I WOULD LIKE TO WELCOME THE MEMBERS OF THE NATIONAL CANCER ADVISORY BOARD, WELCOME, EVERYONE. STAFF AND GUESTS. I'M GOING TO NOW READ REQUIRED ANNOUNCEMENTS. MEMBERS OF PUBLIC WHO MAY WISH TO EGG EXPRESS VIEWS ITEMS DOES CUSSED IN THE MEETING MAY WRITE PAULETTE GRAY, EXECUTIVE SECRETARY OF THE BOARD WITHIN TEN DAYS AFTER THE MEETING. ANY WRITTEN STATEMENTS BY MEMBERS OF PUBLIC WILL RECEIVE CAREFUL CONSIDERATION. AS BOARD MEMBERS INTO PREMIND YOU YOU MUST ABSENT YOURSELF DURING SPECIFIC DISCUSSIONS WHENEVER YOUR PARTICIPATION DELIBERATIONS ON A PARTICULAR PRODUCT, PROGRAM OR OTHER SPECIFIC MATTER WOULD CONSTITUTE A CONFLICT OF INTEREST OR CREATE THE APPEARANCE OF ONE. IT IS ENCOUPLE BENT UPON YOU THE ADVISE THE EXECUTIVE SECRETARY AND ABSTAIN FROM PARTICIPATION AND DISCUSSION OR ACTION REGARDING THAT MATTER. IN LIGHT OF THE CURRENT POLICIES GOVERNING CONFLICT OF INTEREST, BASED ON FINANCIAL HOLDINGS, OF SPECIAL GOVERNMENT EMPLOYEES, WHICH INCLUDES ALL MEMBERS OF THE BOARD, WE MUST DEPEN ON YOU TO VOLUNTARILY ABSENT YOURSELF DURING ANY AND ALL DISCUSSIONS OF MATTERS THAT COULD CONCEIVABLY IMPACT THE STATUS OF THOSE HOLDINGS. WE TRUST YOUR JUDGMENT IN THESE INSTANCES. DURING ANY CLOSED SESSION ANY MATERIALS OR DISCUSSIONS OF A CONFIDENTIAL NATURE DELIBERATED ON TODAY ARE PRIVILEGED INFORMATION AND MADE AVAILABLE TO YOU ON A NEED TO KNOW BASIS. SUCH DELIBERATIONS ARE PRIVATE AND CONTENT SHOULDN'T BE DIVULGED. A FUTURE MEETINGS, ARE IN THE FOLDER, AND ON THE AGENDA, THOSE NOT HERE SHOULD HAVE THE AGENDA HAVING BEEN MAILED TO YOU. I WOULD LIKE TO APRO-THE JUNE 2018 JOINT BSA NCAB SUMMARY OF MINUTES. CAN I GET A VOTE OF YEA. >> YEA. >> SHOW OF HANDS. ANY NEES? ANY ABSTENTIONS? OKAY. THOSE MINUTES ARE NOW APPROVED. I WANT TO REMIND EVERYONE ABOUT CELL PHONES AND OTHER SIMILAR DEVICES. ALL CELL PHONES SHOULD BE TURNED OFF OR SET ON VIBRATE. WHENEVER THESE INSTRUMENTS GO OFF THEY ARE DISRUPTIVE. THIS APPLIES TO STAFF MEMBERS AND OTHERS IN THE ROOM. WE NEED A QUORUM BY LAW OF BOARD MEMBER FOR EACH INSTANCE WHICH A VOTE MAY OCCUR, WHETHER IN OPEN OR CLOSED SESSION DURING THIS MEETING A MINIMUM OF NINE APPOINTED MEMBERS MUST BE PRESENT TO VOICE VOTES. SINCE WE CAN'T PREDICT TIME OR OCCURRENCE OF ANY MOTION YOUR PRESENCE IS FOR ALL SEGMENTS OF MEETING IS A MUST. I'LL BEGIN TODAY'S AGENDA AND TURN TO NED WHO WILL GIVE THE NCI DIRECTOR'S REPORT. >> NEVER MIND. I THINK I GOT IT. LET ME SEE. I THINK I UNMUTED IT. >> THANK YOU. OKAY. SO GOOD AFTERNOON. THANK YOU ALL FOR BEING AVAILABLE TODAY TO (INDISCERNIBLE) AT BRIEF UPDATE -- CAN YOU MUTE PLEASE. A BRIEF UPDATE ON BUSINESS BEFORE THE NCI IN A FEW AREAS AND TIME THE TAKE FOR QUESTIONS AFTERWARD. SO THE STRUCTURE OF TODAY'S TALK WILL LOOK LIKE THIS. I WAS GOING TO SAY WORDS ABOUT THE BUDGET. I THOUGHT BECAUSE OF THE SHORTENED COMPRESSED SCHEDULE I WOULD DO THE LEGISLATIVE UPDATE AND MK WILL CORRECT ME IF I GET SOMETHING WRONG. A FEW ANNOUNCEMENTS ABOUT THE CANCER MOON SHOT, EXCITING INITIATIVES TO TALK ABOUT, BRIEFLY MENTION THE R 50 AWARD, THE RT PIN AND ALSO THE RESPONSE STUDY. BUT I'M SURE THERE ARE OTHER ISSUES THAT NCAB MEMBERS WILL TALK ABOUT TODAY WE'LL TALK ABOUT THAT AS WELL. SO FIRST THE BUDGET WE ARE NEARING THE END OF FISCAL YEAR 18. IT IS A BUSY TIME, THE SUMMERTIME FOR THE NCI STAFF. AND ALSO TO THINK ABOUT >> PLEASE EVERYONE MUTE YOUR PHONES. THANK YOU. >> THANK YOU. SO APPLYING FOR 2019 AS WELL. SO THOSE WHO FOLLOW THE NEWS THIS SHOWS THIS IS THE SLIDE SHOWING THE LAST FEW YEARS -- FISCAL YEARS 15 TO 18 SHOW AS NICE INCREASE SUPPORT FOR THE NATIONAL CANCER INSTITUTE FROM CONGRESS. THE ORANGE INDICATES MOON SHOT FUNDING WHICH HAS BEEN FULLY FUNDED LAST -- IN 2017, 2018. THEN TO THE RIGHT ON THE -- OF THE ORANGE LINE SHOWS THE PRESIDENT'S FY 19 BUDGET AS WELL AS HOUSE AND SENATE BILLS, THAT ARE BEING RECONCILED PRESENTLY. BOTH PROVIDE FULL FUNDING FOR THE MOON SHOT WHICH MEANS $400 MILLION OF FUNDING FOR THE NCI IN 2019 AS WELL AS INCREASE TO BASE APPROPRIATION BRINGING THE NCI BUDGET FOR FIRST TIME OVER $6 BILLION IF APPROVED SO THIS CONTINUES TO SHOW BROAD BIPARTSON SUPPORT FOR THE NCI AND I THINK WOULD BE AT YEAR OF STABLE PREDICTABLE FUNDING WHICH IS WHAT THE NIH IS FOR T REALLY HELPED BY THE STABLE PREDICTABLE SUPPORT. REMINDING YOU WE ARE HERE NOW FINISHING WITH 2018. THIS IS I SAID A LOT OF WORK FOR OFFICE OF BUDGET FINANCE AND OTHER PARTS F THE NCI TO MAKE SURE WE GET ALL CONTRACTS AND GRANTS FUND IN A TIMELY WAY. AND THEY'RE TO BE CONGRATULATED ON A TERRIFIC JOB OF HANDLING EXTRA FUNDING THAT APPEARED LATE IN THE BUDGET THIS YEAR AND MAKING REALLY GOOD PROCESS. SO I WANT TO REMIND EVERYONE ABOUT THE GOOD PROBLEM THAT IS PROVIDED BY CANCER MOON SHOT FUNDING AND THAT'S SHOWN HERE. AS NOTED 17 AND 18 PROVIDE $300 MILLION OF -- PROVIDED 300 MILLION-DOLLAR OF FUNDING FOR THE NCI, 19 IS EXPECTED TO PROVIDE 400 MILLION-DOLLAR OF FUNDING. THEN IT'S FOLLOWED BY TWO IN A WAY 200 MILLON-DOLLAR CUTS IF YOU WILL SO 2019 TO 2020, THE BUDGET GOES FROM 400 TO 200 AND 2023 OFF DOWN ANOTHER $2 MILLION SO PLANNING RELATED TO THESE PEAKS AND VALLEY ALSO OF THE MOON SHOT ARE CHALLENGING THIS TASK IS MADE SOMEWHAT EASIER BY THE FACT THAT THIS FUNDING IS NOT BOUND BY FISCAL YEAR SO ANY YEAR MONEY WHICH PROVIDES ADVANTAGES BUT ADDITIONALLY GOALS OF THE MOON SHOT WE'RE TRYING TO USE THE MONEY AS EXPEDITIOUSLY AS POSSIBLE TO ACCELERATE PRE-CLINICAL DEVELOPMENT -- TRANSLATION OF EMERGING THERAPIES. AND OTHER ANTI-CANCER MATTERS SO THAT MEANS I DRESSING -- THE GOOD NEWS IS UNEXPECTED $100 MILLION INCREASE NEXT YEAR BUT THE PROBLEM IS DECREASED FUNDENING 2020 AND 2024. SO HOW TO HANDLE THAT IN OUTYEARS IS SOMETHING WE SPEND TIME TALKING ABOUT AND HAPPY TO ELABORATE IF THERE'S FURTHER INTEREST. BRIEFLY GIVE A LEGISLATIVE UPDATE. THERE'S BEEN A LOT OF ACTIVITY IN THIS SUMMER IN THE LEGISLATIVE SECTOR. WE HAVE HAD HOUSE AND SENATE APPROPRIATION COMMITTEES PASSED 2019 BUDGETS WITH INCREASES FOR THE NCI AND NIH FOURTH YEAR IN A ROW. THIS SHOWS CHAIR AND RANKING MEMBERS OF VARIOUS APPROPRIATION SUBCOMMITTEES AND SENATE HOUSE. WE HAD TESTIMONY THERE, WE HAD A TESTIMONY IN FRONT OF THE 21st CENTURY CURES TO THE ENERGY AND COMMERCE COMMITTEE IN THE HOUSE AND WE ARE EXPECTING TESTIMONY TO THE SENATE SUBCOMMITTEE AND HELP SUBCOMMITTEE NEXT WEEK RELATED TO 21st CENTURY CURES AND OTHER TOPICS. AS MENTIONED, THE HOUSE AND SENATE APPROPRIATIONS BILLS BOTH PROVIDE INCREASES FOR NIH AND NCI AND FULL FUNDING FOR THE MOON SHOT. THERE'S BEEN NEW PAST LEGISLATION RELEVANT TO THE NATIONAL CANCER INSTITUTE SO BOTH HAVING CHILDHOOD CANCER, THE STAR ACT HAS BEEN RECENTLY A MONTH OR TWO AGO SIGNED INTO LAW. THIS ACT DIRECTING THE NCI TO FURTHER RESEARCH EFFORTS IN PEDIATRIC CANCER SURVIVORSHIP AS WELL AS BIOSPECIMEN COLLECTION AND ASKS THE NCI TO HAVE CERTAIN REPORTING REQUIREMENTS AND ADVISORY EXPERTISE ON THE NCAB. WE BELIEVE THIS IS IMPORTANT LEGISLATION FOR THE NCI AND HOW WE DO CHILDHOOD CANCER RESEARCH, SURVIVOR RESEARCH AND DOING A NUMBER OF THINGS TO COMPLY WITH THE NEW LAW. THE RACE ACT WAS SIGNED ALMOST A YEAR AGO AND TODAY IN FACT I BELIEVE THE FDA ONCOLOGY BRANCH HAS DESCRIBED ONE OF THE IMPORTANT OUTPUTS OF THE RACE ACT WHICH IS A LIST OF RELEVANT TARGETS IN PEDIATRIC CANCER, ADULT CANCER TARGETS. THE REQUIREMENTS IS AT THE TIME OF FILING A PHARMACEUTICAL COMPANY SEEKING APPROVAL OF A NEW THERAPY DESCRIBE A PLAN WHEREBY THEY TEST THEIR THERAPY IN PEDIATRIC POPULATIONS SHOULD THE TARGET BE ONE OF THESE RELEVANT TARGETS FOR PEDIATRIC CANCER. THE IMPORTANT WORK O. RACE ACT IS PROVIDING A LIST OF WHAT THOSE RELEVANT TARGETS ARE. THE FDA RELEASED THAT TODAY. THAT EFFORT WAS LARGELY INFORMED BY WORK WITH THE NATIONAL CANCER INSTITUTE, IMPORTANT PART OF THE DECISION MAKING PROCESS, PROVIDING MOLECULAR PIOLOGY EXPERTISE AND GENOMIC EXPERTISE ABOUT PEDIATRIC CANCER. A LIST IS SEVEN PAGES LONG, FULL OF INTERESTING TARGETS AND WORTH LOOKING AT. A FEW WORDS ABOUT THE CANCER MOON SHOT. ALL THE THINGS I WILL DESCRIBE ARE WHAT I WOULD SAY EFFORTS WELL IN PROGRESS, MEANING IN ALL CASE IT IS FUNDING ANNOUNCEMENT IS APPEARED, WE HAVE RECEIVED GRANTS, WE HAVE REVIEWED PROPOSALS AND WE HAVE PLANS TO ANNOUNCE FUNDING RECIPIENTS AND ALL THESE FAIRLY SOON, A FEW OF THESE ANNOUNCEMENTS MAYBE REISSUED BASED ON THE FIRST CYCLE OF FUNDING BUT I THINK THERE'S EXCITING DEVELOPMENTS THAT WILL BE GOING LIVE SOON. ONE WAY TO TALK ABOUT THE MOON SHOT IS SHOWN HERE. THIS IS WORK OF THE BLUE RIBBON PANEL WHICH SURE THAT PROCESS IS FAMILIAR TO ALL OF YOU, WHICH IDENTIFIED TEN AREAS FOR FUTURE FUNDING AND FOR REAL FOCUS IN THE MOON SHOT, THESE WERE AREAS WHERE CLINICAL TRANSLATION WAS THOUGHT TO BE DIRECTLY APPLICABLE. SO YOU CAN SEE THESE ARE THE WAY WE BEND THEM, THE TEN THINGS AND HOW WE THINK ABOUT THEM. BUT I WOULD LIKE TO SHOW ANOTHER WAY OF LOOKING AT THIS THAT I THINK IS USEFUL WHICH IS THIS FIGURE WHICH IS A LOT MORE DETAIL BUT IT PROVIDES A SENSE OF SCALE OF MOON SHOT AND HOW MANY THINGS, HOW MANY FUNDING ANNOUNCEMENTS, HOW MANY GRANTS, SENT, PROGRAMS CREATED IN 17 AND 18 AND PLANNED FOR 19. MY VERSION I CAN CLICK THE LINKS AND THEY GO TO MORE DETAIL WHAT THESE ARE. YOU CAN SEE EVERY ONE OF THE TEN BLUE RIBBON PANEL IDENTIFIED AREAS HAS SIGNIFICANT INVESTMENTS MADE AND MORE PLANNED, IT REQUIRES THIS INTENSE ORGANIZATION TO ACCOUNT FOR THE OUTYEAR COSTS AND FUNDING PEAKS AND VALLEYS EARLIER FOR THE MOON SHOT. THE MOON SHOT IS A TREMENDOUS SCIENTIFIC OPPORTUNITY AT NCI AND ALLOW US TO WORK IN NEW AREAS BUT IT'S ALSO A REAL ADMINISTRATIVE CHALLENGE AND A TESTIMONY TO PEOPLE THAT ADMINISTER THE MOON SHOT, DANA SINGER AND HER COLLEAGUES WITHIN AN FDA -- WITHOUT INCREASING HEAD COUNT OF THE NCI IN A DRAMATIC WAY, TO KEEP A HANDLE ON THIS REALLY ROBUST EXCITING PORTFOLIO. I'LL MENTION A FEW THINGS SHOULD HAVE FUNDING DECISIONS ANNOUNCED SOON, TO GIVE APPROXIMATE IDEA OF THE ENTHUSIASM AND PLANS FOR THE MOON SHOT COMING SOON. FIRST IS IMMUNOONCOLOGY WORKSHOP, BEHAD INVESTMENTS IN THAT AND OTHER AREAS, ADDITIONAL SUPPORT IN THIS AREA, SO THE IDEA HERE IS THESE ARE BASIC DISCOVERY PRE-CLINICAL AND NETWORKS TO IMPROVE IMMUNOTHERAPY OUTCOMES IN BOTH CANCER AND HAVING INFLAMMATORY RESPONSE THAT IS HOT AND KARENS THAT DON'T HAVE MUCH IMMUNE RESPONSE, THAT ARE COLD. EXPERTISE OF COLLABORATIVE NETWORKS AND OTHER NCI PROGRAMS, LIKE THE PREVENT PROGRAM, THE IMMUNOPREVENTION EFFORTS OF THAT PROGRAM AS WELL AS THE MOON SHOT FUNDED ENTITY, K-99 MOON SHOT PROGRAM, ET CETERA. AND I THINK STRUCTURE SHOWN HERE FOCUSING ON FEW DISEASE TYPES BUT ALSO PREVENTION AND INTERACTING WITH OTHER RESOURCES. PROTEINS PROGRAM IS ONE OF THE FOCUS AREAS OF THE BLUE RIBBON PANEL. FOCUSES ON PROTEINS THAT ARE CREATED BY TOGETHER PROVIDING THESE PROTEINS WITH NOVEL ONCOGENIC ACTIVITIES IN SOME WAYS THESE HAVE BEEN VERY DIFFICULT DRUG TARGETS, DRUG TRANSCRIPTION FACTORS DIFFICULT DRUG AND PROCESS OR WAY OF MAKING PROGRESS AGAINST FUSION PROTEINS IS THOUGHT A TOPIC OF GENERAL IMPORTANCE IN PEDIATRIC CANCER, PARTICULARLY SOLID TUMORS. THIS ANNOUNCEMENT HAS GONE OUT AND ENVISION FUNDING A FEW PROJECTS, ADMINISTRATIVE COORDINATING CENTER FOCUSING ON SIMILAR FUSION ONCO PROTEINS WITH AN EFFORT TO UNDERSTAND BIOLOGY AND HOW IT AFFECTS CANCER AND THOUGHTS ABOUT THERAPEUTIC TRACTIBILITY AS TARGETS FOR THERAPY. THERE IS A LARGE INTERESTING MOON SHOT INITIATIVE ABOUT IDENTIFYING AND SCREENING AND SOME CASES TRYING TO DO PREVENTION PATIENTS WITH INHERITED CANCER SYNDROMES. LEE FREMINI AND LYNCH SYNDROME IN THE SORT. THE IDEA HERE IS TO IDENTIFY PATIENTS WITH INHERITED PREDISPOSITION HIGH RISK OF CANCER. THEN USE MULTI-DISCIPLINARY APPROACHES TO CONTACT SUCH PATIENTS TO HANDLE RELATED MEMBERS OF THE FAMILY AND PROVIDE PSYCHOSOCIAL SUPPORT AND DIAGNOSTIC SCREENING AND CARE AND FOLLOW-UP AS NEEDED. THE IDEA IS TO HAVE PROJECTS WORKING IN VARIOUS DIVERSE SETTINGS WHERE PATIENTS ENCOUNTERED NOT JUST HIGHLY TERTIARY SPECIALIZED CARE BUT REAL WORLD, THIS IS AN EXCITING EFFORT THAT DEALS WITH INTERESTING ISSUE AS BECOMING MUCH MORE PREVALENT FOR THE NCI WITH THE ADVENT OF EASILY ACCESSIBLE GERM LINE GENETIC TESTING WHICH IS RAPIDLY INCREASING IN SCOPE. HUMAN TUMOR ATLAS IS FURTHER ALONG, WE FUNDED SUPPLEMENT FUNDING AND NOW ARE PLANNED ON FUNDING ADDITIONAL CENTERS AND COORDINATING CENTER. THE IDEA HERE IS TO REALLY DEVELOP A 4D ATLAS OF HUMAN CANCER THAT BOTH MEASURE TUMOR, THE TUMOR MILIEU, THE IMMUNOENVIRONMENT AS WELL AS LONGITUDINALLY IN TIME SO YOU GET MULTIPLE DATA SETS RELEVANT TO THE CANCER AND SURROUNDING MILIEU AND MULTIPLE TIME POINTS AND THEN TO CHARACTERIZE THEM DEEPLY USING VARIOUS OMIC TECHNIQUES THEN TO HAVE A HUGE DATA SET THAT ONE HAS TO UNDERSTAND THROUGH VARIOUS KINDS OF MODELING AND OTHER DATA ANALYSIS APPROACHES. THIS IS AN EXCITING EFFORT WE ENVISION HIGHLY COLLABORATIVE WORK AND SIGNATURE EVENT FOR NCI DATA SET TO PROVIDE COMMUNITY IN THE FUTURE THE WAY THE CANCER GENOME ATLAS HAS BEEN A HIGHLY VALUABLE RESOURCE TO EXTRAMURAL RESEARCHERS. THE AXIS PROGRAM IS -- TAKES ON THE DIFFICULT PROBLEM OF IMPLEMENTATION OF KNOWN EFFECTIVE THERAPY, IN THIS CASE COLORECTAL SCREENING, SCREENING FOR COLORECTAL CANCER. THERE ARE A VARIETY OF WAYS TO SCREEN POPULATIONS IN HIGH RISK FOR COLON CANCER OR STANDARD RISK FOR COLON CANCER BUT ADOPTION OF THOSE METHODS IN THE COMMUNITY HAS BEEN A CHALLENGE. SO AXIS SEEKS BOTH MULTI-PHASE STUDIES THAT WOULD TRY AND PILOT TEST CERTAIN PROJECTS THEN ACTUALLY BRING THEM TO COMMUNITY WITH REAL INTEREST IN ADDRESSING DIFFICULT TO REACH POPULATIONS AND CANCER DISPARITIES, RURAL SUBGROUPS FOR EXAMPLE. I THINK IS REALLY IMPORTANT TOPIC FOR MOON SHOT. SO I'LL TALK THE RARE PATIENT ENGAGEMENT NETWORK. COLLABORATION BETWEEN INTRAMURAL PROGRAM AND EXTRAMURAL RESEARCHERS. IT IS BEGINNING TO GET STARTED AND IS AN EXCELLENT USE OF THE INTRAMURAL CLINICAL CENTER. AS I HAVE TALKED TO TO THIS GROUP BEFORE HOW THE NCI MAKES OPTIMAL USE OF BUILDING TEN CLINICAL CENTER IS AN AREA OF DISCUSSION FOR THE NCI AND CERTAIN KINDS OF TRIALS ARE GOOD FOR THE CLINICAL CENTER, CERTAIN ARE NOT, THIS IS ONE WE ARGUE IS VERY GOOD USE OF THE CLINICAL CENTER AND THAT IS, WHOING EXTERNALLY WITH RARE TUMOR PATIENTS IN THE EXTRAMURAL COMMUNITY AND BRINGING THEM HERE FOR CARE AND SECOND OPINIONS AND OTHER KINDS OF PARTICIPATION CLINICAL TRIALS. SO THIS IS A MOON SHOT FUND EFFORT TO BUILD THIS NATIONAL NETWORK FOR SELECTED PEDIATRIC AND ADULT TUMORS. IT HAS PARTNER NEAR SHIPS WITH ADVOCACY ORGANIZATION, PROVEN IMPORTANT FOR IDENTIFYING POPULATIONS OF PATIENTS AND ALSO PARTNERING WITH EXTRAMURAL CENTERS OF EXCELLENCE THAT HAVE EXPERTISE IN AREAS. THE WAY WE ENVISION PRESENTLY HAS TWO PARTS THAT ARE SIMILAR IN CAPABILITIES. ONE WE CALL CONNECT AND THAT IS THE CNS TUMOR EFFORT LED BY MARK GILBERT AND COLLEAGUES. MY PART IS PEDIATRIC AND ADOLESCENCE RARE TUMOR NETWORK LED BY BERGITA WEDERMAN, THE IDEA IS TO IDENTIFY CERTAIN POPULATIONS THAT ARE HARD TO STUDY BECAUSE THEY'RE RARE IN THE EXTRAMURAL COMMUNITY AND CREATE NETWORKS WHEREBY THE PATIENTS GET SOME LEVEL OF CARE, SOME COMMON FORMATS OF MOLECULAR ANALYSIS AN GENOMIC SUBTYPING AND ALSO STANDARDIZED CARE WHERE POSSIBLE. ALLOWING US TO SAY THINGS TO MAKE PROGRESS IN THESE ENTITIES WHICH ARE HARD TO STUDY TRADITIONALLY AT INSTITUTIONS. THIS BUILDS ON SUCCESS OF HER WORK IN F 1. SHE'S BEEN AN IP INVESTIGATOR IN -- INNOVATOR DEVELOPING THERAPEUTIC APPROACHES FOR NEUROFIBROMATOSIS. THAT SUCCESSFUL STORY IS ONE WE WOULD LIKE TO RECAPITULATE AT GREATER SCALE WITH THIS EFFORT. BRIEFLY I'LL MENTION THE R-50. I THINK WE CREATED A FEW NEW MECHANISMS A COUPLE OF YEARS AGO, THIS WAS ONE. I THINK THIS HAS LOT GOVERNMENTEN LESS ATTENTION AND OTHER ONES. THIS IS IMPORTANT. THIS IS AWARD INTENDED TO ENCOURAGE THE DEVELOPMENT OF NON-TENURE TRACK SCIENTISTS TO WANT TO CONTINUE TO BE SCIENTISTS. MY EXPERIENCE AS DIRECTOR IS HARD TO SUPPORT THESE INDIVIDUALS THAT ARE TERRIFIC SCIENTISTS THAT ARE REALLY GREAT AT THE BENCH OR IN THE LAB BUT DON'T ENVISION BECOMING FULLY FUNDED INDIVIDUAL INDEPENDENT INVESTIGATORS. WE THINK THIS IS A GREAT MECHANISM TO SUPPORT SUCH INDIVIDUALS THAT ARE HIGHLY VALUABLE TO CANCER CENTERS AND EXTERNAL ACADEMIC INSTITUTIONS BUT MAYBE TRADITIONALLY HARD TO SUPPORT FOR VARIETY OF REASONS. TYPICALLY THESE SORTS OF INDIVIDUALS DON'T GET FOR WANT OF BETTER TERM, THE LOVE FROM THE DEAN AND PROVOST UNLESS THEY BRING IN SALARY SUPPORT OF THEIR& OWN. SO THIS IS AN EFFORT TO ADDRESS THAT PROBLEM. I THINK WILL BE VALUABLE MY SENSE IS WHILE THE OUTSTANDING INVESTIGATOR AWARD HAS BEEN VERY POPULAR AND HIGHLY SUBSCRIBED TO, THAT THIS IS AN AREA WHERE WE STILL COULD -- WOULD LIKE TO SEE MORE APPLICATIONS. THE RESPONSE STUDY IS AN INTERESTING EFFORT THAT I WOULD LIKE THE TALK ABOUT BRIEFLY. THAT WAS JUST RECENTLY ANNOUNCED. SO I'M SURE THIS AUDIENCE IS HIGHLY FAMILIAR WITH THE STATISTICS RELATED TO PROSTATE CANCER IN AFRICAN AMERICAN MEN. AFRICAN AMERICAN MEN ARE MORE LIKELY DIAGNOSED WITH PROSTATE CANCER AND MORE LIKELY TO BE DIAGNOSED WITH MORTALITY IS MORE THAN DOUBLE NUMBER FOR ALL RACES. AND THE EXPLANATION IS NOT I WOULD SAY WELL UNDERSTOOD. I WILL PREDICT CONFIDENTLY LIKE ALL CANCER DISPARITIES THIS WILL BE COMPLICATED, IT WILL REPRESENT BOTH THINGS THAT HAVE TO DO BIOLOGY AS WELL AS ACCESS AS WELL AS MAYBE CERTAIN ENVIRONMENTAL FACTORS BUT IT NEEDS TO BE FLESHED OUT, FIGURING THIS OUT IS ARGUABLY ONE OF IF NOT THE MOST CANCER HEALTH DISPARITY QUESTION RIGHT NOW FACING THE NCI. IT'S ALSO BEEN A PROBLEM, IT'S BEEN ISSUE HARD TO STUDY FOR A VARIETY OF REASONS WE WERE SITING TO RECEIVE THE RESPONSE PROPOSAL, A RESEARCH ON PROSTATE CANCER GENETICS TUMOR MARKERS AND RELATIONS TO OTHER SOCIAL STRESSES AND ENVIRONMENTAL EXPOSURES BASED OUT OF USC BUT WITH SEVERAL COLLABORATOR INSTITUTIONS AND BUILD PRIOR STUDIES AMONG INVESTIGATORS FROM THESE INSTITUTIONS ARE PART OF THE AFRICAN ANCESTRY CANCER CONSORTIUM IN 28 ONGOING STUDIES SO THE VISION IS TWO COHORTS, A RETROSPECTIVE DO HOTTER OF 10,000 PATIENTS AND A NEW COHORT OF 10,000 PATIENTS CHARACTERIZED GENOMICALLY AS WELL AS NUMBER OF OTHER INSTRUMENTS. AS I SAID, THERE WILL BE 10,000 NEWLY RECRUITED MEN IN THE STATES SHOWN. AND WILL INVOLVE INTERACTION BETWEEN THE NCI WITH CHRIS HAYMAN UNC AND LEAD INVESTIGATOR SHOWN HERE AND IT ALSO IS GETTING SOME SUPPORT FROM IN ADDITION TO NCI THE INSTITUTE FOR MINORITY HEALTH AND HEALTH DISPARITIES AND THEN THE PROSTATE CANCER FOUNDATION SOTRY PAR TIDE FUNDING STRATEGY TO MAXIMALLY LEVERAGE SUPPORT FOR THIS EFFORT. I THINK IS VERY EXCITING INITIATIVE THAT'S JUST BEGINNING. AND CERTAINLY CREATE A BIT OF SENSATION IN THE MEDIA. THERE WAS A GREAT PICK UP OF THIS STORY, THIS IS THE LARGEST TRIAL ON THIS CLINICAL ISSUE THAT THE NCI EVER FUNDED. AS I SAID, IT'S CLEARLY AN AREA WHERE THE NCI NEEDS TO DO MORE WORK AND THAT HAS I THINK CAUSED LOT OF ENTHUSIASM IN THE MEDIA. SO THAT IS THE CONCLUSION OF MY REMARKS. I WILL BE HAPPY TO TAKE QUESTIONS, ONCE AGAIN THANK YOU ALL FOR MAKING YOURSELVES AVAILABLE IN A LOVELY AUGUST AFTERNOON TO HELP US DO THE WORKOUT NCI. IF THERE ARE ANY QUESTIONS I'LL TRY THE TAKE BY PHONE, RAISE YOUR HAND IF YOU HAVE A COMMENT OR QUESTION. I'M GETTING NO TAKERS HERE. I CAN'T TELL IF EVERYBODY'S HEADPHONES ARE ON. >> ANY QUESTIONS? >> ALL RIGHT. VERY GOOD. NEXT WE'LL MOVE ON TO OUR NEXT SPEAKER WHICH IS ONE OF THE YOUNG SCIENTISTS IN THE INTRAMURAL PROGRAM HERE AT THE NCI. JACK SHERN GAVE A PRESENTATION, IT WAS GREAT,TY THOUGHT I WOULD HAVE HIM DO IT AGAIN. TENURE TRACK, PEDIATRIC ONCOLOGIST IN THE PEDIATRIC ONCOLOGY BRANCH USING INNOVATIVE TECHNOLOGIES FOR PEDIATRIC CANCER RESEARCH AND WILL TELL US MORE ABOUT THAT TODAY. JIM. >> GREAT. THANK YOU SO MUCH FOR THE DR. SHARPLESS AND LIKE YOU SAID I AM JACK SHERN FROM THE PEDIATRIC ONCOLOGY BRANCH, CENTER FOR CANCER RESEARCH. I WILL TELL YOU A STORY ABOUT ENTER AND INTRAMURAL HETEROGENEITY AND PEDIATRIC SARCOMAS WE HAVE BEEN STUDYING. THIS IS A STORY OF SPLITTERS AND LUMPERS. WHAT DO I MEAN BY THAT? PEDIATRIC ONCOLOGISTS AND PEOPLE THAT STUDY RARE TUMORS ARE A TREAT, RARE TUMORS, BY NECESSITY LUMPERS. SO WE HAD TO TAKE OUR RARE DISEASES AND TREAT THEM ALL THE SAME FOR A LONG TIME. ONE PARTICULAR DISEASE THAT I HAVE BEEN WORKING ON IS CALLED RAD DOE MYOSARCOMA, THE MOST COMMON SOFT TISSUE SARCOMA IN ALL OUR GRANTS AND IT IS A RARE DISEASE, OCCURS IN 350 KIDS PER YEAR. I WILL TELL YOU THE STORY ABOUT ALLEY WHO YOU SEE HERE WHO I MET IN 2010 WHILE FELLOW AT JOHNS HOPKINS, ALLEY CAME TO ME WHEN SHE WAS FOUR TURNING FIVE, THIS IS A PICTURE OF HER BEEN DIAGNOSIS, A COUPLE OF WEEKS BEFORE. SHE HAS SOME SWELLENING HER LEFT CHECK THERE. -- CHEEK THERE. SHE HAD CHUBBY CHEEKS AND LOST THEM RECENTLY BUT THE LEFT SIDE HAS A LESION HER MOM NOTICED, BROUGHT TO THE DENTIST ATTENTION AND EVENTUALLY GOT TO US AT JOHNS HOPKINS. WHEN WE BIOPSIED THIS LESION, WE CAME BACK WITH RAD DOE MYOSARCOMA, NOT OTHERWISE SPECIFIED. THAT'S THE PATHOLOGY REPORT THAT'S ALL THE MOLECULAR INFORMATION WE HAD ON THIS PATIENT. REMEMBER, THIS IS 2010 JOHNS HOPKINS SO NOT LIKE WE WERE IN THE THIRD WORLD COUNTRY TRYING TO DIAGNOSE THIS. THIS IS ALL TECHNIQUES WE HAD AVAILABLE. NOT OTHERWISE SPECIFIES MEAN FOR ALLEY, SHE GETS ALMOST A YEAR OF THERAPY, IT'S CYTOTOXIC THERAPY. YOU CAN SEE THE REGIMEN HERE IN THE MIDDLE. WE USE THE SAME CHEMOTHERAPY BACKBONE WE HAVE BEEN USING FOR DECADES. CHRISTINE CYCLOPHOSPHAMIDE. GETTING WEEKLY TREATMENTS WITH THOSE DRUGS. SHE GETS RADIATION THERAPY AND SHE GETS A SURGICAL TREATMENT OF HER DISEASE AS WELL. ALLEY WAS TOUGH AND MOM WAS GOOD AND SHE CAME THROUGH THIS REMARKABLY WELL, WHAT YOU DON'T SEE ARE THE YEAR AFTER I TREATED HER. SO HER TEETH NEVER REGREW WHICH IS AN INTERESTING THING. SHE GOT RADIATION TO THAT SIDE SOFT JAW THAT CAUSES PROBLEMS FOR HER TODAY, THAT JAW DOESN'T GROW THE SAME RATE AS THE OTHER SIDE. WE PUT IN A G TUBE TO FEED HER, SHE WENT TWO MONTHS WITH SUPPLEMENTAL FEEDS TO FEED HER. YOU CAN SEE THE LIFE LONG SCARS THIS CAUSED FOR THIS LITTLE GIRL. WHAT DOES THAT MEAN, WE HAVE TO SUBCLASSIFY THIS DISEASE AND THIS IS AN EFFORT THAT WE ONCOLOGY GROUP IN THE INTRAMURAL PROGRAM TO DO NEXT GENERATION SEQUENCING ON THESE TUMORS OVER THE PAST COUPLE OF YEARS. THIS IS A SERIES OF 147 TUMORS WE LOOKED AT WITH WHOLE GENOME SEQUENCING RNA SEQUENCING AND EXOME SEQUENCING. THE THING THAT JUMPED OUT IMMEDIATELY IS THAT RAD DOE MYOSARCOMA IS TWO DISEASES, ONE DRIVEN BY ONE OF THESE FUSION ONCO PROTEINS YOU HAVE BEEN HEARING ABOUT, PACKS 3 FOXO TRANSCRIPTION FACTORS IN THE MUSCLE DEVELOPMENT PROGRAM. GROUP OF TUMORS THAT ARE HETEROGENEOUS THOUGH THEY ARE MUTATIONS, INTERESTINGLY ENOUGH THESE PATIENTS GET MUTATIONS IN NRAS KRAS OR HRAS. RECEPTOR TYROSINE KINASE CALLED FGR 4 WE PUT WORK INTO. P-53, PI KCA AND F 1 SIGNALING PATHWAY TYPE DISEASE. SO THE PROBLEM WITH THAT STUDY IS WE DIDN'T HAVE CLINICAL ANNOTATION ON THOSE SAMPLES. DELINKED FROM THE TUMOR SAMPLE BANKED AND WE COULDN'T MAKE ANY SORT OF PROGNOSTIC MARKS OUT OF THAT. SO WHAT WE NEEDED TO DO WAS GO BACK AND HAVE A MORE CLINICALLY ANNOTATED COHORT. THE PROBLEM IS THAT THE DISEASE IS DEFINED CLINICALLY. WE BASICALLY HAVE BINS, LOW, INTERMEDIATE AND HIGH RISK. CLINICAL FEATURES OF THE PATIENT, NO MOLECULAR INFORMATION UP UNTIL 2010, 2011 WHEN THIS THIS FIRST TO REPORT FUSION ONCO PROTEIN WAS BAD PROGNOSTIC INDICATOR, IF YOU HAD PACKS 3 FOXO YOU DID WORSE THAN THE REST OF THE POPULATION. WE DON'T KNOW ABOUT THE REST OF THE TUMORS, PACKS 3 FOXO IS IN A SMALL SUBSET. SO CAN WE USE GENETIC INFORMATION TO FURTHER CLASSIFY THESE. WE WENT INTO ONCOLOGY GROUP, GIVE AS MANY TUMORS AS YOU HAVE WELL CLINICAL GOOD CLINICAL ANNOTATION WITH. SEND THEM TO THE NCI WHERE WE EXTRACT THEM. THIS HAS BEEN A BIT OF A PROJECT BECAUSE WHAT WE ARE WORKING WITH IS UNSTAINED SLIDES FROM THINGS LIKE NEEDLE BIOPSIES, SO EXCEEDINGLY SMALL AMOUNT OF TISSUE, WE ONLY GOT TWO UNSTAINED SLIDE FROM EVERY CASE. WE DO DNA SEQUENCING AND PARALLEL PROJECT DOING RNA SEQUENCING AS WELL. WE ARE CALLING MUTATIONS IN THESE 39 GENES, TIER 1 SO OBVIOUS MUTATIONS IN HOT SPOTS, STOP CODONS, NDELL, HIGH COPY NUMBER RAMIFICATIONS OR DEEP DELETIONS OF THESE GENE, ANY GENES THAT WE FOUND CURRENTLY FOUND IN RAD DOE MYOSARCOMA. WE STARTED WITH 300 COG CASES, DROP OUT THANK YOU TO INADEQUATE NUCLEOTIDES. IN TOTAL SEQUENCED 347 CASES FROM THE CHILDREN'S ONCOLOGY GROUP COHORT. 66 HAVE A PACKS 3 OR PACKS 27 FOXO FUSION. IN TOTAL 281 FUSION NEGATIVE COHORT WE WANT TO SUBSTRATIFY BETTER. THAT WAS NOT GOING TO POWER MANY STUDIES STUDIES SO WE TEAMED UP WITH A GROUP FROM THE UNITED KINGDOM, JANET SHIPLY'S GROUP HAD 316 CASES. SO IN TOTAL WE'RE GOING TO REPORT ABOUT 600 CASES OF FUSION NEGATIVE RHABDOMYOSARCOMA. THE CLINICAL CHARACTERISTICS OF THIS COHORT WITH OF THE COG COHORT ARE INTERESTING. WE HAVE A SKEW TOWARD MADE POPULATION BECAUSE THERE'S A LARGE GROUP OF PARATESTICULAR TUMORS IN THIS DISEASE. THE HISTOLOGY IS A BIT OF A NIGHTMARE. WE HAVE THREE INDEPENDENT PATHOLOGISTS LOOKING A THESE CASES AND TO GET CONSENSUS FROM THE PATHOLOGIST HAS BEEN DIFFICULT. NOT SURPRISING IN A RARE TUMOR. WHAT I CAN SAY IS THAT THE MUTATION FREQUENCY HAPPENS ABOUT MEDIAN OF ONE PER TUMOR BUT THERE'S A HUGE RANGE, WE HAVE TUMORS WE DON'T FIND ANY LESION AND WE HAVE TUMORS WHERE WE HAVE FIVE POTENTIAL DRIVER LESIONS. HERE IS A SUMMARY OF THE GENES THAT WE FIND MOST FREQUENTLY MUTATED. AGAIN, 281 FUSION NEGATIVE CASES. THE GENE BCOR IS MOST FREQUENTLY MUTATED IN THIS COHORT. WE FOUND THIS IN THE INITIAL STUDY. WE ARE FINDING A HIGHER RATE IN THIS COHORT AND WE THINK THIS IS BECAUSE OF TARGETED PANEL SEQUENCING PICKING UP THESE LESIONS, WE PROBABLY HAD FALSE NEGATIVES AND INITIAL STUDIES. SAME WITH NF 1 AND P-53 WHERE DEEP SEQUENCING WE PICK UP MORE MUTATIONS. MUTATIONS. ON THE FUSION POSITIVE SIDE WE HAD 66 CASES FUSION POSITIVE FREQUENTLY GOES WITH AMPLIFICATION OF CDK 4 OR AMPLIFICATION OF MIKN. WHEN YOU LOOK AT THE CLINICAL INFORMATION YOU GET INTERESTING RESULTS, ONE THING THAT JUMPED OUT OF THIS, IF YOU HAVE A FUSION NEGATIVE CASE THAT'S ON THE EXTREMITY, A HIGH PERCENTAGE OF THESE HAVE A P-53 AS A DRIVER LESION, AND IT DOESN'T APPEAR A RAS MUTATION, THIS IS A DISTINCTION SUBTYPE OF THE DISEASE, THE SAME HAPPENS WHEN YOU CLASSIFY BY FAILURENARY CASES. ALL THE DICE ARE ONE MUTATION WE FOUND HAPPEN IN THAT PARTICULAR ANATOMICAL LOCATION SO AGAIN SHOWING ON TO SOMETHING STRATIFYING BETTER. ORBITAL DO VERY WELL, THERE'S AN OBVIOUS MUTATION THAT KRAS DO NOT HAPPEN IN THAT DISEASE AND THEY ARE RESTRICTED TO THE HEAD AND NECK REGION, MOSTLY MEN JEEL, I'LL TELL YOU ABOUT THOSE IN MINUTE. ONE TUMOR DOESN'T EQUAL ONE GENETIC LESION. SO YOU SEE HERE THE NUMBER OF LESIONS PER TUMOR. CERTAIN WILL I WE HAVE A LARGE NUMBER OF CASES WHERE WE HAVE ONE PARTICULAR DRIVER WE HAVE TO PUT OUR FINGER ON. THERE'S MANY OF THESE CASES THAT HAVE MANY MORE MUTATIONS ALONG THIS PATHWAY. THIS LEADS YOU TO THE HYPOTHESIS MAYBE THIS IS A POLYCLONAL DISEASE OR SUBCLONAL DISEASE. WE CAN ALSO START TO MINE THIS FOR QUESTIONS LIKE DOES INCREASE NUMBER OF MUTATIONS LEAD TO WORSE OUTCOME. SO THAT MODELS OF THIS DISEASE ARE POOR AS WELL. SO THE PEOPLE THAT DEVELOP MODEL SYSTEMS WANT TO KNOW WHAT GENE MUTATIONS GO WITH EACH OTHER. THIS STUDY WILL HELP PUT THAT ON THE MAP. YOU SEE THINGS LIKE THAT MIOD 1 MUTATION WHICH NEVER GOES BY ITSELF AND ALWAYS HAS A CORRESPONDING MUTATION OR THINGS LIKE HRAS WHICH ARE FREQUENTLY BY ITSELF. MORE CLINICAL OBSERVATIONS. IF YOU JUST TAKE THE INFANTS IN THIS STUDY, LESS THAN A YEAR OLD, THIS IS A DISEASE OF RAS. YOU CAN SEE THE FREQUENCY OF MUTATIONS IN THE LESS THAN ONE-YEAR-OLDS, HRAS MUTATIONS AND KRAS MUTATIONS. THIS IS ACTUALLY AN INTERESTING FINDING BUT THE ALLELE FREQUENCY MUTATION OF HRAS MUTATION IS MUCH HIGHER. SO THIS IS PROBABLY A DOUBLE HIT POTENTIALLY IN THE GERM LINE WHERE THEY HAD LOSS OF HETEROZYGOSITY AND CHROMOSOME 11, WHICH CARRIES THE IGF LOCUST WE'RE SO INTERESTED IN FOR SO LONG. ALSO IF YOU DISTRIBUTE THE R AXS ISOFORM MUTATIONS ACROSS AGE YOU GET THIS NICE DEVELOPMENTAL PEAK I THINK. THIS IS THE HRAS MUTATIONS IN INFANT, LESS THAN A YEAR OLD, HUGE PERCENTAGE OF CASES. THAT GOES AWAY BY TIME WE GET TO ADOLESCENTS. IN TODDLERS WE GET KR ACTIONS MUTATION AND ADOLESCENTS IS NRAS DRIVEN THING. UNIQUE ABOUT THE BIOLOGY OF THIS DISEASE MORE WORK TO BE DONE THERE. SO I SET OUT TO FIND PREDICTIVE MARKERS THAT WE CAN USE TO STRATIFY THESE PATIENTS BETTER AND HERE IS THE FIRST MOST OBVIOUS ONE. IF YOU HAVE A MUTATION YOU HAVE A DISMAL OUTCOME. THESE PATIENTS ARE A LITTLE BIT OLDER SO THESE ARE ADOLESCENTS, YOUNG ADULTS, MEDIAN AGE WAS 14.4 IN CHILDREN'S ONCOLOGY GROUP. OURS ARE RESTRICTED TO THE HEAD AND NECK, ANATOMIC LOCATION. MIOD 1 NEVER GOES BY ITSELF, IT ALMOST ALWAYS HAS A PIKCA MUTATION OR CELL CYCLE GENE ALTERATION AS WELL. THERE'S BEEN SPECULATION IN THE LITERATURE THERE'S A DISTINCT HISTOLOGY TO THIS. I DON'T THINK THAT WILL HOLD UP. WE REALLY NEED TO GET THE GENETIC INFORMATION TO BE ABLE TO DIAGNOSE PROPERLY. THE OTHER LESION THAT POPS OUT IS P-53. NOTHING UNIQUE ABOUT P-53 MUTATION IN THE RHABDOMYOSARCOMA DISEASE. BUT CERTAINLY ALLOWS US TO SUBSTRATIFY THESE PATIENTS SO IN RED HERE I HAVE THE P-53 MUTATIONS AND ALL COMERS IN THE OTHER DO HOTTER. THIS HOLDS UP EVEN IF YOU STRATIFY BY CLINICAL RISK STRATIFICATION. IF YOU LOOK AT THE FUSION POSITIVES WE HAVE TWO MARKS HERE THAT ARE POOR PROGNOSTIC MODIFIERS OF THE DISEASE. IF YOU HAVE PACKS 3 FOXO AND MIK AMPLIFICATION, DISMAL OUTCOME HERE, YOU CAN SEE THOSE GUYS DONE DO WELL. CDK 4 AMPLIFICATION HAS A PRETTY DISMAL OUTCOME AS WELL. SO I THINK WHAT WE'RE DOING NOW IS STARTING TO DEFINE THIS DISEASE BETTER GENETICALLY WHICH WILL HELP US IMPROVE OUR RISK STRATIFICATION AND HOPEFULLY THERAPIES. I WORK AT THE CLINICAL CENTER AND I DON'T SEE UP FRONT RHABDOMYOSARCOMA MUCH, I SEE RELAPSED THREE, FOUR, FIVE TIMES AFTER DIFFERENT REGIMENS REGIMENS SO WHAT I HAVE BECOME INTERESTED IS INTRAHETEROGENEITY. AND THIS GRAPH DESCRIBES IT THE BEST THAT I CAN. THIS IS A SAINT JUDE STUDY OF TWO PATIENTS THEY HAD. WHAT YOU WILL SEE IS THERE IS A SUBCLONAL ELEMENT OF THIS DISEASE. HERE IS YOUR DIAGNOSTIC BIOPSY IN THIS PARTICULAR PATIENT. THEY HAVE IDENTIFIED TWO CLONES HERE, ONE, 97% OF THE TOUR MORE, ONE THREE PERCENT OF THE TUMOR T TOPSIDE RADIATION AND SURE ENOUGH YOU KILLED THE 97% CLONE, WHAT COMES THROUGH IS THAT 3% CLONE. THIS IS REMINISCENT OF MULTIPLE TOW MORE TYPES AT THIS POINT SO WHAT WE NEED ARE TOOLS TO START TO DISSECT THE HETEROGENEITY OF THESE TUMORS. AND SEQUENCING IS STARTING TO GIVE US THOSE TYPE OF TOOLS, WHAT WE NEED TO DO IS START TO TAKE THE INDIVIDUAL PIECES THAT ARE ALL MIXED TOGETHER AND PUT THEM INTO THEIR BINS AND PROFILE AS FAR AS MECHANISMS TO DEVELOP NEW THERAPIES. SO I HAVE BEEN USING A LOT OF SINGLE CELL SEQUENCING. WE ARE DOING THIS FROM THE OR IN BUILDING TEN. WE WILL REMOVE SKULL BASED METASTATIC TUMOR. WE WILL BRING IT UP INTO A SINGLE CELL SUSPENSION AND PERFORM SINGLE CELL RNA SEQUENCING ON THESE TUMORS SO THIS IS 60,000 CELLS WE PROFILED IN THIS WAY. AND THERE'S SOMETHING FOR EVERYONE IN THIS -- IN THESE EXPERIMENTS. THE IMMUNE THERAPISTS LOVE THESE BECAUSE YOU CAN PROFILE THE IMMUNE CELLS INFILTRATING THE TUMOR. PEDIATRICS SO FAR, THAT'S NOT SUPER INTERESTING BECAUSE FEW CELLS ARE IN THESE TUMORS. YOU CAN SO E THIS POPULATION IS THE ONLY IMMUNE CELLS FOUND IN THIS TUMOR SO QUITE COLD AS WE CALL IT THESE DAYS. THE MICROENVIRONMENT, PEOPLE THAT STUDY MICROENVIRONMENT SEE TUMOR ASSOCIATED FIBROBLASTS OR SUPPORTING CELLS. THOSE HAVE A DISTINCT EXPRESSION PROFILE AS WILL. ON THE TUMOR SIDE WE SEE SUBGROUPS OF CELLS SO THESE CELLS UP HERE ARE CLEARLY GOING THROUGH MYTOSIS BY THEIR EXPRESSION PROFILE, SO TOPO ISOMERASE, SENTRYSOMAL GENES AND KINESANS ARE ALL ELEVATED IN THIS SUBGROUP OF TUMORS YOU CAN SEE THINGS LIKE RARE SUBPOPULATIONS OF CELLS IF YOU LOOK AT ENOUGH. THIS IS A TUMOR CELL POPULATION HERE THAT'S QUITE DISTINCT FROM THE REST OF THE TUMOR. THIS IS CHARACTERIZED BY TWO GENES THAT ARE HIGHLY UPREGULATED IN THIS PARTICULAR POPULATION. BURK 3 AND KLF 10. BURK 3 IS ASSOCIATED WITH ANTI-APOPTOTIC EFFECT AND KLF 10 IS A TRANSCRIPTION FACTOR THAT CONTROLS MYOBLAST DIFFERENTIATION. SO POTENTIALLY THINGS THAT WE CAN GO BACK TO THE LAB AND MODEL. OTHER TYPES OF TUMORS ARE BECOMING MUCH MORE INTERESTING TO LOOK AT. THINGS LIKE THIS ATYPICAL NEUROFIBROMA I HAVE GOTTEN FROM BRIGETTE COHORT TALKED ABOUT EARLIER, THIS IS A PATIENT WE HAD CONCERN FOR THIS TRANSFORMING TO A MALIGNANT NERVE SHEATHE TUMOR. PEOPLE HAVE BEEN TRYING TO FIGURE HOW THESE THINGS WORK. THEY'RE FREQUENTLY DRIVEN BY A NEOPLASTIC SWAN CELL, A SUBGROUP OF CELLS WITHIN THE TUMOR. THESE TUMOR GENIC CELLS ARE SECRETING THINGS LIKE CSF 1 AND KIT LIGAND WHICH GETS ACTIVATED BY THE IMMUNE SYSTEM, THINGS LIKE MACROPHAGES AND MASS CELLS ENTER THESE TUMORS AND BECOME A MAJOR POPULATION WITHIN THE TUMOR. FIBROBLASTS ACTIVATED AS WELL. THIS IS A FEEDBACK CYCLE. THIS IS WHY THESE TUMORS ARE FREQUENTLY LARGE. SO AGAIN, SAME TECHNIQUE UP INTO SINGLE CELL SUSPENSION DO SINGLE CELL PROFILING. WHAT I WILL POINT OUT IS ALL THESE OTHER CELLS HERE ARE IMMUNE CELLS OR SUPPORTING CELLS. TUMOR GENIC POPULATION OF THIS CELL IS THIS LITTLE CLUSTER 19 RIGHT HERE. SO A VERY SMALL NUMBER OF CELLS IN THIS BIG TUMOR WHERE IDENTIFIED AS NEOPLASTIC SWAN CELL. IF YOU DID BULK RNA SEQUENCING OF THIS YOU WILL NOT FIND THE PROFILE OF THE SWAN CELL, YOU WILL FIND THE PROFILE OF EVERYTHING ELSE. SO WE CAN DEFINE THESE POPULATIONS. THEN START TO LOOK AT THE EXACT PROFILE THESE THINGS. SURE ENOUGH CSF 1, THE CANDIDATE DRIVER OF THIS TUMOR, IS HIGH IN POPULATION 19. ALL THE REST AS SAID ARE PRODUCING RECEPTOR TO THIS, CSF 1R. SO LOOKING PRETTY GOOD. BUT SINGLE CELL USES A TOP BIOMARKER AS A GENE CALLED IL 34 IN CLUSTER 19. WHAT IS IL 34? IT'S THE UNDERSTUDIED PARTNER OF CSF 1. WHAT THIS EXPERIMENT IS TELLING US, CSF 1 IS PROBABLY A PLAYER IN THIS DISEASE. BUT SOMETHING WE HAVE NEVER SEEN BEFORE IS IL 34 IS BEING PRODUCED BY THE NEOPLASTIC SWAN CELL SO A GREAT DISCOVERY TOOL FOR THESE EXPERIMENTS. IT'S SCARIER WHEN YOU PUT CELL LINES THROUGH THIS, SO WE HAVE BEEN WORKING ON H STACK INHIBITORS IN RHABDOMYOSARCOMA FORSYME TIME, THIS TURNS OFF THE PACKS GENE AS WELL AS DOWNSTREAM TARGETS. THIS IS WHAT A CELL LINE LOOKS LIKE, A CLOUD, PRETTY HOMOGENOUS BUT THEN IF YOU START TO DRILL DOWN ON THE DOWNSTREAM TARGETS THAT YOU CAN NOW SEE, GENES THAT WE THOUGHT OF IMPORTANT IN THIS DISEASE FOR A LISTENING TIME LIKE SOX 8 AND MIOD 1 TREATED WITH H STACK INHIBITOR, WHAT YOU SEE IS THEY ARE FREQUENTLY CELLS NOT PRODUCING SO, 8 IN MIOD 1, I WAS UNDER THE IMPRESSION EVERY RHABDOMYOSARCOMA PRODUCED THESE GENES. IF TREATED WITH H STACK INHIBITOR THEY GO UP, BY ONE HOUR AND BY SIX HOURS WE TURN THINGS OFF. THIS IS REALLY HIGHLIGHTING THAT THERE'S A HUGE AMOUNT OF CELLULAR HETEROGENEITY. SO IN MY NAIVE UNDERSTANDING OF THIS SYSTEM, WHAT I THOUGHT WAS ALL CELLS PRODUCING MIOD 1 OR SOX 8 ALL THE TIME, IF I ADD THE INHIBITOR THEY RECRUIT AND ADDED MORE. IN REALITY, SOME CELLS ARE NOT PRODUCING DOWNSTREAM TARGETS AT CERTAIN CELL CYCLE STAGES. IF I ADD H STACK INHIBITOR NOW I CAN RECRUIT THEM. SO THERE'S A HUGE AMOUNT OF HE ROW GENEITY IN OUR CELL LINES, PERHAPS NOT SURPRISING BUT MAKES IT A LITTLE BIT HARDER TO STUDY THESE DISEASES. SO I WILL STOP THERE AND SAY THAT THIS HAS BEEN A HUGE COLLABORATIVE EFFORT USING THE INTRAMULE RESOURCES AT THE CCR AND TEAMING UP WITH THIS POWERFUL GROUP THE CHILDREN'S ONCOLOGY GROUP WHICH HAS THE SAMPLES AND THE CLINICAL ANNOTATION THAT GOES ALONG WITH THEM. WE HAVE SEED MONEY FROM SAINT BALL DISTRICT'S AS WELL. I WILL ALSO MENTION I'M PART OF THIS PROGRAM, THE CLINICAL SCHOLARS PROGRAM AT NIH, IT'S A REALLY EXCEPTIONAL OPPORTUNITY WHERE YOU GET YOUNG RESEARCHERS WITH CLINICAL OR TRANSLATIONAL INTERESTS. IT'S AN 8 YEAR PROGRAM SO VERY NICE STABLE SITUATION FOR A YOUNG INVESTIGATOR WHERE IN THE FIRST FIVE YEARS YOU GET A TENURE TRACK POSITION IN THE INTRAMURAL COMMUNITY. THEN YOU GET THE OPTION TO STAY INTRAMURAL OR MOVE TO AN EXTRAMURAL POSITION AND THIS PROGRAM IS ACTIVELY RECRUITING RIGHT NOW. SO I'LL STOP THERE AND TAKE ANY QUESTIONS. >> [APPLAUSE] >> THANK YOU, TERRIFIC. QUESTIONS FOR JACK? GUESS THAT'S HARD WHEN PEOPLE ARE VIRTUAL. >> DR. SHARPLESS DIDN'T GET ANY I DON'T DESERVE ANY EITHER. >> TERRIFIC. THANK YOU VERY MUCH, JACK. GREAT WORK. SO NEXT WE HAVE TWO AD HOC WORKING GROUP REPORTS FOR TODAY'S MEETING. THE FIRST ONE IS AN INTERIM REPORT FROM THE AD HOC DATA SCIENCE WORKING GROUP AND DR. CHARLES SAWYERS WILL BE PRESENTING ALONG WITH DR. NEAL LEVY. CHARLES, I'LL TURN IT OVER TO YOU. >> OKAY. HI, EVERYONE. CAN YOU HEAR ME? I'M NOT HEARING ANYTHING. HELLO. >> WE CAN HEAR YOU. >> >> OKAY. AND I JUST WANT TO CHECK THAT MIA ALSO ON THE PHONE AND CAN BE HEARD. >> CAN YOU HEAR ME NOW? >> YES. >> THANK YOU FOR YOUR PATIENCE. >> ON BEHALF OF MIA AND MYSELF WE'RE REALLY EXCITED TO PRESENT THIS REPORT. JUST TO GIVE A LITTLE CONTEXT ACTION YOU MAY REMEMBER I BELIEVE IT WAS THE FEBRUARY MEETING NED ANNOUNCED THE CREATION OF NEW AD HOC COMMITTEE ON DATA SCIENCE. THE REASON FOR FORMING THIS COMMITTEE IS FAIRLY OBVIOUS. THERE'S LOTS OF TALK ABOUT BIG DATA IN MANY FIELDS PARTICULARLY IN CANCER WITH ALL THE OMIC TECHNOLOGIES, YOU HAVE SEEN WHAT'S HAPPENED WITH MEDICAL INFORMATICS AS WELL AND PROMISE AND CHALLENGE OF MINING CLINICAL DATA FROM ELECTRONIC MEDICAL RECORDS, TREMENDOUS INTEREST IN COMPUTER SCIENCE BASED MACHINE LEARNING AND ARTIFICIAL INTELLIGENCE TO EXPEDITE PATHOLOGY OR RADIOLOGY REPORT GENERATIONS, AS WELL AS ENORMOUS COMMERCIAL INTERESTS AND INVESTMENTS IN THIS SPACE. SO WHEN NED DECLARED THIS AS ONE OF HIS TOP PRIORITIES, AND THEN CALLED ME TOGETHER WITH MICSA AND ASKED US TO CHAIR THIS COMMITTEE WE BOTH WERE DELIGHTED TO DO SO. SO I WANT TO START BY GIVING YOU A FLAVOR OF THE COMPOSITION OF THE COMMITTEE. SOMETHING HAS NOW HAPPENED WITH MY COMPUTER. SO I WON'T GO THROUGH EVERYONE ON THIS LIST. YOU SEE SOME FAMILIAR FACES AND I REFER YOU TO THE WHITE PAPER FOR THE FULL DESCRIPTION OF EVERYONE. BUT MIA WHO WILL INTRODUCE HERSELF MORE IN A MINUTE IS DIRECTOR OF THE CANCER HEALTH INFORMATICS AND STRATEGY GROUP AT VANDERBILT, ALSO A MEDICAL ONCOLOGIST. JUST A FEW PEOPLE WHO YOU MIGHT NOT KNOW THAT WELL, WARREN KIBBE I THINK YOU KNOW FROM PRIOR MEETINGS, HE'S MOVED ON, FORMER DIRECTOR OF THE CENTER OF BIOMEDICAL INFORMATICS AND INFORMATION TECHNOLOGY, C BIT, HAS MOVED TO A POSITION AT DUKE AND IS GREAT TO HAVE HIM GIVE HIS PERSPECTIVE ON THIS COMMITTEE. WE PULLED IN PEOPLE FROM OTHER AREAS OUTSIDE THE USUAL CANCER GROUP AS A COUPLE OF EXAMPLES REGINA BARZILE, COMPUTER SCIENTIST ANDS ARTIFICIAL INTELLIGENCE SPECIALIST, ELECTRONIC ENGINEER AT MIT. SHE WAS AN AVID PARTICIPANT IN OUR DISCUSSIONS. GEORGE SHRIFSAC, A MEDICAL INFORMATICS LEADER AT COLUMBIA BUT NOT IN THE CANCER SPACE AND HAS INTEREST IN BRINGING SOME OF HIS EXPERTISE INTO THIS SPACE. A FEW COMMERCIAL PEOPLE, FOR EXAMPLE MIMI (INAUDIBLE) FROM NOVARTIS IN CHARGE OF REAL WORLD DATA PROGRAM. IN THE BIOPHARMA INDUSTRY AS WELL AS FDA, THERE'S TREMENDOUS INTEREST IN THIS SPACE. ANOTHER COMMERCIAL PERSON, VINCE MILLER, CHIEF MEDICAL OFFICER AT FOUNDATION MEDICINE, OTHER MEDICAL INFORMATICS EXPERTS REBECCA JACOBSON FROM UNIVERSITY OF PITTSBURG MEDICAL CENTER ENTERPRISES, VICE PRESIDENT FOR ANALYTIC AND OTHER NAMES YOU MIGHT RECOGNIZE INCLUDING PATIENT ADVOCATES SUCH AS AMANDA HADDOCK. SO I TOOK THE TIME TO TELL YOU THAT BECAUSE THIS IS A COMMITTEE THAT FIRST OF ALL ACCEPTED THE INVITATION QUICKLY ON SHORT NOTICE. AND REPRESENTS A PRETTY BROAD SPECTRUM OF EXPERTISE. SO THE NEXT SLIDE GIVES YOU A SENSE HOW QUICK WE PULLED TOGETHER. OPT FAR LEFT YOU SEE NOVEMBER AND DECEMBER LAST YEAR WHEN NED STARTED TALKING THE IDEA OF SUCH A COMMITTEE, ASKED MIA AND I TO CO-CHAIR, WE BROUGHT IN QUICKLY OR WERE OFFERED HELP FROM BETSY SUE WHO IS IN THE ROOM AND IS PART OF THE C BIT PROGRAM AND THEN TONY (INDISCERNIBLE) ACTING DIRECTOR TOGETHER WITH WARREN, THIS SUBGROUP IDENTIFY KEY PEOPLE WE WANTED TO BRING IN. AND ASSEMBLE THE TEAM THEN BEGIN PROCESS OF THE COMMITTEE WORK IN THE SPRING AND ROUGHLY APRIL TIME FRAME WITH A FEW PRE-MEETINGS TO INTRODUCE OURSELVES. QUITE HONESTLY I WAS A BIT CONCERNED ABOUT ACCEPTING THIS BECAUSE THIS IS SUCH A BIG BROAD TOPIC, BROAD SET OF INDIVIDUALS WITH DIFFERENT INTERESTS. I WAS A LITTLE CONCERNED WE WOULDN'T CONVERGE ON ANY NEW OR CONSENSUS KIND OF THINGS. BUT WE WRESTLED EVERYONE'S CALENDAR DOWN TO FACE TO FACE MEETING IN MAY, GRATEFUL TO HAVE NED JOIN US FOR NEARLY TWO HOURS AT THE BEGINNING TO LAY OUT THE CHARGE TO THE COMMITTEE AND PARTICIPATE IN THE EARLY DISCUSSIONS OF IDEAS THAT PEOPLE WERE ASKED TO BRING WITHOUT PRIOR VETTING TO THIS ROUND TABLE DISCUSSION. WHAT TRANSPIRED IN THAT ONE DAY WAS WHAT I WOULD SAY A REMARKABLE CONVERGENCE AROUND A SERIES OF RECOMMENDATIONS WHICH WE'RE PRESENTING TO YOU TODAY. THIS IS CALLED AN INTERIM REPORT BECAUSE THERE'S LARGER SCOPE AND DISCUSSIONS TO HAVE BUT FELT IT WAS IMPORTANT ENOUGH ENTHUSIASM AROUND THESE RECOMMENDATIONS TO PRESENT TO YOU TODAY TWO TO THREE MONTHS AFTER OUR FACE TO FACE ON THE BOTTOM OF THE SLIDE ARE NICKNAMES FOR THE FOUR RECOMMENDATION WE'LL GO THROUGH. THOSE CIRCLES ARE THE DIFFERENT NUMBER OF DIFFERENT TELECONFERENCES HELD BETWEEN SUBGROUPS TO CONVERGE ON THE RECOMMENDATIONS NOW GOING TO PRESENT. THE WAY WE'LL DO THIS IS -- NEXT SLIDE IS THE SHORT HAND FOR THE FOUR RECOMMENDATIONS. I WILL DISCUSS THE FIRST ONE THEN WILL HAND OFF TO MIA TO PRESENT THE NEXT THREE. AGAIN, I REFER YOU TO THE PDF YOU RECEIVED BY EMAIL IF YOU WANT TO TWO TO THREE PAGER ABOUT EACH WHICH IS ORGANIZED IN A FORMAT WHERE YOU CAN GET THE RATIONALE AND QUICKLY TOGGLE DOWN TO THE SPECIFIC RECOMMENDATIONS SO LET ME MOVE ON ON TO THE FIRST RECOMMENDATION, WHICH IS THE NEXT SLIDE. SO WE GAVE THIS VARIOUS NAMES AMONG US WE CALL IT THE LEAP FROG RECOMMENDATION. WE HAVE ALSO CALLED IT THE QUICK WIN. AND THE BASIC IDEA HERE THAT REALLY CAME TO THE SURFACE QUICKLY AND WAS IN PART SUGGESTED BY NED, AND IDEAS HE HAD WAS TO TAKE ADVANTAGE OF HIGH VALUE DATA SETS EXISTS TODAY WHICH ONE SENSE INCOMPLETE OR LACK RESOURCES TO MAKE THEM HARMONIZED AND SHAREABLE. AROUND THE TABLE THIS WAS EBB DOERED IMMEDIATELY, THERE'S EXAMPLES PRESENTED OF DATA SETS THAT MIGHT QUALIFY. SO LET ME JUST GIVE YOU A LITTLE MORE COLOR HERE. ONE BURNING QUESTION AFTER TCGA IS HOW WE LINK GENOMIC BIOMARKERS WITH OUTCOME. TCGA IS PRY MAY HAVE TUMORS, AMOUNT OF CLINICAL DATA THAT'S ATTACHED INITIALLY WAS QUITE LOW THOUGH THERE'S MORE SURVIVAL DATA BEING GENERATED. THIS IS ALSO PRIMARIES WITHOUT PRIOR TREATMENT AND DON'T REFLECT THE FULL UNIVERSE OF CANCERS TREATED CLINICALLY, METASTATIC DISEASE, PRIOR THERAPY, JUST LIKE WE HEARD ABOUT. JUST NOW. AS WELL AS IN COMMUNITY PRACTICES AND SO FORTH. SO ONE VERSION OF THIS WOULD BE TO START OVER AND GENERATE LARGE COHORTS. WITH EXPLOSIVE GROWTH OF CLINICAL SEQUENCING A LOT OF FRONT HAVE OF THIS IS ESSENTIALLY AVAILABLE ON THE TABL AND THE QUESTION WAS HOW COULD WE CAPITALIZE ON THIS. ON THE ONE SIDE, GENOMICLY ANNOTATED PATIENT COHORTS FOR WHICH THERE'S NOT COMPREHENSIVE CLINICAL DATA. EXISTS BUT NOT EXTRACTED FROM MEDICAL RECORDS. THE FLIP SIDE, ARE CLINICAL TRIALS COHORTS, WELL ANNOTATED CLINICALLY WHICH BIOSPECIMEN BANKS MIGHT HAVE BEEN GENERATED BUT GENOMIC DATA FOR SUCH COHORTS IS NOT YET GENERATED. WE IMAGINED AND THINK OF EXAMPLES ON BOTH SIDES THAT COULD BENEFIT FROM SUPPORT TO COMPLETE THE HOLE. ANOTHER PART OF THIS, THERE ARE DATA SETS WHICH ARE MOORE OR LESS COMPLETE BUT LACK RESOURCES THEM EFFICIENTLY IN THE CANCER RESEARCH DATA COMMONS. SO AGAIN, I REFER YOU FOR MORE DETAILS TO THE RIGHT BUT THE RECOMMENDATION HERE IS THE NCI CONSIDER WAYS TO GET QUICK WINS BY CREATING AN RFP WHICH WE WOULD IMAGINE GROUPS WOULD SUBMIT QUALITY AND VALUE OF A DATA SET AND ASK FOR ADDITIONAL FUNDS TO COMPLETE IT. AND OF COURSE DEFEND THE FEASIBILITY AND SO FORTH. SO I THINK I WILL STOP THERE. ENCOURAGE YOU TO ASK QUESTIONS AT THE END ABOUT EACH RECOMMENDATION AND PASS THE MIC TO MICSA. >> THANK YOU -- MIA. >> THANK YOU. CAN YOU HEAR ME? >> I CAN. >> OKAY. SO CHARLES, THANK YOU SO MUCH FOR SETTING UP THE PROCESS OF THE COMMITTEE AND OUR PROGRESS TO DATE. AND THANK YOU AGAIN TO NED FOR THE OPPORTUNITY TO BRING THIS GROUP OF VERY ENTHUSIASTIC PEOPLE TOGETHER THE TALK ABOUT THE FUTURE OF DATA SCIENCE AND HOW NCI CAN FACILITATE THAT. OUR SECOND RECOMMENDATION FOLLOWS VERY NICELY ON FROM THE INTRODUCTION CHARLES GAVE REGARDING THE LEAP FROG PROJECT WHERE IS. BECAUSE AS WE ALL KNOW WHEN WE COLLECT DATA FOR ROUTINE CLINICAL CARE, IT IS VERY DIFFERENT WORK FLOW AND VERY DIFFERENT PROCESS THAN THE WAY WHICH WE COLLECT DATA FOR RESEARCH PURPOSES. OUR SECOND RECOMMENDATION IS TO LOOK TOWARDS HARMONIZING TERMINOLOGIES BETWEEN CANCER RESEARCH AND CLINICAL CARE WITH THE GOAL OF BEING ABLE TO ACHIEVE NEAR CLINICAL TRIAL GRADE DATA WITHIN TRADITIONAL CLINICAL CARE SETTINGS. WE UNDERSTAND THAT AS A VERY BIG VISION BUT AS WE ALL KNOW WHEN WE HAVE THESE VERY LARGE DATA SETS OF GENOMICS AND YOU GO TRY TO GET CLINICAL DATA OUT, SO MUCH HAS TO BE MANUALLY EXTRACTED IN ORDER TO BE USEFUL FOR DOWNSTREAM PURPOSES. OUR VISION IS TO FLIP THAT AROUND AND BEGIN TO EVALUATE WAYS WHICH THE ELECTRONIC HEALTH RECORD COULD BE USED TO COLLECT DATA UP FRONT AND THUS MAKING IT A SEAMLESS PROCESS FOR SECONDARY USE DOWNSTREAM FOR RESEARCH PURPOSES. THERE'S LOW HANGING FRUIT IN ALL THIS. REPRESENTED BY ICONS OF CLINICAL TERMINOLOGIES AND DATA STANDARDS SHOWN ON THIS SCREEN. WE HAVE FOUND SEVERAL EXISTING STANDARDS AND TERMINOLOGIES THAT ARE WIDELY USED WITHIN ELECTRONIC HEALTH RECORDS SUCH AS DRUGS OR SNOMED FOR DIAGNOSES, BUT STILL HAVE SIGNIFICANT GAPS WITH RESPECT TO COVERAGE AND DEPTH OF CANCER TERM NOL SPACE ESPECIALLY AS IT RELATES TO RESEARCH. SO TAKE RX NORM FORM EXAMPLE, IT HAS WONDERFUL TERMINOLOGY FOR DRUGS MANY CLINICAL CENTERS ARE NOW USING FOR THEIR PHARMACY INFORMATION SYSTEMS DISPENSING MEDICATIONS BUT IT LAX REPRESENTATION OF -- LACKS REPRESENTATION OF INVESTIGATIONAL THERAPEUTICS. THE NCI THESAURUS HAS A WONDERFUL REPRESENTATION OF EXPERIMENTAL THERAPEUTICS SO THE CLINICAL RESEARCH CENTERS TAKE CARING OF PATIENT AND USING ELECTRONIC HEALTH RECORD FOR RESEARCH, THEY ARE REPRESENTING THOSE DRUG TERMINOLOGIES IN DIFFERENT WAYS SO COULD WE PROPOSE SPECIFIC SET OF PROJECTS AROUND LEVERAGING EXISTING DATA STANDARDS AND GROUPS THAT ALREADY ARE WELL ACCOMPLISHED AND UTILIZED -- ESTABLISHED AND UTILIZED BY THE CLINICAL INFORMATICS COMMUNITY INSIDE THE ELECTRONIC HEALTH RECORD AND ENABLE THEM STRONGER FOR PURPOSES OF CANCER RESEARCH COMMUNITY. THERE'S SIGNIFICANT NUMBER OF BENEFITS TO THIS, INCLUDING INCREASING EASE OF INCORPORATION AND CLINICAL CARE FROM EHR INTO CLINICAL RESEARCH AND ENABLING BETTER PATIENT CARE AND REAL WORLD EVIDENCE GENERATION. IF WE'RE GOING TO START USING CARE OF ALL PATIENTS IN OUR CANCER COMMUNITIES, TO INFORM THE CARE OF THE PATIENTS GOING TO COME TOGETHER WE NEED TO SOLVE THIS PROBLEM, IT'S A BIG ONE BUT THERE ARE STEPS, THERE ARE DISCRETE STEPS WE CAN TAKE TO GET THERE ALONG THAT PATH. BUT THIS ALSO WILL HELP ENHANCE INTEGRATION OF CANCER AND NON-CANCER RESEARCH COMMUNITIES. BY MAKING CANCER DATA MORE ACCESSIBLE TO NON-CANCER RESEARCH IMMUNITIES FOR -- COMMUNITIES FOR SYNERGISTIC RESEARCH. OUR THIRD RECOMMENDATION AIMS TO ADDRESS CHALLENGES WE HAVE IN THE WORK FORCE OUR LACK OF SUFFICIENTLY NUMBER OF TRAINED DATA SCIENTISTS, SPECIFIC HI THOSE WHO HAVE A FOCUS ON CANCER RESEARCH AND CARE. SO WE ARE RECOMMENDING STEPS TO INCREASE THE NUMBER OF TRAINING PROGRAMS AND TRAINEES IN CANCER DATA SCIENCE AND SOME VERY SPECIFIC RECOMMENDATIONS INCLUDE THE CREATION OF A DEDICATED SPECIFIC T-32 TRAINING PROGRAM IN CANCER DATA SCIENCE AS WELL AS OPPORTUNITIES FOR THE NCI TO CONTRIBUTE TO EXISTING NIH TRAINING PROGRAMS SUCH AS THE NATIONAL LIBRARY OF MEDICINE, T-15 TRAINING PROGRAMS AND BIOMEDICAL INFORMATICS DISTRIBUTED ACROSS THE COUNTRY AS WELL AS THE NIGMS MEDICAL SCIENCE TRAINING PROGRAMS. FOR MD Ph.D.s. FURTHERMORE WE RECOMMEND DEVELOPING A SHORT TERM TRAINING PROGRAM FOR CLINICIANS AND BIOLOGICAL SCIENCES. SCIENTISTS WITH THE GOAL OF PROVIDING THEM THE NEEDED FOUNDATIONAL UNDERSTANDING FOR CANCER -- FOR THESE CANCER RESEARCHERS TO BE ABLE TO COLLABORATE WITH THE INFORMATICIANS IN ORDER TO LEVERAGE DATA. WE BELIEVE THESE CROSS TRAINING PROGRAMS CREATE GROWTH OPPORTUNITIES INSIDE AND OUTSIDE OF ACADEMIA. THIS PARTICULAR GROUP, THIS SUBGROUP MEMBERS WHOM YOU SEE ON THE RIGHT THEY HAD A NUMBER OF OTHER RECOMMENDATIONS THEY ARE PREPARED TO PUT TOGETHER SO AS CHARLES ALLUDED TO, THIS IS JUST AN INTERIM REPORT BY OUR WORKING GROUPS AND WE ARE PLANNING ON CONTINUING TO EVOLVE THIS PARTICULAR RECOMMENDATION TO INCLUDE OTHER POST-DOC TRAINING PROGRAMS AS WELL. IN NEAR TERM. MORE TO COME IN THIS CATEGORY. AS WE MOVE FORWARD. OUR FINAL RECOMMENDATION IS TO SPONSOR A SERIES OF DATA SCIENCE CHALLENGES. WHEN WE THINK ABOUT CHALLENGES THIS IS THE OPPORTUNITY FOR DATA TO BE PUT OUT IN THE PUBLIC DOMAIN AND COMPUTATIONAL SCIENTISTS TO COME IN AND MANIPULATE THAT DATA TO ACHIEVE SOME TYPE OF TASK OR GOAL. IT SERVES MULTIPLE GOALS AT THE SAME TIME. THE FIRST IDEA WAS THAT THERE COULD BE FOUR TO EIGHT CHALLENGE TOPICS PER YEAR THAT COULD BE PUT FORTH AND HERE IS LISTED JUST SAMPLING OF TOPICS THAT THE COMMITTEE CAME UP WITH INCLUDING ALGORITHMS TO DO DRUG RESPONSE PREDICTION, DISCOVERY OF MULTI-OMICS PROGNOSTIC MARKERS, DECONVOLUTION OF HETEROGENEOUS TUMORS, ALGORITHMS TO CREATE DIAGNOSES, GRADING AND STAGING AND DATA ACCESS AND INTEGRATION FROM THE CLINICAL ETHICAL AND SOCIOLOGICAL STAND POINT. WHEN WE RECOMMEND ALL GREAT SUGGESTIONS WE RECOMMEND AS FIRST STEP CONSIDERING BEGINNING WITH AN IDEA CHALLENGE TO ASK THE COMMUNITY TO IDENTIFY APPROPRIATE CHALLENGES AND TASKS THAT THEY THINK WOULD BE FEASIBLE FOR MULTIPLE SCIENCES TO COME TOGETHER TO TRY TO SOLVE. WE LIST A COUPLE OF EXAMPLES OF TYPES OF CHALLENGES AND PRIZES THAT HAVE COME BEFORE THIS. THERE'S MANY ADVANTAGES TO DOING DATA SCIENCE CHALLENGE, INCLUDING IT SPURS RESEARCH AND COMMUTATIONAL -- COMPUTATIONAL AND INCREASES AVAILABILITY OF ADVANCED SOFTWARE TO THE BROADER RESEARCH COMMUNITY BY DEMONSTRATING UTILITY ON THESE DATA SETS AND REALLY HAVING THEM COMPETE AGAINST ONE ANOTHER TO SHOWY IS TRULY PERFORMING THE BEST. IT SERVES TO ATTRACT NEW TALENT TO CANCER RESEARCH COMMUNITY FROM OUTSIDE FIELDS THAT DON'T APPLY FOR NCI GRANTS OR CONTRACTS. FURTHERMORE ALLOWS THESE TOOLS TO BE VALIDATED IN A CONTROLLED ENVIRONMENT AS WELL AS DISSEMINATE FURTHER, SO STATE-OF-THE-ART TOOLS ADOPTED MORE BROADLY. WE THINK THESE DATA SCIENCE CHALLENGES IN THE END REFLECT A CULMINATION OF THE THREE PREVIOUS RECOMMENDATIONS BY THIS WORKING GROUP. THEY LEVERAGE OPENLY SHARED DATA SETS WHICH WE NEED TO CONTINUE TO SUPPORT THROUGH RESOURCES IN ORDER THE MAKE THOSE DATA SETS MORE COMPLETE AND ACCESSIBLE TO THE COMMUNITY IT SHOWS HOW DATA SETS NEED TO BE HARMONIZED ACROSS ONE ANOTHER AND GIVES NEW OPPORTUNITIES FOR PARTICIPANTS TO ENHANCE SKILLS AND EXPERTISE AN DEMONSTRATE UTILITY OF THE APPLICATIONS THEY ARE CREATING. WE ARE INCREDIBLY EXCITED HOW IN SUCH A VERY SHORT PERIOD OF TIME OUR WORKING GROUPS WERE ABLE TO COME TOGETHER TO BRING THESE RECOMMENDATIONS TO THE NCAB TODAY. WE APPRECIATE YOUR TIME AND LISTENING AND CHARLES AND I ARE HAPPY TO TAKE YOUR QUESTIONS. >> THANK YOU, MEA AND CHARLES. TERRIFIC PRESENTATIONS. QUESTIONS FOR EITHER ONE OF THEM? >> CAN YOU HEAR ME? >> YES. >> HELLO, EVERYBODY. THANK YOU, THAT WAS REALLY A GREAT PRESENTATION AND I'M EXCITED BY THE WORK GROUP AND THE CHALLENGES. SO I JUST HAVE A COUPLE OF QUESTIONS. I HAVE YOUR REPORT HERE THAT I'M LOOKING AT. YOU FOCUSED ON MERGING GENOMIC TREATMENT AND CLINICAL OUTCOMES DATA. SO I WOULD SUGGEST YOU ALSO THINK ABOUT PATIENT REPORTED DATA ALSO BEING MERGED WITH THAT OUTCOMES AND PATIENT REPORTED DATA. SO I'LL GIVE AN EXAMPLE WHAT I AM GETTING AT. WE FUND A PILOT STUDY IN THE ALLIANCE FOR CLINICAL TRIALS, THAT'S A COOPERATIVE GROUP FOR THOSE THAT DON'T KNOW ABOUT ALLIANCE. WE HAD AN INVESTIGATOR WHO WANTED TO LOOK AT SEVEN LUNG TREATMENT PROTOCOLS TO SEE IF SHE CAN DO DATA HARMONIZATION WITH THE SMOKING VARIABLES. LOW AND BEHOLD THREE OF THE SEVEN LUNG CANCER TREATMENT TRIALS COLLECTED INFORMATION ON SMOKING STATUS. AS WELL AS DETAILED INFORMATION ON SMOKING. YES WE KNOW SMOKING CAUSES LUNG CANCER BUT WE ALSO KNOW THAT SMOKING IMPACTS PROGNOSIS AND OUTCOME, NOT ONLY LUNG PATIENTS BUT OTHER PATIENT WHO WERE TREATED. I THINK THAT WE'RE MISSING A VERY IMPORTANT OPPORTUNITY NOT TO INCLUDE SOME DEMOGRAPHIC EPI YOU COME DATA AS WELL AS PATIENT REPORTED OUTCOMES. AS WE'RE LOOKING AT HOW WE CAPTURE DATA. AND ESPECIALLY IN THE CLINICAL TRIALS GROUPS WE HAVE A LOT OF THIS BIG DATA ESPECIALLY IN RELATION TO PATIENT REPORTED OUTCOME. IT'S ALSO IMPORTANT LOOKING AT CELLS, GENETIC MUTATIONS WE NEED TO BRING IN OTHER THINGS THAT THAT ARE HE WILL EVENTUAL TO THE POPULATION. FOR EXAMPLE, RACE. SO I REALLY LOVE THE LAST PRESENTATION ON PEDIATRIC ONCOLOGY, SO NICE TO SEE HETEROGENEITY OF THE TUMORS. IF WE MOVE UP A LEVEL IN TERMS OF THINKING FOR THE WHOLE PERSON WERE THERE DIFFERENCES BY RACE, THINGS LIKE THAT, I UNDERSTAND WE HAVE ISSUES SELF-REPORTED RACE AND ANCESTRAL FORMATIVE MARKERS BUT I THINK THIS IS A HUGE OPPORTUNITY TO BRING EVEN MORE OF THESE VARIABLES IN. SO THANK YOU FOR LISTENING. >> DID YOU WANT TO RESPOND, CHARLES? OR MIA? WE CAN'T HEAR YOU, CHARLES. STILL CAN'T HEAR YOU. >> NOW CAN YOU HEAR ME? >> YES. >> ELECTRA, THANKS FOR THE QUESTION, WE DIDN'T LIST EVERY POSSIBLE DATA ELEMENTS IN THIS SHORT PRESENTATION AND OF COURSE WE ARE AWARE OF PATIENT REPORTED OUTCOME DATA SETS. THE WAY WE ENVISION AT THE NCI DECIDES TO ACT ON THIS T IS THAT APPLICANTS IN SOME LETTER OF INTENT FORMAT MIGHT SUBMIT TYPES OF DATA THAT THEY HAVE ALREADY COLLECTED FOR WHICH ADDITIONAL SEWERS OF FUNDS COULD HELP COMPLETE THEM. IF THERE ARE EXAMPLES, AS YOU MENTIONED OF PRO DATA SETS THAT COULD BE JUSTIFIABLY ENHANCED BY ADDING WHATEVER MISSING ELEMENT WE WOULD SUGGEST IT THAT WAY, RATHER THAN TRY TO PRESCRIBE IN ADVANCE EXACTLY WHAT DATA ELEMENTS SHOULD BE PART OF EVERY DATA SET. OOHED THING WE SHOULD MENTION, IT WAS NOT READY TO PRESENT TO THE GROUP, WE DISCUSSED SOMETHING WE CALL A LANDSCAPE ANALYSIS T. WHICH SHOULD BE TRYING TO SURVEY HIGH VALUE DATA SETS THAT MIGHT FIT INTO THIS RECOMMENDATION ONE TYPE FORMAT. WHAT YOU MENTIONED ARE ONES THAT MIGHT HAVE BEEN MENTIONED AROUND THE TABLE BUT DIDN'T MAKE IT INTO THE FINAL SLIDES. >> OTHER QUESTIONS? TERRIFIC. DO YOU HAVE A TIME LINE WHEN YOU HAVE A FINALIZED REPORT? >> GREAT QUESTION. WE GOT SO EXCITED AROUND THESE INITIAL ONES WE WANTED TO JUST GET THEM TO YOU. OUR NEXT COMMITTEE MEETING IS IN SEPTEMBER. WE ARE GOING TO TRY TO COMPLETE -- HAVE A LARGER BROADER DISCUSSION, THIS LANDSCAPE STUDY WOULD PROBABLY BE THE NEXT ITEM. WE ARE HAPPY TO TAKE SUGGESTIONS FROM OTHERS AS TO HOW -- WHEN DOES A COMPLETE REPORT NEED TO BE DONE, WHAT IS YOUR DEFINITION OF COMPLETE. OBVIOUSLY DATA SCIENCE CAN GET WELL BEYOND WHAT IS REALLY IN SCOPE JUST FOR NCI VERSUS COLLABORATIONS WITH MULTIPLE OTHER GROUPS AND AGENCIES. MAYBE NED CAN GIVE A LITTLE BEAR SPECKTIVE. >> WE TALKED -- PERSPECTIVE. >> WE TALKED ABOUT THIS EARLIER. I DOUBT THIS REPORT WILL BE SO MUCH AS FINISHED AS ABANDONED. SOME POINT WE HAVE TO -- I'M FULLY AWARE THAT WE WILL NEVER FEEL COMPLETELY DONE AND THERE WILL BE OTHER TOPICS WE WISH TO TAKE UP. MAY WANT TO DISCUSS FURTHER. AS I TOLD THE GROUP EARLIER IT WILL BE FINE IF YOU WANT INITIAL REPORT AND UPDATE AS TOPICS ALLOW OR REQUIRED. BUT I THINK GIVEN THE TIMING RELATED TO THE C BIT SEARCH, HAVING A SOMEWHAT INITIAL SET OF RECOMMENDATIONS THAT CAN BE APPROVED AND ACTED UPON, MAYBE IN THE NEXT THREE TO SIX MONTHS WOULD BE GOOD. AT THAT POINT NOT TO SAY IT'S FINISHED OR DONE, LAST WORKING GROUP EVER DO BUT THAT WOULD BE VERY USEFUL FOR THE NCI AS WE STARTS BRING IN NEW LEADERSHIP IN THIS AREA AND ALSO START TALKING 2019 PLANS. I THINK IT IS LIKELY IMPOSSIBLE THERE WILL BE SOME ITEMS YOU ARE THINKING NOW YOU CANNOT DO IN THAT TIME FRAME BUT LOOKS LIKE YOU'RE OFF TO AN EXCELLENT START IN THESE AREAS. SO REPORT ON THESE AREAS PLUS PERHAPS ANY THINGS ALREADY INCUBATING IN A SHORTER TIME FRAME WOULD BE VERY HELPFUL. >> OKAY. >> VERY GOOD DIRECTION. THANK YOU. >> ONE OTHER THING BY THE WAY. I WANT TO THANK MIA AND CHARLES FOR DOING THIS. I WAS IMPRESSED BY THE LEVEL OF ENTHUSIASM AND GUNNING HO SPIRIT OF THIS WORKING GROUP. I THINK IT WAS A REALLY MARVELOUS ENERGY WHEN I TALKED TO THEM, YOU CAN SEE OFF TO A GREAT START AND IT'S -- I WAS WORRIED WE HAD A WIDE DIVERSITY OF THOUGHT THAT THEY WOULDN'T AGREE ON ANYTHING BUT CLEARLY THEY REACHED REAL REMARKABLE CONSENSUS QUICKLY BECAUSE THERE ARE SOME THINGS NCI NEEDS TO DO IN THIS PROCESS BROUGHT INTO SHARP RELIEF. THANK YOU FOR THE HELP AND GREAT LEADERSHIP. >> ANY OTHER QUESTIONS OR COMMENTS? WE WERE GOING TO TAKE A VOTE TO ACCEPT THE INTERIM REPORT IN CASE THERE IS AVAILABILITY FOR IMPLEMENTING BEFORE YOU COME BACK TO US IN THE FUTURE. WITH THAT SAID I WOULD LIKE TO ASK FOR A MOTION TO ACCEPT. >> SO MOVED. >> SECOND. THANK YOU. ALL THOSE IN FAVOR RAISE YOUR HANDS. ANY AGAINST? ANY ABSTENTIONS? OKAY. THE MOTION IS APPROVED. THANK YOU BOTH VERY MUCH. THAT WAS TERRIFIC. AND THE FINAL PRESENTATION WILL BE ON THE AD HOC GLOBAL HEALTH WORKING GROUP AND PRESENTERS WILL BE DEB BRUNER AND NELL HODGESON. I'M SORRY. I'M LOOKING AT THE WRONG -- DEB BRUNER AND DR. GOPAL. >> IS DR. GOPAL WITH US? CAN YOU HEAR US? >> CAN YOU HEAR ME? >> YES. >> SO I'M HAPPY TO PRESENT ON BEHALF OF DR. GOPAL AND OUR AD HOC WORKING GROUP. DO I HAVE CONTROL NOW? NEXT SLIDE PLEASE. OUR WORKING GROUP LISTED HERE. AND ALSO OUR EX-OFFICIO MEMBERS WHO PRESENTED DATA TO THE GROUP THAT WAS VITAL TO OUR RECOMMENDATIONS THE CHARGE TO THE GROUP FROM DR. SHARPLESS IS WE ADVICE AND HAVE DIRECTOR OF ACCOMPLISHMENTS AND OPERATIONS OF THE NCI CENTER FOR GLOBAL HEALTH AND WE FOCUS ON THE MISSION PRIORITIZATION PROCESS GOALS AND SCIENTIFIC ACTIVITIES OF THE CENTER. NEXT SLIDE PLEASE. WE REVIEWED COPIOUS AMOUNTS OF MATERIAL AND HAD EXCELLENT THOUGHTFUL PRESENTATIONS BY DR. TRIMBLE OF THE CURRENT STATUS AND PAST ACHIEVEMENTS OF THE CENTER. AND ON AN INTERNAL REVIEW THAT DR.S CROYLE AND CHUCK HAD LED AT THE NCI OF THE CENTER. THEY INTERVIEWED TED AND NUMEROUS STAFF TO FURTHER DELVE INTO THE MISSION GOALS AND PRIORITIES. NEXT SLIDE, PLEASE. WE WERE IMPRESSIOND WITH THE FRAMEWORK LIST HERE. IT INCLUDES GLOBAL ONCOLOGY RESEARCH, ALSO INCLUDES SURVEILLANCE OF ONGOING RESEARCH, TRAINING, HEALTH DIPLOMACY AND AT THIS SEMINATION. HOWEVER, WHAT WE FOUND IS THAT THERE SEEMED TO BE NOT FOCUSED ON THE AMOUNT OF TIME AND RESOURCES THAT WENT TO THAT CENTER GLOBAL RESEARCH AREA OF FOCUS. NEXT SLIDE PLEASE. NEXT PLEASE. SO THE GROUP HAD FIVE BASIC RECOMMENDATIONS. YOU HAVE THE FULL REPORT SIMPLIFY, FIRST IS CLARIFICATION OF THE MISSION STATEMENT AND GOALS. THE MISSION STATEMENT SHOULD APPROPRIATELY INCLUDE GLOBAL ONCOLOGY RESEARCH OF COURSE BUT WITH A MORE CLEAR PRIMARY FOCUS, AND REST OF THE MISSION SHOULD BE FILTERED THROUGH THAT PRIMARY MISSION INCLUDING THOSE AREAS WE MENTION SURVEILLANCE TRAINING DISSEMINATION AND PARTICULARLY DIPLOMACY WHICH SEEMS TO BE TAKING GROWING AMENT OF RESOURCES AND TIME OF THE SENTENCER STAFF. MISSION SHOULD SPECIFICALLY ADDRESS AND IT CURRENTLY DOES NOT, VULNERABLE POPULATIONS AND HEALTH DISPARITIES. BY DEFAULT THERE'S A GREAT DEAL OF PORTFOLIO IN THAT AREA BUT THE MISSION ITSELF DOES NOT SPECIFY THIS IS THE MISSION AND GOAL OF THE CENTER. THE RESEARCH FOCUS SHOULD INCLUDE SPECIFIC SCIENTIFIC UNIQUE OPPORTUNITIES IN THE LOW MIDDLE INCOME COUNTRIES AND THAT IN PARTICULAR THE GROUP THOUGHT WAS THE INTERSECTION OF INFECTIOUS DISEASE AND CANCER. TRAINING AND CAPACITY BUILDING SHOULD BE EMBEDDED IN ALL RESEARCH INITIATIVES, WITH THE VIEW TOWARDS SUSTAINABILITY. AND WHILE AGAIN THAT'S INCORPORATED IN SOME, THERE'S NOT A UNIQUE ARTICULATION OF THAT GOAL IN THE MISSION. THE CENTER SHOULD MOST CERTAINLY HAVE GRANT MAKING AUTHORITY. AND THERE NEEDS TO BE A STRATEGIC THINKING AS I MENTIONED BRIEFLY ON THE FOCUS OF RESEARCH VERSUS DIPLOMACY. DIPLOMACY IS A KEY ACTIVITY OF THE CENTER. HOWEVER, IT SHOULD BE DRIVEN BY IN SEPARATE OFFICE UNDER THE GLOBAL CENTER FOR HEALTH, WITH SPECIFIC STAFF FOCUSED ON DIPLOMACY AND CLEAR UNDERSTANDING HOW MUCH RESOURCES GO INTO THAT. THE HEALTH CENTER MAY WANT MISSION STATEMENTS FROM SUCCESSFUL GLOBAL HEALTH PROGRAMSND AND THERE'S IN FROM MODEL THAT HELP ARTICULATE THE PRIORITIES. NEXT SLIDE PLEASE. >> ARE YOU SEEING IT AND I'M NOT? >> WE SEE IT. THANK YOU. NOW I SEE IT. THE SECOND RECOMMENDATION SURROUNDS ENHANCED COORDINATION AND COMMUNICATION WITHIN AND ACROSS THE NCI AND NIH. WE SUGGEST THAT THE MISSION NEEDS TO BE CLARIFIED IN ALIGNED WITH THE RESOURCES AND GOALS COMMUNICATION SHOULD BE CLEAR THROUGHOUT THE CENTER SO THAT ALL STAFF UNDERSTAND AND ARTICULATE THE MISSION. IN THE INTERNAL REVIEWS THERE WAS LACK OF CLARITY BY STAFF ON UNDERSTANDING COMMON MISSION AN GOALS. A PROCESS IS NEEDED TO BETTER GLOBAL HEALTH CENTER WITH OTHER- NIH INSTITUTES. WE WERE IMPRESSED BY HOW THE CENTER HAS BROUGHT TOGETHER DISPARATE ACTIVITIES ACROSS THE NIH INTO THIS ONE CENTER WHICH WAS A MUCH NEEDED ACTIVITY. BUT NOW AS THE CENTER HAS BEGUN TO REALLY FORMULATE ITS MISSION, IT NEEDS CONTINUED BETTER INTEGRATION ACROSS THE OTHER NIH SIFT ACTIVITIES AND GLOBAL TOUCHESES SO MANY OTHER DEPARTMENTS AND ACTIVITIES THAT GO ON AT THE NIH. BETTER COORDINATION OF RESEARCH ACTIVITIES WITH FOGARTY INTERNATIONAL T GIVEN WE HAVE A LONG HISTORY IN THIS PARTNERSHIP AND IT HELPS TO LEVERAGE EARLY CAREER DEVELOPMENT SUPPORT FOR LOW AND MIDDLE INCOME GLOBAL HEALTH LEADERS. NEXT SLIDE PLEASE. THE THIRD RECOMMENDATION WAS AROUND CLEAR PROCESS FOR PRIORITY SETTING. THE CERTAINTIER NEEDS TO ALIGN PRIORITIESES WITH THE REST OF THE NIH MISSION AND PRIORITIES. PRIORITIES SHOULD HAVE CLEAR CRITERIA, WE INCLUDE FOR CONSIDERATION THE FOLLOWING. THE BURDEN OF CANCER IN ANY GIVEN COUNTRY. THE CURRENT HUMAN AND INFRASTRUCTURE CAPACITY WE BELIEVE THIS IS KEY BEFORE THE NIH DETERMINES MAKING AN INVESTMENT IN ANY COUNTRY OR WITH A PARTNER. THE CRITICAL MASS OF CANCER CENTER INVOLVEMENT FOR LEVERAGE WOULD BE A KEY METRIC TO CONSIDER WHEN DECIDING ON WHERE WE SHOULD PUT OUR RESOURCES. ANY GOVERNMENT PARTNER WE DECIDE TO PARTNER WITH, WE SHOULD LOOK AT THE GOVERNMENTAL STRUCTURES AND THE GOVERNMENT COMMITMENT ALSO THINGS LIKE CORRUPTION AND OTHER ISSUES OR CHALLENGES WE NEED TO BE CRITICALLY AWARE OF BEFORE WE DECIDE TO >> IN AND COMMIT RESOURCES TO ANY GIVEN COUNTRY. I FOR SUSTAINABILITY MENTIONED MULTIPLE TIMES, THAT WILL SHOULDN'T ONE OF THE ISSUES AND CONSIDERING WHERE TO SET PRIORITIES AND WHAT COUNTRIESES TO PARTNER WITH. THERE ARE MULTIPLE FRAMEWORKS THAT TESTIMONY CENTER CAN FOR -- THAT THE CENTER CAN CONSIDER. THE I OBJECTIONM HAS VERY IMPORTANT REPORT THAT CAME OUT AFTER EBOLA WITH THESE CONSIDERATION IT IS FOR PRIORITY SETTING THAT SHOULD BE CONSIDERED. WHAT IS NOT BEEN CLEARLY ARTICULATED IN THE PAST ARE METRICS OF SUCCESS. SO THERE ARE MANY MULTIPLE METRICS THAT CAN BE CONSIDERED, AGAIN, BACK TO IOM FRAMEWORK, THERE'S SOME MENTION THERE. T BUT SUSTAINABILITY SHOULD ALSO BE ONE OF THE KEY METRICS. NEXT SLIDE PLEASE. FOURTH RECOMMENDATION. CENTERS AROUND EXTERNAL ADVISORY BOARD, EXTERNAL TO THE CENTER AND INTERNAL TO NIH OR EXTERNAL TO NIH, WITH ACTIVE INVESTIGATORS AROUND THE COUNTRY. THEY NEED TO MEET TO LOOK AT PRIORITIZATION OF NEW RESEARCH DEPLOY MACY ACTIVITIES AND AGAIN -- DIPLOMACY ACTIVITIES AND SCOPE AND AMOUNT. AND OTHER ACTIVITIES INCLUDED BUT ALSO WITH AN EYE TO THESE EVALUATION METRICS. THEN THE FIFTH AND LAST RECOMMENDATION T NEXT SLIDE PLEASE. IS TO ESTABLISH BETTER LINKAGE WITH THE CANCER CENTERS. THERE HAVE BEEN SUPPLEMENTS THAT& GO OUT, USUALLY SMALL AND FOR VERY SHORT TIME FRAME OFTEN ONE TO TWO YEARS. GIVEN CHALLENGES OF WORK IN LOW AND MIDDLE INCOME COUNTRIES THE RECOMMENDATION IS TO CONSIDER BETTER SUPPORT FOR GLOBAL HEALTH ACTIVITIES IN CANCER CENTER WITH LARGER FUNDING OPPORTUNITIES AND CLEARER LONG TERM GOALS THAT MAKE SENSE. WE OFFERED THE CONSIDERATION OF GLOBAL ONCOLOGY SPORES. GIVEN TO CANCER CENTERS OR SOME ANALOGOUS COMPARATIVE OPPORTUNITIES. CANCER CENTERS SHOULD PLAY A LARGER ROLE IN CAPACITY BUILDING, IT BUILDS INTO GRANTS AND SUPPLEMENTS AND COORDINATION OF THE CENTERS FUNCTION WITH CANCER CENTERS IN TERMS OF REGULAR MEETINGS THAT BRING TOGETHER THOSE CENTERS THAT ARE INTERESTING AND HAVE CAPACITY FOR GLOBAL HEALTH WOULD BE HELPFUL. THAT'S OUR PRESENTATION. DR. GOPAL AND I ARE APPRECIATE ANY FEEDBACK, COMMENTS OR QUESTIONS. >> THANK YOU, SATESH, DID YOU WANT TO ADD ANYTHING? >> I THINK THAT WAS AN EFFECTIVE SUMMARY AND REPRESENTED IT PRETTY HIGH DEGREE OF SENSE AMONG THE WORKING GROUP MEMBERS, I THINK. >> THANK YOU, BOTH. QUESTIONS? FOR EITHER ONE? FROM THE GROUP? THANK YOU FOR THAT SUMMARY. >> ONE REMARK. I WOULD LIKE TO THANK THIS WORKING GROUP COMING TOGETHER QUICKLY AND WRAPPING THEIR ARMS AROUND A LARGE COMPLEX SET OF ACTIVITY IT IS NCI HAS ONGOING AND HAS BEEN IMPRESSIVE TO ME HOW ORGANIZED AND CLEAR THINKING THIS COMMITTEE HAS BEEN. I THANK DEB AND SATEESH FOR THEIR LEADERSHIP. THERE'S A MAJOR DEVELOPMENT AS WE CONVENED THE WORKING GROUP, AT THE LAST NCAB AND B SECOND QUARTERA JOINT MEETING, -- BSA JOINT MEETING, TED TRIMBLE TOOK ON A LIAISON ROLE REGARDING CERVICAL CANCER EFFORTS AND THE CENTER IS STARTING TO DISCUSS THE TOPIC OF NEW LEADERSHIP. THAT IS A POSITION AS I HAVE DESCRIBED, WE ARE IN THE PROCESS OF OPENING AND ARE LOOKING FOR THE BEST POSSIBLE CANDIDATES TO RUN THIS VERY IMPORTANT CENTER FOR NCI. BOB CROYLE HAS ABLY STEPPED IN TO HELP LEAD THIS CGH AS CENTER DIRECTOR, WONDER IF BOB WOULD MAKE A FEW REMARKS HOW THINGS ARE GOING. >> THANKS TO THE WORKING GROUP FOR REALLY PLAYER AND ACTIONABLE SET OF RECOMMENDATIONS. SO THE PAST FEW WEEKS THE INITIAL CHARGE IS TO GET A RUNNING HEAD START ON IMPLEMENTATION OF THESE WORKING GROUP RECOMMENDATIONS. A LOT RESONATED. PRIORITIZATION WAS FRONT AND CENTER, THAT WAS MADE CLEAR BY THE GROUP BUT ALSO APPRECIATE PROPOSED LIST OF CRITERIA FOR PRIORITIZING WHICH WOULD -- VERY HELPFUL ALREADY. AS NED SAID, WE HAVE ALSO LAUNCH IN THE PROCESS FOR A SEARCH FOR PERMANENT DIRECTOR. MEANTIME WE HAVE A FEW SHORT TERM ACTION ITEMS FOCUSED ON THE CLOSE-OUT OF FISCAL YEAR 18 ITEMS AND CENTER FOR GLOBAL HEALTH SO CGH HAS CONTRACTS, GRANTS, ENTERAGENCY AGREEMENTS, NUMBER OF PARTNERSHIPS WITH INTERNATIONAL ORGANIZATIONS AND TO THE DEGREE ALL THOSE NEEDS REVIEW A QUICK ASSESSMENT BY ENDS OF CURRENT FISCAL YEAR THAT WAS KEY SOME WE CAN WRAP UP THIS FISCAL YEAR ON BEHALF OF THE INSTITUTE. WE HAVE TAKEN ON RAPIDLY SOME OF THE RECOMMENDATIONS ON COMMUNICATION, IF THOSE OF YOU INTERESTED, I POSTED A BLOG ON THE CTH WEBSITE WHICH SUMMARIZES MOM RESPONSE AND INITIAL APPROACH TO THE WORKING GROUP RECOMMENDATIONS. WE ALSO INCREASED THE TRANSPARENCY OF THE ACTIVITIES IN THE CENTER BOTH FOR THE INTERNAL NCI AND EXTERNAL STAKEHOLDERS. THAT CAME UP IN DISCUSSIONS AS WELL. SHIFTING TOWARDS RESEARCH IS SOMETHING THAT WILL TAKE TIME BECAUSE DEVELOPING AND IDENTIFYING THE APPROPRIATE MECHANISMS, THIS IS SOMETHING THE WORKING GROUP DISCUSSED, AND THERE WAS A FOCUS ONLY RAPIDS SCALE UP AND THEREFORE SUPPLEMENTS ARE RELIED ON FAIRLY HEAVILY BUT U THINK GOING FORWARD, -- I THINK GOING FORWARD THE RECOMMENDATION OF SUSTAINABILITY OF FUNDING IS REALLY USEFUL BECAUSE WE NEED TO IDENTIFY PEER REVIEWED GRANT MECHANISMS TO SUPPORT ACTIVITIES MORE SO THAN ONE SHOT SUPPLEMENTS OR LUMP SUM AGREEMENTS WITH OTHER ORGANIZATIONS. SO TO THE DEGREE WE CAN MIGRATE ACTIVITIES INTO THE REGULAR GRANTS MECHANISMS OF PROCESSES AND WORK WITH THE FOGARTY INTERNATIONAL CENTER, WE ARE DOING THAT, WE ARE DOING ASSESSMENT OF ACTIVITIES WITHIN CANCER CENTERS, THAT'S NEARLY FINISHED. WE HAVE FIVE OR SIX CENTERS REMAINING THAT ARE -- WE WANT TO FOLLOW-UP WITH TO GET RESPONSES TO BUT THAT'S GOING TO BE A KEY PIECE OF THIS MOVING FORWARD. FINALLY GOVERNANCE, ONE THING THAT CAME UP AS WELL, THIS RELATES TO PRIORITY SETTING IS A NEED TO IMPROVE THE GOVERNANCE OF THE CENTERS ACTIVITIES BECAUSE THEY RELATE TO ALL THE NCI INTRAMURALLY AND EXTRAMURALLY SO WE NEED A BETTER INTERCONNECTEDNESS BETWEEN CGH AND ACROSS THE DIVISIONS, IN ADDITION WE WANT TO INCREASE INCREASE BROADER OVER SIGHT AND GOVERNANCE HOW GLOBAL HEALTH PRIORITIES ARE SETS. IN THE CLINICAL TRIALS A FEW YEARS AGO THE INSTITUTE -- C TRUCK THAT JIM DOROSHOW SHARES, IS THAT INTERIM GOVERNANCE WAS CREATEDDED TO ADDRESS SOME ISSUES ABOUT COORDINATION OF CLINICAL TRIALS INTRAMURAL AND EXTRAMURALLY, MAKE SURE EVERYBODY KNOWS WHAT EVERYTHING IS DOING BUT ALSO PROVIDE SOME CLOSE LEVEL VETTING OF CONCEPTS AND INITIATIVES AND PRIORITIES IN THE CLINICAL TRIALS DOMAIN SO WE ENVISION SIMILAR PROCESS PERMITTED IN GLOBAL HEALTH TO ENGAGE CENTERS AND PATIENTS EXTRAMURALLY AND INTERNAL PRIORITY SETTING AND AS WE BRING BACK PROPOSALS TO YOU AND TO THE PSA FOR THE NORMAL PROCESS IS -- SO THAT WE HAVE A BLOODER COMMUNITY ENGAGEMENT IN HOW WE SET PRY YOU -- BROADER COMMUNITY AND HOW WE SET GOALS AND FUN ACTIVITIES. >> DOUG, A FEW WORDS, DOUG HAS BEEN PLAYING IN ADVISORY ROLE AND LEADER OF NCI EFFORTS FOREVER, ALMOST. >> THANKS, NED. BOB HAS REALLY COVERED THE SITUATION. THE BOTTOM LINE IS WE ARE TAKING THE RECOMMENDATIONS WE HAD ALREADY SEEN OF THE GROUP, WE GREATLY APPRECIATE DIDN'T SATEESH AND OTHERS HAVING MADE THIS EVALUATION AND THESE RECOMMENDATIONS AND WE ARE GOING FORWARD TRYING TO MAKE ITN'T ONE HAND INSTITUTE CHANGES WE THINK ARE GOING TO STRENGTHEN CGH WHILE AT THE SAME TIME NOT TIEING THE HANDS OF WHOEVER ENDS UP BEING CHOSEN TO BE THE PERMANENT LEADER. >> GREAT. THANK YOU. ANY OTHER COMMENTS BEFORE WE TAKE A VOTE IN? SO THIS IS THE FINAL REPORT. SO I WOULD LIKE TO TAKE A VOTE TO ACCEPT THE FINAL REPORT. CAN I GET A MOTION TO ACCEPT? SECOND. ALL THOSE IN FAVOR PLEASE RAISE YOUR HAND. ANYONE AGAINST. ANYONE ABSTAINING? THANK YOU, SUE. THE REPORT IS ACCEPTED. >> ONCE AGAIN, THAT'S MARVELOUS FOR DOING THIS. THANK YOU SO MUCH, DEB AND SATEESH FROM THE WORKING GROUP. >> THANK YOU, I DON'T KNOW WHAT TIME IT IS THERE BUT APPRECIATE YOU BEING ONLINE. >> THANK YOU VERY MUCH. THAT WAS WONDERFUL FOR US. SO THIS CONCLUDES THE OPEN SESSION.