, RIGHT.
IT'S GOT TO BE THE COMMUNITY HAS
TO AGREE THAT WE'RE GOING TO
STOP THAT AND THE OUTCOME OF OUR
TRIALS WILL BE JUST FINE WITHOUT
THAT.
I'VE BEEN ASKED ABOUT IMPORTANT
ISSUES THAT I THINK YOU WOULD
AGREE WITH.
THERE ARE SOME THINGS THAT ARE
LOW GRADE BUT CHRONIC TALKS SIS
TEE.
ESPECIALLY IF THEY'RE NOT KNOWN.
WE CAN'T GIVE UP.
SO IF SOMEONE HAS GRADE 2
DIARRHEA FOR FOUR MONTHS, YOU
PROBABLY WANT TO KNOW THAT,
RIGHT.
YOU DON'T WANT TO KNOW IF
SOMEONE HAS A HEMOGLOBIN OF 9.9
ON CYCLE FOUR OF WHATEVER.
THAT'S USE LESS INFORMATION
THAT'S NEVER GOING TO HAVE AN
IMPACT ON YOUR PRACTICE, RIGHT.
AND THE REAL WORLD.
SO, MY VIEW IS THAT WE HAVE TO
MAKE -- AND THIS SOUNDS SO
BUREAUCRATIC YOU WILL JUST
LAUGH, RIGHT.
IT TURNS OUT, THAT WHAT IS THE
ISSUE WITH TELEHEALTH.
WE NEED TO LEARN HOW TO DO
TELEHEALTH, TELEMEDICINE IN OUR
TRIALS BETTER, OKAY.
BUT IN TERMS OF IT BEING
SOMETHING THAT IS ACCEPTABLE, IT
NEEDS TO BE TELEHEALTH AND WE
WEREN'T WRITING THOSE INTO
PROTOCOLS.
THIS IS BASICALLY ADMINISTRATIVE
GOOK THAT CAN BE CHANGED VERY
EASILY, RIGHT, AND SO TO ME THE
NEXT STEP IS WE DID ALL THESE
THINGS, WHAT IS THE NEXT WHOLE
RANGE OF THINGS THAT WE DON'T
HAVE TO DO?
NOW I'M NOT -- YOU KNOW, I'M A
PHASE 1 INVESTIGATOR, WE DON'T
NEED TO VERY CAREFULLY, VERY
CAREFULLY COLLECT INFORMATION ON
TOXICITY AND EARLY PHASE TRIALS
AND I DON'T MEAN TO IMPLY THAT
AT ALL BUT HOW MANY TIMES DO WE
HAVE TO RECOLLECT DATA ON
PATIENTS GETTING A PEM BROW,
RIGHT.
WE DON'T.
THIS MAKES A DIFFERENCE BECAUSE
I REALLY, IF YOU THINK ABOUT
WHAT CROs DO, AND THEY WANT TO
COLLECT THIS AND I DON'T MEAN T.
THEY GET PAID FOR EVERY DATA
ELEMENT SO THE MORE THINGS THAT
WE COLLECT, THE MORE THEY GET
PAID.
SO I THINK WE WILL RUN INTO THE
LESS WE DO AND IF WE CAN HAVE
OUTCOMES THAT SHOW WE GET THE
ANSWERS TO THE QUESTIONS WE'RE
INTERESTED IN, THEN WE'LL BE
PUSH BACK FROM PHARMA.
RIGHT.
BUT THAT'S THE BLESSING OF
HAVING THE NCI CLINICAL TRIALS
PROGRAM, ESPECIALLY TO DO IF WE
FOCUS INITIALLY ON NON IND
STUDIES IS WE CAN MAKE THESE
CHANGES.
AND SEE WHAT THE OUTCOMES ARE
GOING TO BE.
>> WE'RE GOING TO BE PRESSED FOR
TIME.
OTIS --
>> FIRST, I JUST WANT TO SAY
THANK YOU JIM.
YOU JUST DON'T KNOW HOW THRILLED
I AM TO KNOW THAT SOMEONE FROM
THE GOVERNMENT UNDERSTANDS ME
AND MY PROBLEMS.
THE ONE THING THAT I WOULD ADD,
DID THE CHARACTER IN NATURE OF
OUR CLINICAL TRIALS CHANGE OVER
THE LAST 10 YEARS AS WE WEPT TO
PRECISION, MEDICINE AND IMMUNO
THERAPIES AND OTHER THINGS AND
DID THAT CONTRIBUTE TO THE
DECLINE IN ENROLLMENT AS WELL?
AT OUR INSTITUTION, ENROLLMENT
STARTED DECLINING AND COVID JUST
ACCELERATED THINGS EVEN FURTHER
AND I'M WONDERING IF THAT'S PART
OF THE REASON FOR THE DECLINE
IT'S LIKE DECK CRATING CHRISTMAS
TREES AND THEY'RE PRETTY BUT
THEY DON'T REALLY CONTRIBUTE TO
THE QUESTIONS THAT WE WANT TO
ANSWER.
AND THAT'S WHAT WE HAVE TO THINK
ABOUT SERIOUSLY.
>> THANK YOU SO MUCH.
I MEAN, THIS IS LIKE THE
SOLUTION FOR THE FUTURE FOR
WORKFORCE ACROSS THE COUNTRY AND
WITH NEW FORMS OF AI, WE MAY
HAVE EVEN MORE POTENTIAL THERE.
I WANTED TO ASK YOU, I HEARD
CHALLENGES AND BIG PLAYERS IN
SOFTWARE FIELD WHETHER IT'S EPIC
OR ENCORE BEING COMPATIBLE SHALL
WE SAY.
WHAT CAN WE DO TO MOVE FORWARD
OR WHAT'S YOUR APPROACH TO THIS?
ARE YOU PLANNING TO START WITH
SOME PLAYERS FIRST AND SEE WHAT
WE CAN DO?
>> SO THAT CONSORTIUM WORKING
THERE'S ABOUT 10 NCI CANCER
CENTERS WORKING ON THESE THINGS
AND EPIC IS INVOLVED WHEN
SENATORS INVOLVED MORE SO EPIC.
BUT I THINK THE PROBLEM IS -- I
HAD NO IDEA BECAUSE YOU KNOW, WE
HAVE A COMPLETELY HOMEGROWN
CLINICAL TRIALS MAPPINGMENT MANT
SYSTEM AND IT'S UNLIKE ANYTHING
ELSE OUT THERE AND I HAD NO IDEA
THAT TO PUT 80 POTENTIAL DATA
ELEMENTS TO ENTER ONE ORDER OF
SIS PLATINUM, 80 DIFFERENT
FIELDS THAT MIGHT CONCEIVABLY --
SO WE JUST HAVE TO FIGURE OUT A
WAY AND ACTUALLY THE QUESTION
CAME UP EARLIER AND I LIKE TO
ADDRESS THAT AND YOU KNOW, IF WE
WROTE PROTOCOLS WE DIDN'T WRITE
THEM IN ENGLISH.
WE WROTE THEM IN A FORMAT THAT
BASICALLY JUST WROTE SCHEME A
PAGES AND THEY COULD BE
DIGITIZED IT WOULD MAKE THE
ENTIRE PROCESS MUCH, MUCH
SIMPLER.
BUT I MEAN, YOU KNOW, IT'S JUST
NOT WHAT PEOPLE HAVE DONE FOR 60
YEARS.
THAT'S WHAT NEEDS TO BE DONE
BECAUSE THEN YOU WOULD START
FROM A -- EVERYONE WOULD START
WITH A TEMPLATE THEY COULD MUCH
MORE RAPIDLY ADAPT TO THEIR.
>> PAULETTE IS STARING AT ME IN
THE SCREEN AND BOB.
>> THE IMPLEMENTATION AND ONE
THING IS COMMENT AND THE
CHAINING FOR THE WORKFORCE AND
AND I WOULD JUST ADD ONE AND
THINK ABOUT IN THAT AND RESEARCH
BASIS AND IN THE COMMUNITY
ALTHOUGH THERE'S A SIGNIFICANT
OVERLAP BETWEEN THOSE THAT MAYBE
WORK IN A CTO AND THERE'S ALSO A
LOT THAT IS REALLY DIFFERENT AND
MAKING SURE THAT THOSE ENTITIES
COULD ALSO TAKE ADVANTAGE OF ANY
KIND OF TRAINING GRADE OR
TRAINING OPPORTUNITIES TO CREATE
THOSE TO GENERATE THAT WORKFORCE
AS WELL AND THEN MY QUESTION TO
YOU IS WHEN WE THINK ABOUT
SIMPLIFYING AND I COULDN'T AGREE
WITH YOU MORE AND FOR US, WITH I
THINK ABOUT THE RESEARCH BASE
THAT I WORK IN AND HAVING A
INVESTIGATOR PUT OUT A STUDY
THAT IS AGREED UPON AND BY
PIPELINE FOR TREATMENT GRANT AND
THEY HAVE TO GO BEFORE A
STEERING COMMITTEE FOR A PEER RW
AND MANY ARE RO1 THAT IS
PEER-REVIEWED SO IF APPROXIMATE
YOU WANT THESE COULD BE
SIMPLIFIED AND WHAT IS THE PLAN
TO EDUCATE ALL THE DIFFERENT
BODIES OF PEOPLE WHO ARE
REVIEWING THE GRANTS BECAUSE
THAT'S WHERE THEY END UP BECOME
SEWING SOPHISTICATED THAT
THEY'RE IMPOSSIBLE TO DO.
SO WRITE IN BLACK WHITE NEW
SOPs FOR WHAT IS -- AT LEAST I
CAN'T TELL PHARMA WHAT TO DO.
BUT WE CAN PUBLISH WHAT THE
SOPs ARE FOR NCI TRIALS.
WE CAN GET -- IF WE CAN BUY IN
FROM THE NCTN GROUPS AND IT WILL
CHANGE.
IT WILL TAKE TIME.
NEW STUDIES CAN BE DEVELOPED
SAYING WELL, WE DON'T DO IT THIS
WAY ANYMORE.
THIS IS WHAT THE ENTIRE SYSTEM
AS AGREED TO CHANGE AND IT WILL
OVER TIME IT WILL CHANGE.
>> YOU COULD WRITE THAT IN AN
SOP BUT IF I HAVE AN
INVESTIGATOR WHO IS GOING AFTER
AFTER RO1 IN A REVIEW PANEL IT'S
SAYING, WE KNOW YOU ARE ONLY PUT
YOUR MEASURE THESE TWO OUTCOMES
BUT WE WANT THESE FIVE
COMPOUNDERS ALSO ADDED INTO THAT
TRIAL IT'S A PEER REVIEW LONG
BEFORE IT GETS TO OVER ALL
DEVELOPMENT SO HOW CAN WE TAKE
CARE OF THAT?
>> MAYBE WE CHALLENGE THE USE OF
CLINICAL PROGRESS NOTES FOR DATA
COLLECTION AND LET'S JUST TAKE
IT ALL ON.
I JUST WANTED SAY QUICKLY, AMONG
THE STAKEHOLDERS, WE RECOGNIZE
WE ARE OWN OUR WORSEN MO ENEMY.
WE HAVE NEED DEEPER
CONVERSATIONS WITH PHARMA AND
CONTRACT RESEARCH ORGANIZATIONS.
AND I'VE BEEN PART OF A LOT OF
PANELS AND I NEVER SEE A CRO
REPRESENTED.
I DON'T KNOW WHAT CAN NCI DO TO
ENGAGE THE CROs SO THAT WE FIX
THIS, NOT JUST NCI TRIALS BUT
EVERYTHING?
>> MY TWO CENTS IS THAT YOU
KNOW, PHARMA RELUCTANT BECAUSE
THEY HAVE -- THEY HAVE
PERCEPTIONS OF WHAT THE FDA
REQUIRES.
AND SO AS Dr. BERTAGNOLLI
SAID, DOING THINGS THAT ARE DONE
IN CONCERT WITH THE FDA WHERE IT
IS VERY CLEAR THAT THE
REGULATORS SAY YOU DON'T NEED
THIS INFORMATION AND IT'S THE
ONLY WAY WE'LL REACH PHARMA.
YOU HAVE TO KNOW IF THEY DO
THOSE THINGS IN A DIFFERENT WAY,
IF THEY'RE NOT PENALIZED WHEN
THEY GO FOR APPROVAL.
>> Dr. Flaherty: THANK YOU FOR
REALLY EXCITING PRESENTATION AND
IF YOU DON'T MIND CHECKING THE
CHAT WINDOW BECAUSE THERE'S A
FEW OVERFLOW QUESTIONS AND
COMMENTS THAT WE DIDN'T HAVE
TIME TO GET TO.
LET'S MOVE TO CONCEPTS.
WE HAVE THREE NEW AND UNREISSUED
CONCEPT FOR TODAY'S DISCUSSION
AND BSA MEMBERS HAVE BEEN
REVIEWEDDERS AND INTERACTED WITH
THE PRESENTSERS IN ADVANCE BUT
WE NEED THE ENTIRETY OF THE BSA
TO ENGAGE IN TODAY'S DISCUSSION
AND ULTIMATELY VOTING FOR NEW
CONCEPTS, WE WILL VOTE TO
APPROVE DISAPPROVAL OR DEFER AND
FOR THE ONE REISSUE CONCEPT, WE
VOTE TO CONQ TO CONNECTICUT ACRD
JUST TO REMIND YOU WHEN WE'RE IN
THE VIRTUAL MODE HERE, KEEP YOUR
CAMERAS ON WHEN WE'RE IN
DISCUSSIONS AND THE VOTING PHASE
AND I WILL COUNT YOUR PRESENCE
AS A VOTE YES VO TAKE YOUR PICKD
NOTIFYING ME AND WALL OUT AND
PLEASE END INDICATE YOU ARE
ABSTAINING AND STATE YOUR NAME.
THE FIRST IS A NEW RFA AND SO
COOPERATIVES AGREEMENT AND
TRANSLATIONAL RESEARCH AND AND
VACCINE AND IT'S GOING TO
PRESENT AND THE SUBCOMMITTEE IS
BEING CHAIRED BY DORTHY AND MARK
AND BOB ARE MEMBERS OF THE
SUBCOMMITTEE AS WELL AND REBECA,
PLEASE TAKE IT AWAY.
DIVISION OF CANCER CONTROL AND
POPULATION STUDIES AND THE
DIVISION OF CANCER BIOLOGY AND
THE CENTER FOR GLOBAL HEALTH.
THE PURPOSE OF THE RFA IS TO
SUPPORT BASIC AND TRANSLATIONAL
RESEARCH AND IT WILL GUIDE THE
DEVELOPMENT OF A PREVENTATIVE OR
NEED YOU'D I CAN WITH THE GOAL
TO PREVENT AND TREAT KS AND
OTHER KSHV AND OTHER ASSOCIATED
DISEASES.
THERE ARE FOUR KS TYPES
EPIDEMIOLOGICALLY AND CLASSIC
KS, TYPICALLY EFFECTS ELDERLY
MEN OF MEDITERRANEAN DISSENT AND
AN DEMIC KS WHICH OCCURS
PRIMARILY IN CENTRAL AND
SOUTHEAST AFRICA AND IT'S VERY
AGGRESSIVE AND IMMUNO
SUPPRESSION ASSOCIATED KS OCCURS
IF TRANSPLANT PATIENTS AND
EPIDEMIC KS OR AIDS RELATED KS
JUST WANT OF THE POST COMMON HIV
ASSOCIATED TUMORS IN THE U.S.
AND THE MOST COMMON IN AFRICA
NEXT SLIDE, PLEASE.
RSHV IS HUMAN HERPESES VIRUS 8
IT WAS DISCOVERED IN
FIRST-DEGREE 9 AND THE CAUSE
TIVE AGENT OF KAPOSI SARCOMA AND
MULTI CENTRIC CASTLE MEN DISEASE
AND SIM LOMA ASSOCIATED WITH MCD
AND CYTOKINE.
THIS IS KS MOST MUCH OCCURS IN
INDIVIDUALS WITH HIV WITH 90% OF
THE CASES OCCURRING IF LOW AND
MIDDLE INCOME COUNTRY.
WITH OVER TWO-THIRDS OF THE
CASES OCCURRING IN SUB SA HER
ENTER AFRICA WHERE IT'S
SIGNIFICANTLY CAUSE OF MORBIDITY
AND MORTALITY.
IT'S IMPORTANT TO NOTE THAT WITH
RESPECT TO THE HIV EPIDEMIC AND
KS INCIDENTS, COMBINATION ANTI
RETRO VIRAL THERAPY DID
INITIALLY DECREASE THE INCIDENTS
OF KS IN THE UNITED STATES AND
OTHER DEVELOPED COUNTRIES AND
HOWEVER, THE DECREASE IN KS THAT
IS PLAT AUD AND KS IS STILL ONE
OF THE MOST COMMON MALIGNANCY
ASSOCIATED WITH HIV.
EVEN WHEN HIV IS WELL
CONTROLLED.
NEXT SLIDE, PLEASE.
THIS SLIDE DEMONSTRATES A STUDY
AT FOUR SITES IN EAST AFRICA.
IT FOLLOWED 180 ADULT S WITH
NEWLY DIAGNOSED HIV KS IN KENYA
AND UGANDA AND DESPITE BEING ON
SEA ART, WITH 46 OF THE PATIENTS
AT THIS STAGE PROGNOSIS AND
SURVIVAL IS POOR.
IN THIS STUDY, 33% OF THE
PATIENTS HAD DIED BY SIX MONTHS.
NEXT SLIDE, PLEASE.
NOW I'D LIKE TO PROVIDE SOME
BASIC INFORMATION REGARDING KSA
PREVALENCE AND KS AND KSV.
CHILDREN ARE INFECTED EARLIER IN
LIFE AND IN SOME COUNTRIES HAVE
AN 83% PREVALENCE BY AGE 19.
IN NORTH AMERICA, AND MOST OF
AUTOPSY UP, OVER ALL ZERO
PREVALENCE IS LOW BUT HIGHER IN
MEN WHO HAVE SEX WITH MEN, MSM
AND PERSONS FROM ENDEMIC AREAS
IN THE U.S., KHS AND IS 365% IN
HIV POSITIVE MSM AND 20% TO 30%
IN THE HIV NEGATIVE MSM AND
INCIDENTS OF KS IN THE U.K.
PEOPLE WITH HIV IS DECREASING
WITH COMBINATION ANTI RETRO
VIRAL THERAPY HOWEVER, INCIDENTS
IS INCREASING IN YOUNG BLACK MEN
IN THE SOUTH.
IN PARTS OF AFRICA, INCIDENTS OF
KS REMAINS HIGH EVEN WIDESPREAD
USE OF CR AND MULTI CENTRIC
CASTLE MAN DISEASE HAS BEEN
FOUND TO REPRESENT ALSO CAL KS
IS A DISEASE OF THE ELDERLY AND
THE HIV INFECTED POPULATION IS
AGING IN THE U.S.
THERE ARE CONCERNS THAT WE MAY
SEE AN INCREASE IN KS AS BOTH
HIV POSITIVE AND HIV NEGATIVE
MEN WHO HAVE SEX WITH MEN WITH
HSHV INFECTION AGE.
KSHV IS OFTEN FOUND IN ORAL
FLUIDS AND EVIDENCE TO DATE IND
INDICATES THAT THIS IS THE MAIN
ROUTE OF SPREAD.
HOWEVER, MANY QUESTIONS REMAIN
REGARDING PRINCIPLE MODES OF
TRANSMISSION.
IN AFRICA, ACQUISITION PRIMARILY
OCCURS DURING CHILDHOOD.
IN NON-ENDEMIC AREAS, SESSI IT S
IN MSN.
THE ROLE OF HETEROSEXUAL
TRANSMISSION REMAINS IN
CONCLUSIVE AND A PARSE TO VARY
IN DIFFERENT PARTS OF THE WORLD.
NEXT SLIDE, PLEASE.
THE DOC PARTICIPATING IN THIS
CURRENT CONCEPT PROPOSAL
DEVELOPED AN RFA INVESTIGATION
OF THE TRANSMISSION OF KSHV NINE
RO1 GRANTS WERE AWARDED AND THE
GOAL OF THE RFA WAS TO ADVANCE
OUR KNOWLEDGE OF KSHV
TRANSMISSION.
AREAS OF RESEARCH ADDRESSED AND
FUNDED GRANTS INCLUDES
UNDERSTANDING THE STEPS IN KSHV
INFECTION AND THE CHARACTERISTIC
OF THE INITIAL IMMUNE RESPONSE
TO KSHV AND KSHV IN HIGH-RISK
GROUPS AND UNDERSTANDING THE
BEHAVIORAL ENVIRONMENTAL GENETIC
RISK FACTORS FOR KSHV.
NEXT SLIDE, PLEASE.
THE MSA, THE NCI, BSA
SUBCOMMITTEE HAS BEEN DEFINING
GAPS IN OUR UNDERSTANDING AND IN
INFECTION AND SINCE AT FIRST
CONVENED.
WITH NCI'S DEVELOPMENT, OF THE
KSHV TRANSMISSION RFA, THE BSA
AD HOC WORKING GROUCH ENDORSED
BY THE BSA.
NEXT SLIDE, PLEASE.
IN OCTOBER OF 2021, THEY HELD A
VIRTUAL STATE OF THE SCIENCE
WORKSHOP.
EXPERTISE ACROSS THE SPECIFICS
TRUONIMMUNOLOGY AND DISCUSSING E
BENEFITS AND FEASIBILITY OF
DEVELOPING A VACCINE AGAINST
KSHV AND THEY DISCUSSED GAPS IN
KNOWLEDGE AND REGARDING KSHV
TRANSMISSION, EPIDEMIOLOGY AND
IMMUNITY TO HERPES VIRUSES, THEY
DISCUSSED LESSONS LEARNED FROM
VACCINE DEVELOPMENT TO OTHER
VIRUSES AND INCLUDING ON GOING
WORK DEVELOPING APP EBV VACCINE.
THEY HAD DISCUSSIONS IN THE
CHALLENGES AND VACCINE
DEVELOPMENT AND FORMULATION,
TESTING, AND IMPLEMENTATION.
IT'S A WORTH WHILE ENDEAVOR AT
THIS TIME.
THE MEETING WAS OPEN TO THE
PUBLIC AND A STATE OF THE
SCIENCE PAPER WAS GENERATED.
NEXT SLIDE, PLEASE.
THE SCOPE AND EXPECTATIONS OF
THE RFA.
LIKE TO PERFORM RESEARCH TO
BETTER DEFINE THE INITIAL STEPS
OF INFECTION WITH KSHB AND THE
PRIMARY MEANS OF PERSON TO
PERSON TRANSMISSION AND
DIFFERENT POPULATIONS THAT CAN
BE TARGETED WITH A VACCINE.
IDENTIFICATION AND A EVALUATION
OF KSHV STRUCTURAL AND NON
STRUCTURAL TARGETS AND FOR A
POTENTIAL KSHB VACCINE.
AND DEVELOPMENT OF ANIMAL MODELS
AND TO STUDENTS A PROTOCOL
VACCINE AND TESTING OF CAP DATES
AND STUDIES TO ASSESS HOW THE
ADVOCACY OF A PROMISING VACCINE
CAN BE OPTIMIZED, FOR PEOPLE
WITH HIV.
OPTIMIZIZATION AND
STANDARDIZATION OF DETECTION
METHODS.
THE OVER ALL GOAL IS TO EXPAND
THE RESEARCH SCOPE AND LEVERAGE
THEY MADE THROUGH THE PREVIOUS
RF A AND TO SUPPORT BASIC AND
TRANSLATIONAL RESEARCH THAT WILL
GUIDE THE DEVELOPMENT OF A
VACCINE.
NEXT SLIDE, PLEASE.
WE PERFORMED A PORTFOLIO
ANALYSIS FORTIS CAL YEAR '21 AND
'22.
OVER TWO ACTIVE RESEARCH PROJECT
GRANTS AND NIDCA AND ADDRESSING
KSHV VACCINE DEVELOPMENT.
THE NCI HAS 56 FINANCED GRANTS
THAT IN SOME WAY ADDRESS K IS
SHV RELATED RESEARCH, NINE OF
WHICH WERE FUNDED THROUGH THE
PREVIOUS RFA.
SIX NCI FUNDED GRANTS ADDRESS
ISSUES SUCH AS VIROLOGY, EARLY
INFECTION, ET CETERA, AND THAT
COULD POTENTIALLY BE IMPORTANT
IN VACCINE DEVELOPMENT.
OTHER ICs IN THE PORTFOLIO
FUNDED 17 GRANTS THAT IN SOME
WAY ADDRESS KS OR KSHV AND WHEN
COMPARED TO FISCAL YEAR 2015 AND
2016.
NEXT SLIDE.
PLEASE.
THEY ARE PROPOSING A $3 MILLION
BUDGET FOR EACH OF TWO RECEIPT
DATES WITH A 15 MILLION OVER ALL
REQUESTED FOR FIVE YEARS AND FOR
EACH OF TWO RECEIPT DATES.
WHICH WOULD INCLUDES $30 MILLION
TOTAL THIS WOULD SUPPORT THREE
TO FOUR AND THE CONCEPT HAS BEEN
REVIEWED BY THE OAR AND DEEMED
AIDS APPLIANCE.
A UO1 MECHANISM IS BEING
PROPOSED PRIMARILY BECAUSE OF
THE BREADTH OF INTEREST IN
COMPLEXITY THE SCOPE OF SCIENCE
AND NEEDS TO BE CATALYZED
THROUGH THIS INITIATIVE AND
INTERNATIONAL PARTNERSHIPS IN
LOW AND MIDDLE INCOME COUNTRIES
WILL BE FACILITATED BY PROGRAM
ENGAGEMENT IN ORDER TO OPTIMIZE
SUCCESS.
NEXT SLIDE, PLEASE.
>> THANK YOU, REBECA.
LET'S GET IT STARTED IN
DISCUSSION.
>> SURE.
SO THANK YOU, REBECA THAT WAS A
NICE PRESENTATION.
Dr. DOROSHOW AND HE WASN'T
ABLE TO MAKE THE MEETING BUT HE
REVIEWED THE CONCEPT STATEMENT
AND THE POWER POINTS AND
PROVIDED FEEDBACK OVER E-MAIL.
SO IN GENERAL, THE COMMUNITY
MEMBERS WHICH REPRESENTS A
MULTI-COLLABORATIVE EVENT ACROSS
THE NCI DIVISIONS AND CENTERS.
WE THOUGHT THAT THE FOCUS OF THE
RFA IS CERTAINLY HIGHLY
IMPORTANT IN THE NEED IS REALLY
GREAT, ESPECIALLY IN THE SUB
ZAHAR AN AFRICA.
WE GOT THAT THERE WAS A LOGICAL
PROGRESSION AND A STRONG
FOUNDATION FOR THE DEVELOPMENT
OF THIS RFA AND INCLUDING HAVING
THIS MULTI-DISCIPLINARY MEETING
ON THIS TOPIC AND
RECOMMENDATIONS FROM THE BSA AD
HOC COMMITTEES TO ADDRESS THE
KSHB AND ALSO THE CURRENT WAVE
OF RESEARCH ON THE DEVELOPMENT
OF OTHER TYPES OF VACCINES AND
FURTHERMORE SOME OF THE
ATTRIBUTES OF THE VIRUS MAKES IT
FEASIBLE TO TARGETED FOR A
VACCINE.
AND FINALLY THE PORTFOLIO
ANALYSIS I THINK DEMONSTRATED
THAT THE PROPOSAL, THIS PROPOSED
RFA WILL FILL A GAP OR BE
COMPLIMENTARY TO OTHER EXISTING
FUNDINGS FOR RESEARCH ON THIS
AREA.
WE DID HAVE OF A FEW CONCERNS
WHICH I THINK WERE ADDRESSED BUT
REBECA AND BOB, ONE WAS THE
POTENTIAL OVERLAP BETWEEN TARGET
AREAS IN THE PRIOR RFA VERSUS
THE PROPOSED RFA BUT WE WERE
SURE THAT THIS RFA IS THAT
DEVELOP AND THE VACCINES AND WE
HAVE QUESTIONS AND WHETHER THE
RESULTS FROM THE PRIOR RFA OUR
INVESTIGATORS WHO ARE ABLE TO
SECURE FUNDING AND WHAT REBECA
HAD MENTIONED IS THAT PROBABLY
THE INITIATION FEE PROPOSED RFA
WOULD PROBABLY OCCUR WHILE THE
PRIOR RFA RESULTS ARE BEING
GENERATED.
WE, I THINK, Dr. DOROSHOW HAD
QUESTIONS ON THE WORK OF THE EVB
EPSTEIN BAR VIRUS VACCINES WILL
HELP INFORM THE KSHV VACCINE AND
IN DEED THE RESPONSE WAS YES.
AND FINALLY, OR I GUESS NOT
FINALLY BUT THE OTHER
RECOMMENDATION THAT WE HAD IS
THAT THERE'S A PROPOSAL TO GET
THE UO1 INVESTIGATORS TOGETHER
TO SHARE INFORMATION WITH EACH
OTHER BUT WE THOUGHT IT MIGHT BE
GOOD TO OPEN IT UP TO OTHER
INVESTIGATORS THAT HAVE
CONDUCTED RESEARCH IN THIS
PARTICULAR AREA.
AND THEN FINALLY, THERE WAS A
QUESTION AS TO WHETHER CLINICAL
TRIALS ARE GOING TO BE REQUIRED
FOR THIS RFA AND THE RESPONSE
THAT IS THE CLINICAL TRIALS WILL
BE OPTIONAL.
SO, THAT IS IN SUMMARY OUR --
WHAT WE RECOMMENDED AND YOU
KNOW, WHAT WE FELT ABOUT THE RFA
AND WE'RE VERY SUPPORTIVE OF IT.
>> I HIGHLIGHTED YOUR COMMENTS
BUT IF YOU HAVE ANY ADDITIONAL
COMMENTS.
>> YEAH, NO, I THINK IT'S REALLY
WELL DONE BACKGROUND AND
PRESENTATIONS OF THE NEED AND
YOU KNOW, EARLIER TODAY WE HEARD
ABOUT FUNDINGS FORCES AND HOW
THIS GETS FUNDED IS A LITTLE BIT
DIFFERENT AS WELL WHICH IS
FAVORABLE IN TERMS OF
DEVELOPMENT OF THE VACCINE.
THE THING, THE OTHER QUESTION I
HAVE OVER TIME IS THIS IS A
MAJOR ISSUE FOR SUB ZAHAR ANT
AFRICA AND FOLKS HIV NEGOTIATE
IT TIVE AND THEY AGE IN THE
UNITED STATES AND I DON'T THINK
WE KNOW THE ANSWER TO THAT YET
SO HOPEFULLY DEVELOPMENT OF A
VACCINE WOULD GENERATE A VACCINE
THAT'S AFFORDABLE AND I MEAN, WE
NEED THE VACCINES TO THE VACCINE
FIRST.
>> WE CLARIFY IT'S CLINICAL
TRIALS OPTIONAL AND THAT'S ALL I
HAVE TO ADD.
>> YOU ARE MUTED.
>>
>THANK YOU.NICE PRESENTATION ANY
TIMELY.
I WONDER IF YOU HAD THOUGHT
ABOUT COLLABORATIONS WITH THE
NIEDCR BECAUSE ONE OF THE
IMPORTANT ASPECTS OF ORAL KS, AS
YOU KNOW, IS ASSOCIATED WITH HIV
POSITIVE INDIVIDUALS AND THAT
WOULD BE A NICE COLLABORATION TO
BUILD ON.
BUT, ONE OF THE THINGS THAT I AM
THINKING ABOUT, AS YOU WENT
THROUGH THE PRESENTATION, WAS
THAT YOU HAVE ABOUT IT'S 80%
ZERO POSITIVE.
IN THE EVENT THIS VACCINE
MATERIALIZES, TRYING TO THINK
ABOUT HOW THIS WOULD BE SAY
SOLVED IN TERMS OF TRANSMITTING
TO INDIVIDUALS WHO REALLY NEEDS
THE VACCINE, HAVE YOU THOUGHT
ABOUT HOW THIS MIGHT BE WORKED
OUT IN TERMS OF COLLABORATING
WITH GOVERNMENTS AND THESE
COUNTRIES AS WELL AS CHINESE
GOVERNMENTS?
HAS THERE BEEN DISCUSSIONS THAT
HAS BEEN ON GOING WITH THIS?
>> WELL, AS FAR AS COLLABORATION
WITH THE NIDCR WHEN WE STARTED
THIS INITIATIVE, WE DID WORK
WITH THE NIDCR INITIALLY BUT
THERE WERE PROGRAMMATIC ISSUES
THAT PUT IT OUT OF THEIR REALM
OF PARTICIPATION.
SO WE'VE MOVED FORWARD I BELIEVE
WE HAVE TO MOVE DOWN THE
PIPELINE BEFORE WE CAN START
CERTAINLY WILL WORK THROUGH NCI
AS COLLABORATIVELY AND AS
FORWARD-THINKING AS WE CAN
POSSIBLY BE.
TO GET THIS VACCINE, IF
DEVELOPED, TO THE POPULATIONS
THAT MOST NEED IT.
I THINK THAT'S THE VALUE OF
DOING THIS RESEARCH FOR VACCINE
THAT PROBABLY WOULDN'T BE
DEVELOPED COMMERCIALLY.
>> I HAVE ONE OTHER COMMENT.
IS THAT OKAY?
>> YES, PLEASE.
>> ONE OF THE OTHER THINGS THEY
ARE THINKING ABOUT IS THIS VIRUS
IS DIFFERENT TO EVE OR ECV THAT
EFFECTS MOST OF THE OF THE
POPULATION AND YOU HAVE A LARGE
NUMBER OF ONCO GENETIC OR RF AS
WELL AS QUEEN'S THAT ARE
INVOLVED IN IMMUNE EVASION.
DO YOU REALLY THINK WHICH AT THE
POINT WHERE WE ARE READY TO
START PUTTING EFFORT INTO THE
DEVELOPING THE VACCINES WITH
THIS HUGE KNOWLEDGE GAP THAT IS
EXISTING CURRENTLY FOR THE
DEVELOPING SUCH A VACCINE?
>> I'M GOING TO SHOOT THAT ONE
OVER AND.
>> YOU KNOW ONE CAN ALWAYS SPLIT
FOR THESE THINGS AND WE HAVE
ENOUGH KNOWLEDGE AT THIS POINT
WE CAN MOVE FORWARD.
WE HAVE A PRETTY GOOD IDEA OF
SOME OF THE SURFACE PROTEINS
THAT IT'S ONLY TRANSMITTED IN
CERTAIN SETS SO ONE HAS THE
SENSE THAT ONE MAY NOT TO TWEAK
THE IMMUNE RESPONSE TO THIS
VIRUS THAT MUCH TO HAVE AN
EFFECTIVE VACCINE.
WE WON'T KNOW UNTIL WE DO IT BUT
I THINK IT'S WORTH WHILE TO GIVE
IT A SHOT AND WE LEARN ABOUT THE
BIOLOGY FOR DEVELOPING A
VACCINE.
>> Dr. Flaherty: CAN YOU MAKE A
MOTION?
>> I MOVE TO VOTE.
I MOVE TO APPROVAL.
>> CAN I GET A SECOND.
>> SECOND, PLEASE.
THANK YOU, MARK.
>> Dr. Flaherty: OKAY.
ANY FURTHER DISCUSSION?
MOTION IS FOR APPROVAL.
AND YOUR PRESENCE ON CAMERA IS
VOTED APPROVAL.
SO YOU NEED TO RAISE YOUR HAND
OR VOICE DISAPPROVAL IF YOU ARE
VOTING IN THAT DIRECTION.
I SEE YOU ARE HERE NONE.
ANY ABSTENTIONS?
NO.
>> IT'S UNANIMOUS.
>> THANK YOU.
>> WE'VE REACHED THE POINT OF
BREAK.
THANK YOU VERY MUCH.
FOR THAT REPRESENTATION AND
DISCUSSION.
I THINK WE -- IT'S SAFE TO SAY
WE INVESTED SOME OF OUR BREAK IN
THE Q&A THAT FOLLOWED JIM'S
PRESENTATION LET'S SHRINK OUR
BREAKDOWN TO FIVE MINUTES.
WE HAVE TO SOME HAVE MAUD' CO T.
>> Dr. Flaherty: WITH SAM AND
JENNIFER AND ALL THREE WITH THE
DISCUSSION OF CONCEPT AND
SUZANNE COULDN'T JOIN US TODAY
FOR THE MEETING.
WE HAVE THE DISCUSSION AND GET
US STARTED WHEN WE GET TO THAT
POINT AND SAM AS YOU CAN SEE IS
WITH US SUL.
FOR TARGETING PROTEINS IN
CHILDHOOD CANCER.
THE OTHER MEMBERS OF THE TEAM
WILL BE ON FOR QUESTIONS AND
ANSWERS AFTERWARDS.
FIRST POINT I WANT TO EMPHASIZE,
IS THE IMPORTANCE OF ACTIVE
TARGETED AGENTS, HAD WE HAVE
ACTIVE AGENTS FOR A CANCER WE
KNOW WHAT TO DO IN ORDER TO
IMPROVE OUTCOMES FOR CHILDREN
FOR CHILDHOOD ALL LOOKING ON FOR
2000 ONWARD THERE'S A 50%
DECLINE IN MORTALITY WE HAVE
INHIBITORS AND CAR T CELLS ARE
AVAILABLE IN THE WE SEE THIS
DECLINE FOR NON-HODG NON HOW MUH
LYMPHOMA AND CD TARGETED 20 AND
I AM H20 ANDOTHERS AND FINALLY N
LYMPHOMA 80% DECLINE OF
MORTALITY AND ACTIVATIONS AND
LOOKING AVAILABLE IN THE LAST 10
YEARS.
WE CAN IMPROVE THAT OUTCOME WHEN
WE HAVE THESE ACTIVE NEW
TARGETED AGENTS.
IT'S A DIFFERENT STORY WHEN YOU
LOOK AT SOFT TISSUE CANCER,
CANCER LIKE SARCOMA AND WE LOOK
AT BONE CANCER AND THOSE INCLUDE
CANCERS LIKE OSTEO CAR COMA SO
IT EMPHASISES NEEDED FOR CAN ZAR
AND IN ORDER TO CURE MORE WITH
THESE CANCER AND MANY OF THESE
HARD TO TREAT CANCER WHICH HAS
BEEN LITTLE PROGRESS ARE DRIVEN
BY FUSION ONCA PROTEIN.
IT BUILDS UPON THE NCI MOONSHOT
INITIATIVE.
THERE WERE NINE GRANTS U54
GRANTS IN SIX DIFFERENT FUSION
ONCA PROTEINS AND STUDY FROM
REMODELING, PHASE SEPARATION,
MODEL DEVELOPMENT, PRO TAX AND
APPLY STRATEGIES AND STUDYING
CRITICAL DEPENDENCIES AND
PROGRESS WAS MADE.
Dr. BERTAGNOLLI DESCRIBED THE
ADVANCES, THE IDENTIFICATION OF
ETV6 IS A CRITICAL DEBEN SEE AND
OTHER OTHER ADVANCE AND I DON'T
HAVE TIME TO GO THROUGH ALL OF
THESE BUT JUST TO MENTION A FEW.
KIM AND HER TEAM SHOWED THAT
TRIM 8 REGULATES EWS51 PROTEIN
LEVELS AND EITHER TOO MUCH EWS51
OR TOO LITTLE IS DETERMINED BY
THE ACTIVITY CAN BE TOXIC TO
EWING SARCOMA CELLS AND AS WELL,
JOHN BUSHWELLER HAS IDENTIFIED
SMALL MOLECULES THAT STABILIZE
FLIGHT 1 AND ANOTHER
TRANSCRIPTION FACTORS THIS
SHIFTS THE EQUILIBRIUM AWAY FROM
DNA BINDING AND INHIBITS THE
ACTIVITIES OF THESE
TRANSCRIPTION FACTORS AND
ANOTHER EXAMPLE, CHARLES
MULLIGAN AND HIS U54 TEAM
IDENTIFIED A CRITICAL DEPENDENCY
AND REARRANGED LEUKEMIA AND THIS
IS SOMETHING THAT CAN HAVE
IMMEDIATE CLINICAL TRANSLATION
BECAUSE MODELING AND CAN
BE USED FOR DRUG SCREENING.
WE DID HAVE EX INTERPRETTAL
SCIENTIFIC CONSULT APARTMENTS TO
ADVISE US ON NEXT ACCEPTS TO
FOLLOW THROUGH THE CONSORTIUM.
WHERE NCI MAKES CONTRIBUTIONS
AND ANOTHER DIVERSIFYING THE
PROTEINS INCLUDED IN FUTURE
EFFORTS AND THEY RECOMMENDED
APPLYING STATE OF THE ART
METHODS TO DIRECTLY TARGETING
INFUSION ONCA PROTEINS AND THEY
HAVE SUCH A STATE IT'S POSSIBLE
TO -- AND INNOVATIVE DRUG
DEVELOPMENTS TO ALL OF THE
INVESTIGATORS THAT ARE MEMBERS
OF THE NETWORK AND TO DO
DILIGENCE IN THE REASSURE
OURSELVES IT'S SCIENTIFIC
OPPORTUNITIES ARE AVAILABLE AND
THERE'S INTEREST IN THE RESEARCH
COMMUNITY WE ORGANIZED WEBINAR
SERIES LAST YEAR ON NOVEL
CHEMICAL APPROACHES FOR
TARGETING FUSION ONCA PROTEINS
AND WE HAD 1,000 HIGH LEVEL OF
INTEREST IN THIS TOPIC AND
REALLY THE -- WE CAME AWAY WITH
MORE ENTHUSIASM I DON'T HAVE
TIME TO GO THROUGH THE
OPPORTUNITIES BUT THE METHODS
FOR PROTEIN DEGRADATION FOR
SCREENING, CO VARIANT INHIBITORS
AND ALL OF THESE THINGS CREATE
AN OPPORTUNITY FOR PROGRESS.
SO, THE NETWORK THAT WE'RE
PROPOSING HAS TWO COMPONENTS.
THE FIRST IS FOR PROJECTS TO
BETTER UNDERSTAND THE MECHANISMS
OF FUSION DRIVEN ONCAGENESIS AND
SO THOSE UO1 GRANTS STUDY THE
PATHWAY BY WHICH THE FUSIONS CAN
CAUSE CANCER, WHAT'S THEIR
COMPLEXES THAT THESE FUSION
ONCOPROTEINS ARE INVOLVED WITH
AND THE INTERACTIONS WITHIN THE
COMPLEX AND WHAT ARE THE ROLES
LIKE NON CODING RNAs OR IN THE
FUNCTION OF THESE FUSION
ONCOPROTEINS AND THE SECOND ARE
THE NEXT GENERATION CHEMISTRY
CENTERS AND THESE ARE LARGER
GRANTS THAT ALLOW SEVERAL SEEMS
TO WORK TOGETHER AND WITH
COMPLIMENTARY RESEARCH AND
EXPERTISE TOWARDS A COMMON GOAL
AND ANY OF THAT COMMON GOAL IS
ACTIVITIES FOR THESE AND
IDENTIFYING INHIBITORS OF FUSION
ON CO PROTEIN ACTIVITY AND
EITHER DIRECTING INHIBITORS
BLACKING CRITICAL INTERACTIONS
AND OR DEGRADING THE FUSION ON
CO PROTEIN OR THE CRITICAL DEPEN
DEN SEIZE.
THESE A SCHEMATIC OF THE HOW WE
I AM VISION OF THE NETWORK OF
STEERING COMMITTEE WITH THE
PIs OF THE UO1 AND THE UM1s.
THE UM1s AND THE UO01s HANK
OR THE NETWORK BUT OTHER
GRANTEES CAN BE ASSOCIATE
MEMBERS OF THE NETWORK AND THESE
ARE STATION FUSION THROUGH OTHER
NCI FUNDED GRANTS OR THESE
STUDYING FUSION ONCOPROTEINS AND
INCLUDING PATIENTS ADVOCATES AS
WELL AND BETWEEN THE UM1 COMES
THE RESEARCH TEAMS OUTSIDE OF
THE NETWORK EVEN AND THE UM1
BUDGE LET'S HAVE 15% OF THEIR
OVER ALL BUDGET TO APPLY THE
STRATEGIES WITH INTERACTIONS
BETWEEN THE UO1 AND THE UM1s.
THE AS A RESULT OF OUR
DISCUSSIONS WITH THE BSA
SUBCOMMITTEE WE WANT TO -- THE
NUMBER ONE IS FOCUS OF PROTEIN
THAT HAVE A HIGH-RISK OF FAILURE
AND LITTLE PROGRESS IN
IDENTIFYING TARGETED AGENTS AND
WHILE PARTICULARLY ENCOURAGED
APPLICATIONS WHERE THEY SOLID
TUMORS AND BRAIN TUMORS AND
EXCLUDE FUSION O ON CO ONCOPROTD
DATA SHARING AND COLLABORATE
WITH OTHER NCI PROGRAMS SUCH AS
THE CHILDHOOD DATA INITIATIVE TO
ENSURE USABILITY AND
ACCESSIBILITY AND SHAREABILITY
OF THE DATA.
IN TERMS OF THE BUDGET AND
LOGISTICS, THERE'S SEPARATE
RFAs, ONE FOR THE U01 AWARDS
AND THEY WERE TARGETING 325,000
DIRECTING CALLS FOR THESE AND
THE RFA FOR THE UM1 AWARDS, WE
ENVISIONED TWO UM1 AWARDS EACH
WITH $1.5 MILLION AND DIRECT
COST AND WE THE 15% OF THE
BUDGET BEING RESTRICTED FOR
COLLABORATIVE PROJECTS IN YEARS
TWO THROUGH FIVE.
WITH $8.3 MILLION ANNUALLY FOR
FIVE YEARS FROM FY24 TO FY28.
SO, OUR MARKERS OF SUCCESS
NUMBER ONE IS TUB THREE, NEW
TECHNOLOGIES AND STRATEGIES
IDENTIFYING FOR TARGETING FUSION
ONCOPROTEINS OR THEIR DEPEN DEN
SEIZE AND FINALLY, IDENTIFYING
AND DEVELOPING CHEMICAL PROBES
TOOLS OR ADVANCE LEADS THAT CAN
BE OPTIMIZED TO NEW DRUG
CANDIDATES SO THAT'S REALLY WHAT
SO MY COLLEAGUES WILL BE
AVAILABLE TO ADDRESS QUESTIONS
THE BSA MEMBERS MAY HAVE.
>> THANK YOU.
DO YOU WANT TO GET US STARTED.
>> HI, MALCOLM, THANK YOU FOR
THAT.
IT WAS A WONDERFUL PRESENTATION
AND NICELY INCORPORATED SOME OF
THE DISCUSSION TOPICS THAT WE
HAD WHEN WE MET.
WE WERE VERY ENGAGE IN
ENTHUSIASTIC ABOUT THE CONCEPT
AS YOU HAVE HEARD AND IT REALLY
BUILDS UPON THIS SUCCESS AND
LESSONS LEARNED IN THE U54
CONSORTIUM, THE QUESTION IS WHAT
IS THE NEXT STEP.
THE WE ARE NAR SERIES SHOWED A
HIGH LEVEL OF ENGAGEMENT AND
THIS IS JUST FELT TO US VERY
LOGICAL AND WE WERE EXCITED BY
THE POSSIBILITY OF BRINGING THE
UM1 MECHANISM INTO NCI WHERE WHY
THINK IT'S A COMMON MECHANISM
FOR FUNDING.
IT'S THE MECHANISM TO FUND THE
CTSAs WHICH SEVERAL OF US ARE
VERY FAMILIAR WITH AND THE NICE
PART ABOUT THE UM1 MECHANISM IS
IT'S REALLY FLEXIBLE.
SO THIS PLUS THE INCENTIVIZED
15% COLLABORATIVE RESOURCES
REALLY SEEM TO US LIKE THE RIGHT
THING TO DO.
WE REALLY HAD A COUPLE OF
QUESTIONS AND CLARIFICATIONS
WHICH WERE DISCUSSED IN TERMS OF
OVER ALL STRUCTURE AND
INTERACTIONS WITH BOTH BETWEEN
UM1 AND UO1 AND RO1s,
INTRAMURAL COMMUNITY IT ALL
SOUNDS RIGHT.
THE DATA ISSUE IS LARGE, I'LL
LET SAM WEIGH IN ON THAT BECAUSE
IT'S REALLY HIS AREA OF
EXPERTISE.
UP WITH OF THE IDEAS WE GOT
EXCITED ABOUT IS LEARNING FROM
THIS SUCCESS OF THE N3C EFFORT
IN N CAT WHERE THERE WAS A
REQUIREMENT DURING COVID TO
SHARE ALL THE ELECTRONIC HEALTH
RECORDS WITH THE NIH IN ORDER TO
SUPPORT COVID RESEARCH.
THERE REALLY ISN'T ANY REASON
WHY NCI CAN'T LEVERAGE SUCH A
EFFORT WITH THE COMPREHENSIVE
CANCER CENTERS SO THE CANCER
CENTER CONSORTIUM, WHEN THE TIME
IS RIGHT, WHEN THE QUESTION IS
RIGHT, YOU CERTAINLY HAVE THE
POLITICAL CAPITOL TO DO IS SUCH
AND I THIS I IT COULD REALLY
CAPITALIZE WELL ON THE OTHER
EFFORTS WE HEARD THIS MORNING
AND NOT I THOUGHT THE HIGH
LEVEL, LET'S NOT FOX SOMETHING
THAT'S ALREADY SOLVED AND LET'S
ATTEND TO THINGS THAT ARE STILL
BROKEN IS A REALLY PRAGMATIC
RESPONSE.
YOU KNOW, SUZIE, SAM AND I WERE
ALL VERY SUPPORTIVE AND I'LL LET
SAM SPEAK NOW.
>> THANK YOU.
OBVIOUSLY VERY ENTHUSIASTIC
ABOUT THIS.
ESPECIALLY AS A SPEED FROM THE
PEDIATRICONCOLOGIST AND ALL THET
FROM THIS PROGRAM SO FAR.
OBVIOUSLY I'VE BEEN CONCERNED
ABOUT DATA SHARING AND WE NEED
TO SEE EVERY OPPORTUNITY TO
COLLECT AND AGO AGREE GATE AND
HARMONIZE DATA LIKE THIS.
WE HAD A DISCUSSION ABOUT THE
DIFFERENT MECHANISMS THAT ARE IN
PLACE FOR A FOR FOR AGGREGATINGO
SHOW HOW RESEARCH OUTPUT FROM
THIS PROGRAM CAN BE HARNESSES
AND REPURPOSES FOR OTHER FOLKS
THAT WANT TO USE THE DATA FOR
THEIR OWN RESEARCH.
THIS IS A GREAT OPPORTUNITY HERE
AND ACROSS ALL OF OUR PROGRAMS
OBVIOUSLY.
SO THANK YOU FOR LETTING ME BE A
PART OF THIS DISCUSSION.
>> THANK YOU.
OPEN FOR FURTHER DISCUSSION.
>> WHAT HAPPENS TO THE CURRENT
PROGRAM?
IS THIS A REPLACEMENT FOR THE
CURRENT MOONSHOT PROGRAM?
>> YEAH, THE CONSORTIUM, THESE
WERE MOONSHOT PROGRAMS FIVE YEAR
AWARDS AND THEY WERE DONE TWICE
AND SO SOME OF THE AWARDS WERE,
THEY'RE ENDING ONE YEAR APART
BUT THEY WERE FIVE YEAR AWARDS
AND SO, IN SOME WAYS, THIS
BUILDS UPON THAT AND WE'LL BE A
SUCCESS FOR THAT AND THOSE
AWARDS THEMSELVES WILL NOT BE
ABLE TO CONTINUE.
IN LOOKING AT THE KIND OF POINTS
THAT THIS RFA WOULD BE POINTING
TO, I'M SURPRISED THAT THERE WAS
NOT ANY MENTION OF AN IMMUNE
LOGICAL APPROACH BECAUSE FUSION
PROTEINS ARE GOOD TARGETS AND
THEY CAN ACTUALLY BE HIGHLY
SPECIFIC AND THEY DON'T NEGATE
THE DISTRICTED KIND OF SMALL
MOLECULE APPROACH THAT IT'S
TALKING ABOUT.
BECAUSE I DON'T KNOW MUCH ABOUT
THESE TUMORS AND WE HAVE AFTER
EFFORT WITHIN NCI, PEDIATRIC
IMMUNO NETWORK NOW THAT IS
SPECIFICALLY APP APPLICATION
THAT WOULD BE RIGHT WITHIN WHAT
THOSE PROGRAMS WERE AIMING FOR.
IS THERE SOMETHING ABOUT THESE
FUSION PROTEINS THAT STIMULATES
AN IMMUNE SPONSOR THAT THERE'S
AN ACTIVE AREA OF RESEARCH AND
IN PART WE DIDN'T MENTION IT
HERE SIMPLY BECAUSE OTHERS ARE
ADDRESSING IT AND OTHER
PROGRAMS.
>> THANK YOU.
>> SEEING NO OTHER HANDS, WE CAN
MOVE TO VOTING.
JENNY, AS THE ACTING CHAIR, IT
SOUNDS LIKE YOU ARE MOVING THIS
IN SUPPORTIVE DIRECTION.
WOULD YOU LIKE IT MAKE A MOTION?
>> I MOVE TO APPROVE.
>> CAN I GET A SECOND.
>> ANY FURTHER DISCUSSION?
HEARING NONE.
THE ASSUMPTION IS VOTE OF
APPROVAL.
SO LOOKING FOR ANY DIS APPROVALS
BY RAISE OF HANDS OR VOICE.
I SEE AND HEAR NONE.
ANY ABSTENTIONS.
>> IT'S UNANIMOUS.
>> THANK YOU, ALL.
WE HAVE A REISSUANCE RFA AND
CO-OPERATIVE HAIMON TISSUE
NETWORK AND Dr. CHUAQUI WILL
PRESENT AND IT'S SHARED BY
SHELLY IRP AND CONSTITUTED BY
FELLOW ALLRIDGE AND SUSAN BAKER
AND AS NOTED, SUSAN COULDN'T
JOIN US FOR THE MEETING TODAY.
SHELLY AND NELLY ARE WITH US.
AND I'LL JUST MENTION NOW AT THE
OUTSET, THIS IS A LIMITED COMP
COMPETITION AGREEMENT AT THE
INSTITUTIONAL OR INTEREST LEVEL
AS A CONSTITUTION WE HAVE A
NUMBER OF CONFLICTS AND
ABSTENTIONS THAT COME UP AT THE
END.
SIX OF OUR MEMBERS WILL BE
ABSTAINING FROM THE VOTING
PROCESS.
AS WELL AS DISCUSSION WHEN WE
GET THERE.
SO JUST A FLAG THAT AS NON
UNUSUAL FOR LIMITED COMPETITION
INSTITUTIONAL LEVEL AWARDS LIKE
THIS.
SO WITH THAT SAID, RODRIGO, GO
AHEAD WITH THE PRESENTATION.
>> SORRY, DO YOU HAVE A QUEST
QUESTION?
>> SO THE COMPARATIVE TISSUE
NETWORK IS AN NCI SUPPORTED
RESEARCH WHOSE MAIN GOAL IS
INFORM PROVIDE HIGH-QUALITY
SPECIMEN MAINLY FOR BASIC AND
EARLY TRANSLATIONAL RESEARCH AS
WELL AS ASSAY DEVELOPMENT.
NEXT SLIDE.
THE PROBLEM HAS BEEN FUNCTIONING
WITH HIGH PRODUCTIVITY SINCE
1987 AND HAS A WELL STRUCTURE IN
CONSISTING OF SIX DIVISIONS,
FIVE ADULT DIVISIONS THAT
DISTRIBUTE SPECIMENS ACCORDING
TO THE GEOGRAPHIC LOCATION OF
THE THE ADULT DIVISIONS WORK
WAYS BETWEEN ONE AND AND HAVE
SIGNIFICANTLY CONTRIBUTED TO BIO
SPECIMEN SCIENCE AND BIOBANKING.
IT'S A UNIQUE REPOP TORI UNLIKE
ANY FUNDED BY THE NCI.
IF YOU LOOK AT THE RIGHT COLUMN,
IT IS BASED AN PROSPECTIVE
PROCUREMENT MODEL AND IN
RESPONSE TO AN INVESTIGATOR
REQUESTING THOSE SAMPLES.
WITH LIMITED STORING.
THE PROSTHETIC PROCUREMENT
ALLOWS THE PROCESSING OF THE
SAMPLES TO BE CUSTOMIZED TO THE
INVESTIGATORS NEEDS AND THERE'S
FREQUENT COMMUNICATION BETWEEN
INVESTIGATOR AND THE CHTM.
IN THE NETWORKING ON THE OTHER
HAND, ALLOWS FOR A WIDE RANGE OF
SAMPLES TO BE COLLECTED
INCLUDING RARE SAMPLES.
THEY ARE PROVIDED WITH BASIC
DAMNGRAPH I CAN AND HISTO PATH S
REQUESTED FOR MORE DATA.
FRESH AND FROZEN SAMPLES, WHICH
ARE USUALLY THE LIMITING FACTOR
IN BIO REPOSITORIES CONSTITUTE
ABOUT 50% OF THE SAMPLES AND
THAT WERE SHIPPED IN THE LAST
FIVE YEARS.
THE CHTN IS AN OPEN RESOURCE IN
SEARCH OF THE ENTIRE SCIENTIFIC
COMMUNITY WITH A LOW PRIZE, LOW
BAR AND EASY ACCESS TO THE
SAMPLES.
NEXT SLIDE, PLEASE.
SO, THE CHTN CONTINUES TO WORK
WITH HIGH PRODUCTIVITY AND THIS
DATA REFERENCES TO FIVE YEARS,
2017-2021 AND OVER 1800
RESEARCHERS WERE SEARCHED, THREE
QUARTERS OF THEM WERE ACADEMIC
INVESTIGATORS, AND MOST OF THEM
ARE ONE GUARANTEE AND 23%
INVESTIGATORS IN INDUSTRY AND
OTHER GOVERNMENT IN INTRAMURAL
DOD.
ALSO, OVER 175,000 SAMPLES WERE
DISTRIBUTED.
YOU CAN SEE ON THE LEFT GRAPH,
THE DISTRIBUTION OF SAMPLES IN
THE LAST 10 YEARS, AND ON THE
RIGHT SIDE, YOU CAN SEE HALF THE
SAMPLES PRETTY MUCH WHY FRESH OR
FROZEN.
OVER 500 PUBLICATIONS WERE
GENERATED DURING THIS PERIOD
USING CHDN SAMPLES AND 55
PATENTS, MOST BY INDUSTRY BUT
ALSO WITH CONTRIBUTIONS BY AK
ACADEMIA, DESPITE THE PROBLEM
HAD TO FACE SOME CHALLENGES
DURING THIS PERIOD, DESPITE THE
INCREASED THAT WAS APPROVED FOR
FUNDING IN THE LAST
RECOMPETITION, THE POLICY OF
CUTS TO GRANTS OR RFAs LED TO
THE CURRENT FUNDING AND LAST ONE
WAS OPEN COMP FISSION AND ONE
DIVISION, THE SOUTHERN DIVISION
THE TEENS WAS WAS REPLACED AND
IT PROCESSES THAT MEANT
SIGNIFICANT EFFORTS AND
DIFFERENT LEVELS INCLUDING
TRAINING, AND RE-ASSIGNMENT OF
INVESTIGATORS, AND LEGAL
AGREEMENTS, AND HIRING.
AND OF COURSE, COVID IS MOST OF
SCIENCE AND IMPACTED THE
PROGRAM.
NEXT SLIDE, PLEASE.
AS I SAY, SOME DISTRIBUTED BY
CHDN AND UNIVERSITIES IN THE IN
CON HAVE THE CENTER
INVESTIGATORS AND OF COURSE
INTRAMURAL RESEARCHERS IN THE
RIGHT-OF-WAY WE INCLUDE AND WIDE
RANGE OF CURRENT HIGH-THROUGHPUT
TECHNOLOGIES AND IN WHICH
SAMPLES WERE USED FIVE YEARS AND
ALL THE WAY TO GENOMICS AND
TRANSCRIPT TOMB I CANS.
DEMONSTRATING THE HIGH-QUALITY
OF THE SAMPLES.
LAST YEAR, THE REVIEW WAS
CONDUCTED TO OUR PROGRAM FOR THE
CHTN WHICH REVIEWSERS FOR
BACKGROUNDS.
THERE WAS A HIGH VALUE FOR THE
RESEARCH COMMUNITIES AND
EMPHASIZING OUR ONE GUARANTEES
AND THE PROSPECTIVE MODEL PLACE
A KEY ROLE IN BASIC AND EARLY
TRANSLATIONAL RESEARCH AND AND
THERE WAS SUPPORT FOR A LIMITED
COMPETITION TO MAINTAIN THE DA
BILL TEE OF THE PROGRAM AND
REALLY THERE'S NO ALTERNATIVE TO
THE COMMERCIAL RESOURCES CANNOT
PLY THE FULL RANGE OF SERVICES
AND INCLUDING THE TYPES OF
SAMPLES AND THE PRICING.
GENRE PROPOSING UP TO SIX AWARDS
UNM GRANT AND AS I SAID THE
LIMITED COMPETITION PROVIDED WE
ALREADY HAVE ESTABLISHED A WELL
BUILT STRUCTURE AND THE CURRENT
FUNDING LEVEL IS 4.7 MILLION APE
YEAR AND YOU CAN SEE AT THE
BOTTOM HALF OF THE SLIDE MOST OF
THE 3.7 MILLION AND COVERS THE
COST OF THE PROCUREMENT AND
DISTRIBUTION OF SAME POLLS AND
THE REST IS USED FOR FUNCTIONS
THAT SUPPORT THE OPERATIONS AND
INCLUDING COORDINATION AND LOCAL
ID.
SO WE ARE QUESTIONING
6.2 MILLION A YEAR WITH
31 MILLION FOR FIVE YEARS FOR
SIX AWARDS AND IT'S JUSTIFIED BY
THE FACT THAT THERE'S BEEN
SIGNIFICANT INCREASE IN DEMAND
FOR MORE LABOR INTENSIVE
SAMPLES.
AND FRESH SAMPLES WHICH ARE
ACTUALLY THE MOST LABOR
INTENSIVE INCREASED DURING THE
FIVE YEARS 33% REQUESTS
INCLUDING CHART REVIEWS
INCREASED FROM 11% TO 16% OF ALL
THE REQUESTS.
THERE WAS A THREE-FOLD INCREASE
IN OTHER MORE DIFFICULT TO
FULFILL REQUESTS SUCH AS SHORT
ISCHEMIA TIME, FOR LABOR DATA,
AND HIGHER HUMOR CONTENT.
THERE WAS A TWO-FOLD IN THE
AMOUNT OF TMAs AND THE DEMANDS
FOR PROCUREMENT OF BLOOD
INCREASED IN COMPLEXITY AND
CTDNA AND CTCs TRIED TO.
SO OUR MAIN GOAL CONTINUES TO BE
TO SUPPLY THE ENTIRE RESEARCH
COMMUNITY WITH HIGH-QUALITY
SAMPLES.
GREAT, THANK YOU, VERY MUCH.
EXCELLENT PRESENTATION.
WE'LL GET STARTED ON THE
DISCUSSION.
>> YES.
SO SUZIE AND NELLY AND I MET
WITH EACH AND THAT WAS RODRIGO
AND AUDRYNA.
THERE WAS A VERY GOOD AND
THOROUGH -TZ OUTSIDE REVIEW THAT
WAS DONE THAT WAS LED BY Dr.
HOLLINGSWORTH AND WE TALKED
ABOUT A NUMBER OF ASPECTS.
WE HAD A NUMBER OF QUESTIONS
THAT WERE RAISED.
ONE OF THE MAJOR QUESTIONS WAS
YES, THIS IS DEIDENTIFIED DATA
SO WE HAD MADE ONE STRONG
SUGGESTION THAT THE RFA ACTUALLY
INCLUDED THAT THAT WOULD BE PART
OF WHAT WAS NEEDED.
THE FEELING WAS THERE'S A LOT OF
GOOD DATA THAT HAS BEEN HAD A
NUMBER OF ACADEMIC INSTITUTIONS,
I BELIEVE IT'S BETWEEN THREE AND
400 EACH YEAR.
YOU AWE 18 HUP INVESTIGATORS SO.
ONE OF THE QUESTIONS IS THE COST
ARE LOW AND WE'RE ALL WORRIED
ABOUT COST THESE DAYS.
THERE IT SHOULD BE LOOKED AT AND
THERE DOING THINGS THAT I DON'T
KNOW EXACTLY BUT THERE SHOULD BE
THE INDUSTRY THAT USES THIS HAVE
HAVE A LARGER PORTION OF THE
COST AND THEN WE WERE A
LITTLE -- THE GEOGRAPHIC
DISTRIBUTION IF APPROXIMATE THE
MATH IS TOTAL BUT ALL OF THE
INSTITUTIONS ARE EAST OF THE
MISSISSIPPI AND THE QUESTION IS
HOW EFFECTIVE ARE WE AT
DEVELOPING SAMPLING FROM A
EXPANDED GEOGRAPHICAL AREA.
THERE ARE PARTNERS FOR EACH ONE
OF THESE GROUPS AND WE DIDN'T
REALLY KNOW HOW WELL THAT WAS
BEING EFFECTED.
SO, WE DID FEEL THAT THE FOCUS
ON FRESH AND FROZEN SAMPLES WAS
PARTICULARLY APPROPRIATE.
MOST PEOPLE HAVE ACCESS TO FIXED
TISSUE SO WE THOUGHT IT WELCOME
BACK EMPHASIZED MORE IN THE RFA.
THOSE WERE MAJOR POINTS BUT I
THINK NELLY MAY HAVE HAD SOME
OTHER COMMUNITIES TOO THAT I
HAVE MISSED.
>> WELL, THANK YOU.
I THINK THERE'S A LOT THAT IS
VERY, VERY IMPORTANT ABOUT
BIOBANKING AND IT'S EXTREMELY
IMPORTANT FOR SUPPORTING RO1
TYPE OF RESEARCH AND WE HAD SOME
REALLY GOOD CONVERSATIONS
LOOKING ALSO AT HOW IS THE USE
DEVELOPED OVER TIME AND WHAT IS
REALLY PERHAPS THE GREATEST NEED
FOR THIS RESOURCE AND YEAH, I
THINK IT'S IMPORTANT TO CONSIDER
WHICH THOUGHT FOR AN INCREASE IN
THE BUDGET, THERE IS DEFINITELY
A POTENTIAL TO CONSIDER THE FEE
SCHEDULE FURTHER AND HOWEVER
THEY ALREADY ADAPTED THAT
SOMEWHAT AND I THINK THAT'S VERY
HELPFUL.
AND YOU KNOW, MAYBE SOME
STRATEGIC PLANNING WOULD BE
HELPFUL FOR THE FUTURE OF
THINKING HOW COULD THIS BESTFUL
FIST IN THE SCOPE OF OTHER BIO
REPOSITORIES THAT EXIST AND I
THINK OF THERE'S NO COMMERCIAL
SUPPORTED BUT FIXED TISSUE ARE
MORE EASILY AVAILABLE THESE DAYS
AND I THINK THAT THIS EMPHASIZE
ON FRESH FROZEN AND OTHER
SAMPLES THAT ARE REALLY
DIFFICULT TO OBTAIN SOMETHING
WHERE THERE'S A UNIQUE NICHE FOR
THIS RESOURCE.
SO, THERE WAS ALSO MENTIONED OF
INCREASING DIGITAL PATHOLOGY
WHICH THE PRIOR REVIEWERS LIKED
AND THOUGHT IT WOULD BE HELPFUL.
THERE WERE SOME PLANS OF
ADDITIONAL FOLLOW-UP IN CHART
OBSTRUCTION BY THE PRIOR
REVIEWERS THOUGHT IT WAS NOT THE
BEST USE OF MONEY FOR THIS NEXT
RFA SO OVER ALL, ALSO, I DON'T
WANT TO SAY I'VE BEEN IMPRESSED
THAT THIS RESOURCE HAS BEEN
REALLY ABLE TO SERVE THE BROADER
COMMUNITY ABOUT 40% OF THE
CURRENT USE IS GOING TO THE
INSTITUTIONS THAT HOLD ONE OF
THESE GRANTS BUT 60% DON'T AND
MAYBE FURTHER ADVERTISING AND
MAKING THIS KNOWN VERY WELL, NOT
JUST ON THE WEBSITE, WILL HELP
TO MAKE SURE THAT IT CONTINUES
AS A VERY IMPORTANT RESOURCE.
SO, OFFER ALL WE REALLY
APPRECIATE THE RESPONSIVENESS
AND THE PROVISION OF EXTRA DATA.
WE DO FEEL LIKE DIVERSITY IN
REPRESENTATIVENESS IS IMPORTANT
AND THAT WAS NOT SOMETHING YET
CONSIDERED.
>> THANK YOU.
ANY FURTHER DISCUSSION?
GO AHEAD, MARC.
>> I MIGHT HAVE MISSED IT BUT IN
TERMS OF THE REQUEST FOR
INCREASING THE BUDGET, IT A
PREPORTION AIM CREASE OR IS
THERE MORE EFFICIENCY GAINED AND
MOST OF THAT BUDGET GOES INTO
TISSUE ACQUISITION OR HOW DOES
THAT PLAY OUT?
IN TERMS OF THAT INCREASE.
ADMIN COST VERSUS SPECIMEN?
>> THE PROCUREMENT AND LABOR TO
DISTRIBUTE THE SPECIMENS, YEAH.
>> MAYBE WE COULD ADD AT THIS
POINT THERE'S AN EQUAL FEE FOR
FIXED ISSUE VERSUS FRESH FROZEN
TISSUE SO THAT WOULD BE AN
OPPORTUNITY TO CONSIDER IF THERE
IS A GREATER WORKLOAD INVOLVED
TO, YOU KNOW, NOT TO MICRO
MANAGE THIS OF COURSE.
>> I'M UNCLEAR, IS THIS JUST
STANDARD TISSUE BANKING?
YOU KNOW, AMONG PATIENTS WHO
GETS NIPPING REMOVED DURING
CLINICAL CARE?
OR IS THERE ANY OTHER CRITERIA
THAT ARE PUT ON WHAT TISSUE IS
COLLECTED, TISSUE OR BLOOD IT
SOUNDS LIKE?
>> IN THIS SIX PRIMARY
INSTITUTIONS, ANY OF SURGERY
THAT GENERATES IS CONSIDERED, A
CANDIDATE TO BE A SAMPLE AND ARE
STORED BECAUSE MOST OF THE MOST
IS PROTUREMENT.
>> THANK YOU.
>> NO OTHER HANDS.
WE CAN MOVE TO VOTING.
SO, SHELLY IT SOUNDS LIKE YOU
ARE IN A FAVORABLE DIRECTION,
WOULD YOU LIKE TO MAKE A MOTION?
>> YES, I WOULD LIKE TO MAKE A
MOTION TO APPROVE.
PARTICULARLY WITH THE ADDITION
OF.
>> I'M TRANSLATE THAT INTO A
MOTION TO CONCUR SINCE THIS IS A
REISSUANCE.
>> CAN I GET A SECOND ON THAT?
>> ANY FURTHER AND HE?
>> OTHER OF HE DIDN'T JOIN THE
IN-PERSON AND WHO HAD A CONFLICT
AND.
>> L YOU HAVE THE FIVE
EXTENSIONS I GATHER.
>> YES, I'LL ALL THEIR NAMES.
>> WHO HAVE OBTAINED.
SO THE VOTE IS 21 CONCUR AND
ZERO NAYs AND FIVE
ABSTENTIONS.
>> Dr. Flaherty: GREAT.
THANK YOU.
ONE MORE CONCEPT A NEW RFP.
AND SBIR CONTRACT TOPICS AND
Dr. MONDAY E MONIQUE POND WILL T
AND SUPPORTED BY MYSELF AND
DAVID ALL OF WHOM WERE ALL
PRESENT FOR THE DISCUSSION WHEN
THE TIME COMES.
SO, MO MONIQUE, GO AHEAD WITH YR
PRESENTATION.
>> GOOD AFTERNOON, EVERYONE,
THANK YOU FOR YOUR TIME.
I'LL BE PRESENTING THE SBIR
TOPICS FOR FY2024 ON BEHALF OF
OUR OFFICE.
AND STTR PROGRAM IS CONGRESS
LEHMAN DATING SET ASIDE THAT IS
REQUIRED BY FEDERAL AGENCY
THAT'S HAVE RND BUDGETS THAT
EXCEED A CERTAIN SIZE.
AND HERE AT NCI WE UTILIZE BOTH
OF GRANTS AND CONTRACT
MECHANISMS FOR FUNDING SO IN
FY202222022, 20% WENT TOWARDS.
WE DON'T PRESCRIBE A SET DOLLAR
AMOUNT TO SPEND ON GRANTS FIRST
OF CONTRACTS INSTEAD WE FOCUS ON
FUNDING THE BEST TRANSLATIONAL
SCIENCE AND THAT ARE HELP
PATIENTS WITH CANCER.
WITH THE CONTRACT MECHANISM,
WE'RE ABLE TO DEFINE NARROWLY
FOCUSED TOPICS THAT HAVE
SPECIFIC PRODUCT DEVELOPMENT
GOALS AND MILESTONES AND THIS IS
IN CONTRAST TO THE GRANTS
MECHANISM WHERE WE FIND
INVESTIGATOR INITIATED PRODUCT
DEVELOPMENT.
AND I JUST WANT TO NOTE HERE
THAT THE MONEY USED TO FUND
THESE SMALL BUSINESS AWARDS,
EITHER THROUGH GRANTS OR
CONTRACTS, DOES NOT EFFECT THE
RPG POOL.
>> SOMETIMES TOPICS DEVELOP TO
ADDRESS A SPECIFIC NEED BY THE
CANCER COMMUNITY AND WE
STIMULATE COMMERCIALIZATION OF
PRODUCTS IN CERTAIN AREAS AND
THIS WOULD BE A RELATIVELY NEW
AREA OF RESEARCH WHERE WE WANT
TO STIMULATE TRANSLATION OF
SCIENCE INTO PRODUCTS FOR
PATIENTS AND OR IT COULD BE TO
SUPPORT DEVELOPMENT OF PRODUCTS
THAT IS A PARTICULARLY
CHALLENGING AREA OF HIGH IMAGE.
LASTLY WE USED THE CONTRACT
MECHANISM TO ADDRESS IMPORTANT
CANCER INDICATIONS OR PATIENT
POPULATIONS UNDER REPRESENTED IN
OUR PORTFOLIO.
SO SIMILAR TO THE GRANT
APPLICATION CONTRACT PROPOSALS
UNDER GO A RIGOROUS PEER REVIEW
PROCESS.
ONE MAIN DIFFERENCE IS CONTRACT
REVIEWS ARE CONDUCTED BY THE NCI
DIVISION OF EXTRAMURAL
ACTIVITIES INSTEAD OF NIH CENTER
FOR SCIENTIFIC REVIEW.
IN ADDITION, CONTRACT PROPOSALS
IN ORDER TO BE SUCCESSFUL, THEY
REALLY MUST ALIGN WITH THIS
SPECIFIC TOPIC AS WELL AS THE
DELIVERABLES THAT ARE DETAILED
IN THE SOLICITATION.
SO, WHILE WE PROVIDE AND YOU
PROBABLY NOTICED IN THE WRITE
UPS WE HAVE AN ESTIMATE OF THE
NUMBER OF PROPOSALS THAT WE
MIGHT FUND UNDER A IT PARTICULAR
TOPIC THEY HELP US WITH BUDGET
PLANNING.
IF WE DON'T RECEIVE ANY STRONG
PROPOSALS FOR A PARTICULAR
CONTRACT TOPIC, WE WON'T FUND
ANY PROPOSALS UNDER THAT TOPIC
AND THE BUDGETED FUNDING WILL
JUSTING USED TO SUPPORT
ADDITIONAL MAR TO BE YUS GRANT
APPLICATIONS.
NEXT SLIDE, PLEASE.
BEFORE I PRESENT THE TOPICS I
WOULD JUST LIKE TO GIVE YOU A
SHORT SUMMARY OF OUR PROCESS FOR
CONTRACT TOPIC DEVELOPMENT.
EVERY OCTOBER WE SO MANY IS ITS
NEW CONTRACT TOPIC ITEMS FROM
ACROSS THE NCI DIVISION OFFICES
ASK CENTERS AND WE RECEIVED
THESE NEW TOPICS ITEMS FOR
SUBJECT MATTER EXPERTS THIS
COULD INCLUDE THE NCI DIRECTOR,
DIVISION DIRECTORS, WORD PROGRAM
OFFICERS AS WELL.
BEGINNING THREE YEARS A. WE
STARTED COM AB RATISTART GETTINS
FOR TOPICS AS WELL.
FOR FY2024, WE RECEIVED 18
CONTRACT TOPIC IDEAS COMMISSIONS
AND THAT CAME FROM ACROSS NCI.
AND AS PART OF EACH COMMISSION,
TOPIC AUTHORS DO A PORTFOLIO
ANALYSIS THAT DETAILS BOTH NCI
AND NIH FUNDING IN THAT
PARTICULAR SCIENTIFIC AREA.
AND THIS ALSO INCLUDES FUNDING
THROUGH SBIR OR NON SBIR
MECHANISMS.
THIS MISSION GOES TO OUR
TECHNOLOGY ADVISORY GROUP WHERE
THEY'RE REVIEWED AND DISCUSSED
AND SCORED.
WE HAVE TWO GROUPS, EACH FOCUSED
ON REVIEWING TOPICS AND CERTAIN
SCIENTIFIC AREAS.
TECHNOLOGIES AND WHILE TAG 2
REVIEWS RADIATION THERAPY,
MEDICAL DEVICES AND HEALTH IT
TECHNOLOGIES.
THESE TAGS ARE COMPOSED OF
SUBJECT MATTER EXPERTS IN THE
SPECIFIC AREAS FROM ACROSS NCI
IN ADDITION TO THE PROGRAM
DIRECTORS IN THE SBIR OFFICE.
SO THIS YEAR 11 OF THE 18 TOPICS
WERE SELECTED TO MOVE FORWARD
FOR REVIEW BY OF SCIENTIFIC
PROGRAM LEADS.
BY THE COORDINATING COMMITTEE AS
HAVING MOONSHOT REL CONVENIENCE.
I JUST WANT TO NOTE ADDITIONAL
INFORMATION IS THERE ON EACH
TOPIC IN THE ONE PAGE WRITE-UP.
SO THE FIRST TOPIC FOR
CONSIDERATION IS THE DEVELOPMENT
OF ULTRAFAST DOSE RATE RADIATION
DETECTORS AND SAFETY SYSTEMS FOR
CANCER TREATMENT.
AND THE GOAL OF THIS TOP SICK TO
DEVELOP DEVICE THAT'S CAN
DELIVER TO PATIENTS SAFELY AND
EFFECTIVELY IN A CLINICAL
SETTING AND WITH THIS REQUEST,
WE'RE FOCUSED ON RADIATION
DETECTORS THAT CAN RELIABLY
FUNCTION AT DOSE RATES OF 40 TO
120 PER SECOND AND ALSO INCLUDE
SAFETY SYSTEMS CAPABLE OF
RECORDING DELIVERY AND SHUTTING
OFF DURING SLASH THERAPY IF
NEEDED.
THE PREVIOUSLY FUNDED PROPOSALS
WERE SUCCESSFUL AND LED TO THE
DEVELOPMENT OF TECHNICALLY
SUFFICIENT DETECTORS AND WE LIKE
COMPANIES TO EXPAND POP THESE
DETECTORS TO FULLY DEVELOP THE
SAFETY SYSTEM THAT GO WITH THEM.
SO THESE PRODUCTS WE SEE HAVE
THE POTENTIAL TO SIGNIFICANTLY
DECREASE NORMAL TISSUE TOXICITY
AND THEY MIGHT DELIVER
THERAPEUTIC BENEFITS TO PATIENTS
AVOIDING SOME OF THE SIDE
EFFECTS.
SO NOW I WILL SUMMARIZE SIX
POTENTIAL CONTRACT TOPICS IN THE
AREA OF CLINICAL DIAGNOSTICS AND
MOLECULAR ANALYSIS.
AS A GOAL OF THIS TOPIC,
TECHNOLOGY IS FOR DETECTING
TUMOR DERIVED AND SUPPORT IN
VITRO TECHNOLOGY THAT CAN
ENUMERATE AND IDENTIFY CELL
TYPES.
CURRENTLY THERE ARE VERY FEW
MARKERS AVAILABLE FOR PREDICTING
METASTATIC RISK AND ACCUMULATING
EVIDENCE THAT SUGGEST THAT THESE
CLUSTERS MAY BE AN IMPORTANT
FACTOR AND MAT METASTASIS AND
ASSOCIATED WITH CO PROGRESS FOR
SURVIVAL AND OVER ALL SURVIVAL
OF PATIENTS.
AND PHASE 1, COMPANIES WITH USE
ANIMAL CANCER MODELS TO
DEMONSTRATE USABILITY AND
ACCURACY.
MUCH WE BELIEVE THAT
TECHNOLOGIES THAT COULD STATIC
RISK EARLY ON THEY HAVE THE
POTENTIAL TO FACILITATE PROMPT
INTERVENTIONS AND PARTICULAR
IMPROVE CANCER OUTCOMES.
THE NEXT TOPIC, RAPID AND A
FORWARD ABLE POINT OF CARE
DIAGNOSTIC FOR CERVICAL CANCER
CONTROL.
AIMS TO DEVELOP TESTING AS AN
APPROPRIATE PRICE THAT WILL
ENABLE THE ESTABLISHMENT OF
SELF-TESTING PROGRAMS GLOBALLY.
SO THESE TECHNOLOGIES ARE
CRITICAL COMPONENTS OF THE WORLD
HEALTH ORGANIZATIONS CERVICAL
CANCER ELIMINATION STRATEGY
WHICH IS FOCUSED ON ADDRESSING
HEALTH DISPARITIES AND RESOURCE
SETTINGS AND FOR HPV SCREENING.
AND WHILE SOME PLATFORMS HAVE
BEEN DEVELOPED FOR HPV TESTING,
THERE'S STILL REMAI REMAINS A NR
RAPID POINT OF CARE TESTING
CAPABILITIES SO IN ORDER TO
FOCUS NCI RESOURCES ON
TECHNOLOGIES THAT ARE FURTHER
ALONG IN DEVELOPMENT, IT COULD
BE MODIFIED TO MEET THESE NEEDS
AND THIN COMMERCIALIZE RAPIDLY
AND THIS TOPIC WILL ONLY HAVE
(INAUDIBLE) TO THESE TWO
PROPOSALS.
THE NEXT TOPIC IS THE
TRANSLATION OF NOVEL CANCER
SPECIFIC AND TECHNIQUES TO
MEDIATE SUCCESSFUL IMAGE GUIDED
NERVE.
AND THE GOAL HERE IS TO DEVELOP
TECHNOLOGIES THAT ARE CAPABLE OF
DETECTING VERY SMALL TUMOR CELL
CLUSTERS IN HUMANS USING
IMAGING.
AND THIS IS A REISSUED TOPIC.
AND THE FOCUS HERE ON THE
REISSUE IS CLINICAL TRANSLATION
AND VALIDATION AND PREVIOUS
DEVELOPMENTAL SUCCESSES WITH
ACTIVATE ABLE DIAGNOSE TICK
APPROACH.
SO PART OF THE PHASE 1 DELIVER
ABLES, COMPANIES ARE REQUIRED TO
VALIDATE THE SENSITIVITY AND
SPECIFICITY OTHER TECHNOLOGY
ANIMAL CANCER MODELS AND OBTAIN
IRB APPROVAL DURING DAY TWO,
COMPANIES WILL BE REQUIRED TO
CONDUCT A DOSE SOH AND SAFETY
STUDY FOLLOWED BY VALIDATION
STUDY IN HUMANS IN THE CANCER
INDICATION OR INDICATIONS.
THE NEXT TOPIC IS THE
DEVELOPMENT OF MICROBIOME BASED
TESTS FOR CANCER RESEARCH
DIAGNOSIS PROGNOSIS OR PATIENT
MANAGEMENT.
LAST YEAR THE MICROBIOME WAS ADD
TO THE LIST OF CANCER HALLMARKS
AND IN ROW SEPTE RECENT YEARS, L
STUDIES HAVE REVEALED THAT
ASSOCIATION OF SPECIFIC HIGH
ROWE BIOME SIGNATURES WITH THEIR
CANCER AS WELL AS THERAPIES.
SO PRODUCTS THAT ARE DEVELOPED
UNDER THIS TOPIC COULD BE ASSAYS
IN THE FORMS OF KITS OR SERVICE
TO DETECT MICRO BIO SIGNATURES
RELATED TO CANCER AND THESE
TECHNOLOGIES WOULD BE CAPABLE OF
USING WITH BIOPSIES AND IT CAN
BE FASTER, SAFER AND MORE COST
EFFECTIVE TO OBTAIN THAN
BIOPSIES AND PARTICULARLY FOR
CANCERS AND TUMORS THAT ARE
DIFFICULT T TO ACCESS.
THE NEXT TOPIC IS THE
DEVELOPMENT OF ORGAN FOR
PRECLINICAL AND TRANSLATIONAL
RADIOLOGICAL STUDIES.
AND WITH THIS NEW TOPIC, WE
WOULD LIKE COMPANIES TO BUILD
UPON WORK DONE IN THE SPACE AND
VALIDATE THESE DEVICES IN ANIMAL
CANCEL MODELS AND THE FOCUS
SHOULD BE DEVELOPING A PRODUCT
THAT ENABLES RESEARCHERS IN
INDUSTRY SETTINGS TO CONDUCT
STUDIES WITH RADIATION ALONE AS
WELL AS SINGLE COMBINATION ALONG
WITH OTHERS.
SO THESE PRODUCTS THAT WE FEEL
COULD ACCELERATE PROGRESS IN THE
RADIO THERAPY MARKET BY
IMPROVING THE ABILITY TO PREDICT
EFFICACY AND TOXICITY OF DRUG
RADIATION COMBINATION AS WELL
THE POTENTIAL TO DECREASE THE
COSTS OF PRECLINICAL RESEARCH
WITH THERAPEUTICS.
SO LAST TOPIC UNDER CLINICAL
DIAGNOSTICS AND MOL IKE LAR
ANALYSIS IS POINT OF CARE
DETECTION OF PROSTATE SPECIFIC
ANTIGENS.
AND THE GOAL HERE IS TO DEVELOP
AND VALIDATE A RAPID LOW COST,
USER FRIENDLY, AND EQUIPMENT
FREE POINT OF CARE TEST FOR PSA
THAT REQUIRES ONLY THE USE OF
BLOOD VIA A FINGER STICK.
CURRENT TESTS AVAILABLE AND
EITHER THEY REQUIRE SAMPLES THAT
NEED TO BE MAILED TO A CENTRAL
LAB OR THEY ARE AT A PRICE POINT
THAT IT'S NOT AFFORDABLE FOR
FULL ADOPTION OR THEY PROVIDE
LESS THAN IDEAL READOUTS FOR
PATIENTS AS WELL.
SO THE AIM HERE IS THAT PRODUCTS
WILL BE DEVELOPED THAT WILL
REDUCE BARRIERS TO TESTING
ESPECIALLY FOR AFRICAN AMERICAN
MEN WHO MAY BENEFIT FROM PSA
SCREENING AND THE ADDRESS OF
SIGNIFICANT CANCER HEALTH
DISPARITY.
NOW I'LL HIGHLIGHT FOUR TOPICS
THAT WE HAVE RELATED TO
INFORMATION TECHNOLOGY AND BIO
INFORMATICS AND THE FIRST IS
CANCER REPRESSION AND TREATMENTS
-- I BELIEVE WE'RE ALLFAMILIARF
RECRUITMENT FROM CERTAIN
COMMUNITIES AND AREAS OF THE
COUNTRY AND THIS IS WELL
DOCUMENTS AND WE HOPE IT
SUPPORTS PRODUCTS THAT ADDRESS
THESE ISSUES AND PROMOTE THE
ENGAGEMENT OF ALL PATIENTS WITH
CANCER AND CLINICAL TRIALS.
THE NEXT TOPIC IS CLOUD BASED
MULTI MODAL SOFTWARE FOR THE
CANCER RESEARCH DATA COMMONS.
AND OUR COLLEAGUES IDENTIFIED
UNMET CHALLENGES WITH BIG DATA
APPAL SIS THAT STILL EXIST AND
SO SPECIFICALLY AN AREA
ANALYTICAL TOOLS THAT CAN
INTEGRATE WITH MULTI MODAL DATA
AND WE'VE ADD DETAILS TO THE
SOLICITATION THAT HIGHLIGHTS THE
GAPS AND DATA ANALYSIS AND THIS
IS NOT AN AREA WHERE WE RECEIVED
MANY APPLICATIONS THROUGH OUR
INVESTIGATOR INITIATED OMNIBUS
GRANT MECHANISMS SO FUNDING
THROUGH THIS TOPIC IS IMPORTANT
TONE ABLE THE CRDC RESOURCE AND
BE LEVERAGED BY THE CANCER
RESEARCH COMMUNITY.
NEXT SLIDE, PLEASE.
CAN YOU ABOUT BACK ONE SLIDE,
PLEASE?
THE NEXT IS EVALUATION DATASETS
AS MEDICAL DEVELOPMENT TOOLS FOR
TESTING CANCER TECHNOLOGIES AND
THE GOAL HERE IS TO DEVELOP
DATASETS THAT CAN BE USED TO
ASSESS MEDICAL DEVICES AND
ONCOLOGY SETTINGS.
AND I JUST WANT TO HIGHLIGHT
HERE THAT THIS TOPIC WAS
DEVELOPED IN COLLABORATION WITH
COLLEAGUES AT THE FDA AND HAS
THE ADDITIONAL GOAL OF
SIMULATING PATIENTS OF SMALL
BUSINESSES AND THE FKA'S MEDICAL
DEVICE DEVELOPMENT TOOL PROGRAM.
THIS PROGRAM IS A MECHANISM THAT
FDA OTHERS TO QUALIFY TOOLS THAT
CAN FACILITATE THE REGULATORY
DECISION-MAKING WHEN EVALUATING
A MEDICAL DEVICE.
THIS PROGRAM WE BELIEVE BENEFITS
NCI FUNDED COMPANIES BECAUSE
THESE FDA QUALIFIED TOOLS WITH
TO OTHER ENTREPRENEURS WHO ARE
DEVELOPING NEW TECHNOLOGIES AND
OR USED TO EVALUATE THEIR
EXISTING TECHNOLOGIES AND THE
TOTAL PRODUCT LIFE CYCLE AND
THIS REALLY PROVIDES A REVENUE
STREAM FOR THIS SMALL BUSINESS
THAT ORIGINALLY DEVELOPED THE
TOOLS.
IN ADDITION, OTHER COMPANIES AND
THIS INCLUDES OTHER NCI FUNDED
SMALL BUSINESSES THAT USE THE
TOOL, TO EVALUATE THEIR NEW
TECHNOLOGIES ARE ABLE TO SPEED
UP THE FDA REGULATORY REVIEW
PROCESS AND POTENTIALLY SHORTEN
THEIR OVER ALL DEVICE
DEVELOPMENT TIMES.
AND THIS IS A REISSUE TOPIC AND
WE RECEIVED PROPOSALS PREVIOUSLY
BUT WE DID NOT FUND THEM BECAUSE
THEY WEREN'T WHAT WE WERE
LOOKING FOR.
SO WE'VE ADDED DETAILS AND
EXAMPLES OF PRODUCTS TO THE
REISSUE SOLICITATION THAT WILL
FACILITATE MORE RESPONSIVE
PROPOSALS AND WE THINK THIS IS
AN IMPORTANT AREA FOR NIH TO
FUND BECAUSE IT'S A SIGNIFICANT
NEED WE SEE IN THE ONCOLOGY
MEDICAL DEVICE COMMUNITY AS WELL
AS THE GAP CURRENTLY IN OUR
PORTFOLIO.
THE LAST TOPIC FOR YOUR
CONSIDERATION IS AUTOMATED
SOFTWARE FOR POINT OF CARE
TESTING TO IDENTIFY CANCER
ASSOCIATED NON NUTRITION.
AND THE GOAL HERE IS TO DEVELOP
A NUTRITION SCREENERS THAT CAN
DEPICT MALNUTRITION EARLY ON AS
WELL AS CANCER CARE PARTICULARLY
IN CANCER POPULATIONS WITH
HIGHER PREVALENCE OF NON
NUTRITION.
AND NUTRITION RISK.
THIS CONTRACT TOPIC WILL SUPPORT
PRODUCT DEVELOPMENT THAT
UTILIZES EITHER EXISTING
NUTRITION SCREENERS AS WELL AS
COUPLING THIS WITH SEGMENTATION
WITH DIAGNOSTIC IMAGING FROM CT
AND MRI.
NEXT SLIDE, PLEASE.
SO I WOULD JUST LIKE TO END
TODAY BY EMPHASIZING THE SIBR
CONTRACT MECHANISM HAS SUPPORTED
THE SUCCESSFUL COMMERCIALIZATION
OF MANY PRODUCTS THAT ARE USED
FOR DIAGNOSING OR TREATING
PATIENTS WITH CANCER AND HERE IS
A SAMPLE, A SIDE PRODUCT FROM
ACROSS DIFFERENT TECHNOLOGIES
AREAS AND FROM 2013 TO 2018 WE
FOUND THAT 20% OF FUNDED
PROJECTS HAVE RESULTED ALREADY
AND COMMERCIALIZED PRODUCTS.
AND WHEN WE LOOK THE THE EARLIER
YEARS, WHEN WE GOT TO 2013 THIS
INCREASES TO JUST OVER 30% OF
CONTRACT FUNDED PROJECTS THAT
HAVE RESULTED IN COMMERCIALIZED
PROJECTS.
AND THIS WAS SIMILAR TO WHAT WE
HAVE SEEN IN OUR GRANTS
PORTFOLIO.
SO, YOU KNOW, WE CONSIDER
CONTRACTS TO BE A VERY IMPORTANT
MECHANISM AND FOR NCI FUNDING
AND IT'S A WAY THAT WE CAN
REALLY SUPPORT INNOVATIVE
PRODUCTS, GETTING TO THE CLIP I
CANCLINICFOR PATIENTS WITH CANC.
THANK YOU FOR YOUR TIME AND I'M
HAPPY TO TAKE ANY QUESTIONS
TODAY.
>> Dr. Flaherty: THANK YOU, VERY
MUCH.
KAREN.
>> THANK YOU, Dr. POND FOR
SUCH A THOUGHTFUL PRESENTATION.
YOU KNOW, I WAS CHAIRING THIS
REVIEW PANEL ALONG WITH Dr.
FLAHERTY AND WE HAD NOTHING BUT
ENTHUSIASM FOR THE SBIR PROCESS
AND WE VERY MUCH APPRECIATED THE
WE WANT IT CARRIED FORWARD FROM
THE NCI.
OUR QUESTIONS ARE WITH Dr.
POND AT OUR FIRST MEETING
AROUNDS TWO YEARS, ONE IS ON
PROCESS.
SO HOW DOES THE DECISIONS THAT
WERE MADE CIRCLE THE TOPIC
AREAS?
WHAT MADE IT THROUGH THAT FILTER
AND WHAT WAS LEFT ON THE CUTTING
ROOM FLOOR, IF YOU WILL AND
TRYING TO UNDERSTAND HOW THOSE
PRIORITIES WERE MADE SO WE HAD A
GOOD DISCUSSION ABOUT THE THINGS
THAT WERE REFLECTED NOW IN THIS
MODIFIED PRESENTATION, YOU KNOW,
WHAT OTHER AGENCIES WERE
INVOLVED AND HOW THE CALLS WERE
PREPARED AND HOW THE GROUP VIEWS
PREDICTING THE NUMBER OF AWARDS
AND A CERTAIN AREA THAT MAY COME
TO PASS SO YOU REALLY FELT VERY
COMFORTABLE WITH THOSE ANSWERS
AND SECOND AREA THAT WE FOCUSED
ON WAS HOW THIS RELATES TO
SIMILAR TYPES OF MECHANISMS AS
SBIR-LIKE MECHANISMS ACROSS THE
NIH AND WAS THERE COR DIN
SITUATION AND WHAT WE CAME TO
LEARN WERE SOME OF THE DIS FINK,
YES, THERE IS.
EX ALSO TO LEARN ABOUT THE NCI
VERSION OF THE SBIR PROGRAM
WHICH YOU HEARD ABOUT.
SO I THINK THERE WAS WIDESPREAD
ENTHUSIASM FOR THIS CONCEPT AND
I WILL TURN IT OVER TO Dr.
FLAHERTY TO SEE IF I'VE BEEN
COMPREHENSIVE IN MY REVIEW.
>> Dr. Flaherty: THANK YOU,
KAREN.
DAVID.
>> SO I THINK OVER THE YEARS
I'VE HAD THE OPPORTUNITY TO
REVEAL ALMOST ALL ASPECT
APPROXIMATES OF THE SBIR PROGRAM
AND I'M VERY CLEAR THAT IT
PRODUCES A TREMENDOUS AMOUNT OF
INNOVATION OVER ALL AND I THINK
THE QUESTIONS RELATED HERE AS
YOU SAID WERE MORE TO THE ISSUE
OF WHAT IS THE CONTRACT
MECHANISM OF WHAT GAP IT FILLS
AND I FEEL CONVINCED THAT THE
PROCESS WAS BOTH COMPREHENSIVE
AND IMPORTANT IN TERMS OF HOW
TOPICS WERE SELECTED.
AND I FOCUSED ON THE
DELIVERABLES BECAUSE IT'S
IMPORTANT TO SEE EXACTLY WHAT
HAPPENED WITH CONTRACTS VERSUS
THE COMPETITIVE PROGRAM AND THE
WIDESPREAD COMPETITIVE PROGRAM
AND THAT DELIVERABLES ON BOTH
SIDES ARE ACTUALLY QUITE
IMPRESSIVE.
REACHING 30% COMMERCIALIZATION
IS I AM PROSE I HAVE AND SO I'M
SUPPORTING AND CONTINUING IT.
>> THIS IS THE MOST COMPLEX
PORTFOLIO ANALYSIS THAT IS TAKEN
WHICH IS WHERE WE CENTERED MUCH
OF OUR CONVERSATIONS.
IT CAME AWAY COMFORTABLE THAT
VERY IMPRESSIVE REPERTOIRE FOR A
DEEP DIVE ANNAL IS SIS OF WHAT
ELSE THE NCI IS SUPPORTING.
ANY A FURTHER DISCUSSION?
I CAN'T HEAR YOU.
>> WE LOST YOU AGAIN.
>> SO THIS IS EXCITE TO GO SEE
AND I JUST CUT TO THE CHASE.
--
>> CAN YOU GET CLOSER TO THE
MIC.
>> I AM CLOSE.
LET ME SEE.
IS THERE SOMEONE ELSE WHO WANTS
TO SAY --
>> NO.
JUST GET A LITTLE BIT CLOSER AND
WE CAN HEAR YOU.
>> IS THIS GOOD?
>> IT'S EXCITING.
COMPREHENSIVE EX COMPLEX.
A COUPLE OF QUESTIONS AND ONE IS
LOOKING AT THE PORTFOLIO AND
LOOKING INTO THE FUTURE A POINT
OF CARE TESTING IS GREAT BUT
WHAT ABOUT HOME TESTING
TECHNOLOGIES IF THERE'S IN THE
CARDS IN THE FUTURE AND THE
SECOND QUESTION I HAVE IS WHAT
IS THE PLAN AND THIS CAME BEFORE
US IN THE PAST SO INCREASE
DIVERSITY OF VENDORS AND THAT
CONTRACTORS AND IN THE PROCESS
THAT DO YOU GET VENDORS AND LET
ME SAVE THAT WORD, CONTRACTORS
OR AWARDS TO PROVIDE THAT
DIVERSITY AND I THINK WE WANT TO
SEE IN MANY OF THESE CONDITIONS
THAT EFFECT POPULATIONS
DISPROPORTIONATELY.
SO TWO QUESTIONS.
I'LL ADDRESS YOUR DIVERSITY
QUESTION FIRST.
THE QUESTION FIRST QUESTION, I
COULDN'T HEAR WHICH CONTRACT
TOPIC YOU ARE REFERRING TO YOU
SAID INSTEAD OF POINT OF CARE,
WHAT ABOUT HOME DEVICES?
AND.
>> THAT WAS MORE RATHER THAN TO
ME QUESTION BECAUSE IF WE CAN DO
A SELF TESTING AT HOME,
SELF-SAMPLING AT HOME AND THE
PRACTICE OF TEST IS A GOOD
EXAMPLE.
CAN'T WE DO THE SELF-TESTING
PERHAPS IN THE FUTURE.
>> TO SUGGEST YOUR QUESTION
DIVERSITY IS AN IMPORTANT PART
OF THE SBIR MISSION AND OUR
GOALS AND ONE OF THE CONTRACT
TOPICS I JUST PRESENTED, THE ONE
ABOUT TOOL DEVELOPMENT FOR
RECRUITMENT AND RETENTION OF
DIVERSE POPULATIONS AND THIS
HIGHLIGHTS ONE OF THE REAL
BENEFITS OF USING A CONTRACT
MECHANISM BECAUSE WE'RE ABLE TO
SPECIFICALLY REQUIRE THE PRODUCT
BE TESTED AND VALIDATED WITH
DIVERSE POPULATIONS.
AND SO THAT IS SOMETHING WE
APPRECIATE FOR THE CONTACT
MECHANISM AND WE FEEL IT BRINGS
REAL VALUE.
THE SECOND POINT IS, YOU KNOW,
OUTSIDE OF CONTRACTS AND WITH
OUR WHOLE PORTFOLIO, DIVERSITY
OF ENTREPRENEURSHIP IS A FOCUS
AND WE HAVE LAUNCHED WHAT WE
CALL OUR AAP, OUR APPLICANT
ASSISTANT PROGRAM AND IN 2019,
IT WAS THE FIRST OF ITS KIND AT
NIH AND THIS WAS A FREE 10-WEEK
PROGRAM TO PEOPLE WHO WERE NEW
TO ENTREPRENEURSHIP TO RECEIVE
MENTORING AND TRAINING AND
PUTTING TOGETHER THE
APPLICATIONS AND OUT OF THIS
PROGRAM, WE'VE HAD NINE COHORTS
THAT HAVE GONE THROUGH THIS
PROGRAM AND IT'S EXPAND TODAY 10
WHICH WE MANAGE ON BEHALF OF ALL
10 AND WE FOUND THAT OF THIS 55
OUT OF THE 63 AWARDS THAT COME
HAVE OUT OF THAT PROGRAM HAVE
BEEN TO UNDER REPRESEN REPRESEND
POPULATIONS SO THIS IS WOMEN AND
INDIVIDUALS FROM RACIAL AND NICK
GROUPS THAT ARE UNDER
REPRESENTED AS WELL AS COMPANIES
LOCATED IN NIDS SPACE.
ON HPV, YOU KNOW, THAT IS A GEE
GOOD QUESTION AND I WILL TURN IT
OVER TO MY COLLEAGUE WHO IS
INVOLVED IN A FEW MORE OF THE
DETAILS OF THIS TOPIC.
>> GREAT QUESTION, I WORKED WITH
THE TEAM FROM DIVISION OF CANCER
PREVENTION ON THIS TOPIC AND
FROM WHAT I UNDERSTAND, THE
TOPIC WE'RE LOOKING FOR
TECHNOLOGIES THAT ARE THE POINT
OF CARE DELIVERY BECAUSE THERE'S
OPPORTUNITIES TO DO RAPID
TESTING AND PROVIDE TREATMENT TO
WOMEN IN NEED SO IT COULD BE A
APARTMENTED FOR HOME USE UNDER
THE RIGHT SITUATION BUT WE'RE
NOT LOOKING FOR THAT.
>> THANK YOU.
>> Dr. Flaherty: SEEING NO OTHER
HANDS.
WE CAN MOVE TO VOTING.
KAREN, WOULD YOU LIKE TO MAKE A
MOTION.
>> I WOULD.
I'D LIKE TO MAKE A MOTION TO
APPROVE.
>> Dr. Flaherty: GREAT.
I WILL NOT BE THE SECONDER SINCE
I'M CHAIRING AND DAVID, WOULD
YOU LIKE TO SECOND THAT.
>> SECOND.
>> THANK YOU.
>> Dr. Flaherty: ANY FURTHER
DISCUSSION?
SO WITH MOTION TO APPROVE,
LOOKING FOR ANY DISAPPROVAL
VOTES.
VOICE OR RAISE OF HAND.
ANY A ABSTENTIONS.
I DON'T HAVE ANY RECORDED IN
ADVANCE.
>> IT'S UNANIMOUS APPROVAL.
>> Dr. Flaherty: EXCELLENT.
WE REACHED THE END OF OUR BRIEF
REVIEW AND I HOPE TO SEE MORE
PROPOSALS IN THE JUNE MEETING AS
I SAID BEFORE.
THANK YOU ALL FOR EXCELLENT
DISCUSSION BOTH IN THE CONCEPTS
AND PRIOR TO THAT TIME.
WE ARE OVER TIME AND OUR AGENDA
AND THE ONLY OTHER AGENDA ITEM
IS ALWAYS WE USUALLY FINISH WITH
ANY NEW BUSINESS PRESSING ISSUES
FOR TODAY'S DISCUSSION AND AS
WELL AS CONSIDERATIONS FOR
FUTURE TOPICS TO DISCUSS AND
FUTURE MEETINGS.
I'LL SUGGEST THAT FOR THE FUTURE
MEETINGS PLEASE REACH OUT TO ME
DIRECTLY AND PAULETTE AND WE
WILL ACCUMULATE SUGGESTIONS IN
TERMS OF FUTURE TOPICS TO ASK
NCI LEADERSHIP TO LIBERATOR ON
WITH US AND ANY OTHER PRESSING
ISSUES FOR TODAY?
>> LOOK FORWARD TO JUNE.
>> Dr. Flaherty: YES, IN-PERSON
IN JUNE.
ALL RIGHT.
EXCELLENT.
THANK YOU, ALL.
APPRECIATE THE PARTICIPATION.
>> THANK YOU.
>> THANK YOU, EVERYONE.
>> BYE.