>> WELCOME, EVERYBODY AND IT'S GREAT TO SEE YOU AND IT WILL BE A VERY PRODUCTIVE MEETING. I WANTED TO START BY ANNOUNCING OFFICIALLY, EVEN THOUGH I THINK IT'S CLEAR TO EVERYONE THAT PAT LOEHRER HAS AGREED TO BE THE NEW CHAIR OF CTAC, WE CAN SEE YOU SOMEWHAT DARKLY, PAT, BUT YOU'RE THERE. CHANCE TO EXPRESS OUR REAL GRATITUDE TO NANCY DAVIDSON ON HER PART OF CTAC, AND AS SOME OF YOU MAY KNOW, SHE'S NOT ACTUALLY LEAVING CTAC, SHE'S ACTUALLY JOINING THE BOARD OF COUNSELORS AND WILL JOIN US AT THE NEXT MEETING SO WE'RE APPRECIATIVE FOR PAT'S LEADERSHIP AND NANCY'S CONTINUING SERVICE SO PATRICK NONAPOPTOTIC YOU THAT YOU'RE, OFFICIALLY THE CHAIR, WHY DON'T YOU GET STARTED. THANK YOU AND IT'S A GREAT HONOR TO FOLLOW NANCY IN THIS POSITION HERE, I WANT TO WELCOME ALL THE MEMBERS HERE THIS IS THE 38th CTAC MEETING, I NEED TO READ AN OPENING STATEMENT AND IF YOU BEAR WITH ME, AS COMMITTEE MEMBERS I WANT TO REMIND YOU THAT YOU MUST ABSTAIN YOURSELF DURING SPECIFIC DISCUSSIONS WHENEVER YOUR DISCUSSIONS OR DELIBERATIONS ON A PARTICULAR PRODUCT, PROGRAM OR SPECIFIC MANNER WOULD CONSITUTE A CONFLICT OF INTEREST OR CREATE THE APPEARANCE OF 1. IT'S INCUMBENT FOR YOU TO ADVISE THE SECRETARY AND ABSTAIN IN DISCUSSION OR ACTION REGARDING THAT MATTER. IN LIGHT OF THE CURRENT POLICIES GOVERNING CONFLICT OF INTEREST BASED ON FINANCIAL HOLDINGS OF GOVERNMENT EMPLOYEES WHICH INCLUDE ALL THE MEMBER OF THIS COMMITTEE WE MUST DEPEND ON YOU TO VOLUNTARILY ABSTAIN YOURSELF DURING ANY AND ALL DISCUSSIONS OF MATTERS THAT COULD CONCEIVABLY IMPACT THE STATUS OF THOSE HOLDINGS. WE TRUST YOUR JUDGMENT IN THESE INSTANCES. MY BAH A QUORUM OF BOARD MEMBERS IS REQUIRED FOR EACH INSTANCE FOR WHICH IT OCCURS IN AN OPEN SESSION, DURING THIS MEETING A MINIMUM OF 11-POINT MEMBERS MUST BE PRESENT TO VOICE THEIR VOTES. NEW MEMBERS WHO ARE NOT CURRENT MEMBERS OF OTHER NCI ADVISE REBOARDS ARE NOT VOTING UNTIL THEY'VE BEEN CLEARED BY THE NCI ETHICS OFFICE AND THE OFFICE OF HUMAN RESOURCES. SO MEMBERS OF THE PUBLIC WHO MAY WISH TO EXPRESS VIEWS REGARDING ANY ITEMS DISCUSSED DURING THIS MEETING MAY DO SO IN WRITING TO DR. SHIELDA PRINDEVILLE, AND ANY OTHER COMMENTS BY MEMBERS OF THE PUBLIC AND COMMITTEE WILL RECEIVE CAREFUL CONSIDERATION. I WANT TO LET EVERYBODY KNOW THAT ALTHOUGH THIS IS A WEBINAR, IT WILL BE BROADCAST AND AVAILABLE ON THE NIH VIDEOCAST WEBSITE, THIS WILL BE ARCHIVED FOR VIEWING LATER AS WELL. WHEN YOU LOOK AT YOUR,A GENDA, YOU WILL SEE THE THAT THE NEXT MEETING WILL BE JULY 17th AND THAT WILL BE AT THE NCI. FIRST, AGAIN, I WANT TO RECEIVE A MOTION AND SECOND FOR MEETING SUMMARY NOTES FROM THE NOVEMBER 7, 2018 MEETING. YOU WILL HAVE TO BE OFF MUTE IN ORDER TO DO THAT. >> SECOND. >> ALL RIGHT. IF THERE ARE ANY DESCENSIONS LET ME KNOW BECAUSE IT'S HARD TO TAKE A VOICE VOTE. NO DESCENSIONS THEN WE WILL APPROVE THESE MINUTES. I ALSO WANT TO PARENTHETICALLY STATE THAT THESE MINUTES ARE OUTSTANDING, YOU DO IA TERRIFIC JO BE--JOB IN CAPTURING IT. NEXT I WOULD LIKE TO GRIEWS DR. NED SHARPLESS WHO WILL MAKE COMMENTS REGARDING THE NCI AND UPDATES HE HAS LIMITED TIME TO TALK, ABOUT 10 MINUTES AND THERE WILL BE NO TIME FOR QUESTIONS. DR. SHARPLESS. >> THANK YOU, PAT, FOR THE DRUKS, AS MENTIONED HAVE LIMITED TIME SO I'LL BE QUICK. SO LET'S SEE, FIRST I WOULD LIKE TO THANK NANCY DAVIDSON OF HER LEADERSHIP FOR THIS COMMITTEE FOR A WHILE, SHE HAS DONE SO FOR MANY TIMES AND WILL CONTINUE TO DO SO FOR THE BSC, AND PAT, THANK YOU AND WELCOME, SO THE WO, THAT ALL OF YOU DO ON THIS COMMITTEE IS VALUED AND APPRECIATED. I KNOW YOU ALL HAVE OTHER THINGS THAT KEEP YOU BUSY IN LIFE. WE HAVE A FEW VISITING GUESTS ITED THAT WILL TALK ABOUT THE PANCREATIC CANCER AND SMALL CELL PRESENTATIONS LATER AND WELCOME VISITING GUESTS TO CTAC TODAY. SO, I WOULD LIKE TO HIT A FEW HIGHLIGHTS OF THINGS THAT ARE OF FREIGHT INTEREST TO THE NCI AT PRESENT. ONE TOPIC THAT I'VE SPENT A LOT OF TIME TALKING ABOUT RECENTLY IS THE RPG POOL, THE RESEARCH PROJECT GRANT POOL THAT FUNDS RO1S AND PO1S AND THE TYPES OF GRANTS THAT ARE INVESTIGATOR-INITIATED AND INCLUDING A SIGNIFICANT PORTFOLIO OF CLINICAL TRIALS. THE GOOD NEWS ABOUT THE RPG POOL IS BECAUSE OF THE SUPPORT OF CONGRESS IN 2018, WE WERE ABLE TO HAVE 1 OF THE LARGEST INCREASES TO THE RPG POOL IN QUITE A WHILE SINCE 2003 WHICH IS THE PERIOD OF NIH DOUBLING AND I EXPECT AND HOPE WE WILL BE ABLE TO HAVE A SIMILAR INCREASE TO THE TOTAL FUNDING TO THE RPG POOL IN 2019, SO WE'RE TRYING TO PUT FUNDS INTO THE RPG POOL TO SUPPORT THE GREAT SCIENCE THAT IS GETTING SUBMITTED TO NCI, THE BAD NEWS, SORT OF BAD NEWS ABOUT THE RGP POOL IS THAT DESPITE OUR EFFORTS TO PRIORITIZE EFFORTS FOR IT, PAY LINES AT THE NCI ARE LOW, SO ON THE ORD ARE OF 8% FOR AN ESTABLISHED INVESTIGATOR WRITING AN RO1 WHICH IS DEMORALIZING NUMBER TO THE CEREBELLUMS TERNAL COMMUNITY AND I'M WELL AWARE OF THE HARDSHIP THAT NUMBER CAUSES FOR YOUNG INVESTIGATORS BUT AS WELL AS ESTABLISHED INVESTIGATORS, THE REASON FOR THAT IS I'VE OUTLINEUPED OTHER CONVERSATIONS IS THIS--ALTHOUGH WE'RE FUNDING MORE INVESTIGATORS THAN EVER AND PUTTING MORE MONEY THAN EVER, THERE'S BEEN A MASSIVE INFLUX OF APPLICATIONS, TO THE TUNE OF 60% INCREASE FOR RO1S SINCE 2009, A PERIOD WHEN TOTAL APPLICATIONS TO THE NIH ARE ONLY UP BY 10%. SO THIS IS A UNIQUE PHENOMENON GOING ON IN CANCER RESEARCH AND IT'S AN INTERESTING QUESTION THAT I HAVE THOUGHTS ON AS TO WHY SO MANY PEOPLE ARE MIGRATING TO THE FIELD OF CANCER RESEARCH, I CAN TELL YOU A COMMON THEME IS SEEN IN INDUSTRY IF YOU LOOK AT PORT NOELYS BY THERAPEUTIC CLASS AND AREA, IN INDUSTRY THERE'S FOCUS ON ONCOLOGY AS WELL BUT IT IS HAPPENING AND FROM THE NCI'S POINT OF VIEW, IN SOME WAYS IT'S I GOOD PROBLEM TO HAVE, WE ARE IMETTING GREAT NEW IDEAS AND GREAT SCIENCE BUT WE ARE ALSO, YOU KNOW SEEING INCREASED COMPETITION FOR FUNDING FROM THE NCI THAT IS MAKING IT CHALLENGING FOR CERTAIN INVESTIGATORS. BECAUSE OF THAT, PRESSURE FOR AND LOW PAY LINES AT THE IN, CI IN 2018 MADE A REAL EFFORT TO PRIORITIZE THE PLIGHT OF THE EARLY STAGE INVESTIGATOR, THE ESI, SO ESIs ARE--DEFINED WITHIN 10 YEARS OF THEIR TRAINING AND AND WE WERE ASKED BY THE 21st CENTURY CURES LEGISLATION TO DO MORE FREE ESIs AND THE MANDATE TOOK THAT SERIOUSLY AND WE WERE ABLE TO INCREASE THE TOTAL NUMBER OF ESI, RO1 EQUIVALENT AWARDS IN BY MORE THAN 25% IN 2018 AND WE HOPE TO HAVE A CONTINUE AND EXPECT TO HAVE A CONTINUED STRONG FUNDING OF ESIs IN 2019. SO TO THE EXTENT POSSIBLE THAT WE CAN MINIMIZE THE EFFECT OF THESE LOW PAY LINES AND ESIs AT LEAST, WE'RE TRYING TO DO THAT, AND LASTLY AND I MENTIONED, THE AWARDS UP BECAUSE OF THE NEW FUNDING BUT AGAIN IN THE SETTING OF A VERY STIFF COMPETITION FOR NEW FUNDING FROM THE NCI. A FEW OTHER REALITIES TO TALK ABOUT IN 2019, WE I THINK WERE WELL SUPPORTED BY CONGRESS, SEEING ABOUT AN ALMOST 180 MILLION-DOLLAR INCREASE TO OUR BUDGET IN 2019, ALSO A BUDGET THAT WAS PASSED AT THE BEGINNING OF THE FISCAL YEAR, AND THE ENTIRE YEAR BUT AGAINST THOSE PROBLEMS I'VE ALREADY MENTIONED THE INCREASE IN FUND FOR THE POOL AND WE HAVE RENT, TAPS, TRANSFERS WITHIN THE NIH AND THERE'S A STIPEND INCREASE TO SOME OF OUR TRAINING GRANTS AND INCREASE IN,A WARD SIZES AT THE IN, CI THAT WE HAVE LOOKED AT CAREFULLY BUT IT IS TO SOME EXTENT THE TREND REFLECTING THE CANCER RESEARCH, I WOULD SAY AND NONCOMPETING SO OUT-YEAR COSTS SO IF THE AWARDS GET BIGGER IN THE COST, WE SEE THOSE IN THE OUT-YEARS FOR THE AWARDS TO COME, SO IN THE NEWER AWARDS, THE NUMBER DOESN'T GO UP THAT MUCH BUT WE'RE SEEING COSTS FOR OUT-YEAR GRANTS. SO THOSE REALITIES, EVEN DESPITE A GOOD FUNDING YEAR, I WOULD SAY CAUSE THE NCI TO DO SOME FAIRLY DIFFICULT THINGS OF LOOKING AT--SPENDING IN NONRPG AREAS OF THE NCI AND IN SOME INSTANCES CUTTING THE DIVISION BUDGETS BOO I A MODEST AMOUNT AND USING THOSE TO PRIORITIZE OTHER THINGS, FOR THE MOST PART THOSE, I THINK THE NCI'S BEEN BEHIND THOSE DECISIONS AND HAS YOU KNOW UNDERSTANDS THE SORT OF SPECIAL NATURE OF THE TIME THAT WE REALLY HAVE TO TRY AND NOT DEPRIVE THIS INNOVATION COMING TO THE NCI AND WERE THE ISED THAT DECISION ALTHOUGH CUTS TO THE FEDERAL PROGRAM ARE CHALLENGING AND I APPRECIATE THE IN, CI FOR WORKING WITH ME TO HELP THAT HAPPEN. IT'S THAT TIME OF YEAR WHEN THE NCI DIRECTOR PUTS ON A SUIT AND GOES DOWN AND SITS IN FRONT OF A GROUP OF GRIM LOOKING CONGRESS MEN AND I EXPECT TO BE TESTIFYING BOTH IN FRONT OF THE HOUSE AND SENATE APPROPRIATION COMMITTEES IN EARLY APRIL, I THINK, APRIL 2 AND 11 ARE COMING UP TO DISCUSS THE PRESENCE BUDGET THAT SHOULD BE RELEASED SOONOT 11th WE BELIEVE AND A DETAILED BUDGET ON THE 18th. AND YOU KNOW THAT IS A REAL PRIVILEGE OF GOVERNMENT TO GO AND EXPLAIN TO THE LEGISLATORS WHY THE GREAT WORK THE NCI DOES, IS DOING AND I WOULD FRANKLY SAY AN AREA THAT I'VE ENJOYED DOING BECAUSE THE NCI IS REALLY WELL LIKED IN CAPITOL HILL. EVERYONE LIKES CANCER RESEARCH, THEREYA A STRONG FEELING THAT WE'RE MAKING PROGRESS TO THIS DISEASE AND THERE'S IS A GOOD USE OF FEDERAL MONIES AND SO, YOU KNOW MORE TO COME. I WOULD LIKE TO SAY A BRIEFLY A WORD ABOUT FREDERICK NATIONAL LAB, AS IF OF YOU ARE AWARE, THIS AN IMPORTANT CAPABILITY FOR THE NATIONAL CANCER INSTITUTE AND IT HOUSES A REAL MYRIAD OF FUNCTIONS TO THE EPITHELIAL RAMAURI OSHEROFFAL, EXTRA MURAL PROGRAMS AND PARTICULARLY MANY IMPORTANT AREAS OF SUPPORT FOR CLINICAL TRIALS, SO FOR EXAMPLE, A LOT OF CANCER GENOMEAT LAS PINTAS WAS THROUGH THE FREDERICK NATIONAL LAB, A LOT OF MOLECULAR TESTING AND THE MATCH TRIAL WAS ADMINISTERED THROUGH FREDERICK NATIONAL LAB, AND PART OF OUR SPIN ON BIG DATA ARCHITECT THAT YOU ARE SUPPORTS CLINICAL TRIALS AND OTHER DATA EFFORTS ARE THROUGH FED RICK NATIONAL LAB SO IT'S A CRITICAL ENDEAVOR FOR THE NCI, IT IS A COMPLICATED FEDERAL ENTITY AND HAS SOME CONTRACTING CHALLENGES THAT WE ARE ADDRESSING AND MAKING WORK. IMPORTANTLY OUR PLANS AS BEEN STATED PUBLICLY ARE TO RECOMPETE THE FREDERICK WARD SOMETIME IN THE NEXT FEW YEARS SO WE'RE GEARING UP FURIOUSLY FOR THAT PROCESS WHICH INCLUDES PROVIDING A STATEMENT OF WORK AND STRATEGICALLY THINKING ABOUT WHAT THE FREDERICK LAB SHOULD BE. IT WAS DR. VARMIS SAID THAT ESSENTIA WILY THE MISSION BUT THEREFORE IT HAS TO BE AWESOME AND GREAT AND TRY TO PUT IT ON A TRAJECTORY TO AWESOME AND GREATNESS AND I THINK WE MADE A LOT OF POSITIVE DEVELOPMENTS THERE SINCE BRINGS IN THE DECISION AND BRINGING IN THE GREAT SCIENCE AND THE INITIATIVE AND THE MATCH TRIAL AND CRYOEM AND OTHER TOPICS THERE AND I'M EAGER TO CONTINUE BUILDING ON THAT MOMENTUM. I'D LIKE TO THANK MEMBERS OF THIS--OF CTAC FOR THEIR LEADERSHIP AND EVERYBODY'S ON THESE IMPORTANT WORKING GROUPS SO AS MANY OF YOU RECALL 1 OF THE RECOMMENDATIONS FOR THE EVALUATION OF THE SPORE PROGRAM WAS FOR THE NCI TO CONVENE, TRANSLATIONAL WORKING GROUPS TO HELP SORT OF IDENTIFY FOR 1 OF THE BETTER TERM, WHAT'S HOT, A REAL OPPORTUNITY IN SPECIFIC RESEARCH AREAS IN CANCER. WE THOUGHT A BIT ABOUT THIS AND DISCUSSED WITH SOME OF YOU HOW THESE WORKING GROUPS SHOULD WORK AND HIT UPON THIS IDEA OF MAKING--NOT SOLELY DISEASE FOCUSED BUT SOMETIMES MORE THERAPEUTIC AREA FOCUSED AND SO WE DECIDED WE WOULD TEST OUT THIS IDEA WITH BOTH GLIOMA AND ONCOLOGY AND THE GLIOMA WORK HAS MEETINGS AND WELL ALONG ITS WAY AND ABLY LED BY KHIHIGH DANG WALI KERN AND THEN RADONC AND JUST GETTING STARTED LEAD BY ADAM DICKER AND SYLVIA FORMENTI, THANK YOU FOR YOUR SERVICE ON THIS AND THE AREA THAT IS VERY EXCITING TO HELP THE NCI IDENTIFY REAL OPPORTUNITIES FOR THERAPY AND PUTTIC RESEARCH, SO I WON'T TAKE QUESTIONS RIGHT NOW BUT I WILL BE HERE FOR THE ENTIRE MEETING AND HAPPY TO TALK ABOUT SPECIFIC AREAS AS NEEDED RELATED TO OUR DISCUSSIONS SO THANK YOU AGAIN FOR BEING HERE TODAY. >> THANK YOU FORM. INCREDIBLE THAT YOU STOPPED RIGHT ON TIME, TERRIFIC JOB. OUR AGENDA ISN'T THAT DEEP TODAY. WE HAVE A COUPLE PRESENTATIONS. THE FIRST PART IS A FOLLOW UP OF OUR LAST MEETING AND DR. JIM ABBRUWRRKS ZESE, IS THE CHAIR OF THE PANCREATIC DUCTAL ADEN O CARCINOMA RESEARCH WORKING GROUP. HE IS HERE ON THE WEBINAR, HE WILL NOT GIVE A FORMAL PRESENTATION BECAUSE HE DID THIS LAST MEETING BUT THE REAL REASON FOR THIS SESSION IS TO ALLOW THE MEMBERS HERE THE OPPORTUNITY TO DISCUSS THIS PROGRESS IN THE PANCREATIC DUCTAL ADEN O CARCINOMA RESEARCH WORKING GROUP. AND THESE ARE BY THE PTAC SCIENTIFIC RESEARCH AND THESE FINDINGS WILL ASSIST THE NCI IN ASSISTING THE SCIENTIFIC FRAMEWORK WHICH IS DUE TO BE SUBMITTED TO CONGRESS THIS MONTH IN RESPONSE TO THE RECALCINANT CANCER RESEARCH ACT OF 2012. THE GRUP MET IN OCTOBER OF 2018. DR. ABBRUZZESE, PRESENTED THOSE FINDINGS FROM LAST YEAR AND TODAY WE WANT TO DISCUSS THE FINAL REPORT AND EVENTUALLY TAKE A MOTION TO ACCEPT THE REPORT AND FOLLOW DISCUSSION. JIM WILL JOIN THE MEETING HERE TO ANSWER QUESTIONS. CTAC MEMBERS WERE ALSO MEMBERS OF THE WORKING GROUP AND WE WOULD APPRECIATE COMMENTS FROM THEM. SO TO START OFF I THOUGHT I WOULD JUST ASK JIM IF HE WANTED TO--ACTUALLY THERE'S A SUMMARY SLIDE OF WHAT'S BEEN GOING ON BUT WHAT I TALKED ABOUT BUT WHAT WE WOULD LIKE TO DO IS TODAY BASICALLY DISCUSS THIS FINAL WRITTEN REPORT OF THE WORKING GROUP. WE WILL TAKE THE MOTION TO ACCEPT IT, AGAIN AS I MENTIONED LATER ON THIS MONTH THE IN, CI WILL SUBMIT THE FRAMEWORK TO CONGRESS AND THEN THIS WILL BE FINALIZED THEN. SO JIM WOULD YOU LIKE TO PROVIDE A BIT OF OVERVIEW AND MAYBE SOME OF THE HIGHLIGHTS REAL BROO EVALUATION PROCESSLY AND THEN IF THE REST OF THE COMMITTEE MEMBERS WHO ARE ON THE GROUP WANT TO COMMENT AND THEN WE'LL HAVE IT OPEN FOR DISCUSSION? >> SURE. THANK YOU VERY MUCH. ARE YOU ABLE TO HEAR ME OKAY? >> YES, PERFECT. >> GREAT. SO I GAVE I THINK A DETAILED, MAYBE TOO DETAILED PRESENTATION A COUPLE MONTHS AGO ABOUT THE PROGRESS OF THE WORKING GROUP. I WOULD SAY THAT OUR GENERAL SENSE IN TERMS OF REVIEWING THE PROGRESS THAT HAS BEEN MADE OVER THE PAST 5 YEARS WAS VERY POSITIVE. I HAPPENING THERE HAS BEEN SIGNIFICANT PROGRESS IN MANY AREAS INCLUDING LAUNCHING--LONGITUDINAL SCREENING EFFORTS, FOR BIOMARKER DEVELOPMENT AND IDENTIFICATION OF PATIENTS WITH EARLY SIGNS AND SYMPTOMS PANCREATIC CANCER FOR EARLIER DIAGNOSIS. THERE HAS BEEN EFFORT--EFFORT, TREMENDOUS EFFORT AS DR. SHARPLESS MENTIONED AROUND THE RAS INITIATIVE AT FREDERICK AND WE'RE SEEING MAYBE RAS SPECIFIC COMPOUNDS THAT ARE EMANATING FROM THAT WITH INTERESTING BUT VERY PRELIMINARY SENSE THAT THERE MAY BE ACTIVITY IN THIS VERY SPECIFIC RAS MUTATED GENES, PARTICULARLY G12 C. AND YOU KNOW WE FELT THAT IN GENERAL THE PROGRESS HAS BEEN ON TRACK BUT IT HAS BEEN 5 YEARS AND WITH SUCH A CHALLENGING NEOPLASM, I THINK WE ALL RECOGNIZE THAT ADDITIONAL WORK NEEDS TO GO ON AND SERIOUS THOUGHTS NEED TO PUT INTO THE DECISIONS ABOUT CONTINUING TO FUND SOME OF THE--ESPECIALLY SOME OF THE LONGITUDINAL STUDIES THAT WILL TAKE YEARS IF NOT DECADES TO REALLY SEE THE FRUITS OF THOSE ACTIVITIES. WE FOCUSED ON BASICALLY 4 AREAS THAT ARE OUTLINES IN THE REPORT. PANCREATIC CANCER BIOLOGY WHICH ENCOMPASS GENOMICS METABOLOMICS AND TUMOR BIOLOGY. WE TALKED EXTENSIVELY ABOUT ANIMAL AND HUMAN ISSUE MODELS. RECOGNIZING THAT PROGRESS HAS BEEN MADE IN THIS AREA WITH THE DEVELOPMENT OF ORGANOIDS AND NEWER ANIMAL MODELS, GENETICALLY ENGINEERED MOUSE MODELS THAT I THINK ARE PROVIDING INSIGHTS INTO PANCREATIC CARCINOGEN SIS AND OPPORTUNITIES FOR THERAPEUTICS. WE CONTINUED DISCUSSIONS AROUND RISK PREVENTION AND SCREENING AND EARLIER DIAGNOSIS, AGAIN NOTING THAT SOME OF THE EFFORTS STARTED REALLY CONTINUE TO BE SUPPORTED AND THEN FINALLY, THE LAST PORTION WAS AROUND TREATMENT AND SOME OF THE NEWER OPPORTUNITIES, THEY'RE NOT JUST TARGETING R,A S BUT DISCUSSION ACTUALLY ON THE ISSUES THAT ARE ASSOCIATED--SO STRONGLY ASSOCIATE WIDE PANCREATIC CANCER SUCH AS PKEPSIA AND UNDERSTANDING BETTER THE TUMOR MICROENVIRONMENT ESPECIALLY AS WE TRY TO TAKE PANCREATIC CANCER AND A COLD NEOPLASM TO 1 THAT MIGHT BE TRACTABLE WITH IMMUNOTHERAPY. SO, I'LL STOP THERE, I'M REALLY HAPPY TO BE HERE AND ALSO TO ANSWER ANY QUESTIONS THAT I CAN ABOUT THE REPORT. MANY PEOPLE CONTRIBUTE TO THIS, [INDISCERNIBLE] REALLY DID A TREMENDOUS JOB LOOKING AT THE FINAL PRODUCT AND MAKING NUMEROUS COMMENTS ALONG THE WAY. >> JIM, I WANT TO JUST COMPLEMENT, THIS WAS REALLY A TERRIFIC REPORT. IT'S SO INDEPTH AND IT REALLY DOES SET THE FRAMEWORK FOR RESEARCH IN THIS VERY IMPORTANT DISEASE. LYNN, DAVID OR FLORRIA --GLORIA, DO YOU HAVE COMMENTS OR ANYTHING YOU WOULD LIKE TO ADD? >> THIS IS LYNN. , GO AHEAD DAVID. >> YOU GO FIRST, YOU DID MORE WORK ON THIS THAN I DID, PLEASE. [LAUGHTER] >> YEAH, I JUST WANT TO ECHO WHAT JIM SAID IS THAT I THINK THE REPORT VERY NICELY SHOWS THE EFFORT THAT'S PUT INTO IT, THE RESPONSIVENESS OF THE NCI TO THE RECALCITRANT CANCER RESEARCH ACT, THE--ALL THE PROGRESS THAT AN BEEN MADE ON THOSE 4 PRIORITIES THAT WERE LAID OUT. IT ALSO DOES A REALLY GOOD JOB OF LOOKING TO THE FUTURE. WHAT HASN'T BEEN DONE, WHAT ARE THOSE OPPORTUNITIES AND WHERE IS THERE STILL MORE WORK THAT NEEDS TO BE DONE IN THIS AREA SO I THINK IT'S--IT NOT ONLY IS A VERY GOOD--WE SHOULD BE VERY PROUD OF SENDING THIS TO CONGRESS TO SHOW WHAT'S BEEN DONE AS A RESULT OF THIS, BUT I THINK IT WILL BE VERY USEFUL FOR THE NCI TO TAKE A LOOK AT, IT'S VERY THOUGHTFUL IN TERMS OF THOSE OPPORTUNITIES THAT STILL EXIST TO STILL MAKE EVEN MORE PROGRESS IN THIS DISEASE. SO I THINK IT TURNED OUT--IT TURNED OUT QUITE GOOD. >> THANKS, DAVID? NYES, I WAS GOING TO MAKE A BRIEF COMMENT THAT I THOUGHT COMPLEMENTS TO JIM ASK LYNN THAT RECAPITULATION AT 4 OR 5 YEARS WAS REALLY AN INCREDIBLY HELPFUL EXERCISE. IN THE IMAGING WORLD, THERE WASN'T A WHOLE LOT TO OFFER IN TERMS OF TECHNOLOGY WHEN WE STARTED AND 5 YEARS LATER EXISTING TECHNOLOGY LIKE CT HAD GOTTEN BET XER THERE WERE NEW TECHNOLOGIES AND NEW RESULTS COMING DOWN THE LINE FOR BOTH DETECTION AND ACTUALLY BIOMARKERS TO GUIDE SOME OF THE NOVEL THERAPIES. SO I JUST HAD PLEASURE PARTICIPATING IN THE FRONT END OF ANOTHER WE ARE GOING TO TALK ABOUT TODAY AND I WANT TO ENCOURAGE THIS FOLLOW UP, IT'S A COMPLETION OF THE TASK FORCE WHICH OF COURSE WAS VERY VALUABLE AND COMPLEMENT JIM AND LYNN. , THANK --NGLORIA, DO YOU HAVE ANY COMMENTS? NO? IS GLORIA ON BY THE WAY? I CAN'T--ALL RIGHT. ANY OTHER--FOR THE REST OF THE GROUP, ANY OTHER THOUGHTS OR COMMENTS ON THIS REPORT? >> CAN YOU HEAR ME, THIS IS NEAL MARIPOL, I WILL CHIME IN. YEAH, SO I WANT TO ECHO WHAT THE REPORTERS NOTED ABOUT THE GREAT PROGRESS THAT'S CHRONICLED IN THE REPORT OVER A RELATIVELY SHORT PERIOD OF TIME AND THE BIG SCHEME OF RESEARCH TIMELINES, BUT 1 QUESTION I HAD IS RELATED TO THE TREATMET SECTION AND THAT IS WHETHER WE WOULD WANT TO BE MORE EXPLICIT ABOUT HOW FAR WE HAVE TO GO AND THE FACT THAT IN EARLY STAGE PANCREATIC CANCER MOST PEOPLE ARE STILL DYING AND I WONDER WHETHER THERE'S AN OPPORTUNITY FOR THIS AUDIENCE TO HEAR EXPLICITLY THAT WE NEED TO CONTINUE TO HAVE A CALL TO ARMS BECAUSE IN SPITE OF PROGRESS THERE'S STILL A LONG WAY TO GO. AND JIM, I'M JUST WONDERING HOW YOU THOUGHT ABOUT THE WORDING OF THAT SECTION? >> SO NEAL, THANKS IF ARE YOUR QUESTION. BOTH OF THOSE ARE PRACTICING MEDICAL ONCOLOGIST AND OBVIOUSLY DEAL WITH THESE ISSUES EVERY DAY. I'M JUST TRYING TO FLIP BACK TO THE ACTUAL LANGUAGE IN THE REPORT. AND I WOULD BE HARD PRESSED TO DISAGREE WITH YOU THAT PERHAPS WE CAN STRENGTHEN THE LANGUAGE AROUND THE NEED TO CONTINUE TO PUSH FOR FRANKLY, YOU KNOW FUNDING FOR MAKING PROGRESS IN THE CURRENT INITIATIVES THAT ARE ONGOING NOT JUST AT THE IN, CI BUT ACTUALLY WORLD WIDE AROUND PRECISION ONCOLOGY WHICH IS ACTUALLY BECOMING MORE OF A REALITY FOR PANCREATIC CANCER, STATISTICAL A LONG WAYS TO GO. AND MY CONSENT IS THAT WE DO NEED TO CONTINUE TO PUSH OUR BASIC SCIENCE. >> WE JUST LOST YOU, JIM. >> SORRY MY MICROPHONE WENT OFF. WHERE DID YOU LOSE ME? >> BASIC SCIENCE. >> YEAH, SO I THINK YOU KNOW, THE AREAS--I AGREE WITH YOU NEAL, WE CAN LOOK AT THE LANGUAGE, MAKE IT STRONGER, I THINK WE DO HAVE A LONG WAYS TO GO BECAUSE AS YOU POINT OUT MOST PATIENTS WHO PRESENT TODAY EACH WITH EARLY STAGE PANCREATIC CANCER WHO ARE RESECTABLE, THEY WOULD BE OVERALL STATISTICS ARE 8% OF THOSE PATIENTS WILL BE ALIEEVER IN 5 YEARS AND WE'RE NOW LEARNING THAT THERE ARE STILL ARE EVEN LATE RELAPSERS OF PANCREATIC CANCERS 8 AND 9 YEARS AFTER. SO YOU KNOW THIS IS A DAUNTING BIOLOGY AND I COULD NOT AGREE MORE THAT WE CAN LOOK AT THE LANGUAGE AND TRY TO MAKE IT STRONGER. I THINK WE TRIED TO HIT ALL THE AREAS OF OPPORTUNITY BUT YOU KNOW BRINGING THIS TO CONGRESS AND ENCOURAGING ADDITIONAL FUNDING FOR THE NCI TO TACKLE THESE AREAS, I THINK I WOULD BE VERY MUCH IN FAVOR OF THAT. >> JUST TO UNDERSCORE THAT, TOO, I THINK ACTUALLY IN THE CONCLUSION, YOU COULD PROBABLY ADD A COUPLE SENTENCES THERE. CONGRESS MAY SAY HERE'S A NICE REPORT, WE HAVE NOW CONQUERED PANCREATIC CANCER AND NO LONGER NEEDS TO BE PART OF OUR RECALCITRANT CANCERS AND AS YOU KNOW IN 2030 IT WILL BE SECOND CAUSE OF DEATH AND I THINK WE WOULD AMPLIFY THAT AND I THINK IT WOULD HELP WITH THE FUNDING BUT I APPRECIATE THAT. ANY OTHER COMMENTS FROM OTHER PEOPLE? >> I HAVE A COMMENT, THIS IS DEBBARTON, MORE FOR THE FUTURE JUST TO THINK ABOUT BUT GIIVE THE COMPLEXITY OF THIS DISEASE AND THE MORBIDITY AND MORTALITY, I'M WONDERING IF THERE'S A ROLE FOR BEING COMPREHENSIVE IN THE CARE OF THE PATIENT AND LOOKING AT PALLIATIVE CARE EFFORTS, PSYCHOSOCIAL NEEDS ARE THOSE PROPERTILY BEING DELIVERED AT THIS POINT IN TIME WHEN WE HAVE A LARGE PERCENT OF THIS POPULATION, NOT SURVIVING FOR A LONG-TERM IS THE RIGHT CARE BEING GIVEN RIGHT NOW AND WHAT GAPS EXIST THERE. >> I THINK--I THINK IT'S AN EXCELLENT POINT. WE DID HAVE SOME LANGUAGE IN THE REPORT AROUND [INDISCERNIBLE] AND SARK O PENIA THAT ARE--SARCOPENIA THAT ARE A BIOLOGICAL FETAL COMPARTMENT NAMS NAIN PATIENTS WITH PANCREATIC CANCER AND CONTRIBUTE TO THE MORBIDITY OF THE DISEASE. I THINK MY OWN PERCEPTION IS THAT AT NCI COMPREHENSIVE CANCER CENTERS ISSUES AROUND SUPPORTIVE AND PALLIATIVE CARE ARE INCREASING BROUGHT TO BEAR ON ALL PATIENTS WITH ADVANCED, YOU KNOW, METASTATIC CANCER AND CERTAINLY PANCREAS IS 1 OF THOSE. HOWEVER, I'M NOT CONFIDENT THAT THAT'S HAPPENING ACROSS THE BOARD AT NONNCI CENTERS OR IN SMALLER HOSPITALS AND SMALLER SETTINGS. SO YES, I THINK THAT IS AN AREA THAT IS NOT REALLY COVERED IN THE REPORT BUT SHOULD NOT BE OVERLOOKED. I COMPLETELY AGREE. >> ANY OTHER COMMENTS? ALL ARE WELCOME. WELL IF NOT THEN I WILL ACCEPT A MOTION TO ACCEPT THIS PROGRESS REPORT AS IT'S WRITTEN AND JIM, YOU CAN WITH THE MODIFICATIONS THAT NEAL BROUGHT UP, IF WE COULD ADD THOSE, I THINK THE GROUP WOULD BE DELIGHTED. SO I'LL TAKE A MOTION TO ACCEPT AND A SECOND. >> MOVE TO ACCEPT. >> SECOND. >> PERFECT. PERFECT. WE'LL TAKE A VOTE, ANY DISSENSIONS ON THIS? IT'S EASIER TO DO IT THAT WAY THAN TO TAKE A VOTE. IF NOT THIS WAS UNANIMOUSLY PASSED. JIM, AGAIN I WANT TO CONGRATULATE YOU AND LYNN AND DAVID AND GLORIA AND ALL THE MEMBERS OF THE GROUP. I THINK THIS IS REALLY A MODEL, JUST A MODEL REPORT AND A TERRIFIC EFFORT. THANK YOU FOR YOUR EFFORTS. >> THANK YOU, THANKS FOR BEING A PART OF THIS MEETING THIS MORNING. >> GREAT. WELL, LET'S MOVE ON, NOW, SO THERE'S ANOTHER RESEARCH WORKING GROUP WHIH IS THE PROGRESS IN SMALL CELL LUNG CANCER. THIS IS A COMMITTEE THAT WAS CHAIRED BY DR. ALEX ADJEI, AND DR. LORI GASPARAND THEY ARE ALSO JOINING US FOR THIS MEETING. THEY WILL GIVE A REPORT. THIS 1 WILL BE MORE LIKE WHAT JIM GAVE BACK IN OUR FALL MEETING, THE PURPOSE OF THIS SESSION IS TO PROVIDE THE MEMBERS WITH AN UPDATE OF THE ACTIVITIES OF THIS PROGRESS IN SMALL CELL LUNG CANCER RESEARCH WORKING GROUP. THIS GROUP WAS CONVENED IN THE RELEVANCE OF INITTIAIVE ITS IN THE SMALL CELL LUNG CANCER SCIENTIFIC FRAMEWORK THAT WAS DEFINED 5 YEARS AGO AND TO HELP OOH DENT ANY NEW RESEARCH OPPORTUNITIES IN THIS DISEASE. THE FINDINGS OF THIS GROUP WILL ASSIST THE NCI IN UPDATING THE SMALL CELL LUNG CANCER SCIENTIFIC FRAMEWORK WHICH IS ALSO DUE TO CONGRESS IN JUNE OF THIS IN RESPONSE TO THE SAME RECALCITRANT CANCER RESEARCH ACT OF 2012. RESPIRATORY THE COCHAIRS WILL PRESENT A SUMMARY OF THIS MEETING IN FEBRUARY, THE CTAC MEMBERS DAVID MANK OFF AND DR. SOLAR ARE PART OF THE WORKING GROUP. THE FINAL REPORT WILL BE RECIRCULATED PROBABLY AROUND IN A FEW MONTHS. THE CTAC MEETS IN JULY, IT'S DUE IN JUNE SO WE WILL HAVE TO HAVE A FINAL REPORT DONE BY E-MAIL SO WE HAVE ABOUT 20 MINUTES FOR PRESENTATION SO ALEX AND LAURIE GO AHEAD. >> HI, CAN PEOPLE HEAR ME? IT'S LAURIE GASP A R. >> YES. >> THANKS BECAUSE I JUST--FYI, FOR SOME REASON I LOST THE VIDEO BUT I HAVE THE SLIDES AND I'LL BE HAVING THEM ADVANCE FOR ME, SO LET ME KNOW IF IT'S NOT WORKING BUT RIGHT NOW YOU ARE SEEING THE TITLE SLIDE ABOUT OUR WORKING GROUP UPDATE FOR 2019. >> YES. >> I THINK YOU ALREADY EXPLAINED ALL THAT SO NEXT SLIDE. SO AS PART OF OUR TALK, WE WILL GIVE A LITTLE BIT OF BACKGROUND ON SMALL CELL LUNG CANCER, TALK ABOUT THE SCIENTIFIC FRAMEWORK THAT WAS DEVELOPED IN 2014 AND THEN CONTINUE ON OF COURSE WITH THE RECENT SCIENTIFIC CLINICAL ADVANCES AND SUMMARIZING WHAT HAPPENED AT OUR FEBRUARY 4, 2019 WORKING GROUP MEETING WHICH WAS A FACE-TO-FACE MEETING AND THEN WITH CONCLUSIONS AND DISCUSSION OF NEXT STEPS. NEXT SLIDE. SO LUNG CANCER CONTINUES TO BE A MAJOR PROBLEM IN THE UNITED STATES, SMALL CELL LUNG CANCER MAKES UP ABOUT 14% OF LUNG CANCER IN GENERAL WHICH LUN OF LUNG CANCER HAS BEEN DECREASING AS SMOKING AS PERHAPS DECREASED BUT NEVERTHELESS, LUNG CANCER IS STILL A PROBLEM FOR POPULATION IN PARTICULAR, MEN, NONHISPANICS VERSEERCEUS HISPANICS ACCIDENT NONMETROPOLITAN COUNTIES AND AREAS OTHER THAN THE WEST. NEXT SLIDE. SO SMALL CELL LUNG CANCER IS STILL A RECALCITRANT CANCER IN 2019. IT CLAIMS APPROXIMATELY 30,000 LIVES PER YEAR, EQUALLY FOR MEN AND WOMEN. THE 5 YEAR SURVIVAL OVER ALL IS LESS THAN 7 PERCENT AND THE TREATMENT OVER THE LAST 35 YEARS HAS CHANGED VERY LITTLE. IT'S BEEN PRIMARILY A COMBINATION OF CHEMO THERAPY AND SOMETIMES RADIATION THERAPY BUT THE RECENT ADVANCEIN 2018 WAS THE ADDITION OF CHECK POINT INHIBITORS OR IMMUNOTHERAPY AS IT'S SOMETIMES REFERRED TO. SO THE PROBLEM IS WITH SMALL CELL LUNG CANCER THAT THERE'S AN INITIAL RESPONSE TO CHEMO THERAPY WITH OR WITHOUT RADIATION BUT IT'S GENERALLY SHORT LIVED AND FOLLOWED BY RECURRENCE AND WE HAVE INCREASED AVAILABILITY OF MATERIALS. BY THAT I MEAN TISSUE BIOPSIES OR OTHER SAMPLES FROM TUMORS THAT HAVE REALLY BYE-BYE THE BACKBONE OF RESEARCH IN OTHER TYPES OF CANCERS AND WE HAVE REALLY HAD PROBLEMS WITH DIAGNOSIS AND SMALL CELL LUNG CANCER AT AN EARLY STAGE SO FAR SCREENING EFFORTS WITH THE USUAL--CAT SCAN, APPROACHES HAVE NOT--HAVE NOT BEARED FOREIGN TRIEWT SO THE NEXT SLIDE, IN 2014, HERE'S THE SCIENTIFIC FRAMEWORK THAT WAS DEVELOPED WITH THE FOLLOWING 5 RECOMMENDATIONS, THAT WE NEEDED BETTER RESEARCH TOOLS FOR THE STUDY OF SMALL CELL LUNG CANCER, WE COULD DO THIS BY OPTIMIZING COLLECTION OF TUMOR TISSUES AT DISTINCT PHASES, THAT IS DIAGNOSIS PERHAPS AT RECURRENCE AND EVEN AT DEATH AND AUTOPSIES PESMENS THAT WE NEEDED NEW TUNER MODELS FROM VARIOUS SOURCES AND THEN THE SECOND POINT WAS THAT THAT WE NEEDED TO HAVE MORE COMPREHENSIVE GENOMIC PROFILING IN THE SMALL CELL LUNG CANCER AND THIS SHOULD BE COMBINED WITH CLINICALLY ANNOTATED INFORMATION SO THAT WE CAN IMPROVE THE BASIC UNDERSTANDING OF THE FREQUENCY DISTRIBUTION AND RANGE OF MOLECULAR ABNORMALITIES THAT EXISTED ALL POINTS IN THIS DISEASE. WE ALSO NEED NEW DIAGNOSTIC APPROACHES FOR SMALL CELL LUNG CANCER TO TRY TO FIND NEW WAYS OF FINDING THIS CANCER AT AN EARLIER STAGE IN POPULATIONS AT HIGH RISK OF DEVELOPING IT. THE NEXT POINT IS THAT WE NEED TO IMPROVE OUR THERAPEUTIC QUEPMENT EFFORTS--DEVELOPMENT EFFORTS TO FOCUS ON SPECIFIC MOLECULAR VULNERABILITIES, SMALL CELL LUNG CANCER WHICH ARE LISTED THERE. NONETHELESS, THE RECOMMENDATION WAS TO RESEARCH MECHANISMS UNDER LYING BOTH THE HIGH RATE OF INITIAL RESPONSE IN THE RAPID EMERGENCE OF DRUG AND RADIATION RESISTANCE. NEXT SLIDE. SO OUR WORKING GROUP MEMBERS ARE LISTED HERE AND AS WAS ALREADY MENTIONED WE HAVE SEVERAL OF THEM ON THIS CALL. DR. ALICE ADJACE AND I WERE CO CHAIRS, BUT THESE ARE MEMBERS WHO ARE WELL REGUARDED IN THE FIELD OF SMALL CELL LUNG CANCER AND WE HAVE MEMBER WHO IS ARE MEDICAL ONCOLOGISTS, PATHOLOGIST, RADIOLOGYST, BASIC SCIENTISTS, ET CETERA. AND THEN ON THE--WE ALSO HAD A STRONG GROUP OF NIH LIAISONS LISTED HERE WHICH WE'RE VERY CRITICAL FOR THE WORKING OF OUR GROUP. NEXT SLIDE. SO, THE 2019 UPDATE, WE HAD A SERIES OF PHONE CALLS, WEBINARS IN JANUARY OF THIS YEAR, AND THEN AN IN-PERSON MEETING IN FEBRUARY OF 2019 AND THE MANDATE& TO OUR WORKING GROUP WAS TO PROVIDE AN UPDATE OF THE KEY ADVANCES IN THE LAST 5 YEARS AND TO ASSESS THE CONTINUED RELEVANCE OF THE INITIATIVES THAT HAVE BEEN DEVELOPED IN 2014. AND REALLY THE HEART OF IT IS TO DISCUSS THE PROGRESS AND ARE WE ON TRACK WITH OUR EFFORTS. AND THE INFORMATION PROVIDED BY THE NCI TO US AS THE WORKING DPROWP ARE LISTS HERE IN TERMS OF GRANTS, CLINICAL TRIALS AND IMPORTANT PUBLICATIONS IN THE FIELD. AND WE'RE GOING TO BE PROVIDING A REPORT, WITH THE 5 YEAR UPDATE TO CONGRESS BY JUNE 30th 2019. NEXT SLIDE. AT THIS POINT THEN I WILL HAND IT OVER TO DR. ADJEI. >> YES, SO WE MET FOLKS AT NCI AND THAT I HAVE GAVE UPDATES ON THE SMALL CELL CONSORTIUM THAT I WILL DESCRIBE LATER [INDISCERNIBLE] GAVE UPDATES ON TUMOR PROJECTS AND THEN WE HAD 4 PLANNING GROUPS AND LEADERS GAVE PRESENTATIONS SO WE STARTED OFF BY REVIEWING THE PROGRESS THAT'S BEEN MADE OVER THE LAST 5 YEARS. NEXT SLIDE. NEXT SLIDE. SO WE GROUP THESE AND OTHER SCIENTIFIC FRAMEWORK THEMES AND SO, INITIATIVE 1 WAS LOOKING AT THE RESEARCH TOOLS FOR THE STUDY OF SMALL CELL LUNG CANCER AND A FAIR AMOUNT OF PROGRESS HAS BEEN MADE. ONE THEY'RE GENETICALLY ENGINEERED MOUSE MODELS FOR SMALL CELL LUNG CANCERS THAT ARE AVAILABLE AND 1 OF THE MORE IMPORTANT ADVANCES WAS THE ABILITY TO ACTUALLY CAPTURE CIRCULATING TUMOR CELLS FROM BLOOD AND GROW THEM IN IMMUNE O DEFICIENT MICE TO GENERATE THE SO CALLED CTXs WHICH ARE REALLY LED TO SIGNIFICANT IMPROVEMENT IN MODELS FOR TESTING NEW DRUGS AND VALID PROCESSES AND ALSO A COMPREHENSIVE DRUG SCREEN OF ABOUT 63 SMALL CELL LINES. USING 123 APPROVED DRUGS AS WELL AS OVER 400 INVESTIGATIONAL RESEARCH AND IN LOOKING AT RESPONSE TO THESE DRUGS AND GENE AND MICRORNA SUPPRESSION, SMALL SUBTYPES COULD BE IN A GROUP THAT IS [INDISCERNIBLE] CATEGORIES AND THESE WERE SUPPORTED BY GENETIC STUDIES ALSO THAT I STRIEB IN THE INITIATIVE IN THAT SLIDE. SO WHAT YOU SEE HERE INITIATIVE TO LOOKING AT GENOMIC MODELS, 1 OF THE FUNDAMENT AMILLIO CHANGES THAT'S OCCURRED IN THE STANDARD OF THIS DISEASE IS THE FACT THAT 1 CAN ACTUALLY GROUP THIS DISEASE INTO DIFFERENT SUBSETS BASED ON SOME GENOMIC MARKERS OF LESS THAN A VERY DOMINANT 1S, CO-1 NEURO1 AND F3, AND THESE REALLY ARE CATEGORIZING THESE DISEASES INTO FAIRLY DISTINCT SUBTYPES GIVING US SOME SENSE AS TO HOW TREATMENTS HAVE BEEN REALATIVELY INEFFECTIVE BECAUSE WE'VE BEEN TREATING ALL SMALL CELL AS THE SAME AND [INDISCERNIBLE] ACTUALLY DIFFERENT DISEASES. NEXT SLIDE. AND IN TERMS OF DIAGNOSTIC APPROACHES, THE SIGNIFICANT ADVANCE HERE HAS BEEN THIS PATTERN OF EFFORTS TO LOOK AT CIRCULATING TUMOR DNA AS A MEANS OF EARLY DETECTION OF THIS DISEASE, NEXT SLIDE. THERE HAVE BEEN A NUMBER OF ADVANCES ON THE THERAPEUTIC FRONT, THE FIRST HAS BEEN UNDERSTANDING THAT THE DNA REPAIR PATHWAY MEANING THAT THE NUMBER OF TARGETS HERE, THE PATH, CHECK 1, WE WANT THE ATM THAT WE COULD ACTUALLY ADDRESS WITH DRUGS AGAINST THESE TARGETS, HOWEVER WHAT WE FOUND IS THAT AT LEAST IN THE EARLY STAGES AND NOT ALL THESE APPROACHES HAVE WORKED QUITE WELL AND ADDRESS THAT LATER. THE OTHER ADVANCE HAS BEEN IN IMMUNOTHERAPY WHERE HE ALSO THE NEWS, THE GOOD NEWS IS THAT FOR THE FIRST TIME WE HAVE THAT WITH THE TOZULUMAB, AND COMBINE WIDE CHEMO THERAPY FOR ADVANCED STAGE DISEASE AND WE ALSO RECOGNIZE TLR 3 AND THE FAMILY AS A POTENTIAL TARGET AND NEXT SLIDE? AND WAWE FOUND IS THAT THIS STUDY, EMPOWER 13333 IS THE ATZUMOLAB CHEMO THERAPY WHICH HAS BEEN THE FIRST NEW TREATMENT FOR THIS DISEASE IN OVER 35 YEARS BUT THERE WAS ANOTHER STUDY WHERE NOVOLUMAB WAS COMPARED TO TOP O TIARAS KAN--KANA FOR SMALL CELL LUNG CANC XER THIS WAS A NEGATIVE STUDY. A SECOND STUDY WHERE AN ANTIBODY DROPPED CONJUGATE THAT GIVES TLR 3 WAS TESTED AND THAT WAS ALSO NEGATIVE. REALLY GIVEN THEM TO THE IMPORTANCE OF FIFTH INITIATIVE WHICH IS LOOKINGA THE RESISTANCE, PLEASE, NEXT SLIDE. SO FOR INSTANCE 1 OF THE MORE EXCITING THINGS HAS BEEN THIS PROTEIN [INDISCERNIBLE] SO IT TURNS OUT THAT EXPRESSION OF THIS PROTEIN IDENTIFIES A GROUP OF SMALL CELL LUNG CANCER PATIENTS WHO MIGHT BENEFIT FROM POP AND THERE HAS BEEN A STUDY WITH A COMBINATION OF [INDISCERNIBLE] THAT SHOW A NICE PROOF OF CONCEPT HERE. SO BASICALLY UNDERLYING THE IDEA THAT WE KNOW DNA DAMAGE IS IMPORTANT BUT STUDIES HAVEN'T ALWAYS [INDISCERNIBLE] AND THIS [INDISCERNIBLE] MECHANISMS IS VERY IMPORTANT AND THEN MORE IMPORTANTLY, THERE HAVE BEEN GENOMIC PROFILING OF REFRACTORY SMALL CELL SAMPLES. THIS IDENTIFIED WITH THE SIGNALING AS A MAJOR MEANS OF MEDIATION OF RESISTANCE, AND SO IN SUMMARY, NEXT SLIDE, NEXT SLIDE. WE FELT LIKE THE NCI HAS RESPONDED TO ALL 5 INITIATIVES AND I WILL TALK ABOUT THE CONSORTIUM IN A MINUTE AND A NUMBER OF GRANTS THAT I WILL SHOW HAVE BEEN AWARDED. THERE'S BEEN AN INCREASE IN THE NUMBER OF GERONTOLOGYSTS AM NONAPOPTOTICKIC STUDIES AND WE NOW HAVE INCREASED UNDERSTANDING OF SUBSTANCE OF SMALL CELL MECHANISMS OF RESISTANCE, WE HAVE TUMOR MODELS AND THERE HAVE BEEN AT LEAST EARLY EXAMPLES OF EFFECTIVE NEW TREATMENTS AND HOWEVER A LOT OF WORK NEEDS TO BE DONE SO WE FEEL THE CURRENT SET OF INITIATIVES REMAIN IMPORTANT. NEXT SLIDE. SO OUR RECOMMENDATIONS THAT RESTILL HAVE A LONG WAY TO GO IN TERMS OF SAMPLE ACQUISITION. AND SO A ACCORD MECHANISMS NEED TO CONTINUE. THIS CAN BE DONE IN THE CONSORTIUM AS WELL AS IN OTHER CANCER CENTERS, THE BIGGEST AREA OF NEED IS LINKED STAGE DISEASE, METASTASIS AND REFRACTORY PATIENTS BECAUSE MOST ACQUISITION OF TISSUE IS EARLY DIAGNOSIS AND THOSE ARE THE PATIENT WHO IS ACTUALLY RESPOND TO THERAPY AND THE BIGGEST PROGRAM WITH THESE DISEASES THAT FOLKS WILL RELAPSE AND GREATER EFFORTS NEED TO BE MADE TO TAKE A GLOBAL VIEW OF THIS DISEASE LOOKING AT TRANSCRIPTION OHM EPIGENOMIC METRICS TAB O LOAM AS WELL AS THE TUMOR MICROENVIRONMENT AND A LOT OF EFFORT NEEDS TO BE PUT INTO BLOOD BASED SCREENING AND IMAGING APPROACHES, SO GETTING SAMPLES IN THIS DISEASE AS BEEN QUITE DIFFICULT. NEXT SLIDE. SO THIS IS A QUICK OVERVIEW OF INITIATIVES THAT NCI HAS PUT IN PLACE TO FEATHER NAMES OF THE SCIENTIFIC FRAMEWORK. SO IN ALL THESE 5 AREA THERE HAVE BEEN NEW GRAPT MECHANISMS. NEXT SLIDE. SO ITEMS 4 AND 5, THERE'S A U1 LOOKING AT THERAPEUTIC DEVELOPMENT AND MECHANISMS OF RESISTANCE, NEXT SLIDE. INITIATIVE 3, THERE'S A U1 LOOKING AT PREVENTION AND EARLY DETECTION. NEXT SLIDE. AND TO GET SAMPLES AND PROFILE THEM AND SO ON, THERE'S A U24 COORDINATING CENTER THAT IS BRINGING ALL OF THESE GROUPS INTO FOCUS. NEXT SLIDE. SO LAURIE WILL FINISH OFF WITH THE CONSORTIUM [INDISCERNIBLE] AND FINAL COMMENTS. >> THANK YOU DR. ADJEI, ARE PEOPLE ABLE TO HEAR ME STILL? OKAY, GOOD, THANKS OKAY, SO YOU'RE SEEING THE LIST HERE OF THE SMALL CELL LUNG CANCER CONSORTIUM MEMBERS FROM AROUND THE COUNTRY, VARIOUS INSTITUTIONS AND THE NEXT SLIDE, PLEASE? SO, THIS CONSORTIUM WAS DEVELOPED REALLY OPERATING IN A VERY COORDINATED EFFORT TO LOOK AT VARIOUS ASPECTS OF SMALL CELL LUNG CANCER AND I WON'T GO THROUGH ALL THESE DIFFERENT GRANTS AWARDED BUT THEY ADDRESS VARIOUS ASPECTS OF THE DISEASE FROM METASTASIS TO BLOOD BASED DETECTION, ET CETERA. AND THEN THERE'S THE COORDINATING CENTER WHICH IS AT THE HUB OF THIS AND I SHOULD RECOGNIZE THE FACT THAT THE NCI HAS REALLY COORDINATED THIS EFFORT ALONG WITH SOME SUPPORT FROM THE MEETING FOR THE ISLC, THE INTERNATIONAL STUDY OF SMALL CELL LUNG CANCER WITH THE MEETING HELD LAST YEAR. NEXT SLIDE, SO AT THE HUB IS THE COORDINATING CENTER WHICH IS COORDINATED AT NCI, THROUGH THE HELP OF DRS. [INDISCERNIBLE] BUT THERE'S THE OTHER CENTERS LISTED HERE, UT SOUTHWESTERN LOOKING AT SAMPLES, AND VANDERBILT LOOKING AT CLINICAL CORE DATABASE EFFORTS, TISSUE MICROARRAYS FROM CASE WEST EXPERN MODELING DONE AT BOTH MASS GENERAL AND MEMORIAL. THIS SLIDE YOU'RE LOOKING AT SHOULD BE ABOUT GRANTS AWARDED WHICH ARE REALLY LOOKING MORE AT TREATMENT AND EARLY DIAGNOSIS. SO I THINK WE WILL HAVE A LOT OF GOOD INFORMATION TO REPORT ON AND COMMENT ON AS THESE GRANTS COME TO FRUITION SO NEXT SLIDE, THERE'S ABOUT 47 GRANTS IN TOTAL THAT HAVE BEEN AWARDED IN THE AREA OF SMALL CELL LUNG CANCER BUT THIS HAS TO BE COMPARED WITH THE GRANTS IN 2012 SO WE'VE COME A LONG WAY. >> NEXT SLIDE SO ALTHOUGH WE FEEL THAT WE'RE ON TRACK AND THE INITIATIVES FROM 2014 ARE STILL RELEVANT, WE IDENTIFIED GAPS AND OPPORTUNITIES WHICH WE FELT WE SHOULD POINT OUT, WE NEED COORDINATED MECHANISMS FOR SAMPLE ACQUISITIONS, STORAGE AND CHARACTERIZATIONUANT COMA IS CURRENTLY ASSOCIATED WITH THE SMALL CELL LUNG CONSORTIUM AND PERHAPS MANDATING BIOPSIES WITHIN A SMALL CELL LUNG CANCER MASTER CODE OF CALL. OR FUNDING FOR RAPID AUTOPSIES PROGRAMS AND ENHANCED BIOINFORMATIC RESOURCES, AS WELL WE NEED INCREASED SAMPLE COLLECTIONS AT VARIOUS STAGES WE NEED GREATER ADVANCES TO INVESTIGATE EPIGENOME, MICROBIOME AND SMALL CELL ENVIRONMENT OF LUNG CANCER. WE NEED INCREASES FOR RESOURCES AND SHARING OF CELL AND MOUSE MODELS. AND INCLUDING THE REQUIREMENT FOR CLINICAL ANNOTATION WHERE IT'S AVAILABLE. AND WE NEED DEVELOPMENT OF MODELS FOR IMMUNOTHERAPY WHICH AS WE MENTION SIDE 1 OF THE NEW TREATMENTS AVAILABLE. AND WE HAVE CONTINUED EFFORTS FOR BLOOD BASED AND IMAGING APPROACHES FOR SCREENING AND EARLIER DIAGNOSIS AND WE NEED 92 YOU APPROACHES TO PRO VENTION. NEXT SLIDE, SO, THIS IS ALL GOING TO LEAD TO A REPORT OF THE WORKING GROUP WHICH WILL BE CIRCULATING TO YOU AND THEREFORE PROVIDE UPDATE TO CONGRESS BY THE DEADLINE OF JUNE 30th 2019. THANK YOU. >> TERRIFIC, THANK YOU BOTH FOR PRESENTING THIS. THE FLOOR IS OPEN NOW FOR QUESTIONS OR FURTHER DISCUSSION. >> PAT I WILL COME IN SENSE I'VE BEEN ON THE COMMITTEE, I'VE BEEN DOING COMMITTEE WORK LATELY BUT COMING BACK TO THIS TOPIC AGAIN I WASN'T PART OF IT, THE FIRST TIME WAS REALLY HELPFUL AND HERE AGAIN THE TECHNOLOGY HAS ADVANCED. IN PARTICULAR, THIS IS AN AREA WHERE THERE'S A LOT OF IMAGING INFORMATION FROM THEM ON THE NATIONAL LUNG CANCER SCREENIG TRIAL BUT THERE'S NOT A LOT OF SMALL CELL THERE AND THE SCREENING WASN'T PARTICULARLY SUCCESSFUL FOR SMALL CELL. SO GOOD DISCUSSION ABOUT HOW TO LEVERAGE THAT EFFORT AND THINK ABOUT EARLY DETECTION TECHNIQUES INCLUDING TAKING ADVANTAGE OF COMPUTERIZED TECHNIQUES, AND I AGAIN, I THINK AFTER THE PANCREATIC DISCUSSION, THERE ARE ACTUALLY REALLY NICELY EMERGING APPROACHES FOR USING IMAGING BIOMARKERS TO HELP GUIDE THE THERAPYINGS THAT WERE MENTIONED SO APPRECIATED BEING PART OF IT AND WHAT AN ACCOMPLISHMENT FOR THE LEADERS. >> GREAT PRESENTATION, SO SO THINK HAPPENING ABOUT THE THIS REPORT AND WHAT THE NATIONAL CANCER INSTITUTE COULD DO WITH THE SMALL CELLS IS HOW DO YOU CAPITALIZE ON WHAT'S GOING ON IN INDUSTRY NOW THAT THERE'S A BREAK THROUGH STUDY, THERE WILL BE A LOT OF INVESTMENT IN NEW IMMUNE O ONCOLOGY PRODUCTS IN SMALL CELL, PROBABLY IN SCIENCE RELATED TO IT SO HOW CAN YOU SUGGEST THAT THE FEDERAL SUPPORT OF CANCER RESEARCH LEVERAGE THIS INCREASED ACTIVITY? >> THIS IS LAURIE BUT DR. ADJAI PROBABLY HAS AN ANSWER, TOO, BUT THE THORACIC STEERING COMMITTEE, I THINK WHAT WE'RE SEEING OFTEN IS ARE STUDIES THAT ARE NCI FUNDED IN PARTNERSHIP WITH SUPPORT FROM COMPANIES TO PROVIDE DRUG AND PERHAPS OTHER TRANSLATIONAL STUDIES ET CETERA BECAUSE AS YOU POINT OUT IT HAS TO BE A JOINT EFFORT, PERHAPS. >> YES, THIS IS ALEX CAN YOU HEAR ME,. >> YES, SO AS LAURIE SAID THROUGH THE NCTN, THEIR NUMBER OF ONGOING STUDIES IN SMALL CELL CAPITALIZING ON THE LSU, ACTUALLY SAID THE INTEREST OF INDUSTRIES SO MOST OF THESE AS YOU WELL KNOW HAVE THE COMPOUNDS COMING FROM INDUSTRY AND BEING PARTNER WIDE TO DO THE STUDIES AND THE INTERESTING THING AND I THINK WHAT'S STRIKING ABOUT THESE NCTNs, IS THERE A LOT OF BIOMARKERS ARE BUILT IN LOOKING AT THEM IN THE INDUSTRY, TYPICALLY FOR THEM TO LOOK AT AND A FAIR AMOUNT OF TISSUE COLLECTION AND SO ON SO I THINK A LOT OF THIS WORK IS IS UNDERWAY IN THE CORPORATE CAUSE. >> IS ROMAN ON THE CALL? >> YES, I AM NYOU WERE ON THE PARTY, WOULD YOU LIKE TO MAKE COMMENTS? >> YES, FIRST I WANT TO CONGRATULATE ALEX AND LAURIE, THEY PUT TOGETHER A FANTASTIC MEETING AND I WAS EXTREMELY IMPRESSED BY THE SCIENTIFIC PROGRESS AND UNDERSTAND THE BIOLOGY AND NOW WE KNOW IT'S SO COMPLICATE THAD WE HELLS YOU THAT IT'S GOING TO TAKE A LOT OF EFFORT TO REALLY FIND SOMETHING THAT WILL MAKE AN IMPACT HERE. BUT AFTER I LEFT THE MEETING, I THOUGHT THAT MAYBE SINCE THIS WOULD BE A REPORT FOR CONGRESS, POLITICIANS AND THESE DISEASES PRODUCED BY TOBACCO THAT WE MUST REPEAT AND REPEAT THAT THIS WOULDN'T EXIST IN THE BACK OF THESE, 98% OF THESE ARE DUE TO TO BACK O SO I THINK WE SHOULDN'T PUT THIS IN THE REPORT THAT THESE ARE RECALCITRANT DISEASE AND THE DISEASE AND THAT IS AN EASY WAY TO BASICALLY [INDISCERNIBLE] AND I SUPPOSE WE ALL KNOW THAT BUT BECAUSE THESE GO TO POLITICIAN THAT I THINK WE NEED TO EMPHASIZE THAT. SO THAT WAS MY THOUGHT WHEN I LEFT THE MEETING THAT WE SHOULD BE VERY STRONG IN EMPHASIZING THAT. , YEAH, ROMAN, I AGREE AND AS YOU KNOW, YOU KNOW WE SPENT A GOOD BIT OF TIME AT OUR FEBRUARY MEETING TALKING ABOUT SMOKING CESSATION OR WHAT WILL HAPPEN AS THE WORLD OF E-CIGARETTES HAS EXPLODED SO I THINK WE SHOULD TRY TO WORK IN SOMETHING ABOUT THAT. >> WELL THIS IS THE REPORT BECAUSE AS YOU KNOW THERE'S NOTHING THERE TO DO THESE THINGS BUT I THINK THE POLITICIANS SHOULD KNOW AND EMPHASIZE THAT THIS DISEASE WOULD NOT EXIST IF THERE WAS NO TOBACCO BECAUSE BASICALLY [INDISCERNIBLE] TOBACCO USE. >> YEAH. YEAH, I HEAR YOU. >> THIS IS LYNN AND IF I COULD JUST ADD I WAS STRUCK BY THE EMPHASIS ON TRANSLATIONAL RESEARCH BUT THAT REALLY SEEMED TO BE WHERE THE FOCUS WAS AND THAT THERE WASN'T A LOT OF WAS THERE DISCUSSION ABOUT PERHAPS THE CLINICAL TRIALS BEING DONE AND THE STRUCTURE OF THEM AND THEN INTO CLINICAL CARE AND PALLIATIVE CARE AND SUPPORTIVE CARE FOR THESE PATES, IS THERE AN OPPORTUNITY TO ADD THAT TO THE REPORT FOR A--YOU KNOW TO KIND OF PUT SOMETHING AT THAT END OF THE SPECTRUM AS WELL? >> YEAH, THIS IS ALEX, I THINK--AND ROMAN YOU MAY COMMENT ON THAT BECAUSE THAT MEETS A HUGE PART OF THE FOCUS ON TRANSLATIONAL RESEARCH. WE BROUGHT UP SOME ISSUES ABOUT CLINICAL RESEARCH, THE BIG ISSUE IN BEST DISEASES THAT WE GET A LOT OF RESPONSES UP FRONT AND THEN IN THE REFRACTORY SET AND WE ACTUALLY DON'T DO WELL, AND THERE HAVE BEEN A LOT OF FAILED TRIALS AND IN MOST OF THOSE TRIALS. WE DON'T UNDERSTAD WHY THAT TRAIL'S FAILED. SO PART OF THE FOCUS ON TRANSLATIONAL RESEARCH IS WE HAVE TO DO A BETTER JO BE OF COLLECTING SAMPLES, GETTING BIOMARKERS, SO THAT WE DO UNDERSTAND WHY STUDIES [INDISCERNIBLE] DON'T WORK. WE ALSO TALKED A LITTLE BIT ABOUT MAYBE THE IDEA OF [INDISCERNIBLE] SO IT WOULD NOT BE SO MUCH COLLABORATION LOOKING AT THE MULTIPLE DIFFERENT TARGETS AND BE ABLE TO SET UP TO BE ABLE TO GET PRE- AND POST BIOPSIES AND SAMPLES TO TRY TO UNDERSTAND THIS DISEASE, I ALSO HAVE TO ADD I MENTIONED THAT NCTNAND THE ACTN ALSO HAS BEEN [INDISCERNIBLE] SOME OF THESE INNOVATIVE STUDIES SO A LOT OF THE DNA DAMAGE RESPONSE WORK AND THE LE IMMUNOTHERAPY WORK HAS BEEN THROUGH THE UM 1 MECHANISM. >> I COMMENT I WAS GOING TO MAKE, WHAT A GREAT JOB DID, I THINK CONGRESS WILL LISTEN TO IT AND I THINK IT IS A GREAT OPPORTUNITY TO GET A LITTLE BIT ON THE BULLY PULPIT FOR TOBACCO AND I WAS THINKING ABOUT THE ALL THE TOBACCO RELATED MALIGNANCIES THIS IS LIKE THE BURKEETS LYMPHOMA OF THE DISEASE, SO THIS IS THE MOST AGGRESSIVE TUMOR ASSOCIATED WITH TOBACCO, THERE MAY BE OTHERS BUT I THINK IT'S IMPORTANT TO RECOGNIZE THAT. POINT NUMBER 2 IS WHEN I THINK THIS--YOU ALLUDED TO THE INTRODUCTION BUT THERE IS A TAIL OF THE CURVE OF SURVIVORS IN SMALL CELL LUNG CANCER, 35 YEARS AGO,ULARY WOULD GIVE A TALK TO INTESTINES CANCER AND WE WOULD THEN REFLECT ON SMALL CELL HAVING THE SAME KIND OF TAIL, UNFORTUNATELY THE TAIL HAS BEEN THE SAME OVER THE LAST 35 YEARS. BUT I DO THINK A FOUL UP, A NOT TO DOING LONG NUDEINAL EVALUATION OF SURVIVORS WITH SMALL CELL, 1 TO SEE THESE MAGIC PATIENTS OR EXCEPTIONAL PATIENTS TO FIND OUT THE BIOLOGY IN THOSE PATIENTS COMPARED TO THE VAST MAJORITY OF PATIENTS UNCURED WOULD BE A NICE OPPORTUNITY. AND AND THEN THE 30-POINT--I THINK WHAT THE PANCREATIC GROUP DID THAT WAS VERY NICE IF TERMS OF THE RESEARCH GAPS AND OPPORTUNITIES IN WHICH THEY SEGREGATED THE RESEARCH GAPS WITH THE RESEARCH OPPORTUNITIES AND I THINK IF YOU MIGHT THINK ABOUT THAT AS YOU WRITE YOUR REPORT BECAUSE I THINK IN THE CONCLUSION SLIDE, THEY WERE MIXED IN TOGETHER AND IT WOULD BE NICE TO SEPARATE MEN AND WOMEN ARE THE RESEARCH ISSUES OF THE FUTURE AND HOW ARE WE WITH GOING TO ATTACK IT BUT WHAT ARE THE SPECIFIC GAPS THAT ARE ONGOING THERE. ANY OTHER COMMENTS? >> THIS IS DEB, I HAVE MORE MAYBE OF A QUESTION HOW MUCH DO WE KNOW ABOUT THE POPULATION THAT INN FORMS THE DATA AND THE EVIDENCE TO DATE ABOUT THE BIOLOGY AT FLETCHER, IS IT A DIVERSE POPULATION OR A HOMOGEANIOUS POPULATION FROM A HELT DISPARITIES DIVERSITY PERSPECTIVE. >> WELL, THIS IS LAURIE, I THINK FROM LAWN MOWER I HEARD AT OUR FEBRUARY MEETING WE HAVE A GENERAL LACK OF SPECIMENS COMPARED TO OTHER LUNG CANCERS AND SO IT'S PROBABLY TRUE THAT MOST OF THEM ARE AT FIRST DIAGNOSIS AND THEREFORE THEY'RE PROBABLY IN A VERY DIVERSE GROUP OF DIAGNOSIS PERHAPS AS REFLECTS DISEASE BUT PERHAPS IT'S MORE COMMENT TO DO STUDIES IN PEASHTS WHO ARE PRESENTED TO ACADEMIC CENTERS THAT MAY NOT BE SUCH A DIVERSE GROUP AS WE WOULD LIKE TO SEE. ALEX WOULD YOU LIKE TO MAKE ANY COMMENT? >> YEAH, IN GENERAL, WHAT'S HAPPENED HAS BEEN SOME OF THE EARLY STUDIES AND TO BE IN GROUPS THAT ARE NOT REALLY [INDISCERNIBLE] AND THE BIGGER STUDIES THEN GOES INTO A DIVERSE GROUP. AND WE TALK ABOUT THAT [INDISCERNIBLE] THAT GENERATED A LOT OF EXCITEMENT IN THE EARLY STAGES OF DEVELOPMENT OF PHASE 1 AND SO THE RESPONSE IS REALLY ROBUST AND THEN WHEN WE WENT TO A LARGER POOL, THERE WAS A LOT MORE [INDISCERNIBLE]. SO THAT HABIT BEEN SEEN [INDISCERNIBLE]. SO WE TALK ABOUT THE NEED TO DETAILS A MORE [INDISCERNIBLE] THAT WE DEVELOP THESE DRUGS AND AS LAURIE ALLUDED TO, I THINK THE BIGGEST PROBLEM IN LUNG CANCER, GENERAL [INDISCERNIBLE] OF THE LCT SPECIMENS FOR US TO ELECTRIC AT AND UNDERSTAND THE BALANCE. TO WRAP THIS UP A BIT [INDISCERNIBLE] SAID SHE WOULD LIKE TO HAVE US TAKE A VOTE ON ACCEPTING THE RECOMMENDATION TODAY, NOT THE REPORT BUT TO KIND OF GIVE YOU A FLAVOR OF THAT. PAULA DO YOU WANT TO EXPAND ON THAT OR NO? >> NOT REALLY. >> ALL RIGHT. PERFECT. I GET TEXTS FROM YOU, I WANT TO MAKE SURE I GOT THE RIGHT KIND OF NOTION THERE. >> OKAY, SO I WILL PUT THIS INTO CONTEXT FOR YOU. THE REPORT AS TO GO TO CONGRESS IN JUNE THIS COMMITTEE WILL NOT MEET AGAIN UNTIL JULY. SO FOR THE NCI TO IMPLEMENT ANY RECOMMENDATIONS, THOSE RECOMMENDATIONS MUST BE ACCEPTED IN AN OPEN SESSION OF THIS COMMITTEE. THIS COMMITTEE WILL NOT MEET UNTIL JUNE AND THE DRAFT IS DUE IN JULY, THE BEST THING TO DO IS TO ACCEPT THE RECOMMENDATIONS IN THE PRESENTATION PRESENTED TODAY AND THEN YOU CAN MOVE FORWARD TO FINALIZE YOUR REPORT. OKAY? >> AND TO CLARIFY THE REPORT WILL BE SENT TO CTAC AND WE WILL HAVE THE OPPORTUNITY TO VOTE ON THE FINAL REPORT SOMETIMES IN MAY OR JUNE. >> YES. AND THE RECOMMENDATIONS DISCUSSED TODAY I PRESUME WILL BE INCLUDED IN THE FINAL REPORT. CORRECT. >> ALL RIGHT. NOW THERE WAS SOME DISCUSSION AS WE TALKED, I THINK DEBBROUGHT IT UP ABOUT SOME AMENDMENTS AND THOUGHTS IN TERMS 1 MIGHT HAVE. >> THAT'S CORRECT. >> THERE ARE NO ISSUES WITH THAT. IF YOU HAVE SOMETHING SPECIFIC TO A COMMITTEE OR BOARD, IT'S PRESUMED TO BE FORMED AND AFTER THE MEETING WE CAN ALSO FINALIZE THOSE. >> OKAY. GREAT. SO I WILL ACCEPT A MOTION TO ACCEPT THE RECOMMENDATIONS THAT WERE PRESENTED TODAY EMPLOY. >> SECOND. >> MOVED. >> OKAY, ANY DISSENSIONS FROM THE GROUP? IF NOT THIS IS UNANIMOUS. THANK YOU SO MUCH FOR A TEROF YOUIC EFFORT ON THIS PART, THIS IS SUCH AN IMPORTANT DISEASE AND WE APPRECIATE WHAT YOU DONE AND WE LOOK FORWARD TO READING THE AREY PORT. OKAY, OUR LAST PRESENTATION--GO,A HEAD, IERM SORRY. ALEX OR NO. >> I SAID THANK YOU? >> ME TOO. >> YOU'RE WELCOME. YOU DID A GREAT JOB. SO THE LAST PRESENTATION WE WILL HAVE IS BY DR. LUBENSKY, FOR THE BIOSPECIMEN BANKS TO SUPPORT NCI TRIALS. THIS IS PREPARING FOR A RENEWAL OF A FUNDING ANNOUNCEMENT AND SHE IS LOOKING FOR INPUT FROM US PRIOR TO THE PRESENTATION TO THE BOARD OF SCIENTIFIC COUNSELORS WHICH WILL OCCUR IN JUNE. AND SHE WILL TALK ABOUT THIS, I THINK THERE IS A NUMBER OF DIFFERENT QUESTIONS THAT WILL BE ADDRESSED WHICH I THINK IS IN HER LAST SLIDE. SO I APPRECIATE YOUR INPUT. >> YES, THANK YOU SO MUCH AND I AM HERE TO PRESENT THE BIOSPECIMEN BANKING INITIATIVE THAT IS ADMINISTERED BY THE DIAGNOSIS PROGRAM DCCD. THE BIOSPECIMEN BANKS TO SUPPORT NCI CLINICAL TRIAL VS A GOAL OF PROCESSING, STORING AND DISTRIBUTING WELL UPDATED NCI CLINICAL TRIALS BIOSPECIMENS FOR CLINICAL TRIAL RESEARCHES AND FOR RESEARCHERS AT LARGE. THE CURRENT NCI SUPPORT IS AVAILABLE FOR NCI NATIONAL CLINICAL TRIAL NETWORK BANKS AND NCTN BANKS AND THE PILOT FOR THERAPEUTICS CLINICAL TRIALS NETWORK BANK, ETCTN BANK. HOWEVER OUR FUTURE PLANS STARTING FROM 2020 IS TO SUPPORT NOT ONLY INCREASINGLY SUPPORTING NCT BANKS BUT ALSO EXPANDING THE PROGRAM TO INCLUDE OTHER EARLIER CLINICAL TRIAL INTO THE EARLY CLINICAL TRIAL BANKS TO INCLUDE EARLY PEDIATRIC CLINICAL TRIAL NETWORK, SPECIMENS AND ALSO NCI COMMUNITY AND ONCOLOGY RESEARCH PROGRAM BANKING THAT IS ADMINISTERED BY DIVISION OF CANCER PREVENTION. SO TODAY I WOULD LIKE TO SOLICIT YOUR INPUT INTO THE PROGRAM WE HAVE NOW AS WELL AS THE FUTURE PLANS AS WE ARE PREPEARING TO GO TO BSC FOR REITERATIONS OF THIS PROGRAM. CURRENTLY 5 NCTN U24 COOPERATIVE GRANTS SUPPORT 5 NCTN BANKS THAT INCLUDE 4 ADULT BANKS AND 1 PEDIATRIC BANK RESPONDING IN NAMES OF COURSE TO NCTN GROUPS. THESE BANKS DON'T FUNCTION IN VACUUM, THEY ARE CONNECTED WITH OPERATING CENSUS AND CLINICAL TRIALS SITES OF THIS GROUPS. THE GRANT PIs IS A PATHOLOGIST IN BIOSPECIMEN BANKING AND THE GOVERNING BODY OF THIS COOPERATIVE AGREEMENT IS THE NCI BANKING STEERING GROUP THAT WAS STARTED IN 2006. IT HAS SEVERAL SUBSTEERING COMMITTEES LISTED HERE, THE REPRESENTATIVES FROM EACH OF THE 5 BANKS ALSO, THERE'S REPRESENTATION FROM CANADIAN, CLINICAL TRIAL GROUP AND NCI PROGRAM DIRECTORS FROM CTEP AND CDP THAT PARTICIPATE IN THIS COMMITTEE AND THESE ARE NOT JUST THE BANKERS BUT BROAD REPRESENTATION FROM STATISTICIANS, TRANSLATIONAL SCIENTISTS, REGULATORY PEOPLE, AND OTHERS SO ALTOGETHER WE ALWAYS WORK TO CREATE COMMON DOCUMENTS, STANDARD OPERATING PROCEDURES, CENTRAL MANUEL OPERATION TABLET SO THAT CAN BE IMPLEMENTED BY ALL THE BANKS. IT IS IMPORTANT TO KNOW THAT SPECIMENS ARE NOT COLLECTED BY THE BANKS THEMSELVES. THEY ARE COLLECTED BY TRIAL GROUPS FROM NCTN PHASE 2, PHASE 3 AND OTHER TRIALS ACCORDING TO THE TRIAL PROTOCOLS AND THE COLLECTION ITSELF IS SUPPORTED BY CTEP GROUNDS. SPECIMEN INITIALLY ARE USED BY TRIAL GROUP INVESTIGATORS FOR INTEGRAL AND INTEGRATED BIOMARKER STUDIES AND EENCH THE SPECIMENS REMAIN IN ACCESS AFTER THE CLINICAL TRIAL REQUIREMENTS HAVE BEEN COMPLETED, THEY BECOME LEGACY SPECIMENS AND ARE AVAILABLE FOR SECOND RELATIVE STUDIES FOR ALL INVESTIGATORS GROUP OR NONGROUP FOLLOWING THE NCTN BIOSPECIMEN ACCESS PROCESS AND APPROVAL BY NCTN AND THE SCIENCE COMMITTEE. IT IS IMPORTANT TO KNOW THAT THE SPECIMENS ARE BEST USED FOR VALIDATION STUDIES OF PREDETECTIVIVE AND PROGNOSTIC BIOMARKERS BASED ON TRIAL TREATMENT AND OUTCOMES AND FOR ASSAY DEVELOPMENT AND ACCOMMODATIONS. THESE SPECIMENS ARE NOTUTABLE FOR USING BASIC SCIENTIFIC EXPERIMENTS. --IN THE PERIOD OF 2015-17, THE BANKS DISTRIBUTED MORE THAN 440,000 SAMPLES. THE SPECIMENS WERE DISTRIBUTED TO 223 AND INVESTIGATE THIS FOR INTEGRATED MARKERS AND TO 348 RECEIVE SPECIMENS AND 128 OF THEM WERE NOT INVESTIGATORS THERE WERE MULTIPLE PUBLICATIONS THAT WERE RESULTED IN BIOSPECIMEN RESEARCH FOR RESEARCHERS WHO USED THIS BANK SPECIMENS, MANY OF THEM ARE IN HIGH PROFILE JOURNALISTS AND IMPACTED TRANSLATIONAL SCIENCE, CLINICAL SCIENCE AND EVEN WE'RE IMPLEMENTED CLINICAL PRACTICE. TO ILLUSTRATE THE VOLUME THAT THE BANK IS OPERATING ON, YOU CAN SEE HERE THEY HAD DISTRIBUTED 410,000 SOLID TUMOR SAMPLES AND ABOUT 30,000 LEUKEMIA SAMPLES DURING A PERIOD OF 2015-17 AND IN THE TABLES YOU SEE THE NUMBER OF SPECIMEN DISTRIBUTED BY WREER AS WELL AS BY SELECTED SAMPLE TYPE. CAN YOU SEE THAT MOST OF THE SPECIMENS ARE [INDISCERNIBLE] ARE FORMAL [INDISCERNIBLE] HOWEVER THERE'S INCREASED IN COLLECTION OF FROZEN DISTRIBUTION--DISTRIBUTION OF FROZEN SAMPLES WHICH IS INDICATIVE OF INCREASE OF OMICs TYPE RESEARCH FROM THEM LEUKEMIA, THE MOST COMMON SPECIMENS THAT BANKS DISTRIBUTE ARE BONE MARROW AND NUCLEIC ACIDS. AGAIN IT'S VERY IMPORTANT TO NOTICE THAT THE NUMBER OF SPECIMENS RELEASED FROM THESE BANKS DEPENDS ON THE NUMBER OF APPLICATIONS RECEIVE FRIDAY INVESTIGATORS AND THE BANKS DO NOT REGULATE THE NUMBER OF SPECIMENS THAT THEY RELEASE OTHERWISE. DURING THE SAME TIME PERIOD, THE BANK'S COLLECTED MORE THAN 1.6 MILLION SPECIMENS WHICH INCLUDE ALL INCOMING SAMPLES OF OF ALL OTHER ORGAN SITES, TYPES AND PREPARATIONS. AND AGAIN, THE COLLECTION OF THIS SPECIMEN IS TRIAL DEPENDENT NOT BANK DEPENDENT. THE SCIENTIFIC IMPACT OF THIS PROGRAM IS REFLECTED IN SELECTIVE PUBLICATIONS LISTED HERE; MANY OF THESE PUBLICATIONS EFFECTED TRANSLATIONAL RESEARCH, CLINICAL RESEARCH AND AGAIN WERE IMPLEMENTED INTO CLINICAL PRACTICE, LISTED HERE, LEUKEMIA, SPECIMENS THAT WERE PROVIDED TO LEUKEMIA RESEARCHERS AND ALSO SOLO TUMOR RESEARCHERS, 1 OF THE BEST EXAMPLES WE HAVE OF COURSE IS AN ONCA-TYPE [INDISCERNIBLE] THAT WAS SPECIMENS AND VALIDATED AND THE TAYLOR X CLINICAL TRIAL RUN BY ECOG, RELEASED ITS DATA AND NOW THE VALIDATION OF 21 GENE EXPRESSION THEY SAY ONCA-TYPE DX SIGNATURE IS AVAILABLE IN CLINICAL PRACTICE AND COULD DETECT THE NEED OR NOT NEED OF CHEMO THERAPY FOR EARLY BREAST CANCER COHORT. GUIDED BY DSA, THE NCI WAS TRYING TO IMPROVE THE ACCESS TO LEGACY BIOSPECIMENS AND AS A RESULT, THE NCDM NAVIGATOR WAS DEVELOPED. IT WAS DEVELOPED INITIALLY BY U24 BANKING GRANTEES WITH SUPPORT OF CDP AND CTEP, THE NAVIGATOR HAS BEEN LAUNCHED IN APRIL OF 2018 AND NOW IS COSTED BY CDSU, THE GOAL WAS TO CONSOLIDATE INVENTORY OF BIOSPECIMENS AND CLINICAL DATA AND PROVIDE BIOMESSENTERY MENS TO RESEARCH COMMUNITY AND TO TRACK THE APPLICATIONS FROM THE BEGENERATEDDING UP TO THE PUBLICATION ALSO WE DEVELOPED A FRONT DOOR SERVICE THAT COORDINATES AND GUIDES THE INVESTIGATORS IN THE ENTIRE WORK FLOW FOR THE INVESTIGATED ADOPTING SPECIMENS. HERE'S A PUBLISHED DATA AS I SNAPSHOT, STATUS OF THE NAVIGATOR TRIALS, SPECIMENS BY DISEASE CATEGORIES OF JANUARY 30, AS YOU CAN SEE, THIS ONLY THE PHASE 2 AND 3 TRIALS THAT ARE COMPLETED AND THEY ARE NOT ALL HERE YET BECAUSE THE BANK'S STILL UPLOADING THE INFORMATION. THERE'S NO PEDIATRIC BIOSPECIMENS HERE BUT WE'RE STARTING TO PUT THEM IN MARCH AND THE IDEA IS THAT ALL THIS TRIALS WILL BE AVAILABLE ON THE NAVIGATOR BETA BASE FOR RESEARCHERS TO LOOK AT WE ALSO HAD SECOND STAGE OF PLANNING NOT ONLY INCLUDE TRIALS FROM 1995 TO PRESENT AND ONLY PHASE 2 AND 3, BUT PUT HER SMALLER TRIALS, ALL TRIALS WHERE SPECIMENS ARE STILL GOOD AND ALSO THEY COULD BE AVAILABLE BY THE REVIEW BUT THAT EXPEDITED REVIEW. SO TO SUMMARIZE, THE LEGACY BIOSPECIMENS, FIRST OF ALL YOU DON'T HAVE TO BE THE INVESTIGATOR FROM THE GROUP THERE IS A WEB BASED NAVIGATOR THAT ALLOWS INDEPENDENT REQUIRE THE BANKS AND LOOK FOR SPECIMENS THAT MEET THEIR CRITERIA, AND THERE'S A FRONT OF SERVICE THAT GUIDES VRLGTS THROUGH THE ENTIRE PROCESS AND WE DO BELIEVE THAT THESE 2 EDITIONS WILL IMPROVE EFFICIENCY AND TRANSPARENCY OF THE BIOSPECIMENS PROCESS FOR THE ENTIRE CANCER RESEARCH COMMUNITY. RESPIRATORY THE RATIONAL TO KEEP SUPPORTING THESE BANKS IS RELATIVELY SIMPLE AT LEAST TO US. THESE ARE THE ONLY BANKS THAT SUPPORT NCI CLINICAL TRIALS COLLECTION OF SPECIMENS AND IF WE SUPPORT THEM FOR THE MCTM TRIAL SPECIMENS AND THE--THIS SPECIMENS ARE USED FOR WIDE RANGE OF VALIDATION STUDIES FOR THE BIOMARKERS, THEY'RE WELL UPDATE AND WELL UTILIZE AND RESULT IN HIGH IMPACT PUBLICATIONS. FURTHER MORE AS YOU ADD EARLY TRIAL SPECIMENS TO YOUR BANKS WE BELIEVE THIS WILL ALSO IMPROVE THE RESEARCH THAT THE USES THE SPECIMENS THAT ARE VERY IMPORTANT FOR INNOVATIVE CANCER THERAPIES. THIS PROGRAM HAD BEEN REVIEWED BY EXTERNAL REVIEW WITH THE CONSENSUS THAT THE RESOURCES OF HIGH VALUE THESE SPECIMENS ARE UNIQUE AND THEY PRAISE THE IMPORTANCE OF THE SERVICE AND THERE'S NO ALTERNATIVE TO THESE BANKS. THIS IS FUTURE PLANS FOR THE COOPERATIVE AGREEMENT WE ARE BRINGING TO BSA IN JUNE AND COVERS THE PERIOD OF 2026 AND IN THE LAST PAST SEVERAL YEARS NCI CLINICAL TRIALS ARE COLLECTING INCREASING NUMBER OF SPECIMENS REQUIRING COMPLEX EXENSEL PENSIVE PROCESSING FOR RESEARCH AND USE BY NOVEL TECHNOLOGY PLATFORMS AND IT IS IMPORTANT TO MAKE SURE THE BASE OPERATION OF THESE BANKS AND INFRASTRUCTURE WILL SUPPORT IT BUT IT'S ALSO IMPORTANT TO SUPPORT THE PREVIOUSLY UNFUNDED FUNCTIONS AND EXPANSION OF THE BANKS THE UNFUNDED FUNCTIONS ARE RS LISTED HERE AND THE NCTN BIOSPECIMEN NAVIGATE AND THE THIS NEEDS TO BE SUPPORTED THE APPROVED LEGACY SPECIMENS APPLICATION REQUIRE RETRIEVAL PROCESSING AND THE QAQC PATHOLOGIST WHICH IS TIME CONSUMING AND COSTLY. ALSO THERE IS AN EXPLOSION OF IMMUNOTHERAPY TRIES WHERE THE BANKS ARE ASKED TO PROCESS SPECIMENS AND SEND THEM TO CMACK LABS WHICH I CAN'T SAY IMMUNE MONITORING AND ANALYSIS CENTERS, LABORATORIES. THESE REQUIRE MORE EXPENSIVE OPERATION AS WELL AS VERY FRESH TISSUE. ALSO BECAUSE THE RESEARCH NOWADAYS MODERNIZED IN PLATFORMS THE SPECIALIZED HEATS AND TUBES FOR PROCESSING ARE REQUIRED, THE BANKS USUALLY MAKE THESE KIDS AND MORE OFFENSE WE'RE REQUIRING CTDNA COLLECTION IN [INDISCERNIBLE] TUBES SO WE'RE COUNTING FOR THIS UNFUNDED MANDATES IN THE FUTURE. AND ALSO WELL IS INCREASED USE OF DIGITAL PLATFORM FOR RENEWAL AND ARCHIVING OF BIOSPECIMEN THAT UNDERSCORES THE NEED FOR SCANNING AND STORAGE OF WHOLE SLIDE TISSUE IMAGES, THIS SEPARATION HAS NOT BEEN COVERED IN THIS BANKING THUS FAR BUT WE BELIEVE IT'S IMPORTANT TO COVER IT. , THE OTHER 3 EXPANSIONS THAT ARE SHOWN HERE ARE THE U AND WE WOULD LIKE TO USING THE PILOT PROJECT WE HAVE FOR EDCTN BANK TO EXPAND THIS BANK FOR OTHER EARLY CLINICAL TRIALS THAT WOULD INCLUDE CITN TRIALS ALSO THE SPECIMENS FROM EARLY TRIALS THAT WILL GO TO CMAC LABS. THE SITUATION HERE IS THAT THIS EARLY TRIAL SPECIMEN ARE VERY EXPENSIVE TO COLLECT AND THEY ARE QUIET MULTIPLE TIME POINT COLLECTION, SMALLER BIOPSIES, MORE UNIQUE PROCESSING, SOMETIMES IN REALTIME SO THAT NEEDS TO BE COVERED. ALSO THERE IS A NEED FOR COLLECTION OF AND IMPROVING RESEARCH IN PEDIATRIC CANCER AS PROVISIONED BY THE STAR ACT AND WE RECENTLY TALK TO PEDIATRIC EARLY FACE CLINICAL TRIAL NETWORK GROUP THAT NEVER COLLECTED SPECIMENS BEFORE THAT WE COULD SUPPORT BAIRVEGGING THROUGH THIS BANK THAT WE ALREADY HAVE AND LASTLY WE WOULD LIKE TO INCLUDE NCORP CANCER AND PREVENTION TRIALS BANKING INTO THE BANKS WE ALREADY HAVE INSTEAD OF CREATING NEW BANKS FOR THE DIVISION OF CANCER PREVENTION MCOR PROGRAM, WE WOULD LIKE TO FUND THEM THROUGH ALL 5 BANKS FOR BANKING OF MCORP SPECIMENS TO STREAMLINE OPERATIONS AND PROVEN ACCOUNTABILITY THROUGH THE COOPERATIVE AGREEMENT. SO WE WOULD LIKE TO HEAR YOUR INPUT AND I PREPARED SEVERAL QUESTIONS HERE TO START THE DISCUSSION BUT I WILL TURN TO DR. LAURIE TO CONDUCT I GUESS THIS DISCUSSION, RIGHT? AND WE'LL WELCOME ANY QUESTIONS. >> THANK YOU FOR THIS VERY THOUGHTFUL DISCUSSION. IT'S A LOT OF WORK THAT'S BEING DONE. SO THERE'S NOTE VOTE ON THIS, BY THE WAY SO OUR JOB AS A COMMITTEE REALLY IS MERELY TO PROVIDE INPUT AND ADVICE TO DR. LUBENSKY. SHE FRAMED THESE 4 QUESTIONS AND I THOUGHT WE MIGHT QUICKLY GO THROUGH THEM. WE HAVE ABOUT 15 MINUTES TO DISCUSS, 15-20 MINUTES TO DISCUSS ALL OF THIS PRESENTATION. WE WILL GO TO THESE QUESTIONS HERE BUT BEFORE WE DO, I WOULD LIKE TO OPEN IT UP BRIEFLY TO SEE IF THERE'S ANY CLARIFYING QUESTIONS FROM THE GROUP. >> HEY, THIS IS WALLY, THANKS FOR THE PRESENTATION. I HAVE 2 COMMENTS, NUMBER 1, THE NUMBER 1 COMMENT I'M GETTING FROM THE LEADERS OF THE BY O BANKS NOW--BIOBANKS NONAPOPTOTIC YOU IS --NEED FOR THE CLARITY FOR ROLES AND AFINANCIAL ACCOUNTABILITY BETWEEN THE GROUPS, CMAC AND THE BIOSPECIMEN BRAINKS AND THE CMAC HAS A NEW ENTITY, HOW WE HARMONIZE THEIR EFFORTS SO THAT WE GET THE MOST SCIENCE AND PRODUCTIVITY OUT OF OUR TRIALS IS A WORK IN PROGRESS AND I KNOW YOU DON'T HAVE FULL GOVERNANCE OVER THAT BUT IT'S--IT'S BEING PERCEIVED BY SOME OF OUR BIOBANKERS AS A TIME CONSUMING CHALLENGE TO FIGURE OUT HOW TO INTEGRATE THAT PROCESS IN. SO 1 OF THE THINGS AS WE SORT OF CONSIDER ROLLING OUT FUNDING FOR BIOBANKS IN A NEW CYCLE IS HOW CAN WE HARMONIZE THE CMAC INITIATIVE WITH A BIOSPECIMEN PEOPLE MORE EFFECTIVELY. WELL, I MEAN I KNOW OF THE DISCUSSIONS THAT ARE HAPPENING THROUGH THE GROUP BANKING COMMITTEES WHERE WE BROUGHT THEM CMAC PEOPLE FROM NCI TO TALK TO THEM IN OUR LAST MEETING AS WELL AS WE WERE CIRCULATING THE DOCUMENTS, THE UMBRELLA DOCUMENT FOR COLLECTION AND FOR BANKERS, SO WE'RE TRYING DEFINITELY TO HARMONIZE IT AND ON THE WAY TO DO SO BECAUSE OBVIOUSLY WE DON'T WANT EACH BANK DOING ANY DIFFERENT PROCEDURES. I DON'T KNOW HOW LONG AGO YOU TALK TO THEM. PRIORITY AMONG ALL OF US, GREAT, I THINK WE'RE A LONG WAY FROM A HARMONIZED SYSTEM IS MY OBSERVATION. >> YES, WITH THE BANKS ISSUES YES NLET'S GO TO THE QUESTIONS WE'LL TRY TO GET A FEW COMMENTS FOR EACH OF THEM AND AGAIN THIS IS TO HELP YOU WITH THIS FUNDING ANNOUNCEMENT THAT'S COMING OUT SO THE FIRST QUESTION IS THE RATIONAL OR JUSTIFICATION FOR SUSTAINED NCI FUNDING THAT COVER BANKING INFRASTRUCTURE AND THE PREVIOUSLY UNFUNDED PROCESS AND OPERATIONS IS THE RATIONAL ADEQUATE. SO COMMENTS FROM THE GROUP? >> THIS IS MIKE. I WANT TO JUST FIRST OFF FULLY SUPPORT THE EXTRA RESOURCES OR STANDARDIZATION RESOURCES WITH RESPECT TO THE NCOR PROGRAM SO I THINK THAT WOULD BE A GREAT ADDITION TO THE BANKING SYSTEM, SO THAT'S FULLY JUSTIFIED AND NEEDED. SO I HAD A QUESTION IN TERMS OF HOW MUCH ADDITIONAL--THE NUMBER OF SAMPLES CURRENTLY IS 300, 300 + THOUSAND BY THIS SLIDE SO BY ADDING THESE OTHER COMPONENTS, IRENA DO YOU HAVE ANY EXPECTATIONS HOW MUCH MORE THAT MEANS IN TERMS OF TOTAL SAMPLES. I KNOW THEY'RE DIFFERENT WITH WITH EARLY STUDIES BUT NCORP, BUT ANY SENSE OF HOW BIG A JUMP THAT WILL BE? >> WE ACTUALLY HAVE THE CALCULATIONS WE HAVE NEED TO REPAIR FOR SBL FOR EACH OF THEM FOR EDCTN AND ALL OTHER BANKS SO WE HAVE ESTIMATES OF NUMBER OF PASHTS THAT WE'RE GOING TO BE RECEIVING SPECIMENS FROM I CAN'T REALLY GIVE YOU THE EXACT NUMBERS BUT BUT WITH ASKING FOR SUPPORT AND INCREASE, A LOT OF THEM IT WASN'T PART OF THE OPERATION AS I SAID BEFORE BUT I DON'T HAVE THE EXACT NUMBER. >> OKAY, THANKS. >> CAN I FRAME THAT QUESTION A LITTLE BIT DIFFERENTLY? WHAT IS YOUR CAPACITY NOW TO EXPAND? OR DO YOU NEED A LARGER FORK FORCE TO HELP MEET THESE NEEDS? >> WELL, THE WORKFORCE REALLY DEPENDS ON FUNDING AND IT'S BEEN DIFFICULT TO ADEQUATELY TO FUND THIS TYPE OF OPERATIONS SO WE KIND OF CALCULATED ALL THE COSTS TRYING TO INCREASE THE FUNDING HERE BUT IT'S--IT'S ALWAYS BEEN A STRUGGLE BECAUSE THEY--THE BANKS CAN ONLY HIRE MORE PEOPLE IF THEY HAVE MONEY FOR EVERY PARTICULAR, YOU KNOW ITEM. AND THAT'S WHAT WE'RE TRYING TO ACHIEVE HERE, BUT I THINK IF THERE IS FUNDING, THERE IS A WAY TO INCREASE THE OPERATION OF COURSE. >> SO I GUESS TO THIS QUESTION THAT I'M TRYING TO GET TO AND HELP YOU OUT THERE IS THAT YOU'RE EXPANDING YOUR CAPACITY OR YOU'RE EXPANDING THE ACTIVITIES YOU HAD BEFORE WHICH IS LAUDABLE BUT DO HAVE YOU THE CAPACITY TO DO THAT? >> WE HAVE THE INFRASTRUCTURE TO DO IT, LIKE, WE NEED NOR REFRIGERATORS OR SOMETHING LIKE THAT OR MORE STORAGE SPACE THAT'S USUALLY NOT AN ISSUE, I THINK IT'S--IT'S REALLY THE COMPLEXITY OF NEW INITIATIVES THAT ARE COMING UP THAT BECOME AN ISSUE BUT BECAUSE THE BANKS ARE TRYING TO MAKE IT ALL STANDARD AND YOU KNOW THEY KIND OF HARMONIZE THE PROCEDURES, I MEAN BY HOPING TO COVER MOST OF IT BUT OF COURSE IT WILL NEVER BE COVERED IN FULL I DON'T KNOW IF THAT ANSWERS THE QUESTION. >> IT'S PROBABLY SOMETHING BEHIND THE DOORS OF YOUR-THERE THAT JIM CAN HELP WITH MORE. ANY OTHER COMMENTS ON THIS FIRST QUESTION? IF NOT WE WILL GO TO THE SECOND 1. WHAT ARE THE FUNCTIONS OF THE EARLY CTN TRIALS BANKS THAT ARE NEEDED TO FULFILL IN THE FUTURE--POTENTIAL THAT YOU ARE REQUIRE NCI INVESTMENT SO WE TALKED A LITTLE BIT ABOUT THIS. I THINK YOU CLARIFIED THAT. >> I WAS THINKING MORE THAT COULD YOU SUGGEST ANYMORE FUNCTIONS THAT THE BANK SHOULD BE DOING JUST BASED ON YOUR EXPERIENCE. >> WELL A COUPLE THINGS COME TO MIND AND I'M NAIVE ON THIS. HOW WELL--I KNOW THE TISSUES ARE ANNOTATED, ARE THEY ANNOTATE INDEED REALTIME? YOU KNOW TO OUR EARLY EARLY PRESENTATION, IF WE WANTED TO LOOK AT ALL THE YOUNG TERM SURVIVORS OF SMALL CELL LUNG CANCER THAT HAVE BEEN THROUGH OUR COOPERATIVE TRILS, CAN WE PUSH A BUTTON AND GET THOSE SAMPLES TO DO THE ANALYSIS ON THOSE AND THOSE KINDS OF THINGS WELL THEY ANNOTATE THE STATISTICAL CENTERS THAT HAVE THE DATA FOR CLINICAL ADAPTATIONS, THE BANKS HAVE THE BANKING ANNOTATION AND I THINK IT'S--MACK CAN TALK TO IT BUT MANY OF THEM ARE TOTALLY, YOU KNOW IN SYNCH RIGHT NOW, SPECIALLY WITH NAVIGATOR WE ONLY PUT THINGS THERE THAT ARE COMPLETELY ANNOTATED. I DON'T KNOW IF THERE'S MORE NEED FOR DOING MORE WORK ON THAT. >> SO SORRY, YEAH, THE WHOLE EMPHASIS WHEN WE INITIATED NAVIGATOR WAS TO MAKE SURE WE COULD BE AS IN INSYNCH AS POSSIBLE FOR THE BANKERS AND THE SPECIMENSAs WELL AS CLINICAL TRIALS GROUPS AND THEIR STATISTICAL CENTERS. SO THAT WHEN SOMETHING DOES GO INTO NAVIGATOR, THAT'S AVAILABLE FOR THE COMMUNITY THAT THEY CAN RUN APPROPRIATE SEARCHES AND THEN USE THE FRONT DOOR SERVICE TO MAKE SURE THAT FOR THEIR PROPOSED RESEARCH PROPOSAL, THAT WE DO HAVE THE SPECIMENS THAT THEY'RE LOOKING FOR, NOW THERE ARE SOME ISSUES THAT WE HAVE TO WORK OUT WITH THAT, BUT WE'RE MOVING MUCH MORE TOWARD THAT DIRECTION TO MAKE SURE THAT'S IN PLACE. OBVIOUSLY FOR THE ONGOING TRIALS WHETHER THERE'S AN INTEGGIC--STRATEGIC RAERAL OR INTEGRATED ONGOING TRIAL, THAT'S ALL IN REALTIME AS WELL, BUT WE'RE TRYING TO PROVIDE THAT TYPE OF SERVICE FOR THE COLLECTED SPECIMENS THAT BECOME AVAILABLE AFTER THE TRIAL HAS BEEN COMPLETED AND THE RESULTS HAVE BEEN PUBLISHED THROUGH THE EPITIRE NAVIGATOR PROCESS. I CAN ADD TO WHAT MEG SAID, I DON'T THINK WE'RE UNIQUE TO THESE SYSTEMS AND DATA MANAGEMENT CENTERS BUT NOW WITH THE BANK THAT'S ASSOCIATED WITH SWAB, WE HAVE CONTINUOUS UPDATES WITH RESPECT TO THE BANKING INVENTORY SO EVEN THOUGH THOSE MAY NOT BE AVAILABLE IN NAVIGATOR BECAUSE WE HAVE THOSE LINKAGES IN YOUR DATABASE WE CAN COME UP WITH OUTCOME DATA ASSOCIATED WITH THE STUDIES AS MEG SAYS, WHEN THE STUDIES ARE DONE BUT WE'RE TALKING ABOUT LEGACY STUDIES HERE TYPICALLY, SO THOSE LINKAGES ARE FAR BETTER THAN THEY WERE BEFORE AND SO WE DO HAVE THOSE IN REALTIME. SO THOSE ARE HELPFUL. >> OTHER FUNCTIONS FOR THIS QUESTION THAT YOU THINK ARE WORTH WHILE FOR NCI? DAVID? >> YEAH, SO, AND THIS MAY BE JUMPING THE GUN A BIT, THE NEXT QUESTION MAY BE OUTSIDE OF THE SCOPE, BUT I WAS WONDERING HOW TO WHAT EXTENT WILL ADJUDICATE HOW THESE SAMPLES ARE USED. I'M FAMILIAR WITH THE NCTN PROCESS BECAUSE I'M ON THE STEERING COMMITTEE BY CTEP, AND WE HAVE A MEETING THIS AFTERNOON, AND AS WE COAALATE THESE TOGETHER IN A COMMON BANK WHICH HAS A LOT OF APPEAL IS THERE GOING TO CONTINUE TO BE A COAALATED REVIEW PROCESS FOR ACCESS TO THE SPECIMENS, AND WILL THAT BE--WILL THAT BE ADJUSTED BEYOND WHAT WE'RE NOW DOING FOR THE NCTN CORRELATIVE SCIENCES COMMITTEE. >> MEG WAS GOING TO ANSWER THAT. >> YEAH, WE HAVE YES, ALL THESE RESEARCH PROTOCOLS GO THROUGH THE NCTN CORE AND WE WOULD ADD NCOR TO THAT WHEN THAT BECOMES AVAILABLE, THE COR CORRELATIVE SCIENCE COMMITTEE AND THAT'S IN PLACE, AND THAT'S A COMMITTEE AFTER WHAT'S BEEN DONE FOR THE NCI DISEASE-SPECIFIC AND OTHER SCIENTIFIC-SPECIFIC STEERING COMMITTEES WHERE WE HAVE MEMBERS FROM THE EXTRA MURAL COMMUNITY THAT ROTATE IN PERIODIC TERMS. SO THAT IS ALL IN PLACE RIGHT NOW FOR ALL THE PROPOSALS THAT COME IN FOR ACCESS THROUGH A NAVIGATOR. >> YEAH, AND THE ONLY THING I MIGHT COMMENT MEG IS YOU KNOW THIS BETTER THAN I DO, THAT WE JUST EXPAND THAT TO 2 COMMITTEES SO IT'S WORTH THINKING ABOUT, YOU KNOW CONTINUING TO MAKE THAT REVIEW PROCESS EFFICIENT, MAYBE PRIMATESSAGING THE LOCAL LEVEL OF REQUESTS AS YOU CORRELATE THE TISSUE BANK WHICH WOULD BE VERY VALUABLE TO SCIENTISTS ACROSS THE COUNTRY. >> YEAH AND THAT'S SOMETHING WE'RE WORKING WITH THE BANKERS AND ON AND THE INVESTIGATORS AND IDENTIFY WHEN WE DO THAT AND AS YOU SAID WE JUST EXPANDED TO DO 2 COMMITTEES THAT WILL ALSO HELP US OVERSEE THE INTRODUCTION OF THE PEDIATRIC CLINICAL TRIALS INTO NAVIGATOR AS WELL. BUT ABSOLUTELY WE ARE TRYING TO LOOK AT HOW WE CAN TRIAGE THINGS AND MAKE AVAILABLE IN THOSE MODIFIED PROPOSALS AND THOSE TYPES OF APPROACHES. >> GREAT. THANK YOU. >> THE OTHER QUESTION I WAS GOING TO ASK ABOUT THE TCGA APPROACH IN WHICH THERE'S BEEN TREMENDOUS DAILY BASIS THEA WITH THE GENOMIC DATA AND ALL OTHER THAT'S THERE BUT IT'S NOT OPEN TO THE PUBLIC SO EACH OF THESE TRIALS THAT ARE DONE, EACH OF THESE STUDIES IS THERE A WAY TO INTEGRATE THE RESULTS FOR THESE PEASHTS SO WITH A SAMPLE THEY HAVE THE ABILITY TO ACTUALLY NOT JUST PURVIEW SMALL CELL LUNG CANCER, COLON CANCER BUT GO TO PATIENTS WHO HAVE CERTAIN MUTATIONS ACROSS DISEASES. CRAZY IDEA? >> NO. [LAUGHTER] SO WE DO MAKE AND MAYBE MIKE CAN SPEAK TO THIS, WE ARE NOW MAKING PATIENT LEVEL TO DEIDENTIFY DATA PHASE 3 TRIALS THROUGH A DATA ARCHIVE. AND ANY KIND OF PROJECT IS DONE WITH THE BIOSPECIMENS COLLECTED THROUGH THE NCTN AND OTHER ECTN AND THE OTHER TRIALS GROUPS AND THERE'S A PROPOSAL FOR THAT DATA SHARE SUGGEST IN PLACE, SO IF GENOMIC DATA IS DONE, THEN OUR HOPE GOES INTO SOME DATA COMMONS TYPE OF DATABASE AND THAT WE CAN POTENTIALLY SET THIS UP SO WE CAN HAVE CONNECTIONS THAT ARE MORE EASILY MADE BETWEEN GENOMIC DATA THAT MIGHT BE DEMOSITTED IN 1 DATABASE AND THE CLINICAL TRIAL DATA THAT'S AVAILABLE IN OUR DATA ARCHIVE FOR AT LEAST FOR STARTING WITH THE PHASE 3 TRIALS AND SELECTED PHASE 3 TRIALS, I THINK WE HAVE A LONG WAY TO GO SO THAT WE HAVE THAT IN A SEAMLESS WAY BUT THATIA I GOAL FOR US TO TRY TO MAKE CONNECTIONS BETWEEN THOSE DATABASES. >> ANY OTHER COMMENTS ON THIS QUESTION? LET'S DROP DOWN TO THE OTHER 1-- >> SORRY. >> THIS IS MIKE I WAS ADD TOKING WHAT MEG SAID, YES, SO NOW WE HAVE--IF A STUDY'S PUBLISHED OUT IN ADDITIO TO THE GENOMIC DATABASES, IF THE STUDY IS PUBLISHED OUT WITH THE CLINICAL DATA THAT PATIENT LEVEL DATA WILL BECOME AVAILABLE AS PART OF THE IN, CTN DATA SHARING ARCHIVE AS WELL SO IT COULD BE ALREADY LINKED UP AS PART OF THAT PHASE 3 STUDY SECONDARY ANALYSIS. SO THIS PROCESS MAKES IT ALREADY IN PLACE, AND SO WITHIN 6 MONTHS OF PUBLICATION OF THATTA PAPER, THAT DATA WILL BE IN THE NCTN DATA SHARING ARCHIVE. >> TEROFIC. TERRIFIC. OKAY. THIRD QUESTION, WILL THE CURRENT FUTURE STRATEGIES FOR IMPROVED BIOSPECIMEN ACCESS THROUGH THE NCTN BIOSPECIMEN NAVIGATOR HELP RESEARCHERS AND INCREASE UTILIZE OF THE NCTN LEGACY SPECIMENS? ANYBODY WANT TO COMMENT OR ASK QUESTIONS. >> DOESN'T SOUND LIKE IT. >> I THINK THE ANSWER IS YES, I THINK? >> YEAH, YOU KNOW WHAT, THE 1 QUESTION I WOULD RAISE RELATED TO NAVIGATOR IS AGAIN NO 1'S HAPPY WHEN THE NAVIGATOR TURNS DOWN THEIR PROPOSAL AWE WE REALLY SHOULD BE REVIEWING THE PROCESS ON A REGULAR BASIS. THE PROCESS IN TERMS OF ARE WE STREAMLINING THE APPLICATION PROCESS? IS IT THE APPROPRIATE LEVEL OF DETAIL AND THE APPROPRIATE LEVEL OF SCRUTINY. YOU KNOW WE WANT THESE SPECIMENS AVAILABLE AND OUT THERE AND IS THIS TOO MUCH OF A GOVERNOR ON THIS PROCESS AND I'M NOT SURE ANY OF US KNOW THE ANSWER BUT WHEN WE INTRODUCE A NEW SYSTEM, LOOKING ASTERISKS IT AND GROUP CHAIRS OR WHOEVER ON A REGULAR BASIS I THINK IS CRITICAL. >> OBVIOUSLY, WE ARE MORE THAN HAPPY TO COMPLY WITH THAT, AND WE JUST NEED TO GET A LITTLE EXPERIENCE WITH IT. AS I THINK DR. MANKOFF ALREADY SAID WE'RE TRYING TO REVIEW THE CRITERIA THAT WE USE, I DO WANT TO MAKE THE DISTINCTION, NOTES AUTONAVIGATOR THAT'S TURNING DOWN THE PROPOSAL-- >> I GET IT. >> YEAH? BUT WITH THE CORE CORRELATIVE SCIENCE COMMITTEE IN PARTICULAR, YOU KNOW WALLY, OBVIOUS 3 THERE ARE REPRESENTATIVES FROM ALL THE GROUPS ON THAT AND WE'RE TRYING TO DEAL WITH THOSE THINGS AND WORKING WITH THE BANKERS AND TRIALS AND LEGACY SAMPLES MEET CERTAIN CRITERIA, CAN WE FREE UP THE EVALUATION PROCESS AND THAT'S EXACTLY THE TYPE OF THING WE WANT TO DO BUT NAVIGATOR IS PRETTY NEW SINCE WE JUST STARTED IT LAST APRIL AND AS THEY SAY, THE BIG PUSH IS TO GET EVERYTHING IN AND CONTINUE THAT, BUT THAT IS ABSOLUTELY A GOAL FOR ALL OF US, I THINK? >> YEAH, AND YOU'RE RIGHT. MEG I'M TALKING ABOUT THE REVIEW PROCESS. BECAUSE YOU CAN IMAGINE THAT'S A NUMBER 1 GRIPE I HEAR FROM PEOPLE. AND AGAIN IF WE'RE MAKING IT MORE RIGOROUS BECAUSE IT'S OF VALUE, THAT'S UNDERSTOOD. >> I'LL CHIME IN, BUT IT'S REALLY NICELY DONE, THE REVIEW BUT AS WE EXPAND THE NUMBER OF SAMPLES INVOLVED, I THINK OF WHAT WALLY IS TALKING ABOUT IS LOOKING AT THE PROCESS FROM START TO FINISH SO THAT THE LEVEL OF REVIEW AND EXPEDITING MATCHES IS WHAT INVESTIGATORS ARE ASKING FOR SO THAT'S A GREAT IDEA AND I DO WANT TO SUPPORT ON THAT EXITEE HOW HARD CTEP IS WORKING TO MAKE THAT HAPPEN. >> THANK YOU. THANK YOU. >> LET'S MOVER ON TO THE LAST QUESTION THEN WE HAVE ALL THESE SAMPLES, HUNDREDS OF THOUSANDS OF SAMPLES BUT OHM ABOUT 5 OR 6 HELPED PEOPLE USING THEM WHAT ARE THE BEST WAYS TO INCREASE THE AWARENESS OF THE BIOSPECIMEN BANKS, RESOURCE, RESEARCH COMMUNITY BEYOND THE STRATEGY OF THE PROGRAM THAT WE'RE DOING? AND I THINK THIS GETS TO THE RFA YOU'RE PLANNING SO THOUGHTS ON HOW TO EXPAND THE AWARENESS? >> WELL I CAN TELL YOU WHAT THE PROGRAM IS DOING CURRENTLY. WE HAVE THE NAVIGATOR AND THE BANKS LISTED ON THE IN, CI WEB SITE, CTE, CDP WEBSITES AND ALSO PUT IT INTO THE NCI RESEARCHER'S WEBSITE AND OF COURSE, AS YOU KNOW, ANY WEBSITE IS ONLY GOOD IT SOMEBODY FINDS IT. IT'S VERY DIFFICULT TO HARM OPEN MEETINGIZE THAT, WE ALSO PRESENTING MEETING EXHIBITS AND FLYERS AND OF COURSE WE USED TO DO NCI E-MAIL PUSH TO SYRUP GRANTEE BUT WE DON'T HAVE THE FULL LIST OF PEOPLE WHO WOULD USE THIS SPECIMEN AND YOU KNOW THEY ARE USING [INDISCERNIBLE] BUT EVERYBODY USES IT AND MORE IMPORTANTLY, SPECIAL RESOURCE LIKELY THAT WE MANAGE FOR THE IN, CI, AND CDP WHICH LISTS NUMEROUS RESOURCES THAT ARE AVAILABLE FOR RESEARCHERS BUT AGAIN, THE WEBSITE IS AVAILABLE, THE URL IS AVAILABLE BUT NOT EVERYBODY KNOWS ABOUT IT SO WHAT ARE THE BEST WAYS TO INCREASE AWARENESS OF THIS RESOURCE STILL STANDS. >> SO THIS IS DEB, 1 OF THE TECHNOLOGY TRANSFERS I'VE SEEN USED THAT SEEMS TO BE PRETTY EFFECTIVE IS THAT EVERYBODY, YOU COULD--THERE COULD BE A SLIDE DEVELOPED THAT IS SHARED AND EVERYBODY WHO ACTUALLY USES THE RESOURCE, NUMBER 1 WHETHER THEY'RE DOING THEIR SCIENTIFIC PRESENTATIONS TO INCLUDE THAT SLIDE, INFORMATION SLIDE OF, THIS IS WHERE THE SAMPLES CAME FROM, THIS IS HOW YOU TOO CAN HAVE ACCESS OR WHATEVER, IN SCIENTIFIC PRESENTATIONS BECAUSE THOSE ARE LIKELY THE AUDIENCES THAT WOULD WANT TO USE THE SAMPLES IN THE FAVORITE PLACE. BUT I DO THINK IN SCIENTIFIC MEETINGS THIS IS PROBABLY THE BEST WAY WHETHER THERE BE ADDITIONALLY BROCHURES OR LITTLE POST CARDS OR SOMETHING TO GET THE URL OUT THERE. SMSH HAS THE IN, CI EVER CONSIDERED MAKING A REQUIREMENT OF GETTING A GRANT SIMPLY RECORDING YOUR BIOSPECIMEN COLLECTION TO THAT NCI SPECIMEN RESOURCE LOCATOR WEBSITE. IT'S KIND OF LIKE THE RAISE YOUR HAND POLICY, IT DOESN'T MEAN YOU HAVE TO SHARE THE SAMPLES. IT JUST MEANS STATE WHAT YOU HAVE ON THAT WEBSITE SO THAT EVERYBODY CAN KNOW WHO TO GO TO TO ASK TO SEE IF A MIGHT BE ABLE TO ACCESS THAT COLLECTION. IN BRAIN TUMORS VERY FEW COLLECTIONS ARE REPORTED TO THAT BUT EVERYBODY WANTS TO KNOW WHERE THE COLLECTION SAMPLES ARE SO WE'RE ALWAYS RUNNING AROUND AND SEEING WHO HAS WHAT. >> IT'S AN INTERESTING QUESTION BECAUSE SO FAR THE SUBMISSION STATES WHETHER [INDISCERNIBLE] NCI USUALLY DOESN'T REQUIRE AND IN FACT, THIS WEBSITE IS JUST HAS A LIST OF RESOURCES FOR URLs, SO IT'S A VERY LIKE TELEPHONE BOOK UP WEBSITE BUT IT'S VERY HELPFUL AND I DON'T KNOW IF THERE'S ANY WAY TO REQUEST SOMETHING COMPULSORY LIKE THAT. DO YOU HAVE ANY IDEAS HERE? >> I THINK IT BEARS--THIS IS JIM DOROSHOW, I THINK IT BEARS FURTHER CONSIDERATION. WE DO REQUIREMENT FOR EXAMPLE THAT INDIVIDUALS WHO GET SOME OF THOSE PUT THOSE RESOURCES IN THEIR ACKNOWLEDGMENTS OF THEIR PAPER PARS SO YOU NEED TO REALISTICALLY LIST WHO YOU'RE PAYING FOR REPOSITORIES FOR THE REQUIREMENT. WE NEED TO LOOK AT IT. DRAIF EDUCATIONAL IT'S AN IDEA WORTH CONSIDERING. >> BY THE WAY ALL THE NCTN BANKS ON ARE ON THAT WEBSITE CURRENTLY, SPECIMENS LOCATED BUT THERE COULD BE MORE. >> OKAY, IF NO OTHER COMMENTS, I THINK WE GAVE YOU FOOD FOR THOUGHT SO HOPEFULLY WE HELPED HERE A BIT. >> YES THANK YOU VERY MUCH. REALLY APPRECIATE IT. >> SO CLICK AND CLAK, WE MADE IT THROUGH A COUPLE HOURS HERE BUT A ROBUST GOOD MEETING AND GOOD DISCUSSIONS. YOU KNOW THIS MEETING WAS BASICALLY TO GIVE UPDATES ON THE WORKING GROUPS. WE WILL HAVE OUR NEXT MEETING AS I MENTIONED EARLIER ON JULY 17 WHICH WILL BE A FACE-TO-FACE MEETING. THERE WILL BE A--WE PLAN AT THAT TIME TO HAVE AT LEAST THE DPLI O BLASTOMA WORKING GROUP WILL HAVE HELD A MEETING, HELD A MEETING IN JANUARY AND WE'LL HAVE I--WE EXPECT AN UPDATE FROM THAT GROUP AT THAT MEETING FACE-TO-FACE. THE RADIATION ONCOLOGY GROUP AS MENTIONED BY DR. SHARPLESS, HAS BEEN NAMED AND WE PROBABLY WON'T HAVE A REPORT AT THIS TIME. ON MARCH 14th, MARCH 14th THE CTAC PLANNING GROUP WILL GET TOGETHER TO DISCUSS FUTURE MEETING TOPICS AND IF YOU WOULD LIKE TO PARTICIPATE, IF YOU COULD LET DR. BRENDA KNOW ABOUT THIS, WE WILL GET YOU ON THE LINE. I THINK WHAT WE REALLY WANT TO DO WITH THESE PLANNING GROUP SYSTEM TO MAKE SURE THAT WE PROVIDE THE RIGHT FRAMEWORK TO HELP THE NCI AND THE IN, CI DIRECTOR IN TERMS OF THE-OF GIVING US ADVICE AND I THINK WE--I WANT US TO BE AS INTERACTIVE AS WE CAN IN TERMS OF HELPING THEM SO WE WILL HAVE THIS CALL ON MARCH 14th. ANY OF YOU WHO WERE ON THE CALL, DELIGHTED TO HAVE YOU THERE, JUST LET SHEILA KNOW OF YOUR INTEREST ON THAT. IS THERE ANY OTHER BUSINESS OR TOPICS YOU WANT TO BRING UP BEFORE WE CLOSE? SUDDEN DEATHLY YOUR FACES GO THE REALLY BIG. IT'S NICE TO SEE YOU ALL. I WANT TO THANK ALL OF YOU ATTENDING AND WE WILL GET YOU OUT OF HERE EARLY AND TAKE CARE AND HAVE A GOOD SPRING.