>> A WARM WELCOME TO DR. DOUG
LOWY.
IT'S GREAT TO HAVE YOU AT THE
TOP OF THE HELM AND LOOKING
FORWARD TO YOUR COMMENTARY TOD
TODAY.
AND HAPPY THANKSGIVING TO
EVERYONE.
KEITH, I DON'T KNOW IF YOU HAD A
FEW OPENING REMARKS?
>> I'D LIKE TO ECHO YOUR WARM
WELCOME AND ESPECIALLY TO DOUG.
THIS IS THE SECOND TIME IN MY
TENURE THAT YOU HAVE STEPPED IN
TO GUIDE US THROUGH A TRANSITION
PERIOD.
SO, THANK YOU AGAIN AS ALWAYS
FOR YOUR STEADFAST COMMITMENT TO
KEEPING THIS ORGANIZATION
MOVING.
AND THIS IS MY LAST MEETING.
I'M SAD TO SAY.
AND WITH THAT, I'D LIKE TO
PARTICULARLY ACKNOWLEDGE
DR. PAULA GRAY.
I THINK YOU HAVE ALL HAD AN
OPPORTUNITY TO ADMIRE HER WORK
IN SUPPORT OF THESE BOARDS, BOTH
OF THEM.
OBVIOUSLY MY PERSPECTIVE WITHIN
THE BSA EXTENDS BACK INTO THE
BEGINNING OF MY TERM AND
PARTICULARLY THESE PAST TWO
YEARS WHERE I AND JOHN HAVE
GOTTEN TO WITNESS HOW IT IS THAT
PAULA WORKS BEHIND-THE-SCENES TO
REALLY MAKE THESE BOARDS WORK IN
THEIR INTEND PURPOSE.
PAULET YOU'RE THE CONSTANT
PROFESSIONAL.
I HAVE NEVER HAD THE HONOR OF
WORKING WITH SOMEONE WHO YOU IS
SO COMMITTED AND SO EXCELLENT IN
THEIR JOB.
YOU ARE THE INSTITUTIONAL MEMORY
AND KNOWLEDGE OF THIS
ORGANIZATION.
I CANNOT IMAGINE HOW THIS BOARD
WILL FUNCTION WITHOUT YOU.
BUT I'M VERY, VERY GRATEFUL FOR
YOUR HELP AND SUPPORT IN THIS
TIME.
LASTLY, I'D LIKE TO PASS THE
MICROPHONE TO KEN TO PROVIDE US
WITH A FEW THOUGHTS BEFORE WE
KICK OFF THE MEETING.
>> THANK YOU.
I WANTED TO SAY I'M GLAD TO BE
HERE.
I'M HERE AS A BSA MEMBER.
THIS THE IS MY LAST DAY AS CHAIR
AND TOMORROW I'LL BE A CANCER
BIOLOGY FACULTY MEMBER BEFORE I
MOVE UP HERE.
I'M GLAD TO BE LEARNING FROM
DOUG LOWY AND EVERYONE ELSE AND
I WILL BE VERY QUIET DURING THIS
MEETING.
I'M HERE TO SOAK IT IN TODAY.
SO THANK YOU FOR EVERYTHING THAT
EVERYONE DOES.
>> THAT'S GREAT.
I CONCUR WITH ALL OF KEITH'S
COMMENTS.
SO, REQUIRED ANNOUNCEMENTS.
MEMBERS OF THE PUBLIC WHO MAY
WISH TO EXPRESS VIEWS REGARDING
ANY ITEMS DISCUSSED DURING THE
MEETINGS MAY DO SO BY WRITING TO
DR. PAULA GRAY WHO IS THE
EXECUTIVE SECRETARY OF THE
BOARD, WITHIN 10 DAYS FOLLOWING
THIS MEETING B WRITTEN
STATEMENTS SUBMITTED BY MEMBERS
OF THE PUBLIC WILL RECEIVE
CAREFUL CONSIDERATION.
AS BOARD MEMBERS, I'D LIKE TO
REMIND YOU ALL THAT WE HAVE TO
ABSTAIN OURSELVES VIRTUALLY
DURING SPECIFIC DISCUSSIONS
WITHIN OUR PARTICIPATION AND
DELIBERATIONS ON A PARTICULAR
PRODUCT OR PROGRAM WOULD
CONSTITUTE A CONFLICT OF
INTEREST OR CREATE THE
APPEARANCE OR PERCEPTION OF ONE.
IT IS INCUMBENT UPON OURSELVES
TO ADVISE THE EXECUTIVE
SECRETARY AND ABSTAIN FROM
PARTICIPATION OR DISCUSSION OR
ACTION REGARDING THAT MATTER.
IN LIGHT OF THE CURRENT POLICIES
GOVERNING CONFLICT OF INTEREST
BASED ON FINANCIAL HOLDINGS OF
SPECIAL GOVERNMENT EMPLOYEES AND
AS BOARD MEMBERS, WE HAVE TO
DEPEND ON US TO VOLUNTARILY
ABSTAIN DURING ANY AND ALL
DISCUSSIONS OF MATTERS THAT
COULD CONCEIVABLY IMPACT THE
STATUS OF ANY OF THE HOLDINGS
DISCUSSED.
SO WE HAVE TO TRUST OUR JUDGMENT
IN THESE INSTANCES OF THE DURING
ANY CLOSED SESSION ANY MATERIALS
OR DISCUSSIONS OF A CONFIDENTIAL
NATURE ARE PRIVILEGED
INFORMATION AND ARE MADE
AVAILABLE ON A NEED TO KNOW
BASE, SUCH DELIBERATIONS ARE
PRIVATE AND THEIR CONTENT SHOULD
NOT BE DIVULGED.
SO FUTURE MEETING DATES ARE
LISTED ON THE AGENDA ANDOR THE
CANCER.GOV WEBSITE.
BY LAW, A QUORUM OF BOARD
MEMBERS IS REQUIRED WHETHER IN
OPEN OR CLOSED SESSION.
DURING THIS MEETING A MEMBER OF
24 APPOINTED MEMBERS MUST BE
PRESENT FOR THEIR VOTES.
OUR PRESENCE IN THE VIRTUAL ROOM
FOR ALL SEGMENTS OF THE MEETING
IS A MUST AND REQUIRED.
IT SHOULD BE NOTED THAT WHEN WE
DO THE CONCEPTS LATER TODAY,
WHILE BOTH BOARDS CAN
PARTICIPATE, ONLY BSA MEMBERS
WILL BE COUNTED IN THE VOTE.
THE QUORUM WILL BE 15 MEMBERS
FOR THE BSA.
ADDITIONALLY, FOLLOWING THE
SUBCOMMITTEE REPORTS, ONLY NCATS
MEMBERS WILL BE COUNTED IN THE
VOTE.
ALL BOARD MEMBERS CAN
PARTICIPATE IN DISCUSSION.
AND THE QUORUM WILL BE 10.
DO WE HAVE QUORUM?
>> YES WE DO.
>> SO NEXT WE NEED TO APPROVE
THE SEPTEMBER 6, 2023 NCATS
VIRTUAL MEETING SUMMARY MINUTES.
SO, WE NEED TO VOTE TO ACCEPT
THOSE MINUTES.
SO IS THERE A MOTION?
>> SO MOVED.
>> SECOND?
>> SECOND.
>> ANY FURTHER DISCUSSION?
IF NOT, WE CAN VOTE.
I'LL ASK IF THERE ARE ANY
NEIGHS, ANY ABSTENTIONS?
-- ANY NAYs -- IF NOT T SEEMS
WE HAVE UNANIMOUS VOTE.
>> GREAT, YES.
>> SO TO BE SURE THERE ARE NO
INTERRUPTIONS, PLEASE ENSURE YOU
MUTE YOUR MICS UNTIL RECOGNIZED
BY EITHER ME OR PAULET OR THE
ACTING NCI DIRECTOR OR THE
SPEAKER WHO MAY BE ANSWERING
YOUR QUESTIONS.
SO WE'LL NOW BEGIN TODAY'S,A
AGENDA WITH THE DIRECTOR'S
REPORT BROUGHT TO US BY DR. LOWY
WHO IS SERVING AS ACTING AT NCI
DIRECTOR.
DOUG.
>> GOOD MORNING KEITH AND
EVERYONE ELSE.
GOOD MORNING TO THOSE OF YOU ON
MOUNTAIN AND PACIFIC TIME AND
GOOD AFTERNOON TO THE OTHERS WHO
ARE CENTRAL AND EAST.
IT'S ONCE AGAIN MY HONOR TO BE
ACTING NCI DIRECTOR AS MANY
OTHERS KNOW, IT'S A TERRIFIC
POSITION IF I COULD HAVE THE
NEXT SLIDE.
I'M GOING TO TRY TO GET THROUGH
MY PRESENTATION IN 30 MINUTES OR
SO, SO WE HAVE AT LEAST 10
MINUTES FOR DISCUSSION
AFTERWARDS.
AND I'M DIVIDING THE
PRESENTATION INTO FOUR PARTS.
FIRST RECENT NEWS AND UPDATES.
SECOND, SOME RESEARCH AND
PROGRAMMATIC HIGHLIGHTS.
THIRD, THE NCI BUDGET OUTLOOK
AND FOURTHS, THE TIME FOR
DISCUSSION.
SO LET'S GO TO THE RECENT NEWS
AND UPDATES.
GO TWO SLIDES AHEAD, PLEASE.
THIS, AS I HOPE YOU CAN SEE, IS
WE ARE GOING TO HAVE THE THIRD
TRANSITION SINCE 2017 WITH A NEW
NCI DIRECTOR.
AND DR. RATH MEL IS GOING TO
BECOME THE NEXT NCI DIRECTOR IN
THE NEAR FUTURE.
VIRTUALLY ALL OF YOU KNOW HER.
NOT JUST BECAUSE OF HER
LEADERSHIP POSITION AT
VANDERBILT, BUT ALSO SHE HAS
BEEN ON THE BSA AND IMPORTANT
COP CONTRIBUTING MEMBER OF THE
BSA SINCE SHE JOINED IT.
MONICA, I WON'T SEA SHE IS ON TO
A BETTER PLACE, BUT SHE HAS
MOVED ACROSS THE PARKING LOT TO
BUILDING 1 AS THE NIH DIRECTOR.
SHE WAS SWORN IN A COUPLE OF
WEEKS AGO.
AND IT REALLY IS GOING TO BE A
VERY UNUSUAL OPPORTUNITY FOR NCI
TO HAVE THE CURRENT NIH DIRECTOR
TO HAVE JUST BEEN THE NCI
DIRECTOR.
IF I COULD HAVE THE NEXT SLIDE.
THIS IS SOME BAD NEWS.
ALMOST ALL OF YOU KNOW --
UNFORTUNATELY, WORTA DIED TWO
WEEKS AGO.
SHE WAS THE DIRECTOR OF THE
COMMUNITY ONCOLOGY RESEARCH
PROGRAM, WHICH REALLY IS A
LANDMARK VISIONARY PROGRAM THAT
HAS BEEN A GEM FOR NC DEVELOPMER
COMMUNITY ONCOLOGY AND THIS
HAPPENED.
WE ARE GOING TO BE HAVING
FUNDING ANNOUNCEMENTS FOR THIS
CAREER DEVELOPMENT AWARD IN THE
NEAR.
MANY OF YOU HAVE SEEN THIS
SLIDE, BUT THE CANCER MOONSHOT,
PARTICULARLY THE REIGNITED
VERSION, IS A GUIDING LIGHT FOR
US BECAUSE OF THE THREE
PRINCIPLE GOALS.
REDUCING THE DEATH RATE BY AT
LEAST 50% IN THE NEXT 25
YEARS -- AND I PUT IN
PARENTHESES, THIS IS HARD TO DO.
OVERCOMING CANCER DISPARITIES IS
EVEN HARDER.
AND THEN ENDING CANCER AS WE
KNOW IT FOR ALL IS ACTUALLY THE
HARDEST.
AND WE'RE MAKING PROGRESS IN
EACH OF THESE AREAS.
AND MONICA TALKED TO ME ABOUT
THE REIGNITED CANCER MOONSHOT
WITH FUNDS FROM THE INITIAL
MOONSHOT.
AND THEN, TO ENSURE --EUR JOB IS
TO ENSURE THAT THE AS
OPERATIONAL GOALS OF THE
REIGNITED MOONSHOT BECOME
FEASIBLE.
NEXT SLIDE.
IN SHOWS YOU ONE OF THE
ACTIVITIES, THE BIDEN
ADMINISTRATION CREATED THE
CANCER CABINET TO ADVANCE THE
GOALS OF THE CANCER MOONSHOT AND
THE MOST RECENT MEETING OF THE
CANCER CABINET WAS IN SEPTEMBER.
YOU CAN BARELY SEE PRESIDENT
BIDEN AND THE FIRST LADY ON THE
FAR SIDE.
DR. BIDEN IS IN THE RED DRESS
AND PRESIDENT BIDE EP IS NEXT TO
HER.
I WAS PRIVILEGED TO BE THERE AS
THE LOWEST-RANKING MEMBER AT THE
TABLE.
AND THEY TALKED ABOUT A LOT OF
NEW INITIATIVES.
AND THE BIOMEDICAL DATA FABRIC
DUEL BOX FOR CANCER IS ONE OF
THE ACTIVITY WE ARE DOING WITH
ARPA-H THAT WAS ANNOUNCED.
THE VETERANS FOR TOBACCO
CESSATION PROGRAMS JOINTLY WITH
THE V.A. AND NCI.
TWO-WAY DATA EXCHAINS BETWEEN
THE NCI SEAR PROGRAM AND THE
V.A. CANCER REGISTRY TO LEARN
MORE ABOUT THE IMPACT OF CANCER
ON VETERANS.
AND YOU CAN SEE THAT THE PRESS
RELEASE AT THE WEBSITE.
THE NEXT SLIDE IS WHAT MADE IT
SO EASY FOR ME TO BE HERE
BECAUSE ABOUT TWO-THIRDS OF THE
CABINET MEMBERS AGENCY HEADS
ET CETERA, WHO WERE TALKING AT
THE CANCER CABINET, WERE
DISCUSSING COLLABORATIONS THAT
THEY HAVE WITH NCI.
SO IN TERMS OF THE DEPARTMENTS,
THE DEPARTMENT OF DEFENSE AND
ENERGY AND COMMERCE AND WITHIN
THE DHHS, FDA, CDC, HRSA AND
ARPA-H AND OF COURSE MANY OTHER
COMPONENTS WITHIN HHS AND NIH.
NEXT SLIDE.
AND I ALSO REPRESENTED THE NCI
DOWN IN THE FORT LAUDERDALE AREA
FOR THOSE OF YOU WHO DON'T KNOW
WHERE IT IS, IT IS LIKE A SUBURB
OF FORT LATER DADE IN DAVEY.
AND CONGRESSWOMAN, DEBI
WASSERMAN SCHULTZ, A BREAST
CANCER SURVIVOR, ORGANIZED THIS
CANCER SURVIVORSHIP SUMMIT AND
THE KEYNOTE SPEECH WAS GIVEN BY
DR. JOE BIDEN.
AND I TALKED ABOUT SURVIVORSHIP
AND ITS IMPORTANCE AT THE
MEETING.
AND THREE OF THE FLORIDA CANCER
CENTERS, NCI-DESIGNATED CANCER
CENTERS, THE HEADS, WERE THERE
AS WELL AND HAD A VERY
INTERESTING PANEL DISCUSSION
AMONG THEM.
NEXT SLIDE.
SO I WANT TO GO ON AND TALK
ABOUT RESEARCH AND PROGRAMMATIC
HIGHLIGHTS.
THIS IS NOT EVERYTHING WE ARE
DOING.
IT'S NOT NECESSARILY EVEN THE
MOST IMPORTANT THINGS.
BUT I THINK THAT THEY LARGELY
RELATE TO DIFFERENT ASPECTS OF
THE MOONSHOT EITHER DIRECTLY OR
INDIRECTLY.
NEXT SLIDE.
THIS IS A VERY RECENT PAPER
ABOUT THE NUMBER OF
CANCER-SPECIFIC DEATHS THAT
COULD BE AVERTED PER 100,000
ELIGIBLE FOR SCREENING.
WHAT THE NUMBERS SHOW IS PER
100,000, THE NUMBER OF DEATHS
THAT COULD BE AVERTED IF THERE
WERE A 10% INCREASE IN THE
SCREENING FOR LUNG CANCER,
COLORECTAL, BREAST AND CERVICAL
CANCER.
YOU CAN SEE THAT LUNG CANCER HAS
A LOT.
IF YOU ADDED SMOKING CESSATION,
LET'S SAY YOU HAD A 15% SUCCESS
RATE, IT COULD INCREASE THE
NUMBER OF DEATHS PREVENTED FROM
LUNG CANCER.
WHAT'S NOT SHOWN ON THIS SLIDE
IS THAT THERE ALSO WOULD BE MANY
DEATHS PREVENTED IF THERE WAS
SMOKING CESSATION FROM A
DECREASE IN CARDIOVASCULAR AND
PULMONARY DISEASE.
COLORECTAL CANCER IS ALSO HIGH.
BREAST CANCER AND CERVICAL
CANCER CERTAINLY WOULD PREVENT
SOME BUT NOT AS MANY AS LUNG
CANCERS AND COLORECTAL CANCER
SCREENING.
AND I WANT TO ALSO EMPHASIZE
THAT LUNG CANCER SCREENING
ACTUALLY IS FOR UNDER
REPRESENTED MINORITIES AND FOR
WOMEN THAT THEY ARE -- THEY TEND
TO BE UNDERREPRESENTED WITH
CURRENT LUNG CANCER SCREENING
GUIDELINES.
SO THIS -- IF THERE WAS AN
INCREASE IN SCREENING OF
ELIGIBLE PEOPLE, IT COULD HELP
TO NARROW DISPARITIES.
NEXT SLIDE.
AND THE PAPER THAT I WAS JUST
SHOWING WAS REALLY THE SENIOR
AUTHOR IS ROCKY FEUER, WHO IS
GOING TO BE RETIRING NEXT MONTH.
AND ROCKY REALLY IMVENTED SIS
NET, AND THOSE WHO HAVE BEEN ON
THE BSA ESPECIALLY, REMEMBER THE
RE-ISSUANCE OF CISNET.
BUT IT IS A MODELING NETWORK
THAT HAS HAD ENORMOUS IMPACT,
NOT JUST AT THE LEVEL OF NCI AND
CANCER RESEARCH, BUT WITH THE
PREVENTION SERVICES TASK FORCE
FOR THEIR RECOMMENDATIONS.
HE ALSO DEVELOPED THE JOINT
POINT AND NOW SOFTWARE IS
AVAILABLE FOR MEASURING THAT,
WHICH IS THE STANDARD WAY OF
MEASURING CANCER TRENDS IN SEER
AND INCIDENTS-BASED MORTALITY.
FOR EXAMPLE, THIS IS LOOKING
BACK AT WHAT WAS THE PRIMARY
CANCER AND THEN THE METASTASES.
IN THE PAPER THAT ROCKY WAS
INVOLVED WITH BACK IN 2020,
LOOKING AT ADVANCES IN LUNG
CANCER TREATMENT, A SUBSET OF
THOSE PEOPLE WHO WERE PUT DOWN
AS HAVING DIED FROM LUNG CANCER,
THEIR PRIMARY CANCER WAS
ELSEWHERE AND THEY WERE DYING
FROM METASTATIC CANCER TO THE
LUNG BUT IT WAS NOT PRIMARY LUNG
CANCER.
AND THIS WAS USING THIS ASSAY OF
INCIDENCE-BASED MORTALITY AND
DR. FEUER AS BEEN NOMINATED FOR
A SAMMIES AWARD.
HE HAD AN ENORMOUS IMPACT AND
WE'LL BE -- WILL BE MISSED.
SOCIAL DETERMINANTS OF HEALTH.
VERY IMPORTANT FOR MANY
DIFFERENT ASPECTS BUT THIS
PAPER, ONE OF THE THINGS IT
EMPHASIZED IS CANCER SCREENING
INTERVENTIONS.
AND BASICALLY SOCIAL
DETERMINANTS OF HEALTH WHETHER
YOU'RE ON A LOWER END OR UPPER
END, ACTUALLY HAS A SUBSTANTIAL
ASSOCIATION WITH WHETHER YOU'RE
GOING TO BE SCREENED OR NOT.
THIS IS NOT SURPRISING BUT THIS
IS EVIDENCE THAT THE IMPORTANCE
OF SOCIAL DETERMINANTS OF HEALTH
IS CRITICAL PARAMETER.
NEXT SLIDE.
ONE OF THE THINGS THAT WE'RE
TRYING TO DO IS TO THE EXTENT
POSSIBLE, BRING CANCER CARE,
CANCER SCREENING AND CANCER
PREVENTION TO THE PATIENT RATHER
THAN BRINGING THE CANCER CONTROL
AND TREATMENT OF THE PATIENT TO
THOSE INTERVENTIONS.
SO, CERVICAL CANCER IS AN
INTERESTING SITUATION BECAUSE
EVERYTHING THAT'S FDA APPROVED
IS APPROVED WITH HEALTH CARE
WORKERS DOING THE SAMPLING.
BUT MANY COUNTRIES ACTUALLY HAVE
SELF SAMPLING AND IT'S A WAY OF
BRINGING SCREENING TO THE
PATIENT INSTEAD OF BRINGING THE
PATIENT TO THE SCREENING, AT
LEAST INITIALLY.
AND WE KNOW THAT ABOUT HALF OF
THE PATIENTS WHO ARE
UNDERSCREENED, THAT'S WHERE HALF
OF THE PEOPLE WHO GET CERVICAL
CANCER IN THE U.S. COME FROM.
AND WE ALSO KNOW THAT THE
UNDERSCREENED PATIENTS ARE
UNDER-INSURED.
AND MANY OF THEM ARE HISPANIC.
THIS COULD BE YET AUTHOR WAY OF
TRYING TO HELP ADDRESS
PARTIALLY, OVERCOME A HEALTH
DISPARITY.
WE ARE WORKING WITH THE FDA
COMPANIES TO DO THIS LAST MILE
INITIATIVE OF RANDOMIZED CONTROL
TRIAL TO TRY TO PROVIDE
SUFFICIENT EVIDENCE FOR THE FDA
TO WORK THROUGH SELF SAMPLING.
NEXT SLIDE.
AND YOU HAVE ALL HEARD, BECAUSE
YOU WERE INVOLVED IN THE INITIAL
PRESENTATIONS OF THE VANGUARD
STUDY FOR THE MULTI-CANCER
DETECTION TEST.
AND WE'RE LOOKING FORWARD AT THE
BEGINNING OF THE YEAR TO BE ABLE
TO FUND MULTIPLE CANCERS THAT
WILL BE STARTING, THE INITIAL
SCREENING STUDY THAT IS REFERRED
TO AS THE VANGUARD STUDY.
NEXT SLIDE.
SO THIS SLIDE REALLY IS GOING
FROM THE SCREENING ISSUE TO
LOOKING AT MORTALITY RATES.
AND IT'S FROM A PAPER THAT WAS
PUBLISHED LAST YEAR, PRIMARILY
FROM INVESTIGATORS IN DCCPS AND
BOB COIL WAS THE LAST AUTHOR OF
THE PAPER.
IT'S REALLY DIVIDED, IF YOU
WILL, INTO THREE PARTS.
CANCER MORTALITY RATES AND ALL
SITES, LUNG AND BRONCH US IN THE
MIDDLE AND COLORECTAL ON THE
RIGHT.
AND THE WADE -- AND THE WHITE
BARS ARE NON-POSTIE COUNTS, AND
THE BLACK BARS ARE THE
PERSISTENT POVERTY COUNTERRIES.
WHAT I THINK YOU CAN SEE IF YOU
LOOK AT ALL SITES, IS THAT THERE
IS A HIGHER MORTALITY RATE FOR
BLACKS COMPARED TO WHITES.
THERE DOESN'T SEEM TO BE A MAJOR
DIFFERENT FOR THE URBAN PEOPLE
WHETHER THEY ARE UNTIL POOR
COUNTIES OR NOT.
BUT WHEN YOU LOOK AT THE RURAL
COUNTIES UTHAT'S WITH THE RED
OVAL, THEIR MORTALITY RATES ARE
A BIT HIGHER BOTH FOR BLACKS AND
WHITES COMPARED TO THE
COMPARABLE URBAN POPULATION.
BUT IF YOU NOW TURN TO LUNG AND
BRONCHUS IN THE MIDDLE, WHAT I
HOPE YOU CAN APPRECIATE IS THAT
THE RURAL MORTALITY RATES FOR
BOTH BLACK PATIENTS AND WHITE
PATIENTS ARE SUBSTANTIALLY
HIGHER THAN THE MORTALITY RATES
FOR BLACK AND WHITE PATIENTS WHO
ARE URBAN PATIENTS.
AND THIS IS PROBABLY A
COMBINATION OF MORE SMOKING IN
RURAL AREAS AND PROBABLY IN
ADDITION, LESS ACCESS TO THE
ADVANCES IN CANCER -- LUNG
CANCER TREATMENT.
AND THE DIFFERENCE THAT YOU SEE,
ESPECIALLY IN THE RURAL
POPULATIONS WITH THE PERSISTENT
POVERTY VERSUS THE NON-POVERTY
GROUPS, ARE SUBSTANTIAL WITH
LUNG AND BRONCHUS AND YOU CAN
SEE THAT IF YOU LOOK OVER AT
COLORECTAL, AGAIN IN THE RURAL
AREA, PERSISTENT POVERTY IS VERY
IMPORTANT BOTH FOR BLACK RURAL
PATIENTS AND WHITE RURAL
PATIENTS.
NEXT SLIDE.
SO THIS SLIDE SHOWS YOU WHAT HAS
HAPPENED OVER THE LAST COUPLE OF
DECADES WITH REGARD TO INCIDENCE
OF LUNG CANCER AND MORTALITY
RATES FOR LUNG CANCER.
IF YOU LOOK FIRST AT THE TOP
TABLE OR THE TOP PART OF THE
GRAPH, YOU CAN SEE THAT THERE IS
A PROGRESSIVE DECREASE IN THE
INCIDENCE OF LUNG CANCER.
THIS IS PREDOMINANTLY BECAUSE OF
SMOKING CESSATION.
IF YOU LOOK AT THE TABLES,
YOU'LL SEE THAT THE RATE OF DOE
CREASE IS ABOUT 2% PER YEAR IN
INCIDENTS.
BUT IF YOU NOW TURP TO YOUR
ATTENTION TO THE MORTALITY
RATES, WHAT I HOPE YOU CAN
APPRECIATE, ESPECIALLY IN THE
TABLE, IF YOU LOOK ALL THE WAY
ON THE RIGHT, THE ANNUAL
PERCENTAGE CHANGED IN EACH OF
THE LAST SIX YEARS IS OVER 4
1/2%, 4.7% ANNUAL CHANGE.
SO IT'S MORE THAN TWICE THE
MORTALITY RATES ARE GOING DOWN
BY MORE THAN TWICE AS FAST FOR
LUNG CANCER AS FOR THE INCIDENCE
RATES.
AND THIS, WE THINK, IS LARGELY
ATTRIBUTABLE TO ADVANCES IN
CANCER TREATMENT.
SHOWING THE NEXT SLIDE, IT SHOWS
THIS ADVANCE IS LARGELY WHAT
HAPPENED WITH LUNG
ADENOCARCINOMA.
YOU CAN SEE ALL OF THESE
DIFFERENT DRUG APPROVALS JUST IN
THE LAST TWO YEARS FOR LUNG
CANCER.
AND I JUST WANT TO LARK EN BACK
TO WHAT YOU SAW -- HARKEN
BACK -- WITH THE RURAL VERSUS
URBAN PATIENTS.
WE SUSPECT IN TRYING TO DO
NANCYS TO PROVIDE EVIDENCE THAT
THE PEOPLE IN RURAL AREAS JUST
DON'T HAVE AS MUCH ACCESS TO
THESE NEW DRUGS THE WAY THAT
PEOPLE IN URBAN AREAS HAVE.
NEXT SLIDE.
AND FOR THOSE ON THE NCAB,
CARLENE RILEY IN SEPTEMBER, DID
A REALLY TERRIFIC PRESENTATION
ABOUT MY PART, WHICH IS THE
ACRONYM FOR HIGH TIDE AT RICK
AND ADULT RARE TUMOR NETWORK.
THIS IS A MOONSHOT ACTIVITY FROM
MOONSHOT 1.0.
IS IT FOCUSED ON THE CLINICAL
CENTER BUT IT IS NOT JUST AN
EXTRAMURAL-INTRAMURAL
COLLABORATION BUT IT IS ALSO AN
INTERNATIONAL COLLABORATION.
MORE THAN 25 DIFFERENT COUNTRIES
HAVE CONTRIBUTED PATIENTS.
THEY ENROLLED MORE THAN 500
PATIENTS IN THE LAST FOUR YEARS.
AND FOR THOSE OF OFF WHO ARE NOT
ON THE NCAB, I REALLY URGE YOU
TO GO TO THE NCAB WEBSITE AND
LOOK AT THE SLIDES THAT DR. WEED
MAP AND DR. RILEY PRESENTED
BECAUSE IT'S A VERY EXCITING AND
IMPORTANT AREA.
AND FOR THOSE OF YOU WHO DON'T
KNOW WHILE RARE CANCERS ARE BY
DEFINITION, RARE, THEY REPRESENT
ABOUT 27% OF THE CANCER IN THE
UNITED STATES.
SO, IT'S MORE THAN A HALF
MILLION CANCERS PER YEAR IN THE
UNITED STATES ARE RARE TUMORS.
AND THEY REPRESENT ABOUT 25% OF
THE CANCER DEATHS.
SO THAT THE RARE CANCERS ACCOUNT
FOR ABOUT 150,000 PEOPLE DYING
EACH YEAR IN THE UNITED STATES.
SO THIS INITIATIVE REALLY IS
HOPING TO BE ABLE TO CATALOG
THESE PATIENTS BETTER AND ALSO
IN ITS NEW FORM TO BE ABLE TO
DEVELOP INTERVENTIONS WHERE IT
LOOKS LIKE THERE ARE CANDIDATES
THAT COULD BE USEFUL FOR NEW
INTERVENTIONS.
NEXT SLIDE.
AND THIS IS ANOTHER IMPORTANT
ADVANCE ON THE TREATMENT SIDE.
THE PD-L1 IMMUNE CHECKPOINT
INHIBITOR.
THIS WAS LED BY THE INTRAPURELY
PROGRAM, ABOUT 40% OF THE
PATIENTS WERE TREATED
INTRAMURALLY BUT THIS REALLY IS
THE FIRST TIME THAT IS THIS A
RARE CANCER THAT EFFECTS MOSTLY
ADOLESCENCE AND YOUNG ADULTS AND
IT'S THE FIRST TIME THAT THIS
IMMUNE CHECKPOINT INHIBITOR HAS
BEEN APPROVED FOR CHILDREN IN
THE NEW ENGLAND JOURNAL OF
MEDICINE ARTICLE A COUPLE OF
MONTHS AGO REPORTING THIS
ADVANCE.
NEXT SLIDE.
NOW THE BUDGET OUTLOOK.
I JUST, BEFORE WE GET STARTED, I
WANT YOU TO KNOW I HAVE DONE MY
PART BECAUSE I WAS ABLE TO FIND
MY BUSINESS CARDS FROM THE LAST
TIME THAT I WAS ACTIVE DIRECTOR.
AND USING THEM, IT TURNS OUT
THAT ALTHOUGH I HAVE SAVED THE
NCI A LOT OF MONEY, IT'S NOT
ENOUGH.
SO LET ME TELL YOU ABOUT THE
BUDGET SITUATION.
NEXT SLIDE.
AT FIRST LET'S LOOK AT THE TOP
PART.
WE'VE HAD A BIG INCREASE.
IF YOU LOOK AT FY17, COMPARED TO
FY23, WE WENT FROM ABOUT 5.5
BILLION DOLLARS TO OVER 7
MILLION DOLLARS FOR THE TOTAL
APPROPRIATION.
THE MOONSHOT FUNDS REPRESENTED
AN IMPORTANT COMPONENT OF THOSE
APPROPRIATIONS.
300 MILLION IN' 17 AND 216 IN
23.
IN 24, WE DON'T KNOW WHAT IS
GOING TO HAPPEN.
NOW JUST FOCUS ON THE BOTTOM
PART WHERE IT HAS TO DO WITH THE
PAY LINES BETWEEN 2017 AND 2023.
THE TOP PART OF THAT TABLE SHOWS
THE EXPERIENCED INVESTIGATORS,
THEIR PAY LINE.
AND IT HAS BEEN VERY LOW.
WE HAVE BEEN TRYING TO INCREASE
THE PAY LINE EACH YEAR AND HAVE
SUCCEEDED TO SOME DEGROW BUT WE
HAD TO GO DOWN, FOR EXAMPLE, IN
2019, TO THE 8th PERCENTILE,
WHICH IS JUST -- GOING DOWN INTO
SINGLE-DIGITS IS TERRIBLE AND
THAT'S WHERE WE ARE FOR THE
CONTINUED RESOLUTION, AS I'M
SURE YOU KNOW AND I'LL SHOW YOU
IN SUBSEQUENT SLIDE.
STARTING IN FY18, WE ALSO GAVE A
BOOST TO THE EARLY-STAGE
INVESTIGATORS FOR THEIR RO1 OP
INDICATION OF 5 POINTS.
AND I JUST WANT TO POINT OUT
THAT IN 200019, WHEN WE WENT
DOWN TO THE 8th PERCENTILE,
WE KEPT THE BOOST AT 14.
IT WAS A 6 PERCENTILE
DIFFERENCE.
AND TRY AS WE MIGHT, WE
INCREASED THE PERCENTAGE OF THE
NCI BUDGET OVER THE LAST FOUR
YEARS FROM 41% IN THE RPG POOL
TO 44%.
BUT IT UNIVERSITY DOESN'T KEEP
PACE WITH EVERYTHING THAT
WE'RE -- IT DOESN'T KEEP PACE --
NEXT SLIDE.
AND EVERYTHING IS INTERCONNECTED
WITH THE NCI BUDGET.
IF YOU LOOK ON THE TOP RIGHT,
THE ULTIMATE GOAL IS IMPROVED
HEALTH OUTCOMES.
BUT GOING AROUND THE GEARS, WE
NEED TO HAVE THE RESEARCH
FUNDING, TRAINING AND WORKFORCE
DEVELOPMENT, RESOURCES FOR
RESEARCHERS, OPERATING EXPENSES,
CLINICAL CENTERS AND CLINICAL
TRIALS.
JUST TO HIGHLIGHT A FEW OF THE
IMPORTANT COMPONENTS.
THE NEXT SLIDE TELLS YOU THAT
THE NCI BUDGET IS NOT DEVELOPED
IN A VACUUM.
AND IT'S NOT JUST DEVELOPED
WITHIN THE CONTEXT OF NIH.
BUT IT'S REALLY DETERMINED
WITHIN THE FEDERAL BUDGET
ECOSYSTEM ALONG WITH MANY OTHER
NATIONAL PRIORITIES AS DEFINED
BY CONGRESS.
AND SO THAT NEEDS TO -- FOR
FY24, ALTHOUGH WE ARE -- TODAY
IS THE LAST DAY OF THE SECOND
MONTH OF FY24.
NEXT SLIDE.
WHERE ARE WE?
THE POTENTIAL LAPSES IN
APPROPRIATION AVERTED WERE
SEPTEMBER 30 AND NOVEMBER 17.
THAT'S WHEN WE HAD CONTINUING
RESOLUTIONS.
THE FIRST ONE WAS SIGNED
SEPTEMBER 30.
THE LAST ONE WAS TWO WEEKS AGO.
AND THAT CURRENT CONTINUING
RESOLUTION EXPIRES ON FEBRUARY
2, WHICH NOT ONLY IS GROUNDHOG
DAY AND WE ARE HOPING IT WON'T
REPRESENT THE FILM WITH BILL
MURRAY WITH THE SAME THING
HAPPENING AGAIN AND AGAIN, BUT
1/3 OF THE FISCAL YEAR WILL HAVE
PASSED AT THAT POINT.
AND NK HOLOHAN, WAS GOING TO BE
TALKING ABOUT MORE ABOUT THE
KNOWLEDGEET.
INTERIM PAY LINES HAVE BEEN SET.
THEY WON'T BE SET UNTIL THE NCI
RECEIVES A FULL YEAR
APPROPRIATION.
SO THIS IS THE SAD POSITION THAT
WE FIND OURSELVES WITH THE
FUNDING THAT WE CURRENTLY HAVE
FOR THE CONTINUING RESOLUTION.
IT'S VERY SIMILAR NIH-WIDE WITH
9th PERCENTILE WITH
ESTABLISHED INVESTIGATORS.
AND 14th FOR EARLY STAGE
INVESTIGATION AND R21 ALSO
9th.
NONCOMPETING GRANTS BEING FUNDED
AT 90%.
THIS WAS RECOMMENDED BY NIH.
NEXT SLIDE.
SO THE BUDGET OUTLOOK FOR THE
NEXT TWO YEARS.
WE PUT OUT THE PROFESSIONAL
JUDGMENT BUDGET, DIANE AND HER
COLLEAGUES HAVE LED THAT EFFORT.
AND THE PROFESSIONAL JUDGMENT
BUDGET FOR FY24 WHICH WE PUT OUT
LAST YEAR, WAS ESSENTIALLY FOR
10 BILLION DOLLARS.
THE PRESIDENT'S BUDGET PROPOSAL
FOR NCI FOR FY24 WAS 7.8.
IT REPRESENTED ABOUT A 700
MILLION DOLLARS INCREASE OVER
FY23 FOR THE BASE BUDGET BUT IT
WAS REALLY 500 MILLION ABOVE
FY23 AND CONTINUING THE 216
MILLION WE GOT IN FY23 FOR THE
CANCER MOONSHOT.
AND BACK IN SEPTEMBER WHEN WE
PUT OUT THE BUDGET PROPOSAL FOR
FY25, WE PROPOSED CLOSE TO 11.5
BILLION DOLLARS.
AND JUST FOR YOU TO SEE THE
EXCLA POLICE STATION PINTS AT
THE BOTTOM, JUST TO MAINTAIN THE
FY23 PAY LINE -- EXCLAMATION
POINTS -- AND TO FUND THE
CONTINUING GRANTS, THE
NONCOMPETING GRANTS, WE WOULD
NEED TO ADD 250 MILLION DOLLARS
JUST IN FQ24 TO THE RPG POOL.
AND WE IN ADDITION, INCURRED
BETWEEN 75 AND 100 MILLION
DOLLARS EACH YEAR INCREASE
MANDATORY EXPENSES, PHYSICAL
SECURITIESY, CYBERSECURITY,
UTILITIES, CENTERS FOR
SCIENTIFIC REVIEW ET CETERA.
PLANE OF THEM.
NEXT SLIDE.
-- MANY OF THEM.
THIS IS A SLIDE THAT SOME OF YOU
HAVE SEEN BEFORE, WE TALKED BACK
IN JUNE AND WHAT I WANT TO
EMPHASIZE HERE IS THE 10-YEAR
INTERVAL BETWEEN 2003 AND 2014.
AND THE 10-YEAR INTERVAL BETWEEN
2013 AND 2023.
THERE WERE VERY FEW INCREASES IN
THE NIH BUDGET BETWEEN 2003, THE
END OF THE DOUBLING AND 2000
THIRTEEN.
AND OUR PURCHASING POWER WENT
DOWN BY ESSENTIALLY A QUARTER,
24% LESS.
FAST FORWARD TO 2013-2023, AND
WE HAVE GOTTEN INCREASES EACH OF
THE YEARS BETWEEN 2015 AND 2023.
SO NINE OF THOSE 10 YEARS.
WE ARE STILL 13% UNDER WHERE WE
WERE IN 2003.
SO THE DEFICIT AFTER NINE
CONSECUTIVE YEARS OF INCREASED
FUNDING, WAS SIMPLY CUT IN HALF.
AND WHAT DOES THAT REPRESENT IN
TERMS OF PURCHASING POWER OR
BUYING POWER IN FY23 FUNDS?
1.1 BILLION DOLLARS LESS THAN 20
YEARS AGO.
SO THIS IS -- THIS IS PART OF
THE REASON THAT WE'RE TRYING TO
REALLY DO MORE WITH LESS.
AND THE OPPORTUNITIES ARE JUST
EXTRAORDINARY.
NEXT SLIDE.
AND THIS SLIDE SHOWS YOU THAT A
FLAT BUDGET IS NOT TRULY FLAT,
AS WELT IN AND I SAID BACK IN
JUNE.
-- WEST IN: RESEARCH COST
CONTINUED TO INCREASE.
THE CURIOUS FUNDING OVER THE
LAST YEAR WAS FY23 AND AUTO NON
NEGOTIABLE.
AND THEY REQUIRE NCI CUTS ACROSS
VARIOUS PROGRAMS AND THIS GIVES
YOU THE VARIOUS EXAMPLES WHERE
YOU CAN HAVE THESE CONSULT.
NEXT SLIDE.
-- CUTS.
AND THIS IS JUST SORT OF A
SUMMARY SLIDE.
WE HAVE WRITTEN QUITE A ABOUT
ABOUT THE BUDGET AND THE THIS
GIVES YOU THE LINKS TO THESE
VARIOUS KINDS OF ASPECTS AND MK
HOLOHAN WILL BE DISCUSSING IT.
SO I THINK THAT'S MY LAST SLIDE.
CAN WE GO TO THE LAST ONE?
I WANT TO THANK YOU FOR YOUR
ATTENTION.
I'M LOOKING FORWARD TO YOUR
QUESTIONS AND COMMENTS.
I'M HAPPY TO ANSWER ANY EASY
QUESTIONS ABOUT THE BUDGET.
IF YOU ASK ME ANY DIFFICULT
ONES, I'LL TELL YOU THAT MK IS
GOING TO COVER THEM.
>> THAT'S GREAT, THANK YOU VERY
MUCH FOR THAT FANTASTIC
OVERVIEW.
AND SO WE CAN NOW OPEN UP THE
FLOOR FOR QUESTIONS.
I SEE KARIN'S HAND.
KARIN?
>> KARIN: THANK YOU FOR THE
LEADERSHIP AND OTHER FOR THE
INCREDIBLE UPDATE.
VERY MUCH APPRECIATED.
I WAS STRUCK BY THE BEAUTIFUL
GRAPHIC FROM THE DATA THAT YOU
REPORTED LOOKING AT THE
POTENTIAL IMPACT OF WHAT IT
WOULD MEAN FOR CAPSER PATIENTS
AND OUTCOMES IF MORE SCREENING
COULD BE HAD.
ONE OF THE ONES YOU FOCUSED ON
WAS LUNG CANCER.
AND AFTER A MULTI-YEAR STUDY WE
RELEASED NEW AT THE AMERICAN
CANCER SOCIETY, A LUNG CANCER
SCREENING GUIDELINES WHICH
SIGNIFICANTLY EXPANDED
ELIGIBILITY FOR LUNG CANCER
SCREENING.
NOW WE'LL SEE WHAT HAPPENS.
TRADITIONALLY U.S. PREVENTION
TASK SEVERANCES FOLLOWS US.
BUT I THINK THESE KINDS OF DATA
CAN BE USED TO CHANGE HEARTS AND
MINDS AND SERVE AS A CALL TO
ACTION FOR PEOPLE TO GET INTO
SCREENING.
I'D LOVE FOR US HO TO THINK
ABOUT HOW TO TAP INTO RESOURCES
SO WHEN THERE IS A NEW GUIDELINE
DROPPED, WE COULD HAVE AN
OPPORTUNITY TO DO THOSE MODELS
AND SAY ACCORDING TO THESE
GUIDELINES, THIS NUMBER OF
PEOPLE MAY BENEFIT AND THIS
COULD BE THE POTENTIAL OUTPUT.
JUST, A THOUGHT ABOUT HOW WE
TAKE THAT, NOT JUST WHOLE OF
GOVERNMENT BUT WHOLE OF CANCER
COMMUNITY APPROACH TO CREATE
CALLS TO ACTION FOR SCREENING.
>> KARIN, THANKS TO ACS FOR YOUR
LEADERSHIP.
AND I JUST WANT TO POINT OUT,
THAT THE ACS GUIDELINES ARE
SIMILAR TO BUT NOT IDENTICAL TO
THOSE OF THE PREVENTION SERVICES
TASK FORCE WHEN THEY EXPANDED
THE CRITERIA IN 2021.
WHAT ACS IS SAYING IS, IF YOU
ARE A FORMER SMOKER AND YOU WERE
ELIGIBLE, BECAUSE YOU HAD A
20-BACK YEAR OR MORE, YOU
CONTINUE TO BE ELIGIBLE FOREVER
WHETHER IT'S 15 YEARS OR MORE
THAN 15 YEARS SINCE YOU STOPPED.
BUT I WANT TO THE REPEAT
SOMETHING I SAID, WHICH IS THAT
THAT THIS IS A HEALTH DISPARITY.
AND TRYING TO GET MORE PEOPLE
WHO ARE ELIGIBLE TO HAVE LUNG
CANCER SCREENING, COULD BE --
IT'S NOT GOING TO TAKE CARE OF
ALL THE DISPARITIES BUT IT'S A
WAY OF TRYING TO OVERCOME THEM.
KARIN, THANKS.
>> WE ARE GOING TO GO TO CHEEK
AND THEN NEILY AND THENOTIS.
>> THANK YOU VERY MUCH FOR YOUR
LEADERSHIP.
IT WAS INTERESTING TO SEE THE
WORK AND THE PAIN THAT WE HAVE
BEEN THROUGH AND ALL OF US FEEL
WELL PAIN.
I WANTED TO ALSO CHANNEL BACK TO
THE POINT YOU MADE ABOUT THE
MOONSHOT INITIATIVES AND THE
OBJECTIVES ASPIRATIONS GOING
FROM THE HARD, HARDER TO
HARDEST.
I GUESS IT WILL BE HELPFUL OR
USEFUL TO HEAR FROM YOU AND
OTHERS IN TERMS OF WHAT IS NCI
DOING TO TURN THE HARDER TO
SOMETHING THAT IS SOLVABLE.
FOR INSTANCE, DISPARITIES ARE
HARDER TO SOLVE BUT I DON'T
THINK THEY ARE IMPOSSIBLE TO
SOLVE.
AND I DO THINK THAT SOME
COORDINATED LONG-TERM STRATEGY
COULD MAYBE CHANGE THAT THINKING
AROUND AND HELP US ADDRESS IT.
ACROSS THE TALENT POOLS, I THINK
WE HAVE ABILITY AND CAPACITY TO
DO IT.
I KNOW NCI IS DOING A LOT OF
WORK IN THIS AREA AND I'M
INTERESTED TO HEAR YOUR THOUGHTS
AROUND THAT.
>> I WOULD SAY THAT FOR EXAMPLE,
I PRESENTED A COUPLE OF THINGS
WHICH COULD BE DONE.
TO ME, TRYING TO MORE EQUITABLY
DISTRIBUTE CURRENT STANDARD OF
CARE IS A VERY IMPORTANT PART.
I THINK THAT IT'S NOT JUST A
QUESTION OF RESEARCH.
IT ALSO IS A QUESTION OF POLICY.
AND I LIKE THE IDEA OF NCI NOT
DETERMINING THE POLICY BUT BEING
AT THE TABLE TO HELP DISCUSS
POLICY AND HOW POLICY CHANGES
COULD REALLY IMPROVE THE
SITUATION, BECAUSE FROM MY
PERSPECTIVE, YOU NEED TO DO
THINGS AT SCALE IN ORDER TO
REALLY HAVE AN IMPACT.
WE COULD SPEND A LONG TIME ON
IT.
I DON'T WANT TO TAKE MORE THAN
THAT.
I APOLOGIZE.
JOHN, IS THAT OKAY?
>> ABSOLUTELY.
AND I AGREE.
THE QUESTION IS ABOUT STRATEGY,
RIGHT?
AND WHEN WE LOOK AT THE BIG
PICTURES, HOW DO WE MOST
STRATEGICALLY -- WHERE ARE THE
BIG HITS, RIGHT?
THAT CAN REALLY MOVE THAT
MORTALITY RATE DOWNWARD, RIGHT?
SO I THINK IT'S A GREAT QUESTION
AND THANKS FOR YOUR COMMENTARY.
NEILY AND THENOTIS.
>> THANK YOU AGAIN FOR DOUG FOR
STEPPING UP AND ALWAYS
THOUGHTFUL PRESENTATIONS.
I WAS STRUCK BY THE DATA THAT
YOU SHOWED ON THE HOW WE HAVE
NOT ONLY RACIAL DISPARITIES BUT
HOW WE HAVE ALSO MORALITY OR
DISTANCE AS A DISPARITY PLAYING
A MAJOR ROLE.
SO THIS WAS ONE SPECIFIC
ANALYSIS WHICH MAY GIVE US SOME
ROOM FOR INTERVENTIONS AND THINK
CAREFULLY ABOUT IT.
YOU MENTIONED THERE ARE OTHER
ANALYSIS UNDERWAY.
COULD THIS BE DONE MORE BROADLY
TO UNDERSTAND WHERE WE HAVE
POSSIBILITIES TO INTERVENE AND
THINK CAREFULLY ABOUT HOW TO
ADDRESS DISPARITIES ACROSS THE
SPECTRUM?
>> YES.
WE ARE DOING TWO DIFFERENT KINDS
OF ANALYSIS, ONE FOCUSED ON LUNG
CANCER AND THE OTHER ON CANCER
TOTALITY.
BUT IN THAT ONE, WE ARE LEADING
THAT EFFORT AND LOOKING AT
SURVIVAL RATES FOR DIFFERENT
GROUPS.
SO I THINK THAT THAT WILL BE
QUITE -- THAT WILL BE QUITE
INTERESTING.
AND WHEN I TALK WITH NEILY,
ONE-ON-ONE, SHE ALWAYS TELLS ME,
WE'RE NOT RURAL, WE'RE FRONTIER,
AS THOUGH THAT IS -- AND EVEN
MORE DISBURSED POPULATION.
>> EVEN ASPECTS RELATED TO
AMERICAN INDIANS AND
RESERVATIONS WHERE THEY ARE VERY
COMPLICATED.
OTIS?
>> THANK YOU, DOUG FOR ALL THAT
YOU HAVE DONE.
I WANT TO ASK -- YOU HAVE GIVEN
A TREMENDOUS ARGUMENT THAT LUNG
CANCER SCREENING IS VERY, VERY
EFFECTIVE.
BUT I WOULD ASK THAT IN OUR
RHETORIC WE TALK ABOUT THE
POLICY NEEDS.
I WAS CHIEF OF ONCOLOGY AT A
MAJOR CANCER HOSPITAL, GRADY,
WHERE WE HAD FOUR CT SCANNERS.
IF I HAD STARTED A LUNG CANCER
SCREENING PROGRAM, I WOULD HAVE
USED ONE OF THOSE CT SCANNERS,
MADE THE LINE FOR CT SCANNERS
EVEN LONGER AND INCREASED
DISPARITIES IN OTHER THAN LUNG
CANCER JUST BY DOING THAT
SCREENING PROGRAM, NOT TO
MENTION I'D ALSO HAVE TO SPEND
SOME MONEY TO BRING IN PEOPLE
WHO COULD DO A GOOD JOB OF
READING THE CTs AND TREATING
THE PATIENT.
AND I'M NOT SAYING THIS IS WHY
WE SHOULD NOT SCREEN FOR LUNG
CANCER.
I'M SAYING WE NEED TO TALK TO
THE POLICYMAKERS ABOUT GETTING
ADDITIONAL RESOURCES INTO THESE
HOSPITALS SO THAT THIS CAN BE
DONE.
TO JUST SAY IT WORKS AND COME UP
WITH A GUIDELINE, IS NOT GOING
TO SAVE LIVES.
THAT'S HALF THE WAY.
THANK YOU.
>> AGREED.
AND IMPROVEMENTS IN TECHNOLOGY
AS WELL.
SO THANKS.
MARK AND THEN KARIN.
>> HI, THANKS AGAIN DOUG FOR THE
TALK.
CRITICALLY IMPORTANT ISSUES.
AND THIS MAY BE A LITTLE BIT
OF -- MAYBE IT'S CRAZY
SUGGESTION BUT MAYBE NOT.
YOU MENTION THE CANCER SCREENING
NETWORK, AND THE DETECTION
ASSAYS.
WAT VE EVIDENCE-BASED SCREENING
OF LUNG CANCER WE HAVE BEEN
TALKING ABOUT.
YOU SUGGESTED THAT IT'S A POLICY
ISSUE.
WHICH IS TRUE BUT IT ALSO
SUGGESTS THE NEED -- THERE IS
NEW CANCER SCREENING RESEARCH
NETWORK.
THERE MAY NEED TO BE SOMETHING
ALONG THE LINES OF
IMPLEMENTATION SCIENCE NETWORK.
THROUGH MOONSHOT WE DID SOME OF
THIS WITH COLORECTAL CANCER
SCREEN ACROSS SITES BUT IT
WASN'T THE SAME METHODOLOGY.
BUT A NATIONAL COORDINATED
RESEARCH NETWORK AROUND GETTING
SOME OF THESE THINGS INTO
HEIGHTENED AREAS LIKE REMOTE
RURAL AREAS.
THERE COULD BE NARRATIVE IN
THAT.
SO SOMETHING TO THINK ABOUT FOR
THE FUTURE.
>> ABSOLUTELY.
THANK YOU VERY MUCH.
>> THAT'S A GREAT QUESTION.
KARIN AND THEN ISABEL.
>> VERY NICE PRESENTATION, DOUG,
AS ALWAYS.
I'M GOING TO BRING MY QUESTION
BACK A LITTLE BIT TO THE FUNDING
STREAM AND THE ABILITY FOR US TO
TRAIN AND RECRUIT AND RETAIN OUR
JUNIOR AND SORT OF RISING
MID-CAREER INVESTIGATORS WITH P
LINES WHERE THEY ARE RIGHT NOW
WITH PAY LINES LIKE THAT, THEY
ARE ABSOLUTELY COMPETING AGAINST
ALL OF US FOR THOSE RO1s.
AND I THINK IN THE SPIRIT OF THE
FACT THAT NCI ENCOURAGES TEAM
SCIENCE, IN MANY WAYS THEY GET
PENALIZED FOR WANTING TO BECOME
AN NPI WITH A MID-CAREER OR A
SENIOR INVESTIGATOR AS ONE OF
THEIR FIRST BIG RO1 GRANTS.
WE BROUGHT THIS UP AT THE LAST
MEETING WHEN WE DID THE
SUBCOMMITTEE MEETING WITH NCAB
ON THE TRAINING.
AND I KIND OF WANT TO BRING IT
BACK TO THIS COMMITTEE BECAUSE
WE TALKED ABOUT DEVELOPING A
SUBCOMMITTEE AND REVISITING SOME
OF THE TRAINING PIPELINE AND
OVERALLING IT.
I'M NOT SURE IF AUTO GOING TO
HAPPEN.
BUT I DO THINK IN THE FACE OF
THIS, IT'S REALLY CRITICAL
BECAUSE AUTO NOT JUST ABOUT
RETAINING THE PEOPLE WHO ARE
COMING OFF TRAINING GRANTS AND
THE TRYING TO GET K AWARDS BUT
IT'S ABOUT RETAINING PEOPLE
GETTING THE FIRST AND SECOND
RO1s.
YOU'RE GOING TO LOSE YOUR
MID-CAREER ASSOCIATE PROFESSORS
TO CLINICS.
IT HAPPENS TO ME ALL THE TIME
WITH THE MDs THAT I'M, WORKING
WITH.
BECAUSE THEY ARE NOT ABLE TO GET
THAT FIRST OR SECOND RO1 WITH
THESE TYPES OF PAY LINES,
ESPECIALLY THE SECOND.
AND THEY END UP BACK IN CLINIC.
AND, WHO ARE NOT GOING INTO
CLINIC ARE GOING INTO INDUSTRY
FASTER THAN I CAN SHAKE THEIR
HAND ON THE WAY OUT OF THE DOOR.
I THINK WE NEED TO SORT OF
REVISIT THAT AND THAT I'M NOT
SEEING ANYTHING ANY TIME SOON
THAT WILL MAKE A BIG DENT ON THE
P LINES.
SO WE HAVE TO THINK ABOUT WAYS
IN THE CITIZEN TO DO THINGS
DIFFERENTLY SO THAT PEOPLE CAN
STILL WORK TOGETHER IN TEAM
SCIENCE, NOT GET PENALIZED IN
CAREERS AND DO SOME GOOD WORK.
WHERE ARE WE WITH THAT?
>> YOU'RE MUTED, I BELIEVE,
DOUG.
>> TWO RESPONSES.
SO KARIN, YOU'RE RAISING A VERY
IMPORTANT QUESTION.
FIRST, THAT WAS ONE 69 REASONS
THAT WE INCREASED THE RO1s FOR
EARLY-STAGE INVESTIGATORS WHO
WERE GIVEN AWARDS BY PAY LINE TO
BECOME R37s.
AND THIS NOW IS A 7-YEAR AWARD
RATHER THAN A 5-YEAR AWARD.
AND THE NCAB LOOKS CAREFULLY IN
CLOSED SESSION IN YEAR 4 OF THE
EARLY STAGE INVESTIGATORS.
AND BELL 90 -- ABOUT 90% OR SO
OF THE EARLY STAGE INVESTIGATORS
ARE DOING VERY WELL AND THE NCAB
THEN RECOMMENDS THAT THEY GET AN
ADDITIONAL TWO YEARS SO THEY ARE
CONVERTED TO AN R37 AWARD.
WE RECOGNIZED EXACTLY WHAT
YOU'RE SAYING ABOUT MPI AWARDS.
AND I TALKED WITH MIKED LAUER
SEVERAL YEARS AGO ABOUT NOT
HAVING THE SAME CREDIT, IF YOU
WILL, FOR AN MPI AWARD COMPARED
WITH A INDIVIDUAL AWARD.
AND HE REFUSED TO DO IT.
THIS IS AN NIH-WIDE THING.
AS FAR AS I KNOW, WE DON'T HAVE
CONTROL OVER IT.
ON THE OTHER HAND, IF THE NEXT
NCI DIRECTOR IS INTERESTED, AND
WOULD LIKE TO APPOINT ME, I
WOULD BE VERY HAPPY TO GO AND
LOOK AND DISCUSS THIS AGAIN WITH
MIKE.
OKAY?
>> THANKS.
ISABEL IF YOU COULD BE SUCCINCT
THAT WOULD BE HELPFUL TO MOVE ON
TO THE NEXT PRESENTATION.
>> I'LL GO TO PART B, DOUG, AND
THAT I THINK THAT RESOLVING THE
ISSUE OR GETTING CLOSER TO THE
ISSUE OF DIMINISHING AND GETTING
PEOPLE INTO SCREENING EARLIER IN
ORDER TO DIMINISH MORTALITY
RATES IN UNDERSERVED
COMMUNITIES, YOU NEED TO DEPLOY
BOOTS ON THE GROUND AS THEY DID
IN COVID WITH COMMUNITY HEALTH
WORKERS AND COMMUNITY-BASED
ORGANIZATIONS WHO WHEN TASKED
WITH PUBLIC HEALTH WERE ABLE TO
REALLY INCREASE BOAST TETHING
AND SCREENING.
AND I THINK THAT -- AND I KNOW
THAT THERE IS SO MUCH THAT GOES
INTO THE RESEARCH BUT IT'S TIME
TO INVEST IN COMMUNITIED BASED
ORGANIZATIONS TO GET RESULTS OF
MOVING PEOPLE FROM COMMUNITY
INTO THE SCREENINGS.
AT MULTIPLE LEVELS.
I THINK IT'S A VERY STRONG
PARTNERSHIP THAT REALLY COULD BE
VERY HELPFUL WITH NOT ONLY
COMPREHENSIVE CANCER CENTERS BUT
PUBLIC HEALTH AND CLINICS.
BUT WE NEED INVESTMENT.
WE CAN TRAIN AND DEPLOY AND
REALLY GET SOME RESULTS BUT WE
NEED THE INVESTMENT.
>> YES, THANK YOU.
>> GREAT POINT.
THANK YOU.
SO IN THE INTEREST ATIME WE'LL
MOVE ON TO THE LEGISLATIVE
REPORT THAT WILL BE BROUGHT TO
US BY MK HOLOHAN.
ISABEL, CAN YOU LOWER YOUR HAND,
PLEASE.
>> THANK YOU, AND THANK YOU FOR
THE OPPORTUNITY TO TALK WITH YOU
TODAY.
I'M GOING TO PROBABLY SKIP A FEW
SLIDES IN THE INTEREST OF TIME
SO WE HAVE THE ABILITY TO ASK
QUESTIONS.
NEXT SLIDE.
I WANT TO REMIND YOU THAT I'M
ALWAYS HAPPY TO TALK WITH YOU OR
STAFF IF YOU HAVE ANY QUESTIONS.
I'M GOING TO TOUCH ON THESE
TOPICS, FY24 APPROPRIATIONS
PROCESS, SOME OVERALL
CONGRESSIONALAL UPDATES.
I'LL PROBABLY SKIP THE RECENT
HEARINGS AND VISIT SECTIONS TO
SAVE TIME FOR QUESTIONS.
SO, FINALIZING SPENDING BILLS IS
ALWAYS A CHALLENGE.
THIS YEAR HAS BEEN MUCH WORSE
THAN USUAL.
WHEN THERE ARE PERIODIC DEBT
LIMIT INCREASES NEEDED, THAT
USUALLY IS PAIRED WITH SOME SORT
OF BUDGET DEAL.
NO EXCEPTION THIS YEAR.
IT'S ALSO DONE AT THE VERY LAST
MINUTE.
THAT'S WHAT HAPPENED.
I'M SURE YOU REMEMBER IN THE
BEGINNING OF JUNE AFTER THE
TREASURY SECRETARY WAS TALKING
ABOUT THE FULFILL AND CREDIT OF
THE UNITED STATES AND TAKING
EXTRAORDINARY MEASURES AND
CONGRESS DID COME TOGETHER WITH
A BUDGET DEAL CALLED THE FISCAL
RESPONSIBILITY ACT.
SO THIS IS THE DEBT LIMIT UNTIL
JANUARY 2025.
IT CAPPED FISCAL YEAR 24
SPENDING AT FY23 LEVELS AND
LIMITED FY25 SPENDING TO 1%
INCREASE.
SO THIS IS SOMETHING FOR
EVERYONE.
IT ALLOWED DEFENSE TO BE
INCREASED BY 3%, WHICH IS THE
AMOUNT THAT WAS REQUESTED IN THE
BUILT'S BID.
IT ALSO -- THERE WAS SIDE DEALS
THAT WERE NOT IN THE LEGISLATION
AND ALLOWED THIS TO RETURN TO
THAT ISSUE BECAUSE IT'S BECOME A
BIG POINT OF CONTENTION AS OF
TODAY.
THEY INCLUDE WHAD IS SORT OF
UNUSUAL, A STICK THAT WOULD
AUTOMATICALLY TRIGGER A CUT, A
SEQUESTER.
IF CONGRESS DOESN'T PASS ALL 12
SPENDING BILLS BY JANUARY 1,
THERE WILL BE TRIGGERED A 1%
SEQUESTER.
ACROSS-THE-BOARD.
AND THE THAT INCLUDES DEFENSE.
TO THE DOESN'T EXEMPT DEFENSE AS
SOMETIMES IS THE CASE WITH THESE
SORTS OF BUDGET DEALS.
IF THE 12 BILLS ARE NOT
COMPLETED BY APRIL 30, THEN THAT
SEQUESTER, THAT 1% CUT BECOMES
PERMANENT FOR THE REST OF THE
FISCAL YEAR.
SO, THIS IS A VERY BIG DEAL.
DEFENSE WOULD LOSE A LOT OF
MONEY IF THEY WERE HIT WITH A 1%
CUT FOR THE YEAR.
ONE THING THAT IS REALLY
INTERESTING HERE, IS THAT IT IS
UNKNOWN TERRITORY.
WE HAVEN'T HAD EXACTLY THIS
SITUATION AS FAR AS I KNOW IN
THE REPORTING.
I READ IT IS CONFIRMED.
IF THE RESOLUTION OF FY24 WAS A
FULL YEAR CONTINUING RESOLUTION
HELD KEEP ALL AGENCIES IN THAT
FULL YEAR-CR FE FY23 FUNDING
LEVEL, WOULD THAT BE CONSIDERED
COMPLETING THE APPROPRIATIONS
AND THEN NOT HAVE THOSE CUTS
TRIGGERED?
THAT IS SOMETHING THAT WE ARE
SEEING A LOT OF WRITING ABOUT
NOW.
UNFORTUNATELY, ONE THING THAT
HAPPENED ALMOST IMMEDIATELY
THERE WAS A SHORT-LIVED
CELEBRATION BY SPEAKER
McCARTHY AND OTHER LEADERS
WITHIN THE HOUSE AND SENATE,
ABOUT THE FISCAL RESPONSIBILITY
ACT BEING COMPLETED.
WITHIN A NUMBER OF DAYS OR
PROBABLY OVERNIGHT, WE STARTED
HEARING A GREAT OBJECTIONS FROM
THE HOUSE FREEDOM CAUCUS,
ULTRACONSERVATIVE FASHION OF THE
HOUSE GOP CAUCUS, AND THEY
REALLY WERE VERY UPSET ABOUT THE
FUNDING LEVEL FOR 24 AND NOT
BEING LOW ENOUGH.
THEY WANTED TO RETURN TO FY22
LEVELS.
AND SO, WE THEN SAW A DIFFERENT
APPROACH FROM HOUSE REPUBLICAN
LEADERSHIP.
THEY BEGAN TALKING ABOUT THE
FISCAL RESPONSIBILITY LEADERSHIP
FOR FY24 SETTING A SEALING, NOT
A FLOOR.
SO THEY FELT THEY WERE FREE TO
WRITE THEIR BILLS TO MUCH LOWER
LEVELS.
DEMOCRATS DID NOT VIEW IT THAT
WAY NEITHER DID SENATE
REPUBLICANS.
IT'S JUST BEEN HOUSE REPUBLICANS
THAT HAD THIS APPROACH AND THERE
WAS SORT OF A MUTINY ABOUT IT.
THERE WAS NO BUSINESS BEING ABLE
TO GET DONE ON THE HOUSE FLOOR.
THERE WAS THIS SIDE AGREEMENTS
THAT I REFERENCED THAT WOULD ADD
ABOUT -- ONE OF THE WAYS THEY
GOT TO YES WITH SOME OF THE
DEMOCRAT, ALLOWING THE 3%
INCREASE IN DEFENSE, THEY HAD TO
ALLOW FOR SIDE DEALS AND THERE
WAS ABOUT 54 MILLION DOLLARS OF
THE WHITE HOUSE REFERRED TO AS
AGREED UPON ADJUSTMENTS.
THAT'S NOT WRITTEN IN THE LAW,
IN THE FISCAL RESPONSIBILITY
ACT.
RANKING NUMBER DELORE OH, THE
TOP GEM CRACK IN THE
APPROPRIATIONS COMMITTEE, WAS
VERY SKEPTICAL ABOUT THIS AND
DIDN'T WANT THIS TO BE SORT OF A
SIDE DEAL AS IT PLAYED OUT.
SO WE ARE GOING TO COME BACK TO
THIS AND SEE HOW THIS GOES.
THERE WAS SOME GOOD NEWS THIS
MORNING THAT HOUSE FREEDOM
CAUCUS HAD STUCK WITH THEIR
LEVEL WHICH WAS FAR LOWER THAN
WHAT THE SENATE IS WRITING TO.
AND AS OF TODAY, THEY SEEM TO --
AT LEAST SOME OF OF THEM
ACKEISED TO THAT IS WHAT IS IN
THE LAW AND WHERE WE ARE GOING
TO END UP BUT THE FOCUSES IS NOW
ON THE SIDE DEALS.
IN ACCIDENT SLIDE, PLEASE.
SO I'M SURE YOU'RE ALL AWARE.
WE HAVE A NEW SPEAKER OF THE
HOUSE.
SO THIS WAS -- HE WAS FOURTH
NOMINEE TO TRY TO GET THE VOTES
NECESSARY.
NOT SOMEONE WHO HAS BEEN IN
CONGRESS FOR A LONG TIME.
I THINK A MEMBER OF THE HOUSE
FOR JUST OVER SIX YEARS.
AND THE SO HE HAS A LOT OF
REALLY DIFFICULT JOBS AHEAD OF
HIM.
RIGHT NOW, WE ARE FUNDED UNDER A
STOP GAP FUNDING BILL,
CONTINUING RESOLUTION, A CR,
AUTO AN ODD HYBRID.
IT'S BEING DESCRIBED AS A
LADDERED CR.
IT HAS TWO RUNGS.
SO THEY DIVIDED THE 12 BILLS
INTO A GROUP OF FOUR, WHICH ARE
FUNDED THROUGH JANUARY 19.
SO WE HAVE ALREADY GONE THROUGH
ONE CR.
THAT'S FINE.
NUMBER 17 WE MADE IT THROUGH
THAT.
THE SECOND ONE IS THIS ODD
LADDERED HYBRID.
SO THE FIRST FOUR ARE MILITARY
CONSTRUCTION, V.A., AGRICULTURE
AND TRANSPORTATION AND HOUSING
AND URBAN DEVELOPMENT.
SO THESE ARE FUNDED THROUGH
JANUARY 19.
ALL OF THE REST OF THE BILLS
INCLUDING LABOR HHS WHERE NIH
GETS ITS FUNDING AND THE DEFENSE
BILL, A VERY POPULAR BILL, ARE
IN THE SECOND TRENCH.
THOSE ARE FUNDED THROUGH
FEBRUARY 2.
WHAT IS NOT ADDRESSED ARE ANY OF
THE ISSUES FOR FOREIGN AID, AID
FOR ISRAEL, UKRAINE.
THERE IS A BIG PUSH AS I'M SURE
YOU HAVE READ IN ALL REPORTING
ABOUT THIS, THERE IS A BIG PUSH
FOR BORDER SECURITY PROVISIONS
TO BE ADDED TO THE AID FOR
UKRAINE.
THERE IS SOME SUGGESTION IN THE
HOUSE THAT THERE SHOULD BE SOME
SORT OF IRS PROVISIONS ADDED TO
AID FOR ISRAEL.
I DON'T WHEREIN THIS IS GOING TO
END EXCEPT BORDER SECURITY IS A
VERY BIG ISSUE AND IT'S REALLY
COMPLICATED AND IMMIGRATION
NEGOTIATIONS HAVE BEEN GOING ON
FOR YEARS AND YEARS AND REALLY
NOD BEEN ABLE TO HAVE A LOT OF
MEANING.
COMPROMISE AND MOVE THAT
FORWARD.
THIS IS CREATING A BIG PROBLEM
FOR THE NEW SPEAKER AND THE
LEADERSHIP OF THE SENATE.
SPEAKER JOHNSON MET WITH
MINORITY LEADER, MITCH
McCONNELL YESTERDAY AND IT WAS
A LARGE PART WHAT HAVE THEY WERE
DISCUSSING.
ALSO THE CR THAT WAS DONE THIS
LADDERED CR, IS A CLEAN CR.
AND THAT MEANS IS NO POLICY
RIDERS THAT WOULD BE VERY
PARTISAN AND THOSE CAN BE REALLY
KILLED AT THE CHANCE OF A CR
BECOMING ENACTED.
AND A LOT OF THE SPEAKER'S
CONSERVATIVE COLLEAGUES WERE
CONCERNED THERE WEREN'T POLICY
WRITERS AND CONTINUING THE
CURRENT FUNDING LEVEL.
THAT'S WHAT HE WAS ABLE TO GET
PASSED AND THE PLAY HE NEEDED TO
MAKE.
SO THE REASON I WANTED TO SHOW
THU TABLE IS TO SHOW YOU AS
DR. LOWY ALLUDED TO, WE ARE A
PART OF A LARGER SYSTEM.
THIS IS REFLECTING DISCRETIONARY
FUNDING.
HEALTH INSURANCE PROGRAMS LIKE
MEDICARE AND MEDICAID, SOCIAL
SECURITY, CHIP, DOESN'T REFLECT
ANY OF THIS.
THIS IS JUST DISCRETIONARY
FUNDING THAT THE HOUSE AND
SENATE APPROPRIATIONS COMMITTEES
CONTROL.
SO WE ARE IN THIS CATEGORY
HIGHLIGHTED IN YELLOW, THE LABOR
HHS FUNDING BILL.
SO THIS IS THE FY23 FINAL LEVEL.
THESE ARE DOLLARS IN MILLIONS.
THEN THE HOUSE LEVEL, THE SENATE
LEVEL AND THE DIFFERENCE.
SO HERE YOU'RE SEEING HOW THE
SENATE WROTE TO THE FISCAL
RESPONSIBILITY ACT LEVELS, THE
HOUSE CHOSE NOT TO.
AND IT'S A PRETTY SIGNIFICANT
DIFFERENCE FOR OUR BILL.
YOU GO DOWN TO THE POLT, YOU CAN
SEE THE DIFFERENCE
ACROSS-THE-BOARD.
ONE OF THE THINGS I WANTED TO
POINT OUT HERE, THESE DON'T
REFLECT THE SIDE DOLES THAT I
ALLUDED TO.
THESE ARE TOP-LINE NUMBERS.
SO THE CUTS THAT WERE AGREED TO
AND THE FLAT FUNDING FOR 24 AND
THE 1% ALLOWED INCREASE FOR '25,
THOSE ARE TOP LINE T DOESN'T
MEAN THAT EVERY PROGRAM HAS TO
BE CUT BY THAT SAME AMOUNT.
SO, APPROPRIATORS WILL USE THEIR
DISCRETION.
WHAT THIS REFLECTS HERE ARE THE
SUBCOMMITTEE ALLOCATION THAT IS
THE LEADERSHIP OF THE
APPROPRIATIONS COMMITTEES MAKE.
AND THE HOUSE AND SENATE DO NOT
MAKE THE SAME ALLOCATIONS.
THIS THE IS THE PROCESS OF THEM
WORKING OUT THE BILLS, DOLLARS,
DIRECTIVES, BUT THE JOB WAS MADE
A LOT HARDER THIS YEAR BU THE
WALKING AWAY FROM THE FISCAL
RESPONSIBILITY ACT AGREEMENTS.
SO, IT'S NOT AN ACROSS-THE-BOARD
CUT.
WE CAN'T BE OPTIMISTIC ABOUT THE
BUDGET FOR FY24 BECAUSE WE
UNDERSTAND THE MATH THAT
CONGRESS IS FACING AND THE
ALLOCATIONS THAT THE
APPROPRIATORS HAVE TO WORK WITH.
HOWEVER, I WOULD SAY WE HAVE A
TREMENDOUS AMOUNT OF BIPARTISAN
SUPPORT FOR CANCER RESEARCH.
WE ARE VERY GRATEFUL FOR THAT
AND WE CONTINUED TO BE AS
OPTIMISTIC THAT OUR SUPPORTERS
WILL CONTINUE TO PRIORITIZE SOME
OF THESE PROGRAMS AS THEY HAVE
IN THE PAST.
NEXT SLIDE, PLEASE.
SO THIS, I'M TRYING TO SHOW
HERE, THE SPECIFICS WITHIN THE
LABOR HHS BILL.
THESE ARE THE NIH, NCI AND
ARPA-H NUMBERS FOR CONTRAST.
SO THE FIRST COLUMN IS MA WE HAD
LAST FISCAL YEAR, WHAT WAS
ENACTED.
THE SECOND IS THE PRESIDENT'S
BUDGET REQUEST FOR FY24 AND THEN
THE HOUSE AND SENATE NUMBERS.
THESE ARE ONLY NOT ENACTED INTO
LAW SO THEY ARE IN GRAY BECAUSE
THEY ARE IN DEVELOPMENT.
BUT YOU CAN SEE JUST FOCUSING ON
2346789CI, THE HOUSE
SUBCOMMITTEE WOULD BE A
REDUCTION OF TWO16 MILLION
DOLLARS FOR NCI.
THIS IS NOTAISE CUT TO OUR BASE
BUDGET.
THIS IS THE -- THIS REFLECTS THE
FACT THAT THE MOONSHOT FUNDING
FROM THE CURES LEGISLATION, THAT
FUNDING LAST YEAR WAS FY23.
SO, IT LOOKS LIKE A CUT.
IT FEELS LIKE A CUT BUT FROM THE
APPROPRIATOR'S PERSPECTIVE, THEY
KEPT US FLAT.
THEY DID NOT FIND A WAY TO
BACKSTOP THAT MONEY THAT CAME
FROM A MANDATORY STREAM.
IN CONTRAST, THE SENATE DID
ALLOW FOR THAT.
AND THEY DID ACCOMMODATE PUTTING
IN THE 216 MILLION DOLLAR
INCREASE TO FILL THAT HOLE.
THEY ALSO PROPOSED A 60 MILLION
DOLLAR INCREASE ON TOP OF THAT
TO OUR BASE BUDGET.
NEXT SLIDE.
SO WHAT I WANTED TO SHOW YOU IS
THE FLUXATIONS IN OUR BASE
BUDGET.
DR. LOWY SHOWED YOU DETAIL ABOUT
THE FUNDING STREAMS AND WE HAVE
MONEY FOR THE CANCER MOONSHOT
AND WE HAD MONEY FOR CCDI FOR
THESE SPECIFIC PROGRAMS.
THIS SLIDE JUST SHOWS THE BASE
BUDGET AND YOU CAN SEE THERE IS
SIGNIFICANT VARIATIONS IN THE
AMOUNT OF INCREASES WE RECEIVED.
AND YOU IS CAN SIGH IN FY19 IT
WAS A 79 MILLION DOLLAR
INCREASE.
CONTRASTING THAT FY20 WITH A
VERY LARGE INCREASE AND WE
WANTED TO POINT OUT THIS IS WHEN
THERE WAS THE FIRST CLIP FOR
CANCER MOONSHOT FUNDING.
IT DROPPED FROM 400 MILLION THE
YEAR PRIOR TO 195 MILLION IN
FY20.
SO THE APPROPRIATOR FOUND A WAY
TO RESCUE US FROM THE FUNDING
CLIFF.
SO THAT WAS VERY GOOD NEWS FOR
US.
OBVIOUSLY THESE WERE GREAT
PROGRAMS AND WE WANTED TO
CONTINUE.
BUT, HAVING DIFFERENT FUNDING
STREAMS MAKES IT COMPLICATED.
SO WE WANTED TO POINT THAT OUT
HERE.
SO WHAT HAPPENS HERE?
NEXT?
FOR THE FIRST TIME WE DO NOT
HAVE A FUNDING CRISIS LOOMING
RIGHT BEFORE THE CHRISTMAS
HOLIDAY.
AND THAT'S GREAT FOR ALL THE
REPORTERS THAT COVER CONGRESS
FOR THE MEMBERS THEMSELVES.
BUT ALL IT REALLY DOES IS PUNT
IT TO THE NEXT MONTH.
AND THERE IS NOT A LOT OF TIME
LEFT.
SPEAKER JOHNSON WILL NOT VIEW
ANOTHER PLEA FUNDING BILL.
SO IF WE STICKS TO THAT, THAT
REALLY LIMITS HIS OPTIONS.
IT'S EITHER GET THESE BILLS DONE
FOR REAL AND FINALIZED OR DO EYE
FULL-YEAR CR.
WE'LL SEE.
THEY DON'T HAVE A LOT OF TIME TO
RECONCILE THESE BILLS AND AS YOU
SEEK FROM THE TABLE WITH ALL OF
THE REALLY CONTRASTING TOP LINE
NUMBERS, THEY HAVEN'T CERTAINLY
BEGUN TO COME TO AGREEMENT ON
THESE BILLS.
THE LATTER HYBRID CR WE HAVE HAS
TWO DATES FOR POSSIBLE
SHUTDOWNS.
WE COULD HAVE A PARTIAL
GOVERNMENT SHUTDOWN ON JANUARY
19 AND THEN WE COULD HAVE
ANOTHER PARTIAL GOVERNMENT
SHUTDOWN ON FEBRUARY 2 BECAUSE
THERE ARE THESE DIFFERENT
TIMEFRAMES FOR WHICH FEDERAL
PROGRAMS ARE FUNDED.
THE CHASM BETWEEN THE HOUSE AND
SENATE CEALING, NOT A FLOOR
ISSUE.
MAYBE THAT'S COMING CLOSER TO
RESOLUTION.
WE DID SEE SOME POSITIVE NEWS ON
THAT TODAY.
BUT THEN THERE IS THE SIDE DEAL
ISSUES.
AND SO THAT WOULD CERTAINLY BE A
PROBLEM.
HOWEVER, THAT PLAYS OUT.
OTHER BIG PROBLEMS THAT CONGRESS
HAS TO DEAL WITH ARE FOREIGN AID
ISSUES.
PARTICULARLY THE BORDER SECURITY
DEMANDS ARE GOING TO BE VERY
DIFFICULT.
HOUSE AND SENATE REPUBLICANS DO
SEEM TO BE UNITED ON INSISTING
THAT THEY WANT BORDER SECURITY
PROVISIONS TO BE PART OF ANY
DEAL FOR UKRAINE.
AND THERE ARE OTHER MACHINES WHO
ARE DETERMINED THAT AID TO
UKRAINE WILL BE CONDITIONED ON
GETTING AID TO ISRAEL FIRST.
SO, AS I'M SURE YOU KNOW FROM
ALL OF THE REPORTING ABOUT THOSE
TWO ISSUES, THIS IS CAUSING A
LOT OF FASHIONS FOR BOTH SIDES
SO IT WILL NOT BE RESOLVED
QUICKLY OR EASILY.
NEXT SLIDE, PLEASE.
I WANTED TO POINT OUT, YRs ARE
VERY COMMON.
AN AVERAGE OF 5 PER YEAR.
I LIKE THIS SLIDE BECAUSE IT
SHOWS THE DURATION OF HOW LONG
THE CRs ARE AND I WANT TO
POINT OUT THE 365 DAYS, THAT
INDICATES THAT THERE WERE AT
LEAST SOME GOVERNMENT BILLS
FUNDED IN A FULL-YEAR CR.
NOT ALL OF THEM.
DEFENSE HAS ALWAYS FOUND A WAY
TO BE FUNDED BY A SUBSEQUENT
APPROPRIATION.
THAT HAS NOT BEEN THE WAYS FOR
ALL OF THE SUB COMMITTEE
ALLOCATIONS OR BILLS.
AND THIS DOESN'T SHOW YOU 2023.
THERE WERE THREE CRs THAT WENT
90 DAYS INTO THE FISCAL YEAR.
ALL OF YOU KNOW VERY WELL, THE
LONGER INTO THE FISCAL YEAR WE
HAVE UNCERTAINTY ABOUT OUR
FUNDING LEVELS, THE MORE
DIFFICULT IT IS TO PLAN BOTH FOR
NCI AND FOR THE GRANTEES AND SO
THAT IS SOMETHING WE WOULD
REALLY HOPE DOESN'T EXTEND
TERRIBLY LONG.
SINCE WE ARE FUNDED THROUGH A CR
UNTIL FEBRUARY 2, THAT WOULD BE
THE EARLIEST WE WOULD POSSIBLY
GET OUR 24 APPROPRIATION
SETTLEED.
AND I DON'T KNOW WHAT THE ODDS
ARE THAT WILL BE THE FINAL
RESOLUTION.
NEXT SLIDE.
YOU'RE SEEING A LOT OF NEWS
ABOUT RETIREMENTS.
THE NUMBER OF THE ACCUMULATIVE
NUMBERS ARE NOT ALL THAT OUT OF
THE ORDINARY.
THERE IS A LOT OF FLUX.
ONE THING THAT IS OUT OF THE
ORDINARY IS THE LEVEL OF
INSTITUTIONAL KNOWLEDGE THAT IS
LEAVING, THESE INDIVIDUALS THAT
ARE LEAVING.
I WANTED TO HIGHLIGHT A FEW
MEMBERS HERE.
ON THE TOP RIGHT IS
CONGRESSWOMANNA OF CALIFORNIA.
SHE IS A FIERCE CHAMPION OF
BIOMEDICAL RESEARCH.
AND THEN THE NEXT TWO
PHOTOGRAPHS GOING
COUNTERCLOCKWISE ARE CONGRESSMAN
BRIAN HIGGINS OF NEW YORK AND
REPRESENTATIVE DERRICK KILMER OF
WASHINGTON STATE STANDING WITH
DR.-- THEY BOTH WERE CHAIRS OF
THE HOUSE CANCER CAUCUS AND VERY
SUPPORTIVE OF CANCER RESEARCH
AND WORKED CLOSELY WITH NCI AND
LOTS OF THE CANCER GROUPS LIKE
ACS HAD HAD REALLY GOOD
RELATIONSHIPS WITH THEM AS WELL.
IT'S JUST A LOSS FOR US.
THEN CONGRESSWOMAN KATE
GRAINGER, CHAIR OF THE FULL
APPROPRIATIONS COMMITTEE IN THE
HOUSE IS RETIRING.
AND SENATOR JOE MANSION
ANNOUNCED HIS SEAT WILL FLIP
FROM BLUE TO RED.
THAT THE IS A SIGNIFICANT ISSUE
FOR SENATE DEMOCRATS.
SOME OF THE ASSESSMENTS HAVE
LOOKED AT OVER TIME IN CONGRESS
HAD BEEN IN OFFICE FOR LESS THAN
5 YEARS.
BY WENT TOY BETWEEN, ALMOST 47%
OF HOUSE MEMBERS WERE THERE LESS
THAN 5 YEARS.
NANCY PELOSI SERVED FOR 20
BEFORE SHE BECAME SPEAKER.
PAUL RYAN FOR 17.
McCARTHY FOR 17.
IT'S JUST A LOT.
I GUESS THE HOPE IS THAT PEOPLE
WHO HAD MORE EXPERIENCE AND ABLE
TO DO MORE BIPARTISAN WORKING
KEEP DOING THAT AND KEEP
AVOIDING SOME OF THE EMERGEN
EMERGENCIES.
NEXT SLIGHTED.
WE TRY VERY HARD TO POST MEMBERS
OF CONGRESS TO VISIT AND THEIR
STAFF TO VISIT NCI TO WORK WITH
SITES TO HAVE, IF WE COULD BE
HELPFUL UPONFUL TO HAVE SOLICITS
TO NCI-FUNDED INSTITUTIONS AND
THAT'S WHAT THESE SLIDES
REPRESENT.
I'M GOING TO LEAVE THESE FOR
YOU.
THIS WAS A TERRIFIC BRIEFING
THAT OUR COLLEAGUES AGAINST
CANCER, GROUP ORGANIZED THROUGH
ACS CAN AND THEY PUT TOGETHER A
TERRIFIC BRIEFING ON CAPITOL
HILL THAT WAS REALLY WELL
INTENDED BY CONGRESSIONAL STAFF.
LAST SLIDE.
AND IF WE HAVE ANY TIME FOR
QUESTIONS, I JUST WANTED TO
THANK ALL OF YOU WHO WORKED TO
ENGAGE AND INFORM MEMBERS OF
CONGRESS AND THEIR STAFF AT YOUR
OWN INSTITUTIONS AND WHEN YOU'RE
DOING VISITS ON CAPITOL HILL,
BECAUSE IT IS -- IT REALLY
MATTERS.
IT'S VERY HELPFUL FOR THAT
CONTEXT FOR MEMBERS TO HAVE THAT
AND THEIR STAFF TO LEARN ABOUT
THE KIND OF WORK THAT NCI IS
SUPPORTING AND THE KIND OF WORK
THAT IS HAPPENING.
THANK YOU.
HAPPY TO HEAR FROM ANY OF YOU
HERE OR WHEN YOU HAVE TIME AFTER
THE MEETING.
>> ARE THERE GO BURNING
QUESTIONS FOR MK?
FOR ME THE QUESTION WOULD BE, AS
YOU LOOK BACK ON THOSE FULL 365
DAY CRs HOW HAS HHS TYPICALLY
FAIRED?
WE TALK ABOUT THE VARIOUS BILLS,
DOD, DEFENSE ALWAYS, BUT HOW
HAS --
>> NOT LABOR HHS.
OUR BILL IS ALWAYS ONE OF THE
LAST TO GET DONE.
IT IS THE BIGGEST DISCRETIONARY,
NON-DEFENSE DISCRETIONARY BILL.
AND IT IS FULL OF POLICY RIDERS
THAT ARE CONTROVERSIAL.
AND THIS YEAR THERE IS LOTS OF
BILLS THAT HAVE CONTROVERSIAL
RIDERS, AGRICULTURE BILL IS
REALLY PROBLEMATIC.
AND THAT IS THE IN THE FIRST
TRAUNCH INTENDED TO BE AN EASIER
GROUP TO GET THROUGH.
THERE IS RESTRICTIONS ABOUT
ACCESS TO THE -- I CAN NEVER
PRONOUNCE THE NAME.
SO THERE WAS RETAIL RESTRICTIONS
ABOUT THAT AND SOME MODERATE
REPUBLICANS VOTED AGAINST IT AND
SAID THEY WOULD NOT SUPPORT THAT
AG APPROPRIATIONS BILL AND THAT
IS HOLDING UP FDA'S
APPROPRIATION.
SO, WE ARE NEVER GOING TO BE THE
FIRST OR EXEMPTED FROM A FULL CR
BECAUSE OUR BILL IS TOO
DIFFICULT TO GET DONE
POLITICALLY.
>> AND I'LL ALLOW WONG QUESTION.
RAY?
>> SO THANKS FOR THIS BRIEFING.
IT'S ALMOST LIKE A SKY IS
FALLING BRIEFING ALL OVER AGAIN.
>> THERE WAS SOME GOOD NEWS
TODAY.
NOT A LOT BUT --
>> SO, MY QUESTION IS, WHAT IS
THE DOOMSDAY SCENARIO?
HOW REALISTIC IS IS IT?
AND OTHER THAN DOING THE ONE
VOICE AGAINST CANCER ON CAPITOL
HILL EVENTS, WHICH PRETTY MUCH
MOST OF US DO, WHAT CAN WE BE
DOING TO HELP FOSTER
UNDERSTANDING?
MAYBE MOVE DIALOGUE?
IS THERE ANYTHING OR ARE WE
TOTALLY HELPLESS WAITING FOR THE
SKY TO FALL?
>> SO THE LAST QUESTION FIRST.
I THINK THERE ARE GROUPS WHO CAN
DO WHAT IS ESSENTIALLY LOBBYING,
THAT IS NOT SOMETHING FEDERAL
AGENCIES CAN DO BUT WHAT WE --
WHAT I SEE THE MOST VALUE IN, MY
PERSONAL OPINION, IS REALLY JUST
THE ENGAGEMENT.
WHEN I SEE THE OVAC EVENT,
DR. LOWY WAS THERE.
A RESEARCHER FROM NORTHWESTERN
CANCER CENTER, DR. ADAM, HE
SHOWED A VIDEO OF THIS REALLY
INTERESTING RESEARCH HE'S DONE
ABOUT GETTING THROUGH THE BLOOD
BRAIN BABIER FOR NEURO-ONCOLOGY
CASES, PEOPLE -- NON-SCIENTISTS
IN THE AUDIENCE WERE AMAZED.
AND THAT'S NOT THE KIND OF THING
YOU CAN BRING PEOPLE TO THE
CLINIC TO SHOW THEM.
THEY HAD A TERRIFIC VIDEO.
DOING THAT SORT OF -- SAME
THINGS THAT ARE REAL AND THINGS
THAT ARE TAVERN AND I BELIEVE
CONNECTED TO PATIENTS, HAS A LOT
OF RESONANCE WITH STAFF AND
MEMBERS FROM WHAT I HAVE SEEN
OVER THE YEARS I HAVE BEEN
WORKING AT NCI.
I DON'T THINK THERE IS A -- I'M
NOT GOING TO GIVE A DOOMSDAY, A
FULL-YEAR CR OR STAYING FLAT,
FLAT IS NOT FLAT.
EXPENSES CONTINUE AND SO IT IS A
DECREASE IN RESOURCES.
BUT I THINK IN SOME WAYS, HAVING
A SENSE OF THE LONG GAME, CANCER
RESEARCH TAKES TIME AND WE MAY
HAVE A YEAR THAT DOESN'T HAVE AS
MANY OPPORTUNITIES FOR NEW
STARTS BUT I THINK ONE OF THE
MOST POWERFUL MESSAGES I HEARD
SCIENTISTS AND PEOPLE THAT WORK
IN THEIR LABS AND PATIENTS ON
CLINICAL TRIALS AND CONGRESS, IS
AN IDEA THAT STARTS IN THE LAB
THAT IS DOING VERY BASIC WORK.
CAN END UP BEING TRANSFORMATIVE
FOR PATIENTS IN SHORTER AND
SHORTER INTERVALS AND SOME OF
THAT IS SO POWERFUL.
AND THOSE ARE VERY POWERFUL
EVENTS EACH FOR A JADED CAPITOL
HILL AUDIENCE, I THINK PEOPLE
FEEL REALLY GOOD ABOUT
SUPPORTING CANCER RESEARCH WHEN
THEY CAN SEE THAT IMPACT.
>> THANK YOU.
IT'S ALWAYS SO INFORMATIVE AND
SO HELPFUL FOR US TO UNDERSTAND
ABOUT THE PERSPECTIVE AROUND THE
BUDGET.
SO, WE'LL MOVE ON TO THE NEXT
AGENDA ITEMS ITEM, RECOGNITION
OF RETIRING BOARD MEMBERS.
THAT WILL BE LED BY DOUG.
>> THANK YOU, JOHN.
WE ARE REALLY BLESSED TO HAVE
AMAZING MEMBERS OF BOTH BOARDS.
IT'S A BITTER SWEET MOMENT
BECAUSE YOU CONTRIBUTE SO MUCH
TO WHAT WE DO.
BUT OBVIOUSLY DR. FLAHERTY HAS
BEEN THE LEDDER OF THE BSA AND
THE HAS DONE AN AMAZING JOB WITH
THAT POSITION.
DR. BRAWLEY, TELLING US HIS
EXPERIENCES, BECAUSE HE HAS SO
MUCH DIFFERENT KIND OF
EXPERIENCE.
DR. KNUDSEN, FIRST AS LEADER OF
THE JEFFERSON CANCER CENTER AND
NOW AT ACS AGAIN, WEALTH OF
EXPERIENCE AND DR. SIDRANSKY
WITH HIS SPECIAL EXPERTISE IN
HEAD AND NECK AND OTHER CANCERS.
DR. SIDRANSKY IS NOT HERE TODAY
BUT DR. FLAHERTY, BRAWLY AND
KNUDSEN, ALL WHO HAVE SPOKEN AND
HAVE BEEN HELPFUL TODAY AND AT
OTHER TIMES.
WE REALLY APPRECIATE ALL THAT
YOU HAVE DONE FOR US AND I'M
ONLY REGRET THAT THIS HAS TO BE
A VIRTUAL MEETING RATHER THAN IN
PERSON.
THANK YOU.
>> THANK YOU ALL FOR YOUR
SERVICE, FOR SURE.
AND I'M SURE YOU'LL ALL REMAIN
HIGHLY ENGAGED IN CANCER
RESEARCH.
SO THANKS, DOUG.
SO THE LAST AGENDA ITEM DURING
THIS SECTION OF THE MEETING WILL
BE A PRESENTATION, INVESTIGATOR
ROLE CDK4/6 ACTIVITY DURING CELL
CYCLE LIVE-CELL IMAGING BY
STEPHEN CAPPEL WHO IS AN NIH
INVESTIGATOR WITHIN THE CENTER
FOR CANCER RESEARCH AT NCI.
>> THANK YOU FOR THE
INTRODUCTION.
I WILL SHARE MY SCREEN.
SO THANK YOU FOR THE OPPORTUNITY
TO PRESENT MY LAB'S WORK ON
UNDERSTANDING THE PRINCIPLES OF
CELL CYCLE REGULATION.
IT'S IT'S NEEDED TO REPAIR
WOUNDS, AND TO MOUND AN
EFFECTIVE IMMUNE RESPONSE.
WHEN THIS PROCESS GETS BROKEN IT
CAN LEAD TO CANCER OR
DEGENERATIVE DISEASES.
THE GOALS OF MY LAB AT THE NCI
ARE TO INVESTIGATE THE
FUNDAMENTAL MOLECULAR MECHANISM
THAT REGULAR CELL CYCLE ENTRY
AND EXIT, TO UNDERSTAND HOW THEY
GET BROKEN AND CONTRIBUTE TO
HUMAN DISEASE AND TO HOPEFULLY
TRANSLATE OUR FINDINGS TO
DEVELOP NEW OR IMPROVED
CHEMOTHERAPIES FOR CANCER
PATIENTS.
THE CELL CYCLE IS WIDELY KNOWN
THAT PROPER PROGRESSION IS
REGULATED BY A SERIES OF
CHECKPOINTS THAT CONTROL
PROGRESSION FROM EACH STAGE OF
THE CELL CYCLE TO THE NEXT.
THE LAST 20-30 YEARS, A LOT OF
BIOCHEMICAL AND GENETIC
APPROACHES HAVE BEEN USED TO
ELUCIDATE 340 ELECULAR MECHANISM
THAT APPEAR TO ACCOUNT FOR A LOT
OF THESE ACCOUNTS.
NOT SURPRISING THAT MOST OF THE
CHEMO THERAPEUTIC AND TARGETED
AGENCY THAT ARE USED IN CANCER
TREATMENT ARE TARGETING THESE
CHECKPOINTS.
BUT ONE OF THE MAIN PROBLEMS IN
THE CLINIC IS THAT MANY OF THESE
CHEMOTHERAPEUTICS DESPITE BEING
VERY SUCCESSFUL IN THE CLINIC,
OFTEN DON'T WORK EXACTLY AS WE
PREDICTED BASED ON THESE MODELS.
FOR EXAMPLE, THERE IS
HETEROGENOUS RESPONSEES FROM
CELLS IN THE TUMOR WHERE YOU CAN
ONLY GET FRACTIONAL KILLING THAT
CAN LEAD TO REOCCURRENCE OF THE
TUMOR.
YOU ALSO GET UNEXPECTED
COMPENSATORY MECHANISMS THAT CAN
LEAD TO RESISTANCE.
AND SO THIS PROBLEM HIGHLIGHTS
THAT MAYBE THESE MOLECULAR
MECHANISMS ENSHRINED IN
TEXTBOOKS AREN'T REALLY GIVING
US THE PICTURE FOR UNDERSTANDING
HOW THE CELL CYCLE WORKS.
ONE OF THE MAIN PROBLEMS
LIMITING OUR FULL UNDERSTANDING
OF THESE PROCESSES IS A LOT OF
THESE MECHANISMS WERE ELUCIDATED
USING BIOCHEMICAL TECHNIQUES AND
THESE CHECKPOINTS ARE STUDIED AT
THE LEVEL OF CELL BIOLOGY.
ONE OF THE MAJOR CHALLENGES IN
THE REACH IS HOW TO LINK THESE
MECHANISMS TO THE CELL
BIOLOGICAL PROCESSES INVOLVED IN
THE CELL CYCLE?
AND SO MY LAB AT THE NCI TRIES
TO ADDRESS THESE CHALLENGES BY
ENGINEERING NEW AND USING
CURRENT FLUORESCENT BIOSENSORS
FOR THESE ENZYMES IN THE
PATHWAYS THAT CONTROL
PROGRESSION THROUGH THE CELL
CYCLE.
USING THESE BIOSENSORS, WE CAN
MONITOR THE ACTIVITY OF THESE
PATHWAYS IN LIVE SINGLE-CELLS AS
THEY DYNAMICALLY PROGRESS FROM
EACH STAGE OF THE CELL CYCLE TO
THE NEXT.
AND SO THIS APPROACH ALLOWS US
TO MEASURE IN THOUSANDS OF CELLS
AT THE SAME TIME THE ENZYME
ACTIVITIES THAT ARE KEY FOR CELL
CYCLE CONTROL.
THEN WE TREAT THESE CELLS WITH
SMALL MOLECULE INHIBITORS OR
THERAPEUTIC AGENTS AND TRY TO
UNDERSTAND HOW THESE ENZYME
ACTIVITIES ARE CHANGING
DYNAMICALLY AND IN REALTIME.
WE COMBINE WITH AUTOMATED TIME
LAPSE IMAGING ANALYSIS PIPELINE
THAT ALLOWS US TO CONVERT THESE
RAW IMAGES FROM THE MICROSCOPE
INTO SINGLE CELL TIME SERIES
DATA.
THIS GIVES US A QUANTITATIVE AND
DYNAMIC READ OUT OF THESE
MOLECULAR MECHANISMS IN CELLS.
TO GIVE YOU AN IDEA OF HOW THESE
BIOSENSORS WORK, I CAN EXPLAIN
HOW ONE OF OUR MAIN BIOSENSORS
WORK.
THIS IS FOR PROTEIN CYCLIN
DEPENDENT KINASE 2, A MAIN
REGULATOR OF CELL CYCLE
PROGRESSION.
CDK2 IS A KINASE AND ONE OF THE
NO ONE SUBSTRATES OF CDK2 IS DNA
HELICASE B.
WE FUSED THE C TERMINIS OF DNA
HEEL CASE B TO A FLUORESCENT
PROTEIN.
AND IN THE C TERMINIS IT HAS
FOUR POTENTIAL PHOSPHORYLATION
SITES AS WELL AS NUCLEAR
LOCALIZATION SEE EXPENSE IS AND
NUCLEAR EXPORT SEQUENCE.
IT TURNS OBJECT WHEN THIS
PEPTIDE IS NOT PHOSPHORYLATED,
THE NUCLEAR LOCALIZATION
SEQUENCE DOMINATES AND
BIOSENSORY SIDES IN THE NUCLEUS.
WHEN THE KINASE TURNS ON AND
PHOSPHORYLATES, THE NEGATIVE
CHARGES TIP THE BALANCE AND THE
BIOSENSORY GETS EXPORTED INTO
THE CYTOPLASM.
SO WE CAN LOOK AT THE
LOCALIZATION OF THE BEEO SENSOR
AS IT MOVES FROM THE NUCLEUS
INTO THE CYTOPLASM AS A READ OUT
FOR CDK2 ACTIVITY.
WE CAN QUANTIFY THIS USING IMAGE
ANALYSIS PINE LINE BY MEASURING
FLUORESCENCE IN THE CYTOPLASM BY
TAKING THE RATIO OF THE VALUES
TO GIVE US A READ OUT OF CDK2
ACTIVITY.
I'M SHOW A MOVIE HERE.
THIS CELL WILL START OUT WITH
HIGH CDK2 ACTIVITY T WILL GO
THROUGH MITOSIS WHEN THE
ACTIVITY RAPIDLY DROPS AND THEN
CDK2 ACTIVITY WILL SLOWLY RAMP
UP OVER THE COURSE OF THE CELL
CYCLE AND THEN REACHES ANOTHER
MITOSIS AND FALLS AGAIN
REPEATING THE CYCLE.
YOU'LL SEE THIS STEREOTYPICAL
SAW TOOTH PATTERN NORMAL FOR
PROTEINS THAT ARE REGULATED
THROUGHOUT THE CELL CYCLE.
I CAN SHOW YOU THAT CELL AGAIN.
IT WILL DROP IN MITOSIS.
WHY.
DK2 TERPS ON AND WILL RAMP UP
THROUGHOUT THE CELL CYCLE.
WE MEASURE MANY CELLS
SIMULTANEOUSLY AS THEY ARE GOING
THROUGH THE CELL CYCLE.
HERE ARE 10 THAT ARE
HETEROGENOUSLY PROGRESSING
THROUGH THE CELL CYCLE AT THE
SAME TIME.
I HOPE YOU APPRECIATE HOW A
COMPLICATED MESS LOOKING AT ALL
10 OF THESE CELLS IS AT A TIME.
IT'S WORSE WHEN YOU LOOK AT 100
CELLS.
YOU SEE THIS HUGE HAIR BALL OF
HETEROGENEITY.
WE CAN MAKE SENSE OF THIS
HETEROGENEITY BY IN SILICO
SYNCHRONIZING THESE CELLS TO
MITOSIS.
WHEN YOU DO THIS, WHAT EMERGES
FROM THAT HEALTH GENIUS DATA IS
TWO SUBPOPULATIONS OF CELLS THAT
BEHAVE QUITE DIFFERENTLY.
SOME CELLS WILL IMMEDIATELY EXIT
MITOSIS AND TURN CDK2 ON
INDICATING THAT I HAVE ENTERED
THE CELL CYCLE.
AND SOME SELLS LEAD TURN CDK2
OFF.
AND SO THESE BIOSENSOR ARE COOL.
THEY ALLOW US TO MAKE SENSE OF
THIS HETEROGENOUS BEHAVIOR AND
IDENTIFY THE SUB POPULATIONS AND
ALLOW US TO VISUALIZE WHEN CELLS
ARE MAKING THESE DECISIONS AND
TRAPSITIONS.
YOU CAN SEE AT THE POINT WHEN
THESE DIFFERENT POPULATIONS
DIVERGE, THAT'S WHEN THESE CELLS
WERE MAKING THIS DECISION.
SO OPENING MY LAB IN 2018, WE
USED THIS APPROACH TO STUDY
FUNDAMENTAL PRINCIPLES OF CELL
CYCLE REGULATION.
THE G1S CHECKPOINT, CELLS DON'T
JUST ARREST IN RESPONSE TO DNA
DAMAGE BUT IN FACT CELLS TAKE
DIVERGENT PACKS AFTER DNA
DAMAGE.
SOME CELLS WILL GO BACKWARDS
THROUGH THE CELL CYCLE AND
RETURN TO QUIESCENCE SO THEY CAN
REPAIR THE DAMAGE.
OTHER CELLS MOVE FORWARD THROUGH
THE CYCLE AND ENTER INTO S
PHASE.
AND WE THINK THIS IDEA THAT
CELLS ALL ARRESTED AT THE
TRANSITION REALLY JUST AN
ARTIFACT OF BULK CELL ANALYSIS
WHERE YOU COMBINE THE CELLS WITH
OPPOSITE PHASE INTO ONE SAMPLE.
SO LOOKING AT THESE WITH SINGLE
CELL RESOLUTION IS KEY FOR
UNDERSTANDING THESE MECHANISMS.
WE LOOK AT A FORM OF
IRREVERSIBLE, SINESENCE.
WE USED A DRUG COMBINATION SHOWN
TO INDUCE SENESCENCE.
WE IDENTIFIED A MECHANISM WHERE
mTOR REGULATES A LIGASE
CONTROLLING THE CELL CYCLE WHICH
IN TURN REGULATES GLYCOLYSIS.
THIS GIVES CELLS A BOOST THEY
NEED TO GET THROUGH THE FIRST
CELL CYCLE.
IN ADDITION TO THESE
QUESTION-BASED PROJECTS, WE ALSO
ARE INTERESTED IN TOOL
DEVELOPMENT THAT CAN BE USED BY
THE SCIENTIFIC COMMUNITY.
WE DEVELOPED A NEW BIOSENTENCOR
FOR THE LIGASE BETA TRCP
UPREGULATED IN MANY CANCERS AND
CONSIDERED AN ONCOGENE.
WE USED THIS BIOSENSOR IN
COLLABORATION WITH NCATS TO DO
HIGH-THROUGHPUT SMALL MOLECULE
SCREENS TO SEE IF WE CAN
IDENTIFY INHIBITORS THAT COULD
BE USED IN THE CLINIC.
SO IN THE 70s AND 80s, IT
WAS DESCRIBED THE POINT WHEN
CELLS APPEARED TO BE
IRREVERSIBLE COMMITTED TO THE
CELL CYCLE.
THIS IS THE RESTRICTION POINT.
THIS MEANS IF A CELL IS BEFORE
THE RESTRICTION POINT WHEN MIGHT
JEN SIGNALING IS LOST, THE CELL
WILL GO QUIESCENT.
IF A CELL IS AFTER THE
RESTRICTION POINT WHEN THE
SIGNALS IS LOST, IT'S THOUGHT TO
BE IRREVERSIBLY COMMITTED TO THE
CELL CYCLE AND WILL COMPLETE THE
CYCLE AND DIVIDE INTO DAUGHTER
CELLS AND IT'S THE DAUGHTER
CELLS THAT WILL GO QUIESCENT.
THE MOLECULAR MECHANISM THOUGHT
TO UNDERLIE THIS PROCESS HAS
BEEN WELL CHARACTERIZED OVER THE
LAST 20-30 YEARS.
IT INVOLVES A FEED BACK LOOP
WITH THE TUMOR SUPPRESSOR
PROTEIN, A FAMILY OF
TRANSCRIPTION FACTORS AND THE
AFOREMENTIONED CDK2.
AND HOW THIS PROCESS WORKS IS
THAT CDK4 AND 6 ARE REVERSIBLY
ACTIVATED BY UPSTREAM MAP KINASE
SIGNALING.
ONCE CDK4/6 IS ACTIVE IT
INHIBITS THE RB AND LEADS TO
TRANSCRIPTIONAL PROGRAM THAT
ACTIVATES CDK2.
AND CDK2 ITSELF CAN
PHOSPHORYLATE THUS COMPLETING
THE FEEDBACK LOOP.
ONCE THIS FEEDBACK LOOP IS
ACTIVE, IT SELF SUSTAINING AND
ACTIVE.
THAT'S BECAUSE YOU CAN BLOCK
UPSTREAM CDK4/6 OR MIGHT JEN
SIGNALING AND THIS PATHWAY SILL
REMAINS ACTIVE.
IT IS IMPORTANT TO NOTE THAT
THIS MOLECULAR MECHANISM IS THE
CLINICAL RATIONAL FOR A WIDE
VARIETY OF TARGETED AGENTS THAT
ARE USED IN THE CLINIC INCLUDING
CDK4/6 INHIBITORS, MEK
INHIBITORS AND TYROSINE KINASE
INHIBITORS.
THE POSTDOC IN THE LAB FOUND
THAT THIS PATHWAY IS NOT IR
REVERSE IB.
WE CAN FULLY REVERSE IT AND
THAT'S BECAUSE CDK4/6 AND MIGHT
JEN SIGNALING PATHWAYS ARE
REQUIRED FOR THE ENTIRE CELL
CYCLE.
AND BY TREATING WITH INHIBITORS,
WE CAN FORCE CELLS INTO
QUIESCENCE FROM ANY POINT IN THE
CELL CYCLE.
THIS OBSERVATION WAS USED USING
LIVE-CELL IMAGING PLATFORM.
TWO EXAMPLES OF CELLS THAT
BEHAVE DIFFERENTLY.
THESE CELLS ARE EXPRESSING CDK
BIOSENSOR AND APC BIOSENTENCOR
THAT ALLOWS US TO MONITOR THE
STATUS OF THIS FEEDBACK LOOP
THAT IS SUPPOSED TO BE
UNDERLYING RESTRICTION POINT
PHENOMENON.
HERE IS THE CELL T WILL START
OFF IN G2 PHASE AND GO THROUGH
MITOSIS AND THANSITION AND THEN
HITS WITH A CDK4/6 INHIBITOR.
THIS CELL WILL MAKE IT TO
MYOSETOSIS AND DIVIDE INTO TWO
DAUGHTER CELLS AND IT'S THE
DAUGHTER CELLS THAT HAVE ENTERED
INTO QUIESCENCE.
WE KNOW THAT BECAUSE THEY HAVE
BIOMARKERS FOR QUIESCENCE.
SO THIS CELL BEHAVED AS YOU
WOULD PREDICT FROM THE MODEL.
BUT WE ALSO SEE MANY CELLS THAT
TAKE A DIFFERENT AND UNEXPECTED
TRAJECTORY THROUGH THE CELL
CYCLE.
SO THIS CELL WILL START OFF VERY
SIMILAR TO THE OTHER CELL IN G2
PHASE AND GO THROUGH MITOSIS AND
THE TRANSITION AND THEN IT WILL
GET HIT WITH THE CDK64
INHIBITOR.
OF THIS CELL DOES SOMETHING
DIFFERENT.
RATHER THAN REACH MITOSIS, IT
SPONTANNUOUSLY LOST THE CDK TWO
ACTIVITY AND RE-ACTIVATED.
APC.
THIS CELL ENTERED A G0 LIKE
STATE.
IF YOU JUST LOOK AT THE END OF
THE MOVIE, BIOCHEMICALLY IT'S
VERY SIMILAR TO THE OTHER TWO
CELLS.
HIGH APC ACTIVITY AND LOW CDK2
ACTIVITY.
AND IF WE FIX AND STAIN THESE
CELLS FOR A THIRD MARKER OF
QUIESCENCE, WE SEE THAT BOTH
TRAJECTORIES RESULT IN LOW
PHOSPHOR B.
THE CELL THAT TOOK THE WEIRD
TRAJECTORY THROUGH THE CELL
CYCLE ENDED UP WEAPON A EXTRA
COPY OF DNA CONTENT.
AND THAT'S BECAUSE IT SKIPPED
MITOSIS.
AND SO WE WONDERED WHAT SETS THE
SMALL 10% OF CELLS APART FROM
THE OTHER CELLS?
WHY DO THEY TAKE THIS DIFFERENT
TRAJECTORY AND WHY DIDN'T THEY
BEHAVE AS EXPECTED BY THE
RESTRICTION POINT MODEL?
AND ONE CLUE THAT LED US TO THE
ANSWER THO THIS QUESTION WAS
JUST LOOKING AT THE RELATIVE
TIMING IT TAKES CELLS TO EITHER
REACH MITOSIS OR EXIT THE CELL
CYCLE.
WE DID LIVE-CELL IMAGING
EXPERIMENTS WHERE WE MEASURED
CDK2 ACTIVITY AND MEASURED THE
TIME IT TAKES CELLS TO GO FROM S
PHASE TO REACH THE NEXT MITOSIS.
YOU CAN SEE THAT THE MITOSIS
WHEN YOU SEE THE RAPID DROP IN
CDK2 ACTIVITY WE COVERED WITH A
BLACK DOT.
WE FOUND ON AVERAGE IT TAKES
CELLS ABOUT 12 HOURS TO REACH
MITOSIS.
AND THEN WE TREATED CELLS WITH
THE CDK4/6 INHIBITOR AND ASKED
HOW LONG DOES IT TAKE THESE PINK
CELLS TO LOSE CDK2 ACTIVITY AND
EXIT THE CELL CYCLE.
THE TIME OVERLAPPED WITH THE
TIME IT TOOK THE OTHER CELLS TO
REACH MITOSIS.
WE THOUGHT ABOUT THIS PROBLEM
AND REALIZED THAT THESE TWO
FATES WE OBSERVED ARE MUTUALLY
EXCLUSIVE.
IF YOU EXIT THE CELL CYCLE THEN
YOU CAN'T BY DEFINITION GO
THROUGH MITOSIS AND VICE VERSA.
BECAUSE THESE TWO FATES ARE
HAPPENING ON VERY SIMILAR TIME
SCALES, THEY ARE IN COMPETITION
WITH EACH OTHER.
SO WE HYPOTHESIZED THAT PERHAPS
IF WE WERE ABLE TO BLOCK THE
CELLS FROM UNDERGOING MITOSIS,
MAYBE WE WOULD OBSERVE ALL CELLS
EXISTING INTO THIS STATE AND NOT
JUST THESE FEW OUTLIER CELLS.
SO TO BLOCK MITOSIS, WE TREATED
WITH A CDK1 INHIBITOR AND
COMBINED WITH THE CDK4/6
INHIBITOR AND NOW ALL CELLS CAN
EXPECT THE CELL CYCLE INTO THIS
G0-LIKE STATE AND TAKE THIS
ALTERNATE PATH.
IT'S NOT THAT THERE WAS
SOMETHING BIOCHEMICAL OR
GENETICALLY DIFFERENT ABOUT
THESE FEW OUTLIER CELLS, THE
RELATIVE TIMING BETWEEN EITHER
EXITING THE CELL CYCLE OR
MITOSIS THAT DICTATES THE FATE
OF THESE CELLS.
MECHANISTICALLY, THE REASON WHY
THIS ALL IMPORTANT FEEDBACK LOOP
IS REVERSIBLE IS BECAUSE WE
FOUND THAT CYCLIN A mRNA IS
THE UNIQUELY REGULATED BY CDK4/6
IN THE ENTIRE CELL CYCLE.
IF YOU TREAT CELLS WITH THE
CDK4/6 INHIBITOR AND MEASURE
COMPONENTS, CYCLIN A mRNA WAS
LOST UPON TREATMENT WITH THE
DRUG.
WHILE THE REST OF THE COMPONENTS
APPEARED TO BE SUSTAINED FOR
MANY HOURS.
WE FOUND THAT THIS IS BECAUSE OF
A NEW SIGNALING COMPONENT TO
THIS PATHWAY.
CDK4/6 REGULATES CYCLIN A mRNA
THROUGH TWO RB-LIKE PROTEINS AND
A FAMILY OF REPRESS TORY E2Fs.
AND THIS MEANS THAT WHEN YOU
TREAT CELLS WITH THE CDK4/6
INHIBITOR ICYCLIN A mRNA IS
RAPIDLY LOST AND THESE PROTEINS
CAN BE MAINTAINED AS LONG AS
THOSE PROTEINS ARE AROUND
BECAUSE THEY CAN BE STABLE.
AND THAT MEANS THAT CDK2 WILL
STAY ACTIVE AS LONG AS THERE IS
CYCLIN A PROTEIN AROUND.
WE WERE ABLE TO SUPPORT THIS BY
SHOWING A STRONG CORRELATION
BETWEEN THE HALF-LIFE OF CYCLIN
A PROTEIN ACROSS DIFFERENT CELL
LINES AND THE TIME IT TAKES
CELLS TO EXIT THE CELL CYCLE.
WE CAN MANIPULATE THIS BY FUSING
CYCLIN A TO IN -- DESTABILIZE
IT.
NOW CELLS EXIT THE CELL CYCLE
FASTER UPON TREATMENT WITH THE
CDK4/6 INHIBITOR.
SO THAT MEANS THAT INSTEAD OF
THIS RESTRICTION POINT
PHENOMENON BEING REGULATED BY
SELF SUSTAINING FEEDBACK LOOK,
WHAT WE HAVE SHOWN IS THAT THE
RESTRICTION POINT PHENOMENON IS
EXPLAINED BY TEMPORAL
COMPETITION BETWEEN THESE TWO
MUTUALLY EXCLUSIVE FATES OF
MITOSIS OR CELL CYCLE EXIT.
THAT'S BECAUSE CDK4/6 AND
UPSTREAM SIGNALING IS NEEDED FOR
THE ENTIRE CELL CYCLE.
AND THE IMPLICATIONS OF THIS ARE
THAT INHIBITING CDK ACTIVITY CAN
SEND CELLS TO THIS G0-LIKE
STAYED WHERE THEY HAVE AN EXTRA
COPY OF DNA.
WE THINK THAT THIS STUDY REALLY
ANSWERS A LONG-STANDING
DECADES-OLD PROBLEM OF THE
RESTRICTION POINT PHENOMENON BUT
I THINK THESE FINDINGS GO BEYOND
JUST OUR BASIC UNDERSTANDING OF
CELL BIOLOGY.
GIVEN THE CLINICAL USE OF CDK
INHIBITORS IN THE CLINICAL
TRIALS, WE THINK THAT THIS STUDY
HAS BROAD IMPLICATIONS.
THAT'S WHAT WE ARE TAKING THIS
NOW IN THE FUTURE.
WE ARE STARTING TO UNDERSTAND
HOW THESE -- HOW NEW MECHANISM
MIGHT BE WORKING IN ALL ANIMALS
AND IN THE CLINIC.
SO FOR EXAMPLE, CDK4/6
INHIBITORS ARE USED IN THE
CLINIC BECAUSE THEY ARE THE
FRONT-LINE THERAPY FOR HORMONE
RECEPTIVE POSITIVE BREAST CANCER
AND CLINICAL TRIALS FOR OTHER
CANCER TYPES, OF.
IN ADDITION CDK TWO INHIBITORS
ARE IN DEVELOPMENT BY A NUMBER
OF PHARMACEUTICAL COMPANIES TO
BEIDES ALONE OR IN COMBINATION
WITH CDK4/6 INHIBITORS.
BECAUSE WE HAVE SHOWN DRUGS CAN
INDUCE THIS PATH, IT'S CRITICAL
TO UNDERSTAND WHAT THE LONG-TERM
CONSEQUENCES OF CELLS IN THIS
STATE ARE.
FOR EXAMPLE, WHAT HAPPENS WHEN
YOU PUTTER THESE CELLS IN DRUG
HOLIDAYS?
YOU STOP GIVING THEM THE DRUGS.
WILL THEISMS RE.
THE CELL CYCLE?
IF THEY DO, WHAT PATH WILL THEY
TAKE?
WILL THEISMS THAT EXITED FROM G2
REMEMBER THAT'S WHERE THEY USED
TO BE IN THE CELL CYCLE AND
REENTER THE CELL CYCLE FROM G2
PHASE?
OR WILL THESE CELLS THINK THEY
ARE REALLY A G0 CELL AND REENTER
THE CELL CYCLE IN G1 PHASE?
WE ARE DOING PRELIMINARY STUDIES
WITH THIS BY TREATING WITH CDK
INHIBITORS AND WASHING THEM OFF.
OUR PRELIMINARY RESULTS GIVE US
A QUITE CLEAR ANSWER TO THIS
QUESTION.
WHEN YOU TREAT WITH THE DRUGS
THEY GO INTO A G0-LIKE STATE.
WHEN YOU WASH THEM OFF, THE
CELLS REENTER THE CELL CYCLE IN
G1 PHASE AND THEY'LL GO THROUGH
ANOTHER ROUND OF DNA SYNTHESIS
AND THEY END UP WITH 8 END DNA
CONTENT, THEY HAVE GONE THROUGH
A WHOLE GENOME DUPLICATION.
THEY WILL UNDERGO ANOTHER
MITOSIS AND IF WE WATCH THEM,
THEY'LL DIVIDE INTO FOUR
DAUGHTER CELLS.
AND IF WE GROW THEISMS FOR LONG
PERIOD OF TIME, WE SEE A
TREATMENT PLUS WASHING OFF THE
DRUGS INDUCES A HUGE VARIETY OF
DIFFERENT TYPES OF ANEUPLOIDY
WHICH COULD HAVE DRASTIC
CONSEQUENCES FOR THE CANCER
CELLS BEING TREATED AND
POTENTIALLY FOR NORMAL
PROLIFERATIVE CELLS AND
DIFFERENT TISSUES IN THE BODY.
SO OUR FUTURE STUDIES WILL BE TO
INVESTIGATE THIS FURTHER.
I THINK IT'S DEMONSTRATE HOW
REALLY A BASIC BIOLOGICAL
QUESTION CAN TRANSLATE AND HAVE
IMPORTANT CLINICAL IMPLICATIONS.
WITH THAT, I'D LIKE TO THANK MY
TEAM HERE AT THE NCI.
WE ARE RELATIVELY SMALL TEAM BUT
THROUGH HARD WORK AND DEDICATION
THEY HAVE BEEN PRODUCTIVE.
AND ALSO WE HAD A NUMBER OF
COLLABORATIONS BOTH WITHIN THE
NIH AND OUTSIDE OF THE NIH.
AND I THANK YOU FOR YOUR
ATTENTION AND I'M HAPPY TO TAKE
ANY QUESTIONS.
>> BEAUTIFUL WORK, STEPHEN.
I THINK YOU HAVE YOUR HAND UP.
>> I'M LOOKING FOR THE THE HAND.
THANK YOU.
STEPHEN, GREAT TALK.
I WONDER IF YOU COULD COMMENT ON
IMPLICATIONS FOR DEVELOPMENT OF
PAL BOW RESISTANCE?
IT SEEMS LIKE MAYBE THERE COULD
NOW BE ANOTHER PATHWAY IN
CHUCKED DEVELOP RESISTANT
MUTATIONS THAT'S NOT, RB RELATED
OR MYC RELATED.
BUT IT'S A G2 RELATED, SG2
RELATED PATHWAY --
>> FOR SURE.
THAT'S WHAT WE ARE THINKING
ABOUT NOW.
WITH THESE DRUG WASH OFF
EXPERIMENT.
BECAUSE IT INDUCES ANDYPLOYEDY.
YOU'RE SHUFFLING OFF THE GENES
OF THESE CELLS AND MAYBE THAT
COULD LEAD TO SOME SMALL
POPULATION WHERE EVEN MYC IS UP
REGULATED.
THAT COULD BE THE GENETIC
PERTBAITION THAT LEADS TO THESE
RESISTANCE MECHANISMS T.
>> KARIN?
>> I HAD A VERY SIMILAR QUESTION
BUT I ALSO WONDER IF YOU MIGHT E
BEAUTIFUL BUT A COLLABORATION
WHERE WE MIGHT BE ABLE TO
FURTHER UNDERSTAND HOW THESE
PATHWAYS ARE BEING TWEAKED IN
THE RESISTANCE MODELS THAT
ALREADY DEVELOPED, COULD BE
INTERESTING.
>> WE ARE TRYING TO REACH OUT TO
FIND CLINICAL SAMPLES OR LAB
THAT IS HAVE PATIENT DATA TO SEE
IF SOME OF THE STUFF THEY ARE
SEEISEEING IS MATCH WHAT WE ARE
SEEING AS WELL.
>> SO WHAT ARE THE IMPLICATIONS
TO MY TO THETIC CATASTROPHE AND
STANDARD CHEMO TREATMENT?
IS THIS A POTENTIAL MECHANISM OF
RESISTANCE FOR CHEMO?
ESPECIALLY DNA DAMAGING AGENTS?
>> WE PLAYED AROUND A LOT WITH
DNA DAMAGE AND THAT'S HOW THIS
PROJECT STARTED.
WE WERE INDUCING DNA DAMAGE AND
SEEN THIS EXACT SAME TRAJECTORY.
AND WE THOUGHT IT HAD SOMETHING
TO DO WITH DNA DAMAGE.
WE STARTED INVESTIGATING ALL
THESE PATHWAYS.
AND THEN WE REALIZED THAT WHAT
DNA DAMAGE WAS DOING WAS
TRIGGERING THE G2M CHECKPOINT
AND IT WAS DELAYING THE TIME TO
REACH MITOSIS.
AND THAT'S WHEN WE STARTED
SAYING, IF THAT'S THE CASE, THEN
WE SHOULD BE ABLE TO REPEAT THE
PHENOTYPE WITH THE CDK1
INHIBITOR WHEN WE COMBINED WITH THE CDK4/6 INHIBITOR.
COMBINING DNA DAMAGE AND THE CDK4/6 INHIBITOR COULD BE
INDUCING THIS ALTERNATE TRAJECTORY THROUGH THE CELL
CYCLE QUITE A BIT.
THERE IS SOME INTERESTING
FINDINGS IN OUR SINGLE-CELL
WHOLE GENOME OVARIAN CANCER WORK
THAT TIES INTO THIS.
I CAN'T WAIT TO SEE THIS COME
OUT IN THE LITERATURE.
GOOD WORK.
ANY ADDITIONAL QUESTIONS FOR
STEPHEN BEFORE WE BREAK?
IF NOT, WELL, THANK YOU VERY
MUCH.
CONGRATULATIONS, BEAUTIFUL WORK
AND AGAIN WE LOOK FORWARD TO
SEEING ADVANCES IN THIS AREA.
THANKS.
OKAY, SO, WE MADE UP A COUPLE OF
MINUTES HERE.
SO WE'LL NOW TAKE A BREAK.
DO NOT DISCONNECT.
CLOSE YOUR VIDEOS AND MUTE YOUR
MICS IF YOU WOULD LIKE.
THE FOLKS IN THE VIRTUAL TABLE,
DOUG, DEAN AND JIM AND THE BOARD
MEMBERS, TAKE AN EIGHT MINUTE
BREAK AND RETURN IN 10 MINUTES
AFTER THE HOUR.
TURN YOUR VIDEO CAMERAS BACK ON.
ALL OTHERS SHOULD RETURNED AT
ROUGHLY 20 MINUTES AFTER SO WE
CAN -- SO THAT KEITH CAN BEGIN
PROMPTLY AT 25 AFTER THE HOUR.
SO VIRTUAL TABLE, DOUG, DEANA
AND JIM AND THE BOARD MEMBERS
TAKE ABOUT A 7-MINUTE BREAK AND
RETURN AT 10 MINUTES AFTER THE HOUR.
>> I'LL BE ASKING YOU TO RAISE
YOUR HAND OR STRAIGHT YOUR NAME
TO INDICATE DISAPPROVAL OR NON
CONCURRENCE SO PAULET CAN COUNT
AND RECORD THE VOTE.
WE HAVE A NEW RFP.
DR. DAN WILL BE THE PRESENTER.
THIS SUBCOMMITTEE IS CHAIRED BY
NELSON AND SUPPORTED BY NELLY
AND RICH ZELLER.
SO WITH THAT, DR. ZI, TAKE IT
AWAY.
>> THANK YOU FOR THE OPPORTUNITY
TO PRESENT THIS NEW DON
SEPTEMBER.
MICROBIOME TARGETED INTERVENTION
TO CANCER NETWORK.
ON BEHALF OF THE WORKING GROUP.
THIS CONCEPT IS SPONSORED BY THE
DCTD.
NEXT SLIDE.
THE RESEARCH AND HUMAN STUDIES
SHOW THE MICROBIOME CAN MODULATE
THE CANCER CELL.
SO THIS CONCEPT WILL BE FOCUSING
ON THE CLINICAL RESEARCH OF THE
FECAL MICROBIOTA WITH
IMMUNOTHERAPY.
THE HIGHLIGHT OF THE CHALLENGES,
PHASE I AND PHASE II CLINICAL
TRIAL UNDERWAY IN THE U.S. AND
INTERNATIONALLY WITH THE VARIOUS
DESIGN.
BUT LACK OF THE COORDINATION.
FOR THE FMT, LONG TERM SAFETY
AND THE PATIENT STRATIFICATION.
FOR THE MICROBIAL CONSORTIUM,
FOR SELECTIONS, BENEFICIAL
BACTERIA SPECIES CULMINATE WITH
THERAPEUTIC OUTCOME DIFFERENT
AMONG THE LABS AND COHORTS.
THE OPPORTUNITIES AND CLINICAL
AND PILOT FMT TILES SHOWED THE
RESULT OF THE SAFETY AND
IMPROVED IMMUNOTHERAPY RESPONSE
AND TOXICITY.
CLINICAL TRIAL NEED TO BUILD
FECAL MICROBIOME FOR THERAPY AND
THE REGISTRY IS LONG TERM SAFETY
NEEDED FOR THE RESEARCH FOR
VARIABLES.
NEXT SLIDE.
SO THESE ARE THE ONLY CANCER
THERAPEUTIC CLINICAL TRIALS.
THEY PUBLISHED ENCOURAGING
RESULT IN THE 2021 OF THE FIRST
IN-HUMAN PILOT TRIAL TO IMPROVE
RESPONSE.
SO THE GAP AND THE NEED.
THE LACK OF THE CLINICAL TRIAL,
THE ASSAY AND MICROBIOME'S
MEASUREMENT AND DATA ANALYSIS.
AND THE MOST CORRELATIVE
ANALYSIS T TESTING IN THE MICE
AND FMT.
THE LIMITATION OF THE
PRE-CLINICAL MODELS AND CLINICAL
CENTER.
FOR THE NCI, NEEDS TO STIMULATE,
COORDINATE THE CLINICAL TESTING
OF CAUSAL EFFECT OF MICROBIOME
ON CANCER THERAPY AND STUDYING
RELEVANT MECHANISMS.
ENSURE PROPER DIVERSITY IN THE
HUMAN MICROBIOME RESEARCH.
COORDINATE THE STANDARDIZATION
AND STUDY VARIABLES.
NEXT SLIDE.
THE PURCHASE OF THIS RFA AND
RFP -- PURPOSE -- TO TIMELY
EARLY STAGE CLINICAL TESTING OF
MICROBIOME TARGET CANCER
INTERVENTION TO IMPROVE
IMMUNOTHERAPY IN MICROBIOME
INTERVENTION CANCER NETWORK AND
THE CLINICAL CENTER AND CLINICAL
NETWORK CENTER.
SO OVERALL GOALS.
U19 TO DEVELOP OPTIMAL FMT OR
DEFINE MICROBIAL CONSORTIA FOR
EARLY PHASE OF CLINICAL TRIAL OF
SAFETY AND EFFICACY TO OVERCOME
IMMUNOTHERAPY RESISTANCES AND
REDUCE ADVERSE EVENTS.
CONDUCT BIDIRECTIONAL HUMAN
RELEVANT MECHANISTIC STUDIES.
N01, SUPPORT TWO CORES.
ADMINISTRATION CORE COORDINATE
ACROSS THE CENTERS AND ALSO THE
MICROBIOME CORE, HARMONIZE AND
STANDARDIZE THE FMT AND DEFINE
THE MICROBIAL CONSORTIA AND
CLINICAL TRIAL.
AND ALSO COORDINATE AND
STANDARDIZE THE BIOINFORMATIC
AND DATA FOR INFRASTRUCTURE AND
ESTABLISH ONE HUMAN CANCER
IMMUNOTHERAPY IN MICROBIOTA
ATLAS AND FMT REGISTRY.
AND ALSO TO DEVELOP ONE FECAL
RESOURCE TO THE COMMUNITY.
THE PRIORITY OF INTERVENTION IS
FMT OR DEFINE MICROBIAL
CONASSERTIA WITH IMMUNE
CHECKPOINT INHIBITOR OF THE CART
T THERAPIES.
NEXT SLIDE.
SO THIS SLIDE OUTLINES STRUCTURE
OF NETWORK.
HUMAN STUDY AND AT LEAST TWO
WILL DO THE CLINICAL TRIAL.
SO U19 NEEDS COPERCEIVE PI.
ONE FOR PRE-CLINICAL AND ONE FOR
CLINICAL.
NEXT SLIDE.
SO THE EXAMPLE OF THE PROJECT,
ALL U19s MUCH DEVELOP
INTERVENTION AND OBTAIN R&D AND
ALL CONDUCT CLINICAL TRIAL.
AND MICROBIAL COMPOSITION AND
FUNCTIONS THROUGH MULTI-OAKICS,
MEASURE BIOMARKERS AND SHOW WITH
THERAPY OUTCOMES AND INVESTIGATE
THE VARIABLES.
PRE AND PROBIOTIC PROJECT IS
ENCOURAGED AND HUMAN RELEVANT --
STUDIES.
SCIENTIFIC BASIS FOR THE HUMAN
CORE STUDY, WE ARE TO REQUIRE
TWO RACES AND REQUIRE TWO
LOCATIONS --
[ BACKGROUND NOISE ]
>> NEXT SLIDE, PLEASE.
SO JUSTIFICATION OF RFA AND RFP,
SCIENTIFIC NEEDS FOR OPTIMIZED
APPROACH OF CONCEPT OF CLINICAL
TRIAL.
AND ALSO MULTIDISCIPLINED TEAMS
TO THE COLLABORATIVE NETWORK
WITH A SINGLE RECIPIENT DATE AND
SPECIFIC REVIEW CRITERIA.
THE R IF.
P WOULD BETTER SERVE THE NETWORK
AND COMMUNITY IN THE LONG RUN.
FOR THE U MECHANISM, THE NETWORK
AND SYNERGY.
THE NCI APPROVAL STAFF
INVOLVEMENT IN THE STEERING
COMMITTEE TIMELY PROVIDE
PROGRAMMATIC FOR THE INPUT AND
ALSO OTHER RESOURCES AND
INFORMATION.
THE COLLABORATION CAN BE FURTHER
ESTABLISHED FOR THE POST AWARD.
NEXT SLIDE, PLEASE.
THE BUDGET IS 7.5 TOTAL COST PER
YEAR AND 37.5 FURTHER COST FOR
FIVE YEARS.
NEXT SLIDE.
THE EVALUATION CRITERIA FOR THE
U19, TO CONDUCT CLINICAL TRIAL
OR DEVELOP THE INTERVENTION R&D.
PROCEDURE FOR CLINICAL TRIAL AND
INTERVENTIONS AND ALSO ADVANCE
THE SCIENTIFIC KNOWLEDGE OF THE
VARIABLES AND THE MECHANISMS AND
ALSO TO TRANSFORM THE GUT
MICROBIOME AND IMPACT ON THE
IMMUNOTHERAPY.
THE RESULTS INFORM THE TRIAL AND
TEAM TO CONDUCT CLINICAL TRIAL.
AND ALSO TO IMPROVE THE HEALTH
DISPARITY IN THE CANCER
MICROBIOME RESEARCH.
FOR THE N01, THE CANCER
IMMUNOTHERAPY AND MICROBIOME
RESEARCH FOR THE COMMUNITY TO
ENSURE DATABASE AND FECAL
RESOURCE.
ALSO TO STANDARDIZE THE
MEASUREMENT AND ALSO ADVANCE THE
COMPUTATION BIOLOGY.
NEXT SLIDE IS THE LAST SLIDE.
I HAVE INCORPORATED ALL THE BSA
REVIEW COMMENTS ON THIS SLIDE.
THE REVIEWERS ARE --
[ READING ]
ALL THANK YOU FOR YOUR VALUABLE
SUGGESTIONS.
MOST ARE REALLY INCLUDED IN THE
SLIDES HERE.
I JUST WANT TO HAVE ADDITIONAL
MENTIONS HERE.
INCLUDING EPIDEMIOLOGIST ALSO
WOULD BE APPROPRIATE TO GIVE
EXPANSIVE CLINICAL TRIALS AND
PROVIDE MEASUREMENT FOR SRNA AND
OMICS UP TO CERTAIN AMOUNT, FOR
EXAMPLE 300 SAMPLES PER YEAR FOR
CLINICAL TRIALS U19 WITH NCI
PRE-APPROVAL.
THE PRO OMICS IS NOT REQUIRED
BUT NCI WORKING GROUP WILL MAKE
THE PLAN WITH INPUT FROM THE
STEERING COMMITTEE TO USE THAT.
IN TIME FOR THE DISPARITY AND
DIVERSITY REQUIREMENT ON
SCIENTIFIC BASIS WITH TRIAL WITH
MORE THAN ONE STATISTICAL
POWERED RACE WILL BE CONSIDERED
PRIORITY FOR FUNDING BUT NO
REQUIREMENT FOR MORE THAN ONE
SITE.
I STOP HERE.
OPEN WITH QUESTION AND LOOK FOR
YOUR INPUT.
THANK YOU.
>> THANK YOU VERY MUCH.
NELSON WOULD YOU LIKE TO GET US
STARTED IN DISCUSSION?
>> THANK YOU.
I THINK WE HAD A PRETTY ROBUST
DISCUSSION AROUND THIS.
I THINK THIS IS A PRETTY TIMELY
ISSUE.
I THINK THERE IS A LOT OF WORK
GOING ON IN THIS AREA AND I
THINK WHAT WAS SHOWED WITH JUST
TWO GRANTS, THE PORTFOLIO IS A
LITTLE LOW.
WE HAD A LOT OF DISCUSSION
AROUND HOW TO OPTIMIZE THIS AND
I THINK AT THE LAST SLIDE THAT
WAS SHOWN, I THINK A LOT OF OUR
COMMENTS WERE TAKEN INTO THE
PROPOSAL.
SO THE COMMITTEE WAS PRETTY
ENTHUSIASTIC ABOUT THIS WORK.
>> IT WAS EXPRESSED WELL.
THERE WAS A LOT OF DISCUSSION
ABOUT HOW TO MAKE A VERY COMPLEX
AND IMPORTANT PROPOSAL BECAUSE
THERE IS A LOT OF OPPORTUNITIES
TO DO IMPORTANT RESEARCH HERE.
SO THANK YOU FOR TAKING OUR
COMMENTS INTO CONSIDERATION.
>> I HAVE NOTHING MORE TO ADD TO
WHAT MY COLLEAGUES SAID.
MY ONLY MINOR, MINOR, MINOR
CONCERN WAS THAT THERE WAS SUCH
AN EMPHASIS ON DOING THE
CLINICAL TRIAL AND A LITTLE LESS
EMPHASIS ON PRE-CLINICAL WORK TO
GO ALONG WITH IT.
BUT I THINK DR. ZI ADDRESSED
SOME OF THAT.
>> OPEN FOR DISCUSSION.
TRENT.
>> THANK YOU, KEITH.
I'M WONDERING IF ANYONE WHO JUST
SPOKE CAN COMMENT ON THE
RELEVANCE.
IT SEEMS LIKE THERE MIGHT BE
SOME ON THIS CONTROVERSY THAT
HAS BEEN GOING ON OVER WHETHER
AND THE EXTENT TO WHICH THE
MICROBIOME IS A CANCER AT ALL
AND IF YOU HAVEN'T FOLLOWED
THIS, YOU CAN GOOGLE STEPHEN
STALLED BERG AND MICROBIOME AND
CANCER.
AND NOT GO DRAMA HERE BUT IT
SEEMS LIKE THAT -- IT'S TWO VERY
WELL RESPECTED GROUPS WHO SIMPLY
HAVE A SCIENTIFIC DISAGREEMENT
ABOUT ACCURACY OF WHETHER OR NOT
A COUPLE OF PROMINENT PAPERS
THAT CLAIM TO FIND MICROBIOME
ASSOCIATIONS IN TUMORS WEREN'T
ACTUALLY MISTAKENLY FINDING
HUMAN DNA THAT WERE MISLABELED
IN DATABASES.
IT'S AN ONGOING DISCUSSION.
MAYBE SOMEONE ELSE HAS MORE
CURRENT KNOWLEDGE THAN ME AS TO
WHETHER IT'S BEEN RESOLVED BUT
IT SEEMS IMPORTANT, AT LEAST TO
THE PARTS OF WHAT ARE BEING
DISCUSSED WITH THIS RFA.
>> I CAN RESPOND, BUT I'D LIKE A
BSA MEMBER.
>> I JUST WANT TO RAISE IT.
I MEAN --
>> OKAY.
I CAN SAY A COUPLE OF THINGS.
ONE THING IS IN THE CONCEPT WE
DO MENTION WHENEVER THE TISSUE
IS AVAILABLE WE ALSO ENCOURAGE
TO DO THE MICROBIOME MEASUREMENT
WITH THE TISSUE.
SO -- I THINK I READ THAT PAPER
AND A LOT OF WHAT YOU
DISCUSSED -- I THINK FURTHERMORE
MAINLY A TERM FOR AI, THE
COMPUTATION FOR THE METHOD.
SO ACTUALLY THE FIELD IN THE
MICROBIOME HOW TO DO THE
COMPUTATION, CORRECTION, IS NOT
VERY STANDARDIZED.
SO THIS IS LARGE AREA WE ALSO
CAN INCLUDE.
I ALSO MENTIONED ON THE SLIDE
AND IF YOU NOTICE FOR THE
EXAMPLE, THE AI IS ENCOURAGED.
SO AI RIGHT NOW STILL IS NOT
STANDARDIZATION -- BEST
CORRECTION SO THAT IS
COMPUTATION.
>> MY IMPRESSION WAS IT WAS MORE
THAN THE COMPUTATION.
IT WAS REALLY ABOUT ANNOTATION
OF SEQUENCES IN DATABASES.
YES, THERE IS SOME, OF COURSE,
SEQUENCE ALIGNMENT METHODOLOGY
BEHIND THAT.
I KNOW AI IS A POPULAR WORD
THESE DAYS BUT I DON'T THINK
THIS IS LIKE CHAT GBT LEVEL AI.
I THINK THIS IS A CLASSICAL --ED
IF THEY ARE RIGHT, IT'S A
CLASSICAL DATABASE ISSUE AND THE
DATABASE IS JUST MISS ANITATED.
AND AGAIN, IT'S TWO VERY
WELL-RESPECTED GROUPS.
THERE IS NO DISHONESTY GOING ON
HERE.
IT'S SIMPLY WHO IS RIGHT.
ANYWAY, SOMETHING TO BE AWARE
OF.
>> OKAY, THANK YOU VERY MUCH.
FOCUS ON WHETHER CONTAMINATION
OF THE HUMAN SEQUENCE --
>> IT'S A CONTAMINATION.
IT'S A COUPLE OF VERY LARGE
PAPERS THAT WOULD HAVE TO BE
RETRACTED THAT HAVE REALLY
DRIVEN THIS FIELD.
THAT'S THE REASON FOR THE RED
FLAG, I THINK.
>> KARIN AND THEN SHELLY.
>> THANKS.
A REALLY INTERESTING CONCEPT.
I MISSED IN YOUR LAST SLIDE --
SO THERE IS A BIG EMPHASIS ON
FMS AND INTERVENTION.
ON THE LAST SLIDE IN YOUR
RESPONSES YOU CLARIFIED THAT
PRETTY AND PROBIOTICS COULD ALSO
BE INTERVENTIONS.
DOES THAT INCLUDE DIETARY
INTERVENTIONS?
>> YES.
>> OKAY.
VERY INTERESTING, THANK YOU.
>> SHELLY?
>> I THINK THIS IS REALLY
IMPORTANT FOR THE REASON THAT
TRAY RAISED.
AND THERE MAY NOT BE ENOUGH
MONEY IN IT TO REALLY RESOLVE
THIS BUT FROM THE BEGINNING OF
THE THREE PAPERS IT ALL SHOWED
THIS REALLY INTERESTING EFFECT
BUT ALL HAD DIFFERENT BUGS
DEPENDING ON WHERE THEY ARE.
THIS IS NOW BECOME A COTTAGE
INDUSTRY.
YOU SEE THIS ADVERTISED.
I MEAN, THIS IS SOMETHING THAT
REALLY HAS GOTTEN INTO THE
PUBLIC'S EYE AND IT NEEDS TO GET
RESOLVED.
AND I THINK THAT THIS IS
PROBABLY A GOOD WAY TO START.
WHAT IS ABSOLUTELY CRUCIAL IS
THAT ALL OF THE DATA AND FRANKLY
BIOLOGIC SAMPLES THAT COME OUT
OF THIS BE SHAREABLE.
BECAUSE IT'S GOING TO NEED A
NUMBER OF PEOPLE, SEQUENCING AND
CRUNCHING NUMBERS.
SO IT REALLY SETS UP A
REPOSITORY WHERE A NUMBER OF
PEOPLE CAN LOOK AT THIS IN
DIFFERENT WAYS.
I THINK IT'S VERY WORTHWHILE IN
DOING SIMPLY BECAUSE IT IS A BIG
CONTROVERSY.
>> GOOD DISCUSSION.
I DON'T SEE ANY REMAINING HANDS.
>> I HAVE MY HAND UP.
>> YOU'RE ON THE BACK SCREEN.
FRED, I THINK --
>> IZ JUST RAISED MY HAND UP
NOW.
I THINK ANDY'S HAND HAS BEEN UP
FOR QUITE A WHILE.
I WILL LET ANDY GO.
>> THANKS.
I THINK THIS IS VERY INTERESTING
AND I AGREE WITH WHAT SHELLY
SAID.
I THINK PART OF THE REASON TO
REALLY SUPPORT THIS IS TO KIND
OF RESOLVE SOME OF THESE
QUESTIONS IN THE FIELD WITH
TRIAL DATA.
I THINK ONE OF THE QUESTIONS I
WAS WONDERING ABOUT IS THE
REQUIREMENT ABOUT THE FDA
APPROVAL.
SPECIFICALLY WITH FMT, I THINK
THERE IS A HISTORY OF THE FDA
HAVING SHIFTING STANDARDS IN
TERMS OF HOW THEY HAVE PROVED
FMT AND HOW THEY CONSIDER FMT AS
A THERAPY.
I CAN IMAGINE A LOT OF PROPOSALS
MIGHT GET HUNG UP WITH THAT
REQUIREMENT.
IS THERE ANY EFFORT TO
COORDINATE WITH FDA WHEN THESE
PROPOSALS GET EVENTUALLY
SUPPORTED?
>> VERY GOOD QUESTION.
ACTUALLY, NCI LEAD THE
CONFERENCE OF WORKSHOP 2019
RIGHT AFTER I SEE THE PAPER
PUBLISHED IN 2018.
SO ALSO -- TO INCLUDE FDA.
THEY ARE PART OF THE PLAN.
AND OF THE MEETINGS AND
PUBLISHING THE WEBSITE.
THEY ARE HIGHLY SUPPORTIVE.
BEFORE WE SEE THE POSITIVE
RESULTS IN THE -- [ INAUDIBLE ]
SO WE HAVE COMMUNICATION
CONSTANTLY.
>> THANKS.
REALLY GREAT PROPOSAL AND VERY
MUCH APPRECIATE THE PERSPECTIVE
OF BRINGING IN THESE MULTIPLE
ASPECTS OF DIVERSITY.
AND ALSO OBVIOUSLY THE
MICROBIOME IS SO DEPENDENT ON
WHAT WE EAT.
AND I KNOW THAT THERE IS A LOT
TO LOOK AT BUT TO JUST BE SURE
AS I THINK SOME FOLKS WERE
ALLUDING TO THAT ACCESS TO FOOD,
GEOGRAPHIC LOCATION, PROCESSING
OF FOOD CAN DIFFER AS WE AGE.
AND SO ALL OF THOSE COMPONENTS
MAY ALSO BE IMPORTANT TO ENHANCE
OUR UNDERSTANDING.
THANK YOU.
>> YES, THANK YOU VERY MUCH.
>> THERE IS ISSUE OF DIFFERENCES
IN ANNOTATION AND I THINK THIS
IS REALLY AN IMPORTANT ISSUE
THAT WE CONTINUE TO PRODUCE
RESULTS, MICROBIOME RESULTS WITH
THESE DIFFERENT LINES AND HAVE
KNOWN AGREEMENT ON WHICH ONE IS
ACCURATE.
I DOUBT HOW USEFUL OR
TRANSLATABLE THE FINDINGS ARE
GOING TO BE.
SO, I DON'T KNOW WHETHER THE NCI
CAN TAKE LEADERSHIP ROLE AND
BRING THE EXPERTS TOGETHER TO
TRY TO RESOLVE THIS ISSUE OF
ANNOTATION, ESPECIALLY WHEN IT
COMES TO TISSUE-LEVEL MICROBIOME
WHERE THE BOOKS ARE GOING TO BE
DOMINATED BY HUMAN IMMUNE CELLS.
I HAVE A COLLEAGUE I COLLABORATE
WITH MICROBIOME PROJECTS THAT --
USING SECONDARY DATA FROM
ANOTHER LAB, WE HAVE TO REQUEST
THE ORIGINAL READS AND REALIGN
WITH THE PIPELINE THAT HE TRUSTS
TO TRY TO GET OUR OWN
ANNOTATION.
SO I THINK THIS IS REALLY
IMPORTANT TO TRY TO RESOLVE SO
WE CAN GET SOME LEVEL OF
HOMOGENEITY.
>> I THINK THIS IS VERY TIMELY,
AND CONFERENCE IN MARCH.
I PROBABLY CAN ALSO BRING TO
THIS GROUP TOGETHER AND ALSO
INVITE THEM TO BE PART OF THIS
CONFERENCE AND WORKSHOP.
>> JOELING ACROSS THREE PAGES OF
GRID VIEW, I DON'T SEE ANY MORE
HANDS.
I THINK WE CAN MOVE TO VOTING.
SO NELSON T SOUNDS LIKE THE
COMMITTEE WAS SUPPORTIVE OF THIS
PROPOSAL.
I WOULD YOU LIKE TO MAKE A
MOTION.
>> MOVE TO APPROVE.
WHAT'S THE MOTION?
>> THAT'S IT.
YOU GOT IT.
CAN I GET A SECOND?
>> SECOND.
>> THANK YOU.
ANY FURTHER DISCUSSION?
I'M LOOKING SPECIFICALLY FOR
VOLTS OF DISAPPROVAL BY RAISE OF
HANDS OR VERBALLY.
PAULET?
NO PRE RECORDED ABSTENTIONS BUT
ANY LAST-MINUTE ONES?
>> NO.
SO IT'S UNANIMOUS APPROVAL.
>> OKAY.
THANK YOU, ALL.
THE NEXT CONCEPT IS REISSUE RFP,
NCISBIR INNOVATIVE CONCEPT FOR
PROGRAM.
DR. BOASA WILL BE THE PRESENTER.
THE SUBCOMMITTEE REVIEWED THIS
RE-ISSUANCE AND RECOMMENDED
DISCUSSION OR PRESENTATION, I
SHOULD SAY.
RAY IS THE CHAIR OF THIS
COMMITTEE, JENNIFER, WHO I
BELIEVE IS UNABLE TO JOIN US
THIS AFTERNOON, WAS ALSO ON THE
COMMITTEE AND CHANDRA.
SO THE TWO OF YOU HOPEFULLY CAN
DRIVE THE DISCUSSION.
SO WITH THAT SAID, DR. BOASA
TAKE IT AWAY WITH THE
PRESENTATION.
>> THANK YOU.
I'M PROGRAM DIRECTOR AT SBIR
DEVELOPMENT CENTER.
I'M EXCITED TO GO OVER THE
CONCEPT AWARD AND OUR PROPOSED
RE-ISSUANCE OF THIS REQUEST FOR
PROPOSAL.
THE SBIR STANDS FOR SMALL
BUSINESS INNOVATION RESEARCH.
IT'S ONE OF THE LARGEST SOURCES
OF NON-DILUTED SEED FUNDING.
SO CONGRESSIONALLY MANDATED
PROGRAM SO IT DOESN'T TAP INTO
THE RPG.
SO WE HAVE GUARANTEED SET ASIDES
EACH FISCAL YEAR FOR FY2023.
WE HAD 1.3 BILLION AT NIH AND
OVER 200 MILLION AT NCI.
SO LARGE SIZEABLE PROGRAM THAT
SMALL BUSINESS CAN TAKE
ADVANTAGE OF.
SO THE CONCEPT AWARD WAS
DEVELOPED IN RESPONSE TO AN
EXTERNAL WORKING GROUP THAT WAS
CONVENED BY THE NCAB.
IT WAS TO EVALUATE THE SBIR
PROGRAM AS A LOCAL.
ONE OF THEIR TOP RECOMMENDATIONS
WAS TO DEVELOP A HIGH RISK,
HIGH-REWARD CONCEPT PROGRAM TO
HELP PROMOTE PARADIGM SHIFTING
INNOVATION.
SO WITH THIS, WE PILOTED THE
PROGRAM AS A 3-YEAR PROGRAM IN
2021.
AND THE BIG PICTURE GOAL IS TO
FIND HIGH RISK, HIGH-REWARD
PROJECTS AT AN EARLY STAGE.
A HIGH BAR ON INNOVATION AND THE
PEER-REVIEWED SCORING HAS BEEN
ADJUSTED WITH THE 50% WEIGHT
FOCUSED ON INNOVATION AND THE
SECOND COMPONENT IS WHERE
FOCUSING ON THIS SPECIFICALLY
FOR RARE AND PEDIATRIC CANCER
TECHNOLOGIES.
WE THINK THERE IS A NICE NATURAL
FIT WITH FEDERAL FUNDING AND
STIMULATION OF EARLY STAGE
INNOVATION AND SOME OF THESE LOW
POPULATION CANCER INDICATIONS
WHERE IT IS QUITE CHALLENGING
AND DIFFICULT FOR COMPANIES TO
COMMERCIALIZE TECHNOLOGIES IN
THE SPACE AND TRYING TO LOWER
THE BAR A BIT.
SO THE CONCEPT AWARDS IS 300,000
CONTRACT FUNDING OPPORTUNITY FOR
ONE YEAR PROJECTS.
THE OTHER BIG PIECE OF THIS IS
NO PRELIMINARY DATA IS REQUIRED
SO WE ARE AND HAVE BEEN
SUCCESSFUL IN FUNDING PROJECTS
THAT HAVE LIMITED AND IN SOME
CASES NO PRELIMINARY DATA.
THIS IS QUITE DIFFERENT FROM THE
REST OF OUR FUNDING
OPPORTUNITIES WITHIN THE SBIR
PROGRAM.
AND OUR GOAL IS TO GET THIS
FEDERAL FUNDING TO COMPANIES TO
PERFORM THE EXPERIMENTS AND TO
OBTAIN THIS INITIAL DERISKING.
I'LL USE THAT LANGUAGE A FEW
TIMES IN THE PRESENTATION.
THAT MEANS THE COMPANIES
GENERATING SOME OF THIS
FEASIBILITY PROOF-OF-CONCEPT
DATA THAT DERISKSING TECHNOLOGY
TOW MAKE IT MOREAL ATABLE FOR
FUTURE FUNDING CONSIDERATIONS
WHETHER THE PROGRAM OR OTHER
FEDERAL FUNDING OPPORTUNITIES OR
OUTSIDE OF FEDERAL FUNDING.
THE PROGRAM HAS BEEN A 3-PHASE
PROGRAM.
THESE ARE SBIR PHASES NOT
CLINICAL.
SINCE THAT, WE DEVELOPED A
CONCEPT AND WE VIEW IT AS
SITTING AT THE FOREFRONT OF OUR
PIPELINE.
SO IT ALLOWS US TO FUND HIGH
RISK, HIGH-REWARD PROJECTS AND
SERVES AS A PIPELINE OF UP
OVATION TO MAKE SURE OUR
PORTFOLIO KEEPS THESE EARLY
STAGE PROJECTS COMING IN.
SO THERE IS FOUR MAJOR PURPOSE
AND OBJECTIVES OF THE CONCEPT
AWARD I WANTED TO HIGHLIGHT FOR
YOU ALL.
THE FIRST IS PORTFOLIO
INNOVATION.
SO WE TOUCHED ON THIS AND
LOOKING TO FUND EARLY STAGE
HIGH-RISK, HIGH-REWARD PROJECTS
THAT HAVE THE POTENTIAL TO BE
TRANSFORMATIVE.
THE SECOND WE WANT TO UTILIZE
THIS MECHANISM TO ADDRESS
CURRENT PORTFOLIO GAPS WE HAVE
SPECIFICALLY FOR RARE AND
PEDIATRIC CANCERS AND BECAUSE
THESE ARE OFTEN QUITE
CHALLENGING TO COMMERCIALIZE WE
RECEIVE FEWER OF THESE
APPLICATIONS.
SO BY FOCUSING THROUGH THE
CONCEPT AWARD WE ARE HOPING TO
ADDRESS THESE PORTFOLIO GAPS.
THE THIRD IS, WE THINK IT IS
CRITICAL TO HAVE HIGH RESPONSE
RATES AND TAP INTO NEW
STAKEHOLDERS.
LOOKING FOR THE MOST INNOVATIVE
IDEAS, WE NEED TO SEE A LARGE
NUMBERS OF PROPOSALS TO SELECT
THE MOST INNOVATIVE PROJECTS AND
TAP INTO THE STAKEHOLDERS AT
THIS EARLY STAGE INNOVATION
STATION WHO HAVE BEEN RELUCTANT
TO APPLY BECAUSE OF LIMITED
PRELIMINARY DATA OR PREVIOUSLY
APPLIED BUT HAVE BEEN
UNSUCCESSFUL IN RECEIVING AN
AWARD.
AND THE LAST IS THIS PROJECT
DE-RISKING THIS TECHNOLOGY,
FINDING OUT IF WHATEVER IS BEING
PROPOSED WORKS OR NOT AND MOVING
IT FORWARD.
AND THE BIG PICTURE IMPACT IS WE
ARE TRYING TO ACCELERATE
OUT-OF-THE-BOX HIGH PATIENT
NEEDS FOR RARE AND PEDE 8 RICK
TECHNOLOGIES FROM CONCEPT TO
CLINIC.
HERE IS AN OVERVIEW OF OUR
AWARDS TO DATE.
THIS IS THROUGH TWO FUNDING
ROUTE, THE THIRD IS IN THE LAST
R IT WILL HAPPEN IN FEBRUARY OF
NEXT YEAR.
BUT THROUGH THE FIRST TWO ROUNDS
WE MADE 13 AWARDS TO DATE JUST
UNDER 4 MILLION IN NCI FUNDING.
THE NEXT METRIC WE DISCOVERED IS
38% OF AWARDS WERE MADE TO WOMEN
AND UNDERREPRESENTED MINORITIES
SO THAT MEANS THE SMALL BUSINESS
CONCERNS -- THESE DEMOGRAPHICS
AND THEIR LEADERSHIP POSITIONS.
AND IN TERMS OF PROJECT TYPES,
WE FUNDED A GOOD CHUNK OF
THERAPEUTICS AND ALSO SUCCESSFUL
IN FUNDING DIAGNOSTIC AND
LABORATORY TESTS.
IN TERMS OF INDICATIONS, WE ARE
FUNDING PEDIATRIC INDICATIONS
AND RARE INDICATIONS.
WE HAVE THINGS THAT ARE
ULTRARARE AND THINGS THAT ARE
LESS RAY RARE.
SO OUR DEFINITION IS BROAD
BECAUSE THE FOCUS IS ON
INNOVATION.
SO PANCREATIC CANCER IS LESS
RARE BUT STILL HAVE EXTREMELY
LOW SURVIVAL RATES, REALLY ARE
IN NEED OF IMPROVEMENTS OF
STANDARD OF CARE.
SO AN EXTERNAL EVALUATION
COMMITTEE WAS BROUGHT INTO
EVALUATE WHERE WE ARE WITH THE
CONCEPT AWARD PROGRAM.
IT'S CHAIRED BY DR. MEL
BILLINGSLY, PRESIDENT AND CEO OF
A LIFE SCIENCESES AND GREENHOUSE
IN PENNSYLVANIA.
HE CHAIRED THE ORIGINAL WORKING
GROUP WHO IS CONVENED AND
DEVELOPED THE IDEA FOR THE
CONCEPT AWARD.
WE THOUGHT IT WAS IMPORTANT TO
BRING HIM BACK FOR THIS
EVALUATION.
NEXT COUPLE SLIDES ARE SOME OF
THE KEY DATA WE PRESENTED TO THE
EXTERM WORKING GROUP AND WANTED
TO HIGHLIGHT FOR BSA.
THIS IS TO ILLUSTRATE WE ARE
DEFINITELY RECEIVING HIGH
RESPONSE RATES AND ARE TAPPING
INTO NEW STAKEHOLDERS.
SO THE CONCEPT AWARD UTILIZING A
WHITE PAPER PROCESS.
THE WHITE PAPER IS A SHORT 2-3
PAGE SUMMARY OF THE TECHNOLOGY
THAT OFFERS TO SUBMIT AND GET
QUICK FEEDBACK FROM NCI ON WHAT
IS BEING PROPOSED IS WITHIN
SCOPE OF THINGS WE WANT TO FUND
FOR THIS.
AND YOU CAN SEE FOR THE PAST
THREE FISCAL YEARS, WE RECEIVED
ANYWHERE BETWEEN 70-100 WHITE
PAPERS.
THIS LEADS TO A GOOD NUMBER OF
FULL PROPOSALS AND AWARDS THAT
ARE ABLE TO BE MADE.
THE OTHER COMPONENT IS 80% OF
WHITE PAPERS AND JUST UNDER 70%
OF AWARDS REPRESENT COMPANIES
NEW TO THESE FUNDS.
LIKELY THEY ARE INVOLVED IN THIS
EARLY SPACE AND THIS MECHANISM
THEY ARE ABLE TO GAIN ACCESS TO
THE PROGRAM.
THIS SLIDE TO TO ILLUSTRATE THE
AWARDS ADDRESS OUR PORTFOLIO
GAPS FOR RARE AND PEDIATRIC
CANCER.
THE TECHNOLOGY CLASS AND THEN
THE SPECIFIC INDICATION FOR EACH
AWARD AND THE FAR COLUMN ON THE
RIGHT INDICATES OUR VIEW POINTED
OF WHETHER THAT IS CURRENTLY
UNDER REPRESENTED IN OUR
PORTFOLIO.
SO THE CHECKMARK ILLUSTRATES
THAT AND EVEN FURTHER TO THE
RIGHT IT GIVES A NUMBER OF
AWARDS.
SO THESE ARE BASE PROJECTS AND
THIS INDICATES SPACE FOR OUR
FUNDING HISTORY.
IN SOME CASES, THESE INDICATIONS
ONLY HAVE ONE AWARD.
SO DEFINITELY ADDRESSING THESE
PORTFOLIO GAPS.
85% OF AWARDS WERE MADE ON THE
INDICATION SPACE.
IN TERMS OF PORTFOLIO
INNOVATION, WE ARE GETTING
REALLY INNOVATIVE PROJECTS,
NOVEL TECHNOLOGY CLASSES SUCH AS
NEXT GENERATION CAR T
TECHNOLOGIES.
FIRST-IN-CLASS THERAPEUTIC
TARGETS, NOVEL DRUG DELIVERY
METHODS.
DIAGNOSTIC AND DEVICES AS WELL.
IN TERMS OF PROJECT DE-RISKING,
WE HAVE ABOUT SIX COMPANIES THAT
ARE FULLY VALUABLE AT THIS STAGE
GIVEN ENOUGH TIME POST AWARD.
OF THESE SIX TWO HAVE BEEN
EXTREMELY SUCCESSFUL AND
SHOWCASING ONE HERE, A COMPANY
COORDINATION PHARMACEUTICALS.
SO THEY ARE DEVELOPING AN
ACTIVATABLE CANCER VACCINE FOR
TREATMENT OF ORAL CANCER.
AND THROUGH THE CONCEPT AWARD
THEY WERE GIVEN FUNDS TO
ESTABLISH THEIR FEASIBILITY.
THEY GENERATED A NUMBER OF
ROBUST IN-VIVO EFFICACY DATASETS
FOR RARE CANCER MODELS.
AND SINCE THEN THE COMPANY HAS
BEEN SUCCESSFUL, ABOUT 18 MONTHS
POST AWARD USING THEIR COMPANY
MONEY THEY COMPLETED THEIR IND
AND FILED WITH FDA.
AND SCHEDULED TO START
FIRST-IN-HUMAN STUDIES IN 2024.
THIS IS A GOOD EXAMPLES HOW THIS
CAN BE LEVERAGED TO DERISK
TECHNOLOGY AND ACCELERATE
TOWARDS THE NEXT INFLECTION
POINT.
THESE ARE SOME OF THE FINDINGS
FROM THE EXTERNAL EVALUATION
COMMITTEE AND COMMENTED THE
CONCEPT AWARD HAS SUCCESSFULLY
MET ALL ORIGINAL EVALUATION
METRICS PROPOSED AT THE INITIAL
DEVELOPMENT OF THE CONCEPT.
INDEED DISRUPTED INNOVATIVE
APPROACHES BEING DEVELOPED FOR
PEDIATRIC AND RARE CANCERS.
THERE ARE HIGH RESPONSE RATES
AND THAT WE TAPPED INTO A NEW
POOL OF SMALL BUSINESSES FOR NEW
SBIR FUNDING.
THEY ALSO COMMENTED ABOUT THERE
IS PROMISING INDICATORS OF
FOLLOW ON FUNDING TIEING INTO
THE PROJECT DE-RISKING WE HAVE
BEEN SPEAKING ABOUT.
AND THEY FELT THE WHITE PAPER
REVIEW WAS A KEY FEATURE OF THE
PROGRAM AND THE WHITE PAPER
PROCESS ITSELF IS A NICE WIN FOR
NIH.
EACH YEAR WE ARE ABLE TO RECRUIT
70 DIFFERENT WHITE PAPER
REVIEWERS INTERNAL TO NIH TO
REVIEW WHAT THE PAPERS AND SPAN
MULTIPLE INSTITUTES.
MANY FROM NCI AND FOLKS FROM
NCATS AND IGMS AND NINDS AND
THIS WHITE PAPER PROCESS HELPS
US TO TRIAGE AND SELECT THE
INNOVATIVE PROJECTS TO MOVE
FORWARD FOR FULL PROPOSAL
SUBMISSION AND HELPS US TO MEET
ONE OF OUR ORIGINAL CONCEPT
EVALUATION METRICS WHICH WAS TO
MAKE AWARDS RAPIDLY WITHIN SIX
MONTHS.
SO WE THINK IT IS CRITICAL IF
YOU HAVE AN INNOVATIVE IDEA BUT
MAYBE NOT MUCH PRELIMINARY
DATAUX YOU WANT THE REVIEW AND
AWARD PROCESS TO BE AS QUICK AS
POSSIBLE.
SO FOR NIH 6 MONTHS IT'S QUITE
FAST.
TWO MAIN RECOMMENDATIONS MADE BY
THE EVALUATION COMMITTEE.
FIRST, UNANIMOUSLY RECOMMENDED
THE PROGRAM CONTINUE AND TWO
POTENTIAL IMPROVEMENTS WERE TO
DEVELOP ADDITIONAL FEDERAL
FUNDING TO SUPPORT SOME OF
THESE.
AND THE SECOND IS TO DEVELOP A
PITCH DAY EVENT WHERE AGAIN TO
HELP COMMERCIAL TRANSLATION OF
THESE TECHNOLOGIES.
SO HAVING CONCEPT AWARDS PITCH
THEIR TECHNOLOGY TO DIFFERENT
INVESTORS, FOLKS FROM NONPROFIT
DISEASE FOUNDATIONS, ANYONE THAT
HAS THE ABILITY TO HELP
COMMERCIALIZATION AND
TRANSLATION.
SO BASED OFF OF THAT, HERE IS
OUR PROPOSED RE-ISSUANCE REQUEST
AND BUDGET RECOMMENDATIONS.
SO REQUESTING 5-YEAR APPROVAL.
WE THINK IT'S A GOOD IDEA TO
MAINTAIN THE CURRENT CONCEPT
AWARD SIZE AT 300,000 FOR PHASE
I.
NOW PROPOSING TO DEVELOP FOLLOW
ON FEES, NOTICES OF FUNDING
OPPORTUNITIES.
AND THIS CAN BE A PHASE II OR
FAST TRACK OF 3 MILLION TO 3.5
MILLION.
AND THE REASON FOR THIS IS, WE
THINK ONCE THESE HAVE
OUT-OF-THE-BOX IDEAS, THESE
PROJECTS ARE DERISKED, IT'S
CRITICAL TO CREATE A STREAMLINED
PHASE II FUNDING PATH WHERE THEY
CAN MOVE THESE TECHNOLOGIES
FORWARD TO THE NEXT INFLECTION
POINT.
ANOTHER NICE THING WITH THESE
PHASE IIs IS WE HAD A LOT OF
MEETINGS AND DISCUSSIONS WITH
ANNUALA H SO THEY ARE
INTERESTED -- ARPA-H.
AND WE DO HAVE PREVIOUS
COFUNDING HISTORY WITH ARPA-H
LAST YEAR AND WE COFUNDED 5.7
MILLION IN SBIR PROJECTS.
THIS IS MY LAST SLIDE.
I WANTED TO ILLUSTRATE THAT THE
RFP PROCESS IS DEFINITELY
CRITICAL FOR CONCEPT AWARD AND
ALLOWS US TO DEVELOP THE SPECIAL
REVIEW CRITERIA WITH THIS
ENHANCED SCORE ON INNOVATION AND
ALLOWS US TO GENERATE THIS PANEL
WITH REVIEWERS WITH EXPERTISE IN
EVALUATING EARLY STAGE
INNOVATION.
IT ALLOWS US TO DEVELOP A
STREAMLINED PROPOSAL PROCESS.
THE WHITE PAPER PROCESS AND ALSO
GENERATED A FILLABLE FULL
PROPOSAL TEMPLATE QUITE NEW AND
IT ALLOWS TO ENTER STREAMLINED
INFORMATION IN A SIMPLIFIED
MANNER AND ALLOWS FOR PEER
REVIEW AND IT ALLOWS US TO GET
THAT CONCEPT METRIC OF MAKING
AWARDS RAPIDLY WITHIN SIX
MONTHS.
SO I'LL STOP HERE.
THANK YOU AND I'M HAPPY TO
ANSWER ANY QUESTIONS.
>> THANK YOU.
WOULD YOU LIKE TO GET THE
CONVERSATION GOING?
>> THANKS.
WE HAD THE OPPORTUNITY TO
GET-TOGETHER A FEW WEEKS AGO.
I THINK DR. CHANDRA AND OTHERS,
WE HAD A PRETTY GOOD DISCUSSION.
ESSENTIALLY HE PRESENTED TO US
MOSTLY WHAT YOU HEARD.
WE ALL CAME AWAY VERY
ENTHUSIASTIC.
WE THOUGHT THIS WAS AN IMPORTANT
PROGRAM AND THAT THEY HAD
ACHIEVED EVERYTHING THEY SET OUT
AS THE OBJECTIVES AND THAT THE
RESPONSE HAD BEEN VERY ENCOUR
ENCOURAGING THERE WERE SOME
QUESTIONS ABOUT WHY IS PAN
COUNTRY ATTIC CANCER A RARE
CANCER?
BUT YOU HEARD THE ANSWER THAT
WAS GIVEN.
IT SEEMED QUITEERABLY.
AND THERE WERE SOME SUGGESTIONS
ABOUT -- QUITE REASONABLE --
RAISE CAN AWARENESS OF THIS
PROGRAM AMONG THE PEOPLE WHO ARE
LIKELY TO BE INTERESTED IN IT.
I THINK THERE WERE
RECOMMENDATIONS COME YOU ALREADY
HEARD.
SO HOWEVER ALL, WE FEEL LIKE
THIS IS A TH TH THIS IS A PROPAT
SHOULD MOVE FORWARD.
WE WERE UNANIMOUS ON THAT.
DR. ARI, DO YOU HAVE ANY
COMMENTS?
>> SURE.
I CAN DIME IN.
AND AGAIN -- CHIME IN.
I RECALL WHAT WAS JUST MENTIONED
AND DR. BOSSA, CONGRATULATIONS.
WE ENJOYED YOUR TALK THEN AND
NOW AS WELL.
AND THIS IS VERY IMPORTANT.
AND I SPEAK FROM PERSONAL
EXPERIENCE BECAUSE SOME OF THESE
OUT-OF-THE-BOX IDEAS, THERE IS A
VALLEY OF DEBT.
YOU DON'T HAVE ENOUGH DATA.
TO GET DATA YOU NEED FUNDING BUT
YOU DON'T HAVE FUNDING TO
GENERATE THAT DATA.
SO A GOOD NUMBER OF NEW
INVENTIONS START IN THAT VALLEY
OF DEBT.
I THINK THIS IS QUITE -- AND
THERE IS A FEW THINGS LIKE WE
DISCUSSED, ONE IS HOW TO
ADVERTISE.
AND THANK YOU FOR SHARING THAT
ONE-PAGE PAMPHLET OR BROCHURE.
BECAUSE IN ADDITION TO GO TO
ACR, WE COULD TAKE THAT TO ASCO,
SOCIETY OF ONCOLOGY, ASTRO AND
ALL THE OTHER CANCER SOCIETIES.
THEN ONE OR TWO OTHER COMMENTS,
IT IS IMPRESSIVE THAT THE
TURN-AROUND TIME REMAINS AT SIX
MONTHS AND TWO, AS A SURGEON, I
HAVE TO SAY THIS, WHILE DEVICES
ACCOUNT FOR ABOUT 15%, IT WOULD
BE NICE TO SEE MORE DEVICES
BEING INCLUDED IN THIS BECAUSE
IT CONSISTENTLY SEEMS TO BE THE
STEPCHILD OF FUNDING.
BUT OTHERWISE, I THINK IT'S A
GREAT CONCEPT THAT'S BEING GONE
ON.
WE WHOLEHEARTEDLY SUPPORT IT.
>> THANK YOU.
HOWARD AND THEN JULIE?
>> SURE.
I ALSO SUPPORT AND SHARE WITH
OTHERS.
BUT I'D LIKE TO ASK ABOUT THE
FOLLOW-UP AND YOUR EVALUATION
METRICS GOING FORWARD.
YOU MENTIONED GETTING INTO AN
IND BUT CAN THERE BE ANY KIND OF
HISTORY OF SUCCESSFUL SUSTAINED
COMMERCIAL ACCESS?
THERE IS A LOT OF FAILURES THAT
END IN IND OR PHASE I AND NEVER
GET A PARTNERSHIP GOING FORWARD.
BECAUSE I MEAN, I DO THINK THAT
THERE IS VALUE IN UNDERSTANDING
THAT PROCESS AND MAYBE FINDING
WAYS TO SUPPORT IT GOING
FORWARD.
SO THERE IS COMMERCIAL ACCESS.
AND ANOTHER METRIC FOR
EVALUATION WILL BE THE NUMBER OF
PATIENTS IN THE UNITED STATES
THAT GET TO EXPERIENCE THE FINAL
PLAN OR THE GOAL OF WHAT THE
PROGRAM AND THE PROTOCOL IS
ABOUT.
AND ANYWAY, JUST COMMENTS GOING
FORWARD AND MAYBE YOU COULD
COMMENT ON JUST PLANS GOING
FORWARD THAT WE MIGHT GET MORE
LARGER FEEDBACK AND LEARN FROM
AS THIS PROCEEDS.
>> THANK YOU.
ABSOLUTELY.
THOSE ARE METRICS THAT WE
UTILIZE TO EVALUATE THAT PROGRAM
AS A WHOLE.
OBVIOUSLY COMMERCIALIZATION IS
THE NUMBER 1 THICK WE WANT TO
SEE HAPPEN.
I THINK IT'S CRITICAL.
SO IT'S BEEN PILOTED SO FAR FOR
THREE YEARS EXTENDING IT FURTHER
FOR FIVE YEARS.
IT'S GOING TO GET US TO A POINT
WHERE WE CAN START TO SEE
WHETHER THESE METRICS ARE BEING
MET.
SO EARLY SIGNS ARE POSITIVE.
IND IS NOT -- A COUPLE OF YEARS
TO GO BEFORE YOU GET TO BLA OR
GET TO COMMERCIALIZATION.
BUT WE DO HAVE ONE OTHER
EXAMPLE.
IT'S A DEVICE COMPANY.
THEY HAVE COMMERCIAL SALES
ALREADY WHICH WAS QUITE
IMPRESSIVE.
THEY HAVE 7 MILLION IN DEVICE
SALES WITHIN THE 18 MONTHS
POST-AWARD PROCESS.
SO THAT IS SOMETHING THAT IS ON
OUR RADAR AND PLAN TOO CONTINUE
MONITORING.
>> I WANTED TO COMPLIMENT YOU.
I THINK THIS IS AN INCREDIBLE
EXAMPLE OF THE NCI'S AGILITY.
I WAS PART OF THE GROUP THAT
WROTE THE CONCEPT GOALS.
AND THAT CAME FROM AN NCAB
REVIEW FOR SBIR SPONSORED BY NED
SHARPLESS AND IT WAS THE --
JAFFEE WAS THE CHAIR OF THAT
GROUP.
I THINK THIS IS AN EXAMPLE OF A
FULL CIRCUIT OF THE SBIR PROGRAM
REVIEW AND THE OBJECTIVE WAS TO
BRING IN MORE DIVERSE
APPLICATIONS NOT ONLY FRESMALL
COMPANIES BUT ALSO TO AREAS THAT
WERE NOT COVERED THROUGH OTHER
GRANTING MECHANISMS AND TO
PROVIDE FAST TURN AROUND.
I WOULD LOVE TO APPLAUD YOU ON
SEEING THE RESULTS OF THESE
ACTIONS IN FULL CIRCLE IN LESS
THAN FIVE YEARS AND SEE THREE
YEARS OF RESULTS.
THAT IS EXTRAORDINARY.
AND I JUST THINK IT'S REALLY
IMPORTANT TO HIGHLIGHT THAT
AGILITY WITHIN THE NCI.
I CONTINUE TO BELIEVE THAT THE
SIX MONTH TURN AROUND AND THE
SPEED OF THAT QUALITY REVIEW IS
ESSENTIAL FOR SMALL BUSINESSES.
IT IS ONE OF THE REASONS WHY
PEOPLE HISTORICALLY HAVE NOT
APPLIED FOR SBIRs AND SO I
WOULD LOVE TO CONTINUE TO
ENCOURAGE THE NCI TO LEVERAGE
ITS ABILITY TO BE AGILE IN ORDER
TO MEET THOSE GAPS AND I WONDER
IF MORE CONCEPT AWARDS CAN
ENABLE THE NCI TO DO THAT AT
BROADER SCALE.
>> I REALLY APPRECIATE THOSE
WORDS.
THAT'S SOMETHING WE CONTINUALLY
FIGHT AND MAKE SURE BECAUSE IT
INVOLVES MULTIPLE OFFICE EFFORT
WITHIN NCI TO MAKE THAT HAPPEN.
IT'S SOMETHING THAT IS ON OUR
RADAR AND WE WORK HARD TO
ACHIEVE THOSE NUMBERS.
SO SOMETHING WE PLAN TO KEEP
DOING, FOR SURE.
>> GREAT JOB.
>> HI, AGAIN, I THINK THIS IS A
GREAT ECHOING JULIE'S COMMENTS.
WHAT I WONDERED, IF THERE MIGHT
BE OPPORTUNITY TO LIST AS AN
AREA OF INTEREST THE
ENVIRONMENT.
THAT'S AN AREA THAT I THINK WE
DO NOT -- THERE IS SO MUCH WE
COULD LEARN MORE ABOUT.
AND ITS IMPACT ON CANCER.
SO, AND COMPANIES MAY HAVE
INTEREST AND THAT MAY BE A WAY
TO ACCELERATE KNOWLEDGE IN THIS
AREA.
BUT I THINK THE ENVIRONMENT IS
SOMETHING THAT IS VERY UNDER
STUDIED.
SO IT MAY BE AN OPPORTUNITY.
THANK YOU.
>> THANK YOU DR. LOPEZ.
>> I JUST WANTED TO ECHO THE
COMMENTS THAT WE DO NEED TO GO
AFTER ANY OPPORTUNITY, INCLUDING
ANY STANDING ON THIS ONE, FOR
MORE FUNDING TO SUPPORT SURGICAL
INNOVATION.
>> ABSOLUTELY.
WE HAVE DONE SOME EFFORTS ON OUR
RADAR SO WE SEPARATED THE PEER
REVIEW TO HAVE ONE FOCUSED ON
THERAPEUTICS AND ANOTHER FOR
TECHNOLOGIES AND DEVICES,
DIAGNOSTICS, EVERYTHING NON
THERAPEUTICS TO MAKE SURE THAT
EVERYONE IS GETTING AN EQUAL AND
FAIR SHOT.
AND WE ALSO HAVE BEEN INCREASING
OUR OUTREACH AT CONFERENCES
OUTSIDE OF THE THERAPEUTIC SPACE
AND THAT IS TRANSLATING WELL.
I CAN'T SPEAK TOO MUCH BUT THE
CURRENT OOH AWARDS FOR FY24 SEEM
QUITE PROMISING FOR THE NON
THERAPEUTIC TECHNOLOGIES AS WE
WELL.
>> THANKS.
>> I SEE NOW FURTHER HANDS.
SO, I THINK WE'LL MOVE TO
VOTING.
SO IT SOUNDS LIKE FROM THE
SUBCOMMITTEE'S PRIOR
DELIBERATIONS THAT THEY CAME
INTO THE MEETING WITH ENTHUSIASM
FOR CONCURRENCE.
RAY WOULD YOU LIKE TO MAKE A
MOTION?
>> I MOVE WE VOTE IN FAVOR.
>> CAN I GET A SECOND?
>> SECOND.
>> THANK YOU.
ANY FURTHER DISCUSSION?
HEARING NONE, THE MOTION IS FOR
CONCURRENCE.
SEEKING ANY NEW VOTES OF NON
CONCURRENCE?
VERBALLY OR BY RAISING YOUR
HANDS.
>> UNANIMOUS CONCURRENCE.
>> THANK YOU.
>> THANK YOU ALL.
SO NOW THE FINAL CONCEPT IS ALSO
A REISSUE RFA.
SMALL BUSINESS TRANSITION GRANT
FOR EARLY-STAGE INVESTIGATORS.
THIS WAS REVIEWED BY
SUBCOMMITTEE AND CHAIRED BY EARL
ROBERTSON WHO UNFORTUNATELY
COULDN'T JOIN US TODAY BECAUSE
OF A PERSONAL MATTER.
HOWEVER, ARE WITH US TODAY AND
WE'LL ASK THEM TO LEAD THE
DISCUSSION WHEN WE GET TO THAT
POINT.
THEY ALSO RECOMMEND THE
PRESENTATION.
WITH THAT, PLEASE TAKE IT AWAY.
>> SO PRESENTING THE SMALL
BUSINESS TRANSITION GRANT
RENEWAL INITIALLY LAUNCHED IN
2021.
FOR THREE-YEAR PILOT PHASE.
SO I WILL HIGHLIGHT TWO THINGS.
SO SMALL BUSINESS PROGRAM COMES
IN TWO FLAVORS, SBI ARE AND TTR.
AND SOME OF THE KEY DIFFERENCES
ARE THAT WITH SBIR MECHANISM THE
PRINCIPLE INVESTIGATOR NEEDS TO
BE MAJORITY EMPLOYED AT THE
COMPANY AND WHILE IT DOES ALLOW
FOR COMPANIES TO PARTNER WITH
UNIVERSITIES, THAT IS NOT A
REQUIREMENT.
IN CONTRAST, STTR MECHANISM
ALLOWS FLEXIBILITY WHERE THE PI
IS EMPLOYED, MAYBE EITHER AT
UNIVERSITY OR BUSINESS.
BUT IT DOES REQUIRE THAT THE
BUSINESS PARTNERS WITH A
UNIVERSITY OR NONPROFIT RESEARCH
INSTITUTION.
SO THE GOAL OF THE STTR PROGRAM
IS TO HELP ASSIST THAT
TECHNOLOGY FROM ACADEMIA TO
INDUSTRY.
AND JUST ALSO REITERATE THAT
BOTH PROGRAMS USE A
CONGRESSIONAL SET ASIDE SO IT
DOESN'T IMPACT RPG FUNDING.
SO THE MOTIVATION FOR THE SMALL
BUSINESS TRANSITION GRANT CAME
FROM A WORKSHOP THAT WE HELD
WITH CANCER CENTER TECH TRANSFER
AND INNOVATION OFFICES.
ONE OF THE KEY FINDINGS WAS THAT
IN MANY CASES, POSTDOCS AND
OTHER EARLY CAREER SCIENTISTS
ARE KEY TO HELP SPIN OUT
UNIVERSITTI TEKNOLOGI BECAUSE
THEY OFTEN MOVE WITH THE
TECHNOLOGY TO A SMALL SUBS TO
HELP FURTHER THE
COMMERCIALIZATION.
-- SMALL BUSINESS.
IN MANY CASES EARLY CAREER
SCIENTISTS LACK BUSINESS
EXPERIENCE AND THIS IS ALSO
REFLECTED IN THE SUCCESS RATES
WHEN YOU COMPARE EARLY-STAGE
INVESTIGATORS WITH MORE
EXPERIENCED INVESTIGATORS.
THEY TEND TO HAVE A LOWER
SUCCESS RATE FOR SBIR FUNDING
MECHANISMS.
SO, WE DEVELOPED A PROGRAM TO
SEE HOW WE COULD BETTER ADDRESS
THIS NEED BY CREATING A GRANT
MECHANISM THAT FOCUSED ON
EARLY-STAGE INVESTIGATORS.
SO THE PROGRAM WE CAME UP WITH
REQUIRED MENTORING FROM BOTH THE
RESEARCH SIDE AS WELL AS
BUSINESS AND ENTREPRENEURIAL
SIDE.
AND ALSO PROVIDES
ENTREPRENEURIAL STRAINING IN THE
FORM OF THE ICORE PROGRAM THAT
COMPANIES NEED TO TAKE PART IN.
AND THROUGH THE FUNDING PROVIDES
THEM WITH THE RESOURCES TO SPIN
OUT THE TECHNOLOGY AND WE ALSO
DEVELOPED A MECHANISM THAT
ALLOWS THEM TO USE STTR IN THE
FIRST YEAR SO THEY HAVE THE
FLEXIBILITY TO REMAIN AT THE
UNIVERSITY WHILE THE PROJECT AND
COMPANY GETS UP AND RUNNING.
SO THIS SLIDE SHOWS AN SO FAR
VIEW OF THE PROGRAM.
SBIR PROGRAM.
-- OVERVIEW.
GRANTS COME FIRST AS A PHASE I,
WHICH PROVIDES FUNDING FOR
PROOF-OF-CONCEPT WORK.
AND THEN FOLLOWING THAT, PHASE
II FUNDING IS FOR FURTHER
RESEARCH AND DEVELOPMENT.
THE SBTT PROGRAM USES A FAST
TRACK MECHANISM WHERE THE
APPLICANTS APPLY AT THE SAME
TIME FOR BOTH PHASE I AND PHASE
II FUNDING AND THEN IF THEY ARE
SUCCESSFUL, THEY WILL RECEIVE
PHASE I AWARD AND THEN ON
MEETING THE MILESTONES,
TRANSITION TO THE PHASE II
PROJECT WITHOUT HAVING TO GO
THROUGH REVIEW AGAIN.
SO IT'S A MECHANISM THAT ALLOWS
FOR MORE CONSISTENT LONG TERM
FUNDING OF A PROJECT, WHICH IS
REALLY IMPORTANT FOR HELPING
EARLY-STAGE INVESTIGATORS GET
THEIR TECHNOLOGY UP AND RUNNING.
SO THE ROOM IS MODELED ON THE
K99R00 PROGRAM WHICH IS DESIGNED
TO HELP RESEARCHERS GO DOWN THE
ACADEMIC INVESTIGATOR PATH.
SO IT'S DESIGNED TO HELP THE
INVESTIGATORS TAKE THE PATH OF
AN ENTREPRENEUR AND
COMMERCIALIZE THEIR
TECHNOLOGIES.
SO THE WAY IT WORKS, IT USES
FAST TRACK MECHANISM.
OTHER REQUIREMENTS ARE THE
DEFINITION OF EARLY STAGE
INVESTIGATOR IS THE PI IS WITHIN
10 YEARS OF THEIR PH.D. OR MD
DEGREE.
AND THAT THEY CAN PROVIDE TWO
MENTORS WHO ARE COMMITTED TO
THEIR PROJECT BOTH TECHNICAL AND
BUSINESSMEN TOR.
AND THE PILOT PROGRAM REQUIRED
THAT THEIR PIs ARE PERMANENT
RESIDENTS OR U.S. CITIZENS.
IN THE PHASE I COMPONENT, THE PI
TYPICALLY APOSTDOC WOULD LEAD
THE PROJECT AND THEY NEED TO
MEET THEIR COMMERCIAL -- PROJECT
MILESTONES IN ORDER TO
TRANSITION.
IN ADDITION TO THE RESEARCH
WORK, THEY NEED TO COMPLETE THE
NIH ICORE PROGRAM,
ENTREPRENEURIAL TRAINING PROGRAM
THAT I MENTIONED.
AND WE ALSO ALLOW FOR THE PHASE
I TO BE EXTENDED FOR THE SBTT
PROGRAM GIVEN THE EARLY-STAGE
INVESTIGATORS AND THEY NEED TO
TAKE PART IN THE ICORE.
WE ALLOW FOR THE PHASE I TO BE
ABLE TO TWO YEARS.
TYPICALLY PHASE I GRANTS ARE
JUST ONE YEAR.
FOLLOWING COMPLETION OF THE
PHASE I PROJECT, THEY NEED TO
TRANSITION FROM THE UNIVERSITY
TO THE BUSINESS IF THEY HAVE NOT
ALREADY DONE SO.
SO PHASE II NEEDS TO BE EMPLOYED
BY THE COMPANY, WHICH IS -- AND
THE PHASE II IS AN SBIR WHICH
ALLOWS US TO TAP INTO THE LARGER
SET ASIDE POOL.
THE PI CANNOT BE TRANSFERRED SO
THE GRANT FOLLOWS THE PI AND WE
DO ALLOW FOR SOME SMALL
BUSINESS -- SOME CHANGES IN
SCOPE WHERE NEEDED IF THEY ARE
JUSTIFIED BASED ON THE ICORE
RESEARCH AND PHASE I RESULTS.
SO THE PHASE I PROJECT BUDGET
AND THE CAP OF $400,000 AND THE
PHASE II OF TWO MILLION DOLLARS
OVER TWO YEARS.
WE FOUND ICORE PROGRAM TO BE A
REALLY GREAT PROGRAM IN HELPING
TO PROVIDE TRAINING.
THIS IS A SURVEY OF PARTICIPANTS
BEFORE AND AFTER.
SO YOU CAN SEE PRIOR TO STARTING
THE PROGRAM THEY HAD LACK OF
KNOWLEDGE IN SOME KEY
COMMERCIALIZATION KNOWLEDGE SUCH
AS REIMBURSEMENT AND REGULATORY
STRATEGY, PRE CLINICAL
DEVELOPMENT AND CLINICAL TRIALS.
AND ENTREPRENEUR TRAINING HELPED
TO ENHANCE AND ADDRESS THE
KNOWLEDGE GAPS.
THE PROGRAM WAS LAUNCHED IN 2021
AND IT HAD RELATIVELY STRONG
INTEREST.
A LOT OF INTEREST IN TERMS OF
POTENTIAL APPLICANTS.
WE RECEIVED BASED ON
CONVERSATIONS AND MEETINGS AT
CONFERENCES AND DISCUSSIONS WITH
ACADEMICS AND CANCER CENTERS AND
A LOT OF PUBLIC FEEDBACK FROM
BOTH ACADEMICS AT CANCER CENTERS
AND SMALL BUSINESSES.
LOOKING AT THE FIGURES, YOU CAN
SEE PRIOR TO THE SBTT PROGRAM WE
TYPICALLY RECEIVED ABOUT BETWEEN
30-40 PHASE II -- FAST TRACK
STTR APPLICATIONS PER YEAR.
AND ADDING THE PROGRAM HAS
HELPED BUMP UP THOSE NUMBERS
WITHOUT CANNIBALIZING THE
CURRENT LEVEL OF PHASE II
APPLICATIONS.
IN THE FIRST ROUND OF FUNDING
THERE WERE 15 PROPOSALS AND FOUR
AWARDS WERE MADE.
THE FOLLOWING YEAR 11
APPLICATIONS RECEIVED.
ONLY ONE WAS ABLE TO BE FUNDED
AT THE END.
AND THIS YEAR, THERE WERE 15
APPLICATIONS.
THOSE APPLICATIONS ARE STILL
UNDER REVIEW.
SO I'LLIVE TWO EXAMPLES OF
PROJECTS FROM THE FIRST COHORT.
THE FIRST IS TO A COMPANY CALLED
COVINA, THE PI WAS A POSTDOC IN
THE LAB OF ELLIOT AND THE
TECHNOLOGY WAS DEVELOPING A
SMALL MOLECULE INHIBITOR OF
HPV-16E6 ONCOPROTEIN.
THE GOAL OF BEING ABLE TO STOP
HPV INFECTIONS BEFORE CANCER
DEVELOPS AND TO TREAT
HPV-RELATED CANCERS AFTER
DETECTION.
THE PROJECT WAS SUCCESSFUL IN
PHASE I AND MOVED TO PHASE II.
AND IN THE SUMMER OF 20 -- OF
THIS YEAR.
AND THE PHASE II PROJECT WILL BE
FURTHER ENABLE STUDIES AND THE
COMPANY RECENTLY WAS ABLE TO
CLOSE A SEED ROUND AND IS
RAISING SERIES A FUNDING.
SECOND EXAMPLE IS A COMPANY
WHICH IS A SPIN OUT OF NATHAN'S
LAB FROM THE MEDICAL UNIVERSITY
OF SOUTH CAROLINA DEVELOPING A
CANCER VACCINE AND A MUTATED
FORM OF A PROTEIN FUSED TO AGR2,
NORMALLY ER-ASSOCIATED PROTEIN
BUT IS EXPRESSED ON THE CELL
SURFACE IN SOME TYPES OF CANCER.
THE PHASE I PROJECT WAS
SUCCESSFUL AND SHOWED IN-VIVO
EFFICACY OF THEIR MOUSE MODEL.
THE PROJECT TRANSITIONED TO
PHASE II THIS SUMMER AND PHASE
II PROJECT WILL DO FURTHER
EFFICACY STUDIES ON ALSO LOOK AT
COMBINATION WITH CHECKPOINT
INHIBITORS AND OTHER
IND-ENABLING STUDIES.
SO AS WITH THE AWARD, THIS
PROGRAM ALSO WAS EVALUATED WITH
EXTERNAL EVALUATION COMMITTEE
WITH MEMBERS FROM ACADEMIA,
INDUSTRY AND ALSO UNIVERSITY
TECH TRANSFER OFFICES.
THE COMMITTEE HAD STRONG
ENTHUSIASM FOR THE PROGRAM BUT
RECOMMENDED SOME CHANGES, WHICH
I'LL OUTLINE, PARTICULARLY
RELATED HOW TO BOOST APPLICATION
NUMBERS AND ELIGIBILITY.
ONE OF THE FIRST POINTS THAT
CAME UP WAS THAT BY RESTRICTING
APPLICANTS TO THE JUST PERMANENT
RESIDENTS AND CITIZENS, THAT
EXCLUDES A LOT OF THE
POSTDOCTORAL POPULATION WHICH
HAS A LOT OF FOREIGN TRAINEES.
SO THE PROPOSAL THAT WE ARE
RECOMMENDING IS TO EXPAND THE
ELIGIBILITY TO BE ALIGNED WITH
CURRENT SBIR AND STTR GRANTS
WHICH REQUIRED JUST THAT PI HAS
THE RIGHT TO WORK IN THE U.S.
AND THERE ARE MANY EXAMPLES OF
PIs THAT WANTED TO APPLY BUT
STILL WAITING FOR THAT GREEN
CARD AND THINGS LIKE THAT.
THIS WILL BE ONE WAY TO ADDRESS
THIS ISSUE.
ANOTHER CHALLENGE IDENTIFIED WAS
THAT A LOT OF INTERESTED
APPLICANTS HAD EXCITING
TECHNOLOGIES BUT PERHAPS WERE
NOT QUITE READY FOR A FAST TRACK
APPLICATION WHICH THE PILOT
REQUIRED.
SO THE RECOMMENDATION FROM THE
EVALUATION COMMITTEE WAS TO
ALLOW FOR ALSO JUST PHASE IN ADO
APPLICANTS TO THE GET THEIR FOOT
IN THE DOOR WITH A PHASE I
PROGRAM AND ALSO TAKE ADVANTAGE
OF OTHER NCISBIR RESOURCES SUCH
AS ADDITIONAL ACCESS TO
ENTREPRENEURS AND RESIDENTS TO
MENTORING PROGRAMS AND OTHER
NETWORKING PROGRAMS THAT WILL
HELP THEM FURTHER ADVANCE THEIR
STUDIES AND ALSO RAISE AWARENESS
OF POTENTIALLY FUNDRAISING.
AND THE THIRD RECOMMENDATION
WHICH ALSO WE DISCUSSED WITH THE
BSA EVALUATORS ON THE RFA WAS
HOW TO REACH OR IMPROVE OUTREACH
OF THE PROGRAM.
AND THINGS THAT WE WILL BE DOING
GOING FORWARD IS TO INCREASE OUR
OUTREACH TO PIs AT CONFERENCES
AND CANCER CENTERS AND
UNIVERSITIES, MEETINGS WITH
TRAINEES AND OTHER POSTDOC
GROUPS WHICH IS A RECOMMENDATION
FROM THE REVIEWERS.
TOW ALSO TARGET POTENTIAL
MENTORS WHO, THROUGH THINGS LIKE
THE TECH TRANSFER OFFICES AND
THE STRUCTURES AND INVESTORS AND
UTILIZE THE NETWORK OF THE STATE
ASSOCIATIONS AND OTHER INDUSTRY
GROUPS.
AND WE HAVE BEEN MAKING PROGRESS
IN THAT RECENTLY.
SO I WANT TO EMPHASIZE THAT THE
STTR PROGRAM IS REALLY JUST PART
OF OUR LARGER STRATEGY TO HELP
IMPROVE DIVERSITY AND ACCESS TO
THE SBIR FUNDING.
THE GOAL IS ABOUT HOW WE CAN
FOSTER AN ECOSYSTEM THAT
ENCOURAGES COMMERCIALIZATION AND
SO THIS IS PART OF OUR STRATEGY.
SOME OTHER THINGS WE ARE DOING
TO HELP BUILD THIS PIPELINE AND
IMPROVE THE ECOSYSTEM IS WORK
THAT WE HAVE UNDER DEVELOPMENT
SO WE RECENTLY RELEASED WITH THE
CANCER TRAINING A NOTICE OF
SPECIAL INTEREST TO DEVELOP
TRAINING PROGRAMS FOCUSED ON
ENTREPRENEURSHIP AND THE GOAL IS
TO HELP IMPROVE EDUCATION AND
UNDERSTANDING OF HOW TO
COMMERCIALIZE TECHNOLOGIES FOR
EARLY STAGE TRAINEES.
WE ALSO PARTNERING WITH THE
OFFICE TO DEVELOP A PROGRAM TO
TARGET ENTREPRENEURS PRIOR TO
HAVING AN SBIR GRANT AND THAT IS
SOMETHING WE THINK WILL REALLY
HELP IMPROVE AWARENESS AND THE
PIPELINE OF ENTREPRENEUR-MINDED
INVESTIGATORS.
WE ARE ALSO LOOKING AT WAYS TO
PROVIDE FURTHER APPLICATION
ASSISTANCE.
SO WE ARE LOOKING AT ENHANCING
THE APPLICATION ASSISTANCE
PROGRAM WHICH WE HAVE RUN OVER
THE LAST NUMBER OF YEARS AND
LOOKING TO ADD TO THAT
ASSISTANCE IN HELPING THE
APPLICANTS WORK AND DISCOVERY
IMPROVING GRANT WRITING AND
NAVIGATING THE POST AWARD
PROCESS SUCH AS RESUBMISSION AND
THE INTRODUCTION PAGE.
AND ALSO LOOKING AT WAYS WE CAN
HELP INVESTIGATORS THINK ABOUT
CREATION AND IP EVALUATION, A
LOT OF THE OTHERY STEPS THAT GO
INTO DEVELOPING A COMPANY EXCUSE
ME TAKING THAT TECHNOLOGY OUT TO
HELP UNIVERSITY-BASED
RESEARCHERS WITH THIS.
SO THE REQUEST IS FOR A 5-YEAR
REISSUE OF THE PROGRAM WITH THE
CHANGES I OUTLINED ALLOWING
PHASE I AND EXPANDING
ELIGIBILITY TO FOREIGN TRAINEES
THAT HAVE THE RIGHT TO WORK IN
THE U.S.
SO SOME OF THE REASONS TO
REISSUE THE PROGRAM.
WE THINK THIS IS REALLY AN
EFFECTIVE WAY OF HELPING AND
ENHANCING THE SPIN OUT OF
TECHNOLOGIES FROM NCI-FUNDED
PROJECTS.
IT NICELY ALLIANCE WITH NATIONAL
CANCER PLAN GOALS, 3, 6 AND 8,
TO DEVELOP EFFECTIVE TREATMENT
AND ENGAGE EVERY PERSON AND OPT
MICE THE WORKFORCE.
PROVIDES A UNIQUE PROGRAM THAT
ALLOWS FOR TRAINING AND
MENTORSHIP THAT IS ABSENT
THROUGH THE REGULAR SBIR FUND
FUNDING.
AND IT USES THE SET ASIDE FUNDS
SO IT DOESN'T IMPACT RPG.
WE RECOMMEND THE RFA MECHANISM
BECAUSE IT ALLOWS FOR NCI TO
HAVE FURTHER OVERSIGHT OF THE
PEER REVIEW PROCESS WHICH IS
IMPORTANT IN HELPING TO MAKE
SURE WE GET REVIEWERS THAT ARE
FAMILIAR WITH BOTH
COMMERCIALIZATION AND ALSO
CAREER DEVELOPMENT PROGRAMS.
AND THE SET ASIDE IS THE
COMMITMENT TO THE PROGRAM.
I'LL END MY PRESENTATION THERE
AND TAKE ANY QUESTIONS.
>> THANK YOU VERY MUCH.
SO, PERHAPS WE COULD HAVE THE
COMMITTEE MEMBERS START THE
DISCUSSION.
>> OTIS, DO YOU WANT TO START OR
DO YOU WANT ME TO?
>> I WAS GOING TO SAY WE HAD A
WONDERFUL, GOOD CONVERSATION
SOME OF HIS COLLEAGUES AND OUR
GREATEST CONCERN IS THIS IS A
PROGRAM THAT IS WORTHWHILE AND
IS NOT BEING USED.
AND THEY RESPONDED TO ALL OF MY
CONCERNS.
I THINK ALL OF THE CONCERNS OF
THE SUB COMMITTEE.
AM I CORRECT?
>> YES.
IT'S EXCITING.
ANDRE SPOKE MULTIPLE TIMES ABOUT
IT, OF GETTING THEM INTO THE
PIPELINE.
I THINK WHAT I WASN'T AWARE OF
IS THE INTENSITY OF THE
MENTORSHIP IN THIS PROGRAM,
WHICH IS QUITE APPRAISING.
THESE APPLICANTS DO 100
INTERVIEWS AS PART OF THEIR
TRAINING.
IT IS RIGOROUS IN TERMS OF THE
MENTORSHIP.
THEY HAVE A BUSINESS MACHINE
TOR.
THE EXTENSIONS -- MENTOR -- THE
EXTENSION IS TWO YEARS IS
CRUCIAL BECAUSE THEY SPEND SO
MUCH TIME IN MENTORSHIP.
AND I THINK THE PHASE I ONLY IS
A GREAT IDEA BECAUSE IT CREATES
AN OPPORTUNITY.
I WOULD ADD WOON THING I JUST
LEARNED ABOUT.
WE HAD A LOT OF TALK ABOUT HOW
TO INCREASE THE VISIBILITY OF
THE PROGRAM.
AND I THINK IN AN INTERESTING
WAY, THE WHITE PAPER PROGRAM
WOULD ENCOURAGE PEOPLE TO
UNDERSTAND ABOUT THIS BECAUSE WE
HAVE TO WRITE -- WRITING TWO OR
THREE00 PAGES IS KIND OF FUN AND
I THINK YOU WOULD GET MORE
PEOPLE INTERESTED AND IT WOULD
BE MORE WORK BUT I THINK THAT IS
SOMETHING THAT YOU COULD
POTENTIALLY ADD TO THE PROGRAM
THAT WOULD HELP IT.
AND THE LAST THING WE DID TALK
ABOUT, MAKING SURE WE WERE
TRYING TO TAP INTO MINORITY
INVESTIGATORS.
AND I THINK ONE OF THE SPECIFIC
COMMENTS WAS THAT WHEN WE TALKED
ABOUT THE CANCER CENTERS AND
ALSO USE THE U54 NETWORK WHICH
IS ONE IN WHICH YOU HAVE
MINORITY-SERVING INSTITUTIONS
AND PARTNERSHIPS.
THOSE ARE ALREADY DONE AND WOULD
BE A GOOD WAY OF DELIVERING
MINORITY INSTITUTIONS.
>> THANK YOU FOR BRINGING THAT
UP.
I FORGOT TO MENTION THAT.
GREAT SUGGESTIONS AND WE'LL
DEFINITELY TAKE THAT INTO HEART
AND ALSO THE SUGGESTION ABOUT
WORKING WITH THE TRAINING
OFFICE, CO-BRANDING K99R00 WITH
SBTT PROGRAM TO HELP ENHANCE
AWARENESS.
REGARDING THE IDEA OF WHITE
PAPERS, WITH THE CONCEPT WE HAVE
IS FORMAL WHITE PAPER PROCESS
BECAUSE OF THE FEDERAL LAW
CONTRACTS HAVE A LOT OF STRICTER
RULES ABOUT HOW TO COMMUNICATE
WITH PEOPLE THAT ARE INTERESTED
IN APPLYING.
BECAUSE THE SBTT USES A GRANT
MECHANISM WE ENCOURAGE ALL THE
APPLICANTS TO CONTACT USES AND
SHOW SPECIFIC AIMS AND WE DO
HAVE A DISCUSSION WITH THEM, AND
GIVE THEM ADVICE HOW TO
STREAMLINE THEIR PROPOSALS PRIOR
TO THEM APPLYING.
WE DO MAKE THEM WORK.
IT IS A GOOD IDEA.
>> SO AGAIN, THE SPECIFIC AIMS
YOU MENTIONED, AGAIN, I WANT TO
ASK A SIMILAR QUESTION.
THE FOLLOW-UP OF HOW THE FUNDS
ARE SPENT OR WHERE THE PROGRAM
GOES INCORPORATE JUSTIFICATION
GIVEN BECAUSE OF SPECIFIC AIMS.
I MEAN THERE HAVE BEEN TIMES
WHERE THESE GRANTS ARE TAKEN AND
THEN THE COMPANY GOES IN A
DIFFERENT DIRECTION OR SELLS
ITSELF.
THINGS THAT ARE UNRELATED TO
SPECIFIC AIMS.
AND I THINK FOR US TOO, TO
UNDERSTAND THE -- WHAT THE
SCIENTIFIC BASIS WAS THE
TRAINING, CORE TRAINING -- IN
PAST PRESENTATIONS, THEY
MENTIONED THE GARLAND VENDOR AND
THEIR TEXTBOOK THAT WAS WRITTEN
BEFORE 1998.
-- I'M SORRY, BEFORE 2018, LIKE
2016.
I THINK YOU KNOW THE REGULATORY
SCIENCE FIELD HAS REALLY JUMPS A
LOT IN THE PAST FEW YEARS IN
TERMS OF WHAT IS REALLY NEEDED
AND HOW TO MAKE TRIALS MORE
EFFICIENT WITH NEW GUIDANCES
ABOUT EVERY FEW MONTHS.
CAN YOU HELP US UNDERSTAND?
IS THE CORE TRAINING THAT IS
PROVIDED AND ORGANIZED, DOES IT
ALSO ALIGN WITH SOME OF THESE
MORE MODERN UPDATED 2023, 24
GUIDANCES?
>> SO THE ICORE TRAINING PROGRAM
HAS BEEN RUNNING AT NIH FOR --
LIKE A LIVING PROCESS AND IT IS
CONSTANTLY UPDATED.
AND THE GOAL OF THE TRAINING IS
NOT SPOON FEEDING THE
PARTICIPANTS ANSWERS.
IT'S TRAINING THEM TO DO THESE
INTERVIEWS AND COVER WHERE THE
ANSWERS ARE AND HELP THEM TO GO
IN THE RIGHT DIRECTIONS.
I THINK THEY ARE GETTING UPDATED
INFORMATION BUT IT DOESN'T AIM
TO PROVIDE THEM WITH ALL THE
ANSWERS.
WE HELP THEM GO IN THE RIGHT
DIRECTION AND THEN YOUR EARLIER
COMMENT ABOUT CONCERN ABOUT
COMPANIES RECEIVING FUNDING AND
GOING IN DIFFERENT DIRECTIONS --
WITH THE FAST TRACK, IN ORDER TO
TRANSITION TO THE PHASE II
PROJECT TO GET THAT LARGER TWO
MILLION DOLLAR LEVEL OF FUNDING,
THEY NEED TO SHOW THEY MET THE
ORIGINAL GOALS.
ANY CHANGES IN SCOPE TO THE
PHASE I NEED TO BE AGREED IN
WRITING PRIOR TO THEM EXECUTING
ON THAT AND THEN IN ORDER --
THEY JUST RECEIVED PHASE I, AND
IN ORDER TO RECEIVE PHASE II
FUNDING, THEY NEED TO
DEMONSTRATE THEY HAD
ACCOMPLISHED THE PHASE I PROJECT
SUCCESSFULLY.
>> I JUST HAD A SUGGESTION ABOUT
THE TRAINING PART.
THERE ARE SEVERAL UNIVERSITIES
THAT HAVE VERY ROBUST TRAINING
FOR ENTREPRENEURSHIP AND
INNOVATION LIKE STANFORD AND
MICHIGAN.
HAVE YOU PARTNERED WITH ANY OF
THOSE INSTITUTIONS FOR THEIR
EXPERIENCE IN EDUCATION AND
GETTING YOUR PRODUCT?
IT MIGHT BE HELPFUL TO DO --
>> WE DO HAVE CONTACTS WITH A
NUMBER OF THOSE PROGRAMS.
WITH THE SBTT WE'RE NOT PUSHING
ANY ONE MODEL.
WE PROVIDE THE ICORE TRAINING
BUT WE ARE LOOKING AS PART OF
THE APPLICATION, WE NEED TO
PROVIDE A ROBUST TRAINING ON TOP
OF THE MENTORING AND IT WILL
EXPLAIN WHAT OTHER RESOURCES
THEY ARE ABLE TO ACCESS.
SO --
>> BECAUSE THOSE PLACES HAVE
REALLY ROBUST TRAINING PROGRAMS
THAT THEY MIGHT BE ABLE TO
CONNECT WITH JUST AS A COMMENT.
>> THAT IS GREAT.
THANK YOU.
>> I DON'T SEE ANY FURTHER
HANDS.
I THINK WE CAN MOVE.
>> CAN I MAKE A MOTION?
>> YES, PLEASE DO.
>> SECOND.
>> AND THE MOTION WAS FOR
CONCURRENCE TO BE CLEAR.
>> YES.
>> OKAY.
ANY FURTHER DISCUSSION?
LOOKING FOR ANY VOTES OF NON
CONCURRENCE.
>> IT APPEARS TO BE UNANIMOUS.
>> THANK YOU ALL AND THAT WRAPS
UP OUR BSA BUSINESS.
JOHN, BACK OVER TO YOU.
>> THE BOARD WILL NOW CONSIDER
ONGOING NEW BUSINESS.
THERE WERE TWO NATURAL CANCER
ADVISORY BOARD SUBCOMMITTEE
MEETINGS YESTERDAY.
THE SUBCOMMITTEE CHAIRS WILL
GIVE THEIR REPORTS.
FIRST REPORT WILL BE GIVEN BY
DR. SUZANNE WHO IS CHAIR OF THE
SUB COMMITTEE ON CANCER CENTERS.
SUSAN?
>> THANK YOU VERY MUCH.
WE MET YESTERDAY FROM 1-2 P.M.
EASTERN STANDARD TIME BASED ON
THE DISCUSSIONS WE HAD AT THE
LAST MEETING, WE HAD OTHERS
ADDRESS SEVERAL OF THE ISSUES
THAT I THINK WERE RAISED.
HE DID A FANTASTIC JOB.
THE ATTENDANCE WAS GREAT AND
GAVE TWO PRESENTATIONS.
ONE WAS AN UPDATE ON THE CANCER
CENTER PROGRAM SO TAKING US
THROUGH THE HISTORY OF SORT OF
HOW HE HELPED TO IMPLEMENT A
FUNDING STRATEGY THAT WOULD HELP
SUPPORT EQUITABLE REVIEW BASED
ON MERIT AND SLIDES OF CANCER
CENTER ON 3 PHASES THAT STARTED
IN 2016 AND BROUGHT US ALL THE
WAY UP TO TODAY WHERE HE'S NOW
FOCUSED OR WE ARE FOCUSED ON
THOSE NEW AREAS AND HISTORICALLY
BEEN UNDER FUNDED.
HE ALSO COVERED ANOTHER OFFICE
OF CANCER CENTER PRIORITY, WHICH
IS INCREASING THE NUMBER OF NEW
CANCER CENTERS.
THERE WAS REALLY A ROBUST
DISCUSSION BUT EQUALITY AND
QUANTITY AND MAKING SURE WE
PRESERVED THAT TO REFLECT THE
HIGH QUALITY OF WHAT GOES ON AT
NCI CENTERS AND REAFFIRMED THAT
COMMITMENT.
AND TALKED ABOUT THE REVIEW
PROCESS AND WHAT THE TRADEOFF IS
FOR THE INTENSITY OF THE REVIEW
PROCESS VERSUS MAKING SURE THAT
CANCER CENTERS GET TO SHOW THEIR
CANCER CENTER NATURE, ET CETERA
AND WHY WE'RE KIND OF USING
REVIEW PROCESS WE CURRENTLY
HAVE.
AND THEN WE TOUCHED ON
SUPPLEMENT AND THE VALUE THAT
THIS RELATIVELY LOW COST
INVESTMENT HAS HAD IN TERMS OF
BEING ABLE TO SHIFT CANCER
CENTERS TO ALSO ALIGN WITH NCI'S
PRIORITIES.
THAT'S TYPICALLY DONE IN
COLLABORATION WITH SOME OF THE
DIVISIONS OFFICES AND CENTERS AT
NCI AND HE WOULD LOVE TO SEE
THAT CONTINUE, BUT ALSO
POTENTIALLY TO HAVE THE OFFICE
OF CANS CENTERS HAVE A POOL OF
FUNDS TO BE ABLE TO ISSUE
SUPPLEMENTS ON THEIR OWN.
SO THAT WAS THE FIRST
PRESENTATION.
THE SECOND PRESENTATION WE
TALKED ABOUT, REVISION OF THE
UPCOMING CCSG GUIDELINES AND
FOCUS ON A FEW KEY AREAS.
ONE IS PED, THE NEWEST AREA.
HE REVIEWED HOW THE FIRST 20
HAVE GONE AND SOME OF THE
LESSONS LEARNED AND BASED ON THE
FEEDBACK AND DISCUSSION WE HAD
IN HIS OWN THINKING, HE TALKED
ABOUT AREAS WHERE HE IS GOING
TO -- WHERE THE GUIDELINES WILL
CLARIFY A LITTLE BIT MORE SOME
OF THE EXPECTATIONS, INCLUDING
BASELINE DIVERSITY OF DATA FOR
CANCER CENTERS AND TALKING ABOUT
THE INTERSECTION OF [ INAUDIBLE
AND HOW WE ARE INVOLVING STAFF
IN THE DIVERSITY ASSESSMENT OF
THE CENTER.
AND INCORPORATE PED INITIATIVES
INTO THE STRATEGIC PLAN.
AND TALKED ABOUT CLARIFYING
TERMINOLOGY, BOTH FOR CANCER
CENTERS AND HOW WE COMMUNICATE
TO THE PUBLIC ABOUT DIFFERENT
AREAS WITHIN CCSG APPLICATIONS
THAT MAY SOUND SIMILAR LIKE PED
AND COE.
FOR ANSWER TECH THERE WAS A
DISCUSSION ABOUT ARE WE READ TOW
EXPAND TO A 12-PAGE SECTION?
THERE WAS NOW THE GENERAL
CONSENSUS.
OUR GROUP WAS NO, WE HAVE ENOUGH
PAGES.
SO THAT'S KIND OF WHERE WE LEFT
THAT.
THERE WAS DISCUSSION REGARDING
COE AND REALLY ACKNOWLEDGING
THAT A CURRENT STATE IS UNDER
FUNDED AND HOW WE CAN SORT OF
BETTER SUPPORT WHAT IS REALLY A
CROSSCUTTING INITIATIVE ACROSS
ALL THE CANCER CENTERS.
WE HAD A LITTLE BIT OF -- WE HAD
A GOOD DISCUSSION ABOUT CANCER
CENTERS AND THE ISSUES THAT CAME
UP LAST TIME IN OUR MEETING
ACCEPTING MEDICAID AND IT WAS
NICE TO HAVE PEOPLE'S INPUT FROM
ALL DIRECTIONS, WHICH IS OF
COURSE WE WANT TO SERVE THE
UNDERSERVED BUT ALSO HAVE TO
THINK ABOUT THAT THE CCSC ASK A
RESEARCH-FOCUSED GRANT WHICH MAY
LIMIT WHAT WE ARE ABLE TO
MANDATE PLUS THE CONSIDERATIONS
THAT SEVERAL CENTER DIRECTORS
BROUGHT UP OF UNIQUE
CIRCUMSTANCES IN THEIR STATE.
AND ONE PLACE WHERE WE LANDED
THAT WE THOUGHT WAS KIND OF A
GOOD INTERSECTION WAS CLINICAL
TRIALS AND HOW DO WE SUPPORT
PATIENTS WHO ARE INSURED BY
MEDICAID WITHIN CLINICAL TRIALS
WHICH FELT A LITTLE MORE IN
SCOPE OF CCSC GIVEN OUR FOCUS ON
RESEARCH THAT IS THERAPEUTIC
CLINICAL TRIALS.
AND THEN, JUST TO CONCLUDE, THE
NCAB OFFERED SUPPORT IN WHATEVER
WAY IS HELPFUL AND ALLOWABLE.
WE ALL HAVE OPINIONS ABOUT THE
UPDATES FOR THE GUIDELINES AND
WORKING WITHIN WHATEVER
PARAMETERS.
THAT IS SOMETHING WE WOULD LIKE
TO CONTINUE TO DO AND THEN THERE
WAS ALSO A GOOD SUGGESTION WHICH
HENRY SAID HE WOULD LOOK INTO,
WHICH IS POTENTIALLY, COULD WE
GET FURTHER COMMENTS LIKE PUBLIC
COMMENT ISN'T THE RIGHT WORD BUT
A PROCESS WHERE SOME OF THE NEW
CONCEPTS ARE VETTED IN A BROADER
SETTING FOR PEOPLE WHO ARE
STAKEHOLDERS.
AND THAT WAS IT.
>> THANK YOU, SUSAN.
IT WAS A GREAT MEETING.
SO NOW THE MEMBERS WILL NOW VOTE
TO ACCEPT SUSAN'S REPORT.
IS THERE A MOTION?
>> SO MOVED.
>> SECOND.
>> GREAT.
SHOULD WE NOW NEED A VOTE?
I'LL FIRST ASK ARE THERE ANY
NAYs?
OR ABSTENTIONS?
THERE BEING NONE, I THINK IT'S
UNANIMOUS.
>> UNANIMOUS.
>> SO THE NEXT SUBCOMMITTEE
REPORT WILL BE BROUGHT TO US BY
THE CHAIR OF THE AD-HOC SUB
COMMITTEE ON EXPERIMENTAL
THERAPEUTICS.
RICHARD?
>> THANK YOU VERY MUCH.
THIS AD-HOC SUBCOMMITTEE WAS
ESTABLISHED IN 2006 WITH A
SPECIFIC MISSION AND WITH A
PARTICULAR PURPOSE AND THEN
DIDN'T MEET FOR YEARS, FOR NINE
YEARS.
BUT RECENTLY OVER THE LAST FEW
YEARS, THERE HAS BEEN A LOT MORE
INTEREST IN EXPERIMENTAL
THERAPEUTICS AND WHAT I DID IN
ORDER TO EVALUATE WHAT HAS
HAPPENED IN THE PAST AND WHAT
HAS BEEN GOING ON, WE READ THE
FOUR YEARS OF NOTES AND MINUTES
AND THEN ASKED THE DOCTOR TO
RESPOND TO THE DIFFERENT
REQUESTS THE COMMITTEE HAD MADE.
NOW THIS PARTICULAR COMMITTEE
YESTERDAY HAD 100% PARTICIPATION
OF THE MEMBERS WHICH
DEMONSTRATED THEIR COMMITMENT
AND ALSO INTEREST AND I THINK
THIS WILL GO VERY VALUABLE AS WE
GO FORWARD.
SO THEN THE DOCTOR GAVE A VERY
ROBUST REVIEW OF THE
DEVELOPMENTAL OF THERAPEUTICS
PROGRAM.
OUTLINING EACH AND EVERY ONE OF
THE ASPECTS OF THE PROGRAM THAT
ANSWERED SPECIFICALLY THE
QUESTIONS OVER THE LAST FOUR
YEARS AND PARTICULARLY LAST
COUPLE OF YEARS THAT THE MEMBERS
REQUESTED AND SO THEREFORE THE
NCAB MEMBERS ON THIS COMMITTEE
ARE HAVING IMPACT AND INPUT BOTH
OF WHICH WERE GREATLY
APPRECIATED.
AND SPECIFICALLY THE DOCTOR
HIGHLIGHTED COMPLIMENTS
ACROSS -- IT WAS INTERESTED BY
THE SUBCOMMITTEE, PARTICULARLY
CELL THERAPY, CONDUCTING SMALL
TRIALS AND RATIONAL DRUG
DISCOVERY AS WELL AS SUPPORTING
TRANSLATIONAL RESEARCH TRAINING.
AND SO THE SUBCOMMITTEE WAS VERY
APPRECIATIVE OF THE EFFORTS.
OTHER DOCTORS GAVE SOME VERY
IMPORTANT DISCUSSION POINTS AND
THESE WERE TAKEN SERIOUSLY AND
WE'LL REPORT BACK.
I THINK THE MAIN THING THAT --
ONE OTHER THING IS THAT EYE
CHEAP CAME ACROSS OF INTERACTION
WITH THE FDA AND THEN DR. DORE
SHAW, JIM GAVE A DESCRIPTION --
DOROSHOW -- OF THE FACT THAT
THIS GOES ON COMMONLY SO IT GAVE
THE COMMITTEE THE FEELING THAT
ONCE AGAIN THEIR THOUGHTS AND
THEIR IDEAS WERE BEING ACTED
UPON AND HAVING IMPACT.
AT THE END OF THE MEETING, WE
DECIDED WE THOUGHT THE MISSION
NEEDED UPGRADING THROUGH 2023.
WE DECIDED TO DO, WITH THE HELP
OF THE NCI STAFF, CREATE A NEW
MISSION FOR THE SUBCOMMITTEE AND
THEN AFTER WORKING ON IT OVER
THE NEXT FEW MONTHS, PRESENT IT
TO THE COMMITTEE, TO THE NCAB
FOR APPROVAL.
SO I THINK THE INTEREST AND
ENTHUSIASM FOR THE SUBCOMMITTEE
IS IN VIG RATED AND WORKING WITH
THE NCI STAFF CAREFULLY AND
CLOSELY.
SO THANK YOU.
>> THANK YOU.
CAN THE N CAT MEMBERS NEED TO
VOTE TO ACCEPT THE REPORT.
IS THERE A MOTION?
>> I MOVE APPROVAL.
>> SECOND?
>> SECOND.
>> ANY FURTHER DISCUSSION?
IF NOT WE SHOULD VOTE.
I WILL ASK, ARE THERE ANY NAY
NAYs?
ABSTENTIONS?
>> IT'S UNANIMOUS.
>> THANK YOU.
WE'LL NOW MOVE ON TO OTHER
BUSINESS.
A FEW BULLET POINTS HERE.
THE ANNUAL BSA CONCEPT REVIEW
REPORT IS POSTED ON THE MEMBERS
ONLY WEBSITE.
AND AS REQUESTED PRIOR YEARS OF
THE REPORT, HAVE BEEN ARCHIVED
SO YOU CAN HAVE ACCESS TO THOSE
AS WELL.
I'LL NOW ASK THE BOARDS, ARE
THERE OTHER THOUGHTS, ISSUES,
CONCERNS, RECOMMENDATIONS THAT
ANYONE WOULD LIKE TO SHARE TODAY
WITH THE BOARDS OR WITH THE NCI
THAT MIGHT CONSIDER FURTHER
DISCUSSION?
RICHARD IS YOUR HAND UP?
>> YES, IT IS.
THANK YOU.
>> THIS MAY NOT BE POSSIBLE BUT
THIS ECHOS ONE OF OUR COLLEAGUES
WHOA MENTIONED IT EARLIER WHICH
IS AN IN-PERSON MEETING IS VERY
VALUABLE, I THINK, IN CREATING
INTERACTION AND DISCUSSION,
CAMARADERIE.
AND I KNOW THAT WE OBVIOUSLY
THIS IS VIRTUAL.
IT WAS SUPPOSED TO BE IN-PERSON.
THE NEXT IN-PERSON IS IN JUNE.
AND I WAS WONDERING IF IT IS
POSSIBLE THAT MAYBE THE FEBRUARY
MEETING WOULD BE IN-PERSON SO WE
HAVE THE OPPORTUNITY OF
INTERACTING WITH EACH OTHER IN
THE SAME ROOM?
>> I PRESUME THAT QUESTION IS
DIRECTED TO ME.
THE WEATHER MAY NOT -- IT
PROBABLY WILL NOT BE CONDUCIVE.
SO, WITH COVID BECAME AN ISSUE,
IT WASN'T DIFFICULT FOR NCI TO
TRANSITION SINCE WE HAVE BEEN
DOING VIRTUALLY FOR YEARS.
SO AT THIS POINT, I WILL SAY NO,
THERE WILL NOT BE A FACE-TO-FACE
MEETING.
>> THANKS, PAULET.
I WOULD SAY MY OWN EXPERIENCE IS
TO NOT GO EAST BETWEEN JANUARY
AND MAY.
SO I WOULD AGREE BUT I ALSO
AGREE WITH RICHARD THAT
FACE-TO-FACE IN-PERSON MEETINGS,
THERE IS IT A DIFFERENT DYNAMIC
AND A DIFFERENT LEVEL OF
EFFECTIVENESS SOMETIMES.
SO I AGREE.
I THINK WE HEAR YOU LOUD AND
CLEAR.
>> AND I AGREE WITH RICHARD
ALSO.
JUST NOT IN FEBRUARY.
>> WE CAN AGREE WITH EACH OTHER
BUT FLOTIN THE SAME ZIP CODE.
>> THAT'S RIGHT.
>> I APOLOGIZE.
MY HAND RAISE DOESN'T WORK VERY
WELL.
I WAS GOING TO SUGGEST, TO THE
NCAB THAT WE MIGHT THINK ABOUT
INVITING -- TO GIVE A TALK FOR
US BECAUSE WE DO HAVE OVER THE
YEARS, AND JIM SPOKE TO IT AT
OUR MEETING, AS RICHARD POINTED
OUT, WE HAVE A CLOSE WORKING
RELATIONSHIP WITH FDA AND HE
USED TO COME TO THIS BOARD
MEETING ALL THE TIME BECAUSE HE
IS AN AD-HOC MEMBER.
I SUSPECT PAULET, I DON'T KNOW
IF HE IS STILL AN AD-HOC MEMBER.
>> HE IS.
>> -- TO GET A SENSE OF WHERE
ARE WE IN THE CANCER
THERAPEUTICS SPACE.
I THINK HE WOULD BE HAPPY TO DO
IT.
I THINK IT WOULD BE A GOOD THING
TO HAVE SOME DISCUSSION ABOUT
WHERE HE SEES THE FIELD GOING
AND HE'S GOT HIS HANDS FULL AT
THE MOMENT BUT I THINK HE WOULD
BE VERY HAPPY TO DO IT.
>> I HAVE THAT ON MY --
>> YOU DEFINITELY JUMPED FORWARD
AND A GOOD SEGUE TO FUTURE
AGENDA ITEMS.
ANY FUTURE AGENDA ITEMS ANYONE
WOULD LIKE TO HAVE ADDRESSEDDED?
>> ABOUT A YEAR AGO WE WERE
TALKING ABOUT THE CLINICAL
TRIALS ACCELERATOR AND IT WOULD
BE GREAT TO HEAR AN UPDATE IF
THAT GOT STARTED AND WHAT IS
HAPPENING WITH THAT.
JUST AN IDEA.
>> FROM MY PERSPECTIVE, GIVEN
THE KIND OF ENVIRONMENT -- I DO
REMEMBER WE HAD A CONVERSATION
ABOUT WHAT COULD WE DO AS A
BOARD REPORTS TO ASSIST ON THE
NCI?
BEYOND THE MEETINGS.
AND I KNOW WE HAVE TO BE VERY
CAREFUL.
WE WORK VERY CLOSELY WITH PAUL
THE TO MAKE SURE WE VET WHATEVER
THAT MIGHT BE.
I THINK THAT IS SOMETHING WE
HAVE TO FOLLOW-UP ON AND I'LL
TAKE IT UPON MYSELF TO ENGAGE
WITH THOSE CONVERSATIONS JUST TO
SEE IF THERE IS ANYTHING WE CAN
DO.
HOWARD?
>> I THINK TWO THINGS WOULD HELP
THE COMMUNITY WORKING IN
ONCOLOGY AND CELL THERAPIES.
ONE IS ANY EXPERIENCES THAT CAN
BE SHARED FROM THE ORGANOID WORK
THAT IS ONGOING.
I HEARD OF SOME SPONSORS BEING
ABLE TO DO ORGANOID STUDIES AND
BY PASS THE OLD-FASHIONED WAY OF
USING IRRELEVANT MOUSE MODELS.
AS A WAY TO HELP JUSTIFY A
SUCCESSFUL IND.
SO, HAVING US LEARN MORE ABOUT
THAT WOULD BE USEFUL.
THE OTHER IS, ANY PROGRESS THAT
IS SIMILARLY FROM THE MOONSHOT
PROGRAM ON BIOMARKERS THAT GARY
KELLOGG HAS BEEN RUNNING.
I SUGGESTED SPECIFIC TO IMMUNE
ONCOLOGY.
THEY ARE JUST STARTING THE
PUBLISHED WORK.
WE HAVE HAD ONE TALK FROM HELEN
CHEN ABOUT A YEAR OR SO AGO BUT
THERE HAS BEEN 3 PUBLICATIONS
SINCE THEN THAT HAVE COME OUT
MORE COMING AND OTHERS MAY BE
AWARE OF.
I'M INTERESTED WORK ON MDSCs
THAT CAN BE MONITORED FOR RESIST
EBBS USING TECHNOLOGIES.
THAT'S JUST ONE EXAMPLE.
THERE WERE MANY AT THE MEETING
JUST A MONTH AGO.
AND I THINK MAYBE THEY WOULD BE
REALLY HELPFUL.
>> OKAY, WE HAVE IT.
>> THANK YOU.
>> I'M SORRY.
>> I THINK I HAD MY HAND UP
FIRST BUT GO AHEAD.
>> YOU GO FIRST.
>> OKAY.
I'LL TRY TO KEEP MINE QUICK.
SO ONE OF THE THINGS THAT I
NOTICED IS THAT CANCER CENTERS
SEEM TO BE MORE AND MORE
ENCOURAGED TO INFLUENCE POLICY
AND I KNOW THERE WAS DISCUSSION
IN THIS GROUP EARLIER TODAY
ABOUT THE IMPORTANCE OF POLICY
AROUND ACCESS TO LUNG CANCER
SCREENING AND I THINK IT WOULD
BE GREAT TO REALLY UNDERSTAND
WHAT HAS BEEN THE SUCCESSFUL
POLICY INITIATIVESES AND WHAT
MIGHT BE SOME OPPORTUNITIES TO
MOVE POLICY FORWARD AND HOW TO
BEST DO THAT.
>> THIS IS PERHAPS SOMEWHAT
WEIGHTY TOPIC WHICH WE TOUCHED
ON YESTERDAY.
IN ONE OF THE SESSIONS.
AND THE ISSUES ABOUT DIVERSITY
IN THE WORKFORCE AND HOW THE
STRATEGIES WE NEED TO ADOPT TO
USE TO BE SUCCESSFUL AND ALSO BE
ATTENTIVE TO SOME OF THE AREAS
OF -- CHALLENGES AND CONCERNS
THAT HAVE A REASON.
SO I'M WONDERING IF THERE MIGHT
BE AN OPPORTUNITY FOR US TO
COLLECT DUPLICATES AND WHAT
STRATEGY THERE MIGHT BE TO
ADDRESS ISSUES OF DIVERSITY
WITHIN THE CANCER PROGRAMS AND
WE SAID IT YESTERDAY.
I DON'T THINK PLANS WILL WORK AS
WE THINK -- SO WHAT I'M HOPING
IS WE FIND SOME AVENUE A WAY FOR
US TO CREATE A CONCENTRATED
DISCUSSION AROUND ISSUES OF
ADVANCED DIVERSITY AND CANCER
PROGRAMS.
>> I HAVE FOUR HANDS AND WE'LL
GO IN THIS ORDER.
WE HAVE RAY, SYLVIA, MICHELLE
AND KARIN.
>> THANKS, JOHN.
SO, IN TERMS OF ACCESS TO
CLINICAL TRIALS AND SO ON,
OBJECTIVE EVIDENCE SUGGESTS
ABOUT A THIRD OF THE REASON WHY
PEOPLE DON'T GET INTO CLINICAL
TRIALS IS THE ELIGIBILITY
CRITERIA ARE TOO STRINGENT.
SO SEVER YEARS AGO, FRIENDS OF
CANCER RESEARCH, NCI,FDI, GOT
TOGETHER AND IN TWO CYCLES WE
DID WORK TO MAKE PROPOSALS TO
SIMPLIFY CLINICAL TRIALS
ELIGIBILITY CRITERIA.
AND THE IDEA OF INVITING OR
JOGGING MY MEMORY ABOUT THIS
BECAUSE IT'S BEEN SEVERAL YEARS
NOW AND AS CHAIR OF ASCO'S
RESEARCH COMMITTEE, I ASK THAT
WE GO BACK AND SEE WHAT IS THE
IMPLEMENTATION OF THESE
PROPOSALS HAS BEEN LIKE AND THE
EARLY FEEDBACK WE ARE GETTING IS
THAT THERE IS RESISTANCE AT
VARIOUS LEVELS INCLUDING WITHIN
THE FDA.
I WONDER SINCE THE NCI WAS PART
OF THAT EFFORT AND THE NCI
ACTUALLY TOOK THE PROPOSALS AND
MADE SOME EFFORT TO STREAMLINE
THINGS, WHETHER THE BOARD
COULDN'T HAVE A SESSION TO TAKE
A LOOK AT THIS.
WHAT IS THE CURRENT STATUS OF
IMPLEMENTING THESE
RECOMMENDATIONS?
WHERE ARE THE BARRIERS AND SO
ON?
>> THAT COULD POSSIBLY TIE INTO
A DISCUSSION WITH RICK.
THANKS.
SYLVIA?
>> THANK YOU.
I'D LIKE TO ADVOCATE FOR MORE
DISCUSSIONS OF THE NCI'S AI AND
DATA SCIENCE STRATEGY AROUND
BASIC TRANSLATIONAL AND CLINICAL
RESEARCH.
DISCUSSIONS THAT FUTURE BSA AND
CAB MEETINGS.
I THINK WE ARE SEEING A LOT OF
HEADS NODDING.
WE ARE LIVING THROUGH
UNPRECEDENTED TIMES ESPECIALLY
WITH THE REGENERATIVE AI AND IT
IS GREAT TO SEE WE PARTICIPATED
WITH ARPA-H IN THE RECENT
BIODATA MEDICAL FRAMEWORK
INITIATIVE.
I'D LIKE TO REQUEST A
PRESENTATION ON THE JOINT
INITIATIVE BETWEEN NCI AND
ARPA-H AT A FUTURE BSA MEETING
AND ANY OTHER NCI INITIATIVES
AND EFFORTS AROUND AI AND DATA
SCIENCE.
>> I AGREE.
THAT'S A GREAT TOPIC FOR A
FUTURE MEETING.
MICHELLE.
>> THANK YOU, JOHN.
AN AREA THAT IS OF GREAT
INTEREST TO NCI AND NCI IS
PLANNING SOME VERY IMPACTFUL
STUDIES, AS WELL AS OF INTEREST
TO INDUSTRY, ACK DEEM QUAAND
OTHER GROUPS IS MULTICANCER
DETECTION TESTS.
AND FDA IS NOW LAUNCHING ITS
EVALUATION OF THESE TESTS AND
SEEKING ADDITIONAL INFORMATION.
SO THIS MIGHT BE A GOOD TIME FOR
US TO WEIGH IN ON THESE TOPICS.
>> THANK YOU, MICHELLE.
KARIN.
>> I JUST WANT TO WEAR TWO HATS
FOR A SECOND.
SO ONE IS AS A FORMER CANCER
CENTER DIRECTOR.
IT CAN SOMETIMES BE VERY
DIFFICULT FOR THE 501(C)3s
ESPECIALLY IF THEY ARE A STATE
INSTITUTION, TO ENGAGE IN
POLICY, ESPECIALLY STATE-RELATED
POLICY CHANGE.
THAT DOESN'T MEAN THAT THEY ARE
NOT -- THAT SOME OF THESE
CENTERS ARE NOT HAVING
INCREDIBLE IMPACT AT THE STATE
AND NATIONAL LEVEL ON
CANCER-RELATED POLICY OR FROM
SCREENING TO EARLY DETECTION.
I'M NOT TELLING YOU SOMETHING
YOU DIDN'T KNOW.
BUT, THIS IS AN AREA WHERE WE DO
COLLABORATE QUITE A LOT WITH THE
CANCER CENTERS AND CAN TAKE THE
STORIES AND SCIENCE AND PUSH IT
FORWARD INTO A POLICY CHANGE
THAT THEN WE CERTAINLY ENCOURAGE
THE CANCER CENTERS TO INCLUDE IN
THEIR CCSG.
THE OFFER IS, IF THIS IS
HELPFUL, BECAUSE WE DO PROFILE
THIS OURSELVES, WHAT PROGRESS WE
HAVE MADE.
IS IF YOU EVER WANT, HAVE A
REPORT FROM ACS CAN TO PRESENT
TO THE NCA OR BSA OF HERE IS
FEDERAL AND STATE LEVEL, THE
POLICIES THAT -- POLICY CHANGES
ENABLED BY SCIENCE THAT CAME
FROM THE CANCER CENTERS.
SO JUST AN OFFER.
>> THANKS, KARIN.
>> THAT WOULD BE AMAZING.
>> THANKS.
SO I BELIEVE PAULET HAS BEEN
CAPTURING ALL THESE GREAT IDEAS.
AND IF THERE ARE ANY OTHER IDEAS
FOR FUTURE TOPICS, JUST SEND
THOSE SUGGESTIONS ON TO PALEATE.
INDIVIDUAL BOARD SUGGESTIONS
SHOULD BE SENT TO THE RESPECTIVE
BOARD CHAIR OR PAULET AS WELL.
SO THERE BEING NO FURTHER
BUSINESS, THE MEETING IS NOW
ADJOURNED.
I'D LIKE TO WISH EVERYBODY A
WONDERFUL HOLIDAY SEASON AND I
WILL SEE YOU VIRTUALLY IN
FEBRUARY.
THANK YOU, EVERYONE.