>> WELCOME TO THE COMMITTEE MEMBERS, STAFF AND GUEST. AS COMMITTEE MEMBERS YOU MUST ABSENT YOURSELF DURING SPECIFIC DISCUSSIONS WHEN YOUR PARTICIPATION AND DELIBERATIONS OF A PARTICULAR PRODUCT, PROGRAM OR OTHER SPECIFIC MATTER COULD CONSTITUTE A CONFLICT OF INTEREST AND APPEAR TO HAVE ONE AND ABSTAIN FROM ANY PARTICIPATION IN THE DISCUSSION OR ACTION REGARDING THAT MATTER. IN KEEPING WITH GOVERNING POLICY BASED ON FINANCIAL HOLDINGS OF SPECIAL EMPLOYEES WHICH INCLUDES ALL CATEGORIES OF THIS COMMITTEE WE MUST ASK TO YOU VOLUNTARILY ABSENT YOURSELF DURING ALL DISCUSSIONS OF MATTERS THAT CAN CONCEIVABLY IMPACT THE STATUS OF YOUR HOLDING. WE TRUST YOUR JUDGMENT IN THESE INSTANCES. MEMBERS OF THE PUBLIC WHO WISH TO EXPRESS VIEWS REGARDING ANY ITEMS DISCUSSED DURING THE MEETING MAY DO SO BY WRITING TO THE EXECUTIVE SECRETARY OF THE COMMITTEE WITHIN 10 DAYS AFTER THE MEETING ANY WRITTEN STATEMENTS WILL RECEIVE CAREFUL CONSIDERATION. BY LAW, A QUORUM OF COMMITTEE MEMBERS IS REQUIRED FOR EACH INSTANCE IN WHICH A VOTE OCCUR. DURING TODAY'S MEETING A MINIMUM OF SEVEN APPOINTED MEMBERS MUST BE PRESENT SO YOUR PRESENCE IS A MUST FOR ALL SEGMENTS OF THE MEETING. KAREN, DO WE HAVE A QUORUM? >> WE DO. I'VE ALL RECEIVED COPIES OF THE MEETING. I'D LIKE TO ASK FOR A MOTION TO APPROVE THE MINUTES. >> SO MOVED. >> SECOND. >> THANK YOU. ANY DISCUSSION OF THE MINUTES? >> NO. >> THANK YOU, RAY. IF THERE'S NO FURTHER DISCUSSION, CAN WE HAVE A VOTE AND I SUGGEST IF NING IS OPPOSED TO APPROVING THE MINUTES YOU SO INDICATE. THE MINUTES ARE APPROVED. THERE'S A LIST OF CONFIRMED FUTURE MEETING DATES ON THE AGENDA YOU CAN EXAMINE. OUR NEXT MEETING WILL BE ANOTHER VIRTUAL MEETING ON FEBRUARY 23, 2021. LOSE MARK YOUR CALENDARS ACCORDINGLY. -- PLEASE MARK YOUR CALENDARS. FIRST IS THE REPORT FROM DIRECTOR SHARPLESS. OVER TO YOU. >> THANK YOU. IT'S GOOD TO SEE EVERYONE VIRTUALLY. THANK YOU FOR JOINING US TODAY. A LOT TO CATCH UP ON FNLAC. I WAS TOLD WE'D BE JOINED BY DENISE MONTEL. I DON'T THINK I SEE HER ON THE LIST? OKAY. THERE SAY REPRESENTATIVE FROM THE -- IS A REPRESENTATIVE FROM FNLAC AND I'LL REPRESENTER IN THE FUTURE. I'LL PROVIDE AN UPDATE OF OUR FISCAL SITUATION AND ACTIVITIES RELATED TO COVID AND THOSE RELATED TO FREDERICK LAB AND AN EXAMPLE OF OUR RAPID PROGRESS IN CANCER OUTCOMES. I'LL FINISH UP TALKING A LITTLE BIT ABOUT THE 50th ANNIVERSARY OF THE NATIONAL CANCER ACT SO LET'S START WITH OUR BASE APPROPRIATION AS IS MY TRADITIONAL WE TALK ABOUT WHERE WE ARE IN THE BUDGET. WE TALKED ABOUT THE GOINGS ON OF CONGRESS. IT'S BEEN AN INTERESTING YEAR. APPROPRIATIONS IS A FUNNY BUSINESS AND THIS YEAR IS LIKE NO OTHER BECAUSE OF THE PANDEMIC. SUFFICE TO SAY WE HAD FOUR SUPPLEMENTAL PACKAGES PASSED IN RAPID SUCCESSION. THE FOURTH INCLUDED FUNDS FOR NCI RELATED SEROLOGY TESTING. THERE'S BEEN CONSTANT DISCUSSION OF A FIFTH SUPPLEMENT WHICH HAS NOT COME TO PASS THOUGH THE LIKELIHOOD OF THAT OCCURRING SEEMS TO HAPPEN HOURLY. IT MAY INCLUDE SUPPORT FOR NIH AND NCI. WE'RE CAREFULLY MONITORING THAT. THE OVER ARCHING HISTORY OF FUNDING FOR NCI SINCE 2015 THE NATIONAL CANCER'S ENJOYED AN INCREASE DO OUR BASE APPROPRIATION EVERY YEAR AND IN THE COLORED THE ORANGE REPRESENTS THE 21st CURES MOON SHOT AND GREEN SHOWED THE CHILDHOOD CANCER INITIATIVE STARTING 2020. ALSO 2020 WE GOT A SUPPLEMENT FOR SEROLOGY A SEPARATE SET OF MONEY TO DO COVID RESEARCH AND THE 2021 MARK FROM THE HOUSE PASSED MONTHS AGO AND I'M NOT SURE IS RELEVANT TO THE CONVERSATION OF FUTURE APPROPRIATIONS ANY LONGER BUT THERE WAS $414 MILLION OF EMERGENCY FUNDING TO THE NATIONAL CANCER INSTITUTE USED TO ADDRESS THE PROBLEMS CAUSED IN CANCER RESEARCH BY THE PANDEMIC. THE SUPPLEMENT INCLUDES THE FUNDING POSSIBLY FOR THE NCI. THIS IS IMPORTANT AS WE EXPECT EIGHT OF COST IN FY21 FROM THE PANDEMIC RELATED TO CANCER RESEARCH. WE'RE EAGERLY WAITING FOR RESOLUTION OF THIS TOPIC. I WANTED TO TALK A LITTLE BIT ABOUT SEROLOGY WORK THAT SUPPLEMENTAL FUNDING PROVIDED FOR THE NCI AND HERE'S A LIST OF SOME ACTIVITIES THAT WE HAVE TAKEN ON RELATED TO COVID RESEARCH AND THIS IS NOT COMPREHENSIVE BUT SOME OF THE MORE VISIBLE THINGS WE'VE BEEN DOING PARTICULARLY IN FREDERICK. I'LL TELL YOU MORE ABOUT A LARGE FUNDING INITIATIVE THAT INVOLVES FREDERICK NATIONAL LAB. THERE'S BEEN AN EXTENSIVE SET OF STUDIES WORKING WITH THE FDA TO VALIDATE THE COMMERCIALLY AVAILABLE SEROLOGY PRODUCTS AND THE NCI SERVED AS A REFERENCE LAB, IF YOU WILL TO VALIDATE ASSAYS NOR FDA SINCE THEY'VE BEEN -- FOR FDA SINCE THEY'VE BEEN CLEARING AND HELP PROVIDE THE ASSESSES THE FREDERICK NATIONAL LAB HAS BEEN HELPING. HELPING IN STANDARDS FOR SEROLOGIC TESTING AND THIS IS A PROBLEM WITH DIFFERENT TESTS ACROSS THE COUNTRY AND WORLD AND SAME FOR VACCINE TRIALS TO TRY TO RAISE THE ANTIBODY RESPONSE AND IT'S NOT STRAIGHTFORWARD SO WE'VE BEEN WORKING ON ZERO PREVALENCE DATABASE AND HAVE OTHER WE CAN DISCUSS IF THERE'S TIME AND INTEREST. NEXT SLIDE, PLEASE. SO THERE'S 21 GRANTS AND FOUR CONTRACTS TO CREATE THESE CAPACITY-BUILDING CENTERS. YOU MAY REMEMBER THE FREDERICK NATIONAL LAB IS PLAYING A LARGE ROLE IT'S THE COORDINATING CENTER AND FOSTER COLLABORATION ACROSS THE COMPONENT TO FUNCTION AS AN INTERACTIVE AND COLLABORATIVE NETWORK. WITH EACH PURSUING ITS OWN WORK AND COLLABORATING AND LOOKING AT CELLULAR AND IMMUNE RESPONSE TO SARS COV2 TO DEVELOP BETTER DIAGNOSTICS AND VACCINES AND I BELIEVE SOME FOUNDATION IMMUNOLOGIC SCIENCE WILL BE IMPORTANT FOR CANCER. THE RESEARCH CONDUCTED WILL BEGIN TO IMPACT FUNDAMENTAL QUESTIONS THAT HAVE PRESSING PUBLIC HEALTH IMPORTANCE AND DOES DISEASE SEVERITY CORRELATE WITH LONG-TERM IMMUNITY AND DO PEOPLE WITH HEALTH CONDITIONS SUCH AS CANCER HAVE WORSE OUTCOMES AND WHAT IS THE PREVALENCE OF SARS COV2 INFECTION ZERO PREVALENCE IN THE U.S. ACROSS GROUPS AND RACIAL ETHNIC GROUPS AND URBAN AND RURAL POPULATIONS. LESSONS LEARNED WILL BE IMPORTANT TO THE PUBLIC HEALTH RESPONSE TO PROVIDE GUIDANCE HOW TO BEHAVE DURING THE PANDEMIC. ONE OF THE THINGS WE'VE BEEN DOING IS WORKING ON A DEEP WAREHOUSE OF DATA RELATED TO SEROLOGIC TESTING. THESE ARE ZERO PREVALENCE STUDIES. MANY HAVE BEEN REPORTED. AND STATES HAVE DONE THEM AND COUNTRIES HAVE DONE THEM AND THERE ARE OFTEN HARD TO COMPARE BETWEEN STUDIES FOR METH OWE LOGIC REASONS AND OFTEN USED AS A PROXY FOR PRIOR INFECTION IN REGIONS. VERY HIGH PREVALENCE IN QUEENS VERSUS LOW PREVALENCE IN SOME PLACE IN MONTANA. THERE'S A PROXY FOR THE AMOUNT OF INFECTION AND BURDEN POPULATIONS EXPERIENCE. AT PRESENT THEY'RE IMPERFECT AND ONE PIECE IS A COMPILATION OF THE RESULTS WITH NOTATION OF DIFFERENT METHODOLOGIES USED AND CAVEATS TO THEIR INTERPRETATION. NORMALLY THIS WOULD BE AN EFFORT THE CDC WOULD TAKE ON FOR A VARIETY OF REASONS. THE CDC ASKED THE NCI TO HELP. WORKING WITH CDC AND NIAID WE HAVE A WAREHOUSE AND DASHBOARD. IT TURNED OUT TO BE A GOOD PLACE BECAUSE IT'S NOT THAT DIFFERENT FROM WHAT WE'VE BEEN DOING FOR THE CLINICAL TRIALS REPORTING PROGRAM. IT'S EXPERIENCED GATHERING THE DATA SO IT'S USING IN THE SEROLOGY DATABASE. IT STARTED IN JULY IN THE BIO MEDICAL APPLICATION DEVELOPMENT CENTER IN FREDERICK. THE TEAM WAS ENGAGED WITH THEIR EXPERIENCE. ENGINEERS DUPLICATED SOME OF THE FUNCTIONALITY INCLUDING DATA WAREHOUSE AND CLOUD INFRASTRUCTURE TO QUICKLY CREATE A WORKING PROTOTYPE AND SOME OF THE CURATION STAFF BEGAN EXTRACTING THE PUBLICATIONS IN VARIOUS DATA SOURCES TO POPULATE THE WAREHOUSE. IN LATE AUGUST IT MIGRATED TO ESSEX MANAGEMENT A CONTRACT ADMINISTERED BY CBIT AND HAS BEEN A MAJOR CONTRACTOR FOR THE PRECISION MEDICINE INFRASTRUCTURE AND THE ORIGINAL STAFF WHO CONTINUES TO WORK ON IT AND NOW WE SHOULD HAVE A WORKING VERSION OF THIS READY FOR THE CHURCH COMMUNITY VERY SOON THAT WILL ALLOW THEM TO DOWNLOAD THE AVAILABLE DATA AS IT IS USED FOR OTHER PURPOSES. THE DATA HAS TO BE POPULATE AND WE'RE PRESENTLY WAITING ON DATA FROM CDC AND WE HAVE SERVICE ONGOING THEY DO THROUGH A VARIETY OF CAPABILITIES. AS THE DATA BECOMES AVAILABLE THE DATA IN THIS DASHBOARD WILL BECOME MORE USEFUL. HERE'S HOW THE MOCK UP LOOKS. BY ZIP CODE OR COUNTY OR STATE LEVEL TO LOOK AT WHAT TRIALS HAVE BEEN DONE IN THE AREA AND SEE TIME TRENDS AND I THINK IT DOESN'T TAKE IMAGINATION TO KNOW HOW IT'S USEFUL FOR A PUBLIC HEALTH AUTHORITY THAT WANTED TO TAILOR MONITORING PROGRAM OR OUTREACH PROGRAM AND IT COULD BE USEFUL. IT WILL ALSO IDENTIFY THE HOLES IN ZERO PREVALENCE TESTING NATIONALLY. WE HAVEN'T TALKED MUCH LATELY ABOUT THIS LAB IT'S STILL WIDELY USED BY THOSE IN NANO TECHNOLOGY FOR UNIFORM CHARACTERIZATION OF NANO PARTICLES AND THE WORK CONTINUES DURING THE PANDEMIC. IT'S IMPORTANT FOR FORMULATIONS FOR NOVEL THERAPEUTIC INTENT AND HERE'S A PUBLICATION SHOWING THE CAPABILITIES IT HAS AND IT INVOLVES THE TARGETED PRODRUG AND AT THE CUTTING EDGE OF NANO TECHNOLOGY THERAPEUTIC DESIGN. I'D LIKE TO TALK ABOUT THE MATCH FAMILY OF TRIALS. THIS IS AN AREA INTERESTING WORK AT THE NCI WHERE FREDERICK NATIONAL LAB PLAYS KEY ROLES. I THINK PROBABLY ALL ARE FAMILIAR WITH MATCH. MATCH ENROLLED THOUSANDS OF PATIENTS AT 1100 SITES AND THE FASTEST TRIAL FOR NCI AND IT CREATED IT WAS REALLY TESTING AT LARGE SCALE THE IDEA OF A BASKET TRIAL AND CHARACTERIZE PATIENTS AND ALLOCATE THEM TO THERAPY BASED ON THE MOLECULAR FEATURES OF THE TUMOR AND MATCH WAS A TREMENDOUS SUCCESS AND ADVANCED THE PARADIGM OF THE BASKET TRIAL WHICH IS NOW SIMULATED IN ONCOLOGY EVERYWHERE AND IN OTHER DISEASE AREAS AND USED FOR ALS AND ONE OF THE FOLLOW ON AND ANOTHER MATCH HAS MANY ARMS OPEN AND I THINK WE'VE SPOKEN ABOUT THAT AS WELL BUT NOW WE PLAN WHAT COMES NEXT AND WHAT HAPPENS IF YOU BELIEVE IN THE PARADIGM AFTER MATCH AND PEDIATRICS MATCH. WE'RE BEGINNING TO PLAN THOSE EFFORTS IN THE NCI. WE HAVE A FEW TRIALS IN MIND. COMBO MATCH, IMMUNOMATCH AND IMMUNE ONOLOGY. THE TRIALS WOULD BE LIKE MATCH IN SOME WAYS BECAUSE THEY'RE BASKET TRIALS THAT WILL COMBINE PATIENT SPECIFIC CHARACTERISTICS TO ALLOCATE PATIENTS TO THERAPY AND TUMOR CHARACTERIZATION WILL BE THE EXTENSIVE GENOMIC ANALYSIS AS IN MATCH AND OTHER FEATURES INCLUDING FLOW CYTOMETRY FOR EXAMPLE AND WILL DIFFER IN THEIR GOALS OF THE TRIAL. WE LEARNED A LOT FROM MATCH HOW TO MAKE IT WORK FROM AN OPERATIONAL POINT OF VIEW AND THEY'LL BE APPLIED IN THE FUTURE OF MATCH TRIALS AND THE GOAL OF COMBO MATCH IS TO TRY AND TAKE COMBINATION THERAPIES THAT ARE BASED ON MOSTLY CELL CULTURE RESULTS AND TRY TO TEST THOSE IN A WAY THAT'S RAPID TRANSLATION IN HUMAN USE AND ALLOW FOR THE DEVELOPMENT OF NOVEL COMBINATIONS WHICH HAS BEEN A REAL PROBLEM FINDING RATIONALE COMBINATION FOR DISCOVERY AND MYELO MATCH WILL FOCUS ON NDS AND IN VARIOUS STATES [NO AUDIO] THERE'S MAJOR INVESTMENT TO ALLOW ALL NCT GROUPS TO USE THEIR INSTANCES TO REPORT ALL THE INFO TO A SINGLE DATABASE. IN RETROSPECT IT SEEMS OBVIOUS ID SHOULD HAVE HAPPENED ALL LONG BUT IT'S NOT HAPPENED BEFORE AND IT WILL FACILITATE THE CHANGE OF GENOMIC AND CLINICAL INFORMATION. FOR COMBO MATCH IT WILL BE OPEN ACROSS THE SITES SIMILAR TO THE WAY NCI MATCH WAS RUN. EACH GROUP WILL MANAGE A SUITE OF TRIALS WITH PRE-CLINICAL RATIONALE. THE GOAL IS FOUR TO SIX SINGLE ARM OR RANDOMIZED PHASE II TRIALS FOR EACH PAIR OF THERAPIES. AS A STARTING POINT WITH ACCRUAL GOAL OF STUDIES AND TRIALS BASED ON THE COMBINATION. THE INITIAL SCREENING WILL BE DONE BY OUR NETWORK OF 30 NOW PLUS SITES. ONCE A PATIENT PASSES INITIAL SCREENING WE'LL CONTAIN A FRESH BIOPSY FOR INITIAL CHARACTERIZATION. WE THINK THE HIT RATE THE ALLOCATION OF THERAPY RATE FOR SCREENING PATIENTS WILL BE HIGHER IN COMBO MATCH FOR REASONS I CAN EXPLAIN AND HOPE TO HAVE ADDITIONAL ACCRUAL IN 2021 AND IMPORTANTLY A VERY HIGH BAR OF IN VIVO EVIDENCE REQUIRED TO MOVE A PAIRING IN TO A CLINIC AND USE OTHER EXPERIMENTAL TRIALS AND PHASE I NETWORK FOR TESTING OF THE NOVEL COMBINATIONS FREDERICK NATIONAL LAB PLAYS A BIG ROLE IN MANY WAYS WITH CLINICAL SUPPORT AND DATA HANDLING AND HELPS WITH THE PRE-CLINICAL VALIDATION OF THE THERAPIES. SOME IS USED FOR THE PATIENT-DERIVED MODELS AND IT'S FAMILIAR TO FNLAC WE HAVE BEEN CREATING A REPOSITORY OF PDX MODELS AND COMBOS THAT CAN BE VALIDATED IN SOME PDXs WILL BE PRIORITIZED. THE ONGOING WORK AND HELP SERVE FOR THE PRE CLINICAL VALIDATION FOR COMBO MATCH CREATE A HIGH BAR FOR ENTRY. THERE'S A COMBINATION OF PAIRINGS SOMEONE CAN DO AND WE WANT TO MAKE SURE WE DON'T HAVE SPECIFIC BIASSED TO WELL STUDIED AGENT AND HOPE BY VALIDATION IN PRE CLINICAL MODELS WE CAN FIND PAIRINGS THAT WEREN'T EXPECTED AND NOT JUST DOING THE SAME OLD DRUGS BASED ON SOMEONE'S NOT NOVEL IDEA. SOS AS THE FIRST TIME THERE'LL BE A CONSISTENT APPROACH IN MYELO MATCH. IT REQUIRES A NEW LAB TO PROVIDE NOT ONLY GENOMICS AND OTHER MOLECULAR FLOWS, ETCETERA AND ON A RAPID TIME LINE. THIS IS THROUGH FREDERICK NATIONAL LAB. MYELO MATCH SHOULD OPEN IN LATE TO MID 2021 AS WELL. IT'S A COMPLEX DESIGN THAT ALLOWS PATIENTS TO ENTER AT VARIOUS STAGES DEPENDING ON WHAT KIND OF DISEASE AND WHETHER THEY NEED TRANSPLANT. IT'S TRANSITION FROM ONE CLINICAL TO THE TEXT AND AS HUMAN BURDEN IS REDUCED OVER THE COURSE OF TREATMENT THERAPIES CAN TARGET MRD. THE ASSAYS WILL REQUIRE CLINICAL VALIDATION AND MYELOMATCH WILL CONDUCT ASSAYS AS NEEDED. THE GROUP WILL COMPLETE THE INITIAL GENETIC SCREENING BUT ALL OTHER TESTS RUN THROUGH THE NCI V NET EFFICIENCY AND OPEN TO ALL NCI SITES AS MENTIONED. A LITTLE NOR GRANULARITY AS IT WORKS AS PATIENTS ARE ENROLLED ON THE SCREENING PROTOCOL. SPECIMENS ARE SENT TO ND NET AND SENT TO THE INFORMATICS ENGINE. IT'S RETURN WITHIN 72 HOURS FOR PROTOCOL ASSIGNMENT AND THEN A SECOND. AND THE INFORMATICS WILL ALLOW POSTKWER YOS -- POST QUERIES FOR HYPOTHESIS GENERATION AND PROVIDE END POINT DATA INCLUDING RESPONSE AND TARGETING ASSOCIATED MUTATIONS AND OTHER BENEFITS THAT CAN BE USED TO PRIORITIZE DEFINITIVE TRIALS WHEN BIG EFFECTS ARE NOTED IN THE CLINICAL TRIAL. THEY'RE TWO EXAMPLES OF WHAT COMES NEXT FOR MATCH AND HOW NCI CAN LEAD THE PARADIGM OF TRIAL FOR WHAT COMES NEXT, COMBINATIONS AND MYELO MALIGNANCIES AND SO FORTH. OTHER EXAMPLE OF THINGS WE'RE DOING AT FREDERICK THAT CAN OCCUR DURING THE PANDEMIC WITHOUT MUCH DISRUPTION WE HAVE AN ANNUAL TECHNICAL SHOWCASE IMPORTANT FOR PRESCRIBING TECHNOLOGY DEVELOPED WITH NCI AND THE OFFICE OF TECHNOLOGY TRANSFER AT NCI. THIS YEAR IT HAPPENED AND BROUGHT TOGETHER 300 VIEWERS FOR COLLABORATION AND NEW TECHNOLOGIES. IT HIGHLIGHTED CAPABILITIES FOR FREDERICK NATIONAL LAB AND NCI AND THE GREATER FREDERICK REGION. THIS YEAR GIVEN THE NOVEL VIRTUAL FORMAT IT REACHED A DIFFERENT AUDIENCE AND IN FACT THIS YEAR WE HAD ATTENDEES FROM ALL OVER THE WORLD, SWITZERLAND, BRAZIL AND INDONESIA AND CHINA. IT'S AN INTERNATIONAL EVENT AND THESE KINDS OF VIRTUAL EVENTS CAN BE VERY USEFUL FOR SOME PURPOSES. I WANTED TO TAKE A MOMENT ABOUT OTHER ONGOING SCIENCE AT THE NCI THAT MAY BE OF INTEREST. THIS IS AN IMPORTANT PUBLICATION THAT CAME OUT IN AUGUST FROM THE NCI FROM DR. NADIA HALLINDER AND OTHER INVESTIGATORS AND WAS WORK IN COLLABORATION WITH INVESTIGATORS AT HARVARD AND U.C. MICHIGAN AND STRIKINGLY IMPORTANT IN WHAT IT TELLS US ABOUT THE BROADER LANDSCAPE OF CANCER ON A POPULATION LEVEL. LUNG CANCER MORTALITY HAS BEEN DECLINING FOR DECADE IN THE UNITED STATES LARGELY BECAUSE OF TOBACCO CONTROL. BUT IN RECENT YEARS USING SOURCES OF DATA LIKE THE ANNUAL REPORT FOR THE STATS OF CANCER NCI BECAME MORTALITY IN LUNG CANCER IS FALLING FASTER THAN INCIDENT. THIS IS A PUZZLING PATTERN OF STATISTICS. AT THE SAME TIME WE'RE SEEING A SIMILAR PATTERN FOR MEL KNOW NA. WE ASKED DEL KNOW MA AND WE ASKED -- MELANOMA AND WE ASKED THEM TO LOOK INTO FOR WHAT ACCOUNTED FOR THE IMPRESSIVE DECREASES IN MORTALITY RELATIVE TO INSTANCES. THEY USED A NOVEL ANALYTIC TECHNIQUES ON SEAR DATA AND STUDIED SMALL CELL LUNG CANCER AND NON-SMALL CELL LUNG CANCER AND CAME TO THE CONCLUSION A SIGNIFICANT PROPORTION TO SMALL CELL LUNG CANCER IS BECAUSE OF NOVEL THERAPEUTICS AND FOR NON-CELL LUNG CANCER THERE WAS QUITE A NICE EFFECTIVE THERAPY. IMPORTANTLY IN 2016 IS BEFORE IMMUNOTHERAPY HAS PENETRATED NON-SMALL CELL LUNG CANCER THERAPY AND BEFORE SCREENING WAS UNDERWAY IN THE UNITED STATES. WE THINK THE EFFECT OF THERAPEUTICS IN THIS TRIAL RELATES TO KINASE INHIBITORS AND MUCH MORE ELIMITED EFFECT OF OTHER THINGS. WE THINK AS SCREENING INCREASES WE'LL SEE FURTHER REDUCTION IN THE MORTALITY. I READ ABOUT THIS IN AN EDITORIAL HOW PROGRESS IN LUNG CANCER ILLUSTRATES WHAT'S POSSIBLE IN CANCER RESEARCH. WHEN I STARTED AS A FELLOW IN MEDICAL ONCOLOGY, MELANOMA AND LUNG CANCER WERE THE TWO WORSE MALIGNANCIES WITH TERRIBLE PROG PROGNOSISES AND NOW WORE SEEING THE PATTERN WHERE MORTALITY IS CLIMBING QUICKLY BECAUSE OF THE SUCCESS OF NOVEL THERAPEUTICS. AND A VARIETY OF NON-THERAPEUTICS. THAT IS INSPIRING FOR THE CANCER FIELD WE STILL HAVE PROGRESS TO MAKE IN OTHERS BUT IT PROVIDES HOPE WHAT TECHNOLOGY CAN LEAD TO WHEN WE UNDERSTAND THE BIOLOGY OF THE CANCER. HERE'S AN EXAMPLE HOW WE WANT TO CONTINUE TO SUPPORT GREAT CUTTING-EDGE, INNOVATIVE SCIENCE AND IT WAS A PARTNERSHIP BETWEEN THE NATIONAL CANCER INSTITUTE AND CANCER U.K. TO SUPPORT CANCER GREAT CHALLENGES. IT'S SIMILAR TO THE PROVOCATIVE QUESTIONS PROGRAM BUT ADDS INTERNATIONAL, MULTI DISCIPLINARY TEAM THAT INCLUDE PATIENT INVOLVEMENT. THIS DOES NOT REPRESENT RESOURCES FROM OTHER NCI PROGRAMS BUT RATHER REPURPOSING OF THE P.Q. FUNDS. IN OFF YEARS WE'LL NOW SUPPORT THE PROGRAMS AND IN OTHER YEARS WILL SUPPORT THE P.Q. PROGRAM. BOTH PROGRAMS CREATE SCIENTIFIC TEAMS TO TAKE ON NOVEL CHALLENGES THE NCI IDENTIFIES. IT INCLUDES SIGNIFICANT INVESTMENT IN U.K. AS WELL AND TO DATE AMERICAN SCIENTISTS COMPETED IN THE U.S. GRAND CHALLENGES PROGRAM A PREDECESSOR TO THIS PROGRAM AND DON'T BELIEVE IT THE CHANGE IN THE FUTURE. MANY OF THE TEAMS SUPPORT THIS PARTNERSHIP WILL BE AMERICAN TEAMS OR TEAMS THAT INCLUDE AMERICANS AND WE THINK THIS WILL BE A GREAT PROGRAM FOR AMERICAN SCIENCE. THE CHALLENGE HAS BEEN IDENTIFIED BY A GROUP USING A PROCESS THAT INCLUDES INPUT FROM THE COMMUNITY. THE 2021 CHALLENGES HAVE BEEN PUBLISHED TODAY AND 13 TEAMS LOOK AT THEM AND ASSEMBLE TO SEE IF THEY HAVE THE CAPABILITIES TO TAKE ON THE QUESTION AND THERE'S EXPRESSION OF INTEREST WHICH IS ACCEPTED THROUGH APRIL 2021. I BELIEVE IT'S A GREAT PROGRAM TO SUPPORT HIGH-RISK AND INNOVATIVE RESEARCH TO OUR HEAVILY INVESTIGATED PORTFOLIO IN THE RPG FIELD AND THINK IT WILL STIMULATE INNOVATIVE AREAS TO FURTHER KNOWLEDGE IN CANCER. TO CLOSE I'D LIKE TO TALK ABOUT THE IMPORTANT ANNIVERSARY WE'RE REACHING. 2021 IS THE 50th ANNIVERSARY OF THE NATIONAL CANCER ACT AND DID NOT CREATE NCI BUT DID ACCELERATE A NUMBER OF PROGRAMS THAT WERE THE BACKBONE OF THE NATION'S INVESTMENT IN CANCER REASON AND LIST OF THINGS ARE SHOWN HERE. THERE WAS SEER THEY TOLD THE NCI TO CREATE A NATIONAL DATABASE OF CANCER AND THAT TURNED OUT TO BE SEER. I ARGUE THE MOST IMPORTANT DATABASE IN THE WORLD AND MORE SO THROUGH LINKAGE THROUGH MEDICARE AND OTHER DATA SETS. NATIONAL CANCER ACT CREATED THE NATIONAL CANCER CENTERS PROGRAM WHICH IS ONE OF THE REAL UNDER APPRECIATED SECRETS OF THE NCI AND CAPABILITIES AND THE PROGRAM HAS BEEN HIGHLY IMPORTANT FOR THE CANCER RESEARCH AND LED TO A GENERATION OF NEW SCIENTISTS COMING TO CANCER AND SUPPORTED TO OUR CANCER CENTER AND UNDER LIES INTEREST IN CANCER RECEIVED OVER THE YEARS AT THE NCI. THE NATIONAL CANCER ACT PROVIDED SPECIAL ACCESS AT THE NCI TO CONGRESS AND THE WHITE HOUSE BY MAKING THE NCI PRESIDENTIAL DIRECTOR APPOINTEES AND ALSO GIVING NCI THE ABILITY TO PASS THE BYPASS BUDGET WHERE WE CAN PASS CONGRESS AND TELL CONGRESS ABOUT OUR NEEDS FOR FUTURE FUNDING. AND ANOTHER THING THE NATIONAL CANCER ACT DID WAS CREATED A NATIONAL LAB BY PROVIDING NCI WITH A SPACE TO CREATE THE LAB FOR TARGETED HIGH-PRIORITY CANCER PROJECT WITH NOVEL CAPABILITIES OF CONTRACTING RELATED TO A NATIONAL LAB WHICH I THINK ARE FAMILIAR TO THE GRUP AND IMPORTANT FOR THE NCI MISSION. THIS IS A BIG ANNIVERSARY. IT'S BEEN IMPORTANT. AND IN ADDITION TO DOING ALL THESE THINGS AND SUPPLYING NEW FUNDING FOR THE NCI IT IS A GREAT DEAL FOR PATIENTS PRIOR TO THAT CANCER WAS UNSPOKEN DIRTY WORDS AND THE NATIONAL CANCER ACT BROUGHT CANCER OUT TO THE GREAT LIGHT AND MADE IT SOMETHING PEOPLE COULD TALK ABOUT AND HAD A HUGE IMPACT IN THE ADVOCACY MOVEMENT RELATED TO CANCER AND MAKING THE DISEASE WE'VE BEEN ABLE TO MAKE PROGRESS ON. THE NCI WILL BE CREATING AN EDUCATIONAL PROGRAM AROUND MATERIALS WE HOPE YOUR INSTITUTIONS MAY CONSIDER USING TO HELP PASS LONG THE MESSAGE. THE NCI IS MUCH BIGGER THAN JUST THE NCI AND WE HOPE THE ENTIRE CANCER RESEARCH AND CAREGIVER COMMUNITY WILL EMBRACE THIS AND TALK ABOUT THE THINGS WE'VE ACCOMPLISHED IN THE LAST FEW YEARS IN A WAY THAT IS COMMON AND EFFECTIVE AT BOTH THE GENERAL PUBLIC WILL UNDERSTAND AND APPRECIATE AND CONGRESS AND IMPORTANT STAKEHOLDER REPRESS. THAT'S MY PRESENTATION TODAY. I'D BE HAPPY TO TAKE QUESTIONS ON THESE TOPICS OR OTHERS I DIDN'T GET TO. THANK YOU ALL FOR JOINING. >> THANKS, NED. WE GOT SOME TIME FOR QUESTIONS. JUST SPEAK UP. IT'S HARD TO SEE HANDS. >> THIS IS LINCOLN STEIN. DR. SHARPLESS, I ENJOYED YOUR PRESENTATION. I HAVE A QUESTION ABOUT THE NCI COMBO MATCH CLINICAL TRIAL. HOW MUCH TIME DOES IT TAKE TO CREATE THE EX VIVO MODELS AND HOW'S IT CHANGE THE DESIGN OF THE CLINICAL TRIAL. >> I THINK JIM DOROSHOW IS ON SO I'LL LET HIM SPEAK TO THAT BUT I'LL SAY THE UNIVERSE OF POSSIBLE COMBINATIONS IS MUCH LARGER THAN THE BANDWIDTH FOR SOMETHING LIKE COMBO MATCH. I MENTIONED FOUR TO SIX COMBINATIONS TO START OUT WITH. SO HOW DO YOU PICK THOSE COMBINATIONS FOR TESTING IS AI COMPLICATED QUESTION. SUFFICE TO SAY THE NCI IS PLANNING ON USING A HIGH BAR. WE WANT TO HAVE COMBINATIONS GOOD FOR DATA SETS AND NOT A SINGLE ONE-OFF PAPER. AND ADDITIONALLY, WE'D LIKE TO PICK COMBINATIONS WHERE WE THINK WE HAVE AN IDEA WHY THEY WORK. LIKE THIS COMBINATION OUGHT TO BE EFFECTIVE IN MUTANTS OR IN RATS SO SOME SORT OF UNDERSTANDING OF WHEN THE COMBINATION SHOULD BE MAXIMALLY USEFUL. AS YOU KNOW, ONCE YOU START EVEN IDENTIFYING THE COMBINATIONS BASED AN PRE CLINICAL MODELS AND COMPARE THEM IN VIVO IN HUMANS IS A DOSING ISSUE AND HAVE TO INVOLVE THE ECTCN AND THIS IS HARD AND IT IS A HARD TOPIC. JIM, DO YOU WANT TO SAY ANYTHING ABOUT HOW WE'LL PRE CLINICALLY VALIDATE? >> JUST TO CLARIFY THE QUESTION THOUGH I APPRECIATE THE ANSWER BUT WHAT I WAS CURIOUS ABOUT IS MY UNDERSTANDING IS FOR EVERY PATIENT YOU HAVE TO CREATE A PDX OR CELL LINE -- >> NO. I DIDN'T EXPLAIN THAT WELL. >> WE'LL ONLY HAVE SIX REGIMENTS THAT WILL BE 20 MONTHS OF DATA. >> IT'S NOT INDIVIDUALIZED. ONE IS CONCEPTION. >> ONE WOULD LOVE TO BE ABLE TO DO THAT BUT THAT WOULD TAKE FOREVER. AND WE LOOKED AT THE INVESTIGATORS AND THE GROUPS PRESENTING EVERY WEEK TO FIND THE BEST DATA THAT'S AVAILABLE. THERE HASN'T BEEN ANY DELAY IN THE CONTEXT YOU FRAMED YOUR QUESTION. >> I WILL ADD INVESTIGATORS HAVE COME TO THE NCI TO TALK ABOUT DOING SOMETHING LIKE WHAT YOU DESCRIBED USING PERSONALIZED APPROACH FOR ORGANOID. THAT APPROACH HAS BEEN SOMETHING TALKED ABOUT. WE STILL HAVEN'T FIGURED OUT HOW TO DO THAT THOUGH THERE'S ONGOING INTEREST IN THAT AND THAT IS POSSIBLE. I DON'T THINK PDX'S ARE POSSIBLE BUT ORGAN OIFDS MAY BE POSSIBLE -- ORGANOIDS MAY BE POSSIBLE IF YOU THINK THEY'RE REPRESENTATIVE? >> ANY QUESTIONS? >> THIS IS TIM CHAN. YOU MENTIONED IMMUNOMATCH AND THERE'S NEW THERAPIES PLUS OR MINUS CHEMO PLUS VARIOUS NDPD1s PRODUCING AMAZING RESULTS, FRANKLY. THE QUESTION IS HOW BEST IN YOUR OPINION TO STRUCTURE WHAT TYPES OF TRIALS GO TO WHAT BINS? BECAUSE MANY ARE COMBINATION TARGETED THERAPIES AND IMMUNOTHERAPIES. >> I'LL LET JIM ANSWER SPECIFICS ABOUT IMMUNOMATCH AND THE OVER ARCHING STATEMENT IS WE FOLLOWED THE FIELD WITH GREAT INTEREST. AT FDA THE FIRST DAY ON THE JOB PEOPLE STARTED YELLING AT ME ABOUT 1100 CLINICAL TRIALS NONE OF WHICH WE'LL FILL AND ALL OF WHICH HAVE SOMEBODY'S RATIONALE. I'VE BEEN IMPRESSED WHO WOULD THINK PLATINUM-BASED THERAPIES WOULD PAIR WELL WITH OTHERS AND IN SOME TRIALS THAT'S THE WINNER. NO THERAPIES THERE'S IN IN -- INFINITELY AMOUNT OF TRIALS AND YOU CAN'T USE PDXs OR ORGANOID. IT'S TOUGH. JIM, THOUGHTS ON IMMUNOMATCH? >> BASICALLY THE MOLECULES THAT YOU WOULD CONSIDER TARGETED WILL FALL IN THE REALM OF COMBO MATCH AND COMBINATIONS OF IMMUNOLOGIC AGENT WILL FALL IN THE IMMUNOMATCH AREA BUT THE WHOLE PURPOSE OF SETTING UP THE TRIAL IS TO HAVE A NATIONAL STANDARDIZED WAY TO MEASURE THE THINGS THAT ALL OF US WANT TO MEASURE SO THAT CAN BE DONE IN A CENTRALIZED WAY AND HAVE A NATIONAL PUBLICLY AVAILABLE DATABASE WITH THE THINGS WE ALL WANT AND DON'T GET DONE IN EXACTLY THE SAME WAY FROM INSTITUTION TO INSTITUTION. THAT'S THE FIRST TENET IS WE'LL ESTABLISH A STANDARDIZED WAY TO WHATEVER WE'RE GOING MEASURE THAT'S APPROPRIATE FOR THE STUDIES WILL BE DONE IN A CONSISTENT SOP BASED VALID FASHION. >> WE HAVE THIS ONGOING INITIATIVE AND THAT HAS BASICALLY A LOOK AT BIOMARKERS IN EXISTING CLINICAL TRIAL SAMPLES AND ROBUST AND HIGHLY VALIDATED ASSAYS AND WE MAY LEARN THINGS FROM THAT WORK THAT WILL HELP INFORM EACH TRIAL DESIGN AS WELL. >> MY UNPLEASANT RESPONSIBILITY IS TO KEEP US ON TIME. WE'RE GOING TO MOVE ON AND EXCHANGE QUESTIONS AND ANSWERS IN THE CHAT BOX. BEFORE WE DO I WANT TO WELCOME DENISE MONTEL WHO JOINED AFTER HE PRESENTATION. GOOD TO SEE YOU. THE NEXT PRESENTATION IS FROM JIM DOROSHOW. DISCUSSION OF RESOURCE TO SUPPORT EXTRAMURAL RESEARCH. >> THANKS SO MUCH. THIS SAY CHANCE FOR ME TO REVIEW SOME OF YOU THE PROGRESS THAT'S BEEN MADE AND SOME AREAS THAT ARE MOST ACTIVE AT FREDERICK IN SUPPORT OF THE EXTRAMURAL COMMUNITY IN PROVIDING SCIENTIFIC RESOURCES. ONE IS BDP WHERE WE PRODUCE BIOLOGICALS AND SOME ON THE PDMR AND IT'S APPROPRIATE GIVEN THE HIATUS YOU KNOW HOW WE RESPOND TO THAT AND WHERE WE STAND AT PRESENT. IT INTRODUCES THE PROGRAM STARTED MANY YEARS AGO WITH THE SPECIFIC GOAL OF PROVIDING TECHNICAL EXPERTISE AND SERVICES TO DO PHYSICAL TESTING AND DEVELOP MANUFACTURING PROCESS TO MANUFACTURE BIOLOGICALS FOR EARLY STAGE CLINICAL TRIALS AND THAT WAS THE GOAL THEN AND REMAINS THE GOAL. IT'S NOT WELL KNOWN THAT THE FACILITY IS USED BY THE FDA TO TRAIN INSPECTORS AND TO PRODUCE TECHNOLOGY TRANSFER DOCUMENTATION THAT HELPS THE REGULATORY PACKAGES USED IN THE COMMUNITY. WHAT ARE THE COMMON HURDLES. WHAT DO INVESTIGATORS COME TO THE PDP AND COME TO NCI FOR. THEY NEED HELP USUALLY FOR BIOLOGICALS FOR LIMITED MARKETS AND THEY INVOLVE HIGH-RISK TECHNOLOGY. WE'RE WILLING TO TAKE ON A VARIETY OF PRODUCTS AND ATTEMPTED PROJECTS THAT INDUSTRY WOULD SHY AWAY FROM. WE ALSO HAVE A STRONG BACKGROUND IN WORKING IN FIRST IN CLASS PRODUCTS. IT MAY TAKE LONGER THAN ONE WOULD SEE IN INDUSTRY BUT ULTIMATELY CAN BRING TO HELP PATIENTS PROJECTS THAT WOULD NOT OTHERWISE BE SUPPORTED. IT'S IMPORTANT TO POINT OUT LIKE OTHER THINGS WE DO AT FREDERICK, THE FOLKS IN THE EXTRAMURAL COMMUNITY THAT OTHER NEIGH ORIGINATE THESE RETAIN PROPERTY RIGHTS AND THE GOVERNMENT HELPS ROW DOUSE A REGULATORY -- PRODUCE A REGULATORY PACKAGE BUT ALL THE RIGHTS REMAIN WITH THE ORIGINATORS AND INSTITUTIONS FOR WHICH THEY COME. HALF COME AS INDEPENDENT APPLICATIONS AND GET REVIEWED BAY PEER-REVIEWED PROCESS WITH THE APPROPRIATE EXPERTISE AND WE HAVE A NUMBER OF PROJECT COME FROM NIAID AND NCATS AND MANY PROJECTS WHERE WE'VE HELP DOD. THIS ACTIVITY AND IT OCCUPIES TWO FULL FLOORS OF OUR NEW FACILITY IN FREDERICK. THERE'S EVERYTHING FROM 1,000 LITER BIOREACTORS THAT CAN MAKE PROTEINS IN HUGE AMOUNTS FOR VARIOUS PROJECTS TO BACK END FACILITIES FOR BOTTLING UNDER THE PROCESS THERE. WE CAN START WITH A PROCESS AND IT COMES FROM A LABORATORY INVESTIGATOR AND END UP WITH VIALS OF QUALITY MATERIAL WHETHER IT'S AN ANTIBODY OR ANYTHING ELSE. I'LL TALK ABOUT THE EXPANDED NEW CELL THERAPY ACTIVITIES. YOU HEARD ABOUT THAT FROM THE LAST MEETING AND THEY'RE PROGRESSING WELL AND THE NEW BLOOM IS BEING FINALIZED FOR USE AND SHOULD BE READY IN THE NEXT FEW WEEKS AS WELL AS THE EXPANSION TO BE ABLE TO DO SEVERAL SUITES FOR OTHER PROJECTS. THAT SHOULD BE READY TO OCCUPY THAT SPACE WITHIN A YEAR. TO GIVE AN IDEA OF THE PAST HISTORY AND WHERE WE STAND IN TERMS OF THE KIND OF PRODUCTS. ALMOST ANYTHING YOU CAN THINK OF FROM THE ANTIBODIES, IMMUNOTOXINS AND VIRUSES, A VARIETY OF DIFFERENT VACCINES AND PROJECTS FOR NIAID IT INCLUDES TWO PRODUCTS LICENSED AND COMMERCIALLY AVAILABLE AS WE SPEAK. FIRST I'M GOING TO TALK ABOUT IS THE CH14 AND 18 RECEPTOR ANTIBODY. IT'S A GREAT STORY AND THE KIND OF THING THAT NCI SHOULD BE ENGAGED IN. THIS PROJECT I WAS ON THE EXPERIMENTAL STUDY SECTION AND IT GOT APPROVED TO STUDY GD2 RECEPTORS IN NEUROBLASTOMA AND THAT WORK WENT VERY WELL. IT PRODUCED AN INITIAL MONOCLONAL ANTIBODY TO TAKE TO PHASE I TRIAL. IT WAS APROJECT -- A PROJECT APPROVED BY NCI AND ANTIBODY AND PHASE I STUDY WAS DONE AND THERE WERE EXCELLENT RESULTS AND THE DECISION WAS MADE FOR THE NCI TO GO TO FULL-SCALE PRODUCTION OF THE ANTIBODY LEADING TO A SUFFICIENT AMOUNT OF ANTIBODY TO CONDUCT A PHASE III TRIAL CONDUCTED BY THE CHILDREN'S ONCOLOGY GROUP AND LED TO THIS CITED PAPER THAT LED TO A 40% IMPROVEMENT IN SURVIVAL IN THE HIGH-RISK PATIENTS AND NOW IT'S A TOTAL POPULATION OF 200 TO 250 PATIENT AS A YEAR. THE WHOLE PROCESS WAS CONTINUED. AFTER THAT INITIAL EVALUATION AND THE ANTIBODY WAS SUPPLIED AROUND THE WORLD THIS THE PRODUCT WAS OUTLICENSE AND GOT SUPPORT FROM AN INVESTIGATOR RO1 TO AN APPROVED PRODUCT. THE SECOND SLIDE IS ALSO VERY IMPORTANT AN IMMUNOTOXIN AGAINST CD42 PRODUCED IN THE INTERIM PROGRAM AND FUND TO BE -- INTRAMURAL PROGRAM AND HIGHLY EFFECTIVE IN THE TREATMENT OF A TYPE OF LEUKEMIA AND LED TO FDA APPROVAL AND COMMERCIALIZATION OF THAT PRODUCT. TO GIVE YOU AN IDEA THERE'S LOTS OF PRODUCTS THAT HAVE GONE A LONG WAYS IN THE PAST 10 YEARS. HERE'S SOME IN PRE LICENSING SPACE AND AN IMPORTANT PEP SIDE VACCINE WE HOPE CAN BE GIVEN TO DONORS TO PREVENT OCCURRENCE OF CMV. AND BEGAN AS AN IMAGING PROJECT FROM THE UNIVERSITY OF TENNESSEE AS A TREME AND THE AMYLOID PRODUCED IN FREDERICK AND USED IN PHASE I IMAGING TRIAL HAS HAD EFFICACY IN KIDNEY AND LIVER DAMAGE AND WAS LICENSED AND THE PHASE II TRIAL IS ONGOING. THIS IS AN EXAMPLE OF A FEW PROJECTS DONE IN SUPPORT OF OTHER INSTITUTES. AS YOU KNOW THE NCATS HAS A RARE DISEASE PROGRAM AND WE SUPPORT THEM IN A VARIETY OF WAYS AND IN THE PROCESS OF WORKING ON A VACCINE FOR A MALARIA VACCINE AND PROJECT FOR DIABETES WITH NIDDK AND MULTIPLE DOD PROJECTS. ONE OF THE THINGS THAT IS A MAJOR STRENGTH IS THE ABILITY TO DEVELOP, MAINTAIN AND SOPs FOR ALL THE PROJECTS AND TO DO ONGOING QC FOR THESE ACTIVITIES BASED ON THE GMP PRODUCT PRODUCED. THIS HELPS PEOPLE HAVING A CENTRAL SOURCE FOR THE SOPs AND IF WE NEED TO GO BACK FOR A TRIAL WE'RE WELL REPAIRED TO DO THAT. -- PREPARED TO DO THAT. AND I'D LIKE TO GO BACK TO SOMETHING I'VE SAID BEFORE AND IT GIVE AN UPDATE ON THE REPOSITORY AND HOW WE'VE RESPONDED TO THE PANDEMIC. THIS IS SOMETHING WE STARTED FIVE YEARS AGO TO DEVELOP A RESOURCE FOR THE ACADEMIC COMMUNITY THAT WOULD PROVIDER EARLY PASSAGE TO NOT ONLY PDXs AND ORGANOIDS AND THE CELL LINES AND CANCER ASSOCIATED FIBROBLASTS FROM PATIENTS PRIMARILY AND SUBSTANTIALLY FROM WHERE CANCERS THAT COME FROM PATIENTS BUT WITH UNDER SERVED POPULATIONS BUT TO MAKE THESE AVAILABLE FULLY ANNOTATED IN TERMS OF SEQUENCING AND EXPRESSION ANALYSES FOR THE COMMUNITY AT LOW COST. HERE'S WHERE WE ARE. AS OF A WEEK AGO WE HAVE NOW ABOUT 430 PUBLIC MODELS ACTIVELY BEING DISTRIBUTED AROUND THE UNITED STATES. I WOULD POINT OUT THOUGH WE HAVE ANOTHER 200 OR SO MODELS IN THEIR FINAL QUALITY CONTROL IN SEQUENCING AND ALL LOW PASSAGE BUT I TRULY MORE THAN HALF OF THESE MAYBE ALL OF THEM WOULD HAVE BEEN IN THE PUBLIC DOMAIN NOW IF WE HADN'T SHUT DOWN FOR THE PANDEMIC. IT'S A CONTRIBUTE TO COLLEAGUES IN FREDERICK HOW WELL THEY MAINTAINED MODELS AS TO MINIMIZE THE TIME LOST BUT STILL WE COULDN'T DO THE SEQUENCING NECESSARY TO DO THE FINAL Q.C. IN THE NEXT FEW MONTHS THE ADDITIONAL MODELS WILL COME ONLINE AND BECOME PUBLICLY AVAILABLE IT WAS A SIGNIFICANT ISSUE PEOPLE IN FREDERICK RESPONDED TO VERY WELL. AS YOU CAN SEE FROM THE DISTRIBUTION OF MODELS, YES, WE HAVE A LOT OF COLORECTAL MODELS BUT WE ALSO HAVE A SUBSTANTIAL COLLECTION AND YOU'LL SEE THE LISTING OF ADULT SOFT--YOU SARCOMAS AMONG THE LARGEST AND OTHER KINDS OF TUMORS. THIS IS ALL BECAUSE WE STARTED THE TISSUE COLLECTION WE ASKED TO FOCUS ON SOME THAT WERE LESS WELL REPRESENTED IN THE COLLECTIONS THAT WERE AVAILABLE ELSEWHERE. HERE'S A LISTING OF SOME OF THE RARE CANCER MODELS YOU SEE THE SARCOMAS WHICH ARE VALUABLE AND NOT JUST ONE BUT MULTIPLE TUMORS AND CANCERS AND OTHER THINGS NOT EASILY AVAILABLE THAT WE THINK ARE VERY IMPORTANT AND WILL GIVE US THE ABILITY TO TEST A VARIETY OF THERAPEUTICS AND SINGLE AGENT AND COMBINATIONS IN THE RARE TUMOR SPACE. WE'VE BEEN MAKING PATIENT CELL DRUG CELL LINES AND CANCER-ASSOCIATED FIBROBLASTS. THERE'S A LOT OF MODELS AND PROBABLY NOT AS FAR MODELS AS WE WOULD HAVE AND THE WORK WOULD BE IN THE PUBLIC DOMAIN IF WE WOULDN'T HAVE HAD TO DECREASE WHAT WE ARE DOING BASED ON THE PANDEMIC. THEY'RE LOW PASSAGE CELLS. I THINK IT WILL BE USEFUL AND THERE'S INTEREST IN OBTAINING THE TISSUES. AND WE HAVE PATIENT DERIVED ORGANOIDS AND ULTIMATELY WE HAD A LARGE LIBRARY OF ORGANOIDS AND THE POINT I WANTED TO MAKE IS NOT THAT THESE ARE IMPORTANT OR THEY ARE I THINK AND WE'RE DISTRIBUTING THEM BUT AGAIN TO TAKE MY HAT OFF TO MY COLLEAGUES WE HAD TO DEVELOP NEW METHODS. THERE WAS NO ESTABLISHED METHODOLOGY TO DEVELOP ORGANOIDS FROM UTERINE OR MEL KNOW -- MELANOMA CANCERS AND SAME FOR SOFT TISSUE SARCOMA AND WE'VE DONE THAT AND I THINK WILL BE USEFUL TO THE COMMUNITY. AND THERE'S AN INTEREST TO BE ABLE TO PROVIDE TO INVESTIGATORS A SUITE OF MODELS THAT INVOLVE NOT ONLY PDX FRAGMENT FOR IN VIVO BUT A 2-D AND 3-D AND FIBROBLAST MODEL ALL FROM THE SAME PATIENT SO STUDIES CAN BE DONE IN A VARIETY OF DIFFERENT WAYS OF MIX AND MATCH SCREENING, HIGH THROUGHPUT ORGANOID THROUGHPUT IN VIVO. THEY HAVE ALL BEEN SEQUENCED AND THAT'S A WHOLE OTHER STORY AND GOOD CONCORDANCE BETWEEN THE DIFFERENT TYPES OF MODELS AND SEQUENCES WE OBSERVED AND THE IDEA WAS TO MAKE THEM AVAILABLE FROM INDIVIDUAL PATIENTS THAT HAVE A KNOWN CHEMO THERAPY OR TARGETED THERAPY BACKGROUND SO INDIVIDUALS CAN PUT THEM TOGETHER AND USE THEM IN THE MOST EFFECTIVE WAY POSSIBLE FOR EXPERIMENTS. THIS TELLS YOU ABOUT THE DISTRIBUTION OF OUR MOLDS. THE LAST TIME I PRESENTED TO FNLAC WE HAD 1,000 MODELS DISTRIBUTED AND HIS SHOWS WHERE WE WERE AS OF THE FIRST WEEK IN MARCH WHEN DISTRIBUTION SHUT DOWN. WE PERHAPS REDISTRIBUTED 40 OR 50 MODELS SINCE WE REOPENED BUT THINK WE'D HAVE MORE IF NOT THOR THE SHUT DOWN AND PEOPLE ARE INTERESTED IN MANY MATERIALS, CELL LINES, FRAGMENTS, ORGANOIDS AND THE USES ARE AS MANY AS YOU COULD THINK OF. PEOPLE HAVE PROVIDED THEIR IDEAS ABOUT WHAT THEY WANT TO USE THESE THINGS FOR AND WE PROVIDED THE MODELS TO THEM AND ARE KEEPING A GOOD TRACK ON THE SUCCESS THEY HAVE WITH PROJECTS THEY HAVE OUTLINED TO HAVE INTEREST IN. HERE'S A LIST AT THE INSTITUTION AND COMPANIES WE HAVE ABOUT 3% OF THEY'LL DESIGNATED CANCER CENTERS. I REQUESTED ONE OR MORE OF THESE TYPES OF MODELS AND THERE'S MAJOR BIO TECH PHARMAFIRMS THAT ASKED FOR LARGE NUMBERS OF MODELS TO SUPPLEMENT THEIR OWN ACTIVITIES. IT'S BEEN USEFUL. I EXPECT WE'LL CONTINUE TO TRY TO MAKE EXTRAMURAL P.I.'S AWARE OF THE EXISTENCE OF THE MODELS AND WHAT HAS BEEN CLOR TO ME OVER TIME -- CLEAR TO ME OVER TIME IS ONCE PEOPLE UNDERSTAND WHAT'S AVAILABLE ALL THE MOLECULAR INFORMATION IS IS AVAILABLE AT NO COST TO DOWNLOAD AND PICK MODELS MOST INTERESTING FOR THE PROJECTS. THEY CAN BE VERY INTERESTED IN THE OBTAINING THE MATERIALS AND THEN THEY'RE MORE INTERESTED WHEN THEY FIND OUT IT ONLY COST $250 PER MODEL WHICH ANYBODY WITH A SINGLE RO1 WOULD BE ABLE TO AFFORD. TO FINISH UP WHAT WE'RE DOING TO HELP PROVIDE THESE? MAYBE THE NEXT TIME I HAVE A CHANCE TO SPEAK TO YOU WE'LL HAVE RESULTS BACK THERE THE EFFORT. WE SET THE FIRST 200 MODELS FOR FULL PROTEOMIC ANALYSIS TO THE LABORATORY AT HOPKINS AND EXPECT WITHIN TWO TO THREE MONTHS WE'LL HAVE DATA ONLINE AVAILABLE FOR ANYONE TO USE AND HELP THEM DECIDE WA WHAT TO USE FOR OUR EXPERIMENT AND OUR PANELS ARE BACK ONLINE. I'M SURE ONCE WE PRODUCE THESE AND MAKE THEM VIB AVAILABLE AT LOW COST THERE'LL BE INTEREST IN MAKING THEM AVAILABLE ACROSS DISEASE TO TEST PDX MODELS AND WHAT IS AVAILABLE AT LOW COST.COST THERE'L L BE INTEREST IN MAKING THEM AVAILABLE ACROSS DISEASE TO TEST PDX MODELS AND WHAT IS AVAILABLE AT LOW COST. WE'RE FAR ALONG IN TYPING THE MODELS AND WE STARTED THE PROJECT WITH TEMPEST IN WHICH WE TRIED TO CROSS ANALYZE SOME OF THEIR ORGANOIDS AND IN TERMS OF DRUG TESTING THEY'VE PERFORMED VERSUS OUR SENDING THEIR ORGANOIDS AND THEIR TESTING OUR EXPERIENCE WITH A RANGE OF DRUG TO UNDERSTAND REPRODUCIBILITY OF THE ORGANOIDS AND THEN LOOK AG THE PDXs AND ORGANOIDS TRYING TO UNDERSTAND WHAT DOES AN ORGANOID RESPONSE MEAN IN RESPONSE TO IN VIVO AND LET ME STOP AND ANSWER ANY QUESTIONS YOU HAVE. >> QUESTIONS? [MULTIPLE DISCUSSION] >> EVERY TIME YOU LET ME TALK I GET TO MAKE MY SALES PITCH. ARE THESE MODELS GOING UP ON THE HUM HUMAN TISSUE MODELS. >> THEY'RE ALL FREELY SHARED. IT'S ALL PUBLIC. I THINK THE INITIAL WAY TO DO THIS TO MAKE IT AVAILABLE ON THE WEBSITE AND VICE VERSA SO PEOPLE KNOW THESE THINGS ARE AVAILABLE WHEREVER THEY LOOK. >> THANKS. >> OKAY. SEEING NO OTHER QUESTIONS, WHY DON'T WE MOVE ON. THE NEXT PRESENTATION IS FROM DR. SINGER ON THE STATUS OF SERONET. >> I'LL START WITH APOLOGIZING THERE'S CONSTRUCTION GOING ON NEXT DOOR. SO AS NED MENTIONED AND I THINK YOU ALL RECALL, AT THE END OF APRIL THE PAST PAYCHECK PROTECTION PROGRAM THAT GAVE SUPPLEMENTAL FUNDING TO NCI FOR SEROLOGIC TESTING AND RESEARCH. SHORTLY AFTER THAT IN OUR MEETING LAST MAY I ACTUALLY PRESENTED THIS EXACT SLIDE WHICH WAS THE CONCEPT FOR IMPLEMENTING THAT CONGRESSIONAL MANDATE. AND WE PRESENTED THE NET YORK OF SERRONET AND HAVE TEST AND GRANTS THAT WOULD UNDERTAKE FUNDAMENTAL RESEARCH IN THE IMMUNE RESPONSE TO THE SARS COV2 AS WELL AS THE SEROLOGY LAB AND NETWORK COORDINATING CENTER. THAT WAS A VISION IN MAY AND WANT TO GIVE AN UPDATE OF WHAT HAPPENED SINCE LAST MAY UNTIL LAST WEEK COMMON SERONET WAS OFFICIALLY LAUNCHED. WE GOALS WE SET UP WERE TO INCREASE OUR NATIONAL CAPACITY FOR SEROLOGICAL TESTING AND IN RESPONSE TO SARS COVID-19. THIS IS THE TIME LINE TO GIVE YOU AN IDEA OF HOW QUICKLY THINGS MOVED SINCE WE MET. IF YOU WERE PLANNING TO HAVE REQUEST FOR INFORMATION AND WHAT SERONET SHOULD ENCOMPASS AND THEN THE RFA WAS PUBLISHED FOR THE U54s AND UR1s TO INCORPORATE FEEDBACK FROM THE RFIs AS WELL AS DISCUSSION WITHIN NCI AND THE PARTNER IN THIS. THE RFT FOR THE CAPACITY BUILDING CENTERS WAS PUBLISHED SHORTLY THERAPY. BY ALL OF JUNE ALL THE REQUESTS WERE OUT. PROPOSALS WERE DUE IN JULY. FIRST FOR THE RFA APPLICATIONS AND THEN FOR CONTRACT APPLICATIONS. THEY WERE THEN REVIEWED IN MIDDLE OF AUGUST BY A PANEL AND PRESENTED TO THE SPL IN THE BEGINNING OF SEPTEMBER AND I'M VERY PLEASED TO SAY THAT BY THE END OF SEPTEMBER, ALL OF THE GRANTS AND CONTRACTS WERE AWARDED WITHIN THE FISCAL YEAR 2020. I SHOULD POINT OUT DESPITE THE SHORT TURNAROUND TIME FOR THE APPLICATIONS TO BE PREPARED AND SUBMITTED WE HAD A ROBUST REPRESENTATION. AND SO TOMORROW ACTUALLY IS OUR TI KICKOFF MEETING OF SERONET AND LOOKING FORWARD TO AN EXCITING MEETING. IF ANYONE IS INTERESTED AND LISTENING, LET ME KNOW AND I'D BE HAPPY TO SEND A LINK FOR THAT. WINDCHILL THE OVER ARCHING GOALS WE DEFINED SPECIFIC OBJECTIVES. PRIMARILY TO DEVELOP NOVEL SERRO -- SEROLOGICAL ASSAYS AND WHAT DRIVES THE IMMUNE RESPONSES TO SARS COV2. TO THINK ABOUT AND DETERMINE WHAT FACTORS WHETHER THEY BE GENETIC OR ENVIRONMENTAL MODULATE THE IMMUNE RESPONSE AND THEN TO DETERMINE WHETHER THERE'S SEROLOGICAL CORRELATES AND DISEASE PATHOGENESIS AGAINST FUTURE PROTECTION AND TO IDENTIFY AND ADDRESS BARRIERS TO TESTING. AND WE HAVE EIGHT OF THE CENTERS OF EXCELLENCE AND 13, SEROLOGICAL SCIENCE RESEARCH PROJECTS AND IN ADDITION WE'RE SUPPORTING THE SEROLOGY LAB AND COORDINATING CENTER. AND WE HAVE SOCIO ECONOMIC POPULATIONS GOING TO BE STUDIED AND WE CONSIDERED THAT HAVE USUALLY IN THE SELECTIONS. SO THE SERONET GRANTS NED MENTIONED WILL UNDERTAKE RESEARCH IN THE IMMUNE RESPONSE TO SARS COV2. IN ADDITION THEY'LL ALSO PERFORM SURVEILLANCE STUDIES SO WE'LL HAVE A BETTER IDEA ABOUT THE PREVALENCE AND LONGEVITY IN LONGITUDINAL STUDIES OF SARS COV2. THE U54 GRANTS ARE LISTED HERE. I CAN HAVE THE NEXT SLIDE. THEY'RE COMPLIMENTED BY THE 13UR1 RESEARCH PROJECT. CLEARLY YOU WON'T GET MUCH INFORMATION FROM THESE TWO SLIDES SO IN THE NEXT SLIDE, WE GENERATED A HEAT MAP OF THE KINDS OF AREAS IN INVESTIGATION THAT ARE GOING TO BE UNDERTAKEN BY EACH OF THE GRANTEE INSTITUTIONS AND IT REPRESENTS SPECTRUM OF THE RESEARCH THAT'S GOING TO BE DONE THEY INCLUDE THE IMMUNE RESPONSE CHARACTERIZATION AND THE IMMUNE RESPONSE TO A NATIONAL INFECTION VERSUS THAT TO VACCINATION AND HOW THEY DIFFER. THE RELATIONSHIPS BETWEEN COVID-19 AND CANCER. CANCER THERAPY AND OTHER COMORBIDITIES, HOW THEY INTERACT. OF COURSE I MENTIONED SOCIAL DETERMINATES AND ACCESS TO CARE. FOR CAPACITY-BUILDING CENTERS I LISTED HERE. THEY'LL DEVELOP AND EXPAND SEROLOGICAL TESTING IN THE COMMUNITY AND CREATE STANDARD FOR ASSAY DEVELOPMENT AND SURVEILLANCE STUDIES. THE SEROLOGY LAB KNWILL PLAY A CRITICAL ROLE WITH SERUM AND BLOOD SAMPLES FROM COVID PATIENTS AND CONTROLS. THESE ARE GOING TO BE USED TO DEVELOP ASSAY STANDARDS FOR QUALIFYING ASSAYS AND THE LAB IMPORTANTLY IS GOING TO SHARE ASSAYS ACROSS THE THREAT WORK. -- NETWORK. OF COURSE THE COORDINATING CENTER WHICH IS ALSO HOUSED HERE IS GOING TO BE RESPONSIBLE REALLY FOR MANAGING ALL ASPECTS SERONET COORDINATION AND STEERING OF OUTREACH AND ETCETERA. SO SERONET IS DESIGNED TO BE A HIGHLY INTERACTIVE NETWORK WITH THE IDEA THAT IT WILL SHARE ALL DATA AND AGENT ACROSS THE NETWORK AND MORE BROADLY ACROSS THE COMMUNITY. WE ALSO HAVE SET ASIDE 10% OF THE GRANT WARDS TO BE USED FOR TRANS NETWORK COLLABORATIVE PROJECTS AVAILABLE IN THE SECOND YEAR OF FUNDING AND AGAIN TO PROMOTE THE IDEA OF COLLABORATION AND JOINING OF IDEAS AND INFORMATION. ADDITION ALL THE SERONET FUNDED APPLICATIONS ARE REQUIRED FOR THE ACCESS AND DATA AND RESOURCES TO BE IMMEDIATELY AVAILABLE UPON PUBLICATION. THE NEXT SLIDE, PLEASE SUMMARIZES THE BUDGETS WE ALLOCATED TO EACH OF THE COMPONENTS. I'M SHOWING FOR THE FIRST YEAR AND FOR THE TOTAL PROJECTED FIVE YEARS BUT I DID WANT TO POINT OUT THAT GIVEN THE VERY RAPID CHANGES IN THE LANDSCAPE OF COVID-19 WE'RE GOING TO DO AN EVALUATION AND ASSESSMENT AFTER TWO YEARS OF FUNDING TO DETERMINE WHETHER WE NEED TO CHANGE COURSE IN THESE GRANTS, HOW WE CAN RESPOND TO THE SITUATION IT'S IT'S GOING TO PRESENT ITSELF IN TWO YEARS. AND IN THE LAST SLIDE, I REALLY WANT TO EMPHASIZE HOW MUCH TIME AND EFFORT WENT IN TO ESTABLISHING SERONET WITH THIS AGGRESSIVE TIME LINE AND WANT TO THANK THOSE WHO WORKED TIRELESS TO GET THE RFAs WRITTEN AND GET EVERYTHING DONE AND READY TO HAVE A KICKOFF TOMORROW. I ALSO REALLY NEED TO THANK PAULETTE AND HER TEAM FOR PULLING UP ALL THE STOPS TO GET THE GRANTS DONE AND FOR THOSE WHO MADE SURE ALL THE GRANTS GOT DONE BY THE END OF SEPTEMBER. IT COULDN'T BE DONE WITHOUT THE GREAT TEAM AT CI AND I APPRECIATE THEIR EFFORTS. WITH THAT I'M HAPPY TO TAKE QUESTIONS. >> THANK YOU. IT SOUNDS LIKE AN EXCITING INITIATIVE. WE LOOK FORWARD TO SEEING HOW IT UNFOLD. WE HAVE TIME FOR QUESTIONS. >> THIS IS RAY. I HAVE A COMMENT AND I HEARD A COUPLE OF YOUR PRESENTATIONS NOW SO THIS IS REALLY REMARKABLE TO BE ABLE TO GET THIS MUCH WORK DONE AND THIS MUCH FUNDING OUT SO QUICKLY. I DON'T THINK IT'S HAPPENED IN MY HISTORY OF WORKING WITH A GOVERNMENT AGENCY. IT'S QUITE REMARKABLE. >> IT WAS EVERY COMPONENT CONTRIBUTING TO MAKE SURE IT GOT DONE. IT INVOLVES NOVEL AND NIMBLE CONTRACTING WHICH IS ONE OF THE REAL IMPORTANT FEATURES OF FREDERICK NATIONAL INVOLVING ACQUISITIONS WHICH WORKS AT BREAK NECK PACE FOR THIS AND GRATEFUL FOR THEIR WORK AS WELL. >> OKAY. GREAT. SO THE NEXT PRESENTATION THANKS, DEANNA IS FROM FRANK McCORMICK ON THE RAS INITIATIVE PROGRESS REPORT. FRANK. >> I'M HERE TO GIVE YOU AN UPDATE ON THE RAS INITIATIVE. I'D LIKE TO START BY REMINDING YOU OUR PRIMARY GOALS IS ARE TO FUND NEW COMPOUNDS AND NEW DRUGS THAT BIND DIRECTLY TO THE K-RAS PROTEIN. ALL INTERACTIONS WITH THE EFFECTERS OF KINASE. WE WANT TO GO AT THE PROTEIN ITSELF AND ADVANCING PATHWAYS AND DISSECTING THOSE PATHWAYS WAS THE PURVIEW OF THE RESEARCH COMMUNITY AND PHARMACOMPANIES TO DEVELOP THE INHIBITERS OF THE DOWN STREAM KINASE AND HAVE EFFORTS TO UNDERSTAND MORE ABOUT THE COMPLEX NETWORK INCLUDING THE NETWORK AND WE HAVE A ROLE IN IT TOGETHER. THE SECOND GOAL IS TO TRY TO UNDERSTAND AT THE MOLECULAR LEVEL HOW RAS PROTEINS INTERACT WITH THE PLASMA PROTEIN AND INTERACT. A LOT OF THE WORK IS COLLABORATION BETWEEN THE NCI AND DEPARTMENT OF ENERGY AND FOUR NATIONAL LABS WHICH BASICALLY EMPLOYED THE MOST HIGH TECH COMPUTATIONAL METHODS AND CHEMICAL METHODS TO ADDRESS THE PROBLEM AND WE'VE DONE WORK ON THE PROJECT. THERE'S AN EFFORT TO UNDERSTAND HOW KRAS PROTEINS INTERACT WITH THE PROTEIN MEMBRANE. THIS SUMMARIZES SOME APPROACHES WE USED TO ANALYZE HOW THEY INTERACT WITH THE PLASMA MEMBRANE. THE OVERALL RATIONALE IS HOW THEY INTERACT WITH THE MEMBRANE TO COME UP WITH NEW STRATEGIES BASED ON THE DISCOVERIES IN THE FUTURE. THIS SUMMARIZES SOME OF THE PROPERTIES AND ON THE NEXT SLIDE SUMMARIZES SOME OF THE COMPUTATIONAL MACHINE LEARNING ASPECTS OF THE PROJECTS. IT'S AN ITERATIVE PROCESS WHERE WE LOOK AT PROPERTIES OF THE KRAS PROPERTIES AND FEED IT IN AND MAKE PREDICTIONS AND COME BACK TO THE LAB AND TEST THEM AND THEY HELP INFORM BETTER MODELS. THIS HAS BEEN A PRODUCTIVE AND EXCITING INTERACTION AND THIS SUMMARIZES METRICS RELATING TO SOME OF THE OUTREACH EFFORTS AND SOME COLLABORATIONS. AND THIS HAS BECOME A DIRECT DISCOVERY COMPONENT WITHIN THE INITIATIVE AND I'LL DISCUSS IT IN MORE DETAIL IN A MOMENT. THE NEXT SLIDE SUMMARIZES SOME OF THE PAPERS WE PUBLISHED OVER LAST YEAR FROM INTERNAL AND COLLABORATIVE EFFORTS AND THERE'S A COLLABORATIVE EFFORT. AND TRYING TO IDENTIFY THE KRAS AND G12R WHICH HAS UNUSUAL PROPERTIES AND COLLABORATED WITH A BIOLOGY GROUP AT FREDERICK TO GET CRYSTAL STRUCTURES OF THE PROTEIN TO UNDERSTAND WHY THIS PROTEIN HAS THESE PROPERTIES. THAT'S ONE EXAMPLE OF A COLLABORATION WHICH HAS BEEN VERY FRUITFUL. THESE ARE SOME OF THE PEOPLE WE'VE HAD PRODUCTIVE RELATIONSHIPS WITH AND I HAVE MORE DETAIL ON HOW THEY FUNCTION AND THEY INTERACT WITH THE COMMUNITY AND THEY'VE BEEN SUCCESSFUL SO FAR IN PRODUCTIVE COLLABORATIONS. LESS LIKELY IS THE PROJECT WHICH IS ESSENTIALLY A COMPANY MOST OF THE WORK DONE BY THIS TEAM AND THEY HAVE 12 FTEs PER YEAR AND WE COLLABORATE WITH UA AND NATIONAL LABS AND LONDON AND ONE IS IS A TREATMENT FOR NF LUNG DISEASE AND HAVE DONE CLINICAL WORK AT THE NCI. THEY'VE AND THE LEFT YOU WILL ILLUSTRATES BLOCKING THE KRAS PROTEIN. AND NATIONAL PART IN RAS BIOLOGY. WE DEVELOPED COMPOUNDS WHICH ARE ON TARGET AND ACTIVE IN CELLS AND WE HAVE MANUSCRIPTS DESCRIBE THE WORK. WE LOOK AT KRAS WHICH IS UNIQUE TO THE KRAS PROTEIN NOT FOUND AND AN INTERESTING PART OF THE PROTEIN CLOSE TO WHERE THE ACTION IS WITH THE BINDING REGIONS AND CLOSE TO THE PROPERTIES. WE THINK THE COMPOUNDS WILL EITHER BE GREAT AND SPECIFIC BECAUSE AGAIN THIS RESIDUE IS IN COLLABORATION WITH FNL. THE THIRD PROJECT WE HAVEN'T DISCUSSED WITH THE GROUP BEFORE A NEW PROJECT IT ATTACKED THE KINASE AND IF YOU USE THE BREAK OF THE INTERACTION IN AN EXISTING ANIMAL WITH THE TUMORS THE TUMORS ARE REGRESSED. WE THINK BLOCKING KRAS WIN -- WITH THE KINASE IS A GOOD IDEA AND WE HAVE COMPOUNDS THAT COMBINED AND PREVENT KRAS BINDING AND ONLY KRAS CAN BIND TO KINASE. THIS HAS NOW BECOME OUR LEAD PROJECT NOW AND WE HAVE COMPOUNDS ACTIVE IN CELLS AND MAYBE TENFOLD FROM BEING PRE CLINICAL DEVELOPMENT COMPOUNDS. NEXT SLIDE PLEASE AND WE'LL HAVE ANALYSIS OF THE KINASE BASED ON THE STRUCTURAL BIOLOGY DONE IN THE GROUP AND SO IT SHOWS THE STRUCTURE OF THE RAS KINASE AND YOU SEE THE LAST DOMAIN AND CHARACTERIZED MANY YEARS AND CRYSTALLIZED. THE IMPORTANCE OF THIS HAS BEEN RECOGNIZED BY THE RESEARCH FIELD FOR MANY YEARS AND THERE'S A PAPER THAT SHOWS CLAIMS OF THE DOMAIN IS ESSENTIAL FOR RAS ACTIVATION. AND THIS AND SEVERAL OTHER PAPERS INCLUDING DEBBIE LARSSON WHO'S BEEN A LEADER IN THE FIELD SHOWS IT'S ESSENTIAL FOR PARTICIPATING IN BINDING TO RAS SO YOU SEE THE ACTIVATION PROCESS FROM THE BINDING PROCESS. SO BY WHICH IT CONTRIBUTES TO THE ACTIVATION IS COMPLICATED. ON THE RIGHT HAND PANEL IS A DIAGRAM SHOWING STEPS INVOLVED IN THE ACTIVATION OF RAF AND IN THE RED CIRCLE YOU MAY SEE IT HANG FROM THE MEMBRANE. AND THIS HAS BEEN PART OF THE PROTEIN WE NOW HAVE FOR THE FIRST TIME A CRYSTAL STRUCTURE OF THE CRL REGION WHICH INCLUDES THE CLD TOGETHER SHOWN ON THE LEFT SIDE. THERE'S TWO REPRESENTATIONS HERE AND YOU CAN SEE THE RAS BIND DOMAIN IN BLUE AND THE RICH DOMAIN IS IN GREEN. SURPRISINGLY THE TWO REGIONS FORM A MORE OR LESS CONTINUOUS DOMAIN AND HAVE A BIGGER FOOTPRINT ON THE RAS THAN PREVIOUSLY APPRECIATED. THE RIGHT HAND PANEL IS THE FOOTPRINT THAT THE REGIONAL GRAPH MAKES ON KRAS AND THE CRD CONTRIBUTES ALMOST AS MUCH AS THE WELL KNOWN RBD. THIS IS A NEW INSIGHT. THE RAF PROTEIN BINDS DIFFERENTLY THAN EXPECTED TO AN ADDITIONAL PATH. AND THE PERFORMANCE-ENHANCING IT MAKES IS THE CONTRIBUTION IT MAKE IS RATHER SMALL AND THE RAS BINDING DOMAIN BINDS AND THE COMBINED CRB IS TWO-THIRD MORE EFFECTIVE IN BINDING. IT DOES CONTRIBUTE SOME BINDING ENERGY BUT NOTHING LIKE THE RBD. AND FROM A DISCOVERY IT'S BEEN IMPOSSIBLE TO FIND SMALL MOLECULE DRUGS THAT BIND BECAUSE THE AFFINITY IS SO HIGH AND WE THINK WHAT'S TECHNOLOGICALLY POSSIBLE TO THE BINDING WITH SMALL MOLECULES BECAUSE THE INTERACTION IS MUCH LESS STRONG. AND THE INTERACTION IS LIKELY TO EFFECT INTERACTION OF RAF AS DESCRIBED IN THE PREVIOUS SLIDES. THIS PRESENTS A NEW OPPORTUNITIES FOR THE RAF 1 IS DIFFERENT TO THE REGION OF OTHER MEMBERS OF THE RAF FAMILY. WE HAVE SEVERAL APPROACHES AND COMBINED COMPOUNDS THAT BIND TO THE CRD AND PREVENTS BINDING WITH KRAS AND COMPOUNDS THAT EFFECT THE CONFIRMATION OF THE COMPLEX. AND PERHAPS EFFECT AND PROVIDE THE APPROACH. WE HAVE SEVERAL INTERNAL EFFORTS TO DISRUPT THE ACTION AND OTHER APPROACHES BUT WE ALSO HAVE METHODS AND TECHNOLOGIES. THIS WAS IN APRIL AND INVOLVES A LOT OF WORK EN THIS CASE THE WORK WILL BE DONE WITH OVERSIGHT FROM THE GROUP OF FREDERICK AND STRUCTURAL BIOLOGY AND CHEMICAL GUIDANCE. THE LEG WORK WILL BE DONE AND SCREENING AT SANOFI. IT'S A DIFFERENT RELATIONSHIP THAN ONE DESCRIBED PREVIOUSLY. WE HAVE A GREAT RELATIONSHIP WITH RESEARCHERS THERE AND CAN LEAD TO NEW PROPERTIES. THIS IS OUR MODEL HOW WE THINK KRAS RECRUITS RAF PRODUCT TO PLASMA MEMBRANE. IT'S IT RECRUITS THE CRD COMPLEX AND CAUSES INTERACTION AND MOST LIKELY POSITIONING IN THE MEMBRANE THROUGH THE INTERACTION SETS OFF THE KINASE WITH THE DIMERIZATION SENSE AND ACTIVATION. WE THINK DISRUPTING DIFFERENT ANGLES AND ASPECTS OF RBD COULD BREAK OPEN THIS CHAIN OF EVENTS AND PREVENT ACTIVATING RAF EFFICIENTLY. NOW AN INTERNAL EFFORT A BIG TEAM EFFORT AND THEY HAVE RESIDUE ON THE RAS PROTEIN AND REPLACED EACH RESIDUES WITH EXISTING RESIDUE. WE HAVE MUTANT PROTEINS EACH AT A DIFFERENT POSITION AND MEASURES IT USING CHEMICAL METHODS AND WE HAVE A CLEAR VIEW OF WHAT IT LOOKS LIKE. AND WE INTEND TO USE THEM ONE AT A TIME TO WORK ACROSS THE SURFACE AND TRY TO FIND MOLECULES THAT BIND. THIS IS BASED ON THE WORK OF OTHERS AND THE WORK IS SHOWN IN THE DIAGRAM AND THERE'S A COMPOUND FROM THIS AND BINDS AND RUNS AROUND THE SURFACE UNTIL IT FINDS A POCKET AND STAYS THERE AND WITH EACH ACTS LIKE A TETHER AND NEW POCKETS FOR MOLECULE BIND. AN THEY'VE BUILT A NEW VERSION MANY YEARS AGO AND THERE'S COMPUTATIONAL METHODS FOR WHAT WE HOPE WILL BE AN IMPROVED VERSION OF THE LIBRARY WE'VE OPTIMIZED THE LIBRARY AND HAVE IT AGAINST EACH MUTATIONS ON THE RAS PROTEIN. THE NEXT SLIDE SUMMARIZES WHERE WE ARE AND EACH RESIDUE REPRESENTS THE SUCCESSFUL COMPLETED SCREENING PROGRAM WHERE THE PARTICULAR RESIDUES IS THEN SCREENED ACROSS THE LIBRARY OF SOME 2000 PLUS SMALL MOLECULES AND THIS IS GOING TO GENERATE AN ENORMOUS AMOUNT OF DATA. IT'S A NICE PICTURE AND IT'S INDUCED IN THE MOLECULES THAT BIND TO THE SURFACE AND THERE'S A MARKING OF THE KRAS SURFACE USING THIS CHEMICAL PROBE TECHNIQUE AND WE'VE COME ACROSS INTERESTING ONE THAT STANDS OUT THIS PARTICULAR PROTEIN IS THE C MUTANT OF KRAS. AND THIS SHOWS INTERESTING PROMISING CLINICAL DATA IN HUNG CELL CARCINOMA AND THE APPROACH WORKS ON THE GDP KRAS THERE'S A POCKET WHERE IT'S EXPOSED WITH THE KRAS PROTEIN. THIS MEANS CANCER CELLS CAN MOVE THE PROTEIN MORE TO THE GTP STATE AND MAKING THE PROTEIN LESS ACCESSIBLE TO THE INHIBITERS. AND THE COMBINATIONS ARE CERTAINLY BEING TESTED AS WE SPEAK. I THINK MOST WOULD AGREE THE COMPOUND THAT BINE TO THE G12C PROTEIN WOULD BE A NICE ADDITION TO THE PIPELINE. THIS IS AN EXAMPLE THAT HELPED IN THE FORM. AND THE GROUP HAS DONE STRUCTURAL BIOLOGY ON THIS USING RNR AND THIS PARTICULAR COMPOUND BINDS AND THIS COULD BE ON THE STARTING POINT OF A NEW PROGRAM WHICH COULD LEAD HOPEFULLY TO POINTS AND THERE'S OUTREACH TO A LIST OF COMPANIES IN THE PHARMAI PHARMAION -- PHARMABIO TECH WORLD AND LOOKING AT THE KRAS. SO WE HAVE GREAT BIOLOGISTS. THE GOALS OF THE SYSTEM OF THE PROJECT ARE TO BASICALLY FIND NEW POCKETS AND OPTIMIZING USING COMPOUNDS THAT BIND TO THESE NEW POCKETS. THIS WILL BE USING ENHANCEMENT AS WELL AS THE ONES WHICH ARE OBVIOUS. THIS EFFORT IS WELL UNDERWAY AND THE EXAMPLE PROVIDES NEW LEADS WE AND OTHERS CAN TAKE FORWARD TO TRY TO DEVELOP TO POTENTIAL NEW THERAPIES IN THE FUTURE AND WITH THAT I'LL STOP AND BE DELIGHTED TO ANSWER QUESTIONS. >> THANKS A LOT, FRANK. LOTS OF DATA THERE. WE SHOULD HAVE GOOD DISCUSSION. LET ME START. I'VE ALWAYS BEEN INTRIGUED BY THE H95 SITE BECAUSE OF THAT SELECTI SELECTIST -- SELECTIVITY FOR KRAS AND INCREASE THE TURNOVER OF THE PROTEIN. >> WE HAVE A COMPOUND AND IT RESULTED IN DEGRADATION OF THE PROTEIN. WHETHER THERE WAS A PROPERTY OF IT BEING PART OF OTHER COMPOUNDS WE DON'T KNOW YET. WE'RE MAKING PROGRESS BUT IT'S HARD. IT'S HARD ON TWO FRONTS. ONE THERE'S FEW COMPOUNDS THAT AND IT'S LIMITED SO THE CHEMISTRY OF ATTACKING IT IS A BIG CHALLENGE. WE ARE HELPING THE PROCESS OF ACTIVATION OF SB95. WE HAVE COMPOUNDS THAT DO BIND AND WE'RE IN THE PROCESS OF MAKING THE BINDING CONSTANT. IT'S A HARD PROJECT BUT WE THINK THE REWARD IS SUFFICIENT TO JUSTIFY THE EFFORT IT'S TAKING. WE THINK THIS IS THE CHEMISTRY AND THE WORK IS TOUGH. >> GREAT. >> YOU HAVE A RELATIVELY SMALL LIBRARY WITH YOUR COMPOUNDS AND PROBING ALL SWORD OF POTENTIAL POTENTIAL -- ALL POTENTIAL SITE. CAN YOU ANTICIPATE THE POCK SOMEHOW? -- THE POCKET SOMEHOW? >> IT'S OPTIMIZED FOR A RANGE OF PHYSICAL AND CHEMICAL PROPERTIES. THE GENERAL CONCEPT IS THE INITIAL HIT IS GOING TO BE LOW AFFINITY TETHERED. THAT'S THE APPROACH THAT LED TO THE COMPOUNDS. >> AND FROM THE PHARMACOLOGIC SIDE. >> AND SOME PROPERTIES INVOLVE THE CHEMICALS AND THE CHARGE AND THE POTENTIAL FOR MAKING IT BETTER COMPOUNDS. AND USING THIS TO REPRESENT ALL THE MAJOR CHARACTERISTIC OF THE POTENTIAL COMPOUND. THE COMPOUNDS ARE SCREENED USING MASS SPEC. THERE'S A HIGH THROUGHPUT SYSTEM SOME ARE LIMITED BY THE THROUGHPUT. WE'RE LOOKING AT WHETHER IT'S INDUCED OR THROUGH THE POCKET AND USING MULTIPLE HITS AROUND THAT PARTICULAR POCKET. >> IT'S A FASCINATING APPROACH. I HAVE A LOT OF QUESTIONS. >> OKAY. OTHERS? >> AND YOU GAVE US DIFFERENT APPROACHES. IT'S GOOD TO SEE SO MUCH OUTSOURCING OF THE CHEMISTRY. I KNOW THERE'S A SMALL GROUP AT FREDERICK BUT IT'S PRACTICALLY WITH A NUMBER OF APPROACHES YOU'RE USING IT'S GREAT TO USE SO MANY DIFFERENT APPROACHES FROM A CHEMICAL POINT OF VIEW. >> THANKS FOR HELPING KEEP THE PROCESS GOING THROUGH COVID-19 BECAUSE SOME WORK HAS BEEN DONE OFF SITE AND HAVE BEEN ABLE TO KEEP GOING DESPITE ALL THE CONCERNS. >> THAT'S GREAT. TERRIFIC. OKAY. WE'LL WE'RE NEAR THE BREAK I WANT TO TURN IT BACK TO NED FOR A SECOND. >> SURE. THANK YOU. I INTRODUCED DR. DENISE MONTEL. SHE'S ON OUR BOARD OF SCIENTIFIC COUNSELORS AND THE PROFESSOR IN THE DEPARTMENT OF MOLECULAR CELLULAR BIOLOGY AT UNIVERSITY CALIFORNIA SANTA BARBARA. AND SHE HAS SERVED ON THE ADVISORY COUNCIL OF AMERICAN CANCER SOCIETY AND NATIONAL INSTITUTE OF JOURNAL AMERICAN S AND EARNED HER Ph.D. IN NEUROSCIENCE AT STANFORD AND THANK YOU FOR JOINING US AND DOING THIS AND WELCOME. WELL, I'VE DONE MY JOB OF KEEPING US ON TIME TOO WELL SO WE'RE FIVE MINUTES EARLY. SO WE'RE SCHEDULED FOR A BREAK RIGHT NOW SO WHY DON'T WE TAKE IT TO THE 3:00 EASTERN INSTEAD OF 3:05 IF THAT'S OKAY WITH EVERYBODY AND WE'LL SEE YOU BACK IN 15 MINUTES. >> WELCOME BACK, EVERYBODY. IT'S A REAL PLEASURE TO WELCOME JOE GRAY WHO IS GOING TO GIVE A REPORT ON THE NCI TASK FORCE TO EVALUATE THE NCI COLLABORATION FOR THE NEWCOMERS ON THE COMMITTEE, JOE WAS THE CHAIR OF THIS COMMITTEE BEFORE ME AND IT'S GREAT TO SEE HIM AGAIN AND THANK HIM FOR HIS SERVICE TO THE NCI AND IT FNLAC. JOE, TAKE IT AWAY. >> GOOD TO BE BACK, SO TO SPEAK. LET ME LAUNCH IN TO THE PRESENTATION. WHAT I'LL TRY TO DO TODAY IS TELL YOU WHAT WE'VE BEEN UP TO THE LAST FEW MONTHS. I'LL TALK ABOUT THE CHARGE WE GOT FOR THE TASK FORCE AND TALK YOU ABOUT THE NATURE AND THE PROCESS WE WENT THROUGH IN THE VALUATION -- EVALUATION AND HOW WE EVALUATED THE PILOT PROJECTS AND THE MANAGEMENT OVERALL AND CONCLUDE WITH A COUPLE LESSONS WE THINK WE LEARNED FROM THIS PROFESSOR. THE CHARGE WAS TO CONDUCT AN IN DEPTH VIEW OF THE PROGRAM AND EVALUATION OF PROJECTS AND MAKE RECOMMENDATIONS. IN PARTICULAR AS TO WHETHER OR NOT THE COLLABORATION CAN CONTINUE AND TO COMMENT TO THE EXTENT ON WHICH THE HIGH-PERFORM COMPUTING CAPABILITIES UNIQUE TO LABORATORIES WERE IMPORTANT IN THE WHOLE PROCESS. THE TEAM INCLUDES SEVERAL IN THE ROOM AND I ENTRUST WILL WEIGH IN TO KEY ME HONEST ON ALL THIS AND I SERVED AS THE CHAIR AND I HAVE TO SAY THAT THIS IS ONE OF THE MOST DYNAMIC AND INTERACTIVE TASK FORCES I'VE BEEN INVOLVED WITH EVERYBODY HAD A LOT TO SAY WITH THE PROJECTS AND THE REPORT REFLECTS CRITICAL THINKING IN THE WHOLE ENTERPRISE. THE PROGRAM WE ARE TRYING TO EVALUATE AND ADVANCED REPORTING SOLUTIONS FOR CANCER WAS INTENDED TO BE A FIVE-YEAR PROJECT AND THE IDEA WAS IT WAS GOING BRING TO BEAR THE UNIQUE HIGH-PERFORMANCE XUTH -- COMPUTING TECHNOLOGIES AND BRING THOSE TO BEAR ON PROBLEMS AT THE NATIONAL CANCER INSTITUTE. IT WAS DIVIDED IN TO THREE AREAS AGAIN THIS IS A PILOT PROJECT SO THE IDEA WAS TO TEST WHERE IT WOULD BE DEPLOYED. WE WANTED TO UNDERSTAND CANCER BIOLOGY PRIMARILY THROUGH SIMULATIONS, MOLECULAR DYNAMICS AND SO ON AND TO IDENTIFY NEXT GENERATION TREATMENT OPTIONS AND THIS IS MOSTLY PREDICTIVE ONCOLOGY AND TRYING TO FIGURE OUT HOW TO LOOK AT THE PROTEOMICS OF CELLS AND TISSUES AND RESPOND TO TREATMENT AND ALSO TRANSFORM CANCER CARE BY IMPLYING THINGS LIKE NATURAL LANGUAGE AND THE MISSION. THERE WERE THREE SPECIFIC PILOT PROJECTS. A CELLULAR LEVEL PILOT PROJECT DESIGNED TO DEVELOP PREDICTIVE COMPUTATIONAL MODELS OF CANCER THERAPEUTICS. THIS IS AVAILABLE THROUGH THE NCI PROGRAMS AND THERE WAS A MOLECULAR LEVEL PILOT AIMED AT TRYING TO HELP US BETTER CHARACTERIZE RAS MEMBRANE BIOLOGY PRIMARILY THROUGH SIMULATIONS AND THEN A POPULATION LEVEL PILOT PROJECT WHICH WAS TO INTEGRATE AND ANALYZE CANCER SURVEILLANCE DATA. THERE ARE PART OF THE PROGRAMS AIMED AT UNCERTAINTY QUANTIFICATION AND WHETHER PROJECTS AND WE CONSIDERED THOSE TO BE OUTSIDE THE SCOPE OF THIS EVALUATION AND SO WE HAVE ANYTHING TO SAY ABOUT THAT IS LEFT TO A DIFFERENT GROUP. THE EVALUATION PROCESS WE HAD SIX VIRTUAL REALITY MEETINGS, JULY THROUGH OCTOBER. DURING THE MEETINGS WE DEVELOPED AND DISCUSSED WHAT THE EVALUATION QUESTIONS WOULD BE. AND THEN WE RECEIVED PRESENTATIONS PRIMARILY FROM THE NCI LEADS FOR EACH OF THE PILOT PROJECTS. THE REVIEW TEAM WAS DIVIDED INTO GROUPS AND THE SUBGROUPS EVALUATED EACH PROJECT INDIVIDUALLY. WE'LL TALK ABOUT THAT AND WE ALSO CONSIDERED THE ALLOVER NCI MANAGEMENT AND HAD THINGS TO SAY ABOUT THAT. AS FAR AS THE EVALUATION QUESTIONS WE FOCUSSED ON DURING THE COURSE OF THIS REVIEW. ONE WAS THE IMPACT OF THE COLLABORATION OVERALL PILOTS SPECIFICALLY AND WHAT IMPACT DID THIS HAVE ON THE LARGER CANCER RESEARCH. WE ASKED HOW THE UNIQUE COMPUTATING CAPABILITIES WOULD CONTRIBUTE TO CANCER RESEARCH. AND IT ENGAGED THE GREATER CANCER COMMUNITY AND HOW THEY BENEFIT. WE SPENT TIME TALKING ABOUT ADDITIONAL RESEARCH OPPORTUNITIES FOR COLLABORATION THAT MAY BE BROUGHT TO BEAR AND FINALLY ASKED WHETHER THE NCI OVERSIGHT SHOULD THE NCI CONTINUE TO SUPPORT THE COLLABORATION. ASSESSMENT OF PILOT ONE TO HELP DEVELOP PREDICTIVE MODELS FOR DRUG RESPONSE. I THINK THE GENERAL CONCLUSION WAS THIS WAS A LAUDABLE GOAL. IT'S IMPORTANT. I THINK THE GENERAL COMPOSITE -- CONSENSUS WAS THIS WAS LAUNCHED PREMATURE AND THE DATA FOR THE COMPUTATIONAL ACTIVITIES WASN'T AVAILABLE AT THE TIME THE PROJECT STARTED. IS THE GROUP HAD TO REACH OUT TO THE COMMUNITY TO GATHER OTHER DATA SETS FOR THEIR ACTIVITIES AND DATA SETS THAT WERE ALREADY WELL WORKED OVER. IT WASN'T OPTIMAL FROM THAT PERSPECTIVE. THE OTHER THING WE CONCLUDED WAS THAT THE ACTIVITIES WERE PRIMARILY COMPUTATIONAL WITHOUT CONSIDERING THE UNDERLYING BIOLOGICAL CONSTRAINTS. WE DIDN'T THINK BECAUSE THIS THING WAS SPUN OFF SO QUICKLY IT HAD APPROPRIATE AND ONGOING NCI MANAGEMENT OVERSIGHT AND ENGAGEMENT. AGGREGATED DATA SETS SHOULD HAVE BEEN ORGANIZE WILL BUT BECAUSE OF THE PREMATURE LAUNCHING OF THIS AND LACK OF APPROPRIATE DATA TO SUPPORT THE COLLABORATION, WE FELT THIS SHOULD BE RETHOUGHT BUT TO DATE PRODUCTIVITY HASN'T BEEN COMMENSURATE WITH THE INVESTMENT. THIS IS ONE THAT NEEDS TO BE [INDISCERNIBLE] THE PILOT PROJECT TWO IS REALLY AIMED AT THE RAS INITIATIVE OUT OF FREDERICK AND THE IDEA WAS TO USE COMPUTATIONAL CAPABILITIES TO PROVIDE INSIGHT IN TO RAS EXISTING INTERACTIONS. WE THOUGHT THE ENGAGEMENT WAS GOOD WITH FREDERICK. THIS IS IS ONE OF THE THREE PROGRAMS THAT LEVERAGED THE HIGH COMPUTING CAPABILITIES APPROPRIATELY. THE PRODUCTIVITY WAS OKAY. THAT WASN'T A COMPLETE INTEGRATION OF THE MODELLING IN TO THE EXPERIMENTAL COMMUNITY. ONE OF THE THINGS THAT WAS LACKING WAS EXPERIMENTAL VALIDATION OF THE COMPUTATIONAL MODELS. A COROLLARY TO THAT THE COLLABORATION WASN'T AS GOOD AS IT COULD HAVE BEEN. THERE'S AN AREA FOR IMPROVEMENT THERE. AND THE WE FELT IT SHOULD CONTINUE AND IT MAKES USE OF HARDWARE AND COMPUTATIONAL CAPABILITIES AND NEEDS MORE FOCUS ON MODELS AND EXPERIMENTAL VALIDATION AND EFFORTS ON COMMUNITY ENGAGEMENT. AND TO GET THE SEAR DATA GATHNG -- SEER DATA GATHERING CENTER HAD A PROCESSING EXERCISE AND THIS IT LOOKED AT EXPERTISE AND COULD HAVE BEEN IMPROVED AS ALL THINGS COULD HAVE BEEN. SO FAR THE ACTIVITIES BECAUSE OF THE WAYS DATA ARE ORGANIZED DIFFERENTLY BETWEEN SEER AND ELSEWHERE IN THE CANCER COMMUNITY WE THOUGHT THERE WERE PROBABLY SOME APPROACHES HAD LIMITED UTILITY BEYOND SEER BUT NONETHELESS IT WAS EFFECTIVE IN THE SEER RAM AND WE THOUGHT THE PILOT SHOULD CONTINUE WITH STRONGER FOCUS ON IMPLEMENTATION AND TRYING TO FIGURE OUT HOW TO ENGAGE COMMUNITIES BEYOND THE SEER PROGRAM. THIS IS ONE WHERE WE THOUGHT THE FUTURE SHOULD BE INFORMED BY AN ADVISORY GROUP THAT DIDN'T SEEM TO EXIST AT THIS POINT. OVERALL MANAGEMENT OF THE COLLABORATION? WE DID FEEL THIS COULD HAVE BEEN STRONGER IN ALMOST ALL CASES, FRANKLY. THE PILOT CAME AND THE SEER REGISTRY TEAM WAS A GOOD EXAMPLE OF A SUCCESSFUL COLLABORATION. IT WORKED FROM THE TIME TO DATA ENTRY INTO THE REGISTRY WAS DRAMATICALLY REDUCED AS A RESULT OF THIS AND THAT WAS A REALLY GOOD OUTCOME. COWL BE THAT ALL THE PROJECTS COULD BE MOVED BY INTERACTING WITH THE PROGRAM STAFF AT THE NCI IN THE EXTRAMURAL DIVISIONS THE RESEARCH DRIVEN PORTFOLIO IS. ALL THREE OF THESE PILOT PROJECTS TENDED TO BE A LITTLE BIT INSULAR AND NOT ADEQUATELY ENGAGED WITH THE EXTERNAL COMMUNITY AND THOUGHT GETTING THEM OUT OF FREDERICK AND INTO THE NCI EXTRAMURAL DIVISION STAFF WOULD BE AN APPROPRIATE THING TO DO. AS A CONSEQUENCE OF THAT AND THE NATURE OF THIS, THE EXTRAMURAL COMMUNITY IN GENERAL IS NOT PROPERLY ENGAGED. THIS LED TO A LOT OF MISSED OPPORTUNITIES TO LEVERAGE EXISTING KNOWLEDGE AND AMPLIFY THE IMPACT ON THE CANCER RESEARCH. THERE'S A LOT OF ACTIVITY GOING ON IN THE BIOLOGY COMMUNITIES AND MANY OTHER PROGRAMS AND THE EXTRAMURAL COMMUNITY AIMED AT DEVELOPING PREDICTIVE MODELS AND THOSE WEREN'T ENGAGED AT ALL. WE FOUND THEY WERE DRIVEN AND STEMMING FROM THE FACT COMPUTATIONAL ACTIVITIES WEREN'T AS WELL CONNECTED TO THE APPROPRIATE BIOLOGICAL COMMUNITIES AS THEY SHOULD BE AND PROVIDED A MECHANISM FOR THE EXTRAMURAL COMMUNITY TO COLLABORATE WITH NCI IN THE VENTURE. SO LESSONS LEARNED. I THINK WELL FELT SEVERAL PROJECTS WERE PREMATURELY LAUNCH AND THE DATA SETS WE NEEDED TO HAVE WERE NOT THERE AND THE COMMUNITIES HAD NOT BEEN ENGAGED AS WELL AND THOUGHT IT WAS CRITICAL TO LOOK AT IT AHEAD OF THE LAUNCH AND LOOK AT AVAILABILITY ETCETERA BEFORE YOU START. AND WE COULD USE DOE CAPABILITIES IT JUST NEEDS TO BE ENGAGED BETTER THAN IT WAS. ALL THE PROJECTS NEED TO HAVE MILESTONES AND EXTERNAL OVERSIGHT MORE THAN THEY DID. THE OVERSIGHT SHOULD BE EARLY AND ONGOING TO MAKE SURE THE PROJECTS REMAIN RELEVANT SO WE MAXIMIZE THE IMPACT. HAD IT HAPPENED WE PROBABLY WOULD HAVE STOPPED IT SOONER OR RESCOPED IT SOONER. THE PROJECTS NEED TO HAVE CLOSER AND ONGOING ENGAGEMENT FROM THE NCI AND CONNECTION WITH THE EXTRAMURAL RESEARCH COMMUNITY. THAT'S WHY WHERE IT'S NEED AND IT JUST DIDN'T HAPPEN. WE MISSED A LOT OF OPPORTUNITIES THERE TO DO A BETTER JOB OF LOOK LOOKING AT THE DOE BY THE RIGHT COMMUNITIES IN THE NCI. SO CONCLUSIONS. IT'S A GOOD START AND WE THINK IT SHOULD BE CONTINUED. THE COLLABORATION IS UNIQUELY OUTED TO THE RESEARCH THAT IS OTHERWISE DIFFICULT TO DO. WE NEED TO REASSESS THE CURRENT PROJECTS AND THE LEVEL OF FUNDING TO MAKE SURE THEY'RE RIGHT SIZED FOR THE PROJECTS. [NO AUDIO] WE NEED EXPERTISE AND OVERSIGHT. A LOT OF THE WORK THAT WAS DONE WAS COMPUTATIONAL WITHOUT STRONG CANCER GUIDANCE AND THAT NEEDS TO BE FIXED. WE THINK THE CANCER MANAGEMENT NEEDS TO BE EMBEDDED IN THE APPROPRIATE EXTRAMURAL DIVISIONS AND NEED TO CREATE AN EXTRAMURAL ADVISORY GROUP FOR EACH PROJECT AND ME PROJECTS NEED TO BE ASSESSED FOR APPROPRIATENESS AND FEASIBILITY BEFORE THEY START. THAT WAS THE REPORT. IT'S A LAUDABLE IMPORTANT EFFORT AND HAS GREAT POTENTIAL BUT THERE NEEDS TO BE CHANGES MADE BEFORE WE SPEND MORE EFFORT MOVING IT FORWARD WITH THE CURRENT BUDGET. >> BEFORE WE IT UP FOR QUESTIONS I WONDER IF BOB OR OTHERS ON THE COMMITTEE WOULD LIKE TO COMMENT AT ALL? >> I WANT TO MAKE A FEW REMARKS AND JOE DID AN OUTSTANDING REPRESENTATION AND ACCURATELY DEMONSTRATE THE DIVERSE OPINION OF THE COMMITTEE. SOMETHING THAT HE SAYS I WANTED TO SAY STARTED AS AN PROJECT IN COMPUTING. ONE OF THE SEER PROJECTS WAS MORE ABOUT COMPUTATIONAL THINKING WHICH IS IMPORTANT AND WHICH DOE IS UNIQUELY QUALIFIED TO HELP OF THE TWO PROJECTS THAT WERE TALKED ABOUT THE RAS HAS A NEED FOR HIGH COMPUTING WHERE THE OTHER PROJECT WAS ABOUT COMPUTATIONAL COMPUTING WHICH AGAIN IS SOMETHING DOE CAN DO BUT MAYBE DIFFERENTLY THAN PRESENTED PREVIOUSLY TO THIS GROUP. THIS IS CONSISTENT WITH JOE AND THERE'S OTHER PEOPLE ON THE CALL MEMBERS OF BOTH COMMITTEES SO I'LL LET THEM SPEAK. CHERYL, YOU REJOINED US. DID YOU HAVE ANYTHING TO ADD? >> THANK YOU. >> I WANT TO CONGRATULATION JOE. I THINK IT IS A TOUGH REVIEW A LITTLE BIT BUT I THINK IT'S HONEST. I THINK THE WORKING GROUP OVERSEEING THE PROJECTS HAVE BEEN STATING SOME OF THESE CONCERNS FOR SOME TIME. I THINK IT WAS HELPFUL THE NCI DID THE GROUP AND SOME OVERSAW THE PROJECTS AND ADDITIONAL INDEPENDENT FOLKS WHO HADN'T LOOKED AT THE BODY OF WORK BEFORE SO THE PROCESS DAN AND OTHERS RAN WAS A GOOD ONE. I THINK IT SOLIDIFIED THE CONCERNS OF THE GROUP. JOE'S LEADERSHIP WAS TERRIFIC. I THINK THE PROJECT BENEFITTED FROM THE RAS PROJECT ITSELF AND THE FACT WE HAD GREAT SCIENCE INFRASTRUCTURE IN MOTION TO GENERATE DATA SET FOR SIGNIFICANT HIGH-PERFORMANCE COMPUTING. PROJECT 3 HAS TREMENDOUS POTENTIAL BUT WHERE WE'RE GOING NEEDS TO BE REFINED IF WE'RE GOING TRY TO MAKE SEER A REAL-TIME REGISTRY. WE HAVE TO DEFINE WHAT THE USE CASE IS AND I ALSO WANT TO EMPHASIZE ONE OTHER POINT JOE MADE. I DON'T THINK THE DOE LAB SHOULD GET TO SELF-SELECT OTHER. THERE SHOULD BE SOME SORT OF SETTING OUT OF THE SCIENTIFIC IDEA FIRST AND LETTING THE SCIENTIFIC SIDES BOTH HAVE TO COMPETE. AND THEY MUST TOGETHER IN A COMPETITIVE WAY. AND I AGAIN I WANT TO CLOSE AND THANK JOE BECAUSE HE DID AN OUTSTANDING JOB. >> THANK YOU. OTHER COMMENTS. WE CAN OPEN IT UP FOR QUESTIONS FROM THE GROUP AND EITHER ABOUT JOE'S PRESENTATION AND SUBSEQUENT COMMENTS OR ABOUT THE WRITTEN REPORT WE'LL VOTE ON IN JUST A BIT. >> ONE QUICK COMMENT. WHEN WE STARTED IT STARTED AS AN EXO SCALE PROJECT WITH THE HOPE IT COULD INFLUENCE CANCER AND IF WE HAD TO LOOK BROADLY RIGHT NOW, MACHINE LEARNING A.I. IS IMPORTANT INTEREST TO CANCER AND EXO SCALE IS IMPORTANT AND IT'S AN IMPORTANT SET OF COLLABORATIONS BUT IN TERMS OF PARTNERING WITH IMPORTANT NATIONAL INITIATIVES, A.I. HAS TURNED OUT TO BE INCREDIBLY IMPORTANT TO MACHINE LEARNING IN SCIENCE AS A WHOLE AND THIS IS NOT THE DOMINANT ARCHITECTURE USED IN A.I. THESE DAYS. >> THANK YOU. >> WHILE WE'RE WAITING I THINK AT LEAST ONE THING THAT IS STRONGLY APPARENT IS THEY WILL ENGAGE. THERE'S NO QUESTION THIS CAN BE MADE TO WORK. >> I'LL ADD ONE GRANULAR QUESTION. I LIKE THE RECOMMENDATION OF INVOLVING THE EXTRAMURAL COMMUNITY PARTICULARLY AT THE INTERFACE WITH BIOLOGY. DO YOU HAVE AN IDEA OF THE MECHANISM WITHIN THE DOE WORLD TO CARRY OUT THE INTERACTION. DO YOU THEY HAVE CAPABILITIES INTERNALLY ENOUGH BIOLOGY TO BE ABLE TO REACH OUT AND HAVE A TRUE COLLABORATION A TRUE COMMUNICATION? >> IT DEPENDS ON WHAT IS BEING ENGAGE AND IT VARIES BETWEEN THEM. I WOULD SAY IN GENERAL THE HIGH-PERFORMANCE COMPUTING GROUPS AND THIS IS MY OWN OPINION THEY'RE GOING IT TAKE LONGER THAN YOU MIGHT THINK OR LIKE IN ORDER TO GET PEOPLE TO PATIENT WHAT THE PROBLEMS ARE AND THE DOA LABORATORIES HAVE MECHANISMS THAT ALLOW THIS KIND OF ON THE JOB LEARNING TO HAPPEN. IT TAKES A WHILE BUT IT WAS DECREED WE'D GO NOW AND GO FULL AND THAT WAS PREMATURE. IF THESE THINGS HAD A MORE MEASURED RAMP UP PEOPLE COULD LEARN THEIR WAY IN THE PROJECTS AND THEY'D WANT TO INTERACT WITH THE COMMUNITIES AND THERE NEEDS TO BE A LOT OF PLANNING THAT MAY REQUIRE PROJECT PLANNING GRANTS BEFORE YOU LAUNCH THESE WHOLE SCALE THINGS. >> I THINK WHAT HAS TO COME FIRST IS THE DEFINITION OF THE SCIENTIFIC QUESTION THAT CREATES THE COMPUTATIONAL BIOLOGIC INTERFACE OF CANCER AND I LOVE THE IDEA OF SEEDING PILOT PROJECTS IN THE BEGINNING BEFORE HUGE INVESTMENTS ARE MADE BECAUSE THOSE GROUPS REALLY DO HAVE TO LEARNING TO SPEAK EACH OTHER'S LANGUAGE. PLAYING WITH THE GROUP THAT PLAYED A ROLE IN THE RAS MODELLING AFTER A YEAR OR SO THEY LOVED THAT PROJECT AND WERE IN TO IT AND LEARNED A LOT BUT IT TAKES TIMES LIKE JOE SAID. THE DEFINITION OF A SCIENCE INTERFACE AND PILOT TEAMS WITH INITIAL TUNDING TO SEE WHO TAKES -- FUNDING WHO SEE WHO TAKES OFF MAY BE BETTER. OTHER QUESTIONS OR COMMENTS FROM THE COMMITTEE? >> MAYBE THERE'S A POSITY OF PEOPLE WHO REALLY CAN SPEAK BOTH LANGUAGES. MY QUESTION BECOMES IS THAT RIGHT AND CAN YOU REALLY TAKE THE DOE PEOPLE AND TEACH THEM THE BIOLOGY THAT GETS THEM ENGAGED OR SHOULD THERE BE A WAY TO FERRET AMONG THE COMMUNITY THE RARE BILINGUAL PEOPLE. THE NUMBER OF BILINGUAL PEOPLE OUT THERE IS GROWING. THERE'S NOT A LOT OF THEM AND IT'S HARD TO BE IN THE STATE OF THE ART IN COMPUTATIONAL BIOLOGY AND HAVE A DEEP KNOWLEDGE OF WHAT'S GOING ON BIOLOGICALLY. THAT COMES OVER TIME AND WITH INCREASING ENGAGEMENT BETWEEN PEOPLE WHO INITIALLY START OFF AS BEING RATHER DOMAIN EXPERTISE ORIENTED AND GRADUALLY CROSS EDUCATE. WE SHOULD BE THINKING ABOUT THE PROJECTS AS LONGER DURATION THAN YOU MIGHT THINK. >> CAN WE GET SOMEBODY WHO STARTS ONE LANGUAGE AND LEARNS THE OTHER. >> I I THINK WE CAN CROSS LEARN. >> THE NCI HAS A BIG SYSTEMS BIOLOGY NETWORK. >> WE DO. WE CAN ASK PEOPLE TO PLAY AN INTERFACE ROLE. >> WHEN WE TALKED ABOUT THESE EMBEDDED IN THE RIGHT COMMUNITY THE EMBEDDED MODELLING FIT IN THE CANCER SYSTEMS COMMUNITY AT NCI HAS. IT'S WHERE IT TRULY SHOULD HAVE BEEN HEADQUARTERED IN THE FIRST PLACE WHERE YOU HAVE THE DOMAIN EXPERTS. THEY WOULD KNOW WHAT TO DO WITH THE COMPUTATIONAL CAPABILITIES AND THEY WEREN'T ENGAGED. THAT WIZ WAS AN OPPORTUNITY MISSED BUT IT DOESN'T MEAN IT COULDN'T WORK IF PUT IN THE RIGHT SPOT. >> IT STRIKES ME THIS IS SIMILAR WHERE TECH COMPANIES SUCH AS GOOGLE, AMAZON AND SO FORTH STARTED OFF AS YOU KNOW PROBABLY BETTER THAN I IN A COMPLETELY DIFFERENT LANGUAGE. OVER TIME THIS IS AN EVOLUTION IN DEVELOPING INDIVIDUAL INDUSTRY PRIORITIES WITH ACADEMIA. NOW YOU HAVE COMPANIES LIKE GOOGLE AND SO FORTH THAT ARE MAJOR PLAYERS IN THE DIGITAL HEALTH CARE SPACE. PERHAPS LIKE IT'S JUST WORTH BEING PROJECT ORIENTED TO DEVELOP INCENTIVE BASED PROGRAMMATIC APPROACHES WITH DOE AND DEFINE COMMON GROUND AND THEN LAUNCH THOSE SPECIFIC PROJECTS. IT'S JUST A PLUS. >> THE INCENTIVES WITHIN DOE ARE IMPORTANT AND THERE'S NOT MUCH FOR COMPUTATIONAL BIOLOGISTS OR TO TALK TO A BIOLOGIST UNLESS THEY THINK THERE'S SOME LONG TERM THERE, THERE. THE DOE LABORATORIES HAVE TO KEEP MOVING. THEY THINK THERE'S A LONG-TERM OPPORTUNITY THERE I CAN TELL YOU THEY'RE VERY EXCITED ABOUT LEARNING IN THE NEW AREAS. BUT IT HAS TO BE -- THERE HAS TO BE ENOUGH LONG-TERM OPPORTUNITY FOR THEM TO BE WILLING FOR THEM TO TAKE THE TIME TO ENGAGE. >> ARE THERE ANY OTHER QUESTIONS ABOUT EITHER DISCUSSION WE HAD OR THE REPORT? IF NOT, WE NEED TO VOTE TO ACCEPT THE REPORT OF THE NCI TASK FORCE. CATH I HAVE A MOTION TO -- CAN I HAVE A MOTION TO ACCEPT THE REPORT. >> CAN I ASK A QUESTION. CAN THOSE NOT ON THE TASK FORCE PARTICIPATE IN THE VOTE? >> CORRECT, THOSE THAT WERE NOT IN THE TASK FORCE PARTICIPATE IN THE VOTE. >> ALL IN FAVOR OF ACCEPTING THE REPORT SO INDICATE. I CAN SEE YOU ALL. >> JOE, THANK YOU FOR YOUR HARD WORK AND TO THE MEMBERS OF THE TASK FORCE IT WAS GREAT INSIGHT AND REMINDS US WHY YOU WERE SUCH A GREAT COMMITTEE CHAIR. GOOD TO SEE YOU BACK HERE. >> JOE, THANK YOU FOR DOING THIS. IT'S IMPORTANT TO GET REAL WORLD ADVICE. I DO NOT THINK THE CONCLUSION OF THE REPORT IS SURPRISING AND RESONATES WITH OUR EXPERIENCES IN TERMLY. THANK YOU FOR -- INTERNALLY. THANK YOU FOR THE SUPPORT EFFORT. >> OUR LAST PRESENTATION IS ON COVID-19 SEROTRACKER. MR. COFFEY WILL MAKE A PRESENTATION. >> HELLO. THANK YOU FOR THE OPPORTUNITY TO PRESENT. MY NAME IS NEIL FREEDMAN AND I'LL BE PRESENTING OUR WORK ON BEHALF OF THE NIH CDC SEROLOGY TEAM AND I'LL GIVE SLIDES FOR BACKGROUND AND WE'LL HAVE A DEMO OF THE PROTOTYPE DEVELOPED FOR THE. AND THEN TIME FOR QUESTIONS AND DISCUSSION. I WANTED TO START WITH TWO KEY POINTS. FIRST, THIS EFFORT LEVERAGES THE EXPERTISE GAINED FROM THE NCI CLINICAL TRIALS REPORTING PROGRAM WHEREAS THAT WAS DESIGNED TO STORE INFORMATION ABOUT NCI FUNDED CLINICAL TRIALS AND LEVERAGED AND DEVELOPED A REPOSITORY TO STORE INFORMATION ABOUT COVID-19 SERRO PREVALENCE STUDIES. THE OTHER ASPECT IS OUR RICH EXPERTISE ACROSS HEALTH AND HUMAN SERVICES. I WANTED TO POINT OUT KEY CONTRIBUTORS FROM THE CENTER FOR DISEASE CONTROL AND NNID AND NCI. THERE'S OTHER WHO CONTRIBUTE TO THIS EFFORT WHO I WASN'T ABLE TO HIGHLIGHT ON THE SLIDE BECAUSE OF SPACE. THERE'S THREE REAL AIMS. THE FIRST IS TO DEVELOP A TRANSPARENT AND PUBLICLY ACCESSIBLE REPOSITORY OF SARS COV2 STUDIES IN THE UNITED STATES AND ONCE WE OBTAINED THE STUDIES WE WANTED TO DEVELOP A HARMONIZED WAY TO CATALOG AND DISPLAY THE RESULTS FROM THEM AND THEN CREATE AN INTERACTIVE DASHBOARD TO VISUAL THEM AND COMPARE THE RESULTS AS WELL AS INFORMATION ABOUT THE STUDIES AND KEY FACTORS SUCH AS GEOGRAPHY, CALENDAR TIME AND POPULATION. THE NEED IS ON THE NUMBER OF CASES THAT WERE DIAGNOSED I FOLLOW WITH THE HOPKINS AND CDC TRACKERS ARE REPRESENTING THE TIP OF THE ICEBERG OF SARS COV2 INFECTION BECAUSE THEY TRADITIONALLY DON'T CLEAVE TO CASES AND WHERE NCI WAS A LEADER WIN OTHERS SEROPREVALENCE STUDIES CAN CLOSE THE GAP AND MITIGATE AND DESIGN EFFICACY TRIALS AND PROVE MODELS AND HOPEFULLY IN THE FUTURE DISTINGUISH NATURAL FROM VACCINE IMMUNITY AND COMBINED RESULTS THOUGH IT'S ESSENTIAL TO CHARACTERIZE THE IMPACT OF THE VIRUS IN THE UNITED STATES IT'S DIFFICULT. AND THAT'S BECAUSE THOUGH IT'S WONDERFUL THAT THERE'S BEEN A NUMBER OF TYPES OF SEROPREVALENCE STUDIES INITIATED IN THE U.S. AND WORLDWIDE THEY HAVE DESIGNS LOOKING ACROSS THE COUNTRY AND GENERAL POPULATION AND PARTICULAR POPULATIONS SUCH AS PREGNANT WOMEN, ATHLETIC ORGANIZATIONS AND HEALTH CARE WORKERS AND CROSS SECTIONAL AND LONGITUDINAL STUDIED AND SOME EXAMPLES. SHOWN IS DATA FROM THE CDC 10 SITE COMMERCIAL LABS PREVALENCE SURVEY AND FASCINATING RESULTS AND I PUT THE WEBSITE IN CASE PEOPLE WANT TO LOOK AT IT AND THEY LOOKED AT STATES AND DIFFERENT CITIES OVER TIME AND THE DATA IS FROM MARCH TO ABOUT JULY AND THEN A COUPLE WEEKS AGO THEY EXPANDED NATIONALLY. THESE ARE DATA AND PEOPLE FOR ROUTINE MEDICAL CARE AND BLOOD IS TESTED FOR CHOLESTEROL AND WORKED WITH THE NATIONAL TESTING LABS TESTING SAMPLES FOR COVID. THEY EXPANDED NATIONWIDE. THEY'RE GOING TO HAVE THIS FOR ALL 50 STATES AND THE PLAN IS TO PUBLIC IT ON THE WEBSITE EVERY TWO WEEKS. THIS IS DATA FROM HEALTHY BLOOD DONORS AND IT'S NATIONAL IN SCALE BUT THE REACH AND DESIGN IS DIFFERENT THAN THE CDC NATIONAL STUDY. THEN THERE'S STUDIES AMONG OTHER POPULATIONS SUCH AS DIALYSIS PATIENTS. THIS WAS A LARGE STUDY PUBLISHED IN THE LANCET. IN COMBINATION WITH THE LARGE STUDIES YOU HAVE CAREFULLY CONDUCTED STUDIES IN SMALLER REGIONS SUCH AS THIS ONE IN INDIANA AND THIS ONE PUBLISHED AMONG HOSPITAL WORKERS ON LONG ISLAND. THE DIFFERENT ASPECTS MATTER. WHO THE POPULATION IS AND WHEN IT WAS TESTED AND TA -- THEY'VE BEEN PUBLISHED PERFECT SERVERS AND PRESS RELEASES. SOME ARE HARD TO FIND WITHOUT SUBSTANTIAL EFFORT. IT'S DIFFICULT TO COMPARE ACROSS P FACTORS SUCH AS GEOGRAPHY AND TIME. THEY HAVE VARIOUS DESIGNS AND METHODOLOGIES AND ALSO THEY DON'T HAVE A STANDARD WAY OF SHARING THEIR PLAN AND MEC -- METHOD AND RESULTS AND ONLY SHARE AT THE TIME OF PUBLICATION WHICH COULD BE MANY MONTHS DELAYED FROM WHEN THE INFORMATION IS AVAILABLE. HAVE YOU A DUPE -- DUPLICATE EFFORT AND WE ENVISION A HELPING ANSWER QUE -- KEY QUESTIONS LIKE ARE THERE STUDIES WHERE I LIVE AND ARE THEY CHANGING OVER TIME AND ARE OTHER STUDIES GOING ON NOT YET PUBLISHED OR WHAT ABOUT TEACHERS AND HEALTH CARE WORKERS. A RESEARCHER MAY WANT TO KNOW WHAT IS THE KIND OF SEROLOGIC MOST STUDIES ARE USING AND WE SAW IT AMONG BLOOD DONORS OR DIALYSIS PATIENTS AND HOW REFLECTIVE IS IT OF THE POPULATION AND ARE THERE SYSTEMATIC SCIENCES. AND THE WORKING GROUP WHICH INCLUDED FOLKS WE HAD DISCUSSIONS WHAT KIND OF DATA FIELD DO WE WANT TO CAPTURE. THESE ARE WHAT WE CAME UP WITH, STUDY DESIGN, POPULATION, COLLECTION PERIOD AND FREQUENCY AND WE WANTED TO KNOW INFORMATION ABOUT THE TEST USED AND IF THE DATA'S BASKETBALL -- BEEN GENERATE AND POSTED AND CAN PEOPLE FIND IT AND IS IT A GREAT STUDY OR MEDIOCRE AND HOW THE RESULTS VARY BY DEMOGRAPHIC AND OTHER DETERMINATES. OUR PROGRESS TO DATE IS WE DEFINED STANDARDIZED FIELD TO ABSTAIN AND A PROTOTYPE FOR RECORDING THE STUDY DATA TO STORE AND WE HAVE SOME STUDIES RELEASING AND YOU WANT TO COMPARE EACH POINT WITH OTHER STUDIES THAT MAYBE ARE NOT NATIONAL IN SCALE BUT ARE MAYBE VERY INTENSIVE AND REFLECT THE PREVALENCE IN THAT STATE AT THAT TIME AS WE WANT TO BE ABLE TO COMPARE THEM TOGETHER IN A WAY THAT'S EASIER FOR PEOPLE TO DO. WE DEVELOPED A PROTOTYPE FOR DISPLAYING INFORMATION ABOUT THE STUDIES AND RESULTS AND AND PEOPLE INCORPORATED FEEDBACK AND CONTINUING TO DEVELOP OUR SOPs TO MAKE THEM AS ROBUST AS POSSIBLE. RELEASE THE STUDY DATA AND CATALOG THE RESULTS DASHBOARD AND DEVELOPING METHODOLOGY AND ASSESSING EACH OF THE STUDIES. CONTINUING TO GATHER DATA FROM TRADITIONAL AND LESS TRADITIONAL SOURCES FOR EXAMPLE, PRIVATE INDUSTRY OR TESTING USING SEROLOGY AND WE'RE WORKING ON DEVELOPING ONLINE USER INTERFACES AND API TO MAKE IT A MORE EFFICIENT PROCESS. THAT'S WHERE WE ARE IN GENERAL I THINK YOU'LL BE ABLE TO SEE MORE WHEN BRENT SHOWS THE DEMO. >> MY SCREEN SHOULD BE SHARING NOW AND SEE THE LANDING PAGE FOR THE DEMONSTRATION FOR THE PROTOTYPE. FIRST THING I WAS GOING SAY ABOUT THE APPLICATION WE DEVELOPED IS IT'S A PROTOTYPE AND YOU'LL SEE LAG IN THE APPLICATION AND THAT'S BECAUSE THE DATA HAS NOT BEEN FULLY CACHED BUT THE ISSUES WILL BE RESOLVED BEFORE WE PUT IT IN PRODUCTION FOR THE PUBLIC TO SEE AS A WHOLE. WE USED THE PROTOTYPE QUICKLY GATHERING REQUIREMENTS FROM DIFFERENT STAKEHOLDERS. BY KEEPING THAT STUFF OUT OF CACHE' WERE ABLE TO PUT IT TOGETHER IN A RAPID MANNER. THE FIRST THING YOU'LL SEE ACROSS THE TOP THERE'S A MAIN REPORT AND MAIN STUDY DASHBOARD. FOR THE FIRST CONCEPT WAS WE NEEDED TO SEPARATE STUDIES FROM REPORTS. ANY GIVEN STUDY MAY HAVE MANY REPORTS AND MANY REPORTS MAY COME FROM DIFFERENT STUDIES. BY REPORT WE MEAN PUBLISHED DATA OR ANY OTHERS WE ARE INTERESTED IN AND USING THE MORE GENERIC TERM REPORT. ONCE THAT HAS BEEN ESTABLISHED AT THE TOP, WHAT YOU'LL GENERALLY SEE ON THE DIFFERENT TABS IS THE GEOSPATIAL TAB OF THE UNITED STATES FRONT AND CENTER. WE SAW THE REPORTS AND STUDIES AND WHERE THEY WERE DEGRAPHICALLY LOCATED ACROSS THE -- GEOGRAPHICALLY LOCATED ACROSS THE UNITED STATES AND THE MAP IS FRONT AND CENTER FOR REPORTS AND ALSO FOR THE STUDIES. GEOSPATIAL DATA IS AN IMPORTANT ASPECT OF THIS PARTICULAR PROTOTYPE. YOU SEE THE UNITED STATES AND THE COLORS INDICATE THE NUMBER OF REPORTS IN EACH PARTICULAR CASE THE STATE HAS. THE DARKER THE COLOR THE MORE REPORTS AND IN CALIFORNIA AND NEW YORK THERE'S MORE DATA THAN FOR THE STATE OF MISSOURI. ALSO YOU'LL SEE POPULATIONS. THEY'RE NOT ALL THE POPULATIONS JUST OF INTEREST TO THE STAKEHOLDERS AND THEY'RE CALLED OUT IN A SPECIAL WAY BUT THEY'RE NOT THE ONLY POPULATIONS. YOU CAN SEE ACROSS THE BOTTOM IS THE ABILITY TO FILTER THE DATA FROM DIFFERENT LEVELS. YOU'LL SEE A LAG AND WHEN YOU LOOK AT THE STATE VIEW IT LOOKS MOST HAVE BEEN COVERED BUT WHEN YOU CLICK ON THE COUNTY IT'S FOR SPECIFIC AREAS OF THE UNITED STATES. AS WE GET ADDITIONAL DATA IN WE HOPE TO FILTER BY MORE AND MORE AREAS. ON THE LEFT SIDE WE PUT A NUMBER OF FILTERS IN PLACE. THE ALLOW THOR THE EASE OF DIFFERENT DATA ELEMENTS AND REPORTS THAT MAY BE OF INTEREST TO VARIOUS STAKEHOLDERS. YOU SEE REPORT TEST TIME AND COLLECTION PERIOD START AND AS WELL AS COLLECTION PERIOD END. WE CAN ADD DIFFERENT NEEDS BY DIFFERENT STAKEHOLDERS BUT WHAT IS INTERESTING IS FOR POPULATION THERE'S MANY DIFFERENT POPULATIONS THAT ARE ALREADY IN OUR DATA SET BUT YOU'RE ABLE TO SEE BUT NOT ACROSS THE BOTTOM OF DIFFERENT GEOGRAPHIC AREAS. I'LL CLICK ON ALL TO DE COLLECT ALL POPULATIONS AND IF THERE'S NONE UNDER STUDY THERE'S NO STUDY IN THE MIDDLE. LET'S GO TO FRONT LINE FIREFIGHTER AND PARAMEDIC WORKERS. YOU'LL SEE WHERE THERE WAS A STUDY DONE BY ON THAT PARTICULAR POPULATION IN THIS CASE YOU SEE THE MAP AUTOMATICALLY ZOOMS IN AND SHOWS THE STATE OF FLORIDA AND THERE WAS A STUDY CONDUCTED WITH THAT PARTICULAR POPULATION IN MIND OR AT LEAST ONLY IN OUR DATA SET. I'LL CLICK ALL AND IT SHOULD SHOW THE MAP OF THE ENTIRE UNITED STATES AGAIN. YOU SEE THE DATA TABLE IT'S LIKE AN EXCEL SPREAD SHEET AND SHOWS THE REPORTS IN THIS PARTICULAR CASE THAT HAVE BEEN ABSTRACTED AND IT'S AVAILABLE FOR DOWNLOAD AND YOU'LL BE ABLE TO DO IT ACROSS THE TOP WHERE YOU'LL SEE MY SESSION'S EXPIRED BECAUSE IT'S A DEMO SO I HAVE TO SIGN BACK IN. YOU CAN DOWNLOAD THE REPORT DATA AND YOU CAN SCROLL AND SEE THEM THIS IS ESSENTIALLY THE SAME DATA ON THE MAIN REPORT DASHBOARD BUT ON THE FULL RECORD DATA IT'S ALL THE REPORT DATA AND DOWN HERE IT'S JUST A FEW FIELDS OF PARTICULAR INTEREST TO SEE THEM READILY. THIS PARTICULAR DAYS I'M GOING SHOW THE YOU'LL SEE THE NUMBERS ALONG THE TOP HAVE CHANGED AND THE MAP AS A WHOLE. YOU'LL SEE ALL THE COLORS ARE THE SAME MEANING ALL HAVE THE SAME DENSITY OF REPORTS. THAT'S WHAT THE BLUE IS SHOWING ALL HAVE ONE REPORT FROM THE TIME PERIOD. I'LL THEN TAKE THE SLIDER BACK OUT AND SHOW THE ENTIRE UNITED STATES AGAIN OVER THE ENTIRE TIME PERIOD FOR THIS PARTICULAR PROTOTYPE. IT MAY BE INTERESTING TO SEE A PARTICULAR REPORT IN A PARTICULAR AREA. I'LL CLICK ON THE STATE OF LOUISIANA. IT WILL FILTER THE ASSOCIATED DATA TABLE AT THE BOTTOM TO ONLY THE REPORTS THAT CAME OUT OF THE STATE OF LOUISIANA. THIS IS THE CASE FOR THE POPULATION AND THIS IS THE FIRST REPORT ON CHILDREN AND IT WILL TAKE US TO A SPECIFIC PAGE AND YOU CAN SEE IT ALONG WHAT YOU SEE FROM THE C.D.C. DATA THE ONGOING STUDY THE DATA AS THE BASELINE NOR STUDY. YOU CAN SEE WHEN THE DATA WAS COLLECTED VERSUS WHEN THE DATA WAS COLLECTED FOR THE CDC DATA FOR THE STATE OF LOUISIANA. AT THE BOTTOM YOU CAN SEE THE DIFFERENT REVIEWS AND IT'S FOR THIS PARTICULAR REPORT AND IN ORANGE IT'S FOR THE CDC DATA YOU CAN COMPARE THEM. YOU'LL SEE THE AGE BROKEN DOWN SLIGHTLY DIFFERENTLY FROM THE REPORT WE CLICKED ON VERSUS THE CDC DATA WOULD WE HAVE DIFFERENT BRACKETS. YOU SEE SEX AND WE CAN COMPARE THE ORANGE AND YELLOW DATA SETS TO COMPARE BASELINES TO COMPARE A REPORT TO. THIS IS NOT THE ENTIRE STATE OF LOUISIANA AND YOU CAN CLICK ON COUNTY. THE LAST THING I'LL SHOW AS I MENTIONED BEFORE THE DATA FROM THE CDC COMING IN AT DIFFERENT TIMES AND WE EXPECT THAT TO COME TO DIFFERENT ROUNDS YOU CAN COMPARE THE DATA SET TO ANY GIVEN ROUND OR TURN OFF THE DATA OVERLAY IF YOU'D LIKE WHICH WOULD TURN OFF ALL THE ORANGE DATA IF I CLICKED ON 2 YOU'LL SEE THE BARS LINE UP DIFFERENTLY. I'VE ALSO SHOWN MOST EVERYTHING THAT IS OF PARTICULAR INTEREST HERE BUT WHAT I WANTED TO ILLUSTRATE IS THAT ONCE YOU UNDERSTAND HOW REPORTS WORK STUDIES IS NOT GOING WORK TERRIBLY DIFFERENTLY AND YOU'LL SEE THE MAIN STUDY DASHBOARD HAS THE GEOSPATIAL MAP IN THE CENTER AND INTERESTING INFORMATION ALONG THE TOP THAT IS OF PARTICULAR INTEREST TO GIVE YOU SUMMARY DET AND FILTERS ON THE -- DATA AND FILTERS AND POPULATIONS ALONG THE BOTTOM AS THE REPORTS PAGE DID HOWEVER, IF YOU LOOK CLOSELY YOU CAN SEE THE FILTERS ARE SLIGHTLY DIFFERENT AS WELL AS THERE ARE OTHER SLIDE DIFFERENCES ON THE PAGE. LIKE THE REPORTS THERE'S A FULL STUDY WHERE THE STUDIES CAN BE DOWNLOADED AS WELL. THEY CAN ALSO BE STUDIED. TO SHOW THE DIFFERENCE BETWEEN THE TWO FIRST YOU SEE THE MAP IS PHYSICALLY LOOKING DIFFERENT BECAUSE THERE'S DIFFERENT STUDIES. WE HAVE THEM IN DIFFERENT AREAS THAN WE HAVE REPORTS FROM AND WE WILL CLICK ON THE STATE OF CALIFORNIA THERE'S FILTERS AND THE DATA TABLE AT THE BOTTOM AND ALL THE STUDIES FROM THE STATE OF CALIFORNIA WE'LL LOOK AT THE ONE FROM LOS ANGELES AND IT WILL TAKE YOU TO A PAGE SPECIFICALLY SET ASIDE FOR THAT PARTICULAR STUDY. IT LOOKS LIKE THE ENTIRE STATE OF CALIFORNIA IS IN VIEW BUT THAT'S NOT THE CASE AND IT WILL ZOOM TO THE PARTICULAR COUNTY UNDER STUDY AND AS I ZOOM OUT YOU'LL SEE THAT IS ONLY A SMALL PORTION OF THE STATE OF CALIFORNIA. THIS WILL TAKE YOU TO A REPORT ON THAT PARTICULAR DATA SET. WE DO HAVE THOSE LINKED IN THE SYSTEM. YOU SEE THE TEST SPECIFICITY AND SENSITIVITY AS WELL AS DETAILS SUCH AS THE P.I. AND LEAD ORGANIZATION CONDUCTING THE STUDY. FINALLY, DITCH FROM THE STUDY OR REPORTS IS THE SCATTER PLOT. IT'S WHERE WE'RE GOING TO SHOW ZERO PREVALENCE CHANGE OVER TIME. IN THIS PARTICULAR DATA SET NOT ALL DATA YOU'RE GOING TO BE VIEWING IS REAL BECAUSE WE DO NOT HAVE A FULL DATA SET. IT'S NOT THE CASE WITH REPORTS OR STUDIES. THAT'S WHAT WOULD HAVE BEEN EXTRACTED AND SHOULD BE GOOD DATA. WE CAN UNCHECK ALL AND IF WE'RE NOT LOOKING AT COLLECTION SITES YOU SEE NO DOTS ON THE SCREEN. WE CAN CLICK ON THE STATE OF NEW YORK AN AGAIN THE DATA IS NOT REAL. THE DATA IS FICTIONAL FOR PURPOSES OF DEMONSTRATION. THE COLORS ARE SHOWING HERE AND PREVALENCE NOR PARTICULAR POPULATIONS AND CAN SEE THE TIME ACCESS AND IT HAS CHANGED OVER TIME. AND THAT IS HOPE TO SHOW AS WE GET ADDITIONAL DATA SITS IN AND WORKING ON GETTING THEM FROM CDC AND OTHERS AND HOW WE HOPE TO SHOW ZERO PREVALENCE CAN CHANGE OVER TIME ON THIS PARTICULAR TRACKER. THE PLAN AS NEIL POINT THE OUT IS TO RELEASE THIS IN CYCLES OR PHASES. THE FIRST PHASE IS DUE OUT IN A FEW WEEKS AND THAT'S THE INITIAL LANDING PAGE AND BUILDING THE DASHBOARD IN A PRODUCTION MANNER TO GET THE DATA TO THE PUBLIC. HAVING THAT THAT I'LL TURN IT BACK IT NEIL FOR QUESTIONS. >> YOU FEEL YOU'RE A COUPLE WEEKS FROM AN INITIAL LAUNCH? >> THAT'S OUR COUNT -- CURRENT PLAN TO RELEASE IN PHASES AND HOPE TO HAVE A BASIC LANDING PAGE DRIVING THE ACTIVITIES WE'RE DOING WITH AN INITIAL SET OF DATA FOR THE INITIAL RELEASE AND OVER TIME ADDING IN MORE AND MORE MAPS AND GRAPHICS YOU SEE AS WE GET MORE DATA SETS IN. >> ONE WOULD THINK THE DATA'S GOING GROUP SHARPLY. >> WE EXPECT THAT AS WELL. WE'RE HOPING TO SPREAD THE WORD AND AS WE SHOW MORE AND PEOPLE WILL SHARE THE INFORMATION THEY'RE DOING THAT WILL HELP US IDENTIFY THE STUDIES GOING ON. I AGREE THE NUMBER OF STUDIES ARE EXPECTED TO INCREASE DRAMATICALLY. >> IS IT FAIR TO ASSUME THE CLINICAL TRIALS BEING RUN ARE DOING SEROLOGY ALONG WITH PCR? SOME ARE AND SOME AREN'T. WE'RE WORKING WITH ESTABLISHED NETWORKS AND SERONET STUDIES REPUBLIC FUNDED AND UNDERWAY AND WE'RE PLANNING TO INTERACT WITH THEM. WE'RE INTERACTING WITH THOSE FUNDED BEEN NIAID FUNDED AND CDC AND STATE AND LOCAL HEALTH DEPARTMENTS. >> ANYTHING ELSE? THANKS FOR THE PRESENTATION AND WE LOOK FORWARD TO UPDATES IN THE FUTURE. WE'RE NEAR THE END OUR TIME AND I WONDERED IF NED OR KAREN HAVE ANYTHING ELSE THEY'D LIKE TO ADD. >> THANK YOU EVERYONE. GOOD TO SEE EVERYONE VIRTUALLY. ANOTHER PRODUCTIVE FNLAC. WE'LL TAKE THE ADVICE OF THIS BOARD SERIOUSLY. THANK YOU ALL AND NO FURTHER COMMENTS. KAREN? >> I TOO WOULD LIKE TO THANK EVERYBODY. IT WAS GREAT TO SEE EVERYONE VIRTUALLY. PENCIL IN FEBRUARY 23 AS OUR NEXT MEETING. IT WILL BE VIRTUAL. HOPEFULLY BY JUNE WE'LL BE ABLE TO ONCE AGAIN SEE EACH OTHER IN PERSON BUT WE'LL SEE HOW THAT GOES. THANK YOU ALL VERY MUCH. STAY SAFE. >> THANKS VERY MUCH. THANK TO EVERYBODY. IF YOU HAVE ANY THOUGHTS SEND THEM TO ME OR KAREN AND THE MEETING IS ADJOURNED.