>> TODAY'S MEETING WRITING TO
DR. PAULETTE GRAY EXECUTIVE
SECRETARY OF THE NCAB WITHIN 10
DAYS OF THE MEETING, ANY WRITTEN
QUIETS OR STATEMENTS RECEIVED BY
MEMBERS OF THE PUBLIC WILL
RECEIVE CAREFUL CONSIDERATION,
THE FOLLOWING MEMBERS ARE
PARTICIPATING IN TODAY'S
MEETING, DR. OSMAN, DR. HIEBERT,
DR. P A SKETT, AND ARE THERE ANY
QUESTIONS REGARDING PROCESS.
>> HEARING NONE, DR. OLI-OSMAN,
YOU MAY BEGIN THE MEETING.
>> THANK YOU VERY MUCH.
BEFORE WE START I WOULD LIKE TO
REMIND US OF THE MANDATE OR
MISSION STATEMENT OF THE AD HOC
COMMITTEE ON GLOBAL HEALTH
CANCER RESEARCH AND LET ME ALSO
SAY THAT DR. CHAPP A S, WHENEVER
HE JOINS, WE WILL TRY TO SQUEEZE
HIM IN, SO THE PURPOSE OF THIS
NCAB IS THE NCI DIRECTOR ON
STRATEGIC APPROACHES AND
OPPORTUNITIES TO ENHANCE NCI'S
CONTRIBUTION TO GLOBAL CANCER
RESEARCH.
THIS GROUP WILL PROVIDE
LEADERSHIP AND EXPERTISE WITH
THE INTENTION OF OFFERING INPUT
ON PROPOSING INITIATIVES AND
CONCEPTS AND PARTNERSHIPS ALL
PROVIDING INFORMATION TO HELP
BEDETERMINE PRIORITIES OF NEW
PROSPECTS FOR NCI AND GLOBAL
CANCER RESEARCH.
IN ADDITION THE SUBCOMMITTEE MAY
SEARCH FOR NEW OPPORTUNITIES
WHERE THE NCI CAN CONTRIBUTE
INTERNATIONALLY, SUCH AS BY
ADVANCING CLINICAL CANCER
RESEARCH, BUILDING AND BRIDGING
TECHNOLOGY, RESEARCH CAPACITY
AND PROMOTING TRAINING PROGRAMS,
SO IT'S QUITE A BROAD MANDATE
AND ALLOWS US TO DO THINGS IN
VARIOUS AREAS.
SO, LET ME TAKE THE OPPORTUNITY
TO WELCOME NEW MEMBERS TO THE
SUBCOMMITTEE, I THINK YOU
HAVEN'T GOTTEN THE FINAL LIST
YET, BUT I THINK MOST OF HAVE
YOU BEEN INFORMED OF IT.
THE--AT THE LAST MEETING WHICH
WAS HELD IN AUGUST OF LAST YEAR,
JUST RIGHT AT THE NEXT SURGE OF
THE COVID-19 EPIDEMIC, WE HAD
THE OPPORTUNITY TO WELCOME
DR. PATTY GRAVITZ, THE DEPUTY
DIRECTOR OF THE CENTER AND TO
GIVE US A RIVETTING PRESENTATION
ON IMPLEMENTATION SCIENCE, I
THINK SHE'S GOTTEN SEGHTSED NOW.
TODAY'S MEETING WILL BE FAIRLY
STRAIGHT FORWARD AND FOCUS ON 1
TOPIC BUT BEFORE THRA, LET ME
TAKE THE OPPORTUNITY TO WELCOME
GUESTS AND IT WILL BE INTRODUCED
LATER, JUST MENTIONED JUST NOW,
DR. SAMIR, FROM THE INFECTIOUS
DISEASES IN UGANDA AND
DR. HANNAH SIMMONS, FROM
[INDISCERNIBLE] UNIVERSITY OF
SOUTH AFFRIC ATHEY WILL BE
INTRODUCED LATER MORE IN THE
MEETING.
SO, AGAIN, TODAY'S MEETING WILL
BE VERY FOCUSED, THE DOCTOR
POWELL, THE DIRECTOR FOR THE
CENTER FOR GLOBAL CANCER
RESEARCH WILL GIVE US A BRIEF
PRESENTATION ABOUT THE INSTITUTE
AND HOPEFULLY AT THE NEXT
MEETING, WE WILL HAVE MORE TIME
FOR HIP TO UPDATE US.
IT WOULD HAVE BEEN ALMOST 2
YEARS IN THE JOB AS TO WHERE
THINGS ARE GOING SO, WITHOUT
MUCH ADO, I WILL CALL ON SATISH,
TO GIVE US A BRIEF UPDATE AND
THEN WE WILL MOVE ON TO THE MAIN
PART OF THE PROGRAM.
>> OKAY.
I WILLS ASSUME EVERYONE CAN HEAR
ME OKAY BUT LET ME KNOW IF NOT.
THANK YOU SO MUCH FRANCIS FOR
LETTING ME UPDATE THE
SUBCOMMITTEE FROM THE CENTER FOR
GLOBAL HEALTH.
I WOULD BE BRIEF TODAY SINCE I
HAD THE OPPORTUNITY TO UPDATE
THE SUBCOMMITTEE WHEN WE MET
LAST AUGUST AND WANTED TO SAVE
TIME FOR OUR RPGHT SPEAKERS FOR
THE ENSUING DISCUSSION AT THE
END.
NEXT SLIDE, PLEASE.
SO LAST WEEK WAS A BUSY 1 FOR
THE NCI AND FOR CGH AS I'M SURE
ALL OF YOU ARE AWARE LAST
WEDNESDAY ON FEBRUARY 2nd AS
YOU MUST KNOW--CANCER THEME
WHICH WAS SIMILARLY MET WITH
VIBRANT WORLD WIDE ENGAGEMENT ON
SOCIAL MEDIA AND ELSEWHERE, WE
TOOK THIS OPPORTUNITY,
CANCER.GOV TO DESCRIBE SOME OF
OUR 2021 ACTIVITIES AND
HIGHLIGHTS AT CGH AND THOSE OF
YOU WHO CAN READ OUR STATEMENT
AND WORLD CANCER STATEMENT.
NEXT SLIDE, PLEASE.
--STRAY JECTORY TEENLIC PLAN
WHICH IS NOW PUBLICLY AVAILABLE
ON OUR WEBSITE WHICH WE
PRESENTED PREVIOUSLY TO THIS
GROUP WHICH WAS ACCOMPANIED BY A
JAMA PUBLICATION WE WROTE ABOUT
THE NEED TO PRIORITIZE CANCER IN
2021 WITH GLOBAL HEALTH WHICH
MAY HAVE BEEN SUFFICIENT IN 2011
WHEN CGH WAS ESTABLISHED BUT IT
IS NO LONGER SUFFICIENT GIVEN
THE CURRENT AND FUTURE
ANTICIPATED CANCER GLOBAL
BURDEN.
NEXT SLIDE, PLEASE.
IN RENEWING OUR VISION FOR THE
CENTER, WE REFOCUSED OUR EFFORTS
ON 4 PRIMARY GOAL AREAS WITH AN
EMPHASIS ON LOW AND MIDDLE
INCOME COUNTRIES, FOR CGH LED
PROGRAMS, WE AIM TO SUPPORT
RESEARCH THAT ADDRESSES THE
ISSUES IN GLOBAL CANCER CONTROL
OR LEVERAGES UNIQUE SCIENTIFIC
OPPORTUNITIES ARISING FOR GLOBAL
COLLABORATION, SUPPORTING GLOBAL
RESEARCH TRAINING, PROMOTE
SCIENCE DISSEMINATION FOR CANCER
CONTROL AND WE NEED TO LEVERAGE
GLOBAL PARTNERSHIPS WITH
GOVERNMENTAL AND NONGOVERNMENTAL
ORGANIZATIONS, WITHIN OUR
RESEARCH PROGRAM, WE'RE
CONCENTRATING ON SEVERAL APPLIED
AREAS SHOWN ON THIS SLIDE.
OUR FOCUS TODAY IS ON THE FIRST
OF THESE MAIN EFFORTS TO SUPPORT
INNOVATIVE AND CONTEXT
APPROPRIATE TECHNOLOGIES FOR
GLOBAL CANCER CONTROL, A MAIN
STAY OF THESE EFFORTS IS THE
AFFORDABLE CANCER TECHNOLOGIES
PROGRAM WHICH IS A TRANSNCI
PROGRAM THAT HAS BEEN ACTIVE
SINCE 2013, IN DECEMBER TWEBT 20
WEARY CEIVED APPROVAL FROM THE
BSA TO REISSUE THE PROGRAM IN
2021 EMPLOY OF NOTE THAT
APPROVAL WAS REQUIRED WITHOUT A
PRESENTATION WHICH WE REGUARDED
AS A TREMENDOUS VOTE OF
CONFIDENCE BUT ALSO A MISSED
TIEWNTD TO HIGHLIGHT THE
EXCITING PATIENT AND COMMUNITY
CENTERED DEVELOPMENT IN LMICs
THAT HAS BEEN ENABLED BY THE
PROGRAM WHICH WAS RECOGNIZED BY
AN NCI DIRECTOR'S AWARD IN 2021
IN WHICH WE HOPE TO HIGHLIGHT
THE SUBCOMMITTEE TODAY.
AS FRANCIS MENTIONED I WILL
REMIND SUBCOMMITTEE MEMBER AT
OUR LAST MEET NOTHING AUGUST,
DR. PATTY LED THE DISCUSSION
EMPHASIZING THE EXCITING CANCER
IMPLEMENTATION SCIENCE
OPPORTUNITIES WHICH EXIST IN
LMICs WHICH IS THE SECOND
RESEARCH AREA ON THIS SLIDE.
I WILL ALSO REMIND THE
SUBCOMMITTEE THAT IN 2021 WE
RECEIVED BSA APPROVAL FOR UR01
AND U51 CONCEPTS TO SUPPORT THIS
EMERGING FIELD.
WE LOOK FORWARD TO SHARING
PROGRESS AT FUTURE MEETING ABOUT
THESE NEW PROGRAMS AMOUNTED TO
LAUNCH IN 2022.
NEXT SLIDE, PLEASE.
FINALLY BEFORE HANDING OVER TO
DR. PEARMAN TO GIVE AN OVER VIEW
OFLET TECHNOLOGIES PROGRAM, I
WANT TO HIGHLIGHT SEVERAL
UPCOMES EVENTS AND ACTIVITIES
WHICH ARE LIKELY TO TRANSPIRE IN
THE INTERVAL BEFORE THE
SUBCOMMITTEE MEETS AGAIN.
AS MENTIONED WE ARE EXCITED TO
INITIATE U01 AND U54 PROGRAMS
LATER THIS YEAR.
WE ARE EXPANDING D43 GLOBAL
INSTITUTIONAL RESEARCH TRAINING
NETWORK WITH NEW AWARDS.
WE ARE CURRENTLY ANALYZING
RESPONSES FROM THE 2021 GLOBAL
ONCOLOGY SURVEY OF NCI
DESIGNATED CANCER CENTERS AND
LOOK FORWARD TO SHARING THESE
RESULTS SOON.
WE'RE PLANNING THE TENTH ANNUAL
SYMPOSIUM ON GLOBAL CANCER
RESEARCH VIRTUALLY IN MARCH WITH
THE ASCR, THE CONSORTIUM OF
UNIVERSITIES FOR GLOBAL HEALTH
AND SEVERAL NCI DESIGNATED
CANCER CENTERS, THE SYMPOSIUM
WILL HAVE EARLY INVESTIGATOR
CAREER DAY THIS YEAR FOR THE
FIRST TIME FOCUSED ON ASPIRING
GLOBAL CANCER RESEARCHERS.
IN 2022 GLOBAL CANCER RESEARCH
AND CONTROL SEMINAR SERIES,
GIVING TALKS INCLUDE
THANKSGIVING MORNING WHO TALKS
ABOUT FINANCIAL TOXICITY AFTER
CANCER AND LMICs AND I HOPE
SOME OF YOU WILL TUNE INTO SOME
OF THESE AND LOOK FORWARD TO OUR
PROGRESS IN THE DAYS AND MONTHS
TO COME.
THANK YOU FOR YOUR ATTENTION, IF
IT'S OKAY, I WILL HAND IT OVER
TO DR. PEARLANWHO'S SLIDES ARE
IMMEDIATELY AFTER MINE.
>> FANTASTIC.
>> THANKS SATISH.
>> I'M PAUL PEARLMAN AND I'M THE
PROGRAM DIRECTOR FOR GLOBAL
HEALTH TECHNOLOGY AND OVERSEE
THE TECHNOLOGY RESEARCH.
TODAY I'M HERE TO TALK ABOUT THE
AFFORDABLE CANCER TECHNOLOGIES
PROGRAM OR A. C. T.
NEXT SLIDE, PLEASE.
THE ACT PROGRAM SUPPORTS
TECHNOLOGY DEVELOPMENT FROM
PROTOTYPE STAGE THROUGH CLINICAL
IMPLEMENTATION STUDIES, ALL
THAT'S PROJECTS ARE EXPECTED TO
EXPLICITLY CONSIDER COST
AFFORDABILITY AND COST
EFFECTIVENESS IN LOCAL SETTINGS
AS WELL AS COST OF DISPOSABLES
AND REALITIES OF LOCAL SUPPLY
CHAINS.
INVESTIGATORS ARE REQUIRED TO
FOCUS ON PREVENTIBLE OR
TREATABLE CANCERS AND SPECIFIC
LMIC SETTINGS AND DEMONSTRATE
UTILITY OF THE PROPOSED
TECHNOLOGY TO IMPROVE CANCER
OUTCOMES.
THIS MAY OR MAY NOT--CLIENT OR
PATIENT INTERACTIONS AND COMPLEX
HEALTH SYSTEMS.
VALIDATION AND REAL WORLD HEALTH
SETTINGS ALSO OFTEN LEADS TO
ADDITIONAL ITERATIVE
INNOVATIONS, THE A. C. T.
PROGRAM FORMED A UNIQUE,
MULTIDISCIPLINEAR SKPE BAKUGAN
CROSS CULTURAL RESEARCH FOR
SIGNIFICANT CANCER CONTROL
CHALLENGES AND LMICs, THIS
ACTS AS RESEARCH PROGRAMS AT THE
NCLRKS I, ACTS FOCUSES ON
PROJECT WHERE IS THERE'S ALREADY
A WORKING PROTOTYPE WHETHER OR
NOT THIS TECHNOLOGY HAS YET BEEN
APPLIED TO A SPECIFIC CANCER,
THE ADAPTATION OF THAT DEVICE OR
ASSAY FOR A SPECIFIC CANCER AND
THE LMIC SETTING FOLLOWED BY
OPTIMIZATION OF THAT TECHNOLOGY
AND ITS INTENDED USE SETTING.
NEXT SLIDE.
SATISH MENTIONED, IT'S GOOD TO
NOTE THAT THIS PROGRAM IS A
TRANSNCI EFFORT THAT INCLUDES
PROGRAM EXPERTISE FROM ACROSS
THE NCI, THE NIBIB HAS
PARTICIPATED IN THE PROGRAM IN
THE PAST.
NEXT SLIDE.
ACTS LEVERAGES A NUMBER OF
PLATFORMS THAT ARE ENABLING A
NEW GENERATION OF CARE
TECHNOLOGIES TO ADDRESS LMICs
AND HEALTH SYSTEMS.
MANY OF THESE INNOVATIVE
TECHNOLOGIES SUCH AS LAB ON A
CHIP, LIQUID BIOPSY, NOVEL
IMAGES, MODALITIES AND IMAGE
ANALYSIS TOOLS, INCLUDING AI,
JUST TO MAIM A FEW HAVE
SIGNIFICANT POTENTIAL FOR IMPACT
IN LMICs, RECENT DEVELOPMENTS
AND CONSUMER ELECTRONICS, FIBRO
FABRICATION AND CELL PHONE
COMMUNICATIONS AND HAND HELD
COMPUTERS FURLGTER IMPROVE THE
PROSPECTS FOR SENSITIVE COST AND
PORTABLE TECHNOLOGIES FOR CANCER
CONTROL.
WE ALSO RECOGNIZE THAT NEEDS
OFTEN DRIVE OPPORTUNITIES FOR
ACCELERATED TECHNOLOGY
DEVELOPMENT.
SO FOR INSTANCE ISSUES AROUND
DISTANCE TO CARE AND CHAL
ERVELGS WITH FOLLOW UP MAY BE
MITIGATED IN PART BY TRUE POINT
OF NEED DETECTION AND DIAGNOSTIC
TECHNOLOGIES, UTILIZED AT THE
PATIENT OR COMMUNITY LEVEL.
MOLECULAR DIAGNOSTICS FOR
SPECIFIC CANCERS ON ONCOGENIC
VIRUSES AND TREATMENT MONITORING
MAY ALLOW LEAP FROGGING OVER
INFRASTRUCTURE WHERE APPROPRIATE
AND FINALLY TECHNOLOGIES MAY BE
ADDRESSED OR INTRODUCED TO
ADDRESS CRITICAL WORKFORCE
SHORTAGES BY SIMPLIFYING SAMPLE
PREP OR MAYBE LEVERAGES AI TO
AUTOMATE ROUTINE BURDENSOME
TASKS, SO MUSEUM HAN EFFORT IS
EXPENDED WHERE IT'S MOST NEEDED.
NEXT SLIDE.
THE ACTS PROGRAM SUPPORTS TEAM
SCIENCE PROJECTS THAT ARE
FOCUSED ON PREVENTING, DETECTING
AND DIAGNOSING TREATED CANCERS
IN LOCAL SYSTEMS THAT TAKES INTO
ACCOUNT THE COMPLEXITY OF THAT
HEALTH SYSTEM, OTHER DISEASE
PRIORITIES AND REAL WORLD
CONDITIONS, ACTS INVESTIGATORS
ARE EXPECTED TO TAKE END USER
DESIGN SERIOUSLY AS PART OF
THEIR PROJECTS, FOCUSING ON COST
AND,A FORDABLE BUT ALSO
USABILITY, CONTEXT OF USE AND
HOW THE INTERVENTION WILL
EVENTUALLY BE TAKEN UP IN LOCAL
COMMUNITIES.
GIVEN THESE COMPLEXITS IT'S
EXPECTED THAT ACTS EXPERTISE
BRING EXPERTISE FROM THE DOMAIN
ON ENGINEERING, ONCOLOGY PUBLIC
HEALTH AND IN MANY CASES THE
PRIVATE SEBLGHTOR TO BEAROT
CANCER CONTROL CHALLENGES THEY
SEEK TO ADDRESS.
NEXT SLIDE.
SO TO DATE THERE HAVE BEEN 3
FUNDED FOAs AND 21 PROJECTS
SUPPORTED IN THE ACTS PROGRAM.
ALTHOUGH SEVERAL CURRENT
PROJECTS ARE EXTENDED IN
ACCORDANCE WITH NIH
FLEXIBILITIES RELATED TO THE
GLOBAL PANDEMIC, THE LAST OF
THESE INVESTIGATORS WILL
EFFECTIVELY CLOSE OUT THEIR
PROJECTS IN APRIL OF 22, AT
WHICH TIME A NEW COHORT WILL
BEGIN THEIR PROJECTS.
MORE THAN A HUNDRED ACTS
PROJECTS HAVE BEEN INVITRO
ASSAYS, MORE THAN A THIRD HAS
BEEN FOR HIGHER QUAL TREATMENT
FOR CANCER AND A FEW
TECHNOLOGIES HAVE FOCUSED ON
PORTABLE IMAGING.
NEXT SLIDE.
BECAUSE OF THE TEAM SCIENCE AND
INTERNATIONAL NATURE OF THE
PROGRAM, WE BELIEVE ACTS HAS
HELPED PROVIDE NIH SUPPORT FOR
HIGHLY DIVERSE COMMUNITY OF
TECHNOLOGY FOCUSED
INVESTIGATORS.
ACTS KEY PERSONNEL UP IN 40%
WOMEN WITH 38% OF THE PIs
THEMSELVES BEING WOMEN, KEY
PERSONNEL ON THE GRANTS ARE
MAJORITY NONWHITE AND 32% OF
NONPIs BEING WHITE AND FINALLY
31% OF THE KEY PERSONNEL IN
GRANTS ARE LMICs, TO CONTINUE
BUILDING ON THESE EFFORTS IN
THE NEXT PHASE OF THE PROGRAM
AND IN LINE WITH BROADER NCI
EFFORTS TO DIVERSIFY THE
SCIENTIFIC WORKFORCE WE
EXPLICITLY REQUIRED THAT LMIC
PERSONNEL BE INCLUDED ON KEY
PERSONNEL ON FUTURE ACTS GRANTS,
ENCOURAGE USE OF THE MULTIT. I.
MECHANISM AND RARE SHARED PLANS
THAT DEMONSTRATE HIGH INCOME AND
LMIC INVESTIGATORS IN ALL
APPLICATIONS AND REALLY
IMPORTANTLY ESTABLISH IMPORTANT
CRITERIA TIED TO THESE
REQUIREMENTS.
NEXT SLIDE.
HAVE ABOUT BEEN SOME COMMON
THEMES FOR THE ACTS PROJECT
WHERE CANCER IS CONCERNED, NEW
COUNTRY EXPERIENCES HAVE LED TO
NEW DEVICES BETTER SUITED TO END
USER ENVIRONMENTS AND EXTENDED
ACTESS SOPHISTICATED OTHER
TARGETS.
LATER YOU WILL HEAR MORE ABOUT
THIS WHERE THE TINY PLATFORM IS
CONCERNED.
PROJECT TEAMS COMPETED FOR
ADDITIONAL FUNDING AND HELPED
LARGE MULTINATIONAL CONSORTIA
EXTENDING--IT'S ALSO IMPORTANT
TO NOTE THAT 2 ACTS
INVESTIGATORS GENERATED A KEY
PERSPECTIVE DATA FOR
THERMOCOAGULATION THAT WERE
INCORPORATED INTO THE 2019 W. H.
O. FOR CERVICAL TREATMENT OF
PRECANCKER.
DOE HAS SUPPORTED A LOT OF
SUPPORT FOR RADIOACTIVE THERAPY
PROJECTS AND USAID CREATED A
STAND ALONE PROJECT WITH NCI
SCALED INPUT TO ADDRESS CERVICAL
CANCER IN MALAWI AND MOZAMBIQUE
BASED PREVIOUS ON THE ACTS IN
THE PREVIOUS PROGRAM.
NEXT SLIDE.
THIS YEAR WE PUT OUT A PROGRAM
USING R21 MECHANISM IN CONTEXT
OF THE IMAT PROGRAM RFAs, THE
IMAT PROGRAM SPECIFICALLY
TARGETS HIGH RISK, HIGH REWARD
RESEARCH SO OUR GOAL WAS TO
ENRICH FUTURE ACTS INVESTIGATOR
POOLS WITH NEW APPROACHES,
SPECIFICALLY BY USING THIS
APPROACH, OUR GOAL IS TOUSHER IN
NEW AND INNOVATIVE PLATFORMS AND
THE ABILITY TO PROCESS MORE
COMPLEX SAMPLES AND START TO USE
THAT END USER DESIGNED INTO THE
EARLIEST STAGES OF DESIGN OF NEW
INTERVENTIONS, WE ALSO WORKED
CLOSELY WITH THE NCI SMALL
BUSINESS INNOVATION AND RESEARCH
DEVELOPMENT CENTER FOR SEVERAL
YEARS TO CREATE SEVERAL FUNDING
OPPORTUNITIES FOR GLOBALLY
DRIIVE HEALTH TECHNOLOGY
RESEARCH AND TO DATE 15 AWARDS
HAVE BEEN FUNDED TO THESESTS
WITHSTAND ALONE P As AND
APPLICATIONS CONTINUE TO COME IN
THIS RESPONSE TO A NOSI THAT HAS
THE SAME INTENT.
WE ARE ALSO LEVERAGING THE
CONTACT TOPIC MEMORY RESPONSE
NICKER TO FOCUS ON TOPICS SUCH
AS COMMERCIALLY DRIVEN POINT OF
DIAGNOSTICS TO SERVE THE BROADER
ELIMINATION GOALS, ALL OF THESE
HAVE ALLOWED FOR PHASE 1, AND
PHASE 2 AWARDS.
NEXT SLIDE.
FOLLOWING A FAVORABLE EXTERNAL
PROGRAM REVIEW AND ENTHUSIASTIC
SUPPORT FROM THE NCI LEADERSHIP
AND THE BSA, AT THE
DECEMBER 2020 JOINT BOARD
MEETING, WE WERE CERTAINLY
THRILLED TO REISSUE THE ACTS
PROGRAM LAST YEAR USING A U01
COOPERATIVE AGREEMENT MECHANISM.
THESE U01 GRANTS CONTINUE TO
SHARE THE FOCUS OF THE PREVIOUS
ACCESS FOAs BUT ARE A CLEAR
FOCUS ON CLINICAL VALIDATION AND
HEALTH SYSTEMS INTEGRATION WHILE
LEADING BUSINESS DEVELOPMENT
ASPECTS TO OTHER RELEVANT
INITIATIVES.
THE FIRST RFA IN THIS SERIES WAS
PUBLISHED LAST MARCH, EXPIRED IN
JUNE AND 7 NEW AWARDS WILL BE
ISSUED THIS SPRING.
WE EXPECT 2 SUBSEQUENT ANNUAL
ISSUANCES.
NEXT SLIDE.
NEXT SLIDE, PLEASE.
AT THIS POINT I WOULD LIKE TO
WELCOME OUR INVITED GUESTS WHO
CONDUCTED TRULY EXCITING WORK
THROUGH THE FIRST PHASE OF THE
ACTS PROGRAM--
>> PAUL?
>> YES, SIR.
>> IF YOU WOULD PERMIT ME, I
WOULD LIKE TO--BEFORE WE MOVE
OVER TO OUR GUESTS TO TAKE SOME
QUESTIONS SATISH AND YOU AND
THEN CLOSE THAT SECTION AND THEN
YOU GET BACK AND INTRODUCE THE
GUESTS, WOULD THAT WORK?
>> YES, SIR.
>> YEAH, OKAY.
SO THAT MAKES IT SMOOTH THEN.
I'LL OPEN THE MEETING NOW FOR
QUESTIONS TO DR. GOP A L'S
INITIAL PRESENTATION AND ALL TO
THE AFFORDABLE CANCER
TECHNOLOGIES PROGRAM OVERVIEW BY
DR. PEARLMAN, SO IF YOU HAVE ANY
QUESTIONS SPECIFICALLY TO THOSE
MORE GENERALIZED PRESENTATION,
WE CAN TAKE THEM NOW.
>> WELL I WILL START OFF WITH A
COMMENTARY ON THE--SA ATISH, YOU
DID MENTION THE GLOBAL HEALTH
CANCER SYMPOSIUM THAT YOU'RE
PLANNING AND I THINK YOU SAID
YOU WERE GOING TO ENGAGE OR YOU
ARE ENGAGED IN THE ACR,
ASCO-ACS, IN IT, I THINK IT'S
FANTASTIC BECAUSE AS YOU KNOW,
THEY HAVE VERY--ALL OF THEM ARE
ACTIVE ON A GLOBAL STAGE WITH
DIFFERENT PROGRAMS AND THE MORE
THOSE CAN BE LEVERAGED AND
INTERACTED WITH, THE MORE THAT
WOULD BE GREAT.
OH HERE'S A COMMENT.
TO DR. PEARLMAN, I'M WONDERING
HOW MANY OF THE TECHNOLOGIES,
THE APPS THAT HAVE BEEN FUNDED
THROUGH THIS PROGRAM HAVE MOVED
ON TO COMMERCIALIZATION OR AT
LEAST THE SBIR STAGE GIVEN A
SENSE HOW SUCCESSFUL IT'S BEEN?
>> WELL, THE SBIRs ARE
CERTAINLY RESTRICTED ONLY TO
U.S. SMALL BUSINESS INTEREST SO
IN MANY WAYS THE SBIR FUNDING TO
DATE HAS BEEN PARALLEL TO THE
PREVIOUS COOPERATIVE AGREEMENT
AWARDS THAT WERE FUNDED IN THE
ACTS PROGRAM, SOME--A COUPLE OF
THE INVESTIGATORS HAVE
SUCCESSFULLY SOUGHT SBIRs TO
FURTHER SOME OF THOSE
TECHNOLOGIES BUT THE
REALITY--INTO SORT OF COMMERCIAL
DEVELOPMENT OR MANUFACTURING.
I WOULD SAY THAT IF YOU'RE
LOOKING AT SORT OF BENCHMARKS
FOR COMMERCIAL SUCCESS, IT'S
LARGELY BEEN THE LICENSING OF
TECHNOLOGIES TO DATE WHICH IS
TRUE OF MANY OF THE
TECHNOLOGIES.
>> YOU HAVE A FEW OF THOSE?
>> YEAH, CERTAINLY MANY HAVE
BEEN LICENSED TO THEIR INITIAL
BUSINESS PARTNERS OR TO OTHER
COMPANIES.
>> I SEE, THAT'S INTERESTING.
ANY OTHER QUESTIONS OR COMMENTS?
>> HELLO, THIS IS
[INDISCERNIBLE] I'M FROM HOPKINS
I'M 1 OF NEW BOARD MEMBERS.
CANCER CENTERS HAVE INITIATIVES
IN THE GLOBAL HEALTH SPACE THAT
ARE BOTH, AT THE PILOT LEVEL OR
LARGER INITIATIVES THAT ARE DONE
IN COLLABORATION WITH SOME OF
THE--COUNTRYS ON THE OUTSIDE OR
OTHER INSTITUTIONS, IS THERE ANY
DISCREET STRUCTURE TO KNOW AND
KEEP TRACK OF PROJECTS THAT ARE
BEING DONE OUTSIDE OF NCI
FUNDING BUT THAT CAN INFORM NCI
PROJECTS?
BECAUSE MANY OF THOSE CAN BE
LARGE IN SCALE.
>> SATISH, YOU WANT TO TAKE THAT
ON?
>> YES, THANK YOU IF ARE YOUR
QUESTION, SO WE WORK VERY
CLOSELY WITH THE CANCER CENTERS,
TYPICALLY EVERY 2 YEARS WE
SURVEY THE CANCER CENTERS TO GET
A SENSE OF ALL OF THE ACTIVITY
YOU JUST ALLUDED TO, THAT IS
OCCURRING IN GLOBAL ONCOLOGY,
THE STUFF THAT IS NIH SUPPORTED
IS VERY EASY FOR US TO TRACK BUT
AS YOU KNOW MANY CANCERS ARE
DOING A LOT WITH PHILANTHROPIC
AND OTHER SUPPORT THAT IS LESS
EASY FOR US TO TRACK.
WE HAVE A REALLY GOOD SURVEY,
KIND OF INSTRUMENT THAT WE HONED
OVER MANY YEARS.
WE FIELDED IT LAST YEAR BUT
ESSENTIALLY A HUNDRED PERCENT
RESPONSE RATE FROM THE CANCER
CENTERS.
SO WE'RE IN THE PROCESS OF
ANALYZING AND DISSEMINATING THAT
INFORMATION NOW.
WE WILL LOOK FORWARD TO
REPORTING THAT OUT TO THIS GROUP
LATER THIS YEAR.
WITH THE LAST ROUND, WHEN WE DID
THAT WHICH WAS 2018/2019, ONCE
WE ANALYZED THOSE RESULTS,
THERE'S A PAPER ON JCO GLOBAL
SUMMARIZING THOSE RESULTS.
WE DISSEMINATED THEM QUITE
WIDELY INCLUDING TO THIS GROUP
TO ASCO, TO AACR, WE MADE A
PRESENT ANTICIPATION AT THE
CANCER CENTER DIRECTOR'S ANNUAL
MEETING, FOLLOWING WHICH MANY OF
THEM WANTED TO REACH OUT
SPECIFICALLY TO SPEAK ABOUT THE
GLOBAL ONCOLOGY PROGRAM SO WE
ARE LOOKING FORWARD TO HAVING
THOSE RESULTS FOR YOU LATE
THERAPY AND YEAR AND ALSO USING
THE DISSEMINATION AS AN
OPPORTUNITY TO REENGAGE WITH
CANCER CENTERS TO SPEZZIFY WE
CAN BETTER INCEND VISE AND
SUPPORT THESE KINDS OF EFFORTS.
>> RIGHT AND SATISH, YOU THINK
YOU CAN MAKE A NOTE TO CIRCULATE
TO MEMBERS OF THE SUBCOMMITTEE
THE JCR PUBLICATION?
>> SURE.
>> FRANK, COULD I ASK A QUICK
QUESTION.
>> SURE MARGARET.
>> TO DR. PEARLMAN, YOU
MENTIONED THERE WERE SEVERAL
INVITROW ASSAYS, I WAS WONDING
WHAT THEY WERE AND THEIR
RELEVANCE TO LMIC COUNTRIES,
SORRY.
JUST WONDERED ABOUT THAT.
>> SURE.
HAPPY TO RESPOND DR. SPITZ.
THEY RUN THE GAMUT ACROSS A
NUMBER OF CANCER TARGETS, THOUGH
CERTAINLY A LARGE PERCENTAGE OF
THEM HAVE FOCUSED ON HPV-RELATED
DIAGNOSTICS, GIVEN OUR ABILITY
TO ADDRESS CERVICAL CANCER AT
THE POINT OF NEED.
WE'VE ALSO HAD A NUMBER AND YOU
WILL HEAR ABOUT 1 OF THEM,
DIAGNOSTICS ASSOCIATED WITH HIV
ASSOCIATED CANCERS, SOME TOOLS
FOCUSED ON COLORECTAL CANCER
SCREENING, ESOPHAGEAL CANCER,
EARLY DETECTION AND WE HAD 1
DIAGNOSTIC TOOL THAT WAS FOCUSED
ON CML DIAGNOSTICS AND
MONITORING BUT THAT WAS 1
PARTICULARLY INTERESTING BECAUSE
IT WAS SORT OF LOW COST DIGITAL
PC R WHICH COULD BE USED FOR A
LOT OF OTHER THINGS.
SO LONG STORY SHORT, IT'S A WIDE
SPREAD BUT I THINK THE KEY TAKE
AWAY FOR THE ACTS PROGRAM PART
OF THE REVIEW CRITERIA IS THAT
THESE PROJECT VS TO FOCUS ON
PREVENTIBLE OR TREATABLE CANCERS
AT THE NEED OF SETTINGS WHERE
THE INVESTIGATORS ARE WORKING.
>> OKAY, THAT'S JUST WHAT I
WANTED TO HEAR, THANK YOU
DR. PEARLMAN NIF I'M NOT
MISTAKEN, I THINK ON THE WEBSITE
OF THE CENTER'S WEBSITE, THESE
ARE LISTED.
>> ABSOLUTELY.
SO WE PUT EFFORT INTO GENERATING
QUITE A LOT OF CONTENT ON THE
AFFORDABLE CANCER TECHNOLOGIES
WEBSITE AND I ENCOURAGE PEOPLE
WHO ARE INTERESTED TO TAKE A
LOOK.
>> THANK YOU.
>> ANY OTHER COMMENTS?
QUESTIONS?
WELL I SEE DR. SHARPLESS HAS
JOINED US AND THIS IS A PERFECT
TIME TO, NED SHARPLESS, TO MAKE
A FEW COMMENTS BEFORE WE
CONTINUE.
NED SHARPLESS?
>> I THINK YOU ARE HAVING A MIC
ISSUE?
>> I THINK HE IS MUTED.
CAN HE BE UNMUTED?
NHOW ABOUT NOW?
>> GREAT.
DID YOU HEAR MY COMEBTS?
>> SOMEBODY SAY SOMETHING, I
HAVE TO MAKE SURE I CAN HEAR YOU
NOW.
>> NED SHARPLESS, THIS IS
FRANCIS, CAN YOU HEAR ME.
>> I CAN HEAR YOU GREAT.
IN.
>> OKAY GREAT.
I SAID WELCOME AND COMING AT A
PERFECT TIME.
>> I'VE BEEN HAVING COMPUTER
DRAMA ALL DAY TODAY, IT'S THE
FIRST DAY BACK AT WORK AND THIS
COMPUTER WAS TROUBLE WHILE I WAS
GONE.
>> NED CAN'T HEAR US.
>> HE CAN BE THE HEAR YOU, SIR.
>> HE'S GOING TO LOG OFF AND LOG
BACK ON.
>> I WILL INTRODUCE THE SPEAKERS
AND THEN WE CAN HEAR FROM NED?
>> OKAY, ALL RIGHT.
>> PAUL?
>> GREAT, THANKS.
SO WE HAVE GUESTS HERE TODAY.
IF WE COULD MAYBE BRING UP MY
LAST SLIDE 1 MORE TIME WHOEVER'S
PILOTING IT.
SO TODAY WE HAVE DR. SAMIRI, WHO
WILL PRESENTOT ACTS SUPPORTED
PROJECT TITLED EARLY STAGE
DIAGNOSIS OF SARCOMA IN LIMITED
RESOURCE SETTING USING
KS-DETECT, HE IS JOINED BY DAVID
ERICKSON, SUBSEQUENTLY
DR. HANNAH SIM ONDS WILL PRESENT
ON A PLANNING ASSISTANT FOR
RADIATION PLANNING IN LMICs
AND SHE'S JOINED BY DR. LAWRENCE
COURT AND BETH BEAGLE FROM
STANFORD PERSPECTIVELY.
WE WERE HOPING TO SAVE QUESTIONS
AT THE END.
SO WITH NO FURTHER ADO I WANT TO
TURN IT OVER TO DR. SEMEERE.
>> CAN YOU HEAR US?
>> YES I CAN.
>> WONDERFUL.
>> GOOD MORNING TO YOU ALL.
THANK TO YOU THE ORGANIZERS FOR
GIVING ME THIS--AND THE TEAM
WITH THIS OPPORTUNITY TO SHARE
WHAT WE HAVE LEARNED FROM THIS
CHALLENGE OF KAPOSI SARCOMA WITH
MY COLLEAGUE DAVID ERICSON, JUST
TO GET THIS STARTED, THOSE WHO
ARE NOT FAMILIAR, KAPOSI SARCOMA
IS A CANCER ENDOTHELIAL CELL AND
IT AFFECTS MOSTLY THE SKIN,
MUCUS MEMBRANES AND SOMETIMES
DOES EXTEND TO THE LUNGS AND GI
TRACT.
IT IS CAUSED BY A VIRUS, IT'S
ASSOCIATED VIRUS ALSO IMOAZ AS
HERPES VIRUS 8, IT WAS IN THE
U.S. AND ALSO IN SUB-SAHARAN
AFRICA, BUT WHEN HIV EPIDEMIC IT
WAS BROUGHT TO THE FORE, AND YOU
KNOW BECAME PERMANENT AS 1 OF
THE POST DIAGNOSIS OF HIV AND
AIDS.
AND AS YOU KNOW HIV/AIDS HAS
BEEN TREATED WITH ANTIRETROVIRAL
THERAPY SO WHERE WE ARE NOW OUR
INTEREST IS GETTING PATIENTS
IMMUNE SYSTEMS NORMALIZED AND
SO, THE QUESTION IS WHAT'S THE
CURRENCE OF THIS CANCER IN A
NORMALIZED INDIVIDUAL.
WE DID LOOK AT THIS, AND FOUND
AN INCIDENCE OF 31 PER HUNDRED
THOUSAND OF COURSE THAT NUMBER
MEANS NOTHING UNTIL YOU PUT IT
IN CONTEXT.
BUT LOOKINGA THE VERY MOST
COMMON CANCERS FOR LOW INCOME
COUNTRIES, JUST DOWN THERE, CAN
YOU SEE THAT WITH AN INDENSE OF
31, PER HUNDRED THOUSAND AT THE
VERY TOP, IT'S NOT SOMETHING WE
CANNOT IGNORE AND ANOTHER IS THE
MORTALITY.
UP TO 40% OF OUR PATIENTS DIE
WITHIN A MONTH OF DIAGNOSIS AND
YOU CAN SEE THAT MOST OF THIS
DEATH HAPPENS WITHINLET FIRST 3
MONTHS OF DIAGNOSIS AND THIS IS
WHAT WE HAVE DONE IN EAST
AFRICA, DIAGNOSIS AS WOULD BE
SOCIAL SETTING WE TAKE A BIOPSY,
WITH PATHOLOGIC DIAGNOSIS THAT
LOOKS FOR SPINDLE CELLS,
INFLAMMATORY, AND ABNORMAL
VASCULATURE AND [INDISCERNIBLE]
WOULD GIVE US A TYPICAL
DIAGNOSIS BUT IN THE SOURCE
SETTING IN THE MEAN 2000S WHEN
WE LOOKED AT KS, PATIENTS WOULD
GET A BIOPSY BUT THIS TIME NOT
WITH A BUNCH BUT A WEDGE BIOPSY.
THOSE SURGEONS KNOW HA THAT THIS
IS A HERCULEAN TASK TO ORGANIZE
AND THAT MEANS THAT BIOPSY WAS
RARE.
LOOKING AT DATA FROM ZIMBABWE,
WE SAW FROM A STUDY THAT ONLY
23% OF 700 DIAGNOSIS WERE
POSITIVELY CONFIRMED AND IN OUR
WORK, JUST SHOWING 36% OUT OF
OVER 2439 VIRUSES PATH-CONFIRMED
BUT WITH GRAFTS THERE WAS A
TENDENCY IN THE COMMENTS AND OF
COURSE, THAT PATHOLOGY IS
IMPORTANT IF SOMEONE IS TO GET
TREATED.
BUT IF YOU CAN'T GET IT, WHAT
THEN HAPPENS?
SO TO TRY AND GET AROUND THIS
TOGETHER WITH SOME NIH FUNDING
AND WE THREW THE EAST AFRICA
IDEA, NCI DID HELP US START A
BIOPSY SERVICE WHERE WE TRAIN
[AUDIO CUTS OUT ]
THOUSAND 7 AND WITH THIS BIOPSY
COMING THROUGH ABOUT BUT THAT
WILL BE--WE HAD CHALLENGES WITH
TURN AROUND TIME AND AT 1 MONTH,
YOU KNOW ABOUT A THIRD OF OUR
PATIENTS, A THIRD OF OUR RESULTS
WERE NOT YET RETURNED TO THE
PATIENT AND YOU CAN SEE IN THIS
GRAPH THAT SOME OF THEM DIE
WITHIN A FEW WEEKS OF BIOPSY.
AND SO, THERE IS THE FACT THAT
WE HAD ACCURACY CHALLENGES.
WE DID COMPARE THE PATHOLOGY
READS FROM UGANDA AND KENYA TO
THOSE THAT 1 WOULD GET FROM THE
U.S. PATHOLOGIST AND WAS ONLY
[INDISCERNIBLE] IN 70% COMPARED
THIS.
SO THIS PICTURE NEEDED
SOMETHING, A BETTER WAY, AN
OPTION FOR US TO LOOK AT THIS.
SO WE WENT BACK TO THE CENTRAL
MARK THAT'S VIRUS IS A NECESSARY
CAUSE OF AGENT AND THIS IF WE
COULD USE THIS APPROACH, IT
WOULD HAVE AN IDEA OF TIMING
THIS INTO A LIQUID BIOPSY AND
EVEN AN INITIAL POINT OF CARE
PROCESS THAT REDUCES THE TIME TO
DIAGNOSIS, BUT IT CHALLENGE IS
THAT UP TO OVER 80% OF ADULTS IN
SUB-SAHARAN AFRICA ARE
KSHV-POSITIVE, AND SO SOMETHING
LIKE THIS, THE BIOPSY, COULD NOT
BE SPECIFIC.
SO THIS NEEDED TESTING.
AND WE JOINED EFFORTS WITH THE
TEAM AT CORNELL WHO WERE
ACTUALLY TESTING SOME PROTOTYPES
IN 2014, THEY BROUGHT THIS RED
BOX WE CALL IT, IT JUST USED
SOLAR AND WITH FEEDBACK WE
LOOKED AT [INDISCERNIBLE] AND
GIVE THEM FEEDBACK AND SHOWED
THEM WHERE THE CHALLENGES WERE
AND THEN THEY CAME UP WITH THE
BLACK BOX, THE BLACK BOX [AUDIO
CUTS OUT ] BUT STILL THERE WERE
ISSUES AND THINK IT COULDN'T BE
USED IN CERTAIN SETTING AND
FINALLY WE HAVE THE WHITE BOX
WHICH IS EVEN SMALLER AND THIS
IS NOW WHAT WE CALL THE TIEN O
ISOTHERMONUCLEOTIDES CLITIC
SYSTEM, IT CAN DO 6 TESTS, THAT
6 TIMES MULTIPLEXING AND
OPERATES ON BOTH ELECTRIC,
BATTERY AND SOLAR AND USES PHASE
CHANGE MEDIA TO MAINTAIN
CONSTANT TEMPERATURE.
AND BUILDING ON OUR PREVIOUS
PREBIOPSY PLATFORM, ALL WE
NEEDED TO DO NOW IS INSTEAD OF
JUST DOING 1 BIOPSY DISSECT IT
AND THEN 1 PART GOES TO THE
TYPICAL PATHWAY WHICH INFORMS
CLEAR, BUT THEN THERE IS--FOR
THE GOLD STANDARD TESTING, THEN
THE OTHER HALF GOES THROUGH THE
QUANTIFICATION OF NUCLEIC ACID
AND THIS WAS INITIALLY HAPPENING
AT CORNELL WHERE WE WOULD
EXTRACT DNA USING A QIAGEN KIT
AND RUNNING IT.
WHAT DID WE LEARN?
WE DID GET SENSITIVITY SO WHEN
WE COMPARE GOLD STANDARD
HISTOPATHOLOGY TO THE LAMP FOR
TIMING OF 500 PATIENTS WE GOT A
SPEC SPISSITY OF 93% AND A
SPECIFICITY OF 94% AND WE HAD A
WAY TO CLASSIFY ALMOST 96, WHERE
WE ARE, WE AGAIN ARE GOING BACK
AND BUILT ON TO AN NIH FUNDED
MECHANISM, THE U54 NETWORK TO
GET 9 CLINICAL SITES IN 6
COUNTRIES AND THIS IS IN UGANDA
WHERE WE'RE COORDINATING THIS
AND THAT'S WHERE WE INVEST IN
RWANDA, AGAIN IN KENYA,
TANZANIA, MALAWI, AND IN THIS
SITE WE ARE ACTIVELY ENROLLING
THROUGH HELP US VALIDATE THE
CURRENT DEVICE, SO SO FAR WE'VE
ENROLLED UP TO 700 PATIENTS OUT
OF 820.
OF COURSE THIS HAS BEEN SLOWED
DOWN OVER THE LAST 2 YEARS
BECAUSE OF WHAT EVERYBODY KNOWS,
THE COVID CHALLENGES BUT WE TILL
PROGRESS TO VALIDATE THIS AND TO
SHOW YOU HOW THE
MULTIDISCIPLINARY APPROACH THAT
WE REALLY NEEDED, WE NEEDED THE
ENGINEERS, DERMATOLOGISTS,
PATHOLOGISTS AND LARGE
EPIDEMIOLOGISTS, CLINICAL AND
CLINICIANS ACROSS DIFFERENT
PLACES AND DIFFERENT SITES TO
PULL THIS OFF.
SO, I WOULD BE ABLE TO--YOU KNOW
PRIOR LARGELY WE WERE--WITH THE
DIAGNOSIS FOR THAT CASE IN
SUB-SAHARAN AFRICA AND PATHOLOGY
DID PERFORM TURN AROUND AND
ACCURACY, BUT THIS QUANTITATIVE
OF CARE KSHV DNA DOES OFFER
PROMISE BECAUSE WE DEMONSTRATED
SENSITIVITY AND SPECIFICITY BUT
NOW WE NEED TO VALIDATE IT
ROBUSTLY AND THIS SUDDENLY WILL
BE RELEVANT FOR RESEARCH SETTING
AS WELL.
AND I THINK WE ENVISION A FUTURE
WHERE WE CAN HAVE AUTOMATED
MOLECULAR DIAGNOSIS FOR CARES AS
A STANDARD OPERATION IN ANY
SETTING.
THANK YOU VERY MUCH.
>> WONDERFUL.
THANK YOU.
PAUL, YOU INTRODUCED DR. SIMMONS
NOW.
>> YES, SIR.
>> IF YOU WANT TO DO BOTH AND GO
TO THE QUESTIONS, RIGHT?
>> YEAH, I THINK THAT WAY WE CAN
INCLUDE ALL OF THE OTHER GUESTS
AS WELL.
SO OUR NEXT TALK WILL BE FROM
DR. SIMMONS FROM [INDISCERNIBLE]
UNIVERSITY.
DR. SIMMONS?
>> GOOD EVENING, EVERYBODY FROM
SOUTH AFRICA.
THANK YOU VERY MUCH FROM THE
ADVISORY BOARD TO TALK TO YOU
TODAY.
OUR PROJECT IS THE RADIATION
PLANNING ASSISTANT, I'M JUST
WAITING IF ARE MY SLIDES, AND
THIS IS AN AUTOMATED RADIATION
PLANNING TECHNOLOGY, THAT'S BEEN
DEVELOPED FOR LOW AND MIDDLE
INCOME COUNTRIES AND IS THE
BRAIN CHILD OF DR. COURT AND
DR. BEAGLE.
NEXT SLIDE, PLEASE.
SO RADIATION RESOURCES IN AFRICA
IS A REAL CHALLENGE, AS OF
MARCH 2020 OR 50% OF AFRICAN
COUNTRIES HAD ACCESS AND LESS
THAN 40% HAVE ACCESS TO BREAKY
THERAPY WHICH IS CRITICAL TO
SURVIVAL CANCER AND NO COUNTRY
IN AFRICA HAS THE CAPACITY TO
MEET THE ESTIMATED NEED,
ACCEPTABLE PRACTICE ESTABLISHED
BY THE IAAIS 1 MACHINE PER
250,000 POPULATION AND NOT A
SINGLE POPULATION IN AFRICA CAN
ACHIEVE THIS.
AND THIRD 50% OF ALL RESOURCES
ARE ISOLATED IN THE NORTH AND
SOUTH OF AFRICA AND CENTRAL
AFRICA IS VERY MUCH IN NEED.
NEXT SLIDE, PLEASE.
BUT HARDWARE IS NOT ALL THE
PROBLEM.
WE HAVE A BIG ISSUE WITH TRAINED
PERSONNEL SO CLINICAL ONCOLOGY
SHOT FULL IS A WORLD WIDE ISSUE
WITH 8 COUNTRIES IN THE WORLD
HAVING NO CLINICAL ONCOLOGIST AT
ALL AND MOST OF THOSE COUNTRIES
IN AFRICA, 27 COUNTRY VS A
CLINICAL ONCOLOGIST ONLY FOR 1
ONCOLOGIST FOR EVERY 23,000
CASES BUT NOT ONLY DO WE HAVE A
SHORTAGE OF MEDICAL ONCOLOGISTS
BUT WE HAVE A SHORTAGE OF
RADIATION SPECIALISTS AND
MEDICAL SPECIALISTS SO IN MY
SECTOR I HAVE TO SIGN OFF AND
PLAN FOR MORE THAN 400 PLANS A
YEAR BUT MY COLLEAGUES HAVE TO
DO 2000 CASES A YEAR.
NEXT SLIDE, PLEASE.
SO RADIO THERAPY IS COMPLEX ON
MANY LEVELS, NOT ONLY FROM A
TECHNOLOGY AND A HARDWARE POINT
OF VIEW BUT NEEDS MULTIPLE
TRAINED PERSONNEL.
NEXT SLIDE.
AND SO THERE'S GREAT POTENTIAL
FOR AUTOMATION IN ALL OF THESE
STEPS.
NEXT SLIDE, PLEASE.
AND WHAT HAS BEEN FOUND IS THAT
NEARLY 60-70% OF ALL RADIATION
PROCESSES COULD BE USED,
AUTOMATED AND AI COULD BE USED,
FIRST OF ALL AUTOMATED, AND
PLANNING TASKS FOR THE M. D. AND
THEN TO PRODUCE HIGH QUALITY
PLANS AND CONTROLS WHICH
INCREASES CONSISTENCY AND
REDUCED EDITS AND
[INDISCERNIBLE] SO THE POETIC
TEBTIAL IMPACT FOR US IN THE
LMICs IT COULD ASSIST IN THIS
HUGE OVERWHELMING WORKFORCE
CHALLENGE THAT WE HAVE, THEREBY
REDUCING TASKS FOR ALL INVOLVED.
IT COULD ALSO REDUCE OBSERVE
VARIABILITY BECAUSE THE SKILLS
MIXED ACROSS THE CONTINENT IS
QUITE VARIABLE AND THE RPA HAS
THE POTENTIAL TO ASSIST SKILLS
IN NEW OR LIMITED AND WHETHER
THEY'RE JUNIOR, STAFF ARE IN
CHARGE OF THE DEPARTMENTS AND IT
CAN ALSO AND MOST IMPORTANTLY
INCREASE SAFETY BY REDUCTION OF
HUMAN ERROR OPPORTUNITIES.
THE CHALLENGE IS FOR ALL OF US,
OUR STAFF, RESPONSES, MY OWN
STAFF HAVE CONCERNED ABOUT
FEELINGS OF THEIR OWN VALUE,
LACK OF RECOGNITION OF THEIR OWN
EXPERTISE AND WITH ALL OF US WE
HAVE A FEAR OF THE UNKNOWN AND
POTENTIALLY COULD REDUCE
OPPORTUNITY FOR TRAINING FOR
RADIOLOGY STUDENTS AND ONCOLOGY
AND THE RESOURCE REQUIREMENTS
ARE SIGNIFICANT.
IT REQUIRES CT PLANNING
HARDWARE, MANY CENTERS CT
SCANNERS ARE OFFSITE, WE NEED
SOFTWARE CAPABILITIES AND 3D
IMAGES, HERE, ASK REQUIRES I.T.
INFRASTRUCTURE, SUPPORT AND
SERVICE AND THE 1 THING WE DO
KNOW IN AFRICA WE STRUGGLE TO
ACHIEVE STABLE INTERNET AND OF
COURSE THE BIG FACTOR IS COST.
NEXT SLIDE, PLEASE.
>> SO THE RPA GOALS ARE REALLY
DESIGNED FOR SCALABILITY, WEB OF
HAD BASED SOLUTIONS HAVE BEEN
WORKED ON AND THE MAIN BENEFIT
OF A WEB BASED SOLUTION IS EASY
UPGREAT AND PROMOTE MAINTENANCE
AND ALSO THE HUGE CAPACITY TO
PLAN MORE THAN A HUNDRED
THOUSAND PATIENTS PER YEAR.
NEXT SLIDE, PLEASE.
>> SO THE RPA IS BEING DEVELOPED
WITH THE ABILITY TO DO MULTIPLE
TASKS, FIRSTLY THE ABILITY TO
ORDER CONTROL, NORMAL TISSUES
AND TARGETS IS NOW COMPLETE.
NEXT SLIDE.
ABILITY TO AUTOMATICALLY
GENERATE HIGH QUALITY RATED
THERAPY PLAN SYSTEM WELL ON THE
WAY TO BEING COMPLETE.
SIMPLE PLANS OF 2 D RADIO
THERAPY WHICH CAN BE USED IN
MANY CENTERS IN AFFRIC A3D RATED
THERAPY WHICH CAN BE USED IN
SOME AND THOSE OF US THAT ARE
LUCKY TO HAVE HIGH-TECHNOLOGY
WITH ROTATIONAL THERAPY, IT HAS
THE ABILITY TO GENERATE VMAT
PLANS.
NEXT SLIDE, PLEASE.
AND MOST IMPORTANTLY AS WE
DISCUSSED IT CAN AUTOMATICALLY
ASSURE QUALITY AND IDENTIFY
POTENTIAL FAILURES.
BECAUSE QUALITY INTERPERENSEL OF
BOTH CONTROLS AND PLANS IS
ESSENTIAL FOR PATIENT SAFETY AND
ALL AUTOMATED TASKS ARE REPEATED
WITH AN INDEPENDENT ALGORITHM IN
THE RPA AND OUTLIES A FLAG FOR
THE USER AND EACH IMPORTANT STEP
OF THE WAY, IT WILL BE SIGNED
OFF BY A CLINICIAN.
NEXT SLIDE, PLEASE.
SO THE CURRENT STATUS OF THE RPA
IS DEVELOPED FOR MULTIPLE CANCER
SITES, NOVEL APPROACHES
AND DIFFERENT
PARADIGMS, IT'S BEEN DEVELOPED
WITH SOLUTIONS BASED ON LOCAL
PRACTICE FROM DIFFERENT LMIC
CENTERS, OUR OWN PATIENTS OFTEN
HAVE ADVANCED LARGE TUMORS AND
CLINICAL TEAMS AND SKILLS AND
NEEDS.
IT'S GONE THROUGH COMPREHENSIVE
CLINICAL ACCEPTABILITY TESTING,
31 RADIATION ONCOLOGISTS, TEN
INSTITUTIONS, 75 PATIENTS PER
SITE, OVER 8,000 RATINGS.
THIS INCLUSION OF THOSE RATINGS
OVERALL BETWEEN 90 AND 100% OF
RGA GENERATED TUMORS AND
CONTOURS USED WITH NO EDITS, OR
SOME MINOR EDITS WHICH MAKE TAKE
TEN MINUTES.
THE OTHER IS THE RESEARCH
OUTPUTS, VERY SUCCESSFUL
DIRECTLY FROM THE UH2 AND UH3
OUTPUT, TEN PAPERS IN HIGH
QUALITY JOURNALS, FIFTEEN
PAPERS.
NEXT SLIDE PLEASE.
FUTURE PLANS FOR THE RPA, IN OUR
WAY FORWARD, CURRENTLY RPA IS
WAITING FOR OUTCOME OF THE FDA,
TO BE APPROVED FOR CLINICAL USE,
THAT'S EXPECTED -- THAT RESULT
IS EXPECTED IN FEBRUARY, THE
PLAN TO TRY TO DEPLOY CLINICALLY
IN SOUTH AFRICA LATER ON THIS
YEAR, AND TO SCALE UP TO OTHER
LMICs WHILE SEEKING ADDITIONAL
FUNDING SUPPORT.
THE FUTURE PRACTICAL BENEFITS
DIRECTIONS FOR MAXIMUM BENEFIT
IS TO TRY TO INTEGRATE THE RPA
TO IMPROVE CLINICAL WORK FLOW,
LMIC STAFF NEED TO UNDERSTAND
PLANNING PROCESSES AND NEED
SKILLS.
EDUCATION WILL BE KEY BECAUSE WE
ALL NEED ABILITY TO CRITICALLY
APPRAISE RPA-GENERATED CONTOURS
AND PLANS.
WE NEED TO IDENTIFY PROS AND
CONS OF WEB BASED SOLUTIONS FOR
CENTERS, WE HAVE ALL VARIABLE
INTERNET, THE MAIN GOAL TO
IDENTIFY LONG-TERM SOLUTIONS TO
THE RPA INFRASTRUCTURE AND TO
MAINTAIN SUSTAINABILITY.
NEXT SLIDE PLEASE.
I WOULD LIKE TO THANK YOU FOR
YOUR TIME.
WE WELCOME ANY QUESTIONS.
THANK YOU VERY MUCH.
>> THANK YOU.
SO, THE TWO PRESENTATIONS ARE
OPEN FOR DISCUSSION.
>> I WOULD ALSO LIKE TO INVITE
ALL OF OUR GUESTS TO TURN ON
THEIR CAMERAS AND JOIN THE
DISCUSSION PLEASE.
>> YES, MARGARET?
>> FIRST OF ALL, DR. SIMMONS,
IT'S WONDERFUL TO SPEAK TO
SOMEONE WHO IS LIVING AND
WORKING IN THE COUNTRY OF MY
BIRTH, THAT I MISS VERY MUCH.
NUMBER TWO, I WAS JUST
WONDERING, YOU DID REFER TO IT
IN YOUR VERY LAST ONE OF THE
BULLETS, OF YOUR LAST SLIDE, THE
ISSUE IN SOUTH AFRICA, I HAVEN'T
BEEN BACK IN A LONG TIME BUT I
IMAGINE IT'S VERY DIFFERENT FROM
THE REST OF AFRICA, OR MOST
AFRICAN COUNTRIES IN TERMS OF
INTERNET ACCESS, HARDWARE,
SOFTWARE, EXPERTISE OF STAFF, SO
ON, WHERE THE PROGRAM SOUNDS
FANTASTIC AND WOULD BE A GREAT
ADDITION TO YOUR ARSENAL BUT I'M
WONDERING HOW MANY COUNTRIES ARE
AT A LEVEL THAT IT COULD BE
APPLIED WITH AS WELL WITHIN THE
AFRICAN CONTINENT?
>> SO, IN THE PUBLIC SECTOR IN
SOUTH AFRICA PROBABLY AS WELL
RESOURCED WITH HUMAN CAPITAL AS
WE WOULD LIKE TO BE, WITH ONLY
40 ONCOLOGISTS TRYING TO DELIVER
CARE FOR 85% OF THE POPULATION,
BUT A LOT OF WORK HAS GONE INTO
ASKING EXACTLY THAT QUESTION SO
WE'RE WORKING WITH OUR
COLLEAGUES ACROSS THE CONTINENT
TO SAY WHAT ARE YOUR CHALLENGES,
WHAT ARE YOUR INFRASTRUCTURE
CHALLENGES, WHERE IS YOUR CT
SCANNER, WHAT TYPE OF
RADIOTHERAPY MACHINES DO YOU
HAVE?
SOMEHOW WE MAY WORK TOWARDS
TRYING TO MAKE THIS ACCESSIBLE
TO COBALT USERS, THOUGH COBALT
IS MUCH LESS USED ON THE
CONTINENT NOW.
IS ALMOST BEING PHASED OUT.
SO IT'S PART OF WHAT IS BEING
LOOKED AT, WHAT ARE THE REAL
CHALLENGES, HOW CAN WE WORK
AROUND THEM, WITH A MIXTURE
BETWEEN ON-SITE APR HARDWARE
STRUCTURE AND REMOTE STRUCTURE
FOR THOSE THAT HAVE ACCESS TO
INTERNET.
YOU WOULD BE SURPRISED HOW MANY
IN THE CONTINENT, PARTICULARLY
IN THE LAST TEN YEARS, REALLY
SCALED UP INFRASTRUCTURE WITH A
LOT OF FUNDING FROM
INTERNATIONAL FUNDERS, IAA,
THEIR OWN GOVERNMENTS
UNDERSTANDING CANCER NEEDS TO
GET ON THE AGENDA.
>> THANK YOU.
>> WE HAVE FOUND THAT A LOT OF
GOVERNMENT PHILANTHROPIC
ORGANIZATIONS SPONSORED PURCHASE
AND INTEGRATE OF LINEAR
ACCELERATORS BUT DO NOT HAVE THE
SKILL SET TO KEEP THEM RUNNING
OR PLAN THE PATIENTS, THAT
INVESTMENT IS LARGELY WASTED,
REALLY UNFORTUNATE TO SEE
BUNKERS WITH LINEAR ACCELERATORS
EITHER NOT FULLY DEPLOYED OR
UTILIZED, DUE TO LACK OF
PERSONNEL AND TRAINED STAFF.
SO WE REALLY HOPE WE CAN
CAPITALIZE ON THOSE INVESTMENTS
AND MAKE THEM ACTUALLY
MEANINGFUL TO PATIENTS
THROUGHOUT THE CONTINENT AND
THROUGHOUT THE WORLD.
>> TO FOLLOW UP ON THAT, DR.
SIMMONS, YOU DID MENTION YOU'RE
WAITING FOR FDA APPROVAL.
IS THAT SOUTH AFRICAN FDA OR
U.S. FDA?
THE FIRST QUESTION, LET ME ASK
MY NEXT QUESTION, YOU CAN
ADDRESS BOTH.
AND THE NEXT PHASE, WHEN YOU DO
A LARGER SCALE CLINICAL TESTING,
DO YOU PLAN TO -- MARGARET'S
QUESTION, TO DO SOME -- INCLUDE
SOME CENTERS OUTSIDE OF SOUTH
AFRICA?
>> SO, THE FIRST QUESTION ABOUT
THE FDA IS THAT IT'S U.S. FDA,
BUT DR. CORK WILL SPEAK MORE
ABOUT THAT.
OUR OWN RULES FOR IMPLEMENTATION
SOUTH AFRICA MAY DIFFER THAN THE
FDA OBLIGATIONS.
AND YES, DR. CORK WILL WORK WITH
MANY PEOPLE ACROSS THE
CONTINENT, THE PLAN TO BE
DEPLOYED TO OTHER COUNTRIES WITH
THE MINIMUM INFRASTRUCTURE
NEEDED, REAL STAFF ARE BEYOND
THE NORTH AND SOUTH.
IT'S EAST, WEST, MIDDLE THAT
REALLY NEED RPA-TYPE TECHNOLOGY
TO BE SUCCESSFUL TREATING THEIR
PATIENTS.
>> I CAN SAY SOMETHING ABOUT THE
FDA.
SO IT'S -- WE'RE GOING THROUGH
THE FDA, THE AMERICAN FDA, BUT
THE REAL REASON IS TO GIVE US
CREDIBILITY AND IT SHOWS THAT WE
HAVE LIKE THE RISK MANAGEMENT,
QUALITY MANAGEMENT, ALL OF
THOSE, SOFTWARE LIFE CYCLE, ALL
THOSE PROCESSES THAT YOU NEED TO
CREATE THE SOFTWARE DEVICE FOR
MEDICAL USE SHOWS WE HAVE THEM
IN PLACE, SO IT SHOWS PEOPLE,
ALSO MAKES SURE WE DO HAVE THEM
IN PLACE.
IN TERMS OF SOUTH AFRICA, WE
HAVE ALL THE LEGAL -- WE'VE HAD
CONSULTANTS HELP US WITH THE
LEGAL, WE'RE IN PRETTY GOOD
POSITION FOR SOUTH AFRICA, AND
OUR GOAL IS TO TREAT IN SOUTH
AFRICA AT THE END OF THIS YEAR,
AS DR.SIMMONS SAID, AND WHEN
PEOPLE USE THIS CLINICALLY CAN
PAY A CAREFUL LOOK AT WHAT RISKS
AND HOW PEOPLE USE IT, THAT WE
HAVEN'T -- WE DON'T KNOW YET,
THE IDEA IS TO SCALE BASED ON
THAT EXPERIENCE.
YEAH, ABSOLUTELY WE'LL BE
SCALING ELSEWHERE AS WELL.
>> ANY OTHER QUESTIONS?
WELL, LET ME THEN -- DR. SAMIR,
VERY INTERESTING PRESENTATION.
I HAVE TWO QUESTIONS.
YOU DID MENTION THAT YOU ARE
ALSO -- IN ADDITION TO PUNCH
BIOPSIES GOING TO USE LIQUID
BIOPSIES.
I WONDER WHAT TYPE OF LIQUID
BIOPSY AND WHAT MARKER?
IS IT TO LOOK FOR THE VIRUS OR
SOME OTHER BIOMARKER?
>> YES, SO THE LIQUID BIOPSY
IDEA IS -- YOU CAN THINK ABOUT
IT TWO WAYS.
FIRST, THE --
[AUDIO DISTORTION]
THE RNA, SORT OF --
[AUDIO DISTORTION]
BUT THAT'S --
[AUDIO DISTORTION]
YEAH, THAT'S I THINK THE IDEA
THAT WE WERE TRYING TO PUSH
ALONG WITH THIS, SO IT'S --
[AUDIO DISTORTION]
>> OKAY.
QUICKLY, TINY, THE INSTRUMENT,
WHAT'S THE READOUT YOU HAVE?
QUANTITATIVE OR QUALITATIVE?
YES OR NO?
>> QUANTITATIVE READ.
AND WE NEEDED THAT TO ENABLE
US -- YOU KNOW, DEVELOP THE
CUT-POINTS OF THE QUALITATIVE.
MY COLLEAGUE, DAVID, IS THE
BETTER ENGINEER AT THIS AND HE
MAY BE ABLE TO ARTICULATE IN
MORE SPECIFIC TERMS THAN ME.
DAVID, DO YOU WANT TO SAY
SOMETHING?
>> YEP.
EXCUSE ME, YEP.
WE-- IT IS QUANTITATIVE, THE
RESULT IS QUANTITATIVE, AND WE
USE THAT QUANTITATIVE RESULT,
SORT OF AMOUNT OF DNA IN THE
BIOPSY TO SET CUT-POINTS ABOVE
WHICH WE CAN CALL IT CANCER AND
BELOW WHICH WE CAN CALL IT NOT
CANCER.
>> OKAY.
ANY OTHER QUESTIONS?
WELL, THAT'S VERY FASCINATING,
TWO EXCELLENT EXAMPLES OF WHAT
THE AFFORDABLE CANCER
TECHNOLOGIES PROGRAM CAN DO.
AND AT THIS JUNCTURE, NED, ARE
YOU STILL ON?
DR. SHARPLESS?
I THINK HE HAS COMPUTER
PROBLEMS.
>> I HOPE HE CAN FIX HIS
COMPUTER ISSUE BEFORE THE
AFTERNOON.
>> YEAH.
OKAY.
WELL, THE -- SO ANY CLOSING
COMMENTS, SATISH?
>> NO, IT'S GREAT TO ALWAYS
INTERACT WITH THE SUBCOMMITTEE
AND THANKS FOR THE OPPORTUNITY
TO HIGHLIGHT SOME OF THE WORK
THE AFFORDABLE CANCER
TECHNOLOGIES PROGRAM HAS
SUPPORTED.
>> WELL, WE'RE RIGHT ON 12:45,
RIGHT ON TIME.
AND I THINK WITH THAT WE WILL
ADJOURN.
AND THANK YOU ALL FOR COMING.
>> NCAB SUBCOMMITTEE MEETING HAS
CONCLUDED.
WE'LL NOW TRANSITION TO THE NCAB
OPEN SESSION THAT WILL BEGIN AT
ONE P.M. ON SEPARATE VIDEOCAST.
THIS VIDEOCAST SESSION WILL NOW
END.