>>THE WHOLE PREMISE OF THE
MEETING IS HOW CAN WE EDUCATE
PEOPLE TO DO TRANSLATIONAL
RESEARCH BETTER, ACTUALLY
EXPERIENCE FIRST HAND A VARIETY
OF SCENARIOS, FOR INVESTIGATORS,
EVERYTHING FROM THE FACT THAT
THEY LOSE POTENTIAL FOR
COMMERCIALIZATION BECAUSE THEY
DON'T UNDERSTAND THE PROCESS OF
EPITHELIAL LECTUAL PROPERTY AND
HOW THAT NEEDS TO PROCEED TO
JUNIOR INVESTIGATORS WORKING ON
SOMETHING FOR A LONG PERIOD OF
TIME THAT HAS REALLY NO CLINICAL
RELEVANCE.
SO I THOUGHT WE WOULD START OFF
WITH SUMMARIZING, ROSE CAN
BEGIN, WITH THE PREVIOUS SORT OF
UPDATES FROM THIS PARTICULAR
WORKING GROUP.
ROSE, I WILL TURN IT OVER TO YOU
SO THAT YOU CAN COMMENT ON THE
CELLULAR THERAPIES FOR SOLID
TUMORS AS FAR AS THE UPCOMING
RFAs THAT RESULTED FROM THIS
INITIATIVE PREVIOUSLY.
ROSE, DID YOU WANT TO TAKE OVER?
>> I WILL BE HAPPY TO DO THAT,
AND I ALSO WANT TO--I DON'T KNOW
IF WE HAVE NEW MEMBERS TO THE
SUBCOMMITTEE AND I JUST WANT TO
SAY I'M ROSE AURIgE MMA,
WELCOME TO ANY NEW MEMBERS, I
WASN'T SURE IF THEY WANTED TO
INTRODUCE THEMSELVES OR NOT.
I THINK WE HAD 2 NEW MEMBERS.
ARE THERE ANY NEW 1S PRESENT?
NO?
OKAY, THEN WE CAN GO RIGHT ON.
THE RETURN OF MEMBERS.
>> --I THINK I'M NEW TO THE
SUBCOMMITTEE.
>> I'M SORRY,.
>> TOOK ME A MACHINEUTE TO
UNMUTE, THANK YOU.
>> I'M SORRY COULD YOU
REINTRODUCE YOURSELF?
>> SURE, I'M MILO ASSAD, 1 OF
THE NCAB MEMBERS AND I'M FROM
JOHNS HOPKINS.
>> TERRIFIC.
THANK YOU.
ANYBODY ELSE?
IS THAT IT?
OKAY, GREAT.
WELL THE RETURNING MEMBERS ARE
FAMILIAR WITH THIS TOPIC BECAUSE
THE SUBCOMMITTEE CHOSE IT 2
YEARS AGO AT OUR INAUGURAL OR
REINAUGURAL I GUESS CONVENING OF
THE SUBCOMMITTEE, SO IN THAT
TIME, WE HELD SOME--A WORKSHOP
IN DECEMBER OF 2020.
WE PUBLISHED A WHITE PAPER ON
THE SUMMARY OF WHAT WE FOUND
FROM OUR STAKEHOLDERS TO BE
CHALLENGES FOR THE CELL THERAPY
COMMUNITY.
HELLO?
I
>> ROSE, I THINK IT'S
BACKGROUND.
>> OH, OKAY, GREAT.
NEXT SLIDE, PLEASE.
AND THEN NCI EMBARKED ON A
NUMBER OF WAYS TO HELP THE CELL
THERAPY COMMUNITY ESPECIALLY TO
ADVANCE NEW TREATMENTS FOR SOLID
TUMORS.
SO THESE WERE THE OUTCOMES OF
THOSE MEETINGS, THE AREAS OF
UNMET NEED WERE TO HAVE MORE
SUPPORT FOR PRECLINICAL AND
TRANSLATIONAL RESEARCH, TO BE
ABLE TO CONDUCT SMALL PROOF OF
CONSEPTD STUDIES, BECAUSE ANIMAL
STUDIES ARE NOT REALLY FEASIBLE
FOR CELL THERAPIES, TO ENHANCE
CELL MANUFACTURING TECHNOLOGIES,
RIGHT NOW, THEY ARE VERY
CUMBERSOME AND THERE'S HIGHER
THAN ACCEPTABLE FAILURE RATE FOR
MAKING INDIVIDUALIZED CELL
THERAPIES.
WE NEED MORE BIOMARKERS SO THAT
WE CAN UNDERSTAND HOW THE
THERAPIES ARE WORKING AND WHAT
PATIENTS THEY WOULD BENEFIT AND
WE NEED BETTER IMAGING
TECHNIQUES IN ORDER TO TRACK THE
CELL THERAPIES AS WELL AS
UNDERSTAND WHETHER THEY'RE
WORKING.
SO, I JUST WANT TO GET ON TO
WHAT NCI HAS ADDED MOST RECENTLY
BECAUSE I HAD ALREADY PRECEPTED
TO YOU INFORMATION ABOUT HOW WE
HAD EXPANDED OUR MANUFACTURING
SERVICES UP AT OUR FREDERICK
FACILITY, THE BIOPHARMACEUTICAL
DEVELOPMENT PROGRAMS FACILITY
WHERE THEY'RE MANUFACTURING CELL
THERAPIES RIGHT NOW TO SUPPORT 2
DIFFERENT CLINICAL STUDIES.
AND THEN MOST RECENTLY, JUST IN
THE LAST WEEK, WE HAVE
PUBLISHED, 3 RFAs, TO CREATE A
CANCER ADOPTIVE CELL THERAPY
NETWORK OR WHAT WE'RE CALLING
CAN-ACT.
SO THERE IS THIS MECHANISM, IF
YOU GO TO THE NEXT SLIDE, I
BELIEVE, THE WAY IT WORKS IS
THESE ARE UG3, UH3 AWARDS, THE
UG3 PHASE WILL BE THE
PRECLINICAL AND I& D ENABLING
WORK TO SUPPORT NEW CELL THERAPY
DEVELOPMENT AND THEN THE UH3
AWARDS WILL BE FOR OR PHASE OF
THE AWARD WILL BE TO FUND THE
CLINICAL TRIALS.
WE INTEND THESE TO BE VERY
COLLABORATIVE, WE WANT DIFFERENT
CENTERS TO POOL THEIR RESOURCES
AND COLLABORATE SO THAT WE CAN
SUPPORT ALL OF THESE DIFFERENT
AREAS OF NEED, THE IMAGING, THE
BIOMARKERS, THE DEVELOPMENT OF
NEW MANUFACTURING TECHNOLOGIES,
WHATEVER, HOPEFULLY WHEN WE
START GETTING APPLICATIONS, WE
WILL BE GETTING SUCH
COLLABORATIVE EFFORTS.
SO THERE WILL BE A TOTAL OF 7
AWARDS RIGHT THERE IS DEPICTED
FROM 2 ADULT AND 2 PEDIATRIC BUT
WE DO INTEND TO HAVE THEM
HOPEFULLY EVENLY DISTRIBUTED
BETWEEN ADULT AND PEDIATRIC
EFFORTS.
AND THEN, THESE ARE GOING TO BE
SUPPORTED BY AND IN IMMUNE CELL
NETWORK CORE, THIS IS THE
FREDERICK RESOURCES I MENTIONED.
THE FREDERICK NATIONAL LAB
RESOURCES UP IN AT THE PLANT IN
FREDERICK.
SO THERE IS AN INFORMATIONAL WEB
EXPECTATIONS NEXT WEEK,
SEPTEMBER 7th AT 4:00 P.M.,
THE LINK IS THERE AND I CAN SEND
IT TO YOU SEPARATELY IF YOU
LIKE.
WE ARE IN THE PROCESS OF SENDING
E-MAIL NOTIFICATIONS OUT TO
ANYONE THAT WE CAN, ALL OF THE
ATTENDEES FOR OUR CELL THERAPY
WORKSHOPS TO ALL OF OUR GRANTEES
AND OUR PORTFOLIO, TO THE CANCER
CENTER DIRECTORS, TO THE SPORE
PROGRAMS, BASICALLY ANYONE WHO
MAY BE INTERESTED IN
PARTICIPATING IN THIS EFFORT, WE
ARE SENDING INFORMATION OUT.
SO WE'RE LOOKING FORWARD TO
MAKING THESE AWARDS, IN LATE
SPRING, I GUESS BY THE JUNE NCAB
MEETING AND GETTING THIS NETWORK
LAUNCHED.
SO THAT'S ALL I HAVE TO SAY
ABOUT THAT AND THEN, I THINK THE
NEXT SLIDE, BELONGS TO--NEXT
SLIDE.
>> THERE WE GO, YOU ARE UP.
>> OKAY, SO NEXT SLIDE.
OKAY, SO, THE TRADITIONAL MODEL
FOR TRANSLATIONAL RESEARCH HAS
USUALLY BEEN A HANDOFF BETWEEN
ACADEMIC OR GOVERNMENT AND OVER
TO INDUSTRY AND INCREASINGLY
WHAT WE'RE SEEING IS MORE
PARTNERSHIP MODEL ESPECIALLY THE
LAST 10-20 YEARS, WHERE YOU CAN
HAVE THIS INTERFACE VERY EARLY
WITH INDUSTRY AND A PRECLINICAL
MODELING, ET CETERA.
SO I THINK EVERYONE ON THIS CALL
IS PRETTY FAMILIAR WITH THE
RESEARCH STAGING FROM
PRECLINICAL RND THROUGH RND
CLINICAL DATA TRIAL AND
OBVIOUSLY THERE'S A LOT OF SORT
OF INFORMATION AND DATA THAT
NEEDS TO OCCUR AT EACH STEP
ALONG THIS ACTIVITY PIPELINE, SO
YOU KNOW YOU HAVE TARGET
DISCOVERY WHERE YOU HAVE TO HAVE
EXPERTISE IN SCREENING,
STRECTURE, FREQUENCY OF
EXPRESSION OF YOUR TARGET,
MECHANISTIC UNDERSTANDING OF
WHAT YOUR ACTUALLY GOING AFTER,
THEN YOU HAVE DRUGS, SO YOU HAVE
TEST ARTICLES THAT YOU WILL HAVE
TO RUN THROUGH, SCREENING, LEAD
AUTHORIZATION, YOU HAVE TO WORK
ON DELIVERY ROUTE OF
ADMINISTRATION, ET CETERA.
FOR TARGETS THAT ARE LESS
FREQUENT, YOU HAVE TO CONSIDER A
COMPANION BIOMARKER.
YOU ADDITIONALLY HAVE TO
UNDERSTAND THE INDICATION THAT
YOU WANT TO MOVE INTO ESPECIALLY
IF THAT TARGET IS EXPRESSED IN A
VARIETY OF DIFFERENT TYPES OF
MALIGNANCIES.
ONCE YOU DO HAVE A DRUG, YOU
HAVE TO UNDERSTAND THE
PHARMACOLOGY, METABOLISM, PK,
TOXICOLOGY AND ALL OF THIS THEN
NEEDS TO SEGUE INTO AN IND FOR
EVENTUAL IMPLEMENTATION IN A
PHASE 1 CLINICAL TRIAL INCLUDING
THINGS LIKE SAFETY, DOSE, AND
SIGNAL RESPONSE.
AND CLINICAL TRIAL, YOU KNOW
DESIGNS ARE INCREASINGLY BECOMES
A BIT MORE COMPLEX, INCLUDING
THINGS LIKE ADAPTIVE BASIAN
CLINICAL TRIAL DESIGN, THE
SEAMLESS 1-3 TRANSITIONS AND
THEN ALSO WIND O OF OPPORTUNITY
STUDIES THAT ARE BEING FORWARDED
BETWEEN PHASE 1 AND 2 CLINICAL
TRIALS TO LOOK TO SEE IF THERE'S
ENGAGEMENT TO THE TARGET PRIOR
TO MAKING DEFINITIVE STEPS
TOWARDS LATER STAGE CLINICAL
TRIALS.
SO THIS OBVIOUSLY INCLUDES A
LEVEL OF RIGOR.
IT ALSO REQUIRES A VERY DIVERSE
AREAS OF EXPERTISE IN ORDER TO
MOVE ALONG THIS PIPELINE.
AND I THINK WE'RE ALL VERY MUCH
AWARE OF THE VALLEY OF DEATH
WHERE QUITE A FEW OF THESE
COMPOUNDS NEVER REALLY SEE THE
LIGHT OF DAY OR THEY MAY BE
BEGIN EARLY PHASE 1 OR 2
CLINICAL TRIAL ONLY TO FAIL AT
LATER STAGE CLINICAL STUDIES.
SO, NEXT SLIDE.
SO, THIS COMES FROM THE FACT
THAT IN ADDITION TO HAVING THE
ABILITY TO DO GOOD QUALITY
SCIENCE, THERE'S OTHER KEY
ELEMENTS THAT A LOT OF
INVESTIGATORS ARE NOT
NECESSARILY FAMILIAR WITH.
I THINK EVERYONE IS VERY MUCH
AWARE OF THE FACT THAT THERE HAS
BEEN ISSUES WITH REPRODUCIBILITY
ESPECIALLY IN BASIC SCIENCE LABS
WHEN PHARMA GETS THEIR HANDS ON
IT, IT'S A CHALLENGE TO
NECESSARILY BE ABLE TO REPRODUCE
THAT DATA FOR A WIDE VARIETY OF
REASONS.
A LOT OF TIMES AN INVESTIGATOR
MAY BE VERY INTERESTED IN A
MECHANISM, BUT NOT NECESSARILY
CONSIDERED THINGS LIKE THE
CLINICAL RELEVANCE AND
INDICATION, MANY TIMES
COMPETITIVE LANDSCAPE IS NOT
CONSIDERED SO THERE'S A LOT OF
EFFORT EXERTED ONLY AGAIN NOT TO
SEE LATER STAGE CLINICAL TRIAL
DEVELOPMENT, ET CETERA.
A LOT OF TIMES INVESTIGATORS
DON'T THINK ABOUT THINGS LIKE
RETURN OPEN OF INVESTMENT FOR
EXAMPLE, IF YOU ARE DOING A
REALLY INTENSIVE G& P PRODUCT
CELLULAR THERAPEUTIC, WHERE IT
REQUIRES A HIGH AMOUNT OF
DOLLARS, A PHARMA COMPANY MAY
NOT NECESSARILY BE INTERESTED IN
MOVING THAT ALONG BECAUSE
THEY'RE NOT ESSENTIALLY GOING TO
GET A RETURN ON INVESTMENT FOR
ACTUALLY IMPLEMENTING THAT IN
LET'S SAY A RARE CANCER SITE,
YOU KNOW INTELLECTUAL PROPERTY
CONSIDERATIONS, YOU HAVE A WHOLE
SLEW OF REGULATORY ISSUES, MANY
PEOPLE ARE NOT NECESSARILY
TRAINED IN THIS, OTHER THAN A
CURSEARY CLINICAL TRIAL OF
COURSE IN THEIR CANCER CENTER,
THERE'S PRIVACY ISSUES AND
OBVIOUSLY THERE'S ALSO FUNDING
ALIGNMENT.
IN OTHER WORDS HOW DO YOU
IDENTIFY WHICH FUNDING SOURCES
YOU MIGHT WANT TO CONSIDER ALONG
THIS CONTINUUM.
THIS IS OBVIOUSLY VERY
CHALLENGING FOR TRANSLATIONAL
RESEARCHERS AND OUR BASIC
SCIENTISTS AND 1 OF THE THINGS
WE'VE BEEN TRYING TO DO IS
TRYING TO HELP GUIDE SOME OF
THESE FOLKS THAT WANT TO DO
THESE KINDS OF TRANSLATIONAL
RESEARCH.
WE'RE SORT OF A METRIC, SO 1
THING WE DEVELOPED AT CANCER, IS
THE PANEL I'M SHOWING ON THE
RIGHT WHERE IT ALLOWS
INVESTIGATORS TO START THINKING
A LITTLE BIT ABOUT HOW AS YOU'RE
DEVELOPING SOMETHING, A DRUG, OR
GOING AFTER A TARGET, HOW THAT
WOULD ACTUALLY PAN OUT IF IT
ACTUALLY PASSED TO PHARMA MPLET
BUT I WILL TELL YOU AS THE
PERSON THAT'S IN CHARGE OF OUR
TRANSLATIONAL BRIDGE PROGRAM
HERE AT THE CANCER CENTER, THIS
WAS REALLY--IT'S BEEN A STEEP
LEARNING CURVE FOR MANY OF THE
INVESTIGATORS AND IT'S BEEN A
LITTLE PAINFUL FOR THEM ACTUALLY
TO UNDERSTAND SOME OF THESE
BASIC CONCEPTS.
SO, AS A TRANSITION, AS I MOVE
FROM 1 CANCER CENTER TO ANOTHER
I NOTICE THE SAME ISSUES WERE
SORT OF EMERGING BETWEEN THESE
VARIOUS CENTERS IN, IN LITTLER
WORDS THIS IS NOT JUST EXCLUSIVE
TO 1 PARTICULAR CENTER, I THINK
IT'S VERY UNIVERSAL AND THE
QUESTION IS, THERE'S A LOT OF
REDUNDANCY, OF SOME OF THE
TEACHING AND SOMETIMES THERE'S
TREMENDOUS GAPS IN THE TEACHING
AT ANY GIVEN CANCER CENTER.
SO NEXT SLIDE.
SO WHAT I WANTED TO DO IS FOR
THIS MEETING TODAY, GO BACK,
THERE SHOULD BE A SLIDE IN
BETWEEN.
OKAY, I'M SORRY, GO FORWARD,
JUST A FEW MORE SLIDES.
SO WHAT WE WANT TO DO, GO
FORWARD 1 MORE, 1 OF THE THINGS
WE WANT TO DO AND I WILL TURN IT
BACK OVER TO ROSE IN JUST A
SECOND, IS WE WANT TO HAVE A
DISCUSSION TODAY WITH REGARDS TO
WHETHER THE NCI CAN SERVE AS A
KEY HUB FOR BASIC TRANSLATION
AND RESEARCH UTILIZING AND
EXPLOITING ELECTRONIC FORMAT SO
WE WANT TO TALK ABOUT WHETHER
THERE'S POETIC TEBTIAL FOR
ARCHIVING A LIBRARY OF TOPICS
FOR RAPID ACCESS, WHETHER WE
NEED TO HARMONIZE THIS KIND OF
TRAINING, WHETHER WE COULD
REDUCE REDUNDANCY IN DEVELOPING
THE CURRICULUM NATIONWIDE, AND
WHETHER WE COULD ACTUALLY FOLD
IN INSTRUCTIONS THAT ARE KEY
LEADERS IN THE WIELD.
I ALSO THINK CANCER CENTERS HAVE
A APPROXIMATE SPECIFIC EXPERTISE
AND A CENTER WHERE A CANCER
CENTER IS GOOD AT NANO
TECHNOLOGY AND HAD IS A DOMAIN I
WOULD NOMINATE OUR CANCER CENTER
FOR AS FAR AS PROVIDING
INSTRUCTION IN DEVELOPING
INTELLECTUAL PROPERTY
SPECIFICALLY IN THIS PARTICULAR
AREA.
I'M WONDERING IF WE CAN USE THE
CURRENT KRIM LUMOFFERRED BY THE
NCI AS A STARTING POINT FOR THIS
INITIATIVE AND THIS IS PART OF
THE REASON WHY WE ASKED
DR. [INDISCERNIBLE] TO PROVIDE
HIS PRESENTATION AND ROSE TO
JUST TO SORT OF EMPHASIZE THE
NEED FOR THIS, GO BACK 2 OR 3
SLIDES, PLEASE?
THERE'S TREMENDOUS DEMAND
THROUGH THE DEVELOPMENTAL
CONSULTATION SERVICE AND I WILL
LET ROSE KIND OF COMMENT ON THIS
REAR FOR THESE PARTICULAR PIECES
OF KNOWLEDGE, SO THIS IS NOT
JUST AT THE CANCER CENTER LEVEL,
THIS IS AT THE NATIONAL LEVEL.
SO ROSE, DID YOU WANT TO COMMENT
A LITTLE BIT ABOUT THIS
CONSULTATION SERVICE?
>> SURE, JUST VERY BRIEFLY.
YOU KNOW HAVING OVERSEEN GRANTS
PORTFOLIOS FOR ALMOST 20 YEARS,
AND WE DO HAVE IN OUR PORTFOLIO
OVER 800 ACTIVE AWARDS THAT ARE
ALL INVOLVING, DISCOVERING
DEVELOPMENT OF NEW THERAPIES.
WE SPEND A LOT OF TIME EDUCATING
OUR INVESTIGATORS ABOUT THE
CRITICAL PATH TO DEVELOP--TO
DISCOVER AND DEVELOP MOLECULES
AND IT JUST IS A CONSTANT
TURNING OVER IN YOU KNOW NEW
INVESTIGATORS WHO NEED TO LEARN
THIS INFORMATION.
SO, WE LAUNCHED SEVERAL YEARS
AGO, THIS PAGE, ACTUALLY IT WAS
ALREADY AVAILABLE BUT WE JUST
BEGAN REALLY ADVERTISING IT AT
AACR AND ASCO AND OTHER VENUES
AND ENCOURAGING ANY OF OUR
INVESTIGATOR WHO IS ARE ENGAGED
IN DISCOVERING DEVELOPMENTAL NEW
THERAPIES TO REQUEST A
CONSULTATION ON DEVELOPMENT AND
IF YOU WILL GO TO THE NEXT, TO
THE NEXT PAGE.
SO THIS IS AVAILABLE FOR ALL
COMERS, IT'S NOT-IT'S NOT JUST
FOR ACADEMEITIONS, IT'S NOT JUST
FOR THOSE WHO HAVE FUNDING, WE
WILL TALK TO PRETTY MUCH ANYBODY
AND IT'S A CONFIDENTIAL
CONSULTATION.
YOU KNOW, THEY CAN SHARE
STRUCTURES WITH US, AND OTHER
INFORMATION AND IT IS HELD
CONFIDENTIAL AS ALL OF OUR GRANT
INFORMATION.
AND WE WILL JUST SEE A BREAK
DOWN OF WHAT OUR USERS HAVE
LOOKED LIKE, SO IT'S LARGELY
ACADEMIC BUT WE DO GET QUITE A
FEW CONSULTATIONS FROM INDUSTRY
AND WE HAVE WORKED WITH THE
SBIRPROGRAM BEFORE TO HAVE JOINT
CONSULTATIONS, AND WE ALSO HAVE
HAD CONSULTATIONS ALL AROUND THE
COUNTRY AS WELL AS AROUND THE
WORLD.
IT'S A CHALLENGE SETTING UP
THOSE CONFERENCE CALLS BUT WE
DO, INTERNATIONALLY, AND THEN
YOU CAN SEE THE TOPICS THAT ARE
REQUESTED, A LOT OF IT IS JUST
THEY PRECLINICAL, CRITICAL PATH
ACTIVITIES THAT FOLKS ARE JUST
NOT AWARE OF WHETHER IT'S
COMMUNICATION WITH THE FDA, YOU
KNOW, WHAT TYPES OF
COMMUNICATIONS AND WHEN THEY
SHOULD BE COMMUNICATING.
WHAT THEIR PRECLINICAL AND
PHARMACOLOGY AND TOXICOLOGY
OUGHT TO LOOK LIKE FOR THE GIVEN
KIND OF THERAPY THEY'RE
DEVELOPING, WHAT SORTS OF TUMOR
MODELS OR PROOF OF CONCEPT THEY
MIGHT NEED AND THEN YOU KNOW,
THINGS LIKE MANUFACTURING AND
SYNTHESIS.
SO, WE ALSO ARE ENGAGED IN THIS
WITH OUR NANO TECHNOLOGY
PARTNERS AND OUR DIVISION AS
WELL AS WITH THE IMAGING FOLKS
IN OUR DIVISION, SO WE DO GET
REQUESTS TO TALK ABOUT IMAGING
AGENTS THAT ARE UNDER
DEVELOPMENT OR NANO TECHNOLOGY
AGENTS.
SO THERE'S A REALLY GREAT NEED.
THEY ARE A LITTLE SHY IN TALKING
WITH US, BUT I THINK A LOT OF IT
HAS TO DO WITH THE FACT THAT
THEY DON'T KNOW WHAT THEY DON'T
KNOW.
SO A LOT OF TIMES THIS IS VERY
ENLIGHTENING FOR INVESTIGATORS,
THEY JUST DON'T--THEY MAY BE
EXPERTS IN CHEMISTRY BUT NOT IN
BIOLOGY, YOU KNOW THEY JUST
DON'T HAVE THE FULL COMPLEMENT
OF KNOWLEDGE IN ORDER TO GET
SOMETHING THROUGH INTO IND.
>> SO WITH THAT, DR. BOGLER'S
SLIDES, PLEASE?
>> YEAH, THANK YOU VERY MUCH.
I THOUGHT IT MIGHT BE HELPFUL TO
SHARE WITH THE COMMITTEE SOME OF
THE ACTIVITIES ALREADY EXTEND AT
THE CENTER FOR CANCER TRAINING
IN THIS SPACE, SO I PREPARED A
VERY SHORT DECK THAT I'M KIND OF
PERHAPS SETS THE LANDSCAPE OF
THE KINDS OF THINGS THAT ARE
ALREADY GOING ON AND THE KINDS
OF EXISTING MECHANISMS THAT
WOULD SUPPORT AN EFFORT LIKE
THIS.
SO ON THE NEXT SLIDE IS AN
INTRAMURAL PROGRAM THAT I THINK
MAY BE THE COMMITTEE IS NOT
AWARE OF.
THIS IS ACTUALLY A PARTNERSHIP
WITH THE FDA THAT WE'VE BEEN
DOING SINCE 2005 WITH THE GOAL
OF BRINGING DISCOVERIES, TO THE
CLINIC MORE QUICKLY AND IT'S A 2
YEAR FELLOWSHIP THAT'S OFFERED
TO PEOPLE BOTH FROM OUR
INTRAMURAL PROGRAM, BUT YOU
DON'T HAVE TO COME FROM THE
NCI'S INTRAMURAL PROGRAM.
THE IDEA IS TO STRAIN SCIENTISTS
IN RESEARCH AND RESEARCH RELATED
REGULATORY AREAS, POLICIES,
REGULATIONS SO THAT THEY REALLY
UNDERSTAND WHAT IT TAKES TO GET
THROUGH AN FDA APPROVAL PROCESS.
AND AS YOU CAN SEE, WE'VE HAD 70
GRADUATES TO DATE FROM THIS
PROGRAM.
MANY OF THEM WORK AT FDA BUT
SOME GO TO INDUSTRY, A HANDFUL
GO TO GOVERNMENT AND ACADEMIA OR
CLINICAL ROLES.
SO, THIS IS CLEARLY A 2 YEAR
IMMERSIVE FELLOWSHIP.
IT'S NOT A SHORT COURSE, IT'S
NOT SOMETHING DELIVERED
ELECTRONICALLY, IT'S QUITE
INTENSE BUT I WANTED TO MENTION
IT BECAUSE I THINK IT'S AN
IMPORTANT CONTRIBUTOR TO THIS
ISSUE.
THE NEXT SLIDE, THEN, SHIFTS TO
EXTRAMURAL AND JUST REMINDS THE
COMMITTEE OF THE OFFERINGS FROM
IN CREATIVE DEVELOPMENT
TRAINING, FELLOWSHIPS AND
EDUCATION FROM THE NCI, NOT JUST
FROM THE CENTER FOR CANCER
TRAINING BUT ALSO FROM THE
CENTER TO REDUCE CANCER HEALTH
DISPARITIES.
I PARTICULARLY POINT OUT THE K08
WHICH IS FOR CLINICIAN
SCIENTISTS AND THE K22 FOR
EMERGING NPTD RESEARCHERS AND
THEN THE 3 AWARDS BELOW THE
GRAPHIC WHICH ARE INSTITUTIONAL
AWARDS, THE T32, K12 AND R25 ALL
OF WHICH HAVE EXAMPLES OF
ENGAGEMENT IN THIS AREA.
THE NEXT SLIDE, THEN, ADDS A
LITTLE DETAIL, THIS IS TO THE
SNAPSHOT OF OUR OFFERINGS, JUST
TO GIVE YOU AN IDEA OF WHERE THE
NUMBERS OF GRANTS FROM US IN
CHCRD AND THE DOLLARS INVESTED
ARE, SO YOU CAN SEE THE
MECHANISM I MENTIONED, THE K08,
THE K12, R25 AND T32, THESE ARE
MAJOR COMPONENT ANDS WE INVEST
HEAVRY IN THIS.
WE ALSO DID A BRIEF SURVEY OF
ACTING GRANTS AND LOOKED AT
PATENTS ASSOCIATED WITH THEM AS
1 MEASURE OF ACTIVITY THAT LEADS
TO THE CLINIC DOESN'T MEAN IT'S
THE THERAPEUTICMENT OF COURSE,
THESE ARE VERY MUCH QUICK LOOKS,
IF THE COMMITTEE DESIRES A MORE
INDEPTH ANALYSIS OF COURSE, WE
WOULD BE HAPPY TO DO THAT AND
PARTICIPATE IN THAT BUT I WANTED
TO GIVE YOU SOMETHING, SO THERE
ARE A HANDFUL OF PATENTS
ASSOCIATED WITH OUR K12
PROGRAMS, R25S AND T32s.
AND THE NEXT SLIDE SHOWS YOU THE
CURRENT K08 PORTFOLIO, SO THESE
ARE THE AWARDS THAT WERE MADE IN
RESPONSE TO THE LAST 3 ROUNDS OF
PROGRAM ANNOUNCEMENTS AND IN
THESE 3 PROGRAM ANNOUNCEMENTS
WE'VE HAD 3 ANNOUNCEMENTS IN
PARALLEL, 1 FOR CLINICAL TRIALS,
1 FOR CLINICAL TRIALS
NONAPOPTOTIC THE ALLOWED, AND
FOR FOR BASIC STUDIES WITH
HUMANS FOR WHICH WE HAVE NO
AWARD.
SO WHAT I'M SHOWING YOU HERE IS
THAT THERE ARE K08S FOCUSED ON
CLINICAL TRIALS IN THE
3--REWARDING A RESPONSE TO THE 3
LAST PROGRAM ANNOUNCE WANTS, THE
P A 20 AND THERE ARE 18 WITH
CLINICAL TRIALS, AND 40 WITHOUT
THEM SO CLEARLY SOME OF OUR K08
FOLKS ARE WORKING ON AREAS
RELATED DIRECTLY TO TRANSLATING
TO THE CLINIC.
THE NEXT SLIDE IS AGAIN A QUICK
LOOK WE'RE JUST DOING KEY WORD
HITS HERE IN OUR EXISTING
PORTFOLIOS, THE T32s AND THE
R25s IN THIS CASE, WORDS LIKE
REGULATORY, FDA AND INTO THE
CLIRNIC AND THERE'S A HANDFUL OF
GRANTS THAT SHOW UP, THIS IS ALL
DATA FROM REPORTER, IT'S PUBLIC
INFORMATION, CAN YOU MAKE A
JUDGMENT FOR YOURSELF WHETHER
YOU THINK THESE ARE RELEVANT TO
THE ISSUE THAT THE COMMITTEE IS
CONSIDERING.
I WILL THEN ON THE LAST SLIDE
JUST POINT OUT 1 R25 THAT I
THINK IS PARTICULARLY RELEVANT
IF WE CAN GO TO THE NEXT SLIDE,
PLEASE WHICH IS THE 1 THAT
SUPPORTS THE SO CALLED VAIL
WORKSHOP TOGETHER WITH AACR AND
ASCO, THIS IS A WORK LONG
WORKSHOP DESIGNED TO TRAIN EARLY
INVESTIGATORS IN THE BEST
PRACTICE OF EARLY TRIAL DESIGN.
THEY RECENTLY PUBLISHED THEIR
FINDINGS, I REPORT IT UP THERE,
BUT THEY REPORTED THAT
BACKGROUND OF STUDENTS ATTENDED
THAL WORKSHOP, IT'S VERY
COMPETITIVE AND AT THE END OF
THE WORKSHOP ACCORDING TO THE
PUBLICATION, THE FACULTY RATED
92-100% OF THE STUDENTS BRING A
PROTOCOL AND SOME MUCH WORKSHOP
IS SMALL GROUP, WORK, AND
PROTOCOL DEVELOPMENT GROUPS, THE
FACULTY RATED THE VAST MAJORITY
OF THESE PROTOCOLS AS READY FOR
IRB SUBMISSION WHICH THE THEY
RETURN HOME TO THEIR HOME
INSTITUTIONS.
SO THIS IS NOT ENCOMPASS THE
ENTIRE CONTINUUM THAT
DR. HEINBERGER ILLUSTRATED, THAT
WOULD BE VERY DIFFICULT IN A 1
WEEK WORKSHOP BUT IT'S CERTAINLY
TRANSFORMS AN IDEA OF
POTENTIALLY TO A PRACTICAL, YOU
KNOW DOCUMENT THAT CAN BE
IMPLEMENTED AT TRIAL THAT CAN BE
HOPEFULLY LAUNCHED.
THIS YEAR'S WORKSHOP HAD A KEY
NOTE BY DR. KALEN AND IT WAS
VERY INSPIRATIONAL AND
INSTRUCTIVE SORT OF ON HOW
MODERN CLINICAL TRIAL DESIGN CAN
BE DONE AND THE PEOPLE IN THE
WORKSHOP, THE FACULTY OR
EXPERTS, BIOSTATISTICIANS,
CLINICAL TRIALIST AND SO ON, SO
THIS IS I THINK A MODEL THAT 1
COULD SERIOUSLY CONSIDER IN, YOU
KNOW, IN THE--WHICH THE
COMMUNITY COULD USE, TO SUPPORT
EFFORTS IN THIS SPECTRUM.
AND I THINK THAT'S MY LAST
SLIDE.
I DO HAVE A COUPLE OF BACK UP
SLIDES IN CASE PEOPLE WANT TO
LEARN MORE ABOUT THE MECHANISMS
BUT THAT'S WHAT I WANTED TO
SHARE WITH THE COMMITTEE TODAY.
THANKS.
>> OLIVER, I THINK YOU HAVE AN
INTERNAL CURRICULUM YOU TEACH
FOR THE INTRAMURAL
INVESTIGATORS, CORRECT?
>> WE DO, WE HAVE A COURSE
CALLED TRACO, I HAVE TO SAY IT'S
A BIT OF A SURVEY COURSE, NOT
NEARLY AS INDEPTH AS WHAT WOULD
BE REQUIRED, THIS IS AN LECTURE
COURSE THAT GIVES YOU AN IDEA OF
THE LANDSCAPE OF WHAT IT MEANS
TO IDENTIFY TARGETS AND DEVELOP
THINGS BUT I DON'T THINK IT
COMES--MOVES ALONG ENOUGH TO THE
POINT WHERE SOMEONE WOULD BE AS
CAPABLE AS I THINK YOU WOULD
LIKE THEM TO BE FROM YOUR
INTRODUCTION, BUT CERTAINLY A
FOUNDATION 1 COULD BUILD ON.
>> SO CERTAINLY, WE CAN OPEN IT
UP TO THE FLOOR FOR ADDITIONAL
DISCUSSION OR THOUGHTS ON THE
NEED OR THE PRIORITIZATION FOR
SOMETHING LIKE THIS?
I KNOW ANN HAS HAD A LONG
HISTORY OF DOING THESE KINDS OF
THINGS AND FRANCIS AS WELL,
THROUGH THE SPORES, ET CETERA.
>> YEAH, SO 1 THING THAT WE DID
AND IT DIDN'T COME UP TODAY BUT
I THOUGHT AT THE TIME WHEN WE
SET UP THE NANO TECHNOLOGY
ALLIANCE FOR CANCER AT THE NCI,
WE ALSO SET UP SOMETHING CALLED
THE NANO TECHNOLOGY
CHARACTERIZATION LABORATORY.
AND ROSE, I ASSUME WE STILL HAVE
THAT ONGOING, IT'S REALLY QUITE
A RESOURCE AND IT ALLOWED US TO
DID SOME THINGS EARLY ON TO KIND
OF ENABLE THAT ENTIRE FIELD.
AND FDA ACTUALLY PARTNERED WITH
US ON THAT, ACTUALLY THROUGH THE
IOTF, AND SO, THERE MAY BE AN
OPPORTUNITY HERE TO DO--I'VE
ALWAYS THOUGHT THERE'S AN
OPPORTUNITY HERE TO DO SOMETHING
LIKE THIS FOR CELL THERAPIES
ESPECIALLY BECAUSE THERE ARE
LOTS OF ISSUES IN TERMS OF
STANDARDS, IT'S THERE THAT HAVE
TO BE RESOLVED, ESPECIALLY IN
TERMS OF SCALING, SO, YOU KNOW
IT MIGHT BE WORTH CONSIDERING
THAT APPROACH BECAUSE WE DO HAVE
A GREAT MODEL, AT FREDERICK AND
YOU KNOW IT'S BEEN IN PLACE FOR
A LONG TIME.
SO THAT'S 1 THING, THE OTHER
THING THOUGH IS WE DO HAVE, AND
ROSE, I THINK YOU ALOUDED TO
THIS, WE DO HAVE A FEW, A FEW
CANCER CENTERS, SAY I FEW
PARTNERS AT NCI THAT ACTUALLY
HAVE QUITE A BIT OF SCALE
CAPABILITY.
AND I'M NOT SURE THAT WE'VE EVER
REALLY TAKEN ADVANTAGE OF THAT
FROM AN NCI PERSPECTIVE, I THINK
WE ENABLED OTHER PEOPLE TO TAKE
AIDE VANTAGE OF IT AND SO, 1
LAST TECHNOLOGY TRANSFER I WILL
SAY, IF I LOOK AT THE CHECK
POINT INHIBITORS, FRANKLY, I'M
NOT SURE THAT WE WOULD HAVE
ANSWERED THE INHIBITORS WITHOUT
THE NCI BECAUSE WE, THROUGH THE
RAID PROGRAM WE DID PRODUCE
THOSE MOLECULES FOR PEOPLE WHO
ACTUALLY WON THE NOBEL PRIZE, SO
I THINK NCI'S PLAYED A BIG ROLE
AND CAN PLAY AN EVEN BIGGER ROLE
IN THE FUTURE, I THINK ROSE
IS--AND HOWARD'S DONE A GOOD JOB
OF KIND OF LAYING THIS ALL OUT
BUT THERE'S A LOT OF OPPORTUNITY
HERE, SO--THANK YOU AMY FOR
BRINGING THIS FORWARD, I THINK
IT'S A REAL NEED.
>> AND 1 OF THE THINGS, YOU JUST
SAID, ACTUALLY KIND OF MAKES THE
POINT EVEN FURTHER, WHICH IS THE
FACT THAT MANY INVESTIGATORS
AREN'T EVEN AWARE OF THE NCI,
VARIOUS INITIATIVES, RESOURCES,
RAID, YOU KNOW NEX, ALL THESE
THINGS, YOU TALK TO ALMOST ANY
INVESTIGATOR, VERY FEW OF THEM
ARE REALLY FAMILIAR, SO, IF
THESE--THERE WAS LET'S SAY 1-2
YEAR LONG CURRICULUM, BASED AT
THE NCI THROUGH LET'S SAY WEB
BASES OR WHATEVER, PARTIALLY,
YOU WOULD MAKE ADD ON TO THE
ASCO COURSE THAT OLIVER ALLUDED
TO AT THE VERY END THEN THAT
COULD BE PART OF THE CURRICULUM
WHICH IS ACTUALLY TO EDUCATE
THESE INVESTIGATORS WITH REGARDS
TO NCI, FDA RESOURCES, ET
CETERA.
>> IN IS FRANCIS, I HAVE 2
COMMENTS.
THE FIRST IS ACTUALLY
VERIFICATION, THE CORE, THE 2
YEAR COURSE THAT OLIVER
PRESENTED, I THINK THAT'S
FANTASTIC.
I'M WONDERING IS THAT FOR EARLY
INVESTIGATORS OR EVEN MORE
ESTABLISHED INVESTIGATOR WHO IS
NEED EXPERTISE IN THAT AND THEY
COULD ALMOST BE LIKE A TRAIN THE
TRAINER, THEY COULD GO BACK TO
THIS AND TRAIN THE OTHER
INSTITUTIONS.
SO YOU CAN ANSWER THAT BUT I
WANT TO MENTION AND TOUCH ON
SOMETHING THAT AMY, I THINK YOU
ALLUDED TO, NAMELY, CELL
THERAPIES.
CELL THERAPIES ARE CHALLENGING,
SMALL MOLECULES CAN DO A LOT OF
WONDER RECALL PRECLINICAL
STUDIES, ANIMAL STUDIES AND SO
ON BUT WHEN YOU GET TO CELL
THERAPIES AND OF THEM WITH
IMMUNOTHERAPY, YOU REALLY CAN'T
DO MUCH WORK PRECLINICALLY YOU
KNOW IN ANIMALS, AND THAT'S AS
YOU ALL KNOW FROM YOUR OWN WORK,
IT'S BEEN A CHALLENGE.
I WONDER WHAT-HOW THAT CAN BE
FACILITATED?
I MEAN MOST OF THE BOTTLENECKS
ARE REGULATORY, FDA, YOU KNOW
WANT TO GO FOR THE IND AND THE
KIND OF THINGS YOU NEED TO
PRESENT, IT'S QUITE CHALLENGING
AND AND I THINK TO ADVANCE THE
FIELD, PROGRESS IN THAT AREA,
YOU KNOW, YOU KNOW MAKES IT
EASIER OR FINDING SOME OTHER
PARADIGMS TO,A LOW THESE TO MOVE
FORWARD MUCH MORE QUICKLY.
I WONDER WHAT AMY, HAVE YOU A
LOT OF EXPERIENCE IN THAT, WHAT
YOUR THOUGHTS ARE?
>> WELL, FRANCIS, YOU KNOW YOUR
COMMENT RIGHT NOW ALMOST MAKES
ME THINK MORE OF AN RFA TO
DEVELOP THE PRECLINICAL MODELS.
AND I WANTED TO REALLY FOCUS IN
ON TRAINING.
I'M NOT SAYING THAT THAT'S NOT
AN ISSUE, HOW ARE YOU THINKING
ABOUT THAT, FRANCIS, IN THE
CONTEXT OF A TRAINING SORT OF
INITIATIVE BASED AT THE LEVEL OF
THE NCI?
>> MM-HMM.
THAT COULD BE 1 WAY TO, APPROACH
IT, BUT OLIVER, COULD YOU TOUCH
ON WHETHER THE FELLOWSHIP IS FOR
YOUNG INVESTIGATORS OR YOU KNOW
ANYBODY WHO'S ACTIVE AND NEEDS
THAT KIND OF TRAINING.
>> IT'S PRIMARILY A FELLOWSHIP
OFFERED TO PEOPLE AT THE POST
DOCTORAL STAGE, TO SENIOR POST
DOCS, THE FORM OF IT IS THAT YOU
WORK AT FDA FOR 2 YEARS,
EMBEDDED THERE AND LEARN THEIR
FIRST HAND WHAT THE STEPS ARE.
DOESN'T MEAN YOU HAVE TO STAY AT
FDA BUT MANY PEOPLE DO.
SO YOU COULD CONCEIVABLILY TAKE
IT AS A JUNIOR INVESTIGATOR BUT
IT WOULD BE HARD TO FIT IT IN
ALONGSIDE, ACTUALLY LAUNCHING
YOUR INDEPENDENT CAREER.
>> YEAH THAT WOULD BE DIFFICULT
FOR ESTABLISHED INVESTIGATORS.
MAYBE THEY COULD BENEFIT FROM
SOME OF THE COURSES THAT YOU
KNOW SPECIALIZED COURSES AND
THINGS LIKE THAT.
WE HAVE A LOT OF ESTABLISHED
INVESTIGATORS NEED THE
EXPERTISE, THEY LACK IT AND IT
HAMPERED THEIR PROGRESS IN
DEVELOPING NEW AGENTS.
>> OLIVER, JUST A POINT OF
CLARSKS AND THEN I WILL
RECOGNIZE $FINGER, HOWEVER DOES
IT INCLUDE CURRICULUM IN THE
MORE EARLY LIKE DRUG DEVELOPMENT
TEST ARTICLE OR IS IT MOSTLY
BALANCED TOWARD THE LATER STAGE
ALREADY HAVE A TARGET, ALREADY
HAVE TEST ARTICLES, ALREADY HAVE
A LEAD AND YOU'RE KIND OF
IMPLEMENTING DOWN THE IND AT
THAT STAGE OF TWEPMENT.
>> SO IT'S PURPOSE IS NOT TO
TRAIN YOU TO DEVELOP YOUR OWN
DRUGS INTO THE CLINIC, THE
PURPOSE IS REALLY FOR YOU TO BE
EMBEDDED WITH AN FDA TEAM AND
LEARN THE EXPERIENCE THAT, IT'S
LIKE BECOMING A PROGRAM OFFICER
FOR A COUPLE OF YEARS, YOU WOULD
LEARN THE--THAT DISCIPLINE.
IF YOU CHOOSE TO STAY AT FDA,
YOU CONTINUE IN THAT ROLE, BUT
IF YOU DEPART, YOU CAN BRING
THAT EXPERTISE WITH YOU TO
RESEARCH PROGRAMS IN INDUSTRY OR
IN ACADEMIA.
>> I WANT TO RECOGNIZE
DR. FINKER.
>> THANK YOU.
CAN YOU HEAR ME ALL RIGHT?
>> YEAH, WE CAN HEAR YOU DOCTOR.
>> ALL RIGHT, DR. HEIMBERGER
MENTIONED STEPS FOR SUCCESS OF
THE TRAINING AND THE
[INDISCERNIBLE], I SENT, I'M
KIND OF--
>> HOWARD, YOU HAVE A REALLY BAD
ECHO, WE CAN BE THE HEAR YOU
DR. FING ERT,.
>> I THINK YOU HAVE A PHONE OR
SOMETHING,.
>> IT LOOKS LIKE YOU'RE LOGGED
IN TWICE.
NYEAH, LET ME DO THIS.
IS THAT BETTER?
>> YEAH, IT DOES SEEM TO BE
BETTER, YES, I'M SORRY CAN YOU
REPEAT YOUR COMMENT?
>> YES, SO COMING AT THIS MORE
FROM A PERSPECTIVE OF THE
INDUSTRY VERSUS [INDISCERNIBLE]
LIKE THIS FOR COUPLE DECADES
NOW.
>> HOWARD YOU'RE STILL MUTTLED,
YOU HAVE A PHONE OR A--
>> I MUTED THE PHONE.
>> WE STILL HAVE AN ECHO.
>> IS THAT BETTER?
>> HELLO.
>> NOW WE HAVE YOU ON THE SCREEN
TWICE.
>> IS THAT BETTER?
>> DR. FING ERT, WHILE YOU'RE
WORKING THROUGH THE TECHNICAL
ISSUE CAN I MOVE ON TO
DR. CARPPTEN.
>> YEAH, THANK YOU.
>> SURE.
>> HOPEFULLY YOU CAN HEAR ME
OKAY?
>> YEAH, I WAS INTRIGUED BY THE
FELLOWSHIP TRAINING CONCEPT AND
IDEA PARTICULARLY AS WE--AGAIN
AND I'LL BE THE FIRST TO SAY IT,
TRAINING UNDERREPRESENTED
MINORITIES IN THIS AREA.
I KNOW THERE'S AN AMAZING
FELLOWSHIP PROGRAM THAT'S BEEN
CREATED TO TRAIN CLINICAL
FELLOWS, RIGHT IN ONCOLOGY
THROUGH, YOU KNOW INDUSTRY, AND
NONPROFIT, I DON'T WANT TO NAME
NAMES BUT THINGS LIKE IT WOULD
BE AN AMAZING OPPORTUNITY.
WE THINK ABOUT SOME OF THE
MEDICAL SCHOOLS OF THE
HISTORICALLY BLACK COLLEGES LIKE
MOORE HOUSE SCHOOL OF MEDICINE,
HOWARD UNIVERSITY WHERE THE POST
DOCTORAL FELLOWS THAT COULD
REALLY BENEFIT FROM THAT TYPE OF
PROGRAM AT THE FDA, LEARNING
ABOUT PRECLINICAL WORK AND YOU
KNOW HOW THAT FITS INTO THE
ENTIRE DRUG DEVELOPMENT, THE
CRITICAL PATH FOR DRUG
DEVELOPMENT, SO JUST CONSIDERING
THAT IDEA ASLET NCI CONTINUES TO
WORK ON DEVELOPING PROGRAMS AND
PLATFORMS FOR ENHANCING
DIVERSITY AND BIOMEDICAL
RESEARCH, I THINK THIS IS THE
PERFECT TYPE OF CONCEPT, TO
ADVANCE IN THIS AREA, SO JUST
SOMETHING TO CONSIDER.
>> DR. CARPTEN, I WANT TO SEGUE
ON WHAT YOU'RE SAYING AS WELL,
THE THINKING FROM MY PERSPECTIVE
IS TO HAVE SORT OF A MANY BODY
OF CURRICULUM AT THE NCI LEVEL
AND THEN WE ACTUALLY SPOKE ABOUT
THE VARIOUS CANCER CENTERS, ET
CETERA, WHAT DO YOU DO REALLY
WELL?
WHAT'S UNIQUE AND SPECIAL ABOUT
YOUR CANCER CENTER?
AND THEN THAT THERE THEIR
OPPORTUNITY TO TO SHINE IN THAT
DOMAIN, SO HOW DO YOU ADDRESS
DIVERSITY, CLINICAL TRIAL
ENROLLMENT?
MAYBE THAT NEEDS TO BE AT 1
PARTICULAR CENTER TO REALLY
EXCEL THAT SO THAT THEY ARE SORT
OF LIKE A MASTER CLASS OF HOW DO
YOU DO THIS AND THEN THAT FORMS
PART OF THAT CURRICULUM.
>> BECAUSE TO BE HONEST THE
CANCER CENTERS STRUGGLE.
>> YEAH,.
>> SIGNIFICANTLY RIGHT FROM IN
AREA AND COULD BE AN OPPORTUNITY
TO EXPAND.
>> AND ANN, YOUR HAND IS UP?
>> A COUPLE THINGS, GOING BACK
TO OLIVER'S DESCRIPTION OF THIS
FDA FELLOWSHIP IS REALLY AN
INTERESTING WAWZ BECAUSE WHEN WE
SET THAT UP THROUGH THE IOTF AND
I THINK OLIVER, IT WAS 2005 OR
SO, I THE THING WE WANTED TO
HAVE HAPPEN, FIRST OF ALL THESE
ARE MDs AND AT LEAST AT THIS
TIME THEY ALSO SPENT TIME IN THE
CLINICAL CENTER, BUT THE NCI IS
ALSO A REGULATED ENTITY AS FAR
AS FDA GOES, SO WE HAD TO BE
VERY KIRFUL HOW WE SET THAT UP
AND SO THERE ARE LOTS OF RULES
AND REGULATIONS BUT OLIVER MADE
THE POINT, THEY'RE IMMERSED IN
FDA, IT'S REALLY A GREAT
OPPORTUNITY AND THESE PEOPLE ARE
SNAPPED UP AS YOU CAN IMAGINE.
BUT I ALSO WANT TO COME BACK TO
THE IDEA OF MAYBE, YOU KNOW
CATCHING THE VAIL COURSE AND
USING IT TO YOUR POINT, YOU
KNOW, THAT'S A REALLY GOOD
OPPORTUNITY, IT'S A WHOLE WEEK,
WE TRAIN A LOT OF PEOPLE THROUGH
THAT COURSE AND I THINK IT COULD
BE, YOU KNOW NCI REALLY SORT OF
STEPS IN AND TAKES THE LEAD
THERE, SO IT MIGHT BE A GREAT
PLACE FOR US TO DO THAT AND BUT,
YOU KNOW WHAT ABOUT JUST USING
THE CANCER CENTER DIRECTORS GET
TOGETHER ALL THE TIME, I MEAN
NOT ALL THE TIME, DOUG BRINGS
THEM TOGETHER A COUPLE TIMES A
YEAR AND I KNOW AND HE MAY WANT
TO COMMENT O THAT BUT THIS IS
SOMETHING THAT MAYBE THE WHOLE
GROUP SHOULD TAKE ON, NOT JUST,
YOU KNOW, I THINK THAT WOULD BE
VERY EFFECTIVE IF THEY WOULD
AGREE TO DO THAT KIND OF SHARING
AS YOU JUST HAD 1.
>> DR. FING ERT, I SEE YOUR HAND
IS RAISED.
>> YEAH, CAN YOU HEAR ME NOW
WITHOUT A PROBLEM?
>> NO, WE STILL SEE 2 OF YOU
HOWARD.
>> I DON'T KNOW WHAT TO DO.
>> I THINK OUR MODERATOR'S COULD
MUTE 1 OF HISES LINES PERHAPS.
NOW HE WENT AWAY.
>> YEAH, WE LOST HIM ALTOGETHER
NOW.
>> MAYBE THAT'S HIS DIGITAL
TWIN.
SNRKSZ DID YOU WANT TO SAY
SOMETHING.
>> I REALLY APPLAUD WHAT YOU ARE
TRYING TO DO BUT I THINK IT'S
VERY IMPORTANT TO TRY TO
DISTINGUISH DIFFERENT PEOPLE'S
NEEDS, THE NEEDS FOR--I'M SURE,
ROSE WILL--CAN SAY THIS MUCH
MORE ARTICULATELY THAN ME, BUT
THE NEEDS FOR SETTING UP
CLINICAL TRIALS ARE VERY
DIFFERENT FROM SOMEBODY WORKING
IN THE LABORATORY TRYING TO DO
TRANSLATIONAL RESEARCH AND
FIGURING OUT HOW TO NEGOTIATE
THAT BECAUSE, YOU KNOW AS YOU
WERE SAYING AT THE OUTSET,
THATIA A MULTIFACETED PROBLEM
AND WRIERS DIFFERENT KINDS OF
INFORMATION.
THE REALLY IMPORTANT ASPECT IS
THAT HAVING RESOURCES SO YOU CAN
GET THAT INFORMATION BUT IF
YOU'RE TRYING TO DO IT IN THE
LAB AND YOU HAVEN'T DONE IT
BEFORE, I JUST THINK IT'S REALLY
IMPORTANT TO TALK WITH SOMEBODY
WHO KNOWS WHAT IS GOING ON
BECAUSE YOU'LL HAVE YOUR OWN SET
OF QUESTIONS THAT WILL PROBABLY
BE UNIQUE TO YOU AND SPECIFIC TO
YOU.
>> KAREN?
>> THANKS SO MUCH, DOUG, THAT'S
SIM TO WHAT I WAS THINKING, SOME
INSTITUTIONS ACTUALLY DO NOT
SUPPORT SOME OF THE I. P. THAT
IS REALLY PART OF THIS WORK AND
I WOULD LIKE THE IDEA OF MAYBE
THINKING ABOUT THE CANCER CENTER
DIRECTORS AND EVEN EDUCATING
THEM, PERHAPS ABOUT THE
IMPORTANCE OF HELPING TO DRIVE
SOME OF THE INNOVATION BY GOING
BACK TO THE INSTITUTIONS, HAVING
CONVERSATIONS ABOUT THE
IMPORTANCE OF SUPPORTING
INVESTIGATORS, WHO DO WANT TO
TAKE THIS TRACK BECAUSE FRANKLY
THERE ARE SOME INSTITUTIONS THAT
DISSUADE THAT AND I THINK THAT'S
GOING TO BE AN IMPORTANT THING
TO OVERCOME, BECAUSE AGAIN, TO
YOUR POINT, WE DON'T WANT
INVESTIGATORS REALLY EXCITED
ABOUT THIS AND THEN THERE
INSTITUTION SAYS, OH NO, WE WILL
NOT HELP YOU AND,A CYST YOU WITH
THIS IP OR THEY TAKE ALL THE IP
FROM THE INVESTIGATOR AS WELL.
THAT'S THE OTHER COMPONENT.
SO THERE DOES NEED TO BE SOME
EDUCATION AT THE INSTITUTIONAL
LEVEL AS WELL.
>> INTERESTING, OKAY.
>> SO PERHAPS WE'RE NOT LOOKING
AT 1 PERI SAY, COMING BA BEING
TO DOUG'S POINT, MAYBE WE'RE NOT
LOOKING AT 1 PER SE SPECIFIC
COURSE BUT MAYBE A SERIES OF
COURSES THAT NEED TO BE SORT OF
SET UP, DEPENDING ON AND THEN
YOU CAN PICK WHAT YOU NEED IN
YOUR GIVEN SCENARIO, TAKING AS A
MODEL WHAT MAYBE WHAT OLIVER AS
DONE AT THE INTERFACE OF THE
IND, AND THE FDA, MAYBE EARLIER
IN THE PRECLINICAL PIPELINE,
THEN ALLOWING THEM THE SERVICES
THAT ROSE HAS ALREADY TALKED
ABOUT AS FAR AS THE MORE SORT OF
FOCUS QUESTION.
I'M A LITTLE CONCERNED ABOUT NOT
PROVIDING SOME KIND OF
CURRICULUM THOUGH BECAUSE AS
ROSE HAS ALREADY ALLUDED TO, A
LOT OF TIMES THEY DON'T REALIZE
WHAT THAT I HAVE DON'T KNOW.
AND SO, THEY MAY COME TO A VERY
SPECIFIC POINTED QUESTION AND
SAY, OKAY, HOW DO I DO X AND
THEY ADDRESS THAT QUESTION BUT
THEN THEY DIDN'T REALIZE, OKAY,
ALL THESE OTHER THINGS NEEDED TO
ACTUALLY BE CONSIDERED, SO I'M
WONDERING IF WE CAN USE OLIVERS
MODEL FOR THE FDA MAYBE FOR A
VERY SIMILAR SORT OF COURSE WORK
EARLIER AND THEN, YOU HAVE SORT
OF THIS DEPENDS ON WHAT YOU NEED
DEPENDING ON YOUR PROJECTS, ET
CETERA WHERE IN THAT CONTINUUM,
YOU WANT TO DO YOUR COURSE WORK
AT.
OLIVER, YOU HAD YOUR HAND UP?
>> YES, I MEAN, I--1 THING I
WOULD LIKE TO MENTION OR
EMPHASIZE IS THAT THE R25 CANCER
RESEARCH EDUCATION MECHANISM,
PARTICULARLY THE COURSES FOR
SKILLS DEVELOPMENT OF WHICH THE
VAIL WORKSHOP IS AN EXAMPLE,
MIGHT BE A GOOD MODEL.
WE HAVE HAD IN THE LAST FEW
YEARS SOMETHING WE CALLED THE
NASDAQ CONSORTIUM IN SDC WHICH
IS AN UNFORTUNATE COINAGE, BUT
DOESN'T HAVE TO DO ANYTHING WITH
STOCK MARKETS NEXT I WAS GOING
TO ASK THAT.
>> IT WAS A COORDINATED SET OF
R25 GRANTS.
IT WAS AN INTERESTING EXPERIMENT
IN TRYING TO COORDINATE THAT,
FROM WHAT YOU'RE SAYING,
DR. HEIMBERGER, 1 COULD ENVISION
A SERIES OF COURSES PERHAPS FROM
SEPARATE INSTITUTIONS THAT ARE
COORDINATED IN A WAY THAT THEY
COVER THE CONTINUUM AND WHERE
THE LEARNERS MIGHT BE PASSED
FROM 1 COURSE TO ANOTHER FOR 1
TO A BETTER EXPRESSION.
JUST A THOUGHT.
WE DON'T HAVE A READY MADE
MECHANISM FOR THAT BUT CERTAINLY
WE WOULD BE WILLING TO EXPLORE
THAT, THANK YOU.
>> DR. LOWY, YOUR HAND IS UP?
>> THANKS.
I WANTED TO COMMENT ON SOMETHING
THAT KAREN WAS SAYING WHICH IS
THAT WHEN IT COMES TO THE ISSUE
OF INTELLECTUAL PROPERTY, MOST
OF US ARE NOT COMPETENT TO KNOW
THAT OUR WONDERFUL DISCOVERY
WHICH IS OF COURSE UNIQUE HAS,
YOU KNOW THE POTENTIAL FOR
CLINICAL EXPLOITATION AND
DEVELOPMENT AND YOU REALLY NEED
TO HAVE SOME KIND OF GROUP OF
EXPERTS TO ADVISE YOU ABOUT THAT
REGARDLESS OF--ALMOST REGARDLESS
OF WHO YOU ARE.
IN THE INTRAMURAL PROGRAM AT
NCI, WE HAVE THE TECH TRANSFER
BRANCH AND THE STANDING
COMMITTEE THAT MEETS REGULARLY
TO GO OVER EMPLOYEE INVENTION
REPORTS AND THEN TO MAKE
DECISIONS ABOUT WHETHER THEY
SHOULD GO FORWARD OR NOT.
I JUST THINK THERE'S NO
SUBSTITUTE FOR HAVING SOME KIND
OF FORMAL PROCESS.
IT FORCES THE INVEBTORS TO
BASICALLY DESCRIBE WHAT HAVE
THEY DONE OR WHAT IS THEIR
VISION FOR WHAT THE POTENTIAL IS
AND THEN FOR A GROUP OF PEOPLE
WHO ARE NOT DIRECTLY INVOLVED IN
IT TO SAY, HERE'S LAWEDDER DALE
WE THINK THE POTENTIAL IS AND
IT'S UNIQUENESS.
--ITS UNIQUENESS.
>> DR. BARKER?
>> YEAH, JUST 1 MORE COMMENT AND
I THINK DOUG MADE THIS COMMENT,
YOU KNOW SO A BUNCH OF THIS IS
AVAILABLE THROUGH NCI AND I
THINK PART OF OUR ISSUE IS, I
THINK ROSE'S COMMENT ON WHAT IS
AN ALMOST BESPOKE PROGRAM.
YOU CAN CALL IN AND GET
CONSULTATION ON WHERE YOU ARE IN
YOUR PROCESS, WHAT ADVICE YOU
KNOW THAT CAN BE GIIVE WHETHER
YOU'RE FAR INTO THE IND PROCESS
OR EARLY ON IN SCALE UP OR YOU
KNOW WHAT DO I NEED TO DO IN
PRECLINICAL TOXICOLOGY, ET
CETERA, THE WHOLE GAMUT, SO THAT
I--I DON'T THINK THAT A LOT OF
PEOPLE KNOW ABOUT THAT PROGRAM,
I THINK IT'S REALLY A FABULOUS
PROGRAM, THE OTHER THING IS LIKE
THE RAID PROGRAM, THERE'S SO
MUCH AT THE NCI THAT PEOPLE CAN
ACCESS ALREADY, AND SO, 1 OF THE
THINGS THAT WOULD BE GREAT IS IF
PEOPLE JUST KNEW MORE ABOUT
THOSE THINGS AND IT'S ALWAYS A
PROBLEM, BUT YOU KNOW I THINK
IT'S SOMETHING WE SHOULD THINK,
HOW COULD WE HELP IN THAT
REGARD.
AGAIN, IT MAY COME BACK TO THE
CANCER CENTERS UNDERSTANDING
WHAT'S AVAILABLE.
>> IF I CHRONIC LIVER DISEASE
RECOMMEND 1 THING TO TEACH ALL
OF OUR INVESTIGATORS WHO COME TO
US FOR HELP, IT'S JUST A BASIC
UNDERSTANDING OF REGULATORY
SCIENCE BECAUSE REALLY ALL OF
THE DECISIONS FOR TOX, FOR
MANUFACTURING, FOR GMP, IT'S ALL
GOOD JUST QUALITY ASSURANCE AND
REGULATORY SCIENCE AND SO, I
FEEL LIKE THAT WOULD BE THE
LOWEST COMMON DENOMINATOR AMONG
WHAT ALL THESE INVESTIGATORS
NEED TO UNDERSTAND.
>> AND ROSE, HOW LONG DO YOU
THINK A CURRICULUM LIKE THAT
SHOULD LAST?
AND I'M ASSUMING YOU THINK THAT
IT COULD PROBABLY BE DONE VIA
WEB BASED AS OPPOSED TO HAVING
PHYSICALLY SHOW UP.
>> I THINK SO.
LAST YEAR, MY PROGRAM HOSTED A
10 PART SERIES CALLED HOW TO
BRING A NOVEL THERAPEUTIC FROM
BENCH TO BEDSIDE AND WE DID IT,
WE PRESENTED IT OVER 10 FRIDAYS
ALONG THE CRITICAL PATH STARTING
FROM DISCOVERY THROUGH CLINICAL,
YOU KNOW CLINICAL TESTING, AND
IT WAS WELL RECEIVED AND IT'S
ARCHIVED SO FOLKS CAN LOOK AT
IT, BUT YOU KNOW THE PROBLEM
THERE IS THAT IT'S NOT
INTERACTIVE SO YOU CAN'T ASK
QUESTIONS OTHER THAN WHAT THE
AUDIENCE HAD ASKED AND IT'S--YOU
KNOW IT'S NOT VERY INDEPTH, SO,
IT'S A STARTING POINT.
SIMILARLY THE BDP, THE
BIOPHARMACEUTICAL DEVELOPMENT
PROGRAM HAS AN ONLOAN GMP
PYOPROCESSING COURSE YOU CAN
TAKE AND IN FACT WHEN THEY HIRE
NEW STAFF, THEY HAVE TO TAKE IT
AND PASS IT AND I THINK THEY
HAVE TO RETAKE IT EVERY FEW
YEARS TO MAINTAIN THEIR TRAINING
QUALIFICATIONS.
SO, YOU KNOW THERE IS ONLINE
INFORMATION THERE FOR FOLKS WHO
WANT TO GET IT BUT AGAIN, IT'S
NOT INDIVIDUALIZED AND IT'S
NOT--I WOULD SAY IN THE SMALL
MOLECULE REALM, WE HAVE LESS
ONLINE INSTRUCTIONAL MATERIAL
THAT WE MIGHT CONSIDER PUTTING
OUT THERE, BUT YEAH, IT'S A
GREAT BEGINNING OF A
DISCIPLINARY CUSHION AND I
APPRECIATE THAT THE PRECLINICAL
AND IND ENABLING IS VERY
DIFFERENT FROM THE CLINICAL
APPLICATIONS AND THE TRAINING
NEEDS THAT NEED TO GO INTO THAT.
>> DR., YOUR HAND IS UP?
>> YES ACCIDENT I WOULD SAY 1 OF
THE KNOW STRENGTHS OF MODELS
LIKE THE VAIL WORKSHOP IS THAT
IT EMBODIES SOME OF THE
CHARACTERISTICS OF ADULT
LEARNING WHICH IS THAT THE
ADULTS LIKE TO LEARN AROUND
CONCRETE PROBLEMS THAT THEY'RE
FACING, SO AT THE VAIL WORKSHOP,
YOU BRING YOUR NASCENT PROTOCOL
ON TO THE WORK HOP AND YOU GET
HELP ON IT, SOMETHING YOU'RE
VERY INTERESTED IN.
ONLINE LEARNING HAS BEEN SHOWN
TO BE SOMEWHAT EFFECTIVE BUT
DOESN'T EMBODY THE HIGHLY
INTERACTIVE, I'VE GOT A PROBLEM
I WANT TO SOLVE AND I WILL LEARN
HERE HOW TO DO THAT KIND OF
ASPECT, THAT COULD BE DELIVERED
OVER DISTANCES AS WELL, I'M NOT
SAYING IT HAS TO BE IN PERSON
BUT I WOULD ENCOURAGE US TO
THINK ABOUT APPROACHES THAT
ALLOW US TO BRING THEIR RESEARCH
PROJECT TO SUCH A DISCUSSION TO
SEE PERHAPS WHETHER IT HAS IP
LEGS, YOU KNOW CONNECTING TO
DR. LOWY'S CONCEPT THAT MAYBE
THE PROJECT ISN'T THE BEST JUDGE
OF IT BUT MAYBE THEY COULD BE
CONNECT WIDE JUDGES.
SO I JUST WANTED TO MAKE THAT
COMMENT.
THANKS.
>> SO JUST TO CLARIFY OLIVER,
WHAT YOU'RE SUGGESTING IS ALMOST
LIKE A PRECLINICAL WORKSHOP,
BRING THEIR COMPOUND, OR TARGET?
[LAUGHTER]
>> LITERALLY, YES ACCIDENT, BUT
BRING THE IDEA.
>> YEAH.
>> ROSE?
>> SIMILARLY TO GET REAL WORLD
EXPERIENCE AND WE HAVE JUST
RECENTLY ANNOUNCE THAD WE'RE
RECRUITING SOME FELLOWSHIP
PHYSICIANS IN OUR
BIOPHARMACEUTICAL PLANTS, SO
WE'RE TRYING TO HIRE FELLOWS WHO
CAN COME IN FOR 2 YEARS AND
TRAIN IN BIOPROCESSING
UNDERSTANDING WHAT GOES INTO
REGULATORY AFFAIRS AND QUALITY
ASSURANCE AND EVEN THE PROCESS
ITSELF AND ACTUALLY THE FDA JUST
CONTACTED US LAST WEEK TO ASK IF
THEY COULD SEND NEW STAFF TO OUR
FACILITY TO SEE THE CELL THERAPY
SUITES TO SEE HOW THOSE ARE RUN
AND WHAT KINDS OF EQUIPMENT, BUT
I THINK THIS--WITH THE BIGGER--I
THINK THE--A BETTER WAY OR
SOMETHING BETTER TO MOVE TOWARD
IS THE TRAIN THE TRAINER IDEA.
SO I WOULD RATHER SEE
INSTITUTIONS TAKING ON THIS KIND
OF TRAINING INSTEAD OF HAVING
TO, YOU KNOW RELY ON--NOT THE
REMOTE, VIRTUAL TRAINING ISN'T
VALUABLE, BUT I THINK IT WOULD
BE GREAT IF THERE COULD BE SOME
KIND OF CO OPERATIVE EFFORT TO
TRAIN STAFF IN NEEZ ASPECTS OF
TRANSLATIONAL RESEARCH SO THAT
IT BECOMES SELF-PERPETUATING
ONSIGHT SO THAT IT'S--YOU KNOW
THEY BECOME MORE INDEPENDENT
THAT IN THAT REGARD AND THEY CAN
CONTINUE TO TRAIN AS NEW
INVESTIGATORS COME ONBOARD.
>> I THINK MY ONLY CONCERN IS
THAT EVEN AT LIKE 1 OF THE MAJOR
LEADING CANCER CENTERS, THEY
ONLY IN THE LAST 5-60 YEARS
REALLY DEVELOPED A CURRICULUM
AROUND THIS.
AND IT'S THE NUMBER 1 SO I'M NOT
GOING TO NAME THE NAME SO THAT
OUGHT TO TELL YOU WHEN YOU
MOVE,A WAY FROM SORT OF THE
LEADERS, I THINK THERE'S HIEWNL
GIGANTIC GAPS AND EVEN AT THAT
MAJOR INSTITUTION, I SAW NOT
ONCE, NOT TWICE BUT MANY TIMES
WHERE YOU TELL FOLKS, OKAY,
BEFORE YOU GO IN THE PUBLIC
DOMAIN AND YOU START TALKING
ABOUT THIS COMPOUND OR THIS
STRATEGY, MAKE SURE YOU'VE GOT
PROVISIONAL PATENT IN HAND AND
IT WAS THE SAME--IT'S
IEE, AUDIENCERONIC, I HAVE 1
INVESTIGATOR WHO ACTUALLY DID IT
NOT ONCE BUT TWICE WHERE HE LOST
COMMERCIAL ABILITY BECAUSE HE
DIDN'T KEEP TRACK OF HIS STUDENT
PRESENTING AT THE AACR, AND ONCE
IT'S OUT IN THE PUBLIC DOMAIN,
IT'S GONE, SO HE--I THINK
THERE'S AN--AT LEAST MY
IMPRESSION ACROSS CANCER CENTERS
AND THEIR ABILITY TO DO THAT,
THAT WAS PART OF THE REASON WHY
I THOUGHT, OKAY, THIS WOULD BE A
POTENTIAL OPPORTUNITY FOR THE
NCI TO HOUSE THE SORT OF BASIC
KNOWLEDGE BASE GIVEN THE
RESOURCES AND SORT OF THE FDA
AND ALL OF THESE OTHER SORT OF
RESOURCES THAT ARE ALREADY IN
PLACE AND WITH THE CANCER
CENTERS THEN COULD USE THIS AS
THE FOUNDATION THEN, AS OPPOSE
TO EACH CANCER CENTER TRYING TO
DO THIS CURRICULUM, YOU KNOW IN
AND OF ITSELF BECAUSE I THINK
THE TRAINING WON'T BE UNIFORM OR
PER SE GREAT AT ALL.
SO I GUESS THAT'S JUST MY
THOUGHT BACK.
DR. BARKER?
>> YEAH, SO, YOU KNOW, THAT
TOUCHED ON SOMETHING BEFORE THAT
I THINK IS REALLY IMPORTANT AND
THAT IS HISTORICALLY THE NIH
OVER AWRL AND NCI SPECIFICALLY
HAS FILED A LOT OF PATENTS.
I THINK WE STARTED REALLY
REVIEWING THOSE VERY EARLY, I
THINK AROUND 2003/4 AND SET UP A
PROCESS, I THINK MOST
UNIVERSITIES DO THAT BECAUSE YOU
CAN PATENT A LOT OF THINGS BUT
YOU DON'T NECESSARILY HAVE A
MARKET FOR THEM, SO YOU CAN
SPEND A LOT OF MONEY DEFENDING
YOUR PATENTS IF YOU FILE THEM.
ESPECIALLY IF YOU FILE THEM PC T
BUT I DID WANT TO BRING UP 1
ISSUE THAT I THINK IS CRITICALLY
IMPORTANT IN ALL THIS DISCUSSION
IS THAT MOST UNIVERSITIES DON'T
HAVE THE RESOURCES FOR EXAMPLE,
TO MAKE THEIR LABORATORIES GLP
COMPLIANT.
THEY JUST DON'T.
THEY CAN'T CONTROL THE FLOW, THE
SOPs ARE NOT WHAT THEY SHOULD
BE, TO PASS, YOU KNOW AN FDA
INSPECTION AND CERTAINLY IF YOU
TALK ABOUT GMP, THAT'S
EXTRAORDINARILY RARE BECAUSE,
YOU KNOW THE BAR IS VERY, VERY
HIGH AND SO I WANT TO BRING UP 1
THING IS THAT WE HAVE SENT AT
ASU, OCCASIONALLY, WE SEND
PEOPLE, A LOT OF GOOD POST DOC
PROGRAMS, ACTUALLY AT MERK AND
PFIZER AND OTHER PLACES WHERE A
POST DOC CAN GO THERE AND SPEND
2 YEARS LEARNING EVERYTHING
WE'RE TALKING ABOUT.
I'M JUST WONDER, WE'VE NEVER, I
DON'T KNOW, ROSE, IF WE EVER
THOUGHT ABOUT SETTING THAT UP
MORE OFFICIALLY WITH, YOU KNOW
NCI PLAYING SOMETHING OF A ROLE
YOU KNOW AS A SCREENER TO GET
MORE OF OUR CANCER FOLKS INTO
THOSE PROGRAMS THAT ARE LOOKING
FOR POST DOCS IN THE INDUSTRY.
SO THEY'RE VERY ACTIVE PROGRAMS
AND THEY'RE REALLY GOOD
ESPECIALLY, I KNOW SOMETHING
ABOUT THE MERK PROGRAM, AND THE
PFIZER PROGRAM, THEY'RE BOTH
REALLY GOOD.
SO, AND OBVIOUSLY, THEY WOULD
LIKE TO RECRUIT THOSE PEOPLE
INTO THE INDUSTRY IMMEDIATELY
AFTER THEY GET DONE.
>> EXACTLY.
>> BUT NO, A LOT OF THEM COME
BACK TO ACADEMIA.
I THINK IT'S SOMETHING TO GIVE
BACK TO THE INDUSTRY AT LEAST.
>> SOMETHING TO EXPLORE.
>> WELL, OKAY, SO IF THERE'S NO
FURTHER COMMENT, DR. FING ERT,
DID YOU GET YOUR TECH IN IICAL
ISSUE?
>> I HOPE SO, IS THAT BETTER
NOW.
>> YEAH, ACTUALLY IT IS.
>> FANTASTIC.
SO I DID SEND IN A CHAT WITH
WHAT I WAS TRYING TO SAY,.
>> OH, OKAY.
>> I WAS BASICALLY THE MAJOR
POINT HERE IS THE, YOU KNOW WHAT
GETS MEASURED IS WHAT GETS DONE
AND I'M WONDERING IF WE SHOULD
KIND OF TALK ABOUT THE PROPOSED
MEASUREMENTS THAT DR. BOGLER AND
ROSE PRESENTED ABOUT YOU KNOW
PERFORMANCE BASED ON LIKE IRB
SUBMISSIONS AND ALL THAT.
AND ARE THERE OTHER MEASURES
THAT WE SHOULD CONSIDER THAT
MIGHT BE HELPFUL TO US GOING
FORWARD?
EXAMPLES, YOU KNOW INCLUDE, YOU
KNOW THE GENERATION OF
SUBSTANTIAL EVIDENCE, THE
COMPLETION OF THE TRIAL, YOU
KNOW BASED ON EXPECTED
ENROLLMENT, YOU KNOW, THINGS
LIKE--THINGS LIKE THAT.
IT'S BEEN UNFORTUNATE BUT THERE
HAVE BEEN NUMEROUS NCI TRIALS
THAT FAILED TO--NCI SPONSORED
TRIALS THAT SUCCEEDED TO
GENERATE NICE PHASE 1/2 BUT
MAYBE INCOMPLETE ENROLLMENT
ACCORDING TO THE PLAN, TO THE
PROTOCOL PLAN.
BUT, STILL GOT TO GET PUBLISHED
IN MAJOR JOURNALS, SO THAT IS AN
ACCOMPLISHMENT, JOURNAL
PUBLICATION, SURE, GREAT, BUT IN
INDUSTRY, YOU KNOW WHERE I COME
FROM, WE HAVE YOU THAT WITH
CONCERN NOW BECAUSE THERE ARE SO
MANY INDUSTRY TRIALS THAT ARE
UNDERPOWERED AND IF ANYTHING
MISLEADING, AND YET, PEOPLE GET
GRANTS FROM THEM, SURE.
ARE THEY REALLY ADDING BEING
ABLE TO NOT ONLY JUST FILE AN
IND BUT ALSO THEN SUCCEED IN
BRINGING SOMETHING THAT'S
ACCESSIBLE AND COMMERCIALLY
PARTNERS PROPERLY TO REALLY HAVE
IMPACT ON PATIENT CARE.
>> YEAH.
YOUR POINT'S WELL TAKEN DR. FING
ERT, I THINK THE METRICS ARE
WHERE THEY A--BITS LIEN AND IF
SOMEONE'S IN THE PIPELINE, I'M
SURE YOU WOULD AGREE, DO YOU
HAVE THE MECHANISM WORKED OUT,
YOU KNOW WHAT IS THE OFF TARGET
EFFECT OF WHATEVER YOU'RE
WORKING ON, THE METRICS FOR
SOMETHING LIKE THAT WOULD BE
MUCH DIFFERENT AS OPPOSED TO
MUCH LATER STAGE CLINICAL TRIALS
BUT YOUR POINTS ARE VERY WELL
TAKEN, THANK YOU.
>> YEAH, THE OTHER POINT I
BROUGHT UP IS THAT THE IDEA OF
EXPERTISE AND BRINGING IN
EXPERTISE IS SOMETHING I WORKED
WITH IN ACADEMIA, I WAS AT
HARVARD FACULTY AND INDUSTRY AND
I THINK WE HAVE TO APPRECIATION
THAT THAT'S NOT A STATIC THING
THAT JUST HAPPENS, YOU BRING IN
1 EXPERT, YOU KNOW IT REQUIRES
THIS SYSTEMATIC THINKING ABOUT
HOW TO GET--LET THE EXPERT HAVE
DEEP LEARNING AS THEY GO ON AND
THEN THE AUDIENCE AND THE
PROGRAM STAFF HAVING DEEP
LEARNING INCLUDING LEARNING FROM
FAILURES.
YOU KNOW WE'RE QUITE GOOD AT
HEARING FROM PROGRAM STAFF ABOUT
SUCCESSES, THE SBIR PHASE 2
SUCCESSES, WE DON'T REALLY HEAR
ABOUT THE FAILURES, YOU KNOW AND
WHAT HAVE WE LEARNED FROM THE
FAILURES GOING FORWARD.
MAYBE THAT HAS TO BE A PRIVATE
DISCUSSION BECAUSE IT'S
PROBLEMATIC SENSITIVE BECAUSE
THAT'S REALLY WHERE YOU LEARN
AND WHEN I GREW UP IN ACADEMIA,
WE HAD CPCs, CLINICAL
PATHOLOGIC CONFERENCES WHERE THE
PATHOLOGIST CAME IN AND WENT
OVER WHAT THE TRUTH WAS FROM
SOME OF YOU ARE NODDING BECAUSE
YOU KNOW WHAT I'M TALKING ABOUT,
THOSE WERE HUGE LEARNING
EXPERIENCES AND VERY POPULAR AND
THEY'RE PART OF NEW ENGLAND
JOURNAL NOW INTEGRATED INTO IT,
AND THAT'S WHAT I'M THINKING
ABOUT, YOU KNOW LEARNING FROM
THE FAILURES AND PIT FALLS,
THATIA A CULTURE CHANGE.
>> YEAH, THAT COULD OBVIOUSLY BE
INCLUDE AS PART OF THE
CURRICULUM, AS WELL AS PEOPLE
FROM THE BUSINESS SIDE, AS WELL
AS LAWYERS WHEN YOU START
TALKING ABOUT INTELLECTUAL
PROPERTY, THAT KIND OF THING AS
WELL.
DULY NOTED.
>> RIGHT.
>> OKAY, PAULET, I BUILDING
WE'RE RIGHT AT THE TOP OF THE
HOUR, I BELIEVE THE SECOND
COMMITTEE NEEDS TO GET UNDERWAY,
I THANK EVERYONE FOR THEIR VERY
KIND ATTENTION AND I WILL TURN
THIS BACK OVER TO PAULET.
>> THANKS, AMY, FOR THE
SUBCOMMITTEDEE MEETING AND I
WILL TURN IT BACK OVER TO JOYCE
AS SHE IS HELPING WITH THE
SUBCOMMITTEE MEETINGS FOR ME.
>> THANK YOU ALL.
>>WE HAVE TO RUN THE NCI WITH
THE RESOURCES WE GOT FROM WITHIN
GOVERNMENT AND WE HAVE SPLG TO
DO WITH THAT HOPEFULLY.
FIRST OF ALL WELCOME PATRICK
Mc GARY OUR EXECUTIVE
SECRETARY WHO WILL DO MOST OF
THE TALKING TODAY.
IT'S--JUST A LINGS BIT OF
BACKGROUND, YOU KNOW IT'S--I'VE
BEEN AROUND FOR A LONG TIME AND
IT'S A REALLY INTERESTING TIME I
THINK IN NCI'S HISTORY.
I MEAN 1 WE JUST HAD THE 50th
ANNIVERSARY LAST YEAR, BUT I
CAN'T RECALL A TIME EVEN WITH
THE DOUBLING OF THE NIH BUDGET,
YOU KNOW, WHICH WAS A LONG TIME
AGO NOW, BUT WHEN WE'VE HAD THIS
MANY APPLICATIONS COMING IN TO
NCI VERSUS THE OTHER INSTITUTES,
AND THE EXTENT TO WHICH IT'S
REALLY AFFECTING THE PAY LINES
AND CONTINUES TO AFFECT THE PAY
LINES.
SO YOU KNOW IT REALLY SPEAKS TO,
THOUGH, I THINK THE AMOUNT OF
PROGRESS THAT WE'RE MAKING IN
CONSCIENCER RESEARCH, AND SO I
THINK WE HAVE TO DO EVERYTHING
POSSIBLE TO HELP TO PROTECT THIS
BUDGET, CERTAINLY AT THIS TIME,
BECAUSE THERE'S--I KNOW WE SAY
THIS ALL THE TIME BUT I--I THINK
THIS WHOLE CONCEPT OF PRECISION
MEDICINE IS REALLY TAKING OFF
AND MUCH OF WHAT WE HAVE
SUPPORTED AT NCI THROUGH THE
YEARS HAS ENABLED US TO GET HERE
AND WHY HAVE A LOT OF ENERGIZED
PEOPLE OUT THERE WHO REALLY WANT
TO APPLY FOR GRANTS, RO-1 GRANTS
THROUGH OUR RFAs, OTHER WAYS,
SO, THERE'S A LOT GOING ON RIGHT
NOW, RELATIVE TO I THINK--I
THINK THE SENATE AND THE HOUSE
BOTH WANT TO PUT MORE RESOURCES
IN NCI, SO YOU WILL SEE THAT IN
THE BUDGETS AND YOU WILL SEE
THIS YING AND YANG WHICH PATRICK
WILL TALK ABOUT BETWEEN THE
WHITE HOUSE AND THE SENATE AND
HE WILL TELL YOU A LITTLE BIT
ABOUT THE ORIGINAL BUDGET WE HAD
YOU KNOW FOR 2023 IS NOT QUITE
WHAT IT SEEMED TO BE INITIALLY.
IT LOOKED LIKE A SIGNIFICANT
DECREASE IN THE NCI'S BUDGET BUT
THAT'S NOT THE CASE.
BUT WE ARE FACING IN 2023 THE
LAST YEAR OF OUR FUNDING FOR THE
MOON SHOT.
THAT'S A BIG DEAL.
THAT'S A LOT OF MONEY.
AND WE'RE HOPEFUL THAT CONGRESS
IS GOING TO LOOK AT THAT AND
SAY, YOU KNOW WE JUST CAN'T HAVE
THAT HAPPEN, NOT AT A TIME WHEN
WE'RE GETTING THIS KIND OF
RESPONSE FROM THE EXTRAMURAL
COMMUNITY IN TERMS OF IDEAS.
SO, THE 2023 BUDGET PROCESS IS
UNDER WAY, STARTED WITH THE
HOUSE IN JUNE, AND JUST THIS
WEEK, THINGS ARE GOING ON
ACTUALLY ON THE SENATE SIDE, SO,
IT'S LOOKING GOOD, I THINK FOR
NIH AND I THINK BETTER FOR NCI,
BUT I DON'T THINK PERSONALLY
IT'S WHAT IT NEEDS TO BE.
SO PATRICK WILL TALK MORE ABOUT
THE SPECIFICS HERE, BUT I'M--I'M
FRANKLY A LITTLE CONCERNED
BECAUSE AS I LOOK FORWARD THE
PRESIDENT'S MOON SHOT 2.0, TO
THIS POINT WE HAVEN'T SEEN A LOT
OF NEW MONEY REALLY VENTURE
TOWARD THE NCI.
SO, RELATIVE TO THE LAST
SUBCOMMITTEE MEETING WHICH
DR. HEIMBERGER REALLY JUST
FINISHED, I'M WONDERING ABOUT
THE ROLE OF ARP A-H NOW AND
STARTING TO THINK ABOUT SOME OF
THE THINGS WE JUST TALKED ABOUT
IN THAT SUBCOMMITTEE FOR
EXPERIMENTAL THERAPEUTICS IF ARP
A H MIGHT BE 1 OF THOSE VEHICLES
THAT WE COULD ACTUALLY SEE
ACCEPT INTO THIS SPACE AND DO
MORE IN TERMS OF FUNDING SOME OF
THE PRECLENICAL ESPECIALLY
MAYBE, AND EVEN EARLY
TRANSLATIONAL WORK FOR PEOPLE
WHO WANT TO TAKE THEIR GOOD
IDEAS WHICH ARE PROTECTED
FORWARD.
SO ARP A H, IS ALSO KIND OF BACK
AND FORTH BETWEEN THE SENATE AND
THE HOUSE AND THE WHITE HOUSE.
SO THERE IS AN ONGOING
CONVERSATION ABOUT WHETHER OR
NOT IT SHOULD BE WITHIN NIH
WHICH IS WHAT THE PRESIDENT
WOULD LIKE AND/OR IT SHOULD BE
OUTSIDE THE NIH COMPLETELY.
IF IT'S IN THE NIH, THE WHYS
HOUSE SAID IT COULD CERTAINLY BE
OUTSIDE OF WASHINGTON BUT I
THINK THE PRESIDENT WANTS TO
MAKE SURE THAT THAT WHICH IS
AVAILABLE IN TERMS OF RESOURCES
TO THE NIH ARE AVAILABLE TO ARP
A H.
AND THE OTHER SIDE OF THAT
CONSTANT ISSUE ACTUALLY, HER
COLLEAGUES WOULD LIKE TO SEE IT
OUT OF NIH, THAT THEY'RE
THINKING IS IT WOULD BE A MORE
CREATIVE, A FASTER AND MORE
NIMBLE AGENCY.
ALL OF THAT IS STILL UNDER
DISCUSSION AND PATRICK WILL ALSO
TALK A LITTLE BIT ABOUT THAT BUT
YOU KNOW THEREYA A LOT OF MONEY
HERE THAT'S GOING TO BE GOING
INTO A WHOLE NEW SORT OF I THINK
CONSTRUCT FOR HOW WE CAN SUPPORT
RESEARCH AND I THINK CANCER
SHOULD FIGURE OUT WAYS TO TAKE
ADVANTAGE OF THAT.
SO--SO, I ACTUALLY, I'VE GOTTEN
SOME QUESTIONS IN THE LAST FEW
WEEKS FROM A COUPLE OF YOU THAT
WE CAN TAKE UP AT THE END OF OUR
COMMITTEE MEETING TODAY AND WE
CAN MAYBE ASK PATRICK'S ADVICE
ON HOW WE MIGHT ANSWER THESE.
SO PATRICK WHY DON'T I INTRODUCE
YOU AND TAKE US THROUGH WHAT YOU
KNOW AND WHAT YOU DON'T KNOW
ABOUT 2022, WE KNOW SOMETHING
ABOUT 2023, I GUESS WE WILL
SPECULATE A BIT BUT WE KNOW A
FEW THINGS, SO PATRICK, TAKE IT
AWAY.
>> THOWCH ANN, IT'S GOOD TO BE
WITH YOU AGAIN, DR. BARKER AND
THE OTHER MEMBERS OF THE
SUBCOMMITTEE.
CAN WE BRING UP THE SLIDES?
YEAH.
APPRECIATE IT.
YEAH, SO WE CAN MOVE ON TO THE
NEXT SLIDE, PLEASE.
SO THIS IS THE AGENDA SLIDE FOR
TODAY'S MEETING, I WILL RUN
THROUGH 3 FISCAL YEARS,
BEGINNING WITH OUR CURRENT YEAR
FY2022, I DON'T THINK IT WILL
SURPRISE YOU THAT CLARITY ABOUT
THE 3 FISCAL YEARS IS MORE AND
MORE CERTAIN AT THE CURRENT YEAR
WHICH IS RAPIDLY COMING TO A
CLOSE AS OF THE END OF SEPTEMBER
JUST A MONTH AWAY, CONGRESS
CONTINUES TO DELIBERATE ON FY20
TWA AS I WILL DISCUSS WHILE AT
THE SAME TIME THE ADMINISTRATION
BEGUNS TO FORMULATE THE FY2024
BUDGET.
THE ADMINISTRATION WON'T DELIVER
THAT BUDGET FOR FY2024 TO
CONGRESS UNTIL 7-8 MONTHS FROM
NOW.
SO WE HAVE 1 THAT'S COMING TO A
CLOSE, 1 THAT WE'RE WATCHING
EVENTS UNFOLD IN CONGRESS AND 1
WHERE WE'RE WATCHING EVENTS
UNFOLD WITHIN THE ADMINISTRATION
WHICH WILL EVENTUALLY TAKE SHAPE
FURTHER IN CONGRESS.
AND THAT'S WHEN WE'LL KNOW THE
SCOPE OF NCI PROGRAMS IN
PRESIDENT BIDEN'S SUPER CHARGED
MOON SHOT THAT HE ANNOUNCED THIS
PAST FEBRUARY.
SO, NEXT SLIDE, PLEASE.
SO WHAT YOU SEE ON THE SLIDE IS
THE CLASSIC WAY NCI HAS
PRESENTED OUR APPROPRIATED
BUDGET ACROSS THE YEARS IN
MARCH, IT'S A COMPARISON, SO CAN
YOU WATCH THE GROWTH AND CHANGES
AND IN MARCH, THE PRESIDENT
SIGNED THE OMNIBUS
APPROPRIATIONS.
AS YOU CAN SEE ON THE FAR RIGHT
NCI TOTAL APPROPRIATION IS JUST
SHY OF 7 BILLION AND THAT
INCLUDES 3 COMPONENTS,
APPROXIMATELY 6.7 IS OUR BASE,
THE LARGE BLUE SECTION OF THE
GRAPH, COLUMN, AND ADDED TO THAT
BASE IS $50 MILLION, ACTUALLY
IT'S INCLUDED WITHIN THE BASE
TECHNICALLY BUT FORGET ABOUT THE
TECHNICALITYS, $50 MILLION FOR
THE CHILDHOOD CANCER INITIATIVE,
SHOWN IN GREEN AND THEN FURTHER
ADDED IS MOON SHOT, NCI'S BASED
APPROPRIATION GETS AN ADDITIONAL
194 MILLION IN FY2022 FOR THE
CANCER MOONSHOT AND THAT ALL
APPEARS IN ORANGE.
THAT TOTAL, ON THE FAR RIGHT
COLUMN IS 353 MILLION INCREASE
OVER FY2021 WHICH IS AN
ADDITIONAL 5.4%.
AS DR. BARKER HAS ALREADY TOLD
US, FY2022 IS THE SIXTH OF 7
YEARS OF CANCER MOONSHOT.
THEY LAUNCHED IT BACK IN 2017
AND LET'S MOVE ON TO THE NEXT
SLIDE, PLEASE.
SO I'M REPRISING THIS, THIS IS
SOMETHING I SHOWED IN JUNE AND
I'M DISPLAYING THE GRAPHIC THAT
AWLINGS APPEARED IN THE--ALSO
APPEARED IN THE APRIL 1st
BOTTOM LINE POST AND THE TABLE
JUST DISPLAYS THE PROMINENT NCI
GRANT FUNDING POLICIES FOR THE
CURRENT FISCAL YEAR FY2022.
AT THE VERY BOTTOM, YOU CAN SEE
A LINK THERE FOR THE FULL
FUNDING POLICIES FOR
SUBMECHANISMS OTHER THAN WHAT
WE'RE TALKING ABOUT HERE.
SO THE 3 GRANT POLICIES
R--EXCUSE ME R01S, THEY'RE
FUNDED AT THE 11th PERCENTILE,
ESIs ARE AT THE 16th
PERCENTILE, AND RO-1S ARE AT THE
11 AND THOSE ARE THE SAME
POLICIES WE HAD IN THE PRIOR
YEAR FY2020-2021, WE HAD TO MAKE
SURE WE COULD PAY ALL THESE NEW
GRANTS.
WE MAKE THIS COMMITMENT TO A PAY
LINE, YOU KNOW AS EARLY AS
POSSIBLE IN THE FISCAL YEAR BUT
WE NEED TO BE SURE WE CAN AFFORD
ALL THAT, WE NEEDED TO TAKE A 2%
REDUCTION, THAT IS TO PAY
NONCOMPETING GRANTS AT 98%,
HOWEVER, THERE ARE A FEW
TARGETED EXCEPTIONS AND THOSE
APPEAR IN THE RIGHT SIDE OF THE
TABLE.
SO THAT'S THE OUTLINE OF WHAT WE
DID THIS YEAR.
WE WILL NOT HAVE FISCAL YEAR IN
SEPTEMBER 30th AND AT THE END
OF THE CALENDAR YEAR OR SOMETIME
IN JANUARY, PERHAPS, WE WILL
HAVE THE SUMMATION, WE WILL KNOW
HOW MANY WE'VE FUNDED IN TOTAL,
AND ALL THE VARIOUS GRANT
SUBCATEGORIES AND WE ALWAYS
REPORT THAT OUT AS WELL.
NNEXT SLIDE, PLEASE.
SO I'M JUST REMINDING YOU BACK
TO THE AGENDA, WE'RE MOVING ON
TO 2023 NOW AND WHAT THE OUTLOOK
LOOKS LIKE THERE.
SO NEXT SLIDE, AGAIN.
AND BEFORE I GET TOO DEEP INTO
IT, I JUST WANT TO COME BACK TO
1 THING, YOU SAW A MULTISLIDE
PRESENTATION HERE AND I MEAN THE
BIG QUESTION FOR 2023 IS WHAT IS
OUR APPROPRIATION, WHAT WILL OUR
APPROPRIATION ALLOW US TO AFFORD
IN TERMS OF NEW GRANTS AND THIS
SHOWS YEAR BY YEAR, IF WE MAKE
COMMITMENTS TO INCREASE THE PAY
LINE, GOING FROM THE TENTH
PERCENTILE IN THE FAR LEFT IN
RED AND MOVING TO THE 11th IN
21 AND 22, WE TAKE ON ADDITIONAL
BURDENS AND THAT'S AT THE BOTTOM
OF IT, IN THE DEEP RED, GREEN,
AND BLUE.
I THOUGHT ABOUT THIS A LITTLE
BIT AND I JUST CAME UP WITH THIS
ANALOGY, AND IT'S BEEN LIKE IF
YOU ARE CLIMBING A MOUNTAIN
AND--BUT IN BEARING THIS MIND
YOU, THAT PLAY OUT ACROSS FUTURE
FISCAL YEARS TYPICALLY 5 YEARS
FOR AN RO-1 AND YOU MOVE TO NEXT
BASE CAMP AND YOU HAVE THE PRIOR
YEAR'S BURDEN, YOU'RE PAYING AS
NONCOMPETING AND YOU'RE TAKING
ON ADDITIONAL BURDEN FOR THE
COMPETING YEAR AND MOVING TO YET
AGAIN THE NEXT BASE CAMP, YOU
HAVE THE PRIOR 2 YEARS, BURDEN
THAT YOU'RE CARRYING UP THAT
MOUNTAIN AND YOU WANT TO TAKE ON
ANOTHER BURDEN, SO IT DOES GROW,
IT'S A BURDEN WE WELCOME IF WE
CAN MANAGE IT AND THAT IS ALL
BEING MANAGED BY THE DOLLARS WE
RECEIVED.
SO LET ME DO THAT BY MOVING ON
TO THE NEXT SLIDE, PLEASE.
I JUST WANT TO SAY THERE ARE
OTHER FACTORS, WE TOUCHED ON
THIS, I WILL BE VERY BRIEF, YOU
KNOW ALL OUR DOLLARS DON'T COVER
THE GROWING VOLUME WITH MORE
AWARDS AND THEY LOSE VALUE
REERATED TO INFLATION AND THAT
WE HAVE SOME AWARDS THAT CAN
MOVE FROM 5-7 YEARS SO THAT LOAD
OF 5 YEARS IS 7 YEARS THAT
YOU'RE CARRYING, SO JUST WANT TO
TOUCH ON THAT AS WELL AND THEN
WE'LL MOVE ONCE AGAIN MOVING TO
THE NEXT SLIDE TO LOOK AT 2023
WITH THAT BACKGROUND AND YOU CAN
SEE THAT I HAVE ADDED IN THE FAR
RIGHT 2 ADDITIONAL COLUMNS, THEY
REFLECT THE HOUSE PROPOSED AND
THE SENATE PROPOSED, NEITHER OF
THESE BILLS HAVE BEEN CONSIDERED
IN THE FULL HOUSE AND THE
SENATE.
THEY'RE ALL RECOMMENDATIONS IN
SOME FORM OF ANOTHER BY THE
SUBCOMMITTEES OF JURISDICTION,
LABOR, HHS APPROPRIATIONS
SUBCOMMITTEE.
BUT YOU CAN SEE HERE, THE
INCREASED PROPOSED IN THE HOUSE
AND PROPOSED THROUGH THE SENATE,
AND WE ARE WATCHING THAT ALL
PLAY OUT IN CONGRESS NOW AND
I'LL DISAPPOINT YOU PROBABLY BY
SAYING THIS MAY PLAY OUT WELL
INTO THE FALL AND INTO THE
WINTER AND POSSIBLY EVEN INTO
THE SPRING OF LATE CONGRESS HAS
FACED ITS CHALLENGES GETTING
APPROPRIATIONS OUT EARLY IN THE
FISCAL YEAR AND IT IS WELL
COMMON THAT IT'S FEBRUARY,
MARCH, OR APRIL WHEN THINGS GET
RESOLVED.
IT TENDS TO BE MORE COMPLICATED
IN AN ELECTION YEAR WHICH WE ARE
IN AND SO, THAT'S, YOU KNOW THE
STRUGGLE AND UNCERTAINTY WE FACE
BUT THAT'S WHAT'S PENDING IN
CONGRESS AND IT ENTIRELY
REFLECTS WHAT DR. BARKER SAID,
IT IS A KEEN COMMITMENT TO THE
WORK WE DO AT NCI, AND TO THE
NEEDS OF CANCER DISCOVERY AND
CANCER PATIENTS, WE'VE SEEN
THAT, IF YOU JUST LOOK ACROSS
THE YEARS, YOU KNOW, OTHER THAN
MANY YEARS THAT THERE'S BEEN
BELT TIGHTENING, IN GOVERNMENT
IN GENERAL ACROSS THE 9 FISCAL
YEARS WE'RE LOOKING AT HERE, BUT
WE HAVE SEEN INCREASES,
MEANINGFUL INCREASES ACROSS THE
YEAR ENTIRELY REFLECTS WHAT
DR. BARKER MENTIONED PREVIOUSLY.
SO LET ME THEN MOVE ON TO THE
NEXT SLIDE WHICH WILL COMPARE,
THE FISCAL YEARS TO RECEIVE WHAT
THE GROWTH WAS FOR 2022 FROM
2024, IT WAS 5%, I'M GIVING YOU
THE NIH TOTAL AS WELL AND AT
7.6% INCREASE GROWING INTO 2022,
AT THE BOTTOM FOR NCI, THEY
CHALLENGED US, CONGRESS
CHALLENGED US TO INCREASE,
COMPETING AND CONTINUING GRANTS,
NONCOMPETING GRANTS AS WELL, YOU
KNOW IT'S CONTINUING GRANTS BY
150 MILLION, AND THAT'S A TARGET
WE'RE DETERMINED TO MEET IN 2022
AND WATCH IT CAREFULLY AND
EVERYTHING SEEMS TO BE ON PATH
TO DO JUST THAT FOR NCI FOR
FISCAL YEAR 2022.
FOR 2023, WE SEE 2 APPROACHES
HERE FOR THE HOUSE AND THE
SENATE AND FOR NCI AND NIH, THE
HOUSE A BIT MORE GENEROUS, 6.7%,
THAT CERTAINLY IS GENEROUS BUT
THE SENATE IS SIMILARLY
GENEROUS, 4.2% AND WE'RE
WATCHING THOSE 2, IF THEY WERE
TO SIMPLY SPLIT THE DIFFERENCE
IT WOULD BE ABOUT A
375 MILLION-DOLLAR INCREASE.
WE HAVE TO SEE IF THAT'S WHAT
THEY DO AND IF THEY WERE
FAVORABLE OR UNFAVORABLY FOR
BUDGETS FOR THE NIH OR NCI IN
PARTICULAR.
AND SO, THERE YOU SEE HOUSE AND
SENATE NUMBERS FOR 2023 AND
WE'RE WATCHING ALL OF THAT AND
TRYING TO GET THE BEST OUTCOME
FOR NCI, LET ME MOVE TO THE NEXT
SLIDE, PLEASE.
ARP A H UP, I'M HERE AND I'M
DISPLAY THAGOREAN INFORMATION AS
WELL AND I'M DOING IT IN 2 WAYS,
WHAT THE DOLLAR AMOUNT WAS AND
WHO MANAGES THE PROGRAM AND SO
IN 2022, IN THE END IT WAS
SOMETHINGED BY NIH BUT
ORIGINALLY THE AUTHORITY WAS
GIVEN TO THE SECRETARY WITH
AUTHORITY TO DELEGATE TO NIHR
WHICH THE SECOND DID EXERCISE
AND THE OMOUNT WAS A MILLION
DOLLAR FOR ARP,A H, 2023, WE SEE
HOUSE AND SENATE ARE PROPOSING
DIFFERENT TOTALS, CONSIDERABLY
LESS THAN WHAT THE
ADMINISTRATION WANTED AT 5
BILLION AND WE ONCE AGAIN SEE, A
BACK AND FORTH CONSIDERATION
ABOUT WHERE ITS HOME SHOULD BE,
THE HOUSE, DELEGATES IT TO HHS
AND THE AND THE SENATE HAS IT
STAYING AT NIH, SO, IT'S ANOTHER
WATCH AND WAIT AND SEE.
AS TO WHERE THIS WILL GO, WHY WE
TALK ABOUT ARP A H BECAUSE WHEN
IT WAS FRAMED BY THE PRESIDENT
AND CONTINUES TO BE DISCUSSED
BUSINESS CANCER, THE NEEDS AND
THEY'RE CHARGED WITH ADVANCING,
AND THAT'S WHY IT WILL RELATE TO
THE WORK OF THE NATIONAL CANCER
INSTITUTE, WE'RE HAVING
DISCUSSIONS, WORKING TO FRAME UP
IDEAS THAT WILL BE SUITABLE FOR
AN RARP A H TYPE PROJECT RELATED
TO CANCER; AND THAT'S ALL FOR
THIS SLIDE, I LET ME MOVE ON
ONCE AGAIN AND I WILL MOVE TO
2024 NEXT, ASK BUT LET ME JUST
STOP AND SEE IF THERE'S ANYTHING
AT THIS JUNKT THAT YOU ARE
ANYONE WANTS TO JUMP IN WITH AND
I WILL MOVE ON TO 2024.
>> SO PATRICK CAN YOU SAY A BIT
MORE AND MK MAY TALK ABOUT THIS
IN HER LEGISLATIVE UPDATE BUT
CAN YOU SAY A BIT MORE ABOUT THE
THINKING AND MAYBE THIS IS A
2024 DISCUSSION, BUT,
CONSIDERING THE MOON SHOT FUNDS
THAT WE WILL EXPEND IN 2023, AND
WE'RE LOOKING AT A SIGNIFICANT
DEFICIT THEN UNLESS SOMETHING
HAPPENS, IS THERE A DISCUSSION
OF THAT AS PART OF EITHER THE
SENATE OR THE HOUSE'S
DELIBERATIONS AT THIS POINT OR
HAS IT COME UP?
>> WELL, YOU MAKE 2 GOOD POINTS,
TECHNICALLY NO, BECAUSE THEY'RE
DISCUSSING THE FINAL YEAR SO
THEY WOULD NEED TO ACTOT 2024
BUDGET AND OF COURSE THE
ADMINISTRATION WILL FRAME AND
PROPOSE A 2022 BUDGET, SO
WE--BOTH BILLS HAVE THE FULL
AMOUNT, 216 MILLION WHICH IS THE
FINAL INSTALLMENT OF 70 YEARS OF
MOON SHOT, THE FIRST MOON SHOT,
AND WE FULLY EXPECT THAT BECAUSE
THEY EVERY YEAR WITHOUT FAIL
ACROSS THE PRIOR 6 YEARS WE'VE
GOTTEN THE FULL DESIGNATED
AMOUNT AND WE DON'T SEE ANY
REASON WHY THEY WON'T DO THE
SAME BUT IT'S A STEP AHEAD TO
CONSIDER WHAT THEY WILL DO FOR
2024 AND MAYBE WE CAN DISCUSS
THAT MORE AT THE NEXT SLIDES BUT
WE KNOW THAT THERE IS HIGH
CONSCIOUSNESS ABOUT THAT, WE'VE
CALLED THAT A PARTIAL CLIP
BECAUSE THERE ACTUALLY WAS A
REDUCTION IN MIDPOINT GOING FROM
400 MILLION IN FY2019 DOWN THE
NCI MOON SHOT DOLLARS DOWN TO
195, THERE ABOUTS IN FY2020, SO
SO WE DID FAKE THAT AND CONGRESS
DID STEP IN AND RESOURCE THE NCI
BUDGET SUCH THAT WE REALLY HAVE
THAT LOSS, THE MONITOR SHOT IS A
DESIGNATED AMOUNT SO THEY DIDN'T
INCREASE IT IN MOON SHOT BUT
THEY GAVE US THE REDUCTION
AMOUNT IF YOU WILL IN OUR
REGULAR BUDGET SO WE WERE MADE
WHOLE, IT'S A SUMMATION OF WHAT
I JUST SAID, SO WHY KNOW THERE'S
A LOT OF CONSCIOUS ABOUT IT AND
WE KNOW THEY WON'T MISTAKE IT
AND FORGET ABOUT BUT WE HAVE TO
WATCH THAT ROLL OUT IN THE
COMING ADMINISTRATION'S BUDGET
IN 2024 FISCAL YEAR.
>> INDEED, ANY RECOLLECT
QUESTIONS FOR PATRICK UP TO THIS
POINT?
>> DONE YOUR USUAL GOOD JOB
PATTIC.
LET'S GO ON.
LET'S GO ON TO THE NEXT SLIDE,
BRIEFLY, JUST FRAMING UP, I'M
MOVING ON TO 24 WHICH I ALREADY
TOLD YOU SO WE CAN GO 1 MORE
SLIDE, PLEASE.
AND AND HERE WE ARE, THAT'S THE
SECOND OF FEBRUARY, IN 2022 IN
THE EAST ROOM OF THE WHITE HOUSE
AND THE PRESIDENT ANNOUNCING HIS
CANCER MOONSHOT, AND YOU KNOW I
WILL DIGRESS FOR A MOMENT IF YOU
WILL AND JUST TALK ABOUT THIS
WEEK, WE MAY BE SEEING THE FIRST
RETURN TO, YOU KNOW SPACE
DISCOVERY HEADING TO THE MOON
WITH ARTEMIS, ANDY WOO KNOW THAT
APOLLO WAS MODEST RELATIVE TO
ARTEMIS, AND WE SEE HERE
SIMILARLY THE SUPERCHARGE MOON
SHOT THAT THE PRESIDENT
ARTICULATED IS FAR BOLDER AS
ARTEMIS'S, AND AN ANALOGY I'M
USING AND I THINK IT FITS IN
SOME WAYS AND IT'S, YOU KNOW THE
GOALS HERE ON THE SLIDE THAT THE
PRESIDENT ARTICULATED REDUCING
AGE JUSTED DEATH RATE FROM
CANCER BY AT LEAST 50% AND THEN
TRANSFORMING THE MEANING OF
CANCER WHICH INCLUDES IMPROVING
THE EXPERIENCE OF PEOPLE LIVING
WITH CANCER, SURVIVING CANCER
AND THEN ADDRESSING CANCER
HEALTH DISPARITIES BY MEETING
THE NEEDS OF UNDERSERVED, THESE
ARE ALL BIG CHALLENGES THAT THE
SUPERCHARGE MOON SHOT IS TAKING
ON AND WE REALLY WATCH AND WAIT
TO SEE HOW IN THE 2024 BUDGET
WILL BE RESOURCED, NOT NCI ALONE
BUT OF COURSE, WITH A FLAG SHIP
ON BIOMALRESEARCH AND CANCER
SCIENCE, SO WE WILL WATCH AND
SEE HOW THAT THAT COMES FORWARD
IN THE BUDGET THAT'S HOW BEING
FRAMED, NEXT SLIDE, PLEASE,
HOWEVER I WANT TO SAY THAT YOU
KNOW WE'RE NOT BY NO MEANS IDLE,
WE ARE DEEPLY ENGAGED AND YOU
KNOW WE HAVE INITIATIVES WE'RE
START NOTHING 2023, 2 OF THESE
WERE RFAs THAT CAME BEFORE THE
JOINT MEETING IN JUNE AND THE
FIRST WAS MOON SHOT SCHOLARS,
THE SECOND WAS INITIATIVE, RFA
INITIATIVE IN MULTICANCKER
DETECTION TESTS AND BOTH OF
THESE WERE CLEARLY BROUGHT FORTH
AND FIT PERFECTLY WELL WITHIN
THE GOALS AND PRIORITIES OF THE
ADMINISTRATION FOR THE SUPER
CHARGE MOON SHOT, MANAGING AT
THE MEETING THE PRESIDENT
ANNOUNCED THE FORMATION OF A
CANCER CABINET WHICH NCI HAS A
SEAT ON AND SOON THEREAFTER, A
MONTH OR AFTER AT THE FIRST
MEETING OF THE CANCER CABINET,
THE CANCER CABINET AMONG THEIR
ANNOUNCEMENTS, NOT JUST THE ONLY
1 WAS THEIR CANCER MOONSHOT
SCHOLARS PROGRAM SO WE HAD THAT
BEING FRAMED UP AND WE BROUGHT
THAT TO THE JOINT BOARD MEETING
AND THE BSA ASCENTED AND SO
THAT'S 1 AND YET ANOTHER IS THE
EARLY DETECTION.
EVALUATION, EARLY DETECTION
TESTS, SO, I JUST WANT TO JUST
PAINT THE PICTURE THAT WE'RE--I
GUESS, PERHAPS, ARTEMIS'S IS NOT
GOING TO THE MOON BUT IT'S
MAKING READY, AND HERE WE ARE
MAKING READY AND WE'RE
OPERATIONALIZING THESE AND OTHER
THINGS SO THAT WE'RE WELL
POSITIONED NOT JUST IN THESE 2
AREAS, THESE ARE 2 GOOD
EXAMPLES, BECAUSE OF OF ACTIVITY
THAT YOU'VE SEEN IN PRIOR MONTHS
BUT THESE ARE THE KINDS OF
THINGS THAT WE'RE ENGAGED IN SO
THAT WE CAN MAKE THE SUPERCHARGE
MOON SHOT, THE SUCCESS THAT WE
HOPE IT TO BE AND TO ACHIEVE
THOSE BOLD GOALS THAT THE
ADMINISTRATION ARTICULATED.
AND THAT'S WHAT I CAN SAY MORE
OR LESS ON 2024, IT'S NOT ALL
ABOUT MOON SHOT, WE HAVE THE
BASE BUDGET WE'RE DEFENDING AND
1 OF THE THINGS WE'VE BEEN
SAYING IS THAT, YOU KNOW THE
ADMINISTRATION AND WE HAD LIKE
MANY WANT TO MOVE BOLDLY
FORWARD, BUT WE CAN'T LOSE
GROUND ON OUR BASE BUDGET
ANALOGY IS SOMEWHAT, YOU
KNOW--WILL BE 2 STEPS FORWARD
WITH SUPER CHARGED MOON SHOT AND
1 STEP BACKWARDS IF WE CAN'T
MAINTAIN THE BASIC RESEARCH AND
OTHER AREAS OF RESEARCH IN OUR
BASE BUDGET THAT WE NEED TO
SUSTAIN BECAUSE THOSE WILL MAKE
THE CONTRIBUTIONS JUST AS THE
SUPER CHARGED MOON SHOT WILL
WILL MAKE THE CONTRIBUTIONS TO
ACHIEVE THOSE GOALS.
IT'S NOT ALL DRIVEN EXCLUSIVELY
BY SUPER CHARGED MOON SHOT,
THERE ARE ONGOING INVESTMENTS
THAT CONTINUE TO DELIVER RESULTS
THAT YOU AND SO MANY ARE
FAMILIAR WITH.
THAT'S MY LAST SLIDE.
YOU COULD MOVE TO QUESTIONS FROM
THE SUBCOMMITTEE.
>> WELL IF YOU HAVE QUESTIONS
JUST PUT YOUR HAND UP.
OTHERWISE I WILL ASK QUESTIONS.
JOHN ARE YOU WANTING TO ASK A
QUESTION?
THERE YOU GO.
>> NO QUESTION FROM JOHN.
>> YEAH, THANKS, ANN.
BUDGET AND PLANNING I CAN'T HELP
BUT WONDER A BIT MORE ABOUT THE
MOON SHOT AND THE PLANNING FOR
IT AND I KNOW WE ORIGINALLY
THERE WAS A BLUE RIBBON PANEL
AND YOU KNOW A LOT OF THE
RECOMMENDATIONS WERE DEVELOPED
AROUND THAT COLLECTION OF
INDIVIDUALS AND JUST TRYING TO
FIGURE OUT HAS THERE BEEN ANY
THOUGHT OR DISCUSSION INTO WHAT
THE PROCESS WILL BE?
WILL IT BE THE SAME PROCESS?
OR WILL IT BE I'M ASSUMING WITH
THE CANCER CABINET, I WOULD
ASSUME IT'S NOT GOING TO BE THE
SAME.
IT WOULD BE AT LEAST DIFFERENT
BUT HAVE YOU HEARD OF ANYTHING,
HAVE YOU HEARD OF DOUG OR DANA
OR ANYONE HAS ANY IDEA HOW THE
PRIORITIES WILL BE SET, HOW
MECHANISMS WILL BE DEVELOPED?
IT MIGHT BE TOO PREMATURE, I'M
JUST WONDERING THOUGH?
>> JOHN, WHY DON'T I STEP IN.
GREAT QUESTION.
CERTAINLY THERE IS GOING TO BE
MORE INVOLVEMENT IF YOU WILL OF
GOVERNMENT BEYOND WHAT IT WAS
FOR THE MOON SHOT, PROBABLY WITH
FUNDING AS WELL AS IN TERMS OF
OTHER OPPORTUNITIES BUT AS I
WILL POINT OUT IN MY REMARKS
DURING THE REGULAR PART OF THE
MEETING, THE NCI AND THE FDA ARE
REALLY THE ONLY GROUPS OR
AGENCIES THAT ARE INVOLVED IN
CHANGING STANDARD OF CARE AND I
THINK THAT THIS ACTUALLY IS A
CRITICALLY IMPORTANT WAY OF US
NOT JUST TO POSITION OURSELVES,
BUT TO TRY TO HELP PATIENTS WITH
CANCER BECAUSE, YOU KNOW THE
PRESIDENT ARTICULATES TRYING TO
END CANCER AS WE KNOW IT AND AS
PATRICK POINTS OUT DECREASING
MORTALITY RATES BY 50% OR MORE,
BUT IF WE DON'T--IF WE CAN'T
HELP PEOPLE WITH PANCREATIC
CANCER AND OTHER CANCER TYPES,
WHICH WE DON'T HAVE A GOOD
OUTLOOK, WE REALLY NOT GOING TO
BE ENDING CANCER AS WE KNOW IT.
>> YOU KNOW DOUG, YOU ARE SO
RIGHT ON.
I MEAN, I THINK THAT'S EXACTLY
THE RIGHT ANSWER BECAUSE IF YOU
LOOK AT WHAT THIS PRESIDENT SAID
TIME AND TIME AGAIN, IT'S THAT.
HOW DO WE GET THE BEST STANDARD
OF CARE FOR EVERY PATIENT?
>> DINA MAY WANT TO COMMENT IN
ADDITION.
>> YEAH, BUT BEFORE THAT, I JUST
WANT TO SAY I THINK YOU KNOW
PERHAPS IT'S TIME TO REENVISION
THE WHOLE CONCEPT OF STANDARD OF
CARE.
I THINK STANDARD OF CARE
CURRENTLY SITS WITHIN THE HELT
CARE SYSTEM, SO THAT'S WHEN THE
PATIENT IS IN THE SYSTEM BUT SO
MANY PEOPLE DON'T GET IN THE
SYSTEM.
THEY DON'T GET IN THE SYSTEM
EARLY ENOUGH, RIGHT?
THEY'RE COMING IN WITH LATE
STAGE DISEASE AND I THINK NA'S
AN IMPORTANT ASPECTS TO REDUCE
MORTALITY RATES, AND I KNOW IT
MIGHT BE PREMATURE TO HAVE THESE
DISCUSSIONS BUT I JUST THINK,
YOU KNOW MAYBE WE NEED TO MOVE A
LITTLE BIT OUTSIDE OF THE BOX AS
WE THINK ABOUT THE NEXT STEPS.
>> JOHN, YOU ARE PREACHING TO
THE CHOIR.
WE ARE LOOKING AT HOW WE CAN
HELP WITH IMPLEMENTATION
RESEARCH BECAUSE MY PERSPECTIVE
IS THAT THE BIDEN ADMINISTRATION
GOALS ARE ASPIRATIONAL AND OUR
JOB IS TO TRY TO MAKE THEM
FEASIBLE AND TO ESSENTIALLY
EXPRESS HOW WE MIGHT BE ABLE TO
DO THAT.
>> AND I THINK ALSO JOHN, YOU
KNOW THE PROCESSES BY WHICH WE
CHANGE STANDARD OF CARE ARE
PRETTY ARCANE TO BE HONEST SO IT
WOULD BE GOOD TO SEE THOSE PRO
SESESS REVISITED IN THIS NEW ERA
AND I THINK THERE ARE A LOT OF
THINGS THAT YOU MADE A REALLY
GOOD POINT THEY THINK ISN'T
REALLY COMING THROUGH IN TERMS
OF THE RHETORIC THAT WE SEE IN
WHAT'S GOING ON WITH THE MOON
SHOT.
DINA DID HAVE YOU A COMMENT?
>> NO, I JUST WANTED TO FOLLOW
UP ON JOHN'S QUESTION ABOUT THE
PROCESS AND MAKE THE DISTINCTION
BETWEEN THE FIRST MOON SHOT AND
THE SUPER CHARGED MOON SHOT.
THE MOON SHOT 1.0, IF YOU WILL
WAS REALLY VERY FOCUSED ON
ACCELERATING CANCER RESEARCH, IN
THOSE AREAS THAT COULD BE
ACCELERATED AND SO THE BLUE
RIBBON PANEL WAS ASSEMBLED TO
HELP DEFINE WHAT THOSE AREAS
WERE AND THEN WE'VE BEEN ACTING
ON THAT EVER SINCE.
IMPLEMENTATION SCIENCE WAS A
LARGE PIECE OF THAT BUT IT
WASN'T THE ONLY PIECE AND I
THINK WITH THE SUPERCHARGED MOON
SHOT WE'RE SEEING A SHIFT MUCH
MORE TO THE IMPLEMENTATION
SCIENCE, THE ISSUES OF
HEALTHCARE DELIVERY SO THAT I
THINK MUCH OF IT WILL BE BEYOND
NCI AND FDA RESEARCH, ALTHOUGH
WE WILL BE AN INTEGRAL PART OF
IT AND OBVIOUSLY HAVING TO LEAD,
SO THE RESEARCH COMPONENT.
>> SO, JOHN, I THINK IT'S
INTERESTING, EVERYONE, I KNOW
THE ADVOCACY COMMUNITIES ARE
PAYING GREAT ATTENTION TO THIS
NOW.
THE OTHER THING THEY'RE PAYING
ATTENTION TO IS THIS ISSUE OF A
NUMBER OF GRANTS THAT NCI'S
RECEIVING AND CONTINUES TO
RECEIVE VERSUS, AND I'M NOT
SAYING THIS WITH ANY TERRITORIAL
INTENT BUT YOU KNOW IT'S
PROBABLY 10 TIMES IN MANY CASES
WHAT SOME OF THESE OTHER GROWNS
ACTUALLY RECEIVE AND WE HAVE TO
ACKNOWLEDGE THAT AT SOME POINT.
WE HAVE A COMMUNITY, AN
ENTERPRISE THAT WE BUILT THAT IS
QUITE WILLING AND READY TO
REALLY GO TO WORK TO CHANGE
THESE PARADIGMS, BUT YOU KNOW
THEY HAVE TO HAVE RESIEWRSS AND
SO THIS IS CERTAINLY ONLY 1
SOURCE OF THEM, BUT IT'S A BIG
WOB.
AND SO I'M--I'M A LITTLE
CONCERNED RIGHT NOW THAT WE, YOU
KNOW THAT--WE HAVE GOTTEN THE
ATTENTION THOUGH OF FOLKS OUT
THERE WHO ARE ADVOCATING ON OUR
BEHALF AND YOU SEE THAT NOW, IN
THIS--IN THESE BUDGET TOURS THAT
PATRICK PRESENTED AND A LOT OF
IT HAS TO DO WITH MAKING CLEAR
THAT THESE PAY LINES ARE
SUFFERING BECAUSE PEOPLE HAVE
TALENT AND INTEREST IN APPLYING
TO NCI FOR SUPPORT, AND SO, YOU
KNOW IF WE PASS--IF WE PASS,
THEN,S YOU KNOW A LOT OF YOUNG
PEOPLE ARE GOING TO GO TO
ANOTHER--YOU KNOW THEY'RE GOING
TO OPEN A BAKERY OR SOMETHING.
SO NOT QUITE SURE WHAT THEY'LL
DO BUT THEY'RE LOOKING FOR WORK
OBVIOUSLY AND IT'S REALLY SAD.
I JUST REALLY WANT US TO DO MORE
ABOUT THIS.
SO, OTHER QUESTIONS?
YES, KAREN?
>> YES, I JUST WANTED TO GO BACK
TO THIS ISSUE ABOUT CANCER
DISPARITIES AND 1 OF THE THINGS
THAT WAS MENTIONED IS, YOU KNOW
THAT ACCESS ISSUES.
WE CAN FUND ALL THE
IMPLEMENTATION SCIENCE THAT WE
WANT TO BUT IF PEOPLE DON'T HAVE
THE INSURANCE, THE RIGHT
INSURANCE TO ACCESS THE
HEALTHCARE, THAT'S A PROBLEM,
RIGHT?
AND I UNDERSTAND THAT THAT'S NOT
WHAT THE NCI DOES AND I THINK WE
HAVE TO BE VERY CLEAR MINDED TO
TELL PEOPLE, THE NCI FUNDS
RESEARCH, RIGHT?
INCLUDING IMPLEMENTATION
RESEARCH, BUT ALSO PROVIDES
DOLLARS TO COMPREHENSIVE CANCER
CENTERS AND THERE ARE SO MANY
COMPREHENSIVE CANCER CENTERS
THAT DO NOT ACCEPT MEDICAID AND
THAT'S SOMETHING THAT WE NEED TO
THINK COLLECTIVELY ABOUT, ABOUT
HOW DO WE DO THAT?
WHAT'S THE POLICY LEVERAGE WE
CAN PULL THAT CAN REALLY HELP TO
MAKE SURE THAT IF WE ARE GOING
TO FUND RESEARCH TO
INSTITUTIONS, THAT THOSE SAME
INSTITUTIONS OPEN THEIR DOORS TO
EVERYONE OTHERWISE THOSE
DISPARITIES WILL CONTINUE TO
WIDEN.
>> THAT'S AN EXCELLENT POINT AND
1 THING YOU WILL NOTE WHEN THE
BUDGET'S--ACTUALLY PATRICK MAY
KNOW ABOUT THIS BUT I KNOW
THERE'S A SIGNIFICANT INCREASE
IN THE 2023 BUDGET, I BELIEVE
FOR CDC THIS YEAR, AND CDC IN
PARTNERSHIP OFTEN WITH NCI IN
THE PAST HAS TRIED TO ADDRESS
JUST THIS ISSUE.
YOU RECALL THE ISSUE ON
SCREENING AND IT WERE BREAST
CANCER YEARS AGO, YOU KNOW WE
GOT EVERYBODY'S ATTENTION TO
SCREENING BUT NO 1 WANTED TO PAY
FOR IT.
SO ADVOCATES WENT BACK TO
CONGRESS AND ESSENTIALLY GOT
THAT BILL PASSED BUT, I THINK
YOU'RE ABSOLUTELY RIGHT.
IT'S VERY--WE KNOW IT'S A HARD
PROBLEM, RIGHT?
BUT YOU KNOW THERE ARE SOLUTIONS
TO THIS PROBLEM, WE SHOULD GET
ON WITH IT.
SO THANK YOU FOR THAT.
ANY OTHER COMMENTS ON THE
BUDGET?
SO I'M ALWAYS LOOKING FOR OTHER
OPPORTUNITIES AS WELL BECAUSE
NCI SUBJECT THE ONLY SOURCE OF
FUNDING AND EVERY TIME WE MAKE
AN INVESTMENT, IT RIEWCIALLY
ALLOWS THAT INVESTMENT TO
MULTIPLY BUT I WAS CURIOUS
PATRICK AND IF MK MIGHT SAY
SOMETHING ABOUT THIS PACT ACT,
PACT ACT, PASSED JUST 2 WEEKS
AGO.
AND THIS IS AN ACT, IF YOU
WEREN'T PAYING ATTENTION, IT'S
IT'S A REALLY INTERESTING
APPROACH, I THINK FOR VETERANS
WHO WERE ACTUALLY, I THINK
EXPOSED TO ANYTHING, ANYWHERE
ESPECIALLY IN IRAQ, IRAN, ET
CETERA ALL THOSE TERRIBLE AREAS
OF THE WORLD THAT HAVE, YOU KNOW
WHERE THEY'VE BEEN EXPOSED TO
BURN PITS AND LOTS AND LOTS OF
OTHER TERRIBLE TOXIC MATERIALS.
THAT ACT IS ACTUALLY GOING TO
GUARANTEE VETERANS ESSENTIALLY
CARE BUT IT ALSO IS PROVIDING, I
THINK FUNDING FOR RESEARCH AND I
MEAN IT KIND OF OPENS UP A WHOLE
NEW OR REVISITS AN AREA OF
CANCER RESEARCH THAT'S BEEN KIND
OF LANGUISHING FOR YEARS AND
THAT IS, YOU KNOW COMPLEX
CARCINOGENS THAT PEOPLE ARE
EXPOSED TO, ESPECIALLY FROM
THESE PARTICULAR MILITARY
ACTIVITIES AND SO, I DON'T KNOW
PATRICK IF WE KNOW ANYTHING
ABOUT THAT ACT IN TERMS OF HOW
IT MIGHT IMPACT US?
I KNOW THERE WAS A MEETING, I
KNOW THAT DR. SCHRIEBER CONVENED
A FEW WEEKS AGO AND NCI WAS
REPRESENTED THERE SO I DON'T
KNOW IF WE KNOW ANYTHING MORE
ABOUT IT OR NOT.
>> AND SO, I THINK I UNDERSTAND
WHAT YOU'RE SAYING, IT DOESN'T
HAVE A DIRECT IMPACT ON US,
HOWEVER, IT DOES IMPACT AN
IMPORTANT FIELD OF CANCER RISK
AND POTENTIALLY CANCER
PREVENTION AND MANY OTHER
THINGS.
SO AND OF COURSE, THIS IS AN
AUTHORIZATION ACT AND WE NEED TO
LOOK TO THE DEFENSE
APPROPRIATIONS BILL FOR
RESOURCES, BUT I DO KNOW THAT
EVEN PRIOR TO THIS BILL, IN
GETTING ENACTED, THERE WAS A
STEADY INCREASE IN FUNDING FOR
THIS FIELD WITHIN BOTH THE VA
AND THE DEPARTMENT OF DEFENSE.
THE DEFENSE OF DEFENSE HAS A
CANCER RESEARCH PROGRAM AND THIS
WAS ADDED AND ADDITIONAL
SPECIFIC DOLLARS WERE PUT INTO
THEIR RESOURCE POOL FOR CANCER
RESEARCH STARTING IT MAY HAVE
PREIDATED FISCAL YEAR 2021 BUT I
WATCHED IT GROW AND GROW AGAIN
IN 2022 SO AT NCI IS LOOKING TO
PARTNER WITH THE VA AND THE
D.O.D., I'M NOT SURE HOW THAT'S
GOING TO EVOLVE, DR. PHIL CASTLE
IS 1 OF THE 1S ENGAGED IT TRYING
TO BE SUPPORTIVE, BE
COLLABORATIVE, AND LEVERAGE
MUTUALLY THE RESOURCES AND
CAPABILITIES OF ALL 3 AGENCIES.
IT'S AN AREA TO WATCH AND AN
AREA OF OPPORTUNITY IS
FUNDAMENTALLY WHAT YOU'RE
SAYING.
>> I THINK IT'S AN OPPORTUNITY
BUT IT'S ALSO REALLY INTERESTING
OPPORTUNITY IN TERMS OF WHERE WE
ARE.
I MEAN MOLECULAR CAR SIN O
GENESIS WILL BE, YOU KNOW REALLY
REQUIRED HERE IN APPLYING SO
MANY OF THE THINGS THAT WE KNOW
HOW TO DO NOW THAT WE WOULDN'T
HAVE KNOWN HOW TO DO 10 YEARS
AGO AND I'M PRETTY SURE THAT
DR. SCHREIBER WOULD LIKE TO
ATTRACT PLANE OF OUR EXTRAMURAL
INVESTIGATORS TO WORK ON
PROGRAMS LOAMACYIC THIS BECAUSE
THIS WILL BE VERY SOPHISTICATED
SCIENCE BECAUSE THESE ARE VERY,
VERY COMPLEX MIXTURES THAT THESE
FOLKS HAVE BEEN EXPOSED TO.
SO WE NEED TO LACK AT THAT AND I
THINK, I THINK DR. SCHRIEBER IS
ON THE NCAB AS OUR VA
REPRESENTATIVE SO AT IN POINT IT
MIGHT BE GOOD TO BRIEF US ON
THIS IN TERMS OF WHAT HIS PLANS
ARE.
I HAD A--SO LET ME JUST MAKE
SURE THAT WE HAVE OTHER
QUESTIONS FROM THE SUBCOMMITTEE.
SO I HAVE A COUPLE QUESTIONS
THAT CAME IN FROM ME PATRICK AND
I DON'T WANT TO PUT YOU ON THE
SPOT SO YOU CAN PASS BECAUSE I
DEPARTMENT KNOW THAT I WOULD
HAVE THESE.
SO SOMEBODY ASKED ME AFTER OUR
LAST MEETING HOW DO WE NCI
CLASSIFY RESEARCH WHEN PEOPLE
ARE LOOKING TO FIND OUT HOW MUCH
IS SPENT ON EACH AREA AND ON
EACH, YOU KNOW PROSTATE CANCER,
BREAST CANCER, WHAT HAVE YOU
INDIVIDUALLY, HOW DO WE MAKE
THAT DETERMINATION?
IT'S A COMPLICATED ANSWER, I
KNOW, PATRICK.
>> WELL, THERE ARE A COUPLE OF
RESOURCES FOR IDENTIFYING THE
DOLLARS WE HAVE IN AREAS OF
RESEARCH.
NCI MANAGED 1 AND NIH MANAGES
ANOTHER AND NIH MANAGES IT
GLOBALLY BUT OF COURSE IT PICKS
UP ON CANCER GLOBALLY FOR ALL
NIH AND YOU KNOW I CAN FOLLOW UP
AND GET THE WEB LINKS TO THOSE
RESOURCES BUT THERE ARE
ESTABLISHED CAN COMPLEX
ALGORITHMS THAT WE WILL LOOK AT,
ABSTRACTS OF RESEARCH PROPOSALS
THAT WE FUND AND DETERMINE THE
WAITING IF YOU WILL, THE AREAS
OF RESEARCH THAT A PARTICULAR
AWARDED APPLICATION SEEKS TO
FUND AND THERE'S A FULL ENTIRE
PROCESS THAT MY OFFICE DOESN'T
TOUCH BUT WE DO GET FAMILIAR
WITH AND WE GET QUESTIONS FROM
TIME TO TIME AND WE REFER THEM
TO THOSE STANDING RESOURCES OF
INFORMATION, THIS HAS BEEN GOING
ON FOR MORE THAN A DECADE, AND
IT'S EVER GREEN, WE GET MORE
ROBUST, WHICH WE TRY TO IMPROVE
OUR PAIBILITY TO BE MORE
SPECIFIC AND FROM TIME TO TIME
WE ADD NEW CATEGORIES AS NEW
CATEGORIES EMERGE SUCH AS LIKE
CATEGORY WE JUST CITED WITH THE
PACT BILL.
SO THAT MIGHT NOT EVEN BEEN
FORMED ABOUT 5 OR 7 YEARS AGO
EXCEPT BY A FEW ADVANCED
THINKERS, THAT'S HOW IT WORKS.
CAN'T BE MUCH MORE SPECIFIC THAN
THAT BUT I CAN CERTAINLY FOLLOW
UP AND GET THOSE LINKS PASSED ON
TO THE MEMBERS OF THE
SUBCOMMITTEE AND MAYBE WE COULD
I GUESS IF IT'S ACCEPTABLE, WE
COULD PUT THOSE IN THE MINUTES.
>> THAT WOULD BE HELPFUL, I
GUESS MORE PEOPLE--WHEN THE
SYSTEM WAS DEVELOPED, I KNOW
IT'S A PRETTY COMPLEX SYSTEM BUT
IF YOU'RE LOOKING UP TO SEE HOW
MUCH YOUR PARTICULAR AREA OF
INTEREST IS BEING FUNDED, THERE
IS A MECHANISM THERE.
SO 1 OTHER QUESTION AND THIS MAY
BE SOMETHING FOR A LATER
SUBCOMMITTEE BUT YOU KNOW, HOW
DO WE AT NCI DETERMINE THE
PERCENTAGE OF OUR BUDGET THAT
GOES INTO RFAs VERSUS
EVERYTHING ELSE?
SO I DON'T KNOW IF WE ARE
PREPARED TO ANSWER THAT, IF
THEY'RE--BECAUSE IT'S NOT
NECESSARILY PROCESSED BECAUSE
IT'S NOT NECESSARILY DEPENDENT
OPPORTUNITY DEPENDENT IS THERE
ANY WAY YOU WANT TO TRY TO
ANSWER IT NOW OR TRY TO THINK
ABOUT IT.
>> I STARTED OFF AND MAYBE
OTHERS IN LEADERSHIP WANT TO
JUMP IN BUT WE'RE VERY
CONSCIOUS, WE HAVE A VERY
CONCERTED EFFORT TO INSURE THAT
THERE'S A PROPER BALANCE BETWEEN
RFA AND INVESTIGATOR INITIATED
FUNDED RESEARCH AND WE MEET AND
WE SET THRESHOLDS.
WE PREFER NOT TO EXCEED A
CERTAIN AMOUNT OF OUR COMPETING
GRANTS POOL IN RFAs, WE--IT
DOES EXPAND AND CONTRACT AT LIKE
THE 1% LEVEL ACROSS THE YEARS,
SOMETIMES WITH 1% BELOW,
SOMETIMES, I APOLOGIZE, 1% ABOVE
OUR TARGETED THRESHOLD BASED
KNOW SOME URGENCY OR ANOTHER,
AND SO, THERE'S A FULL PROCESS
THERE THAT WE GO THROUGH EACH
YEAR TO, I GUESS IT'S A GOLDY
LOCKS AND THE 3 BEARS, NOT TOO
MUCH, NOT TOO LITTLE, JUST
RIGHT, IS WHAT WE STRIVE FOR.
>> THAT'S RIGHT.
SO DO YOU WANT TO COMENLT ON
THAT?
, YEAH, WHY DON'T I JUST SAY
THAT WE WANT TO MAKE SURE THAT
ON THE 1 HAND THERE ARE RFAs
WHEN IT IS CRITICALLY IMPORTANT
TO HAVE THEM AND I ALSO WANT TO
TELL PEOPLE BECAUSE WE'RE
TALKING ABOUT BUDGETED, THERE
ARE MANY RFAs THAT ARE OUTSIDE
THE RPG POOL BUT RFAs THAT ARE
WITHIN THE RPG POOL, WE AIM FOR
THEM TO BE ON THE ORDER OF
10-15% FORT RPG POOL FOR EACH
YEAR.
WE WORRY THAT IF WE GO ABOVE
THAT PERCENTAGE, THAT TRUE
INVESTIGATOR INITIATED RESEARCH
WILL BE FURTHER CURTAILED
BECAUSE ON THE 1 HAND, WE ARE
SIPPINGINALLING WE THINK THIS IS
IMPORTANT BUT ON THE RECOLLECT
HAND, THE PRINCIPLE PURPOSE OF
THE RPG POOL IS FOR INVESTIGATOR
INITIATED RESEARCH.
>> DINAH, YOU HAVE ANYTHING TO
ADD?
>> ONLY A LITTLE.
I THINK WE USE RFAs VERY
THOUGHTFULLY AND THEY'RE MOSTLY
FOCUSED ON AREAS THAT ARE
EMERGING WITHIN OUR PORTFOLIO,
THAT WE REALLY THINK NEED TO BE
FACILITATED BY HAVING SET ASIDE
FUNDS BUT WE'RE VERY CAUTIOUS IN
USING THEM AS PATRICK SAID.
WE REVIEW THEM CRITICALLY AT
MULTIPLE LEVELS AND TRY TO KEEP
AS MUCH IN THE BUDGET FOR
INVESTIGATOR INITIATED RESEARCH
AS WE CAN.
>> I THINK EVERYONE KNOWS THE
RFAs ARE REVIEWED WITH SOME
TENACITY BY THE BSA AND THEY
ALWAYS HAVE THINGS TO SAY ABOUT
THOSE, SO IT'S--MONEY IS ALWAYS
SPENT VERY WISELY IN THAT
REGARD.
SO 1 OTHER CAVEAT, NOW WE TALKED
ABOUT THIS LAST TIME BUT--EXCUSE
ME--BUT DOUG I WAS WONDERING
SINCE I HAVE YOU IF YOU COULD
SAY A BIT MORE ABOUT THIS.
THIS MULTIDETECTION OF CANCER
AND YOU KNOW WE HEARD FROM PHIL
KASES EDUCATIONALY ON THIS AND
WE'RE HEARING EVERYWHERE NOW
THAT STARTED OBVIOUSLY WITH
METHYLATION BUT NOW IT'S MOVED
INTO ALL ASPECTS OF RNA AND EVEN
ALL THE WAY BACK TO DNA AND
THEY'RE NOW, YOU KNOW A MILLION
COMPANIES THAT ARE FORMING THIS
REGARD, SO DO YOU THINK WE'RE
PREPARED FOR THIS, I GUESS IN
TERMS OF OUR INFRASTRUCTURE AND
GETTING BACK TO STANDARD OF
CARE, TO JOHNS COMMENT, HOW DO
YOU SEE THIS GOING?
I MEAN--
>> ANN ARE YOU REFERRING TO THE
RESEARCH PART?
OR IT BECOMES STANDARD OF CARE
AND IS IT GOING TO BE THE WILD
WEST?
>> I DON'T KNOW AND I'M JUST
WONDERING, I MENTIONED LAST TIME
THAT MAKE WE NEED A COMMITTEE OF
THE NCAB TO LOOK INTO THIS.
BUT I JUST WONDER WHAT YOU'RE
THINKING?
>> WELL, WE FEEL THAT HAVING A
MORTALITY END POINT IS VERY
IMPORTANT.
THERE IS CONCERN THAT I MEAN WE
KNOW WE'RE GOING TO DETECT
ASYMPTOMATIC CANCERS, OKAY?
THE QUESTION IS, WILL WE EXTEND
LIFE?
AND I THINK THAT NCI IS REALLY
GOING TO BE REQUIRED TO DO THAT.
WE ARE GOING TO DO THAT AS WELL
AS WE CAN, BUT, I THINK THAT WE
SEE THAT IT REQUIRES A LOT OF
INFRASTRUCTURE BECAUSE THE
TRIALS ARE LARGE.
BECAUSE, YOU KNOW, GOOD NEWS IS
MOST PEOPLE DON'T HAVE CANCER.
SO YOU HAVE TO SCREEN A LOT OF
PEOPLE IN ORDER TO DETECT A
REASONABLE NUMBER OF CANCERS SO
YOU THEN CAN SAY, WELL, HOW ARE
WE DOING?
IN ADDITION AS YOU POINT OUT
THERE ARE MULTIPLE PLATFORMS SO
IT REALLY BECOMES A BIG PROBLEM.
JOHN YOU ARE NODDING YOUR HEAD,
SO IT'S A BIG PROBLEM.
>> IT'S A BIG PROBLEM.
>> IT'S A BIG PROBLEM BUT DO WE
ASSESSMENT TO STANDARDIZE OR DO
WE FALL INTO A SITUATION WHERE
THERE ARE GOING TO BE HOME BREW
LABORATORY DEVELOPED TESTS
VERSUS THOSE THAT MIGHT BE MORE
STANDARDIZED TESTS THROUGH A
SPECIFIC VENDORS AND IT'S GOING
TO BE A REALLY, REALLY
COMPLICATED SITUATION.
>> I THINK RARELY HAVE WE SEEN
SOMETHING THAT COULD BE A
PARADIGM SHIFT AND WE HAVE TO
FIGURE THIS OUT AND I THINK WHAT
YOU'RE GOING TO DO HERE, DOUG IS
VULNERABLE IN TERMS OF WHAT HAS
TO BE DONE BUT I'M HOPING THAT
NCI GETS A LOT OF VISIBILITY FOR
DOING THE TRIALS BECAUSE I THINK
YOU'RE RIGHT, THE END POINT HERE
HAS TO BE, ARE WE GOING TO SAVE
ANY LIVES THIS WAY?
AND IT'LL BE EASY TO FIND STAGE
4 CANCER, I MEAN THAT WON'T BE
ANY KIND OF A STRETCH BUT THOSE
PEOPLE THAT ARE, YOU KNOW, VERY
EARLY STAGE AND YOU'RE DETECTING
A SIGNAL, NOT NECESSARILY
DETECTING ANYTHING THAT WOULD BE
CANCER AND SOME OF IT MAY BE
ABSOLUTELY A SIGNAL FOR NOTHIN.
SO IT'S A COMPLEX ISSUE BUT THEY
HAVE JUST FINISHED ENROLLING IN
THE UK TRIAL A FEW WEEKS AGO SO
THAT'S 150,000 PEOPLE I THINK,
SO, YOU KNOW THEY WILL HAVE--WE
WILL HAVE A FIRST DATA POINT AND
WE WILL SEE, YOU KNOW WHAT THAT
SAYS, BUT I--PEOPLE ARE SELLING
THIS STUFF ALREADY TO JOHNS
POINT, THEY'RE SELLING IT AND
THEY WILL CONTINUE TO SELL IT
UNDER CLEA BUT I THINK IT'S--I
THINK IT'S SOMETHING WE REALLY,
REALLY NEED TO PAY ATTENTION TO
SO I THANK YOU FOR ALL THAT
YOU'RE DOING ON THIS.
>> AND ANN AS IMPORTANT AS THE
UK TRIAL IS, IT'S END POINT IS
NOT A MORTALITY END POINT.
>> NOT MORTALITY.
>> SOUND STAGING.
>> YEAH, AND DOWN STAGING IS
IMPORTANT, DON'T GET ME WRONG,
THAT'S IMPORTANT.
THAT WILL SAVE LIVES, I THINK.
BUT DOUG, WHILE I HAVE YOU AND
WE'RE ANSWERING SOME OF OUR
QUESTIONS, I KNOW WE HAVE
ANNOUNCED THAT WE HAVE A--WE
HAVE A CANDIDATE DIRECTOR FOR
NCI, CAN YOU SAY SOMETHING ABOUT
THE PROCESS.
>> SURE AND I'M GOING TO SAY
SOMETHING IN MY REMARKS.
SO CAN YOU SOMETHING TO US, TOO.
>> THE WHITE HOUSE NAMED MONICA
BERTENOLLI, OUTSTANDING
PHYSICIAN SCIENTIST IN BOSTON.
AND WE'RE LOOKING FORWARD TO HER
COMING AS SOON AS SHE CAN BE
VETTED AND APPOINTED.
>> WELL, WE ALL KNOW MONICA AND
YOU'RE RIGHT, SHE WILL BE--SHE'S
A FINE CHOICE.
BUT I WANTED TO JUST ON BEHALF
OF MYSELF AND THE COMMITTEE, AND
I'M PRETTY SURE THE WHOLE NCAB,
YOU ARE SUCH A DEDICATED,
WONDERFUL PUBLIC SERVICE ANT, IF
I PUT UP A BOX THAT SAID PUBLIC
SERVANT, IT WOULD HAVE YOUR
PICTURE ON IT SO ANYWAY, WE LOVE
YOU AND WE REALLY THINK YOU'VE
DONE A INGREDIENT JOB FOR US.
SO THANK YOU.
>> YOU KNOW, THE NCI IS FAR TOO
IMPORTANT NOT TO MAKE CRITICAL
DECISIONS AS WE GO, AS WE GO
ALONG.
AND AS I SAID LAST TIME IN JUNE,
THAT I MADE THE JOKE THAT WE
NEED TO CHANGE THE NAME IN NCI
TO NCB,.
>> THAT'S FUNNY, BUT ON BEHALF
OF THE SUBCOMMITTEE YOU ANSWER
OUR QUESTIONS AND HAVE BEEN VERY
KIND TO ALWAYS KEEP US INFORMED
SO WE REALLY DO APPRECIATE IT
AND WE WILL LOOK FORWARD TO IT.
>> THANKS FOR ALL OF YOUR
INTEREST AND COMMITMENT, YOU
KNOW, YOU AND EVERYBODY ELSE ON
THE BOARD AND YOU KNOW I'VE BEEN
TALKING OFFLINE WITH JOHN ABOUT
YOU KNOW HOW YOU MIGHT BE ABLE
TO HAVE EVEN MORE AN IMPACT, YOU
KNOW NOT LOBBYING CONGRESS BUT
INSTEAD, YOU KNOW, HELPING US TO
DO AN EENCH BETTER JOB.
>> YEAH AND I TALKED TO JOHN
ABOUT THIS, AS PAULET KNOWS THIS
IS A COMMITTEE THAT COULD BE A
LOT MORE FUNCTIONAL, A LOT MORE
TO HELP THE NCI, WE CANNOT LOBBY
CONGRESS, IF YOU RAISE YOUR
CONFLICT OF INTEREST STATEMENTS,
YOU KNOW THAT'S NOT GOOD, YOU
CAN DO THINGS PERSONALLY, NCI
DOESN'T CONTROL THAT, BUT MANY
OF US DO, BUT, I THINK JOHN,
THAT'S SOMETHING HA IS REALLY A
DISCUSSION WE SHOULD HAVE
BECAUSE THERE ARE THINGS THAT WE
COULD DO TO HELP NOT JUST
THROUGH THIS SUBCOMMITTEE BUT
THE WHOLE OF THE NCAB.
>> YEAH, I SORT OF THINK OF THE
WORD REIMAGINE AND.
>> I HATE THAT WORD BUT OKAY.
>> BUT IT--AS WE THINK ABOUT THE
NCI-
>> JOHN.
>> WE'RE IN AN OPEN SESSION,
JUST WANT TO REMIND YOU SO CAN
YOU CHOOSE YOUR WORDS CAREFULLY.
>> OKAY.
>> YES, YES AND DON'T REIMAGINE
IT, THAT WORD IS SO OVERUSED
RIGHT NOW.
>> WELL I REMEMBER THE SAME
THING WHEN WE USED TO USE THE
WORD TRANSLATION.
>> THAT'S TRUE.
>> TRANSFORMATIONAL.
>> YEAH, TRANSFORMATION, THAT'S
THE OTHER WORD.
OKAY, I'M PART OF AN INSTITUTE
THAT HAS THAT IN ITS TITLE.
>> BUT I WANT TO ECHO ANN'S
COMMENTS ABOUT THE NCI AND THE
LEADERSHIP AND YOU KNOW IT'S AN
INTUITION, IT'S NOT A PERSON.
BUT YOU KNOW, DOUG, DINA AND THE
ENTIRE NCI IT'S BEEN FANTASTIC
AND WE REALLY LOOK FORWARD TO
SEEING EVEN MORE IMPACT GOING
FORWARD.
>> HERE HERE.
>> WELL, LISTEN, WE ARE JUST
ABOUT A MINUTE AHEAD SO I WILL
GIVE THAT BACK TO YOU ALL AND WE
WILL SEE YOU ON THE OTHER SIDE
IN ABOUT 5 MINUTES