>> 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. >> 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.