>> GOOD MORNING, EVERYONE. WELCOME TO TODAY'S BOARD OF SCIENTIFIC ADVISERS MEETING. I WANT TO WELCOME MEMBERS IN PARTICULAR, THE NEW MEMBERS OF THE BSA, FRANCIS OLISMAN FROM DUKE. WHERE'S FRANCIS? THANK YOU FOR COMING. KAREN IMMONS, FROM THE DANA FARBER INSTITUTE, THANK YOU KAREN. >> STAN FROM CASE, AND LINCOLN STEIN FROM THE ONTARIO INSTITUTE FOR CANCER RESEARCH. THERE ARE SEVERAL OTHER NEW MEMBERS WHO WERE BT ABLE TO GET THIS FIRST MEETING ON THEIR CALENDARS THAT THEY INCLUDE-- >> [INDISCERNIBLE] >> OH--SORRY! TED LAWRENCE FROM MICHIGAN. APOLOGIES. THANK YOU. >> [INDISCERNIBLE] >> EXACTLY. >> WE SEE RIGHT THROUGH THEM. >> THE OTHER NEW MEMBERS, FROM M. I.T., OREGON, UT SOUTHWESTERN AND HARVARD I'M SURE WILL BE HERE AT THE NEXT MEETING. >> OR ELSE! >> OR ELSE! >> AND I ALSO WANT TO WELCOME SPECIAL GUESTS BRIAN AND BOB, WHO HAVE BEEN INVOLVED IN THE caBIG SUBCOMMITTEE AND WE'LL HEAR FROM THAT SUBCOMMITTEE LATER TODAY. I HAVE A FEW THINGS THAT I HAVE TO READ VERBATIM OTHERWISE I'LL BE SCOLDED BY PAULET GRAY. A MEMBER OF THE PUBLIC WHO MAY WISH TO EXPRESS VIEWS REGUARDING ANY ITEMS DISCUSSED DURING THIS MEETING, WE DO SO IN WRITING TO DR. PAULET GRAY, EXECUTIVE SECRETARY OF THE BOARD WITHIN 10 DAYS AFTER THE MEETING, ANY WRITTEN STATEMENTS BY THE PUBLIC WILL RECEIVE CAREFUL CONSIDERATION. AS BOARD MEMBERS YOU MUST ABSENT YOURSELF DURING SPECIFIC DISCUSSIONS WHENEVER YOUR DELIBERATIONS AND DISCUSSIONS ON A PARTICULAR PRODUCT, PROGRAM OR SPECIFIC MATTER WOULD CREATE A CONFLICT OF INTEREST OR THE APPEARANCE OF ONE. IT IS INCUMBENT UPON YOU TO ADVISE THE EXECUTIVE SECRETARY AND ABSTAIN IN ANY DISCUSSION OR ACTION REGUARD TAG MATTER. IN LIGHT OF THE CURRENT POLICIES GOCHING CONFLICT OF INTEREST, BASED ON FINANCIAL HOLDINGS OF SPECIAL GOVERNMENT EMPLOYEES, WHICH CATEGORY INCLUDES ALL MEMBERS OF THIS BOARD, WE MUST DEPEND ON YOU TO VOLUNTARILY ABSENT YOURSELF DURING ANY AND ALL DISCUSSIONS OF MATTERS THAT COULD CONCEIVABLILY IMPACT THE STAT US OF THOSE HOLDINGS. WE TRUST YOUR JUDGMENT IN THESE INSTANCES AND IF YOU HAVE ANY QUESTIONS YOU SHOULD ASK PAULET FOR GUIDANCE. DURING ANY CLOSED SESSION, MATERIALS OR DISCUSSION OF A CONFIDENTIAL NATURE, DELIBERATED ON TODAY ARE PRIVILEGED INFORMATION AND ARE MADE AVAILABLE TO YOU ON A NEED TO KNOW BASIS. SUCH DELIBERATIONS ARE PRIVATE IN THE CONTENTS IT SHOULD NOT BE DIVULGED. I WANT TO REMIND EVERYONE TO TURN YOUR CELL PHONES OFF. USE THE MICROPHONE SO THAT PEOPLE WHO ARE LISTENING FROM FAR AWAY LANDS AND THERE ARE MANY, SUCH INDIVIDUALS CAN HEAR YOU AND SO THE RECORDER, VERBATIM RECORDER CAN GET ALL OF YOUR COMMENTS. THE MEETING BOOK AS FUTURE MEETING DATES WHICH YOU SHOULD HAVE ON YOUR CALENDAR AND THE FIRST ITEM OF BUSINESS IS TO VOTE ON THE APPROVAL OF THE JUNE 2011 MINUTES. I'M SURE YOU ALL REVIEWED THEM. ARE THERE ANY SUGGESTIONS FOR ADDITIONS, MODIFICATION SYMPATHETIC NERVOUS SYSTEM SYSTEM--MODIFICATIONS? >> MOTION TO APPROVE. >> SO MOVED. >> NO FURTHER DISCUSSION, ALL IN FAVOR OF AAPPROVAL? >> ANY OPPOSED? >> THE MEETING ARE APPROVED. OKAY, SO THE FIRST REAL ITEM OF BUSINESS IS TO HEAR FROM DR. VARMUS ON HIS PERSPECTIVE ON WHAT'S GOING ON AT NCI. >> THANK YOU TODD. >> FIRST, WELCOME TO THE NEW MEMBERS AND MANY THANKS TO TODD FAR TAKE THANKSGIVING ON AS A FIRST MEETING AND ALREADY READ HIS DIRECTIONS VERY, VERY, CRISPLY AND WE CONGRATULATE HIM ON SUCCESSFUL FIRST--[INDISCERNIBLE]--GOOD READING FROM THE THAT, THAT WAS GOOD. [LAUGHTER] A COUPLE OF PIECES OF ADVICE--JUST A FEW STATEMENT TOTS NEW MEMBERS. THIS IS INTENDED TO BE A RELATIVELY IPT GREATER FORMAL MEETING EVEN THOUGH IT'S AN OFFICIAL„i MEETING AND OPEN TO THE PUBLIC. YOU DON'T NEED TO WEAR A TIE, I DON'T. CAN YOU INTERRUPT ME AT ANY TIME. I WILL INTERRUPT OTHER PEOPLE AND I HOPE IT WILL BE FREE FLOWUS, WE'VE TRIED TO ESTABLISH SINCE I'VE BEEN HERE ON JULY 12, 2010 AND LOOK FORWARD TO SEEING THE OTHER FOUR MEMBER WHO IS COULDN'T MAKE IT THIS TIME, NEXT TIME. I WILL HAVE A RELATIVELY SHORT REPORT, I HOPE, THAT'S THE PLAN. SO FEEL FREE TO INTERRUPT AND STATE SOME QUESTIONS. YOU'LL BE HEARING FROM MY DISTINGUISHED DEPUTIES TO MY RIGHT, DR. LOWY AND JIM DOROSHOW BRIEFLY AND ALSO IN RESPONSE TO QUESTIONS. SO FIRST ITEM IS THE THING YOU COME HERE TO GET SOME DEEP SECRETS ABOUT. I DON'T HAVE ANY DEEP SECRETS ON BUDGETS AND FUNDING OR BUDGETS AND COPING, I'M NOT SURE WHAT THE RIGHT GERUND IS. LET ME GIVE YOU A BRIEF REMINDER AND UPDATE O WHERE WE ARE. JUST A WORD ABOUT THE FISCAL YEAR THAT CONCLUDED A COUPLE OF MONTHS AGO. FISCAL YEAR 11 AND YOU WILL REMEMBER THAT THAT WAS A SHOCKING YEAR. WE HAD A--BUDGET WAS 1 PERCENT BELOW THE PREVIOUS YEAR, SOMETHING I HAD NEVER EXPERIENCED BEFORE WHILE WORKING HERE THAT IS 1 PERCENT BELOW THE 2010 LEVEL. THE NCI, AS I'M SURE YOU ALL REMEMBER HAD SPECIAL PROBLEMS BECAUSE OF OUR UNEXPECTEDLY LARGE COMMITMENT BASE AND SOME COMMITMENTS TO CONSTRUCTION PROJECTS AND SOME--WELL, I CAN EXPLAIN THE COMMITMENT BASE PROBLEM BUT YOU READ THE LEDDERS IN THE PAST AND POTENTIALLY IRRELEVANT NOW AND TRY TO KEEP THE GRANT NUMBERS UP, KEEP OUR MOMENTUM IN REVISING THE CLINICAL TRIAL SYSTEM AND KEEPING THE MACHINES AND GENOMICS GOING. WE BASICALLY APPLIED HAIR CUTS TO EVERYTHING. ANYTHING FROM A ONE-5 PERCENT REDUCTION OF ALL PROGRAMS TO TRY TO KEEP THE GRANT NUMBERS IN A REASONABLE RANGE AND KEEP THESE PROGRAMS GOING AT FULL BLAST. WE KNOW NOW THAT WE'LL FUND ROUGHLY 11 HELPED NEW GRANTS, RPGs IN THIS--WE DID FUND IN 2011 ROUGHLY 1100 GRANTS WHICH IS DOWN FROM THE PREVIOUS YEAR BUT IT WAS ROUGHLY THE TARGET WE WERE AIMING FOR, THE AVERAGE SIZE OF GRANTS WAS DECLINED A LITTLE BIT. OUR SUCCESS RATE WAS ABOUT 14%, VERY SIMILAR TO THE OVERALL SUCCESS RATE, ACROSS THE NIH, DIFFERING BY LESS THAN A PERCENTAGE POINT. AND WE FEEL WE HAD GIVEN THE TOUGH TIMES WERE RELATIVELY SUCCESSFUL. YOU REMEMBERLET LEVERS WE PULL OFFICE OF DIVERSITY TYPE FIVES BUT THAT IS IN A SENSE A STATEMENT ABOUT THE PAST. 2012 IS A YEAR STILL IN FLUX. THE--AS YOU'LL HEAR IN A MOMENT, THE PROPOSALS FOR THE NIH--FOR THE NIH AND FOR NCI BECAUSE RIGHT NOW WE'RE NOT DISCRIMINATING AMONG INSTITUTES COULD BEING ANYWHERE FROM A MINUS ONE RELATIVE TO 2011, TWO PLUS THREE WHICH WOULD BE ESSENTIALLY VERY, VERY, SIMILAR TO THE PRESIDENT'S PROPOSAL. WE ARE NOW ON A CONTINUING RESOLUTION THAT LASTS UNTIL THE 18th OF NOVEMBER, THAT CONTINUING RESOLUTION IS ROUGHLY 1.5% BELOW LAST YEAR'S LEVEL. IN THIS CONTEXT WE'RE TAKING A–r RELATIVE POSITION WITH RESPECT TO MAKING AWARDS. THIS IS NOT DIFFERENT FROM PREVIOUS YEARS. WE'RE PAYING THE TYPE FIVE AWARDS, RENEWALS AT 90% WHICH IS TRADITIONAL UNDER THESE CIRCUMSTANCES FOR THE CR, AND WE WILL PAY ABOUT 80% OF THE COSTS OF APPROVED DIP ONES AND TWOS. THAT IS NEW AND COMPETING AWARDS UNTIL WE GET A FULL BUDGET. THIS NUMBER WILL GO UP BUT WE'RE TRYING TO GET SOME MONEY OUT THE DOOR SO PEOPLE CAN GET TO WORK. WE'LL FUND FROM THE SEVENTH PERCENTILE ON DOWN AND THEN WE'LL LOOK AT GRANTS BELOW THAT AND PLAYING CAUTIOUSLY BECAUSE WE DON'T KNOW WHERE WE WILL END UP HERE, THERE ARE NOT A LOT THINGS IN MOTION AS I'LL MENTION IN A MOMENT BECAUSE THE FINAL FUNDING DECISIONS WILL HAVE TO DEPEND ON A GETTING A FINAL BUDGET AND WE WON'T HAVE A FINAL BUDGET PROBABLILY UNTIL SOMETIME NEXT CALENDAR YEAR, WE ARE LIKELY TO HAVE ANOTHER CONTINUING RESOLUTION AS OF NOVEMBER 18th, POSSIBLY TAGGED ON TO ONE OF THE SO CALLED MANY BUS PROPOSALS LOOPING THEIR 13 APPROPRIATION BILLS, SOME YEARS WE HAVE AN OMNIBUS, THIS YEAR WE MAY HAVE A SERIES OF MINIBUSES IN WHICH, THREE OR FOUR APPROPRIATION BILLS ARE BUNDLED. WE WILL DEFINITELY NOT BE THE FIRST, WE'RE LIKELY TO BE THE LAST, THE LARGEST APPROPRIATION BILL, WE'RE THROWN TOGETHER, HHS, LABOR AND EDUCATION, IT WAS A DIFFICULT BILL. AND WOULDN'T SURPRISE ME IF WE DIDN'T HAVE A FINAL BILL UNTIL SOMETIME IN THE WINTER OR EVEN EARLY SPRING. THAT WAS THE CASE LAST YEAR. WE HAVE BEEN DISCUSSING HOW TO DEAL WITH THE BUDGETS THAT WE MIGHT HAVE THIS YEAR AND WE HAD A RETREAT IN JULY WHICH CHI DANG WAS THE BSA, THE RETREAT CONSISTED OF FOLKS FROM THE SENIOR LEFT-SIDERSHIP AT THE NCI, BUT WE TALKED FROM GREAT DETAIL ABOUT HOW WE'RE GOING TO ADAPT TO A NEGAATIVE BUDGET IF WE HAVE ONE. I THINK THE GENERAL CONSENSUS, WITHIN THAT I CERTAINLY--A POINT OF VIEW I AGREE WITH IS THAT WE ARE NOT JUST GOING TO SHRINK THINGS FOREVER BY TAKING HAIR CUTS ALL AROUND. WE NEED TO MAKE PROGRAMMATIC DECISIONHOW WE DEAL WITH BUDGET REDUCTIONS AND MY OWN VIEW IS WHEN WE HAVE PROGRAMS THAT WE THINK HAVE NOT BEEN THAT PRODUCTIVE THAT WE SHOULD DECREASE THEM IF NOT STOP THEM. AND I'LL BE SEEKING YOUR HELP IN THOSE AREAS AND I HAVE BEEN DOING ALL ALONG AND THAT MAY TAKE A FORM THAT'S MORE FORMAL THAN JUST DISCUSSION HERE. AND AS YOU KNOW,--AND WE'LL HEAR ABOUT IN FURTHER DETAIL--WE HAVE BEEN LOOKING AT INITIATIVES LIKE caBIG AND OTHERS THROUGH THE ENGINE OF THE BSA, I SHOULD SAY A LITTLE BIT ABOUT THE THE CURRENT PROPOSALS FOR--THAT ARE ON THE TABLE FOR 2012. THE SENATE HAS PROPOSED A VERY MODEST DECREASE, ROUGHLY .6% DECREASE AND WHEN YOU ADD IN A FEW TAPS FOR DEPARTMENTMENTAL ACTIVITIES THAT WILL APPROXIMATE THEM A MINUS ONE% DECREASE. BUT THE BILL IS ONE THAT'S BEEN PROPOSED BY THE SENATE APPROPRIATIONS SUBCOMMITTEE THAT AFFECTS US IS FREE--IT'S A CLEAN BILL. FREE OF STIPULATIONS THAT WOULD HARM US IN WAYS THAT I'LL DESCRIBE HAD IN JUST A MOMENT WHEN I TALK ABOUT THE HOUSE SIDE. AN EFFORT WAS MADE TO TRY TO PUT A LITTLE MORE MUNY BACK IN. THAT EFFORT CAME FROM THE REPUBLICAN SIDE, FROM MR. MORAN FROM KANSAS, THAT WAS REBUFFED BY THE DEMOCRATIC LEADERSHIP ON THE GROUNDS THAT THERE WERE OTHER VERY IMPORTANT PROGRAMS THAT WEREN'T GETTING FUNDED BECAUSE THE ALLOCATION TO THAT SUBCOMMITTEE WAS VERY, VERY, LIMITED. NEVERTHELESS, UNDER THE CIRCUMSTANCES IN WHICH MANY AGENCIES ARE BEING HIT MUCH MORE HEAVILY THAN THAT, NOT TERRIBLE, NOT GOOD, BUT NOT TERRIBLE. ON ON THE HOUSE SIDE, THE BUDGET NUMBER LOOKS GOOD, CROSS 3 PERCENT, IT'S SIMILAR TO THE PRESIDENT'S PROPOSAL WHICH HAD BEEN 2 PERCENT ABOVE 2010. THAT IS NOT A CONSENSUS DOCUMENT FROM THE HOUSE SIDE BECAUSE THIS WAS ONLY THE PROPOSAL BY HERBS NEIGHBOR, AND DENNY RAYBERG, OF THE COMMITTEE AND NOT VETTED BY THE REST OF THE COMMITTEE IS THAT PROPOSAL IS SADDLED WITH A NUMBER OF OTHER STIPULATIONS ABOUT THE ACTUAL NUMBER OF NEW AND COMPETING GRANTS THAT THE NIH SHOULD BE SUSTAINING AND SUPPORTING IN 2012, A FORMULA FOR INTRUSION OF MONEY BETWEEN INTRAMURAL AND EXTRAMURAL PROGRAMS AND SOME OTHER STATEMENTS THAT ARE AN AS MA TO US. WE DON'T UPON TO BE INAPPROPRIATELY GOVERNED BY THE CONGRESS, NOT HAVING THEM MAKE CLAIMS OR ADDITIONS FOR OUR--CONDITIONS FOR OUR AWARD THAT ARE REALLY NOT IN THEIR PERVIEW. IT IS OF COURSE, THAT WAS QUITE STRIKING THAT THE HOUSE PROPOSAL FROM MR. RAYBURN DOES NOT MENTION THE NEW TRANSLITIONAL SCIENCES INSTITUTE, LOTS OF MONEY TO THE NATIONAL CENTER FOR RESEARCH RESOURCES WHICH IS GOING TO BE CLOSED. AND THEN N A SENSE, THERE WAS A POLITICAL STATEMENT THERE ABOUT WHAT--ABOUT THEIR VIEWS ON THE TRANSLATIONAL SCIENCES INITIATIVES THAT WE DISCUSSED HERE LAST TIME. WHAT'S GOING TO HAPPEN IN 2013. WELL, OF COURSE, RIGHT NOW, NCI AND THE NIH GENERALLY ARE IN THE PROCESS OF TRYING TO DEVELOP A BUDGET PROPOSAL THAT WILL BE CONSIDERED BY OMB AND MADE PART OF THE PRESIDENT'S BUDGET PROPOSAL WHICH WOULD BE RELEASE INDEED JANUARY. RIGHT NOW, THE INSTITUTES HAVE EACH BEEN ASKED TO SUBMIT THREE NEW INITIATIVES AND A SUBGROUP OF INSTITUTE DIRECTORS ARE JUDGING THOSE AND WHEN FRANCIS SENDS--FRANCIS COLLINS SENDS HIS PROPOSAL TO THE DEPARTMENT, ALL INSTITUTES WILL NOT BE EQUAL, SOME WILL HAVE BETTER PROSPECTS THAN OTHERS BASED ON THESE INITIATIVES. NCI OF COURSE IS SUBMITTED ITS OWN AND WE CAN TALK ABOUT THAT IF YOU WANT, BUT THEY ARE IN AREAS THAT INCLUDE DRUG DEVELOPMENT GENOMICS, PREVENTION AND SOME OTHERS. OF COURSE IT'S VERY DIFFICULT TO PREDICT WHERE NIH, OR THE DEPARTMENT IN GENERAL OR NCI FOR THAT MATTER WILL END UP IN THIS PROJECT PROCESS BECAUSE THERE ARE AN AWFUL LOT OF FACTORS THAT ARE PLAY INTOG THESE DECISIONS. INCLUDING HOW THE OMB VALUES THE NIH. HOW THE WHITE HOUSE, THE WHITE HOUSE SAYS ABOUT THE HABIT AND THE SUPER COMMITTEE AND DELIBERATIONS AND THE CONGRESSIONAL RESPONSE TO THE SUPER COMMITTEE DELIBERATIONS AND THE LIKE. THIS IS ALL INFLUENCED BY THE FACT THAT IT'S A PRESIDENTIAL ELECTION YEAR WHICH MAKES THE BUDGET PROCESS MORE COMPLICATED. WE HELD AN NIH RESTREET INSTITUTE AND DIRECTORS AND OTHERS IN AUGUST TO DISCUSS HOW WE WERE DEALING WITH LONG-TERM INDUCTIONS IN OUR BUDGET AND WE LISTENED TO A CHIEF ADMINISTRATOR FROM A LEADING UNIVERSITY TO HEAR HOW THEY DEALT WITH BUDGET REDUCTIONS AND I THINK THE GENERAL CONSENSUS WAS THAT WHILE WE DO HAVE VARIOUS LEAVERS TO PULL AND YOU KNOW WHAT THEY ARE, REDUCING THE NUMBER OF GRANTS PER PERSON, REDUCING THE NUMBER OF DOLLAR PER GRANT, LOWERING THE AVERAGE COST OF GRANTS, PLAYING WITH A CERTAIN ASPECTS OF OUR FUNDING PLAN, CAN YIELD MORE GRANTS BUT THE EMPHASIS MOST OF US TRIED TO PLACE ON THIS DISCUSSION IS THAT WE SHOULD BE LOOKING CLOSELY AT OUR ESSENTIAL MISSION AND OUR VALUES AND BE DOING THE THINGS THAT ARE GOING TO PRODUCE SCIENCE THAT WILL IMPROVE THE NATION'S HEALTH AND WE SHOULD EVALUATE OUR PROGRAMS AND NOT WORRY SO MUCH ABOUT THE PRECISE NUMBERS AND I CERTAINLY AGREE WITH THAT AND WE CAN TALK ABOUT THAT A LITTLE FURTHER IF APPROXIMATE YOU LIKE. ONE OTHER ASSPECT OF THE 2013 EXERCISE OF COURSE IS AT THE NCI IS ALWAYS THE WRITING OF OUR BYPASS BUDGET PROPOSAL. THE NUMBERS NOT NEARLY AS IMPORTANT AS THE TEXT. THIS YEAR WE'RE HEAD OF THE GAME AND ON TIME. AND AS WE DID LAST YEAR, FOR THOSE OF YOU WHO REMEMBER THE BYPASS BUDGET REPORT, WE WILL FEATURE SIX NEW--SIX CANCERS THAT WERE NOT FEATURED FROM LAST YEAR AND SOME YOU WILL HEAR ABOUT TODAY SUCH AS THE GLOBAL HEALTH INITIATIVES. LET ME GIVE YOU FAMILIAR UPS ON THINGS--THERE ARE ANY QUESTIONS ABOUT BUDGET STUFF? FEW FOLLOW UPS. YOU HEARD LAST TIME ABOUT THE PROVOCATIVE QUESTIONS INITIATIVE THAT HAS BEEN ORGANIZED MAINLY BY ME AND DOUG LOWY AND ED HARLOW AND YOU APPROVED AN RFA TO SET ASIDE 15 MILLION DOLLARSS TO SUPPORT R21S AND RO-1S WITH EVOCATIVE QUESTIONS FROM A SERIES OF WORKSHOPS IN AN OPEN EXCHANGE ON A WEB SITE AND EVALUATION BY OUR SENIOR STAFF. WE--IN MAKING THE ANNOUNCEMENT WE POSTED 24 PROVOCATIVE QUESTIONS, WE ALL--WE IN THE COMMUNITY THOUGHT WERE PARTICULARLY USEFUL AND JUDGING FROM THE RESPONSE SO FAR, INDEED, THESE LOOK PRETTY ATTRACTIVE TO PEOPLE. WE'VE HAD WELL OVER 800 INQUIRIES AND WE'VE RECEIVED NEARLY 700 LETTERS OF INTENT TO APPLY, IF YOU LOOK ACROSS THE RANGE OF QUESTIONS, ALL QUESTIONS HAVE INTERESTED SOMEBODY, SOME CASES TWO O THREE PEOPLE AND SOME CASES AS MANY AS 80. SO, THIS WILL CREATE SOME INTERESTING CHALLENGES IN TERMS OF REVIEW GROUPS. TELL BE CARRIED OUT BY THE NCI, IT IS UNDISCUSHION BY THOSE WHO HAVE TO TAKE RESPONSIBILITY FOR IT. THERE HAVE BEEN A LOT OF VISITS TO OUR WEB SITE, I DON'T REMEMBER THE EXACT NUMBER OF 50,000 A MONTH, SOMETHING LIKE THAT. SO THERE HAVE BEEN A LOT OF INTEREST AND A LOT OF OF COMMENTS ON THE SITE AND A LOT OF QUESTIONS POSTED THERE. IF YOU HAVEN'T LOOKED I URGE YOU TO DO SO, ED HARLOW ARE WRITING AN ESSAY ABOUT HOW THE EXERCISE WAS DONE AND WHY THIS IS A PARTICULARLY ATTRACTIVE WAY IN MY VIEW TO APPROACH THE QUESTION OF HOW TO SET SCIENTIFIC PRIORITIES WHEN MONEY IS TIGHT, THAT IS RATHER THAN MAKE ARBITRARY SOPHISTICATED BEIT STYLES FROM--SO BE IT STYLES FROM ABOVE, LET'S CONSERVE EVERY DOLLAR FOR IDEAS THAT COME FROM THE HEAD OF SINGLE INVESTIGATORS, LET'S GET THE COMMUNITY TOGETHER AND CONSENSUS ABOUT THE GREAT THINGS WE HAVEN'T DONE THAT WE OUGHT TO DO AND IT'S TURNING OUT TO BE A PRETTY GOOD PROCESS. A FEW OTHER THINGS IN RESPONSE TO THINGS YOU HEARD ABOUT LAST TIME. WE HAD A DISCUSHION HERE LEDS BY JIM DOROSHOW LAST TIME ABOUT THE DRUG SHORTAGE ISSUE THAT NOW EVERYBODY KNOWS ABOUT BECAUSE THE PRESIDENT AND THE NEW YORK TIMES AND THE SCIENCE AND NEW ENGLAND JOURNAL AND OTHER PLACE VS BROUGHT ITS PUBLIC ATTENTION. WE CONTINUE TO BE INVOLVE INDEED DISCUSSIONS WITH OUR COLLEAGUES AND HHS, AND THE WHITE HOUSE AND OF COURSE, THE PRESIDENT HIMSELF HAS PAID ATTENTION TO THIS ISSUE AND ISSUED LAST WEEK AN EXECUTIVE ORDER ON MONDAY TO DO AT LEAST THREE THINGS. ONE IS TO STRENGTHEN THE NOTIFICATION REQUIREMENTS OF THE FDA BY REQUIRING THAT NOTICES AND POTENTIAL SHORTAGES BE ISSUED TO THE FDA EVEN WHEN THERE ARE MULTIPLE SUPPLIERS OF A DRUG. IT IS ENCOURAGED TO EXPEDITE REVIEW OF THE PRODUCTION FACILITY WHEN IS THEY ARE INVOLVE INDEED MAKING GENERICS OF LIKELY SHORT SUPPLY AND AFTER THE DEPARTMENT OF JUSTICE TO LOOK INTO CERTAIN ASPECTS OF THE MARKET FOR GENERICS, ESPECIALLY THE SO-CALLED GRAY MARKET WHICH PROSPERS VITALLY WHEN THERE ARE SHORTAGES BY OVERCHARGING OR CHARGING FAR IN EXCESS OF WHAT'S NORMALLY CHARGED FOR GENERIC PRODUCTS. I DON'T THINK ANYBODY BELIEVES, INCLUDES THE PRESIDENT THAT THIS WILL SOLVE THE PROBLEM. THERE IS LEGISLATION PENDING, MAINLY, A BILL WRITTEN BY AMY CLEANUPITTURE, A SENATOR FROM MINNESOTA, THAT WAS PLACED IN LAW. SOME OF THESE RECOMMENDATIONS FOR HOW THE FDA SURVEYS THE PROBLEM AND KEEPS UP WITH SHORTAGES AND AS SHE NOTICES, THERE COULD BE ROOM FOR STRONGER ISSUES. THERE IS--THERE HAVE BEEN TWO RESILIENCE SPORTS ISSUED--REPORTS ISSUED. ONE FROM THE FDA IN HOW THEY PROGRESS THE PROGRAM OF DRUG SHORTAGES AND THE OTHER FROM PROGRAM AND EVALUATION THAT ANALYZES THE MARKET FORCES. THAT REPORT, I PARTICULARLY RECOMMEND TO YOU, IT'S VERY, VERY, INSIGHTFULLY WRITTEN BY SHERRY GLEBE AND HER COLLEAGUES AND WE'RE CONTINUING DISCUSSIONS WITH PEOPLE IN THE OFFICE OF THE SECRETARY FOR HEALTH AND PLANNING AND EVALUATION. HOPING TO PLAY IT AND CONTINUING TO PLAY A SIGNIFICANT ROLE IN OW WE MIGHT FURTHER STRENGTHEN THE DEPARTMENTS INVOLVEMENT IN TRYING TO KEEP FROM INTERNING SHORTAGES, ESPECIALLY OF ONCOLOGICAL DRUGS. THERE IS REASON TO BELIEVE THAT ONE MIGHT BE A USEFUL ONE TO PURSUE IS A QUESTION OF HOW LARGE PURCHASERS OF DRUGS THAT ARE GENERIC, AND THESE WOULD BE LIKE GENERIC INJECTABLES WRITE THEIR CONTRACTS AND COULD THESE BE STRENGTHENED IN A WAY THAT MIGHT LEAD TO MODEST INCREASE IN PRICES BUT WOULD LEAD TO A GREATER PENALTIES FOR COMPANIES THAT FAILED--FAILED TO PROVIDE TO THE PURCHASERS WHAT THEY NEED. SO THAT KIND OF THING WHICH IS RESPONSIVE TO MARKET FORCES IS EESPECIALLY PROMISING AS A WAY TO TRY TO DEAL WITH THIS RECURRENT PROBLEM. WE ALSO H. I.T A BRIEF DISCUSSION LAST TIME LED BY DINA I THINK SINGER ABOUT R21S, WE ARE MINDFUL OF THE CAUTIONS THAT WE GOT FROM BSA, BUT WE ARE PREPARING AN OMNIBUS ANNOUNCEMENT WITH R21S. WE ARE VERY CLEAR ABOUT NOT USING THIS AS A SUBSTITUTE FOR RO-1S FOR EARLY STAGE INVESTIGATORS BUT NEVERTHELESS, WE EXPECT TO DO A WAY WITH THE MULTIPLE R21 ANNOUNCEMENTS WE HAVE AND BRING THEM TOGETHER UNDER AN OMNIBUS PROPOSAL. A COUPLE OF THINGS ABOUT ADVISORY COMMITTEES, YOU WILL HEAR FROM DAN MAZEUS AND HIS COLLEAGUES IN A FEW MOMENTS ABOUT THE CONTINUED OVERSIGHT OF THE caBIG PROGRAM. I'M GRATEFUL TO OTHERS WHO'VE COME FOR THOSE ON BSA OR OTHERS I MENTIONED WHO ARE HERE TODAY TO HELP US EVALUATE HOW THAT OVERSIGHT PROCESS IS GOING. THERE ARE A FEW OTHER DOMAINS IN WHICH WE MIGHT WANT TO CONSIDER HAVING A BSA SUBCOMMITTEE OR AT LEAST SOME EXTENSIVE DISCUSSIONS, I'LL COME TO THOSE IN A MOMENT. ANOTHER NEW ACCORD FATING COMMITTEE WHICH IS NOT A BSA SUBSIDIARY, BUT NEVERTHELESS VERY IMPORTANT IS A NEW--ADVISORY COMMITTEE TO NIH FREDERICK. IN ITS REPORT ON THE STATE OF THE NCI THAT RECEIVED FROM THE NATIONAL CANCER ADVISORY BOARD LAST FALL, WAS A SET OF CONCERNS ABOUT WHAT IS BEING DONE AT NIH FREDERICK. AND I THINK ALL OF US ACKNOWLEDGE THAT FREDERICK IS A COMPLEX ORGANIZATION. WHAT WE HAVE THERE IS IN THE FORM OF A CONTRACT PROGRAM THAT'S PARTICULARLY USEFUL, IT SUPPLIES US THE FLEXIBILITYS THAT NOBODY ELSE IN THE DEPARTMENT OF HHS HAS. BLUE THE--BUT THE NATURE OF THE ORGANIZATION MAY BE SEEN AS LESS THAN A FULLY TRANSPARENT OPERATION NEEDS TO BE BROUGHT OUT WITH A LIGHT AND WE'VE ASSEMBLED A REALLY OUTSTANDING COMMITTEE OF TO OVERSEE THE FREDERICK OPERATIONS CHAIRED BY ZACH HALL WHO USED TO BE THE HEAD OF THE NEUROLOGY INSTITUTE OF THE NIH. AND THEY HAVE MET ONCE, KIND OF AN ORIENTATION MEETING, HEARD FROM MANY PEOPLE AT FREDERICK, BOTH SCIENTIST SYSTEM ADMINISTRATORS AND THE NEW HEAD OF THE MAJOR CONTRACTOR THERE, SAIC, DAVE HYMERRIC. DAVE HYMERRIC, I'M SORRY. AND I'M--EXTERNAL INVESTIGATORS AT FREDERICK AND WE'RE DOING THAT. THEY'VE ASKED US TO--MORE SUCCINCTLY STATE NCIs OBJECTIVES AT FREDERICK AND WE'RE WORKING ON THAT. THERE'S BEEN SOME DISCUSSION OF THE RIGHT NAME FOR FREDERICK. PERHAPS GIVE IT A BIT MORE CLOUD, NAME IT ALONG THE LINES„i THAT ARE USED–r AT THE CENTER--CONTRACT OPERATIONS OVERSEEN BY THE DEPARTMENT OF ENERGY FOR EXAMPLE, AND THEY'VE SUPPORTED THE IDEA OF DEVELOPING A KREDDA POLICY FOR CONTRACTING ORGANIZATION AND THAT SEEMS TO BE MOVING THROUGH QUITE SWIFTLY. LET ME SAY A FEW THINGS ABOUT SOME ACTIVITIES THAT I'VE BEEN INVOLVED IN ABROAD BECAUSE THEY BEAR ON SOME OF THE THINGS THAT WILL BE DISCUSSING HERE. WHEN I CAME TO THIS JOB, I WAS REMINDED OF A--AN ORGANIZATION THAT I HELPED TO DEVELOP IN THE MID90 WHEN IS I WAS NIH DIRECTOR THAT BROUGHT THE LEADERS OF RESEARCH ORGANIZATION TOGETHER TO DISCUSS COMMON PROBLEMS AND THIS GROUP WHICH IS NOW KNOWN AS THE HERO GROUP, HIRO, HEADS THE NATIONAL RESEARCH ORGANIZATION CONTINUES TO BE FAIRLY USEFUL, BUT I WANTED TO DO SOMETHING THAT REFLECTED THE CONCERNS COMMONNALLITYS OF PURPOSE WHO RUN CANC E-PRESCRIBING RESEARCH, ORGANIZATION, IS CANCER RESEARCH FUNDING ORGANIZATIONS AND SO IN COLLABORATION WITH HARP OLDER PEOPLE KUMAR, WHO IS THE CEO OF CANCER RESEARCH UK, WE ORGANIZED A MEET NOTHING LOND AN AT THE MEETING IN SEPTEMBER THAT INCLUDED REPRESENTATION FROM ABOUT 15 OR 18 COUNTRIES, MAINLY PEOPLE WHO HAD FUNDING ORGANIZATIONINGS BUT SOME WHO--ORGANIZATIONS BUT SOME WHO ARE LEADERS IN CANCER RESEARCH ORGANIZATIONS IN A WIDE VARIETY OF COUNTRIES. MOST IN EUROPE, BUT A FEW FROM SEBTERAL AND SOUTH AMERICA AND A FEW FROM ASIA AS WELL. DURING THE COURSE OF THE ONE AND HALF DAY MEETING WE DISCUSSED A NUMBER OF THINGS YOU WILL RECOGNIZE AS THINGS THAT ARE ON OUR MINDS ALL THE TIME. HOW DO WE TAKE GENOMICS INTO THE CLINIC, HOW DO WE DO MORE TO IMPROVE THE CARE OF PATIENTS IN FOUR COUNTRIES. WE ALL KNOW--I'M SURE YOU ALL PAID ATTENTION TO THE DISCUSSIONS THAT TED TRIMBLE WILL NO DOUBT ALLUDE TO LATER AT THE U. N. ON THE ATTENTION THAT'S GOING TO BE PAID TO CHRONIC DISEASE AND LOW AND MIDDLE INCOME COUNTRIES, HOW DO WE DO THAT, HOW DO WE ESTABLISH RESEARCH BASE IN THOSE PLACES AND THERE WAS ALSO DISCUSSION ABOUT PREVENTION POLICIES IN DIFFERENT COUNTRIES AND THE ISSUES ABOUT TRAINING AND I THINK IT WAS REALLY QUITE USEFUL TO SHARE POINTS OF VIEW. FOR EXAMPLE, WE HAVE BEEN TALKING ABOUT GENOMICS, IT WAS APPARENT THAT IN SOME COUNTRIES FIJI AND FRANCE, PATIENTS WITH LUNG CANCER VIRTUALLY EVERY PATIENT HAS A PHENOTYPE IN LUNG CANCER, IN SOME COUNTRIES NOTHING WAS DONE AND IN OTHER COUNTRIES THERE WAS A TARGETED RESPONSE AND SEEING WHAT COULD BE DONE. THERE WAS AN AGREEMENT THAT COULD DO BETTER BY WORKING TOGETHER AS LEADERS OF THE GOVERNING INSTITUTIONS THERE WAS AN EXTENSIVE DISCUSSION OF TOBACCO CONTROL IN DIFFERENT COUNTRIES AND I THINK VERY USEFUL .ARE ON HERE TEMPTING THEM , FROM COUNTRIES ABOUT WHAT THE MOST EFFECTIVE MEANS OF PACKAGES TOBACCO PRODUCTS IS ON THE UTILIZATION AND THERE ARE PLACES WHERE CANC E-PRESCRIBING RESEARCH ORGANIZATIONS NIEGZINIZATIONS CAN SPEAK WITH A BIG VOICE IF THEY SPEAK TOGETHER. SO, HARP O AND I HAVE SENT QUESTIONNAIRE OUT TO THE PARTICIPANTS OF THE MEETING. WE ARE TRYING TO MAKE A DECISION ABOUT WHETHER TO PLAN SUBSEQUENT MEETS AND WE'RE IN THE PROCESS OF TRYING TO WRITE UP A REPORT OF WHAT THESE FOLKS HAD TO SAY TO EACH OTHER. FOLLOWING THAT MEETING, I TOOK A--VERY INTERESTING TRIP TO EAST AFRICA TO RWANDA AND UGANDA AND JUST MAKE A FEW REMARKS ABOUT THIS VISIT, THESE VISITS BECAUSE THEY ARE--THEY HAVE A BEARING ON MY OWN VIEW OF WHAT CAN BE DONE INTERNATIONALALLY TO PURSUE RESEARCH ON CANCER AND TRY TO APPROVE CANCER CARE AND PREVENTION IN COUNTRIES. OF LOW ENEMY. THE PRIME---OF LOW INCOME, THE PRIMARY INTEREST WAS TO PARTICIPATE IN THE GROUND BREAKING OF A NEW CANCER RESEARCH HOSPITAL IN UGANDA. SOME OF YOU MAY KNOW THAT NCI HAS BEEN INVOLVED IN CAMPALLA FOR A LONG LONG TIME AFTER DENNIS DORKET DISCOVERED BURKEET'S LYMPHOMA IN THE 50S HE BROUGHT MANY OF HIS PATIENTS TO A CLINIC IN CAMPALLA WHICH IS A UNIVERSITY AND IN 1967 A FORMAL ARRANGEMENT WAS SET UP BETWEEN THE NCI AND ALCAR BONE AND ZIG LEER BECAME THE HEADS OF THIS ORGANIZATION AND LASTED UNTIL THE REIGN WHEN HIS OPPRESSIVE POLICIES ILLUSTRATE ONE OF THE DIFFICULTIES OF TRYING TO WORK IN SOME DEVELOPING COUNTRIES. THE FINANCIAL AND POLITICAL CONSIDERATIONS PLAY A VERY, VERY, LARGE ROLE IN THE KINDS OF PLANS WE CAN ALL MAKE. BUT, THE UGABBEDDA CANCER CENTER HAS SURVIVED WITH THE HELP OF A NUMBER OF IMPORTANT AMERICAN INSTITUTIONS, UCSF, JOHNS HOPKINS, CASE WEST EXPERN QUITE A FEW OTHER VS PARTICIPATED AND NOW FRED HUTCHISON HAS A VERY, VERY, DEEP RELATIONSHIP WITH THIS ORGANIZATION THAT ILLUSTRATES IMPORTANT PRINCIPLES FOR EXAMPLE ABOUT TRAINING. SO THEY HAVE BEEN BRINGING THOSE--THE MOST OUTSTANDING UGANDAN ONCOLOGISTS TO THE HUTCHISON CANCER CENTER FOR ADDITIONAL 15 MONTHS OF TRAINING BOTH IN RESEARCH AND IN CANCER CARE. I THINK THAT'S IMPROVED THE WAY IN WHICH CARE IS BEING ADMINISTERED HERE. I'M NOT GOING TO PRETTIFY THIS. THESE ARE CROWDED WAR--WARDS. THESE ARE PARENTS THAT WOULD NOT DO AS WELL AS THEY WOULD IF THEY WERE ISOLATED AND IF THERE WAS BETTER FOLLOW UP AND BETTER ACCESS TO DRUGS BUT IT IS BEYOND WHAT'S DONE IN THOSE PLACES AND BURKEET'S LYMPHOMA OF COURSE IS AN INTERESTING DISEASE FROM MANY PERSPECTIVES. THE EB V IS THE CAUSE OF DEVELOPMENT, THE RELATIONSHIP WITH MALARIA, THE RESPONSE TO A SINGLE GENERICALLY AVAILABLE CHEMO THERAPY AND THE OPPORTUNITY TO UNDERSTAND THE DISEASE BETTER WITH NEW GENOMICS TECHNOLOGIES SO WE HAVE A--AN ACTIVE ENGAGEMENT NOW WITH THE UCI TRYING TO UNDERSTAND BURKEETS BETTER AS SOME OF YOU KNOW WE'VE BEEN GIVING SOME THOUGHT TO INCORPORATING THE DEVELOPMENT OF VACCINES AGAINST EBV AS PART OF A NEW MULTINIH INSTITUTE EFFORT AND I THINK IT WOULD BE BENEFICIAL MUCH MORE BROADLY THAN JUST IN UGANDA. THE RWANDA EXPERIENCE I MENTIONED BRIEFLY, WAS ONLY THERE FOR A FEW DAYS BUT ANYONE WHO KNOWS THE HISTORY OF RWANDA WOULD BE DONE WHEN YOU GO THERE AT THE COMMITMENT TO IMPROVING HEALTH. UNIVERSAL VACCINATION OF CHILDREN IS THE ORDER OF THE DAY. THEY HAVE WELL OVER 90% THE COMPLIANCE WITH THE VACCINE POLICIES AND EARLY VACCINATION INCLUDES HBV IMPORTANT TO US, MORE OVER THEY HAVE AN HPV ACSEEN INITIATIVE, THAT'S BEEN STRONGLY ASSISTED BY PROVISION OF LOW COST VACCINE BY MERCK WITH HELP FROM GABY, THE GLOBAL ALLIANCE FOR VACCINE I>SK AND THE--THE UTILIZATION RATE OF HUMAN PAPILLOMA VIRUS IN RWANDA IS OVER50%, WAY ABOVE USE IN THE U.S. THAT'S FOR GIRLS IN THE NINE-11 RANGE. SO THAT MAKES YOU SEE WHAT CAN BE DONE. THEY ARE MAKING SOME EFFORTS IN ONCOLOGY, I HAVE TO SAY THEY'RE AT A VERY EARLY STAGE BUT THERE IS A FAIR AMOUNT OF MOVEMENT BACK AND FORTH BETWEEN RWANDA AND UGANDA THESE DAYS BECAUSE THERE ARE MANY MORE FLIGHTS AND SOME EXCHANGES AND MORE UTILIZATION OF I.T. RESOURCE INDEED RWANDA, CAN HAS THE SERIOUS PROBLEM WITH RESPECT TO ECONOMIC GROWTH BECAUSE OF ITS HIGH POPULATION DENSITY IS INVESTING QUITE HEAVILY IN INFORMATION TECHNOLOGY AND UGANDA IS EXTREMELY WELL WIRED. SO THE UFILLIZATION OF THE--UTILIZATION OF THE TOOLS OF MOBILE HEALTH AND EXCHANGES THROUGH THE INTERNET TO IMPROVE SOME OF THE ASPECTS OF CANCER CARE SUCH AS PATHOLOGY AND THE DRUG SELECTION AND OTHER ASPECTS COULD BE MADE PRETTY EFFICIENT OF APPROPRIATE USES OF ELECTRONIC DEVICES. I'VE BEEN GIVING THOUGHT TO WHAT THE BSA SHOULD DO IN THE FUTURE, EVERY TIME WE HAVE A MEETING WE SEEM TO BE RUSHING TO FIND TOPICS AT THE LAST MINUTE BUT I'M I'M TRYING TO DO FORWARD THINKING ABOUT THIS, AND TRYING TO IDENTIFY TOPICS THAT ARE NOT CLOSELY LINKED TO THE RFAs THAT YOU'RE OBLIGED TO APPROVE HERE. --WOULD BE TAKING DETAILED STUDIES BY SUBCOMMITTEES THAT INCLUDE BOTH BSA MEMBERS AND AND ONE TOPIC THAT I THINK'S EXTREMELY IMPORTANT TO GET ENGAGED IN IS THE OVERALL GENOMICS EFFORTS AS YOU MAY REMEMBER FROM LAST TIME IF YOU ARE AN EXPERIENCED MEMBER OF THE BSA, BARBARA FROM CALTECH IS NOW RUNNING THE CANCER GENOMICS IS A VISITOR AND BRINGING TOGETHER THE OFFICIAL PROGRAMS WE HAD, CANCER GENOMEAT LAS PINTAS AND THE--GENOME ATLAS AND OTHER INITTATIVES THAT ARE CONDUCTS THROUGH--OR WON THROUGH COOPERATIVE AGREEMENTS AND VEHICLES AS WELL AS GENOMICS IN THE INTRAMURAL PROGRAM, TELL BE USEFUL TO HEAR ABOUT THIS, THE BRED OF OUR EFFORTS AND THE INTEREST WE HAVE IN MAKING THE PRODUCTS OF GENOMICS MORE USEFUL IN THE CLINICAL ENVIRONMENT. AND I'D ALSO LIKE TO TALK ABOUT THE TCGA PROGRAM, IS ONE THAT HAS BEEN WORKING INCREDIBLY EFFECTIVELY AT THE MOMENT BUT IT'S GOT GOALS AND ACHIEVE THOSE GOALS AND IT WILL BE CLOSED OUT AT SOME POINT, SO THE TOOLS THAT HAVE BEEN CREATED THROUGH THAT PROGRAM WILL LIKELY GO INTO A NEW PHASE OF UTILIZATION AND I THINK IT'S TIME TO THINK AS WE ARE THINKING AMONG THE LEADERSHIP AT THE NCI, AND WILL BE DISCUSSING I THINK IT'S NEXT WEEK, AT THE MEETING OF THE TCGA STEERING COMMITTEE, WHAT IS IS THE SCHEDULE, WHAT ARE WE GOING TO DO, WHEN WE ARE WE GOING TO CALL CLAIM, SUCCESS AND HOW ARE WE GOING TO TRANSFORM THIS EFFORT INTO THE NEXT STAGE OF WORK AND LARGE PART WILL BE TAKING ON SOME MORE BIOLOGICAL CLINICAL ISSUES THAT EMERGE FROM THE FINDINGS OF TCGA SO FAR AND ARE DIRECTED TO OUR SUBSTANTIATION OF THE PRINCIPLES THAT COME OUT OF TCGA IN THE CLINICAL PRACTICE. THIS MIGHT BE A USEFUL TIME TO MENTION A NEW REPORT FROM THE ACADEMY THAT I HOPE YOU HAD A CHANCE TO SEE, A REPORT CALLED TOURED PRECISION MEDICINE WHICH WAS WRITTEN BY COMMITTEE COMMITTEE CHAIRED BY SUSAN HELIOS POSITIVE MAN DESMOND BY UCSF AND CHARLES SAWYERS AND OF COURSE YOU ULTIMATELY KNOW BOTH OF THEM ARE ONCOLOGISTS BY TRAINING AND KARLZ IS STILL UPON AN ACTIVE CANCER RESEARCHER AND THIS REPORT WHICH IS INTENDED TO WORK OUR WAY OVER THE NEXT DECADE TO NEW MEANS OF DIAGNOSING AND CLASSIFYING DISEASE BASED ON THE PRINCIPLES OF MOLECULAR BIOLOGY AND GENOMIC IS I THINK PARTICULARLY PERTINENT TO SOME ASPECTS OF WHAT WE DO AT THE NCI. AND I THINK WE MIGHT GIVE SOME TIME AND SUBSEQUENT MEETING TO CONSIDERATION OF THIS REPORT AND HOW THE RESEARCH IS CONDUCTED BY THE NCI, OUGHT TO BE CARRIED OUT IN THE LIGHT OF THAT REPORT WHICH TALKING ABOUT HOW WE SHOULD BE AGGREGATING INFORMATION, CREATING INFORMATION COMMENTS AND THEN COLLEGE NETWORKS THAT INFLUENCE THE WAY IN WHICH WE DIAGNOSE DISEASES THAT HAVE TRADITIONALLY BEEN DIAGNOSED BY MICROSCOPIC EXAMINATION AND NOW INCREASINGLY ARE SUB DIVIDED BY THE KIND OF MOLECULAR TOOLS THAT ARE, OF COURSE MOST COMMONLY DEPLOYED IN THE TCGA. ANOTHER TOPIC I'M INTERESTED IN PURSUING IN THE CONTEXT OF THIS GROUP IS BIOMARKER ISSUE. WE HAVE MANY INITIATIVES HERE THAT ARE ADDRESSED TO ISSUES OF BIOMARKERS AND ED HARLOW WHO YOU WILL REMEMBER IS WORKING HERE THREE DAYS A WEEK GIVING ME ADVICE ON A VARIETY OF THINGS THINGS AND PROVOCATIVE QUESTIONS AND PAYING PARTICULAR ATTENTION TO THE BIOMARKERS ISSUES AND AND THEY ARE IN PARTICULAR HAVE BEEN HEAVILY INVOLVED IN SOME OF THESE PROGRAMS AND I'D LIKE TO HAVE SOME DISCUSSION OF THE MULTIPLE PROGRAMS WE'RE SUPPORTING AND HOW WELL THEY'VE BEEN DOING AND WHETHER WE CAN FIND--WHETHER WE SHOULD FIND OTHER WAYS TO SUPPORT THIS VERY IMPORTANT ACTIVITY. ANOTHER THING WE ARE ENGAGED IN TRYING TO STUDY IN GREATER DEPTH AND TEAM SCIENCE. THAT IS SCIENCE IS CONDUCTED BY MULTIPLE PIs EITHER THROUGH POONES OR COOPERATIVE AGREEMENTS OR OTHER SPECIAL PROGRAMS OR GRANTS AND WE ARE GOING TO HAVE A WORKSHOP ON THIS TOPIC PULLING IN PEOPLE FROM BETH THE IN CI SUPPORTED COMMUNITY AND ALSO PEOPLE WHO HAVE BEEN SUPPORTED BY INITIATIVES LIKE STAND UP TO CANCER AND HOWARD HUGHS AND OTHERS TO SEE WHETHER WE CAN FIND SOME INSTANCES OF TEAM SCIENCE THAT WORK PARTICULARLY WELL AND MIGHT BE PARTICULARLY APPLICABLE TO THE KINDS OF THINGS THAT WE'RE TRYING TO DO AT THE NCI. AND WE MENTION ONE OTHER THING AND THEN TURN IT OVER BRIEFLY TO MY COLLEAGUES TO MY RIGHT. LAST WEEK WE HAD A MEETING IN ONE OF THESE ROOMS, ORGANIZED BY FRANCIS COLLINS AND TWO OF HIS COLLEAGUES FROM INDUSTRY, TO TALK ABOUT WHETHER NIH AND INDUSTRY COULD FORM CLOSER TIES IN THE DOMAIN OF WHAT'S CALLED TARGET VALIDATION, SOME MIGHT CALL IT TARGET QUALIFICATION OR TARGET DISCOVERY, BUT, THE BASIC IDEA IS WHETHER GIVEN ALL THE POTENTIAL WE ALL BELIEVE IS HAS NOW BEEN CREATED BY MODERN MOLECULAR BIOLOGY TO DO A BETTER JOB IN DRUG DEVELOPMENT THAT THE DRUG DEVELOPMENT HAS BEEN LESS SUCCESSFUL BY MOST MEASURES THAN MIGHT HAVE BEEN ANTICIPATED AND THE EXTENT TO WHICH WE COULD IMPROVE THAT PROCESS BY SHARING INFORMATION, EVEN COLLABORATING IN THE SO CALLED PRECOMPETITIVE SPACE, I HATE THE PHRASE BUT YOU GET THE IDEA IN THE DOMAIN BEFORE THAT'S BEFORE THE DISCOVERY AND PATTENING OF ACTUAL DRUG CANDIDATE THERE IS IS A REALM OF ACTIVITY THAT INCLUDES PACIFYING POTENTIAL TARGETS BUT IMMUNE ANTIBODIES AND STRATEGIES AND GET FOLKS TO SHARE THAT INFORMATION AND GO ON OFF ON THEIR OWN AS PRIVATE COMPANIES TO TRY TO DEVELOP PRODUCTS THAT ARE MORE EFFECTIVE WAYS TO TREAT DISEASE OR PREVENT DISEASE. IN THIS CONTEXT OF COURSE, CANCER HAS TO PLIE A SIGNIFICANT--PLAY A SIGNIFICANT ROLE, THAT'S WHERE THEY'RE COMING AND IN THE CONTEXT OF THE MEETING THAT WAS CONDUCTED LAST WEEK, THE PURVIEW WAS MUCH BROADER AND REALLY ADDRESSED ANY DISEASE THAT MIGHT BE UNDERSTOOD BETTER BECAUSE WE HAVE A BETTER PICTURE OF THE GENOTYPE AS EMERGING FROM GWAS STUDIES AND HIGH THROUGH PUT SEQUENCING STUDIES AND THE FACT OF UNDERSTANDING PHENOTYPES BETTER AS A RESULT OF MORE ELABORATE PHENOTYPING AND THEN FOLLOW UP OF GENOTYPING SO THAT THERE WERE TWO OTHER PROPOSALS THAT EMERGED. ONE ON GENOTYPES TO PHENOTYPES AND ANOTHER PHENOTYPES TO GENOTYPES BUT THERE WAS ALSO AN AGREEMENT AROUND THE TABLE THAT THERE WOULD BE AN ONCOLOGY EFFORT, SOME CALLED IT CANCER EXPLORATION OR GOOGLE CANCER IN WHICH THE--THE CANCER COMMUNITY THAT WAS COMPOSED OF FOLKS IN THE NOT FOR PROFIT GOVERNMENT ACADEMIA SECTOR AND FOLKS IN THE FOR PROFIT SECTOR, MAINLY FROM LARGE PHARMA BUT ALSO FROM BIOTECH WOULD MIGHT GET TOGETHER AND EXPLORE WHAT COULD BE DONE AND I'VE ASKED JIM DOROSHOW TO HELP ME PLAN A STEERING COMMITTEE WHICH TODD I BELIEVE HAS GRACIOUSLY AGREED TO SERVE, AND WITH PURPOSES FROM OTHER ADVISORY GROUPS AS WELL TO CONSIDER SOME OF OUR OPTIONS AND PULL TOGETHER A WORKSHOP OVER THE NEXT FEW MONTHS TO TALK ABOUT WHAT CANCER RESEARCH COMMUNITY COULD DO, IF ENLARGED TO INCLUDE BOTH FOR PROFITS AND NOT FOR PROFITS TO SEE WHETHER THINGS RAIN FROM DATA AGGREGATION AND OPEN SITE TO ACTUAL COLLABRATIVE RESEARCH MIGHT BE HELPFUL AND ACCELERATING OUR EFFORTS TO FIND BETTER WAYS TO PREVENT AND TREAT CANCER. SO THOSE ARE THE TOPICS ON MY LIST. I WANT TO MENTION THE MEET NOTHING TORONTO--MEETING IN TORROANT O? >> I WANT THE TO TAKE A FEW SECONDS TO FIRST THANK DR. STEIN FOR ALLOWING ME TO ATTEND A STRATEGIC RETREAT IN TORONTO AT THE ONTARIO INSTITUTE FOR CANCER RESEARCH AND THE REASON I WANT TO MENTION IT IS THAT ALL THE TOPICS THAT WERE DISCUSSED AND THE ATTENDEES FOR THOSE INSTITUTIONS THAT SOME OF THOSE INSTITUTIONS THAT ALREADY HAVE CLINICAL DENATIONAL LIBRARY OF MEDICINICS EFFORTS--CLINICAL GENOMICS EFFORTS AND THE WHOLE IDEA WAS TO DISCUSS THESE FROM INSTITUTION AND INSTITUTION COULD ACTUALLY BE DONE BETTER AND HOW DO WE MOVE FROM THINKING THROUGH WHAT TECHNOLOGIES ARE AVAILABLE TODAY AND WHAT ARE THE BEST THAT ARE GOING TO BE AVAILABLE AND ALSO IN THE NEAR TERM, HOW DO WE HANDLE THE TISSUES, ESPECIALLY THE REPEAT BIOPSIES THAT ARE REQUIRED. CAN WE USE FIXED TISSUES OR NOT, WHAT EFFORT WILL IT TAKE TO GET TO THAT PLACE, THE REGULATORY ISSUES, HOW DO YOU CURATE THESE SMALL BIOSPECIMENS THAT MAY NOT HAVE CANCER IN THEM, HALF THE TIME AND CLINICAL DECISIONS THAT NEED TO BE MADE AROUND THOSE. AND THEN, A LOT OF TIME WAS SPENT AND I'M REALLY VERY APPRECIATIVE OF THE CHANCE TO PARTICIPATE IN THIS ABOUT HOW TO MANAGE ALL OF THIS DENATIONAL LIBRARY OF MEDICINIC INFORMATION BECAUSE NOW THERE ARE HALF A DOZEN AND DOZEN INSTITUTIONS AND COLLECTING MUTATIONAL SPECTRA ON DISEASES IN GENES THAT ARE NOT NOW THOUGHT TO BE TARGETS IN THOSE DISEASES AND YET WHAT'S KNOWN IN BOSTON IS NOT NECESSARILY WHAT'S KNOWN IN LOS ANGELES OR CHICAGO OR OR WHEREVER. SO THE QUESTION ISŤ— HOW DO WE OR CAN WE AGGREGATE THAT INFORMATION FOR THE GREATER CANCER COMMUNITY. THERE IS NO--AND DO IT IN THE CONTEXT OF HAVING CLINICAL INFORMATION THAT WOULD INFORM THAT--AND THEN NOT LAST BUT CERTAINLY NOT LEAST THERE, REALLY IS ONLY THE BEGINNINGS OF DISCUSSIONS AROUND THE COUNTRY ABOUT HOW DO YOU CLINICAL TRIAL WHEN IS HAVE YOU THIS INFORMATION. IT'S NOT IMMEDIATELY OBVIOUS, THERE ARE MANY POSSIBILITYS AND I WANT TO MENTION THIS HAD RETREAT NOT ONLY BECAUSE IT WAS AN EXCELLENT OPPORTUNITY TO DISCUSSION THESE ISSUES BUT BECAUSE I THINK ALL OF THE THINGS THAT I'VE JUST MENTIONED ARE GOING TO COME BACK TO THIS COMMITTEE BECAUSE WE'LL HAVE TO FIND A WAY TO SUPPORT RESEARCH IN EACH OF THOSE AREAS TO USE THE INFORMATION THAT'S BEEN GENERATED. >> SO TODAY? >> SURE. >> SO QUESTIONS FOR ANY THREE OF US? YES? >> BETTY FARRELL FROM CITY OF HOPE, I WANT TO COMMENT ON YOUR EARLIER REMARKS ABOUT YOUR OUTREACH TO THE GLOBAL COMMUNITY AND FOR THE LAST 10 YEARS I'VE BEEN A PART OF SIGNIFICANT EFFORTS IN INTERNATIONAL OUTREACH FOR PALLAATIVE CARE AROUND THE WORLD AND I JUST CAME BACK AT MIDNIGHT FROMBLE EASE WHICH IS OF--BELEES AND DR. CATHY FOULY HAS BEEN INVOLVED SO IN EACH OF THESE COUNTRIES MANY THAT ARE DEVELOPING OR LAUNCHING CANCER CENTERS, WE'RE REALLY LAUNCHING THEIR EFFORTS, INITIATING CLINICAL TRIALS OR TREATMENTS, BECAUSE OF THE EXTENT OF LATE DISEASE, THERE'S ALSO SUCH A TREMENDOUS OPPORTUNITY TO EXTEND PAIN MANAGEMENT PALLIATIVE CARE EFFORTS, PHYSICIANS, NURSES, MINISTERS OF HEALTH ARE EXTREMELY EAGER TO LEARN FROM THE ADVANCES IN THE UNITED STATES, SO I'M REALLY EAGER TO HEAR MORE ABOUT THAT, BUT ALSO TO THINK OF OF OPPORTUNITIES THAT WHILE WE ARE SUPPORTING THESE COUNTRIES AND ADVANCING CANCER CARE WE CAN REDUCE THE BURDEN OF CANCER AS WELL. >> YEAH, THANK YOU VERY MUCH. >> YOU WILL HEAR MORE FROM TED TRIMBLE ON THIS TOP AND I CAN PALLIATION HAS BEEN A MAJOR TOPIC OF CONVERSATION, NOT JUST AMONG THOSE OF US IN THE U.S., BUT AT THE MEET NOTHING LONDON, I MENTIONED THERE WAS A LOST ATTENTION PAID TO SYMPTOM CONTROL IN GENERAL AND OF COURSE, THE RELOCKETTANCE TO USE OPIATES IS REALLY STRIKING IN MANY COUNTRIES AND EVEN PEOPLE HAVE VERY ADVANCED CANCER AND NEED TO DO SOMETHING ABOUT THAT BECAUSE THESE DRUGS ARE NOT THAT EXENSIVE. --EXPENSIVE. THANK YOU. ANYTHING ELSE? >> HERB? >> SO THIS IS JUST ON THAT QUESTION OF TEAM SCIENCE. SOMEBODY'S GOING TO REPORT ABOUT IT TODAY? >> NOTHING'S GOING TO BE SAID ABOUT IT TODAY. THERE IS A WORKSHOP WE'RE PLANNING THAT WILL INCLUDE FOLKS FROM A VARIETY OF DOMAINS, THE OHM POINT I WANT TO MAKE IS THAT, THERE'S AN EXPERIMENT GOING ON IN CALIFORNIA, THROUGH PROP 71, SO CALIFORNIA'S REGENRATIVE MEDICINE WHERE THEY PUT OUT A CALL FOR APPLICATION TO FORM DISEASE]/> TEAMS. NOW THE INTERESTING THING ABOUT THAT IS, THEY'RE ASKING ACADEMICS OR SMALL COMPANIES OR EVEN COMBINATIONS TO DO THAT, SO IT'S--IT'S A GRASS ROOTS METHOD OF PEOPLE FOR THE FIRST TIME COMING TOGETHER AND THEN COMING TO GRIPS WITH THE ISSUE THAT THERE ARE TASKED TO BE ABLE TO TAKE DISCOVERY THEY'VE ALREADY„i MADE. AND ALREADY HAVE SOME PRECLINICAL PROOF OF PRINCIPLE INTO SOMETHING THAT COULD BE FILED AS AN I& D. AND IN THAT EFFORT, THEY LEARN MANY NEW THINGS AND IT'S OF COURSE COMING FROM THE PEOPLE WHO MADE THE DISCOVERIES AND THE BIGGEST PART OF IT IS THAT SERM IS REQUIRED TO FUND SOME OF ITS LEADING DISCOVERIES WHETHER IT'S IN CANCER, REGENERATIVE MEDICINE THROUGH THE PHASE ONE-TWO TRIAL. SO IT'S A VERY INTERESTING MECHANISM THAT I SEE HAVING--IT'S AN EXPERIMENT OF COURSE THERE WILL BE FAILURES BUT IF THERE ARE SUCCESSES, I THINK IT'S A DIFFERENT WAY OF THINKING ABOUT HOW TO GET INFORMATION FROM THE GRASS ROOTS AND HOW TO REALLY FORM A NIGHTUS OF PEOPLE LEARNING WHAT IT IS OR GETTING READY FOR THE CLINICAL TRIALS. >> WE WILL ADD SERUM TO THE LIST BECAUSE ONE OF THE THINGS WE'RE INTERESTED IN THIS THE EXERCISE IS WHAT ARE THE INCENTIVES FOR GETTING PEOPLE TO WORK TOGETHER. SO WHEN YOU JUST SAY THERE'S MONEY ON THE TABLE IF YOU WORK TOGETHER, THAT'S NOT AS COMPELLING AS SAYING, HERE'S A HIGHER REASON, HERE'S WHAT WE THINK MIGHT ACTUALLY WORK. AND SO, THIS IS--IT SOUNDS LIKE A GOOD EXAMPLE AND WE'LL DO SOMETHING ABOUT IT. JOE? >> YEAH, CONTINUING ON THAT THEME, ORGANIZED A MEETING A FEW WEEKS BACK AND INVITED PIERRE ODONEY TO GIVE A KEY NOTE TALK ON LESSONS THAT BIOLOGISTS COULD LEARN FROM PHYSICS, SO PIERRE IS CURRENTLY THE DIRECTOR OF PERMY LAB AND HAS PARTICIPATED HISTORICALLY AND SCERNEAND LACK AND BIG EXPERIMENTS AND I THOUGHT HE GAVE AN INTERESTING TALK AND I THINK THERE ARE A LOT OF LESSONS FROM PHYSICS THAT GENERICALLY COULD BE BROUGHT TO BEAR. >> HE'S ALREADY GOT THE TALK. >> GOOD, I HOPE SOMEONE WHO HELPED US ORGANIZE IS THAT MAUREEN IS TAKING NOTES AND WE'LL--THAT'S A REALLY GREAT IDEA BECAUSE ONE OF THE ISSUES HERE IS THE MULTIDISCIPLINARY SIDE OF THINGS AND SO THAT WOULD BE QUITE AN INTERESTING ONE TO PURSUE. >> TWO THINGS. ONE BIG ABNORMALITIES STACKLE TO TEAM SCIENCE SPECIAL RECOGNITION FOR THE TENURE SYSTEM AND WHILE THE RECOGNITION PROBLEM HAS BEEN PARTIALLY SOLVED BY HAVING MULTIPI INVESTIGATOR ROLES WHERE ALL INVESTIGATORS CAN GET CREDIT, THE LEVEL OF THE PUBLICATION IS STILL A THORNY ISSUE AND SO I THINK THIS IS SOMETHING WHERE THE NCI COULD POETIC TECTIALLY LEAD IN TERMS OF BASICALLY GIVING--YOU SOMEONE KIND OF INDICATION OF HOW MULTIPI, PUBLICATIONS AND SENIOR PUBLICATIONS SHOULD BE ADDRESSED. >> LET ME SAY A FEW THINGTHAT. >> ONE OBVIOUS ANSWER IS NOT A VERY SATISFACTORY ONE THAT, IS MORE FOOT NOTES, AND MORE TIRED OF SAYING THESE EIGHT PEOPLE ARE CO FIRST AUTHORS AND THESE FOLLOWING SIX PEOPLE ARE CODES, THE SENIOR AUTHORS, I THINK THIS--ONE OF THE THINGS THIS COMES TOO IS THE INITIATIVE THAT EVOLVES AROUND HOW WE PORTRAY OURSELVES AND GETTING AWAY FROM TRADITIONAL CVs TO A BIOSKETCH THAT'S MORE MEANINGFUL AND I'VE BEEN PUSHING ON BUILDING ONE AS WE CALL IT TO TRY TO DO SOMETHING ABOUT THE NIH BIOSKETCH AND WE'RE DISCUSSING THIS AT AN NIH DIRECTORS MEETING THE NEXT COUPLE OF WEEKS. MY OWN VIEW IS THAT THE BIBLIOGRAPHY--THE CENTER BIBLIOGRAPHY SHOULD BE SUPPLEMENTARY INFORMATION TO THE BIOSKETCH AND THE BIOSKETCH SHOULD BE CENTERED AROUND SCRIEWKS TO SCIENCE AND SHEA SHOULD BE ALLOWED TO OF COURSE AUTHENTICATE THE CLAIMS BY SITING PAPERS BUT THEY SHOULD BE--THE BIOSKETCHES SHOULD BE WRITTEN IN A WAY THAT SAYS, HERE'S WHAT I'VE DONE, THE CONTEXT OF A PROJECT, HERE'S WHY WE DID IT, HERE'S WHAT WE DID, HERE'S WHAT THE CONSEQUENCES HAVE BEEN SO THAT SOMEBODY CAN READ A ONE OR TWO PAGE SUMMARY OF A PERSON'S CONTRARY CAREER IN A WAY THAT REFLECTS THE ACTUAL CONTRIBUTIONS OPPOSE TO WHAT POSITION THEY WERE IN, THE AUTHORSHIP, THE PAPER WAS PUBLISHED AND HOW MANY CITATIONS, HOW MANY HITS ON THE WEB SITE, BUT--BUT A MORE QUALITATIVE ANALYSIS OF ONE'S OWN CONTRIBUTIONS AS A SCIENTIST NEED TO BE DEVELOPED TO REPLACE WHAT I THINK IS A REALLY WEAK TOOL FOR DECIDING HOW WELL SOMEONE'S DONE BASED ON THE NUMBER OF FIRST OR LAST AUTHOR PUBLICATIONS AND CERTAIN JOURNALS AND YOU KNOW WHICH ONES THEY ARE. SO I THINK THAT'S REALLY VALUABLE BUT SOMETHING THAT COULD BE VERY HELPFUL IS SOME KIND OF A OF AN ARTICLE PUBLISHED BY THOUGHT LEADERS ABOUT HOW SCIENCE IN SOME CASES ACTUALLY CHANGING RIGHT NOW AND PHIS CYST VS DONE THIS AND PAY PUBLISH ALPHABETICALLY AND PEOPLE KNOW WHAT YOU'VE DONE, AND I THINK THAT HAVING THAT KIND OF SORT OF THOUGHT LEADERSHIP IN HAVING, I DON'T KNOW--SOME KIND OF WHITE PAPER TYPE ARTICLE-- >> I NEVER KNOW WHAT THEY THOUGHT LEADER IS, BUT YOU'RE A SMART PERSON, CAN YOU WRITE IT. >> I MAYBE WE SHOULD CO-AUTHOR. >> THE SECOND THING I WANT TO SAY ABOUT THE INTERACTION WITH INDUSTRY, RIGHT NOW--SO GSK, AND PFIZER NOW, STARTED TO OUTSOURCE SIGNIFICANT AMOUNT OF THEIR RESEARCH PORTFOLIO TOO ACADEMIA SO I THINK THIS IS REALLY THE PERFECT TIME TO DO THIS KIND OF OPERATION WE JUST MENTIONED. >> YEAH. >> SO HAROLD, I WANT TO COME BACK TO THE BUDGET. I THINK MOST OF US ARE GOING TO SURVIVE ONE WAY OR THE OTHER THE CURRENT BUDGET ENVIRONMENT BUT WHAT I'M MOST CONCERNED ABOUT IS THAT THE NEXT GENERATION OF CANCER RESEARCHERS IS GOING TO LOOK AT THIS AND SAY, WHAT KIND OF A CRAZY SYSTEM IS THIS CONTINUING RESOLUTIONS AND YOU KNOW SPENDING POWER GOING DOWN AND SO ON. >> I SHOULD GO DO SOMETHING ELSE. >> IS THERE A ROLE OF THE NCI TO THE ROLL OF THE NCI IN TRYING TO PREVENT THAT NEXT GENERATION OF SCIENTISTS FROM EVAPORATING. >> WELL, THERE ARE TWO ISSUES HERE, TODD, ONE OF COURSE IS MANAGING THE BUDGET WE GET IN A WAY THAT PROVIDES SOME PROTECTION FOR EARLY STAGE INVESTIGATORS AND WE ARE TRYING TO MAINTAIN TRAINING STIPENDS, THE NUMBER OF POSITIONS IN TRAINING, OF COURSE AS YOU KNOW THE NCI OR NIH IS NOT THE MAJOR SOURCE OF FUNDS FOR TRAINING BUT WE DO SET THE STANDARD AND WE DO SET THE SIGNALS AND I THINK MOST OF US FEEL THIS IS STILL AN INCREDIBLY EXCITING AREA IN WHICH TO WORK AND WE DO WANT TO ATTRACT THE VERY BEST PEOPLE. THE SECOND ASPECT OF MANAGEMENT OF COURSE IS GRANTS MANAGEMENT AND WE WILL CONTINUE TO INSURE THAT EARLY STAGE INVESTIGATORS ARE AS SUCCESSFUL AS EXPERIENCED INVESTIGATORS IN THE GRANTS PROCESS. I THINK IT WOULD BE A MISTAKE TO SAY, WE'RE JUST GOING TO FUND EARLY STAGE INVESTIGATORS, NOT EXPERIENCED PEOPLE, THAT WOULD BE SHOOTING OURSELVES IN THE FOOT. AND THE FACT IS THAT YOU CAN'T--MONEY IS NOT ELASTIC. I MEAN WE CAN'T CREATE SOMETHING WE DON'T HAVE, CAN'T PRINT OUR OWN MONEY SO EVENTUALLY, THIS ARGUMENT HAS TO BE BROUGHT TO THE PUBLIC AND TO CONGRESS AND THAT'S SOMETHING THAT WE CERTAINLY TRY TO DO IN THE NCI, I WOULD LIKE THE ADVOCACY GROUPS TO BE OUT THERE POUNDING ON DOORS A BIT MORE. THE COUNTRY IS IN DIRE ECONOMIC SITUATION AND IT'S KNOTS SIMPLE TO GET PEOPLE'S ATTENTION THESE DAYS TO THIS ISSUE BUT I CAN--I'VE MENTIONED BEFORE THAT THERE WERE SOME--A FEW OPPORTUNITIES LAST YEAR TO MAKE POINTS MORE FORCEFULLY AND IT DIDN'T HAPPEN WHEN WE WENT TO CONGRESS. THE SOLE APPROPRIATION CHAMBER HEARING WE HAD IN EITHER CONGRESS WAS OUR SENATE HEARING LASTED TWO HOURS BUT IT WAS A GOOD ONE. NO HEARING IN THE HOUSE BUT SENATE HEARING, 2/3RDS OF THE SEATS WERE EMPTY. THAT WAS A BAD SIGNAL. AND THERE ARE OTHER WAYS IN WHICH I'VE BEEN ARGUING STRONGLY THAT SCIENTIFIC COMMUNITY NEEDS TO INSURE THAT EVERY DELEGATE TO CONGRESS HEARS WHAT IS HAPPENING TO ONE OF THE GREAT INSTITUTIONS IN THE U.S. AND THAT MEANS GOING TO THE HOME OFFICE WHEN MEMBERS OF HOME, AND SITTING DOWN AND SPENDING TIME INTRODUCING THE MEMBERS OF CONGRESS TO SMART YOUNG INVESTIGATORS WHO'VE BEEN TRAINED WITH NIH MONEY AND ASPIRE TO PRODUCTIVE CAREERS IN MEDICAL SCIENCES AND ISN'T HAPPENING ON THE SCALE IT NEEDS TO HAPPEN ON. >> YEAH, ONE OF THE MOST INTERESTING THINGS THAT CAME OUT OF THE PHYSICS LECTURE IS HOW IT IS THAT THE PHYSICS COMMUNITY HAS FIGURED OUT HOW TO INCENTIVIZE FUNDING AGENCIES AROUND THE WORLD ISSUES, HOW YOU ELEVATE A SCIENTIFIC IDEA TO SUCH PROMINENCE THAT IT BECOMES ALMOST A NATIONAL IMPERATIVE TO FUND IT AND THERE'S REAL LESSONS IN THERE THAT I THINK ARE DIRECTLY RELEVANT TO WHAT TODD WAS GETTING AT, THEY DO IT A DIFFERENT WAY. >> I HEAR MORE ABOUT THAT. MY COLLEAGUES AND PHYSICS COMPLAIN BITTERLY THAT PHYSICS HAS BEEN IGNORED AND ALL THE MONEY'S GOING TO BIOMEDICAL RESEARCH IN THE LAST 30 YEARS AND SO, I'VE BEEN CURIOUS TO HEAR ABOUT ALL THESE SUCCESSES BECAUSE I'VE SPENT SOMETIME WORKING WITH THE PHYSICS COMMUNITY TRYING TO HELP THEM GET--AND PART OF THE SUCCESS HAS BEEN RECENTLY THE PAYING INCREASING ATTENTION TO THE IMPORTANCE OF PHYSICS AND BIOMEDICAL RESEARCH. >> SURE, BUT, THE POINT IS THAT OUR SYSTEM A LOT EASIER CELL. --SELL. >> YEAH. >> THEY'VE BEEN SUCCESSFUL AT SELLING PRETTY ARCANE IDEAS AND SUSTAINING THE FIELD. >> AND ALSO OF--ONE OF THE THINGS THAT'S BEEN PROBLEMATIC IN PARTICLE PHYSIC SYSTEM THE FAILURE OF THE SUPPORT, VERY IMPORTANT INITIATIVES AND FEEDING MUCH DOMINANCE IN PARTICLE PHYSICS TO EUROPE. >> I'M GOING TO SUGGEST WE NEED TO MOVE ON TO THE NEXT ORDER OF BUSINESS. I'M SURE WE'LL COME BACK TO MANY OF THESE DISCUSSION POINTS IN FUTURE MEETINGS. SO WE'RE NOW GOING TO MOVE TO A REPORT FROM THE caBIG OVERSIGHT COMMITTEE WHICH IS CHAIRED BY DAN MASYS AND IT'S FAIR TO SAY, IT'S MORE COMPLICATED SCIENTIFICALLY, AND MORE PEOPLE IN THE RESEARCH COMMUNITY REALLY APPRECIATE SO IT'S A BIG CHALLENGE FOR THE SUBCOMMITTEE TO TRY TO ADVISE AND WEIGH-IN ON WHAT caBIG SHOULD BE FOCUSING ON. SO WE'LL GET AN INTERIM REPORT TODAY. >> THANK YOU TODD AND SO, SINCE YOU LAST MET, WE WANTED TO SHOW YOU THE PROGRESS MADE IN RESPONSE TO THE MARCH REPORT OF THIS YEAR AND LET ME PROVIDE CONTINUITY TO THAT TO SHOW YOU THREE SLIDES THAT YOU WERE SHOWN IN THE DISCUSSION IN THE caBIG EVALUATION REPORT. THEY INCLUDED CONCLUSION AT THE POP OF THE LIST THAT SUPPORT FOR CLINICAL INFORMATICS RULES AND ALEGORITHMS ADVANCE SYSTEM CRITICAL FOR THE NCI AND SO LET ME PUT AN EXPOLICEMANNATION POINT ON THAT BY SAYING THAT OUR COMMITTEE AND THIS REVIEW GROUP, I THINK WAS OF THE OPINION THAT IF SOMETHING LIKE caBIG DID NOT EXIST IN 2011, YOU WOULD HAVE TO INVENT IT, SO THE FUNDAMENTAL FUNCTIONAL REQUIREMENTS REMAIN INTACT AND IN PLACE AND ARE ESSENTIAL TO THE MISSION OF THE NCI. THERE WAS AS A RESULT OF THAT REVIEW, EVIDENCE OF STRONG COMMUNITY SUPPORT FOR THE ORIGINAL caBIG VISIONS AND GOALS THAT THERE WERE A NUMBER OF caBIG SUCCESSES AND THEY WERE HOWEVER OFFSET BY SOME PROBLEMS THAT THE OVERALL IMPACT OF THE DOLLARS SPENT WAS NOT COMMENSURATE WITH THE LEVEL OF THE INVESTMENT. THE MAIN PROBLEMS FOUND BY THE REVIEW GROUP AS WRITTEN IN THAT REPORT AND PRESENTED WERE A CART BEFORE THE HORSE GRAND VISION THAT WAS IN MANY CASES TECHNOLOGY CENTRIC RATHER THAN USER NEED CENTRIC SOMEWHAT UNFOCUSED EXPANSION, ONE-SIZE-FITS-ALL APPROACH IN SOME AREAS AND UNSUSTAINABLE BUSINESS MODEL IN THE SENSE OF CREATING APPLICATIONS THAT WOULD NEED SOFTWARE SUPPORT AND CONTINUING ENHANCEMENT AND SIMPLY NO REASONABLE EXPECTATION. THERE WOULD BE ENOUGH MONEY TO FUND ALL OF THOSE THINGS AS THEY GREW OVERTIME. I WAS AN ASSOCIATE DIRECTOR OF THE NATIONAL LIBRARY OF MEDICINE AND DON LIMBURG IS SAY SYSTEMS GET USED, GET BETTER AND SO, IF ALL OF THE caBIG SYSTEMS HAD GOTTEN USED THEY WOULD HAVE t. ENHANCEMENT REQUIREMENTS THAT SIMPLY WOULD NOT HAVE BEEN SUSTAINABLE AND THEN THERE WAS THE LAST SCIENTIFIC OVERSIGHT, AND THAT'S WHY WE AS A SUBCOMMITTEE OF THE BSA WERE CREATED. SO THESE WERE THE IMMEDIATE TECHNICAL RECOMMENDATIONS. THIS IS FROM THEY PORT INSTITUTE AND THE IMMEDIATE MORATORIUM AND ONGOING INTERNAL AND COMMERCIAL CONTRACTOR BASE SOFTWARE DEVELOPMENT WHILE MITIGATE TAG, THAT IS ATTENTION TO NOT HAVING THAT MORATORIUM SEVERELY ADVERSELY IMPACT THE CANCER RESEARCH COMMUNITY, TO INSTITUTE A ONE YEAR MORATORIUM ON NEW THINGS WHILE THE OLD THINGS WERE KIND OF REFOCUSED AND PRUNED. PROVIDED ONE YEAR EXTENSION ON caBIG SUPPORTED ACADEMIC EFFORTS RECOGNIZING THAT MANY OF THE MOST SUCCESSFUL EFFORTS AND TOOLS HAD BEEN GRASS ROOTS BOTTOM UP INITIATIVE OF ACADEMIC INVESTIGATORS IN ACADEMIC SETTINGS, FORCED TO ESTABLISH THE OVERSIGHT COMMITTEE THAT I'M REPORTING ON AND FIFTH DO TOR DO AN AUDIT OF THE CAIRCRAFT BIG ODD AND IT EXPENDITURES. SO THE IMPORTANT HIGH LEVEL CONTEXT SET FOR ALL OF THIS IS SHOWN ON THIS SLIDE WHICH IN THE BLUE AREA SHOWS THE caBIG PROGRAM EXPENDITURES MINUS THE ARRA FUNDING FOR 2008 AND 2009 AND 10 AND 11 AND YOU'LL SEE THE PROGRAM PEEKED IN 2000--PEAKED IN 2009 AND IT DROPPED TO 47 IN 2010 AND THAT WAS SUBSTANTIALLY OFFSET BY THE CONCURRENT AVAILABILITY OF ARRA FUNDING AND THEN, YOU SEE THE NUMBER FOR 2011. SO THAT IS A VERY SUBSTANTIAL DECREASE IN THE TOTAL POOL OF FUNDS AVAILABLE FOR caBIG PROGRAMS AND PROJECTS. YOU SEE THE ARRA FUNDING WHICH ALSO ADJUST INDEED RESPONSE TO THE MARCH REPORT, ALL OF WHICH HAS BEEN EXPEPPEDDED SO OUR COMMITTEE HAS NOT SPENT A LOT OF TIME WORRYING ABOUT THE BLIP CAUSED BY ARRA, BUT RATHER BY LOOKING AT THE BASELINE INFORMATICS COMMITTEE. WITH RESPECT TO THE COMMITTEE MARCH REPORT, THE COMMITTEE MEMBERSHIP WAS IDENTIFIED AND IT WAS AGREED AND WE MET FOR THE FIRST TIME FACE TO FACE JULY 25th IN CHICAGO AND SECOND FACE TO FACE MEETING WAS HERE IN BETHESDA AND WE HAD MONTHLY PHONE CALL MEETINGS WITH THE IDEA OF CREATING A SET OF OPERATING PROCEDURES THAT ARE EXPLICIT, TRANSPARENT, NOT IN ANY WAY COVERT, BUT THAT WE WOULD DO THIS IN A WAY THAT PEOPLE MIGHT DISAGREE WITH OUR OPINIONS BUT AT LEAST THEY WOULD KNOW THE CRITERIA WE USE TO COME TO THOSE OPINIONS. THIS IS A GROUP ROSTER, IT SHOWS WHAT I THINK IS A REMARKABLE LEVEL OF TEAM PARTICIPATION FROM A VARIETY OF DIFFERENT DISCIPLINES AND DIFFERENT APPROACHES TO DOING THIS AND YOU'LL NOTICE THAT AMONG OUR MEMBERS THAT ANDREA JOKED, AND LINCOLN STEIN OUR MEMBERS OF THE BSA SO THERE ARE STRUCTURING CONNECTIONS TO YOU AND YOU'LL SEE THE OTHER MEMBERS OF THE COMMITTEE THERE. I THINK WITH A BROAD RANGE OF EXPERTISE AND IS THIS THE CREATION OF REUSABLE INFRA STRUCTURE AND TARGETED APPLICATIONS AND BASIC WET BENCH CAMPER RESEARCH AND CLINICAL TRANSLATIONAL RESEARCH SO IT'S--IT'S GOT THE EXPERTISE, IT NEEDS AND FOR PURPOSES OF ACTUALLY DOING THE WORK OF PROJECT BY--PROJECT ASSESSMENT, WE DIVIDED OURSELVES INTO THREE WORKING GROUPS, THE FIRST IS BIOINFORMATICS AND BASIC CANCER RESEARCH. AND THE BASIC INFORMATICS AND CROSS CUTTING INFRASTRUCTURE. THE THINGS THAT ARE SORT OF PROTECT PERHAPS NOT THE--A SET OF PROJECT REVIEW CRITERIA TAKEN--THEY WILL BE WIDELY PUBLISHED, BOTH FOR CORRELATION WITH THE RECOMMENDATIONS WE MAKE BUT ALSO FOR THE FUTURE GUIDANCE OF caBIG AND I WANTED TO GO THROUGH THESE BECAUSE THEY INFACT SPEAK OF THE SPECIFIC FINDINGS OF THE MARCH REPORT. SO THE FIRST QUESTION WE WOULD ASK OF ANY caBIG PROJECT OR PROGRAM IS DOES THE ACTIVITY ASK RESOURCE MEETING ARTICULATE AN ATTAINABLE MEETING OF BASIC CLINICAL OR TRANSLATIONAL RESEARCHERS OR CANCER HEALTHCARE AND IN THIS REGUARD THE COMMITTEE HAS USED THE MODELS OF THE NATIONAL CENTERS FOR BIOMEDICAL COMPUTING WHICH ARE SUPPORTED BY NIH AND ALL OF WHICH HAVE BEEN SINCE THEIR INCEPTION REQUIRED TO HAVE DRIVING BIOLOGICAL PROJECTS THAT IS SCIENCE THAT HAS REAL NEEDS THAT NEED TO BE REALLY MET AND THIS WOULD BRING A BIG CRITERIA AS WELL. THE COMMITTEE IS STENSATIVE TO THE NOTION THAT LIKE CLINICAL PROTOCOL THERE SHOULD BE STOPPING THE RULES AND WE ALSO DO THINK THAT THERE SHOULD BE SOME THINGS THAT FAIL. THAT IF WE ARE SO CONSERVATIVE AND SO TIGHTLY BOUND TO THINGS THAT ARE KNOWN TO BE A GUARANTEED SUCCESS, THEN WE ARE NOT BEING ADVENTURESOME ENOUGH IN THE AREAS OF ALEGORITHMS DEVELOPMENT AND COMPUTATIONAL BIOLOGY AND COMPUTATIONAL INFRASTRUCTURE. AND THIRD REVIEW CRITERIA WOULD BE IF IT'S SUCCESSFUL WILL IT MAKE OBJECTIVELY MEASURABLE INCREMENTAL PROGRESS TOWARD CABIG AND DATA SYSTEM--THAT SPEAKS TO THE GENERAL NOTION THATTAGEILE SCIENCE--THAT AGILE SCIENCE IS LINKED THROUGH HIGH THROUGH PUT LABORATORY METHODS THAT MAKE IT POSSIBLE TO MEASURE THINGS THAT WE COULDN'T MEASURE A FEW YEARS AGO AND AS FRANCIS COLLINS IS FOND OF SAYING INCLUDING ALL OF OUR VISION OF WHAT WE CAN DO. THE ABILITY TO MEASURE ALL GENOTYPES, ALL FUNCTIONAL EXPRESSION, ALL POSSIBLE MOLECULAR PATTERNS OF INTEREST AND SO THIS AGILITY--THE SCIENCE HAS MOVED TO MORE NEW TECHNOLOGY SYSTEM IMPORTANT TO THE CRITERIA FOR REVIEW, THIS IS A COMMON SENSE ONE FOR ANY PROJECT MANAGER, THIS IS DELIVERABLE, ACHIEVABLE IN THE BUDGET PROPOSED. SIX, WOULD THE OUTPUT BE IMPLEMENTABLE BY ORGANIZATIONS OF VARYING SIZE AND SOPHISTICATION SO NOT BINDING caBIG, SOLELY FOR EXAMPLE, NCI CANCER CENTERS OR OTHER LARGE SCALE RESEARCH UNITS BUT ARE THE SOLUTIONS AND TOOLS MADE AVAILABLE. DO THEY HAVE A LOW ENERGY OF ACTIVATION TO BRING THEM UP AND USE THEM PRODUCTIVELY IN ORGANIZATIONS THAT ARE OF SMALL SIZE AS WELL AS LARGE SIZE. 70th IS THERE A DOCUMENTED PLAN FOR SUSTAINABILITY BASED ON APPLICATION AND USER BASE HAS THERE BEEN A STEAK HOLDER ASSESSMENT THAT IT WILL INDEED MET A CURRENTLY UNMET NEED. THAT'S KIND OF A RESTATEMENT OF THE FIRST CRITERIA AND IS IT LIKELY TO ADDRESS BROAD NEEDS AND THIS I THINK ADDRESSES ONE OF THE TERM REPORT AND THIS AFFECTS THE PROVINCE OF AN IN-GROUP OF FOLKS AND NOT BROADLY APPLICABLE TO THE ENTIRE FIELD OF CANCER RESEARCH AND THEN LASTLY, THE ACTIVITY RESOURCE OR APPLICATION HAVE ENOUGH MARKET VALUE TO GAIN ADOPTION WITHOUT INCENTIVES. AND THIS WAS THE COMMITTEES RECOGNITION THAT TO SOME EXTENT THE REPORTED USE OF caBIG TOOLS WAS OVERLAID WITH NCI FINANCIAL INCENTIVES TO ADOPT THOSE TOOLS AND TO THAT TO SOME EXTENT MASKED WHAT THEIR VALUE MIGHT BE BECAUSE IF YOU'RE A CANCER CENTER UP FOR RENEWAL, YOU WOULD INSTALL A FEW caBIG APPLICATIONS SO YOU COULD DO GRANTSMANSHIP TO SAY WE'VE DONE THAT AND WE WERE TEAM PLAYERS IN THE TEAM COMMUNITY caBIG BUT WHETHER THOSE WERE IN THE CRITICAL PATH OF THAT INSTITUTION, WHETHER THEY'RE CONTRIBUTING MEANINGFULLY TO TEAM SCIENCE, IF YOU WILL, WAS AN ISSUE AND IN THAT REGUARD, THE COMMITTEE COMPARED ITS EXPERIENCE TO THE CTSAs WHERE IN CTSA LAND FOR THOSE WHO ARE NOT FAMILIAR WITH THAT, THE LARGEST SUCCESSES OF THE CTSAs HAVE BEEN IN INFORMATICS, TOOLS AND INFRASTRUCTURE TO DO BIOMEDICAL CANCER RESEARCH AND THE TWO APPLICATIONS THAT HAVE GONE VIRAL IN CTSAs ARE RED CAPPED AND ITWO BTWO. ITWO BTWO CAME FROM ONE OF THE NCBCs, RED CAP'S A KIND OF VERY RAPID DEVELOPMENT TOOL TO DEVELOP A SECURE DATA CAPTURE SYSTEM. THEY WERE NEVER INCENTIVES PROVIDED TO ANY--TO MY KNOWLEDGE ANY CTSAs TO ADOPT EITHER OF THOSE APPLICATION SAYS. THEY DID BECAUSE OF THE NATIVE VALUE OF THOSE FOR DOING WHAT THEY NEEDED TO DO ANYWAY. SO MOVING CLOSER TO THAT MODEL WHERE VALUE IS EVIDENT BECAUSE OF THE INSTITUTIONS THAT WOULD ADOPT caBIG TOOLS IS EMBEDDED IN THIS 10th CRITERIA. AND THE OVERALL SUBCOMMITTEE PROCESS BY WHICH THOSE WILL BE APPLIED VISIT NCI WILL PROVIDE TO OUR SUBCOMMITTEE THREE THINGS. IT WAS-OF TWO THINGS TILL LAST NIGHT'S MEETING AND THEN WE ADDED ANOTHER BULLET, AN OVERALL TRACKING GRID OF THE PORTFOLIO, SO THAT WAS THE SURVEY THAT 30,000-FOOT LEVEL SERVICE PORTFOLIO COMBINED WITH STRUCTURED PROJECT SPECIFIC SUMMARY SHEETS SO THIS IS A DEEP DRIVE INTO EACH PROJECT TO PROVIDE INFORMATION FOR SUBSTANTIVE COMMITTEE REVIEW. AS A RESULT, THE MEETING WE ADDED TO THE BULLET THAT WE WOULD GET A SORT OF CONTEXT BRIEFINGS FROM NCI STAFF THAT IS RATHER THAN INDEPENDENTLY LOOKING AT ANY PARTICULAR PROJECT OR PROGRAM, WE WOULD HAVE THE PLACE THAT IT PROVIDES IN THE OVERALL STRATEGIC SPECTRUM OF caBIG PROVIDED VERBALLY IN AN INTERACTIVE DISCUSSION WITH NCI STAFF BEFORE GOING ABOUT THE BUSINESS OF WHAT WILL REALLY LOOK PRETTY MUCH LIKE THE STUDY SECTION. IN FACT, WE ADOPTED A PRETTY REASONABLE, I THINK APPROACH. THIS IS VERSION 1.0, OR PERHAPS VERSION 1.9 OF THIS AND WE'RE JUST ABOUT TO TO ENGAGE THE WORK OF ACTUALLY DOG PROJECT, PROJECT REVIEWS. AND REDECIDED TO ADOPT THE CURRENT MODE OF NCI, OF NIH STUDY SECTION SO FOR ANY OF YOU WHO HAVE NOT BEEN IN THE STUDY SECTIONS IN THE LAST FEW YEARS, THE WAY THAT THAT PROCESS IS NOW DONE IS IT'S REALLY ANCHORED WHAT'S CALLED THE IMPACT STORE AND THE TEXT OF THE COMPANIES AND IMPACT SCORE IS QUITE PROVOCATIVE. IT SAYS THAT IT'S THE ASSESSMENT OF THE LIKELIHOOD THAT THIS PROJECT WILL MAKE A SUSTAINED POWERFUL IMPACT ON THE FIELD. AND SO WHAT WE'RE INTENDING TO DO IN OUR WORKING GROUP EVALUATIONS IS HAVE INDEPENDENT OF SORT OF IF YOU WILL SCORING BY SUBCOMMITTEE MEMBERS OF THE IMPACT SCORES FOR EACH OF THE PROJECTS WE REVIEW AND THEN IMPORTANTLY WE ARE A SUBCOMMITTEE OF YOU. SO WE WILL REPORT THOSE OUT TO THE BSA FOR THE FINALA ADVISORY INPUT TO THE NCI. AND I THINK WITH PARTICULAR ATTENTION, AND THIS IS ALSO WHAT HAPPENS IN STUDY SECTIONS WHEN YOU IS A WIDE SPLAY. SO IF SOMEBODY GIVES SOMETHING A WON AND SOMEONE ELSE GIVE ITS A SEVEN, THEN WE NEED TO KNOW WHY. AND WE WILL REPORT AS A NARRATIVES OF IT IF WE HAVE SPLIT VOTES IF YOU WILL, OF THOSE VOTES IN PARTICULAR. SO LET ME STOP THERE AND THAT'S WHERE WE STAND. WE DON'T HAVE MORE THAN TO TELL YOU. WE THINK WE HAVE AN ORDERLY AND PRINCIPLED PROCESS IN PLACE AND THAT BY THE TIME WE REPORT TO YOU NEXT, WE WILL HAVE DONE THESE REVIEWS AND BE ABLE TO HAVE A COMMENT ON THE OVERALL SCOPE OF caBIG PROJECTS. >> THANK YOU, DAN FOR THE PRECEPTATION AND FOR YOU AND ALL THE MEMBERS OF THE SUBCOMMITTEE FOR WORK ON HELPING caBIG BE SUCCESSFUL. I WOULD ADD SITTING ON THE MEETING LAST NIGHT THAT THE SUBCOMMITTEE WAS ENCOURAGED TO WORK WITH caBIG LEADERSHIP TO REFINE A STRATEGIC VISION FOR THE OVERALL GOALS OF THE CEGG BIG PROGRAM, UNDERSTANDING--caBIG PROGRAM, UNDERSTANDING THE FIELD IS CHANGING QUICKLY AND IT WILL RESULT IN AN EVOLVING STRATEGIC PLAN IN ADDITION TO FOCUSING ON THE PARTICULAR PROJECTS THAT YOU COMMENTED ON. DRNCHL-- >> FRANK. >> JIM RAISED AN INTERESTING POINT EARLIER AND MANY INSTITUTIONS NOW ARE COLLECTING GENOMIC DATA TIED TO CLINICAL EVERGZ, EACH A LITTLE DIFFERENTLY IN MANY WAYS AND NOT AT THIS POINT, SHARED. IS THIS PART OF THE THOUGHT OF THE FUTURE OF caBIG AND HOW DO YOU SEE THAT NEED SORT OF BEING INCORPORATED WITH THE CURRENT ACTIVITIES OR FUTURE ACTIVITIES. >> YEAH, THANK YOU FOR RAISING THAT BECAUSE IT ALLOWS ME TO COMMENT THAT ACTUALLY WE AS A COMMITTEE SEE WE HAVE TWO CLASSES OF ACTIVITIES SO ONE IS THE KIND OF FOCUSING OR PRUNING OF THE CURRENT ACTIVITIES BUT THE CERTIFICATE GOING FORWARD, AND GOING FORWARD IN TERMS OF OUR PROCESS, WE VIEW THAT THAT'S FINDING--HAVING MECHANISMS TO IDENTIFY CUE OPPORTUNITIES FOR EMERGING CHALLENGES IN CANCER SCIENCE AND KEY AMONG THEM ARE THIS NOTION--UNLESS I WAS PRINCIPLE INVESTIGATOR OF THE EMERGE COORDINATION CENTER THAT'S DOING ELECTRONIC MEDICAL RECORDS AND OUR SLOGAN THERE IS GENOTYPES ARE EASY, PHENOTYPES ARE HARD AND THERE ARE A FEW STANDARDS FOR THE SYSTEMATIC REPRESENTATION OR INTEROPERABILITY IF YOU WILL OF OBSERVABLE PHENOTYPES AND SO, I THINK GOING FORWARD, THAT'S EXACTLY WHERE THIS COMMITTEE CAN BE SORT OF CONCEPT LEVEL BOTH GUIDANCE AND REVIEW FOR THE ISSUING OF EITHER RFAs, RFPs FOR THE KIND OF PROJECT THAT WE MAKE PROGRESS NANA CRITICAL AREA OF WHAT WE MIGHT CALL CLINICAL GENOMICS. >> WE HAVE A FEW MORE QUESTIONS. KRISTIN? >> HI, I'M WONDERING IN ASSESSING THE IMPACT OF THE VARIOUS PROJECTS HOW POTENTIAL UPTAKE WILL BE TAKING INTO CONSIDERATION BECAUSE I RUN A BIOREPOSITORY AT OUR CANCER CENTER AND WE WERE LOOKING AT caBIG YEARS AGO WHEN WE STARTED BUT IN THE MEAN TIME PEOPLE HAVE INVESTED A LOT IN THEIR OWN SYSTEM AND I THINK THIS APPLIES TO MANY TYPINGS OF DATA STORAGE APPROACHES. SO, HOW LIKELY IS IT THAT WHEN SOMETHING DOES COME OUT, USEABLE, TELL BE TAKEN UP AND HOW YOU'LL EVALUATE THAT. >> YEAH, SO PART OF THE PROJECT TEMPLATE IF YOU WILL, THE DEEP DIVE ON EACH IS A CATEGORY CALLEDs MEANINGFUL USE. WE SHAMELESSLY BORROWED THAT FROM THE OFFICE OF THE NATIONAL COORDINATOR AND WE EXPECT THAT WILL BE A DIFFERENT SET OF METRICS, BUT THEY HAVE TO BE OBSERVABLE QUANTITATIVE METRICS FOR THAT PARTICULAR APPLICATION OR RESOURCE SO THAT WE WOULD KNOW, IT REALLY WAS RETURNING THE INVESTMENT IN TERMS OF SCIENTIFIC PRODUCTIVITY. SO THAT'S--I THINK A SORT OF GENERAL RESPONSE TO YOUR QUESTION THAT WE'RE VERY SENSITIVE TO THAT ISSUE, BUT WE THINK THERE PROBABLY ISN'T A SIMPLE GENERIC STATEMENT OF HOW YOU WOULD DO THAT FOR EACH CLASS OF caBIG PROJECT BUT WE'RE WITH YOU. WE KNOW THAT NEEDS TO BE DONE BECAUSE THERE HAVE BEEN MEASURES OF USE THAT WE DON'T THINK ARE ACTUALLY MEAN BEINGFUL. THE NUMBER OF HITS ON A WEB SITE OR AFFLICTED DOWNLOAD, YOU KNOW A PIECE OF SOFTWARE SO IT'S A START BUT IT'S NOT A MEANINGFUL MEASURE OF USE. >> DAN, AS YOU DESCRIBED IT, IS THIS GOING TO BE A PREAWARD REVIEW OR A POST--I KNOW YOU'RE DRILLING DOWN ON THE PROJECTS THAT XYST EXIST TODAY BUT IN THE FUTURE YOUR IMPACT SCORE BECAUSE IT SEEMS LIKE, ARE YOU GOING TO--FUNCTION AS A STUDY SECTION AND JUST HOW THIS WILL COME ABOUT AND THEN POST AWARD, HOW OFTEN WILL THEY BE EVALUATED. HOW OFTEN WILL WE SEE AN IMPACT SCORE AND OBVIOUSLY IT'S GOING TO--VARY WITH THE PROJECT IN TERMS OF THIS, IT'S OVERALL IMPACT. >> YEAH, SO WE BELIEVE THAT, IN THESE TWO CLASSES THAT REVIEW, THE EXISTING PORTFOLIO IS WHERE WE WILL BE KIND OF DOING IMPACT SCORES FOR THE FUTURE, WE'RE MUCH MORE GOING TO BE LIKE THE BSA, THAT IS WE WILL BE DOING CONCEPT REVIEWS, WE WILL NOT I THINK BE DOING THIS, THE ACTUAL PROJECTS BECAUSE ONE OF THE RECOMMENDATIONS OF THE REPORT IS THAT THEY ROUTE THROUGH STANDARD PEER REVIEW MECHANISMS SO THERE WILL BE EXPERTS PEER REVIEWERS AND IT WON'T BE US, I DON'T THINK THE COMMITTEE HAS THE BAND WIDTH AND WE'RE TOO SMALL AND THAT WOULD BE, I THINK TOO MUCH MICROMANAGEMENT TO THE PROCESS TO BE DOING THAT. ARE THERE QUESTIONS? >> IF NOT, THANK YOU VERY MUCH AND WE LOOK FORWARD TO HEARING YOUR NEXT REPORT. SO WE WILL TAKE A SHORT COFFEE BREAK AND--20 MINUTES, BACK AT 10:45. [BREAK ] ]I„ >> O ANOTHER PART OF THE BSA MEETING--SO AN IMPORTANT PART OF THE BSA MEETING IS BRINGING TO THE ATTENTION MEMBERS WHO ARE LEADERS OF MANY CANCER RESEARCH INSTITUTES AROUND THE COUNTRY TO MAKE THEM AWARE OF RESOURCES THAT ARE IN PEST ENS THAT MAY--PEOPLE MAY NOT BE FULLY AWARE OF AND THIS IS ONE GOOD EXAMPLE OF THAT. SO WE„i ARE GOING TO HEAR ABOUT THE CHER NOBLE TISSUE BANK AND GIVE US A BRIEF SIN OPPOSITE SIS D. >> THIS IS A UNIQUE PROJECT WE HAVE AT NCI D.--I'M SORRY, THERE IS A PROBLEM HERE. >> OKAY, WE GOT IT. IT'S MY PLEASURE TO INTRODUCE ONE OF THE UNIQUE PROJECTS WE HAVE HERE AT NCI, THE CHERNOBYL TISSUE BANK THAT WAS ESTABLISHED AFTER THE AFTER MATH AND IN THE THEY--THEATICS OF THE CANCER. THIS WAS AN INTERNATIONAL COLLABRATIVE RESPONSE. NOW CANCER IN CHILDREN, I'M SORERY THERE IS A PROBLEM IN THE POWER POINT PRESENTATION HERE. IT'S NOT GOING FORWARD. OKAY, HERE WE GO. CANCER IN CHILDREN IS USUALLY VARIABLE BUT WITHIN FOUR TO FIVE YEARS OF THE INCIDENCE OF CHERNOBYL THERE WAS AN UNPRECEDENTED INCREASE IN PEDIATRIC CANCER, PARTICULARLY THE LOWER UKRAINE REGIONS OF RUSH WAAND THIS THYROID CANCER HAS AFFECTED MOSTLY THE PEDIATRIC POPULATION, 14 YEARS YOUNGER AND ALSO IN YOUNG ADULTS. IT HAS BEEN ESTIMATED THAT AROUND 5000 CASES OF THYROID CANCER HAS GENERATED FROM CONTAMINATION MOSTLY 131 CONTAMINATION. SO THE SCIENTIFIC COMMUNITY WAS MARBLEIZED AT THAT POINT AND THERE WAS A NEED FOR THE IMPORTANT TISSUE THE CHERNOBYL TISSUE BANK WAS A RESPONSE TO THIS IN ACQUIRING THE THYROID CANCER CASES, MOSTLY CONTAMINATED THE LOWER PART OF RUSSIA FOR A PATIENT WHO WERE UNDER 19 YEARS OF AGE AT THE TIME OF THE CHERNOBYL ACCIDENT CAN IT'S A PERSPECTIVE COLLECTION AND BECAUSE ARCHIVE STANDS AT 38, 61 CASES OF APPROXIMATELY 2800 HAS BEEN ALREADY CONFIRMED BY THE PATHOLOGY PANEL AS THYROID CANCER THE CHILD WE SEE IN CHERNOBYL WHICH IS THE PAP ILLEGALSARY TYPE. NOW ONCE WE SHUT OFF THIS TISSUE BANK TDOES NOT RELYOT HOSPITAL REPORT OF PATHOLOGY. IT HAS ITS OWN PATHOLOGY PANEL AS VERY UNIQUE PATHOLOGY PANEL THAT HAS ESTABLISHED A SYSTEMATIC APPROACH TO THE REVIEW OF THE SAMPLES AND THEY MEET ONCE A YEAR, THEY GO THROUGH ALL'c THE CASE AND IN THE CASES, IT'S NOT DOCUMENTED AS A THYROID CANCER IN THE ARCHIVE UNLESS IT'S REVIEWED BY THE PATHOLOGY CHANNEL. SO THERE ARE ADDITIONAL CASES THAT WILL BE REVIEWED AT THE NEXT MEETING. IN TERMS OF THE ORGANIZATIONAL STRUCTURE OF THE TISSUE BANK, IF IT'S COLLABORATIVELY SUPPORTED BY NCI, EUROPEAN COMMISSION AND THE FOUNDATION OF JEOPARDY„i AN. THE PROJECT IS MANAGED BY COORDINATING CENTER LOCATED AT THE IMPERIAL COLLEGE IN LONDON, THAT'S WHERE THE PRINCIPLE INVESTIGATORS, DR. THOMAS IS, AND OVERSEAS REPOSITORIES IN RUSSIA AND UKRAINE. NOW, ONE WAS A PARTNER IN THE INITIATION OF THE PROJECT BUT THE GUTS OF A FEW YEARS AGO FOR POLITICAL REASONS ALTHOUGH NEGOTIATION WITH FELLOWS ARE ONGOING. IN TERMS OF THE GOVERNANCE OF THE PROJECT, THE GOVERNANCE IS COMPLEX AND THE PROJECT IS OVER SEEN BY STEERING COMMITTEE, THIS IS COMPOSED OF REPRESENTATIVE FROM THE SPONSORING ORGANIZATION AS WELL AS THE DIRECTORS OF THE INSTITUTE IN THE CHERNOBYL COUNTRIES, THE STEERING COMMITTEE IS SUPPORTED ORAZ VISED BY A NUMBER OF SCIENTIFIC BOARDS INCLUDING THE EXTERNAL REVIEW PANEL, THE PATHOLOGY PANEL WHICH I JUST TALK ABOUT AND SO FORTH. THESE SCIENTIFIC ROLES ARE STAFFED BY EXTRAMURAL INVESTIGATORS AND THEY GET NOMINATED BY THE SPONSOR OR THE ORGANIZATION AS WELL AS PARTICIPATING COUNTRIES. AND NCI HAS A NUMBER OF EXTRAMURAL INVESTIGATORS ON THESE PANELS. IN TERMS TO ACCESS TO THE TISSUE MATERIAL USUALLY DONE BY APPLICATION THAT CAN BE APPLIED THROUGH THEIR WEB SITE AND GET REVIEWED BY THE TISSUE BANK REVIEW PANEL, EXTERNAL REVIEW PANEL, IT'S DONE BASICALLYOT SCIENTIFIC MERIT BECAUSE THESE ARE RARE TISSUE, IT'S THE EVERYARCHING GOAL HERE AND CONCURRENCE BY THE SCIENTIFIC ADVISER BOARD IS ALL YOU NEED IS THE APPLICATION IN THE MIDDLE ASK THERE'S A QUESTION ABOUT THE SCIENTIFIC APPROACH USED IN THE APPLICATION. ONE OTHER FEATURE OF THIS TISSUE BANK IS THAT IT DOES NOT SUPPLY THYROID TISSUE PIECES TO INVESTIGATOR, IT RATHER SUPPLIES TISSUE SECTIONS AND ANALYZED LIKE RNA AND DNA AND SO FORTH. AND BASICALLY BECAUSE THESE ARE RARE TUMORS. SOPHISTICATED PRESERVE THE TUMOR BY THE SCIENTIFIC COMMUNITY AND IT ALSO HAS BEEN AN, PROACH OF PROMOTING COLLABORATION AND SO THE INVESTIGATOR CAN ADDRESS VARIOUS QUESTIONS ON THE SAME PIECE OF TUMOR. I APOLOGIZE THERE'S AN ISSUE WITH POWER POINT. SO WE WERE JUST TALKING ABOUT THE SPECIMEN THAT HAD BEEN RELEASED, THIS SHOWS THE ALOE QUATS THAT HAD BEEN RELEASED TO VARIOUS PROJECT, AND THE HAS BEEN RELEASED IN THE LAST THREE YEARS AND IT SHOWS THAT THERE HAS BEEN AN INCREASE IN DEMAND FOR THIS MATERIAL, RNA, DNA FROM BLOOD AS WELL AS PARAFFIN EMBEDDED SECTION, BUT SWREE TO KEEP IN THE PERSPECTIVE, THE CANCER COMMUNITY IS A SMALL COMMUNITY, THIS IS A REQUIRE DISEASE. SO WE DON'T HAVE THE LARGE GROUP OF INVESTIGATORS THAT WE SEE PERHAPS IN THIS OTHER TYPES OF CANCERS. NOW IF I WANT TO UNDERLIE WHAT THE SIGNIFICANCE OF THESE PROJECTS AND WHY WE THINK AT THE NCI, IT'S SO UNIQUE, ONE CAN TALK ABOUT THE LARGEST COLLECTION OF THYROID TUMORS, THIS IS NOT MATCHED BY ANY OTHER RESOURCE. ALSO THE COLLABORATION BETWEEN SCIENTISTS THAT THIS PROJECT IS PROMOTING, THAT IT'S--YOU KNOW AT THIS POINT, THEY ARE TRYING TO BUILD A DATA WAREHOUSE SO INVESTIGATORS IN THE SCIENTIFIC COMMUNITY CAN ACCESS THE ROLE OF RESEARCH DATA THAT ARE GENERATE FRIDAY THE PROJECT. THE AMOUNT OF GLOBAL COLLABORATION IS VERY UNIQUE. IT'S ACTUALLY--IT CAN SERVE AS A MODEL FOR OTHER PROJECTS OR OTHER QUESTIONS THAT WE WANT TO EXPLORE INTERNATIONALALLY. THE HISTORY OF THE PROJECT, THAT CAN SERVE, YOU KNOW, OTHER GLOBAL DISASTER LIKE THE RECENT PUKE PUKE SEEMA ACCIDENT--BUT ONE OTHER POINT I WOULD LIKE TO BRING TO YOUR ATTENTION IS THAT THERE'S AN UNPRECEDENTED INCREASE IN SPORADIC THYROID CANCER IN THIS COUNTRY, NOT NOT JUST IN THIS COUNTRY BUT AROUND THE WORLD. AND THE TYPE OF THYROID CANCER IS THE SAME TYPE THAT HAS BEEN SEEN IN CHERNOBYL WHICH IS PAP ILLEGALSARY SYEROUS CANCER AND THE STUDIES FROM CHERNOBYL DOES NOT SHOW ANY RADIATION SIGNATURE, SO THAT THE DIFFERENCE IS IN THE BIOLOGY, THE BIOLOGY BETWEEN THE ADULT CASES OF CANCER AND THE CHILDREN CASES MUCH CYEROUS CANCER AND DEFINITELY WE THINK THAT THE STUDY OR CHERNOBYL CAN BENEFIT THE SPORADIC RESEARCH IN TERMS OF EXCHANGING INFORMATION BECAUSE THERE IS NO RADIATION SIGNATURE, AND THE NCI HAS TAKEN STEPS TO BRING THESE TWO CAMPS TOGETHER TO TALK AND EXCHANGE IDEAS. NOW EARLIER IN MY PRESENTATION, I INDICATED THAT THE PROJECT IS COLLABORATIVELY FUNDED BY THE NCI. BY THE EUROPEAN COMMISSION IS BY THE FOUNDATION. HOWEVER, ONE POINT I NOT TO MAKE HERE, THIS IS NOT DUPE PLICAATIVE, NOT THAT EVERY AGENCY IS GIVING MONEY THIS, IS VERY MUCH MISSION BASED. THE NCI FOCUS IS ON CANCER RESEARCH WHILE THE OTHER AGENCY FOCUSES IS ON RADIATION SCIENCE. SO IT'S A VERY COLLABRATIVE AND BENEFICIAL INTERACTION. AND WITH THIS RAISES ANY QUESTION. I'M SORRY ABOUT THE POWER POINT THERE,'S SOME ISSUE. >> THANK YOU FOR THE PRESENTATION COULD I START WITH ONE SPECIFIC QUESTION, WHAT'S THE STATE OF INFORMED CONSENT FOR GENETIC ANALYSIS. >> THE PROJECT HAS ITS OWN GENOME, HAVE YOU THREE DIFFERENT COUNTRIES PARTICIPATE NOTHING THE PROJECT, AT LEAST INITIALLY AND THE COORDINATING CENTER, ALSO HAVE THE INFORMED CONSENT. THE CONSENT IS MORE GENERATING METHODS APPLIED OUTSIDE AND INDICATE THAT ANALYSIS CAN BE DONE IN TERMS OF, YOU KNOW VARIOUS SCIENTIFIC QUESTIONS, SO IT'S VERY BROAD IN THAT PERSPECTIVE. THAT SOUNDS SPECIFIC LIKE THAT WOULD NOT SET THE BAR FOR PC GA LIKE COMPREHENSIVE-- >> WELL, ACTUALLY, THE COLLECTION, IN TERMS OF PC GA, I THINK THEY NEED TO GO BACK AND ADD, YOU KNOW, POWER ADAPTED INFORMED CONSENT THAT THE EXAMPLE CAN BE USED SO THE COMMITTEE REQUIREMENTS, YOU KNOW AT THE FOREIGN SIDE IS A LITTLE BIT DIFFERENT AND PERHAPS MORE RESTERRATE THAN WHAT WE HAVE HERE IN THE UNITED STATES. >> I WAS WONDERING ABOUT THE PROTOCOL FOLLOWED BY SPECIMENS. DOES IT FOLLOW THE NCI STANDARD? >> YES, ACTUALLY THE PROTOCOL IS RIGHTLY DEVELOPED BY THE COORDINATING CENTERS, AT NCI AND THEY MAKE SURE THAT THESE SITES COLLECT EXACTLY WHAT IT IS CALLED. THEY DON'T COLLECT ON THEIR OWN, THEY MAKE SURE THAT THIS IS FOLLOWED, YES. >> STIMJOE AND THEN HERB? >> WHAT FOLLOW UP DO YOU HAVE? DO HAVE YOU CLINICAL INFORMATION? SO THERE'S NO RADIATION SIGNATURE IN THE RADIATION CANCERS IN ANY AND KNEW THIS FROM THE JAPANESE SO THAT'S PROBABLY A PATHWAY I WOULDN'T PURSUE. BUT OTHER INFORMATION. SO WE KNOW AGE IS IMPORTANT, THE YOUNGER, THE HIGHER THE RISK. THE GENRATIVE BACK GRABBED IS IMPORTANT AND THEN DOSE ASK AND WE STRUGGLED WITH BELOW TWO SIEVERTS IN TERMS OF HOW THAT CURVE GOES. SO DEYOU HAVE THAT INFORMATION? IT SEEMS LIKE THOSE WOULD BE THE PERTINENT QUESTIONS THAT I MIGHT ASK OR WOULD HOPEFULLY GET ANSWERED IN THE FUTURE. >> YES, ACTUALLY, THERE IS A--DEFORMITY WORKING GROUP THAT HAS BEEN ESTABLISHED MANY YEARS AGO TO LINK THE DOSE OF EXPOSURE TO THE THYROID SPECIMEN THAT ARE COLLECTED AND THERE ARE ISSUES THAT WE CAN DISCUSS ABOUT PUTTING DEFORM ATRY, BUT LOOKING AT THE ACCIDENT, DURING THE AGE, AND THE THAT DOESN'T SEEM TO BE A RADIATION SIGNATURE, IT'S THE BIOLOGY, THE BIOLOGY AS I SAID OF THE YOUNG VERSES THE ALL THE CASES OF THYROID CANCER AND THIS IS EVEN ESTABLISHED IN THE SPORADIC THYROID CANCER FIELD IS THAT HAVE YOU CERTAIN BIOLOGY AND IT'S VERY, PARALLEL TO EACH OTHER. >> YEAH, WHEN YOU SAY THAT THERE'S NO RADIATION SIGNATURE, DO YOU MEAN THERE'S NO CORRELATION WITH EXPOSEURE? >> IF WE GO BACK TO THE ACCIDENT, ALL THESE THYROID CANCER CASE VS GENERATED FROM IL131 AND THE OTHER THERE IS NO OTHER DISEASE SO FAR OF THE LATE RADIATION EFFECT ONLY CYEROUS CANCER AND THE REASON WE KNOW THAT IS BECAUSE KIDS WERE MALNUTRITIONS AT THAT TIME, THEY TOOK MILK, THE COW MILK WAS CONTAMINATED AND IT WAS SATURATE WIDE IL131 AND THEY GET OUT THE THYROID CANCER. SO INITIALLY, PRIOR TO THIS TISSUE BANK THERE WAS TOO MUCH RESEARCH GOING ON AND THERE WERE PUBLISHED PAPERS SAYING, YES, THERE IS A RISK, PTC ARRANGEMENT WHICH IS A SIGNATURE, THAT TURN TED OUT TURNED OUT TO THE TO BE THE CASE, SO THE PTC ARANKMENT IS A CASE THAT YOU CAN FIND IN THE PEDIATRIC POPULATION BUT AS THEY AGE, THEY GO TO THE BRAS MUTATION, THE BRASE MODEL WHICH IS CONTAM NAT ONE AND IT'S IN THE SPORADIC THYROID CANCER, ONE OTHER POINT IS THAT SO THERE'S REALLY NO RADIATION SIGNATURE. SO FAR, FROM ALL THE STUDIES, NOBODY HAD SEEN SPECIFIC SIGNATURE, THE STUDIES THAT HAVE PUBLISHED IT, WE HAVE TO LOOK AT IT, WITH, YOU KNOW CAREFUL ASSESSMENT BECAUSE OF THE VARIOUS CONTROL GROUPS THAT ARE USED. >> OKAY, LET ME ASK IN A SLIGHTLY DIFFERENT WAY, WHAT FRACTION OF THE TUMORS THAT YOU'RE COLLECTING ARE ESTIMATED TO BE RADIATIONIVITY. >> THESE ARE ALL FROM THE PATIENT WHO LIVED IN THESE CONTAMINATED. SO THESE ARE ALL CHERNOBYL. >> YES, I UNDERSTAND THEY ARE FROM THE AREA, WHAT FRACTION OF THESE THINGS WOULD HAVE OCCURRED HAD WE NOT HAD THE INCIDENT. >> I CAN SAY WITH CONFIDENCE ALMOST ALL THE WONDERS ARE DOCUMENTED IS CHERNOBYL AND THE REASON FOR THAT IS BECAUSE THE PATHOLOGY PANEL HAD PUBLISHED SORT OF A MANUEL ON THE WAY THESE TUMORS WILL LOOK AND HOW WE CHANGE WITH AGE AS THE PATIENT GETS OLDER. SO, THESE CASES WOULD NOT HAVE BEEN DOCK UTRED AS CHERNOBYL UNLESS THEY HAVE LINKED IT WITH THE DOSE OF RADIATION EXPOSURE, THE AGE OF KIDS. USUALLY KID--CHILDREN GET IN THAT AREA, IT'S ESTIMATED THE INCIDENCE OF THYROID CANCER IT'S FOUR%. AFTER CHERNOBYL IN THIS AGE GROUP, IT JUMPS TO 89%. >> SO MAYBE YOU ANSWERED THIS BUT I WANT TO GO BECOME TO IT. FOLLOWING HIROSHIMA AND NAGGA SACKY, THERE WAS AN INCREASED INCIDENT, IT WAS 10 TO ON 14 YEARS LATER OF MILEOG NOWS LEUKEMIA. AND THE ATOM BOMB COMMISSION AND THEN THE RCA OR WHATEVER IT WAS RADIATION RESEARCH COUNCIL, WHERE THOSE PATIENTS SAVED THE BONE MARROW AS VIABLE CELL SUSPENSIONS AND FROZE THEM DOWN AND THAT ENABLES PEOPLE LIKE US TO GO BACK AND ACTUALLY DETERMINE THE SUBSET OF CELLS THAT HAD THE LEUKEMIA INDUCING POPULATION. NOW IS THERE NO INCREASE IN THE LEUKEMIA? >> I'M SHOCKED THERE IS NONE BECAUSE PEOPLE WHO GOT THE DOSE SUFFICIENT TO HEMEAT O POEETIC FAILURE. SO YOU WOULD EXPECT MY O DISPLASSIA OR INCREASED INCIDENCE AND IF IT DID HAPPEN IS THERE A VIABLE BONE MARROW CELL SUSPENSION FROM THOSE PATIENTS? >> RIGHT. SO ON THE 25th ANNIVERSARY, THERE WERE A SERIES OF PAPERS PUBLISHED AND STUDIES DONE ABOUT CHERNOBYL AND THE LATE HEALTH EFFECT. SO FAR THE ONLY ESTABLISHED SCIENTIFICALLY CONFIRMED LATE HEALTH EFFECT IS THYROID CANCER. LEUKEMIA HAPPENED IN THE LIQUIDATED POPULATION, THE ONE WHO TRIED TO CLEAN THE PLANT AND THAT IS ALREADY DOCUMENTED BUT ASIDE FROM THIS POPULATION, IS AN ESTABLISHED LINKAGE BUT NCI ACTUALLY HAS TWO EPIDEMIOLOGY COHORTS, ONE IS LUNG CANCER KEEP CAAND ONE ON THYROID CANCER THAT IS MANAGED BY THE DIVISION OF CANCER EPIDEMIOLOGY AND GENETIC BUT IN TERMS SO THE TISSUE BANK WE'RE GOING TO ESTABLISH IS A CALL TO THIS INCREASE IN THYROID CANCER BUT SO FAR, YOU KNOW THERE ARE REPORTS OF CARDIOVASCULAR DISEASES AND THEY ARE SURVEYS FASSING NOW BUT I WILL LOOK AT WITH CAREFUL ASSESSMENT. THANK YOU VERY MUCH FOR THE PRESENTATION WE SHOULD MOVE ON TO THE NEXT SERIES OF ITEMS OF BUSINESS WHICH ARE TO CONSIDER FOUR RFAs, THREE REISSUES AND ONE NEW RFA CONCEPT. THE FIRST ONE IS A DATA RESEARCH FOR BLOOD AND MARROW TRANSPLANTS. THE SUBCOMMITTEE FOR THIS WAS CHAIRED BY KURT SIEVEIN AND KEY DANG WHO IS NOT HERE AND DAN GURSIN. WE BELIEVE THE COMMITTEE DID NOT REQUEST A PRESENTATION SO COULD YOU GIVE US YOUR THOUGHTS. >> YEAH, WE THOUGHT THIS WAS A TERRIFIC CASE FOR REISSUANCE AND THAT WAS THE CONSENSUS OF THE COMMITTEE, THIS IS ESSENTIALLY THE RESOURCE THAT FUNDS OUTCOMES RESEARCH ON BONE MARROW TRANSPLANT PATIENTS PATIENTS AND DOES THIS INTERNATIONALALLY, NORTH AMERICA AND IN COLLABORATION WITH THE EUROPEAN AND OTHER INTERNATIONAL ORGANIZATIONS. IT'S REALLY QUITE VISIONARY IN SEEING THIS FORM OF OUTCOMES RESEARCH AND HEALTH OUTCOMES RESEARCH DECADES AGO WAY BEFORE SOME OF US REESHTED--APPRECIATED THE NEED FOR THIS BUT EVERYTHING IN BONE MARROW TRANSPLANT NOW IS SUBJECTED TO THIS OUTCOMES ANALYSIS. WE DON'T THINK THERE'S A BETTER WAY TO DO IT. WE THINK THAT THE LEADERSHIP WAS OUTSTANDING AND THROUGH THIS COLD, THAT'S WHAT I REMEMBER. >> STAN? >> I WOULD ONLY COMMENT THAT THE NUMBER OF HIGH IMPACT PUBLICATIONS THAT HAVE CHANGED THE PRACTICE IN THIS FIELD OF THE USE OF BONE MARROW TRANSPLANT FOR ADVANCED HEMOLOGIC MALIGNANCYS AND OTHER RELATED DISORDERS IS QUITE IMPRESS AND I HAVE PIRHAPPENS EVEN MORE IMPRESSIVE THAT ARE ACCOMPLISHED CLINICAL TRIALS AND MANAGED TO COLLECT WORLD WIDE DATA WHICH HAS REMARKABLE IMPACT. DSM. >> SOUNDS LIKE THERE IS ENTHUSIASM. OTHER COMMENTS FROM OTHER MEMBERS OF THE BOARD IN. --BOARD? OKAY. DO I HEAR A MOTION TO CONCUR WITH REISSUANCE? >> SO MOVED. >> SECOND? >> HERE. >> ANY FURTHER DISCUSSION? >> ALL IN FAVOR OF REISSUANCE? ANY OPPOSED? ABNORMALITIES TENSIONINGS TENSIONINGS--ABNORMALITIES TENSIONS? OKAY, UNANIMOUSLY IN FAVOR. THANK YOU VERY MUCH THE iMAT PROGRAM, AND JOSH LA VALID AND RELIABLE ON THE SUBCOMMITTEE AND THE SUBCOMMITTEE REQUESTED A PRESENTATION. SO WHY DON'T WE START WITH THAT. >> PLEASE? >> YEAH, SO THE--I THINK THE COMMITTEE WAS OVERALL HIGHLY ENTHUSIASTIC ABOUT THIS PARTICULAR PROGRAM. THE--IT'S SORT OF THE ONLY GAME IN TOWN FOR TECHNOLOGY DEVELOPMENT AND I THINK THAT THE REVIEW COMMITTEE THOUGHT THAT THE IMPACT OF THE PROGRAM HAD BEEN PARTICULARLY HIGH. AND THE REASON FOR ASKING FOR A PRESENTATION ON THIS WAS BECAUSE WE THOUGHT IT WAS SO HIGH THAT WE WANTED TO BRING IT TO THE ATTENTION OF THE BSA AND ASK THE QUESTION, ARE WE INVESTING ENOUGH MONEY IN THIS PARTICULAR MECHANISM. SO THAT'S--SO WE'VE ASKED THEM TO TRY TO BRING EVERYBODY UP TO SPEED ON WHAT'S BEEN ACCOMPLISHED. >> THANK YOU. >> MY NAME'S TONY AND IT'S MY PLEASURE TO PRESENT THIS REQUEST TO THE BORED--BOARD OF SCIENTIFIC ADVISERS TO REISSUE FUNDING ANNOUNCEMENTS FOR THE INNOVATIVE AND MOLECULAR ANALYSIS TECHNOLOGIES PROGRAM. WE ARE REQUESTING ISSUE OF RFAs FOR MULTIPLE RECEIPT DATES IN 2012. BEFORE GOING INTO THE PROGRAM ITSELF, I WANT TO SUGGEST THAT THE FOUNDATION FOR REQUEST LIES IN THREE POINTS. THE FIRST BEING THAT THE NCI'S INVEST ENEMY TECHNOLOGY DEVELOPMENT THROUGH INVESTIGATOR INITIATED„i RESEARCH HAPPENED PREDOMINANTLY THROUGH THE IMAP PROGRAM. SECOND, AS IS INDICATE INDEED THE MULTIPLE EVALUATIONS ON THIS PROGRAM, THAT HAS SUCCEED INDEED DELIVERING ON ALL FOUR OF ITS PROGRAM GOALS AND THAT THE RFA MECHANISM ITSELF IS A CRITICAL COMPONENT OF THAT SUCCESS BECAUSE OF HOW IMPORTANT REVIEW AND REFERRAL FROM THE COMPLICATED AND WIDELY VALID AND VCRYING APPLICATIONS ARE AND MOST IMPORTANT IS THAT THE IMAP PROGRAM CONTINUES TO RECEIVE A LARGE NUMBER OF APPLICATIONS PRIMATESICATIONS OFTEN RESULT NOTHING OUR ABILITY TO FUND PROMISING PROJECTS THAT WE WOULD LIKE TO INCLUDE AND WE OFTEN ASK, IT'S NOT RARE TO ASK APPLICANTS TO THE RATER RECEIPT DATE TO BE ABLE TO FUND IT AT THE NEXT ROUND. THE DOCUMENTATION THAT'S BEEN SUBCOMMITTED PROVIDES INFORMATION AND GOALS SO I WANT TO CONSIDER THESE HALLMARKS OF THE IMAP PROGRAM, THE FIRST IS THAT IT'S 100% INVESTIGATOR INITIATED WE DON'T TELL WHAT WE'RE INTERESTED IN DEVELOPING WE ASK THEM TO SUBMIT TO US THEIR INNOVATIVE IDEAS, AND SECOND THAT THE HIGH RISK HIGH REWARD NATURE OF THE PROGRAM IS THE IMAP PROGRAM IS A PROGRAM INTEND ON PUSHING THE TECHNOLOGY AND MEDICINE AND RESEARCH FOR CANCER. WE USE THE R21 MECHANISM HEAVILY AND AS SUCH, TECHNICAL FEASIBLE IS IMPORTANT IN REVIEW OF APPLICATIONS IMAP HAS A REP YOUITATION FOR TAKING SIGNIFICANT RISK BECAUSE OUR FOCUS IS REALLY ON THE POTENTIAL--POTENTIAL FOR PROJECTS TO BE TRANSFORMATIVE TO THE FIELD AND FINALLY, THE PROGRAM IS TRANSDIVISIONAL ACROSS THE EXTRAMURAL DIVISIONS OF THE NCI AND CENTRALLY ADMINISTERED OUT OF THE OFFICE OF THE DIRECTOR, THAT THROUGH THIS COOPERATIVE MANAGEMENT FUNCTION WE BRING TOGETHER EXPERTISE AND PERSPECTIVES FROM ACROSS NCI IN HOUR TO CONSIDER THE POTENTIAL NOVELTY AND POTENTIAL IMPACT OF THESE APPLICATIONS. THIS IS THE STRUCTURE OF TECHNOLOGY DEVELOPMENT WITHIN IMAP. THEY'RE EXPLORATORY DEVELOPMENT, AND WE CERTAIN ENCOURAGE THOSE THROUGH THE R21 PHASE THAT ARE MIGHTING MILESTONE SYSTEM HAVE PROMISING TECHNOLOGIES FOR THE FIELD TO FIELD SUPPORT FOR CONTINUED DEVELOPMENT OF THEIR TECHNOLOGIES. WHEN DR. CAROLYN PRESENTED THIS PROGRAM TO THE BOARD OF SCIENTIFIC ADVISERS IN 2007 FOR REAUTHORIZATION, SHE BROUGHT UP MANY OF THESE TECHNOLOGIES AND THIS IS OF-AS DR. GRAY SUGGESTED WE ARE FOCUSING OUR PRESENTATION ON SUCCESS STORIES OUT OF THE PROGRAM TO GIVE YOU A BREDTH OF THE TECHNOLOGY THAT IMAP SUPPORTED AND CERTAINLY THESE, I BRING UP AGAIN FOR THE BENEFIT OF THOSE BOARD MEMBERS WHO WEREN'T HERE TO SEE SOME OF THE OLDER SUCCESS STORIES THAT CAME OUT OF IMAP, MANY OF WHICH ARE HOUSEHOLD NAMES AND WE'RE NOT CERTAINLY CAMING THAT IMAP DESERVES SOLE CREDIT FOR THE SUPPORT OF THESE PROGRAMS BUT IT IS TRUE THAT IMAP PROVIDED SUPPORT AT VERY EARLY STAGES OF STAGE IN EACH AND EVERY ONE OF THESE PLATFORMS. NOW DELVE INTOG THE MORE RECENT TECHNOLOGIES THAT HAVE BEEN SUPPORTED BY IMAP. DR. JIM LAND ORS AT THE UNIVERSITY OF VIRGINIA DEVELOP TED MICROGENETICS ANALYSIS PLATFORM, AND IT ACCOMMODATED TISSUE OR BLAD SAMPLES THAT WOULD PURIFY EXTRACT AND AMPLIFY DNA PREPARING FOR SEQUENCING AND 2008 INNOVATION OF THE YEAR AWARD FOR LABORATORY AUTOMATION AND LICENSED BY LOCH HE'D MARD AND I KNOW SIGNIFY GAND. RAIN DANCE TECHNOLOGIES DEVELOP THEIR INITIAL PLATFORM WITH SUPPORT AND IN CASE YOU'RE NOT FAMILIAR WITH THIS ONE. THIS PLATFORM PRODUCES NANO LITER SCALE, OIL DROPMENTS THAT SERVE AS FUNCTIONAL EQUIVALENTS OF TEST TUBES THAT ARE ACCOMMODATED EITHER SINGLE CELLS OR SINGLE REACTIONS OR EVEN SINGLE MOLECULES AND THE REAL TRANSFORMATIVE NATURE OF THIS PLATFORM WAS IT WAS REDUCED THE AMOUNT OF PROCESS INDUCED BY THESE AND STILL ACCOMMODATED MASSIVELY PARALEAL PROCESSING. YIELDING HIGH SPEED WORK FLOWS AND IT WAS THE RUNNER UP FOR THE 2009 INNOVATION OF THE YEAR AWARD BY THE SAME ASSOCIATION. DR. MIKE MCGORGAS, DEVELOPED THE LOWER TEMPERATURE PC R OR COLD PC R AT DANA-FARBER, AND IT PREFERENTIALLY MUTATED DNA AND LICENSED BY TRANSGENOMIC AND USE INDEED THE SURVEY LINER OF SEQUENCING PRODUCTS. >> A--IT DOES THIS BY ATTACHING TRACKING BEADS TO TRANSCRIPTIONALLY ACTIVE MRNA THROUGH THE TRANSCRIPTIONAL CHAPERONS AND IT HAS BEEN PICKED UP BY OCEAN RISK O SENTENCES--BIOSENTENCE SCIENCENESS AND IT'S IN A LATER STAGE NOW. THIS IS A A CLEVER NANO TECHNOLOGY THAT ALLOWS FORUNE DIRECTIONAL CAPTURE OF LOW ABUNDANCE PROTEINS AND COMPLEX MIXTURES LIKE LIAISON SADES AND IT'S A NANO--IT'S A HYDRO JELL PARTICLE THAT ALLOWS FOR THE PROTEINS IN THESE COMPLEX MIXTURES BUT ALSO PROVIDES PROTECTION OF THESE PROTEINS ONCE CAPTURED FROM PROTEASE ACTIVITY BEFORE EXTRACTION AND ANALYSIS. AND IT'S NOW COMMERCIALLY AVAILABLE THROUGH A PARTNERSHIP BETWEEN SENENSS AND DYNAMICS. THOSE LAST WERE ONES THAT WERE SELECTED FOR THE AMOUNT OF EXCITEMENT AND OF COURSE THE SUCCESSFUL IN PRODUCING THEIR TECHNOLOGIES, WHAT I'D LIKE TO GO INTO A COUPLE OF EXAMPLES WHERE WE HAVE TECHNOLOGIES THAT HAVE BEEN SUCCESSFULLY DEVELOPED AND WE SEE EVIDENCE OF BEING TAKEN UP BY THE RESEARCH COMMUNITY WITHOUT THAT COMMERCIAL ACTIVITY AND THE FIRST IS BILL HAUN AT DANA FASC BERNEA DEET AND IT PRODUCED A HE PROMOZZED TO THE IMAP PROGRAM TO DEVELOP A PLATFORM BY LEVERAGING, EMERGING TECHNOLOGIES OF THE TIME THAT WOULD ALLOW FOR A A SYSTEMATIC GENOME WIDE ASSESSMENT OF A LOSS OF FUNCTION OF GAIN OF FUNCTION AND PRONE TEEN-PROTEIN WORKED ANALYSIS. HE WAS SUCCESSFUL IN DEVELOP TAG SCREENING PLATFORM AND IT'S LED TO A NUMBER OF VERY WELL SITED PUBLICATIONS FOR HIM AND MANY COLLABORATORS AT THIS POINT BUT HE ALSO PROVIDED A NUMBER OF VERY IMPORTANT TOOLS TO THE CANCER RESEARCH COMMUNITY. JOSH ROUGH ATOM BIN O VITIS ANOTHER EXAMPLE AND HE PRODUCED PROBES THAT ALLOWED FOR THE QUANTITATION BY MASS SPECTROMETRY OF THE CONCENTRATION OF STRUCTURALLY DEFINED INTRACELLULAR METABOLITES HE WAS DEVELOPING THIS PLATFORM AND THE CITATION ACTIVITY AROUND HIS EMERGING PUBLICATIONS RIGHT NOW INDICATE TO US THAT HIS TECHNOLOGY AND HIS PLATFORMS AND METHODOLOGY WILL ALSO BE WELL ADOPTED BY THE COMMUNITY. THIS IS A SNAPSHOT OF THE CURRENT IMAP PORTFOLIO NOW. THERE ARE A HUNDRED PROGECS BROKEN DOWN AND THERE ARE 75% AND THE REMAINING QUARTER IS R33S. AND BUDGET TERMS THAT MAKES DOWN TO ABOUT A 60/40 SPLIT BETWEEN THE R21S AND R33S. PROBABLILY THE SINGLE LARGEST BROAD DIVERSITY OF TECHNOLOGY FOR WHICH THEY'RE DEVELOPED AND PROBABLILY THE LARGEST IS HIGH THROUGH PUT PLATFORMS WHICH IS CONTENT SCREENING CAPABILITY AND„i I BROKEN THEM INTO THREE, THE BOTTOM THREE PIE SLICESOT PIE CHART INTO WHETHER THE TARGETS ARE PROTEINSOR EPIGENETIC TARGETS. I DRAW ATTENTION TO THE LARGE GREEN PIE SLICE WHICH IS NOVEL BIOSENSORS AND CERTAINLY THERE'S A GREAT DEAL OF DIVERSITY WITHIN THIS PARTICULAR CATEGORY. MANY THAT YOU MIGHT EXPECT LIKE NOVARTISET PLATFORMS FOR CAPTURING, CIRCULATING TUMOR CELLS, MULTIPLEX ASSAYS, THAT SEEK TO GAIN ORDERS OF MAGNITUDE, OVER EALIZA--EALIZA NOVEL PLATFORM CHIPSOT PLATFORMS BUT THERE ARE UNICE PLATFORMS DEVELOPED, ONE TO STUDY DNA REPAIR INSIGHTUE. WE HAVE A STRUCTURAL ANALYSIS, TOOL, ON A NANO SCALE CALORIMETER AND OTHER VERY INTERESTING PROJECT. AND SO, SPECIFICALLY WHAT WE'RE TESTING FROM THIS BOARD IS PERMISSION TO REISSUE THESE FOUR RFAs FOR RECEIPT DATES IN 2012 THAT WOULD GIVE GRANTEE SUPPORT FOR UP TO THREE YEARS FOR BOTH THE R21S AND THE R33S. THE FIRST TWO ARE THE R21 AND R33 SUPPORT FOR TECHNOLOGY DEVELOPMENT THAT THERE'S CANCER RESEARCH AND THE BOTTOM TWO ARE TECHNOLOGY DEVELOPMENT AND SUPPORT OF CANCER BIOSPECIMEN SCIENCE. IN THE RIGHT COLUMN WE SHOW THE REQUESTED SET ASIDES FOR EACH OF THE FOUR RFAASKS THE ESTIMATED NUMBER OF AWARD WE ANTICIPATE BEING ABLE TO GIVE. I WANTED TO PROVIDE NOTES BASED ON THE FEEDBACK WE PROVIDED FROM DR. GRAY FROM THE SUBCOMMITTEES DELIBERATIONS AND FIRST IS THAT THEY FELT THE IMAP PROGRAM WAS SUPPORTING THE DEVELOPMENT OF TECHNOLOGIES THAT CONTRIBUTED TO PRESSING THE BIOLOGY TO THE FOREFRONT OF SCIENCE AND THAT THERE WAS A CERTAIN DEGREE OF PROMINENCE ASSOCIATED FOR THOSE THAT WON AN IMAP AWARD. SECOND THAT THE THREE YEAR R21 ENTIRELY UNIQUE FEATURE OF THE IMAP PROGRAM IN ALL OF NIH WAS WITH A POSITIVE FEAT AND YOU ARE SHOULD BE MAINTAINED AND AS DR. GRAY ALLUDED THERE WAS A REQUESTED NCI AS MUCH AS A 50% INCREASE, AND THIS PROGRAM, AND IMPRESS UPON THIS BOARD, THE BROAD PARTICIPATION ACROSS NCI, PARTICIPATION FROM EACH OF THESE DIFFERENT GROUPS FROM INDIVIDUALS WE FEEL CRITICAL FOR DOING A PROPER ASSESSMENT OF NOVELTY AND POTENTIAL IMPACT AND WITH THAT I TANK YOU FOR YOUR TAME--THANK YOU FOR YOUR TIME AND AM HAPPY TO ANSWER ANY QUESTIONS YOU MAY HAVE. >> AND THANK YOU FOR YOUR RESENTATION, LET'S RETURN TO THE SUBCOMMITTEE AND THEN WE'LL OPEN IT UP FOR FURTHER QUESTIONS. >> JOE? >> NO, I'LL REITERATE THE FACT THAT TECHNOLOGY ADVANCES ARE REALLY DRIVING A LARGE AMOUNT OF BIOLOGY THESE DAYS AND I THINK THAT ESPECIALLY WITH THE DEMISE OF SOME OF THE TECHNOLOGY ORYEBTED, THIS IS REALLY EMERGING AS ONE OF THE FEW PLACES WHERE PEOPLE CAN GO TO GIVE MONEY FOR TECHNOLOGY DEVELOPMENT. I THINK IT'S--AS FAR AS I CAN TELL, THE PROJECT HAS BEEN INCREDIBLY PRODUCTIVE AND INNOVATIVE AND HIGH RISK AND I THINK THAT ALL OF THOSE THINGS ARE BENEFICIAL. AND THAT WAS MY ENTHUSIASM FOR REQUESTING AN INCREASE IN THE BUDGET NOT JUST A REISSUANCE. >> RECOGNIZING IT'S A ZERO SUM GAIN. >> OVERRULED. >> THAT'S WYOMING WE BROUGHT IT WITH SOME RELOCKETTANCE. >> YEAH, I WAS ALSO VERY ENTHUSIASTIC ABOUT THIS PROGRAM. JUST THE DIVERSITY AND BREDTH OF THE ENABLING TECHNOLOGY AND I GUESS WAS TUCKLY IMPRESSED BY THE PARTICULAR COMPANIES THAT HAVE BEEN DEVELOPING THESE TECHNOLOGIES FURTHER INCLUDING ISOMETRICS AND PROTEOMICS TECHNOLOGIES AND OTHERS THAT STARTED AT AN EARLY STAGE IN THE FORMAATIVE STAGES AND THEN TRANSFORMATION INTO ACTUAL COMMERCIAL PRODUCTS HAS BEEN VERY IMPRESSIVE. ASSOCIATE WIDE A HIGH NUMBER OF IMPACT PUBLICATIONS AS WELL, BUT IT'S BEEN A TREMENDOUS BANG FOR THE BUCK IN TERMS OF THE AMOUNT OF RESOURCES SPECT ON THIS EFFORT, I BELIEVE IT'S ABOUT 10 MILLION DOLLARS OR SO, COMPARED TO THE IMPACT IN TERMS OF COMMERCIALIZATION, POTENTIALLY JOBS CREATED AS PART OF THAT COMMERCIALIZATION I THINK HAVE BEEN TREMENDOUS RELATIVE TO SAY, MANY OF THE R&D BUDGETS OF VARIOUS PHARMA COMPANIES AND BIOTECH COMPANIES AND SO FORTH, THIS HAS HAD TREMENDOUS IMPACT RELATIVE TO POTENTIAL OTHER PROGRAMS. >> JOSH? >> IT'S ALWAYS HARD GOING FIRED BECAUSE I AGREE WITH BOTH OF THOSE. THE YEARS AGO, I HAD AN IMAP GRANT. FULL DISCLOSURE. WE WERE DEVELOP THANKSGIVING CRAZY IDEA OF DEVELOPING PROTEIN INSITU, CHIPS AND IT HELPED US TREMENDOUSLY AND SINCE THEN WE GOT NUMEROUS GRANTS AND PAPERS OUT OF THIS. BUT JUST TO EMPHASIZE THIS, IT'S NOT THE ONLY GAME IN TOWN IN TERMS OF NCI, BUT ONLY THE GAME IN TOWN FOR NIH. IT'S THE ONLY PLACE PEOPLE CAN GO WITH CREATIVE IDEAS AND CREATE NOW NECKATOLOGYS AND GET THEM FUNDED FOR THE MOST PART BECAUSE IT'S HARD TO GET FUNDED TO DO TECHNOLOGY DEVELOPMENT SO THIS IS A POWERFUL PROGRAM. IT SOUNDS LIKE THERE'S ENUSEIASM, LET'S OPEN IT UP FOR FURTHER DISCUSSION. >> IN LIGHT OF THE GAME, IS THERE ANYWAY YOU CAN SET A LICENSING AGREEMENT WHERE THERE'S A KICK BACK TO THE POTENT STATE? >> WELL-- >> WELL THERE'S CLEARLY SUCCESSES BUT THAT'S SOMETHING TO CONSIDER IF THIS PROGRAM HAS BEEN SUCCESSFUL WHICH IT APPEARS TO BE AND WILL CONTINUE TOU >> OVERTURNED BY GOALS. [LAUGHTER] >> OH WELL. >> GOOD TIME TO TAKE THAT ON. >> MIKE, ARE WE BANDING THESE INNOVATIVE PRODUCTS TOGETHER TO GET THEM OUT TO THE FOLKS IN THE COMMUNITY BECAUSE THE GOOD WANTS TO TALK ABOUT WHAT WE'RE DOING. YOUR IDEA ABOUT THE JOBS CREATION TO GET THAT OUT THERE, WHAT'S HAPPENING. ANYTHING FOR DOING WITH REGUARD TO THAT. >> WELL, CERTAINLY, WE--YOU KNOW, WE HAVE LIMITED MEANS TO DO THAT BUT WE CERTAINLY TRY TO PROMOTE THE PROGRAMS WE THINK ARE SUCCESSFUL, HAVING SUCH A BROAD PARTICIPATION FROM ACROSS NCI IS USEFUL FOR HELPING THOSE PRINCIPLE INVESTIGATORS UNDERSTAND HOW THEY CAN SUBSEQUENTLY FOLLOW UP WITH HYPOTHESIS DRIVEN RESEARCH, CERTAINLY TECHNOLOGY-- >> JUST AN E-MAIL TO NIH FUNDED INVESTIGATORS ABOUT WHAT CAN YOU DISCLOSE WHERE PEOPLE CAN GET ACCESS TO THE TECHNOLOGY, THAT'S ALL. >> NO, WE'RE CERTAINLY CONSIDERING HOW TO MAKE BETTER USE OF THE WEB SITE AND HOW THESE TECH NOT TO MY KNOWLEDGES CAN--TECHNOLOGIES CAN FIND MORE COLLABORATORS AND MORE WAYS OF DISSEMINATE WAG THEY PRODUCE. >> I WONDER IF I COULD ASK A QUESTION ABOUT THE HUNDRED% INVESTIGATOR INITIATED IDEA APPROACH WHICH IS A--IS A GREAT THING BUT I COULD ALSO IMAGINE, YOU KNOW A PROVOCATIVE QUESTIONS FOR TECHNOLOGIES WHEREBY THE COMMUNITY GETS TOGETHER A LIST OF PROBLEMS THEY REALLY THINK SHOULD BE SOLVED BECAUSE I BET THAT THERE ARE TECHNOLOGY DEVELOPERS WHO JUST DON'T KNOW WHAT THE MOST PRESSING PROBLEMS FOR FOR THE COMMUNITY. >> WE HAVE OUR MEETING SCHEDULED NEXT WEEK AND ONE OF THE THINGS I WAS HOPING TO DO IS SELECT A NUMBER OF THE PROVOCATIVE QUESTIONS TO SIS SEMESTERINATE AGAINST-OF DISSEMINATE THROUGHOUT OUR INVESTIGATORS AND HAVE FOOD FOR THOUGHT. >> NOW SOME OF QUIETS COULD FIT AN IMAP PROPOSAL. IT DOESN'T MAKE TOO MUCH DIFFERENCE WHETHER THAT'S FUNDED IN LIGHT OF THE QUESTIONS, RFA OR THIS ONE. I ALSO THINK WE HAVE TO REMEMBER THAT AN RNA THAT PROBES THE REAL NEED AND IS FAIRLY OPEN IN DESIGN IS NOT MARKEDLY DIFFERENT FROM HAVING A TOTALLY FREE INVESTIGATOR INITIATED RPGPOOL SO I DON'T THINK WE SHOULD FEEL THAT WHEN WE SAY THAT WE'RE GOING TO ENDORSE A PROGRAM LIKE THIS THAT WE'RE TAKING AWAY SOMETHING FROM THE REST OF THE POOL. OTHER COMMENTS. >> SO IT SOUNDS LIKE THERE WAS A LOT OF ENTHUSIASM FOR THIS. WE SHOULD BE VOTING ON THE PROPOSAL AS PROPOSED AT THE FUNDING LEVEL PROPOSED BY STAFF, WE CAN THEN COME BACK TO WHETHER TAKE THE BOARD'S TEMPERATURE ON WHETHER THERE'S ENTHUSIASM FOR NCI GIVING EVEN MORE SUPPORT FOR THIS UNDERSTANDING BUT IT IS A ZERO SOMETHING GAIN BUT THE PROCEDURAL VOTE IS WHAT HAS BEEN PROPOSED. >> SO JUST A POINT OF INFORMATION, ARE THESE GRANTS IMAP GRANTEDS REVIEWED IN THE STUDY SECTION THAT ARE CONCERNED WITH TECHNOLOGY. >> OKAY, IS THERE A MOTION FOR A CONCURRENCE? >> SECOND? >> ANY FURTHER DISCUSSION? ALL IN FAVOR? OPPOSED? OBLIGATIONS--ABSTENTIONS? >> O SHOW OF HANDS. SO HOW AS A WAY OF PROVIDING INPUT TO THE STAFF, IS THERE ENTHUSIASM FOR THE PROPOSED 50% OR SOME ADDITIONAL FUNDING LEVEL FOR THIS PROGRAM? >> PLEASE? >> BEFORE THEN, ONE OF THE CRITERIA FOR EXPANDING THIS WOULD BE, I THINK YOU MENTIONED THIS THAT THERE ARE A LOT OF PEOPLE WHO HAVE BEEN SHUT OUT OF THIS WHO HAVE VERY, VERY GOOD SCORES, STILL. SO IS THERE ANY DATA WE COULD LOOK AT LOOKING AT THOSE SCORES OVERALL. >> TO SEE WHETHER THE WE'RE MAKE THANKSGIVING CUT OFF, A LARGE POOL OF QUALIFIED PROPOSALS THAT ARE GETTING SHEET OUT OF THIS. >> SO THE DEGREE OF REVIEW, OVER THE COURSE OF THIS PAST SUMMER IN PREPARING FOR THIS, BY AND LARGE, THE SPECIAL EMPHASIS PANEL TAKE THE WINNERS OUT OF THE POOLS OF APPLICATIONS, IT'S QUITE WELL AND WHEN YOU DIP TWO OR THREE OR FOUR APPLICATIONS DOWN, YOU FIND SUCCESS STORIES WITHIN THOSE SELECTIONS BUT, BY AND LARGE, THE BIGGER SUCCESS STORIES AND TOP GIVEN REVIEW, THAT'S SOMETHING WE'RE LOOKING FURTHER INTO TO UNDERSTAND WHAT IT IS ABOUT THE ONES AND IDENTIFY THE ONES THAT MAY STRIKE THE PANEL WITH A LITTLE BIT MORE BUT STILL HAVE INCREDIBLE ATTENTION SO WE'RE IN THE PROCESS OF REVIEWING THAT. >> WE'RE NOT OBLIGATED TO SPEND MONITOR THAT'S IS QUOTE SET ASIDE FOR THIS PROGRAM. SO IF WE DON'T HAVE APPLICATIONS THAT THE VERY HIGH STANDARD WE CURRENTLY HAVE TO EXERT, THE MONEY GAS BACK TO THE RPG POOL. SO WITH THAT IN MIND, IS THERE A MOTION TO RECOMMEND THAT THE NCI CONSIDER AN INCREASE OF SOME APPROPRIATE AMOUNT NOT TO BE SPEC SPECIFIED HERE, INCREASE THE AMOUNT OF FUNDING EAR MARK FOR THE IMAP PROGRAM? >> SECOND. >> ANY FURTHER DISCUSSION. >> I WOULD LIKE TO SPEAK BACK TO VIC'S POINT THAT WE DON'T HAVE THE DATA THAT LETS US KNOW IF THAT INCREASE IS BENEFICIAL. WOULD IS IDENTIFY THE APPLICATIONS THAT ARE GREAT THAT ARE NOT GETTING FUNDED. WE REALLY DON'T KNOW THAT. >> NO, WE DON'T REALLY KNOW THAT. WE CERTAINLY FEEL WE ARE MISSING OUT ON POTENTIALLY PROMISING PROJECTS BECAUSE THE BUDGET IS STRETCHED TIGHT AS IT IS. SO WE FEEL THAT EXPANDING AND DO SCORE HIGHLY AND YIELD NOR SUCCESS STORIES BUT WE DON'T KNOW SPECIFICALLY IF THERE'S ANYTHING ABOUT DIPPING DEEPER INTO THE POOL THAN THE VERY HIGH SCORES THAT COULD-- >> LET ME ASK A QUESTION DIFFERENTLY WOULD THE NEXT IMAP GRANT BE BETTER THAN THE NEXT RO-1 THAT DIDN'T GET FUNDED. >> DOUG DO YOU WANT TO COMMENT ON THIS? >> I THINK IT'S DIFFICULT TO SPECULATE ON THE SUCCESS OF APPLICATIONS THAT WERE NOT FUNDED. I'M NOT TRYING TO SUGGEST THAT IGNORANCE IS BLISS, BUT WHAT TONE SESAYING THAT THERE ARE APPLICATIONS THAT SEEM TO BE MERITORIOUS. I'M NOT SURE IT'S NECESSARY TO CALL A VOTE ON THIS. I THINK NCI REALIZES IT'S NOT GOOD TO WEIGH-IN ON A DOLLAR AMOUNT BUT WHAT THE BOARD IS STRUGGLING WITH IS TO UNDERSTAND HOW IS IT THAT 10 MILLION DOLLAR CAME TO BE THE RIGHT NUMBER FOR THIS PROGRAM. WHY ISN'T FIVE, WHY ISN'T IT 25 IN THE BIG PICTURE AND ASPIRE TO BRING-- >> I APPRECIATE THAT COMMENT BECAUSE AS YOU KNOW FROM MY EARLIER COMMENT, WE DONE KNOW WHAT NEXT YEAR'S GOING TO LOOK LIKE. THAT'S NOT THE NEXT YEAR, THIS YEAR IS GOING TO LOOK LIKE. BUT THESE CAN GO OVER THE SBIR, RIGHT? IF THEY'RE NOT FUNDED-- >> YEAH, BUT THE COMPANY, VERY FEW ARE ACTUAL COMPANY GRANTS. >> IT REQUIRES TAKING AN EXTRA STEP. >> YEAH, THE LARGE MAJORITY ARE FROM ACADEMIC INVESTIGATORS. >> YES BUT HAVING SUBHITTED AN SBIR, THERE'S A LOT OF THOSE PEOPLE OUT THERE. >> SURE. >> ONE LAST COMMENT IS THAT IS TOO MY TASTE, THIS IS ONE OF THE FEW PROGRAMS IN THE NCI WHERE RISK ACTUALLY DOES GET REWARDED. THIS REVIEW PROCESS DOES PICK OUT HIGH RISK HIGH REWORRIED PROGECS IN A WAY THAT MOST OTHERS DON'T AND THAT'S ONE OF THE REASONS I'M ENTHUSIASTIC ABOUT IT IS YOU KNOW WE WOULD LIKE A LOT OF OUR RO-1S TO BE DOING THIS BUT THIS PROGRAM SUCCEEDS PARTICULARLY WELL IN THAT REGUARD. OKAY, THANK YOU VERY MUCH. >> OUR LAST RFA TO CONSIDER BEFORE THE LUNCH BREAK IS FOR THE PEDIATRIC PHASE ONE CONSORTIUM ANY INTRODUCTORY COMMENTS, YOU ARE THE CHAIR? MALCOM WILL GIVE A SHORT PRESENTATION. >> NO, WE JUST ASKED FOR A PRESENTATION TO SET IN THIS CONTEXT CLEARLY AT THIS TIME IN HISTORY, AS WELL A NEED FOR PEDIATRIC PHASE ONE DRUG DEVELOPMENT TO TRY TO MAKE THE RUBBER HIT THE ROAD BETTER. BUT WE HAD SEVERAL QUESTIONS, AND IT WAS CLEAR THAT NCI STAFF COULD ANSWER THEM FOR THE COMMITTEE SO WE THOUGHT THE BOARD SHOULD HEAR THIS. >> THANK YOU FOR THE OPPORTUNITY TO THINK ABOUT THE REISSUANCE OF THE POODIATRIC PHASE ONE PILOT CONSORTIUM RFA, I RECOGNIZE THAT I STAND BETWEEN YOU AND LUNCH SO I'LL TRY TO BE IS SUCCINCT IN MY COMMENTS IN DESCRIBING THE CONSORTIUM. I THINK MOST PEOPLE IN THE ROOM ARE MORE FAMILIAR WITH ADULT PHASE ONE TRIALS AND HOW THOSE ARE ACCOMPLISHED THAN PEDEIATIC PHASE ONE TRIALS. CHILDREN ARE DIFFERENT NOT ONLY PHYSIOLOGICALLY AND CLINICALLY BUT ALSO THEIR CONFERENCES IN TERMS OF HOW PHASE ONE TRIALS ARE DONE. ONE DIFFERENCE IS THE ADULT PHASE ONE TRIALS IN THE NCI SUPPORTED PROCESS FOR ADULT PHASE ONE TRIALS PRIMARILY THE SINGLE INSTITUTION PROCESS WHERE MULTIINSITU TUITIONAL TRIALS ARE THERE AND BECAUSE OF THAT, ANYTIME YOU HAVE MULTIINSTITUTIONAL TRIALS THERE'S AN INFRASTRUCTURE YOU HAVE TO BUILD INTO THAT IN TERMS OF SITE STRAINING, STUDY MONITORING, IMP PLEA MENTORSHIP SKILLING UNIFORMITY ACROSS ALL THE SITES. A SECOND DIFFERENCE IS THE ETHICAL ISSUES THAT LIMIT THE RISK TO WHICH CHILDREN PARTICIPATE NOTHING RESEARCH STUDIES CAN BE SUBJECTED. AND SO THE KIND OF THINGS THAT HAPPEN IN ADULT PHASE ONE TRIALS WHERE THEY'RE TIMED, TUMOR COLLECTIONS AFTER RECEIVING A TARGETED DATA SO CAN YOU LOOK AT THE EFFECT ON THE TARGET. THOSE SIMPLY CAN'T BE DONE IN THE PEDIATRIC SETTING EXCEPT IN VERY RARE SITUATIONS. AND SO WE HAVE TO HAVE OTHER WAYS OF LOOKING AT DRUG ADMINISTERS AND DRUG EFFECT SO FINALLY A PHARMACEUTICAL INTEREST COMPARED TO ADULT SET SUGGEST MORE LIMITED SO THERE IS A LIM THE TED NONNIH FUNDING STREAM FOR DRUG DEVELOPMENT AND NCI PLAYS A UNIQUE ROLE IN SUPPORTING THE SEAMS OF EXPERIENCE INVESTIGATORS THAT ARE NEEDED TO SAVELY EFFICIENTLY BRING NEW AGENTS INTO THE PEDIATRIC SETTING. NOW, OUTCOME HAS IMPROVED MARKEDLY FOR CHILDREN WITH CANCER OVER THE LAST FOUR DECADES AND THERE ARE A NUMBER OF CANCERS NOW FOR WHICH FIVE YEAR SURVIVAL RATES ARE AT 90% OR ABOVE OR APREACHES 90%, ALL, HODGE KIN, WIL'MS, NONHODGE KIN LYMPHOMA BUT OTHERS FOR WHICH OUTCOMES ARE NOT SO GOOD AND THERE ARE A COUPLE ELOGY OF POINTS TO NOTE, AND THIS IS LOOKING AT MORTALITY RATE ACROSS THE UNITED STATES FROM 1975 THROUGH ABOUT 2006. CERTAINLY THE MARK IS LESS SO FOR THE SOLID TUMORS BUT ONE IS THE RATE OF IMPROVEMENT, THE RATE OF IMPROVING OUTCOME HAS SLOWED OVER THE LAST DECADE AND THE SECOND SPOINT THAT THESE ARE NOWHERE CLOSE TO ZERO RIGHT NOW AND THESE SCORES WOULD REPRESENT APPROXIMATELY 2000 CHILDREN FOR WHOM OUR CURRENT TREATMENTS ARE NOT ADEQUATE TODAY. SO HOW DO WE GO ABOUT DEVELOPING MORE EFFECTIVE TREATMENTS FOR CHILDREN WITH CANCER. AND THIS OUTLINES SCHEMATICALLY THE PROCESS FOR DOING THAT BEGINNING WITH THE TARGET DISCOVERY PROGRAMS AND PARTICULARLY THE GENOMIC LOOKING FOR THE GENOMIC ALTERATIONS THAT WOULD IDENTIFY DRIVER MUTATIONS, WE HAVE TARGET PROGRAMS SPONSORED BY NCI, OTHER PROGRAMS SUCH AS ST. JUDE WASH-URKS, CANCER PROJECTS ALL OVER THE WORLD. THAT ARE LOOKING FOR THESE RECURRING GENOMIC ALTERATIONS GOING FROM THE ALTERATIONS TO PRECLINICAL TESTING TO PROVIDE A FURGTSER PRIORITIZATION--FURTHER PRIORITIZATION FOR AGENTS AND GOING TO A DEFINITIVE TRIAL THAT WE HOPE WILL BE POSITIVE BUT A KEY STEP IN GOING FROM THIS TARGET PRECLINICAL EVALUATION, THE TRIAL IS THE PHASE ONE CONSORTIUM. AND SO THAT,'S WHAT WE'RE TALKING ABOUT TODAY. IN TERMS OF NCI SUPPORT, SINCE 1992, NCI SUPPORTED A PEDIATRIC PHASE ONE ACTIVITY IN THE OLD OLD DAY FIST WAS THE CHANCER GROUP IN THE PEDIATRIC ONCOLOGY GROUP WITH THE MERGER TO FORM COG, IT'S BEEN THE COG PHASE ONE CONSORTIUM SINCE 2002 AND NCI DOES PROVIDE THE PRIME'S ARE SUPPORT FOR PHASE ONE TRIALS AND NORTH AMERICA AND AGAIN THERE IS THE ONGOING NEED, WE HAVEN'T SOLVED THE PROBLEM OF CHILDHOOD CANCER. SO, HIGHLIGHT SOME CONTRIBUTIONS OF THE CONSORTIUM OVER THE LAST FEW YEARS BUT I WOULD ALSO POINT TO THE CONTRIBUTIONS THAT COULD BE ANTICIPATED IN THE COMING YEARS AND THESE ARE FOUR PHASE ONE TRIALS THAT ARE ONGOING, I WANT TO SAY MORE ABOUT THE KINASE INHIBITOR OR THE VALLEY VIRUS, ONK O LYTIC STUDY, THESE WERE TRY TAG WERE GIVEN BY MARKED PRECLINICAL ACTIVITY IN THE CONSORTIUM ACTIVITY, AND IN THIS CASE AGAINST THE SUBSTANTIAL LODGISTICAL ISSUES, THEY'RE ONGOING. BUT, TO LOOKING AT THE FIRST TWO AND STARTING WITH THE JACK PHASE ONE TRIAL AND JACK INHIBITOR FADES ONE TRIAL, BUT THE JACK INHIBITOR TRIAL BECAME OF INTEREST BECAUSE OF THE DISCOVERY IN THE TARGET PROGRAM THAT JACK MUTATION OCCURRED AND APPROXIMATELY 10% OF CASES OF HIGH RISK PRECURIOUS ORA. L. L.s THESE HAD A BCR ABLE LIKE GENE EXPRESSION PATTERN AND WHEN THOSE CASES WERE LOOKED AT IN DETAIL, ABOUT HALF OF THEM HAD JACK MUTATIONS, MOSTLY JACK TWO, MOSTLY IN THE KINASE DOMAIN, BUT OCCASIONALLY THE MUTATION AS WELL, AND STIMULATED, THE CLG A. L. L. COMMITTEE AND THEN WORK IN COLLABORATION WITH THE CONSORTIUM, DEVELOP THE SAME ONE INHIBITOR, AND THIS START INDEED SEPTEMBER 2010 AND COLLABORATION WITH THEM AND IT'S A DRUG THAT'S MOVING FORWARD, AND THE ADULT SETTING THE CAUSE OF THE MILE O FIBROSIS INDICATION WITH JACK TWO MUTATIONS AND MUTATIONS BEING PROMINENT IN THAT CONDITION SO THIS AGENT WAS PICKED BECAUSE IT APPEARED TO BE MOVING TO THE CLINIC AS FASTER, FASTER THAN ANY OF THE OTHER AGENTS, THE CONSORTIUM QUICKLY GOT A STUDY GOING, THIS STUDY IS ONGOING BUT THE INTENT ASSUMING THE PHASE ONE STUDY GOES WELL, PRECLINICAL TEST SUGGEST SUPPORTIVE AND MOVING FORWARD, THE INTENT WOULD BE FOR COG TO TAKE THE JACK INHIBITOR COMBINE IT WITH A STANDARD MODERATELY EFFECT THERAPY FOR THIS SUBTYPE OF AAL. L. AND DO SOMETHING SIMILAR TO THE AMAT NIB BCR ABLE STORY WHERE OUTCOMES FOR TH-POSITIVE A. L. L. IN CHILDREN IMPROVED DRAMATICALLY WITHIN THE ADDITION OF AMAT NIB TO STAND ORD CHEMO THERAPY. THE OTHER EXAMPLE WAS DRIVEN BY TWO THINGS. DISCOVERY IN 2008, FAMILIESIAL BLASTOMA GENE, A NUMBER OF THIS REPORT WAS DONE AT THE SAME TIME, HERE IS THE REPORT FROM JOHN MARIS' GROUP, IT WAS NOT ONLY THAT A. L. L. IS A NEUROBLASTOMA GENE BUT THERE ARE MUTATIONS IN THE KINASE DOMAIN AND SPORATTIC OCCASION AND OCCASIONALLY AMPLIFICATION AS WELL, SO PERHAPS 10% OF NEURAL BLASTOMA HAS EVIDENCE OF MUTATION THE OTHER ISAL AN ALK INHIBITOR, IS THE MUTATED TRANSLOCATED TUMORS AND THE ALK IN A LARGE CELL LYMPHOMA THRK IS THE PFIZER DRUG AND ALK INHIBITOR AND SHOWN HERE IS THE PRECLINICAL DATA FROM JAMES CRIST PEN SENSE IN THE FIRST AUTHOR IN THIS REPORT FROM PFIZER, SHOWING THE DOSE OF A HUNDRED MEGS PK INDUCED RAPID REMISSION AND REGRESSION OCCURRED. THESE HAPPEN AT A DOSE OF PLASMA CONCENTRATION THAT WAS ACHEWABLE IN YOU HAD HUMANS. SO THIS WAS A HIGH PRIORITY TO MOVE FORWARD, NOT ONLY FOR NURRAL BLASTOMA BUT ALSO FOR THE PEDIATRIC CANCERS. C. O. G. WORKS WITH PFIZER STARTED PHASE WOG STUDY IN SEPTEMBER 2009. THAT STUDY IS NEARING COMPLETION NOW. ONE ASPECT OF THE STUDY WAS THAT ANY CHILD HAD BEEN OUTMUTATED OR OUTTRANSLOCATED TUMOR COULD ENTER THE STUDY WITH THE DOSE LEVEL WHETHER IT'S IT WAS EVAL YAGS FOR THE DOSE LEVEL AND AS A RESULT THERE HAVE BEEN A HANDFUL OF PATIENTS WITH LARGE LYMPHOMA ENROLLED AND ALL OF THOSE PATIENTS ACHIEVED OBJECTIVE RESPONSES, PC R SO THERE'S A HIGH PRIORITY NOW TO MOVE FORWARD INTO PHASE THREE TRIALS. THE OTHER CONTRIBUTIONS TO PAY ATTENTION TO ARE THE ROLE OF THE SON SORTIUM AND DATA SET FOR AND EVALUATION AND HANDLE DIFFERENTLY BY CHILDREN, THE PHARMACOKINETICS WILL BE DIFFERENT IN CHILDREN COMPARED TO ADULTS. THE POSSIBILITIES THAT THE SAME EXPOSURES THAT CHILDREN WILL HAVE DIFFERENT PHARMACODYNAMICS IN TERMS OF ADVERSE EFFECTS AND SO THE CONSORTIUM IS REALLY DEVELOPS THE DATA--THE PHARMACOKINETIC DATA SET, IS REALLY THE SUBSEQUENT TESTING OF THE AGENT IN CHILDREN. , THE PHASE ONE STUDIES REALLY DO FORM THE BASES FOR THE SUBSEQUENT STUDIES THAT COG CONDUCTS CALLING ATTENTION TO THE SERAT NIB PHASE TRIAL AND THIS IS IN THE FRONT LINE SETTING FOR A GOOD THREE POSITIVE AML AND THEN A NUMBER OF AGENTS THAT TRANSDITION TO PHASE TWO AND THEN ALIT MID, THE MELLENIUM KINASE INHIBITOR AND THEN HER MAT NIB MOVING TO THE FRONT LINE FOR POSITIVE A. L. L. SO THE UB COMMITTEE HAD SEVERAL QUESTIONS, IMPORTANT QUESTIONS TO ADDRESS ABOUT THE WAY THIS RFA IS STRUCTURED AND ONE WOULD IT BE A MORE EFICIENT USE TO PUT THE PHASE ONE CONSORTIUM TOGETHER WITH THE OG. THE FIRST POINT TO MAKE IN RESPONDING TO THIS IS THAT THE CONSORTIUM IS ALREADY NEEDED IN APPROPRIATE WAYS. SO THE CLINICAL DATA MANAGEMENT SYSTEM THAT COG USE SYSTEM USED BY THE PHASE ONE CONSORTIUM, PROTOCOL DEVELOPMENT RECORPSS AND THE INFRASTRUCTURE FOR PROTOCOL DEVELOPMENT, COG HAS, IS USED BY THE CONSORTIUM, THE COG MEETINGS ARE WHERE THE CONSORTIUM MEETINGS PREDOMINANTLY CONSIDER. OTHER POINTS IN TERMS OF THE APPROPRIATE EPITHELIALIGRATION STUDY CAN START AT A PHASE ONE CONSORTIUM STUDY AND TRANSITION SEAMLESSLY TO A C. O. G. GROUP-WIDE STUDY SO GO FROM 20 INSTITUTIONS SEAMLESSLY AND ANOTHER EXAMPLE IS WHEN THEY'RE PARTICULARLY INSTITUTIONS WITH EXPERTISE, YOU KNOW WITHIN COG THAT AREN'T IN THE CONSORTIUM, THEY CAN BE ADDED TO SPECIFIC STUDIES AND THERE'S APPROPRIATE INTEGRATION WITH COG. AN IMPORTANT POINT THAT THEY DO ON PHASE TWO AND THREE STUDIES THAT THEY DO ON COG IS THE MONITORING AND DATA AND IT'S REALLY A SMALL NUMBER OF PATIENTS, A NUMBER OF PARTICIPATING INSTITUTIONS AND THE EMPSCIZZ KNOWN AS PKD IMAGES END POINTS AND IF COG DID THIS, THEY VALID TO REPALATEICATE THE STRUCTURE AND THERE WAS REALLY LITTLE OR NO BUDGETARY SAVINGS FROM INCORPORATING THE CONSORTIUM INTO THE COG UNDER THE ASUSMTIONZ THAT THE WORKS THAT GO BY ISN'T CHANGED THE FLIP SIDE OF THAT QUESTION IS WHAT IS GAINED, AND HAVING THE DISTINCTION AND I WOULD REALLY EMPHASIZE THE MOST IMPORTANT POINT IS THAT, HAVING IT DISTINCTIVE ALLOWS US TO FOCUS AND ALLOWS PEER REVIEW TO FOCUS ON WHETHER THE CONSORTIUM IS REALLY CONDUCTING ITS PHASE ONE TRIALS IN THE WAY THAT'S REQUIRED FOR AGENTS TO MOVE QUICKLY AND EFFICIENTLY AND AND SAFELY INTO THE PEDIATRIC SETTING. ALLOWS US TO LOOK AT DATA MANAGEMENT PROCEDURES THAT ARE AND PHASE TWO AND PHASE THREE, HOW THE PK STUDIES OR NPD STUDIES ARE INTEGRATED AND IS THE CONSORTIUM HIGHLY CONDUCTED WITH THE RESOURCES THAT ARE PROVIDED. YOU KNOW THE RISK IF YOU FOLD IT PHASE ONE STUDIES INTO COG WOULD BE THAT THIS IS A SMALL PERCENTAGE OF COG STUDIES AND COG LIKE ANY COOPERATIVE GROUP, REAL LE DEPENDS ON THE LARGE. THE INSTITUTIONS NEED THE PHASE THREE STUDIES OPEN. THEY NEED THE LARGE PHASE TWO STUDIES OPEN IN ORDER TO ENROLL PATIENTS. WHAT THE COOPERATIVE GROUPS MAKE THEIR LIVING DO SUGGEST THE FACE TWO AND PHASE THREE STUDIES SO THERE'S THE VERY REAL RISK THAT PHASE ONE STUDIES WOULD BE DEEMPHASIZED BUT CALL THE COGs APPROPRIATE IMP SIS ON PHASE TWO AND PHASE THREE STUDIES. AND IN EMERGINGS OF BUDGET CONSIDERATION, THE REQUEST IS FOR A FLAT BUDGET COMPARED TO A FISCAL YEAR 10 AND THE ONE IS WHAT ONE WOULD EXPECT FROM A STATISTICAL DATA MANAGEMENT, ET CETERA. SO THEN CONCLUDING, THE FACE ONE CONSORTIUM IS THE PHASE ONE CLINETAL TRIALS FOR ABET CANCER AGENTS. MY COLLEAGUES AT OTHER INSTITUTES TELL ME THIS IS THE MODEL FOR HOW THE CHILDREN STUDIES ARE DONE. THE CONSORTIUM HAS A RECORD OF ACCOMPLISHMENT IN TERMS OF PROTOCOLS AND PATIENTS ENROLLED, PRESENT ANTICIPATIONS, CONTRIBUTIONS, TO COG CASE STUDIES AND FACTORY AND BUILDING THE NEXT GENERATION OF INVESTIGATORS, AND INTEGRATING NEW IMAGING METHODS INTO THE PEDIATRIC PHASE ONE TRIALS AND FINDING THE SON SORTIUM IS NEEDED SO THAT CHILDREN CAN BENEFIT FROM THE ADVANCES IN CANCER BIOLOGY AND DRUG DEVELOPMENT THAT WILL CONCERN IN THE COMING YEARS. I'LL BE GLAD TO ADDRESS QUESTIONS AFTER ANY COMMENTS. >> THANK YOU. >> SO TO SUMMARIZE, MALCOM HAS RESPONDED NICELY IN WRITING TO THE SUBCOMMITTEE AND IN PRESENTATION HERE TO ANSWER OUR PROBES AND HE'S SHALL I SAY DEFEATED OUR ATTEMPTS TO REENGINEER OR MICROMANAGE THE RFA AND I AM STRONGLY IN FAVOR OF IT. >> MARRYY? >> --MARRY? >> WE'RE SUPPORTIVE OF THIS RFA REISSUANCE. >> TED. >> NOT A HARD NAME, TED TRIMBLE. >> IT'S EASY. >> SO I WOULD AGREE--[LAUGHTER] I WILL MAKE ONE OTHER BRIEF POINT IS THAT BY HAVING A CONSORTIUM, WE WOULD HAVE AN INSTITUTION THAT WAS QUITE EXPERT IN ONE OF THE ASSAYS OR DRUGS BUT THEN THE WORDING OF THE RFA INCLUDES THAT SO IF YOU'RE NOT IN THE CONSORTIUM BUT YOU COULD DO THE WORK IN THIS IMPORTANT AREA TO YOU, THAT INSTITUTION COULD PARTICIPATE. SO I SUPPORT THIS STRONGLY. >> YEAH, VERY TIMELY. THE QUESTION I HAVE THOUGH, IS YOU EMPHASIZE THE PHARMACODYNAMICS AND THAT'S ONE OF THE IMPORTANT ASPECTS OF THIS BUT FOR THAT YOU WOULD HAVE TO HAVE BIOSPECIMENS. HOW IS THAT INCORPORATE INDEED THE STRATEGIES. >> I THINK THERE ARE TWO RESPONSES TO THAT. ONE, THE POINT THEY EMPHASIZED ABOUT THE ABILITY TO COLLECT, TIME, TUMOR SPECIMENS PREAND POST TREATMENT IS RARELY POSSIBLE IN THE PEDIATRIC SETTING AND AND SO YOU JUST DON'T--THAT'S KIND OF OFF THE TABLE. I THINK THE TWO THINGS YOU HAVE TO DO TO MAKE UP FOR THAT REALITY NUMBER ONE THE PHARMACOKINETICS BECOMES VERY IMPORTANT AND SO, IF ADULT CANCER RESEARCHERS HAVE SHOWN THAT WHEN YOU HAVE A SYSTEMIC EXPOSURE OF X, YOU'RE MODULATING THE TARGET IN AN APPROPRIATE ADULT CANCER THAT EXPRESSES THE TARGET, THEN WE NEED TO BE SURE THAT WITH OUR PHARMACOKINETIC STUDIES THAT WE ARE USING A DOSE THAT IS ACHIEVING A COMPARABLE SYSTEMIC EXPOSURE OR C-MAX OR WHATEVER THE RELEVANT PK VALUE IS. THE OTHER POINT IS, YOU DEPEND ON THE PERIPHERAL BLOOD, MONONEW CLEAR BLOOD, THE EXTHAT HE WENT THEY MAY BE INFORM FORMAATIVE OR SERUM FACTORS, PLASMA FACTOR K'S BE READ OUT FOR PHARMACODYNAMIC EFFECTS EFFECTS AND THOSE ARE THE KIND EVER STUDIES THAT ARE FEASIBLE AND THE PEDIATRIC PHASE ONE SETTING. >> WHAT HE'S THE INTERACTION OF THIS GROUP? IT'S MISLEADING TO CALL THIS COG PHASE ONE--BECAUSE AT LEAST AS I READ IT, YOU THINK IT'S UNDER COG, BUT THAT'S-I WOULD PROBABLY EXTRACT THAT IN THE NEXT TIME YOU PRESENT IT. BUT IT'S RELATIONSHIP TO THE PEDIATRIC TRKS CGA, I MEAN THAT SHOULD BE THE HAND AND TBLOF. THAT WOULD BE WORKING CLOSELY TO THOSE TWO GROUPS, BOTH FOR OBVIOUSLY THEY'RE DEFINING THE TARGETS OR THE POTENTIAL TARGETS AND THIS GROUP IS THEN COMING UP WITH THE AGENT TO TARGET THE SPECIFIC MUTATION OR WHATEVER. >> AND YOU KNOW FOR THE EXAMPLE I GAVE THE JACK TWO STORY, STEVE HUNGER IS IN THE TARGET PROJECT WITH THAT. STEVE GOT REAL EXCITED AND MINION LOW AND THE GROUP IN THE A. L. L. COMMITTEE AND TOGETHER WITH THE NCI STAFF, WORKED WITH SUSAN LANE FREE RADICALS THE PHASE ONE CONSORTIUM TO QUICKLY GET, FIND AN APPROPRIATE INHIBITOR TO THE PHASE ONE SETTING AND THE ALK INHIBITOR, AND JOHN MARIS BRINGING BASICALLY THE KRESOT NIB INTO THE CONSORTIUM. THE OTHER LINK THAT'S IMPORTANT IS THE PRECLINICAL TESTING RESULTS SO THERE'S A CLOSE INTERACTION BETWEEN YOU KNOW THE RESULTS FROM THE PRECLINICAL TESTING PROGRAM AND YOU KNOW SUSAN AND THE LEADERSHIP OF THE COD PHASE ONE CONSORTIUM AS WELL AS COG DISEASE COMMITTEES SO ALL OF THOSE LINES'VE COMMUNICATION ARE OPEN AND IN PART BECAUSE THE CONSORTIUM, YOU KNOW IS EMBEDDED WITHIN COG AND THE PARINGET INITIATIVE AS WELL AS REALLY EMBEDDED WITH THE COG DISEASE COMMITTEES THAT HAVE--THAT HAVE COLLECTED THOSE TISSUE SPECIMENS. >> SO MALCOM, I HAVE A QUESTION ABOUT HOW YOU SEE THE FUTURE OF PHASE ONE PEDIATRIC TRIALS EVOLVING. I MEAN CLEARLY THE GOAL OF THOSE TRIAL SYSTEM DOSE FINDING SAFETY ASSESSMENT BUT IT'S NOT GOING TO MAKE SENSE TO ENROLL PATIENTS WHOSE BASED ON MOLECULAR ANALYSIS DOESN'T MAKE--MIGHT NOT PLAUSIBLY BENEFIT AND SINCE WE'RE TALKING ABOUT RELATIVELY RARE TUMORS INCREASINGLY SMALL SEGMENTS OF THOSE PATIENT POPULATIONS HAVING PARTICULAR MUTATIONS ISN'T THAT CHALLENGE THE NOTION OF HAVING A SMALL NETWORK THAT DOES PHASE ONE STUDIES BUT THEN GOES TO PHASE TWO AS OPPOSE TO HAVING A LARGER GROUP OF YOU KNOW SITES THAT MAY ENROLL ZERO TO ONE PATIENT BUT YOU NEED TO HAVE THAT SIZE OF A NETWORK FOR PHASE ONE. >> NO, IT'S A GOOD POINT. I THINK ONE KIND OF RESPONSE OF THAT IS, YOU KNOW YOU LOOK AT THE ALK INHIBITOR, WELL IT'S A SMALL NUMBER OF PATIENTS BUT IT'S AN ALK INHIBITOR AND WHILE THERE'S PUBLISHED DATA THAT SYSTEM SARCOMA OR PEDIATRIC CANCERS MAY BE RELEVANT AND SO IN THAT CASE, I THINK THERE'S JUSTIFICATION FOR SAYING WE CAN ROLL ACROSS A BROAD SPECTRUM OF PEDIATRIC CANCERS. WHEN YOU GET TO SMALLER AND SMALLER SUBSETS AND MORE AND MORE SPECIFIC DRUGS, I THINK YOU'RE RIGHT THAT WE WILL--YOU KNOW OUR PHASE ONE STUDIES WILL HAVE VERY LIMITED DOSE BINDING, DEPENDING ON THE TOXICITY OF THE AGENT IT MAY BE A SINGLE DOSE WHERE YOU LOOK AT THE PK AND MAKE SURE YOU OBTAIN THE RIGHT EXPOSURES AND THEN, YOU KNOW YOU GET HOWEVER MANY INSTITUTIONS TOGETHER. YOU NEED TO DO THE STUDY. BUT THE CONSORTIUM IS ABLE TO DO, YOU KNOW IT'S 20 INSTITUTIONS AMONG THE LARGER ONES BUT IF THERE WERE A REASON, YOU KNOW IT COULD TAKE THE NEXT 20 LARGEST COG INSTITUTIONS AND SAY FOR THIS STUDY, WE REALLY NEED YOU TO PARTICIPATE IF YOU'RE WILLING TO. SO, THERE IS A FLEXIBILITY TO DO THAT AND YOU KNOW THE CONSORTIUM HAS DONE IT. >> OTHER QUESTIONS OR COMMENT SYMPATHETIC NERVOUS SYSTEM. >> SO GIVEN THE APPROPRIATE ABILITY TO OBTAIN SAMPLES POST TREATMENT TO LOOK AT LIGAND TARGET INTEROBJECTIONS, THAT REALLY RAISES THE ISSUE OF THE IMPORTANCE OF IMAGING AND HOW--BECAUSE THAT'S THE ALTERNATIVE OF COURSE. SO HOW ROBUST IS THE IMAGING CAPABILITY WITHIN THE CREW, HOW DO YOU SEE THAT EVOLVING. >> YOU KNOW WE DR. FINKER WILL HEAR FROM OUR IMAGES PROGRAM AND THE CONSORTIUM IN PART JUST TO TRY TO MAKE THE CAPABILITIES AS ROBUST AS POSSIBLE. YOU KNOW AT THIS POINT, THE INSTITUTIONS ARE ALL LINKED TOGETHER IN TERMS OF THEIR ABILITY TO DO THE APPROPRIATE MRI STUDIES WITH WHATEVER FUNCTIONAL ASPECTS THERE ARE AND SUBMIT THOSE DATA. YOU KNOW I THINK IT'S--IMAGE SYSTEM BUILT INTO THE CONSORTIUM. THERE'S FUNDING INCLUDED IN THE CONSORTIUM BUDGET FOR IMAGING, AND AS THE AGENTS COME THROUGH, I THINK WE'LL BE WORKING WITH DR. SHANKER AND COLLEAGUES TO INCORPORATE IMAGING. SO IT'S BEEN LOOK AT THINGS FOR VEG FAR INHIBITOR AND LOOKING FOR APPROPRIATE CHANGES AND ENHANCED MRI FOR EXAMPLE AND THE FUTURE, YOU KNOW WE HOPE TO KEEP UP WITH THE STATE-OF-THE-ART IN TERPS OF THE AGENT AND THE IMAGING OPPORTUNITIES POSSIBLE. NUMBER ELSE, IS THERE A MOTION TO CONCUR WITH REISSUANCE. >> SECOND? >> FURTHER DISCUSSION? >> ALL IN FAVOR? , OOPPOSED? >> ABSTENTION? YOU NANOG MOUSE AGAIN AND ENTHUSIASTIC CROWD TODAY. >> [LAUGHTER] >> SO GIVEN WE'VE BEEN EFFICIENT, LET'S TAKE A ONE HOUR BREAK AND START AGAIN AT 1:00 O'CLOCK INSTEAD OF 1:30. >> OKAY, I WOULD LIKE TO HAVE AN ADMINISTRATIVE SESSION WITH THE BOARD, SO I WOULD LIKE FOR EVERYBODY ELSE TO LEAVE THE ROOM. YOU MAY LEAVE YOUR BELONGINGS AND THEN COME BACK AT 1:00 O'CLOCK. OKAY BUT THE BOARD GO GET YOUR LUNCH IN CONFERENCE ROOM NINE AND COME BACK TO THIS ROOM. >> HE SAYS COME BACK IN 15 MINUTES. OKAY. SO THAT THE NEXT TASK IS TO CONSIDER THE ISSUANCE OF A NEW RFA RELATING TO A REVAMPED CLINICAL TRIAL COOPERATIVE GROUP EFFORT, I THINK THIS EXCITING OPPORTUNITY FOR THE NCI TO THINK ABOUT HOW TO REIMAGINE CLINICAL TRIAL NETWORKS FOR CANCER. BECAUSE OF THE IMPORTANCE OF THIS, OBVIOUSLY BECAUSE OF THE SIZE OF THE BUDGET THAT'S ON THE TABLE IT'S APPROPRIATE THAT WE SPEND MORE TIME IN FORMAL PRESENTATION THAN DISCUSSION FOR THIS PARTICULAR TOPIC. THE BSA WAS SENT A COPY OF THE REPORT WHICH ADDRESSED THIS ISSUE. AND SO THIS IS ON THE MINDS OF MANY PEOPLE. ANY INTRODUCTORY COMMENTS FROM THE SUBCOMMITTEE BEFORE WE DIVE RIGHT IN TO IT. JEFF ABRAMS AND MEG MOONEY WILL GIVE AN OVERVIEW. >> THANK YOU. GOOD AFTERNOON. AT THE OUTSET DR. MOONEY AND I WANTED TO RECOGNIZE THE LEADERSHIP OF THE DOCTOR IN THIS EFFORT AS WELL AS MULTIPLE CONTRIBUTIONS OF COLLEAGUES IN DCDT AND DCP OVER THE PAST TWO YEARS. THERE ASSISTANCE WITH THAT OF MANY PEOPLE IN THE EXTRAMURAL COMMUNITY HAVE ALL CONTRIBUTE TO THIS IMPORTANT REORGANIZATION THAT WE WILL PRESENT TODAY. NOW BEFORE PROCEEDING TO THE MAJOR BUSINESS FOR TODAY I WANT JUST TO REMIND EVERYBODY A THAT A LOT OF ATTENTION IS FOCUSED ON THE COOPERATIVE GROUPS OF THE LATE THERE HAVE BEEN MANY IMPORTANT CHANGES DATING BACK TO THE WORKING GROUP FIRST BEGAN TO MEET AND CONSIDER THE TOPIC. JUST A FEW OF THESE ARE SHOWN ON THE SLIDE. THE SPEED AND EFFICIENCY OF DEVELOPING THE TRIALS AND THEN CONDUCTING THEM HAS BEEN A PRIORITY FOR US. WE ARE PROVIDING 24-7 CENTRAL REGISTRATION FOR ALL OUR COOPERATIVE GROUP TRIALS THAT NOW INCLUDES OUR PEDIATRIC TRIALS. THEY COLLECT IN THE CENTRAL LOCATION ALL THE REGULATORY DOCUMENTS. WE'VE ALSO HADVt– NCI CENTRAL IRB FOR PHASE THREE TRIALS FOR ADULTS ALL TRIALS IN THE PEDIATRIC ONCOLOGY GROUPS. WE'VE QUALIFIED OUR SITES FOR ADVANCED IMAGING SO THAT THIS DOESN'T HAVE TO BE DONE EVERY TIME IMPORTANT NEW IMAGING TRIAL IS LAUNCHED. WE'VE ALSO TRIED TO INCORPORATE INNOVATIVE SCIENCE AND NEW TRIAL DESIGN TECHNIQUE IN TO OUR TRIALS. OUR DIVISION OF CANCER TREATMENT AND DIAGNOSIS HAS INSTITUTED THE NEXT PROGRAM, THE EXPERIMENTAL THERAPEUTICS PROGRAM THERE IS MULTIPLE AGENTS UNDER DEVELOPMENT, EARLY DEVELOPMENT BOTH PRECLINICALLY AND CLINICALLY WITH EXTERNAL PEER REVIEW AND SINGLE PIPELINE NOW DETERMINES HOW THESE AGENTS COME IN TO THE NCI. MIRRORING THIS APPROACH FOR ASSAY DEVELOPMENT WHICH OBVIOUSLY BECOMES EXTREMELY IMPORTANT NOW, NOW THAT WE'RE PRACTICING PRECISION MEDICINE IS THE CLINICAL ASSAY DEVELOPMENT PROGRAM. THIS PROGRAM IS JUST GONE THROUGH ITS FIRST TWO REVIEW CYCLES AND HAVE BEEN INNOVATIVE NEW ASSAYS THAT HAVE COME FORWARD FOR DEVELOPMENT. TRYING TO BE INCLUSIVE AND FIND WAYS IN TO CLUED NON-GROUP INVESTIGATORS, NONCOOPERATIVE GROUP INVESTIGATORS WHO HAVE NOVEL UNDERSTANDS CAN BRING THESE IDEAS TO OUR DISEASE SPECIFIC STEERING COMMITTEES FOR FURTHER REFINEMENT AND DEVELOPMENT IN TO DEFINITIVE TRIALS. SO, NOW I'M GOING TO INTRODUCE DR. MEG MOONEY WHO IS THE CHIEF OF THE CLINICAL INVESTIGATION BRANCH AT NCI SERVES AS LEAD PROGRAM OFFICER FOR THIS REVISED COOPERATIVE GROUP SYSTEM TO TAKE US THROUGH THIS NEW RFA. >> THANK YOU. WE'RE VERY HAPPY TO BE HERE TODAY TO BE ABLE TO PRESENT THIS RFA FOR A NEW NCI CLINICAL TRIALS NETWORK TO THE BSA OUR PRESENTATION TODAY WILL ACTUALLY COVER THREE PARTS. THE FIRST PART WE'RE GOING TO PRESENT BRIEF OVERVIEW OF THE CURRENT SYSTEM, IT'S ACCOMPLISHMENTS AND BACKGROUND RATIONAL FOR NEW INTEGRATED NETWORK. SECOND PART WE'RE GOING TO CONCENTRATE TELL YOU A LITTLE BIT ABOUT THE PROGRESS THAT WE'VE ALREADY MADE TOWARDS INTEGRATED NETWORK AND THEN THE THIRD PART INDEPTH DESCRIPTION OF EACH OF THE MAJOR COMPONENTS OF THE NEW RFA INCLUDING THE REVIEW CRITERIA, BUDGET, TENT SIEVE TIMELINE FOR IMPLEMENTATION. OVER 50 YEARS THE NCI HAS PROVIDED STANDING INFRASTRUCTURE FOR CLINICAL TRIALS TO BE CONDUCTED, LARGE SCALE CLINICAL TRIALS IN BOTH TREATMENT, PREVENTION, SCREENING AND CANCER CONTROL ACROSS THE UNITED STATES AND NORTH AMERICA. THAT IS KNOWN AT NCI COOPERATIVE GROUP PROGRAM, IT HAS INVOLVED OVER 3100 INSTITUTIONS, 14,000 INVESTIGATORS AND ABOUT 25,000 PATIENTS ON TREATMENT TRIALS ANNUALLY. THE VAST MAJORITY OF THOSE PATIENTS OVER 83% ARE ENROLLED ON DEFINITIVE PHASE III TRIALS. A NOTABLE STRENGTH OF THE PROGRAM IS ITS BROAD BASED IN TERMS OF INVESTIGATORS AND PARTICIPANTS, THAT DOES INCLUDE NOT ONLY NCI CANCER CENTERS AND OTHER ACADEMIC CENTERS BUT ALSO COMMUNITY CLINICAL ONCOLOGY AND MINORITY-BASED CLINICAL ONCOLOGY CENTERS AND OTHER COMMUNITY CENTERS AND SEVERAL GROUPS ALSO HAVE KEY INTERNATIONAL MEMBERS. BECAUSE OF THAT BROAD REPRESENTATION AND TYPE OF SCIENCE THEY CONDUCTED OVER THE LAST 50 YEARS, THEY HAVE BEEN RESPONSIBLE FOR MANY NOTABLE ADVANCES IN TREATMENTS, BUT ALSO IN CLINICAL CARE RELATED TO SYMPTOM MANAGEMENT, CANCER CONTROL, SCREENING AND PREVENTION. CENTRAL QUESTION HOWEVER GOING FORWARD IS WHETHER TO CONTINUE THE SUPPORT, ITS STANDING INFRASTRUCTURE FOR PUBLICLY FUNDED CLINICAL TRIAL SYSTEM. THAT ACTUALLY BEEN ALTERNATE THE HEART OF OUR PAST -- OVER THE PAST TWO YEARS OUR EXTENSIVE REVIEW OF THIS PROGRAM INCLUDING THE INSTITUTE OF MEDICINE REPORT. CANCER SCIENCE IS EVOLVING, IT IS EVOLVING IN TO A MORE MOLECULARLY DEFINED SCIENCE BECAUSE OF THAT, THERE ARE NOW GENETIC SUBCLASSIFICATIONS OF DISEASE, THERE IS NO FUNCTIONAL IMAGING THAT HAS HELPED IMPROVE DIAGNOSIS, WE ARE DEVELOPING NEW TREATMENTS THAT ARE TARGETED TOWARDS SPECIFIC CANCER RELATED PATHWAYS. SO THE QUESTION IS, HOW THE PUBLIC, CLINICAL TRIAL SYSTEM WILL ADJUST THESE NEW OPPORTUNITIES WHETHER IT HAS ROLE TO PLAY. FROM THE CONSENSUS OF ALL THE REVIEWS INCLUDING THE INSTITUTE OF MEDICINE THE THERE REALLY WAS A STRONG CONSENSUS THAT IT DOES FULFILL A CRITICAL NEED THAT IS NOT ADDRESSED BY THE PRIVATE SECTOR INDUSTRY. PARTICULARLY THE PUBLIC SYSTEM FOCUSES ON RESEARCH QUESTIONS THAT ARE NOT PRIORITIES NECESSARILY FOR INDUSTRY. SOME OF WHICH ARE LISTED HERE. INTEGRATION OF NEW AGENTS IN TO STANDARD REGIMEN, COMBINATION OF NOVEL AGENTS FROM VARIETY OF SPONSORS, A FOCUS ON MULTI-MODALITY THERAPY INCLUDING SURGERY AND RADIATION AND I.T. THERAPY. THERAPY FOR RARE CANCERS INCLUDING PEDIATRIC CANCERS. SCREENING, DIAGNOSIS AND PREVENTION. ALSO LOOKING AT OPTIMAL DURATION AND DOSE OF DRUGS AND OTHER MODALITIES LIKE RADIO THERAPY AND LASTLY, LOOKING AT CLINICAL TREATMENTS THAT ALREADY AVAILABLE COMMERCIALLY, BUT ARE COMPETING AND TO TRY TO EVALUATE THEM HEAD TO HEAD. IN ADDITION THE TRIALS ARE ORIENTED TOWARDS DISEASE MANAGEMENT. THEY'RE NOT NECESSARILY AGENT SPECIFIC OR LIMITED BY MARKETING CONSTRAINTS. ALLOWS US TO DO IMPORTANT RESEARCH QUESTIONS IN AN ANCILLARY MATTER RELATED TO CORRELATIVE SCIENCE, IMAGING, QUALITY OF LIFE, SYMPTOM MANAGEMENT AND SPECIAL POPULATION. VERY IMPORTANTLY THERE IS ALSO EXTENSIVE DIRECT INVOLVEMENT OF THE ENTIRE ONCOLOGY COMMUNITY IN THE DESIGN OF THESE TRIALS AND IN THEIR CONDUCT. SO THAT INCLUDES ACADEMIC INSTITUTIONS AND INVESTIGATORS BUT ALSO THE COMMUNITY INCLUDING PRIVATE PRACTITIONERS, PATIENT ADVOCATES, YOUNG INVESTIGATORS IN TRAINING AND INTERNATIONAL COLLABORATORS. ALSO NOTED BY THE IOM ALL THE REVIEWS THAT DATA SHARING ARE BOTH CLINICAL DATA AND THE SPECIMENS WITH ANNOTATED CLINICAL DATA FROM THESE LARGE DEFINITIVE TRIALS IS INVALUABLE RESOURCE FOR ENTIRE COMMUNITY. HAS LED TO ADDITIONAL NEW DISCOVERIES AND OPPORTUNITIES. LOOKING OVER THE MAJOR ACCOMPLISHMENTS OF THE PROGRAM FROM 2005 TO 2011, THERE HAVE BEEN OVER 30 PRACTICE CHANGING TRIALS INCLUDING THERAPEUTIC AGENTS AND OTHER MODALITIES FROM THE COOPERATIVE GROUP SYSTEM AND IN FACT FOUR OF THOSE MAJOR PRACTICE CHANGING RESULTS HAVE OCCURRED IN THE FIRST SIX MONTHS OF TWELVE. THOSE FOUR -- 2011. THEY ARE LISTED HERE. I THINK THEY ESPECIALLY ILLUSTRATE HOW THE PUBLIC SYSTEM ADDRESSES QUESTIONS THAT WOULD NOT BE ADDRESSED BY THE PRIVATE SECTOR. THE FIRST TWO INVOLVE SURGERY AND RADIO THERAPY AND IMPORTANT ADVANCES IN BREAST CANCER, THIRD INVOLVES THOUSAND OF GENERIC AGENT ATTIC DOSE, HIGH DOSE METRICS EIGHT IN ARRAY OF PEDIATRIC CANCER. YOU YOU IN ADDITION OVER THE SAME TIME PERIOD THERE HAVE BEEN HOVER TEN FDA NEW INDICATIONS FOR ONCOLOGY AGENTS THAT WERE SPEARHEADED BY THE COOPERATIVE GROUP TRIALS. THEY ARE LISTED HERE. INCLUDED IN THAT LIST IS ACTUALLY THE PRIMARY FDA INDICATION FOR -- IN BOTH PEDIATRIC AND ADULT PATIENT POPULATIONS IN RARE T CELL LYMPHOMA. WHICH GENERIC AGENTS TWO OF THOSE ARE LISTED AT THE BOTTOM AS EXAMPLES. HIGH DOSE WITH STANDARD CARE. BOTH OF THOSE LED TO IMPROVEMENTS IN OVERALL SURVIVAL. WE'VE HAD NUMBER OF REPORTS ABOUT THE SYSTEM AND THE STATUS OF THE SYSTEM AND HOW BEST TO TRANSFORM IT TO MEET THE CHALLENGES OF THE FUTURE. THAT INCLUDED THE CLINICAL TRIALS WORKING GROUP REPORT IN 2005 FOLLOWED BY OPERATIONAL EFFICIENCY WORKING GROUP. WE'VE ALSO HAD RECOMMENDATIONS AND MOST NOTABLY THE INSTITUTE OF MEDICINE REPORT WHICH WAS RELEASED IN APRIL OF 2010. OVER THE LAST 18 MONTHS WE'VE HAD AN EXTENSIVE REVIEW INTERNALLY BUT ALSO VERY PUBLIC DIALOGUE WITH ALL THE STAKEHOLDERS INVOLVED IN THE SYSTEM, ALL OF WHOM ARE LISTED AROUND THE CIRCLE THERE. AND IN ADDITION TO GETTING INPUT FROM EACH OF THOSE STAKEHOLDER GROUPS WE HAVE HAD PROFESSIONAL OPERATIONAL ANALYSIS OF THE SYSTEM FROM THE SCIENCE AND TECHNOLOGY POLICY INSTITUTE AND WE'VE ALSO SOUGHT GENERAL PUBLIC INPUT ON ONGOING BASIS THROUGH NCI PUBLIC WEBSITE AND MAILBOX. ALL OF THIS LED TOWARDS CONSENSUS GOALS FOR TRANSFORMED SYSTEM. THE INSTITUTE OF MEDICINE ACTUALLY LAID OUT FOUR CENTRAL GOALS THAT THEY FELT NEEDED TO BE ADDRESSED IN ANY NEW CLINICAL TRIAL SYSTEM GOING FORWARD. THOSE ARE LISTED HERE IN RED. OVER THE PAST 18 MONTHS WE'VE ACTUALLY WORKED WITH THE COMMUNITY TO ADDRESS MANY OF THESE AREAS. SO UNDER SPEED AND EFFICIENCY AND DEVELOPMENT OF TRIALS, AS JEFFREY LATE WE'VE HAD IMPLEMENTATION OF OPERATIONAL EFFICIENCY GUIDELINES AND TIMELINES. WE'RE ALSO OVER NEXT 18 MONTHS ROLLING OUT IMPLEMENTATION OF A COMMON DATA MANAGEMENT SYSTEM. IN TERMS OF INNOVATIVE SCIENCE AND TRIAL DESIGN WE IMPLEMENTED A NEW PROGRAM TO ALLOW US TO PUT ESSENTIAL INTEGRATED AND INTEGRAL STUDIES INCLUDING BIOMARKERS, IMAGING AND QUALITY OF LIFE IN TO THESE LARGE SCALE DEFINITIVE TRIALS. WE'VE ALSO ENCOURAGED RANDOMIZED PHASE II TRIALS TO BETTER ASSESS WHAT SHOULD GO FORWARD. WE'VE IMPLEMENTED DISEASE SPECIFIC AND SPECIALTY SPECIFIC STEERING COMMITTEES, THESE ARE COMMITTEES THAT HAVE REPRESENTATIVE FROM THE ENTIRE COMMUNITY INCLUDING CANCER CENTERS AS WELL AS COOPERATIVE GROUPS AND OTHER TRANSLATION FALL INVESTIGATORS AND PATIENT ADVOCATES TO HELP US PRIORITIZE THE TRIAL SO IT SHOULD ACTUALLY BE CONDUCTED THROUGH THE PROGRAM. WE HAVE ALSO IMPLEMENTED SLOWLY OCCURRING GUIDELINES TO IDENTIFY EARLY TRIALS THAT ARE NOT ACCRUING WELL AND EITHER MAKE THE APPROPRIATE MODIFICATIONS SO THEY SUCCESSFULLY ACCRUE OR ACTUALLY STOP THEM EARLY IF IN FACT THEY PROVE NOT TO BE FEASIBLE. UNDER INSURING PARTICIPATION OF PATIENTS AND PHYSICIANS IN THE SYSTEM WE'VE HAD SOME PILOT INITIATIVES FOR INCREASING REIMBURSEMENT FOR COMPLEX PHASE TWO AND PHASE THREE TRIALS. WE'VE ALSO INSTITUTED INITIATIVES TO ASSESS GET EARLY FEEDBACK FROM PHYSICIANS AND PATIENTS TO ENHANCE ACCRUAL AND I'LL GO IN TO SOME OF THOSE IN A MINUTE. WE HAVE HAD SOME PROGRESS BUT WE ACTUALLY RECORD IN TERMS OF HOW WE'RE DOING IMPLEMENTATION OF SOME OF THOSE OBJECTIVES. IN PARTICULAR OPERATIONAL EFFICIENCY YOU CAN SEE IN BLUE HERE HISTORIC MEDIAN DAYS THAT IT TOOK US TO ACTUALLY SUBMIT REVIEW AND ACTIVATE A CLINICAL TRIAL. PROMOTE PHASE III AND EARLY FADES DRUG DEVELOPMENT TRIALS. WE INSTITUTED NEW TIMELINES AND AGGRESSIVE TARGETS THOSE ARE THE COLUMNS IN RED FOR EACH PHASE OF TRIAL. OUR AIM WAS TO TRY TO REDUCE THOSE HISTORICAL TIMELINES BY ABOUT 60%. WE ALSO INSTITUTED ABSOLUTE DEADLINES SO THAT PHASE III TRIALS THAT DO NOT ACTIVATE WITHIN TWO YEARS AND PHASE 2 TRIALS THAT DO NOT ACTIVATE WITHIN 18 MONTHS DO NOT GO FORWARD. LOOKING OVER OUR FIRST 20 MONTHS, IN TO THIS PROGRAM OF INSTITUTING THESE GUIDELINES WE HAVE BEEN ABLE TO REDUCE OUR GUIDELINES VERSUS HISTORICAL -- TIMELINES, VERSUS HISTORICAL LEVEL BY ABOUT 50%. SO WE'RE NOT QUITE YET AT THE EXACT RED TARGETS THAT WE'D LIKE TO BE AT. WE STILL HAVE A LOT OF WORK TO DO BUT WE HAVE MADE A DRAMATIC IMPROVEMENT ALREADY BY WORKING DIRECTLY AND COLLABORATIVELY WITH THE EXTRAMURAL COMMUNITY TO BRING THESE TIMELINES DOWN BY 50%. WE ALSO ESTABLISHED A BIOMARKER IMAGING AND QUALITY OF LIFE FUNDING PROGRAM THAT WOULD ALLOW US TO VERY RAPIDLY ASSESS PROPOSALS TO PUT INTEGRAL AND INTEGRATED BIOMARKERS AS WELL AS IMAGING SCIENCE AND QUALITY OF LIFE IN TO DEFINITIVE TRIALS OVER THE PAST THREE AND A HALF YEARS, 13 PHASE THREE TRIALS HAVE RECEIVED SUPPORT UNDER THIS PROGRAM TOTALING OVER $22 MILLION. YOU SEE THREE EXAMPLES LISTED BELOW IN PEDIATRIC AML, ESOPHAGEAL CANCER AND BREAST CANCER. AB THE RIGHT HAND SIDE YOU SEE THE FUNDING HAS BEEN SPLIT ABOUT 80% OF IT HAS GONE FROM BIOMARKERS, 12% FOR QUALITY OF LIFE AND% FOR IMAGING. WE'VE ALSO INSTITUTED DISEASE SPECIFIC STEERING COMMITTEES TO HELP US PRY OTHER SIZE THE TRIALS THAT GO FORWARD, LARGE PHASE TWO TRIALS AND ALL PHASE THREE TRIALS. WE STARTED IN 2006 WITH THE STEERING COMMITTEE NOW HAVE STEERING COMMIT THESE COVERING ALMOST THE ENTIRE SPECTRUM OF RESEARCH THAT WE DO IN THE VARIOUS DISEASES. SINCE 2006 OVER 170 CONCEPTS HAVE BEEN 'EUWAITED BY STARING COMMITTEES YOU SEE BROAD RANGE OF INVESTIGATORS WHO ARE COCHAIRS OF THIS COMMITTEE INCLUDING SEVERAL CANCER CENTER DIRECTORS. WE'VE ALSO HAD STEERING COMMITTEES ESTABLISH IN SPECIALTY AREAS WITH THE NON-DISEASE FOCUS TO HELP US MAKE SURE THAT WE PRIORITIZE THESE ASPECTS IN CLINICAL TRIALS. WE HAVE INVESTIGATIONAL DRUG STEERING COMMITTEE, A CLINICAL IMAGING COMMITTEE, ONE IN SYSTEM MANAGEMENT, HEALTH RELATED QUALITY OF LIFE AND ALSO PATIENT ADVOCATE STEERING COMMITTEE YOU SEE COCHAIRS LISTED HERE. BUT THE PROGRESS THAT WE'VE MADE IN FRYING TO INTEGRATE THE NETWORK ADDRESS MANY OF THOSE CONSENSUS GOALS, THE STRUCTURE OF THE PROGRAM AT THE BEGINNING OF 2011 WAS PRETTY MUCH THE WAY IT HAD BEEN FOR THE PAST SEVERAL DECADES. WE HAD TEN U.S. GROUPS THAT WERE ALL ORGANIZED SEPARATELY FROM ONE ANOTHER. THEY HAD THEIR OWN OPERATIONS THEY WERE ALL REVIEWED SEPARATELY UNDER THE PROGRAM AT DIFFERENT TIME POINTS AND TO SOME EXTENT BY DIFFERENT REVIEWERS. THOUGH WE'VE TRIED TO CENTRALIZE MANY OF THE ADMINISTRATIVE AND REGULATORY FUNCTION OF THE ENTIRE NETWORK, AN EXAMPLE OF THAT IS ESTABLISHMENT OF THE NCI CANCER TRIAL SUPPORT UNIT OR CTSU THAT JEFF MENTIONED WHERE WE HAVE CENTRALIZED PATIENT ENROLLMENT AND COLLECTION OF ALL THE REGULATORY DOCUMENTS. WE ALSO HAVE THE CENTRAL IRBs AND WE'VE NOW HAD DISEASE STEERING COMMITTEES. WE STILL WERE OPERATING ORGANIZED -- AS YOU SEE HERE HAD VERY SILOD AFFECT, DESPITE THE FACT WE TRIED TO ENCOURAGE CROSS GROUP ACCRUAL IT WAS STILL VERY DIFFICULT TO INTEGRATE WHEN EVERYTHING WAS ORGANIZED IN THIS MANNER. GOING FORWARD WE BELIEVE THIS NEW RFA ALLOWS US TO TAKE THE NEXT STEP IN TRANSFORMING THE SYSTEM AND TO MAKE TRULY INTEGRATED NATIONAL CLINICAL TRIAL NETWORK, THE NCI IS RECOMMENDING THAT WE CONSOLIDATE THE GROUP AND PROVIDE FUNDING FOR ONE PEDIATRIC GROUP AND UP TO FOUR ADULT GROUPS. WE ARE ALSO RECOMMENDING THAT WE FUNDAMENTALLY CHANGE THE REVIEW CRITERIA SO THAT THERE IS AN EMPHASIS ON INTEGRATION AND COLLABORATION. THE EMPHASIS BE ON OVERALL SCIENTIFIC ACHIEVEMENT AND OPERATIONAL EFFICIENCY. WE'RE ALSO RECOMMENDING THAT WE HAVE A FUNDING MODEL THAT DOES PROVIDE INCREASE FOR CASE REIMBURSE TOMORROW SITES THAT ARE HIGH PERFORMERS AND THAT HAVE A LARGE FOLLOW UP BURDEN BECAUSE OF THE NUMBER OF PATIENTS THEY ACCRUE. ALSO RECOMMENDING COMPETITIVE INTEGRATED TRANSLATION FALL SCIENCE AWARDS SO THAT WE CAN ALLOW TRANSLATION FALL SCIENCE TO BE INTEGRATED IN TO THESE DEFINITIVE TRIALS AND LASTLY, WE WANT TO REVITALIZE THE CANCER CENTER ROLE IN PARTICIPATING IN NETWORK TRIALS. THIS IS REALLY AN ILLUSTRATION OF THE OVERALL NEW RFA, ALL THE BOXES HIGHLIGHTED IN DARK BLUE ARE ACTUALLY THE COMPONENTS OF THE SYSTEM THAT ARE FUNDED UNDER THE RFA THAT WE ARE PRESENTING TODAY. HOWEVER, THIS RFA ALL ITS COMPONENTS ARE REALLY PART OF A MUCH BIGGER NETWORK. THE DARK BLUE AGAIN AS I STATED IS -- FOR EVERYTHING UNDER THIS RFA WE'LL GO OVER THAT IN A LITTLE MORE DETAIL IN A FEW MINUTES. BUT ALSO WANT TO POINT OUT THAT THIS RFA IS INTEGRATED WITH OTHER NCI PROGRAMS, PARTICULARLY WE DO HAVE OTHER NCI GRANT PROGRAMS THAT ARE INTEGRATED NICELY IN THE SYSTEM BECAUSE WE WORK CLOSELY WITH THE DIVISION OF CANCER PREVENTION. THEY FUND THE COMMUNITY CLINICAL ONCOLOGY AND MINORITY-BASED CLINICAL ONCOLOGY PROGRAMS THAT PARTICIPATE IN THE TREATMENT TRIALS UNDER THIS RF ACTION ALSO WORK WITH THE NCI CANCER DIAGNOSIS PROGRAM THAT PROVIDES THE EXPERTISE AND INFRASTRUCTURE SUPPORT FOR -- THE TEAMS ASSOCIATED WITH THE COOPERATIVE GROUP. IN ADDITION WE DO HAVE CONTRACT PROGRAMS THAT CENTRALIZE ADMINISTRATIVE SUPPORT AS PREVIOUSLY MENTIONED. THE NCI CENTRAL AND CANCER TRIAL SUPPORT UNIT. LASTLY, WE ALSO HAVE IMPORTANT EXTRAMURAL AND ADVISORY COMMITTEES. WE ALREADY TALKED ABOUT DISEASE SPECIFIC STEERING COMMITTEES BUT HAVE NCI ADVISORY COMMITTEE THAT ALSO HAS SUBCOMMITTEE THAT PROVIDES STRATEGIC PLANNING AND OVERSIGHT FOR THE ENTIRE NETWORK. THE BIG QUESTION IS, HOW WILL THIS CONSOLIDATED NETWORK HELP, HOW DO WE SEE IT HELPING WHAT IS THE RATIONAL FOR THAT. WE REALLY DO BELIEVE THAT ESSENTIALLY A SMALLER NUMBER OF INTEGRATED GROUPS AND TRULY INTEGRATED NETWORK WILL ALLOW US TO CONSOLIDATE INFRASTRUCTURE TO GAIN EFFICIENCY, PARTICULARLY IN I.T., REGULATORY, ADMINISTRATIVE ISSUES AND ON TISSUE RESOURCE MANAGEMENT. WE ALSO BELIEVE THAT CONSOLIDATING IMAGING AND RADIO THERAPY CORE SERVICES IN TO ONE CENTRAL ORGANIZATION THAT BENEFITS THE ENTIRE NETWORK WILL BE OF TREMENDOUS BENEFIT. WE ALSO WANT TO MAKE SURE THAT WE INTEGRATE NEW COMPONENTS IN TO TRIALS TO PROVIDE VALUE-ADDED RESEARCH QUESTIONS, PARTICULARLY IN ADVANCED IMAGING AND TRANSLATION FALL SCIENCE. BOTTOM LINE DESPITE DOING ALL THAT WHAT DO WE REALLY SEE THE BENEFIT BEING? WE DO THINK THAT A SMALLER NUMBER OF COOPERATIVE GROUP OR NETWORK GROUP ORGANIZATIONS THAT ARE FULLY INTEGRATED WILL ACTUALLY HELP US INTEGRATE NEW AGENTS MUCH MORE RAPIDLY IN TO TRIALS. AN EXAMPLE IS THAT TRIALS ARE ALREADY BEING DEVELOPED WITH -- IN EARLIER STAGES OF LUNG CANCER AND MELANOMA, FOR EXAMPLE. BUT THEY REQUIRE SCREENING OF LARGE POPULATIONS. AND HAVING AN ENTIRE NETWORK OF ALL THE GROUPS WORKING TOGETHER WILL ALLOW US TO ADDRESS THOSE RESEARCH QUESTIONS MUCH MORE RAPIDLY ALSO BE ABLE TO EVALUATE COMBINING THOSE AGENTS OPTIMALLY WITH SURGERY, RADIO THERAPY AND IMMUNOTHERAPY. WE ALSO THINK LARGE INTEGRATED NETWORK WILL HELP US EYE VALUE WAIT NEW AGENTS MOLECULARLY DEFINE DISEASE SUBSETS EVEN FOR COMMON DISEASES SUCH AS BREAST CANCER. THE NUMBER OF PATIENT SUBSETS IS INCREASING THERE'S NEED FOR TRIAL PRIORITIZATION, HOW TO EVALUATE MULTIPLE NEW AGENTS AND WE THINK THAT INTEGRATED CLINICAL TRIAL SYSTEM AS WE'RE PROPOSING UPPED THIS RFA WILL BE VERY WELL POSITIONED TO DO THAT. THIS IS THE NETWORK THAT WE ARE PROPOSING. I WILL BE GOING BRIEFLY IN TO EACH OF THE MAJOR COMPONENTS BUT FIRST BEING THE GROUP, BOTH PEDIATRIC AND ADULT GROUPS WHICH WILL BE ORGANIZED TO WORK TOGETHER IN A NETWORK SYSTEM. ALSO TALKING ABOUT NETWORK LEAD ACADEMIC PARTICIPATING SITES PROVIDING GRANT SUPPORT FOR THOSE HIGH PERFORMING SITES THAT CONTRIBUTE THE MOST SCIENTIFICALLY AS WELL AS IN TERMS OF ACCRUAL TO THE ENTIRE NETWORK. THEN BE DISCUSSING ANOTHER COMPONENT OF THE RFA WHICH IS PROVIDING NETWORK INTEGRATED TRANSLATION FALL SCIENCE AWARD. LASTLY, WE'LL BE DISCUSSING HAVING A CORE FOR THE ENTIRE NETWORK BOTH IMAGING AND RADIO THERAPY SERVICES AND ALSO COLLABORATION WITH CANADIAN CLINICAL TRIALS NETWORK. SO, IN TERMS OF THE FIRST COMPONENT WHICH ARE THE GROUP OPERATIONS AND GROUP STATISTICAL CENTERS, THESE ARE OBVIOUSLY OF THE HEART OF THE OPERATION, IS THAT COME UP WITH IDEAS, PROMOS THEM, REFINE THEM CONDUCT THE CLINICAL TRIALS. THEY PROVIDE OVERALL STRATEGIC STRATEGY AND GOALS ACROSS A BROAD RANGE OF DISEASES. THERE ARE ALSO RESPONSIBLE OBVIOUSLY IN ADDITION TO STUDY CONCEPTION AND PROTOCOL DEVELOPMENT TO ADHERENCE TO OPERATIONAL EFFICIENCY TIMELINES, AUDITS, QC AND QA. COLLECTING THE BIOSPECIMENS FROM PATIENTS ON TRIAL AND COMPLIANCE WITH ALL REGULATORY REGULATIONS. THEY ALSO PROVIDE OBVIOUSLY STATISTICAL LEADERSHIP FOR EFFECTIVE DESIGN OF THE TRIAL AND TRIAL CONDUCT THAT THEY MONITOR ON ONGOING BASIS BOTH DATA QUALITY FOR PRIMARY AS WELL AS SECONDARY ENDPOINT. LASTLY, AS PART OF THE NEW RFA WE ALSO WILL BE PROVIDING DATA MANAGEMENT SUPPORT FOR MANAGEMENT OF THE DATA AS WELL AS ANALYSES FOR STUDIES THAT COME FROM OUTSIDE THE NETWORK. FROM INVESTIGATORS WHO MAY NOT BE PART OF ANY OF THE PARTICULAR GROUPS IF IN FACT KNEES STUDIES ARE PRIORITIZED FOR CONDUCT BY APPROPRIATE SPHERING COMMITTEE. IN ORDER TO ACHIEVE WHAT WE BELIEVE IS NECESSARY WHICH IS INTEGRATED NETWORK WE FEEL THAT WE HAVE TO FUNDAMENTALLY CHANGE THE WAY WE DO NCI AND NIH EXTERNAL PEER REVIEW OF THE PROGRAM. IN PARTICULAR WE'RE FOCUSING THE INCENTIVE OF THE REVIEW PROCESS ON INCENTIVES FOR A NATIONAL SYSTEM TOE THAT TRIALS WILL BE OPEN TO ALL QUALIFIED SITES THAT ARE MEMBERS OF ANY OF THE NETWORK GROUPS AND THAT ANY OF THE SITES CAN CREDIT ANY GROUP TO WHICH THEY BELONG. ALSO FOR THE FIRST TIME BE REVIEWING ALL THE NETWORK GROUPS AND THEIR COMPONENTS AT THE SAME TIME. BY LOOKING AT THEM INDIVIDUALLY AT DIFFERENT POINTS IN TIME VERY DIFFICULT FOR THE REVIEWERS TO GET A SENSE OF THE ENTIRE NETWORK AND TO ACTUALLY PROVIDE THE BEST REVIEW AND ADVICE IN TERMS OF HOW TO GO FORWARD. SHIFT TO EVALUATING THE GROUP'S ROLE IN NATIONAL SYSTEM AND OVERALL STRATEGY AND INNOVATION AND QUALITY OF ITS TRIALS. RATHER THAN FOCUSING ON VERY ROUTINE REVIEW OF EACH INDIVIDUAL COMMITTEE WITHIN A EXWRUP. IN THE NEXT LARGE COMPONENT WE HAVE COMPONENT THAT ADDRESSES PROVIDING U10 GRANTS FOR LEAD ACADEMIC PARTICIPATING SITES. THESE WILL BE MULTIPLE P.I. GRANTS WHICH HAVEZ@h DEMONSTRATED THEY WOULD BE CONSIDERED HIGH PERFORMANCE SITES. THEY WILL BE TARGETED THE NCI COMPREHENSIVE CLINICAL CANCER CENTERS OTHER LEADING ACADEMIC CENTERS. REVIEW CRITERIA WILL BE DIFFERENT THAN THEY HAVE BEEN IN THE PAST. IN THE PAST U10 GRANTS FOR LARGE INSTITUTIONS LIKE THIS GIVING BOTH HIGH ACCRUAL AND SCIENTIFIC LEADERSHIP WERE DONE WITH THE RELATIONSHIP WITH JUST ONE GROUP AND ACCRUAL ASSOCIATED WITH THAT ONE GROUP INSTEAD THESE WILL BE INSTITUTIONS THAT PARTICIPATE IN TRIALS ACROSS THE NETWORK. TRANSLATION FALL SCIENCE AWARDS THESE WILL BE MULTIPLE PI GRANTS AS WELL BUT SUPPORT PROMINENT RESEARCHERS FOR EXPERTISE IN THEIR EFFORTS IN INCORPORATING MOLECULAR STUDIES IN TO NETWORK TRIALS AND ENABLING ACQUISITION OF PRELIMINARY DATA FOR FURTHER RESEARCH. FUNDING HERE TO HELP LABORATORY-BASED RESEARCHERS FACILITATE HAND OFF OF EARLY PHASE CLINICAL TRIAL FINDINGS IN TO LATER PHASE DEFINITIVE TRIAL. IN PARTICULAR REVIEW CRITERIA WILL FOCUS ON PEER REVIEW OF THE QUALITY OF THE SCIENTIFIC APPROACH AND PLANS FOR INTEGRATING THAT TRANSLATION FALL SCIENCE IN TO CLINICAL TRIALS. THE FOURTH AREA IS ON CORE SERVICES. AND PARTICULARLY RADIO THERAPY AND IMAGING BECAUSE THESE ARE TWO AREAS THAT HAVE VERY LIMITED SUPPORT IN TERMS OF THE PRIVATE SECTOR. AND INDUSTRY. WE BELIEVE THAT HAVING HA CONSOLIDATED CLEAR IN THESE TWO AREAS TO PROVIDE SCIENTIFIC LEADERSHIP FOR INCORPORATING APPROPRIATE QA AND IMAGE DATA MANAGEMENT FOR RESEARCH TRIALS INVOLVING THOSE AREAS IS ESSENTIAL. THE REVIEW CRITERIA WILL BE BASED OBVIOUSLY ON SCIENTIFIC LEADERSHIP AND EXPERTISE OF THE NETWORK WIDE RESOURCE. THAT WILL INVOLVE INTEGRATED I.T. PLATFORMS FOR CAPTURING AND STORING IMAGES AND DATA AS WELL AS EFFICIENT PROCEDURES FOR ACCESSING THAT DATA. AND CANADIAN SITES AND NONPROFIT CANADIAN CLINICAL TRIAL ORGANIZATIONS. REVIEW CRITERIA HERE WILL BE BASED SPECIFICALLY ON THE ABILITY OF SUCH A NETWORK TO PROVIDE APPROPRIATE REGULATORY OVERSIGHT FOR U.S. NETWORK TRIALS CONDUCTED IN CANADA IRRESPECTIVE OF WHICH GROUP LEADS THE TRIAL. TO BE FULL PARTNERS IN ACCRUING PATIENTS TO U.S. NETWORK TRIALS. THE MECHANISM AND FREQUENCY OF NEW APPLICATIONS. BUT THEY WILL COVER FIRST THE OPERATION AND STATISTICAL CENTERS AS WELL AS CANADIAN COLLABORATING NETWORK. THE SECOND RFA WILL BE FOR THE INTEGRATED TRANSLATION FALL SCIENCE AWARDS, THERE WILL BE SEPARATE -- EXCUSE ME SEPARATE FUNDING OPPORTUNITY ANNOUNCEMENT FOR THE RT AND IMAGING CORE SERVICES LASTLY A SEPARATE FUNDING OPPORTUNITY ANNOUNCEMENT FOR LEAD ACADEMIC PARTICIPATING SITES. THERE IS ALSO ONE LAST BUT CRITICAL FEATURE THAT WAS ACTUALLY SUPPORTED AND BROUGHT FORWARD BY ALL THE REVIEWERS AND STAKEHOLDERS HAD VERY PROMINENT PLACE AS WELL IN THE INSTITUTE OF MEDICINE ROORT. AND THAT IS THAT THE NCI NEEDED TO PROVIDE INCREASED RESEARCH REIMBURSEMENT TO ENSURE CONDITIONED PARTICIPATION OF SITES IN THE PUBLIC PROGRAM. OUR BASE FOR PATIENT ENROLLMENT IS FIXED AT -- OVER THE PAST DECADE. A 2006 ESTIMATE FOR WHAT IT ACTUALLY COSTS TO PUTT PER PATIENT COST AND INDUSTRY TRIALS WAS ABOUT 4700 DOLLARS FOR PHASE THREE TRIALS. SOME INDUSTRY TRIALS PROVIDE SUPPORT IN EXCESS OF $15,000 PER PATIENT. SURVEY IN 2009 OF GROUP SITES FOUND THAT THOSE PLANNING TO LIMIT PARTICIPATION IN THE PROGRAM, 75% OF THEM CITED INADEQUATE REIMBURSEMENT FOR THE DECLINE IN THE LEVEL OF THEIR PARTICIPATION. HAVE LARGEST BURDEN OF FOLLOW UP BECAUSE OF THE NUMBER OF PATIENTS THEY ACCRUED, THAT ADDITIONAL FUNDING IS ESSENTIAL TO COMPENSATE THEM FOR THIS. WE ARE PROPOSING THE BUDGET WHICH I'LL GO IN TO IN JUST A MINUTE ADDITIONAL $2,000 PER PATIENT FOR THOSE HIGH PERFORMING SITES WE HOPE TO PROVIDE, TO DOUBLE THE PER CASE REIMBURSEMENT. A VERY DIFFICULT TO READ SLIDE. THE CURRENT CLINICAL TRIALS SYSTEM THOSE BROKEN OUT BY VARIOUS COMPONENTS. MOST OF THE FUNDING OBVIOUSLY WENT TO THE GROUP OPERATIONS STATISTICAL CENTERS BUT THAT FUNDING ALSO INCLUDES MAJORITY OF PER CASE ACCRUAL THAT WAS GIVEN OUT TO THE SITE AS WELL. THE FUNDING HAS REMAINED ESSENTIALLY FLAT OVER THE MAST KNIFE TO SIX YEARS. WITH BUDGET CUT THAT HAD TO BE TAKEN AS WELL IN FISCAL YEAR 2011. BUT WITH THAT LEVEL FUNDING, WHAT THIS ACTUALLY MEANS AS YOU ALL KNOW IS THAT THERE ACTUALLY HAS BEEN SIGNIFICANT DECLINE IN PURCHASING POWER, YOU CAN SEE IN BLUE THE LEVEL FUNDING PROVIDED OVER LAST DECADE AND NCI OBLIGATIONS FOR THE COOPERATIVE GROUPS BUT IN RED REAL COST AND REAL PURCHASING POWER OF THAT FUNDING DEFLATED BY THE BIOMEDICAL RESEARCH AND DEVELOPMENT PRICE INDEX. THIS HAS LED US IN THE PROPOSALS IN TERMS OF THE BUDGET TO REQUEST ACTUALLY AN ADDITIONAL 25.6 MILLION DOLLARS FOR THE PROGRAM ABOVE THE CURRENT LEVEL. ON AN ANNUAL BASIS. AND THAT INCREASED FUNDING IS PRIMARILY TO GO TO THE SITE, IS THAT ARE PARTICIPATING PARTICULARLY HIGH PERFORMANCE SITES BOTH ACADEMIC CENTERS AND HIGH ACCRUING COMMUNITY CENTERS THAT PARTICIPATE IN THE PROGRAM. ABOUT 21 MILLION DOLLARS OF THAT WOULD GO TO THOSE SITES TO INCREASE REIMBURSEMENT. ADDITIONAL $4 MILLION WOULD GO TO SUPPLEMENT THE BIOMARKER IMAGING AND QUALITY OF LIFE PROGRAM THAT WE TALKED ABOUT BEFORE SO THAT WE CAN CONTINUE TO ENSURE THAT HIGH QUALITY TRANSLATION FALL AND INTEGRATED BIOMARKERS ARE INCLUDED IN THESE DEFINITIVE TRIALS. A NEW TOTAL OF $25.6 MILLION OVER THE CURRENT LEVEL. HOWEVER, IN ORDER TO ACTUALLY ACHIEVE THAT WE WOULD ALSO HAVE TO MAKE A REDUCTION IN TOTAL OF NUMBER OF PATIENTS WHO ARE ACCRUED SO WE ARE PROPOSING IN ADDITION TO THE INCREASED FUNDING TO REDUCE OUR ACCRUALS IN THE PROGRAM BY ABOUT 20%. ABOUT 20,000 AS OPPOSED TO 25,000. BY THESE THESE TWO THINGS OF WE WOULD BE ABLE TO PROVIDE ENOUGH ADDITIONAL REIMBURSEMENT TO CONTINUE TO HAVE PEOPLE ACROSS THE NATION IN THESE TRIALS. WE STATEMENT WITH THIS ADDITIONAL FUNDING AND ACCRUAL REDUCTION THAT WE WOULD BE ABLE TO PROVIDE INCREASE FUNDING FOR APPROXIMATELY 46% OF ALL THE ACCRUAL TO THE NETWORK ON AN ANNUAL BASIS. WE HAVE TREMENDOUS VOLUNTEER WORKFORCE THAT PARTICIPANTS IN THESE TRIALS. WE ACTUAL HIRED INDEPENDENT CONTRACTOR TO GIVE US AN ESTIMATED OF WHAT THE IN-KIND CONTRIBUTION WAS FROM ALL THE ACADEMIC CENTERS AND INVESTIGATORS AND COMMUNITY CENTERS WHO PARTICIPATE IN THE PROGRAM THAT ESTIMATE IS A LITTLE OVER $100 MILLION A YEAR. I THINK IT HIGHLIGHTS THE VERY NATURE OF WHAT IS COLLABORATIVE PARTNERSHIP IN THE GOVERNMENT AND EXTRAMURAL COMMUNITY TO MAKE SURE THAT THESE IMPORTANT TRIALS EXWET DONE. INCREASE IN FUNDING THAT WILL HAVE TO LOOK AT STRATEGIC PLANNING FOR THE NEW NETWORK. TREATMENT TRIAL ACCRUAL OVER PAST DECADE HAS REALLY BEEN DOMINATED BY LARGE ADJUVANT TRIALS CAN PARTICULARLY IN THE COMMON CANCERS LIKE BREAST AND GI BUT WITH THE NEW FUNDING MODEL REQUIRING THAT THE STEERING COMMITTEES MONITOR THE BALANCE OF TRIALS PRIORITIZED FOR DEVELOPMENT AND HELP US IN DEVELOPING STRATEGIC CONSENSUS ABOUT THE DISEASES IN WHICH TONE COURAGE MORE TRIALS AS SCIENTIFIC OPPORTUNITIES ARRIVE. WE HOPE THAT THE NEW REVIEW AND EXPECT THE NEW REVIEW CRITERIA WILL FACILITATE THIS AND FACILITATE MORE TRIALS AND KISS SEES AREAS WHICH HAVE BEEN TYPICALLY UNDER REPRESENTATIVE -- UNDER REPRESENTED, EXCUSE ME, RELATIVE TO THEIR INCIDENTS. AND THAT WE WILL ALSO HAVE HELP ON PORTFOLIO BALANCE WHICH WILL BE CLOSELY MONITORED BY STRATEGIC SUBCOMMITTEE WHICH WILL INCLUDE MEMBERS FROM NOT JUST GROUP ORGANIZATIONS AND FROM OTHER MEMBERS OF THE EXTRAMURAL COMMUNITY BUT ALSO THE CANCER CENTERS AS WELL TO HELP US PRIORITIZE AND TO ENSURE THAT SCIENTIFIC OPPORTUNITIES, PARTICULARLY IN LESS COMMON TUMORS ARE NOT MISS RD. WE DO HAVE A TENTATIVE TIMELINE FOR POTENTIAL IMPLEMENTATION. IT IS RATHER AGGRESSIVE AND LISTED HERE. WE'D HOPE IF WE CAN MOVE FORWARD FROM TODAY THAT WE WOULD BE ABLE TO HAVE NEW FUNDING OPPORTUNITIES AND GUIDELINES THAT WE'D BE ABLE TO REDUCE THE NEW FUNDING OPPORTUNITY ANNOUNCEMENTS PERHAPS IN THE MIDDLE OF THE SUMMER, JULY 2012 WITH RECEIPT OF APPLICATIONS IN THE WINTER OF 2012, REVIEW OF THOSE APPLICATIONS IN THE SUMMER OF 2013 AND THEN NCA REVIEW IN DECEMBER OR WINTER OF 2013 ROLL OUT OF NEW AWARDS IN FISCAL YEAR 2014 HOPEFULLY IN MARCH OF THAT YEAR. THIS IS THE OVERVIEW OF THE ENTIRE SYSTEM AND COMPONENTS UNDERMENT NEW RFA WE THANK YOU FOR YOUR ATTENTION, JEFF AND I WOULD BE HAPPY TO ANSWER ANY QUESTIONS YOU MAY THAT HAVE. DON'T WE TURN TOLT SUBCOMMITTEE. >> FIRST OF AWFUL REALLY CONGRATULATE JIM AND DR. MOONEY FOR THEIR RESPONSIVENESS TO THE SUBCOMMITTEE. WE PUT FORTH, THEY'RE ALL ANSWERED WONDERFULLY. I'LL JUST REALLY BRING UP FIVE POINTS AND THEN OPEN TO MY COLLEAGUES FOR FURTHER COMMENTS. BUT THINGS THAT WE WERE PARTICULARLY PLEASED TO SEE, EMPHASIS ON ACCRUAL FROM ALL GROUPS. REGARDLESS OF WHERE INSTITUTION ASSIGNMENT U10 GRANTS ARE INDIVIDUAL INSTITUTIONS THEN ADDRESSING CONCERNS THAT WERE -- THOSE ARE SPECIALTY RESEARCH IMAGING RADIOLOGY AND RADIATION ONCOLOGY THAT THESE WOULDN'T SOMEHOW IN THE REORGANIZATION BE LOST, THAT'S BEEN ADDRESSED. FINALLY THE INCENTIVE TO IMPROVE INTER-ACTION, COMPREHENSIVE, HERE ARE SOME OF THE BIG ISSUES THAT WE BROUGHT FORTH DISCUSSED IN CONFERENCE WITH THE NCI GROUP I FEEL CAME TO VERY GOOD RESOLUTION SO I'M VERY PLEASED AND I BELIEVE THIS IS A HUGE SIGNIFICANT STEP FORWARD AND REORGANIZING TO MEETS THE NEEDS. >> OPEN UP TO OTHER -- >> I THINK AGAIN I WOULD AGREE WITH WHAT MIKE HAS JUST SAID THIS IS MEAGAN AND JEFF AND COLLEAGUES THAT WILL BE CONGRATULATED FOR PUTTING TOGETHER I THINK A VERY RESPONSIVE DOCUMENT BOTH TO NCI'S CONCERNS AS WELL AS ALL THE STAKEHOLDERS. I WOULD INCLUDE THE CANCER CENTERS ALSO AS STAKEHOLDERS, AS MANY OF YOU KNOW THE CANCER CENTER COMMUNITY IS ALSO HAD LOT OF CONCERNS ABOUT COOPERATIVE GROUPS. I THINK THIS PARTICULAR RFA WAS VERY RESPONSIVE TO THE CONCERNS OF THE -- OF EACH OF THE GROUPS INCLUDING THE CANCER CENTER DIRECTORS AS WELL. IN CONTRAST TO MANY APPLICATIONS THAT ARE REVIEWED WITHIN -- BY NCI THIS IMPORTANT MECHANISM REALLY NEEDED TO BE REVIEWED AT THE SAME TIME. I THINK THAT IS A VERY, VERY IMPORTANT ASPECT OF REALLY ASSURING THAT THE SAME QUALITY IS LOOKED FOR IN EACH OF THE APPLICATIONS. THE OTHER ASPECT THAT I THINK HAS BECOME INCREASINGLY DIFFICULT FOR ANY ACADEMIC INSTITUTION AND AGAIN THE CANCER CENTERS AS WELL HAS BEEN THE COST OF ACTUALLY DOING THESE CLINICAL TRIALS. ABSOLUTELY PROHIBITIVE AT THE COST OF $2,000 PER CASE. WHICH ELIMINATES A NUMBER OF REALLY ACTIVE CENTERS THAT NEED TO BE PART OF THIS PROGRAM, BUT AGAIN IN MANY INSTITUTIONS THEY HAVE REALLY BEEN LIMITED IN TERMS OF PARTICIPATING BECAUSE OF THE COST WHICH MADE IT COMPLETE PLEA UNREALISTIC FOR THEM TO PARTICIPATE. SO I THINK THE RESPONSE HERE IN TERMS OF DECREASING ACCRUAL, PUTTING MORE ATTENTION ON THE PROTOCOLS THAT ARE GOING TO BE ACCEPTED FOR EVALUATION IN THIS SYSTEM AND THEN PAYING MORE FOR THE CASES PARTICULARLY PAYING FOR CENTERS THAT ARE TRULY INTERESTED IN THIS TYPE MUCH TRIAL IS A STEP FORWARD. THEN LASTLY, I THINK AS MIKE HAS SAID MAKING USE OF BIOBANKS, BIOMARKERS, THE IMAGING SCORES ARE MUCH MORE EFFICIENT WAY OF DOING CLINICAL STUDIES. THE BOTTOM LINE OF ALL OF THIS PUTS THE COOPERATIVE GROUP SYSTEMS SPONSORED BY NCI AS BEING REALLY MUCH MORE RESPONSIVE TO THE NEEDS FOR THE FUTURE OF DOING CLINICAL TRIALS. >> I WON'T REPEAT THE STRONG POINTS THAT WERE MENTIONED. I WILL MAKE ONE COMMENT WHICH IS I STILL HAVE LINGERING CONCERNS ABOUT WHETHER SPECIALTY RESEARCH CAN STILL GO ON, THERE IS STILL RESEARCH IN RADIATION THERAPY AND SURGERY AND IT'S OF A MORE TECHNICAL NATURE. WHETHER THIS STRUCTURE WILL SUPPORT THAT I GUESS HAVE TO SEE. I THINK THAT THE STRONG POINTS OF THIS PROPOSAL GREATLY OUTWEIGH THE WEAK POINTS. >> I THINK THIS IS REALLY IMPORTANT. BY THE SAME TOKEN YOU WOULD HAS PROCESS IN THE CONTINUUM AS THIS COMES BACK, IN A FEW YEARS, FIVE YEARS NOR REASSESSMENT THAT WE WILL BE FARTHER ALONG COMING LONG WAY TO MAKE SURE THAT WE HAVE ROBUST CLINICAL TRIAL SYSTEM. I THINK IT LAYS THE GROUND WORK FOR IN WHICH CALL TRIALS TO ASK BIGGER QUESTIONS THAT ARE MORE ESSENTIAL THAT WILL MOVE THE FIELD AND IMPROVEMENT FORWARD. SO I THINK WE'VE MOVED HA HUGE LONG WAY. WE HAVE MUCH FARTHER TO GO I THINK THIS CREATES A STRUCTURE THAT ALLOWS THE COOPERATIVE GROUP SYSTEM TO BE NIMBLE IN THE QUESTIONS IT HAS ASKED. >> I THINK VERY IMPRESSIVE AND REALLY SUBSTANTIAL WORK AND REALLY CONGRATULATE YOU. I WAS PLEASED TO HEAR SEVERAL MENTIONS OF QUALITY OF LIFE AS VALUED MEASURE OF CLINICAL TRIALS AND I HAVE TWO COMMENTS ABOUT THAT. ONE IS IN ALL OF THE LISTS OF SLIDES AND IDENTIFICATION OF LEADERS ACROSS THE GROUPS I NOTICED THAT THERE WAS ONLY ONE NAME IN ALL THE PRESENTATION THAT WAS NOT AN M.D. AND WE KNOW THAT THERE ARE MANY PSYCHOLOGISTS, NURSES, PEOPLE FROM OTHER DISCIPLINES THAT HAVE DONE MUCH TO CONTRIBUTE TO UNDERSTANDING QUALITY OF LIFE. SO I HOPE THAT THERE ARE EFFORTS TO MAKE THE -- THIS SORT OF NEW STRUCTURE OF CLINICAL TRIAL WORK ALSO INTRODUCE -- INTER-DISCIPLINARY. SECOND, ACROSS THE 20 YEARS THAT I'VE BEEN INVOLVED I THINK SO OFTEN WE SAY THAT WE'RE ASSESSING QUALITY OF LIFE IN CLINICAL TRIALS IN REALITY WE HAVE SIMPLE MEASURES OF FUNCTION WE DON'T TRULY ASSESS QUALITY OF LIFE. GIVEN MANY OF THE NEW THERAPIES THAT HAVE EXTREME TOXICITY AND CREATE VERY IMPORTANT PHYSICAL SYMPTOMS AND BURDEN. WE KNOW THAT THERE ARE OTHER ASPECTS OF QUALITY OF LIFE THAT REALLY CAN HELP US MAKE BETTER DECISIONS ABOUT TREATMENTS. SO I HOPE THAT WITHIN THIS REDEFINE THAT ONE OF THE SUBSTANTIAL THINGS TO GIVE SOME THOUGHT AS TO THE QUALITY OF QUALITY OF LIFE RESEARCH. THE QUALITY OF MEASURES WITHIN THESE TRIALS THAT WILL REALLY FACILITATE TREATMENT DECISIONS. >> CHRISTINE AND JIM. >> I HAVE TWO COMMENTS, QUESTIONS. I'VE BEEN THE CHAIR OF THE MOLECULAR EPI COMMITTEE FOR A NUMBER OF YEARS. WE'RE ALWAYS SCRAMBLING TRYING TO FIND SUPPORT FOR COLLECTION OF BLOOD ALONGSIDE TRIALS I'M WONDERING THAT THAT WILL BE PART OF THE ENHANCED REIMBURSEMENT. THEN MY SECOND I'M WONDERING WHAT IS GOING TO HAPPEN TO CANCER PREVENTION AND CONTROL IF THAT WILL GO IN TO THE SEPARATE CCOP GRANT OR BE REORGANIZED. >> I MIGHT HAVE THE DOCTOR ANSWER YOUR SECOND QUESTION. WE HOPE AS PART OF EMPHASIZE GOING FORWARD PART OF THIS RFA TO HAVE COLLABORATIVE MANAGEMENT TEAM WITH THE NETWORK GROUP SO THAT WE CAN DISCUSS HOW BEST TO PUT BIOSPECIMEN COLLECTION AND OTHER COLLECTION WITHIN DEFINITIVE TRIAL. WE WILL, WE DO HAVE SEPARATE FUNDING FOR COLLECTION FOR BIOSPECIMEN EVEN WHEN THEY'RE NOT INTEGRAL TO THE STUDY QUESTION. BUT IT'S A -- WE NEED TO HAVE PRY OTHER IF I SAKES ON THOSE ISSUES WHEN TO COLLECT THAT -- WHEN TO COLLECT THOSE. PART OF THE CONTROL NEW RFA HAVING AN INTEGRATED NETWORK AND COLLABORATIVE NETWORK FOR US TO HAVE COLLABORATIVE MANAGEMENT TEAM TO LOOK AND ADDRESS WHERE BEST TO DO THOSE COLLECTIONS AND MAKE SURE THAT THEY GET DONE. I'LL HAVE LORI ANSWER YOUR SECOND QUESTION. >> THANK YOU. SO THE RESEARCH BASE, CANCER PREVENTION AND CONTROL WILL CONTINUE TO BE FUNDED THROUGH THE C-COPY SEARCH BASIS. WE'RE MOVING FORWARD WITH TRANSFORMATION FOR THE TREATMENT GROUP OR GRANTS FIRST, CANCER CONTROL PIECE WILL FOLLOW OUR RFA WILL -- WE WILL LOOK AT THE WHOLE STRUCTURE OF THIS CONTINUE TO WORK IN A WAY THAT THE RESEARCH BASE WILL REFLECT THE SAME LEVEL. SO THAT THE APPROACH ABSOLUTELY IS TO BE INTEGRATED AND CANCER PREVENTION AND CONTROL TO BE INCLUDED THAT INCLUDES QUALITY OF LIFE NOT JUST THE HEALTH RELATED QUALITY OF LIFE TOOLS BUT ALSO FUNCTIONAL ASSESSMENTS AS ENDPOINTS SECONDARY AND MAYBE EVEN PRIMARY ENDPOINTS ON SOME OF OUR CLINICAL TRIALS. THE WHOLE GOAL IS TO HAVE INTEGRATION BETWEEN THE TWO TYPES OF RESEARCH GROUP. >> I AGREE WITH MIKE AND SUBCOMMITTEE THAT THE ORGANIZATION IS A GOOD THING, IT'S BEEN OVERDUE. I DO HAVE COUPLE OF COMMENTS THEN A QUESTION ON HOW THIS AFFECTS PATIENT ADVOCACY. THREE OR FOUR OF YOUR SLIDES INDICATED THAT PATIENT ADVOCATES BEHALF CLOSELY INVOLVED IN DESIGN AND DEVELOPMENT AND CONDUCT OF TRIALS. ADVOCATES ARE ASKED HOW A TRIAL COULD BE CHANGED TO IMPROVE ACCRUAL. UNFORTUNATELY THE REALIGNMENT HAS REALLY IMPACTED ADVOCACY. NEW ALLIANCE GROUP FOR INSTANCE BROUGHT TOGETHER 39 ADVOCATES -- 39 ADVOCATES, 1 CAME FROM -- 12 FROM NTTCG AND 14 FROM CALGB. 39 NOW ONLY NUMBER 20 WE'VE LOST HALF OF OUR VERY EXPERIENCED ADVOCATES, WE'RE TOLD THAT IT'S BECAUSE OF FUNDING. WE'RE NOT PAID MOST OF OUR TRAVEL EXPENSES ARE. MY QUESTION IS THIS. HOW CAN THE NCI HELP TO RETAIN AND UTILIZE THIS VALUABLE EXPERTISE, SOME OF THE LOST PEOPLE, 16, 17, THERE WAS 18-YEAR PERSON WE DON'T HAVE SPACE FOR. PLEASE DON'T TEMP US THAT IT'S NOT AN NCI ISSUE THAT IT'S ONLY COOPERATIVE GROUP DECISION BECAUSE IT IS AN NCI ISSUE. YOU'VE ENCOURAGED ADVOCACY, YOU'VE TRAINED MANY MUCH US. PLEASE TELL US HOW THE NCI CAN HELP KEEP ADEQUATE NUMBERS OF ADVOCATES ON EACH DISEASE MODALITY COMMITTEE WITHIN THE COOPERATIVE GROUP STRUCTURE. >> WELL, WE ABSOLUTELY AGREE. IT IS AN NCI ISSUE AS WELL. WE GREATLY VALUE PATIENT ADVOCATES AS DO THE GROUPS. I THINK WE'RE GOING TO HAVE A LITTLE BIT OF A LEARNING PROCESS HERE IN TERMS OF CONSOLIDATING THE GROUPS AND SEEING HOW THINGS SHAKE OUT AT A RECENT MEETING. THEY ALSO BROUGHT UP THIS ISSUE OF PATIENT ADVOCACY. I THINK WE'RE FULLY COMMITTED OBVIOUSLY TO HAVING PATIENT ADVOCATES INVOLVED IN THE SYSTEM BECAUSE IT'S ESSENTIAL TO HAVE THEM INVOLVED. WE DO HAVE A PATIENT ADVOCACY STEERING COMMITTEE. WE'RE HOPING TO BE ABLE TO BRING THIS ISSUE TO THEM AS WELL, TO HELP ADDRESS THIS AND TO SEE HOW WE CAN MAKE SURE THAT THE ADVOCATES THAT HAVE BEEN LONG TERM SUPPORTERS AND INVOLVED IN THE NETWORK CONTINUE TO BE INVOLVED IN THE NETWORK. I DON'T EXACTLY KNOW HOW THAT WILL SHAKE OUT SPECIFICALLY. JEFF MAY HAVE ADDITIONAL COMMENTS WE'RE WELL AWARE THAT THIS ISSUE HAS BEEN BROUGHT TO US VERY RECENTLY WITH THE CONSOLIDATION AND AFFECT IT'S HAVING ON THE PATIENT ADVOCATES. >> I JUST WANT TO ADD VERY BRIEFLY THAT ALTHOUGH WE MAY HAVE FEWER GROUPS MAYBE BE FEWER ADVOCATES PER GROUP THAT AS MEG SAID HAS TO SHAKE OUT. C, WHAT'S NEEDED AND WHAT WILL BE USEFUL. WE PROBABLY WILL NEED MORE ADVOCATES ON OUR CENTRAL IRBs WE'LL NEED MORE ADVOCATES ON OUR CTAC ADVISORY COMMITTEE. WE HAVE THE PATIENT ADVOCACY STEERING COMMITTEE. I DON'T THINK, IN FACT I THINK IN THIS NEW STRUCTURE ADVOCATES WILL BE MORE TIGHTLY INTEGRATED AND INVOLVED IN THE WHOLE NETWORK AS OPPOSED TO PERHAPS FUNCTIONING AS THEY HAVE IN THE SINGLE GROUP. >> JOE, ANDRE I CAN'T, THEN KAREN. >> ANTICIPATING THAT FIVE YEARS FROM NOW WE WILL KNOW HOW TO DO COMPLETE GENOMIC ANALYSES. HOW ARE THE PATIENTS BEING CONSENTED, NUMBER ONE. NUMBER TWO, ARE YOU MAKING ANY COMMENTS ON DATA AVAILABILITY POLICIES? >> I'LL LET DR. ABRAMS ADDRESS THIS WE'RE IN THE PROCESS OF REDOING THE INFORMED CONSENT TEMPLATE FOR THE NCI CLINICAL TRIAL. I THINK PART OF THIS COMES AT THE BEHEST OF THE NEW RULES THAT ARE BEING PUT OUT FOR PUBLIC COMMENT BY THE FDA AND OHRP THAT'S A POSITIVE STEP I THINK IN THE RIGHT DIRECTION. BUT WE ARE ACTUALLY GOING THROUGH AN NCI-WIDE PROCESS OF CHANGING THE INFORMED CONSENT TEMPLATE. AND MAKING SURE THAT WE INCORPORATE IN THE NEW TEMPLATE THE ABILITY TO COLLECT TISSUE FOR ALL THE DIFFERENT GENOMIC TESTS THAT ARE GOING TO BE NECESSARY. SO WE AGREE WITH YOU THAT THIS IS CRITICAL AND THAT WE HAVE TO ADDRESS THIS UP FRONT SO THAT WE DON'T RUN IN TO PROBLEMS WITH HAVING TO GO BACK AND GET CONSENT, WHICH IS AS YOU KNOW VERY DIFFICULT TO DO AND COSTLY. SO HOPE. LY THAT WILL BE HANDLED PROSPECTIVELY. >> CAN I DIRECT A FOLLOW UP TO THAT? SEEMS THAT THERE'S INHERENT TENSION IN THE DUAL GOALS OF INCREASING OPERATIONAL EFFICIENCY AND GETTING TRIALS OPEN MUCH MORE QUICKLY THAN HISTORICALLY AND AT THE SAME TIME INCREASING SCIENTIFIC INNOVATION WHICH WILL ADD SIGNIFICANT DEGREE OF COMPLEXITY WHICH ONE WOULD IMAGINE WOULD NORMALLY SLOW THINGS DOWN. HOW DO YOU MANAGE -- HOW DO YOU IMAGINE BALANCING THOSE OPPOSING FORCES? >> I WILL ALSO LET DR. ABRAMS HANDLE THAT. >> YOU POINT OUT SOMETHING THAT IS BURDEN ON THE TRIALS WE VIEW IT AS AN OPPORTUNITY, WE'RE READY TO -- I THINK THE COOPERATIVE GROUPS HAVE DONE THIS. ALL HAVE TO -- IT ISN'T WORTHWHILE TO HAVE A GREAT SCIENCE QUESTION THAT TAKES YOU TWO YEARS TO OPEN. THAT ISN'T THE EBBED GAME. WE HAVE TO BE ABLE TO DO TO BE SHOW TO OUR INDUSTRY PARTNERS THAT WE CAN OPEN THE TRIALS IN THE SAME TIMEFRAME AS THEY WERE RUNNING A TRIAL WE CAN ADD SOME SCIENCE TO IT THAT HOPEFULLY WILL ASK MR. QUESTIONS ABOUT WHERE TO GO NEXT. I THINK, WE HAVEN'T QUITE GOT TO OUR TARGETS YET. WE'VE REDUCED BY 50%, I THINK WITH MORE INNOVATION, USE OF TECHNOLOGY WE CAN PROBABLY GO THE REST OF THE WAY. >> I DIDN'T QUITE GET -- THE SECOND ANSWER. IN TERMS OF THE THOUGHTS ON REQUIRING, FOR EXAMPLE, THAT THE DATA THAT GENERATED IN THE TRIALS DON'T MAKE -- CLINICAL METADATA BE MADE PUBLICLY AVAILABLE AT THE TIME OF PUBLICATION. I THOUGHT VERY BENEFICIAL IMPACT ON TCGA PROJECT. I THOUGHT IN THE CONTEXT OF THE CLINICAL GROUPS NOT NECESSARY PLEA STRONG CONSENSUS ON THAT. >> OBVIOUSLY WE HAVE ACTUALLY A REQUIREMENT TO HAVE DATA SHARING. I THINK WHAT COMPLICATES IT, JEFF CAN SPEAK TO THIS AS WELL THAT OCCASIONALLY ON SOME TRIALS WE DO HAVE INDUSTRY PARTNER. THEY MIGHT BE MAKING A LICENSING INDICATION GOING FORWARD WITH THE FDA WITH THE MARKETING APPLICATION. THERE ARE SOME CONTINGENCIES DEPENDING ON THE TYPE OF TRIALS. BUT WE ARE COMMITTED TO MAKING SURE THAT WE DO HAVE DATABASES AND DATA SHARING OF TRIALS AS SOON AS WE CAN MAKE THEM PUBLICLY AVAILABLE. I THINK THAT IS SOMETHING THAT WE HAVE TO ADDRESS AND SORT OUT GOING FORWARD. IT WILL BE MUCH EASIER TO DO THAT ACTUALLY WITH AN INTEGRATED NETWORK WITH EVERYBODY AT THE TABLE THAN IN THE PAST WHEN INDIVIDUALLY EACH GROUP SET OUT THEIR OWN DATA SHARING POLICY, ET CETERA. THAT IS DEFINITELY AN AREA GOING FORWARD WILL BE ADDRESSING. >> JUST TO CLARIFY THAT YOU'RE SUGGESTING THIS WOULD BE PATIENT LEVEL ANNOTATION NOT AGGREGATE? AS I UNDERSTAND IT'S A HUGE DEPATURE FROM THE TASK. IS THAT WHERE YOU'RE HEADING? >> THE LEVEL OF THE DATA REALLY HAS TO BE LOOKED AT IN EACH TRIAL. I DON'T KNOW THAT WE CAN GIVE BLANKET POLICY BECAUSE AS MEG SAID ALL SORTS OF CONTRACTUAL AND AGREEMENTS THAT WE HAVE TO LOOK AT IN EACH TRIAL. BUT IT IS THE NCI POLICY, DATA SHARING POLICY THAT WE WILL MAKE THAT DATA AVAILABLE WIDELY PUBLICLY AVAILABLE. WHEN THERE ISN'T ANOTHER CONTINGENCY WE HOPE TO BE DOWN AT THE LEVEL OF THE INDIVIDUAL PATIENT. >> IN A HUGE CLINICAL TRIAL THERE'S MANY MORE DATA POINTS WHICH MAKES IT A BIGGER OPERATION TO KEEP IT UPDATED BECAUSE EVEN WHEN YOU GET YOUR FIRST ENDPOINT AT TRIAL YOU ARE CONTINUING TO COLLECT MORE INFORMATION UTILIZING THAT INFORMATION. IT'S A CHALLENGE, TOO. THERE AREN'T THAT MANY CLINICAL TRIAL ORGANIZATIONS AROUND THE WORLD YET WHO HAVE PUT OUT THE PROPER TEMPLATE FOR PUBLIC SHARING OF PATIENT LEVEL DATA. BUT I THINK IT'S A GOOD GOAL. >> JUST TO CONTINUE WITH THE LAST COUPLE OF QUESTIONS, DESPITE RECOGNITION FOR GREAT STRENGTH OF THE PROPOSAL I WONDER IF WE'RE MISSING AN OPPORTUNITY HERE TO BE BOLDER IN TERMS OF DEFINING A ROLE OF GENOMICS IN THE CONTEXT OF CLINICAL TRIALS BECAUSE I'VE SEEN THE WORD BIOMARKERS APPEAR COUPLE OF TIMES IN THE PRESENTATION BUT IF IT IS PRESENTED THAT WAY YOU'LL GET WHATEVER THE PEOPLE THAT -- WILL IN TURN TO BE CURRENT LEVEL OF INTEGRATION. YOU HAVE TO BE A LITTLE BIT MORE SPECIFIC IN THE ROLE THAT GENOMICS CAN HAVE IN THE -- IN THIS TYPE OF STUDIES BECAUSE OTHERWISE THE DATA WILL BE COMPLETELY FRAGMENTED AND NOT WELL INTEGRATED. ONE THING THAT IS NOW EMERGING VERY CLEARLY IS THAT ABILITY TO COLLECT PATIENT DATA ON NONRESPONDER ARM OF THE CLINICAL TRIAL REALLY VALUABLE AND IT'S EXTRAORDINARILY DIFFICULT TO GET ACCESS TO THAT KIND OF DATA. AND IF IT'S IN THE RFA PEOPLE WILL ADAPT AND WRITE TO IT. BUT OTHERWISE SOME PEOPLE MAY DO IT, SOME MAY NOT DO IT. I THINK THERE IS POTENTIAL HERE FOR BETTER DEFINING THE ROLE OF GENOMICS IN CLINICAL TRIALS. [ NOT AUDIBLE ] [LAUGHTER] >> I WONDERED IF YOU COULD SPEAK TO THE DIVERSITY OF THE PATIENT POPULATION THAT HAVE BEEN ACCRUED THROUGH THE NETWORK SO FAR AND WHETHER OR NOT, PARTICULARLY FOR CANCERS WHICH THERE ARE SOME DISPARITIES. I WONDER IF YOU ALSO COULD HYPOTHESIZE WHAT YOU THINK THE IMPACT OF THE REDUCED ACCRUAL WILL BE ON THAT, WILL IT MAKE IT BETTER, WORSE, HOW IS THAT GO TO GO PLAY OUT? >> WELL, ACTUALLY IN TERMS OF DIVERSITY OF PATIENT POPULATION THIS PROGRAM IS ONE OF THE FEW PROGRAMS THAT ACTUALLY CONDUCTS CLINICAL TRIALS OUT IN THE PUBLIC, IN THE COMMUNITY, AT THE LEVEL ACROSS NORTH AMERICA. WE ACTUALLY DO GET A VERY DIVERSE PATIENT POPULATION. WE DO HAVE GOOD REPRESENTATION DIFFERENT DISEASES, WE -- BIG COMPONENT THAT HAVE IS IN PEDIATRIC ONCOLOGY IN PARTICULAR BUT ALSO IN RARE TUMORS IN THE U.S. IN FACT IN THE RFA CONCEPT THERE'S TABLE THAT GOES THROUGH THE ACCRUAL BY PARTICULAR DISEASE TYPE. NOW, IN RELATION TO THE INCIDENTS I THINK THAT IS SOME WHERE, AS WE MENTIONED WITH A REDUCTION IN ACCRUAL THAT WE NEED TO HAVE HELP IN TERMS OF STRATEGIC PLANNING AND SUBCOMMITTEE WITH CTAC MAKE SURE THAT WE BALANCE THE PORTFOLIO THAT WE MAKE SURE, BECAUSE CERTAINLY ONE AREA THAT INDUSTRY WOULD NOT NECESSARILY DO CLINICAL TRIALS IN ARE IN RARE TUMORS, THAT IS OBVIOUSLY A VERY BIG PART OF OUR PUBLIC MISSION. AND WE HAVE TO MAKE SURE THAT WE LOOK AT THAT AS WE BALANCE THE PORTFOLIO. >> AS FAR AS MINORITIES, ABOUT 10% OF OUR COOPERATIVE GROUP TRIALS DO INCLUDE -- HAD TRADITIONALLY HAD AFRICAN AMERICAN PARTICIPATION, GOOD ASIAN PARTICIPATION LIKE MOST TRIAL ORGANIZATIONS IT'S CHALLENGING TO HAVE NATIVE INDIAN PARTICIPATION BUT WE DO TRY, ESPECIALLY IN SEVERAL C-COPS AROUND THE COUNTRY. I THINK THIS PROP HAS DONE REASONABLY WELL, WE COULD ALWAYS DO BETTER BUT IN ACCRUING MINORITY POPULATION IN THE COUNTRY TO THESE TRIALS, ALTHOUGH ACCRUAL MAY BE SOMEWHAT LESS THAN 25,000, I DON'T SEE THAT AS A REASON FOR IT DROPPING DOWN. STILL INTEND TO HAVE MINORITY-BASED C-COPS WE HOPE THAT MINORITIES WILL NOT SUFFER ANY WAY FROM THIS DID I CREASE IN ACCRUAL. >> WE WOULDN'T EXPECT THAT TYPE OF DIVERSIFICATION BE AFFECTED BY ACCRUAL. >> I HAVE A COUPLE OF SORT OF FINANCIAL QUESTIONS, YOU'LL EXCUSE ME I JUST ENDED FROM CPAs. WE'RE GOING TO INTEGRATE THESE 11 ORGANIZATIONS IN TO FOUR WITH PRESUMABLY SOME OVERHEAD SAVINGS AND YET WE'RE GOING TO DECREASE OUR PATIENT THROUGHPUT BY 20%. THAT IS NOT ALL GOING TO COVER THE INCREASE PATIENTS FOR ENROLLMENT IS MY FIRST COMMENT I'D LIKE YOU TO ADDRESS THAT. NUMBER TWO, IT'S INTERESTING TO ME EVEN WITH THE CHANGE IN THE NUMBERS IT'S A STABLE RATIO OF OVER TWO-THIRDS OF THE COSTS AREN'T GOING TO ACTUALLY ENROLLING PATIENTS AND TREATING PATIENTS WHICH AGAIN STRIKES ME AS HIGH. IT'S LIKE A CHARITY WHERE TWO-THIRDS OF THE MONEY IS GOING TO ADVERTISING NOT TO DOING THEIR CHARITABLE FUNCTION. ALTHOUGH ADMITTEDLY THIS ISN'T ADVERTISING. NUMBER THREE, YOU MENTIONED JUST IN PASSING THAT SOME OF THESE TRIALS ARE DONE IN COLLABORATION WITH THE PHARMACEUTICAL INDUSTRY. IS THERE MORE OF AN OPPORTUNITY TO LEVERAGE THAT AND TO -- HOW MUCH OF THE PRIOR BUDGETS YOU SHOWED A BUDGET OF ROUGHLY 150-170 MILLION A YEAR. HOW MUCH ADDITIONAL SUPPORT ARE YOU NOT SHOWING THAT WE'RE GETTING FROM PHARMA AND IS THERE A WAY TO GROW THAT. >> OKAY. LET ME BACKTRACK. IN TERMS OF THE SAVINGS IN TERMS OF OVERHEAD AN CONSOLIDATION WE DO EXPECT TO HAVE SAVINGS EVENTUALLY. I DON'T THINK WE EXPECT THEM IN THE FIRST FIVE YEARS. THE REASON FOR THAT IS OBVIOUSLY WE HAVE TO CONSOLIDATE ON THIS AS LARGE SYSTEM AND WE HAVE TO DO THAT IN A CONTROLLED WAY, MANAGED WAY, WE ACTUALLY HAVE TO PROVIDE ADDITIONAL FUNDING IN ORDER TO FACILITATE THAT CONSOLIDATION. THE LONG TERM WE DO EXPECT TO HAVE SOME EFFICIENCY COST SAVINGS RELATED TO THAT OVERHEAD. THAT WAS YOUR FIRST QUESTION. SECOND QUESTION -- [ NOT AUDIBLE ] THE GROUP OPERATION CENTER THAT WHERE YOU SEE THAT FUNDING YOU CAN'T JUST PICK THAT HAIR YES BECAUSE ESSENTIALLY THE GROUP OPERATIONS OFFICES ALSO PAY FOR SOME OF THE PER-CASE REIMBURSEMENT. I JUST TOOK OUT THE ADDITIONAL $25 MILLION THAT IS GOING TO BE NEW THAT IS TOTALLY GOING TO GO EX IS SEEP FOR $4 MILLION FOR INTEGRATED MARKERS AND STUD EATS GOING TO GO SITES. THE LAMB IRRELEVANT HOLE PAYS OUT REST OF THE ACCRUAL. WE DO EXPECT THAT THE RATIO FROM INFRASTRUCTURE TO PARTICIPATION HISTORICALLY HAS BEEN ABOUT 60-40. WE HOPE WITH THIS INCREASED MODEL WE'LL CHANGE THAT MORE TO 50-50. LAST QUESTION ABOUT INDUSTRY, ONE OF THE FEATURES OF THE COOPERATIVE AGREEMENT WE ARE ALLOWED UNDER THAT AGREEMENT TO HAVE THE GROUP NETWORKS PAY IN ADDITIONAL FUNDS FOR THINGS THAT EITHER NCI DOES NOT COVER IN WHOLE OR FOR THINGS THAT WE DON'T COVER AT ALL. THE ESTIMATE THAT WE MADE FOR IN-KIND CONTRIBUTION TO PROVIDE ESTIMATE OF WHAT INDUSTRY PROVIDES THE COOPERATIVE GROUPS. THAT'S ABOUT $40 MILLION A YEAR. NOW THAT USUALLY GOES NOT JUST -- THEY PROVIDE INCREASED THEY ALSO PROVIDED SUPPORT FOR AUDITING AND EXTRA DATA COLLECTION FOR THEIR TRIALS. PARTICULARLY IF ONE OF THE TRIALS MIGHT BE USED IN MARKETING APPLICATION. [ NOT AUDIBLE ] >> TO RETURN TO ONE OF THE CONCERNS THAT TED BROUGHT UP. EARLY ON YOU CITED 30 PROCESS CHANGING, THREE OR FOUR OF THE PUBLISHED THIS YEAR. THE TRIAL OF THE LYMPH NODE AND NCIC STUDY ARE LOCAL APPROACHES. MY FEAR IS THAT THOSE PROPOSALS IN 2012 WOULD NEVER REACH A LEVEL OF FUNDING THAT IS SORT OF INDUSTRY STUDY BECAUSE -- IS GOING TO BE WHEREVER THEY'RE GOING TO BE WITH -- RTOG -- I'M SERIOUS. IN TERMS OF THAT, THESE ARE PRACTICE CHANGING STUDIES THAT WERE DONE. MY GUESS, I WAS ON THE REVIEW COMMITTEE FOR -- THAT WAS A CONTROVERSIAL TRIAL. BUT MY SENSE IS TODAY THAT THAT WOULDN'T GET -- RISE TO THE LEVEL OF IMPORTANCE WITHIN SOME OF THE INTEGRATED STUDIES. JUST SITE THAT AS A CONCERN AS HOW THOSE ARE GOING TO BE ADDRESSED THEN WILL BE MORE EMPHASIS ON INTER-GROUP TRIALS. SOMEONE IS GOING TO COME UP -- COMPARE AS TO WHAT WE'VE DONE IN STAGE THREE LUNG CANCER OVER THE LAST 30 YEARS THERE'S NO PRACTICE CHANGING TRIALS THAT I KNOW OF. BUT THAT ASIDE BUT HOW DOES -- HOW DO THESE INTEGRAL TRIALS COME UP WITH A SUGGESTION, STAGE THREE COLON, MUTANT KRAS POSITIVE -- THERE'S 12 DIFFERENT STUDIES HOW ARE YOU GOING TO PRIORITIZE THOSE FROM THE THREE OR FOUR GROUPS TO COME UP INTEGRATING BIOLOGY. I JUST HOUSE POLITICS OF IT WITHIN THE STRUCTURE YOU SEE. >> FORTUNATELY WE'VE HAD PRACTICE WITH THE POLITICS WE'VE HAD THE DISEASE-SPECIFIC STEERING COMMITTEES FOR NEARLY FIVE YEARS NOW DATE BACK TO THE FIRST ONE IN GI CANCER AS YOU SAW ON THE SLIDE WE'VE ADDED ALL THE OTHER DISEASES IN SUBSEQUENT YEARS. I THINK THERE IS A LOT OF DISCUSSION THAT GOES ON WHICH TRIAL SHOULD BE PRIORITIZED GO FORWARD ON NATIONAL BASIS IN THE SYSTEM WE CURRENTLY HAVE THERE IS SOME DISINCENTIVE TO PARTICIPATING IN A TRIAL THAT'S NOT IN YOUR GROUP OR RAISED BY YOUR GROUP. THE NEW SYSTEM IS NOT GOING TO HAVE THOSE DISINCENTIVES. IF THE TRIAL IS PRIORITIZED IT'S TO YOUR BENEFIT AND GROUP BENEFIT TO PARTICIPATE IN THAT TRIAL BECAUSE YOU WILL BE RATED ON HOW WELL DO YOU TO THESE NETWORK TRIALS. WE HOPE TO OVERCOME THAT DISINCENTIVE PROBLEM. IN TERMS OF THE MAKING SURE THAT WE GET GOOD TRIALS I THINK THAT IS REALLY THE IMPORTANT JOB OF KNEES DISEASE SPECIFIC STEERING COMMITTEES AND OVERSIGHT COMMITTEES. HOPEFULLY -- AS I SAID WE'VE HAD SOME EXPERIENCE, THERE'S BEEN NO DECREASE REALLY IN SURGICAL OR RADIATION THERAPY TRIALS. IN FACT I THINK YOU MIGHT BE SURPRISED THE MEDICAL ONCOLOGISTS STILL SEEM TO PARTICIPATE AND LIKE THOSE LOCAL THERAPY TRIALS. I HAVEN'T SEEN THAT AS A REAL PROBLEM SO FAR AS AN OBSERVER OF ALL THE DISEASE-SPECIFIC STEERING COMMITTEE. PEOPLE STILL VALUE THOSE SORTS OF TRIALS. THREE-PART QUESTION. TO THE COLLECTING GENOMIC DATA BECOMES AVAILABLE TO EVERYONE EVENTUALLY. EVEN THOUGH I APPRECIATE THAT ON TRIAL SPECIFIC BASIS DIFFERENT DECISIONS HAVE TO BE MADE. FIRST STEP TOWARDS THAT GETTING CONSENT THAT WILL ALLOW THAT. SO ONE WOULD HOPE THAT AS DEFAULT THAT THAT TYPE OF CONSENT WOULD BE CONSIDERED OR AT LEAST PROMOTED. ONLY AS -- BECAUSE EVEN IF YOU HOLD THAT DATA BACK DURING COURSE OF THE TRIAL UNTIL THE FDA THING GOES THROUGH, THAT DATA COULD BECOME AVAILABLE THAT WON'T HAPPEN IF CONSENT ISN'T DONE. SECOND PIECE TO THAT OF COURSE IS THAT IF INDUSTRY IS DICTATING THE RULES IN TERMS OF THEN DATA GETS RELEASED THEY'RE GETTING THE BENEFIT OF ALL OF THIS PUBLIC MONEY NICE TO PLAY TO SOME EXTENT BY OUR RULES SINCE I THINK THEY'RE LARGELY LEVERAGING THE PUBLIC MONEY TOWARD. THIS I'M HOPING TO SOME EXTENT WE CAN PUT PRESSURE THERE. THEN FINAL QUESTION IS -- A LITTLE BIT UNRELATED BUT SOMEWHAT RELATED THAT WILL THIS NEW CONSOLIDATED STRUCTURE IMPROVE THE IRB PROCESS BOSNIA SO COMPLICATED THESE DAYS. IF THERE IS A CENTRALIZED WAY TO SIMPLIFYING THINGS THIS COULD BE A NOODLE WOULD HELP EVERYBODY EVENTUALLY. >> THE CENTRAL IRB HELPED WITH PHASE THREE TRIALS. WE WOULD LIKE TO EXPAND IT TO CERTAIN RANDOMIZED PHASE TWO TRIALS AS NEXT STEP. BECAUSE WE DO THINK THE INSTITUTION, IS THAT SHINE ON TO THAT HAVE SEEN SOME SIGNIFICANT BENEFITS IN TERMS OF TIME SAVING. IT HAS BEEN SUGGESTED AT DIFFERENT BOARDS OF THE NCI THAT NCI CONSIDER MANDATING THIS PARTICIPATION IN THE CENTRAL IRB WHEN A TRIAL HAS GONE THROUGH. THAT IS SOMETHING THAT WE ARE SERIOUSLY CONSIDERING. >> JUST WANT TO ADD ONE OTHER THING IN TERMS. IRB WE ALSO DO HAVE PILOT ONGOING RIGHT NOW TO ACTUALLY MAKE THE CENTRAL IRBs BOTH ADULT AND PEDIATRIC INDEPENDENT IRBs OF RECORD. SO THAT -- THEY'RE UNDERGOING ACCREDITATION. WE COME OUT WITH CENTRAL IRBs THAT ARE ACCREDITED. IN ADDITION LIKES TO EXPAND ON THE ADULT RANDOMIZED PHASE 2 WE ARE READY FOR THE PEDIATRIC TRIALS, OLEINES 2 TRIALS DONE BY COG AS WELL AS PHASE 3. WE'RE LOOKING AT ACTUALLY ADDING PHASE 1 TRIALS TO THAT PEDIATRIC CENTRAL IRB AS WELL. >> I WOULD ARGUE THAT THE DATA NEEDS TO BE ORGANIZED DEPOSITED SO THAT IT CAN BE AUDITED BY INDEPENDENT GROUP EVEN THE IT ISN'T USUALLY AVAILABLE. >> I JUST WANTED TO COMMENT ABOUT IRB ISSUES WITH PEDIATRICS I THINK IT'S GREAT THAT THEY HAVE A CENTRAL IRB. BUT DATA SHARING WITH PEDIATRICS IS A WHOLE ADDITIONAL LAYER OF COMPLICATIONS WHO HAS THE RIGHT TO CONSENT WHEN THAT SORT OF THING AND IF YOU HAVE A CENTRAL IRB THAT WOULD BE MUCH MORE EFFICIENT WAY TO GET ALL THAT HAVE DONE. >> IMPORTANT POINT. MIKE, WOULD YOU LIKE TO MAKE A RECOMMENDATION FOR HOW YOU THINK WE SHOULD PROCEED? >> I WOULD LIKE TO JUST ADDRESS ONE LAST ISSUE THAT IS THAT ANDREA RAISED ABOUT THE GETTING DATA FOR GENOMICS AND OTHER STUDIES. ABOUT SIX OR SEVEN YEARS AGO THE INFORMED CONSENT ACTUALLY ALLOWED PATIENTS TO ACCRUE TO CLINICAL TRIAL NOT DO THE CORRELATIVE STUDIES. I JUST WANTED TO SAY THAT IS SOMETHING WE SHOULD PROBABLY VISIT BECAUSE AS WE NOW FIND THERE IS SO MUCH VALUE IN THAT, DO WE WANT STUDIES GOING FORWARD THAT DON'T HAVE CORRELATIVE SCIENCE ATTACHED TO IT AS MANDATORY ATTACHMENT. SOMETHING WE SHOULD GIVE SOME THOUGHT TO IF IT'S SOMETHING. WITH THAT, I'D LIKE TO SAY THAT I'M PLEASED WITH THE RESPONSE MAKES MOTION THAT WE MOVE FORWARD TO APPROVE THIS RFA. THINK OTHER DISCUSSION? ALL IN FAVOR OF SUPPORTING THE NEW RFA? ALL OPPOSED? ANY ABSTENTIONS? BE GOOD IF WE COULD OFFICIALLY NOTE ALSO STRONG ENTHUSIASM FOR INCORPORATING INFORMED CONSENT THAT WOULD SUPPORT BROAD GENETIC AND GENOMIC STUDIES AS WELL AS MAKING DEFAULT BEING -- MAKING PATIENT LEVEL DATA AVAILABLE AT THE APPROPRIATE TIME UNLESS THERE ARE EXTENUATING CIRCUMSTANCES, WHICH COULD INCLUDE PEDIATRICS THE THAT CAN BE WORKED OUT OR PARTICULAR COMPANY REQUIREMENTS BUT GENERAL DEFAULT I THINK ENTHUSIASM FOR MAKING IT PUBLIC. >> THE DIFFERENCE BETWEEN BSA THEN NCAB REVIEWS IT NEXT, WASN'T THAT THE QUESTION YOU WERE ASKING? >> GOOD. THAT WAS EXCELLENT DISCUSSION, THANK YOU, THAT WAS GREAT. WE WILL TAKE A TEN-MINUTE BREAK AND COME BACK AT 2:30. >> OKAY. SO, OUR NEXT ITEM OF BUSINESS IS TO HEAR ABOUT WHAT THE NCI THINKING ABOUT GLOBAL APPROACHES TO THE CANCER PROBLEM AND WELL HERE FROM TED TRIMBLE. >> THANK YOU VERY MUCH. I'VE GOT THIS SLIDE JUST SHOWS WHAT THE ESTIMATES ARE FOR NUMBER OF CANCER DEATHS GLOBALLY BY 2030. AND AS YOU CAN SEE IT'S GOING TO BE DOUBLE WHERE WE STAND IN -- WHERE WE STOOD IN 2002 AND PERCENTAGE THAT OCCURS IN THE DEVELOPING WORLD IS GOING TO RISE, TOO, FOR REASON WHICH I'LL DISCUSS. LEAVING US WITH APPROXIMATELY 70% OF CANCER DEATHS OCCURRING IN THE DEVELOPING WORLD. THERE ARE A NUMBER OF POTENTIALLY MODIFIABLE RISK FACTORS FOR CANCER THAT I THINK WE SHARE AROUND THE WORLD AND CLEARLY WE CAN BOTH LEARN -- WE CAN LEARN FROM ONE ANOTHER AS WELL AS HELP DO RESEARCH TOGETHER TO AVOID THE DEVELOPMENT OF SOME OF THE CANCERS FROM THE TOBACCO IS ONE OF THE MOST IMPORTANT BEING RESPONSIBLE FOR APPROXIMATELY 17% OF CANCERS. CHRONIC INFECTIONS AND I THINK WE CAN BUILD ON THE GREAT WORK DONE BY OUR COLLEAGUES ATTHIAID AND WELLS AROUND -- NIAID WORKING AT INFECTIOUS DISEASE. WE HAVE VACCINES FOR HEPATITIS B AND FOR HUMAN PAPILLOMA VIRUS. WE'VE LEARNED HOW TO TREAT -- AS WORK GOING ON TO DEVELOP VACCINES FOR SOME OF THE OTHER CANCERS. OBVIOUS LEO BEES TEE IS A MAJOR ISSUE AND SOMETHING THAT WE REALLY NEED HELP FROM OTHER COUNTRIES AROUND THE WORLD BECAUSE WE DO HAVE HIGHEST INCIDENTS OF OWES TEE IN THIS COUNTRY. ALCOHOL INTAKE IS ANOTHER -- IT DOES HELP EXPLAIN WHY WE'RE SEEING GREATER NUMBERS OF CANCERS IN THE DEVELOPING WORLD. PEOPLE ARE LIVING LONGER AND LIVING TO DEVELOP CANCERS AS WELL IN THE DEVELOPED WORLD WE OBVIOUSLY SEE AN OLDER POPULATION WITH INCREASED CANCER RATES AS WELL. WE HAVE HAD A LOT OF INTERNATIONAL COLLABORATIONS FOR A LONG PERIOD OF TIME AND I'M JUST GOING TO CITE A FEW OF THEM. THE CANCER GENOME ATLAS PROJECT IS PART OF LARGE IRRELEVANT INTERNATIONAL CAN SORT YUM, THE INTER-NATION THAL GENOME. IF YOU GO TO THEIR WEBSITE THERE IS A VERY GOOD ASSORTMENT OF CANCERS THAT ARE BEING STUDIED AROUND THE WORLD OF WHICH OUR WORK IS A SUBSET. SIMILARLY WE'VE BEEN ACTIVE IN VARIETY OF EPIDEMIOLOGIC CAN SORE SHA TO THIS DAY. WE SET UP THE SCREENING NETWORK AND WE'RE -- AS WELL AS THE INTERNATIONAL TOBACCO CONTROL POLICY EVALUATION CONSORTIUM. THESE ARE A FEW OF THE INTERNATIONAL COLLABORATIONS WE HAVE UNDERWAY. A FEW OF THE PROJECTS THAT DCEG IS WORKING ON. THERE ARE MANY MORE I COULD HAVE LISTED IF WE LOOK AT CHINA, WE'VE HAD WHOLE VARIETY OF PROJECTS REALLY OVER THE LAST SEVERAL DECADES LOOKING EIGHT LIVER CANCER, NUTRITIONAL SUPPLEMENTS, ASTERISK CANCER, CERVICAL CANCER, LUNG CANCER, BENZENE EXPOSURE TO FACTORY WORKERS. USING THESE RESEARCH NETWORKS THEY HAVE ALSO BEEN ABLE TO CONTROL TRIALS OF THE HPV VACCINES. I ALSO WANTED TO CITE THE IMPORTANT WORK DONE IN PCR TO DEVELOP THE PROPHYLACTIC VACCINE BY THE STUDY, HERE WE SEE OUR DEPUTY DIRECTOR AND JOHN. DOUG IS DRESSED DOWN FROM THIS OCCASION, I'M NOT SURE -- BUT WE'RE VERY PROUD OF THE WORK THAT THEY HAVE -- THAT THEY DID TO MAKE POSSIBLE PROPHYLACTIC HPV VACCINE. DOUG HAS BEEN CONCERNED OVER THE LAST SEVERAL YEARS BY HIGH PRICE THAT HAS BEEN PUT ON THE VACCINE WHICH MADE IT LESS ACCESSIBLE IN THE DEVELOPING WORLD BUT AS OF JUNE MERCK MADE A PROMISE THAT THE PRICE WILL BE DOWN TO ONLY $4 A DOSE OR SOMETHING LIKE THAT. WE'VE HOPING THAT GABI WILL BE ABLE TO MAKE FINANCIAL PROVISION TO MAKE IT WIDESPREAD. SO, WE HAD A NUMBER OF INTERNATIONAL OFFICES THAT WERE STARTED BY DIFFERENT NCI DIRECTORS OVER A PERIOD OF TIME. AND I LIST THEM HERE. WE HAVE HAD THE OFFICE OF INTERNATIONAL AFFAIRS MOST RECENT DIRECTOR IS HERE. THE OFFICE OF LATIN AMERICAN CANCER PROGRAM DEVELOPMENT, THEIR FOUNDING DIRECTOR IS HERE. A SMALL NCI LIAISON OFFICE IN BRUSSELS. AND OFF OF CHINA CANCER PROGRAM DEVELOPMENT. DR. SNIDER WHO STARTED IS HERE. AS WELL AS INTERNATIONAL NETWORK FOR CANCER TREATMENT AND RESEARCH, ALSO -- SO THE PLAN AT THEIR NEW CENTER WILL SUBSUME ALL THESE OFFICES AND HELP PROVIDE COORDINATION OF NCI'S INTERNATIONAL ACTIVITIES. I'VE GOT A FEW SLIDES HERE SOMEWHERE, SOME OF THE GREAT WORK THAT OUR INTERNATIONAL OFFICES HAVE BEEN DOING. FOR EXAMPLE, THE MIDDLE EAST CANCER CONSORTIUM WHICH HAS BEEN IN EXISTENCE SINCE 1996 BRINGS TOGETHER CYPRUS, ISRAEL, PALESTINIAN AUTHORITY AND TURKEY. THEIR MAJOR PROJECTS ARE CANCER REGISTRIES AS WELL AS PALLIATIVE CARE. THE ALL IRELAND NATIONAL CANCER INSTITUTE CANCER CONSORTIUM BRINGS TOGETHER THE REPUBLIC OF IRELAND, NORTHERN IRELAND AND UNITED STATES. THEY HAVE HAD VARIETY OF PROJECTS FOCUSED ON PREVENTION, CLINICAL TRIALS, REGISTRY, EPIDEMIOLOGY, HEALTH ECONOMICS AND WE'VE BEEN ABLE TO HAVE PEOPLE FROM BOTH THE REPUBLIC AND NORTHERN IRELAND SPEND TIME WITH US, WE THINK THIS HAS BEEN A VERY PRODUCTIVE PROGRAM. WE'VE BEEN ACTIVE THROUGH OFFICE OF INTERNATIONAL AFFAIRS AND INTERNATIONAL UNION NOR CANCER CONTROL. WITH THE BREAST GLOBAL HEALTH INITIATIVE WHICH AS MANY OF YOU KNOW FOUNDED BY FRED ROUGH IN SON CANCER RESEARCH INSTITUTE AND SUSAN COMEN FOR THE CURE. WE'VE BEEN ACTIVE IN THE AFRICAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER, HELPING DEVELOPING SMALL GRANTS PROGRAM. TURNING NOW TO THE OFFICE OF LATIN AMERICAN CANCER DEVELOPMENT PROGRAM. A NUMBER OF THE PROJECTS THAT THEY HAVE UNDERTAKEN HERE WORKING WITH ASH FOR CERTAIN MALIGNANCIES. WORKING WITH ASCO ON TRAINING WORKSHOPS OF WHICH THREE HAVE NOW BEEN HELD WORKING WITH THE DCG AND DCCS ON CANCER EPIDEMIOLOGY PROJECTS. BEGINNING TO LOOK AT GALLBLADDER CANCER IN CHILE. BEGINNING LOOK AT CERVICAL CANCER AND CLOSE COLLABORATIONS WITH SUSAN COMEN. ONE OF THE ONGOING EFFORTS TO DEVELOP CANCER RESEARCH NETWORK WITH UNITED STATES, MEXICO, BRAZIL, CHILE, URUGUAY, ARGENTIN ALSO HOPE TO EXPAND THIS TO INCLUDE PERU, COLOMBIA AND PUERTO RICO. FOR THIS NETWORK THE PILOT STUDY IS MOLECULAR PROFILING OF STAGE TWO AND THREE BREAST CANCER IN LATIN AMERICAN WOMEN. OFFICE OF CHINA, CANCER PROGRAMS ESTABLISHED VERY GOOD WORKING RELATIONSHIP WITH THE CHINESE EQUIVALENT OF THE NATIONAL SCIENCE FOUNDATION WHICH IS CALLED THE NATURAL SCIENCE FOUNDATION. DEVELOPED COLLABORATIVE BIOMEDICAL THAT IS TRANS-HIH. WHICH WE HAVE PUT OUT A REQUEST FOR COMPETITIVE SUPPLEMENT LAST YEAR AND FOR THIS PROGRAM HAVE TO BE JOINT APPLICATIONS, PARALLEL APPLICATIONS WRITTEN IN ENGLISH, REVIEWED BY -- BOTH BY CHINESE COUNTERPARTS AS WELL AS IN THIS CASE NCI STAFF WE HAD MEETING IN AUGUST TO DECIDE WHICH GRANTS WERE TO BE AWARDED. WE HAVE REVIEW ON BOTH SIDES WE HOPE TO CONTINUE AND EXPAND THAT. WE HAVE VARIETY OF WORKSHOPS HERE WITH OUR CHINESE COLLEAGUE AND WE'RE PLANNING ONE OR TWO NOW FOR ONE BIOMARKERS ONE ON BUILDING THE EVIDENCE BASE. WE'VE ALSO REACHED OUT TO OUR CANCER CENTERS TO FIND OUT WHAT THEY'RE DOING INTERNATIONALLY, ONE OF THE THINGS -- WE WERE DELIGHTED TO DISCOVER HOW ACTIVE. FIVE EXAMPLES YOU HEARD FROM THE DOCTOR THIS MORNING ABOUT GOING TO THE UGANDA CANCER INSTITUTE, THE FRED HUTCHINSON HAS BEEN CLOSELY INVOLVED WITH HELPING THEM STRENGTHEN THEIR ACTIVITIES. UNIVERSITY OF NORTH CAROLINA WHEN CANCER CENTER IN THE CAPITAL OF MALAWI. UNIVERSITY OF MAYOR SOUTHLAND INVOLVED WITH NIGERIA. UNIVERSITY OF MICHIGAN INVOLVED WITH GHANA FOR LONG PERIOD OF TIME AND INDIANA UNIVERSITY STARTED CANCER CENTER ORIGINALLY BASED ON, HIV RESEARCH CENTER IN WESTERN KENYA. GOING TO PROVIDE SOME EXCELLENT MODELS HOW WE CAN STRENGTHEN OR WHAT WE'RE DOING IN AFRICA USING THE CLOSE RELATIONSHIP BETWEEN NUMBER OF OUR CANCER CENTERS AND SITES IN AFRICA. THIS IS GROUND BREAKING THAT WAS MENTIONED. WE SEE THAT THE CENTER WILL HAVE NUMBER OF ROLES. FIRST COORDINATION OF GLOBAL CANCER RESEARCH AND GLOBAL HEALTH ISSUES ACROSS THE NCI. WE ENVISION THAT THE CENTER WOULD WORK CLOSELY IN PARTNERSHIP WITH OTHER DIVISIONS, OTHER CENTERS AND OFFICES TO DEVELOP NEW INITIATIVES AND TO FACILITATE RESEARCH. WE ALSO WANT TO PARTNER WITH ARE OTHERS IN GLOBAL RESEARCH. FOGARTY, NIAID, THEY HAVE A RESEARCH NETWORK FOR VARIETY OF RESEARCH NETWORKS THAT REPRESENT AN INVESTMENT OF ABOUT $500 MILLION A YEAR. WE HOPE TO WORK WITH THEM EXPLORE OPPORTUNITY TO BUILD ON THE INVESTMENT THAT THEY HAVE MADE. SIMILAR OTHERS HAVE SET UP CENTERS OF EXCELLENCE THAT TWINS CENTERS IN THE DEVELOPING WORLD WITH UNIVERSITY IN THE DEVELOPED WORLD M. PRELIMINARY DISCUSSIONS HOW WE CAN BUILD ON THE WORK THAT THEY HAVE BEEN DOING. OUR CURRENT NCI FOGARTY PARTNERSHIP, ACCORDING TO DR. ROGER GLASS WHO HEADS FOGARTY, WE AT NCI HAVE STRONGER EQUIPMENT TO THEIR VARIOUS PROGRAMS THAN ANY OTHER INSTITUTE AT NIH BUT THE TWO THAT ARE -- WE'VE BEEN MOST CLOSELY INVOLVED IN THEIR BIG PROGRAMS OF THE INTERNATIONAL TOBACCO AND HEALTH RESEARCH, CAPACITY BUILDING PROGRAM AND HIREE SEARCH TRAINING PROGRAM. IN ADDITION WE'RE INVOLVED WITH THE NUMBER OF THE PROGRAMS FOR SCHOLARS, THERE ARE ALSO SOME POTENTIAL FOGARTY PROGRAMS THAT WE'RE LOOKING AT CLOSELY WITH REPRESENTATIVES TO MIGHT BE APPROPRIATE FOR US TO INTER-ACT OR TO JOIN. THIS ONE FOR CHRONIC NCDs AND DISORDERS ACROSS LIFE SPAN, THIS IS SETTING UP CENTERS OF EXCELLENCE, THERE'S OUR CURRICULUM DEVELOPMENT FOR RESEARCH. DON'T HAVE CAPABILITY TO MONITOR AND RUN GRANTS AND CONTRACTS, THE NATIONAL SCIENCE FOUNDATION HAS PROJECT ON ECOLOGY AND EVOLUTION OF INFECTIOUS DISEASES. FOGARTY IS COSPONSORING WE'RE LOOKING CLOSELY AT THAT. FRAMEWORK INNOVATIONS IS AGAIN A PROGRAM OF CAPACITY BUILDING FOR RESEARCH INFRASTRUCTURE AND MEDICAL EDUCATIONAL PARTNERSHIP INITIATIVE IS FOCUSED ON HELPING BUILD -- HELPING STRENGTHEN THE DEVELOPMENT OF DOCTORS AND NURSES IN AFRICA AND SOMETHING THAT -- HAVE HAD EXTENSIVE DISCUSSIONS HOW WEEK BEST SUPPORT THAT. WE ALSO WANT TO CONTINUE TO PARTNER WITH OTHER HHS AND CENTRAL AGENCIES, CDC, FOR EXAMPLE, OBVIOUSLY HAVE A HUGE GLOBAL FOOTPRINT BUT THEY HAVE NOT UNTIL VERY RECENTLY HAD THEIR PEOPLE PLACED AROUND THE WORLD FOCUSED ON SPECIFICALLY ON CANCER ISSUES, THEY HAVE BEEN THINKING ABOUT INFECTIOUS DISEASE ISSUES BUT SOME AREAS OF CROSSING BUT WE'RE EXCITED ABOUT THE FACT THAT THEY'RE REALLY MAKING A COMMITMENT NOW OF SENDING PEOPLE OUT IN TO THE FIELD. FOCUSED ON THE PRODUCT OF DISEASES THAT ARE OF INTEREST TO US AS WELL. CONTRACT SNYDER AND I TALKING ABOUT NIH DELEGATION VISITING BEIJING IN AUGUST TO FINALIZE THE FIRST OF THE COMPETITIVE SUPPLEMENT PROGRAMS, WE VISITED THE U.S. D DOCTOR D -- CDC OFFICES AND WORKING ON NONCOMMUNICABLE DISEASES, HE WAS TARGETING OBESE TEASE, TOBACCO CONTROL HE WAS -- WE'RE HOPEFUL TO HAVE VERY CLOSE WE THAN TO WORK WITH PEPFAR WHO WANT TO STRENGTHEN THEIR RESEARCH COMMITMENT SUCH AS THROUGH RED RIBBON/PINK RIBBON IN NICHE SIEVE. YORK WITH US AID AND GOOD WORKING RELATIONSHIP WITH W.H.O. AND INTERNATIONAL AGENCY FOR RESEARCH ON CANCER, INTERNATIONAL ATOMIC ENERGY AGENCY AND REGIONAL AND COUNTRY WHOP OFFICES. WE ALSO WANT TO WORK CLOSELY WITH OUR PROFESSIONAL SOCIETY, WITH AACR, MERGE COLLEGE OF SURGEONS, ONCOLOGY OF NURSING SOCIETY, WHEREVER POSSIBLE TO LOOK FOR SYNERGY. CLEARLY WE WANT TO CONTINUE OUR WORK WITH AMERICAN CANCER SOCIETY, UCC, SUSAN COMEN PARTNERSHIP. LANCE ARMSTRONG FOUNDATION AND INTERNATIONAL WORK. CONTINUE PARTNERSHIP WITH THE PHARMA AND BIOTECH INDUSTRY AS WE TRY TO DEVELOP INEXPENSIVE DIAGNOSTICS AS WELL AS IDENTIFY INNOVATIVE MEDICINE THAT CAN BE MADE AVAILABLE AT LOW COST. WE WANT TO STRENGTHEN OUR PARTNERSHIPS WITH OTHER NATIONAL GOVERNMENT SUCH AS MINISTRIES OF HEALTH AND NATIONAL CANCER INSTITUTE. WE CAN BOTH HELP PROVIDE THEM WITH EXPERTISE AS WELL AS BUILD ON INVESTMENT THAT THEY HAVE MADE IN PUBLIC HEALTH AND PUBLIC RESEARCH TO EXPAND THE WORK WE'RE DOING WITH MULTI-LATERAL GOVERNMENT PARTER THIS SHIPS SUCH AS THROUGH OUR WORK WITH THE EUROPEAN COMMISSION. WE HAVE AN EFFORT THAT IS TRANS NIH AS WELL AS INVOLVING OUR CANADIAN COLLEAGUE AND FOCUSED ON WHERE DISEASES AS PART OF THAT TORT WE HAVE GREAT GOOD PILOT PROJECT UNDERGOING TO DEVELOP JOINT TRIALS. AS I MENTIONED WE'RE WORKING CLOSELY WITH A NUMBER OF COUNTRIES IN LATIN AMERICA FOR LATIN AMERICAN RESEARCH NETWORK, WORKING THROUGH OREGON THINK SAKES FOR ECONOMIC COLLABORATION AND DEVELOPMENT TO TRY TO HELP OVERCOME SOME RED TAPE AND REGULATORY BURDENS. ALSO WANT TO HAVE STRONG PARTNERSHIP FOR UNIVERSITY GLOBAL HEALTH. WHERE DO WE ENVISION SCOPE OF GLOBAL CANCER RESEARCH WE SEE IT AS REALLY ACROSS THE CANCER CONTINUUM FROM CANCER BIOLOGY TO CANCER REGISTRIES TO CANCER COMMUNICATION, IMPLEMENTATION. THESE ARE ALL AREAS THAT WE THINK ARE IMPORTANT ON WHICH WE WANT TO WORK TOGETHER WITH COLLEAGUES AROUND THE WORLD. ONE OF THE THINGS THAT WE IDENTIFIED CAN BE A PROBLEM IS IN GRANT REVIEW. JUST HAD E-MAIL ABOUT LAST WEEK FROM AN INVESTIGATOR WHO WAS SENT IN AS A STUDY THAT WAS GOING TO BE DONE IN THE DEVELOPING WORLD AND CONTACTED US, VERY UPSET BECAUSE HIS APPLICATION WAS NERFED BECAUSE NCI DOESN'T FUND INTERNATIONAL RESEARCH. OBVIOUSLY WE NEED TO GET THE MESSAGE THROUGH OUR COLLEAGUES AT CSR TO THE -- FROs TO THE HEAD OF THE STUDY SECTIONS THAT NCI ALL THE OTHER NIH INSTITUTES DO FUND INTERNATIONAL RESEARCH WE WANT STUDY SECTIONS TO PROVIDE BEST SCIENTIFIC REVIEW THEN LET US DECIDE IF IT'S SOMETHING THAT'S APPROPRIATE FOR OUR PORTFOLIO. SO, OUR VISION I THINK WELL SUMMARIZED IN THIS PAPER WHICH CAME UP -- WE HAVE SOME INFORMATION ON OUR WEBSITE, HERE IS MY E-MAIL I CERTAINLY WELCOME YOUR COMMENTS AND QUESTIONS TODAY AND I HOPE THAT YOU'LL STAY IN TOUCH AND GIVE US YOUR IDEAS IN THE MONTHS AND YEARS TO COME. THANK YOU. >> THANK YOU VERY MUCH. CERTAINLY AMBITIOUS AND IMPRESSIVE SET OF ACTIVITIES AND ASPIRATIONS, BOARD DOESN'T HAVE PARTICULAR ISSUE TO VOTE ON BUT AN OPPORTUNITY PROVIDE SOME -- EDUCATE US FOR WANTING TO PROVIDE SOME EARLY FEEDBACK. IF I CAN START WITH ONE QUESTION. YOUR PRESENTATION IT WOULD SEEM THAT STRATEGY THAT YOU HAVE IN MIND TO TOUCH LIGHTLY ON A LOT OF AREAS OF EPIDEMIOLOGY TO DIAGNOSIS TO TREATMENT TUCHUN OCCASION. CLINICAL CARE, BASIC SCIENCE RESEARCH WORLDWIDE. IT WOULD SEEM HARD TO DO ALL OF THOSE THINGS WELL. IS THAT FAIR THAT THAT'S WHAT YOU THINK TOUCH LIGHTLY IN MANY AREAS AS OPPOSED TO -- YOU GOT TO FOCUS ON THIS PART OF THE WORLD OR FOCUS ON LIMITED SET OF ISSUES. WANT TO FOCUS ON CANCER PREVENTION AND CONTROL IN LOW TO MODERATE INCOME COUNTRIES. BUT WE ALSO WANT TO MAKE IT CLEAR THAT ALL NCI DIVISIONS AND CENTERS HAVE BEEN HEAVILY INVOLVED INTERNATIONALLY OVER THE LAST SEVERAL DECADES. SO ONE THING WE THINK THE CENTER NEEDS TO DO HELP COORDINATE THOSE ACTIVITIES TO, HELP GET OUR DIVISION AND CENTERS TO TALK TO ONE ANOTHER. WE HAVEN'T DONE AS GOOD A JOB AS PERHAPS WE SHOULD HAVE. IN TALKING TO ONE ANOTHER. WE MIGHT HAVE DIVISION, IS THAT WERE ALL WORKING THE SAME COUNTRY BUT NOT TALKING TO ONE ANOTHER. WE THINK THAT -- I DON'T ANTICIPATE THE CENTER WOULD BE RUNNING RESEARCH IN ALL THOSE AREAS, WOULD BE RESPONSIBLE FOR MAKING A WAY THAT NCI STAFF TALK TO ONE ANOTHER. >> RESPONSIBLE FOR GETTING THE CENTER GOING MAYBE I CAN JUST ADD COUPLE OF THINGS WHAT TED HAS SAID. THE SCOPE IS BROAD, OBVIOUSLY. THERE IS COORDINATING FUNCTION BUT MY INTENTION TO HAVE SOME FOCUS AND ONE OF THE THINGS THAT TED AND I ARE DOING AT THE MOMENT SETTING UP A MEETING OF SUBSTANTIAL SIZE SOME TIME PROBABLY END OF JANUARY OR EARLY FEBRUARY TO BRING IN MANY FOLKS FROM THESE VARIOUS POTENTIAL PARTNERSHIPS TO THINK ABOUT THINGS THAT WE CAN DO ARE MUCH MORE FOCUSED. THOSE THINGS RANGE FROM TAKING PARTICULAR SCIENTIFIC PROBLEM, VACCINE, FOR EXAMPLE, OR METHODS TO -- SPECIFIC METHODS TO CONTROL TOBACCO IN CERTAIN ENVIRONMENTS. DESIGNATE AS MAJOR PROBLEMS THAT NEED SOLUTIONS THAT WE SHOULD MAKE -- ACTUALLY MAKE INVESTMENTS IN BY COSPONSORING WITH ONE OF THE DIVISIONS THERE ARE SOME PROVOCATIVE QUESTIONS. PICKING UP ON SOME OF THOSE, FOR EXAMPLE, EPIDEMIOLOGY WHAT ACCOUNTS FOR CHANGES IN THE INCIDENTS OF VARIOUS CANCERS, THOSE HAVE QUESTIONS THAT NOT BEEN PURSUED BUT NOTED. WHAT CAN WE DO TO LOOK CLOSELY AT IMPLEMENTATION SCIENCE IN THAT COUNTRY TO TRY TO CHANGE CANCER CARE IN ONE OR TWO PLACES THAT MIGHT BE A WAY OF PROVIDING GUIDANCE TO THE MANY OTHER COUNTRIES THAT ARE GAP ETCHING WITH THE QUESTIONS TO USE RESOURCES. SOMETHING YOU SHOULD LEARN TO MAKE COMMITMENT, BY FAIRLY HEALTHY ECONOMIC AND POLITICAL SITUATION BY THE EXISTENCE OF SOME CANCER CARE ALREADY TRY TO DEVELOP THE TOOLS THAT COULD DRAMATICALLY IMPROVE CANCER IN A FEW COUNTRIES. ONLY FEW OF THE EXAMPLES BUT HOPE IS WHEN WE BRING ALL THE FOLKS THROUGH OUR LIST OF POTENTIAL PARTNERS THOSE ARE PEOPLE IN GROUPS WHO ALREADY HAVE PRETTY LIVELY INVESTMENT IN ONE COUNTRY OR ONE DISEASE OR ANOTHER. AND LOOK THROUGH THE PORTFOLIO THAT EXISTS THINK ABOUT WHAT NEEDS STRENGTHENING, WHAT NEEDS EXPANSION IN TO NEW TERRITORY. >> HI, I'M BETTY FROM CITY OF HOPE AND I'VE BEEN INVOLVED FOR ABOUT TEN YEARS IN A LOT OF GLOBAL EFFORTS IN COLLEGE OF CARE, I WANTED TO JUST REALLY SPEAK TO WHAT I SEE THE OPPORTUNITY TO BE AS PALLIATIVE CARE TO BE MAJOR COMPONENT OF THIS GLOBAL WORK. MUCH OF THE WORK IN THIS AREA HAS BEEN SUPPORTED BY DR. KATHIE FOLEY AND SOCIETY INSTITUTE AND OTHER FOUNDATIONS. BUT MY PARTICULAR PROJECT HAS WORKED NOW WITH -- I MEMBERED THIS MORNING I JUST RETURNED LATE LAST NIGHT FROM BELIZE OUR 71ST COUNTRY. OUR EXPERIENCE IS THAT THESE UNDER DEVELOPED COUNTRY HAVE SUCH HIGH MORTALITY AND THEY ARE EXTREMELY EAGER TO MOVE FORWARD WITH PAIN MANAGEMENT, PARTICULARLY. THERE IS SO MUCH THAT'S BEEN DONE HERE WITHIN CANCER CENTERS IN THE UNITED STATES IN TERMS OF REALLY ADVANCING HOW WE MANAGE PAIN, HOW WE USE VERY INEXPENSIVE DRUGS SUCH AS MORPHINE AND METHADONE, HOW WE CAN TREAT MANY OTHER SYMPTOMS ASSOCIATED WITH DISEASE. MEDICAL SCHOOLS, NURSING SCHOOLS ARE DESPERATELY EAGER IN MOST OF THESE COUNTRIES, WE'VE INVESTED THE LAST THREE DAYS IN BELIZE, IN INVESTED $25,000 IN TRAINING PROFESSIONALS FROM EVERY AREA OF THE COUNTRY AND WORKED WITH THE MINISTER OF HEALTH IN ORDER TO TRY TO ADVANCE DRUG ACCESS IN THAT COUNTRY. THE SAME IS TRUMAN ME OTHER COUNTRIES WE WORKED IN MEDICAL SCHOOLS, NATIONAL CANCER INSTITUTES. AND I JUST RULELY BELIEVE THAT THIS IS SUCH AN ENORMOUS OPPORTUNITY TO REDUCE SYMPTOM BURDEN AND QUALITY OF LIFE ISSUES, THESE COUNTRIES, VERY MUCH APPRECIATE AND THE NEED FOR THESE. THERE ARE LOTS OF ORGANIZATIONS READY AND EAGER TO COLLABORATE WITH YOU AND THESE OF COURSE ARE ALL PEOPLE WHO HAVE NOT ONLY HAD CANCER BUT AIDS, IF YOU BURKE CLOSES, MALARIA, AND DISEASE BURDEN SENESCENCE HIGH. IN YOUR GOALS FOR YOUR GLOBAL OUTREACH. WOULD BE EAGER TO HEPA SAME TATE CONNECTIONS WITH MANY OF THE GROUPS THAT WE WORK WITH. >> COULD I JUST ASK IN THE U.S. IN THE SPHERE OF PREVENTION CONTROL. HOW DO YOU APPROACH THIS ACROSS THE SPECTRUM OF COUNTRIES IS THERE A MANEUVER TO HELP US UNDERSTAND HOW TO PROCEED IN THAT MANNER? >> COMMUNICATION CRITICAL. WE DO HAVE. WE HAVE CANCER INFORMATION SERVICES HELP SET UP A NETWORK SO THAT WE CAN SHARE OUR EXPERTISE ABOUT OUR COMMUNICATION ON CANCER ISSUES. CLEARLY WE NEED TO DO -- HELP FACILITATE RESEARCH THAT IS SPECIFICS ON TERMS OF CHANGING BEHAVIOR AND EXPLAINING HOW BEHAVIOR CREATES RISK OF CANCER, HOW TO ENCOURAGE PEOPLE TO COMPLY WITH SCREENING. WE SEE THIS AS PART OF THE CURRENT RESEARCH PORTFOLIO FOR THE U.S. ALSO HAS RELEVANCE FOR THE REST OF THE WORLD WE WANT TO STIMULATE MORE RESEARCH AND HELP DISSEMINATE THAT RESEARCH AROUND THE WORLD. >> THE LOW HANGING FRUIT OF PREVENTION ARE TWOFOLD. ONE IS TOBACCO CONTROL THE OTHER IS VACCINE. TOBACCO CONTROL IS GOING TO BE VERY MUCH NATION OR REGIONAL SPECIFIC PHENOMENON DEPENDS WHAT KIND OF TOBACCO IS UNDERWAY. IF THERE WAS LOT OF WAY ALREADY INVOLVED, A LOT OF FINANCIAL INTERESTS. ON VACCINE SIDE WE'RE NOT GOING TO PAY FOR VACCINES BUT TRYING TO GET FULLER COMPLIANCE, UNDERSTAND POLICY REASONS AND FINANCIAL REASONS AND BEHAVIORAL REASONS WHY PEOPLE ARE NOT GETTING BACK THE HEPATITIS B VIRUS. EVEN PAPILLOMA VIRUS VACCINE IS CRUCIAL. THIS COUNTRY WE HAVE THREE TO 4,000 DEATHS PER YEAR OF CERVICAL CANCER AND SOME FROM LANE GOAL CANCER THAT MIGHT BE REHAVEN'TIBLE. I MENTIONED THE AGREEMENT PROVIDING TREMENDOUS EXAMPLE OF HOW PAPILLOMA VIRUS VACCINE CAN GET TO IMPOVERISHED POPULATION. NEED TO STUDY THAT AND WORK WITH LOT OF COUNTRIES AND POTENTIAL PROVIDERS OF SOME POLITICAL AND ECONOMIC RESOURCES TRYING TO MAKE THAT HAPPEN ELSEWHERE. ONE OBVIOUS THING TRYING TO HELP BUILD PRODUCTION VARIETIES BUT TRY TO STUDY THE PROBLEM, GETS US IN TO POLICY DOMAIN THAT NOT NOVEL TO THE NCI. CHANCE YOU HAVE BROUGHT TO DO SOME THINGS THAT INVOLVE STUDYING HOW INDIVIDUAL COUNTRIES APPROACH THEIR CANCER BURDEN THAT COULD BE VERY BENEFICIAL ACROSS A RANGE OF ISSUES AND SIMILAR SITUATIONS. >> OTHER COMMENTS, QUESTIONS? >> SEEMS TO ME THAT THERE IS SPECIAL OPPORTUNITY TO THINK ABOUT COLLABORATIONS WITH SOME OF THESE OTHER COUNTRIES AROUND CANCER PREVENTION NOT SIMPLY, FOR EXAMPLE, VACCINATION AGAINST HPV AND HEPATITIS BUT TO UNDERSTAND WHY IS IT REALLY THAT IF YOU HAVE HEPATITIS C INFECTION, FOR EXAMPLE, YOU'RE AT RISK FOR DEVELOPING -- MAYBE NOT HUGEST CANCER BURDEN IN THIS COUNTRY BUT I'M SURE IF WE REALLY UNDERSTOOD THAT, THAT WOULD INFORM HOW TO THINK ABOUT CANCER PREVENTION IN OTHER -- AS WELL. STUDYING HIGH RISK PATIENT POPULATIONS SEEMS LIKE THAT COULD BE VERY USEFUL. >> ONE COMMENT ABOUT THE ROLE OF BS A IN THIS REASON. THETH CA B TAKES AN INTEREST IN THIS TOPIC. UNIVERSITY OF CHICAGO WHO IS ORIGINAL FROM NIGERIA HAS BEEN CHAIRING A SUBCOMMITTEE OF N CA B THAT IS FOCUSED ON GLOBAL HEALTH -- WE HAVE WORKSHOP IN THE WINTER AND IF ANY OF YOU ARE PARTICULARLY INTERESTED IN HOW TO FOCUS OUR ENERGIES ON BROAD LIST OF TOPICS THAT WOULD BE GREAT BECAUSE I DO WANT TO HAVE BOTH NCAB AND BS A INVOLVED. NO DOUBT THAT YOU'LL BE CALLED ON FAIRLY SOON TO APPROVE RFAs THAT COME FROM COLLABORATION BETWEEN THE CENTER AND DIVISION HAVING GROUP HERE THAT IS FOCUSED ON DIFFICULTIES OF MAKING SOME OF THESE DECISIONS BEFORE THEY'RE BROUGHT TO YOU WOULD BE VERY HELPFUL. >> THANK YOU VERY MUCH. OKAY, LAST REMAINING FEW MINUTES WE HAVE OPPORTUNITY TO GET SOME FEEDBACK FROM THE BOARD AROUND THE PROCESS BY WHICH WE PREPARED FOR THIS MEETING AS YOU KNOW ALL OF THE RFA-RELATED MATERIALS MADE AVAILABLE TO US ONLINE AS OPPOSED TO BEING MAILED TO US IN PAPER. WOULD BE GOOD IDEA TOUSLES SUBMIT FEEDBACK AS TO -- WERE YOU SATISFIED WITH THAT. ARE YOU THINGS THAT YOU THINK THE WEBSITE MAKE IT EASIER NOR YOUR JOB? OR ARE YOU TOO EXHAUSTED TO EVEN COMMENT? >> I THOUGHT THE WEBSITE WAS VERY EASY TO USE. MATERIALS WERE EASY TO DOWNLOAD. IT WAS -- OBVIOUSLY MY FIRST MEETING BUT VERY STRAIGHT FORWARD AND I CAN'T IMAGINE CARTING AROUND THESE NOTEBOOKS WHEN YOU CAN HAVE THAT. [ NOT AUDIBLE ] >> ALSO WANTED TO THROW OPEN IF THERE WERE ANY OTHER IDEAS FOR AGENDA TOPICS THAT HAROLD MENTIONED THE LONG LIST THIS MORNING BUT THERE ARE PROBABLY OTHERS AND IF YOU WANT TO THROW OUT ANY OF THOSE NOW YOU CAN DO THAT OR E-MAIL PAULA OR ME WITH THOSE IDEAS AS THEY COME TO YOU. ANY HER ISSUES? ALL RIGHT. I THINK WE'RE DONE. THANK YOU EVERYBODY.